bioihbjkbjnl/mcl2 huggingface dataset:
Gelesis200 Safety and Tolerability Study and Effects on Glycemic and Appetite Parameters
Condition: Healthy Overweight Obese
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The purpose of this study is to determine the safety and tolerability of Gelesis200.
    

Detailed description: 
      This is a cross-over within parallel design. Parallel groups will receive Gelesis200 either 2
      times or 3 times in one day before meals. Within the parallel groups, subjects will
      cross-over to 4 arms: A) Gelesis200 10 min before meals, B) Gelesis200 30 min before meals,
      C) Placebo 10 min before meals, D) Placebo 30 min before meals. Postprandial glucose, insulin
      and subjective appetite ratings will also be measured.
    

Intervention name(s): Gelesis200; Placebo
Intervention type(s): Device; Other
Intervention description(s): 3 capsules each containing 0.70 g; 3 capsules each containing 0.57 g of a mixture of microcrystalline cellulose and maltodextrin in a ratio of approximately 50 ± 10%
Other intervention name(s): maltodextrin/microcrystalline cellulose
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study to Characterize the Absorption, Metabolism, and Excretion of 14C-JNJ-53718678 After a Single Oral Dose in Healthy Male Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to determine the routes of excretion for JNJ-53718678 and its
      metabolites, to explore the metabolic pathways of JNJ-53718678, and to determine the chemical
      structure of predominant metabolites in healthy adult male participants after a single oral
      dose of 500 milligram (mg) 14C-JNJ-53718678.
    


Intervention name(s): JNJ-53718678
Intervention type(s): Drug
Intervention description(s): Participants will receive a single 500 milligram (mg) dose of 14C-JNJ-53718678 as an oral liquid solution containing 14C-labeled and unlabeled JNJ-53718678 corresponding to a radioactivity dose.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study on the Influence of Forest Therapy on Healing Experience in Botanical Gardens.
Condition: Nature, Human
Study type: Interventional

Summary: 
      The forest healing system is an important topic of alternative therapy in recent years. To
      study the influence of Forest therapy, the establishment of a pilot experimental model system
      in which both environmental factors and type of activity are necessary. Therefore, a system
      based on the Taipei Botanical Garden was introduced by this study.
    

Detailed description: 
      The forest healing system is an important topic of alternative therapy in recent years.
      Forest therapy began in 1989 when the psychology professor Kaplan put forward the "Attention
      Restoration Theory(ART)". Awareness has a positive benefit. To study the influence of Forest
      therapy, the establishment of a pilot experimental model system in which both environmental
      factors and type of activity are controlled can greatly reduce the errors caused by the site
      and the content of the activity. Therefore, a randomized controlled crossover experiment
      based on the Taipei Botanical Garden was introduced by this study.
    

Intervention name(s): activities in the Botanical Garden or in urban
Intervention type(s): Behavioral
Intervention description(s): activities in the Taipei Botanical Garden or in Urban
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Forest therapy
Effects of Liraglutide on the Cognitive Function in Patients With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      Type 2 diabetes mellitus (T2DM) can impaire cognitive function,the prevalence of Alzheimer's
      Disease(AD) in T2DM patients is 1.5 to 2.5 times higher than the general population.Cognitive
      impairment seriously affects the health and quality of life of the elderly. Prevention and
      treatment measures for cognitive decline in persons with T2DM has not been well studied.

      Glucagon-like peptide-1 (GLP-1) is a member of an endogenous class of incretin hormones
      synthesized in intestinal epithelial L-cells.GLP-1 enhances glucose-dependent secretion of
      insulin,inhibits glucagon secretion, slows gastric emptying and reduces food intake.
      Liraglutide is a glucagon-like peptide type 1 (GLP-1) analogue. It has been proved that
      Liraglutide can improve insulin resistance and cognitive function in AD animals. Therefore,
      it is speculated that Liraglutide may interfere with the occurrence and development of
      cognitive dysfunction in patients with T2DM. In order to confirm the effects, the
      investigators conduct an open, prospective, positive controlled study in patients with T2DM.
      The effect on BMI,waist circumference, hip circumference, waist-to-hip ratio,fasting plasma
      glucose，glycosylated hemoglobin,blood lipids and cognitive function were measured to explore
      the effects of liraglutide in patients with T2DM.

      The overall goal of this study is to explore the effects of liraglutide on the cognitive
      function in patients with type 2 diabetes mellitus and make further contribution to the
      improvement of cognitive function.
    


Intervention name(s): Liraglutide; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Liraglutide is a glucagon-like peptide type 1 (GLP-1) analogue. It has been proved that Liraglutide can improve insulin resistance and cognitive function in AD animals. Therefore, it is speculated that Liraglutide may interfere with the occurrence and development of cognitive dysfunction in patients with T2DM. In order to confirm the effects, the investigators conduct an open, prospective, positive controlled study in patients with T2DM.; Any hypoglycemic drugs except glucagon-like peptide type 1 (GLP-1) analogue.
Intervention MeSH terms: Liraglutide
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type 2 diabetes mellitus; Cognitive function; Liraglutide
Relating Retinal Structural and Functional Parameters to Visual Acuity in Eyes Undergoing Treatment for Diabetic Macular Edema
Condition: Diabetic Macular Edema
MeSH terms: Macular Edema; Edema
Study type: Observational

Summary: 
      This longitudinal interventional case series will utilize the patients at the University of
      Michigan W.K. Kellogg Eye Center scheduled to begin treatment for diabetic macular edema.
      Baseline measures will be taken which include structural assessments such as circulatory
      capacity utilizing fluorescein angiography, in addition to retinal layer integrity and
      thickness using high resolution optical coherence tomography. Also, functional assessments
      such as visual acuity, contrast sensitivity, photostress recovery, dark adaptation,
      perimetry, and cellular fluorescence will be tested. Adverse events will be recorded and
      compared with historical controls to ensure that currently accepted interventions are safe.
      Finally, potential confounding variables for DME including those related to the eye, systemic
      factors, and patient demographics will be recorded to assess the influence of these variables
      on treatment response.

      The primary objective is to develop hypotheses that might better explain the retinal
      structural (anatomical) and/or functional (physiological) mechanisms of visual impairment in
      eyes receiving treatment for diabetic macular edema (DME).
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Individuals undergoing treatment for diabetic macular edema at the University of Michigan
        W.K. Kellogg Eye Center.
      
Keywords: Diabetic Macular Edema
Evaluation of the Efficacy and Safety of Diclofenac HPBCD 25, 50 mg/ml in the Treatment of Post-surgical Pain Following Dental Surgery
Condition: Dental Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 3

Summary: 
      The present study is proposed to evaluate the efficacy and safety of single doses of
      Diclofenac HPBCD subcutaneous (s.c.) (25 mg/1 ml and 50 mg/1 ml) in the treatment of acute
      moderate-to-severe pain after dental impaction surgery.
    


Intervention name(s): Diclofenac HPBCD; Diclofenac HPBCD; Diclofenac HPBCD; Placebo s.c.
Intervention type(s): Drug; Drug; Drug; Other
Intervention description(s): 1 single injection at day of dental surgical extraction; 1 single injection at day of dental surgical extraction; 1 single injection at day of dental surgical extraction; 1 single injection at day of dental surgical extraction
Intervention MeSH terms: Diclofenac
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Bioavailability Study of Fluconazole Tablets 200 mg Under Fed Conditions
Condition: Healthy
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study was an open-label, randomized, 2-way crossover to compare the
      single-dose relative bioavailability of Dr. Reddy's Laboratories, Ltd. and Pfizer (Diflucan®)
      200 mg fluconazole tablets under fed conditions.
    

Detailed description: 
      Detailed Description : The study was conducted as an open-label, randomized, single-dose,
      2-way crossover, relative bioavailability study performed on 16 healthy adult male
      volunteers. A total 15 subjects completed the clinical phase of the study. In each period,
      subjects were housed from the mornings dosing until after the 72-hour blood draw. Single oral
      200 mg doses were separated by a washout period of 21 days.
    

Intervention name(s): Fluconazole; Fluconazole
Intervention type(s): Drug; Drug
Intervention description(s): Fluconazole Tablets, 200 mg; fluconazole 200 mg
Other intervention name(s): Dr. Reddy's Laboratories; Diflucan (Pfizer)
Intervention MeSH terms: Fluconazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioequivalence; Fluconazole; Crossover
Lesinurad and Febuxostat Combination Extension Study in Gout
Condition: Gout
MeSH terms: Gout
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will assess the serum uric acid lowering effects and safety of lesinurad in
      combination with febuxostat over a long-term timeframe.
    

Detailed description: 
      This is a Phase 3 extension study to assess the long-term efficacy and safety of lesinurad in
      combination with febuxostat in subjects who completed the double-blind treatment period in
      Study RDEA594-304.
    

Intervention name(s): lesinurad; lesinurad; febuxostat
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Tablets, 400 mg once daily (QD); Tablets, 200 mg QD; Tabletsm 80 mg QD
Intervention MeSH terms: Febuxostat; Lesinurad
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Gout
Study of Effects of Preoperative Oral Domperidone on Gastric Residual Volume After Clear Fluid Ingestion in Patients Scheduled for Elective Surgeries
Condition: Gastric Residual Volume
Study type: Interventional
Phase: Phase 3

Summary: 
      General Anesthesia requires preoperative fasting according to specific instructions.
      Regarding Fasting Guidelines, The American Society of Anesthesiologists (ASA) recommends
      patients to fast from fatty food or meat eight hours prior to surgery, non-human milk or
      light meal for six hours prior, breast milk for four hours prior, and clear liquids including
      water, pulp-free juice, and tea without milk for two hours prior to the anesthetic. ASA
      fasting guidelines application represents the primary method to avoid aspiration as it
      ensures that stomach is empty before induction of anesthesia. These guidelines cannot be
      applied on all cases as in urgent or emergent situations or in morbidities associated with
      delayed gastric emptying, like Diabetes mellitus and some neurological disorders (
    


Intervention name(s): Domperidone; Folic acid
Intervention type(s): Drug; Drug
Intervention description(s): ultrasound guieded assesment of gastric residual volume will be done 2 h after oral injestion of domperidone tablet; ultrasound guieded assesment of gastric residual volume will be done 2 h after oral injestion of folic acid tablet
Intervention MeSH terms: Folic Acid; Domperidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
HRQoL and Function of Adults Treated in Adolescence for Scoliosis With Physical Exercises
Condition: Scoliosis
MeSH terms: Scoliosis
Study type: Observational

Summary: 
      We attempt to investigate the influence of physiotherapy and physical activity education
      applied in adolescence on physical fitness, curve progression, pulmonary function, physical
      activity and quality of life in adulthood. Quality of life assessment includes mental and
      social functioning, body image, self - esteem, depression and anxiety surveillance. The
      follow - up period ranges from 15 to 26 years. Also a group of shorter follow - up of 9 - 13
      years is available.

      The null hypothesis is that scoliosis specific exercise program applied in adolescence does
      not influence HRQoL and functioning in adulthood.
    

Detailed description: 
      Among conservative treatment approaches of adolescent idiopathic scoliosis (AIS), different
      physiotherapy methods are recommended and popular in some countries (Spain, Germany, Poland),
      while in others bracing and observation are standard (North America, Australia, the UK,
      Scandinavia. Neither of the methods have been shown to be definitely effective. Considerable
      evidence indicates that bracing can lead to psychological stress, poorer body image and self
      - esteem and reduce overall quality of life in adulthood. As to physiotherapy and physical
      exercises, such evidence is limited, especially long term follow up studies are not
      available.
    

Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Treatment group (retrospection - medical records) - patients diagnosed and / or treated in
        the Centre of Corrective and Compensatory Gymnastics in Bielsko - Biala, Poland, between
        1983 and 1994. Diagnosis: idiopathic scoliosis (IS) - adolescent idiopathic scoliosis (AIS)
        or early onset idiopathic scoliosis (EOIS) A comparison (control) group: patients with IS,
        age - and condition - matched, who were diagnosed at the same time, in the same clinic, and
        by the same physician, and prescribed the same method of physiotherapy, but did not start
        the exercise treatment.
      
Keywords: scoliosis; physical therapy; long term outcome; pulmonary function; physical fitness; health related quality of life; psychopathology
Comparison of Lung Deposition With the Aeroneb Solo Adapter and a Standard Jet Nebulizer by SPECT-CT
Condition: Healthy
Study type: Interventional

Summary: 
      Aeroneb Solo Adapter is a vibrating-mesh nebulizer Aeroneb Solo combined to a spacer
      specifically designed for spontaneously breathing patients. This device has not been
      investigated in vivo yet.

      It's known that using a spacer during nebulization improves aerosol delivery. We hypothetized
      that lung deposition could be highly increased with the Aeroneb Solo Adapter in comparison to
      a standard jet nebulizer.
    


Intervention name(s): Technetium-99m - Diethylenetriaminepentaacetic acid; Aeroneb Solo Adapter; Opti-Mist Plus Nebulizer; Planar scintigraphy; Single photon emission computed tomography; Spirometry
Intervention type(s): Drug; Device; Device; Other; Other; Other
Intervention description(s): Solution placed on the nebulizer reservoir; Nebulizer; Standard jet nebulizer; Imaging technique to investigate whole lung deposition; Imaging technique to investigate regional pulmonary deposition; FEV1, FVC assessment
Intervention MeSH terms: Edetic Acid; Pentetic Acid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Aerosol delivery; Lung deposition; SPECT; subjects
Functional Outcomes of a Criterion-based Rehabilitation Protocol for ACL Reconstruction in Amateur Athlete
Condition: Knee Ligament Injury; Anterior Cruciate Ligament Injuries
MeSH terms: Wounds and Injuries; Anterior Cruciate Ligament Injuries
Study type: Interventional

Summary: 
      Although current rehabilitation protocols following anterior cruciate ligament reconstruction
      (ACLR) are based on the graft remodeling process, there is uncertainty about its time
      schedule. Moreover, there are individual differences in neuromotor learning and flexibility
      after ACLR. This study was conducted to investigate the effect of a criterion-based
      rehabilitation protocol on pain intensity, effusion, and knee function in amateur athletes
      following ACLR.

      Although current rehabilitation protocols following anterior cruciate ligament reconstruction
      (ACLR) are based on the graft remodeling process, there is uncertainty about its time
      schedule. Moreover, there are individual differences in neuromotor learning and flexibility
      after ACLR. This study was conducted to investigate the effect of a criterion-based
      rehabilitation protocol on pain intensity, effusion, and knee function in amateur athletes
      following ACLR.
    


Intervention name(s): rehabilitation protocol
Intervention type(s): Other
Intervention description(s): Current conventional protocols were based mainly on biological tissue healing time frames. These protocols emphasize pain reduction, full passive knee extension, quadriceps strength training, immediate motion, immediate par¬tial weight bearing (only if there is a correct gait pattern without any complications), and functional exercises The criterion-based rehabilitation protocol is relatively new. It was developed and recommended in 2016 by the Royal Dutch Society for Physical Therapy (KNGF), aiming to assure a more patient-tailored rehabilitation and to maximize the speed of a patient's progress. It's a three phases protocol with a criterion-based progression.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study to Evaluate the Safety, Tolerability, Immunogenicity and Vaccine-like Viral Shedding of MEDI-534, Against Respiratory Syncytial Virus (RSV) and Parainfluenza Virus Type 3 (PIV3), in Healthy 6 to <24 Month-old Children and in 2 Month-old Infants
Condition: Healthy
MeSH terms: Paramyxoviridae Infections
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Primary objective of this study is to describe the safety and tolerability of multiple doses
      of MEDI-534 in children 6 to less than (<) 24 months of age and in infants 2 months of age.
    

Detailed description: 
      This is a Phase 1/2a, randomized, double-blind, placebo-controlled, dose-escalation,
      multicenter study to evaluate the safety and tolerability of multiple doses of MEDI-534 at
      10^5 or 10^6 median tissue culture infectious dose (TCID50) in RSV and PIV3 seronegative
      children 6 to <24 months of age and at dosages of 10^4, 10^5 or 10^6 TCID50 in unscreened
      infants 2 months of age.
    

Intervention name(s): MEDI-534, Cohort 1; Placebo, Cohort 1; MEDI-534, Cohort 2; Placebo, Cohort 2; MEDI-534, Cohort 3; Placebo, Cohort 3; MEDI-534, Cohort 4; Placebo, Cohort 4; MEDI-534, Cohort 5; Placebo, Cohort 5
Intervention type(s): Biological; Other; Biological; Other; Biological; Other; Biological; Other; Biological; Other
Intervention description(s): Participants aged 6 to less than (<) 24 months will receive MEDI-534, 10^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.; Participants aged 6 to <24 months will receive placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.; Participants aged 6 to <24 months will receive MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.; Participants aged 6 to <24 months will receive placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.; Participants aged 2 months will receive MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.; Participants aged 2 months will receive placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.; Participants aged 2 months will receive MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.; Participants aged 2 months will receive placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.; Participants aged 2 months will receive MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.; Participants aged 2 months will receive placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Respiratory Syncytial Virus (RSV); Parainfluenza Virus Type 3 (PIV3); MEDI-534
A Phase I Study of TAS-102 in Solid Tumors
Condition: Advanced or Metastatic Solid Tumors
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to evaluate the pharmacokinetics of TAS-102 after
      single and multiple dose in Chinese patients with solid tumor.
    

Detailed description: 
      This is an open-label, non-randomized, single group Phase 1 study of TAS-102, evaluating the
      pharmacokinetics, safety, and antitumor activity. Blood sampling will be performed during the
      first cycle (Day1 and Day 12) of therapy in all consenting patients.
    

Intervention name(s): TAS-102
Intervention type(s): Drug
Intervention description(s): TAS-102 (35 mg/m2/dose) orally, twice daily on days 1-5 and 8-12 of each 28-day cycle. Number of cycles: until at least one of the discontinuation criteria is met.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment