louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04196114: Study on Feasibility of Stimulation on the Lumbar Part of the Spinal Cord to Improve Mobility Recovery in Patients With Sub-acute Spinal Cord Injury
Official title: Study on Feasibility of Targeted Epidural Spinal Stimulation to Improve MObility Recovery in Patients With Sub-acute Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Spinal Cord Injury
Keywords: spinal cord injury
Lead sponsor: Ecole Polytechnique Fédérale de Lausanne
Sponsor class: OTHER
First posted: 2019-12-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The STIMO-2 study aims to investigate TESS-supported rehabilitation training in sub-acute spinal cord injury (\< 6 months post-injury). The primary endpoint of this study is to assess the safety and feasibility of TESS. The preliminary effectiveness of the therapy is the secondary study endpoint. The mobility recovery status of patients, who undergo TESS-supported rehabilitation, will be assessed at 12 months post SCI, compared to their predicted recovery expectations based on standard rehabilitation program


Eligibility criteria: Inclusion criteria (non-exhaustive list)

* Patient enrolled in the EMSCI study
* Age 18 to 70 years old included
* Focal spinal cord injury due to trauma
* Patient with history of SCI within the past 6 months (sub-acute SCI)
* Vertebral lesion T11 or above
* Psychological condition compatible with study participation
* Able and willing to fulfil all study procedures

Exclusion criteria (non-exhaustive list)

* Severe or chronic medical disorder pre-existing SCI affecting rehabilitation
* Active implanted device such as a pacemaker, implantable cardiac defibrillator
* Inability to follow study procedures, e.g. due to language problems, psychological disorders, dementia
* Pregnant or breast feeding
* Participation in other interventional study

Primary outcomes:
measure: Safety Measure: occurence of Serious Adverse Event
timeFrame: Through study completion, until 12 months after injury
measure: Feasibility Measure: use of TESS stimulation (in minutes) for improved mobility
timeFrame: Through study completion, until 12 months after injury
Secondary outcomes:
measure: Preliminary effectiveness: assessment of function recovery of leg motor function using the 6 mnWT distance
timeFrame: Through study completion, until 12 months after injury
measure: Preliminary effectiveness: mobility assessment using SCIM-III mobility score
timeFrame: Through study completion, until 12 months after injury
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: CHUV
state: Vaud
Study officials:
References:
Clinical trial NCT02017314: VAS Correlation With BMI
Official title: Correlation of Postoperative VAS Values and Body Mass Index in Patients Undergoing Abdominal Surgery: A Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Morbid Obesity
Keywords: morbid obesity
postoperative pain
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2013-12-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to observe if any correlation between Body mass index and VAS values exists in patients who has gone under abdominal surgery.

Group I : Patients with BMI\<30 Group II: Patients with BMI between 30 and 34.9 Group III: Patients with BMI between 35 and 39.9 Group IV: Patients with BMI between 40 and 49.9 Group V : Patients with BMI \>50

After the end of surgery patients will be extubated and in the recovery room morphine PCA (patient-controlled analgesia) treatment will be started according to their adjusted body weight. When VAS values over 4,10 mg/kg Paracetamol IV will be used as an escape treatment. VAS values and Delivery and Demand of the PCA and additional need for analgesics will be recorded in the first 48 hours.


Eligibility criteria: Inclusion Criteria:

* patients undergoing abdominal surgery and who will be given PCA treatment for postoperative pain.

Exclusion Criteria:

* patients younger than 18 years old, patients with uncompensated diabetes or related polyneuropathy, patients receiving antidepressants or have a diagnosis of depression

Primary outcomes:
measure: Pain Scores on the Visual Analog Scale
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Cerrahpasa Medical School
state: Marmara
Study officials:
References:
citation: Choi YK, Brolin RE, Wagner BK, Chou S, Etesham S, Pollak P. Efficacy and safety of patient-controlled analgesia for morbidly obese patients following gastric bypass surgery. Obes Surg. 2000 Apr;10(2):154-9. doi: 10.1381/096089200321668703.
Clinical trial NCT00748514: A Capsular Incision and Biochemical Recurrence After Radical Perineal Prostatectomy
Official title: Impact of a Capsular Incision on Biochemical Recurrence After Radical Perineal Prostatectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Radical Perineal Prostatectomy
Keywords: capsular incision
biochemical recurrence
radical perineal prostatectomy
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2008-09-08
Enrollment: 266
Sex: MALE
Minimum age (years): 43
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: the prostate cancer patients treated with radical perineal prostatectomy at single tertiary institution

Brief summary: To evaluate the impact of capsular incisions on biochemical recurrence (BCR) and the potential risk factors of capsular incisions.

Detailed description: The pathological classification of the prostate following radical prostatectomy provides important prognostic information; an accurate pathology report is the cornerstone to cancer treatment and follow-up. In addition to the preoperative serum PSA, Gleason score on pathology specimens, seminal vesicle invasion and lymph node status, and a positive surgical margin with extraprostatic extension (EPE) are significant predictors of clinical and biochemical recurrence. However, the prognostic implication of a capsular incision, a tumor extending to the inked margins without a histologically documented EPE, remains to be defined.

Eligibility criteria: Inclusion Criteria:

* pathologically proven prostate cancer
* follow-up for at least 6 months

Exclusion Criteria:

* insufficient biopsy data
* seminal vesicle invasion or lymph node involvement on pathology
* neoadjuvant or adjuvant therapy

Primary outcomes:
measure: biochemical recurrence of prostate cancer
timeFrame: upto the final date of study
Secondary outcomes:
measure: risk factors for capsular incisions
timeFrame: at surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Urology, Samsung Medical Center, Sungkyunkwan University School of Medicine
Study officials:
affiliation: Department of Urology, Samsung Medical Center, Sungkyunkwan University School of Medicine
name: han yong Choi, professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chuang AY, Nielsen ME, Hernandez DJ, Walsh PC, Epstein JI. The significance of positive surgical margin in areas of capsular incision in otherwise organ confined disease at radical prostatectomy. J Urol. 2007 Oct;178(4 Pt 1):1306-10. doi: 10.1016/j.juro.2007.05.159. Epub 2007 Aug 14.
citation: Shuford MD, Cookson MS, Chang SS, Shintani AK, Tsiatis A, Smith JA Jr, Shappell SB. Adverse prognostic significance of capsular incision with radical retropubic prostatectomy. J Urol. 2004 Jul;172(1):119-23. doi: 10.1097/01.ju.0000132137.02846.ec.
Clinical trial NCT00290914: Safety and Efficacy Study of Vilazodone and Discovering Genetic Markers Associated With Response in Patients With Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Major Depressive Disorder
Lead sponsor: Pharmacology Research Institute
Sponsor class: OTHER
First posted: 2006-02-13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose is to evaluate the safety and usefulness of the investigational drug, vilazodone in depression.


Eligibility criteria: Inclusion Criteria:

* Male or female patients 18-65 years of age, inclusive.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT07024914: Effect of Oxygen Supplementation on Cerebral Oxygenation, Symptoms and Performance During STST in COPD Patients
Official title: Effect of Oxygen Supplementation on Cerebral Oxygenation, Symptoms and Performance During 30 Sec STST in Chronic Obstructivepulmonary Disease Patients, Without Resting Hypoxemia
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Lead sponsor: George Papanicolaou Hospital
Sponsor class: OTHER
First posted: 2025-06-17
Enrollment: 25
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: It is a randomised, single-blind trial of the effect of acute oxygen supplementation on cerebral oxygenation during the 30 sec Sit-To-Stand Test (STST) in chronic obstructive pulmonary disease patients, without resting hypoxemia. After an initial clinical assessment, patients preform the 30sec STST under near-infrared spectroscopy, a non invasive technique which assesses cerebral oxygenation at the prefrontal lobe. Measurements are performed twice, under oxygen supplementation or medical air, in a random order, and the patients are be blinded to the treatment (oxygen or medical air) given.


Eligibility criteria: Inclusion Criteria:

1) clinical diagnosis of COPD, based on smoking history of at least 100 cigarettes and post bronchodilation forced expiratory volume (FEV1) to forced vital capacity (FVC) ratio \<0.7, and 2) resting arterial oxygen partial pressure \>60 mmHg, according to recent (within a week) arterial blood gases assessment.

Exclusion Criteria:

1) recent COPD exacerbation (as indicated by deterioration of respiratory symptoms, hospital admission and/or change in medication within the previous month), 2) history of specific balance problems (i.e., diagnosed neurological or vestibular disorder), 3) spinal surgery, and 4) lower limb musculoskeletal problems (i.e., surgery, injury or pathology at hip, knee, ankle or foot)

-

Primary outcomes:
measure: cerebral oxygenation at the prefrontal lobe
timeFrame: For 2 and a half minutes (one minute of rest, 30 seconds during Sit-To-Stand Test and one minute of recovery after the test)
Secondary outcomes:
measure: Number of repetitions during Sit-To-Stand Test
timeFrame: From the initiation till the end of the Sit-To-Stand Test, that is 30 seconds.
measure: Severity of dyspnea
timeFrame: At the end of the 30 second Sit-To-Stand Test
measure: Severity of fatigue
timeFrame: At the end of the 30 seconds Sit-To-Stand Test
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: Papanikolaou General Hospital
Study officials:
References:
Clinical trial NCT06363214: Impact of Patient Blood Management (PBM) at the Schulthess Clinic
Official title: Impact of Patient Blood Management (PBM) at the Schulthess Clinic A Quality Assurance and Quality Control Project in Major Orthopaedic and Spine Surgery
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Patient Blood Management
Keywords: blood transfusion
orthopedic surgery
coagulation
Lead sponsor: Schulthess Klinik
Sponsor class: OTHER
First posted: 2024-04-12
Enrollment: 16000
Sex: ALL
Minimum age (years): 16
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing elective major orthopedic or spine surgery at the Schulthess Clinic between 2019 and 2024.

Brief summary: Aim of this study is to analyze the transfusion requirements of allogenic blood products at the Schulthess Clinic for patients that had major orthopedic or major spine surgery between 2019 and 2024 order to identify patients at risk for transfusion. Moreover, impact of transfusion requirements and other measures of PBM on patient outcomes will be assessed. These data are required to further improve PBM at the Schulthess Clinic.

Detailed description: At the Schulthess Clinic a significant reduction of RBC's, fresh frozen plasma (FFP) and platelets transfusion could be observed between 2018 and 2022 during the stepwise introduction of PBM for all patients undergoing major orthopedic and spine surgery. RBC, FFP and PT transfusion declined by 76.3%, 73.5% and 99.2% over the 5-year period. Unfortunately however, at the moment no detailed analysis with respect to risk factors for transfusion, specific interventions or outcomes is available. The hypothesis is that the already known reduction of allogenic blood product transfusion at the Schulthess Clinic can be attributed to patients undergoing major primary joint arthroplasties, revision operations and major spine surgery. We assume that patient and procedure related risk factors over time did not significantly change while we expect a major impact of changed transfusion requirements and the stepwise PBM implementation on patient outcomes.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing primary joint arthroplasties or revision surgery: CHOP Code: 81.51, 81.52, 81.52, 81.54
* Patients undergoing major spine surgery: CHOP Code: 7A.6, 7A.7

Exclusion Criteria:

* Patients who did not sign general informed consent

Primary outcomes:
measure: Perioperative transfusion rates
timeFrame: 2019-2024
measure: Risk factors for perioperative transfusion Risk factors for perioperative transfusion Risk factorsfor perioperative transfusion
timeFrame: 2019-2024
Secondary outcomes:
measure: Perioperative rates of coagulation products administered
timeFrame: 2019-2024
measure: Clinical outcomes
timeFrame: 2019-2024
Other outcomes:
Locations:
Study officials:
affiliation: Schulthess Klinik
name: Christoph K Hofer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06694714: Split Face Study of the Duration of Local Anesthetics - Fourth Arm
Official title: Characterizing and Comparing the Duration of Local Anesthetic in Dermatologic Surgery - Fourth Arm
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Anesthesia, Local
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2024-11-19
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a research study to compare how long injectable pain medications (anesthetics) commonly used in dermatologic surgery are effective for. The investigators will investigate the role of anesthetic volume on the duration of action at highly vascular sites.

Detailed description: The investigators seek to further investigate how the vascularity of an anatomical region influences the duration of local anesthetics during dermatologic surgery. The investigators hypothesize that regional vascularity, by increasing the rate of uptake and removal of the anesthetic from the infiltrated site, will significantly reduce the duration of action of increased doses of infiltrative anesthesia. Specifically, the investigators will compare the duration of a commonly used local anesthetic (lidocaine ± epinephrine) injected at two different volumes at the nasal ala. The investigators will use a modification of a previously published approach of non-invasive pinprick testing to assess the duration of local anesthesia. The investigators aim to demonstrate that there will be no clinically significant difference in the duration of action of varying volumes of the same local anesthetic injected at bilateral areas of the face.

This study record uses the same protocol document of a previous study under Clinical Trials record NCT05767749, but documents a fourth arm for which data will be analyzed separately from data in NCT05767749

Eligibility criteria: Inclusion Criteria:

* Male or female ≥ 18 years of age
* Normal skin sensation at both nasal ala assessed by pinprick
* Ability to provide informed consent

Exclusion Criteria:

* Previous adverse reaction to local anesthetic or any components of the local anesthetics being evaluated
* Pregnant or breastfeeding volunteers (assessed by self-report)
* Patients taking monoamineoxidase inhibitors (MAOI) or antidepressants of the triptyline or imipramine types

Primary outcomes:
measure: Time to Return to Baseline Sensation, as Determined by Binary Outcomes (Yes/no) in 15 Minute Increments
timeFrame: Up to 4 hours.
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Kira Minkis, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02760914: Adipose Tissue and Inflammation in Coronary Heart Disease
Official title: Inflammatory Activity in Various Compartments of Adipose Tissue in Patients With Coronary Heart Disease
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Coronary Heart Disease
Keywords: adipose tissue
inflammatory mediators
gene expression
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2016-05-04
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with coronary heart disease undergoing planned coronary artery bypass surgery.

Brief summary: The aims of the present project are to study possible differences in inflammatory gene expression and protein secretion in various compartments of adipose tissue being exposed during open cardiac surgery in patients with coronary heart disease undergoing coronary artery bypass surgery.

Detailed description: The present study is observational with biochemical end-points to disclose inflammatory mechanisms in various compartments of adipose tissue in patients with coronary heart disease (CHD) compared to patients without significant CHD. Fifty patients with CHD undergoing coronary artery bypass surgery with open chest procedure will be included and 20 patients with valve disease without overt CHD undergoing open valve surgery will serve as a control group. No specific restrictions to inclusion other than lack of consent to participate after written and oral information are listed. In patients undergoing open heart surgery for CHD, representative peri-operative biopsies from epicardial, pericardial and subcutaneous fat will be gathered, carefully processed and deep-frozen to 80 degrees of frost for later analyses on histological/cellular components and on messenger ribonucleic acid for selected inflammatory variables. Simultaneously, blood samples (arterial blood at start of operation) will be collected, processed and deep-frozen at 80 degrees of frost for later analyses of relevant circulating inflammatory variables to correlation analyses with tissue samples, possibly also PaxGene tubes for messenger ribonucleic acid in circulating leukocytes.

The study will be conducted according to the Declaration of Helsinki, and in accordance with approval from the Regional Ethics Committee.

Eligibility criteria: Inclusion Criteria:

* Patients with coronary heart disease undergoing coronary artery bypass surgery

Exclusion Criteria:

* None

Primary outcomes:
measure: Inflammasome-related proteins
timeFrame: At inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Svein Solheim
Study officials:
affiliation: Oslo University Hospital, Ullevål, Oslo, Norway
name: Ingebjørg Seljeflot, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00245414: Trial of Pegasys® in Patients With Chronic Hepatitis C
Official title: Post-marketing Clinical Trial of Pegasys® 180μg for Subcutaneous Injection in Patients With Chronic Hepatitis C. General Clinical Study in Interferon (IFN)-Treated and IFN-untreated Chronic Hepatitis C Patients, Except for Those Infected With High Viral Load of Genotype 1b
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Hepatitis C
Lead sponsor: Chugai Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2005-10-28
Enrollment: 108
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the efficacy and safety of Pegasys® 180μg for subcutaneous (s.c.) injection in interferon (IFN)-treated or IFN-untreated chronic hepatitis C patients except for those infected with genotype 1b of hepatitis C virus (HCV) and a high viral load (≥ 100 KIU/mL).

In addition, this study will explore the efficacy and safety of Pegasys® 180μg for s.c. injection given at 2 different periods between 24 and 48 weeks in IFN-untreated chronic hepatitis C patients.


Eligibility criteria: Inclusion Criteria:

* Quantitative serum HCV-RNA is positive except for high viral load of genotype 1b (≥ 100 KIU/mL)
* Observation of serum ALT elevation above upper limit of normal
* Chronic hepatitis is evaluated as the negative result (\< 0) calculated by the method of "formula for discrimination between chronic hepatitis and liver cirrhosis."

Exclusion Criteria:

* Observation of white blood cells ≦ 3000/mm3; neutrophils ≦ 1500/mm3; platelets ≦ 90,000/mm3; or hemoglobin ≦ 10 g/dL.
* Observation of the following situations and disease: severe renal disease, hepatitis B co-infection, de-compensated liver disease, liver cirrhosis, hepatocellular carcinoma, poorly controlled psychiatric disease, seizure disorders, immunologically mediated disease, severe cardiac disease, poorly uncontrolled hypertension, poorly controlled diabetes, chronic pulmonary disease, retinopathy, malignant tumor, and organ transplant

Primary outcomes:
measure: Sustained viral response as undetectable level of HCV-RNA
timeFrame: week 24 from the end of treatment
Secondary outcomes:
measure: Biochemical response as normal level of ALT
timeFrame: week 24 from the end of treatment
measure: Viral response as undetectable level of HCV-RNA
timeFrame: at the end of treatment
Other outcomes:
Locations:
city: Fukuoka
country: Japan
facility: Kyusyu Region
city: Okayama
country: Japan
facility: Chugoku Region
city: Osaka
country: Japan
facility: Kinki Region
city: Sapporo
country: Japan
facility: Hokkaido Region
city: Tokyo
country: Japan
facility: Kanto Region
city: Yamanashi
country: Japan
facility: Tokai Region
Study officials:
affiliation: Chugai Pharmaceutical
name: Ken Kashima
role: STUDY_DIRECTOR
References: