louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01823601: Behavioral Management and Psychological Well-Being
Official title: A Cognitive-Behavioral Program Of Emotional Management and Feeling Of Psychological Well-Being
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychological Well Being
Behavioral Management
Keywords: Well-Being
Life Management Program
Breathing
Meditation
Cognitive-Behavioral Training
Lead sponsor: Centro de Estudos em Medicina Comportamental
Sponsor class: OTHER
First posted: 2013-04-04
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The aim of present study is to evaluate whether a program of behavioral and cognitive procedures for emotional control, and assertive training, produces well-being and improvement in quality of life of healthy volunteers.

Detailed description: Healthy volunteers,not presenting neurologic or psychiatric disorders, 18 years or older,both genders, were selected, after a medical examination, to participate in the study. In a randomized controlled trial, the volunteers were submitted to sessions of muscle relaxation (autogenic method), progressive self-focus meditation, and cognitive-behavioral training in self-control of negatives feelings. They were also trained to determine goals and to determine each step to reach them (plan of action).The volunteers have to apply this strategy to control emotional behavior and improve interpersonal relationship. Anxiety and depression scores will be determined using the Beck self evaluation scales (BDI and BAI); quality of life will be determined using WHO-QOL inventory and the Ryff Scale will be used to measure Psychological Well-Being.

Eligibility criteria: Inclusion Criteria:

* Healthy people, without neurological or psychiatry disorders, according to the results of a medical examination
* 18 years or older
* high school degree

Exclusion Criteria:

* Severe neurological or psychiatric disorders

Primary outcomes:
measure: Depression and Anxiety scores in Beck Depression Inventory and Beck Anxiety Inventory
timeFrame: Up to 3 month
Secondary outcomes:
measure: Evaluation of Well-Being scores in 6 factors of Psychological Well-Being in Ryff scale
timeFrame: Up to 3 month
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Universidade Federal de Sao Paulo
state: SP
Study officials:
References:
Clinical trial NCT03474601: Seoul National University Pituitary Disease Cohort Study
Official title: Seoul National University Pituitary Disease Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pituitary Disease
Pituitary Incidentaloma
Acromegaly
Central Diabetes Insipidus
Pituitary Stalk Compression Hyperprolactinaemia
Cushing's Disease
Pituitary Tumor
Prolactinoma
Keywords: Pituitary Diseases
Pituitary incidentaloma
Central Diabetes Insipidus
Pituitary Neoplasms
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2018-03-22
Enrollment: 1600
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 diagnosed with pituitary disease at Seoul National University Hospital

Brief summary: The purpose of this study is to investigate the treatment and natural history of pituitary disease. We have a longstanding interest in pituitary disease including acromegaly, central diabetes insipidus, and nonfunctioning pituitary adenoma. We will continue to follow patients and recruit new patients for treatment and follow-up. Blood and pituitary tumor tissue (when available through clinical care) will be saved for future analyses related to pituitary disease.

Detailed description: Subjects for this study will be recruited if they are:

1. Adults, male or female aged 18 years or older
2. Have been diagnosed with pituitary diseases

Eligibility criteria: Inclusion Criteria:

* Subjects for this study will be recruited if they are:

  1. Adults, male or female aged 18 years or older
  2. diagnosed with pituitary diseases such as acromegaly, Cushing's disease, hyperprolactinemia, nonfunctioning pituitary adenoma, pituitary stalk lesions, central diabetes insipidus, and craniopharyngiomas

Exclusion Criteria:

* Patients who do not agree with the study

Primary outcomes:
measure: Treatment outcome of pituitary diseases
timeFrame: Up to 10 years
Secondary outcomes:
measure: Complications of pituitary disease
timeFrame: Up to 10 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jung Hee Kim, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04411901: The Role of Vitamin D3 in Pediatric Bronchiectasis Severity
Official title: The Role of Vitamin D3 in Pediatric Bronchiectasis Severity( CF Versus Non CF Bronchioectasis)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Cystic Fibrosis and Non CF Bronchiectasis
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2020-06-02
Enrollment: 40
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Vitamin D3 therapy was effective in decreasing the frequency of pulmonary exacerbations and preserving lung functions , thereby improving the disease severity even more in non CF than CF bronchiectasis patients

Detailed description: Objectives: To compare the effect of vitamin D3 on modifying the disease severity in CF and non CF bronchiectasis pediatric patients.

Patients and Methods: This was a randomized clinical trial evaluating the role of oral vitamin D3 supplementation for 6 months in forty patients with CF and non CF bronchiectasis under the age of 18 years with vitamin D deficiency or insufficiency . The primary outcome was to reach the sufficient Vitamin D level. The secondary outcome was to follow up the frequency of pulmonary exacerbations and lung function after vitamin D3 supplementation.

Eligibility criteria: Inclusion Criteria:

* ages less than 18 years .
* Patients with documented diagnosis of CF (by the presence of a twice positive sweat chloride test and or paired CFTR DNA genetic mutations).
* Patients with non CF bronchiectasis diagnosed clinically and radiologically ( sweat chloride test negative) with a high resolution CT-confirmed diagnosis and clinical history consistent with bronchiectasis .
* Vitamin D deficient or insufficient CF and non CF bronchiectasis patients

Exclusion Criteria: if they had

* sufficient Vitamin D level .
* chronic lung diseases other than CF and non CF bronchiectasis , liver or renal diseases.
* reported taking vitamin-D supplements or steroid therapy in the last 6 weeks.

Primary outcomes:
measure: reach sufficient vitamin D level
timeFrame: 6 months
measure: decrease disease severity
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Children hospital
state: Abbasia
Study officials:
References:
Clinical trial NCT06870201: Iron Absorption from Lipid-Based Nutrient Supplements
Official title: Dietary Iron Absorption from Lipid-Based Nutrient Supplements - a Pilot Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Undernutrition
Healthy
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
Collaborators: name: Jomo Kenyatta University of Agriculture and Technology
First posted: 2025-03-11
Enrollment: 30
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Participants will be recruited from Msambweni and the surrounding rural communities in Kwale County, Kenya.

Brief summary: The overall objective of this study is to determine dietary iron absorption from lipid-based nutrient supplements (LNS) in apparently healthy and undernourished children. This case-control study will recruit apparently healthy children and children with uncomplicated undernutrition (age 1-3 years, n=15/group) from Msambweni and the surrounding rural communities in Kwale County, Kenya. At the baseline visit (day 0), participants will be provided with an LNS labeled with a stable iron isotope (57-Fe). Participants will return to the hospital 14 days later (day 14) for a blood draw. Blood collected on day 14 will be used to measure iron isotope incorporation into red blood cells. Blood collected at screening will be used to measure indicators of anemia, iron status, hepcidin, and inflammation.


Eligibility criteria: Inclusion Criteria:

* Children age 1-3 years on day of screening visit
* Hemoglobin 8-11 g/dL on day of screening visit
* Undernourished \[length/height-for-age z-score (HAZ), weight-for-age z-score (WAZ), and/or weight-for-height/length z-score (WHZ) \< -2\] OR apparently healthy (HAZ, WAZ, and/or WHZ ≥ -1)

Exclusion Criteria:

* Severe acute malnutrition (WHZ \< -3) with no appetite
* Serious medical condition or other chronic disease besides undernutrition (e.g., HIV+, severe pneumonia, malaria)
* Peanut allergy or other allergy that prevents consumption of the LNS
* Plans to move away from the study location during the study period

Primary outcomes:
measure: Dietary iron absorption
timeFrame: Isotope incorporation into RBCs on day 14
Secondary outcomes:
measure: Hemoglobin
timeFrame: Measured at screening
measure: Serum ferritin
timeFrame: Measured at screening
measure: Soluble transferrin receptor
timeFrame: Measured at screening
measure: Transferrin saturation
timeFrame: Measured at screening
measure: Hepcidin
timeFrame: Measured at screening
measure: C-reactive protein
timeFrame: Measured at screening
measure: Alpha-1-acid glycoprotein
timeFrame: Measured at screening
Other outcomes:
Locations:
Study officials:
affiliation: Pennington Biomedical Research Center
name: Stephen Hennigar, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06729801: Intrarenal Pressure Monitoring Via Flexible and Navigable Suction Ureteral Access Sheath in Retrograde Intrarenal Surgery
Official title: Intrarenal Pressure Monitoring Via Flexible and Navigable Suction Ureteral Access Sheath in Retrograde Intrarenal Surgery: A Pilot Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Stone
Keywords: RIRS
FANS
Lead sponsor: The First Affiliated Hospital of Guangzhou Medical University
Sponsor class: OTHER
First posted: 2024-12-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the use of a novel intrarenal pressure (IRP)-monitoring flexible and navigable suction ureteral access sheath (FANS) in retrograde intrarenal surgery (RIRS) for renal stones. The prospective clinical trial compares its efficacy and safety against conventional FANS in 100 patients. The primary outcomes include IRP monitoring accuracy, operative time, stone-free rate (SFR), and complication rates, with the aim of improving stone retrieval efficiency and procedural safety in RIRS. This trial seeks to validate the innovative device's role in expanding RIRS indications, especially for large renal stones.


Eligibility criteria: Inclusion Criteria:

1. Adult patients (18-75 years old) diagnosed with renal stones (size ≤4 cm) and suitable for retrograde intrarenal surgery (RIRS).
2. Willing to provide informed consent.
3. No significant renal, cardiac, or systemic diseases that may interfere with the surgical procedure or the study.
4. Preoperative intravenous pyelography (IVP) showing no significant ureteral stricture.

Exclusion Criteria:

1. Patients with active urinary tract infections (UTIs) or fever at the time of surgery.
2. Pregnancy or breastfeeding women.
3. Patients with a history of severe renal disease (e.g., chronic kidney disease stage 3 or higher).
4. History of prior ureteral or renal surgery that may affect the anatomy.
5. Patients with uncontrolled comorbidities such as uncontrolled diabetes, hypertension, or cardiovascular disease.
6. Patients who are unwilling or unable to comply with the study protocol.

Primary outcomes:
measure: Operative Time
timeFrame: Measured during the surgical procedure, from the start of the surgery to the end of the procedure (estimated duration: 30-60 minutes per patient).
Secondary outcomes:
measure: Stone-Free Rate (SFR)
timeFrame: 24-48 hours post-surgery, based on CT scan results.
measure: Postoperative Complications
timeFrame: Evaluated within 30 days post-surgery.
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guohua Zeng
state: Guangdong
Study officials:
References:
Clinical trial NCT01132001: Ambulatory Versus Home Blood Pressure Measurement
Official title: EVALUATION OF BLOOD PRESSURE MEASUREMENTS OUTSIDE OFFICE: COMPARISON OF DIAGNOSIS BASED ON EITHER AMBULATORY OR HOME BLOOD PRESSURE MEASUREMENTS
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Arterial Hypertension
Lead sponsor: University of Athens
Sponsor class: OTHER
First posted: 2010-05-27
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects referred to an outpatient hyperetension clinic for arterial hypertension

Brief summary: This is a prospective study comparing the three blood pressure monitoring methods on the diagnosis of arterial hypertension. Blood pressure of each subject will be evaluated with clinic, home and 24h ambulatory blood pressure measurements in three visits


Eligibility criteria: Inclusion Criteria:

* Age \> 20 yrs
* Patients referred to an outpatient clinic for high blood pressure
* Patients with no treatment or with antihypertensive treatment stable for at least 4 weeks.
* Patients capable of performing home blood pressure measurements.
* Signed informed consent

Exclusion Criteria:

* Hypertension stage III (SBP\>180 mmHg or DBP\>110mmHg)
* Secondary hypertension
* Resistant hypertension
* Arrhythmia
* Pregnancy
* Symptomatic heart disease
* Renal disease (Cr\>2mg/dl)
* Uncontrolled diabetes mellitus (HbA1c\>8.5%)

Primary outcomes:
measure: Blood pressure monitoring methods
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Hypertension Center, Third Department of Medicine, University of Athens, Greece
Study officials:
affiliation: Hypertension Center,Third Department of Medicine,University of Athens,Greece
name: George S Stergiou, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01207401: Paracervical Block Before Intrauterine Device (IUD) Insertion
Official title: Pain Control for Intrauterine Device Insertion: A Randomized Trial of 1% Lidocaine Paracervical Block
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain Control for Intrauterine Device Insertions
Keywords: intrauterine device
local anesthetic
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2010-09-22
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate if a paracervical block containing 1% lidocaine administered prior to IUD insertion reduces insertion pain. The hypothesis is that women receiving paracervical analgesia will experience less pain during IUD insertion than those who do not receive such analgesia.


Eligibility criteria: Inclusion Criteria:

* Women age 18 -50 years
* A negative urine pregnancy test and clinically unlikely to be pregnant
* Seeking an intrauterine device for any indication
* Willing and able to sign an informed consent in English

Exclusion Criteria:

* History of a prior IUD successful insertion
* Previous failed insertion of an IUD
* Known copper allergy
* Known levonorgestrel allergy
* Known lidocaine allergy
* Current cervicitis
* Pelvic Inflammatory Disease (PID) within 3 months
* Pregnancy within six weeks prior to IUD insertion
* Uterine anomaly or distortion of the uterine cavity
* Use of any other pain medication within 6 hours prior to IUD insertion
* Use of misoprostol within 24 hours prior to IUD insertion

Primary outcomes:
measure: Median Visual Analogue Score Measuring Pain
timeFrame: 1) Speculum placement 2) Tenaculum placement 3) Paracervical block administration(if subject is in this arm) 4) IUD insertion 5) Five minutes post procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Medical Faculty Foundation or Prentice Ambulatory Care Clinic
state: Illinois
Study officials:
affiliation: Northwestern University
name: Jessica Kiley, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00758901: ROCC Knee Data Collection
Official title: A Prospective, Multicentre Study Evaluating the Clinical Performance of the ROCC Knee Prosthesis
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Arthritis of Knee
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
Collaborators: name: Biomet France SARL
First posted: 2008-09-25
Enrollment: 200
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: Consecutive series of patients received ROCC Knee prostheses for osteoarthritis, rheumatoid arthritis and bone necrosis affecting two knee compartments, correction of genu varus, genu valgus or post-traumatic deformities, sequelae of prior procedures

Brief summary: This observational study intends to collect efficacy and safety data on ROCC Knee system.

Detailed description: The ROCC® prosthesis is a rotating platform with:

* Highly congruent surface contact,
* NON CONSTRAINED kinematics allowing posterior roll back until 110° then anterior in hyperflexion like a normal knee
* Allowing asymmetric movement

Eligibility criteria: Patients suitable for Knee Replacement for:

* osteoarthritis,
* rheumatoid arthritis
* bone necrosis affecting two knee compartments,
* correction of genu varus, genu valgus or post-traumatic deformities,
* sequelae of prior procedures.

Primary outcomes:
measure: American Knee Score
timeFrame: 3 months, 1yr, 2yr, 3yr, 4yr and 5 yr
Secondary outcomes:
measure: Complication
timeFrame: Any time
measure: Patient Satisfaction
timeFrame: 3 months, 1yr, 2yr, 3yr, 4yr and 5 yr
Other outcomes:
Locations:
city: Gmunden
country: Austria
facility: A. ö Landeskrankenhaus Gmunden
city: Meulin
country: France
facility: Clinique des Fontaines
city: Almeria
country: Spain
facility: Hospital Torrecardenas
Study officials:
affiliation: Clinique des Fontaines
name: Michel BERCOVY, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04725201: Prospective Study on the Role of Intravenous Unfractionated Heparin Following Digital Replantation and Revascularization
Official title: Prospective Study on the Role of Intravenous Unfractionated Heparin Following Digital Replantation and Revascularization
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Amputation; Traumatic, Hand
Keywords: Replantation
Revascularization
Unfractionated heparin
Finger
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
First posted: 2021-01-26
Enrollment: 188
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective randomized double-blinded clinical trial
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effectiveness of therapeutic dose intravenous heparin at improving replantation/revascularization success and its indications (if any) in participants who have suffered traumatic digital amputation. Digital replantation/revascularization success will be assessed in participants who receive continuous intravenous drip of thromboprophylactic heparin at a therapeutic dose (i.e. modifies INR to the desired range) contrasted to those who do not receive therapeutic dose heparin (i.e. does not modify INR to the desired range). In the study, replantation/revascularization success is defined as a clearly viable digit at the time of discharge. Secondary objectives include assessing postoperative complications associated with heparin use, such as bleeding, hematoma or heparin induced thrombocytopenia. The investigators would also assess the impact of categorical variables such as smoking status, mechanism of injury and comorbidities, on digital survival.


Eligibility criteria: Inclusion Criteria:

* All replantation and revascularization patients who are accepted into the CEVARMU program at the Centre hospitalier de l'Université de Montréal

Exclusion Criteria:

* Patients on anticoagulants, other than ASA, prior to admission (i.e. Coumadin, Eliquis, Pradaxa, Plavix, or similar medications)
* Patients with a contraindication for heparin (e.g. coagulopathy, acute ulcers, thrombocytopenia, severe liver damage, shock)
* Patients who suffered an amputation in the level of the carpal tunnel and proximal to it
* Patients who experienced a degloving injury

Primary outcomes:
measure: Success of digit replantation or revascularization
timeFrame: Up to 14 days
Secondary outcomes:
measure: Heparin-related complications
timeFrame: Up to 14 days
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: CHUM
state: Quebec
Study officials:
affiliation: Université de Montréal
name: Bruno Mastropasqua, MD FRCSC
role: PRINCIPAL_INVESTIGATOR
References: