bioihbjkbjnl/mcl2 huggingface dataset:
Repeated Partial Sleep Deprivation to Augment SSRI Response in Depression
Condition: Depression
MeSH terms: Sleep Deprivation; Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to determine whether changing sleep patterns improves response to
      an antidepressant medication.
    

Detailed description: 
      Depression is common and associated with social and economic costs. Although antidepressant
      medications are an effective treatment for depression, it can take as long as 6-8 weeks
      before symptoms improve, and 20-35% of individuals who use antidepressants still experience
      depression symptoms.

      New treatments that accelerate response to antidepressants are important to reduce the burden
      of depression. The objectives of the proposed study are (1) to evaluate the effects of
      partial sleep deprivation compared to no sleep deprivation for improving response to 8 weeks
      of fluoxetine 20-40 mg treatment and (2) to examine the underlying sleep mechanisms of
      treatment response.

      Participants who are eligible for the study will be randomly assigned to one of three sleep
      schedules for a 2-week period while taking fluoxetine: no sleep deprivation (8 hours time in
      bed), late bedtime (6 hours time in bed, with 2 hour bedtime delay) or early risetime (6
      hours time in bed, with 2 hour advancement of rise time). Participants will spend a total of
      7 nights in our sleep laboratory and will be followed on fluoxetine for an 8-week period.
    

Intervention name(s): Sleep scheduling; Fluoxetine
Intervention type(s): Behavioral; Drug
Intervention description(s): 8 hours vs. 6 hours time in bed for two weeks, with either 2 hour advance of risetime, or 2 hour delay of bedtime; 20-40 mg fluoxetine daily for 8 weeks
Other intervention name(s): Prozac
Intervention MeSH terms: Fluoxetine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: depression; sleep; treatment
A Study Exploring the Use of Challenge Agents in Healthy Volunteers or Participants With a Disease of Interest
Condition: Healthy
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this study is to characterize the biological response in vivo to challenge
      agents (vaccines, antigen, drug, or mechanical challenges); to assess the safety and
      tolerability of the challenge agent and to characterize the immune response in skin elicited
      in vivo in healthy volunteers using an ultraviolet B (UVB) challenge.
    


Intervention name(s): UVB Challenge
Intervention type(s): Radiation
Intervention description(s): UVB challenge will be administered dermally through Lumera Phototherapy System.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
"Reversibility of Cardiovascular Injury With CPAP Use: Mechanisms Involved"
Condition: Sleep Apnea, Obstructive; Hypoxia; Hypercapnia; Sleep Disorders; Obesity; Hypertension; Coronary Artery Vasospasm; Right Ventricular Overload; Left Ventricular Function Systolic Dysfunction; Ventricular Hypertrophy
MeSH terms: Sleep Apnea, Obstructive; Sleep Wake Disorders; Coronary Vasospasm; Hypoxia; Hypertrophy; Hypercapnia
Study type: Interventional

Summary: 
      The purpose of this study is to determine the factors that are associated with improved
      cardiovascular function with the use of CPAP therapy on subjects diagnosed with moderate to
      severe obstructive sleep apnea.
    

Detailed description: 
      We will monitor non-invasively changes in arterial stiffness, cardiac mass, pulmonary
      pressures, endothelial function, etc. We will also assess the reversibility of these changes
      after only 5-7 days of not using the CPAP mask. In a subgroup of subjects we will explore
      changes in coronary flow response after 12 weeks of CPAP use compared with baseline.
    

Intervention name(s): Clinically prescribed CPAP therapy
Intervention type(s): Other
Intervention description(s): CPAP as prescribed by attending physician
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of the Pupil Dilation Reflex in Response to Noxious Stimulation in Anaesthetized Children. A Proof of Concept Trial
Condition: Pain; Monitoring, Intraoperative
MeSH terms: Mydriasis
Study type: Interventional

Summary: 
      After conduction a pilot study, pupillary dilation reflex (PDR) is measured in response to
      nociceptive stimulation perioperatively in infants, children and adolescents.
    

Detailed description: 
      An infrared camera of the video pupillometer measures the pupillary dilation reflex (PDR) in
      response to incremental nociceptive stimuli. The PDR is a robust reflex, even in patients
      under general anesthesia, and may provide a potential evaluation of the autonomous
      nociceptive circuit. American Society of Anesthesiologists (ASA) classification I or II
      patients from the age of 28 days till 18 years undergoing elective surgery under general
      anesthesia are recruited. Enrolled patients perioperative undergo PDR measurement at 2
      different standardized times (before and after opioid administration) generated by an inbuilt
      pupillary pain index (PPI) protocol. PPI, as a surrogate for nociception includes noxious
      stimulations from 10 up to 60 milli ampere (mA) until pupil dilation is larger than 13% from
      baseline diameter. Therefore, no inappropriate high stimulation is executed.
    

Intervention name(s): PDR measurement
Intervention type(s): Device
Intervention description(s): PDR measurement at two standardized times perioperatively:
Anesthetized subject by sevoflurane sedation until a minimum alveolar concentration (MAC) of at least 1,5 is reached
Administration of fentanyl 2µg/kg, in the absence of adjustments in sedation depth
Other intervention name(s): PPI assessment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
ANI-guided Intraoperative Analgesia vs Conventional Intraoperative Analgesia
Condition: Postoperative Pain; Analgesia; Surgery
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      This study evaluates the effects of Analgesia Nociception Index (ANI)-guided intraoperative
      analgesia on postoperative pain in patients undergoing open gynecologic surgery.
    

Detailed description: 
      Postoperative pain is one of the most common postoperative complications and is significantly
      associated with patient's quality of recovery. Analgesia Nociception Index (ANI) is known to
      analyze the high frequency component of heart rate variability in relation to respiratory
      frequency, providing the objective information on the degree of pain. However, most previous
      studies conducted by using ANI were observational studies or small-sized randomized
      controlled studies. In the present study, the investigators aimed to evaluate the effects of
      ANI-guided intraoperative analgesia on moderate-to-severe postoperative pain by performing
      randomized controlled study.
    

Intervention name(s): ANI-guided intraoperative analgesia; Conventional intraoperative analgesia
Intervention type(s): Procedure; Procedure
Intervention description(s): Intraoperative analgesia is performed by controlling the effect-site concentration of remifentanil to maintain 50-70 of ANI.; Intraoperative analgesia is performed by controlling the effect-site concentration of remifentanil at the discretion of attending anesthesiologists based on hemodynamic parameters.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Correlation Between Intestinal Parasites and Serum Level of Eosinophils and IgE in Individuals With HIV or AIDS
Condition: HIV Infections
MeSH terms: Intestinal Diseases, Parasitic
Study type: Observational

Summary: 
      Correlation between intestinal parasites and serum level of eosinophils and IgE in
      individuals with HIV or aids attended at clinical hospital of the Botucatu Medical
      School-UNESP
    

Detailed description: 
      The present study correlates intestinal parasitism and levels of eosonophils and of serum
      IgEs in patients attended at the C.H. of the School of Medicine - Botucatu/UNESP. Thirty
      adult patients with AIDS were analyzed in the use of HAART, aged 42 ±11 years, 14 (46.7%)
      male, excluding those that had used anthelminthics 30 days prior to collection. Socioeconomic
      questionaires were applied and 3 samples of feces were taken for parasitological exams
      (TF-test® method) and 5 ml of blood for counting eosinophils (automated hematological
      counter, Pentra 80, ABX) and IgE doses (equipment BN-100, Dade-Behring). The index of
      parasites was 10%, with E.nana (3.3%), E.coli (3.3%) and B.hominis (3.3%). Parasitized
      individuals were from an urban region with complete basic sanitation and good socioeconomic
      level. Normal eosinphil values were found in all samples and increased IgE values in 1
      (33.3%) sample. The index of parasites was low due to good socioeconomic level and disease
      control. Augmented IgE levels corroborate the literature, which reports an increase
      characteristic of immune response in the face of parasitic infections in individuals with HIV
      or AIDS. In conclusion, new studies should be undertaken to evaluate the level of eosinophils
      associated with cytokines to obtain a better understanding of this correlation.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        primary care clinic
      
Biospecimen description: 
      Sample of Blood Sample of Feces
    
Keywords: HIV; aids; intestinal parasites; eosinophils; immunoglobulins; HIV/aids; Treatment Experienced
Inhibition of Gastric Acid is the Key to Satisfactory Relief of Symptoms With Esomeprazole in NUD Patients
Condition: Indigestion
MeSH terms: Dyspepsia
Study type: Interventional
Phase: Phase 2

Summary: 
      Inhibition of gastric acid is the key to satisfactory relief of symptoms with esomeprazole in
      NUD patients
    

Detailed description: 
      Enrolled patients will undergo 24h gastric pH monitoring and subsequently (if gastric pH
      drops below pH 4 during 24h monitoring) will be randomized to receive placebo (40 mg QD) or
      esomeprazole (40 mg QD) for 16 weeks of therapy. 24h gastric pH monitoring will be repeated
      2nd and 3rd time in all participating patients at the end of 4th and 8th weeks of therapy.
      Additionally, in all participants NUD symptoms will be re-assessed at the end of 4th, 8th,
      12th and 16th weeks of therapy.
    

Intervention name(s): Esomeprazole; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Esomeprazole 40 mg QD; Placebo
Other intervention name(s): Nexium
Intervention MeSH terms: Esomeprazole
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Epigastric Pain; Non-Ulcer Dyspepsia (NUD)
The Effect of Adaptive Servo Ventilation and Oxygen Therapy in Central Sleep Apnea Patients
Condition: Chronic Heart Failure; Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Central; Heart Failure
Study type: Interventional

Summary: 
      The aim of this study is to compare the effects of Adaptive Servo Ventilation (Bipap® auto SV
      Advanced) and oxygen therapy in chronic heart failure patients complicated with central sleep
      apnea.
    

Detailed description: 
      Central sleep apnea(CSA) is associated with chronic heart failure(CHF). At present, both of
      nocturnal oxygen therapy and adaptive servo ventilation(ASV) are recognized as effective
      modalities. However,in fact, majority of CHF patients are complicated not only with CSA but
      with obstructive sleep apnea(OSA). Recently, Philips developed Bipap® auto SV Advanced for
      such patients. It has auto-CPAP function as the modality of OSAS, in addition to ASV
      function. The present study is prospective randomised study to compare the effects of
      nocturnal oxygen therapy and Bipap® auto SV Advanced.
    

Intervention name(s): Adaptive servo ventilation; Nocturnal oxygen
Intervention type(s): Device; Device
Intervention description(s): Nocturnal use of Adaptive servo ventilation; Nocturnal use of oxygen
Other intervention name(s): Bipap® auto SV Advanced (Philips Respironics)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic heart failure; Central sleep apnea; Obstructive sleep apnea; Adaptive servo ventilation
Oxaliplatin, Capecitabine, and Cetuximab in Treating Patients With Advanced Liver Cancer
Condition: Liver Cancer
MeSH terms: Liver Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as oxaliplatin and capecitabine, work in
      different ways to stop the growth of tumor cells, either by killing the cells or by stopping
      them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in
      different ways. Some block the ability of tumor cells to grow and spread. Others find tumor
      cells and help kill them or carry tumor-killing substances to them. Giving chemotherapy
      together with a monoclonal antibody may kill more tumor cells.

      PURPOSE: This phase II trial is studying how well giving oxaliplatin and capecitabine
      together with cetuximab works in treating patients with advanced liver cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the response rate in patients with advanced hepatocellular carcinoma and
           hepatic dysfunction treated with oxaliplatin, capecitabine, and cetuximab.

      Secondary

        -  Determine the safety of this regimen in these patients.

        -  Determine the overall survival of patients treated with this regimen.

        -  Determine the time to tumor progression in patients treated with this regimen.

      OUTLINE: This is an open label, nonrandomized study.

      Patients receive oral capecitabine twice daily on days 1-14, cetuximab IV over 60-120 minutes
      on days 1, 8, and 15, and oxaliplatin IV over 120 minutes on day 1. Treatment repeats every
      21 days in the absence of disease progression or unacceptable toxicity.

      After completion of study treatment, patients are followed at 3-4 weeks and then every 3
      months thereafter.
    

Intervention name(s): cetuximab; capecitabine; oxaliplatin
Intervention type(s): Biological; Drug; Drug
Intervention description(s): 250 mg/m2, intravenously, once per week; 850 mg/m2, orally, twice daily (dose rounded to accommodate 150 mg and 500 mg tablet sizes. Capecitabine given on days 1-14 of 21 day cycle.; 130 mg/m2, intravenously on Day 1 of each 21 day cycle
Other intervention name(s): Erbitux; Xeloda; Eloxatin
Intervention MeSH terms: Capecitabine; Oxaliplatin; Cetuximab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: advanced adult primary liver cancer; localized unresectable adult primary liver cancer; recurrent adult primary liver cancer; adult primary hepatocellular carcinoma
Pilot Study of Metformin for Patients With Fanconi Anemia
Condition: Fanconi Anemia
MeSH terms: Fanconi Syndrome; Anemia; Fanconi Anemia
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a single institution, open-label, single arm pilot study of Metformin in patients
      with Fanconi Anemia (FA) and cytopenias with the primary endpoint of hematologic response.
      This study will also assess safety, tolerability, and the biologic effects of Metformin in
      patients with FA.
    


Intervention name(s): metformin HCl
Intervention type(s): Drug
Intervention description(s): Receive metformin HCl
Intervention MeSH terms: Metformin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Fanconi Anemia; Metformin
Khalifa Acute Effects
Condition: Totally Ruptured Anterior Cruciate Ligament in the Knee
Study type: Interventional

Summary: 
      The primary hypothesis is that Khalifa's therapy has different acute effects in various organ
      systems i.e. proprioceptive, neuro-muscular, endogenous dopamine system, etc. These effects
      might indicate the pathway of the therapy.
    

Detailed description: 
      According to our previous study that evaluated the efficacy of Khalifa's therapy the
      investigators have seen that the therapy has acute effects which resulted in better knee
      function and later even in better healing of the ACL injury. This study should clear exactly
      which effects and pathways are involved in the therapy from multiple (interdisciplinary)
      point of views. Therefore the investigators will measure parameters that might be associated
      with this special technique directly before and after the therapy.
    

Intervention name(s): Khalifa Therapy
Intervention type(s): Other
Intervention description(s): One hour of Khalifa's therapy which is specially applied pressure to the skin.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: ACL; Knee; Ligament; Cruciate; Anterior
Home Based Massage and Relaxation for Sickle Cell Pain
Condition: Sickle Cell Disease
MeSH terms: Anemia, Sickle Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to compare the effects of in-home, family-administered massage
      and in-home relaxation training on measures of physical status and health care utilization in
      a sample of African American adolescents age 15 years and older and adults with chronic pain
      associated with sickle cell disease who have been randomly assigned to six sessions of either
      family-administered massage or progressive muscle relaxation training.
    


Intervention name(s): massage; relaxation
Intervention type(s): Procedure; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Sickle Cell Pain; Sickle Cell Disease; Chronic Pain; Alternative Medicine/Therapy; Complementary Medicine; Massage Therapy; Relaxation Technique; Home-based Therapy
Phase 1 Food Effect Study for Alicaforsen Tablets
Condition: IBD
Study type: Interventional
Phase: Phase 1

Summary: 
      Phase 1 study to compare the effect of food on alicaforsen tablet.
    

Detailed description: 
      A study on healthy male vounteers in a phase 1 unit. Alicaforsen tablets are gievn in a fed
      and fasted state
    

Intervention name(s): Alicaforsen
Intervention type(s): Drug
Intervention description(s): Alicaforsen tablet
Intervention MeSH terms: Alicaforsen
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Segmental Bronchoalveolar Lavage
Condition: Asthma; Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Fibrosis
Study type: Observational

Summary: 
      Bronchoalveolar lavage (BAL) is a diagnostic and therapeutic procedure conducted by placing a
      small fiberoptic scope into the lung of a patient, and injecting sterile water (saline) into
      the lung and removing the fluid. The sterile solution removed contains secretions, cells, and
      protein from the lower respiratory tract. This sample can be analyzed to provide more
      information about possible disease processes going on in the lungs.

      This protocol will be used to perform BAL, bronchial brushing, and bronchial wall biopsy in
      normal volunteers and patients with pulmonary disease. The samples collected during the study
      will be used to examine biochemical processes in the lung that may contribute to lung disease
    

Detailed description: 
      This protocol proposes to perform bronchoalveolar lavage, bronchial brushing and bronchial
      wall biopsy in research volunteers and in patients with pulmonary disease to evaluate the
      cellular components of normal and diseased lungs. This research study will help to improve
      our understanding of pathogenic mechanisms in the lung during progression of pulmonary
      disease.
    

Keywords: Cystic Fibrosis; Healthy Volunteers; Asthma; Normal Volunteer; Chronic Lung Disease
Time RestrIcted Feeding For Improving Diabetes Risk (TRIFFID)
Condition: Type2 Diabetes; Obesity
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      This study will explore the effects of eight weeks of time-restricted feeding (TRF) on body
      weight and composition, glycaemic control, 24-hour glucose profiles, glucoregulatory
      hormones, and cardiovascular risk in men at high risk of type 2 diabetes. The investigators
      hypothesise that 8 weeks of TRF will reduce body weight, improve body composition, improve
      glycaemic control and blood lipid profiles. The potential mechanism will be explored in terms
      of the changes in gene expression patterns and multi-omics level (e.g., adipose tissue
      transcriptome, blood proteome).
    

Detailed description: 
      Following a 2 week baseline monitoring phase (food intake by smartphone APP, activity by
      accelerometer, glucose by continuous glucose monitor), participants will attend the metabolic
      clinic for testing (visit 0). Body weight, body composition (by DEXA), and blood pressure
      will be assessed. Blood and adipose tissue samples will be collected over 24-hour period for
      assessment of glucose, insulin, glucoregulatory hormones, blood lipids and adipose tissue
      transcriptome. Glucose and insulin responses to a standardised breakfast will be measured.
      All food will be provided for 3 days prior to the metabolic visit. Following visit 0,
      participants will be instructed to eat only within a 10-hour time frame each day for 8 weeks.
      Participants may self-select the precise window that best suits their lifestyles, however any
      food and drink must be consumed at least 3 hours prior to their usual bedtime. 24-hour
      glucose profiles, activity and food intake will be measured again at week 6-8. At the end of
      the 8 weeks, participants will return for a follow-up metabolic visit, identical to that at
      visit 0, except foods are provided with the 10h time frame.
    

Intervention name(s): TRF
Intervention type(s): Behavioral
Intervention description(s): Participants will be instructed to consume their habitual diet within a self-selected 10 hour period every day.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention