bioihbjkbjnl/mcl2 huggingface dataset:
Study to Assess In-home Use of Evolocumab (AMG 145) Using a Prefilled Syringe or a Prefilled Autoinjector/Pen
Condition: Primary Hypercholesterolemia; Mixed Dyslipidemia
MeSH terms: Hypercholesterolemia; Dyslipidemias
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study was to assess users' ability to administer a full dose of
      evolocumab in home-use using either a pre-filled syringe or autoinjector/pen.
    


Intervention name(s): Evolocumab Pre-filled Syringe; Evolocumab AI/pen
Intervention type(s): Biological; Biological
Intervention description(s): Evolocumab subcutaneous injection via a single use, disposable pre-filled syringe.; Evolocumab subcutaneous injection via a handheld mechanical (spring-based) autoinjector/pen.
Other intervention name(s): AMG 145; Repatha; AMG 145; Repatha
Intervention MeSH terms: Evolocumab; Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: LDL-C, triglycerides, high cholesterol
ULTIMATE Study for Weight Loss
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The purpose of this study is to help find out more about how the Primary Obesity Surgery
      Endoluminal (POSE) procedure makes patients feel less hungry and fuller faster, leading to
      weight loss. In this study, USGI Medical wants to see if stomach emptying and
      gastro-intestinal hormone levels change after a POSE procedure with an increased (as compared
      to typical) number of anchors placed.
    

Detailed description: 
      This study will use the USGI Medical Incisionless Operating Platform (IOP) to determine the
      affects of placing more Suture Anchors per patient (as compared to the current practice) in
      Primary Obesity Surgery Endoluminal(POSE). USGI wants to see if placing more anchors
      (particularly in the distal body/antrum region) significantly impacts primary weight loss,
      satiety, and metabolic outcomes.
    

Intervention name(s): g-Cath Suture Anchor Delivery Catheter
Intervention type(s): Device
Intervention description(s): Evaluate changes in emptying, hormones, satiety and weight loss with use of the g-Cath Suture Anchor Delivery Catheter in maximizing g-Cath Suture Anchor placement to as high as 25 anchors.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: POSE
A Study to Evaluate Persistence of Immunity of PCV13 in Healthy Population Aged 2 Months，7 Months-5 Years
Condition: Pneumonia
MeSH terms: Pneumonia
Study type: Interventional
Phase: Phase 4

Summary: 
      The goal of this clinical trial is to learn about persistence of immunity of PCV13 in healthy
      population aged 2 months, 7 months-5 years. The main questions it aims to answer are the
      percentage of subjects reached the IgG level of ≥0.35 µg/mL, GMCs level for IgG antibody, and
      SAEs from one month to 12 months after the last injection.
    


Intervention name(s): PCV13; PCV13; PCV13; PCV13
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): 3 doses of PCV13 intramuscularly at Months 0, 2, and 4 and a booster dose at Month 10; 2 doses of PCV13, and a booster dose; 2 doses of PCV13; single dose of PCV13
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Endoscopic Characterization of Colorectal Neoplasia With the Different Published Classifications: a Prospective Comparative Study
Condition: ENDOSCOPIC CHARACTERIZATION
MeSH terms: Neoplasms
Study type: Observational

Summary: 
      Endoscopic characterization of colorectal lesions has become essential to predict histology
      and choose the best therapeutic strategy. We have created the CONECCT classification grouping
      all the endoscopic criteria already published in a single table. To validate this
      classification, we carried out this comparative study evaluating the endoscopic
      characterization performance of all recognized classifications and CONECCT in terms of
      inter-observer agreement and histological prediction.
    


Intervention name(s): DIGESTIVE ENDOSCOPY
Intervention type(s): Procedure
Intervention description(s): DIGESTIVE ENDOSCOPY
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with colorectal lesions
Changes in Sexual Function Following Bariatric Surgery
Condition: Obesity
Study type: Interventional

Summary: 
      The main purposes of the study are to compare changes in sexual function, changes in sex
      hormones, and changes in body image and marital satisfaction at 12, 24, 36 and 48 months
      postoperatively in two groups: individuals who undergo a bariatric surgical procedure and
      extremely obese individuals with similar obesity-related comorbidities who do not seek
      surgery (treatment comparison group).

      The mechanisms by which extreme obesity affects sexual functioning have received little
      attention. Recent epidemiologic studies suggest that obesity and physical inactivity are
      independently related to the likelihood of developing sexual dysfunction over time. For
      example, men with a BMI greater than 29 kg/m2 have a 30% greater risk of developing erectile
      dysfunction and up to 50 % of ED cases can be attributed to hypertension and cardiovascular
      disease, both commonly associated with obesity. Many treatments for hypertension have also
      been shown to interfere with sexual function.

      Changes in sex hormones with increasing BMI have not received much attention either. Obesity
      has been associated with decreases in testosterone and sex hormone binding globulin for men
      and increases in testosterone and estrogen for women. Several studies have shown improvement
      in sex hormone levels in both men and women following weight loss. Sexual functioning has
      never been assessed in association with weight loss and whether through improvements in body
      image, sex hormones, or obesity related comorbidities, bariatric surgery may have a profound
      effect on sexual functioning.

      Dr. Ray Rosen, the Principal investigator for this sub study, has conducted a previous
      investigation focused on sexual functioning after weight loss in a behavioral weight loss
      program. Specifically, he looked at short and long term sexual function outcomes associated
      with Type-2 diabetes. His previous work in this area has shown that patients are willing to
      participate in studies of sexual function.

      The Psychosocial Changes study assesses sexual function in two ways. Participants first fill
      out a packet of questionnaires covering topics related to depression, quality of life, body
      image, and marital and sexual functioning. They also give a blood sample in order for us to
      assess levels of sex hormones including testosterone, luteinizing hormone, estradiol,
      follicle stimulating hormone, and others.
    


Intervention name(s): Bariatric surgery; lifestyle intervention (behavioral weight loss)
Intervention type(s): Procedure; Behavioral
Intervention description(s): patients receive either gastric bypass or lap-band; participants attend biweekly weight loss counseling group sessions
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Outpatient Foley Cervix Priming
Condition: Outpatient Mechanical Cervix Priming
Study type: Interventional

Summary: 
      The aim was to conduct a non-blinded prospective randomized study at a tertiary hospital.
      Inclusion criteria: term pregnancy with a single fetus in cephalic presentation, Bishop score
      < 6, gestational age > 41 weeks or medical indication for induction of labor.

      Patients will be randomized to outpatient or inpatient cervix priming with Foley catheter.

      The primary outcome will be to compare the variation of Bishop score (difference between
      Bishop score before and after application of Foley catheter) between outpatient and inpatient
      groups. Secondary comparisons include: mode of delivery, Foley catheter
      application-to-delivery time, inpatient time, sequential use of prostaglandins, infection and
      maternal pain.
    


Intervention name(s): Outpatient Foley cervix priming
Intervention type(s): Other
Intervention description(s): Outpatient setting for cervix priming with Foley catheter
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Prediction Frozen Shoulder Validation
Condition: Frozen Shoulder
MeSH terms: Bursitis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Background: Few studies have examined the predictors of the clinical course of subjects with
      frozen shoulder syndrome or explained the persistence of symptoms after appropriate therapy.
      Altered shoulder kinematics may predispose subjects to subacromial impingement, rotator cuff
      tendonitis, altered shoulder joint forces, and possible degenerative changes. Subsequently, a
      more difficult and chronic course of frozen shoulder syndrome may develop.

      Objective: The purposes of this study are: (1) to develop a prediction method for determining
      altered shoulder kinematics and associated muscular activities which are associated with the
      chronicity of frozen shoulder dysfunction, and (2) to validate this prediction method and
      analyze the impact of the method on clinical behavior.

      Design: For the first year, a prospective study will be conducted to develop a prediction
      method that will identify impaired shoulder kinematics associated with the degree of
      symptom-related functional disability in patients with frozen shoulder syndrome. For the
      second and third years, validation of the proposed prediction method will determine whether
      altered shoulder kinematics and associated muscular activities subject to intervention meet
      the prediction criteria and demonstrate improvement in their follow-up, which will be shown
      to improve decision making in clinical practice.
    


Intervention name(s): a standardized physical therapy program; EMSMTA
Intervention type(s): Other; Other
Intervention description(s): passive mobilization, stretching techniques, physical modalities (i.e., ultrasound, shortwave diathermy, and/or electrotherapy), and active exercises; end-range mobilization/scapular mobilization treatment approach
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Effect of Switching From Cigarette Smoking to IQOS on Exercise Capacity
Condition: Smoking; Exercise Capacity
Study type: Interventional

Summary: 
      This exploratory study is part of the global clinical assessment program of IQOS. It was
      designed to provide scientific evidence to further substantiate the reduced risk potential of
      using a heated tobacco product (the Tobacco Heating System [THS] marketed as IQOS) as
      compared to smoking cigarettes. The main goals of this exploratory study were to assess
      whether switching from cigarette smoking to using IQOS would influence 1) maximum oxygen
      uptake during incremental exercise (VO2max) and exercise capacity, 2) ability to perform
      exercise training and thereby influence 3) VO2max after 12 weeks of exercise training, 4)
      physiological parameters and biological health markers, and finally 5) physical activity
      levels in daily life.
    

Detailed description: 
      This exploratory study, with healthy adult smokers, was designed without product use
      restrictions (ad libitum product use) in order to replicate as closely as possible "real
      life" conditions. Subjects randomized to the cigarette and IQOS arms were asked to buy their
      own cigarettes or HeatSticks, respectively. Subjects randomized to the smoking abstinence
      (SA) arm were instructed to stay smoking abstinent until the end of the study. Subjects in
      the SA arm received smoking abstinence support and, in order to prevent relapse to cigarette
      smoking during the training program, were also allowed to use nicotine replacement therapy.

      Mobile health technology was used in the study to explore the impact on switching from
      smoking to using IQOS on physical activity in daily real-world living conditions. The
      wearable enabled non-invasive recording of physical activity in an objective manner
      throughout the study. However, results collected from this device will be reported
      separately.

      It should be noted that some study outcomes were reported graphically, rather than
      numerically. Consequently, these outcomes have not been included in this results disclosure.
    

Intervention name(s): IQOS + Exercise Training Program; IQOS without Exercise Training Program; Cigarette Smoking + Exercise Training Program; Smoking Abstinence + Exercise Training Program
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Switch to IQOS use + participation in a training program; Switch to IQOS use only, without participation in a training program; Continue to smoke cigarettes + participation in a training program; Switch to smoking abstinence + participation in a training program
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: IQOS; Heated Tobacco
Paracervical Block in First Trimester Surgical Abortions
Condition: Pain; Surgical Abortion
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The investigators primary objective is to study the analgesic effects of combined ketorolac
      and lidocaine in a paracervical block compared to preoperative ibuprofen followed by
      intra-operative paracervical block with lidocaine alone on women undergoing first trimester
      surgical abortions. The investigators hypothesize that women who receive a paracervical block
      of combined ketorolac and lidocaine will experience less pain during the procedure based on a
      visual analog scale (VAS) compared to those who receive preoperative ibuprofen and a
      paracervical block with lidocaine alone.

      This randomized, multi-site, placebo-controlled clinical trial will investigate the
      difference in perceived pain from first trimester surgical abortions using a paracervical
      block of combined ketorolac and lidocaine compared to preoperative ibuprofen and paracervical
      block with lidocaine alone. A total of fifty women who are seeking elective surgical
      abortions of intrauterine pregnancies less than 11 0/7 weeks' gestation will be recruited
      from Johns Hopkins Bayview Medical Center, Planned Parenthood of Maryland in Baltimore,
      Maryland and Planned Parenthood Columbia-Willamette in Portland, Oregon. Pain before, during,
      and after surgical abortion will be measured using a 100-mm VAS.

      The primary outcome of interest is the mean difference in pain level from preoperative
      baseline to time after cervical dilation comparing the treatment groups. If the investigators
      see greater pain reduction associated with the paracervical block of lidocaine and ketorolac,
      adoption of this regimen may improve pain management during first trimester surgical
      abortions. If combined ketorolac and lidocaine when administered as a paracervical block is
      proven to be efficacious, the need for additional analgesia in first trimester surgical
      abortions can be minimized.
    


Intervention name(s): lidocaine; ketorolac and lidocaine
Intervention type(s): Drug; Drug
Intervention description(s): paracervical block with lidocaine; paracervical block with ketorolac and lidocaine
Intervention MeSH terms: Ketorolac; Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pain associated with first trimester surgical abortion
LAGB Versus VBG: 7-Year Results
Condition: Morbid Obesity; Bariatric Surgery; Vertical Banded Gastroplasty; Laparoscopic Adjustable Gastric Banding; Long Term Results
MeSH terms: Obesity, Morbid
Study type: Interventional

Summary: 
      The study aims to investigate the long term results of a randomized clinical single-centre
      trial comparing two standard operative techniques in bariatric surgery; laparoscopic
      adjustable gastric banding and vertical banded gastroplasty.
    

Detailed description: 
      One hundred morbidly obese patients were included in the study. Randomization between the two
      operative techniques was performed using a computer model. Fifty patients were included in
      both groups. Weight loss, obesity-related comorbidity, long term complications, re-operations
      and conversions were all prospectively investigated for a mean period of 84 months.
    

Intervention name(s): Laparoscopic adjustable gastric banding; vertical banded gastroplasty
Intervention type(s): Procedure; Procedure
Intervention description(s): Laparoscopic adjustable gastric banding; vertical banded gastroplasty
Other intervention name(s): LAGB, AGB, LB, lap-band, SAGB; VBG, Mason, gastroplasty
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: VBG; LAGB; long term results; Weight loss; Complications; Reoperations; Conversion
"In Vivo" Comparison in Human Carotid Atherosclerosis: Plaque Neovascularization
Condition: Carotid Artery Disease; Plaque Neovascularization
MeSH terms: Carotid Artery Diseases; Atherosclerosis; Neovascularization, Pathologic
Study type: Interventional

Summary: 
      Atherosclerosis may initiate early in life and takes years to progress. This contrasts to the
      abrupt coronary or cerebrovascular events occurring following the transition from a stable to
      an unstable atherosclerotic plaque. The causes of this discontinuity of the disease are
      complex and probably multiple. There is increasing evidence that, besides inflammation,
      neovascularisation of atherosclerotic plaques and intra-plaque hemorrhages play an important
      role in plaque instability ending-up frequently in acute thrombotic occlusion or distal
      embolisation of athero-thrombotic material associated with heart attack or stroke.
      Contrast-enhanced Ultrasound, is a bed-side non-invasive technique, which allows to enhance
      microvascular structures and to visualize the adventitia and intraplaque vascularization.
      Dynamic contrast-enhanced plaque MRI (DCE-MRI) which has also been evaluated for in vivo
      detection and quantification of plaque neovascularity. Together with the presence of a large
      lipid-rich core, thin fibrous cap, positive remodeling and active inflammatory infiltrate,
      plaque neovascularisation is considered a valid marker of high-risk (or vulnerable) plaque as
      demonstrated in histopathological studies using microvessel density.

      Aim of the study is to assess and validate the value of contrast enhanced ultrasound (CEUS),
      a bed-side technique, in detecting plaque neovascularisation and compare it with the
      quantitative assessment by DCE-MRI in carotis atherosclerosis.

      A group of 30 patients with asymptomatic carotid atherosclerosis (> 50% stenosis on Doppler
      ultrasound) will undergo Carotid Duplex ultrasounds and CEUS. High-resolution plaque MRI and
      DCE-MRI will be performed in the same patients and will be analyzed by two separate operators
      blinded to the results of the CEUS in order to detect the efficacy of CEUS when compared with
      in vivo DCE-MRI, as the standard of reference.
    


Intervention name(s): Contrast enhanced ultrasound of the carotid plaque; Dynamic contrast-enhanced carotid plaque MRI
Intervention type(s): Other; Other
Intervention description(s): visual grading of neovessel; quantitative analysis of gadolinium enchantment in a region of interest
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Primary Imiquimod Treatment Versus Surgery for Vulvar Intraepithelial Neoplasia
Condition: Vulvar Intraepithelial Neoplasia
MeSH terms: Neoplasms; Carcinoma in Situ
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the efficacy (defined as complete clinical response at 6 months) of imiquimod vs.
      standard treatment (surgery) for vulvar intraepithelial neoplasia (VIN).
    


Intervention name(s): Imiquimod; Surgery
Intervention type(s): Drug; Procedure
Other intervention name(s): Aldara; Excision; Ablation
Intervention MeSH terms: Imiquimod
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: VIN; Imiquimod; Surgery; HPV; Patient satisfaction
Allopurinol in Schizophrenia: A Randomized Trial Administering Allopurinol vs Placebo as add-on Antipsychotics in Patients With Schizophrenia
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of the study is to evaluate the efficacy of allopurinol, compared to placebo,
      as add-on to anti-psychotics in the treatment of patients with schizophrenia.
    

Detailed description: 
      An emerging body of evidence supports a purinergic hypothesis for schizophrenia. Adenosine
      agonists have been shown to have properties similar to those of dopamine antagonists and
      there is a well characterized antagonistic interaction between adenosine and dopamine
      receptors in the ventral striatum1. Increased adenosinergic transmission has been
      demonstrated to reduce the affinity of dopamine agonists for dopamine receptors. It has been
      theorized that adenosine may exert some of its antipsychotic effects through modulation of
      glutamatergic transmission.

      Three double-blind, randomized, placebo-controlled trials have showed statistically
      significant greater improvements in PANSS scores in the allopurinol groups vs. placebo
      groups. These empiric data, together with the theoretical and basic science background cited,
      provide the impetus for this proposed study.
    

Intervention name(s): Allopurinol
Intervention type(s): Drug
Intervention description(s): Allopurinol 1 capsule 300 mg, or placebo, bid (twice a day) for 42 days.
Other intervention name(s): Alloril, Zylol, Zyloric
Intervention MeSH terms: Allopurinol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Schizophrenia; Allopurinol; Add-on-treatment