louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02509234: Trabectedin and Irinotecan for Refractory Pediatric Sarcomas
Official title: Trabectedin and Irinotecan in Pediatric Refractory Sarcomas
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Recurrent Childhood Soft Tissue Sarcoma
Recurrent Ewing Sarcoma
Recurrent Rhabdomyosarcoma
Keywords: pediatric sarcomas
Ewing sarcoma
rhabdomyosarcoma
soft tissue sarcoma
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
First posted: 2015-07-27
Enrollment: 30
Sex: ALL
Minimum age (years): 10
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adolescents and young adults (age10 - 40 yoa) with refractory sarcoma

Brief summary: The purpose of the study is to evaluate patients with refractory childhood sarcomas, who have been treated with a combination therapy of trabectedin and irinotecan (within compassionate use), to determine, if this is a promising treatment option with acceptable toxicity and if the results warrant a prospective study.


Eligibility criteria: Inclusion Criteria:

* Adolescents and young adults (age10 - 40 yoa) with refractory sarcoma, for which there are presently no further treatment options in EURO-Ewing/ EURAMOS/CWS (i.e. ≥ second relapse in ES, resistance to surgery in osteosarcoma, relapsed rhabdomyosarcoma) and have been treated with a combined chemotherapy of trabectedin and irinotecan (described in intervention)
* existing matched control in existing study databases
* have started of treatment within three months of last progress

Key Exclusion Criteria:

* Patients newly diagnosed or in first relapse.

Primary outcomes:
measure: Toxicity during therapy
timeFrame: As long as patient is undergoing therapy/ 6 months
Secondary outcomes:
measure: Quality of life
timeFrame: 12 months
measure: Assessment of therapeutic effect
timeFrame: 12 months
measure: Assessment of time to treatment failure
timeFrame: 12 months
Other outcomes:
measure: Overall survival in comparison to matched controls.
timeFrame: 12 months
measure: Differences in response rate comparing response rate in Ewing Sarcoma to response rate in Soft Tissue Sarcoma
timeFrame: 12 months
measure: Event free survival in comparison to matched controls.
timeFrame: 12 months
Locations:
Study officials:
affiliation: Kinderklinik München Schwabing - Klinik und Poliklinik für Kinder- und Jugendmedizin, Klinikum Schwabing, Städtisches Klinikum München GmbH und Klinikum Rechts der Isar (AöR) der Technischen Universität München
name: Stefan Burdach, Prof.
role: STUDY_CHAIR
References:
Clinical trial NCT06510634: Triage of Patients Presenting Beyond 24 Hours With Ischemic Stroke Due to Vertebrobasilar Artery Occlusion
Official title: Effectiveness and Safety of Endovascular Treatment vs. Best Medical Treatment in Patients With Vertebrobasilar Artery Occlusion Presenting Beyond 24 Hours of Last Known Well：a Prospective, Multicenter Registry Study
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Stroke, Ischemic
Lead sponsor: Tianjin Huanhu Hospital
Sponsor class: OTHER
First posted: 2024-07-19
Enrollment: 236
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study is a prospective, multicenter cohort study, which analyzed the prospectively databases of 11 stroke centers.Including patients with ischemic stroke due to vertebrobasilar artery beyond 24 hours from last known well.

Brief summary: Endovascular thrombectomy (EVT) for posterior circulation occlusion is generally performed within a window of less than 24 hours from the time the patient was last known well (LKW). The efficacy and safety of EVT beyond the 24-hour window remain uncertain.


Eligibility criteria: Inclusion Criteria:

1. age≥18 years.;
2. blockage in the vertebrobasilar artery, including the vertebral artery or basilar artery, determined using computed tomographic angiography (CTA)/ magnetic resonance angiography (MRA)/digital subtraction angiography (DSA);
3. VBAO occurrence more than 24 hours from LKW;
4. none to mild premorbid disability defined by modified Rankin Scale (mRS) score ≤2;
5. informed consent before enrollment in the clinical trials.

Exclusion Criteria:

1. neuroimaging evidence of cerebral hemorrhage on presentation;
2. lack of follow up information on outcomes at 90 days
3. serious, advanced, or terminal illness.

Primary outcomes:
measure: proportion of patients with Modified ranking scale (mRS) (0-3) at 90 days
timeFrame: 90(±14)days
Secondary outcomes:
measure: distribution of patients with Modified ranking scale (mRS) (0-3) at 90 days
timeFrame: 90(±14)days
measure: Mortality within 90 days
timeFrame: 90(±14)days
measure: Incidence of symptomatic intracranial haemorrhage
timeFrame: 90(±14)days
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Huanhu Hospital
state: Tianjin
Study officials:
References:
Clinical trial NCT04044534: Intranasal Insulin for Posttraumatic Stress Disorder
Official title: Intranasal Insulin for Treating Posttraumatic Stress Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: PTSD
Keywords: Intranasal insulin
PTSD
Lead sponsor: VA Connecticut Healthcare System
Sponsor class: FED
First posted: 2019-08-05
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To evaluate if intranasal insulin is effective in reducing PTSD symptoms.

Detailed description: The current proposal aims to study the pharmacotherapeutic effects of intranasal insulin on PTSD symptoms and inhibition of amygdala hyperactivation in subjects with PTSD.

Eligibility criteria: Inclusion Criteria:

* Male or female, 21-65 years old
* Current PTSD
* Able to provide written informed consent

Exclusion Criteria:

* Unstable medical condition, clinically determined by a physician
* Diabetes requiring insulin or oral hypoglycemic agents
* Moderate-severe traumatic brain injury
* Current psychotic disorder, bipolar disorder, cognitive disorder in the past 12 months
* Current substance use disorders (except alcohol, tobacco, or cannabis) in the past 3 months
* Changes in doses of psychotropic medications in the past 4 weeks
* Initiation of individual therapy or counseling in the past 4 weeks
* Imminent suicidal or homicidal risk
* Contraindication to Insulin
* History of claustrophobia
* Presence of cardiac pacemaker or other electronic device or ferromagnetic metal foreign bodies in vulnerable positions as assessed by a standard pre-MRI safety screening questionnaire

Primary outcomes:
measure: Post-traumatic stress disorder (PTSD) symptoms as measured by the Clinician Administered PTSD Scale for DSM-5 (CAPS-5)
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: West Haven
country: United States
facility: VA Connecticut Healthcare System
state: Connecticut
Study officials:
affiliation: VA Connecticut Healthcare System
name: Gihyun Yoon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01527734: Comparison Study of Liquid and Lyophilized Formulations of Subcutaneous Tetrodotoxin (TTX) in Healthy Volunteers
Official title: COMPARISON OF THE PHARMACOKINETICS AND SAFETY OF LIQUID (30 µg) AND LYOPHILIZED TETRODOTOXIN (15 µg AND 30 µg) FOLLOWING SINGLE AND TWICE DAILY SUBCUTANEOUS DOSE ADMINISTRATION TO HEALTHY VOLUNTEERS-DETERMINATIONS IN BLOOD AND URINE
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Comparison study
Lead sponsor: Wex Pharmaceuticals Inc.
Sponsor class: INDUSTRY
First posted: 2012-02-07
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SCREENING

Brief summary: The study design is a randomized, double-blind, placebo-controlled, parallel-group, dose comparison with a open-label, crossover, formulation comparison.


Eligibility criteria: Inclusion Criteria:

* Normal renal function

Exclusion Criteria:

* History of multiple clinically significant drug allergies

Primary outcomes:
measure: Compare plasma and urine PK profiles of TTX following doses of Lyophilized and Injectable Liquid TTX
timeFrame: 26 timepoints over 48 hours
Secondary outcomes:
measure: Assess the safety and tolerability of TTX following the administration of Lyophilized and Liquid TTX
timeFrame: signage of the ICF to Day 10
Other outcomes:
Locations:
city: Tacoma
country: United States
facility: Comprehensive Clinical Research
state: Washington
Study officials:
References:
Clinical trial NCT02812134: Impact of Oral Phosphorus Supplements on the 6-month Change in FGF23 Levels in Anorexic Adolescents Suffering From Undernutrition.
Official title: Impact of Oral Phosphorus Supplements on the 6-month Change in FGF23 Levels in Anorexic Adolescents Suffering From Undernutrition.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Malnutrition
Keywords: phosphorus supplementation
FGF23
anorexic
adolescents
undernutrition
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2016-06-24
Enrollment: 30
Sex: ALL
Minimum age (years): 11
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: anorexic patients

Brief summary: Fibroblast growth factor 23 (FGF23) is a recently discovered phosphaturic hormone produced by osteocytes. It is involved in phosphate-calcium metabolism (via its phosphaturic action and inhibition of 1,25-OH vitamin D).

There are no published studies on the role of FGF23 in undernourished anorexic adolescents taking oral phosphorus supplements.


Eligibility criteria: Inclusion Criteria:

* Adolescents aged from 11 to 17
* Follow-up or hospitalisation for anorexia
* Overt undernutrition (clinical signs of undernutrition, body mass index and the Waterlow index)
* Social security coverage

Exclusion Criteria:

* Known pre-existing renal disorders
* Known constitutional disorders of phosphate-calcium metabolism
* Adult patients, legal guardianship, incarceration

Primary outcomes:
measure: FGF23
timeFrame: at inclusion and then once a month for 6 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
affiliation: CHU Amiens
name: Lydia LICHTENBERGER, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05599334: A Retrospective Observational Study of Patients With Early-stage HER2-positive Breast Cancer, Treated With Neratinib
Official title: A Retrospective Observational Study of Adult Patients With Early-stage HER2-positive Breast Cancer, Treated With Neratinib as Extended Adjuvant Therapy in the Context of the European Early Access Program (NEAR)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Adjuvant Therapy
HER2-positive Breast Cancer
Keywords: HER2-positive Breast Cancer
Adjuvant therapy
Lead sponsor: Pierre Fabre Medicament
Sponsor class: INDUSTRY
Collaborators: name: Iqvia Pty Ltd
First posted: 2022-10-31
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will include all patients with early-stage HER2+ breast cancer having received at least one dose of neratinib as an extended adjuvant therapy in the context of the EAP in Europe between August 01, 2017 and December 31, 2020.

Brief summary: The purpose of this study is to describe the demographic and clinical profiles of patients with early-stage HER2+ breast cancer treated with neratinib as an extended adjuvant therapy as part of the Early Access Program (EAP) in Europe.


Eligibility criteria: Inclusion Criteria:

* Patients will be eligible for inclusion if they fulfill all of the following criteria:

  * Age ≥ 18 years at neratinib treatment initiation
  * Having received at least one initial dose of neratinib as an extended adjuvant therapy for the treatment of early-stage HER2+ breast cancer, in the context of the EAP in Europe, and between August 01, 2017 and December 31, 2020
  * Patients (or next of kin/legal representative, if applicable) who provide written informed consent or non-opposition.

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Description of age
timeFrame: At baseline
measure: Description of Gender
timeFrame: At baseline
measure: Description of BMI
timeFrame: At baseline
measure: Menopausal status
timeFrame: At baseline
measure: Comorbidities
timeFrame: At baseline
measure: HER2 overexpression/amplification testing
timeFrame: At initial diagnosis
measure: Hormone receptor status
timeFrame: At initial diagnosis
measure: Primary tumor location
timeFrame: At initial diagnosis
measure: Primary tumor histology
timeFrame: At initial diagnosis
measure: Histological grade
timeFrame: At initial diagnosis
measure: Pathologic stage (AJCC classification) of Breast Cancer
timeFrame: At initial diagnosis
Secondary outcomes:
Other outcomes:
Locations:
city: Bouge
country: Belgium
facility: Clinique Saint-Luc Bouge
Study officials:
References:
Clinical trial NCT00213434: Evaluation of a Mandibular Advancement Device in the Treatment of Obstructive Sleep Apnea Syndrome
Official title: Prospective Evaluation of Mandibular Advancement by Herbst Device in the Treatment of Moderate Obstructive Sleep Apnea Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Keywords: prospective
randomized
polysomnography
orthodontic appliance, removable
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2005-09-21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if the mandibular advancement by Herbst device is effective in the treatment of moderate obstructive sleep apnea patients.


Eligibility criteria: Inclusion Criteria:

* Moderate sleep apnea syndrome (10 \< Respiratory Disorder Index \< 30)
* Body mass index (BMI) \< 35 Kg/m2
* Able to give their informed consent

Exclusion Criteria:

* Pregnant women
* Professional drivers requiring continuous positive airway pressure (CPAP) treatment
* Psychiatric disorders, and patients unable to realise to study
* Severe respiratory pathology which could interfere with the study
* Morpheic epilepsy
* Benzodiazepines intake
* Chronic nasal obstruction
* Ear, nose, and throat (ENT) pathology requiring surgery
* Previous uvulopalatoplasty surgery
* Temporomandibular joint pathology
* Gum disease
* Insufficient number of teeth to apply the oral appliance
* Mobile teeth

Primary outcomes:
measure: Comparison of polysomnographic data after 3 months of treatment by oral appliance in 2 groups: one with Herbst device adjusted in maximal mandibular advancement and a placebo group
Secondary outcomes:
measure: Efficacy on clinical symptoms
measure: Tolerance of the oral appliance
measure: Identification of predictive factors of efficacy
measure: Feasibility of this therapeutic method
Other outcomes:
Locations:
city: Rouen
country: France
facility: CHU de ROUEN
Study officials:
affiliation: University Hospital, Rouen
name: PORTIER PF Florence, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00845234: Establishing a Standard for Peri-operative Implantable Cardioverter Defibrillator (ICD) Patient Education
Official title: Establishing a Standard for Peri-operative ICD Patient Education: A Demonstration Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arrhythmia
Keywords: behavioral intervention
implantable cardioverter defibrillator
psychosocial education
anxiety
depression
Lead sponsor: East Carolina University
Sponsor class: OTHER
Collaborators: name: Aurora Denver Cardiology Associates
name: Medtronic
First posted: 2009-02-18
Enrollment: 62
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: An implantable cardioverter defibrillator (ICD) administers a shock to terminate potentially life-threatening cardiac arrhythmias. The device saves lives, but presents psychological challenges for patients. At present, there is a paucity of brief interventions for ICD patients designed for administration in a clinic setting that considers issues of cost, time, and available resources. The present study examined the impact of a brief cognitive behavioral (CBT) educational intervention on primary endpoints of patient acceptance and quality of life and secondary endpoints of depression and anxiety. It was hypothesized that the intervention would result in significant improvements primary and secondary endpoints for participants in the intervention group.


Eligibility criteria: Inclusion Criteria:

* 18+ years old
* literate
* newly implanted with an implantable cardioverter defibrillator (ICD)

Exclusion Criteria:

* documented neurological sequelae associated with CVA or dementia
* documented cognitive impairment
* reported illiteracy
* previously implanted ICD

Primary outcomes:
measure: Score on measure assessing construct of quality of life
timeFrame: Up to 8 months after enrollment
Secondary outcomes:
measure: Score on measure assessing depression
timeFrame: Up to 8 months after enrollment
measure: score on measure assessing construct of patient acceptance of device
timeFrame: up to 8 months after enrollment
measure: score on measure assessing anxiety
timeFrame: Up to 8 months after enrollment
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Aurora Denver Cardiology Associates
state: Colorado
city: Lone Tree
country: United States
facility: Aurora Denver Cardiology Associates
state: Colorado
city: Greenville
country: United States
facility: East Carolina Heart Institute
state: North Carolina
Study officials:
affiliation: East Carolina University
name: Samuel F Sears, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00407134: Acute Haemodynamic Effects of Peritoneal Dialysis as Evaluated by Sphygmocor Technology
Official title: Acute Haemodynamic Effects of Peritoneal Dialysis as Evaluated by Sphygmocor Technology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peritoneal Dialysis
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2006-12-04
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Subjects with peritoneal dialysis are randomized to different groups. The different groups receive different intra-abdominal volumes and different glucose-concentrations.

The effects on blood pressure and other cardiovascular parameters (e.g. central blood pressure, augmentation index, ...) will be evaluated.


Eligibility criteria: Inclusion Criteria:

* Subjects with peritoneal dialysis
* Aged 18-80 years

Primary outcomes:
measure: Blood pressure
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Wim Van Biesen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02484534: Thrombin Generation Test in Patient With Liver Cirrhosis
Official title: Thrombin Generation Test in Patient With Liver Cirrhosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cirrhosis
Keywords: Coagulation Factor
cirrhosis
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2015-06-29
Enrollment: 36
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 (men and women) who are hospitalized in internal and surgical wards with a diagnosis of cirrhosis of the liver.

Brief summary: Cirrhotic patients are patients with high morbidity and mortality, it is very important for determining the prognosis of these patients. The importance increases when these patients waiting for a liver transplant. The Model for End-Stage Liver Disease (MELD) is a reliable measure of mortality risk in patients with end-stage liver disease. It is used as a disease severity index to help prioritize allocation of organs for transplant. MELD uses the patient values for serum bilirubin, serum creatinine, and the international normalized ratio for prothrombin time (INR) to predict survival.

Blood tests that we use today in daily practice to evaluate the coagulation system (PT, PTT) do not check actually the functioning of the system, but examine the level of clotting factors and therefore only verify that the side of Anticoagulant of the equation and not the side of the procoagulant .

To examine the coagulation system function tests have been developed, One of them is the thrombin generation. The purpose of the trial is to determine whether thrombin generation test can be a prognostic indicator in patients cirrhosis.


Eligibility criteria: Inclusion Criteria:

Cirrhosis patient MELD ( Model For End-Stage Liver Disease) above 12

Exclusion Criteria:

Pregnant women

Primary outcomes:
measure: Complications of cirrhosis.
timeFrame: 3 month.
Secondary outcomes:
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Haemek medical center
Study officials:
References: