louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03831126: Stress and Fetal Brain Development
Official title: The Impact of Stress on Fetal Brain Development
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pregnancy
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2019-02-05
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant women

Brief summary: The current proposal aims to investigate the impact of acute stress on the fetal autonomic nervous system.

Detailed description: Over the last decades there is growing evidence that increased maternal stress levels lead to an adverse effect on the physiological, metabolic and neuronal development of the fetus during gestation with possible long-lasting effects. Several studies showed that maternal stress also affects fetal endocrine processes during pregnancy and increases the risk for childhood and adult obesity. Thus, the aim of the study is to investigate the effect of acute stress related to the action of the artificial glucocorticoid betamethasone on fetal heart and brain activity. The fetal activity will be measured with biomagnetic sensors.

Eligibility criteria: Inclusion Criteria:

* German speakers (fluently)
* Gestational age between 28 and 34 weeks
* Treatment with Betamethasone for improvement of fetal lung function -

Exclusion Criteria:

* Smoking (regularly)
* Alcohol and drug consumption during pregnancy
* Congenital fetal disorders
* Women with bed rest
* acute depression or other psychiatric disorder (self report)

Primary outcomes:
measure: fetal and maternal heart rate
timeFrame: 8 weeks
Secondary outcomes:
measure: fetal and neonatal brain activity in response to auditory and visual stimuli
timeFrame: 8 weeks
Other outcomes:
measure: blood sugar levels
timeFrame: 8 weeks
Locations:
city: Tuebingen
country: Germany
facility: University Hospital Tuebingen, Department of Women's Health
Study officials:
References:
Clinical trial NCT02592226: Clinical Significance of Alveolar Recruitment Maneuver During Bariatric Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2015-10-30
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The ventilation of the patient under general anesthesia is an old problem and extensively studied, especially in visceral surgery, higher risk of postoperative complications. Studies have recently shown the impact of a lung-protective ventilation in visceral surgery, however obese patients are often excluded, and alveolar recruitment maneuver has never been studied independently.

The investigators are conducting a randomized controlled prospective study to investigate the clinical value to achieve alveolar recruitment maneuver routinely in patients undergoing bariatric surgery.

The objective is to show the reduction in dyspnea, oxygen dependency: reflection of atelectasis and the incidence of postoperative complications.


Eligibility criteria: Inclusion Criteria:

* Patients surgery for bariatric surgery (sleeve, gastric bypass, gastric banding ablation)
* planned surgery,
* ASA 1-2-3,

Exclusion Criteria:

* Severe COPD
* Severe emphysema,
* Pneumothorax,
* Right sided heart failure,
* Severe heart failure
* Emergency surgery,
* ASA 4

Primary outcomes:
measure: occurrence of dyspnea
timeFrame: 2 hours
measure: oxygen saturation
timeFrame: 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de Nice
Study officials:
affiliation: Centre Hospitalier Universitaire de Nice
name: Mathilde SEVERAC, Dr
role: STUDY_DIRECTOR
References:
citation: Severac M, Chiali W, Severac F, Perus O, Orban JC, Iannelli A, Debs T, Gugenheim J, Raucoules-Aime M. Alveolar recruitment manoeuvre results in improved pulmonary function in obese patients undergoing bariatric surgery: a randomised trial. Anaesth Crit Care Pain Med. 2021 Jun;40(3):100775. doi: 10.1016/j.accpm.2020.09.011. Epub 2020 Nov 1.
Clinical trial NCT00791726: Microperimetry in Macular Edema
Official title: Place of Fundus-related Microperimetry in Uveitic Macular Edema
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Macular Edema
Uveitis
Keywords: microperimetry
macular edema
uveitis
Retinal sensitivity as measured with fundus related microperimetry
Lead sponsor: St. Franziskus Hospital
Sponsor class: OTHER
First posted: 2008-11-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with noninfectious uveitis, macular edema

Brief summary: In uveitic patients with fluorescein angiographically proven macular edema, a fundus related microperimetry is performed and results are correlated with foveal thickness as measured with optical coherence tomography (OCT).


Eligibility criteria: Inclusion Criteria:

* Patients with noninfectious uveitis, macular edema

Exclusion Criteria:

* Pregnancy, fluorescein allergy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Muenster
country: Germany
facility: Department of Ophthalmology at St Franziskus Hospital
state: Northrhine-Westfalia
Study officials:
References:
citation: Roesel M, Heimes B, Heinz C, Henschel A, Spital G, Heiligenhaus A. Comparison of retinal thickness and fundus-related microperimetry with visual acuity in uveitic macular oedema. Acta Ophthalmol. 2011 Sep;89(6):533-7. doi: 10.1111/j.1755-3768.2009.01750.x. Epub 2009 Dec 9.
Clinical trial NCT01471626: Real-time Attended Home-polysomnography Through Telematic Data Transmission
Official title: Real-time Attended Home-polysomnography Through Telematic Data Transmission
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Keywords: sleep apnea
polysomnography
telemedicine
Lead sponsor: Centre Hospitalier Universitaire Saint Pierre
Sponsor class: OTHER
First posted: 2011-11-15
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to develop an efficient home-based polysomnography device, which allows, through GPRS,continuous real-time monitoring from the sleep lab based in the hospital, in order to decrease the failure rate of home-based recordings.


Eligibility criteria: Inclusion Criteria:

* clinical suspicion of OSA
* 18 y old

Exclusion Criteria:

* restrictive respiratory disorders
* distance home-hospital exceeding 30 Km.

Primary outcomes:
measure: Quality of Polysomnographic Recordings
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: CHU St Pierre
Study officials:
affiliation: CHU St Pierre
name: Marie Bruyneel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02055326: Yoga for Men Attempting Smoking Cessation
Official title: Complementary Treatments for Smoking Cessation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Keywords: Smoking
yoga
men
intervention
Lead sponsor: The Miriam Hospital
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2014-02-05
Enrollment: 38
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this pilot study is to examine the feasibility and preliminary efficacy of a quit-smoking program that combines behavioral therapy with either yoga, or a health \& wellness program that serves as a contact control.

Detailed description: Men enrolled in this pilot will be provided with 8 weeks of cognitive-behavioral therapy for smoking cessation and either 1) a twice-weekly program of yoga, or 2) a health \& wellness program that serves as a control for number of contacts and subject burden between study conditions. Qualitative data from open ended surveys and interviews is used to supplement survey data to enhance the investigators understanding of study outcomes. Participant accrual and retention rates, acceptance of randomization, and compliance with study protocols will be examined along with perceptions and beliefs about yoga and its relationship to quitting smoking specifically, and health in general.

Eligibility criteria: Inclusion Criteria:

* male
* age 18 -65
* daily smoker, 5 or more cigarettes/day
* generally healthy
* able to exercise safely

Exclusion Criteria:

* female
* hypertension
* current or recent history of medication use for major depression
* participation in yoga classes within the past year
* current or \>1 year prior experience with mind/body therapies
* currently participating in regular exercise classes
* currently enrolled in quit smoking program
* currently using quit smoking medications

Primary outcomes:
measure: Smoking abstinence
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Providence
country: United States
facility: The Miriam Hospital
state: Rhode Island
Study officials:
References:
citation: Jackson S, Brown J, Norris E, Livingstone-Banks J, Hayes E, Lindson N. Mindfulness for smoking cessation. Cochrane Database Syst Rev. 2022 Apr 14;4(4):CD013696. doi: 10.1002/14651858.CD013696.pub2.
Clinical trial NCT00033826: Role of Fat Tissue in Vitamin D Metabolism
Official title: The Role of Adipose Tissue in Vitamin D Metabolism
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vitamin D
Adipose Tissue
Keywords: Vitamin D
Adipose tissue
Metabolism
Lead sponsor: Tufts University
Sponsor class: OTHER
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2002-04-11
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients from Obesity Clinic

Brief summary: Vitamin D is a fat soluble vitamin that has important effects on calcium (including absorption of calcium from the diet) and bone metabolism. Vitamin D is known to be stored in fat tissue, and it is also present in the circulation. The purpose of this study is to investigate the relationship between levels of vitamin D in fat tissue and in blood.

Detailed description: Although vitamin D is known to be stored in fat tissue, researchers are not sure about the role that fat tissue plays in vitamin D metabolism. This study will help develop the methodology necessary to further investigate the role of fat tissue in vitamin D metabolism and will assess the relationship between levels of vitamin D in fat tissue and in blood. 50 subjects who are referred for gastric bypass surgery will be enrolled in this study. Subjects will complete questionnaires about their medical history, travel history and food intake. Prior to or during surgery, subjects will be asked to provide a blood sample for selected chemistries related to vitamin D metabolism. During gastric bypass surgery, the surgeon will collect small pieces of fat tissue from the fat under the skin and within the abdomen by surgical biopsy. These samples will be used to refine the methodology for determining the levels of vitamin D in blood and fat tissue and for comparing levels of vitamin D in various tissues.

Eligibility criteria: Inclusion Criteria:

* Obese patients referred for gastric bypass surgery

Exclusion Criteria:

* Patients must not be taking bile acid-sequestering medications or anti-seizure medications

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Tufts-New England Medical Center
state: Massachusetts
Study officials:
affiliation: Jean Mayer USDA Human Nutrition Center on Aging at Tufts University
name: Miriam Blum, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01149226: Effects of Chloral Hydrate on Induction, Maintenance, and Recovery From Sevoflurane Anesthesia in Day-case Pediatric Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric
Keywords: pediatric patients
ASA physical status I or II
aged between 1-5 yrs
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2010-06-28
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Effects of Choral Hydrate on Induction, Maintenance, and Recovery from Sevoflurane Anesthesia in Day-case Pediatric Surgery


Eligibility criteria: Inclusion Criteria:

1. ASA I or II
2. 1-5 years children
3. elective day-case orchiopexy

Exclusion Criteria:

1. congenital hear disease
2. renal disease
3. liver disease
4. growth retardation
5. coagulopathy

Primary outcomes:
measure: Preoperative Anxiety
measure: Induction Compliance
measure: Postoperative Pain
measure: Posthospitalization Behavior
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
References:
Clinical trial NCT03955926: Ultrasonographic Assessment of Stomach in Two Different Fasting Guidelines
Official title: Ultrasonographic Assessment of Stomach for Comparison of Antral Cross-sectional Area in Two Different Fasting Guidelines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: General Anesthesia
Lead sponsor: Kangbuk Samsung Hospital
Sponsor class: OTHER
First posted: 2019-05-20
Enrollment: 64
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Oral carbohydrate loading until 2 h before surgery is well known to be effective in facilitating postoperative recovery and reducing complications, by maintaining homeostasis. However, there are still concerns in implementing this as a universal fasting guideline, because of the risk of pulmonary aspiration. Therefore, we designed this study to compare the two preoperative fasting guideline: (1) keep fasted from midnight until surgery, and (2) oral carbohydrate beverage 800 mL from midnight until 2 h before surgery.


Eligibility criteria: Inclusion Criteria:

* adult aged from 18 to 70
* American Society of Anesthesiologists (ASA) class I or II
* absence of pregnancy
* not on lactation at the time of surgery

Exclusion Criteria:

* delayed gastric emptying (GERD, gastrointestinal disease, diabetes)
* contraindicated to NSAID or opioid
* mental disorders
* alcoholism
* drug abuse

Primary outcomes:
measure: Cross-sectional area of gastric antrum
timeFrame: 1 hour before surgery
Secondary outcomes:
measure: Hunger score
timeFrame: 1 hour before surgery
measure: Thirst score
timeFrame: 1 hour before surgery
measure: Preoperative anxiety
timeFrame: 1 hour before surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
Study officials:
affiliation: KangbukSamsung Hospital
name: Eunah Cho, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cho EA, Huh J, Lee SH, Ryu KH, Shim JG, Cha YB, Kim MS, Song T. Gastric Ultrasound Assessing Gastric Emptying of Preoperative Carbohydrate Drinks: A Randomized Controlled Noninferiority Study. Anesth Analg. 2021 Sep 1;133(3):690-697. doi: 10.1213/ANE.0000000000005411.
Clinical trial NCT02736526: Study of Surgical Treatment Versus Observation in Children With Moderate Intermittent Exotropia
Official title: Long-term Prospective Randomized Controlled Clinical Study on Surgical Treatment of Moderate Intermittent Exotropia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Moderate Intermittent Exotropia
Keywords: moderate intermittent exotropia
surgical treatment
observation
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2016-04-13
Enrollment: 280
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the long-term effect and security of the surgical treatment and observation only on ocular alignment, binocular stereopsis, and quality of life in children with moderate intermittent exotropia.


Eligibility criteria: Inclusion Criteria:

1. To correspond the definition of IXT: monocular or binocular alternative exotropia, exodeviation at distance for 15 prism diopters at least, can control the normal ocular alignment, normal ocular movements.
2. Simultaneous perception and fusion point in synoptophore, but no normal function of fusion and stereopsis.
3. Age at from 5 to 18 years, sex unlimited.
4. No treatment for IXT previously (including surgical and non-surgical treatment).
5. No amblyopia.
6. Signed informed consent form voluntarily.

Exclusion Criteria:

1. Accompanied with ocular organic diseases.
2. Accompanied with systemic diseases (e.g. nervous system disease).
3. Unable to regular follow-up (e.g. from countryside and outlying district).
4. Investigators concluded that should be excluded.

Primary outcomes:
measure: Ocular alignment (Prism alternative cover test)
timeFrame: 5 years
measure: Binocular stereopsis at distance and near (Random dot stereopsis test)
timeFrame: 5 years
Secondary outcomes:
measure: Newcastle control scores
timeFrame: 5 years
measure: The intermittent exotropia questionnaire
timeFrame: 5 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center, Sun Yat-sen University
state: Guangdong
Study officials:
References:
Clinical trial NCT05922826: Clinical Empirical Research of ARDS
Official title: Clinical Empirical Research of ARDS
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Invasive Mechanical Ventilation ARDS
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2023-06-28
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: According to the ARDS Berlin definition, patients with severe concurrent invasive mechanical ventilation were selected, and clinical data and prognosis were collected. Samples such as blood and balf were collected for analysis based on changes in the condition.

Brief summary: According to the ARDS Berlin definition, patients with severe concurrent invasive mechanical ventilation were selected, and clinical data and prognosis were collected. Samples such as blood and balf were collected for analysis based on changes in the condition.


Eligibility criteria: Inclusion Criteria:

1. Patients who meet the Berlin definition of ARDS and require invasive mechanical ventilation. ARDS diagnostic criteria: according to the Berlin definition, Chest radiograph shows patchy shadows in the lungs; Respiratory failure cannot be completely caused by heart failure or excessive fluid infusion
2. ARDS onset ≤ 3 days when included in the study
3. Patient PaO2/FiO2 ≤ 200mmHg when included in the study

Exclusion Criteria:

* 1) Patients with intracranial hypertension, pleural fistula, pneumothorax, HIV, HBV, HCV

  2) Age\>85 years old or\<18 years old

  3) Pregnant patients

  4) Severe hemodynamic instability (vasopressor increase\>30% in the first 6 hours, or Norepinephrine\>0.5 mg kg/min)

  5) Patients unable to perform EIT ventilation and/or perfusion testing (unable to perform internal jugular vein catheterization, Hypernatremia, chest malformation, active implant device, unstable spinal injury or fracture, skin lesions opposite the EIT monitoring area)

  6) Patients with abnormal esophageal anatomical structure and inability to indwelling gastric tubes

  7) Disagreement for inclusion in this study

Primary outcomes:
measure: Overall Survival
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Pulmonary and Critical Care Medicine, Chinese PLA General Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT06134726: Temporomandibular Joint in Patients With Rheumatoid Arthritis
Official title: Temporomandibular Joint in Patients With Rheumatoid Arthritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Temporomandibular Joint Disorders
Rheumatoid Arthritis
Keywords: Rheumatoid arthritis
Temporomandibular joints
Bruxism
Lead sponsor: Syrian Private University
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 142
Sex: ALL
Minimum age (years): 35
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 142 participants were recruited in two groups: 72 patients with Rheumatoid Arthritis (RA), and 70 healthy controls

Brief summary: the investigators study aimed to evaluate temporomandibular joint involvement in rheumatoid arthritis patients and healthy individuals 142 participants were recruited in two groups: 72 patients with Rheumatoid Arthritis (RA), and 70 healthy controls. All participants were tested for seropositivity of rheumatoid factor and anticitrullinated protein antibodies. TMD diagnosis was determined according to the standardized and validated diagnostic criteria for TMD (DC/TMD): myalgia, arthralgia, articular disc, displacement, degenerative joint disease, and headache attributed to TMD. Bruxism, a probable sleep and/or awake bruxism diagnosis was determined based on self-report and several clinical findings.


Eligibility criteria: * Inclusion criteria included:

  * age \> 18 years old
  * individuals who had a minimum of 12 natural teeth.
* Exclusion criteria

  * included: trauma or surgery on the jaw
  * facial nerve paralysis
  * tooth implant
  * scleroderma
  * cerebrovascular accident
  * schizophrenia
  * steroid injection within the last six months.

Primary outcomes:
measure: Number of patients with prevalence of TMD
timeFrame: 2 years
measure: Number of patients with TMD-pain diagnoses
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Damascus
country: Syrian Arab Republic
facility: Faculty of Medicine, Damascus University, Syria
Study officials:
References: