bioihbjkbjnl/mcl2 huggingface dataset:
Using Ca-41 Methodology to Assess the Impact of Different Vitamin D Supplementation Levels on Postmenopausal Bone Health
Condition: Osteopenia
MeSH terms: Bone Diseases, Metabolic
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this study is to determine whether increasing levels of serum 25(OH)Vitamin D
      as achieved by oral supplementation higher than the current recommendations are associated
      with a less negative bone calcium balance in post-menopausal Swiss women.
    

Detailed description: 
      In a substudy - not related to the vitamin D intervention - spot and 24 h urine samples are
      compared with regard to the assessment of iodine status in Swiss post-menopausal women.

      In an short subsequent study using five of the subjects who participated in the original
      trial, the effect of a 40 d-exercise program (rebounding on a trampoline) on Ca-41 excretion
      will be observed.
    

Intervention name(s): vitamin D; exercise program (rebounding on a trampoline)
Intervention type(s): Dietary Supplement; Behavioral
Intervention description(s): Vitamin D supplement; 40 days at 30 min/d
Intervention MeSH terms: Vitamin D
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Montelukast in Patients With Seasonal Allergic Rhinitis - Spring 2000 Study (MK-0476A-162)(COMPLETED)
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the ability of montelukast to improve the signs and symptoms of
      seasonal allergic rhinitis compared with loratadine and placebo.
    


Intervention name(s): Comparator: montelukast; Comparator: loratadine; Comparator: placebo; Comparator: montelukast/loratadine
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 10 mg montelukast tablet given once daily at bedtime for 2 weeks; 10 mg loratadine tablet given once daily at bedtime for 2 weeks; placebo tablet given once daily at bedtime for 2 weeks; montelukast 10-mg/loratadine 10-mg combination tablet taken orally once daily at bedtime for 2 weeks
Intervention MeSH terms: Loratadine; Montelukast
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Efficacy of HFNC as an Alternative to CPAP Therapy in Surgical Patients With Suspected Moderate to Severe OSA
Condition: OSA
Study type: Interventional

Summary: 
      High flow, humidified, temperature-regulated nasal insufflation is not a new concept. It is
      used widely in the treatment of hypoxaemic respiratory failure in critically ill patients, as
      an alternative to non-invasive positive ventilation via face or nasal mask. Recently, its use
      has been extended to the perioperative setting for pre-oxygenation and prolonging apnoeic
      time to desaturation. Both CPAP and high flow nasal cannula insufflation devices are licensed
      for use clinically in Singapore. We conduct this pilot study because its perioperative use in
      our adult OSA population is currently not well-defined.
    

Detailed description: 
      Continuous positive airway pressure (CPAP) therapy is the only treatment for obstructive
      sleep apnoea (OSA) shown to reduce its long-term adverse effects on the cardiovascular
      system. However, due to difficult patient-mask interface and discomfort, compliance rate
      amongst patients with OSA is low, and reported to be only between 20-50%. High flow,
      humidified, temperature-regulated nasal cannula insufflation (of air or oxygen) is a
      well-documented and safe treatment in intensive care, paediatrics and respiratory medicine
      for patients with hypoxaemic respiratory failure. Its use in adult patients with obstructive
      sleep apnoea, especially in the perioperative setting is not well studied. Our hospital has a
      ''fast-track'' protocol for OSA patients who require surgery. They are started on CPAP
      therapy 2 to 5 days prior to surgery and in the immediate post operative period (ie.
      perioperatively). If these patients are non-compliant to the CPAP mask device, high flow
      nasal insufflation is a possible alternative treatment. We aim to randomise these patients
      into 4 groups, receiving conventional CPAP face mask or high flow nasal cannula at 3 flow
      rates, and study them with respect to incidence and number of documented desaturations. In
      addition, patient satisfaction, compliance to device and any adverse events will be
      monitored.
    

Intervention name(s): CPAP face mask; High flow nasal cannula (HFNC)
Intervention type(s): Device; Device
Intervention description(s): Two types of CPAP therapy for OSA support are compared; CPAP face mask vs HFNC at different flow rates; Two types of CPAP therapy for OSA support are compared; CPAP face mask vs HFNC at different flow rates
Other intervention name(s): Optiflow™ High Flow therapy; Fisher and Paykel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CPAP therapy; High flow nasal cannula
A Study of the Safety, Tolerability and Pharmacokientics of RO5545965 in Patients With Schizophrenia on Risperidone
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      This randomized, double-blinded, placebo-controlled study will investigate the safety,
      tolerability, and pharmacokinetics of multiple doses of RO5545965 administered orally to
      psychiatrically stable patients with schizophrenia receiving risperidone.
    


Intervention name(s): Placebo; RO5545965; risperidone
Intervention type(s): Other; Drug; Drug
Intervention description(s): Oral daily administration from Days 1-12; Oral daily administration from Days 1-12; 13 day run-in phase until 4 mg daily dose level is reached. 4 mg daily oral dose until Day 17 of study, for a total of 30 days. Dose may be increased up to 6 mg at the investigator's discretion. After study treatment, risperidone dosage may be decreased, increased or omitted at the investigator's discretion during a wash-out phase while patients return to their chronic antipsychotic treatment. Patient response during wash-out will be monitored in-house for 48 hours after the last dose of RO5545965 or placebo is administered. This in-house observation may be extended as needed by the investigator.
Intervention MeSH terms: Risperidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
SPC3649 Multiple Dose Study in Healthy Volunteers
Condition: Hepatitis C
MeSH terms: Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the safety and tolerability of SPC3649 given in
      multiple doses to healthy volunteers.
    


Intervention name(s): SPC3649; saline
Intervention type(s): Drug; Drug
Intervention description(s): 5 weekly doses; 5 weekly doses
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Antisense; miR-122 antagonist; safety in healthy Volunteers; Hepatitis C
Williams Syndrome Strength, Hormones, Activity & Adiposity, DNA Programming, Eating Study
Condition: Williams Syndrome; Lipedema
MeSH terms: Williams Syndrome; Lipedema; Syndrome
Study type: Observational

Summary: 
      Williams syndrome (WS) is a rare microdeletion genetic disorder that has a broad phenotype
      including many endocrine and metabolic abnormalities. Dr. Pober and colleagues at MGH have
      reported the following findings in adults with WS: abnormal body composition (excess body fat
      accumulation with a lipedema phenotype), decreased bone mineral density, abnormal glucose
      tolerance, and reduced lean mass. Despite the high prevalence and potential effect of
      metabolic abnormalities on the health of persons with WS, their full phenotypic range,
      potential causal factors (either genetic and/or hormonal) along with their impact on other
      aspects of health (such as risk of falls and fractures or interaction with emotional
      behavioral concerns) remain incompletely characterized. The purpose of the current study in a
      large cohort of subjects with WS is to: collect further information to characterize the
      timing of onset and distribution of body fat; better characterize hormonal status of WS
      subjects; and screen for genetic variation using single-nucleotide-polymorphism (SNP)
      analysis that could elucidate genetic contributors to the lipedema phenotype as well as the
      other observed metabolic and bone abnormalities.
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Dr. Pober and colleagues plan to include 30 individuals with Williams syndrome (WS) who
        participate at Massachusetts General Hospital, along with 25-30 matched control
        individuals, as well as 50 individuals with WS who participate at conventions related to
        WS, and 100 individuals with WS who participate remotely.
      
Keywords: Williams Syndrome; Lipedema; Body Composition; Glucose; Bone Density
Effect of Prebiotic Fiber- Enriched (scFOS) Enteral Feeding on the Microbiome in Neurological Injury Trauma Patients (PreFEED Microbiome Trial)
Condition: Enteral Nutrition; Brain Injuries, Traumatic; ICU Admission
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Trauma, Nervous System; Wounds and Injuries
Study type: Interventional

Summary: 
      This study plans to learn more about the impact of enteral nutrition on bacteria in
      critically ill trauma patients with brain injury. Specifically, it seeks to understand the
      effect that a prebiotic containing enteral feeding formula (Nutraflora scFOS in Vital AF) has
      on the gut, oral, and skin bacteria. A prebiotic is a special form of dietary fiber that acts
      as a fertilizer for good bacteria. The prebiotic Nutraflora scFOS has been cleared by the
      U.S. Food and Drug Administration and is not considered investigational as used in this
      study. Enteral feeding is a way to give nutrition to critically ill people who are unable to
      eat.
    


Intervention name(s): Nutraflora scFOS; Osmolite
Intervention type(s): Other; Other
Intervention description(s): prebiotic fiber (Nutraflora scFOS via Vital AF); non-prebiotic fiber containing formula (Osmolite)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: trauma; brain; neurological; injury; enteral; tube; feeding; nutrition
The Effect of Vitamin D Supplementation on Cardiovascular Risk Factors
Condition: Vitamin D Deficiency
MeSH terms: Vitamin D Deficiency
Study type: Interventional
Phase: Phase 3

Summary: 
      Six-hundred subjects with vitamin D deficiency will be randomized to vitamin D 3000 IU per
      day versus placebo for 4 months, with effects on cardiovascular risk factors as main endpoint
    

Detailed description: 
      Vitamin D is a hormone with effects not only on the skeleton, but on most tissues in the
      body. Lack of vitamin D is associated with cardio-vascular disease (CVD) and type 2 diabetes,
      and also with risk factors for these diseases like hypertension, dyslipidemia, insulin
      resistance, and endothelial dysfunction. However, intervention studies with vitamin D have
      been inconclusive regarding diseases and risk factors. Most of these studies were done in
      white, Western populations in subjects fairly vitamin D sufficient, and accordingly, no
      benefits were to be expected. Also, in many studies the doses of vitamin D have been too low,
      and the studies underpowered. To firmly establish the role of vitamin D regarding CVD risk
      factors we will in the present study include 600 subjects with vitamin D deficiency (serum
      25-hydroxyvitamin D (25(OH)D) < 30 nmol/L) and randomize to high dose vitamin D (3000 IU per
      day) versus placebo for four months. The subjects will be recruited based on 25(OH)D
      measurements in the forthcoming 7th survey in the Tromsø study where more than 20 000
      subjects are expected to attend. If our hypotheses are correct and the vitamin D supplement
      has a positive effect, this will be of great importance not only in countries with low sun
      exposure, but particularly for subjects in developing countries where vitamin D deficiency is
      highly prevalent.
    

Intervention name(s): Cholecalciferol; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Vitamin D preparation; placebo
Other intervention name(s): Dekristol
Intervention MeSH terms: Cholecalciferol; Vitamin D
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: vitamin D; blood pressure; serum lipids; glucose metabolism; muscle function; arterial stiffness; depression; psoriasis; sleep; bone density
Hemicraniectomy in Patients With Malign Middle Cerebral Artery Infarction
Condition: Cerebral Herniation
MeSH terms: Infarction, Middle Cerebral Artery; Infarction
Study type: Interventional

Summary: 
      This trial is a prospective, randomized, controlled, clinical trial based on a stroke center.
      We randomly assigned 151 patients 41 years of age or older (median, 65 years; range, 41 to
      83) with malignant middle cerebral artery infarction to either conservative medical treatment
      or hemicraniectomy; assignments were made within 12 to 38 hours after the onset of symptoms.
      The primary end point was survival with slight or moderate disability 12 months after
      randomization (defined by a score of 0 to 3 on the modified Rankin scale, which ranges from 0
      [no symptoms] to 6 [death]). Secondary outcome included death, Barthel Index, National
      Institute of Health Stroke Scale, and Stroke Impact Scale 2.0 (SIS) 6 months and 1 year after
      randomization. Variables for subgroup analyses were age, sex, presence of aphasia or neglect,
      stroke severity and time to randomization. The study was performed according to Consolidated
      Standards of Reporting Trials (CONSORT).
    

Detailed description: 
      Patients between 40 to 80 years of age were included within 12 to 38 hours of a malignant
      middle cerebral artery infarction defined by the association of 3 criteria: a National
      Institutes of Health Stroke Scale score ≥16, including a score ≥1 for item 1a (level of
      consciousness); brain computed tomography ischemic signs involving 2/3 of the middle cerebral
      artery territory; and a diffusion-weighted imaging (DWI) infarct volume >150cm3. The first
      patient was enrolled in January 2003 and the last patient in December 2007. An independent
      data safety monitoring committee monitored the safety, progress, and ethics of the trial.
      Patients were randomized to either surgical plus medical treatment or to conservative medical
      treatment alone.
    

Intervention name(s): Hemicraniectomy; Conservative medical therapy
Intervention type(s): Procedure; Other
Intervention description(s): Large hemicraniectomy and duraplasty; Conservative medical therapy was based on published guidelines for the early management of patients with ischemic stroke
Other intervention name(s): Surgical decompression; Control group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: infarction, hemicraniectomy
Safety and Efficacy of Once Daily Topical Treatment With LEO 90100 Aerosol Foam in Adolescent Subjects With Plaque Psoriasis
Condition: Psoriasis Vulgaris
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      An international, multi-centre, prospective, open-label, non-controlled, single-group, 4-week
      trial in adolescent subjects with plaque psoriasis.
    


Intervention name(s): LEO 90100
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effectiveness of Internet Cognitive Behavioral Therapy Intervention for Treating Insomnia
Condition: Sleep Initiation and Maintenance Disorders
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study will evaluate the effectiveness of an online cognitive behavioral therapy
      intervention in improving sleep, mood, and cognitive functioning in people with insomnia.
    

Detailed description: 
      Insomnia is a disorder that is characterized by a perception or complaint of inadequate or
      poor-quality sleep. Symptoms of insomnia include difficulty falling asleep, waking frequently
      during the night and having difficulty returning to sleep, waking too early in the morning,
      and unrefreshing sleep. Insomnia may also cause problems during the day, such as tiredness,
      difficulty concentrating, and irritability. Cognitive behavior therapy (CBT) has been found
      to have significant short- and long-term benefits for people with insomnia. Access to CBT for
      many people, however, is limited, due to the high cost of treatment and a lack of trained
      professionals in some locations. Delivering CBT via the internet could help make the
      treatment more widely available. This study will evaluate the effectiveness of an online CBT
      intervention in improving sleep, mood, and cognitive functioning in people with insomnia.

      Participants in this open label study will be randomly assigned to receive the online CBT
      intervention either immediately or after a 4-month waiting period. Participants will use the
      online program for 1 to 2 hours per week for 8 weeks. Participants will keep track of their
      sleep patterns for the first and last 2 weeks of a 4-month period by keeping a daily diary
      and wearing a wrist watch device that monitors movement. All participants will report to the
      study site for baseline evaluations before beginning treatment and for final evaluations upon
      completing the program, about 4 months after study entry.
    

Intervention name(s): Cognitive behavioral treatment (CBT) delivered over the Internet
Intervention type(s): Behavioral
Intervention description(s): CBT delivered over the Internet for insomnia targets maladaptive behaviors and dysfunctional thoughts that perpetuate sleep problems. Treatment includes through educational, behavioral, and cognitive strategies.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Internet; CBT; Insomnia; Sleep
Auricular Acupuncture in Substance Abuse: Effects on Anxiety, Sleep, Drug Use.
Condition: Substance Abuse; Anxiety; Sleep
MeSH terms: Substance-Related Disorders; Anxiety Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      Background. A common alternative treatment for substance abuse is ear acupuncture. The aim of
      the study was to evaluate the short and long-term effect of auricular acupuncture on anxiety,
      sleep, drug use and addiction treatment utilization in adults with substance abuse. Method.
      Adults with substance abuse and psychiatric comorbidity were randomly assigned to either of
      two variants of auricular acupuncture - The National Acupuncture Detoxification Association
      protocol (NADA) or a local protocol (LP) - or relaxation training (controls). Primary
      outcomes were measured using the Beck Anxiety Inventory (BAI) and Insomnia Severity Index
      (ISI) with assessment before treatment and follow-ups after five weeks and three months.
      Secondary outcomes were drug use and addiction service utilization.
    


Intervention name(s): NADA Acupuncture; LP acupuncture; Relaxation
Intervention type(s): Device; Device; Behavioral
Intervention description(s): NADA-acupuncture was delivered in three phases: (1) one treatment each day during the first of a total of five weeks; (2) three treatments each week during the following two weeks; (3) two treatments each week during the two remaining weeks. each session consisted of approximately 40 minutes with acupuncture at five ear points called Sympathetic, Shen Men, Kidney, Liver and Lung, which are believed to be the best points for substance abuse patients. Acupuncture was administered to both ears using stainless steel needles. NADA-acupuncture were given as a supplement to treatment as usual consisting of Motivational Interview, pharmacological treatment, and control of drug use with urine tests.; The LP-acupuncture was delivered in two phases: (1) three treatments each week during the two first weeks; (2) two treatments each week for two weeks. each session consisted of approximately 40 minutes with acupuncture at five ear points called Sympathetic, Shen Men, Kidney, Liver and Lung, which are believed to be the best points for substance abuse patients. Acupuncture was administered to both ears using stainless steel needles. LP-acupuncture were given as a supplement to treatment as usual consisting of Motivational Interview, pharmacological treatment, and control of drug use with urine tests.; Relaxation consisted of listening to soft music in a quiet room with dampened light and was delivered to match the amount and phases of the LP-acupuncture. Relaxation were given as a supplement to treatment as usual consisting of Motivational Interview, pharmacological treatment, and control of drug use with urine tests.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment