bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety of Tenofovir Disoproxil Fumarate (TDF) 300mg in Chinese Subjects With Chronic Hepatitis B (CHB)
Condition: Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multi-centre, double blind, double dummy, randomised, controlled study to evaluate
      the efficacy and safety of TDF 300mg QD versus ADV 10mg QD in Chinese subjects with CHB. This
      study is designed to demonstrate the superiority of TDF 300mg QD over ADV 10mg QD in treating
      Chinese subjects with CHB (hepatitis B e antigen [HBeAg] positive subjects and HBeAg negative
      subjects). It will also provide long-term efficacy and safety data (up to 240 weeks) for TDF
      300 mg administered once daily.
    

Detailed description: 
      This is a multi-centre, double-blind, double-dummy, randomised, controlled study to evaluate
      the efficacy and safety of TDF 300mg QD versus ADV 10mg QD in Chinese subjects with CHB. Four
      hundred and ninety-four subjects with CHB (200 HBeAg positive subjects and 294 HBeAg negative
      subjects) will be randomised (1:1ratio) to either TDF 300mg QD or ADV 10mg QD treatment arms.
      The primary endpoint is the proportion of subjects with blood hepatitis B virus (HBV)
      deoxyribonucleic acid (DNA) <400copies/mL (Roche COBAS Taqman HBV test) at Week 48 in HBeAg
      positive subjects with CHB and HBeAg negative subjects with CHB. This is a two-part study.
      The first treatment period (baseline to Week 48) will investigate the effects of TDF and ADV
      on safety and efficacy endpoints; dosing will be double-blind. This period will be followed
      by 192 weeks in which all subjects will receive open-label TDF (Week 49 to Week 240).
      Subjects will undergo regular safety and efficacy assessments every 4 weeks for the first 12
      weeks followed by every 12 weeks for a total of up to 5 years.
    

Intervention name(s): Tenofovir disoproxil fumarate (TDF) tablets; Adefovir dipivoxil (ADV) tablets
Intervention type(s): Drug; Drug
Intervention description(s): white, almond-shaped, film-coated tablets containing 300mg of TDF; white to off-white, round, biconvex tablets containing 10mg of ADV
Other intervention name(s): TDF tablet; ADV tablet
Intervention MeSH terms: Tenofovir; Adefovir; Adefovir dipivoxil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: tenofovir disoproxil fumarate; chronic hepatitis B; adefovir dipivoxil
A Controlled Trial of Losartan in Posttraumatic Stress Disorder
Condition: Posttraumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      This study is being conducted to determine if losartan, an angiotensin receptor blocker
      (ARB), is safe and effective in the treatment of posttraumatic stress disorder (PTSD)
      symptoms. The study is also intended to determine if certain genetic markers are useful in
      predicting PTSD symptom reduction with losartan. Approximately 160 subjects with chronic PTSD
      ages 18-65 will participate in this study across five sites. Subjects will be assigned by
      chance to take either flexibly dosed losartan (up to a maximum dosage of 100 mg) or placebo
      (which resembles the study drug but has no active ingredients), once a day for 10 weeks.
      Furthermore, it is hypothesized that CC homozygotes for rs4311 SNP in the ACE gene will have
      a superior response to losartan on PTSD symptoms compared to T carriers.
    

Detailed description: 
      There are limited current treatments available for PTSD, and the only FDA-approved
      medications are SSRIs, which were empirically found to be somewhat helpful. Losartan provides
      a potentially important and exciting development in that it is readily available, safe,
      inexpensive (available as a generic drug), and has a neurobiological mechanism based on
      recent exciting discoveries, as outlined below. This proposal is designed to test, in a
      multisite RCT, this novel, mechanistically-determined, safe and well-tolerated, potentially
      powerful treatment for PTSD symptoms.
    

Intervention name(s): losartan; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Angiotensin receptor blocker (ARB); Placebo
Other intervention name(s): Cozaar
Intervention MeSH terms: Losartan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: posttraumatic stress disorder; losartan; angiotensin receptor blocker
Food Concentrates Supplementation to Alleviate Asthma in Children
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether food concentrates supplementation
      (vegetable plus fruit, fish, probiotics) are effective to alleviate drug used, asthma
      symptoms and lung function in children due to asthma.
    

Detailed description: 
      The prevalence of asthma is increasing in Taiwan and worldwide. This could be related to
      dietary factors and their interactions with genes and the environment. Ample evidence from
      cross-sectional and case-control observational studies suggested that consumption level of
      fruits, vegetables, and potentially vitamins A, C, E from foods have negative association
      with asthma risk, and positive association with lung function. However, single nutrient
      supplementation neither improved asthma symptoms and lung function, nor reduced inflammatory
      mediators. Some studies had shown probiotics could regulate human immunity. A number of
      trials have suggested that fish oil supplement improves lung function and reduces
      inflammatory mediator. The potential interactions among multiple components in foods have
      been neglected in the past. Recently, observational studies on dietary pattern analyses or
      intervention trials modifying the overall dietary composition have caught tremendous
      scientific attentions. Therefore, the investigators will design an intervention trial with
      food-based principle to investigate the the joint effect of several beneficial dietary
      components on asthma symptoms. For practicality and efficiency, vegetable plus fruit
      concentrates, fish oil, and probiotic concentrate are considered as supplements to asthmatic
      children. The investigators hope that the study can provided a direction for dietary
      modification in asthma children.
    

Intervention name(s): food concentrates: fruit, vegetable, fish oil and probiotics
Intervention type(s): Dietary Supplement
Intervention description(s): comparison the effect of food concentrate
Other intervention name(s): fruit and vegetable concentrates; fish oil; probiotics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: asthma
A Study to Assess the Effect of Food on the Pharmacokinetics (PK) of AMG 510 in Healthy Participants
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the study is to evaluate the PK of AMG 510 administered in the
      fasted and fed state in healthy participants.
    


Intervention name(s): AMG 510
Intervention type(s): Drug
Intervention description(s): Oral Tablet
Other intervention name(s): Sotorasib
Intervention MeSH terms: Sotorasib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Healthy Participants; AMG 510; Sotorasib
A Safety and Efficacy Evaluation of Topical Treatments for Moderate-Severe Facial Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of the study is to compare the safety and efficacy of multiple formulations of
      BLI1100 to a control group and placebo in treating patients with moderate-severe acne
      vulgaris.
    


Intervention name(s): BLI1100-1; BLI1100-2; BLI1100-3; BLI1100-4; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): BLI1100-1 Topical gel; BLI1100-2 Topical gel; BLI1100-3 Topical gel; BLI1100-4 Topical gel; Placebo - Topical gel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
TARGeted Intraoperative radioTherapy With INTRABEAM as a Boost for Breast Cancer - A Quality Control Registry
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      Quality Control Registry for IORT used as an anticipiated boost with 20 Gy at the applicator
      surface followed by EBRT
    

Detailed description: 
      Quality Control Registry of a standard treatment with intraoperative radiotherapy during
      breast conserving surgery with 20 Gy at the applicator surface as an advanced boost followed
      by a shortened external beam radiotherapy. This is a prospective phase IV study to evaluate
      real life data of IORT Boost. Study runs in Germany with 13 active centers recruiting. Due to
      the nature of the study (registry) there is no need for randomization. Inclusion of n = >1000
      patients is planned.
    

Intervention name(s): IORT with 50 kV x-rays, 20 Gy
Intervention type(s): Radiation
Intervention description(s): Intraoperative radiotherapy with the INTRABEAM System with 20 Gy
Observational model: Ecologic or Community
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All patients with breast cancer and a tumor diameter < 3,5 cm plannend for breast
        conserving surgery. Intraoperative radiotherapy (IORT) is applied as an advanced boost with
        20 Gy at the applicator surface during surgery. Its feasibility was already shown. IORT as
        a boost is considered as one of several boost techniques in the S3-Leitlinie (national
        guideline) for breast cancer.
      
Keywords: IORT; Boost; Breast cancer; Local recurrence; Toxicity; LENT SOMA; TARGIT; Quality Control Registry
Plasma Adiponectin Level and Sleep Structures in Children With Prader-Willi Syndrome
Condition: Prader-Willi Syndrome; Obesity
MeSH terms: Prader-Willi Syndrome; Syndrome
Study type: Observational

Summary: 
      Context: Adiponectin is an adipose tissue-derived hormone with an insulin sensitizing effect,
      and has been related to obstructive sleep apnea syndrome. In addition, children with
      Prader-Willi syndrome (PWS) suffer from excessive daytime sleepiness and the abnormality of
      rapid eye movement (REM) sleep.

      Objective: To determine if the sleep stages are related to the plasma levels of adiponectin,
      resistin, and RBP4 (retinol binding protein-4), and whether these relationships are
      influenced by age, obesity and insulin resistance.
    

Detailed description: 
      This comparative study was carried out in 28 PWS children and 18 controls. The enrolled PWS
      children were volunteers out of a pool of approximately 100 PWS children followed at Samsung
      Medical Center [median age 8.0 years, interquartile range (7.0-10.5 years), BMI: median 24.2
      kg/m2 (23.0-27.5 kg/m2)] and 18 obese healthy children [median age 9.0 years interquartile
      range (7.0-11.0 years), BMI: median 24.2 kg/m2 interquartile range (23.1-27.6 kg/m2)].
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The study population comprised 28 children with PWS and 18 controls. The enrolled children
        with PWS were volunteers from a pool of approximately 100 children with PWS followed up at
        the Samsung Medical Center. The controls were healthy children from several elementary and
        middle schools located in the southern areas of Seoul.
      
Keywords: REM sleep; Adiponectin; Prader-Willi syndrome
Bilateral Ultrasound-Guided Transversus Abdominis Plane (Tap) Block and Erector Spinal Plane (Esp) Block
Condition: Pain, Postoperative; Cesarean Section; Erector Spinae Plane Block; Transversus Abdominis Plane Block
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Transversus Abdominis Plane Block (TAPB) is frequently used for the management of
      postoperative pain in patients undergoing cesarean section. Recently, Erector Spinae Plane
      Block (ESPB) has been defined and used in several clinical scenarios. However, data regarding
      the ESPB use in the aforementioned patient group is limited.
    


Intervention name(s): Procedure/Surgery: Transversus Abdominis Plane Block (TAPB); Procedure/Surgery: Erector Spinae Plane Block (ESPB)
Intervention type(s): Procedure; Procedure
Intervention description(s): Patients received TAPB postoperatively; Patients received ESPB postoperatively
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study of Navigation Skills in Cerebral Palsy for Assessment and Rehabilitation in Immersive Virtual Reality
Condition: Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      Spatial navigation refers to the ability to maintain a sense of direction/location while
      moving around the environment so to find one's way. It includes abilities such as orienting
      in complex environments,perceiving distance and planning routes to distant locations as well
      as mentally representing the reciprocal relations of landmarks in space (Lawton, 2010;
      Wolbers & Hegarty 2010. Spatial navigation involves the precision in encoding multisensorial
      (visual, vestibular, proprioceptive)experiences, as well as to form mental representations to
      be used to guide behavior (Bianchini et al.,2014).

      Cerebral Palsy (CP) is a neurodevelopmental disorder characterized by movement and posture
      disorders causing activity limitation. Impairment in many other functions is common in CP
      including visual spatial competences and spatial organization. In this study the
      investigators meant to explore the navigation and learning strategies in children with CP.
    


Intervention name(s): Orientation; walking
Intervention type(s): Other; Other
Intervention description(s): In the first group CP patients undergo a four week training with once daily sessions lasting 30 minutes. The treatment includes exercises to improve navigation competences and orientation. During walk in VR environment with labyrinths of increasing complexity. Exercises include abilities such as orienting in complex environments, perceiving distance and planning routes to distant locations. The presence of landmarks has been included in some exercises to facilitate allocentric orientation strategies.; In the second group CP patients undergo a four week training with once daily sessions lasting 30 minutes. The treatment includes exercises to improve walking and balance abilities. Using engaging VR environments (e.g. transfer your load from the left to the right side to avoid obstacles while skiing; shoot balls at targets inside an area; walk in a forest as fast as possible; hit as many elves as possible by squatting, and so on). No exercises for orientation are included in this group.
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
2.5% and 10% Phenylephrine for Mydriasis in Diabetic Patients With Darkly Pigmented Irides
Condition: Diabetes Mellitus
MeSH terms: Mydriasis; Diabetes Mellitus
Study type: Interventional
Phase: Phase 4

Summary: 
      To compare the clinical efficacy and systemic side effects between 2.5% and 10% phenylephrine
      for mydriasis in diabetic patient with darkly pigmented irides.
    

Detailed description: 
      One hundred patients with diabetes from Srinagarind Hospital Eye Clinic were enrolled and
      randomized into two groups by block randomization. In group I (50 patients), 1% tropicamide
      combined with 2.5% phenylephrine were administered to dilate pupil whereas 1% tropicamide
      combined with 10% phenylephrine were used in Group II (50 patients). Pupil diameter, blood
      pressure and heart rate were measured before and after eye drop instillations.
    

Intervention name(s): 2.5% or 10% phenylephrine
Intervention type(s): Drug
Intervention MeSH terms: Phenylephrine; Oxymetazoline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Diagnostic
Keywords: phenylephrine; mydriasis; diabetes mellitus
Effect of Bariatric Surgery "Digestive Adaptations III" on Cardiovascular Risk
Condition: Diabetes Mellitus; Metabolic Syndrome; Obesity; Atherosclerosis
MeSH terms: Atherosclerosis; Metabolic Syndrome
Study type: Observational

Summary: 
      Introduction- Primary prevention is the main strategy to control the global burden of
      cardiovascular disease. In clinical practice, food restriction represents a valuable
      preventive resource. However, low adhesion rates and diet abandonment are considered
      important obstacles in treatment. Considering the discovery of new markers and mechanisms
      that relate food restriction and to all other cardiovascular risk factors, it is possible and
      necessary to seek for efficient alternatives to increase adherence and effectiveness of the
      preventive dietetic treatment. Surgical procedures can be used as a mechanism to promote food
      restriction. The bariatric surgery have gained importance not only for its potential
      application in obesity treatment but also in the control of cardiovascular risk factors
      refractory to medical treatment. Among bariatric operations, there is a group called
      digestive adaptations III that has specific characteristics.This surgical intervention
      modifies intestinal tract by reducing gastric volume and performing an anastomosis between
      ileum and stomach, creating a bipartition in the gut. This structural modification promotes
      satiety and increased insulin sensitivity more intensely than other surgical strategies. The
      effects of Digestive Adaptation III surgery on cardiovascular risk factors and on markers
      related to the development of atherosclerosis are not yet established.

      Objectives - To investigate the effect of Digestive Adaptation III surgery on clinical and
      laboratory parameters and cardiovascular risk factors.

      Methods - Twenty diabetics volunteers refractory to medical treatment and who have abdominal
      obesity will be included in the study. Of this group, half will be randomly selected to
      perform the Digestive Adaptations III surgery. All participants will undergo clinical and
      biochemical tests on the same occasions, up to thirty days before surgery, three twenty-four
      months after surgery. On these occasions besides the lipid profile and glucose, we will
      determine incretin hormones, adipokines and assess the amount of epicardial fat.
    


Intervention name(s): Digestive Adaptations III surgery
Intervention type(s): Procedure
Other intervention name(s): Sleeve gastrectomy with transit bipartition
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The population will be selected in a primary care clinic.
      
Biospecimen description: 
      Whole blood samples will be retained for future exams.
    
Keywords: Atherosclerosis; Cardiovascular risk factors; Calorie restriction; Bariatric Surgery
A Study in Healthy Men to Test How Itraconazole Influences the Amount of BI 1810631 in the Blood
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objective of this trial is to investigate the effect of multiple doses of the strong
      CYP3A inhibitor and recommended Pglycoprotein (P-gp) inhibitor itraconazole on the
      pharmacokinetics of a single dose of BI 1810631 in plasma following oral administration.
    


Intervention name(s): BI 1810631; Itraconazole
Intervention type(s): Drug; Drug
Intervention description(s): BI 1810631; Itraconazole
Other intervention name(s): Sempera® Liquid
Intervention MeSH terms: Itraconazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
ADS-5102 for the Treatment of Levodopa Induced Dyskinesia (EASE LID Study)
Condition: Dyskinesia; Levodopa Induced Dyskinesia (LID); Parkinson's Disease
MeSH terms: Parkinson Disease; Dyskinesias
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multi-center, randomized, double-blind, placebo-controlled, 2-arm, parallel group
      study to evaluate the efficacy and safety of ADS-5102 extended release (ER) capsules, an
      investigational formulation of amantadine, dosed once nightly at bedtime for the treatment of
      levodopa induced dyskinesia (LID) in subjects with Parkinson's disease (PD). The novel
      pharmacokinetic profile of ADS-5102 is expected to achieve i) maximal concentrations in the
      early morning through mid-day, when LID can be troublesome, and ii) lower concentrations in
      the evening, potentially reducing the negative impact of amantadine on sleep. This
      pharmacokinetic profile could enable higher doses to be tolerated with a once-nightly ER
      formulation than can be tolerated with an immediate-release formulation. The once-nightly
      dosing regimen may also provide enhanced convenience and compliance.

      In a previous clinical study, ADS-5102 met its primary endpoint; LID was significantly
      reduced as measured by the change in UDysRS score over 8 weeks vs. placebo.
    


Intervention name(s): ADS-5102; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Oral capsules to be administered once nightly at bedtime, for 25 weeks; Oral capsules to be administered once nightly at bedtime, for 25 weeks
Other intervention name(s): amantadine HCl extended release
Intervention MeSH terms: Amantadine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Levodopa Induced Dyskinesia; LID; Parkinsonism
89Zr-J591 Anti-Prostate-Specific Membrane Antigen Monoclonal Antibody in Patients With Glioblastoma Multiforme
Condition: Glioblastoma
MeSH terms: Glioblastoma
Study type: Interventional

Summary: 
      The purpose of this study is to test a new imaging agent called 89Zr-J591 (stands for
      humanized antibody called J591, that is attached to a radioactive material called
      Zirconium-89) in patients with glioblastoma multiforme.
    


Intervention name(s): 89Zr-J591; PET/CT Scan; MRI; Blood draw
Intervention type(s): Drug; Device; Device; Other
Intervention description(s): The intervention is the administration of an injection of 18-19mg of unchelated J591 to reach the total administered dose of antibody followed by 5 mCi (+/- 10%) of 89Zr-J591 (1 to 2 mg) . After administration of the experimental tracer, the patient will undergo a Brain PET/CT scan 24 hours, 48 hours post injection and 3-8 days. The 48 hour scan is strongly suggested, but optional.; Bloods samples will be drawn immediately before and approximately 30 minutes after 89Zr-J591 injection.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: 89Zr-J591; 15-002