cyrilzakka/clinical-trials huggingface dataset:
Facilitating Neuroplastic Changes of Acute Stroke Survivors

This project will develop a wearable rehabilitation robot suitable for in-bed acute stage rehabilitation. It involves robot-guided motor relearning, passive and active motor-sensory rehabilitation early in the acute stage post-stroke including patients who are paralyzed with no motor output. The early acute stroke rehabilitation device will be evaluated in this clinical trial.

Stroke survivors often experience loss of motor control and impaired function. Immediately after stroke, there is a time-limited window of heightened plasticity during which the greatest gains in recovery occur. Therefore, early intensive sensorimotor rehabilitation post-stroke is critical in improving functional outcomes and minimizing disability. However, acute stroke survivors often receive little active training to improve mobility during their hospital stay and they are left alone during most of the day. Especially for those acute patients with no voluntary motor output, active motor training might be even less, partly due to a lack of rehabilitation protocols to detect potential motor recovering signals sensitively and facilitate neuroplastic changes. To address this unmet clinical need, this project will develop a novel wearable rehabilitation robot suitable for in-bed acute stage rehabilitation with guided motor relearning, passive and active motor-sensory rehabilitation early in the acute stage post-stroke including patients who are paralyzed with no motor output. The early acute stroke rehabilitation device will be evaluated in this clinical trial.

Eligibility Criteria:
Inclusion Criteria:

* Acute first time unilateral hemispheric stroke (hemorrhagic or ischemic stroke, 24 hours after admission to 1 month post-stroke at the start of the proposed treatment)
* Hemiplegia or hemiparesis
* 0≤Manual Muscle Testing (MMT)\<=2
* Age 30-85
* Ankle impairments including stiff calf muscles and/or inadequate dorsiflexion

Exclusion Criteria:

* Medically not stable
* Associated acute medical illness that interferes with ability to training and exercise
* No impairment or very mild ankle impairment of ankle
* Severe cardiovascular problems that interfere with ability to perform moderate movement exercises
* Cognitive impairment or aphasia with inability to follow instructions
* Severe pain in legs
* Severe ankle contracture greater than 15° plantar flexion (when pushing ankle to dorsiflexion)
* Pressure ulcer, recent surgical incision or active skin disease with open wounds present below knee
Implementing an Integrated RMNCH Intervention by Community Health Workers in Achham and Dolakha: National Pilot

The investigators will conduct a cluster-controlled, stepped wedge implementation science trial of a bundled reproductive, maternal, neonatal, and child healthcare (RMNCH) delivery intervention within an approximate population of 300,000 people in rural Nepal. This intervention integrates five evidence-based approaches for reproductive, maternal, newborn, and child health focused on the "golden 1000 days" from conception through age two: 1) Community Health Worker model of home-based care to monitor and increase utilization of services, maternal and neonatal health knowledge, self-efficacy, social support, and emergency planning among mothers; 2) Continuous surveillance of all pregnancies and children via an integrated electronic medical record; 3) Delivering community-based integrated management of newborn and childhood illness (CB-IMNCI) via CHWs; 4) Group antenatal and postnatal care to improve care delivery and reduce mortality during the "golden 1000 days" from conception to age two; and 5) Balanced counseling to increase post-partum contraception.


Eligibility Criteria:
Inclusion Criteria:

1. Reproductive aged women 15-49;
2. Reproductive aged women 15-49; recently delivered in past two years;
3. Reproductive aged women 15-49; active pregnancy during study period and identified by a CHW serving their village
4. Children aged 0-2; children of recently-delivered mothers (population #2 or #3 above);
5. Healthcare staff; CHWs serving village clusters, CHW Leaders serving one of the village clusters, Nyaya Health Nepal and Government of Nepal employees involved in study design, program implementation, data collection, or data analysis processes; and
6. Must reside in either Achham or Dolakha District, Nepal.

Exclusion Criteria:

Patients meeting inclusion criteria and consenting to study enrollment, as stated above, will be included in the study unless 1) patients migrate from the study are before completion of any of the bundled interventions; 2) patients request exclusion from the study at any point during the bundled intervention.
A Study of Subcutaneous Nivolumab Monotherapy With or Without Recombinant Human Hyaluronidase PH20 (rHuPH20)

The purpose of this study is to investigate the effects of nivolumab when given under the skin with or without rHuPH20.

This study will include participants with 1 of the following advanced or metastatic tumors approved for treatment with nivolumab monotherapy:

* non-small cell lung cancer (NSCLC)
* renal cell carcinoma (RCC)
* unresectable or metastatic melanoma
* hepatocellular carcinoma (HCC)
* microsatellite instability-high or mismatch repair deficient colorectal cancer (MSI-H/dMMR CRC)
* in Part B, other solid tumors may be considered at the discretion of the Clinical Trial Physician
* In addition to the above tumors, Part E will also include participants with metastatic urothelial carcinoma (mUC).


Eligibility Criteria:
Inclusion Criteria:

* Histologic or cytologic confirmation of advanced (metastatic and/or unresectable) solid tumors of one of the following tumor types:

  1. Metastatic squamous or non-squamous NSCLC
  2. RCC, advanced or metastatic
  3. Melanoma
  4. HCC
  5. CRC, metastatic (MSI-H or dMMR)
  6. In Part B, other solid tumor types may be considered at the discretion of the Medical Monitor
  7. In Part E, Metastatic urothelial carcinoma
* Measurable disease as per RECIST version 1.1 criteria
* ECOG performance status of 0 or 1

Exclusion Criteria:

* Active brain metastases or leptomeningeal metastases
* Ocular melanoma
* Active, known, or suspected autoimmune disease

Other protocol defined inclusion/exclusion criteria apply
Potential Drug Interaction Between ALXN2040 and Rosuvastatin

This study will assess the potential drug-drug interaction (DDI) between ALXN2040 and rosuvastatin.

This is an open-label, 2-treatment, 2-period, fixed-sequence DDI study in healthy adult participants.

This study will comprise of:

* Screening duration of 27 days.
* Two treatment periods: Approximately 14 days. Treatment Period 1: 6 days Treatment Period 2: 8 days
* Follow-up: 7 (± 2) days following the final dose of study intervention.

There will be a washout period of at least 5 days between the single dose of rosuvastatin in Treatment Period 1 and the first dose of ALXN2040 in Treatment Period 2.

Each participant will be involved in the study for approximately 48 days.

Eligibility Criteria:
Inclusion Criteria:

* Medically healthy participants with no clinically significant or relevant abnormalities as determined by medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory safety evaluation (hematology, biochemistry, coagulation, and urinalysis) that is reasonably likely to interfere with participation in or ability to complete the study, or to potentially confound interpretation of study results, as assessed by the Investigator.
* Body mass index (BMI) within the range 18 to 32 kg/m\^2 (inclusive), with a minimum body weight of 50.0 kg at Screening.

Exclusion Criteria:

* History of any medical or psychiatric condition or disease that, in the opinion of the Investigator, might limit the participant's ability to complete or participate in this clinical study, confound the results of the study, or pose an additional risk to the participant by their participation in the study.
* History of meningococcal infection.
* History of drug or alcohol abuse within 2 years prior to first dose of study intervention, or positive drugs-of-abuse or alcohol screen at Screening or Day -1.
* Current tobacco users or smokers or a positive cotinine test at Screening.
* Any major surgery within 8 weeks of Screening.
* Donation of whole blood from 3 months prior to first dose, or of plasma from 30 days prior to first dose of study intervention.
* History of malignancy within 5 years prior to Screening.
* Evidence of human immunodeficiency virus (HIV) infection (HIV antibody positive) at Screening.
* Evidence of hepatitis B (positive hepatitis B surface antigen or positive core antibody with negative surface antibody) or hepatitis C viral infection (hepatitis C virus antibody positive) at Screening.
* Female participant who is pregnant, breastfeeding, or intending to conceive during the course of the study.
Effect of Dual Task Balance Training on Cognitive Functions in People With Mental Retarded

With this study, it will be tried to determine whether the addition of physiotherapy program to the education of mentally disabled individuals is effective and necessary in terms of mental performance.

Mental disability levels IQ = 50-79 individuals with mild / border mental disabilities will be included in the study. The disability status of the individuals will be determined by the health report, and the cognitive status of the individuals will be determined by the report given as a result of the evaluation made by the Guidance Research Centers of the National Education Directorates. The 45-person study group will be randomized to 3 groups of 15 persons each. The first group will not be subjected to any application except education. The second group will be the control group and will be taken to the balance training in addition to normal education. In the third group, dual task balance training will be applied within the scope of cognitive rehabilitation

Eligibility Criteria:
Inclusion Criteria:

* IQ 50-79
* 6-14 years old
* take command of Turkish
* do not have physical disability
* not have metabolic and systemic disease
* To have a report on the mental disability and education required by the Ministry of National Education

Exclusion Criteria:

* To have any situation that prevents the taking of commands related to the exercise program to be implemented
* To have a chronic systemic disease
* To have an educational diagnosis other than the mental disability
Prague Registry of Electric Cardioversion

This single-center observational registry follows contemporary efficacy and short-term complications of elective electric cardioversion.


Eligibility Criteria:
Inclusion Criteria:

* Consecutive out-patients undergoing electric cardioversion for atrial fibrillation, atrial tachycardia, or typical atrial flutter

Exclusion Criteria:

* Unstable patients with acute conditions requiring unplanned hospitalization
Executive Function Performance in Children Who Stutter

The study aims to asses the executive function in children who stutter for better management of those children

It is a case control study which will be done on 30 child who stutter and 15 normal child as a control group. Executive function testing will be done using computerized program called PEPL . Also, total intelligence quation(IQ) , verbal IQ, non verbal IQ will be assessed in both groups. stuttering severity will be assessed in case group.

Eligibility Criteria:
Inclusion Criteria:

1. Patient and volunteers age between 7 years and 15 years.
2. IQ ≥ 85.

Exclusion Criteria:

* History of secondary stuttering.
* Language impairment and other speech problem.
* Concurrent or history of psychiatric, cognitive, neurological disorders or hearing impairment.
Clinical Characteristics of Allergy, Autoimmune and Rheumatic Diseases: A Ten Year Retrospective Study

The incidence and prevalence of the allergic, autoimmune and rheumatic diseases are different all over the world. The relative impact of gene and environment on diseases can be revealed by studies from different populations. National Health Insurance database in Taiwan provides a wealth of epidemiology study, which can contribute to the understanding of these diseases. However, national health care database did not contain test results and clinical details. The database of the hospital records can provide complimentary clinical details. Via the comparison of databases of the National health Institutes and the investigators hospital, the investigators hope that the characteristics and outcomes of these patients can be better understood.

The incidence and prevalence of the allergic, autoimmune and rheumatic diseases are different all over the world. The relative impact of gene and environment on diseases can be revealed by studies from different populations.

National Health Insurance database in Taiwan provides a wealth of epidemiology study, which can contribute to the understanding of these diseases. However, national health care database did not contain test results and clinical details. The database of the hospital records can provide complimentary clinical details. Via the comparison of databases of the National health Institutes and the investigators hospital, the investigators hope that the characteristics and outcomes of these patients can be better understood.

Briefly, epidemiology of target disease such as age, sex, incidence and prevalence will be derived from national database. Medical source utilization such as medication and surgery related to target diseases is also available in national database, providing material for cost analysis. These data can be compared with hospital database to ensure validity and reliability.

The investigators study is intended to provide epidemiology of target disease and cost analysis. Interaction between diseases will also be explored.

Target diseases Allergic diseases: Asthma(ICD9 493.x),Steven-Johnson syndrome and other erythroderma (ICD9 695.x)

Autoimmune diseases: Thyroid disease (ICD9 246.x), Addison disease (ICD9 255.x), type 1 diabetes mellitus (250.x1)

Rheumatic diseases: gout (ICD9 274.x), SLE (ICD9 710.0 ), RA (ICD9 714.0), AS and spondylitis (ICD9 720.0\&720.x), Psoriasis and psoriatic arthritis (ICD9 696.0), scleroderma (ICD9 710.1), Sjogren's syndrome (ICD9 710.2), dermatomyositis (ICD9 710.3), polymyositis (ICD9 710.4), ANCA vasculitis (WG 446.4, MPA, CSS, PAN ICD9 446.0) or vasculitis 447.6, Behcet's disease(ICD9 136.1), Temporal arteritis(ICD9 446.5), Takayasu arteritis (ICD9 446.7), Henoch-Schonlein purpura (ICD9 287.0)

Eligibility Criteria:
Inclusion Criteria:

* subjects with ICD9 coding fulfilling study subjects
Chronic Rhinosinusitis in a Danish Population: Evaluation of Causes of Disease, Progress and Treatment

Introduction: Chronic Rhinosinusitis (CRS) is defined as inflammation of the nose and the paranasal sinuses. It is a very common disorder increasing in both incidence and prevalence with significant impact on quality of life and substantial health care costs. In this study we evaluate the prevalence of CRS in Denmark and there is a need for consensus about diagnosing this disease. Different questionnaires and different tests used for examination are evaluated together with the patients compliance and days lost through illness.

Methods: As part of Ga2len (Global Asthma and Allergy European Network) a questionnaire on CRS was posted to 5000 residents on Funen. From the completed and returned questionnaires self reported CRS was evaluated. Respondents were invited for clinical examination including spirometry, skin prick test, bloodsample and an ENT examination including nasal endoscopy, acoustic rhinometry, peak nasal inspiratory flow and smell test. Questionnaire on quality of life (EQ-5D) and symptom severity (SNOT-22) was completed. Medical diagnosed CRS was diagnosed according to the definition on CRS stated by EPOS (European Position Paper on Rhinosinusitis and Nasal Polyps 2007). CRS is defined as inflammation in the nose and paranasal sinus and should be characterized by two or more symptoms one of which should be either nasal blockage/obstruction/congestion or nasal discharge, +/- facial pain/pressure, +/- reduction or loss of smell. Endoscopic signs should be present and symptoms must have been present \> 12 weeks. Patients diagnosed with CRS were invited for a 1 year and 2 year follow up where examination and questionnaires were repeated and treatment compliance and days lost through illness were evaluated.


Eligibility Criteria:
Inclusion Criteria:

* residents on Funen aged 18-75 years

Exclusion Criteria:
Safety and Efficacy of Ramipril in the Treatment of Essential Hypertension

The purpose of this study is to assess which drug is more effective of Ramiprin®(ramipril) and Tritace®(ramipril) in the Treatment of Essential Hypertension


Eligibility Criteria:
Inclusion Criteria:

* mild and moderate essential hypertension (90mmHg≤DBP≤110mmHg)

Exclusion Criteria:

* 180mmHg≤SBP
* If differences greater than 20mmHg for SBP and 10mmHg for DBP between both arms are present on 3 consecutive readings
* If differences greater than 20mmHg for SBP and 10mmHg for DBP are present on 3 consecutive readings
* impaired hepatic function
* imapaired renal function
* angioedema
* aortic valvular stenosis or obstrcutive ejection disorder
* primary hyperaldosteronism
* renal transplantation, bilateral renal artery stenosis or unilateral stenosis in a single kidney, hemodialysis
* severe respiratory disease
* congestive heart failure( New York Association functional class Ⅲ or Ⅳ)
* malignant hypertension
* labile angina pectoris or myocardial infarction in the last 3 months before study entry
Aminophylline and Contrast Induced Nephropathy in Acute Myocardial Infarction

The purpose of this study is to determine whether additional therapy with Aminophylline to hydration with sodium bicarbonate and administration of N-acetylcysteine is more effective to prevent contrast induced acute kidney injury in patients undergoing primary coronary intervention for acute ST elevation myocardial infarction.

Due to the clinical relevance of contrast acute kidney injury a large number of prophylactic procedures have been investigated. N-acetylcysteine and hydration with sodium bicarbonate are proved to be protective against contrast acute kidney injury. The adenosine-mediated afferent arteriolar vasoconstriction is a possible pathomechanism of renal impairment by contrast agent. It has been observed that aminophylline/theophylline, competitive adenosine antagonists, improves oxygen delivery to ischemic tissue, diminishes oxidative damage to renal tissue and may also scavenge free radicals.

The purpose of this study was to investigated whether the additional therapy with adenosine antagonist aminophylline reduces the incidence of contrast renal damage in high risk patients who have acute myocardial infarction.

Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients with AMI candidates for primary PCI presenting within 12 h of symptom onset with ST-segment elevation of more than 1 mm in at least two contiguous leads of the electrocardiogram

Exclusion Criteria:

* contrast medium administration within the previous 10 days,
* end-stage renal failure requiring dialysis,
* refusal to give informed consent
Patient Reported Outcomes After Oncoplastic Breast Conserving Surgery

The goal of this study is to assess patient satisfaction after oncoplastic breast conserving surgery. With the help of a breast-questionnaire the patient satisfaction will be assessed before the surgery and 4 weeks, 6 months and 1 year after the operation. The main question it aims to answer are: Does breast conserving surgery improve quality of life.

type of study: cohort study, observational

OCBS = oncoplastic breast conserving surgery BCT = breast conserving therapy DCIS = ductal carcinoma in situ

participant population/health conditions

* Patients with newly diagnosed breast cancer, that can be treated breast conserving
* the participants have to be at least 18 years old

Participants will fill out a questionnaire pre surgery, 4 weeks, 6 months and 1 year after the surgery. The individual questionnaires will be compared.

The management of breast cancer has undergone a significant shift over the last century. The advances in systemic therapy have not only improved the overall prognosis however also allowed for less radical surgery and more breast conservable efforts. The term oncoplastic breast conserving surgery was first coined in the early 90s where breast cancer surgery was performed while incorporating plastic surgical techniques. Therefore, this enabled the preservation of the natural breast shape with good aesthetic outcomes. Over the years oncoplastic breast conserving surgery has become widely accepted and adopted into routine clinical practice by most breast cancer surgeons. The oncological safety surrounding oncoplastic breast conserving surgery have been well established. Rates of positive surgical margins and re-excision rates have been shown to be similar to traditional lumpectomy operations. Complication rates are also comparable and oncoplastic breast conserving surgery does not result in delays in adjuvant treatments. However, many surgeons would concur that the most significant benefit of oncoplastic breast conserving surgery (OBCS) is patient satisfaction and the potential improvement in their quality of life.

Patient reported outcomes (PROMs) allow us to objectively assess patient satisfaction and the impact the intervention has had onto their lives. Incorporating PROMs into daily clinical practice would not only facilitate shared-decision making but also allow us to tailor clinical management to suit individual patient needs. This study however also aims to assess the patient reported outcome after breast surgery and in the follow up time (after radiotherapy, ...).

Eligibility Criteria:
Inclusion Criteria:

* BCT oncoplastic surgery technique
* Women \> 18 years

Exclusion Criteria:

* Previously treated ipsilateral breast cancer or DCIS
* Severe psychological illness by doctors' discretion (as taking part in a study could increase anxiety) or severe dementia, that stops them to consent to the procedure
* Pregnant women
* Distant metastatic disease (M1)