bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of Topical Application of Tranexamic Acid in Total Hip Arthroplasty Through the Direct Anterior Approach
Condition: Total Hip Arthroplasty; Postoperative Blood Loss
MeSH terms: Hemorrhage; Postoperative Hemorrhage
Study type: Interventional
Phase: Phase 4

Summary: 
      The effects of topical application of 3g tranexamic acid for 2 hours prior to opening of the
      suction drain following a total hip replacement
    


Intervention name(s): Tranexamic Acid; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 3g of tranexamic acid is topically applied after THA. The drugs is left for 15 minutes or 2 hours; The patients will receive 3g topical TXA for 15 minutes or 2 hours after THA. 33% of the patients will receive 3g of TXA trough a suction drain for 15 minutes after total hip arthroplasty, then the suction drain is opened. 33% will receive the same amount of TXA but the suction drain will only be opened 2 hours after application. The other patients will receive a placebo in the same manner
Intervention MeSH terms: Tranexamic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: total hip arthroplasty; tranexamic acid; postoperative blood loss
Lung Pharmacokinetics (PK) in Epithelial Lining Fluid (ELF)
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to measure and compare the concentration of AAI101 and
      cefepime in bronchial epithelial lining fluid (ELF) and plasma following administration of
      cefepime/AAI101 combination in healthy subjects.
    


Intervention name(s): Cefepime 2 gram
Intervention type(s): Drug
Intervention description(s): Combination of cefepime 2 gram with AAI101 1 gram
Other intervention name(s): AAI101
Intervention MeSH terms: Cefepime
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: bronchial epithelial lining fluid
Comparing Diurnal Fluctuations in Intra Ocular Pressure Measured in Same Day Versus Different Days in Glaucoma Patients
Condition: Glaucoma
MeSH terms: Glaucoma
Study type: Observational

Summary: 
      Glaucoma is one of the leading causes of blindness in the west. The disease caused by high
      intra ocular pressure (IOP) and characterized by damage to the optic nerve and gradual loss
      of visual field. Intra ocular pressure change during the day. To evaluate the efficiency of
      the therapy it is common to measure the intra ocular pressure at different times of the day.
      Most ophthalmologists admit the patient for one day at which intra ocular pressure is
      measured at different times. This method does not mimic the patient daily routine and may not
      reflect the true diurnal fluctuations.

      For this reason some ophthalmologists measure the intra ocular pressure at different times
      and at different days. It is not known if both methods give similar diurnal curves.
    

Detailed description: 
      A study physician will install anesthetic eye drops and will color the eye drops film with
      fluorescein. Study physician will use tonometer to measure the intra ocular pressure in each
      eye. This is a standard procedure done in any ophthalmological examination. Each patient will
      undergo intraocular pressure examination at 8:00, 12:00 and 16:00.

      In the first day intra ocular pressure will be measured at 8:00, 12:00 and 16:00, same day
      measurements. The day after intra ocular pressure will be measured at 8:00, two days after at
      12:00 and three days after at 16:00. One month later the patient will undergo another serious
      of intra ocular pressure measurements.

      In the first day intra ocular pressure will be measured at 8:00, 12:00 and 16:00, same day
      measurements. The day after intra ocular pressure will be measured at 8:00, two days after at
      12:00 and three days after at 16:00.

      The relationship between the two diurnal curves will be analyzed.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Glaucoma patients using eye drops to lower intra ocular pressure.
      
Keywords: Glaucoma; intra ocular pressure; diurnal fluctuations
Paxil CR Bioequivalence Study Brazil - Fed Administration
Condition: Depressive Disorder
MeSH terms: Depressive Disorder
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is prospective, open, randomized, crossover in steady state and the volunteers
      received multiple doses of the test drug and the reference drug (two periods of drug
      administration after standardized meals).
    

Detailed description: 
      Title: Relative bioavailability study between the formulations: Paroxetine Hydrochloride 25
      mg tablet with controlled release (Paxil CR) manufactured by GlaxoSmithKline Inc. -
      Mississauga - Canada (test formulation) and Paroxetine Hydrochloride 25 mg tablets with
      controlled release (Paxil CR) manufactured by SmithKline Beecham (Cork) Limited - Cidra -
      Puerto Rico (reference formulation), fed administration in healthy volunteers of both
      genders.

      The study is prospective, open, randomized, crossover in steady state and the volunteers
      received multiple doses of the drug test and reference (two periods of drug administration).
      The population is composed of 60 healthy volunteers, adult of both gender, with age between
      18 and 40 years, with a body mass index (BMI) between 18.5 and 27. Volunteers have weight
      above than 50 kg. 50% of the volunteers recruited are female and 50% male. There are no
      restrictions regarding the ethnic group.

      The relative bioavailability of the formulations after oral administration in steady state
      will be evaluated based on statistical comparisons of relevant pharmacokinetic parameters
      obtained from data of drug concentration in blood. The concentration of Paroxetine
      hydrochloride (controlled release) will be measured by an appropriate analytical method and
      valid after the drug administration.The Pharmacokinetic samples will be collected at steady
      state in each period after standardized meals. The safety assessment will include evaluation
      and clinical monitoring, vital signs monitoring, ECG, and laboratory tests. Adverse events
      will be monitored throughout the study.
    

Intervention name(s): Paxil CR 25 mg manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico; Paxil CR 25 mg manufactured by GlaxoSmithKline Inc. - Mississauga - Canada
Intervention type(s): Drug; Drug
Intervention description(s): Paroxetine Hydrochloride 25 miligrams(mg) tablet with controlled release (Paxil CR), once a day, manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico (reference formulation); Paroxetine Hydrochloride 25 mg tablet with controlled release (Paxil CR), once a day, manufactured by GlaxoSmithKline Inc. - Mississauga - Canada (test formulation)
Intervention MeSH terms: Halofantrine; Paroxetine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Bioequivalence; Paroxetine reference/test; healthy volunteers; Fed condition
Study on the Measurement of Retinal Blood Flow in Children
Condition: Myopia
MeSH terms: Myopia
Study type: Observational

Summary: 
      In order to provide reference for clinical application, the normal values of retinal blood
      flow parameters in Chinese healthy children were measured by oct-angiography. Meanwhile, the
      repeatability and consistency of retinal blood flow parameters measured by oct-angiography in
      children were further analyzed, and the correlation of retinal blood flow parameters with eye
      axis, choroidal thickness, age and diopter was analyzed, so as to provide basis for clinical
      diagnosis of children's ophthalmopathy. Objective to study the effect of short-term optical
      defocusing on retinal blood flow parameters, and analyze the correlation between the changes
      of posterior segment parameters before and after short-term optical defocusing, so as to
      provide the basis for the possible compensation mechanism of posterior segment optical
      defocusing, and further understand the possible physiological mechanism of myopia.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children volunteers with normal corrected visual acuity
Mirena or Conventional Medical Treatment for Menorrhagia
Condition: Menorrhagia
MeSH terms: Menorrhagia
Study type: Observational

Summary: 
      The aim of this prospective, non-interventional post-marketing surveillance study is to
      obtain data on safety and efficacy of Mirena in treatment of prolonged or heavy menstrual
      bleeding (Menorrhagia) under daily-life treatment conditions.

      It is planned to conduct the study in about 10 countries with a total of 1000 patients. In
      several countries, a comparator group will also be documented.

      For each patient, an initial visit and one to three follow-up visits after about 3, 6 and 12
      months will be documented by the treating physician on the case report form. Observations
      include the patient's demographic parameters (date of birth, height, weight, race and smoking
      habits), previous contraceptives and menorrhagia treatment, gynaecological history, baseline
      menstruation, result of insertion, concomitant medications and diseases as well as
      menorrhagia symptoms. Overall treatment success will be evaluated at the end of treatment
      including number of weeks until improvement and reduction of menstrual bleeding with respect
      to duration and severity, and patient's satisfaction.
    

Detailed description: 
      The "MiCo - Mirena or conventional medical treatment for menorrhagia" study consist of two
      parts, MiCo Asia-Pacific and MiCo MA0901 (Rest of World).

      Data from both parts will be analysed in separate pools as well as in a global pool. The
      trial alias are IMPACT Nos. 14697, 14536 (NCT01085487).
    

Intervention name(s): Levonorgestrel (Mirena, BAY86-5028); Conventional medical treatment; Conventional medical treatment
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Women using Mirena for treatment of menorrhagia; Women using combined oral contraceptives, oral/injectable progestogens, non-steroidal anti-inflammatory drug; Women using anti-fibrinolytic agent for treatment of menorrhagia
Intervention MeSH terms: Levonorgestrel
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women with a diagnosis of idiopathic menorrhagia can be enrolled after decision for
        treatment has been made.
Perioperative Chemotherapy After Primary Chemotherapy for Locally Advanced Breast Cancer
Condition: Breast Neoplasms; Carcinoma
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The role of early timing of adjuvant chemotherapy was postulated to be particularly important
      for patients with endocrine non-responsive disease. The role of cytotoxicity during the
      period of breast surgery itself and immediately after (perioperative chemotherapy) remained
      unknown. We investigated in a randomized trial the role of perioperative chemotherapy in
      patients treated with a preoperative chemotherapy for locally advanced breast cancer and
      compare it to the preoperative chemotherapy without additional cytotoxic therapy during and
      immediately after definitive surgery. Patients with T2-3 N0-2 M0 breast cancer, with both
      estrogen receptors (ER) and progesterone receptors (PgR) expressed in less than 20% of tumor
      cells, or with absence of progesterone receptors, received up to 6 courses of primary
      systemic therapy with epirubicin 25 mg/m2 intravenously (i.v.) on days 1 and 2, cisplatin 60
      mg/m2 i.v. on day 1, and 5-fluorouracil 200 mg/m2 i.v. daily as continuous infusion (ECF).
      Patients achieving a partial or complete remission were randomized to continue the infusion
      of fluorouracil until 2 weeks after surgery (perioperative treatment arm) or to stop
      fluorouracil infusion one week before surgery, on day 21 of the sixth cycle (control arm).
    


Intervention name(s): perioperative chemotherapy
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: antineoplastic protocols; neoadjuvant therapy; perioperative chemotherapy; fluorouracil
Effect of Inspiratory Muscle Training on the Performance of Handball Athletes
Condition: Athletic Performance
MeSH terms: Respiratory Aspiration
Study type: Interventional

Summary: 
      This study investigated the effects of an inspiratory muscle training (IMT) program on the
      respiratory muscle strength and resistance and the aerobic physical performance (PP) of
      handball athletes. Nineteen male athletes took part in the study, allocated at random into
      the experimental group (EG, n=10) and the placebo group (PG, n=9), aged 19±1 and 22±5 years
      old, respectively. The respiratory muscle strength (RMS) was evaluated by measuring the
      maximum inspiratory and expiratory pressures (MIP and MEP, respectively), the muscular
      respiratory resistance was evaluated by maximum voluntary ventilation (MVV) and the aerobic
      PP by applying the cardiopulmonary exercise test. Subsequently the volunteers were submitted
      to an IMT protocol 5 times a week for 12 weeks.
    

Detailed description: 
      The study was designed to evaluate the effects of a 12-week IMT program on the respiratory
      muscle strength and aerobic physical performance of handball players. Nineteen male athletes
      took part in the study, divided into the experimental group (EG), which took part in the
      evaluations, maintained their regular sporting activities and carried out the IMT (n=10), and
      the placebo group (PG), which took part in the evaluations, maintained their regular sporting
      activities and carried out an IMT with a load considered to be placebo (n=09), Experimental
      procedures were carried out by trained researchers and a qualified team. The evaluations and
      IMT were carried out during the competitive season, the training frequency being based on the
      competition program, following the traditional annual model.

      The athletes were submitted to an initial evaluation composed of measuring the respiratory
      muscle strength (RMS) using a manovacuometer, and an evaluation of the aerobic physical
      performance carried out using the cardiopulmonary exercise test (CPET).

      The athletes were reevaluated after 12 weeks for subsequent analysis and comparison with the
      initial values.

      All the subjects were previously informed about the experimental procedures, and signed a
      free and clarified term of consent. The project was approved by the Ethics in Research
      Committee of the Institution with the number 62/13.
    

Intervention name(s): Device POWERbreathe
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Respiratory muscles; athletic performance; handball
Safety and Efficacy of ENV515 Travoprost Extended Release (XR) in Patients With Bilateral Ocular Hypertension or Primary Open Angle Glaucoma
Condition: Glaucoma and Ocular Hypertension
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a multiple cohort study that will evaluate the safety and efficacy of ENV515
      travoprost XR in patients with open-angle glaucoma or ocular hypertension.
    


Intervention name(s): ENV515-3 Travoprost XR; ENV515-1 Travoprost XR; ENV515-3-2 Travoprost XR
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Travoprost
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Benfotiamine and AGE on Endothelial Function in People With Diabetes
Condition: Endothelial Dysfunction; Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to determine whether there are differences in postprandial
      endothelial function following a high-AGE(Advanced Glycation End-products) meal vs. a low-AGE
      meal. We also intend to investigate if the therapy with 1050mg Benfotiamine for 3 days
      protects against the postulated deterioration of endothelial function after a high-AGE meal
      in people with type 2 diabetes mellitus.
    

Detailed description: 
      AGEs are a heterogeneous group of compounds formed by the nonenzymatic reaction of reducing
      sugars with proteins, lipids and nucleic acids. Diet has been recognized as an important
      exogenous source of AGEs. There is evidence for the implication of AGEs in the pathogenesis
      of diabetes-related complications, atherosclerosis, ageing processes or Alzheimer´s disease.
      Although, only little information exists about their effects in humans. The hypotheses of
      this study are that a high-AGE meal leads to a more important acute vascular dysfunction
      comparing to a low-AGE meal, and that a 1050mg/day Benfotiamine therapy for 3 days has a
      protective effect on the endothelial function.

      Twenty-one people with type 2 diabetes shall be investigated in a randomized, single-blinded
      (investigator), cross-over design (please compare design description).
    

Intervention name(s): Benfotiamine 1050mg, 3 days; high-AGE vs. low-AGE meal
Intervention type(s): Drug; Behavioral
Intervention MeSH terms: Benphothiamine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single
Primary purpose: Prevention
Keywords: endothelial dysfunction; flow-mediated dilatation; advanced glycation end products; postprandial
Effects of Linagliptin on Active GLP-1 Concentrations in Subjects With Renal Impairment
Condition: Diabetes Mellitus
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a bi-centric, prospective, open study comparing the effects of linagliptin on active
      GLP-1 concentrations in subjects with renal impairment compared to subjects with normal renal
      function.
    


Intervention name(s): Linagliptin
Intervention type(s): Drug
Intervention MeSH terms: Linagliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluating an Online Adjunctive Support Following Intensive Services (OASIS) Strategy for Youth With Selective Mutism
Condition: Selective Mutism
MeSH terms: Mutism
Study type: Interventional

Summary: 
      This study sought to evaluate an innovative post-acute continuation/transition planning
      treatment strategy that leveraged an in-person intensive treatment followed by online,
      videoconferencing-based "booster" sessions for youth with selective mutism (SM). Twenty
      children between the ages of 4 and 10 and their caregivers were scheduled to participate in
      an in-person intensive group behavioral treatment (IGBT) for SM and subsequently randomized
      to receive either (a) six, biweekly, hour-long, videoconferencing-delivered booster sessions
      or (b) no additional treatment for 12 weeks. Due to COVID-19-related physical distancing
      restrictions, the study team was unable to provide in-person services. Thus, the clinical
      trial was converted to an open-trial design focused on evaluating remote treatment options
      (i.e., remotely delivered caregiver training sessions and/or a remotely delivered IGBT) for
      these families. All families retained in the study have or will participate(d) in assessments
      at the following time points: Intake (i.e., 4-5 months prior to the remote IGBT); Baseline
      (i.e., 1 month prior to the IGBT), Post-IGBT (i.e., 2 weeks following the IGBT), and School
      Year Follow Up (i.e., 16 weeks following the IGBT).
    


Intervention name(s): Remote Caregiver Training; Remote Intensive Group Behavioral Treatment (IGBT)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The remote caregiver training is a 5-hour videoconferencing-based training program that focuses on teaching cognitive behavioral therapy skills to the caregivers of children with selective mutism in a group format across 3 sessions.; The remote IGBT is a 5-day videoconferencing-based treatment program that delivers cognitive behavioral therapy to children and their caregivers in a group format across 2-3 hours per day.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: All participating families attend videoconferencing-based group parent training sessions. Families are given the opportunity to opt in to participate in the videoconferencing-based intensive group behavioral treatment program (remote IGBT).
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment