louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01940224: Evaluation of Preoperative Use of Pregabalin on Postoperative Analgesia After Laparoscopic Colorectal Surgery
Official title: Effectiveness of Preemptive Use of Pregabalin on Pain Intensity and Postoperative Morphine Consumption After Laparoscopic Colorectal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Keywords: Pregabalin
Laparoscopic colorectal surgery
Postoperative pain
Opioid consumption
Lead sponsor: Larissa University Hospital
Sponsor class: OTHER
Collaborators: name: University of Thessaly
First posted: 2013-09-12
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to evaluate how effective is the preoperative administration of pregabalin 300mg, to attenuate postoperative pain and opioids consumption after laparoscopic colorectal surgery

Detailed description: Laparoscopic colorectal surgery has gained wide acceptance because it is associated with reduced pain, lower morbidity, faster recovery and a shorter hospital stay. However, the optimal postoperative pain management method for patients undergoing laparoscopic colorectal surgery is still under evaluation and most of the recommendations are based on studies performed in open approach procedures.

Recently, the analgesic effect of pregabalin, as a part of a multimodal analgesia, has been evaluated in many studies. They have shown that pregabalin may have a role in the post operative pain management, as an adjunct. Pregabalin is an anticonvulsant and anxiolytic drug, which have a more favorable pharmacokinetic profile from its predecessor gabapentin.

Eligibility criteria: Inclusion Criteria:

* ASA physical status I-III
* Patients who undergo laparoscopic colectomy for benign or malignant colorectal disease ( \<Τ3 or =T3 tumors without distant metastasis )

Exclusion Criteria:

* Contraindication for pneumoperitoneum
* Contraindication for laparoscopic approach
* Renal or hepatic insufficiency
* Alcohol or drugs abuse
* History of chronic pain or daily intake of analgesics
* Psychiatric disorders
* Inability of patients to use PCA pump History of intake of non-steroidal anti-inflammatory drugs the last 24 hours before surgery,use of drainage after the surgery

Primary outcomes:
measure: Postoperative opioid consumption
timeFrame: 48 hours
Secondary outcomes:
measure: Postoperative pain
timeFrame: 48 hours
measure: Side- effects
timeFrame: 48 hours
measure: Hospital stay
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 1 week
Other outcomes:
Locations:
city: Larissa
country: Greece
facility: University Hospital of Larissa
Study officials:
affiliation: University Hospital of Larissa
name: Elena Theodorou, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital of Larissa
name: George Tzovaras, MD, PhD
role: STUDY_CHAIR
affiliation: University Hospital of Larissa
name: Georgia Stamatiou, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04805424: Techniques for Abdominoplasty After Massive Weight Loss
Official title: Different Techniques for Abdominoplasty After Massive Weight Loss: Safety and Outcomes
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Skin; Excess
Keywords: Randomized controlled trial
Abdominoplasty
Massive weight loss
Plastic surgery
Liposuction
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
First posted: 2021-03-18
Enrollment: 0
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: Excess skin on the abdomen is a common problem for many individuals after massive weight loss. The surgical procedure of abdominoplasty is intended to remove excess skin and improve the shape of the torso in abdomen, in order to address issues such as skin fold eczema, difficulties finding clothing, and psychosocial issues.

The investigators will conduct a randomized, controlled trial where individuals with excess skin on the abdomen will be randomized to either standard abdominoplasty or abdominoplasty in combination with liposuction. The investigators will examine the rate of complications, and the functional and aesthetical outcomes of the two methods.


Eligibility criteria: This study is open only to individuals who are residents in Sweden and qualify for government-funded, inpatient, non-emergency health care within the Stockholm Region.

Inclusion Criteria:

* BMI \< 30
* Stable BMI for \>= 6 months
* \>= 24 months since bariatric surgery, if applicable
* Skin fold of \>= 5 cm
* Functional and/or psychosocial issues due to abdominal skin excess

Exclusion Criteria:

* Smoking
* Ongoing infection

Primary outcomes:
measure: Number of and type of complications within 30 days
timeFrame: 30 days
Secondary outcomes:
measure: Average need for analgesia in morphine equivalents
timeFrame: Post-operative day 1
measure: Average score on BodyQ score
timeFrame: At baseline, at 3 months post-operatively, at 12 months post-operatively
measure: Average score on aesthetic result
timeFrame: At 12 months post-operatively
measure: Average days until discharge
timeFrame: Days
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Reconstructive Plastic Surgery, Karolinska University Hospital
Study officials:
affiliation: Karolinska University Hospital
name: Ebba Lindqvist, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03302624: Follow-up of Long-term Renal Function After Acute Kidney Injury in ICU
Official title: A Study on the Follow-up of Long-term Renal Function After Acute Kidney Injury in ICU
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Kidney Injuries
Quality of Life
Chronic Kidney Disease
Renal Replacement Therapy
Keywords: acute kidney injury
quality of life
Renal replacement therapy
Intensive care unit
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2017-10-05
Enrollment: 506
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: ICU patients

Brief summary: Acute kidney injury (AKI) involves poor prognosis in ICU patients. The renal prognosis at long term is unknown.

The study will determine chronic kidney injury incidence and quality of life, five years after AK during ICU stay.

Detailed description: Prospective study. All patients who participated ELVIS study (clinical trials: 00875069) can be enrolled in SURIA.

Patients are contacted by telephone. Investigator delivery objective and honest information. If patients accepts the study, answers will be collected.

Collected data are: creatinine serum, two surveys (quality of life and activities of daily living), date of onset of renal replacement therapy.

Eligibility criteria: Inclusion Criteria:

ICU Patients included in ELVIS study, AKI requiring renal replacement therapy Length of ICU stay ≥ 48h

Exclusion Criteria:

Pregnant or nursing woman's job

Primary outcomes:
measure: incidence of chronic kidney disease
timeFrame: 5 years after the first acute kidney injury requiring renal replacement therapy
Secondary outcomes:
measure: severity of CKD according to the International Classification of Chronic Kidney Disease
timeFrame: 5 years after the first acute kidney injury requiring renal replacement therapy
measure: impact of the renal replacement therapy on long-term renal function
timeFrame: 5 years after the first acute kidney injury requiring renal replacement therapy
measure: quality of life
timeFrame: 5 years after the first acute kidney injury requiring renal replacement therapy
measure: Activities of daily living
timeFrame: 5 years after the first acute kidney injury requiring renal replacement therapy
measure: Mortality
timeFrame: 5 years after the first acute kidney injury requiring renal replacement therapy
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Alexandre LAUTRETTE
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02826824: BECOME CHILDREN OF HOLDERS Corpus Callosum Agenesis Screened IN PERIOD Antenatal
Official title: BECOME CHILDREN OF HOLDERS Corpus Callosum Agenesis Screened IN PERIOD Antenatal
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Corpus Callosum Agenesis
Keywords: corpus callosum agenesis
agenesis
corpus callosum
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2016-07-11
Enrollment: 60
Sex: ALL
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The becom of children with agenesis of the corpus callosum detected prenatally in the Alsace-Lorraine region since January 2000

Brief summary: The corpus callosum agenesis is an interesting malformation between 0.05% and 1.5% of the general population. This malformation is mostly diagnosed prenatally by ultrasound, usually at 22 weeks of gestation, and the use of prenatal advice is routinely offered to the couple.

Several studies in recent years have helped to define the determinants of prognosis for the unborn child suffers from agenesis of the corpus callosum, whether total or partial. These, mainly retrospective, demonstrated that the isolated nature of the deformity (defined as no other brain malformations and brain extra, absence of abnormal karyotype, maternal poisoning or viral seroconversion when pregnancy) is associated with favorable developments in terms of psychomotor development in 80% of cases Similar results were also found in prospective studies, while the associated nature of the defect seems most heavily encumber the prognosis as other malformation or syndrome associated with agenesis of the corpus callosum Although these recent data have already significantly influence prenatal counseling and outcome of pregnancy, questions about the future of the child carrying a prenatal diagnosis of agenesis of the corpus callosum are still valid.


Eligibility criteria: Inclusion criteria:

* Children born between January 2000 and January 2013 carrying a corpus callosum agenesis detected prenatally via the multidisciplinary center for prenatal diagnosis (CPDPN) of the Alsace-Lorraine region,
* Children whose holders of parental authority does not oppose the use of clinical data from their child for research purposes

Exclusion criteria:

* Children whose holders of parental authority are opposed to the use of clinical data from their child for research purposes

Primary outcomes:
measure: questionnaire
timeFrame: since January 2000 to january 2016
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Pediatrie 1 - Hopital de Hautepierre
Study officials:
affiliation: University Hospital, Strasbourg, France
name: Vincent LAUGEL, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04126824: Effect of Addition of Steroids on Duration of Analgesia
Official title: Prospective Randomized Controlled Clinical Trial: Superior Hypogastric Nerve Block for Pain Control After Uterine Artery Embolization: Effect of Addition of Steroids on Duration of Analgesia
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: EARLY_PHASE1
Conditions: Uterine Fibroids
Adenomyosis
Keywords: Uterine Artery Embolization
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2019-10-15
Enrollment: 28
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to investigate the differences in post-procedural pain scores and narcotic use among patients who receive a Superior Hypogastric Nerve Block (SHNB) with and without corticosteroid performed as part of the Uterine Artery Embolization (UAE) procedure.

Detailed description: Investigators will enroll a total of 28 women undergoing the UAE procedure with 14 subjects in each study arm. This investigation is a single blind randomized control trial investigating the post-procedural analgesic effect of adding a corticosteroid (Triamcinolone) as an adjuvant to a SHNB that contains bupivacaine for patients undergoing UAE, compared to patients undergoing nerve block for pain control following UAE with local anesthetic only. Before and after the procedure, patients will be asked to complete online surveys in order to record their pain score (measured on the Visual Analog Pain Scale), opioid and other pain medication use, and other symptoms, such as nausea.

Eligibility criteria: Inclusion Criteria:

* females
* aged between 30 and 60 years
* diagnosed with symptomatic uterine fibroids and/or adenomyosis and scheduled to undergo UAE procedure

Exclusion Criteria:

* Contraindications to UAE
* SHNB is deemed unsafe for the patient
* Allergies to local anesthetic or steroid agent
* History of inflammatory bowel disease or ulcerative colitis
* Uncorrectable abnormal coagulation profile
* Diabetes mellitus

Primary outcomes:
measure: Change in Pain Intensity Measure (mm)
timeFrame: Baseline, 240 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Westwood
country: United States
facility: University of California, Los Angeles
state: California
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
Study officials:
affiliation: University of California, Los Angeles
name: Jessica K Stewart, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05411224: Investigation of the Effect of Custom Made Insoles on Foot Pressure Distribution and Gait Parameters in Patients With Morton's Neuroma
Official title: Investigation of the Effect of Custom Made Insoles on Foot Sole Pressure Distribution and Gait Parameters in Patients With Morton's Neuroma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Morton Neuroma
Lead sponsor: Acibadem University
Sponsor class: OTHER
First posted: 2022-06-09
Enrollment: 35
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of our study is to investigate the effect of the use of custom made insoles in the treatment of Morton's neuroma on foot pressure, temporal and spatial gait parameters.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of unilateral Morton neuroma
* Confirmation of the diagnosis of Morton's neuroma with Magnetic Resonance Imaging (MRI)
* Pain level of the patients while walking is at least 3 according to the Visual Analogue Scale (VAS).
* Volunteer to work

Exclusion Criteria:

* Symptomatic musculoskeletal disease in the lower extremity
* Peripheral nervous system disease
* Presence of rigid deformity in the foot
* Extremity or contralateral extremity surgery with Morton's neuroma

Primary outcomes:
measure: Step length (centimeter- cm)
timeFrame: 4weeks
measure: Stance phase percentage (%)
timeFrame: 4 weeks
measure: Swing phase percentage (%)
timeFrame: 4 weeks
measure: Cadance
timeFrame: 4 weeks
measure: Velocity
timeFrame: 4 weeks
measure: Foot pressure distiribution
timeFrame: 4 weeks
measure: Pain - Visual Analogue Scale
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Fulya Foot Surgery
Study officials:
affiliation: Fulya Foot Surgery Clinic
name: Selim Muğrabi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03509324: Effectiveness of Glucose Control, β Cell Function in Response to Short-term Insulin Pump Therapy in Type 2 Diabetes
Official title: Effectiveness and Determinants of Glucose Control, β-cell Function in Response to Short-term Intensive Insulin Pump Therapy in Different Duration of Type 2 Diabetes Mellitus.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2018-04-26
Enrollment: 67
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate and evaluate the significance of intravenous glucose tolerance test in assessment of β-cell function improvement after short course of intensive insulin therapy, trying to illustrate the relationship between fasting plasma glucose and acute insulin release under different stage of type 2 diabetes with poor glycemic control.


Eligibility criteria: Inclusion Criteria: different course of type 2 diabetes with poor glycemic control

-

Exclusion Criteria:

* acute complication or severe comorbidities

Primary outcomes:
measure: fasting plasma glucose after insulin therapy
timeFrame: 10 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: endocrinology department of the first affiliated hospital of Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Ministry of Education
name: Yanbing Li, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00735124: Post-Operative Pain Scores and Analgesic Requirements After Elective Inguinal Herniorrhaphy
Official title: An Investigation of Post-Operative Pain Scores and Analgesic Requirements After Ambulatory Inguinal Herniorrhaphy With Pre-Operative Gabapentin Therapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Pain
Analgesia
Hernia, Inguinal
Keywords: analgesia requirement and post operative pain
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2008-08-14
Enrollment: 5
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: The study will investigate the effects of single dose pre-operative oral dose of gabapentin (1200) on post -operative pain scores and oral analgesic requirements.

Detailed description: The study will benefit patients in reducing post-operative pain scores as well as reduction in oral analgesic consumption. Gabapentin has been shown to reduce post operative pain pain scores in breast surgery, hysterectomy , spinal surgery, orthopedic and thyroid surgery

Eligibility criteria: Inclusion Criteria:

* Subjects having elective surgery with open unilateral Inguinal herniorraphy

Exclusion Criteria:

* Non elective surgery
* Patients currently on gabapentin therapy
* Patient hypersensitive to gabapentin surgery
* History of alcohol or drug abuse
* Patients who are pregnant or who are nursing

Primary outcomes:
measure: Post operative pain is reduced when single pre-operative oral dose of Gabapentine is given to the patient before the Inguinal Herniorrhaphy
timeFrame: 1yrs
Secondary outcomes:
measure: The post operative analgesia requirement is also reduced
timeFrame: 1yrs
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: OUHSC
state: Oklahoma
Study officials:
affiliation: OUHSC
name: Badie Mansour, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00693524: Sequential Therapy (FK506 + Monoclonal Anti-IL2R Antibodies + MMF) Versus FK506 With Steroids in Liver TX
Official title: An Open, Randomized, Multicentre Clinical Study to Compare the Safety and Efficacy of a Combination of Sequential Therapy of Tacrolimus (FK506) With Monoclonal Anti-IL2R Antibodies and Mycophenolate Mofetil Versus Tacrolimus (FK506) With Steroids in Liver Allograft Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Liver Transplantation
Keywords: liver allograft transplantation
sequential therapy
tacrolimus
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2008-06-09
Enrollment: 94
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: Study to evaluate the benefits and any risks of the delayed administration of tacrolimus in a combined regimen of mycophenolate mofetil and monoclonal anti-IL2R antibodies (daclizumab), in comparison with a standard steroid + tacrolimus double drug regimen


Eligibility criteria: Inclusion Criteria:

* Patient is undergoing orthotopic liver allograft transplantation. This includes partial organ transplantation. Age of donor between 5 and 65 years

Exclusion Criteria:

* Patient has previously received or is receiving an organ transplant (including liver re-transplantation)
* Recipient of an auxiliary graft or in which a bio-artificial liver has been used
* Patient is receiving a living related liver transplantation
* Patient is requiring steroids as well as chemotherapy prior to transplantation
* Patient having any previous history of neoplastic disease of any type (including leukaemia). However, patients with primary liver carcinoma can be included if they meet the following criteria:

  * \> 3 nodes
  * No node larger than 5 cm
  * No metastases
  * No vascular invasion

Primary outcomes:
measure: Incidence of first acute rejection
timeFrame: 3 months
Secondary outcomes:
measure: Overall frequences of acute rejection episodes
timeFrame: 3 months
Other outcomes:
Locations:
city: Bologna
country: Italy
city: Genova
country: Italy
city: Milano
country: Italy
city: Napoli
country: Italy
city: Padova
country: Italy
city: Roma
country: Italy
city: Torino
country: Italy
city: Udine
country: Italy
Study officials:
affiliation: Astellas Pharma Europe B.V.
name: Central Contact
role: STUDY_DIRECTOR
References: