bioihbjkbjnl/mcl2 huggingface dataset:
Surgical Management of Postpartum Haemorrhage Without Embolization
Condition: Postpartum Hemorrhage; Second Line Management; Uterine Arteries Embolization; Surgical Management of Haemorrhage
MeSH terms: Postpartum Hemorrhage; Hemorrhage
Study type: Observational

Summary: 
      Postpartum haemorrhage is the main cause of maternal mortality. The aim of investigators'
      study was to evaluate the practice of hemostatic surgery (arterial ligation, uterine
      compression or hysterectomy) when the embolization of uterine arteries wasn't be performed.
    


Intervention name(s): Arterial embolization and/or surgical management.
Intervention type(s): Other
Intervention description(s): Arterial embolization and/or surgical management.
Observational model: Other
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Patients with postpartum haemorrhage with a surgical management in a type III universitary
        maternity.
      
Keywords: Embolization; surgery; hysterectomy; arterial ligation
Aerosol Cyclosporine in Chronic Obstructive Pulmonary Disease (COPD)
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, double-blinded, Phase I dose escalation-deescalation protocol (DEP) of
      cyclosporine inhalation solution in patients with Gold Stage III chronic obstructive
      pulmonary disease.

      The purpose of the study is to evaluate the safety and effectiveness of aerosolized
      Cyclosporine in treating COPD.

      The specific aims of the study are:

        1. To identify the short term (28 day) safety profile of CyIS immunotherapy in severe COPD
           (GOLD III) patients with particular attention to airway reactivity and infection risk.

        2. To identify the pharmacokinetic-pharmacodynamic relationship of CyIS using peripheral
           blood markers of an adaptive immune response as endpoints in subjects with severe COPD
           (GOLD III) treated short-term.

      Subjects between 45 and 70 years of age with a confirmed diagnosis of COPD, Gold Stage III,
      and meet all the study requirements, will be enrolled in this study. A total of 24 subjects
      of either sex will be enrolled in this study. A total of 4 subject cohorts (n=6) will
      participate in the protocol.
    


Intervention name(s): Cyclosporine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Cyclosporine Inhalation Solution, Once Daily
Intervention MeSH terms: Cyclosporine; Cyclosporins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Gold Stage III COPD
A Study to Assess the Pharmacokinetics of AZD4831 When Administered Alone and in Combination With Itraconazole
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      A study to demonstrate pharmacokinetics of AZD4831 when administered alone and in combination
      with Itraconazole.
    

Detailed description: 
      This will be a an open-label, 3-period fixed sequence study to be conducted at a single study
      centre.

      The treatment starts with AZD4831 (Treatment Period 1), followed by Itraconazole
      administration for 3 days (Treatment Period 2) and finally a combination of
      AZD4831+Itraconazole administration (Treatment Period 3).

      The study will comprise of:

        -  A Screening Period of approximately 28 days.

        -  Three Treatment Periods:

             -  Treatment Period 1 (Day -1 through pre-dose Day 8): Single oral dose of AZD4831
                only on Day 1,

             -  Treatment Period 2 (Day 8 through pre-dose Day 11): Oral dose of Itraconazole only
                on Days 8 through 10,

             -  Treatment Period 3 (Day 11 through Day 18, after the last PK sample is collected):
                AZD4831 and Itraconazole on Day 11 and oral dosing of Itraconazole only on Days 12
                through 17.

        -  A final Follow-up Visit after the last PK sample (Day 25 to Day 32).

      Each subject will be involved in the study for approximately 9 weeks (including the 28 day
      Screening Period).
    

Intervention name(s): AZD4831; Itraconazole
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will receive single oral dose only on Day 1 and Day 11.; Subjects will receive Itraconazole orally on Days 8 followed by dosing from Day 9 to Day 17.
Intervention MeSH terms: Itraconazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Fixed Sequence Study; Cardiovascular Disease; Drug-drug interaction; Pharmacokinetics; Myeloperoxidase inhibitor
Effect of Short-term Oxygen During CPET in Pulmonary Hypertension
Condition: Pulmonary Arterial and Chronic Thromboembolic Pulmonary Hypertension; Chronic Cardiorespiratory Disease
MeSH terms: Hypertension, Pulmonary; Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      In a randomized, sham-controlled trial the investigators will test whether supplemental
      oxygen given during cardiopulmonary exercise testing will improve exercise performance and
      physiological parameters in patients with pulmonary arterial or chronic thromboembolic
      pulmonary hypertension.
    


Intervention name(s): Supplemental oxygen via a mask
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Tobramycin-Dexamethasone Versus Tobramycin-Dexamethasone Plus Ketorolac After Phacoemulsification Surgery
Condition: Cataract
MeSH terms: Cataract
Study type: Interventional

Summary: 
      This randomized controlled trial compares two regimens of topical therapy:

        -  tobramycin 0.3% - dexamethasone 0.1% (TobraDex®, Alcon), one drop four times/day

        -  combination of tobramycin 0.3% - dexamethasone 0.1% (TobraDex®, Alcon), one drop four
           times/day, plus Ketorolac tromethamine 0.5% (Acular®, Allergan), one drop three
           times/day. The topical treatment is administered for 28 days after phacoemulsification.

      Patients are independently assessed by two ophthalmologists. On day 28, patients are
      evaluated for

        -  corneal edema

        -  conjunctival redness

        -  anterior chamber reaction. Moreover, the cases necessitating continuation of treatment
           are compared in the two groups on day 28 and 42.
    


Intervention name(s): Tobramycin 0.3% - Dexamethasone 0.1%; Tobramycin 0.3% - Dexamethasone 0.1% plus Ketorolac tromethamine 0.5%
Intervention type(s): Drug; Drug
Intervention MeSH terms: Tobramycin; Dexamethasone; Dexamethasone acetate; Ketorolac; Ketorolac Tromethamine; BB 1101
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cataract; Phacoemulsification; Treatment duration
Malawi International Center of Excellence in Malaria Research School-based Cohort
Condition: Malaria; Malaria,Falciparum; Anemia
MeSH terms: Malaria; Malaria, Falciparum
Study type: Observational

Summary: 
      A school-based, prospective, cohort study was conducted to evaluate the epidemiology of P.
      falciparum (Pf) infections in school-age children and determine the impact of the
      screen-and-treat approach on Pf infection and anemia prevalence among students in two
      different transmission settings. Investigators aimed to evaluate how frequently malaria rapid
      diagnostic tests (mRDTs) fail to detect low-parasite-density infections as well as whether
      low-density infections contribute to the burden and health consequences of Pf infection in
      school-age children and whether they contain gametocytes, the parasite stage required for
      transmission from humans to mosquitos.
    

Detailed description: 
      Students were enrolled in four schools in southern Malawi in the rainy (March-May) and dry
      season (Sept-Nov) of 2015. 15 students per grade-level (grades 1-8), were invited to
      participate. Following enrollment, students were evaluated at baseline for
      screening-and-treatment, and followed-up 1, 2 and 6 weeks later. At each follow-up visit, a
      blood sample was obtained for microscopy and molecular detection of parasites and students
      were interviewed about bed net use the night prior, current or recent illness, and use of
      antimalarial treatment. At the final visit, a mRDT and hemoglobin test were repeated, and
      parents were interviewed and portable medical records ("health passports") were reviewed to
      identify intercurrent fever or malaria treatment.
    

Intervention name(s): Screening and treatment
Intervention type(s): Other
Intervention description(s): Students were screened by mRDTs and treated with artemether-lumefantrine if positive
Other intervention name(s): mRDTs: Paracheck Orchid Biomedical Systems or SD Bioline, Standard Diagnostics Inc.; treatment with artemether-lumefantrine
Intervention MeSH terms: Lumefantrine; Artemether; Artemether, Lumefantrine Drug Combination
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        15 students per grade (1 through 8) were randomly sampled in four primary schools
      
Keywords: cohort; screen and treat; artemether-lumefantrine
TAP Block: Does Volume Make a Difference?
Condition: Post-operative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Patients who have abdominal surgery will experience pain from the incision. The lumbar TAP
      block is a procedure used to reach the nerve endings in the abdominal wall so that there is a
      reduction in pain after surgery. Using ultrasound guidance, a solution of ropivacaine will be
      injected after surgery. The aim of this study is to determine the effect of changes in the
      volume of the injection.
    

Detailed description: 
      Pain from a surgical incision happens in most patients. During the perioperative period, the
      use of the TAP block has been shown to reduce pain scores, opioid consumption and sedation
      scores. Also, there is a trend towards a reduction of post-operative nausea and vomiting. The
      aim of the block is to reach the distal nerve endings of the abdominal wall from T6 to L1
      dermatomes using ultrasound guidance with a single shot of ropivacaine at different volumes.
      Currently, there is consensus about optimal procedure-specific volumes and local anesthetic
      concentrations for lumbar TAP blocks. This is a pilot study and the purpose being is it
      feasible to do a large scale clinical study to determine the influence of increasing the
      local anesthetic volume.
    

Intervention name(s): Ropivacaine; Ropivacaine; Ropivacaine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 20mLs of 0.5%; 30mLs of 0.33%; 40mLs of 0.25%
Other intervention name(s): naropeine; naropin; naropeine; naropin; naropeine; naropin
Intervention MeSH terms: Ropivacaine
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: TAP block; incision pain; total hysterectomy
Could Apnea Induce Hypoalgesia?
Condition: Pain; Apnea
MeSH terms: Apnea
Study type: Interventional

Summary: 
      A randomized controlled trial (RCT) in healthy subjects will be conducted with the following
      aims: (1) Explore the effect of low pulmonary volume dynamic apnoea bouts on Pressure Pain
      Threshold (PPT) and conditioned pain modulation (CPM); (2) analyse whether CPM response
      correlates with apnoea induced hypoalgesia; (3) examine the association between apnoea bouts,
      Rate of Perceived Exertion, hypoxemia and Heart Rate changes in PPT.
    

Detailed description: 
      A randomized controlled trial (RCT) in healthy subjects will be conducted with the following
      aims: (1) Explore the effect of low pulmonary volume dynamic apnoea bouts on Pressure Pain
      Threshold (PPT) and conditioned pain modulation (CPM); (2) analyse whether CPM response
      correlates with apnoea induced hypoalgesia; (3) examine the association between apnoea bouts
      Rate of Perceived Exertion, hypoxemia and Heart Rate changes in PPT
    

Intervention name(s): Apnea; Control Intervention
Intervention type(s): Other; Other
Intervention description(s): In both experimental and control groups participants walked on a treadmill at 5.5 km/h with 5º inclination for 6 minutes. The experimental group (EG) added throughout the 6 minutes intervention the following breathing pattern cyclically: 5 seconds breathing normally followed by 10 seconds of low volume apnoea, performing a total of 24 cycles of normal breathing continued by apnoea.; In both experimental and control groups participants walked on a treadmill at 5.5 km/h with 5º inclination for 6 minutes. The Control group (CG) performed this protocol breathing normally.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pain; Apnoea; Apnea; Hypoalgesia
Referral Patterns for Hospital Acquired Acute Kidney Injury and Relevance to Renal Outcomes
Condition: Renal Replacement Therapy; Mortality
MeSH terms: Acute Kidney Injury
Study type: Observational

Summary: 
      Few studies analyzed the referral time to nephrologists and its impact on the patient outcome
      in a large cohort. The investigators described the incidence and determined the outcome with
      respect to renal function recovery, renal replacement therapy (RRT) requirement and
      in-hospital mortality of Hospital Acquired Acute Kidney Injury (HA-AKI) without nephrology
      referral (nrHA-AKI) and late referred HA-AKI patients to nephrologists (lrHA-AKI) compared
      with early referral patients (erHA-AKI). The patients included were admitted to the tertiary
      care academic center of Lausanne (Switzerland) between 2004 and 2008, in the medical and
      surgical services and in the intensive care unit (ICU).
    


Intervention name(s): Nephrologist referral
Intervention type(s): Other
Intervention description(s): Nephrologist specialty, renal replacement therapy
Other intervention name(s): Control group: early-referred patients with HA-AKI.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        This study population consisted of patients who were hospitalized in the medical and
        surgical departments as well as in the intensive care untis (ICU) of the University
        Hospital of Lausanne (Centre Hospitalier Universitaire Vaudois [CHUV]) that is a tertiary
        care academic medical center. Patients with AKI coming from ICU in the medicine or surgery
        wards, and patients from medicine or surgery wards, who required a transfer to ICU during
        the hospital stay, were also included whatever the cause of the transfer.
      
Keywords: No referral; Late referral; Acute kidney injury; Intensive care unit; In-hospital mortality; Renal outcome; Requirement for renal replacement therapy; Length of hospital stay; Impact; Incidence
Improving Diabetes Care Collaboratively in the Community
Condition: Diabetes
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether a quality improvement intervention
      including rapid quality improvement, a chronic care model, and best practices improves
      diabetes care in community health centers and whether more intensive interventions enhance
      care further.
    

Detailed description: 
      In 1998 the Health Resources and Services Administration's Bureau of Primary Health Care
      began the Health Disparities Collaborative (HDC) to improve chronic disease management in
      community health centers (HC) nationwide. The HDC incorporates rapid quality improvement
      (QI), a chronic care model, and best practices. This study determines if the HDC improves
      diabetes care and whether more intensive interventions with additional learning sessions for
      health centers, provider training in behavioral change, and patient empowerment materials
      enhance care further.
    

Intervention name(s): health disparities collaborative; No additional educational sessions
Intervention type(s): Behavioral; Other
Intervention description(s): The HDC incorporates rapid quality improvement (QI), a chronic care model, and best practices. This study determines if the HDC improves diabetes care and whether more intensive interventions with additional learning sessions for health centers, provider training in behavioral change, and patient empowerment materials enhance care further.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: diabetes; quality improvement; community health center; health disparities
Evaluation of Open-face Maxillary Complete Denture for Patients With Prominent Premaxilla
Condition: Edentulous Jaw
MeSH terms: Jaw, Edentulous
Study type: Interventional

Summary: 
      The aim of the present study was to evaluate open faced maxillary complete denture with soft
      acryl resin wing versus conventional heat cured maxillary complete denture regarding the
      retention and patient satisfaction.
    


Intervention name(s): Conventional denture; Maxillary open-faced denture
Intervention type(s): Device; Device
Intervention description(s): Patients in this group received conventional maxillary and mandibular complete dentures. The patients used these dentures for 45 days. Then, the conventional maxillary denture was replaced by open faced denture with soft acryl resin wing.; Patients in this group received a maxillary open faced denture with soft acryl resin wing and a conventional mandibular complete denture. The patients used these dentures for 45 days. Afterward, the maxillary open-faced denture was replaced by one with a conventional construction.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Prominent Premaxilla
Axillary Lymphadenectomy. A Randomized Trial Comparing Bipolar Vessel Sealing To Conventional Technique
Condition: Axilla Node Dissection
Study type: Interventional
Phase: Phase 3

Summary: 
      lymphorrehea remains the most frequent complication after axillary lymphadenectomy. we
      hyphothesize that the use of a bipolar vessel sealing may reduce the rate of lymph collection
      compared to the traditional surgical technique
    


Intervention name(s): bipolar vessel sealing; control
Intervention type(s): Procedure; Procedure
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: axilla; surgery; technique; bipolar vessel sealing
Comparative, Pharmacokinetic and Pharmacodynamic Study of Subcutaneous Injections of INTP5 of Intas Pharmaceuticals Ltd., India Against Neulasta of Amgen Inc., USA in Healthy, Adult Human Subjects.
Condition: Pharmacokinetic Bioequivalence Study in Human Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The study was an assessor-blind, balanced, randomized, two-treatment, two-period,
      single-dose, two-way crossover, comparative, pharmacokinetic (PK) and pharmacodynamic (PD)
      study of subcutaneous (SC) Pegfilgrastim injection (6 mg/0.6 mL; INTP5 and US-Neulasta) in
      healthy, adult, human subjects under fed conditions.
    


Intervention name(s): INTP5; US Neulasta
Intervention type(s): Combination Product; Combination Product
Intervention description(s): INTP5: A proposed pegfilgrastim biosimilar to US Neulasta.; US Neulasta: FDA-approved pegfilgrastim innovator product.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: Pegfilgrastim; Biosimilar; Bioequivalence; Pharmacokinetics; Pharmacodynamics; Safety; Healthy Volunteers
Program for the Introduction Into Clinical Practice of the Principles of Personalized and Preventive Medicine Based on the Isolation of Gene Polymorphism in Schizophrenia in People of the Kazakh Ethnic Group
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Observational

Summary: 
      This is a GWAS study that aims to identify possible candidate genes associate to
      schizophrenia by exploring single nucleotide polymorphism (SNP) in a group of schizophrenia,
      in the Kazakh population. The investigators hypothesize that the careful phenotyping of the
      subject sand matching with increase the power to find SNP significantly associated with
      schizophrenia
    

Detailed description: 
      A genome-wide association study (GWAS) is an approach used in genetics research to associate
      specific genetic variations with particular diseases. The method involves scanning the
      genomes from many different people and looking for genetic markers that can be used to
      predict the presence of a disease. Once such genetic markers are identified, they can be used
      to understand how genes contribute to the disease and develop better prevention and treatment
      strategies.
    

Intervention name(s): DNA analysis
Intervention type(s): Genetic
Intervention description(s): GWAS
Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Kazakh population
      
Biospecimen description: 
      Blood
    
Keywords: GWAS