bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety Study to Delay Renal Failure in Children With Alport Syndrome
Condition: Renal Insufficiency, Chronic
MeSH terms: Renal Insufficiency; Renal Insufficiency, Chronic; Nephritis, Hereditary
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a phase III, multi-centre, randomised, placebo-controlled, patient and
      investigator-blind study in paediatric patients with early stages of Alport syndrome to
      assess the safety and efficacy of the ACEi ramipril in slowing disease progression.

      Alport syndrome stages that describe the extent of renal damage and loss of function are
      defined as:

        -  0 Microhaematuria without microalbuminuria (usually at birth)

        -  I Microalbuminuria (30-300 mg albumin/gCrea)

        -  II Proteinuria >300 mg albumin/gCrea

        -  III > 25% decline of normal renal function (creatinine clearance)

        -  IV End stage renal failure (ESRF)

      Eligible patients with Alport stages 0 and I will be randomly assigned at a 2:1 ratio to
      receive once daily ramipril or placebo. In addition, Alport stage II patients may be treated
      open Label. Eligible patients who, or whose parents/legal guardian refuse randomisation after
      eligibility is confirmed, and patients who have been treated with ramipril prior to the
      study, may be treated open-label with ramipril as per protocol. The total number of patients
      will not exceed 120, with the number of randomised patients not exceeding 60, and the number
      of patients treated open label from Day 1 of the study aimed to be approximately 60.

      Randomised patients whose disease progresses to the next disease level during the 3 year
      treatment period will be unblinded, and open label ramipril treatment will be initiated and
      continued, respectively, depending on prior treatment randomisation.
    


Intervention name(s): Ramipril; placebo to ramipril; Ramipril
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Ramipril (Delix) tablets containing 2.5 mg ramipril, oral application with 1 to 6 mg per body surface area ramipril once daily for 3 years.; Oral application of placebo to ramipril, once daily with 1 to 6 mg per body surface area for 3 years or until disease progression.; Oral treatment with 1 to 6 mg per body surface area ramipril once daily for 3 years as per protocol.
Intervention MeSH terms: Ramipril
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Alport Syndrome; chronic kidney disease; renal fibrosis; nephroprotection; pediatric study
The Noergaard Technique for Anterior Shoulder Dislocation
Condition: Anterior Shoulder Dislocation
MeSH terms: Joint Dislocations; Shoulder Dislocation
Study type: Observational

Summary: 
      In this paper we describe and evaluate the results of the Noergaard technique through a
      retrospective analysis of patients admitted and treated for anterior shoulder dislocation at
      the ED of Copenhagen University Hospital Hvidovre, Denmark, in a 1-year period.
    

Detailed description: 
      Introduction

      In this article the investigators describe the Noergaard technique for reduction of anterior
      shoulder dislocations. This is an atraumatic reduction method that has proven successful
      through several years of practice. The investigators describe and evaluate the results of
      this technique through a retrospective analysis of patients admitted and treated for anterior
      shoulder dislocation at the emergency department (ED) of Copenhagen University Hospital
      Hvidovre, Denmark, in a 1-year period.

      Methods

      In the Noergaard technique the patient is placed standing bend over forwards in front of the
      rail on a hospital bed, resting the forehead on the back of the non-affected forearm, which
      is put on the rail. The affected arm should now be relaxed and stretched, hanging straight
      down toward the floor. The patient is then instructed to attempt to relax and make pendular
      and circular motions with the affected arm hanging down.
    

Intervention name(s): Noergaard technique
Intervention type(s): Procedure
Intervention description(s): The patient is placed standing in an upright position in front of the rail on a hospital bed. Legs should be stretched with a wide well balanced stance. The patient is then instructed to bend forwards, resting the forehead on the back of the non-affected forearm, which is put on the rail. The affected arm should now be relaxed and stretched, hanging straight down toward the floor. The patient is then instructed to attempt to relax and make pendular and circular motions with the affected arm hanging down. Successful reduction occurs when sufficient muscle relaxation allows the humeral head to reposition to its natural position in the glenoid fossa. Often the patient will experience a popping sensation when the shoulder is reduced.
Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The study population is chosen from the criteria that patients have had a closed shoulder
        reduction performed at the emergency center of Hospital of Hvidovre between 1st of January
        2014 and the 31st of December 2014.
      
Keywords: Shoulder; Dislocation; Noergaard; Reduction
Efficacy Study of Clinical Nutrition to Treat Lung Neoplasms And Breast Carcinoma
Condition: Lung Neoplasms; Breast Neoplasms
MeSH terms: Neoplasms; Breast Neoplasms; Lung Neoplasms
Study type: Interventional

Summary: 
      This study evaluates the efficacy of clinical nutrition to treat lung neoplasms and breast
      carcinoma.We estimate there will be 480 patients accepted.120 patients will receive GLSE
      compound,120 patients will recrive Maitake mushroom extract compound,120 patients will
      recrive Rinseng compound,and 120 patients will be as blank countrol group.Efficacy Study of
      Clinical Nutrition to Treat Lung Neoplasms And Breast Carcinoma
    

Detailed description: 
      GLSE compound、Maitake mushroom extract compound and Rinseng compound have different mechanism
      on enhancing immunity.This clinicaltrial compare them the immune effect in the progress of
      treating lung neoplasms and breast carcinoma.Within the 42 days,we will abide by the plan to
      evaluate the immunity enhancement by monitoring mmune effector molecules.
    

Intervention name(s): GLSE compound; Maitake mushroom extract compound; Ginseng compound
Intervention type(s): Drug; Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: Clinical Nutrition
Single Dose Study of the Effect of Formoterol Fumarate in Combination With Mometasone Furoate Inhaled Via a Pressurized Metered Dose Inhaler (pMDI) in Children Aged 5-11 Years Old With Persistent Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is being conducted to compare the pharmacodynamics (bronchodilation, onset and
      duration of action), of a single dose of formoterol fumarate in combination with mometasone
      furoate to placebo in children of 5-11 years with persistent asthma. The study will also
      assess the bronchodilatory effect of a single dose of formoterol fumarate alone and in
      combination with mometasone furoate delivered via a pressurized metered dose inhaler (pMDI)
      to the bronchodilatory effect of formoterol fumarate delivered via a dry powder inhaler
      (DPI). Furthermore, pharmacokinetic assessments of plasma and urine will also be conducted
      throughout the study to assess systemic exposure following administration of the study
      medication.
    


Intervention name(s): Mometasone furoate/formoterol fumarate (MFF); Formoterol fumarate 12 μg pMDI (F12M); Formoterol fumarate 12 μg DPI (F12D); Placebo to F12D; Placebo to F12M/MFF
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Formoterol fumarate dihydrate / mometasone furoate combination product 10 μg / 100 μg delivered via Pressurized Metered Dose Inhaler (pMDI). One dose consisted of 2 puffs x 5 μg / 50 μg.; Formoterol fumarate dihydrate 12 μg delivered via Pressurized Metered Dose Inhaler (pMDI) (1 dose = 2 puffs x 6 μg).; Formoterol fumarate dihydrate 12 μg delivered via Dry Powder Inhaler (DPI).; Placebo to formoterol fumarate DPI delivered via DPI; Placebo to formoterol fumarate pMDI and formoterol fumarate / mometasone furoate delivered via pMDI
Intervention MeSH terms: Mometasone Furoate; Formoterol Fumarate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Asthma; Children; Persistent asthma
Thalidomide Plus Dexamethasone as Maintenance Therapy for Multiple Myeloma
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Study type: Interventional
Phase: Phase 3

Summary: 
      This multicenter, prospective, randomized trial was designed to evaluate the role of
      thalidomide with or without dexamethasone as a maintenance therapy for multiple myeloma
      patients after a single autologous stem cell transplantation.
    

Detailed description: 
      Patients were recruited prior to receiving induction therapy, and randomization in a 1:1
      ratio occurred on day 60 post-autologous stem cell transplantation. The treatment consisted
      of the following four phases:

        1. induction with 3-5 cycles of vincristine plus doxorrubicin and dexamethasone (VAD) every
           21-28 days: vincristine 0.4 mg , doxorubicin 9 mg/m² and oral dexamethasone 40 mg daily
           for 4 days;

        2. cyclophosphamide (4 g/m2 ) plus filgrastim (G-CSF) (5 μg/kg twice a day) for stem cell
           mobilization;

        3. melphalan (200 mg/m2 ) and one autologous stem cell transplant (ASCT);

        4. Sixty days (D +60) after ASCT: RANDOMIZATION in two arms of maintenance: Arm A (oral
           dexamethasone alone 40 mg/d for 4 days every 28 days) and Arm B (dexamethasone plus
           thalidomide 200 mg daily by mouth) for 12 months or until disease progression.
    

Intervention name(s): Thalidomide plus dexamethasone; Dexamethasone
Intervention type(s): Drug; Drug
Intervention description(s): D+60 after ASCT: randomization in two arms of maintenance: Arm A (dexamethasone alone 40 mg/day for 4 days every 28 days) and Arm B (dexamethasone plus thalidomide 200 mg by mouth daily) for 12 months or until disease progression.
The dose of thalidomide could be reduced if the patient experienced grade 2 or higher adverse events. In this case, thalidomide was discontinued and re-challenged at a lower dose after resolution of the adverse event.; dexamethasone alone 40 mg/day for 4 days every 28 days
Other intervention name(s): Thalomid; Baycadron; DexPak; Decadron; Baycadron; DexPak; Decadron
Intervention MeSH terms: Thalidomide; Dexamethasone; Dexamethasone acetate; BB 1101
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Multiple Myeloma; Treatment; Maintenance; Thalidomide
Fascia Iliaca Block for Anesthesia in Lower Limb Thromboembolectomy
Condition: Chronic Lower Limb Ischemia
MeSH terms: Ischemia
Study type: Interventional

Summary: 
      The fascia iliaca block (FIB) is an anterior approach to block the lumbar plexus. It
      disturbed mainly to the anterior region of the thigh by blocking the femoral nerve (LFC) and
      the lateral femoral cutaneous nerve. Moreover, FIB may possibly be extended to the obturator,
      ilioinguinal, genitofemoral, lateral cutaneous nerve of the thigh and over the psoas muscle
      but, rarely reaches the lumbar plexus.

      The fascia iliaca compartment could be detected by bony landmarks palpation and the loss of
      resistance technique. Feeling two tactile ''pops'' due to loss of resistance occurred during
      the needle passage through the fascia lata and the fascia iliaca. Ultrasound (US) guidance of
      FIB will increase the success rate and the efficacy of sensory blockade by decreasing the
      needed local anesthetic amount.
    

Detailed description: 
      This study was conducted to demonstrate the success incidence (to evaluate the efficacy) of
      preoperative 0.25% bupivacaine FIB as a sole anesthetic technique in thromboembolectomy of
      unilateral chronic lower limb ischemia compared to neuraxial anesthesiaas a primary goal.
      Intraoperative hemodynamics variation, postoperative pain score, total analgesic rescue
      requests and the total amount of systemic rescue analgesia used in the first postoperative
      day in addition to any detected postoperative complications were secondary goals. The
      hypothesis is that; FIB will provide adequate anesthesia as neuraxial anesthesia.
    

Intervention name(s): Fascia iliaca block (FIB); Spinal anesthesia
Intervention type(s): Drug; Other
Intervention description(s): ultrasound-guided Fascia iliaca block; Spinal anaesthesia using 2 ml hyperbaric bupivacaine 0.5%
Intervention MeSH terms: Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
The Effect of Orexin on Delayed Emergence of General Anesthesia in Dexmedetomidine
Condition: Anesthesia
Study type: Interventional

Summary: 
      The current study is designed to investigate the difference of plasma orexin A levels between
      Dexmedetomidine group and controlled group at emergence time from total intravenous
      anesthesia who will undergo elective lumbar surgery.
    

Detailed description: 
      DESIGNING: Fifty-one patients with ASA physical status I or II scheduled for elective surgery
      under general anesthesia (lasting for 2h to 4h) were enrolled. Anesthesia was induced with
      propofol 1-2mg/kg and sufentanyl 0.2-0.3μg/kg. Following muscle relaxation with iv
      cisatracurium besylate 0.2mg/kg endotracheal intubation was performed. Anesthesia was
      maintained with target controlled infusion propofol (targeted concentration:2-5ug/ml ) and
      remifentanil (targeted concentration: 2-6ng/ml ). Muscle relaxation was maintained with
      intermittent, but it do not injected in 1h before surgery completion. Propofol and
      remifentanil were titrated to maintain the bispectral index (BIS) between 40 and 60 during
      anesthesia. The end-tidal carbon dioxide level was maintained between 30 and 40 mmHg by
      controlled mechanical ventilation. When the surgery was completed the investigators adjust
      the targeted concentration of propofol 2ug/ml and targeted concentration of remifentanil to
      2ng/ml then stop all anesthetics. Dexmedetomidine group target controlled infusion
      dexmedetomidine (induction dose 1ug/kg with 10min, maintain dose 0.4ug/kg/h until 30min
      before surgery completion). Control group infusion same saline. Record time from stopping
      anesthetics to emergence and total doses of anesthetics. Arterial blood (2.5ml) was collected
      at the following time, such as before and 1h after induction of anesthesia, at emergence (1
      min after tracheal extubation) and half an hour after tracheal extubation. 2.0ml Arterial
      blood was centrifuged at 3000 rpm for 15min at -4 ◦C in order to separate plasma then stored
      at -80 ◦C until assay for orexin A concentrations. 0.5ml Arterial blood was measured blood
      glucose.
    

Intervention name(s): Dexmedetomidine; Saline
Intervention type(s): Drug; Drug
Intervention description(s): Dexmedetomidine is common used to improve the prognosis and life quality of patients.; It is safe Placebo.
Other intervention name(s): Dexmedetomidine is a highly selective α2-adrenoceptor agonist.; It is safe Placebo.
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Study to Evaluate Multiple Doses in Patients With Nasal Polyposis
Condition: Nasal Polyposis
MeSH terms: Colorectal Neoplasms; Nasopharyngeal Neoplasms; Nasal Polyps
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a phase 2 study to evaluate multiple doses of AK001 across 2 active doses.
      Pharmacodynamic activity will also be evaluated.
    

Detailed description: 
      AK001 is a monoclonal antibody which may be useful in the treatment of patients with moderate
      to severe nasal polyposis
    

Intervention name(s): AK001 low dose; AK001 high dose; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 25 mg AK001 will be administered as multiple doses; 250 mg AK001 will be administered as multiple doses; Placebo will be administered as multiple doses
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Phase 1b Study of Thymosin Beta 4 in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to evaluate the safety, tolerance, pharmacokinetics and the
      potential immunological reaction of single intravenous recombinant human thymosin β4（NL005）or
      placebo 0.5, 2.0,5.0μg/kg in Chinese healthy volunteers.30 volunteers will be randomly
      assigned to one of three groups to receive either NL005 or placebo for 10 consecutive days.
    

Detailed description: 
      This study was a randomized, double-blind, placebo-controlled study to evaluate the safety
      and tolerability pharmacokinetics and potential immune responses of multiple NL005
      intravenous administration.

      Three groups of 30 subjects will receive an NL005 or placebo dose of 0.5μg/kg 2.0 μg/kg and
      5.0 μg/kg for 10 consecutive days at a ratio of 4:1.

      While observing the safety of the subjects in each dose group, about 5mL of venous blood was
      collected for the ADA study in healthy subjects 14 days and 28 days after the first
      administration of the drug.
    

Intervention name(s): Recombinant Human Thymosin β4; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Healthy subjects , were given a dose of rh-Tβ4 for ten consecutive days.; 3 cohorts, with 6 healthy subjects , were given a dose of Placebo for ten consecutive days. Cohorts received ascending doses of either 0.5,2.0 or 5.0 ug/kg .
Other intervention name(s): rh-β4
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Dose Escalation for 3 Cohorts.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Recombinant human thymosin β4
Evaluation of an Integrated Economic Strengthening and HIV Prevention Program for Vulnerable Youth in South Africa
Condition: HIV; HIV Infections
MeSH terms: HIV Infections
Study type: Interventional

Summary: 
      This study evaluates whether the integration of an Economic Strengthening program with an
      HIV-prevention education program produce synergistic effects on economic and health outcomes
      for South African youth ages 14-17 years old.
    

Detailed description: 
      In South Africa, the overall HIV prevalence of 12.2% can be reviewed based on a number of
      factors: age, province, type of locality, race, economic household conditions, and marital
      status. Those to be reached through the ASPIRES intervention and evaluation are economically
      disadvantaged Black African youth, male and female, located in urban localities in Gauteng
      province, and are situated within a setting of high risk and vulnerability for HIV. The
      ASPIRES project is providing technical assistance to provide economic strengthening (ES) and
      HIV prevention education programming for adolescents. The ASPIRES ES intervention includes
      financial capability building through the provision of financial education in combination
      with access to appropriate youth-friendly savings mechanisms. The HIV prevention education
      intervention Vhutshilo 2.2 will be used in this study.

      This study will assess whether the integration of an ES intervention with an HIV-prevention
      education intervention improves economic and health outcomes beyond singular interventions,
      estimate the resources required at the program level to support the ES and HIV-prevention
      education interventions; and describe whether the interventions were perceived as effective
      in addressing economic and health outcomes and to describe how and why the interventions were
      perceived as effective or not.

      This study will enroll up to 2000 youth ages 14-17 and randomly assign them to either 1) ES
      intervention only, 2) HIV prevention intervention only, 3) combined ES and HIV intervention,
      or 4) no intervention.
    

Intervention name(s): Economic Strengthening (Impumelelo); HIV Prevention Education (Vhutshilo 2.2)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Economic Strengthening (Impumelelo): This intervention consists of 15 one-hour long sessions on financial education in combination with access to appropriate youth-friendly savings mechanisms.; HIV Prevention Education (Vhutshilo 2.2): This intervention consists of 15 one-hour long sessions that are interactive, skills focused, and cover such topics as expressing one's feelings; dealing with loss and grief; decision-making; coping; gender violence; understanding HIV and other sexually transmitted infections; healthy relationships and staying safe in sexual relationships; and contraception and risks associated with unplanned pregnancy.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: ASPIRES
A Phase 2 Trial to Evaluate the Efficacy and Safety of Linezolid in Tuberculosis Patients. (LIN-CL001)
Condition: Pulmonary Tuberculosis
MeSH terms: Tuberculosis; Tuberculosis, Pulmonary
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the mycobactericidal activity, safety, tolerability,
      and pharmacokinetics of 6 doses of linezolid: 300 mg once per day, 300 mg twice per day, 600
      mg once per day, 600 mg twice per day and 1200 mg once per day administered orally for 14
      consecutive days or 1200 mg administered three times per week for two weeks in adult subjects
      with newly diagnosed drug-sensitive, smear-positive pulmonary tuberculosis.
    


Intervention name(s): Linezolid; HRZE (isoniazid rifampicin,pyrazinamide,ethambutol)
Intervention type(s): Drug; Drug
Intervention description(s): isoniazid (H) 75 mg plus rifampicin (R) 150 mg plus pyrazinamide (Z) 400 mg plus ethambutol (E) 275 mg
Intervention MeSH terms: Rifampin; Isoniazid; Linezolid; Pyrazinamide; Ethambutol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Tuberculosis; Drug-Sensitive Tuberculosis; Linezolid; HRZE (isoniazid, rifampicin, pyrazinamide, ethambutol); Pulmonary Tuberculosis; TB