louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05132946: Ultrasound-guided Erector Spinae Plane Block: A Comparative Study to Assess Its Analgesic Efficacy in Pediatric Patients Undergoing Aortic Coarctation Repair
Official title: Ultrasound-guided Erector Spinae Plane Block: A Comparative Study to Assess Its Analgesic Efficacy in Pediatric Patients Undergoing Aortic Coarctation Repair
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anesthesia
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2021-11-24
Enrollment: 40
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will include 40 patients who fulfil all the points in the inclusion and exclusion criteria will be randomized into two equal groups, each consisting of 20 patients, namely group (B) and group (C).

* Group (B): will receive erector spinae plane block.
* Group (C): will not receive any block. Postoperative pain score will be assessed using the FLACC scale or Face, Legs, Activity, Cry, Consolability scale immediately after extubation and at 1, 2, 4, 6, 8, 12, 18, and 24 hours. Routine postoperative analgesia in the form of intravenous paracetamol 7.5 mg/kg/6 hours will be given to all patients (the first dose is given after skin closure). Rescue analgesia in the form of 1 ug/kg fentanyl intravenously for patients if FLACC scale \> 4, and the time for the first rescue analgesic administration will be recorded.


Eligibility criteria: Inclusion Criteria:

* All pediatric patients presented for aortic coarctation repair via left thoracotomy.

Exclusion Criteria:

Hypersensitivity to local anesthetic.

* Mental or neurologic disorders.
* Preoperative critically ill patients.
* Parents or legal guardian refusal.
* Infection at the site of injection.
* Any liver disease.
* Any coagulopathy.

Primary outcomes:
measure: The number of times for usage of fentanyl in postoperative period
timeFrame: in the first 12 hours.
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Samar Soliman
state: Nasr City
Study officials:
References:
Clinical trial NCT01253746: Genetics of Neural Tube Defects
Official title: Genetics of Neural Tubes Defects
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Neural Tube Defects
Keywords: NTD
open NTD
spina bifida
anencephaly
closed NTD
lipomeningocele
tethered cord.
Lead sponsor: John P. Hussman Institute for Human Genomics
Sponsor class: OTHER
Collaborators: name: University of Miami
First posted: 2010-12-03
Enrollment: 6000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: FAMILY_BASED
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any individual with a diagnosis of NTD and his/her selected family members can participate, if willing

Brief summary: The Genetics of Neural Tube Defects Study at the University of Miami: The University of Miami John P. Hussman Institute for Human Genomics is looking for families to participate in research to identify the genetic and environmental factors that contribute to Neural Tube Defects (NTD). Our research goal is to better understand the genetic and environmental causes of both open NTD, like spina bifida and anencephaly, and closed NTD, like lipomeningocele and tethered cord. This will eventually lead to more accurate genetic counseling and risk assessment, improved treatments, and better prevention methods. Any individual with a diagnosis of NTD and his/her selected family members can participate, if willing. Participation is free. Travel is not required. Participation involves reading and signing a consent form, providing a blood sample, a family and medical history interview, and granting the research staff permission to review the medical records of the individual(s) with NTD. We maintain the highest standards of confidentiality for all families. If interested, please contact Maria Ciliberti, the study coordinator, at 1-877-686-6444 (toll free) or directly at 305-243-4360, or by email Mciliberti@med.miami.edu . Please visit our web site at www.hihg.org for more information.


Eligibility criteria: Inclusion Criteria: Any individual with a diagnosis of NTD and his/her selected family members can participate, if willing -

Exclusion Criteria: Pregnant children will not be enrolled

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami John P. Hussman Institute for Human Genomics
state: Florida
Study officials:
affiliation: University of Miami John P. Hussman Institute for Human Genomics
name: Evadnie Rampersaud, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04107246: Data Collection of Therapeutic Compliance in Patients Receiving Corneal Graft Using a Collection Box for Corticosteroid Eye Drops
Official title: Data Collection of Therapeutic Compliance in Patients Receiving Corneal Graft Using a Collection Box for Corticosteroid Eye Drops
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Corneal Graft Disorder (Disorder)
Corticosteroid
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
Collaborators: name: Kali Care
First posted: 2019-09-27
Enrollment: 30
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: Newly transplanted corneal patients and adult

Brief summary: Following corneal graft, local steroids with a gradually decreasing dose for 12 months are prescribed to reduce the graft rejection risk (maximum incidence of 20% for the first 12 months). The validated KaliJAR® device is a box for single-dose eye drops collection. This innovative tool will make it possible to objectify the compliance of patients with a corneal graft.

Unlike the field of glaucoma, no specific compliance data are available for corneal grafts, although it is important because graft rejection is the most important cause of corneal graft failure.


Eligibility criteria: Inclusion Criteria:

* Newly transplanted corneal patients
* Patients able to instill correctly topical corticosteroid treatment
* Patients able to come to control visits
* Patient affiliated or entitled to a social security system
* Patient informed about the study and having signed a consent

Exclusion Criteria:

* Patients under guardianship
* Patients unable to give their consent or to correctly use the collection box

Primary outcomes:
measure: Ratio between the number of instilled drops / number of prescribed drops
timeFrame: 12 months
Secondary outcomes:
measure: patient behaviour towards corticosteroid treatment
timeFrame: 12 months
measure: Questionnaire on therapeutic compliance
timeFrame: month 1, month 6 and month 12
Other outcomes:
Locations:
city: Saint Etienne
country: France
facility: CHU de Saint Etienne
Study officials:
affiliation: CHU de Saint Etienne
name: Philippe GAIN, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00911846: Attitudes Towards Buprenorphine and Methadone
Official title: Attitudes of Patients With Opioid-Substitution and Their Therapists Towards and Buprenorphine and Methadone
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Addictive
Opioids
Keywords: opioid dependence substitution buprenorphine methadone
"substitution"
Lead sponsor: Psychiatric University Hospital, Zurich
Sponsor class: OTHER
First posted: 2009-06-02
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients of therapeutic communities, in- and out-patients and their therapists

Brief summary: Main intention of this study is to find out whether there is a difference between the attitudes towards opioid- substitution of opioid dependent patients under substitution with methadone, buprenorphine or without substitution and their therapists

Detailed description: Attitudes of patients and therapists can influence therapy success in both directions. Not much is known about patients' and their therapists' attitudes towards substitution medication. Our hypothesis is that the attitude towards buprenorphine is more positive than towards methadone even in patients taking methadone. Better knowledge about the influence of attitudes on treatment success could facilitate to adapt therapy to the patients' needs.

Eligibility criteria: Inclusion Criteria:

* Age between 18 and 65 years
* Opioid-dependent with substitution with buprenorphine,
* methadone or without substitution
* Sufficient knowledge of German language

Exclusion Criteria:

* Inability to give informed consent

Primary outcomes:
measure: Attitude toward buprenorphine compared over the four groups
timeFrame: one time of measurement
Secondary outcomes:
measure: Treatment success; Treatment conditions; Consumption of substances
timeFrame: one point of measurement
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Psychiatric University Hospital
state: Kanton Zurich
Study officials:
affiliation: Psychiatric University Hospital, Zurich
name: Lukas Boesch, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT05931146: Effectiveness of Smartphone Application for Weight Loss
Official title: Effectiveness of Smartphone Application for Weight Loss in Healthy Female Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weight Loss
Keywords: Adult Females
Exercise Adherence
Obesity
Physical Activity
VO2 Max
Weight Loss
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2023-07-05
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The aim of this study is

To determine the effectiveness of smartphone application for weight loss in healthy female adults.

To determine the association between fitness application usage and physical activity behavior of the healthy female adults.

Detailed description: Obesity has turned into a significant, rising well-being epidemic around the world. Doing almost no physical work has been connected with chronic weakness results and diminished personal satisfaction in adulthood. It has been perceived that innovation can uphold wellbeing upgrades around the world. The applications that target wellbeing advancement have turned into a focal piece of individuals' lives and have exhibited enormous expansions being used. Proper evidence behind usage of smart phone application for weight loss is sparse and is based on different clinical experiences and a smaller number of studies with limited methodological design. This study will contribute to describing the effectiveness of smartphone application for weight loss in female adults as well as to determine the association between fitness application usage and physical activity behavior.

Eligibility criteria: Inclusion Criteria:

* Adult females
* Age between 18-40 years.
* Individuals with BMI ≥ 25

Exclusion Criteria:

* Pathological conditions affecting any system
* Suffering from recent unhealed MSK injury/Trauma

Primary outcomes:
measure: Weight
timeFrame: 3 months
measure: BMI
timeFrame: 3 months
Secondary outcomes:
measure: MyNetDairy App
timeFrame: 3 months
measure: Level of physical activity
timeFrame: 3 months
measure: Exercise adherence
timeFrame: 3 months
measure: Blood Pressure
timeFrame: 3 months
measure: VO2 max
timeFrame: 3 months
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Riphah International University
state: Federal
Study officials:
affiliation: Riphah International University, Islamabad.
name: Noman Sadiq, MS-SPT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02356146: First Tacrolimus Dose Trough Level is Better Than CYP3A5 Genotyping in Tacrolimus Dose Prediction
Official title: First Tacrolimus Dose Trough Level is Better Than CYP3A5 Genotyping in Tacrolimus Dose Prediction
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Kidney Transplantation Recipients
Keywords: Kidney transplantation
genotype
tacrolimus
CYP3A5
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2015-02-05
Enrollment: 60
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All KT recipient who transplanted and will be transplanted in King Chulalongkorn Memorial Hospital from 2012-2015

Brief summary: Tacrolimus dose highly varies among Asian kidney transplant recipients. This can be explained by variety of CYP3A5 expression. CYP3A5 genotyping is highly recommended for patients receiving tacrolimus. Here, we assessed the tacrolimus dose prediction by comparing CYP3A5 expression and tacrolimus dosage using tacrolimus concentration after single dose administration prior to kidney transplantation.

Plasma tacrolimus trough level was measured at 12 hours after first dose of 0.1 mg/kg of tacrolimus (TacC12), orally administered in 51 new kidney transplant recipients. Patients with CYP3A5 inhibitor/inducer co-medications were excluded. Genotyping for CYP3A5 expression were carried out by RT-PCR. The dosages of tacrolimus at post-operative day 7 and dosage which provided stable therapeutic levels in post-operative month 1 to 3 (C0 5-8 ng/mL) were recorded.

The genotyping, TacC12, and target tacrolimus dosage have good correlations.


Eligibility criteria: Inclusion Criteria:

* All KT recipients

Exclusion Criteria:

* Recipient who not receiving tacrolimus

Primary outcomes:
measure: target tacrolimus dose at 3 months
timeFrame: 3 months
Secondary outcomes:
measure: rate of rejection
timeFrame: 3-12 months
measure: rate of CNI toxicity
timeFrame: 2-12 months
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Chulalongkorn University and King Chulalongkorn Memorial Hospital
Study officials:
affiliation: Chulalongkorn University and King Chulalongkorn Memorial Hospital, Thai Red Cross Society
name: Natavudh Townamchai, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03608046: Avelumab Combined With Cetuximab and Irinotecan for Treatment Refractory Metastatic Colorectal Microsatellite Stable Cancer
Official title: Avelumab Combined With Cetuximab and Irinotecan for Treatment Refractory Metastatic Colorectal Microsatellite Stable Cancer - A Proof of Concept, Open Label Non-randomized Phase IIa Study. The AVETUXIRI Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Colorectal Neoplasms, Malignant
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2018-07-31
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Cancer immunotherapy with immunostimulatory antibodies targeting the CTLA-4 or PD-1/PD-L1 pathways has demonstrated its efficacy in variable proportions of cancer. For metastatic colorectal cancer (mCRC) it appeared that only the small subgroup of patients with MSI-H tumors (microsatellite instability-high phenotype) had a clinically meaningful response to the anti-PD-1- L1 antibodies. In the majority group of non-MSI-H CRC (90-95% of patients), current research expect that additional means would be able to render the tumor "immunogenic" (like MSI-H CRC) and increase the intratumoral immune infiltrate which is the prerequisite to observe a benefit from PD1-PD-L1 inhibitors. Combinations of immune checkpoint inhibitors and procedures that increase intratumoral immune responses, such as targeted therapy, are actively explored.


Eligibility criteria: Inclusion Criteria:

* Age 18 and over, Performance status: ECOG 0-1
* Histologically proven metastatic colorectal adenocarcinoma, refractory to standard chemotherapy (fluoropyrimidine, oxaliplatin, irinotecan) and anti-EGFR treatment (only for RAS WT tumor)
* Measurable disease (RECIST 1.1)
* Metastasis accessible for sequential biopsies
* Patient consent for metastasis biopsies in the study protocol
* BRAF V600E wild-type and MSS tumors
* Adequate normal organ and marrow function (see adequate section of the full protocol for definition)
* Life expectancy of at least 4 months

Exclusion Criteria:

* Concurrent chronic systemic immune therapy, chemotherapy, or hormone therapy that are not indicated in the study protocol
* Systemic autoimmune disease,
* Chronic treatment with corticoids or other immunosuppressive treatment
* Clinically significant cardiac, lung or general disease despite optimal treatment
* Non-progressive disease following irinotecan-based treatment.
* For RAS WT, non-progressive disease following anti-EGFR treatment.

Primary outcomes:
measure: Tumor response rate
timeFrame: Up to 19 weeks
Secondary outcomes:
measure: Adverse events
timeFrame: Up to 19 weeks
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint-Luc
city: Charleroi
country: Belgium
facility: Grand Hôpital de Charleroi
Study officials:
References:
Clinical trial NCT00334646: Cyclophosphamide Drug Interaction Study In Cancer Patients
Official title: An Open Label, Repeat Dose, Randomized, Two Period Crossover Study to Investigate the Potential Pharmacokinetic Interactions Between Oral GW679769 and Intravenous Cyclophosphamide in Cancer Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Nausea and Vomiting, Chemotherapy-Induced
Keywords: cyclophosphamide
CINV
Chemotherapy induced nausea and vomiting
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-06-08
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study is designed to evaluate the potential pharmacokinetic interaction between oral GW679769 and IV (intravenous) cyclophosphamide when administered to cancer patients.


Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of cancer.
* Undergoing chemotherapy with a cyclophosphamide regimen with a cyclophosphamide dose of 500 - 700 mg/m2 and a cycle duration of 14-28 days.
* Adequate hematologic, renal and hepatic function.

Exclusion Criteria:

* Pregnant or lactating.
* CNS (central nervous system) metastases.
* Active systemic infection or any other poorly controlled medical condition.
* Patients cannot take CYP3A4 inhibitors within 7 days of study treatment or CYP3A4 inducers within 48 days of study treatment.

Primary outcomes:
measure: Cmax and AUC of cyclophosphamide and 4-hydroxycyclophosphamideSafety and tolerability parameters including pharmacoeconomics, blood pressure, heart rate, ECG, laboratory tests, clinical observation and adverse event reporting.
timeFrame: throughout the study
Secondary outcomes:
measure: Terminal t1/2, Vd, and Cl of cyclophosphamideTerminal t1/2 of 4-hydroxycyclophosphamideAUC ratio of 4-hydroxycyclophosphamide and cyclophosphamideANC nadir
timeFrame: throughout the study
Other outcomes:
Locations:
city: Newark
country: United States
facility: GSK Investigational Site
state: Delaware
city: Albuquerque
country: United States
facility: GSK Investigational Site
state: New Mexico
city: Bronx
country: United States
facility: GSK Investigational Site
state: New York
city: Christchurch
country: New Zealand
facility: GSK Investigational Site
city: Lund
country: Sweden
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT02094846: Evaluation of an Intervention Based on Cell Phones
Official title: Evaluation of the Effect of an Intervention Based on Cell Phones on Glycemic Control in Adults With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Keywords: Cellular phones
Type 2 diabetes
Glycated hemoglobin
glycemic control
Lead sponsor: Instituto Nacional de Salud Publica, Mexico
Sponsor class: OTHER
First posted: 2014-03-24
Enrollment: 88
Sex: ALL
Minimum age (years): 30
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study was to assess the effect of an individualized intervention based on cell phones to improve glycemic control in patients with type 2 diabetes attending Epidemiology Research Unit in Cuernavaca, Morelos. Mexico

Detailed description: In this study before randomization, the participants received workshops on diet, physical activity, glycemic index of foods.

Bandura´s theoretical model was used in the voice messages sent to the intervention group.

Eligibility criteria: Inclusion Criteria:

* type 2 diabetes mellitus \> 10 years
* Glycated hemoglobin \>7%

Exclusion Criteria:

* Take insulin regularly
* Pregnant woman
* Woman who expected to be pregnant the next 6 months
* 24 hrs creatinine \< 30 ml/minute

Primary outcomes:
measure: Glycated hemoglobin
timeFrame: Basal and 3 months
Secondary outcomes:
measure: Low Density Lipoprotein
timeFrame: Basal and 3 months
measure: High Density Lipoprotein
timeFrame: Basal and 3 months
measure: Cholesterol
timeFrame: Basal and 3 months
measure: Self-efficacy
timeFrame: Basal and 3 months
measure: Physical activity
timeFrame: Basal and 3 months
Other outcomes:
Locations:
city: Cuernavaca
country: Mexico
facility: Unidad de Investigación en Epidemiología y Servicios de Salud del Instituto Mexicano del Seguro Social
state: Morelos
Study officials:
affiliation: Instituto Nacional de Salud Pública
name: Mario E Flores Aldanda, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Oh JA, Kim HS, Yoon KH, Choi ES. A telephone-delivered intervention to improve glycemic control in type 2 diabetic patients. Yonsei Med J. 2003 Feb;44(1):1-8. doi: 10.3349/ymj.2003.44.1.1.
citation: Liang X, Wang Q, Yang X, Cao J, Chen J, Mo X, Huang J, Wang L, Gu D. Effect of mobile phone intervention for diabetes on glycaemic control: a meta-analysis. Diabet Med. 2011 Apr;28(4):455-63. doi: 10.1111/j.1464-5491.2010.03180.x.
citation: Cole-Lewis H, Kershaw T. Text messaging as a tool for behavior change in disease prevention and management. Epidemiol Rev. 2010;32(1):56-69. doi: 10.1093/epirev/mxq004. Epub 2010 Mar 30.