cyrilzakka/clinical-trials huggingface dataset:
Safety, PK and PD of Kamada Anti-SARS-CoV-2 in COVID-19

Evaluate the safety pharmacokinetics and pharmacodynamics (PK/PD)of a single dose of Kamada anti-severe acute respiratory syndrome (SARS)- CoV-2 in patients hospitalized with COVID-19 caused pneumonia


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. Laboratory confirmed SARS-CoV-2 infection by nasopharyngeal swab Real time polymerase chain reaction (RT-PCR)
3. Hospitalized for COVID-19 pneumonia
4. Dosing should be within 10 days of symptom start
5. Able and willing to sign informed consent form

Exclusion Criteria:

1. History of hypersensitivity to plasma products and/or severe Immunoglobulin A deficiency (\< 7 mg/dL)
2. Requirement of high flow oxygen devices, or non-invasive ventilation or mechanical ventilation, or extracorporeal membrane oxygenation (ECMO) at screening
3. Cardiovascular instability
4. History of thrombo-embolic events
5. Acute renal failure or creatinine \>2 mg/dL or estimated estimated glomerular filtration rate (eGFR) \<30 mL/min
6. History of lung transplantation
7. Major surgery (abdominal and chest) within the last 4 weeks
8. Severe chronic background disease, per investigator's judgement for example, Cirrhosis grade C, Dialysis, cardiac insufficiency (NYHA III), pulmonary disease (FEV1\<50 percent of predicted) etc.
9. Pregnancy or lactation
10. Treatment with plasma units or immunoglobulin preparations within the last 4 weeks
11. Participation in another pharmaceutical interventional clinical study within 4 weeks from screening
Clinic-based HIV Identification and Prevention Project Using Electronic Resources

Hybrid Type II effectiveness-implementation trial to investigate whether electronic medical and sexual history data collection with HIV risk categorization/scoring will increase pre-exposure prophylaxis (PrEP) uptake among cis-gender women attending routine well-woman gynecologic preventative visits.

Forty-two Obgyn providers will be randomized into 1 of three arms. Patients of enrolled providers who attend an ObGyn clinic for any preventative visit will complete an electronic history form (eHxForm) before clinic through a message sent through the patient portal (MyChart), email, or secure text messaging. The sexual history questions will be scored and categorized into 3 categories. Patients with a low score (0-3) will receive an electronic message offering a laboratory HIV test per USPSTF guidelines. If she accepts, then an automated Epic order will be placed for the provider to sign during the office visit.

Patients with a medium/high score (4-10) will be assigned a study arm based on their provider's group (arm 1: control, arm 2: patient will view score and a PrEP video, arm 3: procedures in arm 2 PLUS providers will receive an electronic health record alert that the patient may have HIV risk factors. This will occur automatically via programming integrated into the electronic health record. The primary outcome is PrEP uptake. The implementation strategy will be evaluated using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework.

Eligibility Criteria:
Inclusion Criteria:

* Patients of enrolled providers aged 15-65 years
* Presenting for preventive care (i.e., well-woman exam, sexually transmitted infection testing, pre-conception counseling, or birth control).

Exclusion Criteria:

* Pregnant and has established prenatal care, i.e., visit is for prenatal care
* Non-English or non-Spanish speaking
* Living with HIV
* Unable to complete the eHxForm
Effects of Scapular Exercise on Patients With Scapulocostal Syndrome

The purpose of this study is to determine the effect of scapular exercise on pain related parameters including pain intensity, 24 hours pain intensity, pressure pain threshold, anxiety and muscle tension in patients with scapulocostal syndrome.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female
2. Age between 18 - 50 years old
3. The participants have experienced spontaneous scapular pain for longer than 12 weeks (chronic) and that at least one trigger point will be present in the scapular region (serratus posterior superior, rhomboid groups, levator scapulae and trapezius muscles). Trigger points will be diagnosed as the presence of focal tenderness in a taut band and with pain recognition (Chatchawan et al., 2005; Tough et al., 2007).
4. The participants will be able to follow instructions.
5. Good communication and cooperation.

Exclusion Criteria:

1. A history of the following diseases or disorders:

* Rotator cuff disease
* Cervical radiculopathy
* Degenerative shoulder joint disease
* Adhesive capsulitis of shoulder
Pain Threshold Measurements in High and Low Altitude Among Healthy Volunteer Adults: A Comparative Study

one measurement of pain threshold in high altitude and in low altitude using pressure algometer and Situational pain scale.

the aim of the study is to compare between pain threshold in high 1.9000 m above sea level and low altitude at sea level in healthy volunteer adults.

Assessment performed using:

1. pressure algometer.
2. situational pain scale

Eligibility Criteria:
Inclusion Criteria:

* age 18-52 years old.
* healthy volunteers

Exclusion Criteria:

* no musculoskeletal problems including muscle spasm
* no recent injuries or operations.
* not suffering from any painful condition.
* not on pain medications or antidepressant
THE ASSOCIATION BETWEEN FATTY LIVER (NAFLD) DISEASE AND PCOS

Since both pathologies (PCOS and NAFLD) involve disturbed carbohydrate economy, which revolve around insulin resistance, it is tempting to examine the specific "liver profile" of women with PCOD. Furthermore, it would be of great importance if lean women who suffer from PCOD would be revealed to shere cardiovascular risks with their more overweight peers.

Patients - women who will be diagnosed with PCOD following their initial referal to our fertility clinic. Controls - normal ovulatory women who approached our fertility clinic due to either unexplained or male factor infertility.

Workup - history for menstrual pattern; Clinical evaluation for features of hyperandrogenism; ultrasonographic documentation of ovarian morphology; follicular phase hormonal profile for validation of the diagnosis and for ruling out other pathologies which may cause anovulation.

Liver profiling - The following blood tests will be used for the biochemical profiling: fasting glucose and insulin, CRP, HDL-cholesterol, triglycerides, AST, ALT, GGT, LDH, alkaline phosphatase, total bilirubin, direct bilirubin, ferritin, HBA1C and micro albumin ratio.

FibroScan® will be used to measure liver stiffness.


Eligibility Criteria:
Workup - history for menstrual pattern; Clinical evaluation for features of hyperandrogenism; ultrasonographic documentation of ovarian morphology; follicular phase hormonal profile for validation of the diagnosis and for ruling out other pathologies which may cause anovulation.

Liver profiling - The following blood tests will be used for the biochemical profiling: fasting glucose and insulin, CRP, HDL-cholesterol, triglycerides, AST, ALT, GGT, LDH, alkaline phosphatase, total bilirubin, direct bilirubin, ferritin, HBA1C and micro albumin ratio.

FibroScan® will be used to measure liver stiffness, as previously described
Sunphenon Epigallocatechin-Gallate (EGCg) in Duchenne Muscular Dystrophy

The aim of this multicentre, prospective, double blind, placebo controlled, randomized pilot study is to investigate safety and tolerance of Epigallocatechin-Gallate (EGCG, the major polyphenol in green tea) in patients with muscular dystrophy of the Duchenne type.

In a second step the investigators want to investigate the effect of EGCG on the course of the Duchenne condition.

Duchenne muscular dystrophy (DMD) is the most frequent neuromuscular condition to occur in childhood and youth. The course of the disease is progressive, and life expectancy is severely curtailed by the participation of the respiratory muscles and/or by progressive cardiomyopathy.

DMD derives from mutations in the DMD gene which leads to a loss of the protein dystrophin. Secondary inflammatory/immunological reactions contribute to the progressive course of the disease (1,2).

No curative therapy yet exists. Administration of steroids is the only established medical treatment. Symptomatic measures are also available, such as orthopaedic operations, the treatment of cardiomyopathy or, in advanced stages, home mechanical ventilation.

In studies involving experiments on cells and animals, Epigallocatechin-Gallate (EGCG, the major polyphenol in green tea) has shown a neuroprotective effect. The neuroprotective mechanism of action is probably based on several factors, including EGCG's modulation of several signal transduction pathways, its influence on the expression of genes regulating cell survival or programmed cell death, as well as its modulation of mitochondrial function.

The mdx mouse is the best-investigated animal model of a dystrophin-negative muscular dystrophy. Administration of EGCG in the mdx mouse led to both a reduction in the proportion of fibre necroses as well as to a less pronounced proliferation of connective tissue in the muscle (3,4), and also to an improvement in clinical symptoms (5,6).

Therefore, the investigators want to investigate safety and tolerance of EGCG in a dosage of up to 10mg/kg in patients with muscular dystrophy of the Duchenne type in this multicentre, prospective, double blind, placebo controlled, randomized pilot study.

Eligibility Criteria:
Inclusion Criteria:

* Duchenne muscular dystrophy
* age 5-10 years
* ability to walk without support
* informed consent by the parents

Exclusion Criteria:

* another serious organic disease
* further primary psychiatric or neurological diseases
* long-term intake of liver-toxic medicines
Sonographic Evaluation of Diaphragmatic Function in Critical Care Patients With Use of Non Invasive Ventilation

Usefulness of non invasive ventilation in patients extubated after more than 48 hours of invasive ventilation is still in debate except for specific patients (chronic pulmonary disease and chronic heart failure).

Many experimental and clinical studies have shown that diaphragmatic function is depressed by mechanical ventilation in intubated patients.

The investigators will test the hypothesis that non invasive ventilation after extubation may improve diaphragmatic function


Eligibility Criteria:
Inclusion Criteria:

* Patient extubated after at least 48 hours of invasive ventilation
* Requiring non invasive ventilation
* Consent of patient

Exclusion Criteria:

* Diaphragmatic paralysis
* Neuromuscular disease
* significant pleural effusion
* atelectasis requiring bronchoscopy
* abdominal hypertension
Fecal Microbiota Transfer in Liver Cancer to Overcome Resistance to Atezolizumab/Bevacizumab (FLORA)

The interventional, randomized, placebo-controlled, single blind phase II-trial FLORA will assess safety and immunogenicity of fecal microbiota transfer in combination with standard of care immunotherapy in advanced hepatocellular carcinoma (HCC) in a parallel group design.

Subjects will be randomized 2:1 into either the FMT or placebo group.

Eligible HCC patients visiting the outpatient clinics of LCCH at the study sites at NCT Heidelberg and University Medical Center Mannheim will be enrolled into the study after informed consent. Patients undergo 2:1 randomization into either the FMT or placebo group. Study lead in with a first sonographically guided tumor biopsy, if not already performed for diagnostic purposes, and a sigmoidoscopy will be scheduled within 10 days after study enrollment in an outpatient setting. Start of active pharmacotherapy with A/B will begin within five working days after sigmoidoscopy. A/B administration will be administered as standard of care every 21 days. At day -3 to 0 oral Vancomycin will be given 4x 250mg to the verum group. At day 0 and 21, concurrent to the first and second cycle of A/B, encapsulated FMT will be administered on the same day. At day 40-42, before the third cycle of A/B, a second biopsy of the liver lesion and a sigmoidoscopy will be performed. Clinical efficacy and safety will be assessed as indicated per protocol analysis.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years or older
2. Confirmed imaging or histological diagnosis of unresectable HCC, BCLC stadium C
3. ECOG performance status of 0-1

Exclusion Criteria:

1. Advanced liver cirrhosis (Child-Pugh Score C)
2. Diagnosis of immunodeficiency (e.g. HIV, immunosuppressants)
3. Usage of antibiotics within 2 weeks prior enrollment
Reducing the Overall Risk Level in Patients Suffering From Metabolic Syndrome

This study will evaluate the efficacy of a multi factorial preventive scheme of action (including fluvastatin and valsartan) to reduce the overall risk level in patients with metabolic syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Age between 40 - 65 years
* Diagnosed metabolic syndrome
* Risk of cardiovascular death ≥ 5% (according to SCORE)
* Written informed consent

Exclusion Criteria:

* Women not in menopause or not using efficient contraception
* Known hypersensitivity to study drugs
* History of ischemic heart disease
Use of the Napoleon to Improve Polyp Measurement in Gastroenterology Fellows

This is a clinical trial assessing gastroenterology fellows' accuracy of colonic polyp measurement using a Micro-Tech Endoscopic Polyp Measurement Device named Napoleon. The study will evaluate the feasibility of Napoleon as a polyp measurement device. Investigators will collect data on inpatient and outpatient colonoscopies performed by fellows at NYU Langone Health, NYU Langone Hospital Brooklyn, Bellevue Hospital Center, and Manhattan VA Medical Center from May 2021 - May 2022 for 150 patients. Investigators will include all colonoscopies with polyps done in adults age 45 and above. For each colonoscopy, a fellow will first visually estimate the polyp size and then measure the polyp with Napoleon. Investigators will calculate the difference in polyp measurement between visual assessment and using Napoleon for each fellow year and compare differences among fellow years. Investigators will evaluate for changes in fellows' accuracy of polyp measurement with subsequent uses of Napoleon. Investigators will determine the proportion of cases with a change in the recommended surveillance interval based on polyp size. A survey will be given to all fellows to assess the level of ease with using Napoleon.


Eligibility Criteria:
Patients:

Inclusion Criteria:

1. Adult age 45 and above
2. Undergoing a colonoscopy performed by a gastroenterology fellow
3. Willingness and ability to provide informed consent

Exclusion Criteria:

1. History of not tolerating prior colonoscopies well or difficult colonoscopies (e.g. high sedative requirement)
2. Undergoing a diagnostic colonoscopy for inflammatory bowel disease or other known inflammatory/infectious process

An individual who meets any of the following criteria during the colonoscopy will be excluded from participation in this study:

1. Colonoscopy without polyps
2. Polyps not removed in entirety
3. Polyps with indeterminate size

An individual who meets any of the following criteria after the colonoscopy will be excluded from participation in this study:

1. Hyperplastic or non-adenomatous polyps on pathology report

Fellows

Inclusion Criteria:

1. NYU gastroenterology fellow
2. Willingness and ability to provide informed consent

Exclusion Criteria:

1. Not deemed to be medically trained and ready to perform a colonoscopy by supervising gastroenterology attending
EPAP, Interviewstudy

The goal of this observational study is to learn about repetitive anaphylactic reactions in food allergic patients and to compare the frequency of repetitive reactions between different elicitors in food allergic patients. The main question it aims to answer are:

• Is there an elicitor specific difference in the occurrence of anaphylactic reactions once the elicitor has been identified and the patient received counselling about its avoidance?

Participants will answer questionnaires via a link they will receive via e-mail at baseline and 3, 6, 12 and 24 months after inclusion in the study.

The aim of the study is to establish a cohort of patients who were included in the anaphylaxis registry with an anaphylactic reaction to legumes, tree nuts, seeds, grains or pseudocereals within the previous twelve months. Patients are requested to provide information about the occurrence of new allergic reactions at defined time-points over a period of two years (at baseline, 3, 6, 12, and 24 months). In addition, their eating behavior and the food allergy-specific quality of life will be captured. The investigators intend to track self-management in dealing with anaphylaxis, especially the use of emergency medication. It is examined whether patients react again and whether these are reactions to a known or previously unknown allergen to the patient. By recording the symptoms, it will be checked whether there are certain reaction patterns to specific foods or whether these are patient specific. In addition, the influence of the previous anaphylactic reaction and knowledge of the existing allergy on quality of life, dietary behavior and the ability to use emergency medication should be examined.

This is intended to help improve the care for future patients in order to minimize the risk of repeat reactions.

Eligibility Criteria:
Inclusion Criteria:

* anaphylactic reaction to peanuts, other legumes, tree nuts, seeds (e.g. sesame seed, sunflower seed), cereals (e.g. wheat, oat) or pseudocereals (e.g. quinoa)
* participation in the European Anaphylaxis Registry (Clinical Trials Identifier: NCT05210543)
* possibility and consent to receive links to the follow-up electronic surveys via e-mail and fill out the questionnaires electronically

Exclusion Criteria:

* if inclusion criteria are fulfilled there are no further exclusion criteria
Study of GVAX (With CY) and Pembrolizumab in MMR-p Advanced Colorectal Cancer

This study will be looking at the objective response rate (ORR) as measured by RECIST in in patients with mismatch repair-proficient (MMR-p), advanced colorectal cancer that treated with CY/GVAX in combination with Pembrolizumab.


Eligibility Criteria:
Inclusion Criteria:

1. Documented mismatch repair-proficient cancer of colorectum, who have received at least two prior lines of therapy for metastatic disease
2. Measurable disease by RECIST v1.1
3. Age \>18 years
4. ECOG Performance Status of 0 to 1
5. Estimated life expectancy of greater than 3 months.
6. Adequate organ function as defined by study-specified laboratory tests
7. Must use acceptable form of birth control through the study and for 120 days after final dose of study drug
8. Signed informed consent form
9. Willing and able to comply with study procedures

Exclusion Criteria:

1. Has a known additional malignancy that is progressing or requires active treatment.
2. Has known central nervous system (CNS) metastases and/or carcinomatous meningitis.
3. Has known malignant small bowel obstruction within the last 6 months.
4. Currently have or have history of certain study-specified heart, liver, kidney, lung, neurological, immune or other medical conditions.
5. Systemically active steroid use.
6. Has an active infection requiring systemic therapy.
7. Has a known history of active TB (Bacillus Tuberculosis).
8. Infection with HIV or hepatitis B or C.
9. Has history of (non-infectious) pneumonitis that required steroids.
10. Must not require supplemental oxygen or have a pulse oximetry \< 92% on room air.
11. Conditions, including therapy, laboratory abnormalities, psychiatric or substance abuse disorders, intercurrent illness, or lack of sufficient peripheral venous access, that would affect the patient's ability to comply with study visits and procedures.
12. Pregnant or lactating.
13. Another investigational product within 28 days prior to receiving study drug.
14. Major surgery or significant traumatic injury (or unhealed surgical wounds) occurring within 28 days prior to receiving study drug.
15. Chemotherapy, radiation, hormonal, or biological cancer therapy within 28 days prior to receiving study drug.
16. Has received a live vaccine within 30 days of planned start of study therapy.
17. Prior treatment with immunotherapy agents (including, anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA4, etc.).
18. Patients receiving growth factors including, but not limited to, granulocyte-colony stimulating factor (G-CSF), GM-CSF, erythropoietin, within 14 days of study drug administration.
19. Hypersensitivity to pembrolizumab or any of its excipients.
20. Patient has a known or suspected hypersensitivity to GM-CSF, hetastarch, corn, dimethyl sulfoxide, fetal bovine serum, trypsin (porcine origin), yeast or any other component of GVAX vaccine.
21. Presence of any tissue or organ allograft and history of allogeneic hematopoietic stem cell transplant.
22. Unwilling or unable to comply with study procedures.
A Clinical Study of the Cryoablation Technique for Peripheral Lung Malignancies

To assess the safety and effectiveness of bronchoscopy-guided cryoablation with cold verification for peripheral lung malignancies.


Eligibility Criteria:
Inclusion Criteria:

* (1) Age ≥ 18 years, with no gender restrictions; (2) Diagnosed as having peripheral lung cancer, with the maximum diameter of the tumor being ≤ 3 cm and the number of tumors being ≤ 3; (3) The lesion intended for ablation is evaluated as feasible for bronchoscopy-guided cryoablation therapy; (4) The subject refuses or is deemed unsuitable for radiotherapy/chemotherapy, or has no response to previous radiotherapy/chemotherapy, or has disease progression after radiotherapy/chemotherapy; (5) Assessed as ineligible for surgery or refuses surgery and radiotherapy, consents to receive initial ablation treatment and signs the informed consent form.

Exclusion Criteria:

* (1) Diffuse lesions in both lungs where ablation therapy fails to improve the condition; (2) Examinations within one month prior to the operation reveal the presence of hilar lymph node metastasis or extrapulmonary metastasis (except for cases where extrapulmonary metastasis has been controlled through local treatment); (3) Existence of contraindications for bronchoscopy, or inability of the patient to tolerate or cooperate with bronchoscopy; (4) Severe bleeding tendencies or uncorrectable coagulation dysfunctions (prothrombin time \> 18 seconds, prothrombin activity \< 40%); (5) Platelet count \< 70×109/L, or discontinuation of anticoagulant and/or antiplatelet drugs less than one week before ablation (except for the prophylactic use of low-molecular-weight heparin before the operation); (6) Severe impairment of lung function with a maximum ventilation volume \< 40%; (7) Concurrent presence of other tumors with extensive metastasis and an expected survival period of less than 3 months; (8) Poor overall condition (multiple metastases throughout the body, severe infection, high fever), infectious and radiation-induced inflammation around the lesion, obvious cachexia, severe dysfunction of important organs, severe anemia and short-term uncorrectable nutritional and metabolic disorders; (9) Eastern Cooperative Oncology Group (ECOG) performance status score \> 2; (10) The lesion to be ablated has received radiotherapy within the past 6 months; (11) Active hepatitis B, active hepatitis C, human immunodeficiency virus (HIV) infection history (known positive for HIV1/2 antibodies), or other active infections that are judged by the researcher to potentially affect the patient's treatment; (12) Accompanied by epilepsy, history of mental illness or cognitive impairment; (13) Pregnant or lactating women, as well as male or female patients who plan to have children or become pregnant during the trial; (14) Participation in any other clinical trials within 3 months before signing the informed consent (excluding non-interventional studies); (15) Other circumstances deemed by the researcher as inappropriate for participation in this clinical trial.