cyrilzakka/clinical-trials huggingface dataset:
Role of FDG-PET CT in the Management of Muscle Invasive Bladder Cancer

Bladder cancer is the seventh cause of cancer mortality in France. Overall survival is poor, between 45 and 50% at 5 years.

Optimal staging of lymph nodes and metastasis is crucial for treatment decision of muscle invasive bladder cancer (MIBC).

Guidelines do not recommend FDG-Positron Emission Tomography (PET) Computed Tomography (CT), but rather CT for lymph node and metastatic staging, despite its low accuracy. We performed a retrospective analysis of patients undergoing PET CT for localized MIBC in two centers, to help define the utility of PET CT in this setting.

Background:

Bladder cancer is the second most frequent genito-urinary cancer, and the seventh cause of cancer mortality in France. Overall survival is poor, between 45 and 50% at 5 years. Curative treatment of muscle invasive urothelial carcinoma localized to the bladder includes cisplatin-based neoadjuvant chemotherapy, followed by radical cystectomy with lymph nodes dissection. Nonetheless, surgery indications depend on pre-operative staging regarding nodes and metastatic involvement.

Computed Tomography (CT) scan is the reference imaging study for loco-regional and metastatic staging. Lymph node involvement evaluation is based on morphologic criteria only. Its sensitivity lies between 30 and 53% and its specificity between 67 and 91%. Yet, optimal node staging is crucial for therapeutic decision.

FDG-Positron Emission Tomography (PET) CT, using both morphologic and functional criteria, could help for node staging in muscle invasive bladder cancer assessment, especially by detecting infracentimetric involved lymph nodes. Moreover, it could be useful for detecting distant metastasis.

Objective:

To evaluate the accuracy of the PET CT for lymph node staging and to determine the rate of treatment modification according to PET CT results

Methods:

Retrospective study based on the medical records of every patient undergoing a PET CT at the time of diagnosis of MIBC from 01/2005 to 12/2017 in Bordeaux (Bergonie Institute and University Hospital). PET CT could have been done before any treatment (PET 1) and/or after neo-adjuvant chemotherapy and before surgery (PET 2).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Muscle Invasive Urothelial Carcinoma of the bladder (classified at least pT2 on TURB)
* Diagnosis between January 2005 and December 2017
* PET CT done during initial assessment before surgery (at the time of diagnosis and/or after neoadjuvant chemotherapy)
* Management of cancer at Institut Bergonié or at Bordeaux University Hospital
* Previous treatment for Non Muscle Invasive Bladder Cancer allowed

Exclusion Criteria:

* Management of cancer outside of Institut Bergonié or Bordeaux University Hospital
* No PET CT done during initial assessment (before surgery)
* Rare pathological type of bladder cancer without urothelial carcinoma (epidermoid carcinoma, neuro-endocrine carcinoma, ...)
* Extra-vesical urothelial carcinoma
Prospective Memory in Parkinson's Disease

The investigators tested whether prospective memory is impaired in individuals with Parkinson's Disease compared to controls using reliable and validated experimental measures. Also, the investigators assessed the impact of Parkinson's medication on prospective memory performance in PD to better estimate prospective memory function in PD patients' everyday (chronically treated) life.


Eligibility Criteria:
Inclusion Criteria:

* PD Group:

  * Clinically definite PD
  * 40-70 years old
  * Hoehn and Yahr stage I,II,III
  * Currently treated with Levodopa/carbidopa
* Control Group:

  * 40-70 years old
  * Spouses of PD Group preferred

Exclusion Criteria:

* PD Group and Control Group:

  * Significant neurological problems
  * Significant current psychiatric diagnoses
  * Mini Mental Status Exam score \< 24 (MMSE)
  * Any significant abnormality on brain imaging
  * MPTP exposure
  * Control Participants met the same exclusion criteria described above as well as a biological family history of PD
A Head-to-head Comparative Study of 18F-PSMA-1007 PET/CT and 18F-FDG PET/CT Imaging in Multiple Myeloma

Multiple myeloma (MM) is the second most common hematological malignancy and is still incurable. Positron emission tomography/computed tomography (PET/CT) has been used to diagnose, assess treatment response, and predict prognosis in MM. 18F-fluorodeoxyglucose (FDG) is the most widely used radiotracer, but there is heterogeneous uptake in MM, that is, uptake is negative in some myeloma cells. There are currently reports of cases with strong uptake of prostate-specific membrane antigen (PSMA) PET/CT in MM. Therefore, this preliminary study was designed to compare the imaging results of 18F-PSMA-1007 PET/CT and 18F-FDG PET/CT, and to evaluate the additional value of 18F-PSMA-1007 PET/CT to 18F-FDG PET/CT in MM.

18F-fluorodeoxyglucose (FDG) PET/CT can identify bone lesions, assess disease burden, and detect extramedullary lesions in multiple myeloma(MM), but due to MM is a complex and heterogeneous disease , 18F-FDG PET/CT has heterogeneous uptake in MM bone lesions, resulting in false negative results in the diagnosis of MM bone disease, then affecting the diagnosis, staging and evaluation of the response to treatment of MM. Prostate-specific membrane antigen (PSMA) is a specific membrane-bound glycoprotein, recently high uptake in PSMA PET/CT in MM bone lesions has been published in case reports, thus PSMA PET CT imaging may have potential value for multiple myeloma. There are no head-to-head studies comparing 18F-PSMA-1007 PET/CT with 18F-FDG PET/CT in multiple myeloma. Therefore, this study intends to compare the detection rate of lesions by 18F-PSMA-1007 PET/CT and 18F-FDG PET/CT in MM , and to evaluate the additional value of 18F-PSMA-1007 PET/CT to 18F-FDG PET/CT in multiple myeloma.

Eligibility Criteria:
Inclusion Criteria:

* confirmed untreated or relapsed multiple myeloma patients;
* 18F-PSMA-1007 and 18F-FDG PET/CT within one week;
* signed written consent;
* no combined other Malignant tumors.

Exclusion Criteria:

* suffered from arthritis or combined with other malignant tumors;
* received myeloma-related therapy within 3 months before PET/CT imaging
* any medical condition that in the opinion of the investigator may significantly interfere with study compliance.
The Effect of Drinking-Water pH on the Human Gut Microbiota

This study evaluates the effect of alkaline (pH=9) versus neutral (pH=9) drinking-water on the gut microbiota of healthy male volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Male
* Non-smoker
* Age 18 - 35 years
* Weight stabile for at least 2 months
* BMI between 20.0 - 27.0 kg/m\^2

Exclusion Criteria:

* Habitual consumption of caloric or artificially sweetened beverages in excess of 1L/week
* Habitual average consumption of alcohol in excess of 7 drinks/week
* Antibiotic treatment within two months of inclusion
* Chronic or acute illness
* Previous abdominal surgery
Multicenter Prospective Observational Study Evaluating the Management of Heart Failure

ADAPTATION HF is a prospective, observational, cross-sectional, multicenter, survey-based study. Patients who applied to the cardiology outpatient clinic with a preliminary diagnosis of HF or were hospitalized for HF and had a diagnosis of HF for at least 6 months will be included in the study.

ADAPTATION HF is a prospective, observational, cross-sectional, multicenter, survey-based study. Patients who applied to the cardiology outpatient clinic with a preliminary diagnosis of HF or were hospitalized for HF and had a diagnosis of HF for at least 6 months will be included in the study. Data entry staff who will be assigned to the centers for 2 weeks will apply a questionnaire consisting of different questions to the patients referred to them by clinicians with the diagnosis of HF. In addition, Pittsburg Sleep Quality Index will be applied to all cases. In addition, clinical features of HF from the current file of the cases (NYHA, comorbid conditions, comorbid diseases, blood pressure, heart rate, last drugs used, latest biochemistry (BNP/NTproBNP if available), hematology test results, most recent ECG , most recent echocardiography, coronary angiography report, if available) will be recorded. No additional examination/procedure will be performed for the study, only the data of the examinations requested by the clinician in routine clinical practice will be entered. A total of 500 patients from 10 centers will be included in this study over a six-month period.

Eligibility Criteria:
Inclusion Criteria:

* Outpatient or inpatient diagnosed with Heart Failure at least 6 months ago
* Male or female patient aged 18 and over
* Signed written informed consent form

Exclusion Criteria:

* newly diagnosed heart failure
* CRY requiring dialysis
* Serious liver and lung disease
* LVAD/heart transplantation
* HF due to possible temporary cause (myocarditis, peripartum CMP in the first 6 months, takotsubo etc.)
Clinical Characteristics and Outcomes of Relapsed Follicular Lymphoma After Autologous Stem Cell Transplantation at Rituximab Era

Introduction High dose chemotherapy followed by Autologous Stem Cell Transplantation (ASCT) is a therapeutic option in follicular Lymphoma after first line treatment failure. The clinical characteristics and outcome of FL patients who relapsed after HDT+ASCT and therapeutic management in the rituximab era are not well known and may represent a difficult challenge.

Patients and Methods: The investigators conducted a retrospective analysis of FL patients who relapsed after HDT+ASCT in four French centers treated between 2000 and 2014. Clinical records were reviewed for clinical characteristics and treatment strategy at relapse. The investigators aimed to identify prognostic factors related to patient's outcome.


Eligibility Criteria:
Inclusion Criteria:

* they were older than 18 years
* presented FL at diagnosis (Grade 1, 2, or 3a).
* received high-dose therapy (HDT) with ASCT from 2000 to 2014

Exclusion Criteria:

1. they had already been treated with a 1st ASCT,
2. had a previous history of histological transformation before ASCT
3. if they were rituximab naive prior to ASCT.
Barbed-suture Efficiency Study for Sacrocolpopexy

Minimally invasive sacrocolpopexy (SCP) performed laparoscopically or with robotic assistance is associated with improved patient-centered outcomes such as faster recovery times, less pain, less bleeding, and shorter hospital stay, however at the expense of longer operating times. One of the time consuming parts of the procedure is vaginal mesh attachment.

The purpose of this research study is to compare two different suture types that are used to attach vaginal mesh that is typically used in women undergoing robotic or laparoscopic sacrocolpopexy (attachment of the vagina to the sacral promontory). The barbed suture is one continuous suture, while the delayed absorbable suture involves placing individual sutures and tying a knot for each. All women will have permanent sutures that attach the mesh to the sacral promontory, which is standard of care. The goal is to determine if the barbed delayed absorbable suture decreases the time of vaginal mesh attachment.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥21
* Subject must have apical with anterior or posterior vaginal prolapse with leading edge of prolapse to or beyond the hymen
* Subject reports a bothersome bulge they can see or feel per Pelvic Floor Disability Index (PFDI-20), question 3, response of 2 or higher
* Eligible for laparoscopic or robotic sacrocolpopexy
* Desires surgical treatment for symptomatic uterovaginal or vaginal vault prolapse
* English speaking

Exclusion Criteria:

* Patients who are not surgical candidates due to medical comorbidities
* Current foreign body complications (including but not limited to erosion, fistula, abscess). This covers foreign bodies of any type (e.g. synthetic and biologic including allograft, xenograft).
* Inability to give informed consent or to complete the testing or data collection.
* Anticipated circumstances resulting in an inability to follow up (geographic relocation, etc.).
* Active systemic infection including any gynecologic infection, untreated Urinary Tract Infection (UTI) or tissue necrosis.
* History of pelvic organ cancer (e.g. uterine, ovarian, bladder, or cervical).
* Prior or currently undergoing radiation, laser therapy, or chemotherapy in the pelvic area.
* Subject has taken systemic steroids (within the last month, steroid inhalers OK), or immunosuppressive or immunomodulatory treatment (within the last 3 months)
* Systemic connective tissue disease (e.g. scleroderma, Marfan's syndrome, Ehlers Danhlos, collagenosis, polymyositis or polymyalgia rheumatic, lupus)
* Chronic systemic pain that includes the pelvic area or chronic focal pain that involves the pelvis
* Poorly controlled diabetes mellitus (DM), as indicated by Hemoglobin A1c \> 9
* Those requiring concomitant rectopexy
* Subject is not able to conform to steep Trendelenburg position
* Known sensitivity to polypropylene
* History of prior prolapse repair utilizing vaginal or abdominal mesh
* Planned vaginal mesh attachment placed transvaginally
* History of diverticulitis
Fatty Acids and Executive Function Development in 7-12 Year Olds

Purpose: To examine the effect of the omega-6 to omega-3 fatty acid ratio on age-related changes in executive functions in children and older adults.

Participants: Eighty-four typically-developing 7-to 12-year-old children.

Procedure (methods): Participants and a caregiver will participate in 4 sessions. Three sessions will consist of the screening. These sessions will be telephone calls to collect 24-hour diet information that will be used to determine whether they are eligible for the fourth session. Approximately 120 participants will be screened to find 84 participants who are eligible for the fourth session, in which participants will complete a series of tests on the Cambridge Neuropsychological Test Automated Battery (CANTAB) - a touch-screen device that provides computerized versions of standardized cognitive tests. They will also complete a maze task in which they figure out a path through the maze by walking on the correct squares. Brain activity will be recorded using a portable near-infrared spectroscopy (NIRS) system.


Eligibility Criteria:
Inclusion Criteria:

* Typically-developing children 7-12 years old

Exclusion Criteria:

* Children or parents who do not speak English
* Any diagnosis of a psychological illness
* History of seizures
* History of tobacco exposure during gestation
* History of alcohol exposure during gestation
Endometrial Volume and Sub-endometrial Vascularity as Predictors of In-vitro Fertilization Success

100 patients aged 21-40 years old, diagnosed as primary or secondary infertility These patients are then assigned to receive ICSI treatment (ovulation induction, . They undergo a 3D vaginal ultrasound before treatment to measure the junctional zone thickness and followed up after treatment to determine the rate of implantation.

Intervention(s) All patients will undergo 3D ultrasound to measure the thickness of the junctional zone at day 21 of the cycle.

100 patients aged 21-40 years old, diagnosed as primary or secondary infertility due to the following causes of infertility; ( Pelvic Inflammatory disease, dysovulation , tubal infertility, unexplained infertility, combined infertility or due to male factor ). These patients are then assigned to receive fertility treatment (ICSI) They undergo a 3D vaginal ultrasound before treatment to measure the junctional zone thickness and followed up after treatment to determine the rate of implantation.

Intervention(s) All patients will undergo 3D ultrasound to measure the thickness of the junctional zone at day 21 of the cycle.

Eligibility Criteria:
Inclusion Criteria:

* A normal transvaginal ultrasound is defined as having no visible intracavitary pathology (e.g. submucous myomas, polyps or septa) and was be performed in the follicular phase of the menstrual cycle. Intramural myomas without impression or deformation of the uterine cavity were incorporated in the definition of a normal ultrasound

Exclusion Criteria:

* Exclusion criteria included Females aged above 40 years old , patients with endometriosis, abnormal endocrine functions as Diabetes mellitus, thyroid disorders and adrenal abnormalities ,general diseases, those with ovarian cysts or have azospermic partners
Cognitive Behavior Therapy vs Exposure in Vivo in the Treatment of Panic Disorder With Agoraphobia

Panic disorder with agoraphobia is a prevalent and one of the most handicapping anxiety disorders. Although the efficacy of psychological treatment for panic disorder with agoraphobia has been the subject of a great deal of research, studies comparing cognitive-behavioral therapy and exposure in vivo have regularly been underpowered to detect small to moderate differences. Therefore, the primary purpose of the present study is to investigate if the combination of cognitive techniques with exposure in vivo is superior to the effects of exposure alone for patients with moderate to severe agoraphobia.

Anxiety disorders are the most common group of mental illnesses, with lifetime prevalence estimates ranging between 10-30% (Kessler et al 2007). They are an economic burden on society and the sixth largest cause of disability globally (Baxter et al 2014; Fineberg et al 2013). Suffering from an anxiety disorder is distressing, with affected individuals reporting adverse effects on quality of life comparable to sufferers of major depressive disorder, and in excess of the population norm (Mendlowicz and Stein 2000). Panic disorder with agoraphobia is especially prevalent and one of the most handicapping anxiety disorders.

Although the efficacy of psychological treatment for panic disorder with agoraphobia has been the subject of a great deal of research (Sanchez-Meca, Rosa-Alcazar, Marin-Martinez \& Gomez-Conesa, 2010), studies comparing cognitive-behavioral therapy and exposure in vivo have regularly been underpowered to detect small to moderate differences.

Therefore, the primary purpose of the present study is to investigate if the combination of cognitive techniques with exposure in vivo is superior to the effects of exposure alone for patients with moderate to severe agoraphobia. Participants suffering from panic disorder, agoraphobia receive exposure-based treatment with elements of cognitive restructuring (CBT-group) or without such elements (Exposure-only group) delivered according to treatment manuals and in individual sessions with a maximum of 30 sessions á 50 minutes. Both treatments cover psychoeducation on the nature of anxiety and panic, interoceptive and intensified situational exposure exercises. In the CBT group identification and correction of maladaptive thoughts about anxiety and its consequences is furthermore part of the treatment package.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of panic disorder with agoraphobia by trained clinician using a structured interview
* The anxiety disorder is considered to be the patient's main current problem
* Age between 18 and 65 years
* The patient has agreed to participate in the study

Exclusion Criteria:

- Diagnosis of bipolar disorder, psychotic disorder, alcohol/substance abuse or dependency (within past 3 months), prominent risk of self-harm, organic mental disorder; concurrent psychotherapeutic or psychopharmacological treatment
The Effect of High Intensity Laser on Muscle Quality and Pain in Those With Low Back Pain

The purpose of this study is to evaluate the effects of CureWave laser on paraspinal muscle oxygenation, pressure pain thresholds, muscle edema, and quality, and perceived outcomes in patients with chronic low back pain.

