bioihbjkbjnl/mcl2 huggingface dataset:
Study to Assess the Efficacy and Safety of Three Dosage Strengths of Pulsatile GnRH Delivered From a Iontophoretic Patch Compared to Oral Treatment With Clomiphene or Placebo in Infertile Females
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to determine the safety and efficacy of pulsatile GnRH
      delivered from a iontophoretic patch (Lutrepatch) for induction of ovulation in women with
      anovulatory/ oligoovulatory infertility, compared to placebo and to a reference treatment
      with clomiphene citrate.
    


Intervention name(s): GnRH iontophoretic transdermal Lutrepatch; GnRH iontophoretic transdermal Lutrepatch; GnRH iontophoretic transdermal Lutrepatch; clomiphene citrate; placebo clomiphene citrate; placebo GnRH patch
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 10 mg GnRH iontopheretic transdermal patch. A new patch is applied two times each day (every 12 hours). Delivery current and membrane thickness adjusted to deliver the 'high target' study dose, which is estimated to be 800 picograms/ml; 10 mg GnRH iontopheretic transdermal patch. A new patch is applied two times each day(every 12 hours). Delivery current and membrane thickness adjusted to deliver the 'medium target' study dose, which is estimated to be 400-600 picograms/ml; 10 mg GnRH iontopheretic transdermal patch. A new patch is applied two times each day (every 12 hours). Delivery current and membrane thickness adjusted to deliver the 'low target' study dose, which is estimated to be 200 picograms/ml; Oral, 50 mg daily for 5 days; oral, taken for 5 days; Placebo transdermal patch with a high target delivery of placebo(every 90 minutes). New patch to be applied every 12 hours.
Other intervention name(s): Lutrepatch; Gonadotropin-releasing hormone (GnRH); Gonadotropin-releasing hormone (GnRH); Lutrepatch; Gonadotropin-releasing hormone (GnRH); Lutrepatch; various tradenames
Intervention MeSH terms: Citric Acid; Sodium Citrate; Clomiphene; Enclomiphene; Zuclomiphene; Hormones; Prolactin Release-Inhibiting Factors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: anovulatory/oligoovulatory infertility
Renal Denervation by MDT-2211 System in Patients With Uncontrolled Hypertension
Condition: Uncontrolled Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      The objective of this study is to demonstrate that the MDT-2211 renal denervation system is a
      safe and effective treatment for uncontrolled hypertension subjects despite treatment with 3
      or more anti-hypertensive medications of different classes, of which one must be a diuretic,
      as best available antihypertensive therapy
    

Detailed description: 
      The HTN-J study is a multi-center, prospective, unblinded, randomized, controlled study of
      the safety and effectiveness of renal denervation in subjects with uncontrolled hypertension.
      Bilateral renal denervation will be performed using the MDT-2211 renal denervation system - a
      percutaneous system that delivers radiofrequency (RF) energy through the luminal surface of
      the renal artery.
    

Intervention name(s): MDT-2211 Renal Denervation System
Intervention type(s): Device
Intervention description(s): A percutaneous system that delivers radiofrequency (RF) energy through the luminal surface of the renal artery.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hypertension; Vascular Diseases; Cardiovascular Diseases; Renal denervation
Anlotinib Combined With Niraparib Dual Therapy in Platinum-resistant Recurrent Ovarian Clear Cell Carcinoma.
Condition: Platinum-resistant Recurrent Clear Cell Ovarian Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Recurrence
Study type: Interventional
Phase: Phase 2

Summary: 
      According to the definition of National Comprehensive Cancer Network (NCCN), ovarian clear
      cell carcinoma (OCCC) is a less common subtype of epithelial ovarian cancer (EOC) . The
      preliminary trial ANNIE (NCT04376073) shows a promising efficacy and safety profile for the
      ANNIE combo (anlotinib+niraparib). There is limited progress in targeted therapy for those
      less common ovarian cancers. In this study (CC-ANNIE), we aim to evaluate the antitumor
      activity and safety of niraparib combined with anlotinib in patients with platinum-resistant
      or platinum-refractory OCCC.
    

Detailed description: 
      The CC-ANNIE trial is a single-arm, single-center, exploratory phase II trial. Eligible
      patients (≥18 & ≤70 years) are histologically confirmed platinum-resistant recurrent OCCC and
      20 subjects are planned to be enrolled. All subjects must have measurable lesions (according
      to Response Evaluation Criteria in Solid Tumors [RECIST] 1.1) and are going to be treated
      with niraparib 200mg once daily, anlotinib 10mg on day 1-14 of each 21-day cycle thereafter
      until disease progression or intolerable toxicity. The primary endpoint is the objective
      response rate.
    

Intervention name(s): Niraparib; Anlotinib
Intervention type(s): Drug; Drug
Intervention description(s): Niraparib 200mg po QD, day1~21; Anlotinib 10mg po QD, day1~14, 3 weeks/cycle
Intervention MeSH terms: Niraparib
Intervention model: Single Group Assignment
Intervention model description: Drug: Niraparib Niraparib 200mg po QD day1~21 Drug: Anlotinib Anlotinib 10mg po QD day1~14.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: clear cell ovarian cancer; Platinum-resistant cancer; Niraparib; Anlotinib
Clarksdale Diabetes and Metabolism Clinic CHEC Study
Condition: Diabetes
MeSH terms: Diabetes Mellitus
Study type: Observational

Summary: 
      This study will involve established clinic patients. The Rapid Estimate of Adult Literacy in
      Medicine will be administered during patients' regular clinic visits. Patients will then be
      referred to the Consumer Health Education Center (CHEC)by healthcare providers who will fill
      out a referral form. The form will be given the the CHEC health educator who will assist
      patients in finding literacy-appropriate health information. BMI and Hgb A1c values will be
      compared after 3 months and 6 months to baseline values. It is hypothesized that objective
      assessment of patient use of literacy-appropriate, health information from the Clarksdale
      Diabetes and Metabolism Clinic CHEC will improve Hgb A1c and BMI values among patients.
    


Intervention name(s): Education
Intervention type(s): Behavioral
Intervention description(s): Patients will receive literacy appropriate health information.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Established patients at a diabetes clinic.
      
Biospecimen description: 
      No biospecimens are retained
    
Keywords: Diabetic patients at the Clarksdale Diabetes; and Metabolism Clinic and must be between the; ages of 18 and 64 years of age.
Acceleration of Alignment of Crowded Lower Anterior Teeth
Condition: Malocclusion, Angle Class I; Crowded Teeth
MeSH terms: Malocclusion; Malocclusion, Angle Class I
Study type: Interventional

Summary: 
      Patients at the Orthodontic Department of University of Damascus Dental School will be
      examined and subjects who meet the inclusion criteria will be included. Then, initial
      diagnostic records (diagnostic gypsum models, internal and external oral photographs, as well
      as radiographic images) will be studied to ensure that the selection criteria are accurately
      matched.

      The aim of this study is to compare two groups of patients with moderate crowding of the
      lower anterior teeth First group (Experimental): the patients in this group will be treated
      with orthodontic fixed appliances + surgery to the alveolus of the lower anterior teeth in
      order to induce remodeling of the bony structures and enhance orthodontic movement.

      Second group (Control): the patients in this group will be treated using fixed appliances
      with any acceleration method.
    


Intervention name(s): periodontally accelerated osteogenic orthodontics
Intervention type(s): Procedure
Intervention description(s): Surgery will be performed to the lower anterior bony segment of the lower jaw in order to accelerate tooth movement
Other intervention name(s): PAOO
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
A Safety and Tolerability Study of 42037788 (Referred to as CNTO 0007) Compared With Placebo in Patients Who Have Experienced Ischemic Cerebral Infarction (Also Known as Stroke)
Condition: Stroke; Ischemia; Infarction
MeSH terms: Stroke; Cerebral Infarction; Ischemia; Infarction
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and tolerability of 42037788 (CNTO 0007)
      in patients who have suffered a stroke. The study is not designed to establish efficacy,
      although preliminary explorations will be conducted.
    

Detailed description: 
      This is a first-in-human (FIH) study of 42037788 (referred to as CNTO 0007), a cell therapy
      being tested to see if it may be useful in treating patients with ischemic cerebral
      infarction also known as stroke. Patients will be randomized (assigned by chance) to receive
      a single dose of CNTO 0007 or placebo (identical in appearance to CNTO 0007 but does not
      contain cells) by intravenous (IV) infusion (injection directly into a vein). Patients and
      study staff will not know if patients are assigned CNTO 0007 or the placebo. The study will
      be conducted in 2 stages (Stage A and Stage B). In Stage A, the highest dose of CNTO 0007
      that does not cause unacceptable side effects, referred to as the maximum tolerated dose
      (MTD) will be determined to and administered to patients in Stage B of the study. In Stage A,
      5 (up to 7) cohorts (groups) of 4-8 patients each will be administered a single IV infusion
      of CNTO 0007 or placebo 1-5 days (depending on cohort) after stroke (the first cohort of
      patients will receive the lowest dose of CNTO 0007 or placebo and each subsequent cohort will
      be administered a higher dose of CNTO 0007 or placebo until the MTD is determined). In Stage
      B, patients will be administered a single IV infusion of the MTD within a specified number of
      days after stroke.
    

Intervention name(s): CNTO 0007 or placebo (Stage A); CNTO 0007 or placebo (Stage B)
Intervention type(s): Drug; Drug
Intervention description(s): a single IV infusion of a selected dose of CNTO 0007 or placebo administered IV within 1-5 days (depending on cohort) after stroke (first cohort of patients will receive the lowest dose of CNTO 0007 or placebo and each subsequent group will be administered a higher dose (to be determined); a single IV infusion of the MTD of CNTO 0007 or placebo administered IV within a specified number of days after stroke
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ischemic Cerebral Infarction; Stroke; CNTO0007; 42037788
Effect of Pirfenidone on Glomerular Filtration Rate and Albuminuria in Patients With Diabetic Nephropathy
Condition: Diabetic Nephropathy; Albuminuria
MeSH terms: Kidney Diseases; Diabetic Nephropathies; Albuminuria
Study type: Interventional
Phase: Phase 3

Summary: 
      It is estimated that approximately 30% of patients with diabetes develop diabetic
      nephropathy. Diabetic nephropathy is a multifactorial progressive disease that occurs through
      various mechanisms such as hyperglycemia, oxidative stress, inflammation and fibrosis,
      control or blocking these mechanisms are therefore potential therapeutical targets for this
      entity. Current treatment options are based on the glycemic control, blood pressure control,
      as well as the use of medications such as angiotensin-converting enzyme inhibitors and
      Angiotensin II receptor antagonists, these actions are not enough to stop progression.
      Pirfenidone is a drug with antifibrotic, antioxidant, and anti-inflammatory properties.
      Although the specific mechanism is unknown, pirfenidone interferes with the expression,
      secretion and the effect of the β (TGF-β) transforming growth factor. The investigators plan
      to carry out a controlled clinical study to evaluate the effect of pirfenidone in patients
      with type 2 diabetes and nephropathy. The period of time the treatment will be administered
      will be of 12 months, 62 patients will be included. The primary outcome will be improvement
      in glomerular filtration rate. The secondary outcomes will be number of patients requiring
      replacement therapy, 24 hour urine microalbuminuria and change in the concentration of TGF -
      β. Change in these parameters will be evaluated at the end of the treatment period (12
      months). Throughout the study the incidence of adverse events will be recorded, wich will
      allow us to learn about the safety and security of the drug in this population.
    


Intervention name(s): Pirfenidone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral pirfenidone 600 mg with breakfast and 1200 mg pirfenidone with dinner for 12 months.; Identical tablets without active substance
Other intervention name(s): Kitoscell LP
Intervention MeSH terms: Pirfenidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Pirfenidone; Diabetic nephropathy
Take Charge of Your Diabetes
Condition: Diabetes; Hypertension
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      The investigator plans to assess enrollment rates among two different enrollment methods,
      while providing a behavioral economic intervention to enhance the uptake of home-health
      monitoring devices to lower hemoglobin A1C among patients with uncontrolled diabetes. The
      study is focusing on enrollment methods since the standard randomized control trial only
      reaches 15% of the population. The study is seeking to understand the effectiveness of a
      behavioral intervention, when rolled out in a larger population.
    


Intervention name(s): Financial Incentive: Fixed Lottery
Intervention type(s): Behavioral
Intervention description(s): Every day of the 91 day intervention period participants will be asked to use each of their biometric devices. A daily lottery will be conducted automatically by the study website. Participants must use each of their two devices daily to be eligible for the lottery the following day. Winning lottery numbers will be identified by a fixed-position match between the automatically generated winning number and a participant ID number, which each participant will pick at enrollment.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Keywords: Diabetes; Enrollment methods; Behavioral Economic Intervention; Opt-in Enrollment; Opt-out Enrollment; lottery; financial incentives
Retroclavicular Versus Coracoid Approach for Infraclavicular Brachial Plexus Block
Condition: Disorder of Upper Extremity
Study type: Interventional

Summary: 
      The primary aim of this study is to compare needle tip visibility between the coracoid
      approach and retroclavicular approach for infraclavicular brachial plexus block in patients
      undergoing elective upper limb surgery. Secondary aim is to investigate the differences
      between the two groups in the needle shaft visibility, sensorial block success rate, block
      performance time, block performance related pain, motor block success rate, surgical success
      rate, complications, patient satisfaction, use of supplemental local anesthetic, use of
      analgesic.
    

Detailed description: 
      Infraclavicular blocks are performed with different approaches. Infraclavicular block is
      usually traditionally performed at coracoid approach. Different approaches has been described
      for this block such as vertical approach. This study evaluated the effectiveness, safety and
      feasibility of a retroclavicular brachial plexus block as compared with traditionally
      coracoid approach for infraclavicular brachial plexus block. 100 patients scheduled for
      elective upper limb surgery were recruited and randomized into two groups: Coracoid approach
      for infraclavicular block (Group I), retroclavicular approach for infraclavicular block
      (Group R). Sensory block, adverse effects and complications were evaluated and recorded every
      10 minutes until 30min after local anesthetic injection.Success rate of each nerve sensory
      block, complications, rate of satisfaction, rate of failure and incidence rate of adverse
      effects, the needle tip and shaft visibility, procedure time,duration of the block's effect,
      use of supplemental local anesthetic, use of analgesic.are compared with both groups.
    

Intervention name(s): coracoid approach; retroclavicular approach
Intervention type(s): Other; Other
Intervention description(s): Coracoid approach for ultrasound guided infraclavicular brachial plexus block; retroclavicular approach for ultrasound guided infraclavicular brachial plexus block
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: retroclavicular approach; coracoid approach; ultrasound; upper limb surgery; needle visibility; infraclavicular brachial plexus block
Oxytocin and Social Cognition
Condition: Healthy Male Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine whether oxytocin influences memory of social
      stimuli and reaction to social stimuli. Furthermore the investigators explore the effect of
      oxytocin receptor (OXTR) polymorphism in terms of behavioral and neural responses to social
      stimuli.
    

Detailed description: 
      The prevailing view of OXT as a key facilitator of prosocial behaviors has been highly
      influenced by a plethora of studies in healthy volunteers, which demonstrated increased
      interpersonal trust, generosity, social learning/empathy and positively biased social
      stimulus processing as a result of OXT treatment. However, this interpretation is challenged
      by observations that OXT also promotes envy and schadenfreude (gloating), ethno-centrism
      (including prejudice, xenophobia, and racial bias), and defensive aggression towards
      outsiders.We investigate the neural correlates of emotion perception and subsequent memory
      effects of aversive and neutral stimuli. Tthe oxytocin effect on personal space is
      questioned. Additionally the effect of OXTR polymorphism regarding behavioral and neural
      response is explored.
    

Intervention name(s): Oxytocin
Intervention type(s): Drug
Intervention description(s): intranasal administration, 24 IU oxytocin; ; 3 puffs per nostril, each with 4 IU OXT
Other intervention name(s): Oxytocin: Syntocinon-Spray, Novartis
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: oxytocin; social cognition; fMRI; oxytocin receptor gene
To Investigate The Pharmacokinetics Of Intravenous WCK 5222 (FEP-ZID) In Patients With Renal Impairment
Condition: Renal Impairment
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, open label, single-dose, pharmacokinetic study to be conducted in male and
      female subjects with normal and impaired renal function. The study will be composed of five
      groups of patients with mild (6 patients), moderate (6 patients), severe (6 patients) renal
      impairment, end stage renal disease patients on hemodialysis (6 patients) and their
      respective matched controls in 1:1 ratio (24 healthy subjects with normal renal function).
      The severity of renal impairment will be assessed based on estimated creatinine clearance
      (CLCR) by the Cockcroft-Gault equation
    


Intervention name(s): WCK 5222
Intervention type(s): Drug
Intervention description(s): IV infusion over a period of 60 minutes
Other intervention name(s): Cefepime and zidebactam combination
Intervention MeSH terms: Cefepime; Cefepime-zidebactam
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Study Evaluating the Effect of ETX2514 on Cardiac Repolarization in Healthy Male or Female Volunteers
Condition: Acinetobacter Baumannii-calcoaceticus Complex Infections
MeSH terms: Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is being conducted to evaluate the effects of supratherapeutic ETX2514 plasma
      concentrations on the heart rate-corrected QT interval (QTc).
    


Intervention name(s): ETX2514; Placebo; moxifloxacin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): intravenous infusion; intravenous infusion; oral tablet
Intervention MeSH terms: Moxifloxacin; Durlobactam
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Acinetobacter baumannii-calcoaceticus; complex infections; ETX2514; cardiac repolarization; heart rate-corrected QT interval (QTc)
Pharmacokinetics of Doxycycline in Skin of Healthy Volunteers
Condition: Rosacea
MeSH terms: Rosacea
Study type: Interventional
Phase: Phase 1

Summary: 
      This study explored the impact of food on skin and plasma pharmacokinetics of doxycycline
    

Detailed description: 
      Sub-antimicrobial dose doxycycline is approved for the treatment of rosacea. This work
      investigated the pharmacokinetics of doxycycline in skin and plasma of fed and fasting
      healthy volunteers receiving a 14-day treatment course with once daily 40 mg doxycycline.
      Dermal measurements were performed by means of in vivo microdialysis.
    

Intervention name(s): Doxycycline
Intervention type(s): Drug
Intervention description(s): Doxycycline 40 mg capsules
Intervention MeSH terms: Doxycycline
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: parallel groups to compare outcomes between fed and fasting conditions
Masking: None (Open Label)
Primary purpose: Other
Keywords: pharmacokinetics; microdialysis; healthy volunteers