bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Evaluate the Effect of the Potent CYP3A4 Inhibitor Itraconazole on the Pharmacokinetics (PK) of TAK-906 in Healthy Participants
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effect of the potent cytochrome P-450 (CYP) 3A4
      inhibitor (itraconazole) on the single-dose PK of oral TAK-906 maleate.
    

Detailed description: 
      The drug being tested in this study is called TAK-906. TAK-906 is being tested in healthy
      participants in order to evaluate the effect of the potent CYP3A4 inhibitor itraconazole on
      the single-dose PK of TAK-906 maleate.

      The study enrolled 12 participants. Participants received the following treatment sequence:

      • TAK-906 maleate 25 mg; Itraconazole 200 mg + TAK-906 maleate 25 mg

      Participants were given an oral dose of TAK-906 in the First Intervention Period which was
      followed by a washout period, after which participants were given Itraconazole solution along
      with TAK-906 orally in the Second Intervention Period.

      This single center trial was conducted in the United States. The overall duration to
      participate in this study was 7 weeks. Participants remained confined in the clinic from Day
      1 up to Day 2 (First Intervention Period) and Day 4 up Day 6 (Second Intervention Period).
      Participants returned for a Follow-up Visit, 10 to 14 days after last dose of study drug.
    

Intervention name(s): TAK-906 Maleate; Itraconazole
Intervention type(s): Drug; Drug
Intervention description(s): TAK-906 capsule; Itraconazole solution
Intervention MeSH terms: Itraconazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Drug Therapy
Effects of Sleep Duration on Eating and Activity Behaviors
Condition: Sleep; Obesity
MeSH terms: Obesity
Study type: Observational

Summary: 
      The purpose of the proposed study is to determine whether the amount children sleep is
      associated with changes in hormones, hunger, motivation to eat, and food intake. Fifty
      children 8-11 years old who sleep 9-10 hours per night will be enrolled for a 3-week study.
      For 1 week each, children will be asked to sleep their typical amount, increase their sleep
      by 1-½ hours, and decrease their sleep by 1-½ hours. Half of the children will be asked to
      increase their sleep first and half to decrease their sleep first. During each week, the
      following will be gathered: sleep duration (measured by actigraphy, which is a small device
      that measures sleep), levels of hormones measured through blood draws, self-reported hunger
      and appetite, food intake (measured by 3 days of 24-hour recall), how motivated children are
      to eat (measured using a computer activity), and child height and weight. We believe that
      when children sleep less they will show changes in hormones associated with hunger and
      appetite, report being hungrier, be more motivated to eat, and eat more food.
    


Intervention name(s): Increase Sleep; Decrease Sleep
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Children are asked to increase their sleep by approximately 1 1/2 hours/night for 1 week.; Children are asked to decrease their sleep by approximately 1 1/2 hours/night.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children ages 8-11 years old recruited from Southeastern New England.
      
Biospecimen description: 
      2 ml of whole blood drawn at each of 3 assessments
    
Keywords: sleep; obesity; children; eating behaviors; activity; leptin; ghrelin
Effect of Preoperative Estrogen Treatment on Connective Tissues of the Pelvic Floor
Condition: Pelvic Organ Prolapse; Menopause
MeSH terms: Prolapse; Pelvic Organ Prolapse
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a study to determine how vaginal estrogen cream given for several weeks before pelvic
      reconstructive therapy will effect elastic fiber assembly in the muscularis layer of the
      vaginal wall. Postmenopausal women with at least Stage 2 pelvic organ prolapse will receive
      either estrogen vaginal cream or placebo cream 6-8 weeks prior to reconstructive surgery. At
      time of surgery, full thickness biopsies will be obtained from a standardized location at the
      top of vagina. The investigators will measure the thickness of the vaginal muscularis,
      elastic fiber number and morphology, and analyze if elastic fiber synthesis or degradation is
      affected by estrogen therapy. The results will provide important data to support a larger
      clinical trial to determine if preoperative and maintenance estrogen therapy alter long-term
      success rates of pelvic reconstructive surgery for pelvic organ prolapse.
    


Intervention name(s): Premarin; Placebo
Intervention type(s): Drug; Other
Other intervention name(s): Conjugated equine estrogen; Placebo cream
Intervention MeSH terms: Estrogens; Estrogens, Conjugated (USP)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Pelvic organ prolapse; Menopause; Estrogen; Premarin
Study to Assess Safety and Tolerability of G17DT in Patients With Colorectal Adenocarcinoma.
Condition: Colorectal Cancer
MeSH terms: Adenocarcinoma
Study type: Interventional
Phase: Phase 2

Summary: 
      Pancreatic, gastric, and colorectal cancers have all been shown to overexpress the gastrin
      gene and to be sensitive to the trophic effects of the gastrin in animal models. The
      hypothesis of this study is that G17DT will elicit specific and high-affinity antibodies that
      will bind gastrin-17, thus preventing the trophic activity of cancer cells.
    


Intervention name(s): G17DT
Intervention type(s): Biological
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
"Investigation of the Relationship Between New Coronary Virus Disease (COVID-19) and Anxiety and Depressive Symptoms in Pregnant Women"
Condition: COVID; Anxiety; Depression, Postpartum
MeSH terms: Depression, Postpartum; Depression; Anxiety Disorders
Study type: Observational

Summary: 
      In our study; Anxiety and depression levels, socio-demographic characteristics of the
      pregnant women who were admitted to our hospital between 25.04.2020-25.07.2020 and treated
      with the diagnosis of covid 19, and the change in anxiety and depression levelsWİTH Beck
      Depression and Anxiety Score after the disease regressed are planned.

      (Beck depression scale contains 10 questions and a total of 1 to 100 points is obtained. High
      score indicates that depression and anxiety are high.) 0-16 points = mild depressive symptoms

      17-29 points = moderate depressive symptoms

      30-63 points = severe depressive symptoms
    

Detailed description: 
      The sociodemographic data form prepared by the researchers will be filled out by interviewing
      the patients who are willing to participate in the study. In addition, Beck Depression Scale,
      Beck Anxiety Scale, State and Trait Anxiety Scale will be given by the participants
      themselves. When the patients come to their first control after discharge, the scales
      specified will be repeated.
    

Intervention name(s): covid-19 positive pregnant women
Intervention type(s): Behavioral
Intervention description(s): It is planned to receive pregnant women who are admitted to the clinic or outpatient clinic and who are offered inpatient follow-up and treatment with the diagnosis of COVID-19.
Pregnant women who do not have covid-19 disease as a control group and who do not have a comorbid disease at similar gestational week will be included in the study. As a control group, covid-19 pcr negative patients will be admitted to our clinic in the same period.
Other intervention name(s): covid-19 negative pregnant women
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Pregnant women with a positive covid -19 pcr test between the ages of 18 and 45 will be
        included in the study and beck and anxiety tests will be performed 3 months after birth.
Siewert Type II Esophageal Adenocarcinoma: Relationship Between Histology and Survival
Condition: Siewert Type II Adenocarcinoma of Esophagogastric Junction
MeSH terms: Adenocarcinoma
Study type: Observational

Summary: 
      In Siewert type II adenocarcinoma, the relationship between adenocarcinoma sub types and
      survival, histologic/biologic patterns related to the presence/absence of gastric greater
      curvature metastases, were investigated.
    

Detailed description: 
      In order to achieve further data on the biological patterns of intestinal and diffuse
      subtypes of esophageal adenocarcinoma (Lauren's classification), on the frequency of gastric
      greater curvature nodal stations and on the clinical relevance, in terms of prognosis and
      survival, of these parameters, a Siewert type II case series of Siewert type II
      adenocarcinomas, submitted to primary (no neoadjuvant therapy) surgical, studied, operated
      upon and followed up, were analysed. According to histologic patterns, cases were ordered in
      intestinal and diffuse adenocarcinoma sub types (Lauren's classification)and distinguished in
      Barret's, cardiopyloric, gastric types.
    

Intervention name(s): Total Gastrectomy
Intervention type(s): Procedure
Intervention description(s): The esophagus was resected at the arch level of the azygos vein, a frozen section of the resection margin was routinely performed to achieve a proximal clean resection margin. The surgical specimen was comprehensive of distal esophagus, stomach and omentum. Digestive tract continuity was established with Roux-en-Y esophagojejunostomy. Lymphadenectomy was extended to the thoracic stations R 2-4, 7-8-9, and L 4, numbered according to the Mountain's classification [39] (Suppl. File 2 Figure A) and to the abdominal stations 1-12, numbered according to the Japanese Research Society for Gastric Cancer (JRSGC) 1998 classification.
Other intervention name(s): Distal Esophagectomy
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        One hundred fifty four Siewert type II cases were enrolled: 124 men (80.5%), 30 women
        (19.5%), median age 65.5 (interquartile range 58-71); Intestinal type 91 (59%) and Diffuse
        type 63 (41%).
      
Biospecimen description: 
      Surgical specimen
    
Keywords: esophageal cancer; adenocarcinoma of the esophagus; esophageal surgery
Study Concerning Relationship Between Mixed Venous Saturation (SvO2) and Balance
Condition: Surgery
Study type: Observational

Summary: 
      It is the purpose of the investigators to investigate the possible relationship between fall
      in the amount of Oxygen in the blood and disturbances of balance-function before and after
      surgery.
    

Detailed description: 
      It has been shown that the mixed venous saturation (SvO2) is usable as a parameter of fluid
      status. It has also been suggested that there is a connection between SvO2 and blood flow in
      tissue , and that a SvO2 of less than 40% is a sign of tissue hypoxia.

      Recently it has been shown that patients going through heart surgery experience a drop in
      SvO2 during early mobilization.This drop lasts throughout the mobilisation process.

      We want to investigate whether the same mechanism applies to patients going through other
      types of surgery, and whether there is a connection between a drop in SvO2 and orthostatic
      function.

      This will be done by making 3 tests. One pre-operatively,one six hours post-operatively and
      one 18-24 hours after surgery.

      The tests will consist of:

        1. 10 min of rest.

        2. 3 min of sitting upright on the side of the bed. C. 3 min of standing on the floor. D.
           10 min of rest.

      Between each position a venous blood sample will be taken. Also 1 blood sample will be taken
      at the end of surgery.

      Continuous measurements by the Finapres system wil be made throughout the test-sequence to
      investigate changes in BP, SV, TPR and HR.

      At the same time the patient will be pain-scored when taking a new position.
    

Time perspective: Prospective
Keywords: Fluid; SvO2; Mobilisation; Orthostatic function
A Study of RBT-9 in Healthy Volunteers and Subjects With Stage 3-4 Chronic Kidney Disease
Condition: Acute Kidney Injury
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Acute Kidney Injury
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1b, single-center, dose-escalating study to evaluate the safety,
      tolerability, pharmacokinetics, and pharmacodynamic effect of RBT-9 in healthy volunteers and
      in subjects with Stage 3-4 CKD.
    


Intervention name(s): RBT-9
Intervention type(s): Drug
Intervention description(s): intravenous administration
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Prevention
A Study of Minirin Melt in Japanese Patients With Central Diabetes Insipidus (CDI).
Condition: Central Diabetes Insipidus
MeSH terms: Diabetes Insipidus; Diabetes Insipidus, Neurogenic
Study type: Interventional
Phase: Phase 3

Summary: 
      This is an open-label dose-titration study in Japanese Central Diabetes Insipidus (CDI)
      patients designed to demonstrate the efficacy and safety of orally-disintegrating tablet of
      desmopressin.
    


Intervention name(s): Desmopressin Oral Melt; Desmopressin intranasal
Intervention type(s): Drug; Drug
Intervention description(s): Oral melt formulation starts on Day 2. The target initial dose of the orally disintegrating tablet is 180µg/day (60µg taken 3 times a day) and adjusted to optimally stabilise the participant's condition.; Self-administered intranasal desmopressin throughout the pre-study observation period (Days -30 to Day 0) and on study Day 1
Other intervention name(s): Minirin; FE992026
Intervention MeSH terms: Deamino Arginine Vasopressin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes
Force Sensing Resistor for Obstructive Sleep Apnea Patients After Tongue Base Reduction Surgery
Condition: Sleep Apnea, Obstructive
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      Obstructive sleep apnea syndrome (OSA) is a sleep-related breathing disorder defined by
      repetitive episodes of apnea and hypopnea. These traits include anatomical
      (narrow/crowded/collapsible upper airway) and nonanatomical (waking up too easily during
      airway narrowing [a low respiratory arousal threshold], ineffective or reduced pharyngeal
      dilator muscle activity during sleep, and unstable ventilatory control [high loop gain])
      components. Oropharyngeal training reduces the snoring times, Apnea-hypopnea Index (AHI) and
      daytime sleepiness. There is lack of good evaluating tools to distinguish different
      phenotypes of OSA and the efficacy of combined therapy. The purposes of our study are (1) to
      evaluate OSA patient by using Polysomonogrphy (PSG), force sensing resistor (FRS), Drug
      induce sleep endoscopy (DISE) and CT and muscle strength testing, (2) to know the exercise
      times by using FSR and (3) the efficacy of exercise in different groups.
    

Detailed description: 
      Subjects who are newly diagnosed with mild to severe OSA (AHI >5/h), and the physician will
      explain the treatment programs to every subject. By the result of muscle strength testing,
      the subjects will be classified as low muscle strength and normal groups. The myofunctional
      therapy program will begin at 6 week after surgery, and subjects will undergo 12 weeks of the
      home-based oropharyngeal myofunctional therapeutic training. During the training intervention
      period, subjects will be interviewed one time per week for adjusting the treatment intensity.

      Expected results：The hypothesis of this study is the efficacy of exercise would be less in
      the low muscle strength OSA patient than normal.
    

Intervention name(s): Tongue base reduction surgery
Intervention type(s): Procedure
Intervention description(s): Tongue base reduction surgery which remove the extra soft tissue of the base of the tongue and soft palate in this study
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Covert-saccades, Dynamic Visual Acuity and Quality of Life
Condition: Vestibular Diseases
MeSH terms: Vestibular Diseases
Study type: Interventional

Summary: 
      Patients with chronic bilateral vestibular hypofunction may suffer from a visual instability
      during head movement called oscillopsia. Visual consequence of vestibular deficit can lead to
      a severe impairment of their quality of life. However, correcting saccades during rapid head
      movement, called covert-saccades, have been more recently identified. These saccades, which
      occur during the head movement in patients with vestibular hypofunction, present a very short
      latency. They could compensate for the lack of vestibular-ocular reflex and greatly decrease
      oscillopsia and visual impairment. The objective of this study is to evaluate the potential
      functional benefice of these compensatory movements in a population of 20 patients with
      chronic bilateral areflexia, in a cross-sectional study.
    


Intervention name(s): Head Impulse Tests; Dynamic visual acuity Test (DVAT); VEMPs & VEMPo; Dizziness Handicap Inventory; Oscillopsia severity questionnaire
Intervention type(s): Other; Other; Other; Other; Other
Intervention description(s): Head Impulse Tests are performed by the clinician who holds the patient's head in his hands, while he is looking straight at an earth-fixed target; then by turning the patient's head abruptly and unpredictably to the left or right, up or down through a small angle (only 10-20 degrees - not a large angle). 20 impulses in each directions (6) will be performed.; Dynamic visual acuity Test (DVAT) assesses visual acuity during head movement relative to baseline static visual acuity. DVA will be assessed actively during self-generated rotations of the head in different directions.; VEMPs & VEMPo are sound evoked muscular contractions of the neck or eye. They are recorded using an evoked response computer, a sound generator, and surface electrodes to pick up neck or eye muscle activation.; Dizziness Handicap Inventory is a questionnaire that identify difficulties that patient may be experiencing because of dizziness, yielding to a score ranging from 0 to 100; Oscillopsia severity questionnaire is a 9 items questionnaires that identify oscillopsia in different circumstances.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Bilateral vestibular hypofunction; Video Head Impulse Test; Covert-saccades; Quality of life; Dynamic visual acuity
Does Complement Factor H Gene Polymorphism Play a Role in the Regulation of Vascular Tone in the Choroid?
Condition: Genetic Polymorphism; Macular Degeneration; Regional Blood Flow; Ocular Physiology
MeSH terms: Macular Degeneration
Study type: Interventional

Summary: 
      Age related macular degeneration (AMD) is a multifactorial disease with a strong genetic
      component. Most importantly a genetic polymorphism in the gene encoding for the complement
      factor H (CFH) has been recently identified which is highly associated with an increased risk
      of developing AMD. This Tyr402His polymorphism located on chromosome 1q31 has been implicated
      to play a role in the development of the disease.

      Given that it is known that impaired regulation of choroidal vascular tone is present in
      patients with AMD, the current study seeks to investigate whether the Tyr402His polymorphism
      is associated with altered choroidal autoregulation in healthy subjects. For this purpose a
      total of 100 healthy volunteers will be included in order to test the hypothesis that an
      impaired regulation of choroidal blood flow is present in subjects with homozygous Tyr402His
      variant.
    


Intervention name(s): Squatting
Intervention type(s): Procedure
Intervention description(s): Squatting for 6 minutes
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Age-related macular degeneration; Complement factor H; Choroidal blood flow
Effect of Vestibular Stimulation on Motor Proficiency and Balance Among Children With Down Syndrome
Condition: Vestibular System Disorder
MeSH terms: Vestibular Diseases; Down Syndrome
Study type: Interventional

Summary: 
      This was a randomized controlled trial study where there the total participants were 22and
      these participants were randomly selected and then distributed in to two groups all
      participants were selected according to the inclusion exclusion criteria of the study and
      then they were randomly distributed in two groups named as group A and group B both of the
      contain equal number of participants which are randomly distributed in groups each group
      contain 11 participants .Group A received the vestibular stimulation by swing in different
      positions supine, prone and with or without support in each position for 10minnts 3 times a
      week for 10 weeks along with general strengthening exercises of upper and lower limb and
      group B will receive general strengthening exercises of whole body for same time period. Data
      will be then analyzed by using SPSS windows version 25
    

Detailed description: 
      This was a randomized controlled trial study where there the total participants were 22and
      these participants were randomly selected and then distributed in to two groups all
      participants were selected according to the inclusion exclusion criteria of the study and
      then they were randomly distributed in two groups named as group A and group B both of the
      contain equal number of participants which are randomly distributed in groups each group
      contain 11 participants .Group A received the vestibular stimulation by swing in different
      positions supine, prone and with or without support in each position for 10minnts 3 times a
      week for 10 weeks along with general strengthening exercises of upper and lower limb and
      group B will receive general strengthening exercises of whole body for same time period.
    

Intervention name(s): Vestibular stimulation; General strengthening exercises
Intervention type(s): Other; Other
Intervention description(s): Vestibular stimulation by swing; General strengthening exercises
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Vestibular stimulation (VeS); Hypotonic cerebral palsy