louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03838536: Synergistic Activity of Human Milk Nutrients and Infant Cognition
Official title: Synergistic Activity of Choline, Lutein, and Docosahexaenoic Acid in Human Milk in Support of Cognitive Development: An Egg Intervention Feasibility Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breastfeeding, Exclusive
Keywords: Breastfeeding
Eggs
Baby
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Egg Nutrition Center
First posted: 2019-02-12
Enrollment: 84
Sex: ALL
Minimum age (years): 3
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to whole egg or egg white powder to consume throughout the study.
Primary purpose: BASIC_SCIENCE

Brief summary: Purpose: To establish a whole food, egg, as a viable study material to supplement mothers and infants with nutrients that support optimal brain development. There will be 84 breastfeeding dyads, 3 months postnatal.

Mothers will be randomized to a whole egg or egg white (due to lack of an appropriate control food). Initial diet intake will be screened using the NDSR. Participants will come to the lab 3 times across 3 months (age 3 months, 4.5 months, and 6 months). Milk, saliva, and plasma will be collected from the mother, while saliva and plasma (heel stick) are collected from the infant. Diet data will be collected at each visit. The infant will complete a recognition memory test using electrophysiology at 6 months as well as the Bayley Scales of Infant Development at 4.5 months. The mother will complete a temperament questionnaire at 3 months and 6 months.


Eligibility criteria: Inclusion Criteria:

* infant is 12-15 weeks of age at enrollment
* healthy, lactating mother age 18-35
* gave birth at \>38 weeks gestation without remarkable incident
* consuming \<=50% of the recommended amounts of 2 of the 3, DHA, choline, and lutein

Exclusion Criteria:

* infant with diagnosis or documented suspicion of developmental delay
* egg allergy or family history of egg allergy
* gestational diabetes
* any documented seizure activity

Primary outcomes:
measure: Recognition Memory in an Oddball Task
timeFrame: 13 weeks (at 6 months of age)
Secondary outcomes:
Other outcomes:
measure: Bayley Scales of Infant Development (BSID)
timeFrame: 6 weeks (at 4.5 months of age)
Locations:
city: Kannapolis
country: United States
facility: Nutrition Research Institute
state: North Carolina
Study officials:
affiliation: Associate Professor, University of North Carolina-Chapel Hill
name: Carol L Cheatham, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02292836: Rosacea Prevalence in General Population - Pilot Study
Official title: Rosacea Prevalence in General Population - Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rosacea
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2014-11-17
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Rosacea and non-rosacea patients

Brief summary: The purpose of this study is to test and refine, a subject questionnaire aimed to be used in a general population rosacea prevalence study.

Detailed description: The study will test the subject questionnaire aimed to be used in a full general population prevalence study to screen potential subjects with rosacea.

Questionnaire will be self-administrated to Dermatology outpatients.

Testing will be performed at the practice of 2 Dermatologists experts in rosacea who will evaluate subjects' answers and propose fine-tuning of the questionnaire content, if needed.

Eligibility criteria: * Male or Female aged between 18 (or locally accepted majority) and 65 years old both included.
* Subject visiting one of the study dermatology practices for daily care/routine dermatology consultation.
* Subject have to read and sign the approved Informed Consent form prior to any participation in the study,
* Subject willing and capable of cooperating to the extend and degree required by the protocol

Primary outcomes:
measure: sensitivity and specificity of questions
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Windsor
country: Canada
facility: Jerry TAN
state: Ontario
city: Eskilstuna
country: Sweden
facility: Mats BERG
Study officials:
affiliation: Galderma R&D
name: Fabien AUDIBERT, Bsc
role: STUDY_DIRECTOR
References:
Clinical trial NCT06520436: Arthroscopic-Assisted Reduction of Hip Dislocation Via Sub-Adductor and Anterolateral Portals
Official title: Arthroscopic-Assisted Reduction for Developmental Dislocation of The Hip Through the Sub-Adductor and Anterolateral Portals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Developmental Dysplasia of the Hip
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-07-25
Enrollment: 57
Sex: ALL
Minimum age (years): 6
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study aims to present our arthroscopic-assisted surgical technique's reliability as a successful treatment for DDH, achieving reduction without the potential sequelae associated with open reduction techniques.

Detailed description: Developmental dysplasia of the hip (DDH) encompasses a spectrum of pathological conditions including dislocation, subluxation, and deformities of the femoral head and acetabulum. The optimal surgical approach for DDH remains a subject of debate. The goal of successful treatment is achieving a stable concentric reduction and preventing future subluxation or dislocation.The aim of this study is to introduce the reliability of our arthroscopic-assisted surgical technique as a successful treatment for DDH that can achieve reduction with avoidance of sequelae which may be experienced following open reduction techniques.

Eligibility criteria: Inclusion Criteria:

- Patients with DDH in this study

Exclusion Criteria:

- Previous surgical treatment and those with teratologic or neuromuscular dislocations

Primary outcomes:
measure: Acetabular index
timeFrame: 1 year
measure: Severin radiographic grading
timeFrame: 1 year
measure: Modified Severin clinical grading
timeFrame: 1 year
measure: Postoperative complications
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr Alainy, Cairo University
Study officials:
References:
Clinical trial NCT02385136: Temozolomide and Concomitant Whole Brain Radiotherapy in NSCLC Patients With Brain Metastases
Official title: Temozolomide and Concomitant Whole Brain Radiotherapy in NSCLC Patients With Brain Metastases: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: NSCLC
Keywords: NSCLC
Radiotherpy
Temozolomide
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
Collaborators: name: Hangzhou Cancer Hospital
First posted: 2015-03-11
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the safety profile and efficacy of whole brain radiotherapy (WBRT) concomitantly with temozolomide (TMZ) in patients with brain metastases (BM).Patients with BM were randomly assigned to 30 Gy of WBRT with or without concomitant TMZ (75 mg/m2/d) plus two cycles of TMZ (200 mg/m2/d for 5 days).


Eligibility criteria: Inclusion Criteria:

* histologically diagnosed as NSCLC, stage IVb \[ (American Joint of Cancer Committee(AJCC), 2002) \], Brain metastasis
* no history of hypertension or diabetes.

Exclusion Criteria:

* the brain tumor diameter \>5cm; RPA class =3; pregnancy.

Primary outcomes:
measure: objective response rate
timeFrame: 1 month post procedure
measure: Time to central nervous system progress which was confirmed by MRI
timeFrame: 1 to 24 months post procedure
Secondary outcomes:
measure: The Quality of Life
timeFrame: 0 to 24 months post procedure
measure: Overall Survival
timeFrame: 1 to 24 months post procedure
measure: Toxicity as measured by CTCAE V4.0
timeFrame: 0 to 24 months post procedure
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02829736: ThOracoscopic Wedge Resection Treated With Chest Tube Removal Intraoperatively
Official title: Pain and Reasons for Hospitalization in Patients Treated Without Post-operative Chest Tube After Thoracoscopic Wedge Resection - A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain
Decreased Lung Function
Delayed Discharge
Keywords: lung neoplasm
lung metastasis
enhanced recovery after surgery
fast-track surgery
intraoperative chest tube removal
pain
lung function
reasons for admission
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2016-07-12
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Chest tubes are used routinely although preliminary studies demonstrate the feasibility and safety of intraoperative chest drain removal. Previous studies are however either retrospective or mainly concerning benign disease.

Hypothesis: Participants treated without post-operative chest tube after thoracoscopic wedge resection have less pain, better pulmonary function and similar complication profile than participants treated with standard post-operative chest tube, and could possibly be discharged earlier.


Eligibility criteria: Inclusion Criteria:

* Elective thoracoscopic wedge resection
* Speaks and understands Danish
* FEV1 \>= 60% of expected

Exclusion Criteria:

* Increased risk of air leak evaluated by surgeon (large adhesions, bullae, emphysema, deep resection, etc.)
* Increased risk of bleeding evaluated by surgeon (high INR, anticoagulation not paused, large bleeding, etc.)
* Air leak on intraoperative sealing test
* Patients previously included in study
* Planned intraoperative frozen section with possible lobectomy
* Previously included in current study
* Planned frozen section diagnostics
* Previous ipsilateral anatomic lung resection

Primary outcomes:
measure: Pain
timeFrame: Through post-operative admission, an average of 1 day.
Secondary outcomes:
measure: Reasons for post-operative admission
timeFrame: Through post-operative admission, an average of 1 day.
measure: Lung function
timeFrame: Up to post-operative day 1.
measure: Reinsertion of chest tubes
timeFrame: Up to post-operative day 30.
measure: Pneumothorax
timeFrame: Up to post-operative day 1.
measure: Complications
timeFrame: Up to post-operative day 30.
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
affiliation: Rigshospitalet, Denmark
name: Henrik J. Hansen, MD
role: STUDY_DIRECTOR
affiliation: Rigshospitalet, Denmark
name: René H. Petersen, MD
role: STUDY_DIRECTOR
affiliation: Rigshospitalet, Denmark
name: Henrik Kehlet, DMSc
role: STUDY_DIRECTOR
affiliation: Rigshospitalet, Denmark
name: Bo L. Holbek, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05943236: Assessment of the Ankle Joint Axis Using a Long Ankle View Radiograph
Official title: Assessment of the Ankle Joint Axis Using a Long Ankle View Radiograph
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: X-ray
Lead sponsor: Mein Fusszentrum AG
Sponsor class: OTHER
Collaborators: name: Basel Academy for Quality and Research in Medicine
name: Merian Iselin Klinik
First posted: 2023-07-13
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Clinical indication for a radiographic assessment of the lower half of one leg

Brief summary: The study is a reliability (reproducibility) study on a single measurement procedure. Reliability (reproducibility) will be assessed by repeating the whole measurement procedure twice. The measurement procedure studied is the generation of a long ankle view image based on a radiographic assessment followed by a manual assessment of the medial-distal tibial angle.

Detailed description: The study is a reliability (reproducibility) study on a single measurement procedure. Reliability (reproducibility) will be assessed by repeating the whole measurement procedure twice. The measurement procedure studied is the generation of a long ankle view image based on a radiographic assessment followed by a manual assessment of the medial-distal tibial angle (MDTA).

In order to assess the value of different assessment methods of the MDTA, several variants will be considered, which are all applied to the same long ankle view image. To determine the intra- and interrater reliability of the manual assessment, this assessment will be done twice by different observers (one doctoral student, one radiologist) and repeated within each observer.

Eligibility criteria: Inclusion

* Clinical indication for a radiographic assessment of the lower half of one leg
* Age above 20

Exclusion Criteria:

* Previous bony procedures (surgery), fractures or anomalies of the lower leg, which does not allow a reliable assessment of the MDTA
* Symptomatic or clinically obvious malalignment at any level of the lower extremity
* Pregnancy

Primary outcomes:
measure: medial-distal tibial angle
timeFrame: Day 1 (There is only one single day of contact for each patient)
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Praxis "Meim Fusszentrum"
Study officials:
affiliation: Praxis "Mein Fusszentrum"
name: Markus Knupp, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04753736: Immunophenotypage of RIF and RM Patients and Intrauterine Administration of PBMC
Official title: Intrauterine Administration and Immunophenotyping of Autologous Peripheral Blood Mononuclear Cells in Patients With Repeated Implantation Failures During Undergoing in Vitro Fertilization Treatment
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Infertility, Female
Lead sponsor: Fertilys
Sponsor class: INDUSTRY
Collaborators: name: Centre hospitalier de l'Université de Montréal (CHUM)
First posted: 2021-02-15
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to identify a systemic immunological profile specific to patients with recurrent implantation failures (RIF) or miscarriages (RM) through blood immunophenotyping on the day of ovulation. This study also aims to determine whether the intrauterine administration of 5 million peripheral blood monocluear cells increases implantation and pregnancy rates in patients with RIF and decreases the risk of miscarriages in patients with RM, compared to what has already been published in the scientific literature


Eligibility criteria: Inclusion Criteria:

* All women aged 18 and over undergoing an IVF cycle with her partner's sperm at the Fertilys fertility center, without a RIF status, agreeing to participate in the study and having signed the consent form to participate in the study.
* All women aged 18 and over undergoing an IVF cycle with her partner's sperm at the Fertilys fertility center, with a RIF or RM status, agreeing to participate in the study and having signed the consent form to participate in the study.

Exclusion Criteria:

* Women who need a gametes donor (eggs and / or sperm).
* Women undergoing an IVF cycle with frozen sperm.
* Women with autoimmune disease.
* Women with diabetes.
* Women with a history of chemotherapy treatment.

Primary outcomes:
measure: Embryo implantation rate (biochemical pregnancy)
timeFrame: Two weeks following embryo transfer or 3 weeks following intrauterine insemination
measure: Clinical pregnancy rate
timeFrame: Six to 8 weeks of gestation
Secondary outcomes:
measure: Peripheral blood mononuclear cells populations (PBMC) distribution at Day 0
timeFrame: The day 0 of the patient's ovulation
measure: Peripheral blood mononuclear cells populations distribution at Day 2
timeFrame: After 48 hours of culture
measure: Cytokines (LIF, IL-6, IL-10, TNFα, FGF-2, VEGF, IL-8) quantification by ELISA in PBMC culture medium at Day 2
timeFrame: After 48 hours of culture
Other outcomes:
Locations:
city: Laval
country: Canada
facility: Fertilys
state: Quebec
Study officials:
References:
Clinical trial NCT03920436: Effects of Oral Ingestion of Drinking Water Using a Tumbler That Emits Far Infrared Rays on Metabolic Profile
Official title: Effects of Oral Ingestion of Drinking Water Using a Tumbler That Emits Far Infrared Rays at Room Temperature on Metabolic Profile in Adults: a RCT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Problems
Lead sponsor: Pusan National University Yangsan Hospital
Sponsor class: OTHER
First posted: 2019-04-18
Enrollment: 30
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of oral ingestion of drinking water using a tumbler that emits far infrared rays at room temperature on metabolic profile in adults for 8 weeks.

Detailed description: The investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of oral ingestion of drinking water using a tumbler that emits far infrared rays at room temperature on metabolic profile in adults for 8 weeks; the safety of the compound are also evaluate. The Investigators examine lipid profile, glucose, liver and renal function at baseline, as well as after 4, 8 weeks of intervention. Thirty adults were administered either 1.8 L of drinking water using a tumbler that emits far infrared rays at room temperature or drinking water using a sham-tumbler each day for 12 weeks.

Eligibility criteria: Inclusion Criteria:

* 19 years and older

Exclusion Criteria:

* aspartate aminotransferase (AST) or alanine aminotransferase (ALT) more than twice the highest reference value
* serum creatinine ≥ 1.5 mg/dL)
* uncontrolled diabetes mellitus (a fasting glucose of \>160 mg/dL)
* uncontrolled hypertension (BP \> 160/100 mmHg)
* severe gastrointestinal symptoms
* alcohol abuser
* pregnant or lactating women
* allergic to the ingredient involved
* cardiocebrovascular diseases or any cancer during the six months prior to study
* smoker

Primary outcomes:
measure: Low density lipoprotein cholesterol (LDL-C)
timeFrame: Change from baseline level of LDL-C at 8 weeks
Secondary outcomes:
measure: aspartate transaminase (AST)
timeFrame: Change from baseline level of AST at 8 weeks
measure: creatinine
timeFrame: Change from baseline level of creatinine at 8 weeks
measure: homeostasis model assessment of insulin resistance (HOMA-IR)
timeFrame: Change from baseline level of HOMA-IR at 8 weeks
measure: body weight
timeFrame: Change from baseline level at 8 weeks
measure: free fatty acid
timeFrame: Change from baseline level at 8 weeks
measure: alanine transaminase (ALT)
timeFrame: Change from baseline level of ALT at 8 weeks
Other outcomes:
Locations:
city: Yangsan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
state: Gyeungsangnam-do
Study officials:
affiliation: Pusan National University Yangsan Hospital
name: Sang Yeoup Lee
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05988736: Comparison Between McGrath and Macintosh Laryngoscopes for DLT Intubation in Thoracic Surgery Patients.
Official title: Comparison Between McGrath and Macintosh Laryngoscopes for Double-lumen Tube Intubation in Patients Undergoing Thoracic Surgery, A Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Thoracic Diseases
Thoracic Neoplasms
Thoracic Empyema
Lead sponsor: Aga Khan University
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 84
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: OTHER

Brief summary: The goal of this RCT is to compare outcome with McGrath vs Macintosh laryngoscopes among patients undergoing thoracic surgery. The main questions it aims to answer are,

1. Rate of successful intubation at first attempt and
2. Time for intubation required with each device. Participants are required to sign the informed consent for, they will be placed in two groups, Group A: Macintosh (DL) Group B: McGrath (VL) Researchers will compare in Group A: Macintosh (DL) and Group B: McGrath (VL) the differences in rate of successful intubation at first attempt and time for intubation required with each device.


Eligibility criteria: Inclusion Criteria:

* Age 18-65 years
* American Society of Anaesthesiologists physical status (ASA) I, II, III
* Elective thoracic surgery patients, requiring one lung ventilation.

Exclusion Criteria:

* Patients requiring rapid sequence induction
* Patients with a structural problem in the airway on chest radiography
* History of difficult intubation
* Planned tracheostomy \\ the presence of a tracheostomy

  * Patients with a BMI \>35 kg\\m2. Who at risk of regurgitation\\ Aspiration
  * Anticipated Difficult Airway (Mallampati IV)
  * Pre-existing sore throat or hoarseness, or recent respiratory infection (\<15 days)

Primary outcomes:
measure: Time required for correct placement of the Double Lumen Tube (DLT).
timeFrame: During intervention time period
measure: Successful Intubation at first attempt.
timeFrame: immediately after Intervention.
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Aga Khan University Hospital
state: Sindh
Study officials:
References: