cyrilzakka/clinical-trials huggingface dataset:
Choosing the Right Pacing Mode in Heart Failure - The CHOICE Trial

The aim of the study is to see if biventricular pacemakers offer any advantage over conventional pacemakers in patients with heart failure who require pacemakers. The endpoints will be the 6 minute walking distance along with markers of cardiovascular function.

The investigators' hypothesis is that biventricular pacing is preferable to conventional pacing in these heart failure patients.


Eligibility Criteria:
Inclusion Criteria:

1. Left ventricular systolic dysfunction.
2. Atrio-ventricular node disease.
3. Anticipated to be more than 40% paced, (including patients in permanent atrial fibrillation).
4. Ability to walk independently (walking aid permitted).

Exclusion Criteria:

1. Patients meeting criteria for CRT by current guidelines will be excluded.
2. Life expectancy less than12 months.
3. Inability to walk independently.
4. Patients not likely to be compliant with follow-up.
5. Bradyarrhythmia due with sino-atrial disease only.
A Brain Imaging Study of Tai Chi on Fibromyalgia

To accomplish our Specific Aims, we propose to conduct a two-session fMRI experiment in up to 30 patients with fibromyalgia (FM) and up to 30 healthy controls. All subjects will be invited to complete the second, identical fMRI session about 3 months following completion of the first session. Fibromyalgia subjects will complete their scans before and after a 12-week Tai Chi intervention in collaboration with Tufts Medical Center.


Eligibility Criteria:
Criteria for fibromyalgia patients.

Inclusion Criteria:

* Volunteers 18-50 years of age.
* Fibromyalgia for at least the past 3 months, as determined by the referring physician.
* At least a 10th grade English-reading level; English can be a second language provided that the patients feel they understand all the questions used in the assessment measures.

Exclusion Criteria:

* Specific causes of pain (e.g., cancer, fractures, spinal stenosis, infections)
* History of cardiac, respiratory, or nervous system disease that, in the investigator's judgment, precludes participation in the study because of a heightened potential for adverse outcome.
* Presence of any contraindications to fMRI scanning. For example: cardiac pacemaker, metal implants, fear of closed spaces, pregnancy.

Criteria for healthy adults.

Inclusion Criteria:

* Volunteers 18-50 years of age.
* At least a 10th grade English-reading level; English can be a second language provided that the patients feel they understand all the questions used in the assessment measures.

Exclusion Criteria:

* Chronic and acute pain (ex. Fibromyalgia).
* History of cardiac, respiratory, or nervous system disease that, in the investigator's judgment, precludes participation in the study because of a heightened potential for adverse outcome.
* Presence of any contraindications to fMRI scanning. For example: cardiac pacemaker, metal implants, fear of closed spaces, pregnancy.
A Specification Clinical Application Research of Tripterygium Wilfordii Treating Rheumatoid Arthritis

Rheumatoid Arthritis (RA) is an autoimmune disease that results in a chronic inflammatory disorder that may affect many synovial joints, and may cause serious disability. It has been confirmed that Tripterygium Wilfordii has effects of anti-inflammatory, immunosuppressive and cartilage protection. This is a multicenter ,double Blind, randomized study to evaluated the efficacy and safety of Tripterygium Wilfordii in treating of patients with rheumatoid arthritis (RA) and establish a prediction model for Tripterygium Wilfordii response of rheumatoid arthritis (RA).

Two arms were included in this study. Active Comparator: Patients were treated with Methotrexate (MTX)and Tripterygium wilfordii Hook F（TwHF）placebo.Experimental:Patients were treated with Methotrexate (MTX) placebo and Tripterygium wilfordii Hook F（TwHF)

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with rheumatoid arthritis as determined by the 1987 or 2010 ACR classification criteria;
* No male or female fertility requirements, or around menopause women;
* Patients with mild-to-moderate activity, 2.6 \< DAS28≤5.1;
* No serious system involved, such as severe pericardial effusion, interstitial lung disease, renal tubular acidosis, atrophic gastritis, autoimmune liver disease, etc;
* Within a month before the selected participants did not attend any drugs

Exclusion Criteria:

* Patients with cancer or other malignant disease such as cardiovascular, hematopoietic, liver and kidney disease, and psychopath
* Active or chronic infection, including HIV, hepatitis C virus, hepatitis B virus, tuberculosis
* Previous treated with tripterygii, glucocorticoid or biologic disease-modifying antirheumatic drug (DMARD) in 3 months.
* Previous treated with Tripterygium Wilfordii or MTX
* Patients with retinopathy.
ImpACT for Developmental Coordination Disorder

This study investigates the impact of Developmental Coordination Disorder on the child and its environment in Belgium within the following domains: diagnosis, activities and participation, school, therapy/support, and socio-emotional impact.


