cyrilzakka/clinical-trials huggingface dataset:
Examining the Effects of a Job Entry Intervention

The current study will examine the efficacy of a virtual reality (VR) intervention as well as a newly developed Kessler Foundation STRength IDentification and Expression tool (VR-STRIDE) with adolescents diagnosed with autism spectrum disorder.

The current study will examine the efficacy of a virtual reality (VR) intervention entitled "IMPRoving Expression of Skills and Strengths In Interviewing in a Virtual Environment" (IMPRESSIVE) which targets social competency skills needed for successful job interviewing. Specifically, 2 VR tools are utilized in the IMPRESSIVE intervention. The first tool is VR-Job Interview Training, a VR program which offers the opportunity for repeated practice with a virtual human interviewer. Preliminary evidence suggests that the VRprogram is successful in adults with ASD and schizophrenia in improving interview abilities. However, the efficacy of it has not been evaluated in adolescents with ASD. This represents a significant void in our knowledge, as we do not know whether this program is effective for youth. In addition to VR training, a newly developed tool is included in the currently proposed intervention: the Kessler Foundation STRength IDentification and Expression tool (VR-STRIDE). KF-STRIDE is focused on improving the ability to express personal strengths during the job interview, a skill that is not taught with VR training. The proposed IMPRESSIVE intervention, which combines the learning of 2 critical abilities (social skills and strength identification), has never been examined in individuals with ASD. Thus, the current proposal will be the first to examine the efficacy of these 2 combined tools in this at-risk population.

Eligibility Criteria:
Inclusion Criteria:

* Diagnoses of ASD
* or am a typically developing adolescent
* Able to speak and read English fluently

Exclusion Criteria:

* History of stroke, traumatic brain injury, or any other neurological injury or disease
* History of significant psychiatric illness (bipolar, schizophrenia or psychosis)
* Uncontrolled seizures
* Any other unstable medical complications
Experimental Trial of rhIFNα Nasal Drops to Prevent 2019-nCOV in Medical Staff

The investigators plan to carry out an experimental study on the preventive effect of recombinant human interferon alpha nasal drops on the infection of 2019 new coronavirus in medical staff.

The investigators plan to carry out an experimental study enrolling more than 2000 medical staff and divide participants into low-risk group and high-risk group according to whether they can directly exposed to 2019-nCOV infected patients. In the low-risk group, participants will be given recombinant human interferon alpha-1b nasal drops (2-3 drops/nostril/ time, 4 times/ day), and in the high-risk group will be given preventive intervention with interferon nasal drops and thymosin-α (thymosin was injected subcutaneously once / week), and the intervention time is 28 days.

Eligibility Criteria:
Inclusion Criteria:

* Formally serving medical staff in Taihe Hospital;

Exclusion Criteria:

* pregnant women;
* severe chronic diseases who are unable to participate in daily routine work;
* fever (temperature≥37.3 ° ) and / or respiratory symptoms.
All-Trans Retinoic Acid (ATRA) Combining Dexamethasone Versus High-dose Dexamethasone for Initial Treatment of Primary Immune Thrombocytopenia (ITP)

The project was undertaking by Qilu Hospital of Shandong University in China. In order to report the efficacy and safety of All-Trans Retinoic Acid (ATRA) combining with High-dose Dexamethasone for the treatment of adults with primary immune thrombocytopenia (ITP), compared to conventional high-dose dexamethasone therapy.

The investigators are undertaking a parallel group, randomised controlled trial of 80 primary ITP adult patients from Qilu Hospital of Shandong University in China. One part of the participants are randomly selected to receive All-Trans Retinoic Acid(10mg tablet by mouth every 8 hours a day for 12 consecutive weeks, combining with dexamethasone (given orally at a dose of 40 mg per day for 4 days, the others are selected to receive high-dose of dexamethasone treatment (given orally at a dose of 40 mg daily for 4 days). Patients were monitored every 1 to 3 days at the first two weeks and every 1 to 4 weeks afterwards for platelet counts, and were monitored every 1 month for transaminitis and other side effects

Eligibility Criteria:
Inclusion Criteria:

1. Meet the diagnostic criteria for immune thrombocytopenia.
2. Untreated hospitalized patients, may be male or female, between the ages of 18 \~ 80 years.
3. To show a platelet count \< 30×10\^9/L, and with bleeding manifestations.
4. Eastern Cooperative Oncology Group（ECOG）performance status ≤ 2.
5. Willing and able to sign written informed consent

Exclusion Criteria:

1. Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 3 months before the screening visit.
2. Received high-dose steroids or \[2\] intravenous immunoglobulin transfusion(IVIG)in the 3 weeks prior to the start of the study.
3. Current HIV infection or hepatitis B virus or hepatitis C virus infections. Severe medical condition (lung, hepatic or renal disorder) other than ITP. 4.Unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia)

5.Female patients who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period.

6.Have a known diagnosis of other autoimmune diseases, established in the medical history and laboratory findings with positive results for the determination of antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct Coombs test.

7.Patients who are deemed unsuitable for the study by the investigator.
Phendimetrazine and Cocaine

This study will determine the safety and tolerability of phendimetrazine (Bontril®) as a pharmacotherapy for cocaine use disorder. A rigorous, inpatient human laboratory study will be conducted in which the subjective and physiological effects of cocaine are evaluated during maintenance on placebo and phendimetrazine.


Eligibility Criteria:
Inclusion Criteria:

* Recent cocaine use

Exclusion Criteria:

* Abnormal screening outcome (e.g., ECG, blood chemistry result) that study physicians deem clinically significant
* Current or past histories of substance abuse or dependence that are deemed by the study physicians to interfere with study completion
* History of serious physical disease, current physical disease, impaired cardiovascular functioning, chronic obstructive pulmonary disease, history of seizure or current or past histories of serious psychiatric disorder that in the opinion of the study physician would interfere with study participation will be excluded from participation
* Females not currently using effective birth control
* Contraindications to cocaine or phendimetrazine
Nasal EPAP for Stroke Patients With Sleep Apnea: a Pilot Trial.

Specific aim: To test the effects of nasal expiratory positive airway pressure (EPAP) therapy on sleep apnea severity among patients with recent ischemic stroke.

Hypothesis 1: Ischemic stroke patients with sleep apnea will have less severe sleep apnea, as measured by the apnea-hypopnea index (AHI), with nasal EPAP therapy compared with a control night.

Hypothesis 2: Ischemic stroke patients will have higher mean levels of oxygen saturation with nasal EPAP therapy compared with a control night.


Eligibility Criteria:
Inclusion Criteria:

* adults with an ischemic stroke (including TIA with infarction) within the prior 14 days

Exclusion Criteria:

1. Current use of any transnasal tube (eg dobhoff tube)
2. Current use of CPAP, mechanical ventilation, or supplemental oxygen
3. Known severe breathing disorders including hypercapnic respiratory failure, respiratory muscle weakness, bullous lung disease, bypassed upper airway, pneumothorax, pneumomediastinum
4. Severe heart disease (including severe heart failure)
5. Pathologically low blood pressure
6. An acute upper respiratory (including nasal, sinus or middle ear) inflammation or infection, or perforation of the ear drum
7. Sores, abrasions, or skin or mucosal irritation on or around the nose.
8. Known pregnancy
9. Inability to provide informed consent
10. Use of alpha blockers or short acting nitrates
11. Permanent pacemaker
12. Sustained non-sinus cardiac arrhythmia
Instrument-assisted Soft Tissue Mobilization and Kinesiotape Application in Individuals With Chronic Neck Pain.

Chronic neck pain causes errors in joint position sense. There are studies in the literature suggesting that instrument-assisted soft tissue mobilization and Kinesiotape applications improve the joint position sense. There is no study examining these applications acutely on joint position sense and pain in the cervical region. As a result of our study, we will compare the effects of single-session instrument-assisted soft tissue mobilization and Kinesiotape application on pain and joint position sense.

The study will be carried out on volunteers after the approval of the ethics committee. Before the research, individuals and / or their relatives will be informed about the purpose and content of the study. Volunteer individuals between the ages of 18-45 with chronic neck pain will be included in the study after obtaining their informed consent.

Participants will be randomly divided into two groups: Instrument assisted soft tissue mobilization and Kinesiotape Applications.

In the instrument-assisted soft tissue mobilization group, the trapezius and sternocleidomastoideus muscles will be applied in a single session for 90 seconds. Kinesiotape application will be applied to the trapezius and sternocleidomastoideus muscles in one session.

Pain will be evaluated with Visual Analog Scale and joint position sense will be evaluated with Cervical Range of Motion device before and after application.

Eligibility Criteria:
Inclusion Criteria:

* Being diagnosed with chronic neck pain
* Being in the age range of 18-45

Exclusion Criteria:

* Those with acute injury or infection,
* Those with open wounds,
* Osteoporosis,
* Hematoma,
* Those with acute cardiac, liver and kidney problems,
* Those with connective tissue disease, Rheumatoid arthritis, osteoarthritis, Cancer,
* Those with circulation problems,
* Those with peripheral vascular disease,
* Epilepsy
* Identified as a history of surgery in the cervical region
5-day Defibrotide Treatment for Hepatic SOS/VOD

Sinusoidal Obstruction Syndrome (SOS), also referred to as hepatic veno-occlusive disease (VOD), is rare but serious complication of allogeneic stem cell transplantation (allo-SCT). Defibrotide is the only FDA approved therapy to treat SOS and has significantly improved outcomes. When applied early, SOS symptoms often quickly improve and an abbreviated course can be applied. This study is looking at an abbreviated 5 day course of defibrotide in those patients with a complete response to therapy with the primary outcome being day 100 overall survival as compared to history data.

Sinusoidal obstructive syndrome (SOS) has a reported mean incidence of 13.7% and even among those undergoing reduced intensity conditioning regimens is approximately 9%. SOS is a clinical syndrome characterized by painful hepatomegaly, jaundice, ascites, fluid retention, and weight gain. The onset is usually before day 35 after stem cell infusion. SOS ranges in severity from a mild reversible disease to a severe syndrome associated with multiorgan failure (MOF) and death. Prior to the introduction of defibrotide, severe SOS was nearly universally fatal with a mortality rate approaching 100% by day 100 after allo-SCT.

The diagnosis of SOS/VOD is clinical and should be considered in any patient who has undergone hematopoietic stem cell transplantation and develops liver dysfunction. Patients with mild or moderate disease have reasonably good outcomes with supportive therapy alone while in contrast prognosis is much worse in severe SOS which occurs in about 25-30% cases.

Defibrotide is the only established Food and Drug Administration (FDA) approved therapy to treat SOS. It is now approved for use in adults and children with SOS with renal or pulmonary dysfunction following HCT. The standard treatment is 25 mg/kg/day in 4 divided doses of 6.25 mg/kg for 21 days. However, responses are frequently brisk and complete in many patients thus it has been postulated that in responding patients this treatment course could be abbreviated given the risk for adverse events such as hypotension/shock and hemorrhage.

This is an open label pilot study evaluating an abbreviated 5 (as compared to 21) day course of defibrotide in patients with confirmed SOS. The primary outcome is day 100 survival as compared to historical data.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who underwent allogeneic stem cell transplantation
2. Age \>/= 18 years
3. Diagnosed hepatic SOS/VOD either by Baltimore Criteria or Modified Seattle Criteria including up to 60 days post-transplantation.

Exclusion Criteria:

1. Significant uncontrolled bleeding
2. Prior or concurrent systemic t-PA
3. Concomitant use of therapeutic heparin or other anticoagulants (except use of heparin for central access patency)
4. Hemodynamic instability (\>1 pressor gent to maintain blood pressure)
Effects of Applying Streaming Media on Reducing Pain in Patient With Second-degree Burn During Changing Dressing

During the acute phase of burn injuries, the focus for patients is primarily on wound pain and infection care. Patients often describe the pain during dressing changes as a sharp, stabbing sensation. Pain is a distressing experience for burn injury patients, affecting both their physical and mental well-being, as well as influencing wound healing. The pain caused by dressing changes is a significant issue that leads to physical and emotional suffering for patients.

Background: During the acute phase of burn injuries, the focus for patients is primarily on wound pain and infection care. In this stage of treatment, frequent dressing changes are necessary, with some wounds requiring daily cleansing to promote healing and prevent infection. Patients often describe the pain during dressing changes as a sharp, stabbing sensation. Pain is a distressing experience for burn injury patients, affecting both their physical and mental well-being, as well as influencing wound healing. The pain caused by dressing changes is a significant issue that leads to physical and emotional suffering for patients.

Objective: The aim of this study is to conduct a cross-over randomized clinical trial to compare the effects of with using streaming media (video and audio) on reducing pain medication use, anxiety, pain intensity, and factors related to pain during dressing changes for second-degree burn patients.

Methods: This study plans to utilize a cross-over randomized clinical trial design with patients from the burn injury ward of a regional teaching hospital in Chiayi. Research instruments include demographic characteristics, disease information, Burn Pain Anxiety Scale, Numerical Pain Scale, and vital signs. Statistical methods will encompass descriptive statistics, independent samples t-test, chi-square test, generalized estimating equations, and multiple linear regression to identify the effectiveness of streaming media usage during dressing changes for second-degree burn patients in reducing pain medication use and anxiety, as well as related factors.

Expected outcomes: It is anticipated that the use of streaming media during dressing changes for second-degree burn patients will lead to reduced pain medication use, anxiety, and related factors. The results of this study can provide evidence for the intervention of using streaming media to alleviate dressing change pain effectively during the care of second-degree burn patients, thereby enhancing the quality of pain care.

Eligibility Criteria:
Inclusion Criteria:

* Must stay in the burn ward for 2 days
* Have clear consciousness
* Aged 20 years old (inclusive) and above superior
* Patients with superficial 2 degree burns accounting for 10% of the body surface area or deep 2 degree burns accounting for 5% of the body surface area were diagnosed by physicians
* Can communicate in Chinese and Taiwanese and agree to participate in this study

Exclusion Criteria:

* Mental disease.
* Cognitive impairment.
* Visual and hearing impairment.
Differential Diagnosis Athlete's Heart From Cardiomyopathy

Assess the effects of strength sport to heart structure and function by T1 mapping with cardiac resonance imaging.


Eligibility Criteria:
Inclusion Criteria:

* Same exercise

Exclusion Criteria:

* Intolerance test
Lidocaine Irrigation in Shoulder Arthroscopy

Arthroscopic shoulder surgery is often associated with severe postoperative pain that is often significant enough to interfere with initial recovery and rehabilitation. The pain that can be difficult to manage without large dose of opioid.

The study aim to explore the effect of continuous irrigation of fluids mixed with lidocaine and epinephrine for analgesic consumption and postoperative pain after shoulder arthroscopy.


Eligibility Criteria:
Inclusion Criteria:

* Age 20-60
* Both genders
* Shoulder arthroscopy
* ASA I-III

Exclusion Criteria:

* Drug allergy
* Psychiatric disorder
* Opioid dependence
* Liver disease
* Patient refuse
HIFT for People With Mobility-Related Disabilities

Investigators will examine the feasibility and health outcomes following a high-intensity functional training intervention for people with mobility-related disabilities. In addition to participant recruitment, attritions rates, and satisfaction, investigators will assess changes to both physical health outcomes (e.g., strength, body composition) and psychosocial outcomes (e.g., quality of life). The findings will provide evidence for the efficacy of HIFT to improve various health outcomes for a population that experiences health disparities in access to, and engagement in, community-based exercise.

The proposed study will examine the feasibility and effectiveness of a high intensity functional training (HIFT) pilot study for adults with mobility-related disabilities (MRD).

Aim 1 will explore the feasibility of a 12-week, thrice weekly HIFT intervention for adults with MRD. Investigators will evaluate participant acceptability and satisfaction, document recruitment challenges, attrition rates, and the adaptive elements of the program for replication and improvement to future clinical trials. Aim 2 will assess the effects of HIFT participation on participant health outcomes, including (i) fitness factors such as work capacity, strength, and energy expenditure; (ii) functional performance; (iii) body composition and weight; and (iv) variables contributing to psychological well-being such as motivation, quality of life, and life satisfaction.

A relatively novel mode of exercise, HIFT stands out for its inclusive approach and adaptable programming, which has the potential to improve health outcomes for a novel target population. The proposed research activities will provide initial data on the feasibility and expected magnitude of change in multiple dimensions of health for people with MRD and contribute to the limited evidence of community-based programs that are adaptable and inclusive. The findings will also allow for the mobilization of this knowledge into disability and healthcare communities to increase the recommendations for exercise for this population and inform future design of clinical trials.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age and older
* have a permanent disability that affects mobility (1 year +);
* Never been a part of a functional fitness program before
* no significant health impairment that would contraindicate exercise (physician clearance required)
* serve as their own guardian

Exclusion Criteria:

* younger than 18 years of age
* have a disability that was acquired within 1 year of starting the study or has a non-permanent mobility limitation (e.g., broken arm);
* has previously been involved in functional fitness
* unable to obtain physician clearance
* Are not their own guardian
Whey Protein Ingestion and Glucose Control in Pre- and Post Diabetic Individuals

To examine the effects of twice daily whey protein consumption on blood glucose and insulin in pre-diabetic and diabetic individuals

Protein consumption in the morning has been shown to reduce appetite and caloric intake (19). In addition, premeal whey consumption reduces post prandial blood glucose, reduces gastric emptying rate, and increases peak blood insulin (10). Thus, it is proposed that ingestion of whey protein within 1hr of waking (and prior to breakfast) and 30 minutes prior to dinner will be more effective in suppressing appetite, carbohydrate intake, and glucose AUC. Ingestion upon waking will mitigate the cortisol-induced drive for carbohydrate intake. Ingestion prior to dinner, the most frequently consumed and largest meal in America (20), will reduce food intake, post meal blood glucose, and insulin area under the curve (21).

Specific Aims

1. Determine the effect of WP ingestion within 1hr of waking and prior to breakfast, and 30min prior to dinner, on appetite suppression, carbohydrate and caloric intake, and 24hr glucose AUC over 7d in pre-diabetic (A1C 5.7%-6.4%) and diabetic (A1C 6.5%-7.5%) individuals.
2. Determine the effect of WP ingestion within 1hr of waking and 30min prior to dinner on changes in OGTT, Matsuda index, and whole-body protein balance (compared to control) before and after 7d of WP consumption in pre-diabetic and diabetic individuals.
3. Determine outcome differences between pre-diabetic and diabetic individuals.

Eligibility Criteria:
Inclusion Criteria:

1. Males and females ages 50-70 years.
2. Capable of providing informed consent.
3. COVID-19 negative and/or asymptomatic.
4. Willing to abstain from drinking alcohol or consuming marijuana and CBD products during the 7-day study meal period on two occasions.
5. HbA1c: 5.7-6.4% or 6.5% to 7.5%

Exclusion Criteria:

1. Subject who does not/will not eat dairy protein sources.
2. Subjects taking exogenous insulin injections or GLP /GIP injections or other appetite suppressants.
3. Unwilling to keep a detailed 7 day food journal on two occasions
4. Unwilling to wear a CGM for 7 days on two occasions and share the data with the research team.
5. Lactose intolerance.
6. Hemoglobin \<10g/dL at screening.
7. History of chemotherapy or radiation therapy for cancer in the 6 months prior to enrollment.
8. History of gastrointestinal bypass/reduction surgery.
9. Pregnant or lactating individuals.
10. History of a chronic inflammatory disease (e.g. Lupus, Crohn's disease)
11. Currently receiving androgen (e.g., testosterone) or anabolic (e.g., GH, IGF-I) therapy.
12. Currently using corticosteroid medications (cortisone, hydrocortisone, prednisone, etc.).
13. Unwilling to avoid using protein or amino-acid supplements during participation.
14. Unwilling to fast overnight.
15. Any medical condition or medication that the PI or clinical study staff finds contradictory to this study.