cyrilzakka/clinical-trials huggingface dataset:
Connect to Protect (C2P): Building a Community-Based Infrastructure for HIV Prevention

The proposed study seeks to continue the implementation of Connect to Protect® (C2P), a community mobilization intervention, which entails developing coalitions to plan for and bring about structural changes for purposes of reducing HIV incidence and prevalence among youth in targeted communities at five ATN sites.

The C2P community mobilization model entails: determining a geographic area and population of focus for the coalitions to prioritize their planning and action; developing coalitions that have a shared vision and mission; developing a strategic plan focused on structural changes to reduce risks associated with HIV; documenting processes; providing feedback as technical assistance to the coalitions; hosting regular working group meetings; and on-going capacity building. The National Coordinating Center (NCC), operating under the direction of the Protocol Chair, provides guidance, training, technical assistance and feedback to coalitions.

The evaluation of C2P includes both process evaluation (i.e., documentation of coalition actions and achievements of structural changes; and outcome evaluation to qualitatively assess (via Key Informant (KI) interviews) if and how C2P efforts, including completed structural changes, have influenced the risk environment within each community. In addition, local health surveillance data and HIV testing data will be used to evaluate changes in HIV testing patterns and HIV/Sexually Transmitted Infection (STI) morbidity among youth.

Eligibility Criteria:
1. The intervention group = Community members who become engaged in the coalitions and in the broader mobilization effort; and
2. The evaluation group = Key Informants within each C2P community who either work or reside within the sectors or systems where structural changes have been accomplished and/or the coalition has focused their strategic planning efforts.
A Study on Telemedicine Applied to Actual Outpatient Clinic for Epilepsy

This is an observational study to confirm the non-inferior effectiveness on health outcomes of tele-counseling or tele-prescription, which was the first outpatient system applied to the actual medical sites in Korea during the coronavirus disease 2019 (COVID-19) pandemic. Researchers collect data using electronic medical records and questionnaires to patients and their caregivers who are continuously receiving outpatient treatment for epilepsy at a single center. The results of the study will be presented by comparing the health outcomes between the non-face-to-face care group and the usual care group.

During the COVID-19 pandemic, temporary phone consultations or prescriptions are being conducted at actual medical sites in Korea. Now, interest about non-face-to-face medical care and expectation that this medical service will be available in the post COVID-19 era are increasing.

The aim to study non-inferior effectiveness of health outcomes for epilepsy by comparing non-face-to-face care with usual care. In this observational study, two groups are recruited in a matched pair parallel in 1:2 allocation at single outpatient clinic. And then investigators collect data such as seizure control, adherence to treatment, adverse drugs reactions by using electronic medical records and questionnaires.

Because epilepsy, the target disease of the study, has chronic and recurrent symptoms, it is necessary for patients to visit the hospital regularly to check their condition. However, there are few neurologists in the province who can treat epilepsy. So that Patients and their caregivers spend a lot of time and money traveling long distances to get treatment.

Eligibility Criteria:
Inclusion Criteria:

* Those who have received outpatient treatment for epilepsy at least twice from the Department of Neurology, Department of Pediatrics, Samsung Medical Center as of the date of participation in the study
* Those who have been taking one or more anticonvulsants for 3 months or more as of the date of participation in the study
* Those who have passed more than one month from the date of discharge from the hospital as of the date of participation in the study (However, hospitalization for examination only does not fall under this standard)

Exclusion Criteria:

* Those who have an experience of inpatient treatment within 1 month as of the date of participation in the study (However, hospitalization for examination only is not classified as hospitalization under this standard)
* Those who have a record of visiting the emergency room within 1 month as of the date of participation in the study (However, visits that are not for epilepsy drug control are not classified as emergency room visits according to this standard)
* Those who have been diagnosed with psychogenic non-epileptic seizure (PNES) through electroencephalogram (EEG)
Comparison of Primary Repair Versus Gastrocnemius Turn-down Flaps of Acute Achilles Tendon Rupture

This retrospective study includes 74 patients with acute Achilles tendon rupture from March 2012 to September 2018, aiming to compare the mid-term curative effect of primary repair and gastrocnemius turn-down flaps and guide clinical decision.

Objective: To explore the surgical methods and observe the med-term curative effect of primary repair and gastrocnemius turn-down flaps for acute Achilles tendon rupture, so as to guide clinical decision. Methods: This retrospective study includes 74 patients with acute Achilles tendon rupture from March 2012 to September 2018, whose surgeries was completed by the sponsor with either primary repair or gastrocnemius turn-down flaps. The recovery and motor function of the patients were followed up by outpatient clinic and telephone at 3 months, 6 months, 12 months and 24 months after operation, respectively, so as to statistically analyze the med-term curative effects of two surgeries. Specific indicators include: Visual Analogue Scale, American Orthopaedic Foot and Ankle Society Ankle-Hindfoot Score, The Victorian Institute of Sport Assessment-Achilles, The Achilles tendon Total Rupture Score, the Tegner Activity Score, Biodex isokinetic dynamometer system, Postoperative rehabilitation index and complications.

Eligibility Criteria:
Inclusion Criteria:

* history of Achilles tendon injury
* within two weeks of injury
* inability to single heel rise
* more than one year of follow-up
* age under 65

Exclusion Criteria:

* open Achilles tendon rupture
* Achilles tendon terminal disease
* rerupture of Achilles tendon
* history of local corticosteroid injection around the Achilles tendon
* accompanied by fracture, vascular or nerve damage
* not available for regular follow-up
Influence of DM on Artery Blood Flow and Complications After Radial Artery Cannulation

In atherosclerotic patients undergoing kidney transplantation, arterial cannulation is commonly performed for continuous monitoring of systemic blood pressure and intermittent assessment of arterial blood gases. The radial artery is the preferred artery, because of its well-documented low complication rate and easy access, but, radial artery cannulation is may associated with complications. Atherosclerosis is a systemic phenomenon, and structural changes attributable to atherosclerosis, such as luminal narrowing, intimal hyperplasia, and reduction in distensibility occur frequently throughout the arterial tree. Especially in patients with diabetes mellitus (DM), the radial artery is prone to atherosclerosis and perhaps calcification. In a recent study, it was found that the radial artery flow was decreased immediately after cannulation, but recovered to its pre-cannulation value after 5min, whereas a compensatory increase of blood flow in the ulnar artery occured immediately after cannulation, persisting until 5 min. This study enrolled the patients of ASA physical status 1-2. In the patients scheduled for elective kidney transplantation, this compensatory increase of blood flow in the ulnar artery may not be occurred, because of atherosclerosis, particularly in patients with DM. In our study, we found whether there is appropriate compensatory increase of blood flow in the ulnar artery after the radial artery cannulation in two groups, patients with DM (group DM) or without DM (group nonDM), both undergoing elective kidney transplantation.


Eligibility Criteria:
Inclusion Criteria:

* age \> 20yrs undergoing kidney transplantation
* ASA physical status ≥ 3
* patients with DM (DM group), patients without DM (nonDM group)

Exclusion Criteria:

* coagulopathy
* inflammation or infection at the puncture site for cannulation
* a positive result on the modified Allen's test
* the cannulation failed twice
* Acute renal allograft rejection
PROSPective Evaluation of Fortified Eggs Related to Improvement in The Biomarker Profile for Your Health

The objective of the study is to assess the effect of fortified eggs (compared to a non-egg supplemented diet) and intermittent fasting (IF) (compared to a usual care diet) on biomarker profile at 4 months. This will be a 140-participant, 2x2 factorial, randomized clinical trial comparing fortified eggs vs. a non-egg supplemented diet and IF vs. usual care diet through 4 months. Participants will be randomized 1:1:1:1 to the four treatment groups. Participants will have in-person follow-up visits at 1- and 4- months (inclusive of laboratory assessments) in addition to telephone calls at months 2 and 3. A subset of patients (\~24 in each egg randomized strata) will undergo microbiome assessment at baseline and at 4 months.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 50 years of age AND
* At least one of the following two criteria:

  * Prior cardiovascular event (myocardial infarction, coronary revascularization or ischemic stroke) OR
  * 2 cardiovascular risk factors including: 1) Diabetes mellitus (Defined as taking a medication for diabetes OR HgbA1c ≥6.5% within the prior 18 months; patients with diabetes may be treated with medications that are not associated with hypoglycemia such as metformin, thiazolidinediones (TZDs), glucagon-like peptide-1 receptor agonists (GLP-1 RAs), sodium glucose co-transporter 2 (SGLT2) inhibitors and/or dipeptidyl peptidase-4 (DPP-4) inhibitors, 2) Body mass index (BMI) ≥ 30 kg/m2, 3) Hypertension (Defined as taking blood pressure lowering medications OR systolic BP \> 140mmHg at screening OR diastolic BP \> 90mmHg at screening), 4) Dyslipidemia (Defined as taking lipid lowering medication OR LDL ≥130 OR HDL \<50 for women OR HDL \<40 for men OR triglycerides ≥150), or 5) Chronic kidney disease (Defined as eGFR \<60 on most recent laboratory assessment within prior 18 months)
* Signed informed consent

Exclusion Criteria:

* Known allergy or intolerance to eggs
* Patients with diabetes who are on insulin or insulin secretagogues (e.g., sulfonylureas and meglitinides)
* Recent cardiovascular event (MI, stroke, HF hospitalization) within the past 30 days
* Planned initiation/change in lipid therapy within the next 4 months
* Current daily use of any supplements or multivitamins containing Vitamin B2 (riboflavin), Vitamin B12, Vitamin D, Vitamin E, or selenium or planned initiation within the next 4 months (current users need a 1-month washout period off supplement prior to eligibility)
* Inability or unwillingness to comply with the study requirements
* History of heart transplant or left ventricular assist device
* Pregnant or nursing women
* Malignancy or other non-cardiac condition limiting life expectancy to \<4 months
* Consumption of \> 2 eggs per week (this does not include eggs contained within other foods)
* Ongoing or recent (prior 30 days) participation in another interventional study
A Secondary Study Evaluating Aqueduct's Smart External Drain (SED)

Aqueduct's Smart External Drain (SED) will be compared to the current gold standard for temporary CSF management in a hospital setting.

* Evaluate the number of subjects requiring to be switched to a standard of care EVD
* Evaluate subject transport while on the SED
* Evaluate SED system control from initiation of SED through discharge of external drain system

This clinical trial will evaluate Aqueduct's Smart External Drain (SED) upon implementation of ventriculostomy or lumbar drain placement for temporary CSF external management in a hospital setting. Subjects will remain on study from the time of SED application through discharge of the external drain or switch to standard of care extraventricular drain.

Eligibility Criteria:
Inclusion Criteria:

1. Subject scheduled to have an external drain (includes extra-ventricular and lumbar drains) placed as part of routine management.
2. Age 0-80.
3. Able to obtain consent or legally authorized representative (LAR) consents for subject to be treated on study.

Exclusion Criteria:

1. Anticoagulant therapy (does not include DVT or PE prophylaxis).
2. Known bleeding diathesis.
3. Scalp infection.
4. In the opinion of the Investigator the subject is not a good study candidate.
Genomic Study of Genetic Polymorphisms Involved in Immediate Allergic Reactions to Beta-lactam Antibiotics

Beta-lactam antibiotics include penicillin and cephalosporins and are among the most prescribed antibiotics. This category of drugs is the most involved in immediate allergic manifestations with 2% reactions in treated subjects and a fatal outcome in 1/50000 treatments. Reactions are IgE-mediated and have a considerable but unknown genetic origin, revealed by studies in groups of different ethnical origins in the same geographical region. There are also some families with a high frequency of allergic reactions without identified Mendelian inheritance.

The purpose of this study is to identify predictive risk factors associated to immediate allergic reactions against beta-lactam antibiotics with a pangenomic approach.

A secondary purpose is to identify rare predictive factors with homozygosity mapping and exome sequencing in various families with high risk of allergy to beta-lactam antibiotics.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Allergy group: Immediate allergic reaction (less than 2 hours after drug administration) to an antibiotic of penicillin or cephalosporin groups
* Allergy group: Positive skin test (intradermal test) with a non-irritant dilution of antibiotic of penicillin or cephalosporin groups

Exclusion Criteria:

* Refusal of participation
Comparison of Bizact With Electroscissor for Tonsillectomy

In a randomized, partly double-blind prospective setup we want to compare traditional adult electro-scissor tonsillectomy With ultrasound Technology, Bizact.


Eligibility Criteria:
Inclusion Criteria:

* planned elective tonsillectomy
* informed consent

Exclusion Criteria:

* regular use of analgesics pre-operatively
* known tendency of bleeding
* not able to communicate in Norwegian
Tucidinostat Plus PD-1 Inhibitor and Bevacizumab for Advanced Esophagus Cancer, AEG, Gastric Cancer

This Phase II study was designed to assess the efficacy and safety of the combination of PD-1 inhibitor, Tucidinostat (chidamide), a histone deacetylase inhibitor, and bevacizumab in advanced Esophageal squamous cell cancer, adenocarcinoma of esophagogastric junction, Gastric adenocarcinoma patients.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years, ≤ 75 years
2. Histologically or cytologically confirmed Esophageal squamous cell cancer, adenocarcinoma of esophagogastric junction and Gastric adenocarcinoma, unresectable, recurrent or metastatic disease.
3. Can provide at least 5 pieces of pathological section or fresh tumor tissue
4. Eastern Collaborative Oncology Group (ECOG) ≤ 1.
5. ≤2 systemic chemotherapy for advanced disease (total number of treatment lines for advanced disease ≤4).
6. Patients who have previously used PD-1 antibodies, PD-L1 antibodies, PD-L2 antibodies, or CTLA-4 antibodies (or any other antibodies acting on T cell co-stimulation or checkpoint pathways) or require a duration of ≥16 weeks;
7. Adequate organ function.
8. Life expectancy is more than 3 months.
9. For females of child bearing potential, a negative urine or serum pregnancy test result within 3 days before study treatment.
10. Willing and able to provide written informed consent.

Exclusion Criteria:

1. Allergies to any monoclonal antibody or Tucidinostat preparation have been known, and hypersensitivity reactions of more than 3 levels have occurred
2. Previously received immunotherapy and had grade 3 or above immune-related adverse events.
3. Previously received histone deacetylase inhibitors,or toripalimab, or angiogenesis inhibitors.
4. Subjects with any active, known or suspected autoimmune disease or history of autoimmune disease.
5. Known active CNS metastases and/or carcinomatous meningitis.
6. Received a live vaccine within 4 weeks of the first dose of study medication.
7. Major surgery received or severe traumatic injury, fracture, or ulcer occurred within 4 weeks of the first dose of study medication.
8. Pregnant or lactating female.
9. Uncontrolled clinically significant systemic diseases, including active infection, unstable angina, angina occurred within 3 months,≥ NYHA II congestive heart failure, myocardial infarction occurred within 6 months, severe arrhythmia, liver, kidney, or metabolic disease.
10. Participate in other clinical trials currently or within 4 weeks prior to enrollment.
Study of Patients With Strongyloides Stercoralis Infection

This study will explore faster and easier ways to detect infection with the intestinal parasite Strongyloides stercoralis and learn more about the conditions under which it causes serious disease. Ordinarily, the Strongyloides helminth (type of intestinal worm) causes only few, if any, symptoms, but in people with weakened immunity it may be very serious, and even deadly.

People between 5 and 80 years of age with known or suspected S. stercoralis infection, or infection with another helminth, such as filariasis, that might cause a cross-reaction with S. stercoralis may be eligible for this study.

Participants found to be infected with S. stercoralis will be treated with ivermectin, thiabendazole, or albendazole. In addition, they will undergo the following tests and procedures:

* Blood tests and stool samples: Samples will be collected before and after treatment to check general health status and immune function, and to look for parasites in stool. Up to 50 milliliters (10 teaspoons) of blood will be drawn in adults and up to 25 ml (5 teaspoons) in children.
* Skin tests: A test similar to those used for tuberculosis and allergies will be conducted to determine if there is sensitization to products of the parasite. Such a test might be used as a rapid method to diagnose the infection. About three drops of several different antigens (proteins) are injected into the skin of the arm. After 15 to 20 minutes, the area is checked to see if a red spot has formed and, if so, the spot is measured.

This study is directed to patients with known or suspected Strongyloides stercoralis infection because it is a relatively common parasitic infection, even in the United States. It is difficult to diagnose, and efficacy of treatment is difficult to evaluate. Some infected individuals can develop serious even fatal, disease under certain conditions of immunosuppression. Because newer diagnostic methods are needed to diagnose this infection, we have developed new diagnostics that will be evaluated in comparison to more standard diagnostic tests. Serum and cells will also be collected from patients on this protocol to understand the cellular and humoral response to the parasite and its antigens. All subjects proven to have Strongyloides stercoralis infection will be treated with standard therapy and followed to assess both the efficacy of treatment and the changes in humoral and cellular immune responses induced by treatment.

Eligibility Criteria:
* INCLUSION CRITERIA:

Age of 5 to 80 years and of either sex.

Access to primary medical care provider outside of the NIH

Ability to give written informed consent (for adults) and parental consent (for those under 18)

Presence of known or suspected infection with Stronglyloides stercoralis, such as significant peripheral blood eosinophilia (greater than 1000 eosinophils/mm(3)) for which no other cause is apparent.

Willingness to participate and provide blood for in vitro assays and serum storage.

EXCLUSION CRITERIA:

Less than 5 years of age

Pregnancy is not a criterion for exclusion.
Post-operative Pain After Shoulder Surgery

A prospective observational study conducted at the American University of Beirut Medical center that targets patients undergoing shoulder surgeries. It is conducted to to prospectively collect patient, surgery and anesthesia-related variables and perform correlation studies with postoperative pain severity, patients' satisfaction and analgesic consumption following shoulder surgery.

In addition, identifying predictors for postoperative pain will contribute to adjust pain management protocols as per surgical and patients' factors.


Eligibility Criteria:
Inclusion Criteria:

* All adult patients \> 18 years old admitted to the American University of Beirut - Medical Center for any shoulder surgery

Exclusion Criteria:

* Patients suffering of opioids addiction (or previous history of addiction) or drug abuse.
Study of WVE-004 in Patients With C9orf72-associated Amyotrophic Lateral Sclerosis (ALS) or Frontotemporal Dementia (FTD)

This is a Phase 1b/2a multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, PK, and PD of intrathecal (IT) WVE-004 in adult patients with C9orf72-associated ALS or FTD. To participate in the study, patients must have a documented mutation (GGGGCC \[G4C2\] repeat expansion) in the first intronic region of the C9orf72 gene and be diagnosed with ALS or FTD.


Eligibility Criteria:
Inclusion Criteria:

1. ALS-specific: Diagnosis of ALS based on clinical manifestations.
2. ALS-specific: Clinically diagnosed possible, laboratory supported probable, probable, or definite criteria for diagnosing ALS according to the World Federation of Neurology revised El Escorial criteria.
3. ALS-specific: Patients receiving riluzole have been on a stable dose for a minimum of 30 days.
4. ALS-specific: Patients on edaravone have received a minimum of 1 cycle (28 days).
5. ALS-specific: Patients discontinuing riluzole or edaravone had the last dose administered ≥1 month prior to Screening.
6. FTD-specific: Must have Global Clinical Dementia Rating - Frontotemporal Lobar Degeneration (CDR® plus NACC FTLD) score of 0.5 or 1.
7. FTD-specific: Able to undergo periodic magnetic resonance imaging (MRI) of the brain. Participants with mixed phenotype (ALS and FTD) need not undergo MRI if their ALS symptoms prevent it.
8. Mixed-phenotype: Patients who are mixed phenotype (ALS and FTD) must meet both the ALS-specific and FTD-specific criteria.

Exclusion Criteria:

1. Clinically significant medical finding on the physical examination other than C9orf72-associated ALS or FTD that, in the judgment of the Investigator, will make the patient unsuitable for participation in, and/or completion of the trial procedures
2. Received any other investigational drug, biological agent, or device within 1 month or 5 half-lives of study agent, whichever is longer. Received an investigational oligonucleotide, within the past 6 months or 5 half-lives of the drug, whichever is longer.