bioihbjkbjnl/mcl2 huggingface dataset:
Prevention of Sagopilone-induced Neurotoxicity With Acetyl-L-Carnitine (ALC)
Condition: Prostate Cancer; Ovarian Cancer
Study type: Interventional
Phase: Phase 2

Summary: 
      This study investigates the safety and efficacy of Acetyl-L-Carnitine and compares it to the
      safety and efficacy of a placebo (inactive) tablet in the prevention of Sagopilone-induced
      peripheral neuropathy. Patients will receive intravenous infusion of sagopilone for 3 hours
      on day 1 of a 3-weeks cycle. Treatment with Sagopilone will be given as long as the patient
      is benefitting. In addition patients will receive ALC or placebo, starting 1 week before
      first sagopilone infusion and ending 30-33 days after the last infusion with sagopilone.
      Safety will be determined by laboratory and other evaluations. Efficacy of ALC will be
      determined by the incidence of all grades of peripheral neuropathy with the results of a
      patient questionnaire. Efficacy of the combination of ALC and Sagopilone will be determined
      by the tumor response.
    


Intervention name(s): Sagopilone 16 mg/m^2 i.v., Acetyl-L-Carnitine (ALC) 1000 mg tid, HRPC only: Prednisone or Prednisolone 5 mg bid; Sagopilone 16 mg/m^2 i.v. and placebo 1000 mg tid, HRPC only: Prednisone or Prednisolone 5 mg bid
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will receive intravenous (i.v.) infusion of Sagopilone for 3 hours on day 1 of a 3-weeks cycle. In addition, subjects will receive Acetyl-L-Carnitine (ALC) 1000 mg tid. Treatment with Sagopilone and ALC will be continued as long as there is benefit. Subjects with HRPC will also receive Prednisone or Prednisolone 5 mg bid, throughout the treatment with Sagopilone.; Subjects will receive intravenous (i.v.) infusion of Sagopilone for 3 hours on day 1 of a 3-weeks cycle. Treatment will be continued as long as there is benefit. In addition, subjects will receive 21 weeks of placebo 1000 mg tid. After all patients have completed 6 cycles of treatment, an analysis will be performed to see whether ALC was better than placebo. If this is the case, patients still under placebo treatment will be offered to switch to ALC. Subjects with HRPC will also receive Prednisone or Prednisolone 5 mg bid, throughout the treatment with Sagopilone.
Intervention MeSH terms: Acetylcarnitine; Prednisone; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Sagopilone; Epothilones; Prednisolone hemisuccinate; Prednisolone phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Peripheral Neuropathy; Prostate Carcinoma; Ovarian Carcinoma
A Study of Eszopiclone Co-administered With Venlafaxine in Subjects With Major Depressive Disorder and Insomnia
Condition: Major Depressive Disorder; Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders; Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the antidepressant effect of adjunctive treatment with Eszopiclone in subjects
      receiving venlafaxine for the treatment of Major Depressive Disorder (MDD).
    

Detailed description: 
      This is a double-blind, randomized, placebo-controlled, parallel-group study. The study
      consists of two groups of subjects with Major Depressive Disorder randomized to treatment
      with either eszopiclone 3 mg or placebo nightly at bedtime for 31 weeks beginning the night
      of Visit 2. In addition, all subjects will receive open-label treatment with venlafaxine.
      Safety and efficacy will be evaluated using clinical observations as well as physician and
      subject administered ratings scales. This study was previously posted by Sepracor Inc. In
      October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010,
      Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.
    

Intervention name(s): Eszopiclone; Placebo; Venlafaxine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Eszopiclone 3 mg; Placebo; Venlafaxine 75 mcg Weeks 1, 2, 29, and 30 Venlafaxine 150 mcg Weeks 3 through 28
Other intervention name(s): Lunesta; Effexor
Intervention MeSH terms: Eszopiclone; Venlafaxine Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Insomnia; Depression; Major Depressive Disorder
Volumes of Administration for Intranasal Midazolam
Condition: Children Requiring Sedation to Facilitate Laceration Repair
MeSH terms: Lacerations
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine exactly how much drug volume should be administered
      into each nare, so that the drug absorption can be maximized and the amount that runs out of
      the nose, or is swallowed, is minimized, thereby optimizing the effectiveness of any drug
      given intranasally. The investigators will determine this ideal "volume of administration" by
      studying intranasal midazolam in children who require sedation to facilitate laceration
      repairs. The investigators will evaluate both clinical outcomes as well as pharmacokinetic
      outcomes associated with each volume of administration. We will block randomize children to
      receive intranasal midazolam in maximum aliquots of one of the three following VOA: 200
      microliters (mcL), 500 mcL, or 1000 mcL.
    

Detailed description: 
      The intranasal route is an effective means of administering sedative medications for
      children. However, sometimes the child has to receive a certain dose that requires a very
      large volume to be administered into the nose, because of the types of concentrations of
      drugs that are available. Most drugs are not concentrated enough so that small volumes can be
      consistently given, so as a result, sometimes a very large amount of medication is
      administered intranasally. When the amount is too large, most of the medication either runs
      back out the nose, or down the back of the nose and throat and is swallowed, instead of being
      absorbed in the nasal cavity, where it can be quickly absorbed and produce optimal
      effectiveness.
    

Intervention name(s): Intranasal midazolam
Intervention type(s): Drug
Intervention description(s): Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD).
Other intervention name(s): No other name
Intervention MeSH terms: Midazolam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Sedation; Laceration repair; Children; Intranasal; Midazolam
Bioequivalence Study of Torrent Pharmaceuticals's Ltd's Nebivolol 20 mg Tablet
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      Subjects to compare the single dose bioavailability of Torrent's Nebivolol Tablets 20 mg and
      Bystolic 20 mg Tablets of Forest Pharmaceuticals Inc., USA. Dosing periods of studies were
      separated by a washout period of 11 days.
    

Detailed description: 
      An Open Label, Randomized, 2 -period, 2 -Treatment, 2 Sequence, Crossover, Single-dose
      Bioequivalence Study of Nebivolol Tablets containing Nebivolol 20 mg (Test Formulation,
      Torrent Pharmaceutical Ltd., India) Versus Bystolic® 20 mg Tablets containing Nebivolol 20 mg
      (Reference, Forest Pharmaceuticals Inc., USA) in Healthy Human Volunteers Under Fasting
      Condition.
    

Intervention name(s): Torrent's Nebivolol Tablets; Forest Pharmaceuticals Inc's Bystolic Tablets
Intervention type(s): Drug; Drug
Intervention MeSH terms: Nebivolol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Iron Supplements on the Pharmacokinetics of MT-6548
Condition: Healthy
Study type: Interventional
Phase: Phase 3

Summary: 
      The objectives of this study are to investigate the pharmacokinetics and safety of MT-6548
      co-administered with iron supplements in healthy male volunteers.
    


Intervention name(s): MT-6548; Iron supplement A; Iron supplement B; Iron supplement C; Iron supplement D
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Oral tablet; Oral tablet; Oral tablet; Oral tablet; Oral tablet
Other intervention name(s): vadadustat; AKB-6548
Intervention MeSH terms: Iron
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
A Study of LY2541546 in Women With Low Bone Mineral Density
Condition: Osteoporosis
MeSH terms: Osteoporosis; Bone Diseases, Metabolic
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objectives of this study include evaluating the dose response of LY2541546 using
      bone mineral density (BMD) change from baseline as compared to placebo and evaluating the
      overall safety and tolerability of LY2541546 following multiple subcutaneous administrations
      in postmenopausal (PMP) women with low BMD. Following the last dose of study drug,
      participants will be able to participate in a 12 month extension to collect additional safety
      and efficacy data (no further treatment will be administered during this extension).
    


Intervention name(s): LY2541546; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered subcutaneously; Administered subcutaneously
Other intervention name(s): Blosozumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: osteoporosis
Slide Interpretation or Standard Surgical Pathology in Assessing Margin Status in Patients With Pancreatic Cancer Undergoing Surgery
Condition: Pancreatic Cancer; Adenocarcinoma
MeSH terms: Adenocarcinoma; Pancreatic Neoplasms
Study type: Interventional

Summary: 
      This study is being done to investigate another way of evaluating margin status after
      pancreatectomy by using cytopathology (slide interpretation) as compared to the traditional
      method of surgical pathology
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. To compare margin status on final pathology with margin status from cytopathologic
      evaluation.

      OUTLINE:

      Patients undergo cytopathologic sample collection during pancreatic resection during which
      slides are gently pressed against the cut edge of the pancreas, the surgical bed, and along
      the superior mesenteric artery, and finally against the tumor itself.
    

Intervention name(s): cytology specimen collection procedure
Intervention type(s): Other
Intervention description(s): Undergo cytopathologic sample collection
Other intervention name(s): cytologic sampling
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: pancreatic cancer; adenocarcinoma; pancreatic resection
A Study to Compare the Effect of a Double Dose of Two Long-acting Insulin Therapies in Participants With Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary purpose of this study is to compare the effect of a double dose of a study drug
      known as insulin peglispro to a double dose of insulin glargine in participants who have type
      2 diabetes. Participants will be treated with study insulin daily, in two 4-week study
      periods. Each participant will receive insulin peglispro during one treatment period and
      insulin glargine during the other treatment period.
    


Intervention name(s): Insulin Peglispro; Insulin Glargine
Intervention type(s): Drug; Drug
Intervention description(s): Administered SQ; Administered SQ
Other intervention name(s): LY2605541
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Four Dimensions in Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Observational

Summary: 
      Observational, non-interventional, longitudinal, prospective,multicenter, open label (No
      treatment is involved). 4 assessment will be carried out , in months 0, 1, 3 and 6. The
      primary objective is to asses evolution of subjective well-being and depressive symptoms in
      schizophrenic patients for six months after an acute episode treated in outpatient
      psychiatric units. The primary endpoint is: Total score in Subjective Well-being under
      Neuroleptic treatment (SWN-K) and Calgary Depression Rating Scale (CDRS) scales in assessment
      after 6 months vs baseline. Secondary objectives include: To evaluate the relationship
      between subjective well-being and psychopathology, subjective clinical global impression,
      adverse events and compliance of treatment. Also to compare the clinical global impression of
      psychiatrist and patient. In addiction to know the clinical, social and demographic factors
      involve in the subjective well-being and patient clinical global impression.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Schizophrenic patients with a acute episode or worsening of clinical status treated in
        outpatients clinics. Defined acute episode or worsening as clinical status that need a
        significant change in the therapeutic plan.
      
Keywords: Schizophrenia; subjective well-being; depressive symptoms; schizophrenia course
A Study to Evaluate the Safety of STS101 in the Acute Treatment of Migraine
Condition: Migraine; Migraine With Aura; Migraine Without Aura
MeSH terms: Migraine Disorders; Migraine without Aura; Migraine with Aura
Study type: Interventional
Phase: Phase 3

Summary: 
      Study STS101-003 is a multi-center, multiple dose (PRN), open-label, 12-month study to
      evaluate the safety and tolerability of STS101 (dihydroergotamine nasal powder) in the acute
      treatment of migraine.
    

Detailed description: 
      The ASCEND trial is a multi-center, multiple dose (PRN), open-label, 12-month study to
      evaluate the safety and tolerability of STS101 (dihydroergotamine nasal powder) in the acute
      treatment of migraine.
    

Intervention name(s): Dihydroergotamine
Intervention type(s): Drug
Intervention description(s): Dihydroergotamine is a semi-synthetic derivative of ergotamine tartrate.
Other intervention name(s): Dihydroergotamine Mesylate
Intervention MeSH terms: Dihydroergotamine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: dihydroergotamine; dihydroergotamine mesylate; migraine
A Test of Neural Inertia in Humans With Xenon
Condition: Neurocognitive Dysfunction
MeSH terms: Cognitive Dysfunction
Study type: Interventional
Phase: Phase 2

Summary: 
      The dual objectives of this study are to determine if the phenomenon of neural inertia is
      present in humans and to determine whether the order of neurocognitive function is invariant
      among anesthetic agents. This study will enroll 24 healthy volunteers, ages 20-40 years, who
      will receive xenon gas (concentrations ranging from 0% to 60%) delivered via inhaled route
      through the ENHANCER 3000.
    

Detailed description: 
      This is a multimodal, nonrandomized study of healthy subjects. After meeting enrollment
      criteria, subjects will receive a baseline neurocognitive testing on a computer for 15
      minutes and will then receive a wrist watch actigraphy device to record their rest/activity
      patterns over 8-14 days. On the study day (roughly two weeks later), repeat baseline
      neurocognitive testing will be performed after subjects are fitted with a high density EEG
      head cap. The actual intervention (delivery of inhaled xenon gas in stepwise increasing
      followed by decreasing doses) should occur over 2 hours along with verbal tests to assess the
      presence/absence of consciousness at each xenon concentration. Xenon doses have been chosen
      specifically to evaluate the point at which individuals lose and then regain consciousness.
      Doses are escalated up through those used in human anesthesiology (75%) that permit surgery.
      After exposure, serial neurocognitive testing will occur every 30 minutes for 3 hours post
      emergence. Subjects are discharged from the study's intervention day to home only upon
      reaching standard post-anesthesia care unit criteria (modified Aldrete score ≥9). A
      post-procedure follow up phone call will occur within 24 hours of anesthetic exposure to
      ensure that the subject remains well. The individual's involvement is completed upon
      returning the Actigraphy watch 1 week after the exposure day. The expected duration of
      subject participation is 3 weeks.
    

Intervention name(s): Xenon
Intervention type(s): Drug
Intervention description(s): drug given in concentrations of 0% to 60% over period of 2 hours
Intervention MeSH terms: Xenon
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: neurocognitive function; neural inertia; xenon gas
The Influence of Obesity on Level of Depression and Cognitive and Executive Functions
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The proposed study is a randomized, open, comparative research involving an intervention
      group and two control groups.

      The aims of the study are: 1.To compare levels of depression in female adolescents with
      obesity and a control group of female adolescents with appropriate weight and height. 2. To
      investigate whether a decrease in weight due to a short range intervention program provided
      by dietician for female adolescents with obesity will lead to change in the levels of
      symptoms of depression and cognitive and executive functions in comparison to a control group
      of adolescent girls with obesity, matched in age that does not receive such an intervention
      program.

      60 Female adolescents with obesity will be recruited to the study and will be randomized to 1
      of two groups- 1. intervention group- participants in this group will attend an intervention
      program consisting of 12 meetings with dietician and will attend two study visits at the
      clinic- in the beginning of the study and after three months. 2.Control group- Participants
      in this group will only come to two study visits at the clinic. In the first two visits they
      will meet with a dietician and will receive nutrition guidance.

      Another 30 girls with appropriate weight will be recruited to second control group- this
      group will come to two study visits at the clinic- in the beginning of the study and after
      three months. In the first visit participants will receive nutrition guidance by the
      dietician.

      In the study visits the following procedures will be performed for all study groups: Blood
      tests, completion of psychological and nutritional questionnaires, completion of computerized
      tests and measurements of height, weight, fat mass and circumference of hips.
    


Intervention name(s): Nutritional guidance intervention; Nutritional guidance intervention
Intervention type(s): Behavioral; Behavioral
Intervention description(s): participants in this group will attend 12 meeting of nutritional guidance; Participants in this group will only receive nutrition guidance once during the study
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Lifestyle Heart Trial
Condition: Cardiovascular Diseases; Coronary Arteriosclerosis; Coronary Disease; Heart Diseases; Hypercholesterolemia; Hypertension; Myocardial Ischemia
MeSH terms: Cardiovascular Diseases; Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Arteriosclerosis; Hypercholesterolemia; Ischemia
Study type: Interventional
Phase: Phase 2

Summary: 
      To assess long-term effects of a strict lifestyle change program on lipids, blood pressure,
      myocardial perfusion, and coronary atherosclerosis.
    

Detailed description: 
      BACKGROUND:

      The trial was the first randomized, controlled trial to determine whether patients outside a
      hospital could be motivated to make and sustain comprehensive lifestyle changes and whether
      coronary disease regression could occur as a result of lifestyle changes alone.

      DESIGN NARRATIVE:

      Patients were randomly assigned to an experimental group or to a usual-care group.
      Experimental-group patients were prescribed a lifestyle program including a low-fat
      vegetarian diet, moderate aerobic exercise, stress management training, stopping smoking, and
      group support. No animal products were allowed in the vegetarian diet except egg white and
      one cup per day of non-fat milk or yogurt. The diet contained approximately 10 percent of
      calories as fat. Control-group patients were not asked to make lifestyle changes. Coronary
      angiography was performed at baseline and at one year to assess progression or regression of
      disease. Patients were recruited into the trial between January 1986 and November 1988. The
      trial was supported prior to April 1989 from various sources other than the National Heart,
      Lung, and Blood Institute. Follow-up continued for four years.

      The study completion date listed in this record was obtained from the Query/View/Report (QVR)
      System.
    

Intervention name(s): diet, vegetarianism; diet, fat-restricted; exercise; smoking cessation
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Allocation: Randomized
Primary purpose: Prevention