bioihbjkbjnl/mcl2 huggingface dataset:
Use of Toric Intraocular Lens to Neutralize Keratometric Astigmatism
Condition: Cataract; Astigmatism
MeSH terms: Cataract; Astigmatism
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate neutralization of keratometric astigmatism in
      patients with cataract and astigmatism higher than 1 diopter, with phaco surgery and the
      implantation of a toric intraocular lens.
    

Detailed description: 
      Patients with Cataract are treated with phacoemulsification of the lens with an implantation
      of an intraocular lens. Besides cataract, almost 25% of these patients have some degree of
      Astigmatism; when it is higher than 1 diopter, it is possible to neutralize it with an
      implantation of a toric intraocular lens.
    

Intervention name(s): Acrysof Toric one-piece intraocular lens
Intervention type(s): Procedure
Intervention description(s): Cataract Surgery with a intraocular lens implantation
Other intervention name(s): Acrysof Single Piece Natural Toric Lens. ALCON LABORATORIES INC
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Astigmatism; Cataract
Dupilumab in Japanese Patients With Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 3

Summary: 
      Primary Objective:

      To evaluate the efficacy of dupilumab administered concomitantly with topical corticosteroids
      (TCS)

      Secondary Objective:

      To evaluate the efficacy of dupilumab administered concomitantly with TCS. To assess the
      safety of dupilumab over 16 weeks of treatment when administered concomitantly with TCS in
      participants.

      To assess immunogenicity as determined by the incidence, titer, and clinical impact of
      treatment-emergent anti-drug antibodies (ADA) to dupilumab over time in pediatric patients
      with atopic dermatitis (AD) (aged ≥6 months to <18 years old) To assess the concentration of
      dupilumab in serum following administration concomitantly with TCS.
    

Detailed description: 
      For participant who declines to enter open-lebal extension (OLE), the duration of the study
      for each participant is approximately 33 weeks (including screening and follow-up) For
      participant choosing enter OLE, the duration is approximately 21 weeks (including screening)
      plus 3 years OLE period or until approval of the indication in Japan whichever is sooner.
    

Intervention name(s): Placebo; Dupilumab SAR231893
Intervention type(s): Drug; Drug
Intervention description(s): Pharmaceutical form:solution for injection Route of administration: subcutaneous (SC); Pharmaceutical form:solution for injection Route of administration: subcutaneous (SC)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Proton Pump Inhibitor Empirical Treatment in Management of Outpatients With Gastroesophageal Reflux Disease.
Condition: Patients With Typical Symptoms of GERD (GERD Q >= 8)
MeSH terms: Gastroesophageal Reflux
Study type: Observational

Summary: 
      China Survey of Proton Pump Inhibitor Empirical Treatment in Management of Outpatients with
      Gastroesophageal Reflux Disease
    

Detailed description: 
      To estimate the overall responder rate after 4 weeks of Proton Pump Inhibitor empirical
      treatment This will be a multicenter prospective observational study carried out in China.
      Investigator will collect data in a pre-specified Case Report Form from the outpatient.
      Informed consents will be needed. Investigator will provide patient diary card to each
      patient for them to note down the symptom frequency every day. Main data from each outpatient
      will include demographics, Gerd Q, symptom frequency and Proton Pump Inhibitor empirical
      treatment. Data from each outpatient will be collected on the screening day, 2 weeks and 4
      weeks.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The subject population that will be included in the NIS are the consecutive outpatients
        between 18 and 65 years old with Gerd Q ≥ 8, who will not have endoscopy within 4 weeks
        while gastroenterologists already prescribe PPI as empirical treatment.
      
Keywords: Proton Pump Inhibitor, GERD, GERD Q
Aminophylline Prophylaxis For Postdural Puncture Headache
Condition: Postdural Puncture Headache
MeSH terms: Post-Dural Puncture Headache; Headache
Study type: Observational

Summary: 
      postdural puncture headache is a rare but serious complication of spinal anesthesia. many
      drugs were studied in prevention or treatment of that complication. However, there are
      limited numbers of trials about intravenous aminophylline for prevention. because of that we
      retrospectively aimed to investigate the effectiveness of aminophylline for postdural
      puncture headache in cesarean section.
    

Detailed description: 
      retrospective trial about the effect of intravenous aminophylline for prevention of PDPH
      after caserean section with spinal anesthesia
    

Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        patient records form who experinced headache after caserean section with spinal anesthesia
        were retrospectively evaluated
Safety and Efficacy Study of Ladostigil in Mild to Moderate Probable Alzheimer's Disease
Condition: Alzheimer's Disease; Dementia; Memory Loss; Cognitive Impairment
MeSH terms: Alzheimer Disease; Dementia; Memory Disorders; Amnesia; Cognitive Dysfunction
Study type: Interventional
Phase: Phase 2

Summary: 
      For many, Alzheimer's disease is the number one medical issue facing our aging society. It is
      a late onset neurodegenerative disease, frequently under diagnosed, that impairs memory and
      cognitive performance. There are no known treatments that can either prevent or reverse its
      progression. Consequently, there still remains a need to evaluate treatments which can better
      stabilize the symptoms of this disease. These symptoms frequently include decreased
      functional capacity and negative psychological attributes (e,g, depression, anxiety) in
      association with the memory and cognition deficits. This current study is being done to
      assess an investigational compound that has been designed to not only improved the cognitive
      status of affected patients but to also better manage all symptoms. Hence, the ultimate goal
      is to provide patients with an improved quality of life by slowing the progression of this
      neurodegenerative disease
    

Detailed description: 
      This is a phase II, proof of concept study to evaluate the safety and efficacy of the
      investigational compound ladostigil versus placebo in mild to moderate Alzheimer's disease
      patients. The randomized, double-blind, placebo-controlled phase of the trial will be 26
      weeks in duration and will involve two cohorts (i.e. one arm receiving ladostigil and one arm
      receiving placebo). After the initial 26 week period, all participating subjects will receive
      26 weeks of treatment with ladostigil (i.e. the open label phase). A total of five
      territories will be participating in this trial. These include Austria, Croatia, Germany,
      Serbia and Spain.
    

Intervention name(s): ladostigil hemitartrate
Intervention type(s): Drug
Intervention description(s): Final dosage strength of 80mg b.i.d will begin at Day 22 following a 21 day dose escalation phase involving 40mg and 60mg b.i.d dosage strengths. Oral, solid dosage.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Alzheimer's Disease; Dementia; Memory Loss; Cognitive Impairment; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Delirium, Dementia, Amnestic, Cognitive Disorders; Mental Disorders; Depression; Anxiety
Trial to Demonstrate Equivalent Immunogenicity of CAIV-T and FLUMIST in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 3

Summary: 
      -  Primary objective is to demonstrate equivalent immunogeniticity of CAIV-T and FluMist

        -  Secondary objective of this study is to assess the safety and tolerability of CAIV-T
           compared to FluMist
    


Intervention name(s): CAIV-T; CAIVT; FluMist
Intervention type(s): Biological; Biological; Biological
Intervention description(s): The total volume of 0.2 mL will be administered intranasally with a spray applicator (approximately 0.1 mL into each nostril).; The total volume of 0.5 mL will be administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Standarization for Stappler Application During Sleeve Gastrectomy
Condition: Obesity
MeSH terms: Obesity
Study type: Observational [Patient Registry]

Summary: 
      Sleev gastrectomy is a procedure performed for permanent treatment of obesity. For the
      procedure, cutting of the stomach is performed with differents long of stapplers.

      The aim of the study is to determine wich long of stappler is applicable in any stage of the
      procedure ans the variation expected.
    

Detailed description: 
      After permormed laparoscopic sleeve gastrectomy the stonach retrieved for pathology study
      will be messured in three ponts: antrum, body and fundus.

      In each point medition of the two walls and any wall (anterior and posterior) will be
      messurd.

      Those data will be stariscally analized to perform a applicable guidelines for stapller
      selection.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients underwnt laparoscopic sleev gastrectomy between 18 y.o. and 70 y.o.
      
Keywords: stapplers- obesity- stomach
Evaluation of Efficacy and Safety of Adapalene 0.1%/Benzoyl Peroxide 2.5% Gel in the Treatment of Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to demonstrate the efficacy of Adapalene 0.1%/Benzoyl Peroxide
      2.5% Gel in the treatment of acne vulgaris. The safety will also be evaluated.
    


Intervention name(s): Adapalene-BPO Gel
Intervention type(s): Drug
Intervention description(s): Apply 1 gram of the investigational drug every night on whole face.
Intervention MeSH terms: Adapalene
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Adapalene; Benzoyl Peroxide; Acne Vulgaris
The Impact of Bariatric Surgery on Non-alcoholic Fatty Liver Disease
Condition: Obesity; NAFLD
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Observational

Summary: 
      Up to 300 million people have a BMI over 30kg/m2. Obesity is the cause of many serious
      diseases, such as type 2 diabetes, hypertension and NAFLD. Bariatric surgery is the only
      effective method of achieving weight loss in patients with morbid obesity.

      The aim of the study is to assess the impact of bariatric surgery on non-alcoholic fatty
      liver disease in patients operated on due to morbid obesity.
    

Detailed description: 
      Investigators include 20 patients qualified for the bariatric procedure with BMI > 40 kg/m2
      or a BMI > 35kg/m2 with the presence of comorbidities. The average body weight in the group
      was 143.85kg with an average BMI of 49.16kg/m2. Before the procedure, investigators evaluated
      the severity of the non-alcoholic fatty liver disease in each patient using the Sherif Saadeh
      ultrasound scale. Investigators also evaluated the levels of the liver enzymes. Follow up was
      performed twelve months after surgery.
    

Intervention name(s): Bariatric surgery
Intervention type(s): Procedure
Intervention description(s): Laparoscopic Sleeve Gastrectomy (LSG) Laparoscopic Roux-en-Y Gastric Bypass (LRYGB)
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The analysis included prospectively collected data from consecutive patients electively
        operated for morbid obesity in 2015.
      
Keywords: obesity; bariatric surgery; non-alcoholic fatty liver disease
Rectal Misoprostol Versus Sublingual Misoprostol Prior to Myomectomy
Condition: Bleeding During Myomectomy
Study type: Interventional
Phase: Phase 4

Summary: 
      the aim of the study is To compare the effectiveness of rectally administered prostaglandin
      E1 synthetic analogue (misoprostol) 400 microgram versus sublingually administered
      misoprostol before myomectomy to decrease blood loss during and after the operation.
    


Intervention name(s): rectal misoprostol; sublingual misoprostol
Intervention type(s): Drug; Drug
Intervention description(s): patients will take 2 tablets of rectally misoprostol 400 microgram 60 minutes before the procedure; patients will take 2 tablets of sublingual misoprostol 400 microgram 60 minutes before the procedure
Intervention MeSH terms: Misoprostol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Pharmacokinetics (Drug Levels in Blood) of BMS-986165 When Taken as Various Solid Tablet Prototypes by Healthy Participants
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to characterize the pharmacokinetics (the way the body absorbs,
      distributes and eliminates the drug) of BMS 986165 given in the form of various prototypes of
      solid tablets to healthy participants.
    


Intervention name(s): BMS-986165; BMS-986165 prototype 1; BMS-986165 prototype 2
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Specified dose on specified days; Specified dose on specified days; Specified dose on specified days
Intervention MeSH terms: Deucravacitinib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Exploratory Study of NS-089/NCNP-02 in DMD
Condition: Duchenne Muscular Dystrophy
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study is designed to assess the safety, tolerability, efficacy and pharmacokinetics (PK)
      of NS-089/NCNP-02 in subjects diagnosed with Duchenne muscular dystrophy (DMD), and to
      determine the dosage for subsequent studies.
    


Intervention name(s): NS-089/NCNP-02
Intervention type(s): Drug
Intervention description(s): NS-089/NCNP-02 for Infusion is packaged as 50 mg/mL with 3 mL per vial. Study dosages will be infused over a 1 hour period at the following dose levels.
"[Part 1] NS-089/NCNP-02 is administered at dose levels 1 and 3 in Cohort 1 and at dose levels 2 and 4 in Cohort 2.
Dose level 1: 1.62 mg/kg once weekly for 2 weeks; Dose level 2: 10 mg/kg once weekly for 2 weeks; Dose level 3: 40 mg/kg once weekly for 2 weeks; Dose level 4: 80 mg/kg once weekly for 2 weeks [Part 2] Based on the results from Part 1, two dosages are selected as study dosages in Part 2. Each selected dose are administered once a week for 24 weeks."
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Duchenne Muscular Dystrophy
Impact of Graduating to Resilience on Child Development in Uganda
Condition: Child Development
Study type: Interventional

Summary: 
      This study is an intervention trial that aims to estimate the impact of the Graduating to
      Resilience (G2R) program on child development in Uganda. In previous trials, the G2R program
      has generated large, positive impacts on household assets, consumption, income and food
      security. The investigators will revisit a sample of households enrolled in a G2R trial
      conducted in Uganda in 2019-2021 (AEARCTR-0004080) and assess children born during the
      intervention period.
    


Intervention name(s): G2R with individual coaching; G2R with group coaching
Intervention type(s): Other; Other
Intervention description(s): Consumption support in the form of a monthly cash transfer for 12 months, totaling US$280-$320;
A one-time "asset" transfer of US$300 delivered ~7 months into the program;
Enrollment, training, and support to participate in a Village Savings and Loans Association (VSLA) or similar group;
Individual coaching at home from a trained coach using a structured curriculum focused on essential topics, including: child nutrition; infant and young child feeding (IYCF) best practices; Water, Sanitation and Hygiene (WASH) practices and practical solutions; preventative health care; positive parenting and life skills; gender; climate risk mitigation strategies; rights, linkages, and access to services.; Consumption support in the form of a monthly cash transfer for 12 months, totaling US$280-$320;
A one-time "asset" transfer of US$300 delivered ~7 months into the program;
Enrollment, training, and support to participate in a Village Savings and Loans Association (VSLA) or similar group;
Group coaching in a community setting from a trained coach using a structured curriculum focused on essential topics, including: child nutrition; infant and young child feeding (IYCF) best practices; WASH practices and practical solutions; preventative health care; positive parenting and life skills; gender; climate risk mitigation strategies; rights, linkages, and access to services.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
A Study to Evaluate Pharmacokinetics, Safety and Tolerability of MEDI0382 in Renal Impairment Subjects
Condition: Renal Insufficiency
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      A phase 1 open-label, single-dose study to evaluate the pharmacokinetics (PK), safety,
      tolerability and immunogenicity of MEDI0382 in subjects with renal impairment.
    

Detailed description: 
      This is an open-label, single-dose, parallel group study to evaluate the PK, safety,
      tolerability, and immunogenicity of MEDI0382 in subjects with renal impairment. Enrollment of
      approximately 40 subjects across multiple sites is planned. Subjects will be divided into 4
      groups based on renal function.
    

Intervention name(s): MEDI0382
Intervention type(s): Drug
Intervention description(s): MEDI0382 administered subcutaneously
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Kidney Failure, Kidney Insufficiency, Renal Failure, Renal Insufficiency, MEDI0382
Chinese Validation of the Simplified Evaluation of CONsciousness Disorders（SECONDs）
Condition: Brain Diseases; Vegetative State; Unconsciousness; Central Nervous System Diseases
MeSH terms: Nervous System Diseases; Brain Diseases; Central Nervous System Diseases; Persistent Vegetative State; Consciousness Disorders; Unconsciousness
Study type: Interventional

Summary: 
      The aim of this study was to translate the SECONDs from French into Chinese and assess the
      validity and reliability of the Chinese version of the SECONDs .
    

Detailed description: 
      To promote accurate assessments of DoC patients and the development of clinical research on
      DoC in China, we here propose and validate a version of the SECONDs translated into Mandarin
      Chinese. Hence, this study aims to assess the concurrent validity (compared with the CRS-R
      which has already been translated and validated in Mandarin), intra-rater reliability, and
      inter-rater reliability of the Chinese version of the SECONDs
    

Intervention name(s): Simplified Evaluation of CONsciousness Disorders (SECONDs)
Intervention type(s): Diagnostic Test
Intervention description(s): All patients were assessed by the Simplified Evaluation of CONsciousness Disorders (SECONDs) and Coma Recovery Scale-Revised (CRS-R)
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Each patient was assessed by three distinct assessors who were experienced and trained to use the CRS-R. All assessments were completed within two weeks (i.e., five CRS-R to obtain a reliable diagnosis [17], and 7 SECONDs performed by 3 different assessors in the 2 weeks) in five different sessions. Session 1 included one evaluation with the CRS-R performed by one assessor (i.e., concurrent validity) and three evaluations with the SECONDs performed by two assessors (i.e., intra-rater reliability and inter-rater reliability). The other sessions (2 to 5) each included one evaluation with the SECONDs and one evaluation with the CRS-R (i.e., concurrent validity) performed by two assessors. Each SECONDs was performed alternatively either before or after the CRS-R assessment. To avoid fatigue effects and reduce the impact of within-day fluctuations of vigilance, a break of 30 to 80 min between each assessment was taken.
Masking: Single (Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: coma; disorder of consciousness; behavioral scale; rehabilitation; diagnosis
Antithrombotic Activities of a Novel Yoghurt Drink: a Postprandial Study
Condition: Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      The project aims to investigate the antithrombotic activity of the novel yoghurt drink
      enriched with polar lipids derived from ovine milk. The health claims the formulated novel or
      functional food on EFSA guidelines "The scientific requirements for health claims related to
      antioxidants, oxidative damage and cardiovascular health" and in a particular paragraph 5.4,
      "Claims on reduced platelet aggregation" "Platelet hyperactivity and hypercoagulability
      states are more commonly observed in subjects with cardiovascular (CV) risk factors. Healthy
      subjects or participants at very low risk of CV disease normally have non-activated
      circulating platelets. Reducing platelet aggregation in subjects with platelet activation
      during sustained exposure to the food/constituent (e.g., four weeks) would be a beneficial
      physiological effect".

      Within this investigation, the postprandial effects of this novel yoghurt drink against
      platelet aggregation are going to be studied ex vivo in blood from healthy human subjects as
      described in previously established procedures.
    


Intervention name(s): Novel yoghurt drink containing Polar Lipids
Intervention type(s): Dietary Supplement
Intervention description(s): Postprandial decreased platelet activation/aggregation in subjects, after the yoghurt drink consumption
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention