bioihbjkbjnl/mcl2 huggingface dataset:
Corn and Heart Health Study
Condition: Gut Microbiome; Cholesterol, LDL; Cholesterol, HDL
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the effects of 3 different corn flours: (1) whole
      grain corn flour, (2) 50% refined corn flour + 50% corn bran derived from whole corn meal,
      and (3) refined corn flour, on cardio-metabolic outcomes and changes in the gut microbiome.
    

Detailed description: 
      Dietary fibers are extremely complex and foster health in a variety of ways that are not
      fully understood. The Adequate Intake of fiber (14 g per 1000 kcal consumed) is based on data
      that strongly support a relationship with cardiovascular disease prevention (Slavin, 2013).
      While cereal fibers have been shown to be most effective at reducing cardiovascular disease
      risk (IOM, 2002), the components of dietary fiber (e.g. germ, bran) that exert this effect
      remain inadequately studied in cardiometabolic outcomes. Further, specific types of dietary
      fiber (natural and synthetic) have been shown to increase beneficial microbial species in the
      gastrointestinal tract, which are accompanied by improvements in inflammatory and metabolic
      disease markers. Very little is known about how isolated or intact fiber in whole grains
      solicit beneficial health effects via microbial mechanisms. Our goal is to study both changes
      in cardiometabolic outcomes and the gut microbiome after consuming different types of
      corn-based meals.

      Aim 1: To evaluate cardio-metabolic outcomes (primary outcome: LDL cholesterol) after
      consuming 48 g/d of whole grain corn flour, 50% refined corn flour + 50% corn bran derived
      from whole corn meal, and refined corn flour for 4 weeks in adult males and females with
      elevated LDL cholesterol in a crossover design.

      Aim 2: To evaluate changes in the gut microbiome after consuming 48 g/d of whole grain corn
      flour, 50% refined corn flour + 50% corn bran derived from whole corn meal, and refined corn
      flour for 4 weeks in adult males and females with elevated LDL cholesterol in a crossover
      design.
    

Intervention name(s): Refined cornmeal flour; 50/50 refined cornmeal-bran mix; Whole grain cornmeal flour
Intervention type(s): Other; Other; Other
Intervention description(s): 48 g/d of refined cornmeal flour served to participants as two daily 24 g servings via pita breads and/or muffins; 48 g/d of a mix of 50% refined cornmeal flour and 50% corn bran flour served to participants as two daily 24 g servings via pita breads and/or muffins; 48 g/d of whole grain cornmeal flour served to participants as two daily 24 g servings via pita breads and/or muffins
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: cholesterol; gut microbiome; gut microbiota; dietary fiber; whole grain
Subcutaneous Progesterone Versus Vaginal Progesterone for Endometrial Preparation in Fresh Donated Oocytes Recipients
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 4

Summary: 
      Randomised, prospective, investigator-blinded, controlled, single-centre study to assess the
      impact on the ongoing pregnancy rate with the use of two progesterones with different
      administration routes, in recipients of fresh embryos from donor oocytes, undergoing
      endometrial preparation for fresh embryo transfer.
    

Detailed description: 
      Exploratory study with a control group treated according to our Service's usual therapeutic
      regimen for the transfer of embryos with donor oocytes.

      The controlled ovarian stimulation protocol in oocyte donors is always calculated according
      to the standard protocol at the Bernabeu Institute. Endometrial preparation will be carried
      out following the standard protocol of the Bernabeu Institute as follows: the oestrogen will
      be administered transdermally and patients with maintained ovarian function undergo medical
      hypophysectomy with depot GnRH agonists administered in the mid-luteal phase of the previous
      cycle.

      On the day of oocyte retrieval, the patient will be randomised: Group A will be administered
      subcutaneous progesterone 25 mg/day (Prolutex), and Group B will be administered vaginal
      progesterone in capsules 200 mg/3 times a day (Progeffik).

      The embryo transfer will be performed on day 5 of the embryo culture (Day +5). A biochemical
      pregnancy test beta- hCG and the P4 analysis will be performed 14 days after oocyte
      retrieval.

      All the cycles will be monitored according to the Department's standard criteria, using
      transvaginal ultrasound to assess embryonic development and endometrial thickness, as well as
      analytical controls.

      The study will be blinded to the investigator. The evaluating professionals will not know if
      the subject has been administered vaginal progesterone or subcutaneous progesterone. The
      medication will be delivered by a person who does not participate in the evaluations and who
      is dedicated to group assignment, to data centralisation, and to delivering the medication.

      The aim of this study is to determine if the ongoing pregnancy rate in patients undergoing a
      fresh embryo transfer cycle with donor oocytes is affected by the progesterone administration
      route.
    

Intervention name(s): subcutaneous progesterone; vaginal progesterone
Intervention type(s): Drug; Drug
Intervention description(s): subcutaneous progesterone 25 mg/day; vaginal progesterone in capsules 200 mg/3 times a day
Other intervention name(s): Protulex; Progeffik
Intervention MeSH terms: Progesterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Reproductive Techniques; Infertility; Reproductive Techniques Assisted
The Effect of Sildenafil Citrate on the Success Rate of Ovulation Induction Using Clomiphene
Condition: Anovulatory
MeSH terms: Anovulation
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of the study is to evaluate the effect of sildenafil citrate on the pregnancy rate in
      women undergoing induction of ovulation using clomiphene citrate.
    


Intervention name(s): Sildenafil & clomiphene citrate; clomiphene only
Intervention type(s): Drug; Drug
Intervention description(s): 105 Patients will receive 25 mg sildenafil citrate 6hourly orally (day 6 to the end of the cycle), and clomiphene citrate 100 mg/day (day 2 to 6) orally by the patient, for induction of ovulation; 105 Patients will receive clomiphene citrate 100 mg/day (day 2 to 6) orally by the patient, for induction of ovulation
Other intervention name(s): seldin and clomid; clomid
Intervention MeSH terms: Sildenafil Citrate; Clomiphene; Enclomiphene; Zuclomiphene
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Eltrombopag/Boceprevir and Eltrombopag/Telaprevir Drug-Drug Interaction Study In Healthy Adult Subjects
Condition: Thrombocytopaenia
MeSH terms: Thrombocytopenia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the current Phase I, open-label, three-period, single sequence, crossover
      study, TPL116010, is to evaluate the potential drug-drug interaction between eltrombopag
      (ELT) and bocrprevir (BCP) and between ELT and telaprevir (TLP) in healthy subjects. In this
      study there will be a screening visit, three treatment periods, and a follow-up visit. In
      Period 1, subjects will receive a single dose of ELT on Day 1, and pharmacokinetic (PK)
      sampling will occur for 72 hours. In Period 2, subjects will receive BCP/TLP for 10 days with
      PK sampling for 8 hours. In Period 3, subjects will receive a single dose of ELT with BCP/TLP
      on Day 1 only with PK sampling for 72 hours. Subjects will return for a follow-up visit
      within 10 to 14 days of the last dose of study drugs. The total duration of the study from
      Screening to Follow-up will be approximately 9 weeks.
    


Intervention name(s): Eltrombopag; Boceprevir; Telaprevir
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Each tablet contains 100 mg of Eltrombopag (Dose 200 mg); Each capsule contains 200 mg of Boceprevir (Dose 800 mg); Each tablet contains 375 mg of Telaprevir (Dose 750 mg)
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Drug interaction; INCIVEK (telaprevir),; SB-497115 (eltrombopag); Pharmacokinetics; Thrombocytopenia; VICTRELIS (boceprevir)
Effectiveness of Astym Treatment For de Quervain's Tenosynovitis
Condition: de Quervain's Disease
MeSH terms: Tenosynovitis; De Quervain Disease
Study type: Interventional

Summary: 
      To determine if the addition of Astym treatment to traditional therapy produces a more
      positive outcome then traditional therapy alone for the treatment of de Quervain's
      tenosynvitis. Two groups will be examined with one group receiving traditional therapy and
      the other group receiving traditional therapy in addition to Astym treatment protocol.
    


Intervention name(s): Occupational therapy; Occupational therapy with ASTYM
Intervention type(s): Other; Device
Intervention description(s): Occupational therapy for de Quervain's Tenosynovitis; Occupational therapy for de Quervain's Tenosynovitis plus ASTYM
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: de Quervain's disease; de Quervain's tenosynovitis.; ASTYM; de Quervain's treatment
Placebo Controlled Study of Preladenant in Participants With Moderate to Severe Parkinson's Disease (P07037)
Condition: Parkinson Disease; Idiopathic Parkinson Disease; Idiopathic Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a study of the efficacy and safety of preladenant in adult participants with moderate
      to severe Parkinson's Disease (PD). While on this study, participants will continue to take
      their usual, prescribed, stable regimen of levodopa (L-dopa) or L-dopa plus adjunct PD
      medications and will be randomized to receive 2 mg preladenant, 5 mg preladenant, or placebo,
      twice daily, for 12 weeks. After that, participants may choose to receive additional
      treatment with preladenant. The primary hypothesis is that at least the 5 mg twice daily dose
      of preladenant is superior to placebo as measured by the change from Baseline to Week 12 in
      the mean "off" time.
    


Intervention name(s): Preladenant; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Preladenant 2 mg or 5 mg oral tablet taken twice daily; Preladenant-matching placebo oral tablet taken twice daily
Other intervention name(s): SCH 420814; MK-3814
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Phase II Randomized Study of Cidofovir for Peripheral Cytomegalovirus Retinitis
Condition: Cytomegalovirus Retinitis; Acquired Immunodeficiency Syndrome
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections; Cytomegalovirus Retinitis; Retinitis; Immunologic Deficiency Syndromes
Study type: Interventional
Phase: Phase 2

Summary: 
      OBJECTIVES: I. Evaluate the safety and efficacy of intravenous cidofovir in patients with
      small peripheral cytomegalovirus retinitis.

      II. Obtain safety and efficacy data related to different dosages of cidofovir.
    

Detailed description: 
      PROTOCOL OUTLINE: This is a randomized study. Cidofovir is administered intravenously.
      Treatment ideally begins within 24 hours of randomization.

      In the first group, therapy is deferred until disease progression. Patients are then treated
      according to best medical judgement, which includes the option of cidofovir therapy.

      The second group receives induction with cidofovir every 7 days for 2 weeks, then begins
      maintenance with a low dose given every 14 days until dose-limiting toxicity or disease
      progression occurs.

      The third group receives the same cidofovir induction followed by a high maintenance dose
      given every 14 days until dose-limiting toxicity or disease progression occurs.

      Probenecid and intravenous hydration are administered concurrently with cidofovir.

      Patients are followed for progression and survival every 2 weeks for 23 weeks, then every 12
      weeks. At disease progression, patients may be re-treated with another course of induction
      and maintenance.
    

Intervention name(s): cidofovir
Intervention type(s): Drug
Intervention MeSH terms: Cidofovir
Primary purpose: Treatment
Keywords: cytomegalovirus retinitis; ophthalmologic disorders; rare disease
Safety and Protective Efficacy of IV Immunization With Cryopreserved PfSPZ Under A/P Chemoprophylaxis
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 1

Summary: 
      Single center, randomized, placebo-controlled, double-blinded trial using PfSPZ Challenge
      (NF54) under A/P chemoprophylaxis for immunization and PfSPZ Challenge (NF54) and PfSPZ
      Challenge (7G8) for repeat CHMI.

      A total of 30 adult, healthy, malaria naïve volunteers will receive three injections by
      Direct Venous Inoculation (DVI) of either placebo (n = 10), 51,200 PfSPZ Challenge (NF54) (n
      = 10), or 150,000 PfSPZ Challenge (NF54) (n = 10) under chemoprophylaxis with A/P at 4 week
      intervals. The placebo will be normal saline (0.9% NaCl).

      Ten weeks after the last dose of PfSPZ Challenge (NF54) for immunization, volunteers will
      undergo first CHMI and followed until asexual blood stage parasitemia, detected by
      quantitative real time PCR (qPCR) or thick blood smear microscopy. If parasitemic, they will
      be treated with A/P (used in this case as a standard treatment regimen). In the event of no
      parasitemia, volunteers will be followed until Day 28 post-CHMI and will not receive A/P.

      Sixteen to forty-four weeks after the last immunization, a second CHMI will be administered
      to assess longevity and cross-strain protection. All volunteers will be followed up to 28
      days post-inoculation. Those developing parasitemia will be treated with A/P.

      Volunteers of Group A will have CHMI with PfSPZ Challenge (NF54) followed by PfSPZ Challenge
      (7G8). Volunteers of Group B will have CHMI with PfSPZ Challenge (NF54) or PfSPZ Challenge
      (7G8) followed by PfSPZ Challenge (7G8). In the case that protective efficacy in Group A is
      ≥75% CHMI sequence will be 7G8-7G8. In the case that protective efficacy against homologous
      Challenge in Group A is <75%, volunteers will receive the same sequence as in Group A
      (NF54-7G8).
    


Intervention name(s): atovaquone/proguanil 250mg/100mg (A/P); PfSPZ Challenge (NF54); NaCl 0,9%
Intervention type(s): Drug; Biological; Other
Intervention description(s): Combination drug for chemo-prophylaxis or treatment of malaria; cryo-preserved Plasmodium falciparum sporozoites injected by venous inoculation; 0.9% NaCl solution for injection
Other intervention name(s): Malarone; Placebo
Intervention MeSH terms: Atovaquone; Proguanil; Atovaquone, proguanil drug combination
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Prospective Study to Evaluate Safety of Deb-TACE With 100µ Beads in Patients With Non Resectable HCC
Condition: Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Observational

Summary: 
      This is an observational, multicenter, single arm, prospective study to evaluate safety and
      tolerability of selective and ultraselective drug eluting beads transcatheter intraarterial
      chemoembolization (DEB-TACE) with up to 3 ml of well calibrated 100 µ microspheres and up to
      150 mg of doxorubicin, for the treatment of non resectable hepatocellular carcinoma (HCC).

      The hypothesis is that 100 µ beads penetrate deeper into the tumor than those eluting beads
      with larger volumes without increasing the risk and complications of DEB-TACE.
    

Detailed description: 
      In this observational, prospective study patients will undergo DEB-TACE and subsequent follow
      up procedures according to standard clinical practice. The primary aim of the study is to
      describe treatment safety and tolerability of 100 µ beads in DEB-TACE. As a secondary
      end-point a description of efficacy parameters will be obtained.
    

Intervention name(s): DEB-TACE
Intervention type(s): Device
Intervention description(s): Selective and ultraselective transcatheter intraarterial administration up to 3ml of well calibrated 100µ drug eluting microspheres with up to 150 mg of doxorubicin.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Target population includes:

          -  Patients with stage B HCC carcinoma according to Barcelona Clinic Liver Cancer
             classification (BCLC).

          -  Patients with stage A HCC according to BCLC if they are not candidates or not willing
             to go through surgery or radiofrecuency.
      
Keywords: Hepatocellular Carcinoma; TACE
Efficacy Study of Intravenous Iron Preparation to Iron Deficiency Anemia
Condition: Iron Deficiency Anemia
MeSH terms: Anemia; Anemia, Iron-Deficiency; Iron Deficiencies; Deficiency Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to confirm the non-inferiority of Z-213 compared to Saccharated
      Ferric Oxide using the maximum change in Hb from baseline over 12 weeks in patients with
      Iron-deficiency Anemia (IDA)
    


Intervention name(s): Z-213; Saccharated Ferric Oxide
Intervention type(s): Drug; Drug
Intervention description(s): The total iron dosage is calculated based on hemoglobin value and the patients' weight, IV on day 1, 8 and 15 (if needed); The total iron dosage is calculated based on hemoglobin value and the patients' weight, IV two or three times per week
Intervention MeSH terms: Ferric Oxide, Saccharated
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Change in Airway Responsiveness After Allergen Exposure
Condition: Allergic Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      Exposure to allergens changes the way the airway responds to some stimuli (methacholine). The
      investigators will look at whether or not exposure to allergens changes the way the airway
      responds to a different stimuli (mannitol) and compare that with the known stimuli
      (methacholine).
    


Intervention name(s): Mannitol; Methacholine Chloride
Intervention type(s): Drug; Drug
Intervention description(s): Indirect bronchoprovocation agent being compared to direct bronchoprovocation agent (methacholine); Direct bronchoprovocation agent being compared to indirect bronchoprovocation agent (mannitol)
Other intervention name(s): Aridol; Provocholine
Intervention MeSH terms: Mannitol; Methacholine Chloride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: asthma; allergies; mannitol; methacholine
ProSat - Long Term Effect of Probiotics on Satiety
Condition: Obesity; Appetite Regulation
Study type: Interventional

Summary: 
      The aim of the ProSat study is to examine the effects of a probiotic capsule containing Lb.
      Casei on subjective appetite sensation, ad libitum energy intake, and appetite hormone
      response in a single meal test and to determine whether the acute effects persist after daily
      supplementation of the probiotic capsule.
    


Intervention name(s): Probiotic
Intervention type(s): Dietary Supplement
Intervention description(s): Parallel, randomized, controlled 2 arms study.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
BI655130 (SPESOLIMAB) Induction Treatment in Patients With Moderate-to-severe Ulcerative Colitis
Condition: Colitis, Ulcerative
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This trial has two sequentially enrolling parts with different objectives. The primary
      objectives of this trial are

        -  to prove the concept of clinical activity of BI655130 (SPESOLIMAB) in patients with
           moderate-to-severely active ulcerative colitis who have failed previous biologic
           treatments and to identify efficacious and safe dose regimens in Part 1 (Phase II)

        -  to confirm efficacy and safety of BI655130 (SPESOLIMAB) in patients with
           moderate-to-severely active ulcerative colitis who have failed previous biologic
           treatments in Part 2 (Phase III)

        -  To provide, along with induction study 1368-0018 and the run-in cohort of 1368-0020, the
           target population to be evaluated in study 1368-0020.
    


Intervention name(s): Spesolimab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Solution for infusion; Solution for infusion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effective Treatment for Prescription Opioid Abuse
Condition: Prescription Opioid Dependence
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      There has been an alarming increase in abuse of prescription opioids in recent years. This
      project aims to develop an effective outpatient treatment for prescription opioid (PO) abuse
      that combines an intensive behavioral therapy with a pharmacotherapy regimen of buprenorphine
      detoxification and naltrexone maintenance.
    

Detailed description: 
      There has been an alarming increase in abuse of prescription opioids in recent years. This
      project aims to develop an effective outpatient treatment for prescription opioid (PO) abuse
      that combines an intensive behavioral therapy with a pharmacotherapy regimen of buprenorphine
      detoxification and naltrexone maintenance. Aim 1) Conduct a randomized, three-parallel-groups
      clinical trial (Study 1) to determine a buprenorphine dose-tapering schedule that prevents
      the poor retention and relapse that undermine many opioid detoxification regimens. Aim 2)
      Conduct a randomized, three-parallel-groups clinical trial (Study 2) to determine a duration
      of naltrexone therapy that sustains opioid abstinence following the buprenorphine
      detoxification.
    

Intervention name(s): buprenorphine taper followed by naltrexone maintenance; Behavioral therapy
Intervention type(s): Drug; Behavioral
Intervention description(s): direct comparison of 1-, 2- and 4-week durations of buprenorphine taper for treating prescription opioid abusers; those who successfully taper without resumption of illicit opioid use are subsequently transitioned to oral naltrexone therapy for the remainder of the 12-week trial; all participants receive a platform of intensive individual behavioral therapy and on-site urinalysis monitoring throughout the trial
Intervention MeSH terms: Naltrexone; Buprenorphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: prescription opioid; opioid detoxification; buprenorphine; naltrexone; community reinforcement approach; prescription opioid abuse