louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02903693: Cervical Cancer in French Guiana: Screening Between 2006-2011
Official title: Cervical Cancer in French Guiana: Screening Between 2006-2011. Description of the Population With Invasive Cervical Cancer Between 2003-2008
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervical Cancer
Lead sponsor: Centre Hospitalier de Cayenne
Sponsor class: OTHER
First posted: 2016-09-16
Enrollment: 91458
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all women screened for cervical cancer using pap smear

Brief summary: Given that cervical cancer is the second most frequent cancer among women in french guiana the aim of the study was to determine the screening rate among women living in French Guiana. Cervical smears are read in 2 laboratories which allowed us to compute screening rates per 100 women-years. overall the screening activity was 23.5-25.8 smears per 100 women-years. between 2006 and 2011 54% of women were screened. These baseline figures will allow to evaluate present efforts to increase the screening rate for this frequent cancer in French Guiana.


Eligibility criteria: Inclusion Criteria:

* women screened

Exclusion Criteria:

-

Primary outcomes:
measure: cervical cancer screening
timeFrame: 1 year (screening that year)
Secondary outcomes:
Other outcomes:
Locations:
city: Cayenne
country: France
facility: Centre Hospitalier de Cayenne
state: French Guiana
Study officials:
References:
Clinical trial NCT01758393: Glucocorticoids in Patients With IgG4-RD
Official title: A Randomized Trial of Glucocorticoids in Patients With IgG4-Related Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: IgG4-related Disease
Keywords: IgG4-related disease
IgG4-RD
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2013-01-01
Enrollment: 40
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 randomized, open-label, single-center clinical trial to compare the efficacy and safety profile for medium-dose versus high dose glucocorticoid in patients with IgG4-related Disease. Patients will be followed for three months to measure the primary outcome and secondary outcomes.


Eligibility criteria: Inclusion Criteria:

* Males and females
* Age 18-70 years old with informed consent
* Patients with IgG4-RD:

  1. swelling, sclerosing and inflammatory involvement of one or more organ, including sclerosing pancreatitis, sclerosing cholangitis, inflammatory pseudotumors, retroperitoneal or mediastinal fibrosis, interstitial nephritis, hypophysitis, sclerosing dacryoadenitis, sialadenitis, inflammatory aortic aneurysm, lymphadenopathy, or other inflammatory conditions;
  2. elevated serum IgG4 (\>1.35 g/L)
  3. histopathologic features of fibrosis and/or lymphocytic and polyclonal plasma cell infiltration (and IgG4+ plasma cells on immunohistology when performed);
  4. exclusion of other diseases.

Exclusion Criteria:

* Previously or currently received glucocorticoid and(or) immunomodulator
* Pregnancy or lactating
* Concurrent severe and/or uncontrolled and/or unstable diseases
* Patient with malignancy

Primary outcomes:
measure: Complete Response
timeFrame: 3 months
Secondary outcomes:
measure: Disease Response
timeFrame: 3 months
measure: Adverse Effect
timeFrame: 3 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Deptment of Rheumatology, Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Deptment of Rheumatology, Peking Union Medical College Hospital
name: Wen Zhang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Deptment of Rheumatology, Peking Union Medical College Hospital
name: Fengchun Zhang
role: STUDY_CHAIR
References:
Clinical trial NCT03012893: Identification of C7; Evaluations of 2 Sonographic Methods Using a Transverse and a Sagittal Scan.
Official title: Identification of the C7 Vertebral Level; Evaluations of Two Sonographic Methods Using a Transverse Scan of the C7 Transverse Process and a Sagittal Scan of the First Rib.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breastcancer
Keywords: ultrasonography to identify C7 spinous process
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2017-01-06
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: To determine the accuracy of two techniques (transverse scan and sagittal scan) using ultrasonography to identify C7 spinous process compare to the fluoroscope (standard technique)

Detailed description: To identify the accurate level of upper thoracic spine is essential maneuver during breast surgery and axillary node dissection. Palpation C7 spinous process is most common technique using to identify the level. However, the accuracy was lower than 50%. Ultrasonography has been investigated to identify the cervical nerve roots by differentiating the transvers process of C6 and C7. However, there was no study on the accuracy of using ultrasound to identify cervical spine level before.

Eligibility criteria: Inclusion Criteria:

* healthy volunteer, age \>/= 18

Exclusion Criteria:

* previous cervical spine surgery, cervical spine deformity, pregnancy

Primary outcomes:
measure: the accuracy of identify C7 spinous process
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06169293: Evaluation of an Interactive Mental Wellness (I-AM-WELL) Program on Final Year Nursing Students
Official title: Evaluation of an Interactive Mental Wellness (I-AM-WELL) Program on Final Year Nursing Students: A Mixed Methods Evaluation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Resilience
Practice Readiness
Depression
Anxiety
Stress
Physical Activity
Eating Behavior
Lead sponsor: National University of Singapore
Sponsor class: OTHER
First posted: 2023-12-13
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study aims to address the following research questions:

Evaluate the effectiveness of an Interactive Mental Wellness (I-AM-WELL) program on final year nursing students' anxiety, depression, stress, resilience, practice readiness, physical activity and eating behaviours.

Explore final year nursing students' experiences and perception of the I-AM-WELL program.

Participants will be invited to participate in an asynchronous online I-AM-WELL program


Eligibility criteria: Inclusion Criteria:

* Final year nursing students enrolled in the undergraduate nursing program
* Above the ages of 18 years
* Able to comprehend the English language
* Have a device that can connect to the Internet

Exclusion Criteria:

* Students who refused to participate in the study

Primary outcomes:
measure: Resilience
timeFrame: Before training
measure: Resilience
timeFrame: Immediately after training
measure: Depression, Anxiety and Stress
timeFrame: Before training
measure: Depression, Anxiety and Stress
timeFrame: Immediately after training
measure: Practice Readiness
timeFrame: Before training
measure: Practice Readiness
timeFrame: Immediately after training
measure: Physical Activity
timeFrame: Before training
measure: Physical Activity
timeFrame: Immediately after training
measure: Eating behaviours
timeFrame: Before training
measure: Eating behaviours
timeFrame: Immediately after training
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: National University of Singapore
name: Darryl Ang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01390493: Therapeutic Effects of Neurofeedback in Anorexia Nervosa
Official title: Therapeutic Effects of Alpha-neurofeedback in the Treatment of Anorexia Nervosa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Anorexia Nervosa
Keywords: neurofeedback, alpha, anorexia nervosa
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2011-07-11
Enrollment: 12
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether neurofeedback training can significantly reduce the symptoms of anorexia nervosa (AN) with focus on changes in personality and psychological well-being. The primary aims of this study include:

1. To examine whether AN patients are able to control their alpha-activity through neurofeedback.
2. To examine the effects of neurofeedback on symptomatology and personality variables in AN patients.
3. To examine the long-term effects of neurofeedback in the treatment of AN.

Detailed description: The aim of the present study is to investigate the impact of EEG frequency band biofeedback (neurofeedback) training on EEG topography and symptomatology of patients suffering from anorexia nervosa (AN).

There is evidence that alpha-neurofeedback leads to an increase in positive therapy outcome in clinical populations by changing long-lasting EEG frequency patterns. The use of an EEG-guided relaxation paradigm has been shown to be associated with well-being and improvements in pathology of psychiatric patients.

In the present study the effects of alpha-training on EEG activity, mood, personality, well-being, blood parameters, and heart frequency will be evaluated in a sample of anorectic girls (12-18 years).

The subjects are trained with at least 10 sessions alpha-neurofeedback, in order to enhance individual alpha frequency, with spectral resting EEG, EKG, blood samples, ERP-measures and psychometric measures assessed before and after training. Neurofeedback is conducted over a period of five weeks, with each participant receiving two training sessions per-week. Neurofeedback is administered using USBAmp-EEG system.

For better surveillance of training effects there are two non-treatment control groups. A patient group receiving conventional therapy programme of the Psychosomatic Division of the Pediatric Department at the University Hospital Graz and a healthy control group.

A twelve-week follow-up study is carried out in order to document long-term effects of alpha-neurofeedback training in AN patients.

Eligibility criteria: Inclusion Criteria:

* anorexia nervosa diagnosed by ICD-10

Exclusion Criteria:

* epilepsy or other brain organic diseases

Primary outcomes:
measure: brain activity in the alpha band
timeFrame: 10 sessions neurofeedback
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Department of Psychology, Karl-Franzens-University Graz
name: Nina Lackner, Mag.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02425293: INCAS - Integrated Care of Asthma in Switzerland
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Lead sponsor: Cantonal Hosptal, Baselland
Sponsor class: OTHER
First posted: 2015-04-23
Enrollment: 223
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study was to investigate the effect of standardized patient education on asthma control. In collaboration with two health insurance companies, pharmacists and pneumologists, patients with asthma were recruited. They completed the "Asthma Control Test (ACT)" and the "Patient Assessment of Chronic Illness Care (PACIC 5A)" questionnaire to assess asthma control and patients' satisfaction with the health care service they received. Additionally, patients were offered the possibility to participate in a patient education seminar run by the Swiss lung leagues or the Swiss allergy centre (aha!). After one year, patients were asked to complete the questionnaires again. Comparisons of intraindividual changes and differences regarding ACT and PACIC 5A between patients with and without patient education were made.


Eligibility criteria: Inclusion Criteria:

* patients with clinical asthma diagnosis
* written informed consent

Exclusion Criteria:

* inadequate knowledge of the German language
* subjects with severe diseases with life expectancy under one year
* subjects with known Chronic Obstructive Pulmonary Disease (COPD)

Primary outcomes:
measure: Comparison of patient characteristics between the intervention and the control group
timeFrame: baseline
measure: Comparison of asthma control between the intervention and the control group
timeFrame: baseline
measure: Comparison of patient satisfaction between the intervention and the control group
timeFrame: baseline
Secondary outcomes:
measure: Comparison of asthma control at baseline and after one year in the intervention group.
timeFrame: baseline and follow up (after one year)
measure: Comparison of asthma control at baseline and after one year in the control group.
timeFrame: baseline and follow up (after one year)
measure: Comparison of patient satisfaction at baseline and after one year in the intervention group.
timeFrame: baseline and follow up (after one year)
measure: Comparison of patient satisfaction at baseline and after one year in the control group.
timeFrame: baseline and follow up (after one year)
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02344693: Electroencephalography in Patients Resuscitated From Cardiac Arrest
Official title: Electroencephalography in Patients Resuscitated From Cardiac Arrest
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiac Arrest
Heart Arrest
Keywords: Electroencephalography
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2015-01-26
Enrollment: 40
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 resuscitated from a non-traumatic cardiac arrest in a urban setting in southern Finland

Brief summary: Sudden cardiac death can occur due to a multitude of causes. The underlying case can affect the overall prognosis. A return of spontaneous circulation not exceeding 30 minutes following a successful cardiopulmonary resuscitation is usually deemed imperative, if the patient is to survive. Monitors for evaluating the cardiac function during and after resuscitation are implemented on a daily basis (ekg, pulseoxymetry, blood pressure monitoring, cardiac sonography), but no devices for registration of the cortical brain activity exist. The aim of this study is to provide a 3-channel electroencephalogram using a prototype EEG/EKG adapter, connected to a Physio-Control LifePak 15 monitor/defibrillator, in patients who regain spontaneous circulation following non-traumatic cardiac arrest.


Eligibility criteria: Inclusion Criteria:

* Witnessed Cardiac Arrest
* Return of spontaneous circulation following cardiac arrest 10-40 min

Exclusion Criteria:

* traumatic cardiac arrest
* no consent from next-of-kin

Primary outcomes:
measure: prehospital EEG value in regard to patient discharge
timeFrame: 60-min
Secondary outcomes:
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Central Hospital
Study officials:
affiliation: Helsinki University Central Hospital
name: Johannes Björkman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Helsinki University Central Hospital
name: Tom Silfvast, MD, PhD
role: STUDY_DIRECTOR
affiliation: Helsinki University Central Hospital
name: Tapani Salmi, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05910411: Inelastic Compression in Edema After Revascularization
Official title: Inelastic Compression in Edema After Revascularization
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lymphedema
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2023-06-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The appearance of revascularization edema of the lower limb is a frequent complication in peripheral vascular surgery. It can lead to a delay in healing and even to trophic disorders.

The prevention and treatment of this complication have so far been limited to postural measures (elevation of the limbs), in the absence of other recommendations and given the contraindication of elastic compression.

Inelastic compression is another mode of compression sometimes used in the treatment of lymphedema. It exerts a stable continuous pressure regardless of the patient's position. The investigator's aim is to demonstrate that compression with inelastic bands, applied under good conditions, does not have a major effect on distal arterial vascularization in arterial patients who have undergone revascularization by supra-articular bypass or endovascular treatment of the lower limb.


Eligibility criteria: Inclusion Criteria:

1. patients over 18 years of age
2. arteriopathic patients requiring femoropopliteal revascularization by bypass surgery who have been revascularized
3. signature of an informed consent
4. person affiliated or beneficiary of a social security plan

Exclusion Criteria:

1. arterial bypasses under the leg or distal joints
2. critical ischemia
3. patients operated on for acute ischemia
4. pregnant or breast-feeding women
5. severe cardiac insufficiency

5) severe peripheral neuropathy 6) allergies to the components of the tapes 7) persons deprived of liberty by judicial or administrative decision 8) persons under legal protection

Primary outcomes:
measure: Evaluating the safety of inelastic compression
timeFrame: day 5
Secondary outcomes:
measure: threshold of cPSI below which the application of inelastic compression results in altered arterial flow.
timeFrame: day 5
measure: toe pressure below which the application of inelastic compression results in altered arterial flow.
timeFrame: day 5
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de Nice
Study officials:
affiliation: Centre Hospitalier Universitaire de Nice
name: PASCAL GIORDANA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01854411: Study of Analgesics Drug and Human Milk Transfer in Mature Milk, to Avoid Breastfeeding Cessation Without Scientific Probes
Official title: Ibuprofen and Ketoprofen Concentrations in Human Mature Milk. PK Study in Breastmilk AOR-10127 "Antalait" Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Analgesics Use During Breastfeeding and Concentrations in Human Mature Milk
Keywords: Analgesics
Ibuprofene
Ketoprofene
Breastmilk
Relative Infant Dose
Theoric Infant Dose
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2013-05-15
Enrollment: 35
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Lactarium, Maternal care, Consultant of Lactation

Brief summary: The purpose of this study is to determine whether ibuprofen and ketoprofen do not enter into mature breastmilk that could allowed breastfeeding during a long time

Detailed description: Analgesics are frequently used to prevent and treat pain and inflammatory disease.

Due to a lack of information on drug's human milk transfer, breastfeeding is sometimes contraindicated. Mothers are advised to either stop breastfeeding or if they don't, not to treat themselves. Since the fatal neonatal case with codeine during breastfeeding, analgesics are being reviewed. Ibuprofen seems to have the best benefit-risk ratio during the post-partum period. However there are no pharmacologic data about the use of ibuprofen during breastfeeding, after the colostrum phase.

This study aims to determine the relative infant dose (RID) of ibuprofen in human mature milk. Considering the increased interest in NSAIDs in light of the codeine case, this is an important information. It will help health practitioners when advising and treating breastfeeding women.

Eligibility criteria: Inclusion Criteria:

* breastfeeding women after the first week of delivery
* breastfeeding women treated by ketoprofen or ibuprofen per os more than 24 hours
* Written Informed Consent

Exclusion Criteria:

* breastfeeding women treated by naproxene
* Curator or justice decision's

Primary outcomes:
measure: concentration of ibuprofene in human mature milk.
timeFrame: 6 months
measure: concentration of ketoprofene in human mature milk
timeFrame: 6 months
Secondary outcomes:
measure: comparison between ibuprofene and ketoprofene concentrations in the human breastmilk
timeFrame: 6 months
Other outcomes:
Locations:
city: Paris
country: France
facility: hopital Saint Antoire
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: virginie rigourd, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT04811911: Evaluation of the Effect of Narrowband UVB Versus Methotrexate on Serum TWEAK Level in Psoriasis
Official title: Evaluation of the Effect of Narrowband Ultraviolet B Versus Methotrexate on Serum TWEAK Level in Psoriasis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Psoriasis
Lead sponsor: Aswan University Hospital
Sponsor class: OTHER
First posted: 2021-03-23
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to evaluate the effect of NB-UVB versus MTX on serum TWEAK level in psoriatic patients.


Eligibility criteria: Inclusion Criteria:

* Patients with moderate to severe plaque psoriasis of any age and gender.

Exclusion Criteria:

* History of psoriasis treatment with systemic and biological agents prior to the study for at least 3 months.
* Pregnancy and lactation.
* Infections
* Patients with chronic diseases: hepatic disorders, hematologic disease, chronic renal failure or cancer

Primary outcomes:
measure: Serum TWEAK in psoriasis
timeFrame: 3 months
Secondary outcomes:
measure: Treatment of psoriasis
timeFrame: 3 months
Other outcomes:
Locations:
city: Aswan
country: Egypt
facility: Aswan University - Faculty of Medicine
state: Aswan Governorate
Study officials:
affiliation: Faculty of medicine aswan university
name: Moustafa A El Taieb, Professor
role: STUDY_CHAIR
References: