cyrilzakka/clinical-trials huggingface dataset:
The EFFect of hIgh Dose ClopIdogrel treatmENT in Patients With Clopidogrel Resistance

Continuing high dose clopidogrel treatment after elective PCI decreased adverse cardiac events in patients with clopidogrel resistance

Aim:

Primary objective:

* To evaluate the effect of continuing high dose clopidogrel treatment on adverse cardiac events after elective PCI in patients with clopidogrel resistance

Secondary objective:

* To evaluate the effect of continuing high dose clopidogrel treatment on adverse cardiac events after elective PCI
* To evaluate the effect of continuing high dose clopidogrel treatment on bleeding complications after elective PCI
* To evaluate the clinical effect of VerifyNow which use as a clopidogrel resistance kit.

Study central:

Bursa Postgraduate Hospital, Cardiology Clinic

Study population:

we planned to enrol 180 patients. 50% of patients without clopidogrel resistance (control group: 90 patients) 50% have clopidogrel resistance. Than we randomise the patients (with clopidogrel resistance) in two groups (group 1:45 patients (75mg/day), group 2:45 patients (150mg/day))

inclusion criteria:

* The patients; who have planned elective PCI and have had written informed consent for participation to study.
* Age\>18 year-old,
* The native coronary artery;lesion with narrowing \>=70%

Exclusion criteria:

* Patients have allergy for ASA, Clopidogrel and heparin
* Patients who performed primary PCI
* Patients with acute coronary syndrome
* Patients with have a history of PCI and use clopidogrel
* Patients on warfarin therapy
* Patients who have bleeding diathesis, or have high risk for bleeding.

Study works:

* Write case report form for all patients
* Control for inclusion criteria.
* Evaluate the clopidogrel and ASA resistance with VerifyNow kit. Than randomised the patients.
* Demographic data (age, gender)
* Height, weight, BMI and GFR
* Risk factors
* laboratory data (biochemical and hematologic)
* Medication history
* Echocardiographic data
* Angiographic data
* PCI data(vessel diameter, stent diameter, lesion and stent length, performed PTCA or not, etc)
* Note complication (MACE, bleeding, hematoma etc)

  4 weeks later note the first control data and re assess the clopidogrel resistance with VerifyNow kit in patients groups 1 and 2.

Six months later note the second control data.

Eligibility Criteria:
Inclusion Criteria:

* The patients; who have planned elective PCI and have had written informed consent for participation to study.
* Age\>18 year-old,
* The native coronary artery;lesion with narrowing \>=70%

Exclusion Criteria:

* Patients have allergy for ASA, Clopidogrel and heparin
* Patients who performed primary PCI
* Patients with acute coronary syndrome
* Patients with have a history of PCI and use clopidogrel
* Patients on warfarin therapy
* Patients who have bleeding diathesis, or have high risk for bleeding.
Minocycline to Reduce Pain After Carpal Tunnel Release

The investigators are looking at whether peri-operative minocycline will reduce the duration of pain after minor hand surgery: carpal tunnel release and trigger finger release.

The investigators' hypothesis is that minocycline will reduce post-operative pain.

This is a double blinded randomized controlled trial. Patients are given 100mg of minocycline 2 hours prior to their procedure and then 100mg two times a day for 5 days. The subjects are then contacted daily to check their level of pain. The investigators' outcome of interest is time to pain resolution.

The investigators will perform a futility analysis to assess if a larger trial would be a reasonable next step after this pilot study.

Eligibility Criteria:
Inclusion Criteria:

* Adult, Veteran,

Exclusion Criteria:

* Kidney failure, Liver failure, thrombocytopenia, ALS, SLE, Frailty, unable to understand survery
Beneficial Effects of Long Term Menaquinone-7

From all K-vitamins, menaquinone-7 (MK-7) has been identified now as the most effective cofactor for the carboxylation reaction of Gla-proteins such as osteocalcin (in bone) and matrix-Gla protein (in the arterial vessel wall). The question remains whether supplementation with MK-7 also leads to measurable improvements of bone and vascular health. The purpose of the study is to demonstrate that MK-7 has a health benefit in apparently healthy postmenopausal women. In a placebo-controlled randomized clinical trial the effect of an MK-7- supplement will be monitored during three years on bone quantity and quality and on vascular characteristics and function.


