bioihbjkbjnl/mcl2 huggingface dataset:
Otolith Function in Patients With Primary Ciliary Dyskinesia
Condition: Primary Ciliary Dyskinesia
MeSH terms: Ciliary Motility Disorders; Dyskinesias
Study type: Observational

Summary: 
      The purpose of this study is to determine whether patients with primary ciliary dyskinesia
      (PCD) have reduced or absent otolith function.The otolith system is a specific part of the
      inner ear vestibular (balance) system that detects linear movement.
    

Detailed description: 
      Primary ciliary dyskinesia (PCD) is a genetically inherited condition. It is due to
      structural abnormalities of cilia, which are microscopic hairs found in organs and cells
      throughout the body. Patients with this condition typically develop upper respiratory tract
      symptoms such as sinusitis and glue ear, lower respiratory tract problems such as recurrent
      chest infections, and fertility problems. There is currently no evidence that patients with
      PCD have a higher incidence of balance problems. However, recent animal studies have shown
      that cilia may also be important in the development of part of the inner ear balance
      (vestibular) system, specifically the part that detects linear movement known as the otolith
      system.

      The investigators hope to determine whether patients with PCD have absent or reduced otolith
      function compared to the normal population. Balance problems are not currently screened for
      in PCD patients, and could be unrecognized and therefore untreated. It is also possible that
      PCD patients have compensated for absent otolith function and so are unaffected under normal
      circumstances; any additional insult to their balance system would cause more pronounced
      difficulties than expected and treatment might need to reflect this.
    

Intervention name(s): Vestibular evoked myogenic potentials (VEMPs); Utricular centrifugation test
Intervention type(s): Other; Other
Intervention description(s): Standard test of balance function; Standard test of balance function
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Ten patients from the PCD clinic at the Royal Brompton Hospital, London.
      
Keywords: primary ciliary dyskinesia; otolith; vestibular tests
HIV-HCV Coinfection: Impact of Immune Dysfunction
Condition: HIV Infections; Hepatitis
MeSH terms: Coinfection; Immune System Diseases
Study type: Observational

Summary: 
      Effective therapy for human immunodeficiency virus (HIV) infection has markedly prolonged
      survival in infected individuals. As a result, other diseases are now becoming clinically
      significant. Approximately 30% of HIV infected patients are co-infected with hepatitis C
      virus (HCV) which is now the leading co-morbid disease in co-infected individuals. The
      histologic severity and natural history of HCV has been reported to be accelerated in those
      co-infected with HIV. It is hypothesized that 1) the severity and progression of HCV disease
      is related to the immune competence of the individual, 2) immune restoration associated with
      HIV therapy may further accelerate the progression of HCV disease which may explain the
      marked increase in HCV related morbidity and mortality observed in recent years, and 3) the
      virologic response to anti-HCV treatment is directly related to the degree of immunologic
      competence. The specific aims of the proposal are: 1) To obtain, through multi-disciplinary
      didactic teaching, the necessary skills of clinical research design, data collection, data
      analysis, and biostatistical methods and 2) To study the impact of HIV disease on HCV, the
      effect of the immune function and immune restoration during HIV therapy on the natural
      history of HCV, and the efficacy of HCV treatment in HIV co-infection.
    

Detailed description: 
      Approximately 30% of HIV infected patients are co-infected with hepatitis C virus (HCV) which
      is now the leading co-morbid disease in co-infected individuals. The histologic severity and
      natural history of HCV has been reported to be accelerated in those co-infected with HIV. It
      is hypothesized that 1) the severity and progression of HCV disease is related to the immune
      competence of the individual, 2) immune restoration associated with HIV therapy may further
      accelerate the progression of HCV disease which may explain the marked increase in HCV
      related morbidity and mortality observed in recent years, and 3) the virologic response to
      anti-HCV treatment is directly related to the degree of immunologic competence. The specific
      aims of the proposal are: 1) To obtain, through multi-disciplinary didactic teaching, the
      necessary skills of clinical research design, data collection, data analysis, and
      biostatistical methods and 2) To study the impact of HIV disease on HCV, the effect of the
      immune function and immune restoration during HIV therapy on the natural history of HCV, and
      the efficacy of HCV treatment in HIV co-infection.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        HIV-HCV Coinfection
      
Biospecimen description: 
      Sera
    
Keywords: HIV-HCV Coinfection; HIV; Histology
Mass-balance Study of [14C]-APD421 in Healthy Volunteers
Condition: Post-operative Nausea and Vomiting
MeSH terms: Vomiting; Postoperative Nausea and Vomiting
Study type: Interventional
Phase: Phase 1

Summary: 
      Open-label, non-randomised, single dose study in 6 healthy male subjects to assess the mass
      balance recovery, metabolite profile, metabolite identification and pharmacokinetics of
      14C-labelled APD421
    


Intervention name(s): 14C-APD421
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Single-dose Nicotine Pharmacokinetics With Four Oral Nicotine Replacement Products
Condition: Tobacco Dependence
MeSH terms: Tobacco Use Disorder
Study type: Interventional

Summary: 
      Single-dose nicotine pharmacokinetics with four oral nicotine replacement products. A study
      in healthy smokers.
    

Detailed description: 
      Forty-four (44) healthy male or female subjects will be included. Single doses of an
      experimental Nicotine medicated chewing gum 6 mg and Nicorette® Freshfruit gum 4 mg and 2 mg
      and NiQuitin™ Mint lozenge 4 mg will be administered in a standardized mode, on four separate
      treatment visits. Periods without nicotine replacement therapy, each lasting for at least 36
      hours, will separate the treatment visits. The subjects will abstain from smoking from 8 pm
      the evening before each treatment visit and until the end of each visit. Blood for
      pharmacokinetic analyses will be drawn before, and at 2, 4, 6, 8, 10, 15, 20, 30, 45, and 60
      minutes as well as at 1.5, 2, 4, 6, 8, 10, and 12 hours after, product administration.
      Subjects will be monitored to capture any adverse events that may occur.
    

Intervention name(s): Nicotine Medicated Gum; 4 mg Nicotine Gum; 2 mg Nicotine Gum; 4 mg Nicotine Lozenge
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Dosage Form: Gum; Dosage: 6 mg; Frequency: Once; Duration: 30 minutes; Dosage Form: Gum; Dosage: 4 mg; Frequency: Once; Duration: 30 minutes; Dosage Form: Gum; Dosage: 2 mg; Frequency: Once; Duration: 30 minutes; Dosage Form: Lozenge; Dosage: 4 mg; Frequency: Once; Duration: until dissolved
Other intervention name(s): Not marketed; Nicorette® Freshfruit gum; Nicorette® Freshfruit gum; NiQuitin™ Mint lozenge
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Smoking Cessation, Nicotine pharmacokinetics
A Comparison Between Two Techniques for Performing Decompressive Craniectomy
Condition: Brain Edema; Craniocerebral Trauma; Infarction, Middle Cerebral Artery
MeSH terms: Brain Edema; Craniocerebral Trauma; Infarction, Middle Cerebral Artery; Infarction
Study type: Interventional

Summary: 
      The purpose of this study is to compare two surgical techniques for a neurosurgical procedure
      used to treat cerebral edema (decompressive craniectomy): with watertight duraplasty vs.
      without watertight duraplasty (rapid closure decompressive craniectomy).
    

Detailed description: 
      After clinical indication for unilateral decompressive craniectomy (DC), patients were
      randomized by numbered envelopes into 2 groups: with watertight duraplasty (control group)
      vs. without watertight duraplasty / rapid closure DC (test group). In all cases, a large
      trauma flap (i.e. large reverse question mark starting from the tragus and extending to the
      midline) was performed. Skin, galea and muscle layers were elevated according to surgeon
      preference. Thus a wide (at least 12x15cm) craniotomy was performed and the temporal bone was
      removed until flush with the middle fossa floor. After dural opening, watertight duraplasty
      with pericranium or an artificial graft (at surgeon's discretion) was performed in the
      control group, while no watertight duraplasty was performed in the test group, and exposed
      brain parenchyma was covered with Surgicel®. Usual closure was then performed. Patients were
      then monitored daily by evaluators blinded to the randomization (control or test group) from
      the date of surgery until hospital discharge or death.
    

Intervention name(s): Without watertight duraplasty
Intervention type(s): Procedure
Intervention description(s): After standard craniectomy and dural opening, provided there is no brain contusions or hematomas requiring surgical evacuation, no watertight duraplasty is performed. The dura is left opened and the brain parenchyma is covered with Surgicel. Usual closure is then performed.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Decompressive craniectomy; Brain Edema
Testing the Effectiveness of Adolescent Depression Prevention Programs (The OregonBlues Study)
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study will test the effectiveness of two programs for preventing depression in
      adolescents.
    

Detailed description: 
      Major depression is one of the most common psychiatric disorders experienced by adolescents.
      Even adolescents with depressive symptoms below the level of diagnosis are at increased risk
      of a range of future problems, such as psychiatric disorders, impaired social functioning,
      and substance abuse.

      Depression prevention therapies have had mixed results. Those that are implemented
      universally have shown little efficacy, although those that specifically target adolescents
      at risk of depression have shown greater efficacy. A large scale effectiveness trial-one that
      applies treatments outside of a lab in "real world" settings-of a targeted depression
      prevention therapy has not been conducted. This study will test the effectiveness of two
      therapies for preventing depression in adolescents. The first is a brief, group
      cognitive-behavioral depression prevention program, and the second is bibliotherapy, which
      involves giving participants a self-help book for depression. Bibliotherapy has shown
      efficacy in previous research but has not been examined in an effectiveness trial.

      Participation in this study will last 24 months. Participants will be randomly assigned to
      one of three conditions: a six-session, cognitive-behavioral depression prevention group; a
      bibliotherapy group; and an assessment only group. Participants in the cognitive-behavioral
      group will meet with a study therapist and other group members to learn strategies for
      preventing depression. Participants in the bibliotherapy group will be given a self-help book
      titled "Feeling Good" with information on preventing depression. Participants in the
      assessment only group will receive a pamphlet on depression symptoms and treatment. All
      participants will complete assessments at baseline; after the cognitive-behavioral group has
      been completed; and at 6-, 12-, 18-, and 24-month follow-ups. These assessments will include
      an interview about depression symptoms and a survey about thoughts, feelings, actions,
      depression, and substance abuse.
    

Intervention name(s): Cognitive-behavioral group; Cognitive-behavioral bibliotherapy
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Six sessions of cognitive-behavioral depression prevention group intervention; Cognitive-behavioral bibliotherapy, delivered from the book "Feeling Good"
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Adolescents; Prevention; Bibliotherapy
Rasagiline in Cognitive-impairment Related Depression: AzileCt in COgnitive-impairment Related DepressiOn
Condition: Depressive Symptoms; Parkinson's Disease
MeSH terms: Parkinson Disease; Depression
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary endpoint for this study is the clinical response after 12 weeks of treatment,
      defined as a change in total score from baseline depressive symptoms as measured by the Beck
      Depression Inventory-Amended (BDI-IA) total score.
    

Detailed description: 
      ACCORDO is a multicentre, randomised, double-blind, and placebo-controlled study conducted in
      12 Italian centres. Subjects are screened by means of the BDI-IA (cut-off 15) and randomised
      to treatment with rasagiline or placebo for 12 weeks.

      Subjects have to be on stable treatment with dopaminergic agents at least 4 weeks before
      baseline, and maintained so during the course of the study.

      The primary objective is to evaluate whether rasagiline compared to placebo improves
      depressive symptoms as evaluated by the BDI-IA total score.
    

Intervention name(s): Rasagiline; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 1 mg/day for 12 weeks; orally; Once daily for 12 weeks; orally
Other intervention name(s): Azilect
Intervention MeSH terms: Rasagiline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Rasagiline; Depressive Symptoms; Cognition
Telbivudine Therapy in HBeAg-positive Pregnant Women to Prevent Mother-to-infant Transmission of HBV
Condition: HBV
Study type: Interventional
Phase: Phase 4

Summary: 
      Infants of hepatitis B virus (HBV)-infected mothers with positive hepatitis B e antigen
      (HBeAg) have an increased risk of becoming infected with HBV. This study will determine
      whether telbivudine among both hepatitis B surface antigen (HBsAg) and HBeAg positive
      pregnant women during the third trimester, in addition to standard immunoprophylaxis in
      infants, will be more effective than standard immunoprophylaxis alone at preventing HBV
      infections in these infants.
    

Detailed description: 
      Infants of HBV-infected mothers with positive HBeAg have an increased risk of becoming
      infected with HBV. Standard immunoprophylaxis against mother-to-infant transmission of HBV
      includes administration of hepatitis B immunoglobulin (HBIG) and hepatitis B vaccine;
      however, approximately 5-15% of the infants are not protected despite having received these
      preventive measures. It is reported that antiviral prophylaxis among HBV-infected pregnant
      women can reduce mother-to-infant transmission of HBV. However, more research is needed to
      obtain the definite conclusion. This study will determine whether telbivudine among HBsAg-
      and HBeAg-positive pregnant women during the third trimester, in addition to standard
      immunoprophylaxis in infants, will be more effective than standard immunoprophylaxis alone at
      preventing HBV infections in these infants.
    

Intervention name(s): Telbivudine
Intervention type(s): Drug
Intervention description(s): HBsAg- and HBeAg-positive pregnant women at 28-32 weeks of gestation are given with telbivudine (oral 600 mg/day) until 4 weeks after delivery. Newborn infants are administered 100-200 IU HBIG within 12 hours after birth and vaccinated against hepatitis B with yeast recombinant hepatitis B vaccine (10 µg) at 0, 1, and 6-month schedule. HBV DNA and ALT levels are measured before the use of telbivudine, at delivery, and 1-2 months after stopping the drug. HBV serological markers, including HBsAg, anti-HBs, and anti-HBc, HBeAg and anti-HBe are tested in infants at age of 7-12 months.
Other intervention name(s): Anti-HBV therapy during pregnancy
Intervention MeSH terms: Telbivudine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Pregnant women; HBsAg positive; HBeAg positive; Telbivudine
Deflox Tablets Bioequivalence (BE) Trial
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study was to demonstrate the bioequivalence of Deflox® 50 milligrams (mg)
      tablets compared with Cataflam® DD tablets 50 mg administered as single dose in fasting
      conditions to healthy participants.
    


Intervention name(s): Deflox®; Cataflam DD®
Intervention type(s): Drug; Drug
Intervention description(s): Participants received a single oral dose of 50 mg Deflox® tablet in either treatment period 1 or 2 under fasting conditions.; Participants received a single oral dose of 50 mg Cataflam DD® tablet in either treatment period 1 or 2 under fasting conditions.
Other intervention name(s): Diclofenac Potassium
Intervention MeSH terms: Diclofenac
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Deflox®; Cataflam® DD; Diclofenac potassium; Healthy
Study Comparing Simulect Plus Standard Immunosuppression to Standard Immunosuppression Alone for the Prevention of Acute Rejection and Bronchiolitis Obliterans in Lung Transplant
Condition: COPD; Emphysema; Alpha-1 Antitrypsan Deficiency
MeSH terms: Bronchiolitis; Bronchiolitis Obliterans; Bronchiolitis Obliterans Syndrome; Emphysema
Study type: Interventional
Phase: Phase 3

Summary: 
      The study will evaluate the efficacy and safety of basiliximab Vs placebo as induction
      therapy combined with standard triple immunosuppression therapy, in the prevention of acute
      rejection episodes and prevention of Bronchiolitis Obliterans Syndrome.
    

Detailed description: 
      The objective of this study is to evaluate the efficacy and safety of basiluximab for the
      prevention of acute allograft lung rejection when used in addition to Neoral, corticosteroids
      and azathioprine. Acute rejection episodes will be evaluated during the first 6 months
      post-transplant. Bronchiolitis obliterans syndrome (BOS) will be evaluated at the end of 1
      year after transplant and at additional follow-up visits at 2 and 3 years after transplant.
    

Intervention name(s): placebo; basiliximab
Intervention type(s): Other; Drug
Intervention MeSH terms: Basiliximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Lung; Transplant; Rejection; BOS
The Effects of Aspirin in Gestation and Reproduction
Condition: Birth; Spontaneous Abortion
MeSH terms: Abortion, Spontaneous
Study type: Interventional

Summary: 
      The primary objective of the study is to help elucidate the effects of low-dose aspirin in
      combination with folic acid on the incidence of live births and spontaneous abortions among a
      group of women who become pregnant compared to a control group.
    

Detailed description: 
      Despite the fundamental nature of reproduction, for many it is a process fraught with
      frustration, inefficiency and imperfections, the effects of which can be severe. Infertility
      affects 10-15% of couples attempting to conceive. Among all women who conceive, the incidence
      of spontaneous abortion (SA) has been estimated to be between 15 and 31%, and in many cases
      the cause is unknown. Additionally, of the four million births yearly in the United States,
      between 8 and 15% will be born prematurely and experience increased morbidity and mortality
      as a result. An intervention with even a small absolute effect on any of these outcomes has
      great implications at the population level due to the large potential attributable benefit.

      One such potential intervention is low-dose acetylsalicylic-acid (aspirin). Aspirin has been
      a primary target of interest because of its anti-inflammatory, vasodilatory and platelet
      aggregation inhibition properties. To evaluate the effects of low-dose aspirin in combination
      with folic acid on the incidence of live births and spontaneous abortion, we are conducting a
      multi-site randomized controlled trial study with two sites and one data coordinating center.
      Women aged 18-40 currently trying to become pregnant and who have had a single spontaneous
      abortion in the past year will be eligible for the study. The recruitment goal is 1600 women.
      Participating women will be randomly assigned to one of two treatment groups. Those
      randomized to treatment will receive daily low-dose aspirin. Those randomized to placebo will
      receive daily placebo. Both groups will receive folic acid daily in accordance with
      recommendations from the U.S. Public Health Service for prevention of birth defects. The
      duration of treatment regimens (LDA and folic acid or placebo and folic acid) will be 6
      menstrual cycles, with those who become pregnant continuing until the end of pregnancy.
      Monthly urine and blood samples will be collected and questionnaires administered.
    

Intervention name(s): acetylsalicylic-acid (aspirin); Folic acid
Intervention type(s): Drug; Dietary Supplement
Intervention description(s): 81mg of low-dose aspirin plus 400micrograms of folic acid.; 400micrograms of folic acid.
Other intervention name(s): aspirin
Intervention MeSH terms: Aspirin; Folic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment