louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01919957: Episodic Memory Before and After Surgery in Drug-resistant Partial Epilepsies
Official title: Etude de la mémoire Avant et après Chirurgie d'Une épilepsie Partielle pharmacorésistante : Bases Neurobiologiques, Applications Cliniques
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Epilepsy, Unspecified, Pharmacologically Resistant
Memory Impairment
Keywords: epilepsy
surgery
functional MRI
memory outcome
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
First posted: 2013-08-09
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study has two purposes: firstly, a better understanding of the neurobiological processes underlying episodic memory and, secondly, the development of useful clinical applications for epileptic patients, in particular the prediction of postoperative memory deficits and the development of cognitive remediation therapies.

Memory performances during a fMRI experiment will be assessed in controls and epileptic patients before and after the surgery.


Eligibility criteria: Inclusion Criteria:

* Patients with drug-resistant epilepsy
* Age of 18 years or more
* Follow-up in the epilepsy unit at Pitié-Salpêtrière Hospital
* Before or after the presurgical evaluation unit including a video-EEG monitoring, a structural brain imaging and a full neuropsychological assessment
* Covered by a social security system
* Signing of consent form

Exclusion Criteria:

* Persons under guardianship, curatorship or any other administrative or judicial deprivation of rights and freedom
* Refusal to consent form
* Contraindications to MRI
* Pregnancy
* Refusal to be informed in the case of detection of an abnormality during the experiment

Primary outcomes:
measure: Measure of successfull encoding
timeFrame: 8 years
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: INSERM - Plateau IRM du CENIR, CR-ICM Hôpital Pitié-Salpêtrière, 47/83 Boulevard de l'Hôpital
state: Cedex 13
Study officials:
affiliation: Service de Soins de Suites et Réadaptation Neurologique, Hôpital de la Pitié-Salpêtrière, 47/83 Bd de l'Hôpital, 75651 Paris Cedex 13
name: Sophie Dupont, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05172557: IBD and Women's Health Wellness Program
Official title: Evaluating the Need and Impact of a Multifaceted Wellness Program on the Health Related Quality of Life (HRQOL), Disease Activity, and Healthcare Utilization in Female Patients With Inflammatory Bowel Disease: Phase II - The Impact
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inflammatory Bowel Diseases
Ulcerative Colitis
Crohn Disease
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2021-12-29
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Researchers want to understand if a combination of usual medical care along with a wellness program designed for women with Inflammatory Bowel Disease diagnosis will have an effect on quality of life, stress, and disease activity.

Detailed description: It will take a year to complete the study and involves subjects participating in a Wellness program, wellness coaching and completion of surveys. Subjects will be requested to complete wellness classes along with one wellness coaching session within the first two months of study participation, and continue their year long participation of wellness coaching sessions and surveys.

Eligibility criteria: Inclusion Criteria:

* Female patient with a diagnosis of Ulcerative Colitis or Crohn's Disease seen in the Inflammatory Bowel Disease clinic in the Division of Gastroenterology and Hepatology at Mayo Clinic in Rochester.
* Who are between 18-64 years of age.
* Ability to provide informed consent.
* Ability to complete all aspects of this trial.

Exclusion Criteria:

* Female patients with a diagnosis of Ulcerative Colitis or Crohn's Disease with medical co-morbidity or factor judged by the investigator to preclude participation in the study or which might hinder adherence.
* Participation in another organized wellness program.

Primary outcomes:
measure: Impact of Wellness program on Quality of Life
timeFrame: Baseline day 1 to 12 months end of study
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Laura Raffals, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04445857: Efficacy of Coadministration of Calcitonin and Hyperbaric Bupivacaine in Spinal Anesthesia in Tramadol-abuse Patients
Official title: Efficacy of Coadministration of Calcitonin and Hyperbaric Bupivacaine in Spinal Anesthesia in Lower Abdominal and Limb Surgeries in Tramadol-abuse Patients: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Analgesia
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2020-06-24
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Increasing duration of local anesthetic action is desired for prolongation of postoperative patient comfort, as well as decreasing perioperative opioid consumption and subsequent side effects. Calcitonin, discovered in 1961, has been established, synthesized, and developed for use in treating disease. In 1983 it was demonstrated that calcitonin is an analgesic, which is also effective in the epidural and subarachnoid spaces.Tramadol abuse has dramatically increased in Egypt since 2008 and has led to many admissions to addiction treatment centers.It was shown that the duration of sensory block of spinal anesthesia with hyperbaric bupivacaine in chronic opium abusers undergoing lower extremity orthopedic surgery was much shorter in chronic opium abusers compared with non-abusers.


Eligibility criteria: Inclusion Criteria:

* Patients with history of tramadol addiction (single drug addiction) and duration of addiction \>1 year
* Elective lower abdomen or lower extremities surgeries under spinal anesthesia
* ASA physical status I and II

Exclusion Criteria:

* Patient's refusal,
* duration of surgery more than 120 min,
* obesity with body mass index (BMI) \>35 kg/m2,
* generalized infection or localized infection at level of blockade,
* neurological disease,
* psychological disorder
* coagulation disorder,
* history of uncontrolled hypertension,
* history of uncontrolled blood sugar,
* allergy to bupivacaine or calcitonin

Primary outcomes:
measure: The total dose of rescue analgesia (mg)
timeFrame: The first 24 hours after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain-Shams University Hospitals
Study officials:
References:
Clinical trial NCT03481257: Comparison Between Ticagrelor Versus Very Low Dose Rivaroxaban With Clopidogrel
Official title: Comparison of Shear Stress-induced Thrombotic and Thrombolytic Effect d Thrombolytic Effect Between Ticagrelor Versus Very Low Dose Rivaroxaban With Clopidogrel in Patients With Acute Coronary Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Coronary Syndrome
Acute Myocardial Infarction
Unstable Angina
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2018-03-29
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Fifty-six patients from 452 patients who underwent percutaneous coronary intervention (PCI) due to ACS in Seoul National University Bundang Hospital. ( April 2017\~ January 2018)

Brief summary: A total of 50 participants diagnosed with ACS (group A ticagrelor 180mg/d, n=25), group B (clopidogrel 75mg + rivaroxaban 5mg/ d, n=25)) were consecutively enrolled and treated with study drugs on top of aspirin (100mg/d) for 1 month. VerifyNow® and Global thrombosis test were performed at day 2 and 1 month after administration of study drugs. The investigators compared aspirin reaction unit (ARU) and P2Y12 reaction unit (PRU), occlusion time (OT) which reflects shear stress-induced thrombotic activity, and lysis time (LT) which showed endogenous lytic activity between the two strategies at both time points.


Eligibility criteria: Inclusion Criteria:

* Patients who were diagnosed with acute coronary syndrome and underwent percutaneous coronary intervention

Exclusion Criteria:

* Patients administered with glycoprotein IIb/IIIa inhibitiors
* Patients with atrial fibrillation
* Patients with high risk of bleeding at the physician's discretion
* Patients with renal impairment (estimated GFR \<30ml/min)

Primary outcomes:
measure: Occlusion time
timeFrame: 1 month
Secondary outcomes:
measure: Lysis time
timeFrame: 1 month
measure: Occlusion time
timeFrame: Day 2
measure: Lysis time
timeFrame: Day 2
measure: P2Y12 reaction unit
timeFrame: Day 2 and 1 month
measure: Aspirin reaction unit
timeFrame: Day 2 and 1 month
Other outcomes:
measure: major adverse cardiovascular outcome
timeFrame: 1 month
measure: BARC bleeding
timeFrame: 1 month
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Jung-Won Suh
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01869257: Impact of Triclosan-coated Suture on Surgical Site Infection After Colorectal Surgery
Official title: Impact of Triclosan-coated Suture on Surgical Site Infection After Colorectal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Colorectal Resection
Keywords: triclosan
colorectal
surgery
surgical site infection
Lead sponsor: University of Milano Bicocca
Sponsor class: OTHER
First posted: 2013-06-05
Enrollment: 279
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Despite adequate antimicrobial prophylaxis and perioperative correction of risk factors, surgical site infections (SSI) remain the most frequent complication of colorectal resection (range 10-17%). Several strategies may be implemented to prevent SSI. Among these, the use of local antimicrobial agents seems successful.

The primary aim of the present trial was to evaluate the efficacy of a surgical suture, coated with Triclosan a synthetic soluble antimicrobial agent, in reducing the SSI rate after colorectal operations.

Detailed description: This was a non-sponsored, multicenter, prospective, randomized, controlled, single-blind study. Two hundred and seventy-three patients candidate to colorectal resection were enrolled. Exclusion criteria were: age \< 18 or \> 85 years, pregnancy, peritonitis, peritoneal contamination during operation, ongoing infections, ASA score \> 3, denied consent.

135 were randomized to the treatment arm and 136 to the control arm. Treatment consisted of abdominal wound closure by suturing peritoneum, fascia, subcutaneous tissue, and skin with Polyglactin 910 Triclosan-coated suture (treatment arm) or with Polyglactin without Triclosan (control arm). SSI were defined according to the Atlanta CDC. Patients were followed up by office visits for 30 days after discharge.

Eligibility criteria: Inclusion Criteria:

* patients candidate to elective colorectal resection

Exclusion Criteria:

* no consent
* peritonitis
* hypersensitivity to triclosan
* ASA \> 3
* ongoing infections

Primary outcomes:
measure: Rate of surgical site infection
timeFrame: 30 days
Secondary outcomes:
measure: overall wound complications
timeFrame: 30 days
Other outcomes:
measure: length of hospital stay
timeFrame: 30 days
Locations:
city: Monza
country: Italy
facility: San Gerardo Hospital
Study officials:
affiliation: Milano-Bicocca University
name: Angelo Nespoli, MD
role: STUDY_CHAIR
References:
citation: Chang WK, Srinivasa S, Morton R, Hill AG. Triclosan-impregnated sutures to decrease surgical site infections: systematic review and meta-analysis of randomized trials. Ann Surg. 2012 May;255(5):854-9. doi: 10.1097/SLA.0b013e31824e7005.
Clinical trial NCT02477657: Palliative Care Outcomes in the Management of Malignant Ascites by Interventional Radiology
Official title: Palliative Care Outcomes in the Management of Malignant Ascites by Interventional Radiology
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Refractory Malignant Ascites
Keywords: Adult patients with refractory malignant ascites secondary to GU or GI malignancy.
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2015-06-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients with refractory malignant ascites secondary to GU or GI malignancy.

Brief summary: Malignant ascites leads to significant morbidity in patients with terminal cancer. Paracentesis can provide relief, but repeat hospital visits, pain, and short duration of relief after paracentesis are detrimental to quality of life(QOL). Two devices are available as alternatives to paracentesis. The impact of either device on QOL has not fully been explored. A pilot nonrandomized trial measuring palliative care QOL and ascites symptom relief using validated survey instruments is proposed.


Eligibility criteria: Inclusion Criteria:

* Refractory malignant ascites defined as ascites requiring more than one paracentesis to control patient symptoms despite medical therapy with diuretics and a. peritoneal fluid with cytology positive for malignant cells OR
* Known malignancy with imaging findings of peritoneal carcinomatosis .
* Eastern Cooperative Oncology Group (ECOG) performance score 3
* Age greater than or equal to 18
* Capable of giving informed consent

Exclusion Criteria:

* Life expectancy less than one month
* Coagulopathy defined as international normalized ration (INR) \>2 which cannot be corrected with fresh frozen plasma
* Platelet count \<50,000/microliter, which cannot be corrected with platelet transfusion
* Active skin infections at sites where PVS would be inserted
* Presence of infectious peritonitis or bacteremia
* Neutropenia
* American Heart Association Class D congestive heart failure (ie New York Heart Association Class IV)
* Stage 5 CKD (ie GFR \< 15 mL/min)
* Severe hypoalbuminemia defined as \< 2.2 g/dL
* Loculated or hemorrhagic ascites
* History of bleeding gastroesophageal varices
* Inability to provide informed consent
* Unable to participate in neuropsychological tests / questionnaires
* Pregnant or nursing women
* Anasarca

Primary outcomes:
measure: Number of Adverse Events
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Abramson Cancer Center at Penn Medicine
name: Gregory Nadolski, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00929357: Retrospective Evaluation of the Radiographic Efficacy of Conventional and Biologic Treatment
Official title: A Retrospective Evaluation of the Radiographic Efficacy of Different Conventional Systemic Therapies and Biologics in Patients With Rheumatoid Arthritis in Routine Practice.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-06-29
Enrollment: 156
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: 200

Brief summary: This study involves review and analysis of disease activity in patients with rheumatoid arthritis who where treated with either conventional DMARDs (Disease Modifying Antirheumatic Drugs) or Biologics and have two existing, consecutive radiographs (x-ray images) of hand and feet taken as part of routine treatment monitoring within a time interval of 12 to 36 months.


Eligibility criteria: Inclusion Criteria:

* Secure diagnosis of rheumatoid arthritis
* Older than 18 years
* Two consecutive plain radiographs of the hands and feet with a time interval of 12 to 36 months are available. The radiographs are recorded 2003 or later and are in accordance with a defined X-ray protocol.

Exclusion Criteria:

- Patients who receive Anakinra, Rituximab or Abatacept

Primary outcomes:
measure: Change From Baseline in Joint Status Assessed by Radiographic (Roentgen) Progression
timeFrame: Baseline (Day 0) up to 48 months
Secondary outcomes:
measure: Number of Participants Without Radiographic Progression
timeFrame: Baseline (Day 0) up to 48 months
measure: Number of Participants Without Erosions
timeFrame: Baseline (Day 0) up to 48 months
measure: Change From Baseline in Disease Activity Score Based on 28 Joints (DAS 28)
timeFrame: Baseline (Day 0) up to 48 months
measure: Change From Baseline in Erythrocyte Sedimentation Rate (ESR)
timeFrame: Baseline (Day 0) up to 48 months
measure: Change From Baseline in C-reactive Protein (CRP)
timeFrame: Baseline (Day 0) up to 48 months
measure: Number of Participants With Change From Baseline in Rheumatoid Factor (RF)
timeFrame: Baseline (Day 0) up to 48 months
measure: Number of Participants With Laboratory Result for Cyclic Citrullinated Peptide-autoantibody-test (CCP)
timeFrame: Baseline (Day 0) up to 48 months
Other outcomes:
Locations:
city: Schmittingheide 20-32
country: Denmark
state: Munster
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT03712657: ERAS for Pediatric Acute Appendicitis
Official title: Multi-center Research Manual for the Perioperative Application of Enhanced Recovery After Surgery in Pediatric Acute Appendicitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Disorder
Complicated Appendicitis
Keywords: ERAS
Pediatric surgery
Emergency
Both of systolic and diastolic will be measured
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2018-10-19
Enrollment: 893
Sex: ALL
Minimum age (years): 1
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This multicenter, prospective randomized controlled study is designed to applicate perioperative Enhanced recovery after surgery (ERAS) management for children with acute complicated appendicitis, the aim is to promote postoperative recovery, shorten the hospital length of stay, and reduce the incidence of postoperative complications.

Detailed description: The purpose of this study is through multi-center prospective RCT research, to discuss the application of ERAS in children with acute complicated appendicitis, including its preoperative rehydration, postoperative analgesia, preoperative and postoperative antibiotics application, as well as the discharge standards and so on. The major outcome is whether it can reduce the length of stay in hospital (LOS), secondary outcomes are included the incidence of postoperative complications and postoperative readmission rate, etc.

Eligibility criteria: Inclusion Criteria:

* ages\<14; no gender limitation;
* Alvarado scores ≥7;
* preoperative radiography examination indicated complicated appendicitis;
* Patients or their legal representatives have signed "informed consent"

Exclusion Criteria:

* complicated life-threatening disease;
* perioperative exploration not appendicitis;
* Recently participated in other clinical trials within 3 months;
* Researchers found not fit to participate in this trial for any condition

Primary outcomes:
measure: length of stay
timeFrame: through study completion, an average of 7 days
Secondary outcomes:
measure: first time for postoperative feeding
timeFrame: up to 72 hours
measure: first time for postoperative exercising
timeFrame: 1-2 days
measure: rate of postoperative complication
timeFrame: 1 months
measure: rate of re-operation
timeFrame: 1 months
measure: rate of re-admission
timeFrame: 1 months
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital
state: Hubei
Study officials:
affiliation: Tongji Hospital, HUST, China
name: Jiexiong Feng, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00005457: Model-Free Time Curves for Longitudinal Data Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Heart Diseases
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2000-05-26
Sex: MALE
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: To enhance statistical methods for epidemiological studies by extending the Disturbed Highest Derivative Polynomial (DHDP) to models for binary-logistic and Poisson data and by including random subject effects in the Gaussian model.

Detailed description: DESIGN NARRATIVE:

In previous work the investigator had developed the Disturbed Highest Derivative Polynomial (DHDP) as a model-free time curve and had published the theoretical development for its use as the overall time curve in a linear Gaussian model for longitudinal data with fixed covariate effects and autocorrelated errors but without subject effects. For the logistic model, the DHDP would replace the constant which appeared in the log odds in the non-longitudinal case. The first-order DHDP was a straight line whose slope received random disturbances over time. As such, it was capable of fitting a rich variety of arbitrarily changing time curves. The second-order DHDP would generally provide a fit with smaller high frequency variation. There are a number of longitudinal data analysis methods currently available for Gaussian and binary-logistic data. They all have in common the requirement to explicitly model the overall time curve--usually by a low order deterministic polynomial. The main significance of this proposal was to represent the overall time curve by a DHDP, thereby allowing the possibility for fitting arbitrarily changing time curves without explicitly modeling the form of the change over time. The order of the DHDP can be selected by a modification of the Akaike Information Criterion. The Poisson model should be useful in fitting the periodic reported incidence of a rare disease. The relationship of the DHDP to the Smoothing Polynomial Spline (SPS) was shown and methods were developed for using a SPS instead of a DHDP in analysis. Robustness of the methods were examined by computer simulation studies which evaluated and compared the ability of the DHDP and SPS models to estimate covariate effects and time curves when the time curves were generated by processes other than DHDP.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Cioffi FA, Giammusso V. [Glucocorticoid therapy in head injuries]. Rass Int Clin Ter. 1969 Mar 31;49(6):370-7. No abstract available. Italian.