Eligibility Criteria:
Inclusion Criteria:

* Parents of children living in Belgium
* Parents of children between 4 and 18 years old
* Parents of children who experience movement problems and/or there is a suspicion or diagnosis of DCD

Exclusion Criteria:

• Parents of children who have another other medical condition that would explain the movement difficulties (e.g. cerebral palsy, muscle disease,...)
Efficacy and Safety of TAK-438 Compared to AG-1749 (Lansoprazole) in the Treatment of Duodenal Ulcer

The purpose of this study is to determine the efficacy of TAK-438, once daily (QD), compared to lansoprazole in patients with duodenal ulcer.


Eligibility Criteria:
Inclusion Criteria:

1. Participants must have endoscopically confirmed duodenal ulcers (mucosal defect with white coating) .At least one ulcer with white coating of 5 mm or larger in size should be observed at baseline (Visit 1).
2. Outpatient (including short inpatient for examination and others)

Exclusion Criteria:

1. Participants with a gastric ulcer which is suspected to be malignant on endoscopy at baseline (Visit 1)
2. Participants with an Acute Duodenal Mucosal Lesion (ADML) on endoscopy at baseline (Visit 1)
3. Participants with a linear ulcer (including scarring) on endoscopy at baseline (Visit 1)
4. Participants with a postoperative ulcer (e.g., Ulcer after EMR/ESD) on endoscopy at baseline (Visit 1)
5. Participants with a gastric ulcer on endoscopy at baseline (Visit 1)
6. Participants with an ulcer for which medical treatment is not indicated (e.g.,perforation, pyloric stenosis, duodenal stenosis, large hemorrhage)
7. Participants who have received endoscopic hemostasis for gastric ulcer within 30 days prior to baseline (Visit 1)
8. Participants with a previous or current history of Zollinger-Ellison syndrome, or other gastric acid hypersecretion disorders
9. Participants who have received or who are scheduled to undergo surgery which affects gastric acid secretion (e.g., resection of upper gastrointestinal tract, vagotomy)
Thumb Carpometacarpal Joint Denervation Versus Trapeziectomy

This is a prospective study tracking the outcomes of patients who undergo either of two treatments for thumb carpo-metacarpal joint arthritis: trapeziectomy with ligament reconstruction (LRTI) or denervation.

A total of 100 patients with carpo-metacarpal (CMC) arthritis will be enrolled in the study. The design of the study is a prospective non-blinded, non-randomized control study. Enrollment will occur at the time of initial clinic visit. All patients presenting with CMC arthritis and deemed appropriate for surgery will be considered for screened for inclusion. As a part of routine workup for CMC arthritis patients receive a hand xray. Specific attendings will perform their preferred technique for CMC arthritis: two perform denervation of the CMC joint, and two perform trapeziectomy with ligament reconstruction tendon-interposition (LRTI) only per their normal clinical practice.

Pre-operative and peri-operative care will be unchanged from standard patient care. Both procedures are outpatient procedures, usually performed under regional anesthesia and patients go home the same day. Patients are discharged with a standard thumb spica splint which is removed on their first clinic appointment which is generally post-operative day 7.

Patients enrolled in the study will have additional follow up at the 3, 6, 12 and 24 month time points. At the 3, 6, 12 and 24 month time points patients will be asked to come to clinic for evaluation with 1) a standard hand questionnaire the Michigan Hand Questionnaire, 2) lateral pinch strength, grip strength and range of motion testing, 3) Kapandji score, 4) visual analog pain scale. Each visit will take approximately 15 minutes. Patients who are unable to follow up in clinic will be given a phone questionnaire with the Michigan Hand Questionnaire, visual analog pain scale and opiate usage. There is no monetary compensation for participation in the study.

Eligibility Criteria:
Inclusion Criteria:

* Adult men and women (\>18 years of age) No prior traumatic thumb injuries (fractures, dislocation) No concurrent thumb procedures scheduled Eaton/Littler stage 2-4 osteoarthritis9 Minimal CMC joint subluxation on x-ray

Exclusion Criteria:

* Traumatic thumb injury (fracture, dislocation) Prior thumb surgery proximal to the interphalangeal joint. Non-fluent English Speaking Planned concurrent procedures on the thumb eg ganglion removal, trigger thumb release
Efficacy Pilot Study of Triflusal in the Attenuation of Insulin Resistance in Human Obesity

To explore the efficacy of triflusal in the attenuation of insulin resistance in human obesity. Triflusal is a salicylate compound approved in several countries as antithrombotic agent (antiplatelet). The hypothesis is to explore if there is a reduction of obesity-induced insulin resistance by triflusal.

Double-blind, randomized, cross-over (three periods) with two dose levels of triflusal, placebo-controlled.

Interventions: treatment periods Triflusal 600 mg/d, 15 days Triflusal 900 mg/d , 15 days placebo, 15 days

Washout period: 30 days

Eligibility Criteria:
Inclusion Criteria:

* Ages 35 to 60 years old
Evaluation of an Orally Administered Medication When Taken in Conjunction With Pramlintide

This is a randomized, single-blind, placebo-controlled, crossover study to examine the effect of pramlintide on the pharmacokinetics of an orally administered medication


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes mellitus treated with diet and/or oral agents
* HbA1c 6.5-11.0
International Prospective Observational Cohort Study for Optimal Bowel Resection Extent and Central Radicality for Colon Cancer

The T-REX study aims to clarify the actual status of metastatic lymph node (LN) distribution in colon cancer and provide reliable evidence regarding the optimal length of bowel resection and the extent of central lymph node dissection in colon cancer surgery.

In colon canser, the incidence of metastasis in the pericolic lymph nodes (LNs) located along the bowel and marginal artery is high. The optimal extent of bowel resection is closely associated with how we define 'regional' pericolic LNs, which should be resected because of the risk of metastasis. However, there are no standardised criteria for 'regional' LNs in the pericolic area.

To establish a consensus for the extent of bowel resection and appropriate central LN dissection, international prospective stdies focusing on the distribution of metastatic LNs along the bowel and the primary feeding artery are conducted.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven colon adenocarcinoma
* Pathological stage Ⅰ, Ⅱ or Ⅲ
* Potentially curative surgery
* Informed consent for observational data collection

Exclusion Criteria:

* Tis (mucosal cancer)
* Multiple colon cancers
* All patients with preoperative adjuvant therapy
Pharmacopuncture Therapy for Cervical Disc Herniation: A Pilot Study

This is pilot study for a 3-arm parallel pragmatic randomized controlled trial that will compare pharmacopuncture therapy, acupunture therapy and physical therapy, medication(prn) for cervical disc herniation.

This is a pragmatic RCT, so the physicians will choose the type and volume of pharmacopuncture, the type and number of acupuncture and the type and time of physical therapy according to participants' conditions, respectively.

Eligibility Criteria:
Inclusion Criteria:

1. Symptoms of cervical disc herniation for less than 12 months
2. Numeric Rating Scale (NRS) of neck pain is more than 5
3. Symptoms of neuromuscular disease in one or both upper limbs (pain, pull, numbness, sensory abnormalities, motor abnormalities)
4. Discrimination findings above protusion, which can explain clinical symptoms on Cervical spine MRI or CT
5. 19-69 years old
6. participants who agreed and wrote informed consents

Exclusion Criteria:

1. Case of being diagnosed with a specific serious disease that may cause neck pain(Migration of cancer reaching to spine, acute fracture of spine, spine dislocation)
2. Progressive neurologic deficits or severe neurologic deficits
3. Cause of pain due to soft tissue disease, not the spine(Cancer, fibromyalgia, RA, goat, or etc.)
4. Other chronic diseases(stroke, MI, kidney disease, diabetic neuropathy, dimentia, epilepsy, or etc.) that may interfere with the interpretation of therapeutic effects or outcomes
5. Participants taking steroid, immunosuppressant, psychotropic medication, or taking other drugs that may affect outcomes
6. Inappropriate or unsafe pharmacopuncture therapy; hemorrhagic disease, taking anticoagulant drug, or severe diabetes patients who are likely to be infected
7. Participants who took NSAIDs or pharmacopuncture, acupuncture, physical therapy within 1 week
8. Pregnant, planning to get pregnant or lactating women
9. Participants who had undergone cervical surgery within 3 months
10. Participants who had participated in other clinical trial within 1 month, had participated in other study within 6 months from the date of selection, or have plan for participation in other trial during follow up period of this trial
11. Participants who can not write informed consent
12. Participants who is difficult to participate in the trial according to investigator's decision
Cryo NerVe Block Extremity AmputatioN RegIStry for Post Operative and pHantom Limb Pain

The goal of this Registry is to see how the device is used when freezing nerves during an amputation procedure.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have or will have an amputation procedure;
* Patients who are willing and capable of providing informed consent;
* Patients whose age is 18 years or above, or of legal age to give informed consent specific to state and national law.

Exclusion Criteria:

* Women of childbearing potential who are, or plan to become, pregnant during the time of the study;
* Other medical, social, or psychological conditions that in the opinion of the Investigator precludes the subject from appropriate consent or adherence to the protocol.
Dexamethasone and Etoricoxib for Pain Prevention Following Periodontal Surgery

The purpose of this study is to investigate whether preemptive medication with dexamethasone or etoricoxib provides better pain management and control than placebo following periodontal surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients presenting moderate or severe periodontitis after nonsurgical periodontal treatment with clinical signs of inflammation

Exclusion Criteria:

* Pregnant
* Diabetes mellitus
* Heart diseases
* Allergic to components of the medications
* Risk of endocarditis
Exploratory Study for Allergy Relief Onset

The purpose of the study is to explore the onset of effect of an antihistamine in a controlled environment.


Eligibility Criteria:
Inclusion Criteria:

* Ambulatory healthy male and female subjects between 18 to 65 years of age inclusive;
* Self-reported to have seasonal allergic rhinitis for at least 2 years prior
* Documented positive skin prick test response to common ragweed (ambrosia artemisiifolia) pollen; prick with wheal \> 4mm larger than the diluent within the previous 12 months
* Total Symptom Score (TSS) ≥ 40 mm at the 90 or 120 minute time point during one of the Priming Visits and at 90 or 120 minute time points during ragweed challenge Symptom Induction Phase of each Treatment Visit;
* Body Mass Index (BMI) in the range of 18 to 30 kg/m2
* Female subjects of childbearing potential must be using a medically acceptable form of birth control for at least 1 month prior to screening (3 months on oral contraceptives), e.g., oral or patch contraceptives, intrauterine device, injectable contraceptive (e.g. Depo-Provera®), or a double barrier and have a negative pregnancy test at Screening and prior to IMP administration on Day 1 and Day 7 ± 1 day. Female subjects of non-childbearing potential must be amenorrheic for at least two years or had a hysterectomy and/or bilateral oophorectomy

Exclusion Criteria:

* Evidence or self-reported history of significant medical condition which, in the judgment of the investigator, is a contraindication to the use of chlorpheniramine, or might interfere with the trial. These may include thyroid disease (e.g., hyperthyroidism, hypothyroidism), uncontrolled diabetes mellitus, coronary heart disease, ischemic heart disease , symptomatic prostatic hypertrophy, bladder neck obstruction, hepatic insufficiency, narrow-angle glaucoma, pyloroduodenal obstruction, or stenosing peptic ulcer;
* Known allergy to chlorpheniramine, dexchlorpheniramine, or any of its inactive ingredients
* Self-reported non-responders (lack of therapeutic effect) to antihistamines
* Administration of epinephrine is contra-indicated;
* Current use of oral steroids, including prednisone and prednisolone;
* Females who are pregnant or lactating
* A history of anaphylaxis to ragweed allergen
* Subjects with a history of asthma, lower respiratory tract disease, emphysema or chronic bronchitis; At the discretion of the investigator, subjects with self-reported mild intermittent asthma or exercise induced asthma may be included.
Trial to Assess the Efficacy of Combination Formula of Aspirin Plus Clopidogrel in Patients With Coronary Stent

The purpose of this study in to evaluate efficacy and tolerability of Clopirin and clopidogrel with aspirin in Korean Patients with post-percutaneous coronary artery intervention.


Eligibility Criteria:
Inclusion Criteria:

* Over 3 months, the patient who were the administration of aspirin or the co-administration of clopidogrel-aspirin coronary artery patients after treated with Percutaneous Coronary Intervention(PCI) that have safety progress.
* Korean men and women between the age of 20 and 85
* Patients who understand the study requirements, are willing to comply with all study procedures and have provided written informed consent.

Exclusion Criteria:

* Patients who were not treated with PCI or intended to treat with PCI but failed.
* Patients who were taking or had taken other antiplatelet or anticoagulant for more than 2 weeks within the prior 30 days.
* Patients who had a history of alcohol abuse or intoxication.
* Patients who had hypersensitivity to clopidogrel or aspirin.
* Patients who had severe hepatic dysfunction aspartate aminotransferase(AST) or alanine aminotransferase(ALT) \> 3 times upper normal reference values.
* Patients who had blood coagulation disorders, uncontrolled severe hypertension, active bleeding, or history of severe bleeding, such as intracranial hemorrhage or ulcer bleeding - surgery within 48hr, platelet counts below 50,000/mm3 in laboratory tests.
* Patients who were pregnant, breastfeeding.
* Patients who were not using effective methods of contraception. (proper contraception : hormonal contraception, condom, intrauterine device, spermicide)
* Patients who medically, psychologically had investigational product administration's prohibition.
* Patients who were not participated in this clinical trial decided by other investigators.
The CBF Study Evaluating the Effect of Betahistine on the Cerebral Blood Flow

Betahistine may provide benefit by enhancement of Cerebral Blood Flow (CBF). This placebo-controlled pharmacodynamic treatment study will primarily explore the effect of betahistine on cerebral blood flow measured by dynamic contrast-enhanced MRI imaging, in a patient population with MRI evidence of cerebrovascular compromise. Also it will be measured if CBF changes correlate with gait and cognitive changes.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects with gait or balance disorder problems
2. Male and female subjects aged on 40 years and above.
3. Absence of known contraindications for betahistine treatment.
4. Currently not on betahistine (of any formulation) treatment for at least 45 days prior to inclusion in the study.
5. Subject consuming caffeinated or alcoholic beverages should have stable consumption throughout the study period.

Exclusion Criteria:

1. History of discontinuation of betahistine treatment (of any formulation) in the past due to lack of efficacy or side effects.
2. Subjects treated with antihistamines and monoamine oxidase (MAO) inhibitors 30 days prior to inclusion in the study.
3. Subjects with hypersensitivity to the active substance or to any of the excipients of the drug.
4. Phaeochromocytoma
5. Porphyria
Suicide Prevention Algorithm in the French Overseas Territories

In France, suicide behaviours are a major public health concern that triggered the creation in 2013 of a National Observatory of Suicide. In continental France, the "Algos" protocol was found to be effective for the prevention of suicide attempts reiterations. This protocol is based on a procedure that keeps telephone and postal contacts with the suicide attempter and allows, via an algorithm, to assess the risk of suicide attempt recurrence, in order to intervene if necessary. Nevertheless, Algos does not involve primary care health practitioners, who could add a substantial additional efficacy, especially if they intervene downstream and in supplement to Algos. In addition, this kind of protocol has never been evaluated in the French overseas territories.

Since (1) Algos was never implemented in the French overseas departments (FOD) and does not involve primary care practitioners (PCP), (2) the additional effect of PCP involvement over and beyond Algos alone in unknown, and (3) little research on suicide behaviours has been conducted in the FOD, this proposal has the following main aim: to assess the effectiveness and the efficacy of the intervention, in supplement and downstream to Algos, of a healthcare professional, on the recurrence of suicide attempts in the FOD; the healthcare professional will be the patient's general practitioner, whenever possible.

Eligibility Criteria:
Inclusion Criteria:

* Man or woman over 16 years of age
* Leaving the hospital within 15 days of the suicide attempt
* Giving (him/herself or his/her legal representative)an oral consent to participate in the study
* Having healthcare insurance
* Reachable by phone, with possibility of confidential conversation, and by mail
* Resident of Guadeloupe, French Guyana, Martinique, or Reunion Island
* Able to understand and speak French

Exclusion Criteria:

* Homeless person
* Disabled adult, person under judicial/court protection, legally incompetent adult
* Participant unable to understand the study protocol, its risks and side effects, or declining to participate