louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02958904: Depressive Symptoms and Sexual Dysfunction in Traumatic Spinal Cord Injury
Official title: Association Between Depressive Symptoms and Sexual Dysfunction in Men With Traumatic Spinal Cord Injury
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Cord Injuries
Male Sexual Dysfunction
Keywords: Sexuality
Spinal cord injuries
Erectile dysfunction
depression
Lead sponsor: Universidade Federal de Pernambuco
Sponsor class: OTHER
First posted: 2016-11-08
Enrollment: 44
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study included 44 men, aged between 18 and 60 years with a clinical diagnosis of traumatic spinal cord injury, injury time less than six months heterosexual and sexually active. The study excluded patients who had erectile dysfunction attributed to endocrine or metabolic disease order, those who underwent surgery in the genital area, such as radical prostatectomy or penile implant and cognitive impairment.

Brief summary: Aims: assess the relationship between sexual function and depressive symptoms in individuals with spinal cord injury.

Detailed description: Method: Observational study of 44 men with spinal cord injury, age above 18 years, injury time more than six months, sexually active and accompanied in Recife referral hospitals. The degree of neurological impairment was assessed using the revised version in 2011 ASIA Impairment Scale (AIS), depressive symptoms were detected by the Beck Depression Inventory, and the evaluation of sexual function was obtained through the Erectile Function of International Index (IIEF). Descriptive statistics and bivariate analysis to assess the association were applied, with 0,05 significance level.

Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of traumatic spinal cord injury
* injury time less than six months
* sexually active

Exclusion Criteria:

* patients who had erectile dysfunction attributed to endocrine or metabolic disease order
* those who underwent surgery in the genital area, such as radical prostatectomy or penile implant
* cognitive impairment

Primary outcomes:
measure: depressive symptoms
timeFrame: one day
Secondary outcomes:
measure: Level of neurological lesion
timeFrame: one day
measure: Degree of neurological lesion
timeFrame: one day
measure: Male Sexual Dysfunction
timeFrame: one day
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03341104: Evaluation of LB in THA
Official title: Evaluation of Intraoperative, Local Site Injections of Liposomal Bupivacaine as an Alternative to Standard Local Anesthetics in Patients Undergoing Total Hip Arthroplasty
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hip Disease
Lead sponsor: OSF Healthcare System
Sponsor class: OTHER
Collaborators: name: University of Illinois College of Medicine at Peoria
First posted: 2017-11-14
Enrollment: 173
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adult patients admitted to acute care facilities for total hip arthroplasty

Brief summary: This study aims to compare the effectiveness of liposomal bupivacaine (LB) versus standard of practice local injection containing plain bupivacaine.

Detailed description: Investigation of liposomal bupivacaine to determine if this drug is a valid alternative to standard of care local anesthesia based on evaluation in total hip arthroplasty This is a retrospective cohort study of consecutive patients undergoing THA at 3 hospitals within a U.S. healthcare system from January 2013 to July 2016. The control group received the standard of care undergoing THA (plain bupivacaine or ropivacaine), while the LB group received a mixture containing this drug as the alternative to the standard care. The outcome variables include hospital length of stay, readmissions, total hospital costs, patient pain scores, discharge disposition, morphine equivalent opioid consumption, and postoperative patient ambulation. Generalized linear models were employed to examine aforementioned outcomes controlling for age, gender, race, BMI, alcohol use, tobacco use, and surgeons..

Eligibility criteria: Inclusion Criteria:

* Males or females over the age of 18
* have undergone a THA surgery during the period of interest January 2013 to July 2016).

Exclusion Criteria:

* excluded from the study based on the following criteria:

  1. Concurrent, painful, physical condition or concurrent surgery that may require analgesic treatment in the postoperative period for pain that is not strictly related to the surgical treatment;
  2. Uncontrolled anxiety, schizophrenia, or other psychiatric disorder; and
  3. Significant renal or hepatic insufficiency.

Primary outcomes:
measure: Comparing physical function of the control group with the experimental group
timeFrame: 43 months
measure: Comparing length of stay in acute care facility of the control group with the experimental group
timeFrame: 43 months
measure: Comparing total hospital costs of the control group with the experimental group
timeFrame: 43 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: OSF HealthCare Ssytem
name: Ed Rainville
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00591604: High-Dose Vitamin D Deficiency in Burn Injury
Official title: Use of High-Dose Vitamin D to Treat Vitamin D Deficiency Following Severe Burn Injury in Children I: A Pilot Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Burn
Keywords: burn
vitamin D
nutrition
burn recovery
Lead sponsor: The University of Texas Medical Branch, Galveston
Sponsor class: OTHER
First posted: 2008-01-11
Enrollment: 0
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: High dose Vitamin D (50,000IU) therapy may increase bone mineral density/bone mineral content after large burns.


Eligibility criteria: Inclusion Criteria:

* 5+ yrs
* Burn size 40% or greater
* Patient can remain around Shriner Hospital for Children area for 16 weeks
* Agree to take Vitamin D

Exclusion Criteria:

* Age less than 5yrs
* Burn size less than 40%
* Pre-existing bone disease or healing fractures
* Underlying chronic disease-endocrine or cancer
* Kidney failure

Primary outcomes:
measure: Increase in overall bone health
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Texas
name: David N Herndon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04439604: Impact of Body Mass Index on Positive End-expiratory Pressure Guided by Electrical Impedance Tomography for Patients Under General Anaesthesia
Official title: Impact of Body Mass Index on Positive End-Expiratory Pressure Guided by Electrical Impedance Tomography for Patients Under General Anesthesia: A Retrospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: General Anesthetic
Positive Expiratory Pressure
Obesity
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2020-06-19
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Surgical Patients

Brief summary: The induction of general anaesthesia is associated with a fall in lung volume due in particular to a decrease in muscle tone and the formation of denitrogenation atelectasis. Many recent studies insist on the need to apply a so-called "protective" strategy of intraoperative ventilation, which combines the use of recruitment manoeuvres, reduced tidal volume (Vt) (6-8ml/kg) and positive expiratory pressure (PEEP) to prevent these phenomena. However, the setting of PEEP remains debated and several authors agree on the need to individualize ventilatory parameters, particularly in obese patients, without describing the individualization tools.

In the ICU, it has been shown that electrical impedance tomography (EIT) can be used to individualise the PEEP level in a simple and non-invasive way. Therefore, we wish to determine whether the use of this technique during general anaesthesia allows for the individualization of PEEP, and whether the value determined is correlated with the body mass index (BMI).


Eligibility criteria: Inclusion Criteria:

* Adult patient
* Patient who received general anesthesia with orotracheal intubation.
* Patient who has undergone surgery of the following types: : abdominal surgery by laparotomy or laparoscopy, emergency or scheduled

Exclusion Criteria:

* NA

Primary outcomes:
measure: electrical impedance tomography
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: Chu Dijon Bourgogne
Study officials:
References:
Clinical trial NCT01099904: A Study on the Effect of Renal Function on the Pharmacakokinetics of RO5024048 (Parent of Prodrug RO5024048) Following Multiple Oral Dose Administration of RO5024048
Official title: The Effect of Renal Function on the Pharmacokinetics of RO4995855 (Parent of ProDrug RO5024048) Following Multiple Oral Dose Administration of RO5024048
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2010-04-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: This open-label, parallel group study will evaluate the effect of renal function on the pharmacokinetics of RO4995855 following multiple oral dose administration of RO5024048 and assess the effect of renal impairment on safety and tolerability of RO5024048. Adult males or females with either normal renal function or mild or moderate renal impairment will receive RO5024048 orally for 5 days. Target sample size is \<50.


Eligibility criteria: Inclusion Criteria:

* male or female adults, 18-75 years of age
* normal, or mildly or moderately impaired renal function (creatinine clearance \>/= 30 mL/min)
* BMI 18-40 kg/m2
* stable renal function
* agree to abstain from alcohol consumption during study drug adminsitration and limit consumption up to the end of the study
* agree to abstain from coffein consumption throughout study

Exclusion Criteria:

* positive urine or blood test for drugs of abuse not under a physician's prescription
* positive for HIV or HCV, or HBV with clinical symptoms or history of hepatitis
* uncontrolled hypertension
* renal transplant, dialysis patient, nephritic syndrome
* clinically significant cardiovascular, central nervous system, gastrointestinal or liver disease or disorder

Primary outcomes:
measure: Phrmacokinetics of RO49958855 (parent molecule) and metabolites following multiple doses of RO5024048: AUC, Cmax, Tmax T1/2, Ae, Cl
timeFrame: sampling days 1 and 3-11
Secondary outcomes:
measure: Effect of renal impairment on safety and tolerability: Adverse events, vital signs, ECG, laboratory parameters
timeFrame: Throughout study, ECG and laboratory assessments days 3, 5, 6 and 17
Other outcomes:
Locations:
city: Orlando
country: United States
state: Florida
city: Knoxville
country: United States
state: Tennessee
city: Christchurch
country: New Zealand
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT01016301: Effects of a Clinical Pharmacist Service on Health-related Quality of Life
Official title: Effects of a Clinical Pharmacist Service on Health-related Quality of Life
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Quality of Life
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
First posted: 2009-11-19
Enrollment: 400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The aim of the present study is to evaluate effects of a clinical pharmacist service on health-related quality of life and prescribing of drugs.

Detailed description: A randomized controlled trial is performed in two internal medicine wards at Sahlgrenska University Hospital, Göteborg, Sweden.

Eligibility criteria: Inclusion Criteria:

* All patients admitted to the wards during week days after decision of a ward physician or nurse if the medical condition allows inclusion

Exclusion Criteria:

* Exclusion criteria are poor Swedish language and planned discharge before the intervention can be performed.
* Patients transferred to wards not belonging to the department of medicine or other hospitals during the hospital stay are also excluded.

Primary outcomes:
measure: Health-related quality of life
timeFrame: 6 months
Secondary outcomes:
measure: Prescribing of drugs
timeFrame: Discharge from hospital
Other outcomes:
Locations:
city: Mölndal
country: Sweden
facility: Sahlgrenska University Hospital
Study officials:
affiliation: Sahlgrenska University Hospital
name: Susanna Wallerstedt, MD, Ass Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bladh L, Ottosson E, Karlsson J, Klintberg L, Wallerstedt SM. Effects of a clinical pharmacist service on health-related quality of life and prescribing of drugs: a randomised controlled trial. BMJ Qual Saf. 2011 Sep;20(9):738-46. doi: 10.1136/bmjqs.2009.039693. Epub 2011 Jan 5.
citation: Wallerstedt SM, Bladh L, Ramsberg J. A cost-effectiveness analysis of an in-hospital clinical pharmacist service. BMJ Open. 2012 Jan 5;2(1):e000329. doi: 10.1136/bmjopen-2011-000329. Print 2012.
Clinical trial NCT00914901: Concentrations of Salmeterol in Blood and Urine
Official title: Blood and Urinary Concentrations of Inhaled Salmeterol in Asthmatic Subjects and Elite Athletes With Asthma.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Asthma
Keywords: Asthma
Doping
Salmeterol
Beta-agonist
Urine concentrations
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
Collaborators: name: Hormone Laboratory, Aker University Hospital, Oslo, Norway
First posted: 2009-06-05
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: The purpose of the study is to assess the blood and urine concentrations of inhaled salmeterol.

Detailed description: The purpose of the study is to assess the serum and urine concentrations of salmeterol after inhalation of 100 microgram salmeterol in one dose.

Furthermore, to evaluate any difference in three groups: 10 healthy men, 10 male asthmatic subjects and 10 male elite athletes with asthma.

Eligibility criteria: Inclusion Criteria:

* Physician-diagnosed asthma with positive reversibility or challenge test.
* Informed consent.
* Age between 18-45 years.
* Sex: male.
* Asthma classified as mild to moderate according to GINA guidelines.
* Used beta-2-agonist in minimum 12 months.

Exclusion Criteria:

* Smokers or ex-smokers with a smoking history of 10 pack years or more.
* Respiratory tract infections within the last 2 weeks prior to study day.
* Subjects with other chronic diseases than asthma and/or allergy.
* Allergy towards the study medicine.
* Use of beta-2-agonist 10 days prior to study day.

Primary outcomes:
measure: Serum and urine concentrations of salmeterol
timeFrame: baseline, 4, 8, and 12 hours after medicine administration
Secondary outcomes:
Other outcomes:
Locations:
city: Kobenhavn NV
country: Denmark
facility: Bispebjerg Hospital, Respiratory Research Unit
Study officials:
affiliation: Bispebjerg Hospital, Respiratory Research Unit
name: Jimmi Elers, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05045001: Pharmacogenetic Studies on Anti-IL-6 Receptor Monoclonal Antibodies on the Treatment of Rheumatic Diseases
Official title: Observational Retrospective Studies on Single Nucleotide Variants (SNPs) on the Interleukin-6 Receptor (IL6R) and Their Influence on the Response to Treatment and Safety in Patients With Specific Rheumatic Diseases
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rheumatoid Arthritis
Idiopathic Juvenile Arthritis
Giant Cell Arteritis
Still Disease
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
First posted: 2021-09-16
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients being followed-up in the Hospital de la Santa Creu i Sant Pau, diagnosed of Rheumatoid Arthritis, Idiopathic Juvenile Arthritis, Still disease or Giant Cell Arteritis treated with anti-IL6R drugs.

Brief summary: Tocilizumab and Sarilumab are first-line biological disease-modifying anti-rheumatic drug (bDMARD) which inhibits Interleukin 6 (IL-6) pathway through blockade of its receptor on the treatment of Rheumatoid Arthritis and other rheumatic diseases as Giant Cell Arteritis, Still's disease and Idiopathic Juvenile Arthritis. At present, there is a lack of evidence to recommend the treatment of one bDMARD over another. Seeking for genetic biomarkers to predict response to treatment could be key towards a personalized treatment strategy in rheumatology.

The investigators aime to evaluate whether functional single nucleotide polymorphisms (SNPs) in the IL6R gene could predict response and/or toxicity in patients with rheumatic diseases treated with anti-IL-6 receptor drugs.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Rheumatoid Arthritis by the American College of Rheumatology (ACR) 2010 criteria or
* Diagnosis of Giant Cell Arteritis by the International League of Associations for Rheumatology (ILAR) criteria or
* Diagnosis of Still disease by classification criteria (Yamaguchi et al.) or
* Diagnosis of Idiopathic Juvenile Arthritis by ACR 1990 criteria.
* All of the previous must have been treated with anti-IL-6R monoclonal antibodies in the last 5 years

Exclusion Criteria:

* \<18 years at recruitment
* Another rheumatic disease different of the ones in the inclusion criteria

Primary outcomes:
measure: DAS28-C-reactive Protein (CRP) change
timeFrame: at 6 months
measure: Rate of adverse events
timeFrame: During treatment with anti-IL6R drugs
measure: CRP change
timeFrame: 6 months
measure: Erythrocyte sedimentation rate (ESR) change
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
Study officials:
affiliation: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
name: Patricia Moya, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01373801: Hemcon© Bandage for Postpartum Bleeding Due to the Multiple Vaginal Lacerations
Official title: THE EFFICACY AND SAFETY OF HEMCON© BANDAGE FOLLOWING SURGICAL REPAIR IN MANAGEMENT OF POSTPARTUM BLEEDING DUE TO THE MULTIPLE VAGINAL LACERATIONS
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postpartum Bleeding
Vaginal Lacerations
Cervical Lacerations
Keywords: Postpartum women, after surgical repair of vaginal and cervical lacerations
Lead sponsor: Soroka University Medical Center
Sponsor class: OTHER
Collaborators: name: HemCon Medical Technologies, Inc
First posted: 2011-06-15
Enrollment: 85
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of the study is to assess the safety and efficacy of the HemCon GuardaCareXR compared to standard bandaging in subjects with post partum hemorrhage as a result of cervical and vaginal lacerations. The primary endpoint will be a cessation of bleeding at 30 minutes after insertion of the dressing.


Eligibility criteria: Inclusion Criteria:

1. Signed Informed Consent
2. Age≥18 year
3. Two or more 2nd degree vaginal lacerations , 3rd degree vaginal lacerations and cervical laceration

Exclusion Criteria:

1. Subjects undertaking anticoagulation treatment
2. Pre-existing coagulopathy
3. Massive uncontrolled bleeding requiring blood transfusions/urgent vascular surgery.
4. Systolic blood pressure \<90mmHg
5. Shellfish allergy

Primary outcomes:
measure: Cessation of bleeding after a 30 minutes
timeFrame: 30 minutes
Secondary outcomes:
measure: Safety composite endpoint
timeFrame: 7 days
measure: Device Success
timeFrame: 6 hours
measure: Procedural success
timeFrame: 6 hours
Other outcomes:
Locations:
city: Beer Sheva
country: Israel
facility: OB\GYN Soroka University Medical Center
Study officials:
affiliation: Soroka University Medical Center
name: Arnon Wiznitzer, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Soroka University Medical Center
name: Victor Novack, M.D. PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05643001: Precision Clinical and Genetic Tools for Brain Health in Hemorrhagic Stroke
Official title: Precision Clinical and Genetic Tools for Brain Health in Hemorrhagic Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemorrhagic Stroke
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Boston University
name: Tufts University
First posted: 2022-12-08
Enrollment: 340
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The overall goal of this study is to increase health care provider awareness for common risk factors and comorbidities in patients with hemorrhagic stroke that are related to impaired brain health, to ultimately improve patients management and associated outcomes. The specific objective is to test the performance and effectiveness of a custom electronic health record (EHR)-based notification module at time of index hospitalization and at follow-up for hemorrhagic stroke survivors, before disparities in access to outpatient care may limit opportunities to intervene.

The investigators hypothesize that notification of health care providers through the EHR will increase measurements of low-density lipoprotein (LDL) and glycated hemoglogbin A1c (HbA1c) and increase evaluation and management rates for obstructive sleep apnea and hearing impairment.


Eligibility criteria: Inclusion Criteria:

* Patients aged 18 years or older
* Presenting with a primary diagnosis of hemorrhagic stroke admitted to Massachusetts General Hospital inpatient stroke service

Exclusion Criteria:

* Patients not meeting above inclusion criteria
* Patients presenting with subdural or epidural hematoma

Primary outcomes:
measure: Proportion of patients with LDL measurements
timeFrame: 12 months
measure: Proportion of patients with HbA1c measurements
timeFrame: 12 months
Secondary outcomes:
measure: Proportion of patients with management of obstructive sleep apnea
timeFrame: 6-months
measure: Proportion of patients with management of hearing impairment
timeFrame: 6-months
measure: Proportion of patients with intensification of lipid-lowering therapy
timeFrame: 6-months
measure: Proportion of patients with intensification of antidiabetic therapy
timeFrame: 6-months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Christopher D Anderson, MD MMSc
role: PRINCIPAL_INVESTIGATOR
References: