cyrilzakka/clinical-trials huggingface dataset:
Developing a Resiliency Intervention to Support Healthcare Workers Engaged in the Provision of HIV Care

The purpose of this study is to pilot an adapted resiliency-based mind-body intervention (the Relaxation Response Resiliency Program; the 3RP) for nurses that care for people with HIV (PWH) in the public sector in South Africa (SA). In Phase 1 \[NIH Grant Number: R34MH131426; Human Research Ethics Committee (HREC) Ethics Reference Number: 220813\], the investigators conducted focus group discussions to solicit feedback on: the role of culture and perceptions of stress; the lived experiences of stress; sources of stress (e.g. occupational, trauma related); how stress impacts job functioning (specifically patient care); current coping strategies; and the intervention modules (content, number of sessions, session duration, program length, mode of delivery (e.g., virtual, in-person, hybrid approaches, use of coaches), etc.). In this phase 2, the investigators will conduct a small proof-of-concept study (N = 8-10), followed by a randomized pilot (N = 60) of nurses that care for PWH in the public sector in South Africa (SA) to test the feasibility and acceptability of the adapted intervention.

This study will pilot test an adapted version of an existing stress management and resiliency-enhancing intervention (the Relaxation Response Resiliency Program; the 3RP) for nurses that care for PWH in the public sector in SA, to test the feasibility and acceptability of all study procedures. This intervention was adapted and refined from its original format (which consisted of eight, 90-minute weekly group sessions) following focus group discussions (FGDs) that explored nurses' preferences and desired modifications to the intervention (Phase 1 of this study).

This trial will involve a randomized pilot study (N = 60) to test the feasibility and acceptability of the adapted intervention among nurses that care for PWH in the public sector in SA.

Additionally, the randomized control trial (RCT) will collect anonymous clinic client data on demographics, satisfaction with care, client-provider trust, and likelihood of returning to care. We will also collect clinic-level data to understand how to measure client-related outcomes and clinic metrics of HIV care engagement, such as expected patient return rates/measures of retention, percentage of patients with suppressed viral load, frequency of viral load collection, and percentage of patients initiating second line treatment to best understand how to measure these variables in a larger trial testing the efficacy of the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Providing at least some primary HIV care in a public sector clinic (at the level of professional nurse) for at least one year;
* IsiZulu or English speaking;
* Able and willing to sign informed consent.

Exclusion Criteria:

- Participation in cognitive behavioral therapy and/or a mind-body intervention in the past year.
Bioequivalence of a 2.5 mg Linagliptin / 850 mg Metformin Fixed Dose Combination Tablet Compared With Single Linagliptin 2.5 mg and Metformin 850 mg Tablets in Healthy Volunteers

Study to assess bioequivalence of a 2.5 mg linagliptin / 850 mg metformin fixed dose combination (FDC) tablet compared to single tablets of linagliptin 2.5 mg and metformin 850 mg administered together


Eligibility Criteria:
Inclusion Criteria:

1. Healthy men and women according to the following criteria: based upon a complete medical history, including physical examination, vital signs (Blood pressure (BP), Pulse Rate (PR)), 12-lead ECG, clinical laboratory tests
2. Age 18 to 55 years (inclusive)
3. Body mass index (BMI) 18.5 to 29.9 kg/m2 (inclusive)
4. Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation

Exclusion Criteria:

1. Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
2. Any evidence of a clinically relevant concomitant disease
3. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
4. Surgery of the gastrointestinal tract (except appendectomy)
5. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
6. History of relevant orthostatic hypotension, fainting spells or blackouts
7. Chronic or relevant acute infections
8. History of relevant allergy or hypersensitivity (including allergy to drug or its excipients)
9. Intake of drugs within 1 month or less than 10 half-lives of the respective drug prior to first study drug administration
10. Participation in another trial with an investigational drug within 2 months prior to administration or during the trial
11. Smoker (more than 10 cigarettes or 3 cigars or 3 pipes daily)
12. Alcohol abuse (average consumption of more than 20 g/day in women and 30 g/day in men)
13. Drug abuse
14. Blood donation (more than 100 mL within 4 weeks before Day 1 of Visit 2)
15. Any laboratory value outside the reference range of clinical relevance
16. Inability to comply with dietary regimen of trial site

    For female subjects of childbearing potential only:
17. Positive pregnancy test, pregnancy or planning to become pregnant during the study or within 2 months after study completion
18. No adequate contraception during the study and until 1 month after study completion, e.g. not any of the following: implants, injectables, combined hormonal contraceptives, hormonal intrauterine device, sexual abstinence for at least 1 month prior to first study drug administration, vasectomised partner (vasectomy performed at least 1 year prior to enrolment), or surgical sterilization (including hysterectomy). Women who did not have a vasectomised partner, were not sexually abstinent or surgically sterile were asked to use an additional barrier method (e.g. condom).
19. Lactation
The Impact of Actos Treatment of Diabetes on Glucose Transporters in Muscle

Subjects with type 2 diabetes will be treated with Actos or placebo for eight weeks and needle biopsies of muscle will quantify changes in any of seven different glucose transport proteins in muscle.

Twelve subjects with type 2 diabetes, with fair control on oral medication, will be recruited to participate in a randomized, double-blind, placebo-controlled study of the impact on muscle glucose transporter expression of the addition of the insulin-sensitizing agent, pioglitizone (Takeda Pharmaceuticals). Therapy with the active drug will be at 30 mg daily. The other oral medications will be adjusted downward if hypoglycemia occurs. Glycemic control will be monitored by at least twice daily home blood glucose monitoring, weekly telephone contacts, and follow-up visits to the ETSU/VAMC Clinical Research Unit (CRU) every two weeks. During the eight weeks of therapy, subjects will be instructed to maintain their weight and keep their dietary and exercise regimens unchanged. Muscle biopsies will be obtained before and at the end of eight weeks of therapy. Specimens will be assayed for GLUT1, GLUT3, GLUT4, GLUT5, GLUT8, GLUT11, and GLUT12 mRNA and protein content and the subcellular distribution of these proteins as described below. Peroxisome proliferator-activated receptor gamma (PPARgamma), a member of the ligand-activated nuclear hormone receptor superfamily (14), will be quantified in these specimens by immunoblot as described below.

This study design involving a randomized, double-blinded, placebo-controlled treatment regimen is needed to control for confounding variables causing changes in glucose transporter expression that may be erroneously attributed to the drug. These potential variables include close contact with the diabetes management team resulting in improved compliance with diet, exercise, medication, and monitoring and thus better glycemic control, weight loss, or improved fitness.

Eligibility Criteria:
Inclusion Criteria:

* diabetes, type 2
* HbA1c less than 8.5

Exclusion Criteria:

* insulin therapy
* renal insufficiency
* clinically apparent coronary disease
A Study of Carbon-14-Labelled [14C] LY3473329 in Healthy Male Participants

The main purpose of this study is to evaluate how much of the study drug (LY3473329), administered as a single dose that has the radioactive substance 14C incorporated into it, passes from blood into urine, feces and expired air in healthy male participants. The study will also measure how much of the study drug gets into the bloodstream when taken orally, compared to when injected directly into the vein, how its broken down, and how long it takes the body to get rid of it. The study is conducted in two parts. The study will last up to approximately 9 and 7 weeks for part 1 and 2, respectively.


Eligibility Criteria:
Inclusion Criteria:

* Male participants who are overtly healthy as determined by medical evaluation
* Have a body mass index of 18.0 to 35.0 kilograms per meter squared (kg/m²), inclusive
* Males who agree to use highly effective or effective methods of contraception

Exclusion Criteria:

* Have known allergies to LY3473329, related compounds, or any components of the formulation, or history of significant atopy
* Have a history of constipation or have had acute constipation within 3 weeks prior to check-in
* Have participated in any clinical study involving a radiolabeled investigational product within 12 months prior to check-in. Any previous radiolabeled study intervention must have been received more than 12 months prior to check-in
* Have used or plan to use over-the-counter or prescription medication within 14 days prior to dosing, or any medications or products known to alter drug absorption, metabolism, or elimination processes
* Have participated, within the last 3 months, in a clinical study involving an investigational product
Physical Activity Telehealth Intervention After Percutaneous Coronary Procedures

The purpose of this study is to test the feasibility of using targeted daily cell phone interaction to facilitate behavior change for physical activity in previously-sedentary individuals who have recently undergone a percutaneous coronary intervention (PCI).

Regular physical activity is important in the maintenance of cardiovascular health, and is especially critical for previously sedentary individuals who have undergone percutaneous coronary intervention (PCI) procedures. Changing behavior to adopt and maintain recommended physical activity levels in this population is difficult. Interventions to accomplish behavior change will not work unless they can be adopted into a person's busy lifestyle. This proposed study fills a gap by testing the feasibility of an innovative, targeted intervention (Physical Activity Promotion Telehealth Intervention), delivered by a practical and feasible platform (cell phone). The asynchronous targeted daily interaction will consist of 5-6 text, picture, and/or video messages delivered to the subject's cell phone each day. Upon successful completion of this study, it is believed that these feasibility findings will provide a foundation for the testing of a larger clinical trial to promote physical activity in this population.

Eligibility Criteria:
Inclusion Criteria:

* First-time PCI cardiac revascularization
* Age of 19 years or older
* Residing in a rural community
* Previously sedentary
* Physician approval to participate in this study
* Oriented to person, place, and time
* Able to see and hear (able to read the screen of a cell phone, and hear audio over a cell phone)
* Able to speak and read English.

Exclusion Criteria:

* Residing in area of Nebraska that does not have cell phone transmission
* Physical impairments limiting participation in physical activity and exercise following PCI
* Evaluated by their physician to be TOO HIGH RISK for moderate physical activity as proposed in this study
Reconstruction of Deficient Maxillary Ridges Using Retromolar Blocks With and Without Collagen Membrane

Is the use of collagen membrane on top of particulate bone mixture covered by onlay bone block in Maxilla better than the use of mixture of particulate bone covered by onlay bone block without the use of collagen membrane, in terms of bone quantity?

Soft tissue dehiscence could result due to flap irritation as a result of, closure under tension, intraoperative or postoperative recipient site infection, postoperative edema, which in turns compromises stability of onlay bone blocks thus osseintegration of bone block. Any attempt of bone recontouring and resuturing fails since there is no vascular bed. Ideal requirements of barrier membranes are, they should be biological compatible, they must act as a barrier membrane, unwanted fibroblasts should be hindered from entrance while allowing diffusion of nutrients, tissue integration (biological adhesion), tissues should be able to grow into the membrane but not through it. Space maintainer, it should be sufficiently stiff, so as not to collapse into the underlying particulate bone under the pressure of soft tissue and it should be ease in its manipulation, adaptation and handling, as for example, collagen membrane. Some types of collagen membrane, contain some degrees of stretchability example Geistlich Bio-Gide or Jason Membrane Botiss.

Eligibility Criteria:
Inclusion Criteria:

* Patients with maxillary residual alveolar bone height not less than 8 mm.
* Alveolar bone width from less than or equal 5 mm.
* Both genders.
* At least missing single tooth.
* Previous Failed Implants.
* Previous Failed Grafting.

Exclusion Criteria:

* • Heavy smokers more than 20 cigarettes per day.

  * Patients with alcohol abuse
  * Patients with narcotic abuse.
  * Patients with bone disease that may affect normal healing, example; hyperparathyroidism.
  * Patients had radiotherapy and chemotherapy in head and neck.
  * Patients had neoplasms in sites to be grafted.
  * Patients with Metabolic diseases uncontrolled diabetic patients, Glycated hemoglobin (Hb A1c) more than 7 mg\\dl.
  * Pregnant females.
  * Patients with Para functional habits, apprehensive and non-cooperative.
  * Bone pathology related to the site to be grafted.
  * Psychological problems, stress situation (socially or professionally), emotional instability, and unrealistic patients' expectations.
  * Intraoral soft and hard tissue pathology.
  * Systemic condition that contraindicate implant placement.
  * Under the age of 18 years.
PTM202 for the Treatment of Environmental Enteric Dysfunction (EED)

The purpose of this study is to assess the effectiveness of PTM202 in treating environmental enteric dysfunction.


Eligibility Criteria:
Inclusion Criteria:

* Aged 6 - 9 months old
* -1\> Weight-for-age Z score \> -3
* Parental consent to participate and receive daily supplementation with either PTM202 and/or micro-nutrient sprinkles, participate in specimen collection

Exclusion Criteria:

* Presence of known kidney, liver, heart, developmental, or neurologic disease
* Allergy to milk and/or egg (assessed by history)
* Milk intolerance (assessed by history)
* Abnormal liver or kidney function tests
* Family is planning to move from the study area or children is enrolled to the other clinical trial within 3 months of follow up
* Child being exclusively breast fed at the time of enrollment
LCD Solution Versus Calcipotriol Cream in the Treatment of Moderate Plaque Psoriasis

The purpose of this study is to compare the safety and effectiveness of a new topical LCD solution and a commercially available calcipotriol (Vitamin D) cream in reducing the symptoms of plaque psoriasis and improving the quality of life in adults.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* able and willing to provide written informed consent
* diagnosed with chronic plaque psoriasis
* 3% to 15% body surface area involved
* in good general health

Exclusion Criteria:

* other current treatments for psoriasis
* renal or liver dysfunction
* pregnant or nursing
The Effect of Sound Stimulation on Pure-tone Hearing Threshold

The purpose of this study is to investigate if sound stimulation could improve pure-tone hearing threshold.

In the late 1990s, researchers discovered that acoustic stimuli slow progressive sensorineural hearing loss and exposure to a moderately augmented acoustic environment can delay the loss of auditory function. In addition, prolonged exposure to an augmented acoustic environment could improve age-related auditory changes. These ameliorative effects were shown in several types of mouse strains, as long as the acoustic environment was provided prior to the occurrence of severe hearing loss.

In addition to delaying progressive hearing loss, acoustic stimuli could also protect hearing ability against damage by traumatic noise. In particular, a method called forward sound conditioning (i.e., prior exposure to moderate levels of sound) has been shown to reduce noise-induced hearing impairment in a number of mammalian species, including humans.

Interestingly, recent report has suggested that low-level sound conditioning also reduces free radical-induced damage to hair cells, increases antioxidant enzyme activity, and reduces Cox-2 expression in cochlea, and can enhance cochlear sensitivity. Specifically, increased cochlear sensitivity was observed when distortion product otoacoustic emissions (DPOAEs) and compound action potentials (CAPs) were measured.

In addition to forward sound conditioning, backward sound conditioning (i.e., the use of acoustic stimuli after exposure to a traumatic noise) has been shown to protect hearing ability against acoustic trauma and to prevent the cortical map reorganization induced by traumatic noise.

Based on the results of animal studies, the investigators conducted a human study in 2007 and observed that sound stimulation could improve hearing ability. On average, the pure-tone hearing threshold decreased by 8.91 dB after sound stimulation for 2 weeks. In that study, however, the investigators observed only the hearing threshold changes by sound stimulation.

To verify the previous ameliorative effect of sound stimulation, the investigators included a control period in this study.


Eligibility Criteria:
Inclusion Criteria:

* You are a male or female aged between 18 and 70 years
* You have 25\~70 dB HL hearing loss at any frequency above 1.5 kHz
* You are able to use an mp3 player
* You are able to read English

Exclusion Criteria:

* Under the medications that could cause hearing loss (such as gentamicin, aspirin, ibuprofen, or acetaminophen)
* Chronic disease that could affect hearing (such as diabetes or high blood pressure)
* Temporal hearing loss
* Hearing loss more than 75 dB HL at any frequency
* Ear infections, chronic middle ear disease or any abnormality of the ear canal or ear drum
* Hearing aid user
* Pregnant females
Prevalence of HIV and Tuberculosis in Masiphumelele Township, Cape Town, South Africa

The purpose of this study is to estimate the amount of HIV and tuberculosis (TB) infection in individuals 15 years and older in the Masiphumelele township of Cape Town, South Africa. Data collected in this study will be used to predict the effect of introducing anti-HIV therapy in this community.

TB is the most common opportunistic infection among HIV infected people, and is the most common cause of death in HIV infected people in Africa. The Masiphumelele township of Cape Town, South Africa, with its high rates of TB and HIV, is representative of many poor communities of Africa. Via random sampling, this study will assess the prevalence of HIV and TB infections in the Masiphumelele township. Knowledge gained from this study will be used to predict if introducing antiretroviral therapy will reduce the prevalence of TB in this community.

Selection and enrollment of participants will last about 4 months. Potential participants will be visited in their homes by fieldworkers, who will explain the study. Participants will be invited to either go to the clinic on the day of the fieldworker's visit or to go on a different day. Participants who go to the clinic on the day of the visit will have two sputum samples collected with a nebulizer. Participants who do not go to the clinic on the visit day will be given a sputum sample bottle and will be asked to collect a sputum sample in the early morning the day before their clinic appointment. At the clinic appointment, another sputum sample will be collected from these participants. Direct smear acid-fast bacilli and Mycobacterium tuberculosis cultures will be done on both sputum samples. Participants who test positive for TB will be referred for TB treatment at the clinic. Participants will also be asked to complete a study questionnaire and will undergo an anonymous oral HIV test at the clinic visit.

Eligibility Criteria:
Inclusion Criteria:

* Resident of the Masiphumelele township for at least 1 week prior to study entry
* Willing to provide informed consent
* Willing to comply with study requirements
Acceptability and Tolerance of New Oral Nutritional Supplement

To evaluate tolerance and acceptability of AYMES LONDON in patients requiring supplementary oral nutritional support compared with currently available alternatives.

TITLE EVALUATION OF TOLERANCE AND ACCEPTABILITY OF AYMES LONDON STUDY OBJECTIVES

* To evaluate tolerance and acceptability of AYMES LONDON in patients requiring supplementary oral nutritional support compared with currently available alternatives.
* To obtain data to support an ACBS submissions for AYMES LONDON (to allow for prescription in the community at NHS expense).

STUDY DESIGN Interventional study. STUDY POPULATION 20 patients established on an oral nutritional supplement (ONS), requiring nutritional supplementation of at least 300kcal/day. Patients residing in community settings (e.g. own home, care home or community hospital) STUDY PRODUCTS AYMES LONDON Patients' current oral nutritional supplements STUDY GROUPS This is an observational study where the patient will act as their own control, there will be just one study group containing all patients STUDY OUTLINE Baseline: After recruitment patients will remain on their current oral nutritional supplement for 3 days, during which time baseline tolerance data will be recorded (number and consistency of bowel movements, daily, volume of ONS taken, any episodes of nausea, vomiting, burping, abdominal pain, bloating or diarrhoea). A three-day food diary will be kept to record total oral intake. Patients will also have anthropometric measurements carried out during this period (weight, height, body mass index (BMI)).

Intervention Period : Patients will then be changed onto an equivalent prescription of AYMES LONDON for a period of 9 days. Tolerance data will be recorded daily but the first 2 days on AYMES LONDON will be considered a 'transitional' period and data from these days will not be analysed. A further 3-day food diary will be kept during the intervention period. Weight of the patient will be recorded at the end of the period on AYMES LONDON, and an acceptability questionnaire will be completed.

Comparisons will be made between baseline and the end of each phase of the study using appropriate analysis methods.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (≥18 years) who are able to communicate their views regarding acceptability.
* Patients established on an oral nutritional supplement, being prescribed 1-2 ONS providing at least 300kcal/day
* Patients expected to require oral nutritional supplementation for at least 2 further weeks.
* Informed consent obtained

Exclusion Criteria:

* Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study
* Patients requiring a milk free
* Patients with medical or dietary contraindication to any feed ingredients (see appendix 2 of protocol for full list)
* Patients with significant renal or hepatic impairment
* Patients with dysphagia requiring stage 1,2 or 3 thickened fluids
* Patients with uncontrolled inflammatory bowel disease or previous bowel resection with ongoing gastrointestinal symptoms.