bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Tolerability Study of Cotadutide in Japanese Obese Subjects With Type 2 Diabetes Melitus
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1 study designed to assess the safety and tolerability of MEDI0382
      (Cotadutide) in Japanese T2DM patients.
    

Detailed description: 
      This is a randomized, blinded, placebo-controlled study designed to evaluate the safety,
      tolerability, PK and efficacy of ascending doses of Cotadutide in Japanese obese subjects
      with T2DM. Approximately 20 subjects will be screened in total and 16 subjects will be
      randomized to Cotadutide or placebo in a 3:1 ratio. Those subjects who receive Cotadutide
      will be titrated up to HCTD. The study has a 2-week screening period, a run-in period of 9
      days and an up to 7-week up-titration treatment period followed by a 3-week treatment
      extension period (if applicable), followed by a 28-day follow-up period.
    

Intervention name(s): Placebo; Cotadutide
Intervention type(s): Drug; Drug
Intervention description(s): Placebo administered subcutaneously; Cotadutide administered subcutaneously
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Diabetes; Cotadutide; MEDI0382; D5671C00003; Type 2 Diabetes
Olmesartan Alone or in Combination With Hydrochlorothiazide in Subjects With Mild to Moderate Essential Hypertension
Condition: Essential Hypertension
MeSH terms: Hypertension; Essential Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      Efficacy, tolerability and safety of olmesartan alone or in combination with
      hydrochlorothiazide in the treatment of mild to moderate essential hypertension
    


Intervention name(s): olmesartan alone or in combination with hydrochlorothiazide
Intervention type(s): Drug
Intervention MeSH terms: Hydrochlorothiazide; Olmesartan
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Risk and Aesthetic Assesment in Implant Patient
Condition: Implant Assesment
Study type: Observational

Summary: 
      This study examines the peri-implant risk assessment diagram and the aesthetic, peri-implant
      health status, and gingival level around the implant in patients with implants by comparing
      them in smokers and non-smokers.

      : After completion of the examination, 298 dental implants for at least three months after
      functional prosthesis loading, except for patients with bruxism and uncontrolled diabetes,
      were included in the study. Patients are primarily divided into smokers and non-smokers. In
      all implant patients, plaque, gingival index, bleeding on probing, pocket depth, clinical
      attachment loss, gingival recession, keratinized thickness, keratinized width, vestibule
      depth, pink aesthetic score, and peri-implant disease risk analysis are evaluated in
      sequence.
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        298 dental implants for at least 6 months after functional prosthetic loading were included
        in the study. Patients are primarily divided into smokers and non-smokers.
      
Keywords: Implant disease risk assesment; Pink esthetic score; Implant quality scale; Periodontal health; Periodontal disease
Analysis of Imaging Features From Patients Treated With Brolucizumab in the Post-marketing Setting With Reports of Retinal Vasculitis and/or Retinal Vascular Occlusion
Condition: Intraocular Inflammation; Retinal Vascular Occlusion
MeSH terms: Uveitis; Retinal Vasculitis; Vasculitis; Inflammation
Study type: Observational

Summary: 
      This non-interventional descriptive study was undertaken to better understand the most common
      imaging features associated with inflammation arising in the post-marketing setting when
      brolucizumab was prescribed in routine clinical practice.
    

Detailed description: 
      The purpose of this retrospective study analysis was to better characterize the risk of
      inflammatory events arising from use of brolucizumab in routine clinical practice through
      analysis of independently reviewed ocular imaging data obtained from cases with reports of
      intraocular inflammation (IOI), retinal vasculitis (RV) and/or Retinal vascular occlusion
      (RO) and to provide a description of these features.

      Whenever an AE report pertaining to RV and/or RO was reported to Novartis Patient Safety, a
      follow-up check list (targeted follow-up checklists [TFUs]) was sent by Novartis to the
      reporter. The reporter was encouraged to share all available images obtained as part of
      clinical practice, irrespective of the timing or event (i.e. images before, during, and after
      event could be provided). The focus and main efforts of this data collection was on adverse
      events of RV and/or RO; for other IOI only events, the images were not actively requested in
      the case documentation process, however in some cases these were spontaneously reported by
      the reporter.

      All images obtained from Feb 2020 up to 31 Jan 2021 were reviewed in a standardized manner by
      an external reading center. Dedicated grading lists were developed for each of the image
      modalities: Fluorescein Angiography (FA), Fundus Photography (FP), Indocyanine Green
      Angiography (ICGA), Optical Coherence Tomography (OCT), and OCT Angiography (OCT-A).
    

Intervention name(s): Brolucizumab
Intervention type(s): Other
Intervention description(s): Participants with cases of RV and/or RO reported to Novartis Patient Safety following brolucizumab use in routine clinical practice for which images were provided to Novartis and read by the Reading Centre were included
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        As this study used secondary data from Novartis Patient Safety database, there was no
        specified set of subject population in this study and all cases with event of interest and
        available images were retrieved.
      
Keywords: Brolucizumab; Neovascular age-related macular degeneration; occlusive retinal vasculitis; retinal vasculitis; RV; retinal vascular occlusion; RO; ocular images
DOXAZOSIN FOR PTSD
Condition: PTSD
Study type: Interventional
Phase: Phase 1

Summary: 
      The aims of this study is to determine the effects of treatment with doxazosin XL 16 mg/d
      combined with virtual reality (VR) exposure therapy on Post Traumatic Stress Disorder.

      The effects of treatment with doxazosin XL 16 mg/d combined with virtual reality (VR)
      exposure therapy will be assessed in double-blind, placebo-controlled study. The study will
      enroll 30 participants. The investigators will use a within groups design in which all
      participants receive both placebo and doxazosin (N=16) with the order counterbalanced across
      participants. A second group of patients (N=16) will receive both 16mg perindopril and
      placebo instead of doxazosin/placebo.
    


Intervention name(s): doxazosin; Perindopril; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Perindopril; Doxazosin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: PTSD; treatment; virtual reality; doxazosin
Stenting and Angioplasty With Protection in Patients at High Risk for Endarterectomy (SAPPHIRE)
Condition: Carotid Artery Disease
MeSH terms: Carotid Artery Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study is to compare the safety and effectiveness of the Cordis
      Nitinol Carotid Stent and Delivery Systems (5.5 F and 7 F) with the ANGIOGUARD XP distal
      protective device to CEA in the treatment of carotid artery disease in patients at increased
      risk for surgery.
    


Intervention name(s): Cordis Nitinol Stent; PRECISE tapered stent; ANGIOGUARD XP Emboli Capture Guidewire (ECGW)
Intervention type(s): Device; Device; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Wound Etiology and Healing Study
Condition: Wounds; Hidradenitis Suppurativa; Hidradenitis; Acne Inversa
MeSH terms: Hidradenitis Suppurativa; Hidradenitis; Wounds and Injuries
Study type: Observational

Summary: 
      The purpose of the WE-HEAL Study is to help researchers use human tissue samples and health
      records to study the reasons why some patients heal quickly and some have problems healing
      wounds. All patients seen with an open wound or hidradenitis suppurativa are invited to
      participate. Information from this research may help to understand how to prevent and treat
      certain diseases.
    


Observational model: Ecologic or Community
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Non healing wounds or hidradenitis suppurativa
      
Biospecimen description: 
      1. Residual tissue left over after routine debridement surgery

        2. Wound fluid that would otherwise be discarded

        3. Residual blood/ serum samples left over after pre-surgery blood tests have been
           performed.

        4. Wound biofilm

        5. Wound photographs
    
Keywords: Non healing ulcer; Wound; Hidradenitis suppurativa; Acne Inversa; Hidradenitis
Clinical Trial of GX-I7 in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, randomized, double-blind, placebo-controlled, single ascending dose study
      designed to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of GX-I7
      in healthy volunteers.
    

Detailed description: 
      The subjects who are adequately eligible to attend this clinical trial via screening will be
      hospitalized one day prior to the injection (Day -1), administered a single dose of GX-I7
      solution for subcutaneous injection, and then discharged on Day 3. After completing all
      scheduled tests at the visit 8 (Day 28), safety-related data of each cohort will be evaluated
      by Independent Safety Monitoring Committee (SMC). Dose escalation will proceed under the
      principal investigator, medical monitor, and the sponsor's mutual approval, referring to
      SMC's evaluation.
    

Intervention name(s): GX-I7; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Interleukin-7 (IL-7) is T cell growth factor that can be used for treating lymphopenia patients. GX-I7 is a protein drug recombining human IL-7 and hybrid Fc (hyFc). HyFc made by Genexine is composed of hinge-CH2 region of Immunoglobulin D (IgD) and CH2-CH3 region of Immunoglobulin G4 (IgG4). The recombined region is not exposed and each region's characteristics can reduce immunogenicity and improve the efficacy of drug. Consequently, it will be able to treat the patients with lymphopenia in effective ways.; This is the placebo of GX-I7 described above.
Other intervention name(s): IL-7-hyFc; GX-17 vehicle (formulation buffer)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Screening
Keywords: Safety; Pharmacodynamics; Dose-Limiting Toxicity (DLT); Immunogenicity; Pharmacokinetics
Neural Biomarkers of Clozapine Response
Condition: Schizophrenia; Treatment-resistant Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders; Schizophrenia, Treatment-Resistant
Study type: Observational

Summary: 
      Clozapine has consistently shown to be a superior drug for psychosis in patients who do not
      respond to other treatments, but its mechanism of action remains unknown. The overall goal of
      this study is to examine the functional neural circuitry that underlies successful treatment
      with clozapine, which may lead to the identification of biomarkers that will allow for more
      efficient use of clozapine, as well as additional treatment targets for patients with
      refractory illness.
    

Detailed description: 
      A large number of patients with chronic psychotic disorders continue to have symptoms
      following unsuccessful trials with first-line antipsychotic drugs. For these patients with
      refractory psychosis, clozapine has consistently demonstrated superior efficacy. Clozapine is
      often underutilized and administered late in a patient's course of treatment, which leads to
      increased morbidity, unnecessary medication trials, and increased health care expenditure.
      Meanwhile, the mechanism of action underlying clozapine's novel effects remains unknown and
      has not been studied with modern neuroimaging methods. Identifying the neural mechanisms by
      which clozapine exerts its effects may lead to biomarkers that will facilitate efficient
      utilization of the drug, and introduce novel treatment targets. In patients with refractory
      psychotic symptoms, the proposed study will use resting-state and task-based functional MRI
      (fMRI) to examine the neural circuitry of efficacious treatment with a trial of clozapine.
      Patients will undergo fMRI scanning both before and after 12 weeks of treatment, with the
      aims of determining: baseline patterns of resting-state functional connectivity and
      task-based activation that predict response to treatment; and changes in resting-state and
      task-based functional circuitry associated with efficacious treatment. Results of this
      proposal may lead to biomarkers that will optimize treatment algorithms for psychotic
      disorders and facilitate drug development for refractory psychosis.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with schizophrenia or schizoaffective disorder who have failed treatment with two
        antipsychotic drugs and are beginning treatment with clozapine.
Study to Evaluate Analgesic Effect of IV Administration of Kappa Agonist CR845 For Hysterectomy Surgery
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary purpose of this study is to determine if CR845 is effective in treating the pain
      associated with a laparoscopic hysterectomy.
    

Detailed description: 
      Currently, the most widely used drugs to treat pain after surgery are opiates, such as
      morphine. Morphine works mainly by activating one of several types of opiate receptors that
      control some of our pain sensation - the so-called mu opiate receptors. These receptors are
      located in many areas of the brain and also outside of the brain. By activating these
      receptors, morphine provides significant pain relief, but also causes side effects that limit
      its use. Some of these side effects include: respiratory depression or arrest (slowed or
      stopped breathing), sedation (a state of calmness or extreme relaxation), euphoria (an
      exaggerated feeling of physical and mental well-being), constipation, nausea, vomiting, and
      drug addiction.

      In order to avoid the side effects of morphine and other mu opiates, the present experimental
      drug CR845 was designed to work at a different type of opiate receptor - called kappa - that
      can also provide pain relief, by acting on sensory nerves outside the brain. CR845 was
      designed to penetrate the brain much less than other opiate drugs, which should result in
      pain relief similar to that of morphine, but with fewer side effects. Because CR845 activates
      kappa receptors instead of mu receptors, the side effects are different than with a
      morphine-type drug. In particular, kappa opiates, such as CR845, do not cause respiratory
      depression or arrest, euphoria, constipation, drug tolerance, physical drug dependence or
      drug addiction. For these reasons, CR845 may present a distinct advantage over other opiates
      that are currently used for pain relief and post-operative pain in particular.
    

Intervention name(s): CR845; Placebo; CR845; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Single i.v. dose (0.04 mg/kg) administered preoperatively; Single i.v. dose administered preoperatively; Single i.v. dose (0.04 mg/kg) administered postoperatively for pain; Single i.v. dose administered postoperatively for pain
Other intervention name(s): Preoperative Active Dose; Preoperative Placebo Dose; Postoperative Active for Pain; Postoperative Placebo for Pain
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: pain; acute pain; visceral pain; kappa agonist; opioid analgesics; peripheral nervous system agents; physiological effects of drugs; surgery; hysterectomy; post-operative; post-operative complications
D-Serine for Enhancing Cognitive Retraining for the Treatment of Schizophrenia
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will examine the effectiveness of D-serine in increasing and sustaining the
      benefits of cognitive retraining in people with schizophrenia.
    

Detailed description: 
      This study is based on the hypothesis that by increasing NMDA receptor function in the brain
      and thereby increasing the capacity of the brain to both form new connections and strengthen
      existing connections, schizophrenic patients may derive both greater and sustained benefit
      from cognitive retraining.

      Patients with schizophrenia or schizoaffective disorder who are currently receiving
      antipsychotic medication will be randomly assigned in a double-blind manner to receive either
      D-serine (30 mg/kg) or placebo in addition to cognitive rehabilitation or a non-interactive
      placebo for 12 weeks.
    

Intervention name(s): D-serine; Cognitive retraining
Intervention type(s): Drug; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
A Two-Phase Clinical Study of the Minerva AURORA Ablation System
Condition: Menorrhagia Due to Benign Causes
MeSH terms: Menorrhagia
Study type: Interventional

Summary: 
      The primary objective of this study is to evaluate the use of the Aurora Ablation System in
      reducing menstrual blood loss at 12 months post-treatment. The occurrence of adverse events
      will be assessed along with an assessment of the reduction of uterine bleeding as measured by
      a pictorial blood loss assessment chart (PBLAC) or menstrual diary.
    


Intervention name(s): Aurora Endometrial Ablation System
Intervention type(s): Device
Intervention description(s): Ablation of the endometrial lining of the uterus using the Aurora System
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Excessive Uterine Bleeding; Menorrhagia; Endometrial Ablation
Clinical Evaluation of Fenugreek Seed Extract, a Nutraceutical in Patients With Type- 2 Diabetes
Condition: Type-2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      In the proposed study, hydroalcoholic Fenugreek seed extract will used add-on to the existing
      therapy in patients with type-2 diabetes. The efficacy and safety of the extract will be
      evaluated using standard methodology.
    

Detailed description: 
      Trigonella foenum-graecum, commonly known as Fenugreek, is a plant that has been extensively
      used as a source of antidiabetic compounds, from its seeds, leaves and extracts in different
      systems of medicine in asia. Fenugreek is traditionally used in India, especially in the
      Ayurvedic and Unani systems. Preliminary animal and human studies suggest possible
      hypoglycemic and anti-hyperlipidemic properties of fenugreek seed powder taken orally. In a
      randomized placebo controlled study conducted by Gupta et al showed that two month treatment
      with the hydro-alcoholic extract of fenugreek seeds improved glycemic control in 12
      non-insulin dependent diabetes mellitus patients. In addition, there was improvement in
      insulin sensitivity and plasma lipid profile. Fenugreek extract was also well tolerated in
      diabetic patients.

      In the proposed study, hydroalcoholic Fenugreek seed extract will used add-on to the existing
      therapy in patients with type-2 diabetes. The efficacy and safety of the extract will be
      evaluated using standard methodology.
    

Intervention name(s): Oral hypoglycemic agents (pre-specified) [Metformin, Sulfonylurea]; Fenugreek Seed extract
Intervention type(s): Drug; Dietary Supplement
Intervention description(s): Patients receiving either of the following oral hypoglycemic agents
Sulfonylurea based oral hypoglycemic agents
Metformin based oral hypoglycemic agents
Metformin plus Sulfonylurea based oral hypoglycemic agents; Patients recruited in the study arm will receive Capsule Fenfuro 500 milligram twice daily for 12 weeks as add-on intervention to the pre-specified oral hypoglycemic agents therapy
Other intervention name(s): Metformin, Sulfonylurea; Capsule Fenfuro 500 mg
Intervention MeSH terms: Metformin; Hypoglycemic Agents; Fenugreek seed meal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Fenugreek seed extract; HbA1c; Blood glucose
Cytarabine (Ara-C) in Children With Acute Promyelocytic Leukemia (APL)
Condition: Leukemia
MeSH terms: Leukemia; Leukemia, Promyelocytic, Acute
Study type: Interventional
Phase: Phase 4

Summary: 
      Several groups, especially the PETHEMA group (in their LPA96 and 99 trials), obtained low
      relapse rates in newly diagnosed Acute Promyelocytic Leukemia (APL) patients by combining
      ll-transretinoic acid (ATRA) and anthracyclines without Ara-C, suggesting that avoiding Ara-C
      in the chemotherapy of APL reduced treatment toxicity without increasing relapses. While the
      relapse rate for the children with white blood cell(WBC) counts greater than 10×109/L at
      presentation were higher than those WBC counts less than 10×109/L (31% and 3.5%,respectively)
      in the LPA96 and 99 trials. A recent adult randomized trial show that avoiding Ara-C leads to
      an increased risk of relapse in the APL patients with WBC counts less than 10×109/L. The role
      of the Ara-C remains controversial. And there are very limited data reported on children with
      APL so far.
    

Detailed description: 
      Some studies suggest patients with high-risk disease should be treated with intensified doses
      of anthracycline, or intermediate/ high-dose Ara-C or As2O3 as an early consolidation, so as
      to decrease the risk of relapse.However, a higher cumulative dose of anthracycline may lead
      to cardiac toxicity, especially for children. In addition, containing Ara-C will led to more
      therapy-related toxicity. The benefit to add Ara-C to the schedules is questionable and
      remains a matter of investigation in children.
    

Intervention name(s): DNR:; Ara-c
Intervention type(s): Drug; Drug
Intervention description(s): DNR：45mg/m2 d1-3; DNR+ARA-C：DNR：45mg/m2 d1-3;Ara-C :1g/m2 d1-3
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ara-c; As2O3; pediatric; acute