bioihbjkbjnl/mcl2 huggingface dataset:
A Study of Granulocyte Colony-Stimulating Factor Plus Recombinant Erythropoietin Plus Zidovudine in Patients With AIDS or AIDS-Related Complex
Condition: HIV Infections; Cytopenias
MeSH terms: AIDS-Related Complex
Study type: Interventional

Summary: 
      To evaluate the safety, tolerance and biological activity of filgrastim (granulocyte
      colony-stimulating factor; G-CSF) given by daily subcutaneous (SC) injection prior to and
      concomitantly with erythropoietin (EPO) and zidovudine (AZT) in patients with AIDS or severe
      AIDS related complex (ARC). To evaluate the safety, tolerance, and biological activity of EPO
      given 3 times weekly by SC injection concomitantly with G-CSF and prior to and concomitantly
      with AZT in patients with AIDS or severe ARC. To study the safety and tolerance of 3 dose
      levels of AZT given to patients with AIDS or severe ARC concomitantly treated with G-CSF and
      EPO. To study the effect of G-CSF alone and in combination with EPO on HIV replication in
      vivo as measured by circulating HIV p24 antigen, plasma HIV viremia and semiquantitative HIV
      cocultures.
    


Intervention name(s): Filgrastim; Epoetin alfa; Zidovudine
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Zidovudine; Epoetin Alfa
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Injections, Subcutaneous; Erythropoietin; Acquired Immunodeficiency Syndrome; AIDS-Related Complex; Zidovudine
Macronutrient Relations and Weight Loss in Obese Subjects
Condition: Obesity
MeSH terms: Weight Loss
Study type: Interventional

Summary: 
      The burden of overweight and obesity has dramatically increased during the last decades. High
      carbohydrate intake, particularly refined carbohydrates, probably increase the risk of
      obesity, type 2 diabetes, and metabolic syndrome. There is evidence that energy-restricted
      low-carbohydrate diets show greater weight loss and better improvement of cardiovascular risk
      markers compared to energy-restricted low-fat diets. Beside macronutrient relations, efficacy
      of weight loss programs depends on care and control. The investigators aim to investigate
      whether or not a carbohydrate-restricted telemedically guided weight loss program results in
      a more pronounced weight loss and influences metabolic risk markers more beneficial than a
      fat-restricted diet.
    

Detailed description: 
      see brief summary.
    

Intervention name(s): energy-restricted, CHO-restricted diet; energy-restricted, CHO-rich diet
Intervention type(s): Other; Other
Intervention description(s): carbohydrate content of the diet < 40% Frequency: daily Duration: 12 months; carbohydrate content of diet > 55% Frequency: daily Duration: 12 months
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: weight reduction; low-carbohydrate; body fat; telemedicine; cardiovascular risk markers
Vascular Endothelium Changes After Bariatric Surgery (Endothelial Progenitor Cells)
Condition: Type 2 Diabetes
Study type: Interventional

Summary: 
      Improvement in cardiovascular mortality is related to changes in pathologic autoantibodies
      and in the number of circulating functional replicative competent endothelial progenitor
      cells (EPC's) after bariatric surgery.
    

Detailed description: 
      Same as above
    

Intervention name(s): pre-bariatric weight loss program; bariatric surgery
Intervention type(s): Behavioral; Procedure
Intervention description(s): standard 6 month physician directed pre-bariatric weight loss program; bariatric surgery for weight loss
Other intervention name(s): weight loss program
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Safety and Effectiveness of Different ShangRing Device Sizes for Adult Male Circumcision in Lusaka, Zambia
Condition: Male Circumcision
Study type: Interventional

Summary: 
      The purpose of this study was to assess the safety, effectiveness and acceptability of
      providing a reduced number of ShangRing sizes for adult voluntary medical male circumcision
      (VMMC) within routine service delivery in Lusaka, Zambia.
    

Detailed description: 
      We conducted a randomized controlled trial and enrolled 500 HIV-negative men aged 18-49 years
      at 3 clinics. Participants were randomized to 1 of 2 study arms (Standard Sizing arm vs
      Modified Sizing arm) in a 1:1 ratio. All 14 adult ShangRing sizes (40-26 mm inner diameter,
      each varying by 1 mm) were available in the Standard Sizing arm; the Modified Sizing arm used
      every other size (40, 38, 36, 34, 32, 30, 28 mm inner diameter). Each participant was
      scheduled for 2 follow-up visits: the removal visit (day 7 after placement) and the healing
      check visit (day 42 after placement), when they were evaluated for adverse events (AEs),
      pain, and healing.
    

Intervention name(s): ShangRing
Intervention type(s): Device
Intervention description(s): ShangRing device for male circumcision
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: HIV prevention; ShangRing; adverse events; wound healing; voluntary medical male circumcision (VMMC); medical device; Zambia
Effect of Sporebiotics in FD
Condition: Dyspepsia; Dysbiosis
MeSH terms: Dyspepsia; Dysbiosis
Study type: Interventional

Summary: 
      Single-site prospective interventional study aiming to demonstrate the effect of
      spore-forming probiotics on dyspeptic symptoms and blood, saliva and stool parameters in FD
      patients with and without acid suppression, compared to placebo.
    

Detailed description: 
      Prospective randomized placebo-controlled study in 2 parallel FD cohorts (8 weeks) with
      open-label extension phase (8 weeks):

        -  cohort 1FD (on-PPI): study procedures at inclusion (1) and after 8 weeks on-PPI+
           sporebiotics or placebo (2) followed by 8 weeks on-PPI+ sporebiotics (open label)

        -  cohort 2FD (off-PPI): study procedures at inclusion (1) and after 8 weeks of
           sporebiotics or placebo (2) followed by 8 weeks of sporebiotics (open label)

      Clinical outcomes and blood, saliva and stool parameters will be assessed at the beginning
      and end of each treatment period (week 0, 8 and 16) with additional questionnaires after 1
      month (week 4 and 12).
    

Intervention name(s): spore-forming probiotic; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): spore-forming probiotic administered as 1 capsule twice daily (2,5 x 109 CFU per capsule) during 8 weeks; similar capsules administered twice daily
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized placebo-controlled study in 2 parallel FD cohorts
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: spore-forming probiotic; sporebiotic; proton pump inhibitor; dyspepsia
Caustic Esophageal Burns in Children and High Doses of Methylprednisolone
Condition: Esophageal Diseases
MeSH terms: Esophageal Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      Corrosive substance ingestion in childhood is a public health issue in developing countries
      and several management protocols were proposed to prevent esophageal strictures. The role of
      corticosteroids in preventing corrosive-induced strictures is controversial. The
      investigators' aim is to study the influence of high doses of corticosteroids to prevent
      esophageal strictures.
    


Intervention name(s): methylprednisolon
Intervention type(s): Drug
Intervention MeSH terms: Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Care Provider)
Primary purpose: Prevention
Keywords: caustic; corticosteroid therapy; stricture; children
A Study of PEP02 in Combination With 5-fluorouracil (5-FU) and Leucovorin (LV) in Advanced Solid Tumors
Condition: Solid Tumor
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is a multi-center, open-label, phase I, dose escalation study of PEP02 (liposomal
      encapsulated irinotecan) in combination with 5-FU and LV in patients with advanced solid
      tumors.
    

Detailed description: 
      In this study, the initial starting dose of PEP02 is 60 mg/m2, and was escalated by
      increments of 20 mg/m2 between dose levels. 5-FU and LV was given as 24-hour infusion via an
      implanted central venous catheter, with dose fixed at 2000 mg/m2 and 200 mg/m2, respectively.
      PEP02 was administered on Day 1; 5-FU/LV was started after the end of PEP02 infusion on Day 1
      and also on Day 8. Treatment repeated every 3 weeks and it was regarded as one cycle of
      treatment.
    

Intervention name(s): PEP02; 5-FU; LV
Intervention type(s): Drug; Drug; Drug
Intervention description(s): PEP02 was administered on Day 1. Treatment repeated every 3 weeks and it was regarded as one cycle of treatment.; 5-FU/LV were started after the end of PEP02 infusion on Day 1 and also on Day 8. Treatment repeated every 3 weeks and it was regarded as one cycle of treatment.; 5-FU/LV were started after the end of PEP02 infusion on Day 1 and also on Day 8. Treatment repeated every 3 weeks and it was regarded as one cycle of treatment.
Other intervention name(s): liposomal irinotecan; Fluorouracil; Leucovorin
Intervention MeSH terms: Leucovorin; Fluorouracil; Irinotecan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Feasibility of IPL for Reducing Dry Eye Symptoms Caused by MGD
Condition: Dry Eye Syndromes
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Meibomian Gland Dysfunction
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate if, in patients with meibomian gland dysfunction
      (MGD), treatment with the Lumenis M22 Intense Pulsed Light (IPL) system causes a reduction in
      dry eye symptoms post-treatment, compared to pre-treatment.
    

Detailed description: 
      The IPL module has FDA clearance (K142860) for a wide range of indications, including benign
      cavernous hemangiomas, benign venous malformations, telangiectasia, port-wine stains,
      pigmented lesions and erythema of rosacea. As shown by a retrospective study, in over 85% of
      the cases, using IPL in subjects with ocular rosacea also alleviated the symptoms of DED
      caused by MGD. No serious adverse events were recorded, suggesting that IPL therapy
      administered close to the ocular orbits is safe (provided that the eyes are shielded).
      However, the above mentioned study was retrospective. Therefore, additional evidence is
      needed in order to substantiate the hypothesis that alleviation of MGD symptom was
      facilitated by IPL treatments.

      The aim of the current study is to assess the safety and efficacy of IPL treatment for
      reducing the symptoms of dry eye disease (DED) in subjects with MGD. The study hypothesis is
      that in a study population of subjects diagnosed with moderate to severe MGD, 4 sessions of
      IPL therapy with the M22 system, followed by expression of the MGs, will cause a significant
      increase in tear break-up time post-treatment, compared to pre-treatment.
    

Intervention name(s): M22-IPL
Intervention type(s): Device
Intervention description(s): The IPL hand piece operates at a spectrum of 400-1200nm with 7 different filters that can be easily inserted to the hand piece to treat different conditions. The IPL hand piece also includes 2 different sapphire cooled light guides of 8x15mm and 15x35mm. The cut-off filters that will be used for this evaluation are filters blocking wavelengths of 560 and 595 nm.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Meibomian Gland Dysfunction; Dry eye symptoms; Intense Pulsed Light
Effective Study of Live Attenuated Varicella Vaccine to Treat Severe Resistant Psoriasis
Condition: Psoriasis
MeSH terms: Chickenpox; Psoriasis
Study type: Interventional
Phase: Phase 4

Summary: 
      Immunotherapy was reported in the treatment of psoriasis. Treatment of resistant psoriasis
      may be difficult and cyclosporine can induce some remission.

      The investigators hypothesized that the combined use of live attenuated varicella vaccine as
      an adjuvant therapy to low dose cyclosporine in the treatment of severe resistant psoriasis
      can give positive responses.
    


Intervention name(s): live attenuated chicken pox vaccine; saline, efficacy
Intervention type(s): Drug; Drug
Intervention description(s): Each immunizing dose was given subcutaneously (SC) in the form of 0.5 ml reconstituted vaccine which contains not less than 1033 plaque forming units (PFU) of the attenuated varicella-zoster-virus (VZV), which meets the World Health Organization (WHO) requirements for biological substances and for varicella vaccines. Doses were given 3 weeks apart for a total duration of 12 weeks (3 months).; 4 doses of SC saline (0.5 ml) -as a placebo- in the same pattern as group A patients
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: severe resistant
Diabetes Peripheral Neuropathy and Small-fibre Nerve Damage: A Comparative Study
Condition: Diabetes Mellitus; Peripheral Neuropathy; Small Fibre Neuropathy; Autonomic Neuropathy
MeSH terms: Peripheral Nervous System Diseases; Small Fiber Neuropathy
Study type: Observational

Summary: 
      The purpose of this study is to investigate whether patients with diabetes-related peripheral
      neuropathic pain also have non-recognized damage to the intestine caused by autonomic
      neuropathy. The model will shed light on aspects of peripheral nerve injuries on both somatic
      and as well as visceral sensory nerves. Classical autonomic parameters from
      electrocardiography (ECG) and Holter (24-h ECG and blood pressure) are compared with
      peripheral nerve injuries. The damage of autonomic nerves often recognized late in the course
      when patients develop gastroparesis, however an earlier recognition of this nerve damage may
      help clarifying the fundamental pathomechanisms and thereby optimize treatment for this
      patient group in the future.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Patients with verified diabetic neuropathy.
Persistent Pain After Reconstruction Following Mastectomy
Condition: Breast Cancer; Chronic Pain
MeSH terms: Chronic Pain
Study type: Observational

Summary: 
      A cross sectional study to determine the prevalence of persistent pain after reconstructive
      surgery after mastectomy for breast cancer, with a comparative analysis of a cohort treated
      with mastectomy without reconstruction.
    

Detailed description: 
      The aim of the study is to determine if reconstruction of the breast after mastectomy
      increases the risk of reporting persistent pain 2-3 years after surgery.
    

Intervention name(s): Reconstruction
Intervention type(s): Procedure
Intervention description(s): Reconstructive surgery after mastectomy, either by expander or autologous tissue. Includes both primary and secondary reconstruction
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Nationwide cross-sectional cohort
      
Keywords: Pain; Neuropathic pain; Chronic pain
Fiberoptic Bronchoscope of Double Lumen Tube and Single Lumen Tube in Patients With Semi-regid Neck Collar.
Condition: Intubation;Difficult; Thoracic Diseases
MeSH terms: Thoracic Diseases
Study type: Interventional

Summary: 
      Many intrathoracic procedures demand optimal collapse of the operative lung to facilitate
      surgical exposure. Single-lung ventilation can be achieved using a double-lumen tube (DLT), a
      Univent tube, or an independent bronchial blocker. Insertion of a DLT using a direct
      laryngoscope can be more difficult than that of single-lumen tube (SLT), especially in
      patients for whom airway difficulty is anticipated. The safest of the proposed methods
      involves the placement of an SLT with the aid of an fibreoptic bronchoscope (FOB), following
      which the SLT is replaced with a DLT using an airway exchange technique in these patients.
      HumanBroncho® (Insung Medical, Seoul, Korea) is a new silicone DLT with a soft, flexible,
      non-bevelled, wire-reinforced tip. The oval shape, obtuse angle, and short lateral internal
      diameter of the bronchial lumen and its flexibility may allow for advancement to the trachea
      over the FOB with as much as ease as a standard SLT. In the present study, the investigators
      aimed to test the hypothesis that the HumanBroncho® DLT would be non-inferior to a standard
      SLT with regard to intubation time over an FOB in patients with semi-rigid neck collar
      simulating difficult airway.
    


Intervention name(s): single lumen tube and bronchial blocker; double lumen tube
Intervention type(s): Device; Device
Intervention description(s): neck collar apply. fibreoptic intubation with single lumen tube and bronchial blocker.; neck collar apply. fibreoptic intubation with double lumen tube.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Other
Keywords: fibreoptic intubation; double lumen tube; difficult intubation
HIV Counseling Intervention for Methadone-Maintained Patients - 2
Condition: Opioid-Related Disorders
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate HIV counseling intervention for Methadone-Maintained
      Patients.
    

Detailed description: 
      The purpose of this proposal is to evaluate, in methadone-maintained patients the association
      between an ADHD diagnosis and high-risk HIV/Hepatitis behavior. In addition, the
      investigators would like to determine whether a new manually-guided HIV intervention; RISE:
      Reduce high risk Intravenous drug use and unsafe Sexual Encounters is superior to standard
      HIV/Hepatitis psycho-education.
    

Intervention name(s): Behavior Therapy-RISE; Standard prevention Education
Intervention type(s): Behavioral; Behavioral
Intervention description(s): manually-guided HIV intervention RISE: Reduce high risk Intravenous drug use and unsafe Sexual Encounter; standard psychosocial Education for HIV/hepatitis prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: HIV; methadone maintenance
Study Investigating the Efficacy and Safety of a Contraceptive Patch for 13 Cycles
Condition: Contraception
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is examining a birth control patch for 13 cycles (1 year).
    


Intervention name(s): Gestodene/EE Patch (BAY86-5016)
Intervention type(s): Drug
Intervention description(s): 55 mg ethinyl estradiol & 2.1 mg gestodene, 21 days for 13 cycles
Intervention MeSH terms: Gestodene
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Pregnancy prevention; Female contraception; Patch
Time-dependent Improvement of Functional Outcome Following Oxford Medial Unicondylar Knee Replacement
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Observational

Summary: 
      The objective of this prospective study is to determine (1) the time course of
      patient-relevant functional outcome evaluated by the Knee injury and Osteoarthritis Outcome
      Score (KOOS) and (2) the time course of range of motion (ROM) the first six years following
      Oxford Medial Unicondylar Knee prosthesis. Improvement of patient self-reported pain and
      daily function during the study period, are of particular interest.
    

Detailed description: 
      The objective of this prospective study is to determine (1) the time course of
      patient-relevant functional outcome evaluated by the Knee injury and Osteoarthritis Outcome
      Score (KOOS) and (2) the time course of range of motion (ROM) the first six years following
      Oxford Medial Unicondylar Knee prosthesis. Improvement of patient self-reported pain and
      daily function during the study period, are of particular interest. Thats it!
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Consecutive patients operated with total knee arthroplasty at Martina Hansens Hospital,
        Akershus University Hospital and Baerum hospital
      
Keywords: Unicondylar Knee Replacement
Study to Evaluate the Effect of Omeprazole on the Pharmacokinetics of SPD422 (Anagrelide Hydrochloride) in Healthy Adult Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This Phase 1, open-label, single-sequence, non-randomized, multiple-dose, crossover
      pharmacokinetic study is a single site study in the United States and will be conducted to
      assess the effect of a CYP1A2 inducer (omeprazole 40 mg once daily [QD]) on the
      pharmacokinetics of anagrelide (1 mg) when administered concurrently in healthy participants.
    


Intervention name(s): SPD422; Omeprazole
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive 1 mg of SPD422 (2*0.5 mg) capsule orally on Day 1 and 8 in fasted state.; Participants will receive 40 mg of Omeprazole orally once daily on Days 2 - 8.
Other intervention name(s): Anagrelide hydrochloride
Intervention MeSH terms: Anagrelide; Omeprazole
Intervention model: Single Group Assignment
Intervention model description: Single sequence crossover drug-drug interaction study
Masking: None (Open Label)
Primary purpose: Treatment
The Study of Omalizumab (CMAB007 and Xolair) in Healthy Subjects to Compare the PK, PD and Safety
Condition: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      A phase 1, randomized, double-blind, parallel group, single-dose study to compare the
      pharmacokinetics, pharmacodynamics and safety of two formulations of Omalizumab (CMAB007 and
      Xolair) in healthy subjects.
    


Intervention name(s): Omalizumab
Intervention type(s): Drug
Intervention description(s): Biological: CMAB007 Biological: Xolair
Intervention MeSH terms: Omalizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Multi-Center Clinical Evaluation of Two Reusable Soft Contact Lenses
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional

Summary: 
      The purpose of this study is to compare the subjective performance of comfilcon A lens
      against samfilcon A lens after 4 weeks of reusable lens wear.
    

Detailed description: 
      This will be a 90 subject, randomized, bilateral, subject-masked, dispensing, cross-over
      study comparing comfilcon A versus samfilcon A lenses over 8 weeks of daily wear (2 x
      4-weeks). Both eyes will wear the same lens (test or control) for 4 weeks in a randomized
      fashion. Subjects will be masked to lens type and investigators will be masked to the lens
      codes.
    

Intervention name(s): comfilcon A; samfilcon A
Intervention type(s): Device; Device
Intervention description(s): contact lens; contact lens
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Other