bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of Electronic LogMar Visual Acuity and Contrast Sensitivity in a Population of Contact Lens Wearers
Condition: Visual Acuity
MeSH terms: Hypersensitivity
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a bilateral, non-dispensing, randomized, cross-over, single-masked study. There are a
      total of 3 visits where all study endpoints will be measured in all subjects at baseline with
      habitual lenses and under the two testing treatments sequentially in separate visits based on
      the randomization scheme
    


Intervention name(s): senofilcon A; Control
Intervention type(s): Device; Device
Intervention description(s): Acuvue Oasys 1-Day; Trial Frame with best spherocylindrical refraction (SCR)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Study to Examine the Effect of Antacid and Omeprazole on the Single-Dose Pharmacokinetics of Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) in Healthy Adult Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the effect of a single dose of aluminum hydroxide/magnesium hydroxide/simethicone
      and omeprazole on the pharmacokinetics (PK) of TBPM, following a single dose of TBPM-PI-HBr
      in healthy adult subjects.
    


Intervention name(s): Tebipenem pivoxil hydrobromide (TBPM-PI-HBr); 20 mL aluminum hydroxide/magnesium hydroxide/simethicone (400 mg aluminum hydroxide/400 mg magnesium hydroxide/40 mg simethicone per 5 mL); Omeprazole
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Tebipenem pivoxil hydrobromide (TBPM-PI-HBr) 600 mg single-dose given orally.; 20 mL aluminum hydroxide/magnesium hydroxide/simethicone (400 mg aluminum hydroxide/400 mg magnesium hydroxide/40 mg simethicone per 5 mL) oral suspension.; 40 mg (1 x 40 mg capsule) omeprazole administered QD
Other intervention name(s): TBPM-PI-HBr; SPR994
Intervention MeSH terms: Simethicone; Omeprazole; Aluminum Hydroxide; Magnesium Hydroxide; Aluminum hydroxide, magnesium hydroxide, drug combination; Aluminum hydroxide, magnesium hydroxide, simethicone drug combination; TEMPO
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
A Phase I Clinical Trial of Bevacizumab Injection
Condition: Rectal Cancer; Lung Cancer; Ovarian Cancer; Cervical Cancer; Glioblastoma
MeSH terms: Glioblastoma
Study type: Interventional
Phase: Phase 1

Summary: 
      Recombinant humanized monoclonal antibody injection against human vascular endothelial growth
      factor (bevacizumab) is Avastin produced by Zhengda Tianqing Pharmaceutical Group Co., Ltd
      Biological similar drugs. Its mechanism is to prevent VEGF from binding to its natural
      receptor VEGFR, inhibit the proliferation and activation of vascular endothelial cells, and
      play an anti angiogenesis and anti-tumor role by binding with VEGF. A randomized,
      double-blind, single dose, parallel comparison of bevacizumab injection and Avastin is
      planned The phase I clinical study on the similarity of pharmacokinetics and safety of
      traditional Chinese medicine in healthy male volunteers aims to compare bevacizumab injection
      with Avastin The similarity of pharmacokinetics, tolerance, safety and immunogenicity.
    


Intervention name(s): Bevacizumab injection; Bevacizumab injection（Avastin）
Intervention type(s): Drug; Drug
Intervention description(s): Recombinant humanized monoclonal antibody injection against human vascular endothelial growth factor; Recombinant humanized monoclonal antibody injection against human vascular endothelial growth factor
Intervention MeSH terms: Bevacizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Artificial Pancreas in Latin America
Condition: Diabetes
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      The purpose of this study is to use closed-loop systems with the algorithms designed by the
      University of Virginia and by the Instituto Tecnologico de Buenos Aires (ITBA)/ Universidad
      Nacional de La Plata (UNLP)/ Universidad Nacional de Quilmes (UNQ) to determine the infusion
      of insulin in a prolonged period of time in patients with type 1 diabetes mellitus (T1DM).
    

Detailed description: 
      Aims:

        1. To test University of Virginia closed-loop algorithm with meal announcement for 36 hours
           at our facilities.

        2. To test the ability of the closed-loopInstituto Tecnologico de Buenos Aires (ITBA)/
           Universidad Nacional de La Plata (UNLP)/ Universidad Nacional de Quilmes (UNQ) algorithm
           without meal announcement to maintain glucose control for 2 periods of 12 hours

      In both cases, the adequate operation of the system will be considered verified if the system
      works properly at least 80% of the total connection time .
    

Intervention name(s): 1° Phase: UVa algorithm 2° Phase: ITBA/UNLP algorithm
Intervention type(s): Device
Intervention description(s): The UVa algorithm is an already established mathematical model that can be programmed in DiAs software to manage glycaemia in T1DM through a subcutaneous insulin pump and a continous glucose monitoring. This algorthm works on a meal announcement basis and will be tested during the first phase of the trial. The ITBA/UNLP algorithm is a new development with safety mechanisms improved and without need of meal anouncement. This algorithm will be tested during the second phase of the trial.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: "Artificial Pancreas"; "control System"; "Closed loop"; diabetes; "T1DM"; "pump"; algorithm; CGM
Prevalence of Polycystic Ovary Syndrome (PCOS) in Obese Premenopausal Women
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Observational

Summary: 
      Between 40% and 85% of women with Polycystic Ovary Syndrome (PCOS) are overweight or obese
      and obesity is closely linked to the development of PCOS. Although it is well established
      that obesity increases the severity of the clinical features of PCOS, data regarding the
      prevalence of PCOS in obese women and the change in body weight in women with PCOS over time
      are scares. In a prevalence study it was investigated whether obesity increases the risk of
      PCOS in the general population and they demonstrated that the prevalence rate of PCOS in
      underweight, normal-weight, overweight, and obese women were 8.2, 9.8, 9.9, and 9.0%,
      respectively, similar to that observed in the general population. These results suggest that
      the risk of PCOS is only minimally increased with obesity. On the other hand, in a Spanish
      prevalence study among overweight and obese subjects, they demonstrated a 28.3% prevalence of
      PCOS, which is markedly higher compared with the 5.5% prevalence of PCOS in lean women in
      Spain.

      First the investigators aim to estimate the prevalence/probability of PCOS among obese,
      premenopausal women (between 18 and 50 years) with no symptoms of classic menopausal symptoms
      in Sweden. Secondly, to elucidate whether women diagnosed with PCOS respond to standard
      weight reduction regime to the same extent as women without PCOS.
    


Intervention name(s): Weight reduction regimen
Intervention type(s): Other
Intervention description(s): The dietary intervention begins with a 12-weeks VLCD/LCD period. The diet comprise of 3 to 5 portions liquid diet with a daily energy intake of 450-800 kcal. In addition, patients will be encouraged to drink 1,5-2L daily of non-caloric beverages (<6 kcal/100 ml). All patients will have scheduled nurse visits at week 0 (baseline), 2, 5, 8, and 12. At these visits general well-being and body weight will be monitored. The patient will also be given support and counselling to enhance compliance to the VLCD/LCD diet.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        All obese women between 18 and 50 years referred to a weight reduction treatment program at
        the Sahlgrenska Obesity Center at Sahlgrenska University hospital will, after oral and
        written informed consent, be screened for the diagnosis of PCOS according to NIH or
        Rotterdam diagnostic criteria depending on the availability of ultrasonography.
      
Keywords: PCOS
Dynamic Oscillatory Stretch Technique Versus Static Stretching In Reduced Hamstring Flexibility
Condition: Hamstring Tightness
Study type: Interventional

Summary: 
      This study compared the effects of dynamic oscillatory stretch technique (DOS) and static
      stretching (SS) technique in order to improve hamstring extensibility in healthy individuals
      with asymptomatic hamstring tightness. Half of study participants received DOS whereas other
      half received static stretching technique.
    

Detailed description: 
      This was a single blind randomized control trial conducted at District Head Quarter teaching
      hospital Sargodha, Sargodha institute of health sciences Sargodha, Sadiq hospital Sargodha
      (march 2018-June 2018). Sample size of 83 individuals was calculated through Open Epi tool
      version 3 with 95 % confidence interval (CI), and power 80%. 83 individuals were screened out
      on the basis of inclusion and exclusion criteria. Individuals of this selected population
      were randomly allocated as 42 individuals in Dynamic Oscillatory Stretch(DOS) group and 41
      individuals in Static Stretching(SS) group by sealed envelope method.

      After the application of hot pack treatment of 7-10 minutes to both groups dynamic
      oscillatory stretch technique (30 repetitions each of 2 seconds stretch duration in one
      session) was applied to DOS group and SS stretching (2 repetitions each of 30 seconds in one
      session) was applied to SS group.

      Assessment was done at baseline, immediate post-intervention levels (immediately) and
      post-intervention level after 1 hour. At baseline and immediately post-intervention level
      there was no dropout but after 1 hour post-intervention level there were two dropouts from
      DOS group and 1 dropout from SS group. 40 individuals were analyzed in each DOS and SS group.
      Data analysis was done through Statistical Package of Social Sciences(SPSS) version 20.
      Normality of different variables was assessed. Shapiro-Wilk test provided the basis for
      normality distribution of data.
    

Intervention name(s): Group I Experimental DOS; group II SS group
Intervention type(s): Other; Other
Intervention description(s): After the application of hot pack treatment of 7-10 minutes, dynamic oscillatory stretch(DOS) technique (30 repetitions each of 2 seconds stretch duration in one session) was applied to DOS group. An experienced orthopedic manual physical therapist provided these techniques to patients .; After the application of hot pack treatment of 7-10 minutes , Static stretching (2 repetitions each of 30 seconds in one session) was applied to SS group. An experienced orthopedic manual physical therapist provided these techniques to patients .
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Flexibility; Extensibility; Static stretching
Evaluation of EndoZip System in Obese Patients Who Failed to Reduce Weight With Non-surgical Weight-loss Methods
Condition: Obesity
MeSH terms: Weight Loss
Study type: Interventional

Summary: 
      A multicenter, prospective, single-arm, open-label, controlled clinical trial aimed to
      evaluate the safety and effectiveness of the EndoZip system procedure, coupled with lifestyle
      modifications, for weight reduction in obese patients with BMI of 30-40 kg/m2.
    

Detailed description: 
      study will include up to 45 (10-20 patients per site), ages of 21 -70 of obese patients who
      failed to reduce weight with non-surgical weight-loss methods.

      The duration for each participant will be 12 months and will include the following follow up
      visits and procedures:

        -  Office visits: screening, 1 week, and 1, 2, 4, 6, 8, 10, and 12 month(s)

        -  Remote follow up (by Phone): 3, 5, 7, 9, and 11 month(s)

        -  Endoscopy procedure: baseline, 2 and 6 months post EndoZip procedure

        -  Motility evaluation by Gastric Emptying Breath Test (GEBT): baseline, 6 months

        -  Physical examination, vital signs, waist circumference and BMI: baseline, 1 week, 1, 2,
           4, 6, 8, 10 and 12 months

        -  Blood tests: baseline,2, 6 and 12 months

        -  IWQOL-Lite: baseline, 2, 6 and 12 months

        -  Psychological health questionnaire-9 (PHQ-9) :baseline

        -  Sleep Apnea (only for the relevant population): baseline 2, 6 and 12 months

      The patient will required to follow a specific diet and to have a physical activity during
      the study period ( 12 month).
    

Intervention name(s): EndoZip System
Intervention type(s): Device
Intervention description(s): The Nitinotes EndoZip system is designed to allow for the creation of multiple internal gastric segmentation (4-8) in the stomach by using an endoscopic approach. The system allows the forming of wall-to-wall longitudinal attachments of the anterior and posterior stomach walls, creating multiple strictures within.
Creation of this segmentation may significantly reduce gastric volume, may affect gastric motility and consequently, reduce weight.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Effects of 24-week Computerized Cognitive Training in Patients With MCI and AD
Condition: Mild Cognitive Impairment; Alzheimer Disease
MeSH terms: Alzheimer Disease; Cognitive Dysfunction
Study type: Interventional

Summary: 
      This study aims to testify multi-domain effects of computerized cognitive training in
      patients with mild cognitive impairment and mild Alzheimer's disease through
      multi-dimensional evaluation.
    

Detailed description: 
      This study aimed to elucidate the neural process enhancement and remodulation in gut microbes
      resulting from older adults with MCI and mild AD in a randomized controlled trial of a
      24-week computerized cognitive training (CCT) program.

      After recruitment and baseline assessments, pairs of participants with MCI and mild AD would
      be randomly allocated into the corresponding subgroup. Participants in CCT group will receive
      a computerized multidomain cognitive training program (www.66nao.com) and will be required to
      complete at least 30 minutes of training per day (3 cycle of 5 2-min tasks), 5 days a week
      for 24 weeks. Adherence to the intervention will be supervised by an independent researcher.
      The number of training days and training hours per day will be recorded. Patients in control
      group received treatment as usual (TAU) for 24 weeks. The neuropsychological measures will be
      performed at baseline, follow-up at 4 weeks, 12 weeks, and 24 weeks; functional Near-Infrared
      Spectroscopy (fNIRS) data and fecal samples will collected at baseline and 24 weeks.
    

Intervention name(s): Computerized Cognitive Training; Treatment As Usual
Intervention type(s): Other; Other
Intervention description(s): Participants in intervention group will receive a multidomain, adaptive computerized cognitive training program (www.66nao.com) and will be required to complete at least 30 minutes of training per day (3 cycle of 5 2-min tasks), 5 days a week for 24 weeks. Multidomain coverage paradigms include working memory, calculation, processing speed, attention, executive function, and short-term and long-term memory.; Patients in control group will receive TAU for 24 weeks, which includes (1) regular medication management from the Memory Clinic, if applicable; (2) basic health education at each follow-up (face to face) and twice per month on the internet .
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: After recruitment and baseline assessments, pairs of participants with MCI and mild AD will be randomly allocated into either the CCT group and the control group. Participants in CCT group will receive a multidomain adaptive computerized cognitive training program (www.66nao.com) for 24 weeks. Patients in control group will receive treatment as usual (TAU) for 24 weeks.
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: computerized cognitive training; functional near-infrared spectroscopy; mild cognitive impairment; Alzheimer's disease; brain-gut-microbiota axis; gut microbiota
A Phase 1/2, RU-101 Ophthalmic Solution in Patients With Severe Dry Eye
Condition: Dry Eye
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Objectives:

      Primary

        -  To determine the safety and tolerability of escalating doses of RU-101 for 4 weeks in
           patients with severe dry eye

      Secondary

        -  To explore the efficacy of RU-101

        -  To explore optimal endpoints for future studies
    

Detailed description: 
      This is a Phase 1/2, first-in-human, multicenter, dose escalation, double-masked, placebo
      controlled study consisting of two stages. In Stage I, 3 cohorts are planned to evaluate
      escalating doses of RU 101 ophthalmic solution, instilled 6 times daily into each eye for 4
      weeks (28 days). Each cohort will comprise 4 patients randomized 3:1 to RU-101 or placebo. A
      masked safety data review will be performed prior to each dose escalation to determine if any
      dose limiting toxicities (DLTs) occurred and to define the MTD or highest dose to be used in
      Stage II. In Stage II, an expanded cohort will receive the dose defined in Stage I (MTD or
      highest dose if MTD is not reached), instilled 6 times daily into each eye for 12 weeks (84
      days). The expanded cohort will comprise approximately 96 patients randomized 1:1 to RU-101
      or placebo, provided in a double-masked manner.
    

Intervention name(s): RU-101
Intervention type(s): Biological
Intervention description(s): Recombinant human serum albumin
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: sever dry eye,keratoconjunctivitis sicca
Basmisanil Positron Emission Tomography Study in Japanese Volunteers
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the relationship between basmisanil plasma concentrations and the
      occupancy of Gamma-Amino Butyric Acid A (GABAA) receptor subtypes containing an alpha5 (α5)
      subunit in healthy Japanese volunteers. Each participant will have two post-screening imaging
      sessions. In the first imaging session, participants will have a baseline Positron Emission
      Tomography (PET) scan. In the second imaging session, participants will receive a single oral
      dose of basmisanil, followed by two on-treatment PET scans at about 4 and 10 hours post-dose.
    


Intervention name(s): Basmisanil
Intervention type(s): Drug
Intervention description(s): Single oral dose: Basmisanil doses between 20 milligrams (mg) and 960 mg may be used in this study. The planned doses for the first two participants are 160 mg and 480 mg, respectively. Basmisanil dose for subsequent participants will be decided by the investigator and sponsor during the study, based on on-going review of emerging data.
Other intervention name(s): RO5186582, RG1662
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Randomized Trial of Casting Techniques for Displaced Forearm Fractures
Condition: Displaced Forearm Fractures
MeSH terms: Fractures, Bone
Study type: Interventional

Summary: 
      It is recognized that fractures of the distal radius and forearm occur in approximately one
      in 100 children and adolescents every year. Though closed manipulation and cast
      immobilization of displaced injuries is the mainstay of treatment in the majority of cases,
      the optimal type of cast remains debatable. Though well-molded casts theoretically provide
      the best ability to maintain fracture alignment, risks of circumferential immobilization in
      acute injuries include neurovascular compromise. Splitting, or bivalving, casts may reduce
      these risks, but the effect on fracture stability is unknown. The proposed investigation
      seeks to address the simple question of whether circumferential or bivalved casts provide the
      best outcomes.
    


Intervention name(s): Bivalved cast; Circumferential cast
Intervention type(s): Other; Other
Intervention description(s): Circumferential cast will be applied following closed reduction and then bivalved using a cast saw; Circumferential cast will be applied following closed reduction
Intervention MeSH terms: Calpastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Casting techniques; Bivalved cast; Circumferential cast; Displaced distal radius fracture; Children
A Feasibility Study of Oral Adjuvant Chemotherapy With S-1
Condition: Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 2

Summary: 
      The investigators confirm the feasibility of 1-year administration of oral fluoropyrimidine
      S-1 as an adjuvant chemotherapy for the patient who received complete resection of non-small
      cell lung cancer. The investigators presume they can achieve high completion rate with low
      toxicity.
    

Detailed description: 
      Chemotherapy comprised eight courses (4-week administration, 2-week withdrawal) of S-1 (FT,
      gineracil, oteracil potassium; Taiho Pharmaceutical, Tokyo, Japan) at 80-120 mg/body/day
      according to body surface area (BSA): BSA <1.25 m2, 80 mg/day; BSA >1.25 m2 but <1.5 m2, 100
      mg/day; and BSA >1.5 m2, 120 mg/day. S-1 was administered orally, twice daily after meals,
      starting within 4 weeks after surgery.
    

Intervention name(s): S-1
Intervention type(s): Drug
Intervention description(s): Chemotherapy comprised eight courses (4-week administration, 2-week withdrawal; total 1 year) of S-1 at 80-120 mg/body/day according to body surface area (BSA)
Other intervention name(s): Oral fluoropyrimidine S-1
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Non-small cell lung cancer; Adjuvant chemotherapy; oral fluoropyrimidine; S-1; Feasibility study; Surgery