bioihbjkbjnl/mcl2 huggingface dataset:
Comparison of CDB-2914 Versus Placebo in the Prevention of Follicular Rupture Post-luteinizing Hormone (LH) Surge
Condition: Contraception
MeSH terms: Rupture
Study type: Interventional
Phase: Phase 2

Summary: 
      Evaluation of the effect of a single dose of CDB-2914, as compared to placebo, administered
      after the onset of the LH surge on the outcome of the leading ovary follicle:

        -  echographic follicle rupture

        -  inhibition of follicle rupture

        -  luteal phase progesterone levels

        -  anovulatory progesterone levels
    


Intervention name(s): CDB-2914 (ulipristal acetate); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): single oral dose of 30 mg; single oral dose
Intervention MeSH terms: Ulipristal acetate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Dose Escalation Study in Female Subjects With Breast Cancer Receiving Aromatase Inhibitor or Tamoxifen
Condition: Vasomotor Symptoms (VMS)
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      Open-label, two dose study of Q-122, over a 4 week treatment period to explore the effects of
      Q-122 in a population of women with a history of breast cancer taking an aromatase inhibitor
      or tamoxifen.
    

Detailed description: 
      Vasomotor symptoms are significant in postmenopausal women with the most effective
      medications for relief being hormonal preparations. Non-hormonal medications have
      demonstrated efficacy but at a far lower level than estrogen replacement therapy. For women
      with a history of breast cancer hormone replacement therapy is problematic especially if
      their therapeutic regime involves an aromatase inhibitor. Therefore, this study will explore
      the effect of Q-122 in a population of women with a history of breast cancer taking an
      aromatase inhibitor or tamoxifen.

      The study is an open-label, two dose study (Group 1: 100 mg once daily and Group 2: 200 mg
      once daily) of Q-122, over a 4 week treatment period. As eligible subjects are enrolled, they
      will be assigned to Group 1 until Group 1 is fully enrolled. Dose escalation to the 200 mg
      level will only occur following a review of the safety experience of at least 6 subjects
      treated with 100 mg Q-122 once daily for at least 2 weeks. Once Group 1 is fully enrolled,
      eligible subjects will be enrolled into Group 2.

      A two-week screening phase will be used to establish a stable baseline of vasomotor symptoms
      and to establish study eligibility. Qualified subjects will be treated with Q-122 for four
      weeks either at 100 mg/day dose or the 200 mg/day dose, during which time they will be
      evaluated for safety, tolerability, and pharmacokinetics of Q-122 and tamoxifen levels;
      subjects will continue to record their hot flashes in identical fashion to the screening
      period. Following the 28 day treatment, period subjects who complete the study will continue
      to record their hot flashes for a two week follow up period.
    

Intervention name(s): oral capsule of Q-122
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: open-label, two dose study
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Vasomotor Symptoms, Breast Cancer, Hot Flashes, Tamoxifen, Aromatase Inhibitors, Estrogen Antagonists, Hormone Antagonists, Hormones, Hormone Substitutes; Hormone Antagonists, Physiological Effects of Drugs, Antineoplastic Agents, Hormonal Antineoplastic, Selective Estrogen Receptor Modulators; Estrogen Receptor Modulators, Bone Density Conservation Agents, Steroid Synthesis Inhibitors, Enzyme Inhibitors, Molecular Mechanisms of Pharmacological Action
Safety and Efficacy of the Alpha AMS Subretinal Implant
Condition: Retinitis Pigmentosa
MeSH terms: Retinitis; Retinitis Pigmentosa
Study type: Interventional

Summary: 
      The aim of this single-centre study is to assess the safety and efficacy of the Retina
      Implant Alpha AMS (Retina Implant AG, Reutlingen, Germany) in participants with severe visual
      impairment secondary to outer retinal degeneration caused by retinitis pigmentosa (RP). The
      study is sponsored by the University of Oxford and funded by the National Institute for
      Health Research (UK).
    

Detailed description: 
      The specific research questions are, i) can the implant partially restore vision to an eye
      with no light perception and ii) what are the safety implications for the ocular and
      periorbital tissues of the implanted eye? In advanced RP the light detecting photoreceptor
      cells of the retina degenerate slowly over time, and may eventually lead to blindness. The
      subretinal implant replaces the degenerate photoreceptor layer and stimulates the residual
      overlying healthy retinal layers in response to a light stimulus. These signals are then
      carried on to the brain along the normal visual pathway. Investigators are seeking to recruit
      six participants who fulfill the eligibility criteria, which include advanced RP with no
      useful light perception vision in the eye to receive the implant. Participants must be aged
      between 18 and 70 years old, be highly motivated, and be well enough for a general
      anaesthetic. The eye must have also had cataract surgery. The project will be conducted at
      the Oxford Eye Hospital. Those participants selected to receive the implant will be followed
      for 12 months from the date of surgery. Between week 1 and month 12 there will be at least 7
      outpatient clinic visits for a range of visual tests and eye assessments. After 12 months the
      trial will officially end, however investigators will continue to review all research
      participants in clinic as would be standard care for a patient with RP. The implant may be
      removed at any stage e.g. when it ceases to function or at the participant's request.
    

Intervention name(s): Implant 'on' vs implant 'off'
Intervention type(s): Device
Intervention description(s): Single group assignment
Other intervention name(s): Alpha AMS; Retinal Implant Alpha AMS; Retinal implant; Bionic eye; Retinal prosthesis; Sub retinal chip
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Phase I/II a Study of Decitabine in Combination With Genistein in Pediatric Relapsed or Refractory Malignancies
Condition: Cancer
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This Phase I/IIa study will test the combination of the epigenetic drug decitabine with the
      isoflavone genistein in children with leukemias and solid tumors. For the phase I study, the
      maximum tolerated dose will be evaluated in pediatric patients with relapsed or refractory
      leukemia and solid tumors. For the phase II study, only patients with relapsed or refractory
      leukemias will be included. To further evaluate the treatment efficacy and gain further
      insight into action of these drugs, the DNA methylation levels before and after treatment for
      all participants, pharmacokinetics parameters such as through level for decitabine and
      through and peak level for genistein will be measured. Pharmacogenomics testing for
      decitabine will be performed prior to cycle 1 of treatment.

      Decitabine will be administered over a 24 hours infusion on day 1 of cycle (28 days) and
      genistein will be taken orally twice daily from day 2 to 21, followed by a 7 days rest
      period.
    


Intervention name(s): Decitabine and Genistein
Intervention type(s): Drug
Intervention description(s): intravenous Decitabine with oral genistein
Intervention MeSH terms: Decitabine; Genistein
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Preventive Care of Chronic Cervical Pain and Disabilities
Condition: Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      The aim of this study is to determine which of tertiary prevention spinal manipulative
      therapy (SMT) or a home exercise program is the more efficient approach to reduce pain and
      increase functional capacity, quality of life and general health condition. To do so, 60
      participants with chronic cervical pain, will be recruited and divided into 3 groups
      according to the intervention they will receive: control group, experimental group 1 who will
      receive preventive chiropractic care in the form of spinal manipulations and experimental
      group 2 will have to perform an individualized home exercise program on a daily basis. We
      hypothesize that a group of patient receiving SMT + a home exercise program will present less
      pain and functional disabilities over a 1 year period. The innovative value of this project
      is mainly related to the fact that it will generate new and potentially very useful data
      concerning the clinical significance of preventive chiropractic care. Moreover, such data
      will be beneficial to our profession as chiropractic makes a step towards prevention,
      wellness and public health.
    


Intervention name(s): spinal manipulation; Spinal manipulation + exercises
Intervention type(s): Other; Other
Intervention description(s): Monthly cervical spinal manipulation; Monthly cervical spine manipulation and daily home exercises
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Awareness and Attitude of Cancer Patients About Participation in Clinical Research (CR) in Saudi Arabia
Condition: Oncology [See Also, Affected System]
MeSH terms: Neoplasms
Study type: Observational [Patient Registry]

Summary: 
      Enrollment of patients in CR may be impacted by their levels of awareness and attitude toward
      participation. Our study aims at assessing the awareness and willingness to participate in CR
      and identifying the barriers and influencing factors for participation.

      A cross-sectional study was performed using an interview-based questionnaire composed of
      close-ended questions conducted by trained research coordinators. Descriptive statistics,
      univariate and multivariate analyses were applied.
    

Detailed description: 
      Clinical Trials are essential for the identification of effective therapies in modern
      medicine. As the biomedical understanding of diseases increases, a growing number of new
      opportunities will require increasing numbers of patients agreeing to participate in a
      clinical trial

      Public awareness about the need for clinical research and the benefit beyond participation is
      important. Although the main objective of clinical trials is to provide a high standard of
      care and help in advancement of medical knowledge, only a small portion of patients receive
      treatment as part of a formal clinical trial

      Misconceptions about clinical trials are frequent, primarily due to lack of adequate
      information from the treating physician; the complexity of the study procedure; preferences
      of patients regarding a particular treatment or no treatment; uncertainty and the
      experimental nature of a clinical trial (additional side effects, less known about the
      treatment) and concern about confidential information are some of the significant barriers to
      participation. Healthy individuals and patients do not have the same perception, since
      patients have stressed and vulnerable feelings after diagnosis of their illness having a
      negative impact on patient's attitude towards a trial.

      The ability to recruit patients for future clinical trials will depend, in part, on
      understanding the barriers of participation in clinical trials. Unfortunately, there is no
      data about the public awareness and attitudes toward participation in clinical trials in
      Kingdom of Saudi Arabia. It is the purpose of this study to address this issue to create some
      baseline data to increase the accrual rate of clinical trials.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The study is planned to take place among Oncology patients ( inpatient and outpatient).
      
Keywords: awareness, clinical research, Saudi arabia
Bioequivalence Study of 2 Sizes of SHR4640 Tablets Orally in Healthy Subjects
Condition: Hyperuricemia
MeSH terms: Hyperuricemia
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is being conducted to evaluate the pharmacokinetic, and safety of two sizes of
      SHR4640 tablets in healthy adults, to explore the bioequivalence between two sizes of SHR4640
      tablets.
    


Intervention name(s): SHR4640; SHR4640
Intervention type(s): Drug; Drug
Intervention description(s): SHR4640, 2.5mg*4 - 10mg*1; SHR4640, 10mg*1 - 2.5mg*4
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized, Open, Single Dose, Two Sequences, Two Cycles, Self-Crossover Control
Masking: None (Open Label)
Primary purpose: Treatment
Social Cognition Dysfunctions in Parkinson's Disease
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Observational

Summary: 
      Parkinson's disease (PD) is usually responsible of cognitive and behavioral non-motor signs
      with a major impact on the quality of life. Social cognition is a complex system relying on
      emotion recognition (neurons mirror system (NMS)), the theory of mind (with its two parts:
      emotional and cognitive), but also on the social and cultural environment and the personal
      history. The first step in this model is represented by the NMS, which seems to be altered in
      PD patients for both positive and negative emotions as shown in our preliminary study. The
      investigator purpose is to investigate the role of the treatment (levodopa and deep brain
      stimulation) on the functioning of the NMS
    


Intervention name(s): social cognition tests; Quality of life self-questionnaire
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The evaluation of social cognition will be carried out using questionnaires and a point lights computer test. During the computer test, participants have to watch several short sequences of interactions between two silhouettes and give an interpretation of the scene.
Patients will be evaluated twice: one time before the surgery and a second time 1 year after surgery.
Healthy volunteers will be evaluated only one time.; Quality of life will be assessed using a self-administered questionnaire in the patients group only.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients likely to participate in the study and verifying the eligibility criteria will be
        identified within the Neurology C department as part of their neurological follow-up before
        and after deep brain stimulation.

        Healthy volunteers will be recruited among the spouses of the patients or via association
        like France Parkinson.
      
Keywords: Parkinson Disease; emotional recognition; Deep Brain Stimulation
Effect of Dialysate Temperature on Haemodynamic Stability and Haemodialysis Efficiency
Condition: Acute Renal Failure; Chronic Renal Failure
MeSH terms: Renal Insufficiency; Kidney Failure, Chronic; Acute Kidney Injury
Study type: Interventional

Summary: 
      Comparison between dialysate temperatures on haemodynamic stability and haemodialysis
      efficiency.
    

Detailed description: 
      Comparison of 4 different dialysate temperatures for haemodialysis of patients with chronic
      renal failure.

      Comparison of 3 different dialysate temperatures for haemodialysis of patients with acute
      renal failure.

      Investigation of the efficiency of haemodialysis of patients with acute renal failure
    

Intervention name(s): Haemodialysis with different dialysate temperatures
Intervention type(s): Procedure
Intervention description(s): Haemodialysis with different dialysate temperatures is used.
Intervention MeSH terms: Dialysis Solutions
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pentoxifylline in Patients With Nonalcoholic Steatohepatitis
Condition: Nonalcoholic Steatohepatitis
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      One third of the population in the United States has nonalcoholic fatty liver disease
      (NAFLD). Nonalcoholic steatohepatitis (NASH), the progressive form of NAFLD, can lead to
      cirrhosis.Currently, there is no proven therapy for patients with NASH. The investigators
      core hypothesis is that therapy of patients with NASH with pentoxifylline (PTX) for one year
      will result in improvement of biochemical parameters of liver disease and hepatic histology.
      The focus of this proposal is on the effectiveness of pentoxifylline (PTX) in improving
      laboratory and tissue parameters of liver disease, parameters of insulin-resistance, and
      levels of cytokines in patients with NASH.
    


Intervention name(s): pentoxifylline (PTX); placebo
Intervention type(s): Drug; Drug
Intervention description(s): 400 mg PO tid; placebo tid
Intervention MeSH terms: Pentoxifylline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Fatty Liver; Nonalcoholic fatty liver disease (NALFD); NAFLD; Nonalcoholic steatohepatitis (NASH); NASH; pentoxifylline
Bronchospasm Associated With High Nitric Oxide
Condition: Asthma; Airway Hyperresponsiveness
MeSH terms: Bronchial Spasm; Respiratory Hypersensitivity
Study type: Observational

Summary: 
      Intraoperative bronchospasm challenges anesthesia's safety. This study aims to investigate
      high concentration of exhaled nitric oxide as a marker of intraoperative bronchospasm.
    

Detailed description: 
      Previous studies in asthmatic patients suggested that exhaled nitric oxide may represent a
      noninvasive measure for airway inflammation. Anesthesia information forms from 1999
      throughout 2004 were revised (n=146.358). Bronchospasm occurrence appeared registered on 863
      forms. From those, nine were identified as non-asthmatics patients (Bronchospasm group).
      Also, 12 asthmatics constituted one additional group (Asthma group) and 10 subjects with no
      previous airway disease or symptoms (Control group). All subjects were submitted to Exhaled
      nitric oxide measurements (parts/billion), spirometry and induced sputum.
    

Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Hospital, late post-anesthesia cared patients
      
Biospecimen description: 
      Sputum
    
Keywords: nitric oxide; bronchospasm; anesthesia; induced sputum; asthma
Sustained Release Formulation of Somatropin (rDNA Origin)for Injection
Condition: Growth Hormone Deficiency
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Annualised height velocity after 12/24 months treatment and HV SDS height velocity after
      12/24 months treatment expressed as number of standard deviations difference from the mean
      population height velocity for the appropriate gender and chronological age.
    

Detailed description: 
      To evaluate the safety, efficacy and pharmacokinetics/ pharmacodynamics of LB03002 in the
      treatment of growth failure in children with growth hormone deficiency (GHD) and to determine
      the dose for a subsequent phase IIIb BPLG-004 study
    

Intervention name(s): BPLG-003
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: SR-hGH, Pharmacokinetics, Pharmacodynamics
Epiction of the Genomic and Genetic Landscape Identifies CCL5 as a Protective Factor in Colorectal Neuroendocrine Carcinoma
Condition: Colorectal Neuroendocrine Carcinomas (CRNEC); Genomic Landscape; Genetic Landscape; Prognosis; CCL5; PAX5
MeSH terms: Carcinoma; Carcinoma, Neuroendocrine
Study type: Observational

Summary: 
      Background: Colorectal neuroendocrine carcinomas (CRNECs) are highly aggressive tumours with
      poor prognosis and low incidence. To date, the genomic landscape and molecular pathway
      alterations have not been elucidated.

      Methods: Tissue sections and clinical information were collected as an in-house cohort
      (2010-2020). Large-scale genomic and genetic panels were applied to identify the genomic and
      genetic alterations of CRNEC. Through the depiction of the genomic landscape and
      transcriptome profile, we compared the difference between CRNEC and CR neuroendocrine tumours
      (CRNETs). Immunohistochemistry (IHC) staining and immunofluorescence (IF) staining were
      performed to confirm the genetic alterations.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Asia
Study of Weight Loss Using Gastric Stimulation in Obese Patients With Type 2 Diabetes
Condition: Severe to Morbid Obesity and Type 2 Diabetes
MeSH terms: Obesity; Diabetes Mellitus, Type 2; Obesity, Morbid
Study type: Interventional

Summary: 
      The purpose of this study is to test the effect of an implanted device that stimulates the
      stomach on weight loss in patients suffering from obesity and type 2 diabetes.
    


Intervention name(s): Enterra Therapy System (H9900014)
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Obesity; Morbid obesity; Diabetes