cyrilzakka/clinical-trials huggingface dataset:
Study of the Efficacy, Safety and Tolerability of Low Molecular Weight Heparin vs. Unfractionated Heparin in Stroke

Patients with Atrial fibrillation (AF) make a unique group of ischemic stroke, mostly caused by emboli from the left atrial appendage. Oral anticoagulation (Warfarin) is recommended for prevention of recurrent embolic stroke but it takes several days to reach a therapeutic international normalized ratio (INR : 2.5) so bridging therapy with a short acting intravenous anticoagulant is recommended until therapeutic INR level is reached. A common strategy is to use intravenous unfractionated heparin (UFH) until a standard activated partial thromboplastin time (aPTT) is reached and then initiating warfarin. Another strategy is to use subcutaneous (SQ) injection of a low-molecular-weight heparin (LMWH) eg. Enoxaparin.

The investigators will compare LMWH and UFH, focusing on risk of new stroke and mortality rate.

METHOD: This study is randomized controlled trial that will be performed in 80 patients ages between 18 and 75 with confirmed acute ischemic stroke purely due to AF who will be hospitalized in Shiraz Medical University affiliated teaching hospitals. Patients will be randomly assigned in two groups. A brain CT will be done to confirm the absence of intracranial hemorrhage and to assess the size of cerebral ischemia.

First group will receive 1 mg of enoxaparin (Clexane, Sanofi, Paris) per kilogram of body weight SQ every 12 hour with warfarin 5mg orally everyday and both drugs will be continued until the target INR level (2.5) is reached then clexane will be discontinued.

The second group will receive continuous UFH infusion 1000 unit per hour and then the dose will be adjusted to maintain a therapeutic aPTT (two times to baseline) level then warfarin will be started (5 mg everyday).

The investigators will follow patients in both groups until target INR will be achieved (2.5) and after that clexane and UFH will be discontinued. Adverse events will be assessed in both groups for three months.

Data will be analyzed with Statistical Package for the Social Sciences (SPSS) version 15 and Chi-square statistics.

Main outcome of our study will be evaluation of new stroke, mortality, central nervous system (CNS) hemorrhage, major bleeding, drop out and other unwanted side effects in first week and three months after stroke.


Eligibility Criteria:
Inclusion Criteria:

* confirmed diagnosis of acute ischemic stroke purely due to AF
* AF confirmed by ECG or 24 hour holter monitoring
* patients who need initiation of anticoagulation for prevention of recurrent stroke

Exclusion Criteria:

* ages less than 18 or more than 75
* no cooperation
* CNS hemorrhage
* major bleeding
* infarction size of more than one third of middle cerebral artery territory
* National Institutes of Health Stroke Scale (NIHSS) more than 20
* hypersensitivity to IV UFH or LMWH
* no informed consent
* other causes for stroke except AF
* pregnancy
* breast feeding
* uncontrolled hypertension (BP more than 220/120)
* renal, hepatic, respiratory or cardiac failure
* myocardial infarction
* infectious endocarditis
* coma
* vasculitis
* dissection
Multiple Sessions of Transcranial Direct Current Stimulation in People With Parkinson's Disease

Parkinson's disease (PD) affects approximately 1 million people in the US, with annual health care costs approaching $11 billion. PD results from a loss of dopamine-producing cells in the brain. This decrease in dopamine is associated with shaking, stiffness, slowness, balance/walking problems, thinking, and fatigue which severely impair activities of daily living. Current medical and surgical treatments for PD are either only mildly effective, expensive, or associated with a variety of side-effects. Therefore, the development of practical and effective therapies would have significant benefits.

Transcranial direct current stimulation (tDCS) can influence how the brain works. A review of studies concluded that, overall, tDCS improves walking and balance in people with PD (PwPD). However, these studies had mixed results. For example, most have stimulated the frontal brain areas and all have used intensities of 2 mA (milliamperes; a measure of electrical current strength) or less. However, given the vital role of the cerebellum in walking and balance, and in PD impairments, the cerebellum may represent a more effective brain target. A recent review of studies also recommended performing investigations of higher intensity tDCS (greater than 2 mA), to potentially increase stimulation efficacy. No study has investigated the effects of multiple sessions of cerebellar tDCS on gait and balance in PwPD and none have used tDCS intensities greater than 2 mA. Therefore, there is a critical need to determine if repeated sessions of cerebellar tDCS might improve walking and balance in the short- and long-term.


Eligibility Criteria:
Inclusion Criteria:

To be eligible to participate in this study, people with PD must meet the following criteria:

1. Adult (50-90 yrs) with a positive diagnosis of Parkinson's disease from a movement disorder specialist
2. On an unchanged regimen of dopaminergic medication for at least the last 3 months
3. Able to independently walk for 6 min
4. Without other severe chronic psychiatric or medical conditions
5. Not taking any psychoactive medications

To be eligible to participate in this study, the NH subjects must meet the following criteria:

1. Adult (50-90 yrs)
2. Able to independently walk for 6 min
3. Without any severe chronic psychiatric or medical conditions
4. Not taking any psychoactive medications

Exclusion Criteria:

An individual from either group who meets any of the following criteria will be excluded from participation in this study:

1. Pregnant
2. Known holes or fissures in the skull
3. Metallic objects or implanted devices in the skull/head (e.g., metal plate, deep brain stimulator)
4. Current or previous injuries or surgeries that cause unusual gait
5. A score less than 24 or 17 on the Montreal Cognitive Assessment (MoCA) or telephone-MoCA, respectively

Additional exclusion for PwPD:

1. Experience freezing of gait
2. A diagnosis of dementia or other neurodegenerative diseases

Additional exclusion for NH subjects:

1. A diagnosis of dementia or any neurodegenerative diseases
Families, Responsibility, Education, Support, and Health for Executive Function

The pilot study will be a one group open-label treatment program and will be used to refine a parent-based behavioral treatment enhanced with executive-function training (PBT-EF) for children with comorbid overweight or obesity and Attention-Deficit Hyperactivity Disorder (ADHD).

The currently recommended treatment for children with overweight or obesity (OW/OB), family-based behavioral treatment (FBT), results in sustained weight loss for only 1/3 of children. Attention-Deficit Hyperactivity Disorder (ADHD) is one of the most common neurobehavioral disorders in children and is characterized by difficulties in Executive Function (EF). Substantial research suggests higher rates of OW/OB in children with ADHD; thus, children with OW/OB and ADHD are likely to have greater difficulties with EF and achieving success in FBT. The proposed study aims to develop a parent-based behavioral treatment enhanced with EF training (PBT-EF) to improve treatment outcomes for children with comorbid OW/OB and ADHD. The treatment will be administered to parents in 18 group sessions over 5 months. Parents and children will be assessed at baseline, post-treatment, and 3-month follow-up. Assessments will include body mass index (BMI), assessments of executive function, and behavioral questionnaires. This study could provide a novel model to treat OW/OB in children with ADHD, and could inform clinical decision making regarding obesity treatment.

Eligibility Criteria:
Inclusion Criteria:

* Child with overweight or obesity (85-99.9% BMI for age),
* Child age 8-12,
* Child with a diagnosis of ADHD,
* A parent willing to participate who can read and understand English at a minimum of a fifth-grade level, able to attend treatment sessions remotely via Zoom on video.

Exclusion Criteria:

* Current enrollment in an organized weight control program (parent and child)
* Medication specifically prescribed for weight loss (child)
* Medical or psychiatric condition that may interfere with treatment participation or that may require physician monitoring of diet and/or exercise (e.g., acute suicidality; psychosis; substance use disorder) (parent and child)
* Change in psychotropic medication or other medication that may impact weight or ADHD symptoms during the previous 3 months (child)
Peers and Technology for Adherence, Access, Accountability, and Analytics

The overall objective of this project is to utilize the PRECEDE-PROCEED framework to conduct transdisciplinary, translational implementation research focused on improving medication adherence for hypertension control. The central hypothesis is that peer delivery of medications integrated with HIT (PT4A) will be effective in improving hypertension medication adherence, contributing to improved blood pressure among patients with uncontrolled hypertension in western Kenya. This study record will focus on Sub-Aim 2.2: a pilot of the intervention and a survey questionnaire with patients, peers, and clinical staff to evaluate feasibility. The investigators will evaluate impact on systolic blood pressure, medication adherence, and fidelity of implementation. The investigators will also create a retrospective comparator (control) group of CDM patients, through querying AMRS, matched by sex, age, location and initial blood pressure level. The investigators will then use their recorded blood pressure over a comparable period of up to 1 year and to allow for comparison to the blood pressure changes observed in the patients enrolled in the PT4A program to help understand the magnitude and variance of the intervention effects.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients ≥ 18 years old
* Enrolled in the AMPATH CDM PRogram
* Have uncontrolled hypertension (defined as systolic blood pressures ≥ 140 or diastolic blood pressure ≥ 90)

Exclusion Criteria:

* Acute illness requiring immediate medical attention
* Terminal illness
* Inability to provide informed consent
Randomized Multicenter Study of 5 vs 6 Weekly Fraction of RT in the Treatment of SCC of the Head and Neck

Randomized multicenter study of 5 vs 6 weekly fraction of RT in the treatment of SCC of the head and neck


Eligibility Criteria:
Inclusion Criteria:

* Patients with SCC of the head and neck
Ultrasonographic Evaluation of the Radial and Ulnar Blood Flow After Radial Arterial Cannulation

The aim of this randomized study was to compare the impact of two different radial arterial catheters - 20G and 22G - on the changes of diameter, blood flow and velocity of radial artery and ulnar artery after induction of anesthesia and after cannulation.


Eligibility Criteria:
Inclusion Criteria:

* The patient who are scheduled for elective surgery and need arterial cannulation

Exclusion Criteria:

* Coronary occlusive disease
* Known or suspected upper extremity peripheral arterial disease
* Coagulopathy
* DM with peripheral neuropathy
* Infection at puncture site
Study in COvid-19 Patients With iveRmectin (CORVETTE-01)

Treatment of mild COVID-19 is basically performed at an outpatient clinic, then when the symptom and clinical findings exacerbate to a moderate level, patients are admitted. There is no standard treatment for mild cases. This study will investigate whether ivermectin administration suppresses the replication of SARS-CoV-2 in mild to moderate COVID-19 by investigating the negative rate of SARS-CoV-2 PCR by a randomized controlled trial. Subjects are assigned to two groups, the placebo group, and the ivermectin group. The target number of each treatment arm is 120, a total of 240 cases. A single oral administration of 200 ㎍/kg of ivermectin or an ivermectin-free placebo will be administered on an empty stomach. Time to negativization of SARS-CoV-2 PCR as the primary endpoint with additional efficacy and safety of the process will be investigated.


Eligibility Criteria:
Inclusion Criteria:

1. A person who has been diagnosed with COVID-19 (including asymptomatic) by the COVID-19 PCR test (SARS-CoV-2 nucleic acid detection) within 3 days before the qualification test.
2. A person with oxygen saturation (SpO2) in the room air of 95% or more.
3. A person who are 20 years or older at the time of obtaining consent.
4. A person who weigh 40 kg or more at the time of qualification test.
5. A person who understands the content of this clinical trial and can obtain written consent to participate in the clinical trial.

Exclusion Criteria:

1. A woman who is in lactation period or who may be pregnant, or those who do not agree to prevent pregnancy by medically appropriate means for up to 7 days after study drug administration.

   Medically appropriate contraception means that using a combination of two or more of the following: not having sexual intercourse, taking surgical sterilization such as vasectomy or intrauterine device, taking oral contraceptive, using condom.
2. A person who has severe liver damage (AST or ALT at the time of qualification test is more than 3 times the upper limit of institutional standard and total bilirubin is more than twice the upper limit of institutional standard value), renal disorder (eGFR of eligibility test value 30 mL/min/1.73m2 or less).
3. A person with hypersensitivity to ivermectin.
4. A person with a history of severe drug allergies such as Stevens-Johnson syndrome, toxic epidermal necrolysis.
5. A person who has received the prohibited medication within the past month (within the past 6 months for biologics), or those who need to use the prohibited medication during the clinical trial period.
6. Those who are scheduled to receive SARS-CoV-2 vaccination from the date of consent to the end of the follow-up period.
7. A person who are currently participating in other clinical trials or who have participated in other clinical trials within 30 days before obtaining consent.
8. In addition, a person who is determined to be unsuitable as a subject of this clinical trial by the principal investigator."
Urinary Incontinence and Endocrine Factors. A Part of Lolland-Falster Health Study (LOFUS).

Previous studies have shown an increase in the prevalence of urgency and urgency incontinence in women with diabetes. Regarding the condition urinary stress incontinence, the literature is diverted.

The purpose of the PhD project is investigate the prevalence of urinary incontinence and the association to diabetes and thyroid disease in a mainly rual population in Lolland and Falster. Further to investigate if there is any difference in the bladder function in incontinent women with and without diabetes.

Psychometric validation of the questionnaire used to assess urinary incontinence was also performed.


Eligibility Criteria:
Inclusion Criteria:

* woman
* 18 years or above
* participating i The Lolland-Falster Health Study (NCT02482896)

Exclusion Criteria:

* male
* below 18 years
* non-participating i The Lolland-Falster Health Study
Safety and Pharmacokinetics of Escalating Doses of DNIB0600A in Participants With Non-Small Cell Lung Cancer (NSCLC) and Platinum Resistant Ovarian Cancer

Study DNB4987g is a Phase I, multicenter, open label, dose-escalation study of DNIB0600A administered as a single agent by intravenous (IV) infusion every three weeks (q3w) to participants with non-squamous NSCLC or non-mucinous, platinum-resistant ovarian cancer. The study will be conducted in two cohorts: Dose-escalation cohort and Expansion cohort.


Eligibility Criteria:
Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Histologic documentation of incurable, locally advanced or metastatic disease that has failed prior chemotherapy and for which no standard therapy exists, including the following: non-squamous NSCLC or non-mucinous and platinum-resistant ovarian cancer
* Availability and willingness to provide an adequate archival sample of tumor
* Measurable disease
* For fertile men or women of childbearing potential, documented willingness to use a highly effective means of contraception

Exclusion Criteria:

* Anti-tumor therapy, including chemotherapy, biologic, experimental, or hormonal therapy within 4 weeks prior to study treatment
* Major surgical procedure within 4 weeks prior to study treatment
* Known active bacterial, viral, fungal, mycobacterial, or other infection (including human immunodeficiency virus \[HIV\] and atypical mycobacterial disease, but excluding fungal infections of the nail beds)
* Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis
* Untreated or active central nervous system (CNS) metastases
* Requirement for supplemental oxygen to carry out activities of daily living
* Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the participant at high risk from treatment complications
* Evidence of significant uncontrolled concomitant diseases, such as cardiovascular disease, nervous system, pulmonary, renal, hepatic, endocrine, or gastrointestinal disorders; or a serious non-healing wound or fracture
* For participants in the second NSCLC cohort expansion, not more than two prior regimens in the metastatic setting
* Pregnancy or breast-feeding
Attentional Focus and Prefrontal Cortical Activation

Attention may influence the motor performance and frontal activity. This study will examine the effect of different attentional focus : internal, external and divided attention (dual task) on prefrontal cortical activation (fNIRS) and on gait performance. Thirty young healthy voluntary adults will participate in this study.

The subjects will be guided to walk at a normal pace while maintaining the required attentional focus. They will walk on 30 m five times in each of the four different focus conditions :1) no instructions about the attentional focus 2) internal focus on their feet movements, 3) external focus on two lines drawn on the floor, 4) divided attention (walking while performing an arithmetic task). A fNIRS system will be used for the prefrontal cortex activation evaluation and FeetMe soles for gait analyses.

Eligibility Criteria:
Inclusion Criteria:

* Man or woman
* 18 -30 years old
* Informed consent obtained
* Free from any neurological, cardiologic, rheumatologic disorders.

Exclusion Criteria:

* Assisted walker.
* Disorders affecting gait.
* Concomitant medication likely to interfere with the results.
Kaletra in Combination With Antiretroviral Agents

The purpose of this study is to investigate the tolerability of Kaletra (lopinavir/ritonavir) in combination with new substances such as integrase inhibitors (INIs), C-C chemokine receptor type 5 (CCR5) antagonists, and new non-nucleoside reverse transcriptase inhibitors (NNRTIs), as there are many reasons (intolerability, complex resistant patterns or even personal reasons) which may result in a change from the daily clinical routine and lead to the use of a newly approved antiretroviral agent in combination with Kaletra.

This study was designed as a non-interventional observational study. Kaletra was prescribed in the usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines.

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18years of age
* Written informed consent (authorization to the investigator to use and/or disclose personal and/or health data before entry into the KALETRA® post marketing observational study)
* HIV-1 infection
* Patients treated with KALETRA®, independent from their participation in this study
* Patients treated with novel antiretroviral therapy (for at least 8 weeks according to the study amendment), independent from their participation in this study

Exclusion Criteria:

* Hypersensitivity against Kaletra or other ingredients or INIs or NNRTIs or CCR5 antagonists
* Severe liver insufficiency
* No concommitant astemizole, terfenadine, oral midazolam, triazolam, cisapride, pimozide, amiodarone, ergotamine, dihydroergotamine, ergometrine, methylergometrine, vardenafil and/or St. John's wort
Onset PrevenTIon of Urinary Retention in Orthopaedic Nursing and Rehabilitation

Urinary retention (UR) is a common problem in older people undergoing hip surgery. Untreated UR can lead to bladder distention and a permanent damage of the bladder, which can cause both physical and psychical suffering as well as increased costs for society. Even if national and international practice guidelines are in place for handling UR within the health care system, many fail to comply with them. Compliance to clinical practice guidelines are improved if different professions and managers collaborate as a team. In OPTION (Onset PrevenTIon of urinary retention in Orthopedic Nursing and rehabilitation) the investigators will coach multi-professional local facilitator teams in knowledge translation and implementation of UR practice as well as investigate the effects of such evidence-based practice in orthopedic nursing and rehabilitation.

Implementation of research-based knowledge in evidence-based practice within an organization is complex with several known interacting factors. In a health care system these factors can be the care context, knowledge (innovation) and how the organization facilitates such implementations. The implementation strategy of OPTION utilize established theories of facilitation of knowledge implementation considering evidence and context with focus on leadership. The intervention consists of seminars and systematic support for implementation of UR-guidelines OPTION combine studies of adherence to evidence based practice regarding UR for patients over 65 years old that has undergone hip surgery and the health economic aspects of it. OPTION also contribute with improvements and increased knowledge regarding strategies to implement evidence based health care that can be used in other areas than UR and hip surgeries.


Eligibility Criteria:
Inclusion Criteria: Orthopaedic units in Sweden performing hip surgery. -

Exclusion Criteria: Orthopaedic units in Sweden not performing hip surgery

-
Achieving Rapid, Safe and Sustained Glucose Control in Adolescents With Suboptimally Controlled Type 1 Diabetes Using Advanced Hybrid Closed Loop Systems

The rational of this study is to assess if AHCL systems are able to achieve a better metabolic control (better glucometric data) after 2 weeks, 1 months. 6 months and 1 year after the start, in adolescents in not good glycaemic control.


Eligibility Criteria:
Inclusion Criteria:

* All children met the American Diabetes Association (ADA) criteria for T1D diagnosis with a current HbA1c of ≥8.5%.
* Age range 12-17 yrs old

Exclusion Criteria:

* Patients with a diagnose of genetic form of diabetes will be excluded.