louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00164801: Effect of GABAB Agonist on Visceral Hyperalgesia in NCCP patientsChinese?
Official title: Is Visceral Hyperalgesia the Culprit of Noncardiac Chest Pain in Chinese? Part 2: Effect of GABAB Agonist on Visceral Hyperalgesia in NCCP Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Non-Cardiac Chest Pain
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2005-09-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The effect of baclofen (GABAB agonist), diltiazem (muscle relaxant) and placebo will be compared in a double-blinded randomized study for the treatment of NCCP. Cerebral cortical, brainstem and spinal evoked potentials before and after treatment will be evaluated. Results of this study will shed lights on pathogenesis and treatment of NCCP in Chinese.We hypothesize that Baclofen alleviates visceral hyperalgesia in NCCP patients by suppressing afferent sensory pathway.


Eligibility criteria: Inclusion Criteria:

* Consecutive patients with monthly angina-like chest pain and negative coronary angiogram or scintigraphy
* Age between 18-70
* Gastroesophageal reflux disease
* Psychiatric illness
* Cerebrovascular accident
* Active peptic ulceration
* Heart failure or cardiac bradyarrhythmia
* Epilepsy
* Pregnancy or lactating female
* Previous hypersensitivity to muscle relaxant

Primary outcomes:
measure: Esophageal sensory and pain thresholds
Secondary outcomes:
measure: Symptom severity of chest pain at the end of treatment
measure: Evoked potential responses
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Endoscopy Centre, Prince of Wales Hospital
Study officials:
affiliation: Chinese University of Hong Kong
name: Justin CY CU, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05509101: Improving Myoelectric Prosthetic and Orthotic Limb Control
Official title: Improving Myoelectric Prosthetic and Orthotic Limb Control Using Predictive Regression Algorithms and High-count Surface Electrodes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hemiparesis
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2022-08-19
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The purpose of this study is to improve control of myoelectrically-controlled advanced orthotic devices (an exoskeleton device that use the body's muscle signals to drive movements of a robotic brace) by using advanced predictive decode algorithms, and the use of high count (\> 8) surface electromyographic (sEMG) electrodes.

Detailed description: This study looks to improve control of myoelectrically-controlled advanced powered orthoses (orthoses that use the body's muscle signals to drive movements of a robotic exoskeleton) by using advanced predictive decode algorithms, and the use of high count (\> 8) surface electromyographic (sEMG) electrodes.

Eligibility criteria: Inclusion Criteria:

* First-ever ischemic or hemorrhagic stroke
* Chronic Stroke (at least 6 months since onset)
* Chronic hemiparesis
* Functional range of motion for contralateral arm

Exclusion Criteria:

* Individuals who are currently Incarcerated

Primary outcomes:
measure: Box and Blocks Test (BBT)
timeFrame: while using the device (up to 2 hours)
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
References:
Clinical trial NCT04275401: Quantitative Evaluation of Muscle Tone Using Elastic Ultrasound
Official title: Study on Quantitative Evaluation of Muscle Tone Using Elastic Ultrasound
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Muscle Tone Increased
Ultrasonography
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2020-02-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: This study is expected to recruit 50 patients with clinical changes in flexion of the elbow flexor and 50 healthy subjects to participate in the study.

Brief summary: The test subjects were selected from patients with clinical manifestations in muscle tone and healthy volunteers. Elbow flexor is the main target muscle. Fifty patients and 50 healthy subjects were given three assessment methods to measure muscle tension: modified Ashworth rating scale, elastic ultrasound technology and surface electromyography, and the data obtained by these three methods will be statistically analyzed and discussed.


Eligibility criteria: Inclusion Criteria:

* There are clinical manifestations of changes in muscle tension of the elbow flexor group;
* Subject's diagnosis is clear;
* The degree of joint mobility meets the method of muscle tension assessment.

Exclusion Criteria:

* Has serious diseases such as heart, lung, liver, kidney, etc., cardiac function grade is greater than Grade I (NYHA), has symptoms and signs or examination results such as respiratory failure;
* History of muscle disorders;
* Recent (within 6 months) history of external injury, fracture or surgery of the limb;
* Are using drugs that affect muscle tone;
* Severe osteoporosis;
* Acute phase of inflammation
* Acute limb thrombosis of the subject;
* Pregnancy.

Primary outcomes:
measure: Modified Ashworth Scale
timeFrame: through study completion, an average of 1 year
measure: shear wave elastography
timeFrame: through study completion, an average of 1 year
measure: surface electromyography
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
Study officials:
References:
Clinical trial NCT02350101: Massive Transfusion Protocol With Coagulation Algorithm
Official title: Introduction of a Massive Transfusion Protocol - Evaluation Over Three Years
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bleeding
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2015-01-29
Enrollment: 243
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients needing massive transfusion (more than 10 RBCs)

Brief summary: In 2008 at the University Hospital Zurich (USZ) a massive transfusion protocol was introduced. Based on laboratory diagnostics and point of care (POC) devices including ROTEM.

Goal of this retrospective study is to evaluate the influence of this algorithm on coagulation, use of blood products, coagulation factors and ROTEM evolution.

Detailed description: In 2008 at the USZ a massive transfusion protocol was introduced. Based on laboratory diagnostics and POC (point of care) devices including ROTEM.

Goal of this retrospective study is to evaluate the influence of this algorithm on coagulation, use of blood products, coagulation factors and ROTEM evolution over three years (2008-2010)

Eligibility criteria: Inclusion Criteria:

* Massive transfusion

Exclusion Criteria:

* non

Primary outcomes:
measure: Coagulation in ROTEM
timeFrame: 3 years
Secondary outcomes:
measure: Transfusion needs
timeFrame: 3 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02460601: The Efficacy and Safety of Qizhiweitong Granule on Patients With Functional Dyspepsia in a Multi-center Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Functional Dyspepsia
Lead sponsor: Wuhan Union Hospital, China
Sponsor class: OTHER
First posted: 2015-06-02
Enrollment: 400
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 study aims to verify the efficacy and safety of Qizhiweitong granule on Chinese patients with functional dyspepsia diagnosed by the Rome III criteria. It includes two subtypes of functional dyspepsia, postprandial distress syndrome or abdominal pain syndrome.


Eligibility criteria: Inclusion Criteria:

1. patient with written ICF signed
2. patient with functional dyspepsia diagnosed by the Rome III criteria
3. age between 18y and 65y;male or female.
4. patient without gastric ulcers, erosive gastritis or other gastric organic diseases according to the endoscopy in the past one year in the hospital
5. patient without hepatobiliary and pancreatic diseases according to B-ultrasoundin the past one year in the hospital
6. patient with normal ECG (QT interval in the normal range) within one month prior to enrollment in this center
7. patient with symptoms of only one subtype of functional dyspepsia

Exclusion Criteria:

1. history of abdominal surgery;
2. take drugs related to gastrointestinal motility or gastric acid secretion and gastric acid drugs, anti-Helicobacter pylori drugs within 5 days of inclusion
3. suffering from hepatobiliary and pancreatic diseases with B ultrasound
4. suffering from high blood pressure and uncontroled hypertension
5. diabetes mellitus
6. have history of thyroid disease, systemic sclerosis, systemic lupus erythematosus
7. severe mental disorders
8. pregnant women, breastfeeding women or those who plan to become pregnant
9. allergy to Qizhiweitong particle
10. have symptoms of both subtypes of functional dyspepsia

Primary outcomes:
measure: symptom severity score
timeFrame: 3 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Su Q, Chen SL, Wang HH, Liang LX, Dai N, Lyu B, Zhang J, Wang RQ, Zhang YL, Yu Y, Liu JS, Hou XH. A Randomized, Double-Blind, Multicenter, Placebo-Controlled Trial of Qi-Zhi-Wei-Tong Granules on Postprandial Distress Syndrome-Predominant Functional Dyspepsia. Chin Med J (Engl). 2018 Jul 5;131(13):1549-1556. doi: 10.4103/0366-6999.235118.
Clinical trial NCT04171401: Limits of Stability in Sitting in Healthy Controls and Participants Post Stroke
Official title: Maximum Weight-shifts in Sitting in Non-ambulatory People With Stroke Are Related With Trunk Control and Balance in Sitting and Standing
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Balance; Distorted
Lead sponsor: KU Leuven
Sponsor class: OTHER
Collaborators: name: Universitaire Ziekenhuizen KU Leuven
First posted: 2019-11-20
Enrollment: 49
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The study population consists of patients post stroke which are severly affected and are unable to walk without help of one or two persons who help cary their weight or control their balance. Participants are in the subacute phase post stroke and are admitted to a rehabilitation programme at the UZ Pellenberg.

Healthy controls were also included in this study.

Brief summary: In this cross-sectional study we will compare the limits of stability in non-ambulatory participants post stroke compared to healthy controls. This will be done by placing participants in a seated position on a force platform, that will measure centre of pressure displacements during a leaning task in multiple directions. The results of the limits of stability test will be compared to standard clinical Measures of trunk control and functional balance, to see if there is a relationship between both ways of measuring. And how balance and trunk control are affected in the subacute stroke population.


Eligibility criteria: Inclusion Criteria Participants post Stroke:

* a stroke with clear hemiplegia (a previous stroke is accepted when complete recovery was achieved)
* being a patient at the UZ Pellenberg
* Functional Ambulation Catergory of two or less
* to be able to sit independently for 2 minutes
* to be cooperative enough to fulfill multiple Evaluations and tests
* to be able to understand simple instructions and be able to execute those.

Exclusion Criteria Participants post Stroke:

* to have musculoskeletal and/or other neurological disorders that could influence the protocol
* severe communication, memory or language disorders that could disturb the understanding of the research protocol.
* no signed informed consent

Inclusion criteria healthy controls:

* Age above 50
* to be able to stand independently for 2 minutes

Exclusion criteria healthy controls:

* a disorder that could influence balance capabilities
* Berg Balance Scale less than 50 Points
* no signed informed consent

Primary outcomes:
measure: Limits of Stability Testing
timeFrame: Baseline
measure: Berg Balance Scale
timeFrame: Baseline
measure: Trunk Impairment Scale
timeFrame: Baseline
measure: Trunk Control Test
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: KU Leuven
name: Geert Verheyden
role: STUDY_DIRECTOR
References:
Clinical trial NCT00211601: Study of Chemotherapy and Patient Health Outcomes for Nausea and Emesis (0000-041)
Official title: Study of Chemotherapy and Patient Health Outcomes for Nausea and Emesis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chemotherapy Induced Nausea and Vomiting
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2005-09-21
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to assess whether timely feedback to providers on patient experiences with delayed chemotherapy induced nausea and vomiting (CINV) lead to differences in patient outcomes for subsequent cycles.


Eligibility criteria: Inclusion Criteria:

* Highly or moderately emetogenic chemotherapy planned for at least 2 cycles

Exclusion Criteria:

* Concurrent other anti-cancer therapy (e.g. radiation, hormone, etc.); vomiting during the 24 hours prior to first chemotherapy cycle; having a disease/condition or taking medication that may cause emesis

Primary outcomes:
measure: CINV at the delayed phase during cycle 2
Secondary outcomes:
measure: Treatment for CINV
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT06166667: Effect of Fecal Capsule on Chronic Kidney Disease (CKD)
Official title: Effect of Fecal Capsule on Chronic Kidney Disease (CKD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Insufficiency, Chronic
Lead sponsor: Shanxi Provincial People's Hospital
Sponsor class: OTHER_GOV
First posted: 2023-12-12
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: By collecting blood, urine and stool samples before and after oral Enterobacteriaceae capsule (FMT) from CKD subjects, we investigated the role and related mechanisms of gut microecology in the development of CKD using a combination of metagenomic sequencing, metabolomic analysis and flow cytometry.

Detailed description: Patients involved in the trial received 16 capsules of Enterobacteriaceae (one course) on days 1, 8, and 15, which were provided by Dongyuan Yikang company. Patients were prohibited from taking antibiotics such as amoxicillin and Cefalexin during the trial.

Eligibility criteria: Inclusion Criteria:

1. Subjects: Patients with chronic kidney disease (CKD)
2. GFR ≥ 30 ml / min, or serum creatinine ≤ 442 μ mol/L
3. Negative urine pregnancy test and no plans for pregnancy for the next 18 months, enabling effective contraception
4. Age: 18-70 years
5. Signed informed consent for clinical studies informed consent for treatment of patients with flora transplantation (FMT)

Exclusion Criteria:

1. Had taken antibiotics for nearly 14 days
2. Active systemic infections or severe infections within 1 month prior to enrollment, including HIV, HBV, HCV
3. White blood cell count \< 3.0x109/l; Platelet count \< 80x109 / L, or had other hematologic diseases
4. Presence of malignancy and other diseases with expected survival time \< 3 months
5. Presence of IBD, CDI, or gastrointestinal tumors
6. Presence of active gastrointestinal bleeding or acute and chronic gastrointestinal inflammation
7. Were or had undergone FMT
8. Psychosis and cognitive impairment
9. History of alcohol or drug abuse
10. Pregnant or lactating women
11. Difficult to follow-up
12. Difficult or unwilling to cooperate

Primary outcomes:
measure: Abundance of gut microbiota
timeFrame: 6 months after the end of the trial
Secondary outcomes:
measure: 24-hour urine protein quantitative change rate
timeFrame: 6 months after the end of the trial
measure: the density of immune cells
timeFrame: 6 months after the end of the trial
measure: Cytokine concentration
timeFrame: 6 months after the end of the trial
Other outcomes:
Locations:
city: Taiyuan
country: China
facility: Shanxi Provincial People's Hospita
state: Shanxi
Study officials:
affiliation: Shanxi Provincial People's Hospital (Fifth Hospital) of Shanxi Medical University
name: Yafeng Li, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03128567: Deep Brain Stimulation for Patients With Parkinson's Disease.
Official title: Effets de la Stimulation cérébrale Profonde Chez Les Patients âgés Avec Maladie de Parkinson : Essai contrôlé randomisé Multicentrique
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson Disease
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
First posted: 2017-04-25
Enrollment: 10
Sex: ALL
Minimum age (years): 69
Maximum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Parkinson's disease

Brief summary: Deep brain stimulation of the sub thalamic nucleus (STN-DBS) is an efficient treatment to improve motor and non motor signs of Parkinson's disease (PD). In people aged more 70 years, an increased rate of side effects such as post-operative cognitive decline and/or postural instability with falls has been suspected with less improvement in the quality of life. Here, Investigators aim further explore the effects of STN-DBS in 50 patients with PD people aged more 69 years in a randomized parallel controlled study.

Detailed description: The effects of combined bilateral deep brain stimulation of the subthalamic nucleus and medical treatment on the quality of life will be evaluated in 25 PD patients aged more 69 years in comparison to 25 PD patients aged more 69 years that only received medical drug treatment.

Eligibility criteria: Inclusion Criteria:

* Parkinson's disease
* disease duration \> 5 years
* levodopa related motor complications
* dopasensitivity \> 50%
* signed informed written consent
* medical social insurance

Exclusion Criteria:

* dementia
* contra-indication to neurosurgery

Primary outcomes:
measure: PDQ-39 Quality of life questionnary
timeFrame: Quality of life one year after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Service d'EFSN, Hôpital Pellegrin
city: Lille
country: France
facility: Hôpital Roger Salengro - CHRU de Lille Service de Neurologie et Pathologie du Mouvement
city: Lyon
country: France
facility: Hôpital Neurologique Pierre Wertheimer, Service de Neurologie
city: Paris
country: France
facility: Département des maladies du Système Nerveux, Hôpital Pitié-Salpétrière
city: Poitiers
country: France
facility: Service de Neurologie, Pôle Neurosciences, CHU de Poitiers
city: Rouen
country: France
facility: CHU Charles Nicolle
city: Toulouse
country: France
facility: Centre d'Investigation Clinique - CIC 1436. CHU PURPAN. Hôpital Pierre Paul Riquet
Study officials:
References:
Clinical trial NCT03252067: Tear Concentrations and Pharmacokinetics of Azithromycin Eye Drops in Healthy Volunteers
Official title: Tear Concentrations and Pharmacokinetics of Azithromycin Following Topical Administration of a Single Dose of Azithromycin Eyedrops in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Pharmacokinetics
Keywords: Azithromycin eyedrops, pharmacokinetics, tears
Lead sponsor: Beijing Tongren Hospital
Sponsor class: OTHER
Collaborators: name: Grand Pharmaceutical (China) Co., Ltd.
First posted: 2017-08-17
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate azithromycin tear concentrations after one drop of azithromycin eyedrops (2.5ml/25mg) in healthy volunteers.

Detailed description: In this randomized, open, single-center study, 42 healthy volunteers will receive one drop of azithromycin into each eye. Azithromycin tear concentrations will be measured by LC-MS/MS at seven time points for 24 hours. Tolerability is evaluated.

Eligibility criteria: Inclusion Criteria:

* 18 to 45 years old, male or female;
* BMI in the range of 19 to 24;
* eyes corrected visual acuity should be ≥ 1.0, intraocular pressure, slit lamp and fundus examination were normal, tear secretion function is normal;
* Good compliance and voluntarily signed consent.

Exclusion Criteria:

* Have eye disease or systemic disease;
* physical examination, laboratory tests, ECG and chest X-ray examination abnormalities and has clinical significance;
* HBsAg, anti-HCV, anti-HIV and TPPA positive;
* those who used eye drops two weeks before the test and who used any dosage form of azithromycin;
* known to azithromycin or macrolide-related varieties of allergies or serious adverse reactions;
* need to wear contact lenses during the test;
* history of internal surgery or laser surgery history;
* participated in other drug clinical trials in the past three months;
* pregnant women and lactating women, or in the growth period without taking effective contraceptive measures, menstrual period women;
* mental illness or alcohol, history of drug abuse or inability to collaborate;
* Any other circumstances that the investigators consider are unfit to participate in this study.

Primary outcomes:
measure: the maximum concentration (Cmax)
timeFrame: The tear samples are taken at 7 time points after administration,including 10 minutes,half hour,2 hours,4 hours,8 hours,12 hours and 24hours.
measure: area under the curve (AUC)
timeFrame: The tear samples are taken at 7 time points after administration,including 10 minutes,half hour,2 hours,4 hours,8 hours,12 hours and 24hours.
Secondary outcomes:
measure: AEs
timeFrame: 24 hours
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tongren Hospital
state: Beijing
Study officials:
References: