bioihbjkbjnl/mcl2 huggingface dataset:
PSG and Neuroendocrine Hormones in Subjective Cognitive Impaired Patients With Transformed Migraine
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Observational

Summary: 
      Transformed migraine is the most common and challenging subtype of chronic daily headache
      disorders35. Patients with transformed migraine often report an evolutionary process that
      occurs over months or years in which headaches increase in frequency, change characteristics
      and ultimately result in patterns of daily or near-daily headaches resembling a mixture of
      tension-type headache and migraine.
    

Detailed description: 
      The present study aimed to investigate the presence and frequency of cognitive affection in
      patients with transformed migraines, as well as to analyze the association of cognitive
      affection with clinical features and headache impact, anxiety, depression, and quality of
      sleep.
    

Intervention name(s): Polysomnography
Intervention type(s): Device
Intervention description(s): PSG was carried out for 41 patients with subjective cognitive impairment and 41 age and sex-matched controls. PSG with standard EEG montage that includes bilateral EOG and four EEG leads were used. A single attended overnight PSG study was performed at the Clinical Neurophysiology Unit of Mansoura University Hospitals. Patients were studied in a quiet, darkened room with no medications were used to induce sleep. All participants underwent one night of laboratory-based PSG.
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        The diagnosis of headache disorders was based on the International Classification of
        Disease, Eleventh Revision (ICD-11). Patients included were adults with clinically
        confirmed of chronic migraine, completion of cognitive testing and questionnaires, and
        normal performance on cognitive tests based on normative data, stratified by gender, age,
        and education level.
      
Keywords: MIGRAINE
Zambia Integrated Management of Malaria and Pneumonia Study
Condition: Pneumonia; Malaria
MeSH terms: Pneumonia; Malaria
Study type: Interventional

Summary: 
      The purpose of the study is to demonstrate the effectiveness and feasibility of
      community-based management of pneumonia and malaria by community health workers (CHWs) in a
      rural district of Zambia.
    

Detailed description: 
      Pneumonia and malaria are the two leading causes of morbidity and mortality among children
      under five in sub-Saharan Africa. Due to limited access to health services in many developing
      countries, a number of global health organizations, including the World Health Organization,
      have strongly advocated the use of community health workers (CHWs) to deliver basic health
      care in the community and to facilitate referral to primary health facilities.

      Existing supported CHWs in the study area will be trained in the assessment and
      classification of children between six months and five years of age presenting with fever
      and/or cough/difficult breathing. In the intervention arm, CHWs will be supplied with rapid
      diagnostic tests (RDTs), Coartem (a fixed dose combination of artemether-lumefantrine) and
      amoxicillin. The intervention CHWs will be trained to use RDTs in patients with reported
      fever and provide those with a positive result with Coartem; and patients suspected of
      pneumonia (based on fast breathing) will be treated with amoxicillin as per the standard of
      care at health facilities and monitored. In the control arm, no RDT will be performed. The
      CHWs will be supplied with Coartem to treat malaria/febrile illness as per the integrated
      management of childhood illnesses (IMCI) guidelines and patients suspected of pneumonia will
      be referred to the health facility for treatment as per the current practice. Data collectors
      will routinely visit CHWs to collect data on their consultations and follow-up patients
      treated by CHWs in their homes..
    

Intervention name(s): Coartem and amoxicillin; Coartem
Intervention type(s): Drug; Drug
Intervention description(s): Perform RDT and give Coartem for malaria and give amoxicillin for fast breathing; Give Coartem without RDT and refer fast breathing
Intervention MeSH terms: Amoxicillin; Artemether, Lumefantrine Drug Combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: community health care; community health worker; malaria; pneumonia; rapid diagnostic test
Does a Low-Fat Vegetarian Diet Improve Insulin Resistance in Individuals With Type 2 Diabetes?
Condition: Insulin Resistance
MeSH terms: Insulin Resistance
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of the study is to evaluate the effect of experimental (vegetarian) diet compared to
      conventional diet with similar caloric restriction on insulin resistance, body weight and
      body composition in type 2 diabetic patients after 3 month diet program and additional 3
      month diet program combined with intensive exercise.

      Hypothesis: Greater improvement in insulin resistance, greater weight loss without
      compromising the body composition (subjects will lose fat preferentially to lean body mass)
      and differences in the fatty tissue metabolism will be found in the experimental (vegetarian)
      group compared to the control (conventional diet) group despite the similar advise on caloric
      restriction in both diets. The differences between the two groups will increase after an
      intensive physical exercise program.
    

Detailed description: 
      Open randomized study. Individuals with type 2 diabetes (n=60) will be recruited through
      newspaper advertisements and through advertisements in the hospital. They will be randomly
      assigned to a low-fat vegetarian diet or a diet following the guidelines of the Study Group
      on Diabetes and Nutrition of the European Association for the Study of Diabetes (DNSG) (21)
      with similar caloric restriction (-500 kcal/d). The participants will be followed for 12
      weeks and then for another 12 weeks with the addition of intensive physical exercise. All
      meals during the 6 months will be provided.
    

Intervention name(s): diabetic diet following the DNSG guidelines; low-fat vegetarian diet
Intervention type(s): Other; Other
Intervention description(s): The DNSG diet consists of 15-20% protein, ≤7% saturated fat, 60-70% carbohydrate and monounsaturated fats, cholesterol ≤200 mg/day, fiber content 20-30g/day.; The low-fat vegetarian diet (~10% of energy from fat, 15% protein, and 75% carbohydrate, fiber content 40-50 g/day) consists of vegetables, fruits, grains, legumes and small amounts of nuts. Participants will be asked to avoid animal products and added fats and to favor low-glycemic index foods, such as beans and green vegetables.
Allocation: Randomized
Intervention model: Parallel Assignment
Primary purpose: Treatment
Keywords: insulin resistance; vegetarian diet
A Randomized, Double-Blinded, Placebo-Controlled, Two-Way Crossover Study to Investigate the Safety and Toleration of Single Dose Sildenafil in Subjects Receiving Chronic UK-369,0031
Condition: Prostatic Hyperplasia; Urinary Bladder, Overactive; Erectile Dysfunction
MeSH terms: Erectile Dysfunction; Prostatic Hyperplasia; Urinary Bladder, Overactive; Hyperplasia
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate the safety and overall tolerability of co-administration two PDE5 inhibitors
      UK369,003 and sildenafil
    


Intervention name(s): UK369,003; sildenafil; sildenafil matching placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): oral tablet, once a day; single oral dose on day 14 or day 17; single oral dose on day 14 or day 17
Other intervention name(s): viagra
Intervention MeSH terms: Sildenafil Citrate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Efficacy and Safety of One Single Dose of SR58611 Compared to Placebo and Paroxetine
Condition: Major Depressive Disorders
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      Primary objective is to demonstrate the antidepressant efficacy on the Hamilton depression
      rating scale (HAM-D) of amibegron (SR58611) 700 mg/day compared to placebo in the treatment
      of patients with a recurrent major depressive episode (MDD).

      Secondary objective is to assess the safety profile of amibegron 700 mg/d in comparison to
      placebo and to assess plasma concentrations of the active metabolite.
    


Intervention name(s): amibegron (SR58611A); placebo; paroxetine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): oral administration of 2x 700 mg/day in 12h intervals; oral administration in 12h intervals; oral administration of 20 mg/day
Intervention MeSH terms: Paroxetine; Amibegron; Amibegron hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Depression
Study of DCR-AUD in Healthy Volunteers
Condition: Alcohol Use Disorder (AUD)
MeSH terms: Alcoholism
Study type: Interventional
Phase: Phase 1

Summary: 
      DCR-AUD will be evaluated for safety, tolerability, pharmacokinetics, and pharmacodynamics in
      healthy volunteers.
    

Detailed description: 
      DCR-AUD is being developed for the treatment of alcohol use disorder (AUD) in adults using an
      RNA interference (RNAi) technology platform. This is a 24-week, randomized, double-blind,
      placebo-controlled study to evaluate the safety, tolerability, PK, and PD of single-ascending
      doses (SAD) of DCR-AUD administered to adult HVs. The single doses of DCR-AUD will be
      administered to adult HVs across 4 sequential cohorts (3 planned [80 mg, 240 mg, 480 mg] and
      one optional [960 mg]). Each cohort will comprise a sentinel group of 3 participants (2
      active, 1 placebo) and an expanded group of 6 participants (4 active, 2 placebo). The
      sentinel group will be followed for the assessment of safety and tolerability and
      characterization of PK but who will not undergo any EIAs. Participants will receive a single
      dose of study intervention on Day 1 and will be followed for 24 weeks. Participants who have
      positive ethanol reaction symptoms at the Day 169 EIA (e.g., nausea, vomiting, or substantial
      flushing) will return every 28 (±7) days for follow-up EIAs until the positive ethanol
      reaction symptoms abate. These conditional follow-up (CFU) EIAs will not require overnight
      admission to the clinic, but all other aspects of the EIA will be conducted (see Table 3).
      Participants will be observed for not less than 6 hours after ethanol administration and will
      not be discharged until the Investigator deems it medically safe to do so.
    

Intervention name(s): DCR-AUD; Placebo for DCR-AUD
Intervention type(s): Drug; Drug
Intervention description(s): DCR-A1203, the drug substance of DCR-AUD, is a synthetic double-stranded (hybridized duplex) RNA oligonucleotide conjugated to GalNAc ligands that enable specific hepatic access and uptake after subcutaneous administration. DCR-AUD is a sterile solution of DCR-A1203 at a concentration of 160 mg/mL in water for injection (WFI).; 0.9% saline for injection
Other intervention name(s): DCR-A1203; Placebo
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
24-hour Study of Dorzolamide/Timolol and Latanoprost/Timolol Fixed Combinations
Condition: Open-angle Glaucoma
MeSH terms: Glaucoma; Glaucoma, Open-Angle
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective of this crossover trial is to compare the 3-month mean 24-hour
      intraocular pressure (IOP) control and safety of dorzolamide/timolol fixed combination (DTFC)
      given twice daily, versus latanoprost/timolol fixed combination (LTFC) given in the evening
      and placebo given in the morning, versus adjunctive therapy with DTFC given twice daily and
      latanoprost 0.005% given once in the evening in open-angle glaucoma patients who are
      insufficiently controlled with latanoprost monotherapy.
    


Intervention name(s): Drug: dorzolamide/timolol; Drug: latanoprost/timolol; dorzolamide/timolol and latanoprost; placebo (artificial tears)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Timolol; Dorzolamide; Latanoprost; Lubricant Eye Drops
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Study of Safety, Tolerability and Efficacy of MK0493 in Obese Patients (0493-008)(COMPLETED)
Condition: Obesity
Study type: Interventional
Phase: Phase 2

Summary: 
      To assess the effect of MK0493 on body weight, blood pressure, mood, and appetite.
    


Intervention name(s): MK0493
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
The Clinical Effect of i-FACTOR® Versus Allograft in Non-instrumentated Posterolateral Fusionin The IVANOS-study
Condition: Spinal Stenosis; Low Back Pain
MeSH terms: Spinal Stenosis; Low Back Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      The average life expectancy in Denmark is increasing resulting in an increasing part of the
      population having age-related disease, ex lumbar spinal stenosis (LSS). LSS causes
      constriction of the nerves in the lumbar spine resulting in pain in the legs and lower back,
      especially when standing and walking, known as neurogenic claudicatio(Goh KJ FAU - Khalifa et
      al.). LSS occurs in a combination of degenerative changes in the lower back, including
      hypertrophy of the ligamentum flavum, arthrosis of the facet joints and bulging of the disc.

      Current treatment of LSS is varied ranging from non-operativ conservative treatment to
      operation.

      Operative intervention shows very good results according to physical ability and
      pain(Christensen FB et al.;Hee HT and Wong;McGregor AH FAU - Hughes and Hughes;Xu et al.),
      but the most optimal treatment is still debated. Nevertheless, a decompression and, if
      needed, a spinal fusion is recommented.(Ausman).

      The investigators want to se whether i-FACTOR improves clinical outcomes compared to using
      allograft in spinal fusion in the elderly, and thereby find an improved methods operating
      this diffycult patient population.

      The hypothesis is, that there is no difference in clinical outcomes whether you use i-FACTOR
      or allograft i non-instrumentated spinal fusion surgery in patients with spinal stenosis due
      to degenerative listhesis.
    

Detailed description: 
      Se above
    

Intervention name(s): i-FACTOR; Allograft
Intervention type(s): Procedure; Procedure
Intervention description(s): Between 5-10 CC i-FACTOR putty mixed with local harvested autograft pr level spondylodesis compared to 30 grams of allograft pr level mixed with local harvested aulograft.; Approx 50 g of allograft bone in the fused site
Other intervention name(s): P15
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ODI
Cold Water Immersion Stirring in Hyperthermic Individuals
Condition: Hyperthermia
MeSH terms: Hyperthermia
Study type: Interventional

Summary: 
      The best way to cool a very hot person is using cold water immersion, however, the
      optimization of this technique has not been established. The goal of this study is to
      determine differences in cooling rates among two types of cold water immersion and passive
      cooling following immersion.
    


Intervention name(s): Water Stirring; No Water Stirring
Intervention type(s): Other; Other
Intervention description(s): Following an active heating protocol, the cooling intervention includes vigorous water stirring throughout cold water immersion.; Following an active heating protocol, the cooling intervention includes no water stirring throughout cold water immersion.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized, counterbalanced, crossover design
Masking: None (Open Label)
Primary purpose: Treatment
Asthma and Obstructive Sleep Apnea (OSA)
Condition: Asthma; Obstructive Sleep Apnea
MeSH terms: Asthma; Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      Obstructive sleep apnea (OSA) is a common but under-diagnosed form of sleep disordered
      breathing (SDB). Asthma is a common disease with rising prevalence, which continues to pose
      significant morbidity and costs. In spite of considerable progress in our understanding of
      asthma, a large number of individuals with asthma continue to have symptoms and subsequently,
      have a poor functional status, poor quality of life and increased health care costs. In many
      cases no apparent cause is found and optimal therapy does not achieve its goal. While recent
      data suggests that OSA is common in severe asthma, the prevalence of OSA and its predisposing
      factors have not been studied.
    


Intervention name(s): FDA-Approved Treatment
Intervention type(s): Other
Intervention description(s): 8 weeks of treatment with Continuous Positive Airway Pressure (CPAP)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: asthma; obstructive sleep apnea; severe asthma; OSA
Sorafenib Combined With Chemotherapy for Renal Collecting Duct Carcinoma
Condition: Renal Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Renal Cell; Carcinoma, Ductal
Study type: Interventional
Phase: Phase 2

Summary: 
      The goal of this clinical research study is to learn the effectiveness of sorafenib combined
      with gemcitabine plus cisplatin in the treatment of patients with locally advanced or
      metastatic collecting duct carcinoma(CDC) of the kidney. The safety of each treatment will
      also be studied.
    

Detailed description: 
      Collecting duct carcinoma(CDC) of the kidney is a rare and aggressive neoplasm of the distal
      collecting tubules for which there is no established treatment. Since the histology of
      collecting duct carcinoma is similar to that of urothelial carcinoma, a prospective phase II
      trial in France(2007) studied gemcitabine plus cisplatin as the first-line treatment of
      advanced CDC, resulting an effective rate of 26%. The targeted drugs can produce definite
      efficacy on renal clear cell carcinoma, but the data on targeted drugs for the treatment of
      renal advanced collecting duct carcinoma is limited. We sponsored this study based on the
      assumption that targeted drugs combined with chemotherapy can produce additive, positive
      effects in CDC.
    

Intervention name(s): Sorafenib; Gemcitabine; Cisplatin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Sorafenib 400mg BID by oral until progressed;; Gemcitabine: 1000mg/m2, administered by intravenous drip for 30~60min on Day 1 and 8,for 4 cycles;; Cisplatin: 25mg/m2, administered by intravenous drip on Day 1-3, with appropriate liquid hydration,for 4 cycles.
Other intervention name(s): Nexavar; Gemzar; Cis-Dichlorodiamineplatinum
Intervention MeSH terms: Gemcitabine; Sorafenib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: collected duct carcinoma; sorafenib
Infliximab Plus Methotrexate for the Treatment of Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety and effectiveness of infliximab (an
      anti-TNF chimeric monoclonal antibody [cA2]) in patients with active Rheumatoid Arthritis,
      despite methotrexate treatment.
    

Detailed description: 
      This is a placebo-controlled, double-blinded, randomized clinical study to evaluate the
      safety and effectiveness of infliximab in patients with active Rheumatoid Arthritis, despite
      methotrexate treatment. Infliximab is an anti-TNF chimeric monoclonal antibody (cA2). The
      primary measures of effectiveness include the change from baseline in American College of
      Rheumatology (ACR20) response at week 30, and the change in the modified van der Heijde Sharp
      Score. The ACR20 Responder Index a composite of clinical, laboratory, and functional measures
      and the van der Heijde-Sharp (vdH-S) scoring method is a method of rating structural damage
      in patients..

      Patients will be treated with either infliximab or matching placebo.
    

Intervention name(s): Placebo; Infliximab 3 mg/kg; Infliximab 10 mg/kg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Matching placebo will be adminstered at Week 0, 2, 6 and every 4 weeks up to Week 54.; Infliximab (anti-TNF chimeric monoclonal antibody [cA2]) 3 milligram per kilogram (mg/kg) will be administered as infusion at Week 0, 2, 6 and every 8 weeks or every 4 weeks up to Week 52.; Infliximab (anti-TNF chimeric monoclonal antibody [cA2]) 3 milligram per kilogram (mg/kg) will be administered as infusion at Week 0, 2, 6 and every 8 weeks or every 4 weeks up to Week 52.
Other intervention name(s): anti-TNF chimeric monoclonal antibody (cA2); anti-TNF chimeric monoclonal antibody (cA2)
Intervention MeSH terms: Infliximab; Antineoplastic Agents, Immunological; Antibodies; Immunoglobulins; Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Rheumatoid Arthritis; infliximab; methotrexate
ALK33BUP-201: Safety and Tolerability Study of ALKS 33-BUP (ALKS 5461) Administration in Subjects With MDD
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a multicenter, randomized, double-blind, placebo-controlled, parallel, multiple dose
      study designed to evaluate the safety and tolerability of the co-formulation of ALKS 33 with
      buprenorphine (ALKS 5461) in subjects with Major Depressive Disorder (MDD) who are
      inadequately/partially responding to current treatment with a stable dose of a
      serotonin-selective reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor
      (SNRI).
    


Intervention name(s): ALKS 5461; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Sublingual administration once daily for 7 consecutive days.; Sublingual administration once daily for 7 consecutive days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)