bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of the Effect on Glucose Control of AC2993 in Patients With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Non-Insulin-Dependent
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multicenter, randomized, blinded, placebo-controlled study to assess the effects on
      glucose control of AC2993 as compared to placebo in patients with type 2 diabetes. Patients
      will be randomized into one of two AC2993 treatment arms or to placebo treatment and will
      continue with their required existing diabetes medications (metformin and a sulfonylurea)
      throughout the study.
    


Intervention name(s): AC2993; AC2993; Placebo; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Placebo Lead In (0.02 mL) for 4 weeks / AC2993 5mcg (0.02 mL) for 4 weeks / AC2993 5mcg (0.02 mL) for 26 weeks - All are subcutaneously injected twice daily; Placebo Lead In (0.02 mL) for 4 weeks / AC2993 5 mcg (0.02 mL) for 4 weeks / AC2993 10 mcg (0.04 mL) for 26 weeks - All are subcutaneously injected twice daily; Placebo Lead In (0.02 mL) for 4 weeks / AC2993 5mcg (0.02 mL) for 4 weeks / AC2993 5mcg (0.02 mL) for 26 weeks - All are subcutaneously injected twice daily; Placebo Lead In (0.02 mL) for 4 weeks / Placebo mcg (0.02 mL) for 4 weeks / Placebo (0.04 mL) for 26 weeks - All are subcutaneously injected twice daily
Other intervention name(s): synthetic exendin-4; synthetic exendin-4
Intervention MeSH terms: Exenatide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Type 2 Diabetes Mellitis
Comparison of the Effects of Continuous Epidural Analgesia and Continuous Intravenous Analgesia on Postoperative Bowel Movement in Patients Undergoing Laparoscopic Gastrectomy
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators hypothesized that sympatholytic effect of epidural analgesia would
      attenuate the hemodynamic instability and decrease in the splanchnic blood flow caused by
      pneumoperitoneum during laparoscopic surgery. This study is to compare the effect of epidural
      analgesia and intravenous analgesia on postoperative bowel movement in patients undergoing
      laparoscopic gastrectomy.
    


Intervention name(s): continuous epidural analgesia; continuous intravenous analgesia
Intervention type(s): Other; Other
Intervention description(s): the continuous epidural analgesia group: epidural analgesia started from induction of anesthesia and continued for 48 h.; the continuous intravenous analgesia group: intravenous analgesia started from induction of anesthesia and continued for 48 h.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Bioequivalency Study of 7.5 mg Pilocarpine Tablets Under Fasting Conditions
Condition: Dry Mouth
MeSH terms: Xerostomia
Study type: Interventional

Summary: 
      The objective of this study was the bioequivalence of a Roxane Laboratories' Pilocarpine
      tablets, 7.5 mg, to SALAGEN® Tablets, 7.5 mg (MGI) under fasting conditions using a
      single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design.
    


Intervention name(s): Pilocarpine
Intervention type(s): Drug
Intervention MeSH terms: Pilocarpine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Acupuncture in the Treatment of Fatigue in Parkinson's Disease
Condition: Parkinson Disease; Fatigue
MeSH terms: Parkinson Disease; Fatigue
Study type: Interventional

Summary: 
      This study evaluates the efficacy of acupuncture in the treatment of fatigue in participants
      with Parkinson's Disease. Half of participants will receive real acupuncture while the half
      will receive placebo acupuncture.
    

Detailed description: 
      This will be a single centre, single blinded 2-group randomized controlled study, with
      participants receiving either verum acupuncture or placebo acupuncture.

      A retractable non-invasive placebo needle will be used in the placebo arm. Both the real and
      placebo needles have a fine needle body and copy handle and look exactly the same. However,
      the placebo needle has a retractable shaft and blunt tip. When pressed onto the skin, it
      telescopes into the handle and the blunt tip stays on the skin instead of penetrating it. The
      plastic tube with adhesive foot-plate is placed on the skin to hold it in place. The real
      needle, on the other hand, has a normal sharp tip which allows it to pierce the skin.

      The following acupoints will be needled: Stomach 36 (bilateral), Spleen 6 (bilateral), Kidney
      3 (bilateral), Large Intestine 4 (bilateral), Pericardium 6 (bilateral), and Conception
      Vessel 6. These points were chosen based on Traditional Chinese Medicine theory (which
      attributed fatigue to deficiencies of spleen, kidney and qi).

      Each acupuncture session will be based on a strict protocol, and conversation between
      acupuncturists and participants will be kept to a minimum.

      Participants will be assessed at 3 intervals:

        1. Week 0 (baseline)

        2. Week 5 (completion of intervention)

        3. Week 9 (4 weeks after completion of intervention
    

Intervention name(s): Acupuncture
Intervention type(s): Device
Intervention description(s): 10 sessions of acupuncture, twice a week over 5 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 2 arm study comparing acupuncture with sham
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Treatment of Idiopathic Pulmonary Fibrosis With Thalidomide
Condition: Idiopathic Pulmonary Fibrosis (IPF)
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The goal of this study is to determine whether thalidomide can stop the progression of
      fibrosis in IPF.

      The primary objective of this study is to determine the safety, feasibility and efficacy of
      400 mg of thalidomide administered daily for one year in patients with idiopathic pulmonary
      fibrosis (IPF) who have failed or are not candidates for treatment with corticosteroids
      and/or cytotoxic drugs.

      The study population will consist of patients with biopsy-proven moderate to severe IPF who
      have failed or are not candidates for standard therapy with corticosteroids and/or cytotoxic
      drugs.
    

Detailed description: 
      This is an unmasked Phase II, safety and efficacy trial of subjects with biopsy-proven IPF
      who have failed or are not candidates for standard therapy with corticosteroids and/or
      cytotoxic drugs. The study doctors are interested in studying the effects of the oral drug
      Thalomid(R) on IPF. Thalomid(R) (thalidomide) is an approved medication for Hansen's disease
      (leprosy). It is know to have anti-inflammatory effects and effects on fibrosis. It is hoped
      that Thalomid(R) may prevent progression of IPF.

      Thalidomide is investigational for this use, which means that it has not been approved by the
      U.S. Food and Drug Administration (FDA) for the treatment of IPF.

      The age range for this study is 50-80 years, inclusive. There are 6 visits over the 12 month
      period. These visits include physical exams, pregnancy tests (if applicable), several symptom
      scales and questionnaires about your pulmonary fibrosis, pulmonary function testing,
      x-rays,peripheral nerve testing, and blood tests including arterial blood gas measurements.
      You will be given the medication in capsule form every 28 days for a year. There is a set
      schedule for increasing the doses of the thalidomide every 2 weeks until it reaches the 400
      mg. dose that is being studies. A stool softener is also provided for each participant.

      All subjects must read, sign and follow a manual of precautions prepared by Celgene, the
      manufacturer of Thalomid(R), before enrolling in this study. This manual, containing the
      S.T.E.P.S.(R) precautions, will be given to all participants.

      This study is being conducted at the Johns Hopkins Medical Institutions located in Baltimore,
      Maryland.
    

Intervention name(s): Thalidomide
Intervention type(s): Drug
Intervention MeSH terms: Thalidomide
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of the Performance of Investigational Contact Lenses in a Presbyopic Population
Condition: Presbyopia
MeSH terms: Presbyopia
Study type: Interventional

Summary: 
      The objective of this study is to evaluate the performance of a novel multifocal lens system.
    


Intervention name(s): etafilcon A; lotrafilcon B
Intervention type(s): Device; Device
Intervention description(s): To be worn in a daily wear modality for a minimum of 6 hours per day.; Lenses will be worn in a reuseable modality; cleaned and disinfected each night.
Other intervention name(s): AirOptix Aqua Multifocal
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Contraceptive Efficacy of an Intravaginal Ring With LNG (Levonorgestrel) Over One Year in Healthy Women
Condition: Contraception
Study type: Interventional
Phase: Phase 3

Summary: 
      Purpose of the study is to investigate safety and contraceptive efficacy of an LNG-containing
      intravaginal ring.
    


Intervention name(s): Levonorgestrel (BAY98-7196)
Intervention type(s): Drug
Intervention description(s): Levonorgestrel 40 µg/d intravaginal ring (treatment for 365 days, 28 days wearing period for each ring)
Intervention MeSH terms: Levonorgestrel
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Pregnancy prevention
Motivational Interviewing to Improve Medication Adherence Among Hispanic Adults With Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will determine the effectiveness of motivational interviewing in improving
      antidepressant medication adherence among Hispanics.
    

Detailed description: 
      Depression is a serious mental illness characterized by symptoms that can interfere with a
      person's ability to work, study, eat, sleep, and enjoy activities that were once pleasurable.
      Studies have shown that people of Hispanic descent tend to underutilize mental health care
      services. Additionally, Hispanics have demonstrated lower compliance and completion rates for
      antidepressant treatment. This may be due to low socioeconomic status, lack of family
      financial support, and inadequate communication with mental health care providers.
      Motivational interviewing is a goal-oriented type of therapy that focuses on eliciting
      behavior change by identifying and mobilizing a person's values. This study will determine
      the effectiveness of culturally sensitive motivational interviewing in improving
      antidepressant medication adherence in Hispanics.

      Participants in this 6-month, open-label study will be randomly assigned to receive either
      motivational interviewing in addition to their antidepressant therapy or treatment as usual.
      All participants will first attend a 45-minute screening visit, which will include
      questionnaires and an interview about psychiatric symptoms, medication attitudes, and
      medication adherence behavior. Participants will also receive an electronic medication
      container that will record how consistently medication is taken. Participants assigned to
      motivational interviewing will then attend two 1-hour sessions of motivational interviewing
      over 2 consecutive weeks, followed by a third session 8 weeks later. The group assigned to
      treatment as usual will not partake in motivational interviewing, but will continue to
      receive their normal care. All participants will return to the study site for follow-up
      assessments, which will include measures of antidepressant adherence, at Months 2 and 5.
    

Intervention name(s): Motivational interviewing; Treatment as usual
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants assigned to motivational interviewing will attend two 1-hour sessions of motivational interviewing over 2 consecutive weeks, followed by a third session 8 weeks later. Motivational interviewing is a type of counselling. Each session is of approximately 1 hour duration.; Participants will continue with their normal treatment regimen as usual.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Dysthymia; Major Depression; Hispanics; Latinos; Motivational Interviewing; Adherence
The Impact of Mitotane Therapy on Serum Free Proteins in Patients With Adrenocortical Carcinoma
Condition: Adrenocortical Carcinoma
MeSH terms: Carcinoma; Adrenocortical Carcinoma
Study type: Observational

Summary: 
      This work will evaluate the effects of mitotane treatment on serum protein concentrations in
      patients treated for ACC with mitotane therapy and compare them to patients with an adrenal
      neoplasm and pregnant cohort. All of the individuals were treated at King's Hospital between
      April 2019 and June 2020. Proteins which will be evaluated during this study, include CBG and
      TBG.
    

Detailed description: 
      Background: Adrenocortical Carcinoma (ACC) is a rare malignancy of the adrenal cortex. The
      annual incidence of ACC is thought to be between 0.5-2.0 cases per million. Adjunctive
      therapy with mitotane may be offered post- surgically to minimise risk of recurrence.

      Aims: Evaluate the effects of mitotane treatment on serum protein concentrations in patients
      treated for ACC with mitotane therapy and compare to patients with an adrenal neoplasm and a
      pregnant cohort. Patients were treated at King's Hospital between April 2019 and June 2020.

      Methods: Cortisol, TFT's ACTH, CBG, TBG and gonadotrophins will be measured during the same
      venepuncture using serum samples. SPSS v27 and GraphPad Prism v9.3.1 will be used for
      analysis and illustrations. Thirty-five patients will be included, within ACC with mitotane,
      adrenal neoplasm or pregnant groups. Data will be tested for normality, described as Mean±
      SD, compared using paired sample t-test with 5% p-value for significance and 95% confidence
      interval (CI).
    

Intervention name(s): Mitotane
Intervention type(s): Drug
Intervention description(s): Individuals within the intervention group were on mitotane therapy as part of their ACC treatment.
Intervention MeSH terms: Mitotane
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        13 patients with an ACC on mitotane therapy will be investigated. Median age of the ACC and
        mitotane group: 63.0 (IQR: 46, 72.5) 22% of the studied population were Caucasian white,
        14.3% Southeast Asian, 11.4% Black Afro-Caribbean, 2.9% other and 2.9% missing. 6 (46.2%)
        of the patients with an ACC and on mitotane were male, and 7 (53.8%) were female. 6 (46.2%)
        individuals with an ACC and on mitotane had a stage of III and 7 (53.8%) had stage IV
        (according to the AJCC and ENSAT staging system).
      
Keywords: mitotane; adrenocortical carcinoma; ACC; serum free proteins; cortisol binding globulin; thyroid binding globulin
Management of Hypertension in the Early Postpartum: a Randomized Controlled Trial
Condition: Pregnancy-Induced Hypertension in Postpartum; Postpartum Pre-Eclampsia; Hypertension
MeSH terms: Eclampsia; Pre-Eclampsia; Hypertension, Pregnancy-Induced; Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      In hypertensive mothers, it is common in clinical practice to substitute methyldopa for
      another medication, such as captopril, immediately after delivery, which may, as a
      consequence, cause a rebound effect or an initial lack of blood pressure control until the
      new medication had a more complete action. Thus, the treatment of hypertension in the
      puerperium is generally guided by expert opinion and recommendations for guidelines, based on
      non-robust evidence. OBJECTIVE: To evaluate the control of blood pressure in postpartum women
      with hypertensive syndromes during pregnancy with the maintenance of the continued use of
      previously used methyldopa compared to switching from antihypertensive regimen to the use of
      captopril. METHOD: Randomized, double-blind, drug controlled clinical trial. EXPECTED RESULT:
      better pressure control with the continued use of methyldopa.
    

Detailed description: 
      Objective: To evaluate blood pressure control during the immediate postpartum in hypertensive
      women who had used methyldopa during pregnancy, comparing continuation of that drug with
      switching it for captopril. Methods: A single-blind, randomized clinical trial involving 180
      postpartum women with arterial hypertension who had previously used methyldopa during
      pregnancy at a minimum dose of 750 mg/day for at least one week prior to delivery. Following
      delivery, the patients were randomized either to continue with methyldopa (minimum dose 250
      mg, three times a day) (methyldopa group, n=90) or to switch to captopril (at an initial dose
      of 25 mg, three times a day) (captopril group, n=90). Logistic regression will be used to
      compare the groups regarding the potential to maintain blood pressure below 140/90 mmHg at
      over 50% of measurements postpartum.
    

Intervention name(s): Methyldopa 250 MG
Intervention type(s): Drug
Intervention description(s): maintaining postpartum the use of methyldopa 250 mg 01 tablet every 8 hours, being able to double the dose depending on pressure levels, up to 15 days postpartum
Intervention MeSH terms: Methyldopa
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Use of Standardized Algorithm for the Management of Epidural Analgesia for Labor and Delivery
Condition: Labor Pain
MeSH terms: Labor Pain
Study type: Observational

Summary: 
      Programmed Intermittent Epidural Bolus (PIEB) has become a standard technique for labour
      analgesia in many departments of anesthesia. Advantages to the former standard of care,
      continued epidural infusion (CEI), include reduced analgesic consumption , better maternal
      satisfaction and less occurrence of motor block . At Mount Sinai Hospital, the introduction
      of a bundle of changes in the management of labor analgesia including the use of PIEB, has
      resulted in an improvement of the quality of labor analgesia. This bundle of changes included
      labor catheter placement more often at L2/L3 interspace, more frequent use of fentanyl in the
      epidural loading dose, the implementation of a PIEB regimen and an increase in hourly
      baseline offer of local anesthetic.

      A recent before-and-after study conducted by the investigators, comparing the current
      practice with the previous practice, which was based on CEI, identified that the incidence of
      women experiencing pain >3 (scale 0-10) (40% vs 30%) and the number of nurse-administered
      top-ups (24% vs 3%) were significantly reduced. However, despite that significant
      improvement, some 30% of women undergoing epidural analgesia still experience pain NRS >3
      (NRS scale 0-10) during either first or second stage of labor.

      Although the health care team attempts to manage epidurals as standardized as possible, there
      is some variation in practice resulting from the many stakeholders involved in the labor
      analgesia management, including anesthesiologists, obstetricians, nurses and patients. The
      investigators hypothesized that our most recent results may be explained by the lack of
      standardization of the management of epidural analgesia and that a standardized epidural
      catheter placement and a management algorithm may improve the efficacy of our epidural
      analgesia regimen.

      The aim of this pilot study is to test the feasibility and efficacy of the use of a
      standardized algorithm for the management of labor epidural analgesia based on a PIEB
      regimen.
    


Intervention name(s): Algorithm
Intervention type(s): Other
Intervention description(s): Patients will have a printed algorithm to follow while they are in labour with an epidural for pain management.
Other intervention name(s): Epidural algorithm
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women admitted to the Labor and Delivery unit at Mount Sinai Hospital that request to
        receive epidural analgesia.
      
Keywords: programmed intermittent epidural bolus; epidural analgesia; labor epidural
Endothelial Function and Arterio-Venous Fistula Maturation
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Arteriovenous Fistula; Fistula
Study type: Observational

Summary: 
      An arterio-venous fistula is a surgical procedure that supports access for people undergoing
      hemodialysis (HD) for End Stage Renal Disease (ESRD). This observational pilot study seeks to
      better understand the factors that contribute to the successful maturation of an
      arterio-venous fistula. A primary aim of this study is to see if endothelial function (the
      biochemical events initiated by cells lining the arteries) is associated with successful
      maturation. Other aims include determining if pro-inflammatory markers in the blood or
      evidence of gene expression are associated with successful maturation.
    

Detailed description: 
      Current practice guidelines stipulate that 65% of all prevalent ESRD patients should receive
      HD through some sort of arterio-venous fistula (AVF). An AVF is a subcutaneous, permanent
      vascular access created surgically by connecting a vein with an artery and is the preferred
      mode of access due to lower rates of infection or thrombosis compared to prosthetic grafts or
      tunneled lines. An AVF is mature if it can sustain high quality HD. However, rates of primary
      failure (the inability of an AVF to sustain HD) are high, ranging from 40-70%. Traditional
      coronary risk factors such as hypertension, hypercholesterolemia, and diabetes mellitus, have
      limited ability to allow surgeons to predict which AVFs will mature.

      One possible explanation involves vascular remodeling, the structural changes which occur in
      a blood vessel in response to hemodynamic stimuli. The endothelial, lying at the interface of
      the vessel wall and flowing blood, is a "biosensor", responding to changes in blood flow and
      pressure. It initiates a complex biological response including cellular proliferation and
      migration, matrix degradation, and cellular apoptosis. This longitudinal, observational study
      hypothesizes that endothelial function is a critical modulator of AVF maturation.
      Specifically, that patients with inflammation will have impaired endothelial function and
      demonstrate less significant remodeling than others.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Vascular surgery clinic
      
Keywords: Chronic Kidney Disease; CKD; ESRD; AV Fistula; Arterio-venous fistula; hemodialysis