louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01553396: Muscle Strength and Functional Autonomy of Elderly Women
Official title: Muscle Strength and Functional Autonomy of Normo-IGF-1 Elderly Women With Skeletal Muscle Dysfunctions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Muscle, Ligament and Fascia Disorders
Lead sponsor: Euro-American Network of Human Kinetics
Sponsor class: OTHER
First posted: 2012-03-14
Enrollment: 35
Sex: FEMALE
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population consists of 123 elderly women residents of São Lucas shelter, located in Cacimba Velha, Teresina-PI, Brazil. The sample consists of 35 elderly women. The elderly participants in the study signed a written informed consent.

Brief summary: This study shows an evaluation of the correlation between the muscle strength levels and functional autonomy of elderly women.

Detailed description: The aim of this study was to evaluate the correlation between the muscle strength levels and functional autonomy of elderly women with impaired muscle-skeletal system depending on the normal IGF-1 level. The target-population was composed by elderly women aged between 60 and 75 years (age: 67.79 ± 5.11 years, BMI: 28.01 ± 5.4), residents of an asylum, with IGF-1 levels within the normal values for the age (normo-IGF-1). Evaluations of the muscle strength (1-RM test) and the functional autonomy (GDLAM Protocol) in the performance of activities of daily living (ADL), and a measurement of basal serum levels of IGF-1 (Chemiluminescence method) were performed.

Eligibility criteria: Inclusion Criteria:

* present a muscle-skeletal dysfunction, such as osteoporosis, arthritis, tendinitis, but being able to perform their ADL without help from others;
* did not practice physical activity for at least 12 months;
* provide a normal IGF-1 level for their age;

Exclusion Criteria:

* elderly women unfit to perform the strength and functional autonomy tests for the medical assessment;

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University Castelo Branco (Rio de Janeiro, Brazil)
name: Estélio HM Dantas, DSc
role: STUDY_CHAIR
References:
Clinical trial NCT04246996: Gentamicin Intravesical Efficacy for Infection of Urinary Tract
Official title: Gentamicin Intravesical Efficacy for Infection of Urinary Tract
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Postoperative Urinary Tract Infection
Pelvic Organ Prolapse
Stress Urinary Incontinence
Keywords: gentamicin sulfate
pelvic organ prolapse surgery
midurethral sling
bladder instillation
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: University of California, San Diego
First posted: 2020-01-29
Enrollment: 370
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Urinary tract infection (UTI) is a common problem after surgery for pelvic organ prolapse and stress urinary incontinence. This prospective, randomized, single-masked (subject), two-parallel armed study aims to determine the effect of a single postoperative intravesical instillation of 80 mg of gentamicin sulfate in 50 mL of saline versus usual care on the proportion of women treated for UTI within 6 weeks following surgery for pelvic organ prolapse (POP) or stress urinary incontinence (SUI).


Eligibility criteria: Inclusion Criteria:

* Adult women undergoing pelvic organ prolapse surgery and/or stress urinary incontinence surgery with surgical plan for at least 1 cystoscopy and will leave the operating room with a standard-of-care transurethral catheter.
* Negative urine culture within 4 weeks or completion of UTI treatment ≥48 hours prior to surgery

Exclusion Criteria:

* History of allergic reaction or anaphylaxis to gentamicin sulfate or to sodium metabisulfite (one of the preservatives in the gentamicin sulfate product)
* Abnormal intraoperative urinary tract finding (e.g. bladder mass, stone, or fistula)
* Intraoperative urinary tract injury
* Suppressive recurrent UTI treatment
* Chronic indwelling catheter/self-catheterization
* Unable to provide informed consent
* Severe renal impairment - glomerular filtration rate of less than 30 mL / minute
* Current pregnancy
* Currently incarcerated

Primary outcomes:
measure: Post-operative Urinary Tract Infection
timeFrame: Within 6 weeks after surgery
Secondary outcomes:
measure: Adverse Events
timeFrame: Within 6 weeks after surgery
measure: Number of Participants With Isolated Uropathogen on Post-operative Urine Culture
timeFrame: Within 6 weeks after surgery
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: UC San Diego Health
state: California
city: San Diego
country: United States
facility: Kaiser Permanente San Diego
state: California
Study officials:
affiliation: Kaiser Permanente
name: Kimberly L Ferrante, M.D., M.A.S.
role: PRINCIPAL_INVESTIGATOR
affiliation: UC San Diego Health
name: Marianna Alperin, M.D., M.S.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05602896: Reducing 30-Day Sepsis Readmissions: Impact of a Post Discharge Education Program
Official title: Reducing 30-Day Sepsis Readmissions: Impact of a Post Discharge Education Program
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Sepsis
Keywords: sepsis
education
cancer
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: BJC HealthCare
name: Viven Health
First posted: 2022-11-02
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study will advance the knowledge in the field by determining the effectiveness of discharge education regarding prevention of a new infection which is the highest cause of readmission for sepsis patient. In evaluating the impact care teams will develop a clearer link between specific home-based education interventions and infection prevention. This study is an exploratory study designed to identify whether patient education through an innovative teaching method can have an impact on readmissions. This study may the first of several based on findings from this initial, exploratory study.


Eligibility criteria: Inclusion Criteria:

* Oncology patients discharged to home following a diagnosis of sepsis, severe sepsis or septic shock
* Patient must have a mobile phone/device
* English speakers
* Age range 18 - 85 years

Exclusion Criteria:

* Less than 18 years of age and older than 85 years of age
* No mobile phone/device
* Non-English speaking
* No diagnosis of sepsis, severe sepsis, or septic shock
* Non-Oncology patient

Primary outcomes:
measure: Readmission rates
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: BJC HealthCare
name: Nancy Bickel, MSN, APRN, ANCP-BC, ACNS-BC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01985958: A Pilot Study to Evaluate Radiotherapy-Induced Anti-Tumor Immunity in Metastatic Carcinoma of the Pancreas
Official title: A Pilot Study to Evaluate Radiotherapy-Induced Ant-Tumor Immunity in Metastatic Carcinoma of the Pancreas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Histological or Cytological Diagnosis of Pancreatic Carcinoma
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2013-11-18
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Primary Objective: To estimate the rate at which radiotherapy to the primary or a metastatic lesion produces an immune response in patients with metastatic carcinoma of the pancreas.

Secondary Objectives: To characterize the kinetics of an immune response induced by radiotherapy. To characterize the dependency of the immune response on prior exposure to chemotherapy.


Eligibility criteria: Inclusion Criteria:

* Histological or cytological diagnosis of pancreatic carcinoma
* Patients ≥ 18 years of age
* Eastern Cooperative Oncology Group (ECOG) performance status 0,1,or 2
* Patients must have distant metastatic disease (stage 4)
* Satisfactory organ and bone marrow function as defined by: Absolute neutrophil count\> 1,000/uL, Platelets \> 75,000uL Hemoglobin \> 9 Bilirubin ≤ 2.0x the institutional normal upper limit unless secondary to bile duct obstruction by tumor,
* Creatinine ≤ 1.5x the institutional normal upper limit
* Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 5x the institutional normal upper limit.
* A clinical recommendation for radiotherapy to the primary or a metastatic lesion had been made.
* Must be able to provide informed consent.

Exclusion Criteria:

* No prior radiation to the area planned for radiotherapy
* Active invasive cancer other than pancreatic adenocarcinoma. Non-melanoma skin cancer, superficial cervical or bladder cancer and prostate cancer with PSA level \< 1.0 are not excluded.
* Known HIV, HCV and/or HBV positive (by patient report/medical record)
* Patients with ongoing or active infection
* Planned concurrent treatment with systemic high dose corticosteroids.
* Received an anticancer treatment (systemic therapy or radiation therapy)within 21 days prior to enrollment.
* Immunotherapy (e.g. monoclonal antibodies)within 21 days prior to enrollment.
* Immunosuppressive therapies (e.g. steroids, cyclosporine) are not permitted.

Primary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: One Year
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Abramson Cancer Center at Penn Medicine
name: Edgar Ben-Josef, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06108258: Newborn Phosphocalcic Metabolism After Intravenous Iron Administration During Pregnancy
Official title: Newborn Phosphocalcic Metabolism After Intravenous Iron Administration During Pregnancy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Iron Induced Hypophosphatemia
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2023-10-30
Enrollment: 43
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with an uncomplicated term (≥ 37 weeks) single pregnancy who received IV iron or oral iron substitution from the 2nd trimester of pregnancy (\>12 weeks of pregnancy) to the day of delivery

Brief summary: Iron deficiency anemia (IDA) is a very common health problem during pregnancy and intravenous (IV) iron substitution has become part of routine management. Recent studies have raised concerns about association of IV iron infusion and development of secondary transitory hypophosphatemia (HP) in adults including pregnant women. The study aimed to evaluate the impact of IV iron administration during pregnancy on newborn's phosphatemia.

The investigators conducted a prospective, single-center, observational study in the Geneva University Hospitals (HUG), from September 2022 to March 2023. Pregnant women treated either with IV iron or with oral iron during pregnancy were included. At delivery, a maternal blood sample to assess hemoglobin, hematocrit, ferritin, phosphate and calcium and an umbilical cord blood sample to assess levels of phosphate and calcium were collected. Difference in demographics and clinical characteristics between the two groups were explored using univariate analyses. Multivariate analyses were performed to test the contribution of IV iron substitution on cord blood phosphatemia and calcemia, considering potential confounding factors. Neonatal HP was defined as a phosphate level lower than 1.3 mmol/L.


Eligibility criteria: Inclusion Criteria:

* Single pregnancy
* Term (\>37SA) pregnancy
* Oral or IV iron substitution from second trimester

Exclusion Criteria:

* Multiple pregnancy
* Fetal anomalies
* Preterm birth

Primary outcomes:
measure: Concentration of cord blood phosphate in neonates
timeFrame: Single timepoint at delivery
Secondary outcomes:
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Geneva University Hospitals
Study officials:
References:
Clinical trial NCT04350658: TAVR Without Predilatation
Official title: Feasibility and Safety of TAVI Without Predilatation: an Observational All Comers Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Aortic Stenosis
Keywords: TAVR
Balloon prediltation
success of crossing the valve
direct implanation
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2020-04-17
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all comers patients undergoing TAVR using transfemoral or transcaorotid approaches

Brief summary: The procedure is performed via transfemoral or transcaprotid access; Patients were confirmed to be eligible for TAVR by a multidisciplinary heart team including at least an interventional cardiologist, a cardiothoracic surgeon and an anesthetist. All TAVR implantation procedures were performed with the Edwards SAPIEN 3 THV or the MEDTRONIC CoreValve EVOLUT . For all patients, both vascular access and aortic valve were evaluated before the procedure by multislice computerized tomographic angiography (MSCT) of the entire aorta using vascular windows settings. The prosthesis and the vascular access were left to the discretion of the operating team. Transfemoral access was the first choice when possible. All TAVR procedures were performed in the same hybrid room (in Montpellier University Hospital), Most TAVR were performed under sedation or general anesthesia using mild low profile 14-16 French delivery systems and using percutaneous or surgical vascular access.


Eligibility criteria: Inclusion criteria:

- patients undergoing TAVR via transfemoral or rascoarotid access

Exclusion criteria:

- others access (subclavian, apical, transaortic)

Primary outcomes:
measure: success of the direct implantation
timeFrame: 1 day
Secondary outcomes:
measure: Indidence of post dilatation
timeFrame: 1 day
measure: Underexpansion of the Edwards SAPIEN 3 THV
timeFrame: 1 day
measure: risks factors of failure of crossing
timeFrame: 1 day
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Florence Leclercq, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00247858: Analysis of Methicillin Resistant Staphylococcus Aureus (MRSA) Obtained Through the Emergency Department in a Tertiary Care Hospital in Vancouver Canada From 2001-2005
Official title: Analysis of Methicillin Resistant Staphylococcus Aureus (MRSA) Obtained Through the Emergency Department in a Tertiary Care Hospital in Vancouver Canada From 2001-2005
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infection With MRSA Bacteria
Keywords: MRSA, USA300, CMRSA-10, CMRSA-6, soft tissue abscesses
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2005-11-02
Enrollment: 97
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with a microbiological sample submitted from the emergency department of the study hospital.

Brief summary: To analyze microbiological data from MRSA samples obtained through the emergency department from 2001-2005. There is a strong clinical suspicion that we are now seeing an outbreak of a new strain of MRSA and we plan to better characterize the Vancouver population and complete a chart review to assess specific associated factors.

Detailed description: Pulse field gel electrophoresis, SCC mec typing, antibiotic susceptibilities, presence of the Panton-Valentine Leukocidin gene will be carried out. Clinical manifestations and associated factors will be assessed via chart review. These include: recent antibiotic use, recent hospitalization, IV drug use, HIV status, number of co-morbidities identified, presence of soft tissue abscess, post operative status, presence of bacteremia, residence in Vancouver's downtown eastside (an area of particularly low socioeconomic status).

Eligibility criteria: Inclusion Criteria:

* Patient had a microbiological sample submitted from the emergency department of the study hospital from 2001- 2005 which grew MRSA.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Steve Reynolds, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03135158: The Association Between Shock Index and Severity of Postpartum Blood Loss
Official title: The Association Between Shock Index and Severity of Postpartum Blood Loss: An Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postpartum Hemorrhage
Lead sponsor: Gynuity Health Projects
Sponsor class: OTHER
Collaborators: name: Fundacion Clinica Valle del Lili
First posted: 2017-05-01
Enrollment: 298
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All women presenting for vaginal delivery will be invited to participate

Brief summary: The present study aims to determine the relationship between postpartum changes in the shock index and the severity of blood loss and other PPH results. Blood loss, heart rate and blood pressure will be systematically measured in the postpartum period in all participating women to explore new clinical indicators to identify those requiring clinical intervention for excessive bleeding.


Eligibility criteria: Inclusion Criteria:

* Receive care for vaginal delivery

Exclusion Criteria:

* Scheduled or transferred for cesarean section
* Cannot give informed consent
* Are not willing and/or cannot answer the questionnaire on their background

Primary outcomes:
measure: Correlation between blood loss and shock index
timeFrame: Within 1 hour postpartum
Secondary outcomes:
measure: Percentage of women with blood loss ≥ 500 ml and ≥ 1000 ml
timeFrame: Up to two hours postpartum
measure: Median blood loss in the postpartum and interquartile range
timeFrame: Up to two hours postpartum
measure: Percentage of women who received treatment to control bleeding
timeFrame: Up to two hours postpartum
measure: Average change in Hb measured before and after delivery
timeFrame: Pre-delivery and at least 24 hours postpartum
measure: Percentage of women with complications
timeFrame: Through study completion, an average of 24-48 hours postpartum
Other outcomes:
Locations:
city: Cali
country: Colombia
facility: Fundación Valle del Lili
Study officials:
affiliation: Gynuity Health Projects
name: Beverly Winikoff, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Gynuity Health Projects
name: Jill Durocher
role: PRINCIPAL_INVESTIGATOR
affiliation: Gynuity Health Projects
name: Ilana Dzuba, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02093858: The Mechanism of TCF7L2 and SLC30A8 on Antipsychotic-induced Metabolic Syndrome
Official title: The Mechanism of TCF7L2 and SLC30A8 on Antipsychotic-induced Metabolic Syndrome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Schizophrenia
Metabolic Syndrome
Keywords: Metabolic Syndrome
Lead sponsor: Central South University
Sponsor class: OTHER
First posted: 2014-03-21
Enrollment: 212
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All participants met the Diagnostic and Statistical Manual of Mental Disorder-Fourth Edition (DSM-IV) criteria for first episode schizophrenia.All of the patients and their familier are know of the study and sign the informed consent.

Brief summary: Almost all of antipsychotics can induce metabolic syndrome,Genetic factors play a key role in the development of metabolic syndrome,TCF7L2 and SLC30A8 are strongestly correlated with metabolic syndrome.Moreover,Antipsychotics have an effect on the expression of TCF7L2 and SLC30A8 genes.It indicates the variations of TCF7L2 and SLC30A8 play an important part in the development of antipsychotics-induced metabolic syndrome.

Detailed description: * In this study, we will determine the effect of olanzapine on the expression of TCF7L2 and SLC30A8.
* The relationship of the polymorphism of TCF7L2 and SLC30A8 with antipsychotic-induced metabolic syndrome in schizophrenia patients.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of first episode schizophrenia
* Must be able to swallow tablets
* Take only one antipsychotics

Exclusion Criteria:

* liver or renal or cardiovascular diseases
* pregnant or lactating women
* drug and alcohol dependence

Primary outcomes:
measure: Change in weight and blood glucose
timeFrame: 24 weeks
Secondary outcomes:
measure: Change of the blood pressure and blood lipid
timeFrame: 24 weeks
Other outcomes:
measure: Change of serum insulin
timeFrame: 24 weeks
Locations:
city: Changsha
country: China
facility: Mental Health Institute
state: Hunan
Study officials:
affiliation: Central South University
name: Wu R Rong, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01927458: Transcranial Direct Current Stimulation Aided Rehabilitation of Gait in Subacute Stroke
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Stroke
Neurorehabilitation
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2013-08-22
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is to determine if transcranial direct current stimulation (tDCS)applied over the lower extremity motor cortex in conjunction with treadmill training is effective for improving gait in patients with subacute stroke and to evaluate the effect and predictive value of a single session of anodal tDCS.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Onset of stroke less than 14 days
* First ischemic stroke causing lower limb weakness (MRC score ≤4 in knee extensors) and gait impairment

Exclusion Criteria:

* Contraindications to MRI or TMS
* Other neurological disorders
* Significant somatic or psychiatric disorders
* History of seizures
* Language or cognitive disorders prohibiting participation

Primary outcomes:
measure: Maximal gait speed using the 10-m walking test
timeFrame: Baseline and follow up immediately following the 4 weeks intervention
Secondary outcomes:
measure: Changes in cortical excitability measures
timeFrame: Baseline
measure: Dynamometry: the maximal isometric force of muscles will be assessed by Biodex System 3 PRO dynamometer
timeFrame: Baseline and immediately following the 4 weeks intervention
Other outcomes:
Locations:
city: Hammel
country: Denmark
facility: Hammel Neurocenter
Study officials:
affiliation: University of Aarhus
name: Henning Andersen, Professor
role: STUDY_DIRECTOR
References: