bioihbjkbjnl/mcl2 huggingface dataset:
Clinical Trial to Evaluate the Efficacy of Smoking Cessation
Condition: Smoking Cessation
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to assess the efficacy of smoking cessation by using varenicline
      as monotherapy (VRN + placebo patches) or combined therapy (VRN + nicotine patches).
    

Detailed description: 
      Seven first-line pharmacotherapies are currently available and recommended by clinical
      practice guidelines for treating tobacco dependence, all of them have been proven to be
      effective for increasing tobacco abstinence rates when used as monotherapy. However, not all
      smokers are able to quit with monotherapy. Some smokers may benefit from combination therapy
      that includes the simultaneous use of different nicotine replacement therapies (NRTs) or
      medications with different mechanisms of action (e.g. NRT and bupropion). Combination therapy
      with different drugs may provide a therapeutic advantage by increasing serum nicotine
      concentrations, and may capitalize on synergy obtained from two different mechanisms of
      action. This is why controversy exists regarding this approach as the cost effectiveness of
      this approach has not been clearly demonstrated neither if the genetic profile determine
      different treatment responses.

      Data from a varenicline pharmacokinetic study have documented that among smokers not
      instructed to quit and who continued smoking during treatment , varenicline was associated
      with a 60-80 % of reduction of number of cigarettes and, on the other hand, with a diminution
      of plasmatic nicotine and cotinine concentrations. (See some studies and trials in the
      Background Information).

      This , led to hypotheses that : a) varenicline not saturate completely all acetylcholinergic
      receptors with a incomplete response and ; b) varenicline replace incompletely the
      dopaminergic effect of smoking, with continuous craving. The investigators considered that
      some smokers may need NRT in addition to varenicline to reduce withdrawal and cravings to
      smoke.

      Finally, available data suggests that combination therapy may increase abstinence rates
      compared with monotherapy [OR: 2.4 (2.1- 2.7)] without a significant increase of adverse
      events. So the periodicity, regimen/dose, and periods of combined treatment may be considered
      as safe as the monotherapy even in an off-label indication.
    

Intervention name(s): Varenicline; Nicotine patches; Placebo (nicotine patches)
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): champix; Campix; Nicotinell
Intervention MeSH terms: Nicotine; Varenicline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Keywords: smoking cessation; abstinence; clinical trial; varenicline; nicotine
Effectiveness of 'Supportive Parenting App' on Parental and Newborn Outcomes
Condition: Postnatal Depression; Self Efficacy; Parent-Child Relations; Development, Child; Anxiety; Parenting Satisfaction
MeSH terms: Depression, Postpartum
Study type: Interventional

Summary: 
      The Supportive Parenting App is a theory-based perinatal educational intervention for couples
      administered through a mobile application. The intervention comprise of knowledge-based
      content, informational videos and audio, discussion forum, peer volunteer chat group, and a
      frequently asked questions (FAQ) expert advice section.

      The aims of the study are to:

        1. develop theory-based supportive parenting App (SPA) intervention for both first-time and
           experienced parents across perinatal period

        2. examine its effectiveness on parental outcomes: including maternal depression at 12
           months postpartum (primary outcome), paternal depression, parental anxiety, parenting
           self-efficacy, help - seeking behavior (social support), parental bonding and parenting
           satisfaction (secondary outcomes); and new-born outcomes: physical, social and emotional
           developments (secondary outcomes)

        3. evaluate SPA's cost-effectiveness as compared to standard perinatal care across major
           restructured hospitals, and

        4. examine the perceptions of parents in receiving this intervention.

      When compared with those in the control group receiving standard care:

        1. parents receiving SPA intervention will have better- emotional well-being (reduced
           depression and anxiety);parenting self-efficacy; social support; bonding and
           satisfaction.

        2. new-borns of parents receiving SPA will have better physical, social and emotional
           development

        3. It will be more cost-effective to provide SPA than the standard care
    


Intervention name(s): Supportive Parenting Application
Intervention type(s): Other
Intervention description(s): The Supportive Parenting Application is a theory-based perinatal educational intervention for couples administered through a mobile application. The mobile app consist of knowledge-based content, informational videos and audio, discussion forum, chat groups with peer volunteers, and an experts advice section
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Research Study Looking at How Well a Combination of the Medicines Semaglutide and NNC0480-0389 Works in People With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is looking at semaglutide in combination with a potential new medicine
      (NNC0480-0389) in people with type 2 diabetes.

      The study is being conducted to see how well semaglutide, in combination with different doses
      of NNC0480-0389, work to lower blood sugar levels. Results from this study will be used to
      select the doses of the two medicines for other studies.

      Participants will either get:

      Semaglutide (a medicine doctors can already prescribe for treatment of type 2 diabetes) in
      combination with NNC0480-0389 (a potential new medicine) or placebo (a 'dummy' medicine that
      looks like the medicines but without any medicine).

      NNC0480-0389 alone, or semaglutide alone which treatment participant get is decided by
      chance.

      Participant will need to take 2-3 injections once every week during the study. One injection
      will be with semaglutide or placebo and 1-2 injections will be with NNC0480-0389 or placebo.

      Participant must inject the study medicines themself into the stomach, thigh, or upper arm.

      The study will last for about 41weeks. Participant will have 20 clinic visits. Participant
      will have blood samples taken at all clinic visits. At 3 clinic visits, participant will also
      have an electrocardiogram (ECG). This is a test to check participants heart. Participant will
      have their eyes checked before or at the start of the study and at the end of the study.

      Women can only take part in the study if they are not able to become pregnant
    


Intervention name(s): NNC0480-0389; Semaglutide; Placebo (NNC080-0389); Placebo (semaglutide)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): A weekly dose of NNC0480-0389, dose increased in each cohort. The study will last for about 41weeks.; A weekly dose of semaglutide, same dose in each cohort. The study will last for about 41weeks.; A weekly dose of placebo (NNC0480-0389). The study will last for about 41weeks.; A weekly dose of placebo (semaglutide). The study will last for about 41weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
WebMAP Mobile Self-management of Adolescent Chronic Pain
Condition: Chronic Pain
MeSH terms: Chronic Pain
Study type: Interventional

Summary: 
      Approximately 5-8% of children report severe chronic pain and disability. Although evidence
      supports pain-self management as effective for reducing pain and disability, data show that
      most youth do not have access to this intervention. The investigative team's prior studies
      demonstrate that technology-delivered pain self-management (WebMAP program) can reduce
      barriers to care, is feasible, acceptable, and effective in reducing pain-related disability
      and improving anxiety and depression in youth with chronic pain. In this trial, the
      investigators propose an implementation project to address critical challenges in nationwide
      dissemination of the WebMAP pain self-management program. Using a hybrid
      effectiveness-implementation trial design, 8 clinics from across the U.S. will participate in
      a pragmatic randomized controlled trial with a stepped wedge design to sequentially implement
      WebMAP in the clinics following randomized usual care periods. Data will be collected from
      clinic records, web and app administrative tracking, and provider surveys to gather
      information on adoption and implementation following the Reach, Effectiveness, Adoption,
      Implementation, Maintenance (RE-AIM) public health impact framework. Individual patient-level
      pain outcomes will be collected from 140 patients to evaluate intervention effectiveness. The
      expected outcome of the project is to yield a strategic approach for a nationwide
      technology-delivered pain self-management intervention for youth with chronic pain that can
      be readily sustained in clinical settings.
    


Intervention name(s): Cognitive-behavioral intervention for chronic pain
Intervention type(s): Behavioral
Intervention description(s): WebMAP is a technology-based cognitive-behavioral intervention program that teaches relaxation skills, pain coping strategies and parent behavioral and communication techniques to youth with chronic pain and their parents.
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: This study will employ a stepped wedge cluster randomized design in which clinic sites are randomized sequentially to initiate the intervention. Prior to initiating patient recruitment, each of the 8 clinics will be randomized to one of two waves in the stepped wedge design. During the non-exposure periods, patients will receive usual care from the clinic.
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Adolescent; Cognitive Behavioral Therapy; Chronic Pain; smartphone application; internet-delivered
Comparison of Morphine With Nalbuphine in a Multimodal Approach for Pain Relief in Patients Undergoing Gynecological Procedures: Randomized Controlled Double Blind Clinical Trial
Condition: Pain, Acute
MeSH terms: Acute Pain
Study type: Interventional

Summary: 
      This study was conducted in the Aga Khan University Hospital, Karachi. Pakistan is developing
      country and overall shortage of Morphine in developing country.

      Rationalizing, in multimodal analgesia, Nalbuphine is equivalent to morphine in open
      Abdominal hysterectomy
    

Detailed description: 
      A large number of patients undergoing major surgical procedures need gold standard analgesic
      like morphine for adequate pain control. Shortage of Morphine results in inadequate pain
      relief leading to delayed recovery, prolonged hospitalization and persistent post-surgical
      pain syndrome.

      For better surgical outcome, there is a strong need to find an alternative to morphine in a
      multi modal analgesia that help optimize pain relief with less opioids in patients undergoing
      gynecological procedures
    

Intervention name(s): Morphine,
Intervention type(s): Procedure
Intervention description(s): Nalbuphine along multimodal analgesia(Paracetamol and Ketamine)
Other intervention name(s): Nalbuphine
Intervention MeSH terms: Morphine; Nalbuphine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two groups
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Children Peritonitis Ecology at CHU de Rennes - (IIAPEDIA)
Condition: Peritonitis
MeSH terms: Peritonitis
Study type: Observational

Summary: 
      The main objectif is assess the germs (species + antibiograms) implicated in children
      intra-abdominal infections (community acquired or nosocomial ) at CHU de Rennes.
    


Intervention name(s): microbiological analysis
Intervention type(s): Biological
Intervention description(s): microbiological analysis of the peritoneal fluid
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children with Intra-abdominal infection and indication for surgery or radiologically guided
        drainage
Exploratory Study to Evaluate the Effects of the Probiotics L. Rhamnosus GR-1 and L. Reuteri RC-14
Condition: Vaginosis, Bacterial
MeSH terms: Vaginosis, Bacterial
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this study was to determine whether L. rhamnosus GR-1 and L. reuteri RC-14
      delivered via capsules to the vagina of post-menopausal women over a three day course of
      treatment can restore and maintain a lactobacilli-dominated microbiota. Exploratory analysis
      of microbial ecology, human microarrays and multiplex immunological assessments are included
      to characterize potential effects.
    


Intervention name(s): Lactobacillus capsules; Placebo gelatin pill
Intervention type(s): Other; Drug
Intervention description(s): L. rhamnosus GR-1 and L. reuteri RC-14 capsules manufactured by Chr. Hansen; Placebo Comparator capsules, identical in appearance to the active product; 98% Gelatin with no L. rhamnosus GR-1 and L. reuteri RC- 14.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Predictors of ICU Admission of oPRES
Condition: Posterior Reversible Encephalopathy Syndrome; Intensive Care Units
MeSH terms: Brain Diseases; Posterior Leukoencephalopathy Syndrome; Syndrome
Study type: Observational

Summary: 
      The purpose of this study is to explore the predictors of ICU admission of obstetric
      posterior reversible encephalopathy syndrome.
    

Detailed description: 
      The investigators retrospectively collected data (General information, clinical data,
      biochemical indicators, imaging features, and pregnancy outcome) from pregnant woman
      diagnosed with PRES to explore the predictors of ICU admission during 2012 to 2021.Then, the
      investigators grouped all the patients into ICU group and Non-ICU group according to ICU
      admission or not.
    

Intervention name(s): Whether the patient needs to be admitted to the ICU
Intervention type(s): Other
Intervention description(s): According to ICU admission or not, patients were grouped into ICU group and NOT-ICU group.
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Pregnant Women diagnosed with PRES
Irinotecan Hydrochloride Liposome Injection (LY01610) For Advanced Solid Tumors
Condition: Advanced Solid Tumor
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I, open-label, non-randomized, dose-escalation study to evaluate the safety
      and tolerability, the maximum tolerated dose (MTD) and the dose limited toxicity(DLT) of
      LY01610 monotherapy and combine with 5-Fu in patients with advanced solid tumors.
      Additionally, the pharmacokinetics and preliminary efficacy of LY01610 monotherapy and
      combine with 5-Fu will be investigated in this study.
    

Detailed description: 
      This study will be conducted in two stages: In the first stage, ascending doses of LY01610
      will be administered as monotherapy in participants with solid tumors. The starting dose was
      30 mg/m2 and the subsequent dose was increased according to the protocol of 60 mg/m2, 90
      mg/m2, 120 mg/m2, 150 mg/m2, 180mg/m2. Each subject received only one dose of the drug, and
      the next dose group study could only be performed if the previous dose group was completed 21
      days of observation after the first dose and safe tolerance was confirmed. According to the
      subjects' tolerance, appropriate doses will be selected and the safety, PK characteristics
      and initial efficacy of LY01610 were further evaluated in additional 6 - 8 patients. The
      interval between the first dose and the second dose was 3 weeks, followed by 2 weeks.Another
      8 subjects were enrolled and given CAMPTO® (180 mg/m2) once every 2 weeks to perform the
      pharmacokinetic profiles.

      The second stage is a dose escalation study of LY01610 combined with 5-Fu. Based on the
      results of the first stage, three doses of low, medium and high doses were selected in
      combination with a fixed dose of 5-Fu to determine the DLT and MTD. Similarly, according to
      the subjects' tolerance, appropriate dose will be selected and the safety, PK characteristics
      and initial efficacy of LY01610 combined with a fixed dose of 5-Fu were further evaluated in
      6 - 8 patients. The drug was administered every 2 weeks.
    

Intervention name(s): LY01610 ( Irinotecan hydrochloride liposome injection ); LY01610 ( Irinotecan hydrochloride liposome injection ) with 5-Fu（Fluorouracil Injection）; Irinotecan Hydrochloride Injection（CAMPTO®）
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Part1-Dose Escalation and Part1-Dose Extension : subjects take LY01610;; Part2-Dose Escalation and Part2-Dose Extension : subjects take LY01610 with 5-Fu;; Irinotecan Hydrochloride Injection（CAMPTO®） pharmacokinetics comparative study
Intervention MeSH terms: Fluorouracil; Irinotecan
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: LY01610; 5-Fu; Safety; Tolerability; Pharmacokinetics
Addition of Lidocaine to Levobupivacaine Reduces Intrathecal Block Duration
Condition: Benign Prostate Hyperplasia
MeSH terms: Prostatic Hyperplasia; Hyperplasia
Study type: Interventional
Phase: Phase 4

Summary: 
      The main objective was to test the hypothesis that adding lidocaine to hyperbaric
      levobupivacaine could change the duration of levobupivacaine spinal block.
    

Detailed description: 
      A satisfactory spinal anaesthesia requires both a fast onset and proper duration at the same
      time. Transurethral resection of the prostate (TUR-P) is a surgery of medium duration. The
      addition of lidocaine to hyperbaric bupivacaine shortens the duration of bupivacaine spinal
      block and therefore provides more rapid recovery. This property of lidocaine is not verified
      with other local anesthetics. Levobupivacaine is a S-enantiomer of racemic bupivacaine and is
      a long acting local anesthetic.The aim of this prospective randomized controlled study was to
      investigate this effect of lidocaine, with a local anesthetic other than bupivacaine. It was
      hypothesized that the duration of the intrathecal block could change when performed with
      hyperbaric levobupivacaine mixed with low dose lidocaine and this technique could be
      consistent for the duration of TUR-P surgery. Participants will be followed on the day of
      surgery for primary and secondary outcome measures and 3 days postoperatively for
      complications (TNS).
    

Intervention name(s): Levobupivacaine lidocaine spinal anesthesia; levobupivacaine Spinal anesthesia
Intervention type(s): Drug; Drug
Intervention description(s): Spinal anesthesia; spinal anesthesia
Other intervention name(s): Chirocaine; Lidocaine; Chirocaine
Intervention MeSH terms: Lidocaine; Levobupivacaine; Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hyperbaric Levobupivacaine; İntrathecal; Lidocaine; TUR-P
Atorvastatin Versus Ezetimibe and Fenofibrate as a Lipid-lowering Strategy
Condition: Dyslipidemia; Vascular Disease
MeSH terms: Vascular Diseases; Dyslipidemias
Study type: Observational

Summary: 
      The primary aim of this study is to evaluate the efficacy and non-inferiority of a
      lipid-lowering medication regimen comprised of the medications ezetimibe and fenofibrate
      taken daily, versus atorvastatin daily in lowering levels of low-density lipoprotein (LDL-C)
      cholesterol. Additionally, other aims would include effects on other types of blood
      cholesterol and examining the safety of the ezetimibe and fenofibrate regimen, as compared to
      atorvastatin.
    

Detailed description: 
      It has been demonstrated in several previous primary and secondary studies that lowering
      low-density lipoprotein cholesterol (LDL-C) with the use of medications such as
      3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitors improves mortality and
      morbidity related to cardiovascular events in patients with hypercholesterolemia. Such
      inhibitors, which are known as 'statins', act to block the synthesis of cholesterol in the
      liver. These medications are generally well tolerated by the vast majority of patients, but a
      small number experience side effects, most seriously those of myopathies, rhabdomyolysis and
      elevated liver enzymes - recognition of this fact, that statins are not universally without
      problems, highlights the need for viable alternatives.

      Ezetimibe is a relatively new medication in Canada, approved for use in patients with
      cholesterol problems. It is an intestinal cholesterol binder that is known to be
      well-tolerated, with side effects similar to placebo. Alone, it has a modest effect in the
      lowering of LDL-C. Fenofibrate is a medication that also works through the liver and has long
      been used to adjust blood lipid levels in patients with mixed lipid problems. Alone it also
      has a modest effect in the lowering of LDL-C. Recent study, however, has shown that the
      effect of ezetimibe and fenofibrate together in the lowering of LDL-C is greater than that of
      either drug alone. This combination, if as effective in this regard as atorvastatin, would
      prove a valid alternative to the use of the atorvastatin in the lowering of LDL-C, and a
      benefit for patients who have had problems tolerating statin therapy but still require
      medication for elevated cholesterol.
    

Intervention name(s): Lipitor 20 mg; Combination Ezetrol 10 mg and Lipidil Supra 160 mg
Intervention type(s): Drug; Drug
Intervention description(s): A/A for 6 weeks; a/a for 6 weeks
Intervention MeSH terms: Atorvastatin; Ezetimibe; Fenofibrate
Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Subjects aged 18-85 with elevated LDL-C levels 3.0 mmol/L and greater.
      
Biospecimen description: 
      Apo-lipo B
    
Keywords: Randomized; non-blinded; prospective; open-label; LDL-C; HDL-C