cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy of Galvus as add-on Therapy to Metformin Plus Glimepiride

This study will evaluate the efficacy and safety of vildagliptin 50 mg bid as add-on therapy to metformin plus glimepiride in patients with Type 2 Diabetes (T2D).


Eligibility Criteria:
Inclusion criteria

* Confirmed diagnosis of T2DM by standard criteria.
* Treatment with oral anti-diabetic therapy, on stable dose for at least 12 weeks prior to the screening visit. Acceptable background anti-diabetic therapy includes: metformin (≥ 1500 mg) as monotherapy or in combination with SU, TZDs, or glinides
* Age: ≥18 to ≤ 80 years
* HbA1c of ≥ 7.5 and ≤ 11.0%
* Body Mass Index (BMI) ≥22 to ≤45 kg/m2

Exclusion criteria:

* FPG ≥ 270 mg/dL (≥ 15.0 mmol/L)
* Acute metabolic diabetes complications such as ketoacidosis or hyperosmolar state (coma) within the past 6 months
* Any of following within past 6 months: Myocardial infarction, TIA or stroke, coronary artery bypass surgery or percutaneous coronary intervention
* History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes
* Acute infections which may affect blood glucose control within 4 weeks prior to screening Other protocol-defined inclusion/exclusion criteria may apply
The Efficacy of Online Brief Positive Cognitive Behavior Therapy Compared to Traditional Cognitive Behavior Therapy

Positive Cognitive Behavioral Therapy (P-CBT) has emerged as the fourth Cognitive Behavioral Therapy waive, based on critiques brought to Cognitive Behavioral Therapy for being grounded in the deficit-based medical model. The study aim to identify which of the two Cognitive Behavioral Therapy approaches, Positive or Traditional, is more effective in a brief format in terms of improving emotional state, attaining goals, and changing attitudes in young adults.

This study is a randomized controlled trial that aims to explore the effectiveness of two Cognitive Behavioral approaches: Positive and Traditional, in terms of improving emotional state, attaining goals, and changing attitudes in young adults. Thirty-eight participants divided into two groups, received four therapy sessions for four weeks. The outcomes were measured four times: pre-, mid- (after two sessions), post-intervention (after four sessions), and at two-month follow-up.

Eligibility Criteria:
Inclusion Criteria:

Students in the master's program in psychology

Exclusion Criteria:

-
The Role of Parathyroid Hormone (PTH) in Low Bone Mass in Anorexia Nervosa

Decreased bone strength is a common and serious medical problem present in many women with anorexia nervosa, or disordered eating. Women with decreased bone strength are more likely to suffer broken bones than women with normal bone strength.

We are investigating whether a hormone that is naturally produced by the human body -- parathyroid hormone (PTH) -- can help strengthen the bones of women with anorexia nervosa.

Anorexia Nervosa affects 0.5-1% of college-age women in the US and is associated with a number of significant medical conditions including bone loss. A majority of women with anorexia nervosa have bone loss and 50% have bone mineral density measurements greater than 2 standard deviations below normative means. Bone loss in anorexia nervosa is characterized by a decrease in bone formation, therefore therapy with an anabolic agent may be an effective treatment approach. In a randomized, single-blinded, placebo-controlled trial, we will study the effects of parathyroid hormone on low bone mass in anorexia nervosa, specifically looking at the effects of parathyroid hormone on bone mineral density (primary outcome).

Eligibility Criteria:
Inclusion Criteria:

* Anorexia Nervosa
* Women, age 30-70 years
* Osteoporosis or history of clinical fractures (spine, wrist, hip or ribs)

Exclusion Criteria:

* Diseases known to affect bone metabolism
* Hyperparathyroidism
* Medications known to affect bone metabolism in last 12 weeks (or bisphosphonate use in last 1 year)
* Pregnant and/or breastfeeding
* Diabetes mellitus
* History of malignancy involving or affecting the bone, any active malignancy, and/or radiation therapy to the bone
* Fractures of a bone other than a finger or toe in last 1 year
Early Palliative Care on Quality of Life of Advanced Cancer Patients

This study compares two types of care - Standard Oncology Care (SOC) and SOC with early palliative care (EPC) (started within 8 weeks after diagnosis of advanced disease) to see which is better for improving the quality of life of patients with advanced lung, pancreas, gastric and biliary tract cancer. The study will use FACT-G questionnaire to measure patients' quality of life.

The patients will complete a baseline FACT-G questionnaire and then will be randomized to a study group.

Subjects who are randomized to Standard Oncology Care (SOC) will follow up with their treating oncologist. They will consult with the palliative care team at their request or at the request of the treating oncologist or of the family. They will complete FACT-G questionnaire at 12 weeks after enrollment.

Subjects who are randomized to the SOC with Early Palliative Care (EPC) will meet with a palliative care team (basically composed by a palliative care physician and a palliative care specialized nurse) at their next medical oncology or infusion visit. They will meet with the palliative care team at least every three weeks. They will complete FACT-G questionnaire at 12 weeks after enrollment.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed metastatic lung (NSCLC), pancreatic, gastric and biliary tract cancer, diagnosed within the previous 8 weeks; an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2; age ± 18 years; metastatic or locally advanced disease (but not susceptible of loco-regional treatments); eligibility to first-line chemotherapy ± biological agents; life expectancy more than three months; written informed consent provided; FACT-G questionnaire filled in at enrollment, before the randomization.

Exclusion Criteria:

* Patients already receiving care from the PC service or pretreated with chemotherapy ± biological
Westlake Sailing Cohort

Little is known about the dynamic change of human microbiome in different body sites including skin, mouth and gut during sailing. The present study aims to reveal the change of human microbiome in response to the sailing environment in a 1-month period, and its implication for human health.

This study will recruit a number of participants who are going to sail for mariana trench from Shenzhen, China. Characteristics of the participants will be described by a series of index of stool, urine, skin microbiota and tongue coating. All the biospecimen will be collected before and during the voyage. Stool at the 2nd, the 4th and the 12th week after the voyage and blood sample at the baseline will also be collected. Participants' mood states, health-related quality of life, fatigue score and sleep quality will be investigated with questionnaires throughout the 1-month period. Participants are asked to record diseases and symptoms, if any, when sailing. All the data will be used to analyse how microbiota change and be involved in human health during a voyage.

Eligibility Criteria:
Inclusion Criteria:

* Willingness and capability to complete the study protocol

Exclusion Criteria:

* Inability or unwillingness to approved to provide informed consent.
* Women who are pregnant or lactating.
International Multicenter Project Comparing Radiofrequency Ablation Versus Implantable Defibrillator After Well-tolerated Ventricular Tachycardia in Ischemic Heart Disease with Minimally Impaired Ejection Fraction

Evidence for the usefulness of the defibrillator in cases of preserved left ventricular ejection fraction and well-tolerated ventricular tachycardia (without cardiocirculatory arrest or syncope) is lacking, as no previous trials have included such patients. Additionally, sudden death in this particular population is low compared to other subgroups of patients with malignant ventricular arrhythmias.

On the other hand, numerous recent retrospective data show that ablation of ventricular tachycardia can reduce mortality, and also clearly reduces the number of recurrences in prospective studies.

Finally, a very low rate of sudden death was observed in a multicenter European retrospective study that we conducted, including patients with well-tolerated ventricular tachycardia in structural heart disease with minimally impaired ejection fraction and benefiting from ablation without implantation of defibrillator.


Eligibility Criteria:
Inclusion Criteria:

* ischemic heart disease with history of infarction - LVEF\> 35% (measured by MRI)
* sustained monomorphic ventricular tachycardia - without history of syncope or cardiac arrest -
* having signed informed consent
* affiliated to a social security system

Exclusion Criteria:

* transient regressive cause of ventricular tachycardia
* recent myocardial infarction (\<2 months)
* ventricular tachycardia by reentry from branch to branch
* serious conduction disturbances (with indication of stimulation)
* contraindication to the implantation of a defibrillator or to the performance of an ablation (life expectancy \<1 year, relevant comorbidities)
* pregnancy
* age \<18 years
* Patient under legal protection, guardianship or curatorship
The Long-term Efficacy of Electrical Pudendal Nerve Stimulation for the Urgency-Frequency Syndrome in Women

The purpose of this study is to determine whether electrical pudendal nerve stimulation with acupuncture needles as electrodes has a good long-term therapeutic effect on the urgency-frequency syndrome in women.

Urgency-frequency syndrome (UFS) is often refractory to pharmacotherapy. Electrical neuromodulation has proved to be valuable in this situation. The electrical neuromodulation therapies include transvaginal electrical stimulation (TES), percutaneous tibial nerve stimulation (PTNS), sacral nerve stimulation (SNS) and pudendal nerve stimulation (PNS). Their effects can be explained by modulation of reflex pathways at spinal and supraspinal levels.

TES is easily applicable but it is sometimes intolerable for many patients due to discomfort, mucosal injury and high intensity stimulation for acceptable outcome. SNS differs from TES by its continuous stimulation and close nerve contact. It has a high rate of success, but symptoms appear to recur almost immediately after discontinuation of the stimulation and at least 20% of the patients initially tested do not respond to a test procedure. Its disadvantages included invasiveness of the procedure, the high cost of treatment, the high surgical revision rate, device replacement and adverse events. Because pudendal nerve (PN) afferents are particularly important for the inhibitory effect on the voiding reflex and SNS only excites part of PN afferents, direct PN stimulation may be more effective. PNS can be used to treat UFS refractory to SNS, but this therapy also has the disadvantages similar to those of SNS. PTNS is minimally invasive, demonstrates efficacy, and is easily applicable and well tolerated, but the results of chronic PTNS treatment are unknown in initially successful patients and PTNS effects diminish over time.

By combining the advantages of PNS and PTNS and incorporating the technique of deep insertion of long acupuncture needles, we developed electrical pudendal nerve stimulation (EPNS). In EPNS, long acupuncture needles of 0.40 Х 100 or 125 mm were deeply inserted into four sacral points and electrified to stimulate the pudendal nerves. CT transverse plane at the coccygeal apex has showed that the position of the lower needle tip is similar to where (adjacent to PN at Alcock's canal) the Bion device is implanted for chronic PN stimulation. Besides the radiographic evidence, simultaneous records of perineal ultrasonographic PFM contraction, vaginal pressure and pelvic floor surface electromyogram in our previous study have proved that EPNS can exactly excite PN. Our previous study has also proved that EPNS has a good post-treatment effect on UFS in women. The purpose of the present study is to show the long-term efficacy of EPNS for UFS in women.

Eligibility Criteria:
Inclusion Criteria:

* ≥50% symptom improvement at the end of EPNS treatment

Exclusion Criteria:

* Lost to follow-up or dead at 5 years after the end of treatment
* The symptoms were further relieved by other therapies during follow-up
A Long-term Follow-up Study in Participants Who Received CS-101

This is a study to evaluate the long-term safety and efficacy of CS-101 in participants who received CS-101 in study CS -101-06 (NCT06024876),No investigational drug product will be administered in the study.

This is a study to evaluate the long-term safety and efficacy of CS-101 in participants who received CS-101 in study CS -101-06 (NCT06024876). Subjects in the CS-101-06 study will be entered into long-term follow-up of this study up to 15 years post-infusion at the completion of the last (12-month) followup visit after treatment with CS-101 Injection.

Eligibility Criteria:
Inclusion Criteria:

* Participants (or his or her legally appointed and authorized representative or guardian) must sign and date informed consent form (ICF) and, where applicable, an assent form
* Participants must have received CS-101 infusion in last study

Exclusion Criteria:

* There are no exclusion criteria
Study to Assess the Efficacy, Safety and Tolerability of Idebenone in the Treatment of Friedreich's Ataxia

This study is meant to assess the effectiveness of idebenone on neurological outcome measures in patients with Friedreich's Ataxia over a 6 months period.

The study involves 6 clinic visits and upon completion the possibility to join a 12 months extension study where all patients will receive high dose Idebenone.

Eligibility Criteria:
Inclusion criteria:

* Documented diagnosis of Friedreich's Ataxia (FRDA) with confirmed FRDA mutations
* Patients 8 - 17 years of age at baseline
* Patients with a body weight greater than 25 kg/55 lbs at baseline
* Patients able to walk at least 10 meters without accompanying person (ICARS Walking Capacities score ≤6) at screening and baseline
* Patients who in the opinion of the investigator are able to comply with the requirements of the study, including swallowing the study medication
* Negative urine pregnancy test at screening and baseline (female patients of childbearing potential)

Exclusion criteria:

* Treatment with idebenone, Coenzyme Q10 or vitamin E (if taken at a dose 5 times above the daily requirement) within the past month
* Patients with International Cooperative Ataxia Rating Scale (ICARS) score of greater than 54 or less than 10 at screening
* Pregnancy and/or breast-feeding
* Clinically significant abnormalities of clinical hematology or biochemistry including, but not limited to, elevations greater than 1.5 times the upper limit of normal of Aspartate Aminotransferase (AST; also known as GOT), Alanine Aminotransferase (ALT; also known as GPT) or creatinine
* History of abuse of drugs or alcohol
* Participation in the previous (Phase II) study of idebenone at the National Institutes of Health (NIH)
* Participation in a trial of another investigational drug within the last 3 months
A Long-Term, Follow-On Safety Study of Four Doses of OPC-8212 (Vesnarinone) in HIV-Infected Persons

To examine the continued safety and tolerability of four doses of vesnarinone in HIV-infected patients who have completed a short-term study (less than 12 months on continuous treatment) of the drug.

Patients who have completed a limited duration study (less than 12 months of continuous treatment) of vesnarinone on protocols FDA 234A or FDA 234B and who have no current signs or symptoms of AIDS-defining illnesses may roll over to this study and continue receiving their regimen of vesnarinone for 12 months beyond their original participation.

Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed:

* Chemoprophylaxis for Pneumocystis carinii, candida, and mycobacteria.
* Acyclovir for acute treatment of herpes.

Exclusion Criteria

Concurrent Medication:

Excluded:

* Antiretroviral agents, including ddI, ddC, AZT, and d4T.
* Immunosuppressive agents.
* Investigational HIV drugs/therapies including vaccines.
* Interferon or other immunomodulating agents.
* Corticosteroids (other than topical).
* Megestrol acetate.
* Agents known to cause neutropenia.
* Ganciclovir.
* Cytotoxic chemotherapy.

Concurrent Treatment:

Excluded:

* Radiation therapy.

Patients with the following prior conditions are excluded:

* Poor compliance (less than 80 percent of drug taken) on the Phase I protocol (FDA 234A or FDA 234B).
* Missed more than one clinic visit on the Phase I protocol.

Prior Medication:

Excluded:

* Acyclovir as prophylaxis for herpes within 48 hours prior to study entry.

Patients meet the following criteria:

Successful completion of short-term therapy with vesnarinone on FDA 234A or FDA 234B.

Active illicit drug abuse.
Comparison of Method for Skin Closure in Colorectal Cancer.

Compared to tissue adhesives and skin stapling devices, tissue adhesives are reported to have advantages in terms of wound infection and cost competitiveness. However, there have been no prospective randomized studies focusing on wound infection rates and cost competitiveness between skin stapling devices and tissue adhesives in colorectal cancer surgery.

In colon cancer surgery, it is still unclear which skin suturing method has advantages such as lower postoperative wound infection rate and price competitiveness. The purpose of this study is to compare clinical outcomes, including wound infection rates and cost-effectiveness, between two different wound closure methods for colorectal cancer.

The primary purpose of the study is to compare and analyze the incidence of surgical site infection within 30 days after surgery in each group when tissue adhesive was applied and when skin stapling device was applied.

The purpose of the secondary study is to compare the clinical results after surgery by analyzing cost-effectiveness, pain level, and satisfaction after surgery between existing skin stapling and tissue adhesive for colon cancer patients.

Post-operative wound infection rate, cost (material costs of staplers, adhesives, material costs and service fees for disinfecting wounds occurring in the week after surgery), sex, age, BMI (body mass index), ASA (Anesthesiologists category), past history (diabetes, smoking history) , past abdominal surgery history), cancer stage, pre- and post-operative blood test results (WBC, CRP), biopsy results (cancer type), surgery time, pain on the 1st and 3rd days after surgery (VAS), length of stay, postoperative complications , compare the postoperative results of satisfaction.

Eligibility Criteria:
Inclusion Criteria:

* underwent elective colorectal surgery
* aged 19 to 80 years
* ASA (American Society of Anesthesiologists) score: 1, 2
* surgical approach such as laparoscopic or Robotic Xi platform

Exclusion Criteria:

* ASA score above 3
* Aged over 80 years
* underwent combined surgery for other organ resection
* uncontrolled DM
Ibd CAncer and SeRious Infections in France (I-CARE 2)

This is a French prospective longitudinal observational multicentre cohort study.

Primary objective : to assess prospectively the presence and the extent of safety concerns (cancer, serious infections, arterial and venous thrombotic events) in patients with CD and UC and treated with JAKi, anti-IL23p19, and S1p modulators.

Number of patients : 6 000 at least Participating investigators : 250 at least

Recruitment period : 3 years 6 months

Primary objective : to assess prospectively the presence and the extent of safety concerns (cancer, serious infections, arterial and venous thrombotic events) in patients with CD and UC and treated with JAKi, anti-IL23p19, and S1p modulators.

Secondary objectives :

* To assess the presence and the extent of safety concerns in patients treated with JAKi, anti-IL23p19, and S1p modulators for each outcome of interest separately (cancer, serious infections, arterial thrombotic events, venous thrombotic events)
* To investigate prospectively the impact of JAKi, anti-IL23p19 and S1p modulators strategies on the natural history of IBD and their potential for disease modification by collecting validated surrogate markers such as mucosal healing and disease complications such as bowel damage (strictures, fistulas, abscess), surgeries, and hospitalizations
* To assess the evolution of ePROs on a trimester basis and the impact of JAKi, anti-IL23p19, and S1p modulators on ePROs in IBD
* To evaluate the benefit-risk ratio of strategies based on a wider use of JAKi, anti-IL23p19, and S1p modulators therapy for IBD
* To assess the healthcare costs and cost-efficacy of current therapeutic strategies in IBD.

Eligibility Criteria:
Inclusion Criteria:

* Patient with an established diagnosis of Crohn's disease, ulcerative colitis or IBD unclassified based on usual radiological, endoscopic or histological criteria.
* Patient aged 18 and older accepting to sign the informed participating consent form, stating that he accepts to provide personal details (mobile and home phone number, e-mail address), to complete the e-PRO as required and to be contacted by a Study Coordinator and his gastroenterologist for the purpose of the study during the entire study period and during follow up if required.

Exclusion Criteria:

* Patient unable to sign the informed consent form
* Patient with no regular access to internet
* Patient refusing to sign the informed consent form
* Patient enrolled in a Randomized Clinical Trial (If the investigational product received was blinded, and if the treatment is unknown at time of enrolment in I-CARE 2)