bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Evaluate Bioequivalence and Adhesion of a Transdermal Contraceptive Patch Manufactured With Newly Sourced Adhesive Components and Currently Marketed EVRA in Healthy Adult Women
Condition: Healthy
MeSH terms: Tissue Adhesions
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine the bioequivalence of the hormones (ie,
      norelgestromin [NGMN] and ethinyl estradiol [EE]) from the transdermal contraceptive patch
      and to evaluate the adhesion of the transdermal contraceptive patch using the newly sourced
      adhesive component, as compared to the currently marketed EVRA patch.
    


Intervention name(s): EVRA patch (NGMN+EE) (Treatment A) (Reference); HMW PIB patch (NGMN+EE) (Treatment B) (Test)
Intervention type(s): Drug; Drug
Intervention description(s): A single transdermal contraceptive patch of EVRA (NGMN + EE) containing 6 milligram (mg) of the progestin NGMN and 600 microgram (mcg) of the EE will be applied to the buttock (right or left) of participants on Day 1 of each treatment period and is removed 7 days after patch application, ie, on Day 8.; A single transdermal contraceptive HMW PIB (NGMN + EE) patch containing 6 mg of the progestin NGMN and 600 mcg of the EE will be applied to the buttock (right or left) of participants on Day 1 of each treatment period and is removed 7 days after patch application, ie, on Day 8.
Other intervention name(s): RWJ10553; RWJ10553
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
An Absolute Bioavailability Study in Healthy Participants Comparing Oral to Intravenous Administration of GDC-0973 (Cobimetinib)
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of Part 1 of this study is to evaluate the safety and tolerability of
      the intravenous (IV) dose of GDC-0973. The primary objectives of Part 2 of this study are to
      evaluate the absolute bioavailability of GDC-0973 and to evaluate the pharmacokinetic (PK) of
      GDC-0973 following IV and oral administration. The secondary objective of Part 2 of this
      study is to evaluate the safety of GDC-0973 administered orally and intravenously.
    


Intervention name(s): GDC-0973 IV Infusion; GDC-0973 Oral Capsules
Intervention type(s): Drug; Drug
Intervention description(s): IV infusion.; Oral dose.
Other intervention name(s): XL518; XL518
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Determination of the Safety and Effectiveness of an Oral Rinse in the Reduction of Medication Associated Metallic Taste
Condition: Medication Associated Metallic Taste , Dysgeusia
MeSH terms: Dysgeusia; Taste Disorders
Study type: Interventional

Summary: 
      Patients taking chemotherapeutic agents often do not comply well with their dosing regiment
      since many of these medications cause a metallic taste in the mouth. The primary intent is to
      determine the effectiveness of the oral rinse in reducing the metallic taste in the mouth
      associated with various chemotherapeutic agents. This clinical study a randomized,
      double-blind, single-treatment, parallel design with a placebo as the control. The duration
      of the trial will be 1 month.
    


Intervention name(s): Metaqil™ Oral Rinse; Placebo
Intervention type(s): Device; Device
Intervention description(s): Metaqil™ is a proprietary formulation of GRAS ingradients; Placebo formulation with out the active ingredients
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Supportive Care
The Effects of Annovera™ and Tampon Co-Usage on the Pharmacokinetics of Segesterone Acetate and Ethinyl Estradiol
Condition: Contraception
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the effect of Annovera and tampon co-usage on the pharmacokinetics
      (PK) of segesterone acetate (SA) and ethinyl estradiol (EE).
    

Detailed description: 
      This is an open label, randomized, crossover PK study. Participants will be randomized to one
      of two treatment sequences. Each treatment sequence consists of two cycles of treatment - one
      with tampon use and one without tampon use. Tampon use will occur on Days 2 to 5 of
      contraceptive vaginal system (CVS) use and a new CVS will be used for each treatment cycle.
      Before starting Annovera use, each subject will use a combined oral contraceptive (COC) for
      one cycle.
    

Intervention name(s): Segesterone Acetate and Ethinyl Estradiol; Tampon
Intervention type(s): Drug; Other
Intervention description(s): Annovera taken alone; Annovera with tampon use
Other intervention name(s): Annovera
Intervention MeSH terms: Ethinyl Estradiol; Estradiol
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This is an open label, randomized, crossover PK study. Participants will be randomized to one of two treatment sequences. Each treatment sequence consists of two cycles of treatment - one with tampon use and one without tampon use. Tampon use will occur on Days 2 to 5 of contraceptive vaginal system (CVS) use and a new CVS will be used for each treatment cycle. Before starting Annovera use, each subject will use a combined oral contraceptive (COC) for one cycle.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: tampon; vaginal ring
Impact of Early Non Invasive Ventilation in Amyotrophic Lateral Sclerosis (ALS) Patients
Condition: Amyotrophic Lateral Sclerosis
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      Timing of initiating domiciliary no invasive ventilation (NIV) in amyotrophic lateral
      sclerosis patients remains unclear. The hypothesis of the study is that the early use of NIV,
      in the initial phase of respiratory muscle weakness, improves the prognosis of ALS patients.

      Principal objective: To evaluate the impact of early NIV in the survival of ALS patients.

      Secondary objectives:To determine the effects from early NIV in the progression of
      respiratory muscle weakness. To analyze the impact of early NIV in the quality of life of ALS
      patients. To evaluate the correlation between the FVC and other parameters of respiratory
      evaluation (maximal inspiratory pressure (MIP), sniff nasal inspiratory pressure (SNP),
      nocturnal desaturation) and their utility in the early indication of the NIV. To evaluate the
      tolerance to the early NIV.

      Methods: multicentric, randomized, open-label, controlled clinical trial with a parallel
      treatment design. Patients will be included when their FVC reaches the threshold of the 75%
      of the predicted value and will be randomized in: Group A: the NIV treatment will begin
      immediately and Group B: the NIV treatment will be started when patients fulfil at least one
      of the following criteria: (i) FVC < 50% predicted, (ii) orthopnea, and/or (iii) PaCO2 > 45
      mmHg. Follow-up visits will be done every three months with pulmonary function test,
      nocturnal pulse oximetry, quality of life and quality of sleep tests, assessment of disease
      progression (ALSFSR-R scale), tolerance and compliance with NIV.
    

Detailed description: 
      ALS patients with early impairment of respiratory muscles (FVC around 75%) will be radomised
      to initiate NIV or conventional follow-up.

      The NIV treatment will be initiated during a hospital with the model of ventilator VIVO 40
      (BREAS Medical AD, Sweden) using a pressure support assisted/control mode, with a minimum
      pressure support 10 cm.

      Initial NIV indication in both groups of patients will nocturnal. Patients will be defined as
      tolerant to NIV if they do not refer inconveniences and is able to asleep with NIV.

      The efficacy of the intervention will be compared in both groups with survival until death or
      change to invasive tracheal ventilation as a prymary efficacy parameter.
    

Intervention name(s): Home pressure ventilator model Vivo 40 (BREAS Medical AB)
Intervention type(s): Device
Intervention description(s): Nocturnal non invasive ventilation (Vivo 40)with minimum pressure support of 10 cm H2O (IPAP 14, EPAP 4). Parameters will be adjusted according to tolerance and to achieve PaCO2 < 45 mmHg and improve symptoms.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study In Patients With Type 2 Diabetes Who Are Taking Metformin And Sulfonylurea, Metformin And Insulin, Or Insulin
Condition: Non-Insulin-Dependent Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will use Magnetic Resonance Imaging (MRI) techniques to evaluate changes in fluid
      volume in the lower legs of diabetic patients who add either pioglitazone or placebo to their
      current diabetic regimen.
    


Intervention name(s): pioglitazone
Intervention type(s): Drug
Intervention MeSH terms: Pioglitazone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: pioglitazone; diabetes; fluid
A Phase 1/2 Study to Assess MultiStem® Therapy in Acute Respiratory Distress Syndrome
Condition: Acute Respiratory Distress Syndrome
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Syndrome
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      A study to examine the safety (and potential efficacy) of the adult stem cell investigational
      product, MultiStem, in adults who have Acute Respiratory Distress Syndrome (ARDS). The
      primary hypothesis is that MultiStem will be safe in ARDS patients.
    


Intervention name(s): MultiStem; MultiStem; Placebo
Intervention type(s): Biological; Biological; Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Drug-Drug Interaction Study to Assess the Effects of Multi Dose Clopidogrel on the Pharmacokinetics of Single-Dose K-877 in Healthy Adult Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to assess the effects of clopidogrel on the PK of
      K-877 in healthy adult subjects.
    


Intervention name(s): K-877; Clopidogrel
Intervention type(s): Drug; Drug
Intervention MeSH terms: Clopidogrel
Intervention model: Single Group Assignment
Masking: None (Open Label)
COVID-19 Pandemic and Parents of Disabled Children
Condition: COVID-19; Disabilities Multiple; Cerebral Palsy; Muscular Dystrophies
MeSH terms: COVID-19; Muscular Dystrophies; Cerebral Palsy
Study type: Interventional

Summary: 
      Pandemic period could affect the disabled children's rehabilitation and follow-up negatively
      because of preventive measures and this could create adverse results on their parents.

      In this research, it is aimed to determine the positive and negative effects of pandemic on
      parents and disabled children and to provide an insight for future solutions.
    

Detailed description: 
      To determine the effect of COVID-19 pandemic and the possible difficulties experienced by the
      parents of disabled children, a questionnaire was prepared. It takes approximately 10-15
      minutes to complete the survey. Questionnaire is loaded to qualtrics program and sent to the
      families by e-mail or social media accounts.
    

Intervention name(s): Difficulties lived by disabled children's parents in the period of COVID-19 pandemic
Intervention type(s): Other
Intervention description(s): It will be a cross sectional study to obtain the information on difficulties lived by disabled children's parents during recent pandemic period
Intervention model: Single Group Assignment
Intervention model description: One study group will be researched- only disabled children's parents, in one arm -way
Masking: None (Open Label)
Primary purpose: Screening
Keywords: cerebral palsy; COVID-19; pandemic; disability
Micafungin Pharmacokinetics in Obese Patients
Condition: Morbid Obesity
MeSH terms: Obesity, Morbid
Study type: Interventional
Phase: Phase 4

Summary: 
      Because micafungin is generally well tolerated and appears to have limited interaction with
      other drugs, it is a potential important agent in the treatment of invasive fungal
      infections. Although micafungin is approved for the treatment of invasive candidiasis, dosing
      guidelines for micafungin in (morbidly) obese patients are not available. Subsequently, the
      pharmacokinetic profile of micafungin (as well as other echinocandins) in this specific
      patient population is still largely unknown.

      To build a valid pharmacokinetic model, obese patients with a BMI ≥ 40 undergoing endoscopic
      gastric bypass surgery will receive a single dose of 100 mg or 200mg micafungin (besides
      standard anti-bacterial prophylaxis) and samples for a pharmacokinetic curve will be taken.
      These PK-values can then be compared to the PK in a normal-weight group which will receive
      100mg micafungin
    

Detailed description: 
      Obese patients with a BMI ≥ 40 kg/m2 undergoing endoscopic gastric bypass surgery will
      receive a 100 mg or a 200mg dose of micafungin. A PK curve will be determined after
      administration at t=0.5, 0.95, 1.25, 1.5, 2, 4, 8, 12, 24, and (if feasible) 48 hours post
      infusion. Blood samples (4 mL) on PK days will be taken to obtain at least 2.0 mL of plasma.
    

Intervention name(s): Micafungin
Intervention type(s): Drug
Intervention description(s): Administration of study drug
Other intervention name(s): Mycamine
Intervention MeSH terms: Micafungin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Effect of Exercise Training on Angiogenesis and Cachexia in Lung Cancer Patients
Condition: Non-small-cell Lung Cancer
MeSH terms: Lung Neoplasms; Cachexia
Study type: Interventional

Summary: 
      Cancer is one of the leading health issues in this country and worldwide. Angiogenesis is an
      essential process for tumoral growth and metastasis. This process is dependent on the balance
      between angiogenic factors and antiangiogenic factors. Muscle wasting has been associated
      with myostatin overexpression in cancer. Exercise training can depress tumor growth and
      suppress myostatin expression, and enhance skeletal muscle angiogenesis in healthy people and
      some animal studies. The purpose of this study is mainly to investigate the effects of
      exercise training on

        1. circulating VEGF-A

        2. muscle growth and function

        3. Myostatin
    


Intervention name(s): Exercise training; Usual care
Intervention type(s): Behavioral; Other
Intervention description(s): Subjects in exercise group will undergo individualized high aerobic interval training on treadmill for 30 minutes under the supervision of an experienced physical therapist 3 times a week and home exercise twice a week with accelerometer.; Subjects in control group will not undergo individualized high aerobic interval training on treadmill. They will receive usual care as normally does in hospital.
Other intervention name(s): High intensity interval aerobic training; Non-exercise or patient education
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Tumor; Angiogenesis; Exercise training; VEGF; Myostatin
Auriculotherapy in Tension-type Headache Due to Temporomandibular Dysfunction
Condition: Tension-Type Headache
MeSH terms: Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome; Tension-Type Headache; Headache
Study type: Interventional

Summary: 
      Objectives: Verify the effect of auriculotherapy in patients with tension-type headache
      resulting from temporomandibular dysfunction.

      Design: Randomized clinical study Setting: Randomized Study Participants: The study consist
      of 38 participants randomized into two groups: an intervention group (n = 18, sample loss =
      1) and placebo group (n = 20, sample loss = 6) Interventions: The intervention group will
      receive treatment with auricular acupuncture in the Shen Men, Kidney, Sympathetic, Subcortex,
      Adrenal and Cerebral points. The placebo group will receive auriculotherapy in the trachea
      point.

      Main outcome measures: visual analog scale for pain pain (VAS) and surface electromyography
      (EMG).
    

Detailed description: 
      This is an experimental clinical trial in which will be selected at the University, 40
      students with tension-type headache due to temporomandibular dysfunction. Among the selected
      subjects will be randomized by blind draw into two groups: intervention group (IG) and
      placebo group (GII).

      The instruments that will be used for the evaluation are the visual analog pain scale, the
      Survey questionnaire for Temporomandibular Disorders (RDC) 3, and surface electromyography
      (EMG System of Brazil).

      The EMG signals will be collected in the rest position (3 samples) and maximum voluntary
      isometric contraction (3 collections). The masseter and temporalis muscles bilaterally will
      be evaluated according to the protocol of Rodrigues.

      For treatment of Ear, initially cleaning the pinna is made to be manipulated with 70% alcohol
      and later will be inserted mustard seed with a tape in the following points: Shenmen,
      Sympathetic, Kidney, subcortex, Adrenal and Brain second Souza in GI and GII point of the
      trachea. Such treatment will last 15 minutes each session, being held 2 times a week,
      alternating the ear to be manipulated over a period of 5 weeks.

      For comparison between groups the Mann-Whitney test statistic with Software BioStat 4.0
      software will be used. With a significance level (p <0.05).
    

Intervention name(s): Auriculotherapy
Intervention type(s): Other
Intervention description(s): First cleaning of the ear is made with 70% alcohol. The seed will be stuck in the ear with an adhesive (Micropore 3M) tape. The placement, points according to Souza (1997), were: Shen Men, Sympathetic, Kidney, Subcortex, Adrenal and Cerebral. As sessions will held twice a week for a total of 10 sessions.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Pain Therapy After Elective Cardiac Surgery
Condition: Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine generation of a target controlled infusion model
      for the patient controlled analgesia with the strong analgesic, hydromorphone, after planned
      open heart surgery, during which the strong analgesic, sufentanil, was used.
    


Intervention name(s): Sufentanil, Hydromorphone; Sufentanil, Hydromorphone
Intervention type(s): Drug; Drug
Intervention description(s): Intraoperatively: Target controlled infusion with 0.4 ng/ml Sufentanil, Postoperatively: Patient-controlled analgesia with target-controlled infusion of Hydromorphone; Intraoperatively: Target controlled infusion with 0.8 ng/ml Sufentanil, Postoperatively: Patient-controlled analgesia with target-controlled infusion of Hydromorphone
Intervention MeSH terms: Sufentanil; Dsuvia; Hydromorphone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Pharmacokinetic-pharmacodynamic modeling; Patient-controlled analgesia; Target-controlled infusion; Hydromorphone; Sufentanil; after thoracotomy; cardiac surgery
Relative Bioavailability of Dabigatran and Digoxin in Healthy Male and Female Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate the bioavailability of dabigatran with and without concomitant administration
      of digoxin and the bioavailability of digoxin with and without concomitant administration of
      dabigatran etexilate
    


Intervention name(s): Dabigatran etexilate; Digoxin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Digoxin; Dabigatran
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Ruminant Trans Fats and the Risk of Cardiovascular Disease in Women
Condition: Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      While the deleterious effects of trans fat from industrial sources (iTFA) on cardiovascular
      health are well established, the impact of TFA from ruminants (rTFA) on cardiovascular risk
      factors has not been as well characterized. We have previously shown in men that a very high
      dietary intakes of rTFA (>3.5% of energy) leads to unfavourable changes in lipid
      cardiovascular risk factors that are similar to those seen with iTFA. However, our data also
      indicated that achievable intakes of rTFA that remain well above the current human
      consumption (1.5% of energy intake) had neutral effects on plasma lipids and other
      cardiovascular disease (CVD) risk factors in men. Other studies have also suggested that the
      LDL and HDL response to very high dietary intakes of rTFA (>5% of energy) in women may be
      different than in men.

      The general objective of the study is to investigate for the first time in a double-blind
      randomized controlled study the impact of high but yet achievable intake of ruminant trans
      fatty acids on plasma LDL-Cholesterol and other risk factors for CVD in healthy women.
    

Detailed description: 
      Ruminant trans fatty acids (rTFA) will come from an experimental butter formulated from dairy
      fat obtained after having modified the regimen of lactating cows. All diets will be identical
      in terms of menus, calories and macronutrient composition with the exception of TFA levels.
      All foods will be provided to study participants. Based on a 2500 kcal/day regimen, an intake
      of 4.1g of rTFA will represent 37 kcal/day (1.5% of energy intake) while the intake of 0.7 g
      of rTFA in the control diet will represent 6 calories (0.3% of energy). The 2 experimental
      diets will be formulated so that the percentage of daily calories from fat (33%),
      carbohydrates (52%) and proteins (15%) will meet the dietary recommendations of the American
      Heart Association and the NCEP for primary prevention of CVD.
    

Intervention name(s): isocaloric for week diet
Intervention type(s): Other
Intervention description(s): Consumption of the 2 experimental diets
a diet rich in ruminant trans fatty acids (4.1 g/2500 kcal);
a control diet (minimal dietary ruminant trans fatty acids, 0.7 g/2500 kcal).
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Cardiovascular disease; Trans fatty acids; Ruminant; Blood lipids; Lipoproteins; Women