louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06564051: Study to Assess Monoclonal B-Cell Lymphocytosis in Individuals With Chronic Hepatitis C
Official title: A Prospective Observational Study to Assess Monoclonal B-Cell Lymphocytosis in Individuals With Chronic Hepatitis C
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Chronic Viral Hepatitis C
Monoclonal B-Cell Lymphocytosis
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2024-08-21
Enrollment: 200
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: Patients with hepatitis C who are to begin therapy with DAA seen in the Division of Gastroenterology and Hepatology at Mayo Clinic in Rochester.

Brief summary: This study evaluates the incidence of monoclonal B-cell lymphocytosis MBL) in patients with chronic hepatitis C and to determine if monoclonal b-cell lymphocytosis is affected by treatment for hepatitis C.

Detailed description: PRIMARY OBJECTIVES:

I. To determine the prevalence of MBL in patients with chronic hepatitis C who are to begin therapy with directly acting antiviral (DAA), and compare with clinic controls who are seen in the general medicine clinic at Mayo Clinic.

II. To determine the correlation between the specific subtype of MBL (CD5- MBL, atypical CLL-phenotype MBL and CLL-phenotype MBL) relative to the hepatitis C virus (HCV) genotype.

III. To assess the proportion of individuals with MBL who have an improvement in the circulating monoclonal B-cell population following therapy with DAA.

OUTLINE: This is an observational study.

Patients undergo blood sample collection and have medical records reviewed throughout study.

Eligibility criteria: Inclusion Criteria:

* Individuals with chronic hepatitis C who are to begin therapy with DAA

  * Willing to submit a peripheral blood sample at baseline, end of therapy, 12 weeks after the end of therapy, and 52 weeks from baseline

Exclusion Criteria:

* Individuals with chronic hepatitis C who have cirrhosis

  * Individuals with chronic hepatitis C who have a past history of a lymphoproliferative disorder AND for which they received chemotherapy

Primary outcomes:
measure: Prevalence of monoclonal B-cell lymphocytosis (MBL)
timeFrame: Baseline; up to one year
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic in Rochester
name: Sameer A. Parikh, M.B.B.S.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02066051: IPL and Meibomian Gland Expression to Treat Ocular Rosacea Ocular GVHD
Official title: Intense Pulsed Light (IPL) and Meibomian Gland Expression to Treat Ocular Rosacea Secondary to Inactive Chronic Ocular Graft Versus Host Disease (GVHD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: GVHD
Ocular Rosacea
Dry Eye Syndrome
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2014-02-19
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
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 was to see if Intense Pulsed Light (IPL) can be used safely and effectively to help treat dry eyes from ocular rosacea after chronic graft-versus-host disease (GVHD). Current treatment options for this disease are limited.

Detailed description: Ocular rosacea and meibomian gland disease are major contributors to keratoconjunctivitis sicca after chronic GVHD. Rosacea exacerbates the aqueous deficiency caused by damage to lacrimal and accessory lacrimal glands similar to cholestasis damage in the biliary system.

Subjects who had inactive chronic GVHD after allogeneic bone marrow transplantation and severe dry eye symptoms related to ocular rosacea were recruited and treated with 4 monthly sessions of IPL and meibomian gland expression. Their charts were reviewed prior to treatment to confirm quiescence of active systemic disease. Symptom scores were quantified with Ocular Surface Disease Index (OSDI) and Standard Patient Evaluation of Eye Dryness questionnaire (SPEED2). Baseline complete eye exam was performed, and subjects received an eyes assessment score based on the Chronic Graft-Versus-Host Disease (GVHD) Assessment and Scoring Form.

Symptoms, exam, and diagnostic data were obtained at baseline (month 0, month 1, month 2, month 3, month 4, month 5, month 6, month 9 and month 12). IPL treatment and meibomian gland expression was performed at baseline (month 0), month 1, month 2, and month 3.

Eligibility criteria: Inclusion Criteria:

* Ocular rosacea with inactive GVHD

Exclusion Criteria:

* Active GVHD
* Facial laser treatment
* Accutane exposure
* Inability to wear sun protection factor (SPF) 30 sunscreen and avoid sun exposure
* Inability to meet study requirements

Primary outcomes:
measure: Number of Participants Who Responded to Intense Pulsed Light (IPL)
timeFrame: 12 months
Secondary outcomes:
measure: Number of Participants Who Experienced Adverse Events
timeFrame: 12 months
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic Arizona
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Joanne Shen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01291251: Compliance With Antibiotic Treatment in General Practice
Official title: Compliance With Antibiotic Treatment in General Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patient Compliance
Lead sponsor: Norwegian Medical Association
Sponsor class: OTHER
First posted: 2011-02-08
Enrollment: 270
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients in two different primary care clinics.

Brief summary: The guidelines of The Norwegian authorities concerning the use of antibiotics in general practice state that for several common diseases such as pneumonia and tonsillitis, antibiotics should be given four times daily instead of three times daily. The study´s aim is to see whether the patient compliance is significantly reduced in antibiotic regimes of 3 or 4 daily doses as compared to 1 or 2 daily doses.

Detailed description: All patients given antibiotic tablets, independent of diagnosis and medicament, are included. All patients give a written consent. Within a week after the end of the treatment all patients are contacted by one of the authors and asked a few standardized questions concerning their compliance with the treatment.

Eligibility criteria: Inclusion Criteria:

* Any patient given antibiotics for any cause

Exclusion Criteria:

* Use of mixture instead of tablets
* Tablets administrated by public health care services

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Arendal
country: Norway
facility: Hisøy legekontor
state: Aust-Agder
city: Froland
country: Norway
facility: Froland legekontor
state: Aust-Agder
Study officials:
affiliation: University of Oslo
name: Mette Brekke, Ph D
role: STUDY_DIRECTOR
References:
Clinical trial NCT06600451: A Retrospective Data Collection on NobelProcera® Zirconia Implant Bridges from 4 to 14 Units.
Official title: A Retrospective Multicenter Clinical Data Collection to Evaluate the Safety, Performance, and Clinical Benefits of NobelProcera® Zirconia Implant Bridges from 4 to 14 Units in Daily Dental Practice
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Dental Prosthesis, Implant-Supported
Keywords: dental prosthesis
NobelProcera
implant supported prosthesis
zirconia bridge
Lead sponsor: Nobel Biocare
Sponsor class: INDUSTRY
First posted: 2024-09-19
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated with at least one NobelProcera Zirconia Implant Bridge from 4- to 14-unit.

Brief summary: This is a retrospective multicenter data collection in which clinical and radiographic data on implant zirconia bridges are collected from partially or fully edentulous subjects consecutively treated with at least one 4- to 14-unit NobelProcera® Zirconia Implant Bridge. This data collection will be conducted in up to 11 centers (see Appendix I) and will include between 150 to 200 subjects.

The aim of this retrospective multicenter data collection is to evaluate the safety, performance, and clinical benefits of NobelProcera® Zirconia Implant Bridges (4 to 14 units) in daily dental practice.


Eligibility criteria: Inclusion Criteria:

* Subject was at least 18 years old at the time of treatment,
* Subjects treated with at least one NobelProcera® Zirconia Implant Bridge (4- to 14-unit supported by 2 to 10 implants).

Exclusion Criteria:

* none

Primary outcomes:
measure: complications
timeFrame: from bridge placement to last follow-up (up to 36 months follow-up)
Secondary outcomes:
Other outcomes:
Locations:
city: Kloten
country: Switzerland
facility: Nobel Biocare Sevices AG
Study officials:
References:
Clinical trial NCT01933451: Outcome Study of Restrictive vs. Liberal Intraoperative Fluid Management Guided by PPV in Esophagectomy
Official title: Postoperative Lung Function, Kidney Function, Inflammatory Response and Short-term Outcome After Esophagectomy and Reconstruction: Intraoperative Fluid Management Controlled With Lower and Higher Pulse Pressure Variation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Other Complications of Esophagostomy
Keywords: fluid therapy
Intraoperative care
Patient Outcome Assessment
pulse pressure variation
restrictive fluid therapy
goal-directed fluid therapy
esophagectomy
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2013-09-02
Enrollment: 7
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine whether intraoperative restrictive fluid management guided by pulse pressure variation produces a better effect on the postoperative lung function, kidney function, inflammatory response and short-term outcome after esophagectomy and reconstruction.

Detailed description: Measurements: intraoperative Lung injury score, Lung water index, Pulmonary vascular Permeability Index Measurements: intraoperative and postoperative Plasma creatine, C reactive protein (CRP), lactate, Neutrophil gelatinase-associated lipocalin (NGAL), Interleukin-6 (IL-6), Interleukin-8 (IL-8)

Eligibility criteria: Inclusion Criteria:

* patients undergoing esophagectomy and reconstruction

Exclusion Criteria:

* ASA score \>= 3, (American Society of Anesthesiologist physical status classification system)
* arrythmia, atrial fibrillation
* lung diseases, such as COPD (chronic obstructive pulmonary disease); lung function test showed moderate to severe ventilation defect
* plasma creatinine level above 1.5 mg/dl

Primary outcomes:
measure: postoperative lung function, kidney function, inflammatory response
timeFrame: from introperative to postoperative day 2
Secondary outcomes:
measure: postoperative short-term outcome
timeFrame: the duration of hospital stay, about 4 weeks
Other outcomes:
Locations:
city: Taipei City
country: Taiwan
facility: Department of Anesthesiology, National Taiwan University Hospital
Study officials:
affiliation: chengyj@ntu.edu.tw
name: Ya-Uyng Cheng, MD. PHD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01408251: Agreement Between Arterial, Central Venous, and Peripheral Venous Lactate Measurements in the Intensive Care Unit
Official title: Agreement Between Arterial, Central Venous, and Peripheral Venous Lactate in the Intensive Care Unit
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acid-base Analysis
Lead sponsor: Olive View-UCLA Education & Research Institute
Sponsor class: OTHER
First posted: 2011-08-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Intensive Care Unit patients requiring both an arterial line and central venous line as part of their clinical care

Brief summary: The purpose of this study is to see if blood obtained from a vein (smaller blood vessel) can be used instead of blood obtained from an artery (larger blood vessel).


Eligibility criteria: Inclusion Criteria:

* Patients admitted to the ICU and requiring both an arterial line and central venous line as prt of their clinical care

Exclusion Criteria:

* Patient did not desire to participate

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: VA Greater Los Angeles Healthcare System
name: Richard M Treger, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05650151: Peri-operative Vitamin D Therapy for Hepatectomy
Official title: Peri-operative Vitamin D Therapy for Patients With Hepatocellular Carcinoma Receiving Hepatectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Vitamin D Deficiency
Hepatocellular Carcinoma
Perioperative Complication
Keywords: Vitamin d therapy
Hepatocellular Carcinoma
Perioperative Complication
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: Taipei Veterans General Hospital, Taiwan
First posted: 2022-12-14
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this double-blind, randomized controlled trial is to test the effect of short-term and high-dose vitamin D therapy in patients undergoing hepatectomy for hepatocellular carcinoma.

Detailed description: Participants will receive short-term high dose of vitamin D during perioperative period.

The main questions the study aims to answer are:

1. If vitamin D therapy benefits perioperative care
2. If short-term high dose of vitamin D supplement is safe

Eligibility criteria: Inclusion Criteria:

* Patients older than 20 years
* Patients will undergo hepatectomy for hepatocellular carcinoma.

Exclusion Criteria:

* Patients with hypercalcemia, hyperparathyroidism, sarcoidosis, multiple myeloma

Primary outcomes:
measure: Infection rate
timeFrame: Perioperative period
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: National Taiwan University Hospital
name: Yin-Yi Han, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06010251: Utility of Multisensory Body-Representation in Spinal Cord Injury (SCI) With Pain
Official title: Mechanisms and Utility of Multisensory Body- Representation in SCI and SCI-Related Neuropathic Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spinal Cord Injuries
Neuropathic Pain
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2023-08-24
Enrollment: 30
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 effectiveness of bodily illusions combined with transcranial direct current stimulation (tDCS) on neuropathic pain symptoms and sensory functions in participants with spinal cord injury (SCI) and neuropathic pain.


Eligibility criteria: The study will be open to people of any ethnicity, racial background, and gender.

Inclusion criteria:

SCI with Pain:

1. Men or women
2. fluent in English
3. 18-70 years of age who have: (3a) Complete and incomplete SCI, level of injury (above L1); (3b) Persistent neuropathic pain started after the injury for a minimum of three months prior to entering the study that is at least moderate in severity, defined as ≥ 4 on a Numeric Rating Scale (NRS) ranging 0 to 10.

Exclusion criteria:

Participants will be excluded if they have:

1. Major psychiatric disease/disorder (self-reported);
2. a significant neurological trauma (self-reported) other than SCI;
3. a recent (one-year) history of alcohol or drug abuse assessed by the Drug Abuse Screening Test (DAST-10)
4. history of visual and hearing loss not corrected
5. history of epilepsy or seizures
6. any metal implants in the head, or implanted devices such as cochlea implants or cardiac pacemakers.

We will not include any special population like:

Adults unable to consent Individuals who are not yet adults (infants, children, teenagers) Pregnant women Prisoners

Primary outcomes:
measure: Change in neuropathic pain severity assessed by Neuropathic Pain Symptom Inventory (NPSI)
timeFrame: Baseline, up to 4 weeks
measure: Change in neuropathic pain interference assessed by pain interference questionnaire.
timeFrame: Baseline, up to 4 weeks
measure: Changes associated with sensory function/dysfunction assessed by quantitative sensory testing
timeFrame: Baseline, up to 4 weeks
Secondary outcomes:
measure: Change in manageable pain assessed by days of manageable pain questionnaire.
timeFrame: Baseline, up to 4 weeks
measure: Changes of psychosocial assessed by Multidimensional Pain Inventory (pain severity subscale)
timeFrame: Baseline, up to 4 weeks
measure: Change in Global impression of changes by PGIC questionnaire
timeFrame: Baseline, up to 4 weeks
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Eva Widerstrom-Noga, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02911051: Clinical Study Evaluating the Safety of a New Catheter for Urinary Intermittent Catheterization in Self Catheterized Patients
Official title: Clinical Study Evaluating the Safety of a New Catheter for Urinary Intermittent Catheterization in Self Catheterized Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intermittent Urethral Catheterization
Lead sponsor: BBraun Medical SAS
Sponsor class: INDUSTRY
First posted: 2016-09-22
Enrollment: 22
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The clinical study evaluates the safety of a new catheter for Urinary Intermittent Catheterisation in self catheterized patients


Eligibility criteria: Inclusion Criteria:

1. male patient
2. patient is at least 18 years old
3. patient having normal or impaired sensation in the urethra
4. patient catheterizing at least 4 times a day
5. patient using Ch 12 or 14 catheter for self clean urinary catheterization
6. patient using a Nelaton catheter for self clean urinary catheterization
7. patient using self clean urinary catheterization for at least one month
8. patient covered with social insurance

Exclusion Criteria:

1. patient having a symptomatic urinary tract infection as assessed by the investigator (5 days after end of treatment for UTI, patient can be considered by the investigator for inclusion)
2. patient with urethral hypersensitivity
3. patient being mentally unstable not being assessed by the investigator as capable to follow the study procedure
4. patient already participating in another clinical study or who have previously participated in this investigation

Primary outcomes:
measure: Safety of Hydrolite Cath will be demonstrated by listing any adverse event(s) related to the use of Actreen® Hydrolite Cath and other occurrence
timeFrame: All adverse event(s) occured during the 7 (±1) days, related to the use of Actreen Hydrolite Cath, will be registered.
Secondary outcomes:
Other outcomes:
Locations:
city: Garches
country: France
facility: Chartier-Kastler
Study officials:
affiliation: Hôspital Raymond Poincaré - Garches
name: Chartier-Kastler Emmanuel
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04846751: Exercise Type That Faster Reduces Postprandial Glycemia.
Official title: Exercise Type That Faster Reduces Postprandial Glycemia.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Glucose, High Blood
Exercise-Induced Hyperinsulinism
Lead sponsor: University of Castilla-La Mancha
Sponsor class: OTHER
First posted: 2021-04-15
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Study composed of 4 trials, full-crossover, administered in a randomized order with the inclusion of a control trial.
Primary purpose: PREVENTION

Brief summary: It is well established that a bout of 50 min of continuous moderate intensity exercise, improves insulin sensitivity up to 48 hours after the bout. However, it is less well known, what is the exercise type more efficient to buffer the elevations in blood glucose elicited by carbohydrate ingestion. The purpose of this study is to elucidate if intervalic exercise is superior to continous on improving postprandial glycemic control.

Detailed description: Carbohydrate oxidation, glucose and insulin blood concentrations, isotopically measured rate of appearance of endogenous and exogenous glucose will be measured in 4 ocassions.

Participants will undergo in a cross-over randomized fashion the following trials:

1. Exercise pedalling during 50 min at 60% of their VO2max followed by an oral glucose tolerance test (OGTT).
2. Exercise pedalling during 50 min in a hot environment (33ºC) at 60% of their VO2max followed by an oral glucose tolerance test (OGTT).
3. Exercise pedalling during 50 min using intervalic bouts averaging 60% of VO2max followed by an oral glucose tolerance test (OGTT).
4. No exercise, followed by an oral glucose tolerance test (OGTT).

Eligibility criteria: Inclusion Criteria:

* Participant must be capable and willing to provide consent, understand, instructions and protocols.
* Minimal fitness level to be able to complete 50 min of continous exercise at a moderate intensity.

Exclusion Criteria:

* Smokers
* Pregnancy
* Any non-controlled medical condition which could influence results or could be worsened by exercise

Primary outcomes:
measure: Blood glucose concentration
timeFrame: 16 weeks
measure: Blood insulin concentration
timeFrame: 16 weeks
Secondary outcomes:
measure: Carbohydrate oxidation
timeFrame: 16 weeks
measure: Turnover rate of endogenous and exogenous glucose
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Toledo
country: Spain
facility: University of Castilla-La Mancha (Exercise Physiology Lab)
Study officials:
affiliation: University of Castilla-La Mancha
name: Ricardo Mora-Rodriguez, PhD
role: PRINCIPAL_INVESTIGATOR
References: