cyrilzakka/clinical-trials huggingface dataset:
Study to Evaluate the Effect of Multiple-Dose Ritlecitinib on the Pharmacokinetics (PK) of Tolbutamide

This is a Phase 1, 2-period, multiple-dose, open-label, single fixed sequence study of the effect of ritlecitinib on tolbutamide pharmacokinetics in healthy participants.

A total of approximately 12 healthy male and/or female participants will be enrolled in the study to obtain at least 10 evaluable participants who complete the study. This is an open-label study not requiring an assessment of efficacy or pharmacodynamics markers, but it will include pharmacokinetic estimation drug-drug interactions.

Eligibility Criteria:
Inclusion Criteria:

* Male and/or female participants who are healthy as determined by medical evaluation including medical history, full physical examination (including BP and pulse rate measurements), clinical laboratory tests, and 12-lead ECG.
* BMI of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lb).

Exclusion Criteria:

* Past/present clinically significant hematological, renal, endocrine, pulmonary, GI, CV, hepatic, psychiatric, neurological, dermatological or allergic disease (including drug allergies).
* Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).
* Infection with hepatitis B or C viruses.
* Participants with any of the following acute or chronic infections or infection history: any infection requiring treatment within 2 weeks prior to the start of study participation; any infection requiring hospitalization or parenteral antimicrobial therapy within 60 days of the first dose of investigational product; any infection judged to be an opportunistic infection or clinically significant within the past 6 months of the first dose of investigational product; known active or history of recurrent bacterial, viral, fungal, mycobacterial or other infections; history of recurrent localized dermatomal herpes zoster, or history of disseminated (single episode) herpes simplex or disseminated herpes zoster.
* History of any lymphoproliferative disorder such as EBV related lymphoproliferative disorder, history of lymphoma, history of leukemia, or signs or symptoms suggestive of current lymphatic or lymphoid disease.
* Known presence or a history of malignancy other than a successfully treated or excised non-metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ.
Effect of Optimal Positive End-Expiratory Pressure on Oxygenation and Intrapulmonary Shunt During One-lung Ventilation

To observe the effect of compliance guided an optimal Positive End-Expiratory Pressure（PEEP）on arterial oxygenation and intrapulmonary shunt during one-lung ventilation(OLV)，and discuss the lung protective effect of optimal PEEP during one-lung ventilation.

Sixty patients undergoing thoracic surgery were randomly allocated to the study or control group.Patients were monitored for electrocardiogram, pulse oximetry, and non-invasive blood pressure,20 gauge cannula needle for radial artery catheterization under local anesthesia, monitoring ABP.,the right subclavian vein was selected for catheterization under local anesthesia,monitoring CVP.Anesthesia was induced with sufentanil 0.4 μg/kg, propofol 2 mg/kg, and cisatracurium 0.3 mg/kg.The trachea was intubated with a double-lumen tube (DLT)，37F for male and 35F for female patients.Tube position was confirmed by bronchoscopy in the supine and lateral positions.Anesthesia was maintained with sevoﬂurane 1.0-1.5 vol%，propofol 2-4 mg/(kg·h) and remifentanil 0.1-0.2 μg/(kg·min) and intermittent cisatracurium 0.06-0.1 mg/kg.The lungs were initially ventilated using a volume-controlled ventilation mode,two-lung ventilation(TLV):tidal volume (VT) 8 ml/kg,respiratory rate 12-14 bpm, inspiratory:expiratory (I:E) ratio 1:2, in 60% oxygen without PEEP. During OLV, VT was reduced to 6 ml/kg,OLV was initiated at the moment of skin incision.Both groups received an alveolar recruitment maneuver(increase inspiratory pressure to 30cmH2O for 10s) at the 10min after one-lung ventilation. After the alveolar recruitment maneuver,the study group titrate PEEP from 4cmH2O,increased in 2cmH2O steps and hold at each step for 1min,and the static pulmonary compliance(Cst) would be record.Optimal PEEP was determined until the maximal static pulmonary compliance was obtained.In the control group at PEEP level of 5 cmH2O was established and maintained during the study period.Blood gas analyses, respiratory variables, and hemodynamic variables were recorded at 6 different time points:10 min after TLV(T0), 10min after OLV(T1), 30min after PEEP(T2), 60min after PEEP(T3), 10min after the end OLV(T4) and 20min after extubation(T5).

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 yr to 65 yr
* Body mass index(BMI)18-28kg/m2
* American Society of Anesthesiologists Physical Status Classifications I to II
* Normal cardiac and pulmonary function
* Diagnosed with uncomplicated lung cancer and was to receive video-assist thoracoscopic lobectomy under general anesthesia.

Exclusion Criteria:

* Forced expiratory volume at one second/forced vital capacity \<70%
* Asthma
* Chronic obstructive pulmonary disease
* Acute lung infection
* Past history of thoracic surgery
* Cardiac,hepatic,renal and endocrine diseases
* Preoperative glucocorticoid medication
* Preoperative chemotherapy
* Peripheral oxygen saturation（SpO2） kept below 90% for more than 10 minutes during operation
* Blood transfusion during operation
* Duration of one-lung ventilation less than an hour
* Occurrence of severe complications like allergic shock
Effects of Education Program for Lebanese Diabetic T2 in Their Behavior of Auto Managing, of Self-efficacy and Adhesion

Diabetes mellitus is a disease of great frequency and is a major public health problem. In Lebanon, the incidence of diabetes is estimated at 12%, it is expected to double by the year 2025. Given the increasing prevalence of diabetes in Lebanon, the evolution of complications of this disease and the lack of studies at this level, it is appropriate to conduct a study that aims to evaluate the effects an education program for people with type 2 diabetes on their sense of self-efficacy and their ability to self-manage their disease to make them the most optimal therapeutic adherence possible. The design of this study is experimental type before / after randomization by diabetic patients. Education program delivered to the experimental group is the "Accu-Chek Education Program" of Roche. Membership will be assessed using a biomarker HbA1c should be \<7%, and a questionnaire (Summary of Diabetes Self-Care Activities Measure), which measures self-care behaviors. Self-efficacy is measured using the Diabetes Management Self-Efficacy Scale. And this before the intervention and 3 months later. The sample will be 240 diabetic patients T2. Recruitment will be in outpatient diabetology a Hospital located in Beirut. Statistical analyzes used for descriptive variables are measures of central tendency, dispersion and frequency distribution. T-test and chi-square will be used to compare the socio-demographic characteristics of the 2 groups, experimental and control. To test hypotheses and determine the difference in the results of the dependent variables of the 2 groups, analysis of variance and covariance are used. The data will be processed using SPSS version 14.0.

1. Following the implementation of a program of education, feeling of self-efficacy participants will be higher in the experimental group than in the control group.
2. Following the implementation of a program of education, self-management behaviors: monitoring the diet, the practice of physical exercise, self-monitoring blood sugar, taking medications and care feet, participants will be higher in the experimental group than in the control group.
3. Following the implementation of a program of education, the percentage of participants who have an HbA1c less than 7 will be higher in the experimental group than in the control group.

Eligibility Criteria:
Inclusion Criteria:

* 18 years and over,
* Suffering from type 2 diabetes for at least one year,
* Lebanese speak, read and write Arabic,
* Have an HbA1c ≥ 7%

Exclusion Criteria:

* mental impairment
* a psychological problem uncontrolled and medicated
Pharmacokinetic Study of Alpelisib in Subjects With Hepatic Impairment.

To characterize the pharmacokinetics and safety of alpelisib in subjects with hepatic impairment compared to matched healthy control subjects.


Eligibility Criteria:
Inclusion Criteria:

-Other then hepatic impairment, subjects should be in good health as determined by past medical history, physical examination, vital signs, electrocardiogram (except for additional inclusion criteria for hepatic impaired subjects). -Subjects must weigh at least 50 kg and no more than 120 kg and have a body mass index in the range 18.0-36.0 kg/m2.

Additional criteria for hepatic impaired subjects: -Subjects must have a score clinically determined and calculated as per the Child-Pugh classification and consistent with the degree of hepatic impairment in which study is currently enrolling. -Stable Child-Pugh status within 28 days prior to dosing.

Exclusion Criteria: All subjects:

* Subject has received a liver transplant at any time in the past and is on immunosuppressant therapy.
* Smokers not willing to limit the use of tobacco to 10 cigarettes per day. -Surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the subject's safety in case of participation in the study. -Use of any herbal medications/supplements.

History of acute pancreatitis within 1 year of study entry.

Additional criteria for subjects with normal liver function:

-Use of any prescription or non-prescription medication. -Positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.

Additional criteria for hepatic impaired subjects: -Use of any prescription or non-prescription medication, that has the potential to interact with alpelisb. Concomitant medications without potential to interact with alpelisib must be stable in dose. -Encephalopathy grade 3 or worse. -Total bilirubin \> 6 mg/dl. Screening or baseline ECG: QTcF\>480msec for both genders

Other protocol-defined inclusion/exclusion criteria may apply.
Primary Anatomical Versus Primary Electrophysiological Approach in Circumferential Pulmonary Vein Ablation

Randomized comparison between 2 techniques of circumferential pulmonary vein ablation in paroxysmal atrial fibrillation: Primary anatomical ablation with secondary closure of possible electrical gaps versus primary electrophysiological ablation at the sites of atrio-venous electrical breakthroughs with secondary circumferential ablation around the pulmonary vein orifice


Eligibility Criteria:
Inclusion Criteria:

* paroxysmal atrial fibrillation
* age over 18 years

Exclusion Criteria:

* persistent atrial fibrillation
* reversible cause of atrial fibrillation
* inability to comply with follow-up
Aerobic Endurance Training vs. Relaxation Training in Patients With Migraine

This is a single centre, open label, prospective, randomized study on the prophylactic effect of moderate aerobic endurance training versus relaxation training in patients with migraine.


Eligibility Criteria:
Inclusion Criteria:

* Patient's signature on the informed consent document \[each patient should be given ample time to read (or have read to them) the consent form, ask any questions they may have regarding the trial and have a clear understanding of the trial and the procedures involved prior to the signing of the consent form\].
* Patients have a clinical diagnosis of migraine with or without aura according to IHS criteria at least one year prior to enrollment.
* Patients have a clinical diagnosis of migraine with or without aura and in addition a clinical diagnosis of tension type headache according to IHS criteria, if patients are able to differentiate between the two headache diagnoses and if migraine is more frequent in these patients
* Patients that report at least three headache days per month

Exclusion Criteria:

* Diseases or disabilities that disqualify to perform either aerobic endurance training or relaxation training
* Language difficulties that disable to fill out questionnaires
* Pregnancy
* Additional diagnosis of secondary headache according to the IHS criteria
DERMALIX Efficacy on Diabetic Foot Ulcers

(DERMALIX) (Patent number: PCT/TR2014/000251) is a bioactive wound dressing that was developed by Ege University School of Pharmacy Department of Pharmaceutical Technology. This dressing has been categorised as Class III medical device. This clinical study will be conducted in patients with diabetic foot ulcers.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 or 2 Patients diagnosed with diabetic foot ulcers
* Class I and II according to Wagner classification
* No infections confirmed with culture test
* No osteomyelitis and gangrene in the foot
* HbA1c values ≤ % 7.5
* Not active smoker
* No planned treatment of hyperbaric oxygen
* Patients who give consent for the study

Exclusion Criteria:

* Patients with diabetic foot ulcer of class 3,4 and 5 according to Wagner classification
* Patients who are pregnant or breast-feeding or female who are in reproductive age applying no preservative method
* Patients who have mental conditions that lead to difficulties in comprehension
* Patients who may have compliance issues
* Patients who have been included to another interventional study with drug or medical device
Evaluation of an Karajishi Contour Investigational Blood Glucose Monitoring System (ISO/FDA Study)

The purpose of this study was to determine if untrained persons with diabetes and without diabetes could operate the Investigational Blood Glucose Monitoring System (BGMS) and obtain valid blood glucose results.


Eligibility Criteria:
Inclusion Criteria:

* Males and females, 18 years of age and older
* Able to speak, read, and understand English
* Willing to complete all study procedures

Exclusion Criteria:

* Hemophilia or any other bleeding disorder
* Pregnancy
* Physical, visual, or neurological impairments that would make the person unable to perform testing with the BGM
* Previously participated in a BG monitor study using the Karajishi Contour BGMS (or used a Bayer Contour meter)
* Work for a medical laboratory, hospital, or other clinical setting that involves training on and clinical use of blood glucose monitors
* Work for a competitive medical device company, or having an immediate family member who works for such a company
* A condition which, in the opinion of the investigator or designee, would put the person or study conduct at risk

General enrollment guidelines:

* Most subjects will be persons with type 1 or type 2 diabetes
* At least 10% of subjects with diabetes will have type 1 diabetes
* Approximately 10% of subjects will be persons without diabetes
* At least 60% of subjects will be younger than age 65
Orthopaedic Specimen Pathology and Early Diagnosis of ATTR Cardiopathy (ATTR-ORTHO)

The goal of this observational study is to learn about the frequency of ATTR amyloid, cardiac involvement and associated features, in 150 patients aged 50 or more years, and operated for an idiopathic carpal tunnel syndrome, lumbar spine stenosis or total hip or knee arthroplasty for primary osteoarthritis. The main questions to be answered are:

1. What is the frequency of ATTR deposits in samples retrieved during surgery?
2. What is the frequency of cardiac involvement in ATTR positive patients?
3. What are the preoperative predictors of ATTR deposits? Participants will

   * have operative samples stained by Congo red in search of amyloid, which will be typed by immunochemistry in positive samples,
   * undergo a multimodal imaging search for cardiac involvement, if ATTR is identified,
   * undergo a preoperative complete clinical examination, including collection of medical history, ECG, biochemical tests, and imaging (ultrasound scans of rotator cuff and hip capsule in all participating patients, of the carpal tunnel in patients operated at this site, and MRI + standing profile radiography of the lumbar spine, in patients operated for lumbar stenosis)
   * ATTR positive patients will be proposed to be followed-up by a reference center, with the aim of an early diagnosis of cardiac involvement, allowing efficient mamagement.

Researchers will assess the frequency of ATTR deposits at each operated site, the frequency or ATTR cardiopathy in ATTR + patients, and will compare demographic, clinical, biochemical, and imaging features in patients with and without ATTR deposits, to guide the indications of pathological examination during these frequent orthopedic surgeries


Eligibility Criteria:
Inclusion Criteria:

1. patients aged 50 or over
2. having signed an informed consent form
3. undergoing surgery for

   1. idiopathic carpal tunnel syndrome
   2. or lumbar spinal canal stenosis
   3. or prosthetic replacement of a hip or knee for primary osteoarthritis

Exclusion Criteria:

1. secondary carpal tunnel syndrome (inflammatory rheumatism, diabetes, hypothyroidism, etc.)
2. Indication of prosthesis for a condition other than primary osteoarthritis.
3. Known amyloidosis
4. Refusal of consent
5. Inability to understand the study
6. Age \< 50 years
Closed Suction Drain vs no Drain on Symptomatic Seroma Formation After Laparoscopic Inguinal Hernia Repair

The current study aims to determine whether a use of closed suction drain following laparoscopic inguinal hernia surgery performed for an inguinoscrotal variety can decrease the incidence of symptomatic seroma formation requiring interventions and thus, prevent postoperative morbidity.

Patients with laparoscopic inguinal repair, TEP as well as TAPP approach, which matches the inclusion criteria will be randomized intraoperatively, based on a complete assessment of eligibility, just before the mesh placement.

Patients recruited in closed suction drain arm will receive suction drain(14 French sizes) in preperitoneal space via a separate incision. The patients without drain arm, the regular postoperative course will be followed.

The drain will be removed once the output falls below 50 ml per day. Both groups will be followed up until three months post-surgery.

Clinical suspicion of seroma in symptomatic patients will be confirmed by ultrasound. Seroma will be managed conservatively till three weeks in the post-op period.

Eligibility Criteria:
Inclusion Criteria:

All patients having an inguinoscrotal hernia (complete type)

Exclusion Criteria:

Obstructed, incarcerated or strangulated hernia Patients unwilling to participate
Activity of Chronic Inflammation in PCOS

Chronic inflammation in polycystic ovary syndrome (PCOS) may be the result of dysregulation of cytokine production (due to insulin resistance, excess visceral fat and hyperandrogenemia), i.e., overproduction of pro-inflammatory factors (e.g. TNF, IL-1, IL-6) in relation to anti-inflammatory ones (IL-10). This condition may be an important link between obesity and insulin resistance, which is crucial in the etiopathogenesis of the syndrome. However, it is not known whether it results from the tendency to accumulate adipose tissue or is a feature of the syndrome itself. There is no data indicating the relationship between chronic inflammation and the severity of metabolic disorders and the value of ovarian reserve in women with various PCOS phenotypes.

The study population will be characterized in terms of demographic (age, BMI), gynaecological (cycle length, menstrual pain, abnormal uterine bleeding) and obstetrics (pregnancies, childbirth, miscarriages) data. PCOS syndrome (and its phenotypes: A, B, C, D) will be recognized by the Rotterdam criteria. During hospitalization, blood samples will be collected for scheduled analyses (20 ml of blood in total).

Eligibility Criteria:
Inclusion Criteria:

* age 18-45 years
* PCOS syndrome confirmed by the Rotterdam criteria

Exclusion Criteria:

* absence of at least one ovary
* diagnosed and/or treated other metabolic disease
* diagnosed and/or treated other endocrine disease
Immunogenicity of an Inactivated COVID-19 Vaccine

This study is an open phase 4 clinical trial of an inactivated COVID-19 vaccine (CoronaVac) manufactured by Sinovac Research and Development Co., Ltd. The purpose of this study is to evaluate the immunogenicity of the CoronaVac in healthy children aged 3-11 years old.

This study is an open phase 4 clinical trial to evaluate the immunogenicity of an inactivated COVID-19 vaccine(CoronaVac)in healthy children aged 3-11 years old.A total of 400 healthy subjects who have received two doses of inactivated COVID-19 vaccine(CoronaVac) manufactured by Sinovac Research \& Development Co., Ltd and is currently 28-42 days after the second dose will be enrolled, including 200 subjects aged 3-5 years and 200 subjects aged 6-11 years old.All of subjects will be collected 3ml venous blood to evaluate the immunogenicity of the CoronaVac.

Eligibility Criteria:
Inclusion Criteria:

* Have received two doses of inactivated COVID-19 vaccine(CoronaVac) manufactured by Sinovac Research \& Development Co., Ltd and is currently 28-42 days after the second dose;
* The subjects and/or guardians can understand and voluntarily sign the informed consent form (for subjects aged 8 years, both subjects and guardians need to sign the informed consent form);
* The subjects and their legal guardians voluntarily participate the study and comply with the study procedure to collect 3ml venous blood;
* Proven legal identity.

Exclusion Criteria:

* Haven't received two doses of inactivated COVID-19 vaccine(CoronaVac);
* Have received COVID-19 vaccines from other manufacturers;
* The interval between blood collection and the second dose is less than 28 days or more than 42 days;
* The subjets and their legal guardians can't cooperate to complete 3ml venous blood collection.
* According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.
Pharmacokinetics Of Sildenafil Orally Disintegrating Tablet Formulation Versus To Viagra® Oral Tablet.

This study will evaluate if an orally disintegrating tablet of sildenafil will have similar pharmacokinetic properties as the conventional tablet of sildenafil.


Eligibility Criteria:
Inclusion Criteria:

* Otherwise healthy male subjects age 45 years or older with or without erectile dysfunction.

Body Mass Index (BMI) of 17.5 to 32.5 kg/m2.

Signed and dated informed consent document.

Exclusion Criteria:

* Evidence or history of clinically significant abnormalities
* Have baseline orthostatic hypotension
* Positive drug screen, excessive alcohol and tobacco use