bioihbjkbjnl/mcl2 huggingface dataset:
Regulation of Stem Spermatogonia in the Mature Testis
Condition: Male Infertility
MeSH terms: Infertility; Infertility, Male
Study type: Observational

Summary: 
      Investigative trial to evaluate the role of a glial cell lined derived neurotrophic factor
      (GDNF) in regulation of spermatogonial renewal and testicular function. Goal of the trial is
      to provide greater information on the mechanisms that effect stem spermatogonial maintenance
      renewal and proliferation in its relation to male infertility.
    

Detailed description: 
      An essential requirement for sustaining male fertility is maintaining an adequate number of
      stem spermatogonia, the foundation of spermatogenesis. To achieve this, when the stem cells
      divide, some progeny must remain stem spermatogonia while other progeny differentiate. It is
      obvious that the correct balance between self-renewing replication and differentiation of
      stem spermatogonia is crucial to male fertility, and there is a indirect evidence that GDNF
      plays an important role in maintaining this balance in the normal mature testis. However,
      almost nothing is known about the in vivo regulation of this balance in the mature organ, of
      the specific function of GDNF in the adult testis, or if physiological changes in GDNF
      expression significantly affect the replication or differentiation of the stem cells. To
      address these critical issues, a unique mouse model that allows GDNF signaling to the stem
      spermatogonia to be specifically and reversibly inhibited in vivo by an ATP antagonist. With
      this model, the first direct evidence that GDNF is required for maintaining the stem
      spermatogonial pool in a normal mature testis. Additionally, the investigators have shown
      that when inhibition of GDNF signaling is reversed, the stem cells begin to rebuild the stem
      cell pool. Importantly, our data demonstrate that some stem spermatogonia are lost when GDNF
      signaling is inhibited for as little as 2 days, while other stem cells survive for up to 11
      days. This suggests that factors intrinsic or extrinsic to the stem cells modulate the
      response to GDNF. Using this new mouse model the mechanisms responsible for the loss of stem
      spermatogonia proliferation and regeneration will be investigated along with GDNF signaling
      and inhibition. At the end of all of this these studies will be done on waste tissue obtained
      from normal men and men with infertility who otherwise have testicular surgery for
      therapeutic purposes.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy males undergoing testicular biopsy by any urologic surgeon at Weill Cornell
        Medicine.
      
Biospecimen description: 
      Testicular tissue, Blood
    
Keywords: Male Infertility; Spermatogonial stem cell
An Multi-site Prospective Study to Assess the Efficacy and Safety of MMF in the Treatment of Proliferative IgA Nephropathy(IgAN)
Condition: IgA Nephropathy (IgAN)
MeSH terms: Kidney Diseases; Glomerulonephritis, IGA
Study type: Interventional

Summary: 
      In order to treat proliferative IgA Nephropathy(IgAN), The investigators designed an open,
      prospective, randomized parallel study to access the efficacy and safety of MMF compared to
      corticosteroid .

      Patients who fulfill the inclusion criteria will be randomized in a 1:1 ratio to either the
      MMF group or corticosteroid group.
    

Detailed description: 
      To access the efficacy and safety of MMF compared to corticosteroid in in treatment of
      proliferative IgA Nephropathy(IgAN).
    

Intervention name(s): mycophenolate mofetil plus lower dose of Prednisone; Prednisone in full dose
Intervention type(s): Drug; Drug
Intervention description(s): MMF 1.0-1.5g/d*6mons Prednisone 0.4-0.6 mg/kg/d; 0.8-1mg/kg/d
Other intervention name(s): MMF
Intervention MeSH terms: Mycophenolic Acid; Prednisone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: MMF treatment IgA Nephropathy (IgAN)
Effectiveness Study of Videoconferencing on Teaching Parent Training Skills to Parents of Children With Attention Deficit Hyperactivity Disorder (ADHD)
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effectiveness of group parent training taught
      through videoconferencing on ADHD treatment via a comparison between participants using
      traditional face-to-face parent training sessions and a group using teleconferencing.
    

Detailed description: 
      Subjects with a primary diagnosis of ADHD between the ages of 6 and 14 years were enrolled.
      All subjects were screened and assessed for psychiatric and learning disorders using
      structured interviews (DICA, parent and child version, Reich et al, 2000) based on DSM IV
      criteria and parent and teacher rating scales. Mothers took the Beck Depression Inventory
      (BDI) to assess for depression.

      Parents or primary caregivers were randomized to two treatment arms (videoconference or face
      to face). Ten sessions of weekly parent training through either videoconference or
      face-to-face delivery was conducted using Dr. Russell A. Barkley's manual. A non-mandatory
      skill training and play group was offered to the children of both groups while parents
      attended the parent training group in order to provide child care for the parents during the
      training sessions.

      Following outcomes will be measured to assess the effectiveness of the intervention:

      Primary outcome Acceptance of the parent and children on the mode the communication as well
      as parent training.

      Secondary outcomes:

        1. Parent-child relations measured by the Parent Child Relationship Questionnaire (PCQ)

        2. The Vanderbilt Assessment Scale (parent & teacher versions), Children Global Assessment
           Scale (CGAS), Clinical Global Impression- Severity score (CGI-S), and Clinical Global
           Impression-Improvement Scores (CGI-I) assessed the severity of core symptoms of ADHD and
           oppositional/aggressive symptoms.

        3. The parent and teacher-rated versions of the Social Skills Rating System (SSRS) assessed
           social skills.
    

Intervention name(s): parent training
Intervention type(s): Behavioral
Intervention description(s): Behavioral management skill training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ADHD; Parent training; Videoconference
Efficacy of Socket Grafting for Alveolar Ridge Preservation
Condition: Atrophy of Edentulous Alveolar Ridge
MeSH terms: Atrophy
Study type: Interventional

Summary: 
      The purpose of this study is to clinically and radiographically assess whether the use of a
      ridge preservation technique significantly minimizes alveolar ridge resorption following
      tooth extraction.
    

Detailed description: 
      Subjects requiring single-rooted tooth extractions and future tooth replacement therapy with
      implant-supported restorations will be recruited. Subjects will be randomly assigned to
      either a control (tooth extraction alone) or an experimental group (tooth extraction and
      ridge preservation using an allograft to fill the alveolar socket covered with a
      non-absorbable, dense polytetrafluoroethylene membrane [dPTFE]). Clinical linear measurements
      of the ridge (horizontal and vertical) will be obtained using a tooth-supported stent.
      Following extraction, primary closure of the socket will not be attempted. Subjects will be
      re-evaluated at 1 and 4 weeks. Implant placement surgery will be performed at 16 weeks.
      Clinical measurements will be repeated upon surgical re-entry. Cone beam computed tomographic
      (CBCT) scans will be obtained at baseline (after tooth extraction) and at 14 weeks (prior to
      implant placement) to assess alveolar ridge volumetric changes (primary outcome). Secondary
      outcome measures include changes in bucco-lingual and apico-coronal clinical measurements of
      the ridge and changes in modified wound healing index changes overtime. The influence of the
      thickness of the facial and lingual bone of the alveolar ridge and the width of the
      keratinized tissue on the remodeling of the ridge will be evaluated.
    

Intervention name(s): Tooth extraction and grafting with allograft; Tooth extraction
Intervention type(s): Procedure; Procedure
Intervention description(s): Alveolar ridge preservation using a bone grafting material (allograft) and a synthetic dPTFE (dense Polytetrafluoroethylene) barrier membrane; Minimally traumatic single-rooted tooth extraction
Other intervention name(s): Alveolar socket grafting
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Safety of Pediatric COVID-19 Vaccination
Condition: Pain; Injection Site Reaction; Adverse Drug Event
MeSH terms: COVID-19; Injection Site Reaction; Drug-Related Side Effects and Adverse Reactions
Study type: Observational

Summary: 
      This is a prospective, observational study. During the study, children and adolescents (ages
      ≥ 5 to < 16) will be followed post administration of mRNA COVID-19 vaccines.

      Injection site (local), systemic reaction, and unsolicited adverse event data will be
      assessed on vaccination day and during the 7 days following each vaccination using either
      identical web-based or paper diaries, depending on study participant preference.

      At Duke University, Cincinnati's Children Hospital, and Kaiser Permanente Northern
      California, serum samples will be collected for optional assessment of antibody titers to
      COVID-19. Each participant who opts in will have baseline (within 3 days of vaccination)
      serologies obtained and immunogenicity assessment at 28 (+7) days after each dose.

      All participants will be followed for 180 days after dose 2 for serious adverse events and
      adverse events of special interest.
    


Intervention name(s): Observational
Intervention type(s): Other
Intervention description(s): Observational
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        320 healthy male or female ≥ 5 years to < 16 years of age
      
Biospecimen description: 
      Serum
    
Keywords: COVID-19 vaccine; fever following vaccination; pain following vaccination
A Phase I Study of IDP-73152 Mesylate in Health Male Volunteer
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      A dose block-randomized, double-blinded, placebo-controlled, single dose, dose-escalation
      clinical phase I study to evaluate the safety, pharmacokinetics and food effect of IDP-73152
      mesylate after oral administration in healthy male volunteer
    


Intervention name(s): IDP-73152 mesylate 40 mg; IDP-73152 mesylate 80 mg; IDP-73152 mesylate 160 mg; IDP-73152 mesylate 320 mg; IDP-73152 mesylate 640 mg; IDP-73152 mesylate 1280 mg; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): IDP-73152 mesylate 40 mg single dose administration; IDP-73152 mesylate 80 mg single dose administration; IDP-73152 mesylate 160 mg single dose administration; IDP-73152 mesylate 320 mg single dose administration; IDP-73152 mesylate 640 mg single dose administration; IDP-73152 mesylate 1280 mg single dose administration; Placebo single dose administration
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: male; Phase I; A dose block-randomized; Double-blinded; Placebo controlled; Single Dose; dose Escalation; IDP-73152 mesylate; Food Effect; Pharmacokinetics; health male volunteer; PDF inhibitor
Study to Evaluate the Efficacy and Safety of Filgotinib in the Treatment of Small Bowel Crohn's Disease (SBCD)
Condition: Small Bowel Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to evaluate the efficacy of filgotinib, when compared
      to placebo, in establishing clinical remission defined as Crohn's disease activity index
      (CDAI) < 150, at Week 24 in participants with small bowel Crohn's disease (CD). Participants
      will have the option to enter a separate long-term extension study if they meet eligibility
      requirements.
    


Intervention name(s): Filgotinib; Placebo to match filgotinib
Intervention type(s): Drug; Drug
Intervention description(s): Tablet(s) administered orally once daily; Tablet(s) administered orally once daily
Other intervention name(s): GS-6034; GLPG0634
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Osteoporosis Prevention With Low Dose Alendronate
Condition: Osteopenia
MeSH terms: Bone Diseases, Metabolic
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy of the intermittent administration of
      alendronate in a low dose, 70 mg once every two week, as osteoporosis prevention for
      menopausal, osteopenic patients, who don't want or can't receive an oestrogenic substitution
      treatment.
    


Intervention name(s): alendronate; Calcium/Vitamin D; placebo
Intervention type(s): Drug; Dietary Supplement; Drug
Intervention description(s): alendronate 70 mg every 2 weeks; Calcium 500 mg and vitamin D supplementation according to serum level; identical placebo every 2 weeks
Intervention MeSH terms: Vitamin D; Alendronate; Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: osteopenia; osteoporosis prevention; alendronate
Phenylephrine Pediatric Pharmacokinetic Study
Condition: Rhinitis
MeSH terms: Rhinitis
Study type: Interventional
Phase: Phase 1

Summary: 
      To characterize the pharmacokinetics of phenylephrine in two pediatric populations: children,
      ages 2 to <12 years, and adolescents, ages 12 to <18 years.
    

Detailed description: 
      This study has an open-label, single-dose classical pharmacokinetic design with no comparator
      treatment or group. At least twenty-four (24) children, ages 2 to <12 years, and twelve (12)
      adolescents, ages 12 to <18 years, with nasal symptoms due to hay fever or other upper
      respiratory allergies will complete the study. To ensure that younger children are
      represented, at least 35% (8) of the 24 children enrolled will range from 2 to <6 years of
      age.
    

Intervention name(s): phenylephrine HCl
Intervention type(s): Drug
Intervention description(s): A single dose of a liquid dosage form of phenylephrine HCl 2.5mg/5mL, using a weight-age dosing schedule
Other intervention name(s): Children's Sudafed PE Nasal Decongestant Liquid
Intervention MeSH terms: Phenylephrine; Oxymetazoline; Nasal Decongestants
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Phase I Mass Balance Study of [14C]GP681 in Healthy Chinese Male Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a single-center, open-label, and single-dose clinical study to evaluate the
      mass balance, biotransformation and pharmacokinetics of [14C]GP681 in healthy Chinese male
      volunteers, revealing the overall pharmacokinetic characteristics of GP681 in humans, and
      providing a reference for the rational administration.
    


Intervention name(s): [14C] GP681
Intervention type(s): Drug
Intervention description(s): 40 mg suspension containing 100μCi of [14C]GP681
Intervention model: Single Group Assignment
Intervention model description: Open-label, radiolabeled, single-dose study of an oral solution of [14C]GP681(40mg/100μCi) in 6 healthy male volunteer.
Masking: None (Open Label)
Primary purpose: Other
The Effects of Resveratrol and Acute Exercise on Endothelial Function in Postmenopausal Women
Condition: Endothelial Dysfunction
Study type: Interventional

Summary: 
      This pilot study plans to learn more about the aging of blood vessels and arteries in women.
      As women age and go through menopause, their risk for cardiovascular disease increases. Also
      with aging and menopause, levels of the reproductive hormone estradiol decline. Hormone
      replacement therapy to restore estradiol levels does not protect women from cardiovascular
      disease, so lifestyle changes, such as regular exercise, are recommended to reduce disease
      risk. However, there are differences between men and women in their response to exercise. In
      older men, exercise improves the health of their arteries, but in postmenopausal women,
      exercise does not provide this benefit. The purpose of this pilot study is to determine
      whether low estradiol levels in postmenopausal women are responsible for the poor vascular
      response to exercise. In this study the investigators will also test whether treatment with
      resveratrol, a plant compound found in red wine, improves postmenopausal women's response to
      exercise. The investigators hypothesize that acute treatment with estrogen or resveratrol
      will improve vascular responses to an acute bout of exercise.
    


Intervention name(s): Climara; Placebo patch; Resveratrol; Placebo
Intervention type(s): Drug; Drug; Dietary Supplement; Dietary Supplement
Intervention description(s): Placebo patch designed to match active Climara patches.; Placebo tablets designed to match active resveratrol tablets.
Other intervention name(s): Estradiol transdermal patch
Intervention MeSH terms: Resveratrol; Estradiol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Lacritin and Heparanase Levels in Human Tears After Laser Refractive Surgery
Condition: Myopia
MeSH terms: Myopia
Study type: Observational

Summary: 
      The purpose of this study is to measure tear lacritin and heparanase levels before and
      following surgery using a minimal risk procedure to collect tears from patients undergoing
      PRK or LASIK.
    

Detailed description: 
      Lacritin is a naturally occurring tear protein with antimicrobial activity that is capable of
      stimulating mitogenesis in human corneal epithelial cells and promoting production of tears
      in lacrimal gland acinar cells. A recently developed immunoassay for lacritin may help
      characterize the lacritin response following refractive surgery with the possible development
      of recombinant lacritin as a novel therapeutic agent for wound healing. Heparanase (HPSE)
      acts as a regulator for lacritin by cleaving heparan sulfate chains and allowing lacritin to
      bind. We aim to measure both tear lacritin and HPSE pre- and post-operatively to elucidate
      lacritin and HPSE's response in patients undergoing PRK (photorefractive keratectomy) and
      LASIK (Laser-assisted in situ keratomileusis) at the Walter Reed Center for Refractive
      Surgery.
    

Intervention name(s): Tear collection
Intervention type(s): Other
Intervention description(s): Tear collection
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Active duty military aged 21 to 55 with myopia up to -10.00 diopters eligible for care at
        Walter Reed Army Medical Center.
      
Keywords: Myopia; refractive surgery; LASIK; PRK; Lacritin; Heparanase
Bioresorbable Vascular Scaffold in Patients With Myocardial Infarction
Condition: ST Elevation Acute Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 4

Summary: 
      Evaluation of the feasibility and safety of Bioresorbable Vascular Scaffold (BVS) in patient
      treated with primary PCI (pPCI).
    

Detailed description: 
      Background. Drug-eluting stent (DES) implantation may offer benefits in terms of repeat
      revascularization in patients with ST elevation myocardial infarction (STEMI). The everolimus
      eluting bioresorbable vascular scaffold (BVS) has shown efficacy and safety in stable patient
      but not in acute coronary syndromes. The study tested the feasibility and safety of BVS in
      patient treated with primary PCI (pPCI) Methods. Consecutive STEMI patients admitted within
      12 hours of symptom onset and undergoing primary angioplasty and stent implantation at a
      tertiary center with 24-hour primary PCI capability will be randomly assigned to everolimus
      eluting stent (EES) or BVS. Primary endpoints are procedural and clinical success. The MACE
      (cardiac death, non fatal myocardial infarction, target lesion revascularization (TLR)) and
      definite or probable ST will be evaluated at six months.
    

Intervention name(s): Bioresorbable vascular scaffold; Everolimus eluting stent
Intervention type(s): Device; Device
Intervention description(s): stenting of an acute thrombotic lesion in patient within STEMI; stenting of an acute thrombotic lesion in patient within STEMI
Other intervention name(s): BVS, ABSORB (Abbot Vascular); Xience Prime (Abbott Vascular)
Intervention MeSH terms: Everolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: myocardial infarction; primary PCI; stent