bioihbjkbjnl/mcl2 huggingface dataset:
Assessment of the Safety and Ability of a Once-a-day Dose of an Orally Inhaled Medicine [ie, Glycopyrrolate Inhalation Solution = GIS] to Improve Airflow in the Lungs When Delivered With an Electronic eFlow Nebulizer System in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      The study assessed the safety and ability of several doses of an orally inhaled medicine [ie,
      Glycopyrrolate Inhalation Solution = GIS] to improve airflow in the lungs when delivered with
      an electronic eFlow nebulizer system in patients with Chronic Obstructive Pulmonary Disease
      (COPD). The study was conducted in 12 patients in 2 parts. Part 1 was designed to find the
      once-a- day GIS dose that produced the highest improvement in lung airflow. Part 2 tested the
      GIS dose with the highest improvement in lung airflow and a placebo (ie, no drug) delivered
      by a general purpose nebulizer. The airflow improvements of the same GIS dose were compared
      between the two nebulizer systems to determine what effect the device had on GIS delivery.
    

Detailed description: 
      In Part I, 12 subjects were randomly allocated to one of 2 cohorts, running in parallel. The
      6 cohort 1 subjects received 25 mg and then 200 mg during their treatment periods 1 and 2,
      respectively. The 6 cohort 2 subjects received 75mg, 500mg, and 1000 mg during their
      treatment periods 1, 2, and 3, respectively. During Part II of the study, the same 12
      subjects from Part I were randomized to receive either 200 mg jet or placebo in a 1:1 ratio.
    

Intervention name(s): Glycopyrrolate Inhalation Solution 25mg; Glycopyrrolate Inhalation Solution 75mg; Glycopyrrolate Inhalation Solution 200mg; Glycopyrrolate Inhalation Solution 200mg Jet; Glycopyrrolate Inhalation Solution 500mg; Glycopyrrolate Inhalation Solution1000mg; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 25 μg oral inhalation via eFlow Nebulizer, once daily; 75 μg oral inhalation via eFlow Nebulizer, once daily; 200 μg oral inhalation via eFlow Nebulizer, once daily; 200 μg oral inhalation via inhalation via jet nebulizer, once daily; 500 μg oral inhalation via eFlow nebulizer, once daily; 1000 μg oral inhalation via eFlow nebulizer, once daily; Placebo 0.5 mL oral inhalation via jet nebulizer, once daily
Other intervention name(s): GIS; GIS; GIS; GIS; GIS; GIS
Intervention MeSH terms: Glycopyrrolate; Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Emphysema; Chronic bronchitis; COPD; Chronic Obstructive Pulmonary Disease
Effectiveness of a Natural Ingredient on Obesity
Condition: Overweight and Obesity; High Blood Pressure
MeSH terms: Hypertension; Obesity; Overweight
Study type: Interventional

Summary: 
      randomized, placebo-controlled clinical trial, with two parallel branches whose objective is
      to evaluate the efficacy of the product investigated on blood pressure and fat mass of
      subjects without pharmacotherapy.
    

Detailed description: 
      The subjects that meet the selection criteria will make a total of five visits to the
      research laboratory and will carry out the pre-established tests in the protocol.
      Subsequently, a statistical analysis will be carried out with the variables measured in the
      study to obtain results.
    

Intervention name(s): dietary supplement consumption
Intervention type(s): Dietary Supplement
Intervention description(s): Consumption of the product under study for 84 days, plecebo or experimental product
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study of LY900014 Formulation in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study evaluates a new formulation of LY900014, a drug that lowers blood sugar. It is
      administered by injection under the skin of the abdomen. The study will be conducted in
      healthy people to investigate how quickly and how much LY900014 is absorbed and the effect of
      different doses of LY900014 on blood sugar levels. Side effects and tolerability will be
      documented. The study will last about 6 to 7 weeks for each participant, including screening
      and follow up. Screening is required within 28 days prior to entering the study.
    


Intervention name(s): LY900014; Insulin Lispro
Intervention type(s): Drug; Drug
Intervention description(s): Administered subcutaneously (SC); Administered SC
Other intervention name(s): Ultra-Rapid Lispro
Intervention MeSH terms: Insulin Lispro
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
High Throughput Technologies to Drive Breast Cancer Patients to Specific Phase I/II Trials of Targeted Agents
Condition: Metastatic Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      High sensitivity to targeted agents has been observed in patients whose tumor cells present a
      genetic/genomic deregulation of the target (Kit mutation, ERBB2 amplification, EGFR
      mutations) together with addiction to the given target. More recently, activation of
      "alternative pathways" (Kras mutation, PI3K mutations) have been reported as a common
      resistance mechanism to single agent tyrosine kinase inhibitors (trastuzumab, cetuximab).

      From these data has emerged the hypothesis that identification of the deregulated pathway
      through new molecular tools could allow to propose a more tailored targeted regimen.

      Based on these concepts, numbers of phase I/II trials enrich their populations in patients
      presenting specific molecular alterations.

      High throughput technologies (array CGH, sequencing, gene expression array) identify
      deregulated genes. In addition, these technologies determine whether such genomic alterations
      are single (expected efficacy of single agent) or multiple (rationale for combination). In a
      pilot study that included 135 patients, we recently performed a combination of array CGH and
      hot spot mutation array in order to drive patients into phase I/II clinical trials. This
      study led to the conclusions that high throughput technologies i. are feasible (80%) and
      robust, ii. identify "targetable" genomic alterations in around 40% of samples.

      In the present study, the investigators will perform high throughput technologies to drive
      400 metastatic breast cancer patients into specific phase I/II trials.
    


Intervention name(s): Biopsy
Intervention type(s): Other
Intervention description(s): Breast metastases biopsy
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        women or men with metastatic breast cancer
      
Biospecimen description: 
      Metastasis biopsy and DNA from biopsy
Clinical Study of Asahi ViE Dialyzer in Canada
Condition: Kidney Failure, Chronic
MeSH terms: Renal Insufficiency; Kidney Failure, Chronic
Study type: Interventional

Summary: 
      The purpose of the study is to obtain performance data on the Asahi ViE-21 dialyzer (ViE-21)
      .
    

Detailed description: 
      The objective of the study is to evaluate specific parameters related to ViE-21 performance
      including (A) Performance evaluated by uremic solute removal rates of urea, creatinine,
      albumin and B2-MG, (B) Determination of KUF, (C) Biocompatibility evaluated by WBC, platelet
      and C3a measurements, (D) Type and number of adverse events, (E) Type and number of device
      malfunctions.

      Prospective, open-label, non-randomized, single-armed, controlled study. Each patient shall
      have data collected for six dialysis sessions each on a control dialyzer prior to and after
      36 sessions with the ViE-21. These data shall be the basis of comparison for the ViE-21
      performance.

      These data will be utilized in support of a US Regulatory Submission.
    

Intervention name(s): ViE-21
Intervention type(s): Device
Intervention description(s): The subjects will be undergone three times KUF measurement sessions and three times blood sampling sessions during study period.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Tolerance and Pharmacokinetics Study of MNTX Tablets
Condition: Normal Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a double-blind, randomized, placebo-controlled, phase I study in normal healthy
      volunteers. Study treatment includes single doses of MNTX and placebo. In addition, half of
      each active treatment group is further randomized to a second, replicate dose of MNTX, and
      the placebo group receives an additional placebo dose.
    


Intervention name(s): Oral methylnaltrexone; Oral placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Methylnaltrexone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Effect of Education Given to Prospective Fathers on Daily Care of the Baby and Father-Infant Attachment
Condition: Pathernal Attachment; Effect of Education to Pathernal Attachment
Study type: Interventional

Summary: 
      I am conducting an experimental study examining the bonding between father and baby.
    

Detailed description: 
      The experimental group and the control group (1st group and 2nd group) will be formed by
      randomly selecting the spouses of women who applied to Afşin State Hospital and Elbistan
      State Hospital Gynecology Polyclinic. Fathers in the first group will be met face-to-face
      with powerpoints and visuals, and training will be provided. It is planned to provide a total
      of 3 educations by contacting fathers at the time of birth and 2 months after birth. The
      scope of the 1st education is planned to be about attachment, father-infant attachment, the
      benefits of father-infant attachment to the baby and the father and how this bond can be
      strengthened. Care and feeding of the baby is planned within the scope of the second
      education. In the third education, it is planned to inform the father about spending quality
      time with the baby and its importance. As a result, the first education will be focused on
      more about attachment and its importance, the second education will focus on the importance
      of the father's participation in the care of the baby and the information about care, and the
      last education the importance of the father's taking care of the baby and spending time with
      him. Fathers in the second group will be given a training brochure at the end of the 6th
      month, after the scale is applied. If the baby's health is affected by possible adverse
      events at birth, that father will be excluded from the study. After the birth with the
      fathers, when the baby reaches 6-12 months, face-to-face or phone calls will be applied and
      the father-infant attachment status will be analyzed by statistical analysis. The study will
      be done as pre-test and post-test. Güleç D. and Kavlak O. examined the validity of the
      father-infant Attachment Scale in Turkish society, and they came up with a questionnaire
      consisting of 19 questions in total.

      Detail added (15.06.2021): Power analysis was performed with the study from 5 control groups
      from 5 experimental groups. A total of 58 workers, consisting of 29 experimental and 29
      control groups, were found sufficient for the study
    

Intervention name(s): Education
Intervention type(s): Other
Intervention description(s): Its validity and reliability is a reliable scale in Turkey
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Supportive Care
Keywords: pathernal attachment; baby; father
Improved Automatic CPAP Algorithm to Treat Obstructive Sleep Apnea (OSA)
Condition: Obstructive Sleep Apnea (OSA)
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      The purpose of this study is to compare a modified AutoSet algorithm running on research
      hardware versus the traditional AutoSet algorithm running on an S7 AutoSet Spirit. The study
      will determine if the modified AutoSet algorithm reacts appropriately to obstructive apnoeas
      and hypopnoeas and provides suitable levels of positive airway pressure compared to the S7
      AutoSet Spirit.

      The hypothesis is that the modified AutoSet algorithm will be more efficacious than the
      traditional AutoSet algorithm
    

Detailed description: 
      Subjects in the trial will spend 2 nights in a sleep laboratory being monitored with a full
      montage polysomnograph (PSG) with each of the algorithms providing positive airway pressure
      therapy. The PSG records EEG, EMG, EOG, patient airflow, respiratory effort, blood oxygen
      saturation, and body position.

      In a randomised order each subject will spend one night being treated by the modified AutoSet
      algorithm and a second night being treated by the traditional AutoSet algorithm.

      The subjects will be blinded to which therapy they are receiving and the scorer of the PSG
      will also be blinded to which therapy is being used.
    

Intervention name(s): Modified AutoSet Algorithm; Standard AutoSet Algorithm
Intervention type(s): Device; Device
Intervention description(s): The modified AutoSet algorithm responds to more patient "non-normal" flow types than the standard AutoSet algorithm; The standard AutoSet used for treatment of OSA
Other intervention name(s): Enhanced AutoSet algorithm
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Effect of Oleic Acid on Inflammation Markers and Blood Lipid Metabolites: A Randomised, Double-Blind, Crossover Study
Condition: Inflammation
MeSH terms: Inflammation
Study type: Interventional

Summary: 
      Rationale: The effect of positional distribution of dietary fatty acids on markers of
      inflammation and blood lipids metabolites on diets containing fatty acids such as oleic acid
      that are associated with reduced risk of cardiovascular disease is not widely studied.

      Hypothesis: There would be difference detected in the concentrations of markers of
      inflammation and blood lipid metabolites in human volunteers fed controlled diets.

      Study design: A randomized, double-blind, crossover clinical trial that involves 41 healthy
      volunteers. The volunteers will be selected based on inclusion and exclusion criteria. They
      will consume controlled diets for 5 weeks that provides 15% of energy from protein, 30% of
      energy from fat, and 55% of energy from carbohydrates. Volunteers will be assigned to each
      test diets which is cooked with novel olein, palm stearin or partially hydrogenated soybean
      oil in random order until all three diets has consumed by each person.

      Main study parameters: LDL-cholesterol
    


Intervention name(s): Novel Olein; Novel Olein
Intervention type(s): Other; Other
Intervention description(s): A total of 70g of test oil is incorporated into cooked meal which accounts for 30-35% of calorie intake; A total of 70g of test oil is incorporated into cooked meal which provides 30-35% of calorie
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Inflammation; LDL; Oleic acid; Palmitic acid; trans fatty acid; C-reactive protein
Comparison of Intrathecal Dexmedetomidine Versus Fentanyl as Adjuvants to Bupivacaine on Post-operative Urinary Retention in Knee Joint Arthroscopic Surgeries
Condition: Post-Op Complication
MeSH terms: Urinary Retention; Postoperative Complications
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study was to assess the effect of intrathecally injected 5 µg dexmedetomidine
      or 25 µg fentanyl as adjuvants to bupivacaine in low dose spinal anesthesia for unilateral
      arthroscopic knee surgeries, on post-operative urinary retention (POUR), time needed to reach
      sensory block at the tenth thoracic dermatome (T10), the maximum sensory level achieved, the
      onset of motor block, the intra-operative fluids given, the duration of sensory and motor
      blocks, time to micturition or insertion of an intermittent urinary catheter and the number
      of patients who needed an indwelling (Foley's) catheter. Seventy patients, ASA physical
      status I or II, from 21 to 50 years old, scheduled to undergo unilateral arthroscopic knee
      surgeries under spinal anesthesia, were randomly divided into two equal groups; the
      Bupivacaine- Dexmedetomidine group (BD) patients and the Bupivacaine-Fentanyl group (BF)
      patients.
    


Intervention name(s): hyperbaric bupivacaine and dexmedetomidine; Bupivacaine-Fentanyl group
Intervention type(s): Drug; Drug
Intervention description(s): In a 3 ml syringe, 5 µg dexmedetomidine was added to the 2 ml of 10 mg hyperbaric bupivacaine, to have a total volume of 2.5 ml for intrathecal spinal injection over 3 minute without barbotage; In a 3 ml syringe, 25 μg fentanyl was added to the 2 ml of 10 mg hyperbaric bupivacaine, to have a total volume of 2.5 ml for intrathecal spinal injection over 3 minute without barbotage
Intervention MeSH terms: Fentanyl; Dexmedetomidine; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Diagnostic
Detecting Atrial Fibrillation in Patients With an Embolic Stroke of Undetermined Source (From the DAF-ESUS Registry)
Condition: Fibrillation, Atrial
MeSH terms: Embolic Stroke; Atrial Fibrillation
Study type: Observational [Patient Registry]

Summary: 
      The presence of interatrial block (IAB) is associated with the development of atrial
      fibrillation (AF). The aim of this study was to determine whether P-wave duration and
      presence of IAB before the implantation of a cardiac implantable electronic device (CIED) are
      associated with the presence of atrial high rate episodes (AHRE), during long-term follow-up.
    

Detailed description: 
      The presence of interatrial block (IAB) is associated with the development of atrial
      fibrillation (AF). The aim of this study was to determine whether P-wave duration and
      presence of IAB before the implantation of a cardiac implantable electronic device (CIED) are
      associated with the presence of atrial high rate episodes (AHRE), during long-term follow-up.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients in sinus rhythm, with or without previous paroxysmal AF and with dual-chamber
        pacemakers (PMs), implantable cardioverterdefibrillators (ICDs), and devices for cardiac
        resynchronization therapy (CRT) capable of atrial activity monitoring were included in the
        study
      
Keywords: cardiac implantable electronic devices; interatrial block; P-wave duration
Effect of Open-placebo Intervention on Cycling Performance
Condition: Exercise Performance
Study type: Interventional

Summary: 
      This study evaluates the effect of an open-label placebo intervention on cycling time-trial
      performance.
    

Detailed description: 
      This study investigated the effect of open-placebo on cycling time-trial (TT) performance.
      Twenty-eight trained female cyclists completed a 1-km cycling TT following a control session
      or an open-placebo intervention. The intervention consisted of an individual presentation,
      provided by a medic, in which the concept of open-placebo was explained to the participant,
      before she ingested two red and white capsules containing flour; 15 min later, they performed
      the TT. In the control session, the participant sat quietly for 20 min.
    

Intervention name(s): Open-placebo; Control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Application of the open-placebo intervention; Application of the control session
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Therapeutic Processes and Treatment Outcome in Adolescents With Anxiety Disorders
Condition: Anxiety Disorders
MeSH terms: Anxiety Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to examine the relationship between different aspects of
      cognitive behavior therapy (CBT) and treatment outcome.
    

Detailed description: 
      Anxiety disorders are common among children; if untreated, they can negatively affect
      children's lives. Evidence suggests that CBT can benefit children with anxiety disorders, but
      the causal mechanisms between therapy and beneficial outcomes have not been thoroughly
      investigated.

      Audio and videotaped sessions of children currently receiving CBT and those who received CBT
      in previous trials will be examined. Various rating scales will be used to rate therapeutic
      alliance, child involvement, and therapist flexibility for each session of CBT. To evaluate
      potential process variables that contribute to participant drop-out, this study will compare
      the early process variables for children who complete treatment and for those who discontinue
      treatment.
    

Intervention name(s): Cognitive Behavioral Therapy
Intervention type(s): Behavioral
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Adolescent