bioihbjkbjnl/mcl2 huggingface dataset:
Biomechanics Based Prediction of Preterm Delivery
Condition: Preterm Delivery
MeSH terms: Premature Birth
Study type: Observational

Summary: 
      Quantitative information on the biomechanical properties of the ecto-cervix in mid-pregnancy
      will be compared between women with term vs. preterm delivery. We aim to demonstrate that
      biomechanical data (ASP and CCI) might complement morphological data (CL) to improve
      prediction of preterm delivery. It is expected that women with preterm delivery will show
      stronger weakening of cervical tissue. Aspiration (ASP) and cervical CCI (cervical
      consistency index) measurements are performed at mid-pregnancy: detection at this time point
      is useful for therapy and biomechanical modifications are already significant so to enable
      differentiation by biomechanical measurements (ASP and CCI).
    


Intervention name(s): Pregnolia System
Intervention type(s): Device
Intervention description(s): No intervention is done except for measuring the stiffness of the cervix in pregnant women
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All pregnant women at our institutions between 18+0/7 and 22+0/7 weeks of pregnancy and
        postpartum
      
Keywords: Preterm delivery; Diagnostics; Biomechanics
Predictors of Para-aortic Lymph Node Metastasis of Cervical Cancer
Condition: Locally Advanced Cervical Cancer
MeSH terms: Uterine Cervical Neoplasms; Lymphatic Metastasis
Study type: Observational

Summary: 
      The goal of this observational study is to identify predictive factors and to develop a risk
      model predicting para-aortic lymph node metastasis in patients with locally advanced cervical
      cancer based on the analysis of surgical staging results. The main questions it aims to
      answer are:

        -  What are the risk factors to predict para-aortic lymph node metastasis in patients with
           locally advanced cervical cancer?

        -  What is the indication for prophylactic extended-field radiation therapy in patients
           with locally advanced cervical cancer Individual data of patients with locally advanced
           cervical cancer treated with surgical staging at our institution from 2020 to 2022 were
           pooled analysed.Multivariate Logistic regression analysis was used to identify the
           predictive factors and to develop the prediction model.
    

Detailed description: 
      Individual data of 336 patients with locally advanced cervical cancer treated with surgical
      staging at our institution from January 2020 to August 2022 were pooled analysed. The
      following factors were collected from each patient to identify variables predicting
      para-aortic lymph node metastasis: age, T-staging，histopathological type，tumor size,
      differentiation, pretreatment tumor markers (squamous carcinoma antigen, carcinoembryonic
      antigen, Carbohydrate antigen 125 and cytokeratin fragment 21-1 , human papilloma virus type,
      the status of pelvic lymph node on images, common iliac lymph node and the short-axis
      diameter of the largest positive and the status of para-aortic lymph node on surgical staging
      results. Multivariate Logistic regression analysis was used to develop the prediction model.
      A simplified scoring system for each independent predictive factors was developed according
      to its coefficient. Internal validation was performed to assess the model. An independent
      validation cohort contained 116 patients with the same criteria from March 2018 to December
      2019.
    

Intervention name(s): surgical staging
Intervention type(s): Procedure
Intervention description(s): para-aortic lymphadenectomy from the inferior mesenteric artery cranially to the aorta caudally via laparoscopy or laparotomy
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        The primary cohort of this study comprised an evaluation of the institutional database for
        medical records from January 2020 to August 2022 to identify patients with locally advanced
        cervical cancer who underwent surgical staging.

        From March 2018 to December 2019, an independent validation cohort of 116 consecutive
        patients was screened using the same criteria as that for the primary cohort.
High-Dose Chemotherapy Followed by Total-Body Irradiation and Peripheral Stem Cell Transplantation in Treating Patients With Chronic Lymphocytic Leukemia
Condition: Leukemia
MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
      so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer
      cells. Combining chemotherapy and radiation therapy with peripheral stem cell transplantation
      may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.

      PURPOSE: Phase I trial to study the effectiveness of high-dose combination chemotherapy
      followed by total-body irradiation and peripheral stem cell transplantation in treating
      patients with chronic lymphocytic leukemia.
    

Detailed description: 
      OBJECTIVES: I. Evaluate engraftment after autografting with CD34 selected peripheral blood
      stem cells (PBSC) in patients with chronic lymphocytic leukemia (CLL). II. Evaluate the
      efficacy of CD34 selection for purging CLL from PBSC collection. III. Determine the
      effectiveness of mobilization chemotherapy with cyclophosphamide, etoposide, and
      dexamethasone plus filgrastim (granulocyte colony-stimulating factor) to mobilize PBSC in
      these patients. IV. Describe toxicity and disease response to a conditioning regimen of total
      body irradiation and cyclophosphamide in these patients.

      OUTLINE: There are 3 phases to the treatment plan: Cytoreductive chemotherapy can be given by
      conventional chemotherapy. Patients are treated until at least a good partial remission.
      Patients will have CD34 selected peripheral blood stem cells (PBSC) stored after treatment
      with mobilization chemotherapy followed by filgrastim (granulocyte colony-stimulating factor;
      G-CSF). Cyclosphosphamide (CTX) IV is given over 1 hour. Etoposide (VP-16) is given over 1-2
      hours on day 2. Dexamethasone is given 4 times a day on days 1-3. G-CSF is given
      subcutaneously daily beginning 2 days after chemotherapy and continuing until PBSC collection
      is completed. At least 4 weeks should ensue after mobilization chemotherapy before proceeding
      with the transplant. Patients are treated with TBI on days -6, -5, and -4 and CTX on days -3
      and -2. PBSC are infused on day 0.

      PROJECTED ACCRUAL: A total of 15 patients will be entered in this study.
    

Intervention name(s): filgrastim; cyclophosphamide; dexamethasone; etoposide; peripheral blood stem cell transplantation; radiation therapy
Intervention type(s): Biological; Drug; Drug; Drug; Procedure; Radiation
Intervention MeSH terms: Dexamethasone; Cyclophosphamide; Etoposide
Primary purpose: Treatment
Keywords: stage III chronic lymphocytic leukemia; stage IV chronic lymphocytic leukemia; refractory chronic lymphocytic leukemia; B-cell chronic lymphocytic leukemia
Mechanical Control of Plaque in Patients With Cerebral Palsy: A Randomized Clinical Trial
Condition: Cerebral Palsy;; Dental Plaque
MeSH terms: Dental Plaque; Paralysis; Cerebral Palsy
Study type: Interventional

Summary: 
      The aim of the present study was to determine the effectiveness of brushing with an electric
      toothbrush switched on and switched off in comparison to manual brushing for the removal of
      dental plaque in children aged four to 16 years with cerebral palsy.
    

Detailed description: 
      Advances in the design and type of movement of electric toothbrushes can determine the
      increase in effectiveness in the control of biofilm by caregivers and patients.There is a
      paucity of studies evaluating the effectiveness of the electric toothbrush compared to manual
      toothbrush specifically in patients with cerebral palsy.Only one study used the electric
      toothbrush in patients with cerebral palsy and demonstrated superiority of the electric
      toothbrush over the manual. However, the study investigated the effect of various cleaning
      strategies on symptoms of gingival inflammation, not specifically focusing on the comparison
      of the efficiency of removal of biofilm from the manual toothbrush and electric toothbrush.
      The primary objective of this study was to evaluate the effectiveness of the electric brush
      on and off the removal of dental plaque in subjects with cerebral palsy compared to manual
      toothbrush. The secondary objective was to characterize the study as socioeconomic
      population.
    

Intervention name(s): manual brushing; electric toothbrush linked; off electric toothbrush
Intervention type(s): Device; Device; Device
Intervention description(s): Tooth brushing; Tooth brushing; Tooth brushing
Other intervention name(s): manual brushing; (Oral-B®, Stages 4, Rio de Janeiro, Rio de Janeiro); electric toothbrush linked; Braun - Oral-B®, D2010K, Rio de Janeiro, Rio de Janeiro; off electric toothbrush; Braun - Oral-B®, D2010K, Rio de Janeiro, Rio de Janeiro
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Cerebral Palsy;; Toothbrushing;; Dental Plaque
Comparison of Three Different Pain and Anxiety Reducing Methods in Adult Patients Undergoing Bone Marrow Puncture
Condition: Patients Undergoing Puncture of the Bone Marrow
MeSH terms: Wounds and Injuries
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to investigate and compare the effects of three different
      methods for reducing pain and anxiety in adult patients undergoing puncture of the bone
      marrow. The investigated methods are: cognitive behavioural technique, administration of a
      sedative drug(Midazolam) and administration of an analgetic drug (Piritramid)prior to the
      procedure. Additionally, there are two comparison groups in which the patients receive either
      placebo treatment or no treatment at all.
    

Detailed description: 
      The puncture of the bone marrow is a routine medical procedure which is often performed in
      the field of hematology/oncology. When carefully and appropriately performed, the puncture of
      the bone marrow has a very low rate of complications and is generally safe for the patient.
      However, it is an invasive and painful procedure associated with anxiety, especially in
      patients undergoing repeated punctures. Therefore an appropriate preparation of the patient
      for the puncture is essential in order to minimize the stress experienced during the
      procedure. In this regard, there are numbers of both pharmacological and non-pharmacological
      interventions in pedriatric patients aimed at reducing the punction related pain and anxiety
      in this patients. Nevertheless an evidence based approach for the pretreatment of the
      patients is yet to be established. The aim of this study is to investigate three different
      methods for reducing the pain and anxiety associated with the puncture of the bone marrow in
      adult patients. Two of the of the investigated methods involve pretreatment of the patients
      with pharmacological agents (sedative drug or analgetic drug), whereas the third method
      involves cognitive behavioural pretreatment in form of an audio material. The patients in the
      control group receive placebo injections.
    

Intervention name(s): Midazolam (sedative); Piritramid (analgetic); Cognitive exercises
Intervention type(s): Drug; Drug; Behavioral
Intervention MeSH terms: Midazolam; Pirinitramide; Hypnotics and Sedatives
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: Bone marrow puncture; Pain
NPC-12G Gel 0.2% Sirolimus PK Bridging Study
Condition: Bioavailability Study
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to describe the relative systemic bioavailability of topical and oral
      sirolimus formulations.
    


Intervention name(s): NPC-12G Gel 0.2%; Rapamune® 2 mg tablet
Intervention type(s): Drug; Drug
Intervention description(s): Period 1; Period 2
Other intervention name(s): 2 mg of sirolimus in 1 g of gel; Sirolimus
Intervention MeSH terms: Sirolimus; Temsirolimus; MTOR Inhibitors
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Other
Efficacy and Safety of Intracoronary Ad5FGF-4 in Patients With Stable Angina (AGENT-3)
Condition: Angina Pectoris
MeSH terms: Angina Pectoris; Angina, Stable
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to determine whether a single intracoronary infusion of Ad5FGF-4
      is effective in improving exercise capacity measured by exercise treadmill testing, angina
      functional class, patient symptoms, quality of life, and cardiovascular outcomes. Two doses
      will be studied, 2.87 x 10(8) and 2.87 x 10(9) viral particles, to evaluate the dose-response
      of Ad5FGF-4. Short-term and long-term safety of Ad5FGF-4 will also be evaluated.
    


Intervention name(s): Ad5FGF-4 vs. Placebo
Intervention type(s): Genetic
Intervention description(s): Intracoronary infusion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: angina; FGF-4; angiogenesis; adenovector; growth factor; myocardial ischemia; revascularization
Measurement of the Free Fraction of 25-hydroxyvitamin D in Serum
Condition: Impaired Glucose Tolerance
MeSH terms: Glucose Intolerance
Study type: Observational

Summary: 
      In the circulation 25-hydroxyvitaminD (25(OH)D) is bound to the vitamin D binding protein
      (DBP) and albumin. According to the free hormone hypothesis, it is, however, the free
      fraction that is biologically active. Polymorphisms in DBP are related to the serum level of
      25(OH)D. As these polymorphisms may also affect the binding affinities for 25(OH)D, the total
      serum 25(OH)D may not necessary reflect the free fraction. To test this hypothesis, we will
      calculate the free fraction of 25(OH)D by correction for DBP and albumin content, and also
      measure free 25(OH)D from equilibrium dialysis and ultra filtration. Furthermore, we will
      relate total serum 25(OH)D as well as the free and biologically active (free- albumin-bound)
      25(OH)D to the well established vitamin D effect marker serum parathyroid hormone as well as
      to the RNA expression in peripheral blood to evaluate the biological importance of the free
      versus the total fraction of 25(OH)D. We will invite 300 subjects from an ongoing vitamin D
      supplementation study to participate in the study which will be one visit only and include
      collection of blood samples.
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Subjects with known impaired glucose tolerance
Study to Assess the Effect of Pharmacokinetics/Pharmacodynamics (PK/PD) Interaction After co-Administration of Cilostazol With Ginkgo Biloba or Placebo
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      TO assess the PK/PD effect of co-administerd Cilostazol with Ginkgo biloba or placebo, Phase
      I study in healthy Volunteers were designed
    


Intervention name(s): Cilostazol, Ginkgo biloba and placebo
Intervention type(s): Drug
Intervention description(s): dosing time
Intervention MeSH terms: Cilostazol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Healthy volunteers
Study of Wrist Fusions With the Medartis Aptus Arthrodesis Plate
Condition: Wrist Arthritis; Wrist Osteoarthritis
MeSH terms: Arthritis; Osteoarthritis
Study type: Observational

Summary: 
      The primary working hypothesis of this study is whether wrist arthrodesis leads to an
      improvement in functional status in both rheumatoid arthritis and post-traumatic
      osteoarthritis. Functional status will be measured by Disabilities of the Arm, Shoulder and
      Hand (DASH) questionnaire no earlier than 1 year after surgery.
    


Intervention name(s): Total wrist fusion
Intervention type(s): Procedure
Intervention description(s): Observation after implantation of Medartis Aptus Wrist Arthrodesis Plate
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Individuals who have either suffered wrist destruction due to rheumatiod arthritis
        inflammation, or individuals who have received wrist fusion due to post-traumatic
        osteoarthritis.
      
Keywords: Wrist fusion,Arthrodesis,Rheumatoid Arthritis,Osteoarthritis
A Pharmacokinetic and Tolerance Study of Oral Ganciclovir in HIV-Infected Children With Asymptomatic Cytomegalovirus Infection and Low CD4 Cell Counts or Quiescent Cytomegalovirus Disease
Condition: Cytomegalovirus Infections; HIV Infections
MeSH terms: Infections; Communicable Diseases; Cytomegalovirus Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      PRIMARY: To determine the pharmacokinetics, MTD, and long-term safety and tolerance of oral
      ganciclovir in HIV-infected infants, children, and adolescents.

      SECONDARY: To evaluate the effect of oral ganciclovir on the virologic parameters of CMV.

      Maintenance treatment with intravenous (IV) ganciclovir for cytomegalovirus retinitis in AIDS
      patients is now standard therapy, but daily IV therapy can be complicated by catheter
      infections and thrombosis. An oral regimen of ganciclovir has been administered safely in
      adult AIDS patients and may be of significant benefit to children and infants as well.
    

Detailed description: 
      Maintenance treatment with intravenous (IV) ganciclovir for cytomegalovirus retinitis in AIDS
      patients is now standard therapy, but daily IV therapy can be complicated by catheter
      infections and thrombosis. An oral regimen of ganciclovir has been administered safely in
      adult AIDS patients and may be of significant benefit to children and infants as well.

      Patients are assigned to 1 of 5 (PER AMENDMENT 10/24/95, was 4) oral (syrup or capsules) dose
      levels following a single intravenous dose of ganciclovir. Treatment continues for 72 (PER
      AMENDMENT 10/24/95, was 24 weeks) weeks after the last patient has been enrolled.
    

Intervention name(s): Ganciclovir
Intervention type(s): Drug
Intervention MeSH terms: Ganciclovir; Ganciclovir triphosphate
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ganciclovir; Cytomegalovirus Infections; Acquired Immunodeficiency Syndrome
Pharmacokinetics of GH001 in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to investigate the serum pharmacokinetics of 5-MeO-DMT
      and its metabolite, bufotenine in healthy volunteers in a double-blind, placebo-controlled,
      randomized study design with single, inhaled doses of GH001 and in an open-label,
      non-randomized study design with intra-subject dose-escalation of GH001. As a secondary
      objective, the safety and tolerability of GH001, the mental health and well-being of the
      subjects after GH001 dosing(s), the pharmacodynamic profile of GH001 as evaluated by its
      psychoactive effects, and cognitive measures are also assessed.
    


Intervention name(s): 5 Methoxy N,N Dimethyltryptamine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): GH001 administered via inhalation; GH001 Placebo administered via inhalation
Other intervention name(s): GH001; 5-MeO-DMT; GH001 Placebo
Intervention MeSH terms: N,N-Dimethyltryptamine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study will include separate single- and multiple-dose parts.
Single-dose Part:
A double-blind, placebo-controlled, randomized, parallel-group design with single, inhaled doses of GH001 in 3 groups of 10 subjects (randomized as 8 active and 2 placebo subjects per group):
Group A: single inhaled dose of 6 mg GH001
Group B: single inhaled dose of 12 mg GH001
Group C: single inhaled dose of 18 mg GH001
Multiple-Dose Part:
An open-label, non-randomized administration of up to 3 inhaled doses of GH001 within a single day (6 mg, followed by 12 mg, followed by 18 mg) with two different dose intervals (8 subjects per group):
Group D: 1-hour interval
Group E: 2-hour interval
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: 5-MeO-DMT; 5-methoxy-N,N-dimethyltryptamine; 5-methoxy-dimethyltryptamine; Healthy Volunteers; Pharmacokinetics