bioihbjkbjnl/mcl2 huggingface dataset:
Bone Marrow Mononuclear Cells vs Mesenchymal Stem Cells in Diabetic Patients With Chronic Limb Ischemia
Condition: Chronic Limb-threatening Ischemia; Diabetes Mellitus
MeSH terms: Chronic Limb-Threatening Ischemia; Ischemia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Patients in the severe stages of Chronic limb-threatening ischemia (CLTI) are prone to
      amputation and death, leading to poor quality of life and a great socioeconomic burden.

      There is an urgent need to develop an effective therapeutic strategy to treat this disease.
      In this context, autologous bone marrow mononuclear cells (BM-MNC) and allogeneic mesenchymal
      stem cells derived from different sources have emerged as promising therapeutic approaches
      for this condition.
    

Detailed description: 
      Comparison of the therapeutic potential of BM-MNC vs. allogeneic Wharton jelly-derived
      mesenchymal stem cells (allo-WJ-MSCs) in diabetic patients with CLTI.

      Twenty-four type 2 diabetic patients in the most severe stages of the CLTI (category 4 or 5
      in Rutherford's classification and transcutaneous oxygen pressure (TcPO2) below 30 mm Hg were
      enrolled and randomized to receive 15 injections of (i) BM-MNC (7.197x106 ± 2.984 x106
      cells/mL each with 2% of autologous serum) (n=7), (ii) allo-WJ-MSCs (1.333 x106 cells/mL each
      with 5% of human serum albumin serum) (n=7) or (iii) placebo solution (1 mL saline solution
      with 2% of autologous serum) (n=10), which were administered into the periadventitial
      arteries.

      The follow-up visits were at months 1, 3, 6, and 12, to evaluate the following parameters:

      (i) Rutherford classification (0 to 6) (ii) TcPO2 (mmHg) (iii) Wound closure (area cm2) (iv)
      pain (visual analogue scale (0-10) (v) pain-free walking distance (m) (vi) revascularization
      and limb-survival proportion during follow-up (vii) the quality of life (EQ-5D
      questionnaire).
    

Intervention name(s): Cell-based therapy
Intervention type(s): Biological
Intervention description(s): One dose of auto-BM-MNC, one dose of allo-WJ-MSCs, or one dose of placebo solution (saline solution with 2% of autologous serum), were periadventitial arteries administration in CTLI patients.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Bone marrow mononuclear cells; Mesenchymal stem cells
Diagnosis and Staging of Neuroendocrine Tumors (NETs) Utilizing 68Ga-DOTATOC PET/CT Scan
Condition: Neuroendocrine Tumors
MeSH terms: Neuroendocrine Tumors
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary goal of the analysis is to estimate the diagnostic accuracy of Gallium 68 (68Ga)
      -DOTATOC PET/CT for detecting neuroendocrine tumors (NETs) compared to conventional imaging
      techniques such as Magnetic Resonance Imaging (MRI) and Computerized Tomography (CT).
      Participants with histologically and/or clinically confirmed and/or suspected NET will be
      enrolled.
    

Detailed description: 
      This is a prospective, Phase 2, single center study of participants with Neuroendocrine
      Tumors (NETs). Study participants will receive 68Ga-DOTATOC. DOTATOC is a somatostatin
      analogue that localizes on the somatostatin receptors expressed by NETs and is attached to a
      radioactive material called Gallium 68. Participants will undergo a PET/CT imaging study to
      investigate 68Ga-DOTATOC's suitability as a positron emission tomography (PET) imaging agent
      for NETs. The radiation (imaging) dose will be 111-185 megabecquerel (MBq) (3 - 5 mCi) ± 25%.
      All doses after labeling will be presented in buffered solution for intravenous injection.
      Imaging will start 90 ±30 minutes after injection.

      Sensitivity and specificity of this imaging technique will be compared with those of
      conventional imaging modality including CT, MRI and In-111 Octreoscan performed within 6-12
      months before or after PET/CT.
    

Intervention name(s): 68Ga-DOTATOC
Intervention type(s): Drug
Intervention description(s): The intervention is to administer 68Ga-DOTATOC PET/CT for detecting NET.
Other intervention name(s): Diagnostic test
Intervention MeSH terms: Edotreotide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
The Effect of Handgrip Strength on Functional Level
Condition: Rehabilitation
Study type: Interventional

Summary: 
      In this study, it was aimed to examine the effects of kinesio tape applied to the forearm
      extensor muscles on the functional level of patients undergoing lower extremity surgery with
      walker ambulation.

      Patients who were evaluated before being included in the post-surgical rehabilitation program
      (before kinesio tape application) and before discharge will be included in the study group.
      For the control group data, patients who underwent lower extremity surgery at the same
      institution for similar periods, but were included in the standard rehabilitation program,
      but did not apply kinesio tape, will be included. Standard rehabilitation practice includes
      in-bed transfer training, gait training, practice of daily living activities, and therapeutic
      exercise practices .

      Before the standard rehabilitation program, kinesio taping was applied to both upper
      extremities in the form of a "Y" tape from the medial epicondyle to the wrist flexors, with
      15-20% tension, to the patients hospitalized in the orthopedic service after lower extremity
      surgery. The tape should remain on the patient's arm throughout the hospital stay
    

Detailed description: 
      In the literature, as predictors of poor functional recovery after lower extremity fracture
      and prosthetic surgery; old age, low functional level before fracture, cognitive impairment,
      comorbidities, living alone, and long hospital stay have been shown. Although the lower
      extremity has a higher relationship than the upper extremity in activities such as walking
      and physical function, the grip strength, which is closely related to the lower extremity
      strength, is an easily measurable, reliable, and applicable method for assessing whole body
      strength.In addition, handgrip strength is used as an important criterion in determining the
      functional level of elderly individuals. Although there are many studies in the literature
      that grip strength is a determinant of functional level, no study has been encountered
      showing the effects of kinesio taping application on the functional level of improving grip
      strength in elderly individuals who have undergone lower extremity surgery and provided with
      walker assisted ambulation.
    

Intervention name(s): kinesio tape application
Intervention type(s): Other
Intervention description(s): Before the standard rehabilitation program, kinesio taping was applied to both upper extremities in the form of a "Y" tape from the medial epicondyle to the wrist flexors, with 15-20% tension, to the patients hospitalized in the orthopedic service after lower extremity surgery. The tape should remain on the patient's arm throughout the hospital stay
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Elderly; Functional Level; Handgrip Strenght; Kinesio Tape
The Effect of Ketamine on Attentiveness
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to develop an exploratory design for future Proof-of-Concept
      trials which reliably and accurately measure the central nervous system (CNS) effects of
      potentially new drugs that oppose the effects of ketamine at a subanesthetic dose level given
      to healthy volunteers. A functional magnetic resonance imaging (fMRI) and
      electroencephalogram (EEG) performed simultaneously during a ketamine challenge will register
      the effects triggered by Ketamine.
    

Detailed description: 
      This will be a double-blind (neither physician nor patient knows the name of the assigned
      drug), placebo-controlled, randomized (study drug assigned by chance), 2 way crossover
      ketamine challenge study (participants may receive different interventions sequentially
      during the trial) in 24 healthy male volunteers. For all participants, this study will
      consist of an eligibility screening examination, two 2-day treatment periods, separated by at
      least 1 week, and a follow-up examination about 7 days after last dose administration. The
      maximal study participation for each volunteer will be around 6 weeks. Apart from observing
      possible neural and vascular ketamine effects, the cerebral ketamine effects will be
      investigated by simultaneously performing fMRI/EEG during ketamine administration. These
      investigations will be done while volunteers rest as well as during cognitive testing (visual
      oddball task). Safety evaluations include continuous monitoring of vital signs and oxygen
      saturation. Due to the pharmacokinetic properties of ketamine the assessments will start
      after an intravenous ketamine bolus (drug given directly into the vein over a short period of
      time) followed by a 1 minute break. During the assessments there is a continuous intravenous
      (minimal) drug administration. Before the assessments start there will be an intravenous
      bolus of 0.1 mg/kg ketamine in 5 minutes time followed by a 1 minute break after which a
      continuous infusion will start of 0.015625 mg/kg/min ketamine. Since the plasma level
      elevates during the infusion the administered dose will be lowered by 10% every 10 minutes.
    

Intervention name(s): Placebo; ketamine
Intervention type(s): Drug; Drug
Intervention description(s): An intravenous bolus will be given in 5 minutes time followed by a 1 minute break after which a continuous infusion will start. Dosage lowered every 10 minutes; An intravenous bolus of 0.1 mg/kg will be given in 5 minutes followed by a 1 minute break after which a continuous infusion will start at 0.015625 mg/kg/min.
Intervention MeSH terms: Ketamine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Ketamine
Non-interventional Study on TEAM Conditioning in Patients With Lymphoma (TEAM)
Condition: Lymphoma
MeSH terms: Lymphoma
Study type: Observational

Summary: 
      Lymphoma is a malignant blood disease sensitive to chemotherapy. In case of relapse after
      first-line treatment, high-dose chemotherapy conditioning followed by autologous
      hematopoietic stem cell transplantation (auto-HSCT) improves patient survival and reduces the
      risk of relapse. Auto-HSCT may also be indicated in the first line in case of aggressive
      lymphoma at high risk of relapse. BEAM (Carmustine, Etoposide, Aracytine and Melphalan) is
      the more frequently used high-dose conditioning regimen. Nevertheless, Carmustine is no
      longer available in Europe.

      The investigators have therefore chosen to replace Carmustine by Thiotepa and use the TEAM
      regimen as the new conditioning. Indeed, Thiotepa is approved by french national agency for
      the security of drugs (ANSM) for use as part of auto-HSCT conditioning regimen. The results
      of TEAM regimen in terms of efficacy and toxicity appear similar to those of BEAM. However,
      no study have been performed prospectively. Only small series and case reports have been
      reported.

      If the study confirms the results of retrospective studies, conditioning by TEAM could become
      a new standard in auto-HSCT for the treatment of lymphoma.

      This study is non-interventional, prospective with 3 centers.

      All included patients will receive, according to standard practice and drug label in France,
      the following diagram:

        1. Conditioning:

             -  Thiotepa 8 mg / kg to J-6

             -  Etoposide 100 mg / m² / 12 h for 4 days (J-5 to D-2)

             -  Aracytine 200 mg / m² / 12 h for 4 days (J-5 to D-2)

             -  Melphalan 140 mg / m² on day-1

        2. Transfusion graft: the day D0 with autologous peripheral stem cell transplant

        3. Care supports: Patients will be treated according to the usual procedures of centers
           participating in the study at the discretion of the investigator.

        4. Follow-up of patients will not be changed by the study.

      The main objective of the study is to evaluate the progression-free survival (PFS) of
      lymphoma patients treated with autologous stem cells after conditioning by TEAM

      Secondary objectives are:

        -  To evaluate overall survival;

        -  To assess the response to treatment;

        -  to evaluate the incidence of relapse;

        -  to assess the toxic transplant related mortality;

        -  to study transplant-related morbidity (infections, nutritional and gastrointestinal
           toxicity, immune reconstitution).
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Lymphoma patients will be recruited in on the French site
      
Keywords: Lymphoma; TEAM conditioning; autologous stem cells transplantation
Evaluation of Tolerance and Trichological Efficacy of a Food Supplement
Condition: Telogen Effluvium
Study type: Interventional

Summary: 
      Controlled, randomized, double blind study, for the evaluation of tolerance and trichological
      efficacy of a food supplement: Bioscalin® new formulation versus reference formulation
      currently on the market and placebo
    

Detailed description: 
      Aim of the study was to evaluate clinically and by non-invasive instrumental measurements the
      trichological activity of a food supplement taken for 3 months by subjects of both sexes,
      aged between 18-60 years, affected by telogen effluvium, with a percentage of hair in anagen
      phase < 75%.

      In particular the study foresaw the evaluation of the trichological activity of the
      Bioscalin® new formulation with Galeopsis Segetum in comparison to a reference product
      currently on the market and to placebo.

      It was also aim of this study to evaluate treatment tolerance.
    

Intervention name(s): Bioscalin® new formulation with Galeopsis Segetum; Reference product; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Total duration of the study was 4 months; each subject, took by mouth two capsules/die of placebo at breakfast and one tablet/die of study product at lunch for the first 3 months of the trial.; Total duration of the study was 4 months; each subject, took by mouth two capsules/die of reference product at breakfast and one tablet/die of placebo at lunch for the first 3 months of the trial.; Total duration of the study was 4 months; each subject, took by mouth two capsules/die of placebo at breakfast and one tablet/die of placebo at lunch for the first 3 months of the trial.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Sperm Pathology Samples and Morphokinetics
Condition: Cylinical Embryo; Oligospermia
MeSH terms: Oligospermia
Study type: Observational

Summary: 
      The embryo kinetics may be a new prognostic factor for choosing the embryos with the highest
      implantation potential. In order to identify the factors that may affect the rate of embryo
      cleavage, there are many studies about morphokinetics and culture medium, oxygen tension,
      oocyte quality or type of medication used for ovarian stimulation. However there are no
      published data with respect to the influence of semen quality in the embryo kinetic.

      In this study The investigators propose that the sperm quality may has influence in the
      embryo division.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Sperms samples of assisted reproduction treatments
Comparison of Ventilation With Bag-Valve-Mask, Laryngeal Tube S-D and Laryngeal Mask Airway Supreme
Condition: Cardiopulmonary Arrest
MeSH terms: Heart Arrest
Study type: Interventional

Summary: 
      Inexperienced rescuers may encounter severe problems in an unconscious patient in opening and
      maintaining an upper airway patent. Gaining evidence which ventilation technique may be most
      efficient and safe is of utmost importance to potentially improve outcome during
      cardiopulmonary resuscitation.
    

Detailed description: 
      During cardiopulmonary resuscitation (CPR) ventilation has to be efficient to provide oxygen
      to the body and safe to avoid potentially fatal regurgitation and aspiration pneumonia and
      excessive stomach inflation. Basically trained rescuers have severe problems to ventilate a
      patient during cardiopulmonary resuscitation. This study intends to compare three commonly
      employed ventilation techniques. First, the traditionally bag-valve mask ventilation is
      commonly taught during CPR course, despite recent evidence suggesting low efficiency rates.
      Second, the laryngeal mask and the laryngeal tube supraglottic airways have shown high
      efficiency and safety in previous studies in the hand of experienced clinicians. Until now it
      is unclear if basically trained rescuers are better in ventilation with bag valve mask
      ventilation or the supraglottic airway devices, the laryngeal mask and the laryngeal tube.
      The purpose of this study is to compare in anesthetised patients airway management and
      ventilation with bag-valve mask, laryngeal mask and laryngeal tube.
    

Intervention name(s): Bag-Valve-Mask-Ventilation (Ambu Facemask); Laryngeal Mask (Laryngeal Mask Airway Supreme); Laryngeal Tube (Laryngeal Tube LT-S-D (VBM))
Intervention type(s): Device; Device; Device
Intervention description(s): Bag-Valve Mask-Ventilation; Ventilation; Ventilation
Other intervention name(s): Ambu Facemask; Laryngeal Mask Airway Supreme; Laryngeal Tube LT-S-D (VBM)
Intervention MeSH terms: Chlorhexidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Airway; Bag-Valve -Mask- Ventilation; Laryngeal Mask - Ventilation; Laryngeal Tube - Ventilation
Opioid Treatment for Chronic Low Back Pain and the Impact of Mood Symptoms
Condition: Chronic Low Back Pain; Degenerative Disc Disease; Depression; Anxiety
MeSH terms: Intervertebral Disc Degeneration; Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      Opioids are frequently prescribed for chronic low back pain (CLBP). Psychiatric illness, such
      as high levels of depression and anxiety symptoms, is a common co-occurrence in chronic pain
      patients (and is termed comorbid negative affect [NA]). The purpose of the study is to
      determine whether CLBP patients with either a high vs. a low or moderate degree of NA have
      different pain relief responses to oral opioids.
    

Detailed description: 
      The level of high, moderate or low NA was determined based on the participant's score on the
      Hospital Anxiety and Depression Scale (HADS). The HADS is a self-reported questionnaire that
      has 14 questions related to 2 domains: Anxiety subscale (7 questions) and Depression subscale
      (7 questions). Each item on the questionnaire is scored from 0 (least amount of
      anxiety/depression) to 3 (greatest amount of anxiety/depression), with total score between 0
      and 21 for either anxiety or depression. Participants were assigned to high, moderate or low
      NA groups using the following HADS score criteria:

        -  High NA = HADS score ≥9 on each subscale

        -  Moderate NA = HADS score ≥6 to ≤8 on each subscale

        -  Low NA = HADS score ≤5 on each subscale
    

Intervention name(s): Oxycodone; Morphine; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Daily dosage up to 120 mg; Daily dosage up to 90 mg immediate release or 180 mg extended release; Placebo-matching oxycodone, placebo-matching morphine
Other intervention name(s): Morphine sulfate (MS) Contin; Morphine sulfate instant release (MSIR); Morphine sulfate extended release (MSER)
Intervention MeSH terms: Morphine; Oxycodone
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: low back pain; opioids; mood symptoms
Investigation of Brain Nitrogen in Partial Ornithine Transcarbamylase Deficiency (OTCD) Using 1 H MRS, DTI, and fMRI
Condition: Ornithine Transcarbamylase Deficiency
MeSH terms: Ornithine Carbamoyltransferase Deficiency Disease
Study type: Observational

Summary: 
      The purpose of this study is to use various types of MRI and cognitive testing to evaluate
      changes in the brain and cognitive function that occur in subjects with ornithine
      transcarbamylase deficiency (OTCD) relative to healthy individuals
    

Detailed description: 
      The overall goal of this project is to characterize metabolic, structural and cognitive
      changes in OTCD using 1H MRS, DTI, volumetric averaging and fMRI with cognitive testing of
      executive function measures to validate biomarkers for the effect of HA and its treatment on
      the brain.

      The investigators will measure gln and mI in blood and brain (using 1H MRS) in affected
      participants, and mI in brain in controls, fractional anisotropy as a measure of white matter
      microstructural damage (by DTI) and brain activation pathways alterations with tasks probing
      working memory (fMRI). As a secondary outcome measure, the investigators will correlate the
      findings from neuroimaging with cognitive functioning. This protocol is based on the previous
      5104 protocol, now includes children to evaluate the age and stage of disease on these
      indices in a cohort that is undergoing important developmental events against an age matched
      typically developing cohort.
    

Intervention name(s): MRI scanning; Cognitive testing
Intervention type(s): Other; Behavioral
Intervention description(s): 1H MRS, DTI, FMRI; Behavioral testing
Other intervention name(s): MRI
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Males and females, ages 7-60 years with ornithine transcarbamylase deficiency Males and
        females, ages 7-60 years who are healthy controls without ornithine transcarbamylase
        deficiency
      
Keywords: Neuroimaging; MRI; Urea cycle; hyperammonemia; cognitive function; ornithine transcarbamylase deficiency