bioihbjkbjnl/mcl2 huggingface dataset:
Clinical Study of SU011248 in Subjects With High Risk Prostate Cancer Who Have Elected to Undergo Radical Prostatectomy
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      Prostate cancer is prevalent in the United States, with approximately 230,110 new cases and
      29,900 deaths in 2004. Approximately 30% of new cases will be clinical stage T3 when they are
      diagnosed. This is a stage in which there is high probability that the cancer has spread
      beyond the prostate gland itself, making it much more difficult to treat. In these cases,
      when surgery is done by itself and the prostate is removed, it is still very likely that some
      cancer that has spread beyond the prostate remains and will get worse. Radiation applied to
      the prostate also does not work well on tumors that have spread beyond the prostate. Even
      surgery and radiation combined have not eliminated the problems caused by prostate cancer
      that has spread into the tissue outside the prostate itself.

      New treatments are needed to deal with prostate cancer at this more serious stage. Study
      doctors believe that it might be possible to shrink the prostate cancer using a new drug
      called SUO11248 or Sunitinib. After the patients take the drug, study doctors believe the
      cancer will shrink back to within the prostate, and they can then surgically remove the
      prostate and all the cancer. Patients on this study also will be given increasing doses of
      Sunitinib to find out how much of the drug can be given safely.
    


Intervention name(s): SU011248; SU011248; SU011248; SU011248; SU011248
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 5 Subjects will receive 50.0 mg/d of the study drug for 2 weeks.; 5 Subjects will receive 50.0 mg/d of the study drug for 4 weeks.; 5 Subjects will receive 50.0 mg/d of the study drug for 1 week.; 5 Subjects will receive 37.5 mg/d of the study drug for 1 week.; 5 Subjects will receive 37.5 mg/d of the study drug for 2 weeks.
Intervention MeSH terms: Sunitinib
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Prostatectomy
Minocycline in Primary Sclerosing Cholangitis (PSC)
Condition: Primary Sclerosing Cholangitis
MeSH terms: Cholangitis; Cholangitis, Sclerosing
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to see how safe and effective minocycline is in the treatment of
      Primary Sclerosing Cholangitis (PSC).
    

Detailed description: 
      The purpose of the study is to determine the safety profile of minocycline in patients with
      PSC and to compare the effects of minocycline on the baseline values of the following
      parameters: symptoms of pruritus and fatigue, liver biochemistries, Mayo Risk Score, the
      development of clinical progression and complications of liver disease.
    

Intervention name(s): Minocycline
Intervention type(s): Drug
Intervention description(s): Minocycline 100 mg capsules twice a day before breakfast and before dinner.
Intervention MeSH terms: Minocycline
Intervention model: Single Group Assignment
Primary purpose: Treatment
Keywords: PSC
Repository Corticotropin Injection To Treat Rheumatoid Arthritis Patients Who Have Failed Three Biologic Therapies.
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 4

Summary: 
      It is hypothesized that repository corticotropin injection in combination with other biologic
      agents will be able to provide relief of both rheumatoid arthritis and acute exacerbations of
      rheumatoid arthritis for patients with disease that had inadequately responded to biologics
      previously.
    

Detailed description: 
      Although there are many types of treatment for rheumatoid arthritis (RA) currently available,
      some patients have disease that is refractory to treatment and cannot achieve remission. The
      objective of this study is to assess the efficacy and safety of subcutaneous injections of
      repository corticotropin as an adjunct therapy in patients with active RA who have had an
      inadequate response to at least two biologic agents as well as a third agent they are
      currently receiving.
    

Intervention name(s): Repository corticotropin injection
Intervention type(s): Drug
Intervention description(s): An adrenocorticotropic hormone (ACTH) analogue that stimulates the adrenal cortex to secrete cortisol, corticosterone, aldosterone, and a number of weakly androgenic substances
Other intervention name(s): H. P. Acthar Gel
Intervention MeSH terms: Adrenocorticotropic Hormone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Rheumatoid arthritis; Joint pain; Repository corticotropin injection
ABX Plus Cisplatin Versus Gemcitabine Plus Cisplatin in Triple Negative Breast Cancer (TNBC)
Condition: Breast Cancer
MeSH terms: Breast Neoplasms; Triple Negative Breast Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      ABX Plus Cisplatin Versus Gemcitabine Plus Cisplatin in Triple Negative Breast Cancer (TNBC)
    

Detailed description: 
      A Phase III, Multicenter, Randomized Study of ABX Plus Cisplatin (AP) Versus Gemcitabine Plus
      Cisplatin (GP) as First-Line Treatment in Patients With Advanced Triple-Negative Breast
      Cancer
    

Intervention name(s): ABX, cisplatin; Gemcitabine, Cisplatin
Intervention type(s): Drug; Drug
Intervention description(s): ABX 125 mg/m2, IV drip 30 minutes, D1, D8 Cisplatin 75 mg/m2, IV drip 120 minutes, D1; Gemcitabine 1250 mg/m2, IV drip 30 minutes, D1, D8 Cisplatin 75 mg/m2, IV drip 120 minutes, D1
Other intervention name(s): experimental arm; control arm
Intervention MeSH terms: Cisplatin; Gemcitabine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: triple negative breast cancer; fine line chemotherapy
Clinical Efficacy of Soft Tissue Trimmer in Cases of Gingival Hyperplasia.
Condition: Pain, Postoperative; Wound Heal; Gingival Hyperplasia
MeSH terms: Gingival Hyperplasia; Hyperplasia; Pain, Postoperative
Study type: Interventional

Summary: 
      Postoperative pain and wound healing are compared after using conventional scalpel technique
      in comparison with the intervention which is using Soft tissue Trimmer for cases of gingival
      hyperplasia.
    

Detailed description: 
      In the control group:

        1. Following the local anaesthetic administration, A reverse bevel gingivectomy will be
           performed with a #15c scalpel.

        2. The borderline of gingiva will be determined via the use of a pointer dental tweezers,
           and excessive gingival tissue will then be removed with Gracey curettes

        3. No periodontal packs to be applied to ensure accurate evaluations of follow-up pain and
           wound healing

      In the intervention group:

        1. Following the local anaesthetics administration for the Soft tissue trimmer(STT)
           gingivectomies, Soft tissue trimmer will be used with 400-rpm rotary systems and with no
           serum irrigation, per the manufacturer's recommendation.

        2. Gingivoplasties will be performed with the same Soft tissue trimmer to easily provide a
           knife-edge appearance.

        3. No periodontal packs will be applied to ensure accurate evaluations of follow-up pain
           and wound healing.
    

Intervention name(s): Excision of gingival hyperplasia using "Soft tissue trimmer ".; Excision of gingival hyperplasia using the conventional scalpel technique
Intervention type(s): Procedure; Procedure
Intervention description(s): Gingivoplasties and removal of excess gingival tissues using Soft tissue trimmer.; Excision of gingival hyperplasia in gingivoplasties using the conventional technique reverse bevel using 15c blade.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Add On Treatment for Cognitive Deficits in Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia; Cognition Disorders; Cognitive Dysfunction
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will look at the impact of dosing as well as ongoing treatment with an
      investigation medication identified as PF-03654746, on cognitive and physiologic indicators
      of brain function. Data from this study will assist with the evaluation of the utility of
      functional magnetic resonance imaging, arterial spin labeling (ASL), and electrophysiologic
      measures in the detection of early signals of the effectiveness of medications developed to
      target cognitive impairment in schizophrenia. Safety and tolerability of PF-03654746 in this
      population will be also be evaluated.
    


Intervention name(s): PF 03654746; Placebo
Intervention type(s): Drug; Other
Intervention description(s): All participants will receive 3 weeks of PF-03654746 and 3 weeks of placebo. PF-03654746 and placebo will be administered in a flexible titration regimen, beginning with 0.5 mg/d. If 0.5 mg/d is well tolerated, the dose will be increased to 1.0 mg/d after 5 days. If 1.0 mg/d is not well tolerated, the dose will be decreased to 0.5 mg/d, with the goal of achieving a stable dose of PF-03654746 within the first two weeks of dosing and avoiding further dose changes during the final week of dosing.; Placebo will be used as a comparator to the active arm.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Schizophrenia; Cognitive Impairment; Electrophysiology; H3 receptor antagonist
Mathematical Model for the Human Menstrual Cycle, Endocrinological Diseases and Fertility Treatment-PAEON
Condition: Polycystic Ovary Syndrome; Endometriosis; Hyperprolactinemia
MeSH terms: Polycystic Ovary Syndrome; Hyperprolactinemia; Endometriosis
Study type: Observational

Summary: 
      Development of a bio-mathematical model of the human female cycle
    

Detailed description: 
      From hormonal measurements throughout 1-2 menstrual cycles in women with and without
      endocrinological pathology a mathematical model of the human menstrual cycle will be
      generated. The model will serve to predict development of the cycle including ovulation as
      well as to better understand the pathophysiology of endocrinological disorder. In a second
      step current treatment protocols for fertility treatment will be integrated into the model in
      order to optimize treatment outcome.
    

Intervention name(s): Fertility treatment
Intervention type(s): Other
Intervention description(s): Fertility treatment
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Women with normal and distrubed menstrual cycles Women receiving fertility treatment
      
Biospecimen description: 
      Probes to determine hormonal parameters
    
Keywords: menstrual cycle dynamics; PCOS; hyperprolactinemia; endometriosis; infertility
Fatigue and Exercise Training in Patients With Sarcoidosis
Condition: Sarcoidosis; Fatigue
MeSH terms: Sarcoidosis; Fatigue
Study type: Interventional

Summary: 
      The aims of the current study is to explore if different exercise training protocols affect
      fatigue post-exercise, and if sarcoidosis-related fatigue and maximal and sub-maximal
      cardiopulmonary exercise test (CPET) variables change after a 4-weeks exercise training
      period.
    

Detailed description: 
      This project aims to provide data on post-exercise fatigue after single exercise sessions
      with endurance training and muscle strength training, each with two different intensities.
      For endurance training; post-exercise fatigue will be assessed after one session of high
      intensity interval training, and one session with longer duration of moderate intensity. For
      muscle strength training, fatigue will be measured after one session with high loads/few
      repetitions and one session with low loads/many repetitions. In addition, changes in
      sub-maximal and maximal metabolic and ventilatory responses to a maximal cardiopulmonary
      exercise test on a treadmill (CPET) and association to sarcoidosis-related fatigue before and
      after a 4-weeks exercise training period will be studied.
    

Intervention name(s): Muscle strength training; Endurance exercise training
Intervention type(s): Other; Other
Intervention description(s): Two different muscle strength training protocols will be compared; one exercise session with high load/low repetitions (4 sets x 5RM) versus one exercise session with low load/high repetitions (2 sets x 25RM). Both session will be conducted at four different exercises; seated leg press, chest press, cable lat pull down and seated rowing.; Two different endurance exercise training protocols will be compared; one exercise sessions is interval training with high intensity (85-95% of HRmax) versus one of moderate intensity (70-75% of HRmax) with longer duration.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Sarcoidosis; Fatigue; Exercise
Efficacy and Safety of DaxibotulinumtoxinA for Injection for the Treatment of Adult Upper Limb Spasticity
Condition: Upper Limb Spasticity
MeSH terms: Muscle Spasticity
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, Double-Blind, Placebo-Controlled, Parallel Group, Dose-Ranging, trial
      to Evaluate the Efficacy and Safety of DaxibotulinumtoxinA for Injection for the Treatment of
      Upper Limb Spasticity in Adults After Stroke or Traumatic Brain Injury. The study will be
      conducted in the U.S.A., approximately 128 adult subjects from approximately 30 study centers
      will be randomly assigned (1:1:1:1) to one of four treatment groups. The study consists of a
      21-day screening period, a treatment visit and follow-up visits.

      The protocol was amended and the study was completed with fewer subjects than described in
      the initial protocol due to impact of COVID-19 on enrollment.
    

Detailed description: 
      Subjects will be randomly assigned to DAXI for Injection 250 U, DAXI for Injection 375 U,
      DAXI for Injection 500 U, or placebo group, respectively. Eligible subjects will have ULS
      characterized by a primary aggregate posture
    

Intervention name(s): DAXI for injection 250 U; DAXI for injection 375 U; DAXI for injection 500 U; Placebo
Intervention type(s): Biological; Biological; Biological; Other
Intervention description(s): DaxibotulinumtoxinA for injection is a sterile, white to off-white lyophilized product containing the active ingredient, daxibotulinumtoxinA, and inactive ingredients to be reconstituted with sterile, non-preserved, 0.9% sodium chloride solution saline; DaxibotulinumtoxinA for injection is a sterile, white to off-white lyophilized product containing the active ingredient, daxibotulinumtoxinA, and inactive ingredients to be reconstituted with sterile, non-preserved, 0.9% sodium chloride solution saline.; DaxibotulinumtoxinA for injection is a sterile, white to off-white lyophilized product containing the active ingredient, daxibotulinumtoxinA, and inactive ingredients to be reconstituted with sterile, non-preserved, 0.9% sodium chloride solution saline; Placebo is a sterile lyophilized product consisting of inactive ingredients without the neurotoxin to be reconstituted with sterile, non-preserved 0.9% sodium chloride solution.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Eligible subjects will be randomized (1:1:1:1) to one of four treatment groups: Group 1: DAXI 250 U (N=32); Group 2: DAXI 375 U (N=32); Group 3: DAXI 500 U (N=32); Group 4: Placebo (N=32).
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ULS; JUNIPER; DAXI for injection; Botulinum toxin
Comparison of Prilosec OTC® Versus Zegerid® for Gastric Acid Suppression
Condition: Normal Healthy Subject Population
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare Prilosec OTC® and Zegerid® in their effects on
      gastric acid suppression.
    


Intervention name(s): Zegerid®; Prilosec OTC®
Intervention type(s): Drug; Drug
Intervention description(s): capsule(20 mg omeprazole/sodium bicarbonate), single dose; Omeprazole-magnesium 20.6 mg, tablet, single dose
Intervention MeSH terms: Omeprazole; Omeprazole, sodium bicarbonate drug combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Effect of Linagliptin + Metformin on Patients Who do Not Achieve Normoglucemia With Metformine
Condition: Prediabetic State; Impaired Glucose Tolerance; Insulin Resistance
MeSH terms: Insulin Resistance; Glucose Intolerance; Prediabetic State
Study type: Interventional
Phase: Phase 4

Summary: 
      The goal of this protocol is to evaluate the effect of addhing linagliptin to patients with
      prediabetes who do not reverse to normoglycemia after 12 months of treatment with metformin
      alone. The duration of the study will be 6 months, and it is primarily a efficacy study. Main
      outcomes will be glucose levels during OGTT, insulin secretion and pancreatic beta cell
      function measured by the disposition index derived from the OGTT.
    

Detailed description: 
      Randomization and masking. Patients will be randomly assigned in a 1:1 ratio to receive
      linagliptin/metformin 2.5/850mg every 12 h + lifestyle modification program, or metformin
      850mg every 12 h + lifestyle modification program during 6 months. Randomization will be
      performed using an electronic random numbers table by a Nutritionist not involved in the
      study. Participants and investigators involved in the patients follow-up and outcome
      measurements will be masked to treatment allocation during the entire study.

      Patients will have a follow-up visit every month. Every appointment is about 30-45 minutes;
      medications tolerance and side effects will be recorded in every patients´ visit. Nutritional
      and physical activity assessment according to the patient´s weight will be performed by a
      Nutritionist every month. Monthly adherence to medications will be evaluated by pill
      counting; nutritional adherence and energy intake will be evaluated at 6 months by a food
      frequency questionnaire, and physical activity at 0 and 6 months. At basal and at 6 months
      patients will have an OGTT. Primary objective is to evaluate at 6 months glucose profile
      during OGTT, insulin secretion and pancreatic β-cell function by the OGTT DI, and regression
      to normoglycemia; T2D will be diagnosed and confirmed by at least two consecutive
      measurements of the same criteria: glycated haemoglobin ≥ 6.5 %, fasting glucose ≥ 126mg/dl,
      or 2 h glucose ≥ 200 mg/dl.
    

Intervention name(s): Linagliptin / Metformin Oral Tablet; Metformin
Intervention type(s): Drug; Drug
Intervention description(s): Linagliptin 2.5 mg + Metformin 850 mg twice daily plus a lifestyle modifications program; Metformin 850 mg twice daily plus lifestyle modifications program
Other intervention name(s): Combined treatment; Metformin alone
Intervention MeSH terms: Metformin; Linagliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Prediabetes; Insulin resistance; hyperglucemia
rTMS for the Treatment of Chronic Tinnitus: Optimization by Simulation of the Cortical Tinnitus Network
Condition: Chronic Tinnitus
MeSH terms: Tinnitus
Study type: Interventional

Summary: 
      Transcranial Magnetic Stimulation is used to modulate both the auditory and non-auditory
      neural pathways contributing to the perception of phantom sounds.
    

Detailed description: 
      Tinnitus is the phantom auditory perception of sound in the absence of an external or
      internal acoustic stimulus. It is a frequent problem which can interfere significantly with
      the ability to lead a normal life. Treatment remains difficult. Most available therapies
      focus on habituation rather than treating the cause. Tinnitus has been shown to be associated
      with functional reorganization of auditory neural pathways and tonotopic maps in the central
      auditory system. Consequently, low-frequency Repetitive Transcranial Magnetic Stimulation
      (rTMS) applied to the temporoparietal areas has been investigated for the treatment of
      tinnitus. Additionally, there is growing evidence that a neural network of both auditory and
      non-auditory cortical areas is involved in the pathophysiology of chronic subjective
      tinnitus. Targeting several core regions of this network by rTMS might constitute a promising
      strategy to enhance treatment effects. A new multisite treatment protocol which is supposed
      to have an effect on both auditory and non-auditory cortical areas will be examined with
      regard to feasibility, safety and clinical efficacy in patients suffering from chronic
      tinnitus in a controlled pilot trial.
    

Intervention name(s): rTMS intervention 1; rTMS intervention 2
Intervention type(s): Device; Device
Intervention description(s): Low frequency rTMS (Magventure Mag Pro Option) applied over left temporoparietal cortex: 3000 stimuli of 1Hz rTMS (110% motor threshold); 1 minute break after 1000 and 2000 stimuli.
Arms: single site rTMS; Repetitive transcranial magnetic stimulation (Magventure Mag Pro Option): 1000 stimuli of 20 Hz rTMS over the left DLPFC (110% motor threshold) followed by 1000 stimuli of 1 Hz rTMS over the left temporoparietal cortex (110% motor threshold) followed by 1000 stimuli of 1 Hz rTMS over right temporoparietal cortex (110% motor threshold).
Arms: multisite rTMS
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Tinnitus; chronic subjective Tinnitus; transcranial magnetic stimulation; rTMS; hearing disorders