louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03883035: Quality Control of Esophagogastroduodenoscopy Using Real-time EGD Auxiliary System
Official title: Utilization of Real-time Automatic Quality-control System in the Detection of Gastric Neoplasms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Esophagogastroduodenoscopy
Keywords: Esophagogastroduodenoscopy
gastric neoplasm
artificial intelligence
quality control
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2019-03-20
Enrollment: 1060
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The aim of our study was to develop an automatic quality-control system and assess the performance of this system in quality control of esophagogastroduodenoscopy.

Detailed description: In this study, the researchers firstly developed an automatic quality-control system, name as EAS. Next, the researchers applied the system in a endoscopic center and designed a prospective randomised controlled trial to investigate the performance of the system in quality control of esophagogastroduodenoscopy.

Eligibility criteria: Inclusion Criteria:

* patients undergoing EGD examination with anaesthesia;
* patients able to give informed consent.

Exclusion Criteria:

* patients with the contraindications to EGD examination;
* patients with a prior EGD examination within 1 year before the trial;
* patients with frankly upper gastrointestinal malignant lesions that were apparent on endoscopy;
* a history of upper gastrointestinal cancers;
* allergic to anaesthetic in previous medical history;
* patients refused to participate in the trial;
* the EGD procedure cannot be completed due to stenosis, obstruction, solid food, or complications of anaesthesia.

Primary outcomes:
measure: detection rate of gastric neoplasms
timeFrame: 8 months
Secondary outcomes:
measure: mean number of gastric neoplasms detected
timeFrame: 8 months
measure: mean inspection completeness
timeFrame: 8 months
measure: mean inspection time
timeFrame: 8 months
measure: errors of EAS
timeFrame: 8 months
Other outcomes:
Locations:
city: Jinan
country: China
facility: Department of Gastroenterology, Qilu Hospital, Shandong University
state: Shandong
Study officials:
References:
Clinical trial NCT06978335: Acupoint Stimulation Improves Postoperative Wound Pain
Official title: Acupoint Stimulation Intervention Improves Postoperative Wound Pain and Mobility in Patients With Abdominal Surgery
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Abdominal Surgeries
Pain
Acupuncture Points
Keywords: acupoint stimulation
postoperative pain
Lead sponsor: Cheng-Hsin General Hospital
Sponsor class: OTHER
First posted: 2025-05-18
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Postoperative pain remains one of the most common and distressing symptoms experienced by surgical patients. Poorly managed postoperative pain can impede recovery, reduce patient willingness to mobilize, increase the risk of complications, and negatively affect overall quality of life. Currently, opioids and nonsteroidal anti-inflammatory drugs (NSAIDs) are the primary pharmacological strategies for managing postoperative pain. However, these medications often carry the risk of adverse effects and may not adequately address all aspects of patient comfort and recovery.

In response to this challenge, this study aims to evaluate the effects of a non-pharmacological, non-invasive intervention-acupoint stimulation-on postoperative wound pain and mobilization in patients undergoing abdominal surgery. Ultimately, this study seeks to contribute to the development of more diversified and patient-centered pain management strategies, with the expectation that the integration of Chinese and Western medicine will lead to improved patient care and enhanced postoperative recovery.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Surgical wound length ≥ 10 cm
* American Society of Anesthesiologists (ASA) physical status classification I to III
* Receiving intravenous patient-controlled analgesia (IV PCA)
* Clear consciousness and ability to communicate
* Willingness to participate and provide informed consent

Exclusion Criteria:

* Presence of arrhythmia
* Implanted artificial cardiac pacemaker
* Cutaneous lesions at the acupoint or auricular application sites
* History of chronic pain or abdominal surgery within the past 6 months
* Non-ambulatory status prior to surgery

Primary outcomes:
measure: Pain Intensity Measured by Visual Analog Scale (VAS)
timeFrame: At 1, 4, 12, 24, 48, and 72 hours post-surgery
Secondary outcomes:
measure: Pain Impact Assessed by Brief Pain Inventory - Taiwan Version (BPI-Taiwan)
timeFrame: On postoperative Day 3
Other outcomes:
measure: Total Analgesic Consumption Within 72 Hours After Surgery
timeFrame: Within 72 hours after surgery
measure: Time to First Ambulation After Surgery
timeFrame: Within 72 hours after surgery
Locations:
city: Taipei
country: Taiwan
facility: Cheng Hsin General Hospital
state: Peitou Dist
Study officials:
References:
Clinical trial NCT04305535: Impact of an Oligomeric Diet in Intestinal Absorption and Inflammatory Markers in Patients With Crohn Disease
Official title: Clinical Trial to Evaluate the Effect of an Oligomeric Oral Nutritional Supplement on the Response in Intestinal Absorption and Inflammation, in Patients With CROHN Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Crohn Disease
Absorption; Disorder, Protein
Absorption; Disorder
Absorption; Disorder, Fat
Absorption; Disorder, Carbohydrate
Malnutrition
Keywords: Oligomeric diet
Peptidic diet
Probiotics
Oral Nutritional Supplements
Lead sponsor: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Sponsor class: OTHER
Collaborators: name: Adventia Pharma
name: Biopolis S.L.
First posted: 2020-03-12
Enrollment: 162
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: This is a randomized, multicenter, translational, triple-blind, clinical trial in patients with Crohn's disease, who will be prescribed an oral nutritional supplement to control symptoms in the acute phase and to recover in the remission phase.

Detailed description: Multicentric, parallel, randomized, double blind and controlled clinical-nutritional study of 6 months of intervention and 3 study groups of treatment: Experimental group (peptidic diet with a mix of probiotics); Experimental group with placebo (peptidic diet with a placebo); and Control group (control with a polymeric nutritional oral supplement with a placebo) to evaluate the effect on the nutritional status, inflammatory markers and the intestinal absorption

Eligibility criteria: Inclusion Criteria:

* Unintentional weight loss of 5% in 6 months or a BMI less than 20kg/m2 or does not get the energy requirements with normal food.
* Willing to comply with the prescribed diet follow-up for CD.

Exclusion Criteria:

* Having received antibiotics in the previous 3 months
* Having undergone intestinal resection surgery≥70-75%
* Refuse to participate in the study
* Comorbidity that allows to suspect survival \<1 year

Primary outcomes:
measure: Malabsorption
timeFrame: 6 months
Secondary outcomes:
measure: Changes in the consistency of the stools according to Bristol scale.
timeFrame: 6 months
measure: Fat malabsorption
timeFrame: 6 months
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Miguel Aganzo Yeves
Study officials:
affiliation: Hospital Universitario Fundación Jiménez Díaz
name: Miguel Aganzo-Yeves, RD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario Fundación Jiménez Díaz
name: Clotilde Vázquez-Martínez, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05588635: Association Between Live Birth Rate and Serum Progesterone During Hormonal Replacement Therapy
Official title: Association Between Live Birth Rate and Serum Progesterone on Frozen-thawed Embryo Transfer Day: Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ovarian Hyperstimulation Syndrome
Frozen-thawed Embryo Transfers
Keywords: serum progesterone
frozen-thawed embryo transfer
live birth rate
Lead sponsor: Centre Hospitalier Régional Metz-Thionville
Sponsor class: OTHER
First posted: 2022-10-20
Enrollment: 168
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 43
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patient having frozen-thawed single embryo transfer of a day-5 blastocyst with hormonal replacement therapy

Brief summary: Nowadays, frozen-thawed embryo transfers (FET) are expending. This practice avoids risk of ovarian hyperstimulation syndrome (OHSS), as well as allowing better synchronization between endometrium and embryo, which is fundamental for pregnancy.

There are several FET protocols, including hormonal replacement therapy cycle (HRT), which enable clinicians to adapt the day of embryo transfer.

However, increase in spontaneous miscarriages was observed with this latter protocol compared to fresh embryo transfers and the other endometrial preparations (natural and stimulated), in relation with the lack of physiological corpus luteum.

Then, Clinicians interrogate about measuring serum progesterone in order to adjust their treatment and/or transfer date. Various studies have shown thresholds below and/or above which pregnancy or live birth rate were lowered.

The main objective is to find a serum progesterone threshold on the day of embryo transfer above which live birth rate is increased. The secondary objectives are to analyze the factors associated with increased serum progesterone on the day of transfer, to analyze the miscarriage rate, and impact of change on luteal phase support on day 12.


Eligibility criteria: Inclusion Criteria:

* women between 18 and 43,
* having frozen-thawed single embryo transfer of a day-5 blastocyst with hormonal replacement therapy, with measurement of serum progesterone on the day of transfer

Exclusion Criteria:

* frozen-thawed transfer of a day-2 or -3 or -6 embryo,
* double embryo transfer,
* other protocol than HRT,
* patient without serum progesterone measurement on the day of transfer

Primary outcomes:
measure: Identification of factors on the embryo transfer day that predict live birth after frozen-thawed embryo transfer
timeFrame: On the day of embryo transfer (Day 0)
Secondary outcomes:
measure: Pregnancy status
timeFrame: 12 days after embryo transfer (Day 12)
measure: Serum progesterone
timeFrame: 12 days after embryo transfer (Day 12)
Other outcomes:
Locations:
city: Metz
country: France
facility: CHR Metz-Thionville/Hopital de Mercy
Study officials:
affiliation: CHR Metz Thionville Hopital de Mercy
name: Ariane GOUTALAND, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03160235: Development of MRI Protocols and Associated Explorations (EEG, NIRS) in Voluntary Patients
Official title: Development of MRI Protocols and Associated Explorations (EEG, NIRS) in Voluntary Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Magnetic Resonance Imaging
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2017-05-19
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Methodological development of new MRI approaches
Primary purpose: BASIC_SCIENCE

Brief summary: Studies that will be carried out on healthy volunteers will have as main objective the development and optimization of the parameters of sequences or the design of the paradigms of stimulation in order to optimize the quality and the relevance of the images realized taking in Taking account of anatomical, functional or metabolic parameters, or integrating new approaches resulting from technical evolutions

Detailed description: The pathologies that interest us in these refinements concern mainly the chronic (or sequellar) brain disorders which can be degenerative, developmental or vascular. The patients who will be recruited will be known patients of our Service (University Clinic of Neuroradiology and MRI) that we follow during checks. The type of examination that will be applied to them, between MRI, EEG and NIRS, will be specified in the consent form. These examinations will not be invoiced either to the patient or to the social security, and the related costs will be borne by our Federative Research Structure or sometimes, when these explorations are upstream of a defined research protocol and funded, They will be financed under this protocol.

Eligibility criteria: Inclusion Criteria:

* major voluntary patients
* socially insured.
* Karnofsky score above 60%.
* given their consent.
* absence of contraindication to the MRI examination

Exclusion Criteria:

* Subjects under the age of 18
* pregnant women
* persons referred to in articles L1121-5 to L1121-8 of the CSP.
* Patients with acute illness

Primary outcomes:
measure: Spatial resolution of new MRI imaging sequences MRI scanning.
timeFrame: Two hours
Secondary outcomes:
Other outcomes:
Locations:
city: Grenoble
country: France
facility: CHU Grenoble-Alpes
Study officials:
References:
Clinical trial NCT05613335: Crestal Sinus Technique Using Autologous Fibrin Glue Vs Sticky Bone With Simultaneous Implant Insertion.
Official title: Minimal Invasive Crestal Sinus Technique Using Autologous Fibrin Glue Versus Sticky Bone With Simultaneous Implant Insertion. A Prospective Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Missed Upper Posterior Teeth
Keywords: Crestal sinus lift
Autologous fibrin glue
Sticky bone
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2022-11-14
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: prospective comparison of minimal Invasive Crestal Sinus Technique Using Autologous Fibrin Glue Vs Sticky Bone with simultaneous implant insertion.

Detailed description: The aim of this study is to evaluate the clinical and radiographic outcomes of applying fibrin glue versus sticky bone in conjunction with crestal sinus lift technique associated with simultaneous implant insertion.

Eligibility criteria: Inclusion Criteria:

- a) Patients should be willing to be present for regular timely follow up. b) Residual bone height range from 5 to 9mm c) Patent ostium of maxillary sinus. d) Patients having missing maxillary posterior teeth. e) Patient cooperation and compliance are indispensible for a predictable clinical outcome.

f) Patients free from any systemic disease

Exclusion Criteria:

* 1) Patients with systemic disease that prevent surgical intervention or bone healing.

  2) Patients with acute or chronic maxillary sinusitis. 3) Patients with cyst, tumor or root tips at the planned surgical site. 4) Heavy smoker patients. 5) Elderly patients (over 60 years). 6) Patients with Poor oral hygiene or aggressive periodontal diseases. 7) Lack of motivation or inability to maintain oral hygiene.

Primary outcomes:
measure: Implant stability
timeFrame: 3 months
measure: Bleeding
timeFrame: 3 months
measure: Radiographic evaluation
timeFrame: immediate postoperative
Secondary outcomes:
measure: implant stability
timeFrame: 6 months
measure: Bleeding
timeFrame: 6 months
measure: Radiographic evaluation
timeFrame: 6 months
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University
state: Dakahlya
Study officials:
References:
Clinical trial NCT05810935: Safety of Antibiotic Intake During Pregnancy
Official title: Safety of Antibiotic Intake During Pregnancy: Results of Questionnaire of Pregnant Women in Two Arab Countries
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infections
Keywords: antibiotics, infection
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2023-04-13
Enrollment: 384
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: this study is an observational cross sectional study that will be conducted on pregnant female above the age of 18 years old iwith exclusion of any female with any psychological disability.

Brief summary: this study will be conducted to assess the knowledge of the pregnant females regarding safety of antibiotic intake ,also their attitude toward any prescribed antibiotics during their pregnancy .

Detailed description: this study will be conducted on pregnant females from two Arab countries to assess their knowledge and attitude toward any prescribed antibiotics while they are pregnant .Also to assess any malpractice while their intake for any antibiotics . this study is a cross sectional study that will involve a questionnaire including the three mentioned domains .

Eligibility criteria: Inclusion Criteria:

* pregnant women at any gestational age

Exclusion Criteria:

* pregnant women who refused to participate

Primary outcomes:
measure: Number of participants with antibiotic-related side effects
timeFrame: through study completion ,an average of one year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03389035: Transposon-manipulated Allogeneic CARCIK-CD19 Cells in Pediatric and Adult Patients With r/r ALL Post HSCT
Official title: Phase 1-2a Trial to Determine the Feasibility and Safety of a Single Dose of Transposon-manipulated Allogeneic CARCIK-CD19 Cells in Adult and Pediatric Patients With Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia, After Hematopoietic Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Acute Lymphoblastic Leukemia, in Relapse
Keywords: Acute Lymphoblastic Leukemia
CAR-T
CARCIK
Transposon
Lead sponsor: Fondazione Matilde Tettamanti Menotti De Marchi Onlus
Sponsor class: OTHER
First posted: 2018-01-03
Enrollment: 21
Sex: ALL
Minimum age (years): 1
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This is a single arm, open-label, multi-center, phase 1-2a study to determine the Maximum Tolerated Dose and/or the Recommended Phase 2 Dose and the safety of CARCIK-CD19 in adult and pediatric patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia.


Eligibility criteria: Inclusion Criteria:

* Children (1-17) and adults (18-75 years old);
* Relapsed or refractory adult and pediatric B-cell precursor ALL after HSCT;
* Evidence of CD19 tumor expression in bone marrow and/or peripheral blood by flow cytometry;
* Bone marrow with ≥ 5% lymphoblasts by morphologic assessment at screening;
* No evidence of overall aGVHD \> Grade I or chronic GVHD (cGVHD) greater than mild at time of enrollment and in the previous 30 days;
* No longer taking immunosuppressive agents for at least 30 days prior to enrollment;

Exclusion Criteria:

* Patients with GVHD Grades II-IV;
* Any cell therapy in the last 30 days;

Primary outcomes:
measure: Dose Limiting Toxicities (DLT):
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Bergamo
country: Italy
facility: Ospedale PG23
state: BG
city: Monza
country: Italy
facility: Fondazione MBBM
state: MB
Study officials:
References:
citation: Magnani CF, Gaipa G, Lussana F, Belotti D, Gritti G, Napolitano S, Matera G, Cabiati B, Buracchi C, Borleri G, Fazio G, Zaninelli S, Tettamanti S, Cesana S, Colombo V, Quaroni M, Cazzaniga G, Rovelli A, Biagi E, Galimberti S, Calabria A, Benedicenti F, Montini E, Ferrari S, Introna M, Balduzzi A, Valsecchi MG, Dastoli G, Rambaldi A, Biondi A. Sleeping Beauty-engineered CAR T cells achieve antileukemic activity without severe toxicities. J Clin Invest. 2020 Nov 2;130(11):6021-6033. doi: 10.1172/JCI138473.
Clinical trial NCT01622335: Effect OF Nitrous Oxide On Acute Pain and Opioid Consumption, and Chronic Pain After Hysterectomy
Official title: Effect OF Nitrous Oxide On Acute Pain and Opioid Consumption, and Chronic
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Abdominal Hysterectomy (& Wertheim)
Nitrous Oxide
General Anesthesia
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2012-06-19
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study is prospective and double blind. In the clinic, patients undergoing hysterectomy that meet the criteria for inclusion into the study and agreed to participate in the study will be randomized into two groups.

Detailed description: The study is prospective and double blind. In the clinic, patients undergoing hysterectomy that meet the criteria for inclusion into the study and agreed to participate in the study will be randomized into two groups. In the first group of patients will receive Nitrous Oxide and In the second group of patients will receive oxygen during the general anesthesia.

Eligibility criteria: Inclusion Criteria:

* 18 to 65 years old at time of the first procedure
* Female
* American Society of Anesthesiologists physical status I or II
* Hysterectomy undergoing the general anesthesia

Exclusion Criteria:

* Neuropathic disease
* Chronic opioid users
* Contraindication for Nitrous Oxide receive
* Consent will not be obtained patient
* Psychiatric disorders
* Current or recent drug abuse (within past 6 months).

Primary outcomes:
measure: Nitrous oxide and chronic pain
timeFrame: 30 days post operative
measure: Nitrous oxide and opioid consumption
timeFrame: 4 hours post operative
Secondary outcomes:
Other outcomes:
Locations:
city: Etlik
country: Turkey
facility: Gulhane Military Medical Academy Hospital
state: Ankara
Study officials:
affiliation: The Cleveland Clinic
name: Alparslan Turan, M.D.
role: PRINCIPAL_INVESTIGATOR
References: