cyrilzakka/clinical-trials huggingface dataset:
18F-DCFPyL PET/CT Impact on Treatment Strategies for Patients With Prostate Cancer

The main purpose of this phase II trial study is to determine whether a positron emission tomography (PET)/computed tomography (CT) scan using 18F-DCFPyL affects the clinical management plan in Veterans.

In this study, the management plan prior to and after 18F-DCFPyL PET/CT will be recorded by specific questionnaires and corresponding changes in management will be analyzed. The scan will be used to see how the disease has spread. Both the treatment strategies and probable disease outcomes as relevant to clinical endpoints will be assessed. This study is open to Veterans only.


Eligibility Criteria:
Inclusion Criteria:

* Participants who fulfill criteria for initial staging or restaging as outlined below:

  1. Initial treatment strategy decisions (initial staging)

     All participants with histologically proven prostate cancer or strong suspicion of prostate adenocarcinoma based on very high PSA levels (\>50 ng/mL) who require an initial treatment/management decision who may be candidate for any of the following strategies:

     A) Surgery B) External radiation therapy (RT) C) Other focal therapies D) Systemic medical treatment E) Watchful waiting
  2. Assessment for Subsequent treatment strategy (restaging), any of the following:

A) Participants with biochemical recurrence who are potential candidates for any salvage treatment. Biochemical recurrence is defined by rising PSA after definitive therapy with prostatectomy or radiation therapy, as any of the following:

1. Post radical prostatectomy (RP): PSA equals to or greater than 0.2 ng/mL measured more than 6 weeks after RP
2. Post-radiation therapy : Nadir + greater than or equal to 2 ng/mL rise in PSA B) Participants with known prostate cancer who undergo restaging because of new symptoms C) Participants with known metastatic prostate cancer who undergo restaging because of rising PSA with negative or inconclusive conventional imaging D) Participants with known prostate cancer who are treated medically or with RLT in whom response to treatment is assessed

   * Capability to provide written informed consent
   * Able to remain still for duration of each imaging procedure (about 30 minutes) \* Participants may be reenrolled in the study, if 18F-DCFPyL PET/CT is performed for subsequent management decision.

Exclusion Criteria:

* Less than 18 years-old at the time of radiotracer administration
* Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)
* Any additional medical condition, serious concurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance.
* Inability to provide written informed consent
Measurement of the Clinical and Radiological Performance Impact of the Root Canal Treatment With BioRootTM RCS.

The aim of this retro-prospective Post-Market Clinical Follow-Up (PMCF) study is to collect long term clinical and safety data on root canal obturation after treatment, or retreatment, by BioRootTM RCS. The patients included in the study had received BioRootTM RCS 5 years ago. Participants will be followed prospectively at 5 and 10 years after root canal treatment.

Clinical data, radiographic data, adverse events (safety) and device performance will be collected by the dentist from the inclusion visit until the end of the study.


Eligibility Criteria:
Inclusion Criteria:

* Patient, male or female, \> 18 years of age at the time of inclusion in the study.
* Patient who had a non-surgical root canal treatment with BioRootTM RCS, in a context of an endodontic treatment, or retreatment, 5 years (± 6 months) ago.
* All roots of the investigational teeth were treated with BioRootTM RCS.
* Having a documented retro-alveolar radiography immediately after root canal obturation.
* Patient affiliated or beneficiary of a social security system.
* Patient has signed his/her informed consent form.

Exclusion Criteria:

* History of malignant tumors in the 5 years prior to the root canal treatment.
* Non-stabilized systemic disease during the month prior to the root canal treatment (diabetes, hypertension, thyroid disorders, etc.).
* Patient who developed a systemic pathology after the root canal treatment with BioRootTM RCS.
* The Root canal treatment with BioRootTM RCS is on a wisdom tooth.
* Tooth presenting an advanced periodontal disease (parodontal pocket ≥ 5mm or bone loss ≥ 50%).
The Efficacy of Urine Biomarker in Patient With Interstitial Cystitis/Painful Bladder Syndrome (Pilot Study)

This study is to evaluate the efficacy of urine biomarker in patients with interstitial cystitis/painful bladder syndrome


Eligibility Criteria:
Inclusion Criteria:

1. must have experienced bladder pain, urinary urgency and frequency for at least 6 months prior to entry into the study
2. Pain VAS \>4
3. PUF score \>13
4. ICQ score \>12

4) cystoscopic record within 2years

Exclusion Criteria:

1. Patients who are pregnancy or, childbearing age without no contraception
2. Patient with microscopic hematuria, if not excluded that no evidence of neoplastic tumor examination
3. patients with urine culture showing evidence of urinary tract infection 1month prior to the study
4. Accompanied medical problem below

   * Tuberculosis in urinary system
   * Bladder cancer, urethral cancer, Prostate cancer
   * Recurrent cystitis
   * Anatomical disorder
5. Patients had prior surgery (bladder augmentation, cystectomy)
6. Patients with neurologic disorder
7. Patients with indwelling catheter or intermittent self-catheterization
8. Patients with psychological problem
Comparison of Lymph Drainage and Connective Tissue Massage in Fibromyalgia Patients

The present study was designed to analyze and compare the effects of Manual Lymph Drainage Therapy and Connective Tissue Massage in females with Fibromyalgia (FM).

The lack of specific disease mechanisms is reflected in the fact that no cure has been found for the disease. Thus, the many interventions which are advocated in FM are targeted against the more general characteristics of pain and disability. Current pharmacological interventions have limited efficacy. There is an increasing consensus that therapy should also include non-pharmacological approaches. Manual therapy techniques are composed of a variety of procedures directed at the musculoskeletal structures in the treatment of pain. Two major subcategories exist that divide these techniques into those which produce joint motion and those which do not. The first subcategory includes manipulation, mobilization, and manual traction. The second subcategory involves both generalized soft tissue therapies, such as the many types of massage, and focal soft tissue therapy (10).

Consequently, there is currently no recognized effective treatment for FM patients. In addition, there is limited number of study dealing with the effect of manual therapy techniques on FM. Although, there were some studies about Manual Lymph Drainage Therapy (MLDT) and Connective Tissue Massage (CTM) in FM. There wasn't found any study concerning the comparison of the effects of MLDT and CTM. In this study, MLDT and CTM were used for FM, which are included in the second subcategory of manual therapy techniques.

Based on positive results of some studies about MLDT and CTM in FM, this study was planned to test and compare the effects of MLDT and CTM in terms of pain, health status and HRQoL in females with FM using a randomized control trial.

Eligibility Criteria:
Inclusion Criteria:

* female outpatients
* being ≥ 25 years or older
* being met the criteria for FM as defined by the American College of Rheumatology
* having pain with the onset at least 3 months before baseline visit
* pain in the neck or shoulder region
* have never been treated for FM
* being volunteer for participating

Exclusion Criteria:

* pain from traumatic injury or structural or regional rheumatic disease,
* chronic infection,
* fever or an increased tendency to bleed,
* severe physical impairment,
* signs of tendinitis,
* cardiopulmonary disorder,
* inflammatory arthritis,
* autoimmune disease,
* uncontrolled endocrine disorder,
* allergic disorder,
* pregnancy or breast-feeding,
* malignancy,
* unstable medical or psychiatric illness or medication usage.
* They were asked not to use antidepressant, myorelaxant, and non-steroid anti-inflammatory drugs during three days before the first appointment and the treatment sessions and the evaluation process after the treatment.
Study of Immune Globulin Intravenous (Human) GC5107 in Subjects With Primary Humoral Immunodeficiency

The purpose of this study is to evaluate the safety, efficacy and Pharmacokinetics of Immune Globulin Intravenous (Human) GC5107 in subjects with Primary Humoral Immunodeficiency (PHID).

This was a prospective, open-label, single-arm, historically controlled, multicenter phase 3 study measuring the safety, efficacy and pharmacokinetics and tolerability of GC5107 in subjects with Primary Humoral Immunodeficiency disease (PHID).

Subjects received intravenous infusions of the investigational product at the same dose and interval as used for their previous Immunoglobulin intravenous (IVIG) maintenance therapy. GC5107 was administered every 21 or 28 days for a period of 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Subject with a confirmed clinical diagnosis of a Primary Humoral Immunodeficiency Disease as defined by IUIS (International Union of Immunological Societies) and require treatment with IGIV. Documented agammaglobulinemia or hypogammaglobulinemia
* Male or Female, ages 2 to 70 years
* The subject has received 300-900 mg/kg of a licensed IGIV therapy at 21 or 28 day intervals for at least 3 months prior to this study
* At least 2 documented IgG trough levels of ≥ 500 mg/dL are obtained at two infusion cycles (21 or 28 days) within 12 months prior to study enrollment

Exclusion Criteria:

* Subject has secondary immunodeficiency
* Subject was newly diagnosed with PHID and has not yet been treated with immunoglobulin
* Subject has been diagnosed with dysgammaglobulinemia or isolated IgG subclass deficiency or isolated IgA deficiency with known anti-IgA antibodies
* History of severe reaction or hypersensitivity to IGIV or other injectable form of IgG
* Subject has a lifetime history of at least one thrombotic event including deep vein thrombosis, cerebrovascular accident, pulmonary embolism, transient ischemic attacks, or myocardial infarction
* Subject has received blood products other than human albumin or human immunoglobulin within 12 months prior to enrollment
Strongest Families (Formerly Family Help Program): Pediatric Attention Deficit/Hyperactivity Disorder

The purpose of the Strongest Families (formerly Family Help Program)is to evaluate the effectiveness of the Strongest Families distance intervention compared to usual or standard care that is typically provided to children with mild to moderate Attention Deficit/Hyperactivity Disorder. This is a single-centre trial based at the IWK Health Centre. The primary outcome is change in diagnosis.

The purpose of the Strongest Families (formerly Family Help Program): is to deliver, primary care mental health services to children and their families in the comfort and privacy of their own home. Approximately 60 children (8-12 years of age)suffering from mild to moderate (but clinically significant) symptoms of pediatric Attention Deficit/Hyperactivity Disorder will be randomized.

The intervention is delivered from a distance, using educational materials (manuals, video-tapes, audio-tapes) and telephone consultation with a trained paraprofessional "coach" who is supervised by a licensed health care professional. The telephone coach delivers consistent care based on written protocols, with on-going evaluation by a professional team.

Fifty percent of the eligible participants will receive Strongest Families (formerly Family Help Program): telephone-based treatment and 50% will be referred back to their family physician to receive standard care as determined by that physician. Those receiving standard care will be evaluated for outcome results and then compared to the Strongest Families treated participants. It is anticipated that Strongest Families treatment will be proven to be as or more effective than standard care.

Eligibility Criteria:
Inclusion Criteria:

* child 3 to 7 years of age
* child had behavioural problems for 6 months or longer
* access to a telephone in the home
* speak and write english
* mild to moderate attention deficit/hyperactivity symptomology

Exclusion Criteria:

* severe attention deficit/hyperactivity symptomology
* received similar intervention within past 6 months
* Autism or Schizophrenia
* child has intellectual impairment
Quality of Life and Symptom Management in Patients With Bladder Cancer

RATIONALE: Learning about quality of life and symptom management in patients with bladder cancer may help doctors learn about the effects of treatment and plan the best treatment.

PURPOSE: This clinical trial is studying of quality of life and symptom management in patients with bladder cancer.

OBJECTIVES:

Primary

* To identify aspects of health-related quality of life (HRQOL) and symptom management in patients with non-invasive, low- or high-risk bladder cancer.
* To obtain feedback on data collection methods to enhance acceptability in these patients.

OUTLINE: Patients undergo a 10-minute screening in person or by phone to obtain demographic data and medical information (e.g., bladder cancer diagnosis and treatment history). Additional information is obtained from the clinical databases at the Baylor College of Medicine and the Michael E. DeBakey Veterans Affairs Medical Center. Patients who are eligible for the study are added to a waiting list for 1 of 4 focus groups based on disease status (high-risk or low-risk non-invasive bladder cancer) and gender. Patients participate in a 1.5- to 2-hour focus group discussion about the impact of bladder cancer on their quality of life and relationships. Patients receive information about community and Internet-based resources at the end of each group session.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of bladder cancer within the past 4 years

  * Non-invasive disease
  * Low- or high-risk disease
* Recruited from patients at the Baylor College of Medicine Scott Department of Urology clinics, the Michael E. DeBakey Veteran Affairs Medical Center, and the Urology Clinic at MD Anderson Cancer Center OR from participants at a community event

PATIENT CHARACTERISTICS:

* Not pregnant
* Able to read, speak, and understand English

PRIOR CONCURRENT THERAPY:

* Not specified
Use of Penthrox in Extra-hospital Traumatology

In pre-hospital settings, the administration of analgesics is often delayed because of difficult patient access (incarceration), difficulty finding a venous pathway or patient refusal.

An optimization of the management of pain in urgency is therefore still necessary.

A side from nitrousoxide of which usage remains restrictive, methoxyflurane (Penthrox®) is the only volatile analgesic currently available for pre-hospital use.

The purpose of this study is to answer the question: Does the use of the inhaled route with Penthrox add value to the treatment of acute traumatic pain in the pre-hospital stage?

In pre-hospital settings, the administration of analgesics is often delayed because of difficult patient access (incarceration), difficulty finding a venous pathway or patient refusal.

An optimization of the management of pain in urgency is therefore still necessary.

A side from nitrousoxide of which usage remains restrictive, methoxyflurane (Penthrox®) is the only volatile analgesic currently available for pre-hospital use.

Methoxyflurane (Penthrox®) is a single-use inhalation non-opioid analgesic for the management of moderate to severe traumatic pain. This treatment has been used in New Zealand and Canada for over 20 years for the management of acute pain in adults and children. It was granted marketing authorization in Europe in 2016 and has been marketed in France since 2017.

The purpose of this study is:

* To study the efficacy and safety of Penthrox, administrated at the beginning of the management of the traumatized adult patient.
* Assess the comfort of patients and caregivers
* To answer the question: Does the use of the inhaled route with Penthrox add value to the treatment of acute traumatic pain in the pre-hospital stage?

Eligibility Criteria:
Inclusion Criteria:

* Conscious Patient
* Age ≥ 18 years
* Acute pain only of traumatic origin
* Pain \> 4 on a visual numerical scale (VNS)
* Stable hemodynamic conditions (PA\> 90/60)

Non Inclusion Criteria:

* Pregnant or nursing woman
* Patient who has already received analgesics
* Patient benefiting from an intravenous approach for analgesia
* Known renal or hepatic disease
* Hypersensitivity to fluorinated anesthetics or history of malignant hyperthermia of the patient or family.
* Respiratory distress
* Patient who objected to the processing of his data

Exclusion Criteria:

* Intravenous injection for analgesia
Bismuth-containing Quadruple Therapy for Helicobacter Pylori Eradication

The researchers collect treatment-naive H.pylori-positive patients from the outpatient clinic. The subjects were randomized to receive a 10-day or 14-day course of quadruple eradication therapy. 6-8 weeks after treatment, the subjects will re-take the 13C-urea breath test. Calculate the eradication rates, adverse reaction rates, patient compliance and cost-effectiveness index of each group.

The researchers collect treatment-naive H.pylori-positive patients from the outpatient clinic. If the subject meets the selection criteria but not the exclusion criteria, and signs an informed consent form, the researchers randomized the subjects in groups: subjects received a 10-day or 14-day course of bismuth-containing quadruple eradication therapy. The medication of groups are as follows. 6-8 weeks after the eradication treatment, the subjects will review the 13C-urea breath test, and the researcher records the results.

After all subjects were tested, the eradication rates, adverse reaction rates, patient compliance and cost-effectiveness index of each group were calculated.

According to the course of treatment, it is randomized into a 10-day treatment group and a 14-day treatment group. The two groups of bismuth quadruple regimens are the same, as follows:

Option 1: Amoxicillin + Clarithromycin + Bismuth + Vonoprazan fumarate Option 2: Amoxicillin + Tetracycline + Bismuth + Vonoprazan fumarate Option 3: Amoxicillin + Metronidazole + Bismuth + Vonoprazan fumarate Three options are selected according to the hospital's situation.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-65.
* Patients with H.pylori infection (Positive for any of the following: H.pylori culture, histopathology test, rapid urease test, 13C/14C-urea breath test, stool H.pylori antigen test).
* Patients who have never received H. pylori eradication treatment.

Exclusion Criteria:

* Patients with serious underlying diseases, such as liver insufficiency (Aspartate aminotransferase or alanine aminotransferase greater than 3 times the normal value), renal insufficiency (Cr≥2.0mg/dL or glomerular filtration rate \<50 ml/min), immunosuppression, malignant tumors, Coronary heart disease or coronary artery stenosis ≥75%.
* Patients who are pregnant or lactating or unwilling to take contraceptive measures during the trial.
* Patients with active gastrointestinal bleeding.
* Patients with a history of upper gastrointestinal surgery.
* Patients allergic to treatment drugs.
* Patients with medication history of bismuth agents, antibiotics, proton pump inhibitor and other drugs within 4 weeks
* Patients with other behaviors that may increase the risk of illness, such as alcohol and drug abuse
* Patients whose re-check 13C/14C-urea breath test is negative before the start of the test.
* Patients who are unwilling or incapable to provide informed consents.
Cut-out of the Cervical Screw on Pertrochanteric Fractures

Pertrochanteric fractures are a highly relevant topic not only because of the high frequency or age of the population concerned, but also because of comorbidity (osteoporosis, malnutrition, decreased physical activity, decreased visual acuity, neurological deficits, asthenia, disorders of the equilibrium and impaired reflexes) and the mortality associated with this type of fractures.

The cut-out of the cervical screw is a mechanical complication common to different means of osteosynthesis of pertrochanteric fractures, this complication significantly increases the morbidity.

From January 2013 to May 2019, out of a total of 340 patients having had surgery for pertrochanteric fracture, 12 cases of cervical screw cut-out were recorded within the Brugmann University Hospital. The average follow-up after surgery was 18 months.

This study analyses different parameters and their link with cervical screw cut-outs, and compares the results with the ones published in the scientific literature.


Eligibility Criteria:
Inclusion Criteria:

All patients admitted for a pertrochanteric and subtrochanteric fracture of the femur treated by cerebrospinal nailing with all the methods of fixation of the head (blade or screw) and who evolved to a cut-out of the cervical screw.

Exclusion Criteria:

* Fractures treated by open osteosynthesis
* Fractures operated with good radiological outcome
* Incomplete or non useable medical files