bioihbjkbjnl/mcl2 huggingface dataset:
Safety, Tolerability, PK and PD of Posiphen® in Subjects With Early Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study evaluates the safety and pharmacological effects of 3 different doses of Posiphen®
      when compared to a placebo, in adult male and female patients with early Alzheimer's disease
      (AD).
    

Detailed description: 
      Posiphen®, which was discovered by the US National Institute on Aging (NIA) is a small,
      orally active, experimental drug that specifically inhibits the synthesis of amyloid
      precursor protein (APP), Tau and α-Synuclein. It is distinct from other Alzheimer's disease
      drugs currently in development, because it inhibits the formation of several toxic proteins,
      rather than removing individual toxic protein after they are produced. Posiphen has potential
      utility as a disease modifying treatment for AD. The present study will confirm the
      pharmacokinetics (PK) of Posiphen and its metabolites in plasma and cerebral spinal fluid
      (CSF). It will also measure the effects of a 23-25 day treatment period with Posiphen on the
      CSF and plasma levels of a number of biomarkers, inflammatory factors and control proteins.
      It will also expand the safety data in humans by extending the treatment period from 10 days
      to a treatment period from 23-25 days. In addition, this study will measure concentrations of
      various soluble biomarkers in CSF and use the SILK™ assay methods to directly measure the
      effect of Posiphen on the fractional synthesis rate of Aβ40 in CSF, which will help guide the
      further development of Posiphen and determine the feasibility of SILK™ in a multicenter
      trial.
    

Intervention name(s): Posiphen; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): oral solid dosage form capsule; oral solid dosage form capsule
Intervention MeSH terms: Phenserine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Alzheimer's Disease; SILK™; Pharmacodynamics; Safety; Pharmacokinetics
Hepatitis B Virus Mutants and the Therapeutic Effect of Peginterferon Alfa-2a in HBeAg-Positive Chronic Hepatitis B
Condition: Hepatitis B, Chronic
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Observational

Summary: 
      In order to clarify the association between HBV mutations appearing before and during
      interferon therapy and the therapeutic effects, serial serum samples from 100 HBeAg-positive
      CHB patients undergoing peginterferon alfa-2a therapy will be collected and analyzed for the
      mutations of preS/S gene and BCP-preC/C region, particularly for the deletion mutations.
      Furthermore, Real-Time PCR will be performed to measure the ratios of wild-type HBV and
      deletion mutant HBV before and at the end of peginterferon alfa-2a therapy. Finally,
      statistical analysis will be done to elucidate whether the mutations of preS/S gene and
      BCP-preC/C region have any relation with the therapeutic effect of peginterferon alfa-2a.
    

Detailed description: 
      Hepatitis B virus (HBV) infection is a serious worldwide health issue. Approximately 400
      million people worldwide are chronic hepatitis B (CHB) patients. Currently, two therapeutic
      methods can be used to treat CHB. One is the nucleos(t)ide analogues, the other is the
      interferon alfa. Interferon alfa acts mainly by enhancing the immune system and directly
      inhibits the virus to a limited extent. It is known that mutations at preS, S, basal core
      promoter, precore and core gene are associated with an increased risk of HCC. However, it
      remains to be clarified as to the relation between HBV mutations and the therapeutic
      responses to interferon treatment. In order to clarify the association between HBV mutations
      appearing before and during interferon therapy and the therapeutic effects, serial serum
      samples from 100 HBeAg-positive CHB patients undergoing peginterferon alfa-2a therapy will be
      collected and analyzed for the mutations of preS/S gene and BCP-preC/C region, particularly
      for the deletion mutations. Furthermore, Real-Time PCR will be performed to measure the
      ratios of wild-type HBV and deletion mutant HBV before and at the end of peginterferon
      alfa-2a therapy. Finally, statistical analysis will be done to elucidate whether the
      mutations of preS/S gene and BCP-preC/C region have any relation with the therapeutic effect
      of peginterferon alfa-2a.
    

Intervention name(s): Peginterferon alfa-2a
Intervention type(s): Drug
Intervention description(s): Peginterferon alfa-2a at 180 ug weekly for 24 weeks
Other intervention name(s): Pegasys
Intervention MeSH terms: Peginterferon alfa-2a
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        HBeAg-positive chronic hepatitis B
      
Biospecimen description: 
      Serum specimens
    
Keywords: Chronic hepatitis B; Peginterferon alfa-2a
Oral Ghrelin Agonist in Healthy Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      EP01572 is a peptidomimetic growth hormone secretagogue, which has potent GH-releasing
      activity after intravenous administration.It is an analogue of the natural compound ghrelin.
      Since an oral delivery system would be preferable in many of the possible therapeutic
      indications, the pharmacological profile and the GH-releasing activity of increasing single,
      oral doses of EP01572 in healthy volunteers will be evaluated. In addition, the
      pharmacokinetics and pharmacological effects of EP01572 will be investigated after
      intraduodenal administration.
    

Detailed description: 
      EP01572 willbe given orally to 36 male subjects; the treatment will consist of one oral dose
      of either EP01572 or placebo (0.005, 0.05 and 0.5 mg/kg body weight). Subjects will receive
      one dose of EP01572 and placebo. Six subjects will receive two additional oral doses of
      EP01572: 0.125 and 0.25 mg/kg body weight. In another part, 6 subjects will receive the
      following treatments in a randomized order: 1) administration of a bolus of saline (placebo)
      to the small intestine; 2) intraduodenal (ID) administration of a bolus of EP01572 at 0.2
      mg/kg body weight; 3) ID perfusion of a bolus of EP01572 at 0.35 mg/kg body weight; 4) ID
      perfusion of a bolus of EP01572 at 0.5 mg/kg body weight.
    

Intervention name(s): EP1572 (ghrelin agonist) oral and duodenal application
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: GH release; Pharmacokinetics; Safety
The Effect of Long-Acting Mesalamine on Post-Infective Irritable Bowel Syndrome- A Pilot Study
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the effects of long acting mesalamine (Lialda) in
      patients with Post-Infective Irritable Bowel Syndrome (PI-IBS). The investigators will
      evaluate gastrointestinal symptoms, IBS specific quality of life (IBS-QOL), and plasma
      cytokines before and after treatment with Lialda.
    

Detailed description: 
      This study will test long acting mesalamine in the management of PI-IBS. It has the potential
      to improve QOL and perhaps gastrointestinal symptoms, in patients with PI-IBS. The results of
      this study, if positive, will provide preliminary data for a large scale clinical trial.

      This study will also provide information about plasma cytokines in patients with PI-IBS and
      whether improvement in symptoms correlates with improvement in plasma cytokines.
    

Intervention name(s): Mesalamine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 2 1.2g tablets once daily for 8 weeks. Patients randomized 50/50 to either Mesalamine or the Placebo; This is an inactive pill
Other intervention name(s): Lialda; Inactive drug
Intervention MeSH terms: Mesalamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Irritable Bowel Syndrome; Diarrhea; Mesalamine; Gastroenteritis; abdominal pain; hypersensitivity
A Research Study of How NNC0174-0833 Taken With Semaglutide Works in People Who Are Overweight or Obese
Condition: Obesity; Overweight
MeSH terms: Obesity; Overweight
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of this study is to find out how NNC0174-0833 taken with semaglutide works in people
      who are overweight or obese. Both study medicines have been investigated on their own. The
      study also looks at how the study medicines behave in participant's body and how they are
      removed from the participant's body. Participants will get 1 of the following 2 treatments -
      which treatment any participant gets is decided by chance: Semaglutide (a new medicine) and
      NNC0174-0833 (a potential new medicine), or semaglutide and placebo (a "dummy medicine
      similar to the study medicine but without active ingredients). Participants will get 2
      injections per week for 20 weeks. A study nurse at the clinic will inject the medicine with a
      needle in a skin fold in the participant's stomach area. The study will last for about 16
      months, but duration of participation for any participant will last up to about 7.5 months.
      Participants will have 28 clinic visits with the study staff and some will be overnight
      visits. Participants will be asked about their health, medical history and habits including
      mental health questionnaires.
    


Intervention name(s): NNC0174-0833; Semaglutide; Placebo (NNC0174-0833)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Participants will receive increasing dose levels of 0.16 mg, 0.3 mg, 0.6 mg, 1.2 mg, 2.4 mg or 4.5 mg of NNC0174-0833 (subcutaneous [s.c.], in a lifted fold of the abdominal skin) injection once weekly starting with a very low dose and then escalated every 4 weeks to a slightly higher dose each time. Each participant will only be given one dose level.; Participants will receive 2.4 mg of semaglutide (s.c., in a lifted fold of the abdominal skin) injection once weekly starting with a very low dose and then escalated every 4 weeks to a slightly higher dose each time.; Participants will receive once weekly injections of NNC0174-0833 matched placebo.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Role of Hydrosalpinx in Recurrent Miscarriage
Condition: Abortion, Spontaneous; Miscarriage, Recurrent; Hydrosalpinx
MeSH terms: Abortion, Spontaneous; Abortion, Habitual; Recurrence
Study type: Observational

Summary: 
      Miscarriage affects one in five pregnancies and little progress has been made in
      understanding and treating this distressing condition. C. trachomatis is the most common
      sexually transmitted infection in the UK. C. trachomatis infection can have serious health
      consequences, including fallopian tube damage. Untreated C. trachomatis infection and tubal
      damage have been associated with miscarriage and adverse pregnancy outcomes such as preterm
      birth, low birth weight and stillbirth. A cohort study is needed to establish the prevalence
      of tubal disease in women with recurrent miscarriages. HyCoSy will be performed to identify
      tubal disease and establish the magnitude of the problem in the recurrent miscarriage
      population. The prognosis of tubal disease on miscarriage and other obstetric outcomes, and
      the role of medical interventions such as tubal surgery (to treat hydrosalpinx) on reducing
      miscarriage and adverse obstetric outcomes will also be studied.

      Objectives

        1. Establish the prevalence of hydrosalpinx in the recurrent miscarriage population.

        2. Establish the prognosis of women diagnosed with recurrent miscarriage with concurrent
           hydrosalpinx.

        3. Explore the role of tubal surgery for improving reproductive outcomes in women with
           recurrent miscarriage population and hydrosalpinx.
    


Intervention name(s): Hysterosalpingo-contrast-sonogram
Intervention type(s): Diagnostic Test
Intervention description(s): A contrast ultrasound scan to examine fallopian tube pathology and blockage
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women who have suffered from 2 or more pregnancy losses
Pharmacoscintigraphic Study to Evaluate Two Sildenafil Products
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will assess a new biphasic release sildenafil formulation (N4S001), developed by N4
      Pharma. The N4S001 tablet contains a total of 100 mg sildenafil.

      The N4S001 tablet is designed to provide a faster onset of release and a longer therapeutic
      window compared to currently marketed sildenafil products.

      This is a single centre, open-label, four-arm crossover study in up to 12 healthy male
      volunteers.

      The following treatments will be dosed:

      Assessment Visit 1: N4S001 tablet containing 100 mg sildenafil (fasted)

      Assessment Visit 2: N4S001 tablet containing 100 mg sildenafil (fed)

      Assessment Visit 3: Viagra film-coated tablet containing 50 mg sildenafil (fasted)

      Assessment Visit 4: Viagra film-coated tablet containing 50 mg sildenafil (fed)

      The immediate release layer of each N4S001 tablet will be radiolabelled to contain 4 MBq
      (megabecquerel) 99mTc at time of dose.
    

Detailed description: 
      A pharmacoscintigraphic clinical study will be undertaken to quantify the scintigraphic
      kinetics and extent of dispersion of the immediate release portion of the N4S001 tablet in
      the oral cavity, and to measure sildenafil and its main metabolite, N-desmethyl sildenafil,
      in the blood plasma. The study will comprise an open-label, four-treatment crossover study in
      up to 12 healthy male volunteers. All subjects will receive four treatments throughout the
      study. The initial fast onset release portion of each N4S001 tablet will be radiolabelled to
      enable the dispersion characteristics of this part of the formulation to be investigated
      in-vivo. The immediate release portion of the N4S001 tablet will be radiolabelled to contain
      approximately 4 MBq technetium-99m (99mTc) at time of dose (TOD). Blood samples will be taken
      at pre-defined times to allow pharmacokinetic (PK) evaluation of drug absorption of the
      N4S001 tablet and of the reference product, Viagra 50 mg film coated tablets. Blood pressure
      will be recorded at set time intervals to assess the effects of the N4S001 tablet against the
      reference product. Subjects will also assess the taste acceptability of the N4S001 tablet
      using a 7-point categorical scale and oral examinations will be completed to assess any local
      oral effects of N4S001.
    

Intervention name(s): Sublingual sildenafil; Oral sildenafil
Intervention type(s): Drug; Drug
Intervention description(s): 100 mg biphasic sildenafil tablet; 50 mg oral sildenafil (Viagra)
Other intervention name(s): N4S001; Viagra
Intervention MeSH terms: Sildenafil Citrate
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
ARTEMIS Peanut Allergy In Children
Condition: Peanut Allergy
MeSH terms: Hypersensitivity; Peanut Hypersensitivity
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to demonstrate the efficacy and safety of AR101 through oral
      immunotherapy (OIT) in peanut-allergic children.
    

Detailed description: 
      This is a European, multicenter, double-blind, randomized, placebo-controlled 2-arm study of
      the efficacy and safety of AR101 in peanut-allergic children.
    

Intervention name(s): AR101 powder provided in capsules & sachets; Placebo powder provided in capsules & sachets
Intervention type(s): Biological; Other
Intervention description(s): Study product formulated to contain peanut protein at different dosage strengths for use as defined in the protocol; Study product formulated to contain only inactive ingredients for use as defined in the protocol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: AR101; Characterized Peanut Allergen; CPNA (Characterized Peanut Allergen); OIT (oral immunotherapy); Peanut Allergy; Peanut-Allergic Children; Desensitization; ARTEMIS; Allergy
HSCT For Patients With High Risk Hemoglobinopathies Using Reduced Intensity
Condition: Sickle Cell Disease; Beta Thalassemia-Major
MeSH terms: Anemia, Sickle Cell; Thalassemia; beta-Thalassemia; Hemoglobinopathies
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study will evaluate the use of reduced intensity conditioning regimen in patients with
      high risk hemoglobinopathy Sickle Cell and B-Thalassemia Major in combination with standard
      immunosuppressive medications, followed by a routine stem cell transplant in order to assess
      whether or not it is as effective as myeloablative high dose chemotherapy and transplant.
    

Detailed description: 
      Standard myeloablative regimens are toxic to non-hematopoietic tissue and are associated with
      treatment related mortality and morbidity (TRM). Preparative regimens that are not
      myeloablative are associated with a greatly decreased incidence of TRM. In addition to
      providing a less toxic regimen, the reduced intensity chemotherapy preparative regimen also
      remains immunosuppressive enough to allow donor engraftment. Recent report of
      non-myeloablative regimens which resulted in engraftment of allogeneic stem cell in
      hematological malignancies raises the possibility that this conditioning regimen might be
      useful in achieving engraftment in non hematological disorder.

      In an effort to achieve stable engraftment with any suitable donor stem cell source and to
      minimize toxicity the investigators have developed a new reduced intensity conditioning
      regimen for high risk hemoglobinopathies with the main aim of significantly suppressing the
      recipient's immune system and facilitate engraftment.

      Non-myeloablative or reduced-intensity immunosuppressive preparative regimens have achieved a
      stable, mixed chimerism engraftment and successful allogeneic bone marrow transplants.
    

Intervention name(s): alemtuzumab (Campath IH); Fludarabine; Melphalan; Cyclosporine; Mycophenolate mofetil; Tacrolimus; Hematopoietic Stem Cell Transplantation
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Biological
Intervention description(s): Alemtuzumab (Campath IH) is given daily over first 4 days, Day -20 to Day -17; Fludarabine 35/m2 is given daily over 4 days on Day -7 to Day -4.; Melphalan 70mg/m2 is given daily over 2 days on Day -3 to Day -2.; Immunosuppressant to prevent graft vs host disease is given on Day -1 prior to stem cell infusion; Immunosuppressant to prevent graft vs host disease is given on Day -1.; Immunosuppressant to prevent graft vs host disease is given Day -1 prior to stem cell infusion; Human Leukocyte Antigen (HLA) matched or mismatched; related or unrelated hematopoietic stem cells to be transplanted on Day 0.
Other intervention name(s): Campath-IH
Intervention MeSH terms: Cyclosporine; Mycophenolic Acid; Fludarabine; Melphalan; Alemtuzumab; Tacrolimus; Cyclosporins
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Reduced Intensity Conditioning Regimen
Effects of Surgery Start Time on Postoperative Interleukin-6, Interleukin-8, and Cortisol
Condition: Hemiarthroplasty; Arthroplasty, Replacement, Hip
Study type: Interventional

Summary: 
      Cortisol is a hormone that increases after trauma or surgery and has circadian rhythm. It has
      a form that is increased in the morning and decreased in the evening. The investigators
      expected to be influenced by circadian rhythm according to the time of operation, and
      compared morning and afternoon surgery.
    

Detailed description: 
      44 patients to undergo hip hemiarthroplasty or total hip replacement were divided to morning
      surgery group(Group A) and afternoon surgery group(Group P). All surgery was done by the same
      orthopedic surgeon. Anesthesia of Group A was started at 8 a.m. and Group P was at 12~2 p.m.
      Blood sampling was performed at 7:30 a.m., after induction of anesthesia, 6, 12, 24 and 48
      hours after surgery in all patients of both groups. Cortisol, IL-6, and IL-8 was measured
      immediately after blood sampling. Visual analogue scale(VAS) was used to assess the degree of
      pain at before start of anesthesia, 6, 12, 24 and 48 hours after surgery. The postoperative
      hospital stay was calculated. Postoperative management was done by the same management team.
      Surgical wounds were treated at the same 24 hour intervals.

      A sample size was calculated to differentiate between groups. Because difference of cortisol
      according to groups in ANOVA based on pilot study, the sample size was 20 patients per group.
      (Effect size f(v)= 0.5297047, α=0.05, 1-β=0.90) The investigators recruited total 44 patients
      to cover dropout 10%.
    

Intervention name(s): Total hip replacement; Hemi-arthroplasty
Intervention type(s): Procedure; Procedure
Intervention description(s): Total hip replacement starts in the morning in group A and starts in the afternoon in group P.; Hemi-arthroplasty starts in the morning in group A and starts in the afternoon in group P.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients receiving total hip replacement or hip hemiarthroplasty are divided into two groups: the morning surgery group and the afternoon surgery group. After surgery, cortisol, IL-6, IL-8 and VAS were measured and compared.
Masking: None (Open Label)
Primary purpose: Treatment