bioihbjkbjnl/mcl2 huggingface dataset:
Equivalence of a Human-Powered Nebulizer to an Electric Nebulizer
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      This is an equivalence study comparing an electric nebulizer with a human-powered
      nebulizer--one that does not need electricity--in the treatment of mild to moderate asthma
      exacerbations in a regional clinic in San Salvador, El Salvador.
    

Detailed description: 
      The study design is to treat individuals suffering from mild to moderate exacerbations of
      asthma with nebulized salbutamol (2.5mg). Subjects will receive nebulization using either an
      electric nebulizer compressor or a human-powered nebulizer compressor. Improvement in peak
      expiratory flow will be the primary endpoint. Blood oxygenation levels as measured by pulse
      oximetry will be a secondary endpoint of the trial.
    

Intervention name(s): Human-Powered Nebulizer
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Asthma; Nebulizers; Salbutamol; Developing Countries
Vaccine Therapy in Treating Patients With Stage I, Stage II, or Stage IIIA Non-small Cell Lung Cancer or With Stage I or Stage II Mesothelioma
Condition: Lung Cancer; Malignant Mesothelioma
MeSH terms: Lung Neoplasms; Mesothelioma; Mesothelioma, Malignant
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Vaccines made from a person's tumor may help the body build an immune response to
      kill tumor cells.

      PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who
      have undergone surgery to remove stage I, stage II, or stage IIIA non-small cell lung cancer
      or stage I or stage II mesothelioma.
    

Detailed description: 
      OBJECTIVES: I. Define the immunological parameters of cytolytic T cell and T helper cell
      activity associated with skin testing and vaccination with autologous lung tumor associated
      antigen and detoxPC in patients with curatively resected stage I, II, or IIIA non-small cell
      lung cancer (NSCLC) or stage I or II mesothelioma. II. Evaluate any responses associated with
      an enhanced antitumor immune status in this patient population with this treatment regimen.

      OUTLINE: Patients undergo delayed type hypersensitivity skin testing with autologous tumor
      associated antigen (TAA) and memory antigens (i.e., Monilia, PPD, and Trichophyton)
      intradermally at 1-4 weeks following surgical tumor resection. At week 4-9, patients receive
      low dose cyclophosphamide IV once. At 3 days following chemotherapy, patients receive
      autologous TAA with DetoxPC intradermally for up to 3 doses over 4 weeks. At 2-3 weeks
      following vaccination, patients undergo repeat skin testing. At week 6-12, patients with a
      positive skin test undergo biopsy of the skin test/vaccination site followed by leukapheresis
      at week 12-20 if T cells exhibit active antitumor reactivity. Patients with stable or
      regressive disease receive additional vaccination courses at week 20 and thereafter. Patients
      are followed for 5 years.

      PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study within 2 years.
    

Intervention name(s): lung tumor associated antigen; DetoxPC; chemotherapy; cyclophosphamide
Intervention type(s): Biological; Drug; Drug; Drug
Intervention MeSH terms: Cyclophosphamide
Primary purpose: Treatment
Keywords: stage I non-small cell lung cancer; stage II non-small cell lung cancer; localized malignant mesothelioma; stage IIIA non-small cell lung cancer
oVRcome - Self Guided Virtual Reality for Social Anxiety Disorder
Condition: Social Anxiety
MeSH terms: Anxiety Disorders; Phobia, Social
Study type: Interventional

Summary: 
      Social anxiety is characterised by excessive fear of being negatively judged, embarrassed or
      humiliated during social interactions and is common with a lifetime prevalence of 12.1%.
      Cognitive behavioural therapy is the first line of treatment, but people may not seek
      treatment due to a number of factors including the discomfort experienced in seeking help,
      inconvenience, and the experience of psychotherapy itself. With Virtual Reality (VR), users
      can have increased control in how gradually they expose themselves to social situations. In
      studies of VR in people with specific phobias, 76% of people prefer VR exposure to in vivo
      exposure. There is emerging evidence for the use of VR in social phobia.

      oVRcome, is a self-help VRET for social anxiety symptoms and specific phobias, that is
      delivered through a smartphone application (app) in combination with a low cost headset that
      holds the smartphone and uses 360º video.

      This study will evaluate the effectiveness of the oVRcome social anxiety program for social
      anxiety symptoms. We hypothesize that oVRcome will reduce social anxiety symptom severity
      over a 6-week treatment period compared to waiting-list control
    


Intervention name(s): oVRcome phone app with headset
Intervention type(s): Other
Intervention description(s): The intervention oVRcome is self-help VRET for social anxiety, that is delivered through a smartphone application (app) in combination with headset that holds the smartphone and uses 360º video. oVRcome includes 6 modules of psychoeducation, relaxation, mindfulness, cognitive techniques, exposure through VR, and a relapse prevention module which are aimed to be completed weekly.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
PCOS Treatment Using DLBS3233, Metformin, and Combination of Both
Condition: Polycystic Ovary Syndrome (PCOS); Insulin Resistance
MeSH terms: Polycystic Ovary Syndrome; Insulin Resistance; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a 3-arm, randomized, double-blind, double-dummy, and controlled clinical study over 6
      months of treatment to evaluate the metabolic and clinical efficacy as well as the safety of
      DLBS3233 alone, metformin and combination of both, in improving metabolic and reproductive
      parameters.
    

Detailed description: 
      There will be 3 groups of treatment (N = 186), each consist of 62 subjects, as the following:

        -  Treatment I : DLBS3233 100 mg once daily

        -  Treatment II : Metformin XR 750 mg twice daily

        -  Treatment III : DLBS3233 100 mg once daily and Metformin XR 750 mg twice daily.

      Laboratory examination to evaluate metabolic efficacy parameters will be performed at
      baseline, Month 3rd, and end of study (Month 6th).

      Clinical and laboratory examination to evaluate the reproductive efficacy parameters using
      trans-vaginal USG and biomarkers (such as reproductive hormones) will be performed at
      baseline to the end of study.

      Safety examination will be performed at baseline and end of study. Occurrence of adverse
      event will be observed along the study conduct.
    

Intervention name(s): DLBS3233; Metformin XR; Placebo metformin; Placebo DLBS3233
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Placebo metformin has the same ingredients with Metformin XR caplet, except that it does not contain the active substance (metformin).; Placebo DLBS3233 has the same ingredients with DLBS3233 capsule, except that it does not contain the active substance (DLBS3233).
Other intervention name(s): Inlacin; Glumin XR
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Polycystic ovarium syndrome; DLBS3233; metformin; insulin resistance; Female
Study Investigating Repeat Doses Of A New Medication (GSK159797) In Asthmatic Patients
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed to determine the efficacy and safety of a new long-acting beta-agonist
      for asthma patients (GSK159797) following dosing for 14 days.
    


Intervention name(s): GSK159797 (10, 15, and 20mcg); salbutamol; salmeterol 50mcg; placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): GSK159797 (10, 15, and 20mcg); salbutamol; salmeterol 50mcg; placebo
Other intervention name(s): GSK159797 (10; 15; and 20mcg); salbutamol; salmeterol 50mcg
Intervention MeSH terms: Albuterol; Salmeterol Xinafoate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Safety; Asthmatic patients; GSK159797; Efficacy
PPAR - Combination With Metformin
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Interventional
Phase: Phase 3

Summary: 
      A Phase 3, Randomized, Double-blind, Placebo Controlled, Multicenter Trial to Evaluate the
      Safety and Efficacy of BMS-298585 in Combination with Metformin Therapy in Subjects with Type
      2 Diabetes Who Have Inadequate Glycemic Control on Metformin Therapy Alone
    


Intervention name(s): Muraglitazar
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Metabolics Diabetes New Onset
Kinematics and Kinetics of Gait Perturbations in Young Healthy Adults
Condition: Balance Disorders
Study type: Interventional

Summary: 
      Investigators would like to examine, what are strategies for balance recovery in gait
      perturbations. Different perturbation types where used in the current study. The study
      involves the analysis of kinematic and kinetic parameters. Researchers hypothesize that
      research including young healthy adults would help to elaborate fall prevention program for
      seniors.
    


Intervention name(s): Reaction for gait perturbation
Intervention type(s): Diagnostic Test
Intervention description(s): Participants were subjected to four different perturbation types while walking on the treadmill:
left treadmill belt deceleration for right leg toe off
right treadmill belt deceleration for left leg toe off
left treadmill belt acceleration for right leg heel strike
right treadmill belt acceleration for left leg heel strike
Motion analysis was conducted to analyze effect of the intervention on gait.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: motek grail; balance; gait perturbation
Upright Position During First Stage of Labour
Condition: Effects of Movement
Study type: Interventional

Summary: 
      There are several physiological advantages for being upright during labour. These include the
      effect of gravity on the fetus within the uterus; reduced risk of aorto-caval compression
      this maximizes uterine blood ﬂow to the placenta and fetus during labour and more efficient
      contractions which lead to shorter first and second stage of labor. In addition, being
      upright during labour provide better alignment of the fetus; and increased pelvic outlet when
      the woman is in squatting and kneeling positions
    


Intervention name(s): assumed upright position during first stage of labor
Intervention type(s): Other
Intervention description(s): The study group assumed one of upright positions during first stage of labor, defined as walking , sitting, standing, kneeling & squatting positions )
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Health Services Research
Keywords: First stage of labor; Upright position; Labor outcomes
Effect of Diet on Men and Women With Genetic Alterations Associated With Abnormal Blood Tests
Condition: Dyslipidemia
MeSH terms: Dyslipidemias
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate different diets and the effects of blood measures or
      inflammation and endothelial function in association with genetics tending to abnormal blood
      test levels.
    


Intervention name(s): Diet
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diet; triglyceride; inflammation; Genetic polymorphism
Safety Evaluation of Inhaled Treprostinil Administration Following Transition From Inhaled Ventavis in Pulmonary Arterial Hypertension (PAH) Subjects
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a 24-month, multi-center, prospective, open-label, safety evaluation in PAH subjects
      following transition from a stable dose of inhaled iloprost (Ventavis).

      Subjects are to be evaluated for safety throughout the course of the study while secondary
      assessments will be conducted at Baseline, Week 6, Week 12, and Months 6, 12, 18 and 24
      following initiation of treprostinil sodium.
    


Intervention name(s): Inhaled treprostinil
Intervention type(s): Drug
Other intervention name(s): Tyvaso
Intervention MeSH terms: Treprostinil
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pulmonary arterial hypertension; PAH; treprostinil sodium; inhalation; ventavis; iloprost
Clinical Behavior of the Asqelio™ Trifocal Diffractive Intraocular Lens
Condition: Cataract
MeSH terms: Cataract
Study type: Observational

Summary: 
      The main objective of this study was to evaluate distance, intermediate, and near vision in
      patients who have undergone cataract extraction with bilateral implantation of a new
      hydrophobic trifocal diffractive intraocular lens (IOL) with a biospheric design, the Asqelio
      Trifocal IOL (AST Products, Inc., Billerica MA, USA), along with patient-reported outcomes
      (PRO). For that purpose the clinical information of 50 eyes from 25 patients was
      retrospectively analyzed 3 months after implantation
    


Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects are regular clinic patients submitted to bilateral conventional cataract surgery
        by phacoemulsification, who wanted to correct their refractive error and presbyopia, and
        thus were implanted with the trifocal IOL subject to study by common clinical practice
A Study of an Automated Insulin Delivery System in Adult Participants With Type 1 Diabetes
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The purpose of this early feasibility study is to assess the predictive low glucose suspend
      (PLGS) feature's safety, functionality and performance.
    


Intervention name(s): AID System; Insulin Lispro
Intervention type(s): Device; Drug
Intervention description(s): AID system; Individualized doses of insulin lispro administered via the AID system to maintain glycemic control, except during procedures designed to induce hyperglycemia and hypoglycemia.
Other intervention name(s): LY8888AU; LY275585
Intervention MeSH terms: Insulin Lispro
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
WS®1442 in Slightly Overweight Subjects
Condition: Overweight
MeSH terms: Overweight
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to test:

        1. Safety of 900 mg or 1800 mg of WS® 1442 per day in overweight subjects (BMI 25 to 29,9
           kg/m²)

        2. Pharmacodynamic effect of WS® 1442 on endothelial function versus nordic walking
           training in overweight subjects
    

Detailed description: 
      60 overweight subjects with a BMI of 25 to 29,9 kg/m2 are to be included. The safety of 900
      mg/1800 mg per day WS® 1442 is determined by adverse events, laboratory parameters, vital
      signs as well as by a treadmill test at the beginning and the end of the study. Endothelial
      function measured before and after two different training modalities is compared to that
      measured before and after intake of two different doses of WS® 1442.
    

Intervention name(s): WS® 1442 900 mg/d; WS® 1442 1800 mg/d; Nordic walking training 2 x 30 min/week; Nordic walking training 4x45 min/week
Intervention type(s): Drug; Drug; Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Keywords: (BMI 25-29,9 kg/m2)
Chronic Alcohol, Stress Inflammatory Response and Relapse Risk
Condition: Alcohol Dependence; Depressive Symptomatology
MeSH terms: Alcoholism
Study type: Interventional

Summary: 
      The purpose of this study is to examine potential stress and immune systems adaptations
      underlying craving and relapse vulnerability in alcohol dependent (AD) individuals and social
      drinkers (SDs) with and without high levels of depressive symptomatology (+dep / - dep).
      Using the investigators experimentally validated guided imagery procedure, the investigators
      propose to examine the response of brain stress and immune systems to personalized guided
      stressful imagery using subjective, physiological and neurobiological assessments in 60
      healthy controls and 60 alcoholic dependent individuals with and without depressive
      symptomatology.
    


Intervention name(s): Personal Stress Imagery; Neutral Imagery
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The stress imagery script will be based on participants' description of a recent personal event experienced as "most stressful", and determined as such by rating it above 8 on a 10-point stress scale. These may include breakup with a significant other or job-related stress. A 5-minute 'script' of each scenario will be written using Scene Construction Questionnaires where physiological, bodily sensations regarding the event will be obtained. Scripts will then be recorded onto audiotape for guided imagery in the laboratory sessions.; The neutral script will be developed from a personal non-alcohol-related relaxing situation. A 5-minute 'script' of each scenario will be written using Scene Construction Questionnaires where physiological, bodily sensations regarding the event will be obtained. Scripts will then be recorded onto audiotape for guided imagery in the laboratory sessions.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Alcohol dependence; Stress; Cytokines; Depressive Symptomatology
High Dose Therapy and Peripheral Blood Stem Cell Transplantation in HIV Related Non Hodgkin Lymphoma (NHL) at High Risk
Condition: HIV-related Lymphoma; HIV Infections
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin; Lymphoma, AIDS-Related
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to evaluate the efficacy of an intensified first-line treatment,
      with conventional chemotherapy (CHOP) plus monoclonal antibody anti CD20, followed by high
      dose chemotherapy and PBSC transplantation in HIV-related aggressive non-Hodgkin lymphoma at
      "high risk" , according to the international prognostic index (IPI).
    

Detailed description: 
      HIV associated NHL show particularly aggressive clinical features and a worse prognosis
      compared to the general population. The recent introduction of highly active antiretroviral
      therapy (HAART)has improved HIV positive patients' clinical conditions and reduced the risk
      of opportunistic infections, thus making HIV+ patients more similar to HIV- patients. Several
      studies have shown that the early use (as first line treatment) of high dose chemotherapy
      (HDT) with peripheral blood stem cell transplantation (PBSCT) is superior in the HIV negative
      setting to conventional dose chemotherapy, at least in patients with poor prognostic factors
      at diagnosis. Recently, several experiences have shown the feasibility, safety and efficacy
      of HDT and PBSCT, in association with HAART, as salvage therapy in HIV positive patients with
      lymphoma who maintain a chemosensitive disease after first-line treatment failure. It is
      rationale therefore to explore the use of this treatment strategy earlier, within the upfront
      treatment of HIV-associated lymphoma, in those patients with poor prognostic factors at
      diagnosis, according to the international prognostic score (IPI).
    

Intervention name(s): Rituximab and CHOP regimen + PBSCT
Intervention type(s): Other
Other intervention name(s): Mabthera; cyclophosphamide; adryamicin; vincristine; prednisone; BiCNU; etoposide; aracytin; melphalan
Intervention MeSH terms: Prednisone; Cyclophosphamide; Melphalan; Rituximab; Etoposide; Vincristine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HIV; non hodgkin lymphoma; peripheral blood stem cell transplantation
Is There Any Correlation Among Neonates Anthropometry and Neuromotor Behaviour
Condition: Cerebral Palsy, Autism or Other Neuromotor Behavior Abnormalities Correlation With Anthropometry
MeSH terms: Cerebral Palsy
Study type: Observational

Summary: 
      To explore the association among anthropometric parameters and neuromotor behaviour in
      neonates for early identification and prediction of later neuromotor deficit.
    

Detailed description: 
      The association between anthropometric (birth weight, length and occipitofrontal
      circumference) measurement and hands-on measurement of above mentioned anthropometric
      dimensions and demographic dimension (bilateral forearm, midarm, calf and thigh) with
      neuromotor behaviour were explored.
    

Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Both term and preterm neonates from level III B NICU
      
Keywords: Correlation; infants; muscles; weight; length
Hypochlorous Acid Disinfection Prior to Cataract Surgery
Condition: Cataract; Endophthalmitis
MeSH terms: Endophthalmitis; Cataract
Study type: Interventional
Phase: Phase 3

Summary: 
      Antibiotics are commonly utilized to reduce the bacterial population of the eye prior to
      surgery with the assumption that this reduces the risk of endophthalmitis, although it is not
      clear if this actually occurs. This study will investigate the use of Hypochlorous Acid, a
      commercially available over the counter (OTC) medication to see if this will reduce the
      bacterial population prior the cataract surgery.
    


Intervention name(s): Hypochlorous Acid Gel 0.02%
Intervention type(s): Drug
Intervention description(s): 0.02% Hypochlorous Acid Gel (OCusoft Hypochlor GEL) will be sprayed onto the closed eyelid of the surgical eye while covering the fellow eye with palm of the hand, left for 60 seconds, then wiped off with a clean gauze, tissue, or cotton ball.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Ocular/Eyelid Flora
Hypoxia at Multiple Wavelengths of Light
Condition: Hypoxia in Healthy Individuals
MeSH terms: Hypoxia
Study type: Observational

Summary: 
      The purpose of the study is to assess the effect of progressive, incremental hypoxia at
      multiple wavelengths of light.
    

Detailed description: 
      No additional information is required.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy volunteers
      
Keywords: Hypoxia; Multiple wavelengths