bioihbjkbjnl/mcl2 huggingface dataset:
Pharmacokinetics and Tolerability of Sulthiame
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional
Phase: Phase 1

Summary: 
      This preliminary pilot exploration aims at specifying the pharmacokinetic parameters of
      sulthiame, formulated as an immediate release tablet, thus helping to design proper clinical
      trials for the future assessment of new paediatric formulations currently under development.
      The clinical tolerability to single doses of sulthiame will also be closely monitored to
      orient future trials.
    

Detailed description: 
      Sulthiame (or sultiame), marketed in the 60's in Germany, Austria, Switzerland, Israel,
      Australia and Japan under the brand name Ospolot®, has progressively become the therapeutic
      first choice in benign focal epilepsies of childhood in these countries.

      Its antiepileptic activity is thought to result from the inhibition of various subtypes of
      carbonic anhydrase (hCA), in particular cytosolic hCA II, thus inducing a degree of
      intracellular acidification sufficient to stabilize seizure-eliciting neurons. The
      pharmacokinetic profile of sulthiame was scarcely studied in humans.

      Sulthiame is a suitable candidate for paediatric formulation optimization, as the current
      formulation (coated tablets of 50 or 200 mg) allows neither precise and adapted dosing, nor
      convenient administration to young children.
    

Intervention name(s): Sulthiame
Intervention type(s): Drug
Intervention description(s): Single dose (50, 100, 200 mg)
Other intervention name(s): Ospolot
Intervention MeSH terms: Sulthiame
Intervention model: Single Group Assignment
Intervention model description: Phase I, single centre, prospective, ascending single oral doses, open-label, 3-period clinical trial
Masking: None (Open Label)
Primary purpose: Other
Evaluation of Topical Lidocaine Spray as Adjuvant to Upper Gastrointestinal Endoscopy in Children
Condition: Dyspepsia; Malabsorption Syndrome; Gastroesophageal Reflux Disease; Abdominal Pain
MeSH terms: Gastroesophageal Reflux; Malabsorption Syndromes; Dyspepsia; Abdominal Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      There is some controversy in the medical literature regarding the effectiveness of topical
      lidocaine in children as an adjuvant drug to upper gastrointestinal endoscopy. In children,
      deep sedation and general anesthesia are often used to sedate children submitting to this
      procedure. Propofol is an anesthetic drug increasingly popular in this situation, but this
      drug can only be used with an anesthesiologist in Brazil. Its main side effects include
      hypotension, respiratory depression and local pain. Lidocaine is frequently used as
      premedication, and the rationale is that lowering patient discomfort could lower the required
      dose to achieve the endoscopy and reduce potential side effects. Nevertheless, some patients
      perceive this medication as uncomfortable. This study aims to compare sedative drug doses
      between patients who were given either placebo or topical lidocaine.
    

Detailed description: 
      This study is a randomized double-blind placebo-controlled clinical trial.

      Primary outcome: propofol doses required to achieve adequate sedation.

      Population: children submitting to upper digestive endoscopy, weight > 30 kg and age between
      8 and 18 years.

      Exclusion criteria: neurological disorders, psychiatric disorders, specific contra-indication
      to either lidocaine or propofol.

      Estimated sample: 160 patients. Placebo: tannic acid 0.5%
    

Intervention name(s): Lidocaine; Tannic acid
Intervention type(s): Drug; Drug
Intervention description(s): oral cavity and throat were sprayed with lidocaine 10% two to three puffs before propofol infusing; oral cavity and throat were sprayed with placebo (tannic acid 0.5%) two to three puffs before propofol infusing
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: endoscopy, gastrointestinal; lidocaine; propofol; child; adolescent
Oestrogen Withdrawal in Hypopituitary Women
Condition: Hypopituitarism
MeSH terms: Hypopituitarism
Study type: Interventional

Summary: 
      By exploring hormonal status in hypopituitary women during oestrogen treatment and without
      estrogen substitution the influence on sexhormones and organ function is estimated.
    

Detailed description: 
      38 hypopituitary women were examinined twice. During oestrogen treatment and after 1 month
      estrogen withdrawal. A control group of healthy women were examined once.Antropometric data
      and hormonal parameters were collected.
    

Intervention name(s): oestrogen
Intervention type(s): Drug
Intervention description(s): Cyclic oestrogen substitution therapy
Intervention MeSH terms: Estrogens
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Effect of RNS60 on the Late Phase Asthmatic Response to Allergen Challenge
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      The study will investigate the effect of treatment with RNS60 for 21 days. Subjects' FEV1
      will be measured after an inhaled allergen challenge at baseline and again after 21 days of
      treatment.
    

Detailed description: 
      This is a randomized, placebo-controlled, parallel study in approximately 32 male and female
      subjects with mild asthma. Each subject will receive either the experimental or the placebo,
      administered as a nebulized dose twice daily for 21 days.
    

Intervention name(s): RNS60; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: RNS60
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Ginger Capsules for the Acute Treatment of Migraine Attacks
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional

Summary: 
      The main objective of the study was to evaluate ginger efficacy as an adjuvant to ketoprofen
      for the treatment of headache and other symptoms related with migraine attacks.
    

Detailed description: 
      Patients with the diagnosis of migraine according to the International Headache Society (IHS)
      criteria were enrolled in the study during a migraine attack. Patients received two 200 mg
      capsules of dry ginger extract (5% active ingredient) or two capsules of placebo (cellulose)
      in addition to an intravenous dose of ketoprofen (100 milligrams - mg) to treat the migraine
      attack.
    

Intervention name(s): Extract of ginger; Cellulose; Intravenous ketoprofen
Intervention type(s): Dietary Supplement; Other; Drug
Intervention description(s): People (both genders) who went to the emergency room of the Hospital Vera Cruz (Belo Horizonte, MG, BR) with a migraine attack received two capsules of ginger extract (containing 5% of gingerols).; People (both genders) who went to the emergency room of the Hospital Vera Cruz (Belo Horizonte, MG, BR) with a migraine attack received two placebo capsules (cellulose).; People (both genders) who went to the emergency room of the Hospital Vera Cruz (Belo Horizonte, MG, BR) with a migraine attack received intravenous ketoprofen (100mg).
Other intervention name(s): Phytotherapy; Placebo; Nonsteroidal anti-inflammatory drug
Intervention MeSH terms: Ketoprofen; Anti-Inflammatory Agents, Non-Steroidal; Anti-Inflammatory Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Migraine; Ginger; Acute treatment
A Study of LY2605541 Versus Insulin Glargine on Blood Sugar
Condition: Healthy Volunteers; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      LY2605541 is an investigational drug being developed for the treatment of diabetes mellitus.
      This study is designed to understand how the body handles the investigational drug, what
      effect this investigational drug has on the body, and how much should be given. This study
      will also measure how much of the investigational drug gets into the blood stream and how
      long it takes the body to get rid of it. The study has 2 parts: Part A will be conducted in
      healthy participants. Part B will be conducted in participants with type 1 diabetes mellitus
      (T1DM). This study will take approximately 10-14 days spread over 6-20 weeks, not including
      screening. Screening will be performed within 30 days of the start of the study.
    


Intervention name(s): LY2605541; Insulin glargine
Intervention type(s): Drug; Other
Intervention description(s): LY2605541 is a solution. The concentration of LY2605541 is 100 units/milliliter (U/mL).; Insulin glargine is a 100 U/mL solution in 10 milliliter (mL) glass vial.
Intervention MeSH terms: Insulin Glargine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
A 1-year Trial to Inform About Long-term Exposure to Eptinezumab in Participants With Chronic Cluster Headache (cCH)
Condition: Chronic Cluster Headache
MeSH terms: Cluster Headache; Headache
Study type: Interventional
Phase: Phase 3

Summary: 
      The main goal of this trial is to inform about long-term safety and tolerability of
      eptinezumab in participants with chronic cluster headache.
    

Detailed description: 
      The participants who take part in this trial will be asked to stay in the trial for about a
      year. The participants will be asked to visit the trial site 7 times during the trial. In
      between trial site visits, they will have scheduled phone calls with the trial site staff.
      They will also be asked to keep track of their cluster headaches at home with a headache
      diary.
    

Intervention name(s): Eptinezumab
Intervention type(s): Drug
Intervention description(s): Eptinezumab will be administered per schedule specified in the arm description.
Other intervention name(s): Vyepti
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effect of Task-Oriented Training in Patients With Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      It is reported that 85% of MS patients have gait disturbance, 87.9% balance, 35-90% fatigue
      and 45-60% cognitive problems. Rehabilitation approaches based on the motor control systems
      model, the plasticity concept, the motor learning principles, have been found to be effective
      for solving these problems. With these rehabilitation approaches, it is aimed to develop the
      ability of the person to meet the task and environmental demands and to realize the highest
      quality and the right function with maximum potential by consuming the least energy in
      different environmental conditions of different tasks. "Task-oriented training" may be one of
      the most effective among the evidence-based rehabilitation approaches for these goals.

      The purpose of this study is to determine the effect of "Task-Oriented Training" on the
      physical and cognitive functions in patients with multiple sclerosis.
    

Detailed description: 
      The study was designed as a randomized, controlled, single-blind trial. The patients will be
      randomly assigned to two groups, the "task-oriented training" group, and the control group.
      "Task-oriented training" consisting of 10 different motor tasks including lower extremity and
      upper extremity activities will be applied to the training group twice a week for 6 weeks.
      The control group will be taught relaxation exercises and will be asked to perform the
      exercises 2 times for 6 weeks at home.

      Statistical analyses will be performed using the SPSS software version 15 (SPSS Inc. Chicago,
      IL, USA). The pre-training and post-training measurements of groups will be compared with the
      Wilcoxon Test. The significance level was set at p< 0.05.
    

Intervention name(s): Task-oriented training
Intervention type(s): Other
Intervention description(s): "Task-oriented training" consisting of 10 different motor tasks including lower extremity and upper extremity activities will be applied to the training group twice a week for 6 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, controlled, single-blind trial
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Multiple Sclerosis; task-oriented training; physical performance; cognition
Temperament and Character Traits in Young Men With Idiopathic Scoliosis
Condition: Idiopathic Scoliosis
MeSH terms: Scoliosis
Study type: Observational [Patient Registry]

Summary: 
      This study was designed to investigate whether the temperament and character traits of young
      men with idiopathic scoliosis differ from healthy individuals of the same age group and
      characteristics.
    

Detailed description: 
      All patients who applied to the orthopedics and traumatology department between July 2017 and
      June 2018 for a medical board examination were evaluated by physical and radiological
      examination. According to the Cobb method, individuals with a Cobb angle greater than 10°
      were diagnosed with Idiopathic Scoliosis. In the same period, healthy individuals who applied
      for the same examination and met the inclusion criteria were determined as the control group
      by random sampling method. All participants were evaluated by a senior psychiatrist. Before
      the interview, all subjects fully informed about the purpose and scope of the study. After
      their permission was obtained the study and control groups completed a socio-demographic data
      form consisting of questions about detailed personal and medical history and, the
      participants were asked to fill in the TCI.
    

Intervention name(s): X-ray radiograghy
Intervention type(s): Radiation
Intervention description(s): Cobb angles of the patient and control groups were determined by using X-Ray radiography used in the radiological examination routinely applied to the individuals who applied for the health board examination.
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patient group: 162 person Control group: 162 person
      
Keywords: Idiopathic scoliosis; temperament; character; personality; persistence; novelty-seeking
Mometasone Furoate and Oxymetazoline in the Treatment of Adenoid Hypertrophy
Condition: Adenoidal Hypertrophy
MeSH terms: Hypertrophy
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine the effect of MF/OXY in the treatment of adenoid
      hypertrophy children with severe allergic rhinitis.
    

Detailed description: 
      The investigators performed a two stages, parallel, randomized, double-blind, double-dummy,
      clinical trial in 240 AH children concomitant with perennial allergic rhinitis. In the first
      treatment stage, the 240 children were assigned to MF (50μg, 1 puff in each nostril every
      evening) or control group (normal saline) after two week's run-in period. After 6 week's
      treatment, the children in MF group were evaluated and grouped as responders and
      non-responders according to subjective symptoms and objective performance.

      Responders were followed up for six months and reassessed. Non-responders underwent 2-week
      washout period and were randomly assigned to 4 groups receiving the following treatments:
      placebo, OXY (0.05%, 1 puff in each nostril every evening) or MF (50μg, 1 puff in each
      nostril every evening). All participants received 8 weeks' MF or its placebo plus one week's
      OXY or its placebo for every second week. After that, the patients were followed for six
      months and the evaluation was done at different time points.
    

Intervention name(s): mometasone furoate; Placebo; Oxymetazoline + Placebo; Placebo + placebo; mometasone furoate + Placebo; mometasone furoate + Oxymetazoline
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 50μg, 1 puff in each nostril every evening; 1 puff in each nostril every evening; 1 puff of Oxymetazoline +1 puff of Placebo in each nostril every evening; 1 puff of placebo +1 puff of Placebo in each nostril every evening; 1 puff of mometasone furoate +1 puff of Placebo in each nostril every evening; 1 puff of mometasone furoate +1 puff of Oxymetazoline in each nostril every evening
Other intervention name(s): NASONEX; Oxymetazoline Hydrochloride Spray + Placebo; Placebo; NASONEX + Placebo; NASONEX + Oxymetazoline Hydrochloride Spray
Intervention MeSH terms: Mometasone Furoate; Phenylephrine; Oxymetazoline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Rescue of Steroidogenic Capacity in Adrenocortical Failure Study (RADS)
Condition: Autoimmune Adrenocortical Failure
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a pilot study of B lymphocyte depletion therapy in an attempt to salvage adrenal
      steroidogenic capacity in ten subjects with early autoimmune Addison's disease. During the
      first twelve weeks of treatment, additional glucocorticoid therapy (prednisolone) will be
      given to ensure wellbeing and to rest the steroidogenic apparatus that is the target of the
      autoimmune attack. Glucocorticoids will be gradually withdrawn, in a controlled fashion, and
      adrenal function re-evaluated at 13, 26, 39 and 52 weeks. The primary endpoint will be
      restoration of steroidogenic function as judged by conventional endocrine indices of
      adrenocortical function. B cell depletion may ameliorate the autoimmune attack against
      adrenal cells, potentially allowing a state of immune tolerance to be restored with
      subsequent recovery of adrenal steroidogenic capacity.
    


Intervention name(s): Solu-medrone, Mabthera
Intervention type(s): Drug
Intervention description(s): 125mg, 1gram, twice day 1 and day 15
Intervention MeSH terms: Rituximab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: B cell depletion; steroidogenesis
Simple Home-Based Exercise for Knee Osteoarthritis
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      1. Simple home-based standing balance training and isometric knee extension exercise for 4
           weeks would improve functional ability and knee muscle strength of patients with knee
           osteoarthritis.

        2. The outcome of standing balance training is different from isometric knee extension
           exercise.
    


Intervention name(s): Standing balance exercise; Isometric knee extension exercise
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Standing balance and mini squat exercise performed 30 times/day/side, 5 days/week, for 4 weeks.; Isometric knee extension exercise performed 10 repetitions/set, 3 sets/day, 5 days/week for 4 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: osteoarthritis; knee; exercise; balance
Safety and Tolerability of MEDI3506 in Healthy Participants, in Participants With COPD and Healthy Japanese Participants
Condition: Part I (SAD) - Healthy Participants; Part II (MAD) - Chronic Obstructive Pulmonary Disease; Part III (J-SD) - Healthy Japanese Participants
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, randomised, blinded, placebo controlled, study designed to evaluate the
      safety, tolerability, pharmacokinetics, and immunogenicity response to single and multiple
      doses of MEDI3506.
    

Detailed description: 
      This is a Phase 1, randomised, blinded, placebo controlled, study designed to evaluate the
      safety, tolerability, pharmacokinetics, and immunogenicity response to single and multiple
      doses of MEDI3506 administered by either subcutaneous (SC) or intravenous (IV) routes.

      Part I: Single Ascending Doses in Healthy Participants with a History of Mild Atopy

      Part II: Multiple Ascending Doses in Participants with Global Initiative for Chronic
      Obstructive Lung Disease (GOLD) I-II Chronic Obstructive Pulmonary Disease (COPD)

      Part III: Single Dose in Healthy Japanese Participants
    

Intervention name(s): MEDI3506; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Healthy participants with a history of mild atopy and proven sensitivity to HDM will receive a single MEDI3506 Dose 1 or Dose 2 or Dose 3 or Dose 4 or Dose 5 or Dose 6 subcutaneously and Dose 6 intravenously in Part 1. Participants with COPD will receive 3 administration of MEDI3506 Dose 4 or Dose 5 or Dose 6 subcutaneously two weeks apart over a 4-week dosing period in Part 2. Healthy Japanese participants will receive a single dose of MEDI3506 Dose 6 intravenously in Part 3.; Healthy participants with a history of mild atopy and proven sensitivity to HDM will receive a single dose of placebo matched to MEDI3506 subcutaneously or intravenously in Part 1. Participants with COPD will receive 3 administration of placebo matched to MEDI3506 subcutaneously two weeks apart over a 4-week dosing period in Part 2. Healthy Japanese participants will receive a single dose of placebo matched to MEDI3506 intravenously in Part 3.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: MEDI3506; Safety; Tolerability; Pharmacokinetics; Immunogenicity
Effect of Paraprobiotic Lactobacillus Plantarum IS-10506 on Humoral Immune Response of Elementary School Children
Condition: Humoral Immune Response
Study type: Interventional

Summary: 
      This study is aimed to determine effect of paraprobiotic Lactobacillus plantarum IS-10506 on
      humoral immune response by measuring faecal sIgA and blood IgG, IgM, and IgA
    

Detailed description: 
      The type of the study is double blind randomize placebo-controlled trial with minimum 72
      subjects which divided into 2 groups i.e. 1) placebo group which will receive UHT milk (125
      mL) and 2) treatment group which will received UHT milk + paraprobiotic Lactobacillus
      plantarum IS-10506 5 x 1010 CFU/day (125 mL). The subjects have to consume one pack of milk
      every day for 90 consecutive days. Before and after intervention (day 30 and day 90), several
      data will be collected i.e. faecal sIgA, blood IgG, IgM, and IgA. The subjects recruited from
      elementary school in Yogyakarta District.
    

Intervention name(s): UHT Milk + Lactobacillus plantarum IS-10506; UHT Milk
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 125 ml UHT milk (+Lactobacillus plantarum IS-10506) given to treatment group; 125 ml UHT milk given to placebo group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other