cyrilzakka/clinical-trials huggingface dataset:
Impact of SBI, a Medical Food, on Nutritional Status in Patients With HIV-associated Enteropathy

The purpose of the study is to evaluate the effectiveness of the oral nutritional therapy serum-derived bovine immunoglobulin protein isolate (SBI) 2.5 g twice a day (BID) and SBI 5.0 g versus placebo on supporting nutrient absorption in HIV+ subjects with HIV-associated enteropathy.

This study is evaluating the effectiveness of the oral nutritional therapy serum-derived bovine immunoglobulin protein isolate (SBI) 2.5g BID and SBI 5.0g compared to placebo for 6 months on gastrointestinal symptoms, nutritional status and quality of life in HIV+ subjects with HIV-associated enteropathy. In addition, the effects of SBI on pro-inflammatory intestinal microbial populations, bacterial translocation, intestinal barrier function, and systemic immune activation will be investigated.

Eligibility Criteria:
Inclusion Criteria:

* History of HIV-1 infection
* Plasma HIV viral load ≤40 copies/mL
* Maintained virologic suppression for 1 year
* Stable Antiretroviral Therapy (ART) regimen
* History of HIV-associated diarrhea defined as abnormal passage of 3 or more unformed stools per day or a liquid stool volume greater than 200 g per day for at least 4 weeks duration

Exclusion Criteria:

* Positive stool test for pathogenic bacteria, C. difficile or ova and parasites
* Conditions that require chronic therapy that is known to alter gut microbiota
* Antibiotics within 2 weeks of screening (exception: prophylaxis antibiotics)
Oral Health Promotion Program in Schools in Polígono Sur

The objective of this observational study is to evaluate oral health before and after conducting an educational session on oral hygiene in schoolchildren from 3 schools in the Polígono Sur of Seville.

The main questions it aims to answer are:

* To find out the needs of schoolchildren for oral treatment.
* To analyse whether the educational sessions carried out serve to improve the oral health of schoolchildren.

The researchers will compare the results of different academic years to see if it serves to improve.

The participants are examined at the school during the school year. The educational sessions are carried out at the school during the school year.


Eligibility Criteria:
Inclusion Criteria:

* Schoolchildren whose legal guardians agree to participate

Exclusion Criteria:

* Schoolchildren whose legal guardians do not consent to participate
Clinical Implications of DNA Analysis on ADPKD

Autosomal dominant polycystic kidney disease (ADPKD) is an inherited disease. We plan DNA analysis using the next generation sequencer (NGS) and examine the relationship between mutational types and clinical phenotypes. The accuracy of DNA analysis with NGS is tested by Sanger's method. The kidney and life survival curves will be compared between PKD1, PKD2 and non-ADPKD family members.

80 unrelated patients with ADPKD attending to the Kyorin University Hospital whose clinical data are compiled. DNA analysis is performed at Otsuka Pharmaceutical Laboratory.

Clinical data include total kidney volume (TKV), TKV slope, eGFR, eGFR slope and other clinically relevant data.

Eligibility Criteria:
Inclusion Criteria:

* The unrelated patients with ADPKD.

Exclusion Criteria:

* The patients whose clinical data are not compiled.
HOBSCOTCH Phase III

The purpose of this study is to determine the efficacy of an entirely virtual version of the home-based cognitive self-management program "HOBSCOTCH." It will test whether HOBSCOTCH can be delivered nationally from a distance utilizing e-health tools (telephone, computer, and phone).

HOBSCOTCH (Home Based Self-management and Cognitive Training Changes lives) is a home-based self-management program to treat cognitive symptoms and improve quality of life, while minimizing the barriers of access to care. The program is based on Problem Solving Therapy (PST) and teaches problem solving strategies and compensatory mechanisms to help manage cognitive dysfunction and enhance quality of life.

HOBSCOTCH Phase III is a study to examine an entirely virtual version of the program. While HOBSCOTCH was shown to be effective as an in-person and telephone-based program in previous trials (HOBSCOTCH Phase I and II), this study aims to test a version of the program adapted for entirely virtual delivery. This is a single-center study, with the HOBSCOTCH intervention being delivered by staff affiliated with Dartmouth-Hitchcock Medical Center in Lebanon, NH.

Eligibility Criteria:
Inclusion Criteria:

* Age 18+
* Diagnosis of epilepsy, with controlled or uncontrolled seizures
* Subjective memory complaints
* No changes in antiepileptic and antidepressant medication regimen for 1 month, however brief discontinuation of antiepileptic medicine for inpatient video EEG evaluation is acceptable
* Literate
* Telephone access
* Internet access

Exclusion Criteria:

* Subjects self-reporting a dementing illness or a mention of a dementing illness in their medical record
* Severe mental disability or estimated IQ less than 70 per clinical judgement
* Significant visual impairment precluding reading or writing
* No reliable telephone or internet access
* No diagnosis of epilepsy
A Clinical Study to Evaluate the Long-term Safety (12 Months) of the Combination of Aliskiren 300 mg and Hydrochlorothiazide 25 mg

The purpose of this study is to collect the long-term (12 months) safety data on aliskiren 300 mg when taken in combination with HCTZ 25 mg.


Eligibility Criteria:
Inclusion Criteria:

1. their successful completion of the CSPP100A2302 core study with at least eight months combination treatment of aliskiren 300 mg and HCTZ 25 mg, i.e., patients who received aliskiren 300 mg and HCTZ 25 mg at Month 4 of the core study and complete the core study.
2. absence of ongoing severe adverse events at Visit 10.
Dobutamine for Management of Surgical Patients with Septic Shock

Septic shock is the last and most severe stage of sepsis and is defined by extremely low blood pressure, despite lots of intravenous fluids. The incidence of septic shock related cardiomyopathy was 10% to 70%. Besides, general anesthesia will inhibit the sympathetic nervous system, reduce myocardial contractility and aggravate cardiac dysfunction. No randomized controlled trials have yet explore the effects of dobutamine on clinical outcomes for patients with septic shock undergoing surgery under general anesthesia.

Sepsis, defined as life-threatening organ dysfunction, is caused by a dysregulated host response to infection, which 30-day mortality rate is about 24.4%. Septic shock is the last and most severe stage of sepsis and is defined by extremely low blood pressure, despite lots of intravenous fluids.

Surgical patients with septic shock are not rare. The incidence of septic shock related cardiomyopathy was 10% to 70%. Besides, general anesthesia will inhibit the sympathetic nervous system, reduce myocardial contractility and aggravate cardiac dysfunction, furthermore exacerbate hemodynamic instability, and then increase the incidence of AKI and patient mortality. Therefore, to improve cardiac function in patients with septic shock who received general anesthesia is the key to save patients life and improve prognosis.

The latest international guidelines for the treatment of septic shock recommend - in patients with septic shock combined with cardiac dysfunction, treatment with norepinephrine in combination with dobutamine is recommended if inadequate tissue perfusion persists after adequate fluid resuscitation and maintenance of blood pressure, but the level of evidence is weak.

Dobutamine acts on β-adrenergic receptors, which can improve tissue perfusion, and small doses of 2.5-5ug/kg/min can increase myocardial contractility and improve cardiac function in patients without increasing heart rate. Previous study has demonstrated that the combined use of norepinephrine and dobutamine can elevate left ventricular ejection fraction, cardiac index, improve tissue perfusion, and reduce mortality in patients with septic shock. No randomized controlled trials have yet explore the effects of dobutamine on clinical outcomes for patients with septic shock undergoing surgery under general anesthesia.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with 18 years or older
2. Sugery patients with septic shock and the duration of opration is more than 1 hour

Exclusion Criteria:

1. Pregnancy;
2. Long-term intakeβ-receptor blocker;
3. patietns with dobutamine used within 72h before enrollment;
4. Patients use Recombinant Human Brain Natriuretic Peptide(rhBNP), Levosimendan and Epinephrine within 72h before enrollment;
5. Patients with hyperthyroidism;
6. Allergy or known sensitivity to catecholamines（norepinephrine, dobutamine etc.）and genera anesthetics.
7. Patients and guardians refused to participate in this intervention clinical trial.
Topical Analgesic Versus Saline Mouth Rinses in Post Extraction Healing

There is no evidence based guidelines on using saline rinses for post extraction oral care among hypertensives. Similarly, benefit of orally dissolved topical analgesics in addition to orally administered analgesic is questionable.

Objective: To compare the post dental extraction healing among subjects who took simple analgesic tablets dissolved in water versus those who used saline rinses post operatively.

Methods: A study will be done among patients who underwent dental extractions at AKHSP dental clinic, Karachi, Pakistan. Carious, periodontally mobile, traumatized or broken down teeth among 20-70 years old in either gender will be included.

In addition to the routine prescription of antibiotics and oral analgesics, the hypertensive subjects (n=20) will be advised to take dissolved Aspirin tablet as an oral care while non-hypertensive will be divided into two sub groups (n=20 each), advised saline mouth rinses or dissolved Aspirin for 5 days, respectively.

The outcome (healing of the extraction socket) will be evaluated 7 days from the day of extraction on an ordinal scale.

Eligibility Criteria:
Inclusion Criteria:

* Carious, periodontally mobile, traumatized or broken down teeth needing extraction
* Age 20-70 years, both genders

Exclusion Criteria:

* Diabetes
* Osteoporosis, metabolic bone disease etc.
* Radiation therapy or chemotherapy.
MEN-10755 in Treating Adults With Recurrent or Refractory Solid Tumors

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of MEN-10755 in treating adults who have recurrent or refractory solid tumors.

OBJECTIVES: I. Determine the maximum tolerated dose (MTD) of MEN-10755 in patients with recurrent or refractory adult solid tumors. II. Determine the qualitative and quantitative toxic effects of MEN-10755 and study the predictability, duration, intensity, onset, reversibility, and dose relationship of the toxic effects in these patients. III. Propose a safe dose for phase II study. IV. Assess the pharmacokinetics of MEN-10755 at different dose levels in these patients. V. Document any possible antitumor activity of MEN-10755.

OUTLINE: This is an open label, nonrandomized study. Patients receive MEN-10755 as a single 15 minute intravenous infusion every 3 weeks, or upon recovery from toxicity. Doses will be escalated in decreasing rates and depending on the clinical judgement of the investigator. The MTD is the dose at which dose limiting toxicity is observed in at least 2 of 6 patients at a given dose level. Patients will be removed from the study if cardiac toxicity, disease progression, or renal, cardiac or pulmonary decline is present.

PROJECTED ACCRUAL: At least 5 evaluable patients will be enrolled.

Eligibility Criteria:
DISEASE CHARACTERISTICS: See General Eligibility Criteria

PATIENT CHARACTERISTICS: Age: 18 and over Performance Status: WHO 0-2 Life Expectancy: At least 3 months Hematopoietic: ANC at least 2,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL Liver function tests no greater than 2 times upper limit of normal (ULN) (unless related to liver metastases, then no greater than 5 times ULN) Renal: Creatinine no greater than 1.4 mg/dL Creatinine clearance at least 60 mL/min Cardiovascular: LVEF greater than 50% (measured by MUGA scan) Other: Not pregnant or nursing Effective contraceptive method must be used during study No active bacterial infections No other nonmaliganant diseases No history of alcoholism or drug abuse No psychosis

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior immunotherapy within 4 weeks of study Concurrent use of growth factors is allowed in cases of febrile neutropenia (prophylactic use not allowed) Chemotherapy: No prior chemotherapy within 4 weeks of study No prior nitrosoureas, mitomycin, or high dose carboplatin within 6 weeks of study Endocrine therapy: No concurrent corticosteroids (unless approved by clinical investigator) Radiotherapy: No prior radiotherapy within 4 weeks of study No prior extensive radiotherapy within 6 weeks of study Surgery: Not specified Other: No prior experimental therapy No prior anthracyclines or anthracenediones
Investigation of Effectiveness of Telerehabilitation for Zone 2 Flexor Tendon Injuries of the Hand

The treatment process following Zone 2 flexor tendon injuries, which are particularly controversial for hand surgery, is challenging. There are various rehabilitation methods for Zone 2 flexor tendon injuries, one of which is the Modified Duran Protocol. Disruptions in the physiotherapy process lead to joint contractures, tendon adhesions, and limitations in daily life activities for patients. Due to global issues such as socioeconomic factors, physical barriers, distance, and pandemics, patients who cannot actively participate in physiotherapy miss out on the rehabilitation process.

The aim of the present study is to investigate the effectiveness of the Modified Duran protocol applied through telerehabilitation following Zone 2 flexor tendon repair. Between April and October 2024, a total of 42 adults aged 18-55 who underwent Zone 2 flexor tendon repair at Istanbul University Istanbul Faculty of Medicine will be recruited, with 21 participants in face-to-face clinic group and 21 in telerehabilitation group. Rehabilitation process will be followed for 12 weeks. The telerehabilitation group will receive exercise training on the third day. After the first training session, patients will be discharged and called to the clinic once a week for dressing changes, monitoring, exercises and if necessary, revision of the protective splint. Patients will be contacted three times a week to implement the planned program using telerehabilitation.

The face-to-face rehabilitation group will receive face-to-face clinic rehabilitation three times a week under the supervision of a physiotherapist for the first 12 weeks.

Patients will be evaluated at the end of the 5th, 6th, and 12th weeks. Data collection tools will include a 'Sociodemographic Form', 'Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire', 'Visual Analog Scale (VAS)', 'Jamar Hand Dynamometer', and 'Goniometer (Joint Range of Motion)'.

SPSS (Statistical Package for the Social Sciences) Statistics will be used for the statistical analysis of all data, with a significance level of p \<0.05 considered significant in all assessments, and accepted as two-tailed.


Eligibility Criteria:
Inclusion Criteria:

* Individuals with isolated Zone 2 flexor digitorum profundus (FDP) and flexor digitorum superficialis (FDS) injuries,
* Repair performed within the first 72 hours post-injury,
* Individuals aged between 18 and 55 years,
* Patients willing to participate in the study,
* Ability to attend sessions regularly.

Exclusion Criteria:

* Fingers with concomitant fractures, digital nerve injuries, vascular injuries, or significant skin loss accompanying flexor tendon injuries,
* Bilateral flexor tendon injuries,
* Patients with replantation or revascularization,
* Flexor Pollicis Longus tendon injuries of the thumb due to differences in protocols applied and measurement of final outcomes,
* Patients unable to understand and perform postoperative exercises
An Evaluation of Cultured Milk Drink on Immune Status of Patients With Irritable Bowel Syndrome: Constipation Predominant

Our previous work on the use of probiotics improved the clinical symptoms in irritable bowel syndrome with constipation-predominant. This study would like to explore further use of probiotics in the immune system of the patients with irritable bowel syndrome.

This is a case control study involving participants who fulfilled the Rome III criteria for constipation-predominant irritable bowel syndrome. The patients were recruited from the Gastroenterology clinic at Universiti Kebangsaan Malaysia Medical Centre, Kuala Lumpur. A total of 165 participants were recruited based on probability (power) of 0.8 and Type I error was set at 0.05.

The investigators included healthy participants above 18 years old. Those less than 18 years old; constipation due to other medical illnesses such as diabetes mellitus, inflammatory bowel disease, hypothyroidism, colorectal cancer, neurological diseases, major depression, lactose intolerance, pregnancy, breastfeeding women and must not be on chronic opioids or anti- depressants were excluded. Participants must not consume any antibiotics, probiotic, prebiotic, symbiotic and/or laxatives less than two weeks before recruitment.

Participants were required to consume three bottles of 125 ml cultured milk drink daily for 30 days. Each bottle contains 10\^9 cfu Lactobacillus acidophilus LA-5 and Lactobacillus paracasei L. CASEI-01. In each 100 ml unit, it contains 4.06 g of fructose, 4.14 g of glucose, 0.29 g of sucrose, less than 0.1 g of maltose and 1.35 g of lactose. Cold chain was maintained below 10°C during storage, transportation and distribution. Prior to consumption of the cultured milk drinks, fecal and blood samples from the participants were obtained to determine their baseline fecal pH and serum cytokines level respectively. Each of the participants answered a food frequency questionnaire to assess their dietary profile (data are not presented in this paper) and the Garrigues Questionnaire to evaluate their clinical symptoms and physical activity. The same parameters were taken following 30 days of cultured milk drinks' consumption.

Eligibility Criteria:
Inclusion Criteria:

* Do not fulfil the Rome III criteria for irritable bowel syndrome

Exclusion Criteria:

* constipation due to other medical illnesses such as diabetes mellitus, inflammatory bowel disease, hypothyroidism, colorectal cancer, neurological diseases, major depression, lactose intolerance, pregnancy, breastfeeding women and must not be on chronic opioids or anti- depressants. Participants must not consume any antibiotics, probiotic, prebiotic, symbiotic and/or laxatives less than two weeks before recruitment.
Brand Level Nutrient Information Compared to Generic Food Codes

Measuring diet is difficult. This is the first time that brand level foods and nutrient values have been compared with generic food codes to explore the difference this might make to estimated nutrient intakes.

Background Traditional dietary assessment methods lack precision. myfood24 is an online 24-hour dietary assessment tool, aiming to reduce the burden of dietary assessment; providing data entry by participants using automated coding of food items. myfood24 includes a large branded food database.

Objective To assess the effect of using brand level nutrient information compared to generic food codes on estimated nutrient intakes.

Design A 24 hour recall was collected using myfood24, which contains a food and nutrient database of over 40,000 items with both branded and generic foods. Participants freely selected their foods generating the 'free choice recall'. After the online recall was completed, they provided further details of brands consumed. The free choice recalls were recoded forming an 'all branded' and an 'all generic' recall. Estimated nutrient intakes from the three different methods of food coding were compared to assess the impact of brand-level information.

Eligibility Criteria:
Inclusion Criteria:

* students University of Leeds
* convenience sample of general public
* adults

Exclusion Criteria:

* none defined
Statin Therapy for Ischemic and Nonischemic Cardiomyopathy

The purpose of this study is to see if taking a cholesterol lowering drug Lipitor (Atorvastatin Calcium)will increase the number of endothelial progenitor cells (EPC's) circulating in the blood of heart failure patients taking this cholesterol-lowering drug, and if this will also show an improvement in the damaged areas of the patient's hearts as documented by MRI scans.

This study involves the testing of blood for cholesterol levels and flow cytometry tests to count the number of EPC's in your blood. These tests are routinely performed to gain knowledge about a person's health. If any incidental findings are identified as a result of your participation in this research study, you will be notified and referred to your doctor or appropriate health care professional.

You are being asked to provide a blood sample that will be used to determine the usual numbers of EPC's circulating in the blood of healthy people who have no risk factors for heart disease. Your results will be compared with those of patients who have heart failure.

Flow cytometry is a special laboratory test that can count, separate, and detect characteristics of cells in blood. Your blood sample will be analyzed using flow cytometry. Endothelial progenitor cells (EPC's) are immature cells that are necessary for new blood vessel formation. EPC's will be separated by flow cytometry and counted. You will not be given the results of your flow cytometry study.

Eligibility Criteria:
Inclusion Criteria:

* Ischemic Cardiomyopathy (as defined above) with ejection fraction \< 35%
* Non-ischemic Cardiomyopathy with ejection fraction \< 35%
* NCEP ATPIII indication for therapy with a statin drug
* No statin therapy within previous 6 months of study enrollment
* Prescribed stable doses of standard heart failure therapies including beta blocking agents, angiotensin converting enzyme inhibitors or angiotensin receptor blockers, and diuretic agents as required

Exclusion Criteria:

* Pregnant or lactating
* Myocardial infarction within 6 months preceding study enrollment
* Primary valvular heart disease
* Surgical or catheter based revascularization within the preceding 6 months
* Documented viral or inflammatory myocarditis or cardiomyopathy
* Peripartum cardiomyopathy
* Infiltrative cardiomyopathies
* Chemotherapy associated cardiomyopathy
* Without indication for statin therapy
* Contraindication to statin therapy including hepatic dysfunction, history of rhabdomyolysis or prior intolerance of statin therapy
* Contraindication to magnetic resonance imaging