bioihbjkbjnl/mcl2 huggingface dataset:
A Phase 2 Clinical Trial Examining the Effects on Osteoarthritic Knee Pain of CGS-200-1, CGS-200-5 and Vehicle Control
Condition: Osteoarthritis, Knee; Pain
MeSH terms: Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a multi-center, randomized, double-blind clinical trial to examine the comparative
      effects on OAKP of CGS-200-1 (1% Capsaicin content) (N=40), CGS-200-5 (5% Capsaicin content)
      (N=40), and CGS-200 Vehicle (no Capsaicin) (N=40) in subjects with OA of the knees according
      to the 1986 American College of Rheumatology (ACR) criteria. Assigned doses will be applied
      at the clinic for 60 minutes on each of four consecutive days.
    

Detailed description: 
      Subjects will be randomized to one of the three Arms in this study: CGS-200-1 or CGS-200-5 or
      CGS-200 Vehicle (CGS-200-0). All subjects will receive 4 consecutive days of treatment and
      will then be followed up until the Day 94 visit.

      Even though both knee(s) will receive application of study test materials, with regard to
      reduction in WOMAC pain and VAS pain score associated with study treatments, only one knee
      will be indicated as the "Study Knee". This will be the knee with the highest WOMAC pain
      score at screening. If both knees have equal WOMAC pain scores at baseline, then the right
      knee will be considered the "Study Knee" with regard to WOMAC pain and VAS pain score
      reduction.

      Data will be collected from Day 1 through Day 5 and then again on Days 19, 35, 64 and 94 for
      efficacy, tolerability, and safety measures. The Investigators, all site staff and Clinical
      Research Organization (CRO) personnel (except the Medical Monitor providing safety oversight)
      directly involved in the study will remain blinded to the treatment assignment throughout the
      trial.
    

Intervention name(s): CGS-200-1; CGS-200-5; CGS-200 Vehicle
Intervention type(s): Drug; Drug; Drug
Intervention description(s): CGS-200-1 is a multi-component formulation in which the active ingredient for the intended therapeutic effect is capsaicin at a level of 1% for this study.; CGS-200-5 is a multi-component formulation in which the active ingredient for the intended therapeutic effect is capsaicin at a level of 5% for this study.; CGS-200 Vehicle contains all of the ingredients in CGS-200-1 and CGS-200-5 except for capsaicin.
Other intervention name(s): CGS-200 (1% capsaicin); CGS-200 (5% capsaicin); CGS-200 (0% capsaicin)
Intervention MeSH terms: Capsaicin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effects of Eplerenone on Cardiovascular Disease in HIV (MIRACLE HIV Study)
Condition: HIV
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      HIV-infected individuals treated with antiretroviral medications are living longer, but have
      an increased risk of heart disease when compared to non-HIV-infected individuals. A hormone
      called aldosterone, which regulates blood pressure and sodium balance, is elevated in the HIV
      population in association with with increased belly fat and altered glucose metabolism.
      Elevations in aldosterone hormone may also be associated with abnormal blood flow,
      inflammation, and coronary plaque in the heart. This study is being conducted to evaluate
      whether therapies to reduce the actions of aldosterone may decrease the burden and
      progression of heart disease in the HIV population.
    

Detailed description: 
      This is a 12 month randomized, placebo controlled study enrolling HIV-infected individuals
      with no known history of cardiovascular disease. Eplerenone is a mineralocorticoid receptor
      antagonist, which can block aldosterone activation. This medication is approved by the FDA
      for high blood pressure and heart failure. This study aims to investigate the effect of
      eplerenone on other measures of cardiovascular disease in HIV. Using PET, MRI, and CT imaging
      technology, this study will evaluate whether eplerenone can improve coronary flow reserve and
      myocardial inflammation/fibrosis, in addition to atherosclerotic plaque build-up among the
      HIV population. The study also includes teaching on lifestyle modification to promote a
      healthy diet and exercise program.There are 3 overnight visits in addition to safety visits.
    

Intervention name(s): Eplerenone; Placebo; Lifestyle Modification
Intervention type(s): Drug; Drug; Behavioral
Intervention description(s): Eplerenone 50mg by mouth twice daily; Placebo by mouth twice daily; Counseling regarding diet and healthy activity
Intervention MeSH terms: Eplerenone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Eplerenone; Cardiovascular Disease; Mineralocorticoid Receptor Antagonist; Coronary Vasculature; Myocardial Inflammation; Myocardial Fibrosis; Atherosclerosis; Aldosterone
Aggressive Prostate Cancers in Elderly Patients
Condition: Prostatic Neoplasms
MeSH terms: Prostatic Neoplasms
Study type: Observational

Summary: 
      Patients aged 70 years or older had a higher possibility of high risk cancer than younger
      patients.
    

Detailed description: 
      Patients aged 70 years or older had a higher risk of advanced prostate cancer and shorter
      BCR-free survival than younger ones. Definite treatment of clinically localized prostate
      cancer should be actively considered in well-selected healthy patients older than 70 years.
    

Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Men who underwent radical prostatectomy for the treatment of clinically localized prostate
        cancer
      
Keywords: prostate-specific antigen; radical prostatectomy
Prevalence and Characteristics of Transthyretin Amyloidosis in Patients With Left Ventricular Hypertrophy of Unknown Etiology
Condition: Transthyretin Amyloidosis Cardiomyopathy (ATTR-CM)
MeSH terms: Amyloid Neuropathies, Familial; Cardiomyopathies; Hypertrophy, Left Ventricular; Amyloidosis; Hypertrophy
Study type: Observational

Summary: 
      The main purpose of this study is to determine the prevalence of ATTR Cardiomyopathy among
      patients admitted due to Left Ventricular Hypertrophy (LVH) >15mm of unknown etiology by
      using a 99mTc-tracer scintigraphy based protocol
    


Intervention name(s): Diagnosis of TTR amyloidosis cardiomyopathy
Intervention type(s): Diagnostic Test
Intervention description(s): Diagnosis of TTR amyloidosis cardiomyopathy with scintigraphy
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients with HCM from undiagnosed etiology
      
Keywords: Scintigraphy; Gammagraphy; TTR; ATTR; Hypertrophic cardiomyopathy (HCM); HCM
Comparing Intravenous and Oral Paracetamol for Cholecystectomy
Condition: Laparoscopic Cholecystectomy
Study type: Interventional
Phase: Phase 4

Summary: 
      To determine the amount of paracetamol in the blood when given in either intravenous or oral
      forms prior to cholecystectomy. The clinical effectiveness of each form will also be
      evaluated with pain scores and the use of other pain relief drugs.
    


Intervention name(s): Paracetamol (acetaminophen)
Intervention type(s): Drug
Intervention MeSH terms: Acetaminophen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: paracetamol; acetaminophen; pharmacokinetic; intravenous; oral; analgesia; pain; opioid
Study of a JAK3 Inhibitor for the Prevention of Acute Rejection in Kidney Transplant Patients
Condition: Kidney Transplantation
Study type: Interventional
Phase: Phase 2

Summary: 
      A new immunosuppressive drug, based on the inhibition of an important enzyme in the immune
      system called JAK3, is being developed by Pfizer to prevent transplant rejection. In this
      research study, a JAK3 inhibitor or cyclosporine will be given to new kidney transplant
      patients for 12 months. Patients will be assigned to one of three treatment groups after
      receiving a kidney transplant. Two of the treatment groups will receive 2 different dosing
      regimens of the JAK3 inhibitor that will be taken by mouth. The third treatment group will be
      a standard-of-care control arm. Patients will continue to take the assigned study medication
      for 12 months as well as other standard transplant medications such as prednisone.
    


Intervention name(s): Cyclosporine; CP-690,550; CP-690,550
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Standard of care; CP-690,550 15 mg BID for Months 1-6, then 10 mg BID for Months 7-12; CP-690,550 15 mg BID for Months 1-3, then 10 mg BID for Months 4-12
Intervention MeSH terms: Cyclosporine; Cyclosporins; Tofacitinib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Immunosuppression; JAK3 inhibitor; kidney transplantation.
Surgery With or Without Chemotherapy in Treating Patients With Stage II or Stage III Cancer of the Esophagus
Condition: Esophageal Cancer
MeSH terms: Esophageal Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. It is not known whether chemotherapy before surgery is more
      effective than surgery alone in treating cancer of the esophagus.

      PURPOSE: Randomized phase III trial to compare the effectiveness of surgery with or without
      chemotherapy in treating patients with stage II or stage III cancer of the esophagus.
    

Detailed description: 
      OBJECTIVES: I. Compare resectability and survival in patients with stage II/III esophageal
      cancer treated with neoadjuvant cisplatin/fluorouracil vs. surgery alone.

      OUTLINE: This is a randomized study. Patients are randomized to one of two groups. The first
      group receives cisplatin and fluorouracil every 4 weeks for 3 courses followed by
      esophagectomy and regional lymphadenectomy. The second group undergoes esophagectomy and
      regional lymphadenectomy alone. All patients are followed for survival.

      PROJECTED ACCRUAL: A total of 240 patients will be entered over 4 years.
    

Intervention name(s): cisplatin; fluorouracil; conventional surgery
Intervention type(s): Drug; Drug; Procedure
Intervention MeSH terms: Fluorouracil
Allocation: Randomized
Primary purpose: Treatment
Keywords: stage II esophageal cancer; stage III esophageal cancer; squamous cell carcinoma of the esophagus
Reducing Adverse Delivery Outcomes Through Teleneonatology: A Feasibility Study
Condition: Newborn Morbidity
Study type: Interventional

Summary: 
      Teleneonatology, the use of audio-video communication to facilitate neonatal-perinatal care,
      may bridge the resuscitation quality gap by connecting centers with lower level care to
      experienced care providers. Using randomized trial design, this investigation will compare
      teleneonatal resuscitation facilitated by a neonatologist to standard resuscitation within a
      simulated environment.
    

Detailed description: 
      Multiple studies have evaluated telemedicine using simulation, but the level of evidence for
      the use of telemedicine to improve neonatal resuscitation is low.

      In this investigation and within a simulated environment, pediatric interns and residents
      will resuscitate a simulated 25 week infant at delivery assisted by a simulated nurse and
      respiratory therapist. Participants will be randomized to resuscitation performed either with
      or without telemedicine facilitated by a neonatologist. The primary outcome will be time to
      effective ventilation with other secondary outcomes including metrics derived from the
      American Academy of Pediatrics Neonatal Resuscitation Program.
    

Intervention name(s): Resuscitation Personnel
Intervention type(s): Other
Intervention description(s): Type of resuscitation team
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: telemedicine; simulation; neonatal resuscitation
An Open Label Study to Examine the Effect of Coated Nifedipine Suppositories on Anal Pressure in Healthy Subjects
Condition: Anal Resting Pressure
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is an open label, dose-finding study. Approximately 8 healthy subjects will be
      participating in this study.

      Within one week after the screening visit, subjects who meet all inclusion criteria and none
      of the exclusion criteria will enter a one day treatment period. During this period, 4 anal
      manometric studies will take place. Study medication (Coated Nifedipine suppositories at
      various doses) will be administered at pre-determined intervals. During the study, blood
      samples will be obtained for plasma Nifedipine analysis.
    

Detailed description: 
      After detrminig baseline resting anal pressure with a manometric test, coated Suppositories
      will be administered intra rectally. Subjects will take rectally a total of 3 Coated
      Suppositories per study. 90 minutes after each coated suppository insertion this suppository
      will be removed and a amnometric study will be performed:

      The first dose will contain 4 mg of Nifedipine and the manomentric measurement performed
      afterwards will be used to determine baseline anal pressures.

      The second dose will contain 12 mg of Nifedipine. The third dose will contain 24 mg of
      Nifedipine. The primary efficacy parameter is change in Resting Anal Pressure from baseline.

      The secondary efficacy parameters include the following:

        -  The ratio of change in anal pressure to plasma Nifedipine level.

        -  The ratio of change in anal pressure to change in blood pressure.

        -  The ratio of change in anal pressure to change in heart rate.
    

Intervention name(s): Coated Nifedipine Suppositories
Intervention type(s): Drug
Intervention description(s): Subjects will take rectally a total of 3 Coated Suppositories per study. 90 minutes after each coated suppository insertion this suppository will be removed and a amnometric study will be performed:
The first dose will contain 4 mg of Nifedipine and the manomentric measurement performed afterwards will be used to determine baseline anal pressures.
The second dose will contain 12 mg of Nifedipine. The third dose will contain 24 mg of Nifedipine.
Intervention MeSH terms: Nifedipine
Intervention model: Single Group Assignment
Assessing the Impact of Opioid-Free Anesthesia Using the Modified Mulimix Technique.
Condition: Opioid Use
Study type: Observational

Summary: 
      The effective management of post-operative pain in the setting of bariatric surgery presents
      significant hurdles for both anesthesiologists and surgeons. The objective of this study was
      to assess the effects of opioid-free anesthesia (OFA) using the modified mulimix technique on
      the levels of plasma interleukin-2 (IL-2) and interleukin-6 (IL-6) as the primary outcome.
      Additionally, the study aimed to evaluate the duration of analgesia and the analgesic
      requirements within the first twenty-four hours after surgery.
    

Detailed description: 
      Objectives: The effective management of post-operative pain in the setting of bariatric
      surgery presents significant hurdles for both anesthesiologists and surgeons. The objective
      of this study was to assess the effects of opioid-free anesthesia (OFA) using the modified
      mulimix technique on the levels of plasma interleukin-2 (IL-2) and interleukin-6 (IL-6) as
      the primary outcome. Additionally, the study aimed to evaluate the duration of analgesia and
      the analgesic requirements within the first twenty-four hours after surgery.

      Methods: 60 patients were systematically selected and randomly assigned to Group A (OFA) and
      Group B (Opioid-Containing Anesthesia, OCA), with the modified Mulimix technique employed.
      Serum samples were collected from all patients, both at the onset of the skin incision and
      after the surgical procedure. These samples were then used to assess interleukin-2 (IL-2) and
      interleukin-6 (IL-6) levels. Additionally, the post-operative analgesic consumption was
      documented.
    

Intervention name(s): opioid-FREE anesthesia.; opioid-CONTAINING anesthesia.
Intervention type(s): Drug; Drug
Intervention description(s): They received opioid-free anesthesia. These patients were provided a multimodal combination infusion. The administration of this infusion commenced at a dosage of 0.2 micrograms per kilogram per hour of dexmedetomidine. The "Modified Mulimix" cocktail, consisting of dexmedetomidine at a concentration of 10 ug/ml, Ketamine at a concentration of 2.5 mg/ml, and Lignocaine at a concentration of 20 mg/ml, was administered to a patient weighing 100 kg and if the weight is 110 Kg the rate will be increased by 10 percent, etc.,; The process of inducing anesthesia included the injection of fentanyl at a dosage of 2 micrograms per kilogram during the induction phase. Additionally, morphine was administered at a dose of 0.03 milligrams per kilogram at the time of port insertion.
Other intervention name(s): GROUP (A); GROUP (B)
Intervention MeSH terms: Analgesics, Opioid; Anesthetics
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        A study was conducted on a sample of 60 patients, comprising individuals of both genders
        aged between 20 and 50 years.
Effect of Maxillary Third Molar Extraction vs. Non-extraction on Distalization of First Molars in a Group of Adolescent Patients
Condition: Class II Malocclusion
MeSH terms: Malocclusion; Malocclusion, Angle Class II; Overbite
Study type: Interventional

Summary: 
      There is a scarcity in literature regarding the influence of maxillary third molar on
      distalization . This study aimed to compare the influence of unerupted maxillary third molars
      and their extraction on the bilateral distalization of upper first molars using the
      infra-zygomatic gear distalizer
    

Detailed description: 
      Maxillary molar distalization is one of the non-extraction modalities for treating class II
      malocclusion. When distalizing maxillary molars In adults, it is not a problem to extract
      fully erupted third molars, and it may even be suggested that the extraction site may
      accommodate distalization. On the contrary, adolescents usually have unerupted third molars
      with partially formed roots, rendering the surgical extraction more difficult and traumatic.
      The necessity of surgically extracting upper third molar buds before distalization remains
      questionable. Therefore, this study was conducted to three-dimensionally assess the impact of
      maxillary third molar presence on distalizing maxillary molars in adolescent patients having
      Class II malocclusion.
    

Intervention name(s): Distalization combined with upper third molars extraction; Distalization without upper third molars extraction
Intervention type(s): Procedure; Procedure
Intervention description(s): After surgical extraction of unerupted upper third molars, the maxillary first molars were distalized using a labial bow with two soldered crimpable hooks distal to the upper lateral incisors. The labial bow fitted in the flying tube of the upper first molar bands. It was anchored bilaterally to the infra-zygomatic mini-implant by closed coil spring that applied a force of 300gm on each side; The maxillary first molars were distalized , without extracting upper third molars, using a labial bow with two soldered crimpable hooks distal to the upper lateral incisors. The labial bow fitted in the flying tube of the upper first molar bands. It was anchored bilaterally to the infra-zygomatic mini-implant by closed coil spring that applied a force of 300gm on each side
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Infra-zygomatic mini-implant; Distalization; Infra-zygomatic crest; Digital models; molar tipping
A Multiple Dose Study of LY3502970 in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to assess how fast LY3502970 gets into the blood stream and
      how long it takes the body to remove it when administered in multiple oral doses as new
      formulation compared to that of reference LY3502970 formulation. Information about safety and
      tolerability will be collected. The study is open to healthy participants. The study is
      conducted in two parts and it will last up to about 6 months, inclusive of screening period.
    


Intervention name(s): LY3502970; Esomeprazole
Intervention type(s): Drug; Drug
Intervention description(s): Administered orally.; Administered orally.
Intervention MeSH terms: Esomeprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Effect of Oral Rufinamide and Oxcarbazepine on Nerve Excitability, Hyperalgesia, Allodynia and Flare Reaction Compared to Placebo. A Monocenter, Randomized, Double-blind, Cross-over Study
Condition: Healthy Subjects
Study type: Observational

Summary: 
      Untersuchungen über die Wirkmechanismen von Antiepileptika haben gezeigt, dass durch eine
      Blockierung von spannungsabhängigen Natrium-Kanälen im Nervensystem die Schmerzübertragung
      moduliert werden kann. Verschiedene Antiepileptika werden in der chronischen Schmerztherapie
      schon lange angewendet (z.B. Oxcarbazepinum, Trileptal ® bei Trigeminusneuralgie oder
      diabetischer Polyneuropathie).

      In unserer Untersuchung wollen wir zwei in der Schweiz zugelassene Antiepileptika bezüglich
      ihrer Wirkung auf das Schmerzempfinden untersuchen. Eines dieser Medikamente, Trileptal®
      (Wirkstoff: Oxcarbazepinum), wird schon häufig bei chronischen Schmerzzuständen eingesetzt.
      Das zweite Medikament, Inovelon® (Wirkstoff: Rufinamid) ist seit mehr als einem Jahr in der
      Schweiz zugelassen und wird klinisch vor allem in der Behandlung von besonderen
      Epilepsieformen im Kindesalter eingesetzt. Wir erwarten, dass auch nach Gabe von Inovelon®
      die Schmerzleitung in den Nervenzellen verändert und die lokalen Schmerzreaktionen in der
      Haut vermindert werden.

        -  Trial with medicinal product
    


Intervention name(s): Rufinamid
Intervention type(s): Drug
Intervention description(s): Effect of oral rufinamide and oxcarbazepine on nerve excitability, hyperalgesia, allodynia and flare reaction compared to placebo.
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        healthy volunteers
      
Keywords: gesunde Probanden