bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of Novel Point of Care Coagulation System in Pregnant Women
Condition: Hemorrhage; Coagulation Delay
MeSH terms: Hemorrhage
Study type: Interventional

Summary: 
      In this study the investigators will evaluate a new point of care Quantra Hemostasis Analyzer
      system to assess coagulation rapidly with ease.
    

Detailed description: 
      Unexpected bleeding continues to be an issue that confronts anesthesiologists. Obstetric
      bleeding spearheads as the leading cause of maternal mortality and morbidity. One of the
      hurdles that clinicians confront is a lack of point of care coagulation system that can
      hasten the clinical management strategy in the right direction. Conventional methods take
      considerable time to obtain results. TEG and ROTEM are currently doing the job however these
      two modalities requires expertise and proficient training to perform test and interpret
      results. The level of expertise to run the TEG and ROTEM poses hurdles for providing
      coagulation around the clock as it requires trained operators. What is currently required for
      efficient and effective management of obstetric hemorrhage is a point of care coagulation
      system in the operating room and or labor and delivery suite that is user friendly, easy and
      quick to perform. In this study the investigators will evaluate a new point of care Quantra
      Hemostasis Analyzer system to assess coagulation rapidly with ease.
    

Intervention name(s): Quantra Analyzer
Intervention type(s): Device
Intervention description(s): Subjects blood will be manipulated in the lab and will be tested with the Quantra Analyzer
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Modified Orbital Implantation Technique in Enucleation
Condition: Orbital Implants
Study type: Observational

Summary: 
      To assess the functional and cosmetic outcomes of enucleation with rectus end-to-end suturing
      surgical technique in hydroxyapatite orbital implants
    

Detailed description: 
      To assess the functional and cosmetic outcomes of enucleation with rectus end-to-end suturing
      surgical technique between 2005 and 2009. All the patients underwent primary enucleation and
      implantation of non-wrapped HA implants using a technique that involves drawing the ends of
      the rectus muscles anteriorly and suturing them into a cross-shape in front of the implant.
      Main outcome measures included occurrence of pain or discharge, soft tissue problems, implant
      motility, upper lid position, and patients' satisfaction.
    

Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The patients who had received hydroxyapatite orbital implants after primary enucleation by
        a single surgeon from July 2005 to March 2009
      
Biospecimen description: 
      The investigators reviewed surgical records from July 2005 to March 2009, to identify
      patients who had received hydroxyapatite orbital implants after primary enucleation by a
      single surgeon
The Prevalence and Characteristics of Adrenal Incidentaloma
Condition: Prevalence; Adrenal Incidentaloma
MeSH terms: Adrenocortical Adenoma; Adrenal Gland Neoplasms
Study type: Observational

Summary: 
      To investige the prevalence, characteristics and prognosis of adrenal incidentalomas in
      Chinese adults.
    

Detailed description: 
      With the development of imaging detection technology and its wide application in clinic, the
      detection rate of adrenal incidentaloma (AI) has been greatly improved. Most AI are benign
      and do not have the function of autonomic hormone secretion, but about 20% of them have
      function and can secrete adrenal hormone autonomously. Studies based on biopsy reports show
      that the prevalence of AI is about 2%, and the prevalence of AI detected by CT scan is 1% -
      4.5%. However, most of these studies are retrospective, and there may be selection bias and
      other confounding factors. There is no large sample prospective study on the prevalence of AI
      in the general population. The purpose of this study is to prospectively include patients
      with adrenal incidentaloma in community physical examination population, and evaluate their
      function and prognosis. The research results will provide new evidence for standardized
      diagnosis and treatment of adrenal incidentaloma in the future.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Chinese community adults
      
Biospecimen description: 
      Some subtye of disease should be diagnosed by DNA
    
Keywords: Prevalence; characteristics; adrenal incidentaloma
The Effect of Insect Protein on Performance and Hypertrophy
Condition: Protein Supplementation
MeSH terms: Hypertrophy
Study type: Interventional

Summary: 
      Purpose: to study the effect of insect protein on performance and hypertrophy during 8 weeks
      of resistance training.

      Hypothesis: Insect protein supplementation enhances the effect of resistance training on
      muscle mass and muscle strength.

      Primary outcome: Muscle hypertrophy and muscle strength

      Design: Two groups of healthy young men (age: 18-30 years) with resistance training
      experience, but no structural resistance training performed for the last 12 months.
      Randomized controlled intervention study +/- insect protein (placebo group ingest isocaloric
      carbohydrate). Both groups perform 8 weeks of progressive resistance training (4/week) aiming
      to induce muscle hypertrophy.
    


Intervention name(s): Protein supplementation; Resistance training
Intervention type(s): Dietary Supplement; Other
Intervention description(s): + insect protein; Resistance exercise
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Supplementation and Depressive Symptomatology Incidence Among Saudi Arabian Adults
Condition: Vitamin D Deficiency; Depressive Symptoms
MeSH terms: Vitamin D Deficiency; Depression
Study type: Interventional

Summary: 
      The goal of this randomized controlled trial is to explore the relationship between Vitamin D
      supplementation and depressive symptomatology in Saudi Arabian Population.

      The main questions it aims to answer are:

        -  Is Vitamin D deficiency associated with an increased prevalence of depressive
           symptomatology among Saudi Arabian Population?

        -  Is Vitamin D Supplementation for a period of 3-month at 50,000 International Units might
           be associated with an improved depressive status? All the participants were clients who
           attended the clinic to help with weight management - who were doing regular medical
           check-ups - at Al Themal Medical Center which is located in Abha, Saudi Arabia.

      Participants were requested to do a general blood test to check for any vitamins and minerals
      deficiencies as part of the routine clinical procedure. This procedure did not incur any
      additional costs on the behalf of the participants. The participants who were identified to
      have any deficiencies were recommended to take supplements, also as part of the routine
      clinical procedure. Therefore, participants identified to be deficient or insufficient
      Vitamin D levels were screened and recruited to participate in the current study.

      Participants were randomly assigned to either an interventional (vitamin D) or placebo group
      (control). The interventional group received vitamin D supplementation of 50.000International
      Units/week for 3 months and the placebo group received dietary advice and education on food
      sources of vitamin D for the same period. Both Groups received a weight gain or a weight loss
      diet as per their case.

      At the three-months follow-up, the participants were readministered the face-to-face
      questionnaire and their blood levels for vitamin D were also checked.

      Thus, this study would add value to the actions taken to treat vitamin D deficiency in Saudi
      Arabian adults. This might also assist in approaching new recommendations related to
      preventing or treating depression via vitamin D supplementation.
    


Intervention name(s): Vitamin D supplementation
Intervention type(s): Dietary Supplement
Intervention description(s): 50.000 IU of vitamin D supplementation was prescribed for deficient/insufficient participants for a 3 month period.
Intervention MeSH terms: Vitamin D
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Acamprosate Initiated During Alcohol Detoxification
Condition: Alcohol Use Disorder
MeSH terms: Alcoholism
Study type: Interventional
Phase: Phase 2

Summary: 
      Acamprosate is approved by the Food and Drug Administration (FDA) for the treatment of
      alcoholism. The purpose of this study is to see if initiating acamprosate early in alcohol
      detoxification instead of waiting until detoxification has been completed effects the course
      of detoxification, adverse events during detoxification, drop out rate during the
      rehabilitative treatment phase, or overall efficacy of acamprosate for those with alcohol
      dependence who plan to receive at least two months of rehabilitative pharmacotherapy with
      acamprosate.
    

Detailed description: 
      Biphasic clinical trial, consisting of a randomized, double-blind, placebo-controlled
      detoxification treatment phase (DP), followed by 9-week open-label rehabilitative treatment
      phase (RP).
    

Intervention name(s): Acamprosate; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 3 pills (666 mg) for 1998mg/day; 3 pills (666mg) for 1998mg/day
Other intervention name(s): Campral
Intervention MeSH terms: Acamprosate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: alcoholism
Shock Wave Therapy for Management of Spasticity in Patients With Cerebral Palsy
Condition: Cerebral Palsy; Spasticity, Muscle; Extracorporeal Shock Wave Therapy
MeSH terms: Muscle Spasticity; Cerebral Palsy; Shock
Study type: Interventional

Summary: 
      Spasticity is the most common motor disorder in cerebral palsy (CP). The objectives of his
      therapeutic approach include; reducing pain, ease of use of orthopedic aids, improving
      posture, minimizing contractures and deformity, and facilitating mobility and dexterity, with
      the ultimate goal of maximizing the potential of the patient and promoting their independence
      and quality of life. The approach to spasticity in CP is complex and presents itself as a
      great challenge for the rehabilitation team. Radial extracorporeal shock wave therapy (rESWT)
      has been established in recent years as an effective, non-invasive alternative with hardly
      any side effects (small bruises or discomfort during the application) for the management of
      spasticity in patients with CP. rESWT is a relatively new therapy in the field of neurology,
      in 2010 was published the first clinical trial where shock waves were applied for the
      management of spasticity in patients with CP. Currently, few works have studied the efficacy
      of rESWT in patients with CP. In all of them, the results demonstrated the treatment's
      effectiveness in reducing spasticity locally in people with CP up to 3 months after the
      application. The group most studied muscle has been the Triceps Surae, and there is a great
      disparity regarding the doses of treatment applied in each study, especially regarding the
      number of sessions and the time interval between sessions. The most widely used protocol is 3
      rESWT sessions with a time interval of 1 week between session; This protocol was established
      as the most effective in the treatment of trauma pathology. Despite all the variability in
      the administration of the dose, we have been able to observe that none of them has studied
      the effect of rESWT by lengthening the time interval between sessions beyond one week to
      check whether the therapeutic effects on spasticity can be prolonged over time by applying
      the same dose. Most of the studies conclude that future research should be aimed at studying
      the most optimal dose of treatment as well as evaluating the long-term results.
    


Intervention name(s): Radial extracorporeal shock wave therapy (rESWT)
Intervention type(s): Other
Intervention description(s): Radial shock waves are ballistic waves generated by injection of compressed air inside an applicator that fires a projectile into the itself and impacts against the application head
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Immunogenicity/Safety of Measles-Mumps-Rubella-Varicella Vaccine (MeMuRu-OKA): Using Two Different Administration Routes
Condition: Measles; Mumps; Rubella; Varicella
MeSH terms: Measles; Chickenpox; Herpes Zoster; Rubella
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will compare the immunogenicity and safety of the MeMuRu-OKA vaccine administered
      subcutaneously or using an alternative administration route.
    


Intervention name(s): MeMuRu-OKA (study vaccine)
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Practice Structure on Motor Learning in Post-Stroke Patients
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      Background: The literature indicates that, in relation to motor learning, healthy subjects
      benefit more from random practice than from constant practice. However, this effect is not
      well known in post-stroke patients. Objective: The goal of this study was to investigate the
      effects of practice structure on motor learning in post-stroke patients. Methods:
      Participants included an experimental group (EG) of post-stroke patients: 17 males and
      females; and a control group (CG) of healthy individuals: 17 males and females. At the
      acquisition phase, all participants performed 30 trials of a coincident timing task. Nine
      individuals from each group practiced constantly (C) at a stimulus propagation speed of 3
      mph, and eight from each group practiced randomly (R) at speeds of 2, 3, and 5 mph.
      Subsequent phases included: 1) transfer, 2) retention after 15 minutes, and 3) retention
      after 3 days. Each of these phases included 20 trials: 10 at a speed of 1 mph, and 10 at a
      speed of 4 mph. Intra- and inter-group comparisons were made employing an alpha level of 0.05
      (5%).
    

Detailed description: 
      Utilized was Bassin's anticipation timer (Lafayette Instruments #50575), which is comprised
      of a control screen, one 1.52 m gutter with 32 diodes placed on it linearly, and a response
      button. The screen has a digital display, with commands that permit the operator to control
      the stimulus propagation speed and the preparatory interval speed. Once activated, the screen
      exhibits an alert signal, and, after the preparatory interval, it initiates the propagation
      of a luminous stimulus, lighting the 32 diodes successively. The task required participants
      to press the response button simultaneously with the illumination of the last diode. The
      digital display showed the error measure (em): that is, the difference between the
      illumination of the last diode and the response.
    

Intervention name(s): Structure practice
Intervention type(s): Other
Intervention description(s): there were 2 groups which received random practice and constant practice during acquisition phase
Other intervention name(s): experimental group (EG); control group (CG)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: motor learning; hemiplegia; stroke; practice; physiotherapy
Functional Exercise Training With Adolescents With Cerebral Palsy
Condition: Cerebral Palsy
MeSH terms: Paralysis; Cerebral Palsy
Study type: Interventional

Summary: 
      This cross-over study analyzes a novel and inclusive approach in how therapy for adolescents
      with CP is administered, with the main goal of examining the effects of a functional exercise
      intervention on motor capability and motor capacity.

      It is to investigate the effects of a functional movement-based exercise intervention in a
      group setting on motor capacity, motor capability and quality of life in adolescents with CP
      compared to standard therapy.
    

Detailed description: 
      Cerebral palsy (CP) is a permanent disorder which affects the development of movement and
      posture. It causes activity limitation and is oftentimes accompanied by secondary
      musculoskeletal problems, disturbances of sensation, perception, cognition, communication and
      behavior.

      In regard of the complex interplay between physical restrictions, motor disabilities,
      sedentary lifestyles and low participation in physical activity, an innovative exercise
      intervention study for adolescents with CP is intended in order to break the stated vicious
      cycle. This study aims at providing a novel and inclusive approach in how therapy for
      adolescents with CP is administered, with the main goal of examining the effects of a
      functional exercise intervention on motor capability and motor capacity.
    

Intervention name(s): functional exercise training; standard therapy / treatment
Intervention type(s): Other; Other
Intervention description(s): 12 weeks functional exercise training twice per week, each session lasting 60 min; 12 weeks standard therapy / treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This study is designed as a two-armed crossover intervention study with two intervention phases lasting 12 weeks each and three measurement points.
Masking: None (Open Label)
Primary purpose: Other
Keywords: adolescents with cerebral palsy; functional exercise intervention; motor capability; motor capacity; gross motor function measure (GMFM-66)
Safety and Immunogenicity of Intradermal Versus Subcutaneous Doses of Menomune®
Condition: Meningococcal Infections; Meningitis
MeSH terms: Meningococcal Infections; Meningitis
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of this trial is to study the administration of the Menomune vaccine given
      intradermally and low-dose subcutaneously versus standard subcutaneously. This study will
      describe the immunogenicity of Menomune® - A/C/Y/W-135 administered subcutaneously (standard
      dose) versus intradermally over a dose range (1/10th, 2/10th, and 3/10th of standard dose)
      and a low dose (2/10th of standard dose) subcutaneously.

      The secondary objective is to describe the safety of the subcutaneous (SC) and intradermal
      (ID) routes at different dosages
    

Detailed description: 
      This trial will provide a proof of concept that a dose range of Menomune given ID can induce
      an immune response that is comparable to standard dosing by the SC route, and is equivalent
      or superior to a low dose given SC.

      Subjects will be randomized according to a computer-generated randomization schedule to
      receive the vaccine by SC injection or by ID injection at different dosages.
    

Intervention name(s): Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined; Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined; Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined; Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined; Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined
Intervention type(s): Biological; Biological; Biological; Biological; Biological
Intervention description(s): 0.5 mL, Subcutaneous; 0.1 mL, Subcutaneous; 0.05 mL, Intradermal; 0.1 mL, Intradermal; 0.15 mL, Intradermal
Other intervention name(s): Menomune® - A/C/Y/W-135; Menomune® - A/C/Y/W-135; Menomune® - A/C/Y/W-135; Menomune® - A/C/Y/W-135; Menomune® - A/C/Y/W-135
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Menomune® - A/C/Y/W-135; Meningococcal Infections; Meningitis
Cisplatin or Carboplatin Combined With Gemcitabine in Locally Advanced, Recurrent, or Metastatic Malignant Salivary Gland Tumor
Condition: Head and Neck Cancer
MeSH terms: Salivary Gland Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as cisplatin, carboplatin, and gemcitabine, work
      in different ways to stop tumor cells from dividing so they stop growing or die. Giving more
      than one drug may kill more tumor cells.

      PURPOSE: This phase II trial is studying how well giving gemcitabine together with either
      cisplatin or carboplatin works in treating patients with locally advanced, recurrent, or
      metastatic malignant salivary gland tumor (cancer).
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the activity of cisplatin or carboplatin in combination with gemcitabine, in
           terms of response rate, in patients with locally advanced, recurrent, or metastatic
           malignant salivary gland tumor.

      Secondary

        -  Determine the complete response in patients treated with these regimens.

        -  Determine the duration of response in patients treated with these regimens.

        -  Determine the toxicity profile of these regimens in these patients.

        -  Determine the overall survival of patients treated with these regimens.

      OUTLINE: This is a multicenter study.

      Patients receive gemcitabine IV over 30 minutes on days 1 and 8. Patients also receive either
      cisplatin IV over 1 hour on day 2 OR carboplatin IV over 30 minutes on day 1. Treatment
      repeats every 21 days for up to 6 courses in the absence of disease progression or
      unacceptable toxicity.

      Patients are followed at 4 weeks, every 3 months for 1 year, and then every 6 months
      thereafter until relapse.

      PROJECTED ACCRUAL: A total of 11- 34 patients will be accrued for this study within 1.5-3
      years.
    

Intervention name(s): carboplatin; cisplatin; gemcitabine hydrochloride
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Carboplatin; Gemcitabine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage II salivary gland cancer; stage III salivary gland cancer; stage IV salivary gland cancer; recurrent salivary gland cancer; salivary gland acinic cell tumor; salivary gland adenoid cystic carcinoma; salivary gland poorly differentiated carcinoma; high-grade salivary gland mucoepidermoid carcinoma; low-grade salivary gland mucoepidermoid carcinoma; salivary gland malignant mixed cell type tumor; salivary gland adenocarcinoma; salivary gland anaplastic carcinoma; salivary gland squamous cell carcinoma