bioihbjkbjnl/mcl2 huggingface dataset:
Comparative Clinical Trial to Evaluate Efficacy, Safety and Tolerance of BCD-054 and Avonex® for Treatment of Patients With Remitting-relapsing Multiple Sclerosis
Condition: Multiple Sclerosis, Relapsing-Remitting
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      An International Multicenter Double-blind Placebo-controlled Randomized Study to Compare the
      Efficacy, Safety and Tolerability of BCD-054 (JSC BIOCAD, Russia), 180 μg and 240 μg, versus
      Avonex® (Biogen Idec Ltd., UK) in Patients with Relapsing-remitting Multiple Sclerosis
    


Intervention name(s): BCD-054 180 mcg; Avonex®; BCD-054 240 mcg; Placebo
Intervention type(s): Biological; Biological; Biological; Other
Intervention description(s): 180 mcg intramuscularly once every two weeks; 30 mcg intramuscularly once a week; 240 mcg intramuscularly once every two weeks; intramuscularly once a week (0,5 ml)
Other intervention name(s): pegylated interferon beta-1a; interferon beta-1a; pegylated interferon beta-1a
Intervention MeSH terms: Interferons; Interferon-beta; Interferon beta-1a
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Glycemic and Insulinemic Impact of a Test Granola 3 Versus a Control Granola
Condition: Glycemic Response; Insulinemic Response; Subjectvie Hunger
Study type: Interventional

Summary: 
      The objectives of this study are to examine the blood glucose and serum insulin response
      elicited by servings of Test Granola and Control Granola containing equal amounts of
      available carbohydrate over a 3 h time period. In addition, the subjective hunger response to
      these foods will be measured over 3 h.
    


Intervention name(s): Test Granola; Control Granola
Intervention type(s): Other; Other
Intervention description(s): 51 g Test Granola; 54.1 Control Granola
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
A Study of Lazertinib (JNJ-73841937) Tablet in Healthy Adult Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the extent of availability of drug to the body of four
      different lazertinib tablet formulations at a single oral dose under fasted conditions in
      healthy adult participants.
    


Intervention name(s): Lazertinib
Intervention type(s): Drug
Intervention description(s): Lazertinib will be administered orally.
Other intervention name(s): JNJ-73841937
Intervention MeSH terms: Lazertinib
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Chronic Heart Failure - Cheyne Stokes Respiration - CS2 (3C-study)
Condition: Heart Failure; Cheyne Stokes Respiration
MeSH terms: Cheyne-Stokes Respiration; Heart Failure
Study type: Interventional

Summary: 
      An investigation where patients with chronic heart failure and cheyne stokes respiration,
      treated with adapitve servo ventilator, will improve their cardiac function and quality of
      life.
    

Detailed description: 
      Chronic heart failure (HF) is one of the most important public health problems in
      cardiovascular medicine.

      Several patients with chronic heart failure also has Cheyne Stokes respiration pattern.
      Earlier studies have shown that this respiration pattern improves with Adaptive servo
      ventilator. We wish to investigate wether this leads to improved cardiac function.
    

Intervention name(s): ASV; without Autoset CS2
Intervention type(s): Device; Other
Intervention description(s): Adaptive servo ventilator; without Autoset CS2
Other intervention name(s): AutoSet CS2
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: heart failure; cheyne stokes respiration; adaptive servo ventilator
Mepilex Ag Versus Silver Sulfadiazine in Children and Adults With Burn Injuries.
Condition: Burn Injuries
MeSH terms: Wounds and Injuries; Burns
Study type: Interventional

Summary: 
      The purpose is to compare time to healing using absorbent foam silver dressing (Mepilex Ag)
      compared to a silver sulfadiazine (SSD) 1% cream in the treatment of partial thickness burn
      injuries.284 in-patients in 8-12 centres in China will be evaluated. Treatment period will be
      up to 4 weeks with either Mepilex Ag or SSD.
    

Detailed description: 
      Subjects enrolled in this investigation were in-patients at eleven centers in China. To be
      included, subjects had to have deep partial-thickness burn injuries. The subjects were
      consecutively allocated to a subject code providing they fulfilled all inclusion criteria and
      none of the exclusion criteria and had signed a written informed consent form. Two evaluators
      independent of each other made the judgment regarding depth of the burn before enrolling a
      subject. The subjects were randomized to either receive Mepilex Ag or SSD.

      Treatment period were up to four weeks with either SSD or Mepilex Ag. Changes of the
      investigation products were performed according to a standardized schedule, unless the wound
      healed before.
    

Intervention name(s): Mepilex Ag; Silver Sulphadiazine Ag cream
Intervention type(s): Device; Drug
Intervention description(s): Dressing; A cream used on burnt areas.
Other intervention name(s): Absorbent foam silver dressing; SSD Ag cream, 1% SSD Ag, 40g/tube
Intervention MeSH terms: Sulfadiazine; Silver Sulfadiazine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Burn injuries; Mepilex Ag; SSD Ag; Partial thickness
Japan Phase 2/3 Clinical Study With BLM-240 (Desflurane)
Condition: Anesthesia
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purposes of this study are to evaluate the efficacy and safety of desflurane (BLM-240) as
      an anesthetic agent and to demonstrate the non-inferiority of desflurane to sevoflurane in
      term of awakening/recovery from anesthesia.
    

Detailed description: 
      The study evaluates the efficacy and safety of the use of desflurane (BLM-240) (with and
      without nitrous oxide) in maintenance of general anesthesia in adult patients undergoing
      surgical procedures typically performed under general anesthesia in Japan (thoracic,
      abdominal, joints, back, and neck), where analgesics and muscle relaxants are concomitantly
      used. The study is also intended to demonstrate the non-inferiority of desflurane with
      nitrous oxide to sevoflurane with nitrous oxide in time to awakening/recovery.
    

Intervention name(s): desflurane; desflurane/nitrous oxide; sevoflurane/nitrous oxide
Intervention type(s): Drug; Drug; Drug
Intervention description(s): volatile liquid for inhalation; volatile liquid for inhalation with gas for inhalation; volatile liquid for inhalation and gas for inhalation
Other intervention name(s): Suprane; BLM-240; Suprane; BLM-240; N2O; sevoflurane; N2O
Intervention MeSH terms: Nitrous Oxide; Sevoflurane; Desflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: anesthesia; desflurane
A Study Conducted in Healthy Subjects to Demonstrate Bioequivalence Between Ropinirole Prolonged Release Tablets Manufactured at Crawley and Aranda
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, randomised, two-period crossover, single dose study to demonstrate
      bioequivalence between the extended release 2 mg ropinirole XL tablets manufactured at two
      different sites in healthy subjects. Dosing will be under fasting conditions and there will
      be a minimum one week washout between doses. Domperidone will be administered to control
      dopaminergic side effects. Pharmacokinetic samples will be taken following each dose. Safety
      assessments will include screening and follow-up vital signs, ECGs and safety laboratory
      tests. Vital signs and adverse events will be monitored periodically throughout the study.
    

Detailed description: 
      This is an open-label, randomised, two-period crossover, single dose study to demonstrate
      bioequivalence between the extended release 2 mg ropinirole XL tablets manufactured at two
      different sites in healthy subjects. Dosing will be under fasting conditions and there will
      be a minimum one week washout between doses. Domperidone will be administered to control
      dopaminergic side effects. Pharmacokinetic samples will be taken following each dose. Safety
      assessments will include screening and follow-up vital signs, ECGs and safety laboratory
      tests. Vital signs and adverse events will be monitored periodically throughout the study.

      The manufacturing of ropinirole XL tablets will be moved from the Crawley (UK) manufacturing
      facility to the Aranda (Spain) manufacturing facility. The tablets manufactured at Aranda
      will have the same characteristics as those manufactured at Crawley.

      The present pharmacokinetic study is designed to assess bioequivalence of ropinirole XL 2 mg
      tablets manufactured at Aranda vs ropinirole XL 2 mg tablets manufactured at Crawley.
      Bioequivalence between the two tablets will be tested in healthy subjects and administered in
      the fasting state.
    

Intervention name(s): Ropinirole XL
Intervention type(s): Drug
Intervention description(s): Ropinirole XL manufactured at Crawley will be compared to that manufactued at Aranda.
Intervention MeSH terms: Ropinirole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Study of Danicopan in Participants of Japanese Descent
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics
      (PD) of danicopan after a single-dose oral administration under fed and fasting conditions to
      participants of Japanese descent.
    

Detailed description: 
      This will be an open-label, randomized, single-dose, 3-period, 3-treatment crossover study in
      participants of Japanese descent.

      On Day 1 of each period, participants will receive a single oral dose of 200 milligrams (mg)
      danicopan under fasting conditions, 200 mg danicopan under fed conditions, or 400 mg
      danicopan under fed conditions. Participants will receive each treatment once, according to
      the randomization schedule. There will be a washout period of at least 7 days between each
      dose of study intervention.

      Safety will be assessed throughout the study.
    

Intervention name(s): Danicopan
Intervention type(s): Drug
Intervention description(s): Oral tablet
Other intervention name(s): ALXN2040; ACH-0144471
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Three-way crossover
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Factor D inhibitor; Complement; Danicopan; Pharmacokinetics; Japanese; Food
Pilot Study Evaluating the Efficacy of Certolizumab Pegol for Interstitial Cystitis
Condition: Cystitis, Interstitial
MeSH terms: Cystitis; Cystitis, Interstitial
Study type: Interventional
Phase: Phase 3

Summary: 
      A Randomized, Double-blind, Placebo Controlled Trial of Certolizumab Pegol in Women with
      Refractory Interstitial Cystitis/Bladder Pain Syndrome
    

Detailed description: 
      Interstitial cystitis (IC) is a chronic disabling bladder syndrome characterized by urinary
      frequency, nocturia, urinary urgency, and pain or discomfort with bladder filling. There is
      no cure for IC and the treatment options are suboptimal. Patients with IC report significant
      negative effects on their physical and mental quality of life. The etiology of IC is unknown.
      Certain aspects of IC suggest that autoimmunity may play a role in initiating or sustaining
      the chronic inflammatory response. Bladder biopsies of patients with IC demonstrate an
      increase number of mast cells. Mast cell activation with the release of tumor necrosis factor
      (TNF) may mediate this bladder inflammation. Cimzia (certolizumab pegol) is a medication that
      blocks the effect of TNF. Cimzia (certolizumab pegol) is FDA approved for the treatment of
      rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and Crohn's disease. These
      diseases are similar to IC. In this study, the hypothesis being tested is that Cimzia
      (certolizumab pegol) will show efficacy in improving the symptoms of patients with IC.
    

Intervention name(s): Certolizumab pegol; Placebo
Intervention type(s): Biological; Drug
Intervention description(s): 400 mg; Normal saline
Other intervention name(s): Cimzia; Normal saline
Intervention MeSH terms: Certolizumab Pegol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Interstitial; Cystitis; Bladder; Pain
Safety and Tolerability of High Dose Biotin in Patients With Amyotrophic Lateral Sclerosis
Condition: Amyotrophic Lateral Sclerosis
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized double blinded randomized 2:1 study. The duration of the study is 6
      month. The safety and tolerability of high doses of biotin (300 mg/ day) will be compared to
      placebo in patients with amyotrophic lateral sclerosis. Patients will be evaluated at
      baseline, 3, and 6 month. The primary outcome will be any adverse effects recorded. The
      secondary outcomes will be motor disability measured by ALS-FRS, change in Pulmonary function
      test parameters (FEV1- FVC), change in subject weight (in kg).
    


Intervention name(s): Biotin; Placebo Oral Tablet
Intervention type(s): Drug; Drug
Intervention description(s): High dose biotin; Placebo tablet similar in shape and size to the biotin tablet
Other intervention name(s): vitamin B7; Placebo
Intervention MeSH terms: Biotin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective, double blind, placebo control, randomized 2:1 study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Amyotrophic lateral sclerosis; Biotin
Thrombophilia and Migraine, Are They Related?
Condition: Migraine; Thrombosis; Thrombophilia
MeSH terms: Migraine Disorders; Thrombosis; Thrombophilia
Study type: Observational

Summary: 
      Migraine was described as related to stroke in adults and children as well. Complete
      thrombophilic status was not study in large groups of pediatric patients. The purpose of our
      study is to assess the prethrombotic profile among children and teenagers diagnosed as
      suffering from migraine attacks.
    


Intervention name(s): Blood tests
Intervention type(s): Procedure
Observational model: Defined Population
Time perspective: Other
Keywords: Migraine; Thrombosis; Thrombophilia
Cervical Stabilization in Individuals With Obstructive Sleep Apnea
Condition: Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      This study will be performed in people with obstructive sleep apnea, in which one group will
      receive treatment with cervical stabilization for six weeks and the control group will
      receive treatment after the interval of six weeks
    

Detailed description: 
      The objective of this study was to evaluate the muscle strength of the cervical flexor and
      extensor muscles, to investigate the presence of cervical dysfunction and temporomandibular
      dysfunction, as well as to verify the effects of cervical stabilization in individuals with
      obstructive sleep apnea (OSA). The research will be carried out at the Orofacial Motricity
      Laboratory of the Federal University of Santa Maria (UFSM) and the University Hospital of
      Santa Maria (HUSM). Men and women between 20 and 60 years of age with a diagnosis of OSA will
      be invited to participate in this study, confirmed by polysomnography. The sample will
      consist of 22 patients with OSA, 11 subjects in the OSA group (OSA G) and 11 in the control
      group (CG) randomly. At the initial evaluation, an anamnesis will be performed and
      participants will respond to the Epworth Sleepiness Scale (ESS), Pittsburgh Sleep Quality
      Index (PSQI) and STOP-Bang questionnaire. The craniocervical posture will also be evaluated
      through photogrammetry (SAPo); The presence and severity of temporomandibular dysfunction
      (TMD) by the instruments Diagnostic Criteria in Research for Temporomandibular Dysfunction
      (RDC / TMD) and Temporomandibular Index (TMT); The presence of cervical dysfunction by the
      Craniocervical Dysfunction Index (CCID); The pressure pain threshold and the strength of the
      cervical flexor and extensor muscles, by pressure algometry and dynamometry, respectively.
      The OSA G will be submitted to cervical stabilization using the pressure biofeedback device
      (Stabilizer) and, after six weeks will be reassessed by the same questionnaires and
      instruments of the initial evaluation. The CG after six weeks will be reevaluated and the
      same treatment protocol will be offered.
    

Intervention name(s): Craniocervical flexion training
Intervention type(s): Device
Intervention description(s): The cervical stabilization will be performed with craniocervical flexion training with two weekly sessions for 6 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Physical Therapy Specialty
A Study to Evaluate the Safety and Immunogenicity of Quadrivalent Influenza Vaccine
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      This study aims to demonstrate the immunogenic efficacy of GC FLU Quadrivalent Pre-filled
      Syringe inj. (GC FLU), a quadrivalent influenza virus vaccine, is non-inferior to the active
      control, Fluarix Tetra. This study is designed to be a randomized, open-labelled,
      active-controlled, parallel, phase III study recruiting subjects from multiple study sites.

      Approximately 840 eligible subjects are planned to enroll in order to obtain 800 evaluable (=
      per-protocol) subjects. Subjects will be randomized and assigned to GC FLU or Fluarix Tetra
      (active control, AC) group in 1:1 ratio.
    


Intervention name(s): GC FLU Quadrivalent; Fluarix Tetra
Intervention type(s): Biological; Biological
Intervention description(s): A single dose administration of GC FLU Quadrivalent will be through intramuscular injection.; A single dose administration of Fluarix Tetra will be through intramuscular injection.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Characterization of Laboratory Response to DDAVP in Adult Hemophilia A Carriers
Condition: Hemophilia A
MeSH terms: Hemophilia A
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine how female hemophilia A carriers respond to a
      medication called DDAVP (Desmopressin).
    

Detailed description: 
      DDAVP (Desmopressin) is commonly used in the treatment of persons with bleeding disorders
      such as hemophilia, von Willebrand disease, or qualitative platelet disorders to help them
      clot better. The investigator wants to assess the increase in the subjects' clotting factors
      in response to intravenous DDAVP (Desmopressin) and the levels of these internal clotting
      factors will be measured at different times after the medication is given. The investigator
      will compare the response to DDAVP (Desmopressin) in adult hemophilia A carriers to women
      with a diagnosis of qualitative platelet dysfunction.
    

Intervention name(s): Desmopressin
Intervention type(s): Drug
Intervention description(s): Desmopressin or DDAVP will be administered intravenously (IV) via a nontraumatic peripheral IV line at a dose of 0.3 mcg/kg over 30 minutes.
Other intervention name(s): DDAVP
Intervention MeSH terms: Deamino Arginine Vasopressin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Factor VIII antigen; von Willebrand factor (vWF) antigen; Mutation type
A Study to Investigate Safety, Tolerability, and Pharmacokinetics of Oral Doses of TCK-276 in Patients With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is to evaluate the safety, tolerability, and pharmacokinetic (PK) of multiple
      orally administered TCK-276 in both males and females with Rheumatoid Arthritis (RA).
    

Detailed description: 
      This is a Phase 1, multi-center, double-blind, randomized, placebo-controlled, multiple
      ascending dose (MAD) study.

      The study will consist of a Screening Visit (Days -1 to Day 10), Treatment duration (up to 11
      days) and a Follow-up/end of treatment (EOT) visit.

      This MAD study will consist of 4 cohorts of 8 patients (6 active treatment and 2 matching
      placebo, or a 3:1 ratio), each receiving an oral dose of TCK-276 or matching placebo for 7
      days (once daily (QD) under fed condition). The first cohort will be divided into 2 subgroups
      to implement the sentinel dosing approach.

      The study duration is approximately 42 days.
    

Intervention name(s): TCK-276; TCK-276 Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Patients will receive an oral dose of TCK-276 (Dose A, B, C, and D) QD under fed conditions from Day 1 to Day 7.; Patients will receive an oral dose of TCK-276 matching placebo (Dose A, B, C, and D) QD under fed conditions from Day 1 to Day 7.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Multiple Ascending Dose; autoimmune disease; Disease modifying antirheumatic drugs (DMARD)
A Study of RBT-3 in Healthy Volunteers and Volunteers With Stage 3-4 Chronic Kidney Disease
Condition: Kidney Failure, Acute
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Acute Kidney Injury
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1b, single center, dose-escalating study evaluating the safety, tolerability,
      and pharmacodynamic effect of RBT-3 in healthy volunteers and in subjects with stage 3-4
      chronic kidney disease.
    


Intervention name(s): RBT-3
Intervention type(s): Drug
Intervention description(s): intravenous administration
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Prevention