louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00861874: A Study of Decitabine in Combination With Escalating Doses of Rapamycin in Patients With Relapsed or Refractory Acute Myeloid Leukemia
Official title: A Phase I Study of Decitabine in Combination With Escalating Doses of Rapamycin in Patients With Relapsed or Refractory Acute Myeloid Leukemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Acute Myeloid Leukemia
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2009-03-16
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the safety and feasibility of the combination of decitabine given at a fixed dose with escalating doses of rapamycin in patients with relapsed or refractory acute myeloid leukemia.


Eligibility criteria: Inclusion Criteria:

* Age greater than or equal to 18 years
* Diagnosis of AML according to WHO criteria except acute promyelocytic leukemia AND
* Refractory AML defined as a failure to achieve CR after 2 cycles of induction chemotherapy or persistence of \> 40% bone marrow blasts after one cycle of chemotherapy induction OR
* Relapsed AML defined as any evidence of disease recurrence within 12 months of achieving first CR OR
* Relapsed AML after stem cell transplantation 100 days must have elapsed between transplant and emergence of recurrent AML
* ECOG performance status \<3 (Appendix 1)

Exclusion Criteria:

* Abnormal renal function as evidenced by a calculated creatinine clearance ≤ 30ml/min (Cockcroft-Gault formula (Appendix 2)
* Abnormal liver function: Bilirubin \>2.0 mg/dl, transaminase more than 2.5x the upper limits of normal
* Active systemic infection
* Known chronic liver disease
* Known diagnosis of human immunodeficiency virus infection (HIV)
* Patients who are post-allogeneic transplantation should not have active GVHD greater than grade 1 of skin
* Pregnant or breast feeding female subjects

Primary outcomes:
measure: Evaluate the safety of chemotherapy with the drug decitabine combined with rapamycin to determine the highest dose of rapamycin that can be given in combination with decitabine.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
affiliation: University of Rochester
name: Jane Liesveld, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Liesveld JL, O'Dwyer K, Walker A, Becker MW, Ifthikharuddin JJ, Mulford D, Chen R, Bechelli J, Rosell K, Minhajuddin M, Jordan CT, Phillips GL 2nd. A phase I study of decitabine and rapamycin in relapsed/refractory AML. Leuk Res. 2013 Dec;37(12):1622-7. doi: 10.1016/j.leukres.2013.09.002. Epub 2013 Sep 8.
Clinical trial NCT06007274: Troponin to Detect Major Cardiovasculaire Advserse Events on Immune Checkpoint Inhibitors
Official title: Troponin to Detect Major Cardiovasculaire Advserse Events on Immune: a Case Control Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Immune Checkpoint Inhibitor
Cardiovascular Biomarkers
Lead sponsor: Institut Mutualiste Montsouris
Sponsor class: OTHER
Collaborators: name: Institut Curie
First posted: 2023-08-23
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adult solid cancer patients receiving immune checkpoint inhibitors

Brief summary: Recent guidelines suggest the use of troponin to detect immnune related cardiovascular advserse events in patients treated by immune checkpoint inhibitors for cancer.

However, there is no proof that patients on immune checkpoint inhibitors benefit from this active surveillance strategy. The suspicion of cardiovascular events may lead to the interruption of cancer therapies.

The TILT study aims at assessing: (i) the efficiency of troponin measurments in asymptomatic patients to prevent the further advent of major cardiovascular events; (ii) its safety in terms of cancer therapy completion.

Detailed description: Retrospective two-center study comparing two groups of patients on immune checkpoint inhibitors:

* Group 1: active surveillance by serial troponin measures not prompted by cardiovascular symptoms ;
* Group 2: no troponin measures.

For any solid cancer or stage.

Eligibility criteria: Inclusion Criteria:

* All solid cancer patients treated by immune checkpoint inhibitors 2017-2022

Exclusion Criteria:

* Patients enrolled in an invterventional study (e.g., pharma trial)

Primary outcomes:
measure: Major cardiovascular event
timeFrame: 5 years
Secondary outcomes:
measure: Completion of cancer therapy as scheduled
timeFrame: 5 years
Other outcomes:
Locations:
city: Paris
country: France
facility: Institut Mutualiste Montsouris
Study officials:
affiliation: Institut Mutualiste Montsouris
name: Mariana Mirabel, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02737774: Alternating Icotinib and Chemotherapy for Advanced Non-small Cell Lung Cancer With EGFR Mutation
Official title: A Single Armed Phase ⅡStudy of Alternating Icotinib and Chemotherapy for Advanced Non-small Cell Lung Cancer With EGFR Mutation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Lung Adenocarcinoma
Keywords: Icotinib
chemotherapy
EGFR
Lead sponsor: Henan Cancer Hospital
Sponsor class: OTHER_GOV
First posted: 2016-04-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a prospective, open, single-center, phase Ⅱ study to assess the efficacy and safety of alternating Icotinib and chemotherapy for advanced non-small cell lung cancer with EGFR mutation.


Eligibility criteria: Inclusion Criteria:

1. Histological or cytological confirmation of non-small cell lung cancer (NSCLC) in phase ⅢB or phase Ⅳ.
2. Positive EGFR mutation(19 exon or 21 exon)。

Exclusion Criteria:

1. Previous usage of EGFR-TKI or antibody to EGFR: gefitinib, erlotinib, herceptin, erbitux.
2. Severe systemic disease out of control such as unstable or uncompensated respiratory,cardiac,liver,renal diseases.
3. Allergic to icotinib
4. metastases of spinal cord, meninges or meningeal.

Primary outcomes:
measure: Progression Free Survival
timeFrame: from the day confirmed NSCLC to the day of first detecting progression, up to 24 months
Secondary outcomes:
measure: overall survival time
timeFrame: from the day confirmed NSCLC to the day of death, up to 36 months
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Henan cancer hospital
state: Henan
Study officials:
affiliation: Henan Cancer Hospital
name: Qiming Wang, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sun X, Zheng Y. Retreatment with icotinib in a patient with metastatic lung adenocarcinoma. Tumori. 2013 May-Jun;99(3):e124-6. doi: 10.1177/030089161309900331.
citation: Zheng Y, Fang W, Deng J, Zhao P, Xu N, Zhou J. Sequential treatment of icotinib after first-line pemetrexed in advanced lung adenocarcinoma with unknown EGFR gene status. J Thorac Dis. 2014 Jul;6(7):958-64. doi: 10.3978/j.issn.2072-1439.2014.07.18.
citation: Wang DS, Patel A, Shukla S, Zhang YK, Wang YJ, Kathawala RJ, Robey RW, Zhang L, Yang DH, Talele TT, Bates SE, Ambudkar SV, Xu RH, Chen ZS. Icotinib antagonizes ABCG2-mediated multidrug resistance, but not the pemetrexed resistance mediated by thymidylate synthase and ABCG2. Oncotarget. 2014 Jun 30;5(12):4529-42. doi: 10.18632/oncotarget.2102.
Clinical trial NCT00445874: Evaluation of Efficacy and Safety of an Anti-Allergy Drug With a Contact Lens in the Treatment of Allergic Conjunctivitis
Official title: A Multi-Center, Randomized, Double-Masked, Placebo-Controlled Evaluation of the Efficacy and Safety of an Anti-Allergy Drug With a Contact Lens as Compared to Placebo in the Prevention of Allergic Conjunctivitis in a Population of Allergic Contact Lens Wearers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Allergic Conjunctivitis
Keywords: allergic conjunctivitis, ophthalmology, multicenter, controlled
Lead sponsor: Vistakon Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2007-03-09
Enrollment: 120
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to evaluate the efficacy and safety of an anti-allergy drug with a contact lens compared to placebo in preventing ocular itching associated with allergic conjunctivitis


Eligibility criteria: Inclusion Criteria:

* History of ocular allergies and a positive skin test reaction to cat hair, cat dander, grasses, ragweed, and/or trees withing the past 24 months
* Successful soft contact lens wearer who has frequently worn contact lenses for at least one month or more

Exclusion Criteria:

* Active ocular infection
* Clinically significant blepharitis
* Follicular conjunctivitis
* Pterygium
* Narrow angle glaucoma
* Dry eye dyndrome
* Ocular surgery within past 6 months
* Pregnancy or lactation

Primary outcomes:
measure: Ocular itching
Secondary outcomes:
measure: Conjunctival, ciliary, and episcieral redness; chemosis and mucous discharge; tearing and lid swelling
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
city: Phoenix
country: United States
state: Arizona
city: Irvine
country: United States
state: California
city: North Andover
country: United States
state: Massachusetts
city: Cincinnati
country: United States
state: Ohio
city: Fairfield
country: United States
state: Ohio
city: Mason
country: United States
state: Ohio
Study officials:
affiliation: Vistakon Pharmaceutical
name: Brian Pall, OD, MS, FAAO
role: STUDY_DIRECTOR
References:
Clinical trial NCT06550674: Identification of New Candidate Genes for Hereditary Predisposition to Uveal Melanoma
Official title: Identification of New Candidate Genes for Hereditary Predisposition to Uveal Melanoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Uveal Melanoma
Keywords: uveal melanoma
hereditary predisposition
candidate genes identification
Lead sponsor: Centre Jean Perrin
Sponsor class: OTHER
Collaborators: name: Association Nationale des Patients atteints de cancers de l'oeil (A.N.P.A.C.O.)
First posted: 2024-08-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Only 20% of familial uveal melanomas are explained by a hereditary predisposition, implying the presence of as yet unknown hereditary predispositions. This hypothesis is reinforced by epidemiological studies revealing an excess risk of prostate cancer, thyroid cancer and leukemia in patients who have developed uveal melanoma, even though these cancers are not part of the tumor spectrum of known hereditary predispositions to uveal melanoma (BAP1, MBD4). The identification of new candidate genes, once validated, would enable us to offer these families appropriate surveillance.


Eligibility criteria: Inclusion Criteria:

* Patient with a personal history of uveal melanoma (newly diagnosed, under treatment or in follow-up)
* Enrolled in or benefiting from a social security scheme

Exclusion Criteria:

* Causal pathogenic variation identified in BAP1 or MBD4
* Patient does not consent to constitutional genetic analysis for diagnostic purposes
* Patient not consenting to a constitutional genetic analysis for research purposes
* Pregnant and breast-feeding women
* Patients under guardianship or trusteeship

Primary outcomes:
measure: Identify new candidate genes for hereditary cancer predisposition in patients with uveal melanoma by constitutional exome analysis
timeFrame: At baseline
Secondary outcomes:
measure: Explore genes known to be involved in other cancer predisposition already described in the occurrence of uveal melanoma, but whose association has not yet been established with certainty.
timeFrame: At baseline
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Centre Jean PERRIN
state: Puy-de-Dôme
Study officials:
affiliation: Centre Jean Perrin
name: Mathis LEPAGE, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06636474: Evaluation of the Supported Housing System for the Inclusion of People Suffering From Mental Disorders
Official title: Evaluation of the Supported Housing System for the Inclusion of People Suffering From Mental Disorders
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mental Disorder
Lead sponsor: Centre Hospitalier St Anne
Sponsor class: OTHER
First posted: 2024-10-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All patients benefiting from a DLAI and suffering from psychiatric disorders, monitored in sector 75G08-09 of the Saint-Maurice hospitals, and sectors 75G19, 75G20-21, 75G25, 75G26 of the GHU Paris.
Primary purpose: OTHER

Brief summary: Access to housing, in the current context of extreme tension in the rental housing market in Paris and throughout the Ile-de-France region, is proving to be extremely complex for people with mental health problems.National and international scientific studies have quantified the problem of homelessness and precarious or inappropriate housing among patients suffering from psychiatric disorders, and show the impact of housing problems on the consumption of psychiatric care.The DÉLAI's mission is to facilitate access to housing for people enrolled in a psychiatric care pathway, with teams from the psychiatric sectors

Detailed description: * Written and oral information provided to the patient by the patient's referring psychiatrist (Investigator of one of the five recruiting sites) during a regular consultation appointment.
* Initial assessment (V inclusion): reminder of the information concerning the research, collection of consent, collection of sociodemographic data, and standardized assessment scales (quality of life, clinical state, level of functioning) + standardized semi-structured interview for the diagnosis of psychiatric disorders + completion by the referring psychiatrist of the data corresponding to the patient's care pathway.
* Then follow-up visit at an annual rate (V1 ... VX), and DLAI exit assessment (V exit) as soon as the patient stops benefiting from the DLAI.

Eligibility criteria: Inclusion Criteria:

patient followed for a psychiatric disorder patient benefiting from a DLAI

Exclusion Criteria:

patient not followed for psychiatric disorder patient who refused to participate in the research

Primary outcomes:
measure: improvement of quality of life
timeFrame: one year
measure: improvement of quality of life
timeFrame: one year
Secondary outcomes:
measure: clinical condition
timeFrame: one year
Other outcomes:
Locations:
city: Paris
country: France
facility: Centre Hospitalier Sainte Anne
Study officials:
References:
Clinical trial NCT03552874: Pulmonary and Upper Limb Functions in Duchenne Muscular Dystrophy
Official title: The Comparison of Pulmonary and Upper Extremity Functions Between Children With Duchenne Muscular Dystrophy and Healthy Peers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Duchenne Muscular Dystrophy
Upper Limb Function
Respiratory Function Test
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2018-06-12
Enrollment: 47
Sex: MALE
Minimum age (years): 5
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Fourty seven participants including 31 children with DMD and 16 healthy peers were included

Brief summary: Although it is known that the functions of pulmonary and upper limb is affected in late stage of Duchenne Muscular Dystrophy (DMD) negatively, the investigators do not have clear information about its early stage. The aim of this study was to investigate the differences in pulmonary and upper limb functions between children with DMD in early stage and healthy peers.


Eligibility criteria: Inclusion Criteria:

children with DMD was;

* age between 5-10 years
* being on treatment with corticosteroids for more than 6 months
* being at Level I according to Brooke Upper and Lower Extremity Classification Systems

Healthy peers;

* age between 5-10 years
* not having any diagnosed disease

Exclusion Criteria:

• Children has undergo surgery and disease affect upper extremity or pulmonary function in last six months.

Primary outcomes:
measure: Pulmonary Function Test (PFT)
timeFrame: 5 minutes
measure: The Performance Upper Limb (PUL)
timeFrame: 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02943174: MIND Programme for Cancer Patients
Official title: MIND Programme for Cancer Patients: A Group Intervention Programme Based on Third Wave Psychotherapies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Lead sponsor: University of Coimbra
Sponsor class: OTHER
First posted: 2016-10-24
Enrollment: 32
Sex: FEMALE
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: This investigation aims to apply and test the acceptability of an acceptance, mindfulness and compassionate-based intervention structured for cancer patients. MIND programme for cancer thus comprises 8 weekly group sessions, lasting 1 and a half hour each, run in small groups at an Oncology Service at the Coimbra's University Hospital. For each week participants have assigned homework (e.g., mindfulness exercises). This programme mainly aims to increase participants' physical and psychosocial quality of life, and attenuate depressed mood and anxiety.

Detailed description: The sample will include diagnosed cancer patients recruited at an Oncology Service at the Coimbra's University Hospital. Patients will be approached by their doctor to assess their level of interest in the investigation. Patients who demonstrate interest will go through a Screening interview conducted by a licensed psychologist that aims explain the structure and arms of the investigation, to collect demographic data, and whether the patient meets the inclusion criteria for the study. Patients who meet the inclusion criteria and demonstrate interest in participating in the study, will sign an informed consent. All ethical requirements for research with humans are guaranteed.

Afterwards, participants will be allocated in two groups (experimental and control group). Both groups will maintain the medical treatment as usual (TAU). Additionally, the experimental group will enroll in the MIND programme for cancer patients, also provided by a licensed psychologist.

Both groups will concurrently complete a protocol of self-report measures and their medical data will be collected by the medical staff of the Hospital.

Eligibility criteria: Inclusion Criteria:

* diagnosis of breast cancer (stages I-III)

Exclusion Criteria:

* severe psychopathology
* difficulty in completing self-report measures

Primary outcomes:
measure: Changes in psychopathology (namely, depression and anxiety symptoms)
timeFrame: From Baseline to follow-up
measure: Changes in Quality of Life
timeFrame: From Baseline to follow-up
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01169974: Use of Laser Speckle to Study Post Occlusive Reactive Hyperhemia in Healthy Subjects
Official title: Evaluation Chez Des Sujets Volontaires Sains de l'ischémie-reperfusion cutanée
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Microcirculation
Keywords: Microcirculation
laser flowmetry
Skin
Physiology
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2010-07-26
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: healthy volunteers

Brief summary: The investigators aim to test the hypothesis that Laser speckle contrast imaging allows for the measurement of cutaneous blood flow following various durations of tourniquet ischemia.

Detailed description: Ischemia and post occlusive reactive hyperemia in the skin is tested in healthy normal subjects for tourniquet ischemias of 1, 2 \& 3 minutes at rest.

Eligibility criteria: Inclusion Criteria:

* Healthy volunteers
* Affiliation to the French health system

Exclusion Criteria:

* Any disease or chronic treatment

Primary outcomes:
measure: Laser speckle
timeFrame: with 2 minutes of ischemia
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: University hospital
Study officials:
affiliation: University Hospital in Angers
name: Guillaume Mahe
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04373174: The Effect of Regional Anesthesia Techniques on Brain Tissue Oxygenation in Thoracic Surgery
Official title: The Effect of Regional Anesthesia Techniques on Brain Tissue Oxygenation in Thoracic Surgery Operations Where Single Lung Ventilation is Applied
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thoracic Surgery
Epidural Anesthesia
Cerebral Oxygen Saturation
Lead sponsor: Bursa Yüksek İhtisas Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2020-05-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective,randomized
Primary purpose: PREVENTION

Brief summary: Today, it is preferred that the lung with pathology for thorax surgery is not under ventilation during operation in terms of reliability and ease of operation.

For this reason, the anesthesia approach is characteristic and it is ensured that the single lung is not ventilated during the operation by means of specially manufactured intubation tubes. This application can disrupt tissue oxygenation due to both Operation position and single lung ventilation.

Thoracic epidural analgesia, which is applied as the gold standard of Thoracic Surgery, is applied prior to the operation and is provided to assist in postoperative analgesia.

Detailed description: The aim of this study was to investigate the effect of thoracic epidural analgesia method on brain tissue oxygenation in patients with single lung ventilation.

Eligibility criteria: Inclusion Criteria:

* Patients who were in the American Society of Anesthesiologists (ASA) I-III class
* Underwent Thoracic Surgery

Exclusion Criteria:

* Local anesthetic allergy,
* Bleeding is a diathesis disorder
* Allergic to the drugs used,
* Patients who are not reluctant to participate in the study,
* Presence of infection in the block area,
* Patients whose body mass index is over 30

Primary outcomes:
measure: rso2
timeFrame: peroperative 2 hours
Secondary outcomes:
measure: po2
timeFrame: peroperative 2 hours
measure: ETCO2
timeFrame: peroperative 2 hours
Other outcomes:
Locations:
city: Bursa
country: Turkey
facility: Bursa Yuksek Ihtisas Training and Research Hospital
Study officials:
affiliation: Sağlık Bilimleri Üniversitesi Bursa Yüksek İhtisas Eğitim Ve Araştırma Hastanesi
name: Korgün Ökmen, Assoc. PhD.
role: STUDY_DIRECTOR
References: