cyrilzakka/clinical-trials huggingface dataset:
The Effect of Diet Counseling for Low Calorie-High Protein on the Body Composition, Inflammation Marker, and Oxidative Stress Marker in Obese People With Weight Cycling

The world prevalence of obesity in adult population in 2014 was nearly 13% while in Indonesia, it has reached 32.9% in the same year. Obesity is an established risk factors for cardiovascular diseases. A large proportion of people who had succeeded to reduce body weight failed to maintain it (weight cycling). Studies were inconclusive about the best composition in the diet for such people to have a better life quality and reduce risk factors from non-communicable disease. The purpose of this research was to evaluate the body composition changes, Inflammation marker and oxidative stress marker changes resulted from low calorie high protein and standard protein diet programme in obese people with history of weight cycling.

This is an open-randomized clinical trial of weight loss program as a part of a larger study researching the effect of low calorie high protein diet to body composition, oxidative stress, inflammation marker and metabolic syndrome in obese with weight cycling. Subjects were assigned to low calorie diet and were randomly distributed into two intervention groups, namely high protein group (22-30 % of total calories intake) and standard protein group (12-20%). Anthropometry, body composition data, and blood sample (for inflammation marker (HsCRP) and oxidative stress (malondialdehyde and glutathione)) were taken at baseline and at the end of the study. Subjects were followed up to 8 weeks with daily reminder and weekly counselling


Eligibility Criteria:
Inclusion Criteria:

* body mass index ranging from 25 - 35 kg/m2
* history of weight loss ≥2 kg and regaining weight into or exceeding its initial body weight at least twice in last five years

Exclusion Criteria:

* diabetes mellitus
* history of gastrointestinal tract resection
* hormonal disorders
* using hormonal contraception
* menopause,
* kidney function disruption
The Effect of High and Low Sodium Intake on Urinary Aquaporin-2 in Healthy Humans.

The aim of the study is to test the hypothesis that the function and/or regulation of aquaporin 2 and/or endothelial sodium channels in the principal cells of healthy humans is abnormal at high and low sodium intake


Eligibility Criteria:
Inclusion Criteria:

* Caucasic men and women
* Age 18-65 years
* Body mass index less or equal to 30 Kg/m2

Exclusion Criteria:

* Arterial hypertension
* History or clinical signs of heart, brain, lung, kidney, malignant or endocrine organ disease.
* Abnormal biochemical screening of the blood regarding: red and white cell count, B-hemoglobin, P-sodium, P-potassium, P-creatinine, P-albumine, P- bilirubin, P-alanine aminotransferase, P- alkaline phosphatase, p-cholesterol and B-glucose.
* Abnormal screening of the urine regarding: blood, albumine and glucose.
* Alcohol or drug abuse
* Drug use except oral contraceptives
* Smoking
* Abnormal electrocardiogram
* Blood donation within one month of the first examination day
* Pregnancy
* Unwillingness to participate
Endoscopic Ultrasound-guided Needle-based Confocal Laser Endomicroscopy in Solid Pancreatic Masses

The differential diagnosis of solid pancreatic masses by endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) is currently suboptimal. Needle-based confocal laser endomicroscopy (nCLE) is a novel endoscopic technique, which is compatible with the 19-gauge FNA needle. Under endoscopic ultrasonography (EUS) guidance, nCLE enables real-time in vivo imaging of lesion tissues at cellular and subcellular levels. This study aimed to describe nCLE interpretation criteria for the characterization of pancreatic masses, with histopathological correlation, and to perform the validation of these criteria.


Eligibility Criteria:
Inclusion Criteria:

* patients with any pancreatic mass

Exclusion Criteria:

* Patients aged \<18 years or \>80 years
* Known allergy to fluorescein dye
* Previous EUS-FNA performed within the past 3 months, and usualcontraindications to EUS-FNA
* Pregnancy or breastfeeding
* Inability to provide informed consent
Immunogenicity Study of an Inactivated Hepatitis A Vaccine in Infants and Young Children

Infants born to immune mothers and therefore having passively-transferred maternal antibody (PMA) to hepatitis A virus (HAV) have a blunted immune response to hepatitis A vaccine. We compared the immunogenicity of hepatitis A vaccine among infants with and without PMA, vaccinated on different schedules. We found that when vaccination is begun at or after 12 months of age, there was no difference in the immune response to the vaccine between infants born to immune vs. susceptible mothers.

Background: Infants with passively-transferred maternal antibody (PMA) to hepatitis A virus (HAV) have a blunted immune response to hepatitis A vaccine. We compared the immunogenicity of hepatitis A vaccine among infants with and without PMA, vaccinated on different schedules.

Methods: Infants were randomized to one of three groups, each receiving two doses of 720 EL.U. of hepatitis A vaccine (HAVRIX, Glaxo SmithKline) according to the following schedules: Group 1 at ages 6 and 12 months; Group 2 at ages 12 and 18 months; Group 3 at ages 15 and 21 months. We determined antibody to HAV (anti-HAV) status of mothers at the time of delivery, and measured infants' anti-HAV concentrations at the time of the first vaccine dose (baseline), and at 1, 7 and 12 months thereafter. Anti-HAV concentrations \> 33 milli-International Units/milliliter (mIU/mL) were considered protective. We monitored adverse reactions using diary cards and chart reviews.

Results: A total of 239 infants were enrolled, including 134 born to anti-HAV negative mothers (Groups 1N, 2N, 3N) and 105 born to anti-HAV positive mothers (Groups 1P, 2P, 3P).

At month 12, 6 months after the second vaccine dose, the difference in GMC between Groups 1P and 1N was the only statistically significant difference within groups (p\<0.05). There were no statistically significant differences in GMC among groups of infants born to anti-HAV negative mothers ("N" groups), but the difference between Group 1P and Group 3P infants was significant (p \< 0.05). No serious adverse reactions related to vaccination were detected.

Conclusions: Hepatitis A vaccine is immunogenic among infants born to anti-HAV negative mothers, and among those born to anti-HAV positive mothers and vaccinated beginning as young as 12 months old. The persistence of PMA for at least six months among the majority of infants born to anti-HAV positive mothers results in lower seroconversion rates and GMC's.

Eligibility Criteria:
Inclusion Criteria:term infant with normal growth and development, considered to be healthy at age 6 months; written informed consent by parent/guardian -

Exclusion Criteria:received or expected to receive immune globulin or blood/blood products while enrolled; received or expected to receive immunosuppressive therapy within 30 days of vaccination or has immune deficiency; currently enrolled in another vaccine trial; progressive or unstable neurological disorder

-
The Effect of Horticultural Therapy on Loneliness and Life Satisfaction in Elderly Adults Living in Nursing Home

Loneliness in elderly individuals increases with age and negatively affects individuals by decreasing life satisfaction. In recent years, horticultural therapy is a type of therapy that has developed and is added routine care of elderly individuals living in nursing homes. Social interaction, life satisfaction, feelings of success and responsibility and increase while loneliness and depression levels decrease through human-nature interaction in horticultural therapy.

In our country, no study has been found on the effects of horticultural therapy on physical or mental health in elderly individuals. This research will be conducted as a randomized control group study to examine the effects of horticultural therapy on loneliness and life satisfaction in elderly individuals living in nursing homes.

In recent years, the elderly population is increasing in Turkey and around the world. In our country from 2002 to 2022, the number of elderly people receiving care increased 2.8 times. Elderly individuals frequently complain about loneliness and think that they are abandoned. Loneliness is a multidimensional concept consisting of emotional loneliness and social loneliness, and reported that it reduces life satisfaction in elderly individuals.

There are many non pharmacological applications aimed at reducing loneliness and increasing life satisfaction however in recent years, the use of horticultural therapy in the world has attracted attention. In horticultural therapy interventions, gardening activities are carried out using indoor and outdoor plants. The plants which is medicinal and aromatic selected according to culture and cultivation. The plants contribute to the improvement of physical and mental health by stimulating 5 senses that visual, hearing, tasting, touching and smell.

Horticultural therapy is important in terms of providing social activity, reducing loneliness and increasing life satisfaction in elderly individuals using the healing power of nature.

Horticultural therapy is also used by nurses who are mental health professionals. In Turkey, there is no study to examine effects of horticultural therapy effects on mental health in elderly individuals. It is thought that with this study, it will be important to apply a new method in our country and contribute to nursing science in non-pharmacological applications.

Eligibility Criteria:
Inclusion Criteria:

* Over 60 years old,
* Being literate,
* Living in nursing home for at least 3 months,
* Not diagnosed with dementia,
* Mini Mental Test Score\>24
* No additional neurological disease,
* No history of serious psychiatric illness,
* Not in the acute phase of a systemic disease,
* No vision or hearing loss that would hinder gardening activities,
* Does not have a physical disability that would hinder gardening activities,
* No history of falls,
* Not participating in different applications at the same time.

Exclusion Criteria:

* Does not meet the inclusion criteria,
* Persons with allergic reactions to soil and plants that may hinder with gardening activities.
A Study of 0.15% Brimonidine Tartrate in Patients With Primary Open Angle Glaucoma and Ocular Hypertension

This study will evaluate 0.15% brimonidine tartrate in patients with primary open angle glaucoma and ocular hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of open-angle glaucoma or ocular hypertension

Exclusion Criteria:

* Used Alphagan® in previous 3 months
Safety and Efficacy of SCD in AKI or ARDS Patients Associated With COVID-19 Infections

Selective Cytopheretic Device (SCD) treatments will improve survival in patients testing positive for COVID-19 infection diagnosed with Acute Kidney Injury (AKI) or ARDS.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent obtained
* Positive COVID-19 test
* Must be receiving medical care in an intensive care nursing situation
* Non-pregnant females
* Intent to deliver full supportive care through aggressive management utilizing all available therapies for a minimum of 96 hours.
* Platelet count \>30,000/mm3 at Screening
* Clinical diagnosis of AKI requiring CRRT or ARDS

Exclusion Criteria:

* Cardiovascular instability that precludes initiation of continuous renal replacement therapy (CRRT).
* Irreversible brain damage based on available historical and clinical information.
* Presence of any solid organ transplant at any time.
* Patients with stem cell transplant in the previous 100 days or who have not engrafted.
* Acute or chronic use of circulatory support device other than ECMO such as LVADs, RVADs, BIVADs.
* Metastatic malignancy which is actively being treated or may be treated with chemotherapy or radiation during the subsequent three month period after study treatment.
* Chronic immunosuppression defined as \>20 mg prednisone qd alone without other immunosuppressant medications (ie (cyclophosphamide, azathioprine, methotrexate, rituximab, mycophenolate, cyclosporine).
* Patient is moribund or chronically debilitated for whom full supportive care is not indicated.
* Concurrent enrollment in another interventional clinical trial. Patients enrolled in observational studies (NO TEST DEVICE OR DRUG USED) are allowed to participate.
* Any reason the Investigator deems exclusionary.
A Study of Aprepitant (MK-0869) in Pediatric Participants Undergoing Surgery (MK-0869-148)

This two part study will determine the appropriate dosing regimen of aprepitant for the prevention of postoperative nausea and vomiting (PONV) in pediatric participants 6 months to 17 years of age, by assessing pharmacokinetic parameters and monitoring safety and tolerability of administered doses. Part I will be an open label investigation of a single dose of aprepitant measuring pharmacokinetics at specified time points up to 48 hours after aprepitant dosing. Part II will be a double blind trial of participants randomized to receive either aprepitant or ondansetron.


Eligibility Criteria:
Inclusion Criteria:

* Participant is scheduled to have surgery requiring a 48 hour (Part I) or 24 hour (Part II) hospital stay
* Participant is scheduled to receive general anesthesia
* Participant is scheduled to receive opioids (e.g. morphine or fentanyl)
* Female participants of childbearing potential must have negative pregnancy test prior to drug administration
* A female participant who is of reproductive potential must agree to remain abstinent or use a barrier form of contraception for at least 14 days prior to, throughout, and for at least one month following the last dose of study medication
* Participant weighs 6 kg or more

Exclusion Criteria:

* Participant is undergoing surgery for a life-threatening condition
* Participant is pregnant or breast feeding
* Participant has vomited within 24 hours prior to surgery
* Participant has a known history of QT prolongation or is currently taking other medicinal products that lead to QT prolongation
* Participant has an active infection (e.g., pneumonia), congestive heart failure, bradyarrythmia, any uncontrolled disease (e.g., diabetic ketoacidosis, gastrointestinal obstruction), evidence of any clinically significant respiratory, metabolic, hepatic, renal dysfunction, or a history of any illness, including morbid obesity, that might pose unwarranted risk
Methodology Issues in a Tailored Light Treatment for Persons With Dementia - Aim 2

Aim 2 will investigate the effect of 3 different light exposure lengths on sleep, mood and agitation in persons with Alzheimer's disease. Participants will be randomly assigned to one of three conditions of light exposure: 1) 2-h morning light exposure; 2) 4-h morning light exposure; and 3) all day light exposure.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Alzheimer's disease or related dementia with a Montreal Cognitive Assessment score \<25
* Sleep disturbance with a Pittsburgh Sleep Quality Index score ≥5

Exclusion Criteria:

* Extensive brain vascular disease, traumatic brain injury, multiple sclerosis, Parkinson's Disease
* Obstructing cataracts
* Severe macular degeneration
* Use of sleep medication
* Use of oral melatonin
* untreated moderate to severe sleep apnea
* Severe restless leg syndrome
* Blindness
Iodobenzylguanidine Meta-I131 and Topotecan in Young Patients With Refractory or Relapsed Metastatic Neuroblastoma

RATIONALE: Radioactive drugs, such as iodobenzylguanidine meta-I131, may carry radiation directly to tumor cells and not harm normal cells. Drugs used in chemotherapy, such as topotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. A stem cell transplant may be able to replace the cells that were destroyed by iodobenzylguanidine meta-i131 and topotecan hydrochloride.

PURPOSE: This phase II trial is studying the side effects of iodobenzylguanidine meta-I131 given together with topotecan hydrochloride and to see how well it works in treating young patients with refractory or relapsed metastatic neuroblastoma.

OBJECTIVES:

Primary

* Determine the antitumor activity of iodobenzylguanidine meta-I131 (\^131I-MIBG) and topotecan in young patients with refractory or relapsed metastatic neuroblastoma.

Secondary

* Determine the hematological and extra-hematological toxicities of this regimen.

OUTLINE: This is a multicenter study.

During the 21 days before treatment begins, autologous peripheral blood stem cells (PBSC) are collected.

Patients receive topotecan hydrochloride IV over 30 minutes daily on days 1-5 and iodobenzylguanidine meta-\^131I IV over 2 hours on day 1. Treatment repeats every 21 days for 2 courses. Patients also undergo total-body irradiation.

On day 10 of the second course, autologous PBSC are reinfused.

After completion of study therapy, patients are followed at 6 and 12 months.

Eligibility Criteria:
Inclusion criteria:

* Histologically confirmed neuroblastoma
* Metastatic disease that is recurrent or refractory to induction therapy
* Primary or metastatic tumor target with MIBG fixation (tumor/soft tissue) \> 2
* Autologous bone marrow or peripheral blood stem cells must be available
* WHO performance status (PS) 0-1 OR Lansky PS 70-100%
* Life expectancy \> 2 months
* ANC ≥ 1,000/mm³
* Platelet count ≥ 100,000/mm³
* Creatinine clearance normal for age
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No prior hypersensitivity to topotecan or its excipients
* No toxicity to other organs ≥ NCI-CTCAE v3.0 grade 2
* No other debilitating disease
* No HIV positivity
* More than 30 days since prior external-beam radiation (6 weeks if cranio-spinal, abdominal, or pulmonary)
* At least 3 weeks since prior chemotherapy (6 weeks for mitomycin C or nitrosoureas)
* No other contraindicated biologic therapy that cannot be discontinued for ≥ 4 courses during MIBG therapy

Exclusion criteria:

* Pregnancy or breastfeeding women
* HIV positive
* Participation to another phase I,II or III clinical trial
* Other invalidating pathology
* Concomitant treatment interfering with MIBG
* Hypersensibility to Topotecan
HELP-HY: Health Education and sLeep Program in HYpertension

Hypertension is the major risk factor for cardiovascular and cerebrovascular diseases worldwide. The escalating prevalence of inadequate sleep now parallels that of hypertension. Observational and experimental evidence favoring a causal relation between insufficient sleep and hypertension are particularly compelling - sleeping 6 hours or less per night is associated with a 20-32% higher probability of incident hypertension. Since sleep curtailment is largely voluntary, sleep deficiency may be corrected and the detrimental health consequences potentially reversed.

In this study the investigators aim to investigate the effects of 8 weeks of sleep enhancement/extension vs health education in prehypertensive and stage 1 hypertensive subjects who report habitual short sleep (≤6.5 hours/night).


Eligibility Criteria:
Inclusion criteria:

* Age: 18 to 65 (inclusive)
* Gender: both males and females
* Body mass index (BMI): 18.5-34.9 kg/m2
* Habitual sleep duration \<7 hours and voluntary prolongation of sleep when circumstances allow (as indicated by napping and/or \>45 min catch-up sleep during weekends or holidays)
* Presence of prehypertension (office systolic BP (SBP) 120-139 mmHg and/or diastolic BP (DBP) 80-89 mmHg) , Stage 1 hypertension (office SBP 140-159 mmHg and/or DBP 90-99 mmHg ) , or currently taking antihypertensive medications
* Either on no prescription medications (other than oral contraceptive pills, or intrauterine devices) or on stable medical regimen for at least 1 month, if taking prescription medications for chronic conditions
* Not pregnant or breast feeding and not intending to become pregnant or breast feed
* Not a current smoker or tobacco user
* Ability to provide written informed consent.

Exclusion criteria:

* Vulnerable study populations will be excluded
* Pregnancy
* Smoking
* Shift-work
* Travel across \>2 time zones in the previous month
* Presence of overt cardiovascular diseases, diabetes, chronic kidney disease, cancer, sleep/circadian disorders, psychiatric disorders
* If taking prescription medications for chronic conditions, change in therapy (type, frequency and/or dosage) over the previous month
* Sleep aids
* Habitual sleep duration ≥7 hours
* Excessive alcohol (\>14 drinks/week in men and \>7 drinks/week in women) and/or excessive caffeine intake (\>400 mg)
* Currently on a diet and/or actively trying to lose weight
* History of drowsing driving
* Severe daytime sleepiness (score \>15 at the Epworth Sleepiness Scale)
* Current or previous (during the past 2 months) participation in other research studies at the discretion of study personnel
* Blood/plasma donation during the past 2 months
* Unwillingness or inability to adjust sleep schedule
Irinotecan Liposome in Combination With 5-FU/LV Versus 5-FU/LV in Second-line Therapy for Gemcitabine-Refractory Pancreatic Cancer

To evaluate efficacy and safety of irinotecan hydrochloride liposome in combination with 5-FU/LV as second-line treatment for locally advanced or metastatic pancreatic cancer after treatment failure with gemcitabine-based therapy.


Eligibility Criteria:
Inclusion Criteria:

1. Histologically or cytologically confirmed pancreatic cancer;
2. Unresectable locally advanced or metastatic disease ;
3. Documented disease progression after first-line treatment gemcitabine based therapy
4. ECOG: 0-1;
5. Adequate organ and bone marrow function;
6. sign an informed consent.

Exclusion Criteria:

1. Active CNS metastasis;
2. Uncontrolled tumor-related pain;
3. Clinically significant GI disorders;
4. Significant cardiovascular disease;
5. Active infection or uncontrolled fever;
6. Pregnant or breast feeding patients;
7. Allergic to a drug ingredient or component;
8. The investigators determined that other conditions were inappropriate for participation in this clinical trial.
Influence of a Computer Game on Youth's Choices of Activities

Study of activity choices after playing a computer game.


Eligibility Criteria:
Inclusion Criteria:

* Like study foods, healthy

Exclusion Criteria:

* Medical conditions, psychological disorders, food allergies
Study on the Effects of an AMP Challenge on Asthmatic Patients Following Treatment With Fluticasone Propionate

Inhaling AMP causes an inflammatory response in the lung. This study will investigate whether 5-days of treatment with fluticasone propionate protects the lung from responding to the AMP in this way.

A randomised, double-blind, placebo-controlled, incomplete block, 4-period crossover study to investigate the effects of 5-day repeat inhaled doses of fluticasone propionate (BID, 50-2000 mcg) on airway responsiveness to adenosine-5'-monophosphate (AMP) challenge when delivered after the last dose in mild asthmatic subjects

Eligibility Criteria:
Inclusion Criteria:

* Female of non-childbearing potential
* Using appropriate contraception.
* Mild asthmatic, non (or ex) smokers.
* Has inflammatory response to AMP.
* Otherwise healthy, not using any steroids.

Exclusion Criteria:

* Have a history of life-threatening asthma, defined as an asthma episode, which required intubation and/or was associated with either hypercapnea, respiratory arrest or hypoxia seizures.
* Have a known sensitivity to corticosteroids.
* Have a history of milk protein allergy.
* Test positive at the screening visit for hepatitis B or C or HIV