bioihbjkbjnl/mcl2 huggingface dataset:
Pain Management After Adductor Canal Block for Total Knee Arthroplasty
Condition: Knee Osteoarthritis; Knee Arthritis; Knee Arthropathy; Knee Pain Chronic
MeSH terms: Osteoarthritis; Osteoarthritis, Knee; Joint Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      This randomized, double-blinded, placebo-controlled trial sought to evaluate the efficacy of
      the iPACK block with Adductor Canal Block on postoperative pain, functional recovery and NLR
      and PLR levels.
    

Detailed description: 
      The Interspace between the popliteal artery and capsule of the posterior knee, or iPACK
      block, together with the Adductor Canal block (ACB), has been described and shows promise in
      providing analgesia to the knee joint. However, the effect of these two blocks on
      postoperative pain levels, functional recovery, and stress response is uncertain. This study
      compares a preoperative iPACK and ACB block to Sham blocks before total knee arthroplasty
      under spinal anesthesia.
    

Intervention name(s): Ropivacaine 0.2% Injectable Solution; 0.9%sodium chloride
Intervention type(s): Drug; Drug
Intervention description(s): 20 mL 0.5% ropivacaine was injected into the PENG block
20 mL 0.5% ropivacaine was injected into the Adductor Canal block; 20 mL 0.9% sodium chloride was injected into the PENG block
20 mL 0.5% sodium chloride was injected into the Adductor Canal block
Other intervention name(s): Ropimol; normal saline
Intervention MeSH terms: Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized, double-blind, placebo-controlled
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: iPACK; Adductor Canal Block; pain management; multimodal analgesia; peripheral nerve block; knee arthroplasty
Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics (PKs) of ZYDPLA1 Following Oral Administration in Healthy Volunteers
Condition: Diabetes Mellitus
Study type: Interventional
Phase: Phase 1

Summary: 
      This First in Human (FIH) Phase I study intends to evaluate the safety, tolerability,
      pharmacokinetics and pharmacodynamics of ZYDPLA1 in normal healthy adult volunteers.
    

Detailed description: 
      Glucose-dependent insulinotropic polypeptide (GIP) and Glucagon-like peptide (GLP-1) are
      incretin hormones, which stimulate glucose dependent insulin secretion, inhibit glucagon
      secretion, delay gastric emptying, suppress appetite and improve peripheral glucose uptake
      and disposal. Dipeptidyl peptidase-IV (DPP-IV) is a serine protease, which selectively
      cleaves the first two amino acids of GIP and GLP-1 thereby making it inactive. Inhibition of
      DPP-IV activity elevates endogenous GIP, GLP-1 and insulin levels thereby improving glucose
      excursion and exhibits antidiabetic activity. Since no orally active GLP-1 agonists are
      available, clinically orally bioavailable DPP-IV inhibitors hold great potential for the
      treatment of type 2 diabetes mellitus.

      Cadila Healthcare Ltd. developed a novel and orally bioavailable DPP-IV inhibitor (ZYDPLA1).
      In-vitro studies confirm selective DPPIV inhibitory activity of the ZYDPLA1. Pre-clinical in
      vivo pharmacodynamic, absorption, distribution, metabolism and excretion (ADME) &
      toxicological studies showed the promising antidiabetic activity, good exposure and safety
      profile of ZYDPLA1(in various animal models).

      Hence a randomized, double-blind, placebo-controlled first in man trial proposed to evaluate
      the safety and tolerability of ZYDPLA1 in healthy volunteers.

      This study included 4 plans:

      i) single dose escalation study ii) multiple dose escalation study, iii) gender effect study
      and iv) food effect study.
    

Intervention name(s): ZYDPLA1 tablet; Placebo tablet
Intervention type(s): Drug; Drug
Intervention description(s): The oral dose of ZYDPLA1 tablet administered with 240 ± 10 mL of water at ambient temperature.; The oral dose of placebo tablet administered with 240 ± 10 mL of water at ambient temperature.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: Healthy Subject; ZYDPLA1; DPPIV inhibitor; Pharmacokinetics; Safety
Hydroxychloroquine in Patients With Stage III or Stage IV Melanoma That Can Be Removed by Surgery
Condition: Melanoma (Skin)
MeSH terms: Melanoma
Study type: Interventional
Phase: Early Phase 1

Summary: 
      RATIONALE: Studying samples of blood, tumor tissue, and skin in the laboratory from patients
      with melanoma receiving hydroxychloroquine may help doctors understand the effect of
      hydroxychloroquine on biomarkers.

      PURPOSE: This early phase I trial is studying hydroxychloroquine in patients with stage III
      or stage IV melanoma that can be removed by surgery.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  To characterize the effects of hydroxychloroquine (HCQ) on the modulation of markers of
           autophagy, as measured by p62, Beclin1, LC3, and GRp170 expression, in pre- and
           post-treatment tumor biopsy samples, skin samples, and peripheral blood mononuclear cell
           samples from patients with stage III or IV melanoma undergoing palliative or curative
           surgery.

      Secondary

        -  To determine whether the steady-state plasma concentration of HCQ correlates with
           observed trends in induced markers of autophagy.

        -  To determine the potential mechanisms of antitumor effect of HCQ, as measured by a
           reduction in tumor cell proliferation (Ki-67 and mitotic rate) or an increase in
           apoptosis (activated caspase-3 and TUNEL assays) in melanoma specimens.

      OUTLINE: Patients receive oral hydroxychloroquine twice daily for 14 days in the absence of
      disease progression or unacceptable toxicity. Patients then undergo surgery.

      Blood, tumor tissue, and skin samples are collected for pharmacokinetic and correlative
      laboratory studies. Expression of p62, Beclin1, LC3, and GRp170 (autophagy markers) is
      analyzed.
    

Intervention name(s): hydroxychloroquine
Intervention type(s): Drug
Intervention description(s): 200 mg twice daily in the first ten patients. If the first ten patients tolerate this dosage schedule (200 mg bid) without significant side effects (Grade 3 or greater gastrointestinal upset, skin toxicity, myopathy or any visual disturbances whatsoever), the second ten patients will be enrolled at a dose of 400 mg bid
Intervention MeSH terms: Hydroxychloroquine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage III melanoma; stage IV melanoma
A Study to Evaluate the Safety and Immunogenicity of EV71 Vaccine
Condition: Enterovirus Infection
MeSH terms: Enterovirus Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is aims to evaluate the safety, reactogenicity and immunogenicity of EV71 vaccine
      at a 0.25ml or 0.5ml dose in health volunteers
    

Detailed description: 
      This is a phase I, prospective, randomized, open-label, two-center study. A total 60 healthy
      volunteers will be screened for baseline characteristic inclusion/exclusion criteria after
      providing a written informed consent. Eligible subjects will be recruited and equally
      randomized to either receive 2 doses of EV71 vaccine 0.25ml or 0.5ml. All subjects should be
      followed till Day 210.
    

Intervention name(s): EV71 vaccine
Intervention type(s): Biological
Intervention description(s): Two-vaccination 0.25ml or 0.5ml dose assigned to two groups.
Other intervention name(s): EV71 vac
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Chloroquine as a Modulator of T Cell Immune Activation
Condition: HIV
Study type: Interventional

Summary: 
      This study will evaluate the effect of chloroquine in individuals infected with HIV.
      Researchers will aim to determine if chloroquine treatment in participants whose viral loads
      are suppressed on combination antiretroviral therapy (ART), results in improved immune
      activation and CD4 cell recovery.

      The study will recruit 20 individuals and will last approximately 44 weeks. Eligible
      participants will receive an oral dose of chloroquine (250 mg) once daily from week 8 through
      week 32. All participants will be asked to have rectal biopsy samples (week 0 and week 32) to
      study T cell immune activation in the mucosa rectal site.
    

Detailed description: 
      Clinical data has identified chloroquine as a potential modulator of immune activation. The
      study's dose of chloroquine is the same as the dose recommended for patients having
      autoimmune diseases. In these autoimmune cases, a daily dose of chloroquine at 250 mg for 12
      weeks has shown improvement in symptoms and decreases in inflammatory cytokines synthesis and
      a reduction in TLR -mediated immune activation. Study findings could help provide information
      about where and under what circumstances chloroquine treatment may reduce T cell activation
      and help restore circulating CD4 T cells.
    

Intervention name(s): Chloroquine
Intervention type(s): Drug
Intervention MeSH terms: Chloroquine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chloroquine; T cell immune activation; CD4 recovery; HIV
Bifocal Lenses In Nearsighted Kids
Condition: Refractive Errors
MeSH terms: Refractive Errors
Study type: Interventional

Summary: 
      This study will evaluate the use of two different bifocal contact lens add powers to prevent
      further nearsighted progression in children ages 7 to 11 years old. It is theorized that the
      profile of the bifocal lenses will decrease the amount of change in nearsightedness that the
      children experience.
    

Detailed description: 
      The primary goal of this project is to determine whether a commercially available soft
      bifocal contact lens with a distance-center design can slow myopia progression in children.
      Using soft bifocal contact lenses to manipulate the peripheral optics of the eye is a novel
      use for a standard contact lens that may keep children from becoming as nearsighted as they
      would otherwise. Secondary goals are to determine whether the amount of myopic defocus
      imposed on the peripheral retina by soft bifocal contact lenses is associated in a
      dose-dependent manner with slowed myopic progression and to determine whether peripheral
      myopic blur acts to slow eye growth locally or globally. These important pieces of
      information will enable investigators to learn about the role of peripheral optics for
      regulating eye growth, which could ultimately lead to optimization of optical signals to slow
      myopia progression. Ultimately, the information could be used to design optical devices to
      prevent the onset of myopia in young children.

      Slowing myopia progression or eventually preventing myopia onset could potentially affect
      approximately 60 million children in the United States alone. While the consequences of
      myopia are rarely sight-threatening, the quality of life for myopic patients is negatively
      affected and the health care costs to treat myopia are astronomical (approximately $4.6
      billion in 1990). The National Eye Institute recognizes the need to "evaluate the efficacy of
      potential treatments for delaying the onset or for slowing the progression of myopia, such as
      lenses that alter peripheral defocus."

      Using a common treatment of myopia (contact lenses) to potentially slow myopia progression
      and to learn about optical signals that regulate eye growth is a very novel approach to
      solving a problem that affects a large proportion of people in the United States.
    

Intervention name(s): Biofinity Multifocal D +1.50 add; Biofinity Multifocal D +2.50 add; Biofinity
Intervention type(s): Device; Device; Device
Intervention description(s): This is a monthly disposable contact lens commercially available from CooperVision; This is a monthly disposable contact lens commercially available from CooperVision; This is a monthly disposable spherical contact lens commercially available from CooperVision
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: pediatrics; refractive error - myopia; contact lenses; intervention
Co-Administration of MK-4618 With Antihypertensive Agents (MK-4618-010)
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the safety and tolerability of MK-4618 when coadministered with
      antihypertensive agents and will evaluate changes in blood pressure following
      co-administration of MK-4618 with a beta blocker and a vasodilator. The primary hypothesis of
      the study is that MK-4618 does not result in a clinically meaningful change in systolic blood
      pressure relative to placebo when co-administered with a beta-blocker or with amlodipine.
    


Intervention name(s): MK-4618; Placebo for MK-4618; Metoprolol; Amlodipine
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Once daily oral dose of MK-4618 100 mg (two 50 mg tablets) on Days 1 through 7; Once daily oral dose of placebo for MK-4618 100 mg (two 50 mg tablets) on Days 1 through 7; Previously prescribed daily dose of open-label metoprolol for the duration of the study; Previously prescribed daily dose of open-label amlodipine for the duration of the study
Other intervention name(s): Toprol-XL; Norvasc
Intervention MeSH terms: Metoprolol; Amlodipine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study of Caldolor in Hospitalized Febrile Pediatric Patients
Condition: Fever
MeSH terms: Hyperthermia; Fever
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study of Caldolor administered to febrile hospitalized
      pediatric patients every 6 hours for 24 hours is to determine the clinical equivalence of a
      single dose of Caldolor compared to acetaminophen (paracetamol; APAP) for the treatment of
      fever as measured by the AUC Tº within the first 6 hours of treatment (as compared to a
      target temperature of 98.6ºF [37.0ºC]).
    


Intervention name(s): Caldolor
Intervention type(s): Drug
Intervention MeSH terms: Ibuprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Docosahexaenoic Acid (DHA) To Prevent Development of Cognitive Dysfunction Due to Chemotherapy
Condition: Cognitive Dysfunction
MeSH terms: Cognitive Dysfunction
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this study is to determine if a high dose of DHA begun prior to and continued
      during neo-adjuvant chemotherapy (chemotherapy given prior to surgery) is likely to prevent
      or lessen chemotherapy induced cognitive dysfunction.
    

Detailed description: 
      Chemotherapy is often associated with problems of cognitive functioning such as decision
      making, learning, and memory. These symptoms, collectively referred to here as cognitive
      dysfunction can appear as early as the first few months after starting chemotherapy and may
      persist long after chemotherapy and anti-hormone therapy, if any, is completed.

      Once developed there is no satisfactory treatment for cognitive dysfunction although
      cognitive retraining and exercise may improve symptoms and/or function; at least for some.

      Omega-3 fatty acids derived from ocean fish are a new potential preventative treatment
      against development of cognitive problems which can arise in some individuals during
      chemotherapy treatment. In doses of 1-2 grams per day it has been found to improve some
      aspects of cognitive function in healthy adults who have low DHA dietary intake. It has also
      been shown to improve some aspects of function in individuals with a mild reduction in
      cognitive ability but not for those with marked impairment.

      Participation in this study will last about 12 months. Participants will make visits to the
      study site for both standard of care visits and additional study-related visits. Participants
      will be randomized (randomly assigned; like flipping a coin) to one of two groups. Neither
      the Investigator nor the participant will know the assigned treatment.
    

Intervention name(s): DHA; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 4 capsules of 400 mg DHA daily; Matched, blinded placebo
Other intervention name(s): Docosahexaenoic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: DHA; Omega-3; neoadjuvant chemotherapy; chemotherapy; breast cancer
Dental Restorations Effect on Oxidative Status of the Gingival Crevicular Fluid
Condition: Pharmacological Action
Study type: Interventional

Summary: 
      The goal of the study was to ascertain the influence of dental caries and teeth position as
      well as the type and amount of the applied dental materials (DMs) on the oxidative stress
      (OS) status in gingival crevicular fluid (GCF).
    

Detailed description: 
      Six DMs were tested by investigators, each sealed in one session: amalgam (Amg), zinc
      phosphate cement (ZnPhC), zinc polycarboxylate cement (ZnPoC), glass ionomer cement (GIC) and
      composites, Tetric EvoCeram (TEC) and Beautifil (BF).

      The study included 88 dental outpatients. Oxidative stress parameters, including
      malondialdehyde (MDA), glutathione (GSH) and total superoxide dismutase (tSOD) activity were
      measured in GCF, before (day 0) and after treatment (7th and 30th day).

      Antagonistically positioned healthy teeth were used as a control.
    

Intervention name(s): Amalgam placement; Tetric EvoCeram placement; Beautifil placement; Zinc phosphate cement placement; Zinc polycarboxylate cement placement; Glass ionomer cement placement
Intervention type(s): Procedure; Procedure; Procedure; Procedure; Procedure; Procedure
Intervention description(s): Before the Amg was sealed GCF was taken, and then taken again on the 7th and 30th days after the applied treatment.; Before the TEC was sealed GCF was taken, and then taken again on the 7th and 30th days after the applied treatment.; Before the BF was sealed GCF was taken, and then taken again on the 7th and 30th days after the applied treatment.; Before the ZPhC was sealed GCF was taken, and then taken again on the 7th and 30th days after the applied treatment.; Before the ZPoC was sealed GCF was taken, and then taken again on the 7th and 30th days after the applied treatment.; Before the GIC was sealed GCF was taken, and then taken again on the 7th and 30th days after the applied treatment.
Intervention MeSH terms: Zinc
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: According to Black's Classification Criteria, patients were classified into four groups (K2 - K5). The number of patients within those groups were as follows: K2 (n=58), K3 (n=10), K4 (n=6) and K5 (n=14).
Six different DMs were used in this study. The type of DM to be used for each patient was determined in relation to the dental lesion degree. DM placement was performed in one session and only one type was used per patient. Accordingly, 6 groups (arms) of dental patients (Amg, ZnPhC, ZnPoC, GIC, TEC and BF) were formed.
Parameters of OS (MDA, GSH and tSOD) were measured in the GCF of the patients both before (day 0) and after treatment (on the 7th and 30th day).
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: dental restorations; gingival crevicular fluid; glutathione; lipid peroxidation; superoxide dismutase
Dexmedetomidine and Subarachnoid Haemorrhage
Condition: Subarachnoid Hemorrhage; Aneurysm
MeSH terms: Subarachnoid Hemorrhage; Aneurysm; Hemorrhage
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to investigate how dexmedetomidine affects static and dynamic
      autoregulation, intracranial pressure (ICP) and cerebral oxygenation in aneurysmal
      subarachnoid haemorrhage (SAH) patients.
    

Detailed description: 
      Dexmedetomidine is a selective α2-agonist which induces sedation, anxiolysis and analgesia
      without respiratory depression. These effects, as well as neuroprotective properties in
      experimental studies would be ideal in neuroanaesthesia and in neurocritical care. Poor grade
      SAH patients are treated in intensive care units (ICU). These patients are sedated often with
      propofol. However, to assess the patient's neurology, the propofol sedation must be stopped
      and the wakening of the patient may take time. Dexmedetomidine would be more advantageous,
      allowing wakening during the infusion. However, the effects of dexmedetomidine on cerebral
      autoregulation are unknown in SAH patients.

      15 SAH patients requiring sedation, mechanical ventilation and ICP monitoring will be rolled
      in to the study.
    

Intervention name(s): Dexmedetomidine infusion
Intervention type(s): Drug
Intervention description(s): Both static and dynamic autoregulation are assessed first during propofol infusion, before commencement of dexmedetomidine infusion. Dexmedetomidine infusion is commenced with a dose of 0.7 μg/kg/h and propofol infusion is stopped concomitantly. After 2 hours dexmedetomidine infusion, the static and dynamic autoregulation are assessed. If there are no signs of worsening of autoregulation, then the dexmedetomidine infusion is increased to 1 μg/kg/h and after 2 hours the static and dynamic autoregulation are assessed again. However, if autoregulation worsens during dexmedetomidine infusion, it will be stopped and further testing with dexmedetomidine will not be carried out. If autoregulation does not worsen with the 1 μg/kg/h dose then the dose will be increased to 1.4 μg/kg/h. After 2 hours infusion the dynamic and static autoregulation are assessed again.
Blood samples for determining dexmedetomidine plasma concentration are collected alongside with the autoregulation assessments
Intervention MeSH terms: Dexmedetomidine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Subarachnoid hemorrhage; Dexmedetomidine; Autoregulation; Intracranial pressure; Cerebral oxygenation