bioihbjkbjnl/mcl2 huggingface dataset:
Testing the Safety and Preliminary Efficacy of the New Drug ORY-2001 in Mild to Moderate Alzheimer's Disease
Condition: Mild to Moderate Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase IIa study assessing the safety, tolerability and preliminary efficacy of
      ORY-2001 in mild to moderate Alzheimer's Disease patients.
    

Detailed description: 
      This phase IIa study is a double-blind, randomized, parallel-group and multicenter study with
      a placebo-controlled 24-week treatment period followed by a no placebo-controlled 24-week
      extension period.

      It is planned to randomise 25 patients. In the double-blind placebo-controlled treatment
      period, all patients will be randomized between two doses of ORY-2001 and placebo. In the
      double-blind no placebo-controlled extension period, patients in the placebo arm will be
      re-allocated in one of the two different dose levels of ORY-2001. Randomization will be
      stratified by cognitive impairment severity.

      An independent Data Monitoring Committee (DMC) will review un-blinded safety data throughout
      the study.
    

Intervention name(s): ORY-2001 Low dose; ORY-2001 High dose; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 0.6mg ORY-2001 capsule; 1.2mg ORY-2001 capsule; Placebo capsule
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Alzheimer's Disease, ORY-2001
Effect of Thermal Stimulation on Cortical Excitability and Motor Function in Chronic Stroke Patients
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Functional magnetic resonance imaging (fMRI) has confirmed that thermal stimulation (TS) may
      facilitate cortical excitability in healthy adults. However, it is unknown whether TS can
      increase cortical excitability in stroke patients. Compared to the fMRI, the transcranial
      magnetic stimulation (TMS) possesses more concise conditions in temporal resolution, and it
      can present the cerebrum activation situation more instantaneously. This study aimed to use
      TMS examining the effect on corticomotor excitability, reorganization and functional motor
      recovery after TS on affected upper limbs of chronic stroke patients.
    

Detailed description: 
      The study was an assessor-blinded randomized controlled clinical trial. The participants
      (more than 3 months posts-stroke)were randomly assigned to experiment (EXP) and control (COT)
      groups. All participants received regular conventional rehabilitation programs. The EXP and
      COT received additional upper extremity TS protocol for 30 minutes a day for 20 days. The TS
      temperature of EXP for noxious stimulation was set at 46-47°C for heat and 7-8°C for cold
      stimulation; the temperature of COT for innoxious stimulation was set at 40°C for warm and
      20°C for cold stimulation. The motor and sensory performance were evaluated at baseline and
      post-20th- TS by Brunnstrom's recovery stage, Modified Ashworth Scale (MAS), Barthel Index
      (BI), Upper Extremity Subscale of the Fugl-Meyer Motor Function Assessment (UE-FM) and
      Thermal Quantitative Sensory Testing (tQST). At pre-1st-TS, post-1st-TS, post-10th-TS and
      post-20th-TS, focal TMS was used to obtain measurement of motor threshold (MT), motor evoked
      potentials (MEPs), size of cortical motor output map and location of the amplitude-weighted
      centre of gravity of the motor output map (CoG) from abductor pollicis brevis (APB) in
      bilateral upper extremities.
    

Intervention name(s): Thermal stimulation system
Intervention type(s): Device
Intervention description(s): The subjects meeting our criteria will be randomly assigned to either the experimental group (EXP) or the control group (COT). The EXP and COT received upper extremity thermal stimulation protocol for 30 minutes a day for 20 days. The TS temperature of EXP for noxious stimulation was set at 46-47°C for heat and 7-8°C for cold stimulation; the temperature of COT for innoxious stimulation was set at 40°C for warm and 20°C for cold stimulation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Stroke; Thermal Stimulation; Upper Extremity; Motor Recovery; Transcranial Magnetic Stimulation
Activation of the Sphingosine-1-phosphate (S1P) to S1P1 Receptor Subtype (S1PR1) Axis in Patients With Endometriosis: Identification of Potential Relevant Biomarkers to Diagnose and Treat
Condition: Endometriosis
MeSH terms: Endometriosis
Study type: Observational

Summary: 
      Patients seen at the SLUCare Center for Endometriosis (including those with or without pain)
      undergoing laser excision surgery for known or suspected endometriosis will be recruited for
      the study.

      Per the PI's standard surgical approach to endometriosis, all areas of abnormal peritoneum
      will be excised (removed).

      After surgical excision has been performed, in order to provide standardized specimens for
      our research, a 3mm punch biopsy will be obtained from the excised peritoneum tissue. The 3
      mm biopsy will be sent for research analysis, and the rest of the excised peritoneum tissue
      will be sent to histology (SSM) for evaluation and classification as having endometriosis or
      not. For each patient in the study, blood will also be collected to look for markers for
      endometriosis.
    

Detailed description: 
      The study is investigator-initiated, prospective, comparative study. Laparoscopic surgery for
      endometriosis on patients presenting with pain, infertility or both will be performed by the
      principal investigator at St. Mary's Hospital. We will be collecting preoperative, operative
      and postoperative follow-up data on all patients recruited for this study based on
      comprehensive preoperative questionnaires, which includes data collection on pain scores (by
      VAS scales) and standardized QOL scales, and the 6-12 month follow questionnaire. The
      surgical approach in the treatment of endometriosis is by excision only, so that all lesions
      (abnormal areas of peritoneum) are excised resulting in tissue specimens that are classified
      at a histologic level, which is the gold standard way to diagnose the presence of
      endometriosis.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients seen at the Center for Endometriosis (including those with or without pain)
        undergoing laser excision surgery for known or suspected endometriosis will be recruited
        for the study.
      
Biospecimen description: 
      Per the PI's standard surgical approach to endometriosis, all areas of abnormal peritoneum
      will be excised (removed).

      After surgical excision has been performed, in order to provide standardized specimens for
      our research, a 3mm punch biopsy will be obtained from the excised peritoneum tissue. The 3
      mm biopsy will be sent for research analysis, and the rest of the excised peritoneum tissue
      will be sent to histology (SSM) for evaluation and classification as having endometriosis or
      not. For each patient in the study, blood will also be collected to look for markers for
      endometriosis.
Type of Exercise and Education in Patients With SubAcromial Pain Syndrome
Condition: Shoulder Pain
MeSH terms: Shoulder Pain
Study type: Interventional

Summary: 
      Patients seeking care for shoulder pain will be recruited to enroll will be randomized to one
      of four combined treatment groups; eccentric or traditional strengthening alone and eccentric
      or traditional strengthening with pain neuroscience education. Patients will be followed for
      1 year.
    

Detailed description: 
      Patients seeking care for their shoulder in a primary care setting will be recruited to
      participate in a trial investigating the value of different exercise and education regimens.
      Patients that choose to participate will be randomized to 1 of 4 different treatment groups
      focused on strengthening of the rotator cuff and shoulder girdle muscles: eccentric
      strengthening alone; traditional strengthening alone; eccentric strengthening plus education
      focused on pain neuroscience, traditional strengthening plus education focused on pain
      neuroscience. All patients will be seen in the clinic for 4-6 sessions over a 4-week period,
      as well receive a home exercise program that aligns with the exercise group there were
      randomized to.

      One-year outcomes will be compared across all 4 groups.
    

Intervention name(s): Eccentric Strengthening; Traditional Strengthening; Pain education
Intervention type(s): Procedure; Procedure; Behavioral
Intervention description(s): Use of eccentric strengthening exercises in treatment plan during visits and at home.; Use of traditional strengthening exercises in treatment plan during visits and at home.; Addition of pain neuroscience-focused education in addition to strengthening exercise program
Other intervention name(s): Pain Neuroscience Education; Therapeutic Neuroscience Education
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Exercise; Pain Neuroscience Education; Physical Therapy; Subacromial Pain; Rotator Cuff
Effect of S-ketamine in Cesarean Section Combined Anesthesia
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      To compare the anti-hyperalgesia effect between S-ketamine with placebo for Maternal
      receiving elective Cesarean Section under Combined spinal and epidural analgesia.

      Based on this study the investigators intend to verify the role and potential mechanism of
      S-ketamine combined anesthesia in alleviating hyperalgesia after cesarean section, prove that
      it can reduce hyperalgesia and postoperative pain. explore the role of S-ketamine in
      alleviating postoperative hyperalgesia in different PCA ways and explore the safety of
      S-ketamine in the perilactation
    


Intervention name(s): S-ketamine
Intervention type(s): Drug
Intervention description(s): S-ketamine or placebo were given to the fetus after delivery Patient-controlled intravenous analgesia or patient-controlled epidural analgesia were administered postoperatively
Other intervention name(s): Patient controlled analgesia
Intervention MeSH terms: Ketamine; Esketamine
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: According to different groups, s-ketamine and placebo were given respectively According to the different PCA methods, different subgroups were included
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: S-ketamine; Cesarean Section; hyperalgesia
A Phase 2 Study to Evaluate the Dose and Pharmacodynamic Efficacy of Sialic Acid-Extended Release (SA-ER) Tablets in Patients With GNE Myopathy or Hereditary Inclusion Body Myopathy
Condition: GNE Myopathy; Hereditary Inclusion Body Myopathy
MeSH terms: Muscular Diseases; Distal Myopathies
Study type: Interventional
Phase: Phase 2

Summary: 
      GNE myopathy or hereditary inclusion body myopathy (HIBM) is a severe progressive metabolic
      myopathy caused by a defect in the biosynthetic pathway for sialic acid (SA).
    

Detailed description: 
      GNE myopathy or hereditary inclusion body myopathy (HIBM) is a severe progressive metabolic
      myopathy caused by a defect in the biosynthetic pathway for sialic acid (SA). Substrate
      replacement therapy is a potential therapeutic strategy based on the success of replacing
      missing SA and reducing muscle disease in a relevant mouse model of the human disease
      (Malicdan et al., 2009). Successful use of SA replacement therapy in humans is believed to
      depend upon providing steady long-term exposure to the compound in an extended release form
      (such as Sialic Acid-Extended Release [SA-ER]), given SA's short half-life. Following a Phase
      1 study to establish the pharmacokinetics (PK) for SA-ER, Ultragenyx is conducting this study
      to assess the dose and potential pharmacodynamic effect of restoring sialylation of muscle by
      treatment with SA-ER at two dose levels as compared to placebo when administered over two 24
      week periods of time. The study will also evaluate safety, as well as the effect of SA-ER on
      clinical measures of muscle strength, mobility, function and self-reported disability and
      quality of life. Effects on muscle volume/mass and function and on serum biomarkers will be
      evaluated as exploratory measures. These data should allow the selection of a dose and the
      appropriate design for a Phase 3 clinical study.
    

Intervention name(s): Sialic Acid Extended Release (SA-ER); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): SA-ER will be administered in doses of 3000mg per day or 6000mg per day; Subjects will be randomized to the placebo arm for the first 24 weeks of the study. Then, subjects in this arm will be re-randomized into either the 3,000 mg per day or 6,000 mg per day arm for the remaining 24 weeks of the study (total study duration 48 weeks).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hereditary Inclusion Body Myopathy (HIBM); GNE myopathies; distal myopathy with rimmed vacuoles [DMRV]; Nonaka disease
Efficacy and Safety of Vortioxetine (Lu AA21004) in the Treatment of Patients With Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the efficacy and safety of vortioxetine, once daily
      (QD), in adults with major depressive disorder.
    

Detailed description: 
      The drug that was tested in this study is called Vortioxetine. Vortioxetine is being tested
      to treat depression in adults who have major depressive disorder (MDD). This study looked at
      MDD relief in people who took varying dosages of vortioxetine.

      The study enrolled 611 patients. Participants were randomly assigned (by chance, like
      flipping a coin) to one of the four treatment groups-which remained undisclosed to the
      patient and study doctor during the study (unless there was an urgent medical need):

        -  Vortioxetine 2.5 mg

        -  Vortioxetine 5 mg

        -  Duloxetine 10 mg

        -  Placebo (dummy inactive capsule) - this was a capsule that looked like the study drug
           but had no active ingredient.

      All participants were asked to take one capsule at the same time each day throughout the
      study.

      This multi-center trial was conducted in the United States. The overall time to participate
      in this study was up to 12 weeks. Participants made 8 visits to the clinic, and were
      contacted by telephone 4 weeks after the last dose of study drug for a follow-up assessment.
    

Intervention name(s): Vortioxetine; Duloxetine; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Encapsulated vortioxetine immediate-release tablets; Duloxetine capsules; Placebo-matching capsules
Other intervention name(s): Lu AA21004; Brintellix®; Cymbalta®
Intervention MeSH terms: Duloxetine Hydrochloride; Vortioxetine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Major Depressive Disorder; Depression; Drug Therapy; Major Depressive Episode
Xylitol Adult Caries Trial (X-ACT)
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the trial is to determine the extent to which daily use of xylitol lozenges
      reduces the appearance of new caries lesions in adults who tend to experience such lesions
      (i.e., caries-active adults).
    

Detailed description: 
      Dental caries incidence is higher in adults than children. Recent recommendations from both
      the Centers for Disease Control and an NIH Consensus Development Conference on dental caries
      call for clinical trials of caries prevention methods in caries-active adults. Little is
      known about the effectiveness of caries prevention methods in adults, and virtually no
      information exists with respect to prevention among adults who are at elevated risk for
      developing caries lesions. This application describes a clinical trial of an intervention to
      prevent dental caries in caries-active adults that is responsive to the CDC and Consensus
      Conference recommendations.

      The Xylitol for Adult Caries Trial (X-ACT) is a three-year, multi-center, randomized,
      placebo-controlled, double-blind study to determine the effectiveness of xylitol lozenges in
      reducing the incidence of coronal and root caries in caries-active adults. The intervention
      is the daily use of xylitol lozenges. Participants will be 750 adults (ages 25-75) with
      current or recent caries lesions who are dental school patients at one of three Clinical
      Centers in Chapel Hill, NC, Birmingham, AL, and San Antonio TX. These Clinical Centers offer
      diverse populations with substantial proportions of minority populations that enhance the
      generalizability of the findings. The Study Chair is located at the University of North
      Carolina-Chapel Hill, and the Data Coordinating Center is at the Kaiser Permanente Center for
      Health Research in Portland, OR.

      This intervention is being tested because it represents a potentially effective caries
      prevention method with a high likelihood of adoption by dental practitioners as an "add on"
      caries preventive method for their caries-active patients. The potential for adoption of the
      intervention is an important consideration because current data suggest that caries-active
      adults are underexposed to caries-preventive treatment in dental practices. If effective, the
      intervention also holds potential as a public health measure.
    

Intervention name(s): xylitol; inactive lozenge
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 1g xylitol lozenges to be dissolved in mouth. Five lozenges daily for three years; 1g inactive lozenge, dissolved in mouth. Five/day for three years
Other intervention name(s): placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Swim up and Gradient Methods Used in Assisted Reproduction Techniques on DNA Fragmentation of Spermatozoa
Condition: Male Infertility; Unexplained Infertility
MeSH terms: Infertility; Infertility, Male
Study type: Interventional

Summary: 
      Sperms are prepared by sperm washing techniques before used in assisted reproductive
      technologies. Most commonly used sperm preparation methods are the swim up and the density
      gradient. Recent studies shows that the DNA integrity status of the spermatozoa is related to
      the success in assisted reproduction techniques. Sperm preparation methods may theoretically
      cause damage to sperm DNA. Therefore it is important to select the optimum method of sperm
      preparation causing least sperm DNA damage. Aim of our study is to investigate and compare
      the effect two different sperm preparation techniques on DNA fragmentation.
    


Intervention name(s): swim-up, density gradient sperm preparation techniques
Intervention type(s): Procedure
Intervention description(s): Sperms are prepared by sperm washing techniques before used in assisted reproductive technologies. Most commonly used sperm preparation methods are the swim up and the density gradient. Recent studies shows that the DNA integrity status of the spermatozoa is related to the success in assisted reproduction techniques. Sperm preparation methods may theoretically cause damage sperm DNA. Therefore it is important to select the optimum method of sperm preparation causing least sperm DNA damage. Aim of our study is to investigate and compare the effect two different sperm preparation techniques on DNA fragmentation.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Spermatozoa; DNA fragmentation; Swim-up; Density gradient
A Study to Evaluate a Quality Improvement Intervention to Reduce Wound Separation Rates in Obese Gynecologic Oncology Service Patients Undergoing Abdominal Surgery
Condition: Wound Complications; Wound Infection; Wound Separation
MeSH terms: Wound Infection; Wounds and Injuries
Study type: Interventional
Phase: Phase 2

Summary: 
      Approximately 500,000 surgical site infections occur annually in the US. These lead to worse
      patient quality of life, more outpatient and emergency room visits, readmissions and home
      services, with an estimated increase in costs of at least $3500 per complication. Surgical
      site infections are associated with increasing body mass index. There is limited and
      conflicting data of the utility of multiple surgical interventions to decrease the risk of
      surgical site complications. The investigators explored the effect of a prospective care
      pathway for closure of vertical abdominal wounds on patient's wound complications.
    


Intervention name(s): Prospective wound complication protocol
Intervention type(s): Procedure
Intervention description(s): The skin and subcutaneous tissues were incised using a scalpel or cutting electrocautery. Use of coagulation current on the skin or subcutaneous tissues was not allowed, except focally to attain hemostasis. At the conclusion of surgery, a 7mm Jackson-Pratt drain was placed below Camper's fascia, which in turn was closed with 3-0 plain catgut suture. The skin was closed with staples. Dressings were retained for at least twenty-four hours. Staples were to be retained for at least two weeks.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Wound complications; Wound infection; Wound separation