bioihbjkbjnl/mcl2 huggingface dataset:
Mechanisms of Pharyngeal Collapse in Sleep Apnea, Study B
Condition: Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes
Study type: Interventional

Summary: 
      In obstructive sleep apnea (OSA), the upper airway recurrently closes during sleep. The
      mechanisms that lead to airway closure are not completely understood. Some studies have shown
      that there is progressive narrowing of the pharyngeal airway across breaths during expiration
      (Progressive Expiratory Narrowing, PEN) preceding an obstructive apnea. The cause of PEN is
      unknown. The investigators will test if lung volumes and low respiratory drive play a role in
      PEN.
    

Detailed description: 
      The mechanisms that lead to airway closure in OSA are not completely understood. Some studies
      have shown that there is progressive narrowing of the pharyngeal airway across breaths during
      expiration (Progressive Expiratory Narrowing, PEN) preceding an obstructive apnea.

      The investigators will test if lung volumes and low respiratory drive play a role in PEN. To
      this end, the investigators will visualize the pharynx of sleep apnea patients during sleep
      using a thin endoscope during sleep while simultaneously measuring lung volumes, genioglossus
      electromyogram, and pharyngeal pressure during flow-limited breaths. Flow limitation will be
      induced by sustained reductions of continuous positive airway pressure (CPAP).
    

Intervention name(s): Induction of flow limitation
Intervention type(s): Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Sleep Apnea; Pathophysiology
Bioequivalence Study of Loratadine Orally Disintegrating Tablets 10 mg Under Fed Conditions
Condition: Healthy
MeSH terms: Disease
Study type: Interventional

Summary: 
      To compare the single-dose oral bioavailability of loratadine 10 mg orally disintegrating
      tablets of Ohm Laboratories Inc (A subsidiary of Ranbaxy Pharmaceuticals, Inc. USA) with
      Claritin® Reditabs® (containing loratadine 10 mg) of Schering-Plough Healthcare Product Inc.,
      USA in healthy, adult, human male subjects under fed condition.
    

Detailed description: 
      The study was conducted as an open label, balanced, randomized, two-treatment,
      two-sequence,two-period, single-dose, crossover, bioavailability study on loratadine
      formulation comparing loratadine 10 mg orally disintegrating tablets of Ohm Laboratories,
      Inc. (A subsidiary of Ranbaxy pharmaceuticals Inc. USA) with Claritin® Reditabs® 10 mg Tablet
      (containing loratadine 10 mg) of Schering- Plough Healthcare Product Inc, USA. in healthy,
      adult, male, human subjects under fed condition.

      A single oral dose of loratadine 10 mg orally disintegrating tablets was administered under
      low light condition during each period of the study under supervision of a trained medical
      officer.

      Subjects were instructed to completely dissolve the tablet on the tongue before swallowing
      the saliva and then, 240 mL of water was administered 30 seconds after drug administration.

      During the course of the study safety parameters assessed were vital signs, clinical
      examination, medical history and clinical laboratory safety tests (hematology, biochemical,
      serology parameters and urine analysis) at base line. Laboratory parameters of hematology and
      biochemistry were repeated at the end of the study.

      A total of 80 subjects were randomized to receive single oral dose of Loratadine 10mg and
      Subjects were admitted in two groups of equal size. Group I: 1-40 Group II: 41-80 70 subjects
      completed both the periods of the study.
    

Intervention name(s): loratadine 10 mg orally disintegrating
Intervention type(s): Drug
Intervention MeSH terms: Loratadine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: bioequivalence loratadine 10 mg orally disintegrating; tablets fed conditions
Vascular Effects of Triglyceride-rich Lipoproteins
Condition: Postprandial Period; Lipemia; Vasodilation; Vascular Resistance; Nitric Oxide
MeSH terms: Hyperlipidemias
Study type: Interventional

Summary: 
      Many types of cardiovascular disease begin when the layer of cells lining blood vessels
      (endothelial cells) start to function abnormally. This causes white blood cells (monocytes)
      to enter the blood vessel wall and eventually form lesions. Fats from foods we consume are
      carried in the blood for 3-8 hours after a fatty meal in small particles known as
      chylomicrons (CM) and chylomicron remnants (CMR). The overall aim of this project is to
      investigate the idea that n-3 polyunsaturated fatty acids (PUFA) protect against heart
      disease by modifying the effect of CMR on endothelial cells and monocytes. We hypothesize
      that n3-PUFA carried in CMR reduce detrimental events which promote blood vessel damage and
      activate protective mechanisms to improve the function of arteries.
    


Intervention name(s): High-fat meals varying in their fatty acid composition
Intervention type(s): Dietary Supplement
Intervention description(s): 70 g fat incorporated into a muffin and milkshake meal, consumed following fasting baseline measurements
Other intervention name(s): DHASCO; Purified fish oil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: n-3 PUFA; Endothelial cells; Nitric oxide; Oxidative stress; Blood pressure; Vasodilation; Lipemia; Unsaturated dietary fats
Absolute Bioavailability of BMS-626529 After Oral and Intravenous Dosing
Condition: Infection, Human Immunodeficiency Virus
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      A phase I absolute bioavailability study of BMS-626529 following oral and intravenous dosing
    


Intervention name(s): BMS-663068; BMS-626529
Intervention type(s): Drug; Drug
Intervention description(s): Single oral dose of BMS-663068; Single intravenous dose of [13C]BMS 626529
Intervention MeSH terms: Fostemsavir
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Ibudilast for the Treatment of Alcohol Use Disorder
Condition: Alcohol Use Disorder
MeSH terms: Alcoholism; Alcohol Drinking
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is a double-blind, placebo-controlled randomized clinical trial of IBUD (50mg BID)
      for the treatment of Alcohol Use Disorder (AUD). Eligible participants will undergo a 12-week
      medication treatment period and 5 in-person visits over 16 weeks.
    

Detailed description: 
      The study design consists of a 12-week, double-blind, placebo-controlled randomized clinical
      trial of IBUD (50mg BID) for the treatment of Alcohol Use Disorder (AUD). The investigators
      will randomize 132 treatment-seekers with current AUD over the course of 4 years. As a
      behavioral support platform, all participants will complete the NIAAA-developed and
      computer-delivered program "Take Control" during the study. Participants will complete
      telephone screening, followed by in-person eligibility assessment, a physical exam for
      medical eligibility, randomization to study medication or matched placebo, and in-person
      follow-up visits at 4, 8, and 12 weeks of treatment. TLFB assessment of drinking outcomes
      will also occur by telephone on weeks 2, 6, and 10. A final safety check visit will occur on
      week 16, consisting of repeated clinical labs and ECG.
    

Intervention name(s): Ibudilast; Placebo oral capsule
Intervention type(s): Drug; Drug
Intervention description(s): targets neurotrophin signaling and neuroimmune function; matched to active drug, ibudilast
Other intervention name(s): Pinatos; MN-166; Sugar Pill
Intervention MeSH terms: Ibudilast
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two-Arm, Randomized, Double-Blind, Placebo-Controlled
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: ibudilast, treatment, medication development
Determination of the Predictive Factors in the Reversibility or the Aggravation in the Disorders of the Glucose Metabolism in Cystic Fibrosis Patients
Condition: Diabetes in Cystic Fibrosis Patients
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional

Summary: 
      For some years, the investigators observe an increase of the arisen of diabetes in cystic
      fibrosis patients However, this diabetes may be reversible. The investigators speak about "
      Cystic fibrosis related diabetes.". The objective of this project, is to know better what
      facilitates the appearance and the reversibility of the diabetes, such as the genetic
      mutations, the respiratory state and the lung infections. Theses knowledges should allow to
      adapt the screening of diabetes, and its treatment, for the patients affected by cystic
      fibrosis.
    


Intervention name(s): Prospective cohort with an annual follow-up
Intervention type(s): Other
Intervention description(s): Annualfollow-up including :
oral glucose tolerance test
dietary survey
biological evaluation
bacteriological and respiratory measures
dual-energy x-ray absorptiometry
physical activity survey
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Cystic fibrosis -diabetes - glucose tolerance - reversibility - oral glucose tolerance test - predictive factors
Human Papilloma Virus (HPV) Vaccine Trial in Young Adolescent Women With GlaxoSmithKline Biologicals' (GSK Bio) HPV-16/18 Vaccine
Condition: Cervical Intraepithelial Neoplasia; Papillomavirus Infection
MeSH terms: Papillomavirus Infections; Neoplasms; Uterine Cervical Dysplasia
Study type: Interventional
Phase: Phase 3

Summary: 
      This protocol posting deals with objectives & outcome measures of the extension phase up to
      Month 48. The objective of the extension study is to evaluate the long-term immunogenicity of
      the HPV 16/18 L1 VLP AS04 vaccine (for all subjects in the HPV Vaccine Group) by
      enzyme-linked immunosorbent assay (ELISA). The objectives & outcome measures of the primary
      phase are presented in a separate protocol posting (NCT00196924).

      The long-term follow-up study will be blinded until the primary study is unblinded and will
      be open for all visits subsequent to unblinding of primary study HPV-013 (NCT00196924).
      During the open phase, only subjects who received the HPV-16/18 VLP/AS04 vaccine during the
      primary study will continue their participation in the follow-up study until Month 48.
      Subjects in the Control group (Havrix®) will attend one further visit as their last study
      visit.

      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep
      2007.
    


Intervention name(s): GSK Biologicals' HPV-16/18 Vaccine (Cervarix™); Havrix™
Intervention type(s): Biological; Biological
Intervention description(s): Three doses of vaccine administrerd intramuscularly according to 0, 1, 6 month schedule; Three doses of vaccine administrerd intramuscularly according to 0, 1, 6 month schedule.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Prophylaxis HPV-16/18 infections and cervical neoplasia
Epidural Steroids With Intrathecal Nalbuphine for Lower Abdominal Oncologic Surgery
Condition: Lower Abdominal Oncologic Surgery
Study type: Interventional

Summary: 
      Intraoperative pain, nausea, vomiting, hypotension, bradycardia are known side effects during
      lower abdominal surgery under spinal anesthesia, Time to 2 segment regression of sensory
      block and duration of effective analgesia prolonged with intrathecal (IT) 0.4 mg nalbuphine &
      IT 0.8 mg nalbuphine, but the incidence of side-effects was significantly higher with IT 0.8
      mg nalbuphine compared with (IT) 0.4 mg nalbuphine.
    

Detailed description: 
      So, the hypothesis of using IT nalbuphine mid away dose 0.6 mg between the best
      intraoperative analgesic effective dose 0.8 mg and the least side effect producing dose 0.4mg
      with the addition of epidural dexamethasone could augment the postoperative analgesia and
      reduce the unwanted side effects. Epidural dexamethasone in a full dose of 8 mg is probably
      more effective than lower doses to control moderate to severe post-operative pain.
      Dexamethasone 8mg dose is surgically safe neither produced delayed wound healing nor elevated
      blood glucose level.
    

Intervention name(s): Placebo-nalbuphine; Dexamethasone-nalbuphine
Intervention type(s): Drug; Drug
Intervention description(s): Epidural injection of normal saline followed with intrathecal injection of 0.6 mg nalbuphine in conjunction with 4 ml of hyperbaric bupivacaine 0.5%; Epidural injection of dexamethasone followed with intrathecal injection of 0.6 mg nalbuphine in conjunction with 4 ml of hyperbaric bupivacaine 0.5%
Intervention MeSH terms: Dexamethasone; Nalbuphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Other
The Relationship Between Nocturnal Enuresis And Spina Bifida Occulta
Condition: Enuresis, Nocturnal; Spina Bifida
MeSH terms: Spinal Dysraphism; Spina Bifida Occulta; Enuresis; Urinary Incontinence; Nocturnal Enuresis
Study type: Observational [Patient Registry]

Summary: 
      It is claimed that SBO may be responsible for bladder dysfunction in patients without known
      neurological disease. Subsequently, it was reported that the frequency of SBO in NE cases was
      higher than normal children. However, in controlled trials, SBO frequency was not different
      in NE patients compared to the normal population. Conversely, the incidence of dysfunctional
      bladder in the presence of SBO in NE patients was found to be higher and the response to
      treatment was worse than in non-SBO patients.

      The present study aimed to determine whether the frequency of SBO in patients with NE was
      higher than in healthy subjects, the effect of SBO on the severity of LUTS and whether
      treatment response of primary NE patients changed in the presence of SBO.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients aged 6 to 15 years who were admitted to an urology outpatient clinics with at
        least one night-time wetting weekly, were included in this prospective study.

        The control group consisted of patients who were admitted to the urology outpatient clinic
        with a complaint of abdominal or lateral pain, who had no NE and had a direct abdominal
        x-ray examination. The patients who were selected as the control group had night wetness
        questioned and the dysfunctional voiding symptom score (DVSS) form was completed. Those who
        had night wetting, neurological disease or diabetes mellitus were not included in the
        control group.
      
Keywords: lower urinary tract symptoms; nocturnal enuresis; spina bifida occulta; treatment response
A Study to Evaluate the Safety, Tolerability and Efficacy of AIN457 in Patients With Relapsing-remitting Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The study will assess the long-term safety and tolerability of AIN457 in patients with
      relapsing-remitting multiple sclerosis (RRMS). In addition the long-term pattern of
      maintenance of efficacy and health related quality of life will be explored.
    


Intervention name(s): AIN457; AIN457
Intervention type(s): Drug; Drug
Intervention description(s): (10mg/kg i.v.).; (10mg/kg i.v.).
Other intervention name(s): AIN457 core/ AIN extension; AIN Placebo / AIN Extension
Intervention MeSH terms: Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Multiple Sclerosis,; demyelinating autoimmune diseases,; interleukin-17,; monoclonal human antibody
Staccato Loxapine Pulmonary Safety in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this trial is to assess the pulmonary safety of 2 inhaled doses of Staccato
      Loxapine within a day.
    

Detailed description: 
      The planned study is a multiple dose, double-blind, placebo-controlled, randomized,
      2-sequence, 2-period crossover study investigating pulmonary safety in healthy volunteers.
    

Intervention name(s): Inhaled Placebo; Inhaled Loxapine
Intervention type(s): Drug; Drug
Intervention description(s): Inhaled Staccato Placebo, 2 inhalations, 8 hours apart; Inhaled Staccato Loxapine, 10 mg doses x 2, 8 hours apart
Intervention MeSH terms: Loxapine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Healthy volunteers
Sustaining Training Effects Through Physical Activity
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      This randomized control trial will investigate whether the implementation of a telecoaching
      program, initiated during pulmonary rehabilitation, is able to increase and maintain physical
      activity and general benefits until six months after rehabilitation discharge.

      After three months of pulmonary rehabilitation (3 times a week), patients with COPD will be
      randomized to either an intervention group which receives an additional telecoaching program
      on top of the pulmonary rehabilitation, or to the usual care group, which only receives
      rehabilitation program. Apart from the added telecoaching program to the intervention group,
      the rehabilitation program will be identical and last for another three months (2 times a
      week). After discharge, both groups will be followed up for six months.
    


Intervention name(s): Telecoaching; pulmonary rehabilitation
Intervention type(s): Behavioral; Other
Intervention description(s): Pedeometer based goals and telecoaching support; Conventional pulmonary rehabilitation along the ATS-ERS guidelines, total duration 6 months.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Physical activity; Pulmonary rehabilitation; COPD
Type 1 Diabetes Telemedicine
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      At the conclusion of this project, investigators will have assessed the effectiveness of
      home-based telemedicine for improving multiple important clinical and patient-centered
      outcomes in a high-risk pediatric cohort with T1D.

      Aim 1. To test the hypothesis that home-based telemedicine is a feasible and acceptable
      method of care delivery for patients with poorly controlled type 1 diabetes (T1D) currently
      cared for at the University of California, Davis (UCD) Pediatric Endocrinology clinic.
      Specifically:

      A) Patients and families choose to participate in telemedicine visits as a supplement to
      in-person care; B) Patients and families can utilize secure, internet-based platforms to
      upload and share glucose meter data and to establish an audio-video connection with a
      diabetes specialist in their home settings; C) Patients and families are satisfied with the
      experience of home-based telemedicine and would choose to receive future diabetes care via
      this modality.

      Aim 2. To test the hypothesis that using home-based telemedicine, these patients can complete
      more frequent visits with a diabetes specialist than they previously completed via office
      visits alone.

      Aim 3. To test the hypothesis that increased contact with a diabetes specialist via
      home-based telemedicine will lead to significant improvement in glycemic control for these
      patients.

      Aim 4. To evaluate the effects of increased contact with a diabetes specialist via home-based
      telemedicine on high-cost health care utilization - specifically emergency department (ED)
      visits and diabetes-related hospitalizations.
    


Intervention name(s): Telemedicine Intervention
Intervention type(s): Behavioral
Intervention description(s): Home-based telemedicine visits
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Pediatrics
Efficacy of Polyglucosamine Long Term Treatment
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The polyglucosamine, specification L112, is a medical device and in this clinical trial used
      for weight reduction in moderately obese participants following a long term treatment lasting
      12 months. The rationale for this study is to show that overweight can be reduced by taking 2
      times daily 2 tablets with the main meals.
    

Detailed description: 
      Two groups of subjects were compared. A comparable diet condition, consisting of 10 %
      reduction of caloric intake was followed, according to a questionnaire based on the weekly
      number of servings. No modification of physical activity was requested.

      One group had to take the polyglucosamine tablets and the other group placebo tablets for at
      least 12 months. It is known, that polyglucosamine is a fat binder acting in a
      physical-chemical manner, the positive charged fiber is bound to the negative charged dietary
      fat and this complex is unable to pass the gut wall into the body but is naturally
      excreted,hence this energy is not available. Therefore, this medical device should show a
      measurable reduction in body weight.
    

Intervention name(s): polygucosamine; placebo
Intervention type(s): Device; Other
Intervention description(s): 2 times daily 2 polyglucosamine tablets with the two main meals with 10 % reduction of caloric intake with no increase of physical activity.; 2 times daily 2 placebo tablets with the two main meals with 10 % reduction of caloric intake with no increase of physical activity.
Other intervention name(s): ß-1,4 polymer of D-glucosamine and N-acetyl-D-glucosamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: obesity; body weight; overweight; weight loss; polyglucosamine; L112; caloric restriction; physical activity
Safety and Tolerability Study of ABT-089 in Children With Attention-Deficit/Hyperactivity Disorder (ADHD)
Condition: Attention-Deficit/Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to test if the investigational medication ABT-089 is a safe and
      effective treatment for children with Attention Deficit Hyperactivity Disorder (ADHD).
    


Intervention name(s): ABT-089; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will take 10 mg capsules and/or 40 mg tablets (actual dose based on weight) once daily for 6 weeks.; Subjects will take placebo capsules and/or tablets (number of capsules or tablets will be based upon weight) once daily for duration of the study.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment