bioihbjkbjnl/mcl2 huggingface dataset:
Impact of Umbilical Cord Clamping Time on Infant Anemia
Condition: Third Stage of Labor; Healthy; Umbilical Cord Clamping Time; Infant Conditions
MeSH terms: Anemia
Study type: Interventional

Summary: 
      This research was conducted to carry out the effect of umbilical cord clamping time on baby
      anemia.
    

Detailed description: 
      This study is an experimental, randomized controlled study. The sample of the study consisted
      of 65 pregnant women and newborns (intervention=32, control=33) who applied for delivery at
      Ege University Medical Hospital Gynecology and Obstetrics Clinic at the time of the study. In
      this study, "Descriptive Data Form of Impact of Umbilical Cord Clamping Time on Infant
      Anemia" was used as a data collection tool. In the intervention group waited 60 seconds for
      umbilical cord clamping in the second stage of labor, in the control group the umbilical cord
      was clamped in the first 15 seconds. For the data of the first stage of the study, the
      neonatal hematocrit and bilirubin measurements and the need for phototherapy due to
      hyperbilirubinemia were evaluated 48 hours after birth. In the second stage of the study,
      data on anaemia screening performed in family medicine at the end of the fourth month of
      birth were examined. Statistical analysis of the data from the study was performed using IBM
      SPSS Statistics 25.0 package program. Parametric tests were used for statistical analysis of
      the data with a normal distribution. The level of statistical significance was determined as
      p<0.05.
    

Intervention name(s): Delayed Clamping
Intervention type(s): Procedure
Intervention description(s): Umbilical cord clamping was delayed 60 seconds at the end of second stage of labor.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: umbilical cord; clamping; infant; anemia; midwifery
Hyaluronic Acid Filler IMD1 Basic for Correction of Nasolabial Folds
Condition: Nasolabial Folds
Study type: Interventional
Phase: Phase 4

Summary: 
      Volunteers receive one injection IMD1 basic of correction of nasolabial folds and are
      followed-up for up to 36 weeks.
    


Intervention name(s): Hyaluronic acid filler/IMD1 basic
Intervention type(s): Drug
Intervention MeSH terms: Hyaluronic Acid
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of LY3185643 and rGlucagon in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine how the body handles LY3185643 and rGlucagon and
      what effects LY3185643 and rGlucagon have on the body. This study will also help to determine
      if LY3185643 is safe and well-tolerated.

      This study will last at least 35 days, not including screening.
    


Intervention name(s): LY3185643; rGlucagon
Intervention type(s): Drug; Drug
Intervention description(s): Administered SC; Administered SC
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Pharmacokinetics of Insulin Detemir in Healthy Volunteers From Taiwan
Condition: Diabetes; Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Asia. The aim of this trial is to investigate pharmacokinetics of
      insulin detemir in healthy Taiwanese subjects.
    


Intervention name(s): insulin detemir
Intervention type(s): Drug
Intervention description(s): Single dose, 0.5 U/kg, administered s.c. (under the skin)
Intervention MeSH terms: Insulin Detemir
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of LIPO-5 and ALVAC-HIV (vCP1452) as Possible HIV Vaccines
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study will test the immune system response to and safety of two HIV vaccines alone and
      in combination: ALVAC-HIV (vCP1452) and LIPO-5. ALVAC-HIV (vCP1452) uses a canarypox virus
      with man-made parts of HIV attached to it. The canarypox virus cannot cause disease in
      people. LIPO-5 is a mixture of five man-made proteins similar to proteins found in HIV.

      These vaccines are not produced from live HIV or from infected cells and do not contain the
      virus. It is not possible to become infected with HIV from these vaccines.
    

Detailed description: 
      Immune priming of cytotoxic T lymphocytes (CTLs) has been most successfully achieved with
      live attenuated virus or live virus vector vaccines. Recombinant canarypox vaccines have an
      excellent safety record and have induced HIV neutralizing antibodies and CTLs in early
      clinical trials. This study will evaluate the use of HIV lipopeptides (LIPO-5) alone and in
      combination with a canarypox-based HIV vaccine [ALVAC-HIV (vCP1452)] to further increase CTL
      activity.

      Participants in this study will be randomly assigned to one of five groups. Participants in
      Groups A and B will receive four injections over 6 months. Participants in Group A will
      receive four injections of either LIPO-5 or a placebo. Participants in Group B will receive
      four injections of either the ALVAC-HIV (vCP1452) or a placebo. Participants in Groups C, D,
      and E will receive six injections over 6 months. Participants in these groups will receive
      either ALVAC-HIV (vCP1452) and LIPO-5 or a placebo. Participants who receive the vaccine
      combination will receive four injections of the same dose of ALVAC-HIV (vCP1452) and two
      injections of LIPO-5. The dose of LIPO-5 will be different for participants in Groups C, D,
      and E.

      Participants will have 11 study visits over 18 months; the total duration of the study will
      be 30 months. The length of visits will vary and may last up to 3 hours. Study visits will
      include a medical interview, brief physical exam, and blood and urine tests. Participants
      will be tested for HIV before entering the study and at least five times during the study.
      All vaccine and placebo injections will be given in the upper arm muscle.
    

Intervention name(s): ALVAC-HIV (vCP1452); LIPO-5
Intervention type(s): Biological; Biological
Intervention description(s): experimental vaccine; experimental vaccine
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: HIV Seronegativity; ALVAC-HIV vCP1452; ALVAC Vaccine; HIV-1; Normal Values; HIV Preventive Vaccine
Personalized Objects Can Improve the Diagnosis of EMCS From MCS
Condition: Patients in Minimally Conscious State
MeSH terms: Persistent Vegetative State
Study type: Interventional

Summary: 
      In this study，researchers will use personalized objects to assess patients' level of
      consciousness in chronic patients in minimally conscious state (MCS).
    

Detailed description: 
      The Coma Recovery Scale-Revised (CRS-R) is an important tool for the assessment of behaviors
      in DOC.Clinical practice has shown that self-referential stimuli, such as the patient's own
      name and face, are more effective to elicit the patient's response than that of
      non-self-referential stimuli.

      The item "Functional Object Use" was assessed by using personalized objects (e.g., cigarette,
      paper) and non-personalized objects, which presented in a random order.The rest assessments
      were performed following the standard protocol of CRS-R. The differences between functional
      use of the two types of objects was analyzed by Chi-square test.

      Researchers expected to see some of the patients in MCS are re-diagnosed as EMCS with the
      using of personalized objects.
    

Intervention name(s): Personalized Objects; non-personalized Objects
Intervention type(s): Behavioral; Behavioral
Intervention description(s): personalized objects are based on the observation or the reports from family; non-personalized objects are based on the suggestion in CRS-R,which are comb and cup
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Diagnostic
Outcome of Transarterial Chemo-embolization (TACE) in Hepatocellular Carcinoma Patients With Partial Portal Vein Thrombosis
Condition: Hepatocellular Carcinoma (HCC)
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Interventional
Phase: Phase 4

Summary: 
      Portal vein tumor invasion (PVT) is a common complication in HCC. the studyb Aimed to assess
      the outcomes after TACE in patients with branch PVT regarding Child classification,
      radiological response and 1 year survival.
    

Detailed description: 
      Thirty HCC patients (24 male, 6 females) Child A cirrhotics with branch PVT. Follow up was
      done at 1, 3, 6 and 12 months after first TACE. All patients underwent laboratory
      investigations including liver function tests to assess deterioration in liver functions,
      triphasic spiral CT to assess radiological response according to mRECIST criteria. Survival
      analysis was performed using Kaplan-Meier estimations.
    

Intervention name(s): transarterial chemoembolization versus the standard treatment with sorafinib
Intervention type(s): Procedure
Intervention description(s): TACE procedures were performed by the interventional radiologist through femoral artery approach in all patients. Super-selective cannulation of the main feeders was performed using a microcatheter whenever possible. The c-TACE protocol consisted of intra-arterial infusion of cisplatin 50-100 mg mixed with lipiodol ,Just prior to injection, emulsion is prepared by intensive mixing of equal volumes of cytotoxic drug solution and iodized oil using the pumping method with two syringes and a three way stop cock. Injection is guided by fluoroscopy and results in dense accumulation of the emulsion within the tumor vascular bed. Injection of poor iodized oil up to a maximum volume of 10-20 cc is an option and is followed by embolization of feeding arteries by Gelfoam cubes .Endpoints of conventional TACE are complete filling of the tumor vascular bed with iodized oil and stop-flow in subsegmental and segmental feeding arteries..
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Assess Bioequivalence and Adhesion Properties Between Two Granisetron Transdermal Patches.
Condition: Healthy Volunteers
MeSH terms: Tissue Adhesions
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is designed to evaluate the BE and adhesion properties of granisetron transdermal
      patches manufactured at 2 different sites. The study has been designed in accordance with the
      FDA Guidance for Industry. Bioequivalence will be based on the Cmax and AUC to determine the
      peak and total drug exposure, respectively.
    

Detailed description: 
      This is a single-center, randomized, 2-part, open-label, crossover study in healthy subjects
      to establish bioequivalence (Part 1) and evaluate adhesion (Part 2) between granisetron
      transdermal patches manufactured at 2 different sites (Sancuso [test] and Sancuso
      [reference]).

      Each part of the study will consist of a screening period, check-in days, treatment periods,
      washout period (Part 1 only), and an end-of-study visit. The duration of subject
      participation, excluding screening, for Part 1 is approximately 39 days and for Part 2 is
      approximately 17 days.
    

Intervention name(s): Sancuso - Part 1; Sancuso - Part 2
Intervention type(s): Drug; Drug
Intervention description(s): Part 1 - A Potent anti-emetic and highly selective antagonist of 5-HT3 receptors.; Part 2 - A Potent anti-emetic and highly selective antagonist of 5-HT3 receptors.
Other intervention name(s): Granisetron Transdermal Patch; Granisetron Transdermal Patch
Intervention MeSH terms: Granisetron
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This is a single-center, randomized, 2-part, open-label, crossover study in healthy subjects to establish BE (Part 1) and evaluate adhesion (Part 2) between granisetron transdermal patches.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Patch; Nausea; Anti-emetic; Granisetron
Effect of Long Term Cocoa Flavanol Intake on Blood Pressure and Platelet Function in Healthy Adults, Part 1
Condition: Healthy
Study type: Interventional

Summary: 
      Flavanols are plant-derived compounds commonly present in the human diet. Examples of
      flavanol-containing foods and beverages are apples, chocolate, tea, wine, berries,
      pomegranate and nuts. The consumption of flavanol-containing foods and beverages has been
      associated with improvements in cardiovascular health. In this study, the investigators hope
      to learn more about the effects of the consumption of increasing amounts of cocoa flavanols
      on blood pressure, platelet function and other metabolic parameters in healthy humans. This
      study was followed by a second study that aimed at investigating the effects of long term
      consumptions of cocoa flavanols on blood pressure, platelet function and other metabolic
      parameters in healthy humans.
    


Intervention name(s): Mars Cocoa Extract Capsules
Intervention type(s): Dietary Supplement
Intervention description(s): Capsules containing Mars Cocoa Extract manufactured by the Cocoapro® process, providing 500 mg of cocoa flavanols per capsule: 1000 mg of cocoa flavanols consumed daily during week 1 and 2, 1500 mg of cocoa flavanols consumed daily during week 3 and 4, and 2000 mg of cocoa flavanols consumed daily during week 5 and 6, and no capsule consumed (washout) during week 7 and 8.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Flavanols; Cocoa flavanols; Blood pressure; Platelet Function
Clinical Pharmacological Study of AL-43546 Ophthalmic Product in Subjects With Shortened Tear Film Break Up Time
Condition: Dry Eye Disease
MeSH terms: Dry Eye Syndromes; Eye Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to observe lacrimal fluid condition (tear film break-up time)
      chronologically after a single dose of AL-43546 ophthalmic products（0.15%, 0.25% and
      vehicle）and 0.1% sodium hyaluronate ophthalmic solution and compare lacrimal fluid retention
      time between them.
    


Intervention name(s): Hydroxypropyl Guar Galactomannan; 0.1% sodium hyaluronate ophthalmic solution
Intervention type(s): Drug; Drug
Intervention description(s): One drop per one time in both eyes, once daily (at each visit).One instillation daily in one period and a total of 4 instillations over 4 periods.; One drop per one time in both eyes, once daily (at each visit).One instillation daily in one period and a total of 4 instillations over 4 periods.
Intervention MeSH terms: Ophthalmic Solutions; Hyaluronic Acid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
EVALUATION OF BONE PARAMETERS IN PATIENTS WITH PATELLO-FEMORAL DISORDERS
Condition: Patello Femoral Syndrome
MeSH terms: Patellofemoral Pain Syndrome
Study type: Interventional

Summary: 
      The aim of the study is to compare, in patients with patellofemoral joint disorders, the
      values related to the bone indexes of this joint, obtained from CT performed both in
      orthostatism and clinostatism
    

Detailed description: 
      The aim of the study is to compare, in patients with patellofemoral joint disorders, the
      values related to the bone indexes of this joint, obtained from CT performed both in
      orthostatism and clinostatism.

      Young patients with patellofemoral joint pathology, for which a diagnostic examination is
      necessary in order to determine a possible surgical indication, will be included in this
      pilot study, and will be evaluated using the "Cone Beam Computed Tomography "(CBCT), a
      machine that use a low dose of radiation compared to traditional CT systems, and allows the
      examination in supine and standing position knee . In this way, for the same patient it will
      be possible to calculate the bone indexes both in weight-bearing condition and in
      non-weight-bearing, comparing the values between them, to identify possible differences due
      to the influence of orthostatism.
    

