bioihbjkbjnl/mcl2 huggingface dataset:
Study to Compare Different Formulations of AZD3355
Condition: Gastroesophageal Reflux Disease
MeSH terms: Gastroesophageal Reflux
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to compare different formulations of AZD3355 in regard to
      possible adverse events such as sensations of numbness, tinglings and heat in the skin.
    


Intervention name(s): AZD3355
Intervention type(s): Drug
Intervention description(s): Single dose
Other intervention name(s): Lesogaberan
Intervention MeSH terms: Lesogaberan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Reflux Inhibitor; GERD; formulations
The Relationship Between Left Atrial Pressure and Cardiac Function After Atrioventricular Node Ablation
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      Effects of left atrial pressure-guided ventricular rate changes on cardiac function after
      atrioventricular node ablation combined with left bundle branch pacing
    

Detailed description: 
      Effects of left atrial pressure-guided ventricular rate changes on cardiac function after
      atrioventricular node ablation combined with left bundle branch pacing. For patients with
      non-valvular atrial fibrillation who received atrioventricular node ablation combined with
      left bundle branch pacing in our hospital, a left atrial pressure catheter was used to
      monitor atrial pressure during the operation, and a lower average atrial pressure was
      obtained by adjusting the pacing frequency of the pacemaker. In a randomized controlled
      manner, the postoperative echocardiography, cardiothoracic ratio, cardiac function, etc. were
      compared between patients without atrial pressure monitoring and those who received atrial
      pressure adjustment, in order to clarify the effect of left atrial pressure-guided
      ventricular rate adjustment on atrioventricular node ablation combined with left bundle
      Benefit of pacing patients.
    

Intervention name(s): left atrial pressure regulation
Intervention type(s): Procedure
Intervention description(s): For patients after atrioventricular node ablation combined with left atrial appendage closure, the regulation of left atrial pressure can be controlled by adjusting the frequency of pacemaker.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Atrial fibrillation;; atrioventricular node ablation;; left bundle branch pacing
Effect of Information About the Benefits and Harms of Mammography on Women's Decision Making
Condition: Breast Cancer Screening
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      The aim of this study is to assess the effect of receiving information about the benefits and
      harms of mammography screening on informed choice, decisional conflict, intention to
      participate in the Early Detection of Breast Cancer Program (EDBCP), and satisfaction. The
      primary outcome is informed choice about breast screening (adequate knowledge, and
      consistency between attitudes and intentions). The sample of participants is composed by 400
      women from Catalonia and the Canary Islands (Spain) who will receive their first invitation
      to participate in the EDBCP of the Public Health Service in a period of 2-4 months.
    

Detailed description: 
      The selected women will receive a letter of invitation with information about the study. In
      the following 1-2 weeks they will receive a phone call to confirm that they have received the
      mailed letter and to assess the inclusion criteria. If they agree to participate in the
      study, they will be asked for informed consent. All the participants will receive a first
      questionnaire, the pre-intervention survey (10-15 minutes), via web or regular mail. Trained
      interviewers will collect the responses by phone for women who prefer this method. Once the
      pre-intervention survey is completed, women will receive the leaflet (intervention or
      control) via regular mail. Two weeks later, the participants will be contacted again to
      collect the post-intervention survey (15-20 minutes), via web or by phone. Participation in
      the mammographic exams of the EDBCP will be collected in the three-month period following the
      corresponding invitation letter.
    

Intervention name(s): Decision aid for breast cancer screening; Standard leaflet
Intervention type(s): Other; Other
Intervention description(s): Women in the intervention arm will receive a leaflet with detailed information on the benefits (breast cancer mortality reduction, less intensive treatments) and harms (false positive results and overdiagnosis).; Women in the control arm will receive a standard leaflet that does not mention harms and recommends accepting the invitation to participate in the biennial exams of the EDBCP.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research
Keywords: breast cancer; screening; decision aid; informed choice; decisional conflict
Pelvic Floor Exercises in Patients With Sjögren's
Condition: Sjögren; Sjögren Syndrome
MeSH terms: Sjogren's Syndrome
Study type: Interventional

Summary: 
      When the literature is examined, the positive effects of pelvic floor exercises on sexual
      functions have been supported by studies. However, the effectiveness of pelvic floor
      exercises on pelvic floor problems in women with sjögren has not been examined in the
      literature. The aim of this study is in order to examine the effect of pelvic floor exercises
      on sexual function in women with primer Sjögren Syndrome (pSS), since these negativities
      affect both the quality of life and sexual functions in women with pSS.

      This is a randomized controlled trial examining the effect of 8 weeks of home-based pelvic
      floor exercises on pain, sexual dysfunction and quality of life on women with sjogren's.
    

Detailed description: 
      Demographic information form, HAQ, VAS, Pelvic Pain Impact Questionnaire (PPIQ), Pelvic Floor
      Distress Scale-20, Female Sexual Function Inventory (FSFI), Pelvic Floor Impact Questionnaire
      (PFIQ-7) will be applied to female patients with Sjögren's who meet the inclusion
      criteria.After the initial evaluation, patients will be randomized to intervention and
      control groups. The intervention group will be taught home exercises including fast and slow
      contraction and keeping the muscles around the pelvic floor in different positions (sitting,
      standing, lying) and will be asked to do them every day for 8 weeks according to the
      determined protocol. For eight weeks, the patients will be supported by the phone by the
      physiotherapist and at the same time, they will be checked whether they do the exercises. The
      control group will be given training on pelvic floor anatomy. At the end of eight weeks,
      patients will be given a final evaluation and the results will be analyzed.
    

Intervention name(s): Pelvic floor exercises
Intervention type(s): Other
Intervention description(s): The participants in the intervention group will be taught exercises involving strengthening the muscles around the pelvic floor in sitting, standing and lying positions by a physiotherapist who has been trained in women's health for 4 years and will be asked to perform them as home exercises every day for 8 weeks. The exercises are as follows:
They will be asked to tighten the muscles around the urethra, vagina and rectum as hard as possible, upwards and inwards (from the bottom up) and hold it in this way for 8-10 seconds. It will be applied in different positions as in the table.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Intervention group will perform pelvi floor exercises at home, control group will take education session
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Sjögren; Pelvic floor exercises
Effect of Neuromuscular Blockade on Pulmonary Complications in Elective Cardiac Surgery
Condition: Neuromuscular Blockade; Postoperative Complications
MeSH terms: Postoperative Complications
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators will conduct a prospective, randomized trial to assess the impact of
      neuromuscular blockade on early (<72 hours post-ICU admission) postoperative respiratory
      complications in cardiac surgical patients. The study will compare continual neuromuscular
      blockade with cisatracurium to a single dose of succinylcholine during general anesthesia for
      cardiac surgery.
    

Detailed description: 
      Residual neuromuscular blockade during the immediate postoperative period is an important
      patient safety issue. Although used to facilitate the technical performance of surgery,
      clinical studies have associated neuromuscular blockade (NMB) with increased incidence of
      postoperative respiratory complications. This effect is likely mediated by residual
      neuromuscular blockade interfering with airway tone and respiratory effort, leading to
      postoperative pneumonia, atelectasis or aspiration. However, the vast majority of these
      studies have involved non-cardiac patient populations, yet patients undergoing cardiac
      surgery are even more susceptible to the detrimental effects of residual neuromuscular
      blockade for a number of reasons. Despite widespread utilization of paralysis during cardiac
      surgery, very little is known about residual neuromuscular blockade in patients following
      cardiac surgery. Previously published clinical studies date from over a decade ago or are
      based on retrospective databases from non-cardiac surgery patients, precluding generalizable
      conclusions. Given the substantial role of neuromuscular blockade in the traditional
      management of cardiac surgical patients, prospective data is needed to determine the veracity
      of this association as well as the surgical tolerability of protocols that minimize
      intraoperative paralysis. The investigators will conduct a prospective, randomized trial to
      assess impact of neuromuscular blockade on early (<72 hours post-ICU admission) postoperative
      respiratory complications.
    

Intervention name(s): Succinylcholine; Cisatracurium
Intervention type(s): Drug; Drug
Intervention description(s): Succinylcholine will be used to facilitate endotracheal intubation for general anesthesia in the operating room. No additional neuromuscular blockade will be provided during general anesthesia.; Cisatracurium will be used to maintain neuromuscular blockade during general anesthesia.
Other intervention name(s): Suxamethonium; Nimbex
Intervention MeSH terms: Cisatracurium; Succinylcholine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Postoperative Pulmonary Complications; Residual Neuromuscular Blockade; Cardiac Surgical Procedures
Investigation of Anti-obesity Properties of Lactobacillus Sakei in Obese Human Subjects
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      In this study, we are going to investigate the efficacy of Lactobacillus Sakei on reduction
      of fat mass assessed by DEXA compared to plaebo.
    

Detailed description: 
      We are going to enroll subjects whose BMI is equal to higher than 25, and randomly assigned
      study material or placebo at 1:1 ratio. The treatment duration is 12 weeks.
    

Intervention name(s): Lactobacillus sakei
Intervention type(s): Dietary Supplement
Intervention description(s): 1 pack contained 5 x 109 cfu
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Pilot Study of a New MiraLax® Dose Formulation For Use in Constipated Children
Condition: Constipation
MeSH terms: Constipation
Study type: Interventional
Phase: Phase 4

Summary: 
      To evaluate patient acceptance of a new MiraLax dose formulation in children currently
      treated with polyethylene glycol 3350 powder for treatment of constipation.
    

Detailed description: 
      To evaluate patient acceptance of a new MiraLax dose formulation in children currently
      treated with polyethylene glycol 3350 powder for treatment of constipation.
    

Intervention name(s): MiraLax
Intervention type(s): Drug
Intervention MeSH terms: Polyethylene glycol 3350
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: constipation; pediatric
Bioequivalence Study of Metformin Hydrochloride Tablets 1000 mg Tablets of Dr. Reddy's Laboratories Limited Under Fasting Condition
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objectives of this study are:

      To compare the single dose bioavailability of Metformin Hydrochloride 1000 mg tablets (Dr.
      Reddy's Laboratories Ltd., Generics, India) with Glucophage (Metformin Hydrochloride) 1000 mg
      tablets (Bristol-Myers Squibb, USA) in 52 + (2 standby) healthy, adult, human subjects under
      fasting conditions.

      To monitor adverse events and to ensure the safety of subjects.
    

Detailed description: 
      Open label, balanced, randomized, two-treatment, two-period, two-sequence, single
      dose,crossover bioequivalence study with at least 07 days of washout period between each drug
      administration under fasting conditions.
    

Intervention name(s): Metformin; Glucophage
Intervention type(s): Drug; Drug
Intervention description(s): Metformin Tablets 1000 mg; Glucophage 1000 mg tablets of Bristol-Myers Squibb
Other intervention name(s): Glucophage Tablets 1000 mg
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Supplementary Intake of Vitamin D During 12 Weeks Strength Training in Younger and Older People
Condition: Muscle Strength; Tendon Elasticity; Muscle CSA; Tendon CSA; VDR Receptor
Study type: Interventional

Summary: 
      The aim is to investigate the importance of vitamin D levels to achieve the effect of
      strength training. If we can show that vitamin D has an effect of training, the ultimate goal
      is to find out why and how vitamin D affects muscle.

      This would potentially have important implications for public health. Since a large number of
      populations, including elderly, are shown to have too little vitamin D and also has low
      muscle strength, it will be essential that these people added vitamin D in relation to
      training and rehabilitation.
    


Intervention name(s): 12 weeks Strength exercise training
Intervention type(s): Other
Intervention description(s): Training 3 times a week, leg extensions and leg press
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Acceptance and Commitment Therapy (ACT) for Anxious Cancer Survivors
Condition: Cancer
Study type: Interventional

Summary: 
      This randomized clinical trial compares group acceptance and commitment therapy (ACT) to
      usual care for cancer survivors experiencing anxiety following the end of cancer treatment.
    


Intervention name(s): Acceptance and Commitment Therapy (ACT) Group; Usual Care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): A 7-session Acceptance and Commitment Therapy (ACT) group intervention; Check in with clinical social worker at oncology care site and obtain list of supportive resources
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Cancer survivors
A Clinical Trial to Evaluate a Recombinant Staphylococcus Aureus Vaccine (Escherichia Coli) in Healthy Adults
Condition: Staphylococcus Aureus Infection
MeSH terms: Staphylococcal Infections; Escherichia coli Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      Before this study, there will be an open-label, dose-escalation pilot study with a total of
      30 participants with 10 per dosage group. The aim of the pilot study is to explore the
      preliminary safety of an experimental recombinant staphylococcus aureus vaccine.

      This is a single center, double-blind, placebo control, dose-escalation phase 1 clinical
      trial. This study will determine the safety and side-effect profile, and immunogenicity of an
      experimental recombinant staphylococcus aureus vaccine. The study will be carried out
      following a dose-escalation method from the low dosage to the high dosage, i.e. the higher
      dosage vaccine could only be administrated after the first seven-day safety of the lower
      dosage vaccine is confirmed after safety observation.
    


Intervention name(s): Low dosage of Staphylococcus aureus vaccine (15µg/0.6ml); Middle dosage of Staphylococcus aureus vaccine (30µg/0.6ml); High dosage of Staphylococcus aureus vaccine (60µg/0.6ml); Placebo
Intervention type(s): Biological; Biological; Biological; Biological
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Relationship of Motor Skill Competency and Physical Fitness to Physical Activity in Elementary School Students
Condition: Child Behavior
Study type: Interventional

Summary: 
      This study examined how well elementary students demonstrated motor skill competency as a
      result of participating in the evidence-based quality physical education program and
      investigated relationships between levels of health-related physical fitness and physical
      activity in school-aged children.
    


Intervention name(s): New physical education instructions
Intervention type(s): Behavioral
Intervention model: Single Group Assignment
Masking: None (Open Label)
Pediatric Philadelphia Positive Acute Lymphoblastic Leukemia
Condition: Leukemia, Pediatric
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether Dasatinib when added to standard
      chemotherapy is effective and safe in the treatment of pediatric philadelphia chromosome
      positive acute lymphoblastic leukemia
    


Intervention name(s): Dasatinib
Intervention type(s): Drug
Intervention description(s): Tablets, Oral, 60 mg/m2, Once daily, 2 years or until unacceptable toxicity
Other intervention name(s): Sprycel
Intervention MeSH terms: Dasatinib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Optimization of EKG Method for Long Term Central Venous Catheter Tip Placement
Condition: Vascular Access Complication
Study type: Interventional
Phase: Phase 4

Summary: 
      Intravenous electrocardiographic guidance (IVECG) is a safe, reliable and accurate technique
      to correctly position the catheter tip. The investigators sought to evaluate the superiority
      of the P-maximal (P-max) wave compared to the P-submaximal (P-submax) wave in obtaining a
      more correct, safer and longer lasting device placement, with a lower incidence of
      complications and secondary misplacement.
    

Detailed description: 
      This prospective randomized trial was designed to observe the placement of long term iv
      catheters obtained with the IVECG method. Patients were randomised into 2 groups: in group A
      the catheter tip was placed in correspondence to the P-max, in group B in correspondence to
      the P-submax. We followed up the tip position by measuring the variation of its distances
      from the tracheal carina on multiplanar reconstructions of volumetric CT scans taken within a
      month (T0) and a year (T1) from the port implant.
    

Intervention name(s): P-Max; P-Submax
Intervention type(s): Device; Device
Intervention description(s): tip placement in correspondence to the P-Max on the ECG; tip placement in correspondence to the P-Submax on the ECG
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: chemo port; intravenous electrocardiographic guidance; P maximal wave; P submaximal wave; catheter tip
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (Explores What the Body Does to the Drug), and Pharmacodynamics (Explores What a Drug Does to the Body) of JNJ-38431055 in Volunteers With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess the safety, tolerability, pharmacokinetics (explores what the body
      does to the drug), and pharmacodynamics (explores what a drug does to the body) of
      JNJ-38431055 in volunteers with type 2 diabetes mellitus.
    

Detailed description: 
      This is a double-blind (neither physician or participant knows name of the assigned study
      drug), placebo-controlled (substance containing no medication), crossover study in male and
      female volunteers with type 2 diabetes mellitus. For each volunteer, the study consists of a
      screening phase (up to 45 days), a run-in phase during which volunteers discontinue their
      oral hypoglycemic drugs (28 days), a treatment phase during which volunteers will continue to
      be off their oral hypoglycemic drugs (28 days) and will receive 4 single dose study
      treatments in a randomized (study sequence assigned by chance) sequence, and a follow-up
      phase (10 days). After the follow-up phase volunteers will restart their oral hypoglycemic
      drugs. During the treatment phase there will be at least 7 days between each of the 4
      treatments. The four treatments will be Dose 1 of JNJ-38431055, Dose 2 of JNJ-38431055,
      sitagliptin (Januvia), and placebo. The following safety evaluations will be taken throughout
      the study: Electrocardiogram (an ECG is a painless procedure that gives a picture of the
      electrical activity of the heart), Blood pressure, heart rate, and blood samples for
      laboratory tests. The primary outcome will be incremental glucose after an oral glucose
      tolerance test. Study drug will be administered as single oral doses separated by at least 7
      days. The four treatments will be Dose 1 of JNJ-38431055, Dose 2 of JNJ-38431055, sitagliptin
      (Januvia), and placebo.
    

Intervention name(s): JNJ-38431055 Dose 1; Sitagliptin 100 mg; Placebo; JNJ-38431055 Dose 2
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Liquid suspension/solution of JNJ-38431055 administered as a single dose; Capsule containing 100 mg of sitagliptin administered as a single dose.; Placebo suspension/solution and Placebo capsule administered as single doses; Liquid suspension/solution of JNJ-38431055 administered as a single dose
Intervention MeSH terms: Sitagliptin Phosphate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Diabetes Mellitus, Type 2