louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02602171: Virtual Acoustic Localization Experiment
Official title: Virtual Acoustic Localization Experiment for the Evaluation of a Dereverberation Algorithm in Terms of Speech Intelligibility & Localization Performance of Normal Hearing & Hearing Impaired Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2015-11-11
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The present study has the evaluation of a test to measure the localization performance goal . It is about the perception of danger audio signals in everyday listening environments nearby which are reproduced in controlled laboratory conditions. In addition, a dereverberation algorithm regarding speech intelligibility and localization ability is evaluated . The research hypothesis is that the dereverberation of the audio signals can improve speech intelligibility for both normal hearing and hearing-impaired persons. In addition, the binaural dereverberation algorithm should not affect the localization ability in everyday situations.


Eligibility criteria: Inclusion Criteria:

* adults , in general healthy (no diagnosis of dementia and/or stroke known), mother tongue: (swiss) german, normal hearing or with hearing aid wearers both sides or with CI support on both sides, symmetrical hearing loss

Exclusion Criteria:

* deviation of inclusion criteria, known fluctuating, rapidly progressive hearing loss, test person is not able to come one time a week to the University Hospital of Zurich or to handle 1-2 hours appointments or is not able to use touchscreen

Primary outcomes:
measure: Oldenburger sentence test and localization test with 30 subjects
timeFrame: 1 day
Secondary outcomes:
measure: Differences in localization ability
timeFrame: 1 day
Other outcomes:
Locations:
Study officials:
affiliation: University of Zurich
name: Norbert Dillier, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04667871: Effect of Cataract Hyperemulsification Surgery on Meibomian Gland Morphology and Function
Official title: Effect of Cataract Hyperemulsification Surgery on Meibomian Gland Morphology and Function
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Meibomian Gland Dysfunction
Keywords: meibomian gland
cataract surgery
Lead sponsor: Wenzhou Medical University
Sponsor class: OTHER
First posted: 2020-12-16
Enrollment: 0
Sex: ALL
Minimum age (years): 38
Maximum age (years): 87
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Those patients who undergoing cataract hyperemulsification surgery and previously untreated with xerophthalmia.

Brief summary: 50 participants at Eye Hospital of Wenzhou Medical University during August, 2017 to July, 2020 will be enrolled in this study. To study the effect of cataract supermammary surgery on the morphology and function of meibomian glands


Eligibility criteria: Inclusion Criteria:

* Previously untreated patients with xerophthalmia
* Undergoing cataract hyperemulsification surgery

Exclusion Criteria:

* No history of ocular surgery and trauma
* Any eye diseases except xerophthalmia
* No treated for xerophthalmia before
* Successful completion of follow-ups

Primary outcomes:
measure: OSDI scale survey
timeFrame: 08/2017 to 07/2020
measure: tear meniscus height（mm）
timeFrame: 08/2017 to 07/2020
measure: first tear film rupture time（s）
timeFrame: 08/2017 to 07/2020
measure: average tear film rupture time（s）
timeFrame: 08/2017 to 07/2020
measure: the range of meibomian gland missing（%）
timeFrame: 08/2017 to 07/2020
measure: meibomian gland average diameter (mm)
timeFrame: 08/2017 to 07/2020
measure: meibomian gland length (mm)
timeFrame: 08/2017 to 07/2020
measure: meibomian gland area (mm^2)
timeFrame: 08/2017 to 07/2020
measure: meibomian gland deformation coefficient
timeFrame: 08/2017 to 07/2020
measure: meibomian gland total proportion of glands (%)
timeFrame: 08/2017 to 07/2020
measure: meibomian gland imaging value
timeFrame: 08/2017 to 07/2020
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01624571: Study to Assess the Effect on Recovery of GI Motility and Safety and to Determine the Optimal Dose of LD02GIFRO
Official title: A Double-blind, Multi-center, Randomized, Placebo-controlled, Parallel, Phase II Clinical Trial to Assess the Effect on Recovery of GI Motility and Safety and to Determine the Optimal Dose of LD02GIFRO in Patients Undergoing Colon Resection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Colon Resection
_large Interstinal Surgery
Lead sponsor: LG Life Sciences
Sponsor class: INDUSTRY
First posted: 2012-06-20
Enrollment: 147
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This clinical trial is conducted to determine the optimal dose of LD02GIFRO in improvement of gastrointestinal motility between each dose group by comparing the effectiveness and safety in patients undergoing colon resection.


Eligibility criteria: Inclusion Criteria:

* ≥ 20 years
* Subject is scheduled for a partial colon resection with primary anastomosis via laparotomy
* Subject is scheduled to receive primary postoperative pain management with intravenous patient-controlled analgesia (PCA) opioids

Exclusion Criteria:

* Subject is scheduled for a total colectomy, colostomy, ileostomy
* Subject has complete bowel obstruction
* Subject is scheduled for laparoscopic surgery

Primary outcomes:
measure: Improvement of gastrointestinal motility
timeFrame: in hospitalization (Maximized 14 days)
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan medical center
Study officials:
References:
Clinical trial NCT05323071: Comparison of the Efficacy of Oral Sucrose Administration at Two Different Times of a Painful Procedure in Neonates.
Official title: Comparison of the Effectiveness of Administering 24% Oral Sucrose Two Minutes Before Versus at the Same Time in the Performance of a Painful Procedure in the Neonate.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Lead sponsor: Bioaraba Health Research Institute
Sponsor class: NETWORK
First posted: 2022-04-12
Enrollment: 74
Sex: ALL
Minimum age (years): 32
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The objective of this study is to compare the use of 24% sucrose in pain control in neonates from 32 weeks of gestation onwards according to the time of administration of sucrose in venous and arterial puncture for blood collection.


Eligibility criteria: Inclusion Criteria:

* Neonates whose parents and/or guardians have signed the informed consent form.

Exclusion Criteria:

* Neonates connected to invasive mechanical ventilation.
* Neonates presenting any type of neurological alteration or showing signs of irritability prior to the puncture.
* Neonates who have received sedation.
* Neonates presenting withdrawal syndrome.

Primary outcomes:
measure: Pain during a painful procedure
timeFrame: 15 seconds after extraction
Secondary outcomes:
Other outcomes:
Locations:
city: Vitoria-Gasteiz
country: Spain
facility: Hospital Universitario Araba-Sede Txagorritxu
state: Alava
Study officials:
References:
Clinical trial NCT05833971: Cadonilimab in Combination With Chemotherapy for Locally Advaced Esophageal Squamous Cell Carcinoma
Official title: A Single-arm, Multicenter, Exploratory Study of Cadonilimab in Combination With Chemotherapy for Locally Advaced Esophageal Squamous Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Resectable Esophageal Squamous Cell Carcinoma
Neoadjuvant Therapy
Lead sponsor: Guangzhou Institute of Respiratory Disease
Sponsor class: OTHER
First posted: 2023-04-27
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a single-arm, multicenter, exploratory study to evaluate the efficacy and safety of AK104 in combination with cisplatin and paclitaxel in the treatment of resectable locally advanced esophageal squamous carcinoma.


Eligibility criteria: Inclusion Criteria:

* Age 18-70 years, both men and women
* Pathologically confirmed esophageal squamous cell carcinoma，and the clinic staging is cT2N1-3M0 or cT3N0-3M0 or cT4N0-3M0, TNM staging is II-IVA
* Non-cervical esophageal carcinoma
* Patients who have never received systemic antitumor therapy and who have measurable lesions that meet RECIST 1.1 criteria
* ECOG score 0-1
* Life expectancy ≥12 months
* Patients with normal function organs, no serious abnormalities of blood, heart, lung, liver, kidney function, and immunodeficiency disease
* For female subjects of childbearing age, they should have a negative urine or serum pregnancy test within 7 days before receiving the first study drug administration. Male and female patients need to use high-efficiency contraception during treatment until at least 8 weeks after stop the treatment
* Sign the informed consent form before any trial-related procedures are implemented

Exclusion Criteria:

* -Other malignancies diagnosed within 5 years prior to the first administration of the study drug, except effectively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or effectively resected in situ cervical and/or breast cancer
* ulcerative esophageal squamous cell carcinoma
* Esophageal or tracheal fistula
* History of allergy to study drug components
* History of immune disease
* Patients with any serious or uncontrolled systemic disease
* The presence of any adverse event (CTCAE\>grade 1) caused by prior therapy

Primary outcomes:
measure: pathologic complete response (pCR)
timeFrame: 1 month after resection
Secondary outcomes:
measure: Radical resection (R0)
timeFrame: 1 month after resection
measure: Overall survival(OS)
timeFrame: up to 2 years
measure: Objective response rate(ORR)
timeFrame: After the start of drugs and before resection
measure: Disease control rate(DCR)
timeFrame: After the start of drugs and before resection
measure: Disease-free survival(DFS)
timeFrame: After resection and up to 2 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03456271: A Prospective Cohort Study:Forecast Fracture Risk With a Serum Marker of Type 2 Diabetes in Guangzhou Community
Official title: A Prospective Cohort Study:Forecast Fracture Risk With a Serum Marker of Type 2 Diabetes in Guangzhou Community
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Type 2 Diabetes Mellitus and Fragility Fractures
Lead sponsor: Zhujiang Hospital
Sponsor class: OTHER
First posted: 2018-03-07
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: the participants were recruited from Zhujiang Hospital,Guangzhou No.12 People's Hospital,Haizhu Changgang Community,Baiyun Community Taihe Town and Tianhe Community.

Brief summary: The objective of this study is to find out the biochemical markers which have independent predictive value of fragility fractures risk with Type 2 diabetes in Guangzhou community and evaluate bone strength better and increase the ability of recognizing fracture risk through following-up visits the bone metabolism index like esRAGE-to-pentosidine ratio of the petients with type 2 diabetes and osteoporosis,compared with the classical fracture risk assessment instrument.


Eligibility criteria: Inclusion Criteria:

* (1) aged 18-65 years; (2) patients were diagnosed with type 2 diabetes based on the definition of diabetes of WHO in 1999.

Exclusion Criteria:

* 1. type 1 diabetes and other specific types of diabetes; 2. diabetes related acute complications like diabetic ketoacidosis and hyperglycemic hyperosmolar status. 3. had used drugs that is known to have effect on bone(like active vitamin D, bisphosphonate, calcitonin, estrogen receptor modulators, estrogen, thiazolidinediones); 4. suffer from diseases that is known to have effect on bone (hyperthyroidism, hypothyroidism, hyperparathyroidism, hypoparathyroidism,cushing syndrome,chronic renal failure,renal tubular acidosis,osteoporosis after gastrectomy,osteoporosis caused by liver disease,rheumatoid disease,osteoporosis induced by gastrointestinal absorption dysfunction); 5. disuse osteoporosis; 6. cannot be exposure to sunlight due to skin diseases; 7. use glucocorticoids for over 3 months.

Primary outcomes:
measure: fracture
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Baiyun Community Taihe Town
state: Guangdong
city: Guangzhou
country: China
facility: Guangzhou No.12 People's Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Haizhu Changgang Community
state: Guangdong
city: Guangzhou
country: China
facility: Tianhe Community
state: Guangdong
city: Guangzhou
country: China
facility: Zhujiang Hospital
state: Guangdong
Study officials:
References:
Clinical trial NCT03757871: Contribution of Acupuncture on Pain Related to the Screening of Premature Retinopathy (ROP) by Digital Camera
Official title: Contribution of Acupuncture on Pain Related to the Screening of Premature Retinopathy (ROP) by Digital Camera
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laser Stimulation
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2018-11-29
Enrollment: 50
Sex: ALL
Minimum age (years): 23
Maximum age (years): 31
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Pain management in premature infants is essential because they are exposed to repeated minor painful procedures such as screening for premature retinopathy (ROP). Acupuncture has shown its analgesic effectiveness in many studies. Laser acupuncture is a simple, fast, side-effect-free method, but no study exists on the contribution of acupuncture in the management of pain caused by the examination of the fundus in addition to conventional therapies (suction, Glucose G30%, anaesthetic eye drops) which are not sufficiently effective.

Hypothesis: Laser acupuncture is a medical device that would reduce the pain and discomfort of premature newborns when examining the fundus with a digital camera.

Detailed description: Randomized, single-centre, randomized, double-blind, randomized, controlled clinical trial in two parallel groups, acupuncture versus placebo as an add-on to the usual analgesic strategy (Glucose G 30%/suction and administration of a drop of anesthetic eye drops). The main objective is to evaluate the contribution of acupuncture versus placebo as an add-on to the G30% glucose solution 2 minutes before the examination associated with the instillation of a drop of oxybuprocaine administered 1 minute before the start of the examination on pain assessed at the first eye fundus (FO) by the score premature infant pain profile (PIPP) measured before the start of the examination (baseline) and on 30 seconds after the examination of both eyes.

Eligibility criteria: Inclusion Criteria:

* Premature from 23+0 to 30sa+6d regardless of birth weight with 1st FO for ROP screening;
* Premature birth weights \< 1250g with a 1st FO for ROP screening;
* Informed consent of the holder(s) of parental authority;
* Child benefiting from a social security system

Exclusion Criteria:

* Analgesic or sedative drug treatment (benzodiazepines, morphine and related) within 48 hours of the examination.
* Known chromosomal abnormality

Primary outcomes:
measure: score at PIPP (premature infant pain profile) ≥ 10
timeFrame: 24 hours
Secondary outcomes:
measure: pain and discomfort
timeFrame: 24 hours
measure: heart rate variability
timeFrame: 24 hours
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Robert Debré
Study officials:
affiliation: APHP
name: Farnoux Caroline, PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: APHP
name: Biran Valerie, PHD
role: STUDY_CHAIR
References:
Clinical trial NCT03007771: Magnetic Resonance-guided High-Intensity Focused Ultrasound (MR-HIFU) Used for Mild Hyperthermia
Official title: A Feasibility Study of Magnetic Resonance-guided High-Intensity Focused Ultrasound (MR-HIFU) Used for Mild Hyperthermia in Human Subjects
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Healthy Participants
Pelvic Neoplasms
Soft-tissue Sarcoma
Bladder Cancer
Cervical Cancer
Rectal Cancer
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2017-01-02
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: This study will help to elucidate the treatment sites in the extremities and pelvis for which MR-guided HIFU heating is feasible, which has the potential to be beneficial for patients with conditions at those sites (soft tissue sarcoma, cervical cancer, etc.). The investigators anticipate that successful completion of this study will lead to clinical trials in those feasible sites of interest to determine the safety and efficacy of administering therapeutic levels of heat for hyperthermia or other applications.


Eligibility criteria: Inclusion Criteria:

* At least 18 years of age
* Willing and able to provide informed consent
* Patients only: must have a tumor in extremity muscle tissue or in the pelvis.

Exclusion Criteria:

* Contraindications for MRI (e.g., unsafe MRI implanted devices, shrapnel, history of metal fragments in eyes, neurostimulators, excessive size and weight, claustrophobia)
* Pregnant

Primary outcomes:
measure: Feasibility of the MR-HIFU device as measured by whether an area can be heated to the designated temperature and held at that temperature for an appropriate time frame
timeFrame: 1 day (2 hour timeframe)
measure: Feasibility of the MR-HIFU device as measured by whether an area can be heated while simultaneously maintaining patient comfort
timeFrame: Up to 10 days
measure: Feasibility of the MR-HIFU device as measured by whether coupling can be maintained with the body area in the same position while having contact with the transducer for an appropriate time frame.
timeFrame: 1 day (2 hour timeframe)
Secondary outcomes:
measure: Behavior of hyperthermia delivery as measured by the build-up of time until the different treatment cells can reach a desired uniform temperature
timeFrame: 1 day (2 hour time frame)
measure: Behavior of hyperthermia delivery as measured by if the heating cell behavior is the same in healthy and tumor tissues
timeFrame: 1 day (2 hour time frame)
measure: Behavior of hyperthermia delivery as measured by post-treatment heat diffusion behavior to anticipate any issues when heat is given at a clinically relevant level
timeFrame: Up to 10 days
Other outcomes:
Locations:
Study officials:
affiliation: Washington University School of Medicine
name: Michael Altman, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06528171: Covid-19 Long Immunité IMagerie (CLIIM)
Official title: Specific Markers of Covid-long Syndrome: Identifying the Mechanisms Involved With a View to Defining Diagnostic Criteria
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: COVID Long-Haul
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2024-07-30
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Covid-long pathology affects a large number of patients, and represents a major medical, economic and societal challenge. To date, we have no objective criterion for a definitive diagnosis, nor any predictive tool for monitoring the evolution of Covid-long. Based on recruitment from the infectious diseases department of Nice University Hospital, the investigator's team wants to conduct an innovative pathophysiological study to better define the disease and identify specific biomarkers that could subsequently be used as a diagnostic tool for Covid-long. 120 participants will be initially included for the model learning phase: 60 controls in the CL- cohort and 60 patients in the CL+ cohort. Then 80 patients (40 CL+ and 40 Cl-) will be enrolled for the model validation phase.


Eligibility criteria: FOR CL+ PATIENTS

Inclusion Criteria:

* Case definition in line with WHO Delphi process

Exclusion Criteria:

* History of chronic fatigue syndrome diagnosed before or after Covid.
* History of progressive psychiatric pathology.
* History of acute Covid requiring admission to intensive care and mechanical ventilation.
* No social security affiliation.

FOR CONTROL (CL-)

Inclusion Criteria:

* History of acute COVID-19, mild, moderate or severe (episode at least 3 months at the time of inclusion).
* Absence of persistent symptoms more than 3 months after first Covid symptoms (or mild not affecting daily activities).

Exclusion Criteria:

* History of progressive psychiatric pathology.
* History of acute Covid requiring admission to intensive care and mechanical ventilation.
* No social security affiliation.
* Pregnant or breast-feeding.

Primary outcomes:
measure: Predictive model of Covid-long
timeFrame: 24 months
Secondary outcomes:
measure: Evolution of these markers over time
timeFrame: 24 months
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de NICE
Study officials:
References: