bioihbjkbjnl/mcl2 huggingface dataset:
The Effects of Milk and Banana as a Night Meal to Primary Insomnia on Sleep Quality, BDNF and Appetite Mechanism
Condition: Primary Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional

Summary: 
      The aim of this study to determine the impact of banana and milk on sleep and appetite
    

Detailed description: 
      Sleep is one of the main components of the continuity of circadian rhythm. It restores energy
      and enhancement, memory. Sleep disturbances and short sleep duration are important risk
      factors for many diseases. Nutrition is one of the main determinants of health status in many
      diseases related to inflammation. Especially the night meal, known as the foods consumed
      before bedtime, has a strong effect on sleep. Although there are methodological differences,
      most studies show that unhealthy eating habits are associated with short sleep duration. It
      is thought that consuming foods with high tryptophan and melatonin content can reduce sleep
      problems. This study will give a chance to observe the effects of nutrients on sleep and
      appetite mechanisms.
    

Intervention name(s): Banana arm; Milk arm; No intervention
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Venous blood samples will be taken from the participants in 3 groups before starting the study. Pittsburgh Sleep Quality Index will be applied.Food consumption frequency and food-based follow-up will be carried out.Participants will consume 1 portion of banana (gross 80-85 g) given to them for 6 weeks, approximately 45 minutes-1 hour before bedtime. The frequency of food consumption will be taken from the participants each week.; Venous blood samples will be taken from the participants in 3 groups before starting the study. Pittsburgh Sleep Quality Index will be applied. Food consumption frequency and food-based follow-up will be carried out. Participants will consume 200 ml of whole milk given to them for 6 weeks, approximately 45 minutes-1 hour before bedtime. The frequency of food consumption will be taken from the participants each week.; Venous blood samples will be taken from the participants in 3 groups before starting the study. Pittsburgh Sleep Quality Index will be applied. The frequency of food consumption will be taken from the participants each week.Participants are expected not to make any changes in their diet. As in other groups, the frequency of food consumption will be taken from the participants every week in this group. In order to observe the possible changes in the experimental arms, the individuals in the control arm will be asked not to consume bananas and whole milk after 16:00 and they will be informed about this.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: 1. Experimental: Banana arm Experimental: Milk arm Control arm
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: diet; food; BDNF; Appetite
A Pharmacokinetic Study of Tedizolid Phosphate in Pediatric Participants With Gram-Positive Infections (MK-1986-014)
Condition: Gram-Positive Infections
MeSH terms: Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objectives of this study are to describe the single-dose, and multiple dose
      pharmacokinetics (PK) of intravenous (IV) tedizolid phosphate, or a single dose oral
      suspension of tedizolid phosphate, when administered to pediatric participants, full-term
      neonates, and preterm neonates.
    


Intervention name(s): IV Tedizolid Phosphate; Oral Suspension Tedizolid Phosphate
Intervention type(s): Drug; Drug
Intervention description(s): A single dose, or twice daily dose for 3 days, of tedizolid phosphate administered IV.; A single dose of tedizolid phosphate administered as an oral suspension.
Intervention MeSH terms: Tedizolid; Tedizolid phosphate; Oxazolidinones
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Impact of Systematic Infants Vaccination Against Rotavirus on Gastroenteritis Hospitalization: a Prospective Study in Brest District, France.
Condition: Rotavirus Gastroenteritis
MeSH terms: Gastroenteritis
Study type: Interventional
Phase: Phase 4

Summary: 
      Universal rotavirus vaccination program for infants born in Brest after February 2007,
      applied by the Centers for Maternal and Infant Health Protection, pediatricians and general
      practitioners.

      Prospective surveillance of hospitalizations for gastroenteritis within the Pediatric Units
      of Brest University Hospital with systematic testing for Rotavirus.

      Evaluation of the impact of the vaccination program on rotaviral gastroenteritis
      hospitalizations from 2007-2008 and 2008-2009, by comparison with epidemiological data from
      2002-2007 in the absence of vaccination.

      The principal judgement criterion is the number of pediatric hospitalizations for rotaviral
      GEA during the 2008-2009 epidemic in children A) under the age of 2 and B) residing in the
      suburbs of Brest.
    


Intervention name(s): Rotateq vaccine
Intervention type(s): Biological
Intervention description(s): Vaccination against rotavirus
Three oral doses (2 mL) between 6 to 26 weeks of life with at least 4 weeks between each dose.
Other intervention name(s): Rotateq
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: prevention; rotavirus vaccine; gastroenteritis; systematic vaccination; infants; aged 6 to 12 weeks
Effects of Core Stabilization Approach on Patients With Upper Extremity Injuries
Condition: Upper Extremity Injuries
MeSH terms: Arm Injuries
Study type: Interventional

Summary: 
      The purpose of the study is to determine the effects of the addition of core stabilization
      exercises to a traditional upper extremity rehabilitation program in upper extremity
      injuries.
    

Detailed description: 
      Abnormal movement patterns are one of the most challenging problems during rehabilitation of
      the patients with upper extremity injuries. They usually decrease the functional status of
      the upper extremity and prevent isolated muscle activations. Dysfunction of the kinetic chain
      system plays an important role in the development of these movement patterns. Thus,
      multi-segmental rehabilitation strategies has recently gained considerable importance in
      upper extremity rehabilitation. Core stabilization is one of the most popular rehabilitation
      approaches preferred to enhance functional stability of the kinetic chain system and dynamic
      postural alignment during activities. The purpose of this study is to determine the effects
      of core stabilization approach on functional status of the upper extremity and the amount of
      abnormal movement patterns. In addition, the factors affecting the abnormal movement patterns
      will be determined.
    

Intervention name(s): Core Stabilization; Traditional upper extremity rehabilitation
Intervention type(s): Other; Other
Intervention description(s): A 6-week (3 days a week) exercise intervention including progressive core exercises was performed.; A 6-week (3 days a week) exercise intervention of the injured joint based on the recovery process was performed.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: core stabilization, upper extremity, kinetic chain, movement
Does Caffeine Reduce Rosuvastatin-Induced Protection Against Ischemia-Reperfusion Injury?
Condition: Ischemia Reperfusion Injury
MeSH terms: Reperfusion Injury; Ischemia; Wounds and Injuries
Study type: Interventional
Phase: Phase 4

Summary: 
      Does caffeine reduce rosuvastatin induced protection against ischemia reperfusion injury?
    

Detailed description: 
      Rosuvastatin is a proven cholesterol lowering medicine, which hereby is assumed to achieve a
      reduction in cardiovascular events. Apart from it's cholesterol lowering action, rosuvastatin
      may also increase tolerance against ischemia-reperfusion injury. In dogs rosuvastatin
      increases the endogenous concentration of adenosine, by enhancing the activity of the enzyme
      ecto-5'-nucleotidase, which converts adenosine monophosphate into adenosine. We hypothesize
      that rosuvastatin increases tolerance against ischemia-reperfusion injury by induction of
      ecto-5'-nucleotidase and thereby increasing adenosine activity. This protective effect of
      rosuvastatin can be abrogated by using the adenosine receptor antagonist caffeine.
    

Intervention name(s): Rosuvastatin
Intervention type(s): Drug
Intervention description(s): 7 day treatment rosuvastatin 20mg
Intervention MeSH terms: Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Rosuvastatin; Caffeine; Ischemia; Reperfusion
Impact of Synergistic Sequential Treatment (SST)
Condition: Improvement of Wrinkles/Elastosis as Well as General Skin Tone
Study type: Interventional

Summary: 
      At least thirty (30) subjects, Fitzpatrick-Goldman Skin Type II-V will be enrolled in 2
      clinical sites; each clinic will enroll at least 15 subjects.

      Subjects should present visible wrinkles and/or elastosis requiring treatment.

      Hypothesis: The SST will improve the appearance of the wrinkles/elastosis as well as general
      skin tone by at least 25% as compared to M22 ResurFX 1565nm module alone, for at least 75% of
      the subjects.
    


Intervention name(s): M22 ResurFX; M22 ResurFX and QS
Intervention type(s): Device; Device
Intervention description(s): Fractional NA treatment (ResurFX) on one side of the face; Fractional NA treatment followed by QS laser treatment (SST) on one side of the face
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Interdisciplinary Intervention in Patients With Obesity and Other Metabolic Diseases
Condition: Obesity
MeSH terms: Obesity; Metabolic Diseases
Study type: Interventional

Summary: 
      The aim of the research study will be assess the effectiveness of a long-term
      interdisciplinary lifestyle in many aspects including food intake, psychological symptoms,
      physical activity habits, energy expenditure, body composition and anthropometric
      measurements in adults obese.
    

Detailed description: 
      Participants will be recruited after dissemination of the program in the local media and
      internet.

      They will go through a short interview to evaluate inclusion and exclusion criteria. Thus,
      all obese adults will be submitted to an interdisciplinary lifestyle modification therapy
      according the inclusion criteria.

      The interdisciplinary therapy will consist of nutritional, physical exercise, psychological
      and physiotherapy support during the course of one year, according the literature the
      investigators promote a long term therapy to control obesity and metabolic diseases.

      The participants will be evaluated at baseline and after the therapy in accordance with
      Ethical guidelines.

      The main purpose of this therapy is to enhance the quality of life of the participants
      promoting an active lifestyle and quality of life, adherence a healthy nutritional habits and
      a healthy weight loss.

      Our focus will be on teaching strategies to maintain a healthy life style behaviors after
      therapy, our protocol is in agreement with public health field in this way.
    

Intervention name(s): Interdisciplinary Therapy
Intervention type(s): Behavioral
Intervention description(s): The nutrition intervention will consist of group meetings and prescription of individual diets. Participants will have dietary lessons, with information related to the improvement of food consumption and nutritional quality. Exercise program will be focused on improving activity habits, leading to increased energy expenditure. They will undergo training sessions containing aerobic and resistance training. In Psychological program, participants will be monitored in the support group and, if necessary, individual psychological therapy is recommended. The sessions will discuss common psychological aspects commonly associated with obesity (depression, anxiety, stress, family problems, body image, eating disorders and others). The physiotherapy interventions aim to increase functional capacity.
Other intervention name(s): Obesity Treatment; Lifestyle Improvement
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Obesity; Metabolic Syndrome X; Interdisciplinary Studies
Measurement of Gastric Secretion by MRI Under Inhibition by ProtonPump Inhibitors in Healthy Subjects & in GERD Patients
Condition: Gastroesophageal Reflux Disease; Healthy Volunteers
MeSH terms: Gastroesophageal Reflux
Study type: Interventional

Summary: 
      This study bases on the successfully completed project SNF 320000-112006 (EK 1152 and
      SwissMedic 2005dr2207e) and will document the physiological effects of inhibited gastric
      secretion on the volume as well as the acidity of gastric secretion by high dose proton pump
      inhibitors in GERD patients and healthy controls. Twelve participants in each group will be
      studied in a randomized, double-blind placebo controlled trial. A novel non-invasive MRI
      technique developed in Zurich will assess the volume of gastric secretion following the
      ingestion of a regular liquid meal. In addition, intragastric / esophageal pH monitoring will
      assess the link between volume and intragastric distribution of gastric secretion on reflux
      events and symptoms. In addition, the effect of gastric secretion on outcome parameters of a
      non-invasive stable isotope breath test for measurement of gastric emptying will be assessed.
    


Intervention name(s): MRI, non invasive 13C-breath test, 24h-intragastric / esophageal pH monitoring
Intervention type(s): Procedure
Intervention description(s): MRI, non invasive 13C-breath test, 24h-intragastric/esophageal pH monitoring
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A 6-Month Open-Label Extension Study to the B2061014 Study to Evaluate the Safety, Tolerability and Efficacy of DVS SR in the Treatment of Children and Adolescents With MDD
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a 6-month, open-label, flexible-dose study evaluating desvenlafaxine succinate
      sustained release (DVS SR) in the treatment of child and adolescent outpatients with major
      depressive disorder (MDD).
    


Intervention name(s): DVS SR
Intervention type(s): Drug
Intervention description(s): Subjects will receive a flexible-dose of 20, 25, 35 or 50 mg/day as prescribed by the investigator.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Major Depressive Disorder; MDD; Depression
Intervention for the Elderly With Malnutrition, Hidden Hunger and Low Skeletal Muscle Mass
Condition: Malnutrition Risk in Elder
MeSH terms: Malnutrition
Study type: Interventional

Summary: 
      Background: As the aging of the population aggravating, the ratio of the elderly in empty
      nest family has reached 50%, particularly in big and medium size cities, it is as high as
      70%. The elderly in those families where no child living inside, elderly living alone,
      including an individual living alone or living with spouse are known as empty nester. The
      diversity of food consumption of empty nester is always poor, with single and simple meals,
      especially for the consumption of "core food" (fish, meat, egg, milk, vegetables and fruits),
      and the quantity and variety of consumption is very limited, which make the elderly be prone
      to be deficient of high quality protein and micronutrient. In 2005, the World Health
      Organization (WHO) brought up a new concept for the universally exiting problem of vitamin
      and trace elements intake deficiency among people, namely Hidden Hunger. With age increasing,
      multiple causes such as single eating pattern, empty nest lifestyle and chronic diseases lead
      to long term intake deficiency of protein and micronutrient of the elderly, which will
      further result in various symptoms of nutritional deficiency. Therefore, it is particularly
      important for the empty nester to have sufficient energy, high quality protein and multiple
      micronutrients to prevent hidden hunger and sarcopenia, thus avoiding the health problem and
      life quality decreasing caused by them.
    


Intervention name(s): Ensure Complete powder; verbal nutrition education
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Supply the Ensure Complete powder that will be the oral nutrition supplement, with the dose of 6 scoops (53.8 grams) twice daily.Duration: 12 weeks; give the verbal nutrition education
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: the subjects will be randomized into intervention group and control group.
Masking: None (Open Label)
Primary purpose: Treatment
Stress and Sugar Synergy
Condition: Metabolic Syndrome; Insulin Resistance; Dyslipidemia
MeSH terms: Metabolic Syndrome; Insulin Resistance; Dyslipidemias
Study type: Interventional

Summary: 
      The main objectives of this study are to test the hypotheses that: 1) consumption of
      beverages sweetened with sucrose will increase risk factors for cardiovascular disease to a
      greater extent than a naturally-sweetened fruit juice such as orange juice, and 2) chronic
      psychological stress may augment the adverse metabolic effects of sugar intake. The study
      intervention consists of 2-week's consumption of 25% of energy as sugar provided either as a
      sucrose-sweetened beverage or naturally-sweetened orange juice.
    


Intervention name(s): orange juice; sucrose
Intervention type(s): Other; Other
Intervention description(s): intervention assigned: 2-week consumption of naturally-sweetened orange juice providing 25% of energy requirement; intervention assigned: 2-week consumption of sucrose-sweetened beverage providing 25% of energy requirement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: sugar; sucrose; fruit juice; orange juice; metabolism; immune cell aging; lipids
Assessing Electronic Cigarette Nicotine Flux
Condition: Electronic Cigarette Use
Study type: Interventional

Summary: 
      The purpose of this study is to determine differences in nicotine delivery, use behavior,
      carbon monoxide delivery, subjective effects, and physiological effects, when cigarette
      smokers use an electronic cigarette with constant device settings and different e-liquid
      concentrations.
    


Intervention name(s): ECIG Lab Session, 30 watts
Intervention type(s): Other
Intervention description(s): During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The purpose of this study is to determine differences in nicotine delivery, use behavior, (puff topography), and carbon monoxide delivery, subjective effects, and physiological effects, when cigarette smokers use an electronic cigarette with constant device settings and different e-liquid concentrations.
Masking: Single (Participant)
Primary purpose: Basic Science
Child-Parent Psychotherapy for Preschooler Witnesses of Domestic Violence Program
Condition: Domestic Violence Exposure
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will examine the efficacy of Child-Parent Psychotherapy (CPP) for the treatment of
      preschoolers exposed to marital violence.
    

Detailed description: 
      This study examines the efficacy of Child-Parent Psychotherapy (CPP) for the treatment of
      preschoolers exposed to marital violence. Multi-ethnic preschool-mother dyads from diverse
      socioeconomic backgrounds were randomly assigned to CPP or to a case management plus
      community referral for individual treatment comparison group. It was hypothesized the
      children who received CPP treatment would show significantly greater improvement in general
      symptomatology and in traumatic stress symptoms than those in the comparison group.

      There is growing recognition that, contrary to the long-standing assumption that young
      children are impervious to environmental stresses, preschoolers exposed to violence show
      increased rates of disturbances in self-regulation and in emotional, social and cognitive
      functioning (Osofsky, 2004; Pynoos et al., 1999; van der Kolk, 2003). The present study
      examines the efficacy of a relationship-based treatment approach involving the child and the
      mother. Dyads were randomly assigned to either the Child-Parent Psychotherapy (CPP) treatment
      group or to a comparison group that consisted of monthly case management by an experienced
      Ph.D.-level clinician plus referrals for individual treatment in the community for mothers
      and child. We hypothesized that Child-Parent Psychotherapy would be more effective in
      alleviating children's traumatic stress symptoms and behavior problems because it focuses on
      improving the quality of the child-mother relationship and engages the mother as the child's
      ally in coping with the trauma. Treatment was offered for 50 weeks.
    

Intervention name(s): Child-Parent Psychotherapy (CPP)
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: domestic violence; preschoolers; trauma; intervention
Study of Safety, Tolerability and Efficacy of DFV890 in Participants With Familial Cold Auto-inflammatory Syndrome (FCAS)
Condition: Familial Cold Autoinflammatory Syndrome
MeSH terms: Cryopyrin-Associated Periodic Syndromes; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      This is an open-label, single-arm, multiple dose, phase II study to assess safety,
      tolerability and clinical efficacy of DFV890 in participants with FCAS.

      The study includes a screening period, a treatment period and a follow-up period. At most,
      the study will last up to 7 months (and up to 13 months for participants with a historical
      screening cold challenge prior to protocol amendment 04).
    


Intervention name(s): DFV890
Intervention type(s): Drug
Intervention description(s): DFV890
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Familial Cold Auto-inflammatory Syndrome; FCAS; DFV890; NLRP3 inhibitor, inflammasome inhibition; Cryopyrin-associated periodic syndromes; CAPS