louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06206447: Comparison of Short-term Application of Dialysis Catheter With Tunnel-cuffed Catheter Versus Non-ccuffed Catheter: a Multicenter Prospective Cohort Study
Official title: Comparison of Short-term Application of Dialysis Catheter With Tunnel-cuffed Catheter Versus Non-ccuffed Catheter: a Multicenter Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Clarify the Difference of Short-term Infection Rate Between Diffrent Catheter
Lead sponsor: Beijing Friendship Hospital
Sponsor class: OTHER
First posted: 2024-01-16
Enrollment: 200
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: Patient who needs hemodialysis with catheter in right internal jugular vein

Brief summary: Through a multi-center, prospective cohort study, hemodialysis patients with right internal jugular vein catheterization were collected and divided into tunnel-cuffed catheter group and non-cuffed catheter group according to the types of catheterization. The incidence of catheter infection, thrombosis and other complications between the two groups were compared.To clarify the difference of short-term infection rate between tunnel-cuffed catheter and non-cuffed catheter.


Eligibility criteria: Inclusion Criteria:

* ① Age ≥18 years; ② Uremia, clinical evaluation needs to start hemodialysis immediately, and the right internal jugular vein catheterization is the vascular access for the subjects. ③ Subjects who underwent right internal jugular vein catheterization on regular hemodialysis due to poor internal fistula function and the recovery time of internal fistula was ≥4 weeks; ④ Patients with AKI who need renal replacement therapy and underwent catheterization in the right internal jugular vein, and the renal replacement time is ≥4 weeks.

Exclusion Criteria:

* ① Subjects with previous history of central venous thrombosis, stenosis, infection, etc. ② The subjects were not dialyzed three times a week; ③ Other subjects with central venous catheterization, including left internal jugular vein, femoral vein and subclavian vein; ④ Those who take immunosuppression for a long time.

Primary outcomes:
measure: Cumulative incidence of catheter infection within 3 months after catheterization
timeFrame: within 3 months after catheterization
Secondary outcomes:
measure: Cumulative incidence of catheter infection within 2 months after catheterization
timeFrame: within 2 months after catheterization
measure: Cumulative incidence of catheter infection within 1 months after catheterization
timeFrame: within 1 months after catheterization
Other outcomes:
measure: The incidence of catheter dysfunction
timeFrame: within 3 months after catheterization
Locations:
city: Beijing
country: China
facility: Beijing Friedship Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT02441647: Clinical Study to Prove Safety in Use (Irritability and Sensitization in Genital Mucosa) of an Intimate Lubricating Gel
Official title: Clinical Study to Prove Safety in Use (Irritability and Sensitization in Genital Mucosa) of an Intimate Lubricating Gel
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Female Dry Genital Mucosa
Lead sponsor: Kley Hertz S/A
Sponsor class: INDUSTRY
First posted: 2015-05-12
Enrollment: 33
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this study is to check the safety under normal conditions of use through the emergence of signs of irritability and sensitization of the genital mucosa.


Eligibility criteria: Inclusion Criteria:

* Female
* Age between 25 to 55 years old
* Regular Menstrual Cycle
* Intact skin in product analysis área
* No prior reactions to topical products
* Being a user of products from the same category
* Reading, understanding, agreement and signature of the informed consent form

Exclusion Criteria:

* Pregnancy or risk of pregnancy
* Lactation
* Use of anti-inflammatory and immunosuppressive from 30 days up to three months prior to selection;
* Diseases that cause imune suppression;
* Endocrine disorders such as thyroid, ovarian or adrenal gland disorders;
* Any infection in the region where the product will be analyzed diagnosed at enrollment;
* Other conditions considered by the investigator physician as reasonable for the disqualification of the individual's participation in the study.

Primary outcomes:
measure: Emergence of signs of irritability and sensitization in the genital mucosa through Wilcoxon test
timeFrame: 40 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06093347: Central Apnoea Monitor Study
Official title: Feasibility Study to Evaluate a New Wearable Wireless Device for Monitoring Central Apnoeas in Infants and Children
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sleep Apnea
Lead sponsor: Sheffield Children's NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Sheffield Hallam University
First posted: 2023-10-23
Enrollment: 15
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children admitted to the Sleep Unit at Sheffield Children's Hospital with suspected sleep apnoea

Brief summary: An initial small study on 15 children that are already being investigated for central sleep apnoea in the sleep unit at Sheffield Children's Hospital. The central apnoea monitor will be placed around the child's abdomen overnight alongside the sensors already being used for the clinical sleep study and the signals from the two systems will be compared to evaluate the accuracy of the new device.


Eligibility criteria: Inclusion Criteria:

* Patients who have been referred for a cardio-respiratory polygraphy sleep study.
* Patients aged 1 month up to 5 years old.

Exclusion Criteria:

* Subjects whose parents/legal guardians/carers are not fluent in English, or who have special communication needs.
* Child anticipated to become distressed with additional sensor.
* Child too clinically unwell to take part (as decided by clinical staff).

Primary outcomes:
measure: The accuracy of the system in 15 patients, when compared with the gold standard measurement system
timeFrame: 24 hours
measure: The acceptability of the sensor to the child as viewed by the parent (and child)
timeFrame: End of study
Secondary outcomes:
Other outcomes:
Locations:
city: Sheffield
country: United Kingdom
facility: Clinical Research Facility, Sheffield Children's Hospital
Study officials:
References:
Clinical trial NCT00938847: Bone Marrow Derived Mononuclear Cells For Myocardial Regeneration
Official title: Bone Marrow Derived Mononuclear Cells For Myocardial Regeneration in Early Left Ventricular Dysfunction After Acute Myocardial Infarction And Successful Percutaneous Coronary Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Left Ventricular Dysfunction
Keywords: left ventricular dysfunction
myocardial infarction
left ventricular dysfunction (LVDF) after acute myocardial infarction
Lead sponsor: Asklepios proresearch
Sponsor class: INDUSTRY
Collaborators: name: Cordis Corporation
First posted: 2009-07-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Evaluative pilot study for safety and feasibility with administration of autologous bone bone marrow derived mononuclear cells by endoventricular catheter into the normal border zone fo the ischemic lesion.


Eligibility criteria: Inclusion Criteria:

* LVEF \<40%
* PCI at latest 6 hours after infarction
* BMI \>20 kg/m² and \<30 kg/m²

Exclusion Criteria:

* PCI elder than 14 days
* relevant valvular disease
* left ventricular dysfunction caused by other reasons than ischemic cardiomyopathy
* history of stroke, chronic atrial fibrillation, multivessel disease, thromboembolic event
* scheduled for CABG
* DM Type 1 \& extensive hypercholesterinemia
* pacemaker
* systemic disease
* Pregnancy

Primary outcomes:
measure: Demonstration of safety and feasibility of BM-MNC treatment. Investigation of the suitability of endocardial left ventricular electromechanical mapping (LVEMM) with NOGA as endpoint for myocardial regeneration.
timeFrame: 12 months
Secondary outcomes:
measure: Collection of first evidence on the best type and time points for the determination of myocardial regeneration by NOGA and other parameters.
timeFrame: 12 months
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Asklepios Klinik St. Georg, Departement of Cardiology
Study officials:
affiliation: Asklepios Klinik St. Georg, Departement of Cardiology
name: Karl-Heinz Kuck, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01929447: Evaluation of WP200 With the Unified Probe (WP200U)
Official title: A Prospective, Comparative Study to Evaluate the Watch-PAT200 (WP200) With the Unified Probe (WP200U) Compared to the Currently Used Configuration of WP200 With the Nonin Oximetry Module
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep Disorders
Keywords: sleep disorders
sleep apnea
ambulatory device
WatchPAT
Lead sponsor: Itamar-Medical, Israel
Sponsor class: INDUSTRY
First posted: 2013-08-28
Enrollment: 75
Sex: ALL
Minimum age (years): 5
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects, adults and children, with suspected sleep disorders who are referred to a sleep study and are willing to participate in this clinical study.

Additional non selective volunteers who are willing to participate in this clinical study and consent to undergo an overnight sleep study at their home.

Brief summary: The prevalence of OSAS is estimated at 2% and 4% for adult women and men respectively, most of whom are undiagnosed and untreated. The severity of the disorder is expressed by the Apnea Hypopnea Index (AHI) which is the number of Apnea/Hypopnea episodes per hours of actual sleep and the Respiratory Disturbances Index (RDI) which is an extended index incorporating in addition to the previous episodes also respiratory effort related arousal episodes. The high cost of in-lab full night PSG, together with long waiting lists for sleep studies, have led to the development of a variety of ambulatory sleep study systems.

The primary objective of the study is to evaluate the newly developed WP200 with the unified probe (WP200U) compared to the currently used configuration of WP200 that uses an incorporated Nonin oximetry module in the sleep lab or in the home sleep environment.


Eligibility criteria: Inclusion Criteria:

* Age between 5-90
* Subjects that are able to read understand and sign the informed consent form of the study or by parents of subjects that are less than 18 years of age that are either referred or volunteering to undergo an overnight sleep study in the clinical sleep laboratory or at home

Exclusion Criteria:

* Permanent pacemaker.
* Severe lung disease.
* Severe peripheral neuropathy.
* Finger deformity that precludes adequate sensor appliance.
* Using one of the following medications: short/Long acting nitrates (less than 3 hours before the sleep study) or alpha-adrenergic receptor blockers (less than 24 hours before the sleep study).

Primary outcomes:
measure: Sleep respiratory parameters
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Carmel Medical Center
Study officials:
References:
Clinical trial NCT01726647: Metabolism Associated With Abdominal Fat Mass Distribution
Official title: Metabolism Associated With Abdominal Fat Mass Distribution
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obese
Keywords: obese women
fat mass distribution
Metabolomic profiles
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
Collaborators: name: University of Lausanne Hospitals
First posted: 2012-11-15
Enrollment: 40
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Obese women

Brief summary: Objectives:

The primary objective of this clinical trial is to characterize metabolic signatures associated with abdominal fat distribution in 40 women with different BMI 29-40 and different abdominal distribution of fat (visceral vs. sub-cutaneous fat).

No intervention with a product is planned. The subjects will be given one high fat meal with commercial products (eggs, milk, cream, bread, fruits, cheese and cheese) on one test day to test the post-prandial metabolic response.


Eligibility criteria: Inclusion Criteria:

* BMI 29-40 kg/m2
* Aged 25-45

Exclusion Criteria:

* Diagnosed metabolic disorder such as Diabetes type 1 and 2, cardiovascular disease, metabolic syndrome
* Pregnancy
* Any pathology (infectious or other) having required an antibiotic therapy within 1 month prior to the beginning of the study.
* Any therapy (contraception apart) within the run-in period of one week before the test day.
* Subject who cannot be expected to comply with treatments and measures.
* Subject who is affected by any specific eating disorder
* Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study.
* Subjects having recently undergone a weight loss of more than 3 kilos during the last 3 months

Primary outcomes:
measure: Metabolic plasma, urine and faeces profiles as a function of fat mass distribution
timeFrame: Changes from baseline in metabolic profiles at one day following fat meal intake
Secondary outcomes:
measure: Insulin sensitivity
timeFrame: Measured on the day before the fat meal intake
measure: Basal Energy Expenditure
timeFrame: Basal Energy Expenditure is measured on the day preceding the fat meal intake
Other outcomes:
Locations:
city: Lausanne 26
country: Switzerland
facility: Nestlé Clinical Development Unit / Metabolic Unit
city: Lausanne
country: Switzerland
facility: University Hospitals, Service of endocrinology, diabetology, and metabolism
Study officials:
affiliation: University Hospitals of Lausanne
name: Vittorio Giusti, MD, PD/MER
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01830647: An Observational Study of Avastin (Bevacizumab) in Patients With Metastatic Cancer of the Colon or Rectum
Official title: Non-interventional Local Study to Describe the Safety, Tolerability and Efficacy of Bevacizumab in Combination With Standard Chemotherapy Regimens as First Line in Patients With Metastatic Cancer of the Colon or the Rectum
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2013-04-12
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with metastatic cancer of the colon and/or rectum

