louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04978415: Peribulbar Block Versus Subtenon's Injection in Redo Vitreoretinal Surgery
Official title: Comparative Study Between Peribulbar Block Technique and Sub-Tenon's Technique in Adult Patients Undergoing Redo Vitreoretinal Surgery: RCT
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Analgesia
Lead sponsor: Research Institute of Ophthalmology, Egypt
Sponsor class: OTHER
Collaborators: name: Research Institute of Ophthalmology, Egypt
First posted: 2021-07-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: SCREENING

Brief summary: To compare the efficacy and efficiency of peribulbar block versus sub-Tenon's capsule injection of local anesthetic in redo vitreoretinal surgery

Detailed description: Sixty patients undergoing vitreoretinal surgery were randomized to receive either peribulbar or sub-Tenon's capsule injection of 8 ml of a 20:80 mixture of 2% lidocaine and 0.5% bupivacaine with 60 IU hyalouronic acid.

The primary outcome measured was intraoperative eye pain, which was rated by patients in both groups using an 11-point (0-10) numerical visual analogue scale immediately after.

The surgeons indicated whether they perceived patient discomfort during 4 different stages of the operation: opening of the conjunctiva, vitrectomy (if performed), placement of scleral buckle (if performed) or using the laser probe, and closing of the conjunctiva.

The need for supplemental local anesthesia, and use of IV sedation for additional pain control intraoperatively were compared between the two groups.

Eligibility criteria: Inclusion Criteria:

* age between 18 and 80

Exclusion Criteria:

* Uncooperative patients
* Bleeding disorders
* High axial length (30mm) with previous buckle surgery

Primary outcomes:
measure: intraoperative pain
timeFrame: during whole surgery duration (around 2 hours)
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Research Institute of Ophthalmology
Study officials:
affiliation: research institute of ophthalmology
name: Abeer Samir, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03483415: Long Thoracic Nerve Blockade for Pain Treatment After Video-Assisted Thoracoscopic Surgery
Official title: Investigation of Analgesic Effect of Long Thoracic Nerve Blockade After VATS (Video-Assisted Thoracoscopic Surgery) Operation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Nerve Block
Video-Assisted Thoracic Surgery
Lead sponsor: Bursa Yüksek İhtisas Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2018-03-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, randomized, controlled, single-blind
Primary purpose: TREATMENT

Brief summary: Video-assisted thoracoscopic surgery (VATS) provides an opportunity to penetrate the thoracic cavity by video through an incision into the chest wall and facilitate surgical operation of lung pathologies.Various regional methods of anesthesia are currently being used to achieve this goal.

The aim of the study was to assess the effectiveness of Long thoracic nerve bloc on postoperative VATS analgesia.


Eligibility criteria: Inclusion Criteria:

* Patients who were in the American Society of Anesthesiologists (ASA) I-III class and underwent video-assisted thoracoscopic surgery (VATS).

Exclusion Criteria:

* Previous history of opioid use preoperatively,
* Allergy to local anesthetics,
* The presence of any systemic infection,
* Uncontrolled arterial hypertension,
* Uncontrolled diabetes mellitus.

Primary outcomes:
measure: morphine consumption
timeFrame: Postoperative 24 hours
Secondary outcomes:
measure: Visual Analog Scale
timeFrame: Postoperative 24 hours
measure: side effect (Hypotension)
timeFrame: Postoperative 24 hours
measure: additional analgesic use
timeFrame: Postoperative 24 hours
measure: side effect (Nausea and vomiting)
timeFrame: Postoperative 24 hours
measure: side effect (Ramsay Sedation Scale (RSS)
timeFrame: Postoperative 24 hours
Other outcomes:
Locations:
Study officials:
affiliation: UNIVERSITY OF HEALTH SCIENCES BURSA YUKSEK IHTISAS TRAINING AND RESEARCH HOSPITAL
name: Korgün Ökmen, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03162315: The Value of Progesterone for the Timing of the Embryo Transfer in IVF/ICSI: a Prospective Randomised Trial
Official title: The Value of Progesterone for the Timing of the Embryo Transfer in IVF/ICSI: a Prospective Randomised Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Clinical Pregnancy Rate
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2017-05-22
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: At the start of the controlled ovarian stimulation as a part of the IVF/ICSI treatment patients are informed about this trial. In case they gave informed consent and they have a progesterone level between 1 and 1.5 ng/ml at the day of the hCG injection, they will be randomised. One group of patients will have a fresh embryo transfer, in the second group all embryos will be cryopreserved and transfered in a subsequent (natural or artificial) cycle. The aim of this study is to compare clinical pregnancy rate between the two groups.


Eligibility criteria: Inclusion Criteria:

* IVF/ICSI treatment
* progesterone \> 1 ng/ml and ≤ 1.5 ng/ml

Exclusion Criteria:

* \> 40 years
* AMH ≤ 1 ng/ml
* Conditions influencing pregnancy rate (e.g. hydrosalphinx, uterus malformation, hyperprolactinemia and other endocrine conditions; with the exception of controlled thyroid function disease)
* no available progesterone value on the day of hCG-injection

Primary outcomes:
measure: Clinical pregnancy rate
timeFrame: 7 gestational weeks
Secondary outcomes:
measure: Ongoing pregnancy rate
timeFrame: 25 gestational weeks
measure: Live birth rate
timeFrame: Delivery
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University Hospital - Department of Reproductive Medicine
Study officials:
affiliation: University Hospital, Ghent
name: Frank Vandekerckhove, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01848015: Circulating Tumor Cells (CTCs) in Advanced Gastric Cancer
Official title: Prediction of Recurrence in Advanced Gastric Cancer After Radical Resection by Circulating Tumor Cells （CTCs）
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gastric Cancer
Keywords: CTCs before and after gastrectomy
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2013-05-07
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patients with advanced gastric cancer accepted radical resection(D2)

Brief summary: To assess the predictive value of circulating tumor cells (CTCs) for recurrence of advanced gastric cancer after radical resection.

To identify the relationship between the detection of circulation tumor cells and recurrence patterns of gastric cancer after radical resection.


Eligibility criteria: Inclusion Criteria:

* Having signed informed consent
* Age≥ 18 years old
* Histologically confirmed gastric adenocarcinoma
* Preoperative clinical examination and imaging indicating operable disease
* complete resection (R0 resection)
* D2 or D2+ resection

Exclusion Criteria:

* Other tumor type than adenocarcinoma
* Patients who have been given preoperative chemotherapy/chemoradiation.
* Staging investigations or intraoperative exploration indicating inoperable disease
* R1 or R2 resection
* D0 or D1 resection
* Patients unreliable for follow up
* Past history of malignancy

Primary outcomes:
measure: CTCs
timeFrame: 2 months
Secondary outcomes:
measure: Recurrence of gastric cancer after radical resection
timeFrame: 2 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking cancer hospital
state: Beijing
Study officials:
affiliation: Peking University
name: Lin Shen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhang Q, Shan F, Li Z, Gao J, Li Y, Shen L, Ji J, Lu M. A prospective study on the changes and clinical significance of pre-operative and post-operative circulating tumor cells in resectable gastric cancer. J Transl Med. 2018 Jun 20;16(1):171. doi: 10.1186/s12967-018-1544-1.
Clinical trial NCT05729815: Body-oriented Interventions on Preschoolers' Social-emotional Competence
Official title: Effects of Three Body-oriented Intervention Programs on Preschoolers' Social-emotional Competence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Social-emotional Competence
Lead sponsor: University of Évora
Sponsor class: OTHER
First posted: 2023-02-15
Enrollment: 62
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Experimental study with 4 groups (3 experimental and 1 control). Examine the effects of 3 body-oriented intervention programs on preschoolers' social-emotional competence.

Intervention programs focused on relaxation, loose parts play and combined loose parts play and relaxation, for 12 weeks with 2 30-min sessions per week.

Detailed description: To examine the chronic effects of the intervention programs, instruments were collected at baseline (pretest) and at the end of the 12-week period (post-test). To measure the acute effects, salivary cortisol was measured at the beginning and end of the 1st and the 24th sessions.

Eligibility criteria: Inclusion Criteria:

* participants' age between 3 and 6 years
* do not have participated in a similar intervention program within the last 6 months
* do not have a physical condition that can affect the participation in the program.

Exclusion Criteria:

* participants' age less than 3 and under 6 years
* have participated in a similar intervention program within the last 6 months
* have a physical condition that can affect the participation in the program.

Primary outcomes:
measure: Change in Emotion discrimination
timeFrame: 1 and 12 weeks
measure: Change in Emotion identification
timeFrame: 1 and 12 weeks
measure: Change in Emotion recognition
timeFrame: 1 and 12 weeks
measure: Change in Positive and negative emotion expression
timeFrame: 1 and 12 weeks
measure: Change in Self-regulation
timeFrame: 1 and 12 weeks
measure: Change in Stress regulation
timeFrame: 2 days
measure: Change in Social competence
timeFrame: 1 and 12 weeks
measure: Change in Externalizing problems
timeFrame: 1 and 12 weeks
measure: Change in Conflicts resolution
timeFrame: 1 and 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Évora
country: Portugal
facility: Andreia Dias Rodrigues
Study officials:
affiliation: PhD student
name: Andreia D Rodrigues
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00420615: Evaluate the Effects of Patupilone on the Pharmacokinetics of Midazolam and Omeprazole in Patients With Advanced Malignancies
Official title: An Open Label Phase I Study to Evaluate the Effects of Patupilone on the Pharmacokinetics of Midazolam and Omeprazole in Patients With Advanced Malignancies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Solid Tumors
Keywords: Cancer
EPO906
Patupilone
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-01-11
Enrollment: 34
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: The purpose of this study is to evaluate the potential inhibitory effects of patupilone on metabolism using midazolam and omeprazole as the respective probe drugs.


Eligibility criteria: Inclusion criteria:

* Male or female patients 18 years or older
* Histologically documented advanced solid tumor, who have failed standard systemic therapy, or for whom standard systemic therapy does not exist
* Life expectancy of 3 months or more
* Patients with adequate hematologic parameters

Exclusion criteria:

* Hypersensitivity to midazolam or omeprazole or related compounds
* Female patients who are pregnant or breast-feeding.
* Patients with a severe and/or uncontrolled medical disease
* Patients with a known diagnosis of human immunodeficiency virus (HIV) infection
* Patients having received an investigational agent within 30 days prior to study entry

Other protocol defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: To evaluate the effects of patupilone on the pharmacokinetics of midazolam in patients with advanced malignancies.
timeFrame: Day 1 (0.5h, 1h, 1.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h), Day 29 (0.5h, 1h, 1.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h)
measure: To evaluate the effects of patupilone on the pharmacokinetics of omeprazole in patients with advanced malignancies
timeFrame: Day 1 (0.33h (20m), 0.67h (40m), 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h)
Secondary outcomes:
measure: To evaluate the safety and tolerability of Patupilone when administered concomitantly with midazolam in patients with advanced malignancies.
timeFrame: at each visit (week 1, week 2, week 5, and end of study)
measure: To evaluate the safety and tolerability of Patupilone when administered concomitantly with omeprazole in patients with advanced malignancies.
timeFrame: at each visit (week 1, week 2, week 5, and end of study)
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: Novartis Pharmeceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT01502215: Transfusion Requirements in Surgical Oncologic Patient
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Red Blood Cells Transfusion
Oncologic Surgery
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2011-12-30
Enrollment: 198
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Blood transfusion during perioperative period in patients undergoing to major surgery has been associated to several postoperative complications. Particularly in oncologic surgery, red blood cell transfusion has been investigated as a factor of worse outcome and cancer recurrence due to postoperative impairment of cellular immunity. Although red blood cell transfusion has decreased in worldwide clinical practice, this issue still remains a matter of controversy in oncologic surgery. There are no prospective studies comparing outcomes between restrictive or liberal of blood transfusion strategy in oncologic surgery. This study is a prospective and randomized study comparing clinical outcomes between two strategies of transfusion in oncologic surgery - liberal or restrictive


Eligibility criteria: Inclusion Criteria:

* Patients with cancer after major abdominal surgery requiring post-operative ICU admission
* Adults patients

Exclusion Criteria:

* Age less than 18 year
* Hematologic Malignances
* Intensive care unit permanence lower than 24 hours
* Renal Chronic Failure in Renal Replacement Therapy
* Karnofsky Status \< 50
* Previous anemia (hemoglobin lower than 9 g/dL)
* Previous thrombocytopenia (platelet number lower than 50.000/mm3)
* Previous known coagulopathy
* Anticoagulation therapy
* Those unable to receive blood transfusion
* Patients who refused participation in the study

Primary outcomes:
measure: Composite end-point of mortality and severe complication
timeFrame: 30 days
Secondary outcomes:
measure: Hospital Length of Stay
timeFrame: 60 days
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Instituto do Cancer do Estado de Sao Paulo
Study officials:
References:
citation: Carson JL, Stanworth SJ, Dennis JA, Trivella M, Roubinian N, Fergusson DA, Triulzi D, Doree C, Hebert PC. Transfusion thresholds for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2021 Dec 21;12(12):CD002042. doi: 10.1002/14651858.CD002042.pub5.
Clinical trial NCT04927715: Irisin Expression and Gene Polymorphism With Peripartum Cardiomyopathy.
Official title: FDNC5 Genetic Polymorphism in Patients With Peripartum Cardiomyopathy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Peripartum Cardiomyopathy
Keywords: Peripartum Cardiomyopathy, Irisin
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2021-06-16
Enrollment: 45
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: females who have been diagnosed and treated clinically for peripartum cardiomyopathy in our center in sohag university hospital

Brief summary: this is an observertional study aimed at Study the association between the level of irisin expression and (Fibronectin Type III Domain Containing 5 (FDNC5) gene polymorphism in female patients with peripartum cardiomyopathy.


Eligibility criteria: Inclusion Criteria:

* This study will include females aged between 18 and 45 years old who have been diagnosed and treated clinically for peripartum cardiomyopathy

Exclusion Criteria:

* Age less than 18 or more than 45 year old
* females with dilated cardiomyopathy due to other etiology or outside the time frame of occurrence of peripartum cardiomyopathy

Primary outcomes:
measure: Irisin level
timeFrame: 4 months
measure: FNDC5 Genotyping
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag uniersity hosoital
Study officials:
References:
Clinical trial NCT04363515: Pilot Social Support Counseling Intervention for Kidney Transplant Candidates
Official title: Pilot Social Support Counseling Intervention for Kidney Transplant Candidates
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Transplant
Keywords: Interventional Counseling
Kidney Transplant
Interventional Mapping
Counseling
Social Support Networks
Dialysis
Lead sponsor: Hennepin Healthcare Research Institute
Sponsor class: OTHER
Collaborators: name: University of Minnesota
First posted: 2020-04-27
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A control group versus interventional group. Interventional group and their social support network will complete questionnaire.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Feasibility pilot social support counseling intervention for kidney transplant candidates

Detailed description: Individuals who are eligible for kidney transplant will be randomized into two groups, control and interventional counseling. The control group will be given a simple survey to fill and return while the interventional counseling will go through a second counseling session along with members of their social support networks. The interventional counseling will then complete the survey (same as control group). Survey answers will be recorded within REDCAP.

Eligibility criteria: Inclusion Criteria:

* Between ages 18-80
* Being considered for kidney transplant
* Part of social support network for an individual being considered for kidney transplant.
* Physically and Mentally able to participate.

Primary outcomes:
measure: Percentage of Correct Answers on Knowledge of Kidney Transplant Options Assessment
timeFrame: one month
Secondary outcomes:
measure: Difference in Decisional Conflict Scores
timeFrame: one month
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Hennepin Healthcare Research Institute
state: Minnesota
Study officials:
References:
Clinical trial NCT01650415: Erythropoietin Therapy for Children With Cerebral Palsy
Official title: Random Control Trial to Evaluate the Safety and Efficacy of Erythropoietin Therapy for Children With Cerebral Palsy -Patient, Principle Investigator, Observer Blind
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cerebral Palsy
Keywords: Cerebral Palsy
Erythropoietin
Rehabilitation
Lead sponsor: Bundang CHA Hospital
Sponsor class: OTHER
Collaborators: name: LG Life Sciences
First posted: 2012-07-26
Enrollment: 11
Sex: ALL
Minimum age (years): 4
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized placebo-controlled trial aims to investigate the efficacy and safety of erythropoetin for children with cerebral palsy.

Detailed description: Cerebral palsy is a disorder of movement and posture resulted from a nonprogressive lesion or injury of the immature brain. It is a leading cause of childhood onset disability.

Many experimental animal studies have revealed that erythropoietin is useful to repair neurological injury in brain. The main mechanism of erythropoietin is supposed as follows;

1. Neuroprotection effect
2. Angiogenesis
3. Anti-inflammation.

On the basis of many experimental studies, erythropoietin is suggested as a therapeutic method for cerebral palsy.

Eligibility criteria: Inclusion Criteria:

* Cerebral Palsy
* Abnormal Muscle Tone
* Abnormal Brain MRI
* Willing to Comply with All Study Procedure

Exclusion Criteria:

* Known Genetic Disorder
* Other Etiologies Contributing Developmental Delay
* Coagulopathy
* Initial high Erythropoietin level in Serum
* Previous Erythropoietin Treatment before 3 months
* Presence of Drug Hypersensitivity Related to the Study Remedy
* Intractable Seizure Disorder
* Poor Cooperation of Guardian including Inactive Attitude for Rehabilitation

Primary outcomes:
measure: Changes in Quality of Movement
timeFrame: Baseline - 2 months
Secondary outcomes:
measure: Changes in Gross Motor Function
timeFrame: Baseline - 2 months
measure: Changes in Neurodevelopmental Outcomes
timeFrame: Baseline - 2 months
measure: Changes in Motor Development
timeFrame: Baseline - 2 months
measure: Changes in Spasticity
timeFrame: Baseline - 2 months
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: CHA Bundang Medical Center, CHA University
state: Gyeonggi-do
Study officials:
affiliation: CHA University
name: Minyoung Kim, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: