cyrilzakka/clinical-trials huggingface dataset:
Pilot Study of Exenatide Pharmacokinetics and Pharmacodynamics in Gestational Diabetes

This study is being done to study how exenatide, an FDA-approved drug that lowers blood sugar in non-pregnant patients with type II diabetes, works in pregnant women. To do this, we will study the drug's pharmacokinetics (what the body does to the drug; specifically, how quickly your body breaks down and excretes exenatide) and pharmacodynamics (what the drug does to the body; specifically, how effectively exenatide helps your pancreas secrete insulin and how well it controls blood sugar after a meal). There are only two main drug therapies (insulin injections and glyburide pills) currently used for gestational diabetes and not all women achieve good enough blood sugar control without side effects. Therefore, we hope to find out if exenatide might also be helpful in gestational diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women (singleton)
* Gestational diabetes not requiring medical therapy
* Between 18 and 50 years of age
* Able to give written informed consent

Exclusion Criteria:

* Women in the first trimester of pregnancy
* Hematocrit less than 30%
* Current or past treatment with any hypoglycemic agent
* Women with gastrointestinal disease or symptoms consistent with nausea, vomiting, abdominal pain or reflux requiring medical treatment.
* Women with high triglyceride levels, history of gallbladder or pancreatic disease.
* Clinical diagnosis or history of any renal insufficiency (or decreased creatinine clearance)
Intravitreal Aflibercept Injection or Early Vitrectomy for Diabetic Vitreous Hemorrhage

Prospective study comparing efficacy and safety of intravitreal aflibercept injection and panretinal photocoagulation to early vitrectomy for patients with diabetic vitreous hemorrhage.

Selected patients were divided into two groups, Group I for whom intravitreal aflibercept injection followed by panretinal photocoagulation was done and group II for whom early vitrectomy was done.

Eligibility Criteria:
Inclusion Criteria:

* Age above 18 years.
* Any sex.
* Type Ι or ΙΙ DM,
* recent diabetic VH which is causing vision impairment, precluding complete PRP and needing treatment.
* BCVA is less than 20/70 (log MAR BCVA 0.6) and better than 20/1000 (log MAR BCVA 1.7).

Exclusion Criteria:

* Tractional retinal detachment.
* Previous PRP.
* History of anti VEGF therapy within the past two months.
* Neovascular glaucoma
* Subhyaloid hemorrhage.
* Vitreomacular traction.
* Diabetic macular edema .
* Patients with systemic contraindications for anti VEGF or unstable medical conditions as uncontrolled hypertension (persistently above 180/110 mmhg) or recent thromboembolic event within the past six months.
Effects of Green Coffee Extract Supplementation on Leptin, Ghrelin, Adiponectin,Anthropometric Measurements, Lipid Profile in Breast Cancer Survivors

To study the effects of green coffee supplement on leptin, adiponectin, ghrelin, anthropometric measurements, lipid profile in breast cancer survivors.50 breast cancer survivors who their treatment is over and referred to follow breast cancer clinic with will be randomly allocated to receive placebos or 2 capsules green coffe for 12 weeks; both groups will be advised to adherence the investigators' diet and exercise program too. At the first and the end of the intervention, leptin, adiponectin, ghrelin, anthropometric measurements, lipid profile will be assessed and compared between groups.


Eligibility Criteria:
Inclusion Criteria:

* Age of 18 to 70 years
* Body Mass Index (BMI) between 25-40 treatment is over

Exclusion Criteria:

* -Taking any kind of supplement for weight reduction
* pregnancy or lactation
* Professional athletes
Bleeding Events and Oral Anticoagulant Treatment in Non-Valvular Atrial Fibrillation

In a population of patients with non-valvular atrial fibrillation (NVAF), and treated with oral anticoagulants (OAC) in routine clinical practice in England, this study will describe patients treated with each OAC, and to estimate and compare event rates of treatment discontinuation, bleeding, and healthcare resource utilisation (HCRU) across OAC treatments.


Eligibility Criteria:
Inclusion Criteria:

1. Have a prescription for apixaban, rivaroxaban, dabigatran, or VKA during the study period
2. Are ≥ 18 years of age at index date
3. Have ≥ 12 months of computerised medical data prior to index date (date of OAC initiation)
4. Have a record of AF on or ever prior to index date

Exclusion Criteria:

1. Have a record for a valvular condition that is considered causal for AF on or ever prior to index date
2. Have a history of the OACs which are prescribed during the study period (ie, history of index OAC, as patients need to be newly prescribed either apixaban, rivaroxaban, dabigatran, or VKA)
3. Have more than 1 OAC exposure which starts on the same date
Effects of Neoadjuvant Therapy With Carboplatin, Paclitaxel Combined With Anti-PD-1 Drugs on Cognitive Function in Patients With Resectable Head and Neck Squamous Cell Carcinoma

The goal of this observational study is to learn about the Effects of neoadjuvant therapy with carboplatin, paclitaxel combined with anti-PD-1 drugs on cognitive function in patients with resectable head and neck squamous cell carcinoma: a prospective cohort study


Eligibility Criteria:
Inclusion Criteria:

* 1: The patient was diagnosed with head and neck squamous cell carcinoma (stage I-IVA), without treatment, and planned to undergo only surgical treatment or surgical treatment + chemotherapy and immunotherapy.

  2: Can speak Chinese and have certain reading and writing skills

  3: Healthy group: Dental inpatients with non-oral cancer, no history of neurological diseases, and no previous history of malignant tumors

Exclusion Criteria:

* 1: Brain tumor, brain injury, or stroke at baseline or during follow-up

  2: A history of stroke or a medical condition that puts you at high risk for future dementia or recurrence

  3: Active mental illness or active narcotic drug use, including using alcohol more than 4 times per day or more than 4 times per week

  4: Neurocognitive diseases that affect cognitive function, such as Parkinson's disease or Alzheimer's disease

  5: History of drug-associated encephalopathy or brain infection

  6: Patients who change their treatment plan during treatment

  7: Patients who are currently taking or have taken antidepressants
Dasatinib Combined With Chemotherapy in Relapsed t(8;21) Acute Myeloid Leukemia With KIT D816 Mutation

In this multi-center, open-label, no control,prospective clinical trial, a total of 30 relapsed acute myeloid leukemia with t(8;21) translocation and KIT D816 mutation patients will be enrolled. Dasatinib 70 mg twice a day will be administrated for two weeks from day 1 of re-induction chemotherapy. The purpose of current study is to determine the clinical efficacy and tolerability of combination therapy of dasatinib with multi-agent chemotherapy in relapsed acute myeloid leukemia with t(8;21) translocation and KIT D816 mutation.


Eligibility Criteria:
Inclusion Criteria:

1. T(8;21)acute myeloid leukemia patients with KIT D816 mutation diagnosed by bone marrow morphology, immunology, molecular genetics. The diagnosis and classification are according to WHO 2016 criteria.
2. Conform to relapsed diagnosis.Only morphological relapsed cases will be enrolled.Molecular relapsed and isolated extramedullary relapsed cases are not eligible.
3. Age is not limited. Both male and female are eligible.
4. Eastern Cooperative Oncology Group performance status (ECOG-PS):0-2 point.
5. Informed consent form must be signed by patients themselves before enrolled for patients aged 18 years or older. Informed consent form must be signed by the legal guardian for patients younger than 18 years.

Exclusion Criteria:

1. Patients with other blood diseases at the same time (such as haemophilia, primary myelofibrosis and so on) are not considered suitable.
2. Isolated extramedullary relapsed leukemia.
3. With other malignant tumors accompanied with AML and needed treatment. 4 .Patients who are unsuitable for the trial considered by investigators.
Comparing Single Photon Emission Computed Tomography (SPECT) and Liver Biopsy to Evaluate the Liver in Patients With HIV and Hepatitis C Virus

The purpose of this study is to find if the Single Photon Emission Computed Tomography (SPECT) scan is as effective as a liver biopsy (using a special needle to remove tissue from the liver) in examining liver damage in patients with HIV and hepatitis C virus (HCV).

A standard way to examine the liver for disease has been to perform a liver biopsy. The SPECT scan, which takes a picture of the liver, has been found to be effective in determining liver damage but studies need to be done in patients with hepatitis. This study will compare the effectiveness of the liver biopsy and SPECT scan in determining liver disease in patients with HIV and HCV. The SPECT scan might be a good replacement for the liver biopsy if it is found to be as good as or better than liver biopsies.

Assessment with a liver biopsy is currently the standard of practice to determine the status of liver involvement in patients with HCV. A direct comparison between SPECT results and liver pathology has been examined in patients with liver disease other than infectious hepatitis. SPECT has been found to be more accurate than standard liver-spleen scans in assessing liver pathology. While current data suggest that liver pathology may correlate with SPECT, which specific SPECT parameters are predictive of certain hepatic pathology is unknown. The pilot study will compare SPECT parameters with the results of liver biopsies to determine the limitations of SPECT.

All screened patients are registered into Step 1, in which they receive a radioactive tracer injection and SPECT scan. Specific SPECT parameters will be measured to determine a grading scale corresponding to that used in liver biopsy results. Some patients undergoing a second liver biopsy in A5071 are enrolled into Step 2, with permission from protocol co-chairs, in which a pregnancy test and second SPECT scan are performed. Patients are reimbursed for completing each SPECT scan. SPECT scans or copies are reviewed to establish which parameters correspond to category E of the Knodell stage based on severity of fibrosis.

Eligibility Criteria:
Inclusion Criteria

Patients may be eligible for this study if they:

* Are enrolled in, or will soon enroll in, A5071. Patients may be eligible for the study if they are screening for A5071 and have a liver biopsy and SPECT scan but do not enter A5071. Patients who have stopped taking A5071 study drugs may also be eligible.
* Have had a liver biopsy, or will soon have a liver biopsy.
* Have a SPECT scan either before the liver biopsy or 2 weeks to 8 weeks after a liver biopsy.
* Intend to have the SPECT scan within 7 days of study entry.

Exclusion Criteria

Patients will not be eligible for this study if they:

* Are allergic to chemicals in the radioactive tracer used for the SPECT scan.
* Are pregnant or breast-feeding.
Post-Market Observational Study of Intra-Renal Drug Delivery

This is a prospective, observational, multi-center study with consecutive enrollment. Up to 1,000 patients will be enrolled. The objective of this post-marketing surveillance study is to collect clinical usage patterns of the Benephit Infusion Systems. As a result, FlowMedica will be able to:

1. Better understand and quantify usage patterns including patient characteristics, adjunctive procedures, and infusion agents.
2. Collect user-interface information and overall customer satisfaction.
3. Monitor post-marketing device performance.


Eligibility Criteria:
Inclusion Criteria:

* Exposure to one or more components of the Benephit Infusion System
* Ability to give written informed consent

Exclusion Criteria:

* Inclusion in another clinical study that may affect usage of the Benephit system
Spectroscopic Assessment of Intramyocardial Oxygen Saturation During Open-Heart Surgery

The goal of this observational study is to test in the safety and performance of intraoperative myocardial spectroscopic measurement in open-heart surgery patients

The main questions it aims to answer are:

* The Devices can record myocardial spectrometric data for analysis, and
* How these measures correlate with the occurring events, procedures, and clinical parameters during the operation.
* Number of participants with device-related adverse events as assessed by CTCAE v4.0

The study design is based on measuring the depth of ischemia during the operation, which is compared to the intraoperative and postoperative morbidity of the patient, especially to the dysfunction of the heart. A qualified and experienced Monitor is assigned for the study to oversee and document the progress of the trial. The Monitor ensures the trial performance in accordance with the Protocol and Good Clinical Practice (GCP). The trial team conforms to ISO 13485 quality standards and ISO 14155 GCP. Processes included in the monitoring activities are documented in the quality management system. Below are described the summaries of all these activities. Source data will be collected and transferred into the electronic CRFs by site staff, and the collected data quality and the conformity to the Good Clinical Practice will be assessed by monitoring. Based on a risk assessment performed, a Data Monitoring Committee shall not be established. Clinical Research Associate (CRA) is responsible for checking the accuracy and completeness of Case Report Form (CRF) entries, source documents, and other investigation-related records against each other. Other responsibilities of CRA, including detailed Source Data Verification (SDV), are documented by the clinical project manager (CPM) or head of clinical research (HCR)(both are sponsor's representatives). SDVs will be performed and documented during monitoring visits. Monitoring planning, reporting, and visits are pre-defined and documented with pre-made templates per the sponsor's quality management system. Monitoring visits will be performed to cover data from all study participants, and according to QMS and the Standard Operation Procedures. The monitoring shall ensure that all source documentation is precise and document control is exercised in all relevant documentation. The monitoring ensures, that the Adverse events are always reported and appropriate authorities or stakeholders are informed.

Eligibility Criteria:
Inclusion Criteria:

* Any 18 to 90-year-old patient scheduled for an open-heart operation
* The ability to understand the study's objective and the risks involved.
* Informed consent obtained, including the agreement to authorization to use the protected personal patient records according to privacy legislation.

Exclusion Criteria:

* Inability to obtain an informed consent form
* Patients included as vulnerable population according to Finnish Medical Research Act, including retarded, pregnant women, nursing mothers, prisoners, or forensic patients.
A Pharmacodynamics, Pharmacokinetics, and Safety Study of Hydrochlorothiazide and Canagliflozin in Healthy Volunteers

The purpose of the study is to evaluate the effects of multiple doses of hydrochlorothiazide and canagliflozin on the concentrations of each drug in the blood and the concentration of glucose in the blood and urine in healthy adult volunteers.

This is a single-center, open-label study with 2 study periods where volunteers and study staff will know the names and doses of assigned study treatments. All volunteers will receive the same treatment. Canagliflozin (a sodium-glucose cotransporter 2-inhibitor) is currently under development to lower blood sugar levels in patients with Type 2 diabetes mellitus (T2DM), and hydrochlorothiazide (HCTZ) is a drug indicated for the treatment of patients with mild to moderate hypertension. During Period 1, volunteers will take canagliflozin 300 mg once daily for 7 days (Days 1 to 7) and during Period 2, volunteers will take HCTZ 25 mg once daily for 28 days (Days 1 to 28), and then starting on Day 29, will take canagliflozin 300 mg once daily and HCTZ 25 mg once daily for 7 days (Days 29 to 35). Period 1 and Period 2 will be separated by a minimum of 14 days.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers with a body mass index (BMI, a measure of a person's weight in relation to height) between 18 and 30 kg/m2, inclusive, and a body weight of not less than 50 kg

Exclusion Criteria:

* History of or current clinically significant medical illness as determined by the Investigator
* History of clinically significant allergies, especially known hypersensitivity or intolerance to lactose
* Known allergy to canagliflozin or any of the excipients of the formulation of canagliflozin
OUR Stress/ Emotion Management for Black/African American Women With Hypertension

Covid-19 is an additional stressor Black women have to deal with that may interfere with hypertension self-care management. Social connectedness is a source of resilience for Black women to promote mental and physical health. Unfortunately, in the face of the Covid-19 pandemic, social distancing is a challenge further isolating Black women from their networks. How is social connectedness to manage stress and emotional well-being in a social-distancing society for Black women with hypertension? The research team proposed a synchronous web-based version of Enhanced Co-Created Health Education InterventioN (eCo-CHIN) that build the success and best practices derived from the original intervention. A Covid-19 session will be included as a way of helping Black women to maintain resilience and self-care during stressful times. The eCo-CHIN intervention is innovative and timely because the research team are using a synchronous platform preparing Black women on how to deal with Covid-19 while taking care of self. The primary investigator for this pilot study (Dr. Wright) is a Black Early Stage Investigator and former KL2 (career development) awardee. The interdisciplinary research team has the expertise and resources to deliver this Enhanced Co-CHIN intervention.

The rationale for the study is that the adherence to healthy self-care behaviors reduces poor nutrition, altered sleep, sedentary behavior, psychosocial stress, and emotional dysregulation, thereby reducing negative impacts on the brain, since all these factors contribute to neural inflammation and increased BP. Health-promoting self-care behaviors have the known short-term effect of enhanced cognitive function (processing speed, attention, and executive function) through the use of The Repeatable Neuropsychiatric Battery (RBANS) which is also an innovative component of OUR Project. Thirty middle-aged Black women (45-65 years old) with a self-reported diagnosis of hypertension will be enrolled. The development of this group-delivered intervention will be an iterative process, and the research team will use this pilot data to submit an R21 for a 12-week intervention through the National Institutes on Aging.

Eligibility Criteria:
Inclusion Criteria:

* English speaking,
* self-identification as Black/African America
* diagnosis of hypertension (treated with medications and or lifestyle management)
* female sex
* access to a smart phone or a computer capable of connecting to the Internet

Exclusion Criteria:

* no access to computer with internet Smart phone
* diagnosis of resistant hypertension defined as blood pressure that remains above goal despite concurrent use of three antihypertensive agents of different classes, one of which should be a diuretic/water pill.
Evaluation of VDD Leadless Pacing System During Exercise

The study is a non-randomized, active prospective observational study permitting to report the behavior of Micra AV pacemaker during an exercise.

Only patients who were previously implanted with a Micra MC1AVR01 can be enrolled in the study. Exercise test is part of the standard clinical care practice for this patients population during the first year follow-up.

The purpose of this observational study is to obtain additional data on behavior and safety of the Micra MC1AVR01 during exercise:

1. Characterize the atrial detection rate/A4 amplitude by a ventricular Micra AV (Micra MC1AVR01) at rest and during exercise
2. Characterize the AV synchrony percentage provided by the Micra AV during exercise.
3. Confirm the safety of the Micra AV during exercise

Only patients who were previously implanted with a Micra MC1AVR01 can be enrolled in the study. All subjects provide signed and dated consent that he/she is willing and able to comply with the protocol.

Retrospective patients enrollment is allowed to facilitate a more rapid performance assessment in patients previously implanted with a Micra AV for whom an exercise test has already been performed.

Exercise test The Micra AV permits AV synchronous pacing mode up to a maximal sinus rate of 115/min. Exercise test will therefore be performed up to a maximal heart rate of 115/min. The test will be stopped by the patient (depending on his/her ability/symptoms such as: fatigue, dyspnea, leg pain,..) or by the cardiologist if a maximal heart rate of 115 beats per minute is reached.

Eligibility Criteria:
Inclusion Criteria:

* Patients previously implanted with a Micra MC1AVR01
* Signed and dated consent (patient confirms that he/she is willing and able to comply with the protocol)
* Patient is physically able to perform an exercise test (cycle test).

Retrospective patients enrolment is allowed to facilitate a more rapid performance assessment in patients previously implanted with a Micra AV for whom an exercise test has already been performed.

Co-enrolment in the Micra AV post-approvals study is allowed.

Exclusion Criteria:

- Frail patient unable to perform an exercise test (cycle test).
Systemic Sclerosis and Innate T Cells

Innate T cells (ITC) are decreased in systemic sclerosis (SS) and an early lymphocyte innateness has been reported. In the other part, ITC are implicated on inflammatory process, including the IL-33/ST2 axis, which is also involved in ScS endotheliopathy.

Data are however scarce and physiopathological mechanisms have not been assessed to date.

The investigators hypothesize a global lymphocyte innateness in SSc, linked to a chronic ITC stimulation by innate signals leading to ITC exhaustion, and their potential role in endotheliopathy and fibroblast activation in SSc.


Eligibility Criteria:
Inclusion Criteria:

* SSc according to the 2013 ACR/EULAR 2013 criteria (or the 2001 Leroy's criteria for early SSc)
* Patients with others connective tissue disease:

  * Systemic erythematosus lupus (SLE) according to the 2019 ACR/EULAR criteria
  * Primary Sjögren syndrome (pSS) according to the 2016 ACR/EULAR criteria
  * Rheumatoid arthritis according to the 2010 ACR/EULAR criteria
  * Idiopathic inflammatory myopathy (IIM) according to the 2017 ACR/EULAR criteria
* Healthy subjects from general population without known autoimmune disease or connective tissue disease
* ≥18 years-old

Exclusion Criteria:

* Overlap syndrome (including secondary Sjögren syndrome)
* Weight \<55 kgs
* Known primary cell immunodeficiency
* Past of autologous or allogenic hematopoietic stem cell transplantation
* Solid neoplasia or malignant hemopathy in remission for less than 12 months an
* Chemotherapy and/or immune checkpoint inhibitors in the last 12 months
* Systemic retinoids
* Active infection and/or antibiotics in the last 2 weeks
* Known active chronic infection among HIV, HTLV, viral hepatitis, syphilis
* Vaccination in the last 4 weeks
* Subject refusing genetic analysis for the present study
* Pregnancy or breastfeeding