cyrilzakka/clinical-trials huggingface dataset:
Resistance Training in HFpEF

The objective of this proposal is to determine the effect of resistance exercise training on locomotor muscle function, exercise capacity, exertional symptoms, and quality of life in HF patients with preserved ejection fraction (HFpEF).

In this randomized controlled pilot study of resistance exercise training in patients with HFpEF, the investigators will recruit 24 HFpEF patients who will be randomized to resistance exercise training (RT - n=12) or no resistance exercise training (standard care control group \[CTL\] - n=12). The investigators will have baseline and follow-up measures of clinical characteristics, leg muscle strength, quality of life, lean muscle mass (body composition via DXA including segmental lean mass), maximal cardiopulmonary exercise test (peak VO2, peak work, ventilatory efficiency), constant-load submaximal cardiopulmonary exercise test with speckle tracking echocardiography (exertional dyspnea and fatigue at matched workloads, cardiac output, diastolic function, left ventricular strain, ventilation, gas exchange, and locomotor muscle neural feedback).

Participants will be asked to make 4 separate study visits. Those randomized to undergo Resistance Training will be expected to make those visits as well.

Eligibility Criteria:
All patients will be managed by their primary care physician or cardiologist with additional review and oversight by Dr. Borlaug (Co-Investigator) prior to enrollment to ensure adequacy of inclusion and exclusion criteria and that participation in exercise testing and resistance exercise training is safe.

Inclusion Criteria, includes:

* Clinical diagnosis of HFpEF.
* Patients 18-80 yrs old with a history stable (no medication changes in past 6 weeks (w/duration of diagnosis \>6 months).
* New York Heart Association class I-III.
* Ejection fraction ≥40%.
* Current non-smokers with \<15 pack year history.
* Non-pregnant women, and individuals who are able to exercise (i.e. without orthopedic limitations or neuromuscular disorders).

Exclusion Criteria, includes:

* Patient refusal to participate.
* Significant orthopedic or neuromuscular limitations
* Significant cognitive impairment
* Hemoglobin \< 7.0 g/d.
Optimizing Kidney Transplant Informed Consent

The objective of this study is to evaluate kidney transplant candidates' comprehension about increased risk donor kidneys necessary for informed consent. We have developed a web-based tool that educates and assesses candidates' comprehension (Inform Me), as a supplement to current informed consent processes. We will then compare the effectiveness of the current informed consent processes supplemented by Inform Me, with the current consent processes alone for kidney transplant.

The shortage of kidneys for kidney transplantation results in almost 10,000 deaths per year in the United States. One strategy to increase the number of available kidneys is to offer kidney transplant candidates kidneys that come from donors who have an increased risk of transmission of human immunodeficiency virus (HIV), Hepatitis B and Hepatitis C. Increased risk kidney donors are defined as those who have engaged in behaviors associated with an increased risk of HIV, Hepatitis B, and Hepatitis C, and comprise approximately 9% of all US deceased organ donors. The Organ Procurement and Transplantation Network policy mandated informed consent from recipients who accept increased risk kidneys. The objective of this study is to increase study participants' comprehension about increased risk donor kidneys necessary for informed consent. To accomplish this objective, we will develop a web-based tool that educates and assesses participants' comprehension (Inform Me), as a supplement to current informed consent processes. We will then compare the effectiveness of the current informed consent processes supplemented by Inform Me, with the current consent processes alone. The tool will utilize health information technology to deliver information about the definition of, risks, benefits, and alternatives to using increased risk donor kidneys via a web-based application. Computer adaptive learning will personalize information presented to each candidate according to his/her comprehension levels in interactive chapters to increase comprehension. Inform Me will facilitate nurses' primary role as patient educators.

Eligibility Criteria:
Inclusion Criteria:

* English-speaking
* 21 years or older
* Kidney Transplant candidates eligible: 1) completed the first phase of transplant evaluation education, and 2) wait-listed patients expected to receive a transplant within the next 6 months, returning for re-evaluation.

Exclusion Criteria:

* No special classes of study participants, including fetuses, neonates, prisoners, institutionalized individuals, or other vulnerable populations will be included in the proposed study. Although pregnant women will be eligible for participation in the study, they are unlikely to be selected for kidney transplantation.
The Alama Project: Autism Outcomes and Neurobehavioral Markers in Young Children Born to Mothers With HIV in Kenya

The study will use a non-invasive remote eye-tracking system (Eyelink Portable Duo) to acquire a short series of eye-tracking measures to determine whether these can predict autism diagnoses in both children exposed to HIV and uninfected (CHEU) and children not exposed to HIV and uninfected (CHUU).

The study will use a non-invasive remote eye-tracking system (Eyelink Portable Duo) to acquire a short series (less than 15 mins) of eye-tracking measures (e.g., looking time, pupil diameter, oculomotor dynamics), which may be associated with autism outcomes. Investigators will recruit children enrolled in the Tabiri study during or following their 24-month visit.

The Tabiri study is comparing neurodevelopmental (ND) outcomes between 24-month-old CHEU and CHUU.

Eligibility Criteria:
Inclusion Criteria:

* Children enrolled in the Tabiri study (R01HD104552)
* CHEU or CHUU
* Children ages 24-72 months
* Caregivers of children must speak Kiswahili (local language) or English.

Exclusion Criteria:

* There will be no specific exclusion criteria. We anticipate that a small number of CHEU and CHUU will develop HIV prior to enrollment in the current study; these children will be included and will follow all general study procedures.
Energy Balance for Prostate Cancer Survivorship

The purpose of this study is to evaluate the effectiveness of a weight management program for men undergoing a prostatectomy by seeing if the program is easy to follow, impacts weight gain, and reduces risk of cancer recurrence in the participants.

The weight management program is designed to help participants lose weight before their prostatectomy and to help them maintain that weight loss after surgery. There are four main components to the weight management program. The four components of the program are:

1. Diet
2. Physical activity
3. Coaching
4. Diet and exercise monitoring tool

The program will be tailored to each individual participant. All participants will be ask to monitor their program using a tool provided by the study team. Participants will be actively participating in the study activities for about 5 months. After that, the study team will review medical records for up to 10 years after enrollment to monitor weight changes and cancer status.

Eligibility Criteria:
Inclusion Criteria:

* Men newly diagnosed with prostate cancer who are scheduled for prostatectomy (Stage T1 or T2)
* Body Mass Index (BMI) 25-45 kg/m2
* Have internet access
* Have an iPad/iPhone/iDevice

Exclusion Criteria:

* History of 5 alpha reductase inhibitors prior 3 months
* History of radiation therapy
* Taking active cancer treatment
* Undergoing salvage therapy
* Castration-resistant prostate cancer
* Evidence of metastasis
* Evidence of biochemical recurrence
* High risk medical condition (e.g. gout or kidney disease)
Human Laboratory Study of Smokeless Tobacco Products

With the advent of restrictions on public smoking, the tobacco industry has introduced a variety of novel smokeless tobacco products (NSTP) to allow continued tobacco use. These products typically have lower tobacco-specific nitrosamines, carcinogens and nicotine than conventional smokeless products out on the market. No studies have compared the effects of NSTP and medicinal nicotine products (MNP) in smokeless tobacco users and whether some of the NSTP products may serve as a cessation tool for smokeless tobacco users. Our hypothesis is that the effects from these products will be directly related to their nicotine content and sensory effects. Products that produce greater effects on outcome measures may serve as potential cessation tools.

Treatment will be a 3-period crossover study using Commit Nicotine Lozenge, Stonewall Disposable Tobacco Pieces and Camel Snus Frost Pouches. Each period will last 14 days with 11 days of product use and 1.5 days abstinence of all nicotine-containing products for a total of 10 weeks. Participants will begin the study by completing a baseline assessment on their own product, Skoal Wintergreen.

Eligibility Criteria:
Inclusion Criteria:

* Subjects will be 20 male smokeless tobacco (SLT) users who are not seeking to quit (less than 5% of females use SLT.
* Subjects will be Skoal Wintergreen SLT users, since this is the most commonly used SLT that uses a mint-type flavorant.
* Subjects will have used SLT for at least 1 year..
* Subjects will be English speaking and reading.
* Provide written informed consent.

Exclusion Criteria:

* Subjects who have used other tobacco products (i.e., cigarettes, cigars) or nicotine products in past 6 months.
* Subjects who take medications that might affect the outcome of laboratory measures.
* Subjects with a history of major mood, thought, anxiety or attentional disorders.
Ultrasound-guided Thermal Ablation for Benign Thyroid Nodules

To evaluate long-term outcomes of ultrasound-guided thermal ablation for benign thyroid nodules

To evaluate and predict long-term clinical outcomes of ultrasound-guided thermal ablation for benign thyroid nodules by a multicenter study

Eligibility Criteria:
Inclusion Criteria:

1. confirmation of benign nodule status on two separate fine- needle aspiration or core-needle biopsy
2. no suspicious malignant features on ultrasound examination
3. report of cosmetic and/ or symptomatic problems or concern of nodules growing rapidly or malignant transformation
4. refusal or ineligibility for surgery
5. follow-up time ≥12 months

Exclusion Criteria:

1. follicular neoplasm or malignancy findings on biopsy
2. nodules with benign result on biopsy had suspicious of malignancy in US
3. patients with contra-lateral vocal cord paralysis
4. previous radiation to the head and neck
5. follow- up time less than 12 months
Epidural Analgesia in Different Cervix Diameter and the Rate of Cesarean Delivery

Epidural analgesia in the early stage of labor at cervix \< 4.0cm was considered as a risk period for increasing the rate of cesarean delivery. The more recent studies and the investigators' previous data indicated epidural analgesia can be performed as early as the cervical dilation approximately 2.0cm. The investigators hypothesized that different cervix diameter had different rate of cesarean delivery. This trial would investigate the correlation amongst different cervical dilation and the risk of cesarean section in nulliparous women at term.


Eligibility Criteria:
Inclusion Criteria:

1. Nulliparous women
2. \> 18 years and \< 45 years
3. Spontaneous labor
4. Analgesia request

Exclusion Criteria:

1. Allergy to opioids, a history of the use of centrally-acting drugs of any sort, chronic pain and psychiatric diseases records
2. Participants younger than 18 years or older than 45 years
3. Those who were not willing to or could not finish the whole study at any time
4. Using or used in the past 14 days of the monoamine oxidase inhibitors
5. Alcohol addictive or narcotic dependent patients were excluded for their influence on the analgesic efficacy of the epidural analgesics;
6. Subjects with a nonvertex presentation or scheduled induction of labor
7. Cervical dilation was 5.0cm or greater before performing epidural puncture and catheterization.
8. Diagnosed diabetes mellitus and pregnancy-induced hypertension
9. Twin gestation and breech presentation.
A Self-Assessment Intervention for Young Adult Polydrug Users at Risk for HIV

The proposed study is a three-armed randomized clinical trial. A total of 750 clients will be randomly assigned (using a random number table) to the interviewer-administered intervention, the self-administered intervention, and waitlist control conditions upon completion of screening, informed consent, HIV pretest counseling and test administration, and collection of baseline risk behavior data. Outcomes will be measured at 3, 6 and 12 months.

The specific aims of the 5-year study are to:

1. identify the covariates of baseline substance abuse and sexual risks (including demographics, social risk measures, peer norms, abuse history, and mental health status) among a sample of 750 heterosexually active, not-in-treatment, club and prescription drug users ages 18 to 39 in Miami, Florida.
2. evaluate, through random assignment, the relative effectiveness of two intervention conditions and a waitlist control in reducing sex risks and drug use, as measured at 3-, 6- and 12-month follow-ups:

   * Arm 1, an interviewer-administered comprehensive health and social risk assessment intervention (CAPI Intervention) similar to the baseline instrument used in the parent grant;
   * Arm 2, an identical self-administered comprehensive assessment intervention (ACASI Intervention); and
   * Arm 3, a waitlist control condition (Control). Outcome measures, including past 90-day counts of unprotected sex acts and days' drug use, will be obtained from brief risk behavior inventories at baseline and follow-ups.
3. conduct qualitative process evaluation research with 40 participants in each study arm to contextualize the study findings and intervention outcomes.

Eligibility Criteria:
Inclusion Criteria:

* heterosexually active
* ongoing club and prescription drug use
* between 18-39 years of age
* must go to local clubs at least two times per month

Exclusion Criteria:

* no current working phone number or e-mail address
* no intention to remain in South Florida for the next 12 months
* new HIV diagnosis in the past 90 days
* currently participating in a drug treatment program (excluding 12-step programs such as Alcoholics Anonymous)
A Study of Lobucavir in Patients With AIDS

The purpose of this study is to see if lobucavir is a safe and effective treatment for cytomegalovirus in patients with AIDS.

Patients receive 1 of 2 doses of lobucavir for 28 days, with 2 weeks of follow-up. Weekly clinic visits are required.

Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed:

* Aerosolized pentamidine.
* TMP / SMX.
* Isoniazid.
* Dapsone.
* Fluconazole.
* Ketoconazole.
* Rifabutin.
* Fluoxetine HCl.
* Acetaminophen.
* Antacids.
* Metamucil.
* Multivitamins.
* Other drugs with approval from sponsor.

Patients must have:

* AIDS.
* CD4 count \< 200 cells/mm3.
* Cytomegalovirus ( CMV ) viruria and virosemenia.
* No evidence of intraocular CMV.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Acute or chronic cardiovascular, pulmonary, renal, hepatic, pancreatic, hematologic, endocrine, neurological, or other unstable illness.
* Inability to take oral medication.
* Allergy to nucleoside analogs.
* Diarrheal illness.
* Poor venous access.
* Positive test for drugs of abuse.
* Any other condition that would render patient unsuitable for study.

Patients with the following prior conditions are excluded:

* History of pancreatitis.
* Recent diarrheal illness.
* History of weight loss.
* Acute serious illness within 4 weeks prior to study entry.

Prior Medication:

Excluded within 4 weeks prior to study entry:

* Erythropoietin.
* Any agent with anti-CMV activity.
* Other investigational agents.

Prior Treatment:

Excluded within 4 weeks prior to study entry:

* Surgery.
* Blood transfusion. Drug abuse.
Ethanol-lock Therapy for the Prevention of Non-tunneled Catheter-related Infection in Pediatric Patients

Central venous catheter (CVC) infection is a common complication in pediatric patients, resulting in prolonged length of stay in hospital, requiring antibiotics, invasive procedures and increase morbidity and mortality. Given the repercussion of this complication, measures that minimize its should be stimulated. The purpose of this study is to evaluate the effects of intraluminal alcoholization (ethanol lock therapy) on prevention of infection of short-term central venous catheters in pediatric patients.

The patients was divided into two groups, where one received alcoholization (ethanol lock therapy group) and the other not (control group). The variables evaluated were: CLABSI, etiological agents, adverse events and the mechanical effects of ethanol on the catheter (breakage and obstruction). To determine the association between the independent variable and the dependent variables, the chi-square test of association (Pearson) and Fisher's exact test were used. The Risk Ratio (RR) was calculated as a relative risk measure, with its 95% confidence interval (95% CI). The significance level of 5% was adopted. The sample size calculation was performed in the OpenEpi software version 2.3.1. And a long-term catheter clinical trial was used to calculate the sample size, which demonstrated a 9% central venous catheter infection frequency in the ethanol group and 37% in the control group, so that the sample size was 80 patients (40 in each group), considering a power of 80%, an alpha error of 5% and 10% of post-randomization losses.

Eligibility Criteria:
Inclusion Criteria:

* Pediatric surgery patients;
* Weight: 2 Kg or more;
* Using non-tunneled double-lumen polyurethane central venous catheter;
* CVC inserted at operation room, Pediatric Intensive Care Unit (PICU) or Neonatal Intensive Care Unit (NICU);
* CVC adequately positioned (checked by radioscopy ou radiography);
* CVC implanted within a maximum of 24 hours.

Exclusion Criteria:

* Patients whose catheters had been inserted under emergency situations;
* Patients in a critical condition (those requiring continuous fluid/drug infusion through both lumens);
* Patients with a history of hypersensitivity or allergic reactions to ethanol were excluded from the study.
Influence of Erythropoietin on Bone Marrow Microenvironment

This will be a prospective observational study. The investigators will compare Erythropoietin (Epo) levels, erythropoiesis, and regulators of erythropoiesis, bone imaging and bone metabolism in healthy volunteers living at different altitudes.


Eligibility Criteria:
Inclusion Criteria:

* healthy men and non-pregnant women, ages ≥18-40 years and ≥ 60 years living in the predefined area
* Exclusion Criteria:
* Known bone pathology including osteoporosis, known haematological disease, known renal disease, heart insufficiency, pulmonal disease
* pregnancy
Feasibility and Therapeutic Potential of Free Fat Grafts in the Treatment of Urethral Strictures

In this study the investigators investigate the feasibility and therapeutic potential of free autologous fat grafting combined to direct visual urethrotomy (DVIU) in the treatment of urethral strictures.

In this study the investigators wish to proof the concept of free fat grafting into urethral stricture via urethroscope. The investigators will recruit twenty male patients suffering from (endoscopy proven) benign stricture of spongy urethra. All recruited patients have undergone at least one direct visual internal urethrotomy (DVIU) before recruitment. IPSS-score and uroflowmetry are recorded upon recruitment. The IPSS-score is repeated one day preoperatively. Urine sample is gathered for bacterial and cytological analysis. Prophylactic single dose levofloxacin antibiotic is orally administered before operation.

The operation is performed in the operation room by one urologist and one surgeon under general anesthesia. First abdominal liposuction (roughly 20 ml) and fat graft preparation is performed. The fat graft is processed into nano-fat using Tulip GEMS Single-Use NanoTransfer Set. Then urethroscopy is performed, urethral stricture is visually graded (location, length, lumen), photographed, DVIU performed and nano fat graft (0,1-0,5ml) injected to stricture site beneath the mucosal layer at three locations. Urinary Foley ch 18 catheter is inserted. Patients are discharged the next day. Urinary catheter is removed after 20 hours.

Patients are contacted by phone 1 week after the operation. Post-operative symptoms are recorded and the patients are requested to contact the researcher if needed. Patient records are screened for pre- and postoperative symptoms, medication, long term illnesses and possible postoperative contacts to the hospital.

Three months later uroflowmetry, urethroscopy and IPSS-questionnaire are repeated. Stricture site is photographed and visually graded. In case of symptomatic re-stricture, the DVIU and fat grafting is repeated once. After 12 months uroflowmetry and IPSS-questionnaire are repeated. In case of suspected re-stricture the urethroscopy is repeated. Follow-up time is 12 months from the last fat graft injection.

Trial starts in fall 2019. The clinical studies have been completed and the data analysis and writing of the manuscript will be finalized in 2022.

Eligibility Criteria:
Inclusion Criteria:

* Urethral stricture that has re-occurred at least once.

Exclusion Criteria:

* Malignant etiology of urethral stricture