bioihbjkbjnl/mcl2 huggingface dataset:
Influence of Patient Choice of Intrathecal Morphine on Post-cesarean Delivery Pain.
Condition: Pain
Study type: Interventional

Summary: 
      This is a randomized controlled study that will place patients into a "choice" and a "no
      choice" group. The choice group will be able to choose between receiving 100 mcg or 200 mcg
      intrathecal morphine. The no choice group will be randomized to receive either 100 mcg or 200
      mcg of intrathecal morphine. Following casarean delivery, pain scores will be measured at 3,
      6, 12, 24, and 36 hours.
    

Detailed description: 
      This randomised controlled study will include pre-operative screening with a 2 simple
      questionnaires and the patient will be randomised into a "choice" and "no choice" groups.

      The group with the choice will be offered 2 different doses of intrathecal morphine (100, 200
      mcg) which they can decide on after being given a standard script explaining advantages and
      disadvantages of each dose. Following cesarean section patients will be followed up at 3, 6,
      12, 24, 36, 48 hours following spinal injection to assess severity of pain, time to first
      analgesia, total analgesia requirements, treatment of nausea, vomiting and pruritus.
    

Intervention name(s): Drug Dose
Intervention type(s): Other
Intervention description(s): 100 versus 200 mcg IT morphine
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Pharmacokinetics of Imeglimin in Hepatic Impaired Subjects
Condition: Hepatic Impairment
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, single-centre, open-label, parallel-group study in subjects with moderate
      hepatic impairment and subjects with normal hepatic function. Child-Pugh (CP) scoring will be
      used to determine hepatic impairment.
    


Intervention name(s): Imeglimin
Intervention type(s): Drug
Intervention description(s): Single administration dose of imeglimin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pharmacokinetics
Experience of an Emergency Intensive Care Unit During COVID-19 Pandemic
Condition: Covid19
MeSH terms: COVID-19; Emergencies
Study type: Observational

Summary: 
      COVID-19, which emerged in China in December 2019, has become a pandemic with its spread to
      many countries of the world. Emergency departments also carried out an important part of the
      fight against pandemics in our country/Turkey. The emergency department including an
      intensive care unit is very few in this country/Turkey and the only hospital, which has an
      Emergency Intensive Care Unit (EICU) in Istanbul, is the study center. Therefore, this
      retrospective study aimed to provide useful information about how an effective EICU should
      be, especially how to use them during pandemic periods.
    

Detailed description: 
      COVID-19, which emerged in China in December 2019, has become a pandemic with its spread to
      many countries of the world. Emergency departments also carried out an important part of the
      fight against pandemics in our country/Turkey. The emergency department including an
      intensive care unit is very few in this country/Turkey and the only hospital, which has an
      Emergency Intensive Care Unit (EICU) in Istanbul, is the study center. Throughout the
      pandemic, many patients, including COVID-19 patients, were successfully followed up and
      discharged from EICU. With this study, the investigators expect to show the role of EICU
      during the pandemic. In addition, it will be seen that whether the patients, who are waiting
      for hospitalization or waiting for referral, are admitted to EICU faster and their treatments
      will be started promptly. Therefore, this retrospective study aimed to provide useful
      information about how an effective EICU should be, especially how to use them during pandemic
      periods.
    

Intervention name(s): COVID-19 diagnostic PCR
Intervention type(s): Diagnostic Test
Intervention description(s): Nasopharyngeal swab samples will be analyzed by PCR for COVID-19 DNA existence.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        All patients who followed up in emergency department ICU's of study centers with the
        diagnosis of COVID-19
Japanese Phase 1 Multiple Ascending Dose (MAD) Study
Condition: Depression
MeSH terms: Depression
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this clinical study is to assess the safety and tolerability of multiple oral
      doses of BMS-820836 in healthy Japanese subjects and Japanese patients with depression.
    


Intervention name(s): BMS-820836; BMS-820836; BMS-820836; Placebo matching BMS-820836; BMS-820836
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Tablets, Oral, 0.5 mg, Once daily, 14 days; Tablets, Oral, 1 mg, Once daily, 14 days; Tablets, Oral, 2 mg, Once daily, 14 days; Tablets, Oral, 0 mg, Once daily, 14 days; Tablets, Oral, (initiated at 1 mg and dose escalated to the target dose of 2 mg), Once daily, 14 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Comparison of the Combination of Fenofibrate and Simvastatin Versus Atorvastatin
Condition: Hyperlipidemia
MeSH terms: Hyperlipidemias; Hyperlipoproteinemias
Study type: Interventional
Phase: Phase 3

Summary: 
      Mixed or combined hyperlipidemia is a common metabolic disorder characterized by both
      hypercholesterolemia and hypertriglyceridemia. Statins and fibrates have complementary
      mechanisms and can be coadministered to patients with mixed hyperlipidemia. The overall
      objective of the study is to compare the efficacy and safety of combining fenofibrate and
      simvastatin versus atorvastatin monotherapy in patients with mixed hyperlipidemia at risk of
      cardiovascular diseases.
    


Intervention name(s): fenofibrate / simvastatin; Atorvastatin
Intervention type(s): Drug; Drug
Intervention description(s): Combination of fenofibrate and simvastatin 20 mg and 40 mg; Atorvastatin 10 mg and 20mg
Intervention MeSH terms: Atorvastatin; Simvastatin; Fenofibrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hyperlipidemia Combined; efficacy combination fenofibrate simvastatin versus atorvastatin
Effects of an Intervention Program Based on Pain Education in Patients With Chronic Pelvic Pain
Condition: Pelvic Pain
MeSH terms: Pelvic Pain
Study type: Interventional

Summary: 
      The purpose of this study is to obtain imaging biomarkers based on changes in activity
      patterns and changes in brain connectivity obtained with the analysis of functional magnetic
      resonance imaging (fMRI) and tractography that are related to chronic pelvic pain
    


Intervention name(s): Pain education
Intervention type(s): Other
Intervention description(s): The patient education provides a basic set of information that includes the explanation of possible pathophysiological mechanisms involved in the development of chronic pain. The main objective is to reduce pain threatening and alarmist interpretation. The patient must understand that the pain is not necessarily a sign of injury, but the consequence of a maladaptive central sensitization. One element of this therapeutic strategy is to help the patient to perform physical activities that involve a gradual exposition to stimuli associated with their pain and promote physical recovery exposure. Pain education also aims to reduce fear-avoidance behavior and the patient's disability.
Other intervention name(s): pain neuroscience education
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Outpatient Treatment of Constipation in Children
Condition: Constipation
MeSH terms: Constipation
Study type: Interventional

Summary: 
      Constipation is a condition often seen in children. Constipation is often associated with
      impaired quality of life of the child and of great concern among parents. Despite the fact
      that both diagnosis and treatment is a simple task, it is often seen that the treatment
      fails, and many children are referred to a pediatric ward for specialized treatment.

      There is currently little research on the subject and treatment is therefore based on expert
      knowledge rather than scientific research.

      The study objective is to identify the most effective and least stressful treatment of
      children with constipation for both families and the health care system.

      The following will be tested:

      Does treatment of constipation in children require specialized knowledge and extensive
      resources or can the treatment be simplified?

      The results from this study are expected to form the basis for a evidence based treatment of
      children with constipation.
    


Intervention name(s): Telephone counseling; Web access
Intervention type(s): Other; Other
Intervention description(s): 2 planned telephone counseling sessions are conducted.; Access to a web site with information about childhood constipation similar to the information given at the first visit to the clinic.
Other intervention name(s): Telephone; Web
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: constipation; children; outpatient
Curcumin and Intravitreal Dexamethasone in Diabetic Macular Edema
Condition: Diabetic Macular Edema
MeSH terms: Macular Edema; Edema
Study type: Interventional

Summary: 
      The aim of the study is to explore the effect of a curcumin formulation in combination to
      intravitreal dexamethasone therapy in patients with diabetic macular edema on morphological
      retinal characteristics and retreatment times.
    

Detailed description: 
      Patients with diagnosis of clinically significant diabetic macular edema, confirmed by
      fluorangiography and OCT, undergoing to intravitreal dexamethazone injection will be enrolled
      in the study.

      Enrollment will take place according to the inclusion/exclusion criteria set by the protocol.

      The enrolled patients will be randomized for the addition or not of the curcumin formulation
      (2 tablets/die for 6 months) to intravitreal therapy.
    

Intervention name(s): DIABEC plus intravitreal dexamethazone
Intervention type(s): Combination Product
Intervention description(s): Patients with diabetic macular edema undergoing to intravitreal dexamethazone will be randomized to curcumin formulation (DIABEC)
Other intervention name(s): Intravitreal dexamethazone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Therapy for diabetic macular edema; Curcumin formulation (DIABEC)
Sorafenib in Liver Function Impaired Advanced Hepatocellular Carcinoma
Condition: Liver Cancer
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Due to the HBV and HCV infection, about 55% hepatocellular carcinoma patients happened in
      China. Among them, only 10% patients can be diagnosed in early stage. Sorafenib increased PFS
      and OS in advanced hepatocellular carcinoma patients with liver function of Child-Pugh class
      A patients, but the result for Child-Pugh class B patients is unclear.
    


Intervention name(s): Sorafenib; Best Supportive Care
Intervention type(s): Drug; Other
Other intervention name(s): Nexavar
Intervention MeSH terms: Sorafenib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Sorafenib; Hepatocellular carcinoma; Best supportive care; Survival
Effect of Pitavastatin on Coronary Flow Reserve in Hypertensive Patients
Condition: Hypertension; Cardiovascular Risk
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      Although statins reduce cardiac events in hypertensive patients with cardiovascular risk
      factors, the effect of statins on coronary flow reserve (CFR) has not been examined in such
      patients. The investigators hypothesize that pitavastatin added to standard antihypertensive
      therapy will be superior to placebo in improving CFR in hypertensive patients with
      cardiovascular risk, and try to examine this hypothesis in a double-blind, randomized
      comparison study using Doppler echocardiography.
    

Detailed description: 
      Statin treatment improves coronary flow reserve (CFR) and decreases cardiac morbidity and
      mortality in patients with coronary artery disease (CAD) and hypercholesterolemia.
      Endothelial dysfunction and impairment in coronary microcirculation is also observed in
      hypertensive patients with cardiovascular risk factors. However, the measurement of CFR has
      rarely been performed in hypertensive patients without CAD, because CFR could be invasively
      measured using a Doppler guide wire in a cardiac catheterization laboratory. Recent advances
      in echocardiographic imaging techniques have made it possible to measure coronary flow
      velocity and CFR, which highly correlates with the CFR measured by invasive means.

      Lipid lowering with a statin provided beneficial effects in patients with average levels of
      serum total cholesterol in the Anglo-Scandinavian Cardiac Outcomes Trial-Lipid Lowering Arm
      (ASCOT-LLA) study conducted in hypertensive patients at cardiovascular risk. Improvements in
      endothelial dysfunction and CFR may be related to the beneficial effects of statins in
      hypertensive patients without hypercholesterolemia, but the effect of statins on CFR has not
      been examined in such patients. Accordingly, the investigators try to examine the hypothesis
      that pitavastatin added to standard antihypertensive therapy in hypertensive patients with
      cardiovascular risk will be superior to placebo in improving CFR in a double-blind,
      randomized comparison study using Doppler echocardiography.
    

Intervention name(s): Pitavastatin; Control
Intervention type(s): Drug; Other
Intervention description(s): statin; Life style modification alone
Other intervention name(s): Livalo
Intervention MeSH terms: Pitavastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hypertension; Statin
A Trial to Investigate the Pharmacokinetics (PK) of Single Doses of 200 µg, 400 µg and 2 x 400 µg of Intranasal Fentanyl Spray (INFS) in Healthy Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The overall clinical trial objective is to gain information about the Pharmacokinetics (PK)
      of a 400 µg dose strength of INFS using a Population PK (PopPK). In total, 20 healthy male
      and female subjects are planned to be randomized in the trial. Subjects will be randomized to
      one of two treatment sequences and treated with 3 different dosages (either 200 µg/dose INFS,
      400 µg/dose or 400 µg two doses administered 10 minutes apart) over two days. Subjects will
      be hospitalized over a period of total 5 days, where safety assessments and pharmacokinetic
      samplings will be conducted.
    


Intervention name(s): INFS (Intranasal Fentanyl Spray)
Intervention type(s): Drug
Intervention description(s): Intranasal Fentanyl Spray
Other intervention name(s): (Instanyl®)
Intervention MeSH terms: Fentanyl
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Intranasal fentanyl spray; Population PK
A Study in China Evaluating the Safety and Efficacy of Adding Sitagliptin to Stable Therapy With Insulin With or Without Metformin in Participants With Type 2 Diabetes Mellitus (T2DM) (MK-0431-254)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      A study to compare safety and efficacy of sitagliptin and placebo therapy when added to
      stable insulin alone or in combination with metformin in participants with type 2 diabetes
      mellitus (T2DM). The primary hypothesis of this study is that after 24 weeks, the addition of
      sitagliptin compared with placebo provides greater reduction in hemoglobin A1C (HbA1C) in
      T2DM participants on insulin alone or in combination with metformin.
    


Intervention name(s): Sitagliptin; Placebo; Insulin; Metformin
Intervention type(s): Drug; Drug; Biological; Drug
Intervention description(s): Sitagliptin 100 mg once daily for 24 weeks; Matching placebo once daily for 24 weeks; Participants can be on on pre-mixed (mixture of rapid- and long-acting insulin) or intermediate- or long-acting insulin at a dose of at least 12 U/day.; At randomization, participants will be stratified according to their use of metformin (on or not on). All participants receiving metformin will be required to be on a daily dose of metformin at least 1500 mg per day.
Other intervention name(s): Januvia®; MK-0431
Intervention MeSH terms: Metformin; Sitagliptin Phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Risk Reduction for Drug Use and Sexual Revictimization
Condition: Risk Reduction Through Family Therapy; Usual Care
Study type: Interventional

Summary: 
      The investigator proposes to evaluate Risk Reduction through Family Therapy (RRFT), which
      integrates: 1) an ecologically-based intervention for treatment of substance abuse behaviors
      in high risk adolescents, 2) exposure-based cognitive-behavioral therapy for sexually
      assaulted youth, and 3) psychoeducation strategies for prevention of risky sexual behaviors
      and revictimization. The principal purpose of this research proposal is to evaluate the
      efficacy of RRFT in reducing the risk of drug abuse and other risky behaviors, PTSD, and
      revictimization among adolescents who have been sexually assaulted. The Research Plan will be
      conducted based on Stage 1a and Stage 1b from NIDA's Behavioral Therapies Development Program
      as described in Rounsaville, Carroll, & Onken (2001). The final phase of the research will
      involve conducting a pilot randomized controlled trial of RRFT in a sample of adolescents,
      comparing primary outcome measures of youth receiving RRFT to youth receiving usual care in
      the community. Participants will be adolescents (12-17 years) who have experienced a sexual
      assault. Assessment of substance use and other risk behaviors, trauma-related
      psychopathology, and incidents of revictimization will be collected at pre- and post-
      treatment, as well as 6-week and 3-month follow-ups. Hierarchical Linear Modeling will be the
      primary method used to test study hypotheses. Development and evaluation of the proposed
      intervention will have significant implications for addressing public health problems in
      adolescent substance abuse and related high risk behaviors.
    

Detailed description: 
      See above summary
    

Intervention name(s): Risk Reduction through Family Therapy
Intervention type(s): Behavioral
Intervention description(s): Component based intervention based on existing empirically supported treatments
Other intervention name(s): RRFT
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: substance use; PTSD; risky behaviors; revictimization
A Trial to Compare the Duration of Analgesic Efficacy and Safety of Naproxen Sodium Tablets and Ibuprofen Tablets in Postsurgical Dental Pain
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      To compare the duration of analgesic efficacy as determined by the time to rescue medication
      of a single oral dose of naproxen sodium 440 mg (2 x 220 mg tablets) relative to ibuprofen
      400 mg (2 x 200 mg tablets) and placebo over 24 hours in subjects experiencing moderate to
      severe post-impaction surgery dental pain.

      To compare the overall analgesic effect (SPID 0-24) of a single dose of naproxen sodium 440
      mg (2 x 220 mg tablets) relative to ibuprofen 400 mg (2 x 200 mg tablets) and placebo.

      To compare the overall relief from pain (TOTPAR 0-24) of a single dose of naproxen sodium 440
      mg (2 x 220 mg tablets) relative to ibuprofen 400 mg (2 x 200 mg tablets) and placebo.
    


Intervention name(s): Naproxen Sodium (Aleve, BAY117031); Ibuprofen (Advil); Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 220 mg x 2 tablets, oral, single dose; 200 mg x 2 tablets, oral, single dose; Matching placebo, 2 tablets, oral, single dose
Intervention MeSH terms: Ibuprofen; Naproxen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Postsurgical pain