cyrilzakka/clinical-trials huggingface dataset:
To Determine the Therapeutic Effect of the Music Glove and Conventional Hand Exercises to Subacute Stroke Patients

The investigators are trying to determine the therapeutic effect of the music glove and conventional hand exercise program to the subacute stroke patients. All participants will be randomized into two groups: AB and BA. They will all exercise at least 3 times a week for 3 weeks with a minimal 3 hours exercise time per week. Participants will receive the other intervention at 3-month post stroke date. Clinical evaluations will be performed at baseline, post therapy after first intervention, 3-week post intervention follow up, 3-month post stroke, post therapy after second intervention, 3-week post second intervention follow up, and 6-month post stroke follow up visits.


Eligibility Criteria:
Inclusion Criteria:

* History of a single stroke at least 1 week prior to enrollment
* Upper Extremity weakness measured on a standard clinical scale
* No active major psychiatric problems, or neurological/orthopedic problems affecting the stroke affected upper extremity
* No active major neurological disease other than the stroke
* Absence of pain in the affected upper extremity

Exclusion Criteria:

* Severe tone at the affected upper extremity as measured on a standard clinical scale
* Severe aphasia as measured on a standard clinical scale
* Severe reduced level of consciousness
* Severe sensory/proprioception deficit at the affected upper extremity as measured on a standard clinical scale
* Currently pregnant
* Difficulty in understanding or complying with instructions given by the experimenter
* Inability to perform the experimental task that will be studied
* Increased pain with movement of the affected upper extremity
Effect of Different VV ECMO Flows on Lung Perfusion Monitored by EIT

The purpose of this study is to investigate the feasibility of using electric impedance tomography (EIT) to monitor lung perfusion during veno-venous (VV) extracopreal membrane oxygenation (ECMO) support, as well as the effect of different ECMO flows on lung perfusion monitored by EIT.

This is a monocentric obsevensional study that uses EIT to monitor lung perfusion during VV ECMO support and the effect of different ECMO flows on lung perfusion as measured by EIT. Patients on VV ECMO who meet the withdrawal criteria as determined by clinical experts will have their ECMO flow gradually reduced. EIT lung ventilation and perfusion monitoring were performed at various ECMO flows.

Eligibility Criteria:
Inclusion Criteria:

1. Patients aged ≥ 18 and ≤ 70 years；
2. Patients supported with VV ECMO for respiratory failure；
3. Patients are intubated and mechanically ventilated.

Exclusion Criteria:

1. EIT contraindications such as chest wound dressing, pacemaker installation, defibrillator, etc;
2. Patients who did not sign the informed consent form;
3. Pulmonary embolism;
4. Pneumothorax;
5. Medium to plenty of chest water;
6. Atrial fibrillation or other malignant arrhythmia leads to a decrease in cardiac output;
7. Refractory shock;
8. Severe chronic heart and lung disease has existed in the past;
9. BMI\>35 kg/m2;
10. Intra-abdominal pressure \>20mmHg.
A Randomized Controlled Trial of Stress Reduction on Cardiovascular Morbidity and Mortality in African Americans

This randomized controlled clinical trial tests the hypothesis that a selected stress reduction approach, the Transcendental Meditation program will reduce all-cause mortality, myocardial infarction and stroke in African American patients with coronary heart disease. Secondary hypotheses include effects on other cardiovascular clinical events, blood pressure and psychosocial stress.

The overall objective of this randomized controlled trial is to conduct a long-term evaluation of the effects of the Transcendental Meditation (TM) program compared to health education (HE) on secondary prevention of clinical events in African American men and women with coronary artery disease (CAD). Patients (N=201; mean age 59 yrs) were enrolled with documented CAD (i.e., coronary angiogram showing at least one artery with \> 50% stenosis). Patients were pretested at baseline and every 6-12 months for the duration of the study for incidence of clinical events, BP, BMI, medication usage, lifestyle behaviors, psychosocial stress factors and intervention compliance. Subjects were followed for a maximum of 9.2 years (mean 5.4 years). The investigators hypothesize that a selected stress reduction intervention, the TM program compared with a health education control may significantly reduce risk for death, myocardial infarction (MI) and stroke in African American men and women with CHD. If successful, the Transcendental Meditation program may be clinically useful in the secondary prevention of cardiovascular disease in a high-risk population.

Eligibility Criteria:
Inclusion Criteria:

African American men and women with documented coronary heart disease defined a coronary angiogram demonstrating the presence of one more coronary arteries with \> or = 50% stenosis.

Exclusion Criteria:

acute MI, stroke or coronary revascularization within the previous three months; symptomatic heart failure with EF \< 20%; dementia or other cognitive impairment determined clinically; and non-cardiac life threatening illness.

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To Evaluate the Efficacy of Supplementation With L. Reuteri + Vit. D3 in Asthmatic Children

The purpose of this project is to evaluate in a randomized clinical trial, double-blind, controlled, the effects of a dietary supplement containing Lactobacillus reuteri DSM 17938 and vitamin D3 in reducing bronchial inflammation and improve asthma control in patients in children with mild / moderate persistent asthma .

To evaluate if the supplementation for three months with Lactobacillus reuteri DSM 17938 (108 CFU) + Vitamin D3 (400 IU) result in a reduction of the degree of allergic bronchial inflammation, measured with the Fractional exhaled nitric oxide (FeNO) and with a series of markers of bronchial inflammation (measured at 'beginning and at the end of the treatment on exhaled condensate): Interleukin 2(IL-2); Interleukin 4 (IL-4); Interleukin 10(IL-10); Interferon γ (IFN-γ).

Eligibility Criteria:
Inclusion Criteria:

* Patients aged between 6 and 14 years old, of both sexes
* Diagnosis of mild / moderate persistent asthma (GINA step 2/3)
* Allergy mite (Dermatophagoides farinae and pteronyssinus + + + / + + + +)
* Levels of vitamin 25 (OH) D \<30 ng / ml
* Signature of the informed consent of one parent or a legal representative

Exclusion Criteria:

* Cardiovascular disease or systemic
* anatomical abnormalities
* Other respiratory diseases
* Taking probiotics and / or prebiotics in the previous 2 weeks
* Taking vitamin D or systemic corticosteroids within 4 weeks
* Participation in other clinical trials
A Study of Two Different Dose Combinations of Nivolumab in Combination With Ipilimumab in Subjects With Previously Untreated, Unresectable or Metastatic Melanoma

The purpose of this study is to evaluate two different dose combinations of nivolumab and ipilimumab in the treatment of melanoma.


Eligibility Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Subject must have been diagnosed with stage III or/and stage IV histologically confirmed melanoma \[per American Joint Committee on Cancer (AJCC) staging system\] that is unresectable or metastatic
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
* Subject has not been treated by systemic anticancer therapy for unresectable or metastatic melanoma

Exclusion Criteria:

* Subjects with active brain metastases or leptomeningeal metastases
* Subjects with ocular melanoma
* Subjects with active, known or suspected autoimmune disease

Other protocol defined inclusion/exclusion criteria could apply
Compare of Petrolatum Gauze, Allevyn, and New Dressing, Betafoam® in the Management of Split-Thickness Skin Graft Donor Site

This study is a randomized, controlled, multi-centre, open-label, phase IV study.

Total 81 patients will be enrolled in this study. Patients will be randomly assigned to Betafoam®, petrolatum gauze or Allevyn for donor site wounds after skin graft operation.


Eligibility Criteria:
Inclusion Criteria:

1. Patients who is same as or more than 19 years old
2. Patients who will receive elective skin harvest operation
3. Patients who is in lateral thigh or buttock with donor site area from 50 to 150 cm2
4. Female patients who use method of contraception for the study
5. Patients who voluntarily sign the informed consent

Exclusion Criteria:

1. Patients who are pregnant
2. Patients who are known to have allergy to the dressing product including PVPI
3. Known hyperthyroidism or other thyroid dysfunction such as nodular thyroid goiter, endemic goiter and Hashimoto's thyroiditis or patients who receive radioiodine therapy
4. Co-morbidities which may adversely affect wound healing for example a patient with uncontrolled diabetes (HbA1c \> 8%), chronic renal failure, autoimmune disease, or immunocompromised patient
5. Patients who receive anticoagulants, steroids or immunosuppressants
6. Patients who have signs and symptoms of infection on enrollment and adversely affect wound healing
7. Patients who have skin lesion such as Herpes zoster on donor site
8. Burn of \>20% total body surface area
9. If the donor site had been harvested on a previous occasion
10. Patients who is limited cognitive ability
11. Patients who are participating in or will plan to participate in other clinical trials
12. Other various conditions that the investigators judge inappropriate for enrolment
Treatment of Opioid/Heroin Dependence: Comparison of Three Medication Dosing Regimens

Heroin dependence remains a major addiction problem in the United States. The purpose of this study is to determine the effectiveness of levoacetyl methadol (ORLAAM) in treating heroin dependent individuals.

Heroin is a highly addictive drug, and its abuse has both medical and social consequences. ORLAAM is approved to treat both opiate and narcotic dependence. The purpose of this study is to determine the efficacy of ORLAAM in treating heroin dependent individuals. In addition, this study will determine the most effective dosing regimen of ORLAAM.

This study will last 20 weeks. Participants will be randomly assigned to receive one of three dosing conditions: 1) standard fixed dose, 2) dose-by-weight, and 3) dose effect. The dose effect condition will include a dose of ORLAAM dependent on opiate use and withdrawal symptoms associated with opiate use; doses may be adjusted throughout the study. All participants will receive cognitive behavioral therapy throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Current opiate dependence
* Provides acceptable proof of identity
* History of 5 or more years of regular heroin use or dependence
* Reads and writes English

Exclusion Criteria:

* Significant suicidal or homicidal ideation, intent, or plan
* Current AXIS I psychotic, depressive, or anxiety disorder
* Meets DSM-IV criteria for dependence on any drug other than nicotine
* Impending legal complications or incarceration
* On parole or probation that requires reports of drug use or research data
* Currently receiving treatment for opiate dependence
* Currently participating in a 12-step substance detoxification program
* Medical condition that contraindicates administration of ORLAAM
* Plans to leave Houston, Texas within the year following study entry
* Pregnant or breastfeeding
* History of heart problems, including heart arrhythmias
* Requires psychotropic medications (e.g., antidepressants, antipsychotics, anxiolytics)
Measurement of Individual Level of Abortion Stigma Study

This study is a randomized controlled trial designed to measure abortion stigma related to the Pennsylvania Abortion Control Act. Women seeking abortion will be randomized to receive the validated Individual Level Abortion Stigma Scale either before or after consent via the Pennsylvania Abortion Control Act language. The primary outcome will be the stigma scores in the two groups.


Eligibility Criteria:
Inclusion Criteria:

1. Women ≥18 years old
2. Seeking induced abortion for any indication
3. Gestation ≤ 24 weeks
4. Plan for procedural or state consent at current visit
5. Willing and able to consent in English

Exclusion Criteria:

1. Have previously been consented in the current pregnancy using the Pennsylvania Abortion Control Act consent language
2. Have previously had an abortion
GORE® VIABAHN® Endoprosthesis Post-Marketing Surveillance Study

This study will confirm the efficacy and safety in the clinical setting after the launch of the GORE® VIABAHN® stent graft (hereafter referred to as "Viabahn") for the treatment of patients with stenosis or occlusion at the venous anastomosis of synthetic arteriovenous access graft.


Eligibility Criteria:
Inclusion Criteria:

* Participants who developed stenosis or occlusion at the venous anastomosis of synthetic arteriovenous access graft
* Participants who was used to repair vascular access circuits for purposes other than treatment of stenosis or occlusion at the venous anastomosis of synthetic arteriovenous access graft
Sentinel Node in Larynx and Pharynx Cancers

This study explores the feasibility of sentinel lymph node identification in pharynx and larynx cancers using flexible endoscopy-guided tracer injection.

The presence of lymph node metastases has a large impact on prognosis and treatment in head-and neck cancer (HNC) patients and necessitates treatment intensification. However, despite increased spatial resolution of current imaging techniques, around 20% of patients with a pre-operative clinically negative neck will have occult metastases in the neck dissection specimen. It is therefore that, when patients are treated with radiotherapy, the neck is almost always included in the target volume, also when the tumor is clinically staged N0 (elective neck treatment). As a consequence, large tissue volumes must be treated resulting in significant morbidity such as mucositis, dysphagia, xerostomia and on the long term also hypothyroidism and vascular damage.

If the detection of small lymph node metastases can be improved elective neck treatment may be avoided in at least part of the patients resulting in less toxicity and improved quality of life. One promising approach is the sentinel node procedure. Thus far, the sentinel node procedure is not employed in patients with larynx and pharynx cancers that are treated with primary radiotherapy. One reason is that these tumors are not easily accessible for tracer injection and this needs to be done under general anesthesia. However, in the past few years there has been progress with instrumentation via flexible endoscopy. The ENT-department of Radboudumc has developed expertise with endoscopic biopsy taking and even laser surgery of pharynx and larynx cancers.

The purpose of this study is to explore the feasibility of sentinel lymph node identification in pharynx and larynx cancers using flexible endoscopy-guided tracer injection.

Eligibility Criteria:
Inclusion Criteria:

* Male or female aged \>18 years.
* Mucosal tumor of the oropharynx, hypopharynx or larynx.
* Patients planned to undergo biopsy via flexible endoscopy.
* Patients planned to undergo curative radiotherapy with or without concurrent chemotherapy.
* Patient provided written informed consent.

Exclusion Criteria:

* Patients who underwent previous surgery or radiotherapy to the neck.
* Patients with airway obstruction causing stridor.
* Prior allergic reaction to Tc-99m-nanocolloïd.
* Pregnancy.
* Unable to provide informed consent.
Finishing HIV Project

This study aims to learn how to help enable healthy behaviors and lower the risk of HIV among Latinx Men.


Eligibility Criteria:
Inclusion Criteria

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Being 18 to 54 years of age
4. Being a cis-gender male
5. Self-report one or more of the following behaviors and health conditions in the last 6 months which meet the Centers for Disease Control and Prevention (CDC) clinical guidelines for PrEP eligibility

   * Diagnosed with bacterial sexually transmitted infection (e.g., syphilis, gonorrhea, or chlamydia)
   * Sex with a partner who is living with HIV
   * Sex without a condom with two or more partners whose HIV status were unknown
   * Injection drug use and sharing injection equipment
6. Self-reported status as HIV negative
7. Willing to be tested for HIV

Exclusion Criteria

1. Display diminished capacity to consent because of:

   * An inability to provide informed consent (e.g., cognitive impairment)
   * Severe psychiatric symptoms (e.g., mania, psychosis) that impair capacity to provide informed consent, as assessed by interviewers with Collaborative Institutional Training Initiative (CITI) Human Subjects Research and National Institutes of Health (NIH) Good Clinical Practice training
2. \<18 years old or \>54 years old
3. Self-reported living with HIV
4. Reactive HIV test (for "Amigx" seeds or "Yo Quiero" control participants)
5. Refusal of HIV test
6. Identifies as Non-Latinx
7. Individuals enrolled in other PrEP initiation interventions
8. Individuals with an active PrEP prescription in the last 6-months (oral or injectable)
Interaction Between the Vaginal and Seminal Microbiome in Patients With an Altered Vaginal Microbiome Pattern Resistant to Treatment

It,s a retrospective case-control pilot study is to be carried out. Twenty patients will be included in the study for each branch (a total of 60). The study population will be patients whose partners have a diagnosis of an altered vaginal microbiome with (Cases, n = 20) or without (Controls, n = 20) persistence to drug treatment. Since a normal reference seminal microbiome has not been described, we will include a control group that will consist of sperm donors (n = 20) who are considered fertile potential without reproductive problems.

The main objective of the project is to identify the interaction of the vaginal and seminal microbiome patterns in couples in which the vaginal pattern is altered and is persistent to drug treatment.


Eligibility Criteria:
Inclusion Criteria:

* Woman who has an altered vaginal microbiome when the presence of bacteria of the Lactobacillus genus is less than 90% and / or the presence of bacteria that cause bacterial vaginosis (Pj: Gardnerella) or that make embryo implantation difficult in a percentage is determined greater than 5%
* Males will be between 18 and 50 years old
* Signed informed consent accepting their participation in the study.
* Male donors will be between 18 and 35 years old

Exclusion Criteria:

* Men who present with fever
* Men who are under treatment with antibiotics
* Men who have an active sexually transmitted disease
* Men who have a chronic prostatitis or a urinary infection (such as epididymitis or orchitis).
Health Economic Assessment of Tygacil® in the Treatment of Secondary Peritonitis in Intensive Care Units (ICUs)

The main goals of the study are: Assessment of Tygacil's cost-effectiveness; Process cost analysis from a hospital perspective (including length of stay, treatment costs, side effect management costs, costs of monitoring, costs of diagnostic procedures, cost of care (TISS 10 score etc.); Efficacy of Tygacil under usual care conditions (cure rate).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of secondary peritonitis
* Treatment in an ICU
* Patient age \>18 years
The Enriched Environment as an Integrated Tool in the Ward Setting

The goal of this longitudinal interventional study is to integrate the enriched environment (EE) in the context of the Neurology Clinic ward of the General Hospital - University of Padua, by verifying its effectiveness and impact on psychological well-being, functional recovery, activity level, and quality of life in people with stroke.

The EE will be integrated within the shared areas of the Neurology ward and in inpatient rooms, providing materials and aids to encourage physical, cognitive and social activity. The study will recruit for 9 months plus 6 months of follow-up. It will recruited a total of 50 people with stroke (25 for experimental and control group). After providing informed consent, participants will be evaluated on admission, at discharge, at 4 weeks (follow-up phone interview) and at 6 months (telephone interview). Participants will be psuedo randomized, as the ward will be environmentally enriched during consecutive alternating time frames. The instrument used to measure the multidimensional recovery will be the Stroke Impact Scale. Specific secondary outcomes will assessed the recovery in motor, cognitive and communication function, the impact on physical activity, mood, the type of activity of participants exposed to EE and the impact on the ward organization.

Eligibility Criteria:
Inclusion Criteria:

* Ischaemic or haemorrhagic stroke, in any territory, occurring at least 24 hours before enrollment;
* Participant consent to participate in the study;
* Mecial stabilisation.

Exclusion Criteria:

* Uncooperative participant, as assessed by theMontreal Cognitive Assessment scale \< 15
* medically not stabtability and/or reduced level of consciousness and/or psychomotor agitation;
* Lack of trunk control (score \<12 in item 3 of the Trunk Control Test: balance in sitting position) such that it is impossible to maintain a sitting position or a safe posture in a wheelchair;
* Speech evaluation confirming comprehension aphasia hampering understanding of informed consent.
Does Addition of a Vessel Loop in Wound Closure Improve Suture Removal?

This study will investigate whether adding a vessel loop under sutures after elective carpal tunnel release increases patient satisfaction with suture removal.

Surgical wound closure with nonabsorbable stitches necessitates subsequent suture removal, a process that can be uncomfortable for the patient and consume clinic time and resources. Anecdotal evidence suggests that the addition of a vessel loop under the sutures both simplifies suture removal and reduces discomfort. In this study, we propose a prospective, randomized, controlled, superiority trial to assess the impact of a vessel loop wound closure and suture removal for elective carpal tunnel release (CTR). Patients will be prospectively enrolled to one of two groups: closure without a vessel loop or closure with a vessel loop. The primary outcome measure will be patient satisfaction with suture removal. Time for wound closure, time for suture removal, pain with suture removal and other patient reported outcomes will be measured. These data will allow us to determine the benefit of addition of a vessel loop in wound closure.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing elective primary CTR (CPT 64721) at Carilion Clinic for carpal tunnel syndrome (CTS) diagnosed by CTS-6 or electrodiagnostic studies (EDS).

Exclusion Criteria:

* Emergency procedures.
* Revision procedures.
* Bilateral procedures.
* Concomitant procedures.
* Inability to provide informed consent for the study.
* Non-native English speakers.
* Allergy to suture material.
* History of wrist trauma.