cyrilzakka/clinical-trials huggingface dataset:
Effect of Roselle-based Drink on Blood Pressure and Skin

This randomized, placebo-controlled, double-blind, and cross-over study was designed to check whether the roselle-based drink (2 bottles every day) can alter blood pressure and skin condition in elderly healthy subjects.

The subjects were assigned into two groups (control group and test group), each group subject was requested to drink 2 bottles every day (100 mL/bottle, one in the morning and another in the evening), the rate of drinking is 75.42%. There are 39 subjects (25 females and 14 males) completely involved in the thirteen-month trial (cross-over). Blood samples were collected at the initial, 3rd, 6th, 7th, 10th, 13th months of the trial. Skin examinations were performed at the initial, 6th, 7th, 13th months.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults
* Subjects should not be under any medication
* Subject must be able to drink

Exclusion Criteria:

* Subjects with chronic renal, liver or cardiac disorders, Diabetes, hyperlipidemia.
* Also pregnant women, chain smokers, high alcohol consumers should not be included.
Hospital vs. Cell Phone Number Follow-Up Randomization Study

This study is being conducted to evaluate the hypothesis that study subjects will be more responsive to follow-up phone calls made from personal cell phone numbers than from hospital landline numbers. To evaluate this, study subjects previously enrolled in a cardiac biomarker study (the Early Identification of Acute Coronary Syndrome study) were randomized to receive their follow-up phone calls (the calls associated with the Early ID study occur at 30 days and 1 year after initial enrollment) from either a hospital office landline or from the personal cell phones of the research assistants making these calls. This was done as a 1:1 randomization. The number of call attempts required to reach the study subjects were recorded as the calls were made and the date of successful follow-up was recorded once contact was made.


Eligibility Criteria:
Inclusion Criteria:

* Enrollment in the Early Identification of Acute Coronary Syndrome study
* Working telephone numbers

Exclusion Criteria:

* None
2940nm Er:YAG Laser Versus Benzoyl Peroxide Gel for the Treatment of Inflammatory Acne

Acne is one of the most common conditions that patients seek for help in dermatological clinic. Nowadays, conventional treatment including topical agents(retinoids, antibiotics ,antiseptics and keratolytic agents) and systemic agents( antibiotics and retinoids) give a satisfying result but not to every patient. Some patients are not well respond to conventional therapy while some patients are unable to tolerate side effects of the treatments. Therefore, interventions to reduce acne are vigorously experimented . Lights and lasers including intense pulsed light, pulsed dye laser with or without photosensitizer and infrared lasers have been found to be useful in treating active inflammatory acne. Although,pain ,downtime and poor response of comedonal acne are limitations of those lights and lasers therapy. 2940 nm Erbium:YAG laser which has both resurfacing and photothermal effects is our laser of interest to seek for its efficacy in the treatment of inflammatory acne.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 year-old to 45 year-old
* Mild to moderate severity of acne vulgaris with at least 5 active inflammatory acne lesions on each side of the face and less than 25% difference in lesion count between each side of face
* Fitzpatrick skin phototype I-IV

Exclusion Criteria:

* History or clinical presentation of hypertrophic scar or keloid
* Photoaggravated skin diseases i.e. systemic lupus erythematosus, polymorphous light eruption, solar urticaria
* Oral isotretinoin taken within the last 6 months prior to enrollment
* Topical retinoid within 4 weeks prior to enrollment
* Systemic acne therapies (oral antibiotics) within 4 week prior to enrollment
Sano V First In Human Study to Treat ED

A Prospective, First in Human Study to Evaluate the Safety and Performance of a Flow Modification System


Eligibility Criteria:
Inclusion Criteria:

1. Patient understands and has signed the study informed consent form.
2. Documented history of erectile dysfunction
3. Sexually active

Exclusion Criteria:

- 1. Current participation in any clinical study with any investigational drug or device.

2. Patient is known or suspected not to tolerate the procedure, including exposure to contrast 3. Active infection or fever that may be due to infection 4. Life expectancy \< 2 years due to other illnesses
Seek, Test, Treat Strategies for Vietnamese Drug Users: A Randomized Controlled Trial

This research examines the effectiveness of an intervention that employs seek, test, and treat strategies for Vietnamese injection drug users (IDU) and their network members, by ensuring that high risk individuals are sought for HIV testing and promptly referred to and maintained on antiretroviral therapy (ART). HIV prevention interventions are provided to IDUs who test HIV-negative, as well as those who test HIV-positive. HIV-positive IDUs will be referred to HIV care through a two-arm randomized controlled trial to compare the effects of different levels of engagement in care on ART uptake, ART adherence, and treatment outcome.

Opioid injection and HIV infection are major public health problems in Vietnam. Injection drug users (IDUs) have a high burden of HIV infection (20% HIV prevalence, nationally; 6% mortality per year) and the high rate of HIV transmission continues (HIV incidence, 5% per year). The investigators propose an intervention that employs the seek, test, and treat strategies for the IDU population and their network members, by ensuring that high risk individuals are sought for HIV testing, promptly referred to and maintained on ART, while HIV prevention interventions provided to the many who test HIV-negative, as well as those who test HIV-positive. The intervention will seek and test IDUs and their network members in the community, particularly those who are recently released from drug treatment centers. HIV-positive IDUs will be referred to HIV care through a two arm randomized controlled trial to compare the effects of different levels of engagement in care on ART uptake, antiretroviral adherence, and treatment outcome.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years or older;
2. Recently released from drug treatment centers;
3. Positive HIV serology;
4. Male;
5. Meet criteria for ART initiation according to Vietnam's national guidelines;
6. Provide informed consent for the study; and
7. Reside in study area and do not plan to move away in the next 18 months.

Exclusion Criteria:

1. Currently on ART;
2. Co-enrollment in other HIV interventional research study;
3. Unwilling to provide locator information.
Interventional Study Targeting Oral Infections in Patients With Chronic Kidney Disease

This study aims to investigate the prevalence of oral infection in chronic renal disease patients and to examine whether a focused oral hygiene intervention can reduce oral infection leading to reduced systemic inflammatory parameters in chronic renal disease patients in hemodialysis, chronic renal disease patients waiting for kidney transplantation, and chronic renal disease patients who has been transplanted 1-1½ year previously. The results will be compared to a gender- and age-matched healthy control group.

Aim:

The aim is to examine if a focused oral care procedure to reduce oral infection will be mirrored in reduction of systemic inflammatory parameters in chronic renal disease patients.

Specific research questions:

Can oral infection and systemic inflammatory parameters in chronic renal disease patients be reduced by 1 month of professional oral care and individual prophylactic instruction and can a potential reduction of inflammation be continuously achieved at a 3 months follow-up.

Study design:

Randomized, double-blinded (investigator, outcomes assessor), controlled study. For Eligibility Criteria and Outcome Measures, please see elsewhere in the ClinicalTrials.gov Protocol Registration System.

Participants:

A: Hemodialysis patients, inclusion n=34, B: Hemodialysis patients on a kidney transplant waiting list, inclusion n=34, C: Patients who have had a kidney transplant (1-1½ years after transplantation), inclusion n=34. D: Gender- and age-matched healthy control group.

Number of included patients is estimated from a hypothesis-generating pilot study, a statistical power analysis and the estimated loss to follow-up based on experience from previous research projects in the Nephrology Department.

Intervention and control:

The intervention consists of professional oral care (addressing periodontal and oral mucosal infections, salivary gland dysfunction and caries prevention) and a didactic approach to individual instruction in oral hygiene/prophylactic measures performed by a dental hygienist at three visits: baseline, 2 weeks after baseline and 1 month after baseline.

The research data will be registered by a blinded investigator before the first visit at the dental hygienist and after 3 months.

The control group will follow best-clinical-practice procedures currently implemented in the hospital.

Eligibility Criteria:
Inclusion Criteria:

* Patients on a kidney transplant waiting list or patients who have had a kidney transplant (1-1½ year previously)
* Dentate patients (\>10 teeth)
* Age \>18 years
* Danish language

Exclusion Criteria:

* Patients not capable of following the research protocol
* Legally unavailable
* Need of antibiotic prophylaxis with dental treatment
* Heart valve surgery
Targeting Trimethylamine N-Oxide for Cardiovascular Health In Liver Transplant Recipients

Despite medical and surgical advances, long-term survival in liver transplant (LT) recipients is compromised by an increased risk of cardiovascular disease (CVD) after transplant, the mechanisms of which are still not fully understood. TMAO is an attractive therapeutic target to improve vascular health and diastolic function toward preventing CVD in LT patients. Therefore, the purpose of this study is to better understand the role of TMAO in cardiovascular dysfunction patients with chronic kidney disease.

Despite medical and surgical advances, long-term survival in liver transplant (LT) recipients is compromised by an increased risk of cardiovascular disease (CVD) after transplant, the mechanisms of which are still not fully understood. Following LT, patients have an increased incidence of atherosclerotic CVD. Notably, atherosclerotic CVD is an established risk factor for diastolic dysfunction and incident heart failure with preserved ejection fraction (HFpEF). There is a critical need to better understand the biological mechanisms of LT related vascular dysfunction and establish targeted interventions that will reduce the risk of CVD in this patient population. In the general population, there is strong epidemiological evidence linking high TMAO levels with atherosclerotic CVD and heart failure, and that it can modulated rapidly by diet within two weeks. Therefore, the purpose of this study is to better understand the role of TMAO in cardiovascular dysfunction patients with chronic kidney disease.

Eligibility Criteria:
Inclusion Criteria:

* Aged \> 18 years
* Speak and understand English
* Have received and LT

Exclusion Criteria:

* Acute cellular or chronic rejection within 3 months
* Post-LT liver or non-liver related malignancy
* Active viral hepatitis (B or C) or autoimmune hepatitis
* Untreated biliary strictures or vascular complications (e.g. hepatic artery thrombosis)
* Poorly controlled diabetes (HbA1c \>8.5%)
* Relapse of alcohol use after LT
* Follow a vegetarian or vegan diet
* Current pregnancy
* Unable to provide informed consent
Bio-HPP vs Cast Co-cr as Implant Framework

The purpose of this study was to assess the effect of Bio-Hpp versus Co-Cr custom abutments in fixed-detachable implant-supported mandibular partial dentures clinically and radiographically in Class I Kennedy classification (split-mouth study)

Participants with bilateral partial edentulism in the posterior mandible received two implants at the positions of the second premolar and second molar on both sides; one side was restored with BioHpp based screw-retained FDP (test group) and the other side was restored with Co-Cr based screw-retained FDP (control group). All patients were clinically examined at the time of prosthesis insertion, and 6,12 months later for fracture of implant or framework, fracture, or looseness of the screw, veneer chipping, and fractures, modified bleeding index, modified plaque index, peri-implant probing depth, as well as radiographically for marginal bone loss

Eligibility Criteria:
Inclusion Criteria:

* Mandibular posterior edentulous with the first premolar as the last standing abutment tooth bilaterally.

  * All patients were edentulous for at least 6 months from the last extraction.
  * The bone height of the alveolar ridge was not less than 12 mm above the inferior alveolar canal and the buccolingual width of the alveolar ridge at the prospective implant site was not less than 6 mm.
  * The opposing arch was almost dentulous, and any missing teeth were restored using a fixed partial denture.
  * Adequate interarch space at least 5mm between the opposing dentition and the mandibular edentulous space.
  * Remaining teeth were in good periodontal condition.
  * Maintaining good oral hygiene and were ready to cooperate throughout the study.

Exclusion Criteria:

* Patients with active infection or inflammation or flabby tissue in the areas intended for implant placement.

  * Those patients with systemic diseases that may influence soft or hard tissue healing.
  * Patients with a history of radiation therapy in the head and neck region.
  * Neurological or psychiatric handicap patients that could interfere with good oral hygiene.
  * Heavy smokers and drug abusers.
  * Patients with severe clenching or bruxism.
Study of BGB-11417 Monotherapy in Participants With Relapsed or Refractory Mantle Cell Lymphoma

The study consists of two parts. Part 1 determines the safety and tolerability of BGB-11417 (sonrotoclax) monotherapy, the maximum tolerated dose, and the recommended Phase 2 dose of BGB-11417 monotherapy for relapsed or refractory mantle cell lymphoma. Part 2 evaluates efficacy of BGB-11417 monotherapy at the recommended Phase 2 dose with recommended ramp-up schedule from Part 1.


Eligibility Criteria:
Key Inclusion Criteria:

1. Histologically confirmed diagnosis of MCL
2. Prior systemic treatments for MCL (at least one line of anti-cluster of differentiation 20 (anti-CD20) based immune or chemoimmunotherapy and at least one kind of covalent or non-covalent adequate Bruton Tyrosine Kinase (BTK) inhibitor).
3. Relapsed/refractory disease
4. Presence of measurable disease
5. Availability of archival tissue confirming diagnosis of MCL, or willing to undergo fresh tumor biopsy
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2.
7. Adequate organ function

Key Exclusion Criteria:

1. Known central nervous system involvement by lymphoma
2. Prior malignancy other than MCL within the past 3 years, except for curatively treated basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, or localized Gleason score 6 prostate cancer.
3. Prior exposure to a BCL-2 inhibitor (eg, venetoclax/ABT-199).
4. Prior autologous stem cell transplant within the last 3 months; or prior autologous chimeric antigen receptor T-cell therapy within the last 3 months; or prior allogeneic stem cell transplant within the last 6 months or currently has an active graft-vs-host disease requiring the use of immunosuppressants.
5. Clinically significant cardiovascular disease.
6. Major surgery or significant injury ≤ 4 weeks prior to start of study treatment.
7. Active fungal, bacterial or viral infection requiring systemic treatment.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Effect of GLP-1 Receptor (GLP-1R) Agonists on Cardiac Function and on Epicardial Adipose Tissue (EAT) Volume and on Myocardial TG Content in Obese Diabetics

Glucagon-like peptide-1 (GLP-1) receptor agonist are new treatment of type 2 diabetes, they lower blood glucose level (by enhancement of glucose-dependent insulin secretion and suppression of excess glucagon secretion) and reduce weight by inducing satiety and slowing of gastric emptying. Beneficial effects of GLP-1 and GLP-1 receptor (GLP-1R) agonists on cardiovascular function have been suggested. They improve biomarkers of CV risk, decrease systolic blood pressure, improve endothelial function and have beneficial effects on myocardium. Nevertheless, few studies have analysed the effect of GLP1 treatment on myocardial function in type 2 obese diabetic.

Myocardial steatosis is an independent predictor of diastolic dysfunction in type 2 diabetes mellitus. It was recently shown that 16 weeks of caloric restriction in obese patients with diabetes decrease myocardial triglyceride content and improve myocardial function (cardiac output, normalized stroke volume, LV mass and normalized end diastolic volume), and diastolic function. However, no study has evaluated the impact of Glucagon-like peptide-1 (GLP-1) receptor agonist in obese diabetics on myocardial TG content.

Recent studies have suggested that increased epicardial adipose tissue (EAT) could be an important risk factor for cardiac diseases. We and others have already evidenced a correlation between the volume of epicardial adipose tissue and the presence or the severity of coronaropathy. The impact of weight loss on the volume of EAT or the characteristics of EAT is mostly unknown.


Eligibility Criteria:
Inclusion Criteria:

* - Patients with type 2 diabetes according to WHO criteria
* Age\> 18 years
* BMI ≥ 30 kg/m2
* HbA1c\> 7% and \<10%
* Processing by ADO (Metformin and Glimepiride)
* Effective contraception (for women)
* Signed informed consent by the patient before inclusion in the protocol

Exclusion Criteria:

* Ongoing pregnancy or become pregnant within six months of the study protocol
* Breastfeeding
* Recent weight loss (\> 5% of total weight)
* Treatments changing the distribution of adipose tissue as corticosteroids or glitazones
* Acute coronary syndrome or unstable angina during the last three months
* Contraindications to cardiac MRI (mechanical heart valve, pacemaker, metallic intraocular foreign body, claustrophobia)
* Contraindication to cold test: Raynaud's syndrome
* Contraindication to exenatide:

  * Neoplasia active or untreated or in remission for less than 5 years (except for basal cell carcinoma or in situ cervical or prostate)
  * Contraindication to ADO (depending on specific product) in combination with exenatide.
  * History of kidney transplant or dialysis or plasmatique creatinine\> 1.5 mg / dL for men and\> 1.2 mg / dL for women
  * Digestive diseases, including gastroparesis
  * plasma triglycerides\> 1000 mg / dL
  * History of pancreatitis confirmed biologically
  * contraindication or hypersensitivity to Exenatide or one of its social coverage composantsAbsence
SpinChip Hs-cTnI Sample Type Validation

During a heart attack, the protein troponin I is released from the heart muscle into the bloodstream. Measurements of cardiac troponin in blood are used as an aid in the diagnosis of heart attack. The SpinChip hs-cTnI test is a new high-sensitive test for measuring the amount of cardiac troponin I in the bloodstream as an aid in the diagnosis of heart attack.

The purpose of this study is to demonstrate that different types of blood samples (finger prick, venous whole blood and plasma) return comparable results when analysed using the SpinChip hs-cTnI test. Blood samples from at least 150 patients will be analyzed and the testing will be carried out by healthcare personnel.

Cardiac troponins are widely used as a biomarker to aid in the diagnosis of Acute myocardial infarction (AMI). These structural proteins are essential in regulating contraction in cardiac muscle cells, and they are sensitive and specific biochemical markers of myocardial damage.

During a heart attack, cardiac muscle cells are injured and release the cardiac marker troponin I (cTnI) into the bloodstream. High-sensitive troponin tests may detect the increase of cardiac troponin in blood within hours after the symptoms of a heart attack has started.

The SpinChip high-sensitivity cardiac troponin I (hs-cTnI) test is a new high-sensitive test for measuring troponin I in blood samples, and the analysis may be performed close to the patient (near-patient test). The results may be obtained within 10 minutes, compared to approximately 1 hour for normal laboratory analysis.

The SpinChip Platform consists of the SpinChip hs-cTnI test and the SpinChip Analyzer and may be used at the emergency department to evaluate patients presenting with symptoms of acute myocardial infarction (chest pain). The test can use blood from finger prick or venous blood samples, either as whole blood or separated into plasma.

The purpose of this study is to demonstrate that different sample types (finger prick, venous whole blood or plasma) give comparable results when analysed using the SpinChip hs-cTnI test when the testing is performed by healthcare professionals. Samples from minimum 150 patients with troponin levels covering the measuring range of the SpinChip hs-cTnI test will be collected and analysed.

Eligibility Criteria:
Inclusion Criteria:

* Able and willing to provide signed written informed consent
* Subjects \>18 years old
* Clinical cardiac Troponin T concentration available

Exclusion Criteria:

* Cognitive impairment precluding informed consent
* Self-reported pregnancy
* General clinical condition which affects the patient in a major way and the patient is considered to be in an unstable clinical condition
* Previously included in the study with a sample within the measuring range of the SpinChip hs-cTnI test