louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00158691: Intravenous Versus Subcutaneous Amifostine in Prevention of Xerostomia After RT for Head and Neck Carcinomas
Official title: A Randomized Phase III Study Comparing Intravenous Versus Subcutaneous Administration of Amifostine in Prevention of Xerostomia for Patients Receiving Radiotherapy for Head and Neck Carcinomas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Head and Neck Cancer
Keywords: Head and Neck cancer
Radiotherapy
Xerostomia
Randomized trial
Lead sponsor: Groupe Oncologie Radiotherapie Tete et Cou
Sponsor class: OTHER
Collaborators: name: Schering-Plough
First posted: 2005-09-12
Enrollment: 296
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Prospective randomized study in order to compare intravenous versus subcutaneous administration of amifostine in patients receiving radiotherapy for head and neck cancer. Salivary flow will be evaluated during few years after the treatment by a clinical evaluation, the measure of the weight of saliva and a patient benefit questionnaire cotation.

Detailed description: Prospective randomized study in order to compare intravenous (IV) versus subcutaneous (SC) administration of amifostine in patients receiving radiotherapy for head and neck cancer. IV administration of amifostine is 200 mg/m2/day in a short 3-min infusion 15 to 30 min before each fraction of radiotherapy. SC administration is 500mg/day in two slow 1.25 ml injections at two different sites 20 to 60 min before each radiotherapy fraction. Procedure requires antiemetic treatment and blood pressure monitoring in both arms.

Eligibility criteria: Inclusion Criteria:

* newly diagnosed squamous cell head and neck cancer
* inclusion of at least 75% of both parotid glands within radiation fields that would receive at least 40 Gy
* Neutrophils ≥ 2000 / mm, Platelets ≥ 100,000 / mm3, Creatinine \< 130 / mmol.L-1, Transaminase ≤ 3 x upper limit

Exclusion Criteria:

* Distant metastases
* Prophylactic use of pilocarpine
* Concomitant chemotherapy

Primary outcomes:
measure: Late xerostomia rate
Secondary outcomes:
Other outcomes:
Locations:
city: Nantes
country: France
facility: Centre Régional de Lutte contre le Cancer de Nantes-Atlantique
Study officials:
affiliation: Centre Régional de Lutte contre le Cancer de Nantes-Atlantique
name: Etienne Bardet, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bardet E, Martin L, Calais G, Tuchais C, Bourhis J, Rhein B, Feham N, Alphonsi M. Preliminary data of the GORTEC 2000-02 phase III trial comparing intravenous and subcutaneous administration of amifostine for head and neck tumors treated by external radiotherapy. Semin Oncol. 2002 Dec;29(6 Suppl 19):57-60. doi: 10.1053/sonc.2002.37348.
Clinical trial NCT03939091: Ultrasonographic Versus Renographic Parameters in Prediction of Early Success After Pyeloplasty in Children
Official title: Ultrasonographic Versus Renographic Parameters in Prediction of Early Success After Pyeloplasty in Children. A Prospective Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pyeloplasty
Pediatrics
Renogram
Ultrasonography
Keywords: Ultrasonography
Pyeloplasty
Renogram
Follow up
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2019-05-06
Enrollment: 100
Sex: ALL
Minimum age (years): 6
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: To study the predictive value of ultrasonographic (USG) parameters in the form of anteroposterior diameter , calyceal dilatation , calyx-to-parenchyma ratio , renal length , renal width , pelvis-to-cortex ratio (PCR) and parenchymal thickness versus renographic parameters in the form of T1/2 , differential renal function (DRF) and Tissue tracer transit (TTT) for early detection of children at risk of recurrent obstruction post unilateral pyeloplasty.


Eligibility criteria: Inclusion Criteria:

* patients who will be scedueled for pyeloplasty

Exclusion Criteria:

* bilateral pathology
* Pelvi-ureteric junction obstruction (PUJO) in a solitary kidney
* other associated anomalies

Primary outcomes:
measure: evaluate predictive value of ultrasonographic parameters for early detection of recurrent obstruction
timeFrame: 30 months
measure: evaluate predictive value of ultrasonographic parameters for early detection of decrease renal function
timeFrame: 30 months
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Urology and nephrology center
state: Outside U.S./Canada
Study officials:
References:
Clinical trial NCT02839291: Evaluation of Medical Practice in the Management of Bone Metastases After Injectable Bone Antiresorptive Treatment, and Its Influence on Quality of Life
Official title: Evaluation of Medical Practice in the Management of Bone Metastases After Injectable Bone Antiresorptive Treatment, and Its Influence on Quality of Life
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Tumor With Bone Metastasis
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2016-07-20
Enrollment: 148
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: To evaluate the current medical practice and its influence on health-related quality of life, in patients who are treated with injectable bone antiresorptive drugs (biphosphonates or denosumab) for at least one year.

Detailed description: This protocol will evaluate the pursuit of injectable bone antiresorptive treatments or their switch to oral biphosphonates, or treatment stop, in the contexte of medical practice.

The primary end-point is the health-related quality of life (QoL). Secondary endpoints are safety, overall survial, the impact of toxicities of the treatment on QoL, and the description of supportive care.

Eligibility criteria: Inclusion Criteria:

* Patient with histologically proven tumor with bone metastasis, single or multiple (with or without metastasis extra-osseous)
* Patients treated with injectable bone antiresorptive therapy for 12 months or more
* Signed written informed consent

Exclusion Criteria:

* patient with any medical or psychiatric condition or disease which would make the patient inappropriate to complete quality of life questionaries
* patient under guardianship, curator or under the protection of justice, pregnant or breast-feeding women

Primary outcomes:
measure: evaluation of 4 targeted dimensions of the EORTC-QLQ-BM22 quality of life questionarie
timeFrame: to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Besançon
country: France
facility: Centre Hospitalier Régional Universitaire de Besançon
city: Montbéliard
country: France
facility: Hôpital Nord Franche-Comté
Study officials:
References:
Clinical trial NCT03259191: Anti-reflux Mucosectomy (ARMS) is a Useful Therapy for Refractory Gastroesophageal Reflux Disease (RGERD)
Official title: Department of Gastroenterology, Zhongda Hospital
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Refractory Gastroesophageal Reflux Disease
Keywords: Anti-reflux mucosectomy,refractory gastroesophageal reflux disease,safety,efficacy
Lead sponsor: Zhongda Hospital
Sponsor class: OTHER
First posted: 2017-08-23
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Anti-reflux mucosectomy (ARMS) may be a new therapy for refractory gastroesophageal reflux disease (RGERD). The aim of the present study is to explore the safety and efficacy of ARMS.


Eligibility criteria: Inclusion Criteria:

1. Full sufficiency in literacy
2. Be off proton pump inhibitor, antacids and prokinetics ≥ 2 weeks
3. Refractory gastroesophageal reflux disease

Exclusion Criteria:

1. Severe heart, lung, and cerebrovascular disease
2. Severe hematopoietic system disease
3. Abnormal blood coagulation function
4. Oropharyngeal abnormalities
5. Severe spine malformation
6. In pregnancy and lactation at present, or plan to become pregnant within 2 years
7. Severe inflammation or huge ulcers in stomach
8. Mental and psychological disorde

Primary outcomes:
measure: Improvement of symptoms
timeFrame: 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months
Secondary outcomes:
measure: Complications of ARMS
timeFrame: 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Zhongda Hospital Southeast University
state: Jiangsu
Study officials:
affiliation: Zhongda Hospital
name: Huiping Wang
role: STUDY_CHAIR
References:
Clinical trial NCT01704391: Haemodynamic Response to Aortic Surgery
Official title: Haemodynamic Response to Aortic Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Aneurysm, Abdominal
Aortic Diseases
Acute Kidney Injury
Lead sponsor: Sygehus Lillebaelt
Sponsor class: OTHER
First posted: 2012-10-11
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 10 patients sceduled for elective open operation for aortic aneurysm disease and 10 patients sceduled for elective open operation for aortic occlusive disease

Brief summary: Open elective abdominal aortic surgery is a high risk procedure involving clamping of the aorta. Indications include abdominal aortic aneurysm (AAA) or aortic occlusive disease (AOD) causing lower limb ischaemia.

These patients are often regarded as one entity in postoperative study settings. However, previous studies indicate that risk profiles, inflammatory activity, and haemodynamic capacity may differ between these groups. The first aim of this study was to evaluate postoperative ICU-requirements after open elective abdominal aortic surgery, hypothesising that AAA-patients had longer ICU-stays and needed more mechanical ventilation or acute dialysis than did patients with AOD.

The investigators see a relatively high incidence of postoperative acute kidney injury (AKI) following aortic surgery. Neutrophil Gelatinase Associated Lipocalcin (NGAL) may be useful in the early diagnosis of postopeative AKI. However, NGAL is also known as a marker of inflammatory activation. The ischaemia-reperfusion injury and subsequent inflammatory response to aortic cross clamping may per se induce a rise in NGAL despite intact renal function. Therefore NGAL may not be a reliable marker of AKI after AAS.

The second aim of this study is to describe the changes in NGAL after AAS in patients with and without postoperative dialysis-dependent AKI.


Eligibility criteria: Inclusion Criteria:

* CT verified aortic aneurysm or aortic occlusive disease

Exclusion Criteria:

* age\<18 y
* contraindications to the use of oesophagus doppler monitor, eg mycosis, perforation, stenosis.

Primary outcomes:
measure: ICU length of stay
timeFrame: 24 hours postoperatively
measure: Post-operative need for dialysis
timeFrame: 72 hours postoperatively
Secondary outcomes:
measure: Hemodynamic peroperative changes in AAD vs AOD
timeFrame: After anaesthesia induction, 10 minutes after aortic cross-clamping, 10 minutes after reperfusion, end of surgery
Other outcomes:
Locations:
city: Kolding
country: Denmark
facility: Lillebaelt Hospital, Kolding Hospital
Study officials:
References:
Clinical trial NCT04000191: Ice as an Adjunct for Local Anesthesia During Anorectal Surgeries
Official title: Numb the Bum: Ice as an Adjunct for Local Anesthesia During Anorectal Surgeries
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Anesthesia, Local
Keywords: ice
elective anorectal surgery
anesthesia care
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
First posted: 2019-06-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine, among patients receiving elective anorectal surgery, does application of ice to the perianal area prior to the procedure, lead to use of decreased amounts of intravenous (IV) anesthesia? Anorectal surgeries for hemorrhoids, fistulas and fissures are done on an outpatient basis under monitored anesthesia care. This means patients get sedating medications through an IV but often do not require intubation. The difficulty with monitored anesthesia is balancing patient comfort against the risk of apnea (not breathing due to over sedation). Application of ice to the perianal area may help increase patient comfort, decrease the amounts of medications given for sedation and therefore decrease risk and increase recovery from the anesthesia.

Detailed description: The study design will be a randomized control trial of adults undergoing elective surgery for hemorrhoids, fistulas, perianal/perirectal abscess and anal fissure. Participants will be randomized in a 1 to 1 ratio using a random number generator to two arms to the study - usual care vs. usual care plus ice to numb the anal area prior to incision.

The outcomes will be measured the same day as the surgery. Prior to leaving the operating room the anesthesia team will share with the surgeon the amount of each drug they administered. A comfort score will be recorded by the study personnel in the recovery area prior to discharge for each participant.

Eligibility criteria: Inclusion Criteria:

-Patient with planned minor elective colorectal surgery (eg for hemorrhoids, perianal abscess, fistula in ano, anal fissure, pilonidal cysts, or anal condyloma)

Exclusion Criteria:

-Patient who requires general anesthesia as part of the initial anesthesia plan

Primary outcomes:
measure: Amount of drugs administered to each participant
timeFrame: Within 1 days after each surgical procedure
Secondary outcomes:
measure: Participant self pain assessment in the recovery area
timeFrame: Within 2 hours after each surgical procedure
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Boston Medical Center
name: Uma R Phatak, MD MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05660291: A Study of Time Restricted Eating in Obese Adults
Official title: Effects of Time Restricted Eating on Obesity: Comparing Windows of Eating to Achieve Weight Loss in Overweight and Obese Adults; a Pilot Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Overweight
Keywords: Body Mass Index (BMI) ≥ 25 kg/m^2
Early and late time-restricted eating
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2022-12-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this pilot study is to understand the difference between early and late time-restricted eating on weight and body mass index (BMI), and evaluate the barriers encountered and the effect on quality of life.


Eligibility criteria: Inclusion Criteria:

* Ability to read and understand English
* BMI ≥ to 25.

Exclusion Criteria:

* Regularly skip meals.
* Are unwilling or unable to limit eating to an 8-hour window.
* Have a current Melanoma or cancer diagnosis.
* Currently breastfeeding.
* Pregnant, or planned to be pregnant within 3 months.
* Are taking insulin or sulfonylurea drugs.
* Are taking weight loss medications or had weight loss surgery within the last year.
* Have a history of eating disorders.

Primary outcomes:
measure: Change in weight
timeFrame: Baseline, 12 weeks
Secondary outcomes:
measure: Change in Hemoglobin A1c
timeFrame: Baseline, 12 weeks
measure: Change in fasting glucose
timeFrame: Baseline, 12 weeks
measure: Change in total cholesterol
timeFrame: Baseline, 12 weeks
measure: Change in Low-density lipoprotein (LDL) cholesterol
timeFrame: Baseline, 12 weeks
measure: Change in High-density lipoprotein (HDL) cholesterol
timeFrame: Baseline, 12 weeks
measure: Change in Triglycerides
timeFrame: Baseline, 12 weeks
measure: Subjects to complete study
timeFrame: Baseline, 12 weeks
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic Minnesota
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Bradley Bohn, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06132191: Expanded Access Use of Cemiplimab in Patients With Solid Tumors
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2023-11-15
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: Provide expanded access of cemiplimab in patients with solid tumors

Detailed description: Compassionate Use requests are only being considered in response to Individual Patient Investigational New Drug (IND) applications. Availability will depend on location.


Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00568191: Stratus Versus Cirrus OCT in AMD
Official title: Reliability of Threshold Algorithm in Age-Related Macular Degeneration: Stratus Versus Cirrus OCT
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Age-Related Macular Degeneration
Choroidal Neovascularization
Keywords: Age-related macular degeneration
choroidal neovascularization
Stratus OCT
Cirrus OCT
Lead sponsor: The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
Sponsor class: OTHER
First posted: 2007-12-05
Enrollment: 100
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged \> 55 years of either sex presenting with age-related macular degeneration

Brief summary: The Cirrus OCT provides due to the spectral domain technology a 2-fold resolution than Stratus OCT generated in a comparable amount of time. Due to this higher resolution the retinal surface and the retinal pigment epithelium can be identified more clearly, a significantly reduced number of algorithm failures is expected


Eligibility criteria: Inclusion Criteria:

* Age\>55 years
* Age-related macular degeneration

Exclusion Criteria:

* Not consented patients

Primary outcomes:
measure: Number of algorithm failures assessed by Stratus OCT versus Cirrus OCT in the horizontal central line
timeFrame: only 1 examination
Secondary outcomes:
measure: Number of algorrithm failures in Stratus versus Cirrus OCT assessed in the whole scan
timeFrame: 1 examination
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Ludwig Boltzmann Institute for Retinology and Biomicroscopic Lasersurgery
Study officials:
affiliation: Ludwig Boltzmann Institute of Retinology and Biomicroscopic Lasersurgery
name: Ilse Krebs
role: PRINCIPAL_INVESTIGATOR
References:
citation: Krebs I, Falkner-Radler C, Hagen S, Haas P, Brannath W, Lie S, Ansari-Shahrezaei S, Binder S. Quality of the threshold algorithm in age-related macular degeneration: Stratus versus Cirrus OCT. Invest Ophthalmol Vis Sci. 2009 Mar;50(3):995-1000. doi: 10.1167/iovs.08-2617. Epub 2008 Nov 21.
Clinical trial NCT00347191: Relationship Between Central Corneal Thickness and Intraocular Pressure Measures Instruments.
Official title: Phase 4 Study Evaluating the Relationship Between Intraocular Pressure and Central Corneal Thickness Using Various Instruments in Ocular Hypertension, Normal-tension Glaucoma, Primary Open Angle Glaucoma, Keratoconus and Normal Eyes.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glaucoma
Glaucoma, Open Angle
Ocular Hypertension
Keratoconus
Keywords: Corneal thickness
Intraocular pressure
Instrumentation
Glaucoma
Keratoconus
Lead sponsor: Aston University
Sponsor class: OTHER
First posted: 2006-07-04
Enrollment: 1000
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: Clinical diagnosis of glaucoma, open angle; ocular hypertension; glaucoma (low-tension); keratoconus and other healthy volunteers.

Brief summary: The purpose of this study is to evaluate the relationship between intraocular pressure and central corneal thickness using various instruments in ocular hypertension, normal-tension glaucoma, primary open angle glaucoma, keratoconus and normal eyes.

Detailed description: The purpose of this study is to evaluate the relationship between intraocular pressure and ultrasound pachymetry measured central corneal thickness using Goldman tonometry and PASCAL instruments.

Patient groups examined include:

ocular hypertensives normal-tension glaucoma primary open angle glaucoma keratoconus control normal eyes

Eligibility criteria: Inclusion Criteria:

Adults over the age of 18 years Clinical diagnosis of glaucoma, open angle; ocular hypertension; glaucoma (low-tension); keratoconus and other healthy volunteers.

Exclusion Criteria:

Children under the age of 18 years Adults with learning disabilities Adults who are unconscious or severely ill Adults who have known terminal illness Adults in emergency situations Adults with dementia Prisoners Young offenders Those who could be considered to have a dependant relationship with the investigator (i.e. those in care homes or medical students) Other vulnerable groups

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: Solihull Hospital
state: West Midlands
Study officials:
affiliation: Birmingham and Midland Eye Centre
name: Sunil Shah, MD FRCOphth
role: PRINCIPAL_INVESTIGATOR
References: