bioihbjkbjnl/mcl2 huggingface dataset:
Intensive Versus Standard Follow up to Improve Continuous Positive Airway Pressure (CPAP) Compliance
Condition: Sleep Apnea
MeSH terms: Sleep Apnea Syndromes
Study type: Interventional

Summary: 
      The purpose of this study was to compare the effects on sleepiness, quality of life,
      depression, hospitalization and deaths rate, of intensive vs standard interventions, on CPAP
      adherence, 2 years after CPAP initiation.
    

Detailed description: 
      There is limited data concerning long-term randomized clinical trials proving the long-term
      efficacy of intensive use, follow programs on improving CPAP use. Therefore the investigators
      aimed to compare the effects on sleepiness, quality of life, depression, hospitalization and
      deaths rate, of intensive vs standard interventions, on CPAP adherence, 2 years after CPAP
      initiation.
    

Intervention name(s): Standard care; Intensive care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 24-h consultation telephone line to the sleep nurses to answer questions regarding CPAP usage. Patients were reviewed at 1 month and at 3 month intervals during the first year and every 6 months thereafter in the CPAP clinic by the nurse. Additional visits or phone calls by sleep specialist if doubts about a patient's compliance or willingness to continue with the therapy.; Standard group care plus: Involvement of the patient's partner or family necessary. Extra education on sleep apnea and CPAP by sleep specialists via a 15-min videotape. 10- to 15-min lecture from the sleep clinic's nurses after CPAP titration study. Phone calls by nurses at 2 and 7 days. Early review of patients by sleep specialists at 15 and 30 days. Home visits by sleep nurses, if there doubts about a patients adherence
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Synthetic Male Condom Slippage-Breakage Study
Condition: Contraceptive; Sexually Transmitted Diseases
MeSH terms: Sexually Transmitted Diseases
Study type: Interventional

Summary: 
      This is a multi-site, double-blind, crossover, randomized phase II study to evaluate the
      functional performance of a synthetic male condom as compared to a marketed latex condom.
    

Detailed description: 
      Approximately 300 heterosexual monogamous couples not at risk of pregnancy or transmission of
      sexually transmitted infections (STI) will be recruited to use both the test (synthetic)
      condom and a control (latex) condom. Couples will be given 4 condoms of one type (randomly
      determined) to use over a two week period, followed by 4 condoms of the other type to be used
      over the next two week period. The number of clinical failures (either condom breaks or
      completely slips off the penis) for each condom type will be compared to determine whether
      the test condom is non-inferior to the control condom. The study plan is based on
      International Standards Organization (ISO) guidance document ISO 29943-1 with the action
      standard set by synthetic condom standard ISO 23409.
    

Intervention name(s): Test Product; Control Product
Intervention type(s): Device; Device
Intervention description(s): Synthetic Male Condom; Latex Male Condom
Other intervention name(s): Synthetic Male Condom; Latex Male Condom
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Synthetic Male Condom; Slippage-Breakage Study; ISO 29943-1
Parathyroidectomy in Endstage Renal Disease
Condition: Endstage Renal Disease
MeSH terms: Kidney Diseases; Kidney Failure, Chronic
Study type: Interventional

Summary: 
      To test the hypothesis that total parathyroidectomy retards cardiovascular calcification,
      improves bone mineral density, reduces cardiac hypertrophy and arterial stiffening in
      end-stage renal disease patients on maintenance dialysis.
    

Detailed description: 
      Secondary hyperparathyroidism (SHPT) in patients with end-stage renal disease contributes to
      increased cardiovascular morbidity and mortality via different mechanisms. Uncontrolled
      hyperparathyroidism is associated with left ventricular hypertrophy and has been implicated
      in the development of cardiac interstitial fibrosis and diastolic dysfunction.
    

Intervention name(s): parathyroidectomy
Intervention type(s): Procedure
Intervention description(s): total parathyroidectomy with forearm autografting
Other intervention name(s): total parathyroidectomy with forearm autografting
Intervention model: Single Group Assignment
Intervention model description: Parathyroidectomy group versus natural disease control group
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: parathyroidectomy; cardiovascular; bone; endstage renal disease
A Study of Adjunctive Aripiprazole in Patients With Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial is a 14 week, randomized, double-blind, placebo controlled study, to assess the
      safety and efficacy of aripiprazole as adjunctive treatment to an ongoing antidepressant
      treatment in patients with Major Depressive Disorder.
    


Intervention name(s): Antidepressant + Placebo; Antidepressant + Aripiprazole
Intervention type(s): Drug; Drug
Intervention description(s): Antidepressant Caps/Tablets Placebo Tablets, Oral, 2-20 mg Placebo, once daily, 6 weeks following an 8 week Prospective Treatment (Baseline) Phase.; Antidepressant Caps/Tablets Aripiprazole Tablets, Oral, 2-20 mg Aripiprazole, once daily, 6 weeks following an 8 week Prospective Treatment (Baseline) Phase.
Other intervention name(s): Abilify
Intervention MeSH terms: Aripiprazole; Antidepressive Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The Efficacy of Computerized Cognitive Remediation Therapy for Chronic Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      The study group received antipsychotic drugs combined with Computerized Cognitive Remediation
      Therapy (CCRT) for 4 times/week for 45 minutes each time. The control group only received
      antipsychotic drugs. For a total of 12 weeks. Brain Derived Neurotrophic Factor (BDNF) and
      Tropomyosin-related kinase B (Trk B) genes in peripheral blood were detected in both groups
      before and after treatment. Clinical symptoms and executive function assessment were
      performed in both groups before and after treatment. The relevance of genes and their effects
      on downstream protein expression levels led to a molecular genetic mechanism for the efficacy
      of Computerized Cognitive Remediation Therapy (CCRT) .
    

Detailed description: 
      Among the cognitive disorders of chronic schizophrenia, the most reported is the executive
      dysfunction of the prefrontal lobe. There is increasing evidence that Computerized Cognitive
      Remediation Therapy (CCRT) has a significant improvement in the implementation of
      schizophrenia, but the specific mechanism is unknown. Therefore, this study plans to select
      154 patients with chronic schizophrenia who were hospitalized for a long time. They were
      randomly divided into two groups. The study group received antipsychotic drugs combined with
      Computerized Cognitive Remediation Therapy (CCRT) for 4 times/week for 45 minutes each time.
      The control group only received antipsychotic drugs. For a total of 12 weeks. brain-derived
      neurotrophic factor (BDNF) and tyrosine receptor kinase B(TRK-B) genes in peripheral blood
      were detected in both groups before and after treatment. Clinical symptoms and executive
      function assessment were performed in both groups before and after treatment. The relevance
      of genes and their effects on downstream protein expression levels led to a molecular genetic
      mechanism for the efficacy of Computerized Cognitive Remediation Therapy (CCRT).
    

Intervention name(s): Cognitive Remediation Therapy; Clozapine
Intervention type(s): Other; Drug
Intervention description(s): Through computer information technology, using error-free, procedural learning, speech enhancement and a series of targeted computer programmatic cognitive correction tasks, patients can gradually improve problem solving and information processing capabilities, thereby improving their recognition function.; the course of disease is more than 2 years, the condition is stable for more than one month
Other intervention name(s): CCRT; CLZ
Intervention MeSH terms: Clozapine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Role of Systemic Inflammation in Increase of Cardio-vascular Risk in Chronic Obstructive Pulmonary Disease
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Inflammation
Study type: Interventional

Summary: 
      The purpose is to study the correlation between systemic inflammation (serum levels of CRP,
      IL-1beta, IL-6 and TNF-alpha) or hyperhomocysteinemia and the increase of mortality, in a
      representative cohort of patients with chronic obstructive pulmonary disease (COPD).

      Secondary purposes are:

        1. To confirm the increase of cardiovascular mortality and the importance of cardiovascular
           morbidity in patients with COPD,

        2. To establish the role of various genetic polymorphisms in the correlation between
           systemic inflammation and cardiovascular disorders observed in COPD,

        3. To search for acceleration of aging of cardiovascular system evaluated with carotid
           intima-media thickness when systemic inflammation markers are increased,

        4. To study the correlation between COPD risk factors (tobacco and other food factors),
           change of respiratory functional data and cardiovascular morbi-mortality. In this study
           cardiovascular morbi-mortality is defined by following disorders: ischemic cardiopathy,
           left-sided heart failure, cardiac arrhythmia and cerebrovascular accident. Diagnosis is
           confirmed with standard techniques and independently of this study. Results of clinical
           examination, ECG, echocardiography and /or brain scanner will be collected.
    


Intervention name(s): Questionnaires about food habits and tobacco; Spirometry; Carotid echography; Blood sample
Intervention type(s): Other; Other; Other; Other
Intervention description(s): for genetic polymorphism analysis, CRP, homocysteine and cytokine tests, glycemia and dyslipidemia analyses
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: systemic inflammation
Subcutaneous Rehydration Compared to Intravenous Rehydration
Condition: Dehydration
MeSH terms: Dehydration
Study type: Interventional
Phase: Phase 4

Summary: 
      Randomized (1:1 ratio) study of subcutaneous (SC) versus intravenous (IV) fluid rehydration
      in mildly to moderately dehydrated pediatric patients.
    

Detailed description: 
      This is a prospective, randomized (1:1 ratio), open-label, parallel group, multicenter,
      multi-national, study of SC versus IV fluid rehydration in mildly to moderately dehydrated
      pediatric patients treated in the Emergency Department (ED), inpatient pediatric unit, and/or
      outpatient urgent care facility. It is expected that up to 186 patients, in order to achieve
      148 evaluable patients, will be randomized in a 1:1 ratio to receive isotonic fluid
      rehydration by either SC administration with hylenex (150 Units) or IV without hylenex.
    

Intervention name(s): recombinant human hyaluronidase
Intervention type(s): Drug
Intervention description(s): 150 Units in 1 mL
Other intervention name(s): Hylenex
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pediatric; hylenex; subcutaneous infusion; hyaluronidase; rHuPH20; recombinant human hyaluronidase
Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine Administered as a Booster Dose
Condition: Tetanus; Diphtheria; Haemophilus Influenzae Type b; Hepatitis B; Poliomyelitis; Acellular Pertussis; Diphtheria-Tetanus-aPertussis-Hepatitis B-Poliomyelitis-Haemophilus Influenzae Type b-Neisseria Meni
MeSH terms: Hepatitis A; Influenza, Human; Hepatitis B; Tetanus; Diphtheria; Poliomyelitis; Hepatitis; Tetany
Study type: Interventional
Phase: Phase 2

Summary: 
      The current trial will evaluate the safety and immunogenicity of GSK Biologicals' GSK2202083A
      vaccine when administered as a booster dose following priming in the first year of life with
      the same vaccine.

      This protocol posting deals with objectives & outcome measures of the booster phase. The
      objectives & outcome measures of the primary phase are presented in a separate protocol
      posting (NCT number = NCT00970307).
    


Intervention name(s): GSK2202083A vaccine; Infanrix hexa™; Menjugate™; NeisVac-C™; Synflorix™
Intervention type(s): Biological; Biological; Biological; Biological; Biological
Intervention description(s): Intramuscular, one dose.; Intramuscular, one dose.; Intramuscular, one dose.; Intramuscular, one dose.; Intramuscular, one dose.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: booster vaccination; combined vaccine
Differential Diagnosis Between Parkinson's Disease and Multiple System Atrophy Using Digital Speech Analysis
Condition: Parkinson Disease; MSA - Multiple System Atrophy
MeSH terms: Parkinson Disease; Multiple System Atrophy; Shy-Drager Syndrome; Atrophy
Study type: Interventional

Summary: 
      Parkinson's disease (PD) is the second most common neurodegenerative disease. Multiple system
      atrophy (MSA) is a relentlessly progressing rare neurodegenerative disease of unknown
      etiology. In early stages of the disease, PD and MSA symptoms are very similar, particularly
      MSA-P where Parkinsonism predominates. The differential diagnosis between MSA-P and PD can be
      very challenging in early disease stages, while early diagnostic certitude is important for
      the patient because of the diverging prognosis. Voice disorders are a common early symptom in
      both diseases and of different origin. The ambition and the originality of this project are
      to develop a digital voice-based tool for objective discrimination between PD and MSA-P.
    

Detailed description: 
      Given the clinical similarity between PD and MSA-P in early disease stages and the severity
      of the prognosis of MSA-P, it would be very useful to have objective tools to assist in the
      differential diagnosis between both disorders. Since dysarthria is a common early symptom in
      both diseases and of different origin, the innovative goal of this project is to use
      dysarthria, through a digital processing of voice recordings of patients, as a vehicle to
      distinguish between PD and MSA-P in early disease stages.

      The team will build a corpus of voice samples of patients with both diseases and a recent
      diagnosis (less than 4 years) and controls. This corpus will consist in sustained vowels,
      utterances of a standard text and spontaneous speech. The recordings will be performed using
      a high quality digital recorder (H4n) and the DIANA and EVA-2 workstations. DIANA is a
      state-of-the-art system dedicated to pathological voice recording and analysis.

      An electroglottograph (EGG), a non-invasive device, will be also used in conjunction with the
      recordings to provide the ground truth of glottal opening and closure instants during
      utterances. The use of an EGG can be very useful given that OGI and GCI provide valuable
      information about the voice short-time dynamics.
    

Intervention name(s): voice recordings
Intervention type(s): Procedure
Intervention description(s): A digital processing of voice recordings (from 30 to 45 minutes) will be performed for each participant, using a high quality digital recorder: the DIANA (computerized device of acoustic analysis) and the EVA-2 workstations (assisted Evaluation system Voice).
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Exploratory comparative multicentric study.
Masking: None (Open Label)
Primary purpose: Diagnostic
Short-term Fasting as an Enhancer of Chemotherapy: Pilot Clinical Study on Colorectal Carcinoma Patients
Condition: Fasting
Study type: Interventional

Summary: 
      This study will evaluate the ability of short-term fasting to reduce chemotherapy toxicity
      and enhance anti-tumour response in patients with colorectal carcinoma subjected to
      chemotherapy.
    

Detailed description: 
      Fasting for 24-48 hours during chemotherapy improves the response of the immune system
      against tumors and reduces chemotherapy toxicity through yet unknown mechanisms. The
      investigators have found that fasting induces the activation of p21, a protein that stops
      cell proliferation and plays important immune roles. The investigators hypothesize that p21
      induction with short-term fasting enhances the immune anti-tumour response and reduces
      chemotherapy toxicity. To test this, half of the colorectal carcinoma (CRC) participants will
      follow 48 hours of fasting, 24 before and 24 after chemotherapy, under constant and
      specialized nutritional supervision. While the other half will follow a standard diet. A
      complete blood immunological profile at each chemotherapy cycle will be generated in
      collaboration with expert cytometrists, and gene expression, biochemical parameters, tumor
      evolution and toxicity markers will be measured. The investigators will (1) perform a
      complete analysis of immune cells to characterize the immune effects of fasting during
      chemotherapy; (2) analyze the effects of fasting on genes, metabolites and other molecules,
      to identify the responsible biological mechanisms, focusing on p21; (3) assess the reduction
      of chemotherapy toxicity in patients of colorectal carcinoma subjected to short-term fasting
      during chemotherapy.

      Our project will further explore a safe, inexpensive, relatively unexplored and powerful
      nutritional intervention that can improve the quality of life and survival rates of millions
      of cancer patients: short-term fasting. Also, our project will have an important scientific
      impact, since previous reports have not yet described a clear mechanism explaining the
      beneficial effects of short-term fasting with chemotherapy
    

Intervention name(s): Fasting
Intervention type(s): Procedure
Intervention description(s): Food intake restriction
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Short-term Fasting; Colorectal Cancer; Chemotherapy; Toxicity; Immune response
Efficacy and Safety of 3 Doses of Tiotropium Compared to Placebo in Adolescents (12 to 17 Yrs) With Moderate Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this trial is to evaluate the efficacy and safety of tiotropium 1.25
      mcg (2 actuations of 0.625 mcg), tiotropium 2.5 mcg (2 actuations of 1.25 mcg) and tiotropium
      5 mcg (2 actuations of 2.5 mcg) once daily in the evening delivered by the Respimat inhaler
      in adolescents (12 to 17 yrs) with moderate persistent asthma, compared to placebo and on top
      of maintenance therapy with an inhaled corticosteroid controller medication. It is a
      randomised, double-blind, placebo-controlled Phase II trial with incomplete cross-over
      design. Patients need to be still symptomatic, i. e. not fully controlled with their
      maintenance treatment.
    


Intervention name(s): Tiotropium bromide; tiotropium bromide; tiotropium bromide; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): inhalation solution, dose of 1.25 mcg (2 puffs of 0.625 mcg); inhalation solution, dose of 2.5 mcg (2 puffs of 1.25 mcg); inhalation solution, dose of 5 mcg (2 puffs of 2.5 mcg); placebo inhalation solution
Intervention MeSH terms: Bromides; Tiotropium Bromide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Drug-drug Interaction of BI 201335 and Microgynon
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis C; Hepatitis C, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will investigate possible effect of multiple oral doses of BI 201335 on the steady
      state pharmacokinetics of ethinylestradiol and levonogestrel
    


Intervention name(s): levonorgestrel; Ethinylestradiol; levonorgestrel; BI 201335; Ethinylestradiol
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): multiple doses; multiple doses; multiple doses; multiple doses; multiple doses
Intervention MeSH terms: Levonorgestrel; Ethinyl Estradiol
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy, Safety and Long-term Prognosis of Imatinib in Patients Newly Diagnosed With Chronic Myelogenous Leukemia (Chronic Phase)
Condition: Chronic Myelogenous Leukemia in Chronic Phase
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will assess the safety and efficacy of imatinib in newly enrolled previously
      untreated patients with chronic phase CML.
    


Intervention name(s): Imatinib
Intervention type(s): Drug
Intervention MeSH terms: Imatinib Mesylate
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic Myelogenous Leukemia; Imatinib; CML