bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Evaluate the Safety, Immunogenicity and Efficacy of GlaxoSmithKline (GSK) Biologicals' Candidate Malaria Vaccine RTS,S/AS02A, When Administered to Children Aged 1 to 4 Years Living in a Malaria-endemic Region of Mozambique.
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 2

Summary: 
      Malaria is an important cause of death and serious illness among Mozambican children.
      Although the risk of malaria can be reduced by drugs and by impregnated bed nets, it would be
      helpful if children could be protected against malaria by a vaccine.

      GSK Biologicals is developing in partnership with Malaria Vaccine Initiative at PATH a
      candidate malaria vaccine RTS,S/AS02 for the routine immunization of infants and children
      living in malaria endemic areas. The vaccine would offer protection against malaria disease
      due to the parasite Plasmodium falciparum and also would provide protection against infection
      with hepatitis B virus. Previous studies have shown the candidate malaria vaccine RTS,S/AS02
      to be safe when administered in adults and children aged 1-11 years. However, to assess if
      this vaccine could provide protection against malaria in children, this study has been
      undertaken.
    

Detailed description: 
      In this study, the participating children will either receive either 3 doses of the new
      malaria vaccine or the control vaccine which has been selected because of its benefit to the
      children in preventing important childhood diseases. The control vaccines include the
      following:

        -  If the child is of 24 months or older, he/she may receive 3 doses of a vaccine, called
           Engerix-B™, which protects against hepatitis B.

        -  If the child is less than 24 months, he/she may receive: two doses of a vaccine called
           Prevnar® and one dose of a vaccine called Hiberix™. Prevnar® prevents pneumonia and
           meningitis caused by some Streptococcus pneumoniae bacteria. Hiberix™ prevents severe
           infections such as pneumonia and meningitis caused by Haemophilus influenzae type b
           bacteria (Hib). All children will be monitored for the development of malaria disease
           over an 18-month period extending from the third vaccination. All participants will also
           be monitored for vaccine safety from first vaccination to study close.
    

Intervention name(s): RTS,S/AS02A
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Bioequivalency Study of Anastrozole 1 mg Under Fed Conditions
Condition: Breast Cancer
MeSH terms: Malnutrition
Study type: Interventional

Summary: 
      The objective of this study was to prove the bioequivalence of Anastrozole Tablet under fed
      conditions
    


Intervention name(s): Anastrozole
Intervention type(s): Drug
Intervention description(s): 1 mg tablet
Other intervention name(s): ARIMIDEX
Intervention MeSH terms: Anastrozole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
HylaCare in the Treatment of Acute Skin Changes in Patients Undergoing Radiotherapy for Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      This will be a randomized, double blind, vehicle-controlled evaluation of the effectiveness
      and safety of HylaCareTM. The study will employ the patient as her own control, a commonly
      used method for the evaluation of topical dermatologic agents. Each patient will be
      randomized blindly as to whether the study serum will be applied to the medial or lateral
      portion of the treated breast, using the nipple as the dividing line. The product and placebo
      will also be applied to the contra-lateral breast in the same fashion, as a further control.
      The study drug and placebo will be applied three (3) times daily.
    

Detailed description: 
      Patients will be allocated to the treatment using a randomized permuted block. There will be
      no stratification. Patients will be randomized to receive the investigational product to be
      applied to either the medial (inside) or lateral (outside) portion of the breast, a placebo
      product will be used on the other side. Patients and clinical investigators will be blinded
      to the treatment assignments.
    

Intervention name(s): HylaCare; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): cream; placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Supportive Care
Keywords: external beam radiotherapy; breast cancer
Anti-stress Effect of Theanine on Students During Long-term Pharmacy Practices
Condition: Healthy Students
Study type: Interventional

Summary: 
      Long-term practices in a hospital setting and community pharmacy might induce chronic stress
      in students. Alterations of salivary amylase activity will be measured in students during
      pharmacy practices as a marker of stress. Theanine is reported to have anti-stress effect on
      experimental animals under chronic stress and on humans under short-term stress. The purpose
      of this study is to measure stress symptoms in students during long-term pharmacy practices
      and to evaluate the efficacy of theanine in suppressing chronic stress, by measuring the
      salivary amylase activity.
    

Detailed description: 
      The investigators have found that theanine, an amino acid in green tea, has anti-stress and
      anti-aging effects using experimental animals. Mice, under chronic psychosocial stress,
      showed shortened longevity and brain dysfunction. However, when the mice ingested theanine,
      they showed normal longevity and brain function even though the mice were under psychosocial
      stress. These data showed that theanine has a significant anti-stress effect on mice. In
      addition, theanine has been reported to have an anti-stress effect on humans against
      short-term stress by measuring salivary amylase activity. However, the efficacy of theanine
      against chronic stress has not been examined. Long-term pharmacy practices might induce
      chronic stress in students. Based on this background, the investigators designed a randomized
      study to evaluate the clinical efficacy of theanine ingestion in suppressing chronic stress
      in students during long-term pharmacy practices.
    

Intervention name(s): Theanine
Intervention type(s): Dietary Supplement
Intervention description(s): Taking 4 tablets of theanine two times daily for 16 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: stress; students; pharmacy practice; theanine; pharmacy training
Brain Imaging to Understand the Role of Inflammation in N-Acetyl Cysteine (NAC) Treatment of Bipolar Depression
Condition: Bipolar Disorder; Depression
MeSH terms: Depression; Depressive Disorder; Bipolar Disorder
Study type: Interventional
Phase: Early Phase 1

Summary: 
      We are trying to understand what causes bipolar disorder and how medications treat bipolar
      depression. Particularly, we are looking at the importance of inflammation in the process. If
      you participate, you will have two different brain scans (MRI and PET scan). You will also
      have an experimental treatment for your depression named N-acetyl cysteine (NAC). The study
      is funded by the Columbia University Irving Institute to improve the treatment of bipolar
      disorder. Please contact us if you are interested in participating. Up to $600 in
      compensation if you are eligible and choose to participate. Up to 6 months of treatment for
      depression at no cost to you.
    


Intervention name(s): N-acetyl cysteine (NAC)
Intervention type(s): Drug
Intervention description(s): Experimental medication with N-acetyl cysteine (NAC) for six weeks
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Inflammation; NAC; N-acetyl cysteine
RCE With FMT in the Treatment of Childhood Constipation
Condition: Fecal Microbiota Transplantation; Constipation - Functional
MeSH terms: Constipation
Study type: Interventional

Summary: 
      Constipation is the most common complaint in childhood gastrointestinal disease, affecting an
      estimated 20% of the global children.The treatment strategies consist of diet control,
      behavioral intervention and oral and sometimes rectal laxatives. Given higher success rate
      and fewer side effects, the laxative PEG3350 has been considered the first choice in
      childhood constipation.However, effectiveness of PEG 3350 laxative is not lasting, and the
      use of PEG increases the risk of fecal incontinence. Additional treatment interventions are
      still necessary.Enema can act directly on the rectum and distal colon to quickly relieve
      symptoms of fecal impaction which is considered one of main source of intractable
      constipation. Children with fecal impaction who received enema had fewer fecal incontinence
      and diarrhea than children who received PEG. There have been lots of evidence that enema is
      effective in fecal impaction in children with functional constipation.But there are still
      cases of recurrences noted after enema. Fecal bacteria transplantation (FMT) is a new
      treatment method emerging in recent years, which is widely used in the treatment of
      functional gastrointestinal diseases. FMT has been proved to play a very prominent role in
      correcting intestinal flora disorders. By transplanting exogenous flora into the intestinal
      tract of patients, FMT can inhibit bacterial reproduction, regulate intestinal environment
      and cascade the body immunity, so as to achieve the therapeutic effect of disease.

      Retrograde colonic enema with FMT, an new method, provides the possibility for the treatment
      of childhood constipation. However, there is still a lack of evidence-based support for the
      treatment of childhood constipation by retrograde colonic enema with FMT. Therefore, we
      designed a randomized, controlled, double-blind clinical trial to confirm the efficacy and
      safety of retrograde colonic enema with FMT in the treatment of childhood constipation.
    


Intervention name(s): Fecal supernatant; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Fecal supernatant from a child registered in the specimen bank that matches the subject's age, gender, and weight .; a placebo designed to match the FMT+RCE group based on appearance including 0.9% physiological saline.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Positron Emission Tomography-computed Tomography (PET-CT) for Main & Branch Intraductal Papillary Mucinous Neoplasm
Condition: Intraductal Papillary Mucinous Neoplasm
MeSH terms: Neoplasms; Neoplasms, Cystic, Mucinous, and Serous
Study type: Observational

Summary: 
      The purpose of the study is to prove the hypothesis that pancreas PET-CT can differentiate
      duct involved IPMN with malignancy from duct involved non-malignant IPMN.
    

Detailed description: 
      Duct involved intraductal papillary mucinous neoplasm is associated with a 35-70%
      (particularly involving the main duct) incidence of malignancy. Current guidelines recommend
      pancreatic resection for fit patients with main or branch duct involved IPMN. Pancreatic
      resection can be associated with morbidity and mortality. Reliable tests or biomarkers
      accurately differentiating non-malignant from malignant duct involved IPMN are non-existent.
      Test or biomarkers differentiating duct involved from duct uninvolved IPMN are also
      inaccurate. Patients with suspected duct IPMN with symptoms have a higher chance of
      associated malignancy. These findings are not specific for malignant IPMN so, if relied on,
      they would results in missed malignancies as well as potentially unnecessary operations in a
      significant percentage of patients. PET scanning has been studied retrospectively and
      purported to be a highly reliable indicator og high grade dysplasia and/or invasive cancer in
      patients with IPMN. Thus, PET could represent a future standard of care by some authorities
      in the work-up of patients with IPMN. This proposal seeks to prove the hypothesis that
      pancreas PET-CT can differentiate duct involved IPMN with malignancy from duct involved IPMN
      without malignancy.
    

Intervention name(s): PET-CT
Intervention type(s): Procedure
Intervention description(s): Pancreas Protocol PET-CT
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects are selected from group of patients in whom IPMN is suspected as they are seen in
        the clinic for consultation with the surgeon regarding their surgical procedure.
      
Keywords: IPMN
Effect of Maternal Obesity on Labour Induction in Postdate Pregnancy
Condition: Obesity; Induced; Birth
MeSH terms: Obesity, Maternal; Obesity
Study type: Observational

Summary: 
      This study investigate the progression of labour in 144 normal weight pregnant women (BMI
      <30) and 144 obese pregnant women (BMI >30) , not in labor admitted for induction of labor.
      These women are to be investigated for success of induction of labor.
    

Detailed description: 
      -  This prospective study will be conducted for 144 obese and 144 non obese ), post date
           (>41 wks), not in labor.

        -  Woman is classified as obese if BMI >=30.

        -  Prolonged pregnancy was defined as delivery on or after (41+0 weeks) of gestation.

        -  First informed consent will be obtained.

        -  Determination of gestational age

        -  Proper history taking, general and abdominal examinations will be done then digital
           examination will be performed to determine bishop score.

        -  And obstetric U/S scan will be done and by which the following data will be obtained :

             -  Fetal biometry

             -  Fetal heart activity

             -  Presentation

             -  Localization of the placenta.

             -  Amount of amniotic fluid.

             -  Exclude multifetal pregnancy.

        -  Induction of labor will be done using vaginal misoprostol according to the estimated
           Bishop score.
    

Intervention name(s): Misoprostol
Intervention type(s): Drug
Intervention description(s): Misoprostol 25 micrograms every 6 hours will be given to obese and non obese groups
Intervention MeSH terms: Misoprostol
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        144 pregnant women with BMI >= 30 and 144 pregnant women with BMI <30, post date >= 41 wks,
        not in labor admitted in Kaselaini H for induction of labor.
To Evaluate the Safety, Tolerability and Analgesic Efficacy of SAF312 in Postoperative Dental Pain Patients
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 2

Summary: 
      The study will assess the analgesic efficacy and safety and tolerability of a single oral
      dose of SAF312 in postoperative dental pain patients after 3rd molar extraction.
    


Intervention name(s): SAF312A; Placebo; Ibuprofen
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Ibuprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Postoperative pain
Identification of a Predictive Metabolic Signature of Response to Immune Checkpoint Inhibitors in Non-Small Cell Lung Carcinoma
Condition: Non Small Cell Lung Cancer
MeSH terms: Carcinoma, Non-Small-Cell Lung; Lung Neoplasms
Study type: Observational

Summary: 
      Immune checkpoints inhibitors (ICI) are becoming new standards of care for Non-Small Cell
      Lung Carcinoma (NSCLC) treatment. To date, no powerful predictive biomarker of response has
      been found.

      The investigators hypothesize that metabolomics profile could represent a potent biomarker of
      response to ICI
    

Detailed description: 
      Immune checkpoints inhibitors (ICI) are becoming new standards of care for Non-Small Cell
      Lung Carcinoma (NSCLC) treatment, both as first and second line of treatment. To date, no
      powerful predictive biomarker of response has been found. It has been recently shown that
      microbiota composition could dictate the ability of patients to respond to ICI. Since, the
      microbiota produces circulating metabolites that will subsequently act on immune system, the
      investigators hypothesized that metabolic signature, reflecting microbiota function, could
      represent a predictive biomarker of response to ICI.

      Primary objective is to identify baseline metabolic signature (metabolomics analysis by Mass
      spectrometry) associated to ICI response. Secondary objectives are to link metabolic
      signature with microbiota composition (metagenomics analysis RNA 16S) and immune profile, and
      altogether with clinic response to ICI. Profile evolution (metabolic, metagenomics and
      immune) will be also analyzed at 2-month post ICI initiation and at tumor progression, if
      any.

      In order to do so, the investigators thus plan to enroll 60 NSCLC patients treated by ICI as
      1st, 2nd or 3rd line of treatment in CHUGA in 18 months. Blood as well feces will be
      collected prior to, and at 2 month following ICI treatment initiation as well as at
      progression. Will be excluded from this study, patients that have received antibiotic or
      corticotherapy 2 or 4 weeks before ICI initiation, respectively.
    

Intervention name(s): Immune signature in serum associated to the metabolic signature; Meta-genomic signature of intestinal flora
Intervention type(s): Other; Genetic
Intervention description(s): Immune signature in serum associated to the metabolic signature; Meta-genomic signature of intestinal flora
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study cohort will include NSCLC patients treated by ICI as 1st, 2nd or 3rd line of
        treatment in Grenoble University Hospital (France) in 18 months. 60 NSCLC patients are
        anticipated to be enrolled in the study.
      
Biospecimen description: 
      Meta-genomic signature of intestinal flora
    
Keywords: Metabolomic; Microbiota
Evaluation of a Diabetes Vaccine in Newly Diagnosed Diabetics
Condition: Insulin-dependent Diabetes Mellitus; Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      Insulin dependent diabetes mellitus (also called type 1 diabetes mellitus or T1DM) is caused
      by the destruction of insulin-producing cells in the pancreas. People with T1DM do not
      produce enough insulin, which is necessary for proper regulation of blood sugar levels.

      T1DM is an autoimmune disease. An autoimmune disease is a disease in which the body's immune
      system attacks the body itself. In addition to regulating blood sugar, insulin may have the
      ability to protect cells in the pancreas from attack by the immune system. This study will
      evaluate whether an insulin-based vaccine can protect cells from autoimmune destruction.

      Study hypothesis: IFA-enhanced human insulin B-chain vaccination will lead to the arrest or
      slowing of the ongoing autoimmunity, and this will result in an appreciable difference in
      functioning B cell mass compared to the placebo treated group by the end of the study.
    

Detailed description: 
      The vaccine in this study, IBC-VSO1, is a synthetic, metabolically inactive form of insulin
      designed to prevent pancreatic beta-cell destruction. It does not cause fluctuations in blood
      sugar. This study will evaluate whether the vaccine protects against autoimmune attack at the
      onset of T1DM, before pancreas function has deteriorated. This experimental treatment must
      occur early because 60% to 85% of beta-cells are already destroyed by the time of T1DM
      diagnosis. If beta-cell destruction can be halted, a prolonged remission period after
      diagnosis may occur, with a subsequent delay in diabetes-related complications.

      Participants must have been diagnosed with T1DM for no more than 3 months at the time of
      enrollment in this study. Participants will be randomly assigned to either a vaccine group or
      a control group. Participants in the vaccine group will receive one injection of IBC-VS01;
      participants in the control group will receive a placebo. Participants will then be monitored
      for 2 years. Participants will have ten follow-up visits, which will include blood tests for
      immunological and genetic analysis. Throughout the study, metabolic tests will also be
      performed to measure the remaining capacity of self insulin production of the body.
    

Intervention name(s): IBC-VS01; IBC-VS01 placebo
Intervention type(s): Biological; Biological
Intervention description(s): IBC-VS01; IBC-VS01 placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Juvenile diabetes; Diabetes; Insulin; Vaccine; Type 1 Diabetes; Diabetes Mellitus
Bioequivalence Study of Cetirizine Hydrochloride 10mg Tablets Under Fasting Conditions
Condition: Healthy
MeSH terms: Disease
Study type: Interventional

Summary: 
      An open label, randomized, single-center, single-dose, two-treatment, two-period, crossover
      bioavailability study comparing Cetirizine Hydrochloride 10 mg tablet of Ohm Laboratories
      Inc. (A subsidiary of Ranbaxy, Inc) with Zyrtec® Cetirizine Hydrochloride, 10 mg tablet of
      Pfizer Labs (Division of Pfizer Inc.) in healthy, adult, human subjects under fasting
      condition
    

Detailed description: 
      The study was conducted as an open label, randomized, single-center, single-dose,
      two-treatment, two-period, crossover bioavailability of the test formulation of cetirizine
      hydrochloride tablet of Ohm Laboratories Inc. (A subsidiary of Ranbaxy, Inc) containing
      containing 10 mg cetirizine hydrochloride study comparing to the marketed product, Zyrtec®,
      containing 10 mg of cetirizine hydrochloride of Pfizer Labs (Division of Pfizer Inc.), in
      healthy, adult, human, subjects under fasting condition.

      Safety measures were performed throughout the study and included a physical examination,
      laboratory evaluation, and measurement of vital signs.

      A total of 32 subjects were randomized to receive single oral dose of cetirizine
      hydrochloride 10 mg tablet and 31 subjects completed both the periods of the study.
    

Intervention name(s): Cetirizine Hydrochloride 10 mg tablet
Intervention type(s): Drug
Intervention description(s): Bioequivalence Cetirizine Hydrochloride 10 mg tablet
Intervention MeSH terms: Cetirizine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Cetirizine Hydrochloride 10 mg tablet fasting conditions