bioihbjkbjnl/mcl2 huggingface dataset:
Serum Sclerostin Level & Treatment of Vitamin D Deficiency
Condition: Endocrine System Diseases; Vitamin D Deficiency
MeSH terms: Vitamin D Deficiency; Endocrine System Diseases
Study type: Observational

Summary: 
      The aim of this study is to determine serum sclerostin levels and change in serum sclerostin
      levels in patients with Vitamin D deficiency treated with calcium and vitamin D.

      Healthy premenopausal Patients with Vitamin D deficiency diagnosed and routinely treated with
      calcium and vitamin D will be included in the study. This is an observational study. The
      serum sclerostin levels will be measured before and after Vitamin D treatment.
    

Detailed description: 
      This study is a prospective, observational, single-center study. Ethical approval was
      obtained from the Institutional Review Board.

      This study will be completed with patients with Vitamin D deficiency. An intravenous cannula
      will be inserted into the antecubital vein. Blood samples will be obtained before and after
      treatment.

      Serum will be collected and will be centrifuged for 15 minutes at 1000Xg within 30 minutes of
      collection. Aliquots of serum will be added to eppendorf tubes and stored at -20°C.

      Serum sclerostin levels will be measured using a Human Sclerostin ELISA kit (Cusabio, Catalog
      No: CSB-E13146h, Newark, DE, USA). All assays will be performed according to the
      manufacturer's instructions. The minimum detectable concentration of human sclerostin is
      typically <0.012 ng/ml. Intra-assay precision is less than 8%.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with vitamin D deficiency
      
Keywords: sclerostin; osteomalacia; vitamin D deficiency
Medico-economic Evaluation of Subcutaneous Automatic Resorbable Staples Device
Condition: ENT Surgery; Gynecological Surgery; Plastic Surgery
Study type: Interventional
Phase: Phase 3

Summary: 
      A surgery made by an external incision requires to stitch the subcutaneous plans, usually
      performed using absorbable synthetic sutures hold on wire needle. This national, prospective,
      multicentric, and randomized study is devoted to estimate a technique of suture of the
      subcutaneous plans based on an implantable medical device delivering automatically absorbable
      staples. This particularly innovative technique lets to expect a tolerance and an efficiency
      at least equivalent to the reference technique (main objective). Moreover, this technique
      allows to anticipate a reduction of the duration of surgical procedure and anesthetic time
      while limiting the risks of blood wounds of the medical staff.The medical economic part of
      this study will check, from the point of view of the health care hospital, wether the
      technique is likely to reduce the costs and time consuming theater room procedures.
    


Intervention name(s): Insorb resorbable staples; Monocryl resorbable wire
Intervention type(s): Device; Device
Intervention description(s): Subcutanous suture using resorbable staples; Subcutanous suture using resorbable wire
Other intervention name(s): Insorb staples; Monocryl Wire
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Subcutaneous resorbable sutures; Tolerance / effectiveness of subcutaneous suture; Reduced operative time and anesthesia time; Medico-economic evaluation; Accidental exposure to blood
Double-blind Placebo Controlled Study of Oxytocin in Fragile X Syndrome
Condition: Fragile X Syndrome
MeSH terms: Fragile X Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether the medication oxytocin is an effective and
      tolerable treatment in adolescent males with fragile X syndrome (FraX) for improving socially
      appropriate behaviors and reducing social anxiety.
    

Detailed description: 
      Twelve male adolescent (13-24 years) subjects with confirmed genetic diagnosis of FraX (full
      mutation) will participate in this randomized double-blind placebo-controlled study. They
      will receive a dose of either 24 IU oxytocin, 48 IU oxytocin or placebo at each of three
      visits to the lab, with each visit spaced one week apart. The efficacy of each dose will be
      evaluated using behavioral, cognitive and physiological metrics. If individual subject
      results suggest that either of the oxytocin dosage levels (24 IU or 48 IU) is superior to
      placebo in the double-blind phase, a single-blind trial using the optimal dosage of oxytocin
      will then be administered daily for 14 days by parents at home. Subjects will then come into
      the lab for a final assessment on Day 30. Determination of beneficial response to oxytocin
      will be based on a 20% change (improvement) in behavior or test performance (see below). If
      both oxytocin dosage levels provide similar benefits compared to placebo, the lower dose will
      be chosen for the 14 day single-blind trial.
    

Intervention name(s): placebo; oxytocin 24IU; oxytocin 48IU
Intervention type(s): Drug; Drug; Drug
Intervention description(s): intranasal placebo (48 international units); intranasal oxytocin (24 international units) and intranasal placebo (24 international units); intranasal oxytocin (48 international units)
Other intervention name(s): Syntocinon; Syntocinon
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Safety and Pharmacokinetics of Carbavance™ (RPX2014/RPX7009) in Subjects With Renal Insufficiency
Condition: Subjects With Varying Degrees of Renal Insufficiency and; Subjects With Normal Renal Function
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      RPX7009(beta-lactamase inhibitor) is being studied in combination with carbapenem (RPX2014)to
      treat bacterial infections, including those due to multi-drug resistant bacteria.
    

Detailed description: 
      The worldwide spread of resistance to antibiotics among Gram-negative bacteria, particularly
      members of the ESKAPE group of pathogens, has resulted in a crisis in the treatment of
      hospital acquired infections. In particular, the recent dissemination of a serine
      carbapenemase (e.g., KPC) in Enterobacteriaceae in US hospitals now poses a considerable
      threat to the carbapenems and other members of the beta-lactam class of antimicrobial agents.

      Rempex is developing a fixed combination antibiotic of a carbapenem (RPX2014) plus a new
      beta-lactamase inhibitor (RPX7009) which has activity against serine beta-lactamases,
      including KPC. This Phase 1 study will assess the safety, tolerability and pharmacokinetics
      of intravenous RPX2014 and RPX7009, administered in combination in subjects with varying
      degrees of renal insufficiency.
    

Intervention name(s): RPX7009 and RPX2014
Intervention type(s): Drug
Intervention description(s): The study is designed to enroll approximately 32 subjects. There will be approximately 24 subjects with varying degrees of renal insufficiency and approximately 8 subjects with normal renal function.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Debate on Progesterone Elevation on the Day of Triggering
Condition: Progesterone; ART; Female Infertility; Embryo Transfer
MeSH terms: Infertility; Infertility, Female
Study type: Observational

Summary: 
      The association between serum progesterone (P) levels, measured on the day of ovulation
      trigger, and the outcome of in vitro fertilization cycles, has been one of the major
      controversies in the field of ovarian stimulation endocrinology.

      This is a single-center retrospective cohort study. Study duration period is from January
      2012 to December 2016.

      All fresh embryo transfer (ET) both at cleavage stage and blastocyst stage, performed in
      Humanitas Fertility Center during the study period, were included.
    


Intervention name(s): embryo transfer
Intervention type(s): Other
Intervention description(s): Step of the assisted reproduction in which embryos are placed into the uterus in order to obtain a pregnancy
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        All fresh embryo transfers both at cleavage stage (Day 2 and Day3) and blastocyst stage
        (Day 5), and all thawed embryo transfer, except from the ones deriving from PGTA, performed
        from January 2012 to December 2016 in Humanitas Fertility Center were included.
A High Resolution Pharmacokinetic/Pharmacodynamic Model of Propofol in Morbidly Obese Subjects
Condition: Morbid Obesity
MeSH terms: Obesity, Morbid
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will determine how morbid obesity affects the distribution and metabolism of the
      drug propofol. The investigators hypothesize that propofol will be distributed and
      metabolized differently in morbidly obese subjects as compared to normal weight subjects.
    


Intervention name(s): propofol
Intervention type(s): Drug
Intervention description(s): Morbidly obese subjects (body mass index greater than 40)and control subjects (body mass index 20-25) will be given propofol for induction of general anesthesia. Plasma samples will be taken to ascertain drug concentration over time.
Intervention MeSH terms: Propofol
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Pharmacokinetics; Pharmacodynamics
G-CSF Moblized Peripheral Harvest for Poor Engraftment After Stem Cell Transplantation
Condition: Poor Graft Function; Stem Cell Transplantation; Graft Versus Host Disease
MeSH terms: Graft vs Host Disease
Study type: Interventional

Summary: 
      Poor graft function (PGF) is a common complication after allogeneic stem cell
      transplantation, which was associated with high mortality. The pathogenesis fo PGF was poorly
      understood. Infusion of donor peripheral cell harvest was effective for some patients with
      PGF in our preliminary study. This present study aimed to explore the efficacy of peripheral
      cell harvest for poor graft function.
    

Detailed description: 
      Poor graft function (PGF) is a common complication after allogeneic stem cell
      transplantation, which was associated with high mortality. The pathogenesis fo PGF was poorly
      understood. Infusion of donor peripheral cell harvest was effective for some patients with
      PGF in our preliminary study.The peripheral cell harvest was aphaeresis on the fourth or
      fifth day after mobilization with recombinant human granulocyte colony stimulating factor.
      Hematogical response was assessed at 30 days after infusion. Good response was defined as
      neutrophil > 1.0×109/l without G-CSF support for at least 3 consecutive days, and persistent
      platelet >20×109/l without transfusion for at least 7 days. Otherwise, poor response was
      defined.
    

Intervention name(s): infusion of G-CSF mobilized peripheral harvest
Intervention type(s): Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Estimation of Osteoporosis' Prevalence in France: Pilot Study in the Department of the Alpes-Maritimes
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional

Summary: 
      The purpose of this study is to estimate Osteoporosis' prevalence in France and is a pilot
      study in the Department of the Alpes-Maritimes.
    


Intervention name(s): bone densitometry
Intervention type(s): Procedure
Intervention description(s): All patients do a bone densitometry after the inclusion.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: osteoporosis
A Study of ABT-384 Levels and Pharmacodynamic Activity Measured in Cerebrospinal Fluid
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objectives of this study are to assess the cerebral spinal fluid (CSF) pharmacokinetics
      and the plasma/CSF pharmacokinetic/pharmacodynamic relationship of ABT-384 in healthy male
      volunteers.
    


Intervention name(s): ABT-384
Intervention type(s): Drug
Intervention description(s): Doses will be administered daily for 5 days.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pharmacokinetics; Pharmacology; Drug Safety; Phase 1 Clinical Trials
The Physiotherapy Approaches in Patients With Subacromial Impingement Syndrome
Condition: Subacromial Impingement Syndrome
MeSH terms: Shoulder Impingement Syndrome; Syndrome; Rotator Cuff Injuries
Study type: Interventional

Summary: 
      The aim of this study is to investigate the effectiveness of Electromyographic Biofeedback
      with proprioception exercises on pain, range of motion, muscle strength, proprioception and
      functionality in patients with subacromial impingement syndrome.
    

Detailed description: 
      This study is planned as a prospective, randomized clinical study. Patients with subacromial
      impingement syndrome who volunteered to participate in the study, met the inclusion criteria,
      and signed the consent form were randomly assigned to the proprioception exercise group and
      the proprioception exercise with electromyographic biofeedback group. Demographic and
      clinical data of the patients were recorded. Shoulder function with Disabilities of the Arm,
      Shoulder and Hand scale, pain with VAS, painless active shoulder flexion, abduction, and
      external-internal rotation with goniometer, muscle strength with Manual Muscle Tester,
      proprioception (55°-90°- 125° angles of flexion and abduction, and angular deviations) with
      the Laser-pointer assisted angle reproduction test were evaluated, and patient satisfaction
      was evaluated with The Global Rating of Change Scale. After the initial evaluations were
      completed, only proprioception exercises and proprioception exercises with EMG-BF were
      applied 2 days a week for 8 weeks. Additionally, both groups were given Want exercises.
    

Intervention name(s): Proprioception exercises; Proprioception exercises with Electromyographic Biofeedback; Wand Exercise
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Patients trained for proprioception exercises.; Patients trained for Proprioception exercises with Electromyographic Biofeedback; Patients were educated with wand exercises.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study consisted of patients with subacromial impingement syndrome evaluated by an orthopedist. Patients who met the inclusion criteria were divided into two groups.
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Shoulder impingement syndrome; shoulder pain; proprioception; biofeedback
A Longitudinal Study on the Safety and Efficacy for Subjects With ASD Who Received MeRT
Condition: Autistic Disorder
MeSH terms: Autism Spectrum Disorder; Autistic Disorder
Study type: Observational

Summary: 
      The purpose of this study is to continue to evaluate the long-term effectiveness of Magnetic
      EEG/ECG-Guided Resonance Therapy (MeRT) in children with Autism Spectrum Disorder (ASD). No
      active MeRT treatment will be performed in this study.
    

Detailed description: 
      This clinical trial is a longitudinal study designed to evaluate the safety and efficacy for
      subjects with Autism Spectrum Disorder (ASD) who received Magnetic EEG/ECG-Guided Resonance
      Therapy (MeRT) in the IRB approved clinical trial. A total of twenty-eight (28) subjects will
      be followed in this study. After providing informed consent, twenty-eight (28) subjects who
      participated in the previous protocol will be observed for up to three (3) years post-MeRT
      treatment. During this period, subjects will be evaluated at 104 and 156 weeks post-MeRT
      treatment.
    

Intervention name(s): No intervention
Intervention type(s): Other
Intervention description(s): No intervention. This is a longitudinal study looking at subjects who received MeRT treatment.
Other intervention name(s): No intervention.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Twenty-eight (28) male and female individuals diagnosed with Autism Spectrum Disorder (ASD)
        who participated in the initial treatment protocol will be followed.
      
Keywords: Autism; ASD; Autism Spectrum Disorder
A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With Chronic Hepatitis B.
Condition: Hepatitis B, Chronic
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      This single arm study will assess the efficacy and safety of PEGASYS in patients with chronic
      hepatitis B who are either treatment-naive, or who have failed lamivudine- or
      interferon-treatment in the past. All patients will receive PEGASYS, 180 micrograms s.c.
      weekly for 48 weeks, followed by 48 weeks of treatment-free follow-up. The anticipated time
      on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
    


Intervention name(s): peginterferon alfa-2a [Pegasys]
Intervention type(s): Drug
Intervention description(s): 180 micrograms sc weekly for 48 weeks
Intervention MeSH terms: Peginterferon alfa-2a
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
PK and PD Study of IDN-6556 in Subjects With Hepatic Impairment and Matched Healthy Volunteers
Condition: Hepatic Impairment; Liver Diseases; Digestive System Diseases
MeSH terms: Liver Diseases; Digestive System Diseases; Gastrointestinal Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, parallel-group study to compare the pharmacokinetics and
      pharmacodynamics of IDN-6556 following a single 50 mg oral dose of IDN-6556 in subjects with
      mild, moderate, and severe hepatic impairment (defined as Child-Pugh A, B, and C,
      respectively) and matched healthy volunteers with normal hepatic function.
    


Intervention name(s): IDN-6556
Intervention type(s): Drug
Other intervention name(s): emricasan; PF-03491390
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatic Impairment; Pharmacokinetics; Pharmacodynamics
Efficacy and Safety of Oral Salmon Calcitonin in Patients With Knee Osteoarthritis
Condition: Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this Phase III study is to evaluate the efficacy and safety of oral salmon
      calcitonin in the treatment of patients with osteoarthritis of the knee.
    


Intervention name(s): SMC021 Oral Calcitonin; SMC021 Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 0.8mg SMC021 (Oral Calcitoinin) twice daily; Placebo orally, twice daily
Intervention MeSH terms: Calcitonin; Salmon calcitonin; Calcitonin Gene-Related Peptide; Katacalcin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Osteoarthritis, oral salmon calcitonin, treatment, efficacy, tolerability
Effect of Azilsartan on Aldosterone in Postmenopausal Females
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      The purpose of the research is to evaluate the effect of azilsartan medoximil on blood
      pressure and urinary aldosterone levels in postmenopausal females.
    

Detailed description: 
      The study is a randomized, placebo-controlled trial of post-menopausal females with stage 1
      hypertension. The goal is to randomize 40 post-menopausal females with stage 1 hypertension
      and assess whether azilsartan reduces urinary aldosterone levels. We will compare subjects
      having azilsartan medoximil (treatment group) with placebo group. Additionally, a small
      sub-study comparing pre-menopausal and post-menopausal female aldosterone levels was
      performed as well as the presence of aldosterone production in fat cell cultures of a subset
      of 3 patients in the randomized trial.
    

Intervention name(s): Azilsartan medoximil; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): All subjects were randomized to 80mg azilsartan medoxomil (azilsartan) daily or placebo and followed for six months.; All subjects were randomized to 80mg azilsartan medoxomil (azilsartan) daily or placebo and followed for six months.
Other intervention name(s): Edarbi
Intervention MeSH terms: Azilsartan medoxomil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Post Menopause; Female; Obese
A Study to Investigate the Metabolism and Excretion of [14C]-TRV130 in Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the routes of excretion for TRV130 and it's
      metabolites, and to determine and characterize, structurally, the metabolites present in
      plasma, urine, and feces in healthy male subjects.
    

Detailed description: 
      This study is an open-label, non-randomized, metabolism and excretion study of a single 2 mg
      IV dose of [14C] TRV130 (approximately 100 µCi) administered as a 10 mL manual IV push over 2
      minutes in a fasted state.
    

Intervention name(s): Radiolabeled TRV130
Intervention type(s): Drug
Intervention description(s): A single 2 mg IV dose administered as a 10 mL manual IV push over 2 minutes
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Assessment of Zinc Absorption From a Phytic Acid Rich Complementary Food
Condition: Bioavailability
Study type: Observational

Summary: 
      Assessment of zinc absorption from a phytic acid rich complementary food, consumed by young
      children immediately after the addition of the enzyme phytase. A randomized single blind
      study
    


Sampling method: Probability Sample
Study population: 
        Study not related to a disease. Nutrition study without drug drug administration.
        Assessment of zinc absorption from a phytic acid rich complementary food, consumed by young
        children immediately after the addition of the enzyme phytase. A randomized single blind
        study