bioihbjkbjnl/mcl2 huggingface dataset:
A Study of LY3473329 in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study in healthy participants is to learn more about the safety of
      LY3473329 and any side effects that might be associated with it. Blood tests will be
      performed to check how much LY3473329 gets into the bloodstream and how long the body takes
      to eliminate it. This is a two-part study. Participants may only enroll in one part.

      For each participant:

        -  Part A will last up to about 19 weeks and may include 9 visits.

        -  Part B will last up to about 28 weeks and may include 11 visits.
    


Intervention name(s): LY3473329; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered orally.; Administered orally.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Small Intestinal Bacterial Overgrowth Obese
Condition: Gastric Bypass; Blind Loop Syndrome; Bacterial Overgrowth Syndrome; Chromatography, Gas
MeSH terms: Blind Loop Syndrome; Syndrome
Study type: Interventional

Summary: 
      The objective of this research is to determine the incidence of microbial overgrowth of the
      small intestine before and after a gastric bypass. For this purpose, the study is based on
      the analysis of the expired hydrogen H2 with gas chromatography before surgery and at 1, 3,
      6, 12, 18 and 24 months.
    


Intervention name(s): gas chromatography; Stool analysis for detection of malabsorption
Intervention type(s): Procedure; Procedure
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Gastric bypass; Intestinal Bacterial Overgrowth Syndrome; Gas chromatography
Bioequivalence Study of Divalproex Sodium Capsules(Sprinkle),125 mg of Dr. Reddy's Under Fasting Condition (Apple Sauce)
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose,
      crossover, bioequivalence study of Divalproex Sodium coated particles in capsules 125 mg with
      Depakote® Sprinkle125 mg capsules in healthy, adult, human subjects under fasting conditions.
    

Detailed description: 
      An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose,
      crossover, bioequivalence study of Divalproex Sodium Capsules (Sprinkle), 125 mg of
      Dr.Reddy's Laboratories Limited,comparing with that of Depakote® Sprinkle 125 mg capsules of
      Abbott Laboratories, USA in healthy, adult, human subjects under fasting conditions with an
      adequate washout period of 10 days.

      The subjects were given a single oral dose of medication (test study or reference medication)
      . The capsule was opened and all the contents were sprinkled over a spoonful of applesauce
      without a spillage and administered to the subjects.
    

Intervention name(s): Divalproex Sodium
Intervention type(s): Drug
Intervention description(s): Divalproex Sodium Coated Particles in Capsules, 125 mg of Dr. Reddy's Laboratories Limited
Other intervention name(s): Depakote Sprinkle
Intervention MeSH terms: Valproic Acid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Randomized, Multiple Dose, Double Blind, 5-way Crossover Study of the Electrocardiographic (ECG) Effects of Bilastine
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effect of two doses of bilastine (20 and 100 mg)
      compared to bilastine 20 mg administered with ketoconazole 400 mg, moxifloxacin 400 mg, and
      placebo. Subjects will receive each of the five study treatments in a crossover fashion
      administered once daily for 4 days.
    

Detailed description: 
      This is a single center, Phase 1 study that utilizes a randomized, multiple-dose,
      double-blind, 5-way crossover design with a placebo control and two active controls. A
      minimum seven day washout period following four days of dosing for each of the five
      treatments.
    

Intervention name(s): bilastine; Bilastine; Bilastine & Ketoconazole; Moxifloxacin; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 20 mg tablets.; 100 mg (5 tablets of 20 mg); 1 capsule containing bilastine 20 mg tablet + ketoconazole 400 mg tablet; 1 capsule containing moxifloxacin 400 mg tablet; Placebo tablets
Intervention MeSH terms: Moxifloxacin; Ketoconazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Allergic rhinitis; Urticaria
Cryoablation of AF: Improving the Use of the Achieve Catheter
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Observational

Summary: 
      According to data from high volume Centres, documentation of entry block with the Achieve
      catheter may be possible in only about to 50% of pulmonary veins. The investigators aim to
      assess strategies using the Achieve catheter that can improve this performance.
    


Intervention name(s): Maneuvers for documenting the disconnection
Intervention type(s): Other
Other intervention name(s): type 1; type 2; type 3; type 4
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Consecutive patients undergoing cryoablation of atrial fibrillation using the Achieve
        catheter to document pulmonary vein disconnection.
      
Keywords: atrial fibrillation; balloon cryoablation; pulmonary veins
Pharmacokinetics of LCQ908 in Patients With Renal Impairment
Condition: Renal Impairment
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will compare the pharmacokinetics of LCQ908 in subjects with varying degrees of
      renal impairment to healthy subjects
    


Intervention name(s): LCQ908
Intervention type(s): Drug
Intervention description(s): Participants will receive a single oral dose of LCQ908
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: LCQ908, Renal Impairment, Pharmacokinetics
A Study of Inhaled Atropine Sulfate in Healthy Adults
Condition: Organophosphorus Poisoning
MeSH terms: Poisoning; Organophosphate Poisoning
Study type: Interventional
Phase: Phase 1

Summary: 
      MicroDose Defense Products, LLC is developing an atropine dry powder inhaler (ADPI). This
      pilot study compares the pharmacokinetics (PK) of inhaled dry powder atropine as delivered by
      the ADPI to atropine delivery from the AtroPen autoinjector.
    


Intervention name(s): atropine sulfate; atropine sulfate
Intervention type(s): Drug; Drug
Intervention description(s): dry powder for inhalation; intramuscular injection
Other intervention name(s): MicroDose inhaler
Intervention MeSH terms: Atropine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Atropine; Aerosol; Inhaler; Dry Powder
Clearblue Advanced Fertility Monitor Consumer One Cycle at Home Study
Condition: Pregnancy
Study type: Interventional

Summary: 
      This study will assess the use of the new Clearblue Advanced Fertility Monitor for one
      menstrual cycle in a home setting by female volunteers seeking to get pregnant.
    

Detailed description: 
      The Clearblue Fertility Monitor is a personal monitor designed to be used with disposable
      test sticks for the semi-quantitative measurement of estrone-3-glucuronide (E3G) and
      luteinising hormone (LH) in women's urine. This personal information allows women to identify
      their fertile window and appropriately time intercourse in order to maximise their chances of
      conception. A new version of this monitor (Clearblue Advanced Fertility Monitor) has been
      developed with additional functionality including the option to test for pregnancy.

      This study will assess the volunteer ease of use of the new Clearblue Advanced Fertility
      Monitor and the understanding and interpretation of the results by the user. This is a single
      centre clinical study which will be conducted by volunteers at their residence and
      co-ordinated by the clinical department at SPD Development Company Ltd.

      A minimum of 100 female volunteers representing the target consumer will be required to use
      the new Clearblue Advanced Fertility Monitor at home as per the instructions for use. This
      will involve them setting up the monitor, using the monitor for one full cycle and then
      setting up the monitor for their next cycle unless they test for pregnancy and get a pregnant
      result.

      At the end of one full cycle, all volunteers will complete a study questionnaire which
      includes sections on comprehension of the instructions for use, ease of use and
      interpretation of test results.
    

Intervention name(s): Clearblue Advanced Fertility Monitor
Intervention type(s): Device
Intervention description(s): Clearblue Advanced Fertility Monitor used for one menstrual cycle in a home setting
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Pregnancy
Small Bowel Microbiota Characterization in Healthy Individuals Before and After Consumption of a Western Diet
Condition: Small Intestine Bacteria
Study type: Interventional

Summary: 
      Does the small bowel microbiota in healthy individuals change after consumption of a Western
      diet?
    

Detailed description: 
      The gut microbiota is increasingly being implicated in disease. However, due to difficulty
      accessing the small bowel (i.e. requiring upper endoscopy) and the relative paucity of
      bacteria in this area (secondary to luminal flow and bactericidal bile acids/gastric acid),
      the small bowel microbiota is infrequently evaluated in any studies of this nature. The small
      bowel microbiota continues to remain an unexplored area of the gastrointestinal tract.
      Characterization of the microbial community and its function is the first step in determining
      how it potentially affects health and disease.
    

Intervention name(s): Western diet
Intervention type(s): Behavioral
Intervention description(s): Western diet for 7 days: the meals in this Western diet will be provided by the Clinical Research and Trials Unit (CRTU) after participants meet with the nutrition staff (to discuss food preferences, how to obtain the meals). The meals will reflect a typical Western diet: a low fiber, high sugar diet with weight maintenance calories with < 10 grams fiber per day, and a typical US macronutrient calorie distribution of 50% carbs, 35% fat and 15% protein, with no alcohol. At least 50% of carbohydrates will be provided as simple sugars.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Gut microbiota
Tele-Rehabilitation in Individuals With Covid-19
Condition: COVID-19
MeSH terms: COVID-19
Study type: Interventional

Summary: 
      Coronavirus Disease (COVID-19) is a respiratory disease caused by severe acute respiratory
      syndrome coronavirus 2 (SARS-cov-2). This study was planned as a single-blind randomized
      controlled pilot study to compare the effectiveness of telerehabilitation-based exercise
      training applied to individuals with Covid-19. Individuals will be divided into two groups,
      the control group and the study group. All assessments will be made online twice, before and
      after treatment. Socio-demographic data of individuals who agreed to participate in the
      study, disease information about Covid-19, MRC Dyspnea Scale, COVID-19 Fear Scale,
      International Physical Activity Questionnaire-Short Form, ST. George Respiratory
      Questionnaire, Fatigue Severity Scale, Nottingham Health Profile will be questioned and
      recorded. The obtained data will be analyzed with statistical methods.
    


Intervention name(s): Exercise
Intervention type(s): Other
Intervention description(s): Home-based physical activity programs are very important to strengthen the immune system, which is extremely important in the fight against COVID-19 infection, and to protect physical and mental health. In addition, since the pulmonary rehabilitation sessions carry a high risk of transmission, it is recommended that the program be carried out with applications such as single-session training, tele-rehabilitation or home program. Although the home pulmonary rehabilitation program is adapted to the individual, it generally includes positioning, mobilization, relaxation exercises, respiratory training, respiratory muscle exercises, upper and lower extremity exercises, walking, climbing stairs and cycling exercises. The general opinion is that telerehabilitation practices have many benefits such as increasing the quality of life and physical activity. In addition to these benefits, telerehabilitation applications come to the fore in the Covid-19 period with its complementary feature.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Covid-19; Breathing; Quality of Life; Physical Activity; Fatigue
Inhibitory Effect of Propofol on Perineal Pruritus in Patients Undergoing Day Surgery
Condition: Pruritus Vulvae
MeSH terms: Pruritus Vulvae; Pruritus
Study type: Interventional

Summary: 
      OBJECTIVE: To investigate the inhibitory effect of different doses of propofol on perineal
      pruritus induced by dexamethasone sodium phosphate injection in women, with a view to
      providing clinical reference for comfortable clinical care in day surgery.

      METHODS: One hundred and fifty patients with ASA classification I or II undergoing elective
      day surgery were randomly divided into six groups of P1, P2, P3, P4, P5 and D1, with 25 cases
      in each group. Before administration of dexamethasone, propofol injection 0.1 mg/kg, 0.2
      mg/kg, 0.3 mg/kg, 0.4 mg/kg and 0.5 mg/kg were given intravenously in groups P1, P2, P3, P4
      and P5, respectively (injection rate was 5 s), followed by 30 s of intravenous dexamethasone
      sodium phosphate 10 mg in all five groups; 5 ml of saline was given in group D1, and 30 s
      After that, dexamethasone sodium phosphate injection was given (injection speed was 5s in all
      five groups). The perineal itching, the onset and duration of itching, the visual analogue
      score (VAS) of itching, the sleep disorder sedation score (Ramsay score) and the occurrence
      of adverse reactions were recorded in the five groups.
    


Intervention name(s): Propofol
Intervention type(s): Drug
Intervention description(s): 0.1mg/kg, 0.2mg/kg, 0.3mg/kg, 0.4mg, kg, 0.5mg/kg Propofol was injected to five groups of P1, P2, P3, P4 and P5, respectively, and 5mg dexamethasone sodium phosphate was given to groups P1, P2, P3, P4, P5 and D1 after 30s
Intervention MeSH terms: Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
The Effects of Elmore Oil on Patients With Osteoarthritis
Condition: Degenerative Arthritis; Inflammation
MeSH terms: Arthritis; Osteoarthritis; Inflammation
Study type: Observational

Summary: 
      The treatment of osteoarthritis, a disease that eventually affects the majority of the older
      population, involves the alleviation of symptoms such as pain and stiffness, and the
      reduction of inflammation. A double-blind, placebo-controlled, crossover study will be
      performed to examine the effect of topical application of Elmore Oil, a herbal remedy
      (containing Eucalyptus oil, Tea tree oil, Olive oil and Vanilla), which has recently been
      reported to have anti-inflammatory properties, on the symptoms of osteoarthritis.
    

Detailed description: 
      Sixty patients were randomly selected and approved for the study, 30 patients with even
      numbers received the blue dotted Elmore oil and 30 patients with odd numbers got the orange
      dotted Elmore and were advised to apply 3x daily on the affected knees respectively for four
      weeks. On the fifth week, they stopped application for 7 days as flush out period. Then on
      the 6th week a cross over was done on the patients - the blue dotted patients, this time
      received the orange dotted Elmore Oil and vice-versa and did the application three times
      daily for another 4 weeks. All throughout the usage, they filled out their diaries (noting
      the degree of pain, feeling of well being (improved sleep, mobility, ability to do their
      daily activities at home or at work). A pre-application base line laboratory tests were done,
      after 4 weeks and after 8 weeks.
    

Intervention name(s): Two oily solutions (Blue Dotted and Orange Dotted Elmore Oils)
Intervention type(s): Other
Intervention description(s): Thirty participants received Blue Dotted Elmore Oil and another thirty received the Orange dotted Elmore Oil, they applied the oils three times daily on the affected knees for four weeks and stopped usage on the fifth week (flush out period) and on the 6 week, the two group switched to Orange and Blue Elmore Oil respectively. All throughout applications, they filled out their diaries to indicate changes in their mobility, moods, feeling of well being and ability to do their daily work at home or at work every week.
Other intervention name(s): Oily solution in a bottle containing olive oil, tea tree oil, vanilla and eucalyptus.; Another oily solution in a bottle containing olive oil.
Intervention MeSH terms: Tea Tree Oil; Pharmaceutical Solutions
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Population from which the cohorts will be selected are from hospital primary care arthritis
        clinic.
      
Keywords: Osteoarthritis; Osteoarthritic pain; Arthritic pain; Arthritis; joint inflammation; Arthralgia
Evaluation of the Bone Mineral Density and Muscle Mass in Patients Post Coronary Artery Bypass Graft Surgery With Chronic Kidney Disease
Condition: Coronary Artery Bypass Graft; Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Observational

Summary: 
      The purposes of this study are: (1) to compare the body composition, physical activity,
      physical function, and quality of life between patients with and without CKD after CABG; and
      (2) to analyze the relationships among body composition, physical activity, and physical
      function in this population. It is expected that patients after CABG with CKD have the worse
      body composition, physical function, and quality of life than patients after CABG without
      CKD; and patients with higher physical activity levels have the better body composition,
      physical function, and quality of life.
    

Detailed description: 
      It has been reported that cardiac disease and renal disease frequently coexisted. Recently,
      the term cardiorenal syndrome was used to describe the interaction between heart and kidney.
      Chronic kidney disease (CKD) has become increasingly recognized as an independent risk factor
      of cardiovascular disease, and the cardiovascular disease is one of most severe complication
      in patients with CKD. Previous studies have showed the changes in body composition, physical
      inactivity, decreased physical function, and poor quality of life existed in patients with
      either cardiovascular disease or CKD. Patients concomitant with cardiovascular disease and
      kidney insufficiency were expected to significantly increase physical dysfunction. However,
      few studies addressed on these alterations in patients after coronary artery bypass grafting
      (CABG) with CKD were reported.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        All patients who underwent CABG at the Department of Cardiovascular Center at Far-Eastern
        Memorial Hospital since January 2000 were selected for recruitment to this study.Thirty
        male patients after CABG with CKD and 30 matched controls were recruited (ages between
        40-75 years old).
      
Keywords: Coronary artery bypass grafting; Chronic kidney disease; Body composition; Physical activity; Physical function
Effects Of Additional MgSO4 30 Mg/KgBW Intravenous and Ketorolac
Condition: Anesthesia; Pain, Postoperative; Surgery; Opioid Use
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      This study aims to compare two groups of post-orthopedic patients who received a standard
      regimen, namely ketorolac 30mg, to the second group, which was given the standard regimen and
      adjuvant magnesium sulfate 30mg/kgBW 1 hour preoperatively. If it is proven useful, it is
      hoped that pain will be more controlled, reduce pain complications, reduce treatment costs,
      and reduce the duration of hospital stays.
    

Detailed description: 
      The study design used was a randomized controlled trial (RCT) with double blinds. Double
      blind because neither the patient, the lead investigator, nor the investigator on record knew
      the drug or placebo that was administered. Research subjects were selected consecutively in
      patients who will undergo lower extremity surgery at the Cipto Mangunkusumo National Central
      General Hospital. Forty-eight research subjects will be divided into two groups, namely the
      group given Intravenous Magnesium Sulfate 30 mg/kgBW and the group given a placebo. Research
      subjects were randomized by type of surgery using randomization software by research
      assistants. The results of randomization were not known to the patient, the principal
      investigator, or the researcher taking notes.

      This study aims to determine the effect of adding 30 mg/kg body weight of intravenous MgSO4
      to 30 mg of ketorolac on the degree of pain and the need for opioids after lower extremity
      surgery.
    

Intervention name(s): MgSO4
Intervention type(s): Drug
Intervention description(s): The treatment group who received intravenous magnesium sulfate therapy with 20% magnesium sulfate regimen, 30mg/kg body weight dissolved in 100ml NaCl in 1 hour intravenously
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment