cyrilzakka/clinical-trials huggingface dataset:
Screening Study for the Department of Rehabilitation Medicine

The primary function of the Department of Rehabilitation Medicine (RMD) is to diagnose and treat patients at the NIH who have problems in locomotion, activities of daily living, occupational roles, communication, swallowing, or problems with chronic pain. The major goal of this department s to help patients achieve maximal function so that they can resume their daily living activities as normal as possible.

In order for the department to accomplish it's goal it requires the involvement of medical staff and the use of a variety of tests and instruments. Before a new test, evaluation technique, or piece of physical equipment can be considered for use in the treatment of patients it must be carefully studied.

Researchers must make sure the test, technique, or instrument is safe, sensitive, accurate, specific, and reproducible. Therefore all of these tests, techniques, and instruments must first undergo a trial period. Normal volunteers and patients from the RMD and outside of the RMD may be selected to participate in the trial period.

This study provides a framework for researchers in the Department of Rehabilitation Medicine (RMD) to develop new tests, techniques, technology, and equipment.

This protocol provides a framework for clinicians in the Department of Rehabilitation Medicine (RMD) to develop and pilot new tests, techniques, technology, or equipment to remain state-of-the-art.

Eligibility Criteria:
* INCLUSION CRITERIA:

In- and outpatients referred to the Rehabilitation Medicine Department.

Normal volunteers of either sex.
The Prevalence of Chronic Pain and Continued Opioid Use After Cardiac Surgery

The authors propose to evaluate the prevalence of chronic post-operative pain (CPOP) and continued opioid use in the population that has undergone cardiac surgery at the Montreal Heart Institute. In addition, the authors wish to evaluate the presence of known risk factors for CPOP in this population.

This study will use a 15-minute telephone survey to prospectively evaluate the prevalence and intensity of chronic pain 6 months and 1 year after cardiac surgery. Data on the level of post-operative pain experienced on days 1 to 4, at the time of surgery, as well as opioid consumption, adjuvant pain treatments and other variables of interest that are currently recorded prospectively at time of surgery will be culled from patient charts. Additionally, the possibility of continued opioid use by patients at 6 months post-surgery will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

All patients who have surgery at the Montreal Heart Institute between October 1 2017 and October 1 2018 will be eligible for selection.

Exclusion Criteria:

Patients who have declined to be contacted after surgery as noted on the MHI form "Consent for futur projects".

All patients who accepted to be contacted but decline to participate when contacted after their surgery.

Patients who cannot be reached by phone. Patients who cannot speak French
Effects of Walking and Heating on Vascular Function in Diabetic Patients

The purpose of the present study is to determine the effects of increased walking and lower body heating on leg vascular function in patients with type 2 diabetes (T2D).

The notion that habitual aerobic exercise increases insulin-induced vasodilation is largely founded on rodent studies, hence the urgent need for human studies, especially in patients with type 2 diabetes (T2D). For example, it remains unknown if increased walking, the most common form of physical activity, enhances skeletal muscle vasodilator actions of insulin in T2D. In addition, the molecular mechanisms by which exercise improves vasoreactivity to insulin have not been examined in humans. The investigators propose that in T2D patients who are sedentary (i.e., the vast majority), increased leg blood flow with walking or local heating signifies a vital strategy to correct vascular insulin resistance. This study will establish whether increased physical activity and associated hemodynamic forces (e.g., shear stress) are a direct form of vascular medicine in humans.

Eligibility Criteria:
Inclusion Criteria:

Patients with type 2 diabetes who are overweight and obese (BMI 25-50 kg/m2), 35 to 65 years of age, and sedentary (\<60 minutes structured exercise/week). Healthy volunteers without type 2 diabetes: 18 to 65 years of age.

Exclusion Criteria:

1. Cardiovascular disease including myocardial infraction, heart failure, coronary artery disease, stroke;
2. renal or hepatic diseases;
3. active cancer;
4. autoimmune diseases;
5. immunosuppressant therapy;
6. excessive alcohol consumption (\>14 drinks/week for men; \>7 drinks/week for women);
7. current tobacco use;
8. pregnancy;
9. mobility limitations;
10. foot ulcers;
11. diabetic neuropathy
12. uncontrolled hypertension (\>=180 systolic / 100 diastolic mmHg)
A Study of Oral Venetoclax Tablets and Oral Azacitidine as Maintenance Therapy in Adult Participants With Acute Myeloid Leukemia in First Remission After Conventional Chemotherapy

This study will be conducted in two parts. Part 1 will be the Dose Confirmation portion to determine recommended Phase 3 dose (RPTD) of venetoclax in combination with azacitidine (AZA). Part 3 will be the Dose Finding portion to determine RPTD of venetoclax in combination with AZA. Part 2 and Part 3 Randomization of the study were removed.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of newly diagnosed acute myeloid leukemia (AML).
* Participant meets the following disease activity criteria:

  * Confirmation of AML by World Health Organization (WHO) criteria (2016) and have confirmed complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following completion of intensive induction and consolidation chemotherapies.
  * Achieved first CR + CRi within 120 days of first dose of study drug or be no more than 75 days since last dose of intensive conventional (including both induction and consolidation) chemotherapies.
  * AML has intermediate or poor risk cytogenetics per National Comprehensive Cancer Network (NCCN) 2016 criteria.
* Eastern Cooperative Oncology Group (ECOG) performance status \<= 2.
* Participant must have adequate hematologic, renal, and liver function laboratory values as described in the protocol.

Exclusion Criteria:

* History of acute promyelocytic leukemia (APL).
* History of active central nervous system involvement with acute myeloid leukemia (AML).
Rosiglitazone and Exercise Training: Effects on HIV-Infected People With Insulin Resistance, Hypertriglyceridemia, and Adipose Tissue Maldistribution

Several complications have become prevalent in people living with HIV/AIDS, including increased blood sugar, increased blood fats and cholesterol, and fat tissue redistribution. The causes of these complications are not well understood and effective treatments have not been identified. We propose to test the efficacy and safety of 2 treatments for these complications in people living with HIV/AIDS: aerobic, weight lifting exercise training, and a new insulin-sensitizing agent called rosiglitazone (Avandia). Exercise and rosiglitazone have been effective and moderately safe when used in HIV-seronegative people with diabetes, but a specific trial is needed to test efficacy and safety in people living with HIV/AIDS.

We propose a 12wk controlled, randomized trial that compares the effects of rosiglitazone therapy, exercise training and combined rosiglitazone and exercise training. We hypothesize that rosiglitazone will lower blood sugar, insulin, blood fats, muscle and liver lipid content and composition in HIV-infected people. Exercise training will induce the same benefits, but will also reduce abdominal fat mass. We hypothesize that combining exercise training with rosiglitazone therapy will be most effective at reducing blood sugar, insulin, lipids, muscle and liver lipid contents, and restoring body fat distribution than either intervention alone. At baseline and after 12 wk of treatment we will measure: the ability of insulin to promote the clearance of sugar from the blood, the clearance rate of blood sugar, the rate of glucose production by the liver, blood fat and cholesterol concentrations, body fat content and fat distribution in the arms, legs, trunk regions, muscle and liver lipid content and composition.

Eligibility Criteria:
The research volunteers will consist of HIV-infected men and women treated with PI-based HAART who have developed insulin resistance of impaired glucose homeostasis:

* fasting (8h) plasma glucose 110-126 mg/dL (6.1-7.1 mM) OR
* plasma glucose \>140 (7.8 mM) 2 hours after a 75g-oral glucose load.

Although not required for enrollment, many of these volunteers will also have developed trunk adipose tissue redistribution (defined as): trunk/appendicular adipose ratio using whole-body DEXA \>1.1 (men), \>0.9 (women), or visceral adipose/total abdominal adipose tissue (VAT/TAT) \>0.40 using 1H-MRI imaging at the level of the umbilicus (\~L3-L4 inter-vertebral space). Many will also have developed fasting hypertriglyceridemia (\>300mg/dL, \>3.4 mM).

* Plasma viremia (Roche Amplicor assay) \<5000 copies/ml OR a CD4 T-cell county \>= 200 cells/ul for at least 3 months prior to enrollment.
* Stable on a PI-containing HAART regimen for at least 3 months prior to enrollment.
* 18-65 years of age
* Body mass index \<= 34kg/m\*2, total body fat \<=35% of weight
Collection of Blood Samples From SMART Study Participants for Future Genetic Studies

The purpose of this study is to collect blood samples from SMART study participants to use in future genetic studies.

Despite progress in the treatment of HIV and a greater understanding of the pathophysiology of HIV infection, there are still unexplained differences in both the progression of untreated HIV infection and response to antiretroviral therapy. These differences are likely related to the unique genetic makeup of individuals with HIV infection. Particular genes may offer protection against HIV infection, while other genes may make disease progression more likely. Knowing more about the genetic makeup of HIV infected individuals may lead to the development of a targeted treatment strategy based on an individual's specific risk of disease progression and sensitivity to medication toxicity. The purpose of this substudy is to collect blood samples from SMART study participants. The samples will be used in future Community Programs for Clinical Research on AIDS (CPCRA) studies investigating the link between human genetic factors and clinical outcome data.

This study will enroll individuals currently participating in the SMART study. Participants will provide one blood sample. Individual test results from future blood analyses will not be provided to a patient unless they may have profound health implications for that patient.

Eligibility Criteria:
Inclusion Criteria:

* Coenrollment in the SMART study
* Parent or guardian willing to provide informed consent, if applicable
Assessment of the Wound Healing Efficacy and Tolerance of a Medical Device on Wounds in Healthy Subjects.

The tested medical device is indicated for the treatment of wounds and small skin injuries. The intention of this study is to evaluate the tolerance and efficacy of the test product by measuring the recovery of the skin barrier after wound produced by suction blister. But also, by validating the accompanying physiological effect of the study product during this recovery.


Eligibility Criteria:
Inclusion Criteria:

* Subject with a phototype I, II or III according to the Fitzpatrick scale
* Subject aged between 18 and 45 years included at selection visit
* Subject with absence of infectious diseases (HIV and Hepatitis), confirmed by negative blood test results

Exclusion Criteria:

* History of keloids and hypertrophic scars
* Subject with removal of axillary lymph nodes
* Pathology, active skin disease or dermatological condition in progress (psoriasis and/or lichen ruber and/or eczema ...) or presence of dermatological lesions on the inner side of the forearm (solar erythema or dermatosis ...) that may affect the performance of the research or judged incompatible with the realization of the study
* Subject with severe illness (severe infectious disease (e.g. severe flu)), chronic disease or acute evolutionary pathology likely to influence the study results or considered by the investigator hazardous for the subject or incompatible with the study
* Knowledge of Acquired Immunodeficiency Syndrome or Infectious (acute) Hepatitis
* Subject presenting a healing pathology or a pathology with consequences on the healing like the diabetes mellitus (type I and type II)
* Subject with congenital methemoglobinemia or porphyria
Locoregional Blocks for Breast Cancer Surgeries

Breast surgeries are common operative procedures that require appropriate postoperative analgesia.

Numerous pain relief techniques, including several new regional anesthesia techniques, are available for control of acute pain after breast surgery.

Eligibility Criteria:
Inclusion Criteria:

* female cancer breast patient
* age from 18- 65

Exclusion Criteria:

* coagulation defect
* Patient refusal
* abnormal kidney and or liver function tests
Conectar Jugando Online: Board Games to Improve Executive Function in School-age Children (CJ-Online)

Good development of executive functions at school has been related to a better adaptation of children in different areas of their daily life and, especially, with adequate academic performance. Taking into account the importance of play in childhood, some interventions aimed at training these cognitive processes have been based on the use of playful elements, such as modern board games. Although it is still an unexplored field of research, some studies with older elementary school children and with ADHD children have found significant improvements in executive functions after training that had the board game as a key intervention element. However, we still do not have studies that have explored the possible cognitive benefits of its use throughout the primary stage with the general population. For this reason, the main objective of this study is to test the effectiveness of a cognitive training program based on modern board games in primary education children (6 to 12 years old).

As hypotheses, it is established that: i) the experimental group will present a significantly greater improvement in the neuropsychological tasks that measure executive functions and associated cognitive processes compared to the passive control group after the intervention; ii) the experimental group will present a significantly greater improvement in the tests evaluated by their parents after the intervention compared to the passive control group. All hypotheses will be controlled for age, estimate of IQ and socioeconomic status, as well as previous experience in board games and other cognitive activities.

Eligibility Criteria:
Inclusion Criteria:

* be enrolled in a public, private or subsidized ordinary educational center
* provide informed consent from both parents and the participant's agreement to participate in the study

Exclusion Criteria:

* comprehension difficulties due to language reasons
* sensory difficulties that make it impossible to carry out the program activities
* not having the necessary equipment to monitor the sessions online
Group Eczema Education Visits:Impact on Patient and Family Quality of Life

The objective of this study is to determine whether group educational visits improve the quality of life of patients referred to the Dermatology Clinic. Secondary outcomes will be to determine whether group educational visits influences other key elements of patient care such as topical steroid usage, disease exacerbations, emergency visits, and phone calls to the office. Lastly, the investigators hope to evaluate which aspects of the educational visit were found to be the most helpful to families caring for children with atopic dermatitis (AD). Patients will be new atopic dermatitis referrals to OHSU dermatology and pediatric dermatology clinics. All consecutive patients with such appointments during a three month time period will be screened for participation in the study. Parents will be recruited via telephone. In the intervention group, parents will be invited to participate in a group education visit prior to their first appointment with a dermatologist. All parents in the study will fill out questionnaires. The children involved in the study will be assigned an eczema severity score during their routine visits, but this will be incorporated into the regular clinic assessment. The Childhood Atopic Dermatitis Impact Scale (CADIS) assesses the quality of life in households with children who have atopic dermatitis. The Eczema Area and Severity Index (EASI) measures the extent and severity of the patient's atopic dermatitis. The change in CADIS scores will be analyzed to determine if there is a more significant improvement in quality of life for the group in which parents receive the group eczema education visit.


Eligibility Criteria:
Inclusion Criteria:

* Children ages 2 months though 6 years.
* Participants must carry a diagnosis of atopic dermatitis according to the Hanifin and Rajka criteria.
* New patients or consultations at an OHSU clinic.
* English-speaking families will be included in this study

Exclusion Criteria:

* Subjects who have been on systemic therapies for treatment of their atopic dermatitis (prednisone or cyclosporine)
Multinational Study to Evaluate Tadalafil in Asian Men With Signs and Symptoms of Benign Prostatic Hyperplasia

This study is a randomized, double-blind, placebo and tamsulosin-controlled, parallel design, multinational study to evaluate the efficacy and safety of Tadalafil once-a-day dosing for 12 weeks in Asian men with signs and symptoms of benign prostatic hyperplasia (BPH).


Eligibility Criteria:
Inclusion Criteria:

* Asian males, with benign prostatic hyperplasia (BPH) for at least 6 months prior to initiation and IPSS score greater than or equal to 13 at the beginning of the treatment
* Agree not to use any other approved or experimental pharmacologic BPH, erectile dysfunction (ED) and overactive bladder (OAB) treatments at any time during the study.
* Have not taken Finasteride or Dutasteride therapy, Anti-androgenic hormone or any other BPH therapy, ED or OAB therapy for specified duration of time prior to the beginning of the treatment

Exclusion Criteria:

* Prostate specific antigen (PSA) score beyond acceptable range defined for study at initiation
* History of urinary retention or lower urinary tract (bladder) stones within 6 months of initiation
* History of urinary urethral obstruction due to stricture, valves, sclerosis, or tumor at initiation
* Clinical evidence of prostate cancer at initiation
* Clinical evidence of any of the bladder or urinary tract conditions, which may affect lower urinary tract symptom at initiation
* History of cardiac conditions, including Angina requiring certain treatment with nitrates, unstable angina defined for study, positive cardiac stress test before starting the study
* History of significant central nervous system injuries (including stroke or spinal cord injury within 6 months of initiation)
* Use of any nitrates, cancer chemotherapy, androgens, antiandrogens, estrogens, luteinizing hormone-releasing hormone (LHRH)agonists/antagonists, or anabolic steroids at initiation
Efficacy and Safety of Melatonin PR and Clonazepam in Patients With REM Sleep Behavior Disorder in Parkinson Disease

The purpose of this study is to determine whether melatonin prolonged-release (PR) and clonazepam are effective and safe in the treatment of rapid eye movement behavior disorder (RBD) of patients with Parkinson's disease (PD).

RBD is one of the representative non-motor symptoms of PD. Patients with RBD show dream-enacting behaviors such as punching, kicking, singing, screaming, or somnambulism. These can interfere in sleep quality and increase the risk of falling down from the bed and physical injuries of both the patient and sleep partner. Therefore, qualities of life of the patient and sleep partner are negatively influenced by presence of RBD.

Clonazepam has been used for treatment of choice of RBD. However, the efficacy of clonazepam is not proven in the clinical trial. Clonazepam has several side effects that could be problematic in PD patients such as increasing fall-down risk, daytime somnolence, and cognitive decline. Melatonin is a second-line treatment option for RBD, but there has been only one randomized crossover trial that evaluated the efficacy of melatonin on RBD. Finally, there has been no study that evaluate and compare the efficacy and safety of melatonin and clonazepam for treatment of RBD.

Eligibility Criteria:
Inclusion Criteria:

* Subject was enrolled voluntarily and understood the contents of this clinical trial
* Subject was diagnosed as Parkinson disease (PD)
* Hoehn and Yahr (H\&Y) stage 1, 2, or 3
* Existence of caregivers who can provide a information about symptoms of rapid eye movement sleep disorder (RBD) of the participant
* RBD frequency is one or more per week
* Existence of RBD by answering "yes" to the question (RBD-1Q): "Have you ever been told, or suspected yourself, that you seem to 'act out your dreams' while asleep (for example, punching, flailing your arms in the air, making running movements, etc.)?"
* Good compliance for reporting PGI scores and sleep diary

Exclusion Criteria:

* Existence of cognitive decline hard to participate in the clinical trial
* Hypersensitivity to melatonin or clonazepam
* Previous melatonin or clonazepam treatment within 1 month
* Changing anti-parkinsonian medications within 1 month
* Current treatment with sedatives or hypnotics at bedtime
* Diagnosed as epilepsy or current treatment with anti-epileptic drugs
* Severe trauma history due to RBD
* Lactating, pregnant, or possible pregnant
* Subject has confusion or visual hallucination in daytime
* Diagnosed as obstructive sleep apnea or severe snoring
* Diagnosed as other parasomnia
* Presence of severe psychiatric illness
* Alcoholics or drug abuser
* Myasthenia gravis
* Acute narrow-angle glaucoma
* Prior participation to other clinical trials within 3 months
* Presence of severe comorbidities or a cancer
* Existence of illness or problems which makes difficult to be enrolled to this trial judged by clinicians
Characteristics of Hgb C Carriers in Northern Israel and Clinical Features Among Hgb Homozygous

Hgb C is an hemoglobinopathy quite rare in Israel. The clinical status of patients that are diagnosed as homozygous to this disease is quite benign but not study in large groups.

Also the characteristics of carriers and the incidence in northern Israel were a large arab population lives, was not study. The results of this study can be useful for screening purpose in a area were another hemoglobinopathies are frequent.

Hgb C is an hemoglobinopathy quite rare in Israel. The clinical status of patients that are diagnosed as homozygous to this disease is quite benign but not study in large groups.

Also the characteristics of carriers and the incidence in northern Israel were a large arab population lives, was not study. The results of this study can be useful for screening purpose in a area were another hemoglobinopathies are frequent.

The study will record the clinical characteristics of the homozygous Hgb C patients and the hematology characteristics of all the heterozygous carriers detected in northern Israel

Eligibility Criteria:
Inclusion Criteria:

* All patients diagnosed as homozygous for Hgb C disease or double heterozygous in combination to other abnormal hemoglobin, and all the carriers detected in the hematology laboratory during the screening for abnormal hemoglobins in northern Israel