bioihbjkbjnl/mcl2 huggingface dataset:
Metabolomic Effects of Probiotics Administration
Condition: Metabolomic Profile
Study type: Interventional

Summary: 
      Background: The establishment of the beneficial interactions between the host and its
      microbiota is essential for the development and correct functioning of the organism, since
      microflora alterations can lead to many chronic degenerative diseases. In this context,
      probiotics are used to improve balanced microbial communities and therefore exert substantial
      health-promoting effects to the host.

      Objective: The aim of the present study is to monitor the molecular outcomes, obtained by gut
      microflora modulation through probiotic treatment, on human urine and serum metabolic
      profiles, with a 1H-Nuclear Magnetic Resonance -based metabolomic approach.
    

Detailed description: 
      Design: In a first phase twenty-two healthy subjects are enrolled in the study and
      administered with Lactobacillus delbrueckii subs. delbrueckii and/or a mix of 5 biotypes of
      Bifidobacterium longum for 8 weeks. In the second phase subjects are enrolled in the study
      and administered with Lactobacillus rhamnosus, Lactobacillus plantarum, Lactobacillus
      fermentum and Bifidobacterium longum at two different concentration. During the course of the
      study all the probiotic types were administered both singularly and in combination. From each
      subject urine and serum samples are collected before and during the supplementation and are
      analysed by nuclear magnetic resonance spectroscopy and statistical analyses.
    

Intervention name(s): probiotics
Intervention type(s): Dietary Supplement
Intervention description(s): In the first phase: 10 subjects have added in the diet a daily dose of 1 billion of freeze-dried LDD01 probiotics (A arm), 12 individuals are supplemented with a daily dose of 1 billion of the DLBL mix (B arm). In the second phase: 10 individuals are supplemented with a daily low dose of probiotics blend (C arm) and 10 individuals are supplemented with a daily high dose of probiotics blend (D arm).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Distribution of Nutrient Derived Amino Acids
Condition: Muscle Mass; Protein Intake; Diet Modification; Protein Synthesis; Protein Breakdown; Sarcopenia
MeSH terms: Sarcopenia
Study type: Interventional

Summary: 
      The project examines over several days how the distribution pattern of dietary protein
      stimulate and affect the protein turnover of important proteins in the aging perspective,
      such as skeletal muscle proteins.
    


Intervention name(s): Distribution pattern of dietary proteins (minced meat)
Intervention type(s): Other
Intervention description(s): Study effect of an even or skewed distribution pattern of dietary protein
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Dietary protein; Sarcopenia; Protein turnover; Muscle protein
Choosing Opioid Management for Pain and Analyzing Acute Chest Syndrome (ACS) Rates Equally
Condition: Pain; Sickle Cell Disease
MeSH terms: Anemia, Sickle Cell
Study type: Interventional
Phase: Phase 3

Summary: 
      The pathophysiology of sickle cell disease (SCD) manifestations, are complex with
      interactions of intracellular hemoglobin, membrane and endothelial activation but the
      hallmark remains recurrent and painful vaso-occlusive episodes (VOC). These painful episodes
      are thought to result from ischemia caused when small blood vessels are occluded by
      misshapen, inflexible erythrocytes. Painful episodes are the most common cause of
      hospitalization, morbidity, and impairment for SCD patients. There is no therapy that
      completely prevents or directly aborts painful events for all patients. Consequently,
      treatment for acute VOC is primarily supportive using hydration and medicinal pain control.
      Every pain medication has the potential to relieve pain but is associated with significant
      limitations and side effects.

      The primary hypothesis to be tested in this double blind, randomized controlled trial is that
      Nalbuphine is equivalent to morphine for pain control and patients will suffer fewer episodes
      of acute chest syndrome. The investigators also expect subjects will report fewer side
      effects from respiratory depression, abdominal distention from reduced peristalsis, reduced
      histamine release causing pruritis and still be provided adequate pain control. Further
      hypotheses to be tested is ability to recruit patient participants while being treated in the
      Emergency Department and that continuous infusion of Nalbuphine with accompanying patient
      controlled analgesia (PCA) is safe and effective in controlling pain, requiring less total
      opiates consumption, while decreasing length of hospitalization.
    


Intervention name(s): Morphine; Nubain
Intervention type(s): Drug; Drug
Intervention description(s): Loading Dose: 0.1mg/kg. May repeat every 15 min up to a maximum of 3 total doses until pain controlled.
Continuous rate: 0.01-0.04mg/kg/hr (titrated to comfort level) PCA dose 0.01-0.03 mg/kg maximum 1.6 mg/dose 4 hour dose limit 0.24-0.3 mg/kg (Maximum dosing will not exceed 25 mg/4 hrs).; Loading Dose: 0.1mg/kg. May repeat every 15 min up to a maximum of 3 total doses until pain controlled.
Continuous rate: 0.01-0.04mg/kg/hr (titrated to comfort level) PCA dose 0.01-0.03 mg/kg maximum 1.6 mg/dose 4 hour dose limit 0.24-0.3 mg/kg (Maximum dosing will not exceed 25 mg/4 hrs).
Intervention MeSH terms: Morphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: pain; sickle cell; nubain; morphine; acute chest; side effects
Implementing Physical Activity Guidelines for Adults With MS
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      The proposed project will evaluate two methods of implementation of the new Physical Activity
      Guidelines (PAGs) for Adults with Multiple Sclerosis (MS) living in two Ontario communities.
      The investigators will also determine if following the PAGs will improve aspects of fitness,
      function, quality of life and risk for cardiometabolic disease in this population. The
      investigators hypothesize that adherence to the PAGs will be higher in people who have been
      referred directly to a community-based exercise program, and that this greater adherence to
      physical activity will be associated with greater improvements in fitness, function and
      quality of life.

      This randomized controlled trial will provide important information on how best to implement
      physical activity recommendations within the community setting; this information will be
      translated to key stakeholders during the final stages of the project.
    


Intervention name(s): Direct Referral to physical activity
Intervention type(s): Other
Intervention description(s): Participants randomized to the Direct Referral to Physical Activity Arm will be provided with a referral to a physical activity program in their community and will be closely monitored in this program for 16 wks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: physical activity; exercise guidelines; multiple sclerosis
Nefazodone in the Treatment of Social Phobia
Condition: Social Anxiety Disorder (SAD)
MeSH terms: Anxiety Disorders; Phobia, Social
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine the effectiveness of nefazadone in patients with
      social anxiety disorder (SAD).
    

Detailed description: 
      The purpose of this study is to examine the efficacy of the 5HT2 receptor antagonist
      nefazadone in SAD, and to explore regional cerebral blood flow in patients with SAD when
      confronted with a personal phobic stimulus, using positron emission tomography (PET). Changes
      in cerebral blood flow were correlated with self-rated anxiety measures.
    

Intervention name(s): Nefazodone
Intervention type(s): Drug
Intervention MeSH terms: Nefazodone
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Social anxiety disorder; social phobia; positron emission tomography (PET; regional cerebral blood flow (rCBF); nefazodone; amygdala
ICG to Assess Ovarian Perfusion
Condition: Fibroid Uterus; Endometriosis; Uterus Myoma; Uterine Fibroid; Uterine Adenomyosis; Endometrial Cyst; Uterine Cyst
MeSH terms: Leiomyoma; Myofibroma; Cysts; Endometriosis; Adenomyosis
Study type: Interventional
Phase: Early Phase 1

Summary: 
      To assess the feasibility of using intravenous ICG to characterize the vascular perfusion of
      ovaries during gynecologic surgery
    

Detailed description: 
      The purpose of this study is to determine the feasibility of intravenous ICG administration
      to facilitate assessments of ovarian vascular perfusion. Historically, assessment of ovarian
      perfusion has been performed visually or via ultrasound with Doppler evaluation. In patients
      with ovarian endometriomas, evidence of ovarian interstitial microvascular injury has been
      demonstrated similarly by the presence of low flow and high RI. The use of ICG to evaluate
      ovarian perfusion specifically has not been reported. The use of ICG for intraoperative
      perfusion assessment of the ovary could provide more information about the health of the
      ovary and inform the surgical approach to ovarian pathology.

      ICG will be injected intravenously to assess ovarian perfusion in the presence or absence
      (control) of pathology. Near infrared fluorescence imaging will be used to illuminate the
      ICG. The extent of perfusion will be determined using digital imaging software.
    

Intervention name(s): ICG
Intervention type(s): Drug
Intervention description(s): Indocyanine green (ICG) is a Food and Drug (FDA)-approved tricarbocyanine dye that is fluorescent under near-infrared (NIR) light. ICG solutions for injection often contain sodium iodide. ICG is water soluble and when introduced intravenously, it is bound by plasma proteins, namely albumin. The intravascular half-life of ICG is 3-4 minutes with rapid hepatic clearance.
Other intervention name(s): Indocyanine green (ICG)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
The Efficacy of Phosphatidylserine-Omega3 in Elderly With Age Associated Memory Impairment
Condition: Age Associated Memory Impairment
MeSH terms: Memory Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective of this trial is to assess the ability of an oral administration of
      Phosphatidylserine-Omega3 to improve attention and memory complaints in comparison to placebo
      in age associated memory impaired subjects.
    


Intervention name(s): PS-Omega3; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Phosphatidylserine-Omega3 capsules 3x100mg/day 15 wk. Next, follow up phase, open label,1x100mg/day, 15 wk; Placebo cellulose tainted with fishy odor capsules 3x100mg/day 15 wk
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Menopur® Versus Follistim® in Polycystic Ovarian Syndrome (PCOS)
Condition: Polycystic Ovarian Syndrome; Infertility
MeSH terms: Polycystic Ovary Syndrome; Infertility; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      This multicenter, randomized, open-label exploratory study will be performed in approximately
      200 polycystic ovary syndrome (PCOS) but otherwise healthy females undergoing in vitro
      fertilization (IVF). Each study center will follow its standard practice for in vitro
      fertilization (IVF) within the study parameters as noted in this protocol. The study centers
      will use marketed products purchased from Schraft's Pharmacy for all phases of the study
      (down-regulation, stimulation, ovulation induction, and luteal support). Subjects will be
      randomly assigned to highly purified menotropin (Menopur®) or follitropin beta (Follistim
      Pen®) for stimulation and progesterone vaginal insert (Endometrin®) or progesterone in oil
      for luteal support. Subjects will return to the study center for regular scheduled clinic
      visits as required per in vitro fertilization (IVF) protocol at the site and at specified
      times during the cycle (Stimulation Day 6, Day of human chorionic gonadotropin (hCG), and
      first serum pregnancy test) for estradiol (E2), progesterone (P4) and human chorionic
      gonadotropin (hCG) labs. All subjects will be required to complete a final study visit at
      completion of luteal support or negative serum pregnancy test following embryo transfer.
    


Intervention name(s): Menotropin; Progesterone vaginal insert; Follitropin beta; Progesterone in oil; leuprolide acetate
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 225 IU (up to 450 IU) by subcutaneous injection once per day for up to about 15 days.; 100 mg inserted vaginally 2 or 3 times daily (BID or TID) (start on the day after oocyte retrieval) until 10 weeks gestation or confirmation of negative pregnancy test.; 225 IU (up to 450 IU) by subcutaneous injection once per day for up to about 15 days.; 50 mg by intramuscular injection once per day, starting on the day after oocyte retrieval until 10 weeks gestation or confirmation of negative pregnancy test.; Daily administration of 0.5mg of leuprolide acetate (depot formulations were not permitted) began on Day 21 following onset of menses, and then decreased to 0.25 mg when gonadotropin therapy was initiated.
Other intervention name(s): Menopur®; Endometrin®; Follistim Pen®; Lupron
Intervention MeSH terms: Leuprolide; Menotropins; Progesterone; Follicle Stimulating Hormone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pre-menopausal women; PCOS; polycystic ovarian syndrome; infertility; IVF; in vitro fertilization
PET-based Evaluation of Chemotherapy-induced Brain Damage in Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma; Brain Injuries
Study type: Interventional

Summary: 
      Positron emission tomography (PET) with 18-fluoro-deoxy-glucose (PET-FDG) is emerging as a
      promising approach for detecting brain lesions in dementia, among which Alzheimer's disease
      has been the most widely studied.
    

Detailed description: 
      Alteration of neuro-cognitive function induced by chemotherapy has been extensively
      documented in breast carcinoma patients. These modifications consist in the decrease of
      memory, intellectual capacity, speed analysis, and represent a real limitation for patients,
      sometimes durable. Aggressive lymphomas (diffuse large B cell lymphomas/DLBCL) represent a
      common disease, the standard being
      Rituximab-Cyclophosphamide-Doxorubicine-Vincristine-Prednisone (RCHOP) regiment which
      contains, as for breast cancer patients, anthracyclines. However, very little is known about
      the incidence and severity of cognitive function alteration in these patients. The occurrence
      of such complications should also be facilitated because of frail cognitive states due to age
      and co-morbidity. Cognitive function alteration is usually measured by neuropsychological
      tests (NPT) which are easy to handle and sensitive, but could lack specificity, in the
      context of general degradation which is often observed in hematological patients.

      Positron emission tomography with 18-fluoro-deoxy-glucose (PET-FDG) is emerging as a
      promising approach for detecting brain lesions in dementia, among which Alzheimer's disease
      has been the most widely studied. In our center, the investigators have already described
      glucidic hypometabolism in several brain territories associated with Alzheimer's disease and
      other dementia. Moreover, uptake quantification and topography are useful markers for
      determining the type of the disease and progression. PET-FDG received very little attention
      for the detection of chemotherapy-induced brain damages.
    

Intervention name(s): PET-FDG brain imaging and NPT
Intervention type(s): Device
Intervention description(s): PET-FDG brain imaging and NPT should be performed at T0, at Tf (within 1 month after chemotherapy termination), T+12. Several PET parameters should be calculated: minimal SUV (Standard Uptake Value), maximum SUV, and mean SUV for each of 20 cortical and sub-cortical territories.
Other intervention name(s): 18F-Fluoro-Desoxy-Glucose brain imaging and NPT
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Positron-Emission Tomography; chemotherapy-induced brain damage; neuro-cognitive function alteration
Clinical Trial of HIV Vaccine Combinations in Healthy Men and Women
Condition: Human Immunodeficiency Virus
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections; Immunologic Deficiency Syndromes
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomised two-part Phase I study which will explore the impact of different
      boosting options (MVA-CN54 and recombinant CN54gp140 protein) for oral Adenovirus serotype 4
      vector prime expressing HIV-1 CN54 envelope (Ad4-EnvCN54) designed to optimize systemic and
      mucosal antibody responses.

      Part 1 is exploratory and designed to select conditions capable of promoting enhanced
      systemic and mucosal B cell responses in a limited number of participants. Part 2 is
      dependent upon Part 1 and is designed to study groups selected on performance in part 1 in an
      expanded number of subjects. Data from both stages will be combined for safety and
      immunological analyses.
    


Intervention name(s): Ad4-EnvCN54; MVA-CN54; CN54gp140/MPLA
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Live, replication-competent adenovirus 4 vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54; Live, non-replicating modified vaccinia Ankara vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54; Recombinant glycoprotein of HIV-1 isolate 97CN54, with liposomal monophosphoryl lipid A adjuvant
Other intervention name(s): CN54-M
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Improvement of Fitness in Obese Children
Condition: Pediatric Obesity
MeSH terms: Obesity; Pediatric Obesity
Study type: Interventional

Summary: 
      This study observes fitness level and health parameters in children ages 6-12 years old with
      obesity using an exercise class intervention.
    

Detailed description: 
      The purpose of this study is to improve physical fitness and health parameters in
      elementary-aged children who participate in an academic weight loss clinic. Patients and
      their parents are randomly assigned to either take exercise classes or to continue standard
      care (control group). Exercise classes are run at a local church 3 times a week for 8 weeks
      and children and parents are expected to participate. Parents are expected to follow similar
      dietary and exercise recommendations which are given to their children. Vitals, lab work and
      fitness testing are done on children at beginning, middle and end of the 6- month study.
      Vitals are done on parents at the beginning, middle and end of the study. Children are given
      Fitbits to record sleep patterns and daily physical activity.
    

Intervention name(s): Exercise class; Home exercise
Intervention type(s): Other; Other
Intervention description(s): Same as above.; Same as above.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: exercise, fitness, sleep, children, obesity
A Study to Test How BI 1015550 is Taken up in the Blood of People With and Without Kidney Problems
Condition: Renal Insufficiency; Healthy
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is open to adults aged 18 years and older. People without kidney problems and
      people who have moderate or severe kidney problems can join the study.

      The purpose of this study is to find out how a medicine called BI 1015550 is taken up in the
      blood of people with and without kidney problems. Kidney problems may change how a medicine
      is taken up in the blood. All participants take a single tablet of BI 1015550.

      Participants are in the study for about 2 weeks. During this time, they visit the study site
      6 times. On the second visit, participants stay overnight at the study site for 4 nights. At
      the visits, doctors take blood samples to measure the levels of BI 1015550 in participants'
      blood. Then they compare the results between the groups of participants with and without
      kidney problems. The doctors also check participants' health and take note of any unwanted
      effects.
    


Intervention name(s): BI 1015550
Intervention type(s): Drug
Intervention description(s): BI 1015550
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment