cyrilzakka/clinical-trials huggingface dataset:
Very Long Term Results After Laparoscopic Retrocolic Antegastric Gastric Bypass

The main aim of this study is to analyze and report the very long-term outcomes after primary laparoscopic proximal Roux-en-Y gastric bypass surgery for clinically severe obesity.

There is lack of very-long term outcomes after bariatric surgery; A few series have been reported. However, most of them analyze medium-term outcomes. For RYGB, there are just two retrospective cohort studies reporting very long-term outcomes. Both studies have an open approach and a proximal Roux-en-Y configuration with different pouch orientation and size. MacLean´s series, with a better follow-up rate (83.4%), had a 67.6%EWL at a mean of 11.4 years; Failure rates were 20 and 35% for the morbidly obese and super obese, respectively. We will analyze our own series with a laparoscopic approach, vertically, lesser-curve base \< 10-15ml pouch and proximal Roux limb. The main end-points for our study are 1) Morbidity including status of specific biochemical markers \& Mortality, 2) Weight loss expressed as BMI or %EWL, 3) Trends in major comorbidities and 4) Assessment of Quality of Life.

Eligibility Criteria:
Inclusion Criteria:

* patients who met NIH criteria for recommendation of a bariatric procedure with a combination of the following characteristics

  * status post primary laparoscopic proximal RYGB surgery with or without subsequent open or laparoscopic revisions or re-operations
  * follow up \> 10.0 years (Very long term outcome)

Exclusion Criteria:

* patients who had a previous gastric or bariatric procedure
* patients who underwent primary laparoscopic RYGB somewhere else by other surgical group
* missing records and/or unreachable patients with scant information for analysis
Evaluation of OCT Measurements

The purpose of the study is to repeatability, reproducibility and agreement of eye measurements in retina and glaucoma patients.

The purpose of the study is to repeatability, reproducibility and agreement of eye measurements in retina and glaucoma patients using OCT technology. There will be a series of measurements acquired from one eye on at least 2 different OCT devices. All testing will be completed in one visit.

Eligibility Criteria:
Inclusion Criteria:

Inclusion Criterea:

* At least 18 years of age
* Able and willing to provide consent
* Willing to complete the required examinations and visits
* Best corrected visual acuity equal or better than 20/100
* Retina subject must have clinical diagnosis of retinal pathology
* Glaucoma subjects must have clinical diagnosis of glaucoma

Exclusion Criteria:

* Unable to complete the required examinations and visits
* Poor OCT image quality as a result of media opacity, extreme refractive error or pathologies in the anterior segment
* Confounding pathology requiring surgical treatment or medical intervention
The BD Odon DeviceTM for Assisted Vaginal Birth: a Feasibility Study to Investigate Safety and Efficacy

Besancon ASSIST study will investigate if the BD Odon DeviceTM is safe, effective and acceptable to women and maternity staff for assisted vaginal birth.


Eligibility Criteria:
Inclusion Criteria:

* The woman is ≥18 years of age
* The woman has a singleton pregnancy
* The pregnancy is ≥28+0 weeks' gestation
* There is a negative antenatal screen for HIV and Hepatitis B

Exclusion Criteria:

* The woman does not fulfil all of the inclusion criteria listed
* There is a diagnosis of a fetal skull abnormality precluding AVB (i.e. macrocephaly)
* There is a known osteogenesis imperfecta affected pregnancy
* There is suspicion of a fetal bleeding disorder (von Willebrand's disease, AITP, haemophilia)
* There is an intrauterine fetal death in the current pregnancy
* The woman is sensitive to latex
* The woman is currently serving a prison sentence
* The woman lacks capacity to consent
* The woman has a lack of ability to read or understand French as this would preclude successful completion of questionnaires
* The woman has received intramuscular or intravenous opiates (i.e. pethidine or morphine) within the past 6 hours
* The woman is in established labour (≥ 4cm cervical dilatation) without regional analgesia in place
Evaluating the Relationship Between Fatty Acids and Heart Disease

Cardiovascular disease (CVD) affects millions of people in the United States; each year, more people die from CVD than from any other disease. Individuals with low levels of n-3 fatty acids and high levels of trans-fatty acids may have an increased risk of developing CVD. This study will evaluate the link between fatty acids and the presence of CVD in older adults.

CVD includes diseases that affect the heart and blood vessels, including congestive heart failure (CHF), atrial fibrillation (AF), and stroke. CVD may be associated with low levels of n-3 fatty acids and high levels of trans-fatty acids, but more research is needed to determine the role of various fatty acids in the development of CVD. Results from prior studies on this topic have not always been reliable because data from self-reported dietary questionnaires on fatty acid intake have sometimes been inaccurate. A more effective way to measure levels of fatty acids is to analyze blood samples. This study will use blood samples of participants in the Cardiovascular Health Study, a study that examined CVD risk factors in older adults, to determine the link between various fatty acids and the incidence of CHF, AF, and stroke. The results from this study may help researchers identify the dietary factors that influence the development of CVD in older adults.

This study will examine previously collected data from participants in the Cardiovascular Health Study. There will be no study visits specifically for this study. Plasma samples obtained from participants will be analyzed for the presence of n-3 fatty acids and trans-fatty acids. The study will also determine the incidence of CHF, AF, and stroke and the way in which fatty acids are related to hemodynamics, heart structure and function, electrophysiology, insulin sensitivity, inflammation, endothelial function, and obesity.

Eligibility Criteria:
Inclusion Criteria:

* Participated in the Cardiovascular Health Study
RANKL Inhibition and Breast Tissue Biomarkers

A robust knowledge of how to reduce breast density could play a key role in breast cancer prevention in premenopausal women, but viable preventative targets to reduce breast density-associated breast cancer risk are yet to be developed. The investigators propose to investigate the effect of RANKL inhibition with denosumab on breast tissue markers in high-risk premenopausal women with dense breasts. Study findings could provide robust evidence to move forward with a clinical trial targeting RANKL inhibition in premenopausal breast cancer prevention.


Eligibility Criteria:
Inclusion Criteria:

* Female.
* Premenopausal.
* At least 35 years of age.
* Dense breasts on routine mammogram.
* Willing to take calcium (1,200mg) and vitamin D (800 IU) daily.
* At increased risk for breast cancer using any of the following:

  * Positive family history of breast cancer
  * Breast cancer risk prediction models
* Able and willing to return for repeat biopsy.
* Able to understand and willing to sign an IRB-approved written informed consent document.

Exclusion Criteria:

* Current use of tamoxifen, aromatase inhibitors, or bisphosphonates.
* Concurrently participating in another cancer chemoprevention trial (unless no longer receiving the intervention).
* Pregnant or lactating.
* Recent tooth extraction or dental procedure.
* Unhealed and/or planned dental/oral surgery.
* History of osteonecrosis/osteomyelitis of the jaw.
* History of osteoporosis or severe osteopenia.
* Unable/unwilling to return for repeat biopsy.
Miltefosine (Long Course) for Bolivian Mucosal Leishmaniasis

Miltefosine (longer course) will be used to try to improve the cure rate of mucosal leishmaniasis

Miltefosine (42 days) will be used to try to improve upon the cure rate with 28 days of drug for bolivian mucosal leishmaniasisi

Eligibility Criteria:
Inclusion Criteria:

* Mucosal leishmaniasis

Exclusion Criteria:

* No comcomitant disease as judged by laboratory and clinical parameters
Comparison of Aerosol Inhalation and Intravenous Glucocorticoid in the Treatment of Severe AECOPD

Comparison of aerosol inhalation and intravenous glucocorticoid in the treatment of severe AECOPD-------Multicenter, prospective, randomized, controlled clinical study

This study aims to compare the efficacy and comprehensive benefits of aerosol inhalation and intravenous injection of glucocorticoids in severe AECOPD patients.

Eligibility Criteria:
Inclusion Criteria:

(1) Patients with AECOPD requiring hospitalization or emergency treatment (COPD acute attacks combined with respiratory failure were eligible). (2) 18 years of age ≤80 years of age (3) Patients and their families are willing to participate in clinical research and sign informed consent.

Exclusion Criteria:

1. Combined with tuberculosis.
2. Combined bronchiectasis.
3. complicated with definite infectious diseases.
4. PCT≥0.5ng/ml or CRP≥30mg/L.
5. Serious injury combined with other organ functions
6. Contraindications to other glucocorticoid use.
7. Concomitant bronchial asthma or positive bronchodilation test
Effect of Intravaginal Prasterone on Symptoms of Genitourinary Syndrome of Menopause (GSM) in Women in Menopause With Previous Breast Cancer

The goal of this interventional study is to evaluate the effect of Intravaginal Prasterone for the treatment of moderate to severe symptoms of genitourinary syndrome (GSM) due to natural, surgical or treatment-induced menopause and the effect on the quality of life, including sexual function and mood well-being, in women with Breast Cancer. A sample size of 95 patients will be needed to show that the proportion of women showing symptom improvement is greater than 50%. Subjects will be followed up at four weeks and twelve weeks of treatment. One and three-month outcomes will be provided after the end of treatment. Comparison between menopausal women with previous breast cancer that have finished hormonal therapy or with ER negative breast cancer and women currently under endocrine therapy with AIs will be performed.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed breast cancer, completely excised
* Natural or iatrogenic menopausal status
* No evidence of distant metastasis
* Self-identified moderate to severe symptoms of genitourinary syndrome
* Normal kidney and liver function
* Written Informed Consent signed and dated by patient
* Negative Papanicolau (Pap) Smear Cytology Test within 1 year prior to enrollment

Exclusion Criteria:

* Vaginal or uterine bleeding of unknown origin
* Current diagnosis of any non-breast malignancy
* Metastatic disease
* Currently on chemiotherapy
* Currently on treatment with tamoxifen
* Mentally incompetent or evidence of active substance or alcohol abuse
* Endometrial hyperplasia
* Pregnancy or lactation
* Currently use of other vaginal therapy for the same purpose (if present, they have to be stopped 15 days before baseline visit)
* Clinically significant metabolic or endocrine disease not controlled by medication
Active Surveillance Post-Approval Atudy of the Stelkast Surpass Acetabular System

The active surveillance post-approval study of the Stelkast Surpass Acetabular System is a retrospective, multi-center, single-arm study intended to collect data on the survivorship and long-term safety and effectiveness of the device.

This active surveillance study is intended to evaluate the survivorship and long-term safety and effectiveness of the Stelkast Surpass Acetabular System. Neither the patient nor the surgeon are blinded to treatment. The study will compare the Surpass' survivorship to the survivorship observed in a historical control group established by a meta-analysis. The evaluation will be conducted for a period of ten years. These evaluations will be recorded through onsite visits and/or mailings sent to physicians requesting deidentified patient-level data for subjects implanted with the Surpass system.

Eligibility Criteria:
Inclusion Criteria:

* Primary hip arthroplasty
* Skeletal maturity
* Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, congenital hip dysplasia, and traumatic arthritis

Exclusion Criteria:

* The Stelkast Surpass Acetabular System is contraindicated in patients with the following conditions: Overt or latent infection in or around the hip joint, insufficient bone stock to allow appropriate insertion and fixation of the prosthesis, insufficient soft tissue integrity to provide adequate stability, muscle laxity or inadequate soft tissue for proper function and healing, mental or neuromuscular disorders that do not allow control of the affected joint, revision hip arthroplasty, inflammatory hip joint disease, and neuropathic hip joint disease.
Usability and Acceptance of a New Robotic Exoskeleton for Shoulder Rehabilitation

The purpose of this pilot study is to validate the safety, reliability and usability of FLOAT medical device, a prototypal robotic system for the rehabilitation of the shoulder, designed and developed in the Rehab Technologies IIT-INAIL Lab to fulfil the needs orthopaedic conditions. The acceptance from patients and therapists will be assessed after a single session of robotic therapy in a sample of injured workers suffering from post-traumatic or post-surgical shoulder disorders.

This study aims to:

1. Test the safety and reliability of the FLOAT device for delivering post-acute motor and functional rehabilitation of patients with orthopaedic shoulder dysfunction.
2. Assess the three different modalities of utilization of the exoskeleton (Passive Mode, Learn\&Repeat Mode, Transparency Mode).
3. Evaluate the usability of the device in terms of comfort, adaptability to different patients' anthropometrics, general functioning and overall satisfaction.

Six injured workers with shoulder post-traumatic and post-operative dysfunction will be enrolled in a single testing session at the INAIL Rehabilitation Center in Volterra. Pilot testing of FLOAT device will focus mainly on the feasibility of implementing the multiple operating modes of the new device, recording patients and therapist's feedback. The session will last about 3 hours and all exercises will be administered by a trained physical therapist supported by a member of the engineering team.

For Aim 1, Safety and Reliability of the device will be evaluated in terms of the number of adverse events and malfunctions occurring during the study session.

For Aim 2, each modality will be assessed by means of the Numeric Pain Rating Scale (NPRS), The Borg CR10 Scale Perceived Exertion (only for the Transparent mode) and ad-hoc clinician-generated questionnaires for both patients and therapists.

For aim 3, patient and therapist's general evaluation about usability will be detected through a final ad-hoc questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Height between 160 and 185 cm;
* Distance between the shoulder joint center and the sagittal plane between 156 and 197 mm;
* Shoulder joint center to wall distance between 82 and 142 mm
* Maximum shoulter radius: 120 mm
* Distance between the shoulder joint center and the elbow joint center between 250 and 303 mm
* Time from acute event ≥ 60 days
* Right shoulder joint disfunction after orthopaedic injury or surgery as a result of work accidents
* Post-immobilization phase
* At least 80° shoulder passive flexion and 45° shoulder passive abduction
* Pain intensity on movement \< 6 NRS;

Exclusion Criteria:

* Glenohumeral joint instability
* Shoulder Prosthetic implants
* Upper arm sensorimotor deficits
* Chronic inflammatory disorder involving upper arm joints
* Pseudoarthrosis of the proximal humerus fractures
* Spinal fractures within the last 3 months
* Open skin at the level of the patient-device interface
* Current or prior history of malignancy
* Pregnancy or breast feeding
Collection and Measurement of Biomarkers in Prostate Cancer Radiotherapy Patients

The purpose of this research study is to learn about: 1) How standard radiation treatment to prostate (primary radiotherapy) or the pelvis after prostatectomy (postoperative radiotherapy) may cause changes in MRI and PET imaging traits that might be used in the future to predict response. 2) Comparison of such MRI and PET imaging traits with the number of circulating tumor cells (CTCs) present in the blood prior to treatment and the changes in these counts after treatment. 3) How MRI and PET imaging characteristics and changes are related to the expression of genes in the cancer tissue obtained before treatment from prostate biopsy or a prior prostatectomy before treatment. 4) How the response of prostate cancer treatment relates to the imaging and CTC changes.


Eligibility Criteria:
Inclusion Criteria:

1. Pathologic confirmation of prostate cancer.
2. Any T-stage.
3. By imaging or clinical criteria, any patient with disease staging of N0/N1 and M0/M1.

   * Patients with metastatic disease are encouraged to participate.
4. Any Gleason Score will be eligible.
5. Androgen deprivation therapy (ADT) is at the discretion of the treating physician, but must be declared as none, short-term, long-term, or extended prior to enrollment. The length is calculated from the LHRH (agonist injection). If ADT is planned (based on treating physician preference), the following restrictions apply:

   * Short term ADT is defined as ≤ 7 months;
   * Long term ADT is defined as \> 7 months and ≤ 36 months;
   * Extended ADT is defined as \>36 months (e.g., M1 patients).
6. Prostate-specific antigen (PSA) ≤100 ng/mL within (+/-) 4 months of signing of consent. If PSA was above 100 and drops to \<100 with antibiotics, this is acceptable for enrollment.
7. No previous pelvic radiotherapy.
8. The ability to understand and the willingness to sign a written informed consent document
9. Zubrod performance status ≤ 2 (Karnofsky or ECOG performance status may be used to estimate Zubrod):
10. Age ≥ 30 at signing of consent.
11. Subjects must be planned to receive radiation therapy or to undergo prostatectomy.
12. Subjects treated primarily with RT are recommended to have had an MUFgBx prior to radiation treatment.
Clinical Efficacy of Conventional and Diode Laser-Assisted Frenectomy in Patients With Abnormal Different Frenum Insertions: A Retrospective Study

Aim: The aim of this retrospective study was to assess the frenum attachment recurrence and evaluate clinical parameters after conventional and diode laser-assisted frenectomy in patients with different abnormal frenum insertions.

Methods: Data records of 429 patients treated with maxillary labial frenectomy between January 1, 2016 and January 1, 2018 were screened. Records of 70 patients meeting the inclusion criteria were evaluated. Data were analyzed in terms of gender, age, category of frenum, presence of diastema, operation technique, type of periodontal disease. The distance between frenum attachment and mucogingival junction (FMGJ), plaque index (PI), gingival index (GI) and probing depth were assessed.


Eligibility Criteria:
Inclusion Criteria:

(a) systemically healthy, (b) nonsmoker, (c) aged between 18 and 65 years, (d) received initial periodontal treatment before frenectomy, (e) presence of central and lateral incisors and canines at maxilla, (f) not received any kind of periodontal surgery, prosthodontic and restorative treatment which may affect the anatomy of the relevant region.

Exclusion Criteria:

Subjects with incomplete documentation and without at least 6-week follow-up observation were excluded.
Guided Self-help for Common Mental Disorders

Common mental disorders (CMDs) like depression and anxiety account for a large proportion of disability worldwide. Access to effective treatments like cognitive-behavioral therapy (CBT) is limited and has not reduced the public health burden of psychopathology. For patients with mild-moderate CMDs, lower-intensity treatments like guided self-help CBT (GSH-CBT) are effective and more scalable (e.g., via the internet). The advent of social media has opened avenues for dissemination of GSH-CBTs and allows for passive sensing of mood, thinking, behavior, and social networks. We propose to leverage a social media platform used by over a fifth of the United States (Twitter) as a recruitment tool to virtually screen over 150 individuals, recruit N=60 to a 5-week course of GSH-CBT, and extract social media data from individuals engaged in GSH-CBT. Sociodemographic and social media data will be used to predict engagement, outcomes, and processes in GSH-CBT.


Eligibility Criteria:
Inclusion Criteria:

* At least mild distress: K6 score ≥ 6
* Having reasonably regular access to the internet or a telephone

Exclusion Criteria:

- Suicidality: Patient Health Questionnaire-9 (PHQ9) item 9 ("thoughts that you would be better off dead, or of hurting yourself ") ≥ 2 ("more than half the days")
The Relationship Between Emotional Regulation Strategies And Cognitive Behavioral Treatment Effectiveness In Childhood Anxiety Disorders: A Longitudinal Prospective Study

The current study will focus on two phases of anxiety process: Generating Anxiety (reported, direct and physiological) and Emotional Regulation Strategies (Reappraisal, Mindfulness, Expressive Suppression and Rumination). The claim is that better understanding of these phases in relation to CBT treatment will lead to better understanding of remission in anxiety and to better treatments in the future. Objectives: To understand the relations between the four strategies of emotional regulation to anxiety disorder hence to understand the relation between these strategies to treatment effectiveness of children with anxiety disorder. Methods: In phase one, clinically anxious adolescence before treatment (N=40) and healthy controls (N=40) will be compared. Anxious adolescence are expected to have significantly higher levels of physical arousal and will use spontaneously more expressive suppression and rumination and less reappraisal and mindfulness then the healthy controls. In phase two, clinically anxious adolescence (N=40) before and after 8-12 weeks of CBT treatment will be compared. More specifically remitted patients will be compared with partially remitted patients. Remitted patients are expected to show better improvement in the physical arousal, then partially remitted. More, Decrease in levels of anxiety will be mediated by the four emotional regulation strategies, and the efficiency of using the Reappraisal will be higher.


Eligibility Criteria:
Inclusion Criteria:

* anxious group: Clinical diagnosis of one or more of the following diagnoses: Generalized Anxiety Disorder, Social Anxiety, Separation Anxiety, panic disorder.
* non anxious group: do not meet the criteria for anxiety disorders as well as for any other mental disorder

Exclusion Criteria:

* anxious group: not treated during the study in any other treatment for anxiety disorders.Clinical diagnosis of one or more of the following diagnoses: psychosis, dyslexia, mental retardation, PTSD.
Extension Trial of Ublituximab and TGR-1202 in Combination or as Single Agents in Subjects Currently Receiving Treatment on Ublituximab and/or TGR-1202 Trials

This is an open label compassionate use trial of Ublituximab and TGR-1202 in combination or as single agents in patients currently receiving treatment on Ublituximab and/or TGR-1202 trials with B-cell Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must be currently receiving treatment with ublituximab and/or TGR-1202 on a previously approved protocol.
* Subjects must have completed at least 6 cycles of therapy on their current protocol.

Exclusion Criteria:

* Subject progressed while receiving therapy with ublituximab and/or TGR-1202 while participating in their immediate previous trial.