bioihbjkbjnl/mcl2 huggingface dataset:
Postprandial Response to Almond Consumption in Overweight Hispanic Pregnant Women
Condition: Diabetes, Gestational
MeSH terms: Diabetes, Gestational; Overweight
Study type: Interventional

Summary: 
      Currently, about one third of all women entering pregnancy are obese. The prevalence of
      metabolic disorders during pregnancy has increased concurrently with the rise in maternal
      obesity. Although dietary interventions are used routinely to reduce metabolic disease in
      non-pregnant obese individuals, no specific dietary advice is provided to obese, pregnant
      women unless they develop gestational diabetes mellitus. In this study, the investigators
      will specifically assess the effect of replacing dairy fats with almonds in a breakfast meal
      on the postprandial metabolic response. This cross-over, randomized control trial will
      examine the postprandial metabolic response to 0 or 2 oz of almonds in standardized test
      meals in pregnant Hispanic women with prepregnancy BMI between 25 and 40. Hispanics are at
      higher risk for gestational diabetes and the metabolic syndrome. The investigators
      hypothesize that consuming almonds in place of dairy fat reduces the glycemic response and
      improves the postprandial lipid profile in these high-risk women.
    


Intervention name(s): Bagel; Cream Cheese; Almond Butter
Intervention type(s): Other; Other; Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: Postprandial; Insulin resistance; Lipids; Satiety; Almonds
Vascular Abnormalities and Bleeding Diathesis
Condition: Bleeding Diathesis
MeSH terms: Hemostatic Disorders; Blood Coagulation Disorders; Hemorrhagic Disorders; Hemorrhage; Disease Susceptibility
Study type: Observational

Summary: 
      Inherited bleeding disorders (IBD) consist of a heterogeneous group of diseases including
      coagulation and/or platelets defects and more rarely vascular dysfunctions. A family of four
      patients suffering from unexplained excessive bleeding has been followed clinically in France
      for many years. Recently, whole exome sequencing (WES) of DNA allowed the identification of a
      heterozygous genetic variant which segregated to family members with bleeding diathesis. The
      aim of the study was to better characterize the phenotype by studying VWF and platelets in
      affected family members ultimately contributing to the pathogenesis of a bleeding diathesis.
    

Detailed description: 
      As explained in the brief summary, whole exome sequencing (WES) of DNA was performed in a
      family of four patients suffering from unexplained excessive bleeding. It allowed the
      identification of a variant which segregated to family members with bleeding diathesis.
      Firstly, in vitro, functional analyses were performed in primary human endothelial cells.
      Then, in-vivo analysis have to be performed on affected patients.

      The four related patients suffering from excessive bleeding have been followed clinically in
      France for many years. During the follow-up of three of these affected patients, biological
      studies are planned.

      Biological assays include:

        -  Conventional assessment of primary haemostasis: platelet count, platelet aggregation,
           functional and antigen measurement of von Willebrand factor.

        -  Specific testing: Von Willebrand factor multimeric profile, immunolabeling of platelets.

      Conventional assessment is part of the conventional follow-up of patients with inherited
      bleeding disorder. It will not require any additional blood sample. For specific testing and
      after informed consent, fresh blood samples of patients will be collected in 1/10 volume of
      acid-citrate-dextrose and centrifuged for 10 min at 200 g to obtain Platelet-rich plasma
      (PRP) for functional analysis of platelets and Platelet-poor plasma for the multimerization
      state of von Willebrand factor. Then, the results will be compared to the in-vitro findings.
    

Observational model: Family-Based
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        A specific Family
      
Keywords: mucocutaneous bleeding; surgery bleeding outcomes
A Study to Evaluate the Effects of RAD1901 in the Treatment of Vasomotor Symptoms in Postmenopausal Women
Condition: Hot Flashes
MeSH terms: Hot Flashes
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether RAD1901 is effective in decreasing hot
      flashes in postmenopausal women.
    


Intervention name(s): RAD1901; RAD1901; RAD1901; RAD1901; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 10 mg Oral once a day for 28 days.; 25 mg Oral once a day for 28 days; 50 mg Oral once a day for 28 days.; 100 mg Oral once a day for 28 days; Placebo Oral once a day for 28 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: hot flashes; hot flushes; vasomotor symptoms; postmenopausal
ALTO-100 in MDD and/or PTSD
Condition: Major Depressive Disorder; Post Traumatic Stress Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 2

Summary: 
      The goal of this study is to collect biologically based data for defining predictors and
      correlates of the effects of ALTO-100.
    


Intervention name(s): ALTO-100 PO tablet
Intervention type(s): Drug
Intervention description(s): one tablet twice daily
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Dose-Finding Study in Japanese Patients to Evaluate the Effect of Obicetrapib as an Adjunct to Stable Statin Therapy.
Condition: Dyslipidemia; Hypercholesterolemia; High Cholesterol
MeSH terms: Hypercholesterolemia; Dyslipidemias
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will be a placebo-controlled, double-blind, randomized, phase 2 dose-finding study
      in Japanese patients to evaluate the efficacy, safety, and tolerability of obicetrapib as an
      adjunct to stable statin therapy.
    

Detailed description: 
      This study will be a placebo-controlled, double-blind, randomized, phase 2 dose-finding study
      to evaluate the efficacy, safety, and tolerability of obicetrapib as an adjunct to stable
      statin therapy in Japanese patients. The screening period for this study will take up to
      2-weeks. Afterwards, patients will be randomized to placebo, 2.5 mg obicetrapib, 5 mg
      obicetrapib or 10 mg obicetrapib for an 8-week treatment period. After the treatment period,
      patients will continue for a 4-week safety follow-up visit.
    

Intervention name(s): Obicetrapib; Obicetrapib
Intervention type(s): Drug; Drug
Intervention description(s): tablet; No active ingredient
Other intervention name(s): CETP inhibitor; placebo tablet
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Placebo-controlled, double-blind, randomized
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: obicetrapib; statin; LDL-C cholestero; l atherosclerosis
Preventive Effect of Enoxaparin, Pentoxifylline and Ursodeoxycholic Acid to Radiation Induced Liver Toxicity
Condition: Colorectal Cancer; Liver Metastases; Irradiation Damage; Radiation Induced Liver Disease
MeSH terms: Neoplasm Metastasis; Liver Neoplasms; Liver Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate whether a combination regimen of pentoxifylline, ursodeoxycholic acid and
      enoxaparin provides a protective effect on the liver parenchyma after high dose rate (HDR)
      brachytherapy.
    

Detailed description: 
      A preventive effect of pentoxifylline, ursodeoxycholic acid and low dose low molecular weight
      heparin on pathological processes in healthy tissue after irradiation is described in
      clinical studies on percutaneous liver irradiation and on bone marrow transplantation.
      However, data remains inconclusive.

      This exploratory study aims at assessing whether a protective effect of the combination of
      pentoxifylline, ursodeoxycholic acid and enoxaparin can be demonstrated in a limited number
      of patients with liver metastases of colorectal cancer after HDR brachytherapy.

      All patients receive a single fraction CT/MRI-guided HDR-brachytherapy of colorectal liver
      metastases using Iridium-192 as a standard therapy. The follow-up consists of 4 MRI controls
      of the abdomen using the hepatocyte-specific contrast agent Gd-EOB-DTPA (Primovist) after 3
      days, 6 weeks, 3 months and 6 months as well as blood samples and a questionnaire taken the
      same time.Within the study, 22 patients are given low dose low molecular weight heparin,
      pentoxifylline and ursodeoxycholic acid for 8 weeks starting with the preinterventional day.
      Another 22 patient will receive the standard therapy without the medication. After completion
      of the follow-up, MRI volume data of the lesion will be acquired and compared to the
      dosimetric treatment plan. Blood samples are tested for liver-specific and inflammatory
      laboratory parameters.
    

Intervention name(s): Pentoxifylline; Ursodeoxycholic Acid; Enoxaparin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Pentoxifylline is given for 8 weeks since the evening of the day of intervention with a dose of 400mg applied three times daily (morning, noon, evening).; Ursodeoxycholic acid is administered for 8 weeks since the evening of the day of intervention. Dosage is 250mg given three times daily (morning, noon, evening).; Enoxaparin with a dose of 40mg is injected subcutaneously once a day for 8 weeks since the evening of the day of intervention after the HDR-brachytherapy.
Other intervention name(s): Trental (CAS 6493-05-6, ATC C04AD03); Ursofalk (CAS 128-13-2, ATC A05AA02); Clexane (CAS 9005-49-6, ATC B01AB05)
Intervention MeSH terms: Enoxaparin; Pentoxifylline; Ursodeoxycholic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: brachytherapy; liver metastases; irradiation; radiation induced liver disease; dosimetry
Effects of Liothyronine on Energy Expenditure and Cardiovascular Function
Condition: Healthy
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study will assess the short term effects of a single dose of liothyronine on the
      cardiovascular system and energy expenditure
    


Intervention name(s): Liothyronine; Levothyroxine; Placebos
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single dose; Active comparator; Placebo
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: double blind, crossover
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Inverted Internal Limiting Membrane Flap Technique for Macular Hole Retinal Detachment in Highly Myopic Eyes
Condition: Macular Hole Retinal Detachment
MeSH terms: Retinal Detachment; Retinal Perforations; Dissociative Disorders
Study type: Interventional

Summary: 
      To evaluate efficacy of vitrectomy with inverted internal limiting membrane (ILM) flap
      technique for macular hole retinal detachment (MHRD) in highly myopic eyes, and to
      demonstrate postoperative clinical course of MHRD after inverted ILM flap technique using
      swept-source optical coherence tomography (OCT)
    

Detailed description: 
      Macular hole retinal detachment (MHRD) threatens a certain number of highly myopic patients
      for irreversible visual dysfunction, and mostly requires immediate surgical intervention. The
      aim of they study is to evaluate efficacy of vitrectomy with inverted internal limiting
      membrane (ILM) flap technique for MHRD in highly myopic eyes, and to demonstrate
      postoperative clinical course of MHRD after inverted ILM flap technique using swept-source
      optical coherence tomography.
    

Intervention name(s): Vitrectomy
Intervention type(s): Procedure
Intervention description(s): Vitrectomy with inverted ILM technique or ILM peeling
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: vitrectomy; macular hole retinal detachment; high myopia
An Intervention to Improve Nutrition and Physical Activity in Preschoolers in Cuenca, Ecuador
Condition: Obesity; Overweight; Underweight
MeSH terms: Overweight; Thinness
Study type: Interventional

Summary: 
      The aim of this study is to design and evaluate an educational and behavioral intervention
      focused on improving nutrition and physical activity habits among preschoolers in Cuenca,
      Ecuador, with the overarching goal of preventing overweight/obesity and promoting the
      formation of healthy nutrition/physical activity habits.
    

Detailed description: 
      In Ecuador and in the city of Cuenca, the prevalence of obesity is high (approximately 22% of
      the population). Simultaneously, there is high prevalence of chronic malnutrition (e.g.,
      stunting). In a previous study in school-aged children in Cuenca, the prevalence of
      overweight or obese was 30%.

      The objective of this study is to design an intervention to improve nutrition and physical
      activity habits and behaviors in preschoolers. The study will begin with a baseline survey
      that will be used to develop the educational and behavioral intervention. The intervention
      will consist of didactic material for teachers, educational material for parents, and
      activities for the children. The investigators will carry out the intervention over the
      course of the school year. The intervention will be primarily delivered in the preschool
      setting, but will also include workshops for parents.

      The investigators hope that this study will help promote the health of children in Cuenca and
      can be a pilot study to test similar interventions in larger populations in Ecuador.
    

Intervention name(s): Nutrition and physical activity
Intervention type(s): Other
Intervention description(s): The investigators will design an educational and behavioral program focused on health promotion. Didactic material will be developed for teachers and educational material will be developed for parents. For children, the investigators will design educational and playtime materials that encourage healthy eating and physical activity.
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Nutrition; Physical activity; Overweight; Obesity; Malnutrition
Determination of Lung Maturity and Prediction of RDS at Birth
Condition: RDS; Premature Birth
MeSH terms: Premature Birth
Study type: Observational

Summary: 
      The overall objective is to identify quickly after birth the preterm infants who will develop
      respiratory distress syndrome (RDS) for the purpose of treating them as early as possible
      with surfactant, to reduce, and if possible, to avoid sequelae, including long-term oxygen
      treatment.

      We have therefore developed a quick test, which we believe will be ideal for this type of
      diagnostics, and will now test the method in a preclinical trial.
    

Detailed description: 
      In at least 135 preterm infants with gestational age 24-32 weeks we will collect gastric
      aspirate and hypopharyngeal secretion. The infants are stratified into three groups:
      gestational age 24-25 weeks, 26-29 weeks and 30-31 weeks.

      The aspirates will be frozen at -20 centigrade and lecithin-sphingomyelin ratio (L/S) will be
      analysed retrospectively using Fourier Transform Infrared Spectroscopy.

      The infants will be monitored for the first five days with regard to possible development of
      RDS.

      Clinical and biochemical data will be compared retrospectively.

      There a no intervention procedures.
    

Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        135 preterm infants with gestational age 24-32 weeks (24+0 to 31+6)
      
Biospecimen description: 
      Gastric- and hypopharyngeal secretions
    
Keywords: Lung maturity; RDS; Prematurity; Lecithin-sphingomyelin ratio; Spectroscopy; Chemometrics
Immunological and Histological Evaluation of Specific Immunotherapy With Recombinant Hypoallergenic Derivative
Condition: Allergic Rhinoconjunctivitis
Study type: Interventional
Phase: Phase 2

Summary: 
      This trial is performed for the immunological and histological evaluation of specific
      immunotherapy with an aluminium hydroxide-adsorbed recombinant hypoallergenic derivative of
      the major birch pollen allergen, rBet v1-FV
    

Detailed description: 
      Type I allergy is an immune-disorder which stems from the formation of IgE antibodies against
      proteins and glycoproteins from plants, insects, animals and fungi, most of which are
      normally considered harmless. The cross-linking of specific IgE antibodies on effector cells
      by allergens activates an immunological cascade leading to the symptoms of Type I allergy
      including rhinitis, conjunctivitis, asthma, and anaphylactic shock. Allergic Rhinitis is the
      most common chronic atopic disease and is associated with considerable cost and co-morbidity.
      Seasonal allergic rhinitis (SAR), triggered by pollen from trees, grasses and weeds, is
      characterized by sneezing, nasal congestion, nasal itching, rhinorrhea, and pruritic, watery,
      red eyes.

      Recombinant preparations offer various advantages over those based on natural allergen
      extracts. Recombinant proteins can be produced in highly purified forms of pharmaceutical
      quality; proteins are molecularly defined thus ensuring product consistency and minimising
      problems related to allergen extract standardisation; preparations only include those
      proteins that are considered relevant for specific immunotherapy; the risk of contamination
      with other allergenic material is excluded; the whole production process can be designed to
      exclude any risk factors for the introduction of infectious agents; the relative dosages of
      individual components of a final preparation can be optimised to favour better clinical
      efficacy. Allergy vaccination (AV) mediates the immune response to allergen exposure by
      altering the TH2 response in favour of a TH1 T-cell response, increasing IgG production and
      decreasing the production of inflammatory cytokines. rBet v1-FV is an AV designed to enhance
      beneficial immune responses. The investigational product has demonstrated efficacy and good
      tolerability in one previous pivotal Phase III and two previous Phase II studies.
    

Intervention name(s): Placebo; rBet v1-FV
Intervention type(s): Other; Biological
Intervention description(s): Placebo was given the same way as a subcutaneous (just under the skin) injection.; Placebo was given the same way as a subcutaneous (just under the skin) injection.
Other intervention name(s): Comparator; Specific Immunotherapy
Intervention MeSH terms: Immunomodulating Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Specific immunotherapy; SIT; SCIT; recombinant; Type 1 - Allergy
The Impact of Local Analgesia for Postoperative Analgesia in Posterior Thoracolumbar Operation
Condition: Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      Posterior thoracolumbar operation always chooses general anesthesia. Due to surgical trauma
      and rich periosteum and joint capsule innervation, patients after general anesthesia
      immediately feel acute pain.The use of appropriate postoperative analgesia in patients with
      thoracolumbar surgery is beneficial to postoperative recovery. Infusions of local anaesthetic
      via multilumen catheters that deliver directly to wound sites have been used for
      postoperative analgesia in procedures. Reducing the morbidity from both pain and nausea will
      make the mode of analgesia a better tolerated and more palatable option for patients. The aim
      of this study is to examine the effects of using local anaesthetic infusion catheters
      following posterior thoracolumbar surgery, and compares the outcomes of patients managed
      using intravenous analgesia pump infusion of systemic opioids.
    

Detailed description: 
      All 71 adult patients were prospectively included and randomized to either the local (L)
      group (n=35) or the intravenous (V) group (n=36) by using a random number table: the test
      group were treated with local analgesia infusion pump of 0.33% ropivacaine through the wound
      for postoperative analgesia, while the control group were treated with intravenous analgesia
      pump infusion of flurbiprofen axetil,palonosetron, pentazocine. At 2, 4, 6, 12, 24, 36, 48
      hours after operation, postoperative pain visual analogue scale(VAS) scores and sedation
      Ramsay scores were used to evaluate the level of pain and sedation, and investigators
      documented the comprehensive evaluation of patients with pain control system, and the
      incidence of adverse reactions. At 24, 48 hours investigators observed the wound whether
      inflammation and exudation or not, and the removal of penetration catheter sent to clinical
      laboratory for bacterial culture. Investigators also recorded the length of time to discharge
      and called to ask pain conditions at the first 3 months.
    

Intervention name(s): local; intravenous; 0.33% ropivacaine 250ml; flurbiprofen axetil 150mg,palonosetron 0.5mg,pentazocine 240mg.
Intervention type(s): Other; Other; Drug; Drug
Intervention description(s): This group uses local analgesia infusion pump of 0.33% ropivacaine 250ml through the wound for postoperative analgesia.; This group is treated with intravenous analgesia pump infusion of flurbiprofen axetil 150mg,palonosetron 0.5mg,pentazocine 240mg.
Intervention MeSH terms: Flurbiprofen; Flurbiprofen axetil; Pentazocine; Palonosetron; Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Local analgesia system; Ropivacaine; Analgesic efficacy after operation; Postoperative
Effect of Arshvidya After School Program on Cognitive Processes in Elementary School Children
Condition: Cognitive Change
Study type: Interventional

Summary: 
      The impact of Arsha Vidya program on cognitive performance was examined in elementary school
      children. The study compares the effects of arsha vidya after school routine with usual after
      school routine in healthy 8-11 year-old Indian children.

      The main objective of the study is to investigate the effect on cognitive function, behaviour
      and emotions.
    


Intervention name(s): Arsha Vidya chldren's Group; Usual Activity group
Intervention type(s): Other; Other
Intervention description(s): Yoga, Vedic chants, Vedant sessions, Gita sessions and group activities within the Gurukulam (centre); Usual after school activities at home.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other