louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04325672: Convalescent Plasma to Limit Coronavirus Associated Complications
Official title: Convalescent Plasma to Limit Coronavirus Associated Complications: An Open Label, Phase 2A Study of High-Titer Anti-SARS-CoV-2 Plasma in Hospitalized Patients With COVID-19
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Coronavirus
Keywords: 2019 novel Coronavirus
SARS-CoV-2
COVID-19
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-03-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Researchers are trying to assess the treatment potential and safety of anti-SARS-CoV-2 convalescent plasma in patients with acute respiratory symptoms with confirmed COVID-19.

Detailed description: High titer human convalescent plasma will be extracted from apheresis donations from twenty recently-sick and currently-recovered COVID-19 patients. An open-label, phase 2A clinical trial will then be conducted to administer convalescent plasma to twenty individuals with confirmed cases of COVID-19 to investigate the novel application of convalescent plasma in the treatment strategy of SARS-CoV-2.

Eligibility criteria: Inclusion Criteria:

* Patients must be 18 years of age or older
* Hospitalized with COVID-19 respiratory symptoms and confirmation via COVID-19 SARS-CoV-2 RT-PCR testing. Patient is willing and able to provide written informed consent and comply with all protocol requirements.
* Patient agrees to storage of specimens for future testing.

Exclusion Criteria:

* Female subjects with positive pregnancy test, breastfeeding, or planning to become pregnant/breastfeed during the study period
* Receipt of pooled immunoglobulin in past 30 days
* Contraindication to transfusion or history of prior reactions to transfusion blood products

Primary outcomes:
measure: RNA in SARS-CoV-2
timeFrame: Days 0, 1, 3, 7, 14, 28, 60 and 90 after transfusion
measure: ICU Admissions
timeFrame: 90 days after transfusion
measure: Hospital Mortality
timeFrame: 90 days after transfusion
measure: Hospital Length of Stay (LOS)
timeFrame: 90 days after transfusion
Secondary outcomes:
measure: Type of respiratory support
timeFrame: 90 days after transfusion or until hospital discharge (whichever comes first)
measure: Duration of respiratory support
timeFrame: 90 days after transfusion or until hospital discharge (whichever comes first)
Other outcomes:
Locations:
Study officials:
affiliation: Mayo Clinic
name: Michael Joyner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05442372: Prevalence of HBV in Pregnancy
Official title: Prevalence of Hepatitis B Virus Infection in Pregnancy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatitis B
Keywords: Hepatitis B
Pregnancy
Prevalence
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2022-07-05
Enrollment: 200
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: pregnant women attending antenatal care clinic

Brief summary: The most common mode of HBV transmission is materno-fetal transmission mainly during labor. This study aims to estimate the seroprevalence of HBV infection and the possible risk factors of HBV acquisition in pregnant women in Upper Egypt and to evaluate the predictive value of HBeAg and quantitative HBsAg as surrogate markers for high viremia in pregnant women.

Detailed description: Hepatitis B virus (HBV) is a cause of a vaccine-preventable life-threatening infection of the liver. Worldwide, the estimated number of cases of chronic HBV infection is 296 million cases with about 820 000 deaths, mostly due to liver cirrhosis and hepatocellular carcinoma. The prevalence of HBV infection among pregnant women is estimated to be 1.5-9.5%. The most important risk factor of materno-fetal transmission is high viremia. Other factors include hepatitis B e antigen (HBeAg) seropositivity, HBV S variant, and threatened preterm labor. Quantitative hepatitis B surface antigen (HBsAg) was postulated as a surrogate marker for HBV high viremia in pregnant women by many authors. This study aims to estimate the seroprevalence of HBV infection and the possible risk factors of HBV acquisition in pregnant women in Upper Egypt and to evaluate the predictive value of HBeAg and quantitative HBsAg as surrogate markers for high viremia in pregnant women.

Eligibility criteria: Inclusion Criteria:

* all pregnant women

Exclusion Criteria:

-

Primary outcomes:
measure: HBsAg
timeFrame: 6 months
measure: Risk factors of HBV in pregnancy
timeFrame: 6 months
Secondary outcomes:
measure: correlation between HBeAg and quantitative HBsAg with viral load
timeFrame: 6 months
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University Hospital
Study officials:
affiliation: Faculty of Medicine, Sohag University
name: Amira Maher, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00094146: Sandostatin LAR® Depot in Patients With Primary Insulin Hypersecretion (PIH) and at Least Moderate Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Primary Insulin Hypersecretion
Obesity
Keywords: Primary Insulin Hypersecretion
PIH
Obesity
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2004-10-15
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is in patients with at least moderate obesity (Body Mass Index \[BMI\] \> 30 kg/m2 or approximately 30 or more pounds overweight) and who also produce too much insulin (insulin stores sugar as fat). Sandostatin LAR® Depot suppresses insulin, and is being developed to help with weight loss in people who find it hard to lose weight on their own because they produce too much insulin.

The main purpose of the study is to find the lowest dose of Sandostatin LAR® Depot that safely helps overweight people lose weight. The study will also compare weight loss in obese patients who receive one of three different dosages of Sandostatin LAR Depot or placebo.


Eligibility criteria: Inclusion Criteria:

You may qualify for this study if you:

* are between the ages of 18-70 (male or female)
* are at least moderately obese (BMI \> 30 kg/m2 or approximately 30 or more pounds overweight)
* and pass an oral glucose tolerance test (a 3 hour test to determine if your body produces too much insulin)

Exclusion Criteria:

You are not qualified for this study if you:

* have diabetes
* have been able to lose weight with diet and exercise alone
* have previously received Sandostatin LAR® Depot

Primary outcomes:
measure: The percent change at baseline compared to 6 months in body weight
Secondary outcomes:
measure: Compare changes from baseline and at 6 months in body mass index (BMI), percentage of total body fat percentage of abdominal fat, leptin, and waist-to-hip ratio
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: New Orleans Center for Clinical Research
state: Louisiana
city: Memphis
country: United States
facility: University of Tennessee
state: Tennessee
city: Madison
country: United States
facility: University of Wisconsin Beers-Murphy Clinical Nutrition Clinic
state: Wisconsin
Study officials:
affiliation: Novartis
name: Jennifer Hedrick, MBA
role: STUDY_DIRECTOR
References:
Clinical trial NCT00723346: Administration of Allogenic Red Blood Cells Loaded L-asparaginase in Cases of Relapse of Acute Lymphoblastic Leukaemia
Official title: Administration of Allogenic of Red Blood Cells Loaded L Asparaginase in Acute Lymphoblastic Leukemia Relapse.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Acute Lymphoblastic Leukemia
Keywords: Relapse
Lymphoma lymphoblastic
Lead sponsor: ERYtech Pharma
Sponsor class: INDUSTRY
Collaborators: name: Centre Leon Berard
First posted: 2008-07-28
Enrollment: 25
Sex: ALL
Minimum age (years): 1
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Primary objective :

* To explore the relation between 3 doses of GRASPA and duration of asparagine depletion (\< 2µmol/l)

Secondary objective :

* Pharmacokinetic / Pharmacodynamic parameters
* toxicity
* Study duration : 2 years
* Study treatment : Red blood cells loaded with L asparaginase versus native L asparaginase
* Associated treatments : COPRALL chemotherapy
* Randomization : centralised randomisation on scratching list


Eligibility criteria: Inclusion Criteria:

* Subject between 1 and 55 year old
* Subject with acute lymphoblastic leukaemia or lymphoblastic lymphoma (excluded burkitt lymphoma) who have relapsed after first remission (medullary or SNC relapse)
* Or patient who still refractory to first line chemotherapy for an ALL
* Patient who gave written informed consent (2 parents for children)

Exclusion Criteria:

Primary outcomes:
measure: Duration of plasmatic asparagin depletion (< 2µmol/l)
timeFrame: PK points
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hopital Debrousse
Study officials:
affiliation: Hospices Civils de Lyon
name: Yves Bertrand, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05093946: Psychometric Measurement Properties of the Michigan Hand Questionnaire in Patients After Flexor Tendon Repair
Official title: Psychometric Measurement Properties of the German Version of the Michigan Hand Questionnaire in Patients After Flexor Tendon Repair
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Flexor Tendon Rupture
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2021-10-26
Enrollment: 50
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: Patients with flexor tendon injuries in Zone I-V for in the fingers and/or thumb.

Brief summary: The aim of the study is to investigate the psychometric properties of the German Version of the Michigan Hand Questionnaire in patients with flexor tendon injuries, including reliability, validity and interpretability.


Eligibility criteria: Inclusion Criteria:

* Informed consent as documented by signature
* ≥ 18 years old
* Understanding of the German language (written and oral)
* Single and multiple finger injuries
* Primary flexor tendon injuries in Zone I-V for the fingers and/ or thumb
* Treated by the hand surgery department at the Inselspital Bern
* Treated with at least a 4-strand core suture

Exclusion Criteria:

* \< 18 years old
* Inability to follow the procedures of the study, e.g. due to language problems, diagnosed psychological disorders or dementia of the patients
* Replantation of the injured finger
* Fracture of the injured finger
* Primary tendon reconstructions

Primary outcomes:
measure: Change in Michigan Hand Questionnaire (MHQ)
timeFrame: 6, 13, 13 1/2 and 26 weeks after tendon repair
Secondary outcomes:
measure: Disabilities of Shoulder, Arm and Hand Questionnaire
timeFrame: 6, 13 and 26 weeks after tendon repair]
Other outcomes:
Locations:
city: Berne
country: Switzerland
facility: Inselspital, Bern University Hospital
Study officials:
affiliation: Inselspital, Bern University Hospital
name: Bernadette Tobler, Dr. phil.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05415046: Sacral Erector Spinae Plane Blocks in Pediatric Patients
Official title: Retrospective Analyses of Sacral Erector Spinae Plane Blocks in Pediatric Patients: Is it Time to Discuss the Necessity of Caudal Block
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Pain
Lead sponsor: Kocaeli University
Sponsor class: OTHER
First posted: 2022-06-10
Enrollment: 15
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who were operated by Department of Pediatric Surgery and performed sacral ESPB for postoperative analgesia.

Brief summary: Patients who were operated by Department of Pediatric Surgery and who received sacral erector spinae plane blocks as a part of postoperative analgesia management will be scanned.

Detailed description: Erector spinae plane block (ESPB) is a safe and effective regional anesthesia technique in pediatric patients and can be performed at any level of the thoracic and lumbar vertebrae. In addition, ESPB can be performed at the sacral region in the midline. In pediatric patients, sacral ESPB provides effective analgesia and this method can replace caudal blocks.

This study aims to investigate the efficacy of sacral ESPB retrospectively. Demographical data of the patient, indication/surgery type, total volume applied, additional analgesic use, type of the analgesic if used will be investigated.

Eligibility criteria: Inclusion Criteria:

* Patients who were operated by Department of Pediatric Surgery

Exclusion Criteria:

* Incomplete patient forms

Primary outcomes:
measure: Face, Legs, Activity, Cry, Consolability (FLACC) Scale
timeFrame: Postoperative 24th hour.
measure: Rescue analgesic-paracetamol
timeFrame: During the postoperative 24th hour.
measure: Rescue analgesic-ibuprofen
timeFrame: During the postoperative 24th hour.
Secondary outcomes:
Other outcomes:
Locations:
city: Kocaeli
country: Turkey
facility: Kocaeli University Hospital
Study officials:
References:
Clinical trial NCT06798246: HEFTME System for Adjuvant Therapeutic Selection of Locally Advanced UTUC Postoperatively：A Perspective Cohort Study
Official title: Hematoxylin-eosin Staining-based Tumor Microenvironment Subtype System Adjuvant Therapeutic Selection for Locally Advanced Upper Tract Urothelial Carcinoma After Radical Surgery：A Perspective Cohort Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Upper Tract Urothelial Carcinoma
Keywords: HE-stained slides
Tumor microenvironment
Precise subtype
Adjuvant therapy
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
Collaborators: name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: Peking University Third Hospital
name: Fujian Provincial Hospital
First posted: 2025-01-29
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Locally advanced UTUC patients such as pathological diagnosed as UTUC with muscle-invasion stages or lymph nodes metastasis.

Brief summary: This multicenter, real-world study introduces a novel Hematoxylin-eosin staining(H\&E)-based four tumor microenvironment (TME) system (HEFTME system) assisting in prognostic prediction and precise adjuvant treatment selection for laUTUC postoperatively.


Eligibility criteria: Inclusion Criteria:

* pathological diagnose of UTUC;
* Met more than muscle-invasion stages(pT2+) or lymph nodes metastasis.

Exclusion Criteria:

* Patients with early-local stages (pTa/T1/Tis) without LNM+ and those with incomplete pathologic and prognostic information were excluded

Primary outcomes:
measure: DFS
timeFrame: 1 year, 3 years and 5 years
Secondary outcomes:
measure: ORR
timeFrame: 3 month after the start of treatment until the end of treatment
measure: OS
timeFrame: 1 year, 3 years and 5 years
measure: AE
timeFrame: 1-3 months after starting treatment
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05707546: Knowledge, Beliefs and Attitudes of Greek Physiotherapists About Communication With Chronic Musculoskeletal Patients
Official title: Knowledge, Beliefs and Attitudes of Greek Physiotherapists About Motivational Interviewing, Shared Decision Making and Empathetic Communication With Chronic Musculoskeletal Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Musculoskeletal Pain
Chronic Pain
Keywords: empathy
shared decision making
motivational interviewing
physiotherapy
chronic musculoskeletal patients
Lead sponsor: University of Thessaly
Sponsor class: OTHER
First posted: 2023-02-01
Enrollment: 257
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Physiotherapists with chronic musculoskeletal experience and clinical practice in Greece

Brief summary: The purpose of current research study is to assess physiotherapists's knowledge, beliefs and attitudes about empathy, motivational interviewing and shared decision making in chronic musculoskeletal patients. An e-survey study will be conducted based on Checklist for Reporting Results of 52 Internet E-Surveys (CHERRIES)

Detailed description: The main questions it aims to answer are:

What physiotherapists know about the use of empathy, motivational interviewing and shared decision making? What beliefs do physiotherapists have about the appropriate use of communication skills? Whether and how much they use empathy, motivational interview, shared decision-making in clinical practice? What are the main barriers of using communication skills (empathy, motivational interview, joint decision-making) in clinical practice?

Eligibility criteria: Inclusion Criteria:

* Physiotherapists who are member of Panhellenic Association of Physiotherapist in Greece, with active clinical practice in Greece and clinical experience in musculoskeletal disorders (\>12 months).

Exclusion Criteria:

* None

Primary outcomes:
measure: Demographic characteristics
timeFrame: Baseline
measure: Knowledge about Empathy
timeFrame: Baseline
measure: Beliefs about Empathy
timeFrame: Baseline
measure: Attitude about Empathy
timeFrame: Baseline
measure: Barriers about Empathy
timeFrame: Baseline
measure: Knowledge about Shared-Decision Making
timeFrame: Baseline
measure: Beliefs about Shared-Decision Making
timeFrame: Baseline
measure: Attitude about Shared-Decision Making
timeFrame: Baseline
measure: Barriers about Shared-Decision Making
timeFrame: Baseline
measure: Knowledge about Motivational Interviewing
timeFrame: Baseline
measure: Beliefs about Motivational Interviewing
timeFrame: Baseline
measure: Attitude about Motivational Interviewing
timeFrame: Baseline
measure: Barriers about Motivational Interviewing
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Lamia
country: Greece
facility: University of Thessaly
Study officials:
affiliation: University of Thessaly
name: Eleni Kapreli, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01169246: Efficacy of the ATP Switch Automatic Programming in Implantable Cardioverter Defibrillator (ICD) and Cardiac Resynchronization Therapy Defibrillator (CRT-D) Implanted Patients
Official title: Efficacy of the ATP Switch Automatic Programming in ICD and CRT-D Implanted Patients
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Ventricular Arrythmias
Keywords: ATP,CRT, ICD PARADYM
Lead sponsor: MicroPort CRM
Sponsor class: INDUSTRY
Collaborators: name: Sorin Group France SAS
First posted: 2010-07-26
Enrollment: 1254
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: ICD/CRT-D implanted patients population

Brief summary: Primary objective is to assess the efficacy of the new ATP Autoswitch function in simple, dual or triple chamber ICD.

Detailed description: The efficacy rate of the ATP Auto-switch function, defined as the % of VT episodes successfully reduced, will be compared with 85%.

Eligibility criteria: Inclusion Criteria:

* The patient has been implanted (primo implantation or replacement) with an ICD model PARADYM VR 8250, DR 8550, CRT 8750, CRT 8770 models or any similar or higher range device
* ATP Auto-switch function is programmed ON

Exclusion Criteria:

* Presence of a contra-indication to the ICD therapy
* Life expectancy less than 12 months

Primary outcomes:
measure: Ventricular Tachyarrhythmia episode
timeFrame: 2 years
Secondary outcomes:
measure: Arrhythmia incidence
timeFrame: 2 years
Other outcomes:
Locations:
city: Brest
country: France
facility: CHU Brest
Study officials:
affiliation: CHU Rouen
name: SAVOURE Arnaud, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02136446: Prospective Post-market Evaluation of an Echogenic Catheter
Official title: Prospective Post-market Evaluation of an Echogenic Catheter Used in a Peripheral Nerve Block Procedure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Peripheral Nerve Block Procedure
Keywords: Paravertebral block
Mastectomy
Post-operative pain
Echogenic
Peripheral nerve block catheter
Lead sponsor: Smiths Medical, ASD, Inc.
Sponsor class: INDUSTRY
First posted: 2014-05-13
Enrollment: 60
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: Patients scheduled for mastectomy and suitable for paravertebral block will be randomized to one of 2 groups.

Group 1 will have the nerve block performed using a standard non-echogenic needle and catheter under ultrasound guidance. Group 2 will have the block performed using the control needle and an echogenic catheter, all under ultrasound (US) guidance.

The clinician will be blinded to the catheter type and will assess the quality of catheter visualisation of the US image during the procedure, along with adequacy of spread of local anesthetic. The primary outcome will be needle visibility, and secondary outcomes will be block success rate and block quality. An assessment of the patient's pain levels after the procedure will also be conducted.


Eligibility criteria: Inclusion Criteria:

* Patients scheduled to undergo breast surgery requiring use of a peripheral nerve block catheter for establishing a paravertebral block
* Patients classified as ASA (American Society of Anesthesiologists) physical status I, II or III
* Patients at least 18 years old
* Patient is willing and able to provide informed consent for study participation
* Patient has a good understanding of written and verbal English

Exclusion Criteria:

* Patient with contraindications to regional anesthesia technique (e.g. allergy to local anesthetic or other medications used in study)
* Patient with known coagulopathy
* Patient whose target nerve cannot be seen with linear ultrasound probe in a pre-procedure scan. All patients who need a curvilinear probe to visualize the target nerve will be excluded from the study.
* Patients having mastectomy and immediate reconstruction

Primary outcomes:
measure: Visibility of entire catheter length
timeFrame: Day 1, time of procedure
measure: Visibility of catheter tip
timeFrame: Day 1, time of procedure
Secondary outcomes:
measure: Quality of the block
timeFrame: Day 1, time of procedure
measure: Block failure rate
timeFrame: Day 1, time of procedure
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: University College Hospital
Study officials:
affiliation: Smiths Medical
name: Peter R Kratz, MS
role: STUDY_DIRECTOR
References: