bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Cost-effectiveness Study of Single Port Laparoscopic Cholecystectomies
Condition: Cholecystolithiasis
MeSH terms: Cholecystolithiasis; Cholelithiasis; Gallstones
Study type: Interventional

Summary: 
      Many feasibility studies have been published on Single Port surgery, but no comparative
      studies have shown any advantages compared to standard laparoscopy. The purpose of this study
      is to compare the clinical outcomes and economical issues of laparoscopic cholecystectomies
      using single port transumbilical approach and three trocars.
    

Detailed description: 
      Design:

        -  Prospective Randomized Controlled trial

        -  Population analysis based on Intention To Treat

        -  Patient and data analyzer blinded (double-blind trial)

      Outcomes observed:

        -  Primary: pain

        -  Secondaries: overall operative time, complication rate, cost-effectiveness analysis,
           cosmetic evaluation, quality of life, CO2 consumption

      Nbr of patients included: 260

      Port used: Triport, Olympus
    

Intervention name(s): Single Trocar CCK; Standard CCK
Intervention type(s): Procedure; Procedure
Intervention description(s): CCK using Triport; CCK using three or four ports
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cholecystolithiasis; Cholecystectomy; Laparoscopic surgery; Single port
Achilles Tendon Rupture, Comparison Two Different Operative Techniques. Prospective Randomized Controlled Trial. 14 Years Follow-up.
Condition: Achilles Tendon Rupture
MeSH terms: Rupture
Study type: Interventional

Summary: 
      The intention is to compare 60 patients with Achilles tendon rupture, who where randomized in
      1998-2001 preoperatively to receive end-to-end suturation by the Krackow locking loop
      technique either without augmentation or with one central down-turned gastrocnemius fascia
      flap (Silfverskjöld). Postoperative care was identical for both groups; A brace allowed free
      active plantar flexion of the ankle postoperatively, whereas dorsiflexion was restricted to
      neutral for the first three weeks. Weight bearing was limited for six weeks. To compare these
      treatments, we use 1998 published Leppilahti-score, Rand-36 quality of life-questionnaire and
      MRI. Mean follow-up time is 14 years.

      Hypothesis; Augmentation with a down-turned gastrocnemius fascia flap does not provide better
      result than would end-to-end suture repair with use of the Krackow locking loop surgical
      technique in long-term follow up.
    


Intervention name(s): End-to-end suturation without augmentation; End-to-end suturation with augmentation.
Intervention type(s): Procedure; Procedure
Intervention description(s): End-to-end suturation without augmentation; Irregular tendon ends were cleaned and repaired by the Krackow technique with two separate 0-gauge absorbable sutures.; End-to-end suturation with augmentation; End-to-end suturation as above with a 10 mm wide central gastrocnemius aponeurosis flap, as proposed by Silfverskjöld.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Achilles tendon rupture, operative treatment, elongation, long-term follow up.
Effect of Velphoro on Serum Phosphate and Albumin in Peritoneal Dialysis Patients
Condition: Peritoneal Dialysis Complication; Hyperphosphatemia; Hypoalbuminemia
MeSH terms: Hypoalbuminemia; Hyperphosphatemia
Study type: Interventional
Phase: Phase 4

Summary: 
      Prospective pilot study to determine if changing the phosphate binder to sucroferric
      oxyhydroxide for for 6 months improves disordered mineral metabolism and nutrition status in
      peritoneal dialysis patients.
    


Intervention name(s): Sucroferric Oxyhydroxide Chewable Tablet
Intervention type(s): Drug
Intervention description(s): Patients will be started on 1 tablet three times daily with meals and the dose will be titrated monthly in increments of 500mg (1 tablet) per day until serum phosphate is at goal
Intervention MeSH terms: Ferric Compounds
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
High MAP in Septic Shock With Hypertension
Condition: Septic Shock
MeSH terms: Shock, Septic; Hypertension; Shock
Study type: Interventional

Summary: 
      We hypothesized that the increase in MAP from 65 mmHg to patients' usual level improved
      sublingual microcirculation.
    

Detailed description: 
      The effect of mean arterial pressure (MAP) titration to higher level on microcirculation in
      septic shock patients with previous hypertension remains unknown. Our goal was to assess the
      effect of MAP titration to patients' usual level on microcirculation in septic shock patients
      with previous hypertension. We hypothesized that the increase in MAP from 65 mmHg to
      patients' usual level improved sublingual microcirculation.
    

Intervention name(s): NE
Intervention type(s): Other
Intervention description(s): norepinephine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: septic shock; microcirculation; norepinephrine; fluid
Effects of a Large Increase in Dietary Fats and Cholesterol on HDL Composition and Function in Healthy Subjects
Condition: Lipids
Study type: Interventional

Summary: 
      In this study the investigators aimed at measuring the effect of a two-week
      high-fat/high-cholesterol (HFHC) normocaloric diet on HDL particles biochemical composition
      and HDL function compared to a two-week low-fat/low-cholesterol (LFLC) normocaloric diet.
    

Detailed description: 
      HDL particles can change their composition and function in response to a variety of
      pathological conditions and environmental stimuli. It has been previously shown that a
      western diet is able to drastically modify biochemical composition, anti-inflammatory and
      anti-oxidant properties of HDL in animals. In humans little is known on the role of diet on
      HDL function and composition.
    

Intervention name(s): Low fat/cholesterol diet; High fat/cholesterol diet
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): The low fat/cholesterol diet had 10% calories from fat and 150-200 mg of cholesterol per day.; The high fat/cholesterol diet had 40% calories from fat and 250-300 mg of cholesterol per day
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: HDL biochemical composition and function
Denosumab in Combination With Chemotherapy as First-line Treatment of Metastatic Non-small Cell Lung Cancer
Condition: Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 2

Summary: 
      This randomized phase 2 trial is studying the effect of adding denosumab to standard
      chemotherapy in the treatment of advanced lung cancer.
    

Detailed description: 
      This is a global randomized double-blind placebo-controlled study in patients with Stage IV
      untreated non-small cell lung cancer (NSCLC) with or without bone metastasis. Eligible
      participants are to receive 4 to 6 cycles of a standard of care platinum-doublet chemotherapy
      regimen. Participants will be randomized in a 2:1 ratio to receive denosumab or matching
      placebo with the first investigational product dose coinciding with participant's first cycle
      of chemotherapy and continuing until the primary analysis, unacceptable toxicity, withdrawal
      of consent, death, or lost to follow-up. Participants who discontinued the investigational
      product early (ie, before primary analysis) were followed for disease status and survival.
      The primary analysis took place when 149 events of death had been reported. All participants
      were followed for 2 years after the last dose of blinded investigational product.
    

Intervention name(s): Denosumab; Zoledronic acid; Placebo to Denosumab; Standard Chemotherapy; Placebo to Zoledronic Acid
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Administered by subcutaneous injection once every 4 weeks (Q4W) plus one loading dose on study day 8; could be administered as often as every 3 weeks (Q3W) to participants receiving Q3W chemotherapy.; Administered by intravenous infusion in participants with bone metastasis upon investigative site request for IV bone-targeted therapy.; Administered by subcutaneous injection once every 4 weeks (Q4W) plus one loading dose on study day 8; could be administered as often as every 3 weeks (Q3W) to participants receiving Q3W chemotherapy.; Standard of care chemotherapy consisting of pemetrexed or gemcitabine in combination with cisplatin or carboplatin administered according to local practice.; Administered by intravenous infusion in participants with bone metastasis upon investigative site request for IV bone-targeted therapy.
Other intervention name(s): XGEVA; Zometa
Intervention MeSH terms: Zoledronic Acid; Denosumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The Effect Of Fesoterodine On Pharmacokinetics And Pharmacodynamics Of Warfarin In Healthy Subjects
Condition: Urinary Bladder, Overactive
MeSH terms: Urinary Bladder, Overactive
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, randomized, two-way crossover study to evaluate the steady-state
      effect of fesoterodine (8 mg QD) on the pharmacodynamics and pharmacokinetics of a single
      supratherapeutic dose of warfarin (25 mg) in healthy subjects.
    


Intervention name(s): warfarin; Warfarin plus Fesoterodine
Intervention type(s): Drug; Drug
Intervention description(s): Single Dose Warfarin 25 mg on Day 1; Fesoterodine 8 mg ER tablets QD for 9 Days and Single Dose Warfarin 25 mg on Day 3
Intervention MeSH terms: Warfarin; Fesoterodine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Overactive Bladder Urgency Frequency
Management of Abdominal Pain in Acute Gastroenteritis Patients With Hyoscine Butylbromide
Condition: Acute Gastroenteritis; Abdominal Pain
MeSH terms: Gastroenteritis; Abdominal Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      One of the most common complaints of admission to the emergency room is gastroenteritis. One
      of the most common complaints in acute gastroenteritis is abdominal pain. The aim of our
      study is to investigate whether hyoscine butylbromide used within the indication has an
      effect on abdominal pain due to acute gastroenteritis. The main purpose of our study is to
      reduce the pain of the patient at 30th and 60th minutes compared to 0th minute.
    


Intervention name(s): Hyoscine N Butylbromide; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Hyoscine N butylbromide injection for the treatment of abdominal pain in acute gastroenteritis; 2 ml of normal saline injection as placebo
Intervention MeSH terms: Scopolamine; Butylscopolammonium Bromide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The Effects of Botulinum Toxin on Oral Aperture in Patients With Scleroderma
Condition: Scleroderma
MeSH terms: Scleroderma, Systemic; Scleroderma, Diffuse; Scleroderma, Localized
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This study will evaluate the use of botulinum toxin for microstomia (also known as reduced
      oral aperture) in scleroderma patients. Botox is a neurotoxin that functions as a paralytic
      by preventing the release of acetylcholine to inhibit muscle contracture and decrease
      fibrosis by decreasing differentiation of fibroblasts to myofibroblasts, decreasing
      expression of collagen, and increasing expression of matrix metalloproteinase1-3. The study
      will include three arms: the temporomandibular joint (TMJ) group who will receive injections
      of Botox to the masseter, the perioral group who will receive injections of Botox around the
      lips, and a control group who will receive no treatment for ROA. Outcome measurements will
      include measurement of oral aperture size through measurement inter-labial distance and
      between the upper and lower lips and the inter-incisal distance, patient satisfaction via a
      Skindex16 survey, mouth disability via the Mouth Handicap in Systemic Sclerosis Scale
      (MHISS), and patient and physician satisfaction using the Visual Analogic Scale (VAS). The
      maximum number of subjects to be consented for this study is 30. The study is expected to
      last four months per subject from time of consent to last clinical evaluation. Conditions
      that may result in a subject exiting the study prior to completion date include
      non-compliance, withdrawal of consent, or safety concerns such as adverse events as a result
      of treatment.
    


Intervention name(s): Botulinum toxin(Botox)
Intervention type(s): Biological
Intervention description(s): This study will evaluate the use of botulinum toxin for reduced oral aperture in scleroderma patients. Botox is a neurotoxin that functions as a paralytic by preventing the release of acetylcholine to inhibit muscle contracture and decrease fibrosis by decreasing differentiation of fibroblasts to myofibroblasts, decreasing expression of collagen, and increasing expression of matrix metalloproteinase.
Intervention MeSH terms: Botulinum Toxins
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2/COVID-19) Neutralizing Antibody in Healthy Participants
Condition: Covid19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to investigate the safety and tolerability of BGB-DXP593
      administered intravenously as a single dose in healthy participants
    


Intervention name(s): BGB DXP593; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered intravenously (IV) as specified in the treatment arm; Placebo to match BGB-DXP593
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
A Study of Etripamil in Healthy Subjects
Condition: Healthy Chinese Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The objectives of the study are as below:

      Primary:

      ·To evaluate the pharmacokinetics (PK) of Etripamil in healthy adult Chinese subjects

      Secondary:

        -  To evaluate the pharmacodynamics (PD) of Etripamil in healthy adult Chinese subjects

        -  To evaluate the safety and tolerability of Etripamil in healthy adult Chinese subjects

      Exploratory:

      ·To evaluate the PK exposure-PD response relationship of etripamil in healthy adult Chinese
      subjects
    

Detailed description: 
      This is a randomized, double-blind, placebo-controlled phase 1 study in healthy adult Chinese
      subjects to evaluate the PK, PD, safety and tolerability of single dose of etripamil, 70 mg
      nasal spray (NS). After signing the informed consent form (ICF), potential subjects will
      undergo screening procedures within 28 days prior to dosing. Eligible subjects will be
      admitted to the clinical unit on Day -1 and screening procedures will be repeated to confirm
      eligibility. Subjects will fast overnight for at least 10 hours prior to dosing. 12 healthy
      adult Chinese subjects will be randomized to receive etripamil 70 mg single dose (n=10) or
      placebo (n=2).

      Blood and urine samples will be collected for PK assessments of etripamil and the inactive
      main metabolite MSP-2030.

      AEs, 12-lead ECGs, clinical laboratory tests, vital signs, physical examinations, and
      concomitant medications will be collected and evaluated over the course of study.

      Subjects will remain in clinic until discharged on Day 2. There will be a follow-up telephone
      call on Day 11 (±1 day) of dosing. Total duration for each subject will be approximately 1.5
      months.
    

Intervention name(s): Etripamil Nasal Spray 70mg; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Etripamil NS 70 mg will be administered via the Aptar Pharma Nasal Spray Bidose System, supplied as prefilled devices packaged into child-resistant boxes with instructions for use provided in the study drug box.; Placebo will be administered via the Aptar Pharma Nasal Spray Bidose System, supplied as prefilled devices packaged into child-resistant boxes with instructions for use provided in the study drug box.
Intervention MeSH terms: Etripamil
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A Single Center, Randomized, Double-Blind, Placebo-Controlled Phase 1 Study
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Etripamil; Paroxysmal supraventricular tachycardia; Tachycardia; Tachycardia, Supraventricular
BMS-562247 in Subjects Undergoing Elective Total Knee Replacement Surgery
Condition: Venous Thrombosis; Pulmonary Embolism
MeSH terms: Pulmonary Embolism; Thrombosis; Embolism; Venous Thrombosis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to learn if BMS-562247 can prevent blood clots in the legs and
      lungs in men and women following unilateral total knee replacement surgery. The safety of
      this treatment will also be studied.
    


Intervention name(s): Apixaban; Enoxaparin; Warfarin; Enoxaparin Placebo; Apixaban Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Tablets, Oral, 12 +/- 2 days; Injection, SQ, Q12H, 12 +/- 2 days; Tablets, Oral, QD, 12 +/- 2 days; Injection, SQ, BID, 12 +/- 2 days; Tablets, Oral, BID, 12 +/- 2 days
Other intervention name(s): BMS-562247
Intervention MeSH terms: Enoxaparin; Warfarin; Enoxaparin sodium; Apixaban
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Prevention of deep vein thrombosis and pulmonary embolism; Preventive therapy
Taxol Epirubicin Cyclophosphamide Herceptin Neoadjuvant (TECHNO)
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The present clinical trial will investigate the safety and efficacy of a sequential
      preoperative therapy with Epirubicin/Cyclophosphamide in combination with
      Paclitaxel/Trastuzumab, followed by postoperative Trastuzumab in patients with HER-2
      overexpression primary breast cancer.
    


Intervention name(s): Epirubicin / Cyclophosphamide in combination with Paclitaxel/Trastuzumab, followed by postoperative Trastuzumab
Intervention type(s): Drug
Intervention description(s): Cycles 1-4 Epirubicin: 90 mg/m2, i.v. day 1 Cyclophosphamide: 600 mg/m2, i.v. day 1 Every 22d
Cycles 5-8 Paclitaxel: 175 mg/m2, i.v., 3h-infusion day 1 Trastuzumab: 8 mg/kg i.v. at day 0 of the 5th cycle and thereafter each 6 mg/kg i.v. day 1 in the cycles 6-8 Every 22d
Intervention MeSH terms: Paclitaxel; Cyclophosphamide; Trastuzumab; Epirubicin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Safety and efficacy of experimental treatment
An mHealth Intervention to Improve Medication Adherence and Health Outcomes
Condition: Coronary Heart Disease
MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia
Study type: Interventional

Summary: 
      Investigators evaluated the efficacy of a pilot-tested mHealth intervention to improving
      medication adherence and health outcomes among patients with coronary heart disease.
    

Detailed description: 
      This was a two-arm parallel randomized controlled trial, in which 116 and 114 participants
      were assigned to the experimental and control groups, respectively. The mHealth intervention
      in this study had been pilot tested and tailored. Specifically, the experimental group
      received a medication-taking reminder every morning via WeChat app and educational materials
      of coronary heart disease and medication adherence every five days via Message Express app.
      The control group received only general educational materials, which were irrelevant to
      coronary heart disease or medication adherence, every 5 days via Message Express app. All
      participants were diagnosed with coronary heart disease. The specific recruitment criteria of
      participants had been published in peer-reviewed journal.
    

Intervention name(s): Medication-taking reminders & educational materials; Educational materials
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The intervention has been described in arm/group descriptions, which lasted for 60 days for each participants.; The intervention has been described in arm/group descriptions, which lasted for 60 days for each participants.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Heart Rate Variability During Acute Diverticulitis
Condition: Acute Diverticulitis
MeSH terms: Diverticulitis
Study type: Observational

Summary: 
      The purpose of this study is to investigate heart rate variability during Acute uncomplicated
      diverticulitis by ECG-monitor (Holter), the investigators hypothesis is the inflammation
      causes a decrease of High Frequency(HF)-power component of heart rate variability and this
      correlates with sleep quality and daytime fatigue.
    

Detailed description: 
      An increasing number of studies have shown that circadian variation in the excretion of
      hormones, the sleep-wake cycle, the core body temperature, the tone of the autonomic nervous
      system and the activity rhythm are important both in health and disease processes. The
      investigators are interested in investigating the heart rate variability (HRV) during an
      acute surgical non-inflammatory condition, and to exam whether there are correlations
      between: HRV and sleep stages, HRV and cytokine levels in blood and HRV and subjective
      fatigue.

      Following methods will be applied

      Device: Holter monitor - Medilog AR12 (Oxford Instruments, Oxford, England)

      Other: Karolinska Sleepiness Scale

      Other: Physical Fatigue Scale

      Device: Polysomnograph - Embla Titanium (Natus Medical Incorporated, USA)

      Procedure: Plasma cytokines (IL-2, IL-6 and TNF(tumor necrosis factor)-alfa)

      Procedure: Plasma CRP(C reactive protein) and leukocytes
    

Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        16 x Acute uncomplicated diverticulitis (Hansen and stock stage 1) patients aged 18-75
        years managed by antibiotic treatment at Herlev Hospital
      
Biospecimen description: 
      plasma