bioihbjkbjnl/mcl2 huggingface dataset:
Insomnia and Drug Relapse Risk
Condition: Poor Quality Sleep; Opiate Addiction
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The purposes of this study are:

        1. to evaluate the relationship between subjective complaints of sleep and objective
           measures of sleep quality, as measured through polysomnography, and

        2. to evaluate the efficacy of trazodone, as compared to placebo, in individuals early in
           methadone maintenance.
    

Detailed description: 
      Individuals new to methadone maintenance will be asked to participate in this 6-month,
      double-blind, randomized control trial. All participants will complete a baseline interview,
      a medical screening and follow-up interviews at 1, 3 and 6-months post-baseline. These
      interviews take approximately 60 minutes, and survey various areas of the participants'
      experiences, including basic demographic information, mood, sleep and substance use areas.
      All participants will also be asked to complete a 2-night sleep monitoring at the time of the
      baseline interview and again at the 1-month follow-up interview. Participants will also
      receive study medication; half of the participants will receive a placebo medication, and the
      other half will receive Trazodone, a widely-prescribed, well-tolerated, low side-effect
      medication. Neither the participant nor the study staff will know which medication the
      participant is taking while the participant is actively enrolled in the study. This
      information can be available to the participant at the end of his/her study participation.
    

Intervention name(s): Trazodone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 50 mg 1-3 capsules at bedtime for 3 months; 1-3 at bedtime
Other intervention name(s): Desyrel; Oleptro; Beneficat; Deprax; Desirel; Molipaxin; Thombran; Trazorel; Trialodine; Trittico; Mesyrel; Sugar pill
Intervention MeSH terms: Trazodone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: sleep quality; methadone; substance use
UPHS Weight Loss Study
Condition: Obesity
MeSH terms: Weight Loss
Study type: Interventional

Summary: 
      The goal of this study is to compare a novel approach using financial incentives to changes
      in health benefit design and their impact on employee weight loss.
    

Detailed description: 
      Employers are increasingly looking for opportunities to encourage weight loss among
      employees. While studies have shown that financial incentives can effectively encourage
      weight loss, little is known about their use in health benefits design. The goal of this
      study is to determine whether a financial incentive program delivered to obese University of
      Pennsylvania Health System employees can effectively encourage weight loss when compared to
      changes in health benefit design.

      This is a randomized controlled trial involving financial incentives with four study arms:
      control, delayed gratification, immediate gratification, and financial incentive with
      frequent feedback. Participation in this study will last about 12 months.

      The primary goal of the study is to test the effects of a novel financial incentive program
      using a lottery with frequent feedback to normal benefit design structures.
    

Intervention name(s): Financial incentive
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Health Services Research
Short Term Efficacy and Safety of Perispinal Administration of Etanercept in Mild to Moderate Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      While the cause of AD is still unknown, evidence suggests it develops because of a complex
      series of events in the brain that occur over time. Two pathways possibly involved in
      development of AD are inflammation and oxidative stress. Scientists have linked chronic
      inflammatory events in the brain with the onset and progression of Alzheimer's Disease.
      Oxidative stress has also been implicated in the pathogenesis of a number of neurological
      disorders including Alzheimer's Disease.

      Etanercept (Enbrel®) is an approved drug for the treatment of several forms of arthritis when
      administered by injection. Some research suggests that etanercept, when administered by
      injection into the tissues close to the spinal column (perispinally), may modulate certain
      aspects of the immune system and provide some beneficial effect for people with Alzheimer's
      disease. Studies suggest that supplementation with specific nutrients may also have a
      positive effect in support of cognitive function.

      This study will be conducted at one research office with volunteers who have been diagnosed
      with mild to moderate Alzheimer's disease. Each qualifying participant will be randomly
      assigned to receive an etanercept injection plus nutritional supplements for 6 weeks followed
      by a crossover and a washout period of 4 weeks to then receiving nutritional supplements
      alone or vice versa for another 6 weeks.

      Participants will undergo blood and urine safety assessments at the beginning and end of each
      6 week treatment period. During 4 of the 6 weekly visits in the treatment period with the
      injections, you will complete the cognitive tests twice; once before and once 2 hours after
      the injection. During 4 of the 6 weekly visits in the treatment period without the
      injections, you will also complete the cognitive tests twice; once before and once 2 hours
      after being asked to lie down onto a table for 5 minutes. You will be allowed to continue
      your standard of care for Alzheimer's disease throughout your participation in the study.
    


Intervention name(s): Etanercept; Curcum.Luteol.Theaflav.Lip.Acid,FishOil,Quercet.,Resveratr.
Intervention type(s): Biological; Dietary Supplement
Other intervention name(s): Enbrel®; Super Bio-Curcumin; Super Omega-3; Optimized Quercetin; Optimized Resveratrol
Intervention MeSH terms: Etanercept; Curcumin; Resveratrol; Quercetin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Alzheimer's Disease; Dementia; Cognitive decline; Cognitive disorder; Degenerative brain disease; Cognitive impairment; Memory loss; TNF-alpha
The Relationship Between Adipokines, Obesity and Insulin Resistance in Women With Polycystic Ovarian Syndrome
Condition: Polycystic Ovarian Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Observational

Summary: 
      To evaluate possible clinical effects of adipokines , ( ghrelin, resistin and adiponectin),
      in obese and non-obese patients with polycystic ovary syndrome (PCOS).
    

Detailed description: 
      Seventy selected PCOS patients will be recruited for this study, and will be divided into two
      groups based on their body mass index (BMI): 35 obese (BMI≥ 25 kg/m2, group A), 35 non-obese
      (BMI<25 kg/m2, group B). In addition, 35 healthy non-obese women (BMI<25 kg/m2) will bw
      enrolled as the control (group C). Serum levels of FSH (follicle stimulating hormone), LH
      (luteinizing hormone), T(testosterone), glucose, insulin, adiponectin, resistin and resistin
      will bw detected, and compared the differences of them among three groups
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Females with PCOS in child bearing age who presented at reproductive and endocrinology
        clinics at Ain Shams University Maternity Hospital
      
Biospecimen description: 
      BLOOD SAMPLE
Use of Sildenafil (Viagra) to Alter Fatigue, Functional Status and Impaired Cerebral Blood Flow in Patients With CFS
Condition: Chronic Fatigue Syndrome
MeSH terms: Fatigue Syndrome, Chronic; Syndrome; Fatigue
Study type: Interventional
Phase: Phase 4

Summary: 
      Use of Viagra to Alter Symptoms in Patients with Chronic Fatigue Syndrome (CFS)
    

Detailed description: 
      Use of Sildenafil (Viagra) to Alter Fatigue, Functional Status and Impaired Cerebral Blood
      Flow in Patients with Chronic Fatigue Syndrome.
    

Intervention name(s): Sildenafil (Viagra); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 25 mg tid of either Sildenafil(Viagra) for first week. 50 mg tid of either Sildenafil (Viagra) for second week. 100 mg tid of either Sildenafil (Viagra) 3rd,4th, 5th and 6th week of study participation.; Placebo pills 3X/day for 6 weeks
Intervention MeSH terms: Sildenafil Citrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Phase I Study to Evaluate Bioavailability of Naproxen as PN400 Compared to Naproxen as Proxen S and Naprosyn E
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to investigate the uptake in the body of naproxen; one of the two
      active substances in PN400. We also want to show that the body's uptake of naproxen given as
      PN400 is comparable to that of currently marketed naproxen tablets.
    


Intervention name(s): PN400; Naproxen (Proxen S); Naproxen (Naprosyn E)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oral; Oral; Oral
Other intervention name(s): VIMOVO™; Proxen S; Naprosyn E
Intervention MeSH terms: Naproxen
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Phase I; Healthy Volunteer
Effect of Saccharomyces Boulardii in Patients in the Waiting List for Liver Transplant
Condition: Liver Cirrhosis
MeSH terms: Liver Cirrhosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the effect of Saccharomyces boulardii in patients in
      the waiting list for liver transplant.
    

Detailed description: 
      Increased intestinal permeability are related to the major complications of liver cirrhosis.
      The administration of probiotics has been suggested to improve the barrier function of the
      mucosa and consequently avoid the complications of the disease. The objective of this study
      was to evaluate the effect of Saccharomyces boulardii in patients in the waiting list for
      liver transplant.

      Eighteen patients were treated with Saccharomyces boulardii. Intestinal permeability
      (lactulose/mannitol ratio) and laboratory parameters were evaluated immediately before the
      beginning of treatment, after a thirty-day period of treatment with probiotic and at the end
      of the second study month (after a thirty-day period without treatment with probiotic).
      Twenty healthy volunteers were also submitted for the intestinal permeability test.
    

Intervention name(s): Saccharomyces boulardii
Intervention type(s): Drug
Intervention description(s): Oral capsule with 200 mg lyophilized S. boulardii-17 (about 4x108 cells), 6 mg sucrose and 2.4 mg magnesium stearate (Floratil®).
Other intervention name(s): Floratil
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Probiotic; liver; transplant; permeability
Biomarkers Serum Collection Methodology Pilot Study
Condition: Hemophilia A
MeSH terms: Hemophilia A
Study type: Observational

Summary: 
      The purpose of this study is to compare the standard collection of whole blood in tiger top
      tubes for serum collection versus a collection method of added FVIII to whole blood samples
      in the hemophilia population for routine biomarker assays to ensure reliable assay results.
    

Detailed description: 
      20 adults with severe Hemophilia A seen in one HTC site for routine blood drawing will be
      consented for discard blood sampling.

      Half of the whole blood discard will be placed in a tiger top test tube, and half of the
      whole blood discard sample will be placed in a red top test tube containing exogenously added
      recombinant human FVIII concentrate [Advate, Baxter immuno] to assure an end concentration of
      once IU per CC of whole blood.

      Both whole blood specimens will be allowed to coagulate at room temperature and then will be
      centrifuged to prepare serum. The separated serum from each type of collection test tubes
      will be aliquoted into eppendorf tubes (a minimum of two aliquots per sample) at a volume of
      150 microliters. Aliquoted serum samples will be stored at -70 degrees centigrade and shipped
      on dry ice to Synarc Labs.

      A panel of standard CTX bone resorption assays will be preformed in duplicate on the two
      differently processed serum specimens obtained from each subject.

      Results will be analyzed for inter-subject variability using stored age-matched samples
      provided by Synarc and intra-subject variability will also be analyzed.
    

Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Severe Hemophilia A
      
Keywords: Severe Hemophilia A; Hemophilia A Patients; Serum collection vs a method of added FVIII to blood samples
Ionized Magnesium for Monitoring of Citrate-anticoagulated CVVHD
Condition: Intensive Care Unit Syndrome
Study type: Observational

Summary: 
      It has been reported in several studies that ionized hypomagnesemia is associated with higher
      morbidity and mortality rates. During continuous renal replacement therapy with regional
      citrate anticoagulation (CRRT-RCA), the loss of magnesium has been reported to not be covered
      by magnesium concentration in ordinary dialysis fluid. This may lead to ionized
      hypomagnesemia. However the incidence of ionized hypomagnesemia in patients requiring
      CRRT-RCA remains unclear and need to be estimated to determine if ionized magnesium
      monitoring could be of interest. This study aim to assess the incidence of ionized
      hypomagnesemia induced by CRRT-RCA.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult patients admitted to the ICU and requiring CRRT-RCA
      
Biospecimen description: 
      NC
    
Keywords: Continuous renal replacement therapy with regional citrate anticoagulation (CRRT-RCA); Ionized hypomagnesemia; Monitoring of ionized magnesemia; Morbi-moratlity
Stroke Minimization Through Additive Anti-atherosclerotic Agents in Routine Treatment
Condition: Atherosclerosis; Adherence, Medication; Tolerance
MeSH terms: Atherosclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The overarching objective of the Stroke Minimization through Additive Anti-atherosclerotic
      Agents in Routine Treatment (SMAART) trial is to assess whether a polypill containing fixed
      doses of (2/3) antihypertensives, a statin and antiplatelet therapy taken once daily orally
      would result in carotid intimal thickness regression-a surrogate marker of atherosclerosis,
      improved adherence, and tolerability compared with 'usual care' group on separate individual
      secondary preventive medications among Ghanaian first time stroke survivors. Our ultimate
      objective is to design of a future multi center, double-blinded, placebo-controlled,
      parallel-group, randomized trial comparing the clinical efficacy of the polypill strategy vs
      'usual care' in the African context to derive locally relevant, high-quality evidence for
      routine deployment of polypill for CVD risk moderation among stroke survivors in LMICs. In
      this current study, we plan to recruit 120 recent ischemic stroke survivors randomized 1:1 to
      the polypill or usual care arms.
    


Intervention name(s): Polycap
Intervention type(s): Drug
Intervention description(s): Assigned to a polypill containing 2/3 antihypertensives, a moderate/high-intensity statin and Aspirin to be taken orally, once daily in the form of a hard capsule
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: SMAART incorporates (i) a pilot randomized controlled trial and (ii) a human capital/institutional capacity building component. We propose a randomized, open label, blinded endpoint clinical trial with the intervention arm assigned to a polypill containing 2/3 antihypertensives, a moderate/high-intensity statin and Aspirin to be taken orally, once daily in the form of a hard capsule compared with the 'usual care' arm who will continue to take separate, individual secondary preventive medications as prescribed their physicians to assess CIMT changes as a robust intermediary outcome measure for CVD events, as well as adherence, tolerability, and risk factor control rates. Furthermore, a cadre of emerging investigators from Ghana will benefit from the rich learning environment to be created through the implementation of the RCT and the interactions (2 years) with experts from the Medical University of South Carolina.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study of MK0777 Gel Extrusion Module (GEM) in the Treatment of Outpatients With Generalized Anxiety Disorder (0777-019)
Condition: Generalized Anxiety Disorder
MeSH terms: Anxiety Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The study will look at the effectiveness of MK0777 in patients with Generalized Anxiety
      Disorder.
    


Intervention name(s): MK0777; Placebo (unspecified)
Intervention type(s): Drug; Drug
Intervention description(s): Days 1-3 3mg MK0777, Days 4-7 6 mg MK0777, Days 8-28 3, 6 or 9 mg MK0777; matching placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
the Effect of Different Mechanical Ventilation Modes on Optic Nerve Diameter and Conscious Functions
Condition: Mechanical Ventilation
Study type: Interventional

Summary: 
      During surgery, researchers use different methods in respiratory equipment. In the study
      researchers examine the effects of these methods on intraocular pressure changes by looking
      at the intraocular nerve diameter. Then look at the effects of these effects on patients
      conscious functions by asking some questions.
    

Detailed description: 
      According to the mechanical ventilator application to be applied to the patients; Group P (n:
      30) pressure controlled ventilation (PCV), Group V (n: 30) volume controlled ventilation
      (VCV) are randomly assigned to two groups. General anesthesia will be applied to all
      patients. Mechanical ventilation settings will be able to 8ml / kg TV (tidal volume).
      Demographic data (age, gender, weight, height) of patients, duration of surgery and
      peroperative complications will be recorded choosen time intervals.T0: awake, T1: 5th min
      after induction, T2: Gas insufflation start in supine position, T3: Maximum gas pressure is
      reached in reverse trendelenburg position, T4:Before extubation. SAB, DAB, OAB, KAH, SpO2,
      Ppeek, PEEP, EtCO2, optic nerve diameter will be recorded at same times. Cognitive function
      test will be performed at postoperative 24th hour for comparing the first awaken routin MMDT
      (Mini Mental Status Detection) scale. The same test will be repeated for patients who are
      called for routine general surgery outpatient control 3 months after surgery.
    

Intervention name(s): The Effect of Different Mechanical Ventilator Modes on Optic Nerve Diameter and Cognitive Functions in Laporoscopic Cholecystectomy Operations
Intervention type(s): Procedure
Intervention description(s): The Effect of Different Mechanical Ventilator Modes on Optic Nerve Diameter and Cognitive Functions in Laporoscopic Cholecystectomy Operations
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: ASA I-II 60 patients aged 18-65 years undergoing laparoscopic cholecystectomy surgery according to mechanical ventilator mode; Group P (n: 30) Pressure controlled ventilation was randomly divided into Group V (n: 30) volume controlled 50% air, PEEP 5 to 8ml / kg tidal volume.
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Optic Nerve Sheath Diameter,; Minimental test
A Study of ND0801 in Attention Deficit/Hyperactivity Disorder (ADHD)
Condition: Attention Deficit and Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      A multicenter, open label, escalating dose study to assess the tolerability and the safety
      and to explore the efficacy and the pharmacokinetics of ND0801 in adult patients with
      attention deficit/hyperactivity disorder (ADHD).
    


Intervention name(s): ND0801
Intervention type(s): Drug
Intervention description(s): Confidential
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Construction of the Training Mode Adjustable Equipment Sitting Volleyball
Condition: Training
Study type: Interventional

Summary: 
      The individual adapted sport modalities concentrate most of the technological development for
      equipment and auxiliary devices, the collective modalities need implements that aid in the
      development of training and the game.
    

Detailed description: 
      The individual adapted sport modalities concentrate most of the technological development for
      equipment and auxiliary devices, the collective modalities need implements that support, in
      the development of training and the game. It was developed equipment to assist in the
      training of technical fundamentals and to improve the efficiency of the motor gesture
      required for the practice of sitting volleyball in athletes with physical disabilities. Ten
      athletes, sitting volleyball players, were selected to perform a set of technical
      fundamentals and their variations. Lift the ball (with two variations), attack and serve, and
      reception. After the analysis of the movements the equipment was elaborated and constructed
      based on the measurements made with the athletes, such as contact height with the ball,
      perimeter, speed and parabola.
    

Intervention name(s): Survey training equipment; Attack and serve training equipment; Pass training equipment
Intervention type(s): Device; Device; Device
Intervention description(s): The survey was checking the equipment designed to assist the lifter training survey with greater precision, in aspects of average height of contact of the ball by striker and maximum perimeter of contact with the ball, for the execution of the attack.; The attack and serve training equipment was designed to assist the athlete in their body positioning for the execution of the fundamentals of the attack and serve, and the correct extension execution of the of trunk, upper limbs and reaction time of contact with the ball.; The equipment for the training of the pass, it was designed to represent the serve forced and technical, variables height, circumference and average speed of the ball. This equipment has been adapted from the conventional volleyball serve equipment, respecting the limits of the sitting volleyball court.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other