cyrilzakka/clinical-trials huggingface dataset:
Interests of Strengthening Isokinetic Upper Extremity Hemiparetic Sequelae in Patients

Stroke (CVA) is the leading cause of death and the leading cause of disability in developed countries as in developing countries (WHO, 2000). In the aftermath of a stroke, patients keep a permanent disability in 75% of cases and only one quarter of them is able to resume work. The post stroke sequelae are sensory-motor and cognitive.

According to literature data, 75-83% of patients who survive a stroke learn to walk only 25 to 45% recover use of their upper limb in activities of daily living (Friedman, 1990).

The existence of a phase called "plateau" in motor recovery after stroke has been suggested (Colautti, 2001). This would occur beyond the 4 th month and would correspond to a phase where the rehabilitation techniques used in the subacute phase are deemed less effective. Recently, Page (2004) speculated that this plateau phase is rather the consequence of adaptation to the type of patient follow-up training and not that of a limit to the possibilities of recovery. In an observational study on the recovery of upper limb conducted over a period of 4 years, Broeks (2004) showed a possible recovery beyond 16 weeks post stroke. The results of studies on different techniques for rehabilitation of chronic stroke patients tend to confirm the hypothesis of page. Therefore, varying the training parameters (type, intensity, frequency) could improve the functional capabilities of these patients, even at a distance of stroke.

Strength training is part of the management of hemiparetic patients. The results of several studies show an improvement in muscle strength and functional ability to walk after a building program isokinetic lower limb (Sharp, 1997).

The objective of our project is to evaluate the effectiveness of a building program of isokinetic muscle on the paretic limb motor recovery in hemiparetic patients over 6 months of a stroke.


Eligibility Criteria:
Inclusion Criteria:

* Patients with more than 6 months post stroke,
* Muscular control greater than or equal to 3 on the extensors and elbow flexors,
* Muscular control greater than or equal to 3 on the flexors and extensors of the wrist,
* Spasticity less than or equal to 3 on the muscle groups mentioned above, s
* Active abduction of the shoulder above 60 ° and painless
* Absence of cognitive impairment (MMS\> 22 without any trouble phasic)
* No orthopedic limitations at the elbow and wrist,

Exclusion Criteria:

* Progressive neurological or systemic involvement,
* Orthopedic limitations at the elbow or wrist
* Cognitive,
* Hemineglect,
* Severe aphasia with impaired comprehension,
Necessity of Antibiotics for Prevention of Delivery-associated Infections After Spontaneous Vaginal Delivery at Term

The purpose of this study is to determine amoxicillin is effective in the prevention of wound infection in normal labor.

When the pregnant women is admitted due to first stage of labor , the investigator will inform the patients. If the patients give consent, the patient's data will be collect in case record form. the patients will be swab at posterior fornix and around anus to collect specimen and send to microbiology lab before per vaginal examination. After the patients finish in labor, perineal wound will be swab to collect specimen and send to microbiology lab. Then the patients are randomized in two group, the first one will receive amoxicillin and the second one will receive placebo. During admission the patients will be exam by investigator every day. After the patients are discharge, the follow up will be appoint on 6 weeks later. The infant will be swab at rectum to collect specimen and send to microbiology lab when the patient's discharge day. Every specimen will be culture for bacteria and perform antimicrobial susceptibility test for amoxicillin.

Eligibility Criteria:
Inclusion Criteria:

* Term pregnancy
* Normal labor

Exclusion Criteria:

* Penicillin allergy
* Previous history antibiotic using within 2 weeks
* Patients cannot take oral medication
* Patients have underlying disease eg. diabetes mellitus, hypertension, HIV infection
* Premature rupture of membranes
Assessing Tolerability of Avonex Intramuscular Injections

The purpose of this study is to evaluate patients' views when injecting Avonex intramuscularly.


Eligibility Criteria:
Inclusion Criteria:

* Between 18 - 65 years of age;
* Confirmed diagnosis of Relapsing Remitting Multiple Sclerosis;
* Currently being treated with Avonex® for at least 90 days;
* Using 25 gauge needles for injection of Avonex® for at least 90 days;
* Willing and able to complete study questionnaires; and
* Provided informed consent to participate in this study

Exclusion Criteria:

* Diagnosis of Progressive Multiple Sclerosis;
* History of recent illness or infection;
* History of allergic reaction to Avonex®;
* Any prior usage of a 30 gauge needle for administration of Avonex®;
* Concurrent treatment with other immunomodulating therapies;
* Pregnant or planning on becoming pregnant;
* Nursing mothers; and
* Unable to complete the requirements of the study
GDNF Gene Therapy for Multiple System Atrophy

The objective of this randomized, double-blinded, placebo-controlled Phase 1 investigation is to evaluate the safety and potential clinical effect of AAV2-GDNF delivered to the putamen in subjects with either a possible or probable diagnosis of Multiple System Atrophy.


Eligibility Criteria:
Inclusion Criteria:

* Male and female 35-75 years of age (inclusive)
* Clinical diagnosis of MSA, parkinsonian type with symptoms onset sporadic, progressive and \> 30 years of age
* Less than 5 years from MSA parkinsonian diagnosis with expected survival more than 3 years
* Stable anti-parkinsonian medication regimen
* Ability to walk a distance of 25 feet with or without an assistive device

Exclusion Criteria:

* Presence of idiopathic Parkinson's disease (PD) or any PD-related mutation or other neurological diseases
* Presence of dementia, psychosis, substance abuse or poorly controlled depression
* Prior brain surgery (i.e., deep brain stimulator implantation) or other brain imaging abnormalities
* History of cancer or poorly controlled medical conditions that would increase surgical risk
* Received investigational agent within 12 weeks
* Inability to tolerate laying flat in an MRI and/or allergy to gadolinium

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Treatment of Postnatal Depression for Low-Income Mothers in Primary Care in Santiago, Chile

A randomized clinical trial was carried out at primary care level in Santiago, Chile to investigate a combined treatment for women suffering post-natal depression and preventing the adverse consequences of this illness on infant's growth and development.

Background: We compared the effectiveness of a multi-component intervention with usual care to treat postnatal depression among low-income mothers in primary care clinics in Santiago, Chile.

Methods: Randomised controlled trial. Two hundred and thirty mothers with major depression attending postnatal clinics were randomly allocated to either a multi-component intervention or usual care. The multi-component intervention involved a psychoeducational group, treatment adherence support, and pharmacotherapy if needed. Data were analysed on an intention-to-treat basis. The main outcome measure was the Edinburgh Postnatal Depression Scale (EPDS) at 3 and 6 months after randomisation.

Eligibility Criteria:
Inclusion Criteria:

* Mothers meeting criteria for current DSM-IV major depression were eligible.

Exclusion Criteria:

* who had received any form of treatment for their depression during their current postnatal period,
* those who were pregnant,
* with psychotic symptoms,
* serious suicidal risk,
* history of mania,
* alcohol or drug abuse
Study of Two Surgical Drilling Techniques to Treat Juvenile Osteochondritis Dissecans of the Knee

The purpose of this study is to compare the functional, clinical and radiographic outcomes associated with trans-articular drilling versus retro-articular drilling, two commonly employed techniques of operative treatment for stable forms of juvenile osteochondritis dissecans (JOCD) lesions. This study also aims to better define the natural history of this condition in its most commonly identified pathological state (as a stable lesion) following surgical intervention by determining the rate of radiographic healing and any need for secondary surgery.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of JOCD,
* Lesion located on the lateral aspect of the medial femoral condyle,
* Lesion considered stable based on MRI,
* Patient deemed skeletally immature based on MRI,
* Completed a course of conservative therapy.

Exclusion Criteria:

* Significant concomitant knee pathology (AVN, fracture, inflammatory arthritis, ACL tear, discoid/meniscal tear, etc.)
* Lesion healed sufficiently and surgery is not recommended,
* Prior surgery on the affected knee,
* Diagnosis of metabolic bone disorder (e.g. osteogenesis imperfecta),
* Diagnosis of sickle cell disease,
* History of prolonged corticosteroid or chemotherapy treatment,
Understanding Risk Perception, Behaviour, and Attitudes Related to Other New Tobacco Products Among Youth

To understand the risk perception, behaviour, and attitudes related to electronic cigarettes and other tobacco products among youth.

Phase I Individual qualitative interviews will be conducted to understanding the needs and concerns of youth smokers of e-cigarette or other new tobacco products, including their risk perceptions, and the behaviour, attitudes, and experiences related to these products.

Phase II The findings from the interview in phase I will guide the development of a structure questionnaire for a cross-sectional survey to further explore the behaviour, attitudes, and experiences related to e-cigarette or other new tobacco products among youth.

The findings of this study have important implications for research and clinical practice. Understanding how youth smokers perceive the risks of using e-cigarette and other new tobacco products, and their behaviour, attitudes, experiences related to smoking to help them achieve smoking abstinence. Moreover, the results of this study can understand the misconceptions about e-cigarette and other new tobacco product among youth, increase their perception of the risks of continued smoking and benefits of quitting.

Eligibility Criteria:
Inclusion Criteria:

* Youth smokers who contacted the Youth Quitline will be eligible to be included in this study if they (1) are ethnic Chinese; (2) are aged ≤ 25 years; (3) are ever user of e-cigarette or any new tobacco products; and (4) spoke Cantonese.

Exclusion Criteria:

* psychologically or physically unable to communicate
Insulin Pump Therapy and Continuous Glucose Monitoring in Diabetic Continuous Ambulatory Peritoneal Dialysis (CAPD) Patients

The aims of this study are to assess the potential efficacy and safety of insulin pump to improve glycemic control in conjunction with continuous glucose monitoring (CGMS) for diabetic continuous ambulatory peritoneal dialysis (CAPD) patients.

Diabetic nephropathy now accounts for 20% to 40% of all patients entering end-stage renal failure (ESRF) programs. The quality of glycemic control is known to be an important determinant of the rate of progression of patients with diabetic continuous ambulatory peritoneal dialysis (CAPD) patients. Diabetic CAPD patients are usually treated with dialysis fluids utilizing glucose as the osmotic agent to provide ultrafiltration. Most of diabetic CAPD patients had HbA1c readings above 7% despite the recommendation to keep the reading below 7%.

The continuous blood glucose monitor (CGMS) has recently offered an opportunity to monitor blood glucose at 5-minute intervals for 72 continuous hours in diabetic patients. The CGMS patterns reveal blood glucose tracings well above the recommended standards of control in most of the diabetic CAPD patients.

Good glycemic control is often difficult to maintain in diabetic patients treated with CAPD because they are continuously exposed to high concentrations of glucose in peritoneal dialysate. However, recent studies have suggested that diabetic patients who use insulin pump has been shown to reduce glycated hemoglobin levels without an increased risk of hypoglycemia, as compared with a regimen of multiple daily insulin injections, but results in diabetic CAPD patients have not been reported.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 - 70 years old at registration
2. Type 1 or Type 2 Diabetic CAPD patients for at least 3 month and less than 60 months
3. Hemoglobin A1c of at least 7.5% at registration Kt/V is greater than 1.7

Exclusion Criteria:

1. Have peritonitis in recent 3 months other active bacterial infections
2. Unstable clinical conditions or evidence of malignancy
3. Pregnancy
4. Non-diabetic ESRD patients
5. Individuals already receiving diabetes therapy via an insulin pump
Effect of Early Enteral Nutrition on Serum Acetylcholine Level and Inflammation in Critically Ill Patients

Early enteral nutrition(EEN) is an important treatment for critical ill patients and attenuate systemic inflammation, but the mechanisms are not clear. Thus the investigator conducted this study to observe if EEN affects systemic inflammation though regulation of blood acetylcholine


Eligibility Criteria:
Inclusion Criteria:

* initiating enteral nutrition within the first 24-48h after intensive care unit (ICU) admission
* age more than 18 years
* Acute Physiology and Chronic Health Evaluation II (APACHE II) score \>8

Exclusion Criteria:

* not expected to survive 24 hours
* pregnancy
* any terminal stage disease
Neuroimaging and Neuromonitoring in Critically Ill Children With Sepsis

In critically ill children with severe sepsis, neurophysiologic derangements often proceed undetected and can lead to irreversible brain injury causing neurocognitive and behavioral deficits. The etiology of these impairments is unclear, however, it is likely that some of this neural injury is preventable. The overarching goal for this study is to show that acute acquired structural and microstructural brain injury occurs in critically ill children with severe sepsis, and that this injury is related to neuropsychological deficits and impaired cerebral autoregulation (CAR). Subjects will complete Magnetic resonance (MR) imaging within 2-10 days of recognition of their severe sepsis. Subjects will undergo serial interrogation of CAR for up to 10 days. CAR will be determined by the correlation of arterial blood pressure with middle cerebral artery flow velocity measured by transcranial doppler ultrasonography and cerebral oximetry derived from near-infrared spectroscopy. Subjects will also participate in a neuropsychological evaluation 6 months after enrollment to evaluate multiple domains of behavior and cognition.


Eligibility Criteria:
Inclusion Criteria:

* Admission to the Children's Hospital of Philadelphia (CHOP) pediatric intensive care unit (PICU)
* Males or females ages ≥ 3.5 years and ≤ 18 years on day of sepsis recognition
* Meet published consensus criteria for severe sepsis or septic shock: a) ≥ 2 systemic inflammatory response syndrome criteria, b) suspected (based on attending physician) or confirmed systemic infection, and c) ≥ 2 or more organ system dysfunctions (severe sepsis) or cardiovascular dysfunction (septic shock).
* An indwelling arterial catheter.
* Parental/guardian permission (informed consent).
* The patient and parent/guardian are fluent in English.

Exclusion Criteria:

* History of neurologic disorder including (hypoxic ischemic injury, traumatic brain injury, epileptic encephalopathy, neurodevelopmental, neurometabolic or neurogenetic conditions, and structural brain anomalies).
* History of cancer or undergoing treatment for cancer.
* Meningitis or encephalitis as source of sepsis.
* Congenital heart disease.
* History of cardiac arrest.
* History of extracorporeal membrane oxygenation (ECMO) cannulation.
* Patients with contraindications to MR scanning.
* Pregnant or lactating females.
* Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
* Previous enrollment in this study.
Safety and Efficacy of Adaptive DBS Vs Conventional DBS in Patients With Parkinson's Disease

This is an exploratory study to preliminary assess safety and efficacy of an adaptive Deep Brain Stimulation (DBS) closed-loop method in patients with PD.

The study has been designed as a double blind randomized crossover trial that uses conventional DBS as a concurrent control in PD patients in need of Implantable Pulse Generator (IPG) replacement.

PD patients in need of IPG replacement will be screened to identify the ones eligible for enrollment.

Randomized patients will undergo 2 days of experimental sessions (i.e. one per each type of stimulation mode, cDBS and aDBS), in a well-controlled environment (i.e. during hospitalization). During each experimental session experienced neurologists will collect information on safety and efficacy endpoints.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of idiopathic PD;
* DBS implant since at least 3 years and in need of battery replacement, defined by battery level \<25%;
* Patients must be able to sign the informed consent document to participate in the clinical trial;
* Patients with a suboptimal response to DBS treatment.

Exclusion Criteria:

* Patients with severe cognitive decline (MMSE \<25);
* Patients with major psychiatric issues;
* Patients with any medical condition potentially interfering with DBS battery replacement surgery;
* Patients that cannot tolerate an interruption of DBS stimulation;
* Patients taking only one levodopa dose per day;
* Patients with no LFPs recorded from any contacts pair, during intraoperatory IPG replacement procedure;
* Pregnant or breastfeeding women.
Post Market Clinical Follow-Up Study of Excia T® Hip Prosthesis

Clinical and radiological 10 year results of Excia T® Hip Stem


Eligibility Criteria:
Inclusion Criteria:

* Patient gave written informed consent
* age ≥ 18 years

Exclusion Criteria:

* pregnancy
Influence of Gum Disease Treatment on Long-term Dental Implant Success

The aim of this study is to evaluate the influence of periodontal care response on long term dental implant success. Investigator's hypothesis is that patients who do not well respond to periodontal care have more chance to develop peri-implant complications at long-term. The second purpose of this study is to evaluate the influence of other local, systemic, behavioral, and implant's related risk factors


Eligibility Criteria:
Inclusion Criteria:

Patient attending supporting periodontal therapy with at least one implant placed for more than 3 years

* Patient with more than 12 teeth at baseline
* Patient with demographic, periodontal, implant data recording
* patient aged \>30 years at Baseline

Exclusion criteria:

* Patient needed antibiotic prophylaxis
* Uncontrolled diabetes
* Systemic inflammatory or autoimmune diseases
Improving Work Ability of Young Adults With Stroke

This project will investigate effects of a novel theory-driven 6-week virtual Personal Resource Building and Inclusive Volunteering Intervention (PVI) on young stroke survivors' work ability, self-efficacy and psychosocial outcomes.

It is hypothesised that participants in the intervention group, compared with the control group, will demonstrate the outcomes below at immediately and 3 months post-intervention with respect to baseline: 1) Significant improvement in work ability (primary outcome), 2) Significant improvements in self-efficacy, health-related quality of life (HRQoL), emotional well-being and social skills (secondary outcomes).

Eligible participants will be randomly assigned to receive usual care or PVI with usual care and the control group participants will receive usual stroke care services.

Returning to work is a major rehabilitation priority for young stroke survivors. This project will investigate effects of a novel theory-driven 6-week virtual Personal Resource Building and Inclusive Volunteering Intervention (PVI) on young stroke survivors' work ability, self-efficacy and psychosocial outcomes. A 2-arm, assessor-blind, randomised controlled trial will be conducted. Eligible participants will be randomly assigned to receive usual care or PVI with usual care and the control group participants will receive usual stroke care services. Outcomes including work ability, self-efficacy, health-related quality of life, emotional well-being and social skills will be measured at baseline, immediately post-PVI and 3 months post-PVI.

Eligibility Criteria:
Inclusion Criteria:

* 18-64 years old,
* been clinically diagnosed with a first-ever or recurrent ischaemic or haemorrhagic stroke,
* living at home,
* Montreal Cognitive Assessment score \>2nd percentile,
* a Modified Rankin Scale of 4 or below (moderately severe disability),
* able to communicate in Cantonese and read Traditional Chinese,
* a regular paid employment at the time of stroke,
* been unemployed for at least 3 months at the time of recruitment.

Exclusion Criteria:

* have been diagnosed with transient ischaemic attack,
* have experienced cerebrovascular events due to tumours,
* have been diagnosed with a mental condition such as depression, schizophrenia or bipolar disorder,
* demonstrate incomprehensible speech or difficulty in comprehending conversations, or
* have or are receiving vocational programmes.
Effects of 2 Initial Standard Antiretroviral Combinations Therapies on Lipid Metabolism

This study is an open-label, randomized, pilot comparison of the effects of either lopinavir/ritonavir or efavirenz in combination with tenofovir plus emtricitabine on cholesterol metabolism, mitochondrial functioning and immune response in 50 naive HIV patients after 48 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Chronic HIV-1 infection
* Age 18 or above
* Antiretroviral-naive
* Criteria for antiretroviral therapy in accordance with current guidelines
* Plasma LDL-cholesterol below 190 mg/dL
* Not receiving lipid-lowering agents
* Written informed consent

Exclusion Criteria:

* Use of phytosterol-enriched food previous month.
* Pregnancy or breastfeeding
* Cardiovascular disease
* Secondary Hypercholesterolemia
* Plasma creatinine above 1,2 mg/dL)
* Aminotransferases above 5 times ULN
* Current treatment for hepatitis C coinfection
* Diabetes mellitus (fasting glycemia \> 124 mg/dL)
* Illegal drug use or alcohol abuse
* Active AIDS-defining opportunistic disease