bioihbjkbjnl/mcl2 huggingface dataset:
Relation Between Maternal Iodine Status and Prenatal Foetal Thyroid Dimension
Condition: Deficiency Disease
MeSH terms: Deficiency Diseases
Study type: Interventional

Summary: 
      Mother with severe Iodine deficiency are more likely to have neonates with further poor
      mental development . In order to select population which could benefit from iodine
      supplementation, ioduria has been tested but cannot be routinely practised. Strong background
      data suggest that iodine status could be antenatally correlated with foetal thyroid volume.
      The aim of that study is to examine correlation between these two parameter in a population
      of 130 healthy pregnant women.
    

Detailed description: 
      Iodine is an essential element in thyroid homeostasis, particularly in pregnant woman and her
      fetus. Various studies have clearly shown that antenatal thyroid disorders at both the mother
      and the fetus could cause in extreme situations of neurological consequences.

      At a broader scale, subtle alterations of thyroid hormone balance has been implicated in
      developmental delays and deviations of the IQ bell curve in newborn infants of mothers with
      elevated TSH.

      The clinical implications of these basic data and public health are yet to confirm.

      It has been clearly established that there is a moderate iodine deficiency in France with a
      decreasing gradient from west to east. In the Ile de France, there is a moderate iodine
      deficiency, this has led some teams to propose a systematic supplementation of all women in
      iodine.

      One way to target women who really need supplements systematic determination of urinary
      iodine tongue; this assay is reliable but is difficult to implement in an ad hoc practice at
      the individual level.

      Our team has expertise in the field of fetal thyroid, particularly in its sonographic and
      reference curves of the perimeter and diameter of the thyroid are now clearly established
      reliably.

      Knowing that iodine deficiency is causing a decline in maternal urine iodine with a
      phenomenon goitrigénèse and biological hypothyroidism and that some studies have shown that
      neonatal thyroid volumes were higher in iodine deficient mothers . We postulate that the
      measurement of fetal thyroid by our criteria can be correlated with maternal urinary iodine.

      If this were the case, we will have a simple test to identify iodine supplementation in
      pregnant women.
    

Intervention name(s): echography
Intervention type(s): Other
Intervention description(s): Correlation of neonatal thyroid volume with maternal iodine deficiency
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: foetal thyroid mensuration
CBART: The Reduction of Psychological and Physiological Stress in Women Undergoing IVF
Condition: Psychological Stress; DNA Degradation, Apoptotic; Telomere Shortening; Fertility Disorders
MeSH terms: Stress, Psychological
Study type: Interventional

Summary: 
      The study is a randomized controlled trial of a cognitive behavioral interventions and an
      art-based stress reduction treatment protocol (CB-ART) with 100 women, identified with
      elevated perceived stress, before undergoing IVF treatment; in order to examine its effect on
      perceived stress, plasma CFD, telomere length and pregnancy rates.

      CB-ART is a 6-session treatment protocol that has been utilized with women coping with
      stress, depression and pain and is effective in reducing these indicators, developed and
      evaluated by our research team. The treatment protocol emphasizes processing together with
      the client's recalled image, symptom or memory (ISM) pertaining to a current distressing
      mental or physical state. CB-ART is a multi-method model that integrates cognitive behavioral
      interventions and art-based stress reduction interventions. The innovation in this method is
      the transformation of imagined and drawn images and memories rather than solely verbally
      discussing their contents. The focus is on changing compositional elements that comprise each
      image and memory, thus providing a therapeutic venue to reframe and transform stress
      producing, recalled images and memories and reduce symptoms of perceived stress. Art making
      is beneficial for eliciting an emotional response and provides a concrete platform to conduct
      the cognitive processing that initiate change on the paper and then in the mind. Furthermore,
      the soothing qualities of interacting with art making foster and enhance behavioral
      relaxation techniques.

      Our study population, women with infertility problems, who are designated to undergo IVF
      treatment and have been identified to have elevated perceived stress scores on the Perceived
      Stress Scale (above 15) will be randomized and allocated to receive the CB-ART intervention
      tailored to reduce stress or treatment as usual.
    


Intervention name(s): CBART
Intervention type(s): Behavioral
Intervention description(s): Cognitive Behavioral protocol that uses art-making for stress reduction and cognitive interventions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
The Effect of Liposome Vitamin C on the Absorption and Metabolism of the Human Body.
Condition: Vitamin C Deficiency
MeSH terms: Scurvy; Ascorbic Acid Deficiency
Study type: Interventional

Summary: 
      To evaluate the difference between vitamin C in the form of oral liposomes and general
      vitamin C in a fixed period of time in plasma and urine.
    

Detailed description: 
      we recruited 11 healthy subjects and adopted a cross-over test. the subjects need to take 3
      tests during trail. After each test was completed, a washout period of 14 days was required
      before the next test start. The subjects were informed to consume one sachet vitamin C
      without liposome, liposomal process A vitamin C, or liposomal process B vitamin C (Double
      Nutri™) every test, and vitamin C concentration was measured at baseline (0 hours), 0.5, 1,
      2, 3, 4, and 8 hours after taking test sample.
    

Intervention name(s): vitamin C without liposome; liposomal process A vitamin C; liposomal process B vitamin C (Double Nutri™)
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): subjects need to take 3 tests during trail. After each test was completed, a washout period of 14 days was required before the next test start; subjects need to take 3 tests during trail. After each test was completed, a washout period of 14 days was required before the next test start; subjects need to take 3 tests during trail. After each test was completed, a washout period of 14 days was required before the next test start
Intervention MeSH terms: Vitamins; Ascorbic Acid; Vitamin B Complex
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Investigating Safety, Tolerability and Pharmakinetics When Giving Single and Fractionated Doses of AZD3241 to Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is carried out in order to investigate safety, tolerability and pharmacokinetics
      after administrating single and fractionated doses of AZD3241 to healthy volunteers
    


Intervention name(s): AZD3241; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): single oral dose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Single dose; Phase 1; Safety of AZD3241; tolerability of AZD3241
Minimum Effective Volume of Ropivacaine 7.5 mg/ml for the Lateral and Sagittal Infraclavicular Brachial Plexus Block
Condition: Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      Systemic LA toxicity is an important complication of regional anesthesia. Lowering the LA
      dose is one of the strategies to reduce this risk. For upper limb blocks it is well
      documented that ultrasound guidance allows a significant lower dose of LA for interscalene
      and axillary blocks than with guidance by peripheral nerve stimulation. However, a
      corresponding difference has not yet been found for supraclavicular and infraclavicular
      blocks. The aim of the present study is to define the minimum effective volume of ropivacaine
      7.5 mg/ml when using the LSIB method.
    

Detailed description: 
      The blocks will be performed as previously described, by an anesthesiologist with LSIB
      expertise. The lateral, medial and posterior cords are the target of infra-clavicular
      brachial plexus blocks. During a prescan we will record if they can be visualized by
      ultrasound and indicate their positions periarterially. The deep location of the cords may
      hamper their identification, especially that of the medial cord. We describe the cord
      positions with reference to the short-axis (cross-sectional) view of the axillary artery,
      which is compared to a clockface having 12 o'clock ventrally. In a former MRI study it was
      found that the cords were usually located in a sector from 3-11 o'clock (the 3-11 sector) and
      within a distance of 2 cm from the midaxis of the axillary artery. The point closest to the
      cords was at 8 o'clock, immediately outside the arterial wall. Point of needle insertion is
      at the intersection between the lower edge of the clavicle and the medial surface of the
      coracoid process. We direct the needle tip to the 8 o'clock position and observe the spread
      of LA from this position. On demand we adjust the needle position to secure a complete fill
      of the 3-11 sector with LA (multiple injections).

      The block needle has an electrical cable. Prior to LA injections we test if a minimal
      electric output (0.2 mA/0.1 msec duration) elicits a motor response. If such a response is
      obtained, the needle is withdrawn (in steps of 1 mm), until the motor response disappears.
      This is to reduce the risk of intraneural injection.
    

Intervention name(s): Ropivacaine
Intervention type(s): Drug
Intervention description(s): Dosage. Onset time
Other intervention name(s): Naropin
Intervention MeSH terms: Ropivacaine
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ropivacaine; Brachial plexus
Ibodutant for Relief of Irritable Bowel Syndrome With Diarrhoea (IBS-D)
Condition: Irritable Bowel Syndrome With Diarrhea
MeSH terms: Irritable Bowel Syndrome; Syndrome; Diarrhea
Study type: Interventional
Phase: Phase 2

Summary: 
      Irritable Bowel Syndrome with diarrhoea (IBS-D) is a functional gastrointestinal disorder
      characterised by chronic or recurrent abdominal pain or discomfort and diarrhoea. This trial
      aims at the evaluation of the efficacy and safety of the neurokinin type 2 receptor
      antagonist Ibodutant in improving IBS-D symptoms.
    

Detailed description: 
      The study evaluates the efficacy and safety of three doses of ibodutant, given once daily for
      8 weeks versus placebo in IBS-D patients. Efficacy is evaluated in terms of overall symptom
      relief and abdominal pain/discomfort relief after 8 weeks of treatment. The clinical phase of
      the study comprises a 2-week run-in period (treatment-free),an 8-week double-blind treatment
      period and a 2-week treatment withdrawal period, resulting in a 10-week overall duration of
      the study for each patient.

      Patients report their IBS-related symptoms daily in an electronic diary (web-and telephone
      based)during all periods of the study.
    

Intervention name(s): Ibodutant; Ibodutant; Ibodutant; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Oral tablet, low dose, once daily, for 8 weeks; Oral tablet, intermediate dose, once daily, for 8 weeks; Oral tablet, high dose, once daily, for 8 weeks; Oral tablet, (identical in appearance and weight to Ibodutant tablets), once daily, for 8 weeks
Other intervention name(s): Code: MEN 15596; Code: MEN 15596; Code: MEN 15569; Sugar pill
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Irritable Bowel Syndrome; Colon, irritable; Bowel disease
Assessment of Bioavailability of Phenolics From an Orange Peel Extract
Condition: Improving Bioavailability
Study type: Interventional

Summary: 
      In this study, the bioavailability of a specific orange peel extract is tested. The
      composition and morphology of the test product is altered compared to the generic product,
      which is used as a control. Due to intellectual property issues, more information cannot be
      given at this moment. Also the difference in bioavailability between a capsule and a lozenge
      is tested. The hypothesis is that the bioavailability of the altered extract will be improved
      compared to the control.
    


Intervention name(s): phenolics form orange peel
Intervention type(s): Dietary Supplement
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: phenolics; orange peel; bioavailability
Posterior Capsule Opacification Study
Condition: Cataract
MeSH terms: Cataract; Capsule Opacification
Study type: Interventional
Phase: Phase 4

Summary: 
      First object is to compare square edge PMMA with round edge PMMA IOL where the materials are
      same. Next objective is to compare square edge PMMA IOL with Acrysof IOL where the materials
      are different
    

Detailed description: 
      Cataract is the vision impairing disease characterized by gradual, progressive thickening of
      the lens. Posterior Capsular Opacification (PCO) remains the most frequent long term
      complication. This is initiated by the migration and proliferation of residual lens
      epithelial cells from the lens equator in the space between the posterior capsule and
      intraocular lens (IOL)

      The combination of IOL material and a sharp edged design is effective in preventing PCO.
      Aurolab has developed 360 degree square edge IOL with polymethyl methacrylate (PMMA)

      100 bilateral senile cataract patients are going to be recruited. First group of 50 patients
      will receive square edge PMMA in one eye and round edge PMMA in fellow eye. Another group of
      50 patients will receive square edge PMMA in one eye and acrysof in fellow eye. PCO will be
      assessed during each follow up using EPCO software.
    

Intervention name(s): Square edge PMMA IOL; Round edge PMMA IOL; Acrysof IOL; square Edge PMMA IOL; Square Edge PMMA IOL
Intervention type(s): Device; Device; Device; Device; Device
Intervention description(s): Arm 1 A - Square edge PMMA IOL; Round edge PMMA IOL; Acrysof IOL; Square edge PMMA intra ocular lens; Square Edge PMMA IOL lens
Other intervention name(s): TrueEdge IOL; S3602SQ; S3602; SA60AT
Intervention MeSH terms: Polymethyl Methacrylate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Double-Blind Method; Clinical Trials, Randomized; Lenses, Intraocular; Prospective Studies; PMMA; Visual acuity
Yoga Breath Program and Client-Centered Exposure for Relief of PTSD in Tsunami Victims
Condition: Posttraumatic Stress Disorder; Depression
MeSH terms: Depression; Depressive Disorder; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 3

Summary: 
      Study hypothesis: that a standardized course of Eastern practices (Breath Water Sound Course
      -BWS) will significantly relieve PTSD and depression in tsunami victims. Further, that a
      client-centered exposure treatment (Traumatic Incident Reduction- TIR) would provide
      additional, significant relief of PTSD and depression in tsunami victims.

      180 tsunami victims in Southern India will be divided into three groups: those that only
      receive BWS course, those that receive the BWS course and TIR and a wait-list control. They
      will be pretested with the PCL-17 (PTSD scale), the Beck Depression Inventory and the General
      Health Questionaire. These scales will also be administered post-service as well as five
      weeks post pre-testing and at three and six month intervals.
    


Intervention name(s): Breath Water Sound Course and Traumatic Incident Reduction
Intervention type(s): Behavioral
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Posttraumatic stress disorder; depression; disaster mental health; yoga; Breathwork; exposure treatments
Selonsertib in Adults With Pulmonary Arterial Hypertension
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to evaluate the effect of selonsertib (GS-4997) on
      pulmonary vascular resistance (PVR), as measured by right heart catheterization (RHC) in
      adults with pulmonary arterial hypertension (PAH). The study will consist of a 24-week
      placebo-controlled treatment period and a long-term selonsertib treatment period.
      Participants completing the 24-week placebo-controlled period will be eligible to receive
      active treatment with selonsertib in the long-term treatment period.
    


Intervention name(s): Placebo; Selonsertib
Intervention type(s): Drug; Drug
Intervention description(s): Tablet administered orally once daily; Tablets administered orally once daily
Other intervention name(s): GS-4997; GS-4997
Intervention MeSH terms: Selonsertib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Everolimus in Combination With DHAP in Patients With Relapsed or Refractory Hodgkin Lymphoma
Condition: Hodgkin Lymphoma
MeSH terms: Lymphoma; Hodgkin Disease
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this trial is

        1. to determine the recommended dose of everolimus for a subsequent Phase II trial

        2. to determine the efficacy of everolimus plus DHAP
    


Intervention name(s): DHAP; Everolimus
Intervention type(s): Drug; Drug
Intervention description(s): Dexamethasone, Cytarabine, Cisplatin
Intervention MeSH terms: Everolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Safety and Tolerability of BL-1020 in Hospitalized Subjects With Chronic Schizophrenia or Schizo-Affective Disorder
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders; Mood Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      An open-label, multi-center, 6-week, sequential cohort study designed to determine the safety
      and tolerability of two dose ranges of BL-1020 in hospitalized subjects with chronic
      schizophrenia or schizo-affective disorder
    


Intervention name(s): BL-1020; BL 1020 High Dose
Intervention type(s): Drug; Drug
Intervention description(s): BL-1020 Low Dose; BL 1020 High Dose
Intervention MeSH terms: Perphenazine; gamma-Aminobutyric Acid
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: chronic schizophrenia or schizo-affective disorder
Combination of Fimasartan/Amlodipine/Hydrochlorothiazide in Healthy Male Subjects
Condition: Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the Pharmacokinetics and safety/tolerability between
      Fimasartan/Amlodipine/Hydrochlorothiazide and co administration of Fimasartan/Amlodipine and
      Hydrochlorothiazide in Healthy volunteers.
    


Intervention name(s): Treatment T; Treatment R
Intervention type(s): Drug; Drug
Intervention description(s): Fixed dose Combination of Fimasartan/Amlodipine/Hydrochlorothiazide; Co-administration of Fimasartan/Amlodipine and Hydrochlorothiazide
Other intervention name(s): FAH; FA/H
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hypertension
Ciprofloxacin XR Drug Interaction Study With MMX® Mesalazine/Mesalamine
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a drug interaction study evaluating the pharmacokinetic profiles of Ciprofloxacin XR
      administered alone & in combination with MMX Mesalazine/mesalamine.
    


Intervention name(s): Ciprofloxacin XR + MMX Placebo; MMX Mesalazine/mesalamine + Ciprofloxacin XR
Intervention type(s): Drug; Drug
Intervention description(s): MMX Mesalazine/mesalamine placebo dosed once-a-day (QD) orally for 3 days, then a single oral 500 mg dose of ciprofloxacin XR + a single oral dose of MMX Mesalazine/mesalamine placebo on day 4; MMX Mesalazine/mesalamine 4.8 g QD orally for 3 days, then a single oral 500 mg dose of ciprofloxacin XR + a single oral dose 4.8 g of MMX Mesalazine/mesalamine on day 4
Other intervention name(s): Lialda
Intervention MeSH terms: Ciprofloxacin; Mesalamine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Multicenter Study to Evaluate the Efficacy and Safety of Metoclopramide Nasal Spray in Men With Diabetic Gastroparesis
Condition: Diabetic Gastroparesis
MeSH terms: Gastroparesis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is evaluate the safety and efficacy of Metoclopramide Nasal Spray
      compared to placebo in reducing the symptoms of diabetic gastroparesis in adult men.
    

Detailed description: 
      Diabetic men with clinical symptoms attributed to diabetic gastroparesis and documentation of
      delayed gastric emptying who meet the protocol-specified entry criteria will be randomized to
      Metoclopramide Nasal Spray 10 mg or placebo administered as a single intranasal spray four
      (4) times daily; 30 minutes before meals and at bedtime for a total of four (4) weeks.
    

Intervention name(s): Metoclopramide Nasal Spray; Placebo Nasal Spray
Intervention type(s): Drug; Drug
Intervention description(s): One 10 mg spray dose 30 minutes before meals and before bed for 28 days (QID); One placebo spray dose 30 minutes before meals and before bed for 28 days (QID)
Other intervention name(s): Vehicle
Intervention MeSH terms: Metoclopramide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Diabetes; Gastroparesis; Delayed gastric emptying; Nausea; Vomiting; Bloating; Abdominal pain; Early Satiety; Gastric stasis; Gastropathy