bioihbjkbjnl/mcl2 huggingface dataset:
Nutritional Intervention Preconception and During Pregnancy to Maintain Healthy Glucose Metabolism and Offspring Health
Condition: Hyperglycemia
MeSH terms: Hyperglycemia
Study type: Interventional

Summary: 
      The study aims to assess whether a nutritional drink taken before conception and continuing
      through pregnancy, assists in the maintenance of healthy glucose metabolism in the mother and
      promotes offspring health.
    

Detailed description: 
      It is known that maternal insulin resistance and high blood glucose levels in early pregnancy
      alter the functioning of the placenta in ways that persistently affect the supply of
      nutrients and fat in the unborn baby. There is an increasing focus on the need to optimise
      preconception nutrition but as yet, limited preconception interventions that are recognized
      as promoting health for the mother and her child.

      The Investigators will recruit up to 1800 women, aged 18-38 years, who are planning a
      pregnancy in the United Kingdom, Singapore and New Zealand with the aim of securing 600 or
      more pregnancies. The participants will be randomly allocated to receive the standard
      nutritional drink or the study nutritional drink. Women who conceive between one and twelve
      months after starting the nutritional drink will be followed through pregnancy and studied
      with their babies for three years after delivery. Various testing will be carried out at
      relevant time points. Mothers will undergo blood, urine, hair and cheek swab sampling,
      dual-energy X-ray absorptiometry (DXA) scans along with body measurements and health and
      lifestyle questionnaires. Infants will undergo hair, cheek swab, urine and stool sampling
      along with body measurements, measurements of body composition and a DXA scan. Placental,
      cord and other perinatal tissues/samples will be collected.

      The data collected will allow identification of the contributions of nutritional and
      lifestyle factors, social and economic status, ethnicity, genetics and metabolomics and gut
      microbes to maintaining healthy glucose metabolism in pregnancy, enhancing fertility, mood
      and reproductive outcomes in the mother, and promoting healthy growth, body composition and
      wellbeing in the children.

      The effect of the intervention on the primary outcome will be examined in two special
      interest groups; i) women who are overweight or obese prior to conception & ii) women with
      documented evidence of dysglycemia prior to conception.
    

Intervention name(s): Study nutritional drink; Standard nutritional drink
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Study nutritional drink containing a mix of micronutrients, probiotics and myo-inositol.; Standard nutritional drink containing a mix of micronutrients.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Nutrition; Glucose metabolism; Body composition
Prevalence of Vitamin D Deficiency in Type 1 Diabetes Mellitus and Effect of Supplementation on Insulin Requirements
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Vitamin D Deficiency
Study type: Interventional
Phase: Phase 3

Summary: 
      Our objective is to demonstrate that providing supplemental vitamin D to children with new
      onset DM will significantly decrease the levels of HbA1c and insulin requirement by the
      following methods.

        1. Identify how often vitamin D levels are low in patients with new onset Type 1 diabetes
           mellitus (DM).

        2. Record the hemoglobin A1c (HbA1c) level (which reflects the average blood sugar level
           over the past few months) and document insulin requirements before and after vitamin
           supplementation is given.

      Hypothesis: Maintaining vitamin D levels >30 ng/ml will decrease HbA1c and insulin
      requirements.
    

Detailed description: 
      New onset type 1 DM patients who present at William Beaumont Hospital, Royal Oak or to the
      Pediatric Endocrine Clinic will be approached about the study at their presentation and time
      will be given for the patient and family to discuss and ask questions regarding the study.
      Patients will then be enrolled following informed consent. Glucose levels and insulin
      requirements will be monitored continuously from the faxed weekly logbooks from the point of
      diagnosis for 3 months (as standard practice for all newly diagnosed diabetic patients in our
      clinic). At the baseline visit a Vitamin D level will be drawn and frozen for 3 months prior
      to processing. .After 3 months vitamin D, calcium, alkaline phosphatase, phosphorus and other
      standard of care lab draws will be done. Approximately an additional 3 tsp of blood will be
      taken. All female subjects of child bearing potential will have a pregnancy test done. EMLA
      cream to anesthetize the area will be used prior to blood draw. A vitamin D level of <30
      ng/ml is considered insufficient and the patient will then be given vitamin D supplement. The
      vitamin D level, calcium, alkaline phosphatase and phosphorus will be rechecked at 6 months
      (additional 3 tsp of blood) . Glucose levels and insulin requirements will be monitored
      continuously from the faxed weekly logbooks again for another 3 months.
    

Intervention name(s): Vitamin D
Intervention type(s): Drug
Intervention description(s): 2000iu once a day
Other intervention name(s): cholecalciferol
Intervention MeSH terms: Vitamin D; Cholecalciferol
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients with clinically significantly low Vitamin D levels (<30 ng/mL) were supplemented with Vitamin D and compared to patients with normal vitamin D levels (50-80 nG/mL).
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Diabetes; Type I; Newly Diagnosis Type I Diabetes Mellitus
Study of Eye Movement Testing and Therapy
Condition: Saccadic Eye Movement Deficiency; Oculomotor Deficiency; Oculomotor Dysfunction
Study type: Interventional

Summary: 
      The purpose of this study is to determine the ability of several eye movement monitors, used
      in clinical practice, to identify children with poor reading eye movements. A second purpose
      of the study is to evaluate the effectiveness of eye movement therapy.
    


Intervention name(s): eye movement therapy
Intervention type(s): Procedure
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of the PK of NRL972 Following Pre- and co-Administration of Ursodeoxycholic Acid and Cloxacillin
Condition: Hepatic Cirrhosis
MeSH terms: Liver Cirrhosis
Study type: Interventional
Phase: Phase 1

Summary: 
      A study in healthy volunteers to determine whether different drugs metabolised by the liver
      have any effects on how NRL972 is processed within the body.
    


Intervention name(s): NRL972; NRL972; NRL972
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single intravenous administration of 2 mg NRL972; Pre-treatment and co-treatment with 1 g Cloxacillin t.i.d. for three days from the morning of D-3 until the morning of Day D01 0:30 hour before the intravenous administration of NRL972.; Three week pre-treatment with daily doses of 500 mg b.i.d ursodeoxycholic acid from the morning of D-20 until the evening of Day D-1
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Class I Medical Device on Post-surgical Scars
Condition: Cicatrix; Post-Surgical Complication; Scar Itching; Keloid; Hypertrophic Scar
MeSH terms: Keloid; Cicatrix; Cicatrix, Hypertrophic
Study type: Interventional

Summary: 
      To compare the effect of a class I pullulan based medical device containing Allium cepa & HA
      versus a class I medical device silicone gel on new post-surgical wounds
    

Detailed description: 
      A head-to-head, randomised, pivotal controlled trial evaluating the appearance of
      post-surgical scars for 12 weeks. The study was developed in 10 months, including
      recruitment, evaluation every 4 weeks and evaluation of the secondary objective in the third
      month (T2). The primary endpoint was the evaluation of the effectiveness of the class I
      medical device contain onion (Allium cepa) extract compared to the silicone gel used in the
      treatment of post-surgical scars for the prevention of hypertrophic scars. Objective scar
      assessment using the Vancouver Scar Scale (VSS), Manchester Scale, Patient and Observer Scar
      Assessment Scale (POSAS), itching, redness and pliability were performed after 4,8 and 12
      weeks of treatment. Safety was also evaluated by gathering adverse events related to
      application of the gel. The statistical analysis of the data was carried out by applying
      parametric or non-parametric tests depending on the distribution of the data that was going
      to be obtained. The one-way analysis of variance ANOVA test was used to evaluate the
      reduction/increase of clinical parameters in the pre-established observation times (T0, T2,
      T3 and T4) for each treatment, whereas comparison between treatments was performed via t-test
      analysis. Correlation tests were also used. The differences were considered statistically
      significant for p values <0.05.
    

Intervention name(s): Kaloidon Plus; silicone gel
Intervention type(s): Device; Device
Intervention description(s): topical application; twice daily; topical application; twice daily
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: scar; Keloid; Cicatrix; allium cepa; silicone
Assessing Radio-hybrid Prostate Specific Membrane Antigen (rhPSMA-7.3) (18F) in Healthy Volunteers and Subjects With Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase 1, Open-label Study to Assess Safety, Biodistribution, and Internal Radiation
      Dosimetry of rhPSMA-7.3 (18F) Injection in Healthy Volunteers, and to Assess Safety and
      Investigate the Imaging Characteristics in Subjects With Prostate Cancer.
    


Intervention name(s): rhPSMA-7.3 (18F) Injection
Intervention type(s): Drug
Intervention description(s): Radioligand for PET CT scanning
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: Positron Emission Tomography (PET) Imaging study
Masking: None (Open Label)
Primary purpose: Diagnostic
Relative Bioavailability Study for GSK1278863A
Condition: Anaemia
Study type: Interventional
Phase: Phase 1

Summary: 
      A randomized, open-label, 3-period crossover study.
    

Detailed description: 
      A randomized, open label, 3-period crossover study in healthy subjects. The primary objective
      of this study is to determine the relative bioavailability of GSK1278863A after single oral
      doses of 100mg GSK1278863A tablets with particle sizes of 13, 29, or 41 micrometers (um) in
      healthy subjects.
    

Intervention name(s): GSK1278863A; GSK1278863A; GSK1278863A
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 100mg (x90=13um), oral tablet, single-dose with 7 day wash-out; 100mg (x90=29um), oral tablet, single-dose with 7 day wash-out; 100mg (x90=41um), oral tablet, single-dose with 7 day wash-out
Intervention MeSH terms: Glycine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: relative bioavailability
Web-based Addiction Treatment: Cultural Adaptation With American Indians
Condition: Substance Use Disorders
MeSH terms: Substance-Related Disorders
Study type: Interventional

Summary: 
      The purpose of the current study is to evaluate the preliminary efficacy of the Therapeutic
      Education System-Native Version (TES-NAV) (an efficacious web-delivered psychosocial
      intervention for substance use disorders adapted with American Indians/Alaska Natives
      [AI/AN]) to determine whether a future large-scale effectiveness trial is warranted.
      Specifically, a randomized controlled trial among urban AI/AN (N=80) attending outpatient
      addiction treatment services will be conducted to (1) estimate preliminary effect size of 12
      weeks of TES-NAV on substance use disorder outcomes; (2) explore relevant moderators of
      TES-NAV outcomes; and (3) assess cultural factors that may correspond to variation in
      outcome.
    


Intervention name(s): TES-NAV; TAU
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Internet-delivered psychosocial treatment grounded in the community reinforcement approach plus contingency management adapted for AI/AN; Standard outpatient addiction treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Digital therapeutics; Adaptation
Efficacy of Topical Indomethacin Patch Over Placebo in Ankle Sprain Pain Relief
Condition: Ankle Sprain
MeSH terms: Sprains and Strains; Ankle Injuries
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will investigate the efficacy of the Indomethacin patch in pain relief of ankle
      sprain in adult patients, compared to a placebo patch
    

Detailed description: 
      Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) which reduces pain, fever,
      stiffness and swelling in acute skeletal musculature injuries involving joints. However, oral
      Indomethacin formulations predisposes for some systemic side effects. To avoid the systemic
      side effects of oral Indomethacin, a topical Indomethacin formulations have been developed
      and approved in some countries as an Over the counter product. Present study is to
      investigate the efficacy of the Indomethacin patch in pain relief of ankle sprain in adult
      patients.
    

Intervention name(s): Indomethacin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Topical indomethacin; Placebo patch
Intervention MeSH terms: Indomethacin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Safety, Tolerability and Pharmacokinetics After Continuous Infusion of KAND567
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The study was planned to consist of 24 healthy subjects in 3 dosing cohorts receiving a
      continuous i.v. infusion of KAND567 or placebo for 6 h (6 subjects on active and 2 subjects
      on placebo per cohort), with the option of two additional cohorts of the same size and group
      composition.
    

Detailed description: 
      The 3 planned dose levels of KAND567 were based on preliminary data from previous i.v.
      infusions and were chosen to obtain approximate Css levels of 0.5, 1.0 and 2.0 μM. The dose
      levels were 33.8 mg/6 h (cohort 1), 67 mg/6 h (cohort 2), or 134 mg/6 h (cohort 3).

      Each cohort of participants was planned to consist of 8 subjects (2 on placebo and 6 on
      active drug), i.e. a total of 24 subjects. A sentinel approach was used for all three
      cohorts, starting dosing with two subjects (one on active drug, one on placebo). If safe and
      tolerable, an additional two or three subjects will be administered. If safe and tolerable,
      the remaining three or four subjects of the cohort were dosed. There was an evaluation of
      safety and tolerability from the previous cohort prior to proceeding to the next cohort.
    

Intervention name(s): KAND567; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Continuous intravenous infusion for 6 hours; Continuous intravenous infusion for 6 hours
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Energy Metabolism and Cost of Physical Activities Using Whole Body Calorimeter
Condition: Energy Regulation
Study type: Observational

Summary: 
      The aim of this study is to assess energy regulation of overfeeding and performing common
      household activities in young Chinese males using whole-body room calorimetry up to 10 hours.
    

Detailed description: 
      This study will require participants to stay in the room calorimeters for up to 5 hours on
      each of the 3 test sessions. The participants are to avoid intense physical activity/alcohol
      and to record their food intake for the day prior to test day. They will record their food
      intake for the day prior to test session 1 in a food diary (to be provided to them on the day
      of screening). Records will be used to ascertain participants' food intake patterns. They
      will report to Clinical Nutrition Research Centre (CNRC) in the morning after an overnight
      (10-12 hours) fast. Basic anthropometric measurements will be taken at the start of the test
      session before participants enter the room calorimeter. The room calorimeter is a 13.5 m3
      chamber furnished with features to give an impression of a normal room with windows on three
      sides of the chamber for outside view and visual contact with researchers. It has a full
      sized foldaway bed, a fold-down writing table, an office chair, a built-in sink and mirror, a
      portable freeze-dry toilet bowl, a television, a telephone, computer network connection, an
      intercom system. During their stay in the room calorimeter, energy expenditure will be
      measured based on recorded oxygen consumption and carbon dioxide production over 10 hours.
      Participants are allowed to rest, sit and move freely, except sleep or exercise during their
      stay. On each of the 3 test sessions, the subjects will perform up to 4 common household
      activities (e.g. mopping floor, washing dishes, etc) 1 hour after consuming the light
      breakfast. On test session 1, the light breakfast consist of biscuits and a juice drink and
      will be provided to the participants after they have undergone assessment of metabolism at
      rest for approximately 45 minutes in the room calorimeter. On test session 2 and 3, the same
      light breakfast will be provided after approximately 15 minutes after they have entered the
      room calorimeter. During their 4-5 hours stay in the room calorimeter, they will simulate a
      particular household activity for up to 20 minutes and rest for 30 minutes before continuing
      with another household activity and so on for up to 4 different household activities at each
      of the test sessions.
    

Sampling method: Non-Probability Sample
Study population: 
        Male healthy subjects who are of Chinese ethnicity
Methotrexate Compared With Paclitaxel in Treating Patients With Advanced Head and Neck Cancer
Condition: Head and Neck Cancer
MeSH terms: Head and Neck Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. It is not yet known whether methotrexate or paclitaxel is more
      effective in treating patients with advanced head and neck cancer.

      PURPOSE: Randomized phase III trial to compare the effectiveness of methotrexate with that of
      paclitaxel in treating patients who have advanced head and neck cancer that cannot be treated
      with cisplatin.
    

Detailed description: 
      OBJECTIVES: I. Compare the progression free survival, median survival, and overall survival
      in cisplatin-ineligible patients with advanced squamous cell carcinoma of the head and neck
      following weekly outpatient methotrexate (arm I) versus paclitaxel (arm II). II. Compare the
      response rate of patients in the two treatment arms. III. Compare the Trial Outcome Index
      scores of patients in the two treatment arms. IV. Compare the weight change, neurologic
      toxicity, and mucositis scores of patients in the two treatment arms.

      OUTLINE: This is a randomized study. Patients are stratified by performance status (0-1 vs 2)
      and age (less than 60 vs at least 60). Patients are randomized to receive methotrexate IV
      bolus every week for 4 weeks (arm I) or paclitaxel IV over 1 hour every week for 4 weeks (arm
      II). All patients receive at least 4 weeks of treatment (1 course). Patients continue
      treatment for a total of 6 courses in the absence of disease progression or unacceptable
      toxicity. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and
      annually thereafter.

      PROJECTED ACCRUAL: There will be 230 patients accrued into this study over 2.4 years.
    

Intervention name(s): methotrexate; paclitaxel
Intervention type(s): Drug; Drug
Intervention MeSH terms: Paclitaxel; Methotrexate
Allocation: Randomized
Primary purpose: Treatment
Keywords: stage IV salivary gland cancer; recurrent salivary gland cancer; salivary gland squamous cell carcinoma; stage IV squamous cell carcinoma of the lip and oral cavity; recurrent squamous cell carcinoma of the lip and oral cavity; stage IV squamous cell carcinoma of the oropharynx; recurrent squamous cell carcinoma of the oropharynx; stage IV squamous cell carcinoma of the nasopharynx; recurrent squamous cell carcinoma of the nasopharynx; stage IV squamous cell carcinoma of the hypopharynx; recurrent squamous cell carcinoma of the hypopharynx; stage IV squamous cell carcinoma of the larynx; recurrent squamous cell carcinoma of the larynx; stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity; recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity
Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 113823 Powder in Bottle (PiB) and Tablet in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate the safety, tolerability, and pharmacokinetics incl. dose proportionality of
      BI 113823, as well as the relative bioavailability of PiB vs. tablet and tablet fasted vs.
      fed (food effect for the tablet).
    


Intervention name(s): BI 113823 solution; BI 113823 tablet; Placebo; High fat, high calorie breakfast
Intervention type(s): Drug; Drug; Drug; Other
Intervention description(s): only for dose group 5
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Uses of Irradiated Human Amniotic Membrane in the Treatment of Dystrophic Epidermolysis Bullosa Patients
Condition: Epidermolysis Bullosa; Chronic Skin Ulcer
MeSH terms: Epidermolysis Bullosa; Epidermolysis Bullosa Dystrophica; Skin Ulcer
Study type: Interventional

Summary: 
      To evaluate the effect of human amniotic membrane as a weekly dressing on chronic wounds in
      Epidermolysis Bullosa (EB) patients.
    

Detailed description: 
      Dried human amniotic membrane dressing were obtained from National center for radiation
      research and technology, Egypt (NCRRT), under commercial name REGE pro.
    

Intervention name(s): REGE pro dressing
Intervention type(s): Biological
Intervention description(s): REGE pro is a dressing of dried human amniotic membrane sterilized by gamma radiation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Epidermolysis Bullosa; Amniotic membrane