cyrilzakka/clinical-trials huggingface dataset:
Effects of Moderate Intensity Intermittent and Moderate Intensity Continuous Training on Hyperlipdemia

This project will be a Randomized control trial conducted to check the effects of moderate intensity intermittent training versus moderate intensity continuous training on indices of cardio-metabolic health in women with hyperlipidemia, duration will be of 5 weeks, purposive sampling data technique, will be done, subject following eligibility criteria from milestone gym Sialkot, will randomly allocated in two groups via lottery method, baseline assessment will be done, Group A participants will receive baseline treatment along with moderate intensity intermittent training, and Group B participants will receive baseline treatment along with moderate intensity continuous training. Pre and post intervention assessment will include lipid profile test and Vo2 max rating of perceived exertion (RPE), and post data will be analyzed by using SPSS version 25.

Hyperlipidemia is a condition with high levels of fat in the blood, such as cholesterol and triglycerides. Hyperlipidemia is most commonly associated with high-fat diets, sedentary lifestyle, obesity and diabetes. The aim of the current study is to find the effectiveness of moderate intensity intermittent training and moderate intensity continuous training in women with hyperlipidemia. It will be a Randomized control trial and screening will be done as per the inclusion criteria of women having 30-40 years of age with hyperlipidemia. Participants with the history of any serious cardiac condition, musculoskeletal injury, and any type of systemic issue will be excluded.

Participants will be randomly allocated into two groups, Group A will receive moderate intensity intermittent training consist of running for 5 km with 1-min at 70% of maximal aerobic speed with interval of 1-min passive recovery and Group B will receive moderate intensity continuous training consist of running continuously for 5 km at 70% of maximal aerobic speed for 5 weeks including exercise training of 3 days/week. Participants in both groups will be assessed with Lipid profile (fasting triglycerides, High Density Lipoproteins, Low density Lipoproteins) before and after the intervention.

VO2 max, rating of perceived exertion (RPE) Step Test: The step test is designed to measure a person's aerobic fitness. Participants step up and down, on and off an aerobic- type step for three minutes to increase heart rate and evaluate the heart's recovery rate during the minute immediately following the step test exercise.

Modified Borg scale: MBS is a 0-10 rated numerical score used to measure dyspnea as reported by the patient during submaximal exercise and is routinely administrated during six-minute walk testing.

Eligibility Criteria:
Inclusion Criteria:

* Women.
* Age 30-40 years.
* Hyperlipidemia

Exclusion Criteria:

* With another serious cardiac condition.
* With any musculoskeletal injury.
* With any systematic condition.
Incidence of Post-operative Pain After Single-visit Versus Two-visit Treatment

Aim :to compare incidence of post-operative pain and apical healing after single-visit versus two-visit root canal treatment of teeth with necrotic pulp and apical periodontitis.

Aim to compare incidence of post-operative pain and apical healing after single-visit versus two-visit root canal treatment of teeth with necrotic pulp and apical periodontitis.

Methodology: All teeth of the one and two-visit group were asymptomatic (92) and symptomatic (18) with a diagnosis of pulp necrosis (RCT cases) determined by hot and cold sensitivity tests and radiographically all teeth showed a small and irregular radiolucency at the tooth apex. Working length was established with EAL and confirmed radiographically. Reciprocating files (VDW, Munich Germany) were used to complete root canal preparation. EDTA served as a lubricant.

Eligibility Criteria:
Inclusion Criteria:

1. The aims and requirements of the study were freely accepted;
2. Treatment was limited to patients in good health;
3. All teeth had nonvital pulps and apical periodontitis, with or without a sinus tract;
4. A negative response to hot and cold pulp sensitivity tests;
5. Presence of sufficient coronal tooth structure for rubber dam isolation;
6. No prior endodontic treatment on the involved tooth
7. No analgesics or antibiotics were used five days before the clinical procedures began.

Exclusion Criteria:

1. Patients who did not meet inclusion requirements;
2. Patients who did not provide authorization for participation;
3. Patients who were younger than 16 years old;
4. Patients who were pregnant;
5. Patients who were diabetic;
6. Patients with a positive history of antibiotic use within the past month;
7. Patients whose tooth had been previously accessed or endodontically treated;
8. Teeth with root resorption,
9. Immature/open apex, or a root canal in which patency of the apical foramen could not be established were all excluded from the study. Teeth with periodontal pockets deeper than 4 mm also were excluded of the study.
Clinical Study of Endovascular Interventional Surgical Instrument Control System and Related Consumables in Percutaneous Coronary Intervention

The goal of this study is to evaluate the safety and effectiveness of endovascular interventional surgery instrument control system （ALLVAS®robot）and supporting consumables for coronary artery interventional surgery.

Participants will will complete coronary intervention surgery with the assistance of robot system（ALLVAS®robot）, and evaluate the effect of the use effect of robots and clinical treatment after surgery

Interventional therapy plays an important role in the treatment of coronary heart disease. At present, the main treatment methods still rely on human hands, and there are some defects, including but not limited to hand shaking and visual error. The use of robots may partly circumvent the above shortcomings.

This study is to evaluate the safety and effectiveness of ALLVAS®robot for coronary artery interventional surgery.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who voluntarily participate in and sign the informed consent form, and can cooperate to complete the whole trial process;
2. aged over 18 and under 75;
3. After coronary CT angiography (CTA) or coronary angiography (DSA), the investigator judged that the patients who needed interventional blood supply reconstruction (target vessel diameter ≥ 2.5mm and lesion stenosis ≥ 70%).

Exclusion Criteria:

1. Acute myocardial infarction occurred within 7 days;
2. The target vessel has received coronary intervention within 30 days;
3. Restenosis in stent of target vessel;
4. Patients with bifurcation lesions whose target vessel branches need to be protected but cannot protect the collateral branches;
5. Hemodynamic instability (including low blood pressure or use of vasopressors to maintain blood pressure;)
6. Three vessel lesions;
7. The target vessel was diagnosed as coronary chronic occlusive disease (CTO) or left main artery stenosis or severe calcification requiring pretreatment;
8. Perforation, dissection or aneurysm of the proximal vessel of the target vessel;
9. Echocardiography showed that left ventricular ejection fraction (LVEF) was less than 50%;
10. Stroke or transient ischemic attack (TIA) occurred within 30 days;
11. Peptic ulcer or gastrointestinal bleeding within 90 days;
12. Estimated glomerular filtration rate eGFR (ckd epi)\<30 ml/min/1.73 m2;
13. Platelet count\<50 × 109/L or \> 700 × 109/L； White blood cell count \< 3 × 109/L;
14. Women who are in pregnancy or lactation or have a pregnancy preparation plan during the trial period;
15. People with allergy history or contraindication to antiplatelet drugs, anticoagulants, anesthetics, contrast agents, stent materials and their coating drugs;
16. Severe infections difficult to control;
17. Those who have mental diseases or mental disorders and cannot be described normally;
18. Emergency operation is required for any reason;
19. Those who have participated in clinical trials of other drugs or medical devices within 3 months before screening;
20. The investigator believes that there are other circumstances that are not suitable for this clinical trial.
Risk Factors Contributing to the Development of Microalbuminuria

This research project will look at the relationship between baseline variables, and the new onset of microalbuminuria and the response to treatment with an angiotensin receptor blocker, losartan, in a cohort of 246 early hypertensives and normotensives who are being brought back for a 4-5 year follow up visit as part of a continuing project. We hypothesize that the new onset of microalbuminuria is associated with higher blood pressure levels at baseline and 1 year as well as being associated with elevated left ventricular mass index. The rate of new onset microalbuminuria in non-diabetics is not established and this prospective study will provide data.

The primary objective of this research project is to determine risk factors related to the development of microalbuminuria. The secondary objective is to determine whether uric acid levels at the final visit are correlated with the onset of microalbuminuria. Of participants returning for a 4-5 year follow up visit as part of a continuing project, we will examine the proportion that have developed microalbuminuria. Subjects found to have microalbuminuria will be offered therapy with the ARB losartan and will be followed at three months to determine if there has been a reduction in levels.

Eligibility Criteria:
Inclusion Criteria:

* participation in the Double Exposure study
* elevated microalbuminuria
DIU-QoL. Quality of Life Evaluation in Intrauterine Device Users.

Knowledge about the impact on quality of life of women initiating IUD in the Spanish population at baseline and after 12 months of use.


Eligibility Criteria:
Inclusion Criteria:

* 18-49 years old female.
* Women who is visited by a gynecology or primary care physician and starts contraception with an IUD/IUS.
* Women that has not used hormonal contraception in any form in the last 3 months.
* Women who have no problems listening, reading or writing.
* Women who gives their written consent to participate in the study.

Exclusion Criteria:

* Women who have contraindications to use IUDs.
* Women with previous experience with IUDs.
* Women who initiates the use of IUDs for other purposes other than contraception.
* Woman who is participating in a clinical trial at the time of initiating the study.
KetaMoHydBup: Pharmacokinetic Interaction of S-ketamine, Morphine, Hydromorphone and Buprenorphine

S-ketamine is often administered as a part of multimodal analgesia to reduce postoperative pain and postoperative opioid consumption. Current data indicates that ketamine may be useful for patients with prior use of opioids whereas the benefit for opioid-naive patients is less clear. However, different opioids have variable pharmacokinetic characteristics. Therefore, it is important to evaluate S-ketamine's effect on the pharmacokinetics of opioids.

S-ketamine is often used as a part of multimodal analgesia to reduce postoperative pain and opioid consumption, in part by mitigating opioid tolerance and opioid-induced hyperalgesia. However, there are mixed results concerning the effect of ketamine for this indication. Different opioids have various pharmacokinetic characteristics. Ketamine is known to inhibit the liver UGT2B7-enzyme, that is responsible for e.g., morphine metabolism. Therefore, it is important to investigate whether there is a clinically important pharmacokinetic interaction between S-ketamine and opioids metabolized via liver UGT2B7 enzyme. These opioids include morphpine, hydromorphone and buprenoprhine.

Eligibility Criteria:
Inclusion Criteria:

* written informed consent
* age 18-45 years
* healthy
* Normal values in the following laboratory assessments: Hb, P-ALAT, P-AFOS, P-GT, P-creatinine, P-K, P-Na, chemical sample for urine (U-KemSeul). Pregnancy test (P-hCG-tot) must be negative.
* Urine sample for detection of any illegal drugs must be negative (U-Huum-PS)
* Normal EKG
* Normal blood pressure
* No prior use of illicit drugs

Exclusion Criteria:

* Tendency/predisposition to illicit drug use, illicit drug use in history
* Abnormal EKG
* smoking
* use of oral contraceptives
* pregnancy, lactation
* participating in a less tha 3 months ago
* Blood donation less than 3 months ago
* The subject's peripheral veins are hardly visible (predisposing difficulties in cannulation)
* weight less than 50 kg, body mass index (BMI) less than 18,5 or over 30
Oocyte Recipient's Decision in the Number of Embryos to be Transferred

Multiple pregnancies are considered an ART complication. The only effective way to reduce its incidence is to transfer a single embryo. Nonetheless, there is some reluctance among the patients to accept this strategy. In IVF/ICSI programs, it has been demonstrated that, after receiving the information about the similar cumulative live birth rate after single embryo transfer (SET) and double embryo transfer (DET) and the obstetric and perinatal risks of multiple pregnancy, a significant number of patients opt for SET. Up to date, no comparable studies have been published in oocyte recipients. The aim of this study is to evaluate if the information given to the patients influence their preference on the number of embryos to be transferred. It also seeks to identify factors which determine the initial preference and factors which can explain a hypothetic change in this preference.


Eligibility Criteria:
Inclusion Criteria:

* Patients under their first oocyte or embryo donation cycle.
* Sufficient knowledge of Spanish to fill out questionnaires.

Exclusion Criteria:

* Patients with a medical indication for single embryo transfer (e.g. Turner syndrome, uterine surgeries, cardiovascular risk).
* Having had previous oocyte or embryo donation cycles.
* Insufficient knowledge of Spanish.
Clinical Performance of Fiber Reinforced FRC Base and Bonded CAD/CAM Resin Composite Endocrowns Versus Conventional Lithium Disilicate Endocrowns in Posterior Teeth (1y Randomized Clinical Trial).

In patients with endodontically treated molar teeth indicated for endocrown, will the fiber reinforced FRC base and bonded CAD/CAM resin composite endocrowns restorations have a similar clinical performance to the conventional lithium disilicate endocrown over one year?


Eligibility Criteria:
Inclusion Criteria:

* Patients with good oral hygiene
* Patients having one or more endodontically treated molars that need prosthetic restoration.
* Molars should have enough tooth structure for endocrown restoration with minimum 3 walls with thickness not less than 1.5 mm and gingival step placed supragingival
* Fully erupted molars
* Molars free of developmental defect
* Healthy periodontium
* Absence of periapical pathosis
* Acceptable endodontic treatment and proper bone support

Exclusion Criteria:

* Patients with bad oral hygiene
* Patients with active periodontal disease
* Patients with missing teeth opposing to the area intended for restoration
* Patients with parafunctional habits or psychiatric problems or unrealistic expectation.
An Observational Follow-up Study for Subjects Receiving Salvage Therapy After Previous Treatment in a Visilizumab Study for Intravenous Steroid-Refractory Ulcerative Colitis

To assess the effects of visilizumab on the safety of subsequent salvage therapies in subjects who experienced disease progression in a previous visilizumab study and subsequently received salvage therapy.


Eligibility Criteria:
Inclusion Criteria:

* Previous participation in a visilizumab study of IVSR-UC.
* Disease progression while enrolled in a previous visilizumab study, and subsequent treatment with salvage therapy.

Exclusion Criteria:

* Unable to understand the purpose and risks of the study, or unwilling or unable to provide a signed and dated informed consent.
* For U.S. sites, unwilling or unable to provide authorization to use protected health information.
Study To Assess the Dietary Carbohydrate Content of Indian Diabetic Population

The study is designed as an interventional (as blood investigations will be done) dietary survey of diabetic \& non-diabetic population sample of India to understand \& compare dietary patterns among them.The study objective is to find out amount of carbohydrate content of daily diet of diabetic population study . This study does not intend to study the effect of any drugs. There will be 2 groups : Type 2 diabetics and non diabetic population. The study will begin after the study approval by ethics committee. The subject will involved after they sign the consent form. The study involves general examination of patients, collection of data like history of disease, interview by dietitian with the help of questionnaire, blood investigations (only in diabetic population only) and glycaemic control status of only diabetic population.The study is planned to be enroll 800 subjects (400 in each groups) from 10 study centers spread across India. The study data will be analyzed with appropriate statistical methods.


Eligibility Criteria:
Inclusion Criteria:

* Diabetic Population
* Patients willing to provide signed \& dated informed consent and comply with study
* Indian diabetic population diagnosed with T2DM for at least 12 months
* Male and non pregnant female with age18 years or more

  * Non-Diabetic Population
* Indian non-diabetic population who are not following any diet plan or dietary advice
* Patients willing to provide signed \& dated informed consent and comply with study requirements.
* Male and non pregnant female with age 18 years or more
* Non-diabetic population should be matched in terms of age, sex and centre

Exclusion Criteria:

* Patient unwilling to comply with the study procedures.
* Pregnant \& lactating women
* History of cardiovascular event within the previous six months.
* Patients with specific co morbidities, which may impact the patients diet, e.g malignant diseases, advanced dementia, Parkinson's disease and others.
* Suffering from chronic diseases including but not limited to chronic renal failure, chronic liver disease that might interfere with participation in the study as per physician discretion.
* Patients on weight management plan e.g. low carbohydrate diet which includes dietary modifications or dietary alterations.
The Impact of Frailty on Thrombosis of Elderly Patients With NVAF （FTE-NVAF）

This study aims to investigate the use of anticoagulants in elderly patients with non-valvular atrial fibrillation (NVAF) and the incidence of frailty in elderly patients with NVAF. After two years follow-up, we observe the incidence of thrombotic events and the influence of frailty on thrombotic events in elderly patients with NVAF.


Eligibility Criteria:
Inclusion Criteria:

* ≥65yr
* Confirmed non-valvular atrial fibrillation (NVAF) diagnosis with ECG or Holter
* fulfilled CHA2DS2-VASc, HAS-BLED and Fried Scale
* patients agreed and provided informed consent

Exclusion Criteria:

* valvular atrial fibrillation
* cardiac surgery related atrial fibrillation
* acute disease related atrial fibrillation
* patients not fulfilled all the exam and text，or not accept the follow-up
CellFX System for the Treatment of Cutaneous Non-Genital Warts

This prospective, non-randomized, multicenter pivotal study is designed to evaluate the safety and effectiveness of the CellFX System in patients with cutaneous non-genital warts on all areas of the body, excluding the face.

The study will enroll healthy adult subjects with a minimum of two cutaneous non-genital warts, excluding the face, with each wart lesion not exceeding 10 x 10mm. One of the warts for each subject will be untreated and will serve as the subject's internal control. Macrophotography of all study warts will be captured along with Investigator assessments using the Wart Measurement Scale (WMS) and lesion measurements for wart reduction. All subjects will be followed at 7, 30, 60, 90 and 120-days post-initial CellFX treatment. All wart lesions are eligible for re-treatment up to 3 times over the course of the study. Adverse events will be documented.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must be at least 21 and not older than 80 years of age
* Subjects must be able to read and speak English or Spanish
* Subjects must sign a written informed consent to participate in the study, prior to any study related procedures
* Subject must have a minimum of two cutaneous non-genital warts, each not exceeding 10 x 10mm
* Subject is willing to undergo all study-mandated procedures
* Subject agrees to refrain from using all other wart removal products or treatments (topical medication including over-the-counter medications) during the study period

Exclusion Criteria:

* Subject has an implantable electronic medical device. (pacemaker, implantable cardioverter defibrillator, etc.)
* Subject has cochlear implants
* Subject has an active systemic infection or history of an infection in the designated treatment area within 90 days of enrollment
* Subject has a history of and/or current tinnitus
* Subject is known to be immune-compromised
* Subject is taking a blood thinning medication (Antiplatelet, Anticoagulation, Factor Xa Inhibitor, etc.)
* Subject has Type 1 Diabetes and is insulin dependent
* Subject has a known allergy to Lidocaine or Lidocaine-like products
* Subject is a member of a vulnerable population including individuals employed by the Sponsor, clinic site, or entity associated with the conduct of the study
* Subject has a comorbidity or condition which may reduce compliance with this protocol, including follow-up visits
* Subject is participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device)
Testing the Efficacy of REThink Main Game-based ER Strategies on the Stress Reactivity

This activity will aim to test the comparative efficacy of the main game-based emotion-regulation abilities training of the REThink online game: cognitive change, biofeedback and problem-solving in reducing stress reactivity of the children and adolescents

Children included in this study (aged 8-16 years, G\*Power estimated N=98) will be allocated to one of the three experimental conditions (cognitive change, biofeedback and problem-solving game based training based on the REThink online game levels), or no intervention Control condition. All children will be exposed afterwards to psychosocial stress in the form of peer rejection "ball toss" task. It will be measure both game-based skills outcomes, and EMA stress reactivity outcomes.

Eligibility Criteria:
Inclusion Criteria:

children and adolescents between 8 and 16 years provided written parental consent

Exclusion Criteria:

Intellectual disability or physical limitations precluded the use of the computer program
Levosimendan Administration and Outcome in Cardiac Surgery

To assess the effects on outcome of levosimendan with respect to timing of its administration on the postoperative course of high-risk cardiac surgery patients in a retrospective observational study.


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing cardiac surgery between 2006 and 2013
* levosimendan administration within 24 hours of postoperative ICU admission

Exclusion Criteria:

* patients younger than 18