bioihbjkbjnl/mcl2 huggingface dataset:
Anti-CMV Cellular Immunity Quantification Using an IGRA Test in Kidney Transplant récipients and Hemodialysis Patients, Comparison to Control Patients
Condition: Quantiferon-CMV; Cytomegalovirus Infections; Kidney Transplant Infection; Hemodialysis
MeSH terms: Infections; Communicable Diseases; Cytomegalovirus Infections
Study type: Observational

Summary: 
      Evaluation of anti-CMV T cellular immunity using an IGRA test (Quantiferon-CMV test) in
      kidney transplant recipients and hemodialysis patients, comparison to control patients.
    

Detailed description: 
      Cytomegalovirus (CMV) infection is a common opportunistic complication after kidney
      transplantation (KT). It has been associated with high morbidity and mortality in kidney
      transplant recipients (KTR). Its actual management is only based on the humoral immunity :
      the main risk factor for CMV infection after KT is the association of a seropositive donor
      and a seronegative recipient (so-called "D+/R- mismatch").

      However several studies have highlighted the essential role of cellular immunity to control
      CMV infection. The Quantiferon-CMV (QF-CMV) is an IGRA test (Interferon Gamma Releasing
      Assay) which evaluates T CD8 lymphocytes production of Interferon Gamma (IFNy) exposed to CMV
      antigens. Some studies have shown the possible interest of the QF-CMV in predicting CMV
      infection after antiviral prophylaxis discontinuation or when CMV viremia is detected.

      However some limits have been underlined. First its positivity threshold hasn't been approved
      in KTR. Hemodialysis patients (HP) called to receive a renal allograft also suffered from
      altered immunity. No study has directly compared the QF-CMV value in KTR, HP and control
      patients.

      That's why we propose evaluating the expression of basal cellular immunity against CMV (far
      from any active infection) in KTR and HP using the QF-CMV and comparing it to control
      patients population (not suffering from kidney dysfunction or immunosuppression).
    

Intervention name(s): Quantiferon CMV
Intervention type(s): Diagnostic Test
Intervention description(s): Evaluate and compare interferon gamma (IFNy) production by T CD8 cells exposed to CMV antigens in CMV seropositive kidney transplant recipients, hemodialysis and control patients
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Kidney transplant recipients will be recruited among KTR followed in the Kidney transplant
        department of Grenoble University Hospital.

        Hemodialysis patients will be recruited among hemodialysis patients on the waiting list for
        a kidney transplant in the Kidney transplant department of Grenoble University Hospital.

        Control patients will be recruited among non-hemodialysis and non-kidney transplanted
        patients followed in the Grenoble University Hospital.
A Study to Evaluate and Compare Injections of Autologous Mixed Population of Dermal Cells Into the Balding Scalp of Subjects With Hair Loss (CA-0005995)
Condition: Androgenetic Alopecia; Male Pattern Baldness; Female Pattern Baldness
MeSH terms: Alopecia; Alopecia Areata
Study type: Interventional
Phase: Phase 2

Summary: 
      Evaluate the ability of injections of Ji Gami(TM) CN to induce hair growth in male and female
      subjects with hair loss.
    


Intervention name(s): Autologous cultured dermal and epidermal cells
Intervention type(s): Biological
Intervention description(s): A piece of occipital scalp is taken from the subject. A mixed population of dermal cells from this tissue are expanded in culture. The cells are then harvested. These cells are then injected into the balding area of the scalp of the original subject.
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Androgenetic Alopecia; Male Pattern Baldness; Female Pattern Baldness; Hair Loss; Baldness
Evaluation of Periodontal Ligament Distraction Using a Modified Surgical Technique for Retraction of Maxillary Canines
Condition: Orthodontic Appliance Complication
Study type: Interventional

Summary: 
      Surgical modification technique try to get bodily movement during upper canine retraction.
    

Detailed description: 
      I- Original surgical technique (Liou and Huang technique, 1998) :

      On the conventional surgical side, (the control side), the intersepital bone was undermined
      by two vertical cuts on the mesio-buccal and mesio-palatal line angles of the first premolar
      socket. They were connected at the base of the socket by an oblique cut. The surgical round
      bur was held parallel to the long axis of the canine and moved buccolingually, while shaving
      the interseptal bone buccolingual (back-and-forth) shaving movements were reduced the
      thickness of the interseptal bone by approximately 1 mm

      II- Modified surgical technique:

      In the surgical modification side, (the experimental side), intra-alveolar mesio-buccal and
      mesio-palatal cuts and interseptal bone shaving were done by surgical round bur and copious
      irrigation, without the oblique cut since it was done blindly in the original surgical
      technique. A buccal semilunar flap was opened on the apical area of canine-premolar region.
      The surgical pin helped also in location of the point of initial drilling of the apical
      horizontal cut from buccal approach, when the surgical pin's socket arm rested on the depth
      of the socket, the vestibular arm marked the point of access. It also estimated mesiodeistal
      extension of the apical horizontal cut. The apical horizontal cut was started from the socket
      apex to half way of the interseptal bone mesiodistally as an extension and for the depth,
      Mallet and Chisel were used from the cortical bone to reach the mesio-palatal cut. The flap
      was sutured. This surgical modification step provided more predictability and safer surgery
      than the blind oblique cut in the original surgical technique.
    

Intervention name(s): Periodontal ligament distraction
Intervention type(s): Procedure
Intervention description(s): decrease the bony resistant during canine retration
Other intervention name(s): Acceleration of canine retraction
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Split-mouth
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: periodontal ligament; dentoalveolar; distraction; orthodontic
PEEP Levels on Intraabdominal Pressure and Hemodynamics in Critically Ill Patients
Condition: Intraabdominal Hypertension; Critically Ill; Hemodynamic Instability
MeSH terms: Intra-Abdominal Hypertension; Critical Illness
Study type: Interventional

Summary: 
      In this study, it was aimed to compare the effects of three different PEEP levels (0-4, 5-8,
      9-12 cmH2O) on intraabdominal pressure and hemodynamic parameters of patients in intensive
      care unit.
    

Detailed description: 
      Patients between 18-80 years old whom were mechanically ventilated without any spontaneous
      respiratory efforts on supine position were included into the study. Bladder pressure
      measurement as a practical and frequently preferred method was used in order to measure
      intra-abdominal pressure. 100 ml isotonic fluid was given during the measurement. Level of
      symphysis pubis was chosen for zeroing the pressure transducer to measure the intra-abdominal
      pressure.

      Three patient groups, each containing 22 cases, totally 66 patients were planned in this
      study. All patients were mechanically ventilated with various PEEP levels. The patients with
      0-4 cmH2O PEEP levels were named Group 4; the patients with 5-8 cmH2O PEEP levels were named
      Group 8; the patients with 9-12 cmH2O PEEP levels were named Group 12. The levels of
      patients' PEEP levels were arranged by the responsible intensive care physician regarding to
      the patients' clinic.

      Intraabdominal, central venous, arterial blood pressures, pulse rates, peripheric oxygen
      saturation, body temperature, instant fluid balances and amounts of urine (in ml/kg/hour
      unit) of the patients were measured on the 0. 6. 12. 18. and 24. hours and recorded.
    

Intervention name(s): Intraabdominal Pressure Measurement
Intervention type(s): Diagnostic Test
Intervention description(s): In this method, a sterile set system (AbViser- Wolfe Tory Medical, Saik Lake City, Utah, USA) was used in normal conditions. Measurements will be made in 20 ml saline was given, Pressure transducer was used as a reset point pubic symphysis and intra-abdominal pressure was measured.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Intraabdominal pressure of the patients were measured on the 0. 6. 12. 18. and 24. hours and recorded.
Masking: None (Open Label)
Primary purpose: Other
Keywords: Critically ill patients; intraabdominal pressure; hemodynamics; positive end-expiratory pressure
Uroflowmetry Results and Vitamin D Levels
Condition: Lower Urinary Tract Symptoms; Vitamin D Deficiency; Calcium Deficiency
MeSH terms: Vitamin D Deficiency; Lower Urinary Tract Symptoms
Study type: Observational [Patient Registry]

Summary: 
      The investigators aimed to evaluate the relationship between LUTS and vitamin D with
      uroflowmetry parameters in female patients. They found no relation between vitamin D levels
      and LUTS in respect to uroflowmetry. However, in low vitamin D patients, Ca is related with
      urologic problems. The investigators believe that there is a need for studies emphasizing
      serum Ca levels in addition to vitamin D levels in patients with LUTS.
    

Detailed description: 
      This retrospective cohort study included 186 female patients who admitted to LUTS.
      Demographic characteristics, medical history, calcium (Ca) and vitamin D including laboratory
      studies and uroflowmetry results as maximum urine flow rate (Qmax), average urine flow rate
      (Qav), and voided volume (V) were recorded. Patients were divided into two groups according
      to age (18-50 and ≥51) and vitamin D levels (<20 and ≥20).

      Laboratory parameters, uroflowmetry results, were compared between groups.

      The study was approved by the local ethics committee
      (approval#22/06/2018-09.29-54132726-000-14136). The study was conducted in accordance to the
      Helsinki Declaration and Good Clinical Practices Guidelines.
    

Observational model: Case-Only
Time perspective: Other
Sampling method: Probability Sample
Study population: 
        Female patients with low urinary tract symptoms.
      
Keywords: Lower Urinary Tract Symptoms; Vitamin D Deficiency; Calcium Deficiency
Effects of Pyruvate in Patients With Cardiogenic Shock and Intra-aortic Balloon Counterpulsation
Condition: Shock, Cardiogenic; Heart Failure; Acute Myocardial Infarction
MeSH terms: Myocardial Infarction; Shock, Cardiogenic; Infarction; Shock
Study type: Interventional
Phase: Phase 2

Summary: 
      Pyruvate is an intermediate of energy metabolism and was shown to possess pronounced positive
      inotropic effects in vitro and in vivo without altering myocardial oxygen consumption.
      Moreover, it was shown that the effects of beta-adrenergic stimulation were potentiated.
      Thus, it might be possible to save catecholamines in patients with severe heart failure or
      cardiogenic shock. This study was designed to test the hemodynamic effects of pyruvate
      administered into a coronary artery in addition to intra-aortic balloon pump counterpulsation
      in patients with severe heart failure or in patients with acute myocardial infarction and
      cardiogenic shock after having performed percutaneous coronary intervention. A pronounced
      improvement in hemodynamics is expected to occur.
    


Intervention name(s): Pyruvate
Intervention type(s): Drug
Intervention description(s): sodium pyruvate 300 mmol/L, 360 mL/h i.c. over 30 minutes.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pyruvic Acid; Shock, Cardiogenic; Catecholamines; Intra-Aortic Balloon Pumping; Cardiac Output; Cardiac Index; Cardiac Function
A Study of Extended-Release Hydrocodone/Acetaminophen (Vicodin CR®) in Subjects With Acute Pain Following Bunionectomy
Condition: Pain
MeSH terms: Acute Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the effectiveness (level of pain control) and safety
      of the administration of Extended-Release Hydrocodone/Acetaminophen compared to placebo over
      a 48 hour dosing period in patients who have had bunionectomy surgery and to assess the
      safety of the drug for 7 days after patients are discharged from the hospital.
    


Intervention name(s): Hydrocodone/Acetaminophen Extended-Release; Hydrocodone/Acetaminophen Extended Release; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 1 tablet q 12 hours; 2 tablets q 12 hours; 2 tablets q 12 hours
Other intervention name(s): ABT-712; hydrocodone / acetaminophen extended release; ABT-712; hydrocodone / acetaminophen extended release
Intervention MeSH terms: Acetaminophen; Acetaminophen, hydrocodone drug combination; Hydrocodone; Oxycodone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Acute pain following bunionectomy surgery
Knowledge and Behavior Toward Early Childhood Caries
Condition: Early Childhood Caries
Study type: Observational

Summary: 
      400 mothers are at least 18 years of age who have at least a child with minimum age of 6
      years or even younger will be selected from the outpatient clinics of October University for
      Modern Sciences and arts (MSA). The questionnaire will be administrated to obtain socio
      demographic information and to assess their oral health beliefs, knowledge, behaviors and the
      possible barriers for their accessing oral health care.
    


Intervention name(s): early childhood caries
Intervention type(s): Behavioral
Intervention description(s): a questionnaire evaluates the oral health beliefs, knowledge, and behaviors of a sample representing Egyptian mothers toward early childhood caries
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Mothers are at least 18 years of age who have at least a child with minimum age of 6 years
        or even younger will be selected from the outpatient clinics of October University for
        Modern Sciences and arts, Cairo city, the capital of Egypt.
      
Keywords: knowledge; behaviors; Early childhood caries
A Study of LY3372993 in Healthy Participants and Participants With Alzheimer's Disease (AD)
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to evaluate the safety and tolerability of LY3372993 in
      healthy participants and participants with AD. The study will also investigate how much
      LY3372993 gets into the bloodstream and test the effects of LY3372993 in participants with
      AD.

      The study has two parts:

        -  Part A - Healthy participants will receive LY3372993 or placebo. Part A will last up to
           17 weeks;

        -  Part B - Participants with AD will receive LY3372993 or placebo. Part B will last about
           317 days.
    

Detailed description: 
      In April, 2019, Eli Lilly and Company made a business decision to terminate Part B. No
      participants were enrolled.
    

Intervention name(s): LY3372993; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered IV.; Administered IV.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Alternative Options to Minimize Niacin-Induced Flushing
Condition: Hypercholesterolemia; Flushing
MeSH terms: Hypercholesterolemia; Flushing
Study type: Interventional

Summary: 
      Niacin (Vitamin B3) is known to effectively and safely treat hypercholesterolemia. However,
      use of niacin is limited due to incidents of flushing which limits its acceptability. Some
      information suggests that applesauce can reduce the incidence and severity of flushing. The
      apple pectin in particular is thought to be the ingredient that affects this reaction. To
      determine if the apple pectin does affect flushing from niacin, the investigators will study
      the affects of isolated apple pectin in pill form. The investigators plan on recruiting 100
      patients, and giving them 1000 mg of Niacin to induce flushing. Patients will be divided into
      4 treatment groups and receive either pectin, aspirin, a combination of both, or placebo.
      Incidents and severity of flushing will be monitored for up to 6 hours post Niacin ingestion.
    


Intervention name(s): Apple pectin; Aspirin 325 mg; Placebo
Intervention type(s): Other; Drug; Other
Intervention description(s): Apple pectin 2000mg; Aspirin 325 mg; Placebo
Intervention MeSH terms: Aspirin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: Niacin; Hypercholesterolemia; Flushing
Effect of Apples on cardioVascular Risk And Gut Health
Condition: Mild Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional

Summary: 
      There is now considerable scientific evidence that a diet rich in fruits and vegetables could
      improve human health. Apples are among the most frequently consumed fruits in the world.
      Epidemiological studies have linked frequent apple consumption with several health benefits
      including a reduced risk of cardiovascular disease. Apples are an important source of
      polyphenols and fiber and their beneficial effects could be attributed to this content;
      however, their impact on our health is not clear. Although, there are some studies that have
      reported cholesterol lowering effects the results are inconsistent. Furthermore, few studies
      have explored the impact on vascular function and gut microbiota. The objective of the
      current study is to assess whether a regular apple consumption, reduces total cholesterol
      levels, improves vascular function and gut microbiota profile in mildly hypercholesterolemic
      subjects compared with a control, sugar matched commercial clear apple juice squash.
    


Intervention name(s): whole apples (WA); apple juice (AJ)
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Bioequivalence of Amphotericin B Liposome for Injection
Condition: Bioequivalence
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to evaluate the bioequivalence of two different
      amphotericin B liposome for injection after single IV infusion at the same dose in normal
      healthy subjects.
    

Detailed description: 
      Single-Center, Open-Label, Randomized, Two-treatment, Crossover, Two-sequence, Single-Dose
      Bioequivalence study of Amphotericin B Liposome for Injection and AmBisome (Amphotericin B)
      Liposome for Injection in healthy subjects.
    

Intervention name(s): Amphotericin B liposome for injection; AmBisome
Intervention type(s): Drug; Drug
Intervention description(s): IV infusion, 2.0 mg/kg; IV infusion, 2.0 mg/kg
Other intervention name(s): the test product; the reference product
Intervention MeSH terms: Amphotericin B; Liposomal amphotericin B
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Acceptance-Based Treatment for Prostate Cancer Distress
Condition: Early Stage Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional

Summary: 
      Prostate cancer (PCa) is the most common type of cancer in men and the second leading cause
      of death in American men. Those diagnosed with localized prostate cancer encounter three
      sources of psychological distress: 1) diagnosis itself, 2) treatment decision making, and 3)
      the often life-altering side effects of treatment. In addition, patients who choose to
      undergo active surveillance which focuses on monitoring cancer in lieu of treatment,
      experience distress related to living with cancer. Acceptance and Commitment Therapy (ACT) is
      an established psychosocial intervention that has been used extensively for mental health
      treatment and has shown benefits for various chronic conditions. ACT is a behavioral
      intervention that focuses on tolerating distress and improving function. This pilot study is
      designed to test the feasibility of ACT for distress reduction and improved quality of life
      in patients recently diagnosed with early-stage, localized PCa.
    


Intervention name(s): Acceptance and Commitment Therapy
Intervention type(s): Behavioral
Intervention description(s): group-based behavioral workshop to address cancer-related distress
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: prostate cancer; behavioral; acceptance and commitment therapy; distress
Study Evaluating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PRA-027 in Japanese Postmenopausal Women
Condition: Uterine Leiomyomata (Fibroids)
MeSH terms: Leiomyoma; Myofibroma
Study type: Observational

Summary: 
      The primary purpose of this study is to assess the safety and tolerability of ascending,
      multiple, oral doses of PRA-027 in Japanese postmenopausal women. The secondary purpose is to
      evaluate the PK and PD profile of multiple oral doses of PRA-027 in Japanese postmenopausal
      women.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        community sample
      
Biospecimen description: 
      whole blood
BPA Levels Relationship With IVF/ICSI Outcomes in Low Ovarian Reserve
Condition: Infertility Low Over Reserve; IVF; Infertility, Female
MeSH terms: Infertility; Infertility, Female
Study type: Interventional

Summary: 
      The relationship between BPA elevation in urine, blood, and follicle fluid and embryo
      quality, IVF/ICSI outcomes.
    


Intervention name(s): BPA levels
Intervention type(s): Other
Intervention description(s): BPA (bisphenol A) in urine, blood and follicle fluid samples
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care