cyrilzakka/clinical-trials huggingface dataset:
Effect of Robotised Gait Training on Dynamic Balance, Symmetry and Push-off in Persons After Stroke

Rehabilitation robotics is increasingly used because it enables the patients to practice a wide array of movements. Dynamic balance training is essential for gait rehabilitation and robotised devices enhance repeatability, objectivity and precision of such training combined with monitoring and recording of kinematic and kinetic data. The aim of the study is to explore the effect of robot-assisted gait training on dynamic balance, symmetry and take-off in patients after stroke. The investigators will conduct a randomised intervention study where one group will receive visual feedback on gait status and the other group will receive kinetically-assisted training using a robotised device in addition to the visual feedback.

Gait training will start 3 weeks after admission to inpatient rehabilitation. It will last for 3 weeks, 5 times per week, 30 minutes per day. The first few sessions with the robotic device will serve to familiarise the patient with the BART device and training conditions. Further details are described in the Arms and Interventions section.

Eligibility Criteria:
Inclusion Criteria:

* Subacute phase after first ischaemic or haemorrhagic stroke (less than 6 months after stroke);
* Limb hemiparesis;
* Ability to walk independently (FAC 6) or with assistance (FAC 5) on flat and uneven surfaces, stairs and slopes;
* Adequate cardiovascular ability (NYHA 1).

Exclusion Criteria:

* Degenerative process or postoperative condition on lower-limb joints that would hinder gait;
* Associated neurological disease;
* Decreased cognitive ability (KPSS \< 25).
Mohawk Culture, Behavior, Toxicant Exposure and Health

This study will determine the pathways between Mohawk cultural identification and specific behaviors related to pollutant exposure, and determine the effects of these factors and the pollutant exposure on physiologically and socially significant outcomes.

Considerable concern now exists over possible effects on human physical and psychological development of endocrine disrupting environmental contaminants such as polychlorinated biphenyls (PCBs). Native American communities are particularly at risk owing to subsistence systems and a cultural ethos involving greater contact with the physical environment. The proposed study follows-up 220 Mohawk adolescents aged 17-21 years, who participated in a previous study when they were 10-16 years old. All adolescents are members of the Mohawk Nation at Akwesasne which is located on the St. Lawrence River and is adjacent to hazardous waste sites where PCBs have contaminated the local ecology. The investigation examines the interrelationship between Mohawk cultural identity, traditional Mohawk customs, behaviors related to toxicant exposure and current toxicant burden. Serum level of PCBs will be assessed by congener specific analysis. The study will determine the relationship of congeners and their hydroxylated metabolites to thyroid function (levels of triiodothyronine, free triiodothyronine, thyroxine, free thyroxine, thyrotropin and anti-thyroid antibodies), and 2) psychosocial outcomes including school behavior and performance, hyperactivity, and adaptation to the community. Data gathered for the past study will be employed to assess variation in metabolism of PCBs, as well as how earlier measures of cognition and hyperactivity relate to 17 year old psychosocial outcomes. Variation in susceptibility to PCB effects will be determined by examining the effects of concurrent toxicant exposure (hexachlorobenzene, Mirex, dichlorodiphenyldichloroethene, lead), diet, and indicators of PCB metabolism, on the focal measures of adult functioning. The proposed study will clarify the causal pathways between culturally identifying behavior, PCB exposure and body burden, thyroid functioning, cognitive functioning, social behavior and school functioning while identifying activities that are important to maintain cultural identify and unrelated to exposure.

Eligibility Criteria:
Participation in previous study of Mohawk adolescent well-being is required for participation in this project.
Follow-up Study of L059 (Levetiracetam) in Epileptic Patients With Partial Onset Seizures by Open Label Method

The safety and efficacy of L059 was evaluated in patients who completed "N165 Clinical Trial of L059". They received L059 at a daily dose from 1,000 mg to 3,000 mg in addition to their standard concomitant AEDs


Eligibility Criteria:
Inclusion Criteria:

* Patients who completed the evaluation period (Week 16) of N165 Clinical Trial of L059
* Patients/the parent or guardian wish to continue treatment with L059 and to enter N165 Follow-up Study, and also the investigator admit the necessity of the repeated intake of the investigational drug for the patients.

Exclusion Criteria:

* Patients who had not participate in N165 Clinical Trial of L059.
* Patients who had participated in N165 Clinical Trial of L059 with no intention of entering the follow-up study taking the same medication.
* Patients had not been in compliance with requirements of Protocol for N165 Clinical Trial of L059 in the course of the study.
Collecting and Storing Blood, Bone Marrow, and Other Samples From Patients With Acute Leukemia, Chronic Leukemia, or Myelodysplastic Syndromes

As one of the nation's largest cooperative cancer treatment groups, the Alliance for Clinical Trials in Oncology (Alliance) is in a unique position to organize a Leukemia Tissue Bank. The member institutions diagnose hundreds of patients with leukemia or myelodysplastic syndrome each year, and uniformly treat these patients with chemotherapy regimens. The Alliance offers centralized data management for the clinical history, the classification of the leukemia and myelodysplastic syndrome, cytogenetics, flow cytometric analysis, treatment and follow-up. The highly skilled health care providers at each member institution are familiar with obtaining informed consent, completing data questionnaires and shipping specimens. There currently exists a central processing facility where samples are prepared for a variety of cellular and molecular studies. Hence, the patient resources, the health care providers, and a processing facility for a Leukemia Tissue Bank are all in place. What is needed, however, and is addressed in the current protocol, is a formal mechanism to procure bone marrow, blood and normal tissue from patients with hematologic malignancies who are to be enrolled on Alliance (Cancer and Leukemia Group B \[CALGB\]) treatment studies.

The objective of the study is to collect and store specimens from every newly diagnosed patient with acute or chronic leukemia or myelodysplastic syndrome (MDS) who are entered on a CALGB protocol for previously untreated patients. Bone marrow aspirate and blood specimens are obtained from patients at diagnosis, remission, or relapse and stored. Buccal smears are obtained at diagnosis, and DNA is extracted and preserved.

It was anticipated that the specimens collected under this protocol would be used by a large number of investigators. This protocol does not describe the details of each approved project (eg, eligibility age range).

Eligibility Criteria:
* Previously untreated patients on a CALGB treatment protocol for leukemia (acute or chronic) or myelodysplasia are eligible. Patients must be registered to CALGB 9665 prior to receiving any therapy for their disease.
* Signed informed consent
Evaluation of CSF-3 in Performing ECG

CSF-3 is a wrist-worn medical device similar to a watch. It is designed to monitor a user's heart rate based on ECG (electrocardiogram) and PPG (Photoplethysmograph) readings, using off-the-shelf ECG and unique PPG chipsets with proprietary algorithms. ECG and PPG are the two primary technologies for measuring heart rate. ECG measures the bio-potential generated by electrical signals that control the expansion and contraction of heart chambers, while PPG uses light-based technology to sense the rate of blood flow as controlled by the heart's pumping action.

The proposed clinical study is a prospective, open, single-center study to evaluate the performance and accuracy of the ECG and heart rate calculation of the CSF-3 investigational Device.

Subjects will be screened by the Principal Investigator. Subjects who meet the study's enrolment criteria will be recruited and fitted with an FDA cleared ECG Holter, and with the investigational Device (CSF-3).

At least 40 eligible subjects will be enrolled in a single center. Data collected from the subjects during the study will be included in the overall performance analysis of the ECG output. Subjects will perform an ECG and CSF-3 Device simultaneously Subjects will remain connected to both the ECG Holter and the CSF-3 Device at the study site for at least 7 minutes duration. The ECG and Holter will be stopped simultaneously. Both recordings data (ECG and CSF-3) will be uploaded and then synchronized offline using a dedicated and validated tool.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 21 years old
* Able and willing to understand and sign the informed consent and follow instructions
* Screening ECG results of Sinus Rhythm
* Wrist size 14 cm (5.5"), Max 20 cm (7.8")

Exclusion Criteria:

* Subjects who are currently enrolled in other clinical investigation
* Subjects diagnosed with a cardiac disorder or any cardiac symptoms
* Subjects with SNR \< 100
* Subjects with ECG quality range \> 1 and \< 30
* Individuals with electrical pacing by a pacemaker
* Subjects who are pregnant or breastfeeding
* Subjects with callous on the index finger or thumb (at fingerprint area)
* Subjects with active wound, prior soft tissue injury or skin conditions at the measurement location Sensitivity to the device material or ECG patches
* Subjects with tremors or otherwise unable to remain still for 15 minutes
* Subjects without two hands and sufficient fingers to complete the study
* Subjects unable to participate based upon investigator discretion
A Study to Learn More About the Safety and the Level of BAY 1747846 in Body Given as Injection Into the Vein at Increasing Single Doses in Japanese Healthy Male Participants

The goal of this clinical study was to learn more about BAY1747846 compared to placebo when given as an injection into the vein in Japanese healthy male participants:

* the safety of BAY1747846 when given at increasing single doses
* the level of BAY1747846 in the body over time when given at increasing single doses.

To answer the first question, the researchers compared the number and severity of medical problems the Japanese participants had after receiving BAY 1747846 at increasing doses and placebo respectively. Doctors keep track of all medical problems that happen in studies, even if they do not think they might be related to the study treatments.

To answer the second question, the researchers determined:

* the (average) total level of BAY1747846 in the body, also called AUC
* the (average) highest level of BAY1747846 in the body, also called Cmax
* how BAY1747846 is removed from the body, also called clearance (CL).


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent prior to any study specific tests or procedures
* Ability and willingness to understand and follow study-related instructions
* Subject is healthy as determined by the investigator
* Japanese male
* Age 20 to 40 years (inclusive) at screening visit
* Body mass index (BMI): 18.0 to 28.0 kg/m\^2(inclusive)
* Body weight: at least 50 kg (inclusive)
* Subjects of reproductive potential must agree to use condoms whenever having sexual intercourse with a woman of child-bearing potential. This applies to the time period from signing of the ICF to at least 1 week after treatment.

Exclusion Criteria:

* Current smoker, or has smoked within 3 months prior to screening Clinical Study Protocol
* Any severe disease within the last 4 weeks prior to administration of study drug
* History of orthostatic hypotension, fainting spells and blackouts
* Any malignant tumor and history thereof
* Any clinically relevant finding at the physical examination
* Any known disposition for allergic, anaphylactoid, hypersensitivity or idiosyncratic reactions, e.g. any history of clinical signs of hypersensitivity reaction to any contrast agent
* Any clinically relevant deviation from reference ranges of the laboratory parameters at screening or alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin exceeding the Upper limit of normal range (ULN) by more than 10%, or creatinine above the ULN, or hemoglobin below 12 g/dL
* Clinically relevant ECG findings, e.g.: Heart rate \<45 or \> 90 beats/min, PR \>220 msec, QTcF \>450 msec, QRS \>120 msec, branch bundle block, any sign of coronary heart disease at screening

  -. Abnormal vital signs, e.g.: Systolic blood pressure \<90 or \>140 mmHg, Diastolic blood pressure \<45 or \>90 mmHg at screening
* Subjects who have participated in a clinical study of an investigational drug within 4 months or an approved drug within 3 months prior to administration of study drug
Natural Virtual Reality in the Application of Hospice Care

In recent years, the use of Virtual Reality devices or somatosensory technology in various fields of teaching or sports has gradually matured. It is even possible to see that libraries or museums use virtual reality to promote reading or art. The trend of cross-border application has been born. The use of horticultural therapy in the current service of dementia or hospice patients is more common than in the past. The research team of the Taiwan Normal University has developed the first 3D Virtual Reality horticultural therapy course in Taiwan. Therefore, this study attempts to use natural virtual reality as an auxiliary care method to see if it can relieve the pain of hospitalized patients in the hospice ward, or relieve the stress of the caregiver (such as the patient's family or ward medical staff)!

The purpose of the study is:

1. Use natural virtual reality as an auxiliary care mode to relieve the painful condition of inpatients in the hospice ward.
2. Use natural virtual reality to relieve the psychological pressure of caregivers (family, medical colleagues).

The subjects of the study were: inpatients in the hospice ward of the hospital, caregivers of inpatients in the hospice ward, and medical staff of the hospice team.

Research methods:

1. Use virtual reality head-mounted equipment to watch the natural landscape for 10 minutes each time. The patient and caregiver watched three times a week during hospitalization. The medical staff watched eight times a day on weekdays.
2. Questionnaire: The patient used the pain scale and the Distress Thermometer (DT) scale as the pre-test questionnaire. The caregiver and the medical staff use the DT scale and the "Profile of Mood States (POMS)" as the pre-test questionnaire.

Expected results: The patient is expected to reduce the pain and enhance the quality of life by viewing the virtual natural landscape. It is expected that caregivers and medical colleagues can relieve stress and enhance the quality of life by watching virtual natural landscapes.


Eligibility Criteria:
Inclusion Criteria:

\*Target: Inpatients in hospice Ward, carers of inpatients in hospice Ward, nurses or physicians of hospice team.

Exclusion Criteria:

* Due to the use of virtual reality headsets, people with eye diseases (glaucoma or cataracts and other people who are sensitive to light) and people with a history of mental illness are excluded.
* Inpatients in the hospice Ward also excluded those with tumors or diseases above the neck, those with symptoms of delirium, confusion, and unconsciousness.
Does Radioiodine Treatment Prevent Atrial Fibrillation and Bone Loss in Endogenous Subclinical Hyperthyroidism?

Subclinical hyperthyroidism is defined as the presence of serum free thyroxine (T4) and triiodothyronine (T3) levels within the reference range and a reduced serum thyrotrophin (TSH) level. Evidence is accumulating that it has important clinical effects. The SUBstudy is a randomised, Dutch multicenter trial to study whether radioiodine treatment prevents the development of atrial fibrillation and prevents decreases in bone mineral density in patients with endogenous subclinical hyperthyroidism.


Eligibility Criteria:
Inclusion Criteria:

* Subclinical hyperthyroidism \[TSH ≤ 0.1 mU/L, fT4 and T3 within the normal range of the own laboratory (determined 2 times in own laboratory) with an interval of at least 2 months\].
* Endogenous cause of subclinical hyperthyroidism limited to autonomous adenoma or multinodular goiter (diagnosis made by the attending physician, based on palpation and the result of a thyroid scintigram).
* Informed consent.

Exclusion Criteria:

* Medication with anti-thyroid drugs in the last 3 months (also not allowed during follow-up); thyroid hormone in the last 3 months (allowed during follow-up, but TSH levels should be kept between 0.1 mU/L and the upper limit of normal in the own laboratory); and oral glucocorticoids in the last 3 months (allowed during follow-up when absolutely necessary, but patients in whom glucocorticoids are started cannot be evaluated with respect to changes in bone mineral density \[BMD\]).
* Radioiodine therapy in the past.
* Iodine-induced subclinical hyperthyroidism.
* Pituitary or hypothalamic insufficiency.
* Pregnancy.
* Age \<= 40 years.
* Severe non-thyroidal illness.
* Drug abuse.
* Unstable angina pectoris, (history of) atrial fibrillation, (history of) congestive heart failure.
* (History of) osteoporotic fracture(s).
* Patients younger than 70 years of age with a bone mineral density T-score \< - 2.5 standard deviations (SD), or older than 70 years of age with a bone mineral density Z-score \< 1.0 SD. (These patients can be randomized but in case it is decided to treat them with anti-osteoporotic drugs they cannot be evaluated with respect to changes in BMD.)
* Use of betablockers in the last three months. (These patients can be randomised but cannot be evaluated with respect to general and cardiac symptoms. The same applies to patients in whom betablockers are started during follow up.)
* Other symptoms or signs of hyperthyroidism or obstruction of vital structures which, in the opinion of the attending physician, require active treatment.
Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial

Evaluate the safety and efficacy of Medtronic Intrepid™ TMVR TF System in patients with moderate-to-severe or severe symptomatic mitral regurgitation, or moderate symptomatic mitral regurgitation combined with mitral stenosis in the presence of MAC who, by agreement of the local site multidisciplinary heart team experienced in mitral valve therapies, are unsuitable for treatment with approved transcatheter repair or surgical mitral valve intervention.

Prospective, single-arm, multi-center, interventional, pre-market trial

Eligibility Criteria:
Inclusion Criteria:

* Subject has moderate-to-severe or severe symptomatic mitral regurgitation as defined by the American Society of Echocardiography 2017 Guidelines and Standards - Recommendations for Non-invasive Evaluation of Native Valvular Regurgitation, or subject has moderate symptomatic mitral regurgitation combined with mitral stenosis with the presence of MAC
* Local site multidisciplinary heart team experienced in mitral valve therapies agrees that patient is unsuitable for treatment with approved transcatheter repair or conventional mitral valve surgery
* Subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits
* Subject meets the legal minimum age to provide informed consent based on local regulatory requirements
* Subjects anatomically suitable for the Medtronic Intrepid™ TMVR TF System

Exclusion Criteria:

* Estimated life expectancy of less than 24 months
* Currently surgically implanted mitral valve
* Prior transcatheter mitral valve procedure with device currently implanted
* Anatomic contraindications
* Anatomically prohibitive mitral annular calcification (MAC)
* Aortic valve disease requiring intervention or previous intervention within 90 days of enrollment
* LVEF \< 25% (measured by resting transthoracic echocardiogram), patients with LVEF 25 - \<30% will be further evaluated by the Screening Committee for approval (Right Ventricular Dysfunction, pulmonary hypertension, and left ventricular function)
* Left ventricular end diastolic diameter (LVEDD) \> 75mm
* Need for emergent or urgent surgery
* Hemodynamic instability
* History of bleeding diathesis or coagulopathy
* End stage renal disease
* Liver failure
* Frailty
Clinical Application of 18F-labeled RD2 PET/CT Imaging in the Diagnosis and Treatment of Small Liver Carcinoma

This is a single arm study to evaluate the safety and biodistribution of 18F-labeled RD2 PET/CT Imaging in patients with small liver carcinoma.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with highly suspected tumor；
2. Patients underwent PET/CT examination within 1 week;
3. Patients voluntarily signed informed consent;
4. Over 18 years old, male or female.

Exclusion Criteria:

1. Pregnant women;
2. Lactating women;
3. Patients with impaired renal function.
In Vitro Human Embryo Culture System

The purpose of this study is to compare the development of human embryos grown in a conventional culture dish to those grown in a new embryo culture device known as the SMART System.

This study is a multi-center, randomized, performance study.

Eligibility Criteria:
Inclusion Criteria - All recruited subjects must meet all of the following inclusion criteria to be enrolled in the study:

1. Female 21 to 35 years of age inclusive
2. First or second IVF cycle
3. Not pregnant
4. No physical abnormalities that would adversely affect oocyte retrieval
5. Male factor is acceptable
6. ICSI is acceptable
7. 10 zygotes or more

Exclusion Criteria- Potential subjects are excluded from the study if any of the following conditions exist:

1. The sperm were retrieved using TESE or MESA
2. The embryos were created with either donor oocytes or donor sperm.
3. Medical condition precluding a safe pregnancy
4. Medical condition disqualifying the subject from safely participating in the study in the judgment of the investigator
Impact of Elastic Band Resistance Training on Female Football Performance: A Pilot Study

The goal of this clinical trial is to assess the effects of a 6-week strength training program with elastic bands on several physical components in adult female football players. The main question it aims to answer is:

Will a specific elastic band resistance training help improve some components of physical performance in adult female football players?

Participants will perform a bi-weekly elastic band resistance training, during a period of 6-weeks. This program will be incorporated into their in-season regimen, before their training session.


Eligibility Criteria:
Inclusion Criteria:

* be over 18 years of age;
* belong in the senior level of an amateur or professional women´s football club;
* play in one of the three Portuguese national women´s football leagues.