cyrilzakka/clinical-trials huggingface dataset:
Geriatric Recovery Using Inpatient and Post-hospitalization Supplementation

The purpose of the study is to determine the feasibility of nutritional interventions designed to help older patients maintain physical function after being in the hospital. We will test the feasibility and effect of nutritional interventions with whey protein, collagen or placebo on functional recovery from hospitalization in community dwelling older adults.

We will compare in a randomized parallel design double blind pilot phase I study the feasibility of whey protein vs. collagen vs. isocaloric placebo supplementation in older adults during an acute hospitalization for a medical condition, and the treatments' effect size on physical function after hospital discharge.

Eligibility Criteria:
Inclusion Criteria:

* Aged 65 years or older.
* Admitted to UTMB hospital for any acute medical condition
* English speaking

Exclusion Criteria:

* Inability to consent
* Bed or wheelchair bound prior to hospitalization
* Estimated creatinine clearance 20 ml/min or less, or end stage renal disease not on dialysis
* AST/ALT 2.5 times above the normal limit
* Active cancer
* Palliative care/Hospice
* Estimated protein intake \>1.2 g/kg/day during the previous 24 hours
* Any other condition or event considered exclusionary by the PI and faculty physician
Treatment of Adult Attention Deficit Hyperactivity Disorder (ADHD) in Methadone Patients - 1

The purpose of this study is to treat Adult Attention Deficit Hyperactivity Disorder (ADHD) in methadone patients.

This project is a three armed double-blind, placebo-controlled, randomized trial comparing the efficacy of MPH and BPR, relative to each other and to placebo, for treating persistent ADHD in methadone-maintained patients. One hundred and twenty subjects, will be randomized to receive either MPH, BPR, or placebo with equal probability. Randomization will be stratified by site, and whether or not cocaine is also being used. Efficacy will be measured by treatment retention, reduction in illicit drug use and drug craving, improvement of ADHD symptoms and overall functional status.

Eligibility Criteria:
Inclusion Criteria:

* Individuals who meet DSM-IV criteria for opiate dependence and are currently maintained on methadone
* Patients must meet DSM-IV criteria for persistent adult ADHD
* Must be on stable methadone dose for at least 3 weeks
* Individuals positive for HIV will not be excluded.

Exclusion Criteria:

* Patients meeting DSM-IV criteria for current psychiatric disorders (other than ADHD or substance abuse) which requires psychiatric intervention
* Patients who are physiologically dependent on either sedatives or alcohol such that they experience symptoms requiring medical attention during periods of abstinence or significant reduction in amount of use
* Individuals diagnosed with other forms of adult ADHD other than persistent, particularly substance-induced ADHD
* Those who have an unstable medical condition which might make participation hazardous, including but not restricted to: uncontrolled hypertension, (SBP \>160, DBP\>100, PULSE \>110), uncontrolled liver disease, uncontrolled diabetes, acute hepatitis, uncontrolled heart disease as indicated by history or abnormal ECG, glaucoma, or history of urinary retention or seizures, or advanced AIDS will not be included
* Patients who are taking prescription psychotropic medications other than methadone
* Patients who have exhibited suicidal or homicidal behavior within the past two years
* Patients with known sensitivity to MPH or BPR
* Patients with cognitive impairment or who cannot read or understand the self-report assessment forms unaided or are so severely disabled they cannot comply with the requirements of the study.
* Patients unable to give full and informed consent
* Patients with a history of an eating disorder
* Patients recently convicted of a violent crime. (last two years)
* Nursing mothers and pregnant women
Effects of Gabapentin Versus Placebo on Buprenorphine Detoxification of Opioid-dependent Individuals

This study involves inducting treatment seeking opioid dependent participants onto buprenorphine. Once the participant reaches a stable dose they will receive either placebo or gabapentin to determine if gabapentin helps ease withdrawal symptoms while the participant undergoes a 10-day buprenorphine detoxification.


Eligibility Criteria:
Inclusion Criteria:

* Availability to attend clinic 6 days a week for approximately 30-60 minutes.
* Participants must fulfill DSM-IV criteria for opioid dependence. These criteria will be ascertained in the following manner: the physician will determine whether the individual is appropriate based on several clinical assessments that are routinely employed by methadone program physicians, including history and severity of opioid use, presence of track marks, prior treatment history, self-reported and/or observed signs and symptoms of opioid withdrawal. If any individual's degree of opioid dependence is questionable, that person will be excluded from further consideration as a participant.
* Participants must submit a urine negative for drugs of abuse other than opioids prior to starting the study.

Exclusion Criteria:

* Unstable medical condition or stable medical condition that would interact with study medications or participation.
* History of major psychiatric disorder (psychosis, schizophrenia, bipolar, depression)
* Pregnancy or plans to become pregnant or inadequate birth control (adequate birth control includes abstinence, condoms, birth control pills, etc).
* Present or recent use of over-the-counter psychoactive drug, prescription psychoactive drug or drug (including Maalox) that would have major interaction with drugs to be tested.
* Liver function tests greater than 3 times normal, BUN and Creatinine outside normal range, or thyroid function tests outside normal range.
* EKG abnormalities including but not limited to: bradycardia (\<60 bpm); prolonged QTc interval (\>450 msec); Wolff-Parkinson White syndrome; wide complex tachycardia; 2nd degree, Mobitz type II heart block; 3rd degree heart block; left or right bundle branch block.
* Physical dependence on alcohol or drugs other than opioids or tobacco (as determined by physician assessment).
A Study to Assess the Efficacy of a Heterologous Prime/Boost Vaccine Regimen of Ad26.Mos4.HIV and Aluminum Phosphate-Adjuvanted Clade C gp140 in Preventing Human Immunodeficiency Virus (HIV) -1 Infection in Women in Sub-Saharan Africa

The primary purpose of this study is to assess the preventive vaccine efficacy (VE), safety and tolerability of a heterologous prime/boost regimen utilizing Ad26.Mos4.HIV and aluminum-phosphate adjuvanted Clade C gp 140 for the prevention of Human Immuno Virus (HIV) infection in HIV-seronegative women residing in sub-Saharan Africa from confirmed HIV-1 infections diagnosed between the Month 7 and Month 24 visits.


Eligibility Criteria:
Inclusion Criteria:

* Sexually active, defined as having had sexual intercourse with a male partner at least twice in the past 30 days prior to screening, and is considered by the site staff to be at risk for Human Immunodeficiency Virus (HIV) infection
* Access to a participating HIV Vaccine Trials Network (HVTN) Clinical Research Sites (CRS) and willingness to be followed for the planned duration of the study
* Willingness to discuss HIV infection risks and willing to receive HIV risk reduction counseling and appropriate referrals to minimize HIV acquisition, as applicable
* Negative beta human chorionic gonadotropin (beta-HCG) pregnancy test performed prior to vaccination on the day of initial vaccination. Persons who are NOT of reproductive potential due to having undergone total hysterectomy or bilateral oophorectomy (verified by medical records), are not required to undergo pregnancy testing
* Participants must also agree not to seek pregnancy through alternative methods, such as artificial insemination or in vitro fertilization until 3 months after the last vaccination

Exclusion Criteria:

* Investigational research agents received within 30 days before first vaccination
* HIV vaccine(s) received in a prior HIV vaccine trial. For volunteers who have received control/placebo in an HIV vaccine trial, the HVTN 705/HPX2008 (Protocol Safety Review Team) PSRT will determine eligibility on a case-by-case basis
* Live attenuated vaccines received within 30 days before first vaccination or scheduled within 14 days after injection (example: measles, mumps, and rubella \[MMR\]; oral polio vaccine \[OPV\]; varicella; yellow fever)
* Any vaccines that are not live attenuated vaccines and were received within 14 days prior to first vaccination (example, tetanus, pneumococcal, Hepatitis A or B)
* Immunosuppressive medications received within 6 months before first vaccination
Impact of GDT in Robot-assisted Laparoscopic Urological Surgery for Low to Moderate Risk Patients

Robot assisted urological procedures are often long surgical cases that can potentially result in complicated postoperative hospital course. The amount of intravenous (IV) fluids administered to patients during these operations fluctuates based on the length of the case, surgical blood loss, hemodynamic monitors, and the discretion of the anesthesiologist. The goal of intraoperative fluid therapy is to maintain optimal tissue perfusion without causing fluid overload. We plan to use a goal directed fluid therapy protocol to optimize fluid status and analyze post-operative outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing robot-assisted laparoscopic urological procedures in which the patient would have an arterial catheter placed as part of their routine inoperative anesthetic management

Exclusion Criteria:

* Age less than 18;
* current pregnancy;
* history of congestive heart failure, arrhythmias, coagulopathy, cerebral vascular disease , COPD, significant liver or renal impairment, required FloTrac per treating anesthesiologist;
* patient refusal to consent
Efficacy of Antenatal Steroids in Reducing Respiratory Morbidities in Late Preterm Infants

The hypothesis of the study is that administration of antenatal steroid to women at high risk of preterm birth after 34 weeks of gestation would reduce the risk of respiratory complications, specifically Respiratory Distress Syndrome (RDS) or Transient Tachypnea of the Newborn (TTN) in late preterm babies.


Eligibility Criteria:
Inclusion Criteria:

* Women between 34 0/7- 36 6/7 weeks of gestation
* High risk of preterm birth

Exclusion Criteria:

* Multiple births
* Fetal congenital malformations
* A course of steroids within 2 weeks of randomization
* Multiple courses of steroids
* Chorioamnionitis
* Non reassuring fetal heart rate
* Obstetrical indication of delivery
* Active bleeding
* Pregnancy related hypertensive disorders
* Uncontrolled diabetes
Endotracheal Intubation Using Videolaryngoscopy Versus Conventional Direct Laryngoscopy

The investigators will evaluate the endotracheal intubation using video laryngoscopy versus conventional direct laryngoscopy on intubation success, quantified by the number of intubation attempts. The question is important because video laryngoscopes are more expensive than conventional direct laryngoscopes. The additional cost might be justified if video systems improve intubation success and reduce airway trauma. But if they do not, the extra cost would not be justified

The investigators propose to enroll participants scheduled for elective or emergent cardiac, thoracic, or vascular surgery in the designated operating room suite who require endotracheal intubation for general anesthesia.

A cluster randomized multiple crossover design is used for this trial. The cardiac surgical suites will be divided into 2 sets of 11 operating rooms. Each set is treated as a unit and randomized to receive video or direct laryngoscopy in 1-week blocks, always with 1 set randomized to each approach. For analysis, each operating room within a set will be considered a separate cluster. Randomization will be conducted weekly on a 1:1 unstratified basis, using computer-generated codes maintained in a web-based system. Investigators access these codes a day before each new treatment block begins.

Eligibility Criteria:
Inclusion Criteria:

* Elective or emergent surgery requiring oral endotracheal intubation for general anesthesia.

Exclusion Criteria:

* The attending anesthesiologist prefers a specific approach for a particular patient
* Awake fiberoptic intubation is clinically indicated
* Insertion of double-lumen tube.
Healthy Relationships Training Study: A Comparison of Interventions to Reduce Dating Violence on College Campuses

The purpose of this study is to compare the efficacy of a mindfulness-based skills training (MBST) to a psychoeducational intervention at reducing dating violence in a sample of college students. The MBST focuses on improving college students' abilities to manage emotionally charged states during conflict with their romantic partners by teaching them mindfulness-based skills. The psychoeducational intervention uses the Love is Not Abuse curriculum. Treatment groups are randomly assigned and are compared using a two-armed parallel design.

88 college students currently in a dating relationship were recruited through Kent State University's subject pool. All participants completed a baseline assessment online where self-reported data was collected on demographics, dating violence (during the past month), emotion regulation, mindfulness skills, and other potential covariates. Participants were then randomized into either the MBST intervention or the psychoeducational intervention. All participants completed three 50-minute sessions over the course of three weeks with assigned homework between sessions. Daily diary data was collected, assessing knowledge and use of skills learned in the sessions. Follow-up data was collected online 11 weeks following baseline (dating violence (during the last month), emotion regulation, mindfulness skills).

It was hypothesized that the MBST intervention would be more effective at reducing dating violence as compared to the psychoeducational intervention.


Eligibility Criteria:
Inclusion Criteria:

* In a current dating relationship (of 6 months or longer)

Exclusion Criteria:

* Diagnosed with psychopathology (Major Depressive Disorder, Post-Traumatic Stress Disorder, Borderline Personality Disorder)
CASITA Intervention for Children at Risk of Delay in Carabayllo, Peru

Building on an intervention for early child development from the SPARK Center in Boston, Socios En Salud (SES) pilot tested "CASITA" a community-based package to screen and treat young children (ages 1-3 years of age) diagnosed with neurodevelopment risk and delay in Carabayllo, Lima, Peru. Ministry of Health CHWs identified children with developmental delays within the clinics and community and delivered a structured early intervention that included parent coaching and social support. In order to test the hypothesis that CASITA improves early child development, caregiver, and home environment, dyads received either nutrition supplements alone, nutrition + "CASITA" early child development sessions individually, or CASITA in a group of 10 dyads.


Eligibility Criteria:
Inclusion Criteria:

1. Age between 6 - 24 months of age;
2. Known primary caregiver (parent or legal guardian) living with child;
3. Living within the catchment area of the 6 Health Centers that comprise the study zone.
4. Screen positive for neurodevelopment delay ("at risk" or "delayed" in neurodevelopment based on Evaluation del Desarrollo Psicomotor (EEDP) assessment).
5. Be at risk by scoring \<45 on the Progress Out of Poverty Index.

Exclusion Criteria:

1. A known medical condition that would make the child unresponsive to early intervention;
2. Family anticipates moving within the next three months.
Treatment of High and Very High riSk Dyslipidemic pAtients for the PreveNTion of CardiOvasculaR Events

High and Very High Risk cardiovascular patient journeys seems to vary from country to country, and current understanding of the process is incomplete. This real-life observational study which documents meaningful patient journey-related parameters can be expected to provide meaningful insight into the care process, country-by-country.

Suffering from hypercholesterolemia is a major health concern in Europe. Appropriate medical treatment lowers low density lipoprotein cholesterol and reduces the incidence of clinical cardiovascular events. Despite the multiple available treatments, many patients remain inadequately treated or even untreated and some lipid-lowering drugs may be associated with an increase in events like side effects or increase in diabetes. As this is a non-interventional study, only data from routine clinical practice will be documented.

Eligibility Criteria:
Inclusion Criteria:

* Very High Risk and High Risk dyslipidemic patients requiring LMTs
* Not simultaneously participating in any interventional study
* Providing written informed consent for participation in the study (Informed consent form)
* Life expectancy \> 1 year

Exclusion Criteria:

* Not applicable; non-interventional study
A Study of TAK-881 With and Without Ramp-Up Dosing in Healthy Adults

The main aim of this study is to check how well healthy adults can tolerate TAK-881 with different dosing schedules.

During the study, participants will receive one infusion of TAK-881 under the skin (subcutaneous \[SC\] infusion) on Day 1 at a lower dose level followed by participants receiving multiple infusion of higher dose levels.

Participants will be in the study for approximately 19 weeks including screening period and follow-up (End of Treatment \[EOT\]).


Eligibility Criteria:
Inclusion Criteria:

1. Men and Women between 18 and 50 years can participate.
2. Must be a non-smoker, with no use of nicotine or tobacco products for at least 3 months prior to the first dosing.
3. Must have Body Mass Index (BMI) between 18.0 and 30.0 kilograms per square meter (kg/m\^2).
4. Must be medically healthy.
5. Must follow protocol-specified contraception guidance.

Exclusion Criteria:

1. Any current or past medical history of blood/clotting disorder, liver, lung, heart, kidney, immune, skin, or brain or psychiatric condition.
2. History of alcohol or drug abuse within 2 years before dosing.
3. History or presence of hypersensitivity or severe allergic reactions to blood or blood components.
4. History or presence of thrombotic/thromboembolic events, or venous thrombosis.
5. Pregnant or breastfeeding.
6. Unable to refrain from taking prescription and non-prescription medications, herbal remedies, homeopathic preparations, or vitamin supplements.
7. Recently donated blood or blood products.
8. Participated in another clinical trial involving immunoglobulin products within 12 months of screening.
9. Has taken biologic agents within 12 weeks of screening.
10. Has used an investigational product within 30 days or 5 half-lives, whichever is longer, prior to screening.
11. Has received any vaccine (including live attenuated vaccines and coronavirus disease 2019 \[COVID-19\] vaccines) during the last 30 days before dosing.
Heartland Osteoporosis Prevention Study

The purpose of this study is to identify the best way to prevent bone loss in the first years after menopause. The HOPS study will compare bone loss at 12 months in women: 1) who take calcium and vitamin D only; 2) who take calcium and vitamin D plus the medication "risedronate"; or 3) who take calcium and vitamin D plus participate in bone-loading exercises. Our central hypothesis is that improvements in bone health will be greater in women randomized to bone-loading exercises with calcium and vitamin D compared to women who take calcium and vitamin D only or women who take calcium and vitamin D plus risedronate.

This randomized controlled trial (RCT) will compare changes after 12 months in bone structure, bone mineral density (BMD), and bone turnover in women with low bone mass who are within 5 years of menopause. Women will be randomized to one control and 2 treatment groups (n =103 per group): 1) calcium + vitamin D (CaD) alone (Control); 2) Bisphosphonate (BP) plus optimal CaD (Risedronate); and 3) a bone loading exercise program plus optimal CaD (Exercise). Our central hypothesis is that improvements in bone health will be greater in subjects randomized to the exercise group compared to subjects in either the control or risedronate groups. Specific Aims: Aims 1, 2, and 3 are to compare control, risedronate, and exercise group subjects on changes in bone structure at the tibia and hip (measured by pQCT and Hip Structural Analysis) (Aim 1) ; on changes in BMD at the total hip, femoral neck, and spine (Aim 2); and on changes in serum markers of bone formation and resorption (Aim 3). In addition, Aim 4 will explore relationships between adherence to exercise (% sessions attended) or adherence to risedronate (% pills taken) and changes in bone structure.

Eligibility Criteria:
Inclusion Criteria:

* Women who are in their first 5 years of menopause
* Have a T score between -1 and -2.49 at the femoral neck, total hip, or L1-L4 spine
* Be 19 years of age or older
* Have their health care provider's permission to enroll in the study.

Exclusion Criteria:

* Have osteoporosis
* Have a 10 yr probability of hip fracture \>3% or major fracture \>20% based on results of the fracture risk assessment (FRAX) tool
* Currently take bisphosphonates, estrogen replacement therapy, glucocorticosteroids, or other drugs affecting bone
* Currently participate in a resistance training or high impact weight bearing exercise program three or more times weekly
* Weigh \>300 lbs
* Have abnormal results for the following laboratory tests: serum 25(OH)D; serum creatinine; serum calcium; parathyroid hormone (PTH); thyroid stimulating hormone (TSH).
* Have Paget's disease, heart disease, uncontrolled hypertension, renal disease, or other concomitant conditions that prohibit participation in exercises, risedronate therapy, or use of CaD supplements.
Linear Ablation Versus Focal Ablation of Complex Fractionated Atrial Electrograms in Persistent Atrial Fibrillation

The end point of catheter ablation at complex fractionated atrial electrograms (CFAE) was not established yet. Furthermore, incomplete CFAE ablation may have a potential to develop atrial tachyarrhythmias (AT). The investigators hypothesized that linear ablation extending the clusters of CFAE would be a better strategy than focal ablation at the individual CFAE sites.


Eligibility Criteria:
Inclusion Criteria:

* patients age 18 or greater
* persistent atrial fibrillation
* candidates for AF ablation based on AF that is symptomatic and refractory to at least one antiarrhythmic medication
* at least one episode of AF must have been documented by ECG or Holter within 12 months of randomization in the trial
* continuous anticoagulation with warfarin (INR 2-3) for \>4 weeks prior to the ablation
* patients must be able and willing to provide written informed consent to participate in the clinical trial

Exclusion Criteria:

* paroxysmal or permanent atrial fibrillation
* patients with AF felt to be secondary to an obvious reversible cause
* inadequate anticoagulation as defined in the inclusion criteria
* left atrial thrombus on TEE prior to procedure
* contraindications to systemic anticoagulation with heparin or coumadin
* previously undergone atrial fibrillation ablation
* patients who are or may potentially be pregnant