bioihbjkbjnl/mcl2 huggingface dataset:
Effect of BIA 6-512 at Steady-state on the Levodopa Pharmacokinetics With a Single-dose of Levodopa/Benserazide 200/50 mg or With a Single-dose of Levodopa/Benserazide 200/50 mg Plus a Single-dose of Nebicapone 150 mg
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study was to determine whether the administration of BIA 6-512 (25 mg, 50
      mg, 75 mg and 100 mg) at steady-state affects the pharmacokinetics of levodopa when
      administered in combination with a single-dose of immediate release levodopa/benserazide
      200/50 mg or with a single-dose of immediate release levodopa/benserazide 200/50 mg plus a
      single-dose of nebicapone 150 mg.
    

Detailed description: 
      Single centre, double-blind, randomised, placebo-controlled, rising multiple dose study in
      four sequential groups of healthy male and female subjects. Eligible subjects were admitted
      to the Human Pharmacology Unit (UFH)on the day prior to receiving the first study medication.
      Starting in the morning of Day 1 (first dose), subjects received BIA 6-512/Placebo thrice
      daily until the morning of Day 5 (last dose). Concomitantly with the morning dose of BIA
      6-512/Placebo on Day 4, a levodopa/benserazide 200/50 mg (Madopar® 250) single-dose was
      administered. On Day 5, a Madopar® 250 single-dose and a nebicapone 150 mg single-dose were
      administered concomitantly with the morning dose of BIA 6-512/Placebo. In the morning of Day
      4 and Day 5, products were administered in fasting conditions of at least 8 hours and
      subjects remained fasted until 2 h post-dose. Subjects were resident in the UFH from
      admission (Day 0) until at least 24 h post last dose (Day 6); then, they were discharged and
      returned for the follow-up visit.
    

Intervention name(s): Placebo; BIA 6-512; Madopar® 250; Nebicapone
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Placebo capsules. Orally, with 240 mL of potable water.; The investigational products consisted of capsules containing BIA 6-512 25 mg, 50 mg, 75 mg, 100 mg. Orally, with 240 mL of potable water.; Levodopa/benserazide immediate release tablets 200mg/50mg. Orally, with 240 mL of potable water.; Nebicapone 150 mg tablets. Orally, with 240 mL of potable water.
Other intervention name(s): Trans-resveratrol; Levodopa/benserazide; BIA 3-202
Intervention MeSH terms: Levodopa; Benserazide; Resveratrol; Benserazide, levodopa drug combination
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Oxytocin MEG Study
Condition: Schizophrenia; Oxytocin; Magnetoencephalography (MEG); Social Cognition
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The specific aim of this proposal is to investigate the neurophysiological mechanisms of
      oxytocin's (OT) prosocial effects in patients with schizophrenia and healthy subjects using
      magnetoencephalography.

      Hypothesis A: When OT is administered to patients with schizophrenia, fear-related amygdala
      hyperreactivity and fusiform gyrus (FG) and anterior cingulate cortex (ACC) hypoactivity will
      be normalized.

      Hypothesis B: When OT is administered to patients with schizophrenia, the decreased
      functional connectivity (FC) between the amygdala, FG, and ACC will be normalized.

      By elucidating the neurophysiological mechanisms of OT administration on emotional face
      processing, investigators will bee able to:

        1. understand the pathophysiology of the functionally debilitating social cognitive
           deficits of schizophrenia,

        2. test the efficacy of OT in normalizing the neural abnormalities underlying these social
           deficits, and

        3. develop and optimize novel treatments for these currently untreatable deficits.
    


Intervention name(s): Oxytocin; Saline Nasal Spray
Intervention type(s): Drug; Drug
Intervention description(s): 40 IU of the oxytocin will be administered intranasally for a one time dose at the beginning of the visit.; 40 IU of the saline nasal spray will be administered once at the beginning of the visit.
Other intervention name(s): Syntocinon; Placebo
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Oxytocin; Syntocinon; Social Cognition; Schizophrenia; Magnetoencephalography (MEG)
A Study of Anti-Cancer Therapies Targeting the MAPK Pathway in Patients With Advanced NSCLC
Condition: Advanced Non-squamous Non-small-cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 1

Summary: 
      -  To evaluate the safety and tolerability of escalating doses of ERAS-007 or ERAS-601 in
           combination with other cancer therapies in study participants with advanced non-small
           cell lung cancer (NSCLC).

        -  To determine the Maximum Tolerated Dose (MTD) and/or Recommended Dose (RD) of ERAS-007
           or ERAS-601 administered in combination with other cancer therapies.

        -  To evaluate the antitumor activity of ERAS-007 or ERAS-601 in combination with other
           cancer therapies.

        -  To evaluate the PK profiles of ERAS-007 or ERAS-601 and other cancer therapies when
           administered in combination.
    

Detailed description: 
      This is a Phase 1b, open-label, multicenter master protocol evaluating safety, tolerability,
      and antitumor activity of ERAS-007 or ERAS-601 in combination with other cancer therapies in
      study participants with advanced NSCLC. The study will commence with the following dose
      escalation cohorts: ERAS-007 plus osimertinib in study participants with advanced NSCLC
      harboring epidermal growth factor receptor-sensitizing mutation(s) (EGFRm); ERAS-007 or
      ERAS-601 plus sotorasib in study participants with advanced NSCLC harboring Kirsten rat
      sarcoma G12C mutation (KRAS G12Cm). Dose expansion will follow and will evaluate ERAS-007 or
      ERAS-601 drug combinations administered at the RD identified from each respective dose
      escalation cohort in study participants with advanced EGFRm or KRAS G12Cm NSCLC.
    

Intervention name(s): ERAS-007; ERAS-601; Osimertinib; Sotorasib
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Administered orally; Administered orally; Administered orally; Administered orally
Other intervention name(s): Tagrisso; Lumakras
Intervention MeSH terms: Osimertinib; Sotorasib
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: EGFR; epidermal growth factor receptor; mutation; biomarker; NSCLC; Tagrisso; osimertinib; ERK; MAPK; sotorasib; Lumakras; KRAS; G12C; SHP2; PTPN11; molecular alterations; Kirsten rat sarcoma; Non-small cell lung cancer; Lung neoplasms; Thoracic neoplasms; ERAS-601; ERAS-007
Labial Frenulum Surgery - a Comparative Study of Conventional Scalpel and Er-Yag Laser Technique
Condition: Labial Tie
Study type: Interventional

Summary: 
      The aim of the study was to compare the outcome in terms of wound healing time, surgery time,
      bleeding and patient experience of the ectomy of frenulum when performed with laser
      technology versus conventional scalpel technique. A prospective, single-blind, randomized and
      controlled study was performed. Wound healing was assessed five and ten days after after
      surgery. The long-term outcome were assessed blinded by a dentist not earlier involved in the
      study.
    

Detailed description: 
      Children referred to a pediatric clinic to surgically remove a labial frenulum were
      randomized to treatment with conventional scalpel or laser treatment technology after parents
      and children had given consent to participate. During the surgery the time required for the
      procedure and the amount of bleeding the different techniques caused were measured. Wound
      healing was assessed five and ten days after surgery by a clinical judgement and by analysing
      photos. Three months after surgery an independent dentist assessed the long-term outcome by a
      clinical examination. The patients´ view of the treatment were assessed directly after the
      surgery and five days, ten days and three months after the surgery.
    

Intervention name(s): Scalpel; Er:YAG laser
Intervention type(s): Device; Device
Intervention description(s): Labial frenulum removed by scalpel; Labial frenulum removed by Er:YAG laser
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective, randomized, controlled, single-blind investigation
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: labial frenulum; surgery; scalpel technique; Er:YAG laser
Multiple Myeloma Treated With Thalidomide Before Autotransplant or With Conventional Chemotherapy and as Consolidation/Maintenance Treatment in Young and Elderly Patients : 3 Randomized Studies.
Condition: Multiple Myeloma de Novo Treatment
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of the study was to evaluate efficacy and tolerability of Thalidomide in first-line
      treatment of multiple myeloma as induction treatment in young patients, with Dexamethasone
      before autotransplant, and in elderly patients in combination with conventional chemotherapy
      and as consolidation/maintenance therapy in young and elderly patients at plateau-phase.
    

Detailed description: 
      MY-TAG : Thalidomide as induction treatment before high dose therapy, in young patients
      MY-DECT : Thalidomide as induction treatment with conventional chemotherapy, in elderly
      patients MY-PLAT : Thalidomide and Dexamethasone at plateau-phase, after high dose therapy or
      conventional chemotherapy
    

Intervention name(s): Thalidomide, Dexamethasone; Vincristin , Adriamycin, Dexamethasone = VAD; Thalidomide, melphalan, endoxan, dexamethasone (MCDex-Thal); melphalan, endoxan, dexamethasone (MCDex); Thalidomide, Dexamethasone
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Thalidomide 200 mg/d for 3 months, Dexamethasone 40 mg/d D1-D4 and D14-D17 for 28d-3 cycles; Vincristin 0.4 mg/d continUous IV infusion D1-D4, Adriamycin 9 mg/m2 continuous IV infusion D1-D4, Dexamethasone 40 mg/d oral D1-D4 and D15-D18 for 2 first cycles, D1-D4 for the 3d cycle; Thalidomide : 200 mg/d at bedtime for 3 months , melphalan: 6 mg/m2 oral D1-D4, endoxan 600 mg/m2 IV D1, dexamethasone 40 mg/d oral D1-D4 for 28-d 4 cycles; melphalan: 6 mg/m2 oral D1-D4, endoxan 600 mg/m2 IV D1, dexamethasone 40 mg/d oral D1-D4 for 28-d 4 cycles; Thalidomide 200 mg/d on every other 3 months Dexamethasone 40 mg/d D1-D4, D30-D34,D60-D64, D90-D94
Intervention MeSH terms: Thalidomide; Dexamethasone; Dexamethasone acetate; Doxorubicin; Liposomal doxorubicin; Melphalan; Cyclophosphamide; Vincristine; BB 1101
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: multiple myeloma, treatment, first line
To Evaluate Immunogenicity, Reactogenicity & Safety of 2 Doses of GSK Bio HRV Liquid Vaccine Given to Infants (Vietnam)
Condition: Infections, Rotavirus
MeSH terms: Rotavirus Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      To provide specific data on immunogenicity of GSK Biologicals' HRV liquid vaccine, when
      co-administered with the routine Expanded Program of Immunization (EPI) in Vietnam. The study
      will also assess reactogenicity and safety of the HRV liquid vaccine relative to the placebo
    


Intervention name(s): Human rotavirus liquid vaccine
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: Prophylaxis against gastroenteritis caused by Rotavirus
Randomized Control Trial of a Topical Anesthetic to Evaluate Pain and Anxiety During Venipuncture
Condition: Pain; Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the amount of anxiety and pain felt by children
      during procedures that require a needle stick after using a topical anesthetic or placebo
      cream.
    

Detailed description: 
      Pediatric patients frequently receive eutectic mixture of local anesthetics (EMLA) or other
      anesthetic medications prior to venipuncture. However, the time for the anesthetic to take
      affect is approximately 60 minutes. Another anesthetic medication besides EMLA is lidocaine
      4% topical anesthetic cream (LMX4), which has a shorter acting time (30 minutes) compared to
      the EMLA, making it a more desirable medication when urgent labs are required. This
      medication is being evaluated to assess the anxiety and pain associated with venipuncture in
      15 minutes versus the approved 30 minutes of pediatric patients treated as an inpatient or
      outpatient in the local Emergency Department, compared to standard care (no prior treatment).
    

Intervention name(s): 4% lidocaine topical anesthetic cream; Placebo cream
Intervention type(s): Drug; Drug
Intervention description(s): A dollop of 4% lidocaine cream was applied under occlusive dressing for 15 mins prior to venipuncture; A dollop of matching placebo cream was applied under occlusive dressing for 15 mins prior to venipuncture
Other intervention name(s): 4% liposomal lidocaine (Brand name = LMX4)
Intervention MeSH terms: Lidocaine; Anesthetics, Local; Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: pediatric patients; pain; anxiety; topical anesthetic; randomized control trial
Study Comparing Two Manufacturing Processes for Levonorgestrel 90 mg/Ethinyl Estradiol 20 mg (LNG/EE) in Healthy, Cycling Women
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary Objective: To determine the bioequivalence between the clinical batch process and the
      new processes for manufacturing LNG/EE.

      Secondary Objective: To obtain additional safety and tolerability data concerning LNG/EE in
      healthy, cycling women.
    


Intervention name(s): levonorgestrel/ethinyl estradiol
Intervention type(s): Drug
Intervention MeSH terms: Levonorgestrel; Ethinyl Estradiol; Estradiol
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: oral contraceptive; therapeutic equivalency; contraceptives, oral, combined
A Pilot Study: High Versus Low Oxytocin Dosing for Induction of Labor in Pregnant Patients With Obesity
Condition: Pregnant Patients With Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 4

Summary: 
      Pregnant patients with obesity are more likely to undergo induction of labor and have a
      higher risk of failed induction compared to patients with normal weight. The association
      between maternal obesity and labor dysfunction leading to cesarean delivery is poorly
      understood. Oxytocin is the mostly common medication used in induction of labor, yet optimal
      dosing of this medication is unknown. Studies have suggested that patients with obesity may
      be less responsive to oxytocin. This trial will compare a high and low dose oxytocin dosing
      regimen for the induction of labor in women with obesity.
    

Detailed description: 
      This study is a pragmatic single center randomized, double blinded controlled trial.
      Nulliparous women with a pre-pregnancy body mass index (BMI) ≥30 kg/m2 undergoing induction
      of labor at ≥37 weeks' gestation will be eligible for enrollment. Women will be randomly
      allocated to receive oxytocin using either a high-dose or low-dose regimen. Patients,
      providers, and research staff will be blinded to the dosing regimen. All other aspects of
      obstetric management will be at the discretion of the patient's clinical care team.

      Postpartum maternal, neonatal, and delivery outcomes will be collected. Postpartum data
      through hospital discharge will be collected from the medical record. Information about
      complications following hospital discharge through 6 weeks after delivery will be collected
      during a research follow-up telephone call performed 6-8 weeks following delivery.
    

Intervention name(s): High-dose oxytocin; Low-dose oxytocin
Intervention type(s): Drug; Drug
Intervention description(s): Starting dose 6 mU/min and increased by 6 mU/min every 30 minutes until adequate contractions achieved, at the discretion of the obstetric providers.; Starting dose 2 mU/min and increased by 2 mU/min every 30 minutes until adequate contractions achieved, at the discretion of the obstetric providers.
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Oxytocin; Pregnant patients with obesity; Induction of labor
Effects of Breathing Exercises on Reaction Time
Condition: Breathing, Mouth
MeSH terms: Respiratory Aspiration; Mouth Breathing
Study type: Interventional

Summary: 
      The aim of the study was to investigate the short and long-term effects of breathing
      exercises on reaction time.
    

Detailed description: 
      A total of 40 participants who volunteered to participate in the study from the students of
      the Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Bandırma
      Onyedi Eylül University will be included in the study. Participants will be randomly divided
      into two groups using a simple random numbers table. The study group (15 people) will be
      given respiratory exercises (12 sessions). The control group (15 people) will receive no
      intervention. In the study, after the demographic characteristics of the participants are
      obtained, reaction time will be evaluated with auditory and visual reaction tests and upper
      extremity reaction tests. All evaluations are planned to take a total of 15 minutes.

      The same assessments will be performed in both groups. To measure the long-term effect, after
      the initial evaluations are completed, the study group will be given a total of 12 sessions
      of breathing exercises for 4 weeks (3 days a week). After 4 weeks, both groups will be
      evaluated again. To measure the short-term effect, the respiratory exercise program will be
      started after the 1st evaluation in the study group, and the 2nd evaluation will be made
      after the first session.

      Canan Demir will perform breathing exercises, and the other researchers who will evaluate
      will not know which group the participants are in. In this way, the study will be
      single-blinded.

      Translated with www.DeepL.com/Translator (free version)
    

Intervention name(s): breathing exercises
Intervention type(s): Other
Intervention description(s): After the initial 5 minutes of relaxed breathing, the participants will perform diaphragmatic and costal breathing for 10 minutes. .5 diaphragmatic breathing will be done in 1 minute.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled, single-blind
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Other
Triggering of Final Oocyte Maturation With GnRHa (Buserelin) in GnRH Antagonist Cycles
Condition: OHSS (Ovarian Hyperstimulation)
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to possibly further improve the clinical outcome and explore the
      incidence of OHSS in patients, who have final oocyte maturation with GnRHa (Buserelin) in
      GnRH antagonist IVF/ICSI cycles
    


Intervention name(s): Buserelin and Pregnyl; Pregnyl; Buserelin and Pregnyl; Pregnyl
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Subcutaneous injection 0.5 mg and 1500 IU; Subcutaneous injection 5000 IU; Subcutaneous injection 0,5 mg and 1500 IU + 1500 IU after 7 days; Subcutaneous injection 5000 IU
Intervention MeSH terms: Chorionic Gonadotropin; Buserelin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: GnRH antagonist; GnRH agonist; hCG; OHSS; In vitro fertilization; ovulation induction; Clinical pregnancy rate
Pharmacokinetic Interactions Between an Herbal Medicine (African Potato) and Antiretroviral Agents (Lopinavir/Ritonavir)
Condition: Drug Interactions; Human Immunodeficiency Virus
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections; Immunologic Deficiency Syndromes
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is being conducted to evaluate whether African potato, an herbal medicine, can be
      used together with anti-HIV medicines without affecting the amounts of the anti-HIV medicines
      in the blood. African potato is an African herbal medicine widely used in Africa,
      particularly sub-Saharan Africa. Although it has not been proven, it is believed to help
      boost the immune system. Similar studies have been done on herbal medicines especially those
      that are used in developing countries. In some cases, the herbal treatments can affect the
      blood levels of other medicines when the medicines are used together. This study will measure
      the effect of African potato on lopinavir/ritonavir (Kaletra®), a common anti-HIV medicine.
      Lopinavir/ritonavir is approved by the United States Food and Drug Administration (FDA). The
      information obtained from this study will tell us if African potato and anti-HIV treatments
      can be used together to treat HIV infected patients in Africa and other resource poor
      regions.
    


Intervention name(s): Kaletra (lopinavir/ritonavir), African Potato (hypoxis obtusa)
Intervention type(s): Drug
Intervention description(s): The baseline PK of LPV/r will be established after 14 days of taking LPV/r at a dose of 400/100 mg twice daily. This will be followed by a 7 day course of LPV/r and AP together. The AP dose to be administered will be 15 mg/kg/day of hypoxoside.
Intervention MeSH terms: Ritonavir; Lopinavir
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Herbal medicine; African Potato; Hypoxis obtusa; Drug interaction; HIV Infections; Acquired Immunodeficiency Syndrome; Healthy Subjects; Anti-retroviral Agents; Lopinavir; Ritonavir