cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Subacute Rehabilitative Care

Prior rehabilitation outcome studies had many weaknesses. They had: a) evaluated rehabilitation effects only in isolated subgroups, b) focused on functional ability rather than on quality of life, c) not used randomized control groups, and d) had inadequate sample sizes. Differences in methodological approaches have resulted in inconsistent findings. The lack of long-term benefits suggests that services may need to be continued at home or in subacute care settings to optimize their effectiveness. Unfortunately, prior research did not include behavioral outcomes. The potential benefits of rehabilitative care could thus not be evaluated by these studies in more meaningful detail, and they did not accurately reflect the psychosocial objectives of rehabilitation.

Background:

Prior rehabilitation outcome studies had many weaknesses. They had: a) evaluated rehabilitation effects only in isolated subgroups, b) focused on functional ability rather than on quality of life, c) not used randomized control groups, and d) had inadequate sample sizes. Differences in methodological approaches have resulted in inconsistent findings. The lack of long-term benefits suggests that services may need to be continued at home or in subacute care settings to optimize their effectiveness. Unfortunately, prior research did not include behavioral outcomes. The potential benefits of rehabilitative care could thus not be evaluated by these studies in more meaningful detail, and they did not accurately reflect the psychosocial objectives of rehabilitation.

Objectives:

The goal of this study was to measure the additive effect of outpatient, subacute rehabilitation as follow-up services to acute, inpatient rehabilitation on adults diagnosed with a disabling disorder in four major diagnostic groups (nervous, circulatory, musculoskeletal, and injury).

Methods:

A randomized clinical trial was conducted to determine the effects of subacute rehabilitative care on: 1) physical function, 2) health and mental health, 3) mortality, 4) family function, 5) personal adjustment, and 6) use of health care resources. Patients hospitalized for the first time with a disabling condition \[n=180\] were provided inpatient rehabilitation and then randomly assigned to either subacute rehabilitation at home \[n=90\] or to usual outpatient follow-up \[n=90\] in which only medical services were provided but no scheduled rehabilitative therapies were offered. To compare the two groups, analysis of covariance was conducted for the outcome variables. The between subjects factor was subacute rehabilitative care versus usual medical services as an outpatient.

Status:

Complete.

Eligibility Criteria:
Inclusion Criteria:

Presence of physical limitation and need for rehabilitative care as indicated by a score \>1 (not independent) on the Nursing Ward Classification index; availability of a family member selected by the patient; Major Diagnostic Code (MDC) 1, 5, 8, or 21 (comprising 87% of cases)

Exclusion Criteria:
Assessing the Effects of Three Oral Care Regimens

Assessing the effects of three oral care regimen on plaque, gingivitis, and tooth whitening: A randomized, person-centric, comparative effectiveness clinical research study by the Practitioners Engaged in Applied Research and Learning (PEARL) Network.

Six month, five visit study of plaque, gingivitis, and tooth whitening with three randomized intervention groups using FDA marketed and approved products and devices. One hundred fifty (150) subjects from the patient base of 10 PEARL Network associated dental offices on the East Coast of the United States will be entered into the clinical research study. This is a post-marketing comparative effectiveness research study. Having a total of 5 visits over a six month period. Adverse events and side effects for the products used are being assessed.

Eligibility Criteria:
Inclusion Criteria

1. Subject males or females 18 to 70 years old (inclusive).
2. Availability for the 6 months duration of the clinical research study
3. Good general health
4. Subject able and willing to follow study procedures and instructions
5. Subject read, understood and signed an informed consent form
6. Subject present with at least 20 natural teeth in the functional dentition (excluding third molars), including the following natural (uncrowned) teeth for shading: #6, #7, #8, #9, #10, #11

Exclusion Criteria

Potential subjects must NOT HAVE ANY of the following conditions:

1. Presence of orthodontic bands
2. Presence of partial removable dentures
3. Tumor(s) of the soft or hard tissues of the oral cavity
4. Restorations or crowns that would interfere with color measurements on the following teeth: #6, #7, #8 , #9, #10 \& #11 (upper six front teeth)
5. Advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone)
6. Five or more carious lesions requiring immediate restorative treatment
7. Antibiotic use any time during the one month prior to entry into the study
8. Participation in any other clinical study or test panel within the one month prior to entry into the study
9. History of allergies to oral care/personal care consumer products or their ingredients.
10. On any prescription medicines that might interfere with the study outcome
11. An existing medical condition which prohibits eating or drinking for periods up to 4 hours
12. History of alcohol or drug abuse
13. Pregnant or lactating
Protease Inhibitors and Combined Oral Contraceptive Pharmacokinetics and Pharmacodynamics

The project is a two-arm prospective cohort and pharmacokinetic study comparing levonorgestrel and ethinyl estradiol pharmacokinetics in HIV-positive women taking antiretroviral regimens that include ritonavir to those in women who take regimens known not to interact with combined oral contraceptives. In addition, the prevalence of ovulation will be measured in each group. Participants will take a combined oral contraceptive containing levonorgestrel and ethinyl estradiol for 21 days, during which they will undergo twice-weekly serum progesterones. On the final day, they will complete a pharmacokinetic study. The investigators hypothesize that levonorgestrel levels, as measured by area-under-the-curve from 0 to 72 hours, will be increased in women on ritonavir, while ethinyl estradiol levels will be decreased and ovulation, defined by a serum progesterone of at least 3 ng/mL, will be unchanged.

This study will be the first to evaluate the effects of ritonavir on the pharmacokinetics of a combined oral contraceptive containing the progestin levonorgestrel. In addition, no previous studies have rigorously assessed ovulation in women taking protease inhibitors and combined oral contraceptives. As a result, this study will provide new information correlating pharmacokinetic changes with effects on ovulation.


Eligibility Criteria:
Inclusion Criteria:

* HIV positive
* Female
* Age 18-45
* Using any of the following medication regimens: no ARV medication, entry inhibitors, nucleoside reverse transcriptase inhibitors (NRTIs), integrase inhibitors, and CCR5 agonists. Acceptable NRTI combinations include zidovudine (ZDV), lamivudine (3TC), emtricitabine (FTC), didanosine (ddl), stavudine (d4T), abacavir (ABC), and tenofovir disoproxil fumarate (TDF)
* Ovulatory (mid-luteal progesterone \>3ng/dL)
* Not planning to conceive during the study period
* Willing to abstain from grapefruit products
* If taking ritonavir, willing to use alternate non-hormonal contraception
* BMI \< or = 40
* Able to consent in English or Spanish
* No change in medication regimen for at least 21 days prior to study entry and no planned change during the study period
* CD4 \> or =200, and/or not considered profoundly immuncompromised by primary HIV provider

Exclusion Criteria:

* Using on the combination of ZDV at d4T
* Platelets \<50,000
* AST or ALT \> twice upper limit of normal
* Bilirubin \> twice upper limit of normal
* Use of other CYP3A4 inducing or inhibiting medications
* Pregnant or breastfeeding in last 30 days
* Use of DepoProvera in last 180 days
* Use of any other hormonal contraception in last 30 days
* Undiagnosed vaginal bleeding or invasive cancer of the reproductive tract

  -\>50% change in tobacco use in the last month
* Initiation or titration of methadone therapy in the last month
* Uncontrolled thyroid disease
* Contraindication to estrogen use
* Inability to comply with study protocol
Dairy Products, Diabetes and Genetics

This study will investigate the in-depth the benefits of dairy consumption on glucose metabolism in patients at risk of type 2 diabetes using novel genomics methodology.To do so, 33 individuals at risk of type 2 diabetes will be randomly subjected to an intervention study including a 6-week intensive dairy product consumption period and a 6-week dietary counselling period.

More than 9 million Canadians are living with diabetes or prediabetes. Type 2 diabetes is a disorder characterized by high blood glucose. Dietary modification is a key component in type 2 diabetes management. For example, dairy product consumption has beneficial effects on metabolic health. Yet, researchers have shown that mixed results exists for insulin sensitivity.

Eligibility Criteria:
Inclusion Criteria:

* Caucasian men and postmenopausal women (absence of menstrual cycles for \>12 months) aged \>18 yrs;
* BMI between 25-40 kg/m2;
* Hyperinsulinemia (fasting plasma insulin \>90 pmol/l);
* Fasting plasma glucose (FPG) \<7.0 mmol/l; HbA1c \<6.5%);
* If treated with lipid-lowering agents, the dose must have been stable over the last 3 months;
* Stable body weight (±5%) for 3 months;
* Willing to consume study foods and able to follow protocol and give informed consent.

Exclusion Criteria:

* Failure to meet any one or more of the inclusion criteria;
* Diagnosis of type 2 diabetes;
* High dairy consumption ( 2 servings/day or more);
* Major surgery in the 3 months prior to study onset;
* Smoking;
* Incompatibility with dairy consumption (allergy, intolerance or dislike);
* Inflammatory bowel disease or other gastrointestinal disorder influencing gastrointestinal motility or nutrient absorption;
* Medications known to affect lipid and glucose metabolism other than those used to treat hypertension or dyslipidemia;
* Diseases known to affect glucose metabolism.
Platinum Plus Low-dose Long-term Continuous Intravenous Infused 5-Fluorouracil in Recurrent Nasopharyngeal Carcinoma

Local control rates of nasopharyngeal carcinoma are increasing, but 15% of patients still have local recurrence within 5 years after initial treatment. Systematic treatment based on chemotherapy has become the mainstream approach for recurrent nasopharyngeal carcinoma which is intolerant to local therapy. we sought to find an efficient chemotherapy regimen with high tolerance according to the characteristics of chemotherapy drugs, that is, to explore the efficacy and safety of platinum plus 5-fluorouracil with continuous intravenous infusion at a low dose for a long term.

Nasopharyngeal carcinoma (NPC) is a malignant tumor of the nasopharyngeal epithelium with high sensitivity to ionizing radiation, but failure in local control was observed in approximately 15% of patients.

Chemotherapy is the cornerstone of the treatment of recurrent NPC. Many studies were aimed at the systemic treatment of recurrent NPC, but most of them were retrospective studies or phase II trials with small samples. Platinum-containing doublet chemotherapy is generally regarded as the standard treatment for recurrent NPC. After a multicenter phase III randomized clinical trial was published in 2016, gemcitabine plus cisplatin is recommended, however, less than 60% of patients could complete the treatment in the trail. Finding a proper regimen with promising efficacy results as well as high tolerance is still a big challenge.

Cisplatin plus 5-fluorouracil (PF) is a classical regimen widely used in recurrent NPC. The continuous infusion of 5-fluorouracil with low dose was investigated in esophagus carcinoma, rectal carcinoma and prostate carcinoma with encouraging outcome and acceptable toxicity. Whereas, data of platinum containing chemotherapy with low-dose continuous infused 5-fluorouracil in recurrent NPC was absent. In this study, we aimed to investigate the antitumor activity of platinum plus low-dose long-term continuous intravenous infused 5-fluorouracil (PFLL).

Eligibility Criteria:
Inclusion Criteria:

- patients involved in our study were patients who had histologically or cytologically confirmed NPC with diagnosed recurrent NPC during 2006-2018 and receiving treatment in our hospital.

Exclusion Criteria:

* Age \<18 or \>70 years old

  * Pathologic type unknown or except type I-III of World Health Organization classification
  * Never underwent platinum-based chemotherapy
  * Lack of information about T classification and N classification when metastasis
  * Lost follow-up within one month from the start of treatment for metastasis
  * With other malignances
Transcutaneous Electrical Nerve Stimulation on Pain Intensity of Patients With Hip Arthroplasty

Fifty patients with hip arthroplasty were purposively recruited for the study. They were allocated into two groups randomly with equal number. One group had TEN, other served as control. Pain intensity was measured every day of the treatment.

Subjects that participated were post-surgical patients with hip arthroplasty receiving treatment at Orthopedic Ward of Obafemi Awolowo University Teaching Hospitals Complex (OAUTHC), Ile-Ife. Excluded from the study were subjects who had surgery but have infected wound, those with deep vein thrombosis, and those with thrombophlebitis post-surgery. The subjects were allocated randomly into 2 groups; one group of 25 patients was on TENS (experimental group) and the other group of 25 patients was on their normal drugs without TENS (control group). Before the start of intervention, the procedure of the intervention and the way the subject would feel during the course of the intervention was explained to the subject and the consent of the patient was obtained. The procedure was as follows:The Visual Analogue Scale and Oxford hip score was administered prior to the treatment to ascertain their pain level and hip disability before the treatment. The site of intervention (5cm away from incision site) was cleaned properly with cotton wool soaked in methylated spirit in an outward motion. Before the self-adhesive, pre gelled electrodes was placed on the cleansed sites. The TENS unit was switched on and the parameters was adjusted to the required. For this study, parameters used are: 100µs pulse duration, 100Hz frequency and an intensity comfortable for the patient for a duration of 15 minutes.

At the expiration of treatment, the electrodes were removed. The treatment was carried out twice a day for three days in addition to the normal analgesic and antibiotics drugs taken by the patient. After the last treatment session, VAS and Oxford hip score was re-administered to ascertain their pain intensity and hip disability level.

For the group with no intervention The VAS and Oxford hip score was administered on the first day of contact to ascertain pain intensity and hip disability level . The subject continued on the normal analgesics only till the third day and VAS and Oxford hip score was re-administered to ascertain their pain intensity and hip disability level.

Eligibility Criteria:
Inclusion Criteria:

Patients who recently had hip arthroplasty were recruited for this study

Exclusion Criteria:

* Subjects who had surgery but have infected wounds.
* Patients who had deep vein thrombosis post-surgery.
* Patients who had thrombophlebitis post-surgery.
Clinical Data Registry of Amblyopia Patients on Luminopia Treatment

Amblyopia is the most prevalent cause of reduced monocular visual acuity in children and young adults, with estimates of prevalence ranging from 1% to 5%. The most common associated amblyogenic risk factors are uncorrected anisometropia, strabismus, or a combination of these. In addition to reduced visual acuity, amblyopic patients may also have measurable dysfunction of accommodation, fixation, binocularity, vergence, reading fluency, depth perception, and contrast sensitivity.

For the first time since the incorporation of atropine penalization into amblyopia management, physicians can now offer Luminopia, an FDA-approved dual action dichoptic treatment, to patients with amblyopia. Since the product became commercially available in November 2022, the number of patients on Luminopia therapy continues to grow. This presents a unique opportunity to gather real world evidence from a large number of patients, representative of how ophthalmologists and optometrists are applying this novel treatment in the real world. A registry of the clinical data associated with Luminopia treatment, with IRB oversight, will provide answers to key scientific questions using a large dataset.


Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of amblyopia
* Have undergone or currently undergoing Luminopia treatment for a minimum of 12 weeks

Exclusion Criteria:

-Have participated in prior Luminopia clinical trials
Advanced Care Coordination and Enhanced Linkage and Retention Among Transitional Re-Entrants

The overarching goal of this study is to develop a peer-based care coordination intervention for individuals with Hepatitis C Virus (HCV) who were recently released from correctional settings to promote linkage to and retention in HCV care. The investigators will assess the existing barriers and facilitators of HCV treatment initiation, HCV treatment completion, and sustained virologic response among individuals recently released from a U.S. jail or prisons in a randomized control trial. This study will assess the feasibility and process measures of a peer-enhanced HCV care coordination intervention among recently incarcerated individuals.

The proposed 2-year study will be a block stratified, randomized controlled trial. Once consented and enrolled, participants will be randomly assigned to either the peer-enhanced intervention or referred to standard clinical care. The investigators will enroll 80 former inmates with chronic HCV who have been released from incarceration within the past 6 months. It is expected that enrollment will be completed by the fourth quarter of the first year. This will allow sufficient time for HCV treatment uptake, completion, determination of Sustained Virologic Response (SVR), and assessment of reinfection. Individual participant follow-up will be 3 months on average for treatment, 3 months for SVR, and 3 months to assess for reinfection.

Elucidating the barriers and facilitators in the re-entry care cascade (as well as how they may be overcome) will be critical in designing sustainable models of care for HCV-infected former inmates. The investigators hypothesize that a peer-enhanced strategy will be more effective than standard referral in improving linkage to, and retention in, HCV care among individuals recently released from correctional settings.

Eligibility Criteria:
Inclusion Criteria:

* currently incarcerated or recently released from a U.S. jail or prison (6 months)
* Chronic HCV with documented detectable viral load
* 18 years old
* Fluent in English or Spanish
* Resident of the Upstate area of South Carolina

Exclusion Criteria:

* Unable to sign informed consent
* Life expectancy of less than 1 year
* Plans to relocate from the Upstate area of South Carolina in the next 6 months
Validity and Reliability in Measuring Biceps and Triceps by Using Ultrasound

The purpose of this study is to estimate the validity and reliability in the measurement of bicep and tricep tendons and muscular morphologic characteristics by using ultrasound.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects
* Age range from 19-35 years

Exclusion Criteria:

* History of shoulder or elbow pain which needs medical treatment or surgery
The Status of Autonomic Tone Before Tourniquet Deflation During Total Knee Replacement

This study evaluates the influences of the status of sympathovagal balance before tourniquet deflation on a decrease in arterial blood pressure following the deflation during total knee replacement arthroplasty

Patients present with different hemodynamic profiles after intraoperative tourniquet deflation during total knee replacement arthroplasty.

Sympathovagal balance can be measured before tourniquet deflation and might determine the hemodynamic response to tourniquet deflation.

Eligibility Criteria:
Inclusion Criteria:

1. American Society of Anesthesiologists physical status I - II
2. Body mass index \< 35 kg/m2

Exclusion Criteria:

1. Coagulation deficiencies
2. Known allergies to local anesthetics
3. Neurologic deficit on the side being operated on
4. Inflammation at the lumbar puncture site
5. Cardiac conduction disorders or arrhythmias
6. Congestive heart failure
7. Serum electrolyte abnormalities
8. Psychiatric disorders
9. Patient's refusal
10. Difficulty communicating with medical personnel
11. Severe hypovolemia
12. Increased intracranial pressure
13. Severe aortic stenosis
14. Severe mitral stenosis
In Vitro Studies of Immunological and Stem Cell Function in Peripheral Blood Mononuclear Cells in Patients

Peripheral blood mononuclear cells (PBMC) will be collected from patients who have leukemia or lymphoma or other medical conditions involving altered lymphohematopoietic stem cell or immunological function. These PBMC will be assessed for cellular markers by flow cytometry and will be studied for in vitro T helper, effector and suppressor cell functions, to determine whether cell mediated immunity is involved in the condition, or indicative of therapeutic efficacy or is predictive for outcome. Peripheral blood stem cells (PBSC) from untreated donors and from cytokine treated donors will be assessed for cellular markers and in vitro growth characteristics that might be useful for identifying normal stem cell populations.

Peripheral blood mononuclear cells (PBMC) and mobilized peripheral blood stem cells (PBSC) will be collected from patients who have leukemia or lymphoma or other medical conditions involving altered lymphohematopoietic stem cell or immunological function. These PBMC will be assessed for cellular markers by flow cytometry and will be studied for in vitro T helper, effector and suppressor cell functions, to determine whether cell mediated immunity is involved in the condition, or indicative of therapeutic efficacy or is predictive for outcome. PBSC will be assessed for cellular markers and in vitro growth characteristics that might be useful for identifying normal stem cell populations. Furthermore the capacity of stem cells to reconstitute the T lymphocyte lineage will be assessed using ex vivo explant cultures established with thymic or secondary lymphoid tissues.

Eligibility Criteria:
Patients obtained from collaborators within and outside the NCI.
Study of PRX302 for Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia (BPH)

The purpose of this study is to evaluate the safety, tolerability and efficacy of a single treatment of PRX302 for the treatment of Benign Prostatic Hyperplasia (BPH) as compared to placebo.


Eligibility Criteria:
Inclusion Criteria:

* Lower Urinary Tract Symptoms (LUTS) attributable to BPH for ≥6 months
* Written informed consent prior to enrollment in the study
* IPSS ≥12
* Prostate volume of 30 - 100 mL as determined by TRUS
* Maximum urine flow (Qmax) of 4 - 15 mL/sec
* Refractory, intolerant or refused the use of alpha-blockers and/or 5 alpha-reductase inhibitors
* Unwilling or unable to undergo conventional surgical or available minimally invasive treatments
* Blood PSA values \<10 ng/mL

Exclusion Criteria:

* Inability to void at least 125 mL of urine
* PVR volume \>200 mL
* Presence of or history of certain conditions that could interfere with study results or endanger subject
* Use of certain prescribed medications that could interfere with study results