cyrilzakka/clinical-trials huggingface dataset:
Influence of Telmisartan and Lacidipine, Combined or Alone, on QT Interval in Healthy Volunteers

Assessment of the influence of telmisartan, lacidipine and their combination on the QTC interval of the ECG


Eligibility Criteria:
Inclusion Criteria:

All participants in the study should be healthy males/females, range from 21 to 50 years of age and their body mass index (BMI) be within 18.5 to 29.9 kg/m2.

In accordance with Good Clinical Practice and local legislation all volunteers will have given their written informed consent prior to admission to the study.

Exclusion Criteria:

* Any finding of the medical examination (including blood pressure, heart rate and ECG) deviating from normal and of clinical relevance
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
* History of orthostatic hypotension, fainting spells or blackouts
* Chronic or relevant acute infections
* History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
* Intake of drugs with a long half-life (\>24 hours) within at least one month or less than ten half-lives of the respective drug before enrolment in the study or during the study
* Use of any drugs which might influence the results of the trial up to 7 days prior to enrolment in the study or during the study
* Participation in another tiral with an investigational drug (\<= two months prior to administration or during the trial)
* Smoker (\> 10 cigarettes or \> 3 cigars or \> 3 pipes/day)
* Inability to refrain from smoking on trial days
* Alcohol abuse (\> 60 g/day)
* Drug abuse
* Blood donation (\>= 100 ml within four weeks prior to administration or during the trial)
* Any laboratory value outside the clinically accepted reference range
* Excessive physical activities within the last week before the trial or during the trial

Following exclusion criteria are of special interest for this study:

* Hypersensitivity to telmisartan, lacidipine and/or related drugs of these classes
* Supine blood pressure at screening of systolic \<= 110 mmHg and diastolic \<= 60 mmHg
* Any ECG value outside of the reference range of clinical relevance, but not limited to PR interval \> 240 ms, QRS interval \> 110 ms, QTcB \> 470 ms for females and QTcB \> 450 ms for males

For female subjects:

* Pregnancy
* Positive pregnancy test
* No adequate contraception (adequate contraception e.g. sterilisation, intrauterine pessary (IUP), oral contraceptives)
* Inability to maintain this adequate contraception during the whole study period
* Lactation period
Reduction in Cardiovascular Risk Factors and Visceral Adipose Tissue in Men: Separate Effects of Diet- and Exercise-Induced Weight Loss

The purpose of the trial was to examine the independent effects of equivalent diet- or exercise-induced weight loss on obesity and related cardiovascular health risk factors. We hypothesized that exercise would result in greater reductions in obesity and health risk factors that equivalent diet (caloric restriction).


Eligibility Criteria:
Inclusion Criteria:

* Men between 20 and 60 yrs

Exclusion Criteria:

* Smokers and diabetics
Two Cases of Pulmonary Cysticercosis Manifesting as Pleural Effusion: Case Report and Literature Review

Isolation lung cysticercosis reports are rare in literature. Most lung lesions were characterized by nodules. The investigators access one case which was characterized with pulmonary cavity and pleural effusion by Gupta N, et al in 2015 from PUBMED and Medline. But pleural effusion and exudative lesions is reported for the first time.

Cysticercosis is an important public health problem in developing countries. The major involvement sites are the central nervous system and the eyes，although striated muscles and subcutaneous tissues are frequently involved in the disseminated form of disease. Pulmonary involvement in cysticercosis is very rare and ill-defined nodular shadows distributed throughout the lung is the usual radiological presentation. Only one case of cysticercosis presenting as lung cavity with pleural effusion has been reported so far in literature. The investigators describe two cases in which pleural effusion due to cysticercosis were detected on X and CT.

Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of Pulmonary Cysticercosis。
2. With pleural effusion

Exclusion Criteria:

1.No cysticercosis was found by biopsy or antibody test
Pilot Study "AHSP as a Biomarker of Sickle Cell Disease in a Population of Adults and Children"

Evaluation of AHSP concentration in total blood as a biomarker in adult and pediatric sickle cell patients

Research involving non-interventional humans. Selection and inclusion of patients by CHSD investigators. Collection of clinical data by investigators and CHSD URC staff.

Biochemical and hematological measurements by the CHSD medical biology laboratory for "care" samples Pseudonymization of 4 mL "research" samples by the URC then fractionation of the samples by 1 mL, and storage at -80°C within the medical biology laboratory of the CHSD.

Transport of samples at -80°C to team 1 of Dr Baudin-Creuza (Créteil). Preparation of genomic DNA from a 1 mL fraction then α and β globin genotyping by Dr Pissard.

Measurement of the AHSP concentration from the other fractions. Comparison of the AHSP concentration according to the group of subjects, and with the different parameters, then correlation analysis

Eligibility Criteria:
Inclusion Criteria:

Inclusion Criteria for Sickle Cell Patients

1. Adults: \> 15 years and 6 months
2. Pediatrics: ≥ 3 years and ≤ 15 years and 6 months
3. Known SS or Sβ0 phenotypes

Inclusion Criteria for Control Patients.

1 -Adults: \> 15 years and 6 months /Pediatrics: ≥ 3 years and ≤ 15 years and 6 months 2-Absence of Hemoglobinopathy 3-Follow-up for one of the following conditions (adults): Evaluation of hematological disease excluding hemoglobinopathy, evaluation of prolonged fever or inflammatory syndrome, initial or episodic evaluation of an auto-inflammatory disease or systemic disease, general health deterioration

-Follow-up for one of the following conditions (pediatrics): Suspected precocious puberty, growth delay, or neurodevelopmental disorder

4-Blood sample planned as part of medical care

Exclusion Criteria:

1. Hemoglobin disorder other than sickle cell disease (Criteria for Sickle Cell Patients)
2. Hemoglobinopathies other than sickle cell disease (Criteria for Control Patients)
3. Transfusion less than 3 months ago
4. Chronic active viral disease: hepatitis B, C, HIV
5. Current infections or known inflammatory pathologies
6. Known hyper or hypothyroidism or subject treated with levothyroxine
7. Active tumor pathology or remission for less than 5 years
8. Oral corticosteroid therapy in progress
9. Participation in interventional biomedical research
10. Opposition to participation in research by the patient if he is an adult, or by one of the two parents if the patient is a minor.
11. Non-affiliation to a social security system
Online Tai Chi Plus Fitbit After ACS

This projects studies the role of tai chi exercise and wearable fitness trackers to promote physical activity in acute coronary syndrome (ACS) survivors.

This is a two-site randomized controlled trial taking place at Beth Israel Deaconess Medical Center in Boston, MA and The Miriam Hospital in Providence, RI. Seventy (n=70) physically inactive ACS survivors will be randomized to either a 6-month group tai chi program (remotely-delivered classes on Zoom) integrated with a wearable self-monitoring/feedback device plus enhanced usual care (EUC), or to EUC alone. EUC will include usual care provided by participants' providers integrated with printed CHD risk factor education materials. Assessments will be conducted in-person at baseline, 6 months (end of treatment), and 9 months. Our primary outcomes will be focused on study feasibility and acceptability. Secondary outcomes include the following patient-centered outcomes: objectively measured (via accelerometry) moderate-vigorous physical activity, light physical activity, sedentary time, cognitive-behavioral constructs (exercise self-efficacy, intrinsic motivation, depression, stress, HRQL), and cardiometabolic measures (exercise capacity, body weight, lipid profile, blood pressure, fasting plasma glucose).

Eligibility Criteria:
Inclusion Criteria:

1. History of ACS (unstable angina, NSTEMI, and STEMI, defined per current AHA/ACC criteria);
2. Age ≥ 18;
3. Being physically inactive (i.e., \< 150 min/week of moderate-intensity aerobic PA);
4. Absence of contraindications to physical exercise per the participant's provider evaluation;
5. Access to a digital device with internet connection;
6. Having an active email account and ability to check email at least weekly;
7. Physician clearance to participate in low-moderate intensity exercise (tai chi), including a statement that there is no contraindication to exercise based on post-ACS stress test and other factors, as appropriate;
8. English speaking

Exclusion Criteria:

1. Inability or unwillingness to give informed consent;
2. Blood pressure \>200/110 or orthostatic systolic blood pressure decrease \>20 mmHg at the baseline visit;
3. Uncontrolled/untreated atrial or ventricular arrhythmias or 3rd degree AV block;
4. Within 3 months of a diagnosis of pericarditis or myocarditis;
5. Medical conditions likely to limit lifespan to less than one year;
6. New York Heart Association (NYHA) functional class IV;
7. Severe cognitive impairment (BOMC \>10);139
8. Orthopedic problems prohibiting TC practice;
9. Ongoing TC or other mind-body training (i.e., meditation, TC, or yoga) at least weekly;
10. Current enrollment in cardiac rehabilitation;
11. Untreated severe depression (PHQ\>=20);
12. Conditions likely to affect study compliance (i.e., moving out of study area, substance use, ongoing untreated psychosis);
13. Symptoms of unstable cardiovascular disease (e.g., shortness of breath or chest pain at rest and/or Canadian Cardiovascular Society Angina Class III-IV)
Pharyngeal Exercise (Plus Protein)

The swallowing muscles are prone to decreased strength and function as part of the natural aging process which can lead to difficulty swallowing, malnutrition, and frailty. Exercise and nutrition are powerful stimulators of muscular change. The proposed research will investigate the effectiveness of a 12-week proactive regimen of swallowing exercises (with or without daily protein supplement drinks) to improve the composition, force, and physiology of the swallowing muscles and explore the relationship to overall health and physical function in 80 community-dwelling older adults. Each participant will serve as their own control for 12 weeks before being randomized to complete swallowing exercises alone or swallowing exercises with protein drinks.


Eligibility Criteria:
Inclusion Criteria:

1. Participants must be 65 years of age or older.
2. Participants must score a 1 or 2 on the FRAIL scale OR a 4 or greater on the Strength, Assistance in Walking, Rise from a Chair, Climb Stairs and Falls (SARC-F) Questionnaire.
3. Participants must score 26 or greater on the Montreal Cognitive Assessment (MoCA).
4. Willingness to participate in the study procedures.

Exclusion Criteria:

1. Known structural or neurological causes of dysphagia.
2. Cannot consume high levels of protein (Chronic Kidney Disease Stage 3 or higher).
3. Contraindications to 3T whole body MRI scanners (e.g., pacemaker, cerebral aneurysm clip, cochlear implant, presence of shrapnel in strategic locations, metal in the eye, claustrophobia, or other problems).
Xengenic Cortical Membranes Versus Connective Tissue Graft With Coronally Advanced Flap for the Treatment of Peri-implant Soft Tissue Dehiscences: A Randomized, Controlled Clinical Trial

Peri-implant soft tissue dehiscences represent a common complication in implant dentistry, often leading to esthetic and functional challenges. Current treatment options, including Xengenic cortical membranes and connective tissue graft with coronally advanced flap, aim to promote soft tissue regeneration and improve clinical outcomes. However, there is a need for comparative studies to determine the optimal treatment modality for peri-implant soft tissue dehiscences.

Aim: Comparing the effectiveness and patient outcomes of Xengenic cortical membranes versus connective tissue graft with coronally advanced flap for the treatment of peri-implant soft tissue dehiscences.

Eligibility Criteria:
Inclusion Criteria:

* Adults (20-50) years old. •peri-implant soft tissue dehiscence . •Thin gingival phenotype. •Optimal compliance as evidenced by no missing treatment appointments and positive attitude towards oral hygiene.

Exclusion Criteria:

* •Medically compromised patients and systemic conditions precluding implant and periodontal surgery. •Smokers, diabetics, pregnant or lactating women. •History of chemotherapy, radiotherapy in head and/or neck region. •Bisphosphonate therapy.
Preoxygenation Using THRIVE Versus Facemask in Parturients

This study aims to determine the duration for pre-oxygenation using THRIVE and facemask for parturients.

We aim to determine the duration required for THRIVE and facemask preoxygenation in parturients for them to achieve ETO2 \>90%.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant patients ≥36 weeks gestation.
* Non-laboring patients admitted for elective Cesarean delivery under neuraxial anesthesia or induction of labor.
* American Society of Anesthesiologists (ASA) class 2.

Exclusion Criteria:

* Any medical conditions that are likely to affect gas exchange.
* Obstructed nasal passage.
* Unable to tolerate a tight fitting facemask.
* Body Mass Index ≥40 kg/m2.
* Patients who are in active labor (i.e. cervical dilation ≥4cm).
* Patients who are unable to give informed consent.
A Study to Test How Healthy Women Tolerate Different Doses of BI 1819479

The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 1819479 in healthy female subjects of non-childbearing potential.


Eligibility Criteria:
Inclusion Criteria:

* Healthy female subjects of non-childbearing potential according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
* Age between 18 years and 67 (inclusive)
* Body mass index (BMI) of 18.5 to 30.9 (weight divided by height squared)(kg/m2) (inclusive)
* Signed and dated written informed consent in accordance with International Conference on Harmonisation (ICH) - Good Clinical Practice (GCP) and local legislation prior to admission to the trial
* Female subject of non-childbearing potential defined as:

  * Permanently surgically sterilised (hysterectomy, bilateral salpingectomy and/or bilateral oophorectomy)
  * Postmenopausal, defined as no menses for 1 year in women aged = 51 years or no menses for 2 years in women aged = 50 years, without an alternative medical cause
  * In questionable cases of postmenopausal status:

    * Women not using sex hormone medication such as hormone replacement therapy may be included if a blood sample confirms levels of Follicle-stimulating hormone (FSH) \> 40 unit/liter (U/L) and estradiol \< 30 nanogram per liter (ng/L)
    * Women using sex hormone medication such as hormone replacement therapy cannot be included in the trial

Exclusion Criteria:

* Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
* Repeated measurement of systolic blood pressure outside the range of 90 to 140 millimetres of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 beats per minute (bpm)
* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
* Any evidence of a concomitant disease assessed as clinically relevant by the investigator
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
* Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
* History of relevant orthostatic hypotension, fainting spells, or blackouts
* Further exclusion criteria apply
Study of Octohydroaminoacridine Succinate Tablets in Patients With Alzheimer's Disease

The main purpose of this study is to evaluate the safety and efficacy of Octohydroaminoacridine Succinate tablets and find the optimal dose in patients with mild to moderate Alzheimer's Disease.

The purpose of this study is a preliminary assessment of the Octohydroaminoacridine Succinate tablets in the treatment of mild to moderate Alzheimer's disease and explore the efficacy and safety of the best dose. The 288 patients were randomly assigned to four groups: high dose (4mg / time), moderate dose (2mg / time), low dose (1mg / time) and the placebo group, including four weeks of the trial screening period following 16 weeks double-blind treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of probable AD based on DSM-IV and the NINCDS-ADRDA criteria.
2. Male/female patient aged between 50 and 85.
3. mild to moderate probable AD ：Middle school or above: 11 ≤MMSE ≤ 25, elementary school: 8 ≤ MMSE ≤ 20, illiteracy: 5 ≤ MMSE ≤ 16.
4. CT or MRI scan excluding another structural brain disease in one year.
5. Neurologic examination no significant abnormalities.
6. Hachinski Ischemic Score \< 4；Hamilton Depression Scale ≤10. Able to complete the test procedure, audio-visual and physical ability to act to complete the neuropsychological measure.
7. Stable chaperone, more than 2 hours a day together with the patient or accumulated fewer than 14 hours per week.
8. Informed consent of the patient (or legal representative) and of the caregiver agreeing to take part in the study.

Exclusion Criteria:

1. Proven or clinically suspected other type of dementia such as vascular dementia, Lewy body dementia, Parkinson's disease, frontotemporal dementia, g - Jakob disease (spastic pseudo-sclerosis), normal pressure hydrocephalus etc.
2. Sudden onset of early dementia or with gait disorders, seizures and behavioral changes.
3. Clinical manifestations of focal neurological signs (hemiparesis, sensory loss, visual field defect) or early extrapyramidal tract signs.
4. History of cerebrovascular disease and stroke.
5. Serious lack of folic acid and VitB12, syphilis antibody positive or thyroid dysfunction.
6. Mechanical intestinal obstruction patient ,Resting pulse less than 60,Severe liver or renal disease.
7. Patients with mechanical intestinal obstruction.
8. History of bone marrow transplantation.Mental illness, such as severe depression.
9. Cognitive damage caused by alcohol or drug abuse. Disable to correctly evaluate the cognitive function.
10. Critical condition, disable to make the exact evaluation of the efficacy and safety of new drug.
11. Use of any agent for the treatment of dementia within 4 weeks of randomization.
12. Be sensitive to ACHEI.
13. Be sensitive to two or more foods/drugs.
14. Use of another investigational agent within one months of screening.
Effect of Serving Size and Addition of Sugar on the Glycemic Response Elicited by Oatmeal

The purpose of this study was to determine the impact of serving size and the addition of sugar on the glycemic response elicited by oatmeal compared to that elicited by cream of rice cereal.


Eligibility Criteria:
Inclusion Criteria:

* body mass index (BMI) 20.0 - 34.9 kg/m²

Exclusion Criteria:

* known to have diabetes
* use of medications considered by the principal investigator to influence glycemic responses
Autologous Stem Cell Transplantation for Patients With AL Amyloidosis

This study mainly evaluated the efficacy and safety of autologous stem cell transplantation for the treatment of AL amyloidosis, the role of induction and maintenance therapy in autologous stem cell transplantation, and the long-term efficacy and prognosis risk factors of autologous stem cell transplantation for the treatment of AL amyloidosis.

This study is divided into two parts. In the first part, the investigators retrospectively analyze the data of patients with AL amyloidosis who treated with autologous stem cell transplantation from July 2010 to December 2019. All patients had a biopsy-proven disease by positive Congo red stain with a concomitant demonstration of plasma cell dyscrasia. Organ involvement was established according to the criteria established at the 10th International Symposium on Amyloid and Amyloidosis. The protocol of ASCT included mobilization with colony-stimulating factor alone and conditioning with high-dose melphalan 140 or 200 mg/m2. In addition to analyzing the efficacy and safety of all the patients, the investigators also analyzed the difference in efficacy between patients in different subgroups. For example, subgroups divided according to different induction treatment regimens; subgroups divided according to different plasma cell FISH data and FCM data; subgroups divided according to the degree of organ involvement, and subgroups divided according to different maintenance treatment regimens.

In the second part of the study, the investigators will conduct a prospective study to explore the best autologous stem cell transplantation treatment protocol for AL amyloidosis. The protocol includes the induction therapy with bortezomib and daratumumab before ASCT, the maintenance treatment with lenalidomide after ASCT, and the treatment options for recurrence after transplantation.

Eligibility Criteria:
Inclusion Criteria:

* Male or female;
* aged 18-75 years;
* Patients with newly diagnosed AL;
* Appropriate for autologous hematopoietic stem cell transplantation;
* Abnormal M protein or free light chain detected in serum and/or urine
* ECOG score 0-2 points;
* Subjects (or their legal representatives) must sign an informed consent document indicating understanding the purpose of and procedures required for the study and willingness to participate in the study.

Exclusion Criteria:

* Pregnant and breastfeeding women;
* Subjects suffering from multiple myeloma;
* hypersensitivity to any treatment drugs;
* Subjects have severe cardiovascular disease;
* Subjects have a serious physical disease and mental illnesses;
* Other conditions that researchers consider are not suitable for transplantation.