Low back pain (LBP) contributes to disability and has a significant economic impact. High intensity laser devices are class 4 producing \> 40 W of power at longer wavelengths, thereby allowing deeper tissue penetration. Currently, there is little evidence to demonstrate the effectiveness of high intensity laser treatment in those with chronic LBP. Optimal dosing strategies are still unknown as well as patient response based on chronicity of symptoms. Therefore, our study seeks to evaluate the effectives of high intensity laser therapy using CureWave in those with LBP of a duration longer than 3 months and with a dosing strategy of two times/week for three weeks.

Hypothesis

1. CureWave laser therapy will increase total oxygenated hemoglobin and muscle blood flow in patients with chronic LBP.
2. CureWave laser therapy will reduce inflammation as assessed by muscle edema in patients with chronic LBP.
3. CureWave laser therapy will improve paraspinal echogenicity (muscle quality) following treatment in patients with chronic LBP.
4. CureWave laser therapy will decrease muscle sensitivity in patients with chronic LBP
5. CureWave laser therapy will demonstrate improve patient reported outcomes, including decreased pain, reduced disability and improved function in patients with chronic LBP.
6. CureWave laser therapy will increase muscle activation during maximal strength testing.
7. CureWave laser therapy will decrease performance fatigability as assessed by maximal muscle activation and force production.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-65
* Self-reported history of low back pain (5 episodes in lifetime or 3 in last three years which altered activities of daily living)13

Exclusion Criteria:

* Self-reported pregnancy
* Inability to complete all required meeting sessions
* Known cardiovascular, pulmonary, metabolic, muscular, and/or coronary heart disease
* Regularly uses prescription medication
* Seeking medical care for the current episode of low back pain
* Report average symptoms greater than 8/10
* Inability to perceive light touch.
* Verbal reports of known cardiovascular, pulmonary, metabolic, muscular, and/or coronary heart disease
* Verbal reports of known skin sensitivity to gels or adhesives.
GABA-glutamate Interactions and Psychosis

This study investigates the interactions between NMDA (N-Methyl-D-aspartic acid) antagonism and GABA (gamma-aminobutyric acid) system as it relates to cognitive function assessed by ERPs (event-related potentials) in healthy volunteers.


Eligibility Criteria:
Inclusion criteria:

* Ages of 21-45 years from all ethnic backgrounds.
* Male or female.
* Written informed consent.

Exclusion criteria:

* DSM-IV diagnosis for a psychotic, depressive or anxiety disorder.
* A history of significant medical/neurological disease such as cardiac, thyroid, renal, hepatic abnormality, seizure disorder. Unstable medical condition based on EKG, vital signs, physical examination and laboratory work-up (CBC with differential, SMA-7, LFTs, TFTs, UA, Utox).
* History of abnormal EEG.
* History of severe allergies or multiple adverse drug reactions.
* Any medication that could interfere with either the safety of the study and/or the outcome measures.
* Any other conditions which in the opinion of the investigator would preclude participation in the study.
* History of major psychiatric disorder in first degree relatives.
* Current substance abuse/dependency determined by urine toxicology.
* Treatment with medications with CNS effects.
* Treatment with benzodiazepines within one week prior to testing.
* Current treatment with medications with psychotropic effects.
* Education \< 10th grade.
* IQ \< 70, MR.
* Non-English speaking.
PFx Closure System in Subjects With Cryptogenic Stroke, TIA, Migraine or Decompression Illness

The primary object of this study is to demonstrate the continued safety and performance of the PFx Closure System when utilized for patients with PFOs suffering from cryptogenic stroke, transient ischemic attack, migraine or decompression illness.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 65 years old
* PFO with one or more of:

  * Cryptogenic stroke,
  * TIA or embolism,
  * History of severe migraine headaches, or
  * History of severe decompression illness.

Exclusion Criteria:

* In appropriate anatomy (vascular or cardiac) or inappropriate medical condition for PFO closure and study medications.