bioihbjkbjnl/mcl2 huggingface dataset:
Pilot Study Comparing Two Versions of Group Cognitive-behavioral Indicated Prevention Programs
Condition: Depressive Symptoms
MeSH terms: Depression
Study type: Interventional

Summary: 
      The purpose of this study is to compare the effectiveness of two depression prevention
      programs and a control brochure for college students. Participants may experience reductions
      in depressive symptoms and prevention of future depression.
    


Intervention name(s): Group-based therapy
Intervention type(s): Behavioral
Intervention description(s): College students with depressive symptoms will be randomized to one of three conditions: 1) a cognitive behavioral prevention intervention, 2) a cognitive behavioral prevention intervention with counter-attitudinal elements or 3) an educational brochure control. We will test if the additional of counter attitudinal elements produces intervention effects when delivered to participants with sub threshold depressive symptoms.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Phase II Clinical Trial to Evaluate the Efficacy and Safety of the Treatment With BPL-1 in Adult Patients With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Diabetes Mellitus type 2 (T2DM) is a chronic and progressive disease, characterized mainly by
      hyperglycemia. Metabolic imbalance causes an increased risk of microvascular and
      macrovascular complications associated with the increased prevalence of cardiovascular
      disease (CVD) in diabetics.

      Although genetic predisposition determines individual susceptibility to T2DM, external
      factors such as an unhealthy diet and a sedentary lifestyle condition the onset of the
      disease.

      Since T2DM is a multifactorial disease, many authors have studied the possible role of the
      microbiota and its alterations in the pathophysiology of the disease. There is evidence that
      in T2DM there are alterations in the proportion of Firmicutes, Bacteroidetes and
      Proteobacteria, and a smaller amount of bifidobacteria with anti-inflammatory properties.

      Probiotics are living microorganisms present in food that, if consumed in sufficient
      quantities, can improve health. In general, probiotics protect the patient through
      immunomodulation, protecting him from infections, increasing the activation of mononuclear
      cells and lymphocytes.

      The investigational product is a supplement to the probiotic Bifidobacterium animalis subsp.
      lactis (BPL-1) CECT 8145. There are numerous studies carried out on different strains of
      GLP-1 that demonstrate its safety. Many of them are commonly used in the food industry, not
      only because of their proven safety, but also because of their viability until consumption.

      This clinical trial is proposed as an interdisciplinary study that can contribute to the
      characterization of the efficacy of treatment with probiotics in patients with T2DM of
      different stages of evolution, without and with hepatic involvement.
    


Intervention name(s): BPL-1 Probiotic capsules; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): BPL-1 Probiotic 1 capsule/day; Placebo masked with the same presentation as the experimental product 1 capsule/day
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Single-centre, randomized, double-blind clinical trial
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Diabetes Mellitus; Microbiote; Cardiovascular Risk
Assessment of the Biodistribution and Safety of [18F]MNI-958 in Healthy Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The overall goal of this protocol is to evaluate the biodistribution of [18F]MNI-958 also
      known as APN-0000455 or PM-PBB3, as a tau targeted radiopharmaceutical.
    

Detailed description: 
      The overall goal of this protocol is to evaluate the biodistribution of [18F]MNI-958 also
      known as APN-0000455 or PM-PBB3, as a tau targeted radiopharmaceutical. The specific
      objectives are:

        -  To determine the radiation dosimetry of [18F]MNI-958

        -  To assess the safety and tolerability of a single dose of [18F]MNI-958
    

Intervention name(s): [18F]MNI-958
Intervention type(s): Drug
Intervention description(s): Healthy Volunteers recruited for the study will undergo a single [18F]MNI-958 injection and PET scan.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: HV
A Trial to Assess the Functionality of Female Condom With a Silicone Elastomer Vaginal Ring
Condition: Human Immunodeficiency Virus
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      A multi-center, open-label, randomized, two-period, crossover non-inferiority trial to assess
      the functionality of female condoms with a silicone elastomer vaginal ring.
    

Detailed description: 
      This was an open-label, randomized, 2-period, crossover non-inferiority trial, conducted over
      4.5 months at two research centers in the USA among 81 healthy, monogamous, heterosexual,
      sexually active couples to assess the functionality of female lubricated, nitrile condoms
      during vaginal intercourse in the presence and absence of a silicone elastomer placebo
      vaginal ring.
    

Intervention name(s): Silicone Elastomer Vaginal Ring; Female Condom
Intervention type(s): Combination Product; Device
Intervention description(s): Silicone Elastomer Vaginal Ring; Female condom
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Transversus Abdominis Plane Block for Post-operative Analgesia Following Cesarean Section
Condition: Analgesia
MeSH terms: Agnosia
Study type: Interventional

Summary: 
      Postpartum analgesia is a common concern after Cesarean Section (CS). The quality of
      postoperative recovery is improved by opioid sparing pain control approaches. The transversus
      abdominis plane block (TAPB) is an effective technique for postpartum analgesia after
      cesarean section. Pregnancy results in thinning of the internal oblique aponeurosis; with
      increased incidence of missing the second pop to reach the transversus abdominis plane (TAP).
      The classic blind approach to the TAP is associated with several complications; so, it has
      been largely replaced by the ultrasound-guided approach to the TAP. The ultrasound-guided
      approach to the TAPB was first described by Hebbart and his colleagues in
      2007.Ultrasound-guided TAPB improves the success of the block, reduces the volume of local
      anesthetic used and prevents the potential injury of adjacent structures.

      Surgical approach to the TAPB was also described, it is a quick and easy approach of
      establishing a reliable block. The surgeon performs an intra-abdominal approach to the TAPB;
      by which asepsis is easily attained, visible and tactile confirmation of correct needle
      placement may be achieved with no risk of damage to the viscera but care must be given to
      avoid injury of the inferior epigastric vessels.
    

Detailed description: 
      Compare the Transversus Abdominis Plane Block via the modified surgeon assisted approach
      (Study group), to the ultra-sound guided approach (Control group); as regards the
      post-operative analgesia following Cesarean Section.
    

Intervention name(s): TAPB
Intervention type(s): Procedure
Intervention description(s): TAPB will be given to parturients whether by the modified surgeon assisted approach or by the ultra-sound guided approach.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: post-operative analgesia; Transversus Abdominis Plane Block
Effects of Octreotide Acetate on Circulating Levels of Chromogranin A in Advanced Prostate Cancer Patients
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The present study will provide information on whether the somatostatin analog, octreotide
      acetate, could have an inhibitory effect on circulating chromogranin A. The demonstration of
      an antisecretory effect of somatostatin analogs could offer a rationale for a large scale
      randomized study.
    


Intervention name(s): Octreotide LAR
Intervention type(s): Drug
Intervention MeSH terms: Octreotide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HRPC; octreotide LAR; CgA
A Guideline Approach to Therapy Step-down Utilising Flutiform Change and Step-down
Condition: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study is to compare two licensed asthma inhalers and to then evaluate the
      safety of reducing treatment when patient's asthma is in control. The inhalers used in this
      study are the Seretide® 250 Evohaler®, which is widely used in UK, and a recently licensed
      inhaler called Flutiform®. National guidelines recommend that asthma medication should be
      increased when patients are experiencing worsening of their asthma, and reduced when asthma
      is in control. However, it is likely that in daily clinical practice some patients are
      over-treated. It is therefore necessary to conduct more studies which demonstrate that
      reducing treatment dosage can be done safely.

      This study has two phases. In the first phase the investigators aim to recruit 224 patients
      through approximately 40 clinics in the UK and Ireland. One third of these patients will be
      selected in random to use the high dosage Seretide® 250 Evohaler® and two thirds will use
      high dose Flutiform® 250 inhaler for 12 weeks. At the end of phase 1 the investigators will
      compare how well asthma was controlled between the two groups.

      After phase 1 those patients who used Flutiform and did not have any problems with their
      asthma can participate in phase 2. In phase 2 half of the patients will stay on high dosage
      Flutiform 250 and half will be switched to the medium dosage Flutiform 125 inhaler. At the
      end of phase 2 the investigators will compare asthma control between the two groups.

      This study will be conducted by Research in Real Life Ltd (Cambridge, UK) with partial
      funding from Napp Pharmaceuticals Ltd. The estimated total duration of the study is 18 months
      and each patient will spend a maximum of 6 months in the study.
    


Intervention name(s): Fluticasone 250/formoterol 10; Fluticasone 250/salmeterol 25; Fluticasone 125/formoterol 5
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): Flutiform 250; Seretide 250 Evohaler; Flutiform 125
Intervention MeSH terms: Fluticasone; Xhance; Formoterol Fumarate; Salmeterol Xinafoate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy and Safety Study of Fluticasone Proponate Inhalation Solution in Adult and Adolescent Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multicentre, randomized, single-blind, active-controlled, parallel-group phase III
      local registration study for a treatment period of 12 weeks. This study aims to assess the
      effectiveness and safety of fluticasone propionate 1mg via nebulizer BID in treatment of
      Chinese adult and adolescent patients with severe persistent asthma for a treatment period of
      12 weeks versus budesonide 2mg via nebulizer BID. The steady-state plasma pharmacokinetics of
      fluticasone propionate inhalation solution will also be assessed.
    

Detailed description: 
      Male or female subjects between 17 to 70 (inclusive) years of age with severe persistent
      asthma meeting the inclusion criteria and having completed the screening period of 2 weeks
      will, in a proportion of 1:1, randomly receive fluticasone propionate 1mg via nebulizer BID
      or budesonide 2mg via nebulizer BID for a treatment period of 12 weeks. The clinic visit will
      be arranged at 2 weeks, 4 weeks, 8 weeks and 12 weeks during study treatment. If the subjects
      meet the criteria of pre-defined asthma control at treatment 4 weeks or 8 weeks, they will
      have one chance to be treated with the half dose of study drug. 2 weeks after completion of
      study treatment or after early withdrawal from study, the follow-up visit will be performed
      to assess the post-treatment adverse events. The primary endpoint is the mean change from
      baseline in morning peak expiratory flow (PEF) over the 12 week treatment period. Safety
      assessments include adverse events, vital signs, oral and oropharyngeal candidiasis,
      hematological, biochemical tests), 24-hour urinary cortisol and 12-lead ECG. The steady-state
      plasma pharmacokinetics of fluticasone propionate inhalation solution will also be assessed.
    

Intervention name(s): fluticasone propionate inhalation solution; budesonide suspension
Intervention type(s): Drug; Drug
Intervention description(s): 1 mg BID inhalation for 12 weeks with one possible chance to change to 0.5 mg BID; 2 mg BID inhalation for 12 weeks with one possible chance to change to 1 mg BID
Intervention MeSH terms: Fluticasone; Xhance; Budesonide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: fluticasone propionate inhalation solution; budesonide suspension for inhalation; efficacy; severe persistent asthma; pharmacokinetics; safety
Pilot Study of Safety and Toxicity of Acquiring Hyperpolarized Carbon-13 Imaging in Children With Brain Tumors
Condition: Pediatric Brain Tumors
MeSH terms: Brain Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single arm pilot trial within the Pacific Pediatric Neuro-Oncology Consortium
      (PNOC).

      The pilot study will look at the safety and toxicity of acquiring hyperpolarized carbon-13
      imaging in children with brain tumors.
    

Detailed description: 
      This is an open label trial to assess the safety and tolerability of the adult tolerated dose
      of Hyperpolarized Pyruvate (HP) for metabolic imaging in children with brain tumors who do
      not require sedation for their MR imaging. Nine patients will receive a single MR imaging
      examination that includes the acquisition of hyperpolarized 13C metabolic data in combination
      with anatomic, diffusion, perfusion and lactate edited 1H spectroscopic imaging data. The
      data will be processed using custom designed software to estimate changes in levels of
      lactate/pyruvate and to relate them to abnormalities observed in the data from other MR
      modalities.

      The results of this study will provide the safety data required to move this type of
      metabolic imaging into therapeutic trials to assess the utility of HP 13C lactate/pyruvate as
      a new surrogate marker of drug tumor penetration and early response to therapy in children
      with brain tumors.
    

Intervention name(s): Hyperpolarized Pyruvate
Intervention type(s): Drug
Intervention description(s): Hyperpolarized Pyruvate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: brain tumor; children
Longitudinal (Weekly) Follow-up of Active Plaques in Multiple Sclerosis With 3 Teslas Multi-modality MRI Using Diffusion, Perfusion, Venography and Proton Spectroscopy
Condition: Lesions; Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      It is difficult to determinate prognostic criteria of Multiple Sclerosis with conventional
      MRI insofar as physiopathology is not well-known: the precise sequences of events leading to
      plaque formation and axonal injury are still not completely understood.

      Some elements involved in plaque formation can be studied thanks to MR techniques
      (cerebrospinal fluid and periveinular spaces, neuronal injury, microglia, and cerebral
      microcirculation's dysfunction).

      This study aims at giving a better understanding of MS plaques' physiopathology, using data
      from modern MRI through a longitudinal followed up with weakly MR 3T examination.
    

Detailed description: 
      The objective of this work are:

        -  study weakly development of the active MS plaque with multimodal MRI parameters using
           advanced MRI techniques: Veinography/3D FLAIR, Diffusion (CDA), Perfusion (CBV, CBF,
           MTT) MR Spectroscopy (NAA, myo-inositol, choline, lactate…) and enhanced 3DT1 sequences.

        -  define prognostic markers of MS aggressiveness ("black holes")

        -  Study development of MS plaque around venous structures.
    

Intervention name(s): 3T MR scanner
Intervention type(s): Procedure
Intervention description(s): The follow-up will be scheduled for one year; it will consist in a weekly MR examination during the first two months, and subsequently on the 6th and the 12th months.
We will perform for each MRI exploration an intravenous injection of contrast agents: gadobutrol (gadovist 1,0 mmol/ml) which is a stable agent with a cyclic structure. This agent is few responsible for NFS, given their low capacity to liberate gadolinium GD3+ in tissues.
The same imaging protocol will be performed for each MR examination. Evaluation of creatinemia will be used before inclusion and during the 1st, 3rd, 5th, 7th, 9th, and the 10th MRI examination. Thus we will take advantage of catheter to perform the creatinemia blood test and to reduce the discomfort produced by the injection.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Multiple sclerosis; Active plaque; Multimodal analysis; 3T MRI; Weekly follow-up; Physiopathology; Physiopathology of active lesions formation in Multiple Sclerosis using multimodal MR sequences
Bowel Dysfunction After Rectal Cancer Treatment
Condition: Low Anterior Resection Syndrome
MeSH terms: Intestinal Diseases; Low Anterior Resection Syndrome
Study type: Observational [Patient Registry]

Summary: 
      Bowel dysfunction after rectal cancer treatment may significantly affect the quality of life.
      Our study aimed to estimate the incidence and characterize the Low Anterior Resection
      Syndrome(LARS). We performed a prospective evaluation of patients treated with anterior
      resection for rectal cancer at two hospitals. Assessment was performed at baseline, after
      neoadjuvant treatment, and 1, 6 and 12 months after bowel transit reconstruction using the
      following scores: Bristol scale, LARS score, MSK-BFI, FIQL, EORTC-QLQ30 and a visual analogue
      scale.
    

Detailed description: 
      Low anterior resection syndrome (LARS) refers to wide-ranging symptoms including evacuatory
      dysfunction, fecal urgency and incontinence. The assessment of bowel dysfunction after rectal
      cancer treatment has improved since the development of the LARS score. This score has widely
      been used with a meta-analysis reporting a pooled prevalence of "major LARS" of 41%. However,
      several studies have found a large proportion of patients with major LARS in the general
      population without rectal cancer raising questions about the specificity of this score.
      Moreover, most studies on the prevalence of LARS do not include a baseline evaluation and,
      therefore, may not allow establishing whether the dysfunctions appeared after the treatment.
      Consequently, we considered that a prospective study including a baseline evaluation and
      multiple validated questionnaires was required. The present study aimed to estimate the
      incidence and characterize bowel dysfunction after rectal cancer treatment. The results of
      this study will be useful to improve the preoperative information given to the patient and
      the shared decision-making process.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with anterior resection for rectal adenocarcinoma with curative intention, with or
        without neoadjuvant chemoradiotherapy
Protein Digestibility of Whey and Zein.
Condition: Biological Availability
Study type: Interventional

Summary: 
      The evaluation of protein quality has top priority according to Food and Agricultural
      Organization of the United Nations. However, one aspect of protein quality, namely the
      digestibility of protein is largely unknown. A database on this matter is lacking as it is
      difficult to measure ileal digestibility in humans.
    

Detailed description: 
      Objective: This study aims to determine the digestibility of amino acids in two protein
      sources in men and women with normally functioning ileostomies.

      Study design: Intervention study with 6 test days, testing 3 meals each twice. Study
      population: Eight men and women with normally functioning ileostomies will be recruited for
      the study.

      Intervention: On six separate test days, subjects will receive a meal, consisting of a drink
      and biscuit. With this, two different protein containing meals, i.e. zein and whey, and a
      protein-free meal is tested; these three treatments are given at two occasions, thus in total
      6 meals are tested. After consumption of the meal, subjects collect their digesta for nine
      hours.

      Main study parameters/endpoints: Ileal amino acid digestibility of zein and whey protein
      isolate.

      Nature and extent of the burden and risks associated with participation, benefit and group
      relatedness: The subject will not benefit from the study except for the contribution to
      scientific research. The risk of participating to this study is low, some gastrointestinal
      discomfort could occur. Subjects have to come to the research facility seven times, a
      screening visit of 1 hour, and 6 experimental days of 10 hours. Subjects will be financially
      compensated for participation.
    

Intervention name(s): whey protein isolate; Zein; protein-free
Intervention type(s): Dietary Supplement; Dietary Supplement; Other
Intervention description(s): whey protein isolate; zein protein; protein free
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Intervention study with 6 test days, testing 3 meals each twice
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Digestibility; Whey; Zein; Protein; Ileostomates
Phase 2 Study of NGM282 in Patients With Primary Biliary Cirrhosis
Condition: Primary Biliary Cirrhosis
MeSH terms: Liver Cirrhosis; Liver Cirrhosis, Biliary; Fibrosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the safety, tolerability, and activity of NGM282 in
      patients with Primary Biliary Cirrhosis.
    


Intervention name(s): NGM282; Placebo
Intervention type(s): Biological; Biological
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment