louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02223169: Human Intervention Study of Egg Protein Derivative on Cardiovascular Risk
Official title: Dietary Intervention Study to Assess the Effects of Albumin-Derived Peptides on Cardio-Metabolic Risk Factors in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: Blood Pressure
Hypertension
Cardiovascular disease
Lead sponsor: University College Cork
Sponsor class: OTHER
First posted: 2014-08-22
Enrollment: 69
Sex: ALL
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Heart disease and stroke are the most common cause of death in Ireland today.One of the main risk factors for heart disease and stroke is high blood pressure or hypertension. Research has found that certain specific proteins or peptides found in foods such as dairy, meat, fish and eggs may promote heart health reducing blood pressure in adults with hypertension. The aim of this study is to investigate the potential beneficial effects egg peptides may have on heart health, in particular, effects on blood pressure.

Detailed description: Poor dietary habits of Irish adults has been accompanied by epidemics of obesity and metabolic disorders such as type II diabetes leading to a substantial predicted increase in the prevalence of chronic diseases such as cardiovascular disease.Hypertension is a major contributing factor to the development of cardiovascular and metabolic diseases. Dietary factors play a significant role in the prevention and/or treatment of hypertension and therefore the development of foods with antihypertensive properties could prove beneficial.

Eligibility criteria: Inclusion Criteria:

* Male and female
* Non-diabetic
* Aged 50-65
* BMI 25-35kg/m²
* Mild hypertensive: Blood pressure 130-149 mmHg

Exclusion Criteria:

* Current smoker
* Diagnosed hypertensive
* History of cardiovascular disease
* Diabetic
* Chronic kidney disease
* Gastrointestinal disease
* Currently on anti-hypertensive medications
* Allergic to eggs

Primary outcomes:
measure: A change between baseline blood pressure and endpoint blood pressure within the intervention group vs control group.
timeFrame: 42 days
Secondary outcomes:
Other outcomes:
Locations:
city: Cork
country: Ireland
facility: School of Food and Nutritional Sciences, UCC
city: Cork
country: Ireland
facility: University College Cork
Study officials:
affiliation: University College Cork
name: Mairead Kiely, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00468169: Cetuximab (ERBITUX®) Added to Two Concurrent Chemoradiotherapy Platforms in Locally Advanced Head and Neck Cancer
Official title: A Randomized Phase II Trial of Concurrent Chemoradiation With Cetuximab (ERBITUX®), 5 Fluorouracil, Hydroxyurea, and Twice-daily Radiation (CetuxFHX) Versus Cetuximab (ERBITUX®), Cisplatin, and Accelerated Radiation With Concomitant Boost (CetuxPX) After Induction Chemotherapy in Patients With Locally Advanced Head and Neck Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Head and Neck Cancer
Keywords: Cetuximab
Erbitux
locally
advanced
head
neck
cancer
neoplasms
squamous
carcinoma
lymphoepithelioma
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: Bristol-Myers Squibb
First posted: 2007-05-02
Enrollment: 110
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: The main purpose of this study is to explore and compare the efficacy of Cetuximab (ERBITUX®) added to two concurrent chemoradiotherapy platforms of different intensity in locally advanced head and neck cancer.


Eligibility criteria: Inclusion Criteria:

* Age 18 or older
* Stage III and IV head and neck cancer
* Patients with squamous cell carcinoma of unknown primary and suspected origin in the head and neck area
* No prior chemotherapy or radiotherapy
* Prior surgical therapy of incisional or excisional biopsy and organ-sparing procedures only
* Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
* Normal organ and marrow function

Exclusion Criteria:

* Unequivocal demonstration of metastatic disease
* Known severe hypersensitivity to drugs used in the study
* Treatment with a non-approved or investigational drug within 30 days before Day 1
* Incomplete healing from previous surgery
* Pregnancy or breast feeding
* Uncontrolled intercurrent illness including
* Patients with clinically significant pulmonary dysfunction, cardiomyopathy, or any history of clinically significant CHF
* Acute hepatitis or known HIV
* Severe baseline neurologic deficits
* Prior therapy which specifically and directly targets the EGFR pathway
* Prior severe infusion reaction to a monoclonal antibody

Primary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: 1 years
measure: Progression Free Survival (PFS)
timeFrame: 2 years
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: 2 years
measure: Objective Response Rate to Induction
timeFrame: Post-Induction (8 weeks)
measure: Objective Response Rate to CRT
timeFrame: From date of chemoradiotherapy until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 10 weeks
measure: Residual Lymph Node Disease
timeFrame: Up to 10 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Everett E Vokes, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04923568: VR and Chronic Pain Pilot Usability Study
Official title: Virtual Reality and Chronic Pain Pilot Usability Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Lead sponsor: Albert Einstein College of Medicine
Sponsor class: OTHER
First posted: 2021-06-11
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This is a pilot feasibility and usability study of a virtual reality device for patients with chronic pain.

Detailed description: The investigators will conduct a study of patients with chronic pain to identify interest in participating in a large VR trial and, for those willing to join the team to test the device in person, to pilot 2 sessions of VR to assess usability and collect preliminary data on pain and mood and to obtain data on patient satisfaction with device use. Researchers expect the entire session to last 45 minutes to 1 hour.

All patients recruited will be in the active arm; this is not a randomized pilot study.

The intervention being piloted is the EaseVRx - AppliedVR, Los Angeles, CA - VR hardware and software. EaseVRx incorporates evidence-based principles of cognitive behavioral therapy, mindfulness, and pain neuroscience education into an immersive and enhanced biofeedback experience. EaseVRx includes breathing training and relaxation response exercises that activate the parasympathetic nervous system. EaseVRx was designed for at-home use and comes with a sequence of daily immersive experiences, with each VR experience being 2-16 minutes in length (average of 6 minutes). For this pilot, researchers will be doing one in-person session, using two interoceptive VR experiences (out of 56 total).

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years
2. Chronic pain (using self-report) with pain intensity \>=4 and confirmed by ICD-10 codes in medical record
3. Fluency in English

Exclusion Criteria:

1. Inability to give informed consent
2. Current or prior diagnosis of epilepsy, seizure disorder, dementia, migraines
3. Medical condition predisposing to nausea or dizziness
4. Hypersensitivity to flashing light or motion
5. No stereoscopic vision or severe hearing impairment
6. Injury to eyes, face, or neck that prevents use of VR headset
7. Currently pregnant, by self-report

Primary outcomes:
measure: % of participants contacted that are enrolled
timeFrame: at study 1 day visit
Secondary outcomes:
measure: Satisfaction with VR experience
timeFrame: at study 1 day visit
measure: Change in Mood
timeFrame: at study 1 day visit
measure: Change in Pain intensity
timeFrame: at study 1 day visit
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
Study officials:
affiliation: Albert Einstein College of Medicine
name: Hector R Perez, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05834868: Efficacy and Safety of THDB0206 Compared to Insulin Lispro Injection in Participants With Type 2 Diabetes
Official title: A Phase 3, Randomized, Open-Label, Multicenter, Active-controlled Trial Comparing Efficacy and Safety of THDB0206 Injection With Insulin Lispro Injection Combined With Insulin Glargine Injection U-100 in Chinese Participants With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Type 2 Diabetes
Lead sponsor: Tonghua Dongbao Pharmaceutical Co.,Ltd
Sponsor class: INDUSTRY
First posted: 2023-04-28
Enrollment: 805
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: TREATMENT

Brief summary: This is a 26-week randomized, open-label, multicenter, active-controlled parallel group trial. The purpose of this study is to compare efficacy and safety of THDB0206 injection with insulin lispro injection combined with insulin glargine injection U-100 in Chinese participants with T2DM.


Eligibility criteria: Inclusion Criteria:

* Body mass index: 18.0 kg/m\^2\~35.0 kg/m\^2 (both inclusive) at the time of screening.
* HbA1c: 7.0%\~10.0% (both inclusive) at the time of screening.
* Diagnosed with T2DM for 6 months or longer at the time of screening based on the World Health Organization (WHO) classification.
* Treated with stable insulin regimen as follow for at least 3 months with or without oral antidiabetic drug:

  1. Basal insulin (neutral protamine Hagedorn \[NPH\] insulin, insulin glargine, insulin degludec, insulin detemir) in combination with at least 1 prandial injection of bolus insulin.
  2. Premixed insulin at least twice daily.

Exclusion Criteria:

* Have other types of diabetes other than T2DM.
* Have used Glucagon-Like Peptide 1 (GLP-1) receptor agonist within 3 months prior to screening.
* Have had 1 or more episodes of severe hypoglycemia within the 6 months prior to screening.
* Have had 1 or more episodes of acute diabetic complications (diabetic ketoacidosis, hyperglycemic hyperosmolar state, diabetic lactic acidosis, etc.) within the 6 months prior to screening.
* With concomitant conditions at screening that may affect the evaluation of the study, including cardiovascular and cerebrovascular diseases, respiratory diseases, gastrointestinal diseases, liver diseases, kidney diseases, nervous system diseases, psychiatric diseases, hematological diseases, immune system diseases, endocrine system diseases, pancreatic diseases, and/or malignant tumors.

Primary outcomes:
measure: Change in Glycosylated Haemoglobin (HbA1c) After 26 Weeks of Treatment
timeFrame: Week 26
Secondary outcomes:
measure: Change From Baseline in 1-hour Postprandial Glucose (PPG) Excursion at Week 26
timeFrame: Week 26
measure: Change From Baseline in 2-hour Postprandial Glucose (PPG) Excursion at Week 26
timeFrame: Week 26
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital
Study officials:
References:
Clinical trial NCT02362568: Study of Interest on Cervical Ultrasound Exploration for Association With Difficult Intubation
Official title: Human Study of Interest on Cervical Ultrasound Exploration for Association With Criteria of Difficult Intubation in General Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intubation; Difficult
Keywords: Intubation; Difficult
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2015-02-13
Enrollment: 462
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 determine if cervical ultrasound exploration can predict difficult intubation better than main validated clinical criteria.

Detailed description: The purpose of this study is to determine if cervical ultrasound exploration can predict difficult intubation better than main validated clinical criteria in general surgery.

Eligibility criteria: Inclusion Criteria:

* Age over 18
* patient consent

Exclusion Criteria:

* patient nonconsent
* age under 18
* cervical surgery

Primary outcomes:
measure: Sensibility, Specificity, predictive positive and negative values of US cervical measures relationship between the hyoid bone and thyroid cartilage with difficult intubation
timeFrame: Day 1
Secondary outcomes:
measure: Sensibility, specificity and predictive positive and negative values of validated clinical criteria for difficult intubation
timeFrame: Day 1
measure: Mortality and morbidity of difficult intubation
timeFrame: Day 1
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHRU de Besançon
state: Franche Comte
city: Besancon
country: France
facility: CHU Besancon Minjoz
Study officials:
affiliation: Centre Hospitalier Universitaire de Besancon
name: Boinette Romain, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06776068: The Impact of Lumboscopy Versus Laparoscopy on Ventilatory Mechanics
Official title: Comparison of the Impact of Lumboscopy and Laparoscopy on Ventilatory Mechanics in Patients Undergoing Nephrectomy
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Anesthesia
Mechanical Ventilation
Respiratory Physiology
Keywords: Anesthesia
Lumboscopy
Mechanical Ventilation
Laparoscopy
Lead sponsor: University of Chile
Sponsor class: OTHER
First posted: 2025-01-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients undergoing general anesthesia for minimally invasive nephrectomy

Brief summary: There are several techniques for performing minimally invasive urological surgeries. Among them, laparoscopic surgery, robotic surgery, and lumboscopy are noteworthy (1). The medical literature extensively documents the impact of pneumoperitoneum a procedure involving the insufflation of the peritoneal cavity with carbon dioxide (CO2), which is essential for laparoscopic and robotic surgeries on ventilatory mechanics.

As an alternative, CO2 insufflation into the retroperitoneum, as utilized in lumboscopic surgery, has been proposed. This approach is believed to exert a lesser impact on respiratory function and pulmonary mechanics. However, it is important to note that no conclusive evidence has yet been found to support this claim.

Assessing the impact of lumboscopic surgery could help establish it as a viable alternative for patients with pulmonary conditions, where mechanical ventilation poses significant challenges. To explore this possibility, a physiological study was designed to compare the effects of laparoscopic and lumboscopic surgery on ventilatory mechanics.


Eligibility criteria: Inclusion Criteria:

* Age \>18 years old
* ASA PS II-III
* Elective surgery
* Surgery: Partial or total nephrectomy

Exclusion Criteria:

* Severe pulmonary pathology
* Severe cardiovascular pathology
* Open surgery

Primary outcomes:
measure: Parameters of ventilatory mechanics
timeFrame: intraoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Hospital Clínico Universidad de CHile
city: Santiago
country: Chile
facility: Instituto Nacional del Cáncer
Study officials:
References:
citation: Guillonneau B, Ballanger P, Lugagne PM, Valla JS, Vallancien G. Laparoscopic versus lumboscopic nephrectomy. Eur Urol. 1996;29(3):288-91. doi: 10.1159/000473762.
Clinical trial NCT02423668: Pseudophakic Anterior Chamber Depth Measurement in Second Eye Refinement Cataract Surgery
Official title: Pseudophakic Anterior Chamber Depth Measurement in Second Eye Refinement Cataract Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cataract
Keywords: cataract surgery
biometry
second eye refinement
effective lens position
Lead sponsor: Centro Hospitalar do Baixo Vouga
Sponsor class: OTHER
First posted: 2015-04-22
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients recruited from the electronic database of a single ophthalmological center as having performed bilateral cataract surgery between 1st June 2013 and 24th July 2014

Brief summary: To study the effective lens position concept in second eye refinement (SER) cataract surgery, by relating inter-ocular symmetry of pseudophakic anterior chamber depth (pACD) measured in Pentacam and SER refractive outcomes.

Detailed description: A retrospective chart review was conducted, including demographics (age and gender) and several parameters for both the first and second eyes, including the intra-ocular lens power calculation using the HofferQ, SRK/T and Holladay 1 formulas. Pentacam HR was used for pseudophakic anterior chamber depth measurement, and manual measurement was performed by a single investigator tracing a line between the anterior surface of the intra-ocular lens and the central corneal epithelium apex. Second eye refinement in the intra-ocular lens power selection for the second eye was performed using a theoretical 50% partial adjustment of the prediction error of the first eye. To relate refractive outcomes to pACD values, the investigators performed subgroup analysis based in consecutive 50µm increments in inter-ocular asymmetry of pACD (50-600).

Eligibility criteria: Inclusion Criteria:

* patients admitted for bilateral age-related cataract surgery

Exclusion Criteria:

* Age \< 18 years old
* Previous or combined ocular surgery
* Manual extracapsular cataract extraction and not phacoemulsification
* Corneal sutures
* Implantation of any other IOL type
* IOL implanted in the sulcus
* Intra or postoperative complication
* Post-operative best-corrected visual acuity worse than 5/10
* Anterior corneal astigmatism\>3.00 D
* Inadequate cooperation for Pentacam HR examination

Primary outcomes:
measure: Second eye mean absolute error
timeFrame: 4-6 weeks after second eye surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Centro Hospitalar Baixo Vouga
name: Pedro Gil, MSc, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05216068: Investigation and Diagnosis of the Chromosome Variation in Donated/abandoned Blastocyst
Official title: Investigation and Diagnosis of the Chromosome Variation in Donated/abandoned Blastocyst
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chromosome Translocation
Genetic Disorders in Pregnancy
Recurrent Miscarriage
Keywords: pre-implantation genetic diagnosis
balanced reciprocal translocation (BRT)
structural variation (SV)
next generation sequencing
abandoned blastocysts
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2022-01-31
Enrollment: 57
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Blastocysts derived from patients seeking infertility treatment were generated by in vitro fertilization and embryo culture as previously described, and were evaluated using the Gardner system. As part of the embryo selection process, cells of TE biopsy were collected, and blastocysts were vitrified. The clinical TE biopsies were subjected to whole genome amplification (WGA) with SurePlex reagents (Illumina) followed by NGS-based PGT-A using Illumina's VeriSeq kit (Illumina) on a MiSeq system (Illumina) according to the manufacturer's protocol.

Detailed description: Collected 200 donate abandonment embryos (well-developed blastocysts) for research under the National Assisted Reproduction Act of Taiwan.

1. Collected 200 donate abandonment embryos: Five to six days after egg retrieval, well-developed embryos (called blastocysts).
2. Blastocysts derived from patients seeking infertility treatment were generated.
3. Embryos biopsies for PGT-A (by use of NGS platforms from our institute) will be used for the validation of our Lab QC embryo.
4. To standardize the operating procedures
5. Paper writing.

Eligibility criteria: Inclusion Criteria:

* the surplus blastocysts
* parents consent to donate the embryos

Exclusion Criteria:

* not agree to participate in this program
* whose embryo morphology and quality do not meet the technical requirements for genetic testing

Primary outcomes:
measure: Blastocyst aneuploidy rate
timeFrame: 28 days
Secondary outcomes:
measure: Whole genome amplification rate
timeFrame: 7 days
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
References: