bioihbjkbjnl/mcl2 huggingface dataset:
To Assess the Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in Italy
Condition: Growth Disorders
MeSH terms: Growth Disorders
Study type: Observational

Summary: 
      This is an Italian, Multicentre, Observational Study to study Adherence and Long Term
      Outcomes of Therapy in paediatric subjects using easypod™ electromechanical device for growth
      hormone treatment to assess the level of adherence of subject receiving SAIZEN® via easypod™.
    

Detailed description: 
      Subjects will be enrolled in a multicenter longitudinal observational study. Parents or
      guardian and subjects (when applicable) will provide their Informed Consent to upload their
      data for population-based analyses and, ultimately, clinical outcomes. Adherence data will be
      primarily derived from the easypod™ device combined with physician data entry of outcome
      measures. Data will be collected retrospectively and prospectively. This will allow the
      establishment of adherence profiles and subsequent clinical outcomes. Collected data will be
      also analyzed in a multinational pooled analysis of comparable national studies.

      Primary Objective:

      • To assess the level of adherence of subjects receiving SAIZEN® via easypod™

      Secondary Objectives:

        -  To describe the impact of adherence on clinical outcomes for subject receiving SAIZEN®
           via easypod™

        -  To identify adherence subject profiling

        -  To asses the impact of adherence on Insulin-like Growth Factor 1 (IGF1) (i.e. above,
           below or within normal ranges)
    

Intervention name(s): Device: easypod™
Intervention type(s): Device
Intervention description(s): Saizen (Somatotropin) as per Summary of Product Characteristics administered by easypod™
Other intervention name(s): Somatotropin
Observational model: Cohort
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Paediatric subjects (aged 2-18) who are taking SAIZEN® for registered indications using the
        easypod™ electromechanical device.
      
Keywords: Growth disorders; Saizen; Easypod; Growth hormone; Pediatric subject
Alendronate and/or Parathyroid Hormone for Osteoporosis
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This study looks at the effects of two medications, alendronate and parathyroid hormone, on
      bone mass and on bone formation and bone breakdown in women with osteoporosis. We will
      randomly select postmenopausal women who have osteoporosis to receive laboratory-produced
      human parathyroid hormone (hPTH), or alendronate, or both for 2.5 years. Study participants
      will return to the study center periodically to have their bone mass measured and to give
      blood and urine samples for tests of bone formation and breakdown and for other laboratory
      tests. Those who complete the study are eligible for one or two 12 month extension studies.
    

Detailed description: 
      This is a randomized, prospective, open-label study in which osteoporotic postmenopausal
      women self-administer synthetic hPTH-(1-34), alendronate, or both, every day for 2.5 years.
      Participants initially come to Massachusetts General Hospital once a month, and subsequently
      once every 3-6 months, for measurements of serum and urine indices of bone formation and
      resorption, serum and urine toxicity tests, and DXA/QCT measurements of bone mass. One-third
      of the participants take hPTH-(1-34) daily, one-third take alendronate once daily, and
      one-third take both daily (Phase A, months 0-30).

      Participants who complete Phase A are eligible for a 12 month extension study (Phase B,
      months 30-42), during which any alendronate treatment is continued without change and any
      hPTH 1-34 treatment is stopped.

      Participants who complete Phase B are eligible for a second 12 month extension study (Phase
      C, months 42-54), during which any alendronate treatment is continued without change and
      every participant takes hPTH 1-34.

      During Phases B and C, these participants come to Massachusetts General Hospital once every 6
      months for measurements of serum and urine indices of bone formation and resorption, serum
      and urine toxicity tests, and DXA/QCT measurements of bone mass.
    

Intervention name(s): Human parathyroid hormone [hPTH-(1-34)]; alendronate
Intervention type(s): Drug; Drug
Intervention description(s): 37 mcg once daily by self-administered sc injection; 70 mg/week by oral route
Other intervention name(s): teriparatide; Fosamax
Intervention MeSH terms: Alendronate; Teriparatide; Hormones; Parathyroid Hormone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Osteoporosis; Bone formation; Bone resorption; Parathyroid hormone (PTH); Postmenopause
Internet-delivered Emotion Regulation Individual Therapy for Adolescents With NSSI - An Open Pilot Study
Condition: Nonsuicidal Self-Injury
MeSH terms: Self-Injurious Behavior
Study type: Interventional

Summary: 
      The primary aim is to investigate the effectiveness of an Internet-delivered Emotion
      Regulation Individual Therapy for Adolescents (ERITA) with nonsuicidal self-injury (NSSI).
    


Intervention name(s): Internet-delivered Emotion Regulation Individual Therapy for Adolescents
Intervention type(s): Behavioral
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Nonsuicidal Self-Injury (NSSI), Deliberate Self-Harm (DSH), Self-harm, Self-injury
The Effectiveness of Neurodynamic Techniques in Patients With Nerve-Related Leg Pain
Condition: Nerve Pain; Peripheral Nerve Injuries; Peripheral Nervous System Diseases; Sciatica; Low Back Pain; Low Back Ache; Signs and Symptoms
MeSH terms: Nervous System Diseases; Sciatica; Peripheral Nerve Injuries; Peripheral Nervous System Diseases; Neuralgia; Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      This study aims to verify if patients with nerve-related leg pain benefits from neurodynamic
      treatment over two weeks.
    

Detailed description: 
      Nerve-related leg pain (NRLP) although less prevalent than low back pain itself, is
      associated with higher economic and social burden, and has been considered a predictor of
      chronicity and disability among subjects with low back pain.

      Numerous approaches are proposed for its management; however, evidence regarding the best
      therapeutic approach is lacking. Neurodynamic techniques are proposed to be effective to
      manage NRLP.

      Thus, this study aims to verify, through a randomized controlled trial, the effectiveness of
      a two-week program of neurodynamic techniques on pain and disability in individuals with
      NRLP.
    

Intervention name(s): Neurodynamic Group
Intervention type(s): Procedure
Intervention description(s): All techniques will be executed in a pain-free way (grade III). Mild discomfort will be accepted, but it must subside as soon as the technique ends.
In the dynamic opener technique, patient will be positioned in side-lying, with the affected side upwards. The therapist will then perform grade III oscillations aiming to open the lumbar foramen;
In the side-lying slider, the patient will be in side-lying with the affected side upwards. A combination of knee and hip flexion and extension movements will produce sliding in the neural structures;
In the slump slider, the patient will be seated in slump position. Combinations between neck and knee movements will produce greater nerve excursion than the side-lying slider. Patients will perform the slump slider in a pain-free manner.
Other intervention name(s): Neural mobilization; Sliders; Tensioners; Nerve tissue management
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Sciatica; Nerve pain; Low back pain
The Effect of Aerobic Exercise in Overweight and Obese Women
Condition: Obesity; Overweight
MeSH terms: Overweight
Study type: Interventional

Summary: 
      Study design The study was designed as a prospective controlled randomized trial.
      Participants were randomly assigned to one of two groups. In the experimental group,
      participants (n = 17) received 8-week aerobic exercise intervention without nutrition
      modifications. In the control group, participants (n = 16) did not undergo any intervention
      and were instructed to maintain their regular physical activity and diet regime for 8 weeks.

      Experimental measurements: Anthropometric measurements, Measurement of BDNF, Cardiac
      autonomic responses, Measurement of aerobic fitness, Measurement of cognitive functions.
    


Intervention name(s): Aerobic exercise
Intervention type(s): Other
Intervention description(s): 8-week aerobic exercise (moderate intensity), 5 times per week, 60 min per session. Exercise training under supervision of trained staff.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Impact of Pre-pregnancy Micronutrient Supplementation on Maternal and Child Outcomes
Condition: Anemia; Intrauterine Growth Retardation; Preterm Delivery; Iron Deficiency
MeSH terms: Premature Birth; Fetal Growth Retardation; Iron Deficiencies
Study type: Interventional

Summary: 
      The study evaluates the efficacy of providing weekly iron-folate (IFA) supplements or
      Multiple Micronutrient (MM) supplements before pregnancy in increasing birth weight and
      duration of gestation as well as maternal and infant iron status.
    

Detailed description: 
      Low birth weight and anemia remain intractable problems in many developing countries despite
      considerable efforts to address them. Intervening with just prenatal iron-folate (IFA)
      supplements may not be the best approach given the substantial demands for iron by maternal
      and fetal tissues. Therefore, there is an urgent need to evaluate the additional contribution
      of prepregnancy interventions.

      The study evaluates the efficacy of providing weekly iron-folate (IFA) supplements or
      Multiple Micronutrient (MM) supplements before pregnancy in increasing birth weight and
      duration of gestation as well as maternal and infant iron status.
    

Intervention name(s): Multiple Micronutrient; Iron and Folic Acid; Folic Acid
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): There is no current recommendation for weekly MM supplements for WRA. Therefore, we propose a supplement that contains: The same amounts of iron and folic acid as the weekly, pre-natal IFA supplement; An amount of vitamin D based on the Food and Nutrition Board's Recommended Daily Allowances (RDA); UNICEF/WHO/UNU recommended amounts of remaining nutrients (UNIMMAP recommendations). The supplement is taken weekly during pre-pregnancy.
Vitamin A (μg) 800 Vitamin D (IU) 600 Vitamin E (mg) 10 Vitamin C (mg) 70 Thiamine (mg) 1.4 Riboflavin (mg) 1.4 Niacin (mg) 18 Vitamin B6 (mg) 1.9 Vitamin B12 (μg) 2.6 Folic acid (μg)* 2800 Iron (mg)* 60 Zinc (mg) 15 Copper (mg) 2 Selenium (μg) 65 Iodine (μg) 150; The doses of weekly and daily iron (60mg) and folic acid (2800μg) are based on current WHO recommendations for WRA.; It is unethical to have a placebo group as FA is universally recommended for WRA to prevent neural tube defects. Therefore, the control group will receive 2800 μg FA once a week during the pre-pregnancy period. This dosage is safe and meets the minimum recommended intake of 400 μg/d for Women of Reproductive Age (WRA). Recent studies have shown that a weekly dose of 2800 μg FA is as effective as a daily dose of 400 μg in improving folic acid and reducing homocysteine levels among WRA.
Intervention MeSH terms: Folic Acid; Vitamin B Complex; Micronutrients; Trace Elements
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: prepregnancy; micronutrient; supplementation; maternal; child; health
FreeStyle Libre- Effect on QOL in Type 2 Diabetes Patients
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      This is a randomized controlled study in type 2 diabetic patients who are presently
      uncontrolled on at least 2 injections of insulin daily with an A1C >7.5 % and <10%. Patients
      need to be stabilized on their MDI for 1 week then randomized to either SBGM or FreeStyle
      Libre for 10 weeks.
    

Detailed description: 
      FreeStyle Libre Flash Glucose Monitoring System is an interstitial glucose monitoring system
      intended to be replacement for the capillary blood glucose measurement. The system contains
      several features that distinguish it from exiting sensor technology including no user
      calibration during 14 days of wear. The sensor is applied to the upper arm of the patient and
      the hand-held reader is used to scan the sensor to receive glucose result along with historic
      results with a 15 min frequency for up to 8 hours.

      An AGP (=Ambulatory Glucose Profile) report is a way to present the glucose data collected by
      the time of day that has several advantages: demonstrates median glucose levels and the
      25-75%, 10-90% excursions as well as the tendency for hypo or hyperglycemia throughout the
      day. This integration of results gives a more complete picture of the glucose control
      throughout the week/s while eliminating the "noise" from outliers.

      The hypothesis is that the addition of FreeStyle Libre system for 10 weeks to the treatment
      of uncontrolled Type 2 diabetic patients currently on MDI, will produce a modification of
      behavior/life style and improvement in treatment satisfaction, quality of life and glycemic
      control and reduce the number of any/major hypoglycemia events.
    

Intervention name(s): FreeStyle Libre; personal glucometer
Intervention type(s): Device; Device
Intervention description(s): Addition of FreeStyle Libre system for 10 weeks to the treatment of uncontrolled Type 2 diabetic patients currently on multiple daily injections; Subjects in the Control Group will measure blood glucose levels by personal glucometer (SMBG = self monitoring blood glucose)
Other intervention name(s): SMBG
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: insulin treated
Circadian as A Prognostic Factor For Radiation Response in Cervical Cancer
Condition: Cervical Cancer; Radiotherapy Side Effect
MeSH terms: Uterine Cervical Neoplasms
Study type: Interventional

Summary: 
      The study was a Randomized Clinical Trial (RCT) or clinical trial comparing the results of
      radiation treatment of 2 treatment groups, i.e. subject groups irradiated in the morning and
      in the afternoon, to check melatonin levels in cervical cancer patients. Since it is known
      that the function of melatonin is as an antiproliferation substance or hormone, induces
      apoptosis, inhibits invasion and metastasis.
    


Intervention name(s): Afternoon Radiation
Intervention type(s): Radiation
Intervention description(s): Melatonin, a hormone of the pineal gland, which levels are characteristic of circadian patterns, regulated with low levels of excretion in the afternoon, rises gradually during the night, peaks at dawn, and falls back in the afternoon and late afternoon. Many studies prove the function and potential of melatonin as circadian biomarkers and well correlated with the development of cancer.The function of melatonin is as an antiproliferation substance or hormone, induces apoptosis, inhibits invasion and metastasis.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Treatment
Keywords: Radiosensitivity; Circadian rhythm
The Effect of Trunk Control on Respiratory Muscle Strength
Condition: Cerebral Palsy, Spastic; Posture; Respiratory Muscle Strength; Activities of Daily Living
MeSH terms: Cerebral Palsy
Study type: Observational [Patient Registry]

Summary: 
      Cerebral palsy (CP) can be defined as a group of disorders of movement and posture, causing
      activity limitation that are attributed to nonprogressive deficits that take place in the
      immature brain. The motor disorders of CP are often accompanied by deficits in sensation,
      cognition, communication, perception, behavioral and respiratory system .

      Children with CP have many primary motor impairments such as selective mobility, muscle
      weakness, abnormal muscle tone, impaired coordination between agonist-antagonist muscles and
      insufficient postural control. These motor impairments also lead to secondary problems such
      as contractures and bone deformities. Whether primer or secondary, all these problems can
      reduce independence in activities of daily living (ADL) by affecting CP children at different
      levels.

      There are several studies in children with CP that investigate the effects of trunk control
      and/or respiratory functions. However, there are very few studies examining the relationship
      of these functions which have direct effects on ADL. In these studies, the functions of
      children who are more heavily affected and unable to move have been examined. However, there
      are no studies examining the effect of trunk control on respiratory muscle strength in
      children with CP with a better mobility level. There are many factors affecting both trunk
      control and respiratory functions in these children. Therefore, in children with CP, who have
      better functional level and can move on their own, revealing the interaction between trunk
      control and respiratory functions may contribute significantly to the treatment process. For
      this reason, this study was planned to investigate the effect of trunk control on ADL and
      respiratory muscle strength in children with CP having a Gross Motor Functional
      Classification System (GMFCS) levels of 1 and 2 and to compare them with healthy children.
    

Detailed description: 
      Trunk control was evaluated by Trunk Control Measurement Scale (TCMS), ADL was evaluated by
      Pediatric Evaluation of Disability Inventory (PEDI) and respiratory muscle strength was
      evaluated by mouth pressure meter.
    

Observational model: Other
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Children with Cerebral Palsy and healthy volunteers.
Safety Study of Pegylated Interferon Lambda Plus Single or 2 Direct Antiviral Agents With Ribavirin
Condition: Hepatitis C
MeSH terms: Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      Substudy C: The purpose of this substudy is to determine whether Lambda combined with
      Ribavirin and Daclatasvir for 12 weeks is efficacious in treatment naïve subjects with
      genotype 1b chronic HCV infection
    


Intervention name(s): Pegylated Interferon Lambda; Ribasphere; Daclatasvir
Intervention type(s): Biological; Drug; Drug
Other intervention name(s): BMS-914143; Ribavirin; BMS-790052
Intervention MeSH terms: Interferons; Ribavirin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Comparison of Tissue Adhesive Material and Suture as Wound-closure Techniques Following Carpal Tunnel Decompression
Condition: Carpal Tunnel Syndrome
MeSH terms: Carpal Tunnel Syndrome
Study type: Interventional

Summary: 
      Participants will be randomly assigned to suture-based wound closure (n=50) or tissue
      adhesive-based wound closure (n=50) with two-component skin adhesive Glubran Tiss 2®. The
      outcomes will be assessed during the follow-up period at intervals of 2, 6, and 12 weeks
      postoperatively. A scar assessment will be using the POSAS (Patient and Observer Scar
      Assessment Scale) and cosmetic VAS (Visual Analog Scale). The VNRS (Verbal Number Rating
      Scale) will used to assess pain.
    


Intervention name(s): two-component skin adhesive, Glubran Tiss 2; skin is stitched with transcutaneous nylon sutures
Intervention type(s): Procedure; Procedure
Intervention description(s): After subcutaneous stitches a two-component skin adhesive, Glubran Tiss 2®, will be applied. G Each subject will receive 0.35 mL of Glubran Tiss® in the open wound, and before bandaging, subjects rested for 20 minutes for a polymerization process.; The skin is stitched with transcutaneous nylon sutures (polypropylene-polyethylene monofilament, non-absorbable surgical suture) 4-0
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Compare Anti-inflammatory Dentifrices
Condition: Gingivitis
MeSH terms: Gingivitis
Study type: Interventional
Phase: Phase 4

Summary: 
      Plaque induced gingivitis
    


Intervention name(s): Triclosan/Copolymer/fluoride toothpaste; Sodium monofluorophosphate toothpaste
Intervention type(s): Drug; Drug
Intervention description(s): Twice daily usage; Twice daily usage
Other intervention name(s): Toothpaste includes triclosan/fluoride/co-polymer (Total); fluoride only toothpaste
Intervention MeSH terms: Triclosan; Fluorides; Fluorophosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Improving Uptake and Adherence to HIV Prevention Services With Pre-exposure Prophylaxis (PrEP), HIV Self- Testing and Adherence Support for Very High Risk HIV-negative Young Women Aged 15-24 in Kampala, Uganda
Condition: HIV/AIDS
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional

Summary: 
      The main aim is to develop and assess an intervention to enhance initiation and adherence to
      PrEP among HIV negative young women of high risk (YWHR). The specific aims are (1) To conduct
      formative research to enhance our understanding of the dynamics of the social and sexual
      networks, and context of young HIV-uninfected women (aged 15-24) engaged in high risk sexual
      behavior in Kampala, Uganda (2) Document barriers and opportunities for PrEP uptake and
      adherence as well as repeat HIV testing by self test; (3) To develop and test a socially and
      culturally acceptable and feasible prevention intervention on uptake and adherence to PrEP
      and HIV self-testing for young women at high risk for HIV.
    


Intervention name(s): POPPi behavioral intervention; POPPi behavioral intervention
Intervention type(s): Behavioral; Behavioral
Intervention description(s): behavioral intervention with offer of HIV self test; behavioral intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention