bioihbjkbjnl/mcl2 huggingface dataset:
Dose-finding Study of Intrathecal Paracetamol Administered Immediately Before Spinal Anaesthesia
Condition: Phase 1: Pain Management; Phase 2: Pain Management
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Two-part study of intrathecal paracetamol administered immediately before spinal anaesthesia
      in patients scheduled for hip replacement surgery
    

Detailed description: 
      This is a prospective, single centre, two-part, three doses study. Part 1 is a Phase I, three
      cohorts, dose-ascending, open-label, safety study. Part 2 is a Phase II, randomised,
      parallel-group, double-blind, placebo-controlled, exploratory efficacy and safety study The
      objective of the study is to investigate the efficacy and safety of a single intrathecal
      injection of paracetamol, administered at 3 doses to 3 active treatment groups, as compared
      to placebo solution, for post-operative analgesia of hip replacement surgery performed under
      spinal anaesthesia. Patients scheduled for hip replacement surgery will be randomised into 4
      treatment groups (15 patients per group) to receive either one of the 3 single doses of
      paracetamol 3% (D1: 60 mg, D2: 90 mg, D3: 120 mg) or placebo solution (P: saline solution) by
      intrathecal (IT) injection. Immediately after paracetamol or placebo IT administration, all
      patients will receive a single IT dose of Hyperbaric Bupivacaine HCl 0.5% (12.5 mg for ≤ 160
      cm-tall patients and 15 mg for > 160 cm-tall patients). The time interval between paracetamol
      IT and bupivacaine IT administrations should not exceed 2 min.

      The study will include a screening phase (Visit 1, Days -21/1), a treatment phase
      (paracetamol IT administration, anaesthesia and surgical procedure: Visit 2, Day 1) and a
      follow-up phase including an observation period (Visit 3, from Day 1 after surgery until
      discharge, a final visit (at discharge) and a follow-up (day 6±1). Pain at rest will be
      assessed at screening and on visit 2 at baseline (0 h), 1, 2, 3, 6, 9, 12, 15, 18, 21, 24,
      27, 30, 33, 36, 39, 42, 45 and 48 h after anaesthetic IT injection and at discharge, using a
      0-100 mm VAS.
    

Intervention name(s): Paracetamol 3%; Placebo injection containing Saline solution 0.9%; Hyperbaric Bupivacaine HCl 0.5%
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Investigate the efficacy and safety of a single intrathecal injection of paracetamol,for post-operative analgesia of hip replacement surgery; Injection containing sterile solution of Saline Solution 0.9 %. Study part 2 will be placebo-controlled. Each patient will be allocated to a treatment arm (one of the three paracetamol doses or placebo) according to a computer-generated randomisation list.; NIMP, spinal anaesthetic before the surgical procedure
Intervention MeSH terms: Acetaminophen; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 4 arms for Phase II only
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
The Single Branch NEXUS™ Clinical Study
Condition: Thoracic Aortic Diseases
MeSH terms: Aortic Diseases
Study type: Interventional

Summary: 
      A prospective, open-label, non-randomized, interventional clinical study, sponsored by
      Endospan Ltd. Subjects will be followed-up for five years.
    

Detailed description: 
      The purpose of the study is to evaluate the safety and performance of the Single Branch
      Nexus™ Aortic Arch Stent Graft System for the endovascular treatment of thoracic aortic
      pathologies requiring landing in the Aortic Arch (zone 0, zone 1, zone2). The investigational
      device is the Single Branch Nexus™ Aortic Arch Stent Graft System and its designated Delivery
      System.

      Subject population: ten (10) subjects diagnosed with thoracic aortic disease involving the
      aortic arch, and who have appropriate anatomy to accommodate the Single Branch Nexus™
      delivery system in an endovascular procedure. The study will be conducted in 2 clinical sites
      in Germany.
    

Intervention name(s): Nexus™ Aortic Arch Stent graft
Intervention type(s): Device
Intervention description(s): surgical implantation of Nexus™ Aortic Arch Stent graft
Intervention model: Single Group Assignment
Intervention model description: Prospective, open-label, non-randomized, interventional clinical study. All subjects will be treated by implantation of the Single Branch Nexus™ Aortic Arch Stent graft System.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Thoracic Aortic Disease; Thoracic Aneurysm
Hemodynamic Effects of Aliskiren Compared to Captopril on the Kidney in Healthy Volunteers on a Low- and High- Sodium Diet
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will measure the effects of different doses of aliskiren on kidney blood flow and
      function in healthy adults and determine how salt intake affects the response to aliskiren.
    


Intervention name(s): Aliskiren; Aliskiren plus placebo; Aliskiren; Aliskiren plus placebo
Intervention type(s): Drug; Drug; Drug; Drug
Other intervention name(s): SPP100; SPP100
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: aliskiren, renal hemodynamics, hormonal response, renin pathway, RAAS biomarkers
Safety, Tolerability, and Pharmacokinetics of a Single Intravenous Infusion of XTMAB-16 in Healthy Adult Participants
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-center, randomized, double-blind, placebo-controlled, first-in-human, single
      intravenous (IV) infusion of XTMAB-16 (formerly referred to as KBMAB-16) in normal healthy
      male and female participants.
    

Detailed description: 
      A total of 24 normal healthy adult participants will be enrolled and assigned into 2
      treatment cohorts with 12 participants (9 on XTMAB-16 and 3 on placebo) in each cohort.
      Participants will receive a single IV infusion of 2 mg/kg or 4 mg/kg of XTMAB-16 or placebo
      on Day 1.
    

Intervention name(s): XTMAB-16 2mg/kg; Placebo; XTMAB-16 4mg/kg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Biological XTMAB-16 IV infusion single dose; Placebo; IV infusion single dose; Biological XTMAB-16 IV infusion single dose
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
An Alternative Dosing Schedule of Varenicline for Smoking Cessation
Condition: Smoking Cessation
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to explore the use of an prolonged alternative dosing schedule
      using varenicline for smoking cessation leading to greater quit rates and higher rates of
      continuous abstinence.
    

Detailed description: 
      This pilot study will utilize a two group randomized design. Adult smokers who are motivated
      to quit smoking will be randomized to one of two treatment groups. Both groups will receive
      brief support counseling. During a one-week baseline and the 4-week pre-quit period smoking
      rate, smoking satisfaction, withdrawal, and craving will be assessed on a daily basis.
    

Intervention name(s): varenicline; placebo
Intervention type(s): Drug; Drug
Intervention description(s): variable dosing schedule; placebo
Other intervention name(s): Chantix
Intervention MeSH terms: Varenicline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: smoking cessation; varenicline; smoking cessation treatment
A Comparison of Cotton and Flocked Swabs for Vaginal Self Collection
Condition: Human Papillomavirus Infection
MeSH terms: Papillomavirus Infections
Study type: Interventional

Summary: 
      The purpose of this study is to compare the performance of cotton and flocked swabs for
      vaginal self-sampling.
    

Detailed description: 
      Vaginal self-sampling for Human Papillomavirus (HPV) testing has been proposed as an
      efficient method cover hard-to reach populations in developing countries. While the recent
      cheap cotton swabs have traditionally been used for deoxyribonucleic acid (DNA) detection,
      recent studies have questioned their efficacy by reporting the superiority of the more
      expensive flocked swabs.

      The objective of this study is to compare the performance of cotton vs flocked swabs for
      cellular retrieval and HPV DNA quantification after vaginal self-sampling.

      A total of 120 women will be recruited. Inclusion criteria will be as follows: 21 years of
      age or older, attending the colposcopy clinic, understanding the study procedures and able to
      comply with the study protocol. Pregnant women, those having previously had a total
      hysterectomy, and women with ongoing menstruation will be excluded. Each woman will collect
      two different vaginal self samples: one with the cotton swab and one with the flocked swab.
      Subsequently, a flow cytometric analysis, as well as a real time PCR analysis and a cytologic
      evaluation for specimen adequacy will be run on each sample. Agreement between the two
      methods will be calculated using the kappa statistic (κ).
    

Intervention name(s): Vaginal swab
Intervention type(s): Device
Intervention description(s): Vaginal cell collection will be performed with the two types of indicated swab.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Internet-delivered CBT for Adolescents With OCD: A Randomized Controlled Study
Condition: Obsessive-Compulsive Disorder
MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Study type: Interventional

Summary: 
      The effect of Internet-delivered Cognitive Behavior Therapy (ICBT) on adolescents (12 to 17
      years) with Obsessive-Compulsive Disorder is studied. Participants are randomized to either
      ICBT or a no-treatment condition. We expect ICBT to be superior over the no-treatment
      condition.
    

Detailed description: 
      The primary objective of this study is to test the efficacy of Internet-delivered cognitive
      behavior therapy (ICBT) for adolescents (12 - 17 years) with OCD. We aim to conduct a
      randomized controlled study with N = 66 participants. Participants will be randomly assigned
      to ICBT or a wait list condition, either lasting 12 weeks. The primary outcome measure is the
      Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS). Study participants will be
      followed up 3 and 12 months after treatment. ICBT is expected to yield significantly better
      symptom reduction than the wait list condition.
    

Intervention name(s): Internet-delivered Cognitive Behavior Therapy
Intervention type(s): Behavioral
Intervention description(s): The treatment consists of standard cognitive behavior therapy for obsessive-compulsive disorder and is delivered via an internet plattform and regular therapist contact several times per week via email and telephone. The treatment is 12 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: OCD; adolescents; pediatric; internet; online; CBT
A Study to Investigate the Efficacy and Safety of Cannabidiol (GWP42003-P; CBD) as Adjunctive Treatment for Seizures Associated With Lennox-Gastaut Syndrome in Children and Adults
Condition: Epilepsy; Lennox-Gastaut Syndrome
MeSH terms: Seizures; Lennox Gastaut Syndrome; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the efficacy of GWP42003-P as adjunctive treatment in reducing the number of drop
      seizures when compared with placebo, in participants with Lennox-Gastaut Syndrome (LGS).
    

Detailed description: 
      This study was a 1:1 randomized, double-blind, 14-week comparison of 20 milligram [mg] per
      kilogram [kg] per day [mg/kg/day] of GWP42003-P versus placebo. The treatment period
      consisted of a 2-week titration period followed by a 12-week maintenance period. The study
      determined the efficacy, safety and tolerability of GWP42003-P compared with placebo. The
      dose was recommended by the Data Safety Monitoring Committee (DSMC) after assessment of
      safety and pharmacokinetic data from Part A of study GWEP1332. The first participants
      enrolled into this study after the DSMC reviewed the safety data from Part A of study
      GWEP1332. Following study completion, all participants were invited to continue to receive
      GWP42003-P in an open label extension (OLE) study (under a separate protocol).
    

Intervention name(s): GWP42003-P 20 mg/kg/day Dose; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): GWP42003-P was presented as an oral solution containing 100 mg/milliliter (mL) cannabidiol (CBD) in the excipients sesame oil and anhydrous ethanol (79 mg/mL) with added sweetener (0.5 mg/mL sucralose) and strawberry flavoring (0.2 mg/mL).; Placebo was presented as an oral solution containing 0 mg/mL CBD in the excipients sesame oil and anhydrous ethanol (79 mg/mL) with added sweetener (0.5 mg/mL sucralose) and strawberry flavoring (0.2 mg/mL).
Other intervention name(s): Cannabidiol; Epidiolex
Intervention MeSH terms: Cannabidiol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cannabidiol; CBD; Epidiolex; GWP42003-P
Volumetric Study of the Buttocks After Flap Augmentation in Buttocks Lifting
Condition: Weight Loss
MeSH terms: Weight Loss
Study type: Observational

Summary: 
      The development of bariatric surgery, its effectiveness and the reduction of complications
      are at the origin of massive weight loss, the corollary of which has been a clear increase in
      the demands of treatment of sequelae of weight loss.
    


Intervention name(s): gluteal augmentation with flap in circumferential body lift
Intervention type(s): Procedure
Intervention description(s): classic circumferential bodylift surgery, using two different well-known flaps for gluteal augmentation
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        patients after massiv weight loss who come in toulouse or montpellier hospital to take care
        of slimming effects
      
Keywords: plastic and reconstructive surgery; gluteal ptosis; platipygia
A Double-blind, Randomized Controlled Study in CD20-positive Diffuse B Cell Non-Hodgkin's Lymphoma Subjects
Condition: DLBCL
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a prospective international, multi-center, randomized, double-blind controlled study
      designed to assess and compare the pharmacokinetics, pharmacodynamics and the safety of
      MabThera® and TL011, in combination with CHOP in previously untreated patients with diffuse
      large B cell lymphoma.
    


Intervention name(s): TL011; Rituximab
Intervention type(s): Biological; Biological
Intervention description(s): 375 mg/m2 iv every 3 weeks for 8 cycles; 375 mg/m2 iv every 3 weeks for 8 cycles
Intervention MeSH terms: Rituximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: DLBCL; pharmacokinetics; pharmacodynamics
Bioequivalence Study of Oseltamivir Phosphate and TAMIFLU Under Fed Condition in Healthy Volunteers
Condition: Bioequivalence
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is to evaluate the bioequivalence of Oseltamivir Phosphate Capsules 75 mg versus
      TAMIFLU 75 mg capsules administered as 75 mg capsules in healthy volunteers under Fed
      condition.
    


Intervention name(s): Oseltamivir Phosphate 75 mg capsules; Tamiflu capsules 75 mg
Intervention type(s): Drug; Drug
Intervention description(s): Capsules, 75 mg, single, oral dose; Capsules, 75 mg, single, oral dose
Intervention MeSH terms: Oseltamivir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
PRIMM Trial (Phone Reminder for IMMunization)
Condition: Immunization
Study type: Interventional

Summary: 
      The purpose of this study is to determine if in a rural setting of Ondo State, Nigeria, a
      customized automated telephone and email immunization reminder system will be feasible,
      acceptable, and significantly improve immunization utilization rates.
    

Detailed description: 
      Background: Worldwide, vaccine preventable diseases account for 29% of all deaths between 1
      month and 5 years, underscoring the importance of immunizations. In Nigeria, routine
      childhood immunization rates are unacceptably inconsistent and low, ranging from 35-85% at 14
      weeks and 10-37% for all routine immunizations at 12-24 months.

      GAP: The feasibility, acceptability and utility of an automated phone immunization reminder
      system have never been explored in this rural setting of Nigeria.

      HYPOTHESIS: Given ~90% of the adult population in Nigeria uses a mobile phone, a customized
      mHealth immunization reminder system will be feasible and acceptable; and will significantly
      improve immunization rates in this rural setting of Ondo State, Nigeria.

      METHODS: A prospective randomized controlled trial study design will be utilized. This study
      will recruit parents of healthy newborn infants delivered at Mother and Child Hospital Ondo,
      who live in Akure or Ondo Town and plan to receive their immunizations at Mother and Child
      Hospital Ondo.

      DATA ANALYSIS: The proportion of immunization visits between intervention and control groups
      will be compared using a two-sided, two sample test of proportions with p <0.05 being
      significant. Secondary analysis will focus on the predictive value of social demographic
      variables on immunization rates.
    

Intervention name(s): A customized windows® software application
Intervention type(s): Other
Intervention description(s): A customized windows® software application with the ability to send automated voice call, SMS and email reminder about due dates for childhood routine immunizations.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Other
Keywords: Phone Appointment Reminder; Immunization Rates; mHealth
SEPREVEN: a Stepped-wedge Randomised Controlled Trial
Condition: Intensive Care Units, Neonatal; Misadventures to Patients During Surgical and Medical Care; Catheter-related Bloodstream Infection (CRBSI) Nos; Quality of Healthcare; Ventilator Adverse Event; Nosocomial Pneumonia; Immature Newborn; Skin Lesion; Extravasation Injury; Nasal Injury; Intubation Complication; Medication Administered in Error; IV Catheter Nos Deep Venous Thrombosis
MeSH terms: Sepsis; Healthcare-Associated Pneumonia; Thrombosis; Venous Thrombosis; Wounds and Injuries
Study type: Interventional

Summary: 
      Adverse events are frequent in Neonatal Intensive Care Units' (NICU) patients and account for
      a high morbidity and mortality. Possible severe adverse events are central line associated
      bloodstream infections (CLABSI), ventilator and catheter associated adverse events and
      medication errors. Severity of the patient's outcome after an adverse event can be classified
      using the National Coordinating Council for Medication Error Reporting and Preventing (NCC
      MERP) Index for categorizing medication errors.

      The study will test the hypothesis that rates of adverse events in NICU patients will be
      reduced by the implementation of an educational program for the NICU caregivers (nurses and
      physicians), consisting of strategies for recognizing and preventing adverse events in their
      unit. These strategies will be oriented to prevent CLABSI, medication errors, skin and nasal
      complications and ventilator and catheter-associated adverse events.

      This trial has a stepped wedge cluster design, in which the NICUs from 12 hospitals in France
      will be randomized to the timing of implementation of the educational program.

      In order to describe the adverse events occurring during the study period, an anonymous
      voluntary adverse event reporting system will be provided to the caregivers of the
      participating units. A nested study will examine how caregivers communicate with the
      patients' parents in case of adverse event (disclosure or not, and caregivers' reasons).

      The rates of adverse events will be measured retrospectively using a neonatal NICU trigger
      tool.
    


Intervention name(s): Education program for NICU caregivers
Intervention type(s): Behavioral
Intervention description(s): standardized educational program : learning how to retrospectively analyze causes of a medical error in the NICU in order to prevent it (compulsory)
implementation of a central line maintenance bundle and checklist, of a central line insertion bundle and checklist and of a daily goals bundle and checklist. (compulsory)
poster for prevention of extravasation injuries
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Adverse event; Neonatal Intensive Care Unit; Catheter-related Bloodstream Infection (CRBSI) nos; Extravasation injury; Medication error; Central venous catheter complication; Unprogrammed extubation
The Expression Heparanase in Term and Preterm Placentas
Condition: Preterm Birth
MeSH terms: Premature Birth
Study type: Observational

Summary: 
      Heparanase is an endo-β-glucuronidase that cleaves heparin-sulfate (HS) side chains of
      heparan sulfate proteoglycans, an integral constituent of the extra cellular matrix (ECM).

      This study aims to investigate the association between heparanase expression in the human
      placenta and preterm birth (PTB) .

      The investigators hypothesize that an abnormal placentation causes relative placental
      ischemia that induces higher rates of heparanase expression.
    


Intervention name(s): Placental analysis
Intervention type(s): Other
Intervention description(s): Analysis of placenta to determine expression of heparanase
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pregnant women attending our obstetrical unit