bioihbjkbjnl/mcl2 huggingface dataset:
Lockdown Impact on Spontaneous Premature Birth in a Level III NICU
Condition: Premature Birth; Preterm Labor
MeSH terms: Premature Birth; Obstetric Labor, Premature
Study type: Observational

Summary: 
      Preterm labor (PL) is the leading cause of hospitalization during pregnancy and premature
      birth the leading cause of fetal morbidity and mortality in France. PL is defined by regular
      and painful uterine contractions associated with a change in the cervix, between 22 and 36
      weeks of gestation.

      It has been shown that the risk of spontaneous prematurity increases particularly in case of
      working over 40 hours per week, hard physically conditions, or prolonged daily transport
      time. Rest is one of the most efficient measure to prevent PL and should be proposed to all
      pregnant women, and combined with other therapies such as tocolysis or cerclage when needed.

      The very particular period of lockdown during the COVID-19 pandemic had pregnant women to
      drastically reduce their activity. They suspended their work and stayed home for various
      reasons such as pregnancy in progress, children at home, and also collective reasons such as
      teleworking or workplace closure.

      During the lockdown period from March 17th to May 11th 2020, fewer preterm labor and less
      spontaneous prematurity have been suspected by the neonatology and obstetrics teams
      throughout the Lorraine region.

      Our study aims to objectively confirm this observation. In this investigation we aim to find
      a relationship between lockdown, PL and spontaneous prematurity which would need to
      re-evaluate public health recommendations for pregnant women outside the lockdown.
    


Intervention name(s): hospitalization for premature birth
Intervention type(s): Other
Intervention description(s): Number of inborn and outborn infants prematurely born during a specific period of time
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        All premature newborns born before 37 SA and care for by the level III NICU of the
        Maternité Régionale Universitaire de Nancy, over time periods from March 1 to June 1 of the
        years 2015 to 2020.
Role of Milk Fat Globule Membranes in Dairy Foods: Health Effects in Humans
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional

Summary: 
      Investigate the effects of milk fat with or without milk fat globule membranes (MFGM) on
      blood lipid profile, vascular function, insulin sensitivity, inflammation and gene
      expression. Overweight subjects will be randomized to one of 2 groups with different types of
      dairy products: 1)butter oil; 2) cream (milk fat with MFGM).
    

Detailed description: 
      Dairy foods are a major component of the nordic diet. Epidemiological data suggest potential
      health effects of dairy foods with regard to obesity related disorders. Low-fat dairy foods
      have shown to be protective, but also high-fat products have been linked to reduced risk in
      some studies. It is well known that dairy products increase LDL-cholesterol in blood, but
      effects on glucose metabolism are unclear. Intervention trials are needed to clarify the
      health effects of dairy foods. Some data have indicated that cheese and milk may have less
      hypercholesterolemic effect compared with butter. Our hypothesis is that milk fat globule
      membranes (MFGM), present in all dairy products except butter, can affect blood lipid
      profile, vascular function, insulin sensitivity, inflammation and gene expression. Such idea
      might explain why different dairy products could have different effects on cholesterol
      levels. The investigators aim to conduct a controlled study to investigate this. Overweight
      subjects will be randomized to one of 2 groups with different types of dairy products:
      1)butter oil; 2) cream (milk fat with MFGM).
    

Intervention name(s): Butter oil; Cream
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Daily intake of 40 g butter oil; Daily intake of 100 g cream (40%)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Saturated fat; Dairy products; Milk fat globule membrane; Cholesterol; Butter; Cream
In Vivo Investigation of Novel Nano-vesicles of Salbutamol Sulphate
Condition: Drug Effect; Pulmonary Disease
MeSH terms: Lung Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The relative bioavailability of different salbutamol sulphate inhaler formulations will be
      studied in healthy male subjects according to the ethical regulations of World Medical
      Association Declaration of Helsinki (1996) after the approval of the ethical committee,
      Faculty of Pharmacy, The British University in Egypt.
    

Detailed description: 
      In this study, 20 healthy, non smoking, adult male volunteers (age: 30-45 years, weight:
      65-80 kg) will carry out screening procedures which include instruction and practice with the
      placebo metered dose inhaler devices that will be used in the study. In addition, all
      subjects were fully informed in writing of the objectives and implications of the trial. No
      subject will be considered for the study if developed any symptoms of allergic disorders.
      Subjects will follow a normal diet and will not receive any other medications. Volunteers
      will be divided into two groups; each group contained 10 volunteers who will receive one
      formula of the selected formulae.

      Each volunteer will inhale eight puffs (4 puffs at -5 min & 4 puffs at 0 min) which are
      equivalent to 0.8 mg of salbutamol sulphate . To inhale through metered dose inhalers,
      volunteers will be trained to exhale slowly to their residual volume (as far as comfortable),
      put the inhaler into their mouth and seal their lips round the mouth piece. Then they will be
      instructed to take a slow deep inspiration to their total lung capacity over approximately
      5-10 seconds. At the end of each inhalation, they will hold their breath for 10 seconds and
      then breathe normally (Ball et al, 2002) . Three milliliters of blood will be withdrawn at 0,
      0.5, 1, 2, 3, 4, 5 and 6 h after administration. The blood will be heparinized immediately
      and centrifuged at 3000 rpm for 10 minutes. The plasma samples will be stored at freeze
      temperature until analysis. Two different formulae will be compared during the first six
      hours following administration. The maximum plasma concentration (Cmax), the time required to
      reach maximum plasma concentration (Tmax) and the area under plasma concentration time curve
      (AUC) will be calculated using validated Excel software.
    

Intervention name(s): Salbutamol Sulphate; Niosomes
Intervention type(s): Drug; Drug
Intervention description(s): salbutamol sulphate packaged as aerosol; Niosomes
Other intervention name(s): nano-vesicles
Intervention MeSH terms: Albuterol
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Volunteers will be divided into two groups; each group contained 10 volunteers who will receive one formula of the selected formulae.
Masking: None (Open Label)
Primary purpose: Treatment
Pilot Study to Evaluate Efficacy of Botanical Extracts as Protein Amplifier for Skeletal Muscle Strength & Growth.
Condition: Muscle Strength
Study type: Interventional

Summary: 
      Sponsor proposes ingredients that when added to daily whey supplementation, can lead to
      increased muscle strength, improves sleep quality and reduction in fatigue level.
    

Detailed description: 
      The present study is a randomized, blinded, placebo-controlled, pilot study. Approximately 40
      males aged between ≥ 20 and ≤ 35 years, will be screened. Each trial arm will have at least 5
      completed after accounting for dropout/withdrawal rate of 20%. The treatment duration for all
      the study participants will be 28 to 56 days (Day 56 is only applicable for participants with
      less than 10% increase in weight leg pressed for 1 RM on Day 28. All participants in arm 1 of
      study will have their end of study visit on Day 28).Sponsor proposes ingredients that when
      added to daily whey supplementation, can lead to increased muscle strength, improves sleep
      quality and reduction in fatigue level.
    

Intervention name(s): Placebo without Exercise; Placebo with Exercise; IP I; IP II; IP III
Intervention type(s): Other; Other; Other; Other; Other
Intervention description(s): 2 Capsules to be taken 30 minutes before breakfast.; 2 Capsules to be taken 30 minutes before breakfast.; 2 Capsules to be taken 30 minutes before breakfast.; 2 Capsules to be taken 30 minutes before breakfast.; 2 Capsules to be taken 30 minutes before breakfast.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Arm 1 (Placebo without Exercise) Arm 2 (Placebo with Exercise) Arm 3 (IP I) Arm 4 (IP II) Arm 5 (IP III)
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Strattera Treatment in Children With ADHD Who Have Poor Response to Stimulant Therapy
Condition: ADHD
Study type: Interventional
Phase: Phase 4

Summary: 
      This will be a 6-week, unblinded study using the medication Strattera for children and
      adolescents with attention deficit hyperactivity disorder (ADHD) who failed to respond to an
      adequate trial of stimulant treatment. Specific hypotheses are as follows:

      Hypothesis 1: ADHD symptomatology in youth with ADHD will be responsive to Strattera
      treatment in the short term.

      Hypothesis 2: Strattera treatment (in doses of up to 120 mg/day or 1.2 mg/kg/day) in children
      and adolescents with ADHD will be safe and well tolerated.
    

Detailed description: 
      Strattera (atomoxetine) is a non-stimulant presynaptic norepinephrine reuptake inhibitor
      recently approved by the Food and Drug Administration for use in child, adolescent and adult
      patients with ADHD. Atomoxetine is a potent inhibitor of the presynaptic norepinephrine
      transporter with minimal affinity for other noradrenergic receptors or for other
      neurotransmitter transporters or receptors. Thus, Strattera could be a viable alternative
      treatment for ADHD individuals who do not respond to stimulants.

      The purpose of this study is to assess the effectiveness, safety and tolerability of
      Strattera in youth, ages 6-17 years with ADHD who failed to respond to an adequate trial of
      stimulant treatment. If this initial study shows proof of the concept, we will follow-up the
      study with a randomized clinical trial.
    

Intervention name(s): atomoxetine (Strattera)
Intervention type(s): Drug
Intervention MeSH terms: Atomoxetine Hydrochloride
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ADHD; children; stimulant non-responders; Strattera
Circulating-water Garment With Forced-air Warming and Circulating-water Mattress During Abdominal Surgery
Condition: Hypothermia
MeSH terms: Hypothermia
Study type: Observational

Summary: 
      The purpose of this study is to see if the combination of a circulating water mattress
      beneath the patient combined with forced air warming over top of the patient will prevent
      hypothermia (low body temperature) just as well as a garment that circulates warm water
      around the patient, during your major abdominal surgery. Patients will be randomly assigned
      to one of these two groups.
    

Detailed description: 
      Group A: This group will receive the circulating water garment Group B: This group will
      receive the circulating water mattress and be covered by a forced air warming device for both
      the upper body and lower body

      Once the patient is moved to the operating room table, the surface of the back will begin to
      be warmed using either the circulating-water garment for those in Group A or the
      circulating-water mattress for those in Group B. Following the start of anesthesia,
      additional warming will be done by covering the large parts of the legs and the upper and
      side of the chest using either the circulating-water garment for those in Group A or upper-
      and lower-body forced-air warmers for those in Group B.

      Patient involvement will last until the warming devices are removed prior to departure from
      the operating room. There is no follow-up to this study.
    

Observational model: Cohort
Sampling method: Probability Sample
Study population: 
        Male or female patients between 18-85 years of age who are undergoing major abdominal
        surgery who do not have a contradiction to forced-air or circulating water warming.
        Patient's undergoing combined procedures are not eligible to participate. Patient can not
        have a core temperature over 38°C, be pregnant or
      
Keywords: abdominal surgery; hypothermia; circulating water mattress
Human Beta-2 Adrenergic Stimulation and Muscle Glucose Uptake
Condition: Healthy
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to investigate the effect of two weeks clenbuterol/placebo
      supplementation on skeletal muscle glucose disposal in healthy male volunteers.
    


Intervention name(s): Clenbuterol Hydrochloride; Placebos
Intervention type(s): Drug; Drug
Intervention description(s): Daily ingestion of clenbuterol hydrochloride capsules (40 microgram/day) for a total period of 14 days with a wash-out period of 4 weeks.; Daily ingestion of placebo capsules for a total period of 14 days with a wash-out period of 4 weeks.
Intervention MeSH terms: Clenbuterol
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized, double-blinded, placebo-controlled, cross-over, single-center study
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Beta-2 adrenergic agonist; Glucose homeostasis; Skeletal muscle; Human
A Trial of Nature-based Post-stroke Fatigue Rehabilitation (NASTRU)
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      The aim of NASTRU was to examine whether ten weeks of nature-based rehabilitation, as add-on
      to standard management, could influence post-stroke fatigue (primary outcome), depression,
      work ability or functional outcome (secondary outcomes), compared to controls.
    

Detailed description: 
      Patients randomized to the intervention undergo a rehabilitation program in groups up to 8
      patients in an especially designed garden at the Swedish University of Agricultural Sciences,
      Alnarp. The intervention is grounded in environmental psychology and occupational therapy,
      supported by a multimodal rehabilitation team that utilizes the garden/nature for sensory
      stimulation, body awareness, meaningful occupations and nature experiences.

      The enrollment of 101 patients (51 intervention; 50 control) was completed on August 2014.
      Follow-up is on-going, with assessments by examiner blinded to treatment group, at end of
      intervention period, 8 months, and 14 months after randomization. A parallel study with
      qualitative in-depth interviews in a subset of patients, who were randomized to the
      intervention group, as well as the staff, is also ongoing.
    

Intervention name(s): Nature based rehabilitation; standard management after stroke
Intervention type(s): Other; Other
Intervention description(s): ten weeks of nature-based rehabilitation, as add-on to standard management. A rehabilitation program in groups up to 8 patients in an especially designed garden at the Swedish University of Agricultural Sciences, Alnarp. The intervention was grounded in environmental psychology and occupational therapy, supported by a multimodal rehabilitation team that utilized the garden/nature for sensory stimulation, body awareness, meaningful occupations and nature experiences.; standard management after stroke is individualised.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Single Ascending Dose Study With 5-MeO-DMT in Healthy Subjects
Condition: Pharmacokinetics in Healthy Adults
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will evaluate safety, tolerability and PK profile of 5-MeO-DMT in healthy subjects
    


Intervention name(s): 5-MeO-DMT; Placebo
Intervention type(s): Drug; Other
Intervention description(s): A single dose of 5-MeO-DMT will be administered intranasally; A single dose of placebo will be administered intranasally
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effect of TEAS on the Incidence Rate of SIRS in Patients Undergoing Abdominal Surgery
Condition: Systemic Inflammatory Response Syndrome; Inflammation
MeSH terms: Syndrome; Inflammation; Systemic Inflammatory Response Syndrome
Study type: Interventional

Summary: 
      The purpose of this study is to access the effect of Transcutaneous Electrical Acupoint
      Stimulation(TEAS) on the Incidence rate of Systemic Inflammatory Response Syndrome (SIRS) in
      patients undergoing radical surgery for gastric cancer
    

Detailed description: 
      Patients undergoing elective radical surgery for gastric cancer under general anesthesia were
      randomly assigned to three groups, control group , TEAS group and sham TEAS group.

      TEAS group receiving TEAS before general anesthesia induction , 1th day and 2nd day after
      surgery. TEAS was given through electrodes attached to specific acupoints. The time for TEAS
      was 30min.

      Sham TEAS group receiving sham TEAS before general anesthesia induction , 1th day and 2nd day
      after surgery. Sham TEAS was given through electrodes attached to non-acupoints. The time for
      sham TEAS was also 30min.

      Control group were given no TEAS. Incidence rates of SIRS in each group were compared .Venous
      blood samples from all groups(control group , TEAS group and sham TEAS group) were collected
      before general anesthesia induction,1th day and 3rd day after surgery. Inflammatory cytokines
      index including interleukin-6,interleukin-10,Tumor Necrosis Factor-
      alpha(TNF-α),Interferon-γ(IFN-γ),Monocyte Chemotactic Protein 1(MCP-1),IgG,IgM were measured.
    

Intervention name(s): TEAS; Sham TEAS
Intervention type(s): Device; Device
Intervention description(s): Electric stimulation was given through electrode attached to specific acupoints for 30mins before general anesthesia induction,1th day and 2nd day after surgery.; Electric stimulation was given through electrode attached to non-acupoints for 30mins before general anesthesia induction,1th day and 2nd day after surgery.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Review of the Paediatric Pleuropulmonary Blastoma French Series
Condition: Pleuropulmonary Blastoma
MeSH terms: Pulmonary Blastoma
Study type: Observational

Summary: 
      Pleuropulmonary blastoma is a rare embryonic malignant tumour that remains the most frequent
      malignant tumour of the lung in childhood. The International Pleuro pulmonary Blastoma
      Registry (IPPB) found only 220 cases in 2009 and 350 in 2015. In France, 20 cases were
      identified in 2009.

      Three histologies are described: type 1 purely cystic, type 2 combined and type 3 solid.
      Median age at diagnostic is 12 months, 35 months and 41 months respectively. Evolution is
      possible from type 1 to type 2 or 3 in 10% of the cases.

      Since 2009, DICER 1 mutations research is proposed systematically to all families.

      PPB symptoms are usually non-specific. Diagnostic is evoked when imaging work up shows
      bubbles or solid lesions, and confirmed by pathological analysis. However the diagnosis can
      be difficult because of the proximity with congenital cystic adenomatoid malformation.

      The French society of paediatric oncology recommends surgery at first instance. PPB type 1
      remains a problem because some are still misdiagnosed as CCAM, a benign lesion. Chemotherapy
      depends on the PPB type and the quality of the resection. There is a real interest to analyse
      the French series.

      The prognosis of type 2 and 3 is low with a 5 years survival rate of 45-60%, whereas type 1
      survival rate is 91%. The French experience reports a 100% survival rate in type 1 and 48% in
      type 2 and 3. Other prognostic factors are initial size of the tumour, extra pulmonary
      invasion and quality of surgery.

      Early local relapses are possible and late ones concern more often type 2 and 3 with more
      cerebral metastasis.

      In 2009, the french cases were collected, but no update has been performed since. The aim of
      this retrospective review of the cases since 2000, is to audit the care of PPB patients in
      France and update the French rare tumour database.

      Evoking PPB diagnosis is difficult when imaging shows a neonatal cystic lesion. There are no
      radiologic criteria in the literature that differentiate congenital pulmonary cystic lesion
      and PPB type 1. Radiological presentation is however overlapping. Another aim of this study
      will be to look for a predictive sign of type 1 PPB.
    

Detailed description: 
      Multicentre retrospective study
    

Intervention name(s): PPB
Intervention type(s): Other
Intervention description(s): Global current care
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients born between 01/01/2000 and 01/01/2016, followed up for PPB, treated in a French
        department of paediatric oncology or paediatric surgery.
Evaluation of the Neoadjuvant Treatment With Oxaliplatin -UFT- Radiotherapy in Rectal Cancer
Condition: Rectal Neoplasms
MeSH terms: Rectal Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Primary objective:

      - To evaluate the rate of responses to neoadjuvant therapy + radiotherapy

      Secondary objective:

      - tolerability (toxicity) and time to progression
    


Intervention name(s): OXALIPLATIN
Intervention type(s): Drug
Intervention MeSH terms: Oxaliplatin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment