bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy of ORM-12741 on Agitation/Aggression Symptoms in Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease; Aggression
Study type: Interventional
Phase: Phase 2

Summary: 
      This study evaluates the effect of ORM-12741 on agitation/aggression symptoms in Alzheimer's
      disease. Two thirds of the patients will receive ORM-12741 and one third will receive
      placebo.
    

Detailed description: 
      ORM-12741 is a potent and selective alpha-2C adrenoceptor (AR)-antagonist. Previous results
      suggest that the compound may have positive effects on both cognitive and neuropsychiatric
      symptoms of Alzheimer's Disease. In this study, the effect of ORM-12741 will be evaluated on
      agitation/aggression symptoms and other neuropsychiatric symptoms. Furthermore, cognition and
      psychotic and depressive symptoms will be evaluated.
    

Intervention name(s): ORM-12741; ORM-12741; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): ORM-12741 low dose twice a day; ORM-12741 high dose twice a day; Placebo twice a day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Oxytocin Levels in Typically Developing Boys
Condition: Healthy Boys
Study type: Observational

Summary: 
      Measuring basal levels of plasma oxytocin in individuals with typical development across
      childhood and adolescence using both extracted and unextracted EIA methods.
    

Detailed description: 
      Measuring basal levels of plasma oxytocin in individuals with typical development across
      childhood and adolescence using both extracted and unextracted EIA methods. This study is
      necessary since there is great variability in reported plasma oxytocin in typically
      developing children from other studies as well as up to 1000 fold variability in such levels
      using different assay procedures. Further existing studies have not clearly described
      variation in levels with age. all samples will be taken in the afternoon.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        This population will be a community sample representative of the community of the area.
      
Keywords: healthy boys; plasma oxytocin; pediatric
Safety, Tolerability and Pharmacokinetic Investigation of GSK3882347 in Healthy Participants.
Condition: Urinary Tract Infections
MeSH terms: Urinary Tract Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase 1, 2-part, double-blind (sponsor-unblinded), randomized, placebo-controlled,
      first time in human (FTIH) study, that includes both single-ascending and multiple-ascending
      dose phase to assess the safety, tolerability, and pharmacokinetics (PK) of GSK3882347 in
      healthy adult men and Woman of Non Childbearing Potential (WONCBP). Part 1 will be the single
      ascending dose (SAD) phase and Part 2 will be the multiple ascending dose (MAD) phase. Each
      participant in the SAD cohort will receive a single dose of GSK3882347 or placebo (PBO) in
      3:1 ratio and in Part 2 (MAD), participants will be randomized in a 4:1 ratio to receive
      active treatment and placebo. Part 1 will consist of two cohorts with a maximum of
      four-period for each cohort, the food effect evaluation will be conducted in last period
      (Period 4) in only one of the cohorts based on the observed human pharmacokinetics (PK). Part
      2 will consist of maximum of four cohorts for each of the MAD dose or placebo.
    


Intervention name(s): GSK3882347; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Capsule of 10-200mg dose strength will be provided in labelled High Density Polyethylene (HDPE) bottles.; Matching strength placebo capsules will be provided
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Part 1 will consist of two cohorts (Cohorts 1 and 2) with a maximum of four periods in a cross-over design conducted in two separate cohorts. Part 2 consists of a maximum of four ascending repeat-dose cohorts (Cohorts 3 to 6) for which participants, will receive a single oral dose of GSK3882347 or placebo for 7 days.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: SAD; MAD; FTIH; Pharmacokinetics; Urinary Tract Infections; GSK3882347
Glucose Metabolism in the Immediate and Short Term Follow up After Bariatric Surgery
Condition: Diabetes; Gastric Bypass
Study type: Interventional
Phase: Phase 1

Summary: 
      MIDAS involves an assessment of glucose levels obtained before and after bariatric surgery.
      There are two different procedural tests involved; an oral glucose tolerance test (mixed
      meal) and a hyperglycemic clamp test. Two tests are performed preoperatively and five more
      are performed postoperatively for a one year period. The associated labwork drawn with the
      mixed meal and clamp tests are demonstrating changes in glucose, insulin and gut hormone
      levels.
    

Detailed description: 
      Tests performed are the Mixed Meal tolerance test, the Hyperglycemic Clamp test, c-peptide,
      free fatty acids, adipocyte hormone profile levels.
    

Intervention name(s): Mixed Meal Tolerance test, Hyperglycemic clamp
Intervention type(s): Procedure
Intervention description(s): Subjects undergo a standard mixed meal tolerance test & hyperglycemic clamp to assess insulin secretion & sensitivity (whole body glucose disposal) pre-op. Following surgery, at 1week, 1 month, 6 months and 12 months subjects will undergo hyperglycemic clamp & mixed meal tolerance test. During these tests, measurements will include plasma levels of glucose, insulin, C-peptide, free fatty acid levels and adipocyte hormone profile (adiponectin, leptin, resistin). A gut hormone profile (ghrelin, glucagons-like-peptide 1 GLP-1, glucose-dependent insulinotropic polypeptide GIP, PYY) will be performed at fasting & specific postprandial times. Results will be compared between two groups: patients undergoing laparoscopic Roux-en-Y gastric bypass & gastric banding.
Other intervention name(s): MMTT
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Keywords: diabetes; MIDAS; gut hormones; gastric bypass; lap band
The Role of Sleep in the Treatment of Cannabis Use Disorders
Condition: Drug Addiction
MeSH terms: Substance-Related Disorders
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The number of people seeking treatment for marijuana-related problems is on the rise, yet
      there is no currently accepted medication proven to help them quit. Frequent marijuana users
      have reported that they have trouble sleeping when they try to quit, and that the loss of
      sleep can lead to relapse. This research is designed to measure the severity of sleep
      problems in people as they are trying to quit heavy use of marijuana, and to investigate
      whether extended-release zolpidem (Ambien CR®) can improve quit rates among people trying to
      stop using marijuana.
    


Intervention name(s): Zolpidem extended-release; MET/CBT
Intervention type(s): Drug; Behavioral
Intervention description(s): nightly administration of zolpidem extended-release; a standardized 12-week therapy consisting of motivational enhancement therapy (MET) and cognitive behavior therapy (CBT) for treating cannabis use disorders will be administered to all study participants
Other intervention name(s): Ambien CR
Intervention MeSH terms: Zolpidem
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: marijuana; cannabis; treatment; insomnia; relapse
3 Formulations of Hib-MenCY-TT Vaccine & 1 Formulation of Hib-MenC-TT Vaccine Compared to Licensed Meningococcal Serogroup C Conjugate Vaccine, Each Administered at 2,3,4 Mths of Age
Condition: Haemophilus Influenzae Type b; Neisseria Meningitidis
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      This study evaluated the safety and immunogenicity of 3 formulations of Hib-MenCY-TT vaccine
      and 1 formulation of Hib-MenC-TT vaccine compared to a control group receiving licensed
      meningococcal serogroup C conjugate vaccine, each administered at 2, 3, and 4 months of age.
      Antibody persistence and immune responses to booster vaccinations were additionally assessed
      at 12 to 18 months of age.
    

Detailed description: 
      Primary & booster vaccination study to evaluate the immuno,reacto & safety of 3 diff.
      formulations of GSKBio'combined Haemophilus influenzae typeb-meningococcal serogroups C &
      Y-conjugate vaccine & one formulation of GSKBio' Haemophilus influenzae typeb-meningococcal
      serogroup C conjugate vaccine each given concomitantly With Infanrix penta (DTaP-IPV-HepB
      vaccine), vs Meningitec meningococcal SerogroupC conj.vaccine) given concomitantly With
      Infanrix hexa (DTaP-IPV-HepB-Hib vaccine) in infants according a 2-3-4 mth schedule
    

Intervention name(s): Hib-MenCY-TT vaccine; Hib-MenC-TT vaccine; Menjugate ®; Infanrix penta ®; Infanrix hexa ®
Intervention type(s): Biological; Biological; Biological; Biological; Biological
Intervention description(s): Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in left thigh.; Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in left thigh.; Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in left thigh.; Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in right thigh.; Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in right thigh.
Other intervention name(s): DTPa-HBV-IPV vaccine; DTPa-HBV-IPV/Hib vaccine
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Invasive bacterial disease caused by Hib; Neisseria meningitidis serogroups C & Y
Pediatric Population Screening for Type 1 Diabetes and Familial Hypercholesterolemia in Lower Saxony, Germany
Condition: Type 1 Diabetes; Familial Hypercholesterolemia
MeSH terms: Hyperlipoproteinemia Type II; Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypercholesterolemia
Study type: Observational

Summary: 
      This is a Pilot/ feasibility study for a population-based Screening in all children 2 to 6
      years in Lower Saxony, Germany during the compulsory (U7 (from the age of 2) U7a, U8, U9)
      routine check-ups and any voluntary visits to the pediatricians office.
    

Detailed description: 
      The Fr1dolin-Study will be presented to the parents of ca. 320,000 children living in Lower
      Saxony, Germany. The recruitment of subjects, collection of written consent, the capillary
      blood sample and the screening questionnaire will be done by the registered pediatricians in
      their local medical practices.

      After study enrolment 200 µl of capillary blood are be taken from the subject and are sent
      pseudo-anonymized to the lab. LDL-C and the diabetes-associated antibodies are identified.
      Based on the results a second blood sample will be required. In case of pre-type-1 diabetes
      or signs for a familial hypercholesterolemia the pediatrician will be informed. He will
      contact the parents and discuss the further procedure in cooperation with the study center.

      In case of a positive result by measuring diabetes-related antibodies and LDL-C the goal of
      this trial is to advise and educate the families appropriate and to treat them if necessary.
      In addition families should have the possibility to participate in prevention trials.

      All data will be registered in a study database.

      Follow-up pre-type 1 diabetes:

      During the first year, follow-up will be performed after 6 and 12 months and thereafter
      annually until the age of 12 years or up to 6 months after the clinical onset of type 1
      diabetes.

      Follow-up familial hypercholesterolemia:

      During the first year, follow-up will be performed after 6 and 12 months and thereafter
      annually until the age of 12 years.
    

Observational model: Ecologic or Community
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        According to the Federal Statistical Office (31.12.2014) 320.000 children in the age of 2
        to 6 years are living in lower Saxony, Germany. Based on the Fr1da experience a
        participation rate of 25-35 % is expected. The current estimated prevalence of FH und T1D
        of 1:300 leads to the expected number of 450 newly identified cases of FH and T1D in each
        case in the period of 18 months. Additional subjects with FH would be identified by cascade
        screening.
Sleep, Blood Pressure and Vascular Health
Condition: Blood Pressure; Sleep
Study type: Interventional

Summary: 
      The investigators hypothesize that chronic insufficient sleep is associated with diminished
      endothelium-dependent nitric oxide-mediated vasodilation and endothelial tissue-type
      plasminogen activator release in adults with elevated blood pressure. Furthermore, the
      investigators hypothesize that the postulated diminishment in endothelial vasodilator and
      fibrinolytic function with insufficient sleep will be due, at least in part, to increased
      oxidative stress. Furthermore, increasing sleep duration and improving sleep quality will
      increase both endothelium-dependent nitric oxide-mediated vasodilation and endothelial
      tissue-type plasminogen activator release in adults with elevated blood pressure. Increases
      in endothelial vasodilator and fibrinolytic function will be due, at least in part, to
      reduced oxidative stress.
    


Intervention name(s): Targeted Sleep Intervention
Intervention type(s): Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Telecoaching Plus a Portion Control Device for Weight Management in the Primary Care Setting
Condition: Obesity
Study type: Interventional

Summary: 
      The purpose of this study was to evaluate the impact of telecoaching conducted by a counselor
      trained in motivational interviewing paired with a portion control device for obese patients
      receiving care in a certified patient-centered medical home. The investigators will conduct a
      randomized, controlled clinical trial evaluating the effectiveness of a telecoaching
      intervention with a portion control device.
    

Detailed description: 
      The intervention will be provided during a 3-month period with follow-up through 6 months
      after randomization. Body mass index (BMI) and waist circumference measurements will be
      collected at baseline and at 6, 12, 18, and 24 weeks. Participants will also complete
      measures assessing eating behaviors and physical activity at baseline and at 12 and 24 weeks.
    

Intervention name(s): Telecoaching plus Plate; Usual Care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): A wellness coach proactively contacted the participants every two weeks during treatment, using motivational interviewing. In addition, she provided a portion control plate.; Subjects were provided with institutional pamphlets on healthy eating and exercise habits
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Zolpidem or Exercise for Insomnia?
Condition: Chronic Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Introduction: The prevalence of chronic insomnia in the general population is between 10 and
      15%. The therapy commonly prescribed for its treatment is pharmacological, however, there are
      several non-pharmacological alternatives being studied, among them physical exercise.
      Although some studies have described the effect of exercise on sleep in insomnia, there are
      no studies comparing exercise and drugs in the treatment of chronic insomnia, or its effect
      as coadjuvant therapy.

      Objective: To compare the acute and chronic effects of aerobic exercise and zolpidem on sleep
      quality, mood and quality of life in patients with chronic insomnia.

      Material and Methods: 30 patients with chronic insomnia will be randomly assigned into two
      groups: EXERCISE (n=15) or ZOLPIDEM (n=15). The patients of EXERCISE group will be included
      in an aerobic exercise program, performed in 50% of reserve heart rate, on a treadmill (50
      minutes, 3 times/week), during 6 weeks. The ZOLPIDEM group will be treated with zolpidem
      (10mg/night) during 6 weeks. Polysomnography, actigraphy, sleep diary and questionnaires will
      be used the evaluate sleep pattern. Mood and quality of life will be investigated by POMS and
      SF-36 questionnaires.

      Hypothesis: Considering previous studies have demonstrated positive effects of aerobic
      exercise in the insomnia symptoms, the hypothesis of this study is that aerobic exercise,
      performed at moderate intensity, can control the symptoms of chronic insomnia similarly to
      pharmacological therapy.
    


Intervention name(s): Zolpidem; Exercise
Intervention type(s): Drug; Behavioral
Intervention description(s): The ZOLPIDEM group will be treated with zolpidem 10mg/night; The EXERCISE group will participate in an aerobic exercise program, performed in intensity relative to 50% of reserve heart rate, on a treadmill.
Intervention MeSH terms: Zolpidem
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Exercise; Zolpidem; Sleep
Modafinil in Cancer Related Fatigue
Condition: Cancer Related Fatigue; Quality of Life
MeSH terms: Fatigue
Study type: Interventional
Phase: Phase 3

Summary: 
      Cancer related fatigue (CRF) is a highly prevalent and highly significant entity among
      patients with cancer. 'Cancer related fatigue' is not a simple symptom, but is an entity in
      itself, in that it is different from routine fatigue. Cancer related fatigue is that fatigue
      which persists even after rest and has significant effects on quality of life.

      The incidence of Cancer Related Fatigue (CRF) increases during radiation therapy (RT), with
      almost every patient on radiotherapy complaining of at-least some magnitude of fatigue.

      Given that fatigue can affect treatment adherence by patients, it is important to initiate
      measures to either prevent or mitigate Cancer Related Fatigue.

      The investigators intend to use modafinil in cancer related fatigue, in view of the fact that
      it has safety and efficacy in other diseases such as narcolepsy, multiple sclerosis and
      fibromyalgia. In addition, there have been a few small trials which have hinted towards
      benefit with the use of modafinil in cancer related fatigue.

      The investigators have chosen a dose of 100mg/day in the morning, to be compared with
      placebo. The study arm and the placebo arm will be stratified with respect to age, sex,
      disease site, baseline performance status.

      Primary outcome would be fatigue, which will be assessed by the use of Brief Fatigue
      Inventory (BFI). Secondary outcomes include Quality of Life, improvements in performance
      status, changes in systolic and diastolic blood pressure, and changes in weight.
    


Intervention name(s): Modafinil; Pyridoxine
Intervention type(s): Drug; Drug
Intervention description(s): Tablet Modafinil 100mg (Generic) to be given in 100mg once a day dose, at 8AM daily in the morning, and to be given from Day 1 of Radiation Therapy till the first post treatment follow-up; Tablet Pyridoxine 10mg once a day at 8AM daily, from Day one of RT till first post-treatment followup. Tab Pyridoxine 10mg has been chosen as placebo as it resembles Tab Modafinil 100mg in physical appearance, size and shape. Tab Pyridoxine is unlikely to affect Cancer Related Fatigue on its own as all patients on RT are already on multivitamin supplements as per our institutional guidelines.
Intervention MeSH terms: Pyridoxine; Modafinil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Supportive Care
Keywords: Cancer related fatigue; Quality of life; Modafinil; Radiation therapy; Radiotherapy
Intravenous Autologous Bone Marrow-derived Stem Cells Therapy for Patients With Acute Ischemic Stroke
Condition: Acute Stroke
MeSH terms: Stroke; Ischemic Stroke
Study type: Interventional
Phase: Phase 2

Summary: 
      A multi-centric initiative to study safety,feasibility and efficacy of using intravenous
      autologous bone marrow mononuclear cells(BMMC) in patients with acute ischemic stroke.This
      phase of study is visualised as phase 2 study and will aim to determine dose response
      gradient of stem cell therapy and to explore if there is favorable risk to benefit ratio for
      autologous stem cell therapy in patient with acute ischamic stroke.
    

Detailed description: 
      This phase of the study will have two arms developed through random allocation: one arm for
      intravenous autologous bone marrow derived stem cell/mononuclear cells(BMMC arm); and second
      control arm. Patients with acute ischaemic stroke between 7-30 days after onset with moderae
      severity in sable condition will be entered into the study after informed consent. Both arms
      will receive standard treatment but BMMC arm will,in addition,have bone marrow aspiration and
      receive autologous 30-500 million bone marrow mononuclear cells intravenously on the day of
      randomisation and all patients will be followed at DaY 7 ± days, Day 90(-7 days to +14 days),
      Day 180(-7 days to +28 days)and Day 365 (-7 days to + 28 days). A number of safety and
      efficacy variables will be measured. This phase 2 study will aim to determine dose response
      gradient of stem cell therapy and to explore if results have a favourable risk to benefit
      ratio to justify a phase 3 study. This will be the first human trial to determine and compare
      favourable and unfavourable effects of bone marrow mononuclear cells(mainly CD34) in acute
      ischamic stroke and also the first multi-centric study with potential to achieve a reasonable
      sample size in a relatively short time.
    

Intervention name(s): Autologous bone marrow stem cell
Intervention type(s): Biological
Intervention description(s): Autologous bone marrow stem cell have bone marrow aspiration and receive 30-500 million bone marrow mononuclear cells intravenously on the day of randomization.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acute ischemic stroke