cyrilzakka/clinical-trials huggingface dataset:
A Study of Safety & Blood Levels of IDL-2965 in Healthy Subjects and Patients With a Special Type of Pulmonary Fibrosis

The purpose of this study is to test the safety and tolerability of the drug candidate IDL-2965 and to see how it is absorbed, processed, and removed by the body.

IDL-2965 is an oral integrin antagonist antifibrotic being studied as a potential treatment for IPF and Nonalcoholic Steatohepatitis (NASH). This double-blind, randomized, placebo-controlled, single and multiple oral dose study will be conducted in 3 parts. Part A will comprise a single-dose, sequential-group design in healthy subjects, incorporating a food-effect evaluation. Part B will consist of a multiple-dose, sequential-group design in healthy subjects. Part C will be a multiple-dose, sequential-group design in subjects with IPF.

Eligibility Criteria:
Inclusion Criteria:

Healthy subjects:

• Male and female subjects aged between 18 and 60 years, with a body mass index between 18.0 and 32.0 kg/m2.

IPF subjects:

* Male and female subjects over 40 years of age.
* Diagnosis of idiopathic pulmonary fibrosis
* Idiopathic pulmonary fibrosis has been stable for at least 3 months.

Exclusion Criteria:

Healthy subjects and IPF subjects:

* Significant history or clinical manifestation of any disease/disorder, other than IPF.
* History of significant hypersensitivity, intolerance, or allergy to any drug compound
* Poor peripheral venous access
* Use or intend to use any medications, tobacco or nicotine containing products or electronic cigarettes.
* History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs

IPF subjects:

• Pulmonary function tests and other diagnostic procedures inconsistent with diagnosis of idiopathic pulmonary fibrosis.
Role of Surgery in Advanced Ovarian Cancer

To demonstrate that ultra-radical surgery with multiple visceral resections and high tumor burden prior to surgery independently reduces the survival of patients with advanced ovarian cancer treated with complete cytoreductive surgery.

Primary objective :

To demonstrate that ultra-radical surgery with multiple visceral resections and high tumor burden prior to surgery independently reduces the survival of patients with advanced ovarian cancer treated with complete cytoreductive surgery.

Secondary objectives:

1. Demonstrate that, in patients with advanced ovarian cancer (FIGO stage IIIC-IVB) treated by complete cytoreduction surgery, the high tumor load before surgery decreases survival. / Evaluate whether there is a sub-group of patients at risk for whom the high tumor burden prior to surgery reduces survival.
2. Demonstrate that, in patients with advanced ovarian cancer (FIGO stage IIIC-IVB) treated by complete cytoreduction surgery, the extension of carcinomatosis to the upper abdomen reduces the chances of survival. / Assess whether there is a subgroup of patients at risk for whom the extension of carcinomatosis to the upper abdomen reduces survival.
3. Demonstrate that, in patients with advanced ovarian cancer (FIGO Stage IIIC-IVB) treated by complete cytoreduction surgery, invasion of the celiac lymph nodes reduces survival rates. / Assess whether there is a subset of patients at risk where the invasion of the celiac lymph nodes reduces survival.
4. Demonstrate that, in patients with advanced ovarian cancer (FIGO stage IIIC-IVB) treated with complete cytoreduction surgery, combination with surgical procedures reduces survival. / Evaluate whether there is a sub-group of at-risk patients for whom the combination of surgical procedures with ultra-radical surgery reduces survival.

Eligibility Criteria:
Inclusion Criteria:

* confirmed histological diagnosis of ovarian epithelial cancer
* complete cytoreduction surgery

Exclusion Criteria:

* women under 18 years or presence of residual tumor \>2.5mm after surgery or lack of data on performed surgical procedures or surgery performed before 2008, January or after 2015, Decembrer.
The Effect of Remote Preconditioning on the Exercise Performance of the Elite Swimmers

In this study, we will test the hypothesis that preconditioning highly trained swimmers using skeletal muscle ischemia as the stimulus will improve exercise performance assessment.

The main purpose of this study is to determine if it is possible to precondition competitive swimmers and improve their exercise performance to provide further insight into the physiological mechanisms through which preconditioning may function. With four 5 minute inflation cycles of a blood-pressure cuff, we will induce skeletal muscle ischemia which is known to be a powerful method of preconditioning. Each swimmer will be blinded to the expected effect and randomly assigned to real preconditioning versus the sham intervention which will consist of four 5 minute cycles of blood pressure cuff inflation to 10mmHg. During a subsequent training session, the subjects will receive the intervention they have not received during the previous test session. Therefore, each subject will be part of both study groups and will serve as their own control. To evaluate the exercise performance, the subjects will perform an incremental swimming test protocol based on methods developed and reported by a member our research team. Swimming velocity, blood lactate level, heart rate, breathing frequency, dyspnoea and oxygen saturation will be measured during incremental exercise. Finally, we would like to determine the preconditioning effect of regular exercise training in an animal model.

Exercise performance is thought to be limited by skeletal, cardiac and respiratory muscle fatigue associated with episodes of exercise induced arterial hypoxemia. Preconditioning is defined as a period of brief lack of oxygen or ischemia in a tissue that protects the heart or any other organ from another sustained episode of ischemia. Preconditioning is believed to improve exercise performance by protecting the skeletal, cardiac and respiratory muscles against decreased oxygen and by-products of anaerobic metabolism that may limit an individual's exercise performance. Elite athletes, such as highly trained swimmers, may provide the research team with the opportunity to evaluate the effect of preconditioning during local tissue hypoxia and anaerobic metabolic by-products in healthy adolescents, which is otherwise not possible. With this study, we will show if it is possible to precondition competitive swimmers and improve their exercise performance using ischemia of the limb as a preconditioning stimulus.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female athlete volunteers
* Post-pubescent swimmers between the ages of 13 and 22 years (or healthy non-athletes (for the "equipment control" group and for the control arm for the animal model section)
* Members of competitive swimming teams
* Have achieved a swimming performance time within 5% of national qualification standards

Exclusion Criteria:

* Illness, surgery, or medical intervention within the last 48 hours
* Diabetes mellitus
Effectiveness of a Decision Aid for Knee Osteoarthritis

The main goal of this study is assess the effectiveness of a DA for patients with knee osteoarthritis candidates to ART

The number of knee total arthroplasty (ART) interventions has increased in the last 10 years in European countries, partly due to the aging of the population and partly because of the increase in the use of these interventions to improve the quality of life among elderly patients. According to the Organization for Economic Cooperation and Development (OECD) 2012, from 2000 to 2010 in Spain the percentage of knee ART has doubled in recent years. .

The role of citizens in decisions affecting their health is changing. Individual factors such as improving educational attainment and access to medical information, and collective factors such as training of patient groups and changes in legislation (informed consent, autonomy principle) have motivated the transition from a paternalistic model to a co-responsibility model. Shared decision-making (TDC) has been proposed in recent years as a model of care that promotes users' involvement in the decisions about their treatment, in those situations where there is uncertainty and / or the scientific evidence reports a balance between benefits and risks that is similar for two or more therapeutic options. Decision aids (DA) are tools designed to promote and facilitate patients' involvement in medical decisions concerning their health

Objectives:

To assess the effectiveness of a DA for patients with knee osteoarthritis candidates to ART

Methodology:

Randomized controlled trial to evaluate the effectiveness of the DA versus usual care in reducing decisional conflict, increasing knowledge of the disease/treatments, informed choice and the satisfaction with the decision making process, and decreasing decisional regret.

Eligibility Criteria:
Inclusion Criteria:

* Patients with osteoarthritis of the knee
* Candidates for arthroplasty

Exclusion Criteria:

* Patients who have already undergone knee arthroplasty
* Patients younger than 18 years
Rehabilitation Planning Consult Phase II Trial

The study will evaluate the efficacy of the Rehabilitation Planning Consult (RPC) to achieve key rehabilitation outcomes in survivors of head and neck cancer compared to a waiting list control group. The RPC is a consultative intervention that teaches survivors to use self-management and problem solving strategies to meet and attain individualized goals. Follow-through with plans and goal attainment are facilitated by a Rehabilitation Consultant. Results from this study will be used to plan for a larger multi-site trial and subsequent real world implementation.

Survivors of head and neck cancer (HNC) often have significant impairments, functional limitations, and reduced quality of life (QL). Rehabilitation services, such as speech-language pathology to improve swallowing, physiotherapy to improve neck mobility, and occupational therapy to enable return to work, can effectively reduce the impact of impairments, restore function, and improve QL. However, access to rehabilitation for survivors of HNC is extremely limited. A trans-professional self-management program is needed to provide resources, links to community providers, and instruction in problem-solving strategies. The program should fit seamlessly into the cancer care system with minimal additional resources. To meet these specifications, an innovative intervention, the Rehabilitation Planning Consult (RPC), was developed and evaluated. The RPC is delivered in 1 to 2 sessions and, in a single arm pilot study, had a moderate to large effect on several aspects of QL and individualized goal attainment. It remains unknown whether the RPC is efficacious in comparison to standard care. In preparation for a Phase III trial, the effect of the RPC, as compared to a standard care control will be estimated, on HNC survivors' QL, attainment of individualized goals, and self-efficacy related to self-management. To facilitate recruitment and ensure ethical provision of services, participants will be randomized to a waiting list control (WLC) or RPC. Assessments will be conducted at three time points for the RPC group and four times for the WLC group. Based on pilot data, approximately 43% of the RPC group are expected to achieve a minimal important difference (MID) in QL, thus 56 participants per arm, 112 participants total, will be recruited. The primary outcome will be QL related to physical health, measured using the SF-36 Physical Component Summary Score (PCS). Secondary measures will include individualized goal performance measured using the Brief Rehabilitation Assessment for Survivors of HNC, disease-specific QL measured with the FACT-HN, and self-efficacy.

Eligibility Criteria:
Inclusion Criteria:

* Survivor of head and neck cancer
* Completed treatment in the past 6 months

Exclusion Criteria:

* Cognitive issues
* Communication issues
* Presence of major comorbidities
Lumbopelvic Control in Baseball Batting

Baseball batting is important to winning the games. Baseball batting is achieved by proximal-to-distal sequencing of body movements and controlled by the neuromuscular system. Poor lumbopelvic control could influence production and transfer of energy in the kinetic chain. This study aims to investigate the impact of lumbopelvic control in hitting mechanics and bat swing velocity in high school baseball players.


Eligibility Criteria:
Inclusion Criteria:

* Sport specialization in baseball batting
* Active players on college baseball teams

Exclusion Criteria:

* History of surgery in the lumbar area
* Severe musculoskeletal or neurological symptoms that interfere with participation in competition, training and test
A Research Study About Weight Loss and Treatment Patterns With the Use of Saxenda® in Adults in Real-life Settings in Switzerland

The study is investigating weight loss and treatment patterns associated with the use of Saxenda® in adult patients.

The aim of the study is to assess the weight loss associated with Saxenda® in patients with obesity or overweight. Saxenda® was prescribed to participants by study doctor independently of this study.

The study will last for about 4 months, where the data will be collected from the available medical records.

There will be no additional activities expected from participants in the scope of study because it is a chart-review study.


Eligibility Criteria:
Inclusion Criteria:

* Signed consent (general consent for research or study-specific informed consent) obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
* Male or female, aged 18 to 74 years (both inclusive) at the time of Saxenda® initiation.
* Have been prescribed Saxenda® for weight management.
* For the reimbursed cohort, per the Swiss reimbursement criteria: BMI greater than or equal to 35 kg/m\^2 or a BMIgreater than or equal to 28 and below 35 kg/m\^2 with additional weight related comorbidities (pre diabetes or T2D (Type 2 Diabetes Mellitus), hypertension, dyslipidaemia), prior to receiving the Saxenda® treatment.
* For the non-reimbursed cohort, BMI greater than or equal to 30 kg/m\^2 or a BMI greater than or equal to 28 kg/m\^2 with additional weight related comorbidities (pre diabetes or T2D, arterial hypertension, dyslipidaemia), prior to receiving the Saxenda® treatment.
* The decision to initiate treatment with commercially available Saxenda® has been made by the patient/legally acceptable representative (LAR) and the treating physician before and independently from the decision to include the patient in this study.
* Baseline weight measurement within 3 months of Saxenda® initiation/prescription.
* At least one weight assessment post-Saxenda® initiation/prescription.

Exclusion Criteria:

* Previous participation in this study. Participation is defined as having given informed consent in this study.
* Treatment with any investigational drug within 30 days of Saxenda® prescription/initiation.
* Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
* Concomitant treatment of Saxenda® with other GLP 1 (Glucagon-like peptide-1) receptor agonists, or orlistat.
* Concomitant treatment with sodium/glucose cotransporter-2 inhibitors (SGLT 2i), dipeptidyl peptidase-4 (DPP 4i), or insulin for the reimbursed cohort only.
* Patients who have been treated with any obesity medication for last 12 weeks prior to initiation of Saxenda® treatment.
* Patients who have previously been treated with a GLP 1 receptor agonist for the reimbursed cohort only.
* Patients who have undergone bariatric surgery at any time before starting Saxenda® treatment.
* Patients initiating Saxenda® treatment after 31 October 2020.
A Study to Evaluate the Impact of 11-month Ticagrelor Monotherapy Following One-month DAPT After PCI

PIONEER IV CHINA is sought to investigate the safety and efficacy of 11-month ticagrelor monotherapy following one-month dual antiplatelet therapy (DAPT) after HT Supreme drug-eluting stent system at 12 months follow-up.

This study is a prospective, multi-center, single-arm objective performance criteria clinical trial in an all-comers patient population (including patients with high bleeding risk, HBR) undergoing PCI with unrestrictive use of the HT Supreme sirolimus-eluting stent and treated with 11-month ticagrelor monotherapy following one-month dual antiplatelet therapy (DAPT) in approximately 285 patients (including 80 coronary heart disease cases entering the OCT subgroup). All patients will be (at minimum) contacted via visit at 30 days (±7 days) and at 12 months (±30 days), and by phone contact at 6 months (±14 days), 24 months (±30 days) and 36 months (±45 days) post index procedure to assess clinical status and adverse events. The Primary Endpoint for this trial is Patient-oriented Composite Endpoint (PoCE) at 12 months post-procedure.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female patient ≥18 years of age;
2. Patient has chronic stable angina, acute coronary syndromes or silent ischemia;
3. Presence of one or more coronary artery stenoses of ≥50% (by visual assessment) in a native coronary artery (with or without prior stent/other device treatment) or in a saphenous venous or arterial bypass conduit suitable for coronary stent implantation;
4. The vessel should have a reference vessel diameter of at least 2.25 mm by visual assessment (no limitation on the number of treated lesions, vessels, or lesion length);
5. Patient has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the Ethical Committee and is willing to comply with all protocol-required (follow-up) evaluations.

Exclusion Criteria:

1. under 18 years of age;
2. Unable to sign written informed consent
3. Patient is a woman who is pregnant or nursing
4. Known intolerance to cobalt chromium, and medications such as sirolimus, aspirin, heparin, bivalirudin or P2Y12 inhibitors;
5. Planned major elective surgery requiring discontinuation of DAPT within 12 months of procedure;
6. Concurrent medical condition with a life expectancy of less than 3 years;
7. Currently participating in another trial and not yet at its primary endpoint
8. Active pathological bleeding;
9. History of intracranial haemorrhage.

OCT exclusion criteria

1. Left main lesion
2. Severe tortuous, calcified or angulated coronary anatomy of the study vessel that in the opinion of the investigator would result in suboptimal imaging or excessive risk of complication from placement of an OCT catheter
3. Total occlusion or thrombolysis in myocardial infarction(TIMI) flow 0, prior to wire crossing.
Effect of Sacral Nerve Stimulation on Enteric Nervous System

Sacral nerve stimulation (SNS) is a new therapeutic option to treat fecal incontinence, although its mecanims of action remains poorly understood. The investigators hypothtized that SNS could act on enteric nervous system (ENS). To verify this hypothesis, the investigators will collect biopsy samples from patients implanted for SNS, and assess whether SNS induces changes in ENS.

Sacral nerve stimulation (SNS) is a new therapeutic option to treat fecal incontinence. Its efficacy yields 80% approximately, but its mecanims of action remains poorly understood. In particular, SNS does not restore anal squeezing contraction nor it increase anal tone. Recently, using a porcine model, it was shown that SNS changed colonic permeability, suggesting that SNS may activate the enteric nervous system (ENS).

The investigators hypothtized therefore that SNS could act on enteric nervous system (ENS).

To verify this hypothesis, the investigators will collect biopsy samples from patients before and after implantation for SNS. The investigators will assess whether SNS induces changes in ENS, and if this is correlated to SNS efficacy.

Eligibility Criteria:
Inclusion Criteria:

* Fecal incotinence
* refractory to medial treatment
* Eligible to a treatment with sacral nerve stimulation

Exclusion Criteria:

* age \< 18 yo
* age \< 75 yo
* anal defect \> 120°
* bilateral interruption of the bulbo-cavernous reflex
* patient not able to speack and understand the French Language
* patient not affilated to the French healthcare system
* pregnancy
Sleep Apnea and Oxidative Stress and Nitric Oxide

Background: Previous studies present contradictory data concerning obstructive sleep apnea syndrome (OSAS), lipid oxidation and nitric oxide (NO) bioavailability. This study was aimed: (1) to compare the concentration of 8-isoprostane and total nitrate and nitrite (NOx) in plasma of middle aged males with OSAS and no other known comorbidity and carefully matched healthy controls of the same age and gender; and (2) to test the hypothesis that nasal continuous positive airway pressure (CPAP) therapy, might attenuate oxidative stress and nitrate deficiency.

We performed a single-center, prospective, randomized, double-blind, placebo-controlled and cross-over clinical study, in which patients received CPAP and sham therapy for two 12-week periods. Baseline measurements in healthy controls matched for age and gender were also obtained. At recruitment, 24-h blood pressure monitoring (ABPM), an echocardiogram (to rule out any cardiac dysfunction) and a sleep study was obtained in all participants . After fasting overnight, a venous blood sample (anti-coagulated with dipotassium EDTA, for 8-isoprostane and total nitrate and nitrite concentration (NOx) determinations) and a urine sample were collected in all of them between 08:00 and 10:00 hours. Within 30 minutes of blood collection, plasma was obtained by centrifugation at 3000 rpm for 15 min. All plasma samples were stored at -60°C until analysis. Patients with OSAS underwent a full-night CPAP titration study using an automated pressure setting device (Auto Set; ResMed, Sydney, Australia). Compliance with therapy was obtained from a built-in run-time counter. After 12 weeks, CPAP device was switched to the alternate mode of therapy and ABPM,, plasma and urine sampling were repeated in patients

Eligibility Criteria:
Inclusion Criteria:

* apnea-hypopnea index (AHI) ≥10 h-1
* excessive daytime sleepiness defined by an Epworth scale score ≥11 points
* no treatment for OSAS. Inclusion criteria for healthy control subjects were AHI \<5 h-1 and Epworth sleepiness scale \<10.

Exclusion Criteria:

* unwillingness or inability to participate in the study
* obstructive or restrictive lung disease as identified by pulmonary function testing
* use of cardioactive drugs
* cardiac rhythm disturbances, including sinus bradycardia and sinus tachycardia
* known arterial hypertension, or 24-hour mean blood pressure of 135 and/or 85 mm Hg or more
* left ventricular ejection fraction \<50%, ischemic or valve heart disease, hypertrophic, restrictive or infiltrative cardiomyopathy, pericardial disease or stroke, by history, physical examination, ECG, chest radiography, conventional exercise stress testing, and echocardiography
* diabetes mellitus, by history or 2 random blood glucose levels ≥126 mg/dl
* morbid obesity (body mass index \>40 Kg/m2)
* daytime hypoxemia (PaO2 \<70 mm Hg) or hypercapnia (PaCO2 \>45 mm Hg)
* need to change medication
* hospital admission for 10 or more days
* average nightly CPAP usage less than 3.5 hours.