bioihbjkbjnl/mcl2 huggingface dataset:
Periodontal Treatment Associated With Hyperbaric Oxygen Therapy
Condition: Periodontal Disease
MeSH terms: Periodontal Diseases
Study type: Interventional

Summary: 
      Evaluation of the clinical effect of hyperbaric oxygen therapy (HBOT) adjunctively to scaling
      and root planing (SRP) in the treatment of severe case of chronic periodontitis.
    

Detailed description: 
      Materials and Methods: In 20 patients diagnosed with severe generalized chronic periodontitis
      (pockets>7mm) with bleeding on probing, SRP was rendered in all pockets. Additionally, five
      consecutive hyperbaric sessions were administered in 10 patients after random allocation
      (SRP+HBOT). Clinical parameters were assessed at baseline up to 6 months: plaque index (PI),
      bleeding on probing, probing depth, clinical attachment level and BANA test.

      Results: SRP+HBOT resulted in greater probing reduction and attachment gain than SRP alone 3
      months after treatment (p<0.001). The BANA test was negative after 1 week only for sites in
      the SRP+HBOT group (p<0.05). However SRP+HBOT failed to show a significant difference from
      SRP group after 3 months were all BANA sites became negative (p>0.05).

      Conclusion: These preliminary data suggest that hyperbaric oxygen therapy had a short-term
      beneficial effect on pocket reduction and bacterial elimination, and may be considered a
      potential therapy option to improve the clinical outcomes of scaling in severe cases of
      chronic periodontitis.
    

Intervention name(s): oxygen; other
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: periodontitis; hyperbaric oxygen therapy
Validation of a Nutrition Screening Tool
Condition: Adenocarcinoma of the Gastroesophageal Junction; Cervical Cancer; Endometrial Cancer; Esophageal Cancer; Fallopian Tube Cancer; Gastric Cancer; Ovarian Cancer; Sarcoma; Vaginal Cancer; Vulvar Cancer
MeSH terms: Endometrial Neoplasms; Fallopian Tube Neoplasms; Vulvar Neoplasms; Vaginal Neoplasms
Study type: Observational

Summary: 
      The objective of this study is to evaluate the sensitivity and specificity of two nutrition
      screening tools to identify inpatients with malnutrition or at risk of malnutrition. The two
      tools are the Royal Marsden Abridged Adult Nutrition Screening Tool (AANST) and the
      Malnutrition Screening Tool (MST)[10] The tools will be compared with the currently accepted
      gold standard, Patient Generated Subjective Global Assessment (PG-SGA). Both screening tools
      are in the form of scored questionnaires and are suitable for electronic input.

      The ultimate objective is to select an adult inpatient nutrition screening tool with the
      highest sensitivity for future use in the oncology inpatient setting in order to allow prompt
      commencement of an appropriate nutrition care plan.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients will be approached for consideration and recruitment to the study in a stratified
        manner in order to proportionately represent the diagnostic groups admitted to The Royal
        Marsden NHS Foundation Trust as inpatients. Patients will be approached sequentially from
        the list until the required number of patients are recruited for that particular diagnoses.
        Recruitment for particular diagnostic groups may take place over a number of days until the
        required number of patients is recruited. The same procedure will be repeated, with a newly
        generated list, for all selected diagnostic groups in a random order. This methodology will
        aim to capture patients who have been newly diagnosed, patients with established disease,
        patients newly admitted and those who have been inpatients for anumber of days or weeks.
An Efficacy and Safety Study of PENTASA in Chinese Patients With Left-sided Active Ulcerative Colitis Followed by a 24-Week Open-Label Extension Phase
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to investigate the efficacy and safety of 4-week double-blind
      treatment with PENTASA enema compared with placebo enema in Chinese patients with mild to
      moderate active left-sided ulcerative colitis, followed by a maximal 28-week open-label
      extension phase with PENTASA enema and/or PENTASA tablets.
    


Intervention name(s): Mesalazine Enema; Placebo Enema
Intervention type(s): Drug; Drug
Other intervention name(s): PENTASA® Enema
Intervention MeSH terms: Mesalamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
To Evaluate the Effect of AZD1722 on the Pharmacokinetics of Oral Midazolam in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      A Study to Evaluate the Effects of oral repeated doses of AZD1722 on the Pharmacokinetics of
      Oral Midazolam in Healthy Volunteers
    

Detailed description: 
      A Phase 1, Single-center, Fixed-sequence, Open Label Study to Evaluate the Effect of Oral
      Repeated Doses of AZD1722 on the Pharmacokinetics of Oral Midazolam in Healthy Volunteers
    

Intervention name(s): Midazolam; AZD1722; AZD1722 and Midazolam
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Volunteers will receive a single dose of Midazolam 7.5 mg on Day 1; Volunteers will receive twice daily, oral doses of AZD1722 15 mg on Days 2-14; On Day 15 volunteers will receive AZD1722 15 mg and Midazolam 7.5 mg at the same time in the morning. In the evening on Day 15 AZD1722 15 mg will be administered alone.
Intervention MeSH terms: Midazolam
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Phase I; Healthy; Pharmacokinetics
Effects of Melatonin on Sleep, Ventilatory Control and Cognition at Altitude.
Condition: Altitude Hypoxia; Ventilation; Sleep; Oxidative Stress; Neurocognitive Dysfunction
MeSH terms: Altitude Sickness; Hypoxia; Cognitive Dysfunction
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Low oxygen at altitude causes pauses in breathing during sleep, called central sleep apnea.
      Central sleep apnea causes repeated awakenings and poor sleep. Low oxygen itself and the
      induced oxidative stress can damage mental function which is likely worsened by poor sleep.
      Reduced mental function due to low oxygen can pose a serious danger to mountain climbers.
      However there is also mounting evidence that even in populations of people that live at high
      altitudes and are considered adapted, low oxygen contributes to reductions in learning and
      memory. Therefore there is a serious need for treatments which may improve sleep, control of
      breathing and mental function during low oxygen. Melatonin is a hormone produced in the brain
      during the night which regulates sleep patterns with strong antioxidant and anti-inflammatory
      properties. A study previously reported that melatonin taken 90 mins before bed at 4,300 m
      (14,200 ft) induced sleep earlier, reduced awakenings and improved mental performance the
      following day. However how melatonin caused these effects was not determined. Therefore this
      study aims to determine how melatonin effects control of breathing, sleep and mental
      performance during exposure to low oxygen.
    


Intervention name(s): Melatonin; Hypoxia
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Dietary supplement melatonin; Sleep in a hypoxic tent simulating high altitude
Intervention MeSH terms: Melatonin
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized, double-blind, placebo controlled
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Melatonin; Altitude; Sleep; Ventilation; Cognition
Weight Watchers Online 2015
Condition: Obesity; Overweight; Body Weight
MeSH terms: Overweight; Body Weight
Study type: Interventional

Summary: 
      The purpose of this study is to conduct a randomized controlled trial to compare the weight
      losses produced by the Weight Watchers Online program revised for 2015 (WWO2015) and WWO2015
      plus the provision of an electronic scale and weekly email feedback on weight loss (WWO2015
      Enhanced), over a 6-month period.
    


Intervention name(s): Weight Watchers Online 2015 Program; Electronic Scale with Feedback
Intervention type(s): Behavioral; Other
Intervention description(s): Access to the Weight Watchers Online 2015 program available via the Internet on personal computers, tablet computers, and/or smartphones already owned by participants.; Provision of an electronic scale that automatically transmits body weights to the Weight Watchers Online 2015 program, which generates a weekly feedback message on weight loss progress.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Placebo and Active Controlled, Double Dummy Study to Compare Efficacy of Aspirin and Ibuprofen in Treatment of Episodic Tension-type Headache
Condition: Headache; Tension-Type Headache; Tension-Type Headache (Episodic)
MeSH terms: Tension-Type Headache; Headache
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine the efficacy and tolerability of 500 mg and 1000 mg
      Aspirin® (study medication) by comparing it to placebo (the control group without active
      substance) or 200 mg or 400 mg Ibuprofen (study medication) in treating the symptoms of
      episodic tension-type headache. The study is designed to develop a treatment method against
      episodic tension-type headache which will have more advantages for patients than the methods
      that are currently available.
    


Intervention name(s): Acetylsalicylic acid (Aspirin, BAYE4465); Acetylsalicylic acid (Aspirin, BAYE4465); Ibuprofen; Ibuprofen; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Acetylsalicylic acid 500 mg orally, single dose, 1 tablet; in addition, 1 Placebo tablet of Acetylsalicylic acid, and 2 Placebo tablets of Ibuprofen; Acetylsalicylic acid 2 x 500 mg orally, single dose, 2 tablets; in addition, 2 Placebo tablets of Ibuprofen; Ibuprofen 200 mg orally, single dose, 1 tablet; in addition, 1 Placebo tablet of Ibuprofen, and 2 Placebo tablets of Acetylsalicylic Acid; Ibuprofen 2 x 200 mg orally, single dose, 2 tablets; in addition, 2 Placebo tablets of Acetylsalicylic Acid; 2 Placebo tablets of Acetylsalicylic Acid, and 2 Placebo tablets of Ibuprofen, orally, single dose
Intervention MeSH terms: Aspirin; Ibuprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Methodology Study to Assess Muscle Damage After Eccentric Exercise
Condition: Tendon Injuries
MeSH terms: Tendon Injuries
Study type: Interventional
Phase: Phase 1

Summary: 
      An isolated bout of unaccustomed maximal eccentric exercise is associated with muscle force
      loss for 2-4 days, mild reversible muscle tenderness, and ultra-structural damage to the
      muscle fibers, elevation of muscle proteins in serum, and a detriment in range of motion.
      This single center, pilot study is designed to optimize conditions for the robust measurement
      of functional deficits after muscle damage and to identify markers of repair over 22 days to
      inform future intervention studies. The primary measure will be limb force (assessed
      electronically from the ergometer), previous studies have demonstrated that functional
      measures return fairly rapidly, usually between 2-4 days. Additionally, several biomarkers of
      muscle function will be measured over 22 days, as well as changes in protein synthesis in
      biopsy samples Deuterium-labelled water (D2O) will be consumed by all study participants from
      Day-3 through Day 22 to aid in quantifying newly synthesized proteins.
    


Intervention name(s): Eccentric exercise
Intervention type(s): Other
Intervention description(s): Each subject will perform eccentric exercise against a predefined personal maximal strength of their non-dominant leg on day 1. Changes on strength, biomarker concentrations and muscle protein synthesis during damage and recovery will be measured over 22 days.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Muscle function, Muscle damage and recovery, Eccentric exercise, Muscle soreness, Protein synthesis
Cancer Survival Through Weight Loss and Exercise
Condition: Breast Cancer Survivors
MeSH terms: Weight Loss
Study type: Interventional

Summary: 
      To test the effectiveness and feasibility of intensive motivational, behavior modifying
      intervention aimed at improving physical activity and dietary habits to produce at least 7%
      weight loss in women with a history of breast cancer in a community health setting.
    

Detailed description: 
      This study will be divided into two phases (Phase I and II) that will differ by the intensity
      of motivational intervention. In Phase I, participants will receive 6 months of intensive
      weekly group-based or telephone-based motivational, behavior modifying intervention aimed at
      improving physical activity levels and dietary habits. Phase II will be an additional 6
      months of monthly individualized motivational intervention in order to attain and maintain at
      least 7% body weight loss. All participants will attend an orientation, 2 run-in sessions,
      and a baseline assessment prior to the intervention. Participants will then be assigned to
      either the group based intervention or telephone intervention. The first 30 participants will
      enter into the group-based intervention and the second 30 will enter into the telephone-based
      intervention. Follow-up visits will be completed at the end of Phase I (week 25) and Phase II
      (week 50). Up to 60 women with a previous history of breast cancer will participate in this
      study.
    

Intervention name(s): Group-based Intervention; Telephone-based Intervention
Intervention type(s): Behavioral; Behavioral
Intervention description(s): compared effects of a group-based intervention on weight loss and physical activity.; compared telephone-based intervention to weight loss and physical activity.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Breast Cancer; Weight loss; Group Intervention; Telephone Intervention
Effect of Oxidized Plant Sterols on Serum Concentrations of Plant Sterol Oxidation Products (POP)
Condition: Healthy
Study type: Interventional

Summary: 
      The study is a randomised, double-blind, placebocontrolled, parallel dose-response study with
      four study arms. Sixty subjects will be randomly allocated to consume study products
      containing varying amounts of plant sterol (PS) oxidation products (POP) or placebo for 6
      weeks.
    


Intervention name(s): cookies enriched with POP
Intervention type(s): Other
Intervention description(s): Cookies
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Human Milk for Congenital Gastrointestinal Disorders
Condition: Congenital Gastrointestinal Disorders
MeSH terms: Gastrointestinal Diseases; Digestive System Diseases
Study type: Interventional

Summary: 
      This study aims to identify whether an exclusive human milk diet (EHMD) would improve
      outcomes in neonates with congenital gastrointestinal disorders (CGD) and by facilitating an
      earlier transition off of parenteral nutrition (PN).
    

Detailed description: 
      Infants born with congenital gastrointestinal disorders (CGD) can be very challenging to
      treat. The CGD require surgery shortly after birth to correct the problems and recovery can
      take a long time.

      During the period of time the infant's intestines are sick or don't work properly, they rely
      on parenteral nutrition (IV fluids containing carbohydrates, proteins and fats) to meet their
      nutritional needs. Being on PN for a long time requires special intravenous lines, and
      increases the risk of blood stream infections and can make the liver sick.

      Feeding babies who have these CGD is often very difficult, as the intestine needs to adapt.
      It needs to make appropriately formed stool to eliminate wastes, but not lose too much water
      or too many electrolytes. There is often a lot of starting and stopping of feeds. Human milk
      (HM) is considered the ideal source of nutrition for all infants.

      This study aims to identify whether an exclusive human milk diet (EHMD) would improve
      outcomes in neonates with congenital gastrointestinal disorders (CGD) and by facilitating an
      earlier transition off of parenteral nutrition (PN).
    

Intervention name(s): Human Milk
Intervention type(s): Other
Intervention description(s): Participants will receive an exclusive human milk diet comprised of mother's own milk (MOM, pasteurized donor human milk (DM) fortified with a donor-milk based fortifier (DMBF): Prolact+ for infants <37 weeks PMA and/or or weight <2,200g or PBCLN-002 for infants >37 weeks PMA and/or weight >2,200g)
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Digestive Disease and Disorders; Neonatal; Pediatric Disorders
Serum Kisspeptin Levels in Infertile Women
Condition: Infertility, Female; Unexplained Infertility; Anovulation
MeSH terms: Infertility; Infertility, Female; Anovulation
Study type: Observational

Summary: 
      The study population is comprise of 90 women those age varies between 18-38 year-old. The
      first group will comprise of 30 women with polycystic ovaries or anovulatory cycles, the
      second group will comprise of 30 women with diagnosis of unexplained infertility and the
      third group will comprise of 30 women those partners with male subfertility. A 2 cc blood
      sample for Kisspeptin analysis will be drawn from the antecubital vein from each
      participants. The patients will receive 50 mg clomiphene citrate at the fifth day of the
      menstrual period and follicular development will be measured with serial ultrasound follow
      up.
    

Detailed description: 
      The study population is comprise of 90 women those age varies between 18-38 year-old with
      wish of baby for at least one year despite of unprotected sexual intercourse, patent tubes
      confirmed in hysterosalpingography , follicle stimulating hormone levels <12 IU. The first
      group will comprise of 30 women with polycystic ovaries in ultrasound examination or
      anovulatory cycles, the second group will comprise of 30 women with diagnosis of unexplained
      infertility, normal menstrual periods and without known male factor infertility and the third
      group will comprise of 30 women those partners with sperm count between 5x106 -15x106 /mL,
      type A + type B motility <%32 and Kruger morphology <4%. A 2 cc blood sample for Kisspeptin
      analysis will be drawn from the antecubital vein from each participants and centrifuged and
      sera will be kept in -80 C till recruitment has been completed. Kisspeptin, E2, Progesterone,
      anti-mullerian hormone levels will be measured with ELISA method. The patients will receive
      50 mg clomiphene citrate at the fifth day of the menstrual period and follicular development
      will be measured with serial ultrasound follow up.
    

Intervention name(s): Blood sample
Intervention type(s): Other
Intervention description(s): Serum analysis
Other intervention name(s): Serum Kisspeptin levels
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        90 infertile female women those with infertile couples due to anovulation,male sub
        fertility and unexplained infertility.
Phase II Clinical Study to Assess the Efficacy and Safety of Nemonoxacin Malate in Treating Adult Patients With Community-acquired Pneumonia (CAP)
Condition: Community-acquired Pneumonia
MeSH terms: Pneumonia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety, tolerability and population
      pharmacokinetics of oral nemonoxacin in community-acquired pneumonia (CAP) subjects.
    

Detailed description: 
      Evaluate clinical efficacy, microbiological efficacy and safety of Nemonoxacin adult patients
      with community-acquired pneumonia (CAP); and

      A study on the population pharmacokinetics (PPK) of continuous oral administration of
      Nemonoxacin in adult patients with CAP.
    

Intervention name(s): Levofloxacin 500 mg placebol; Levofloxacin 500 mg placebol; Nemonoxacin 3 tablets
Intervention type(s): Drug; Drug; Drug
Intervention description(s): oral form,,once adily,7~10 days; oral form,,once adily,7~10 days; oral form,once daily,7~10 days
Intervention MeSH terms: Levofloxacin; Ofloxacin; Nemonoxacin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: CAP