bioihbjkbjnl/mcl2 huggingface dataset:
A Randomized, Double-blind, Placebo-controlled Study on the Efficacy and Safety of CVT-E002 in the Treatment of Upper Respiratory Tract Infections in a Pediatric (3-11 Years) Population
Condition: Upper Respiratory Tract Infections
MeSH terms: Infections; Communicable Diseases; Respiratory Tract Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      Parents with children aged 3-11 will participate in this study. About 500 children will take
      part in the study. We expect about half of those children will develop symptoms of a
      respiratory infection. Active participation in this study will last 14 days after a parent
      reports symptoms of a respiratory infection in a participant. Those children who do meet the
      study criteria of symptoms will then be randomly placed (like a flip of a coin) into one of 2
      groups to take either COLD-FX® or placebo for 3 days. A placebo will look exactly like
      COLD-FX® but contains no active ingredients. The participant has an equal chance of being
      placed in either of the above groups. The study is double-blind, so neither the participant
      nor the study staff will know which study group the participant was placed in until the study
      is completed. If this information is needed in an emergency at any time throughout the study,
      it is quickly available from the sponsor.

      Participation in the study will be for 14 days after symptoms of a respiratory infection are
      reported to study staff. Your child will take the study product for 3 days, you will complete
      a daily diary, receive 4 phone calls and be seen for a final study visit to review the diary
      and complete a final health check of your child.
    

Detailed description: 
      The primary objective is to assess the efficacy of acute dosing of CVT-E002 in reducing the
      duration of URTI symptoms in children 3-11 years of age.

      The secondary objectives are to asses the efficacy of acute dosing of CVT-E002 in reducing:
      (1) symptom severity; (2) peak CARIFS scores and; (3) absenteeism for participant and/or
      parent/guardian. The ease of administration and the safety of acute dosing of CVT-E002 in
      children 3-11 years of age will also be assessed.
    

Intervention name(s): North American ginseng; Placebo
Intervention type(s): Other; Other
Intervention description(s): 3 day, once daily, dosing; 3 day, once daily dosing
Other intervention name(s): COLD-FX
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: URTI; Natural Health Products
Cognitive Behavior Therapy for Insomnia Delivered by a Therapist or on the Internet
Condition: Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional

Summary: 
      Background: Insomnia is a highly prevalent and disabling disorder where Cognitive Behavior
      Therapy for Insomnia (CBT-I) is established as the best available treatment. Still, only a
      negligible number of patients with insomnia receive this treatment. One potential way of
      improving the dissemination of CBT-I is by using online adaptations of CBT-I. This is a new
      method for delivering CBT-I and it is not known how effective online treatment is compared to
      face-to-face CBT-I. This trial's purpose is to compare face-to-face CBT-I with online CBT-I.
      Because of the great advantage of online treatment in both availability and cost, the trial
      is designed as a noninferiority trial.

      Aim: To test if online CBT-I is noninferior in reducing insomnia complaints compared with
      CBT-I as delivered face-to-face by a therapist.
    


Intervention name(s): Internet CBT-i SHUTi; face-to-face CBT-i
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Computer program SHUTi is based on the same theoretical model of insomnia and involves the same interventions as ordinary CBT-I: a structured treatment focusing on education, behaviors and cognitions. Specifically, CBT-I usually consists of one or more of the following: psychoeducation about sleep, sleep restriction therapy, stimulus control, relaxation techniques, and challenging beliefs and perception of sleep.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cognitive therapy; Behavior therapy; Waiting lists; Therapy, computer-assisted; Internet
Randomized Controlled Study of Postoperative Adjuvant Therapy for Gastric Cancer Using TS-1 or TS-1+PSK
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      A randomized controlled study is conducted on patients with resected gastric cancer assigned
      to postoperative adjuvant therapy of TS-1 alone or PSK combined with TS-1, with the objective
      to examine or validate the outcome, QOL and prognostic factors (host and tumor factors), and
      explore the factors enhancing the antitumor effect of TS-1.
    

Detailed description: 
      The 5-year survival after gastric cancer surgery remains poor as the cancer advances to
      stages II, IIIA, IIIB and IV. Tegafur-gimeracil-oteracil potassium (TS-1) is used as the
      first line treatment for advanced and recurrent gastric cancer. But TS-1 is accompanied by an
      adverse drug reaction of bone marrow suppression that is not readily seen in conventional
      oral fluoropyrimidines. Among randomized controlled trials on postoperative adjuvant
      chemotherapy for gastric cancer, the beneficial results of survival rates using Krestin (PSK)
      in combination with chemotherapy have been reported. With the objective to enhance the
      antitumor effect of TS-1 and to improve the QOL of patients, we have planned to validate the
      clinical significance of combined PSK and TS-1 therapy as postoperative adjuvant therapy for
      gastric cancer, using in principle the TS-1 regimen of 2-week dosing 1-week off for 6 months
      followed by 2-week dosing 2-week off for 6 months.
    

Intervention name(s): Tegafur-gimeracil-oteracil potassium (TS-1); Krestin (PSK)
Intervention type(s): Drug; Drug
Intervention description(s): From 4-8 weeks after surgery to 27-31 weeks after surgery, 80 mg/m2, PO from day 1 to day 14 of each 21 day cycle. Number of Cycles: 8 From 28-32 weeks after surgery to 53-57 weeks after surgery, 80 mg/m2, PO from day 1 to day 14 of each 28 day cycle. Number of Cycles: 7; From 4-8 weeks after surgery to 53-57 weeks after surgery, 3 g/day, PO every day
Other intervention name(s): TS-1; PSK
Intervention MeSH terms: polysaccharide-K; Tegafur
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Gastric Cancer; TS-1; PSK; Disease-free survival; Overall survival
Study to Assess Eradication of Nasal Carriage of Staphylococcus Aureus (SA) With Mupirocin (Bactroban 2% Nasal Ointment)
Condition: Staphylococcal Infection
MeSH terms: Staphylococcal Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will assess the nasal eradication of SA in healthy subjects following treatment
      with mupirocin 2% (Bactroban 2% Nasal Ointment) twice daily for 5 days, by means of a broth
      enriched culture microbial assay. The sensitivities of broth enrichment and plating assay
      methods will be compared. The safety and tolerability of Bactroban 2% Nasal Ointment will
      also be assessed.
    


Intervention name(s): Mupirocin
Intervention type(s): Drug
Intervention description(s): Mupirocin (Bactroban 2% Nasal Ointment) will be administered twice daily for five days in accordance with the SmPC.
Other intervention name(s): Bactroban
Intervention MeSH terms: Mupirocin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Dose-Finding Safety Study Evaluating Remimazolam (CNS 7056) in Patients Undergoing Diagnostic Upper GI Endoscopy
Condition: Procedural Sedation; Endoscopy
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study was to assess the safety and efficacy of CNS 7056 as a procedural
      sedative at three dose levels compared to midazolam during a diagnostic upper GI endoscopy.
    

Detailed description: 
      This was a randomized, double-blind, parallel-group, dose-finding study assessing the safety
      and efficacy of three dose levels of CNS 7056 compared with midazolam in patients undergoing
      diagnostic upper GI endoscopy.

      Patients who met all study entry criteria and completed screening procedures were randomly
      assigned to 1 of 4 treatment groups: CNS 7056 0.10 mg/kg,0.15 mg/kg, or 0.20 mg/kg; or
      midazolam 0.075 mg/kg. Patients received their assigned treatment administered as a single
      intravenous injection by a syringe driver over 1 minute. The endoscopy started when a
      Modified Observer's Assessment of Alertness/Sedation (MOAA/S) score of ≤3 has been reached,
      but no earlier than 90 seconds after Time 0 (the start of study drug injection). Rescue with
      sedative medication (midazolam 1-2 mg) was be permitted at the discretion of the
      administering physician.

      Efficacy assessments consisted of the MOAA/S scores, Aldrete scores, and drowsiness measures
      using a Visual Analogue Scale (VAS). Cognitive function was assessed by the Hopkins Verbal
      Learning Test-Revised™ (HVLT-R™) and memory for the procedure by the Brice Questionnaire.

      Safety assessments included adverse events, physical examinations, vital signs, ECGs, pulse
      oximetry measurements, clinical laboratory tests, and pain on injection using a VAS.
    

Intervention name(s): CNS 7056; Midazolam
Intervention type(s): Drug; Drug
Intervention description(s): Administered as a single intravenous injection by a syringe driver over 1 minute; Administered as a single intravenous injection by a syringe driver over 1 minute
Other intervention name(s): remimazolam; Versed
Intervention MeSH terms: Midazolam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: CNS 7056; Procedural Sedation; Sedation; Endoscopy
A Study to Evaluate Efficacy, Safety and Tolerability of CK-2127107 in Patients With Amyotrophic Lateral Sclerosis (ALS)
Condition: Amyotrophic Lateral Sclerosis
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study was to assess the effect of CK-2127107 (hereafter referred to as
      reldesemtiv) versus placebo on respiratory function and other measures of skeletal muscle
      function in patients with ALS.
    

Detailed description: 
      This was a double-blind, randomized, placebo-controlled, dose ranging study of reldesemtiv in
      patients with ALS. Eligible patients were randomized (1:1:1:1) to receive placebo or one of
      three doses of reldesemtiv (150, 300, or 450 mg twice daily) for 12 weeks. Randomization was
      stratified by riluzole concomitant use/non-use and edaravone concomitant use/non-use.
      Concomitant riluzole and edaravone were allowed as long as the riluzole dose had been stable
      for at least 30 days prior to screening and edaravone had been taken for 2 cycles prior to
      screening; these drugs could not be initiated during the study.

      A total of 7 study visits were planned: screening, Day 1 (first dosing day), Weeks 2, 4, 8,
      and 12, and follow-up (4 weeks after the last dose of study drug). Study drug (placebo or
      reldesemtiv) was to be taken twice daily, approximately 12 hours (± 2 hours) apart and within
      2 hours following a meal.
    

Intervention name(s): Reldesemtiv; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral tablet; Oral tablet
Other intervention name(s): CK-2127107
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Amyotrophic Lateral Sclerosis; ALS; CK-2127107; Reldesemtiv
Cell Therapy in HFpEF
Condition: Heart Failure With Normal Ejection Fraction
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of the study is to investigate safety and efficacy of transendocardial
      CD34+ cell therapy in patients with HFpEF by evaluating changes in myocardial structure and
      function, patient exercise capacity and clinical outcome.

      The safety end-points include serious adverse events (SAEs), defined as any serious event
      that may result in persistent or significant disability or incapacity and included death,
      heart transplantation, sustained ventricular arrhythmia (ventricular tachycardia or
      ventricular fibrillation), and heart failure exacerbation requiring hospitalization.
    

Detailed description: 
      In all patients, peripheral blood stem cells will be mobilized by daily subcutaneous
      injections of G-CSF (10 mcg/kg, divided b.i.d) for 5 days. Peripheral blood stem cells will
      then be collected with Miltenyi cell separator (Miltenyi Biotech, Germany) and the magnetic
      cell separator Isolex 300i (Nexell Therapeutics Inc., California, USA) will be used for the
      immunomagnetic positive selection of the CD34+ cells.
    

Intervention name(s): Cell Therapy
Intervention type(s): Biological
Intervention description(s): Electro-anatomical mapping will be performed using the Biosense NOGA system (Biosense-Webster, Diamond Bar, California). Local diastolic function will be assessed by a novel algorhithm that allows for the measuring local ventricular relaxation times at each of the sampling points. Target areas for cell delivery will be defined as the myocardial segments with the evidence of local diastolic dysfunction and myocardial hibernation. Transendocardial delivery of cell suspension in the SC Group will be performed with MyoStar® (Biosense Webster) injection catheter. Each patient will receive 20 injections of 0.3 mL of stem cell suspension.
Intervention model: Sequential Assignment
Intervention model description: The study is designed in a prospective crossover fashion. In Phase 1 of the study, all patients are treated with optimization of medical therapy for 6 months. Thereafter, all patients cross over to Phase 2 of the study, where they receive transendocardial CD34+ cell therapy. Follow-up of Phase 2 lasts for 6 months. At the time of enrollment (6 months before cell therapy), at time of cell therapy, and 6 months thereafter we will perform detailed clinical evaluation, laboratory assays, echocardiography, 6-minute walk test, and measure plasma levels of N-terminal pro B-type natriuretic peptide (NT-proBNP).
Masking: None (Open Label)
Primary purpose: Treatment
A Randomised Trial Using Highly Purified Human Chorionic Gonadotropin (HP-hCG) and Recombinant Human Chorionic Gonadotropin (rhCG) in Women Undergoing Controlled Ovarian Stimulation
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial is investigating the efficacy and safety of highly purified human chorionic
      gonadotropin (HP-hCG) and recombinant human chorionic gonadotropin (rhCG) for triggering of
      final follicular maturation in women undergoing controlled ovarian stimulation
    


Intervention name(s): highly purified human chorionic gonadotropin; recombinant human chorionic gonadotropin
Intervention type(s): Drug; Drug
Other intervention name(s): CHORAPUR; BREVACTID; OVIDREL; OVITRELLE
Intervention MeSH terms: Chorionic Gonadotropin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
The Effects of Using Fertile Chip in Sperm Selection for Intracytoplasmic Sperm Injection in Unexplained Infertility
Condition: Unexplained Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of the current study is to evaluate to effectiveness of sperm selection by using
      fertile chip in unexplained infertile couples on intracytoplasmic sperm injection (ICSI)
      cycles.
    

Detailed description: 
      The aim of the current study is to evaluate to effectiveness of sperm selection by using
      fertile chip in unexplained infertile couples on intracytoplasmic sperm injection (ICSI)
      cycles. On study arm sperm selection will be performed by using special microchannel system
      which is called fertile chip (FC) without using sperm wash procedure. This FC system leads to
      select lineer motile progressive sperm selection. In control group, sperm selection will be
      performed by classical way which sperm will be undertaken to sperm wash by gradient method.

      After selection of sperm in both arms, ICSI will be performed. The outcomes of ICSI schedule
      will be assesed by fertilization and clinical pregnancy rates.
    

Intervention name(s): fertile chip
Intervention type(s): Device
Intervention description(s): a new method for sperm selection on ivf cycles by using microchannel system.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: ICSI; sperm selection; fertile chip; ıcsı outcomes
Ketamine Effect After Laparoscopic Gastric Reduction: A Randomized, Double-Blinded, Placebo Controlled Study
Condition: Pain; Obesity; Hypoxia
MeSH terms: Hypoxia
Study type: Interventional
Phase: Phase 4

Summary: 
      Laparoscopic surgery for gastric reduction is frequently associated with high levels of
      postoperative pain. Postoperative pain is very often treated with opioids. However large
      doses of opioids can result in respiratory depression with hypoxemia especially in high risk
      patients with obstructive sleep apnea. since a large group of patients undergoing surgery for
      gastric reduction surgery also have obstructive sleep apnea, it is expected that these
      patients are also at high risk for postoperative respiratory depression and hypoxemia.

      Intraoperative ketamine has been used as an effective multimodal agent to reduce
      postoperative pain. However, ketamine alone has not been examined to improve postoperative
      pain outcomes in patients undergoing gastric reduction surgery. More importantly, it is
      unknown if the use of intraoperative ketamine can lead to better overall quality of recovery
      in the same patient population. In addition, ketamine has been shown to improve ventilation
      but it remains to be determined if the intraoperative use of ketamine will result in less
      postoperative hypoxemic events.

      The main objective of the current investigation is to examine the effect of intraoperative
      ketamine on postoperative quality of recovery after gastric reduction surgery. The
      investigators hypothesize that subjects receiving ketamine will have a greater global quality
      of recovery score than the ones receiving saline.
    


Intervention name(s): Ketamine; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Group K (ketamine) will receive 0.5mg /kg of ketamine bolus followed by an infusion of 0.5 mg/kg/hour of ketamine throughout the intraoperative period (Adjusted body weight).; Group P (placebo) will receive the same amount of saline.
Other intervention name(s): Ketalar; Sterile .9 Normal Saline
Intervention MeSH terms: Ketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Quality of Recovery 40 Questionaire; Pain; Hypoxia; Gastric Surgery; Obesity; Ketamine
Addiction Remission and Addiction Transfer After Bariatric Surgery
Condition: Obesity
MeSH terms: Behavior, Addictive
Study type: Interventional

Summary: 
      To evaluate addiction remission and addiction transfer after bariatric surgery.
    

Detailed description: 
      A prospective study to evaluate addiction remission and addiction transfer 6 and 24 months
      after primary surgery (sleeve gastrectomy, Roux-en-Y- gastric bypass and One anastomosis
      gastric bypass) in obese patients. A questionnaire evaluating food addiction (Yale Food
      Scale), alcohol addiction (Audit Scale), nicotine addiction (Fagerström Scale), exercise
      addiction (Exercise Addiction Inventory), internet addiction (ISS20) and drug addiction (Drug
      Use Questionnaire) gets completed prior to surgery and 6 and 24 months after surgery.
    

Intervention name(s): Questionnaire
Intervention type(s): Other
Intervention description(s): Every patient who undergo surgery will fill out a questionnaire containing validated scales concerning food, alcohol, nicotine, internet and exercise and drug addiction prior, 6 months and 24 months after surgery.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: addiction remission; addiction transfer
Control of Blood Loss During Caesarean Section
Condition: Complications; Cesarean Section
MeSH terms: Hemorrhage
Study type: Interventional
Phase: Phase 3

Summary: 
      trial of 3 protocols to determine the best one to control blood loss during caesarean section
    

Detailed description: 
      The study population will be divided into 3 groups each containing 200 women:

      Group (A): 200 patients will receive 5-IU oxytocin bolus over 3 minutes after delivery of the
      baby.

      Group (B): 200 patients will receive 5-IU oxytocin bolus over 3 minutes and 30-IU oxytocin
      infusion in 500 ml 0.9 % saline over 4 hours after delivery of the baby.

      Group (C): 200 patients will receive misoprostol 800 micrograms intrauterine, placed manually
      on the bottom of the uterine cavity after delivery of the placenta and cleaning of the
      cavity.

      Operative blood loss will be estimated in theatre based on the volume in the suction bottle
      and the weight of swabs used. We will record blood loss up until the time the woman will be
      discharged from the theatre recovery ward.

      Hemoglobin level and haematocrit value will be done as follow:-

        1. After admission of each case in the pre-operative period.

        2. Immediately post- operative.

        3. 24 hours post- operative.
    

Intervention name(s): oxytocin; Misoprostol
Intervention type(s): Drug; Drug
Intervention description(s): group I : oxytocin 5 IU bolus over 3 minutes after delivery of the baby group II : oxytocin 5 IU bolus over 3 minutes after delivery of the baby and oxytocin infusion in 500 ml 0.9% saline over 4 hours; misoprostol intrauterine 800 microgram placed intrauterine after delivery of the baby & the placenta
Other intervention name(s): syntocinon; cytotec
Intervention MeSH terms: Misoprostol; Oxytocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: caesarean section, intrapartum haemorrhage
Effect of Renal Impairment on Evobrutinib Pharmacokinetics (PK)
Condition: Renal Impairment
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will investigate the PK and safety of evobrutinib in subjects with different degree
      of renal impairment as compared to subjects with normal renal function.
    


Intervention name(s): Evobrutinib
Intervention type(s): Drug
Intervention description(s): Subjects will be administered a single oral dose of evobrutinib under fasting conditions.
Other intervention name(s): MSC2364447C; M2951
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Renal Impairment; Evobrutinib; Pharmacokinetics