bioihbjkbjnl/mcl2 huggingface dataset:
Role of Probe-based Confocal Laser Endomicroscopy Targeted Biopsy in the Molecular Study of Undifferentiated Gastric Cancer
Condition: Undifferentiated Gastric Cancer
MeSH terms: Stomach Neoplasms
Study type: Interventional

Summary: 
      The purpose of this study is to conduct a study on genetic pathology, obtaining of pure
      cancer tissues is mandatory. Although the endoscopy with biopsy has been a gold standard for
      diagnosing gastric cancer, percentage of cancer cells in biopsy samples is usually 30% or
      less. Recently, confocal laser endomicroscopy has been introduced for real-time
      histopathologic diagnosis in various cancers. In previous pilot study in our institution,
      pCLE-targeted biopsy provided superior results in terms of the proportion of cancer cells in
      biopsy samples compared to WLE-targeted biopsy, especially for gastric cancers with
      undifferentiated histology. However, there was a limitation because of small sample size.
      Therefore, the investigators aim to evaluate that biopsy using probe-based confocal laser
      endomicroscopy for undifferentiated gastric cancer will increase the percentage of cancer
      cells and expression ratio of tumor marker in biopsy samples.
    


Intervention name(s): GastroFlex UHD, Cellvizio; Mauna Kea Technologies, Paris, France; white light endoscopy (WLE)
Intervention type(s): Device; Device
Intervention description(s): The patients who enrolled the pCLE group will undergo endoscopic biopsy using pCLE. The cancerous lesion is observed using probe-based confocal laser endomicroscopy. The biopsy was done at the most suspicious parts of the cancerous lesion.; The patients who enrolled this group will undergo endoscopic biopsy under standard white light endoscopy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: confocal laser endomicroscopy; undifferentiated gastric cancer; target biopsy
Sex Differences in Neuropeptide Y Serum, But Not in Fat Intake and Body Mass Index
Condition: Nutrient Deficiency
Study type: Interventional

Summary: 
      One's appetite has a role in controlling food intake and maintaining energy balance, but its
      effect on body metabolism related to obesity is still questionable. The purpose of this study
      was to determine the levels of neuropeptide Y in healthy people and to see differences in
      gender and anthropometric parameters. The hypothesis of this study was that there would be
      differences in neuropeptide Y levels in groups with gender and anthropometric parameter
      differences.
    

Detailed description: 
      One's appetite has a role in controlling food intake and maintaining energy balance, but its
      effect on body metabolism related to obesity is still questionable. The purpose of this study
      was to determine the levels of neuropeptide Y in healthy people and to see differences in
      gender and anthropometric parameters. The hypothesis of this study was that there would be
      differences in neuropeptide Y levels in groups with gender and anthropometric parameter
      differences. This study was a cross-sectional study involving 62 study subjects, male and
      female, who did not have chronic diseases or metabolic disorders. This research was conducted
      from April to September 2020. The parameters examined in this study were neuropeptide Y
      levels and anthropometric parameters. The statistical analysis performed was the Mann-Whitney
      test to see the differences between groups. The mean age of the research subjects was 40.48 ±
      10.85 years, with the same ethnic distribution. The distribution of men and women was more
      women than men. Based on anthropometric examination, it was found that obesity nutritional
      status was more common in the female group than in the male group; however, serum
      neuropeptide Y levels were found to be significantly different between male and female groups
      (male group was higher).
    

Intervention name(s): Neuropeptide Y examination
Intervention type(s): Diagnostic Test
Intervention description(s): This examination was conducted by drawing blood serum from research subjects and performing centrifugation with 2000-3000 revolutions per minute (RPM) for 20 minutes. Furthermore, we carried out blood serum tests to check neuropeptide Y levels using the Human Neuropeptide Y Enzyme-link Immunosorbent Assay (ELISA) kit
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
Keywords: obesity; appetite; neuropeptide; orexigenic; energy; gender
AMG0103 in Subjects With Chronic Discogenic Lumbar Back Pain
Condition: Degenerative Disc Disease
MeSH terms: Intervertebral Disc Degeneration; Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      This clinical trial evaluate the safety, tolerability and exploratory efficacy of targeted
      single injection of AMG0103 in subject with chronic discogenic lumbar back pain
    

Detailed description: 
      This is a Phase 1b, multicenter, double-blind, single ascending dose study designed to
      evaluate the safety of AMG0103 in adult male and female subjects with chronic discogenic
      lumbar back pain.

      This protocol anticipates that 8 subjects with symptomatic single level discogenic pain will
      be enrolled in each of up to 3 dose-escalation cohorts. Subjects in each cohort will receive
      AMG0103 or Placebo as a targeted, single, intradiscal injection.
    

Intervention name(s): Placebo; AMG0103
Intervention type(s): Drug; Drug
Intervention description(s): single intradiscal injection; single intradiscal injection
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: disc degeneration; Intervertebral disc; discogenic pain; chronic discogenic lumbar back pain
Postoperative Analgesia After Laparoscopic Living Donor Nephrectomy
Condition: Living Donors
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of the study is to investigate if perioperative administration of pregabalin vil
      reduce postoperative pain and the postoperative need for intravenous opioids compared with
      todays standard treatment which consist of paracetamol, corticoids and ketobemidone.

      In addition potential sideeffects as sedation and effect on cognitive function will be
      recorded.
    


Intervention name(s): Pregabalin; Sugar pill
Intervention type(s): Drug; Drug
Intervention description(s): 150 mg x 2 daily for 2 days; 1 tablet x 2 daily, for 2 days
Other intervention name(s): Lyrica ATC-nr.: NO3A X 160
Intervention MeSH terms: Pregabalin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Kidney
Preoperative Warm-up in Gynecologic Surgery
Condition: Gynecologic Disorders
MeSH terms: Genital Diseases, Female
Study type: Interventional
Phase: Phase 1

Summary: 
      Background and Objectives: All modern surgical procedures require a high level of cognitive
      and psychomotor skills achieved using different training methods, but could be influenced by
      fatigue and other psychological factors. We evaluate the effect of warm-up exercises on
      operative laparoscopic performances in gynecologic laparoscopic procedures.

      Methods: The surgical team operates on a consecutive series of 20 patients and perform
      laparoscopic salpingo-oophorectomy. Patients are randomly allocated in 2 groups: group A to
      be operated on without warm-up exercises and group B to be operated on after a short-term
      warm-up. All patients are operated on by the same surgical team. The full-time records of the
      operation were analyzed by 2 independent reviewers. Laparoscopic procedures are recorded and
      assessed by 2 independent observers using the generic OSATS rating scale. A training module
      using the Lap Sim simulator was designed for the warm-up.
    


Intervention name(s): Preoperative Warm-Up training
Intervention type(s): Other
Intervention description(s): Preoperative Warm-Up training
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: laparoscopy; surgery; warm-up; preoperative; surgical skills
A Drug Drug Interaction (DDI) Study of Pirtobrutinib (LY3527727) and Rosuvastatin in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to determine the effect of pirtobrutinib on the levels of
      rosuvastatin in the blood stream in healthy participants. This study will also evaluate the
      safety and tolerability of rosuvastatin when administered in combination with pirtobrutinib
      in healthy participants. This study will last up to approximately 26 days excluding screening
      period.
    


Intervention name(s): Rosuvastatin; Pirtobrutinib
Intervention type(s): Drug; Drug
Intervention description(s): Administered Orally.; Administered Orally.
Other intervention name(s): LY3527727
Intervention MeSH terms: Rosuvastatin Calcium; Pirtobrutinib
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Dry Needling in Post-operative Shoulder Pain
Condition: Proximal Humeral Fracture Fixated With PHILOS© Plate; Rotator Cuff Tear Surgical Repair
MeSH terms: Shoulder Pain; Rotator Cuff Injuries; Humeral Fractures; Shoulder Fractures
Study type: Interventional

Summary: 
      Fractures of the proximal humerus account for between 5% and 8% off all reported fractures.
      Post-operative shoulder pain is highly frequent. Due to either surgical procedure, soft
      tissues surrounding the shoulder area can be damaged. The purpose of the current clinical
      trial was to compare the effects of physiotherapy versus physiotherapy plus TrP-DN on pain
      and function in patients who exhibit post-operative shoulder pain after a PHILOS procedure
      for proximal humeral fixation or rotator cuff tear repair.
    


Intervention name(s): Physical therapy plus dry needling; Physical therapy
Intervention type(s): Other; Other
Intervention description(s): Best-evidence physical therapy intervention in addition to a single session of TrP-DN targeted to active TrPs in the neck-shoulder muscles; Best-evidence physical therapy intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Improved Skin Anti-aging Outcomes Associated With Collagen Fortified Consumption In 30 to 50-Year-old Women
Condition: Skin Laxity; Skin Lines
MeSH terms: Cutis Laxa
Study type: Interventional

Summary: 
      The goal of this clinical trial is to study the efficacy of collagen supplement on the
      moisture content and elasticity.

      70 participants of 30-50 years old women will be enrolled from two study sites and randomly
      assigned to use two products (study product plus collagen supplement and placebo product
      without collagen supplement) for 2 months.

      Researchers will compare the two groups to validate the assumption that there is significant
      improvement on skin anti-aging effect for participants using study product plus collagen
      supplement.
    

Detailed description: 
      This study is two arms, randomized, double-blind controlled trial. There will be two study
      sites and 35 eligible participants at each study site will be enrolled with the expectation
      of having 30 participants completed per study group. Particants will be randomly allocated to
      use one of the two study products defined in the trial protocol for two months. Up to three
      study visits will be made by the participant over a 2-month period. All relevant data will be
      captured and recorded into CTMS (Clinical Trial Management System). The data will be analyzed
      and reported after the completion of the study.
    

Intervention name(s): Study product plus collagen supplement; Study product without collagen supplement
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): The participants in this arm will use the assigned product for 2 months, 5g one time, once a day.; The participants in this arm will use the assigned product for 2 months, 5g one time, once a day.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: Collagen; skin anti-aging; skin moisture; skin elasticity
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of NBI-74788 in Pediatric Subjects With Congenital Adrenal Hyperplasia
Condition: CAH - Congenital Adrenal Hyperplasia
MeSH terms: Adrenal Hyperplasia, Congenital; Adrenogenital Syndrome; Adrenocortical Hyperfunction; Hyperplasia
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase 2, open-label, multiple-dose, dose-escalation study to assess the safety,
      tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of NBI-74788 in approximately
      12 pediatric female and male subjects (14 to 17 years of age) with a documented medical
      diagnosis of classic 21-hydroxylase deficiency congenital adrenal hyperplasia (CAH).
    


Intervention name(s): NBI-74788
Intervention type(s): Drug
Intervention description(s): NBI-74788 administered orally for 14 consecutive days.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Long-term Safety and Efficacy of ABP 501 in Subjects With Moderate to Severe Rheumatoid Arthritis
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this open-label study is to evaluate the long-term safety and efficacy of ABP
      501 in adults with moderate to severe rheumatoid arthritis (RA).
    


Intervention name(s): ABP 501
Intervention type(s): Biological
Intervention description(s): Solution for subcutaneous injection in a syringe containing 40 mg/0.8 mL ABP 501
Other intervention name(s): AMJEVITA™; Adalimumab-atto
Intervention MeSH terms: Adalimumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: arthritis; rheumatoid
A Study to Evaluate the Effect of Omeprazole on the Pharmacokinetics of BMS-986205 in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the effect of multiple dose administrations of
      Omeprazole on the pharmacokinetics of BMS-986205.
    


Intervention name(s): BMS-986205; omeprazole
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive BMS-986205 on Days 1 and 15; Participants will receive omeprazole on Days 10 to 15
Intervention MeSH terms: Omeprazole; Linrodostat
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Randomized Trial of Regenexx Stem Cell Support Formula
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      Regenexx, LLC developed a nutritional supplement formula containing many components related
      to supporting healthy joints This oral, liquid supplement is intended to help improve joint
      and cartilage health while also increasing their joint function. The goal of this study is to
      measure changes in joint health and function for patients with knee OA taking this supplement
      for 2 months.
    

Detailed description: 
      The study design is a double-blind, randomized, placebo-controlled multicenter study. Liquid
      Regenexx Stem Cell Support Formula compared to placebo control administered via oral
      application for 2 months to determine effect on knee function and pain in patients with knee
      OA.

      Treatment group: Forty patients randomized to the treatment group will receive daily doses of
      stem cell support formula for 60 days. Patients will complete patient-reported outcome
      questionnaires at 1 month and 2 months.

      Control group: Forty patients randomized to the control group will receive a daily doses of
      placebo stem cell support formula for 60 days. Patients will complete patient-reported
      outcome questionnaires at 1 month and 2 months.
    

Intervention name(s): Stem Cell Support Formula; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): This liquid supplement contains the following ingredients: chondroitin sulfate, glucosamine sulfate, vitamin C (ascorbic acid), curcumin and Bioperine®, resveratrol, L-carnosine, bitter melon, and vitamin D.; The placebo comparator will look and taste similar without the active ingredients of the Stem Cell Support Formula.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Supportive Care
Safety and Efficacy of AAE581 in Postmenopausal Women With Osteoporosis
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will test the safety and efficacy of AAE581 in increasing Lumbar Spine bone
      mineral density (BMD) at 12 months, by Dexa-scan (DXA) in postmenopausal women with
      osteoporosis.
    


Intervention name(s): AAE581
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: osteoporosis/osteopenia, BMD, postmenopausal
A Pilot Study of Pre-Exposure Prophylaxis (PrEP) to Evaluate Safety, Acceptability, and Adherence in At-risk Populations in Uganda, Africa
Condition: HIV Infection
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study will evaluate the safety and acceptability of intermittent and daily pre-exposure
      prophylaxis (PrEP) regimens with FTC/TDF (emtricitabine/tenofovir disoproxil fumarate) in HIV
      discordant couples, and it will directly compare adherence and intracellular drug levels in
      daily and intermittent PrEP recipients. It will also evaluate the relationship between drug
      adherence, sexual behavior and intracellular drug levels with an intermittent PrEP regimen.
      In addition it will evaluate the relationship between adherence to an intermittent PrEP
      regimen and timing of sexual activity in relation to PrEP dosing. The pilot will use
      objective medication event monitoring (MEMS) adherence measurement and evaluate the
      feasibility of newer adherence measurements such as hair sampling and plasma drug levels.
      This study will also evaluate the feasibility of using text messaging (SMS) to collect sexual
      activity data in an African setting. It will allow study teams and communities to prepare for
      potential subsequent larger trials of intermittent PrEP. The study is not sized to evaluate
      efficacy. If the intermittent PrEP regimen is safe, feasible in terms of adherence, and
      achieves intracellular drug levels similar to daily PrEP, the data could be used to design a
      larger phase 2 study with one or more intermittent PrEP regimens. The goal of such a larger
      trial would be to provide bridging data if daily PrEP regimens are found to be effective or
      to prepare for efficacy or non-inferiority trials of intermittent versus daily PrEP.

      Investigation of immune responses associated with FTC/TDF will also be evaluated in the pilot
      study. The proportion of volunteers on FTC/TDF with HIV-specific immune responses, due to
      exposures that did not lead to established HIV infection, will be assessed at 2-3 time points
      and compared to responses in volunteers assigned to placebo. Immune responses may be
      correlated with risk behavior and host factors, such as human leukocyte antigen (HLA) type.
      As noted above, very few HIV infections are expected to occur during the study, so
      correlation of HIV-specific immune responses and protection from infection or attenuation of
      disease progression will not be possible until a larger study is conducted.
    


Intervention name(s): FTC/TDF; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): emtricitabine/tenofovir disoproxil fumarate; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: HIV; Human Immunodeficiency Virus
Safety, Tolerability, and Pharmacokinetics of SAB-185 in Healthy Participants
Condition: COVID-19; SARS-CoV2
Study type: Interventional
Phase: Phase 1

Summary: 
      Coronavirus disease 2019 (COVID-19) is an infectious disease caused by severe acute
      respiratory syndrome coronavirus 2 (SARS-CoV-2). SAB Biotherapeutics has developed SAB-185,
      an Anti-SARS-CoV-2 Human Immunoglobulin Intravenous (transchromosomic [Tc] bovine-derived),
      as a potential therapeutic to treat COVID-19. This study will evaluate the safety,
      immunogenicity, and pharmacokinetics of SAB-185 in healthy participants.
    

Detailed description: 
      There were 4 treatment groups and 1 control group. Cohort 1 received 1 dose of SAB-185 at 10
      mg/kg per dose. Cohort 2 received 1 dose of SAB-185 at 25 mg/kg, Cohort 3 received 2 doses of
      SAB-185 at 25 mg/kg each 7 days apart, and Cohort 4 received 1 dose of SAB-185 at 50 mg/kg
      per dose. All the doses were prepared at the site by the pharmacy staff or designee for
      delivery to the clinical staff for administration, per the site's SOPs.
    

Intervention name(s): SAB-185; Normal saline
Intervention type(s): Biological; Other
Intervention description(s): SAB-185 is a purified human immunoglobulin G (hIgG) designed to specifically bind to Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) viruses. SAB-185 is purified from the plasma of immunized Tc bovines that were immunized initially (vaccinations 1 and 2) with a plasmid DNA (pDNA) vaccine that expresses wild-type SARS-CoV-2 spike protein, followed by additional immunizations (vaccinations 3 and beyond) with a recombinant spike protein from SARS-CoV-2 produced in insect cells. The purified hIgG is a sterile liquid formulated in 10 mM glutamic acid monosodium salt, 262 mM D-sorbitol, 0.05 mg/mL Tween 80, pH 5.5. The drug product will be administered intravenously and will be diluted in saline per the clinical protocol.; Normal (0.9%) saline in approximately the same volume as each cohort in the experimental drug arm.
Other intervention name(s): Anti-SARS-CoV-2 Human Immunoglobulin Intravenous (Tc bovine-derived)
Intervention MeSH terms: Immunoglobulins; Immunoglobulins, Intravenous
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment