cyrilzakka/clinical-trials huggingface dataset:
Safety and Preliminary Efficacy Study of an Anti-inflammatory Therapeutic Antibody in Reducing Restenosis.

The purpose of this study is to determine if CV-18C3 will reduce the rate of restenosis or the time to restenosis in patients undergoing repeat peripheral artery revascularization versus controls randomized to standard of care.

Restenosis of peripheral artery lesions remains a challenging problem to overcome after percutaneous revascularization of atherosclerotic disease in the femoropopliteal arterial system. Rates of restenosis are as high as 60% after a year. Treatment options include medical therapy, angioplasty, arthrectomy and stent placement. The heterogeneity of disease between patients, variable length of target lesions and presence of unpredictable physical forces requires individualized treatment plans.

Vascular response to injury appears to play an important role in the development of restenosis. IL-1α is a potent inflammatory cytokine that plays a central role in vascular inflammation and vascular smooth muscle proliferation--both in acute and chronic injury. CV-18C3 antagonizes the biologic activity of IL-1α and is theorized to prevent the early IL-1α mediated inflammation that leads to vascular smooth muscle hypertrophy and restenosis, as well as the late IL-1α mediated atherosclerotic plaque formation.

Eligibility Criteria:
Inclusion Criteria:

* Have suspected superficial femoro-popliteal artery occlusion due to lower extremity pain with exercise or at rest and are undergoing a planned arteriogram.
* Subjects will be randomized after angiographic evidence of qualifying lesion

Exclusion Criteria:

* Acute critical limb ischemia
* History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
* Any surgical or medical condition, which in the opinion of the investigator, may place the patient at higher risk from his/her participation in the study, or is likely to prevent the patient from complying with the requirements of the study or completing the study.
Abortive Treatment of Migraine With the Cefaly® Abortive Program Device

The purpose of this study is to investigate the efficacy of the Cefaly® Abortive Program device used at home for 2 hours to treat a migraine attack. This open clinical trial will study the abortive treatment of migraine using the Cefaly® Abortive Program device, prior to development of a sham-controlled trial.

The main objective of this study is to have a pilot assessment of the efficacy of the Cefaly® Abortive Program device used at home for 2 hours to treat a migraine attack, as triptans are generally used. That is to say having pilot data to assess the efficacy of the Cefaly® Abortive Program device in the abortive treatment of acute migraine as measured by 2-hour pain freedom, pain relief and migraine associated symptoms freedom, plus evolution of these measurements for 24 hours after the beginning of the treatment session.

Eligibility Criteria:
Inclusion Criteria:

* Age from 18 to 65 years on the day of signing the informed consent form
* ≥ 1-year history of migraine with or without aura according to the diagnostic criteria listed in the International Classification of Headache Disorders (ICHD)-III beta (2013) section 1, migraine (8), with the exception of aura without headache, hemiplegic migraine and brainstem aura migraine
* Migraine onset before the age of 50 years
* Having between 2 and 8 moderate or severe migraine attacks (Grade 2 or 3) per month in each of the two months prior to screening
* Patient understands the study procedures, alternative treatments available, and voluntarily agrees to participate in the study by giving written informed consent
* Patient is able to read and understand the written information (instruction sheet, paper diary and Adverse Events (AE) collecting form)

Exclusion Criteria:

* Patient has difficulty distinguishing his/her migraine attacks from tension-type headaches
* Patient has more than 15 headache days per month
* Patient having received supraorbital nerve blocks in the prior 4 months
* Patient having received Botox treatment in the prior 4 months
* Modification of a migraine prophylaxis treatment in the previous 3 months
* Diagnosis of other primary headache disorders, except rare (\< 4) tension-type headaches per month
* Diagnosis of secondary headache disorders included Medication Overuse Headache
* Patients abusing opioids or user of recreational or illicit drugs or has had a recent history (within the last year) of drug or alcohol abuse or dependence
* Implanted metallic or electronic device in the head
* Cardiac pacemaker or implanted or wearable defibrillator
* Patient having had a previous experience with the Cefaly® device
* Migraine Aura without headache
* Patient is currently participating or has participated in a study with an investigational compound or device within 30 days of screening visit (Visit 1)
* Patients not having the ability to use appropriately the device and/or to perform themselves or bear the first 20-minute stimulation session during the training session at the study site
Metabolism and Oxygen Consumption During Functional Electrical Stimulation Cycling in COPD

Chronic Obstructive Pulmonary Disease (COPD) had systemic repercussion and lead to peripheral muscular dysfunction. Muscular atrophy limits aerobic capacity and is a major limitation of daily activity and quality of life. Technologies likes' neuromuscular electrical stimulation (NMES) are currently being adapted and tested to support exercise training.

The investigators hypothesized that functional electrical stimulation cycling improves VO2 and aerobic capacities during exercise compared to endurance training.


Eligibility Criteria:
Inclusion Criteria:

* COPD (Stade II, III or IV)
* Inform consent

Exclusion Criteria:

* Pulmonary rehabilitation contraindication
* Patient with Pacemaker
* Patient in acute exacerbation
* Patient with neurologic comorbidity
* Anemiae
Effect of Lithium Carbonate on Postoperative Sleep and Cognitive Function in Patients Undergoing Heart Valve Surgery With Cardiopulmonary Bypass

It has been proved that lithium carbonate can prolong slow wave sleep with few or no side-effects. The aim of the present study is to evaluate postoperative sleep quality of patients undergoing heart valve surgery with cardiopulmonary bypass taken 250mg lithium carbonate after surgery.

This study is a prospective, randomized, controlled (randomized, parallel group, concealed allocation), double-blinded trial. All patients undergoing heart valve surgery with cardiopulmonary bypass will be randomized 1:1 to the treatment intervention with lithium carbonate 250mg (Baoqing, Hunan, China) or calcium carbonate 500mg (Reneed, Beijing, China) after surgery. The objective of the trial is to evaluate the lithium carbonate 250mg on the postoperative night sleep quality. Duration of sleep was collected with polysomnography on second postoperative night. (from 20:00pm to 06:00. Mini-Mental State Examination (MMSE) score was performed on the seventh postoperative day

Eligibility Criteria:
Inclusion Criteria:

* Ethnic Chinese;
* Age, 18 to 65 years old;
* Patients undergoing heart valve surgery with cardiopulmonary bypass

Exclusion Criteria:

* Preoperative Pittsburgh Sleep Quality Index global scores higher than 6
* Cognitive difficulties
* Partial or complete gastrectomy
* Previous esophageal surgery
* Previous treated by radiotherapy or surgery
* Inability to conform to the study's requirements
* Body mass index exceeding 30 kg/m2
* Deprivation of a right to decide by an administrative or juridical entity
* Ongoing participation or participation in another study \<1 month ago
* Recent (\< 3 months prior) use of antibiotics, probiotics, prebiotics, symbiotics, hormonal medication, laxatives, proton pump inhibitors, insulin sensitizers or traditional Chinese medicine
Immunotherapy & Me

Immunotherapy \& Me is a pilot study to determine patient and provider needs around immunotherapy treatment, and to determine the most meaningful resources to improve patient outcomes and decrease cost. Specifically, this study aims:

1. To determine whether layering in customizable resources at the point-of-care that offer healthcare providers care-management tools to give their immunotherapy patients leads to changes in (a) patients' knowledge, attitudes, and health behaviors (including self-reported measures of self-efficacy and empowerment, cancer-related distress, quality of life, and satisfaction with the programs offered) and (b) improved clinical outcomes (including decreased hospital admissions, decreased hospital readmissions, and decreased costs associated with hospitalizations).
2. To successfully integrate the Immunotherapy \& Me program within oncology practices to provide a model framework for dissemination across other care providers. Once success is demonstrated, a turn-key model of immunotherapy patient support can be expanded to other oncology care systems.

As usage and indications for immunotherapy increase, there presents a critical need to identify patient-centered and practice solutions across the continuum of care. Immunotherapy \& Me is an innovative program of customizable resources that seeks to improve the patient experience by supporting the unique needs of both immunotherapy patients and the clinical staff who care for them. The Cancer Support Community (CSC) will implement this operational framework of patient and provider tools at multiple geographically and demographically diverse oncology practices.

The program will include CancerSupportSource® (CSS), a self-administered screening instrument for individuals with cancer that takes approximately 10 minutes to complete and has been validated in 300 English-speaking cancer survivors at CSC affiliates nationwide.The instrument consists of cancer-related problems (physical, social, psychological, emotional and practical) and has been demonstrated to have good internal consistency reliability. Patients are asked to rate the severity of their concerns and if they would like to talk with a staff person and/or receive additional information about their concerns. This information is used to address immediate concerns as well as to develop ongoing educational experiences that are tailored and integrated with their care.

At the end of year one, CSC will evaluate program impact, retool interventions as necessary, and pursue additional funding with the goal of extending services at existing practice sites - and scaling this turnkey model of immunotherapy treatment support.

Eligibility Criteria:
Inclusion Criteria:

* Receiving immunotherapy as a cancer treatment at a participating pilot site location
* English- or Spanish-speaking, or having access to a translator

Exclusion Criteria:

-
A Study of Supaglutide in Chinese Type 2 Diabetes Patients

A study on the safety, efficacy, pharmacokinetics and pharmacodynamics of Supaglutide dosing weekly and bi-weekly in patients with type 2 diabetes mellitus.


Eligibility Criteria:
Inclusion Criteria:

1. Have diagnosed with type 2 diabetes for at least 3 months before enrollment.
2. Have diet and exercise intervention only (for part A and part B) or been treated with stable dose of metformin as monotherapy for at least 3 months (for part B only)
3. Have HbA1c ≥7.0% and ≤10.0% as assessed by the central laboratory.
4. Have a body mass index (BMI) of 20-40 kilograms per square meter (kg/m\^2).

Exclusion Criteria:

1. Type 1 diabetes (T1D).
2. Evidences of fasting C-peptide levels\<0.81 ng/mL.
3. History of trauma, infection or surgery within a month;
4. History of blood donation, blood transfusion or losing more than 450 ml blood within 3 months.
5. History of the severe cardiovascular conditions, gastrointestinal diseases, blood system diseases, pancreatitis, or malignant tumors.
6. Evidence of abnormal thyroid function within 6 months before screening.
7. Positive test results in HBsAg, HCVAB, HIVAB or TPAB.
8. History of serious mental illness.
9. History of drug or alcohol abuse.
10. History of a transplanted organ, acquired or congenital immune system diseases.
11. Allergy to active ingredients or excipients of the test drug.
12. Evidence of abnormal result of laboratory examination according to the judgment of researchers.
13. Participated in any interventional medical, surgical, or pharmaceutical study within 3 months prior to entry into the study.
14. Previously completed or withdrawn from this study after providing informed consent.
SGI-110 in Combination With Carboplatin in Ovarian Cancer

A 2-part, Phase 2 controlled, open-label, randomized study in participants with platinum-resistant recurrent ovarian cancer. In Part 1, participants received SGI-110 and carboplatin. The optimum dose of SGI-110 (guadecitabine) was identified in Part 1 based on safety and efficacy. In Part 2, participants were randomized to receive the dose identified in Part 1 plus carboplatin or one of four treatment of choice at the discretion of the investigator. The treatment of choice consisted of topotecan, pegylated liposomal doxorubicin, paclitaxel or gemcitabine.


Eligibility Criteria:
Inclusion Criteria:

1. Participants who are women 18 years of age or older.
2. Participants who have histologically or cytologically confirmed recurrent high-grade serous epithelial ovarian cancer (Grade 2 or 3), primary peritoneal carcinomatosis or fallopian tube cancer.
3. Participants who have platinum-resistant disease (defined as having relapsed within 6 months of her last platinum-containing regimen). There is no limit on the number of prior treatment regimens in Part 1. In Part 2, participants may have had no more than 3 prior cytotoxic treatment regimens, excluding adjuvant or maintenance therapy.
4. Participants must have had prior paclitaxel treatment.
5. Participants who have measurable disease according to RECIST v1.1 or detectable disease.
6. Participants with ECOG performance status of 0 or 1.
7. Participants with acceptable organ function.
8. Participants must be at least 3 weeks from last chemotherapy.

Exclusion Criteria:

1. Participants who have hypersensitivity to SGI-110 and/or carboplatin or other components of these drug products.
2. Participants who have received prior therapy with any hypomethylating agents.
3. Participants who are refractory to platinum treatment i.e., progressed while on platinum treatment.
4. Participants with abnormal left ventricular ejection fraction.
5. Participants with Grade 2 or greater neuropathy.
6. Participants with known brain metastases.
7. Participants with known history of HIV, HCV or HBV.
Hemodynamic and Respiratory Variations During Laparoscopic Surgery With and Without Deep Neuromuscular Blockade.

The goal of this study is to investigate the effect of depth of neuromuscular block (NMB) on global and regional (dependent versus nondependent) respiratory mechanics during laparoscopic surgery. Furthermore, we will investigate if the level of NMB influences intraoperative hemodynamic and cerebral oxygenation.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Elective patients scheduled to undergo laparoscopic surgery with expected duration \> 2h
* Physical status ASA I - III

Exclusion Criteria:

* Pregnancy
* Severe cardiac disease (NYHA class III or IV, acute coronary syndrome, or persistent ventricular tachyarrhythmia)
* Previous lung surgery
* History of severe chronic obstructive pulmonary disease
* Gastro-esophageal pathology (including but not limited to recent gastric or esophageal surgery including bypass/banding, history of esophageal varices, known anatomical gastric or esophageal defects such as strictures, hernias or fistulas)
* Mechanical ventilation within the last 30 days
* Neuromuscular disease
* Consented for another interventional study or refusal to participate in the present study
* Hypersensitivity (e.g., anaphylaxis) to rocuronium bromide or other neuromuscular blocking agents
The Effect of Eggs on Postprandial Metabolism

The objective of this randomized, double-blinded, placebo-controlled, 3-way crossover pilot study is to determine whether eggs can favorably alter biomarkers of postprandial metabolism when included with other cooked breakfast foods typically selected by older Americans.


Eligibility Criteria:
Inclusion Criteria:

* Men \& postmenopausal women, aged 50-70 years
* BMI 28-34 kg/m2

Exclusion Criteria:

* Cigarette smoking and/or nicotine replacement use
* Individuals taking estrogen
* Use of cholesterol-lowering medications
* Use of blood pressure-lowering medications
* Regular use of any stomach acid-lowering medications or laxatives (including fiber supplements)
* Cardiovascular (heart) disease
* Gastrointestinal disease
* Kidney disease
* Endocrine disease: including diabetes, untreated thyroid disease
* Rheumatoid arthritis
* Active treatment for any type of cancer, except basal cell carcinoma, within 1 year prior to study admission
* Systolic blood pressure \> 150 mmHg and/or diastolic blood pressure \> 95 mmHg
* Regular use of oral steroids
* Regular daily intake of ≥ 2 alcoholic drinks
* Vegetarians
* Allergy to eggs
* Avoidance and/or intolerance of pork products
* No dietary supplements, including those containing any vitamins, minerals,herbs, plant concentrates (including garlic, gingko, St. John's wort) homeopathic remedies, probiotics, or fish oil (including cod liver oil), for one month prior to study admission
Physiological Demands Related to Exercises in Singing for Lung Health

This study will assess the physiological demands related to Singing for Lung Health participation.

This study will assess the physiological demands experienced by healthy volunteers participating in components of a Singing for Lung Health session. Oxygen consumption, heart rate, and fixed body sensor output puts related to balance and movement intensity will be assessed. The same parameters will also be assessed during walking on a treadmill at different speeds for comparison.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adult
* Able to undertake singing components
* Able to undertake walking test
* No contraindications to exercise
* No contraindications to spirometry as per American Thoracic Society/European Respiratory Society criteria
* Capacity to consent to exercise testing.

Exclusion Criteria:

* Any health condition that would preclude them from singing or impede physical activity
* Inability to comply or follow singing exercise instructions
* Active musculoskeletal disease impairing exercise.
Icotinib as Consolidation Therapy After Chemoradiotherapy in EGFR-Mutant Stage IIIA-IIIB Non-small Cell Lung Cancer

The main purpose of this study is to evaluate the relapse free survival of patients who have EGFR-mutant stage IIIA-IIIB Non-small Cell Lung Cancer and receive Icotinib as consolidation therapy after synchronous or sequential chemoradiotherapy.

This is a single center, single arm, open label and prospective clinical study. Patients who have EGFR-mutant stage IIIA-IIIB and unresectable lung adenocarcinoma will receive Icotinib as consolidation therapy after synchronous or sequential chemoradiotherapy. The primary objective of this study is relapse free survival. The secondary objectives are overall survival, the frequency of adverse events and patients' quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Unresectable stage IIIA-IIIB Non-small Cell Lung Cancer, histology or cytology confirmed lung adenocarcinoma, pathological specimens with EGFR 19 del and/or 21 L858R gene mutation detected by amplification refractory mutation system method
* Before receiving synchronous or sequential chemoradiotherapy, no metastasis detected by head MRI, bone scan, chest enhanced CT scan and the abdominal (including dual adrenal) enhanced CT scan
* Only received synchronous or sequential chemoradiotherapy as anti-tumor treatment; after that, chest enhanced CT showed no progressive disease (including Complete Response, Partial Response and Stable Disease )
* Platinum-based chemotherapy regimen, including: vinorelbine, docetaxel, paclitaxel, pemetrexed, etoposide, etc and combination of platinum (including but not limited to cisplatin and carboplatin)
* 3DCRT or IMRT radiotherapy technology with a dose of 95% PTV 60-66gy, 2Gy once daily, 5 times weekly, up to 30-33 times
* ECOG score 0-1
* Able to enter the group within 4-12 weeks after the completion of synchronous or sequential chemoradiotherapy
* Expected survival more than 12 weeks

Exclusion Criteria:

* Other malignant tumors within five years, except for completely cured cervical carcinoma, basal or squamous cell carcinoma
* In addition to synchronous or sequential chemoradiotherapy, ever received other systemic anti-tumor treatment, including chemotherapy or targeted therapy
* Any unstable systemic disease, including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, liver, kidney or metabolic disease
* Upper vena cava syndrome at baseline
* Idiopathic pulmonary fibrosis detected by CT at baseline
* Definite neurological or psychiatric disorders, including epilepsy or dementia
* Pregnant or lactating women
A Study of Aripiprazole Lauroxil in Subjects With Schizophrenia or Schizoaffective Disorder

The study will determine the safety, tolerability, and pharmacokinetics of aripiprazole lauroxil in adults with schizophrenia or schizoaffective disorder.


Eligibility Criteria:
Inclusion Criteria:

* Has a diagnosis of chronic schizophrenia or schizoaffective disorder
* Has demonstrated ability to tolerate aripiprazole
* Has been on a stable antipsychotic medication regimen without any changes for at least 2 months prior to screening
* Has a body mass index (BMI) of 18.0 to 40.0 kg/m2, inclusive
* Additional criteria may apply

Exclusion Criteria:

* Is pregnant, is planning to become pregnant, or is currently breastfeeding
* Has received aripiprazole lauroxil or IM depot aripiprazole within 6 months, or other long-acting, injectable antipsychotic medication within 3 months or currently treated with clozapine
* Is a danger to himself/herself at screening or upon admission
* Has a history of or positive test result for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
* Has a positive urine drug screen at screening or Day 1
* Additional criteria may apply
Anti-obesity Effects of Dandelion (Taraxacum Officinale L.)

The study investigates the effectiveness of the natural product Dandelion in treating obesity in premenopausal women through a randomized interventional trial, measuring various parameters and biomarkers.

The study aims to explore the anti-obesity effects of dandelion supplementation in premenopausal obese women. The research will measure changes in appetite, energy intake, body weight, composition, lipid profile, and inflammatory markers, providing evidence of dandelion\&#39;s efficacy as an anti-obesity phototherapy. The randomized interventional trial will measure multiple parameters and biomarkers.

Eligibility Criteria:
Inclusion Criteria:

Premenopausal women with obesity. Age between 18-45 years Stable body weight in the past 3 months

Exclusion Criteria:

Pregnancy Breastfeeding Diabetes Cardiovascular diseases kidney or liver diseases use of medications that affect body weight Smoking Allergy to dandelion or related plants