louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00287690: Isoflavones and the Coronary Circulation in Men and Women With Coronary Artery Disease
Official title: The Effect of Genistein (Supro®) on Coronary Artery Diameter and Blood Flow in Men and Women With Coronary Heart Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Coronary Artery Disease
Keywords: arteries
blood flow
coronary artery disease
diet
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2006-02-07
Enrollment: 71
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate the effect of genistein administration on coronary arteries in humans. We will measure the size of a coronary artery and the speed and amount of blood flow in response after subjects have ingested Supro® drinks (a soy protein drink containing genistein).


Eligibility criteria: Inclusion Criteria:

* Aged 30-75 years
* Patients requiring diagnostic coronary angiography
* Presence of coronary artery disease on angiogram but with at least one non-obstructed (lesions \<70% narrowed compared with the adjacent normal part of the vessel) atheromatous vessel (confirmed at diagnostic cardiac catheterisation)
* Female patients must be postmenopausal (FSH\>40 IU/L)
* Willing to give informed, written consent

Exclusion Criteria:

* Age \<30 or \>75 years
* Allergy to radiographic contrast media
* Sino-atrial disease or significant bradycardia
* Concomitant medication with persantin (dipyridamole) or theophyllines
* Asthma
* Hypertension
* Left ventricular hypertrophy or dysfunction (clinical/ECG/echo/CXR)
* Female patients with FSH\<40 IU/L (postmenopausal)
* Female patients currently taking hormone therapy, or who have taken hormone therapy in previous 6 months
* Unwilling to give written informed consent
* Participation in another study within previous 60 days

Primary outcomes:
measure: Coronary Artery Diameter
timeFrame: Day 3-4 after Supro/placebo started.
measure: Coronary Blood Flow
timeFrame: Day 3-4 after Supro/placebo started.
Secondary outcomes:
measure: Serum Genistein Concentrations
timeFrame: Day 3 after Supro/placebo started.
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Royal Brompton & Harefield NHS Trust
Study officials:
affiliation: Imperial College London
name: Peter Collins, MD, FRCP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01670890: Efficacy and Safety of TMZ Plus CDDP in the Patients With Recurrent Malignant Gliomas
Official title: Efficacy and Safety of Salvage Treatment With Dose-dense TMZ Plus CDDP in the Patients With Recurrent Malignant Gliomas: a Multicentre,Prospective Clinical Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Malignant Gliomas
Keywords: temozolomide(TMZ)
cisplatin(CDDP)
recurrent malignant gliomas
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Tiantan Hospital
name: Tianjin Medical University General Hospital
First posted: 2012-08-22
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Temozolomide is the standard adjuvant chemotherapy of newly-diagnosis malignant gliomas.Cisplatin , a kind of chemotherapeutics, can enforce the anti-tumor effects of TMZ. Up to now, the prognosis of recurrent gliomas is very pessimistic and the standard treatment procedure has not been established yet.

The prospective,multicentre phase II clinical study is to evaluate the efficacy and safety of TMZ and CDDP in patients with recurrent malignant gliomas


Eligibility criteria: Inclusion Criteria:

* Written informed consent
* Age\>=18 and \<=70years old
* Histological diagnosis of malignant gliomas(WHO III or IV)
* The status of methylation of promotor of MGMT should be detected.
* The time to be enrolled should be more than 90 days after the irradiation.
* The patients with recurrent gliomas were treated with non-dose-dense TMZ therapy before enrollment.
* Performance status(Karnofsky index)\>=60
* Life expectancy more than 3 months

Exclusion Criteria:

* Ages:\< 18 years or \> 70 years
* Abnormal function of liver or renal(value more than 1.5 fold normal upper limit )
* Blood routing: Hb \< 100g/l， WBC \< 4.0×109/l; PLT \< 100×109/l
* Pregnant or lactating women
* Allergic to administered drugs
* Radiation treatment in the previous 90 days or stereotactic radiation surgery within 60 days before enrollment
* The patients with recurrent gliomas were treated with dose-dense TMZ therapy before enrollment.
* Life expectancy less than 3 months
* Participation in other clinical trials in the 90previous days before enrollment

Primary outcomes:
measure: over all survival
timeFrame: 1 year
Secondary outcomes:
measure: progression free survival
timeFrame: 6 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital Affiliated to Capital Medial University
state: Beijing
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
city: Tianjin
country: China
facility: Tianjin medical university general university
state: Tianjin
Study officials:
affiliation: Peking Union Medical College Hospital
name: wang renzhi, MD
role: STUDY_CHAIR
References:
Clinical trial NCT03759990: Tracheal Intubation in Morbidly Obese (BMI>35) and in Lean (BMI<30) Patients Using McGrath MAC X-Blade
Official title: A Comparison of Morbidly Obese and Lean
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity, Morbid
Keywords: videolaryngoscope
Airtraq
McGrath MAC
Morbid obesity
intubation
Lead sponsor: Kocaeli University
Sponsor class: OTHER
First posted: 2018-11-30
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: 80 lean (BMI\<35) and morbidly obese (BMI\>35) patients undergoing elective surgery were enrolled in this prospective ransomİzed study were intubated using McGrath MAC X-Blade. The demographic and airway variables of patients and insertion and intubation times with these dievices, need for optimisation maneuvers, hemodynamic changes and minör postoperative complications were recorded.

Detailed description: 80 lean (BMI\<35) and morbidly obese (BMI\>35) patients undergoing elective surgery were enrolled in this prospective ransomİzed study were intubated using McGrath MAC X-Blade. The demographic and airway variables of patients were recorded. Airway management variables Cormack-Lehan grades, insertion and intubation times, need for optimization maneuvers ( cricoid pressure, re-inserting, drawback) , hemodynamic changes in heart rate , blood pressure and minor postoperative complications such as sore throat, dysphasia, hoarseness were recorded.

Eligibility criteria: Inclusion Criteria: \> 18 age \<65 age

* bmı 35

  * undergoing elective surgery requiring endotracheal intubation

Exclusion Criteria: -pregnant

* \<18 and \>65 years of age
* bmı\<35
* upper respiratory tract infection past ten days

Primary outcomes:
measure: intubation time
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kocaeli
country: Turkey
facility: Kocaeli University School of Medicine
city: Kocaeli
country: Turkey
facility: Kocaeli University Medical Faculty
Study officials:
References:
Clinical trial NCT01607190: Biomarkers of Diabetic Retinopathy Progression
Official title: Biomarkers of Diabetic Retinopathy Progression.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes Mellitus
Mild Nonproliferative Diabetic Retinopathy
Keywords: type 2 diabetes mellitus
nonproliferative diabetic retinopathy
Lead sponsor: Association for Innovation and Biomedical Research on Light and Image
Sponsor class: OTHER
First posted: 2012-05-30
Enrollment: 200
Sex: ALL
Minimum age (years): 35
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: Patients with type 2 diabetes mellitus and mild nonproliferative diabetic retinopathy

Brief summary: The purpose of this study is to validate a predictive model of diabetic retinopathy progression in patients with diabetes mellitus type 2 patients to clinically significant macular edema (CSME) needing treatment either photocoagulation or intravitreal injections (ITV) using non-invasive techniques.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes mellitus
* Age over 35 years-old
* Non-proliferative diabetic retinopathy (Levels 20 to 35, according the ETDRS criteria)
* Best Corrected Visual Acuity \> 20/25 on the ETDRS chart
* Informed Consent

Exclusion Criteria:

* Previous laser therapy
* Other retinal vascular disease
* Glaucoma
* Recent intraocular surgery (in the last 6 months)
* Inadequate ocular media and/ or pupil dilatation that do not permit good quality fundus photography (e.g. cataract)
* HbA1C \> 11 % at the Screening
* Subject that has a condition or that is in a situation which may put him/her at significant risk, may confound the study results or may interfere significantly with his/ her participation in the study.

Primary outcomes:
measure: CSME needing treatment either photocoagulation or ITV.
timeFrame: Months 0, 6, 12 and 24.
Secondary outcomes:
measure: Best corrected visual acuity.
timeFrame: Months 0, 6, 12 and 24.
measure: Vision loss of at least 2 lines documented in ETDRS charts
timeFrame: Months 0, 6, 12 and 24.
measure: Central retinal thickness
timeFrame: Months 0, 6, 12 and 24.
measure: Microaneurysm(MA) activity (number of MA, MA formation and MA disappearance rates and MA turnover)
timeFrame: Months 0, 6, 12 and 24.
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: LV Prasad Eye Institute
state: Andhra Pradesh
city: Coimbra
country: Portugal
facility: AIBILI- Association for Biomedical Research and Inovation on Light and Image.
Study officials:
affiliation: Association for Innovation and Biomedical Research on Light and Image
name: José Cunha-Vaz, MD, PhD
role: STUDY_CHAIR
References:
citation: Cunha-Vaz J, Ribeiro L, Costa M, Simo R. Diabetic Retinopathy Phenotypes of Progression to Macular Edema: Pooled Analysis From Independent Longitudinal Studies of up to 2 Years' Duration. Invest Ophthalmol Vis Sci. 2017 May 1;58(6):BIO206-BIO210. doi: 10.1167/iovs.17-21780.
Clinical trial NCT02517190: Effects of Repeated Short-term Microgravity During Parabolic Flight Conditions on Neuro-endocrine, Immune and Metabolic Changes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: volunteers
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2015-08-06
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: From previous parabolic flight campaigns completed by our research group investigators gathered data showing important changes in neuro-endocrine and also immunological changes. This experiment now will complete the data set-up obtained during the MARS500 study on how these respective individuals will re-act to highly physically and emotionally challenging situations during a parabolic flight.

This add-on experiment to MARS500 will enable answering to the following questions i) if the stress response systems - when compared for two conditions but in the same individuals - do react uniformly and ii) if those subjects prone to have adequate stress response pattern will show gradually less immune modulation effects.

The understanding of the complex interactions of stress and immunity under chronic and acute stress conditions might help to enable adequate health and immune monitoring and might as well suggest suitable countermeasures for the prevention of the unwanted immunological effects during long-term confinement and space missions.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers (men or women)
* Aged from 18 to 65
* Affiliated to a Social Security system and, for non-French resident, holding a European Health Insurance Card (EHIC)
* Who accepted to take part in the study
* Who have given their written stated consent
* Who participated in the MARS500 experiment
* Who has passed a medical examination similar to a standard aviation medical examination for private pilot aptitude. There will be no additional test performed for subject selection.

Exclusion Criteria:

* Person who took part in a previous biomedical research protocol, of which exclusion period is not terminated
* Pregnant women

Primary outcomes:
measure: neuro-endocrine measurements composite
timeFrame: baseline
measure: immunological measurements composite
timeFrame: baseline
measure: cellular energy metabolism measurements composite
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Caen CEDEX
country: France
facility: Umr Ucbn/Inserm U1075 Comete
state: Basse-Normandie
Study officials:
References:
Clinical trial NCT05044390: Lung Transplantation for Pleuroparenchymal Fibroelastosis
Official title: Lung Transplantation for Pleuroparenchymal Fibroelastosis : a French Multicentric Retrospective Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Fibroelastosis
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2021-09-14
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with pleuroparenchymal fibroelastosis who underwent lung transplantation in France between 2005 and 2021.

Brief summary: This retrospective observational study will evaluate the outcomes of lung transplantation for a rare cause of interstitial lung disease called pleuroparenchymal fibroelastosis. Data will be collected from all transplantation center in France.


Eligibility criteria: Inclusion Criteria:

* Lung transplantation (any type) for pleuroparenchymal fibroelastosis
* Histologically confirmed pleuroparenchymal fibroelastosis on the recipient lungs

Exclusion Criteria:

* All other interstitial lung disease than pleuroparenchymal fibroelastosis
* Pleuroparenchymal fibroelastosis who didn't underwent lung transplantation

Primary outcomes:
measure: Post-operative mortality
timeFrame: Any death up to 90 days after lung transplantation
Secondary outcomes:
Other outcomes:
Locations:
city: Le Plessis-Robinson
country: France
facility: Marie Lannelongue Hospital
city: Lyon
country: France
facility: Hopital Louis Pradel
city: Paris
country: France
facility: Bichat Claude Bernard Hospital, APHP
city: Suresnes
country: France
facility: Foch Hospital
Study officials:
References:
Clinical trial NCT05764590: A Study to Evaluate Safety and Efficacy of AP-306 in Hyperphosphatemia Patients
Official title: A Phase 2, Randomized, Open-Label, Active-Controlled, Multicenter Study to Evaluate the Safety and Serum Phosphorus Lowering Effect of AP-306 in Chronic Kidney Disease Patients Receiving Maintenance Hemodialysis With Hyperphosphatemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Kidney Diseases
Hyperphosphatemia
Lead sponsor: Alebund Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2023-03-10
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to learn about the following questions in the patients receiving maintenance hemodialysis with elevated blood phosphorus:

* How much effect AP-306 has assessed by blood phosphorus lowering;
* How safe and tolerable AP-306 is.

Participants will receive either following treatments:

* AP-306, and
* Sevelamer carbonate.


Eligibility criteria: Important Inclusion Criteria:

1. On a stable hemodialysis regimen at a frequency of three times per week for at least 12 weeks prior to the screening visit
2. Dialysis sufficiency SpKt/V ≥ 1.2 at the screening visit or any documented result within 12 weeks prior to the screening visit
3. Serum phosphorus within the trial-required range

Important Exclusion Criteria:

1. Pregnant or breastfeeding
2. Any history of kidney transplant
3. Any history of a parathyroid intervention
4. Any clinically significant GI disorders within 4 weeks prior to the screening visit
5. Hospitalization for cardiac or cerebrovascular disease within 24 weeks prior to the screening visit
6. Hospitalization for cardiac or cerebrovascular disease within 24 weeks prior to the screening visit
7. Documented history of hypersensitivity or allergic reactions to any of the excipients used by AP-306, or history of hypersensitivity or allergic reactions or intolerant to sevelamer carbonate

Primary outcomes:
measure: To evaluate the efficacy of AP-306 assessed by serum phosphorus lowering
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
measure: To evaluate the overall safety of AP-306 assessed by incidence of treatment-emergent adverse events
timeFrame: 15 weeks
Locations:
city: Chengdu
country: China
facility: Sichuan Provincial People's Hospital
state: Sichuan
Study officials:
affiliation: Sichuan Provincial People's Hospital
name: Li Wang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01209390: A Prospective, Post-marketing Registry on the Use of ChondroMimetic for the Repair of Osteochondral Defects
Official title: A Prospective, Open Label, Multi-centre, Post-marketing Registry on the Use of ChondroMimetic for the Repair of Osteochondral Defects
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Osteochondral Defects
Keywords: osteochondral
regenerative
repair
cartilage lesion
Lead sponsor: TiGenix n.v.
Sponsor class: INDUSTRY
First posted: 2010-09-27
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be recruited in selected centres, primary or secondary care, first line or referral treatment.

Brief summary: The objective of this post-marketing study is to confirm the clinical efficacy and safety outcome of treatment with ChondroMimetic in a patient population within the proposed indication (osteochondral cartilage defects), over a 36 months post-implantation follow-up period.

The primary objective is to collect post-marketing safety data in a real life setting by means of (S)ADR reporting.

The secondary objectives are:

* Clinical outcome as assessed by patient reported EuroQoL-5D
* Structural repair as assessed by MRI
* The number of treatment failures and the time to treatment failure
* The ease of use of ChondroMimetic as reported by the surgeon


Eligibility criteria: Inclusion Criteria:

1. Signed patient informed consent
2. Shallow osteochondral defect ≤ 12 mm diameter and ≤ 8 mm depth in weight bearing area
3. Agree to actively participate in a rehabilitation protocol

Exclusion Criteria:

1. Severe vascular or neurological disease
2. Uncontrolled diabetes
3. Severe degenerative joint disease
4. Pregnancy
5. Presence of infection at the site or in the joint space (e.g. osteomyelitis)
6. Diagnosis rheumatoidism
7. Advanced osteoarthritis as judged by the surgeon
8. Drug and/or alcohol abuse
9. Hypercalcemia
10. Known allergy to any of the components of the device (e.g. bovine collagen)
11. Bleeding disorders of any etiology
12. Steroidal or immunosuppressive maintenance therapy

Primary outcomes:
measure: Safety data
timeFrame: on ongoing basis up to 3 years
Secondary outcomes:
measure: EuroQoL-5D
timeFrame: baseline, 6, 12, 24, 36 months
measure: MRI
timeFrame: baseline, 12, 24, 36 months
measure: Failure rate
timeFrame: 3 years
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospitals Leuven
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg
city: Budapest
country: Hungary
facility: Uzsoki Hospital
city: Cambridge
country: United Kingdom
facility: Addenbrookes Hospital
Study officials:
affiliation: Uzsoki Hospital, Budapest, Hungary
name: Laszlo Hangody, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00001990: An Open-Label, Uncontrolled Clinical Trial of Oral 566C80 for the Treatment of Patients With Severe PCP Who Are Intolerant and/or Unresponsive to Therapy With Trimethoprim/Sulfamethoxazole and Parenteral Pentamidine
Official title: An Open-Label, Uncontrolled Clinical Trial of Oral 566C80 for the Treatment of Patients With Severe PCP Who Are Intolerant and/or Unresponsive to Therapy With Trimethoprim/Sulfamethoxazole and Parenteral Pentamidine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pneumonia, Pneumocystis Carinii
HIV Infections
Keywords: Trimethoprim-Sulfamethoxazole Combination
Pneumonia, Pneumocystis carinii
Pentamidine
Antifungal Agents
Acquired Immunodeficiency Syndrome
atovaquone
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: To facilitate provision of atovaquone (566C80) to patients who have severe Pneumocystis carinii pneumonia (PCP) and are intolerant and/or unresponsive to trimethoprim / sulfamethoxazole ( TMX / SMX ); to monitor serious adverse events attributable to 566C80.


Eligibility criteria: Inclusion Criteria

Patients must have the following:

* Clinical diagnosis of acute severe Pneumocystis carinii pneumonia (PCP).
* Dose-limiting intolerance to TMP / SMX and parenteral pentamidine.
* Willingness and ability to give informed consent.

Exclusion Criteria

Co-existing Condition:

Excluded:

* Patients with a history of intolerance to 566C80. Patients with the following prior conditions are excluded: History of serious dose-limiting adverse experience during previous 566C80 therapy, thought to be attributable to the drug.

Required:

* Trimethoprim / sulfamethoxazole (TMP/SMX); pentamidine.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Research Triangle Park
country: United States
facility: Glaxo Wellcome Inc
state: North Carolina
Study officials:
References: