bioihbjkbjnl/mcl2 huggingface dataset:
SPIRIT 1: Efficacy and Safety Study of Relugolix in Women With Endometriosis-Associated Pain
Condition: Endometriosis Related Pain
MeSH terms: Endometriosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the benefit and safety of relugolix 40 milligrams
      (mg) once daily, co-administered with low-dose estradiol (E2) and norethindrone acetate
      (NETA) compared with placebo for 24 weeks, on dysmenorrhea and on nonmenstrual pelvic pain.
    

Detailed description: 
      This study is an international phase 3 randomized, double-blind, placebo-controlled efficacy
      and safety study to evaluate 24 weeks of oral, once-daily relugolix (40 mg) co-administered
      with either 12 or 24 weeks of low-dose E2 (1.0 mg) and NETA (0.5 mg), compared with placebo.

      Approximately 600 women with endometriosis-associated pain will be enrolled and randomized
      1:1:1 to Group A - relugolix plus low-dose hormonal add-back therapy, Group B - relugolix
      monotherapy for 12 weeks followed by co-administration with low-dose hormonal add-back
      therapy, or Group C - placebo (N = 200 per group).

      Eligible participants were randomized on Baseline Day 1 to Treatment Group A, B, or C, in the
      double-blind period.

      Eligible participants, including those randomized to placebo, were offered the opportunity to
      enroll in an 80-week open-label extension study where participants received relugolix
      co-administered with low-dose E2 and NETA. Participants who did not enroll into the extension
      study had a Follow-Up visit approximately 30 days after the participant's last dose of study
      drug.
    

Intervention name(s): Relugolix; Estradiol/norethindrone acetate; Estradiol/norethindrone acetate placebo; Relugolix placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Relugolix 40-mg tablet administered orally once daily.; Capsule containing co-formulated tablet of E2 (1.0 mg)/NETA (0.5 mg) administered orally once daily.; E2 (0 mg)/NETA (0 mg) placebo capsule administered orally once daily and designed to match the E2/NETA capsule in size, shape, color, and odor.; Relugolix (0 mg) placebo tablet administered orally once daily and manufactured to match the relugolix tablet in size, shape, color, and odor.
Other intervention name(s): TAK-385; MVT-601; E2/NETA
Intervention MeSH terms: Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Norethindrone; Norethindrone Acetate; Estradiol; Polyestradiol phosphate; Relugolix
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Endometriosis; Pain; Dysmenorrhea
A Single and Multiple Ascending and Food Effect Study of RP7214, a DHODH Inhibitor in Healthy Adult Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, double-blind study to evaluate the safety, tolerability and PK of
      single and multiple ascending oral doses of RP7214. The relative bioavailability in fed and
      fasting conditions will also be evaluated for RP7214. The study comprises three parts; Part
      1: Single ascending dose, Part 2: Multiple ascending dose and Part 3: Food effect.
    

Detailed description: 
      There are three escalating cohorts in SAD part and two escalating cohorts in MAD part. In
      each cohort, six eligible healthy volunteers will be randomized to receive either RP7214 or
      placebo in 2:1 ratio. Within each cohort, two sentinel subjects (RP7214 and Placebo) will be
      dosed first for assessment of safety and tolerability. The safety data of at least 48 hrs
      will be reviewed to confirm safety of sentinel subjects after which the remaining four
      subjects will be dosed. Food effect study is a randomized, 2-treatment, 2-period, 2-sequence,
      crossover study in 12 HVs.
    

Intervention name(s): RP7214; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive single and multiple ascending doses of RP7214; Participants will receive single and multiple ascending doses of matching placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: DHODH
Echocardiographic Evaluation of the Change on Pulmonary Blood Flow and Cardiac Function Induced by Capnothorax During One Lung Ventilation
Condition: Mediastinal Tumors
MeSH terms: Mediastinal Neoplasms
Study type: Interventional

Summary: 
      Video-assisted thoracoscopic extended thymectomy (VATET) is a minimally-invasive method for
      excision of mediastinal mass instead of open thymectomy. The iatrogenic capnothorax with
      one-lung ventilation during VATET may cause hemodynamic instability due to the compression of
      intrathoracic structures. The purpose of this study is to evaluate the effects of capnothorax
      on the pulmonary blood flow and cardiac function during the VATET by using the
      transesophageal echocardiography.
    

Detailed description: 
      Video-assisted thoracoscopic extended thymectomy (VATET) is a minimally-invasive method for
      excision of mediastinal mass instead of open thymectomy. The iatrogenic capnothorax with
      one-lung ventilation during VATET may cause hemodynamic instability due to the compression of
      intrathoracic structures. The purpose of this study is to evaluate the effects of capnothorax
      on the pulmonary blood flow and cardiac function during the VATET by using the
      transesophageal echocardiography
    

Intervention name(s): capnothorax
Intervention type(s): Procedure
Intervention description(s): After patient positioning, the capnothorax will be created by insufflation of carbon dioxide in patients undergoing video-assisted thoracoscopic extended thymectomy.
Other intervention name(s): VATET, capnothorax, TEE
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: mediastinal mass, one-lung ventilation, capnothorax, transesophageal echocardiography
A Study To Explore The Effect On Inflammatory Markers After Nasal Allergen Challenge In Subjects With Seasonal Allergic Rhinitis And The Effect Of A Single Dose Of Ibuprofen Or Fluticasone Propionate On The Allergen Response.
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 1

Summary: 
      After a nasal allergen challenge it should be possible to measure markers of inflammation
      that may be useful to assess the properties of future drugs. If these markers are
      reproducible and impacted by the study drugs they could be useful for future drug
      development.
    


Intervention name(s): Ibuprofen; Fluticasone propionate; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 800 mg oral; 200 mcg intra-nasal; Placebo
Intervention MeSH terms: Fluticasone; Xhance; Ibuprofen
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Allergic Rhinitis Nasal Allergen Challenge Inflammatory Markers
Comparison of 1 vs 3 Sets of Resistance Training on Muscular Hypertrophy
Condition: Obesity
Study type: Interventional

Summary: 
      This study is designed to investigate the effects of two levels of resistance weight training
      on body composition, energy expenditure, and energy intake in men and women. The weight
      training will take about one hour to complete. Participants will perform the training 3 days
      per week for 9 months in a private exercise room equipped with state of the art equipment and
      a personal trainer to help guide you through the exercises.

      The project lasts 21 months total with one follow-up visit 1-year from your last training
      date. You will be required to stay in the Lawrence area and train 3 day/week over the summer
      & holidays.
    

Detailed description: 
      We propose to conduct a randomized controlled efficacy trial (RT-1 set vs. RT-3 sets vs. non
      exercise control) to evaluate the potential for a longer intervention (9 months RT with body
      composition assessments 1 yr post RT completion) with a higher volume of RT (3 sets) to
      enhance the effects on body composition and energy expenditure observed in the pilot, and to
      determine the impact of the 2 levels of RT on free-living energy balance (expenditure by
      doubly labeled water and intake by digital photography and 24-hr recalls). This investigation
      will be conducted in a sample of healthy, normal and overweight, sedentary, young adult men
      and women; a group at high risk for development of overweight and obesity. The specific aims
      of this project are to determine the impact of the volume (1 vs. 3 sets) of a progressive RT
      protocol for inducing muscular hypertrophy, as recommended by the American College of Sports
      Medicine, on body weight and body composition (fat mass, fat-free mass (FFM), % body fat) and
      energy balance. Our results will provide information relative to the minimum volume of RT
      that may be associated with body weight/fat gain which may inform the development of
      guidelines for RT to prevent weight gain or to alter body composition. If RT has a favorable
      impact on energy balance and body composition, it may provide an attractive alternative to
      aerobic exercise for weight management for busy young adults, as RT requires minimal time,
      and no need to change clothes or shower (i.e. minimal or no sweating).
    

Intervention name(s): Amount of resistance offered in training
Intervention type(s): Other
Intervention description(s): to determine the impact of the volume (1 vs. 3 sets) of a progressive resistance training protocol for inducing muscular hypertrophy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: resistance and weight loss training
A Pilot Study Simulating Multifocal Intraocular Lenses in Healthy Subjects
Condition: Lenses, Intraocular; Contrast Sensitivity; Visual Acuity
MeSH terms: Hypersensitivity
Study type: Observational

Summary: 
      Age related cataracts are responsible for about 51 percent of blindness worldwide and
      according to the WHO affect about 20 million people, according to the WH . As cataract
      surgery is firstline treatment in the western world, there is a constant attempt to improve
      artificial intraocular lenes (IOL).

      As for this study, the investigators seek to compare four different IOL designs in in a
      psychophysiological setting, allowing to assess the impact of these IOLs on vision and
      psychological processing of visual information.

      As these IOLs also have downsides, such as reduced light intensity or image alterations, the
      subjective preference and overall impression shall be investigated. The healthy subjects look
      through a stable spectacle frame mounted onto a table, which enables the investigator to
      insert the different IOLs. This would allow subjective testing of IOLs before surgery.
    


Intervention name(s): Cyclopentolatehydrochloride
Intervention type(s): Drug
Intervention description(s): Cyclopentolatehydrochloride 0.5% (Thilo, Alcon, Vienna), dose: 1 drop for study eye
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        young healthy subjects
Volume Restoration of the Aging Midface With Sculptra Aesthetic
Condition: Problem of Aging
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to examine the effect of Sculptra Aesthetic on the cosmetic
      rejuvenation of the midface complex. The investigators plan to both qualitatively determine
      the restoration of midface architecture as well as quantitatively document the change in
      midface volume by employing three-dimensional (3D) surface imaging which critically analyzes
      volumetric tissue changes. Our hypothesis is that patients who receive Sculptra Aesthetic
      injections will experience significant improvement in facial midface volume restoration.

        -  Measure the midfacial volumetric correction from Sculptra Aesthetic treatment, using
           three-dimensional digital surface imaging

        -  Determine the mean change from baseline in facial contour via quantitative volumetric
           measurements

        -  Correlate volumetric correction with clinical improvement as measured by the Facial
           Lipoatrophy Panel grading system

        -  Correlate the mean volumetric change in midfacial treatment area with the amount of
           product used

        -  Obtain photographs pre- and post-treatment for the purpose of providing a subject visual
           aid during the course of treatment

        -  Collect safety data
    


Intervention name(s): injectable poly-L-lactic acid
Intervention type(s): Drug
Intervention description(s): Each patient will receive up to 1 vial of Sculptra Aesthetic total to both midface complexes at each of 3 treatment sessions, spaced 6 weeks apart.
Other intervention name(s): Sculptra Aesthetic; Sculptra; Poly-L-lactic acid
Intervention MeSH terms: Mannitol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: midface volume loss; aging of midface; sculptra; sculptra aesthetic; poly-L-lactic acid
Evaluate the Safety and Explore Efficacy of Umbilical Cord Mesenchymal Stem Cells in Acute Myocardial Infarction
Condition: Acute Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a first-in-human assessment of safety of using UCMSC in patients with AMI via a
      combination of IC and IV stem cell administration. The novelty of the current UMSC01
      treatment study is the dual route of administration. Since dual administration of UCMSC via
      IC and IV had never been conducted in humans, there may be unknown risks to humans not
      predicted from the preclinical studies. However, the risk to patients in this trial will be
      minimized by rigorous adherence to the eligibility criteria, use of appropriate dose and
      concentration of stem cells, standardized techniques of stem cell infusion, and intensive
      patient monitoring during and after stem cell infusion.
    

Detailed description: 
      Cardiovascular disease is the leading cause of death in the developed world, with global
      deaths due to coronary artery disease estimated to increase from 7.3 million in 2008 to 25
      million by 2020 WHO, 2011.

      The leading symptom that initiates the diagnostic and therapeutic cascade in patients with
      suspected acute coronary syndromes (ACS) is chest pain.

      Most patients will ultimately develop an ST elevation myocardial infarction (STEMI). The
      mainstay of treatment in these patients is immediate reperfusion by primary angioplasty or
      fibrinolytic therapy. Basically, STEMI comprises approximately 25% to 40% of myocardial
      infarction (MI) presentations. Acute STEMI is a major cause of morbidity, mortality, and
      disability.

      This product is a new cell therapy product for treating AMI and produced by Ever Supreme Bio
      Technology Co., Ltd in Taiwan. For animal studies, UMSC01 has been demonstrated its
      effectiveness for AMI and stroke. The rats with coronary artery ligation receiving
      intravenous injection of UMSC01 showed significantly improved cardiac function.
    

Intervention name(s): Allogeneic umbilical cord mesenchymal stem cells
Intervention type(s): Biological
Intervention description(s): UMSC01 cells will be one single IC infusion followed by one single IV infusion with 12 months of follow up after treatment.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Comparative Study On The Effect Of Propolis And Dentine Bonding Agent In Treating Dentine Hypersensitivity
Condition: Dentine Hypersensitivity
MeSH terms: Dentin Sensitivity; Hypersensitivity
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Background:

      Dentine hypersensitivity (DH) causes considerable pain and discomfort to an individual due to
      number of stimuli on exposed dentine. Different kinds of treatment strategies are used in the
      resolution of dentine hypersensitivity including the use of propolis and dentine bonding
      agent. No study had compared the efficacy of propolis and dentine bonding agent.

      Objective:

      The objective of the study was to find out whether there is a difference in the efficacy of
      Propolis and seventh generation dentine bonding agent in reducing the dentine
      hypersensitivity. Comparison within the groups and pairwise comparisons were also recorded in
      reducing dentine hypersensitivity.

      Methods:

      In this six month In- Vivo single blinded randomized clinical study, a total number of 52
      patients with complain of dentine hypersensitivity were selected in two groups after taking
      informed consent. Group A and B received 30% ethanolic extract of propolis and dentine
      bonding agents respectively by a trained operator. Recordings of dentine hypersensitivity
      were obtained at Day 0, before and after the application of experimental agents, and also on
      Day 7, 15 and 30 by the principal investigator. Response was measured by Visual Analog Scale
      and Schiff Cold Air Sensitivity Scale. Statistical Package for the Social Sciences (SPSS)
      version 20 was used to analyze the data with level of significance set at p < 0.05. Friedman
      test was applied to see the comparison within groups and Wilcoxon Signed Rank test was used
      for Pairwise comparison. Mann Whitney U-Test was applied for comparison between groups.
    


Intervention name(s): Dentin-Bonding Agents; Propolis
Intervention type(s): Drug; Drug
Intervention description(s): 3M ESPE Scotchbond™ Universal Adhesive systems is a seventh generation single-bottled one-step self-etch adhesive system.; Propolis was obtained from Margalla hills, Islamabad by NARC (National Agriculture Research Council, Islamabad). Plant source origin is Acacia modesta and Apis mellifera bees collect it. The 30% ethanolic extract of propolis from raw propolis was obtained in Pakistan Council of Scientific & Industrial Research (PCSIR) by dissolving the propolis in 95% ethanol and straining out the precipitate
Intervention MeSH terms: Propolis
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Efficacy and Safety of Etelcalcetide (AMG 416) in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease on Hemodialysis
Condition: Hyperparathyroidism, Secondary
MeSH terms: Neoplasm Metastasis; Kidney Diseases; Renal Insufficiency, Chronic; Hyperparathyroidism; Hyperparathyroidism, Secondary
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is designed to assess the efficacy and safety of etelcalcetide compared with
      placebo in the treatment of SHPT in patients with chronic kidney disease (CKD) receiving
      hemodialysis.
    


Intervention name(s): Etelcalcetide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered intravenously three times per week. The starting dose was 5 mg. The dose may have been increased at 4-week intervals by 2.5 mg or 5 mg on the basis of the predialysis parathyroid hormone and corrected calcium concentrations obtained in the prior week. The minimum dose was 2.5 mg and the maximum dose was 15 mg.; Administered intravenously (IV) three times per week.
Other intervention name(s): AMG 416; KAI-4169
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Secondary Hyperparathyroidism (SHPT), chronic kidney disease (CKD), hemodialysis, parathyroid hormone (PTH), hypocalcemia, bone and mineral metabolism
Suspected Deficient Activation of Vitamin D in Patients With Secondary Hyperparathyroidism
Condition: Secondary Hyperparathyroidism
MeSH terms: Neoplasm Metastasis; Hyperparathyroidism; Hyperparathyroidism, Secondary
Study type: Interventional

Summary: 
      The purpose of this study is to determine if a reduction in the enzyme 1-hydroxylase, which
      activates Vitamin D, is the cause of overactivity of the parathyroid glands (called secondary
      hyperparathyroidism - normal blood calcium and elevated parathyroid hormone) in a selected
      group of young patients with normal kidney function.
    

Detailed description: 
      Vitamin D, an essential nutrient, is produced by the skin after sunlight shines on it.
      Vitamin D must then be activated by both the liver and the kidneys to perform its function of
      maintaining strong bones and helping to prevent heart disease, infection, diabetes and
      cancer. Reduced kidney activation of Vitamin D occurs with advanced age and with all kidney
      diseases. We have identified a small group of patients who appear to have reduced ability of
      the kidneys to activate vitamin D, even though they are young and do not have chronic kidney
      disease. In these patients, we are comparing the ability of their kidneys to activate Vitamin
      D to that of healthy controls. To stimulate the kidneys to activate Vitamin D, we are giving
      parathyroid hormone intravenously over 8 hours and collecting blood and urine at baseline, 4
      and 8 hours. This type of parathyroid infusion does not cause side effects. The gene that
      controls this activation is also being studied (by a simple blood test) to look for
      abnormalities. We are now actively recruiting healthy controls for this study.
    

Intervention name(s): Teriparatide
Intervention type(s): Drug
Intervention description(s): Teriparatide will be given by continuous intravenous infusion at a rate of 12 pmol/kg/hr for 8 hours to both "patients" and "controls"
Other intervention name(s): Forteo
Intervention MeSH terms: Teriparatide
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: hyperparathyroidism; parathyroid; vitamin D; vitamin D deficiency
24-hr Intraocular Pressure Control With Dorzolamide/Timolol vs the Brimonidine/Timolol Fixed Combination
Condition: Glaucoma
MeSH terms: Glaucoma
Study type: Interventional
Phase: Phase 4

Summary: 
      The proposed study will compare for the first time the quality of 24-hour IOP control with
      Brimonidine/Timolol fixed combination (BTFC) versus Dorzolamide/Timolol fixed combination
      (DTFC) after a run-in period of 2 months with timolol. This crossover comparison may
      determine the real efficacy of the two fixed combinations and the design of the proposed
      study may explain for the first time why the 24-hour IOP reduction provided by BTFC is less
      than might be anticipated.
    


Intervention name(s): treatment with dorzolamide/timolol; treatment with brimonidine/timolol
Intervention type(s): Drug; Drug
Intervention description(s): 24-hour IOP control with the two fixed combinations; 24-hour pressure control with brimonidine/timolol
Intervention MeSH terms: Timolol; Brimonidine Tartrate; Dorzolamide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: 24-hour IOP control; primary open-angle glaucoma; brimonidine/timolol; dorzolamide/timolol