cyrilzakka/clinical-trials huggingface dataset:
Effects of Energy Drinks

This study is designed to test the efficacy of energy drinks. This is a double-blinded, crossover, randomized clinical trial, measuring the effect of the test drinks compared with placebo drink in 200 participants aged 18-70 years.

This study is designed to test the efficacy of an energy drink compared to placebo via a double-blind, crossover, randomized clinical trial. Energy levels will be assessed before and after consumption of the test beverages on 2 days separated by a week in 200 participants aged 18-70 years. The study is crossover because the participants will be (randomly) receiving one drink on Test Day 1 and the other drink on Test Day 2.

After signing written informed consent, participants will be fed a light lunch, and their pulse, weight and height measured. A baseline battery of computer-based tests to assess energy levels will be conducted. These computer-based measures will take \~40 minutes to complete and will include: a) a long-term memory test b) a Profile of Mood States (POMS2) brief form; c) Rapid Visual Information Processing (RVIP) test, d) The N-Back Task; d) Reaction time online test; f) the Flanker Task. Participants will then be asked to fill out a baseline survey (30 min), with questions about current health-related behaviors, specifically questions about physical activity and diet.

Upon completing the baseline battery (survey administered at test session 1 only), participants will be randomly administered the energy drink or the placebo to consume while observed. Subsequently, the battery of computer-based tests to assess energy levels will be re-administered 30 minutes, 2.5 hours and 5 hours after consumption of the test drink.

The study intervention will be double-blinded: participants will be blinded to whether they are receiving the active or the placebo drink, and study team members will also not be aware of the assignment.

When the study ends, full compensation will be given if the intervention is fully completed; if the intervention is not fully completed, partial compensation will be given.

Eligibility Criteria:
Inclusion Criteria:

* Fluent in reading English
* High school graduate as lowest education level

Exclusion Criteria:

* Non-smoker
* No diagnosed/treated cognitive/psychiatric conditions by self-report
* No diagnosed/treated diabetes, hypoglycemia or thyroid condition by self-report
* No current use of prescription stimulant medications by self-report
* No allergies or sensitivities to foods, ingredients or chemicals by self-report, that are contained in the test drink or placebo
* No diagnosed phenylketonuria
Effect of Progressive Exercise on Renal Transplant Patients

The goal of this interventional study is to determine the effect of progressive relaxation exercises on the vital signs and fatigue levels of patients with renal transplantation.

Renal transplant patients experience intense level of fatigue as well as vital sign problems due to treatment protocol. This research is designed to determine the effect of progressive relaxation exercises on vital signs and fatigue level of patients with renal transplantation.

In this study, the participants will be randomized in a single blind manner (participant) to either intervention (4 week exercise program) or control (routine care) groups.

Eligibility Criteria:
Inclusion Criteria:

* Patients underwent renal transplant within one year from the beginning of the study
* Patients having no communication problems
* Patients having a smart phone either own or o family member

Exclusion Criteria:

* Patients having musculoskeletal, cardiopulmonary, or psychiatric disorders
Trial of Protein Supplement on Vertebral Fusion in Posterior Spine Fusion Surgery

Receiving protein can affect the bone formation and maintenance by providing a structural matrix of the bone, optimizing the level of IGF-1, increasing intestinal calcium absorption, transferring phosphorous, and improving muscle strength.Therefore, protein may be effective on vertebral fusion by such mechanisms. In this trial patients undergoing elective posterior spine fusion surgery are divided into two groups of intervention or control.

A randomized, double blind, controlled trial will be conducted in patients undergoing elective posterior spine fusion surgery in Tehran, Iran. After a full review of the inclusion and exclusion criteria and explanation of the risks and benefits of the study, written consent form will be completed. The participants are 80 eligible posterior spine fusion surgery patients, aged ≥ 18 years. Intervention patients will be received 36 grams of protein supplement along with diet containing 1.2 g/kg/day of protein for 30 days after surgery and control patients will be received Carbo Mass along with diet containing 1.2 g/kg/day of protein 30 days after surgery. Patients will be evaluated for occurrence of vertebral fusion and enhanced recovery after 3 months surgery.

Eligibility Criteria:
Inclusion criteria:

* Adult patients 18-65 years
* Body mass index 18.5-30
* Candidate for the elective posterior spine fusion
* Without history of severe liver disorder
* Without history of Kidney disorder
* Without history of diabetes
* Without history of trauma and fracture of the vertebral
* Without history of osteoporosis
* Without history of Gastrointestinal malabsorption
* Without history of Parathyroid gland disorders
* Without taking medications that affect the metabolism of bone, such as calcitonin,
* bisphosphonate, corticosteroid
* No smoking
* serum level of vitamin 25 (OH) D ≤20 ng/l

Exclusion Criteria:

* Allergy or intolerance to protein or maltodextrine supplement
* Unwillingness to continue cooperation
Structuring Financial Incentives to Increase Physical Activity

The purpose of this study is to evaluate the effectiveness of different structures of long term financial incentives on increasing physical activity performed by subjects, as measured by the number of steps walked per day.

Investigators are interested in studying whether physical activity increases during an intervention period (with incentives) and a post-intervention period (with no incentives).

The proposed study is a field experiment. Adults within the ages of 25 and 60 years of age, and with a body mass index of 22 or higher will be eligible to participate.

The study will consist of (1) a two-week baseline period, (2) a 36-week intervention period, and (3) a 12-week follow-up period.

At the beginning of the study, subjects will be given a wearable fitness device and their daily step count will be monitored for two weeks; this is the baseline period. After the two-week baseline period, the subjects will be randomly assigned to one of the five different conditions (Control, Gain, Loss, Gain Streak, or Loss Streak) and will be given the goal to increase their baseline step counts by 2,500 steps.

=====

HYPOTHESES -- Investigators expect the following:

1. Loss Aversion: Subjects in the Loss treatment will achieve the goal on a greater number of days than subjects in the Gain treatment.
2. Streak: Subjects in the Gain treatment will achieve the goal on a greater number of days than subjects in the Gain Streak treatment.
3. Loss Streak: Subjects in the Loss treatment will achieve the goal on a greater number of days than subjects in the Loss Streak treatment. Whether subjects in the Loss Streak treatment will perform better or worse than subjects in the other two treatments will be investigated.

CONTRIBUTION -- Prior research has not examined the effect of a long term financial incentive (36 weeks) on individual behavior in achieving a goal. In this study, the investigators also examine two additional financial incentive structures: Gain Streak and Loss Streak. If the hypotheses are correct, the results have important implications for designing financial incentives to encourage good behavior and to encourage good habit formation across domains.

Eligibility Criteria:
Inclusion Criteria:

* Singapore citizens and permanent residents
* Adults with BMI greater than 22
* Ownership of a smartphone or tablet
* Only one member per household can participate in the study

Exclusion Criteria:

* Women who are pregnant or breast feeding, or who intend to become pregnant over next year
* Subjects who are already participating in another physical activity program or study
* Subjects who are unable to participate for a total of 1 year
* Subjects who are unwilling to wear the fitness device
* Subjects who already walk more than 10,000 steps a day (self-reported per-day-average over seven days)
* Subjects who have any of the following health conditions:

  * high blood pressure
  * high cholesterol
  * heart attack
  * heart failure
  * stroke
  * chronic obstructive pulmonary disease
  * kidney disease
  * diabetes (type 2)
Sugars-containing Beverage and Food Intake in Children

The purpose is to determine the effect of sugars in solution on food intake and subjective appetite in 9- to 14-year-old normal weight boys. The investigators hypothesize that food intake after all sugars-containing solutions will be decreased in comparison to the control solution, with similar reductions in FI between high-fructose corn syrup -55 (HFCS-55) and sucrose. Food intake will be measured 60 minutes after consumption of 50g of HFCS-55, sucrose or glucose, or a control treatment. Subjective appetite will be measured at 15, 30, 45, 60 and 90 minutes.


Eligibility Criteria:
Inclusion Criteria:

* Healthy, boy, born at full term and normal birth weight

Exclusion Criteria:

* Girl, on restricted diet, taking medication that affect appetite or food intake, have significant learning, behavioral, or emotional difficulties
A Trial Investigating the Pharmacokinetics and Pharmacodynamics of NNC0123-0000-0338 in a Tablet Formulation With Three Different Coatings in Healthy Subjects

This trial is conducted in Europe. The aim of the trial is to investigate the pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of NNC0123-0000-0338 (insulin 338) in a tablet formulation with three different coatings in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index 18.0-28.0 kg/m\^2 (both inclusive)
* Subject who is considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, ECG (electrocardiogram) and clinical laboratory tests performed during the screening visit, as judged by the investigator

Exclusion Criteria:

* Known or suspected hypersensitivity to trial products or related products
* Previous participation in this trial. Participation is defined as informed consent
* Presence of clinically significant acute gastro-intestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea) within 2 weeks prior to first dosing, as judged by the investigator
Long Term Outcomes of Patients With COVID-19

The investigators hypothesize that those with respiratory failure due to COVID-19 will have different burdens of mental and physical disability than those with respiratory failure who do not have COVID-19. Detecting these potential differences will lay an important foundation for treating long term sequelae of respiratory failure in these two cohorts.

The aim of this proposal to is to understand the extent and degree of physical disability, psychological sequelae, and cognitive dysfunction survivors of COVID-19 related critical illness will have upon hospital discharge, 6 months, and up to one year post discharge. These outcomes of interest will be evaluated prospectively. The investigators will perform these measures in Covid-19 patients with respiratory failure and compare them to non-Covid-19 patients with respiratory failure. The investigators also seek to determine the risk factors of these long-term complications in order to guide providers as to which patients should be screened for these deficits. Finally, the investigators will examine the association of various critical care interventions such as invasive versus noninvasive mechanical ventilation or use of sedatives and their effects on disability and cognitive dysfunction.

Eligibility Criteria:
Inclusion Criteria:

* adult patients admitted to the ICU

Exclusion Criteria:

* none
Safety and Efficiency of Photodynamic Therapy for Blie Duct Carcinoma

This research is a prospective randomized controlled trial.It aimed to determine longterm outcomes and factors associated with increased survival after photodynamic therapy (PDT) through T-tube compared with biliary drainage alone in patients presenting with unresectable bile duct cancer.


Eligibility Criteria:
Inclusion Criteria:

* 1.Patients with bile duct cancer 2.Patients are willing to join in this clinical trial.

Exclusion Criteria:

* 1.Patients with bile duct carcinoma can not suffer PDT procedure. 2.Allergy to photosensitizer
The Effect of Uric Acid Decrement on Endothelial Function in Patients With Chronic Renal Failure

In this prospective study, the investigators aimed to evaluate the effects of improved hyperuricemia, a minor cardiovascular risk factor, on endothelial dysfunction in patients with chronic kidney disease.

Endothelial dysfunction (ED) is a key event in the development of atherosclerotic cardiovascular disease observed in patients with chronic kidney disease (CKD). Experimental models have shown that hyperuricemia causes hypertension and renin angiotensin system activation. In this prospective study, the investigators aimed to evaluate the effects of improved hyperuricemia, a minor cardiovascular risk factor, on ED in patients with CKD.

Eligibility Criteria:
Inclusion Criteria:

* Laboratory finding of hyperuricemia
* Patients between ages of 18 and 60 years
* Non-diabetic patients
* Creatinine clearance values between 20 and 60 mL/min/1.73 m2

Exclusion Criteria:

* Low (\< 20 ml/min/1.73 m2) creatinine clearance,
* Patients with diabetes mellitus, ischemic heart disease, acute coronary syndrome, congestive heart failure (CHF) (New York Heart Association class II or greater), valvular heart disease and a history of cerebral infarction or transient ischemic attack.
* Patients taking urate lowering medication (allopurinol and probenecid)
Study to Evaluate the Safety and Tolerability of KRX-0502 (Ferric Citrate) in Children With Iron Deficiency Anemia Associated With Non-Dialysis Dependent Chronic Kidney Disease

This study will be conducted to evaluate the safety and tolerability of ferric citrate in pediatric participants with iron deficiency anemia (IDA) associated with non-dialysis dependent chronic kidney disease (NDD-CKD).


Eligibility Criteria:
Inclusion Criteria:

* Age 6 years to \<18 years at Screening
* Body Weight ≥12 kilograms (kg) at Screening
* Chronic kidney disease (CKD) stage 3 to 5, not on dialysis, with estimated glomerular filtration rate (eGFR) \<60 milliliters per minute (mL/min)/1.73 meters squared (m\^2) utilizing the "Bedside Schwartz" equation
* Hemoglobin (Hgb) ≥8.5 and ≤11.5 grams per deciliter (g/dL) at Screening
* Transferrin saturation (TSAT) ≤25% at Screening
* Ferritin ≤200 nanograms per milliliter (ng/mL) at Screening

Exclusion Criteria:

* Serum phosphorus level at Screening:

  * 6 to \<13 years: ≤4.0 milligrams per deciliter (mg/dL);
  * 13 to \<18 years: ≤2.7 mg/dL
* Liver transaminases (aspartate aminotransferase \[AST\] and/or alanine aminotransferase \[ALT\]) ˃3× the upper limit of normal at Screening
* Active significant gastrointestinal (GI) disorder, including overt gastrointestinal (GI) bleeding or active inflammatory bowel disease
* Unable to swallow pills
* Anemia due to causes other than iron deficiency anemia (IDA) of CKD
* Intravenous iron therapy or blood transfusion within 4 weeks before the Screening visit
* Participants with a functioning organ transplant
* Receipt of any investigational drug within 4 weeks before Screening
* Phosphate binder use during the Screening period
Tolerability of ALK Tree Tablet

This trial is performed to assess the tolerability of the ALK Tree Tablet in patients with birch pollen induced allergy


Eligibility Criteria:
Inclusion Criteria:

* A clinical history of birch pollen induced rhinoconjunctivitis (with or without mild to moderate asthma ) of at least two years prior to trial entry requiring symptomatic treatment during the birch pollen season.
* Positive Skin Prick Test response to Betula verrucosa
* Positive specific IgE against Bet v1
* FEV1 ≥ 70% of predicted value

Exclusion Criteria:

* No clinical history of perennial allergic rhinitis and/or asthma caused by an allergen to which the subject is regularly exposed and sensitised
* No clinical history of significant recurrent acute sinusitis (defined as 2 episodes per year for the last two years all of which required antibiotic treatment) or chronic sinusitis
* No conjunctivitis, rhinitis or asthma at the screening or randomisation visit
* No history of anaphylaxis, including anaphylactic food allergy, bee venom anaphylaxis, exercise anaphylaxis or drug induced anaphylaxis
* No history of angioedema
Efficacy and Safety of Sacubitril/Valsartan in African American Patients With Heart Failure With Reduced Ejection Fraction

There is limited long-term evidence specific to AAs with HFrEF on sacubitril/valsartan therapy. Plasma NT-proBNP levels are lower in AA individuals as compared to Caucasian individuals in general. However, the mechanism of action of sacubitril specifically targets the activity of BNP. Therefore, there is the potential that the mechanism of action of sacubitril/valsartan may be less effective in AAs.

To assess the efficacy and safety of sacubitril/valsartan in AA patients with HFrEF by comparing the outcomes of AA patients on ARNI therapy plus SOC (with or without hydralazine/isosorbide \[H-IDSN\]) to AA patients receiving ACEi/ARB therapy plus SOC (with or without H-ISDN).

Eligibility Criteria:
Inclusion Criteria:

* Self-identified as AA
* NYHA class II-IV symptoms
* Left ventricle EF \<40%
* Receiving stable doses of standard therapy, including ACE inhibitors or ARBs, ARNI (within a month from discharge), combination H-ISDN, beta blockers, digoxin, spironolactone, and diuretics as tolerated.
* Patient must have minimum of three months follow-up

Exclusion Criteria:

* Patients not meeting inclusion criteria
Lactobacillus Reuteri in the Prevention of Antibiotic Associated-diarrhea and Clostridium Difficile

The purpose of this study is to find whether Lactobacillus reuteri prevents antibiotic-associated diarrhea and related Clostridium difficile infections. Subjects will be admitted from the University Hospitals Case Medical Center. They will be randomly assigned to an intervention group receiving L. reuteri or a placebo. Supplementation will occur during antibiotic treatment and for an additional 7 days after cessation of treatment. Data collection will occur at baseline, end of antibiotic use, 7 days after antibiotic cessation, and 21 days after antibiotic cessation. Primary data includes diarrhea instances. Secondary data includes severity of diarrhea, presence of C. difficile toxins, and presence of other GI symptoms.

The data being measured for this study include:

Primary outcome = incidence of diarrhea during and after treatment with antibiotics. An episode of diarrhea is defined as the discrete period between the time when stool output meets or exceeds three soft and unformed or watery bowel movements to the time when formed stools return, which must be at least 48 hours later.

Secondary variables:

1. severity of diarrhea measured as the discrete period between the time when stool output meets or exceeds 3 soft and unformed or watery bowel movements to the time when formed stools return.
2. frequency of stool samples positive for C. Difficile toxin A or B at baseline, when presenting with diarrhea during the study period, and at the follow-up 21 days post-antibiotic-treatment to detect possible clearance of C. Difficile, in patients ingesting L. reuteri versus placebo.
3. frequencies of other gastrointestinal symptoms at 1, 2, and 4 weeks, in the L. reuteri group versus placebo and assessed by the validated Gastrointestinal Symptom Rating Score.

Eligibility Criteria:
Inclusion Criteria:

* Receiving antibiotics for not more than 48 hours prior to enrollment and free from diarrhea
* able to understand and sign informed consent and HIPPA
* available throughout the study period
* subjects should have the mental ability to understand and willingness to fulfill all the details of the protocol

Exclusion Criteria:

* three or more soft and unformed or watery stools per day at admission
* receiving chemotherapy or radiation therapy
* diagnosis of inflammatory bowel disease
* NPO without PO meds
* neutropenia (an absolute neutrophil count (ANC) of less than 1500/microL)
* HIV positive with a CD4+ T-lymphocyte count \<400 per mcL blood
* requiring care in an intensive care unit
* status-post bowel resection during hospitalization
* patient's receiving antibiotics four weeks prior to hospitalization
* patient with severe life threatening illness or immunocompromised
* pregnancy
Personalized Treatment for Eating Disorders Versus CBT-E Trial

The scientific premise, developed from past work, is that treatment personalized based on idiographic models (termed Network Informed Personalized Treatment; NA-PT) will outperform the current gold-standard treatment (Enhanced Cognitive Behavioral Therapy: CBT-E). The study goals are to (1) develop and test the acceptability, feasibility, and preliminary efficacy of a randomization of NA-PT versus CBT-E and (2) to test if network-identified precision targets are the mechanism of change. These goals will ultimately lead to the very first personalized treatment for ED and can be extended to additional psychiatric illnesses. Specific aims are (1) To collect preliminary data on the feasibility and acceptability of the randomization of NA-PT (n=40) for EDs versus CBT-E (n=40), (2) To test the initial clinical efficacy of NA-PT versus CBT-E on clinical outcomes (e.g., ED symptoms, body mass index, quality of life) and (3) To examine if changes in NA-identified, precision targets, as well as in dynamic network structure, are associated with change in clinical outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-65
* Meets criteria for DSM-5 defined AN, BN, BED, or OSFED (Atypical AN and Atypical BN)
* Not currently receiving psychological treatment focused on ED

Exclusion Criteria:

* Under 18
* Over 65
* Does not meet criteria for DSM-5 defined AN, BN, BED, or OSFED (Atypical AN and Atypical BN)
* High and active Suicidality
* Active Mania
* Medically Compromised Status including extremely low weight - less than or equal to 75% median BMI for age, sex, and height
* Simultaneous psychological treatment focused on ED
Patch Test Skin Irritation/Sensitization of Cetaphil Daily Facial Moisturizer SPF 50

Determine if Cetaphil Daily Facial Moisturizer SPF 50 proves to be a contact sensitizer or irritant in certain individuals.


Eligibility Criteria:
Inclusion Criteria:

* Not currently under a doctor's care
* Free of dermatological or systemic disorder which would interfere with the results
* Free of any acute or chronic disease
* Will complete a preliminary medical history form and are in general good health
* Can read, understand, and sign informed consent

Exclusion Criteria:

* Under 18 years old
* Currently under doctor's care
* Currently taking any medication
* History of acute or chronic disease
* Diagnosed with chronic skin allergies
* Pregnant or lactating