bioihbjkbjnl/mcl2 huggingface dataset:
Pilot Study: A Telehealth Intervention for Caregivers of Infants With Early Signs of Autism Spectrum Disorder
Condition: Autism Spectrum Disorder; Developmental Delay
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Study type: Interventional

Summary: 
      Caregiver coaching will be provided using telehealth technology, in order to determine the
      efficacy and effectiveness of the telehealth medium of intervention delivery for caregivers
      of infants with concern for ASD.
    

Detailed description: 
      Ideally, all caregivers with an infant identified with concern for ASD would have immediate
      access to good quality caregiver coaching provided in the most natural environment possible.
      However, this is currently not the case for the majority of families. There are no
      empirically validated treatment programs for infants showing ASD risk. The proposed research
      project will use Applied Behavior Analysis-based single-subject experimental designs to
      further develop a promising caregiver-mediated intervention designed for infants showing
      early signs of ASD. Caregiver coaching will be provided using telehealth technology, in order
      to maximize recruitment opportunities and to determine the efficacy and effectiveness of the
      telehealth medium of intervention delivery for caregivers of infants with concern for ASD.
    

Intervention name(s): infant telehelp
Intervention type(s): Behavioral
Intervention description(s): Adapted from Early Start Denver Model (ESDM), a naturalistic developmental behavioral intervention
Intervention model: Sequential Assignment
Intervention model description: single subject multiple baseline design
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of the Efficacy of Novel Ibuprofen Acetaminophen Combination Formulations in the Treatment of Post-surgical Dental Pain
Condition: Pain
MeSH terms: Toothache
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will determine the overall analgesic efficacy of three different fixed dose
      ibuprofen plus acetaminophen formulations compared to ibuprofen alone and to placebo.
    


Intervention name(s): Ibuprofen/acetaminophen; Ibuprofen/acetaminophen; Ibuprofen/acetaminophen; Ibuprofen; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Two caplets of ibuprofen 100 mg plus acetaminophen 250 mg; Two caplets of ibuprofen 125 mg plus acetaminophen 250 mg; Two caplets of ibuprofen 150 mg plus acetaminophen 250 mg; Two caplets of ibuprofen 200 mg; Two caplets of placebo
Intervention MeSH terms: Acetaminophen; Ibuprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: ibuprofen; acetaminophen; pain; molar extraction
Short Term Effect of Smoking Cessation on Human Metabolism
Condition: Smoking Cessation; Metabolic Syndrome
MeSH terms: Metabolic Syndrome
Study type: Observational

Summary: 
      Investigating the short term smoking cessation on metabolism, examining of participant of
      smoking cessation workshops and former participants' file survey for metabolic aspects
    

Detailed description: 
      Objective: To examine metabolic aspects occurring during the first 6-12 months following
      smoking cessation in participants of smoking cessation workshops.

      Design: A two armed study: prospective and retrospective. Prospective: Weight, BMI, waist
      circumference and waist: hip ratio were measured before, during and 6 months post cessation
      program. Retrospective: Blood test data for Blood fasting glucose (BFG) and lipid profile
      from the year preceding the workshops and the year after them were analyzed from
      participants' files. Smoking status was verified by phone conversation.
    

Intervention name(s): Smoking cessation workshops
Intervention type(s): Behavioral
Intervention description(s): All the participants took part in smoking cessation workshops. The comparison of metabolic aspects was made between the smokers and non-smokers
Observational model: Case-Control
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Volunteers who were recruited from the smoking cessation workshops of the Meuhedet HMO
        (Israeli Health Services) during 2016-2017.
Randomized Control Trial Copper Intrauterine Device and Depo-medroxyprogesterone Acetate (DMPA) of HIV+ Women in Malawi
Condition: HIV
Study type: Interventional

Summary: 
      The IUD is an extremely effective method of contraception yet few women use it worldwide.
      Considered safe to use in HIV+ women, few studies have evaluated its use among those using
      antiretroviral therapy. The only prior randomized trial looking at the IUD compared to
      hormonal contraception noted a high rate of IUD discontinuations. Understanding IUD
      acceptability and continuation is critical to improve utilization.

        -  Objective 1: Determine WHO medical eligibility and the willingness for IUD placement

        -  Objective 2: Compare method-related side effects and adverse events

        -  Objective 3: Assess the 1-year acceptability and continuation rates

      Methods: To address our objectives the investigators have designed a two Phase Study:

        -  A cross-sectional screening to evaluate contraceptive medical eligibility and
           desirability

        -  A randomized controlled trial that will compare acceptability and adherence to DMPA
           compared to the Copper IUD: enrolling 200 women stable on antiretroviral therapy to
           follow for 1 year
    


Intervention name(s): Copper IUD; Depo Medroxyprogesterone acetate
Intervention type(s): Drug; Drug
Intervention description(s): Copper IUD (CuT360); DMPA 150 mg IM q 3 months
Other intervention name(s): DMPA; Depo Provera
Intervention MeSH terms: Copper; Medroxyprogesterone Acetate; Medroxyprogesterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Acceptability and Adherence to methods
Thoracolumbar Brace for Individuals With Parkinson's Disease
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      This pilot study looked to see if a new brace would change the way people with Parkinson's
      Disease positioned their bodies. It also gathered information on the experience of wearing
      the brace.
    


Intervention name(s): Calibrace
Intervention type(s): Device
Intervention description(s): The CALIBRACE is a new product designed to improve posture using a front-to-back tensioning system that lifts shoulders up and back.
Intervention model: Single Group Assignment
Intervention model description: Single-subject A-B design
Masking: None (Open Label)
Primary purpose: Device Feasibility
Tailored Treatment to Enhance Risk Perception in Sleep Apnea
Condition: Obstructive Sleep Apnea (OSA)
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      Obstructive Sleep Apnea (OSA) is seen in approximately 6% of Americans. It is a serious
      medical condition with significant medical and psychological consequences, including
      diabetes, hypertension, and cardiovascular disease. The treatment of choice for OSA is
      Positive Airway Pressure therapy (PAP). PAP supplies positive pressure to the upper airway
      creating a "pneumatic splint" to keep the airway open during sleep. Adherence to PAP is
      notoriously low, with as few as 50% reaching minimal guidelines for adherence. One
      comprehensive review of adherence research found that adherence to PAP was less than that for
      any other medical disorder. The problem of adherence is significant not only because of the
      medical consequences that can ensue, but also because third party payers have begun to refuse
      to pay for PAP therapy when adherence is less than optimal, even in the face of clinical
      improvement. This is a critical time to address this problem.

      This research study is designed to identify methods that may help people respond to PAP, the
      most common therapy for OSA. Identifying these methods may be an important way to better care
      for patients with obstructive sleep apnea. With this research, the investigators hope to find
      ways to help people have a better response to treatment and a better quality of life.
    


Intervention name(s): Brief Personalized Video (BPV); Non-Personalized Video (NPV); Treatment as Usual (TAU)
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): The BPV group will view a portion of their own sleep study that took place during their overnight sleep study.; The NPV group will see a stock video of someone with OSA.; The TAU group will not watch a video.
Other intervention name(s): BPV; NPV; Standard of Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Study Evaluating Enbrel Drug Levels in Healthy Male Chinese Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the Pharmacokinetics (PK) and safety and
      tolerability of etanercept, 25 and 50 mg, administered as a single dose to healthy male
      Chinese subjects.
    


Intervention name(s): Etanercept
Intervention type(s): Drug
Intervention MeSH terms: Etanercept
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Study to Determine the Pharmacodynamics of LX4211 Relative to Meals in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to evaluate the pharmacodynamics of LX4211 relative to
      meals in healthy subjects.
    


Intervention name(s): Schedule A; Schedule B; Schedule C; Schedule D; Schedule E
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Dosing 1 hour before breakfast; Dosing 0.5 hour before breakfast; Dosing immediately before breakfast; Dosing immediately before lunch; Split dose, dosing 1 hour before breakfast and dinner
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pharmacodynamics
Immunostimulating Interstitial Laser Thermotherapy in Pancreatic Cancer
Condition: Neoplasms Pancreatic
Study type: Interventional

Summary: 
      Thermotherapy is a technology aiming at destroying tissue, for example tumor tissue.
      Immunostimulating Interstitial Laser Thermotherapy (imILT) is a specific form of
      thermotherapy, which, in addition to destroying tumor tissue, has been optimized to cause a
      tumor specific immunologic response. In laboratory animals the imILT method has also been
      shown to induce a so called abscopal effect. This means that when one tumor is treated with
      imILT other, untreated, tumors also decrease in size.

      The purpose of this trial is to evaluate efficiency when it comes to local tumor destruction
      of the imILT treatment method in patients diagnosed with pancreatic cancer. The purpose is
      also to investigate the functionality and safety as well as understanding of the subsequent
      immunological effects.

      This trial is prospective, open and non-randomized. Five patients diagnosed with pancreatic
      cancer will be treated in this trial, which is estimated to be carried out during a time
      period of 36 months.
    


Intervention name(s): Immunostimulating Interstitial Laser Thermotherapy
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hyperthermia, Induced; Laser Coagulation; Laser Therapy
Apoe Impact Study on Brain Structure and Function, in a Population 45 to 75 Years Old
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Observational

Summary: 
      The purpose of this study is to investigate the influence of the APOE genotype on brain
      morphology, function and metabolism, related to other factors such as cognitive reserve,
      cognition and episodic memory, in subjects at greater risk of developing AD.
    

Detailed description: 
      The purpose of this study is to investigate the influence of age and the APOE genotype on
      brain morphology and function, in 700 cognitively healthy individuals, 45 to 75 years old,
      recruited from an ongoing longitudinal cognition study exploring memory and executive
      functions (ClinicalTrials.gov ID: NCT01835717).

      All subjects have been APOE genotyped and underwent a clinical and cognitive assessment.
      Within this study, the subjects will be submitted to an MRI scanning protocol including
      morphological and resting state acquisitions. An identical follow-up MRI session will be
      performed in 2 years' time. The analyses will be focused on detecting the effect of the APOE
      allelic variants on the change rate of the neuroimaging variables as well as its interaction
      with aging.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The population of this study is 45 to 75 years old at the time of inclusion in the parent
        study (ClinicalTrials.gov ID: NCT01835717), mostly sons and daughters of AD patients.
      
Keywords: Alzheimer's, MRI, APOE
Research on the Nature, Diagnosis, and Treatment of Obesity and Diabetes
Condition: Insulin Resistance; Obesity
MeSH terms: Obesity; Insulin Resistance
Study type: Observational

Summary: 
      The purpose of this study is to determine whether the level of FOXA2 expression in fat tissue
      is a biomarker of insulin resistance. To test this hypothesis, we will perform
      euglycemic-hyperinsulinemic clamps in normal and obese human subjects to calculate insulin
      sensitivity, and see if insulin sensitivity correlates with the FOXA2 expression in
      subcutaneous fat.
    

Detailed description: 
      The investigators at Rockefeller University Hospital are engaged in research on the nature,
      diagnosis and treatment of obesity and diabetes. The investigators are trying to find out why
      insulin, a blood sugar lowering hormone that is released by the pancreas following a meal,
      does not work effectively in individuals with obesity or type 2 diabetes. The investigators
      have recently discovered a protein in fat cells of obese mice that helps fat cells to take up
      and break down sugar from the blood. This protein (called FOXA2) also prevents the generation
      of more fat cells. FOXA2 is only present in obese mice, but absent from fat stores of lean
      animals. Insulin can stimulate the production of FOXA2 in fat cells. Furthermore, the levels
      of FOXA2 protein correlate with the degree of blood insulin levels. In this study, we are
      would like to determine whether FOXA2 is also produced in fat cells of humans, and if its
      level correlates with the degree of obesity and insulin resistance.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy volunteers of different BMI classifications
      
Keywords: Healthy Volunteers
A Study to Evaluate Ertapenem Versus It's Comparator in the Treatment of Complicated Intra-abdominal Infections in Adults (0826-050)(COMPLETED)
Condition: Complicated Intra-abdominal Infection
MeSH terms: Infections; Communicable Diseases; Intraabdominal Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      This was a prospective, randomized, controlled, open, and multi-center trial conducted to
      compare the clinical efficacy and safety of ertapenem with it's comparator before or
      following adequate surgical management of complicated intra-abdominal infection.
    


Intervention name(s): MK0826; ertapenem sodium; Comparator: ceftriaxone + metronidazole
Intervention type(s): Drug; Drug
Intervention MeSH terms: Metronidazole; Ceftriaxone; Ertapenem
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Compression Device Safety Study on Edema
Condition: Edema
MeSH terms: Edema
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the safety of the prototype Compression Device in subjects with Oedema
    


Intervention name(s): Prototype device (unnamed) worn-no pressure given (placebo) from inflatable cuffs; Prototype device(unnamed)-A battery operated inflatable pneumatic cuffs; Prototype device(unnamed)-A battery operated inflatable pneumatic cuffs; Prototype device(unnamed)-A battery operated inflatable pneumatic cuffs; Prototype device(unnamed)-A battery operated inflatable pneumatic cuffs; Prototype device(unnamed)-A battery operated inflatable pneumatic cuffs; Prototype device(unnamed)-A battery operated inflatable pneumatic cuffs
Intervention type(s): Device; Device; Device; Device; Device; Device; Device
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Enhancing Graft vs Leukemia Via Delayed Ex-Vivo Co-Stimulated DLI After Non-Myeloablative Stem Cell Transplantation
Condition: Acute Myelogenous Leukemia; Acute Lymphoblastic Leukemia; Myelodysplastic Syndrome
MeSH terms: Leukemia; Preleukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Myelodysplastic Syndromes
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a new platform in non-myeloablative allogeneic stem cell transplantation to improve
      survival by harnessing the immunologic potential of donor T-cells to induce and maintain
      long-term remissions in patients with hematologic malignancies without undue toxicity. This
      study involves is the first study in humans directed at optimizing the graft vs leukemia
      effect by infusing activated T-cells from healthy donors prophylactically, months after
      recovery from the initial transplant. Investigators are studying whether the activation of
      donor cells prior to infusion will enhance the patient's ability to "seek and destroy"
      residual malignant cells while also helping the immune system to fight infection without
      increasing the immune reaction against the host.
    


Intervention name(s): Non-myeloablative allogeneic stem cell transplant with prophylactic activated DLI; "Prophylactic" delayed ADLI; "Prophylactic" delayed activated donor lymphocyte infusion
Intervention type(s): Drug; Drug; Drug
Intervention description(s): "Prophylactic" delayed activated donor lymphocyte infusion (ADLI) after non-myeloablative conditioning and allogeneic peripheral blood cell stem cell transplantation; "Prophylactic" ADLI after non-myeloablative conditioning and allogeneic peripheral blood cell stem cell transplantation; "Prophylactic" delayed activated donor lymphocyte infusion (ADLI) after non-myeloablative conditioning and allogeneic peripheral blood cell stem cell transplantation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: AML; ALL; MDS; Allogeneic transplant; Acute Myelogenous Leukemia; Acute Lymphoblastic Leukemia; Myelodysplastic Syndrome; Adoptive cell therapy; Non-myeloablative
Dose-Ranging Study Of GSK233705B In Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of GSK233705B compared with
      placebo in subjects with COPD.
    


Intervention name(s): GSK233705 12.5mcg; GSK233705 25mcg; GSK233705 50mcg; GSK233705 100mcg; GSK233705 200mcg; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Once daily via dry powder inhaler; once daily via dry powder inhaler; Once daily via dry powder inhaler; Once daily via dry powder inhaler; Once daily via dry powder inhaler; Once daily via dry powder imhaler
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: COPD; Multicenter; GSK233705B; double-blind; Chronic Obstructive Pulmonary Disease (COPD); randomized
Effects of Nutritional Products on Blood Glucose in Subjects With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate average daily blood glucose in subjects with type 2 diabetes following a Meal
      Plan including Diabetes-Specific products compared to average daily blood glucose in subjects
      following their usual diet.
    


Intervention name(s): Nutritional Formula; Usual diet; Diabetes Meal Plan with experimental diabetes-specific nutritional shake, diabetes specific cereal, and diabetes specific snack bars.
Intervention type(s): Other; Other; Other
Intervention description(s): nutritional shake daily; usual dietary habits; nutritional shake, diabetes specific cereal and diabetes snack bar daily
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Determine the Efficacy of ZPL-3893787 in Subjects With Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 2

Summary: 
      This was a randomized, double blind, placebo controlled, parallel group study in
      approximately 90 subjects with moderate-severe AD Eczema Area and Severity Index (EASI) ≥12
      and ≤ 48 (0-72 scale). Following a run-in subjects were randomized to receive either oral 30
      mg ZPL-3893787 once daily (od) or placebo od for 8 weeks (56 days).
    


Intervention name(s): ZPL-3893787; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): ZPL-3893787; Matched Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Drug-drug Interaction of SP2086 and Metformin
Condition: Type 2 Diabetes
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open single and self-control study,planning to recruit 24 cases of healthy male
      volunteers.In the study,subjects were given SP2086 and metformin,and collects blood samples
      before and after medcine.The purpose is to evaluate the drug interaction between SP2086 and
      Metformin.
    


Intervention name(s): SP2086; Metformin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Metformin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment