louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00604227: Pulmonary Function at High-Altitude
Official title: Interstitial Pulmonary Edema After Rapid Ascent to High Altitude (Margherita Hut, 4559 m)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Edema
Keywords: high altitude pulmonary edema
pulmonary interstitial fluid
pulmonary function testing
hypoxia
pulmonary endothelial function
high altitude exposure without prior acclimatization
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2008-01-30
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: Based on the findings of decreased vital capacity, decreased FEV1 and increased closing volume after ascent to high altitude, some investigators suggest the presence of a subclinical high altitude pulmonary edema (HAPE). Since these parameters are only indirect measures of pulmonary interstitial fluid accumulation, the aim of this study is to examine the effects of broncho-constriction on the increase of closing volume by extensive lung function testing in healthy mountaineers at low altitude and on the Margherita Hut (4559 m). As has been done in earlier studies, conventional thorax radiographs are used for verification of HAPE. In this study, the determination of the thoracic fluid quantity will be completed by measurements of thoracic impedance. In addition markers of pulmonary endothelial function will be assessed to get further insight into the regulation of pulmonary vascular tone at altitude and in particular into the pathophysiology of HAPE.


Eligibility criteria: Inclusion Criteria:

* Mountaineering ability required for reaching the Margherita hut (4559 m)

Exclusion Criteria:

* Borne above 1500 m
* Subjects with internal medical diseases like all cardiac diseases, all pulmonary diseases, Diabetes mellitus, infectious diseases, thyroid diseases, malignant diseases, hepatic or renal diseases,
* (Known) hypersensitivity to salbutamol or to another component of sultanol® or lidocaine, or to another component of xylocain® pump spray
* Intake of drugs, especially nifedipine, acetazolamide and glucocorticoids or of drugs interacting with sultanol® or xylocain® pump spray
* Pregnancy

Primary outcomes:
measure: development of HAPE
timeFrame: during the 48 h stay at altitude
Secondary outcomes:
measure: change of lung function parameters from low to high altitude
timeFrame: during the 48 h stay at altitude
measure: markers of pulmonary endothelial function
timeFrame: during the 48 h stay at altitude
measure: quantification of pulmonary interstitial fluid
timeFrame: during the 48 h stay at altitude
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Sports Medicine, University Hospital
Study officials:
affiliation: University Hospital Heidelberg
name: Christoph Dehnert, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Heidelberg
name: Marc M Berger, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Heidelberg
name: Peter Bärtsch, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03403127: PET CT Re-Planning NSCLC (4DCT-PET)
Official title: Prospective Study of CT and PET Imaging During a Course of Radical Radiotherapy to Determine the Dosimetric Benefits of Re-Planning in Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Non-Small Cell Lung Cancer
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2018-01-18
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study will see whether the addition of more frequent planning CTs during the course of radiation, and of Positron Emission Tomography (PET), a diagnostic test similar to CT, prior to and during a course of radiation may provide information that could potentially be used during the treatment to improve the initial radiation plan.


Eligibility criteria: Inclusion Criteria:

* Age equal to or more than 18 years old
* Patients with NSCLC consenting for radiotherapy to the primary tumor and / or mediastinal / hilar lymph nodes. Prescription doses should be 60Gy or higher.
* Chemo-RT patients of any stage of NSCLC
* Patients with a measurable tumor on CT scan.
* Patients who are able to lie supine for two consecutive 25 minutes sessions.

Exclusion Criteria:

* Trimodality patients who will have surgery within 2 months post RT
* Previous radiotherapy to intended treatment volumes.
* Patients with recurrent disease
* Active malignancy other than lung cancer
* Pregnancy
* Failure to provide written informed consent

Primary outcomes:
measure: GTV volumes
timeFrame: 2 weeks post RT treatment
measure: GTV volumes
timeFrame: 4 weeks post RT Treatment
measure: GTV volumes
timeFrame: 7 weeks post RT Treatment
measure: GTV volumes
timeFrame: 3 months post RT treatment
measure: GTV volumes
timeFrame: 2 weeks post RT Treatment
measure: GTV Volumes
timeFrame: 4 weeks post RT Treatment
measure: GTV Volumes
timeFrame: 7 weeks post RT Treatment
measure: GTV volumes
timeFrame: 3 months post RT treatment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02335827: Irreversible Electroporation(IRE) For Unresectable Renal Tumors
Official title: Irreversible Electroporation (IRE) for Unresectable Renal Tumors: Phase I and Phase II Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Tumor
Keywords: irreversible electroporation
renal tumor
Lead sponsor: Fuda Cancer Hospital, Guangzhou
Sponsor class: OTHER
First posted: 2015-01-12
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
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 investigate the safety and efficacy of irreversible electroporation (IRE) for unresectable renal tumors.

Detailed description: By enrolling patients with renal tumors adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of percutaneous or intraoperative IRE for renal tumors .

Eligibility criteria: Inclusion Criteria:

* unresectable kidney tumors
* patients refused surgical therapy
* Karnofsky-index \>70%
* Age ≥ 18 and ≤ 80 years
* life expectancy ≥ 12 month
* compliance of the patient taking part in a study
* informed consent

Exclusion Criteria:

* violation against one or more inclusion criteria
* an estimated glomerular filtration rate (eGFR) of \< 30 mL/min/1.73 m2
* QT-interval \>550 ms or cardiac arrhythmias or condition after myocardial infarction, that make an ECG-synchronisation unfeasible
* active infection or severe health interference, that make taking part in a study unfeasible
* pregnancy, lactation period
* general contraindications for anesthesia, endotracheal anesthesia and muscle relaxation
* psychiatric disorders that make taking part in a study or giving informed consent unfeasible
* haemorrhage, impossible intermission of taking blood thinner, untreatable thrombophilia
* thromboplastin time ≤50 %, thrombocytes ≤50 Gpt/L; partial thromboplastin time \>50
* untreated urinary retention
* severe hepatic dysfunction
* any other clinically important renal, hematological, metabolic, neurological, gastrointestinal, hepatic or pulmonary disorders or dysfunctions preventing study participation (investigator's assessment)
* taking part in another clinical study for renal tumor.

Primary outcomes:
measure: adverse effects
timeFrame: 1 month
measure: Quality of Life (QoL)
timeFrame: 2 months
measure: procedural compliance
timeFrame: 3 months
Secondary outcomes:
measure: Recurrence rate
timeFrame: 12 months
measure: Voltage (A minimum and maximum range of voltage for safe and effective IRE)
timeFrame: 3 months
Other outcomes:
measure: Progress free disease (PFS)
timeFrame: 12 months
measure: Overall survival (OS)
timeFrame: 36 months
Locations:
city: Guangzhou
country: China
facility: Fuda Cancer Hospital
state: Guangdong
Study officials:
affiliation: Fuda Cancer Hospital
name: Lizhi Niu, PHD
role: STUDY_CHAIR
References:
Clinical trial NCT04242927: A Study to Investigate Nicotinic Acid on VEGFR Inhibitor-Associated Hand-Foot Skin Reactions
Official title: Efficacy of Nicotinic Acid for VEGFR Inhibitor-Associated Hand-Foot Skin Reactions in Solid Tumor Patients: a Randomised Controlled Phase 2 Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Hand-Foot Skin Reaction (HFSR)
Lead sponsor: First People's Hospital of Hangzhou
Sponsor class: OTHER
Collaborators: name: Zhejiang University
First posted: 2020-01-27
Enrollment: 36
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: SUPPORTIVE_CARE

Brief summary: Hand-Foot Skin Reaction (HFSR) is a common adverse event induced by Vascular Endothelial Growth Receptor Inhibitor (VEGFRi) in cancer patients. The main purpose of this study is to evaluate the efficacy and safety of nicotinic acid in solid tumor patients with grade II/III VEGFRi-associated HFSR.


Eligibility criteria: Inclusion Criteria:

* Written informed consent obtained prior to performing any protocol-related procedures, including blood serum collecting
* HFSR grade 2 or higher after treatment with VEGFR inhibitors (such as sorafenib, regorafenib, anlotinib, and apatinib), according to NCI CTCAE V5.0 - PPE
* Age from 18 to 75 years.
* Life expectancy of at least 3 months at Day 1

Exclusion Criteria:

* History of allergy to B vitamins
* Major surgery or severe traumatic injury, fracture within 4 weeks prior to first dose of nicotinic acid or ulceration and any factors that significantly affect oral drug absorption, such as inability to swallow, chronic diarrhea, and intestinal obstruction
* Patient who takes isoniazid in combination with sorafenib and other VEGFR inhibitors.
* History of psychiatric drugs substance abuse and fails to quit it or has amental disorder
* Pregnant or nursing women, fertile patient who is unwilling or unable to use effective contraception

Primary outcomes:
measure: Response rate of VEGFR inhibitor-associated hand-foot skin reaction
timeFrame: 2 year
measure: Complete response rate of VEGFR inhibitor-associated hand-foot skin reaction
timeFrame: 2 year
Secondary outcomes:
measure: Dose adjustment/withdrawal ratio
timeFrame: 2 year
measure: Hand-Foot Reaction Quality of Life (HF-QoL)
timeFrame: 2 year
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: First People's Hospital of Hangzhou
state: Zhejiang
Study officials:
affiliation: First People's Hospital of Hangzhou
name: Shenglin Ma, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02867527: Prospective Constitution of Database Gathering Data of Patients Suffering From Glaucoma Followed at University Hospital of Grenoble
Official title: Prospective Constitution of Database Gathering Data of Patients Suffering From Glaucoma Followed at University Hospital of Grenoble
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Glaucoma
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2016-08-16
Enrollment: 400
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: The data from all major subjects with primary or secondary glaucoma and examined for initial management or monitoring in the ophthalmology department of the University Hospital of Grenoble will be included in the database.

Brief summary: Few publications provide information on the natural history of glaucoma, outside of clinical trials do not always reflect what is observed in common situation for various reasons (specific selection criteria and sometimes restrictive, stronger motivations patients and physicians to comply with follow-up visits and prescribed treatments, etc.). Therefore, much information on the natural history of glaucoma are unknown to date (degradation rate of visual field and visual function over time, risk of blindness in the years following diagnosis, effects of various treatments to reduce intraocular pressure and preserving visual field deterioration, etc.). Obtaining such important data to improve the management of glaucoma patients (choice of treatment methods, identification of predictors of rapid change that can make choosing more aggressive treatment and more regular monitoring, etc.) requires the establishment of cohort of patients followed and treated with the methods usually used in current practice, and besides therapeutic trial.


Eligibility criteria: Inclusion Criteria:

* Patients whose age is above 18 years
* Patients with primary or secondary glaucoma or both sides

Exclusion Criteria:

* Major person under guardianship or unable to consent
* Patient Refusal

Primary outcomes:
measure: Degradation rate of visual field and visual function in patients treated with the methods usually used in current practice
timeFrame: 15 years
Secondary outcomes:
Other outcomes:
Locations:
city: Grenoble
country: France
facility: University Hospital Grenoble
Study officials:
References:
Clinical trial NCT03475927: Knowledge and Awareness of Radiation Hazard in Health-care Personnel
Official title: Knowledge and Awareness of Radiation Hazard in Health-care Personnel; A Quaternary-care Academic Center Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Radiation Hazard
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2018-03-23
Enrollment: 214
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: anesthetic personnel and surgeon who contact riadiation equipment

Brief summary: Knowledge and awareness of radiation hazard in health-care personnel; A Quaternary-care academic center study Aim: To determine knowledge and concerning about radiation hazard in anesthetic personnel and surgeon

study decide: questionnaire based study to ask concerning and knowledge about radiation hazard


Eligibility criteria: Inclusion Criteria:

* Anesthetic personnel
* Surgeon: urology, orthopedic, cardiothoracic, neurosurgeon, general

Exclusion Criteria:

* none

Primary outcomes:
measure: score of multiple choice question test about radiation hazard knowledge in anesthetic personnel and surgeon
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: faculty of medicine Siriraj hospital
Study officials:
References:
Clinical trial NCT01588327: A Prospective Pharmacodynamic Study of Dabigatran
Official title: A Prospective Pharmacodynamic Study of Dabigatran Using Peak and Trough Coagulation Test Results in Patients on Therapeutic Doses of Dabigatran
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Blood Coagulation Tests
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2012-04-30
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients taking FDA-approved doses of dabigatran and control subjects not taking an anticoagulant or antiplatelet were eligible for inclusion.

Brief summary: The ability to explain bleeding or clotting complications in patients treated with dabigatran remains challenging. In addition, there is limited data on how coagulation tests perform in patients treated with therapeutic doses of dabigatran. Predicted responses of coagulation tests to therapeutic doses of dabigatran may be helpful in better understanding abnormal responses to dabigatran. The purpose of the study is to define a therapeutic reference range for peak and trough coagulation tests in patients taking FDA approved doses of dabigatran and to determine which tests may be most clinically useful for monitoring dabigatran.


Eligibility criteria: Inclusion Criteria:

• Medication therapy with dabigatran 75 mg twice daily or 150 mg twice daily for a minimum of 3 days

Exclusion Criteria:

* CrCl \< 15 ml/min
* Non-FDA approved dose based on calculated CrCl with most recent SCr
* Age \< 18 years
* Inability to communicate in the English language
* Decisionally-impaired individuals
* Incarcerated
* Pregnant/Lactating (Pregnancy category: C, unevaluated effects in lactation)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Emily Hawes, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hawes EM, Deal AM, Funk-Adcock D, Gosselin R, Jeanneret C, Cook AM, Taylor JM, Whinna HC, Winkler AM, Moll S. Performance of coagulation tests in patients on therapeutic doses of dabigatran: a cross-sectional pharmacodynamic study based on peak and trough plasma levels. J Thromb Haemost. 2013 Aug;11(8):1493-502. doi: 10.1111/jth.12308.
Clinical trial NCT01527227: Parentification Among Children Whose Parents Cope With a Serious Mental Illness
Official title: Parentification Among Children Whose Parents Cope With a Serious Mental Illness
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Mental Illness
Keywords: Children of mentally ill
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2012-02-06
Enrollment: 130
Sex: ALL
Minimum age (years): 9
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The research group will be recruited by the WHO and ICMJE with sampling method. The comparison group will be recruited from schools.

Brief summary: The research will examine effects of personal, familial, societal and intergenerational characteristics on parentification, the effects of parentification on the quality of life of the child and what encourages a better quality of life. This research will include 130 children between the ages of 10-18 who live with at least one parent who struggles with serious mental illness in a comparison to 130 children of the same socio-demographic characteristics raised by parents from a non-clinical population. The differences between these two populations with regard to parentification, quality of life, social support and fairness will also be examined. The parents and the children will fill out questionnaires. The research group will be recruited from rehabilitation services, mental health clinics, psychiatric hospitals and social welfare departments with sampling method. The comparison group will be recruited from schools. This research broadens the knowledge of the causes and the repercussions of parentification among children of parents who struggles with serious mental illness in comparison with children raised by parents from a non-clinical population. Few studies have examined children of the mentally ill in Israel, and there are none which examined parentification.


Eligibility criteria: Inclusion Criteria:

* children who live with at least one parent who struggles with serious mental illness

Exclusion Criteria:

* Arabic children

Primary outcomes:
measure: Filial Responsibility Scale-Youth (child fill out)
timeFrame: 1 year
Secondary outcomes:
measure: The Social Support Appraisals Scale (Dubow & Ullman,1989)(child fill out)
timeFrame: 1 year
measure: "The Alabama Parenting Questionnaire"; Shelton, Frick & Wootton, 1996 (parent fill out)
timeFrame: 1 year
measure: Parental Bonding Instrument (PBI) (parent fill out)
timeFrame: 1 year
measure: Social support and social conflict (parent fill out)
timeFrame: 1 year
Other outcomes:
Locations:
city: All the Country
country: Israel
facility: Rehabilitation Services
Study officials:
References:
Clinical trial NCT01943227: Effect of Alveolar Minute Ventilation on Respiratory Gas Heat Content
Official title: Effect of Alveolar Minute Ventilation on Respiratory Gas Heat Content
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ventilation Perfusion Mismatch
Keywords: humidity
enthalpy
mechanical ventilation
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2013-09-16
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: adult patients without cardiac or respiratory illness

Brief summary: This is a single site, prospective, non-blinded, non-randomized, non-interventional study designed to evaluate the effect of changes in alveolar minute ventilation on the measurement of respiratory heat loss (enthalpy).

Detailed description: This is a single site, prospective, non-blinded, non-randomized, noninterventional study designed to evaluate the effect of changes in alveolar minute ventilation on the measurement of respiratory heat loss (enthalpy). Each patient will serve as their own control. The study will enroll adult patients without cardiac or respiratory illness. It is designed to evaluate the effect of the ventilatory pattern (tidal volume, rate) on respiratory heat loss measured using the VQm™ monitor during standard intra-operative clinical care that requires positive pressure ventilation (PPV)

Eligibility criteria: Inclusion Criteria:

* age greater than 18 years
* scheduled for an elective surgical procedure with an anticipated duration of more than 2 hours requiring general anesthesia and positive pressure ventilation using an endotracheal tube
* patient status ASA 1, 2 or 3
* no significant cardio-vascular or respiratory disease
* supine surgical position

Exclusion Criteria:

* Adults unable to give primary consent
* age less than 18 years
* pregnancy
* prisoners
* pre-existing cardiac or pulmonary disease
* infusion of inotropic drugs
* positive end expiratory pressure (PEEP) requirements \>8 cm H2O
* increased intra-abdominal pressure (e.g. planned surgical pneumoperitoneum or ascitis)
* intra-operative patient position other than supine

Primary outcomes:
measure: Airway Enthalpy
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis Health System
state: California
Study officials:
affiliation: Professor, Anesthesiology & Pain Medicine
name: Neal Fleming, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: