louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03200353: Evaluation of Sores Treatment by Oxygenotherapy
Official title: Evaluation of Sores Treatment by Oxygenotherapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ulcer Venous
Lead sponsor: Fondation Hôpital Saint-Joseph
Sponsor class: OTHER
First posted: 2017-06-27
Enrollment: 31
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: Patient with chronic wounds are selected to receive NATROX system ; it's a continous diffusion of oxygen therapy delivery system. This one is put on the wound during a consultation at the hospital and will be followed in home medical care. Every 2 days a nurse renew the application at home and patient recharge the system with oxygen every day.

The complete treatment is prescribe for 4 weeks and at the end patient comes to hospital to have a consultation with the doctor.


Eligibility criteria: Inclusion Criteria:

* age \> 18 years
* accepted to participate
* Patients followed in vascular medicine and entrusted to the home medical care for the bandages of chronic wounds with apathetic ulcers, not presenting of granulation tissue on their surface

Exclusion Criteria:

* infected ulcers
* necrosed ulcers
* Arterial ulcers requiring a revascularisation.
* Ulcers whose surface is superior in 10x10 cm.

Primary outcomes:
measure: number of patients received the entire treatment (3 to 4 weeks of oxygenotherapy) in home medical care
timeFrame: 4 weeks
Secondary outcomes:
measure: percentage of patients who can receive skin graft after the therapy
timeFrame: 1-2 month
measure: percentage of patient who stopper the treatment
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupe Hospitalier Paris Saint Joseph
state: Ile-de-France
Study officials:
affiliation: Fondation Hôpital Saint-Joseph
name: Isabelle P LAZARETH, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01210053: Sunitinib as Maintenance Therapy in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
Official title: This Phase II Trial is Studying Sunitinib to See How Well it Works When Given as Maintenance Therapy in Treating Patients With Stage III or Stage IV Non-small Cell Lung Cancer Which is Previously Treated With Combination Chemotherapy.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Non-small Cell Lung Cancer
Keywords: Non-Small Cell Lung Cancer
Lead sponsor: Third Military Medical University
Sponsor class: OTHER
First posted: 2010-09-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. It is not yet known whether sunitinib is effective in treating non-small cell lung cancer.

PURPOSE: This phase II trial is studying sunitinib to see how well it works when given as maintenance therapy in treating patients with stage III or stage IV non-small cell lung cancer which is previously treated with combination chemotherapy.

Detailed description: OBJECTIVES:

Primary

* To investigate the effect of sunitinib malate on the progression-free survival of patients with stage IIIB or IV non-small cell lung cancer Secondary
* To evaluate the toxicity of sunitinib when administered in the maintenance setting.
* To evaluate the additional response rate to sunitinib malate when administered in the maintenance setting.
* To evaluate the overall survival of patients treated with sunitinib. After completion of study treatment, patients are followed every 2 months for 1 year, every 6 months for 1 year, and periodically for 3 years.

Eligibility criteria: Inclusion Criteria:

* No evidence of symptomatic or untreated brain metastases, spinal cord compression, or carcinomatous meningitis
* Histologically or cytologically confirmed primary non-small cell lung cancer who have stable or responding disease after prior treatment with 3-6 courses of platinum -based therapy
* Not a candidate for combined modality therapy
* No cavitary lesions

Exclusion Criteria:

* Evidence of symptomatic or untreated brain metastases, spinal cord compression, or carcinomatous meningitis

Primary outcomes:
measure: Progression-free survival
timeFrame: 2 years
Secondary outcomes:
measure: • Grade and type of toxicity • 1-year survival rate • Response rate • Overall survival • Grade and type of toxicity • 1-year survival rate • Response rate • Overall survival
timeFrame: 2 years
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
state: Chongqing
Study officials:
affiliation: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
name: yang zhenzhou, doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03868553: Header Burden in Football (Soccer)
Official title: The Header Burden in Children's and Youth' Football (Soccer)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Header Frequencies, Head Injuries
Lead sponsor: Universität des Saarlandes
Sponsor class: OTHER
First posted: 2019-03-11
Enrollment: 480
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Football (soccer) playing children and adolescents

Brief summary: To assess the realistic magnitude of the header burden in children's and youth' football in eight European countries. In a cross-sectional observational design, one match of 60 different teams in each of the eight European countries were monitored via video recording throughout the second half of the regular season 2017/18 and the first half of the regular season 2018/19. Clubs with (female, male, or mixed) Under-10, Under-12 and female and male Under-16 teams were invited to participate. Header frequencies and types were analysed using standardized heading registration forms. Additionally, head injuries were recorded using standardized head injury registration forms.


Eligibility criteria: Inclusion Criteria:

* 1) officially registered in the football association
* 2) regular training participation
* 3) regular participation in official matches

Primary outcomes:
measure: Header frequency
timeFrame: 2018
Secondary outcomes:
measure: Head injuries
timeFrame: 2018
Other outcomes:
Locations:
city: Saarbrücken
country: Germany
facility: Saarland University
state: Saarland
Study officials:
References:
Clinical trial NCT00756353: Survey of Buprenorphine Use Among "Out of Care" Population in France (P04933)(COMPLETED)
Official title: Out of Care Patient Survey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Drug Addiction
Keywords: Heroin
Buprenorphine use
Lead sponsor: Indivior Inc.
Sponsor class: INDUSTRY
First posted: 2008-09-22
Enrollment: 600
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population in this survey includes drug users who are in the "out of care" population, found in various places (streets, railway stations) and via the "snow ball" technique.

Brief summary: This study was a survey of drug users who obtain buprenorphine from the black market and have used buprenorphine during the last month. Subjects were surveyed at various locations (streets, railway stations, etc.) with a few simple questions in order to describe the use of buprenorphine in this "out of care" population.

Detailed description: Participants were found from various places and using a "snow ball" technique.

Eligibility criteria: Inclusion Criteria:

* Drug users who have obtained buprenorphine only on the black market or both on black market and in pharmacy.

Exclusion Criteria:

* Patients who have obtained buprenorphine only from the pharmacy.

Primary outcomes:
measure: The objective of this survey is to describe quantitatively and qualitatively, the use of buprenorphine in the population who obtain buprenorphine only on black market or both on black market and in pharmacy.
timeFrame: Not Applicable, cross-sectional description.
Secondary outcomes:
measure: This survey will provide data on patients in regards to their own experience in drug addiction.
timeFrame: Not Applicable, cross-sectional description.
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00628953: Adult Asthmatics and Acid Reflux
Official title: A Randomized, Double-Blind, Parallel Group Multicenter Efficacy and Safety Phase IIB Pilot Study of Esomeprazole 40mg Bid Versus Placebo Bid in Adult Asthmatics Treated for 4 Months
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Keywords: Asthma
Acid Reflux
Nexium
Esomeprazole
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-03-05
Enrollment: 1400
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 assess the efficacy and safety of Nexium in the treatment of subjects with persistent asthma believed to have acid reflux as a contributory factor to control of their asthma.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of asthma
* Forced Expiratory Volume and Peak Expiratory Flow as defined by the protocol
* Daily use of inhaled GCS and/or leukotriene pathway modifier for greater than 3 months.
* Severe heartburn 3 days/week during the run-in period.

Exclusion Criteria:

* Subjects with a history of 3 sinus infections treated with antibiotics in the year prior to Visit 1.
* Any other significant disease or pathology judged to be clinically significant by the investigator

Primary outcomes:
measure: Effect on asthma symptoms as measured by changes in Peak Expiratory Flow morning & evening, Forced Expiratory Volume and asthma symptom scores
timeFrame: 4 weekly
Secondary outcomes:
measure: Safety as assessed by adverse event recording and clinical and laboratory measurements.
timeFrame: 4 weekly
Other outcomes:
Locations:
Study officials:
affiliation: Nexium Global Product Director, AstraZeneca
name: Paula Fernstrom
role: STUDY_DIRECTOR
References:
Clinical trial NCT06350253: Comparison Of Measured To Predicted Resting Metabolism
Official title: Comparison Of Measured To Predicted Resting Metabolism
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Body Weight
Lead sponsor: Ohio University
Sponsor class: OTHER
First posted: 2024-04-05
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men \& women, aged 18-60 in cohorts by age: 18-24, 24-29, 30-39, 40-49, and 50-60 years of age

Brief summary: The purpose of this study is to compare RMR values from the BIA, predicted equations, and indirect calorimetry.

Detailed description: Resting metabolic rate (RMR) describes the number of calories a person utilizes while at rest. The gold standard measurement is via inspired and expired air using a metabolic cart. However, researchers have established estimation equations and the use of body composition analysis to predict RMR when a metabolic cart is unavailable. The accuracy of the predicted equations and whole-body bioelectrical impedance (BIA) machines that produce this data is unknown. Therefore, the purpose of this study is to compare RMR values from the BIA, predicted equations, and indirect calorimetry.

Aim 1: to compare measured RMR from indirect calorimetry to values provided by the InBody 770 BIA machine and to established gender and age-appropriate prediction equations.

Aim 2: to compare RMR measured from indirect calorimetry using a metabolic cart (Gold Standard) to the Medgem handheld indirect calorimeter (FDA approved device).

Eligibility criteria: Inclusion Criteria:

* Men \& women, aged 18-60

Exclusion Criteria:

* Have any known or suspected metabolic diseases such as diabetes, thyroid disorder, or high cholesterol
* Have any known or suspected cardiovascular or pulmonary diseases such as hypertension
* Are currently on beta blockers, taking antihypertensives, or antidepressants
* Current smoker or quit less than a year ago
* Unwilling to provide finger stick and urine sample

Primary outcomes:
measure: Resting metabolic rate
timeFrame: day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Athens
country: United States
facility: Ohio University Exercise Physiology Lab
state: Ohio
Study officials:
References:
Clinical trial NCT06783153: Efficacy and Safety of Adjunctive Use of Rifaximin In Preventing Radiotherapy-induced Diarrhea in Cancer Patients
Official title: Efficacy and Safety of Adjunctive Use of Rifaximin In Preventing Radiotherapy-induced Diarrhea in Cancer Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Radiotherapy Induced Diarrhea
Acute Radiation Enteritis
Prostate Cancer
Cervical Adenocarcinoma
Bladder (Urothelial, Transitional Cell) Cancer
Rectal Adenocarcinoma
Pelvic Radiotherapy
Rifaximin
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2025-01-20
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Preclinical data indicate that rifaximin could be repurposed as a novel strategy for preventing and reducing the severity of gastrointestinal damage, particularly diarrhea, that results from pelvic irradiation. So, The aim of the work is to investigate the impact of Rifaximin on the incidence and severity of radiotherapy-induced diarrhea in cancer patients undergoing pelvic irradiation with or without chemotherapy.


Eligibility criteria: Inclusion Criteria:

* Individuals who are 18 years of age or older and have been diagnosed with non metastatic pelvic cancers.
* Patients who are undergoing curative intent radiotherapy with or without chemotherapy treatment.

Exclusion Criteria:

* Patients who have a record of intestinal resection in their medical history.
* Patients with a medical background of irritable bowel syndrome.
* Patients with a history of inflammatory bowel disease.
* Patients who regularly take anti-diarrheal medications before commencing radiotherapy.
* Patients experiencing diarrhea at the outset of the study.
* Patients with compromised immune systems, such as those who are HIV positive or using immunosuppressive medications.
* Pregnant or lactating woman.
* Patients allergic to rifamycin.

Primary outcomes:
measure: The difference in the incidence and severity of radiotherapy induced diarrhea grade 2 or more according to Common Terminology Criteria for Adverse Events (CTCAE)in cancer patients undergo pelvic irradiation.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University
state: Province
Study officials:
References:
Clinical trial NCT01072253: Quality of Life of Eye Amputated Patients in Denmark
Official title: Quality of Life of Eye Amputated Patients in Denmark
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Eye Cancer
Painful Blind Eye
Panophthalmia
Traumas
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Velux Fonden
name: The Danish Eye Research foundation
First posted: 2010-02-22
Enrollment: 152
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: eye clinic Rigshospitalet, Denmark. Rigshospitalet is a public, regionalized and national specialized hospital with a recruitment area of Eastern Denmark (approximately 2 million people). Nearly all cases of eye amputation and cancer in the eye region in Eastern Denmark are performed at Rigshospitalet

Brief summary: The purpose of this study is to evaluate eye amputated patients health related quality of life, perceived stress, self-rated health, labour marked participation and socio-economic position.

The investigators hypothesis is that quality of life, perceived stress and self- rated health of many eye amputated patients are drastically changed. Eye amputation has a marked negative influence on labour marked participation and socio-economic position of the patients.


Eligibility criteria: Inclusion Criteria:

* Inclusion criteria were operation for evisceration, enucleation, orbital exenteration or secondary implantation of an orbital implant during the period 1996-2003. 267 patients were in 2005 invited to a clinical investigation and of those 173 accepted.
* Included in this study were patients who came to the clinical investigation, who accepted to receive questionnaires and were alive in 2008.

Exclusion Criteria:

* Dead
* Below 18 years
* Left the country
* Living at Greenland or the Faeroe Islands

Primary outcomes:
measure: Health related quality of life
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Neuroscience and pharmacology, section of eye pathology
state: Seland
Study officials:
affiliation: University of Copenhagen
name: Marie Louise R Rasmussen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Copenhagen
name: Peter B Toft, MD, DMSc
role: STUDY_DIRECTOR
References:
citation: Roed Rasmussen ML, Prause JU, Johnson M, Toft PB. Phantom eye syndrome: types of visual hallucinations and related phenomena. Ophthalmic Plast Reconstr Surg. 2009 Sep-Oct;25(5):390-3. doi: 10.1097/IOP.0b013e3181b54b06.
citation: Rasmussen ML, Prause JU, Johnson M, Kamper-Jorgensen F, Toft PB. Review of 345 eye amputations carried out in the period 1996-2003, at Rigshospitalet, Denmark. Acta Ophthalmol. 2010 Mar;88(2):218-21. doi: 10.1111/j.1755-3768.2008.01435.x. Epub 2008 Dec 24.
Clinical trial NCT01204853: A 12 Week Safety And Efficacy Study Of Sitaxentan Sodium In Japanese Pulmonary Arterial Hypertension Patients
Official title: A Phase 3, Multi-Center, Open Label Study To Evaluate The Safety And Efficacy Of Sitaxentan Sodium In Japanese Subjects With Pulmonary Arterial Hypertension
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Hypertension, Pulmonary
Keywords: sitaxentan sodium hypertension
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-09-17
Enrollment: 2
Sex: ALL
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The safety and efficacy at 100 mg once daily for oral dose of sitaxentan sodium were demonstrated in the STRIDE clinical trial program. Sitaxentan sodium was approved in the EU, Canada and Australia. In this study, the safety and efficacy after administrations of sitaxentan sodium at a dose of 100 mg alone or in combination with another medication will be investigated in Japanese PAH patients.


Eligibility criteria: Inclusion Criteria:

* Has a current diagnosis of symptomatic PAH
* Has 6MWT distances from 150 to 450 meters and distance

Exclusion Criteria:

* Previous exposure to an endothelin receptor antagonist
* Has uncontrolled systemic hypertension as evidenced by sitting systolic blood pressure \>160 mm Hg or sitting diastolic blood pressure \>100 mm Hg at Screening.
* Has hypotension defined as systolic arterial pressure \<90 mm Hg after sitting for 5 minutes at Screening.

Primary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: 12 weeks
measure: Change From Baseline in 6-minute Walk Distance
timeFrame: 12 weeks
Secondary outcomes:
measure: Change From Baseline in WHO Functional Class
timeFrame: 12 weeks
measure: Number of Participants With Haemodynamics Parameters
timeFrame: 12 weeks
measure: Change From Baseline in N-amino Terminal Fragment of the Prohormone Brain Natriuretic Peptide (NT-pro BNP)
timeFrame: 12 weeks
measure: Clinical Worsening
timeFrame: 12 weeks
measure: Number of Participants With Pharmacokinetic (PK) Parameters at Steady State
timeFrame: pre-dose at Week 2, 4, 8, and pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24 hours post-dose at Week 12 or study termination
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Pfizer Investigational Site
state: Aichi
city: Shinjyuku-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT04484753: Validation of iPelvis App for Female Pelvic Floor Dysfunction
Official title: Validation of the iPelvis Mobile Application for Pelvic Physiotherapy in Women With Female Pelvic Floor Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Female Sexual Dysfunction
Urinary Incontinence
Keywords: urinary incontinence
female sexual dysfunction
quality of life
adherence
pelvic physiotherapy
post-partum
Lead sponsor: Faculdade Inspirar
Sponsor class: OTHER
First posted: 2020-07-24
Enrollment: 138
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The iPelvis app aims to improve adherence to pelvic physiotherapy on women with pelvic floor related dysfunctions, such as urinary or fecal incontinence, sexual dysfunction, etc.

Detailed description: Urinary dysfunctions are widely discussed because they cause problems in social, emotional, sexual life and the quality of life of incontinent women. The overall objective of this research is to evaluate the use of the Application. Ipelvis in women with urinary incontinence. This is a longitudinal study of the type randomized controlled trial. Women with urinary incontinence of urgency, effort and effort will be evaluated and treated. Frequently asked questions, questions and answers, Quality of Life Questionnaires, Health Requirements, ICIQ-SF, ICIQ-OAB, FSFI and evaluation of pelvic, manual and electromyographic floor musculature function. As volunteers are drawn in four groups (Group I: Household Exercise Sheet / Group II: Ipelvis application / Group III: Household Exercise Sheet + Pelvic Physiotherapy / Group IV Ipelvis Application + Pelvic Physiotherapy).

Eligibility criteria: Inclusion Criteria:

* Women with urinary incontinence by urodynamics, stress and mixed urinary incontinence, aged between 18 and 59 years, who have cognitive ability, have a compatible cell to install the Ipelvis application and who sign the Informed Consent Form.

Exclusion Criteria:

* Pregnant women, women up to six months postpartum, women with prolapse greater than stage III by Pelvic Organ Prolapse - Quantification (POP-Q), women with urinary tract infection, women with pelvic pain Performing therapies offered or having undergone pelvic surgery within a period of less than six months; With a pacemaker or contraceptive device (IUD); Women with intrapelvic tumor.

Primary outcomes:
measure: International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF)
timeFrame: 3 Months
Secondary outcomes:
measure: Kings Health Questionnaire (KHQ)
timeFrame: 3 Months
measure: The Female Sexual Function Index (FSFI)
timeFrame: 3 Months
Other outcomes:
Locations:
Study officials:
affiliation: Faculdade Inspirar
name: Rogério Fraga
role: STUDY_DIRECTOR
References: