bioihbjkbjnl/mcl2 huggingface dataset:
Vaginal Dinoprostone Versus Vaginal Misoprostol Prior to Diagnostic Office Hysteroscopy in Postmenopausal Patients
Condition: Office Hysteroscopy
Study type: Interventional
Phase: Phase 4

Summary: 
      To compare the effectiveness of vaginal dinoprostone and vaginal misoprostol with placebo in
      minimizing the pain experienced by postmenopausal patients during diagnostic ofﬁce
      hysteroscopy and to assess the ease of insertion of hysteroscope as reported by the
      hysteroscopist.
    

Detailed description: 
      hysteroscopy is commonly used in the diagnosis and treatment of intrauterine lesions such as
      polyps, ﬁbroids, septa, and adhesions, and in the presence of abnormal bleeding and during
      the removal of an intrauterine device or foreign body. Cervical ripening is made possible by
      the use of medication through different routes. The most commonly used agent is misoprostol,
      a synthetic prostaglandin E1 (PGE1) analog that is frequently administered in off-label use
      in obstetrics and gynecology for medical abortion, labor induction, endometrial biopsy,
      dilatation and curettage, intrauterine device insertion, myomectomy, postpartum hemorrhage,
      and cervical ripening. In contrast, dinoprostone, a natural PGE2, is mostly used in
      obstetrics for cervical ripening and the stimulation of uterine contractions to induce labor.
    

Intervention name(s): Dinoprostone; Misoprostol; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 1 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia & Upjohn, Puurs, Belgium) inserted by the patient 12 hours before the scheduled office hysteroscopy.; Misoprostol (200µg) will be administered vaginally 12 hours before office hysteroscopy.; one tablet of placebo inserted by the patient 12 hours before the scheduled office hysteroscopy.
Intervention MeSH terms: Misoprostol; Dinoprostone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effectiveness of Soft Tissue Mobilization
Condition: Tension-Type Headache
MeSH terms: Tension-Type Headache; Headache
Study type: Interventional

Summary: 
      The aim of this study was to determine the effects of soft tissue mobilization and trigger
      point release verses stretching in tension-type headache among university students. Two
      randomized groups of participants with tension type headache will be treated with combination
      therapy of soft tissue mobilization and trigger point release therapy after the application
      of hot-pack in experimental group while control group received stretching of cervical muscles
      after hot-pack application .Both, male and female patients meeting the inclusion criteria
      will be included. Patients having malignancy and cervical tumor will be excluded.
    

Detailed description: 
      It was a Randomized Control Trial Study. Study setting was Bashir Institute of Health
      sciences. Inclusion Criteria was Age 18 to 25 year's students, with tension type headache and
      trigger point in neck muscles. 30 Subjects were randomly and equally allocated to
      experimental group (n=15) and control group (n=15) through toss and coin method. Outcomes
      include cervical range of motions were measured by Goniometer and VAS for paini.e., used at
      baseline and at the final session for duration of 3 weeks.
    

Intervention name(s): cervical stretching; soft tissue mobilization
Intervention type(s): Other; Other
Intervention description(s): Heating therapy for 10 minutes Passive stretching of neck muscles including Sub-occipital muscles, Trapezius upper boarder and Sternocleidomastoid muscle with 10 reps each; Heating therapy for 10 minutes Soft tissue mobilization for 8 minutes and trigger point release of sub-occiptal muscles with 5 repetitions each.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: RCT
Masking: Single (Participant)
Primary purpose: Treatment
Comparison of Enteral Products for Tube Fed Patients With Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      To compare the glucose response in tube fed subjects with type 2 diabetes of a standard
      enteral product to that of a diabetes-specific enteral product
    


Intervention name(s): standard enteral feeding product; Diabetes specific feeding product
Intervention type(s): Other; Other
Intervention description(s): 16 hrs daily x 5 days; 16 hrs daily for 5 days
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Treatment of Covid-19 Associated Pneumonia With Allogenic Pooled Olfactory Mucosa-derived Mesenchymal Stem Cells
Condition: COVID; Covid-19; Coronavirus; Pneumonia; Pneumonia, Viral; Pneumonia, Interstitial; Sars-CoV2
MeSH terms: COVID-19; Pneumonia; Pneumonia, Viral; Lung Diseases, Interstitial
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Treatment of patients with Covid-19 associated pneumonia using intravenous injection of
      allogenic pooled olfactory mucosa-derived mesenchymal stem cells
    

Detailed description: 
      During the implementation of the project, it is planned to develop a method for the treatment
      of severe covid-19 associated interstitial pneumonia using allogeneic mesenchymal stem cells.
      The positive outlook for the effectiveness of MSCs is due to the following:

        -  knowledge of the leading role of immunopathogenetic mechanisms in the development of
           acute interstitial lung diseases and the pronounced immunomodulating properties of MSCs;

        -  high tropism of MSCs to lung tissue when administered intravenously;

        -  the ability of MSCs to stimulate tissue regeneration and the effective use of MSCs in
           the treatment of acute damage to the myocardium and kidneys, which will contribute to
           the treatment of multiple organ failure;

        -  positive results of preclinical studies of the method of treatment of viral pneumonia in
           animals, and the first clinical studies in patients.
    

Intervention name(s): Allogenic pooled olfactory mucosa-derived mesenchymal stem cells; Standard treatment according to the Clinical protocols
Intervention type(s): Biological; Other
Intervention description(s): Allogenic pooled olfactory mucosa-derived mesenchymal stem cells; Standard treatment according to the Clinical protocols
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pneumonia; Sars-COV2; Covid-19
Single Ascending Dose Study of Intravenous TRV130A in Healthy Adult Males
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the safety, blood levels, and effects of TRV130A on pain perception
      and sedation in healthy adult males.
    


Intervention name(s): TRV130A; Dextrose in Water
Intervention type(s): Drug; Drug
Intervention description(s): Intravenous infusion of 1 hour duration; Intravenous infusion of 1 hour duration
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: safety; tolerability; TRV130A
Responding to Children and Adolescents With Tyrannical Behaviour
Condition: Oppositional Defiant Disorder
MeSH terms: Attention Deficit and Disruptive Behavior Disorders
Study type: Observational

Summary: 
      This was a randomized controlled trial that compared the NVR intervention group with a TAU
      group during a four-months period in reducing stress in parents of children aged 6-20 years
      and displaying severe tyrannical behaviour (STB).
    


Intervention name(s): Non-Violent Resistance parental training
Intervention type(s): Behavioral
Intervention description(s): Non-Violent Resistance parental training
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Parents of children with STB aged 6-20 years old
      
Biospecimen description: 
      NC
    
Keywords: Child-To-Parent Violence; Severe tyrannical behaviour; NVR; parental training program
The Effect of Dietary Salt Intake on Immune Function in Patients With Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      The purpose of this work is to investigate the influence of dietary salt intake on immune
      function in multiple sclerosis (MS) subjects and healthy controls. This study primarily tests
      the hypothesis that higher dietary salt intake will be associated with a higher frequency of
      pathogenic Th17 cells and impaired function of protective regulatory T cells. If a
      relationship between dietary salt intake and immune function is observed, this study will
      also test: a) whether this relationship is unique to MS subjects or whether it is also
      present in healthy controls, and b) whether healthier immune function can be restored by
      restricting dietary salt intake.
    

Detailed description: 
      The purpose of this work is to investigate the influence of dietary salt intake on immune
      function in MS subjects and healthy controls. This study primarily tests the hypothesis that
      higher dietary salt intake will be associated with a higher frequency of pathogenic Th17
      cells and impaired function of protective regulatory T cells. If a relationship between
      dietary salt intake and immune function is observed, this study will also test: a) whether
      this relationship is unique to MS subjects or whether it is also present in healthy controls,
      and b) whether healthier immune function can be restored by restricting dietary salt intake.
      This is a 5-week pilot study of a dietary intervention of 25 subjects with MS or Clinically
      Isolated Syndrome (CIS) by 2010 Diagnostic Criteria who will be identified and recruited from
      the Yale MS Center and/or referred from outside MS centers. 25 age-matched healthy controls
      will be recruited from friends, family members, spouses and the patient waiting room at the
      Yale MS Center.
    

Intervention name(s): High/Low Sodium Diet
Intervention type(s): Dietary Supplement
Intervention description(s): All patients will receive 2 weeks of the high sodium diet followed by a 1 week washout and then 2 weeks of the low sodium diet
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: High Sodium Diet; Low Sodium Diet; MS
Patient Preference in Blood Pressure Therapy
Condition: Arterial Hypertension
MeSH terms: Hypertension
Study type: Observational

Summary: 
      Written surveys of patients with high blood pressure are designed to determine how they would
      likely decide if, in addition to taking medication, they had another option to treat their
      hypertension.

      The alternative treatment option is renal sympathetic denervation using catheter ablation.
      This new treatment method is not yet used in the standard care. Currently, studies are being
      conducted in specific centers to demonstrate the efficacy of this treatment.

      Questionnaires are used to determine the preference of patients for one or the other option
      of hypertension treatment. So far, there are no findings.
    


Observational model: Ecologic or Community
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        -  male and female

          -  > 18 years
      
Keywords: Hypertension; renal denervation; preference; shared decision making
Preoperative Etanercept Before Inguinal Hernia Surgery
Condition: Inguinal Hernia; Postoperative Pain
MeSH terms: Pain, Postoperative; Hernia; Hernia, Inguinal
Study type: Interventional

Summary: 
      Inguinal hernia repair is one of the most frequently performed operations in young men.
      Persistent pain after inguinal surgery represents a significant cause of disability,
      occurring in between 15%-35% of cases. In a majority of these patients, their groin pain
      persisted after a previous hernia repair. The main type of chronic postsurgical pain is
      neuropathic, caused by injured nerves. One of the principal components in the pathophysiology
      of postsurgical pain is cytokines, specifically tumor necrosis factor (TNF). In animal
      studies, injecting TNF inhibitors before nerve injury can reduce pain behaviors and
      neuropathology. Finding a way to reduce the incidence of postsurgical pain after hernia
      repair could enhance function, and reduce the need for opioids and other analgesics. The
      investigators intend to conduct the first randomized, controlled study evaluating whether
      preemptive administration of a tumor necrosis inhibitor can reduce postoperative pain and
      opioid consumption after hernia repair. This is important because the degree and intensity of
      postsurgical pain is a major predictor for the development of chronic postsurgical pain.
    

Detailed description: 
      76 patients with an inguinal hernia scheduled for surgical repair will be randomized in a 1:1
      ratio to receive either subcutaneous etanercept or saline before skin incision. The study
      will be double-blind (i.e. neither the surgeon, anesthesiologist, nor the person
      administering the injection will know which group they were assigned to). Group I will
      receive 50 mg of subcutaneous etanercept mixed in 1 ml sterile water 90-120" before skin
      incision. Group II will receive 1 ml of sterile water 90-120" before skin incision. The
      anesthesia and surgical procedures will be standardized. For the next 24 hours, patients will
      keep a q4 hour pain diary recording their average pain on a 0-10 numerical rating scale. They
      will also record the number of Percocet tablets they took. All patients will be seen 1 month
      after their surgery, where their average pain score, work status, and analgesic intake (if
      any) will be recorded. Patients will then be followed with a telephone follow-up 3, 6 and
      12-months post-procedure, where the same variables will be recorded.
    

Intervention name(s): Etanercept; Saline
Intervention type(s): Drug; Drug
Intervention description(s): 50 mg subcutaenous preoperatively; Given subcutaneously preoperatively
Intervention MeSH terms: Etanercept
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: postoperative pain; inguinal hernia; chronic postsurgical pain; cytokine; preemptive analgesia; patients with inguinal hernia scheduled for surgery
A Clinical Trial to Study the Safety, Tolerance and Immunogenic Response to MCV4, Tdap and Bivalent rLP2086 Vaccine When Given at the Same Time to Children Between the Ages of 10 Through 12 Years of Age
Condition: Vaccines; Meningococcal Vaccines
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a clinical study to assess the safety, tolerance and immunogenic response to
      MCV4(quadrivalent meningococcal polysaccharide conjugate, meningococcal serogroups A,C,Y, and
      W135), Tdap (diphtheria, tetanus, and acellular pertussis), and bivalent rLP2086 vaccine.
      Healthy male and female subjects, between the ages of 10 to 12 years old, will be randomized
      into 1 of 3 groups. The subjects, investigators, site staff and sponsor will be blinded to
      all injections given throughout the study. An unblinded administrator will be responsible to
      administer the vaccinations to all subjects and will be unblinded to the subject
      randomization in order to determine which subjects were in randomized to group 3 so they may
      receive their catch-up vaccinations of MCV4 and Tdap. A final telephone contact will be
      conducted with all subjects 6-months post their last vaccination to obtain safety
      information.
    


Intervention name(s): rLP2086 + MCV4 + Tdap; MCV4 + Tdap + saline; rLP2086 + saline
Intervention type(s): Biological; Biological; Biological
Intervention description(s): At visit 1, group 1 will receive MCV4 + Tdap vaccines concomitantly with an injection of rLP2086. At visits 3 and 5 (Months 2 and 6), group 1 will receive an injection of rLP2086.; At visit 1, group 2 will receive MCV4 + Tdap vaccines concomitantly with an injection of saline. At visits 3 and 5 (months 2 and 6), this group will receive a saline injection only.; At visit 1, group 3 will receive 2 injections of saline concomitantly with an injection of rLP2086. At visits 3 and 5 (Months 2 and 6), group 3 will receive an injection of rLP2086. Subjects randomized to this group will receive MCV4 and Tdap following their final visit blood draw (Visit 6).
Allocation: Randomized
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: vaccine; rLP2086; MCV4; Tdap; meningitis B; N. meningitidis serogroup B; adolescents; observer-blind
Psychometric Properties of IntelliSpace Cognition
Condition: Cognitive Functioning of Healthy Individuals
Study type: Interventional

Summary: 
      This study aims to validate the tests that are on the IntelliSpace Cognition platform and to
      establish normative data for these tests.
    


Intervention name(s): IntelliSpace Cognition (ISC); Paper-Pencil Tests
Intervention type(s): Device; Diagnostic Test
Intervention description(s): Philips ISC is a Class-II Medical Device in the US and provides objective data regarding cognition via scoring algorithms that HCPs can use to inform diagnostic decision making and treatment planning. It enables tracking cognition over time and offers the possibility of new outcome measures. ISC can be used in a variety of healthcare environments such as neurology and neuropsychology practices.; The same cognitive tests that are on the ISC platform are performed using paper and pencil (rather than digitally) as is the case in standard clinical practice.
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: cognitive model; cognitive assessment; digital cognitive tests; automated scoring; algorithms
A Mobile Intervention to Improve Uptake of PrEP for Southern Black MSM
Condition: Hiv
Study type: Interventional

Summary: 
      This study will develop and test an interactive mobile messaging intervention to improve
      engagement in care related to Pre-exposure Prophylaxis (PrEP) and decrease HIV risk behaviors
      for Black men who have sex with men living in the Southern U.S. The mobile messaging
      intervention will include interactive text messaging and free, publicly available links to
      websites and YouTube videos. During the intervention participants will gain information about
      their health, improve motivation for engagement in PrEP related care, and build skills for
      healthy behaviors. Participants will also receive intervention materials to help decrease
      frequent barriers to care. If the intervention is found to be effective, it can be tested in
      a larger study and then disseminated.
    

Detailed description: 
      The uptake of Pre-Exposure Prophylaxis (PrEP) has been slow for young Black men who have sex
      with men (BMSM) living in the Southern United States. This is a significant issue because
      eight of the ten states with the highest rates of new HIV infections are located in the
      South. Jackson, Mississippi (MS) (the site of this project) has the second highest AIDS
      diagnosis rate in the nation, and the highest rate of HIV infection for young urban Black men
      who have sex with men. This study will develop and test an engaging, interactive, and cost
      effective mobile messaging intervention to improve linkage to PrEP care for BMSM (18-35 yrs)
      living in Jackson, MS. BMSM eligible for PrEP, receiving care at the University of
      Mississippi Medical Center sexually-transmitted infections (STI)/HIV testing clinics, will be
      texted interactive links to publicly available, online content about PrEP and HIV prevention.
      Links will be sent to PrEP eligible BMSM by 8-16 interactive text messages over 4 weeks. The
      material used in the intervention will be consistent with the Information Motivation Behavior
      (IMB) Model and will address cultural and structural barriers to initiating PrEP care. A
      small randomized controlled study among 66 new participants in the clinics will examine the
      preliminary efficacy of the intervention compared to enhanced standard of care on attendance
      at a PrEP Services Appointment (the first step in initiating PrEP care). It is hypothesized
      that, compared to BMSM receiving enhanced standard of care, BMSM receiving the PrEP Mobile
      Messaging Intervention will show greater attendance at a PrEP Services Appointment and
      decreased HIV risk behavior at 4 and 16 weeks.
    

Intervention name(s): PrEP Mobile Messaging Intervention; Enhanced Standard of Care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): See group description; See group description
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: PrEP; Uptake; MSM; Black
Study Evaluating LXR-623 in Healthy Japanese Adults
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety of LXR-623 in healthy Japanese subjects.
    


Intervention name(s): LXR-623
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment