bioihbjkbjnl/mcl2 huggingface dataset:
Hypnosis for Chronic Idiopathic Pruritus
Condition: Chronic Idiopathic Pruritus
MeSH terms: Pruritus
Study type: Interventional

Summary: 
      Chronic idiopathic pruritus (CIP) is a frequent and disabling condition, for which there is
      no specific treatment. It was shown previously that hypnosis can relieve painful sensations.
      Pain and pruritus share many similarities regarding sensory receptors and pathways,
      suggesting that hypnosis might help relief CIP.
    

Detailed description: 
      Chronic idiopathic pruritus (CIP) is a frequent and disabling condition, with significative
      impact on quality of life. At present, there is no specific treatment for CIP. Topical
      steroids are frequently used, with partial efficacy, and adverse effects. Hypnosis is a
      specific state of conscience. It differs from waking state, sleeping state, relaxation, or
      meditation. In this state, the person is highly responsive to suggestion. In medicine,
      hypnosis can be used to engage the internal resources of the person against unpleasant
      feelings. It was shown previously that hypnosis can relieve painful sensations. Pain and
      pruritus share many similarities regarding sensory receptors and pathways, suggesting that
      hypnosis might help relief CIP.
    

Intervention name(s): Hypnosis
Intervention type(s): Other
Intervention description(s): Chronic idiopathic pruritus is treated by hypnosis
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Evaluate Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of Tripegfilgrastim in Pediatric Solid Tumor/Lymphoma Patients
Condition: Solid Tumor; Lymphoma
MeSH terms: Lymphoma
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, single ascending dose study to evaluate safety, tolerability, and
      pharmacokinetics/pharmacodynamics of Tripegfilgrastim in pediatric solid tumor/lymphoma
      patients
    


Intervention name(s): Tripegfilgrastim
Intervention type(s): Drug
Other intervention name(s): DA-3031
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Very Advanced Maternal Aged Pregnants and Early Adolescent Pregnant Women
Condition: Advanced Maternal Age Pregnancy; Early Pregnancy
Study type: Observational

Summary: 
      Maternal age is an important factor affecting the pregnancy process and its results. Adverse
      obstetric outcomes such as preterm birth, stillbirth, and infant mortality are more common in
      women older than 35 years and younger than 20 years compared to women aged 20-29. Adolescent
      pregnancies have been associated with an increased risk of adverse pregnancy outcomes such as
      preterm birth, low birth weight, perinatal death, and maternal mortality.

      Advanced maternal age pregnancies were associated with higher rates of maternal hypertension
      and diabetes, and progressively worsening perinatal outcomes such as stillbirth, preterm
      birth, and low birth weight.

      Although the investigators' region has high birth rates, as far as they have observed, the
      rates of early and advanced maternal age are also quite high. the investigators' aim in this
      study is to determine the absolute effects of early and advanced maternal age on pregnancy
      and to investigate the pregnancy outcomes of these mothers.
    

Detailed description: 
      The investigators' aim in this study is to determine the absolute effects of early and
      advanced maternal age on pregnancy and to investigate the pregnancy outcomes of these
      mothers. For this purpose, the information of 90 pregnant women followed in Siirt Training
      and Research Hospital between 2017-2021 will be accessed through the hospital's data system.
      Maternal age, pregnancy history, Assisted reproductive technologies history, laboratory
      findings, screening test results, mode of delivery, baby birth information, pregnancy
      complications and complications during delivery will be recorded. In the light of the
      information gathered, the rates of negative effects of gestational age on pregnancy will be
      calculated.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Pregnant on the age of 16 and below and on the age of 45 and above, control groups
      
Keywords: age; pregnancy; adolescent; perinatal; neonatal
Directional Deep Brain Stimulation With Patients With Advanced Parkinson's Disease
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Observational [Patient Registry]

Summary: 
      The aim of the study is to assess the clinical outcome in patients with Parkinson's disease
      treated with directional deep brain stimulation (dDBS). The patients have been selected for
      the dDBS treatment by their treating neurologist. The study is a registry-based follow-up
      study.
    

Detailed description: 
      The study group consists of patients with advanced Parkinson's disease treated with
      directional deep brain stimulation in Helsinki University Hospital between 2017 - 2020. The
      study is a registry-based follow-up study. The aim of the study is to assess the clinical
      outcome and possible adverse effects of the dDBS treatment. The data will be collected from
      the patient records. The observed time points are 6-month's, 12-month's and 18-month's
      postoperative visits.

      The following data will collected: the scores of Unified Parkinson's disease questionnaire
      part III (UPDRS-III), Non-Motor Symptoms Questionnaire (NMS-quest), Beck Depression Inventory
      (BDI), Mini-Mental State Examination (MMSE), Abnormal Involuntary Movement Scale (AIMS)
      evaluated in the screening phase for dDBS treatment and at 6-months' follow-up. Possible
      levodopa equivalent dose changes, LEDDs, will also be assessed at these time points.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Study population will consist of the initial 63 patients with Parkinson'd disease treated
        with directional deep brain stimulation in Helsinki University Hospital
      
Keywords: deep brain stimulation; advanced Parkinson's disease; DBS; dDBS
Post-natal Depression and Chronic Stress
Condition: Depression, Postpartum
MeSH terms: Depression, Postpartum; Depression; Depressive Disorder
Study type: Observational

Summary: 
      The risk of emergence of a post natal depression is based on an interaction between a
      maternal psychic vulnerability and a chronic environmental context of stress. The PND appears
      as a relevant model for studying the mechanisms of chronic stress and vulnerability to
      psychological pathologies.

      This study aim to follow a cohort of pregnant women to determine the predictive
      psychobiological factors of the emergence of postnatal depression
    

Detailed description: 
      The prevalence of postnatal depression is high in civilian settings (20%). In mechanistic
      terms, the risk of emergence of a post natal depression is based on an interaction between a
      maternal psychic vulnerability and a chronic environmental context of stress. The post natal
      depression appears as a relevant model for studying the mechanisms of chronic stress and
      vulnerability to psychological pathologies.

        -  On the one hand, the repetition of stressors during pregnancy corresponds to a natural
           chronic stress model of several months and thus allows to study the biological cost of
           responses to repeated stresses, and the adaptive mechanisms leading to From functional
           drift to psychic dysfunction.

        -  On the other hand, isolated vulnerability factors characterize a mirroring psychological
           profile of a Mindfulness type of functioning. Mindfulness or full consciousness has been
           described as a state of consciousness which results from intentionally, at the present
           moment, without judging the experience that unfolds moment by moment. This psychological
           resource has been associated with resilient or even resilient psychic functioning.

      This study aim to follow a cohort of pregnant women from the first trimester of pregnancies
      to 2 months after the delivery to determine the predictive psychobiological factors of the
      emergence of postnatal depression
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        WOMEN DURING EARLY PREGNANCY
      
Keywords: postnatal depression stress mindfulness allostatic load
A Phase I Randomized, Observer-Blinded, Dose-Ranging Study in Healthy Subjects 24 to <72 Months of Age
Condition: Respiratory Synctial Virus
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, observer-blind, irrelevant comparator-controlled trial in male and
      female subjects ≥24 months of age and <72 months of age. Subjects will be without symptomatic
      chronic cardiopulmonary disease, including recurrent wheezing. Subjects will be screened for
      seropositivity to RSV in a qualified serum microneutralization (MN) assay and will be
      excluded if titers for either RSV/A or RSV/B are <1:16 (4 log2).

      Treatments will comprise an IM dose of saline placebo or RSV F vaccine on Day 0 and an IM
      dose of RSV F vaccine or a licensed hepatitis A vaccine on Day 28. Hepatitis A vaccine (and
      in one group placebo) will be used to maintain the study blind; all subjects will receive a
      complete course of hepatitis A vaccine as a study benefit.
    


Intervention name(s): RSV F Vaccine with adjuvant (0.5mL injection); RSV F Vaccine (0.5mL injection); Hepatitis A Vaccine (0.5mL injection); Placebo (0.5mL injection)
Intervention type(s): Biological; Biological; Biological; Biological
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Tamsulosin Phase III Clinical Trial -Double-Blind, Placebo Controlled Study in Female Patients With Lower Urinary Tract Syndrome
Condition: Urinary Tract Diseases
MeSH terms: Urologic Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether Tamuslosin is effective in the treatment of
      lower urinary tract syndrome with female patients.
    


Intervention name(s): Tamuslosin
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: tamsulosin; urinary tract diseases; female
Intermittent Preventive Treatment of Malaria in Schoolchildren
Condition: Malaria; Intermittent Preventive Treatment
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 3

Summary: 
      This will be a randomized, single-blinded, placebo-controlled trial to evaluate the efficacy,
      safety and tolerability of antimalarial regimens in healthy schoolchildren. The primary
      objective of the study is to compare the efficacy of different combination antimalarial
      regimens, including amodiaquine + sulfadoxine-pyrimethamine (AQ+SP),
      dihydroartemisinin-piperaquine (DP), and placebo, to SP for intermittent preventive treatment
      (IPT) in schoolchildren, as measured by risk of parasitaemia (unadjusted by genotyping) after
      42 days of follow-up. This will assess both the efficacy for treatment of asymptomatic
      infections and the efficacy for prevention of new infections.
    

Detailed description: 
      The study will be carried out among children aged ≥ 8 to < 14 years (boys) and ≥ 8 to < 12
      years (girls) attending primary schools in Tororo district. Schools will be selected using
      convenience sampling with the assistance of the district and the education sector. The target
      population includes children attending primary schools in Uganda. The accessible population
      includes the children attending the participating primary schools in classes 3-7 in Tororo
      district. Children who meet the selection criteria for participation in the study will be
      randomized to treatment with one of the four study regimens and will be followed for 42 days.
      Repeat evaluations will be performed on days 1, 2, 3, 7, 14, 28, and 42 (and any unscheduled
      day that a student is ill) and will include assessment for the occurrence of adverse events.
      Treatment efficacy outcomes will be assessed using revised WHO outcome classification
      criteria. Acceptability of treatment regimens will be assessed using a questionnaire
      administered to participating students on day 7. The primary outcome measure is risk of
      parasitaemia (unadjusted by genotyping) after 42 days of follow-up.
    

Intervention name(s): sulfadoxine-pyrimethamine; amodiaquine + sulfadoxine-pyrimethamine; dihydroartemisinin-piperaquine; Placebo
Intervention type(s): Drug; Drug; Drug; Other
Intervention description(s): 25 mg/kg po once on day 0; Amodiaquine: 10 mg/kg po daily for 3 days (on days 0, 1, 2) SP: 25 mg/kg po once on day 0; 2.1/17.1 mg/kg daily for three days (on days 0, 1, 2); dosed as for amodiaquine (10mg/kg po daily on days 1, 2)
Other intervention name(s): Fansidar, Roche; Camoquin, Pfizer; Fansidar, Roche; Duocotexcin, Holley Cotec Pharmaceuticals; No active ingredient
Intervention MeSH terms: Pyrimethamine; Piperaquine; Sulfadoxine; Fanasil, pyrimethamine drug combination; Amodiaquine; Artenimol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Malaria; Intermittent preventive treatment; Efficacy; Safety; Tolerability; Schoolchildren; Uganda
Effect of Amlodipine Versus Bisoprolol on Hypertensive Patients With End-stage Renal Disease on Maintenance Hemodialysis.
Condition: Hypertension, Renal
MeSH terms: Kidney Failure, Chronic; Hypertension, Renal
Study type: Interventional
Phase: Phase 4

Summary: 
      Hypertension is highly prevalent in hemodialysis (HD) patients and leads to increased
      morbidity and mortality due to cardiovascular disease(CVD). Left ventricular hypertrophy
      (LVH) is both a manifestation of hypertension caused end-organ damage and an independent risk
      factor for CVD. Evidence shows that Beta-blockers, especially of low dialyzability decrease
      risk of CVD and mortality. Calcium channel blockers (CCBs) were also shown to effectively
      control BP in the volume expanded state and reduce cardiovascular disease risk. Asymmetric
      dimethyl arginine (ADMA) is a uremic toxin that decreases NO synthesis and is correlated to
      LVH, carotid intimal thickness (CIT), CVD, and mortality. Amlodipine is shown in one study to
      significantly reduce ADMA level in HD patients. The purpose of this study is to determine the
      effect of calcium channel blocker Amlodipine compared to Beta-blocker Bisoprolol on
      regression of LVH, reduction of ADMA plasma level and on BP control among hypertensive
      patients on HD.
    


Intervention name(s): Bisoprolol Fumarate 5-10 mg; Amlodipine 5-10 mg
Intervention type(s): Drug; Drug
Intervention description(s): Bisoprolol as antihypertensive drug in patients on hemodialysis; Amlodipine as antihypertensive drug in patients on hemodialysis
Intervention MeSH terms: Amlodipine; Bisoprolol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Antioxidant Effect of Aged Garlic Extract
Condition: Heavy Smoker or Non-smoker
Study type: Interventional

Summary: 
      This is a randomized, double-blind, placebo controlled, crossover study to determine the
      antioxidant effect of aged garlic extract. This study will also compare the oxidative status
      in heavy smokers with that in non-smokers.
    


Intervention name(s): Placebo; Aged garlic extract
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Study to Assess the Effect of Macitentan on the Electrocardiogram (ECG) in Healthy Male and Female Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is intended to demonstrate that macitentan does not have an effect on cardiac
      repolarization exceeding the threshold of regulatory concern after repeated administration of
      daily oral doses of 10 and 30 mg to healthy male and female subjects.
    


Intervention name(s): Moxifloxacin 400 mg; Macitentan 10 mg; Macitentan 30 mg; Placebo
Intervention type(s): Drug; Drug; Drug; Other
Other intervention name(s): Opsumit; Opsumit
Intervention MeSH terms: Moxifloxacin; Macitentan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Keywords: Macitentan; Pharmacokinetics; Pharmacodynamics
VA111913 Dysmenorrhoea Efficacy and Safety Proof of Concept
Condition: Primary Dysmenorrhea
MeSH terms: Dysmenorrhea
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to investigate how effective VA111913 is at preventing menstrual
      pain in women with primary dysmenorrhoea.
    

Detailed description: 
      Dysmenorrhoea is suffered by between 50% and 90% of women of child bearing age. Up to 30% of
      these women are non-responsive to the currently prescribed therapies. As such it represents
      an area of unmet medical need. VA111913 inhibits vasopressin-induced contractions of human
      myometrial strips and human myometrial blood vessels in vitro. By this mechanism, it is
      anticipated that the pain of dysmenorrhoea, a condition in which myometrial tone and
      contractions are increased and blood flow to the uterus is decreased compared to normal, may
      be reduced.

      Subjects will be dosed with VA111913 TS and placebo in a cross over design during two
      consecutive menstrual cycles. They will be dosed for up to a maximum of 6 days, beginning 2
      days before the onset of menstruation. Subjects will then assess the menstrual pain, bleeding
      and amount of analgesia required to treat symptoms during each cycle
    

Intervention name(s): VA111913 TS and placebo
Intervention type(s): Drug
Intervention description(s): VA111913 TS twice daily for a maximum of 6 days during one menstrual cycle followed by placebo twice daily for up to a maximum of 6 days during a second menstrual cycle in a cross over design
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: dysmenorrhoea; dysmenorrhea; pain; pre-emptive
Investigation of H01 in Adults With Pulmonary Hypertension Including Interstitial Lung Disease (The SATURN Study).
Condition: Pulmonary Hypertension
MeSH terms: Lung Diseases; Hypertension, Pulmonary; Lung Diseases, Interstitial; Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is a prospective, randomized, double-blind, study of H01 (Hymecromone) in adults
      with pulmonary hypertension (PH). The primary objective of this study is to evaluate the
      safety and tolerability of oral H01 and the potential benefit of oral H01 on clinical
      measures of PH disease severity over 24 weeks.

      Study Hypothesis:

      Oral H01, at doses of 1600 mg per day, will be a safe and well-tolerated agent in adults with
      pulmonary hypertension over 24 weeks
    

Detailed description: 
      The study's objectives are to evaluate:

        -  The changes in clinical and functional measures (pulmonary function test, pulmonary
           vascular resistance, mean pulmonary arterial pressure, and 6 Minute Walk Distance Test)
           in adults with PH treated with oral H01

        -  The safety and tolerability of the use of oral H01 for PH over 24 weeks using health
           criteria/evaluations (Common Terminology Criteria for Adverse Events (CTCAE), quality of
           life (QOL) score, EMPHASIS-10 score and St George Respiratory Questionnaire (SGRQ)
           score)

        -  To investigate the clinical efficacy, pharmacokinetic (PK) and pharmacodynamic (PD)
           markers (serum HA concentration, inflammatory markers and cytokines, NT-proBNP, and H01
           and metabolite serum concentrations) in this population following oral H01 use
    

Intervention name(s): Hymecromone (H01); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 800 mg oral H01 two times a day (total dose: 1600 mg/day).; Oral tablet placebo (inactive ingredients) two times a day.
Other intervention name(s): Cantabiline; Isochol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Six Minute Walk Distance Test (6 MWDT); Right Heart Catheterization (RHC); Pulmonary Vascular Resistance (PVR); Pulmonary Function Test (PFT); Mean Pulmonary Arterial Pressure (mPAP); Pharmacokinetics; Pharmacodynamics; Hyaluronan; Hymecromone
Digital Technique to Analyze the Wear of Implants and Natural Tooth as Antagonist.
Condition: Dental Prosthesis Failure
MeSH terms: Mouth, Edentulous; Prosthesis Failure
Study type: Interventional

Summary: 
      The aim of this study was to describe a novel digital technique to analyze the wear of
      screw-retained implant-supported metal-ceramic dental prostheses and natural tooth as
      antagonist. Materials and methods: Ten patients were consecutively included to rehabilitate
      partial edentulism by dental implants. Both the screw-retained implant-supported
      metal-ceramic dental prostheses and the natural tooth as antagonist were submitted to a
      digital impression through an intraoral scan to generate a Standard Tessellation Language
      digital file preoperatively (STL1), at 3 months (STL2), and 6 months (STL3) follow-up.
      Afterwards, an alignment procedure of the digital files (STL1-STL3) was performed on a
      reverse engineering morphometric software and volume changes at the screw-retained
      implant-supported metal-ceramic dental prostheses and the natural tooth as antagonist were
      analyzed using Student's t-test. Moreover, Gage R&R statistical analysis was conducted to
      analyze the repeatability and reproducibility of the digital technique.
    


Intervention name(s): The wear of screw-retained implant-supported metal-ceramic dental prostheses and natural tooth
Intervention type(s): Procedure
Intervention description(s): A novel digital technique to analyze the wear of screw-retained implant-supported metal-ceramic dental prostheses and natural tooth as antagonist
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Implant supported; morphometry; screw-retained; digital; wear