bioihbjkbjnl/mcl2 huggingface dataset:
A Bioequivalence Study of Film-coated Tablet and Dry Syrup 1% Form for E2020 in Healthy Japanese Adult Males
Condition: Healthy Adult
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to confirm bioequivalence between E2020 dry syrup 1% form (0.5
      g), given either with 200 mL of water or suspended in 20 mL of water, and E2020 film-coated
      tablet (5 mg) in Japanese healthy adult males.
    


Intervention name(s): Donepezil Hydrochloride; Donepezil Hydrochloride; Donepezil Hydrochloride
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Drug E2020 film-coated tablet: E2020 film-coated tablet (5mg) orally administered in a single dose with 200 mL water.; Drug E2020 dry syrup 1% form (suspended): E2020 dry syrup 1% (0.5 g) will be orally administered in a single dose after suspended in 20 ml water.; Drug E2020 dry syrup 1% form: E2020 dry syrup 1% (0.5 g) will be orally administered in a single dose with 200 mL water.
Intervention MeSH terms: Donepezil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Bioequivalence; Healthy Subjects; Donepezil
Arimidex Multicenter Trial in Growth Hormone (GH) Deficient Boys
Condition: Hypopituitarism
MeSH terms: Hypopituitarism
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to see if Arimidex, an aromatase inhibitor, can delay epiphyseal
      fusion and increase predicted adult height in boys who are growth hormone deficient, in
      puberty, and who are taking growth hormone. This is a double blind, placebo controlled 3 year
      trial.
    


Intervention name(s): Arimidex (Anastrozole); Placebo; Growth Hormone
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Subjects will be randomized in a 1:1 ratio to be given either Arimidex 1 mg or placebo orally. Subjects will receive trial treatment for 36 months while continued on GH.; Subjects will be randomized in a 1:1 ratio to be given either Arimidex 1 mg or placebo orally. Subjects will receive trial treatment for 36 months while continued on GH.; GH (Nutropin®, Genentech, So. San Francisco, CA) will be administered throughout the trial at a dose of ~0.3mg/kg.w (no more than 0.4mg/kg.w) given subcutaneously (SC) at bedtime daily. Dose adjustments on the GH dose will be made by the investigator at least every 6mo.
Intervention MeSH terms: Anastrozole; Hormones
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: Puberty; Growth hormone deficiency; aromatase inhibitors; estrogen; bone mineral density; short stature
Safety, Tolerability, Efficacy and Optimal Dose Finding Study of BAF312 in Patients With Relapsing-remitting Multiple Sclerosis
Condition: Relapsing-remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study was to determine the dose-response curve for the MRI-based efficacy
      of BAF312 compared with placebo in patients with Relapsing-Remitting Multiple Sclerosis
      (RRMS), and to characterize its safety and tolerability for the selection of an optimal dose
      in a later phase III study.

      Study Design Rationale An adaptive design was chosen to characterize the dose response curve
      of BAF312. In a first period of study ("Period 1"), three doses of BAF312 and placebo were
      tested for MRI efficacy. Based on an interim analysis (IA) after 3 months of treatment, two
      additional active doses for period 2 wereselected , thus allowing to optimize the overall
      determination of the dose response curve with 5 data points of active treatment, and placebo.
      The doses were kept blinded. The use of Modeling and Simulation allowed to establish the full
      range and dynamics of the dose-response curve in silico, and hence the definition of the
      optimal dose for later phase III studies.

      The choice of placebo as treatment control was essential to obtain information on the
      specific compared to non-specific effects of active treatment and provides the best way of
      evaluating the efficacy and of assessing the true safety and tolerability profile of BAF312.
      Short-term placebo exposure (6 (Period 1) or 3 (Period 2) months, respectively) was unlikely
      to lead to longer term differences in outcomes [Polman, 2008]. The use of an adaptive design
      strategy contributed to a significant reduction of placebo exposure, both in terms of the
      number of patients and duration, as compared to conventional trial models.

      Patients having completed the study within the protocol might be eligible for the Extension
      Phase study where they receive long-term BAF312 treatment (a separate protocol).
    


Intervention name(s): BAF312; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Siponimod
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Multiple Sclerosis (MS); Relapsing-Remitting; Demyelinating Autoimmune Diseases; Disseminated sclerosis; Encephalomyelitis disseminate; Inflammatory disease; Demyelination; Auto-inflammatory disease; Devic's disease; Balo concentric sclerosis; Schilder's diffuse sclerosis
Bevacizumab and Erlotinib or Sorafenib as First-Line Therapy in Treating Patients With Advanced Liver Cancer
Condition: Liver Cancer
MeSH terms: Liver Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different
      ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and
      help kill them or carry tumor-killing substances to them. Erlotinib and sorafenib may stop
      the growth of tumor cells by blocking some of the enzymes needed for cell growth.
      Bevacizumab, erlotinib, and sorafenib may also stop the growth of tumor cells by blocking
      blood flow to the tumor. It is not yet known whether giving bevacizumab together with
      erlotinib is more effective than giving sorafenib in treating patients with liver cancer.

      PURPOSE: This randomized phase II trial is studying how well giving bevacizumab together with
      erlotinib works compared with sorafenib as first-line therapy in treating patients with
      advanced liver cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  To estimate the overall survival in patients with advanced hepatocellular carcinoma
           treated with bevacizumab and erlotinib hydrochloride vs sorafenib tosylate.

      Secondary

        -  To estimate the event-free survival and tumor response rate of these patients.

        -  To evaluate the safety and tolerability of these regimens in these patients.

      OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.

        -  Arm I: Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral
           erlotinib hydrochloride once daily on days 1-28.

        -  Arm II: Patients receive oral sorafenib tosylate twice daily on days 1-28. In both arms,
           courses repeat every 28 days in the absence of disease progression or unacceptable
           toxicity.

      After completion of study treatment, patients are followed at 30 days and then every 3 months
      for 1 year.
    

Intervention name(s): bevacizumab; erlotinib hydrochloride; sorafenib tosylate
Intervention type(s): Biological; Drug; Drug
Intervention description(s): Given IV; Given orally; Given orally
Intervention MeSH terms: Bevacizumab; Erlotinib Hydrochloride; Sorafenib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adult primary hepatocellular carcinoma; advanced adult primary liver cancer; recurrent adult primary liver cancer
Safety and Feasibility of a Novel In--Bed Resistance Training Device in Elderly Inpatients
Condition: Old Age; Debility
MeSH terms: Frailty
Study type: Interventional

Summary: 
      The purpose of this study is to decrease deconditioning of elderly inpatients in acute care
      institutions and to assess the safety and feasibility of a newly developed resistance
      training device. Investigators believe this device will help hospitalized seniors maintain
      their independence by preventing the loss of functionality from deconditioning and improve
      value of care through decreased length of stay and utilization of care. Current therapy will
      be complemented with a new in--bed resistance training device to target weak elderly patients
      and standardize progressive resistance training in facilities.
    


Intervention name(s): In-Bed Resistance Training Device; Standard of Care
Intervention type(s): Other; Other
Intervention description(s): Physical Therapy using the in bed training device; Does not include early implementation of physical therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: deconditioning of elderly inpatients; loss of functionality
Can Diffusion Tensor Imaging (DTI) of the Optic Ways Contributes to Predict the 6 Months Prognosis of Optic Neuritis (ON)?
Condition: Optic Neuritis
MeSH terms: Neuritis; Optic Neuritis
Study type: Interventional

Summary: 
      Can diffusion tensor imaging (DTI) of the optic ways contributes to predict the 6 months
      prognosis of Optic Neuritis (ON)?
    


Intervention name(s): MRI
Intervention type(s): Device
Intervention description(s): MRI in diffusion tensor (DTI : Diffusion Tensor Imaging)
Intervention model: Single Group Assignment
Intervention model description: Interventional pilot study with minimal risks and constraints, descriptive, prospective, monocentric
Masking: None (Open Label)
Primary purpose: Other
Investigation of Iron Uptake From Micronutrient Fortified Powder Versus From Tailored Control in Milk
Condition: Growth and Development
Study type: Interventional

Summary: 
      The present study supplements iron as part of multiple micro-nutrient supplementation to
      demonstrate that intake of a micronutrient fortified powder in milk helps increase the uptake
      of key micronutrients like iron due to unique nature of the given matrix, as compared to
      intake of iron alone in milk.
    


Intervention name(s): Test; Control
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Experimental product: Micronutrient fortified beverage powder, packed as 27 g individual sachet, administered orally as a single serve.; Energy equivalent beverage powder without micronutrient fortification, packed as 27 g individual sachets, administered orally as a single serve
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Minocycline's Effects on Alcohol Responses in Humans
Condition: Alcohol Dependence
MeSH terms: Alcoholism
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a double-blind, placebo-controlled, outpatient study with a between-groups design.
      Sixty male and female heavy social drinkers will be randomly assigned to minocycline (200 or
      400 mg/day) or placebo for 10 days. In the first 7 days of treatment, subjects will have 3
      outpatient visits for medication administration, dispensing of take-home doses and monitoring
      of any adverse effects from study medications. On days 8 and 10 of treatment, subjects will
      have 2 laboratory sessions where alcohol or placebo will be administered intravenously using
      a clamp procedure. Alcohol administration will use a breath alcohol concentration (BrAc)
      method, targeting 100 mg %. The alcohol clamp procedure will allow collection of multiple
      outcome measures including subjective, motor, cognitive measurement and plasma cytokine
      levels.
    


Intervention name(s): Minocycline; Placebo (for Minocycline)
Intervention type(s): Drug; Drug
Intervention MeSH terms: Minocycline
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Alcohol Dependence; Minocycline
Innervation of Human Cricopharyngeal Muscle By Recurrent Laryngeal and External Branch of Superior Laryngeal Nerve
Condition: Larynx
Study type: Interventional

Summary: 
      The investigators hypothesized that, external branch of the superior laryngeal nerve (EBSLN)
      and/or recurrent laryngeal nerve (RLN) contribute to the motor function of the human
      cricopharyngeal muscle (CP). The investigators aimed to assess the contribution of the
      laryngeal nerves (EBSLN and RLN) to the motor activity of the cricopharyngeal muscle, during
      thyroidectomy with intraoperative neuromonitoring (IONM).
    

Detailed description: 
      This study group consisted of a consecutive patients undergoing thyroid surgery with
      intraoperative neuromonitoring (NIM 3.0 Nerve Monitoring Systeme (Medtronic Xomed,
      Jacksonville, FL, USA) ) for various diseases. In all patients, each side of the neck
      operated was considered as a separate entity in our study.

      EMG recordings were accomplished with a pair of needle electrodes inserted into the CP and
      mid-portion of the CT muscle that is located on the superior side of the RLN, which were
      plugged into the third and fourth channels of interface-connector box, respectively, at the
      end of the thyroidectomy or lobectomy. The investigators evaluated the innervation pattern of
      the CT muscle in an other study. Therefore the EBSLN is the main supplier of the CT muscle,
      the EMG findings of the CT muscle were used to confirm it, in this study.

      EBSLN, pharyngeal plexus (PP), RLN and vagus nerve were stimulated with a monopolar
      stimulator probe at 1 mA. While stimulating these nerves, the ipsilateral CP muscle was
      visually observed for possible contractions and electromyographic recordings were obtained
      with the 4-channel NIM 3.0 Nerve Monitoring System.
    

Intervention name(s): The NIM 3.0 Nerve Monitoring System
Intervention type(s): Device
Intervention description(s): Electromyography recordings were accomplished with a pair of needle electrodes inserted through the CP muscle, which were plugged into the third and fourth channels of interface-connector box.The recurrent laryngeal nerve(RLN), vagus nerve, external branch of the superior laryngeal nerve(EBSLN) and pharyngeal plexus were stimulated with a current of 1 mA and a frequency of 4 MHz and the event threshold at 100 microV.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: cricopharyngeal muscle; innervation by EBSLN; A prospective case-controlled study
Attention Bias Modification Treatment for Young Adults With Major Depressive Disorder
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional

Summary: 
      In this study, the investigators test whether a 4-week 12-session attention bias modification
      treatment (ABMT) could reduce depressive symptoms relative to placebo controls in young
      adults with major depressive disorder at post-training and 3-month follow-ups. Meanwhile, the
      investigators also test whether a 2-week 4-session ABMT booster training for every three
      months could reduce residual depressive symptoms and recurrences relative to placebo controls
      for 1-year follow-up
    

Detailed description: 
      Attention Bias Modification Training was a modified dot-probe task, in which 90% of the
      targets appeared at the neutral word position and 10% at the sad word position. The placebo
      training procedure is a classic dot-probe task in which the targets appeared with equal
      probability in the sad (50%) and neutral (50%) word positions. The investigators assess
      attention bias scores, depressive symptoms, trait anxiety, rumination and self-report
      attention control ability at 1-week, 2-week, 4-week,7-week,3-month,4-month, 5-month, 6-month
      and 12-month follow-ups after training.
    

Intervention name(s): Attention bias modification
Intervention type(s): Behavioral
Intervention description(s): The ABM training task was a variation of the computerized visual dot-probe task. During the training, each session includes 54 neutral-sad word pairs presenting 6 times (6 × 54=324 trials) during 20-minute. Participants received 12 sessions over 4 weeks (1 session every other day). In the active ABMT, 90% of the probes appeared at the neutral position and 10% at the sad position. At the placebo ABMT, 50% of the probes appeared at the neutral position and 50% at the sad position.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Particpants are assigned to active ABM treatment or placebo training
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Attenion bias modification, major depression, treatment
Bioequivalence Study of Metoprolol Succinate ER Tablets, 200 mg Under Fasting Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to monitor adverse events, safety and tolerance Metoprolol
      Succinate Extended-Release Tablets 200 mg under fasting conditions
    

Detailed description: 
      An open label, balanced, randomized, two-treatment, two-period, two sequence, single dose,
      crossover, oral bioequivalence study of Metoprolol Succinate Extended-Release tablets 200mg
      of Dr. Reddy's Laboratories Limited,under fasting conditions
    

Intervention name(s): Metoprolol Succinate
Intervention type(s): Drug
Intervention description(s): Metoprolol Succinate ER Tablets 200 mg
Other intervention name(s): TOPROL-XL®
Intervention MeSH terms: Metoprolol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Theta Burst Study Ghent
Condition: Unipolar Major Depression
MeSH terms: Depression
Study type: Interventional

Summary: 
      50 Right-handed antidepressant-free unipolar depressed patients (age 18-65 years) will be
      treated with in total 20 Theta burst sessions; these will be spread over 4 days. On each
      stimulation day, a given patient shall receive 5 sessions with a between session delay of 10
      to 15 minutes. Patients will be selected using the structured Mini-International
      Neuropsychiatric Interview (MINI). All will be at least stage I treatment resistant. Because
      concomitant antidepressant treatment can confound outcome results, all patients will go
      through a medication washout before entering the study and they will be free from any
      antidepressant, neuroleptic and mood stabilizer for at least two weeks before entering the
      treatment protocol. Only habitual benzodiazepine agents will be allowed.

      All patients will be closely matched for gender and age with 50 never-depressed
      medication-free healthy volunteers. Only baseline measurements will be collected: no
      volunteer will undergo the treatment.

      We expect that real Theta burst treatment and not sham will result in a significant and
      clinical meaningful response.
    


Intervention name(s): Theta burst stimulation.
Intervention type(s): Other
Intervention description(s): In each session, subjects will receive 54 Theta burst trains of 2 seconds duration, separated by an intertrain interval of 18 seconds, delivered on the left dorsolateral prefrontal cortex (DLPFC). The treatment protocol of in total 20 Theta burst sessions will be spread over 4 days, yielding a total of 32400 stimuli. On each stimulation day, a given patient shall receive 5 sessions with a between session delay of 10 to 15 minutes.
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: depression
Is Patient Choice of Exercise Preference Important in Chronic Neck Pain?
Condition: Chronic Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      Nonspecific chronic neck pain is the third most frequent problem in Spain. It has an annual
      presence between 15% and 50% where women are the most affected. This pain influences the
      psychosocial state of the person. Physical exercise has been shown to be effective in a wide
      variety of chronic pain conditions, including improving quality of life and emotional
      problems. Design: Single-blind, controlled, randomized clinical trial. Methods: The study
      will be approached in the Faculty of Nursing and Physiotherapy of the University of Alcalá.
      52 subjects with nonspecific chronic neck pain will be selected and randomly divided into two
      groups. The first group should perform 5 exercises that have been shown to be effective in
      the management of neck pain selected by the physiotherapist focused on neck pain. The second
      group must choose, from a list of exercises that have been shown to be effective in the
      management of neck pain, 5 exercises. Both groups should record the pain, the number of
      repetitions and the series performed. The duration of the intervention will be a total of 8
      weeks with evaluations pre-intervention, post-intervention and 4 weeks after the end of the
      intervention. The objective of this study is to evaluate if the exercise chosen by the
      patient is better than the exercises selected by the physiotherapist for the variables
      chronic neck pain, strength of the affected muscles, kinesiophobia and adherence to
      treatment.
    


Intervention name(s): prescribed exercise; chosen exercise
Intervention type(s): Other; Other
Intervention description(s): the therapist chooses the five exercises to do; the patient chooses the five exercises to perform among fifteen possibilities
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Chronic neck pain; Physical Exercise; Kinesiophobia; Cervical strength; Adherence to treatment