cyrilzakka/clinical-trials huggingface dataset:
A Randomized Controlled Trial of Mental Health Peer-Led Education

This randomized controlled trial tests the efficacy of a mental health peer-led educational intervention called BRIDGES (Building Recovery of Individual Dreams and Goals through Education and Support). The BRIDGES program is a 10-week, manualized education course designed to provide basic information about the etiology and treatment of mental illness, self-help skills, and recovery principles in order to empower participants to return to valued social roles within their communities. BRIDGES is a peer-led program and all instructors are adults with mental illnesses. For study purposes, the 10-week course was modified to 8-weeks, meeting 2 1/2 hours once a week.

Hypothesis #1: Compared to wait-list controls, intervention participants will report increased feelings of psychological empowerment.

Hypothesis #2: Compared to wait-list controls, intervention participants will report increased feelings of hopefulness.

Hypothesis #3: Compared to wait-list controls, intervention participants will report enhanced coping ability.

Hypothesis #4: Compared to wait-list controls, intervention participants will report enhanced recovery.

Hypothesis #5: Compared to wait-list controls, intervention participants will report greater ability to advocate for themselves with health care providers.

Hypothesis #6: Compared to wait-list controls, those in the BRIDGES education course will report increased knowledge of the causes and treatment of mental illness and recovery principles.

Eligibility criteria included having a diagnosis of serious mental illness and experiencing severe functional impairment in one or more life roles. All study participants completed telephone interviews at three points in time: study entry (pre-intervention); 8-weeks later (immediate post-intervention); and 6-months after intervention (approximately 8 months after study entry). Blinded interviewers administered valid and reliable outcome assessments that measured changes in subjects' knowledge about mental illness; emotional well-being; empowerment; hopefulness; self-advocacy; and recovery. All study participants were compensated for their time at each interview. All BRIDGES instructors were people in recovery from serious mental illnesses who were certified and experienced BRIDGES teachers. Fidelity to the BRIDGES curriculum was assessed on an ongoing basis throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of mental illness
* Disability due to mental illness
* Age 18 years or older
* Willingness to receive the intervention

Exclusion Criteria:

* Inability to understand spoken English
The Effects of Increased Fiber Diet Consumption on Outcomes of Subjects With Visceral Obesity

The investigators propose to undertake a controlled dietary intervention study in UAE subjects with visceral obesity to examine the feasibility of a diet rich in fruits, vegetables and/or whole-grain fiber in the UAE population. The research will also investigate the longer-term influence of increased fruits, vegetables and fiber consumption on health and its capacity to sustain lifestyle change.

The United Arab Emirates (UAE) has one of the highest prevalence of obesity related diabetes mellitus in the World \[3\]. Visceral (abdominal) obesity is particularly common and more closely related to morbidity in the UAE. The investigators propose to undertake a controlled dietary intervention study in UAE subjects with visceral obesity, the aims of which are: (i) To examine the feasibility of a diet rich in fruits, vegetables and/or whole-grain fiber in the UAE population (ii) To examine the effects of increased fruits, vegetables and/or whole-grain fiber consumption on cardio metabolic risk factors (iii) To investigate the longer-term influence of increased fruits, vegetables and fiber consumption on health and its capacity to sustain lifestyle change. The proposed study will provide the scientific rationale and the methodology for improving the diet and promote healthy eating in the UAE population.

Eligibility Criteria:
Inclusion Criteria:

* Individuals with visceral obesity (WC=\>88 cm for women and =\>92 cm for men).

Exclusion Criteria:

* Individuals with severe chronic clinical or psychiatric disease, 2) Participating in other intervention trials, have a special diet or taking supplements. Consent All volunteers will be required to provide informed written consent
A Cognitive-Behavioral Intervention for Depression and Anxiety in COPD

The literature and our preliminary studies found that in COPD patients, psychosocial factors affect quality of life (QOL) and functioning more than would be expected given the severity of their disease. To improve QOL and functioning in the approximately 50% of COPD patients with significant anxiety and/or depressive symptoms, interventions are needed. Much research documents the utility of cognitive behavioral therapy (CBT) in treating depression and anxiety, showing it to have promise as a self-management intervention to improve QOL in COPD patients.

Background:

The literature and our preliminary studies found that in COPD patients, psychosocial factors affect quality of life (QOL) and functioning more than would be expected given the severity of their disease. To improve QOL and functioning in the approximately 50% of COPD patients with significant anxiety and/or depressive symptoms, interventions are needed. Much research documents the utility of cognitive behavioral therapy (CBT) in treating depression and anxiety, showing it to have promise as a self-management intervention to improve QOL in COPD patients.

Objectives:

Objectives were to compare CBT for anxiety and depression with COPD education for COPD patients with moderate-to-severe anxiety and/or depressive symptoms.

Methods:

Veterans were recruited from VAMC clinics and through press releases. Two hundred and thirty-eight COPD patients with comorbid anxiety and/or depressive symptoms were randomized to either 8 weeks of CBT/usual care or 8 weeks of COPD Education/usual care. We hypothesized that COPD patients receiving CBT/usual care would improve more than COPD patients receiving COPD Education/usual care. Improvement was defined as increased disease-specific QOL, generic QOL, and 6-minute walk distance; and decreased depression, anxiety, and health service use. Outcomes were examined pre-, mid- and post-treatment and at 4, 8 and 12 months.

Status:

The study was scheduled to officially end December 31, 2005, but was granted a no-cost extension by HSR\&D to complete data analyses and prepare final papers. The extension was granted through June 30, 2006. As of the date of this final report, the study is complete.

Eligibility Criteria:
Inclusion Criteria:

Moderate depression or anxiety, COPD

Exclusion Criteria:
Moderately Hypofractionated Conformal Radiation Combined With S-1 for Esophageal Squamous Cell Carcinoma

This Phase II randomized study is to determine the efficacy and toxicities of moderately hypofractionated conformal radiation combined With S-1 for esophageal squamous cell carcinoma.

This Phase II randomized study is to determine the efficacy and toxicities of moderately hypofractionated conformal radiation combined With S-1 for esophageal squamous cell carcinoma.

All patients will receive two cycles of S-1 (40mg/㎡, BID, po) on D1-14, D22-35, combined with thoracic radiotherapy of 60 Gy/24 fractions for GTV and 40 Gy/16 fractions for CTV. The primary end point is progression-free survival, which is the time that passes from the first day of radiotherapy to the date on which disease progresses. Progression-free survival will be calculated and compared using the Kaplan-Meier method.Toxicities will be graded according to CTCAE v. 4.0.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed esophageal squamous cell carcinoma
* Inoperable stage II-IVa (UICC 2002; sixth edition), confirmed by contrast enhanced computed tomography,endoscopic ultrasonography, barium esophagram, emission computed tomography and/or positron emission tomography/computed tomography.
* Eastern Cooperative Oncology Group (ECOG) performance status 1-2
* Estimated life expectancy of at least 12 weeks
* Charlson comorbidity index.4
* Adequate bone marrow function: white blood cells grade 0 or 1,absolute neutrophils grade 0 or 1, platelets grade 0, haemoglobin grade 0 or 1
* Adequate renal function: creatinine grade 0 or 1
* Adequate liver function: serum bilirubin grade 0 or 1, alanine aminotransferase and aspartate aminotransferase \<2 times of the upper normal limit
* Weight loss.15% during 6 months prior to diagnosis
* Forced expiratory volume second.1L

Exclusion Criteria:

* Prior history of malignancy, except for nonmelanoma skin carcinoma or cervical carcinoma in situ
* Previous anti-tumor therapy, including surgery, chemotherapy or radiotherapy
* Contraindication for chemotherapy or radiotherapy
* Malignant pleural or pericardial effusion
* Women in pregnancy or lactation period
* Women who has the probability of pregnancy without contraception
* Weight loss≥15% during 3 months prior to diagnosis
* In other clinical trials within 30 days
* Addicted in drugs or alcohol, AIDS patients
* Uncontrollable seizure or psychotic patients without self-control ability
* Severe allergy or idiosyncrasy
* Not suitable for this study judged by researchers
Retrospective Study of Surgical Induced Abortions Between 14 and 16 Weeks of Amenorrhea At Croix Rousse University Hospital in Lyon

In France, induced abortions can be carried out by two different methods: the medicinal one, which involves taking medications to expel the pregnancy (MIFEPRISTONE and then MISOPROSTOL), and the instrumental one, which involves aspiration in the operating room.

According to the high authority of health, before 9 weeks of amenorrhea, both methods are possible if there is no contraindication to one of them. After 9 weeks of amenorrhea, only the instrumental method is authorized.

Until March 2022, the maximal deadline to abort was 14 weeks of amenorrhea. On March 2nd 2022, a change in the law extended this time limit from 14 to 16 weeks of amenorrhea. Only one study was carried out following this change in France to assess the complication rate of late abortions (between 14 and 16 weeks of amenorrhea (AW)). This study was carried out at Trousseau Hospital in Paris, with a total of 46 patients. The results of this study were reassuring, with bleeding \> 500 mL for only one patient (2.2%, 95% CI \[0.0-6.4\]) and no complications such as perforation, postoperative infection or revision surgery, or need for transfusion.

However, this paper is the only French study which evaluated the operative risks of late abortion since the change in the law, and its power is small. There is a need to assess the operative risks of late abortion on a larger cohort.

That's why the investigators had the idea to conduct a study looking at all instrumental abortions performed in Croix Rousse Hospital in Lyon between March 2022 and March 2023, representing around 700 procedures. The aim of the study is to compare the complication rates of instrumental abortions between 14 and 16 weeks of amenorrhea versus those carried out before 14 weeks.


Eligibility Criteria:
Eligibility Criteria \*

* Inclusion Criteria \* :

  * Surgical induced abortion
  * At Croix Rousse hospital, Lyon
  * Between March 2022 and March 2023
* Exclusion Criteria \* :

  * Minor patients
Deep Brain Stimulation in Patients With LUTS

Deep brain stimulation (DBS) is a neurosurgical procedure using a device that improves motor symptoms of specific neurological and movement disorders such as Parkinson's disease or Essential Tremor. As part of the patient's care, the DBS is implanted when symptoms cannot be satisfactorily controlled with medications or conventional therapies. Lower urinary tract symptoms are common in patients who have underlying neurological or movement disorders and control over lower urinary tract function is poorly understood. In this study investigators are evaluating the effects of DBS on lower urinary tract function.

Deep brain stimulation (DBS) is a neurosurgical procedure that improves motor symptoms of specific neurological and movement disorders such as Parkinson's disease or Essential Tremor. DBS is implanted when symptoms cannot be satisfactorily controlled with medications or conventional therapies. After insertion of deep electrodes, electrical stimulation will be delivered to modulate specific neurons in certain areas of the brain. Despite, the known motor effects for DBS, its nonmotor effects on other organs such as the urinary tract and bladder function remains unclear. Lower urinary tract symptoms such as frequency, urgency, urinary incontinence, or incomplete bladder emptying are common in patients who have underlying neurological or movement disorders. In addition, central neural control over lower urinary tract function is still poorly understand. In this trial investigators plan to evaluate the effects of Deep Brain Stimulators (DBS) on lower urinary tract function. This trial is designed to test the hypothesis that DBS improves objective and subjective symptoms of lower urinary tract function in specific patient populations. The investigators plan to test this hypothesis by using validated patient reported outcome questionnaires and urodynamic testing (both are part of routine care for neurogenic bladder) before and after DBS implantation. In addition, this trial will shed some light in understanding higher neural control of bladder and potentially identify target areas for future intervention.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are a candidate for Deep Brain Stimulation (DBS) as standard care for neurologic symptoms and have a moderate or greater urinary bother American Urological Association Symptom Score (AUASS≥8)

Exclusion Criteria:

* Pregnant, breastfeeding mothers and all individuals younger than 18 years of age will be excluded. Patients with history of urinary diversion or augmentation cystoplasty will also be excluded.
Study of [S,S]-Reboxetine in Patients With Postherpetic Neuralgia, Who Are Gabapentin Treatment Failures

The purpose of this study is to determine the effectiveness of \[S,S\]-Reboxetine in the treatment of chronic pain following a shingles infection in patients who are Gabapentin treatment failures.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have pain present for more than 3 months after the healing of shingles skin rash.
* Patients at screening must have a score \> or = 40 mm on the pain visual analogue scale.

Exclusion Criteria:

* Patients with poor renal function.
* Patients with other severe pain, that may impair the self-assessment of the pain due to shingles.
* Patients with abnormal electrocardiogram.
Cardiovascular Outcomes and HbA1c Among Patients With Type 2 Diabetes Newly Initiating GLP1RAs vs Basal Insulin

This study will compare hemoglobin a1c (HbA1c) and cardiovascular (CV) outcomes among patients with type 2 diabetes newly initiating a GLP1-receptor agonist or basal insulin.

The 2019 ADA-EASD clinical treatment guidelines recommend a GLP-1RA over basal insulin for patients with type 2 diabetes with suboptimal glycemic control despite metformin and a second-line glucose lowering agent. The basis of this recommendation is due to the side effect profiles of these two medications (i.e. reduced risk of hypoglycemia, some weight loss with GLP-1RA), convenience (once weekly injection) and the fact that the price of insulin has skyrocketed in recent years. Prior head-to-head randomized trials (EAGLE, LEAD 5) comparing select GLP-1RA and basal insulin have found mixed results. In EAGLE, adding either insulin glargine or liraglutide to patients with poorly controlled type 2 diabetes found no differences in the primary outcome (percentage of people reaching HbA1c \< 7%). In LEAD 5, liraglutide was associated with a slightly greater HbA1c reduction than glargine, however the dose of insulin was approximately 50% less than the dose used in EAGLE. The objective of this observational study is to describe the comparative effectiveness and safety of newly initiating a GLP1RA versus basal insulin in patients with type 2 diabetes using metformin and another oral glucose lowering medicine.

Eligibility Criteria:
Inclusion Criteria:

* Age\>=18 years
* at least 180 days of continuous enrollment prior to index date
* at least 1 Type 2 diabetes diagnosis code prior to index date
* (for cohort #1) at least 2 metformin dispensings prior to index date AND days supply overlap on cohort entry date (with 14 days of grace period before)

Exclusion Criteria:

* any type 1 diabetes diagnosis code prior to index date
* medullary thyroid carcinoma, multiple endocrine neoplasia type 2 (both black box warnings) prior to index date
* h/o pancreatitis
* h/o recurrent hypoglycemia (i.e. more than 1 hospitalization / emergency department encounter in primary diagnosis position for hypoglycemia)
* index injectable is a combination of GLP1-RA plus insulin
* index GLP1-RA is Saxenda (indicated for weight loss) or liraglutide at 3.0mg dose
* index insulin regimen includes both basal and prandial insulin, or premixed insulin
* Any prior GLP1-RA use (Applied washout for 180 days)
* Any prior insulin use; Sometimes insulin is transiently used at diagnosis (Applied washout for 180 days)
* Secondary diabetes
* Gestational diabetes
* Nursing home admission (because we don't have pharmacy claims)
* Age \<18 years
* Chronic kidney disease stage 4-6
* Advanced cancer
* End stage renal disease

For A1c cohort only:

-HbA1c \>12%
Autologous Cord Blood and Human Placental Derived Stem Cells in Neonates With Severe Hypoxic-Ischemic Encephalopathy

The purpose of this study is to investigate the safety and effectiveness of autologous human placental-derived stem cells (HPDSC) in combination with autologous cord blood in neonates with severe hypoxic-ischemic encephalopathy.

The primary aim of this study is to determine the safety, tolerability and feasibility of intravenous administration of autologous cord blood (CB) and autologous human placental derived stem cells (HPDSC) in neonates with severe hypoxic-ischemic encephalopathy (HIE). It is hypothesized that the administration of autologous CB and autologous HPDSC will be safe and well tolerated in neonates with severe HIE.

Additionally, postnatal neuro-developmental outcomes in neonates with HIE after autologous CB and HPDSC therapy will be measured; HIE injury to the neonate/infant brain post autologous CB and HPDSC therapy by imaging will be characterized; the pluripotent stem cell properties of CB and HPDSC will be characterized; serum levels of selected circulating cytokine and neurotrophic factors in neonates with HIE before and after autologous CB and HPDSC therapy will be compared and immune cell phenotype and function in neonates with HIE before and after autologous CB and HPDSC therapy will be compared.

Eligibility Criteria:
Inclusion Criteria:

* Gestational age ≥ 36 weeks
* Birth weight ≥ 1800 grams
* Postnatal age after birth of less than 6 hours
* Autologous cord blood and HPDSCs available for infusion
* Plus one or more of the following criteria: Apgar ≤ 5 at 10 minutes of postnatal age, or Continued need for resuscitation ≥10 min after birth, or Acidosis-cord blood pH or arterial blood pH within 60 minutes of birth ≤ 7.0 pH, or Base deficit ≥ minus 16mEq in cord blood and within 60 min of birth.
* Plus Moderate to Severe Altered State of Consciousness, by one or more of the following: Hypotonia, or Abnormal reflexes, or Absent/weak suck.

Exclusion Criteria:

* Major life-threatening or surgical anomalies
* Polycythemia (hematocrit \> 65%)
* Congenital infection based on antenatal diagnosis of TORCH infection
* Parental refusal for study
* Infant expected to live \< 24h, medical care is considered futile and no additional therapy will be offered by the attending neonatologist
Study Of Sunitinib In Combination With Folfox In Patients With Colorectal Cancer

To assess the safety and tolerability of sunitinib when administered in combination with modified FOLFOX6 in Japanese patients with metastatic colorectal cancer in the first-line treatment setting.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed adenocarcinoma of the colon or rectum with documented locally advanced or metastatic disease.
* Evidence of unidimensionally measurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST).
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Exclusion Criteria:

* Prior treatment with systemic therapy for locally advanced or metastatic colorectal cancer.
* Prior surgery or investigational agent within 4 weeks prior to study entry.
* Pregnancy or breastfeeding. All female patients of reproductive potential must have a negative pregnancy test (serum or urine) prior to the start of the study.
To Compare the Efficacy and Safety of INS068 and Insulin Glargine in Subjects With Type 2 Diabetes Mellitus Treated With Basal Insulin.

The study aims to evaluate the efficacy and safety of INS068 once daily (QD) in subjects with type 2 diabetes not adequately controlled with basal insulin compared to insulin Glargine QD for 26weeks.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed with type 2 diabetes≥ 6 months;
2. HbA1c 7.0% \~ 10.0% (Both inclusive) at screening;
3. Treated with Basal insulin ≥10U /day for at least 8 weeks prior to screening.

Exclusion Criteria:

1. Known or suspected allergy or intolerance to investigational medicinal products or related products.
2. Hospitalization for diabetic ketoacidosis or hyperglycemic hyperosmolar state within the previous 6 months.
3. Potentially unstable diabetic retinopathy or macular degeneration that requires treatment (e.g., laser, surgical, or injectable medications) within the previous 6 months.
4. Received premixed insulin, mealtime insulin, or insulin pump therapy within 8 weeks prior to screening.
5. Participated in clinical trials of any approved or unapproved investigational drug/treatment within the previous 1 month or 5 half-life period, whichever is longer, prior to screening.
6. Women who are pregnant, breastfeeding or planning to conceive, or women of childbearing potential are reluctant to use appropriate contraception during the trial and for at least 14 days after the last dose of the investigational medicinal drug; Anycircumstances that the investigator judges might not be suitable to participate in the trial..
The REAL Registry for Utilization of iFR in Assessing Coronary Stenoses

The purpose of this registry is to collect real life information and to document the performance and user friendliness of iFR in daily diagnostic practice and treatment strategies for MVD patients undergoing cardiac catheterization.

The REAL Registry will enroll a maximum of 3,000 patients in approximately 300 sites across multiple European and Middle East countries, where product has received CE approval and is marketed. An average of 10 cases with a maximum of 50 patients will be enrolled per participating site.

No follow-up will be performed. The REAL Registry will only collect data during diagnostic angiogram or PCI procedure, when performed.

Eligibility Criteria:
Inclusion Criteria:

* Over 18 year of age
* Willing to participate and able to understand, read and sign the informed consent document before the planned procedure
* Eligible for coronary angiography and PCI
* Coronary artery disease with at least two or more visually assessed coronary stenoses (greater than 40% diameter stenosis) in native, major epicardial vessel or its branches by coronary angiogram with an indication of physiological assessment.

Exclusion Criteria:

* Inability to obtain a signed informed consent from potential patient.
* Any contraindication for functional assessment as per the instructions per use and determined by the investigator.