bioihbjkbjnl/mcl2 huggingface dataset:
Mechanisms of Hypoglycemia Associated Autonomic Dysfunction Question 2
Condition: Type 1 Diabetes
MeSH terms: Autonomic Nervous System Diseases; Primary Dysautonomias; Diabetes Mellitus, Type 1; Hypoglycemia
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this study is to determine the way by which Alprazolam (Xanax) an anti-anxiety
      drug affects specialized molecules in your brain called GABA (A) receptors that alter your
      body's ability to defend itself from low blood sugar (hypoglycemia). We hypothesize that
      prior activation of GABA (A) receptors may result in blunting of counterregulatory responses
      during subsequent hypoglycemia and exercise.
    

Detailed description: 
      The ultimate goal of this project is to identify treatments and approaches that will allow
      patients with diabetes to enjoy all the benefits of good glycemic control without the
      damaging limitations of severe hypoglycemia. The specific aim of this study is to determine
      if gamma aminobutyric acid (GABA A) receptors plays a role in the development of exercise
      associated autonomic dysfunction in type 1 diabetes and healthy man.
    

Intervention name(s): Alprazolam; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 1 mg given orally prior to morning and afternoon clamps on Day 1; 1 mg given orally prior to glucose clamps on Day 1 (morning and afternoon)
Other intervention name(s): Xanax
Intervention MeSH terms: Alprazolam
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Type 1 Diabetes; Alprazolam; Exercise
Robotic Surgical Management of Endometriosis: Excision Versus Ablation
Condition: Endometriosis
MeSH terms: Endometriosis
Study type: Interventional

Summary: 
      Patients who are planning to undergo laparoscopic surgery for endometriosis will be assigned
      to either ablation or excision of endometriosis. The investigators think that patients who
      have excision of endometriosis will have greater relief of pain.
    

Detailed description: 
      Patients with known endometriosis based on prior surgical pathology or suspected
      endometriosis based on symptomatology who plan on undergoing diagnostic laparoscopy will be
      offered enrollment in the study. They will complete preoperative pain assessments with the
      tools outlined above. At the time of diagnostic laparoscopy, patients found to have
      endometriosis will be staged according to the American Society of Reproductive Medicine
      guidelines. Patients with Stage 4 or deeply infiltrating endometriosis will be excluded from
      the study. At that point, the patients will be randomized in the operating room to either
      laparoscopic excision of endometriosis or laparoscopic ablation with the argon beam
      coagulator. Patients will be stratified according to the presence or absence of the
      Levonorgestrel-Intrauterine Device.

      Pain assessments will be performed immediately postoperatively in the recovery area. Pain
      assessments will again be performed at 4 weeks, 6 months and 12 months. We will use the VAS
      pain scale and validated questionnaires.
    

Intervention name(s): Robotic ablation; Robotic excision
Intervention type(s): Procedure; Procedure
Intervention description(s): Robotic laparoscopic ablation of endometriosis with the argon beam coagulator (ABC); Robotic excision of endometriosis
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Robotics; Laparoscopy; Endometriosis; Argon; Gynecology
A Study of LY3502970 in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purposes of this study are to determine:

        -  The safety of LY3502970 and any side effects that might be associated with it.

        -  How much LY3502970 gets into the bloodstream and how long it takes the body to get rid
           of it.

      This study has 5 parts (A, B, C, D, and E). Parts A and D involve a single dose of LY3502970
      and will last about 15 days. Part B and E involve multiple doses of LY3502970 and will last
      about 4 weeks. Part C involves two single doses of LY3502970 and will last about 29 days.
      Each participant will enroll in only one part. Screening must be completed within 28 days
      before study start. This study is for research purposes only, and is not intended to treat
      any medical condition.
    


Intervention name(s): LY3502970; Placebo; Atorvastatin; Simvastatin; Midazolam
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Administered orally.; Administered orally.; Administered orally.; Administered orally.; Administered orally.
Intervention MeSH terms: Midazolam; Atorvastatin; Simvastatin
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Part C is a crossover design.
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Prepare - How to Reach Women of Reproductive Age With Obesity to Support Weight Loss Before Pregnancy?
Condition: Obesity; Pregnancy Complications
MeSH terms: Pregnancy Complications; Obesity; Weight Loss
Study type: Observational

Summary: 
      Researchers at Harvard Pilgrim Health Care Institute and Massachusetts General Hospital are
      conducting a study to learn more about how best to reach out to women (age 18-45) who are
      thinking about a pregnancy in the next couple of years and currently have a BMI greater than
      30 kg/m2.

      Interested participants will be asked to complete a 15-minute survey. The survey will ask
      some more questions about their prior reproductive health history, opinions and experiences
      regarding lifestyle, weight and health. After completing the survey, researchers would like
      to arrange a time to complete a 20- to 30-minute semi-structured interview about their
      perceived health in the process of planning pregnancy.
    

Detailed description: 
      The purpose of this study is to learn the best ways to support healthful behaviors and weight
      loss prior to pregnancy. Researchers are also interested in what motivates or prevents women
      of reproductive age from engaging in a structured weight loss program. Participants will be
      asked for no more than an hour of their time to complete a brief survey and participate in an
      interview. This study is being conducted by Harvard Pilgrim Health Care Institute. This study
      is being paid for by the Nutrition Obesity Research Center at Harvard (NORCH).

      At the end of the interview, study staff will also talk to participants about the opportunity
      to be referred to the Mass General Weight Center if they are interested in participating in a
      program now being offered there.

      If participants elect to participate in a program at the weight center, researchers would
      then like to complete 2 more short interviews with these participants about that process. The
      first will be about 5 minutes and will take place just after the initial Weight Center
      Orientation, and the last will be about 10 minutes and take place after 3 months of
      participation. During this final interview, researchers will ask for participant opinions
      about the program that they have just participated in.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants will include patients in Massachusetts General Hospital clinical settings,
        users of the Ovia fertility app as well as members of the community who may see ads posted
        in local newspapers.
Incidence, Risk Factors, Predictors and Survival for Neurological Complications After Liver Transplantation
Condition: Liver Transplant; Complications; Neurologic Complication; Postoperative Complications
MeSH terms: Postoperative Complications
Study type: Observational

Summary: 
      Liver transplantation is the definitive treatment in patients with chronic liver disease.
      Neurological complications (NC) occur commonly after liver transplantation. The investigators
      aim to evaluate the incidence, risk factors and predictors of neurological complications in
      both living donor and deceased donor transplantation done in the hospital. Between January
      2011 to December 2016, 253 liver transplant recipients were recruited for this study. The
      investigators recorded the incidence of neurological complications, their median time of
      onset, their relationship with etiology of chronic liver disease, and the risk factors for
      the complications. The investigators also studied the relationship of neurological
      complications with duration of hospital and ICU stay, and survival. Using multivariate
      forward regression analysis , the investigators developed a scoring system for prediction of
      neurological complications in liver transplantation.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        All patients who underwent liver transplant surgery for the specified time period were
        included in the study.
      
Keywords: liver transplantation; neurological complications; postoperative complications
Effectiveness of Modafinil for Treating Fatigue in Adults With HIV/AIDS
Condition: HIV Infections; Fatigue
MeSH terms: Fatigue
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will determine whether modafinil (Provigil®), a medication approved for the
      treatment of narcolepsy, is effective in reducing fatigue in adults with HIV/AIDS.
    

Detailed description: 
      Fatigue is a common problem for many people with HIV/AIDS, interfering with daily activities
      and serving as a significant barrier to working among those whose health is otherwise stable
      or restored by antiretroviral (ARV) medication. Fatigue in HIV is associated with disability
      and diminished quality of life. It may be caused by ARVs or by the virus itself. This study
      will determine if modafinil can reduce fatigue in HIV/AIDS patients.

      This study will last 12 weeks. Participants will be randomly assigned to receive either
      modafinil or placebo daily for 4 weeks. Participants who show an improvement in symptoms will
      receive modafinil for an additional 8 weeks. Participants who do not respond to modafinil
      will have the opportunity to receive other drug treatments. All participants will have weekly
      study visits for the first 4 weeks of the study and biweekly visits for the remainder of the
      study. At each visit, participants will complete various tasks to determine cognitive
      function and self-report scales will be used to determine symptoms of depression and fatigue.
    

Intervention name(s): Modafinil; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 50 mg per day, increasing to 200 mg per day as clinically indicated; 50 mg per day, increasing to 200 mg per day as clinically indicated
Other intervention name(s): Provigil; sugar pill
Intervention MeSH terms: Modafinil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: HIV; AIDS; Modafinil; Depression
A Study of RO5093151 in Patients With Non-Alcoholic Fatty Liver Disease
Condition: Fatty Liver, Non-alcoholic Fatty Liver Disease, NAFLD
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This multi-center, double-blind, randomized, placebo-controlled study will evaluate the
      change in liver fat content, pharmacokinetics and safety of RO5093151 in patients with
      non-alcoholic fatty liver disease. Patients will be randomized to receive either daily oral
      doses of RO5093151 or matching placebo. The anticipated time on study treatment is 12 weeks.
    


Intervention name(s): Placebo; RO5093151
Intervention type(s): Drug; Drug
Intervention description(s): Oral daily doses for 12 weeks; Oral daily doses for 12 weeks
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Virtual Anatomical Reconstruction of Mandibular Bone Defects Using a Statistical Shape Model
Condition: Mandibular Diseases; SSM
MeSH terms: Mandibular Diseases
Study type: Observational

Summary: 
      Hundred already taken CT-scans (50 male and 50 female) will be anonymized. These scans will
      be segmented and implemented into a statistical shape model that will be used to predict
      missing hard tissue of a mandible based on the remaining bone.
    

Detailed description: 
      Together with the radiology and Craniomaxillofacial (CMF) department, 100 scans will be
      selected from the database (50 males and 50 females, between 20 and 60 years old). First,
      they will be anonymized (except the sex and age/date of birth). Afterwards, they will be
      segmented using Materialise Mimics software. The segmented mandibles will then be used to
      create a statistical shape model (SSM) using principal component analysis. This model will
      afterwards be used to predict the mandibular shapes.
    

Intervention name(s): CT-scan evaluation and segmentation
Intervention type(s): Other
Intervention description(s): CT-scans will be evaluated (to see if they are included in the research group) and segmented if they are accepted.
Observational model: Ecologic or Community
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        European adults
Phase I Safety and Immunogenicity of FP-02.2 in Chronic Hepatitis B
Condition: Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      This study evaluates the safety and immunogenicity of FP-02.2, a new therapeutic Hepatitis B
      vaccine, administered as an add-on therapy to entecavir or tenofovir.
    

Detailed description: 
      This study evaluates the safety and immunogenicity of FP-02.2, a new therapeutic Hepatitis B
      vaccine, administered as an add-on therapy to entecavir or tenofovir. HBeAg-negative subjects
      will be randomized to receive low or high dose vaccine, in the presence or absence of IC31®
      adjuvant, or to receive placebo or IC31® adjuvant alone.
    

Intervention name(s): FP-02.2 Vaccine; Placebo; IC31® Adjuvant
Intervention type(s): Biological; Other; Other
Intervention description(s): Synthetic Peptide Hepatitis B Vaccine; Placebo; IC31® Adjuvant
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study on Continuous Intravenous of Unfractionated Heparin (UFH) to Treat Progressive Cerebral Infarction
Condition: Heparin Causing Adverse Effects in Therapeutic Use; Heparin-induced Thrombosis; Acute Cerebral Ischemia
MeSH terms: Cerebral Infarction; Brain Ischemia; Thrombosis; Infarction; Ischemia
Study type: Observational

Summary: 
      A clinical trial to study the effects of dosage, infusion methods and complications of
      unfractionated heparin (UFH) treating acute progressive cerebral infraction was conducted. In
      this study, we observed the effects of four UFH treatments on 480 acute progressive cerebral
      infraction patients during from the 6th and the 72nd hour after the attack. It was concluded
      that the ultra-slow continuous intravenous infusion of UFH can significantly reduce the
      neurological deficit score of patients with progressive cerebral infarction, increase the
      cure rate, decrease the recurrence rate, and improve long-term quality of daily life. It is
      more effective than the treatment of intravenous infusion of low- molecular- weight UFH at
      once a day, and the risk of bleeding may not necessarily be increased.
    

Detailed description: 
      Treatment' effectiveness rates of the four groups were 95.80%, 85.22%, 85.47%, and 87.72%
      respectively. The result of Group A was significantly different from those of Group B, C, and
      D (p <0.05). The adverse complication occurrence rates of the four groups were 5.88%, 3.48%,
      4.27% and 3.51%.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        From May 2003 to October 2009 480 patients of acute progressive cerebral infraction that
        matched the standards above were included in the research.
      
Biospecimen description: 
      serum
Radiolabeled Study of CC-122 in Healthy Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the metabolism and excretion of [14C]-CC-122 in healthy male subjects
    

Detailed description: 
      This is a single-center, open-label study to evaluate the metabolism and excretion of
      [14C]-CC-122 following a single oral dose of [14C]-CC-122 in healthy male subjects. It is
      planned for 6 subjects to be enrolled; each subject will participate in a screening phase, a
      baseline phase, a treatment phase, and a follow up phone call. Blood, urine and fecal samples
      will be collected for analyses.
    

Intervention name(s): CC-122
Intervention type(s): Drug
Intervention description(s): 3mg [14C]-CC-122 will be administered as a single dose
Intervention model: Single Group Assignment
Primary purpose: Other
Keywords: Pharmacokinetics, Healthy Subjects
Open Label, Dose Escalation Phase I Study of AZD2281
Condition: Advanced Solid Malignancies
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to assess the safety and tolerability of AZD2281 following single
      and multiple oral doses in patients in Japan with advanced solid malignancies
    


Intervention name(s): KU-0059436 (AZD2281)(PARP inhibitor)
Intervention type(s): Drug
Intervention description(s): oral
Other intervention name(s): Olaparib
Intervention MeSH terms: Olaparib; Poly(ADP-ribose) Polymerase Inhibitors
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cancer; Advanced solid malignancies
Safety and Tolerability Study of KNS-760704 in Amyotrophic Lateral Sclerosis (ALS)
Condition: Amyotrophic Lateral Sclerosis
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This was a 2-part study of dexpramipexole in patients with ALS.

      Part 1 was a randomized, placebo-controlled, multi-center study to evaluate the safety,
      tolerability, and clinical effects of oral administration of 3 dosage levels of
      dexpramipexole vs. placebo for 12 weeks.

      Part 2 was a randomized, double-blind, 2-arm, parallel group, extension study evaluating the
      safety, tolerability, and clinical effects of oral administration of 2 dosage levels of
      dexpramipexole for up to 72 weeks.
    

Detailed description: 
      This study was a two-part, multicenter, double-blind study in subjects with ALS to evaluate
      the safety and tolerability of dexpramipexole treatment, as well as the preliminary effects
      on measures of clinical function and mortality of dexpramipexole treatment.

      In part 1, 102 subjects with ALS were randomized at 20 US sites to receive placebo,
      dexpramipexole at 50 mg/day; dexpramipexole at 150 mg/day; or dexpramipexole at 300 mg/day
      for 12 weeks. Participants who completed Part 1 were eligible to enroll into Part 2.

      Part 2 was a randomized, double-blind, 2-arm, parallel-group, extension study evaluating the
      longer-term safety, tolerability, and clinical effects of oral administration of 2 dosage
      levels of dexpramipexole. In part 2, following a 4-week, placebo washout, continuing subjects
      received dexpramipexole at 50 mg/day or 300 mg/day as double-blind treatment for up to 72
      additional weeks (Part 2 duration was up to a total of 76 weeks, including the 4 week placebo
      portion).
    

Intervention name(s): Placebo; Dexpramipexole 50 mg/day; Dexpramipexole 150 mg/day; Dexpramipexole 300 mg/day
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Placebo: 2 tablets taken orally twice daily; Dexpramipexole: 2 x 12.5 mg tablets taken orally twice daily; Dexpramipexole: 2 x 37.5 mg tablets taken orally twice daily; Dexpramipexole: 2 x 75 mg tablets taken orally twice daily
Other intervention name(s): KNS-760704; BIIB050; KNS-760704; BIIB050; KNS-760704; BIIB050
Intervention MeSH terms: Pramipexole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ALS; Amyotrophic Lateral Sclerosis; Lou Gehrig; Lou Gehrig's; Lou Gehrig's disease; Motor Neuron Disease; Nervous System Diseases; KNS-760704; BIIB050
Tolerability and Pharmacokinetics/-Dynamics of Single Rising Doses BIBT 986 BS in Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to assess the tolerability of BIBT 986 BS after intravenous infusions of 0.1, 0.3, 1.0,
      2.5, 5.0, and 10 mg, to assess the pharmacokinetics of BIBT 986 BS after intravenous infusion
      and to assess the effect of BIBT 986 BS on blood coagulation parameters
    


Intervention name(s): BIBT 986 BS - single rising dose; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment