louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03234985: Study of Intracellular Nucleotide Pools Determination as Biomarker of the Efficacy of the Induction Treatment in Acute Myeloid Leukemia
Official title: Study of Intracellular Nucleotide Pools Determination as Biomarker of the Efficacy of the Induction Treatment in Acute Myeloid Leukemia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Myeloid Leukemia
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2017-08-01
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients or healthy volunteers over 18 years with acute myeloid leukemia (except acute myeloid leukemia3)

Brief summary: Treatment of acute myeloid leukemia (AML) consists in two main phases: induction and consolidation. Standard chemotherapy combination for induction treatment associates cytarabine (AraC), a nucleoside analog, and an anthracycline (most often daunorubucin). About 60-70% of patients achieved complete remission after this standard chemotherapy. As cytarabine competes with endogenous nucleotides to exert its activity, the aim of this protocol is to study in vivo the effect of intracellular nucleotide pools on the efficacy of the induction treatment. Thus, intracellular nucleotides levels will be determined in peripheral blood mononuclear cells of patients with acute myeloid leukemia before treatment, and results will be compared with the efficacy of the treatment. This parameter will be assessed by the achievement of complete remission.


Eligibility criteria: Patients Inclusion Criteria:

* age over 18 years
* acute myeloid leukemia
* standard induction chemotherapy with cytarabine and daunorubicin
* patients who received the information and did not object to participate to the study

Patients Exclusion Criteria:

- patients with acute myeloid leukemia 3

healthy volunteers Inclusion Criteria :

* adults without known hematological disease,
* adults who received the information and did not object to participate in the study

healthy volunteers Exclusion Criteria :

- Volunteers with known hematological disease.

Primary outcomes:
measure: Complete remission
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Pierre-Bénite
country: France
facility: Service d'hématologie - Centre Hospitalier Lyon Sud - Hospices Civils de LYON
Study officials:
References:
Clinical trial NCT03637985: Effect of 12 Weeks of Resistive Exercises Versus Aerobic Exercises in Overweight Hypertensive Postmenopausal Women
Official title: Exercise and Menopausal Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Exercise
Keywords: resistive exercises
aerobic
Menopause
hypertension
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-08-20
Enrollment: 60
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Sixty postmenopausal women participated in this study from gynecological outpatient clinic, at Al-Zahra universal Hospital, Al Azhar University, and Cairo. They were first diagnosed to be hypertensive in their early postmenopausal period .Their blood pressure ranged between 140/90mmHg to 170/105mmHg, their ages ranged from 50 to 60 years and their body mass index ranged from 30:35 kg/m2.

Detailed description: The participants were divided randomly according to closed envelop into three equal groups in number: Group A (RE) consisted of twenty women who participated in the resistive exercise program. Group B (AE) group: consisted of twenty women who participated in an aerobic exercise program. All patients in both groups (A \& B) participated in the exercises three times per week for twelve weeks and every session lasted for 45 min and continues their antihypertensive medication

Eligibility criteria: Inclusion Criteria:

* All women diagnosed as essential hypertension.
* All women must be in their early postmenopausal period

Exclusion Criteria:

* Lesion to higher centers leading to hypertension (embolism)
* any cardiovascular disease
* premature menopause
* surgical menopause
* severe hypertension
* diabetic
* under treatment of hormonal therapy.

Primary outcomes:
measure: Assessment of changes in the systolic blood pressure
timeFrame: 12 weeks
Secondary outcomes:
measure: Assessment of changes in the diastolic blood pressure
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Al Azhar University
Study officials:
affiliation: Assistant professor of physical therapy for women's health
name: ghada E elrefaye, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01180985: Dispensing Evaluation of a Galyfilcon A Prototype Lens and a Marketed Contact Lens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
First posted: 2010-08-13
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare visual acuity and redness of eyes between a prototype contact lens and an already marketed contact lens.


Eligibility criteria: Inclusion Criteria:

* The subject is a current spherical soft contact lens wearer and willing to wear the study lenses on a daily wear basis for the duration of the study.
* The subject's optimal vertexed spherical equivalent distance correction must be between -1.00 and - 5.00D.
* Any cylinder power must be ≤ -0.75D.
* The subject must have visual acuity best correctable to 20/25+3 or better for each eye.
* The subject must read and sign the Statement of Informed Consent.
* The subject must appear able and willing to adhere to the instructions set forth in the clinical protocol.

Exclusion Criteria:

* Ocular or systemic allergies or disease which might interfere with contact lens wear.
* Systemic disease or use of medication which might interfere with contact lens wear.
* Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear.
* Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear.
* Any ocular infection.
* Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
* Pregnancy or lactation.
* Diabetes.
* Infectious diseases (e.g. hepatitis, tuberculosis) or an immuno-suppressive disease (e.g. HIV).
* Habitual contact lens type is toric, multifocal, or is worn as extended wear.

Primary outcomes:
measure: Visual Acuity Monocular
timeFrame: after 7 +/- 1 days of lens wear
measure: Visual Acuity Binocular
timeFrame: after 7 +/- 1 days of lens wear
measure: Subjective Assessment of Lens Comfort Using the Contact Lens User Experience (CLUE)TM Questionnaire.
timeFrame: after 7 +/-1 days of lens wear
measure: Subjective Assessment of Quality of Vision Using the Contact Lens User Experience(CLUE)TM Questionnaire.
timeFrame: after 7 +/- 1 days of lens wear
Secondary outcomes:
measure: Limbal Redness
timeFrame: after 7 days of lens wear
measure: Bulbar Redness
timeFrame: after 7 days of lens wear
measure: Subjective Assessment of Lens Comfort Using the Contact Lens User Experience (CLUE)TM Questionnaire.
timeFrame: 10 minutes after lens insertion at time of initial lens fitting
Other outcomes:
Locations:
city: Jacksonville
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Fincastle
country: United States
state: Virginia
city: Salem
country: United States
state: Virginia
Study officials:
References:
Clinical trial NCT04679285: Minimal Residual Disease Evaluation on Cryopreserved Ovarian Fragments in Younger Patients Treated for Acute Myeloid Leukemia
Official title: Pilot Study to Assess Minimal Residual Disease on Cryopreserved Ovarian Fragments in Younger Patients Treated for Acute Myeloid Leukemia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Myeloid Leukemia
Keywords: Acute myeloid leukemia
Fertility preservation
Ovarian cryopreservation
Minimal residual disease
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: Canceropôle Nord Ouest
name: Saint-Louis Hospital, Paris, France
First posted: 2020-12-22
Enrollment: 8
Sex: FEMALE
Minimum age (years): 2
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged 2 to 25 year-old, who present at least one molecular marker at acute myeloid leukemia diagnosis and who undergo ovarian cryopreservation for fertility preservation at the time of complete remission, before hematopoietic stem cell transplantation.

Brief summary: Cryopreservation of ovarian cortex represents an option for fertility preservation in patients diagnosed with acute myeloid leukemia and requiring allogeneic stem cell transplantation.

This pilot study aims to evaluate the minimal residual disease on ovarian fragments harvested before allogeneic stem cell transplantation at the time of complete remission.


Eligibility criteria: Inclusion Criteria:

* Patient diagnosed with AML
* At least one molecular marker identified at AML diagnosis
* Patients who undergo ovarian tissue cryopreservation for fertility preservation in complete remission, before hematopoietic stem cell transplantation.

Exclusion Criteria:

* Other diagnostic
* No marker available at AML diagnosis
* No bone marrow/ovarian fragment available at the time of complete remission

Primary outcomes:
measure: Percentage of patients without detectable MRD in ovarian tissue
timeFrame: Up to 6 months
Secondary outcomes:
measure: Percentage of patients with MRD detected in ovarian tissue and bone marrow.
timeFrame: Up to 1 month
Other outcomes:
Locations:
city: Lille
country: France
facility: CHU lille
Study officials:
affiliation: University Hospital, Lille
name: Laurène Fenwarth, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03605485: The Evaluation of a Novel Nasal Pillows Mask for the Treatment of Obstructive Sleep Apnea
Official title: The Evaluation of a Novel Nasal Pillows Mask for the Treatment of Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Lead sponsor: Fisher and Paykel Healthcare
Sponsor class: INDUSTRY
First posted: 2018-07-30
Enrollment: 9
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: This investigation is a prospective, non randomized, non blinded study. This investigation is designed to evaluate the performance, comfort and ease of use with the F\&P trial nasal pillows mask amongst Obstructive Sleep Apnea (OSA) participants.

Detailed description: Visit 1 will involve the participants consented in to the trial. Participants will be fitted with the F\&P trial nasal pillows mask for use in-lab.

The participant will then return the mask and have a interview, this ensures the maximum time participants will be exposed to the trial mask in lab will be in 1 night.

The mask will be returned to the Institution at the conclusion of the trial and the participant will return to their previous mask. The Institution will recruit all participants within 1 week of the beginning of the study.

Eligibility criteria: Inclusion Criteria:

* Adult (18+ years of age)
* Able to give consent
* Apnea hypopnea Index (AHI)≥ 5 on diagnostic night
* Prescribed PAP for OSA
* Existing nasal pillows mask user

Exclusion Criteria:

* Inability to give consent
* Patients who are in a coma or a decreased level of consciousness
* Anatomical or physiological conditions making automatic positive airway pressure (APAP) therapy inappropriate (e.g. unconsolidated facial structure)
* Commercial drivers who are investigated by New Zealand Transport Agency
* Current diagnosis of carbon dioxide (CO2) retention
* Pregnant or may think they are pregnant

Primary outcomes:
measure: Ease of use
timeFrame: 1 night
measure: Acceptability
timeFrame: 1 night
Secondary outcomes:
measure: Objective Leak Data
timeFrame: 1 night
Other outcomes:
Locations:
city: Auckland
country: New Zealand
facility: Fisher & Paykel Helathcare
Study officials:
affiliation: Employee
name: Bhavi Ogra
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01967485: Text Messaging Adherence to Stimulant Medication
Official title: Text Messaging Adherence to Stimulant Medication
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: Attention Deficit Hyperactivity Disorder
Medication adherence
Disease management
Text message
ADHD
Children
Reminder systems
Text Messaging
Telemedicine
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: American Academy of Child Adolescent Psychiatry.
First posted: 2013-10-23
Enrollment: 35
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to determine if an individualized text messaging intervention for the parents of children with Attention Deficit/Hyperactivity Disorder is effective in improving medication adherence and disease management.


Eligibility criteria: Inclusion Criteria:

* Male or female children ages 6-17 years
* A diagnosis of ADHD (inattentive, hyperactive/impulsive, or combined type) according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) based on clinical assessment and supported by a Clinical Global Impression- ADHD (CGI-ADHD) Severity Score of at least 4 (Moderately Ill)
* Has a parent in possession of a cellular phone with text messaging capabilities and is interested in and willing to receive planned text messages
* Has never been treated with stimulant medication, or has begun treatment with stimulant medication within three months of study enrollment.

Exclusion Criteria:

* Any serious, unstable, chronic medical condition, per clinician assessment
* Cardiovascular disease
* Current or past history of seizures
* Treatment with stimulant medication beyond three months prior to enrollment
* Pregnant or nursing females
* Investigator and his/her immediate family; defined as the investigator's spouse, parent, child, grandparent, or grandchild
* Unstable psychiatric illness other than ADHD, including, but not limited to: Autism, Bipolar Disorder, Psychosis, Major Depressive Disorder, Anorexia, Bulimia, Post-Traumatic Stress Disorder and Anxiety Disorders
* History of multiple adverse drug reactions
* Presence of suicidal risk, or homicidality
* Unwilling/unable to comply with study procedures
* Poor command of the English language

Primary outcomes:
measure: Medication Adherence
timeFrame: Six Months
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Mai Uchida, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01255085: Yellow Pea Protein and Fibre and Short Term Food Intake
Official title: The Effect of Yellow Pea Protein and Fiber on Short Term Food Intake, Subjective Appetite and Glycemic Response in Healthy Young Males
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Type II Diabetes Mellitus
Metabolic Syndrome
Keywords: Obesity
Food intake regulation
blood glucose regulation
protein
fiber
pulses
yellow peas
Lead sponsor: University of Toronto
Sponsor class: OTHER
Collaborators: name: Agriculture and Agri-Food Canada
First posted: 2010-12-07
Enrollment: 20
Sex: MALE
Minimum age (years): 20
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: It is hypothesized that yellow pea protein and fiber will reduce short-term food intake, subjective appetite and glycemic response.

Detailed description: A within-subject, randomized study was conducted. Each subject returned 5 times, 1 week apart, and received 1 of the 5 treatments per week. The 5 treatments were tomato soup with 10 or 20 g of isolated yellow pea fibre or protein, or a control soup with no added pea fractions. Food intake was measured at an ad libitum pizza meal served 30 minutes after treatment. Satiety and blood glucose (via finger prick) were measured throughout the treatment period.

Eligibility criteria: Inclusion Criteria:

* male 20-30 years old healthy weight

Exclusion Criteria:

* smoking restrictive eating metabolic diseases breakfast skippers dieters

Primary outcomes:
measure: Energy Intake
timeFrame: at 30 minutes after treatment
Secondary outcomes:
measure: Glycemic Response
timeFrame: 0-170 minutes post treatment
measure: Subjective Appetite
timeFrame: 0-170 minutes post treatment
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University of Toronto - Department of Nutritional Sciences
state: Ontario
Study officials:
References:
Clinical trial NCT00970385: Study About Treatment of Newly Diagnosed Non Cutaneous Peripheral T Cell Lymphoma
Official title: Multicentric Study About Treatment of High Grade Peripheral T Cell Lymphoma in Adults. LTP Study Comparison Between VIP ABVD Versus CHOP
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Peripheral T Cell Lymphoma
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: French Innovative Leukemia Organisation
First posted: 2009-09-02
Enrollment: 95
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: This is a multicenter randomized trial evaluating induction treatment with VIP-reinforced-ABVD (VIP-rABVD) versus CHOP/21 in patients with newly diagnosed peripheral T cell lymphoma.

Detailed description: Induction therapy:

ARM 1: 6 Chemotherapy courses = 3 VIP alternated with 3 ABVD ARM 2: 8 Chemotherapy courses = CHOP every 21 days

Consolidation therapy:

For all patients if CR = radiotherapy 40GY / 5X1,8 GY per week

Eligibility criteria: Inclusion Criteria:

* newly diagnosed untreated PTCL
* age 18 and 70 years
* performance status ≤ 2
* Ann Arbor stage I to IV
* normal cardiac ventricular ejection fraction over 50%
* normal hepatic function (asat, ALAT, PAL \< 2.5 ULN)

Exclusion Criteria:

* cutaneous form of PTCL
* previous treatment
* age \< 18 and \> 70
* performance status \> 2
* abnormal cardiac or hepatic functions
* HIV-, HCV- or HBV- positivity

Primary outcomes:
measure: Comparison between EFS rate of CHOP/21 versus VIP-rABVD in newly diagnosed PTCL.
timeFrame: 2 years
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: 6 years
measure: response rate at the end of the treatment
timeFrame: 6-8 months
measure: progression free survival (PFS)
timeFrame: 6 years
measure: hematotoxicity
timeFrame: 6 months
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Dr REMY GRESSIN
Study officials:
affiliation: CHU Grenoble GOELAMS
name: Remy GRESSIN, MD MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03965585: Office Hysteroscopy in Infertility Work-out: the Role of Endometrial Hyperplasia in Southern Italian Women
Official title: Office Hysteroscopy in the Infertility Work-out: the Role of Endometrial Hyperplasia in Southern Italian Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility, Female
Endometrial Hyperplasia
PCOS
Lead sponsor: University of Campania Luigi Vanvitelli
Sponsor class: OTHER
First posted: 2019-05-29
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Southern Italian women eager for children who are set for infertility work-up at a tertiary university hospital

Brief summary: To assess the prevalence of endometrial hyperplasia (EH), endometrial intraepithelial neoplasia (EIN) and endometrial carcinoma between obese and not obese women undergoing IVF techniques for primary or secondary infertility.

Detailed description: Endometrial cancer and pre-neoplastic diseases represent the most incident gynecologic malignant pathologies found in women.1 Although diagnosed in postmenopausal patients, it can be also found in younger patients, especially when associated with some risk factors. Those include weight gain and lifestyle habits, such as consumption of fatty foods that increase estrogen levels. The positive association be- tween infertility and EC is well established. Infertile women with irregular menstrual periods, oligomenorrhea, or chronic anovulation have a risk of developing

A prospective cohort study conducted at "Fertility Center, OB/GYN Unit, Department of Woman, Child and General and Specialized Surgery, University of Campania "Luigi Vanvitelli", Naples, Italy".

Eligibility criteria: Inclusion Criteria:

* Women undergoing office hysteroscopy prior to IVF techniques

Exclusion Criteria:

* Severe comorbidities (i.e. cardiac, metabolic, neurologic diseases)

Primary outcomes:
measure: Prevalence of endometrial hyperplasia
timeFrame: 12 months
measure: Hormonal levels
timeFrame: 12 months
Secondary outcomes:
measure: Operator's learning curve with cumulative summation test (questionnaire)
timeFrame: 12 months
Other outcomes:
Locations:
city: Naples
country: Italy
facility: Department of Woman, Child and General and Specialized Surgery, University of Campania "Luigi Vanvitelli"
Study officials:
References: