cyrilzakka/clinical-trials huggingface dataset:
Long Term Effects of Weight Loss on Post-prandial Gut Hormone Responses and Meal Induced Thermogenesis

A study to examine post-prandial gut-hormone secretion, meal-induced thermogenesis, fasting plasma metabolomic/lipidomic and cardiovascular indices among surgically managed obese individuals in the long term compared to conservatively managed obese patients.

This is a protocol for the study of post-prandial gut peptide response and meal-induced thermogenesis in a group of 15 conservatively managed (through diet and exercise) morbidly obese individuals. During two separate visits in the study site, anthropometric and bioelectric impendence data will be collected, resting metabolic rate will be measured, and the patients will undergo a panel of cardiovascular examinations (heart rate variability, baroreflex sensitivity, heart ultrasound). On a separate occasion, they will consume a standardized test mixed meal and complete visual analog scales for the subjective assessment of hunger and fullness every 30 minutes for 3 hours. At the same time points, blood samples will be collected for the consequent measurement of glucose, insulin, lipids, and gastrointestinal hormones. Additionally, immediately before and at 60', 120', 180' after the start of the consumption of the test meal, the resting metabolic rate of each participant will be assessed through indirect calorimetry, to quantify meal-induced thermogenesis. The observed induction of satiety and suppression of hunger, post prandial gut-peptide mobilization and change in metabolic rate will be compared to those of participants of trial no NCT03851874 (Morbidly obese patients that have undergone either Roux en Y gastric bypass or sleeve gastrectomy and participated in trial NCT03851874). Participants in the aforementioned cohort have been already followed-up during the first postoperative year and will attend the study site for another follow-up visit approximately 10 years postoperatively, whereby the same diagnostic evaluation described above will take place. Data analysis will take place within the bariatric cohort (longitudinal analysis of the effects of surgery and surgery types on anthropometric parameters, fasting and postprandial glycemia and lipemia, fasting NMR-Metabolomic/Lipidomic profiles, Indices of insulin resistance, echocardiography, energy expenditure) as well as between the two groups in a cross-sectional manner.

Eligibility Criteria:
Inclusion Criteria:

* For the conservatively managed cohort:

  1. Morbid obesity based on BMI \> 40kg/m2, managed exclusively with conservative measures (hypocaloric diet and/or increased physical activity and/or behavioral therapy)
  2. Age between 18 and 65 years
* For the bariatric cohort: Participation in NCT03851874 trial

Exclusion Criteria:

1. Serious and life threatening comorbidities (renal, cardiac, liver failure, or malignancy)
2. Alcohol or other substance abuse
3. Use of licenced or off-label weight loss medications during the past 6 months
4. Concurrent psychiatric illness
5. Known history of diabetes mellitus (remitted cases excluded)
A Randomized Controlled Trial of an Antiretroviral Treatment Adherence Intervention for HIV+ African Americans

Project Rise is a randomized controlled trial (RCT) of an innovative, culturally congruent treatment education (TE) intervention for African Americans with HIV that targets cultural and social issues contributing to health disparities.

Project Rise is a randomized controlled trial (RCT) of an innovative, culturally congruent treatment education (TE) intervention for African Americans with HIV that targets cultural and social issues contributing to health disparities. TE facilitates patient navigation through the medical system and provides treatment education and client-centered counseling to improve adherence and retention in care. TE targets structural issues in healthcare and patients' lives by advocating to providers to improve patient-provider relationships, recommending changes in treatment and/or providers, and referring patients to mental health and social services.

A total of 350 Black participants will be recruited through APLA Health and randomly assigned to the intervention or usual care control group (175 per group). Adherence will be electronically monitored daily (and downloaded bi-monthly) from baseline to 13-months post-baseline. Viral load will be assessed through venipuncture at baseline and 6- and 13-months post-baseline. It is hypothesized that the intervention group will show better adherence and have a greater likelihood of suppressed viral load than the control group over time.

Eligibility Criteria:
Inclusion Criteria:

* HIV-positive
* 18 years of age or older
* Self-identified as African American/Black
* Been prescribed antiretroviral therapy (ART) in the past 12 months
* Self-reported adherence problems (i.e. missed at least 1 ART dose in the past month) and/or detectable viral load
* Willing to use Medication Events Monitoring System (MEMS) for electronic adherence monitoring.

Exclusion Criteria:

* HIV-negative
* 17 years of age or younger
* Not self-identified as African American/Black, not on antiretroviral therapy (ART) or not prescribed ART therapy in the last than 12 months
* No self-reported adherence problems and/or no detectable viral load
* Not willing to use Medication Events Monitoring System (MEMS) for electronic adherence monitoring.
Evaluate the Effects of Patupilone on the Pharmacokinetics of Midazolam and Omeprazole in Patients With Advanced Malignancies

The purpose of this study is to evaluate the potential inhibitory effects of patupilone on metabolism using midazolam and omeprazole as the respective probe drugs.


Eligibility Criteria:
Inclusion criteria:

* Male or female patients 18 years or older
* Histologically documented advanced solid tumor, who have failed standard systemic therapy, or for whom standard systemic therapy does not exist
* Life expectancy of 3 months or more
* Patients with adequate hematologic parameters

Exclusion criteria:

* Hypersensitivity to midazolam or omeprazole or related compounds
* Female patients who are pregnant or breast-feeding.
* Patients with a severe and/or uncontrolled medical disease
* Patients with a known diagnosis of human immunodeficiency virus (HIV) infection
* Patients having received an investigational agent within 30 days prior to study entry

Other protocol defined inclusion/exclusion criteria may apply.
Tranexamic Acid in Debridement Surgery of Burns on the Volume of Bleeding in Transfusion Requirements

Tranexamic acid in debridement surgery of burns on the volume of bleeding in transfusion requirements

A randomized, double-blind, prospective trial was conducted to establish the effect of intraoperative tranexamic acid in the early surgical debridement of severe burns. The study was carried out between the months of January 2022 and December 2023.

Eligibility Criteria:
Inclusion Criteria:

1. First-time patients undergo surgical debridement of their burns.
2. A burn percentage of 10-30% of burned body surface area
3. Patients over 18 years of age
4. Patients under 40
5. IMSS beneficiaries

Exclusion Criteria:

1. Burned patients with previous surgical debridement.
2. Patients with co-morbids.
3. Patients with a history of drug hypersensitivity.
4. Patients with kidney disease.
Long-term Retinal Changes After Topical Citicoline Administration in Patients With Mild Signs of Diabetic Retinopathy in Type 1 Diabetes Mellitus.

Citicoline (cytidine-5'-diphosphocholine) is an essential precursor in the synthesis of phosphatidylcholine, a component of cell membranes. Several experimental in vitro and in vivo studies have suggested that citicoline plays a neuroprotective role.

A recent clinical study has shown that treatment with topical citicoline induces, after 60 days of therapy, a significant improvement in the ganglion cell function .In addition topical citicoline has been demonstrated in vivo a neuroprotective effect in preventing diabetic retinopathy .

The Investigators want to evaluate if citicoline may reduce the progression of retinal damage in patients with mild diabetic retinopathy.

The investigators evaluated patients with mild signs of diabetic retinopathy (DR) treated with eye-drop solution with citicoline ( OMk2 ophthalmic solution).

All patients was randomized in two groups (10:10), one receiving topical administration of OMk2 ophthalmic solution for 36 months and one group receiving only the excipients of OMk2 (placebo).

Omk2 ophthalmic solution and the placebo will be used for 36 months three times/day.

They will undergo a complete ocular examination at baseline and at 6-, 12-, 18-, 24-, 30- and 36- months after treatment.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of type 1 DM
* Diagnosis of mild Diabetic rethnopathy (DR)
* Retinal sensitivity impairment evaluated by means of frequency doubling technology (Matrix FDT) with a mean deviation (MD) p value \<5% or with two locations with p \<5% and one location with p\<1% in the total or pattern deviation plots.

Exclusion Criteria:

* Hyperopia higher than +5 diopter (D)
* myopia higher than -8 D
* astigmatism higher than 2 D
* Visual acuity below 20/25
* significant media opacity
* previous ocular surgery
* previous diagnosis of glaucoma
* uveitis
* retinal disease other than mild diabetic retinopathy
* patients with any ocular disease
* systemic disease other than diabetes
* Any signs of diabetic retinopathy more advanced than mild as coded by ICDRSS (e.g. macular edema or any sign of proliferative DR)
A Study of Crofelemer to Treat Diarrhea Irritable Bowel Syndrome

This study is designed to evaluate the safety and effectiveness of an investigational drug, TRN-002 (crofelemer) to relieve the symptoms of diarrhea-predominant irritable bowel syndrome (IBS).

The investigational drug is a natural product taken from a plant that grows in South America. The study medication will be administered orally twice a day. Subjects who are eligible to participate will have a 75% chance of receiving TRN-002 and a 25% chance of receiving placebo (a substance that looks similar to TRN 002 but has no activity). Subjects will not be able to remain on certain standard IBS medications (antidiarrheals) while participating in the study. The total duration is 16 weeks.

The study requires five study visits that include physical exams, ECG and blood draws for laboratory studies. A colon procedure (such as a colonoscopy or flexible sigmoidoscopy) may also be required if it has not been performed since your diagnosis and within the last 5 years. Participants will be asked to make daily entries into a touch-tone telephone diary on a daily basis.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of diarrhea predominant Irritable Bowel Syndrome
* Willingness to make daily calls on a touch-tone telephone
* Willingness to have an endoscopic and/or radiologic bowel evaluation, if you have not received one since your IBS diagnosis and in the past 5 years
* Willingness to use an approved method of birth control

Exclusion Criteria:

* Serious medical or surgical conditions
* Gastrointestinal Cancers, Crohns Disease or Ulcerative Colitis
* Pregnancy or breast feeding
Investigation of Ultrasound Elastographic Techniques in Soft Tissue Pathology

Ultrasound (US)tissue elastography has recently been found to have a number of clinical applications in the assessment of soft tissue disease for example, in breast and thyroid pathology. There are few current studies exploring its use in musculoskeletal pathology, particularly a new technique called sheer wave ultrasound elastography (SWUE).

Magnetic Resonance (MR) elastography has shown wide reaching applications in orthopaedics, sports medicine and rheumatology and SWUE may have the potential to also demonstrate clinical effectiveness in these areas.

Our aim is to explore the effectiveness of this technique in the assessment of musculoskeletal pathology.

Participants will be recruited through current referral protocols and would undergo an additional elastographic investigation in addition to their standard US examination. This investigation will be conducted within the musculoskeletal US department at Chapel Allerton Hospital by trained musculoskeletal specialists. The study will be conducted over a period of approximately 24 months with quarterly review during this time.


Eligibility Criteria:
Inclusion Criteria:

* Have clinical symptoms and signs of soft tissue pathology
* Be able to give consent
* Be over 16 years of age

Exclusion Criteria:

* Unable to give consent
* 16years of age or less
* Multifactorial soft tissue pathology
Clinical Comparison of Two Daily Disposable Toric Soft Contact Lenses

The primary purpose of this study is to demonstrate noninferiority in the visual acuity at distance when wearing PRECISION1™ for Astigmatism (P1fA) soft contact lenses compared to another commercially available, soft toric contact lens, MyDay® toric (MDT).

Study participants will wear each study lens type in 1 of 2 randomized, crossover sequences. Participants will be expected to attend 4 visits and wear study lenses for at least 10 hours per day. The total duration of an individual's participation in the study will be up to 28 days.

Eligibility Criteria:
Key Inclusion Criteria:

* Successful wearers of toric soft contact lenses in both eyes with at least 3 months wearing experience, with a minimum wearing time of 5 days per week and 10 hours per day.
* Able to wear contact lenses within a range of sphere \& cylinder power and axes.
* Willing to NOT use rewetting/lubricating drops at any time during the study.
* Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

* Current or previous P1fA and MDT habitual lens wearers.
* Monovision and multifocal lens wearers.
* Participation of the subject in a clinical trial within the previous 30 days or currently enrolled in any clinical trial.
* Other protocol-defined exclusion criteria may apply.
A Trial Investigating Lu AF82422 in Healthy Chinese and Caucasian Adults

The main goals of this trial are to learn more about a) the safety and tolerability of Lu AF82422 (any new or worsening medical issues the participants have with treatment), b) the immunogenicity of Lu AF82422 (the potential for the drug to trigger an unwanted immune response), and c) the pharmacokinetic parameters of Lu AF82422 (how the drug is absorbed, distributed, and processed by the body). During the trial, healthy adult Chinese and Caucasian participants will receive a single dose of Lu AF82422, which will be given as an intravenous infusion.


Eligibility Criteria:
Inclusion Criteria:

* For Chinese participants only: The participant is Chinese, defined as having four Chinese grandparents.
* For Caucasian participants only: The participant is Caucasian, defined as having four Caucasian grandparents.
* The participant has a Body Mass Index (BMI) ≥19 and ≤26 kilograms per square meter (kg/m2) at the Screening Visit and at the Baseline Visit.
* The participant is, in the opinion of the investigator, generally healthy based on medical history, a physical examination, a neurological examination, vital signs, an electrocardiogram (ECG), and the results of the clinical chemistry, haematology, urinalysis, serology, and other laboratory tests.

Exclusion Criteria:

* The participant has previously been enrolled in this trial.
* The participant has previously been dosed with Lu AF82422.
* The participant has participated in a clinical trial \<30 days prior to the Screening Visit.
* The participant has taken any investigational medicinal product \<3 months or \<5 half-lives of that product, whichever is longer, prior to administration of the IMP.
* The participant is pregnant, breastfeeding, intends to become pregnant, or is of childbearing potential and not willing to use adequate contraceptive methods.

Other protocol-defined criteria apply.
Intravenous Silibinin in Combination With Peg-interferon and Ribavirin in Nonresponders

By chance the investigators found that iv. silibinin has a potent antiviral effect against the hepatitis C virus. Based on the results of the dose finding study (published) te optima dosing schedule is explored.This study will be evaluate whether the highest active dose given for the optimal time combined with standard of care will result in a sustained virologic response (=cure of hepatitis C).

Since the publication of the first data the optimal dosing schedule is investigated

Eligibility Criteria:
Inclusion Criteria:

* Nonresponders to full dose PEG-IFN/RBV therapy
* Liver biopsy within the last 2 year

Exclusion Criteria:

* Intolerance to one of the study drugs
* Coinfection with HIV/HBV
Postoperative Pain and Analgesic Requirements After Preoperative Methadone for Primary TKA

The goal of this prospective, randomized study is to compare the outcomes of two cohorts of patients undergoing primary Total Knee Arthroplasty (TKA) and to determine whether a single dose of methadone administered preoperatively is effective at reducing postoperative opioid usage and postoperative pain versus a control group of patients receiving standard intraoperative opioids only for primary TKA.

The main questions it aims to answer are:

* What is the efficacy of a single preoperative dose of methadone in reducing opioid consumption and postoperative pain in primary total knee arthroplasty?
* Will the study results demonstrate the effectiveness and safety of a single preoperative dose of methadone (10 mg) in primary total knee arthroplasty in reducing postoperative opioid usage while maintaining a similar or better level of pain control when compared to a standard pain control regimen? Researchers will compare Methadone to a standard pain control regimen (Oxycodone) to see if Methadone is equivalent or more effective at reducing opioid consumption and postoperative pain in primary total knee arthroplasty

Participants will:

* be randomized into one of two groups
* undergo a primary TKA
* complete a tracking sheet documenting daily pain medicine usage and VAS pain level for the first 14 days following the TKA
* return to office at 2 weeks and 6 weeks postop for follow-up
* complete additional questionnaires at 2 weeks and 6 weeks postop


Eligibility Criteria:
Inclusion Criteria:

1. Patient age is 21-89 at time of surgery
2. Patient is scheduled to undergo a unilateral primary TKA, secondary to osteoarthritis
3. Patient agrees to participate as a study subject and signs the Informed Consent and Research Authorization document
4. Patient is able to read and speak English.

Exclusion Criteria:

1. Patient is under the age of 21
2. Patient's primary diagnosis is not osteoarthritis
3. Patient is unable to read and speak English
4. History of liver or kidney disease,
5. Known or suspected GI obstruction
6. Hypersensitivity to methadone
7. Patients with significant respiratory depression
8. Pregnant or nursing females
Safety of Skin Cleansing With Chlorhexidine in Preterm Low Birth Weight Infants

The purpose of this study is to examine if single skin cleansing with 0.25% chlorhexidine affects skin condition, temperature, and bacterial colonization in stable preterm (28-36 weeks gestational age) low birth weight (1001-2000 g) infants admitted in a health facility.

Infections are the leading cause of death in neonates admitted to hospital - studies from developing countries suggest that about 25-71% of deaths occurring in neonatal intensive care units are secondary to infections.Such high infection-related mortality mandates an urgent implementation of simple and effective measures to prevent the occurrence of infections in these units.

The majority of neonatal infections occur in the first two weeks of life, when the epidermal barrier is immature and functionally compromised. Topical application of antiseptics until the skin matures could theoretically prevent skin colonization and reduce the incidence of systemic infections in neonates. Chlorhexidine, a broad-spectrum antiseptic used frequently for umbilical cord care in neonates, is now being evaluated for topical application to the skin. Hospital-based studies, involving predominantly term infants, have shown reductions in skin flora8 and a reduction in the incidence of sepsis following topical chlorhexidine application. In a community-based study in Nepal, a single skin cleansing with 0.25% chlorhexidine resulted in reduction in mortality among low birth weight infants; though the mechanism of the impact could not be determined, it was presumably due to increased susceptibility to transcutaneous sepsis in the low birth weight group.

Since the risk of infection in neonates is inversely related to their gestation, it is essential to evaluate the effect and the mechanism of such intervention in preterm neonates. These infants are, however, more prone to develop skin reactions following use of topical antiseptics. Preterm infants are also more prone to develop hypothermia following bathing/cleansing with antiseptic solution(s).

Since few studies have evaluated the effects of topical application of chlorhexidine in preterm infants admitted in a health care facility, we conducted the present study to examine if single skin cleansing with 0.25% chlorhexidine immediately after birth affects skin condition, temperature, and colonization in hospitalized preterm low birth weight infants.

Eligibility Criteria:
Inclusion Criteria:

* Preterm infants of 28 to 36 weeks' gestation
* Birth weights between 1001 and 2000 g

Exclusion Criteria:

* Infants with one minute Apgar score \< 4
* Hemodynamic instability
* Congenital malformations
* Generalized skin disorder and
* Infants who need respiratory support (continuous positive airway pressure and/or intermittent mandatory ventilation) in the first 2-3 hours of life
CHAT at HOME Pilot Study

This study is evaluating the acceptability and feasibility of a 10 session parent-targeted phone-based childhood obesity treatment (n=40). A factorial design (2 X 2 X 2) will be used to examine the acceptability and feasibility of 3 intervention components: 1) the first session being conducted in person, 2) involving a second adult caregiver, and 3) a weekly weighing of child via WiFi-enabled scales.

All participants in this study will receive 10 core coaching sessions. These sessions will be conducted between study staff and parents of children ages 8 - 12 who are in the 85th percentile or higher on the BMI scale. The sessions will focus on healthy habits and positive reinforcement for behavior changes within the house that could lead to a reduction in the the child's BMI. In addition to the 10 core sessions, some participants will have difference components of the intervention added to their treatment: conducting the first session in-person, having a second caregiver participate in some of the coaching calls, and/or having the child use a wifi-enabled scale for weekly weigh-ins.

Eligibility Criteria:
Inclusion Criteria:

* Parent/primary caregiver of child in the 8-12 year old age range based on child birth date
* The child's BMI is greater than or equal to the 85th percentile according to CDC age and sex reference standards
* Child lives with parent/primary caregiver 50% of the time
* Willing to have a second caregiver participate in this study
* Wifi at home
* The parent and child can speak, read, and understand English

Exclusion Criteria:

* Kidney disease, Type 1 diabetes, Lupus, current Cancer diagnosis,
* Chromosomal abnormality such as Down's syndrome or Turner's syndrome
* Child taken any steroid medications such as Prednisone, Prenisilone and Decadron on a daily basis for more than 1 month in the past 6 months (this does not include inhalers with steroids)
* Child enrolled in a different weight management program
* Family participating in any other child research study related to dietary intake, physical activity, weight
* Plans to move more than 50 miles from your present location within the next 6 months