Eligibility Criteria:
Inclusion Criteria:

* Healthy postmenopausal women between 55 and 65 years old
* Subjects of normal body weight and height according to BMI \< 30
* Subjects of Caucasian race
* Subject has given written consent to take part in the study

Exclusion Criteria:

* Subjects with (a history of) metabolic or gastrointestinal disease
* Subjects presenting chronic degenerative and/or inflammatory disease
* Subjects receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters
* Subjects receiving corticoϊd treatment
* Subjects using oral anticoagulants
* Subject using bisphosphonates
* Subjects using hormone replacement therapy
* Subjects undergoing ovariectomy and/or hysterectomy
* Subject with (a history of) soy allergy
* Subjects using vitamin K containing multivitamins or vitamin K supplements
* Subjects who have participated in a clinical study more recently than one month before the current study
* Subjects who are found to be osteoporotic at baseline (T-score \< -2.5)
REsponsiveness to CLOpidogrel and Stent-related Events in Acute Coronary Syndromes (RECLOSE 2 - ACS)

The main objective of the project is to assess the long-term prognostic impact of residual platelet reactivity after optimal antiplatelet therapy in a large cohort of patients with acute coronary syndrome undergoing invasive strategy.

Follow-up length will be at least 24 months. The primary end-point of the study will be a composite of death, myocardial infarction, urgent target vessel revascularization, stent thrombosis or stroke.

This study is mainly based on a registry of 2000 consecutive patients with acute coronary syndrome who received invasive treatment and for whom platelet reactivity after clopidogrel treatment will be prospectively assessed.

In the acute phase, blood samples for platelet reactivity assessment will be obtained 12 to 18 hours from 600 mg clopidogrel loading. Platelet-rich plasma, obtained by centrifuging whole blood for 10 min at 200 g, was stimulated with 10 M adenosine 5'-diphosphate (ADP) and residual aggregation will be assessed using a APACT 4 light transmittance aggregometer. Platelet aggregation (according to the Born's method) will be evaluated considering the maximal percentage of platelet aggregation in response to stimulus. Patients with platelet aggregation by 10 µmol ADP ≥ 90th percentile of controls (70%) will be defined as non-responders. The assessment of platelet reactivity will be repeated at 6 months. The importance of concomitant aspirin resistance will be also evaluated in such of patients.

Eligibility Criteria:
Inclusion Criteria:

* acute coronary syndrome
* invasive treatment

Exclusion Criteria:

* in-hospital death that was not due to stent thrombosis,
* anticipated poor compliance to dual antipletelet treatment for at least 6 months,
* premature discontinuation of clopidogrel therapy.
Comparison of Two Regimens of Dexamethasone in the Prevention of Hypersensitivity Reactions to Paclitaxel, a Pilot Study

This is a prospective, randomized, unicentric, two-arm, parallel, controlled, and double blind pilot study.

The purpose of this pilot study is to assess the feasibility of a trial designed to compare the quality of life of patients taking dexamethasone in two different ways to prevent hypersensitivity reactions to paclitaxel.

Dexamethasone given intravenously (IV) 30 minutes before paclitaxel could improve quality of life, could adequately prevent hypersensitivity reactions to paclitaxel and could reduce adverse effects compared to dexamethasone given orally 12 hours and 6 hours before paclitaxel.

Primary objective:

To assess the feasibility of a randomized, parallel, two-arm, controlled and double blind trial designed to compare the quality of life of patients taking dexamethasone 20 mg IV 30 minutes before paclitaxel with those taking a standard dose of dexamethasone, 20 mg orally 12 hours and 6 hours before paclitaxel, in patients taking paclitaxel every two to three weeks for a minimum of two cycles in order to estimate a sample size.

Secondary objectives:

Between the two study groups, to compare:

* Quality of life during the first two cycles of chemotherapy;
* Efficacy of dexamethasone in preventing acute hypersensitivity reactions to paclitaxel in the first two cycles of chemotherapy;
* Adverse effects associated with dexamethasone on a daily basis during the first seven days of the first two cycles of chemotherapy.

Eligible patients will be randomized in a 1:1 ratio to one of the two study groups.

Eligibility Criteria:
Inclusion Criteria:

* Patient treated at the outpatient clinic or admitted to the oncology unit of Notre-Dame Hospital between February 4, 2013 and July 19, 2013;
* Patient diagnosed with cancer;
* Patient starting a chemotherapy containing paclitaxel every two to three weeks for a minimum of two cycles;
* Patient aged 18 years and over;
* Patient able to give free and informed consent and who agrees to participate by signing the consent form;
* Patient able to complete the questionnaire on quality of life EORTC QLQ-C30 and the personal logbook.

Exclusion Criteria:

* Patient unable to speak English or French;
* Patient who has previously received paclitaxel;
* Patient receiving a prescription of paclitaxel bound to albumin;
* Patient is currently under treatment with systemic corticosteroids or has received systemic corticosteroids during the last week;
* Patient in another research protocol evaluating a different chemotherapy regimen;
* Patient who had an allergic reaction to taxanes;
* Patient with severe intolerance to lactose;
* Patient with an allergy or a severe intolerance to products containing castor oil (eg.: cyclosporine and vitamin K).
Efficacy of Gamification in Enhancing User Engagement

As part of Phase II of the NIH SBIR grant, the study will conduct a randomized controlled clinical trial in which the MapHabit system's gamification is investigated to determine whether the assistive technology facilitates user engagement and retention. Additionally, the study will examine if the gamified software improves the quality of life of persons with dementia and reduce the burden of the respective care partners. Participants will be individuals with Alzheimer's disease or related dementias in mild to moderate stage of cognitive impairment, in tandem with their respective care partner (i.e., primary familial caregiver). The study will be a randomized controlled clinical trial, in which three conditions will be investigated: 1) experimental condition in which MHS+G is implemented into the daily care received by participants 2) control condition in which the MHS alone is incorporated into the participant's daily care 3) exploratory condition where virtual reality gamification is incorporated into the MHS+G experience. The sample size will be a total of 40 individual-caregiver dyads, 20 in each condition-5 of the 20 subjects in the experimental condition will be included in exploratory condition. The study duration will be a 6-month intervention.


Eligibility Criteria:
Inclusion Criteria:

* Individual diagnosed with Alzheimer's disease or other related dementia (ADRD) in their mild to moderate stage of impairment
* Participating caregiver of individual with dementia must be the primary caregiver
* Proficient in English

Exclusion Criteria:

* Individual not diagnosed with ADRD
* Participating caregiver of individual with dementia is NOT the primary caregiver
* Not proficient in English
A Clinical Trial of Fecal Microbiota Transplantation in a Population With Obsessive-compulsive Disorder

Obsessive-compulsive disorder (OCD) is a psychiatric condition marked by recurrent intrusive thoughts (obsessions) and ritualistic behaviors aimed at reducing distress (compulsions). While there exist a number of medications to treat this illness, half of those who need them either do not respond or can not tolerate current medications because of side effects. Therefore, there is an urgent need to develop new ways to treat this illness. One of the areas being explored as a potential option is based on what is now known as a strong link between the bacteria that live in our gut and the brain. Research has shown that a fecal transplant of the gut bacteria from healthy donors is able to improve health outcomes for people with depression and the investigators now want to expand this into OCD, given a known link between this condition and bacterial infection. To do this the investigators will use both the standard methods of bacterial identification via stool analysis, which looks at large bowel changes, and compare it to the Small Intestine Microbiome Aspiration (SIMBA) system, a small capsule that when swallowed allows a fluid sample to be collected from the participants' small intestine. This work will help the investigators assess the benefits of fecal transplant in OCD, and more importantly, identify how transplant changes the system, utilizing a novel technology to move the field forward.


Eligibility Criteria:
Inclusion Criteria:

* Adults who have a primary diagnosis of OCD
* on a stable appropriate dose of (SSRI) treatment for at least 12 weeks prior to Baseline
* insufficient response to current SSRI treatment indicated by persistence of symptoms.

Exclusion Criteria:

* Participant meets Diagnostic criteria for substance use, eating disorder, schizophrenia, or schizoaffective disorder
* Suicidality
* regular intake of antibiotics, prebiotics, or probiotics
* Clinically diagnosed with IBD, Crohn's disease, Ulcerative colitis, or Celiac disease
* Immune suppression
* intestinal obstruction
* Oropharyngeal dysphagia or other swallowing disorder
* \< 2 bowel movements per week
* Breastfeeding, pregnant or seeking to get pregnant during the course of this study
Exercise Capacity in Non-cystic Fibrosis Bronchiectasis After a Pulmonary Rehabilitation Home-based Program

A number of studies have described low exercise capacity and physical activity in patients with non-cystic fibrosis bronchiectasis (non-CF Bronchiectasis), although little research exists on using the cardiopulmonary exercise test (CPET) to evaluate exercise capacity and its most relevant changes after a pulmonary rehabilitation home-based program (PRHP). In addition, few studies have addressed tolerance to exercise and physical activity in severe cases of the disease.

Aims:

To evaluate the exercise capacity of non-CF BQ patients using CPET and physical activity after a pulmonary rehabilitation home-based program.

Methodology:

Our study describes a non-pharmacological clinical trial in non-CF BQ patients at the Virgen Macarena University Hospital (Seville, Spain). The patients were randomized into two groups: the control group (who were provided with training instructions) and the intervention group (who took part in a specific pulmonary rehabilitation home-based program).

A signed informed consent form was provided prior to inclusion in the study. The data evaluated was obtained under strict confidentiality rules. All patients passed an initial assessment of the degree of physical activity by means of accelerometers, as well as pulmonary function tests and exercise tolerance (CPET) and 6MWT, stratification severity according to the E-FACED scales, quality of life using the saint george respiratory questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Certain diagnosis of non-CF bronchiectasis (chest HRCT)
* Over 18 years old, clinically stable in the previous 6 weeks (no need for antibiotic therapy due to exacerbations) and a dyspnea score over 1 according to the modified Medical Research Council (mMRC) dyspnea scale

Exclusion Criteria:

* Less of 18 years
* Other airway disease ( Asthma or COPD)
* Physical inability to perform a physical training program (neuromuscular pathology or residual injuries).
* Smokers or former smokers of less than 6 months or with a history of consumption of 15 packs/year.
* Cystic fibrosis.
* Active infections (bronchopulmonary aspergillosis, pulmonary tuberculosis).
* Active tuberculosis.
* Medical illnesses that put the individual at risk of a decompensation due to the performance of any physical activity or cardiopulmonary stress test (unstable ischemic heart disease, acute myocardial infarction less than 1 month).
* Pregnancy
* Mental disorder that prevents the adequate interpretation of the indications or performance of the tests.
* Attended pulmonary rehabilitation within 1 year.
Using Heart Rate Variability Biofeedback to Improve Attention and Memory in PTSD+ Combat Veterans

This study will test the effectiveness of Heart Rate Variability (HRV) Biofeedback as a therapeutic tool in the reduction of everyday memory problems routinely experienced by combat veterans with Posttraumatic Stress Disorder (PTSD). The study is innovative in three ways: (1) through its investigation of the clinical use of a novel PTSD treatment technology, (2) by focusing on the understudied aspect of the daily functioning of PTSD veterans, and, (3) by investigating a heretofore untested application of biofeedback for PTSD induced deficits in attention (ATTN) and immediate memory (IM). Though HRV Biofeedback has proven successful for several applications in the general population, the idea that deficits in ATTN/IM in combat veterans with PTSD can be remedied by normalization of HRV has not yet been tested empirically. HRV is functionally incorporated into attentional processes, essentially operating as an index of autonomic flexibility and the ability to self-regulate in response to stimulation from the environment. Low HRV occurs in patients with PTSD, General Anxiety Disorder, and Coronary Artery Disease, and is correlated with negative affect and hostility. HRV Biofeedback training has been shown to be effective in increasing HRV in these groups of patients, as well as improving psychological well-being and physiological function in patients with Depression, Fibromyalgia, and Cardiovascular Disease. Therefore, the interrelationship between HRV and ATTN/IM problems in PTSD+ Combat veterans warrants further investigation. If HRV Biofeedback significantly improves ATTN/IM in these subjects, then it can be offered to VA clinicians treating combat PTSD as an effective new treatment tool.


Eligibility Criteria:
Inclusion Criteria:

* OIF/OEF veterans with PTSD

Exclusion Criteria:

* Neurologic disorder
* Active substance abuse
Genotropin Treatment In Very Young Children Born Small For Gestational Age

To demonstrate the effect on height and psychomotor development of Growth Hormone treatment in very young children starting at an age of 2 years.


Eligibility Criteria:
Inclusion Criteria:

Caucasian male or female subjects aged between 19-29 months at Screening Visit 1.

Born SGA (birth length and/or weight \<-2 SD for gestational age, using country-specific standards).

Height below -2.5 SD at screening (19-29 months of age). At least one measurement of length between 12 and 18 months of age. Normal karyotype in girls to exclude Turners syndrome.

Exclusion Criteria:

Severe Intra-Uterine Growth Retardation (IUGR) (birth length below - 4 SD for gestational age), if associated with dysmorphic features.

Severe prematurity (Gestational Age (GA) \<32 weeks of gestation). Ongoing catch-up growth (defined as growth velocity SDS at inclusion \>0) based on at least 4 months measurement interval).

Severe familial short stature defined as: Father's height below 155 cm or mother's height below 145 cm.

Defined neurological defects and/or severe neurodevelopmental delay.
Manual Therapy/Exercises vs. Physiotherapy/Back School vs. Waiting List in Patients With Chronic Low Back Pain

A randomized controlled trial for patients with chronic low back pain with two treatment arms and one waiting list control group. Primary outcome is pain intensity on VAS.


Eligibility Criteria:
Inclusion Criteria:

* pre-existing and specialist confirmed diagnosis of chronic low back pain for at least 3 months prior to inclusion
* Average pain intensity with at least 40 mm on the VAS from 0 to 100 mm and pain on at least 5 of 7 weekdays in the last 3 months.

Exclusion criteria:

* Regular own exercise practice for the treatment of back pain (including yoga and other interventions)
* Invasive spinal procedures within the past 6 weeks or planned within the next 10 weeks
* Acute disc herniation (diagnosed within the last 3 months)
* Congenital deformities of the lumbar spine
* Rheumatoid arthritis
* Fibromyalgia
* Ankylosing spondylitis
* Severe comorbidities
* Pregnancy/lactation
* Current participation in another clinical trial
Erector Spinae Plane Block Versus Serratus Anterior Plane Block

the aim of the study compare the analgesic effect of erector spinae block and serratus anterior block in breast surgery

Breast reduction surgery is a common cosmetic surgical procedure. Providing effective analgesia has a crucial role in reducing side effects, catalyzing postoperative recovery, and increasing patient satisfaction. Regional anesthesia techniques are generally used for postoperative analgesia to decrease opioid-related side effects. Fascial plane block has gained popularity for breast analgesia. The investigator aimed to consider the effects of ESP block or Serratus Anterior Plane block on postoperative analgesia in breast reduction surgery.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) I-II,
* 18-65 years of age, adult,
* female patients
* undergoing elective breast reduction surgery

Exclusion Criteria:

* Allergy to amide-type local anesthetics
* Infection at the block injection site
* Severe obesity (BMI \> 35 kg/m2)
* Liver or renal deficiency
* Patients with anatomical deformities
* Recent use of analgesic drugs
* Patient refusal or inability to consent