bioihbjkbjnl/mcl2 huggingface dataset:
Kuvan®'s Effect on the Cognition of Children With Phenylketonuria
Condition: Phenylketonuria
MeSH terms: Phenylketonurias
Study type: Interventional
Phase: Phase 4

Summary: 
      The study is a single-cohort, interventional, open-label trial to evaluate long-term
      neurocognitive (NC) outcomes in children aged 4 to 5 years with phenylketonuria (PKU) treated
      with Kuvan® and Phenylalanine-restricted diet over a period of 7 years.
    


Intervention name(s): Kuvan®
Intervention type(s): Drug
Intervention description(s): Kuvan® oral soluble tablet will be administered once daily along with Phenylalanine-restricted diet for a period of 7 years. Dosage of Kuvan® could range from 5 to 20 milligram per kilogram per day (mg/kg/day), as per Summary of Product Characteristics (SPC).
Other intervention name(s): Sapropterin dihydrochloride
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Phenylketonuria; Kuvan; Sapropterin dihydrochloride
A Microneurography (MNG) Study of VX-150 in Healthy Participants
Condition: Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine if C fiber conduction is impacted by NAV1.8
      modulation.
    

Detailed description: 
      This clinical trial information was submitted voluntarily under the applicable law and,
      therefore, certain submission deadlines may not apply. (That is, clinical trial information
      for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public
      Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by
      sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).
    

Intervention name(s): Placebo; VX-150
Intervention type(s): Drug; Drug
Intervention description(s): Placebo matched to VX-150 for oral administration.; Solution or Suspension for oral administration.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Safety and Efficacy of Cariprazine in Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study is to evaluate the efficacy, safety, and tolerability of
      cariprazine relative to placebo for the treatment of acute exacerbation of schizophrenia.
    


Intervention name(s): Cariprazine; Aripiprazole; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Patients who meet eligibility criteria will be administered a once daily oral dose of cariprazine for six weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period.; Patients who meet eligibility criteria will be administered a once daily oral dose of aripiprazole for six weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period.; Patients who meet eligibility criteria will be administered a once daily oral dose of placebo for six weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period.
Other intervention name(s): RGH-188
Intervention MeSH terms: Aripiprazole; Cariprazine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Schizophrenia; Acute Schizophrenia; Psychotropic Drugs; Aripiprazole; Antipsychotic Agents; Mental Disorders; Dopamine Agents; Central Nervous System Agents
Evaluation of Sit-to-stand Test in Patients With Cystic Fibrosis and Matched Controls.
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Observational

Summary: 
      Introduction: In recent years, since the discovery of the cystic fibrosis (CF) transmembrane
      conductance regulator gene in human skeletal muscle, there appears to be growing interest in
      the measurement of muscle function in CF. One of the most used test in other chronic
      pulmonary diseases is the Sit-to-Stand test (STS) which consists of simply getting up from a
      chair. Although the main result of the STS test is the time developed during the task, the
      velocity and power generated during the task are considered very important variables to
      detect the functional decline. However, from our knowledge, no study has previously analyzed
      the differences in time, velocity and muscle power developed during the STS test in patients
      with CF and their respective healthy controls.

      Objectives: To compare the values gained from handgrip strength, walking speed and STS test
      (time, velocity, and muscle power) in a group of patients with CF and their respective
      healthy controls, and to analyze if these differences (if any) are associated with lung
      function in patients with CF.

      Methods: Cross-sectional study with a sample of 60 participants (30 patients diagnosed with
      CF and 30 healthy subjects) between 18-65 years old. The STS test will be measured through
      slow-motion video recording with a smartphone device (240 images per second) which will
      report the time, velocity and power generated during the test. Walking speed and handgrip
      strength will be also measured. Additionally, the relationship between the variables obtained
      during the test and the lung function of patients with CF will be analized.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients with cystic fibrosis will be recruited from the Cystic Fibrosis Association of
        Murcia, Spain. Additionally, a non-probabilistic sample from healthy subjects will be
        enrolled.
      
Keywords: Cystic Fibrosis; Sit-to-stand; Lung Function; Handgrip; Walking Speed; Power; Velocity; Gait Speed; Chair rise
Treatment for Specific Phobias in Children
Condition: Phobic Disorders; Anxiety Disorders
MeSH terms: Anxiety Disorders; Phobic Disorders
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study will compare the effectiveness of three treatments in reducing symptoms of phobia
      in children and adolescents.
    

Detailed description: 
      Children with specific phobias may experience academic, social, and personal distress, as
      well as interference in day-to-day activities. One-Session Treatment has been found a rapid
      and effective treatment for adults with phobic disorders. However, its utility in the
      treatment of childhood phobia has not been examined.

      Participants are randomly assigned to 1 of 3 groups: a one-session treatment group, an
      education/support group, and a waitlist control group. The one-session treatment group is
      directly exposed to a phobia object or situation during a 3-hour treatment session. In the
      education/support group, children are given information about fear and phobias and are taught
      how to deal with them through workbook activities. Children who participate in the
      one-session treatment group or the education/support group are assessed 1 week post-treatment
      and again after 6 months. Participants with improved symptoms have a 1-year follow-up.
      Participants with phobias that persist at 6 months are encouraged to participate in
      alternative treatment. Waitlist control participants are assessed pre-treatment and 1 month
      post-treatment. Those who continue to have phobias at the 1-month assessment are randomly
      assigned to 1 of the 2 active treatments.
    

Intervention name(s): One-Session Treatment for Specific Phobias
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Escalating Doses of PM01183 in Combination With Gemcitabine in Patients With Specific Unresectable Solid Tumors
Condition: Specific Advanced Solid Tumors
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      Phase I multicenter, open-label, clinical and pharmacokinetic study of PM01183 in combination
      with gemcitabine in non-heavily pretreated patients with selected advanced solid tumors to
      determine the maximum tolerated dose (MTD) and the recommended dose (RD) of PM01183 in
      combination with gemcitabine, to characterize the safety profile and feasibility of this
      combination in patients with selected advanced solid tumors, to characterize the
      pharmacokinetics (PK), to obtain preliminary information on the clinical antitumor activity
      in non-heavily pretreated selected solid tumor patients and to evaluate the pharmacogenomics
      (PGx) in tumor samples of patients exposed, in order to assess potential markers of response
      and/or resistance.
    


Intervention name(s): lurbinectedin (PM01183); Gemcitabine
Intervention type(s): Drug; Drug
Intervention description(s): lurbinectedin (PM01183) is presented as powder for concentrate for solution for infusion with two strengths, 1-mg and 4-mg vials; 1000 mg vial, powder for injectable solution
Intervention MeSH terms: Gemcitabine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: lurbinectedin; PM01183; tumors; cancer; Pharma Mar
Study of Efficacy and Safety of Canakinumab in Japanese Patients With SJIA
Condition: Systemic Juvenile Idiopathic Arthritis
MeSH terms: Arthritis; Arthritis, Juvenile
Study type: Interventional
Phase: Phase 3

Summary: 
      This was a phase III study designed to provide efficacy and safety data for canakinumab
      administered for at least 48 weeks as subcutaneous (s.c.) injection every 4 weeks (q4wk) in
      Japanese patients with Systemic Juvenile Idiopathic Arthritis (SJIA). Interim analysis (IA)
      data at Week 28 and 48 from this study supported a registration submission of canakinumab in
      the indication of SJIA in Japan.
    


Intervention name(s): Canakinumab
Intervention type(s): Biological
Intervention description(s): canakinumab was provided as a 150 mg/1 mL solution for subcutaneous injection and administered at 4mg/kg every 4 weeks.
Other intervention name(s): ACZ885
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ACZ885; canakinumab; Juvenile Rheumatoid arthritis (JRA) chronic; systemic inflammatory disorder; painful joints; inflammation of the synovial membrane; auto-immune rheumatoid disease; reactive rheumatoid arthritis; Systemic Juvenile Rheumatoid arthritis (SJRA); Japanese patients
A Personalized Diet Study to Reduce Glycemic Exposure
Condition: Pre-diabetes; Overweight and Obesity
MeSH terms: Overweight; Prediabetic State
Study type: Interventional

Summary: 
      The aim of this 2-phase, randomized clinical trial will be to examine the effects of two
      behavioral weight loss interventions on weight loss. This study will be conducted in 200
      overweight or obese prediabetic individuals recruited from community-based settings.. Phase 1
      will include 6-months of active intervention. Phase 2 will consist of 6-months of maintenance
      and observation. Measurements will occur at screening, baseline, 3, 6, and 12 months.
      Participants will be randomized with equal allocation to 2 groups: (1) a standardized
      behavioral weight loss intervention with a one-size-fits-all regimen that includes counseling
      about restriction of calories and calories from fat, and physical activity, delivered using
      mHealth technology, or (2) all of the elements of mHealth, plus personalized dietary
      recommendations to minimize glycemic response to meals. Participants will be required to
      attend 6 separate visits over both phases of the study.
    


Intervention name(s): mHealth; Personalized mHealth
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Behavioral weight loss intervention using behavioral counseling focusing on physical activity and a one-size-fits-all, calorie-restricted, diet.; Behavioral weight loss intervention with personalized dietary recommendations based on machine learning algorithm that integrates gut microbiota, dietary intake, physical activity and various blood parameters to predict postprandial glycemic response.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Grass Sensitisation and Allergic Rhinitis in Thai Patients
Condition: Allergy to Grass Pollen; Allergic Rhinitis Due to Weed Pollens
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Observational

Summary: 
      Allergic rhinitis patients are the patients who have nasal symptoms when triggered by indoor
      or outdoor allergens. Outdoor allergen can be divided into grass, tree, or weed. The type of
      grass or weed are different in various part of the world. The allergens from grass and weed
      has never been studied in Thailand. This study will find the major allergen from Bermuda
      grass, Johnson grass, Para grass, sedge, and ragweed, which are very common in Thailand. In
      addition, the investigators will study about the cross-reactivity among these group of
      allergen.
    

Detailed description: 
      To find the major allergen of grass and weed, the serum of patients will be used to bind with
      the allergen extract by immunoblot study.

      The ELISA-inhibition will be used to study about cross-reactivity among various kinds of
      grass and weed.
    

Intervention name(s): Immunoblot
Intervention type(s): Other
Intervention description(s): serum specific IgE binds to grass extract by immunoblot
Sampling method: Non-Probability Sample
Study population: 
        Allergy Clinic
      
Biospecimen description: 
      Serum
    
Keywords: Grass; Major allergen; cross-reactivity
Clinical Study Investigating the Conversion of the Contraceptive Compound Norethisterone Within the Body Towards the Contraceptive Compound Ethinylestradiol
Condition: Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      The clinical phase I study aims at investigating the conversion of the contraceptive compound
      norethisterone within the body towards the contraceptive compound ethinylestradiol. Therefore
      concentrations of ethinylestradiol will be measured from blood samples after administration
      of a single intramuscular dose of norethisterone. In a comparison arm concentrations of
      ethinylestradiol will be measured from blood samples after administration of a pill
      containing ethinylestradiol itself.
    


Intervention name(s): Microgynon; Noristerat(BAY86-6308)
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will receive 21 daily oral doses of Microgynon tablets containing 0.15 mg levonorgestrel und 0.03 mg ethinylestradiol.; Subjects will receive one intramuscular dose of Noristerat (oily solution for intramuscular injection) containing 200 mg norethisterone enantate.
Intervention MeSH terms: Ethinyl estradiol, levonorgestrel drug combination; Ethinyl Estradiol-Norgestrel Combination
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Drug Kinetics
Improving Mobility in Diabetic Patients Through Resistance Training
Condition: Diabetic Patients With Polyneuropathy
MeSH terms: Polyneuropathies
Study type: Interventional

Summary: 
      Impaired mobility is a major health problem affecting many subjects with diabetes mellitus.
      It is associated with loss of quality of life and it is a strong predictor for poor health
      outcomes. Reduced lower extremity muscle function, as a consequence of diabetic
      polyneuropathy, is a major cause of impaired mobility. We hypothesize that a programme of
      resistance training will counterbalance the effects of polyneuropathy on muscle wasting, and
      will improve mobility and associated quality of life.

      The objective of this study is to develop a resistance training intervention that improves
      mobility and quality of life in diabetic patients. It is also our intension to achieve a
      better understanding of the relation between diabetic neuropathy and muscle weakness, limited
      mobility and quality of life. Moreover, insight will be gained in optimizing training
      programmes for neuropathic patients.
    


Intervention name(s): resistance training
Intervention type(s): Other
Intervention description(s): During 24 weeks, the patients of the intervention group will participate in a resistance training program. Two subsequent intervention programmes will be offered. Initially the first 12 week resistance trainings stage will aimed at improving function of lower leg muscles; subsequently a more extended programme affecting total limb musculature (lower- and upper leg) will be provided (also 12 weeks).
During these trainings period, patients will train 3 times a week; once a plenary training session of 1,5 hour provided by a physical therapist. And 2 trainings sessions of half an hour each, by them selves at home.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Muscle strength; Physical activity; Mobility; Gait analysis
Use of Intrathecal Analgesia in Appendectomy
Condition: Anesthesia; Analgesia
MeSH terms: Agnosia
Study type: Interventional

Summary: 
      Acute appendicitis which is the most common cause of acute abdominal pain, is an acute
      inflammation of appendix vermiformis. Appendectomy operations can be performed as
      laparoscopic and open surgery. Addition of opioids to intrathecal local anesthetics to
      improve the quality of preoperative analgesia is an increasingly used method in recent years.
      The aim of this study is to compare bupivacaine-fentanyl and bupivacaine-alfentanil which are
      used intrathecally to create motor and sensory block. 50 volunteer patients who were
      diagnosed as appendicitis by laboratory tests and clinical diagnostic methods in general
      surgery clinic and classified as American Society of Anesthesiologists Classification I-II
      (ASA Class I-II) aged between 20-60 years scheduled for laparoscopic appendectomy operation,
      were included in this study. The patients were randomly assigned into two groups, Group I and
      Group II. Patients received spinal anesthesia with either 10 mg heavy bupivacaine (2 cc)+25
      mcg fentanyl (0.5 cc) intrathecally (Group I, n=25) or 10 mg heavy bupivacaine (2 cc)+250 mcg
      alfentanil (0.5 cc) intrathecally (Group II, n=25).
    


Intervention name(s): 25 mcg fentanyl; 250 mcg alfentanil
Intervention type(s): Drug; Drug
Intervention description(s): Before operation each patient was informed about the use of patient controlled analgesia system and visual pain scale (VPS) for pain scoring. In operating room all patient was monitored using electrocardiography (ECG), noninvasive blood pressure. Before spinal anesthesia 10-15 ml/kg intravenous serum saline infusion was started. Group I received 10 mg hyperbaric bupivacaine (2 cc) and 25 mcg fentanyl (0.5 cc).; Before operation each patient was informed about the use of patient controlled analgesia system and visual pain scale (VPS) for pain scoring. In operating room all patient was monitored using electrocardiography (ECG), noninvasive blood pressure. Before spinal anesthesia 10-15 ml/kg intravenous serum saline infusion was started. Group II received 10 mg hyperbaric bupivacaine (2 cc) and 250 mcg alfentanil (0.5 cc) intrathecally.
Other intervention name(s): fentanyl; alfentanil
Intervention MeSH terms: Fentanyl; Alfentanil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: intrathecally fentanyl; alfentanil; visual pain scale; analgesia
Study of Efficacy and Safety of Ginger Extract Compared With Loratadine for Treatment of Allergic Rhinitis
Condition: Rhinitis,Allergic
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 2

Summary: 
      Efficacy and adverse effects of Ginger extract in treating allergic rhinitis patients
      compared with Loratadine.The double blind randomized controlled trial study was approved by
      the Human Research Ethics Committee of Thammasat University NO.1.
    

Detailed description: 
      The double blind randomized controlled trial study. Patients who meet the inclusion criteria
      and do not fall into any exclusion criteria will be randomly placed into the experimental
      group, who will receive ginger extract capsules, or the control group, who will receive
      loratadine for 42 days.
    

Intervention name(s): Ginger extract; Loratadine
Intervention type(s): Drug; Drug
Intervention description(s): Ginger extract capsule at dose of 250 mg two times a day after meal daily for 42 days; Loratadine tablet at dose of 10 mg one times a day after morning meal daily for 42 days
Other intervention name(s): Clarityne
Intervention MeSH terms: Loratadine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The URT and Middle Ear Microbiota in Health and During Chronic OME
Condition: Otitis Media With Effusion; Healthy
MeSH terms: Otitis; Otitis Media; Otitis Media with Effusion
Study type: Observational

Summary: 
      This study analyses which bacteria are present in the middle ear space and adjacent upper
      respiratory tract niches in healthy people and in patients suffering from chronic otitis
      media with effusion (OME; glue ear). The aim is to identify and isolate bacteria that are
      more common and more abundant in healthy people and to evaluate their potential to protect
      against bacteria commonly involved in OME and other upper respiratory tract infections.

      To this end, samples will be collected from both groups (healthy vs OME) and analysed through
      sequencing of the bacterial 16S gene. In addition, samples obtained from healthy participants
      will be cultivated to isolate bacteria of interest.
    


Intervention name(s): Collection of body fluids/swabs
Intervention type(s): Other
Intervention description(s): Middle ear, ear duct, anterior nare, nasopharynx, adenoids. Niches depend on accessibility for each individual participant.
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        100 healthy participants vs 100 OME patients.
      
Biospecimen description: 
      Samples with extracted DNA (extraction kit targets bacterial DNA) Original samples in
      glycerol (100 µL) of otitis media patients (for potential future isolation of otitis media
      associated bacteria)
    
Keywords: OME; Otitis Media with Effusion; Microbiota; Microbiome; URT; Upper Respiratory Tract; Healthy URT microbiota