louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00676585: Corticosteroid Therapy in Refractory Shock Following Cardiac Arrest
Official title: Corticosteroids Therapy in Refractory Shock Following Cardiac Arrest
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Cardiac Arrest
Keywords: Cardiac Arrest, Shock, Steroids
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
Collaborators: name: American Heart Association
First posted: 2008-05-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The major goal of this project is to determine whether the use of physiologic doses of corticosteroids will decrease time to shock reversal, alters the inflammatory cascade, and alters microcirculatory flow in post-cardiac arrest patients.


Eligibility criteria: Inclusion Criteria:

* Greater than 18 years old
* Either pre-hospital cardiac arrest and ROSC or Inpatient Cardiac Arrest with resultant ROSC
* Vasopressor dependent for a minimum of 1 hour post-arrest

Exclusion Criteria:

* Pregnant
* Indication for Corticosteroids outside of current research proposal
* DNR or comfort care measures
* Presence of septic shock
* Chronic Use (\>1week) of oral Corticosteroids in the last year

Primary outcomes:
measure: Time to Shock Reversal
timeFrame: 7 Days
Secondary outcomes:
measure: Mortality
timeFrame: Length of hospital stay, an average of 9 days with a maximum of 36 days
measure: Sub-group Analysis of Patients With Adrenal Insufficiency
timeFrame: At time of enrollment
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Michael W Donnino, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Donnino MW, Andersen LW, Berg KM, Chase M, Sherwin R, Smithline H, Carney E, Ngo L, Patel PV, Liu X, Cutlip D, Zimetbaum P, Cocchi MN; Collaborating Authors from the Beth Israel Deaconess Medical Center's Center for Resuscitation Science Research Group. Corticosteroid therapy in refractory shock following cardiac arrest: a randomized, double-blind, placebo-controlled, trial. Crit Care. 2016 Apr 3;20:82. doi: 10.1186/s13054-016-1257-x.
Clinical trial NCT05572385: Clinic and Neurophysiology of Aphasia Treatment
Official title: Clinical and Neurophysiological Features of Neurorehabilitation Effects in Cerebrovascular Aphasia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Aphasia, Acquired
Lead sponsor: Klinik Bavaria
Sponsor class: OTHER
First posted: 2022-10-07
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: In the planned study, clinical and electrophysiological features of aphasia recovery in stroke patients are investigated.

Detailed description: Clinical neurorehabilitation faces a major challenge of functional recovery in aphasia, i.e. guiding the structural and temporal dynamics of reorganization within responsible neural networks. Here, according to current research, relevant neural factors affecting the treatment and thus the functional recovery of aphasia patients after stroke are of interest, highlighting structural as well as functional neuroanatomical features. Of particular interest are not only the functional localization of affected cerebral regions, but more the clinical and neurophysiological patterns which might help to factorize and predict the therapeutic outcome. In the planned study, the clinical and neurophysiological characteristics of the dynamics of language function recovery in relation to the intensity of professional speech therapy (constraint induced aphasia therapie - CIAT) will be recorded in 40 patients with aphasia resulting from a cerebrovascular event. The aim of this study is to test the value of neurophysiological aspects based on electroencephalographic (EEG) parameters such as event-related potentials (N400, P600, theta band activity) for the identification of specific neuronal markers, which in turn support predictive statements for individual therapy planning of logopedic treatment in neurorehabilitation.

Eligibility criteria: Inclusion Criteria:

* patients with a cerebrovascular event

Exclusion Criteria:

* premorbid brain disorder

Primary outcomes:
measure: EEG correlates of language reconstitution
timeFrame: 3-6 months after stroke
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04388085: Validity, Reliability and Responsiveness of King's Sarcoidosis Questionnaire in a Danish Population
Official title: Validity, Reliability and Responsiveness of King's Sarcoidosis Questionnaire in a Danish Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sarcoidosis
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2020-05-14
Enrollment: 150
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: Danish patients with sarcoidosis seen in Department of Respiratory Diseases Aarhus Denmark

Brief summary: The King's Sarcoidosis Questionnaire (KSQ) is a brief questionnaire assessing health status in patients with sarcoidosis. The KSQ was previously validated in English German and Dutch.

KSQ will be translated into Danish and validated in a Danish sarcoidosis population.

Detailed description: KSQ will be linguistic validated according to existing guidelines. Consecutive patients with sarcoidosis will complete KSQ and other health questionnaires at baseline, after two weeks and 12 months. Concurrent validity, reliability, and responsiveness will be assessed.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with sarcoidosis
* Signed informed consent

Exclusion Criteria:

* Inability or unwillingness to adhere to the study
* Inability to give informed consent

Primary outcomes:
measure: Internal consistency
timeFrame: At baseline
measure: Test-retest reliability
timeFrame: At baseline
measure: Concurrent validity
timeFrame: At baseline
measure: Responsiveness
timeFrame: 1 year from baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus N
country: Denmark
facility: Aarhus University Hospital. Dep. of Respiatory Diseases and Allergology
Study officials:
affiliation: AU
name: Janne Møller, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06787885: Evaluation of Efficacy and Safety Parameters of Different Antibiotics Regimens for Management of Empyema
Official title: Evaluation of Efficacy and Safety Parameters of Different Antibiotics Regimens for Management of Empyema
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Empyema, Pleural
Lead sponsor: Fayoum University
Sponsor class: OTHER
First posted: 2025-01-22
Enrollment: 90
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the impact of using different antibiotic regimens including single and combined agents as the empirical therapy and evaluate the clinical outcomes regarding safety, efficacy, and pharmacodynamics parameters.


Eligibility criteria: Inclusion Criteria:

Confirmed Diagnosis of Empyema: Patients with a clinical and radiological diagnosis of

Exclusion Criteria:

1 - Hypersensitivity or Allergy to the selected antibiotic: Patients with a known history of hypersensitivity or allergic reactions to used antibiotics.

2- Pregnancy and Lactation

Primary outcomes:
measure: Evalutate different antibiotics
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Fayoum
country: Egypt
facility: Fayoum University hospital
Study officials:
affiliation: Faculty of pharmacy Beni suef University
name: Raghda Roshdy Hussein, Assistant professor
role: STUDY_CHAIR
affiliation: Faculty of pharmacy Fayoum University
name: Marwa Kamal Tolba, Assistant professor
role: STUDY_DIRECTOR
affiliation: Faculty of pharmacy Benisuef University
name: Yassmin Mohamed Medany, Lecturer
role: STUDY_DIRECTOR
affiliation: Faculty of Medicine Fayoum University
name: Mona Ibrahim Ahmed, Assistant professor
role: STUDY_DIRECTOR
affiliation: Faculty of pharmacy Fayoum University
name: Abdelrahman Ahmed Mohamed, Teaching assistant
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02530385: Fecal Microbiota Transplant for Improvement of Metabolism
Official title: Placebo Controlled Study of Fecal Microbiota Transplant (FMT) to Impact Body Weight and Glycemic Control in Adults Using a Frozen Encapsulated Inoculum
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Obesity
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2015-08-21
Enrollment: 24
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to study the impact of gut bacteria on weight. Fecal microbiota transplantation (FMT) transfers intestinal bacteria by a "stool transplant" from a healthy, lean person to a person with obesity.

Detailed description: Multiple lines of evidence suggest that gut microbiota play an important role in regulating human metabolism. In this study, subjects will receive FMT capsules from lean metabolically healthy donors to study effects on body weight and insulin sensitivity. Subjects who participate will be randomized 1:1 to receive either active FMT capsules or placebo capsules. Subjects and providers will be blinded to treatment assignment. The study will last for 24 weeks. Subjects will be asked to come to MGH for a baseline visit at week 0, return for 6 weekly visits and come back at week 12. Major study outcomes include change in weight, insulin sensitivity, and body composition. Fecal samples will also be collected for intestinal microbiome analysis.

Eligibility criteria: Inclusion Criteria:

* BMI ≥30 kg/m2
* Because of frequent study mandated visits, only subjects living within reasonable driving distance of Massachusetts General Hospital may be enrolled

Exclusion Criteria:

* Pregnant women
* Use of diabetic medications or weight loss medications in the preceding 1 year
* Significant gastrointestinal disorders
* Significant food allergies
* Immunosuppressed patients

Primary outcomes:
measure: Percent Change From Baseline in Insulin Resistance Based on Insulin-Stimulated Glucose Uptake (M) During Hyperinsulinemic Euglycemic Clamp
timeFrame: Baseline and 6 weeks
Secondary outcomes:
measure: Change in Insulin Resistance Based on Homeostasic Model Assessment of Insulin Resistance (HOMA-IR)
timeFrame: Baseline and 12 weeks
measure: Body Weight (Metabolic Scale)
timeFrame: Baseline and 12 weeks
measure: Lean Mass
timeFrame: Baseline and 12 weeks
measure: Fat Mass
timeFrame: Baseline and 12 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
References:
citation: Yu EW, Gao L, Stastka P, Cheney MC, Mahabamunuge J, Torres Soto M, Ford CB, Bryant JA, Henn MR, Hohmann EL. Fecal microbiota transplantation for the improvement of metabolism in obesity: The FMT-TRIM double-blind placebo-controlled pilot trial. PLoS Med. 2020 Mar 9;17(3):e1003051. doi: 10.1371/journal.pmed.1003051. eCollection 2020 Mar.
Clinical trial NCT06601985: Exploring the Effect of Colonic J-pouch in Anorectal Preservation Surgery for Ultra-low Rectal Cancer.
Official title: Exploring the Effect of Applying Colonic J-pouch Forming in Anorectal Preservation Surgery for Ultra-low Rectal Cancer on Postoperative Bowel Control Function
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Rectum Cancer
Faecal Incontinence
Faecal Incontinence with Faecal Urgency
Low Anterior Resection Syndrome
Leakage, Anastomotic
Lead sponsor: Shanghai 10th People's Hospital
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 154
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: Our study population is the patients who diagnosed as ultra-low rectal adenocarcinoma cases by preoperative pathology and meet the eligibility criteria.

Brief summary: The occurrence of colorectal cancer has increased from the third most common cancer in 2018 to the second most common cancer in 2023. The practice of anal preservation surgery for ultra-low rectal cancer is being adopted gradually. Ultra-low rectal cancer patients who have undergone anal preservation are at an increased risk of developing significant bowel complications. The objective of this study was to examine the relationship between the type of bowel reconstruction following anal preservation surgery, and the subsequent outcomes of bowel function, quality of life and complication rates in patients with ultra-low rectal cancer.


Eligibility criteria: Inclusion Criteria:

1. A confirmed diagnosis of intestinal cancer, with the lower edge of the tumour \&amp;lt;5 cm from the anus or \&amp;lt;3 cm from the dentate line, and treated with anus-preserving surgery;
2. No distant metastasis;
3. Age \&amp;gt;18 years old;
4. Voluntary enrollment in the study and signing of an informed consent.

Exclusion Criteria:

1. A combination of severe cardiopulmonary, hepatic, renal, and other underlying diseases with a greater anaesthetic risk (ASA ≥ grade 4);
2. preoperative anal stenosis and anal nonfunction;
3. temporary stoma diversion.

Primary outcomes:
measure: LARS score
timeFrame: From 1 month postoperatively to 12 months postoperatively
measure: FIQL
timeFrame: From 1 month postoperatively to 12 months postoperatively
measure: Vaizey score
timeFrame: From 1 month postoperatively to 12 months postoperatively
measure: Wexner score
timeFrame: From 1 month postoperatively to 12 months postoperatively
Secondary outcomes:
measure: Surgical complications
timeFrame: From 1 month postoperatively to 12 months postoperatively
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Tenth People&amp;amp;#39;s Hospital, Yanchang Road, Jing&amp;amp;#39;an District, Shanghai, China
state: jingan
Study officials:
affiliation: Shanghai Tenth People&amp;#39;s Hospital
name: Cheng-Le Zhuang, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT04594785: Evaluation of Post Infectious Inflammatory Reaction (PIIR) Concerning Children After Streptococcus Pneumoniae, Streptococcus Pyogenes and Neisseria Meningococcus Invasive Infection
Official title: Evaluation of Post Infectious Inflammatory Reaction (PIIR) in a Retrospective Study Concerning Children After Streptococcus Pneumoniae, Streptococcus Pyogenes and Neisseria Meningococcus Invasive Infection
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Streptococcus Pneumonia
Streptococcus Pyogenes Infection
Neisseria Meningitides Meningitis
Keywords: post-infectious inflammatory reactions
Neisseria Meningitis
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2020-10-20
Enrollment: 150
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric population

Brief summary: As Covid 19 manifestations that have been recently described, inflammatory manifestation have major impact in infectious disease lesions. Some of them are delayed and provide Post infectious inflammatory reaction (PIIR), they are challenging for diagnosis and for management. Clinician have to avoid unnecessary antibiotic thearapy and in if necessary have to give immunosuppressive therapy. Except for rheumatic disease for group A streptococcus (GAS) infections there are not stanrdized diagnostic criteria and therapeutic protocol, and PIIR have probably a suboptimal management. In this context the investigators aim to explore PIIR in the 3 most frequent bacterial invasive infection in France, by a retrospective monocentric study. The investigators include all children betwwen 2012 and 2018 hospitalized for infections by Streptococcus pneumoniae (SP), Neisseria meningitidis (NM), and GAS invasive infections.


Eligibility criteria: Inclusion criteria:

* Less than 18 years of age
* Fever associated with GAS, NM, or SP invasive infection

Exclusion criteria:

* age \> 18 years
* Impossibility to obtain the consent of parents / legal representatives.

Primary outcomes:
measure: Describe the frequency PIIRs
timeFrame: 1 day
Secondary outcomes:
measure: Characteristics PIIRs following invasive pneumococcal, meningococcal, or group A Streptococcal infection
timeFrame: 1 day
Other outcomes:
measure: Predictors of PIIRs
timeFrame: 1 day
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Eric JEZIORSKI
role: STUDY_DIRECTOR
References:
Clinical trial NCT02180685: Reconstruction of the Medial Patellofemoral Ligament - A Randomised Controlled Trial Comparing Two Surgery Technics
Official title: Reconstruction of the Medial Patellofemoral Ligament - A Randomised Controlled Trial Comparing Two Surgery Technics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Stability
Patella Luxation
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
First posted: 2014-07-03
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this present study is to determine which surgery technic provides the best clinical outcome after medial patellofemoral ligament reconstruction comparing suture anchors and screw fixation in medial femoral condyle.


Eligibility criteria: Inclusion Criteria:

* patella luxation, more than 2 times

Exclusion Criteria:

* cartilage damage (grad 3)

Primary outcomes:
measure: Evaluation of subjective symptoms with a patient reported outcome score
timeFrame: Baseline, 6 months 12 Months, 24 months
Secondary outcomes:
measure: Patient reported outcome scores
timeFrame: Baseline, 6 months 12 Months, 24 months
measure: Patient reported outcome scores
timeFrame: Baseline, 6 months 12 Months, 24 months
measure: Re-operation rate
timeFrame: Baseline, 6 months 12 Months, 24 months
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Division of Sports Trauma, Tage-Hansens Gade 2b
Study officials:
References:
Clinical trial NCT04169685: Dexmedetomidine for Sedation Undergoing Bronchoscopy
Official title: Comparison of Dexmedetomidine and Propofol for Sedation in Adult Patients Undergoing Flexible Bronchoscopy -A Retrospective Review
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Safety Issues
Lead sponsor: Kaohsiung Medical University
Sponsor class: OTHER
First posted: 2019-11-20
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients undergoing flexible bronchoscopy

Brief summary: Several sedatives or analgesics can be used to achieve appropriate levels of sedation for endoscopic procedures. Dexmedetomide is notable for providing sedation without respiratory depression. We hypothesized dexmedetomide is more suitable for sedation of bronchoscopy than other sedative drugs.

Detailed description: A retrospective chart review was conducted. All patients undergoing flexible bronchoscopy with moderate sedation were enrolled.The primary analysis outcome was safety profile during procedure included incidence of procedure interruption, incidence of snoring and observed apnea, transient hypoxemia and hypotension. The secondary outcome was measured by recovery profile (awake and ambulation time).

Eligibility criteria: Inclusion Criteria:

* sedation undergoing flexible bronchoscopy

Exclusion Criteria:

* without sedation undergoing flexible bronchoscopy

Primary outcomes:
measure: safety profile during procedure
timeFrame: during procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Hospital
Study officials:
affiliation: Kaohsiung Medical University
name: sheng hua wu, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05330585: fNIRs, Listening Effort, and Speech Intelligibility
Official title: Functional Near-infrared Spectroscopy (fNIRS) as a Measure of Listening Effort and Speech Intelligibility in Adults With Hearing Loss
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hearing Loss
Lead sponsor: Sonova AG
Sponsor class: INDUSTRY
Collaborators: name: Toronto Metropolitan University
First posted: 2022-04-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of the current study is to measure oxygenation in the PFC using fNIRS in a sample of older adults with hearing loss. Adults with hearing loss will be asked to repeat the final word from low-context sentences in noise at two SNRs; a hard SNR (individually-measured SNR-50), and an easy SNR (SNR-50 + 10 dB) both without and with hearing aids set to a directional mode. The procedure will be a within-subject repeated measures. Stimuli will be randomized.

Detailed description: See above.

Eligibility criteria: Inclusion Criteria:

* Adults (18-99 years) with ≥3 months hearing aid experience
* binaural, symmetric, sensorineural N2 (mild) to N6 (severe) hearing loss
* fluent in English

Exclusion Criteria:

* children/teenagers
* normal hearing or hearing loss exceeding N6 (severe) by 10 dB

Primary outcomes:
measure: Listening effort
timeFrame: Up to 2 hours during 1 session
measure: Speech-in-noise performance
timeFrame: Up to 2 hours during 1 session
Secondary outcomes:
Other outcomes:
Locations:
city: Mississauga
country: Canada
facility: Sonova Innovation Centre Toronto
state: Ontario
Study officials:
affiliation: Sonova AG
name: Jinyu Qian, PhD
role: PRINCIPAL_INVESTIGATOR
References: