louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02647398: Study Comparing Two Strategies of Exercise in Breast and Colon Cancer Survivors and Their Impact on Fatigue
Official title: Randomized Study Comparing Two Strategies of Physical Activity in Long-term Breast and Colon Cancer Survivors and Their Impact on Fatigue
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neoplasms
Fatigue
Keywords: Cancer survivors
training
exercise
cancer-related fatigue
Lead sponsor: Puerta de Hierro University Hospital
Sponsor class: OTHER
Collaborators: name: Universidad Europea de Madrid
First posted: 2016-01-06
Enrollment: 32
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: SUPPORTIVE_CARE

Brief summary: Breast and colon cancer survivors with no evidence of disease, who score less than 45 in the PREDICT questionnaire for fatigue, will be randomized to a supervised strength program versus a supervised resistance program. The primary objective is improvement of cancer-related fatigue.

Detailed description: Patients should have finalized their oncological treatment in the previous 5 years. The sample size (32 patients) was calculated to improve the perception of fatigue score from an anticipated initial 38 to a post-intervention 48.

The control arm consist of supervised strength training in two sessions per week with non-supervised international recommendations for aerobic exercise. The experimental arm will consist of supervised strength + resistance training in two sessions per week.

After evaluating the weekly physical activity through accelerometer, body composition through DEXA and the cardiorespiratory fitness through CPET, participants will initiate the training according to a randomized assignment.

Secondary objectives include:

1. cardiorespiratory fitness,
2. quality of life;
3. adherence to the training program;
4. adherence to international recommendations,
5. body composition,
6. employment status

Eligibility criteria: Inclusion Criteria:

* 18-65
* history of breast or colon cancer
* no evidence of disease
* end of treatment in the last five years
* able to understand the questionnaire PERFORM
* able to manage the accelerometer

Exclusion Criteria:

* mobility limitation
* treatment with beta-blockers
* exclusion criteria for CPET

Primary outcomes:
measure: Improvement in cancer related-fatigue
timeFrame: 4 months
Secondary outcomes:
measure: Changes in cardiorespiratory fitness
timeFrame: 4 months
measure: Changes in quality of life
timeFrame: 4 months
measure: adherence to the program
timeFrame: 4 months
measure: adherence to international recommendations
timeFrame: 4 months
measure: Changes in body composition
timeFrame: 4 months
measure: Employment status
timeFrame: 4 months
Other outcomes:
Locations:
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro-Majadahonda
state: Madrid
Study officials:
affiliation: Universidad Europea de Madrid
name: Itziar Pagola, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03583398: Health-related QoL Following TAVI TAo, TAVI TF and AVR
Official title: Health-related Quality of Life Following Transcatheter Aortic Valve Implantation Using Transaortic, Transfemoral Approaches and Surgical Aortic Valve Replacement - a Single-center Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Quality of Life
Keywords: TAVI
quality of life
SAVR
Lead sponsor: Medical University of Gdansk
Sponsor class: OTHER
Collaborators: name: Institut für Pharmakologie und Präventive Medizin
First posted: 2018-07-11
Enrollment: 97
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: Elderly population with aortic valve stenosis.

Brief summary: The aim of the study was to evaluate short- and long-term changes in QoL in patients undergoing TAVI and to assess differences in patient QoL when using the TAVI TAo approach compared with the transfemoral approach (TAVI TF) and surgical aortic valve replacement (SAVR).


Eligibility criteria: Inclusion Criteria:

* aortic valve stenosis

Exclusion Criteria:

-

Primary outcomes:
measure: Health-related quality of life: EQ-5D-3L questionnaire
timeFrame: 1 month and 1 year follow-up
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01351298: Nasal Prep for Nasendoscopy in Children
Official title: Intra-nasal Topical Local Anesthetic and Decongestant for Flexible Nasendoscopy in Children: a Randomised Double-blind Placebo Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Flexible Nasendoscopy
Lead sponsor: Children's & Women's Health Centre of British Columbia
Sponsor class: OTHER
First posted: 2011-05-10
Enrollment: 69
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Flexible nasendoscopy involves passing a soft, thin, endoscope through the nose. This diagnostic procedure is often essential for assessment of a child by an Otolaryngologist in outpatients. The purpose of this randomized controlled double-blind study is to determine whether there is a difference in the degree of discomfort experienced by children undergoing flexible nasendoscopy, after receiving one of three different intranasal sprays: (A) placebo (isotonic saline solution), (B) decongestant (0.05% xylometazoline hydrochloride), or (C) decongestant with local anesthetic (0.05% xylometazoline hydrochloride with 1% lidocaine hydrochloride).

Null hypothesis: There is no difference in the degree of reported discomfort experienced (using a validated pediatric pain score) by children undergoing flexible nasendoscopy, after receiving either intra-nasal topical placebo, decongestant, or decongestant with local anesthetic.


Eligibility criteria: Inclusion Criteria:

* Fully informed consent from parent/caregiver
* Children aged 3 to 12 years
* Children deemed to require flexible nasendoscopy as part of their assessment during a Pediatric Otolaryngology clinic visit

Exclusion Criteria:

* Children who have previously undergone this procedure
* Children with current upper respiratory tract infection
* Children with known allergy to any of the trial medications

Primary outcomes:
measure: Pain score (self)
timeFrame: Immediately post-nasendoscopy - same day as administration of nasal prep agent (day 1)
Secondary outcomes:
measure: Pain score (proxy)
timeFrame: Immediately post-nasendoscopy- same day as administration of nasal prep agent (day 1)
measure: Ease of nasendoscopy score
timeFrame: Immediately post-nasendoscopy- same day as administration of nasal prep agent (day 1)
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: BC Children's Hospital
state: British Columbia
Study officials:
References:
citation: Chadha NK, Lam GO, Ludemann JP, Kozak FK. Intranasal topical local anesthetic and decongestant for flexible nasendoscopy in children: a randomized, double-blind, placebo-controlled trial. JAMA Otolaryngol Head Neck Surg. 2013 Dec;139(12):1301-5. doi: 10.1001/jamaoto.2013.5297.
Clinical trial NCT06256198: Role of PCO2 Gap as Predictor of Clinical Outcome in ICU Septic Patients
Official title: Comparison Between PCO2 Gap, Lactate and Procalcitonin as Predictors of Clinical Outcome in ICU Septic Patients
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Sepsis
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2024-02-13
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients admitted in ICU departments with sepsis

Brief summary: Sepsis is a life-threatening organ dysfunction caused by a dysregulated host response to infection, if not recognized early and managed promptly, it can lead to septic shock, multiple organ failure and death. Sepsis is associated with high mortality, and the early recognition of the signs of tissue hypo perfusion is crucial in its management.

This prospective study was aimed to detect that PCO2 gap can be taken as a reliable prognostic tool in septic patients

Detailed description: In the community setting, sepsis often presents as the clinical deterioration of common and preventable infections. Sepsis also frequently results from infections acquired in health care settings, which are one of the most frequent adverse events during care delivery and affect hundreds of millions of patients worldwide every year The venous-to-arterial carbon dioxide difference (Pv-aCO2) can indicate the adequacy of microvascular blood flow in the early phases of resuscitation in sepsis. Hence, other resuscitation goals, such as PCO2 gap, have been suggested, due to their ability to predict adverse clinical outcomes and simplicity in patients achieving normal oxygen-derived parameters during the early phases of resuscitation in septic shock.

Blood lactate level is also useful in evaluating sepsis. Serum lactate is a good indicator of the presence of hypoxic tissue during septic shock, since its production takes place during Anerobic metabolism.

Procalcitonin (PCT) is the precursor of calcitonin, and higher levels are associated with the development of sepsis. Com¬monly, there is an elevation of PCT levels 4 h after the on¬set of symptoms, peaking between 8 h and 24 h.

Eligibility criteria: Inclusion Criteria:

* Adult septic patients ≥ 21 years old

Exclusion Criteria:

* Patients with history of chronic obstructive pulmonary disease and bronchial asthma.

Primary outcomes:
measure: prediction of clinical outcome in ICU septic patients
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00837798: RATE Registry - Registry of Atrial Tachyarrhythmia/Atrial Fibrillation (AT/AF) Episodes in the Cardiac Rhythm Management (CRM) Device Population
Official title: Registry of AT/AF Episodes in the CRM Device Population: RATE Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2009-02-05
Enrollment: 5379
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a CRM device

Brief summary: The purpose of this registry is to produce a prospective, outcome-oriented registry to document the prevalence of AT/AF in the CRM population by using the Advanced AT/AF Diagnostics in select SJM devices.


Eligibility criteria: Inclusion Criteria:

* Patient is implanted with a CRM device
* Patient has no documented history of AF (3 months prior to enrollment)
* Patient is \>18 years of age
* Patient has life expectancy of \>24 months

Primary outcomes:
measure: Prevalence of atrial tachycardia and atrial fibrillation in a cardiac rhythm management population
timeFrame: 24 months
Secondary outcomes:
measure: Development or exacerbation of HF
timeFrame: 2 years
measure: Development of AF
timeFrame: 2 years
measure: AT/AF burden
timeFrame: 2 years
Other outcomes:
Locations:
city: Sylmar
country: United States
facility: St Jude Medical
state: California
Study officials:
affiliation: University Hospitals Cleveland Medical Center
name: Albert Waldo, MD
role: STUDY_CHAIR
References:
citation: Orlov MV, Olshansky B, Benditt DG, Kotler G, McIntyre T, Fujian Qu, Turkel M, Gorev M, Poghosyan H, Waldo AL. Is competitive atrial pacing a possible trigger for atrial fibrillation? Observations from the RATE registry. Heart Rhythm. 2021 Jan;18(1):3-9. doi: 10.1016/j.hrthm.2020.07.028. Epub 2020 Jul 30.
citation: Swiryn S, Orlov MV, Benditt DG, DiMarco JP, Lloyd-Jones DM, Karst E, Qu F, Slawsky MT, Turkel M, Waldo AL; RATE Registry Investigators. Clinical Implications of Brief Device-Detected Atrial Tachyarrhythmias in a Cardiac Rhythm Management Device Population: Results from the Registry of Atrial Tachycardia and Atrial Fibrillation Episodes. Circulation. 2016 Oct 18;134(16):1130-1140. doi: 10.1161/CIRCULATIONAHA.115.020252.
Clinical trial NCT05888298: Proximal and Distal Approach GON RFT in Migraine
Official title: Proximal and Distal Approach GON RFT in Migraine
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Migraine Disorders
Headache Migraine Chronic
Keywords: greater occipital nerve block
radiofrequency
Lead sponsor: Diskapi Teaching and Research Hospital
Sponsor class: OTHER
First posted: 2023-06-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Greater occipital nerve pulsed radiofrequency therapy is used in the treatment of migraine. This method is applied at the level of the proximal c2 vertebra and by approaching the nerve from the distal 1/3 medial of the occipital protuberant. The investigators aimed to compare the effectiveness of these two methods.

Detailed description: Greater occipital nerve (GON) pulsed radiofrequency application is used in migraine headaches. The procedure is applied by approaching the occipital nerve trace with a radiofrequency needle, giving a pulsed radiofrequency current for 4 minutes, and then injecting 2.5 cc bupivacaine and saline. There are two types of applications. In the proximal/central approach, the injection is administered to the occipital nerve between the semispinalis capitis muscle and the obliquus capitis inferior, under ultrasound guidance, while in the distal approach, it is administered 1/3 cm medial to the occipital protuberant with a blind technique.

The investigators aim to compare the treatment response at 1 and 3 months between two patient groups treated with both methods. For this purpose, The investigators planned to follow up with 60 patients. GON RF will be performed with a proximal approach to half of the patients and a distal approach to the other half. Pain levels will be measured on the Visual Analogue Scale (VAS) in the 1st and 3rd months after the procedure. Migraine Disability Index (MIDAS) will be applied to the patients in the 1st week and 3rd month after the procedure. Thus, it will be determined whether there is a difference between the approaches in terms of pain palliation.

Patients who have undergone the procedure will be found from their file records and called by phone, when they come to the control, face to face and 1-3. In the months, the scales will be filled by calling by phone.

Eligibility criteria: Inclusion Criteria:

* Primary migraine hedache, first interventional treatment for headache

Exclusion Criteria:

* Preganancy, malignancy

Primary outcomes:
measure: The MIDAS (Migraine Disability Assessment) questionnaire
timeFrame: Change from Baseline MIDAS at 3 months
measure: VAS Visual analog scale
timeFrame: Change from Baseline MIDAS at 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Diskapi Training and Research Hospital
city: Ankara
country: Turkey
facility: Dişkapi Reserch and Education Hospital
Study officials:
affiliation: Diskapi TRH
name: Damla Yuruk
role: STUDY_DIRECTOR
References:
Clinical trial NCT00033098: Cocaine-Metyrapone Interaction Study - 1
Official title: Cocaine-Metyrapone Interaction Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Cocaine-Related Disorders
Infusions, Intravenous
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
Collaborators: name: Cincinnati VA Medical Center
First posted: 2002-04-08
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine the safety of two consecutive days of metyrapone (MRP) in subjects who may use cocaine concurrently.

Detailed description: To evaluate the safety of metyrapone (MRP) for using in an outpatient study in which participants would be given 2 750 mg doses of MRP per week. Secondary study goals are to evaluate the possible efficacy of MRP as a treatment for cocaine dependence and to compare 3 factors hypothesized to induce cocaine craving: cocaine cues, stress, and cocaine itself. This study will utilize a Double Blind, placebo-controlled crossover design with 3 factors: 1) medication 2) relapse trigger and 3) infusion for an 11 day in-patient treatment.

Eligibility criteria: Inclusion Criteria:

Male or Females between 18 and 45 yrs of age; cocaine dependence according to DSM-4; females of child-bearing potential must test non-pregnant and use adequate birth control; be able to provide consent, comply with protocol requirements and try to complete all study treatments.

Exclusion Criteria:

Additional criteria available during screening at the site.

Primary outcomes:
measure: Cocaine craving
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati VA Medical Center
state: Ohio
Study officials:
affiliation: Cincinnati VA Medical Center
name: Theresa Winhusen, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03484598: Clinical Utility of the SPEAC® System: A Case Series
Official title: Clinical Utility of the SPEAC® System: A Case Series
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Epilepsy
Lead sponsor: Brain Sentinel
Sponsor class: OTHER
First posted: 2018-04-02
Enrollment: 26
Sex: ALL
Minimum age (years): 22
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The primary objective is to collect preliminary data related to the clinical utility of the SPEAC System in patients with a history of motor seizures. This trial is primarily an observational investigation. This protocol describes a series of observational case studies. Each case study is intended to be interpreted independent from the other case studies. Self-reported seizure frequency will be compared to observed seizure frequency using the SPEAC System.


Eligibility criteria: Inclusion Criteria:

* Subject has a reported history of motor seizures (epileptic or not or unknown) with upper extremity motor involvement.
* The subject's first reported seizure must be within the last 5 years.
* Male or Female between the ages 22 and 99.
* If female and of childbearing potential, subject must agree to not become pregnant during the trial.
* Can understand and sign written informed consent, or will have a parent or a legally authorized representative (LAR) who can do so, prior to the performance of any study assessments.
* Subject or Primary Caregiver must be competent to follow all study procedures.
* Subject must be willing to use the Seizure Monitoring and Alerting System for a long period of time (up to 90 days), for a minimum of 30 hours/ week.

Exclusion Criteria:

* The subject cannot be pregnant, or nursing.
* The subject cannot be sensitive or allergic to adhesives or tapes.

Primary outcomes:
measure: Compare Seizure Frequency
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: The University of South Florida
state: Florida
city: Austin
country: United States
facility: Austin Epilepsy Care Center
state: Texas
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
Study officials:
References:
Clinical trial NCT05134298: Pharmacokinetics of Piperacillin and Meropenem in ICU Patients
Official title: First Dose Pharmacokinetics for Piperacillin and Meropenem in ICU Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Antibiotic Pharmacokinetics
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
First posted: 2021-11-24
Enrollment: 50
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: ICU-patients.

Brief summary: The purpose of the study is to characterize the pharmacokinetics of meropenem and piperacillin in ICU-patients at the time of the first dose administration and to contrast that with the same measurements obtained in the same patient 2-3 days later during the course of ICU treatment.


Eligibility criteria: Inclusion Criteria:

- Patient being treated in one of the participating ICUs and planned to recieve treatment with meropenem or piperacillin.

Exclusion Criteria (fullfilling any exlusion criteria means that patient cannot be included in the study):

* Not possible to retrospectively ask the patient or next of kin for consent to take part in the study or patient or next-of-kin not providing consent.
* Not posisble to obtain and process blood samples as specified by protocol.
* Ongoing renal replacement therapy.
* Patient having received the same antibiotic within the previous 96 h.

Primary outcomes:
measure: Volume of distribution
timeFrame: For the first antibiotic administration and if possible for a second administration 48-72 hour later.
measure: Plasma clearance
timeFrame: For the first antibiotic administration and if possible for a second administration 48-72 hour later.
Secondary outcomes:
measure: Plasma antibiotic concentrations at mid and end of dosing interval
timeFrame: For the first antibiotic administration and if possible for a second administration 48-72 hour later.
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
Study officials:
References:
Clinical trial NCT03046498: Addressing Diabetes Together
Official title: Addressing Diabetes Together: Implementation of a Regional Partnership for Population Health Management in Southeast Minnesota
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2017-02-08
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Integration of Diabetes Prevention Program (DPP) and Diabetes Self Management Program (DSMP) into WellConnect.


Eligibility criteria: Inclusion Criteria:

* Adults 18 years or older
* Diagnosis of diabetes
* enrolled in the DSMP or DPP

Exclusion Criteria:

* unable to provide consent

Primary outcomes:
measure: Measure change in number of program offerings implemented in the community
timeFrame: Change from Baseline to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
References:
citation: Leppin AL, Okamoto JM, Organick PW, Thota AD, Barrera-Flores FJ, Wieland ML, McCoy RG, Bonacci RP, Montori VM. Applying Social Network Analysis to Evaluate Implementation of a Multisector Population Health Collaborative That Uses a Bridging Hub Organization. Front Public Health. 2018 Nov 2;6:315. doi: 10.3389/fpubh.2018.00315. eCollection 2018.