bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Evaluate the Bioavailability, Food Effect and Pharmacokinetics of Deuremidevir Hydrobromide for Suspension
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is divided into three parts: bioavailability study (hereinafter referred to as "BA
      study"), food effect study (hereinafter referred to as "FE study") and pharmacokinetic
      characteristics study (hereinafter referred to as "PK characteristics study"). A total of 38
      subjects are planned to be enrolled. The three parts of the study can be carried out
      simultaneously, and there is no order requirement. The subjects will be assigned to one of
      them according to the enrollment order. Dose selection is 100mg, 300mg and 25mg.
    

Detailed description: 
      BA study plan included 18 subjects, in the form of dry suspension and tablets, with a dose of
      100 mg. Subjects were randomly divided into two sequences, TR and RT, with 9 cases in each
      sequence. They were given once in fasted condition each period, and the dry suspension and
      tablets were designed in a double crossover way.

      12 subjects were enrolled in the FE study plan, and the dose was 300mg in dry suspension.
      Subjects were randomly divided into two sequences, sequence 1 and sequence 2, with 6 cases in
      each sequence, and given once per period. Fasting and infant formula milk double crossover
      were tested in two periods according to the administration sequence.

      PK study form is dry suspension, the doses are 25 mg, 100 mg, 300 mg, taken orally once in
      fasted condition. 8 subjects will be enrolled in the 25mg group. The 100 mg group used the
      data of 18 subjects with dry suspension in BA study, while the 300 mg group used the fasting
      condition data of 12 subjects with dry suspension in FE study. The 100 mg and 300 mg groups
      will not be enrolled separately.
    

Intervention name(s): Deuremidevir Hydrobromide for Suspension 100mg; Deuremidevir Hydrobromide for Suspension 300mg; Deuremidevir Hydrobromide for Suspension 25mg; Deuremidevir Hydrobromide tablets 100mg
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Take it with 240ml water in fasted condition.; Take it with water in fasted condition or after taking infant formula.; Take it with 240ml water on an empty stomach.; Take it with 240ml water in fasted condition.
Other intervention name(s): VV116; VV116; VV116; VV116
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: VV116-RSV; Bioavailability; Food effect; Pharmacokinetics
Use of Recombinant hCG to Prevent Breast Cancer in BRCA1 and BRCA2 Carriers
Condition: hCG; BRCA1 Mutation; BRCA2 Mutation
Study type: Interventional
Phase: Phase 4

Summary: 
      Specific aim: To establish the proof of principle that treatment of "high breast cancer risk"
      women with recombinant human chorionic gonadotropin (r-hCG) will change their breast
      epithelium's high risk genomic profile to one similar to that identified in women with a
      history of early full first term pregnancy.
    

Detailed description: 
      This study is based on the investigators preclinical data that have demonstrated that r-hCG
      exerts a mammary cancer preventive effect that is mediated by the induction of gland
      differentiation, which results in permanent changes in the genomic signature of this organ.
      This exploratory study will evaluate the genomic profile of breast epithelial cells obtained
      from random periareolar fine needle aspiration (RPFNA) specimens performed in high risk women
      treated for 90 days (an extra 4 weeks in a subgroup) with r-hCG. This knowledge will serve as
      the basis for establishing a novel genomic biomarker that will serve as a surrogate endpoint
      in future preventive clinical trials.

      The objective of the proposed study is to characterize the genomic profile of breast
      epithelial cells obtained from 35 asymptomatic high breast cancer risk nulliparous
      premenopausal women carriers of BRCA1 and BRCA2 deleterious mutations. Gene expression
      measurements and benign breast tissue specimens will be obtained at baseline (time 0), after
      treatment with r-hCG at 90 days (time 1), at 270 days from baseline (time 2) and (in a
      subgroup) at 60 weeks (+/- 4 weeks).

      The primary objective of the study is to compare the gene expression profiles of these women
      across the three (or four) time points and identify differentially expressed genes. The
      investigator is interested in comparing the expression profiles between all pairs of time
      points as well as across time. The comparison of profiles before and after treatment with
      r-hCG, both at 90 and 270 days are of particular interest. The women will receive 3x/week
      injections of 250 microgram r-hCG for a total of 12 weeks (an extra 4 weeks in a subgroup).
      Core Needle Biopsies specimens will be primarily utilized for analysis of genomic expression
      by cDNA microarray. In addition, a series of surrogate intermediate markers such as
      cytomorphologic evaluation and cell proliferation index will be analyzed.
    

Intervention name(s): Ovitrelle
Intervention type(s): Drug
Intervention description(s): Ovitrelle will be injected in 35 asymptomatic women with BRCA1 or BRCA2 mutation during 90 days (an extra 4 weeks in a subgroup). The gene expression of the breast epithelial cells will be characterized and compared to the gene expression of the breast epithelial cells before ovitrelle injection.
Intervention MeSH terms: Chorionic Gonadotropin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Ondansetron VS Doxylamine and Pyridoxine in Treating Nausea of Pregnancy
Condition: Vomiting of Pregnancy
MeSH terms: Nausea; Vomiting
Study type: Interventional

Summary: 
      Our purpose is to determine whether ondansetron, a commonly used antiemetic, is equivalent in
      efficacy to the combination of pyridoxine and doxylamine, the currently recommended first
      line therapy for nausea and vomiting in pregnancy by the American Congress of Obstetricians
      and Gynecologists (ACOG). Since both treatments are safe in pregnancy, many physicians are
      using ondansetron as first line in practice. Despite this practice and the recommendations
      from ACOG, there is not data to suggest that ether practice is superior. This will be the
      first prospective, randomized, double blind, controlled trial comparing the two treatments.
      We hypothesize that ondansetron will be equally efficacious in reducing nausea and episodes
      of emesis. By alleviating nausea and vomiting associated with pregnancy, patients will likely
      benefit from less Emergency Department visits, urgent clinic visits, and admissions for
      progression to hyperemesis gravidarum.
    


Intervention name(s): Ondansetron
Intervention type(s): Drug
Intervention description(s): Ondansetron 4mg and a placebo capsule to be taken orally every 8 hours for 5 days.
Other intervention name(s): Zofran
Intervention MeSH terms: Ondansetron
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: nausea; vomiting; pregnancy; ondansetron; doxylamine; vitamin B6; pyridoxine
The Effect of Neuro-orthosis on Gait Performer in Post Stroke Subjects
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      The aim of this study is to verify the effectiveness of foot drop stimulation (FDS) on gait
      rehabilitation of post-stroke subjects with mild, moderate and severe compromise.
    

Detailed description: 
      The stroke subjects are going to perform the walking training with Foot drop stimulator on
      the treadmill. All the evaluations will be performed with a foot drop stimulator turned off
      and on. One month later, that finished the intensive treatment; the participants were also
      evaluated only without the stimulation of FDS.
    

Intervention name(s): Foot Drop Stimulator - Neuro Orthosis; Treadmill
Intervention type(s): Device; Device
Intervention description(s): The WalkAide system is a self-contained functional electrical stimulation device with a built-in tilt sensor and attaches with a cuff to the leg below the knee. The device stimulates the peroneal nerve provides active dorsiflexion of muscle during the swing phase of gait.; Gait training on a treadmill
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cerebrovascular Stroke; Cerebral Stroke; Cerebrovascular Accident; Neurorehabilitation; Gait Rehabilitation
Mass Continous Suture With PDS Versus Interrupted Suture With Thread on Major Abdominal Incision
Condition: Surgical Wound; Suture, Complication
MeSH terms: Surgical Wound
Study type: Interventional

Summary: 
      A better suture technology will reduce postoperative incision complications. This study is
      designed to compare mass continous suture with PDS and interrupted suture with thread on
      major abdominal incision.
    

Detailed description: 
      A better suture technology will reduce postoperative incision complications. The previous
      retrospective cohort study from the investigator has demonstrated that continuous mass suture
      with PDS led to shorter incision closure time, early wound healing and comparable incisional
      complications versus interrupted thread suture. As such, the current RCT study will include
      100 subjects with major abdominal incision. They will be divided into two groups randomly:
      Mass suture gorup, mass continuous suture with PDS, Control group, interrupted suture with
      thread. The wound healing time, stitches removal time and incidence of incision complications
      will be compared between the two groups.
    

Intervention name(s): Mass continous suture with PDS; Interrupted suture with thread
Intervention type(s): Procedure; Procedure
Intervention description(s): The surgical incision will be treated by mass continous suture with PDS.; The surgical incision will be treated by interrupted suture with thread.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Surgical Wound; Suture, Complication
SERETIDE 100/50 bd (Twice Daily) Versus FLIXOTIDE 100 bd As Initial Maintenance Therapy In Moderate Asthma In Adults
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will compare during 12 weeks, two treatment strategies for Initial Maintenance
      Therapy : fluticasone propionate alone or the salmeterol/fluticasone propionate combination
      in adults with moderate persistent asthma
    

Detailed description: 
      A multicentre randomised, double-blind, parallel-group study to compare the
      salmeterol/fluticasone propionate combination (SERETIDETM DISKUSTM 50/100) 50/100µg one
      inhalation twice daily with fluticasone propionate (FLIXOTIDETM DISKUSTM 100) 100µg one
      inhalation twice daily as initial maintenance therapy for 12 weeks in adults with persistent
      moderate asthma
    

Intervention name(s): Salmeterol xinafoate/fluticasone propionate combination; Fluticasone propionate
Intervention type(s): Drug; Drug
Intervention description(s): SFC 100; FP 100
Other intervention name(s): SERETIDE FLIXOTIDE
Intervention MeSH terms: Fluticasone; Xhance; Salmeterol Xinafoate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: persistent; moderate; asthma; adults; Initial; Maintenance; Therapy
Single Dose Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Study Of PF-06291874 In Healthy Adult Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this trial is to evaluate the safety and tolerability,
      pharmacokinetics, and pharmacodynamics of single oral doses of PF-06291874 in healthy
      volunteers.
    


Intervention name(s): PF-06291874; placebo
Intervention type(s): Drug; Other
Intervention description(s): PF-06291874 will be administered as an extemporaneously prepared suspension for all doses within the initially planned range of 75 mg to 500 mg.; Correspondingly, placebo doses will be administered as suspension.
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: T2DM; Diabetes Mellitus Type 2
Evaluation of SPN-812 (Viloxazine Extended-release Capsule) High Dose in Adolescents With ADHD
Condition: ADHD
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the efficacy and safety of high doses of SPN-812 in adolescents
      (12-17 years old) with ADHD
    

Detailed description: 
      This is a multicenter, randomized, double-blind, placebo-controlled, 3-arm, parallel-group
      study to assess the efficacy and safety of SPN-812 as a monotherapy for the treatment of
      adolescents 12-17 years old with ADHD.
    

Intervention name(s): Placebo; 400mg SPN-812; 600mg SPN-812
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Placebo was administered once daily; 400mg SPN-812 was administered once daily and compared to Placebo; 600mg SPN-812 was administered once daily and compared to Placebo
Other intervention name(s): PBO; SPN-812; SPN-812
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Drug Interaction Study Between Bosutinib And Aprepitant In Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open label, randomized, single dose, one cohort, two sequence, two period
      crossover study in healthy subjects. The primary objective of the study is to evaluate the
      effect of a single oral dose of aprepitant on the pharmacokinetic (PK) profile of a single
      oral dose of bosutinib in healthy subjects.
    


Intervention name(s): bosutinib or bosutinib + aprepitant
Intervention type(s): Drug
Intervention description(s): Single dose of bosutinib (500 mg) or single dose of bosutinib (500 mg) and aprepitant (125 mg)
Intervention MeSH terms: Aprepitant
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: bosutinib; aprepitant; drug interaction; healthy volunteers; pharmacokinetics; chronic myelogenous leukemia
Innovation of Breakfast Cereals and Snacks for Control of Appetite and Post-Prandial Glycemia
Condition: Obesity; Diabetes
Study type: Interventional

Summary: 
      The goal of the proposed research is to investigate the effects of novel snack products
      differing in macronutrient composition, fibre and sugar content on post-prandial glycemia and
      short-term appetite control in healthy adults.
    


Intervention name(s): Dietary intervention
Intervention type(s): Other
Intervention description(s): All arms are given to all participants, in a randomized order
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Satiety; Food intake; Breakfast cereals/snacks; Postprandial glycemia
Palonosetron and Hydroxyzine to Reduce Opioid Withdrawal
Condition: Substance-Related Disorders
MeSH terms: Substance-Related Disorders
Study type: Interventional

Summary: 
      Opioid medications are commonly used for pain relief. When given over time, physical
      dependence can occur. This results in unpleasant side effects--such as agitation and
      nausea--if opioid medications are suddenly stopped. We are interested in knowing if a
      medication named Ondansetron can help ease or prevent symptoms associated with opioid
      withdrawal. We are also interested in knowing if a similar (but more potent FDA-approved
      drug, palonosetron) can more effectively treat withdrawal symptoms with or without
      combination with an antihistamine called hydroxyzine (vistaril).
    

Detailed description: 
      We hope to learn if Palonosetron and/or combination with hydroxyzine can be used to prevent
      or attenuate the signs and symptoms of opioid withdrawal. If we find that it can help prevent
      these symptoms, it may become a new treatment that can aid patients suffering from these
      symptoms.
    

Intervention name(s): Palonosetron; Hydroxyzine; Placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): Over 3 study visits, patients will receive one of the following treatment regimens:
Placebo saline IV and sugar pill
0.75 mg Palonosetron IV and sugar pill
0.75 mg Palonosetron IV and 100 mg hydroxyzine PO; Over 3 study visits, patients will receive one of the following treatment regimens:
Placebo saline IV and sugar pill
0.75 mg Palonosetron IV and sugar pill
0.75 mg Palonosetron IV and 100 mg hydroxyzine PO; Over 3 study visits, patients will receive one of the following treatment regimens:
Placebo saline IV and sugar pill
0.75 mg Palonosetron IV and sugar pill
0.75 mg Palonosetron IV and 100 mg hydroxyzine PO
Other intervention name(s): Aloxi; Vistaril, Atarax
Intervention MeSH terms: Palonosetron; Hydroxyzine
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: There were three treatment arms to the study: Placebo, Palonosetron, and Palonosetron + Hydroxyzine (Combo). Participants were not randomized in between these arms, all participants completed each arm of the study in a cross-over study methodology (Placebo, Palonosetron, Palonosetron + Hydroxyzene (combo). Participants were individually randomized into the order in which they participated in each arm.
Per sequence each individual participant underwent the following randomization schedule:
Participant 1: Placebo, Combo, Palonosetron Participant 2: Palonosetron, Combo, Placebo Participant 3: Palonosetron, Combo, Placebo Participant 4: Combo, Placebo, Palonosetron Participant 5: Placebo, Palonosetron, Combo Participant 6: Combo, Palonosetron, Placebo Participant 7: Combo, Placebo, Palonosetron Participant 8: Combo, Palonosetron, Placebo Participant 9: Palonosetron, Placebo, Combo Participant 10: Placebo, Combo, Palonosetron
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Palonosetron; Hydroxyzine; Acute opioid withdrawal
Three-dimensional Assessment of the Bone Changes Accompanying Laser-assisted Orthodontic Tooth Movement
Condition: Low Level Laser Therapy; Canine Retraction; Orthodontic Tooth Movement
Study type: Interventional

Summary: 
      Aim of the present study is to evaluate the effect of low-level laser therapy on bone quality
      and quantity with orthodontic tooth movement.
    


Intervention name(s): Low level laser therapy; without beam emission
Intervention type(s): Radiation; Other
Intervention description(s): The low-level laser applied will be a Diode laser* emitting infrared radiation at a wavelength of 980 nm, in a continuous mode. On the experimental side, subjects will receive LLLT on days 0, 3, 7, 14, and every 2 weeks thereafter, till the termination of the study period (3 months).; The laser tip will be held passively on the control side without beam emission, providing a placebo effect.
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: The study is a randomized controlled clinical trial, involving the split-mouth design, with one side of the maxillary arch serving as the control group, and the other side serving as the experimental group.
Masking: Single (Participant)
Primary purpose: Other
A Control Study to Evaluate The Efficacy And Safety of Ozone-therapy in Chronic Hepatitis B
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to investigate the efficacy and safety of medical ozone in
      treatment of chronic hepatitis B patients.
    

Detailed description: 
      Total of 439 patients with chronic hepatitis B were divided according to patients' intention
      into two arms. 173 patients in arm I were treated with medical ozone therapy with humares
      which was made in Germany for at least 12 weeks.266 patients in arm II were treated with
      conventional interferon-α for at least 24 weeks.Patients in both groups were followed-up for
      24 weeks.Virology response, biochemistry response and hepatitis B viral serological response
      will be studied at 12 weeks after the treatment, at the end of treatment and after 24 weeks
      of follow-up.
    

Intervention name(s): medical ozone therapy with humares; conventional interferon-α
Intervention type(s): Device; Drug
Intervention description(s): Medical ozone therapy with instrument made in Germany Patients in this group will receive autohemotherapy treatment. First month: ozone concentration: 20µg ~40µg /ml;The second month: 30µg/ml × 100ml oxygen- ozone gas × 100 ml blood;The third month: 20µg/ml × 100ml oxygen- ozone gas× 100 ml blood.; Patients in the conventional interferon-α treatment group received subcutaneouslly injection of 5 million units of conventional interferon-α in three times per week for at least 24 weeks.
Other intervention name(s): ozone instrument made in Germany: Humares
Intervention MeSH terms: Interferons
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic hepatitis B; Medical Ozone; Interferon-α; Efficacy