bioihbjkbjnl/mcl2 huggingface dataset:
CKD-330 Drug-Drug Interaction Study (Amlodipine)
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate a pharmacokinetic drug interaction and safety of
      Amlodipine between free combination of Amlodipine and Candesartan and Amlodipine monotherapy.
    


Intervention name(s): Amlodipine 10mg; Amlodipine 10mg/Candesartan 32mg
Intervention type(s): Drug; Drug
Intervention description(s): Amlodipine 10mg 1T, PO, QD for 9days; Amlodipine 10mg 1T, PO, QD for 9days/Candesartan 32mg 1T, PO, QD for 9days
Other intervention name(s): Norvasc Tab. 10mg; Norvasc Tab. 10mg/Atacand Tab. 32mg
Intervention MeSH terms: Amlodipine; Candesartan; Candesartan cilexetil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
COMPARISON OF OBSTETRIC AND NEONATAL OUTCOMES OF ADOLESCENT PREGNANCİES
Condition: Adolescent Development; Pregnancy Related
Study type: Observational

Summary: 
      ABSTRACT

      Adolescent pregnancy rates are gradually increasing in the recent decades. As a reason of war
      nutritional difficulties, language differences and difficulty in applying to the health
      institution causes lack of prenatal care. As a reason of absence of prenatal care, associated
      medical complications can occur. 525 adolescent women who gave birth to singletons agreed to
      participate in this study. Data on maternal demographic and obstetric characteristics as well
      as neonatal outcomes were analyzed. In conclusion, adolescent pregnancy continues to be an
      important social problem due to the health support needs. However, the results of our present
      study are important in terms of showing that the perinatal care is quietly improved in
      Turkey.
    


Intervention name(s): vaginal delivery
Intervention type(s): Other
Intervention description(s): normal vaginal spontaneous delivery
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        adolescent pregnancy outcomes
Healthy Lifestyles for People With Intellectual Disabilities
Condition: Mental Retardation; Developmental Disabilities; Intellectual Disabilities
MeSH terms: Intellectual Disability; Developmental Disabilities
Study type: Interventional

Summary: 
      Relatively few health promotion and disease prevention programs have included or targeted
      people with disabilities, and even fewer have focused on individuals with intellectual
      disabilities.

      The long-term objectives of the Healthy Lifestyles for People with Intellectual Disabilities
      Study (HLID) are to increase the health of persons with intellectual disabilities by
      establishing the efficacy of a health promotion program and promoting its adoption. The HLID
      Study is based in the Center on Community Accessibility (CCA) at Oregon Health & Science
      University. The mission of CCA is to increase the health and health-related quality of life
      of persons with disabilities.

      A pilot study conducted by CCA has established the effectiveness of the Healthy Lifestyles
      (HL) intervention among a cross-disability population in increasing health behavior adoption.
      The specific aim of the HLID Study is to test the efficacy of the HL program specifically
      with adults with intellectual disabilities.

      The HLID Study uses a randomized control study design. The HL intervention will be
      administered to 75 adults and will compare results to those of an additional 75 adults who
      receive no intervention. Measurement will include anthropometric assessments to measure
      impacts on overweight and obesity, as well as self-report measures of healthy behaviors,
      health status, health care utilization, and secondary conditions. Results will be shared with
      research participants, presented through professional conferences and newsletters, and
      published in peer-reviewed journals with the assistance of community partners.
    


Intervention name(s): Healthy Lifestyles Curriculum
Intervention type(s): Behavioral
Intervention description(s): Three consecutive days of six hours of training comprised of instruction and participant interaction.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: mental retardation; downs syndrome; autism; autism spectrum disorder; cerebral palsy; developmental disability; developmental disabilities; intellectual disability; intellectual disabilities; health promotion; disease prevention; physical health; emotional health; behavioral health; mental health; spiritual health; prevention
Unravelling Targets of Therapy in Bronchial Thermoplasty in Severe Asthma
Condition: Asthma; Bronchial Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      Approximately 5% of asthma patients suffer from severe asthma that is characterized by
      frequent asthma exacerbations resulting in significant morbidity and excessive utilisation of
      health care resources. Therefore, there is a strong need for improved therapeutic strategies
      for these patients. Insight in the pathogenesis and molecular pathways active in severe
      asthma is crucial to reach this goal.

      Bronchial Thermoplasty (BT) is a novel, innovative device-based treatment of severe asthma
      that is based on local, radiofrequent energy delivery in larger airways during bronchoscopy.

      Hypothesis:

      BT-induced clinical improvement in severe asthma is a consequence of reduction in airway
      smooth muscle (ASM) mass and (contractile/immunomodulatory) function, inflammation, neural
      innervation and/or vascular integrity resulting in altered airway remodelling. BT target
      identification and severe asthma phenotyping are critical for improved patient selection for
      BT and fundamental to discover novel, specific signalling pathways active in severe asthma.
    

Detailed description: 
      This study has a two-fold purpose:

        1. to unravel the targets of BT in severe asthma (how does it work?) which is fundamental
           for better patient selection (who benefits most?) and further improvement of BT
           technology and novel asthma therapy development (how to treat better?). These objectives
           can only be achieved by linking patient-reported outcomes to airway structure/function,
           which is the principal aim of the study proposed.

        2. to investigate clinical outcome analyses
    

Intervention name(s): Bronchial thermoplasty; Alair system (Boston Scientific, USA)
Intervention type(s): Procedure; Device
Intervention description(s): Bronchial thermoplasty (BT) will be performed using the Alair system (Boston Scientific, USA). Patients will undergo 3 bronchoscopy procedures with BT at least 3 weeks apart. Treatment sessions are designed to address different lobes of the lung with the right lower lobe treated during the first bronchoscopy, the left lower lobe treated during the second bronchoscopy, and both the right and left upper lobes treated in the third and final bronchoscopy. The right middle lobe and proximal airways including RC2 are left untreated.; The alair system consist of a controller and a bastket catheter.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Bronchial thermoplasty; Severe asthma
Capecitabine and Oxaliplatin in Treating Patients With Advanced or Metastatic Colorectal Cancer
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Combining more than one drug may kill more tumor cells.

      PURPOSE: Phase I/II trial to study the effectiveness of combining capecitabine and
      oxaliplatin in treating patients who have advanced or metastatic colorectal cancer that
      cannot be surgically removed.
    

Detailed description: 
      OBJECTIVES: I. Determine the maximum tolerated dose of capecitabine when combined with
      oxaliplatin in patients with chemotherapy naive or thymidylate synthase inhibitor pretreated
      unresectable, advanced or metastatic colorectal cancer. II. Determine the safety profile,
      toxicity, and efficacy of this regimen in these patients. III. Determine the complete and
      partial remission rates, time to treatment failure, and overall survival of patients treated
      with this regimen.

      OUTLINE: This is a dose escalation, multicenter study of capecitabine. Patients are
      stratified by pretreatment status (any pretreatment vs chemotherapy naive vs thymidylate
      synthase inhibitor pretreatment). Phase I : Patients receive oxaliplatin IV over 2 hours on
      day 1 and oral capecitabine every 12 hours on days 1-14. Treatment repeats every 3 weeks in
      the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive
      escalating doses of capecitabine until the maximum tolerated dose (MTD) is determined. The
      MTD is defined as the highest dose at which 2 or more of 6 patients experience dose limiting
      toxicity. Phase II: Patients receive capecitabine at the feasible dose. The feasible dose is
      defined as the dose immediately preceding the MTD from phase I. Patients are followed every 3
      months for 1 year, and then every 6 months thereafter until death.

      PROJECTED ACCRUAL: Approximately 18 patients will be accrued for phase I of the study and a
      total of 27-68 patients (14-25 thymidylate synthase inhibitor pretreated patients and 13-43
      chemotherapy naive patients) will be accrued for phase II of the study.
    

Intervention name(s): capecitabine; oxaliplatin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Capecitabine; Oxaliplatin
Primary purpose: Treatment
Keywords: stage III colon cancer; stage IV colon cancer; stage III rectal cancer; stage IV rectal cancer; recurrent colon cancer; recurrent rectal cancer
Stimulant Medication Effects on Auditory Sensitivity in Teens With ADHD
Condition: Attention Deficit Hyperactivity Disorder; Attention Deficit Disorder; Attention Deficit Disorder With Hyperactivity
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Observational

Summary: 
      The aims of this study are to evaluate auditory sensitivity in teenagers with ADHD using
      acoustic reflex thresholds (ART) and to examine the effects of ADHD stimulant medication on
      ART.
    

Detailed description: 
      Attention-deficit/hyperactivity disorder (ADHD) is the most common neurodevelopmental
      disorder in children. Besides core ADHD symptoms (inattentiveness, hyperactivity,
      impulsivity), ADHD also affects the ability to perceive and process sounds. Both
      hypersensitivity and hyposensitivity to loud sounds are common symptoms in ADHD patients.
      With stimulant medication, individuals with ADHD become more tolerant of loud noise than when
      they were non-medicated. It remains unknown exactly how stimulant medication alters the
      loudness perception. The proposed study will use the acoustic reflex to objectively measure
      auditory sensitivity to loud sounds. The aims of this study are to evaluate auditory
      sensitivity in patients with ADHD using acoustic reflex thresholds (ART) and to examine the
      effects of ADHD stimulant medication on ART. Eligible participants will participate in two
      sessions (off-med and on-med conditions) conducted on the same day. ADHD patients will be
      asked to come to the laboratory before taking their ADHD medication. The investigators will
      repeat three tests before and after taking stimulant medication. The investigators will also
      conduct screening tests during and between the first and second sessions. The investigators
      will compare a difference between the two independent groups (ADHD vs. Control) and compare a
      within subject difference between medication conditions (on-med vs. off-med).
    

Intervention name(s): ADHD stimulants, for example, amphetamine, dexmethylphenidate, dextroamphetamine, methylphenidate
Intervention type(s): Drug
Intervention description(s): Both ADHD and control groups of subjects will participate in 2 sessions (on-med and off-med conditions) conducted on the same day. ADHD group will be asked to come to the laboratory in the morning before taking their morning ADHD stimulant medication. They will be tested before and after taking their ADHD medication (off-med and on-med conditions). The investigators will observe changes between the two conditions.
Other intervention name(s): Adderall; Focalin; Ritalin; Vyvanse; Concerta
Intervention MeSH terms: Methylphenidate; Amphetamine; Adderall; Dexmethylphenidate Hydrochloride; Dextroamphetamine
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Adolescents with ADHD and typically developing adolescents
      
Keywords: stimulant medication
Zentangle on Psychological Well-being
Condition: Mental Health Wellness
Study type: Interventional

Summary: 
      This study will examine the effects of Zentangle as an intervention for reducing stress and
      enhancing psychological wellbeing among Hong Kong adults. Zentangle is a mindful doodling
      process in which participants draw repetitive, structured patterns on small pieces of paper.
      The patterns consist of combinations of dots, lines, and curves. Zentangle is developed in
      2003 by two Americans, and this concept is still new to many people. Some studies suggested
      that Zentangle can be effective in reducing stress and anxiety, but the number of research
      papers on Zentangle is limited. Although Zentangle has become a rather popular stress relief
      activity in Hong Kong recently due to its easiness to learn and minimal tool requirement,
      there is no related study on its effectiveness in promoting psychological wellbeing in Hong
      Kong.
    

Detailed description: 
      This study will be a pilot randomized controlled trial on the effects of Zentangle as an
      intervention for reducing stress and enhancing psychological wellbeing among Hong Kong
      adults. Prior to all study procedures, an online informed consent (with phone support) will
      be obtained from potential participants. Around 30 eligible participants will be randomly
      assigned to either the Zentangle group or the waitlist control group in a ratio of 1:1.
    

Intervention name(s): Zentangle
Intervention type(s): Behavioral
Intervention description(s): Zentangle is a mindful doodling process in which participants draw repetitive, structured patterns on small pieces of paper. The patterns consist of combinations of dots, lines, and curves.
Other intervention name(s): Mindful doodling
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The randomization will be performed by an independent assessor using a computer-generated list of numbers. A 2-hour online Zentangle class will be delivered to the Zentangle group by a certified Zentangle teacher via online webinar. The Zentangle group will complete a short qualitative questionnaire and participate in a 15-minute brief discussion right after the Zentangle class. They will also be encouraged to practice Zentangle daily for two weeks. Both Zentangle group and waitlist control group will complete a set of online questionnaires before the intervention commences, immediately after the intervention and 2 weeks after the intervention. An online Zentangle class will be provided to the waitlist control group after the post-intervention data of the Zentangle group has been collected.
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: Zentangle; Mindful doodling; Mindfulness; Psychological Well-being
A Study to Investigate the PK and Safety of CKD-393
Condition: Type II Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      A clinical trial to investigate the pharmacokinetics and safety after oral administration of
      CKD-393
    

Detailed description: 
      A randomized, open-label, single-dose, two-way crossover clinical trial to investigate the
      pharmacokinetics and safety after oral administration of CKD-393 and co-administration of
      CKD-501, D759 and H053 under fed condition in healthy adults
    

Intervention name(s): CKD-393 formulation I; CKD-393 formulation II; D501, D759, H053
Intervention type(s): Drug; Drug; Drug
Intervention description(s): single, oral administration of 2 tablets under fed condition; single, oral administration of 2 tablets under fed condition; single, oral administration of 1 D501, 1 D759 and 2 H053 under fed condition
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CKD-393; Type II Diabetes
Sugammadex Versus Neostigmine Use in Patients Undergoing Septoplasty Operations
Condition: Nasal Septum Deviation
Study type: Observational [Patient Registry]

Summary: 
      The purpose of this study to determine the effectiveness of sugammadex in septoplasty
      patients whose mask ventilation would be difficult after extubation.
    

Detailed description: 
      Patients undergoing septoplasty operation will be included to this study. After coming to
      operation room all the patients will have standard monitorisation and induction. After
      intubation they will have inhalational anesthesia as maintenance. According to the TOF (train
      of four) measurement all patient will have neuromuscular relaxant if needed. After the
      operation they will be extubated according to TOF or clinical parameters. And time for
      extubation, mask assistance need, any complication, mask difficulty, and time spent in
      postoperative care unit will be recorded. Then the results will be compared, whether
      sugammadex or neostigmine is better for these patients in means of extubation and
      postoperative status.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients undergoing septoplasty operation
Risk Factors for Barotrauma in COVID-19
Condition: Barotrauma; Covid19
MeSH terms: COVID-19; Barotrauma
Study type: Observational

Summary: 
      Barotrauma in mechanical ventilation (MV) is defined as lung damage attributable to the
      application of high airway pressure and is one of the potential mechanisms of
      ventilator-induced lung injury (VILI). Previous studies have shown an increased mortality in
      patients with barotrauma under MV; pneumothorax (PTX) being the most common presentation, but
      it can also present as pneumomediastinum (PM) with or without PTX, with extension to soft
      tissue as subcutaneous emphysema or even as pneumo-retroperitoneum and pneumo-scrotum.

      Traditionally, underlying lung disease or age are known risk factors for non-trauma related
      barotrauma. However, in patients with novel coronavirus disease (COVID-19), the incidence of
      this complication is more common than in non-infected patients, as recently reported. Since
      little is known regarding which are the main risk factors for these events to develop, most
      pathophysiological mechanisms remain unexplained.

      The aim of this study was to determine the risk factors for developing barotrauma in patients
      under MV with COVID-19 associated Acute Respiratory Distress Syndrome (ARDS). Secondary
      objectives were to determine the incidence of barotrauma and its association with mortality.
    


Intervention name(s): No intervention
Intervention type(s): Other
Intervention description(s): No intervention
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with diagnosis of severe SARS-COV2 infection and mechanical ventilation, admitted
        in a single-center community Hospital in Mexico City.
      
Keywords: Barotrauma; COVID-19
(CB-01-02/06) Oral Budesonide-Multi-Matrix System (MMX) 9mg Extended Release Tablets
Condition: Colitis, Ulcerative
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 3

Summary: 
      Open-label, 8 week study, to assess the efficacy and safety of oral Budesonide-MMX 9 mg
      Extended-release Tablets in patients with mild to moderate, active ulcerative colitis who are
      not in remission based on the Ulcerative Colitis Disease Activity Index in study CB-01-02/01
      (parent study [NCT00679432]).
    

Detailed description: 
      Patients who complete the parent study and who do not achieve clinical remission will be
      eligible to receive 8 weeks of open-label treatment with Budesonide-MMX 9mg if they satisfy
      the entry criteria for this study.
    

Intervention name(s): Budesonide
Intervention type(s): Drug
Intervention description(s): One Budesonide-MMX 9 mg tablet will be taken in the morning after breakfast for 8 weeks.
Intervention MeSH terms: Budesonide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ulcerative colitis; Budesonide
A Study Comparing the Efficacy, Safety and Tolerability of Oral Dydrogesterone 30 mg Daily Versus Crinone 8% Intravaginal Progesterone Gel 90 mg Daily for Luteal Support in In-Vitro Fertilization (LOTUS II)
Condition: Female Infertility
MeSH terms: Infertility; Infertility, Female
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this randomized, two-arm and open label study is to demonstrate that the
      treatment of a daily dose of 3x10mg dydrogesterone orally is as effective and safe as the
      daily dose Crinone 8% intravaginal progesterone gel 90 mg for the luteal support in women who
      are unable to conceive a child and are undergoing IVF. The treatment will start on the day of
      oocyte retrieval and continue until pregnancy is negative or until week 12 gestation.

      Patients will be followed during treatment until 30 days after delivery to record any safety
      and tolerability data of the patient and their newborn (s).
    

Detailed description: 
      "This article has been accepted for publication in Human Reproduction published by Oxford
      University Press."
    

Intervention name(s): Dydrogesterone 30 mg; intravaginal progesterone gel 90 mg
Intervention type(s): Drug; Drug
Intervention description(s): Oral Dydrogesterone 10 mg tablets tid
Other intervention name(s): Crinone 8% intravaginal progesterone gel 90 mg
Intervention MeSH terms: Progesterone; Dydrogesterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment