louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02716025: Serum Zinc, Peptic Ulcer Disease and H. Pylori Infection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peptic Ulcer Disease
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2016-03-22
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with symptoms suggestive of peptic ulcer disease like epigastric pain, dyspepsia, heartburn who were candidates for upper gastrointestinal endoscopy.

Brief summary: Fifty consecutive patients with symptoms suggestive of peptic ulcer disease were included. All underwent complete clinical evaluation, laboratory investigations, upper gastrointestinal endoscopy and rapid urease test. Measurement of serum zinc level was done for all the included patients in addition to twenty five age and sex matched healthy control subjects.


Eligibility criteria: Inclusion Criteria:

* Symptoms suggestive of peptic ulcer disease like epigastric pain, dyspepsia, heartburn

Exclusion Criteria:

* Patients who received zinc supplementation, proton pump inhibitors (PPI), non-steroidal anti-inflammatory drugs (NSAIDs)
* Those presented with hematemesis or melena
* Those with chronic liver disease, renal failure, malabsorption or previous gastric surgery

Primary outcomes:
measure: Detection of positive upper GIT endoscopic findings
timeFrame: upon endoscopy
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05057325: Post Operative Pain Assessment After Pulpectomy of Primary Molars With Two Different Rotary Systems
Official title: Post Operative Pain After Pulpectomy of Primary Molars With One Shap Rotation File Versus Wave One Reciprocating File
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulp Necroses
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2021-09-27
Enrollment: 164
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Evaluation of post operative pain after pulpectomy procedures for primary molars with irreversible pulp damage and without periapical radulicency using two different systems (One shape file ( ratation movemont) and wave one gold file ( reciprocation movement)


Eligibility criteria: Inclusion Criteria:

* Age of more than 4 years
* Healthy children
* Primary molars with irreversible pulp damage

Exclusion Criteria:

* Presence of periapical radiolucency realtes to primary molar
* Uncooperative child

Primary outcomes:
measure: Post operative pain
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Minia University
Study officials:
References:
Clinical trial NCT03453125: Improving Learning in Hispanics With TBI or MS
Official title: Improving Learning in Hispanics With TBI or MS: A Pilot Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: TBI (Traumatic Brain Injury) or MS (Multiple Sclerosis)
Keywords: cognitive rehabilitation
memory
Lead sponsor: Kessler Foundation
Sponsor class: OTHER
Collaborators: name: Instituto Vocacional Enrique Díaz de León A.C., Guadalajara, Mexico
First posted: 2018-03-05
Enrollment: 40
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 goal of this study is to establish that a memory retraining protocol, originally developed for English-speakers, and translated into Spanish, is effective.

Detailed description: A pilot study will be conducted to carry out this validation and resolve any methodological concerns in the translated protocol. 20 Spanish-speaking Hispanics at least one year post-traumatic brain injury (TBI) and 20 Spanish-speaking Hispanics with multiple sclerosis (MS), both with an objective deficit in learning and memory will be recruited. Baseline assessment includes neuropsychological evaluation using traditional measures as well as completion of a number of questionnaires designed to measure everyday memory and everyday functioning. Subjects are randomly assigned to either the experimental or control groups. Experimental and control treatments includes two 45-60 minute sessions, twice per week, for 5 weeks. Follow-up assessment includes a neuropsychological evaluation using traditional measures as well as completion of a number of questionnaires designed to measure everyday memory and everyday functioning. Protocol efficacy will be determined by improvements between baseline and follow-up on an objective measure of learning and memory.

Eligibility criteria: Inclusion Criteria:

* between the ages of 18 and 65
* Spanish is my dominant language, and I have had a traumatic brain injury or I have multiple sclerosis.

Exclusion Criteria:

* Participants with major depressive disorder, schizophrenia, bipolar disorder I or II
* MS subjects: Individuals with a history of head injury, stroke, seizures, or any other significant neurological history will not be included in the study.
* TBI subjects: Individuals must have sustained a TBI at least one year prior to enrollment in the study protocol. Individuals with a history of significant neurological insult other than TBI (e.g. premorbid epilepsy, multiple sclerosis, Alzheimer's disease) will not be included in the study.

Primary outcomes:
measure: Total learning post-treatment (covarying for baseline performance)
timeFrame: 7 weeks (between pre- and post testing)
Secondary outcomes:
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Kessler Foundation
state: New Jersey
city: Arrasate-Mondragón
country: Spain
facility: Hospital Aita Menni
Study officials:
affiliation: Kessler Foundation
name: Nancy Chiaravalloti, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05531825: Clinical Evaluation Study of a Device for Detecting Arteriovenous Fistula Vascular Function
Official title: Clinical Evaluation Study of a Device for Detecting Arteriovenous Fistula Vascular Function
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Arteriovenous Fistula Flow Monitoring
Early Detection of Complications of Arteriovenous Fistula
Voiceprint
Lead sponsor: Shanghai 10th People's Hospital
Sponsor class: OTHER
First posted: 2022-09-08
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with end-stage renal disease undergoing or planning regular hemodialysis with autologous arteriovenous fistulas

Brief summary: Evaluation on the reliability, practicability and safety of a wearable device for measuring arteriovenous fistula function based on voice print.

Detailed description: Arteriovenous fistula is the lifeline of maintenance hemodialysis patients. At present, there is a lack of a simple wearable real-time evaluation technology and device for arteriovenous fistula, which can help doctors find and deal with the complications of arteriovenous fistula timely and accurately. This study proposes an innovative design based on PVDF piezoelectric membrane by combining all kinds of technologies including NB-iot/4G transmission mode to realize real-time monitoring and feedback of the health status of arteriovenous fistula vessels, so that the use time of arteriovenous fistula can be prolonged and the survival rate of dialysis patients can also be improved.

Eligibility criteria: Inclusion Criteria:

* Age 18-75.
* Patients diagnosed with end-stage renal failure and planning to undergo venous fistula surgery or maintenance hemodialysis.
* Sign the informed consent.

Exclusion Criteria:

* Pregnant and lactating women, bipolar disorder, schizophrenia and other serious mental illness.
* Other circumstances deemed inappropriate by the researcher
* Quit midway

Primary outcomes:
measure: Correlation between voiceprint spectrum and the blood flow of arteriovenous fistula
timeFrame: 2 month
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Nephrology & Rheumatology, Shanghai Tenth People's Hospital
state: Shanghai
Study officials:
affiliation: Shanghai 10th People's Hospital
name: Ai Peng, MD,PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02740725: The Role of Interactive Binocular Treatment System in Amblyopia Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Amblyopia
Keywords: Amblyopia
Interaction Binocular Treatment (I-BiTTM)
Patch Therapy
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2016-04-15
Enrollment: 50
Sex: ALL
Minimum age (years): 4
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Purpose: of determining the role of Interactive Binocular Treatment (I-BiTTM) as a complementary method of patching in amblyopia therapy.

Materials and Methods: In this randomized clinical trial study, 50 unilateral amblyopic children (25 male/25 female) less than 10 years with either best corrected visual acuity (BCVA) ≤0.3 LogMAR (Logarithm minimum angle of resolution) in amblyopic eye or difference of VA≥2 lines between two eyes will be included. Patients will be classified in the case and control groups (25 in each), randomly. Patching will be recommended in both, cases will also received I-BiTTM. The child will be asked to play I-BiTTM games through glasses with conjugate colored filters. Patching was continued for one month more in both groups. VA and stereoacuity were measured at baseline, one month at the end of I-BiTTM treatment and one month after I-BiTTM treatment.

Detailed description: In this clinical trial study, our case group will receive I-BiTTM in the format of three playing games which have been designed suitable to the age of our cases. The mechanism of I-BiTTM has been designed in three playing games with inducing more foveal stimulation for the amblyopic eye through presentation of movable targets with more detailed. In addition, unmovable targets will presented to the non-amblyopic eyes. Playing games were continued 30 minutes in each session for 5 days in each week within one month.

Eligibility criteria: Inclusion Criteria:

* BCVA \<= 0.3 LogMAR

Exclusion Criteria:

* Organic Amblyopia
* Age less than 4 years
* Nystagmus

Primary outcomes:
measure: Best Corrected Visual Acuity, Stereopsis
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Islamic Republic of Iran
Study officials:
affiliation: Ophthalmic Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
name: Zhale Rajavi, Professor
role: STUDY_DIRECTOR
References:
citation: Rajavi Z, Sabbaghi H, Amini Sharifi E, Behradfar N, Yaseri M. The role of Interactive Binocular Treatment system in amblyopia therapy. J Curr Ophthalmol. 2016 Aug 9;28(4):217-222. doi: 10.1016/j.joco.2016.07.005. eCollection 2016 Dec.
Clinical trial NCT06974825: A Study of BGM0504 in Chinese Patients With Type 2 Diabetes
Official title: A Randomized, Double-blind, Placebo and Positive Drug Parallel-controlled Phase IIa Clinical Study Protocol to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Characteristics of Multiple-dose BGM0504 Injection in Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes
Lead sponsor: BrightGene Bio-Medical Technology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-05-16
Enrollment: 67
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 purpose of this study is to evaluate the efficacy and safety of BGM0504 in Chinese patients with Type 2 Diabetes.


Eligibility criteria: Inclusion Criteria:

* Have been diagnosed with type 2 diabetes mellitus (T2DM);
* Glycosylated hemoglobin (HbA1c) at screening/baseline: 7.0% ≤ HbA1c ≤ 10%;
* Body Mass Index (BMI): 19.5 kg/m2 ≤ BMI ≤ 35.0 kg/m2;
* Fasting blood glucose (FPG) at screening/baseline: FPG ≤ 13.3 mmoL/L

Exclusion Criteria:

* Diagnosed with non-type 2 diabetes mellitus;
* Grade 3 hypoglycemia within 6 months prior to screening;
* Concomitant thyroid dysfunction that cannot be controlled at a stable drug dose at screening, or clinically significant abnormalities in thyroid function test results at screening that require initiation of therapy;
* Subjects with uncontrolled hypertension after treatment (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg at screening) or untreated blood pressure meeting the above criteria at screening;
* Patients with a previous history or clinical evidence of acute or chronic pancreatitis;
* Malignant tumor confirmed within 5 years prior to screening (except cured carcinoma in situ) or potential malignant tumor assessed at screening;
* Patients with severe mental illness or language disorder at screening, unwilling or unable to fully understand and cooperate;
* Female subjects during pregnancy or lactation.

Primary outcomes:
measure: Change From Baseline in Hemoglobin A1c (HbA1c)
timeFrame: Week 0 to Week 12
Secondary outcomes:
measure: Change From Baseline in Body Weight
timeFrame: Week 0 to Week 12
measure: Percentage of Participants With HbA1c Target Value of <7%
timeFrame: Week 0 to Week 12
measure: Percentage of Participants With HbA1c Target Value of <6.5%
timeFrame: Week 0 to Week 12
measure: Change From Baseline in Fasting Serum Glucose
timeFrame: Week 0 to Week 12
Other outcomes:
Locations:
city: Changsha
country: China
facility: The Third Xiangya Hospital of Central South University
state: Hunan
Study officials:
References:
Clinical trial NCT03428425: A Study of HIPEC Plus Apatinib and S-1 Conversion Therapy for Gastric Cancer With Positive Exfoliative Cancer Cells
Official title: A Study of HIPEC Plus Apatinib and S-1 Conversion Therapy for Gastric Cancer With Positive Exfoliative Cancer Cells
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Gastric Cancer
Lead sponsor: Hebei Medical University
Sponsor class: OTHER
First posted: 2018-02-09
Enrollment: 38
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: The purpose of this study is to investigate the efficacy and safety of HIPEC plus apatinib and S-1 in the conversion therapy of gastric cancer with positive exfoliative cancer cells


Eligibility criteria: Inclusion Criteria:

* 1. Untreated (e.g. chemotherapy, radiotherapy and other antitumor therapy); 2. Age:18 to 70 years old; 3. Man or female (except pregnant and lactating women); 4. Conﬁrmed to gastric adenocarcinoma; 5. Proven gastric cancer of T stage was T3 and T4, and no distant metastasis was observed. The exfoliative cancer cells detection in peritoneal washes was positive; 6. Blood cell count has to meet the following certeria: WBC≥3.5×109/L; ANC≥1.5×109/L; PLT≥100×109/L; HB≥90g/L; 7. Liver/kidney function has to meet the following certeria: ALT and AST≤2.5×ULN TBIL\<1.5×ULN； Serum creatinine ≤1.5×ULN; 8. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1; 9. Participants were willing to join in this study, good adherence and written informed consent.

Exclusion Criteria:

- 1. Patients with other malignant tumors within 5 years; 2. Metastasis was found to be visible to the naked eye; 3. It has serious or uncontrolled heart diseases and infections (Including atrial fibrillation, angina pectoris, cardiac insufficiency, ejection fraction less than 50%, poor-controlled hypertension and so on); 4. History of psychiatric drugs abuse and can't quit or patients with mental disorders; 5. Patients with severe or uncontrollable mental illness; 6. Patients with tendency of gastrointestinal bleeding, including the following: a local active ulcerative lesions, and defecate occult blood (+ +).Has melena and hematemesis in two months; 7. Pregnant or lactating women; 8. It have serious harm to the patient's safety or affect the patients who have completed the research.

9. The researchers think inappropriate.

Primary outcomes:
measure: R0-resection rate
timeFrame: within 3 weeks after surgery
measure: Conversion to negative rate
timeFrame: within 3 weeks after surgery
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: 5years
measure: Progression free survival (PFS)
timeFrame: 5years
measure: Adverse events
timeFrame: 5 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02389725: The Effect of Two Different Tourniquet Techniques on Peripheral IV Access Success Rates
Official title: The Effect of Two Different Tourniquet Techniques on Peripheral IV Access Success Rates
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tourniquet
Keywords: peripheral intravenous access
tourniquet techniques
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2015-03-17
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to compare the success rates of two different tourniquets that are used when placing an IV.


Eligibility criteria: Inclusion Criteria:

* Emergency Department patients
* 18 years old or older
* who receive peripheral IV access

Exclusion Criteria:

* Patients under the age of 18
* prison inmates
* pregnant patients
* patients who are unable to give informed consent
* critically ill patients who need emergent IV access as defined by the Emergency Medicine consultant of record for the patient

Primary outcomes:
measure: Peripheral IV Access Success Rate
timeFrame: baseline
Secondary outcomes:
measure: Total Number of Peripheral IV Access Attempts
timeFrame: baseline
measure: Total Number of Distinct Providers That Attempted IV Access
timeFrame: baseline
measure: Rate of Rescue Techniques Used
timeFrame: baseline
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Tobias Kummer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tran T, Lund SB, Nichols MD, Kummer T. Effect of two tourniquet techniques on peripheral intravenous cannulation success: A randomized controlled trial. Am J Emerg Med. 2019 Dec;37(12):2209-2214. doi: 10.1016/j.ajem.2019.03.034. Epub 2019 Mar 23.
Clinical trial NCT03087825: Preoxygenation Method With a Calibrated Leak
Official title: Effect of Preoxygenation With Spontaneous Breathing or Noninvasive Positive Pressure Ventilation With or Without a Calibrated Leak. An Experimental Study in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preoxygenation
Non Invasive Ventilation
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2017-03-23
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 2 groups : spontaneous breathing and non invasive pressure support ventilation 2 conditions : without inward air leak and with inward air leak
Primary purpose: PREVENTION

Brief summary: During preoxygenation, imperfect seal between the face mask and patient's face can induce an inward air leak decreasing its effectiveness. We assume that noninvasive ventilation could cancel the effect of the leak.

This is a prospective study. Healthy volunteers are randomised in cross-over between spontaneous breathing or noninvasive ventilation pressure support preoxygenation in the presence or absence of a calibrated leak on the inspiratory circuit.

Detailed description: During preoxygenation, imperfect seal between the face mask and patient's face can induce an inward air leak decreasing its effectiveness. We assume that noninvasive ventilation could cancel the effect of the leak.

We planned an experimental study with healthy volunteers (residents in anesthesiology).

Healthy volunteers are randomised in cross-over between preoxygenation through spontaeous breathing or noninvasive ventilation pressure support preoxygenation in the presence or absence of a calibrated leak on the inspiratory circuit. The inspiratory fraction of oxygen is 100%. The exhaled gas (oxygen and carbon dioxide) are monitored.The subjects breathed through a mouthpiece (with a nose clip) connected to an anesthetic ventilator.

The primary endpoint is the time to achieve end expiratory fraction of oxygene of 90% or more.

The secondary endpoint is the proportion of subject with end expiratory fraction of oxygen of 90% or more after a 3 min period (recommended in clinical guidelines).

Eligibility criteria: Inclusion Criteria:

* healthy volunteers

Exclusion Criteria:

* any pathological condition
* active tobaco

Primary outcomes:
measure: end expiratory fraction of oxygen
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: University Hospital of Caen
Study officials:
affiliation: CHU de Caen and universite Caen Normandie
name: jean-luc hanouz, m.D,ph.d
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hanouz JL, Le Gall F, Gerard JL, Terzi N, Normand H. Non-invasive positive-pressure ventilation with positive end-expiratory pressure counteracts inward air leaks during preoxygenation: a randomised crossover controlled study in healthy volunteers. Br J Anaesth. 2018 Apr;120(4):868-873. doi: 10.1016/j.bja.2017.12.002. Epub 2018 Jan 17.