cyrilzakka/clinical-trials huggingface dataset:
Randomized Study of Obicetrapib as an Adjunct to Statin Therapy

This study will be a placebo-controlled, double-blind, randomized, phase 2 dose-finding study to evaluate the efficacy, safety, and tolerability of obicetrapib as an adjunct to high-intensity statin therapy.

This study will be a placebo-controlled, double-blind, randomized, phase 2 dose-finding study to evaluate the efficacy, safety, and tolerability of obicetrapib as an adjunct to high-intensity statin therapy. The screening period for this study will take up to 2-weeks. Afterwards patients will be randomized to placebo, 5 mg obicetrapib or 10 mg obicetrapib for an 8-week treatment period. After the treatment period, patients will continue for a 4-week safety follow-up and a 15-week PK follow-up.

Eligibility Criteria:
Inclusion Criteria:

* LDL-C \> 70 mg/dL and TG \< 400 mg/dL,
* Treated with a high-intensity statin therapy

Exclusion Criteria:

* BMI \> 40 kg/m
* Significant cardiovascular disease
* HbA1c \> 10%
* Uncontrolled hypertension
* Active muscle disease
* GFR \< 60 ml/min
* Hepatic dysfunction
* Anemia
* History of malignancy
* Alcohol abuse
* Treatment with investigational product
* Treatment with PCSK9
* Clinically significant condition
* Known CETP inhibitor allergy
Comparative Effectiveness and Safety Between Warfarin and Dabigatran

This is a comparative effectiveness and safety study of clinical events among patients taking either dabigatran or warfarin. There is no formal hypothesis to be tested, but rather to provide the estimates on the incidence of stroke and systemic embolism (effectiveness) and bleeding events (safety) using 95% confidence interval for comparison between those non0-valvular atrial fibrillation patients taking dabigatran vs. warfarin using a large, nation-wide claims data in Japan.

This is a comparative effectiveness and safety study of clinical events among patients taking either dabigatran or warfarin. There is no formal hypothesis to be tested, but rather to provide the estimates on the incidence of stroke and systemic embolism (effectiveness) and bleeding events (safety) using 95% confidence interval for comparison between those non-valvular atrial fibrillation patients taking dabigatran vs. warfarin using a large, nation-wide claims data in Japan.

Eligibility Criteria:
Inclusion Criteria:

* patients aged \>18 year-old with confirmed diagnosis of Non-Valvular Atrial Fibrillation (NVAF) (ICD 10 code I48)
* having a first prescription (index date) of either dabigatran or warfarin between 14 March 2011 to 30 June 2016
* having no prescription of any Oral Anticoagulants (OACs) for 12 months prior to the index date (this period is defined as the baseline period)

Exclusion Criteria:

* patients having less than 12 months of enrolment prior to the index date
* being dialysis or kidney transplant recipients in baseline period
* having either atrial flutter, valvular atrial fibrillation (AF)
* mechanical valve placement, rheumatic AF
* and/or mitral valve prolapse/regurge/stenosis in baseline period
* having record of deep vein thrombosis or pulmonary embolism \< 6 months before AF diagnosis in baseline period
A Substudy of the Effect of Acute Normovolemic Hemodilution in Bone Tumor Surgery

The prevention of perioperative anemia has the potential to reduce complications, hospital stays, and long-term prognosis in patients undergoing bone tumor surgery. Data from previous studies suggest that the clinical efficacy of acute normovolemic hemodilution (ANH) has always been controversial, and intraoperative fluid administration strategy is an important confounding factor. The HEAL trial will assess whether ANH will improve postoperative hemoglobin levels when applying goal-directed fluid therapy in patients undergoing bone tumor surgery.

Bone tumor surgery is associated with a significant risk of perioperative blood loss, with blood loss usually in the range of approximately 500-1000 ml. The postoperative anemia caused by blood loss is an independent risk factor for postoperative complications in patients undergoing bone tumor surgery, as well as affecting the long-term survival rate of cancer patients.

Acute normovolemic hemodilution (ANH) is a patient blood management measure. The clinical efficacy of acute normovolemic hemodilution (ANH) has always been controversial, and intraoperative fluid administration strategy is an important confounding factor. As goal-directed fluid therapy (GDFT) is increasingly used in clinical practice, it is of great importance to explore the efficacy of ANH in patients undergoing fluid management using GDFT.

Bone tumor surgery is an ideal setting to evaluate ANH in GDFT, as the procedure is associated with high blood loss and infusion. This trial has been designed as a randomized, controlled trial to determine whether ANH will improve postoperative hemoglobin levels when applying GDFT in patients undergoing bone tumor surgery.

Eligibility Criteria:
Inclusion Criteria:

1. age 18 to 75 years;
2. undergoing elective bone tumor resection surgery;
3. preoperative hemoglobin ≥11 g/dL;

Exclusion Criteria:

1. using a tourniquet;
2. palliative operation or minimally invasive surgery;
3. BMI\<18.5 or \>30Kg/m\^2;
4. international normalized ratio (INR) \>1.5 or platelet count \<100 × 10\^9/L;
5. cardiopulmonary insufficiency;
6. hepatic and renal dysfunction;
7. active infectious disease;
8. allergy to succinyl gelatin;
9. pregnancy;
10. declined participation in the study or declined blood transfusion
Neural Exercises vs Surgery in Patients With Carpal Tunnel Syndrome

neural exercise in patients with carpal tunnel syndrome

OBJECTIVE: The aim objective is to compare the neurophysiological effects of the surgery versus neural mobilization exercises added to surgery versus only neural mobilization exercises on temporal summation and noxious inhibitory pain system and their relationship with the improve of symptoms, with pain and disability in patients with Carpal tunnel syndrome.

STUDY DESIGN: Randomized parallel-group trial. BACKGROUND: Carpal tunnel syndrome (CTS) such as a neuropathic pain condition with altered pain modulation and wind-up, but there is a clack of knowledge if some therapies could have a positive effect.

METHODS: In the Humans study, 54 patients with CTS will be randomly allocated to either a surgery group (n=18) or Surgery with neural exercises group (n=18) or neural exercise group (n=18), the groups with neural exercise will received 10 sessions. The primary outcome will be conditioned pain modulation, temporal summation, pain intensity,. Secondary outcomes will be hand disability assessed with the Boston Carpal Tunnel Questionnaire, pinch-tip grip force, and the symptom severity subscale of the Boston Carpal Tunnel Questionnaire, neuropathic pain questionnaire (DN4), psychological questionnaires (anxiety, catastrophizing, kinesiophobia depression and fear avoid questionnaires), and pressure pain threshold. Patients will be assessed baseline and post-treatment, 1, 3 and 6 months after the last treatment by an assessor unaware of group assignment Patients were assessed at. Analysis was by intention to treat, with mixed analyses of covariance adjusted for baseline scores.

Eligibility Criteria:
Inclusion Criteria:

Tinel and Phalen positive 4/10 in VAS Scale Increase symptoms at night 12 months of symptomatology Sensorial and motor dysfunction in the conduction of the median nerve

Exclusion Criteria:

Previous surgery Wrist fractures Rheumatoid Arthritis or Fibromyalgia Systemic disease Pregnancy
Efficacy of Oropharyngeal Exercises for Patients With Obstructive Sleep Apnea Using Mandibular Advancement Device

Combined treatment with MAD and OE for adult patients with obstructive sleep apnea can significantly (i) improve muscle strength and endurance; (ii) reduce the severity of sleep apnea.

Background: Obstructive Sleep Apnea (OSA) is a sleeping disorder with recurrent upper airway obstruction during sleep. Patients with OSA often suffer from daytime sleepiness, snoring, and interrupted breathing during sleep. The etiology of OSA can divide into anatomical causes, including narrow, crowded, or easily collapsible upper airway, and non-anatomical causes, including low respiratory arousal threshold, ineffective or reduced pharyngeal dilator muscle activity during sleep, and unstable ventilatory control. A mandibular advancement device (MAD) is one of the treatment options for mild to moderate OSA patients. Oropharyngeal exercises (OE) are a novel intervention targeted at internal/external tongue muscle training with significant improvements in the muscle tension and severity of OSA. The efficacy of combined treatment with MAD and OE has not been investigated. Thus, the present study aims to determine the effectiveness of combing MAD and OE by assessing the tongue function and severity of OSA in patients with OSA.

Methods: A total of 20 participants using MAD for OSA were included in the study. Participants will be divided into two groups: the treatment group with the 12-week OE. OE consists of one to three times 30-minute sessions per day, 3 to 5 days per week for 12 weeks. The weekly clinic visits are required to adjust the intensity of the home exercise program and monitor the training progress. The participants in two groups will receive polysomnography (PSG) test, tongue muscle strength, and endurance testing, at baseline and after the intervention.

Expected results: Combined treatment with MAD and OE for adult patients with mild to moderate obstructive sleep apnea can significantly (i) improve muscle strength and endurance; (ii) reduce the severity of sleep apnea

Eligibility Criteria:
Inclusion Criteria:

* OSA patients
* aged over 20 years old
* wearing a MAD

Exclusion Criteria:

* Body Mass Index (BMI) ≧ 35
* Pregnancy
* Severe obstructive or restrictive lung disease
* Exercise with high-risk cardiovascular disease
* History of central or peripheral neurological disease resulting in an inability to perform exercise prescriptions
* Musculoskeletal or psychological disorders that prevent the performance of exercise prescriptions
* Chronic illnesses that are ongoing or not yet controlled
Vermont Diabetes Information System

The Vermont Diabetes Information System (VDIS) is a registry-based decision support and reminder system based on the Chronic Care Model and targeted to primary care physicians and their patients with diabetes. It will be evaluated by a randomized, controlled study in 60 Primary Care practices in Vermont and nearby New York.

The long-term goal of the Vermont Diabetes Information System is to reduce morbidity and mortality from diabetes mellitus. The project will implement and evaluate a state-wide system to support evidence-based disease management by primary care providers, their practices, and their patients in the community. The primary study question is: "What is the effect of a Diabetes Information System (including education, feedback and decision support) upon disease control measured by glycated hemoglobin?" Secondary questions address the effect of the system upon adherence to guideline recommendations, blood pressure control, patient satisfaction, medication use, and functional status. We hypothesize that the information system will result in improvements in the process and outcomes of clinical care. There are two specific aims:

Aim 1: Implement the Diabetes Information System. Objective 1.1: Develop a registry of patients with diabetes in primary care practices in Vermont; Objective 1.2: Provide education and feedback to providers regarding their patients with diabetes; Objective 1.3: Deliver decision support (flow sheets, alerts and reminders) based on the registry and targeted at primary care providers and patients, to prompt ideal management of diabetes.

Aim 2: Assess the Diabetes Information System. Objective 2.1: Assess disease control and guideline adherence by examining registry data in all subjects in a prospective, two-year, randomized, controlled trial in 60 primary care practices; Objective 2.2: Assess outcomes (blood pressure control, obesity, functional status, symptoms, medication use, and satisfaction) by interview and examination in a sub-sample of patients from the controlled trial.

Eligibility Criteria:
Inclusion Criteria:

* Adult
* Diabetes confirmed by Primary Care provider

Exclusion Criteria:

* Severe dementia
* Nursing home resident
Observational Study of the Heart Repair Technologies Mitral Bridge in Treating Mitral Valve Regurgitation

Prospective, observational, multi-center trial in which patients with mitral regurgitation sufficient to merit mitral valve repair will receive a surgical transvalvular, intra-annular Mitral Bridge™ to reduce or eliminate mitral regurgitation.

The primary objective of this study is to evaluate the safety and performance of the Mitral Bridge device in the correction of mitral valve regurgitation in patients who qualify for mitral valve repair as defined by the American Society of Echocardiography (ASE). The device is a single use, mitral valve implant designed to reduce mitral regurgitation by reducing the septo-lateral mitral annular diameter, promoting early coaptation of the valve leaflets and restraining the leaflets below the intra-annular plane.

The protocol was designed as a First In Man (FIM) with a 6-month follow up but was amended to follow the enrolled patients for a total of 5 years.

Eligibility Criteria:
Inclusion Criteria:

* Patients moderate to severe, symptomatic functional (ischemic or dilated cardiomyopathies) mitral regurgitation or mitral regurgitation caused by dilation of the mitral annulus who qualify for mitral valve repair with cardiopulmonary bypass
* Mitral regurgitation must meet the following criteria:
* The primary regurgitant jet is central, originating from mal coaptation of anterior and posterior leaflets of the mitral valve.
* If a secondary jet is present, the jet must be considered clinically insignificant.
* Women of child-bearing potential have a negative pregnancy test

Exclusion Criteria:

* Evidence of severe mitral annular and leaflet calcification.
* Patient is hemodynamically unstable.
* Patient has hypertrophic cardiomyopathy and has systolic anterior motion of the leaflets.
* Patient requires emergency surgery.
* Patient has echocardiographic evidence of endocarditis or rheumatic heart disease.
* Transesophageal Echocardiogram (TEE) is contraindicated or cannot be performed intraoperatively for any reason.
* Patient has known chronic, dialysis-dependent renal failure.
* History of stroke, transient ischemic attack (TIA) or reversible ischemic neurological disease within the last three (3) months.
* History of gastrointestinal bleeding within the last three (3) months.
* History of hypersensitivity or allergy to aspirin
* History or hypersensitivity to clopidogrel (Plavix) or its congeners.
* Active or treated malignancies in the last twelve (12) months.
* Patient is participating in another clinical study for which follow-up is currently ongoing.
* Women of child-bearing age who have not had a negative pregnancy test.
* Patient with non-cardiac co-morbidities and life expectancy \< 1 year.
* Patient has a condition that, in the opinion of the Investigator, precludes participation, including willingness to comply with all follow-up procedures.
Clinical Assessment of Two Reusable Silicone Hydrogel Contact Lenses

The purpose of this study is to compare the clinical performance of LID018869 soft contact with ACUVUE® OASYS with HYDRACLEAR® PLUS (AOHP) soft contact lenses over 30 days of daily wear.

Subjects will be expected to attend 6 visits. Subjects will be expected to wear their study contact lenses every day for at least 10 hours per day over a 30-day period for each study lens type. The total duration of a subject's participation in the study will be approximately 65 days.

Eligibility Criteria:
Key Inclusion Criteria:

* Current wearer of a commercial spherical weekly/monthly soft contact lenses with at least 3 months of wearing experience, with a minimum wearing time of 5 days per week and 10 hours per day.
* Manifest cylinder less than or equal to 0.75 diopter in each eye.
* Best corrected distance visual acuity better than or equal to 20/25 Snellen in each eye.
* Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

* Monovision or multifocal lens wearer.
* Habitual senofilcon contact lens wearer (for example, Acuvue Oasys, Acuvue Vita) or commercially available lehfilcon A contact lens wearer (TOTAL30).
* Routinely sleeps in habitual contact lenses.
* Other protocol-defined exclusion criteria may apply.
A Study in Healthy Subjects to Assess the Safety, Tolerability and Pharmacokinetics of HTL0022562

Phase 1, randomised, double-blind, first in human, two part, single centre, placebo controlled, single and multiple ascending dose trial in healthy adult subjects to evaluate the safety, tolerability and pharmacokinetics of HTL0022562.

This is a first in human, two part, double blind, placebo controlled, randomised single and multiple ascending subcutaneous dose study to evaluate the safety, tolerability and pharmacokinetics of HTL0022562.

Part 1 comprises of 7 sequential ascending dosing cohorts and Part 2 comprises of 4 multiple ascending dosing cohorts.

Eligibility Criteria:
Key Inclusion Criteria:

* Healthy males or healthy females of non-childbearing potential (WoNCBP) aged 18 to 55 years inclusive, with a body mass index \>18.5-\<30kgm2 and body weight ≥50kg.
* Healthy on the basis of a clinical history, physical examination, electrocardiogram (ECG), vital signs and laboratory tests of blood and urine.
* Willingness to comply with requirements or the trial, including contraception requirements.
* Able to give fully informed consent.

Key Exclusion Criteria:

* Confirmed current Coronavirus Disease 2019 (COVID 19) infection before randomisation.
* Clinical signs and symptoms consistent with COVID 19 (e.g. fever, dry cough, dyspnoea, sore throat, or fatigue) or confirmed infection by appropriate laboratory test within the last 4 weeks prior to Screening or on admission.
* Suffered from severe course of COVID 19 (extracorporeal membrane oxygenation (ECMO), mechanically ventilated).
* Receipt of any investigational medicinal product (IMP) in a clinical research study within the previous 3 months (or 5 half-lives, whichever is longer) of Screening.
* Any abnormalities on 12-lead ECG or BP at Screening (as specified).
* History of any drug or alcohol abuse in the past 2 years.
* Vital signs outside the normal range for healthy volunteers
* Clinically significant abnormal biochemistry, haematology, coagulation, or urinalysis
* Abnormal renal function, hepatic function or history of abnormal hepatic function occurring during treatment with investigational or licensed drugs, which led to permanent discontinuation of treatment.
* Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (anti HCV), or human immunodeficiency virus (HIV)
* History of clinically significant cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease, neurological or psychiatric disorder, or current hepatic renal dysfunction as judged by the investigator.
* Risk factor for ischaemic heart disease or cerebrovascular disease.
* Failure to satisfy, in the Investigator's judgement, the subject's fitness to participate for any other reason, including previous serious adverse reaction or serious hypersensitivity reactions to any drug or formulation excipients administered parenterally or orally.
* All female subjects must have a negative serum and urine pregnancy test at Screening and admission, respectively.
Clinical Effect of Reflexology and Homeopathy Added to Conventional Asthma Management

There is a lack of scientific evidence that homeopathy and reflexology is effective treatment of asthma. Systematic reviews have found that many clinical trials testing homeopathy and reflexology have major flaws, such as small number of participants, lack of control groups or inadequate allocation concealment.

The aim of the present study was to assess the effect of reflexology and individualised homeopathy as an adjuvant treatment in asthma. In order to address this issue, the investigators conducted an investigator-blinded, randomized, controlled parallel group study.


Eligibility Criteria:
Inclusion Criteria:

* Forced expiratory volume in 1 second (FEV1) ≥60% predicted
* A history of bronchial asthma for minimum 6 months prior to baseline
* An objective measure of abnormal variation in bronchial calibre(The objective measure were defined as at least one of the following)

  1. a positive bronchodilator reversibility test, defined as increase in FEV1≥10% after 400 µg inhaled salbutamol;
  2. a positive methacholine test, defined as a PD20 of \<1000 μg;
  3. a positive test for exercise induced asthma defined as a fall in FEV1\>15% after a standardised 6 min exercise test; and
  4. a positive peak expiratory flow (PEF) variability , defined by ≥3 days or 2 consecutive days with a differences between morning and evening PEF of \>20% during a 2-week period.

Exclusion Criteria:

* Hospitalization for asthma within 3 months,
* Asthma exacerbation during the last month,
* Changes in asthma medication within 30 days of screening
* A smoking history \> 10 pack-years and smoking within the last year.
Responsiveness and Validation Study of MFM-32 in SMA Patients Treated With Nusinersen

The Motor Function Measure (MFM), a reliable tool assessing motor function and its progression in most neuromuscular diseases, is widely used in France in many teams. It can be used regardless of the severity of the motor impairment or the ambulatory status of the patient, allowing its use throughout the whole follow-up period of the patient, even in case of the loss of walking. Two versions of the MFM exist, one composed of 32 items originally validated for patients from 6 years old (MFM-32) and a shorter version composed of 20 items originally validated for patients between 2 and 6 years old (MFM-20).

In order to prove the possible use of MFM-32 as early as the age of 2 years to validly and reliably monitor the evolution of the motor function of children treated with Nusinersen, we propose in this project to study the sensitivity to treatment-induced change of MFM-32 and the validity of the scale in this population.


Eligibility Criteria:
Inclusion Criteria:

* Boys and girls with Type 1 or 2 Spinal Muscular Atrophy, genetically confirmed
* Aged 2 to 6 years old
* Treated by Nusinersen for at least two months
* With parental assent

Exclusion Criteria:

* Patients with associated cognitive impairment making impossible evaluation of motor function
* Patients participating to a clinical study with a potential effect on their motor function.