cyrilzakka/clinical-trials huggingface dataset:
A Randomized, Crossover Study to Assess the Effects of Dietary Fiber-containing Bars on Glucose and Insulin Responses

This randomized, crossover study will include four clinic visits: one screening (day -7) and three test visits (days 0, 2, 4). The objective of this study is to assess the effects of dietary fiber-containing bars, at two doses of fiber, compared to a control product, on postprandial glucose and insulin responses in healthy adult men and women.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, 18-65 y of age, inclusive.
* Subject has a body mass index of 18.5 to 32.0 kg/m, inclusive.
* Subject is judged by the Investigator to be in generally good health on the basis of medical history and screening measurements.
* Subject is willing to consume the study products as described in the protocol.
* Subject is willing to maintain usual diet and activity patterns throughout the study.
* Subject has no plans to change smoking or other nicotine use during the study period.
* Subject is willing and able to attend all clinic visits.
* Subject has a vein access scale score of 7-10.
* Subject understands the study procedures and signs forms documenting informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator and is willing to complete study procedures.

Exclusion Criteria:

* Individual has a clinically significant gastrointestinal, endocrine (including Type 1 and Type 2 diabetes mellitus), cardiovascular, renal, hepatic, pulmonary, pancreatic, neurologic, or biliary disorder.
* Subject has pre-diabetes (fasting capillary glucose between 100 and 125 mg/dL) at screening. One re-test on a separate day will be allowed for subjects with no known history of pre-diabetes or diabetes who have a capillary glucose of 100 - 110 mg/dL at screening (visit 1).
* Individual has uncontrolled hypertension (systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm Hg) at screening.
* Individual has a history of cancer in the prior 2 years, except for non-melanoma skin cancer.
* Individual has extreme dietary habits (e.g., Atkins, vegan).
* Individual has had weight change of ±4.5 kg (10 lbs) in the previous 3 months.
* Individual has a known allergy, sensitivity, or intolerance to any ingredients in the study products.
* Individual is a female, who is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to the use of a medically approved form of contraception throughout the study period.
* Individual has been exposed to any non-registered drug product within 30 days of screening.
* Individual has a condition the Investigator believes would interfere with his or her ability to provide informed consent or comply with the study protocol, or which might confound the interpretation of the study results or put the person at undue risk.
A Study to Assess Change in Disease State in Adult Participants With Acute Myeloid Leukemia (AML) Receiving Oral Venetoclax Tablets in Combination With Subcutaneously (SC) or Intravenously (IV) Injected Azacitidine in Colombia

Acute myeloid leukemia (AML) is a cancer of the blood and bone marrow and is the most common acute leukemia in adults. This study will evaluate how well venetoclax in combination with azacitidine works to treat AML in adult participants in Colombia.

Venetoclax in combination with azacytidine is approved to treat Acute myeloid leukemia (AML). All study participants will receive venetoclax in combination with azacitidine as prescribed by their study doctor in accordance with approved local label. Adult participants with a new diagnosis of AML will be enrolled. Around 70 participants will be enrolled in the study in Colombia.

Participants will receive venetoclax tablets to be taken by mouth in combination with azacitidine given by subcutaneous (SC) or intravenous (IV) injection according to the approved local label. The duration of the study is approximately 36 months.

There is expected to be no additional burden for participants in this trial. All study visits will occur during routine clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed acute myeloid leukemia (AML) defined as participants that have histological confirmation of AML (de novo, secondary) by World Health Organization (WHO) criteria, and have not received any prior treatment for AML.
* Ineligible to intensive chemotherapy due to \>=75 years of age; or \>=18 to 74 years who have comorbidities that preclude use of intensive induction chemotherapy.
* Participants starting treatment with venetoclax in combination with azacytidine treated according to the Colombia label and who are not completed the first cycle (Cycle 28 days).

Exclusion Criteria:

- Participating in an interventional clinical trial within 30 days prior to Venetoclax treatment initiation.
Fibrosing ILD Biomarkers That Rule Acceleration

FIBRALUNG is a prospective cohort study with biobank of samples from patients with pulmonary fibrosis, aiming to explore the molecular determinants of different clinical outcomes, acute exacerbations and mortality. We expect to gain deeper insight into fibroproliferative common pathways, particularly between idiopathic pulmonary fibrosis and fibrotic hypersensitivity pneumonitis, paving the way for new biomarkers that reflect the progressive phenotype, that eventually will support new targeted therapies.

Other idiopathic interstitial pneumonias, connective tissue disease-related interstitial lung diseases and sarcoidosis patients will be also recruited and their biological samples stored for further analyses.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged between 18-80 years
* People undergoing blood collection, lung biopsy and/or BAL as part of their diagnostic workup
* Willingness to undergo the follow-up protocol evaluations
* Treatment-naïve for disease-modifying drugs
* An HRCT scan performed within the last 12 months showing ≥10% fibrosis extent of the lungs

Exclusion Criteria:

* People who cannot give informed consent
* Pregnancy
A Study of Controlled-Release Carvedilol Compared to Immediate-Release Carvedilol in Patients With Primary Hypertension

The purpose of this study is to compare the efficacy of the Egalet® controlled release formulation to an immediate release Carvedilol tablet.


Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of mild or moderate primary hypertension
* Be able to tolerate a 2 week washout phase followed by a 2 week Placebo run- in phase
* Be minimum 18 years of age

Exclusion Criteria:

* Be intolerant to alfa- or beta-blockers
* Have secondary causes of hypertension
* Be taking more than two antihypertensive medications
Pharmacogenetic Prediction of Metoprolol Effectiveness

The investigators will prospectively follow a population of patients with uncontrolled high blood pressure beginning metoprolol succinate therapy to determine the drug effect in an observational clinical trial. The investigators will determine each individual's genotype for both CYP2D6 and Adrenoceptor Beta 1 (ADRB1). Metabolomic markers will be identified to determine if specific metabolites are associated with drug response. The investigators' overall objective is to determine if genetics predicts metoprolol succinate response better than clinical factors such as age, race, body mass index, dose, and medication co-ingestion.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects between age \>30 years and \< 80 years
2. Subjects have diagnosis of uncontrolled essential hypertension.

Exclusion Criteria:

1. end stage liver disease,
2. end stage renal disease,
3. pregnant females,
4. American Society of Anesthesiologists (ASA) classification of \>3,
5. wards of the state, prisoners,
6. decisionally challenged,
7. HR\<60 bpm,
8. AV block\>240 msec,
9. active reactive airway disease,
10. illicit drug abuse in the preceding 30 days,
11. hypersensitivity to metoprolol or its derivatives
12. severe peripheral arterial circulatory disorders.

Subjects will have a screening physical exam performed by Dr. Monte prior to enrollment in the study.
Resveratrol and First-degree Relatives of Type 2 Diabetic Patients

The main objective of the study is to investigate if resveratrol supplementation can improve overall and muscle-specific insulin sensitivity in first-degree relatives of type 2 diabetic patients.

As a secondary objective the investigators want to investigate whether the improved insulin sensitivity can be attributed to improved muscle mitochondrial oxidative capacity and a reduced intrahepatic and cardiac lipid content. Furthermore, in a subset of the participants the investigators want to investigate the effect of resveratrol on glucose uptake in brown adipose tissue.


Eligibility Criteria:
Inclusion Criteria:

* Male sex
* Age: 40-70 years
* BMI 27-35 kg/m2
* Has first-degree relative(s) diagnosed with type 2 diabetes
* Sedentary
* Not more than 2 hours of sports a week
* No active job that requires strenuous physical activity
* Stable dietary habits: no weight gain or loss \> 5kg in the last three months
* Insulin resistant: glucose clearance rate below \< 350 ml/kg/min, as determined using OGIS120
* Willingness to abstain from resveratrol-containing food products
* Subjects will only be included when the dependent medical doctor of this study approves participation after evaluating data obtained during screening

Exclusion Criteria:

* Use of anticoagulants
* Uncontrolled hypertension
* Haemoglobin \<7.8 mmol/l
* In case of an abnormal ECG in rest: this will be discussed with the responsible medical doctor
* HBA1C \> 6.5%
* Diagnosed with type 2 diabetes
* Medication use known to interfere with glucose homeostasis/metabolism
* Current alcohol consumption \> 20 grams/day
* Subjects who don't want to be informed about unexpected medical findings during the screening /study, or do not wish that their physician is informed, cannot participate in the study.
* Subjects who intend to donate blood during the intervention or subjects who have donated blood less than three months before the start of the intervention.
* Participation in another biomedical study within 1 month before the first screening visit
* Any condition, disease or abnormal laboratory test result that, in the opinion of the Investigator, would interfere with the study outcome, affect trial participation or put the subject at undue risk
* Any contra-indication to MRI scanning. These contra-indications include patients with following devices:

  * Central nervous system aneurysm clip
  * Implanted neural stimulator
  * Implanted cardiac pacemaker of defibrillator
  * Cochlear implant
  * Insulin pump
  * Metal containing corpora aliena in the eye or brains
Safety and Efficacy of Chimeric Antigen Receptor T Lymphocytes for Patients With Intermediate and Advanced Tumors

This was a single arm, open-label, single center, cohort study to determine the efficacy and safety of AMT-116 CAR-T cells in patients with moderate or far advanced non-small cell lung carcinoma (NSCLC) and squamous cell cancer of the head and neck (HNSCC)，AMT-253 CAR-T cells in patients with moderate or far advanced melanoma.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-70 years old, both men and women, and the survival period is more than 6 months.
* At least one assessable focus, failure of previous multi-line treatment or stable condition after treatment.
* Patients with melanoma confirmed by histopathology, patients with non-small cell lung cancer(squamous carcinoma) and head and neck squamous cell carcinoma.
* The surgically removed pathological tissue can be used for immunohistochemical detection of target protein (paraffin section should be within 5 years), and the positive expression of target protein in line with pathological diagnosis (immunohistochemical staining + + or + + +).
* Sufficient venous access for blood sampling and venous blood sampling, no contraindications for lymphocyte collection.
* Routine blood examination: white blood cell count (WBC) ≥ 3 × 10\^9 / L, lymphocyte count (ly) ≥ 0.8 × 10\^9 / L, hemoglobin (HB) ≥ 90g / L, platelet (PLT) ≥ 80 × 10\^9/L.
* Liver and kidney function: alanine aminotransferase and aspartate aminotransferase \< 3 ULN, total bilirubin (TBIL) \< 1.5 ULN, serum creatinine (SCR) \< 2 ULN.
* The subjects voluntarily joined the study, signed the informed consent form, had good compliance and cooperated with the follow-up.

Exclusion Criteria:

* Active hepatitis B or hepatitis C virus, HIV infection, or other unhealed active infections.
* Patients with second tumor.
* Patients previously treated with car-t cells.
* Requiring long-term use of immunosuppressants for any reason.
* Any serious and uncontrolled systemic autoimmune disease or any unstable systemic disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, ulcerative colitis, Crohn's disease and temporal arteritis.
* Subjects with severe heart, lung, liver and kidney dysfunction or severe lung diseases.
* Current systemic use of steroid cells (except for recent or current use of inhaled steroids).
* Pregnant and lactating subjects.
* Allergic to immunotherapy and related cells.
* Subjects with a history of organ transplantation or waiting for organ transplantation.
* After evaluation, the investigator considered that the subjects were unable or unwilling to comply with the requirements of the study protocol.
Evaluating Airway Sarcoidosis Pathology With MRI

Sarcoidosis is a condition where inflamed cells clump together to form granulomas, which can lead to inflammation or scarring. It can affect any organ of the body, but most commonly affects the lungs. Symptoms can be highly variable, and some patients have no symptoms where as others may develop fatigue or breathlessness. The causes of sarcoidosis are poorly understood. It commonly affects adults in their 30's or 40's.

Some patients present with symptoms suggestive of involvement in the airways, such as cough. Inhalers containing steroid are commonly used, but there is a poor understanding of which patients may benefit. Part of the problem is the lack of a sensitive way of measuring these effects and knowledge of how sarcoidosis affects the airways physiologically.

The investigators would like to know more about the disease process of sarcoidosis, particularly where it involves the airways. This study will use a number of techniques in order to better understand to disease process.

In order to assess whether sarcoidosis produces changes in airway ventilation (and whether these changes are stable or change over a short time period). This pilot study aims to recruit 6 patients who will have magnetic resonance imaging (MRI) with inhaled xenon gas. During this technique, xenon and nitrogen mixture is inhaled and during a subsequent breath-hold, images of the lungs are taken. This creates a detailed view of the lung airway tree, to explore how the disease affects the airways and deeper lung tissue.

This technique will be used alongside lung function tests, commonly performed in the laboratory setting and cardiopulmonary exercise testing, to see what happens in the lungs of this group of patients when they reach peak exercise capacity.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of sarcoidosis
* Sarcoidosis clinician diagnoses airways involvement
* Aged 18 and above

Exclusion Criteria:

* Current combustible cigarette or electronic cigarette user
* Significant doubt over the diagnosis of sarcoidosis
* Asthma or other airways disease, requiring regular inhaler use
* Contraindication to MRI identified on safety questionnaire
* Recent COVID-19 infection (lateral flow or PCR swab positive within the last 28 days) or ongoing symptoms from COVID-19
Prevalence of Cesarean Section on Demand in Assiut University Hospital & Abnob Central Hospital

Cesarean section on demand: defined as a primary cesarean section performed at the mother's request to avoid a vaginal birth, without any recognized medical or obstetric indication. The medical field now acknowledges a patient's right to actively participate in her choice of medical treatments, including method of delivery.

There are many reasons for a cesarean section on demand: fear of delivery, fear of pain, family pressure, a previous bad experience, more control over events, improved care, and maintaining the integrity of the pelvic floor. of the pelvic floor.


Eligibility Criteria:
Inclusion Criteria:

* Accepting to participate in the study.
* pregnant Women undergoing Cesarean section

Exclusion Criteria:

* pregnant Women undergoing Cesarean section due to medical or obstetric indication
* Caesarean hysterectomy .
Study Evaluating Flexitouch Plus With Connectivity on Compliance in 30 Patients With Breast Cancer-Related Lymphedema.

The objective of this study is to demonstrate the feasibility of using the Flexitouch Plus with Cellular Connectivity (FT-CC) to monitor device use data to determine if reminders to patients impact compliance, and to identify the impact device compliance has on arm girth, quality of life (QOL), and symptom assessment.

This is a multi-center, on label, prospective, randomized, two-arm feasibility study that plans to enroll 30 female subjects in the United States. In an effort to reduce potential exposure to COVID-19, all study assessments are intended to be performed in a contactless manner (i.e., telephone, video conference, etc). If a subject passes the initial screening requirements via medical history and expresses interest in the study an informed consent form will be provided to them. Once consent has been obtained they will undergo a baseline visit where they will be randomized to one of two treatment groups: PASSIVE FT-CC (text messages reminders will not be sent to subjects) and ACTIVE FT-CC (text messages reminders will be sent if subject does not use the device for 2 consecutive days). Randomization was incorporated into the study to determine if ACTIVE FT-CC affects device use. A total of 2 follow-up visits will be conducted over a 60-day period.

Eligibility Criteria:
Inclusion Criteria:

1. Female 18 years of age or older
2. Diagnosis of unilateral breast cancer-related lymphedema
3. Willing and able to give informed consent (remotely or in person)
4. Willing and able to comply with the study protocol requirements and all study-related visit requirements, including the ability to participate remotely
5. Willing and able to receive text messages from sponsor

Exclusion Criteria:

1. In-home use of PCD within previous 3 months
2. Phase-one CDT within previous 1 month or planned phase-one CDT during study participation Phase-one CDT defined as professionally administered MLD and/or multi-layer short stretch compressive bandaging.
3. Inability to be fit for PCD garments
4. Heart failure (acute pulmonary edema, decompensated acute heart failure)
5. Acute venous disease (acute thrombophlebitis, acute deep venous thrombosis, acute pulmonary embolism)
6. Active skin or limb infection/inflammatory disease (acute cellulitis, other uncontrolled skin or untreated inflammatory skin disease) on the arms or trunk
7. Currently receiving treatment for cancer with curative intent.
8. Any circumstance where increased lymphatic or venous return is undesirable
9. Currently pregnant or trying to become pregnant
10. Known inability to receive cell phone connection where FT-CC therapy will be administered
Efficacy, Safety and Pharmacokinetics of Artemether-lumefantrine Dispersible Tablet in the Treatment of Malaria in Infants < 5 kg

The purpose of the study is to obtain efficacy, safety and pharmacokinetic (PK) data following treatment with artemether-lumefantrine dispersible tablet in infants \< 5 kg of body weight (BW) with uncomplicated falciparum malaria.


Eligibility Criteria:
Inclusion Criteria:

* Neonates / infants
* Body weight \< 5 kg
* In cohort 1, infants aged \> 28 days; in cohort 2, neonates of a term age 0 to ≤ 28 days
* Microscopically confirmed diagnosis of acute uncomplicated Plasmodium falciparum malaria or mixed infections with an asexual Plasmodium falciparum parasitaemia of \> 1,000 and \< 100,000 parasites/µL

Exclusion Criteria:

* Presence of severe malaria (according to World Health Organization definition)
* Presence of the following signs of a critical condition: apnea-bradycardia, sustained bradycardia, tachycardia, desaturation, hypotension, hypothermia; or other severely deteriorated general condition (based on IMCI criteria in sick infants)
* Presence of any clinically significant neurological condition
* Presence of clinically significant abnormality of the hepatic and renal systems
* Patients who sustained a significant blood volume loss (\> 3% of calculated blood volume) in the past 30 days
* Patients unable to swallow or whose drinking is impaired
* Family history of congenital prolongation of the QTc interval or sudden death or with any other clinical condition known to be associated with prolongation of the QTc interval such as history of symptomatic cardiac arrhythmias, with clinically relevant bradycardia or with severe cardiac disease
* Disturbances of electrolyte balance (e.g. hypokalaemia or hypomagnesaemia)
* Presence of any age-adjusted clinically or hematologically relevant laboratory and blood chemistry abnormalities
* Other protocol-defined inclusion/exclusion criteria may apply.