bioihbjkbjnl/mcl2 huggingface dataset:
Modified Natural Cycle Offers a Chance of Pregnancy in Patients With Poor Response and High Basal FSH
Condition: Infertility; Premature Ovarian Failure
MeSH terms: Infertility; Primary Ovarian Insufficiency; Menopause, Premature
Study type: Observational

Summary: 
      The purpose of this study is to evaluate the effectiveness of a modified natural cycle in
      patients with previous poor response to infertility drugs and high basal FSH, prior to
      proceeding to oocyte donation or abandoning fertility treatment.
    

Detailed description: 
      Poor responders are a diverse group of IVF patients who fail to respond to IVF drugs. In
      these patients pregnancy rates remain disappointingly low and usually oocyte donation is
      their only viable option. The need for lengthy ovarian stimulation regimes can be avoided by
      performing IVF during a natural menstrual cycle. However, the main problem with a natural
      cycle is that successful IVF outcome can be compromised by a premature LH surge. This problem
      can be solved by the administration of GnRH antagonists that suppress endogenous gonadotropin
      levels, comprising a modified natural cycle (MNC). Previous studies have shown that MNC
      offers no realistic chances of pregnancy prior to oocyte donation. In this study we will
      re-assess this view by showing that MNC offers some, albeit small, chances of positive IVF
      outcome in patients with known previous poor response prior to oocyte donation.
    

Intervention name(s): recombinant FSH (Puregon, Organon, The Netherlands); GnRH antag: Ganirelix (Orgalutran, Organon, The Netherlands); hCG (Pregnyl, Organon, The Netherlands)
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Chorionic Gonadotropin; Ganirelix
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women undergoing IVF treatment
      
Keywords: GnRH antagonist; Poor responders; Oocyte donation; Modified natural cycle
Oropharyngeal Administration of Colostrum to Very Low Birth Weight Infants
Condition: Infant, Very Low Birth Weight
MeSH terms: Body Weight; Birth Weight
Study type: Interventional

Summary: 
      The purpose of this study is to explore the effects of Oropharyngeal administration of
      colostrum to very low birth weight infants on sIgA and lactoferrin, in order to explore the
      protect immune function of colostrum to very low birth weight infants, to improve the
      utilization of breast milk and reduce infection rates of very low birth weight infants.
    

Detailed description: 
      The number of very low born weight infants increased every year.they are suffer from many
      questions.Recent studies have shown that Oropharyngeal administration of colostrum to very
      low birth weight infants can reduce the time reach full enteral nutrition .But there are no
      evidence support that it can promote infants' immune response. The hypothesis of the current
      study is that Oropharyngeal administration of colostrum to very low birth weight infants may
      increase the secretion of sIgA in urine and saliva.

      The current study adopts randomized, double blind, controlled intervention trial, gives
      Oropharyngeal administration of colostrums to very low birth weight infants in intervention
      group and Oropharyngeal administration of Normal saline to control group. All indicators in
      this study are discrete traits, for sIgA、Lactoferrin number in Saliva and urine， number of
      CRP，time Begin oral feeding，time up to full enteral feeding， Person's chi-square tests were
      used for comparisons. For Blood culture results，The number of necrotizing enterocolitis (NEC)
      occurred， the investigators use Chi-square tests for comparisons between two groups. The
      study expects that Oropharyngeal administration of colostrum to very low birth weight infants
      can increase the secretion of sIgA in urine and saliva.
    

Intervention name(s): Oropharyngeal administration of colostrums; Oropharyngeal administration of Normal saline
Intervention type(s): Procedure; Procedure
Intervention description(s): rubbing drops of colostrum inside a baby's cheeks using a sterile syringe; rubbing drops of Normal saline inside a baby's cheeks using a sterile syringe
Other intervention name(s): oral immune therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: oropharyngeal; breastmilk; colostrum; human milk; premature infant
Bioequivalence Minocycline Bioequivalence
Condition: Skin Infections (Acne)
MeSH terms: Cellulitis; Skin Diseases, Infectious
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of the study is to compare the bioavailability of two medications containing 100 mg
      of minocycline in capsules to determine bioequivalence. They are Minocycline (Minocin® is a
      registered trademark of Wyeth Holdings Corporation), and Minocycline (Minopac® is a
      registered trademark of LABORATORIOS DERMATOLOGICOS DARIER, S.A. DE C.V.). Study design is
      randomized, open, cross-over with two single administrations with two periods and two
      sequences with a wash-out period of 7 days between the periods. Subjects in the study will be
      25 healthy male volunteers, 18-55 years, Blood samples will be obtained at 0.0, 0.33, 0.66,
      1.0, 1.33, 1.66, 2.0, 2.33, 2.66, 3.0, 4.0, 6.0, 8.0, 12.0, 16.0, 24.0, 48.0, and 72.0 hours
      after medication administration in each period. Plasma minocycline levels will be determined
      by HPLC method with UV detection with previously validated method. Minocycline concentration
      data will be used to calculate Cmax, AUC0-t, and AUC0-inf with WinNonlin 5.3 software. The
      log transformed pharmacokinetics parameters of test and reference medications will be
      compared calculating ratios and 90% confidence intervals. Any adverse event will be reported.
    


Intervention name(s): Minocycline 100mg; Minocycline 100mg
Intervention type(s): Drug; Drug
Intervention description(s): Test product; Reference product
Other intervention name(s): MINOPAC® is a registered trademark of LABORATORIOS DERMATOLOGICOS DARIER; S.A. DE C.V.; MINOCIN® is a registered trademark of Wyeth Holdings Corporation
Intervention MeSH terms: Minocycline
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Minocycline; Mexico; Acne; bioequivalence
The Role of CVP and EF in Patients With Cardio-renal Syndromes
Condition: Heart Failure
MeSH terms: Cardio-Renal Syndrome
Study type: Observational

Summary: 
      The aim of the study is to explore association between increased central venous pressure,
      Ejection Fraction and renal dysfunction (eGFR) in patients with Cardio-Renal Syndromes type 1
      and 2. The pilot study was set to provide the expected correlation coefficient for a sample
      size determination of the subsequent study.
    

Detailed description: 
      OBJECTIVES

      The aim of the study is to explore association between increased central venous pressure
      (CVP), Ejection Fraction (EF) and renal dysfunction (eGFR) in patients with Cardio-Renal
      Syndromes type 1 and 2.

      BACKGROUND

      The pathophysiology of impaired renal function in cardiovascular disease is multifactorial.
      Recent investigations suggest that management of patients based on low-flow theory does not
      lead to improved outcomes. Relative importance of right heart dysfunction (manifested as
      increased CVP) has not been evaluated . Precise understanding of bidirectional pathways by
      which the heart and kidneys influence each other is necessary to define optimal treatment
      strategies specific to the subtypes, as therapies directed towards one organ system may have
      beneficial or unfavorable effects on the other.

      METHODS

      The study is of non-experimental (observational) type, based on retrospective chart review.
      The patients' personal identifiers are concealed and an anonymized datasets used (unique code
      given to each patient, which is kept secure under the control of hospital staff).
    

Intervention name(s): CVP measurement
Intervention type(s): Other
Intervention description(s): CVP measurements had been performed with an electronic pressure transducer in spontaneously breathing non-ventilated patients. Central vein access was established trough the subclavian or internal jugular veins. Mean CVP was recorded for each patient, measured in mmHg.
Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        patients who underwent in-patient treatment at medical centers
      
Keywords: cardio-renal syndrome; right heart dysfunction; central venous pressure; eGFR; low-flow theory
Pharmacokinetic Study of Tesmilifene (YMB1002) Plus Epirubicin and Cyclophosphamide in Metastatic Breast Cancer
Condition: Metastatic/Recurrent Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I, multi-centre, open-label, cross-over pharmacokinetic study designed to
      investigate whether the co-administration of a fixed dose of tesmilifene alters the plasma
      pharmacokinetics of a standard regimen of epirubicin and/or its principle metabolite,
      epirubicinol and cyclophosphamide.
    

Detailed description: 
      This is a Phase I, multi-centre, open-label, cross-over pharmacokinetic study designed to
      investigate whether the co-administration of a fixed dose of tesmilifene alters the plasma
      pharmacokinetics of a standard regimen of epirubicin and/or it's principle metabolite,
      epirubicinol and cyclophosphamide. The plasma pharmacokinetics of epirubicin/epirubicinol and
      cyclophosphamide when given alone or concurrently with tesmilifene will be examined. Safety
      information for the tesmilifene/ epirubicin and cyclophosphamide combination and for
      epirubicin and cyclophosphamide alone in this patient population will also be collected.
    

Intervention name(s): Tesmilifene (YMB 1002)
Intervention type(s): Drug
Intervention MeSH terms: Tesmilifene
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Tesmilifene; DPPE; Breast cancer; Cyclophosphamide; Epirubicin; Pharmacokinetic
Escitalopram Trial for Irritable Bowel Syndrome (IBS) Patients With Panic Disorder
Condition: Irritable Bowel Syndrome; Panic Disorder
MeSH terms: Irritable Bowel Syndrome; Syndrome; Panic Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will be executed according to a randomized double-blind placebo-controlled trial
      with two parallel groups, treated over the period of 6 months with escitalopram or placebo.

      Hypotheses: Escitalopram is more effective than placebo in the control of gastrointestinal
      symptoms, in irritable bowel syndrome (IBS) patients with panic disorder. Escitalopram is
      more effective than placebo in the control of psychiatric symptoms, in IBS patients with
      panic disorder.
    


Intervention name(s): Escitalopram
Intervention type(s): Drug
Intervention description(s): Patients will start at a dosage of 5 mg daily of escitalopram. After the first week of treatment the dosage will be increased to 10 mg daily. During the visits, the dosage can be gradually increased to a maximum of 20 mg daily, depending on the response of the patient.
Other intervention name(s): Lexapro
Intervention MeSH terms: Escitalopram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Randomized controlled trial; Escitalopram; Irritable bowel syndrome; Panic disorder
Long-Term Study of Hydrocodone Bitartrate Controlled-release Capsules in Subjects With Chronic Pain
Condition: Chronic Pain
MeSH terms: Chronic Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      This Phase 3, multi-center study will evaluate the long-term safety and tolerability of
      hydrocodone bitartrate controlled release capsule (HC-CR) at daily doses of 40 mg or more in
      subjects with moderate to severe chronic pain. Long-term maintenance of HC-CR efficacy will
      be evaluated.
    

Detailed description: 
      Subjects will go through screening, an open-label conversion and titration phase of up to 6
      weeks followed by an open-label treatment phase for up to 48 weeks with a 2 week follow-up
      period.
    

Intervention name(s): Hydrocodone Bitartrate
Intervention type(s): Drug
Intervention description(s): Open-Label, Capsule Strengths 10 mg, 20 mg, 30 mg, 40 mg, 50 mg; by mouth (PO) twice a day (BID) for up to 48 weeks
Other intervention name(s): Hydrocodone Bitartrate Controlled Release (HC-CR)
Intervention MeSH terms: Hydrocodone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: chronic pain
Effect of Androgel on Type 2 Diabetic Males With Hypogonadism
Condition: Diabetes Mellitus Type 2
MeSH terms: Diabetes Mellitus, Type 2; Hypogonadism
Study type: Interventional
Phase: Phase 4

Summary: 
      This is to study the effect of replacing testosterone on different inflammatory cells in type
      2 diabetics with low testosterone levels.
    

Detailed description: 
      Type 2 diabetes is an atherosclerotic, pro-inflammatory and pro-oxidative stress.
      Hypogonadism( low testosterone) is also associated with increased levels of inflammatory
      mediators and atherosclerosis.

      This project is about studying the effect of testosterone replacement on different
      inflammatory cells in blood and urine. It will also compare the dose dependent effect on
      inflammatory cells. This also involves comparing level of inflammation in hypogonadic
      diabetic males treated with testosterone with those not treated with any replacement therapy.

      This study involves applying AndroGel for 8 wks and studying effects during this time and
      thereafter.
    

Intervention name(s): androgel; androgel 10g; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): androgel 5g; androgel 10g; placebo
Other intervention name(s): androgel
Intervention MeSH terms: Methyltestosterone; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Diagnostic
Keywords: DM type 2; Hypogonadism; Testosterone; AndroGel
Pegylated Interferon Alfa-2a for Dialysis Patients With Acute Hepatitis C
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      Interferon-based monotherapy has been considered effective to treat acute hepatitis C in
      ordinary patients. However, the efficacy of this treatment has not been evaluated in
      prospective interventional studies for dialysis patients. The aim of the study is the
      evaluate the efficacy of peginterferon alfa-2a monotherapy for 24 weeks in this special
      clinical setting, and concomitantly evaluate retrospectively the dialysis patients with acute
      hepatitis C who did not receive intervention as the reference.
    

Detailed description: 
      Chronic viral hepatitis is common in dialysis patients, with the reported prevalence and
      annual incidence of 3-80% and 2.9%, respectively. The high incidence and prevalence in thse
      patients are attributed to potential nosocomial exposure to hepatitis C virus during
      dialysis, resulting in high rates of acute hepatitis C virus infection. It is estimated that
      about 65-80% of the patients who have acute hepatitis C will evolve to chronic infection,
      leading to chronic hepatitis, cirrhosis, hepatic decompensation, and hepatocellular carcinoma
      (HCC). Currently, interferon and pegylated interferon monotherapy remains effective to treat
      acute hepatitis C in ordinary patients, with the sustained virologic response (SVR) rates
      ranging from 65-90% after 12-24 weeks of therapy. However, few data regarding the efficacy
      and safety of interferon-based monotherapy is known till now. Treatment of weekly 135
      pegylated interferon alfa-2a has shown superior safety to thrice weekly 3 million unit (MU)
      standard interferon alfa-2a for dialysis patients with chronic hepatitis C. Under the
      excellent safety profiles of treating dialysis patients with low dose pegylated interferon
      alfa-2a, we aimed to evaluate the efficacy of weekly 135 ug pegylated interferon alfa-2a for
      a total of 24 weeks for dialysis patients with acute hepatitis C, and also evaluate the SVR
      rate by retrospective chart review for dialysis patients with acute hepatitis C who did not
      receive interferon-based therapy to evaluate if early intervention for these patients will
      improve overall disease outcome.
    

Intervention name(s): Pegylated interferon alfa-2a
Intervention type(s): Drug
Intervention description(s): Pegylated interferon alfa-2a 135 ug/week for 24 weeks
Other intervention name(s): Pegylated interferon alfa-2a (Pegasys, Hoffman-La Roche)
Intervention MeSH terms: Interferons; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2a
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatitis C; Dialysis; Interferon
K-001 Treatment of Advanced Pancreatic Cancer: Clinical Trial of Monotherapy's Tolerability
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is an open and single-center Phase I clinical research on patients with advanced
      pancreatic cancer, for evaluating their adverse reactions or tolerance to K-001, so as to
      determine the safe and reasonable dosage and dosing regimen.
    

Detailed description: 
      According to past experience to toxicology studies and clinical test, K-001 at a dose of
      2700mg/day has a good safety profile for human body. Upon observation, pancreatic cancer
      patients receiving a medication at 2160mg/day (1080mg BID) have had good therapeutic
      efficacy, no sign of significant toxicity.

      Dosing regimen:

      Phase I clinical test: maximum dose of monotherapy at 2700mg/day. Four groups of repeated
      administration of monotherapy, at least 3 patients for each group.

      Group A: 2700mg/d (1350mg BID); Group B: 3240mg/d (1620mg BID); Group C: 3780mg/d (1890mg
      BID); Group D: 4320mg/d (2160mg BID). Twice a day, to be taken with warm water on an empty
      stomach; 4 weeks' administration for each group.

      In case of severe adverse reactions associated with the test drug, or if half of the
      participants show adverse reactions at Ⅲ level and above, the test should be terminated. The
      maximum dosage not causing the above-described situation shall be considered as the maximum
      tolerated dose or the biologically effective dose. After the test, continuous medication
      shall be given upon request from patients.
    

Intervention name(s): K-001
Intervention type(s): Drug
Intervention description(s): In case of severe adverse reactions associated with the test drug, or if half of the participants show adverse reactions at Ⅲ level and above, the test should be terminated. The maximum dosage not causing the above-described situation shall be considered as the maximum tolerated dose or the biologically effective dose. After the test, continuous medication shall be given upon request from patients.
Other intervention name(s): Peptidoglycan Complex of Spirulina
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Investigate How Well Ravagalimab (ABBV-323) Works and How Safe it is in Participants With Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy
Condition: Ulcerative Colitis (UC)
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 2

Summary: 
      Study M15-722 is a Phase 2a study to investigate the efficacy and safety of Ravagalimab
      (ABBV-323) in participants with moderate to severe UC who failed prior therapy.
    


Intervention name(s): Ravagalimab 600 mg; Ravagalimab 300 mg
Intervention type(s): Drug; Drug
Intervention description(s): Ravagalimab 600 mg was administered intravenously (IV).; Ravagalimab 300 mg was administered subcutaneously (SC).
Other intervention name(s): ABBV-323; ABBV-323
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ulcerative Colitis (UC); ABBV-323; Ravagalimab
MR Textural Analysis in Low Grade Gliomas
Condition: Glioma
MeSH terms: Glioma
Study type: Observational

Summary: 
      WHO classification of low grade gliomas now relies on tumoral molecular patterns, especially
      on IDH mutation and 1p/19q co deletion status. Textural analysis on medical imaging is
      studied in several fields, and could provide help in patients with brain tumor due to
      possible complications of brain biopsy. The purpose of this study is to determine if specific
      textural signature on MR imaging could be found for low grade gliomas. The investigators
      included patients with LGG diagnosed at CHU of Nice abd whose first MRI was available on the
      PACS of the CHU. Textural data are extraxted by tumoral contouring and specific logiciel
      (LifeX) and histopathologic data are assessed for each patient. Then the investigators
      analyze it to dtermine if textural indices can predict molecar status.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Lower grade gliomas diagnosed at CHU of Nice with pre operative MRI and molecular data
        available
      
Biospecimen description: 
      brain tumor surgically removed or biopsied
Investigation of Drug-drug Interaction Between Clopidogrel and Fluoxetine
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Clopidogrel is a platelet aggregation inhibitor witch prevents thrombotic events in patients
      with atherosclerotic vascular disease. To date, 4 to 30 % of patients are considered as poor,
      low or non-responder to this therapeutic. However, drug-drug interactions may lead to
      decrease the clopidogrel responsiveness. Many arguments are in support to a drug-drug
      interaction between clopidogrel and fluoxetine (selective serotonin reuptake inhibitor). On
      the pharmacokinetic level, fluoxetine inhibits the cytochroms involved in the production of
      clopidogrel active metabolite. On the pharmacodynamic level fluoxetine could increase the
      risk of hemorrhage by inhibiting the serotonin platelet reuptake and thus enhance the
      antiplatelet effect of clopidogrel.

      The purpose of this study is to investigate the influence of fluoxetine on pharmacokinetic
      and pharmacodynamic of clopidogrel.
    


Intervention name(s): Clopidogrel then fluoxetine+clopidogrel; Fluoxetine+clopidogrel then clopidogrel
Intervention type(s): Drug; Drug
Intervention description(s): D1 : clopidogrel (Plavix) 600mg (8 tablets) one time D45 to D48 : Fluoxetine (Fluoxetine EG 20mg) 20mg (1 tablet) per day D49 : 20mg Fluoxetine + 600mg Clopidogrel; D1 to D4 : Fluoxetine (Fluoxetine EG 20mg) 20mg (1 tablet) per day D5: 20mg Fluoxetine + Clopidogrel (Plavix) 600mg (8 tablets) one time D49 : Clopidogrel 600mg one time
Intervention MeSH terms: Fluoxetine; Clopidogrel
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Keywords: Healthy volunteer; Pharmacokinetic; pharmacodynamic; Polymorphism, Genetic