louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00213811: Bardet-Biedl Syndrome Study: Clinical and Genetic Epidemiology Study in Adults
Official title: Bardet-Biedl Syndrome: Clinical and Genetic Epidemiology Study in the Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bardet-Biedl Syndrome
Orphan Diseases
Keywords: Bardet-Biedl syndrome, retinitis pigmentosa, obesity, genes
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2005-09-21
Enrollment: 40
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: This study is based on the study of the natural history of a rare disorder: the Bardet-Biedl syndrome (BBS) (which is associated with retinitis pigmentosa, polydactyly, cognitive impairment, obesity, and kidney failure). The clinical, biological, and radiological features of adult patients are studied. In parallel, a molecular study is performed on the known genes to date (8 genes from BBS1 to BBS8) and to identify new genes involved. The parts of the study are combined in a phenotype-genotype correlation study.


Eligibility criteria: Inclusion Criteria:

* Adult (age over 16 years old)
* At least 3 of the five major criteria (retinitis pigmentosa, obesity, polydactyly, cognitive impairment, and kidney disorder) and/or BBS mutations identified

Primary outcomes:
measure: Outcome evaluated end 2005 and 2006
measure: Clinical results (natural history, phenotype-genotype correlations, genetic epidemiology, new genes identification
Secondary outcomes:
measure: This study may lead to further clinical investigations according to the results (new protocol to be established) and to further molecular investigations
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Hélène Dollfus
Study officials:
affiliation: Fédération Génétique
name: Hélène Dollfus, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: IGBMC
name: J-Louis Mandel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CIC Strasbourg
name: Pascal Bousquet, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CIC Strasbourg
name: Christian Brandt, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CIC Strasbourg
name: Catherine Arnold, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Unité de Génétique Robert Debré
name: Alain Verloes, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CIC Robet Debré
name: Régis Hanfard, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Service de Génétique Médicale/Bordeaux
name: Didier Lacombe, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CIC Bordeaux
name: Virginie Bernard, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Service de Génétique Médicale Lille
name: Sylvie Manouvrier, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05927311: Side Effects of Antibiotics in Bone and Joint Infections
Official title: Prospective Study : Side Effects of Antibiotics in Bone and Joint Infections
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bone Infection
Joint Infection
Keywords: antibiotherapy
adverse events
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2023-07-03
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient over 18 years of age with an osteoarticular infection requiring antibiotherapy of 6 weeks or more

Brief summary: Treatment for bone and joint infection (BJI) is not standardized, which allows a wide range of antibiotic therapy to potentially be given, most often in high doses over long periods of time. Patients are regularly confronted with the adverse effects of these antibiotics, which can lead to loss of adherence and treatment failure. The frequency, severity and impact on quality of life of the adverse effects of long-term antibiotics will be studied in a cohort followed for one year.

Detailed description: Treatment for bone and joint infection is not standardized, which allows a wide range of antibiotic therapy to potentially be given, most often in high doses over long periods of time. Patients are regularly confronted with the adverse effects of these antibiotics, which can lead to loss of adherence and treatment failure. Although patients with BJI receive regular follow-up, the impact of adverse events during treatments lasting more than a month is still poorly developed in the literature.

The frequency, severity and impact on quality of life of the adverse effects of long-term antibiotics will be studied in a cohort followed for one year.

The investigators believe that this study will improve the management of osteoarticular infections through a better understanding of the adverse effects associated with prolonged, high-dose antibiotic therapy, and encourage more multidisciplinary follow-up.

Eligibility criteria: Inclusion Criteria:

* Patient over 18 years of age
* Microbiologically proven osteoarticular infection with or without material, requiring antibiotic therapy (single or multiple) of 6 weeks or more
* Oral antibiotic therapy (minimum 4 weeks)

Exclusion Criteria:

* Opposition to data processing
* Patient under guardianship or trusteeship

Primary outcomes:
measure: Adverse reactions
timeFrame: Day 15
measure: Adverse reactions
timeFrame: Day 45
measure: Adverse reactions
timeFrame: Day 90
Secondary outcomes:
measure: Treatment failure
timeFrame: Day 15, day 45, day 90
measure: compliance of treatment
timeFrame: Day 15, day 45, day 90
measure: Drug interactions
timeFrame: Day 15, day 45, day 90
measure: EQ5D-5L
timeFrame: Day 365
Other outcomes:
Locations:
city: Tours
country: France
facility: University Hospital
Study officials:
affiliation: CHRU de Tours
name: Marion LACASSE
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02179411: Study of the Renal Perfusion in Healthy Volunteers and Renal Transplant Recipients During an Orthostatic Stress
Official title: Study of the Renal Perfusion in Healthy Volunteers and Renal Transplant Recipients During an Orthostatic Stress
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Safe Volunteers
Kidney Transplant Recipients
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
Collaborators: name: National Research Agency, France
First posted: 2014-07-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Autonomic nervous system contributes to the regulation of renal blood flow, affected by upright posture. Kidney transplantation implies sympathetic denervation. The aim of this study is to compare the renal vascular response in volunteers and renal graft recipients to an orthostatic stress induced by a head-up tilt test. Renal peripheral resistances are assessed by echo Doppler. The sympathetic nervous system activity is evaluated by plasma concentrations of catecholamine before and after the head-up tilt test.


Eligibility criteria: Inclusion Criteria:

- Healthy volunteers Male or female, within 18 and 50 year old Caucasian type

No cardiovascular risk factor:

Body mass index below 25 kg/m2 No smoking No dyslipidemia No diabetes No kidney disease or chronic renal failure No medication Electrocardiogram: normal Arterial blood pressure: normal Plasma creatinine clearance equivalent to 50mL/min or more (Cockroft formula) No proteinuria and no hematuria Able to understand the purpose of the study and sign the informed consent

- Renal graft recipients Male or female, within 18 and 50 year old Caucasian type About a year after the first renal allograft Body mass index below 25 kg/m2 No smoking No dylipidemia No diabetes Arterial blood pressure controlled Electrocardiogram: normal Plasma creatinine clearance equivalent to 50mL/min or more (Cockroft formula) Able to understand the purpose of the study and sign the informed consent

Exclusion Criteria:

* Healthy volunteers Creatinine clearance \< 50 mL/min (Cockroft formula) More than 2 syncopes a year Pregnancy
* Renal graft recipients Creatinine clearance \< 50 mL/min (Cockroft formula) Second renal allograft or more More than 3 antihypertensive treatments Beta adrenoreceptors blockers Acute rejection More than 2 syncopes a year

Primary outcomes:
measure: Evaluation of vascular resistance standing in renal transplant subjects compared with healthy subjects.
timeFrame: three years
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU d'Angers
Study officials:
References:
Clinical trial NCT03735511: A Real World Study of Apatinib in Treatment of Patients With Gastric Carcinoma
Official title: A Real World Study of Apatinib in Treatment of Patients With Gastric Carcinoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gastric Carcinoma
Lead sponsor: Henan Cancer Hospital
Sponsor class: OTHER_GOV
Collaborators: name: LinkDoc Technology (Beijing) Co. Ltd.
First posted: 2018-11-08
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Chinese patients who were pathologically or cytologically diagnosed gastric carcinoma and treated by apatinib.

Brief summary: The study was designed to evaluate the efficacy and safety of apatinib in the treatment of patients with gastric carcinoma.

Detailed description: The study is a real-world non-interventional retrospective study and will collect the original medical records of patients with gastric carcinoma treated with apatinib from 2015 to 2018 in Henan Cancer Hospital. Clinical data such as patient demographic, history of treatments, tumor biological characteristics and adverse events will be analyzed to evaluate the efficacy and safety of apatinib and explore the risk factors of prognosis in patients with gastric carcinoma.

Eligibility criteria: Inclusion Criteria:

1. Pathologically or cytologically confirmed gastric or residual gastric or gastroesophageal junction carcinoma;
2. Patients received apatinib treatment at least once.

Exclusion Criteria:

1. No specific exclusion criteria in this real world study.

Primary outcomes:
measure: Overall Survival
timeFrame: 2015-2018
Secondary outcomes:
measure: Objective Response Rate
timeFrame: 2015-2018
measure: Disease Control Rate
timeFrame: 2015-2018
measure: Progression-Free Survival
timeFrame: 2015-2018
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
Study officials:
References:
Clinical trial NCT05763511: Improved Diagnosis of Ovarian Cancer by Use of Circulating Tumor DNA as a Biomarker
Official title: Improved Diagnosis of Ovarian Cancer by Use of Circulating Tumor DNA as a Biomarker
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ovarian Neoplasms
Ovary Cancer
Ovarian Cysts
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
First posted: 2023-03-10
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients referred due to suspected ovarian cancer

Brief summary: This project investigates circulating tumor DNA (ctDNA) in patients with suspected ovarian malignancy.

We hypothesize that measurement of ctDNA in women with suspected ovarian cancer can improve the diagnostic efficiency for preoperative differentiation between benign and malignant masses.

Specifically, we hope to determine the diagnostic efficiency of ctDNA alone and ctDNA in combination with imaging modalities (ultrasonography, MRI, PET-CT) and CA 125 for preoperative differentiation between benign and malignant adnexal masses. Based on this, we hope to develop an improved diagnostic algorithm.

The mutational profile and relation to tumour type, stage, treatment response and prognosis will be explored.

Analyses of blood and tissue samples will be used to examine the disease development and biology.

Blood samples, tumour tissue and data on imaging modalities as well as CA 125 will be collected prospectively in consecutive women referred to Aarhus University Hospital.


Eligibility criteria: Inclusion Criteria:

* Suspected ovarian neoplasm
* Informed consent

Exclusion Criteria:

* Inability to give informed consent
* Previous ovarian cancer diagnosis

Primary outcomes:
measure: Diagnostic efficiency (reference: histopathological diagnosis)
timeFrame: 6 months
Secondary outcomes:
measure: Diagnostic efficiency of ctDNA combined with imaging (ultrasonography, MRI, PET-CT, CT, etc.) and CA 125 for differentiation of benign and malignant adnexal masses.
timeFrame: 6 months
measure: Disease stage
timeFrame: 6 months
measure: Treatment response
timeFrame: 2 years
measure: Survival
timeFrame: 5 years
measure: Tumour Biology
timeFrame: 6 months
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Department of Gynaecology and Obstetrics, Aarhus University Hospital
Study officials:
affiliation: University of Aarhus
name: Ina Marie Dueholm Hjorth, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03402828: Body PSOriasis: Long-term Relapse CONTROL
Official title: Body PSOriasis: Long-term Relapse Control in Patients With Psoriasis Vulgaris in Daily Clinical Practice of Russian Dermatologists.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psoriasis Vulgaris
Keywords: Topicals
Long-term
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
First posted: 2018-01-18
Enrollment: 764
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 with psoriasis vulgaris attending one of the participating outpatient dermatology clinics entering a phase of prevention of relapse of psoriasis symptoms.

Brief summary: This non-interventional study of real-life clinical practice strategies for long-term relapse control in patients with psoriasis vulgaris is planned to enroll 650 adult patients from 60-100 Russian dermatology sites and follow the patients for up to 52 weeks. The study will map actual strategies and focus on patients' and dermatologists' experience with the different topicals used, including unspecified products with and without active drugs.


Eligibility criteria: Inclusion Criteria:

* Patients planned to receive topical treatment of any kind to prevent relapse of symptoms
* Written informed consent

Exclusion Criteria:

* Contraindications to selected treatment
* Ongoing systemic treatment of psoriasis with steroids, anti-inflammatory drugs or phototherapy

Primary outcomes:
measure: Time of relapse
timeFrame: Up to 52 weeks
Secondary outcomes:
measure: Dermatology Life Quality Index
timeFrame: Up to 52 weeks
measure: PGA (physician's global assessment of symptoms)
timeFrame: Up to 52 weeks
measure: PsGA (patient's global assessment of symptoms)
timeFrame: Up to 52 weeks
Other outcomes:
Locations:
city: Kazan
country: Russian Federation
facility: The State Autonomous Foundation of Public Health "Republic Clinical Dermatovenereological Dispensary" of the Republic of Tatarstan
state: Tatarstan
Study officials:
affiliation: Leo Pharmaceutical Products LLC
name: Dmitry Petrunin, MD PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03284528: Does Placenta Pathology Predict Outcome of Neonates With Hypoxic Ischemic Encephalopathy?"
Official title: Does Placenta Pathology Predict Outcome of Neonates With Hypoxic Ischemic Encephalopathy?"
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asphyxia Neonatorum
Lead sponsor: University Children's Hospital, Zurich
Sponsor class: OTHER
First posted: 2017-09-15
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All newborn infants with a gestational Age \>35 weeks, fulfilling the inclusion criteria of perinatal asphyxia and hypoxic-ischaemic encephalopathy, born in Switzerland and treated in the University Hospital of Zurich with hypothermia therapy after birth

Brief summary: The histology of the placenta of newborn infants with perinatal asphyxia and hypoxic-ischaemic encephalopathy is analysed. There will be an evaluation if placenta could be a biomarker for neurodevelopmental outcome at 18-24 months of age.


Eligibility criteria: Inclusion Criteria:all newborn infants with APGAR \<5 at 10minutes, pH\<7.0, lactate \>12mmol/L, base excess \>16, resuscitation \>10min after birth, gestational age \>35 weeks and an encephalopathy -

Exclusion Criteria:

-

Primary outcomes:
measure: neurodevelopmental outcome at 18-24 month of Age
timeFrame: 7 years
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Children's hospital Zurich
Study officials:
affiliation: University Childrens's hospital of Zurich
name: Barbara Brotschi
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00622128: Preventing Aggressive Behavior in Demented Patients
Official title: Preventing Aggressive Behavior in Demented Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dementia
Aggression
Keywords: Behavioral Research
Dementia
Aggression
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2008-02-22
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to develop and pilot test and non-pharmacological intervention designed to prevent the occurence of aggression in persons with dementia.

Detailed description: An expert panel has met to review the investigators' prior work and literature to help create a non-pharmacological intervention designed to prevent the incidence of aggression. The investigators have created a manual based on prior work and expert input. Recruitment for pilot patients is now ready to begin. The purpose of the pilot will be to further adapt the intervention, assess feasibility, and examine recruitment options.

Eligibility criteria: Inclusion Criteria:

* diagnosis of dementia,
* caregiver

Exclusion Criteria:

* history of aggression,
* residence of nursing homes

Primary outcomes:
measure: Aggression prevention
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Michael E DeBakey VA Medical Center
state: Texas
Study officials:
affiliation: Michael E. DeBakey VA Medical Center
name: Mark E. Kunik, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00152828: Celebrex - Cervix: Celecoxib in the Treatment of Patients With Locally Advanced Carcinoma of the Cervix
Official title: A Phase I/II Trial of the Cyclooxygenase-2 Inhibitor Celecoxib in the Treatment of Patients With Locally Advanced Carcinoma of the Cervix
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Cervix Neoplasms
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: NCIC Clinical Trials Group
name: Princess Margaret Hospital, Canada
First posted: 2005-09-09
Enrollment: 31
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a phase I/II study to evaluate the safety and toxicity of celecoxib in combination with standard concurrent cisplatin and radiotherapy in women with locally advanced cervix cancer. In addition, we aim to determine the effect of celecoxib (Celebrex) on tumour oxygenation, interstitial fluid pressure, COX-2 levels, prostaglandin E2 levels, angiogenesis and apoptosis.


Eligibility criteria: Inclusion Criteria:

* Biopsy-proven carcinoma of the cervix, with visible/palpable tumours; FIGO stage T1B-3B, NO/1, MO, to be treated with definitive radiotherapy and chemotherapy
* ECOG performance status of 0, 1, or 2
* Adequate hematologic function; Granulocyte count greater than 1.5 x 109/L, Platelet count greater than 100 x 109/L
* Adequate organ function; Serum creatinine £ 1.25 x ULN, or a calculated creatinine clearance ³ 50 mL/min, Serum bilirubin £ 1.25 x ULN and AST/ALT £ 3xULN
* No prior treatment for cervix cancer
* Informed consent

Exclusion Criteria:

* Use of an NSAID in the 2 weeks prior to study enrollment
* Patients with an active malignancy at another site
* Patients with significant cardiac, renal, or pulmonary disease or any other medical conditions that may preclude radical therapy
* Patients who have significant history of ischaemic heart disease or stroke who would be deemed not suitable for cessation of their daily prophylactic aspirin
* Patients with history of peptic ulcer disease or previous NSAID related gastrointestinal bleeding
* Patients with hypersensitivity to NSAIDS or celecoxib, or sulfonamides
* Patients who unwilling or unable to give informed consent

Primary outcomes:
measure: Safety - Tolerance of concurrent celecoxib with standard cisplatin/radiotherapy
timeFrame: 1 year
Secondary outcomes:
measure: Objective changes in tumour oxygenation and IFP
timeFrame: 1 year
measure: Objective molecular marker response (COX-2, PGE2, VEGF, apoptosis)
timeFrame: 1 year
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
Study officials:
affiliation: Princess Margaret Hospital, Canada
name: Anthony Fyles, MD
role: PRINCIPAL_INVESTIGATOR
References: