bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of Enhanced Recovery After Surgery in Endoscopic Sinus Surgery
Condition: Chronic Rhinosinusitis (Diagnosis); Surgery
MeSH terms: Sinusitis; Chronic Disease
Study type: Interventional

Summary: 
      Enhanced recovery after surgery (ERAS) protocols have been widely applied during
      perioperative periods for different diseases, there are few reports of ERAS in patients
      undergoing endoscopic sinus surgery (ESS). This study therefore aimed to evaluate the
      benefits of ERAS protocol compared to traditional care following ESS.
    


Intervention name(s): Flurbiprofen Axetil; Sufentanil; Extended perioperative counseling; Shorter fasting food and water time before surgery; Conventional perioperative counseling; Regular fasting food and water time before surgery
Intervention type(s): Drug; Drug; Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): One kind of NSAIDs, 200mg for 48 hours after surgery.; One kind of opioid drugs, 1.5μg/kg, and recorded the drug consumption after surgery; The extended perioperative counseling contained additional information, including surgery procedures, importance of medicine treatment and medical help to relieve depression and anxiety about disease during peri-operation period.; The patients in ERAS group were required to fast food for 6 to 8 hours and provided 12.6% maltodextrin carbohydrate supplement beverage for 2 hours before surgery; THe conventional perioperative counseling included the risk of surgery and prognosis of disease and other things patients need to know.; The stricter control of preoperative fasting requirements, prohibiting solids and liquids from previous midnight to operation time.
Intervention MeSH terms: Flurbiprofen; Flurbiprofen axetil; Sufentanil
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients with chronic rhinosinusitis undergoing ESS were prospectively assigned to one of five groups; ERAS groups with postoperative intravenous Flubiprofen Axetil or analgesia pump, traditional care with Flubiprofen Axetil or analgesia pump (NERAS groups), or traditional care without postoperative intravenous analgesia group (control).
Masking: None (Open Label)
Primary purpose: Supportive Care
A Clinical Trial of Anakinra for Steroid-Resistant Autoimmune Inner Ear Disease
Condition: Sensorineural Hearing Loss; Autoimmune Inner Ear Disease
MeSH terms: Hearing Loss; Deafness; Hearing Loss, Sensorineural; Ear Diseases; Labyrinth Diseases; Labyrinthitis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to determine if Anakinra (an interleukin-1 receptor antagonist)
      can improve hearing thresholds in those patients with Autoimmune Inner Ear Disease (AIED)
      that did not respond to oral steroid therapy for a sudden decline in hearing. The patients to
      be enrolled will have recently completed a course of oral steroids and demonstrated no change
      in their audiometric thresholds following corticosteroid therapy.
    

Detailed description: 
      Patients with immune mediated hearing loss (also known as autoimmune hearing loss) are
      typically treated with corticosteroids. Of those treated, approximately 60% respond, however,
      that response may be lost over time. Other therapies use to date have proven largely
      ineffectual in improving hearing. This study proposes a phase I open label clinical trial of
      Anakinra for corticosteroid-resistant patients to determine if this therapy is efficacious in
      hearing restoration.
    

Intervention name(s): Anakinra
Intervention type(s): Drug
Intervention description(s): 100mg of anakinra administered by a subcutaneous injection for 84 consecutive days.
Other intervention name(s): Kineret
Intervention MeSH terms: Interleukin 1 Receptor Antagonist Protein
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Steroid; Steroid-Resistant; Autoimmune Inner Ear Disease; Immune Mediated Hearing Loss; Sudden Sensorineural Hearing Loss; Meniere's Disease; Autoimmune; Hearing
Effect of Nutriose Supplementation on Satiety, Weight Loss and Adiposity in Overweight Subjects
Condition: Overweight
MeSH terms: Overweight; Weight Loss
Study type: Interventional
Phase: Phase 1

Summary: 
      NUTRIOSE is a food ingredient defined as a carbohydrate polymer of vegetable origin (wheat
      starch or corn) with a degree of polymerization ≥ 3 and chemically transformed. It is soluble
      in aqueous solution, very poorly digested in the small intestine, it mostly reaches the colon
      where it stimulates fermentation. AFSSA, in its opinion of July 30, 2007, considers that this
      ingredient is a "soluble dietary fiber." Recent work in China in overweight volunteers have
      shown an effect of NUTRIOSE on satiation and satiety, and demonstrate an effect on reducing
      weight and fat mass. By its action on satiety and reduced food intake, the NUTRIOSE be of
      interest in the management of overweight or obese. Among the possible mechanisms of action,
      are the metabolites produced by colonic fermentation of NUTRIOSE.

      The goal of this biomedical research is to study the effect of a dose of 14g/day of NUTRIOSE
      FB06 for 12 weeks on the evolution of weight, percentage of body fat and digestive tolerance
      in Caucasians overweight subjects. To gather evidence to support mechanisms of action, it is
      proposed to measure before consumption, then every 4 weeks, the effects of NUTRIOSE FB06 on
      satiety and satiation and changes in colonic flora and its metabolites.
    


Intervention name(s): NUTRIOSE FB06; GLUCIIDEX 21
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 14g/day NUTRIOSE FB06: 7g in 250 mL orange juice twice a day; 7g/day GLUCIDEX 21 : 3.5g in 250 mL orange juice twice a day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Keywords: overweight; satiety; functional food; food intake; digestive tolerance
Safety and Efficacy Study of TNX-102 SL in Subjects With Military-Related PTSD and Related Conditions
Condition: PTSD
MeSH terms: Disease; Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a 12-week, multicenter, randomized, double-blind, placebo-controlled, fixed-dose,
      parallel-group study that will investigate the efficacy and safety of two doses of TNX-102 SL
      -a sublingual formulation of cyclobenzaprine. Following successful screening and
      randomization, eligible subjects will return regularly to the study clinic for weekly or
      biweekly visits for assessments of efficacy and safety.
    


Intervention name(s): TNX-102 SL; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: PTSD; Military-related PTSD and other related conditions
Preventing Antibiotic-Associated DiarRhea Using Erceflora
Condition: Diarrhea, Infantile
MeSH terms: Diarrhea; Diarrhea, Infantile
Study type: Interventional
Phase: Phase 4

Summary: 
      To determine the effectiveness of the pre-biotic Bacillus clausii in preventing antibiotic
      associated diarrhea among hospitalized immunocompetent Filipino children.
    


Intervention name(s): Bacillus Clausii Multi ATB Resist; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Twice daily dose of 1 vial of 1x10^9 of Bacillus clausii spores, orally suspension in water; Matched placebo
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Novel Approach of Hayman Uterine Compression Sutures for Management of Severe Atonic Postpartum Hemorrhage: Three Vertical Sutures
Condition: Uterine Atony
MeSH terms: Postpartum Hemorrhage; Uterine Inertia; Hemorrhage
Study type: Observational

Summary: 
      Maternal deaths due to uterine atony bleeding are the leading causes of maternal death in our
      country and all over the world. In this respect, our clinic is among the clinics with the
      highest number of experience in our country and aims to reduce maternal deaths and mothers
      who will need intensive care due to bleeding with a hemorrhage stopping technique that will
      have a serious contribution to both our country and the world literature.

      Our primary goal, thanks to the bleeding-stopping technique, to reduce their deaths. Our
      secondary aim is, thanks to the bleeding-stopping technique we offer, To prevent and reduce
      the complications seen in mothers during the operative period.
    

Detailed description: 
      Our research was carried out to our obstetrics clinic between 01 Agustus 2015 - 01 December
      2020.

      Patients transplanted due to postpartum bleeding and patients requiring surgery due to
      abnormal postpartum bleeding in our clinic will be included. Patients with a previously known
      bleeding disorder will not be included in the study. In our study, the parameters of the
      patients who had bleeding due to postpartum uterine atony and who needed uterine surgery
      previously underwent triple Hayman compression suture to stop bleeding will be included in
      the study. Patients with a triple Hayman suture covering the upper 2/3 of the uterus to stop
      uterine bleeding will be evaluated in the study.
    

Intervention name(s): Patients with three vertical Hayman Sutures
Intervention type(s): Other
Intervention description(s): Patients who are referred to our clinic due to postpartum hemorrhage between the ages of 18-45 and who need to undergo a surgical procedure (not responding to medical treatment) due to abnormal uterine bleeding in our clinic will be included. Patients with a previously known diagnosis of bleeding and coagulation disorders will not be included in the study. Considering that we are one of the primary referral centers in Istanbul in terms of deliveries and post-partum bleeding in our hospital, it is aimed to terminate the study with approximately 50 participants.
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Patients with abnormal uterine bleeding other than birth Patients with known metabolic
        diseases Patients with known bleeding and coagulation disorders
A Phase 1, Randomized Pharmacokinetics and Safety Study of Extended Duration Dapivirine Vaginal Rings
Condition: HIV-1-infection
Study type: Interventional
Phase: Phase 1

Summary: 
      Participants will be randomized to one of three study vaginal rings (VRs) in a 1:1:1 ratio,
      25 mg, 100 mg or 200 mg VRs.
    

Detailed description: 
      Participants will be randomized to one of three study vaginal rings (VRs) in a 1:1:1 ratio,
      and those randomized to the 100 mg and 200 mg VRs will not be told their group assignment.
      Participants will insert one VR to be used continuously for 13 weeks (100 mg VR or 200 mg VR)
      or one VR (25 mg VR) to be replaced every 4 weeks for 8 weeks, then worn for an additional 5
      weeks for a total of 13 weeks. Participants will continue follow-up for an additional one to
      three days after final VR removal.
    

Intervention name(s): Dapivirine Vaginal Ring, 25 mg; Dapivirine Vaginal Ring, 100 mg; Dapivirine Vaginal Ring, 200 mg
Intervention type(s): Combination Product; Combination Product; Combination Product
Intervention description(s): Vaginal Ring containing 25 mg dapivirine; Vaginal Ring containing 100 mg dapivirine; Vaginal Ring containing 200 mg dapivirine
Intervention MeSH terms: Dapivirine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Effect of 5, 10 or 25 mg of YF476 Daily for 14 Days on Stomach Acidity in Healthy Volunteers
Condition: Reflux Oesophagitis
MeSH terms: Esophagitis; Esophagitis, Peptic
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of the study was to assess whether the tolerance to the effect of YF476 on
      gastric pH observed with repeated doses in a previous study in healthy volunteers can be
      avoided by using smaller doses of YF476.
    

Detailed description: 
      YF476 is a novel, potent and selective gastrin antagonist that inhibits basal and
      meal-stimulated gastric acid secretion, enhances gastric emptying of a liquid meal and
      increases lower oesophageal sphincter pressure in animals. In a placebo- and
      ranitidine-controlled, crossover study in healthy volunteers, single doses of 5, 25 and 100mg
      of YF476 increased gastric pH; the effect was dose-dependent in magnitude and duration and
      compared favourably with that of ranitidine 150mg. In a placebo- and omeprazole-controlled,
      parallel-group study in healthy volunteers, 25 and 100mg of YF476 twice daily for 7 days, did
      not significantly affect gastric pH unlike omeprazole 20mg daily for 7 days. YF476 and
      omeprazole both increased plasma gastrin concentrations. Single and repeated doses of YF476
      were well tolerated.
    

Intervention name(s): YF476
Intervention type(s): Drug
Intervention description(s): There were 4 treatments: 3 dose levels of YF476 (5mg, 10mg, 25 mg) and placebo.
Each treatment taken by mouth once daily for 14 days (Study Days 1-14). Each subject took 1 of the 4 treatments.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: YF476; gastrin receptor antagonist; gastric pH; gastrin; healthy subjects
HIV-Target Cell Response in Women Initiating Various Contraceptive Methods in High HIV-Incidence Areas: Zim CHIC
Condition: Contraception; HIV; Immune Cells (Mucosal and Systemic); Microbiota
Study type: Observational

Summary: 
      This study is being done to understand if using birth control causes changes in the immune
      cells within the reproductive tract of healthy women. Immune cells are important because they
      help prevent infections from starting and help fight infections that have started. Immune
      cells are also the type of cells that HIV (human immunodeficiency virus) infects so
      understanding more about them will help to better understand how to prevent the spread of
      HIV.

      Immune cells will be studied from the reproductive tract of women who want to start using one
      of the following contraceptives: Depo-Provera (DMPA), NET-EN, MPA/E2 (Cyclofem®), the
      levonorgestrel subdermal implant (Jadelle® ), the etonogestrel subdermal implant (Implanon®
      or Nexplanon® ) and the copper IUD.
    


Intervention name(s): DMPA; NET-EN; MPA/E2; LNG-I; ENG-I; Cu-IUD
Intervention type(s): Drug; Drug; Drug; Device; Device; Device
Intervention description(s): Depot medroxyprogesterone acetate; Norethisterone enantate; Medroxyprogesterone acetate and estradiol cypionate; Levonorgestrel subdermal implant; Etonogestrel subdermal implant; Copper IUD
Other intervention name(s): Depot medroxyprogesterone acetate (DMPA); Norethisterone enantate (NET-EN); Medroxyprogesterone acetate and estradiol cypionate (MPA/E2); Levonorgestrel subdermal implant (LNG-I); Etonogestrel subdermal implant (ENG-I); Copper IUD (Cu-IUD)
Intervention MeSH terms: Medroxyprogesterone Acetate; Estradiol 17 beta-cypionate; Levonorgestrel; Medroxyprogesterone; Etonogestrel; Norethindrone; Estradiol
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy women, age 18-34 years, who are HIV negative and non-pregnant.
      
Biospecimen description: 
      whole blood, plasma archive, vaginal swabs, serum, cervicovaginal lavage fluid
    
Keywords: immune cells; contraception; intrauterine device; IUD; copper; microbiota; DMPA; etonogestrel; subdermal implant; NET-EN; Jadelle; Implanon; Cyclofem
Evaluation of the Water Drinking Test Response in Supine and Sitting Position Using the Continuous Measurement Device Sensimed Triggerfish Intraocular Pressure in Healthy Subjects
Condition: Intraocular Pressure
Study type: Interventional

Summary: 
      Monocentric, prospective study, comparison of the water drinking test response in the supine
      and in the sitting position using the intraocular pressure monitoring device Sensimed
      Triggerfish in healthy subjects.
    


Intervention name(s): Intraocular pressure measurement with the Sensimed triggerfish Device
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Water Drinking Test; Intraocular Pressure; Sensimed Triggerfish
Risk Factors and Machine Learning Model for Proton Pump Inhibitor Related Acute Kidney Injury
Condition: Proton Pump Inhibitor; Acute Kidney Injury
MeSH terms: Acute Kidney Injury; Wounds and Injuries
Study type: Observational

Summary: 
      Recent evidence concerns acute kidney injury (AKI) following proton pump inhibitor (PPI)
      application. Few actual studies have compared the incidence, risk factors, and predictive
      models of AKI associated with PPI. The present study was a single-center retrospective study.
      The researchers retrospectively analyzed data from patients who received PPI medications
      between January 2018 and December 2020. PPI drugs included omeprazole, esomeprazole,
      rabeprazole, and pantoprazole. The primary outcome of the study was AKI, as defined by kidney
      disease: improving global outcomes (KDIGO). Secondary outcomes included length of hospital
      stay, hospital costs, and continuous renal replacement therapy. Independent risk factors
      associated with AKI were identified by univariate analysis and multifactorial logistic
      regression analysis (P < 0.05). Logistic regression models were constructed based on the
      variables obtained from the analysis. Internal validation of the model was performed by the
      ten-fold cross-validation method. Model discriminatory power was assessed by the area under
      the curve (AUC) of the receiver operating characteristic curve (ROC). The study aims to
      develop a PPI-related AKI prediction model based on an electronic medical record system that
      can be used to predict AKI in hospitalized patients and contribute to the early prevention,
      diagnosis and treatment of AKI, ultimately reducing morbidity and improving prognosis.
    


Intervention name(s): Proton pump inhibitor
Intervention type(s): Drug
Intervention description(s): Inpatients using proton pump inhibitor
Intervention MeSH terms: Proton Pump Inhibitors
Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The patients were included if received treatment with proton pump inhibitor and discharged
        from the hospital between January 1, 2018 and December 31, 2020
      
Keywords: Proton pump inhibitor; Acute kidney injury; Pharmacoepidemiology; Miss diagnosis; Risk factors; Logic regression
Effect of Metformin on Patients With Polycystic Ovary Syndrome
Condition: PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Interventional

Summary: 
      The purpose of the study is to understand the effect of Metformin on patients with PCOS.
    

Detailed description: 
      This study aims to evaluate the effects of Metformin on reproductive endocrine and
      reproductive outcomes in women with PCOS, and to explore its underlying mechanisms to provide
      the intervention strategies for PCOS.
    

Intervention name(s): Metformin intervention for 12 weeks
Intervention type(s): Drug
Intervention description(s): PCOS patients were treated with metformin orally for 12 weeks, and various indicators related to fertility were observed.
Other intervention name(s): PCOS patients were treated with metformin for 12 weeks
Intervention MeSH terms: Metformin
Intervention model: Single Group Assignment
Intervention model description: Metformin intervention for 12 weeks
Masking: None (Open Label)
Primary purpose: Basic Science
Investigating the Effectiveness of Intradialytic Massage on Cramping in Dialysis Patients
Condition: End Stage Renal Disease
MeSH terms: Kidney Failure, Chronic
Study type: Interventional

Summary: 
      Primary Aim. The primary aim is to determine the effectiveness of intradialytic massage on
      the frequency and severity of cramping among hemodialysis patients prone to lower extremity
      cramping during treatment.

      Hypothesis: Compared to control patients, intervention patients will be significantly less
      likely to have intradialytic cramping that requires staff intervention or treatment
      termination.

      This is a study involving 32 (16 intervention, 16 control) hemodialysis patients with
      frequent lower extremity cramps during treatment. Frequent cramping during dialysis
      treatments is defined as 1 or more episodes of lower extremity cramps during or after
      dialysis over the previous 2 weeks. Cramping frequency will be determined by chart notes.
      Muscle cramping is defined as contraction of the large muscle group of the lower extremities
      sufficiently painful to require intervention by the dialysis staff for relief.

      The intervention group will receive a 20 minute massage of the lower extremities by a trained
      and licensed massage therapist during each treatment (3x per week) for 2 weeks. The control
      group will receive usual care by dialysis center staff.
    


Intervention name(s): massage
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Human Factor Validation of Pediatric Mobility Device
Condition: Disability Physical
Study type: Interventional

Summary: 
      The purpose of this study is to validate the user interface of a pediatric power mobility
      device by establishing that the product is safe and effective use for the intended users.
    

Detailed description: 
      The purpose of this study is to validate the user interface of a pediatric power mobility
      device by establishing that the product is safe and effective use for the intended users. The
      human factors validation study will be conducted in children with mobility impairments as
      categorised by Hays (1987) in the age range of 6 months to 36 months under realistic use
      conditions.The study is an open label, un-blinded, non-randomized study which consists of one
      visit.
    

Intervention name(s): Device, patient mobility, powered
Intervention type(s): Device
Intervention description(s): Pediatric mobility device
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Pediatric
A Study is to Assess Efficacy and Safety of Tacrolimus in Active Rheumatoid Arthritis Patients Who Showed Unsuccessful Response to Existing Disease Modifying Antirheumatic Drugs (DMARDs)
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is to assess efficacy and safety of tacrolimus in active rheumatoid arthritis
      patients who showed unsuccessful response to existing DMARDs.
    


Intervention name(s): Tacrolimus
Intervention type(s): Drug
Intervention description(s): oral
Other intervention name(s): Prograf
Intervention MeSH terms: Tacrolimus
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: calcineurin inhibitor; Prograf; Rheumatoid arthritis (RA); Tacrolimus