louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04762862: QUANTACT : Impact of Pangenomic QUANTitative Alterations in Cancer Therapy
Official title: QUANTACT : Impact of Pangenomic QUANTitative Alterations in Cancer Therapy
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Solid Tumor
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
Collaborators: name: Centre Antoine Lacassagne
First posted: 2021-02-21
Enrollment: 1200
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: Cancer patients for which no standard or curative treatment was available and for which the personalized management was discussed in a Molecular Tumor Board.

Brief summary: "Precision medicine and targeted therapies have played a crucial role over the past ten years in the personalized care of cancer patients. In this retrospective and observational study, we focused on patients for which no standard or curative treatment was available and for which the management was discussed in a Molecular Tumor Board (MTB).

The role of the MTB is to decide the most appropriate therapeutic options for patients according to the potential identification of molecular targets.

Among the analyses carried out, we focused on a quantitative genome-wide analysis: the CGH/SNP-array (Comparative Genomic Hybridization / Single Nucleotide Polymorphism on array). The objective was to evaluate the impact of CGH/SNP-array analyses in the identification of targeted molecular alterations.

"


Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically confirmed solid tumor malignancy that is advanced or metastatic ;
* no standard or curative treatment available;
* non-opposition of the patient collected.

Exclusion Criteria:

* multiple cancer patient;
* ECOG Scale of Performance Status (PS) ≥2

Primary outcomes:
measure: Number of targeted molecular alterations
timeFrame: at day 0
Secondary outcomes:
measure: Number of patients eligible for targeted therapy (clinical trials or "off-label" drug)
timeFrame: at day 0
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de Nice
Study officials:
References:
Clinical trial NCT00069862: Iron Balance Study of DFO and GT56-252 in Patients With Transfusional Iron Overload Secondary to Beta-Thalassemia
Official title: Iron Balance Study of DFO and GT56-252 in Patients With Transfusional Iron Overload Secondary to Beta-Thalassemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Beta-Thalassemia
Keywords: Beta Thalassemia
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2003-10-03
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A clinical trial designed to compare the safety and iron excretion properties of desferoxamine (DFO) and deferitrin (GT56-252), an experimental oral iron chelator.


Eligibility criteria: Inclusion Criteria:

* Beta-thalassemia patients, 18 years of age or older, currently undergoing chronic blood transfusion therapy and iron chelation therapy who weigh more than 40 kg.
* No clinically significant findings on physical exam, medical history, or screening laboratories.
* Serum ferritin greater than 500 ng/mL, serum creatine creatinine within the normal range and platelet count greater than 100,000/mm3.
* Willing and able to discontinue DFO or L1 for the period of study.
* Woman of child-bearing potential must have a negative serum pregnancy test at screening and use a medically acceptable form of birth control during the study and for 1 month afterward. Male patients must also use barrier contraceptives during the study and for 1 month afterward.
* Have a level of understanding and willingness to cooperate with the confinement and all procedures. Able to provide voluntary signed/dated written informed consent.

Exclusion Criteria:

* Serious medical condition unrelated to Beta-Thalassemia.
* Participation in a previous investigational drug study within 30 days preceding screening.
* Patients with a known allergy to DFO that prevents chronic administration.

Primary outcomes:
measure: safety and tolerability
measure: iron excretion in urine and stool
measure: pharmacokinetic measurements
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: The New York Presbyterian Hospital-Weill Medical College of Cornell University
state: New York
Study officials:
References:
Clinical trial NCT02382562: Brief Behavioral Activation Intervention for Depressed Asthma and Urticaria Patients
Official title: Brief Behavioral Activation Intervention for Depressed Asthma and Urticaria Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Depression
Asthma
Urticaria
Keywords: Depression
Asthma
Urticaria
Lead sponsor: University of Mississippi Medical Center
Sponsor class: OTHER
First posted: 2015-03-06
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Depression and other unhealthy behaviors, such as not taking medication as prescribed and not attending doctor visits have been suggested to increase the worsening of allergic diseases (e.g. asthma, urticaria). We intend to determine whether a one-session behavioral intervention is effective in helping with depression and controlling disease symptoms. We will measure this using pre- and post-intervention surveys.

Detailed description: The purpose of this research study is to investigate whether a one-session behavioral activation intervention for depression can successfully reduce depression and improve asthma or urticaria disease-relevant outcomes (medication adherence, doctor's visits, substance abuse) in clinical patients with asthma or urticaria who report heightened levels of depression and are seen in the UMMC Allergy Clinic.

Eligibility criteria: Inclusion Criteria:

* Potential participants should be between the ages 18 and 64, seen in the UMMC Allergy Clinic with either asthma or urticaria and who report symptoms of depression in the previous 2 weeks.

Exclusion Criteria:

* Potential participants younger than 18 and older than 64 or who do not speak English or cannot comprehend the consent form or women who are pregnant are excluded.

Primary outcomes:
measure: Asthma Control Test
timeFrame: 4 weeks
measure: Urticaria Control Test
timeFrame: 4 weeks
Secondary outcomes:
measure: Asthma Quality of Life Questionnaire
timeFrame: 4 weeks
measure: Urticaria Activity Score Questionnaire
timeFrame: 4 weeks
measure: Psychological Measures (Composite)
timeFrame: 4 weeks
Other outcomes:
measure: Immune biomarkers
timeFrame: 4 weeks
Locations:
city: Jackson
country: United States
facility: University of Mississippi Medical Center - Allergy, Immunology and Asthma Care Clinic
state: Mississippi
Study officials:
affiliation: University of Mississippi Medical Center
name: Gailen D Marshall, Jr., MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01386762: Effect of Intense Multi-modal Training on Bone Health and Quality of Life in Persons With Spinal Cord Injury
Official title: Effect of Intense Multi-modal Training on Bone Health and Quality of Life in Persons With Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Spinal Cord Injury
Obesity
Keywords: paralysis
paraplegia
obesity
Lead sponsor: California State University, San Marcos
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2011-07-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Bone loss is a common secondary complication of spinal cord injury (SCI), and treatments used to reverse this condition have equivocal effectiveness. The aim of this study is to determine the effect of intense multi-modal training on bone health, body fat, and quality of life in persons with SCI. Participants will complete 6 months of training during which various measures will be obtained at 0, 3, and 6 months. Control subjects are also being recruited to complete testing but not participate in training.


Eligibility criteria: Inclusion Criteria:

* Stable spinal cord injury below C2
* doctor's permission to participate in the study
* non-pregnant

Exclusion Criteria:

* see above

Primary outcomes:
measure: Bone mineral density
timeFrame: 6 months
Secondary outcomes:
measure: Body fat
timeFrame: 6 months
Other outcomes:
Locations:
city: San Marcos
country: United States
facility: CSU--San Marcos Human Performance Lab
state: California
Study officials:
References:
Clinical trial NCT06136962: Nasopharyngeal Carcinoma Treated With Reduced Volume Intensity Modulated Radiation Therapy:10-Year Outcome and Late Toxicity, Quality of Life
Official title: A Comprehensive Prospective Study on the 10-Year Outcome and Late Toxicity, Quality of Life of Reduced Volume Intensity Modulated Radiation Therapy in Nasopharyngeal Carcinoma
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Nasopharyngeal Carcinoma
Lead sponsor: Fujian Cancer Hospital
Sponsor class: OTHER_GOV
First posted: 2023-11-18
Enrollment: 500
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: Histologically diagnosed non-metastatic Nasopharyngeal carcinoma (NPC) patients who were treated with Reduced Volume Intensity Modulated Radiation Therapy.

Brief summary: Nasopharyngeal carcinoma (NPC) is a type of head and neck cancer. The last three decades of research in head and neck radiation oncology have largely focused on improvements in survival, which have mostly come at the cost of long term toxicity for surviving patients.This is an observational study that is being done to evaluate the long-term efficacy, learn about the toxicity and quality of life that survivors of nasopharyngeal carcinoma may have following treated with reduced volume intensity modulated radiation therapy.


Eligibility criteria: Inclusion Criteria:

* Received treatment with Reduced Volume Intensity Modulated Radiation Therapy
* Age 18 or above, upper limit 65
* Ability to comply with the protocol

Exclusion Criteria:

* History of recurrent nasopharyngeal disease
* A history of any physical, psychological or social condition which would impair with the ability of the patient to cooperate in this study
* Unable to provide consent

Primary outcomes:
measure: Overall survival
timeFrame: 10 years
Secondary outcomes:
measure: Loco-regional failure-free survival
timeFrame: 10 years
measure: Failure-free survival
timeFrame: 10 years
measure: Distant failure-free survival
timeFrame: 10 years
measure: Quality of Life Questionnaires QLQ-C30
timeFrame: 1year
measure: Quality of Life Questionnaires
timeFrame: 1year
measure: Evaluation of late toxicities
timeFrame: 1year
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Department of radiation oncology, Fujian cancer hospital
state: Fujian
Study officials:
References:
Clinical trial NCT03535662: A Pharmacokinetic Study of the Effect of Itraconazole Exposure to Orvepitant in Healthy Volunteers
Official title: A Phase 1, Open-Label, Single-Sequence Crossover Study in Healthy Male Participants to Determine the Effect of an Inhibitor of Cytochrome P450 3A and P Glycoprotein on Exposure to Orvepitant
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pharmacokinetic Study in Healthy Male Volunteers
Lead sponsor: Nerre Therapeutics Ltd.
Sponsor class: INDUSTRY
First posted: 2018-05-24
Enrollment: 16
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: A Phase 1 study to assess the effect of itraconazole, a strong inhibitor of CYP3A and P-glycoprotein, on the pharmacokinetics (PK) of orvepitant in healthy male volunteers.

Subjects will receive two single doses of 20mg orvepitant, once alone and once in combination with repeat doses of itraconazole. All subjects will follow the same sequence - orvepitant alone followed by orvepitant in combination with itraconazole.


Eligibility criteria: Key Inclusion Criteria:

* male volunteers
* judged to be in good health, based on the results of medical history, physical examination, vital signs, 12 lead ECG, and clinical laboratory findings
* body weight greater than 50 kg and body mass index (BMI) within the range 18 to 30 kg/m2 (inclusive)

Key Exclusion Criteria:

* clinically significant findings on physical examination
* relevant medical history
* history of or considered at high risk of seizures (except febrile fits in childhood), including history of significant head injury
* positive serology for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (anti-HCV) or human immunodeficiency virus (HIV)
* serum biochemistry and full blood count considered by the Investigator to be of clinical significance
* systolic blood pressure \<100 or \>140 mmHg or diastolic BP \<50 or ˃90 mmHg, measured prior to the first dose of orvepitant
* abnormal 12 lead electrocardiogram (ECG)
* has donated one or more units (approximately 450 mL) of blood or acute loss of an equivalent amount of blood within 90 days prior to study intervention administration

Primary outcomes:
measure: Exposure to orvepitant
timeFrame: 0 to 168 hours post dose
Secondary outcomes:
Other outcomes:
Locations:
city: Harrow
country: United Kingdom
facility: Parexel Epcu
state: Middlesex
Study officials:
affiliation: PAREXEL EPCU
name: Principal Investigator
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06357962: Semi-permanent Acupuncture Effect on Cervical Ripening
Official title: Clinical Trial with Two Branches to Study the Effect of Semi-permanent Acupuncture At Specific Acupuncture Points on Reducing the Number of Inductions During Labor in Women At Low or Moderate Risk
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pregnancy Complications
Keywords: Cervical Ripening
Acupuncture Therapy
Lead sponsor: Consorci Sanitari de l'Alt Penedès i Garraf
Sponsor class: OTHER
First posted: 2024-04-10
Enrollment: 30
Sex: FEMALE
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Cervical ripening is a medical treatment that can cause physical or emotional discomfort in pregnant women and is not without risks. This is a pilot study to assess feasibility and calculate the number of participants necessary for a complete clinical trial. The aim is to evaluate whether acupuncture can reduce the need for treatment (cervical ripening) in pregnant women at low or intermediate risk. Participants will be divided into two groups: one group will receive acupuncture, and the other will receive a simulated treatment of acupuncture.


Eligibility criteria: Inclusion Criteria:

* Anticipated delivery at the study center.
* Ability to collaborate in necessary evaluations.
* Legal capacity to provide informed consent.
* Signature of the informed consent for inclusion in the study, by oneself.

Exclusion Criteria:

* Pregnancy with high or very high risk as described by the Pregnancy and Childbirth Monitoring Protocols of the Department of Health of Catalonia
* History of cesarean delivery.
* Language barrier preventing collaboration in study procedures.
* Cognitive or affective pathology limiting the ability to collaborate with study procedures.
* Participation in another clinical trial involving an experimental intervention during the period of this trial and/or establishing a visit frequency incompatible with this trial.

Primary outcomes:
measure: Pharmacological induction
timeFrame: Birth date
Secondary outcomes:
measure: Change on score of Bishop scale
timeFrame: Birth date
measure: Onset of spontaneous labor
timeFrame: Birth date
measure: Duration of induction period Duration of the induction period Duration of the induction period Duration of the induction period
timeFrame: Birth date
measure: Duration of labor period
timeFrame: Birth date
measure: Satisfaction of pregnants
timeFrame: Birth date
Other outcomes:
Locations:
city: Vilafranca Del Penedès
country: Spain
facility: Consorci Sanitari Alt Penedes i Garraf
state: Barcelona
Study officials:
affiliation: CSAPG
name: Gloria Villena
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04215562: Outcome of Facial Palsy Following Rehabilitation
Official title: Outcome and Complications of Peripheral Facial Palsy Following Rehabilitation: A Retrospective Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Facial Paralysis
Lead sponsor: University of Alexandria
Sponsor class: OTHER
First posted: 2020-01-02
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Retrospective case series,the aim of this study is to assess the outcome and rate of complications in patients with facial palsy following rehabilitation, a retrospective study.

Detailed description: Data from all patients presenting to the outpatient clinics of the Physical Medicine, Rheumatology and Rehabilitation Department. Faculty of Medicine, Alexandria University in the past 3 years will be collected. The outcome and complications from rehabilitation of facial palsy will be recorded.

Primary Outcome: complications of Facial palsy following rehabilitation. Confidentiality of all records will be ensured.

Eligibility criteria: Inclusion Criteria:

* all patients with primary idiopathic peripheral facial palsy

Exclusion Criteria:

* all patients with secondary causes of facial palsy

Primary outcomes:
measure: prognosis or outcome of therapy
timeFrame: 3-6 months
measure: complications
timeFrame: 3-6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria University, Faculty of Medicine
Study officials:
affiliation: Alexandria University Faculty of Medicine
name: Yousra Hisham A Fattah
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01726062: Motivational Incentives to Reduce Secondhand Smoke in NICU Infants' Homes
Official title: Motivational Incentives to Reduce Secondhand Smoke in NICU Infants' Homes (The Baby's Breath II Project)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Exposure to Secondhand Smoke in Neonatal Infants
Keywords: Motivational Incentives
Motivational Interviewing
Secondhand Smoke
Neonatal Intensive Care Unit
NICU
High respiratory risk infants
Low birth weight infants
Environmental Tobacco Smoke
Smoking
Contingency management
Infants
Children
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: Memorial Hermann Hospital
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2012-11-14
Enrollment: 360
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: A randomized, controlled, parallel group design will be used to test whether a Secondhand Smoke Exposure program initiated in the hospital and completed in the home using motivational interviewing plus motivational incentives (MI+) is more effective than Conventional Care (CC) with Neonatal Incentives Care Unit Infants' parents.


Eligibility criteria: Inclusion Criteria:

* Have an infant that is at least 1 week prior to the estimated date of hospital discharge in the NICU at Children's Memorial Hermann Hospital (CMHH)
* Report at least one person living in the home who smokes
* Agree to attend intervention sessions and to invite other household members
* Live within 50 miles of our center
* Have access to a telephone.

Exclusion Criteria:

* Severe cognitive, and/or psychiatric impairment, per judgment of NICU and research staff, that precludes cooperation with study protocol
* Inability to read, write, and speak English or Spanish
* Inability or unwillingness to provide signed consent for participation
* Inability or unwillingness to meet study requirements, including home visits for data collection and intervention purposes.

Primary outcomes:
measure: Infant Second-Hand Smoke Exposure via Urine Cotinine
timeFrame: Follow-up visit 4 months post-treatment
Secondary outcomes:
measure: Secondhand Smoke Exposure outcomes
timeFrame: Change from Baseline to the 4 months post-treatment followup
Other outcomes:
Locations:
city: Houston
country: United States
facility: Children's Memorial Hermann Hospital
state: Texas
Study officials:
affiliation: University of Texas at Houston Family and Community Medicine
name: Angela Stotts, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stotts AL, Northrup TF, Green C, Suchting R, Hovell MF, Khan A, Villarreal YR, Schmitz JM, Velasquez MM, Hammond SK, Hoh E, Tyson J. Reducing Tobacco Smoke Exposure in High-Risk Infants: A Randomized, Controlled Trial. J Pediatr. 2020 Mar;218:35-41.e1. doi: 10.1016/j.jpeds.2019.10.070. Epub 2019 Dec 20.