louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00283543: Radiation With Concomitant and Then Sequential Temozolomide in Malignant Glioma
Official title: A Phase II Study of Radiation With Concomitant and Then Sequential Temozolomide in Patients With Newly Diagnosed Supratentorial Malignant Glioma Who Have Undergone Surgery With Gliadel Wafer Insertion
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Newly Diagnosed Supratentorial Malignant Glioma
Keywords: Glioma
Gliadel Wafer
Lead sponsor: Kentuckiana Cancer Institute
Sponsor class: OTHER
Collaborators: name: Eisai Inc.
First posted: 2006-01-30
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 72
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To determine the safety and efficacy of Gliadel 3.85% wafers plus surgery and radiation with Temozolomide

Detailed description: A phase II study of radiation with concomitant and then sequential Temozolomide in patients with newly diagnosed supratentorial malignant glioma who have undergone surgery with Gliadel wafer insertion. To determine the safety and efficacy of Gliadel 3.85% wafers plus surgery and limited field radiation therapy with concomitant Temozolomide followed by Temozolomide alone in patients undergoing initial surgery for newly diagnosed unifocal moderate to high grade glioma.

Eligibility criteria: Inclusion Criteria:

* MRI showing unilateral supratentorial cerebral tumor
* surgical tx within 4 weeks of baseline MRI
* KPS 60% or higher
* moderate to high grade malignant glioma

Exclusion Criteria:

* prior cytoreductive surgery for moderate or high grade glioma
* prior CNS radiotherapy
* prior chemo for this glioma
* more than one focus of tumor or tumor crossing the midline per MRI
* life expectancy less than 12 months
* sensitivity to temozolomide, nitrosoureas, or Gliadel wafer

Primary outcomes:
measure: To determine the safety and efficacy of Gliadel 3.85% wafers
Secondary outcomes:
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Kentuckiana Cancer Institute
state: Kentucky
Study officials:
affiliation: Kentuckiana Cancer Institute
name: Renato V. LaRocca, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01878643: Reduction of Bacterial Resistance With Inhaled Antibiotics in the Intensive Care Unit
Official title: Pilot Study of the Effects of Inhaled Antibiotic on Bacterial Resistance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Respiratory Infection
Bacterial Resistance
Respiratory Failure
Keywords: aerosolized antibiotic
ventilator-associated pneumonia
bacterial resistance
ventilator -associated tracheobronchitis
clinical pulmonary infection score
Lead sponsor: Stony Brook University
Sponsor class: OTHER
First posted: 2013-06-17
Enrollment: 47
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 was :

* to determine the effect of inhaled antibiotics on airway bacteria in ventilated patients
* to determine the effect of inhaled antibiotics on respiratory infection

Detailed description: Double-blind randomized placebo controlled study examining the effect of aerosolized antibiotics on respiratory infection signs and symptoms and on bacterial eradication and resistance.

Systemic antibiotics are administered by the responsible physician

Eligibility criteria: Inclusion Criteria:

* be on mechanical ventilation greater than 3 days
* greater than or equal to 18 years and survival greater than 14 days
* organisms on Gram stain with increasing purulent secretions

Exclusion Criteria:

* pregnancy
* allergy to drugs administered

Primary outcomes:
measure: Eradication of multi-drug resistant bacteria
timeFrame: Randomization and at end of treatment
Secondary outcomes:
measure: Clinical Pulmonary Infection Score (CPIS)
timeFrame: Randomization and at end of treatment which is defined as 14 days or at time of extubation, which ever comes first.
Other outcomes:
Locations:
city: STony Brook
country: United States
facility: University Hospital Medical Center
state: New York
Study officials:
affiliation: Stony Brook University
name: Lucy B Palmer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Palmer LB, Smaldone GC. Reduction of bacterial resistance with inhaled antibiotics in the intensive care unit. Am J Respir Crit Care Med. 2014 May 15;189(10):1225-33. doi: 10.1164/rccm.201312-2161OC.
Clinical trial NCT06536543: EIT Assessment of Overdistension in ARDS Patients in Prone Position
Official title: Pulmonary Overdistension Assessment with Electrical Impedance Tomography in Patients with Acute Respiratory Distress Syndrom in Prone Position
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Respiratory Distress Syndrome
Keywords: Ventilation Induced Lung Injury
lung overdistension
lung collapse
Electrical Impedance Tomography
Pressure Volume curve
Prone Position
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2024-08-05
Enrollment: 20
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: Patients hospitalised in the thoracic intensive care unit, with moderate or severe ARDS according to the Berlin criteria, requiring a prone position, treated with PP equipped with EIT, will be included.

Brief summary: Mechanical ventilation in ARDS requires protective ventilation with low VT and PEEP. PEEP titration can improve lung recruitment in the dependent lung but with a risk of overdistension in the non-dependant lung. EIT can measure the distribution of tidal ventilation and assess overdistension and collapse during a PEEP titration in any position (prone or not).

This study aims to measure the best PEEP as a compromise between recruitment and overdistension during a PEEP trial with EIT before and just after PP.


Eligibility criteria: Inclusion Criteria:

* Patients hospitalized in the ICU and who suffered moderate or severe ARDS (Berlin criteria, PaO2/FiO2\<150), intubated sedated, under myorelaxant and equipped with EIT
* Over the age of 18.

Exclusion Criteria:

* Broncho-pleural leaks
* Pregnant or breastfeeding woman.
* Guardianship or curatorship
* Deprived of liberty
* No health insurance
* Impossibility to correctly position the EIT belt (e.g., dressings, chest drainage, etc.)
* Contra indications to EIT (e.g., implantable cardiac defibrillator, pacemaker, instable spinal lesions)

Primary outcomes:
measure: Level of distension
timeFrame: 48 hours after inclusion day
Secondary outcomes:
measure: Comparison of the % of overdistension and collapse during the EIT-PEEP titration
timeFrame: 48 hours after inclusion day
measure: Repartition of regional ventilation in each part of the lungs.
timeFrame: 48 hours after inclusion day
measure: Assessment of prone position
timeFrame: 48 hours after inclusion day
Other outcomes:
Locations:
city: Pessac
country: France
facility: Hopital Haut-Lévêque
Study officials:
References:
Clinical trial NCT06835543: Soft Tissue Healing After Tooth Extraction
Official title: Assessment of Amnion Membrane Versus Chorion Membrane for Soft Tissue Healing After Tooth Extraction; a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Badly Broken Maxillary Premolars Indicated for Extraction
Badly Broken Down Vital Teeth
Keywords: Amnion membrane
chorion membrane
soft tissue healing
tooth extraction
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2025-02-19
Enrollment: 190
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Statement of the problem: Tooth extraction results in hard and soft tissue loss which complicates prosthodontic rehabilitation, So different techniques of alveolar ridge preservation should be done to maintain hard and soft tissue dimensions.

Aim: The aim of this study is to compare the effect of amnion membrane versus chorion membrane on soft tissue healing among socket preservation procedure.

Detailed description: Aim: The aim of this study is to compare the effect of amnion membrane versus chorion membrane on soft tissue healing among socket preservation procedure.

Materials and Methods: This parallel arm, randomized controlled clinical trial will involve systemically free patients with remaining roots or badly decayed teeth in the posterior region not indicated for immediate implant placement. They will be randomly allocated to two equal groups. Group A (n=95) socket will be grafted with HAM particulate and the socket will be covered with amnion membrane, and group B (n=95) socket will be grafted with HAM particulate and the socket will be covered with chorion membrane. Soft tissue healing will be assessed (1ry outcome) every day for the first week, day after day second week, once in third and fourth week. Postoperative pain and swelling will be recorded daily by the patient for the 1st two weeks post surgically. Postoperative medication will be prescribed to the patient and postoperative instructions will be explained in detail. Follow-up will be performed to assess the parameters and to ensure performing proper oral hygiene. Data collected will be tabulated and statistically analyzed.

Eligibility criteria: Inclusion Criteria:

1. Patients who need simple extraction not indicated for immediate implant placement.

Exclusion Criteria:

1. Patients with inability or anticipated failure to maintain adequate oral hygiene.
2. Pregnant or breast-feeding mothers.
3. Any medical condition or therapy that can affect healing.

Primary outcomes:
measure: Soft tissue healing
timeFrame: every day for the first week, day after day second week, once in third and fourth week
Secondary outcomes:
measure: Healing index
timeFrame: every day for the first week, day after day second week, once in third and fourth week
Other outcomes:
Locations:
city: Suez
country: Egypt
facility: faculty of oral and dental medicine , Suez university
Study officials:
References:
Clinical trial NCT02852343: One-step Nucleic Acid Amplification for Detecting Lymph Node Metastasis of Head and Neck Squamous Cell Carcinoma
Official title: Etude de Concordance Entre la Technique OSNA et Les Techniques Classiques Pour la Recherche de métastases Ganglionnaires Des Cancers Des VADS
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: cN0 Oral Squamous Cell Carcinomas
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2016-08-02
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient with sceduled procedure to cN0 oral squamous cell carcinomas

Brief summary: The investigators main objective is to show that OSNA technique is as accurate as pathological analysis (frozen section / HE staining and immunochemistry) to detect occult lymph node metastasis (micro and macrometastasis).


Eligibility criteria: Inclusion Criteria:

* Patient \> 18 years old
* Head and neck squamous cell carcinoma diagnosed by biopsy
* N0 classification (N0: no lymph node invasion on clinical and radiological examination).
* Neck dissection or sentinel lymph node biopsy required to treat the patient
* ECOG 1,2 or 3
* Patient's consent

Exclusion Criteria:

* Patient previously treated by radiotherapy or surgery for head and neck neoplasm.
* Contraindication or patient unwillingness to undergo surgical treatment
* Incapacitated adults

Primary outcomes:
measure: number of CK19 mRNA copies/µL of diluted lymph node lysate
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Rennes
country: France
facility: Centre hospitalier universitaire de Rennes
Study officials:
References:
citation: Peigne L, Godey F, Le Gallo M, Le Gall F, Fautrel A, Morcet J, Jegoux F. One-step nucleic acid amplification for detecting lymph node metastasis of head and neck squamous cell carcinoma. Oral Oncol. 2020 Mar;102:104553. doi: 10.1016/j.oraloncology.2019.104553. Epub 2020 Jan 28.
Clinical trial NCT01834443: Therapeutic Effects of Galvanic Vestibular Stimulation (GVS) on Spatial Neglect
Official title: Therapeutic Effects of Galvanic Vestibular Stimulation (GVS) on Spatial Neglect
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Spatial Neglect After Right Brain-damage
Keywords: spatial neglect
galvanic vestibular stimulation as therapy
Lead sponsor: Schoen Clinic Bad Aibling
Sponsor class: OTHER
Collaborators: name: German Center for Vertigo and Balance Disorders
First posted: 2013-04-17
Enrollment: 45
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 determine whether galvanic vestibular stimulation is effective in the treatment of spatial neglect after right brain-damage.


Eligibility criteria: Inclusion Criteria:

* spatial neglect after unilateral ischemic infarction or unilateral haemorrhage

Exclusion Criteria:

* Chronic epilepsy
* Metallic implants (including pacemakers)
* Brain tumors
* Scalp inflammation
* Degenerative disease

Primary outcomes:
measure: Change in Neglect Test (NET)due to intervention, the German version of the Behavioral Inattention Test (BIT)
timeFrame: Baseline, Post (day after last intervention session), Follow-up 1 (2 weeks after post testing), Follow-up 2 (4 after post testing)
Secondary outcomes:
measure: Change in visual-tactile search task due to intervention
timeFrame: Baseline, Post (day after last intervention session), Follow-up 1 (2 weeks after post testing), Follow-up 2 (4 after post testing)
measure: Change in subjective haptic vertical due to intervention
timeFrame: Baseline, Post (day after last intervention session), Follow-up 1 (2 weeks after post testing), Follow-up 2 (4 after post testing)
Other outcomes:
measure: Change in subjective visual vertical due to intervention
timeFrame: Baseline, Post (day after last intervention session), Follow-up 1 (2 weeks after post testing), Follow-up 2 (4 after post testing)
Locations:
city: Bad Aibling
country: Germany
facility: Schoen Clinic Bad Aibling
state: Bavaria
Study officials:
References:
Clinical trial NCT05337943: Cognitive Behavioral Therapy and Light Therapy
Official title: Feasibility of Cognitive Behavioral Therapy vs. Bright Light Therapy to Treat Insomnia and Fatigue: an RCT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Hypertension
Insomnia
Fatigue
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2022-04-20
Enrollment: 6
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: Cognitive behavioral therapy (CBT-I) is a common treatment for insomnia that does not use medications. While CBT-I is effective for insomnia, it does not tend to improve the waking symptom of fatigue. Another treatment, Bright Light Therapy, is used for treating seasonal depression and sleep disorders, and may improve fatigue and physical activity in individuals with PAH. The purpose of this study to assess the effects of Bright Light Therapy compared to CBT-I to treat insomnia and fatigue in patients with PAH.

Detailed description: In a single site, 3-arm (Cognitive Behavioral Therapy \[CBT-I\] group; Bright Light Therapy group; Standard of Care group), parallel, randomized controlled trial we will enroll 36 subjects (n=12 per group) to assess the feasibility of Bright Light Therapy compared to CBT-I in subjects with pulmonary arterial hypertension (PAH) to treat insomnia (difficulty initiating sleep or maintaining sleep) and fatigue.

* To assess the recruitment and retention rates of CBT-I and Bright Light Therapy.
* To compare the effects of CBT-I and Bright Light Therapy to Standard of Care on (insomnia and fatigue severity) and secondary (wake after sleep onset and sleep onset latency) outcomes.
* To test the effects of CBT-I and Bright Light Therapy to Standard of Care on the secondary outcome physical activity.
* To test the effects of CBT-I and Bright Light Therapy to Standard of Care on the secondary outcomes: depression, dyspnea and QOL.

Eligibility criteria: Inclusion Criteria:

* PAH diagnosis
* Insomnia
* Fatigue

Exclusion Criteria:

* Untreated obstructive sleep apnea
* Subjects with left-sided valvular disease
* Hospitalized or acutely ill
* Any eye disease such as, but not limited to, cataracts, glaucoma, retinal disorders (e.g. macular degeneration), or previous eye surgery
* Subjects with photosensitivity (e.g. epilepsy)
* Manic-depressive psychosis or Bipolar Disorder

Primary outcomes:
measure: Retention Rate
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Lea Ann A Matura, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05792943: UGT1A1 Genotyping in Taiwanese Cancer Patients
Official title: Impact of Routine UGT1A1 Genotyping Before Irinotecan Chemotherapy in Taiwanese Cancer Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: The Influence of the UGT1A1 Genotype
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2023-03-31
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population of this project is patients with colorectal or pancreatic cancer from the National Taiwan University Cancer Center. A total of 100 cases are expected to be enrolled, ranging in age from 20 to 90 years old.

Brief summary: Irinotecan is commonly used to treat lung, colorectal, pancreatic, stomach, esophageal, and other types of cancer. The main metabolic pathway of SN-38, the active product of Irinotecan, is grape glycoalkaloid acidification by UDP - glucuronosyltransferase (UGT1A1) and then excreted through bile and urine. Clinically, Irinotecan treatment can cause many adverse reactions, and differences in UGT1A1 genotypes can lead to structural changes or functional defects in enzymes, causing reduced acidification of grape glycolaldehyde, and increasing Irinotecan side effects. Therefore, if the patient's ability to metabolize the drug can be assessed before taking the drug, it will be of great help in treatment.

Until 2021, cancer will remain the top ten causes of death in Taiwan, of which colorectal and pancreatic cancer rank third and seventh among the top ten cancers in Taiwan, respectively, and these two cancers often use complex chemotherapy including irinotecan. Routine detection of UGT1A1 genotype in patients with colorectal and pancreatic cancer before irinotecan treatment predicts the drug metabolism capacity of irinotecan and adjusts the dose, allowing patients receiving irinotecan to reduce the harm of side effects. At present, the UGT1A1 genotype evaluated is usually only UGT1A1\*28, but the common UGT1A1 genotype in Taiwan also has UGT1A1\*6 and UG1A1\*63, etc. There is no literature on Taiwanese cancer patients with actual irinotecan chemotherapy, so this study aims to explore the influence of the UGT1A1 genotype and develop other UGT1A1 genotype test methods. It is expected that molecular testing tools can improve cancer precision medicine and provide personalized medicine.


Eligibility criteria: Inclusion Criteria:

Colorectal or pancreatic cancer patients.

Exclusion Criteria:

Age less than 20 or greater than 90.

Primary outcomes:
measure: Using Sanger sequencing and real-time polymerase chain reaction analysis to study the distribution of UGT1A1 gene in cancer patients in Taiwan.
timeFrame: One month after receiving the samples.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01579643: OCT-guided LALAK in Children
Official title: Randomized Clinical Trial of OCT-guided Laser-assisted Lamellar Anterior Keratoplasty in Children
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Corneal Opacity
Keywords: cornea
opacity
congenital
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Eye Institute (NEI)
First posted: 2012-04-18
Enrollment: 1
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary goal of the trial is to determine if laser-assisted lamellar anterior keratoplasty (LALAK) will reduce the risks of post-operative complications such as adhesions, glaucoma and cataract that are associated with pediatric penetrating keratoplasty (PK).

Detailed description: There is a great need for lamellar keratectomy in the treatment of congenital opacities because the rejection rate in pediatric PK is 4-5 times higher than in adults. In addition, the intraocular inflammatory reaction in infants often leads to synechiae, glaucoma, and cataract. Because LALAK does not penetrate the eye and preserves the host endothelium, it could reduce the risk of these complications. Keratoplasty must be performed at this early age to prevent amblyopia.

In this study, OCT-guided LALAK will be performed in patients whose vision is limited by opacity in the anterior 2/3 of the cornea. The objective is to determine if LALAK will provide an equal or better visual outcome than traditional PK without the associated post-operative complications.

Eligibility criteria: Inclusion Criteria:

* Vision limited by opacity in the anterior 2/3 of the corneal stroma
* Posterior opacity and endothelial defect must be less than 1 mm in diameter

Exclusion Criteria:

* Presence of cataract
* Presence of adhesions of the iris or lens to the cornea
* Inability/unwillingness of parents to give informed consent
* Inability of parents to commit to required visits to complete the study

Primary outcomes:
measure: Number of LALAK patients with post operative complications compared to PK patients
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Children's Hospital of Los Angeles
state: California
Study officials:
affiliation: Children's Hospital Los Angeles
name: Bibiana Reiser, MD
role: PRINCIPAL_INVESTIGATOR
References: