louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02287753: Relationship Between Parameters of VOT Using NIRS and Clinical Outcomes in Pediatric Cardiac Surgery
Official title: Relationship Between Parameters of Vascular Occlusion Test Using Near Infrared Spectroscopy and Clinical Parameters & Outcomes in Pediatric Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congenital Heart Disease
Keywords: vascular occlusion test
near infrared spectroscopy
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2014-11-11
Enrollment: 130
Sex: ALL
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to evaluate the ability of vascular occlusion test (VOT) during cardiac surgery to predict postoperative outcomes in pediatric patients.

Detailed description: After induction of anesthesia, pediatric SomaSensor for INVOS 5100C is attached at calf muscle and non-invasive blood pressure cuff is applied to ipsilateral thigh. VOT is performed as: after baseline oxygen saturation value is recorded, cuff pressure is rapidly increased to 30 mmHg over than systolic blood pressure. After 3 minutes of ischemic time, cuff pressure is rapidly decreased. It is performed at 3 time periods : before start of operation, during cardiopulmonary bypass, and after weaning from cardiopulmonary bypass. Postoperative outcome variables are recorded after surgery : major adverse event, use of inotropic and vasoactive drugs, duration of mechanical ventilation and ICU stay. The relationship between the results of VOT and postoperative outcome will be investigated.

Eligibility criteria: Inclusion Criteria:

* Pediatric patients aged under 8 years old who are scheduled for cardiac surgery

Exclusion Criteria:

* Skin disease
* Skin preparation involving thigh
* Peripheral vascular disease

Primary outcomes:
measure: Major adverse event
timeFrame: up to 1 years after surgery
Secondary outcomes:
measure: Use of inotropic and vasoactive drugs
timeFrame: up to 1 years after surgery
measure: Length of mechanical ventilation time and ICU stay
timeFrame: up to 1 years after surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul national university hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jin-Tae Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lee JH, Jang YE, Song IK, Kim EH, Kim HS, Kim JT. Near-Infrared Spectroscopy and Vascular Occlusion Test for Predicting Clinical Outcome in Pediatric Cardiac Patients: A Prospective Observational Study. Pediatr Crit Care Med. 2018 Jan;19(1):32-39. doi: 10.1097/PCC.0000000000001386.
Clinical trial NCT03708653: Single Nucleotide Polymorphisms (SNPs) Associated With Postherpetic Neuralgia
Official title: Association Between Some Candidate Single Nucleotide Polymorphisms and Postherpetic Neuralgia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postherpetic Neuralgia
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2018-10-17
Enrollment: 181
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Herpes zoster patients in a large university hospital

Brief summary: Postherpetic neuralgia (PHN) is a common condition and affecting 5 to 30% of the herpes zoster patients. In some cases, the pain remained refractory after first and second line treatment for herpes zoster. This suggests that there may be genetic variants that make some patients susceptible to PHN. Using saliva samples from herpes zoster patients the investigators are going to analyze the relationship between single nucleotide polymorphisms (SNPs) in genes that are known to be involved in pain and PHN.


Eligibility criteria: Inclusion Criteria:

* Age more than 50 years
* Clinically defined herpes zoster patients

Exclusion Criteria:

* Patients not able to provide informed consent

Primary outcomes:
measure: correlation between pain SNPs and PHN
timeFrame: At Enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The second affiliated hospital of Zhejiang University
state: Zhejiang
Study officials:
affiliation: Zhejiang University
name: Min Yan, Doctor
role: STUDY_DIRECTOR
References:
Clinical trial NCT02315053: PET Response During Chemoradiation of Lung Cancer
Official title: Dynamic FDG-PET/CT Response During Chemoradiation for NSCLC
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: NSCLC
Keywords: NSCLC
CCRT
FDG PET/CT
Lead sponsor: The Netherlands Cancer Institute
Sponsor class: OTHER
First posted: 2014-12-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A prospective observational study to determine the prognostic value of the timing of 50% reduction in metabolic activity (T50) during CCRT for NSCLC for treatment outcome (PFS).

Detailed description: This is a single-centre observational study. Patients with proven locally advanced NSCLC will be treated with concurrent chemoradiotherapy according to the standard clinical protocol of the NKI-AVL. During treatment, the biological behaviour of the tumour will be monitored with serial quantitative FDG (fluorodeoxyglucose) PET/CT scans. From these images, the time during treatment where a 50% reduction in FDG uptake relative to day 1 is reached (T50) will be derived. The T50 of progression-free surviving patients will be compared with that of relapsed or deceased patients, in order to find a value that predicts early treatment failure. An additional FDG PET/CT scan at the same day as regular follow up CT scan will be made, two months after treatment, to have a baseline after treatment for follow up.

Eligibility criteria: Inclusion Criteria:

* Cytologically or histologically proven NSCLC
* T2-4 N0-3 M0 disease (stage II or III, inoperable)
* Scheduled for standard concurrent chemoradiation
* Primary tumour minimal diameter 3 cm
* Primary tumour SUVmax \> 5 on routine diagnostic pre-treatment FDG (Fludeoxyglucose) PET/CT
* WHO performance 0-1
* Written informed consent according to GCP (Good Clinical Practice) and national regulations

Exclusion Criteria:

* Age \< 18 years, incapacitated subjects
* Pregnant or lactating women
* Diabetes mellitus requiring medication
* Participation in dose escalation studies
* Other neoplasms in the last 3 years, with metastases

Primary outcomes:
measure: maximum FDG uptake (SUVmax)
timeFrame: 1 Year
Secondary outcomes:
measure: SUVmax during the first two weeks of treatment, indicating inflammatory response.
timeFrame: First Two weeks of treatment
measure: SUVmax in the two weeks prior to treatment, indicating progression
timeFrame: Two weeks prior to treatment
measure: Progression free survival
timeFrame: 1 Year
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: The Netherlands Cancer Institute
state: Noord Holland
Study officials:
affiliation: NKI
name: Wouter Vogel, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05914753: Evaluating Xihuang Pill to Improve the Efficacy of Neoadjuvant Chemotherapy for Breast Cancer
Official title: A Prospective Clinical Study Evaluating Xihuang Pill to Improve the Efficacy of Neoadjuvant Chemotherapy for Breast Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Chemotherapy Effect
Lead sponsor: Zhejiang Provincial People's Hospital
Sponsor class: OTHER
First posted: 2023-06-22
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluate the effectiveness of Xihuang Pill in improving the efficacy of neoadjuvant chemotherapy for breast cancer

Detailed description: 1. To evaluate the safety and effectiveness of Xihuang Pill in improving the efficacy of neoadjuvant chemotherapy for breast cancer under the condition of widespread use.
2. To provide data support for improving the efficacy of neoadjuvant chemotherapy for clinical breast cancer patients.

Eligibility criteria: Inclusion Criteria:

1. Biopsy of breast mass was performed under ultrasound-guided treatment before neoadjuvant chemotherapy, and the diagnosis of breast cancer was confirmed pathologically, followed by immunohistochemical examination. Pathological sections before and after neoadjuvant chemotherapy were jointly diagnosed by 3 or more senior pathologists, and there were consistent definite conclusions.
2. Have detailed and complete clinicopathological data;
3. Diagnosis data of TCM syndrome type;
4. No biopsy-confirmed lymph node metastasis;
5. No serious systemic disease, able to tolerate neoadjuvant chemotherapy and surgical treatment;
6. At least 4 cycles of neoadjuvant chemotherapy were completed, and the efficacy of chemotherapy was evaluated at the end of chemotherapy and after surgery;
7. Under the guidance of doctors, take Xihuang pills in a standardized way throughout the whole process and review regularly;
8. The patient did not receive any antitumor therapy drugs associated with the tumor prior to neoadjuvant chemotherapy;
9. All patients were newly diagnosed

Exclusion Criteria:

1. Concurrent malignant tumors of other sites;
2. Patients with distant metastasis
3. Male breast cancer
4. Patients who did not receive full-course standardized neoadjuvant chemotherapy;
5. Lost contact or dropped out of the study, unable to follow up;
6. Inability to tolerate chemotherapy responses;
7. Intolerant to Xihuang Wan and unable to take it;
8. The patient has strong side effects of chemotherapy and cannot tolerate chemotherapy drugs;
9. Inflammatory breast cancer, bilateral breast cancer, paget's disease and other special types of breast cancer;
10. Various other possible influences.

Primary outcomes:
measure: Pathological complete response (pCR)
timeFrame: six months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Zhejiang Provincial People's Hospital
name: Xuli Meng
role: STUDY_CHAIR
References:
Clinical trial NCT02654353: A New Approach to Target the Substrates of Persistent Atrial Fibrillation: The Sequential Substrate Ablation Approach
Official title: A New Approach to Target the Substrates of Persistent Atrial Fibrillation: The Sequential Substrate Ablation Approach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Persistent Atrial Fibrillation
Keywords: Persistent atrial fibrillation, catheter ablation, outcome
Lead sponsor: Johannes Gutenberg University Mainz
Sponsor class: OTHER
First posted: 2016-01-13
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a prospective randomized controlled trial that compares the conventional stepwise approach with a new sequential substrate ablation approach for persistent atrial fibrillation.

Detailed description: A total number of 100 patients with persistent AF were randomized to receive either conventional stepwise ablation (conventional group) or a sequential substrate ablation (substrate group), both with the endpoint of AF termination. All patients were in AF before the procedure. The sequential substrate ablation consisted of pulmonary vein isolation (PVI) followed by cardioversion and linear ablation at the mitral isthmus, left atrial roof and cavotricuspid isthmus in order to modify the AF substrate. After achievement of bidirectional block, AF was re-induced and electrogram-based ablation was performed to achieve AF termination to sinus rhythm (SR). Endpoints are single-procedure outcome and total amount of RF ablation time required to terminate AF by electrogram-guided ablation.

Eligibility criteria: Inclusion Criteria:

* persistent atrial fibrillation lasting longer than 3 months
* no previous ablations
* at least 1 electrical cardioversion

Exclusion Criteria:

* non-persistent atrial fibrillation
* previous ablation procedures

Primary outcomes:
measure: Number of patients without any arrhythmias during follow-up of 12 months
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: University Hospital Mainz, Department of Medicine II
Study officials:
affiliation: University Hospital Mainz, Department of Cardiology
name: Thomas Rostock, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00710853: Effects of Qigong, Tai Chi and Yoga Practice in Older Adults
Official title: Effects of Qigong, Tai Chi and Yog Practice on Indicators of Health and Quality of Life in Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Geriatric
Qi gong
Yoga
Tai chi
Geriatric Assessment
Lead sponsor: Bastyr University
Sponsor class: OTHER
Collaborators: name: Gencare Incorporated
First posted: 2008-07-04
Enrollment: 50
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to compare the effects of an 8-week intervention using YiRen Qigong, Tai Chi or Hatha yoga in older adults (age 70 and above) residing at a Gencare senior living facility. Outcome measures completed at the beginning and end of each intervention period will be blood pressure, heart rate, perceived quality of life (PQOL)and a symptoms questionnaire (SF-36), ability and speed of walking 20 feet (for ambulatory participants), and neck and arm range of motion.


Eligibility criteria: Inclusion Criteria:

* Be a resident of a Gencare Senior Living facility in Granite Falls, Lynnwood, Renton, Ballard and Lake City, WA
* Be at least 70 years of age
* Be willing to participate in the tai chi, qi gong and/or yoga classes
* Willing to complete study-related outcomes assessments

Exclusion Criteria:

* Not medically able to participate in the mild level of activity involved in the 3 interventions as determined by the resident's physician
* Unable to complete study questionnaires or study procedures at screening

Primary outcomes:
measure: Blood pressure
timeFrame: End of 8-week class
measure: Heart rate
timeFrame: End of 8-week class
measure: Quality of life (SF-36 and PQOL)
timeFrame: End of 8-week class
Secondary outcomes:
measure: Adverse events
timeFrame: End of 8-week class
Other outcomes:
Locations:
city: Granite Falls
country: United States
facility: Gencare-The Village at Granite Falls
state: Washington
city: Lynnwood
country: United States
facility: Gencare-Scriber Gardens
state: Washington
city: Renton
country: United States
facility: Gencare-The Lodge at Eagle Ridge
state: Washington
Study officials:
affiliation: Bastyr University
name: Mark Martzen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01860053: A Behavioral Intervention to Decrease Vomiting and Improve Weight Loss in Post-Operative Laparoscopic Adjustable Gastric Banding (LAGB) Patients
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE2
PHASE3
Conditions: Bariatric Surgery Complications
Lead sponsor: The Miriam Hospital
Sponsor class: OTHER
First posted: 2013-05-22
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to reduce problematic vomiting and associated gastrointestinal symptoms in post-operative LAGB patients. We hypothesize that our behavioral intervention will yield greater reductions in vomiting and associated symptoms compared to our control condition.


Eligibility criteria: Inclusion Criteria:

1. Age between 18 and 70 years.
2. Received LAGB surgery with either a standard Lap-Band or a standard Realize Band.
3. Report vomiting at least 3x/week.
4. Agree to allow researchers to communicate with their surgeon regarding their care.
5. Fulfilled all hospital surgery criteria.

Exclusion Criteria:

1. Report a condition that in the judgment of the Principal Investigator would render them potentially unlikely to follow the protocol (e.g., major illness, plans to move out of the area, substance abuse or other significant psychiatric problems, organic brain disease).
2. Report planning to become pregnant during the time frame of the investigation.
3. Report a history of upper gastrointestinal dismotility.

Primary outcomes:
measure: change in frequency of self-reported vomiting (number of vomiting episodes each week) measured via structured interview
timeFrame: baseline to week 6
Secondary outcomes:
measure: change in gastrointestinal symptom severity - questionnaire measures severity of various GI symptoms over the previous week and items are summed yielding an overall GI severity index
timeFrame: baseline to week 6
Other outcomes:
Locations:
city: Providence
country: United States
facility: Weight Control and Diabetes Research Center
state: Rhode Island
Study officials:
References:
Clinical trial NCT06623253: Survey Stroke Units in Argentina
Official title: Survey on Predictors of Discharge from Stroke Units in Argentina
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surveys and Questionnaires
Evaluation of Processes and Results
Healthcare
Evidence-based Clinical Practice
Health Care System
Stroke
Patient Discharge
Lead sponsor: Hospital de Rehabilitacion Manuel Rocca
Sponsor class: OTHER
First posted: 2024-10-02
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Neurology/Clinical physician/Neurosurgery/Physiatrist/Other

Brief summary: Introduction Patients who receive care from stroke units are more likely to survive their stroke, become independent, and return home. Decision-making to decide the location of discharge is influenced more by non-clinical factors than clinical ones.

Objective To analyze the factors that are considered for discharge and how stroke patients are measured in stroke units in Argentina by the physicians who make the decisions.

Materials and methods An observational, analytical, cross-sectional survey-type study will be carried out. The recommendations given by the Checklist for Reporting of Survey Studies will be used. It will be intended for all those physicians in Argentina who work in stroke units and discharge.


Eligibility criteria: Inclusion Criteria:

* All physicians who in stroke units of Argentina and are in charge of the referral process for hospitalized patients will be included.

Exclusion Criteria:

* All surveys with missing data will be excluded

Primary outcomes:
measure: Referral location
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Caba
country: Argentina
facility: Clínica la sagrada familia
state: Buenos Aires
Study officials:
References:
Clinical trial NCT02685553: Near Infrared Technology and Laparoscopic Resection of Pancreatic Lesions: the COLPAN Project
Official title: Use of Near Infrared Technology as a Guide in Laparoscopic Resection of Pancreatic Lesions: the COLPAN "Colour-and-resect" Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pancreatic Neuroendocrine Tumors
Clear Cell Renal Carcinoma
Solid Pseudopapillary Tumors of the Pancreas
Lead sponsor: Universita di Verona
Sponsor class: OTHER
First posted: 2016-02-18
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to determine whether the use of Near-Infrared Technology can guide the laparoscopic resection of hypervascular neoplasms of the pancreas.


Eligibility criteria: Inclusion Criteria:

* age between 18 and 80
* diagnosis of hypervascular pancreatic neoplasms to be treated with laparoscopic surgery

Exclusion Criteria:

* allergy to indocyanine green or other vital stains, indium, shellfish
* chronic kidney insufficiency
* chronic hepatopathy
* hyperthyroidism, thyroid adenomas

Primary outcomes:
measure: Number of hypervascular pancreatic neoplasms detected intraoperatively by NIR
timeFrame: within the time of surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Verona
country: Italy
facility: University of Verona Hospital
Study officials:
References:
citation: Frangioni JV. In vivo near-infrared fluorescence imaging. Curr Opin Chem Biol. 2003 Oct;7(5):626-34. doi: 10.1016/j.cbpa.2003.08.007.
citation: Verbeek FP, van der Vorst JR, Schaafsma BE, Hutteman M, Bonsing BA, van Leeuwen FW, Frangioni JV, van de Velde CJ, Swijnenburg RJ, Vahrmeijer AL. Image-guided hepatopancreatobiliary surgery using near-infrared fluorescent light. J Hepatobiliary Pancreat Sci. 2012 Nov;19(6):626-37. doi: 10.1007/s00534-012-0534-6.
citation: van der Vorst JR, Vahrmeijer AL, Hutteman M, Bosse T, Smit VT, van de Velde CJ, Frangioni JV, Bonsing BA. Near-infrared fluorescence imaging of a solitary fibrous tumor of the pancreas using methylene blue. World J Gastrointest Surg. 2012 Jul 27;4(7):180-4. doi: 10.4240/wjgs.v4.i7.180.
citation: Winer JH, Choi HS, Gibbs-Strauss SL, Ashitate Y, Colson YL, Frangioni JV. Intraoperative localization of insulinoma and normal pancreas using invisible near-infrared fluorescent light. Ann Surg Oncol. 2010 Apr;17(4):1094-100. doi: 10.1245/s10434-009-0868-8. Epub 2009 Dec 22.