bioihbjkbjnl/mcl2 huggingface dataset:
Modulation of Bifidocentric Dysbiosis Through Bifidobacterium Bifidum PRL2010 Supplementation in Caesarian-born Infants
Condition: Disbiosis
MeSH terms: Dysbiosis
Study type: Interventional

Summary: 
      This study is aimed to manipulate the composition of the intestinal flora of the infants born
      by caesarian section through the administration of the probiotic strain "Bifidobacterium
      bifidum PRL 2010", in order to evaluate its effects on gut dysbiosis during the first 6 month
      of life.
    

Detailed description: 
      There has been increasing interest in the field of human microbiome, considering its impact
      on health and diseases. The gastrointestinal tract represents the most heavily inhabited
      organ with microorganisms, counting 10 times the total number of human cells; for this
      reason, the gut microbiome has recently been referred as a proper organ. Intestinal microbial
      composition is unique for each individual and it is influenced by numerous factors, of which
      delivery mode is an important one with gestational age of the newborn, type of feeding and
      intrapartum or neonatal antibiotic therapy. Recent reports suggest that dysbiosis secondary
      to delivery mode affects the subsequent regulation of immune response and may be associated
      with several pathologic conditions, for example allergic diseases or obesity. Moreover, gut
      microbiome seems to impact on neurodevelopment during first six months of life.
      Bifidobacteria is the most represented group of intestinal microbiota in the newborn,
      followed by Enterobacteria, and it plays an important role in the infant gut. This includes
      the fundamental function performed by Bifidobacterium bifidum: it supplies the nutritional
      material to the rest of the microbial community, particularly Bifidobacterium breve and
      Bifidobacterium longum infantis that are the other typical bifidobacteria of the newborn. It
      is a powerful metabolizer of the intestinal mucus and the HMOs (Human Milk Oligosaccharides)
      present in breast milk. Thanks to its exocitable enzymes, the degradative catabolism occurs
      in the intestinal environment. Thus, B. bifidum favour the increase in intestinal richness
      and biodiversity (9), which correlates with the host's state of health. However,
      bifidobacteria is reduced in infants born by cesarean delivery.

      Aim of the study is to assess if the Bifidobacterium Bifidum PRL2010 supplementation
      effectively ameliorat bifidocentric dysbiosis due to the delivery mode and we want to confirm
      this by analyzing fecal microbiota in caesarean birth infants.
    

Intervention name(s): Probiotic Bifidobacterium Bifidum PRL2010; Control group
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Probiotic supplement; No probiotic supplementation
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Probiotic Bifidobacterium Bifidum PRL2010
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy and Tolerability of Nicotinamide Plus Cream for Moderate Acne Vulgaris in Indonesia
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 4

Summary: 
      Acne vulgaris (AV) is a chronic inflammatory disease of the pilosebaceous unit that affects
      seborrheic areas such as the face, back and chest. AV is characterized by blackheads,
      papules, pustules nodes and cysts with sequelae of hyperpigmentation and scarring. It is one
      of the most common skin disorders treated by dermatologists. Acne vulgaris can be found at
      any age, although it is more frequent in teenagers and young adults. The prevalence of AV in
      a population of 11 to 30 years old is approximately 80%. Due to its involvement of the face,
      it is considered to be a cosmetic problem, thus bearing a psychosocial burden.
    


Intervention name(s): Adapalene; Nicotinamide, ABA and Zinc PCA; Placebos
Intervention type(s): Drug; Drug; Drug
Intervention description(s): third-generation topical retinoid primarily used in the treatment of mild-moderate acne. It is effective against acne conditions where comedones are predominant.; combination of three non-antibiotic active ingredients of nicotinamide, anti-bacterial adhesive agent (ABA) and zinc, or abbreviated as ANAZ to be well-tolerated by patients with acne vulgaris; Placebo cream. to resemble an active medication or therapy so that it functions as a control; this is to prevent the recipient(s) and/or others from knowing (with their consent) whether a treatment is active or inactive, as expectations about efficacy can influence results.
Intervention MeSH terms: Niacinamide; Niacin; Nicotinic Acids; Adapalene
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
PLATELET RICH FIBRIN COMBINED WITH 1.2% ATORVASTATIN FOR TREATMENT OF INTRABONY DEFECTS IN CHRONIC PERIODONTITIS
Condition: Periodontitis
MeSH terms: Periodontitis
Study type: Interventional
Phase: Phase 2

Summary: 
      Current study was designed to evaluate the combined efficacy of PRF and 1.2% ATV gel with
      open flap debridement (OFD) in treatment of intrabony defects in chronic periodontitis
      subjects.
    


Intervention name(s): Platelet rich fibrin +Atorvastatin; Platelet rich fibrin; open flap debridement
Intervention type(s): Drug; Drug; Procedure
Intervention MeSH terms: Atorvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Periodontitis; Surgery; Growth Factors; Statins
The Effects of Enzyme-rich Malt Extract on Chronic Constipation
Condition: Constipation; Quality of Life; Methane Production
MeSH terms: Constipation
Study type: Interventional

Summary: 
      Participants with constipation will take enzyme-rich malt extract for 4 weeks whilst
      completing a daily bowel habit diary before and during intervention.
    

Detailed description: 
      This pilot study is an open label, pre-post interventional study to evaluate the use of ERME
      in the treatment of people with chronic constipation.

      This study involves eligible participants that have a diagnosis constipation according to the
      Knowles-Eccersley-Scott Score (KESS). Participants will receive intervention with a food
      supplement enzyme-rich malt extract (ERME) at a dose of 15ml twice daily with food.

      Before intervention commences, participants will complete baseline breath samples and a 7 day
      stool diary to assess stool frequency and consistency.

      Participants will then receive the ERME as instructed and continue to complete a bowel diary.
      Then at 4 weeks since starting the intervention, participants will provide another breath
      sample and complete another set of breath samples.
    

Intervention name(s): Enzyme-rich malt extract
Intervention type(s): Dietary Supplement
Intervention description(s): Enzyme-rich malt extract (ERME) is a by-product of the malting process in which the cereal grain barley is dried. The ingredients are 100% barley malt extract. It smells and tastes sweet, with a runny jam-like texture. Malt extract has been used as a food stuff in baking and cookery for many years, but ERME is extracted by means which retains more active enzymes, such as amylase.
Intervention model: Single Group Assignment
Intervention model description: Prospective Cohort
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Constipation
Cognitive Functioning Related to Job Tenure Among Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Observational

Summary: 
      The aim of this research is to explore which cognitive function would affect the job tenure
      among people with schizophrenia. The investigators plan to recruit 60 people diagnosed with
      schizophrenia and divide into two groups, employment and unemployment. The investigators will
      use several cognitive function tests to collect their cognitive functions and PANSS to
      evaluate their psychotic symptoms. And then the investigators will compare and analysis the
      data through statistic software. Finally, the investigators will have the answer about if
      cognitive functions would affect the job tenure among people with schizophrenia. And the
      investigators hope that we could get the predict factor of cognitive function to predict the
      successful employment in future.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        schizophrenia
CP-690,550 And Oral Contraception Drug-Drug Interaction Study
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to assess whether co-administration of CP-690,550 and oral
      contraceptives will effect the metabolism of the oral contraceptives in healthy volunteers.
    


Intervention name(s): ethinyloestradiol (EE) and levonorgestrel (LN), CP-690,550 + ethinyloestradiol (EE) and levonorgestrel (LN); CP-690,550 + ethinyloestradiol (EE) and levonorgestrel (LN), ethinyloestradiol (EE) and levonorgestrel (LN)
Intervention type(s): Drug; Drug
Intervention description(s): Period 1: 30 mcg ethinyloestradiol and 150 mcg levonorgestrel alone Period 2: 30 mcg ethinyloestradiol and 150 mcg levonorgestrel plus 30 mg CP-690,550 after 9 days of CP-690,550 at 30 mg BID; Period 1: 30 mcg ethinyloestradiol and 150 mcg levonorgestrel plus 30 mg CP-690,550 after 9 days of CP-690,550 at 30 mg BID Period 2: 30 mcg ethinyloestradiol and 150 mcg levonorgestrel alone
Intervention MeSH terms: Levonorgestrel; Ethinyl Estradiol; Tofacitinib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: drug interactions; CYP3A; oral contraceptive; anti-rheumatic agents
Corneal Biomechanics With Hydration in Normal and LASIK Eyes
Condition: Laser Corneal Surgery
Study type: Interventional

Summary: 
      The research will utilize LASIK and non-LASIK populations to analyze the biomechanical
      differences between these corneas.
    

Detailed description: 
      The research will utilize LASIK and non-LASIK populations to analyze the biomechanical
      differences between these corneas. Subjects' corneas will be swelled with warmed, humidified
      nitrogen using modified diving goggles to assess structural changes due to a two hour
      swelling period. Subjects will be examined prior to swelling by a registered ophthalmologist
      to ensure that the cornea is healthy enough to undergo the swelling procedure. Pre-swelling
      and post-swelling data will be compared for parameters such as elasticity, density,
      thickness, axial and tangential curvature, hydration, and intraocular pressure in the
      central, paracentral, and peripheral regions. Analysis of pre-swelling and post-swelling data
      will allow for a better understanding of the structural changes created by LASIK. In
      addition, this project will allow for a better understanding of how common fluctuations in
      hydration levels affect normal corneal parameters as given by common devices in both
      populations to allow for corrections for more accurate measurements.
    

Intervention name(s): LASIK surgery; No Intervention
Intervention type(s): Procedure; Other
Intervention description(s): Participants have received LASIK surgery and their eyes are healthy.; Participant has healthy eyes not altered by LASIK surgery.
Other intervention name(s): Refractive Surgery; Normal cornea; no refractive surgery
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: LASIK vs. non-LASIK
Autonomic Nervous System Dysfunction and Peripheral Neuropathy in a Cohort of Asymptomatic Juvenile Diabetic Patients (Type I): A Case-Controlled Study
Condition: Peripheral Neuropathy; Autonomic Neuropathy
MeSH terms: Peripheral Nervous System Diseases
Study type: Observational

Summary: 
      This is a case-controlled study using an innovative, non-invasive, FDA approved technology to
      measure the autonomic nervous system. Detection of unsuspected DPN or ANS dysfunction may
      allow physicians to re-assess current treatment and develop new dietary or pharmacological
      strategies. This also is an immense public health concern since there are currently 18
      million diabetics in the United States and 220 million worldwide.
    

Detailed description: 
      A consecutive cohort of 20 neurologically asymptomatic (absence of numbness, tingling,
      burning or pain in the feet) patients with Type I from the practice of Dr. Richard Noto
      (gatekeeper) and associates will be asked with their legal guardians to enroll in this
      case-controlled study using a battery of safe, neurological tests which are unlikely to be
      painful. A second group of 20 subjects who are nondiabetic and healthy (age/sex matched) will
      also be enrolled and undergo the same battery of neurological tests. The battery of tests is
      highly accurate, objective and safe. Subjects will be referred and enrolled from the private
      practices of community pediatricians. A BMI derived from the subject's height and weight will
      be assessed by Dr. Noto. Subjects who are felt to be acceptable by the inclusion criteria
      will then receive consecutive numbers from 1 to 40 and their initials will follow their
      specific number for each study.
    

Observational model: Case-Control
Time perspective: Prospective
Antagonist Protocol in Poor Responders
Condition: Female Infertility Due to Diminished Ovarian Reserve
MeSH terms: Infertility; Infertility, Female
Study type: Interventional
Phase: Phase 4

Summary: 
      The effect of use of the growth hormone with antagonist protocol on the outcome of the
      IVF/ICSI cycles in poor responders.
    

Detailed description: 
      Two groups of poor responder female patients planned to receive the antagonist IVF/ICSI
      protocol are randomized to whether or not to add growth hormone to their protocol.
    

Intervention name(s): Growth Hormone
Intervention type(s): Drug
Intervention description(s): Growth hormone (Norditropin, Novo nordisk) was administrated on day 6 of HMG stimulation daily in a dose of 2.5 mg S.C. till the day of hCG administration.
Other intervention name(s): Norditropin, Novo nordisk
Intervention MeSH terms: Hormones
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Growth hormone; IVF/ICSI; Poor responder; Antagonist protocol
Study the Role of Stem Cell in Curing Drug Induced Liver Injury in Metastatic Breast Cancer (MBC)
Condition: Breast Neoplasms; Neoplasm Metastasis
MeSH terms: Neoplasms; Neoplasm Metastasis; Breast Neoplasms; Chemical and Drug Induced Liver Injury
Study type: Observational

Summary: 
      The investigators want to know the role of Peripheral hematopoietic stem cell infusion in
      avoiding Drug Induced Liver Injury,and also try to research SNPs genotyping associated with
      Drug Induced Liver Injury.
    

Detailed description: 
      1. The researcher investigate the incidence and the cause of Drug Induced Liver Injury in
           MBC.

        2. Patients having a complete clinical history and physical examination, receive routine
           chemotherapy.

        3. Venous blood Sample(4 ml)is collected before and after each cycle according to the
           planning time.

        4. Genomic DNA,RNA and upper serum is isolated. ELISA、rt-PCR or PCR-direct sequencing is
           used to detect the protein or gene expression associated with liver function.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        female patients with metastatic breast cancer
      
Biospecimen description: 
      patients' blood sample
    
Keywords: breast neoplasm; Neoplasm Metastasis; Stem Cells; Drug-Induced Liver Injury
Neuromuscular Electrical Stimulation (NMES) and Muscle Protein Accretion (ES-PRO)
Condition: Sarcopenia
MeSH terms: Sarcopenia
Study type: Interventional

Summary: 
      In the present study, the effect of a bolus of intrinsically labeled milk directly after
      one-legged NMES will be studied.
    


Intervention name(s): Enraf Nonius Tensmed S84 for Neuromuscular electrical stimulation (NMES); No Enraf Nonius Tensmed S84 for Neuromuscular electrical stimulation (NMES) NMES
Intervention type(s): Device; Device
Intervention description(s): One our of one-legged neuromuscular electrical stimulation (NMES); No neuromuscular electrical stimulation (NMES) will be applied in the control leg
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Neuromuscular Electrical Stimulation; Ageing; Protein ingestion
To Evaluate the Efficacy and Safety of CAEP-01 on Eye Strain in Children With Heavy Screen Use
Condition: Vision Disorders
MeSH terms: Vision Disorders; Asthenopia
Study type: Interventional

Summary: 
      Several recent clinical trials have highlighted the potential role of Product in promoting
      eye health.product whose structural and functional characteristics make it a promising
      bioactive compound in the prevention of several human diseases as well as in the maintenance
      of a good health status. it might relieve eyestrain in people using computer monitors as
      suggested who conducted a double-blind randomized clinical trial by enrolling visual display
      terminal workers and prescribed them product or placebo. Study outcomes were objectively
      evaluated by using a proper instrumentation to measure eye muscle endurance. Subjects
      receiving Product experienced a significant relief from eyestrain compared to the placebo
      group.
    


Intervention name(s): CAEP-01; Placebo
Intervention type(s): Other; Other
Intervention description(s): Dose: 1 capsule Route: orally for 84 ± 3 days Regimen: one capsule before breakfast (preferably with milk/butter/ghee); Dose: 1 capsule Route: orally for 84 ± 3 days Regimen: one capsule before breakfast (preferably with milk/butter/ghee)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: CAEP-01, Placebo Dose: 44 mg/day Route: orally for 84 ± 3 days Regimen: one capsule before breakfast (preferably with milk/butter/ghee)
Masking: Double (Participant, Investigator)
Primary purpose: Other
Patients With Acl Injury and Varus Knee Will Undergo Acl Reconstruction Alone, or Combined With High Tibial Osteotomy in the Same Session.
Condition: ACL - Anterior Cruciate Ligament Deficiency; Varus Deformity of Tibia (Disorder); ACL Injury; Knee Deformity
MeSH terms: Congenital Abnormalities; Anterior Cruciate Ligament Injuries
Study type: Interventional

Summary: 
      The purpose of this study is to compare the results of single-stage anterior cruciate
      ligament reconstruction combined with high tibial osteotomy and anterior cruciate ligament
      reconstruction alone in knees with varus malalignment and anterior cruciate ligament
      deficiency. Evaluation will be clinically, radiologically and time needed to return to pre
      injury activity level. Our Hypothesis: Simultaneous anterior cruciate ligament reconstruction
      and high tibial osteotomy provides good functional scores, low rate of graft failure and
      early return to pre injury activity level with minimal added morbidity.
    


Intervention name(s): medial opening wedge high tibial osteotomy; anterior cruciate ligament reconstruction
Intervention type(s): Procedure; Procedure
Intervention description(s): medial opening wedge valgus high tibial osteotomy; anterior cruciate ligament reconstruction
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of Tocilizumab in Combination With Methotrexate for Treatment of Moderate to Severe Rheumatoid Arthritis Patients
Condition: Rheumatoid Arthritis (RA)
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a Phase III study to evaluate efficacy and safety of Tocilizumab in patients with
      Rheumatoid Arthritis.
    


Intervention name(s): Tocilizumab + methotrexate(MTX); Tocilizumab placebo + methotrexate(MTX)
Intervention type(s): Drug; Drug
Intervention description(s): Tocilizumab:8 mg/kg every4weeks,IV infusion methotrexate:10-20 mg/week; Tocilizumab placebo:8 mg/kg every 4 weeks,IV infusion methotrexate:10-20 mg/week
Intervention MeSH terms: Methotrexate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Tauroursodeoxycholic Acid for Protease-inhibitor Associated Insulin Resistance
Condition: HIV Related Insulin Resistance; Protease Inhibitor Related Insulin Resistance; Endoplasmic Reticulum Stress
MeSH terms: Insulin Resistance
Study type: Interventional

Summary: 
      Rates of cardiovascular disease and diabetes are more than 2-fold greater in HIV infected
      people than the general population. Protease inhibitor booster antiretroviral therapy
      (PI-ART) which is used by ~50% of HIV infected people in the USA is an established risk
      factor for diabetes. Tauroursodeoxycholic acid (TUDCA), a naturally occurring bile salt,
      improves insulin sensitivity in HIV uninfected subjects, although the mechanisms for these
      benefits are unclear. This study will explore the hypothesis that TUDCA will improve insulin
      action in people with HIV who are receiving PI-ART. Further, this project will clarify the
      molecular mechanisms responsible for these improvements potentially benefiting society,
      irrespective of HIV status.
    

Detailed description: 
      The purpose of this study is to determine if, and through which mechanisms,
      tauroursodeoxycholic acid improves insulin sensitivity in subjects with protease-inhibitor
      associated insulin resistance.

      The investigators will perform body composition analysis by using a DEXA machine, liver fat
      measurement by using an MRI, and hyperinsulinemic euglycemic clamp procedures in 48 HIV
      infected, insulin-resistant/prediabetic subjects before and after 30 days of treatment with
      tauroursodeoxycholic acid or matching placebo. Biopsies of adipose tissue and skeletal muscle
      will be taken during fasting conditions and during insulin infusion, before and after
      treatment to measure markers of endoplasmic reticulum stress and thyroid hormone deiodinase.

      Outcome measures:

      The primary outcome measures will be change in glucose clearance during insulin infusion,
      change in markers of endoplasmic reticulum stress and change in content of D2 in muscle.
    

Intervention name(s): Tauroursodeoxycholic acid; Placebo tablet
Intervention type(s): Drug; Other
Intervention description(s): The intervention group will receive 1.75 grams of tauroursodeoxycholic acid daily for 30 days.; The placebo group will receive a placebo tablet that is identical to the treatment group except that it does not contain tauroursodeoxycholic acid. The pills will be taken once daily for 30 days.
Other intervention name(s): taurolite; tudcabil
Intervention MeSH terms: Ursodoxicoltaurine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: HIV; Protease inhibitor; insulin resistance; Tauroursodeoxycholic acid