bioihbjkbjnl/mcl2 huggingface dataset:
Gender Differences in Pediatric Hematopoietic Stem Cell Transplantation (HSCT)
Condition: Hematopoietic Stem Cell Transplantation
Study type: Observational

Summary: 
      Gender medicine considers the way in which gender, male or female, affects the development
      and impact of diseases and the response to therapies. It can be said that it is a new
      transversal dimension of medicine, which evaluates the gender differences in the physiology,
      pathophysiology and clinic of many diseases and thus sets itself the goal of reaching optimal
      therapeutic decisions both in men and women based on proven scientific evidence.

      Although knowledge of gender medicine has increased significantly in recent years, a gender
      approach has not been much developed in pediatrics. In the field of bone marrow transplants,
      hematopoietic stem cell transplantation is known to be the most effective consolidation
      therapy in some high-risk hematology malignancies such as acute lymphoblastic leukemia and
      acute myeloid leukemia, and represents one of the potential treatment for patients suffering
      from solid tumors and genetic hematological, metabolic diseases and primary
      immunodeficiencies. Huge progress has been made in high resolution donor typing, choice of
      conditioning regimens, manipulation of hematopoietic stem cells (HSC) and prevention of
      serious infections in recent years, which have significantly improved the survival rate of
      patients undergoing to this procedure.

      International literature regarding the response and outcomes from hematopoietic cell
      transplantation in a gender perspective is completely absent, for these reasons this pilot
      study was born from the need to understand from a broader perspective and in order to better
      understand how the gender may or not influence the outcome of transplantation in pediatric
      patients.

      This retrospective analysis of the data will concern all patients who underwent allogeneic or
      autologous bone marrow transplant. The data will be collected from clinical records and from
      Regional electronic databases. All data will be collected anonymously and an identification
      code will be assigned to each case.
    


Intervention name(s): Hematopoietic stem cell transplantation
Intervention type(s): Procedure
Intervention description(s): Allogeneic or autologous bone marrow transplant
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Population of pediatric patients undergoing hematopoietic stem cell transplantation
      
Keywords: gender, pediatrics, hematopoietic cell transplantation
Long-term Safety and Efficacy of Prebiotic Enriched Infant Formula
Condition: Infection; Microbial Colonization; Healthy
MeSH terms: Infections; Communicable Diseases
Study type: Interventional

Summary: 
      The primary objective of the present study was to evaluate the effects of long-term
      supplementation of an infant formula supplemented with prebiotic inulin-type oligosaccharides
      on immunological-health related outcomes.
    

Detailed description: 
      The study primarily aimed to evaluate the effects of long-term supplementation of an infant
      formula with a mixture of short and long chain inulin-type oligosaccharides on
      immunological-health related outcomes, as well as on gastrointestinal function and well-being
      in infants during the first year of life. Effects on infant growth, tolerance and on the
      composition of fecal microbiota were further objectives of this study. The study was
      conducted as a multicenter, randomised, double-blind, placebo-controlled study in healthy
      term infants. The two groups of the study are product group (standard infant formula
      supplemented with inulin-type fructans) and control group (non-supplemented standard infant
      formula).
    

Intervention name(s): Supplemented formula; Standard formula
Intervention type(s): Other; Other
Intervention description(s): standard infant formula supplemented with 8 g/L prebiotic inulin-type fructans; standard infant formula not supplemented with prebiotic inulin-type fructans
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Carboplatin AUC-10 With Early PET Scanning in Metastatic Seminoma
Condition: Metastatic Seminoma
MeSH terms: Seminoma
Study type: Interventional
Phase: Phase 2

Summary: 
      This study evaluated the safety, efficacy and toxicity of carboplatin area under the curve
      (AUC)-10 in metastatic seminoma to see if, by using fluoro-deoxyglucose (FDG) positron
      emission tomography-computed tomography (PET-CT) to assess metabolic response, the number of
      patients requiring 4 cycles can be reduced. Carboplatin AUC-10 was given every 21 days. A
      PET-CT scan was carried out on day 17-21 of the first cycle. If the PET - CT scan showed a
      complete response patients received 3 cycles of treatment. If the PET - CT scan did not show
      a complete response patients received 4 cycles of treatment. After treatment, patients were
      followed up for 2 years.
    


Intervention name(s): Carboplatin AUC-10
Intervention type(s): Drug
Intervention description(s): Carboplatin AUC-10 according to the Calvert formula [10 x (glomerular filtration rate (ml/min) + 25)]mg given in 5% glucose over 1 hour every 21 days for 3 or 4 cycles.
Intervention MeSH terms: Carboplatin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Adipose Cells for Degenerative Disc Disease
Condition: Degenerative Disc Disease
MeSH terms: Spinal Diseases; Intervertebral Disc Degeneration
Study type: Interventional

Summary: 
      The intent of this clinical study is to answer the questions: 1) Is the proposed treatment
      safe and 2) Is treatment effective in improving the disease pathology of patients with
      diagnosed degenerative disc disease.
    

Detailed description: 
      This will be an open-label, non-randomized, multi-center study of ASC implantation performed
      intra-discally. ASCs will be derived from the patient's adipose-derived tissue. Liposuction
      using local anesthesia and syringe collection will be performed to collect the adipose tissue
      specimen for subsequent processing to isolate the stem cells.

      The adipose tissue specimen will be collected from the patient's abdomen using a liposuction
      cannula. In addition, a sample of peripheral blood will be collected for isolation of
      platelet rich plasma. The adipose tissue is processed for separation of the adipose
      tissue-derived stem cells, which are then resuspended in platelet rich plasma and transferred
      for intra-discal administration. The number of cells injected will vary depending on the
      amount of tissue processed and the number of cells obtained from the process. Following the
      injections follow-up data will be collected 3, 6 and 12 months after treatment.

      Total study time frame is anticipated to be approximately 6 months. This study will enroll
      approximately 100 patients.
    

Intervention name(s): Adipose Stem Cells
Intervention type(s): Procedure
Intervention description(s): Injection of adipose derived stem cells intra-discally
Intervention model: Single Group Assignment
Primary purpose: Treatment
Keywords: Degenerative Disc Disease; Disc Disease; Back pain; stem cells; adipose stem cells; ADSCs
TEAS to Reduce Propofol Consumption During General Anesthesia
Condition: Anesthesia
Study type: Interventional

Summary: 
      The study is aimed at whether transcutaneous electrical acupoint stimulation (TEAS) during
      general anesthesia could reduce the need for propofol in patients undergoing minor surgery.
    


Intervention name(s): acupoint stimulation; non-acupoint stimulation; electrodes attached
Intervention type(s): Other; Other; Other
Intervention description(s): stimulation was given at acupoints; stimulation was given at non-acupoints; electrode were attached to skin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Wavefront Analyzes and Visual Performance of Three Multifocal Intra-ocular Lenses
Condition: Cataract; Astigmatism
MeSH terms: Cataract; Astigmatism
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to determine if differences in the design of multifocal
      intra-ocular lenses would mean different values of higher-order aberrations and different
      performance in objective parameters such as modulation transfer function.
    


Intervention name(s): Tecnis implant; ReSTOR implant; ReZoom implant
Intervention type(s): Device; Device; Device
Intervention description(s): Implant of diffractive multifocal IOL Tecnis; Implant of multifocal IOL ReSTOR; Implant of multifocal IOL ReZoom
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: wavefront; multifocal IOL; modulation transfer function; intraocular lenses; wavefront data; Visual performance
Vildagliptin Versus Dapagliflozin on Glucagon
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of the study is to assess if vildagliptin and dapagliflozin have dissociated effects
      on glucagon secretion after a mixed meal ingestion in metformin-treated subjects with type 2
      diabetes and whether this is associated with effects on glucose homeostasis.
    

Detailed description: 
      The aim of the study is to assess if vildagliptin and dapagliflozin have dissociated effects
      on glucagon secretion after a mixed meal ingestion in metformin-treated subjects with type 2
      diabetes and whether this is associated with effects on glucose homeostasis. Subjects will
      therefore be treated with vildagliptin or dapagliflozin as add-on to metformin for two weeks
      followed by a meal test in which glucagon levels will be determined.
    

Intervention name(s): Vildagliptin; Dapagliflozin
Intervention type(s): Drug; Drug
Intervention description(s): Vildagliptin added at 50 mg twice daily for two weeks followed by four weeks washout and then dapagliflozin 10mg once daily for two weeks; Dapagliflozin added at 10 mg once daily for two weeks followed by four weeks washout and then vildagliptin 50 mg twice daily for two weeks
Other intervention name(s): Galvus; Forxiga
Intervention MeSH terms: Dapagliflozin; Vildagliptin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Autonomic Activity During Nap Under Hypoxia
Condition: Hypoxia; Sleep; Healthy
MeSH terms: Hypoxia
Study type: Interventional

Summary: 
      Sleeping under hypoxic conditions can impair cognition and autonomic nervous activity. A
      short daytime nap can modify these changes. Here we propose a randomized, cross-over study to
      evaluate the heart rate variability during a 90 min nap in a normobaric hypoxic chamber. In
      addition, we will investigate sleep architecture, vigilance, attention and memory.
    


Intervention name(s): Normoxia; Hypoxia 1; Hypoxia 2
Intervention type(s): Other; Other; Other
Intervention description(s): Nap in hypoxia chamber at 20.9% oxygen (36 m asl); Nap in hypoxia chamber at 15.0% oxygen (simulates 2660 m asl); Nap in hypoxia chamber at 12.8% oxygen (simulates 4000 m asl)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Hypoxia; Sleep; Heart rate variability; Sleep architecture
Gum Chewing After Gynecologic Laparoscopy
Condition: Postoperative Care
Study type: Interventional

Summary: 
      Gum chewing has been reported to stimulate bowel motility after open surgery, such as
      cesarean section and other abdominal surgeries. In general, after laparoscopic surgery
      problems with reduced bowel motility are not as common as after open surgery. In this study
      the investigators test the hypothesis that gum chewing is enhancing rapid return of bowel
      motility after gynecologic laparoscopic surgery. Further the investigators study patient
      satisfaction and potential side effects of postoperative gum chewing.
    


Intervention name(s): gum chewing
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Assesment of Complications and Surgery Timing in Postcovid Thoracotomy Patients: Single Center Experience
Condition: Thoracotomy
Study type: Observational

Summary: 
      Covid-19 infection has caused delay in many surgeries. Besides Covid -19 infection may be a
      potential problem in especially major surgeries such as thoracotomies. Surgery timing,
      complications, intensive care unit stay and vaccination status are important issues that
      should be learned from post-covid cases.The aim of the study is to learn lessons from
      post-covid thoracotomy cases.
    

Detailed description: 
      Patients who had covid-19 infection before thoracotomy were assessed by their datas,
      Postoperative complications, intensive care unit stay, vaccine status, time period between
      covid infection and surgery were collected from patients' files and statistical analysis
      performed.
    

Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        post-covid patients undergoing thoracotomy
      
Keywords: Thoracotomy; covid infection; complication
Comparison of Two Meningococcal ACWY Conjugate Vaccines
Condition: Meningococcal Meningitis
MeSH terms: Meningitis, Meningococcal; Meningitis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      There is evidence of waning immunity in individuals vaccinated against meningitis C as part
      of the UK infant immunisation schedule. The intention of this study is to contact
      participants of a previous NVEC (National Vaccine Evalutaion Consortium) clinical trial (a
      PreSchool Men C trial, in which participants were randomised to receive Meningitec, Menjugate
      or Neisvac-C). They will be invited to enrol and will be randomised to receive one of two
      quadrivalent meningococcal ACWY vaccines, to look at the boosting effect they may confer.
    

Detailed description: 
      Between 550 and 650 subjects enrolled in a previous Meningococcal C vaccine study will be
      invited to join this new study looking at the boosting effects of two quadrivalent
      meningococcal ACWY vaccines. If they choose to participate, they will be randomised to
      receive one of the ACWY vaccines. Within each vaccine group, there will be further division
      into short (6 months) or longer (9 months) follow-up.

      Each participant will be given one dose of an allocated vaccine. Blood samples will be taken
      three times from each participant - the first sample will be pre-vaccination; the second
      sample will be taken one month after vaccination; and the third and final sample at either
      six or nine months after vaccination (depending on the group they are randomised to).
    

Intervention name(s): Menveo; MenACWY-TT
Intervention type(s): Biological; Biological
Intervention description(s): Single dose Menveo (a MenACWY vaccine conjugated to CRM-197).; Single dose MenACWY-TT (MenACWY vaccine conjugated to Tetanus Toxoid, TT)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Meningitis; Meningococci; Meningitis C; Meningitis A; Meningitis W135; Meningitis Y; Antibody
Automated Parkinson's Disease (PD) Motor Symptom Assessment for Deep Brain Stimulation (DBS) Programming
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Observational

Summary: 
      The purpose of this study is to evaluate the utility of a portable motion sensor-based system
      designed to assist with deep brain stimulation (DBS) programming sessions for Parkinson's
      disease patients.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Parkinson's disease
      
Keywords: deep brain stimulation; monopolar review; motion sensors; tremor; bradykinesia
Group B Streptococcus: Attitudes to Immunisation in Pregnancy
Condition: Immunisation During Pregnancy; Group B Streptococcus
Study type: Observational

Summary: 
      Group B Streptococcus (GBS) is the commonest cause of severe infection and meningitis in
      babies under 3 months in the United Kingdom (UK). About one in ten babies with GBS infection
      die and half of babies with GBS meningitis are left with long term problems with their
      development.

      Vaccinating pregnant women against GBS in order to protect their newborn babies is a
      promising area of research.However, many women are reluctant to accept vaccination during
      pregnancy for fear it will harm their unborn child and there is often a lack of understanding
      of both the vaccine and the condition it aims to prevent. Nevertheless, the recent positive
      experience of immunisation against pertussis in the United Kingdom, suggest that antenatal
      immunisation can be acceptable.

      Previous research has shown that advice from maternity healthcare professionals regarding
      vaccination is highly valued by pregnant women so it is also important to explore the
      attitudes and opinions of this group.

      The objective of this study is to assess the knowledge and attitudes of pregnant women and
      maternity healthcare professionals in England and Scotland regarding GBS disease and the
      acceptability of a potential vaccine.

      There are two parts to this study. The first part will invite pregnant women, maternity
      healthcare professionals and parents who have had a child affected by GBS disease to take
      part in either a focus group or an individual interview.

      This will allow for an in-depth exploration of the participants thoughts and opinions about
      GBS and vaccination in pregnancy. This part of the study will take place at the Oxford site
      only. The results will guide the development of a self completed, paper questionnaire which
      will be distributed to a wider range of pregnant women and maternity healthcare professionals
      across four different study sites.

      This study has been funded by Meningitis UK. Additional collaborators to those listed include
      the charity Group B Strep Support.
    


Observational model: Other
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Pregnant women aged 18 years and over of any gestation receiving antenatal care in the
        Oxford area (part one and two) or within Imperial college and St Georges's NHS trusts in
        London and Edinburgh Royal infirmary (part two).

        Maternity healthcare professionals (midwives and doctors)working in the above areas.

        Parents who have had a child with Group B streptococcal disease (part one only).
      
Keywords: Group B streptococcus; Immunisation; Pregnancy; Attitudes
Hydroxyurea in Young Children With Sickle Cell Anemia
Condition: Sickle Cell Anemia
MeSH terms: Anemia; Anemia, Sickle Cell
Study type: Interventional

Summary: 
      The purpose of this study is to asses prospectively the safety and efficacy of hydroxyurea
      therapy in children with Sickle cell Anemia between ages 18 months and 5 years, with special
      emphasis on the ability of hydroxyurea to prevent or reverse chronic organ damage.
    

Detailed description: 
      Previous studies have shown that hydroxyurea therapy in adults and older children with SCA
      improves laboratory parameters and ameliorates the clinical severity of disease. Little is
      known, however, about the effects of hydroxyurea on the chronic organ damage that occurs in
      patients with SCA and leads to significant morbidity and mortality in young adults. The
      objectives of this study are to assess the safety and efficacy of HU in young children with
      SCA and to determine whether HU preserves renal function, reduces transcranial doppler
      ultrasound (TCD) values, and prevents development of brain ischemia as evidenced by MRI/MRA
      imaging. In addition, we will evaluate the effects of hydroxyurea on quality of life
    

Intervention name(s): hydroxyurea
Intervention type(s): Drug
Intervention MeSH terms: Hydroxyurea
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: sickle cell anemia; hydroxyurea
Dexamethasone in Lower Third Molar Surgery
Condition: Impacted Third Molar Tooth
MeSH terms: Tooth, Impacted
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this randomized double-blind cross over clinical trial is to investigate
      effectiveness of different routes of applications (intramuscular and submucous at the site of
      surgery) and doses (4 mg and 8 mg) of Dexamethasone on swelling, trismus, pain and quality of
      life after lower third molar surgery.
    


Intervention name(s): Intramuscular application; Submucosal application; 4mg Dexamethasone submucosal; 8mg Dexamethasone submucosal; 4mg Dexamethasone preoperative; 4mg Dexamethasone postoperative
Intervention type(s): Procedure; Procedure; Drug; Drug; Procedure; Procedure
Intervention description(s): Patient receive 4mg of Dexamethasone by intramuscular application; Patients receive 4mg of Dexamethasone by submucosal application; Patients receive 4mg of submucosal Dexamethasone; Patients receive 8mg of submucosal Dexamethasone; Patients receive 4mg of Dexamethasone preoperatively; Patients receive 4mg of Dexamethasone postoperatively
Other intervention name(s): Dexasone; Dexasone
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; BB 1101
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Dexamethasone; Lower third molar surgery