bioihbjkbjnl/mcl2 huggingface dataset:
The BEACH Interview Study- Pregnant and Breastfeeding Mothers
Condition: Pediatric Obesity; Recruitment
MeSH terms: Pediatric Obesity
Study type: Observational

Summary: 
      Interview pregnant and breastfeeding mothers in the Gainesville, FL area to optimize;
      clinical study recruitment and retention, patient-centered outcomes, and stool collection
      procedures.
    

Detailed description: 
      This is an interview study that will enroll mothers during 28 weeks or greater of pregnancy
      and assess recruitment, patient-centered outcomes, and stool collection procedures via
      individualized interviews and data collection. Participants will be recruited from the
      greater Gainesville, FL area. Data collection will include questionnaires/surveys as well as
      minimal risk non-invasive biological samples such as stool, human milk, saliva, vaginal swab,
      and urine collection. Participants will be seen at a location convenient for them.
    

Intervention name(s): Pregnant Mothers Interview; Breastfeeding Mothers Interview
Intervention type(s): Other; Other
Intervention description(s): Pregnant mothers will be interviewed and asked to provide feedback on common strategies used for recruitment, challenges that would preclude them from enrolling and participating in CRTs, their preferences for incentives, data collection, bio-specimen collection and preferences for methods related to non-invasive sample collection.
Data collection for pregnant mothers includes Clinical Health Update (3rd trimester) and Physical Activity questionnaires.
The following will be collected from mothers during the interview: self-reported behavioral data, maternal human milk (HM), stool, urine, saliva, and vaginal swab.; Breastfeeding mothers will be interviewed and asked to provide feedback on common strategies used for recruitment, challenges that would preclude them from enrolling and participating in CRTs, their preferences for incentives, data collection, bio-specimen collection, and preferences for methods related to non-invasive sample collection.
Data collection for breastfeeding mothers includes Clinical Health update (post-natal), Infant Feeding, and Physical Activity questionnaires.
The following will be collected from mothers during the interview: self-reported behavioral data, maternal human milk (HM), stool, urine, saliva, and vaginal swab.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The research team will recruit pregnant women (n = 30) and breastfeeding mothers' (n = 30)
        paired with infant (n=30) to participate in individual, in-depth, semi structured, and
        audio-recorded interviews.
      
Biospecimen description: 
      Non-invasive biospecimens include stool, saliva, blood, urine, human milk, and vaginal swab.
    
Keywords: Retention; Lactation; Human milk; Pregnancy; Clinical Research Studies; BEACH
A Study to Assess the Pharmacokinetics, Metabolism and Excretion Routes of ASP3652 in Man, After Administration of 14C Radio Labeled ASP3652
Condition: Healthy Subjects; Pharmacokinetics of ASP3652
Study type: Interventional
Phase: Phase 1

Summary: 
      This study measures how much of the trial drug enters the body and how long it takes for the
      body to remove it via the feces and urine. In addition, the different breakdown products
      after a single oral dose of radio-active ASP3652 will be identified.
    

Detailed description: 
      This is an open-label, one-period, single-dose study with 14C labeled ASP3652.

      Screening takes place between Day 22 to Day 2, and subjects are admitted to the clinic on Day
      -1.

      On the morning of Day 1, each subject receives a single oral dose of 14C-labeled ASP3652.
      Blood, urine and feces samples for analysis of 14C radioactivity are collected until at least
      120 h after dosing. Blood samples for the analysis of ASP3652 and metabolites are collected
      until 120 h after dosing.

      The subjects remain in the clinic until Day 6 (or up to Day 13 in case discharge criteria are
      not met on Day 6) and return for an End of Study Visit (ESV) 7 to 14 days after (early)
      discharge.
    

Intervention name(s): ASP3652
Intervention type(s): Drug
Intervention description(s): oral
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Pharmacokinetics; ASP3652; 14C radio-labeled; Phase 1
Safety and Efficacy of Bilateral Superficial Cervical Plexus Block in Thyroidectomy
Condition: Pain; Postoperative
Study type: Interventional
Phase: Phase 2

Summary: 
      With thyroid surgery being performed as an ambulatory procedure, most recent studies
      concerning post thyroidectomy analgesia are focused on regional techniques such as bilateral
      superficial cervical plexus block (BSCPB) and bilateral combined superficial and deep
      cervical plexus block. But, data regarding the efficacy of BSCPB are controversial. Hence the
      investigators compared the efficacy of BSCPB with 0.25% bupivacaine with or without clonidine
      in thyroidectomy, as preemptive analgesia.

      The hypothesis was bupivacaine with the addition of clonidine would help in reducing
      postoperative pain and thereby reduce the need for postoperative analgesia.
    

Detailed description: 
      To find out if addition of BSCPB to general anesthesia with bupivacaine with or without
      clonidine prolongs the time needed for postoperative analgesic and facilitate to perform
      thyroidectomy as a day care procedure and to see if clonidine reduces postoperative nausea
      and vomiting.
    

Intervention name(s): 0.9% Normal saline; Bupivacaine; Bupivacaine with clonidine (combination)
Intervention type(s): Drug; Drug; Device
Intervention description(s): Saline; Bupivacaine - amide local anesthetic, maximum recommended dose is 2 mg/kg duration 2 - 4 hours of sensory anesthesia up to 24 hours; Bupivacaine - amide local anesthetic, maximum recommended dose is 2 mg/kg duration 2 - 4 hours of sensory anesthesia up to 24 hours
Clonidine - 0.5 - 1 microgram/ kg
Other intervention name(s): Saline; Marcaine; Sensoricaine; Marcaine (for bupivacaine); Sensoricaine (for bupivacaine)
Intervention MeSH terms: Clonidine; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: cervical plexus block; thyroidectomy; postoperative analgesia
Pharmacokinetic Drug Interaction Study Between Gemigliptin and Glimepiride in Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of the study was to investigate the pharmacokinetic drug interaction between
      gemigliptin and glimepiride in healthy male subjects after oral administration concomitantly
      and each alone.
    


Intervention name(s): Gemigliptin and Glimepiride; Glimepiride
Intervention type(s): Drug; Drug
Intervention description(s): Gemigliptin 50mg (qd) on Day1~Day6 and Gemigliptin 50mg (qd) and Glimepiride 4mg (qd) on Day7; Glimepiride 4mg (qd) on Day1
Intervention MeSH terms: Glimepiride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy and Safety of Azimilide for the Treatment of Patients With Atrial Fibrillation
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional
Phase: Phase 3

Summary: 
      Atrial fibrillation (abnormal rhythm in the upper chamber of the heart) is a common
      supraventricular arrhythmia (abnormal heart rhythm) for which antiarrhythmic therapy is often
      prescribed. The primary goals of therapy are to maintain sinus rhythm (normal heart rhythm)
      and to reduce the occurrence of episodes of atrial fibrillation. Azimilide may have an effect
      on increasing the time to first recurrence of symptomatic atrial fibrillation or atrial
      flutter and symptomatic paroxysmal supraventricular tachycardia (other types of abnormal
      heart rhythms).

      This double-blind, placebo-controlled study is designed to evaluate the efficacy and safety
      of azimilide compared with placebo in maintaining sinus rhythm in patients who require
      cardioversion (electric shock to correct heart rhythm) to reduce atrial fibrillation. Once
      this phase of the study is completed, a second phase with a different study design will be
      conducted. The second phase is an open-label follow-up phase to the study. This follow-up
      phase will continue to evaluate the long-term efficacy and safety of a daily oral dose of
      azimilide in patients who complete the double-blind, placebo-controlled phase of this study.
    


Intervention name(s): Azimilide Dihydrochloride; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 125 mg azimilide tablets once a day for 3 days in hospital and 125 mg azimilide tablets once a day for 6 months as outpatient; placebo tablets once a day for 3 days in hospital and placebo tablets once a day for 6 months as outpatient
Intervention MeSH terms: Azimilide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Pharmacokinetic Profiles of Metformin With DW1029M
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Phase I clinical study to evaluate DW1029M influence the pharmacokinetic profiles of
      Metformin after oral administration in healthy male volunteer
    

Detailed description: 
      A Randomized, open-label, multiple-dose, crossover phase I clinical study to evaluate DW1029M
      influence the pharmacokinetic profiles of Metformin after oral administration in healthy male
      volunteer
    

Intervention name(s): DW1029M 1200mg and Metformin 1000mg; Metformin 1000mg
Intervention type(s): Drug; Drug
Intervention description(s): Metformin 500mg 1 Tablet and DW1029M 300mg 2 Tablets b.i.d. for 7days; Metformin 500mg b.i.d. for 7 days
Other intervention name(s): Concomitant of DW1029M 1200mg and Metformin 1000mg; Diabex tab. 500mg
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: healthy
ELEONOR STUDY: Insulin Glulisine in Type 2 Diabetes Mellitus.
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      -  The primary objective of the present study is to verify the superiority of Telecare
           program vs. standard SMBG program in terms of mean HbA1c value (- 0,5%) at end-point.

        -  The secondary objectives of the study are the assessment of: total daily dose of
           insulin, changes in glycaemic and lipid profile, frequency of hypoglycaemias, changes in
           weight, health-related quality of life, cost-effectiveness of Telecare program vs.
           common ambulatory program; general safety (adverse event profile, other routine
           laboratory parameters).
    


Intervention name(s): Insulin glulisine; Insulin glargine; Metformin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): individualized, once daily, dose aiming at 2h post-prandial plasma glucose goal < 140 mg/dl (7.8 mmol/l) in the optimized treatment phase, since visit 3, subcutaneous; individualized, once daily, dose to reach mean fasting plasma glucose (FPG) <= 126 mg/dl (7.0 mmol/l), since randomization, subcutaneous; 1000 mg b.i.d, since the qualification phase, oral
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Metformin; Insulin Glargine; Insulin glulisine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Non-interaction Study Between Pregabalin and Tramadol, Administered Individually or Combination, in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The study was carried out in the Clinical Unit and Analytical Unit of the Department of
      Pharmacology and Toxicology of the Faculty of Medicine of the Universidad Autónoma de Nuevo
      León, with the aim of comparing the bioavailability (maximum concentration and area under the
      curve) of an oral formulation containing Pregabalin 150 mg/Tramadol 50 mg in combination with
      the two oral formulations Pregabalin 150 mg or Tramadol 50 mg administered as a single dose,
      in healthy subjects under fasting conditions.
    

Detailed description: 
      The study design was crossover, 3 x 6 x 3, prospective and longitudinal, at a single dose of
      the combination Pregabalin 150 mg/Tramadol 50 mg administered orally versus each component
      administered individually, with three treatments, three periods, six sequences and one
      elimination period (wash out) of 7 days in 30 healthy subjects, under fasting conditions. The
      objective of the study was to characterize the pharmacokinetic parameters, maximum plasma
      concentration (Cmax), area under the curve (AUC), time to achieve Cmax (tmax), elimination
      constant (Ke), and elimination half life (t1/2) of Pregabalin and Tramadol after single oral
      dose administration, in combination: Pregabalin 150 mg/Tramadol 50 mg, tablets (Laboratorios
      Silanes S.A. de C.V.) versus each component individually managed, as well as to establish the
      frequency and type of events presented after the administration of a single dose of the
      formulations.
    

Intervention name(s): Fixed dose combination Pregabalin 150 mg / Tramadol 50 mg; Pregabalin 150mg; Tramadol 50 mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Pregabalin/Tramadol (Laboratorios Silanes S.A. de C.V.), Pharmaceutical Form: Tablet Dosage: 150 mg / 50 mg Administration way: oral; From Pfizer S.a. de C.V. Pharmaceutical Form: Capsule Dosage: 150 mg Administration way: oral; From Grünenthal de México, S.A. de C.V. Pharmaceutical Form: Capsule Dosage: 50 mg Administration way: oral
Other intervention name(s): P/T; Preg (Lyrica®); Tram (Tradol®)
Intervention MeSH terms: Pregabalin; Tramadol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pharmacokinetic; Bioavailability; Fixed dose combination; Pregabalin; Tramadol; Acute Pain
A Study Evaluating the Safety and Efficacy of the LentiGlobin BB305 Drug Product in β-Thalassemia Major Participants
Condition: β-thalassemia Major
MeSH terms: Thalassemia; beta-Thalassemia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a non-randomized, open label, multi-site, single-dose, phase 1/2 study in up to 18
      participants (including at least 3 adolescents between 12 and 17 years of age, inclusive)
      with β-thalassemia major. The study will evaluate the safety and efficacy of autologous
      hematopoietic stem cell transplantation (HSCT) using LentiGlobin BB305 Drug Product
      [autologous CD34+ hematopoietic stem cells transduced with LentiGlobin BB305 lentiviral
      vector encoding the human βA-T87Q-globin gene].
    

Detailed description: 
      Subject participation for this study will be 2 years. Subjects who enroll in this study will
      be asked to participate in a subsequent long-term follow up study that will monitor the
      safety and efficacy of the treatment they receive for up to 13 years post-transplant.
    

Intervention name(s): LentiGlobin BB305 Drug Product
Intervention type(s): Genetic
Intervention description(s): Transplant of autologous hematopoietic stem cells transduced with LentiGlobin BB305 lentiviral vector.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: gene therapy; β thalassemia; hemoglobin; anemia; CD34
Fecal Microbiota Transplantation for Relapsing Clostridium Difficile Infection
Condition: Clostridium Difficile Infection
MeSH terms: Infections; Communicable Diseases; Clostridium Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      Randomized open label clinical trial to compare the clinical and microbiological efficacy of
      fecal microbiota transplantation, fidaxomicin, and vancomycin for relapsing Clostridium
      difficile infection
    


Intervention name(s): Fecal microbiota transplantation; Fidaxomicin; Vancomycin
Intervention type(s): Other; Drug; Drug
Intervention description(s): FMT follows 4-10 days of vancomycin 125 mg x 4 daily; Fidaxomicin 200 mg x 2 daily for 10 days; Vancomycin 125 mg x 4 daily for 10 days
Intervention MeSH terms: Vancomycin; Fidaxomicin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Analgesic Efficacy of Forced Coughing During Intrauterine Device Insertion
Condition: Pain
MeSH terms: Cough
Study type: Interventional

Summary: 
      This was a randomized controlled trial of 400 women who attended the outpatient clinic of
      Menoufia University Hospital for copper IUD insertion. The women were randomly assigned to
      cough and control groups.The primary outcome measure was the level of pain experienced at
      different steps of IUD insertion measured by a visual analogue scale (VAS).
    

Detailed description: 
      We conducted this randomized controlled trial at the Department of Obstetrics and Gynecology
      at Menoufia University Hospital, Egypt, from May 2018 to March 2020. Our hospital research
      ethics committee approved this study. We obtained informed consent from all participants
      before initiating any study procedures. CONSORT guidelines were observed and completed.

      We recruited non pregnant women (aged 18-45 years) requesting copper T380A IUD insertion for
      contraception. Eligible women had no prior vaginal delivery or pregnancy termination beyond
      12 weeks, gestation (as patulous cervical os may affect VAS score), any previous deliveries
      had been by cesarean section, they were immediately postmenstrual or 1 week after pregnancy
      termination and they were willing to complete the study questionnaires. All women had to be
      alert, oriented, and cooperative to respond easily to VAS.

      Exclusion criteria were current pregnancy, prior vaginal delivery, history of cervical
      stenosis, current pelvic inflammatory disease, uterine anomalies, undiagnosed abnormal
      uterine bleeding, fibroids distorting the uterine cavity, and patients using chronic NSAIDs
      or on chronic pain medication.

      We randomized participants in a 1:1 ratio to cough and control groups. A statistician not
      directly involved in the study prepared a computer generated randomization list and placed
      the allocation information in sequentially numbered sealed envelopes that were opened
      according to the attendance of the subjects after signing the informed consent.
    

Intervention name(s): forced coughing
Intervention type(s): Other
Intervention description(s): The cough group patients were asked to cough a forced cough during different steps of IUD insertion
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: The cough group patients were asked to cough a forced cough during different steps of IUD insertion
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Intrauterine device, IUD, Pain, Forced coughing
Endocuff-assisted vs. Standard Colonoscopy
Condition: Colon Neoplasms
MeSH terms: Colonic Neoplasms
Study type: Interventional

Summary: 
      The aim of this study is to evaluate Endocuff- assisted colonoscopy in terms of its possible
      additive contribution in the detection of important lesions, namely polyps and cancers,
      compared to standard colonoscopy, in a series of patients undergoing back-to-back screening
      or surveillance colonoscopies in a randomized fashion. Moreover, we aim to assess possible
      changes regarding post-polypectomy surveillance programs following Endocuff utilization.
    

Detailed description: 
      Tandem colonoscopies studies results, show that novel endoscopic technologies detect about
      20% more adenomas than those conventional colonoscopy does (missed adenomas). Since
      Endocuff-assisted colonoscopy cannot be considered as a perfect examination, we hypothesize
      that conventional colonoscopy will detect one third of the missed adenomas that
      Endocuff-assisted colonoscopy detects in a similar setting. Therefore a sample size of 120
      adenomas achieves 80% power to detect an odds ratio of 3.0 using a two-sided McNemar test
      with a significance level of 0.05. The odds ratio is equivalent to a difference between two
      paired proportions of 14% which occurs when the proportion of detected missed adenomas during
      Endocuff-assisted colonoscopy is 21% and the proportion of missed adenomas during
      conventional colonoscopy is 7%. During one year period before the study initiation, our
      colonoscopy performance quality data show that we detect a mean number of adenomas per
      patient equal of 0.7 in a population similar to the one recruited in our study. Therefore,
      172 patients overall will be required to detect 120 adenomas. Given the uncertainty of our
      estimation and in order to cope with patients exclusions, withdrawals and unexpected
      incomplete colonoscopies, we decided to recruit 200 patients.

      A more extensive description regarding the investigators study is provided in the following
      fields.
    

Intervention name(s): standard colonoscopy; Endocuff-assisted colonoscopy
Intervention type(s): Procedure; Procedure
Intervention description(s): examination of the colon with a conventional colonoscope; examination of the colon with Endocuff-assisted colonoscopy
Other intervention name(s): conventional colonoscopy; Endocuff
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: colonoscopy; adenoma detection rate; Endocuff-assisted colonoscopy
Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Doses of ACD856
Condition: Alzheimer Disease; Cognition Disorder
MeSH terms: Alzheimer Disease; Cognition Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The multiple ascending dose (MAD) design of the study is based on the aim to study safety,
      tolerability, PK and pharmacodynamics of selected doses of ACD856 in a limited number of
      healthy volunteers.

      ACD856 will be administered orally.
    


Intervention name(s): ACD856; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Multiple daily oral doses of ACD856 will be administered for 7 days in an escalation scheme of dose 1, dose 2 and dose 3. The escalation schedule may be adapted based on evaluation by the internal Safety Review Committee.; Placebo oral solution
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Alzheimer's Disease; Cognition Disorder