bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Rifampin on the Pharmacokinetics of Ataluren
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be a single centre, Phase I, open-label, one cohort, one dose level,
      fixed-sequence, drug interaction study in healthy volunteers. The objective of this study is
      to determine the effects of rifampin on the pharmacokinetics of ataluren under fasting
      conditions.
    

Detailed description: 
      A total of 15 healthy, adult, male non-smokers, were included in this study. Subjects were
      administered ataluren on Day 1 followed by rifampin from Days 3 to12, and again ataluren on
      Day 11. On Day 11, ataluren was administered before rifampin administration.

      Prior to entering the trial, subjects had a screening visit to establish eligibility within
      28 days before study drug administration. Subjects were confined from at least10 hours before
      the first ataluren dosing on Day 1 until approximately 50 hours postdose(Day 3). Thereafter,
      subjects came back every morning from Days 4 to 10 for rifampin dosing. Then, subjects
      reported to the clinical site at least 10 hours before ataluren dosing on Day 11 (evening of
      Day 10) and remained in the clinical site until after 50 hours post-Day 11 ataluren dose (Day
      13).
    

Intervention name(s): Ataluren; Rifampin
Intervention type(s): Drug; Drug
Intervention description(s): Powder for oral suspension (supplied in sachets) 1X 125 mg + 1 x 250 mg + 1000 mg (total of 1375 mg); Capsule 2x3oo mg Oral
Other intervention name(s): Ataluren(PTC124); Rifadin®
Intervention MeSH terms: Rifampin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Drug-drug interaction
A Target Occupancy Study With Ritlecitinib.
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase 1, open label, two-arm study to assess target occupancy and functional
      inhibition of JAK3 and TEC kinases by Ritlecitinib in healthy adult participants
    


Intervention name(s): Ritlecitinib 50 mg; Ritlecitinib 200 mg
Intervention type(s): Drug; Drug
Intervention description(s): 50 mg single dose; 200 mg single dose
Other intervention name(s): PF-06651600; PF-06651600
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
The Effect of Cold Therapy on Pain and Anxiety During the Implanted Port Catheter Removal
Condition: Pain; Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      This study was conducted as a quasi-experimental study to examine the effect of cold therapy
      on pain and anxiety during venous port catheter removal.
    

Detailed description: 
      Pain and anxiety experienced during diagnosis and treatment in cancer patients affect the
      physical, psychological, and interpersonal well-being of individuals and affect their lives
      in all aspects. Nurses play a very important role in pain control. Pain control is very
      important in terms of ensuring the comfort of patients and increasing their quality of life.
      In order to provide this control; nurses can use non-pharmacological treatment methods that
      they can apply independently in pain management. Patients experience procedural pain during
      insertion and removal of an implantable port catheter, which is one of the painful invasive
      procedures that are placed under the skin with a small incision, and insertion of a needle
      into the port catheter. When the literature is examined, it is seen that there are a limited
      number of studies in which non-pharmacological methods are used in the control of pain and
      anxiety related to the implantable venous port catheter procedure, and in these studies,
      distraction, music therapy, and inhaler aromatherapy. However, no study was found in which
      cold application was used to reduce the pain and anxiety caused by the removal of the port
      catheter in cancer patients. Therefore, the aim of the study is to evaluate the effectiveness
      of cold application on procedural pain and anxiety associated with port catheter removal,
      which is frequently used in the treatment of cancer patients. Cold therapy as an independent
      nursing intervention in reducing anxiety and pain management during port catheter removal in
      cancer/oncology patients; can be transferred to clinical practice by oncology nurses,
      improving the quality of nursing care, ensuring patient safety, and increasing patient
      satisfaction. In addition, the results of the research may contribute to the literature in
      terms of increasing evidence-based information on the use of the cold application in
      procedural pain and anxiety control in cancer patients.
    

Intervention name(s): cold therapy application
Intervention type(s): Other
Intervention description(s): cold therapy
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel Assignment a clinical trial with experimental and control groups with
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Cancer; Venous Port Catheter; Cold Therapy; Pain; Anxiety
A Study of BCI-838 and Several BCI-632 Prodrugs in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the safety, tolerability and pharmacokinetics of BCI-838, its
      metabolite BCI-632 and several new pro-drugs in healthy male subjects.
    

Detailed description: 
      The first phase of this study will evaluate the safety and tolerability of BCI-838 following
      oral administration of single doses of BCI-838 in healthy male subjects. The pharmacokinetics
      of BCI-838 and its metabolite BCI-632 following single ascending doses of BCI-838 will be
      evaluated, as will the effect of food on the pharmacokinetics of BCI-838 and its metabolite
      following single oral doses of BCI-838 in healthy male subjects.

      The second phase of this study will evaluate and compare the relative bioavailability and PK
      of the metabolite BCI-632 following single oral administration of several new pro-drug
      candidates in healthy male subjects.
    

Intervention name(s): BCI-838; BCI-838; BCI-1038, BCI-1206 & BCI-1283; BCI-838
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): BCI-838 100 mg and 300 mg or matching placebo administered as single oral doses under fasted conditions in a sequential design; BCI-838 administered as a single 30 mg oral dose or matching placebo under fasted and fed conditions in a crossover design; Three new pro-drugs administered as a 1 mg single oral doses under fasted conditions in a sequential design; BCI-838 900 mg or matching placebo administered as a single oral dose under fasted conditions
Intervention MeSH terms: BCI-838
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: metabotropic glutamate receptors 2 and 3; antagonist; mGluR; ketamine; BDNF; Depression; Major Depressive Disorder; Mood Disorder; Treatment Resistant Depression; Phase 1 safety, tolerability and pharmacokinetics study
Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous and Subcutaneous Single and Repeated Doses of SAR441344 in Healthy Adult Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary Objective is the tolerability and safety of ascending single and repeated intravenous
      infusion (IV) and/or subcutaneous (SC) administration of SAR441344
    

Detailed description: 
      The study duration of Part 1 is approximately 22 weeks, including a treatment period of 1
      day; The study duration of Part 2 is approximately 26 weeks for each subject, including a
      treatment period of 29 days.
    

Intervention name(s): SAR441344; placebo; Keyhole limpet hemocyanin
Intervention type(s): Drug; Drug; Biological
Intervention description(s): Solution for intravenous/subcutaneous injection; Solution for intravenous/subcutaneous injection; Subcutaneous Lyophilized powder for reconstitution
Intervention MeSH terms: Keyhole-limpet hemocyanin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Revlimid Dose 25 mg in Association With (R-CHOP) in the Treatment Follicular Lymphoma
Condition: Follicular Lymphoma
MeSH terms: Lymphoma; Lymphoma, Follicular
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to assess the efficacy of the association of Lenalidomide
      (Revlimid) and R-CHOP (Rituximab, Cyclophosphamide, Doxorubicin, vincristine and Prednisone)
      in a population of patients with follicular lymphoma as measured by the response rate at the
      end of treatment.
    


Intervention name(s): Lenalidomide and R-CHOP
Intervention type(s): Drug
Intervention description(s): Lenalidomide dose administered orally during 14 days in combination with 6 courses of fixed doses of R-CHOP 21.
Other intervention name(s): R2-CHOP2
Intervention MeSH terms: Lenalidomide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Meropenem Plasma Concentration Measurements at the Pediatric Medical Ward, Oslo University Hospital, Rikshospitalet
Condition: Bacterial Infection
MeSH terms: Bacterial Infections
Study type: Observational

Summary: 
      The object of the study is to investigate whether all included patients receive treatment
      that is effective against all bacteria that are defined as sensitive to meropenem with the
      current treatment regimen. Will the investigators findings motivate routine monitoring of
      plasma concentrations in children receiving meropenem? Up to 50 patients will be included in
      the study, and all participants are children.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients at the Pediatric medical ward.
      
Biospecimen description: 
      Two blood samples are taken from each included patient. (Each 2 ml heparin full blood).
    
Keywords: meropenem; child; bacterial infection; treatment evaluation
Correlation of Menstrual Cycle Phase at Time of Primary Surgery With 5-Year Disease-Free Survival in Women With Stage I or Stage II Breast Cancer
Condition: Breast Cancer; Perioperative/Postoperative Complications
MeSH terms: Breast Neoplasms; Postoperative Complications
Study type: Observational

Summary: 
      RATIONALE: Timing of breast cancer surgery may improve effectiveness of treatment and may
      help patients live longer.

      PURPOSE: Clinical trial to determine whether timing of primary surgery in relation to
      menstrual cycle is associated with disease-free survival 5 years after surgery in women who
      have stage I or stage II breast cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Document menstrual phase (follicular vs luteal) by circulating hormones and menstrual
           history at the time of primary surgery in premenopausal women with stage I or II breast
           cancer.

        -  Correlate menstrual phase at primary surgery with 5-year disease-free survival in these
           patients.

        -  Compare the menstrual cycle data obtained by hormone levels and study-specific menstrual
           cycle history with information recorded in the general written record.

        -  Compare the menstrual cycle data (e.g., hormone levels and cycle history) for these
           women with the data for the general population.

        -  Estimate the disease-free survival of women who undergo a 2-stage surgical procedure
           with cancer found at both stages when the surgery is not confined to the same menstrual
           cycle phase.

      Premenopausal women age 18 to 55 years, who were interviewed for menstrual history and who
      were surgically treated for stages I to II breast cancer, had serum drawn within 1 day of
      surgery for estradiol, progesterone, and luteinizing hormone levels. Menstrual history and
      hormone levels were used to determine menstrual phase: luteal, follicular, and other.
      Disease-free survival (DFS) and overall survival (OS) rates were determined by Kaplan-Meier
      method and were compared by using the log-rank test and Cox proportional hazard modeling.
    

Intervention name(s): patient interviewing to obtain menstrual history; blood sampling
Intervention type(s): Behavioral; Procedure
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        This trial enrolled premenopausal women age 18 to 55 years who had regular menstrual cycles
        of 21- to 35-days duration and pathologic stages I to II breast cancer, in whom all gross
        disease-including ductal carcinoma in situ-was surgically removed either in a one-stage or
        two-stage procedure.
      
Keywords: stage I breast cancer; stage II breast cancer; perioperative/postoperative complications
Fish Oils and Soybean Lecithin Supplementation Modulate Immune Function in Runners
Condition: Immune Dysfunction
MeSH terms: Immune System Diseases
Study type: Interventional

Summary: 
      The purpose of this study was evaluate the comparative effects of FO rich in EPA (FO-EPA) and
      FO rich in DHA (FO-DHA) on inflammation and neutrophil properties after a prolonged and
      strenuous exercise. The effect of soybean lecithin on the same parameters and conditions also
      was evaluated.
    

Detailed description: 
      The volunteers were not taking any medication during the study. All individuals signed an
      informed consent form to the study protocol. Both experimental procedure and informed consent
      form of this study were in accordance with Guide for the Care and Use of Humans.

      All volunteers performed two half-marathons. In the first half-marathon, all participants
      were not supplemented. Dietary supplementation was initiated immediately after the first
      race. The volunteers were randomly separated into 3 groups: Soybean lecithin group; Fish
      oil-DHA group and Fish oil-EPA group. The volunteers ingested 3 g daily of SL or FO-DHA
      containing 1.5 g DHA and 0.3 g EPA or FO-EPA containing 1.6 g EPA and 0.3 g DHA (EPA:DHA =
      5.4:1) during 60 days.

      Experimental design:

      First race - not supplemented, blood samples were collected before (Phase I) and immediately
      after race (Phase II).

      Second race - dietary supplemented, blood samples were collected before (Phase III) and
      immediately after the race (Phase IV).

      Results were analyzed by two-way analysis of variance (two-way ANOVA) and Tukey post-hoc
      test. The statistical analysis of the half-marathon effect was performed using nonparametric
      t tests. Results were considered statistically significant for P<0.05.
    

Intervention name(s): dietary supplementation; Exercise
Intervention type(s): Dietary Supplement; Other
Intervention description(s): The volunteers ingested 3 g daily of Soybean lecithin or fish oil rich in docosa-hexanoic acid (DHA) containing 1.5 g DHA and 0.3 g EPA (DHA:EPA = 5:1) or fish oil rich in eicosapentaenoic acid (EPA) containing 1.6 g EPA and 0.3 g DHA (EPA:DHA = 5.4:1) during 60 days.; All volunteers performed two half-marathons. In the first half-marathon, all participants were not supplemented. In the second half-marathon, all participants were supplemented. Blood samples were collected before and after both half-marathon race.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: strenuous exercise; dietary supplementation; immune system; leucocyte function; inflammation
First-in-Human Single and Multiple Dose of GLPG1690
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this First-in-Human study is to evaluate the safety and tolerability after
      single ascending oral doses of GLPG1690 given to healthy male subjects, compared to placebo.
      Also, the safety and tolerability of multiple ascending oral doses of GLPG1690 given to
      healthy male subjects daily for 14 days compared to placebo, will be evaluated.

      Furthermore, during the course of the study after single and multiple oral dose
      administrations, the amount of GLPG1690 present in the blood and urine (pharmacokinetics) as
      well as the reduction of biomarker levels by GLPG1690 in plasma samples (pharmacodynamics)
      will be characterized compared to placebo.

      The pharmacokinetics of a solid dosage formulation of GLPG1690 will be compared with those of
      a liquid dosage formulation of GLPG1690.

      Also, the potential of cytochrome P450 (CYP)3A4 induction after repeated dosing with GLPG1690
      will be explored.
    


Intervention name(s): GLPG1690 single ascending doses; Placebo single ascending doses; GLPG1690, multiple ascending doses, oral suspension; Placebo, multiple ascending doses, oral suspension
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Single dose, oral suspension or solid formulation, starting dose of 20mg escalating up to 1500mg; Single dose, oral suspension or solid formulation matching placebo; Multiple doses, daily for 14 days, oral suspension, anticipated doses: 300mg to 1000mg; Multiple doses, daily for 14 days, oral suspension matching placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Extension Study of ABP-19000 to Evaluate Safety and Efficacy of Repeat Treatments of ABP-450 in Cervical Dystonia
Condition: Cervical Dystonia
MeSH terms: Dystonia; Dystonic Disorders; Torticollis
Study type: Interventional
Phase: Phase 2

Summary: 
      This Open-label Extension trial will evaluate the safety and efficacy of ABP-450 for the
      treatment of cervical dystonia in adults. The study will enroll 60 patients across
      approximately 42 sites in the United States from Phase 2 (ABP-19000) and Phase 3 (ABP-19001)
      trials and 29 sites in Europe from Phase 3 (ABP-19001) trial. Study subjects who had their
      initial dose of study drug in Phase 2 or Phase 3 trial studies, irrespective of treatment
      allocation, will be eligible to enroll in this OLE study.
    

Detailed description: 
      This Open-label Extension trial will evaluate the safety and efficacy of ABP-450 for the
      treatment of cervical dystonia in adults. The study will enroll 60 patients across
      approximately 42 sites in the United States from Phase 2 (ABP-19000) and Phase 3 (ABP-19001)
      trials and 29 sites in Europe from Phase 3 (ABP-19001) trial. Study subjects who had their
      initial dose of study drug in Phase 2 or Phase 3 trial studies, irrespective of treatment
      allocation, will be eligible to enroll in this OLE study. Study subjects will receive a
      predetermined dose of ABP-450 between the Low Dose and High Dose, based on the investigator's
      discretion and clinical judgment.
    

Intervention name(s): ABP-450
Intervention type(s): Drug
Intervention description(s): ABP-450 (prabotulinumtoxinA) contains a 900kDA botulinum toxin type-A complex produced by the bacterium Clostridium botulinum.
Other intervention name(s): prabotulinumtoxinA
Intervention model: Sequential Assignment
Intervention model description: Approximately 60 subjects from ABP-19000 or ABP-19001 studies, irrespective of treatment allocation, will have the option to continue treatment with ABP-450 via intramuscular injection into affected neck muscles.
Masking: None (Open Label)
Primary purpose: Treatment
Transcranial Direct Current Stimulation in Patients With Disorders of Consciousness
Condition: Vegetative State; Minimally Conscious State; Disorders of Consciousness
MeSH terms: Consciousness Disorders; Persistent Vegetative State
Study type: Interventional
Phase: Phase 2

Summary: 
      Previous studies showed that anodal transcranial direct current stimulation (tDCS) applied to
      the left dorsolateral prefrontal (DLPF) cortex transiently improves performance of memory and
      attention. Investigator assessed the effects of left DLPF-tDCS on Coma Recovery Scale-Revised
      (CRS-R) scores in severely brain damaged patients with disorders of consciousness in a
      double-blind sham-controlled experimental design.
    

Detailed description: 
      Following severe brain damage and coma, some patients may remain in a vegetative state (VS)
      or minimally conscious state (MCS). At present, there are no evidence-based guidelines
      regarding the treatment of patients with disorders of consciousness (DOC).

      Investigator aim to assess the effect of single session anodal (i.e., excitatory)
      transcranial direct current stimulation (tDCS) of the left dorsolateral prefrontal cortex
      (DLPF) on the level of consciousness in DOC patients in a double blind randomized sham
      controlled study.

      tDCS is a form of safe non-invasive cortical stimulation, modulating cortical excitability at
      stimulation sites via weak polarizing currents, previously reported to transiently improve
      working memory and attention by stimulating the left DLPF in healthy subjects and patients
      with stroke, Parkinson's or Alzheimer's disease.
    

Intervention name(s): Anodal tDCS; sham tDCS
Intervention type(s): Device; Device
Intervention description(s): patients received anodal tDCS (on PFDL cortex) during 20 minutes preceded and followed by a behavioral assessment (Coma Recovery Scale Revised); Patient received a sham tDCS (5sec of stimulation). The device runs during 20minutes and the anode was placed over the DLPF cortex. A behavioral assessment preceded and followed the stimulation.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: vegetative state; minimally conscious state; disorders of consciousness; transcranial direct current stimulation