Intervention name(s): "Cone Beam Computed Tomography" (CBCT)
Intervention type(s): Diagnostic Test
Intervention description(s): "Cone Beam Computed Tomography "(CBCT), a machine that use a low dose of radiation compared to traditional CT systems, and allows the examination in supine and standing position knee . In this way, for the same patient it will be possible to calculate the bone indexes both in weight-bearing condition and in non-weight-bearing, comparing the values between them, to identify possible differences due to the influence of orthostatism.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: CT
Medication Adherence in Children Who Had a Liver Transplant
Condition: Pediatric Recipients of a Liver Transplant
Study type: Observational

Summary: 
      The purpose of this study is to evaluate the use of a novel method to measure adherence to
      immunosuppressant medications in predicting rejection episodes in children who had a liver
      transplant.
    

Detailed description: 
      During the course of their illness as many as 50% of children who had a liver transplant stop
      taking their medications. Non-adherence is the most important reason for organ rejection in
      long term survivors of pediatric liver transplantation. In order to address this important
      risk-factor effectively, the first step is to evaluate a method that would identify
      non-adherence in these children. Medication blood levels that are obtained as a part of
      clinical practice in transplant centers can be used to determine whether the patient is
      adherent or not. This multi-center observational study tests the ability of an objective
      measure of adherence to immunosuppressant medications that involves the use of routinely
      obtained tacrolimus blood levels to predict organ rejection in children who had a liver
      transplant.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pediatric patients receiving liver transplantation
      
Biospecimen description: 
      liver tissue samples (from biopsies performed for clinical, not investigational, reasons)
    
Keywords: Liver transplant; Adherence; Compliance; Tacrolimus
Efficacy of SNRI Treatment on Prefrontality in Patients With GAD and Other Comorbities
Condition: Generalized Anxiety Disorder
MeSH terms: Anxiety Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      This is an open-label flexible-dose pilot study evaluating the efficacy, safety, and
      tolerability of Pristiq (desvenlafaxine) in outpatient subjects diagnosed with Generalized
      Anxiety Disorder (GAD) with or without comorbidities that are secondary to the GAD. Primary
      trial objective is to evaluate the efficacy of Pristiq (desvenlafaxine) SNRI treatment 50 to
      100 mg once daily in the treatment of GAD with or without comorbidities. Secondary trial
      objective is to determine whether or not treatment outcome in GAD is related to changes in
      cortical prefrontal activity of norepinephrine.
    


Intervention name(s): Desvenlafaxine
Intervention type(s): Drug
Other intervention name(s): Pristiq
Intervention MeSH terms: Desvenlafaxine Succinate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Drug-Drug Interaction Study to Investigate Effects of Voclosporin on Pharmacokinetics of Simvastatin
Condition: Drug-drug Interaction
Study type: Interventional
Phase: Phase 1

Summary: 
      A single-center, open-label, Phase 1, drug-drug interaction study to investigate the effect
      of voclosporin on the pharmacokinetics of simvastatin and simvastatin acid in healthy
      volunteers.
    


Intervention name(s): Simvastatin; Voclosporin
Intervention type(s): Drug; Drug
Intervention description(s): Oral dose 40 mg; Oral dose 23.7 mg twice daily
Intervention MeSH terms: Simvastatin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: voclosporin; simvastatin; pharmacokinetics; drug effects; drug interactions
Zushima Plaster for Treating Knee Osteoarthritis
Condition: Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to further evaluate the clinical efficacy and safety of Zushima
      plaster for patients in knee osteoarthrosis post-marketing.
    


Intervention name(s): Zushima plaster with high dose; Zushima plaster with low dose; Indometacin Cataplasms
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Patients in high dose Zushima plaster group will use Zushima plaster topically on knee(s) for 24h per day.; Patients in low dose Zushima plaster group will use Zushima plaster topically on knee(s) for 12h per day.; Patients in Indometacin Cataplasms group will use Indometacin Cataplasms on knee(s)for 24h per day.
Intervention MeSH terms: Indomethacin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Knee Osteoarthritis
Effect of Teduglutide on Gastric Emptying in Healthy Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to assess the effects of 10 consecutive, daily,
      subcutaneous doses of 4 mg of teduglutide as compared with placebo on gastric emptying as
      assessed by acetaminophen absorption kinetics in healthy subjects.
    


Intervention name(s): Placebo; teduglutide
Intervention type(s): Drug; Drug
Intervention description(s): placebo; teduglutide 4 mg
Intervention MeSH terms: Teduglutide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Pharmacokinetics; Pharmacodynamics; teduglutide