bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Investigate an Immunomodulatory Therapy in Adult Patients With Perennial Allergic Rhinoconjunctivitis
Condition: Perennial Allergic Rhinoconjunctivitis; House Dust Mite Allergy
MeSH terms: Dust Mite Allergy; Conjunctivitis; Conjunctivitis, Allergic; Hypersensitivity
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to test the efficacy of the combination treatment AllQbG10 in
      patients with perennial allergic rhinoconjunctivitis due to house dust mite allergy in a
      double-blind placebo-controlled setting
    


Intervention name(s): CYT005-AllQbG10 (combination of house dust mite allergen extract with CYT003-QbG10); House dust mite allergen extract in combination with CYT003-QbG10-placebo
Intervention type(s): Drug; Drug
Intervention description(s): subcutaneous injections at 8 visits; subcutaneous injections at 8 visits
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Clinical Study to Evaluate Renal Hemodynamic Responses to Aliskiren in Patients With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      The study objective was to assess the effect of single and multiple doses of aliskiren on
      renal plasma flow, glomerular filtration rate and to compare the effects of single and
      multiple doses of aliskiren versus captopril or irbesartan on renal blood flow, glomerular
      filtration rate, and retinal blood flow in patients with type 2 diabetes mellitus.
    


Intervention name(s): Aliskiren; Irbesartan; Captopril
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Aliskiren 300 mg tablets; Irbesartan 300 mg tablets; Captopril 25 mg tablet
Other intervention name(s): SPP100
Intervention MeSH terms: Irbesartan; Captopril
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Type 2 diabetes mellitus; renal disease; hypertension; renal blood flow; retinal blood flow; aliskiren; irbesartan; captopril
Longitudinal Study of Patients With Opioid-Induced Constipation
Condition: Patients With Opioid Induced Constipation
MeSH terms: Constipation; Opioid-Induced Constipation
Study type: Observational

Summary: 
      This prospective hybrid longitudinal study was conducted in the United States (US), Canada,
      the United Kingdom (UK), and Germany. To obtain the most complete and comprehensive
      understanding of the burden of opioid-induced constipation (OIC) in these countries, this
      study used a combination of web-based, longitudinal patient survey, retrospective data
      abstraction from medical records, and a prospective physician survey.

      The primary objective of this study was to estimate the rate of inadequate response to
      laxatives (LIR), which was defined as having sufficient laxative use (at least one laxative
      use ≥ four times per reference period), and inadequate response (defined as fewer than three
      bowel movements (BMs) OR at least one of the following symptoms on the Patient Assessment of
      Constipation Symptoms (PAC-SYM) measure scored as moderate, severe or very severe: BMs too
      hard, straining to have a BM, feeling like you didn't "finish" a BM, and feeling like you had
      to pass a BM but could not), in a cohort of non-cancer pain and cancer pain (separately)
      participants with OIC, by country and overall.

      The secondary study objectives are as follows:

        1. To estimate the rate of LIR for two subgroups: 1xLIR and 2xLIR. 1xLIR was defined as use
           of at least one laxative agent ≥ 4 times in the reference period while 2xLIR was defined
           as the use of at least two laxative agents, each used ≥ 4 times in the reference period;

        2. To describe the baseline demographic and clinical characteristics, including prior
           health status, comorbidities, constipation-related GI symptoms, and concomitant
           medications of patients with OIC;

        3. To describe drug utilization and self-management of OIC;

        4. To describe the pre-index and post-index healthcare resource utilization and estimate
           costs associated with the diagnosis, treatment, and general management of OIC (including
           laxative use) and events attributed to OIC, including both direct and indirect costs;

        5. To describe patient-reported impact of OIC on health-related quality of life,
           productivity, and pain management;

        6. To describe patient-reported treatment satisfaction with laxative use; and

        7. To describe physician-reported awareness of OIC and symptoms and understanding of
           patient-reported impact of OIC.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The target population consists of patients who have been on daily opioid therapy for ≥ 4
        weeks for the treatment of chronic non-cancer or cancer pain and who have opioid-induced
        constipation, as per patient history.
      
Keywords: opioid induced constipation in patients without cancer and with cancer
Post-Traumatic Stress Symptoms (PTSS) in Transplant Recipients
Condition: Solid Organ Transplant Recipients; Parent(s)/Guardian of Referenced Transplant Recipients
Study type: Observational

Summary: 
      This study is conducted to better understand Post-Traumatic Stress Symptoms (PTSS) in
      adolescent transplant recipients and their parent/guardian and to see if PTSS play a role in
      the way adolescent transplant recipients take their prescribed medicine.

      Target population: medically stable adolescent solid organ (e.g., heart, kidney, liver, lung,
      small bowel) transplant recipients and their parent(s)/guardian.
    


Intervention name(s): Assessment of adherence, mental health, behavioral, quality of life and biological constructs
Intervention type(s): Other
Observational model: Cohort
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Adolescent transplant recipients at risk for non-adherence and can reliably answer
        self-report questionnaires.
      
Biospecimen description: 
      Blood
    
Keywords: Transplant recipients; Adolescents; Post-Traumatic Stress Symptoms (PTSS); Transplant Recipient and Family Impact(s)
A Clinical Trial Using Metronomic Oral Low-dose Cyclophosphamide Alternating With Low-dose Oral Methotrexate With Continuous Celecoxib and Weekly Vinblastine in Children and Adolescents With Relapsed or Progressing soliD Tumours.
Condition: Survival Without Progression
MeSH terms: Disease Progression
Study type: Interventional
Phase: Phase 2

Summary: 
      To establish the anti-tumour effect of this metronomic combination regimen defined by
      progression-free survival (PFS) after two cycles of treatment (4 months) and 12 months of
      treatment, as well as response rate after any number of cycles of treatment ("best
      response").

      To define the safety profile of the combination. To characterize pharmacodynamics of the drug
      combination with the use of angiogenic markers (CEP, CEC, microparticles).
    

Detailed description: 
      Multi-center, combination phase II study, open-label, non-comparative, non-randomized.

      All progressive or recurrent solid tumours will be included in the Phase II study, provided
      there are no curative options anymore.

      Total expected number of patients (minimum maximum): 54 to 90 (2-stage design)
    

Intervention name(s): celecoxib, Vinblastine, Cyclophosphamide , methotrexate ,
Intervention type(s): Drug
Intervention MeSH terms: Celecoxib; Cyclophosphamide; Methotrexate; Vinblastine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study Evaluating 5 Doses of RPL554 and Placebo in COPD Patients Via a Dry Powder Inhaler
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to investigate 5 doses of RPL554 and placebo, administered by
      dry powder inhaler (DPI), in patients with moderate to severe chronic obstructive pulmonary
      disease (COPD).
    

Detailed description: 
      The study will consist of two parts. Part A is a parallel group, placebo-controlled single
      dose study to ascertain the Pharmacokinetics (PK) profile, safety and bronchodilator effect
      of RPL554 administered via dry powder inhaler (DPI). Five of the 6 treatment arms will be
      double-blind and one will be single-blind (due to the different number of capsules
      administered). Part B is a placebo-controlled, complete block cross-over, repeat dose study
      to assess the bronchodilator effect of repeat doses of RPL554 delivered via a DPI.
    

Intervention name(s): Part A: RPL554; Part B: RPL554; Placebos
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 1 dose of either 50mcg/100mcg/1500mcg/3000mcg/6000mcg or placebo via dry powder inhaler; Patients will receive 4 or 5 repeat dose treatments in crossover fashion - doses will be confirmed after Part A; Part A: 1 dose of either 50ncg/100ncg/1500ncg/3000ncg/6000ncg or placebo via dry powder inhaler.
Part B: Patients will receive 4 or 5 repeat dose treatments in crossover fashion - doses will be confirmed after Part A.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Regulation of KATP Channels and Na+/K+ ATPase in Relation to Fatigue Development
Condition: Insulin Resistance
MeSH terms: Insulin Resistance; Fatigue
Study type: Interventional

Summary: 
      To investigate the role of ATP sensitive K+ potassium channels and the Na+/K+ pump in the
      development of fatigue in healthy and in insulin resistant subjects.
    


Intervention name(s): Placebo; Nicorandil
Intervention type(s): Drug; Drug
Intervention description(s): placebo tablet; 20 mg nicorandil (Ikorel, Sanofi Winthrop Industrie; NIC)
Intervention MeSH terms: Nicorandil
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: skeletal muscle; muscle fatigue; ion handling
Placental Transfusion in Term Infants: A Pilot Study
Condition: Anemia
Study type: Interventional

Summary: 
      The proposed study is a pilot prospective controlled trial to measure the blood volume left
      in the placenta after varying cord clamping times when the infant is placed skin-to-skin on
      the maternal abdomen. Delaying cord clamping has been shown to decrease anemia in infants.
      However, the best way to get the most blood to the baby is not known. The practice of cord
      clamping at birth is not the same among doctors and midwives and we do not know the effect of
      putting he baby on the mother's abdomen.
    

Detailed description: 
      The proposed study is a pilot prospective controlled trial to measure the placental residual
      blood volume after varying cord clamping protocols when the infants are placed skin-to-skin
      on the maternal abdomen. The study assessed compliance of the providers with the different
      protocols. Placental transfusion (PT) has been shown to increase infant body iron stores at 6
      months of age without increasing adverse outcomes. However, the optimal protocol to achieve
      adequate placental transfusion is not known. The practice of cord clamping at birth is not
      uniform among obstetrical providers because adequate evidence to support early or late cord
      clamping has been lacking.

      Women were eligible to enroll in the study if they had no pregnancy complications, did not
      smoke, planned to breastfeed, and planned to deliver vaginally between 37 and 416/7 weeks.
      Women were enrolled prenatally on the labor and delivery unit. At birth, women were assigned
      to one of four cord clamping/milking groups. A cohort of infants with immediate cord clamping
      serves as reference group. Infants had blood samples drawn with the routine newborn screening
      blood samples done at 36 to 48 hours. Information on infant health and feeding was completed
      through an in-hospital visit to the mother and by home visit at two weeks of age. The primary
      outcome measures were placental residual blood volume and compliance with the various
      assigned cord clamping protocols. It was expected that infants with delayed cord clamping or
      cord milking would have less placental residual blood volume and that most providers would
      comply with the various random assignments.
    

Intervention name(s): cord clamping at 2 minutes; cord clamping at 5 minutes; cord milking
Intervention type(s): Procedure; Procedure; Procedure
Allocation: Non-Randomized
Intervention model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: umbilical cord clamping; Placental residual blood volume; hematocrit; hemoglobin; bilirubin
Study to Evaluate the Efficacy of N-acetylcysteine (NAC) in the Treatment of the Common Cold and Cough
Condition: Common Cold Associated With Cough
MeSH terms: Common Cold; Cough
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed to improve knowledge regarding the initial effectiveness of
      N-acetylcysteine (NAC) on cold and cough symptoms.
    


Intervention name(s): N-acetylcysteine; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: N-acetylcysteine; adults; cough and cold
An Analgesia Protocol for Acute Renal Colic in the Emergency Department
Condition: Kidney Stone
MeSH terms: Kidney Calculi; Emergencies; Renal Colic
Study type: Interventional

Summary: 
      An analgesia protocol for acute renal colic will lead to faster significant reductions in
      pain than prior practice.
    

Detailed description: 
      A retrospective study was performed that assessed the time to significant analgesia and
      medications used to achieve analgesia in the DHMC ED. Based upon this a prospective pain
      management protocol was designed and we will track the difference in time to significant pain
      relief between the two groups.
    

Intervention name(s): Toradol; Morphine
Intervention type(s): Drug; Drug
Intervention MeSH terms: Ketorolac Tromethamine; Morphine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Renal colic, pain, protocol, emergency department
Effects of Oral L-Arginine on Chronic Hypertension in Pregnancy
Condition: Hypertension in Pregnancy
MeSH terms: Hypertension, Pregnancy-Induced; Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the effects of oral L-Arginine in pregnant women
      with chronic hypertension.
    


Intervention name(s): L-Arginine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral L-Arginine 2g, twice a day for 14 weeks; Placebo 2 g twice a day for 14 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: chronic hypertension in pregnancy; chronic Hypertension
Study to Evaluate the Safety and Efficacy of CTP-543 in Adults With Moderate to Severe Alopecia Areata
Condition: Alopecia Areata
MeSH terms: Alopecia; Alopecia Areata
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the safety and efficacy of CTP-543 on hair loss in adults with
      chronic, moderate to severe alopecia areata.
    

Detailed description: 
      This is a double-blind, randomized, placebo-controlled multi-center study consisting of 3
      cohorts to assess the safety and efficacy of CTP-543. Each Cohort will be initiated
      sequentially in ascending dose order. Participants will be randomized to either an active
      dose of CTP-543 or placebo for a 24-week treatment period.
    

Intervention name(s): CTP-543; CTP-543 matching placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered as tablets.; Administered as tablets.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Efficacy of Ginger in the Prevention of Abdominal Distention in Post Cesarean Section Patient
Condition: Post Cesarean Section Patient
MeSH terms: Dilatation, Pathologic
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine ginger is effective in the prevention of abdominal
      distention in post Cesarean section patient.
    


Intervention name(s): Ginger; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Transmuscular Quadratus Lumborum Block Plus Pericapsular Injection vs Pericapsular Injection
Condition: Hip Pain Chronic
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this research study is to compare two different treatment options on their
      effectiveness to reduce post-operative pain, narcotic (opioid pain medication) usage and
      recovery time in patients undergoing primary hip arthroscopy surgery.

      The first treatment option is a Transmuscular Quadratus Lumborum (TQL) block plus hip
      incision site (Pericapsular) Injection. The TQL block is an ultrasound guided injection
      between the quadratus lumborum and the psoas muscles in the back. The anesthesiologist will
      perform the TQL block The second treatment option is only a hip incision site (Pericapsular)
      Injection. In this group, the surgeon will inject local anesthetic into the incision or hip
      portal sites to decrease sensation.
    

Detailed description: 
      This is a phase IV, randomized, single-blind, single-center study comparing postoperative
      pain, opioid usage and Post-Anesthesia Care Unit (PACU) recovery time for patients who
      receive a Transmuscular Quadratus Lumborum block (TQLB) plus pericapsular injection versus
      pericapsular injection (PCI) undergoing primary hip arthroscopy.
    

Intervention name(s): Transmuscular Quadratus Lumborum Block; Pericapsular injection; Bupivacaine Hydrochloride
Intervention type(s): Procedure; Procedure; Drug
Intervention description(s): Transmuscular Quadratus Lumborum Block (TQLB) is a relatively new block that targets thoracic and lumbar nerves. The decrease in sensation means a decrease in pain. The TQL block will be preformed in addition to an incision-site injection (on hip), called pericapsular injection. The potential risks associated with the Transmuscular Quadratus Lumborum Block (TQLB) include nerve damage and infection at injection site. In addition, there can be temporary sensory and motor loss, depending on the dosage, site of injection and duration of the nerve block. However, the amount (30mL) used in this study meets FDA dosage-regulations for this medication.; Pericapsular injection (PCI) of 20 mL of 0.25% Bupivacaine HCL (numbing medication) into the incision-site (hip portal sites) to decrease sensation. The potential risks associated with the pericapsular injection include bleeding, infection at injection site and local anesthetic toxicity however, the likelihood is low due to the expertise of the surgeon preforming the injection and the sterile environment and good clinical practice from clinicians, which reduces the likelihood of infection.; Bupivacaine used for this study is the standard of care for both TQLB and PCI. Pericapsular injection (PCI) contains 10 mL of 0.25% Bupivacaine HCL which will be injected through the anterolateral portal while the additional 10 mL will be injected through the mid-anterior portal.
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Efficacy of EPA-enriched Supplement in Malnourished Head and Neck Cancer Patients Undergone Surgery
Condition: Head and Neck Cancer
MeSH terms: Head and Neck Neoplasms; Malnutrition
Study type: Interventional

Summary: 
      The purpose of this study is to study the effects of EPA-enriched supplement compared with
      conventional supplement in malnourished head and neck cancer patients undergone surgery.
      Primary outcome is perioperative weight changing.
    

Detailed description: 
      To study the effects of EPA-enriched supplement compared with conventional supplement in
      malnourished head and neck cancer patients undergone surgery. The patients are divided into 2
      groups receiving the different formula supplements. The both supplements are isocaloric. The
      patients receive the supplement for 3 weeks (1 week prior to surgery and 2 weeks post
      surgery) Primary outcome is perioperative weight changing. Secondary outcomes are body
      compositions, hospital stay days, complication and co-morbidity.
    

Intervention name(s): EPA-enriched supplement; standard formula supplement
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): EPA-enriched supplement is given to the patients for 3 weeks (1 week prior to surgery and 2 weeks post surgery). The supplement composes of 2.2 gm of EPA and 630 kcal daily.; The standard formula supplement is given to the patients for 3 weeks (1 week prior to surgery and 2 weeks post surgery). The supplement is 630 kcal daily without EPA.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Malnourished; Head and Neck Cancer; Surgery