louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02605811: Temozolomide in Preventing Brain Metastases in Small Cell Lung Cancer
Official title: Radiation Versus Temozolomide in Preventing Brain Metastases in Limited Stage Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Small Cell Lung Cancer
Metastatic Carcinoma
Keywords: limited small cell lung cancer
brain metastases
prophylactic cranial radiotherapy
temozolomide
Lead sponsor: Guangzhou Medical University
Sponsor class: OTHER
First posted: 2015-11-16
Enrollment: 426
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate the response of temozolomide versus prophylactic cranial radiotherapy in preventing brain metastases in completed or partial remission limited small cell lung cancer patients.

Detailed description: We'd like to investigate the 2-year incidence rate of brain metastases in completed or partial remission limited small cell lung cancer patients who received temozolomide only for 12 months or 25-30Gy prophylactic cranial radiotherapy in preventing brain metastases.

Eligibility criteria: Inclusion Criteria:

1. Histological or cytological diagnosis of small-cll lung cancer histology
2. 18 years or older
3. Eastern Cooperative Oncology Group (ECOG) Performance Status no more than 2
4. Local stage SCLC without distant metastases
5. After 1st-line chemotherapy (EP or IP) at least 4 cycles
6. After radical radiotherapy for primary tumor and lymph node drainage area:including concurrent or sequence chemoradiotherapy
7. CR or PR assessment by RECIST(1.0) before randomized
8. Haemoglobin 10.0 g/dl, Absolute neutrophil count (ANC) 1.5\^9/L, platelets 100 x 10\^9/L
9. Total bilirubin 1.5 x upper limit of normal (ULN) alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< 2.5 x ULN in the absence of liver metastases, or \< 5 x ULN in case of liver metastases
10. Creatinine clearance 60ml/min (calculated according to Cockcroft-gault formula)

Exclusion Criteria:

1. Mixed non-small cell lung cancer histology
2. Neck and supraclavicular lymph node metastasis
3. Be allergic to temozolomide or intolerable to radiotherapy
4. Any unstable systemic disease
5. Pregnant or lactating women

Primary outcomes:
measure: 2-year incidence of brain metastases
timeFrame: 2 year
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The first affiliated hospital of Guangzhou MC
state: Guangdong
Study officials:
affiliation: the first affiliated hospital of Guangzhou MC
name: Hailing Yang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03683511: Nomograms for Optimization of Amikacin First Dose in Critically Ill Patients Using a Population Pharmacokinetics Model
Official title: Population Pharmacokinetics Modeling : a Priori Optimization of Amikacin First Dose in Critically Ill Patients Using a Nomogram
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pharmacokinetics
Keywords: amikacin
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier Universitaire de Nīmes
First posted: 2018-09-25
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated with amikacin for sepsis ou septic shock in the medical intensive care unit of Nantes,France or in an ICU of Nîmes, France will be recruited.

Brief summary: The aim of this study is to elaborate nomograms to optimize amikacine first dosing in critically ill patients, using a population pharmacokinetics model elaborated with multicentric data.

Detailed description: French guidelines recommend for probabilistic therapy to reach an amikacin concentration 1 hour after beginning the infusion ≥ 60 mg/L. This target is rarely achieved in the ICU despite a 30 mg/kg recommended dosage. Using data collected prospectively in critically ill patients of Nîmes (France) (1) and Nantes (France), we will elaborate a population pharmacokinetic model on the non-parametric software Pmetrics and on the parametric software Monolix. We will calculate probability of target attainment of Monte-Carlo simulations, using the non-parametric model. Nomograms to determine optimal first dose of amikacin in critically ill patients, according to a few variables previously identified, will be produced.

Eligibility criteria: Inclusion Criteria:

* patients treated with amikacin for sepsis in one of the participating ICU will be included.

Exclusion Criteria:

* patients with aminoglycoside allergy, history of myasthenia, pregnancy, under guardianship.

Primary outcomes:
measure: amikacin infusion
timeFrame: one hour after beginning of infusion.ed
Secondary outcomes:
measure: maximal dose of amikacin (in mg) allowed to have a probability of target attainment (PTA) of 50% or less for the trough concentration.
timeFrame: 24 hours after beginning of infusion
Other outcomes:
Locations:
city: Nantes
country: France
facility: CHU de Nantes
Study officials:
References:
citation: Roger C, Nucci B, Louart B, Friggeri A, Knani H, Evrard A, Lavigne JP, Allaouchiche B, Lefrant JY, Roberts JA, Muller L. Impact of 30 mg/kg amikacin and 8 mg/kg gentamicin on serum concentrations in critically ill patients with severe sepsis. J Antimicrob Chemother. 2016 Jan;71(1):208-12. doi: 10.1093/jac/dkv291. Epub 2015 Oct 1.
Clinical trial NCT01485211: Corneal Thickness Changes During Corneal Collagen Cross-linking With Ultraviolet-A Irradiation and Riboflavin
Official title: Corneal Thickness Changes During Corneal Collagen Cross-linking With Ultraviolet-A Irradiation and Hypo-osmolar Riboflavin Solution in Thin Corneas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Progressive Keratoconus
Thin Corneas
Keywords: progressive keratoconus
thin corneas
cross-linking
hypo-osmolar riboflavin
Lead sponsor: Instituto de Olhos de Goiania
Sponsor class: OTHER
First posted: 2011-12-05
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the corneal pachymetric variations during and after corneal collagen cross-linking (CXL) treatment with ultraviolet-A irradiation (UVA) and hypo-osmolar riboflavin solution in thin corneas.

Detailed description: To evaluate the corneal pachymetric variations during and after corneal collagen cross-linking (CXL) treatment with ultraviolet-A irradiation (UVA) and hypo-osmolar riboflavin solution in thin corneas.

Eighteen eyes of 18 patients, 11 men and 7 women, with progressive keratoconus and thinnest corneal thickness (TCT) less than 400µm were included in this study.

After the epithelium removal, iso-osmolar riboflavin was applied to the cornea every 3 minutes (30 min). Hipo-osmolar riboflavin was then applied every 20 seconds until the TCT reached 400µm. UVA irradiation was performed for 30 min. Pachymetry was recorded at the thinnest point of the cornea preoperatively, after epithelial removal, after iso-osmolar riboflavin, after hypo-osmolar riboflavin, after UVA irradiation, and at 1, 6 and 12 months.

Eligibility criteria: Inclusion Criteria:

* Progressive Keratoconus
* thin corneas

Exclusion Criteria:

* Contact lens use for less than 3 weeks
* Non progressive keratoconus
* Thinest corneal thickness above 400 micra

Primary outcomes:
measure: Corneal thickness changes during corneal collagen cross-linking with ultraviolet-A irradiation and hypo-osmolar riboflavin solution in thin corneas
timeFrame: Pachymetry was recorded at the thinnest point of the cornea preoperatively, after epithelial removal, after iso-osmolar riboflavin, after hypo-osmolar riboflavin, after UVA irradiation, and at 1, 6 and 12 months.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Instituto de Olhos de Goiania
name: Belquiz A Nassaralla, MD, PhD
role: STUDY_CHAIR
References:
citation: Nassaralla BA, Vieira DM, Machado ML, Figueiredo MN, Nassaralla JJ Jr. Corneal thickness changes during corneal collagen cross-linking with UV-A irradiation and hypo-osmolar riboflavin in thin corneas. Arq Bras Oftalmol. 2013 May-Jun;76(3):155-8. doi: 10.1590/s0004-27492013000300005.
Clinical trial NCT03643211: Xeljanz Special Investigation for Long-term Use in UC Patients
Official title: XELJANZ(REGISTERED) TABLETS 5 MG SPECIAL INVESTIGATION(INVESTIGATION OF LONG-TERM USE IN PATIENTS WITH ULCERATIVE COLITIS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ulcerative Colitis
Keywords: Xeljanz
Ulcerative colitis
UC
Long-term
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2018-08-22
Enrollment: 2016
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: UC patients who were confirmed to have received Xeljanz after the approval date of dosage and administration of Xeljanz for UC patients

Brief summary: Secondary data collection study: safety and effectiveness of Xeljanz in UC patients under Japanese medical practice

Detailed description: This investigation aims to examine the safety and effectiveness of Xeljanz in post-marketing clinical settings when it is administered chronically to patients with ulcerative colitis, based on the approval conditions.

Eligibility criteria: Inclusion Criteria:

* Patients with ulcerative colitis treated with XELJANZ
* Patients naive to XELJANZ in the treatment of ulcerative colitis

Exclusion Criteria:

- None

Primary outcomes:
measure: Number of Participants With Adverse Drug Reactions
timeFrame: 60 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Pfizer Local Country Office
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT00365911: Prevalence of Renal Failure and Risk Factors in an Unreferred Healthy Population
Official title: Prevalence of Renal Failure and Risk Factors in an Unreferred Healthy Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: No specific condition
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: Prevemed-Medibo
name: Medical Laboratory CRI
First posted: 2006-08-18
Enrollment: 2000
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Blood sample is taken for measurement of serum creatinine, cystatin C, clone V haemoglobin, cholesterol, urine acid, glycemia and CRP.

The medical file is gathered. There will be searched for an association between renal function and cardiovascular risk factors and risk factors by exposition to toxic substantia during work.


Eligibility criteria: Inclusion Criteria:

* 20-55 years
* Male and female subjects

Primary outcomes:
measure: A possible association between renal clearance and found cardiovascular risk factors and risk factors by exposition to toxic substantia during work.
timeFrame: At time T0
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Raymond Vanholder, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Ghent
name: Wim Van Biesen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: van der Tol A, Van Biesen W, Verbeke F, De Groote G, Vermeiren F, Eeckhaut K, Vanholder R. Towards a rational screening strategy for albuminuria: results from the unreferred renal insufficiency trial. PLoS One. 2010 Oct 13;5(10):e13328. doi: 10.1371/journal.pone.0013328.
Clinical trial NCT02486211: Amantadine to Speed Awakening After Cardiac Arrest
Official title: Amantadine to Speed Awakening After Cardiac Arrest
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Coma
Heart Arrest
Anoxia
Keywords: heart arrest
resuscitation
seizures
hypothermia, induced
Amantadine
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: American Heart Association
First posted: 2015-07-01
Enrollment: 14
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: This study evaluates if amantadine will increase the rate of awakening in patients resuscitated from cardiac arrest but comatose (not following commands) after their resuscitation. Half of the participants will receive amantadine and the other will receive placebo.

Detailed description: Amantadine has been used to help patients awaken following traumatic brain injury, but it has not been studied in patients with anoxic brain injury.

Amantadine is a dopamine agonist and may help with stimulating the brain to awaken. The investigators will randomize subjects who remain comatose 72 hours following resuscitation from cardiac arrest to either amantadine or placebo. They will be treated with either amantadine or placebo for 7 days.

Eligibility criteria: Inclusion Criteria:

* Non traumatic cardiac arrest
* Age 18 and older
* Defibrillation and/or chest compressions by healthcare providers
* Return of spontaneous circulation

Exclusion Criteria:

* Written do not attempt resuscitation (DNAR) reported to providers before randomization
* Known prisoner or pregnancy
* Lack of motor response to pain and absent N20 response on somatosensory evoked potentials prior to randomization
* Initial CT demonstrating brain edema (defined as grey white ratio \<1.2)
* Presence of malignant pattern on EEG at time of randomization
* Next of kin unwilling to provide supportive care for at least one week after enrollment
* Presently using other dopaminergic agent

Primary outcomes:
measure: Rate of Awakening (Number of Patients Who Are Able to Follow Commands)
timeFrame: up to 28 days
Secondary outcomes:
measure: Time to Awakening
timeFrame: up to 28 days
measure: Seizures (Number of Patients Who Experience Seizures as Detected by EEG Monitoring With or Without Clinical Correlate)
timeFrame: during study drug administration (7 days)
measure: Nausea or Vomiting
timeFrame: during study drug administration (7 days)
measure: Number of Participants With Severe or Intracranial Bleeding
timeFrame: 28 days
Other outcomes:
Locations:
city: Portland
country: United States
facility: Main Medical Center
state: Maine
city: Boston
country: United States
facility: Beth Israel Deacconness
state: Massachusetts
city: Pittsburgh
country: United States
facility: UPMC Presbyterian Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Mercy Hospital
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Jon C Rittenberger, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06485011: Comparison Of Outcome Of Wound Closure After Thyroid Surgery With And Without Platysma Suturing
Official title: Comparison Of Outcome Of Wound Closure After Thyroid Surgery With And Without Platysma Suturing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Acute Postoperative
Keywords: Thyroid surgery
scar
visual analog scale
Lead sponsor: Children Hospital and Institute of Child Health, Lahore
Sponsor class: OTHER
First posted: 2024-07-03
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 groups included
Primary purpose: TREATMENT

Brief summary: Comparison Of Outcome Of Wound Closure After Thyroid Surgery With And Without Platysma Suturing in terms of wound scar and pain.

Detailed description: This randomized controlled trail was conducted at Surgical Ward from January 2021 to July 2021.

Materials and Methods Total 72 patients (indicated for thyroid surgery) who were fulfilling the inclusion criteria were enrolled. Patients were divided randomly into two groups by using lottery method. In Group A patients wound closure was done without Platysma Suturing and in Group-B patients wound closure was done with Platysma Suturing. Pain assessment was done with the help of VAS after surgery (6, Hours, 24 hours, 48 hours). Scar assessment was carried out with the help of POSAS. All this information was noted by the researcher himself and noted on a well-designed questionnaire.

Eligibility criteria: Inclusion Criteria:

* : Both men and women patients in the age range (20-70 years) undergoing primary thyroid surgery were included.

Exclusion Criteria:

* Patients with disorders of wound healing, diabetes mellitus, Pre-operative known malignant condition, history of neck surgery or not willing to participate in the study were excluded.

Primary outcomes:
measure: Post operative Pain
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: The Children Hospital
state: Punjab
Study officials:
affiliation: The Children Hospital
name: Adeel Ashiq, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04186611: Early Occupational Therapy in Intensive Care: Feasibility of Implementation
Official title: Ergothérapie précoce Aux Soins Intensifs: faisabilité d'implémentation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Occupational Therapy
Intensive Care
Lead sponsor: Centre Hospitalier Universitaire Vaudois
Sponsor class: OTHER
First posted: 2019-12-05
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The objective of the study is to assess the feasibility of early daily occupational therapy intervention within an interdisciplinary team in an intensive care unit of a Swiss university hospital.


Eligibility criteria: Inclusion Criteria:

* ≥ 18 years old.
* Hospitalized at SMIA for at least 48 hours.
* Stable patient: hemodynamically stabilized patient (norepinephrine dose \< 15 mcg/min iv), respiratory (P/F ratio \> 150) and neurological (Glasgow Coma Scale \> 8).

Exclusion Criteria:

* contraindication to occupational therapy

Primary outcomes:
measure: Early daily occupational therapy intervention feasability (case report form with questions to ask)
timeFrame: Up to intensive care unit discharge, estimated as an average of 6 days
Secondary outcomes:
measure: Daily occupational therapy intervention description by completion of case report form
timeFrame: Up to intensive care unit discharge, estimated as an average of 6 days
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois
state: Canton De Vaud
Study officials:
References:
Clinical trial NCT00000311: Combining Behavioral Treatment With Agonist Maintenance - 1
Official title: Combining Behavioral Treatment With Agonist Maintenance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cocaine-Related Disorders
Opioid-Related Disorders
Substance-Related Disorders
Keywords: Cocaine-Related Disorders
Opioid-Related Disorders
Substance-Related Disorders
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 1999-09-21
Enrollment: 168
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate whether the community reinforcement approach (CRA) plus contingency management (CM) is more effective overall than CRA only in reducing illicit opioid and cocaine use during agonist maintenance treatment and at 3 and 6 month follow-up after completion of study protocol, and to compare the efficacy of maintenance on buprenorphine to methadone when maintenance is combined with CRA only or CRA plus CM.


Eligibility criteria: Please contact site for information.

Primary outcomes:
measure: Depression
timeFrame: 24 weeks
measure: Withdrawal symptoms
measure: Opioid and cocaine use
measure: Social and psychological functioning
measure: AIDS risk behavior
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: APT Residential Services Division
state: Connecticut
Study officials:
affiliation: Yale University
name: Richard Schottenfeld, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05268211: Diagnostic Performance of Two Tools
Official title: Diagnostic Performance of Two Tools for Early Prediction of Acute Kidney Injury After Open-heart Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Kidney Injury
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-03-07
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Enrollment of patients will be done through Assiut university Heart hospital after approval from the local ethics committee of the Faculty of Medicine, Assiut University

Brief summary: Developing new tools for early detection of AKI in open-heart surgeries.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing on-pump coronary artery bypass graft (CABG) surgery of both sexes

Exclusion Criteria:

* Age less than 18 years old and more than 80 years old. Patients with (CKD), chronic liver disease, heart failure, and not on diuretics or other medications that may affect renal function.

Primary outcomes:
measure: Incidence of acute kidney injury
timeFrame: up to 48 hours
measure: Urinary oxygen partial pressure
timeFrame: up to 48 hours
measure: Renal resistive index
timeFrame: up to 48 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: