cyrilzakka/clinical-trials huggingface dataset:
Intracoronary Stem Cell Therapy in Patients With Acute Myocardial Infarction (SCAMI)

Autologous stem cells may improve myocardial regeneration after intracoronary administration in patients with acute myocardial infarction. The primary hypothesis of this prospective, placebo-controlled, double-blind trial is that the increase of ejection fraction determined by magnetic resonance imaging between baseline and 6 months follow-up is superior in active treated patients compared to patients receiving placebo. The study includes an integrated pilot phase of 40 patients for evaluation of left ventricular ejection fraction determined by cardiac magnetic resonance imaging. Based on the data of this analysis the final sample size will be calculated. The primary endpoint is the improvement in left ventricular ejection fraction with an assumed 2.5% higher improvement in the cell treated population compared to the placebo treated group.

There is a 2:1 randomization for bone marrow cell therapy versus placebo therapy. Patients will be stratified according to age, localization of myocardial infarction and left ventricular function.

Eligibility Criteria:
Inclusion Criteria:

* acute myocardial infarction with time to revascularization \>6 hours from symptom start
* clear target vessel
* large myocardial infarction defined as: proximal vessel occlusion, CK \> 1000 U/L, myocardial scar in magnetic resonance imaging \> 10% of left ventricular muscle mass
* potential prior thrombolysis
* written informed consent

Exclusion Criteria:

* acute myocardial infarction with revascularization within 6 hours after symptom start
* prior myocardial infarction
* no clear target vessel
* contraindication for magnetic resonance imaging (e.g. pacemaker, ICD)
* severely depressed left ventricular ejection fraction (less than 20% in magnetic resonance imaging)
* prior hematologic disease
* prior chemo therapy
* prior stem cell transplantation
* prior treatment with G-CSF
* known alteration of the bone marrow by alcohol or drugs, e.g. agranulocytosis
* local infection of puncture sites
Treatment Comparison in Chronic Pain

Chronic pain concernes one in four adults in Belgium. Because of the psychological and social repercussions, a biopsychosocial approach is necessary in order to improve the quality of life of people suffering from chronic pain. Non-pharmacological techniques such as hypnosis, self-care learning, music-therapy and psycho-education are gaining more and more interest in the scientific field. Indeed, several studies have shown a reduction in psychological distress and an improvement in global quality of life after having learned self-hypnosis/self-care. Furthermore, other studies focusing on music as a treatment for chronic pain highlight an analgesic effect of music over pain and a reduction of common comorbidities. Nevertheless, only few studies aim at comparing these techniques to each other. The aim of our study would be to compare a 7 months learning program of self-hypnosis/self-care, music-therapy/self-care, motivation to learn self-hypnosis/self-care and self-care alone in order to highlight the most efficient treatment for chronic pain.


Eligibility Criteria:
Inclusion Criteria:

* Major
* Fluency in French
* Chronic pain diagnosis

Exclusion Criteria:

* Neurologic disorder
* Psychiatric disorder
* Drug addiction
* Alcoholism
A Study of Milvexian Versus Apixaban in Participants With Atrial Fibrillation

The purpose of this study is to evaluate if milvexian is at least as effective as apixaban for reducing the risk of the composite stroke and non-central nervous system (CNS) systemic embolism.


Eligibility Criteria:
Inclusion Criteria:

* Minimum age of 18 years
* Medically stable and appropriate for chronic antithrombotic treatment
* Atrial fibrillation eligible to receive anticoagulation
* Participant must satisfy one or both of the following categories of risk factors (a or b): a) one or more of the following risk factors: i) age greater than or equal to 75 years, ii) history of any type of stroke including symptomatic stroke of any kind. b) two or more of the following risk factors: i) age between 65 and 74 years, ii) hypertension, iii) diabetes mellitus, iv) atherosclerotic vascular disease, v) heart failure

Exclusion Criteria:

* Hemodynamically significant valve disease or those with valve disease that will potentially require surgical valve replacement during the study
* Any condition other than AF that requires chronic anticoagulation
A Study to Assess How Food Affects the Safety and Pharmacokinetics of Galicaftor and Navocaftor

Cystic Fibrosis (CF) is a rare, life-threatening, genetic disease that affects the lungs and digestive system, significantly impairing the quality of life, with those affected having a median age of death at 40. The objectives of this study are to assess the effect of food on the safety and pharmacokinetics of navocaftor and galicaftor.


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) is =\> 18.0 to \<= 32.0 kg/ m2 after rounding to the tenth's decimal.
* A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead electrocardiogram (ECG).

Exclusion Criteria:

* History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, hematologic, or psychiatric disease or disorder, or any uncontrolled medical illness.
* History of or active medical condition(s) or surgical procedure(s) that might affect gastrointestinal motility, pH, or absorption \[e.g., Crohn's disease, celiac disease, gastroparesis, short bowel syndrome, gastric surgery (except pyloromyotomy for pyloric stenosis during infancy), cholecystectomy, vagotomy, bowel resection, etc.\].
* Evidence of dysplasia or history of malignancy (including lymphoma and leukemia) other than successfully treated non-metastatic cutaneous squamous cell, basal cell carcinoma or localized carcinoma in situ of the cervix.
FODMAPs and Refractory GERD

The aim of this study is to determine the effects of a low Fermentescible Oligosaccharides Disaccharides Monosaccharides and Polyols (FODMAP) diet in patients with documented refractory GERD on proton pump inhibitor (PPI) therapy.

Colonic fermentation has been shown to influence oeso-gastric motility : increased gastric relaxation, increased rate of lower esophageal sphincter relaxation. Experimental increased colonic fermentation (FOS in diet) increase the occurrence of reflux events in patients with GERD. The aim of this study is to compare the low-FODMAP diet and classical GERD dietary recommendations (avoid fatty meals, head of bed elevation etc..) in patients with refractory GERD symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18
* Affiliation to French Social Security
* Informed written consent
* RDQ score \> 3
* Abnormal pH-impedance monitoring on PPI twice daily (since 3 months) according to normal values published by Zerbib et al (CGH 2013)

Exclusion Criteria:

* Pregnancy or breast feeding
* Women of childbearing potential without an effective method of contraception
* Person under guardianship
* History of thoracic of abdominal surgery (excepted appendectomy and cholecystectomy)
Bortezomib in Combination With Liposomal Doxorubicin and Dexamethasone to Treat Plasma Cell Leukemia

Bortezomib/Liposomal doxorubicin (V-DD) is preferred to bortezomib single agent in salvage therapy for Multiple Myeloma (MM).

The present study is designed to assessment the efficacy and safety study of Bortezomib in combination with Liposomal Doxorubicin and Dexamethasone in treatment of Plasma Cell Leukemia (PCL).

Primary study endpoint is the overall response rate (sCR+CR+VGPR+PR). Secondary endpoints is the rate of complete response (sCR+CR), partial remission rate (VGPR + PR), duration of response (DOR), overall survival (OS).

Patient with Plasma Cell Leukemia(PCL ) and multiple myeloma (MM); KPS ≥ 60scores

Eligibility Criteria:
Inclusion Criteria:

* Patients confirmed relapsed or refractory PCL who previously untreated or never received treatment with Bortezomib
* KPS ≥ 60
* Adequate liver and renal function within 2 weeks of Screening:
* Bilirubin ≤ 1.5 × the upper limit of normal (ULN)
* Alanine aminotransferase (ALT) ≤ 2.5 × the upper limit of normal (ULN)
* Aspartate aminotransferase (AST) ≤ 2.5 × the upper limit of normal (ULN)
* Cardiac function \> Ⅲ grade and ejection fraction \> 45%
* Signed informed consent prior to initiation of any study-related procedures that are not considered standard of care

Exclusion Criteria:

* has taken Bortezomib
* KPS ≤ 60 scores
* mental illness
Motivation to Exercise in People With Anorexia Nervosa

The purpose of this research study is to determine the importance and level of physical activity in people with Anorexia Nervosa.

A laboratory paradigm that uses a progressive ratio computerized work task will be used to determine the reinforcing value of exercise in hospitalized patients with AN, both before and after weight gain. In addition, we will examine the relationship between the reinforcing value of exercise and free-living physical activity in this population. We will also examine the relationship between the reinforcing value of exercise and measures of depression, anxiety, and cortisol, which we have found in previous studies to be associated with other measures of physical activity and exercise motivation. In order to determine whether physical activity in women with AN differs from that of non-eating disordered women, we will extend studies of physical activity to free-living control participants. All adult patients and controls will undergo body composition assessment once to measure the association between physical activity and percent body fat. Finally, to determine the impact of exercise reinforcement and physical activity on outcome in women with AN, we will conduct follow-up assessments in all patient participants for one year after discharge from the inpatient treatment unit."

Eligibility Criteria:
Inclusion Criteria:

* DSM-IV diagnosis of Anorexia Nervosa (except amenorrhea)
* Female
* Age 18-45
* Medically Stable for exercise participation
* At a minimum of 75% Ideal Body Weight

Exclusion Criteria:

* Significant or current past medical illness including diabetes mellitis and heart disease
* Current or lifetime history or schizophrenia, bipolar disorder, or other psychotic disorder as defined by DSM-IV-TR
* Current suicidal ideation or recent suicidal behavior (within past 3 months)
* Drug or alcohol abuse in last 6 months
* Taking psychotropic medication
* Pregnancy
Investigation of the Efficacy of Non-Invasive Vagus Nerve Stimulation and Physiotherapy in Unilateral Vestibular Hypofunction Patients

The purpose of this study: To investigate the effectiveness of non-invasive vagus nerve stimulation and vestibular rehabilitation applications in patients diagnosed with Unilateral Vestibular Hypofunction (UVH).

It was planned to include 40 patients diagnosed with UHV in the study. Patients were randomized into 2 separate groups (20 people in the vestibular rehabilitation group, 20 people in the vagus nerve stimulation group in addition to vestibular rehabilitation).

Eligibility Criteria:
Inclusion Criteria:

* He learned about unilateral peripheral vestibular hypofunction with videonystagmography
* Being able to communicate well

Exclusion Criteria:

* Having cognitive impairment
* Presence of central neurological disease
* Lack of cooperation
* Previous ear surgery
* Accompanied by Benign Proxysmal Positional Vertigo
* Having acute Meniere's disease
* Finding pathology in temporal bone MRI
* Having a lower extremity disorder that prevents walking
* Evidence of central pathology in videonystagmography results
Study to Evaluate the Effectiveness of a High-Dose Quadrivalent Influenza Vaccine (QIV-HD) Compared to a Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD) in Adults 65 Years of Age and Older

Primary Objective:

To demonstrate the superior relative effectiveness of QIV-HD as compared to QIV-SD among persons 65 years of age and older for the prevention of cardiovascular and/or respiratory hospitalizations.

Secondary Objective:

* To assess the clinical relative effectiveness of QIV-HD as compared to QIV-SD in prevention of:
* inpatient hospitalization for selected circulatory and respiratory causes
* death, either all-cause or cardiovascular or respiratory causes
* inpatient hospitalization (using primary and secondary discharge diagnoses)
* inpatient hospitalization (using admission diagnoses)
* hospital emergency room visits
* primary care visits to physician or
* major acute cardiovascular events (MACE)
* To assess the characteristics of inpatient hospitalization or hospital emergency room visits or primary care visits to physician by QIV-HD and QIV-SD groups.
* To describe the clinical relative effectiveness of QIV-HD as compared to QIV-SD:
* by age group and by group with specific comorbidities
* for different periods of observation
* To describe all serious adverse events (SAEs) (including adverse event of special interest \[AESIs\]) for all subjects in both QIV-HD and QIV-SD groups.

Study duration per participant was 1 day of screening and vaccination. The study was planned to be conducted over a period of 3 influenza seasons beginning in 2019-2020. The vaccination period was from October to December.

Eligibility Criteria:
Inclusion criteria:

- Aged 65 years or older on the day of inclusion ("65 years" means from the day of the 65th birthday).

Exclusion criteria:

* Participation at the time of study enrollment (or in the 4 weeks \[28 days\] preceding the study vaccination) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure.
* Previous vaccination against influenza (in the preceding 6 months) with either the study vaccines or another vaccine.
* Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the study or to a vaccine containing any of the same substances.

The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Study Evaluating The Mass Balance And Metabolic Disposition Of SKI-606

This study will assess the mass balance, metabolic disposition, and identification of metabolites following single oral administration of \[14C\]-SKI-606 in healthy male subjects.


Eligibility Criteria:
Healthy men, aged 18 to 50 years.
Exercise to Boost Response to Checkpoint Blockade Immunotherapy

The purpose of this pilot study will be to provide i) information on feasibility implementing an exercise intervention trial among patients with cutaneous cancers, including melanoma, squamous cell carcinoma (cuSCC), and Merkel cell carcinoma, scheduled to receive checkpoint blockade immunotherapy, and ii) preliminary data on the impact of a day-of-therapy exercise intervention.


Eligibility Criteria:
Inclusion Criteria:

1. Males and females ≥18 years of age.
2. Able to read and speak English fluently.
3. Reported ability to complete 20-30 minutes moderate exercise per positive response to, "Can you currently walk unaided for six minutes or more?"
4. Scheduled for first-time checkpoint blockade immunotherapy with avelumab, cemiplimab, ipilimumab, nivolumab, or pembrolizumab in the absence of other therapies (e.g. targeted therapy) with the following diagnosis:

   1. Adjuvant setting: cutaneous melanoma.
   2. Neoadjuvant setting: cutaneous melanoma, cuSCC, or Merkel cell carcinoma.
5. States willingness to follow protocol as described, including the prescribed exercise level and completing any forms needed throughout the study.
6. Voluntarily signed and dated an informed consent form, approved by an Institutional Review Board/Independent Ethics Committee, and provided Health Insurance Portability and Accountability Act authorization (HIPAA) or other privacy authorization prior to any participation in study.

   Exclusion Criteria:
7. Presence of medical conditions, such as severe cardiovascular disease for which exercise may be contraindicated. Participants may be referred to their medical team to obtain a cardiology approval.
8. Presence of major postoperative complications for which an exercise intervention may be contraindicated.
9. Currently has a chronic, contagious, infectious disease, such as active tuberculosis, active Hepatitis B or C, HIV, or COVID-19, per self-report.
10. Currently pregnant, lactating or planning to become pregnant (positive result on urine pregnancy testing).
11. Presence of any condition that, in the opinion of the Investigator, compromises participant safety or data integrity or the participant's ability to complete the study.
Exercise and Pain in CCS

The purpose of this study is to demonstrate that integration of exercise intervention into standard post-cancer directed treatment care will improve patient reported pain, decrease the need for medications to manage chronic pain and improve functional and psychosocial outcomes in survivors of cancers in children and adolescents. Our central hypothesis is that integration of exercise interventions into standard post-cancer directed treatment care will be acceptable and feasible while improving patients' pain, decreasing the cumulative dose of pain medication and improving patients' functional and psychosocial outcomes as compared to patients who only receive standard post-cancer directed treatment care.


Eligibility Criteria:
Inclusion Criteria:

1. Male and female CCS diagnosed with any type of cancer
2. CCS who have completed all standard/planned cancer treatment and are stable at the time of recruitment
3. CCS are \< 1-year post cancer therapy
4. CCS who have chronic pain (pain will be self-reported by the participant, will have to be ≥1 on a scale of 10 and lasting for 3 months or longer)
5. CCS who are age between 10 and 17 years old at the time of enrollment
6. CCS who are and who are not non-ambulatory/wheelchair bound.
7. CCS and parent/legal guardian must be able to speak, read and understand the English language
8. CCS's parent or legal guardian must be able to provide and understand informed consent
9. CCS must be able to provide and understand assent
10. CCS must be able to attend three visits (baseline, 8 and 16-week follow-up) at the Penn State Health Children's Hospital
11. CCS and parent/legal guardian must have access to a computer, smartphone or tablet

Note: The agreement of the attending oncologist will be required for the participation of CCS eligible for this study.

Exclusion Criteria:

1. CCS who have not completed all standard/planned cancer treatment and/or not in complete remission at the time of recruitment
2. CCS who are \> 1-year post cancer therapy
3. CCS who are \< 10 years old and \> 17 years old at the time of enrollment
4. CCS who have evidence in their medical record of an absolute contraindication to complete any of the physical assessments in their medical record. This exclusion criterion is at the oncologist's discretion when research staff will contact the medical oncologist via secure email or secure message through the electronic medical record for approval to approach their patients for the study and for medical clearance. The oncologists can update this information at any time during the study if there is evidence of an absolute contraindication to complete any of the physical assessments.
5. CCS who have history of refractory or recurrent cancer
6. CCS or their parent/legal guardian who are unable to speak, read, and understand the English language
7. CCS who are unable to access and complete online questionnaires
Study of Tumor Samples From Patients With Lung Cancer

RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This laboratory study is looking at tumor samples from patients with lung cancer.

OBJECTIVES:

Primary

* To determine the correlation between c-Met expression, mutation and amplification, with stage and overall survival in patients with adenocarcinoma (AC) of the lung.

Secondary

* To determine the correlation with epithelial mesenchymal transition (EMT), EGFR mutations and expression, Kras mutations, p53 mutations, c-CBL protein expression, mutation, loss of heterozygosity (LOH), DUB3 expression \& regulation, and ALK translocation, with respect to survival.
* To determine the correlation with circulating c-Met and HGF in AC and evaluate prognostic implications of circulating markers in AC of lung.
* To determine (when available) levels of circulating Met and HGF in serum before and after surgery.

OUTLINE: This is a multicenter study.

Previously collected tissue samples from patients enrolled in CALGB 140202 are assessed for mutation analysis of c-Met, EGFR, and K-ras. DNA is examined by PCR, followed by agarose gel electrophoresis; gene amplification of c-Met is examined by real time quantitative PCR; met/HF protein in serum is examined by ELISA; and c-Met, EGFR, p53, c-CBL, DUB3 enzyme, and ALK, and epithelial mesenchymal transition examined by IHC.

Eligibility Criteria:
Inclusion Criteria:

* Registration to Cancer and Leukemia Group B (CALGB) 140202
* Institutional Review Board (IRB) review and approval at the institution where the laboratory work will be performed is required
* Informed consent: the CALGB does not require that a separate consent form be signed for this study

  * The subject population to be studied in this protocol includes patients selected from CALGB 140202; all such patients have signed a written informed consent document meeting all federal, state, and institutional guidelines as part of entry into that trial
  * All samples to be studied were obtained and stored as part of CALGB 140202; the material and data obtained from the patient's protocol record will be used to obtain appropriate clinical information; in no instance will the patient be contacted directly
  * There should be no physical, psychological, social, or legal risks associated with this study; no invasive procedures are recommended or requested
  * All appropriate and necessary procedures will be utilized to maintain confidentiality; all patients who have had samples submitted for analysis will have their CALGB study number used to identify specimens
  * This study does not require direct patient contact and no specific risk or benefits to individuals involved in the trial are anticipated; it is likely, however, that the information gained will substantially help similar patients in the future