bioihbjkbjnl/mcl2 huggingface dataset:
Probiotics and Low Protein Diet in Advanced Chronic Kidney Disease
Condition: Renal Failure Chronic
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Kidney Failure, Chronic
Study type: Interventional

Summary: 
      Here the investigators will perform a double-blinded randomized placebo-controlled clinical
      trial to evaluate the synergic effect of low protein diet and prebiotics in reducing the
      microbial inflammatory uremic toxins.
    

Detailed description: 
      ProLowCKD is a single-centre, double-blind, placebo-controlled, randomised study. At
      enrolment (T0) participants were prescribed a LPD in addition to their ongoing
      pharmacological therapy and according to their comorbidities; after 2 months (T2) they were
      randomized in accordance to a 1:1 ratio to receive probiotics or placebo for other 3 months
      (T5) in addition to the continuation of LPD. Enrolled subjects are invited to assume two
      doses of probiotic/placebo for 1 month and 1 dose for 2 months.

      Randomization is 1:1 to receive odd- or even envelopes, according to the odd- or even
      registration number at enrolment.

      Neither the clinician nor the patient knows the content of the odd- and even envelopes.

      The evaluations will be performed according to the following schedule: at T0 nephrological
      evaluation and biochemical analysis, dietary counselling, illustration of protocol and
      signing of the informed consent, administration of the SF36 questionnaire, body composition
      evaluation by bioimpedentiometry. At T0, T2, T5: blood biochemical parameters: haemoglobin,
      urea, creatinine, mean urea and creatinine clearance, CKD and MDRD calculation, sodium,
      potassium, uric acid, calcium, phosphate, PTH, acid-base balance, CRP, albumin, PC, IS,
      Lp-PLA2, LPS; 24h-urine biochemical parameters: urea, creatinine, sodium, proteins; microbial
      stools analysis; clinical nephrological and dietitian evaluation.
    

Intervention name(s): Probiotics
Intervention type(s): Dietary Supplement
Intervention description(s): Active composition: 5x109 of Bifidobacterium longum (mix DLBL), 1x 109 Lactobacillus reuteri LRE02 (DSM 23878) and maltodextrin (total 2 grams). The probiotic species employed were granted the Qualified Presumption of Safety (QPS) status by the European Food Safety Authority (EFSA) in 2007. Two envelopes per day and one envelope per day will be recommended for one and two months, respectively.
Placebo composition: maltodextrin (2 grams). Two envelopes per day and one envelope per day will be recommended for one and two months, respectively.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Single-centre, double-blind, placebo-controlled, randomised study.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Low protein diet; Chronic kidney disease; Gut microbiota; Microbial uremic toxins; Probiotic bacteria; Intestinal dysbiosis
Platelet Rich Fibrin and Concentrated Growth Factors on Osseointegration of Immediate Implants
Condition: Tooth Extraction; Dental Implants
Study type: Interventional

Summary: 
      This study will involve 14 patients with mandibular premolars indicated for extraction and
      immediate replacement. The patients will be randomly allocated into two groups and each
      patient will receive one implant. In Group A, a CGF membrane will be laid in the implant
      cavity. While in Group B, a PRF membrane will be laid in the implant cavity. Bone graft
      material will be applied to fill the empty parts of the socket.

      Resonance frequency measurement will be done using the OSTELL device intraoperatively, at the
      1st week and after 3 months. Cone-beam computed tomography will be done preoperatively,
      immediately following surgery, and after 3 months
    


Intervention name(s): Concentrated Growth Factors (CGF); Platelet-Rich Fibrin (PRF)
Intervention type(s): Procedure; Procedure
Intervention description(s): Concentrated Growth Factors membrane will be laid in the implant cavity. Bone graft material will be applied to fill the empty parts of the socket.; Platelet-Rich Fibrin (PRF) membrane will be laid in the implant cavity. Bone graft material will be applied to fill the empty parts of the socket.
Intervention MeSH terms: Mitogens
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
A Dose Escalation Study to Assess Safety, Tolerability and Pharmacokinetics of ASP2409 Following a Single Intravenous Dose in Patients With Rheumatoid Arthritis on Methotrexate
Condition: Rheumatoid Arthritis; Pharmacokinetics of ASP2409
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety, tolerability and pharmacokinetics (PK) of
      single, ascending, intravenous (IV) doses of ASP2409 in patients with Rheumatoid Arthritis
      (RA) on methotrexate (MTX) and to evaluate the pharmacodynamics (PD) of ASP2409.
    

Detailed description: 
      This is a dose-escalation study. Sequential cohorts of subjects will receive increasing doses
      of ASP2409 or matching placebo.

      Subjects in all cohorts will stay confined in the unit for 3 days. All subjects will have
      scheduled outpatient visits and be followed for a minimum of 90 days.
    

Intervention name(s): ASP2409; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): intravenous (IV); intravenous (IV)
Intervention MeSH terms: ASP2409
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ASP2409; Rheumatoid Arthritis; methotrexate
D-0316 First Time in Patients Ascending Dose Study
Condition: Advanced Non Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase 1 open label multicentre study of D-0316 administered orally in patients with
      advanced NSCLC who have progressed following prior therapy with an EGFR-TKI (Epidermal Growth
      Factor Receptor tyrosine kinase inhibitor agent). This is the first time this drug has ever
      been tested in patients, and so it will help to understand safety, tolerability,
      pharmacokinetics and preliminary anti-tumour activity of ascending doses of D-0316.
    


Intervention name(s): D-0316
Intervention type(s): Drug
Intervention description(s): If initial dosing of D-0316 is tolerated then subsequent cohorts will test increasing doses until a maximum tolerated dose or maximum feasible dose is defined
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study on the Effects of Nutritious Mushrooms in Adults With Metabolic Syndrome
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional

Summary: 
      Obesity, characterized by an increase in body weight that results in excessive fat
      accumulation, is a global health problem. Recently, it has also been shown that obesity is
      associated with low-grade chronic systemic inflammation in adipose tissue. This condition is
      mediated by activation of the innate immune system in adipose tissue that promotes
      inflammation and oxidative stress and triggers a systemic acute-phase response.

      Previous research points towards the potential of phytochemicals in food as part of
      nutritional strategies for the prevention of obesity and associated inflammation, as well as,
      increase in insulin sensitivity in diabetic patients.

      In addition, there is strong evidence that obesity is inversely associated with vitamin D
      levels. The major cause of vitamin D deficiency in humans is the lack of adequate sun
      exposure. Unfortunately, very few foods, i.e. mushrooms, naturally contain vitamin D and
      foods that are fortified with vitamin D are inadequate to satisfy vitamin D requirements.

      The last decade, mushrooms have attracted the research interest as functional foods with
      desirable health benefits in several metabolic disorders without the side effects of
      pharmacological treatment. Edible mushrooms are highly nutritious and exhibit beneficial
      effects on several inflammatory diseases such as cancer, heart disease, diabetes,, high blood
      pressure.

      Thus, the purpose of this study is to determine the effects of nutritious mushrooms in adults
      with Metabolic Syndrome. More specifically, 100 participants will be allocated to two groups,
      namely intervention group (N=50) and control group (N=50). Vitamin D2-enhanced mushrooms by
      UV-B will be provided as a snack to the intervention group, whereas the control group will
      not consume the snack. The intervention will last 3 months.The effects of the intervention
      will be evaluated via clinical and laboratory markers. Personal and family history,
      anthropometric, demographic data, body composition, dietary habits, physical activity and
      smoking status will be assessed pre- and post- intervention. Biochemical profile, oxidative
      stress and inflammation, as well as metabolomic profiles will be assessed in blood samples
      pre- and post- intervention. Both groups will receive standard nutritional counselling
      throughout the intervention and will be encouraged to report any adverse effects they may
      experience during the intervention.
    


Intervention name(s): Nutritious Mushrooms
Intervention type(s): Other
Intervention description(s): The Intervention group will consume antioxidant rich and Vitamin D2-enhanced mushrooms as a snack daily for 3 months.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Assessing the Minimal Important Difference (MID) of the Treatment Related Impact Measure-Adult Growth Hormone Deficiency (TRIM-AGHD)
Condition: Growth Hormone Disorder; Adult Growth Hormone Deficiency
MeSH terms: Dwarfism, Pituitary; Endocrine System Diseases
Study type: Observational

Summary: 
      This study is conducted in the United States of America (USA). The aim of the study is to
      assess the minimal important difference (MID) of the TRIM-AGHD.
    


Intervention name(s): No treatment given
Intervention type(s): Other
Intervention description(s): Subject will only fill out a questionnaire when entering the non-interventional study
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult patients with a diagnosis of growth hormone deficiency (GHD), naïve to treatment
        currently and for at least 6 months prior, who are beginning a new prescription treatment
        for their GHD. Patients will be selected by sites as per inclusion and exclusion criteria
Efficacy and Safety of Nilotinib in Patients With a Chronic Disease of the Graft Against the Host
Condition: Graft Versus Host Disease
MeSH terms: Graft vs Host Disease; Chronic Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      Open label non-randomized multicenter phase 2 trial with direct individual benefice
    

Detailed description: 
      Induction phase: Imatinib mesylate - starting with 100 mg/day with increase of 100 mg/day
      each other week up to maximum tolerable dose or 400 mg/day whichever occurred first. For the
      responders and in absence of toxicity, the treatment will be maintained up to one year.
      Patients, who discontinue imatinib mesylate at 3 months for lack of response (no response =
      stable disease), those who experience progression at any time, those who relapse after an
      initial response at any time or those who discontinue for toxicity at any time, will go to
      the salvage phase.

      Salvage phase:

      Nilotinib - starting with 200 mg/day with increase of 200 mg/day each other week up to
      maximum tolerable dose or 800 mg/day whichever occurred first. In absence of toxicity, the
      treatment will be maintained up to one year.
    

Intervention name(s): Imatinib Mesylate and Nilotinib
Intervention type(s): Drug
Intervention description(s): For patients under Imatinib Mesylate: the total length of follow up period for those patients will be for 52 weeks following IM treatment, with a follow up at weeks IM4, IM8, IM12, IM26, IM38 and IM52.
For patients requiring a salvage phase: after the switch for nilotinib, the total length of follow up period for this phase will be for 52 weeks following nilotinib treatment, with a follow up at weeks nilo4, nilo8, nilo12, nilo26, nilo38 and nilo52.
Intervention MeSH terms: Imatinib Mesylate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: allogeneic stem cell transplantation; imatinib Mesylate; Nilotinib
Motivating Quitline Use Among Smokers in Treatment for Substance Use Disorders
Condition: Smoking Cessation
Study type: Interventional

Summary: 
      The long-term goal of this program of research is to disseminate an effective, brief
      computer-based intervention that can be readily integrated into Substance Use Disorders (SUD)
      treatment programs to motivate tobacco quitline use in patients who smoke. The overall
      objective of this application, which is the first step in the attainment of this long-term
      goal, is to fully develop this computer-based intervention, modify it based on initial
      piloting and feedback to insure its feasibility and acceptability, and obtain preliminary
      data supporting the efficacy of the intervention. This will be accomplished by pursuing three
      specific aims: 1) to develop and conduct preliminary pilot testing (n=20) of a brief,
      computer-based intervention intended to motivate tobacco quitline use among cigarette smokers
      in SUD treatment (TIME-TQ; Tablet computer Intervention to Motivate Engagement in Tobacco
      Quitline use) and to develop and pilot test a computer-based, time matched control
      intervention (CON), 2) to conduct a preliminary randomized controlled trial (RCT) with 60
      smokers in SUD treatment, comparing TIME-TQ vs. CON, with predictions that TIME-TQ relative
      to CON will result in increased readiness, higher rates of tobacco treatment engagement, more
      quit smoking attempts and higher rates of 7-day point prevalence abstinence rates at 1- and
      3-month follow-ups. Substance use outcomes over the course of the 3-month follow-up period
      will also be examined, and 3) to examine TIME-TQ's effects on key mechanisms during the
      computer session and their associations with tobacco treatment engagement and smoking
      outcomes at 1- and 3-month follow-ups.
    


Intervention name(s): Brief Computer Motivational Interviewing for Smoking Cessation; Nutrition Control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Brief computer motivational interviewing intervention to motivated tobacco quitline use; Computer delivered nutrition education control condition
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Tobacco; nicotine; dependence; quitline
Concentrate of Autologous Rich Plasma in Growth Factors in the Treatment of the Thin Endometrium
Condition: Infertility; Infertility, Female
MeSH terms: Infertility; Infertility, Female
Study type: Interventional
Phase: Phase 2

Summary: 
      This study evaluate the percentage of women with thin endometrium who achieve an endometrial
      thickness equal to or greater than 7 mm after administration of PRGF (plasma rich in growth
      factors)
    


Intervention name(s): Plasma rich in growth factors (PRGF-Endoret)
Intervention type(s): Drug
Intervention description(s): Intrauterine administration of PRGF
Intervention MeSH terms: Mitogens
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Trial on Effectiveness Combined Probiotics in Atopic Dermatitis in Children
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 4

Summary: 
      Atopic dermatitis (AD) is an immune disorder, characterized by chronic skin inflammation or
      relapsing, whose prevalence is increasing worldwide. Its exact etiology remains unknown. The
      hypothesis that an appropriate early stimulation of the intestinal flora contributes to the
      establishment of the immune system balance has led to the use of probiotics in the prevention
      and treatment of AD in several clinical and experimental studies.

      Therefore, the objectives of this study will evaluate the clinical efficacy of the mixture of
      probiotics (Lactobacillus and Bifidobacterium) in children with AD through the SCORAD
      (scoring atopic dermatitis) and to evaluate the effects of this medication in the following
      laboratory parameters: skin prick test, total serum immunoglobulin E (IgE), inflammation
      composite (interferon gamma [ɣ - IFN], interleukins [IL1-β, IL-4, IL-6, IL-8] and tumor
      necrosis factor alpha) and immune tolerance composite (IL-10, IL-17 and transforming growth
      factor beta [TGF - β]).
    


Intervention name(s): Probiatop; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Dilute one sachet in 100ml of water and take it in every morning, once a day for 6 months.; 1 sachet, once a day for 6 months. Dilute one sachet in 100ml of water and take it in every morning.
Other intervention name(s): Probiotics; Maltodextrin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Probiotics; Inflammation; Awareness; Immune tolerance
Study to Assess Efficacy,Safety and Tolerability of Idebenone in the Treatment of Leber's Hereditary Optic Neuropathy
Condition: Leber's Hereditary Optic Neuropathy
MeSH terms: Peripheral Nervous System Diseases; Optic Nerve Diseases; Optic Atrophy, Hereditary, Leber
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is meant to assess the effectiveness of idebenone on visual function measures in
      patients with Leber's Hereditary Optic Neuropathy over a 6 months period.
    

Detailed description: 
      The study involves 6 clinic visits.
    

Intervention name(s): Idebenone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Idebenone 900 mg/day; Placebo
Intervention MeSH terms: Idebenone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Leber; LHON; Leber's Hereditary Optic Neuropathy; Idebenone
Evaluation of the Position of Promontofixation Prostheses in Perineal Ultrasound
Condition: Prolapse of the Uterus
MeSH terms: Prolapse
Study type: Interventional

Summary: 
      Indirect promontofixation with prostheses is the standard surgical technique for the
      reference of uterine prolapse. There is no validated examination to control the position of
      the prostheses postoperatively.

      These prostheses are echogenic and perineal ultrasound could be a means of postoperative
      monitoring. There is no data in the literature on the relationship between prosthesis
      position and postoperative symptoms
    


Intervention name(s): perineal ultrasound
Intervention type(s): Other
Intervention description(s): Ultrasound measurement of the size and position of the prostheses.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Studying Cognition in SPG4
Condition: Cognitive Impairment; Hereditary Spastic Paraplegia
MeSH terms: Paraplegia; Spastic Paraplegia, Hereditary
Study type: Observational

Summary: 
      Comparing the cognitive levels of patients with SPG4 mutations to healthy controls.
    

Detailed description: 
      Comparing the cognitive levels of patients with SPG4 mutations to healthy controls by using
      the CANTAB® and MoCA.
    

Intervention name(s): CANTAB; MOCA
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): CANTAB Cognitive Assessment (tablet based cognitive testing from CAMCOG); Montreal cognitive assessment (MOCA) in German
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Probands will be recruited at the HSP Outpatient Clinic of the Department of Neurology in
        Tübingen. Eligible participants are age 18 to 70 years of age. Group 1 include p: patients
        with genetically confirmed SPG4 (group 1) and manifest disease with spastic gait disorder.
        Group 2 includes age- and sex-matched and healthy controls (spouses, other relatives or
        further healthy controls) with an educational level comparable to group 1 (group 2).
Efficacy and Tolerability of Topical Rossoseq™ Compared to Vehicle in Rosacea Subtype 1 (Erythematotelangiectatic)
Condition: Rosacea Subtype 1 (Erythematotelangiectatic)
MeSH terms: Rosacea
Study type: Interventional

Summary: 
      Rossoseq™ is registered for the treatment of inflammatory skin conditions. Rosacea is one
      such inflammatory skin disorder that has not been studied yet for the use of Rossoseq™.
      Whilst rosacea is showing features of an inflammatory skin disorder [1], particularly stage 1
      is poorly understood and treatment options are limited and therefore this study - within the
      target indication - will contribute to the learning about rosacea.
    

Detailed description: 
      Male or female subjects ≥18 and < 85 years with a clinically diagnosed rosacea subtype 1
      (erythematotelangiectatic) defined by a score of 6-15 for the primary and secondary features
      of the rosacea standard grading system (RSGS; Wilkin et al, 2004) will be enrolled.

      The study will consist of a Screening visit, Baseline visit (Week 0), a telephone call at
      Week 1, visits at Week 2 and 4, and a follow-up telephone call at Week 5. Eligible subjects
      may or may not be using medication for their rosacea at the time of screening. Subjects with
      concomitant use of rosacea treatments will be taken off their current medication and will
      return for a Baseline Visit at the end of the wash-out period.

      Eligible subjects will be stratified by gender at a ratio of 4:1 (Female: Male). Within the
      strata, subjects will be randomised at Baseline in a 2:1 ratio in favour of Rossoseq™ to
      receive either Rossoseq™ or vehicle.

      Efficacy will be evaluated using subject rating of the rosacea specific quality of life
      instrument (R-QOL; Nicholson et al, 2007) during office visits and applied over the phone
      during the week 1 and follow-up telephone call at Week 5. An investigator rating will be
      performed using a "0=absent" to "3=severe" grading of the RSGS primary features flushing,
      nontransient erythema, papules and pustules, telangiectasia and the secondary features
      burning or stinging, plaques, dry appearance, edema, ocular manifestations and phymatous
      changes during the office visits. Ocular manifestations and phymatous changes need to be
      absent to be eligible for the study.

      Photographs to document treatment effects will be taken at screening, baseline, week 2 and
      week 4.
    

Intervention name(s): Rossoseq™; Placebo
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment