bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy, Safety and Tolerability of Rotigotine Nasal Spray for the Acute Treatment of RLS Symptoms
Condition: Restless Legs Syndrome
MeSH terms: Psychomotor Agitation; Restless Legs Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      The main objective of this phase 2a proof-of-concept trial is to assess the efficacy of
      rotigotine nasal spray in ascending doses in subjects with idiopathic Restless Legs Syndrome.
    

Detailed description: 
      Each patient of the placebo and rotigotine group performed an Eligibility Assessment, as well
      4 treatment days at which subjects performed a repeated 'Suggested Immobilization Test' (SIT)
      during a 30min pre-dose and a 4 hours post-dose period. During these periods the severity of
      RLS symptoms in the legs was assessed by the subject using a numeric symptom severity scale.

      In addition the leg movements were measured by actigraphy to assess the Periodic Leg Movement
      Index during Wakefulness (PLMWI, PLM per hour). Subjects applied a single dose of treatment
      on each treatment day (placebo nasal spray or rotigotine nasal spray in 3 ascending doses).
    

Intervention name(s): Rotigotine Nasal Spray; Placebo Nasal Spray
Intervention type(s): Drug; Other
Intervention description(s): Daily single dose of 62µg, 124µg, and 247µg rotigotine delivered as single puff of nasal spray solution; Daily single dose of placebo delivered as single puff of nasal spray solution
Other intervention name(s): SPM937
Intervention MeSH terms: Rotigotine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Rotigotine; Rotigotine nasal spray; Efficacy, safety and tolerability; Restless Legs Syndrome
Let's Get Organized Feasibility Study
Condition: Neurodevelopmental Disorders; Mental Disorder
MeSH terms: Mental Disorders; Neurodevelopmental Disorders
Study type: Interventional

Summary: 
      The aim of this study is to pilot test the Let's Get Organized (LGO) Occupational Therapy
      intervention in a Swedish context by exploring possible enhancements in time management
      skills, aspects of executive functioning, and satisfaction with daily occupations in persons
      with time-management difficulties due to neurodevelopmental and/or mental disorders.

      Method:

      A pre-post design with 3 and 12-months follow-up is used.

      The LGO intervention is a manual-based group intervention aiming to enhance time-management,
      targeted to persons with mental or neurodevelopmental disorders. The LGO is conducted as 10
      weekly 1.5-hour group sessions. Two trained group leaders, lead each group of 6-8
      participants. Goal-directed and other learning strategies are used to train effective time
      management habits such as maintaining a calendar and wearing a watch. All group sessions
      follow the same format, and each session has a set theme. Group sessions are structured with
      a slide presentation and a course manual, and information from the group leaders is
      intermixed with discussion among the participants and tasks to complete.

      The primary outcome of the study is self-reported time management measured by the Assessment
      of Time Management Skills (ATMS-S). Secondary outcomes are executive functioning measured
      with the Weekly Calendar Planning Activity (WCPA) and satisfaction with daily occupations,
      which is measured with the interview-administered questionnaire Satisfaction with Daily
      Occupations 13 items (SDO-13).

      Data will be collected before intervention start (pre intervention), after intervention
      completion (post intervention) and 3 and 12 months post intervention completion. The ATMS
      will be collected at all four time points. The WCPA and SDO-13 will be collected pre, post
      and 12 months post intervention.
    


Intervention name(s): Let's Get Organized
Intervention type(s): Behavioral
Intervention description(s): Group intervention aiming to enhance time-management, targeted to persons with mental or neurodevelopment disorders. Each group has 6-8 participants and is lead by two trained group leaders. Goal-directed and other learning strategies are used to train effective time management habits such as maintaining a calendar and wearing a watch. Group sessions are structured with a PowerPoint presentation and a course manual, and information from the group leaders is intermixed with discussion among the participants and tasks to complete.
Other intervention name(s): LGO
Intervention model: Single Group Assignment
Intervention model description: Pre-post intervention study
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Time management; Group intervention; Executive function
The Effects of Vitamin B-6 and Coenzyme Q10 Status on Oxidative Stress, Antioxidant Capacities, and Inflammatory Responses in Patients With Liver Cancer
Condition: Hepatocellular Carcinoma.
MeSH terms: Carcinoma, Hepatocellular
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Carcinoma is the leading cause of worldwide. Hepatocellular carcinoma (HCC) is the second
      cause of cancer mortality in Taiwan. Vitamin B-6 and coenzyme Q10 has been recognized as
      antioxidants and anti-inflammatory nutrients in recent clinical studies. The purposes of this
      study are going to investigate the relation of vitamin B-6 and coenzyme Q10 with the
      indicators of oxidative stress, antioxidant enzymes activities and the inflammatory markers
      in patients with stage 1 and stage 2 HCC. The study is designed as an intervention study. The
      investigators will recruit HCC patients with stage 1 and stage 2 (n = 150) who are identified
      by liver biopsy. HCC subjects are randomly assign to placebo, vitamin B-6 (50 mg/d), coenzyme
      Q10 (300 mg/d), and vitamin B-6 plus coenzyme Q10 supplements groups. Intervention is going
      to administration for three months. The concentrations of vitamin B-6, coenzyme Q10,
      oxidative stress indicators, antioxidant enzymes activities, antioxidant vitamins (vitamin A
      and E), and inflammatory markers are going to be analyzed. The results would provide more
      information nutrients for clinical physicians and dietitians for considering suggesting
      patients with HCC using vitamin B-6 or coenzyme Q10 supplementation to improve their clinical
      outcomes.
    


Intervention name(s): Vitamin B-6; Coenzyme Q10; Vitamin B-6+Coenzyme Q10; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Other
Intervention description(s): Vitamin B-6 50 mg/d; Coenzyme Q10 300 mg; Vitamin B-6 (50 mg/d) and Coenzyme Q10 (300 mg/d); starch
Intervention MeSH terms: Vitamins; Coenzyme Q10; Vitamin B 6; Pyridoxal; Pyridoxine; Vitamin B Complex; Ubiquinone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
A Study to Compare the Uptake Into the Blood of Two Strengths of Somapacitan After Injection Under the Skin in Healthy Subjects
Condition: Healthy Volunteers; Growth Hormone Deficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will compare two strengths of the new long-acting growth hormone somapacitan. The
      aim of this study is to test if both strengths are taken up in the blood in the same way.
      During three separate dosing visits participants will get a total of 3 injections of the
      study medicine. Somapacitan is not yet approved and therefore cannot be prescribed by a
      doctor outside of this study. The study duration is between 10 and 15 weeks. Participants
      will have 17 visits with the study doctor. Three visits will each comprise 6 in-house days
      with overnight stays. In total, at least 15 overnight stays at the clinic. There will be
      blood samplings during the study. Participants must come to the clinic regularly for these
      blood samplings. People who have already received growth hormones in the past or who are
      growth hormone deficient cannot be in the study. People cannot be in the study if the study
      doctor thinks that there are risks for their health. Women cannot take part if pregnant,
      breast-feeding or planning to become pregnant during the study period.
    


Intervention name(s): somapacitan
Intervention type(s): Drug
Intervention description(s): 5 mg/1.5 ml and 10 mg/1.5 ml doses administered s.c. (subcutaneously, under the skin)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Lenalidomide With or Without Rituximab in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
Condition: Leukemia
MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Biological therapies such as lenalidomide use different ways to stimulate the
      immune system and stop cancer cells from growing. Monoclonal antibodies such as rituximab can
      locate cancer cells and either kill them or deliver cancer-killing substances to them without
      harming normal cells. Combining lenalidomide with rituximab may kill more cancer cells.

      PURPOSE: This phase II trial is studying the how well giving lenalidomide with or without
      rituximab works in treating patients with relapsed or refractory chronic lymphocytic
      leukemia.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the best cytostatic response rate (including complete response, partial
           response, or stable disease) in patients with relapsed or refractory chronic lymphocytic
           leukemia treated with lenalidomide (CC-5013).

      Secondary

        -  Determine the cytostatic response rate in patients who progress on CC-5013 and are then
           treated with CC-5013 and rituximab.

        -  Determine the safety of these regimens in these patients.

        -  Determine time to progression in patients treated with these regimens.

      OUTLINE: This is an open-label, non-randomized, pilot study.

      Patients receive oral lenalidomide (CC-5013) once daily on days 1-21. Treatment repeats every
      28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
      Patients who achieve complete response (CR) receive 2 additional courses beyond CR.

      Patients with disease progression receive oral CC-5013 once daily on days 1-21 and rituximab
      IV on days 1, 8, and 15 during the first treatment course and on days 1 and 15 of all
      subsequent courses. Treatment repeats every 28 days for up to 6 courses in the absence of
      further disease progression. Patients who achieve CR receive 2 additional courses beyond CR.

      Patients are followed at 1 month and then every 3 months thereafter.

      PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study within 1.5 years.
    

Intervention name(s): rituximab; lenalidomide
Intervention type(s): Biological; Drug
Intervention description(s): IV; Oral
Intervention MeSH terms: Rituximab; Lenalidomide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: refractory chronic lymphocytic leukemia
Mouthwash of Pomegranate Against Biofilm and Gingival Inflammation in School Children
Condition: Gingivitis
MeSH terms: Gingivitis
Study type: Interventional

Summary: 
      The mechanical control of supragingival biofilm is accepted as one of the most important
      measures to prevent dental caries and periodontal diseases. Nevertheless, maintaining dental
      surfaces biofilm-free is not an easy task. In this regard, numerous studies researches have
      demonstrated the effectiveness of mouthwashes containing antimicrobial active ingredients
      that prevent and control both supragingival biofilm and gingivitis, specially when used
      adjunctively to mechanical oral hygiene regimens.
    

Detailed description: 
      In vitro and clinical researches using Punica granatum Linn shows antimicrobial and
      antiadherent activity against dental biofilm microorganisms. The purpose of this study was to
      evaluate the clinical effectiveness of a mouthwash of Punica granatum Linn. against biofilm
      and gingival inflammation in school children
    

Intervention name(s): Punica granatum Linn.; chlorhexidine
Intervention type(s): Drug; Drug
Intervention description(s): Mouthwash (6,25% of Punica granatum Linn) 10mL per day during 14 days; standard anti-bacterial mouthwash Mouthwash (0,12% chlorhexidine) 10mL per day during 14 days
Other intervention name(s): Pomegranate; Periogard
Intervention MeSH terms: Chlorhexidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: DENTAL PLAQUE; MEDICINAL PLANTS; GINGIVITIS
Comparison of Two Vaginal Tablets, Produced at Different Sites, in Postmenopausal Women With Atrophic Vaginitis
Condition: Menopause; Postmenopausal Vaginal Atrophy
MeSH terms: Atrophy
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of this trial is to compare the absorption of
      estradiol after a single dose of two 25 mcg estradiol vaginal tablets, produced at two
      different production sites, in postmenopausal women with atrophic vaginitis.
    


Intervention name(s): estradiol, 25 mcg; estradiol, 25 mcg
Intervention type(s): Drug; Drug
Intervention description(s): Single dose of vaginal tablet containing 25 mcg estradiol (Production site A) followed by another single dose of vaginal tablet containing 25 mcg estradiol (Production site B); Single dose of vaginal tablet containing 25 mcg estradiol (Production site B) followed by another single dose of vaginal tablet containing 25 mcg estradiol (Production site A)
Intervention MeSH terms: Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol; Polyestradiol phosphate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Exercise Training on Left Ventricular Function in Type 2 Diabetic Patients Post Coronary Artery Bypass Graft
Condition: Diabetes Mellitus, Non-Insulin-Dependent; Coronary Arteriosclerosis; Post Coronary Artery Bypass Grafting
MeSH terms: Arteriosclerosis; Coronary Artery Disease; Myocardial Ischemia; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the changes of cardiorespiratory fitness and left
      ventricular function in type 2 diabetes after uncomplicated coronary artery bypass graft
      (CABG) surgery.

      We hypothesize that exercise capacity, left ventricular diastolic function, and biochemical
      data improves after 12-wk exercise training in patients with type 2 diabetes underwent CABG.
    

Detailed description: 
      Patients with type 2 diabetes mellitus have higher incidence of coronary artery disease or
      left ventricular dysfunction, particularly diastolic dysfunction. Coronary artery bypass
      surgery is known to decrease the mortality rate in diabetes. Further exercise training can
      improve their cardiorespiratory fitness and the control of risk factors in these patients.
      However, the extent of improvement and the mechanism, especially the changes in left
      ventricular function, in diabetes after exercise training have not been fully explored.

      Subjects will be assigned to the intervention or control group by randomization. Subjects in
      the intervention group will receive 60% VO2 max moderate aerobic exercise training, twice per
      week under supervision and three times per week at home, for 12 weeks. All subjects receive
      left ventricular function test by echocardiography and impedance cardiography, graded maximal
      exercise test, and biochemical analyses of sugar and lipid before and after 12 weeks. Their
      dietary intake and physical activity will be inquired every 4 weeks by questionnaires.
    

Intervention name(s): Exercise training; Control
Intervention type(s): Behavioral; Other
Intervention description(s): Subjects attended a supervised treadmill training session three times per week in an outpatient facility for three months. Training duration was 30 minutes per session, including a 5-minute warm-up and cool-down phase. Training intensity was initially set at about 60% of HR reserve and close to the anerobic threshold (AT) and the gradually increased as tolerated.; Subjects received general education including proper diet, regular physical activity or medical care if necessary through an interview with a physical therapist.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Bioequivalence Study of Cetirizine Hydrochloride 10mg Tablets Under Fed Conditions
Condition: Healthy
MeSH terms: Disease
Study type: Interventional

Summary: 
      An open label, randomized, single-center, single-dose, two-treatment, two-period, crossover
      bioavailability study comparing Cetirizine Hydrochloride 10 mg tablet of Ohm Laboratories
      Inc. (A subsidiary of Ranbaxy, Inc) with Zyrtec® Cetirizine Hydrochloride, 10 mg tablet of
      Pfizer Labs (Division of Pfizer Inc.) in healthy, adult, human subjects under fed condition
    

Detailed description: 
      The study was conducted as an open label, randomized, single-center, single-dose,
      two-treatment, two-period, crossover bioavailability of the test formulation of cetirizine
      hydrochloride tablet of Ohm Laboratories Inc. (A subsidiary of Ranbaxy, Inc) containing 10 mg
      cetirizine hydrochloride study comparing to the marketed product, Zyrtec®, containing 10 mg
      of cetirizine hydrochloride of Pfizer Labs (Division of Pfizer Inc.), in healthy, adult,
      human, subjects under fed condition.

      Safety measures were performed throughout the study and included a physical examination,
      laboratory evaluation, and measurement of vital signs.

      A total of 32 subjects were randomized to receive single oral dose of cetirizine
      hydrochloride 10 mg tablet and 29 subjects completed both the periods of the study.
    

Intervention name(s): Cetirizine Hydrochloride 10 mg tablet
Intervention type(s): Drug
Intervention description(s): Bioequivalence Cetirizine Hydrochloride 10 mg tablet fed conditions
Intervention MeSH terms: Cetirizine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Bioequivalence Cetirizine Hydrochloride 10 mg tablet fed conditions
A Study to Learn How the Study Medicine Called Sisunatovir is Tolerated and Acts in the Bodies of Chinese Healthy Adults.
Condition: Respiratory Syncytial Virus Infection
MeSH terms: Respiratory Syncytial Virus Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to learn about:

        -  The activity of sisunotavir in the body over a period. It includes the processes by
           which sisunotavir is absorbed, distributed in the body, localized in the tissues, and
           removed from the body.

        -  safety and tolerability of sisunatovir (PF-07923568) in Chinese healthy adult
           participants.

      This information is being collected to support further clinical development as well as
      medicine registration in China.

      This study is seeking for participants who:

        -  are male and female participants aged 18 to 65 years of age.

        -  are male and female participants who are healthy as seen by medical tests.

        -  have body mass index (BMI) of 19 to 27 kg/m2 and a total body weight of more than 50
           kilograms (110 pounds).

      About 12 participants will receive sisunatovir. Four capsules (strength=50 milligrams, 200
      milligrams in total) of Sisunatovir will be given on Day 1 on empty stomach. This will be
      followed by 8 capsules of sisunatovir with 12 hours gap in between four capsules from Days 4
      to 7. The participants will have to take 4 capsules of sisunatovir in the morning of 8th day
      with a meal.

      The total time of participants will be in the study is about 71 days. This includes the
      screening visit to the Follow-up contact. In screening visit, participants will be tested to
      see if they are fit to take part in the study.
    


Intervention name(s): Sisunatovir
Intervention type(s): Drug
Intervention description(s): Will be given as a single dose on Day 1 in a fasted state followed by repeated twice daily doses (200 mg BID, Q12 hours) from Days 4-7 plus 1 morning dose on Day 8 in a fed state
Intervention model: Single Group Assignment
Intervention model description: single-arm to investigate PK, safety and tolerability of 200 mg sisunatovir given as a single dose on Day 1 in a fasted state followed by repeated twice daily doses (200 mg BID, Q12 hours) from Days 4-7 plus 1 morning dose on Day 8 in a fed state in Chinese healthy participants.
Masking: None (Open Label)
Primary purpose: Other
Evaluate the Efficacy of the OITcontrol Application.
Condition: Food Allergy in Children
MeSH terms: Food Hypersensitivity
Study type: Interventional

Summary: 
      The main aim of this study is to evaluate the clinical efficacy of the OITcontrol application
      in patients undergoing OIT of eggs or milk used during the follow-up of this treatment.
    

Detailed description: 
      1. Evaluate the quality of life of patients with respect to their food allergy by analyzing
           the data from the FAQLQ-CF and/or SFAQoL-PF questionnaires.

        2. Evaluate the perception of patients on the quality and safety of hospital care through
           the analysis of the adapted SERVQHOS questionnaire and the "Evolution of the perception
           of patients on the safety of health services".

        3. Evaluate patient safety with OITcontrol based on:

             1. Number of reactions in the hospital,

             2. Number of reactions outside the hospital,

             3. Compliance with the information and recommendations by the patient:

           i. recording shots, ii. reaction log, iii. discordances between the medication used and
           prescribed after a reaction, iv. avoidance of cofactors.

        4. Evaluate the consumption of health resources regarding the use, derived from the OIT of
           the following resources:

             1. Number of extraordinary visits to the allergy department,

             2. Number of phone calls for questions,

             3. Number of visits to the emergency department.
    

Intervention name(s): OITcontrol app monitoring
Intervention type(s): Device
Intervention description(s): App to monitor OIT patients
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research