bioihbjkbjnl/mcl2 huggingface dataset:
A Study of LY3561774 in Participants With Dyslipidemia
Condition: Dyslipidemias
MeSH terms: Dyslipidemias
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a 3-part study. In Parts A and B, the main purpose is to evaluate the safety and
      tolerability of the study drug known as LY3561774 in participants with dyslipidemia (high
      blood fat levels). How the body processes the study drug and the effect of the study drug on
      blood fat levels will also be investigated. Part C will mainly evaluate the safety and
      tolerability of LY3561774 as well as how the body processes the study drug in Japanese
      participants. The study may last up 52, 56 and 28 weeks for each participant in Parts A, B
      and C, respectively. There are up to 22, 26 and 16 visits in Parts A, B and C, respectively.
    


Intervention name(s): LY3561774; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered SC.; Administered SC.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Prevention of Postpartum Haemorrhage With Sublingual Misoprostol or Oxytocin
Condition: Postpartum Hemorrhage
MeSH terms: Postpartum Hemorrhage; Hemorrhage
Study type: Interventional
Phase: Phase 3

Summary: 
      Sublingual misoprostol produces rapid peak concentration and is more effective than oral
      misoprostol for prevention of excessive postpartum bleeding. The study hypothesis was to test
      whether women receiving sublingual misoprostol for prevention of postpartum hemorrhage have
      30 ml less average blood loss than women receiving oxytocin, the standard of care for
      prevention of postpartum hemorrhage. We conducted a Double blind randomized controlled trial
      of .652 consenting, eligible pregnant women admitted to the labor room of the teaching
      hospital at J N Medical College, Belgaum, India. Women participating in the study were
      assigned by computer generated randomization to receive the study medications and placebos
      within one minute after clamping and cutting the umbilical cord. We also looked at the drugs
      effects on postpartum blood loss at or above ≥500 ml (considered hemorrhage), and the percent
      of women experiencing more than a 10% decline in haemoglobin, and reported drug side effects.
    


Intervention name(s): Misoprostol; Oxytocin
Intervention type(s): Drug; Drug
Intervention description(s): 400 µg sublingual misoprostol; 10 IU IM
Intervention MeSH terms: Misoprostol; Oxytocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Keywords: Misoprostol, oxytocin, postpartum blood loss, hemoglobin
Uncontrolled, Open Label, Pilot and Feasibility Study of Niacinamide in Polycystic Kidney Disease
Condition: Polycystic Kidney Disease
MeSH terms: Kidney Diseases; Polycystic Kidney Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      The goal of this pilot study is to evaluate the feasibility of administering niacinamide to
      patients with autosomal dominant polycystic kidney disease, to develop methods to assess the
      biological efficacy of niacinamide, and to perform a preliminary exploration of its clinical
      effect on kidney cyst growth and kidney function.
    

Detailed description: 
      Niacinamide is a form of vitamin B3. Vitamin B3 is found in many foods including yeast, meat,
      fish, milk, eggs, green vegetables, beans, and cereal grains. Recent studies in mice have
      shown that niacinamide, at high doses, may slow kidney cyst growth from polycystic kidney
      disease (PKD).

      By doing this study, the researchers will determine if a larger, long-term study to test
      whether niacinamide slows progression of PKD is justified.
    

Intervention name(s): Niacinamide
Intervention type(s): Dietary Supplement
Other intervention name(s): Vitamin B3
Intervention MeSH terms: Niacinamide; Niacin; Nicotinic Acids
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PKD; niacinamide; Vitamin B3; Vitamin B
Clinical and Genetic Influencing Factors on Clozapine Pharmacokinetics
Condition: CYP1A2 Polymorphism; CYP2C19 Polymorphism; Clozapine; Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      Clozapine (Clz), an atypical antipsychotic, is the reference medication for patients with
      treatment-resistant schizophrenia. Due to the high inter-individual variability of its
      pharmacokinetics and its narrow therapeutic index, a close therapeutic drug monitoring (TDM)
      of Clz is highly recommended.

      Several factors can cause a variation in the pharmacokinetics as age, smoking habits, coffee
      consumption and drug interaction. Genetic factors related to hepatic expression levels of the
      cytochrome P450 (CYP), regulate the hepatic clearance of Clz, thereby determine its
      bioavailability.

      The CYP1A2 and CYP2C19 isoenzymes are mainly responsible for the metabolism of several drugs
      including Clz. It has been demonstrated that there is an interethnic variation in the
      expression and function of these two isoenzymes. This variation is caused by single
      nucleotide polymorphisms (SNPs) of genes encoding these proteins.

      While the Influence of the different polymorphisms related to CYP1A2 and CYP2C19 have been
      established especially in Asian and Caucasian populations, no study has examined the impact
      of these SNPs in the southern Mediterranean populations. Moreover, the impact of these SNPs
      is very controversial. The present study aims to investigate in Tunisian schizophrenic
      patients, the influence of genetic (CYP1A2 and CYP2C19 polymorphisms) and non-genetic factors
      on Clz pharmacokinetics.
    


Intervention name(s): Determination of plasma concentration of clozapine/ Genotyping
Intervention type(s): Other
Intervention description(s): Determination of trough plasma concentration of clozapine (C0) Genotyping of CYP1A2 & CYP2C19
Intervention MeSH terms: Clozapine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
US Guided Erector Spinae Plane Block in Breast Cancer Surgery: Analgesia, Spread and Immunomodulation
Condition: Analgesia; Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      Prospective interventional study
    

Detailed description: 
      The aim of the present study is to evaluate the effect of US guided unilateral ESPB using
      different volumes of local anaesthetics on analgesic efficacy, dermatomal spread and
      immunomodulation in breast cancer surgery.

      The primary outcome is the analgesic efficacy of the different local anaesthetic volumes of
      ESPB.

      The secondary outcomes are the dermatomal dye spread and sensory coverage, immunomodulation
      and complications in breast cancer surgery.

      Immunomodulation will be assessed by measuring Natural killer cells cytotoxicity.
    

Intervention name(s): Erector Spinae Plane Block with Bubivacaine; Standard General Anaesthesia
Intervention type(s): Procedure; Procedure
Intervention description(s): Erector Spinae Plane Block with Bubivacaine 0.25% or 0.125% before breast cancer surgery; Standard General Anaesthesia without ESPB
Intervention MeSH terms: Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Erector spinae plane block; Ultrasound guided; Breast cancer surgery; Natural killer cells; Analgesia; spread
Counseling of Pregnant Women During Corona
Condition: Respiratory Tract Infections
MeSH terms: Infections; Respiratory Tract Infections
Study type: Interventional

Summary: 
      Corona virus is known as covid 19 And is transmitted through droplet infection
    

Detailed description: 
      Symptoms of Corona include cough Fever and dyspnea
    

Intervention name(s): Women receiving extra remembering by healthcare
Intervention type(s): Other
Intervention description(s): Women receiving extra remembering by healthcare in covid infection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
FOLFOX-4 3months Versus 6 Months and Bevacizumab as Adjuvant Therapy for Patients With Stage II/III Colon Cancer
Condition: Colon Cancer
MeSH terms: Colonic Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      This project consists of two independent, following specific eligibility criteria and
      different randomisation schemes studies, later on called DURATION study and BEV study. Once
      randomised in the duration study, patients fulfilling eligibility criteria for BEV study may
      also be randomized to receive BEV or no BEV, in addition to FOLFOX-4 chemotherapy.

      As both are open label studies, there will be no blinding of treatment assignment.
    

Detailed description: 
      At the present time the standard treatment for resected colon cancer with high possibility of
      relapse ("high risk" stage II and all stage III) is represented by the regimen FOLFOX
      (leucovorin, bolus and infusional 5fluorouracil and oxaliplatin), which is able to increase
      significantly the disease-free survival (DFS) at 3 and 4 years, whereas the advantage for
      5-year overall survival (OS) (which is predicted by the previous parameter) could be observed
      only with a further increase of follow-up. The conventional duration of chemotherapy is today
      of 6 months (12 courses every 2 weeks), but this long drug exposure increases the risk of
      long-term neurotoxicity. A reduction of adjuvant chemotherapy under 6 months was proven
      effective in other cancers (breast, testis…) and is better tolerated by patients in clinical
      practice. On the other hand, bevacizumab significantly increases OS and all other parameters
      when combined with standard chemotherapy in advanced disease.
    

Intervention name(s): FOLFOX (Oxaliplatin, 5Fluorouracil, Lederfolin); FOLFOX (Oxaliplatin, 5Fluorouracil, Lederfolin)
Intervention type(s): Drug; Drug
Intervention description(s): To assess whether a 3-month FOLFOX-4 treatment is at least equivalent to a 6-month FOLFOX-4 treatment; standard treatment
Other intervention name(s): FOLFOX 3 vs 6; FOLFOX 3 vs 6
Intervention MeSH terms: Leucovorin; Fluorouracil; Oxaliplatin; Levoleucovorin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: colorectal neoplasm; high risk; stage II/III
Sustainable Efficacy of Vardenafil OD Versus Vardenafil PRN in Erectile Dysfunction
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Study type: Interventional
Phase: Phase 2

Summary: 
      Compare once daily vs on demand treatment in men with erectile dysfunction.

      Treatment of mild to moderate erectile dysfunction with 10 mg vardenafil p.o. over 24 weeks +
      4 weeks wash-out:

      A: once daily at bedtime for 12 weeks followed by 12 weeks of placebo B: once daily at
      bedtime for 24 weeksC: PRN for 24 weeks
    


Intervention name(s): Levitra (Vardenafil, BAY38-9456); Levitra (Vardenafil, BAY38-9456)
Intervention type(s): Drug; Drug
Intervention description(s): Vardenafil 10 mg on demand use; Vardenafil daily dosing 10 mg
Intervention MeSH terms: Vardenafil Dihydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Erectile dysfunction; Vardenafil
Risk Factors of Hypertensive Urgencies
Condition: Hypertensive Urgency
Study type: Observational

Summary: 
      The purpose of this study is to determine whether frequent hypertensive urgencies increase
      the risk of cardiovascular events in patients with arterial hypertension.
    

Detailed description: 
      The spectrum of disorders associated with arterial hypertension (AH) encompasses chronic
      uncomplicated hypertension and the hypertensive crises, including hypertensive urgences and
      emergencies. Hypertensive crises accounted for more than 25% of all patient visits to a
      medical section of an emergency department, with hypertensive urgences (HU) accounting for
      two-third of these cases. Hypertensive crises, without prompt treatment, are often associated
      with morbidity and mortality. We propose to conduct a population-based case-control study of
      HU in areas of the Russian Federation. We will include about thirty study centers and one
      data coordinating center and will recruit study participants over a period of one years. We
      plan to conduct in-person interviews with 1,500 cases and 1,500 controls to elicit
      information on demographic background and history of exposures. We intend to test about 20-25
      risk factors of HU thus calculated target number of subject is 3000 pts. We're going to get
      access to hospital lists in each study center. From the database we'll select patients with
      AH and recruit every third participant who came to hospital or/and policlinic. Every selected
      participant will be asked to respond to some questions by phone and be divided into two
      groups. Participants who have HU two weeks before the call will be questioned about level of
      arterial pressure and treatment during HU. Participants with often HU (every week or more)
      will be included into first group (prevalent cases, group A). Participants with seldom HU
      (every month or less) will be included into second group (controls, group B). Cases and
      controls will be selected from the same population of AH patients. Questionnaire contains
      information about age, gender, tobacco use, data about HU (frequency, treatment and its
      complications), antihypertensive and concomitant treatment, level of blood pressure,
      regularity of taking antihypertensive drugs, associated clinical conditions (cerebrovascular
      disease, heart disease, renal disease, peripheral vascular disease), PCI, CABG, if it be
      possible we intend to collect information of factors influencing prognosis (fasting plasma
      glucose, dyslipidaemia, serum creatinine, serum uric acid, left ventricular hypertrophy).
    

Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Participants will be selected from hospital/policlinic database by random telephone dialing
        to every third patient who are diagnosed with arterial hypertension (SBP/DBP>140/90 Hg or
        taking antihypertensive drugs)
      
Keywords: hypertensive urgency; arterial hypertension
Randomized Study of New Formulation Ophthalmic Cysteamine Hydrochloride for Corneal Cystine Accumulation in Patients With Cystinosis
Condition: Cystinosis
MeSH terms: Cystinosis
Study type: Interventional

Summary: 
      OBJECTIVES: I. Determine the proportion of patients with cystinosis who experience a serious
      adverse effect when treated with a new formulation of cysteamine hydrochloride for corneal
      cystine accumulation.

      II. Determine the proportion of patients with a reduction in corneal crystal density of 1.00
      unit when treated with this regimen.
    

Detailed description: 
      PROTOCOL OUTLINE: This is a randomized, multicenter study Patients are randomized to receive
      the current formulation of cysteamine hydrochloride as drops in one eye and the new
      formulation of cysteamine hydrochloride as drops in the other eye.

      Patients receive the two formulations of cysteamine hydrochloride in their assigned eyes
      every hour during waking hours daily for 6 months (safety study) or for 1 year (efficacy
      study).
    

Intervention name(s): cysteamine hydrochloride
Intervention type(s): Drug
Intervention MeSH terms: Cysteamine
Primary purpose: Treatment
Keywords: cystinosis; rare disease; renal and genitourinary disorders
Fish Oil and Cardiovascular Suboptimal Health
Condition: Suboptimal Health Status
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether omega-3 fatty acids supplementation are
      effective in the improvement of suboptimal health status and cardiovascular risk.
    

Detailed description: 
      The Suboptimal health status questionnaire (SHSQ-25) is used to evaluate the suboptimal
      health status. The SHSQ-25 includes 25 questions. The score of the SHSQ-25 is from 0 to 100.
      Suboptimal health status is defined as the SHSQ-25 score above than 35. The higher scores of
      the SHSQ-25 one gets, the more severity of suboptimal health status he/she has. All
      participants are asked to fill in the SHSQ-25 before and after the intervention. If the score
      decreases after the intervention, it means that the suboptimal health status has been
      improved.
    

Intervention name(s): Omega -3 fatty acids; Placebo: Corn oil
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Each subject assigned to active treatment group will receive 4 g/day capsule of omega-3 fatty acids.; Each subject assigned to the control group will receive 4 g/day capsule of corn oil.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Progressive Resistance Exercise in Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 4

Summary: 
      A randomized controlled trial with rheumatoid arthritis patients will be realized. Patients
      will be randomized into two groups. Experimental group will do a 12 weeks training of
      progressive resistance exercise for global muscles and remain with the clinical treatment and
      the control only remain with the clinical treatment. Patients will be evaluated at baseline,
      after 6, 12 and 24 weeks.
    


Intervention name(s): Control group; Experimental group
Intervention type(s): Other; Other
Other intervention name(s): Clinical tretament
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Rheumatoid arthritis; Progressive resistance exercise; Pain; Functional capacity; Quality of life; Muscle strength
Monoclonal Antibody Followed by Bone Marrow Transplantation in Treating Patients With Acute Myelogenous Leukemia in Remission or First Relapse
Condition: Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver
      cancer-killing substances to them without harming normal cells. Monoclonal antibody combined
      with a radioactive substance and given prior to bone marrow transplantation may kill more
      cancer cells.

      PURPOSE: Phase II trial to study the effectiveness of radiolabeled monoclonal antibody given
      prior to bone marrow transplantation in treating patients with acute myelogenous leukemia.
    

Detailed description: 
      OBJECTIVES: I. Determine the overall and disease-free survival and toxicity associated with
      busulfan/cyclophosphamide (BU/CTX) plus 131I-labeled BC8 antibody (131I-BC8) followed by an
      HLA-identical related marrow transplant in patients with acute myelogenous leukemia in first
      or second remission or untreated first relapse. II. Study factors that may influence the
      biodistribution of 131I-BC8 in this patient population, including marrow cellularity, the
      level of antigen expression by leukemic cells (in relapsed patients), and the degree of
      antigen saturation by antibody. III. Determine the efficacy of BU/CTX in patients in first
      remission unable to receive radiolabeled antibody, e.g., patients who are HAMA-positive,
      those not tolerating antibody test infusion, those with unfavorable antibody biodistribution,
      or those for whom antibody is unavailable.

      OUTLINE: Radioimmunotherapy plus 2-Drug Cytoreductive Chemotherapy followed by Bone Marrow
      Transplantation with, as indicated, CNS Therapy. Iodine-131-labeled Monoclonal Antibody BC8
      (anti-CD45), 131I-BC8; plus Busulfan, BU, NSC-750; Cyclophosphamide, CTX, NSC-26271; followed
      by Allogeneic Bone Marrow, ABM; with, as indicated, Intrathecal Methotrexate, IT MTX,
      NSC-740.

      PROJECTED ACCRUAL: It is anticipated that 30 patients in first remission, 30 patients in
      untreated first relapse, and 15 patients in second remission will be accrued over 3 years.
    

Intervention name(s): busulfan; cyclophosphamide; methotrexate; allogeneic bone marrow transplantation; radioimmunotherapy
Intervention type(s): Drug; Drug; Drug; Procedure; Radiation
Intervention MeSH terms: Cyclophosphamide; Busulfan; Methotrexate
Primary purpose: Treatment
Keywords: recurrent adult acute myeloid leukemia; adult acute myeloid leukemia in remission
Clinical Evaluation of Safety and Efficacy of Radio Frequency (Forma Eye) Treatment for Dry Eye Disease Due to Meibomian Gland Dysfunction
Condition: Improvement of Dry Eye Disease
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases; Meibomian Gland Dysfunction
Study type: Interventional

Summary: 
      The aim of the study is to evaluate the safety and efficacy of radiofrequency treatment for
      dry eye disease due to meibomian gland dysfunction
    


Intervention name(s): Forma Eye Applicator
Intervention type(s): Device
Intervention description(s): Eligible subjects will receive up to 3 treatments (2-3 weeks interval) with the Forma Eye Applicator according to the study protocol.
The subject will return for 3 follow up visits: four weeks (4wk FU), 12 weeks (12wk FU), twenty-four weeks (24wk FU) after the last treatment.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment