bioihbjkbjnl/mcl2 huggingface dataset:
Emollients in the Management of Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to confirm that emollients play a major role in the maintenance
      therapy after clearing of inflammatory lesions and can reduce occurrence of flares in
      children with atopic dermatitis.
    


Intervention name(s): glycerol, paraffin (liquid and white soft); Atopiclair®; Locatop@; Locapred@
Intervention type(s): Drug; Device; Drug; Drug
Intervention description(s): 1 application in the morning and in the evening; 1 application in the morning, in the afternoon and in the evening; During the Run-In period:
1 application in the morning and in the evening during a maximum of 21 days; During the 3 months study treatment:
1 application in the evening in case of flare "
Other intervention name(s): Dexeryl®
Intervention MeSH terms: Desonide; Glycerol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: xerosis; dry skin; dermatitis; eczema; emollient; corticosteroid; flare
Glucose Metabolism and Quality of Life in Healthy Women
Condition: Healthy
Study type: Observational

Summary: 
      Polycystic ovary syndrome (PCOS) is a common endocrine disorder in premenopausal women. Women
      with PCOS often have problems with fertility, unwanted hair growth, and irregular menstrual
      cycle. PCOS is associated with obesity, changes in glucose metabolism and low quality of
      life.

      In the present study, hormonal profile, glucose metabolism, adrenal functon, androgen levels,
      cortisol metabolism, anflammatory response, ovarian morphology, body composition, pfysical
      activity and quality of life is studied in 40 healthy women. The results will be compared
      with results from studies on women with PCOS in order to investigate any differences in these
      parametres.
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        40 healthy women with regular menstrual cycle, normal hair growth, and body mass index
        between 18 and 35 kg/m2
      
Biospecimen description: 
      blood and urine samples
    
Keywords: Healthy women; Quality of life; Glucose metabolism; Adrenal reactivity; Physical activity; Body Composition
Nutrition and Growth in Very Preterm Infants
Condition: Premature; Growth
Study type: Observational

Summary: 
      This study aims to explore the relation of early nutritional intake, especially oral
      nutrition intake, with growth and body composition among very preterm or very low birth
      weight infants.
    

Detailed description: 
      As the survival of very preterm infants increases, it is important to evaluate their
      long-term outcomes. Nutritional intake during early life was important to the growth and
      development in infants, especially in preterm infants. Studies found that early nutrition
      exposure in preterm infants can effect scored of Griffith Mental Development Scales and body
      fat percentage at later life. Insulin-like growth factor-1, leptin, Ghrelin, C-Peptide are
      associated with fat mass in children. And accumulation of fat and insulin resistance (IR) in
      the early postnatal period are related to metabolism diseases in adulthood. However, previous
      studies on nutrition and growth or the body composition of preterm infants were mostly
      completed in developed countries, and no relevant data were available in China. Therefore,
      this study aims to establish a prospective cohort of very preterm infants to observe the
      effects of nutritional exposure in early life on growth and body composition in later life.
    

Intervention name(s): Oral nutritional intake
Intervention type(s): Other
Intervention description(s): The exposure are oral nutritional intake and all nutritional intake during early life (28 days), and insulin-like growth factor 1, leptin, Ghrelin, and C-peptide in serum at corrected age 40 gestational weeks.
Other intervention name(s): All nutritional intake; Insulin-like growth factor 1; Leptin; Ghrelin; C-peptide
Intervention MeSH terms: Insulin
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Very preterm or very low birth weight infants in NICU
      
Biospecimen description: 
      Serum
Leuprolide in Treating Adults With Hypogonadotropism
Condition: Hypogonadism
MeSH terms: Hypogonadism
Study type: Interventional

Summary: 
      RATIONALE: Hypogonadotropism is an abnormal condition caused by decreased production of
      gonadotropins, a group of hormones that stimulate the parts of the reproductive system that
      produce and release eggs from the ovaries or sperm from the testicles. Leuprolide may
      stimulate the production of gonadotropins and be effective in increasing testosterone in men
      and inducing ovulation in women.

      PURPOSE: Clinical trial to study the effectiveness of leuprolide in treating adults who have
      hypogonadotropism.
    

Detailed description: 
      PROTOCOL OUTLINE: Male patients receive leuprolide subcutaneously every 5 days for up to one
      year and are followed at weeks 4, 6, 8, and 12, then every 2 months.

      Female patients receive leuprolide subcutaneously on days 1, 6, and possibly 11. Patients are
      followed 2 months after the last injection.

      Completion date provided represents the completion date of the grant per OOPD records
    

Intervention name(s): leuprolide
Intervention type(s): Drug
Intervention MeSH terms: Leuprolide
Primary purpose: Treatment
Keywords: endocrine disorders; hypogonadism; rare disease
A Multicenter Assessment of LBR-101 in High Frequency Episodic Migraine
Condition: Episodic Migraine Headache
MeSH terms: Migraine Disorders; Headache
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether monthly subcutaneous administration of
      LBR-101 (fremanezumab) is safe and provides migraine prevention in subjects with high
      frequency episodic migraine.
    


Intervention name(s): LBR-101 High Dose; LBR-101 Low Dose; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Subcutaneously Administered High Dose LBR-101 Monthly x 3; Subcutaneously Administered Low Dose LBR-101 Monthly x 3; Subcutaneously Administered Placebo (Vehicle) Monthly x 3
Other intervention name(s): Fremanezumab; Fremanezumab
Intervention MeSH terms: Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: High Frequency Episodic Migraine Headache; Episodic Migraine Headache; Migraine Headache
Anatomic Anterior Cruciate Ligament With Short Hamstring Graft Compare With a Standard Hamstring Graft Technique
Condition: Anterior Cruciate Ligament Injuries
MeSH terms: Anterior Cruciate Ligament Injuries
Study type: Interventional

Summary: 
      this study was to evaluate the functional outcome of quadruple hamstring graft in femoral
      tunnel less than 15 mm and morethan or equal 15 mm of ACL reconstruction. The hypothesize
      that no difference intermediate follow up ( 6 month - 24 month) of functional outcome and
      clinical evaluation between short and normal femoral tunnel graft length of hamstring tendon
      ACL reconstruction.
    

Detailed description: 
      The patient recruitment (N=29) and baseline data collection were done at our institute
      between March2014-September 2015. The inclusion criteria were patients with anterior cruciate
      ligamentous injury who needed ligamentous reconstruction, closed growth plates and younger
      than 60 years old, absence of ligament injury to the opposite knee. The exclusion criteria
      are patients who did not want to participate in this study or patient with failed anterior
      cruciate ligamentous reconstruction.

      All the procedure of anterior cruciate ligament reconstructions were performed by the senior
      authors (B.C). Semitendinosus and gracilis tendons were harvested through an oblique approach
      medial to the tibial tubercle in all patients. Complete anterior cruciate ligament was
      confirmed at arthroscopy. Associated intra-articular injuries such as meniscus tear and
      cartilage lesions were fixed at of the index operation .The femoral tunnel were drilled
      though the AM portal.
    

Intervention name(s): Anatomic anterior cruciate ligament with short hamstring graft technique; Anatomic anterior cruciate ligament with a standard hamstring graft technique
Intervention type(s): Procedure; Procedure
Intervention description(s): ACL and short hamstring graft; ACL with standard hamstring graft
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ACL; short hamstring graft; standard hamstring graft
Repair of Thumb Defect by Using the Toe Nail Flap
Condition: Thumb Injury
Study type: Observational

Summary: 
      The thumb accounts for 50% of the total hand function. This study reports the functional
      outcomes and complications of people with traumatic thumb amputations who underwent
      toe-to-thumb reconstruction.From 2013-01 to 2018-01, 29 patients with second-degree thumb
      defect underwent thumb reconstruction with distal phalangeal braided toenail flap. The
      footscan foot pressure gait analysis system was used to measure the index changes of the same
      foot before and after one, three and six months. The contact area, peak pressure, impulse
      value, contact time of each gait phase, centre of gravity coordinate and foot balance were
      analysed statistically. Twenty-nine cases of thumb reconstruction recovered well. After
      following up for 6-15 months, the appearance of the reconstructed thumb was close to normal,
      and the sensation was restored to S3+. The two-point discrimination was 6-8 mm, and the
      function of the thumb was good. The function of the donor foot was well restored, and no skin
      ulceration, pain and claudication were noted during walking. Compared with that before
      operation, the biomechanical indices of the donor foot were basically restored to normal six
      months after operation. Only the stress and impulse values of the third metatarsal head were
      significantly increased, forming a stress concentration area centred on the third metatarsal
      head.This study confirmed that the toe nail flap with distal phalangeal bone restored the
      second-degree thumb defect without destroying the main functional structure of the sole. The
      biomechanical indices of the donor foot were basically restored to normal six months after
      operation. Only the stress concentration area centred on the third metatarsal head, and the
      pain on the forefoot was induced after the operation. Discomfort, callus formation,
      metatarsal fasciitis, etc. can lead to fatigue fracture of the third metatarsal bone in
      severe cases, which requires further follow-up and observation.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The causes of injury were as follows: 2 cases of amputation and loss, 21 cases of machine
        rolling damage, 5 cases of rotational tear and replantation failure and 1 case of childhood
        traumatic defect. The patients included 19 males and 10 females with age of 17-46 years
        (mean 29.1 years), height of 156-179 cm (average 170.4 cm), weight of 50-80 kg (average
        62.3 kg) and foot length of 23-26 cm (average 24.5 cm). The defect cases included 12 on the
        left side of the toe and 17 on the right side.
      
Keywords: Amputation; thumb reconstruction; toe transfer; foot morbidity; biomechanics
The Effect of Weight Loss on Bone in Men
Condition: Weight Loss; BMD
MeSH terms: Weight Loss
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effect of weight loss on bone health in men.
    

Detailed description: 
      This pilot study of the effect of weight loss on bone health in men is being undertaken in
      conjunction with studies of the effect of weight loss on bone health in women for comparison
      purposes. See NCT00473031, NCT00472680, and NCT00472654. This information is important for
      determining optimal nutrient requirements during weight loss.

      Participants will be recruited for both weight loss and weight maintenance. All participants
      will be asked to take a daily vitamin/mineral supplement and, depending on their usual food
      intake, they may be asked to take a calcium tablet to meet the recommended intake throughout
      the study period. Weight loss participants will attend regular counseling sessions (about 45
      minutes each) with a dietitian for approximately 6 months; they will be asked to attend 6
      sessions but will be given the opportunity to attend 13 sessions. Body composition will be
      measured by a dual-energy x-ray absorptiometry (DXA) machine, ultrasound, and peripheral
      quantitative computer tomography (pQCT) before and after 6 months of weight loss. Bone,
      mineral, protein and lipid markers, and hormones that influence bones will also be measured.
    

Intervention name(s): Weight Loss; Weight Maintenance
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Weight loss participants will consume a reduced calorie diet based on their individual caloric needs to lose 1.5-2 lbs/week, and will attend regular counseling sessions (for about 45 minutes each) with a dietitian for 6 months; Diet for weight maintenance for 6 months
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: bone mass; calcium absorption; bone quality; fracture risk; arthritis; osteoporosis
Aggrastat to Zocor (AtoZ) - the Use of Two Approved Drugs to Treat Patients Who Have Experienced Chest Pain or a Heart Attack (0733-180)
Condition: Acute Coronary Syndrome
MeSH terms: Acute Coronary Syndrome; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      A-Phase: Evaluating patients with chest pain who are receiving approved drugs, to estimate
      the effectiveness of one type of blood thinner as compared to another type of blood thinner.

      Z-Phase: To evaluate early treatment of patients with long term chest pain (using an approved
      drug for 30 days, followed by an increased dose of the drug) as compared to patients (treated
      with diet and 4 months placebo followed by diet and approved drug) in patients who have
      experienced acute chest pain or heart attack.
    


Intervention name(s): A-Phase: tirofiban; Z-Phase simvastatin; Duration of Treatment: A-Phase: minimum suggested 48 hours, maximum suggested 108 hours. Z-Phase: 2 years; Comparator: A-Phase: low molecular weight heparin, unfractionated heparin; Duration of Treatment: A-Phase: low molecular weight heparin, 2 to 8 days; unfractionated heparin, minium suggested 48 hours, maximum 108 hours; Duration of Treatment: Z-Phase, 2 years.
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Heparin; Calcium heparin; Heparin, Low-Molecular-Weight; Tinzaparin; Dalteparin; Tirofiban; Simvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Pharmacokinetics of Tasimelteon in Subjects With Renal Impairment and Matched Control Subjects With Relatively Normal Renal Function
Condition: Renal Impairment
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this research study is to understand whether there is any difference in the
      amount of tasimelteon (including its breakdown products) in the blood of individuals with
      severe renal impairment compared to individuals who have normal renal function. The safety
      and tolerability of tasimelteon will also be assessed throughout this study.
    


Intervention name(s): Tasimelteon; Tasimelteon
Intervention type(s): Drug; Drug
Intervention description(s): 20mg capsule, once; 20mg, once
Other intervention name(s): VEC-162
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: End stage renal disease; ESRD; kidney disease; renal impairment; renal
SWAN: Study on the Tolerance and Efficacy of a New Anti-regurgitation Formula (PC-2016-01)
Condition: Gastroesophageal Reflux
MeSH terms: Gastroesophageal Reflux
Study type: Interventional

Summary: 
      The aim of this study is to evaluate the efficacy of a new thickened formula on regurgitation
    


Intervention name(s): Thickened infant formula
Intervention type(s): Dietary Supplement
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Bioavailability Study of Valacycovir HCl Tablets, 1000 mg of Dr. Reddy's Under Fed Condition
Condition: Healthy
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to

        1. Compare and evaluate the single-dose bioavailability study of 1000mg Valacyclovir HCl
           tablets of Dr. Reddy's and Valtrex (R)(Valacyclovir Hydrochloride)CAPLETS 1 gram of
           GlaxoSmithkline, in healthy, adult human subjects under fed conditions.

        2. monitor the adverse events and ensure the safety of subjects.
    

Detailed description: 
      An open label, balanced, randomized, two-treatment, two-sequence two-period, single-dose,
      crossover comparative bioavailability study of 1000 mg Valacyclovir Hydrochloride Tablets of
      Dr. Reddy's Laboratories Ltd., India and valtrex (R) (Valacyclovir Hydrochloride) CAPLETS 1
      gram of GlaxoSmithkline in healthy, adult human subjects under fed conditions
    

Intervention name(s): Valacyclovir Hydrochloride
Intervention type(s): Drug
Intervention description(s): Valacyclovir Hydrochloride Tablets, 1000 mg of Dr. Reddy's Laboratories Limited
Other intervention name(s): Valtrex (R)(Valacyclovir Hydrochloride) CAPLETS 1 gm
Intervention MeSH terms: Valacyclovir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioequivalence; Crossover; Valacyclovir Hydrochloride
A Study to Compare the Menstrual Bleeding Profile Among Jaydess® and Copper Intrauterine Device (IUD) Users. COLIBRI STUDY (Copper and Levonorgestrel IUD Barcelona Research Initiative).
Condition: Contraception
MeSH terms: Hemorrhage
Study type: Interventional
Phase: Phase 4

Summary: 
      The intrauterine device (IUD) is a long-term birth control method that has demonstrated high
      contraceptive efficacy and effectiveness due to its high compliance, adherence and
      persistence of use. The IUD has a global prevalence rate around 14% in women of reproductive
      age.

      Side effects are the main reason for IUD use discontinuation. The most common reasons for
      copper IUD discontinuation are increased menstrual bleeding, irregular bleeding and
      dysmenorrhea, whereas in the case of 52mg Levonorgestrel IUD are irregular bleeding and
      amenorrhea.

      In 2014, a new hormonal IUD containing13,5mg of Levonorgestrel was marketed in Spain. There
      are many studies comparing the two Levonorgestrel IUDs. However, there is any study comparing
      the IUD 13,5mg Levonorgestrel with classic copper IUDs.

      The hypothesis of this trial is that Levonorgestrel (13,5mg) IUD users have a menstrual
      bleeding pattern with fewer days than Copper 380 mm2 IUD users.

      This is a Phase IV, national single-center, randomized 1: 1, single-blind, comparative,
      parallel controled trial.
    


Intervention name(s): Levonorgestrel (13,5 mg) intrauterine device; Cooper (380mm2) intrauterine device
Intervention type(s): Drug; Device
Intervention MeSH terms: Levonorgestrel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Effects of AHEs on DrA in Postpartum Women
Condition: Diastasis Recti
MeSH terms: Diastasis, Muscle
Study type: Interventional

Summary: 
      This study is aimed to determine the effects of Abdominal Hypopressive exercises on IRD,
      Lumbopelvic pain, Body Image and abdominal muscle function in postpartum women.
    

Detailed description: 
      Postnatal women wish to resume abdominal exercises shortly after delivery to improve trunk
      function and restore the pre-pregnant state of the body. Diastasis recti is a common
      occurrence in the postpartum period which is associated with both physical impairments and
      body image concerns. Despite the high prevalence, treatment options are still being explored
      to identify the best approach to resolve it. Exercise is a conservative method to reduce IRD
      and improve the associated symptoms and quality of life of postpartum females. Most of the
      previous studies have used either digital nylon calipers or digital palpation methods for the
      outcome assessment of DrA which has important implications. Fewer studies have used the gold
      standard US diagnosis. Despite various studies being conducted on the effect of exercise on
      DrA, the results are still nonconclusive with a deficiency of a standardized protocol.
      Multifaceted and clinically meaningful assessments have been proposed to be investigated by
      the previous literature.
    

Intervention name(s): Abdominal Hypopressive Training; Conventional Physical therapy for DrA
Intervention type(s): Other; Other
Intervention description(s): Week 1 and 2 - Patient education , Hypopressive Maneuvers in Standing, Sitting and Supine 5-7 repetitions x 5 sets, with a 10-second hold each time, rest for 30 seconds between each set, 2 days/week.
Week 3 and 4, Hypopressive breathing in with varying arm movements along with Week 1 and 2 protocols.
Week 5 to 8 - Hypopressive breathing in kneeling, Four-point kneeling and sitting, and supine positions with varying arm movements 5-7 repetitions x 5 sets, with a 10-second hold each time, rest for 30 seconds between each set, 2 days/week.; Week 1 to 4, Draw-in maneuver in supine, Quadruped and Prone lying, Bent knee Fallouts and Curl ups. (8 to 12 repetitions x 3 sets, 2 days/week)
Week 5 to 8, Front and side planks added to week 1 to 4 exercises. (12 to 20 repetitions x e sets, 2 days/week)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Diastasis Recti; Diastasis Recti and weakness of Linea alba; Low back pain