louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01394744: Determination of Metal Ion Serum Levels and Cytokines in Total Hip Replacement
Official title: Determination of Metal Ion Levels in the Serum and Assessment of the Respective Cytokine Production of Peripheral Blood Cells in Patients With a Hard-on-hard Bearing Total Hip Replacement
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hip Replacement Arthroplasty
Keywords: metal
ion
cytokine
hip arthroplasty
blood
Assessment
cytokine profile
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
Collaborators: name: ARCUS-Sportklinik
name: DePuy Orthopaedics
First posted: 2011-07-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: total of 30 subjects; 10 with metal-on-metal, 10 with ceramic-on-ceramic and 10 with ceramic-on-metal hip replacement;

Brief summary: The goal of the study is the analysis of metal ion serum concentrations and of the cytokine production in the blood of patients with a conventional cementless total hip replacement. The rationale is that a) the bearing wear releases particles respectively metal ions into the joint and the blood which will differ in quantity and composition; b) the cytokine production of peripheral blood mononuclear cells (PBMC) might be influenced to a varying degree by the metal and the ceramic particles.

The patients from whom the respective samples will be analyzed are randomized in one of the following three groups: metal-on-metal, ceramic-on-ceramic or ceramic-on-metal. A 36mm bearing is used in all patients. In this separate study, follow-up data of the clinical and radiographic examinations of the patients are available.


Eligibility criteria: Inclusion Criteria:

* age over 18 years, necessity of hip replacement, informed consent

Exclusion Criteria:

* acute inflammatory disease, renal disease, other cobalt-chromium implant, ager over 75 years

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Ludwig-Maximilians-University Munich, Dept. of Dermatology
state: Bavaria
city: Pforzheim
country: Germany
facility: ARCUS Sportklinik
Study officials:
affiliation: Ludwig-Maximilans-University
name: Peter Thomas, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02235844: Allogeneic Human Umbilical Cord Mesenchymal Stem Cells for a Single Male Patient With Duchenne Muscular Dystrophy (DMD)
Official title: Allogeneic Transplantation of Human Umbilical Cord Mesenchymal Stem Cells (UC-MSC) for a Single Male Patient With Duchenne Muscular Dystrophy (DMD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Duchenne's Muscular Dystrophy
Keywords: Mesenchymal
Stem Cells
Umbilical Cord
Duchenne's
Muscular Dystrophy
Lead sponsor: Allergy and Asthma Consultants, Wichita, Kansas
Sponsor class: OTHER
Collaborators: name: Aidan Foundation
name: Neil H. Riordan PhD
First posted: 2014-09-10
Enrollment: 1
Sex: MALE
Minimum age (years): 28
Maximum age (years): 31
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This research study is designed to evaluate the effects of human umbilical cord mesenchymal stem cells (UC-MSCs), on Duchenne's muscular dystrophy (DMD). The potential muscle regenerative and anti-inflammatory properties of UC MSCs position them as a possible treatment option for DMD. Both of these properties could lead to potential benefits for a DMD patient.


Eligibility criteria: Inclusion Criteria:

* Duchenne's Muscular Dystrophy

Exclusion Criteria:

* None

Primary outcomes:
measure: Adverse Events
timeFrame: 3 months after final treatment
Secondary outcomes:
measure: Change from baseline of weight
timeFrame: 3 months after final treatment
measure: Change of muscle diameter (circumferential measurements) from baseline
timeFrame: 3 months after final treatment
measure: Change from baseline of Pulmonary Maximum Expiratory Pressure
timeFrame: 3 months after final treatment
measure: Change from baseline of Pulmonary Forced Vital Capacity
timeFrame: 3 months after final treatment
measure: Maximum Change from baseline of Predicted Inspiratory Pressure %
timeFrame: 3 months after final treatment
measure: Change from baseline of Predicted Maximum Expiratory Pressure %
timeFrame: 3 months after final treatment
measure: Change from baseline of Predicted Forced Vital Capacity %
timeFrame: 3 months after final treatment
Other outcomes:
Locations:
city: Wichita
country: United States
facility: Asthma and Allergy Consultants
state: Kansas
Study officials:
affiliation: Allergy and Asthma Consultants of Wichita, KS
name: Maurice HV Strickland, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03884244: Postoperative Chewing Gum and Gynecological Laparoscopic Surgery
Official title: The Effect of Postoperative Chewing Gum on Intestinal Functions After Gynecological Laparoscopic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gynecologic Disease
Postoperative Ileus
Paralytic Ileus
Keywords: Laparoscopic Surgery
Postoperative Bowel Function
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
First posted: 2019-03-21
Enrollment: 200
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The authors aimed to evaluate the effects of postoperative gum chewing on laparoscopic gynecological surgery, gastrointestinal function-intestinal mobility and early postoperative recovery. Patients undergoing elective gynecological laparoscopy were randomized. Demographic and characteristic features of the patients were recorded. Operation type, operation and anesthesia information were recorded. Patients underwent a postoperative routine regimen. Starting from the sixth hour, the sugar-free gum was crushed every 15 minutes until the gas was released. Postoperative follow-up was performed routinely. The first bowel movements, first bowel movements and first gas extraction and first decongestation periods were recorded.

Detailed description: The team of the research team of the research team will listen and record the bowel sounds of the patients, using a stethoscope every two hours starting from the postoperative 3rd hour until the first bowel sounds are heard in each patient.

Patients who were able to tolerate patients starting from the 8th hour after the surgery were allowed for mobilization. Also, they were allowed to take fluid regimen from the postoperative 12th hour. Patient satisfaction was evaluated by using visual analogue scale (VAS) on the day of discharge on chewing postoperative.

The primary index for the return of GI functions was the first gas removal time. Secondary index was the time of first bowel sound, the first time of admission, hospitalization time and the presence of postoperative ileus.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing elective laparoscopic gynecological surgery.

Exclusion Criteria:

* Those who have been operated for malignant reasons,
* Those who underwent emergency surgery,
* Who could not chew gum,
* Who had serious surgical complications (postoperative intraabdominal hemorrhage, infection, peritonitis),
* Who had a history of gastrointestinal disease,
* Secondary laparotomy.

Primary outcomes:
measure: Postoperative Bowel Functions
timeFrame: Postoperative first 1440 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Pınar Kadiroğulları
Study officials:
References:
Clinical trial NCT04422444: Post Intensive Care Syndrome in COVID19 Patients
Official title: Characterization and Management of Post Intensive Care Syndrome in COVID19 Patients.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID19
Post Intensive Care Unit Syndrome
Lead sponsor: Corporacion Parc Tauli
Sponsor class: OTHER
First posted: 2020-06-09
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ICU patients with COVID19

Brief summary: This project is based in the implementation of a combined monitoring system (technological solutions and medical visits) in survivors of the critical illness due to the infectious disease by COVID-19. The main objective of the project is to characterize the Post-Intensive Care Syndrome (PICS) and detect early needs for specific treatment.


Eligibility criteria: Inclusion Criteria:

* Patients admitted to ICU for COVID 19

Exclusion Criteria:

* Mental health diagnosis previous to the COVID19 infection
* Acquired brain damage or neurological disease previous to the COVID19 infection

Primary outcomes:
measure: Change from baseline Short Form 12 Health Survey (SF12) at 12 month
timeFrame: Every month during a 12 months follow-up period
Secondary outcomes:
measure: Change from baseline Lawton & Brody Instrumental activities of daily living scale at 12 months
timeFrame: Every month during a 12 months follow-up period
measure: Change from baseline Perceived Deficits Questionnaire (PDQ) at 12 months
timeFrame: Every month during a 12 months follow-up period
measure: Change from baseline Hospital Anxiety and Depression Scale (HADS) at 12 months
timeFrame: Every month during a 12 months follow-up period
measure: Change from baseline Davidson Trauma Scale (DTS) at 12 months
timeFrame: Every month during a 12 months follow-up period. Values are from 0 to 136, with lower scores meaning better outcome.
Other outcomes:
Locations:
city: Sabadell
country: Spain
facility: Corporació Parc Taulí
state: Barcelona
Study officials:
affiliation: Institut d'Investigació i Innovació Parc Taulí (I3PT)
name: SOL FERNANDEZ, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00245544: Safety and Preliminary Efficacy of MK0759 in Postherpetic Neuralgia (PHN)(0759-004)
Official title: A Randomized, Double-Blind, Placebo-Controlled, Two-Period Crossover Study to Explore the Safety and Preliminary Efficacy of Oral MK0759 in the Treatment of Postherpetic Neuralgia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Neuralgia, Postherpetic
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2005-10-28
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test the safety and effect of MK0759 in relieving neuropathic pain as experienced by patients with postherpetic neuralgia (PHN).


Eligibility criteria: Inclusion Criteria:

* Age 18 to 85; diagnosis of postherpetic neuralgia with pain having persisted at least 6 months; dissatisfied with current regimen of pain control; able to complete study questionnaires, patient diary, and comply with daily study medication

Exclusion Criteria:

* Women of childbearing potential; history or evidence of a condition that, in the opinion of the investigator, may interfere with the study interpretation (e.g., diabetic neuropathy or fibromyalgia) or pose undue risk to undergo the course of medication required by the study (e.g., unstable heart disease, morbid obesity, kidney or liver disease).

Primary outcomes:
measure: Pain intensity recorded by the patient each evening using an 11-point Likert scale (0=no pain to 10=pain as bad as you can imagine).
timeFrame: Duration of Treatment
Secondary outcomes:
measure: Safety; Patient Global Impression of Change assessed at the end of each treatment period.
timeFrame: Duration of Treatment
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT03145844: Direct Acting Agents in Hepatitis C Patients
Official title: Evaluation of Efficacy and Safety of Direct Acting Agents in Hepatitis C Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C
Hepatitis C Relapse
Hepatitis C Recurrent
Keywords: DAA
Hepatitis
Lead sponsor: Viral Hepatitis Society
Sponsor class: OTHER
Collaborators: name: Viral Hepatitis Society
First posted: 2017-05-09
Enrollment: 2700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients diagnosed as Hepatitis C and used direct acting agents.

Brief summary: This study is a retrospective study conducted at 36 sites. Planned target patient number is 1000.

Detailed description: Approximately 36 centers will be included in Turkey. Centers will be selected from clinics of infection and clinical microbiology. The inclusion of 1000 patients was targeted. All data will be retrospectively collected from the medical records of the patients. Patient visit is not necessary.

Eligibility criteria: Inclusion Criteria:

* Patients who used direct acting agents for Hepatitis C

Exclusion Criteria:

* Patients younger then 18 years

Primary outcomes:
measure: Disease management with direct acting agents
timeFrame: Beginning of treatment - 12 weeks after the treatment ended (36 weeks)
Secondary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: Up to 48 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Cerrahpasa Medical Faculty
Study officials:
affiliation: Viral Hepatitis Society
name: Fehmi Tabak, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Viral Hepatitis Society
name: Tansu Yamazhan, Prof
role: STUDY_DIRECTOR
References:
Clinical trial NCT02802644: The Effect of DPP4 Inhibitor on Vasclular Healing
Official title: A Prospective, Multi-center, Randomized, Controlled Study to Evaluate the Effect of DiPeptidyl-Peptidase 4 Inhibitor on Vascular Healing After Biodegradable Polymer Based Sirolimus Eluting Stent Implantation in Diabetic Patients: OCT Study (DIAMOND-OCT)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Acute Coronary Syndrome
Diabetes Mellitus, Type 2
Lead sponsor: Chung-Ang University
Sponsor class: OTHER
First posted: 2016-06-16
Enrollment: 66
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluate the effect of dipeptidyl-peptidase 4 inhibitor on vascular healing after biodegradable polymer based sirolimus eluting stent implantation in diabetic pateints.


Eligibility criteria: Inclusion Criteria:

* Non-ST segement elevation acute coronary syndrome

Exclusion Criteria:

* Left main disease
* Known hypersensitivity or contraindication to any of the following medications: Heparin, aspirin, clopidogrel, sirolimus, siptagliptin and statin
* Congestive heart failure (patients with LVEF \<30% or cardiogenic shock)
* Uncontrolled myocardial ischemia (repeated chest pain or dyspnea after revascularization)
* Uncontrolled ventricular arrhythmia
* History of malignancy with chemotherapy
* Serious hematologic disease (e.g. CML, MDS)
* Current infectious disease needs antibiotics therapy
* Creatinine level \>1.5 mg/dL or dependence on dialysis
* Other severe concurrent illness (e.g. active infection, malignancy).
* Life expectancy of less than one year
* Pregnancy or women with potential childbearing
* Type I DM
* Treatment with insulin
* History of pancreatitis
* Who cannot read the informed consent form (e.g. illiteracy, foreigner)

Primary outcomes:
measure: Neointimal coverage assessed by optical coherence tomography
timeFrame: 6 months
Secondary outcomes:
measure: Malapposition, neointimal thickness or any optical coherence tomographic finding
timeFrame: 6 months
measure: Biomarkers
timeFrame: 6 months
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Keimyung University Hospital
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Jeju
country: Korea, Republic of
facility: Jeju National University Hospital
city: Seoul
country: Korea, Republic of
facility: Chung-Ang University Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
Study officials:
affiliation: Chung-Ang University Hosptial, Chung-Ang University College of Medicine
name: Sang-Wook Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02918344: Complications From the Use of Calcium Phosphate Paste in Mandibular Lengthening Osteotomies
Official title: Prospective Study: Complications From the Use of Calcium Phosphate Paste in Mandibular Lengthening Osteotomies
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Jaw Anomalies
Infection
Keywords: calcium phosphate paste
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2016-09-28
Enrollment: 192
Sex: ALL
Minimum age (years): 15
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing bilateral sagittal split osteotomy

Brief summary: The goal of this study is to determine if the use of calcium phosphate paste in mandibular lengthening surgery causes more complications as surgical site infections and hardware removal.

An evaluation will be made to determine if the benefits of the use of the paste (3D-stability, prevention of early relapse and unaesthetic indentation) outweighs the disadvantages.

Detailed description: The sagittal split osteotomy (SSO) is commonly used to correct dentofacial discrepancies. Correction of distocclusion can be achieved through lengthening of the mandible, and a balanced facial appearance can be obtained by increasing chin projection.

Calcium phosphate paste is used in mandibular lengthening surgery to avoid an unaesthetic notching at the lower border(1)(2) and to help stabilize the segments when osteosynthesis slippage is feared for. A recently performed retrospective study showed an increase of infectious complications when calcium phosphate paste was used for this indications. Several precautions were identified that could be undertaken to decrease the infectious complications. The study concluded that a prospective study was required in which these precautions were implemented to determine whether infectious complications can be reduced.

The aim of this study is to investigate whether the hardened paste still increases the incidence of site infections after implementation of several precautions and the use of a standardized antibiotic prophylactic protocol.

Eligibility criteria: Inclusion Criteria:

* All patients with dysgnatic deformities requiring mandibular lengthening surgery
* Gender: M/F
* Age: \>15y-75y

Exclusion Criteria:

* Previous orthognathic surgery
* Congenital facial malformations
* Unilateral SSO
* Immunodeficiency
* Simultaneous removal of lower third molars
* Incomplete postoperative follow-up

Primary outcomes:
measure: Surgical site infection
timeFrame: 6 months
Secondary outcomes:
measure: Hardware removal
timeFrame: 6 months
measure: Revision
timeFrame: 6 months
Other outcomes:
Locations:
city: Jette
country: Belgium
facility: universitair Ziekenhuis brussel
state: Brussels
Study officials:
affiliation: Universitair Ziekenhuis Brussel
name: Erica Coppey, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitair Ziekenhuis Brussel
name: Maurice Mommaerts, Prof.Dr.Mult
role: STUDY_DIRECTOR
References:
Clinical trial NCT04648644: Application of ERAS Protocol in Emergency Surgery
Official title: Application of ERAS Protocol in Emergency Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Enhanced Recovery After Surgery
Emergency Surgery
Lead sponsor: University of Milano Bicocca
Sponsor class: OTHER
First posted: 2020-12-01
Enrollment: 589
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: All patients undergoing emergency surgery for abdominal sepsis or occlusion and treated with bowel resection with or without anastomosis, intestinal bypass or adhesiolysis.

Brief summary: This study defines a standardized protocol inspired to the ERAS philosophy for the peri-operative treatment of patients undergoing emergency abdominal surgery. Primary endpoint is the feasibility of the application of the standardized protocol; secondary endpoint is the safety


Eligibility criteria: Inclusion Criteria:

* patients undergoing emergency abdominal surgery for abdominal sepsis or occlusion and treated with bowel resection with or without anastomosis, intestinal bypass or adhesiolysis.

Exclusion Criteria:

* age \<18
* emergency surgery for post-operative complications of post diagnostic procedures

Primary outcomes:
measure: Feasibility: % of application of post-operative ERAS items
timeFrame: 30 days
Secondary outcomes:
measure: Safety: complications rate within 30 days
timeFrame: 30 days
Other outcomes:
Locations:
city: Lecco
country: Italy
facility: Ospedale Manzoni
state: LC
city: Monza
country: Italy
facility: ASST Monza
state: MB
city: Milano
country: Italy
facility: Ospedale San Raffaele
state: Mi
city: Lodi
country: Italy
facility: ASST Lodi
city: Pisa
country: Italy
facility: Azienda ospedaliero-universitaria Pisana,Ospedale Cisanello
city: Pistoia
country: Italy
facility: Ospedale San Jacopo
city: Roma
country: Italy
facility: Policlinico Gemelli
city: Trieste
country: Italy
facility: Ospedale di Cattinara
Study officials:
affiliation: University of Milano Bicocca
name: Marco Braga, MD
role: PRINCIPAL_INVESTIGATOR
References: