bioihbjkbjnl/mcl2 huggingface dataset:
Genotype-guided Versus Standard for Warfarin Dosing
Condition: Atrial Fibrillation; Valvular Heart Disease
MeSH terms: Atrial Fibrillation; Heart Diseases; Heart Valve Diseases
Study type: Interventional

Summary: 
      To compare the efficiency and safety between gene-oriented group and standard care group
      during 90 days of initial warfarin-treatment for requiring anticoagulation patients with
      valve replacement or atrial fibrillation with or without valvular heart disease。
    

Detailed description: 
      Due to narrow therapeutic window, and individual differences in dosage, inappropriate use of
      warfarin may lead to serious complications and ineffective. Based on the results of the
      research on the transformation of warfarin pharmacogenomics, this study investigates the
      clinical application of gene-directed warfarin dose prediction model through the preset
      dosage regimen of warfarin during the initial treatment phase. Compared with the conventional
      treatment, that is to say empirical medication, this study is to verify the feasibility and
      value of gene-oriented warfarin dose prediction model, in order to establish a practical
      guidance to optimize the rational use of warfarin treatment program, to enable patients to
      obtain effective, safe warfarin dose, and to achieve the established anticoagulant strength
      faster and safer, as the same time, to reduce the times of patients was blood and the
      incidence of bleeding/embolism, and to save costs and ensure the safety of warfarin clinical
      medication.
    

Intervention name(s): Gene-directed dosage of warfarin; standard dosage of warfarin
Intervention type(s): Other; Other
Intervention description(s): the first day given model prediction dose * 1.5 times（<6mg）；the second day given model prediction dose；adjusted dose based on INR from the third day; the first day given 4.5mg; adjusted dose based on INR from the second day
Intervention MeSH terms: Warfarin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: warfarin; gene
Uterocervical Angle in the Termination of Second Trimester Pregnancy
Condition: Abortion, Second Trimester
Study type: Observational [Patient Registry]

Summary: 
      To evaluate the performance of uterocervical angle (UCA) in the prediction of second
      trimester terminations.
    

Detailed description: 
      Medical termination of pregnancy is a common procedure in obstetrics. In recent years,
      uterocervical angle (UCA) emerged as a new ultrasound parameter in the prediction of labor.
      Dziadosz et al concluded that the performance of UCA was even better than the cervical length
      in their cohort. A wide UCA during second trimester shown to have an increased risk of
      preterm labor and narrow angle was less likely to have labor.

      The investigators are aimed to investigate predictive role of both cervical length and UCA in
      the termination of second trimester pregnancy.The investigators focused on nulliparous women
      who are taking misoprostol for the cervical preparation and aim to measure their UCA.
    

Intervention name(s): uterocervical angle
Intervention type(s): Other
Intervention description(s): uterocervical angle is the angle between lower segment of uterus and cervix
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pregnant population undergoing medical induced second trimester abortion.
      
Keywords: uterocervical angle, second trimester abortion
Effect of Moisturising Creams on Skin Moisture in Atopic Dermatitis
Condition: Dermatitis, Atopic
MeSH terms: Dermatitis, Atopic; Dermatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study is evaluate the effect of three moisturising creams on Stratum corneum
      (SC) hydratation and barrier function.
    

Detailed description: 
      In the present study, 24 subjects with AD will be treated for 3 weeks twice daily by using 3
      different moisturising creams. Duration of the study is based on literature. Various
      moisturising creams containing glycerol have been reported to be beneficial for AD lesions.
      The optimal glycerol content in moisturising creams is not known. The secondary objective is
      the comparison of change in the SC water content and in the TEWL from the skin surface from
      the baseline to the end of study between different moisturizing creams containing different
      amount of glycerol.

      Change in the SC water content and in the TEWL can be demonstrated with noninvasive
      instrumental measurement. The treated skin will be followed up instrumentally, and one
      measurement area will serve as an untreated control. The primary evaluation is the comparison
      of change in the SC water content and in the TEWL on the skin surface from the baseline to
      the end of study between the 4 treatments.
    

Intervention name(s): Aqualan L, Aqualan Plus, Aqualan L + glycerol ad 20%
Intervention type(s): Other
Intervention description(s): moisturising cream twice daily three weeks
Intervention MeSH terms: Glycerol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Dermatitis; Atopic; Moisturising cream; Skin
Functional Reserve Estimation of Donor Kidney
Condition: End-stage Renal Disease
MeSH terms: Kidney Failure, Chronic
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study:

        -  To estimate the role of morphological, clinical, biochemical and imaging studies at
           stages of kidney transplantation (medical therapy, explantation, preservation,
           transplantation).

        -  To improve the ways of preserving optimal functional parameters of renal transplants.
    

Detailed description: 
      Terminal chronic renal failure (ESRD) as a result of almost any chronic kidney disease
      develops due to progressive loss of nephrons. This state is characterized by a gradual
      deterioration of the functional abilities of not only the kidneys, but also the whole body.
      Currently, ESRD is among the first ten causes of mortality .

      Transplantation of donor organs is the only radical treatment for various diseases of the
      terminal, for patients with a fatal prognosis.

      Kidney transplantation has allowed not only save lives, but also to return to normal life,
      tens of thousands of people. Survival of renal transplant recipients is growing.

      Despite the progress made in many clinics worldwide in recent years in the field of
      transplantation, kidney transplantation, does not settle the problem of reperfusion injury
      and the associated post-transplant dysfunction with the absence of clear indicators of
      morphological, clinical, biochemical and instrumental methods to assess functional reserve of
      organs that remain relevant and meaningful.
    

Intervention name(s): Kidney Transplantation from alive relative donor
Intervention type(s): Procedure
Intervention description(s): Donor kidney sampling, preservation, transport and transplantation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Kidney transplantation,functional status,survival.
Safety and Pharmacokinetic Study of C13-URA in Healthy Volunteers
Condition: Gastroparesis
MeSH terms: Gastroparesis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and establish the pharmacokinetic (PK)
      profile of C13-URA in healthy volunteers
    

Detailed description: 
      The C13-URA Breath Test Kit is intended to be used as a diagnostic tool to identify rapid
      and/or delayed gastric emptying in patients who have upper GI symptoms such as stomach pain,
      fullness, early satiety, vomiting, etc., and who have suspected gastric emptying
      abnormalities such as gastroparesis or dumping syndrome.

      This study will be a double-blind, placebo-controlled, 3-period safety and PK study of
      13C-uracil administered as a single oral dose of 50 mg at step 1 (Period 1), 100 mg at step 2
      (Period 2), and 200 mg at step 3 (Period 3) in the form of a semi-solid meal to subjects
      following at least a 10-hour fast from food and 2-hour fast from water. Dosing will be
      followed by a 6-hour fast from food and a 4-hour fast from water. There will be a washout of
      at least 7 days between doses.

      The objectives of this study are as follows;

      1)to evaluate the safety of 13C-uracil in a semi-solid meal in healthy volunteers, 2)to
      establish the pharmacokinetic profile of 13C-uracil in a semi-solid meal in healthy
      volunteers, 3)to assess the correlation between plasma concentration of 13C-uracil and
      urinary excretion of 13C-uracil, 4)to evaluate the reproducibility (intra/inter-individual
      variance) of the breath test, 5)to determine the dose for 13C-uracil that facilitates
      adequate Δ13C in breath expired by healthy volunteers
    

Intervention name(s): [2-13C] uracil; [2-13C] uracil, placebo
Intervention type(s): Drug; Drug
Intervention description(s): po, in the form of semi-solid meal, granules, once a period; po, in the form of semi-solid meal, granules, once a period
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Diagnostic
A Study of LY3471851 in Participants With Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to learn more about the safety and side effects of
      LY3471851 when given by injection just under the skin to participants with psoriasis. The
      study will last up to 48 weeks and may include up to 23 visits to the study center.
    


Intervention name(s): LY3471851; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered SC; Administered SC
Other intervention name(s): NKTR-358
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Sodium Lactate Infusion in GLUT1DS Patients
Condition: GLUT1 Deficiency Syndrome; GLUT1DS1; GLUT1DS2; Epilepsy; Lactic Acid Blood Increased; Ketogenic Dieting
MeSH terms: Epilepsy; Hyperlactatemia; Syndrome
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This study investigates the effect of lactate infusion on epileptic discharges on EEG and
      seizure frequency in glucose transporter 1 deficiency syndrome (GLUT1DS) patients.
    

Detailed description: 
      In glucose transporter 1 deficiency syndrome (GLUT1DS) cerebral glucose uptake from the
      systemic blood circulation is limited, because of deficient transport of glucose across the
      blood-brain barrier by the transporter protein (GLUT1). Classically patients present with
      developmental problems, movement disorders and severe epilepsy. There is no curative
      treatment for GLUT1DS, and anti-epileptic drugs usually have little to no effect. The
      ketogenic diet, providing ketones as an alternative energy substrate for the brain is an
      effective treatment option for the epilepsy and movement disorders in many GLUT1DS patients.
      Unfortunately, not in all GLUT1DS patients the ketogenic diet has a positive effect and other
      treatment options for these patients are very limited.

      Traditionally, lactate is seen as a waste product of glycolysis during anaerobic conditions
      and a marker of ischemia. Interestingly, research has shown the beneficial side of lactate as
      an energy source for different organs. It seems that the brain can indeed use lactate as an
      alternative energy metabolite, besides glucose and ketones. The aim of this study is to
      investigate whether lactate can be an alternative energy metabolite in the GLUT1DS brain, and
      reduce epileptic discharges on EEG when intravenously administered in patients with GLUT1DS.
    

Intervention name(s): sodiumlactate
Intervention type(s): Other
Intervention description(s): intravenous sodiumlactate 600mmol/L
Intervention model: Single Group Assignment
Intervention model description: Single center, interventional, explorative, open label, proof of principle study
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: GLUT1 deficiency syndrome; sodium lactate infusion; epilepsy
Clinical Study Assessing a New Scale to Measure Onset of Action in Generalized Anxiety Disorder
Condition: Anxiety Disorders
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      The study is to assess the performance characteristics of a new measure to assess onset of
      efficacy in a GAD patient population.
    


Intervention name(s): lorazepam; placebo; paroxetine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 1.0 mg p.o. three times a day for three days, then 1.5mg p.o. three times a day for 25 days; placebo p.o. t.i.d. for 28 days; placebo matching lorazepam and paroxetine; 20mg p.o. daily for 28 days; and matching placebo twice a day to maintain blind
Other intervention name(s): Ativan; Paxil
Intervention MeSH terms: Lorazepam; Paroxetine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: generalized anxiety disorder; onset of efficacy; Daily Assessment of Symptoms-Anxiety (DAS-A); Methods
Evaluation of Human Zinc Absorption From Wheat-based Meals
Condition: Zinc Deficiency
Study type: Interventional

Summary: 
      Study part 1 and 2 Assessment of Zn absorption from regular and biofortified wheat: stable
      isotope absorption studies in women of childbearing age consuming test meals prepared from
      either the biofortified Zn wheat, regular wheat or post-harvest fortified wheat at two
      different extraction rates.

      Study part 3 Assessment of Zn absorption from intrinsically and extrinsically labeled wheat:
      stable isotope absorption studies in women of childbearing age, or men, consuming test meals
      prepared from either intrinsically labeled Zn biofortified wheat, regular wheat or
      post-harvest fortified wheat extrinsically labeled immediately before consumption.
    

Detailed description: 
      The overall goal of study part 1 and 2 is to evaluate and compare the fractional and absolute
      Zn absorption from biofortified wheat cultivar (60 ppm Zn) to regular wheat (28 ppm Zn) and
      to post harvest fortified wheat (60 ppm Zn) for a total of 3 test meals per study. The
      studies will be conducted with products based on wheat with high extraction rate (study part
      1) and medium extraction rate (study part 2) in two separate groups of women of childbearing
      age.

      The goal of study part 3 is to investigate the difference of absorption measurements between
      intrinsically and extrinsically labeled biofortified wheat. The label of the test meals will
      have the same nature as the fortificant itself (extrinsic vs intrinsic), for a total of 3
      test meals.
    

Intervention name(s): Biofortified wheat; Fortified wheat; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Extrinsic label 67Zn (ZnSO4) 0.2mg 70Zn added to the IV dose; Extrinsic label 67Zn (ZnSO4) 0.2mg 70Zn added to the IV dose
Other intervention name(s): Esperia
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Zinc
Fibersol-2 Clinical Trials Related to Appetite
Condition: Lack of Satiety
Study type: Interventional

Summary: 
      Emerging research suggests fiber, particularly digestion-resistant maltodextrins such as
      Fibersol-2, may impact satiety, by decreasing hunger, prolonging satiation, and/or increasing
      satiety signals from the gut. This research aims to determine whether or not Fibersol-2 may
      impact satiety, by decreasing hunger, prolonging satiation, and/or increasing satiety signals
      from the gut.
    


Intervention name(s): placebo; digestion-resistant maltodextrin
Intervention type(s): Other; Dietary Supplement
Other intervention name(s): Fibersol-2
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: dietary fiber; satiety response; hunger; CCK; PYY; ghrelin; GIP; GLP-1
Self-help Treatment for Insomnia in Breast Cancer Patients
Condition: Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional

Summary: 
      The main goal of this population-based study is to assess the efficacy of two forms of
      cognitive-behavioral therapy (CBT) to treat various levels of insomnia symptoms in women with
      breast cancer: a professionally administered form and a patient self-administered form. It is
      hypothesized that the two treatment conditions will be associated with significantly greater
      improvements in sleep, psychological distress, fatigue, cognitive functioning, and quality of
      life, relative to the control condition (i.e., usual care). It is also hypothesized that the
      magnitude of effect sizes obtained in association with treatment at each time assessment will
      be greater for the professionally administered treatment than the self-administered
      treatment.
    


Intervention name(s): professionally administered cognitive-behavioral therapy; self-administered form of cognitive-behavioral therapy; placebo
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): professionally administered CBT-I consisting of six weekly sessions; self-administered CBT-I consisting of six short booklets and videotapes; usual care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluate the Safety and Efficacy of a 5-HT4 Agonist in Chronic Constipation (ACCORD Trial)
Condition: Chronic Constipation
MeSH terms: Constipation
Study type: Interventional
Phase: Phase 2

Summary: 
      Study 0038 compares the safety and effectiveness of an investigational drug, TD-5108 with
      placebo (a sugar pill) for the treatment of chronic constipation.
    


Intervention name(s): TD-5108
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: constipation; chronic; bowel function
Motor Cortex as a Research & Therapeutic Target in TMD
Condition: Temporomandibular Joint Disorders
MeSH terms: Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome
Study type: Interventional

Summary: 
      The investigators are doing a study to learn about the effects of a type of low-energy
      non-surgical electrical brain stimulation (HD-tDCS) on chronic pain in people's jaw joints.
      Disorders in these joints are called temporomandibular joint disorders, or TMD.
    

Detailed description: 
      Chronic temporomandibular joint disorders (TMD) represent clinical problems in which
      empirical treatments offer uncertain relief for a large number of patients. Many conventional
      therapies are ineffectual, leading to persistent treatment failure and/or poor
      iatrogenic-induced results; which raises the possibility that the cause for their pain
      endurance may also lie in the brain milieu. Although MRI-based techniques have provided
      insights into some neuroplastic mechanisms of TMD in humans, many questions regarding its
      molecular mechanisms in vivo are still unanswered. First, how are endogenous μ-opioid
      mechanisms in the brain, known to be centrally involved in pain regulation, affected by acute
      and chronic TMD pain? Second, how can they be directly modulated to provide analgesic effect
      on pain measures? Finally, what are the neuroplastic effects in the brain after continuous
      modulation of those molecular mechanisms? The understanding of these processes is crucial to
      determine the mechanisms engaged in the persistence and, most important, the alleviation of
      TMD.

      Preliminary studies from our center, using positron emission tomography (PET) with [11C]
      carfentanil, a selective radiotracer for mu-opioid receptor (muOR), have demonstrated that
      there is a decrease in μOR availability (non-displaceable binding potential -BPND) in key
      pain-related structures in the brains of chronic trigeminal pain patients, which correlated
      with their clinical pain measures. We propose to demonstrate that acute (masseteric pain
      challenge) and chronic clinical pain measures in TMD patients are correlated with μ-opioid
      receptor (µOR) non-displaceable binding potential (BPND) in the thalamus and other
      pain-related regions.
    

Intervention name(s): High-Definition Transcranial Direct Current Stimulation (HD-tDCS)
Intervention type(s): Device
Intervention description(s): HD-tDCS is a non-invasive brain neuromodulatory method for M1 that involves sending a weak electrical current into your brain.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment