bioihbjkbjnl/mcl2 huggingface dataset:
Speed of Premolar Extraction Space Closure: Healed vs Recent Extraction Site
Condition: Orthodontic Appliance
Study type: Interventional

Summary: 
      The aim was to compare the rate of teeth movement into fresh and old extraction sites.
    

Detailed description: 
      Trial design: Randomized controlled clinical trial with a split mouth design. Setting: Jordan
      University of Science and Technology(JUST) Postgraduate Dental Teaching Clinics and labs.

      Participants and interventions: Twenty-eight subjects with bimaxillary proclination requiring
      extraction of all first premolar teeth participated in this study. In the lower arch, two
      groups were also identified; group 1 having the first premolar extracted before the
      commencement of orthodontic treatment and group 2 having the first premolar extracted just
      before space closure when 0.019 x 0.025 inch SS archwire was reached. Patients were
      followed-up monthly for three months. At every follow-up visit lower alginate impressions
      were taken. Extraction spaces in the lower arch follow-up models were measured using digital
      caliper.

      The rate of extraction space closure in the lower arch was assessed monthly.
    

Intervention name(s): Space closure into old extraction space; Space closure into recent extraction space
Intervention type(s): Device; Device
Intervention description(s): Lower first premolar extraction space was closed using elastic power chain and 0.019X0.025 Stainless steel archwire into healed bony socket; Lower first premolar extraction space was closed using elastic power chain and 0.019X0.025 Stainless steel archwire into fresh bony socket
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Space closure into old extraction space
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: recent; healed; extraction space
Prevention of Dichloroacetate Toxicity
Condition: Acidosis, Lactic; Chronic Disease
MeSH terms: Acidosis; Acidosis, Lactic; Chronic Disease
Study type: Interventional

Summary: 
      This is a study to determine the safety of dichloroacetate (DCA) with a low-tyrosine diet
      given with or without nitisinone (NTBC) in children with chronic lactic acidosis (CLA).
    

Detailed description: 
      DCA is being studied for the treatment of patients with CLA, which is a rare collection of
      mitochondrial metabolism errors causing cellular energy failure and early death. DCA causes
      reversible liver and peripheral nerve toxicity and it interrupts both tyrosine and heme
      metabolism. The inhibitory effect of DCA on mammalian tyrosine metabolism elicits biochemical
      changes similar to those observed in hereditary tyrosinemia type I (HT). However, some
      reports and studies indicate substantial reduction in the biochemical and clinical
      consequences of HT may occur when patients are treated concomitantly with a low-tyrosine diet
      (LTD) and the chemical NTBC, which inhibits an early step in tyrosine catabolism. Possibly,
      the same dietary and pharmacologic interventions may mitigate or prevent toxicity associated
      with chronic DCA exposure.

      Patients visit the Center 5 times over a 1-year period, usually for 2 to 3 days per visit,
      for an extensive series of clinical and biochemical tests. Visit 1 is for baseline
      examinations and blood and urine chemistries and to educate the patient on an LTD. This visit
      lasts approximately 7 days to determine acceptable circulating tyrosine concentrations for
      LTD formula at discharge. Patients are provided with tubes to take to local laboratories
      every 2 weeks for blood work. Patients are readmitted in 1 month to determine adherence to
      diet and serum tyrosine levels. Patients who evidence dietary compliance, no adverse effects,
      and a willingness to continue are placed in 1 of 2 treatment arms: DCA plus an LTD plus
      placebo or DCA plus an LTD plus NTBC. Thereafter, patients return during Months 5, 9, and 13,
      which completes their 1-year treatment phase.

      Completion date provided represents the completion date of the grant per OOPD records
    

Intervention name(s): Nitisinone (NTBC); Dichloroacetate; Low-tyrosin diet
Intervention type(s): Drug; Drug; Behavioral
Intervention MeSH terms: Nitisinone
Allocation: Randomized
Masking: Double
Primary purpose: Prevention
Keywords: Tyrosine; Diet; 2-(2-nitro-4-trifluoromethylbenzoyl)-1,3-cyclohexanedione; 4-Hydroxyphenylpyruvate Dioxygenase; Enzyme Inhibitors
Randomized Study of HLA-mismatched DSI to Treat Relapse Leukemia After HLA- Matched Transplantation
Condition: Relapse Leukemia
MeSH terms: Leukemia; Recurrence
Study type: Observational

Summary: 
      The relapse leukemia patients after transplantation were divided into two groups randomly.
      Group D1: patients received first-donor stem cells infusion(DSI) treatment with or without
      chemotherapy; group D2: patients received second-donor DSI treatment with or without
      chemotherapy. The second donors were preferably donors who were genetically related and had
      more HLA-match locus. The re-induction chemotherapy regimen was primarily MAT(mitoxantrone,
      cytarabine, Teniposide ) for acute myeloid leukemia (AML) and VMCLD(vincristine, Teniposide,
      cyclophosphamide, L-Asparaginase, Dexamethasone) for acute lymphocytic leukemia (ALL), and no
      graft versus host disease(GVHD) prevention was conducted pre- and post- therapy.
    

Detailed description: 
      Evaluation indications include bone marrow morphology,hematopoietic recovery (neutrophil and
      platelet), 100-day transplantation-related mortality (TRM), donor chimerism, acute GVHD,
      chronic GVHD, disease free survival (DFS), and overall survival (OS). The cut-time of the
      follow-up was Oct, 2013. DFS was defined as the time between the date of transplantation to
      the death or relapse. OS was defined as the time from diagnosis to death or to the last date
      of follow-up until Oct. 2013.
    

Intervention name(s): the first donor's stem cell; the second donor's stem cell
Intervention type(s): Biological; Biological
Intervention description(s): HLA-matched stem cell infusion; HLA-mismatched, the second donor's stem cell infusion
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Eligible patients were between 9 and 67 years of age with de novo diagnosed or
        treated-related Acute leukemia relapsed after HLA-matched hematological stem cell
        transplantation from Feb 2005 to Feb 2013.
      
Biospecimen description: 
      the blood and bone marrow samples before and after transplantation and DSI
    
Keywords: relapse leukemia; DSI
Levofloxacin In The Treatment Of Children With Recurrent And/or Persistent Acute Otitis Media
Condition: Otitis Media
MeSH terms: Otitis; Otitis Media
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to demonstrate non-inferiority of levofloxacin compared with
      amoxicillin/clavulanate on the clinical response at the end of therapy in infants and
      children who have recurrent and/or persistent acute otitis media.
    

Detailed description: 
      This is a randomized, active-comparator, multicenter study consisting of 3 phases: a
      Pretreatment (Screening) Phase, a Treatment Phase, and a Posttreatment Phase. Subject
      eligibility will be determined at the screening visit based on signs and symptoms of acute
      otitis media (e.g., middle ear effusion, acute inflammation, acute purulent otorrhea) and
      criteria for recurrent and/or persistent acute otitis media. Eligible subjects will be
      randomized and drug will be dispensed by a study coordinator who will instruct parents and
      the subject about the importance of not revealing the assigned therapy to the subject's
      evaluator. Each subject will have an evaluator who will remain blinded to the subject's
      therapy throughout the study. Clinical assessments performed by a blinded evaluator at
      several time points throughout the study will be used to evaluate efficacy. Safety will be
      evaluated throughout the study by assessment of adverse events and changes in physical
      examinations (including musculoskeletal examination with evaluation of joints), vital signs,
      and clinical laboratory findings. Supplementary safety evaluations for musculoskeletal
      adverse events will be performed throughout the study. All subjects who enroll in this study
      and take at least 1 dose of levofloxacin or amoxicillin/clavulanate will be eligible to
      rollover into a long-term surveillance study primarily focused on the musculoskeletal system.
      The purpose of this study is to demonstrate non-inferiority of levofloxacin compared with
      amoxicillin/clavulanate on the clinical response at the end of therapy in infants and
      children who have recurrent and/or persistent acute otitis media. Either levofloxacin 10
      mg/kg twice daily for 10 days (maximum daily dose of 500 mg) or amoxicillin/clavulanate
      (14:1) 45 mg amoxicillin/kg twice daily for 10 days (maximum daily dose of 3600 mg
      amoxicillin). Both study drugs will be given orally as a liquid suspension formulation
    

Intervention name(s): levofloxacin; amoxicillin/clavulanate
Intervention type(s): Drug
Intervention MeSH terms: Amoxicillin; Levofloxacin; Clavulanic Acid; Clavulanic Acids; Amoxicillin-Potassium Clavulanate Combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Otitis Media; Acute Otitis Media; ear infection; levofloxacin; amoxicillin; clavulanate
Phase III Clinical Trial Comparing the Safety, Efficacy, and Immunogenicity of HS022 and Trastuzumab® in Combination With Vinorelbine Bitartrate Injection in the Treatment of HER2-positive Breast Cancer
Condition: HER2-positive Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multi-center, randomized, double-blind, parallel-group study to evaluate the
      efficacy and safety and Immunogenicity of Vinorelbine Bitartrate Injection in Combination
      With HS022 and Trastuzumab®.There were 2 parts. Part 1 needs 8 treatment cycles ( at least 24
      weeks); Part2 needs 9 treatment cycles (at least 27 weeks).
    


Intervention name(s): HS022; Trastuzumab; Vinorelbine Bitartrate
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 8 treatment cycles, 3 weeks/cycle, 24 weeks. The first dose is 8 mg/kg , and then 6 mg/kg .3 weeks/cycle, continue until the disease progresses, intolerable toxic reaction occurs, or the subject voluntarily withdraws from the clinical trial, whichever occurs first.
The second stage 9 treatment cycles, 3 weeks/cycle, 27 weeks. 6mg/kg; 8 treatment cycles, 3 weeks/cycle, 24 weeks. The first dose is 8 mg/kg , and then 6 mg/kg .3 weeks/cycle, continue until the disease progresses, intolerable toxic reaction occurs, or the subject voluntarily withdraws from the clinical trial, whichever occurs first.
The second stage 9 treatment cycles, 3 weeks/cycle, 27 weeks. 6mg/kg; Vinorelbine: 25mg/m2 (intravenous infusion, day 1 and 8 of each cycle). 3 weeks/cycle, continue until the disease progresses, intolerable toxic reaction occurs, or the subject voluntarily withdraws from the clinical trial, whichever occurs first.
Second section:9 treatment cycles, 3 weeks/cycle, 27 weeks. Vinorelbine: 25mg/m2 (intravenous infusion, day 1 and 8 of each cycle). The investigator may decide whether to continue treatment with vinorelbine at his discretion.
3 weeks/cycle, continue until the disease progresses, intolerable toxic reaction occurs, or the subject voluntarily withdraws from the clinical trial, whichever occurs first.
Intervention MeSH terms: Trastuzumab; Vinorelbine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Investigating the Role of Ghrelin in Regulating Appetite and Energy Intake in Patients Following Bariatric Surgery (BARI-INSIGHT)
Condition: Obesity; Bariatric Surgery Candidate; Appetitive Behavior
MeSH terms: Obesity
Study type: Interventional

Summary: 
      Bariatric surgery helps patients with severe obesity to lose weight, cures and prevents
      diseases linked to obesity and reduces the risk of death. Unfortunately, 1 in 5 patients do
      not respond well to surgery in terms of weight loss and health gains. Thus, maximising weight
      loss and health benefits after surgery is critical. This study aims to gain insight into the
      role that the appetite-stimulating hormone, ghrelin, plays in driving appetite and energy
      intake in patients with poor weight loss (≤ 20% total body weight) following bariatric
      surgery. This will guide future work to develop pharmacological treatments for obesity, both
      as standalone treatments and adjuncts to bariatric surgery.

      Participants will be invited to attend the Clinical Research Facility at University College
      London Hospital for a screening visit and six study visits. Active ghrelin levels will be
      reduced by inhibiting ghrelin-o-acyl-transferase (GOAT), the enzyme needed to generate active
      ghrelin (acyl ghrelin, AG). Participants will be randomised to receive GLWL-01 (GOAT
      inhibitor) 300mg BD or placebo for a 10 day study cycle. The effect of AG reduction on
      appetite and energy intake will be evaluated through both fixed-energy and ad libitum meal
      tests on day 7 and 10, respectively. Measures of body weight and composition, appetite and
      food cravings will be performed in addition to biochemical profiling of circulating gut
      hormone, adipokine and cytokine levels. Targeted physical examinations and assessment of
      adverse events will be performed. Safety monitoring calls will be conducted 2 and 7 days
      after the last dose. Following a 6-10 week washout period, participants will cross over to
      receive either placebo or GLWL-01 300mg BD and undergo a second study cycle, with all
      measures repeated.
    


Intervention name(s): GLWL-01; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Small molecule inhibitor of Ghrelin-O-Acyltransferase (GOAT) to reduce levels of circulating acyl ghrelin.
(Defined as a mechanistic study by MHRA; intervention not for therapeutic purposes in this study.); Same as GLWL-01, but no active ingredient
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Double blind, placebo-controlled, within-subject, crossover mechanistic study
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Obesity; Bariatric surgery; Appetite; Ghrelin; Energy intake; Gut hormones; Adipokines
Impact of DNA Fragmentation in Sperm on Pregnancy Outcome After Intra-uterine Insemination in a Spontaneous Cycle
Condition: Infertility Unexplained; Infertility, Male; DNA Damage
MeSH terms: Infertility; Infertility, Male
Study type: Interventional

Summary: 
      Infertility affects about 10% of all couples and is defined by a failure to achieve a
      clinical pregnancy within a year of regular unprotected sexual intercourse. Up to one third
      of these couples will not have an identifiable cause after routine investigation, id est
      idiopathic infertility. The current diagnosis of male infertility relies on the World Health
      Organization (WHO) 2010 criteria which focus on concentration, motility and morphology in
      comparison to cut-off values of a fertile population. Alas, the relevance of the conventional
      semen analysis for the choice of treatment and the predictive value for an infertile couple
      with idiopathic or mild male infertility embarking on medically assisted reproduction (MAR)
      remains questionable. In other words, there is a strong clinical need to distinguish fertile
      from infertile men through new sperm function testing and to be able to select both the
      patient population who will benefit from MAR as well as the type of treatment.

      Numerous studies utilizing different techniques for assessing sperm DNA fragmentation support
      the existence of a significant association between sperm DNA damage and pregnancy outcomes.

      In this prospective cohort study the investigators aim to study the role of sperm DNA
      fragmentation analysis in selecting the patient who will benefit from intra-uterine
      insemination (IUI) therapy since IUI is still considered the first step in MAR and is
      performed at a large scale in Belgium and worldwide.
    


Intervention name(s): DNA fragmentation by TUNEL assay
Intervention type(s): Diagnostic Test
Intervention description(s): Direct DNA fragmentation testing with terminal deoxyuridine nick end labeling (TUNEL) assay.
Intervention model: Single Group Assignment
Intervention model description: Single center, university setting, no commercial affiliation
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Unexplained Infertility; Idiopathic Infertility; DNA damage; DNA fragmentation; Insemination
A Study to Evaluate SAGE-217 in Participants With Essential Tremor
Condition: Essential Tremor
MeSH terms: Tremor; Essential Tremor
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is a three-part, multicenter, Phase 2a study to evaluate the efficacy, safety,
      tolerability, and pharmacokinetics of SAGE-217 in adult participants with essential tremor.
    

Detailed description: 
      Part A of the study was an open-label design with morning dosing of SAGE-217 for 7 days and
      included 16 participants, 8 of whom qualified for, and entered, Part B.

      Part B had a double-blind, placebo-controlled, randomized withdrawal design with morning
      dosing for 7 days.

      Part C was an open-label design with morning and evening dosing for 14 days and included a
      different set of 18 participants.

      Parts A and B were stopped early (in advance of the planned sample size).

      This study was previously posted by Sage Therapeutics. In November 2023, sponsorship of the
      trial was transferred to Biogen.
    

Intervention name(s): SAGE-217; SAGE-217; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): SAGE-217 Oral Solution; SAGE-217 Capsules; SAGE-217 matching placebo capsules
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Tremor
CoV-PICS: A Virtual Post-ICU Clinic
Condition: Post ICU Syndrome
MeSH terms: Syndrome
Study type: Interventional

Summary: 
      This is a pilot study to evaluate the feasibility of a COVID-19 virtual Post Intensive Care
      Syndrome (PICS) clinic (CoV-PICS). The findings from this study are the first steps in
      determining the feasibility and potential impact of a telehealth PICS clinic that is able to
      address the needs of patients with COVID-19 disease and potentially other patients that are
      unable to attend a brick and mortar clinic and require virtual care.
    


Intervention name(s): Medical Record Review - Inpatient Treatment; Online Questionnaires
Intervention type(s): Other; Other
Intervention description(s): Patient characteristics, medical history, and information regarding their inpatient treatment from the electronic medical record; Patients will complete online questionnaires related to their physical, cognitive and mental health function and inquire about current treatments. The multiprofessional CoV-PICS clinic practitioners will evaluate their responses and, combined with information obtained during their virtual visits, formulate a suggested treatment plan and needed referrals.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
The Role of Follicle Stimulating Hormone in Advanced Prostate Cancer
Condition: Prostate Cancer Recurrent
MeSH terms: Prostatic Neoplasms
Study type: Interventional

Summary: 
      In order to elucidate if FSH can have testosterone like effects, samples from young,
      non-smoking healthy volunteers, with normal body mass index, and with pharmacologically
      induced gonadotropin deficiency will be studied regarding their capacity to induce prostate
      specific antigen (PSA), which normally is regulated by testosterone.
    

Detailed description: 
      Normally, prostate specific antigen (PSA), which is a marker for prostate disease and
      progression, is exclusively produced in response to testosterone. In order to elucidate if
      follicle stimulating hormone (FSH) can have testosterone like effects, samples from n=30
      non-smoking healthy volunteers, 20-30 years of age and with normal body mass index (20-25)
      with pharmacologically induced gonadotropin deficiency will be studied. The men are currently
      recruited and during 5 weeks undergoing:

        1. Pharmacologically induced gonadotropin deficiency w 1-3;

        2. FSH-treatment of 50% (group A), w 1-5;

        3. Testosterone (T) treatment of all (group A and B) w 4-5;

        4. End and follow up after 5 weeks.

      A subcutaneous injection with the GnRH antagonist degarelix (240 mg¸ Ferring GmbH Wittland,
      Kiel, Germany) results in drop of both FSH and LH-induced testosterone. Half of the men will
      get recombinant FSH (300 IU; Gonal-f, Merck Serrono S.A. Aubonne, Schweiz) back, whereas 50%
      will not. Three weeks thereafter, the full spectrum of FSH dependent changes occur and are
      reflected in blood. From this occasion testosterone (Nebido, Ferring GmbH Wittland, Kiel,
      Germany) will be given to all participants to diminish the side-effects of the castration.
      Blood samples are collected at start, after 3 wks and after 5 wks. At that point also a
      follow up is undertaken. This experimental design will provide samples from each individual
      during normal conditions, during castration, and after a standardised dose of FSH.
    

Intervention name(s): Degarelix 120 MG [Firmagon]; Gonal F RFF Pen 900 UNT Per 1.5 ML Pen Injector; Testosterone Undecanoate
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Two doses of degarelix, 240 mg, subcutaneously once, at study start.; Gonal-f 300 IU subcutaneously 3 times per week for 5 weeks.; One dose 1000 mg testosterone once, after 3 weeks.
Other intervention name(s): Firmagon; Gonadotropin; Nebido
Intervention MeSH terms: Methyltestosterone; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized case control study: one arm with FSH treatment for 5 weeks and one arm without FSH.
Masking: None (Open Label)
Primary purpose: Other