cyrilzakka/clinical-trials huggingface dataset:
Egypt Hypertension Study

This study is an epidemiological non-interventional trial that aims to evaluate standard daily practice in managing patients with arterial hypertension. The trial only records real-life clinical practice with no additional diagnostic or monitoring procedures.

The study is purposed to collect the following Egypt-specific epidemiology data on hypertension: demographic data, patients' characteristics, and patients' management/treatment in order to reach its rationale.

This study is aimed to evaluate response rate of the antihypertensive treatment with Thiazide Diuretics, calcium antagonist, Angiotensin Converting enzyme Inhibitor, Angiotensin II receptor blocker, and Beta Blocker in real life practice, and to collect the following Egypt-specific epidemiology data on hypertensive patients: demographic data, patents characteristics, and patients' management/treatment.

Approximately 300 sites will be participating (1 investigator per site; 300 investigators). Patients that are to be enrolled will either be newly diagnosed with hypertension, or on current antihypertensive treatment, compiling a total of 3000 patients (21 years, or older). The study will be conducted in two sequential phases; the first phase will include 150 sites from Cairo, Giza and Alexandria aiming to reach 1500 patients followed by a second phase which will include 150 sites from Delta and Upper Egypt aiming to reach 1500 patients. Epidemiological data collection will take place at a single visit and Laboratory Investigations will be requested in the first visit. Patients will be followed for 3 visits with the investigator. The investigator will complete a Patient Record Form (PRF) with the patient's data: demographics, history, current antihypertensive drug treatment/treatment changes, results of physical examination, blood pressure (SBP/DBP), heart rate.

Eligibility Criteria:
Inclusion Criteria:

* Males or female aged \>21 years
* Subject population with newly diagnosed essential arterial hypertension
* Subject population with essential arterial hypertension currently receiving treatment with any of the following antihypertensive classes: a Thiazide Diuretics, calcium antagonist, Angiotensin Converting enzyme Inhibitor, Angiotensin II receptor blocker and Beta Blocker for at least 3 months.
* Females of childbearing potential must use a reliable method of contraception.
* Subject willing to give written informed consent

Exclusion Criteria:

* If participating in any clinical trial, the subject cannot take part in this study.
* Pregnancy and lactation.
* Patients not willing to give Informed Consent.
Clinical Trial to Assess the Pharmacokinetic Characteristics of Lodivixx Tab. 5/160mg in Healthy Male Subjects

To assess the pharmacokinetic characteristics of Lodivixx tab.5/160mg in healthy male subjects

* PK parameter evaluation
* Safety profile evaluation


Eligibility Criteria:
Inclusion Criteria:

* Years 20-45
* Body weight ≥ 50kg and 18 ≤ BMI ≤ 29kg/m2
* volunteer

Exclusion Criteria:

* Subject with serious active cardiovascular, respiratory, hepatologic, renal, hematologic, gastrointestinal, immunologic, dermal, neurologic, or psychological disease or history of such disease
* Subject with symptoms of acute disease within 28days prior to study medication dosing
* Subject with known for history which affect on the absorption, distribution, metabolism or excretion of drug
* Subject with clinically significant active chronic disease
* Subject with any of the following conditions in laboratory test i. AST(sGOT) or ALT(sGPT) \> Upper normal limit × 1.5 ii. Total bilirubin \> Upper normal limit × 1.5 iii. renal failure with Creatinine clearance \< 50mL/min
* Clinically significant hypotension when screening period (SBP \< 100mmHg, DBP \< 60mmHg)
* Positive test results for HBs Ab, HCV Ab, Syphilis regain test
* Use of any prescription medication within 14 days prior to study medication dosing
* Use of any medication such as over-the-counter medication including oriental medication within 7 days prior to study medication dosing
* Subject with clinically significant allergic disease (except for mild allergic rhinitis and mild allergic dermatitis that are not needed to administer drug)
* Subject with known for hypersensitivity reaction to S-amlodipine, amlodipine and valsartan and dihydropyridine derivatives
* Subject who is not able to taking the institutional standard meal
* Subjects with whole blood donation within 60days, component blood donation within 20days
* Subjects receiving blood transfusion within 30days prior to study medication dosing
* Participation in any clinical investigation within 60days prior to study medication dosing
* Continued excessive use of caffeine (caffeine \> five cups/day), alcohol(alcohol\>30g/day) and severe heavy smoker (cigarette \> 10 cigarettes per day)
* Subject who has been taken meal which affect on the absorption, distribution, metabolism, excretion of drug, especially grapefruit juice
* Subject taking inducer or inhibitor of drug metabolism enzyme such as barbital within 28days prior to study medication dosing
* Continued serum potassium concentration abnormal status (on baseline visit, \< 3.5mEq/L or \> 5.5mEq/L)
* Subjects with decision of nonparticipation through investigator's review due to laboratory test results or other excuse such as non-responding to request or instruction by investigator
Conservation of Red Cell Mass , Oxygen Supply and Demand in Cardiac Surgery

Fifty patients will be enrolled into the study. The purpose of the study is to investigate the relevance of Hct levels in determining need for transfusion during operations employing bypass as well as to test the hypothesis that, while HCt levels may decrease during surgery , red blood cell mass and tissue oxygenation remain fairly constant.

Fifty adults( male or female-nonpregnant) whose weight is between 55-85 kg and are scheduled to undergo elective cardiac surgery with cardiopulmonary bypass for CABG or primary valve repair or replacement will be eligible. Patients with any history of abnormal bleeding disorders, urgent or emergent need for surgery, and combination surgeries will be excluded. Blood volume analysis will be performed with the DAXOR Blood Volume Analyzer BVA-100 System and the Volumex HSA I-131 radiopharmaceutical for use for determining circulating volume. Multiple timed sample points will be obtained. The DAXOR blood volume analyzer will batch samples and with input of patients height, weight, gender, time of draw, and corresponding Hct, calculate circulating total blood volume. We hypothesize that Total red cell mass is relatively well conserved( \<20% decrease) during and immediately after surgery as long as major bleeding does not occur. We hypothesize that decrease in Hct during surgery are related to changes in circulating plasma volume. Total red cell O2 carrying capacity and O2 economics will be measured and it is also hypothesized that lowered Hct values, even as low as 15%, do not independently signal a tissue or whole body O2 deficit.

Eligibility Criteria:
Inclusion Criteria:

* Patient scheduled to undergo elective Cabg or primary repair/replacement on bypass pump.
* Age 18 yrs or older
* Male or non pregnant female
* Weight between 55-85 kg.

Exclusion Criteria:

* Any known bleeding risks;
* Urgent or emergent surgery;
* Combined aortic and major vascular surgery;
* Pregnant women
* If participating in another study within last 90 days.
Development and Validation of the Prediction Model for Cognitive Impairment

According to the "Chinese Stroke Report" released in 2020, the incidence of stroke in China is 1114.8/100,000, acute ischemic stroke (AIS) accounts for 70% to 80% of the total number of stroke population, and elderly stroke patients are up to 2/3. About 1/3 of stroke patients would experience post-stroke cognitive impairment (PSCI), which seriously affected patients' quality of life and survival time, and increases disease and economic burden. Therefore, early identification, assessment, prevention and intervention of PSCI, and improvement of patients' quality of life and prognosis have become the focus of clinical research.

This is a prospective cohort study. We intend to: (1) continuously collect elderly AIS patients who will be admitted to the Department of Neurology, The Department of Rehabilitation and the Department of Gerontology of Shenzhen Second People's Hospital from 2022 year to 2024 year; (2) collect baseline and follow-up data, and build a prediction model for cognitive impairment in elderly AIS patients; (3) internal validation using Bootstrap model; (4) collect the data of the elderly AIS patients who will be admitted to Shenzhen Longhua District People's Hospital andShenzhen Longgang Central Hospital, and conduct external validation; (5) evaluate the predictive efficacy of the model.

This study consists of two parts. The first part is to develop a predictive model for cognitive impairment in elderly patients with acute ischemic stroke. Continuously collect the baseline data and follow-up data of elderly AIS patients admitted to the Shenzhen Second People's Hospital from September 2022 to December 2023, including general demographic data, laboratory examination indicators, imaging indicators and assessment scales. Take the occurrence of PSCI as the dependent variable and the risk factors of PSCI in elderly AIS patients will be analyzed. Multivariate Cox regression will be used to develop a prediction model for cognitive impairment in elderly AIS patients.

The second part is to do clinical evaluation of prediction model of cognitive impairment in elderly patients with acute ischemic stroke. Bootstrap method will be used for internal validation of the model. Continuously collect the data of elderly AIS patients from January 2024 to December 2024 from the other two hospitals in Guangdong Province, China. Externally validate the model and evaluate the clinical application effect of PSCI prediction model in elderly AIS patients using C-index, reclassification index, calibration curve, time-dependent ROC curve and other indicators. Finally, the model is presented by nomogram.

Eligibility Criteria:
Inclusion Criteria:

1. Patients age 60 years or older.
2. Stroke occurring within 7 days.
3. Meet the diagnostic criteria of Chinese Guidelines for the Diagnosis and Treatment of Acute ischemic Stroke 2018.
4. Informed consent.

Exclusion Criteria:

1. Incomplete main clinical data;
2. Patients with transient ischemic attack;
3. Patients had cognitive dysfunction before enrollment.
Pharmacokinetics of Dexmedetomidine in Morbid Obesity

Dexmedetomidine hydrochloride ,a relatively new drug in Chinais ,is a highly selective, potent a2-adrenoceptor agonist with significant analgesic, sedative and anxiolytic effects. The morbid obesity in Chinese population is rapidly increasing. But the pharmacokinetics of the drug in these people is still unknown.This research was designed to study the pharmacokinetics of dexmedetomidine in Chinese morbidly obese population.

For the obese are sensitive to the disease such as hypertension, ischaemic heart disease and diabetes, the changes of the state may affect the pharmacokinetics of dexmedetomidine. Besides,the clearance of dexmedetomidine is parallel with liver function and it is excreted by kidney, so differences in the obese may be expected.

About 10 obese patients and 10 matched healthy volunteers with normal weight would be chosen to receive a normal dosage of dexmedetomidine. And venous samples will be collected in different time points. Next the investigators can get the plasma concentration of dexmedetomidine by the use of HPLC-MS. And then the plasma concentration could be analyzed.

Eligibility Criteria:
Inclusion Criteria:

1. Weight:28≦BMI≦45 and 18.5≦BMI≦24
2. Written informed consent from the patient or the relatives of the participating patient.

Exclusion Criteria:

1. A previous history of intolerance to the study drug or related compounds and additives.
2. Existing significant haematological, endocrine, metabolic or gastrointestinal disease.
Effect of Biofeedback and Functional Electrical Stimulation in Children

40 children with hemiplegia cerebral palsy from both sex will be recruited from outpatient clinic of abo resh hospital ,their age ranged from 5-10 years

40 children with hemiplegia cerebral palsy from both sex will be recruited ,their age ranged from 5-10 years, treatment includes functional electrical nerve stimulation and biofeedback to assess their combined effect on upper limb function

Eligibility Criteria:
Inclusion Criteria:

* Their age will range from 5 to 10 years.
* Spasticity grade range from 1+ to 2, according to Modified Ashworth Scale (MAS) (Bohannon and Smith, 2011).
* Their UL ability function will be at level II according to Manual Ability Classification System (MACS) (Penta et al., 2001).
* They will be able to follow instructions.

Exclusion Criteria:

* Loss of sensation
* The presence of visual or auditory impairments.
* Musculoskeletal problems or fixed deformities in the upper extremities.
* Seizures.
* Surgical interference in upper limbs.
* Botulinum toxin injections in the last 6 months.
Real-Time Cholangioscopy Artificial Intelligence Evaluation of Biliary Strictures

The purpose of this study is to demonstrate the feasibility and validity of a previously developed peroral cholangioscopy (POC) convolutional neural network (CNN) to determine the etiology of biliary strictures when used in real-time.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old
* Anticipation that patient may undergo POC during an endoscopic retrograde cholangioscopy
* Pregnant patients can be included in the study. Use of the POC-CNN does not convey any new risk to the patient nor fetus.
* Non-English speaking subjects will be included in the study. Consent for the procedure itself is always done with the assistance of an interpreter via telephone or video. Use of the POC-CNN will be discussed with all patients via this interpreter during the procedure consent.

Exclusion Criteria:

* Age \<18 years old
* No indication that cholangioscopy will be performed during endoscopic retrograde cholangiopancreatography (ERCP)
* Prisoner
Treatment for Knee Osteoarthritis With Injections of BMC at the Bone-cartilage Interface. Pilot Study

This pilot study will evaluate the clinica! and radiological results of a treatment for knee osteoarthritis with injections of autologous concentrated bone marrow aspirate at the bone-cartilage interface via percutaneous.

This pilot study (N=30) patients will evaluate the clinica! and radiological results of a treatment for knee osteoarthritis with injections of bone marrow concentrate (BMC),obtained from the Bone Marrow Aspirate Concentration System (BioCUE) at the bone-cartilage interface via percutaneous injections. The PerFuse system will also be evaluated to determine if it can be used to deliver the BMC to the osseous sites. Follow-up is 1, 3, 6, 12, and 24 months.

Eligibility Criteria:
Inclusion Criteria:

* age ranging from 40 to 75
* Osteoarthritis of the medial or lateral compartment (2-3-4 grade according to the Kellgren-Lawrence score);
* Failure after at least 6 months of conservative treatment (drug therapy with NSAIDs,hyaluronic acid,platelet-rich plasma and corticosteroids injections);
* Signature of informed consent.

Exclusion Criteria:

* Patients with trauma in the 6 months prior to the intervention;
* Patients with malignancies;
* Patients with rheumatic diseases;
* Patients with diabetes;
* Patients suffering from metabolic disorders of the thyroid;
* Patients being abuse of alcohol, drugs or medications;
* Body Mass Index\> 35;
The Effectiveness and Safety for Mesenchymal Stem Cell for Alcoholic Liver Cirrhosis

Background \& Aim: Bone marrow derived mesenchymal stem cells (BM-MSCs) have capacity to differentiate into hepatocytes and anti-fibrotic effect in the experimental model. No study was done in humans with alcoholic liver cirrhosis. The researchers investigated the anti-fibrotic effect of BM-MSCs in alcoholic cirrhosis as Phase II clinical study.

Methods: Eleven alcoholic cirrhosis patients (M:F = 10:1) with Child-Pugh's class B and maintenance of alcohol abstinence at least 2 months were enrolled. At baseline, all patients received liver biopsy, hepatic venous pressure gradient (HVPG) measurement and serologic tests. BM-MSCs were isolated from each patient's BM and amplified for one month and injected two times at 4, 8week through Rt. hepatic artery. 5x106cells/mL of BM-MSCs were injected in each session. Follow up biopsy, HVPG and relative expression of tissue transforming growth factor-1 (TGF-β1), α smooth muscle actin (α-SMA) and collagen-1 by real time RT PCR were measured after 12weeks from 2nd BM-MSC injection. The primary outcome was improvement in patients' histology Aim :

The researchers aimed to evaluate safety and effectiveness of new therapy with bone marrow derived autologous mesenchymal stem cell for hepatic failure caused by alcoholic liver cirrhosis.

Autologous BM-MSCs therapy in alcoholic cirrhosis induces improvement of hepatic fibrosis in histological and quantitative measurements.

Eligibility Criteria:
Inclusion Criteria:

1. Alcoholic liver cirrhosis(child Pugh class B or C, ≥ 7 scores),confirmed by clinically or biopsy.
2. Stop drinking over past 6months.
3. Patients agree with informed consent Patients must satisfy all inclusion criteria.

Exclusion Criteria:

1. Patients who did not satisfy inclusion criteria
2. Hepatocellular carcinoma
3. Pregnancy or breast feeding
4. Infective disease(HIV, HBV, HCV..)
5. Other incurable malignancy
The Effects of Exercise Training on the Health-related Fitness of Colon Cancer Survivors

Recent studies have suggested that individuals diagnosed with colon cancer who are inactive and/or overweight, may have poorer survival outcomes. Exercise training has been shown to improve fitness and body composition in other cancer survivor groups. The investigators hypothesize that an exercise training program will be a safe, feasible, and effective intervention to improve the fitness and body composition of a group of colon cancer survivors.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed Stage II or III colon cancer diagnosis
* Less than or equal to 1 year since the completion of all adjuvant treatment
* Negative Physical Activity Readiness Questionnaire (PAR-Q) or completed Physical Activity Readiness Medical Examination (PARmed-X) form
* 18 years of age or older
* Ability to understand and provide written informed consent in English
* Willingness to be randomized
* Willingness to complete outcome measures at each assessment time point
* Available for the duration of study intervention period
* Able to travel to our fitness centre 3/week for the study period

Exclusion Criteria:

* Any absolute contraindication to to exercise testing or training
* Evidence of active disease (metastatic, recurrent, or unresectable colon cancer)
* Any uncontrolled medical condition or psychiatric illness that would prevent completion of the exercise program or interfere with the study assessments
Clinical Outcomes and Global Epidemiology -Data Coordinating Center

The primary objective is to assess for independent predictors of in-hospital mortality (up to 28 days) in patients with Acinetobacter bloodstream infection. Secondary Objectives include the following: To determine the impact of inactive empiric antimicrobial therapy, defined as receipt of empiric antimicrobial therapy with no in vitro activity against the offending isolate for at least 24hrs, on the outcome (end points defined below) of patients with Acinetobacter bloodstream infection. To determine the impact of carbapenem resistance and pan-drug resistance (defined as resistance to all antimicrobials except colistin and/or tigecycline if these agents were tested) on the outcome of patients with Acinetobacter bloodstream infection. To assess the efficacy of varying definitive therapies on the outcome of patients with Acinetobacter bloodstream infection. To characterize the molecular epidemiology of Acinetobacter on a global level, as determined by pulsed-field gel electrophoresis (PFGE) and other techniques, and to assess whether patient outcomes are clonally related and to characterize the mechanisms of resistance in Acinetobacter on a global scale.

Medical records will be reviewed and information collected from charts to assess for independent predictors of in-hospital mortality (up to 28 days) in patients with Acinetobacter bloodstream infection. 24 sites will participate and all information will be loaded into a password protected database.

Eligibility Criteria:
Inclusion Criteria:

* Acinetobacter bloodstream infection

Exclusion Criteria:

* Does not meet entry criteria
Pharmacokinetics of BI 409306 After a High Fat, High Caloric Meal and After a Single Oral Dose Given at Bed Time in Healthy Volunteers

To evaluate the effect of food on the pharmacokinetics of BI 409306 and to investigate the pharmacokinetics of BI 409306 when given at bed time.


Eligibility Criteria:
Inclusion criteria:

1. Healthy male and female volunteers
2. Age 18 (incl.) to 50 (incl.) years
3. Body mass index (BMI) range: 18.5 (incl.) to 29.9 (incl.) kg/m2

Exclusion criteria:

1. Any evidence of a clinically relevant concomitant disease
2. Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
3. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
4. Surgery of the gastrointestinal tract (except appendectomy)
5. Diseases of the central nervous system (including but not limited to any kind of seizures, stroke or psychiatric disorders)
6. History or evidence of relevant orthostatic reaction, fainting spells or blackouts, occurrence of syncopes, brady- or tachycardia in the anamnesis.
7. Positive pregnancy test
8. No adequate contraception during the study and until 1 month of study completion, i.e. intrauterine device (IUD), sexual abstinence (for at least 1 month prior to enrolment), or surgical sterilisation (incl. hysterectomy). Females, who are not surgically sterile will be asked to additionally use barrier contraception methods (e.g. condom, diaphragm with spermicide)
Injectable Extended-Release Buprenorphine (XR-B) in a Correctional Setting: Qualitative Interviews

This qualitative study investigates the potential benefits and challenges of using a once-a-month injectable medication, known as extended-release buprenorphine (XR-B), to treat individuals with opioid use disorder (OUD) within a correctional setting. The research aims to understand if XR-B can be a feasible and effective alternative to the standard daily treatment and to identify which groups within the prison population may benefit the most from this treatment. In-depth interviews are conducted with incarcerated individuals and relevant stakeholders.


Eligibility Criteria:
Incarcerated individuals, inclusion criteria:

* English speaking
* Over the age of 18
* Diagnosed with opioid use disorder

Incarcerated individuals, Exclusion Criteria:

- Diagnosed with "Severe, Persistent, Mental Illness (SPMI)" Rationale for Exclusion: These individuals suffer from severe mental health disease and therefore warrant greater protection, have greater risk for coercion, and offer insights to severe co-diagnosis treatment that, while important, remain outside the scope of general MAT implementation.

Organizational Stakeholders, Inclusion Criteria:

- Employed or contracted by Rhode Island Department of Corrections (for organizational staff interviews) and involved with the Medication for Addiction Treatment (MAT) program

Organizational Stakeholders, Exclusion Criteria:

- If not permitted by their organizational union to participate