Brief summary: This prospective observational study will evaluate the safety and efficacy of first-line Avastin (bevacizumab) in combination with standard chemotherapy in routine clinical practice in patients with metastatic cancer of the colon and/or rectum. Patients will be followed for the duration of their treatment and a 30-day follow-up after the last dose of study drug.


Eligibility criteria: Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Histologically or cytologically confirmed carcinoma of the colon and/or rectum with evidence of metastases
* At least one measurable metastatic lesion (as per RECIST criteria)
* Life expectancy of \> 12 weeks
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Adequate hematological, renal and liver function

Exclusion Criteria:

* Prior chemotherapy for metastatic disease
* Clinically significant cardiovascular disease
* Ongoing treatment with aspirin (325 mg/day) or other medications known to predispose for gastrointestinal ulceration
* Participation in an investigational trial in the previous 3 months
* Pregnant or lactating women
* History of thrombotic or haemorrhagic disorders
* Evidence of bleeding diathesis or coagulopathy
* Uncontrolled hypertension
* Known hypersensitivity to Avastin and any of its excipients, or any of the chemotherapies
* Evidence of any disease or disorder that contraindicates the use of an investigational drug or puts the patient at high risk for treatment-related complications

Primary outcomes:
measure: Safety: Incidence of adverse events
timeFrame: approximately 3.5 years
Secondary outcomes:
measure: Efficacy: Time to disease progression
timeFrame: approximately 3.5 years
Other outcomes:
Locations:
city: Podgorica
country: Montenegro
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT00976547: Correlation Analysis of Hearing Thresholds, Validated Questionnaires and Psychoacoustic Measurements in Tinnitus Patients
Official title: Correlation Analysis of Hearing Thresholds, Validated Questionnaires and Psychoacoustic Measurements in Tinnitus Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tinnitus
Hearing Loss
Depression
Keywords: tinnitus
depression
audiometry
measurement
Lead sponsor: Faculdade de Medicina de Valenca
Sponsor class: OTHER
First posted: 2009-09-14
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 48 tinnitus patients sensorineural hearing losses

Brief summary: Objective: To evaluate the correlation between audiometric thresholds, pitch matching (PM), minimum masking level (MML), Tinnitus Handicap Inventory (THI) and the Beck Depression Inventory (BDI) in tinnitus patients.

Subjects: 48 patients with tinnitus as the main complaint from OTOSUL, Otorrinolaringologia Sul-Fluminense, Volta Redonda, RJ, Brasil and Centro de Tratamento e Pesquisa em Zumbido, Belo Horizonte, MG, Brasil.

Method: Subjects performed tonal audiometry, Pitch Matching (PM) and Minimum Masking Level (MML) for tinnitus. They also fulfilled the Tinnitus Handicap Inventory (THI) and Beck Depression Inventory (BDI). Data was statistically compared for correlation between audiometric thresholds, psycho-acoustic measures and questionnaires.


Eligibility criteria: Inclusion Criteria:

* tinnitus for more than 6 months
* sensorineural hearing loss
* normal otoscopy

Exclusion Criteria:

* conductive or mixed hearing losses
* A-r, A-d, B and C tympanograms
* tinnitus treatment in the last 6 months
* pregnant woman
* Vestibular Schwannoma

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Belo Horizonte
country: Brazil
facility: Centro de Diagnóstico e Tratamento do Zumbido
state: MG
city: Volta Redonda
country: Brazil
facility: OTOSUL,Otorrinolaringologia Sul-Fluminense
state: RJ
Study officials:
affiliation: OTOSUL, Faculdade de Medicina de Valença
name: Ricardo R Figueiredo, MDMSc
role: STUDY_CHAIR
References:
Clinical trial NCT04721847: Pain Neuroscience Education in Diabetic Neuropathy
Official title: Effects of Pain Neuroscience Education in Diabetic Neuropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Neuropathic
Diabetic Nephropathy
Keywords: Pain
Neuropathy
Diabetes
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2021-01-25
Enrollment: 74
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine the effects of Pain Neuroscience Education in Diabetic Neuropathy

Detailed description: Pain neuroscience education (PNE) has shown to have immediate effects on various clinical signs and symptoms associated with central sensitization. Using a model of (innocuous, noxious and allodynia) PNE can be used in combination with exercise therapy, especially treating patients in which the nervous system has become increasingly hypervigilant. Teaching patients about the neuroscience of pain and lead to healthier and more positive attitudes and beliefs regarding chronic pain. Pain in diabetic neuropathy restrict the activity participation and compromise their quality of life. PNE will be helpful in such patients so decreasing pain can improve their quality of life.

Eligibility criteria: Inclusion Criteria:

* History of diabetic ≥ 5 years
* HbA1C higher and equal to 6.5 %
* Self-completed Leeds Assessment of Neuropathic Symptoms and Signs pain scale (S-LANSS) ≥ 12
* Mini Mental State Examination (MMSE) score ≥ 24

Exclusion Criteria:

* Known neurological disorder
* Foot ulcers/candidate of amputation
* Hearing impaired

Primary outcomes:
measure: Numeric pain rating scale (NPRS)
timeFrame: 6 weeks
measure: Self-completed Leeds Assessment of Neuropathic Symptoms and Signs pain scale (S-LANSS)
timeFrame: 6 weeks
Secondary outcomes:
measure: Diabetic peripheral neuropathic pain impact measure
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Faisalabad
country: Pakistan
facility: Allied Hospital
state: Punjab
Study officials:
affiliation: Riphah International University
name: Mirza Obaid Baig, MSPT(NMR)
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06076447: Urdu Translation and Validation of MLHFQ
Official title: Cross-Cultural Adaptation and Validation of the Urdu Version of the Minnesota Living With Heart Failure Questionnaire (MLHFQ) Among Individuals With Heart Failure
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Heart Failure
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2023-10-10
Enrollment: 210
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Heart Failure individuals

Brief summary: * To translate the Minnesota Living with Heart Failure Questionnaire (MLHFQ) questionnaire into Urdu language of Pakistan.
* To determine the validity and reliability of cross cultural adapted and Urdu translated MLHFQ questionnaire version among HF patients.


Eligibility criteria: Inclusion Criteria:

* Patients with chronic heart failure who sought treatment at the outpatient cardiology clinic.
* Who could read and write in Urdu and English language and are willing to participate in the study.

Exclusion Criteria:

* Decline consent
* Communication barriers or cognitive disorder as well as those with exacerbated condition and those who were not available for re-test were excluded from the study.

Primary outcomes:
measure: Quality of life (Minnesota Living with Heart Failure Questionnaire)
timeFrame: 6 months
Secondary outcomes:
measure: Reliability of translated versions of Minnesota Living with Heart Failure Questionnaire
timeFrame: 6 months
measure: Validity of translated versions of Minnesota Living with Heart Failure Questionnaire
timeFrame: 6 months
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Railway General Hospital
state: Punjab
Study officials:
affiliation: Riphah International University
name: Muhammad Iqbal Tariq, PhD*
role: PRINCIPAL_INVESTIGATOR
affiliation: Riphah International University
name: Arshad Nawaz Malik, PhD
role: STUDY_CHAIR
affiliation: University of Notre Dame Australia
name: Shane Patman, PhD
role: STUDY_CHAIR
References: