bioihbjkbjnl/mcl2 huggingface dataset:
Antiretroviral Therapy and Extreme Weight
Condition: HIV Infection
MeSH terms: HIV Infections
Study type: Observational

Summary: 
      The concentration of the third agent in antiretroviral therapy [Non Nucleoside Reverse
      Transcriptase Inhibitor (NNRTI), or boosted Protease inhibitor (PI) ] is different according
      to the body weight or body composition and therapeutic monitoring may be necessary in
      overweight HIV patients.

      The investigators aim at measuring the individual trough concentrations of interest [at
      steady state for NNRTI and boosted PI] in overweight and normal weight HIV+ patients.
    

Detailed description: 
      Our primary endpoint is the individual trough concentrations of interest at steady state for
      NNRTI or boosted PI; Principal outcome measure: comparison of the concentrations between
      patients <25kg/m2 and patients<25kg/m2

      Secondary endpoints:

        -  Occurrence of virologic failure

        -  Occurrence of clinical/biological adverse events

        -  Percentage of patients with concentration within the therapeutic range

        -  Body composition Secondary outcome measures: comparison of the occurrence of virologic
           failure, occurrence or adverse event, patients with concentration within the therapeutic
           range between groups. Correlation between body composition and concentration.

      Methodology, study design:

      open-labelled monocentric study.

      Sample size:

      It will be a descriptive experimental study involving 120 overweight subjects, 120 normal
      weight subjects

      Inclusion criteria :

        -  Patients with HIV+

        -  Patients aged more than 18 years old.

        -  Patient giving its well-informed and free consent.

      Study design :

      Plasma concentration was performed during the usual clinical follow-up. Study duration: 12
      months Duration for a patient: 1 day Investigating center and participating units: one center
      enrolling the patients and the lab performing drug dosages.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        HIV-infected patients aged 18 years and older, treated with either efavirenz, atazanavir,
        or darunavir for at least 4 weeks and under stable treatment regimen
      
Keywords: trough concentration; weight; HIV; virological failure
Clinical Comparative Study of Personalized Shoulder, Knee and Ankle Brace
Condition: Shoulder Injuries; Knee Injuries; Ankle Injuries
MeSH terms: Wounds and Injuries; Knee Injuries; Ankle Injuries; Shoulder Injuries
Study type: Interventional

Summary: 
      This study is based on human anatomical data and uses computer-aided engineering (CAE)
      software such as biomedical image processing software, reverse engineering software, CAD
      software, and finite element analysis software to create a three-dimensional bracing model.
      With the help of 3D printing technology, we have developed personalized brace, completed the
      personalized rapid design and optimization of the three series of support equipment products
      such as the posterior cruciate ligament brace, ankle ankle brace, and shoulder brace.
    

Detailed description: 
      The traditional brace mainly includes small splints or gypsums. The manufacturing process is
      rough, and the flexibility is poor. In recent years, with the development of orthopedic
      surgery, rehabilitation concept, modern polymer materials, and biomechanics, great progress
      has been made in R&D, production, and assembly of orthoses. In developed countries, orthoses
      is not only widely used after orthopedic surgery and the department of rehabilitation, but it
      has become the main auxiliary device for sports trauma surgery, immobilization, treatment,
      and rehabilitation training. Leading bracing company such as DJO has developed multi-brand
      correction devices such as Aircast®, Chattanooga, CMF, COMPEX®, DonJoy®, Empi® and ProCare®.
      However, these braces are not designed and manufactured based on patients. Individually
      designed products for anatomical structures still have many problems in clinical
      applications.
    

Intervention name(s): Rehabilitation brace
Intervention type(s): Device
Intervention description(s): Rehabilitation brace
Other intervention name(s): Individualized rehabilitation support
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Personalized; brace; shoulder; knee; ankle
Imipramine on ER+ve and Triple Negative Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Comparing changes in biomarkers from a diagnostic core needle biopsy to surgical pathology
      specimen or repeat core needle biopsy.
    

Detailed description: 
      This will be a single arm, non-randomized, pre-surgical clinical trial of women with newly
      diagnosed triple negative breast cancer comparing changes in biomarkers from a diagnostic
      core needle biopsy to surgical pathology specimen or repeat core needle biopsy.
    

Intervention name(s): Imipramine
Intervention type(s): Drug
Intervention description(s): Imipramine will be given daily for 21-30 days.
Intervention MeSH terms: Imipramine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Diagnostic Validity of the Neurodynamic or Orthopedic Tension Tests
Condition: Radiculopathy, Lumbosacral Region
MeSH terms: Radiculopathy
Study type: Observational

Summary: 
      The objective of the present study is to analyse the diagnostic validity of 8 neurodynamic
      and/or orthopedic tension tests using magnetic resonance imaging as the Gold Standard.
    

Detailed description: 
      Lumbar radiculopathy is a nerve root disorder which affects quality of life of the patient
      and it is considered as an important health problem. Therefore, its correct diagnosis is
      essential. The objective of the present study is to analyse the diagnostic validity of 8
      neurodynamic and/or orthopedic tension tests using magnetic resonance imaging as the Gold
      Standard.

      This is an epidemiological study of randomized consecutive cases which was observational,
      descriptive, transversal, double blinded and followed the STARD (Standards for Reporting
      Diagnostic accuracy studies) declaration.
    

Intervention name(s): Straight Leg Raise test (SLR) and Bragard test (B); Fajersztajn test (F) and Sicard test (S); Passive Neck Flexion test (PNF)and Kernig test (K); Slump test (ST) and Dejerine triad (DT); MRI scan
Intervention type(s): Diagnostic Test; Diagnostic Test; Diagnostic Test; Diagnostic Test; Diagnostic Test
Intervention description(s): The following neurodynamic and/or orthopedic tension tests were done: the Straight Leg Raise test (SLR), the Bragard test (B) and another test which was the combined test of both (SLR+B); The following neurodynamic and/or orthopedic tension tests were done: the Fajersztajn test (F), the Sicard test (S) and another test which was the combination of both (F+S); The following neurodynamic and/or orthopedic tension tests were done: the Passive Neck Flexion test (PNF), the Kernig test (K) and another test which was the combination of both (PNF+K); The following neurodynamic and/or orthopedic tension tests were done: the Slump test (ST), the Dejerine triad (DT) and another test which was the combination of both (ST+DT); All participants will undergo a MRI scan to compare results between the index tests and the Gold Standard
Other intervention name(s): Index tests; Index tests; Index tests; Index tests; Gold Standard
Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The target population were all the patients referred to the Radiology Department of the
        'Puerta del Mar University Hospital' in Cádiz (Spain) to undertake a MRI scan of the lumbar
        or lumbosacral spine
      
Keywords: Lumbar radiculopathy; Neurodynamic tension tests; Orthopaedic tension tests; Lumbosacral radiculopathy
Postoperative Analgesic Effect of Nefopam
Condition: Stomach Neoplasms
MeSH terms: Stomach Neoplasms
Study type: Interventional

Summary: 
      Nefopam will be administered to the patients undergoing laparoscopic gastrectomy under the
      total intravenous anesthesia (TIVA).

      The investigators will evaluate whether the nefopam can decrease the total amount of
      remifentanil administered during the operation, which will reduce the acute opioid tolerance
      and following consumption of fentanyl during postoperative period.
    


Intervention name(s): Nefopam; Saline
Intervention type(s): Drug; Drug
Intervention MeSH terms: Nefopam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Study to Evaluate Whether BLI-489 Can be Safely Tolerated by Healthy Subjects Given Multiple Doses
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To determine the safety, tolerability, and drug absorption profile of multiple IV doses of
      BLI 489 in healthy subjects.
    


Intervention name(s): BLI-489; placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: BLI-489
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Keywords: Healthy Subjects
Supplemental Oxygen in Vascular Surgery
Condition: Surgical Wound Infection; Vascular Surgery
MeSH terms: Infections; Wound Infection; Surgical Wound Infection; Surgical Wound
Study type: Interventional

Summary: 
      The purpose of this study was to test the hypothesis that supplemental postoperative oxygen
      reduces the risk of surgical wound infection in patients following lower limb vascular
      surgery.
    


Intervention name(s): supplemental postoperative oxygen
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Diabetes Remission After RYGBP and RYGBP With Fundus Resection
Condition: Type 2 Diabetes; Morbid Obesity; Bariatric Surgery
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Obesity, Morbid
Study type: Interventional

Summary: 
      The goal of this randomized clinical trial is to evaluate glycemic control in patients with
      morbid obesity and type 2 diabetes after Roux-en-Y gastric bypass (RYGBP) and RYGBP with
      fundus resection. The main questions to answer are:

        -  Rate of diabetes remission and the role of the gastrointestinal hormones

        -  Whether fundus resection leads to improved glycemic control

      Patients will randomly undergo typical RYGBP or RYGBP with fundus resection. Gastrointestinal
      hormones profile [ghrelin, glucagon-like peptide-1 (GLP-1), peptide YY (PYY), glucagon],
      glucose levels and insulin response will be measured preoperatively, at 6 months and at 12
      months, during 120-min OGTT.
    


Intervention name(s): Laparoscopic Roux en Y gastric bypass; Laparoscopic Roux en Y gastric bypass with fundus resection
Intervention type(s): Procedure; Procedure
Intervention description(s): Laparoscopic RYGBP included the creation of a small gastric pouch, with a 200cm biliopancreatic limb and a 150cm alimentary limb.; Laparoscopic RYGBP included the creation of a small gastric pouch, with a 200cm biliopancreatic limb and a 150cm alimentary limb. Fundus resection is further applied in this arm.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Gastric Fundus; Gastrointestinal Hormones
Study of Factors Predicting Tumor Recurrence After Liver Transplantation for Hepatocellular Carcinoma (HCC)
Condition: Hepatocellular Carcinoma; Liver Cirrhosis; Evidence of Liver Transplantation
MeSH terms: Carcinoma; Carcinoma, Hepatocellular; Liver Cirrhosis; Fibrosis; Recurrence
Study type: Observational

Summary: 
      Results of liver transplantation, the best theoretical treatment for HCC, are limited by
      tumor recurrence. In order to limit this risk Milan criteria was proposed in 1996. However,
      these criteria are to restrictive and approximately 40% of patients denied by Milan criteria
      may be cured by liver transplantation.

      The purpose of this study was thus to prospectively evaluate factors predicting tumor
      recurrence after liver transplantation for HCC and then to reassess criteria for liver
      transplantation.
    

Detailed description: 
      In this study, the investigators studied the predictive value of imaging techniques such as
      CT, MRI, PET scan, of serological markers and molecular markers assessed before liver
      transplantation at listing.

      The investigators also evaluated the predictive value of tumor growing during the waiting
      time (imaging and serological).

      Finally, the investigators compared pre-LT data and explanted liver analysis to evaluate
      accuracy of liver biopsy and of imaging.
    

Intervention name(s): search of factors predicting tumor recurrence
Intervention type(s): Other
Intervention description(s): Morphological, chronological, anatomy-pathological and molecular search
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patient notified on the waiting list for hepatic transplant
      
Biospecimen description: 
      Blood and serum sample (28 ml at M0, M3, M6) Tissues (one pretransplant, hepatic explant,
      potential resection)
    
Keywords: Hepatocellular carcinoma; Cirrhosis; Transplantation
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK8266 in Hypertensive Men (MK-8266-002)
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      This study evaluated adverse events (AEs), study discontinuation due to AEs, and
      pharmacodynamics of MK-8266 in male participants with mild to moderate hypertension.
    

Detailed description: 
      This study evaluated AEs, discontinuation due to AEs, and effects on hemodynamic parameters,
      including systolic blood pressure (SBP) and aortic augmentation index (AIx), following
      multiple oral doses of MK-8266. Five serial panels, each consisting of eight participants (40
      participants in Panels A, B, C, D, and E), were randomized to receive either MK-8266 or
      matching placebo twice daily (BID) or three times daily (TID) for 10 consecutive days.
      Although the original plan was to evaluate MK-8266 treatment in Panels D and E using both BID
      and TID regimens, the study actually evaluated identical TID regimens in these panels.
    

Intervention name(s): MK-8226 BID, 1 mg; MK-8266 BID, 1.8 mg; MK-8266 TID, 1.8 mg; MK-8266 TID, 2.4 mg; MK-8266 TID, 2.4 mg; Placebo BID (Panel A); Placebo BID (Panel B); Placebo TID (Panel C); Placebo TID (Panel D); Placebo TID (Panel E)
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): MK-8266 1 mg administered as oral capsules (0.7 mg + 0.3 mg), BID for 10 consecutive days. Panel A was completed prior to initiation of Panel B.; MK-8266 1.8 mg administered as oral capsules (1 mg + 0.8 mg), BID for 10 consecutive days. Panel B was completed prior to initiation of Panel C.; MK-8266 1.8 mg administered as oral capsules (0.6 mg), TID for 10 consecutive days. Panel C was completed prior to initiation of Panel D.; MK-8266 TID (Panel D), 2.4 mg administered as oral capsules (0.8 mg), TID for 10 consecutive days. Panel D was completed prior to initiation of Panel E.; MK-8266 TID (Panel E), 2.4 mg administered as oral capsules (0.8 mg), TID for 10 consecutive days. Panel E was initiated after completion of Panel D.; Placebo administered as oral capsules BID for 10 consecutive days. Panel A was completed prior to initiation of Panel B.; Placebo administered as oral capsules BID for 10 consecutive days. Panel B was completed prior to initiation of Panel C.; Placebo administered as oral capsules TID for 10 consecutive days. Panel C was completed prior to initiation of Panel D.; Placebo administered as oral capsules TID for 10 consecutive days. Panel D was completed prior to initiation of Panel E.; Placebo administered as oral capsules TID for 10 consecutive days. Panel E was initiated after completion of Panel D.
Other intervention name(s): MK-8266; MK-8266; MK-8266; MK-8266; MK-8266
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Hypertension
Efficacy of Different Acid Suppressors in Bismuth-containing Quadruple Therapy Against Helicobacter Pylori
Condition: Helicobacter Pylori; Eradication Rate
Study type: Observational

Summary: 
      Ａretrospective study was conducted to compare the efficacy, safety, and cost-effectiveness of
      traditional proton pump inhibitors (PPI ) and Potassium-competitive acid blockers ( P-CAB
      )for clarithromycin-based bismuth-containing quadruple therapy in the management of
      Helicobacter pylori eradication.
    

Detailed description: 
      This study retrospectively enrolled participants with H. pylori infection who received
      bismuth quadruple regimen containing clarithromycin. The basic information, treatment
      results, adverse reactions and compliance of the patients were collected. According to the
      type of acid inhibitors, participants were divided into traditional PPI group and P-CAB
      group. Traditional PPI group which were divided into lansoprazole group and esomeprazole
      group. The eradication rate, safety, compliance of H. pylori in different treatment regimens
      was evaluated. Multivariate analysis was performed to identify predictors of eradication
      failure.
    

Intervention name(s): PPI regimen; P-CAB regimen
Intervention type(s): Other; Other
Intervention description(s): All patients received PPI regimen( lansoprazole or esomeprazole,bismuth amoxicillin,clarithromycin for14 days). Demographic data,treatment regimens, outcomes of therapy, adherence to therapy and adverse event were retrieved.; All patients received P-CAB regimen(vonoprazan,bismuth ,amoxicillin,clarithromycin for14 days). Demographic data,treatment regimens, outcomes of therapy, adherence to therapy and adverse event were retrieved.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        helicobacter infection
      
Keywords: Helicobacter pylori,eradication therapy
Study of Ozanimod (RPC1063) in Relapsing Multiple Sclerosis (MS)
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether ozanimod is effective in the treatment of
      relapsing multiple sclerosis (RMS).
    


Intervention name(s): Ozanimod; Interferon beta-1a; Placebo to ozanimod; Placebo to interferon beta-1a
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Capsules for oral administration once a day; Administered by intramuscular injection once a week; Matching placebo capsules administered orally once a day; Placebo intramuscular injection once a week
Other intervention name(s): RPC1063; Zeposia®; Avonex®; IFN β-1a
Intervention MeSH terms: Interferons; Interferon-beta; Interferon beta-1a; Ozanimod
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: MS; RMS; Multiple Sclerosis; Relapsing Multiple Sclerosis
A Phase 3, 12-week, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy, Safety, and Tolerability of 2 Fixed Doses of Brexpiprazole in the Treatment of Alzheimer's Agitation
Condition: Agitation Associated With; Alzheimer's Disease; Alzheimer's Type; Mental Disorder; Nervous System Diseases
MeSH terms: Alzheimer Disease; Psychomotor Agitation; Nervous System Diseases; Mental Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      To compare the efficacy of 2 fixed doses of brexpiprazole with placebo in participants with
      agitation associated with dementia of the Alzheimer's type.
    

Detailed description: 
      Behavioral symptoms, such as agitation, are core features in participants with Alzheimer's
      disease and related dementias and develop in the majority of dementia participants. The
      presence of agitation in participants with Alzheimer's disease places a significant burden
      not only on participants and their caregivers but also on the healthcare system.

      This is a trial designed to assess the safety and efficacy of brexpiprazole in the treatment
      of participants with agitation associated with dementia of the Alzheimer's Type. The trial
      consists of a continuous 12-week double-blind treatment period with a 30-day follow-up. The
      trial population will include male and female participants between 55 and 90 years of age
      (inclusive) with a diagnosis of probable Alzheimer's disease, who are residing either in an
      institutionalized setting or in a non-institutionalized setting where the participant is not
      living alone.
    

Intervention name(s): Brexpiprazole, OPC-34712; Placebo Oral Tablet
Intervention type(s): Drug; Drug
Intervention description(s): Once-daily, tablets; Once-daily, tablets
Intervention MeSH terms: Brexpiprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: OPC-34712; brexpiprazole; Dementia; Alzheimer's Disease; Cognitive Disorders; Agitation
Effect of Inhaled Ciclesonide Versus Fluticasone Propionate in Patients With Mild to Moderate Asthma (18 to 65 y) (BY9010/M1-129)
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of the study is to investigate the effect of ciclesonide versus fluticasone
      propionate versus placebo on airway hyperresponsiveness and on the
      hypothalamic-pituitary-adrenal axis (HPA axis). Treatment medication will be administered as
      follows: ciclesonide or fluticasone propionate will be inhaled twice daily, using one of the
      two dose levels. The study duration consists of a baseline period (4 to 6 weeks), five
      treatment periods (9 days each), and a washout period between treatments (4 to 12 weeks). The
      study will provide further data on safety and tolerability of ciclesonide.
    


Intervention name(s): Ciclesonide
Intervention type(s): Drug
Intervention MeSH terms: Ciclesonide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Asthma; Ciclesonide; Fluticasone propionate