bioihbjkbjnl/mcl2 huggingface dataset:
Safety, Tolerability,Pharmacokinetics(PK)and Pharmacodynamics(PD)Assessment of LCQ908 in Patients With Severe Hypertriglyceridemia
Condition: Hyperlipoproteinemia
MeSH terms: Hypertriglyceridemia; Hyperlipoproteinemias; Hyperlipidemias
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study will assess safety, tolerability, and effect of LCQ908 on blood lipids in patients
      with severe hypertriglyceridemia.
    


Intervention name(s): LCQ908; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Familial hyperchylomicronemia; Lipoprotein lipase deficiency; Hyperlipoproteinemia; Triglycerides; Hypertriglyceridemia; LCQ908; Hyperlipoproteinemia associated with lipoprotein lipase deficiency
A Mobile Phone App to Promote Healthy Diet and Physical Activity in 2.5-year-olds
Condition: Obesity, Childhood
MeSH terms: Pediatric Obesity
Study type: Interventional

Summary: 
      Childhood obesity is still a major global health issue. The preschool age (2-5 years) has
      been identified as a critical period to intervene, Mobile technology (mHealth) has been
      successful for weight loss and behavior changes in adults. This proposed randomized
      controlled trial aims to assess the effectiveness of an 6-month intervention program, the
      Mobile-based intervention to stop obesity in preschoolers (MINISTOP) 2.0 mobile phone app
      integrated in primary child health care for parents of children aged 2.5 years. The MINISTOP
      2.0 app is built on the previous MINISTOP 1.0 app. Five hundred children will be recruited at
      their routine visit at 2.5 years of age and after baseline measures randomized to the
      intervention or control group. In addition, the investigators will assess acceptability,
      feasibility and appropriateness of the app by parents and primary child health care nurses.
    


Intervention name(s): MINISTOP 2.0
Intervention type(s): Behavioral
Intervention description(s): The MINISTOP 2.0 is a behavioural change program aiming to promote healthier diet and physical activity among 2.5-year-old children. The program consists of features such as information, monitoring and feedback (dietary key variables, physical activity, screen time) and it is built around 13 themes during the 6-month period.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
A Study To Examine The Effects Of PF-04958242 On Ketamine-Induced Cognitive Impairment In Healthy Volunteers
Condition: Schizophrenia
MeSH terms: Schizophrenia; Cognitive Dysfunction
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess if PF-04958242 can attenuate the ketamine-induced cognitive impairment in verbal
      learning and memory, episodic memory and spatial working memory in healthy volunteers.
    

Detailed description: 
      This study was previously posted by Pfizer, Inc. Sponsorship of the trial was transferred to
      Biogen.
    

Intervention name(s): PF-04958242; Ketamine; Placebo; Ketamine
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): PF-04958242, 0.35 mg orally administered capsule on Day 1 and 0.25 mg orally administered capsule on Days 2 - 5; At 60 minutes after the 0.25 mg dose of PF-04958242 on Day 5, Ketamine (0.23 mg/kg over 1 minute, followed by a maintenance rate of 0.58 mg/kg/hr for 75 minutes) will be infused.; Placebo capsule orally administered on Days 1 - 5; At 60 minutes after Placebo on Day 5, Ketamine (0.23 mg/kg over 1 minute, followed by a maintenance rate of 0.58 mg/kg/hr for 75 minutes) will be infused.
Intervention MeSH terms: Ketamine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: PF-04958242; ketamine; cognition; healthy volunteers
Promoting HPV Vaccine Through Twitter
Condition: Human Papilloma Virus
MeSH terms: Papilloma
Study type: Observational

Summary: 
      This study assessed the feasibility of implementing a one-month Twitter campaign to promote
      knowledge about the human papillomavirus (HPV) vaccine among low-income women living in
      public housing.
    

Detailed description: 
      Investigators recruited a convenience sample (n=35) of women ages 18-26 years who resided in
      public housing in Massachusetts. Investigators assessed the feasibility and acceptability of
      the campaign. Online assessed changes in HPV knowledge, attitudes, and vaccine intentions
      before and after the campaign.
    

Intervention name(s): Twitter
Intervention type(s): Behavioral
Intervention description(s): Participants received a daily tweet over a period of one-month with educational messages about HPV vaccine and cervical cancer
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women residing in public housing Ages18-26 years No history of cervical cancer
      
Keywords: vaccination; feasibility; public housing
Retroseptal Transconjunctival Blepharoplasty for GIR
Condition: Eyelid Diseases
MeSH terms: Eyelid Diseases
Study type: Interventional

Summary: 
      The tear trough deformity is a challenging cosmetic condition.surgical treatment and filling
      are good treatment options
    

Detailed description: 
      Procedure is lower eyelid transconjunctival Blepharoplasty associated with stromal vascular
      fraction gel (SVF-gel) or fat transposition
    

Intervention name(s): transconjunctival lower blepharoplasty
Intervention type(s): Procedure
Intervention description(s): transconjunctival lower blepharoplasty associated with stromal vascular fraction gel (SVF-gel)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: tear trough, blepharoplasty,orbital fat
Study of Resiniferatoxin for Knee Pain in Moderate to Severe Osteoarthritis
Condition: Osteoarthritis, Knee; Pain, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 1

Summary: 
      This study evaluates the safety of resiniferatoxin in patients with moderate to severe knee
      pain due to osteoarthritis.
    

Detailed description: 
      This study is to evaluate the safety of resiniferatoxin administered intra-articularly to
      subjects with moderate to severe knee pain due to osteoarthritis (OA). It is also to assess
      the preliminary efficacy of resiniferatoxin to relieve knee pain when walking.
    

Intervention name(s): Resiniferatoxin; Saline
Intervention type(s): Drug; Drug
Intervention description(s): Resiniferatoxin is a compound purified from natural sources.; Saline is a normal physiological solution
Other intervention name(s): RTX; Normal saline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effects of Neuro-myo-electrical Stimulation on Insulin Sensitivity in Patients With Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Type 2 diabetes is a major public health problem because of its increasing prevalence and
      morbidity and mortality that accompanies it. Therapeutic management of this pathology,
      lifestyle measures, dietary and physical activity are fundamental. Their observance is
      unfortunately too often insufficient, leading to a therapeutic climbing with first oral
      antidiabetic (OAD) then the use of insulin therapy.

      Yet there is now ample evidence that physical activity improves glucose control in these
      patients in particular improving insulin sensitivity after a training period but also after a
      single session of physical activity.

      Neuro-myo-electrical stimulation (NMES) is used in common clinical practice in physical
      therapy, patients with neurological or after orthopedic surgery in particular. In fact, this
      method enables improvement of volume and strength, even for denervated muscles. Recent
      studies have also shown the benefits of NMES in situations of cardiac or respiratory
      readjustments. In addition, NMES is used by top athletes supplements classical training in
      order to develop muscle strength or speed recovery.

      Investigators propose to test the impact of bilateral quadriceps NMES on insulin sensitivity
      in type 2 diabetic patients treated with OAD (excluding glitazone). To do this, investigators
      plan to assess their insulin sensitivity by the reference method of hyperinsulinemic
      euglycemic clamp before surgery, after a single session of bilateral quadriceps NMES and
      after a sequence of daily training 6 days a quadriceps NMES bilateral.

      Investigators hope to show an improvement in insulin sensitivity by this method, which would
      constitute an alternative to physical activity in the treatment of diabetes type 2. This
      procedure would be particularly interesting in diabetic subjects with type 2 counter-
      indications or an inability to perform a conventional physical activity.
    


Intervention name(s): acute muscle exercise by NMES; daily workout sequence with NMES in one week; rest situation
Intervention type(s): Device; Device; Other
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparison of Regional Block, Wound Infiltration and Caudal Block for Pain Management in Children
Condition: Inguinal Hernia
MeSH terms: Hernia, Inguinal
Study type: Interventional

Summary: 
      Comparison of regional block, wound infiltration and caudal block for post operative pain
      management in participants undergoing inguinal herniotomy.
    

Detailed description: 
      Investigators are comparing three modalities (regional block, wound infiltration and caudal
      block), for post operative pain management in participants after inguinal herniotomy.
    

Intervention name(s): Regional block; Wound infiltration; Caudal block
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): regional block with 0.25% Bupivacaine at a dose of 2ml/kg with adrenaline; Infiltration of surgical site with 0.25% Bupivacaine at 0.5ml/kg dose; Infiltration of caudal epidural space with 0.25% Bupivacaine at 1ml/kg dose
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Global Postural Reeducation and Segmental Exercises in Patients With Scapular Dyskinesis and Cervicalgia
Condition: Scapular Dyskinesis; Cervicalgia
MeSH terms: Dyskinesias; Neck Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the effectiveness of global postural reeducation
      relative to segmental exercises in the treatment of scapular dyskinesis with cervicalgia.
    

Detailed description: 
      Purpose: To assess the effectiveness of global postural reeducation relative to segmental
      exercises in the treatment of scapular dyskinesis with cervicalgia.

      Methods: Participants with scapular dyskinesis and cervicalgia (n = 30) aged 18 to 65 years
      were randomly assigned to one of two groups: Global Postural Reeducation and Segmental
      Exercises(stretching and strengthening). Upper extremity was assessed using the Disabilities
      of the Arm, Shoulder and Hand (DASH) questionnaire. Function of the neck was estimated using
      the Neck Disability Index (NDI). Pain severity was measured using a Visual Analogical Scale.
      Health-related quality of life (HRQoL) was assessed using the Short Form (SF)-12. Assessments
      were conducted at baseline and after 10 weekly sessions (60 minutes each). Significance level
      was established at 5%.
    

Intervention name(s): Global Postural Reeducation Group; Segmental Exercises Group
Intervention type(s): Other; Other
Intervention description(s): Sessions happened once a week for 10 weeks, lasting 60 minutes each and consisted in manual therapy maneuvers and global postural reeducation treatment.; Sessions happened once a week for 10 weeks, lasting 60 minutes each and consisted in segmental exercises (stretching and strengthening) treatment.
Other intervention name(s): Global Postural Reeducation; Stretching Exercises; Segmental Exercises; Stretching and Strengthening Exercises
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Physical Therapy Modalities; Posture; Muscle Stretching Exercises; Dyskinesias; Neck pain
Exchangeable Zinc Pool Size and Zn Absorption From Sprinkles and Traditional Foods in Pakistani Infants /Toddlers
Condition: Malnutrition
MeSH terms: Malnutrition
Study type: Observational

Summary: 
      The broad objective is to improve zinc status in older infants and young children who are at
      risk of zinc deficiency because of combination of inadequate dietary zinc intake and high
      rates of diarrhea. As a sub-study within larger RCT using zinc fortified Sprinkles, the
      proposed study will measure the amount of zinc absorbed from a test meal of typical
      unfortified complementary foods consumed by Pakistani infants, or the same complementary
      foods fortified by the addition of the Zn-containing Sprinkle.
    

Detailed description: 
      In the nested study we aim to measure from a subgroup of recruited children in the main
      study, the amount of zinc absorbed from typical unfortified complementary foods consumed by
      Pakistani infants, and compare it with the same complementary food fortified by the addition
      of the Zn-containing Sprinkles and multi vitamins. Since EZP Exchangeable Zinc Pool is
      considered to be the gold standard for estimation of the actual concentration of zinc in the
      plasma that is readily available for cellular function, we would also calculate the EZP in
      this subset of samples.

      The specific aim of the nested study will :

        1. Determine absorption of zinc (Zn) from a test meal consisting of typical local food with
           addition of a multiple-micronutrient Sprinkles product containing (10 mg of Zn) vs
           absorption from the same meal without zinc supplementation to those with no
           micronutrient fortification.

        2. Compare size of exchangeable Zn pool (EZP) for subjects who have been randomized to
           receive multi-micronutrient Sprinkle (MN) only with those who were randomized to (MN+Zn
           ) with control group.

        3. Children will be followed for growth monitoring for at least 2 years.

        4. Plasma zinc and phytates levels in the weaning diet will also be assessed.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Infants between the ages of 9 and 12 months
      
Keywords: zinc; zn; EZP (exchangeable zinc pools)multivitamin MN
Laparoscopic Ovarian Cystectomy Versus Aspiration and Coagulation in Ovarian Endometrioma
Condition: Ovarian Endometrioma
MeSH terms: Endometriosis
Study type: Interventional

Summary: 
      The aim of this study is to evaluate the impact of laparoscopic ovarian cystectomy versus
      aspiration and coagulation on ovarian reserve and pelvic pain in cases of ovarian
      endometrioma.
    

Detailed description: 
      All patients are presenting with ovarian endometrioma. They are all subjected to informed
      written consent, full history, general examination, local examination and transvaginal
      ultrasound. Follicular stimulating hormone (FSH), Lutenizing hormone (LH), Anti Mullerian
      hormone (AMH), Antral follicular count (AFC) and chronic pelvic pain which is assessed by
      Visual Analogue Scale (VAS) of pain scoring system ,all are to be determined before and after
      laparoscopic surgery (postoperative three months); for two groups (Group A) cystectomy and
      (Group B) aspiration and coagulation. Histopathological examination was done to the
      cystectomy group to confirm endometriosis and detect the presence of healthy ovarian tissue
      in the excised cyst wall.
    

Intervention name(s): ovarian cystectomy; ovarian cyst aspiration and coagulation
Intervention type(s): Procedure; Procedure
Intervention description(s): laparoscopic ovarian cystectomy in endometrioma; laparoscopic ovarian cyst aspiration and coagulation in endometrioma
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
Keywords: Endometrioma; laparoscopy; ovarian reserve; pelvic pain
Free Nonvascularized Fibula Autograft for Tumor-like Lesions in Femoral Neck Using in Pediatric Patients
Condition: Bone Diseases
MeSH terms: Bone Diseases
Study type: Interventional

Summary: 
      This study was to evaluate the safety and efficacy of free nonvascularized fibula autograft
      in the treatment of the femoral neck tumor-like lesions before epiphyseal closure in
      pediatric patients, by presenting the clinic-radiological outcome and complications.
    


Intervention name(s): free nonvascularized fibula autograft
Intervention type(s): Procedure
Intervention description(s): Sixteen pediatric patients before epiphyseal closure were treated with free nonvascularized fibula autograft after resections of tumor-like lesions in the femoral neck between Aug. 2012 and Sep. 2016. All the patients were given supplementary skeletal traction through supracondyle of femur for 4 weeks to 6 weeks after the resections.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
An Bioequivalence Study Comparing Nicergoline 10 mg Tablet Manufactured in China With Nicergoline 10 mg Tablet Manufactured in Italy Under Fasted and Fed Conditions in Healthy Chinese Participants
Condition: Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is a bioequivalence study to support a generic consistency evaluation program,
      initiated by the China Food and Drug Administration (CFDA) in 2015, for the evaluation of
      quality and efficacy of the products manufactured in China. Related guidance was issued by
      Center for Drug Evaluation (CDE) on 27 Nov 2015 named "Use pharmacokinetic (PK) parameter as
      endpoint for chemical generics bioequivalence (BE) study".

      Nicergoline localized product is manufactured at Pfizer Dalian China, while the reference
      product is manufactured at Pfizer Italia S.r.l., Italy. The selected strength of 10 mg tablet
      is the marketed strength in China, and the selected dose of 30 mg (3 x 10 mg tablet) is one
      of the commonly used clinically approved daily doses with good tolerability profile.

      In each group, participants will be randomized to one of the 2 treatment sequences according
      to a computer generated randomization schedule. Each treatment sequence will consist of 2
      periods, separated by a washout period of at least 7 days between the first day of each
      period.
    


Intervention name(s): Nicergoline from China; Nicergoline from Italy
Intervention type(s): Drug; Drug
Intervention description(s): This is the test arm of China local manufactured Nicergoline; This is the reference arm of Italy originator Nicergoline.
Intervention MeSH terms: Nicergoline
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Pharmacokinetics
Study Combining Imatinib Mesylate (Gleevec) With Sorafenib in Patients With Androgen-independent Prostate Cancer (AIPC)
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      Eligible patients will be enrolled in one of 4 cohorts where each cohort will allow 3
      patients to be on study. Patients will receive both study drugs on escalated dosing schedule
      until the maximum of 400 mg PO BID is reached for both drugs or toxicity is established. Once
      the pre-specified 400 mg by mouth two times a day (PO BID) dosing for both drugs is reached
      without toxicity, the study will close for accrual. If toxicity is noted prior to reaching
      the 400 mg PO BID dosing, then the dosing schedule that is deemed safest as per study design
      will be the one used for any future phase II study.
    

Detailed description: 
      Gleevec and Sorafenib have modest efficacy in androgen-independent prostate cancer (AIPC) and
      the fact that both agents can be given orally with what appears to be tolerable side effects,
      we hypothesize that combining both agents may provide patients with another effective regimen
      in a disease where therapeutic options are limited. This study is designed to investigate the
      safety of combining Gleevec and Sorafenib as well as feasibility in AIPC patients who have
      failed one or more lines of systemic chemotherapy. Once safety is established, a follow-up
      phase II study will commence to investigate efficacy.
    

Intervention name(s): Gleevec + Sorafenib
Intervention type(s): Drug
Intervention description(s): 400 mg Sorafenib every day (QD) 300mg Gleevec QD
Other intervention name(s): Imatinib mesylate; Nexavar
Intervention MeSH terms: Sorafenib; Imatinib Mesylate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: AIPC, Prostate cancer; prostate
HidraWear AX HS Study
Condition: Hidradenitis Suppurativa; Hidradenitis
MeSH terms: Hidradenitis Suppurativa; Hidradenitis
Study type: Interventional

Summary: 
      The product, HidraWear AX (www.hidrawear.com) is and adhesive free wound dressing system for
      the every day home care of Hidradenitis Suppurativa (HS), a debilitating disease of the skin
      for which there are limited wound dressing products.

      This is a study to assess the use HidraWear Ax vs current product and method of use, and to
      determine the impact on patients' quality of life.
    

Detailed description: 
      The objective is to evaluate the ease of use of Hidrawear AX compared to the subject's
      existing product use in 23 subjects with HS (Hidradenitis Suppurativa).

      Secondary objectives are to evaluate if Hidrawear AX:

        -  Is comfortable

        -  Improves quality of life

        -  Faster to use than the subject's existing product

        -  Reduces dressing related pain

        -  Secure dressing retention

      This pilot study will evaluate usability - the safety, efficacy and performance of HidraWear
      AX in the home setting. Quality of life, ease of use and comfort of Hidrawear AX will be
      assessed.

      The clinical effect of the wound pad will not be assessed.
    

Intervention name(s): HidraWear Ax
Intervention type(s): Device
Intervention description(s): An adhesive free wound dressing fixation device for people living with Hidradenitis Suppurativa (HS), Hidrawear AX, designed to make dressing changes quick and easy for subjects. The unique features of the product completely remove the use of adhesives on the skin.The body conforming garment acts as a second skin and incorporates largely perforated panels over wound affected areas, minimising skin contact and aerating the area. The main function of the perforated is to act as a retaining device for the wound pads. The garment facilitates easy insertion, removal, precise positioning and adjustment of a non- adhesive wound dressing onto the effected wound space. The perforated section of the garment sits on the outer surface of the dressing providing provisional fixation. Next, an outer patch is placed on the outside of the garment on the footprint of the dressing. Through a hook and loop mechanism the dressing is now fully secured in place.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care