louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06680882: The Effect of Non-invasive Auricular Acupoint Stimulation on Slow Transmission Constipation
Official title: The Second Hospital Affiliated Anhui University of Chinese Medicine
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Slow Transmission Constipation
Keywords: slow transmission constipation
Lead sponsor: The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2024-11-08
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: slow transmission constipation
Primary purpose: TREATMENT

Brief summary: Objective To examine the therapeutic effect and safety of non-invasive auricular acupoint stimulation application on patients with slow transmission constipation.

Methods In a randomized clinical trial, 60 patients diagnosed with slow transit constipation (STC), ranging in age from 40 to 75 years, were allocated into two distinct cohorts: a study group and a control group. The study group, comprising 30 individuals, received a combination therapy of non-invasive auricular acupoint stimulation and prucapride, while the control group, also consisting of 30 patients, was administered prucapride as a monotherapy. To assess the efficacy of the interventions, various parameters were monitored, including serum levels of Neuropeptide Y (NPY), nitric oxide (NO), fecal water content, and gastrointestinal (GI) transit. The comparative therapeutic outcomes were determined by calculating symptom scores.


Eligibility criteria: Inclusion Criteria: ① Conformity to the diagnostic benchmarks for STC as delineated in the Rome IV criteria; ② Absence of ingestion of any medication influencing gastrointestinal motility within the preceding three months; ③ Provision of informed consent after a comprehensive understanding of the study's objectives; ④ An age range of 40 to 75 years.

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Exclusion Criteria: ① Withdrawal from the therapeutic regimen; ② Auricle or ear canal pathologies; ③ Organic defecation disorder; ④ Pregnant or lactating.

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Primary outcomes:
measure: overall efficacy rate
timeFrame: From enrollment to the end of treatment at one week
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01505582: Inspiratory Muscle Training and Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inspiratory Muscle Training
Low Back Pain
Respiratory Disorders
Lead sponsor: KU Leuven
Sponsor class: OTHER
Collaborators: name: Universitaire Ziekenhuizen KU Leuven
First posted: 2012-01-06
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Proprioceptive weighting changes may explain differences in postural control performance. In addition, the respiratory movement has a disturbing effect on postural balance. Postural balance seems to be impaired in individuals with respiratory disorders. Besides the essential role of respiration, the diaphragm may also play an important role in the control of the trunk and postural balance. Deficits in proprioception are found in a subgroup of patients with low back pain. In addition, disorders of respiration have been identified as strongly related to low back pain.

The aim of the study is to clarify whether inspiratory muscle training has a positive effect on proprioceptive postural control in individuals with recurrent low back pain.


Eligibility criteria: Inclusion Criteria individuals with low back pain:

* Age: 18-45 years old
* At least 1 year of low back pain with/without referred pain in buttock/thigh
* At least 3 episodes of disabling low back pain
* At least a score of 20% on the Oswestry Disability Index
* Willingness to sign the informed consent

Exclusion Criteria:

* History of major trauma and/or major orthopedic surgery of the spine, the pelvis or the lower quadrant
* One of the following conditions: Parkinson, multiple sclerosis, stroke, history of vestibular disorder, respiratory disease, pregnancy
* Radicular symptoms
* Not Dutch-speaking
* Strong opioids
* Neck pain
* Smoking history

Primary outcomes:
measure: Proprioceptive postural control
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Katholieke Universiteit Leuven
Study officials:
affiliation: KU Leuven
name: Simon Brumagne, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: KU Leuven
name: Thierry Troosters, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: KU Leuven
name: Roeland Lysens, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Peter Van Wambeke, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Janssens L, Brumagne S, Polspoel K, Troosters T, McConnell A. The effect of inspiratory muscles fatigue on postural control in people with and without recurrent low back pain. Spine (Phila Pa 1976). 2010 May 1;35(10):1088-94. doi: 10.1097/BRS.0b013e3181bee5c3.
Clinical trial NCT04759482: Validation of a New Algorithm for Screening Sleep Apnea Syndrome From Electrocardiogram
Official title: Validation of an Innovative Algorithm for Screening Sleep Apnea Syndrome From an Electrocardiographic Recording During Sleep
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sleep Apnea
Keywords: sleep
electrocardiogram
screening
apnea
polysomnography
algorithm
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2021-02-18
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient refered to the CSMR, for which sleep apnea are supected

Brief summary: Sleep apnea syndrome is a prevalent disease, recognized as an independant risk factor for cardiovascular diseases The gold standard for the diagnosis of sleep apnea is the polysomnography. But polysomnography is time-consuming and very expensive. We developed an algorithm for screening sleep apnea from electrocardiographic signal. This would lead to the simplification of screening sleep apnea by using a two-channels recording device and computerizing the scoring of respiratory events. The validation of the algorithm will consist in comparing the number of apnea and hypopnea per hour of sleep (AHI) detected by the algorithm from the electrocardiographic signal recorded during a standard polysomnography in the Center for Sleep Medicine and Research in Nancy, with the AHI resulted from the standard interpretation of the same polysomnography by experts in sleep scoring (gold standard).


Eligibility criteria: Inclusion Criteria:

* all patients with a polysomnography recorded in the Center for Sleep Medecine and Research (CSMR) in Nancy from january 2019 and june 2020
* results of standard interpretation of polysomnography giving a number of hypopnea and apnea per hour of sleep (AHI) superior to 5

Exclusion Criteria:

* refusal to participate

Primary outcomes:
measure: Concordance of the number of sleep hypopnea and apnea between an algorithm computerizing the electrocardiographic signal and the standard interpretation of the polysomnography by an expert in sleep scoring (gold standard)
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Research and Innovation Department
name: El Mehdi Siaghy
role: STUDY_CHAIR
References:
Clinical trial NCT03571282: Safety and Effectiveness of Intravitreal Conbercept for Exudative Circumscribed Choroidal Haemangioma
Official title: Safety and Effectiveness Study of Intravitreal Conbercept Injection for Exudative Circumscribed Choroidal Haemangioma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Circumscribed Choroidal Haemangioma
Keywords: conbercept
circumscribed choroidal haemangioma
safety
effectiveness
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2018-06-27
Enrollment: 50
Sex: ALL
Minimum age (years): 15
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This prospective clinical trial aims to evaluate the safety and effectiveness study of intravitreal conbercept injection for exudative circumscribed choroidal haemangioma.

Detailed description: This prospective clinical trial aims to evaluate the safety and effectiveness study of intravitreal conbercept injection for exudative circumscribed choroidal haemangioma: (1)To evaluate therapeutic effect (including both anatomical and functional responses to intravitreal conbercept injection) of intravitreal conbercept injectionfor exudative circumscribed choroidal haemangioma; (2)To evaluate the safety (including side effects of the eye as well as side effects of system) of intravitreal conbercept injection for exudative circumscribed choroidal haemangioma.

Eligibility criteria: Inclusion Criteria:

* 1) patients with circumscribed choroidal haemangioma who was diagnosed using ophthalmoscopy, fluorescein/indocyanine green angiography, and ultrasonography; 2) presence of reduced visual acuity or metamorphopsia; and 3) subretinal fluid involving the fovea.

Exclusion Criteria:

* patients with abnormal liver function test results, liver disease, porphyria, or previous treatment for circumscribed choroidal haemangioma.

Primary outcomes:
measure: Best-corrected visual acuity
timeFrame: half a year
Secondary outcomes:
measure: Central foveal thickness
timeFrame: half a year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Chenjin Jin, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05061082: Genomic Evolution of Metastasis in Gastric Cancer
Official title: Genomic Evolution of Metastasis in Gastric Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gastric Cancer
Metastasis
Keywords: Gastric Cancer
Metastasis
Lead sponsor: University Medical Center Ho Chi Minh City (UMC)
Sponsor class: OTHER
First posted: 2021-09-29
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with metastatic gastric adenocarcinoma

Brief summary: The aim of this study is to track tumor evolution of regional and distant metastases in gastric cancer using the Next Generation Sequencing technologies.

Detailed description: Gastric cancer is the fourth most common cancer in Vietnam with high mortality rate. Metastasis is the leading cause of death in gastric cancer patients, with median overall survival of less than 1 year. Currently, there is no effective treatment because the molecular mechanism of metastasis remains unclear. The aim of this study is to use advanced NGS technologies to dissect the genomic changes (genetic, epigenetic and transcriptional changes) of the primary tumor and associated metastatic sites of the same patients. With that, the investigators can reconstruct the clonal evolution from primary tumor to metastasis, identify key pathways governing metastasis development that can be targeted for future therapeutic development.

Eligibility criteria: Inclusion Criteria:

1. Male or Female patients aged 18 years and older
2. Histologically proven primary gastric adenocarcinoma and clinical evidence of metastasis (N1-3M1)
3. Biopsies can be taken at multiple sites
4. No known other concomitant cancer diagnosis
5. Signed informed consent

Exclusion Criteria:

1. Gastric adnocarcinoma cannot be confirmed primary
2. Unable to undergo biopsy or surgery

Primary outcomes:
measure: Genetic and epigenetic changes of the tumor
timeFrame: 3 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Ho Chi Minh City
country: Vietnam
facility: University Medical Center Ho Chi Minh City
Study officials:
References:
Clinical trial NCT02099682: Long-term Use of Takepron Capsules on the Prevention of Recurrence of Gastric/Duodenal Ulcer in Patients Receiving Low-dose Aspirin
Official title: Takepron Capsules 15/ Orally Dispersing (OD) Tablets 15 Special Drug Use Surveillance Long-term Use Survey on the Prevention of Recurrence of Gastric/Duodenal Ulcer in Patients Receiving Low-dose Aspirin
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric or Duodenal Ulcers
Keywords: Pharmacological therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2014-03-31
Enrollment: 3366
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Gastric or duodenal ulcers

Brief summary: The purpose of this study is to investigate the safety and efficacy of long-term administration of lansoprazole (Takepron) for up to 12 months in the routine clinical setting in patients receiving low-dose aspirin

Detailed description: This is a special survey on long-term use (for up to 12 months) of lansoprazole (Takepron) to determine the incidence of adverse drug reactions in the routine clinical setting in patients receiving low-dose aspirin.

The usual adult dosage is 15 mg of lansoprazole administered orally once daily.

Eligibility criteria: Inclusion Criteria:

* (1) Patients with a history of gastric or duodenal ulcers (2) Patients requiring long-term use of low-dose aspirin (81-324 mg once daily) as prophylaxis for thromboembolism (3) Patients taking low-dose oral aspirin (81-324 mg once daily) at the start of administration of lansoprazole (including patients who start low-dose aspirin on the same day as the start of administration of lansoprazole)

Exclusion Criteria:

* (1) Patients with gastric or duodenal ulcer (in the active \[A1, A2\] or healing \[H1, H2\] stage if assessed endoscopically) at the start of administration of lansoprazole (2) Patients with active upper gastrointestinal hemorrhage at the start of administration of lansoprazole (3) Patients with contraindications for lansoprazole

Primary outcomes:
measure: Frequency of Adverse Drug Reactions
timeFrame: 12 months
Secondary outcomes:
measure: Presence or Absence of Endoscopic Examinations
timeFrame: From baseline to 12 months
measure: Presence of Gastric or Duodenal Ulcer
timeFrame: From baseline to 12 months
measure: Presence of Gastric or Duodenal Hemorrhagic Lesion
timeFrame: From baseline to 12 months
measure: Presence of Either Gastric/Duodenal Ulcer, or Gastric/Duodenal Hemorrhagic Lesion
timeFrame: From baseline to 12 months
measure: Treatment for Gastric/Duodenal Ulcer or Lesion
timeFrame: From baseline to 12 months
measure: Details of Treatment (Including Duplicates) for Gastric or Duodenal Ulcers or Hemorrhagic Lesions
timeFrame: From baseline to 12 months
measure: Treatment Outcome (Including Duplicates) for Gastric or Duodenal Ulcers or Hemorrhagic Lesions
timeFrame: From baseline to 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Takeda
name: Postmarketing Group Manager
role: STUDY_CHAIR
References:
Clinical trial NCT01250782: Effectiveness of Dipeptide N (2)-L-Alanyl-L-Glutamine in Trauma ICU Patients: Pilot, Prospective, Randomized and Double Blind Study.
Official title: Effectiveness of Dipeptide N (2)-L-Alanyl-L-Glutamine in Trauma ICU Patients: Pilot, Prospective, Randomized and Double Blind Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Trauma ICU Patients
Keywords: Glutamine, trauma patients, infections, mortality
Lead sponsor: Hospital Universitari Son Dureta
Sponsor class: OTHER
First posted: 2010-12-01
Enrollment: 150
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: Recent reports suggest that most beneficial results of glutamine have been obtained with the parenteral administration of high doses of glutamine (0.35 g/Kg/d) and in some special group of patients, such as traumatic patients. Nevertheless total parenteral nutrition is not often used in critically ill patients.

The endovenous administration of the the dipeptide N(2)-L-alanyl-L-glutamine in trauma ICU patients can reduce the number of infections, ICU length of stay and mortality.

This benefit can be achieved independently the type of nutrition (enteral or parenteral nutrition), being a pharmaconutrient.

Detailed description: Objective: To evaluate the efficacy of the endovenous administration endovenous glutamine to reduce the number of infectious complications, mortality and ICU length of stay in trauma ICU patients. To achieve this objective we have designed this pilot study to obtain the necessary data to design a bigger trial in the future.

Other objectives include:

* To evaluate the efficacy of glutamine in different patients regarding their severity: patients with an Injury Severity Score\> 25 and patients with lower plasma levels of glutamine.
* To registry the possible adverse events of the endovenous administration of glutamine.

Eligibility criteria: Inclusion Criteria:

* Moderate to severe trauma, as defined by an Injury Severity Score (ISS) \> 10 points were included in the study.
* Traumatic patients who required enteral or parenteral nutrition during the first 48 hours after hospital admission
* Written informed consent

Exclusion Criteria:

* patients whose life expectancy was less than 5 days,
* who were allergic to glutamine,
* Patients included in any other trial
* Cirrhotic patients (Child C)
* Chronic renal failure

Primary outcomes:
measure: Number of infections
timeFrame: ICU discharge (median ten days)
Secondary outcomes:
measure: ICU Mortality
timeFrame: ICU mortality measured at 1 month after hospital admission
measure: SAfety of endovenous administration
timeFrame: 5 days from the beginning of treatment
Other outcomes:
Locations:
city: Palma
country: Spain
facility: Hospital Universitario Son Dureta
state: Islas Baleares
Study officials:
References:
Clinical trial NCT04682782: Intraoperative Small-dose Esketamine Infusion for Pain Control in Burn Patients
Official title: Intraoperative Small-dose Esketamine Infusion for Pain Control in Burn Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Burns
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2020-12-24
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study aim to determine whether a small-dose esketamine infusion can be used for pain control in severe burn patients, and thereby reduce the total intra-operative opioid requirement. Secondary objectives are to determine whether this low-dose esketamine infusion will increase the stability of circulation.


Eligibility criteria: Inclusion Criteria:

* All intubated adult burn patients( age\>18 ), presenting to the operating room;
* Burn area\> 30%.

Exclusion Criteria:

* Allergy to Esketamine or benzodiazepines
* Esketamine or ketamine use in the preceding 24 hours
* Increased intracranial pressure
* Increased intraocular pressure
* Porphyria
* Thyroid disorders
* Seizures
* Acute myocardial ischemia
* Children (patients under age 18), prisoners, pregnant or breastfeeding women, patients with psychosis, patients with developmental delay, and any condition which, in the opinion of the investigator, would prevent full participation in this study or would interfere with the evaluation of the trial endpoints.

Primary outcomes:
measure: Intraoperative sufentanil
timeFrame: 24 hours
Secondary outcomes:
measure: Intraoperative blood pressure
timeFrame: 24 hours
measure: Intraoperative heart rate
timeFrame: 24 hours
measure: Intraoperative cardiac index
timeFrame: 24 hours
measure: Post-operative recovery time
timeFrame: 24 hours
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: 2nd affiliated hospital, School of Medicine, Zhejiang Universtiy, China
state: Zhejiang
Study officials:
affiliation: 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
name: Min YAN, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03668782: Cord Milking in Elective Cesarean Section
Official title: Efficacy of Umbilical Cord Milking in Elective Cesarean Section
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Placental Transfusion
Lead sponsor: Policlinico Abano Terme
Sponsor class: OTHER
First posted: 2018-09-13
Enrollment: 130
Sex: ALL
Minimum age (years): 1
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All women who presented for an elective cesarean section were screened for eligibility.

Brief summary: The objective of the study was to investigate the efficacy and safety of umbilical cord milking as compared with immediate cord clamping on placental transfusion, estimated by Δ hematocrit between cord blood at birth and capillary heel hematocrit at 48 hours of age, in elective cesarean delivered neonates.


Eligibility criteria: Inclusion Criteria: singleton low risk pregnancy, gestational age of 39 to 40/0 weeks confirmed by a first trimester ultrasound, no evidence of active labor, 18 years of age, and (5) a written consent given by the woman.

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Exclusion Criteria:maternal medical and obstetric complications, severe anemia, clotting disorders and suspected intrauterine growth restriction

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Primary outcomes:
measure: Placental transfusion
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Abano Terme
country: Italy
facility: Policlinico Abano Terme
Study officials:
References:
citation: Zanardo V, Guerrini P, Severino L, Simbi A, Parotto M, Straface G. A Randomized Controlled Trial of Intact Cord Milking versus Immediate Cord Clamping in Term Infants Born by Elective Cesarean Section. Am J Perinatol. 2021 Mar;38(4):392-397. doi: 10.1055/s-0039-1697673. Epub 2019 Oct 10.