bioihbjkbjnl/mcl2 huggingface dataset:
Use of Misoprostol for Intrauterine Device (IUD) Insertion in Nulliparous Women
Condition: Contraception
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate if the use of misoprostol can make it easier for a
      provider, and less painful for a woman, to place an IUD if she has never had a child before.
    

Detailed description: 
      IUD's are a tremendously effective long acting, reversible method of contraception, and they
      require little participation from the woman after insertion. Despite these benefits, few
      women in the US use an IUD. Education is important so that both providers and women
      understand that IUD's are safe and effective in women even if they have never had a child.
      Insertion of an IUD in nulliparous patients can be more difficult and uncomfortable. The
      purpose of this study is to see if use of misoprostol prior to IUD placement in nulliparous
      women can make it easier and less painful. The goal is that more information on the
      feasibility and ease of IUD insertion will make it more accessible to more women. The
      findings from this trial will be used in a prospective meta analysis on this topic.
    

Intervention name(s): Misoprostol; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 400 micrograms of misoprostol or placebo inserted buccally or vaginally prior to IUD insertion; 400 micrograms of misoprostol or placebo inserted buccally or vaginally prior to IUD insertion
Intervention MeSH terms: Misoprostol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Health Services Research
Keywords: IUD insertion; nulliparous women; contraception
Safety, Tolerability, and Efficacy of GS-4997 Alone or in Combination With Simtuzumab (SIM) in Adults With Nonalcoholic Steatohepatitis (NASH) and Fibrosis Stages F2-F3
Condition: Non-Alcoholic Steatohepatitis (NASH)
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease; Fibrosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to evaluate the safety and tolerability of GS-4997
      (selonsertib [SEL]) alone or in combination with simtuzumab (SIM) in adults with nonalcoholic
      steatohepatitis (NASH) and fibrosis stages F2-F3. Participants will be randomized in a
      2:2:1:1:1 ratio to 1 of 5 study treatment arms.
    


Intervention name(s): SEL; SIM
Intervention type(s): Drug; Biological
Intervention description(s): SEL tablet administered orally once daily; Simtuzumab (SIM) 125 mg/mL single-dose vials administered subcutaneously once weekly
Other intervention name(s): GS-4997; GS-6624
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: GS-4997; Non-alcoholic fatty liver disease (NAFLD); Fibrosis; Simtuzumab (SIM); Apoptosis signal-regulating kinase 1; ASK1 inhibitor
Dermacyd Silver Frutal (Lactic Acid) - Compatibility.
Condition: Hygiene
Study type: Interventional
Phase: Phase 3

Summary: 
      Primary Objective:

      To demonstrate the absence of irritation potential (primary dermic irritability and cumulated
      dermic irritability) and allergy (sensibilization) of the product Dermacyd Silver Frutal.
    


Intervention name(s): LACTIC ACID(ND)
Intervention type(s): Drug
Intervention description(s): Dermacyd Silver Frutal (Lactic Acid) sample will be applied like a curative for 21 consecutive days.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Subtenon Block Combined With General Anesthesia for Vitreoretinal Surgery
Condition: Subtenon Anesthesia
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the effects of subtenon block (SB) as an adjunct to general anaesthesia on
      postoperative pain, oculocardiac reflex and postoperative nausea and vomiting for
      vitreoretinal surgery.
    


Intervention name(s): 2% lidocaine and 0.5% bupivacaine; Sham subtenon block
Intervention type(s): Drug; Drug
Intervention description(s): Under general anesthesia and the operating microscope, a Lieberman lid speculum was placed and the conjunctiva was cleaned with 4% povidone iodine solution. The surgeon then created a fornix-based incision through conjunctiva and tenon's tissue inferonasally midway between the insertions of the medial and inferior rectus muscles, with blunt Wescott scissors to expose the scleral surface before tunneling posteriorly with curved Stevens scissors to create a small channel to the posterior subtenon space. A blunt-tipped subtenon cannula was then inserted into the posterior subtenon space, 4mL of 2% lidocaine and 0.5% bupivacaine (50:50) mixture versus saline was introduced and the drug solution was injected slowly into the subtenon space. After administration of local anesthetic mixture, the eyelid was gently taped down, and no ocular massage was performed
Intervention MeSH terms: Lidocaine; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Supportive Care
Keywords: Vitreoretinal surgery
Gut Microbiome and ICU Delirium Post Cardiac Surgeries
Condition: Intensive Care Unit Delirium
MeSH terms: Delirium
Study type: Observational

Summary: 
      ICU delirium are assessed by clinical nurses twice every day. Delirious patients are matched
      with patients according to their disease, gender and age range(±3 years). Stool samples for
      gene sequencing are collected. Gut barrier function are studied with several serum biomarkers
      (endotoxin, etc.). Ecological analyses, regression models and mediation equation will be
      performed.
    

Detailed description: 
      ICU delirium are assessed by clinical nurses twice every day using Confusion Assessment
      Method for the ICU (CAM-ICU). Delirious patients are matched with patients according to their
      disease, gender and age range(±3 years). Stool samples for gene sequencing are collected
      within 24 hours after surgeries. Gut barrier function are studied with several serum
      biomarkers (endotoxin, etc.). Ecological analyses, regression models and mediation equation
      will be performed.
    

Intervention name(s): No intervention
Intervention type(s): Other
Intervention description(s): No intervention.
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients after cardiac surgery and admitted to CSICU are recruited.
      
Keywords: delirium
Effect of Rosiglitazone on the Vascular Biology of Human Fat Tissue
Condition: Metabolic Syndrome; Insulin Resistance
MeSH terms: Metabolic Syndrome; Insulin Resistance
Study type: Interventional
Phase: Phase 2

Summary: 
      Insulin resistance is a common condition that can lead to type 2 diabetes. One of the
      commonly prescribed diabetes medications, called rosiglitazone, works by decreasing insulin
      resistance. Rosiglitazone appears to work on fat cells. Animal studies suggest that
      rosiglitazone may work by increasing blood vessel growth in fat cells. The purpose of this
      research is to see if rosiglitazone also increases blood vessel growth in human fat cells.
      The investigators will compare results from before and after being on rosiglitazone for 6
      weeks.
    

Detailed description: 
      Adipocytes play a crucial role in the control of metabolic homeostasis, by sequestering
      excess calories in the form of triglycerides, and secreting cytokines that control systemic
      fuel utilization. Sustained excess calorie consumption results in adipocyte hypertrophy and
      hyperplasia, and like any expanding tissue, requires increased capillary expansion to nourish
      the enlarged adipose tissue mass. Recent reports indicate that decreased capillary density in
      adipose tissue of obese individuals correlates with insulin resistance, suggesting that an
      imbalance of angiogenesis and adipogenesis may underlie this condition. To determine whether
      improvement in insulin sensitivity is related to changes in adipose tissue capillary
      development, we conducted a randomized, double-blind, placebo-controlled trial to determine
      capillary density, angiogenic growth potential, and metabolic parameters in healthy human
      volunteers before and after treatment with rosiglitazone, a potent insulin sensitizer.
    

Intervention name(s): Rosiglitazone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): One 8mg capsule daily for 6 weeks.; One capsule daily for 6 weeks.
Other intervention name(s): Avandia
Intervention MeSH terms: Rosiglitazone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Evaluation of Clinical Parameters on Admission and Medications in Covid-19 Pneumonia (Corona Virus Disease 2019)
Condition: Covid-19
MeSH terms: COVID-19; Pneumonia
Study type: Observational

Summary: 
      Investigators will recruit patients diagnosed with COVID-19 pneumonia between March 11th,
      2020 and April 15th, 2020 in emergency, internal medicine and cardiology outpatient clinics,
      retrospectively and analyze their clinical and demographic features on admission in regard to
      their medications used for chronic diseases regularly.
    

Detailed description: 
      Covid-19 infections demonstrated a pandemic spread after January 2020 and their associations
      with patient characteristics and comorbidities are intensely studied. Investigators also want
      to find out potential relations between major medications taken for chronic diseases and
      clinical parameters of patients with Covid-19 pneumonia.

      For the study, investigators will recruit patients diagnosed with COVID-19 pneumonia between
      March 11th, 2020 (the date at which the first case of Covid-19 in Turkey officially declared)
      and April 15th, 2020 in emergency, internal medicine and cardiology outpatient clinics,
      retrospectively. All of the demographic features, complaints on admission, reports of
      computed tomography (CT) scans of the chest without intravenous contrast issued by the staff
      radiologist, c-reactive protein (CRP) and complete blood count (CBC) values on admission will
      be recorded retrospectively. Their polymerase chain reaction (PCR) test results will be
      derived from the hospital records based on public health covid-19 database notifications and
      list of medications taken regularly for more than 8 weeks before the diagnosis of COVID-19
      pneumonia from the national pharmacy database. Information about other systemic diseases and
      major medical conditions of patients will be procured from the medical histories gained by
      relevant physicians. Patient taking each drug group will be compared to those not taking that
      drugs in terms of clinical and demographical features mentioned above. Statistical analysis
      will be performed by using SPSS software.
    

Intervention name(s): ACE Inhibitors and Calcium Channel Blockers
Intervention type(s): Drug
Intervention description(s): effect of drugs on patients with covid-19 pneumonia
Other intervention name(s): NSAID
Intervention MeSH terms: Calcium Channel Blockers; Calcium; Angiotensin-Converting Enzyme Inhibitors
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        first diagnosis with covid-19 pneumonia
      
Keywords: covid-19 pneumonia; medication; comorbidity
Safety and Effectiveness of PRX-08066 in Patients With Pulmonary Hypertension and Chronic Obstructive Pulmonary Disease
Condition: Pulmonary Hypertension; Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Hypertension, Pulmonary; Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is being conducted to see if PRX-08066 can lower pulmonary artery pressures in
      patients with pulmonary hypertension associated with chronic obstructive pulmonary disease.
    


Intervention name(s): PRX-08066
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Pulmonary Hypertension; PH; Pulmonary Arterial Hypertension; PAH; Chronic Obstructive Pulmonary Disease; COPD; PRX-08066; Predix
Open Label Extension Study of Epratuzumab in Japanese Systemic Lupus Erythematosus (SLE) Subjects
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Study type: Interventional
Phase: Phase 2

Summary: 
      The study is an open-labeled extension study to continue to assess the safety and
      tolerability of Epratuzumab in moderate to severe SLE subjects who have previously
      participated in SL0026 [NCT01449071] phase I/II trial.
    


Intervention name(s): Epratuzumab
Intervention type(s): Biological
Intervention description(s): Epratuzumab 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over eight 12-week treatment cycles (ie, Weeks 0, 1, 2, 3, 12, 13, 14, 15, 24, 25, 26, 27, 36, 37, 38, 39, 48, 49, 50, 51, 60, 61, 62, 63, 72, 73, 74, 75, 84, 85, 86, and 87)
Intervention MeSH terms: Epratuzumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Lupus; Monoclonal antibody; B-cell immunotherapy; Epratuzumab
Non-dispensing Fitting Study Comparing the Clinical Performance Hydrogel Sphere Design Contact Lenses.
Condition: Myopia
MeSH terms: Seizures; Myopia
Study type: Interventional

Summary: 
      The aim of this non-dispensing study is to evaluate the clinical performance of different
      hydrogel contact lens designs.
    

Detailed description: 
      This is a 35-subject, double masked, randomized, contra lateral, non-dispensing fitting trial
      comparing different hydrogel lens materials. For each study, this study will involve 2
      visits: lens dispensing (baseline) and 1 hour post lens settling. Each subject will be
      randomized to wear the test and control lenses, in the right or left eye, in a series of four
      short fitting comparisons as follows:

      Pair 1 (P1): filcon IV I (Base Curve (BC) 8.6) and ocufilcon D

      Pair 2 (P2): filcon IV I (Base Curve (BC) 8.7) and ocufilcon D

      Pair 3 (P3): methafilcon A (Base Curve (BC) 8.6) and ocufilcon D

      Pair 4 (P4): methafilcon A (Base Curve (BC)8.7) and somofilcon A
    

Intervention name(s): filcon IV I (BC 8.6); filcon IV I (BC 8.7); ocufilcon D; methafilcon A (BC 8.6); methafilcon A (BC 8.7); somofilcon A
Intervention type(s): Device; Device; Device; Device; Device; Device
Intervention description(s): control lens; control lens; test lens; control lens; control lens; test lens
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HRS9531 in Healthy Subjects
Condition: Type 2 Diabetes
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is being conducted to evaluate the safety, tolerability, pharmacokinetics, and
      pharmacodynamics of single and multiple subcutaneous injections of HRS9531 in healthy
      subjects.
    


Intervention name(s): HRS9531; placebo; HRS9531; placebo
Intervention type(s): Drug; Other; Drug; Other
Intervention description(s): Administered SC once; Administered SC once; Administered SC for multiple dose; Administered SC for multiple dose
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: HRS9531 compared with placebo
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Triglyceride/High-density Lipoprotein Cholesterol Ratio in Chronic Kidney Disease
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Observational

Summary: 
      The Triglycerides (TG) to High Density Lipoprotein Cholesterol (HDL-C) ratio is a feature of
      insulin resistance and an independent predictor of cardiovascular risk. The investigators
      aimed to evaluate the relationship between TG/HDL-C ratio and the endothelial functions in
      patients with CKD.
    

Detailed description: 
      Cardiovascular disease (CVD) risk is substantially increased in subjects with chronic kidney
      disease (CKD).The reasons for the elevated risk of CVD in patients with CKD are not fully
      elucidated. There is not a good prognostic tool for the prediction of increased
      cardiovascular risk in CKD. A simple, widely available, relatively inexpensive, and generally
      reproducible marker to predict the CVD risk in subjects with CKD is needed.

      The Triglycerides (TG) to High Density Lipoprotein Cholesterol (HDL-C) ratio is a feature of
      insulin resistance and an independent predictor of cardiovascular risk. No study has been
      performed so far, to evaluate the role of TG/HDL ratio to predict the CVD risk in patients
      with CKD.

      This study is designed to evaluate the relationship between TG/HDL-C ratio and the
      endothelial functions in patients with CKD.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        renal unit
      
Keywords: Chronic kidney disease; Endothelial dysfunction; Inflammation; Insulin resistance; Tg/hdl ratio
Randomized Clinical Trial to Assess the Effectiveness of the GlucoWatch Biographer
Condition: Diabetes Mellitus, Insulin-Dependent
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will evaluate the safety and effectiveness of a continuous glucose monitor in
      children with Type 1 diabetes mellitus (T1DM).
    

Detailed description: 
      Intensive control of blood glucose levels has been shown to substantially prevent or delay
      complications of T1DM in adolescents and adults. The major limitation to implementation of
      intensive glycemic control is hypoglycemia. Younger children may be at increased risk for
      hypoglycemia, and the risk/benefit ratio of intensive glycemic control may be less favorable
      in this population. The Diabetes Research in Children Network (DirecNet) was established to
      evaluate the feasibility and effectiveness of intensive glycemic control in children with
      T1DM.

      This study is designed to evaluate glycemic control, hypoglycemia, and quality of life when
      using a GlucoWatch G2TM Biographer (GW2B) versus standard care. Children in the study will
      use the GW2B in their home environment in order to assess if the GW2B can help to safely
      lower blood sugar levels (as measured by the glycosylated hemoglobin test), to learn how
      using the GW2B affects the daily lives of children with diabetes, and to find out if there
      are any drawbacks to using the GlucoWatch.

      As part of the study, participants in the intervention group will also use a second glucose
      monitoring device called the Continuous Glucose Monitoring System (CGMS). The CGMS will be
      inserted at baseline and at Months 3 and 6; it will be worn for three days after each visit.
      The CGMS will be used to measure changes in biochemical hypoglycemia.

      Participants at five participating centers will include a total of 200 children and
      adolescents with type 1 diabetes. Of the 200 children, 100 will be randomized to wear the
      GW2B and 100 will be randomized to usual care without GW2B. Each patient will be provided
      with a personal computer for weekly downloading of data and completion of questionnaires
      regarding hypoglycemia. Phone contacts will be made with the patients after Weeks 1, 2, and
      4, then every 4 weeks to review their diabetes management. At Months 3, 6, 9 and 12, a
      follow-up visit will be performed to measure HbA1c. The CGMS sensor will be inserted to
      assess hypoglycemia at baseline and Months 3 and 6. At the 6-month follow-up visit,
      psychosocial questionnaires will also be administered.
    

Intervention name(s): GlucoWatch® G2™ Biographer (GW2B); Continuous Glucose Monitoring System (CGMS)
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes Mellitus, Insulin-Dependent; Type 1 Diabetes; Diabetes in Children; Continuous Glucose Monitoring Devices
Investigation of Supra Fiber in the Treatment of Adults With Constipation
Condition: Constipation
MeSH terms: Constipation
Study type: Interventional

Summary: 
      Background: Whether Supra-Fiber, a plum-derived fiber supplement is useful in the treatment
      of constipation is not known. Supra Fiber is the first fiber supplement that has a blend of
      whole food fruit as its main ingredient. It contains prunes, pomegranates, blueberries, and
      Acai berries. Unlike psyllium, which is mostly (90%) insoluble fiber, Supra Fiber is a
      balanced (50%) blend of insoluble and soluble fiber. This may provide the beneficial effects
      of fiber, and eliminate potential adverse symptoms of fiber such as bloating, distention,
      hard bulky stools and excess gas. In this study, we expect to not only evaluate the efficacy
      but also the palatability and tolerability of Supra Fiber in the treatment of chronic
      constipation.

      Aims:

        1. To investigate and compare the effects of Supra Fiber (5 grams BID) or psyllium (5 grams
           BID) on the number of complete spontaneous bowel movements per week, and bowel symptoms.

        2. To examine the effects of fiber supplements on taste and quality of life in adults with
           functional chronic constipation in a randomized, double-blind, parallel group controlled
           trial.

      Methods: We propose to enroll 90 subjects with functional constipation in a single blinded,
      randomized, cross-over study comparing 4 weeks of Supra Fiber with 4 weeks of treatment with
      Psyllium

      Data analysis: The primary outcome measure will be the global relief of constipation symptoms
      as rated by the subject at the end of each phase of the study. Additionally, we will assess
      several secondary outcome measures that will include the number of Complete Spontaneous Bowel
      Movements (CSBM) per week, Quality of Life , psychological profile, patient rating of taste
      on a VAS scale, patient rating of bloating, distension, satiety and fullness and patient
      rating of constipation-related symptoms.

      Expected results: We anticipate that treatment with Supra Fiber will improve symptoms of
      constipation compared to the baseline. This improvement will be comparable or superior to
      that achieved with psyllium treatment. Additionally, Supra Fiber will offer a natural, food
      based, convenient and more tasty alternative to over-the-counter laxatives and fiber
      supplements.
    


Intervention name(s): Supra Fiber; Psyllium
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 2 tablespoons of fiber taken with 8oz water taken twice a day for 30 days; 1 tablespoon of fiber taken with 8 oz water twice a day for 30 days
Intervention MeSH terms: Psyllium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment