bioihbjkbjnl/mcl2 huggingface dataset:
Jing Si Herbal Tea for Long-Coronavirus Disease(COVID) Gut-brain Interaction
Condition: Healthy Subjects; COVID-19 Pneumonia; Irritable Bowel Syndrome; Functional Gastrointestinal Disorders
MeSH terms: Irritable Bowel Syndrome; Gastrointestinal Diseases; Digestive System Diseases
Study type: Interventional

Summary: 
      Dyspepsia refers to chronic or recurrent upper gastrointestinal symptoms. According to the
      Rome IV criteria, functional dyspepsia (FD) symptoms included meal related fullness, early
      satiation, epigastric pain or burning which are unexpl ained after routine investigation. FD
      causes substantial psychophysical burden because of its unknown etiology and high prevalence.
      Although FD is currently associated with local inflammation of the gastrointestinal tract and
      microbiota alteration, current available treatments for FD are of limited effectiveness. In
      view of this, many studies have applied Chinese herbal medicine in FD and achieved some
      therapeutic benefit. The Jing Si Herbal Tea Liquid Packet composed of eight native Taiwanese
      herbs (wormwo od, hickory grass, Ophiopogon japonicus, houttuynia cordata,
      platycodon,licorice, perilla leaves, chrysanthemum) has obtained a special export license
      from the Ministry of Health and Welfare. The Jing Si Herbal Tea Liquid Packet also has been
      registered i n clinical trials as a complementary treatment for Coronavirus disease
      2019(COVID-19). The preliminary data demonstrated that the Jing Si Herbal Tea Liquid Packet
      may improve gastrointestinal symptoms and anxiety in patients with COVID-19. Therefore,this
      study aims to investigate the impact of the Jing Si Herbal Tea Liquid Packet on
      psychophysical burden and metabolites of microbiota in patients with FD through a double
      blind randomized manner.
    


Intervention name(s): Jing Si Herbal Tea Liquid Packet; Jing Si Herbal Tea Liquid Packet Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): The preliminary data demonstrated that the Jing Si Herbal Tea Liquid Packet may improve gastrointestinal symptoms and anxiety in patients with Coronavirus disease 2019(COVID-19). Therefore,this study aims to investigate the impact of the Jing Si Herbal Tea Liquid Packet on psychophysical burden and metabolites of microbiota in patients with FD through a double-blind randomized manner.; Compared with the improvement effect of Jing Si Herbal Tea Liquid Packet, to avoid participants thinking that the improvement is due to psychological effects.
Other intervention name(s): Placebo
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: functional dyspepsia; Jing Si Herbal Tea Liquid Packet; psychophysical burden; Gut-brain axis dysregulation
Effects of Mulligan and Cyriax Approach in Patients With Subacute Lateral Epicondylitis.
Condition: Lateral Epicondylitis
MeSH terms: Tennis Elbow
Study type: Interventional

Summary: 
      Lateral epicondylitis (LE) is a pain causing musculoskeletal disease which mainly occurs due
      to the over exertion or over use of extensors of wrist mainly ECRB and pain is felt at the
      origin of common extensor tendon. This study was focused to assess the effectiveness of
      cyriax approach and mulligan approach to improve the functional status of sub acute lateral
      epicondylitis patients through patient related tennis elbow evaluation form.
    

Detailed description: 
      A total of 39 athletes with knee pain were recruited and randomly divided into two groups. 30
      subjects fulfilled the inclusion criteria and were part of this trial, 15 in each group.The
      data was collected through general demographic questionnaire, PRTEE questionnaire to
      determine the level of pain and functional disability and Hand grip strength chart to measure
      grip strength while having epicondylitis.
    

Intervention name(s): Cyriax approach i.e. DTF massage and Mill's manipulation; Mulligan approach i.e. Taping and MWM
Intervention type(s): Other; Other
Intervention description(s): Each patient in group I i.e. Cyriax group was given 20-minute session. Each session started in sitting position and initially deep transverse friction massage was done at lateral compartment of the elbow joint and immediately after that mill's manipulation at elbow joint with flexion at wrist joint in pronated arm position. This session was repeated three times a week for one month (Total 12 sessions/ one month).; Each patient in group II i.e. Mulligan group was given 30 to 45-minute session. Each session started in sitting position and it included mobilization with movement which was given in such a way that initially lateral glide at elbow joint was performed and after holding it, I asked the patient to make a fist and open the fist. In this way, I repeated this procedure 36 times and after 12 repetitions, a short rest period was given. Taping was applied after mobilization around the elbow joint over extensor carpi radialis muscles. This session was repeated three times a week for one month (Total 12 sessions/ one month).
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients were randomly assigned into two groups: Cyriax Approach group and Mulligan approach group. A coin was flipped at start of data collection for the first patient to be assigned odd number and included in cyriax group. Later on odd and even numbered patients were included in specific group. Additionally, data was collected from lateral epicondylitis patients visiting the DHQ Hospital Bahawalnagar.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Patient Rated Tennis Elbow Evaluation (PRTEE); Mobilization with movement; Deep Transverse friction massage
Study for Safety and Tolerability of TOP1288 Administered Orally in Healthy Subjects
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative
Study type: Interventional
Phase: Phase 1

Summary: 
      This study evaluates the safety and tolerability of TOP1288 oral single ascending and
      multiple doses in healthy subjects.
    


Intervention name(s): TOP1288; Placebo to TOP1288
Intervention type(s): Drug; Drug
Intervention description(s): Oral TOP1288; Oral placebo to TOP1288
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 3 dose groups (2 arms per dose group)
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Pharmacokinetics (PK) and Safety Evaluation of Daptomycin in Children Ages 3-24 Months With Proven or Suspected Gram-positive Infections or Peri-Operative Subjects Receiving Prophylactic Antibiotics
Condition: Gram Positive Bacterial Infection
MeSH terms: Infections; Communicable Diseases; Bacterial Infections; Gram-Positive Bacterial Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a research study designed to look at the pharmacokinetics (distribution, breakdown,
      and removal) and tolerability of a single dose of daptomycin in patients aged 3 months to 24
      months who have proven or suspected infections that are caused by a specific group of
      bacteria (called Gram-positive bacteria)or perioperative subjects that are receiving
      prophylactic antibiotics .
    


Intervention name(s): Daptomycin
Intervention type(s): Drug
Intervention description(s): Group 1: Ages 13 months to 24 months inclusive. Six subjects dosed at 6 mg/kg as a 30 minute infusion;
Group 2:Ages 7 months to 12 months inclusive: Six subjects will receive a dose of 4 mg/kg as a 30 minute infusion;
Group 3: Ages 3 months to 6 months inclusive: Six subjects will receive a dose of 4 mg/kg as a 30 minute infusion.
Other intervention name(s): Cubicin
Intervention MeSH terms: Daptomycin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Gram Positive Infection; Concurrent Antibiotic Treatment
Pharmacokinetics of CHF 5993 pMDI With and Without Spacer in COPD Patients
Condition: COPD
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is performed to investigate the effect of the spacing device on the
      pharmacokinetics of CHF 5993 pMDI active ingredients administered with and without
      Aerochamber Plus Flow-vu antistatic VHC spacer as a single administration in COPD patients.
      Moreover, the general safety and tolerability of the treatments will be evaluated.
    


Intervention name(s): Beclometasone/formoterol/glycopyrrolate; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): CHF5993 pMDI
Intervention MeSH terms: Beclomethasone; Glycopyrrolate; Formoterol Fumarate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety Follow-up of Treatment With Remestemcel-L in Pediatric Participants Who Have Failed to Respond to Steroid Treatment for Acute GVHD
Condition: Grade B Acute Graft Versus Host Disease; Grade C Acute Graft Versus Host Disease; Grade D Acute Graft Versus Host Disease
MeSH terms: Graft vs Host Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      Ongoing safety assessment follow-up to Protocol MSB-GVHD001 (NCT02336230) of remestemcel-L
      treatment in pediatric participants with acute graft versus host disease (aGVHD), following
      allogeneic hematopoietic stem cell transplant (HSCT), that have failed to respond to
      treatment with systemic corticosteroid therapy.
    

Detailed description: 
      This is a safety follow-up study through 180 days of remestemcel-L treatment in participants
      who took part in MSB-GVHD001. This study will also explore duration of response over time.
      Participants who took part in in MSB-GVHD001 and received at least one dose of remestemcel-L
      as outlined in that protocol will be evaluated at baseline (Day 100) and at Days 120, 140,
      160 and 180 for safety endpoints. Participants who took part in Protocol MSB-GVHD001 and
      received the first 8 doses of remestemcel-L as outlined in that protocol will be evaluated at
      baseline (Day 100) and at Days 120, 140, 160 and 180 after initial remestemcel-L infusion for
      evidence of duration of response over time.
    

Intervention name(s): Remestemcel-L
Intervention type(s): Biological
Intervention description(s): No intervention was given in Study MSB-GVHD002 (NCT02652130). It was a safety follow-up trial of remestemcel-L-treated participants from Study MSB-GVHD001.
Intervention MeSH terms: Remestemcel-l
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: GVHD
Evaluating the Pharmacokinetics, Safety, and Tolerability of Doravirine (MK-1439) and Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (MK-1439A) in HIV-1-Infected Children and Adolescents
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study was to evaluate the pharmacokinetics, safety, and tolerability of
      doravirine (also called MK-1439 or DOR) and doravirine/lamivudine/tenofovir disoproxil
      fumarate (also called MK-1439A or DOR/3TC/TDF) in HIV-1-infected children and adolescents.
    

Detailed description: 
      This study evaluated the pharmacokinetics (PK), safety, and tolerability of DOR and
      DOR/3TC/TDF in HIV-1-infected children and adolescents.

      This study was conducted in two cohorts: Cohort 1 and Cohort 2. At study entry (Day 0),
      participants in Cohort 1 received a single dose of DOR added to their current HIV regimens.
      (The antiretroviral drugs in their current HIV regimens were not be provided by the study.)
      Participants in Cohort 1 underwent intensive PK evaluations, and had an additional study
      visit at Week 2.

      The study team in consultation with a Study Monitoring Committee evaluated data from Cohort 1
      before enrolling participants in Cohort 2. Participants in Cohort 2 received DOR/3TC/TDF once
      daily from Day 0 through Week 96. They had study visits at Weeks 1, 2, 4, 8, 12, 16, 24, 36,
      48, 64, 80, and 96. Study visits included physical examinations, PK evaluations, and blood
      and urine collection.
    

Intervention name(s): Doravirine (DOR); Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF); Antiretroviral (ARV) medications
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 100 mg of DOR administered orally; DOR/3TC/TDF administered orally as a fixed-dose combination (as a tablet, 100 mg/300 mg/300 mg) once daily; Participants in Cohort 1 received a combination of dolutegravir (DTG) or raltegravir (RAL) plus two nucleoside reverse transcriptase inhibitors (NRTIs). The ARV drugs were prescribed by participants' own health care providers and were not provided by the study.
Other intervention name(s): MK-1439; MK-1439A; ARVs
Intervention MeSH terms: Tenofovir; Lamivudine; Anti-Retroviral Agents
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparison of Stapler Line Bleeding Control Techniquessurgery
Condition: Obesity, Morbid
MeSH terms: Obesity, Morbid
Study type: Interventional

Summary: 
      Introduction RYGB surgeon; Have become increasingly morbid obesity treatment methods with
      improvements in minimally invasive surgery. Ensuring patient comfort and early return to life
      are the criteria that should be given priority in this treatment method.The purpose of this
      study; Emphasizing that the cautery technique of the stapler line bleeding control methods is
      as successful as the other methods.
    

Detailed description: 
      The question of the availability of cautery in RYGB surgeons
    

Intervention name(s): Coutery
Intervention type(s): Other
Intervention description(s): Stapler line bleeding control with coutery
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Could Pre-operative Rectal Misoprostol Reduce Intra-operative Blood Loss During Ceserean Section?
Condition: Postpartum Haemorrhage
MeSH terms: Postpartum Hemorrhage; Hemorrhage
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      -  Misoprostol reduces the uterine bleeding after cesarean delivery without harmful effects
           on either mother or baby.

        -  The aim of the this study is to address if there is any benefits 'regarding the
           intra-operative blood loss' from preoperative rectal administration of 400 mic of
           Misoprostol in addition to the routinely administrated 10 units of oxytocin
    

Detailed description: 
      Research question:

      In women undergoing elective ceserean section, is preoperative 400 mic Misoprostol reduce
      intra-operative blood loss?

      Research hypothesis:

      pre-operative Misoprostol doesn't reduce intraoperative blood loss in women undergoing
      ceserean section
    

Intervention name(s): misoprostol; placeboo
Intervention type(s): Drug; Drug
Intervention description(s): 400 microgram of misoprostol is given preoperatively in patients undergoing elective cesarean section; women will recive 2 identical tablets as placeboo
Other intervention name(s): mesotac; control
Intervention MeSH terms: Misoprostol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Bell's Palsy With a Duration of Greater Than 8 Weeks Treated With Multiwave Locked System Intervention
Condition: Laser Treatment Relieve Symptoms of Chronic Bell's Palsy
MeSH terms: Bell Palsy; Facial Paralysis
Study type: Interventional

Summary: 
      OBJECTIVE: To determine whether photobiomodulation therapy by class IV Multiwave Locked
      System laser treatment could relieve symptoms in patients with Bell's palsy with a duration
      of greater than 8 weeks.

      METHODS AND METHODS: This randomized controlled trial from May 2021 to April 2023. Patients
      were eligible who had Bell's palsy with a duration of greater than 8 weeks on out-patient
      department of otorhinolaryngology in Beijing Tongren Hospital. The photobiomodulation group
      received class IV Multiwave Locked System laser treatment for 3 times per weeks, a total of 6
      months. The control group received the same Multiwave Locked System treatment procedure
      except the laser parameter. The primary outcome measures comprised House-Brackmann facial
      nerve grading system, Sunnybrook facial grading system, Facial Clinimetric Evaluation Scale.
      Secondary outcome measures comprised Electroneurography, Electromyography, and the Blink
      Reflex.
    


Intervention name(s): Multiwave Locked System
Intervention type(s): Device
Intervention description(s): Multiwave Locked System laser is a class IV NIR laser with two synchronized sources (905 nm with 75 W peak power, pulsed mode; 808 nm with power 1 W, continuous mode). Both laser beams were synchronized, the locked waves work with the range 1-2000 Hz.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Bell'palsy; photobiomodulation; RCT; ENoG; EMG
Single-site, Open-label, Randomized, Cross-over Study in Healthy Chinese Subjects to Evaluate the Bioequivalence of Single-dose Rotigotine Transdermal Patch Comparing 2 Different Formulations
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the study is to establish Bioequivalence (BE) of 2 different
      formulations of the 2 mg/24 hr (10 cm^2) Rotigotine transdermal patches in Chinese subjects.
    

Detailed description: 
      Bioequivalence will be concluded if the 90 % Confidence Intervals (CIs) for the ratio
      Treatment A/Treatment B are fully included in the acceptance range from 0.8-1.25 for AUC(0-t)
      and AUC, and within the acceptance range from 0.7 to 1.43 for Cmax.
    

Intervention name(s): Rotigotine PR2.2.1; Rotigotine PR2.1.1
Intervention type(s): Drug; Drug
Intervention description(s): Treatment A:
Rotigotine Transdermal patch 2 mg/24 hr (10 cm^2) Test drug product PR2.2.1. Single application of 1 patch for 24 hours.; Treatment B:
Rotigotine Transdermal patch 2 mg/24 hr (10 cm^2) Reference drug product PR2.1.1. Single application of 1 patch for 24 hours.
Intervention MeSH terms: Rotigotine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Rotigotine; Transdermal Patch; Bioequivalence
Safety and Efficacy Study of Oral Glycopyrrolate Liquid for the Treatment of Pathologic (Chronic Moderate to Severe) Drooling in Pediatric Patients 3 to 18 Years of Age With Cerebral Palsy or Other Neurologic Conditions
Condition: Cerebral Palsy; Neurological Conditions; Mental Retardation; Sialorrhea
MeSH terms: Sialorrhea; Paralysis; Cerebral Palsy; Intellectual Disability; Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      This is an open-label clinical research study of an oral glycopyrrolate liquid for the
      treatment of chronic moderate to severe drooling in patients with cerebral palsy or other
      neurological conditions. Patients participating in the study will receive oral glycopyrrolate
      liquid (1 mg/5 ml) three times a day (TID) for study duration of 24 weeks. After a washout,
      screening, and 2-day baseline period, patients will be enrolled in a 4-week dose titration
      period. Glycopyrrolate liquid doses will be titrated using dose levels in the Dose Titration
      Schedule. Titration will begin at 0.02 mg/kg per dose TID and sequentially increased in 0.02
      mg/kg per dose increments TID every 5-7 days during the first four weeks until optimal
      individualized response is obtained for each patient or a maximum dose of 0.1 mg/kg TID is
      reached, not exceeding 3 mg TID or Dose-level 5 in the Dose Titration Schedule, whichever is
      lesser. Optimal dose for each patient is the dose at which he/she is receiving the maximum
      benefit from the study drug (greatest improvement in drooling) while experiencing minimum
      side effects. All patients will receive close attention by study staff throughout the study.
    


Intervention name(s): Oral Glycopyrrolate Liquid
Intervention type(s): Drug
Intervention description(s): Study medication is administered three times a day at 7-8 AM, 1-2 PM, and 7-8 PM by the parent/caregiver
Intervention MeSH terms: Glycopyrrolate
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Mental Retardation; Neurological Impairment; Cerebral Palsy; Drooling; Neurological Conditions
Multiple Ascending Dose Study of TMP-301 in Healthy Subjects
Condition: Cocaine Use Disorder; Substance Use Disorders; Healthy Volunteers
MeSH terms: Substance-Related Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      A PHASE 1, RANDOMIZED, PLACEBO CONTROLLED, MULTIPLE ASCENDING DOSE (MAD) STUDY TO EVALUATE
      THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF TMP-301 IN HEALTHY SUBJECTS.
    

Detailed description: 
      This study will be a randomized, double-blind, placebo controlled, fixed sequence, MAD study.
      The study will be conducted in a single clinical research unit (CRU). The study will consist
      of up to 4 cohorts. Subjects will only participate in 1 cohort.

      Screening will occur within approximately 28 days prior to the first scheduled study drug
      administration. Subjects who meet all inclusion criteria and none of the exclusion criteria
      and who consent to participation will be admitted to the CRU for baseline evaluations prior
      to dosing.

      Subjects will be fasted overnight for 10 hours prior to the morning dose, followed by a 2
      hour fast. Subjects are fasted for 2 hours prior to dosing and 2 hours following the evening
      dose for the cohort 1 (50 mg bid).

      Subjects will be discharged from the CRU on Day 18. Subjects will return to the CRU on Day 25
      for a follow-up visit and EOS procedures.

      Caffeine (100 mg) will be included as probe CYP1A2 substrate in cohort 2 and subsequent
      cohorts.

      The maximum duration of subject participation, including Screening, will be approximately 53
      days.

      Subjects who terminate the study early will perform follow-up procedures at the time of Early
      Termination.
    

Intervention name(s): TMP-301; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Multiple ascending dose active; Multiple ascending dose comparator
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: sequential assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: drug addiction; cocaine use disorder; cocaine dependance; TMP-301; cocaine use; CUD; drug abuse