cyrilzakka/clinical-trials huggingface dataset:
Berlin PRehospital Or Usual Delivery of Acute Stroke Care 2.0 (B_PROUD 2.0)

Prehospital stroke care in specialized ambulances increases thrombolysis rates, reduces alarm-to-treatment times, and improves prehospital triage. Preliminary analyses suggest cost-effectiveness. However, scientific proof of improved functional outcome compared to usual care is still lacking. The objective of this trial is to show improved functional outcomes after deployment of a Stroke Emergency Mobile (STEMO) compared to regular care.

This is a pragmatic, prospective, multi-center trial with blinded outcome assessment of treatment candidates three months after stroke. Treatment candidates will be defined as patients with final discharge diagnosis of cerebral ischemia, and onset-to-alarm time ≤4 hours, disabling symptoms not resolved at time of ambulance arrival, and able to walk without assistance prior to emergency. These patients will be included if their emergency call from a predefined catchment area in Berlin, Germany, caused a stroke alarm at the dispatch center during STEMO hours (7am-11pm, Monday-Sunday). About 50% of STEMO dispatches will be handled by regular ambulances since STEMO will be already in operation creating the quasi-randomized control group.

Because of several organisational issues during the transition of the STEMO service into provisional regular care, the B_PROUD 1.0 evaluation has been defined as implementation study and will be complemented by the B_PROUD 2.0 study. B_PROUD 2.0. recruits patients with index event after May 1st, 2019.

B_PROUD uses data from the Berlin - SPecific Acute Treatment in ischemic and hemorrhagIc Stroke with longterm outcome (B-SPATIAL) registry. The B-SPATIAL registry started recruitment in January 2016.

Eligibility Criteria:
Inclusion Criteria:

1. Suspected acute stroke according to the dispatcher stroke identification algorithm during STEMO hours (7am-11pm, Monday-Sunday) and within the STEMO catchment area

   Inclusion criteria for primary study population:
2. Final diagnosis of ischemic stroke (ICD 10: I63) or TIA (Transient Ischemic Attack, ICD 10: G45 except G45.4)
3. Confirmed onset-to-alarm time ≤ 4 hours at dispatch
4. Pre-stroke modified Rankin scale ≤ 3 (being able to ambulate, in routine clinical care, patients with mRS up to 3 are usually deemed suitable for tissue plasminogen activator treatment)

Exclusion Criteria:

1. Remission of disabling symptoms until arrival of emergency medical service
2. Malignant or other severe primary disease with life expectancy \< 1 year

   Additional exclusion criteria for primary study population:
3. Major surgery within 4 weeks before study inclusion
4. Confirmed stroke within 3 months before study inclusion
5. Absolute contraindications for thrombolysis AND thrombectomy
Creating Homestead Agriculture for Nutrition and Gender Equity (CHANGE) in Burkina Faso

The purpose of this study is to assess the long-term impact of the Enhanced Homestead Food Production Program implemented by HKI on household food security and nutritional status, as well as the impact on including additional interventions (BCC on WASH and malaria prevention, distribution of preventive lipid-based nutrient supplements (LNS)) to children aged 6-24 months old, in addition to the standard E-HFP model.

Over the past twenty years, Helen Keller International (HKI) has implemented its Homestead Food Production (HFP) program to increase household production of micronutrient-rich foods and improve the quality of diets among vulnerable households across Asia and, more recently, Africa. As part of the program, village model farms -which support diversified, year-round production of micronutrient-rich crops, and improved breeds of poultry and small animals-are established to demonstrate gardening and small animal-raising techniques to program participants. Program participants in turn are established to demonstrate gardening and small animal-raising techniques to program participants. Program participants in turn are provided with small inputs such as seeds, seedlings, and small tools to establish home gardens using techniques they learn at the village model farms. In addition, the program uses a behavior change communication (BCC) strategy to increase participant's health and nutrition-related knowledge and practices.

In 2010, HKI introduced an enhanced-HFP (E-HFP) model in the Gourma province of Burkina Faso with support from the USAID. The project used a randomized cluster design to assess the impact of HKI's package of interventions on 1,200 beneficiary and 800 control children aged 3-12 months at baseline. Given the encouraging results of IFPRI's first evaluation of that project, HKI is working to continue to improve and evaluate its E-HFP program in Burkina Faso. Based on the recommendations from the initial evaluation in Burkina Faso, this research aims to assess both the long-term impact of the E-HFP program as well as the impact of including additional interventions, using the E-HFP platform to deliver these interventions. The primary research questions that will be addresses will be:

* What is the relative impact of a long-term E-HFP program compared to a short-term E-HFP program on household food security and child nutritional status?
* What is the impact of including additional messages and the promotion of practices related to water, sanitation, hygiene, and malaria prevention (including bednet utilization) in the BCC strategy, in addition to the standard E-HFP model?
* What is the impact of distributing preventive lipid-based nutrient supplements (LNS) to children between the ages of 6-24 months in addition to participation in the E-HFP program + additional messages and the promotion of practices related to water, sanitation, hygiene, and malaria prevention (including bednet utilization)?

Eligibility Criteria:
Inclusion Criteria:

* Mother of child between the ages of 0 and 12 months and her child

Exclusion Criteria:

* N/A
REACH Detroit Partnership Family Intervention

The objectives of the proposed study are to determine whether culturally diverse community residents with diabetes are willing to participate in our community health worker intervention using randomized controlled trial (RCT) methods and to explore and document effective processes and protocols for RCT methods in these communities. The investigators will examine retention rates, identify reasons for attrition through interviews and focus groups, and determine strategies for improving recruitment, retention, and intervention methods. As a secondary objective, the investigators will explore the potential impacts of the intervention for improving healthy lifestyles, diabetes self-management, and selected health outcomes of participants.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Had physician-diagnosed type 2 diabetes
* Self-identified as African American or Latino/Hispanic
* Lived in the targeted zip codes.

Exclusion Criteria:

* Individuals who already had serious diabetes-related complications, such as blindness, amputated limbs, and kidney failure
Universal Screening for Vocal Fold Motion Impairment in Children Undergoing Congenital Cardiac Surgery

The purpose of this study is to determine how often heart or chest surgery in children leads to problems with the movement of the vocal folds.

Pediatric vocal fold motion impairment (VFMI) is a well-known cause of dysphonia and dysphagia. Previous studies have demonstrated the most common etiology for pediatric VFMI is cardiothoracic surgery which is possibly due to a variety of mechanisms.The investigators hypothesize that universal screening of neonates for VMFI following congenital cardiac surgery (CCS) will lead to a more accurate incidence and earlier diagnosis of VFMI. They believe that earlier identification will lead to changes in feeding regimens that may decrease length of stay (LOS), decrease time to oral feeding, earlier otolaryngologic intervention if indicated, and decreased rates of readmission for pulmonary or feeding complications. The investigators will also use this information to design a refined algorithm for targeted screening of patients who are more likely to have VFMI based on patient and surgery characteristics.

Eligibility Criteria:
Inclusion Criteria:

* Children 18 and younger with congenital cardiac disease necessitating surgery
* Children 18 and younger whose parents have given and signed an informed consent and HIPAA Authorization as well as the assent of the patient

Exclusion Criteria:

* History of prior cardiac surgery
* Known history of VFMI prior to evaluation
* Children 18 and younger who do not survive the immediate postoperative course will be excluded.
* Further exclusion may be determined at the discretion of the Principal Investigator.
Differential Expression and Analysis of Peripheral Plasma Exosome miRNA in Patients With Myocardial Infarction

The aim of this study is to determine the miRNA expression profile in peripheral blood exosomes of patients with myocardial infarction and to investigate its relationship with myocardial infarction.

Collect exosomes in peripheral blood of patients with myocardial infarction, compare the expression of miRNA with healthy volunteers, find out the miRNAs with significant differences, and explore its relationship with the development of myocardial infarction.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years ST elevation by ECG diagnostic of STEMI Evidency of coronary occlusion in coronariography Signed informed consent

Exclusion Criteria:

* Patients who will undergo immediate PCI Pregnant and lactating women Patients with mental disorders Patients are using other experimental drugs; Refusal to provide informed.
A Study of Overall Survival in Participants With Unresectable Hepatocellular Carcinoma

The primary purpose of this study to continue follow-up of participants enrolled in the study E7080-M081-504 (NCT03663114) of lenvima capsules and to evaluate the overall survival of participants with hepatocellular carcinoma.


Eligibility Criteria:
Inclusion Criteria:

- All participants enrolled in the study E7080-M081-504 with informed consent to participate in this study.

Exclusion Criteria:

* Participants who do not have unresectable hepatocellular carcinoma
* Participants who have not given informed consent or have withdrawn consent to participation
* Participants with a history of hypersensitivity to any ingredient of lenvima
* Pregnant or possibly pregnant women
* Participants previously treated with lenvima (excluding those previously enrolled in the Study E7080-M081-504 \[NCT03663114\] at another clinical site).
Safety and Efficacy of iDose® TR With Cataract Surgery vs. Cataract Surgery Alone

This trial will evaluate the safety and IOP -lowering efficacy of administering an iDose TR (travoprost intracameral implant) in conjunction with cataract surgery compared to cataract surgery alone

This is a Phase 4 randomized, double-masked, parallel group trial designed to evaluate the safety and IOP-lowering efficacy of administering iDose TR (travoprost intracameral implant 75 mcg) in conjunction with uncomplicated cataract surgery (phacoemulsification with a posterior chamber intraocular lens) compared to uncomplicated cataract surgery alone, in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).

Eligibility Criteria:
Inclusion Criteria:

* Cataract diagnosis: clinically significant age-related cataract eligible for phacoemulsification in the study eye.
* OAG or OHT diagnosis: either OAG (i.e. primary, pseudoexfoliation, or pigmentary glaucoma) or OHT in the study eye (i.e., eye to undergo cataract surgery)

Exclusion Criteria:

* Active corneal inflammation or edema.
* Retinal disorders not associated with glaucoma.
Supplemental Study to Evaluate the Safety and Effectiveness of the NovaCross™ Micro-catheter

This study will include up to 60 eligible male and female subjects. The purpose of this trial is to evaluate the safety and effectiveness of the NovaCross™ micro-catheter when used to facilitate crossing of Chronic Total Occlusion (CTO) lesions in coronary arteries. The procedure will be conducted on consenting patients diagnosed with a CTO in a coronary vessel that requires revascularization after a previously failed attempt to cross or refractory to 10 minutes of conventional guidewire attempt. This study is an extension study of Nitiloop's Pivotal study.

The purpose of this trial is to evaluate the safety and effectiveness of the NovaCross™ micro-catheter when used to facilitate crossing of Chronic Total Occlusion (CTO) lesions in coronary arteries. The procedure will be conducted on consenting patients diagnosed with a CTO in a coronary vessel that requires revascularization after a previously failed attempt to cross or refractory to 10 minutes of conventional guidewire attempt.

Eligibility Criteria:
Inclusion Criteria:

1. Adult aged 25-80
2. Patient understands and has signed the study informed consent form
3. Patient has an angiographic documented Chronic Total Occlusion (i.e. \>3 months occlusion duration) showing distal TIMI flow 0, with a reference diameter of at least 2 millimeters.
4. Left ventricle ejection fraction \> 25%

Exclusion Criteria:

1. Patient unable to give informed consent. 2. Elevated CK-MB or troponin at baseline 3. Patient is known or suspected not to tolerate the contrast agent 4. Chronic Total Occlusion is located in aorto-ostial location, SVG CTO, in-stent occlusion 5. Appearance of a fresh thrombus or intraluminal filling defects 6. Intolerance to Aspirin and/or inability to tolerate a second antiplatelet agent (Clopidogrel and Prasugrel and Ticagrelor) 7. Cardiac intervention within 4 weeks of the procedure 8. Severe renal insufficiency with eGFR\<30 ml/min/1.72 m2 9. Congestive heart failure \[New York Heart Association (NYHA) Class III\\IV\] CSA Class IV 10. Life expectancy \< 2 years due to other illnesses 11. Acute or unstable medical disorder/disease that may cause a risk to patient, including: i. Recent myocardial infarction (MI) (within the past two weeks) ii. Significant anemia (e.g. hemoglobin \< 8.0 mg / dl) iii. Recent major cerebrovascular event (history of stroke or TIA within 1 month) iv. Severe uncontrolled systemic hypertension (e.g., \>180/100 mmHg) v. Unstable angina requiring emergent percutaneous trans-luminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG)
Vaccine Therapy in Treating Patients With Metastatic or Recurrent Cancer

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.

PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who have metastatic or recurrent cancer.

OBJECTIVES: I. Determine the optimum biologic dose of MVF-HER-2(628-647)-CRL 1005 vaccine that will induce anti-HER-2 antibody in patients with metastatic or recurrent cancer. II. Characterize the nature and severity of toxicity of this drug in these patients. III. Document any clinical responses to this drug in these patients.

OUTLINE: This is a dose-escalation study. Patients receive MVF-HER-2(628-647)-CRL 1005 vaccine intramuscularly on days 1 and 29. Cohorts of 5 patients receive escalating doses of MVF-HER-2(627-647)-CRL 1005 vaccine until at least 2 of 5 patients experience dose-limiting toxicity. Patients are followed on days 43 and 57 and every 2 months for at least 1 year.

PROJECTED ACCRUAL: Approximately 5-25 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed metastatic and/or recurrent solid tumor, especially the following: Breast Ovarian Non-small cell lung cancer Gastric adenocarcinoma No standard therapy available No brain metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 3,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL ALT less than 2 times upper limit of normal No hepatitis A, B, or C Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance greater than 60 mL/min Cardiovascular: No serious cardiopulmonary disorder No congestive heart failure No symptomatic coronary artery disease No serious cardiac arrhythmia Pulmonary: No serious cardiopulmonary disorder No symptomatic chronic obstructive pulmonary disease Immunologic: Reactive to at least 1 of the following skin test antigens: Candida, mumps, Trichophyton, intermediate strength PPD, tetanus toxoid No concurrent disease requiring corticosteroids or other immunosuppressive drugs No autoimmune disease, including rheumatoid arthritis, systemic lupus erythematosus, scleroderma, polymyositis-dermatomyositis, or vasculitic syndrome No prior anaphylactic response to other vaccine No hypersensitivity to MVF-HER-2(628-647) Other: No active HIV No active infection requiring antibiotic therapy No serious medical disease Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy and recovered Chemotherapy: At least 4 weeks since prior cytotoxic chemotherapy and recovered Endocrine therapy: At least 4 weeks since prior hormonal therapy and recovered No concurrent corticosteroids Radiotherapy: At least 4 weeks since prior radiotherapy and recovered Surgery: At least 4 weeks since prior surgery and recovered No prior splenectomy
Use of Adjustable Gastric Band in Adolescents

This study is to investigate the use the adjustable gastric band for the treatment of obesity in adolescents.

Weight loss is related to the amount of energy or fuel obtained from the kinds and amounts of food eaten. When the amount of exercise and dieting uses less fuel than the amount taken in, the excess is stored as fat. The Adjustable Gastric Band used in this study is a tool to help the participant loose weight along with healthy eating, diet and exercise. This study involves minimally invasive laparoscopic surgery to place the adjustable band around the upper part of the stomach to make a smaller stomach or pouch about the size of a golf ball. One end of the band ends with a flat balloon that goes around the upper part of the stomach. The opening from this small stomach can be changed to allow more or less food into the intestine depending on the amount eaten and the amount of weight lost.

The other end of the of the band ends in a filling port through which saline solution is pumped with a needle through an attached tube to inflate or deflate the balloon. The filling port is attached to the wall of the abdomen under the skin. Because the flow of food is regulated by the band, most people feel full faster. This is how the appetite for food is controlled and the why the person is likely to eat less with the band in place.

Food is digested through the normal digestive process.

Eligibility Criteria:
Inclusion Criteria:

BMI: Female: ≥ 27 - ≥ 33 Male ≥ 26 - ≥ 30.5

Exclusion Criteria:

* •Hypertension: Systolic blood pressure (SBP) of 140 mm Hg

  * Hyperlipidemia: hyperlipidemia depends on
  * Obstructive Sleep Apnea:
  * Metabolic Syndrom: The presence of any three of the following: abdominal obesity - dimensons for children? triglycerides -cholesterol -
* fasting glucose
* blood pressure

  * overweight
  * Non-surgical means of weight reduction failure of
  * Significant psychopathology (absence of ) that could limit the subject's ability to understand the procedure, comply with medical, surgical, and/or behavioral recommendations, as documented during screening assessment;
  * Agrees to refrain from any type of reconstructive surgery that would affect body weight such as abdominal lipoplasty or liposuction, mammoplasty, or removal of excess skin for three years following SAGB placement; and
  * Candidate for surgical weight loss intervention (i.e., meets accepted health criteria for major surgery.
Contribution of Learning and Practice of Different Complementary Therapies in Pulmonary Transplant Patients

The aim of the study is to evaluate, 3 months after lung transplantation, integration and appropriation by the patient of complementary techniques (" Toolbox " included relaxation, autohypnosis, relaxation therapy, TENS (if pain) and holistic gymnastics to improve the comfort and the quality of life in very high-technology care pathway

Patients approaching a lung transplant will face specific infectious, immunological, ventilatory and hemodynamic problems but also to painful, stressful and anxiety-provoking situations. Learning different complementary therapies in the pre-transplant period allows patients to have personal tools to improve their comfort before and after the transplant. These tools can be used by patients who have acute or chronic pain symptoms, to support painful examination or care, and for situations of stress and anxiety.

The project aims to present different therapies complementary to patients. Before and after transplant, patients benefits of learning and realization sessions of these techniques. They appropriate the techniques and choose the ones that suit best.

The overall benefit will be judged comparing period before transplant to period after transplant on different criteria.

Eligibility Criteria:
Inclusion Criteria:

* Candidates for a lung transplantation benefiting from a pre-transplant evaluation

Exclusion Criteria:

* transplant patient in emergency
* delay between pre-transplant evaluation and transplantation over 12 months