bioihbjkbjnl/mcl2 huggingface dataset:
Study of the Safety and Contraceptive Efficacy of C31G Compared to Conceptrol®
Condition: Pregnancy
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multicenter, randomized, double-masked, controlled, phase III study of repeated use
      of C31G vaginal gel compared to Conceptrol® Vaginal Gel as the primary method of
      contraception over six months (183 days) and at least six cycles of use. In addition, there
      is an opportunity for subjects to continue with study treatment for up to twelve months (365
      days) and twelve cycles of treatment upon completion of the first six months of treatment.
    

Detailed description: 
      Approximately 85% of American women (52 million) between the ages of 15 and 44 are sexually
      active . Approximately two-thirds or 38 million women use some form of birth control and/or
      STD prevention. With growing awareness of the risk of STDs, increasing numbers of women will
      require contraceptive methods that provide protection against STDs in addition to providing
      the basic contraceptive function. Currently there is no single, reasonably effective method
      to achieve both ends. Condoms, both male and female, present problems of acceptability for
      the partners of many at-risk women and, thus, cannot be considered an effective contraceptive
      and STD preventive for many people. A spermicide that also has the ability to prevent
      transmission of STDs would be a major advance, and of tremendous value to women worldwide.

      C31G is an effective spermicide with in vitro activity equal to that of N-9 . C31G has been
      found to be a broad-spectrum antibacterial agent in vitro or in animals, active against both
      gram-positive and gram-negative organisms, including chlamydia, and a range of antibiotic
      resistant strains. It is also active against enveloped viruses including HIV and HSV. Thus,
      the primary objective of the study is to determine the contraceptive efficacy of C31G vaginal
      gel compared to Conceptrol® Vaginal Gel. The secondary objectives are to determine the safety
      and acceptability of the compounds with use over a period of six months or twelve months.
      Additional evaluations include the incidence of urinary tract infections (UTI), bacterial
      vaginosis (BV) and yeast vaginitis following the use of C31G vaginal gel compared to
      Conceptrol® Vaginal Gel.
    

Intervention name(s): C31G; nonoxynol-9 (N-9)
Intervention type(s): Drug; Drug
Intervention description(s): The subject will insert one applicator of C31G prior to each episode of vaginal intercourse during her participation in the study.; The subject will insert one applicator of Conceptrol® vaginal gel (nonoxynol-9) prior to each episode of vaginal intercourse during her participation in the study.
Intervention MeSH terms: Nonoxynol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: contraception
Levita Magnetic Grasper Device Safety and Performance Study
Condition: Benign Gallbladder Disease
MeSH terms: Gallbladder Diseases
Study type: Interventional

Summary: 
      The purpose of this study is to determine the Levita Magnetic Grasper Device Safety and
      Performance in Laparoscopy.
    


Intervention name(s): Use of Levita Magnetics Grasper
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Lower Protein Intake and Long-term Risk of Obesity and Cardiovascular Disease
Condition: Infant Formula; Growth
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      The primary objective of this study is to investigate if consumption of lower protein formula
      can slow the rate of weight gain of formula-fed infants between 3 and 12 months of age.
      Secondary objectives include investigation into whether infant nutrition and growth have an
      impact on later risk of obesity and cardiovascular disease.
    

Detailed description: 
      Obesity and its cardiovascular consequences are the most important causes of morbidity and
      mortality worldwide. Breastfed infants have been shown to have less cardiovascular risk
      factors in adulthood, which can be partially explained by their slower growth compared to
      formula fed infants. The primary objective of this study is to investigate if consumption of
      lower protein formula can slow the rate of weight gain of formula-fed infants between 3 and
      12 months of age. Secondary objectives include investigation into whether infant nutrition
      and growth have an impact on later risk of obesity and atherosclerotic cardiovascular disease
      (CVD), the critical windows for these programming effects, and the mechanisms of action.
    

Intervention name(s): Modified infant formula; Standard infant formula
Intervention type(s): Other; Other
Intervention description(s): Test formula with lower protein content than standard formula; Standard infant formula
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective, randomized, double-blind with nonrandomized breast-fed reference group
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Protein requirements; Adiposity; Body composition; Cardiovascular health
Efficacy and Safety of Ularitide for the Treatment of Acute Decompensated Heart Failure
Condition: Acute Decompensated Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of a continuous intravenous
      (IV) ularitide infusion on the clinical status and outcome of patients with acute
      decompensated heart failure (ADHF).
    

Detailed description: 
      The objective of the TRUE-AHF study is to evaluate the effect of a 48-h continuous IV
      infusion of ularitide (15 ng/kg/min) versus placebo on the clinical status of patients with
      acute decompensated heart failure (ADHF).

      The study drug will be administered in addition to the standard treatment. The nature of
      standard therapy will be carried out according to the clinical judgment of the Investigator
      and may include vasodilator, inotropic, and diuretic drugs, as clinically indicated.

      There are two co-primary endpoints for this study. Co-primary endpoint 1 will be a
      hierarchical clinical composite variable that includes a patient-centered assessment of
      clinical progress, an assessment of lack of improvement or worsening of HF requiring a
      pre-specified intervention, and death.

      The endpoint is intended to mimic the assessment that would be carried out by a physician
      caring for the patient. If, during the 48 h infusion, a patient's clinical course
      deteriorates because he/she dies, fails to improve or develops worsening HF requiring a
      pre-specified intervention or if the patient considers his/her general clinical status as
      moderately or markedly worse, the patient will be considered to be "worse". If the patient
      considers his/her general clinical status as moderately or markedly improved and if such
      improvement is sustained without fulfilling the criteria for "worse" throughout the 48-h
      infusion (from 0 h to 48 h), the patient will be considered to be "improved". If the patient
      is neither improved nor worse, the patient's clinical status will be considered to be
      "unchanged".

      Co-primary efficacy endpoint 2 evaluates freedom from cardiovascular mortality during follow
      up after randomization, for the entire duration of the trial.
    

Intervention name(s): Ularitide; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Ularitide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Acute decompensated heart failure
PRP in Recurrent Implantation Failure
Condition: Recurrent Implantation Failure
MeSH terms: Recurrence
Study type: Interventional

Summary: 
      The endometrial function and endometrial receptivity have been accepted to be major limiting
      factors in the establishment of pregnancy. In spite of improved almost all aspects of IVF:
      ovarian stimulation, embryo culture and transfer, the pregnancy rates still not satisfactory.
      The bottleneck is the process of implantation.

      Recurrent implantation failure (RIF) is one of the nightmares in reproductive medicine and
      despite several strategies that have been described for management; there is no universal
      agreement yet.

      Recently, intrauterine infusion of platelet-rich plasma (PRP) is described to promote
      endometrial growth and receptivity, PRP has been investigated as a therapeutic approach for
      several medical disorders in dermatology and rheumatology, but its use in IVF is still
      limited.

      Objective:

      To evaluate the effectiveness of intrauterine perfusion of autologous platelet-rich plasma in
      the improvement of pregnancy rate in RIF patients.
    

Detailed description: 
      After ethical committee approval was obtained, 150 infertile women with history of RIF gave
      their written consent to be included in this study. All were recruited from the outpatient
      clinic of Al-Baraka fertility hospital - with age below 40 yrs, body mass index (BMI) below
      30 kg/m2, whose uteri were morphologically normal as confirmed by HSG and U/S to limit
      additional factors that may affect the results of the study - Divided into 2 comparable
      groups; all participants underwent antagonist protocol, oocytes retrieval, fertilization and
      embryo transfer; In the study group, intrauterine infusion of 0.5 to 1 ml of platelet-rich
      plasma (PRP) was performed 48 hrs before blastocyst transfer, pregnancy tests were done 12
      days after ET.
    

Intervention name(s): PRP
Intervention type(s): Procedure
Intervention description(s): Platelet Rich Plasma
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Recurrent implantation failure; implantation; IVF; platelet rich plasma (PRP)
A Study to Evaluate the Tolerability and Pharmacokinetics of Two Single and Multiple High Dose Regimens of BIA 2-093 In Healthy Volunteers
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional
Phase: Phase 1

Summary: 
      Single centre, double-blind, randomised, placebo-controlled study of two dosage regimens of
      BIA 2-093 - 1800 mg (Group 1) and 2400 mg (Group 2) - in two groups of healthy male
      volunteers
    

Detailed description: 
      Within each group (n=9) 3 volunteers were randomised to receive placebo and the remaining 6
      volunteers to receive BIA 2-093. No volunteer was a member of more than one treatment group.
      In each group, the study consisted of a single-dose period (Phase A) followed by a 7-day
      multiple-dose period (Phase B). The multiple-dose phase started 96 h post single-dose.
      Progression to the 2400 mg dose (Group 2) only occurred if the 1800 mg dose (Group 1) was
      considered to be safe and well tolerated. An appropriate interval separated the investigation
      of the two groups in order to permit a timely review and evaluation of safety data.

      Treatment consisted of a single-dose (Phase A) followed by a once-daily dose for 7 days
      (Phase B). Doses were prepared as follows: Group 1 = 3 tablets of BIA 2-093 600 mg plus 1
      placebo tablet, or 4 placebo tablets; Group 2 = 4 tablets of BIA 2-093 600 mg, or 4 placebo
      tablets.
    

Intervention name(s): BIA 2-093 - 1800 mg (Group 1); BIA 2-093 - 2400 mg (Group 2); Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 3 tablets of BIA 2-093; 4 tablets of BIA 2-093 600 mg; placebo tablets
Other intervention name(s): Eslicarbazepine acetate; Eslicarbazepine acetate; sugar pills
Intervention MeSH terms: Eslicarbazepine acetate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Anticonvulsant
NOX-E36 Multiple Ascending Dose Study in Healthy Volunteers and Patients With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The primary objective of this trial is to evaluate the safety and tolerability of multiple
      intravenous doses of NOX-E36 in healthy subjects and patients with type 2 diabetes mellitus.
      A secondary objective of the trial is to obtain exploratory estimates of the pharmacodynamic
      response at the level of inflammation, metabolism as well as ongoing diabetes complications
      (e.g. impaired cardiovascular, liver and renal function). Thus, the study is designed to
      provide sufficient safety and dose-response data for a planned Phase IIa proof of concept
      study with NOX-E36 in patients with multiple complications of type II diabetes mellitus.
    


Intervention name(s): NOX-E36; NOX-E36
Intervention type(s): Drug; Drug
Intervention description(s): Multiple dose 0.25 mg/kg or placebo i.v. to healthy volunteers; dosing frequency q2d; Multiple dose of 0.0625 mg/kg, 0.125 mg/kg, 0.25 mg/kg or placebo i.v. to patients with type 2 diabetes mellitus (ratio 3:1); dosing frequency q2d
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study to Compare Methodologies for Assessing Glucose-Dependent Insulin Secretion (0000-104)(COMPLETED)
Condition: The Methodology Assessment of Glucose Dependent Insulin Secretion
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will compare graded glucose infusion (GGI) to the hyperglycemic clamp (HGC) for
      assessment of glucose-dependent insulin secretion (GDIS) using exenatide as a probe.
    


Intervention name(s): Comparator: exenatide; Comparator: exenatide; Comparator: Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): exenatide in two 5mcg subcutaneous doses 120 minutes apart, followed by either HGC or GGI. After a 14 day washout period two additional 5mcg doses will be administered, followed by HCG or GGI.; exenatide in two 1.5mcg subcutaneous doses 120 minutes apart, followed by either HGC or GGI. After a 14 day washout period two additional 1.5mcg doses will be administered, followed by HCG or GGI.; 5% osmitrol in two 60 mcL subcutaneous doses 120 minutes apart, followed by either HGC or GGI. After a 14 day washout period two additional 60 mcL doses will be administered, followed by HCG or GGI.
Other intervention name(s): Byetta; Byetta
Intervention MeSH terms: Exenatide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Diagnostic
A Placebo-controlled Study for SPM 962 in Early Parkinson's Disease Patients
Condition: Early Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      To investigate superiority of SPM 962 over placebo in early Parkinson's disease patients in a
      multi-center, placebo-controlled, double-blind study following once-daily multiple
      transdermal doses of SPM 962 within a range of 4.5 to 36.0 mg (12-week dose
      titration/maintenance period)
    


Intervention name(s): SPM 962; placebo
Intervention type(s): Drug; Drug
Intervention description(s): transdermal application, 1 time per day; transdermal application, 1 time per day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: SPM 962; rotigotine; Parkinson's disease; monotherapy
Sympatholytic Effect of Thoracic ESP
Condition: Pain, Chronic
MeSH terms: Chronic Pain
Study type: Interventional

Summary: 
      The primary endpoint of this study was to identify if erector spinae plane bloock (ESPB)
      demonstrates any sympatholytic effect.

      The secondary endpoint of this study was to compare the changes of PI value between
      responders and non-responders.
    

Detailed description: 
      The erector spinae plane block (ESPB) is a less invasive, safer, and technically easy
      alternative procedure to conventional neuraxial anesthetic techniques. In contrast to common
      neuraxial techniques such as paravertebral and epidural injections, the ESPB targets an
      interfascial plane which is far from the spinal cord, root, and pleura. First applied to
      thoracic neuropathic pain, currently ESPB is being applied to postoperative pain control and
      includes variable clinical situations. In the abdomen and thoracic wall, thoracic ESPB can be
      applied for pain control after cardiac surgery, video-assisted thoracic surgery, laparoscopic
      cholecystectomy, and thoracotomy. Recently, favorable postoperative pain control after lumbar
      spinal or lower limb surgeries has been reported with lumbar ESPB. In addition, ESPB has also
      been used for chronic pain conditions in the upper and lower extremities. The perfusion index
      (PI) is a numerical value for the ratio between pulsatile and non-pulsatile blood flow
      measured by a special pulse oximeter. Although the special probe for PI measurement is
      relatively more expensive compared with ordinary pulse oximetery probes, its benefit as a
      marker of peripheral perfusion and as an idex for sympathetic stimulation have increased its
      use progressively.

      ESPB can achieve analgesic effect by blocking the ventral and doramal ramus and possibly by
      diffusion into paravertebral space. In constrast to lumar region, thoracic paravertebral
      space is very close to the sympathetic chain. Therefore, sympatholytic effect might be
      achieved by thoracic ESPB. No previous study has demonstrated the sympatholytic effect of
      ESPB.
    

Intervention name(s): Erector spinae plane block
Intervention type(s): Procedure
Intervention description(s): fascial plane injection guided by ultrasound
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Topiramate in the Treatment of Posttraumatic Stress Disorder in Civilians
Condition: Post-Traumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective of this study is to investigate the safety and efficacy of topiramate
      in the treatment of PTSD in women survivors of domestic violence and/or rape trauma as
      measured by the Clinician-Administered PTSD Scale (CAPS) for DSM-IV.
    

Detailed description: 
      Psychopharmacologic treatment of PTSD has been informed by only limited empirical data. Prior
      to the recently completed multi-site trials for sertraline conducted by Pearlstein and
      colleagues which found efficacy for women but not men suffering from chronic PTSD, there were
      only a handful of published randomized controlled trials. An overview of this literature
      suggests that tricyclic antidepressants, monoamine inhibitors and selective seratonin
      reuptake inhibitors (SSRIs) show promise, usually with better responses in civilians with
      PTSD than in male veterans with combat-related PTSD. Although results from open-label studies
      of alpha-2 agonists, beta blockers, anticonvulsants, and mood stabilizing agents appear to be
      promising, at present no one agent has emerged as useful for a broad range of PTSD sufferers.

      This is a single-center, outpatient, randomized, double-blind, placebo-controlled, parallel
      group study designed to evaluate the safety and efficacy of topiramate in treating PTSD in
      civilian trauma. This study will be conducted in up to 60 subjects with a diagnosis of PTSD
      as defined by DSM-IV criteria. Thirty subjects will be assigned to topiramate and 30 will be
      assigned to placebo.
    

Intervention name(s): Topiramate
Intervention type(s): Drug
Intervention MeSH terms: Topiramate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: PTSD; trauma
Non-Invasive Assessment of Contact Lens Performance During Use of a Digital Display
Condition: Visual Acuity
Study type: Interventional

Summary: 
      This is a two-arm, open-label, bilateral dispensing clinical investigation. Eligible subjects
      will proceed to either a low-sphere or high-sphere arm based on refraction measurements in
      the baseline assessment.
    


Intervention name(s): JJVC Marketed Contact Lens
Intervention type(s): Device
Intervention description(s): Acuvue Oasys® 1-Day
Other intervention name(s): Test 1
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
Clinical Trial Assessing the GNbAC1 in Patients With Onset of Type 1 Diabetes Within 4 Years
Condition: Diabetes Mellitus Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2

Summary: 
      The monoclonal antibody GNbAC1 targets the envelope protein (Env) of the human endogenous
      Multiple Sclerosis associated RetroVirus (MSRV), which could play a critical role in
      different autoimmune disorders, notably type 1 diabetes (T1D).

      This study is a multicentre study evaluating for the first time the safety and efficacy of
      GNbAC1 in T1D subjects for a first bouble-blind period of 20 weeks followed by an optional
      open-label period of 24 weeks. The primary objective of the study is to assess the safety and
      tolerability of six consecutive 4-weekly doses of GNbAC1 in subjects with T1D. Secondary
      objectives are to determine the pharmacodynamic response to GNbAC1 on biomarkers of T1D.
    


Intervention name(s): GNbAC1; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Monthly IV repeated dose; Monthly IV repeated dose
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The first part of the trial is double-blind and the second part is open-label with all participants receiving the active treatment.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Diabetes Mellitus, Type 1; T1D; Monoclonal antibody; Multiple Sclerosis associated retrovirus MSRV; Human Endogenous Retrovirus Type W (HERV-W); GNbAC1; Temelimab