louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00363324: Bone Marrow Cells in Myocardial Infarction
Official title: Effects of Autologous Bone Marrow Celss on Acute ST-Elevation Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Acute Myocardial Infarction
Keywords: stem cell
acute myocardial infarction
Lead sponsor: University of Oulu
Sponsor class: OTHER
First posted: 2006-08-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is aimed to assess the effect of bone marrow cells on arrhythmia risk variables in patients with a acute myocardial infarction.

Detailed description: This is a randomized, double-blinded study, where patients treated with thrombolytic therapy for acute myocardial infarction are randomized to receive bone-marrow derived stem cells or sham-infusion at the time percutaneous coronary intervention of the target vessel. The end-points are many arrhythmia risk variables, suchs as heart rate variability, T-wave alternans and many ECG variables as well as systolic and diastolic left ventricular function.

Eligibility criteria: Inclusion Criteria:

* Acute ST-elevation myocardial infarction treated with thrombolytic therapy

Exclusion Criteria:

* Indication for rescue PCI, severe clinical heart failure, age \<18 years

Primary outcomes:
measure: Arrhythmia risk variables
measure: left ventricular function
measure: restenosis assessed by IVUS
Secondary outcomes:
measure: exercise tolerance
Other outcomes:
Locations:
city: Oulu
country: Finland
facility: University of Oulu
Study officials:
affiliation: University of Oulu
name: Heikki V Huikuri, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Miettinen JA, Salonen RJ, Niemela M, Kervinen K, Saily M, Koistinen P, Savolainen ER, Ukkonen H, Pietila M, Airaksinen KE, Knuuti J, Makikallio TH, Huikuri HV, Ylitalo KV. Effects of intracoronary infusion of bone marrow-derived stem cells on pulmonary artery pressure and diastolic function after myocardial infarction. Int J Cardiol. 2010 Dec 3;145(3):631-3. doi: 10.1016/j.ijcard.2010.09.064. Epub 2010 Oct 20. No abstract available.
citation: Miettinen JA, Ylitalo K, Hedberg P, Jokelainen J, Kervinen K, Niemela M, Saily M, Koistinen P, Savolainen ER, Ukkonen H, Pietila M, Airaksinen KE, Knuuti J, Vuolteenaho O, Makikallio TH, Huikuri HV. Determinants of functional recovery after myocardial infarction of patients treated with bone marrow-derived stem cells after thrombolytic therapy. Heart. 2010 Mar;96(5):362-7. doi: 10.1136/hrt.2009.171694. Epub 2009 Nov 11.
citation: Huikuri HV, Kervinen K, Niemela M, Ylitalo K, Saily M, Koistinen P, Savolainen ER, Ukkonen H, Pietila M, Airaksinen JK, Knuuti J, Makikallio TH; FINCELL Investigators. Effects of intracoronary injection of mononuclear bone marrow cells on left ventricular function, arrhythmia risk profile, and restenosis after thrombolytic therapy of acute myocardial infarction. Eur Heart J. 2008 Nov;29(22):2723-32. doi: 10.1093/eurheartj/ehn436. Epub 2008 Oct 9.
Clinical trial NCT03996824: Study of Viral Transduction of Human Auditory Sensory Cells for the Development of Gene Therapy
Official title: Study of Viral Transduction of Human Auditory Sensory Cells for the Development of Gene Therapy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hearing Loss, Sensorineural
Lead sponsor: Institut Pasteur
Sponsor class: INDUSTRY
Collaborators: name: Assistance Publique - Hôpitaux de Paris
First posted: 2019-06-25
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing surgical resection of vestibular schwannoma.

Brief summary: Gene therapy is a promising strategy to treat hearing loss and vestibular disorders, and Associated adenovirus (AAV) is shown as a good viral vector for inner ear therapy in animal models.

This study aims to study in vitro viral transduction of AAV in human inner ear cells, collected during non-conservative surgeries for vestibular schwannoma.


Eligibility criteria: Inclusion Criteria:

* Patient ≥ 18 years old
* Operative indication for a non-conservative resection of vestibular schwannoma, decided by the surgeon in accordance with the patient
* Informed consent obtained
* Patients with a french social protection (AME excluded)

Exclusion Criteria:

* Intravestibular or intra-cochlear extension of the tumor
* Pregnant woman
* Patient with administrative control
* Medical contra-indication

Primary outcomes:
measure: AAV transduction in inner ear cells
timeFrame: 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Le Kremlin-Bicêtre
country: France
facility: Hôpital de Bicêtre
state: Ile De France
city: Paris
country: France
facility: Hôpital Pitié-Salpétrière
state: Ile De France
Study officials:
affiliation: Institut Pasteur
name: Ghizlene Lahlou
role: STUDY_DIRECTOR
References:
Clinical trial NCT02477124: A See and Treat Paradigm for Cervical Pre-cancer
Official title: A See and Treat Paradigm for Cervical Pre-cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cervical Pre-cancer
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2015-06-22
Enrollment: 514
Sex: FEMALE
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to see if the transvaginal colposcope produces similar results to colposcopy for the screening of cervical cancer. In this study the investigators are using an investigational device called the transvaginal colposcope. The word investigational means that the device is still being tested in research studies and is not approved by the U.S. Food and Drug Administration (FDA).


Eligibility criteria: Inclusion Criteria:

* Patients undergoing cervicography OR colposcopy OR VIA OR patients undergoing LEEP for the treatment of cervical cancer.
* Age 25 and greater
* Patients of all ethnic backgrounds will be included.
* Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Children and subjects under 25.

Primary outcomes:
measure: Number of Participants for Which the Standard of Care Diagnosis and the Diagnosis of the TVDC Image Agree
timeFrame: Up to approximately 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: New Delhi
country: India
facility: AIIMS
city: Lima
country: Peru
facility: La Liga Contra el Cancer
city: Moshi
country: Tanzania
facility: Kilimanjaro Christian Medical Centre
city: Lusaka
country: Zambia
facility: University Teaching Hospital
Study officials:
affiliation: Duke University
name: Nirmala Ramanujam, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04224324: The Effect of Pediatric Patient Temperament on Postoperative Outcomes
Official title: The Effect of Pediatric Patient Temperament on Postoperative Outcomes
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Emergence Delirium
Temperament
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2020-01-13
Enrollment: 344
Sex: ALL
Minimum age (years): 2
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pediatric patients undergoing tonsillectomy and adenoidectomy at Boston Children's Hospital

Brief summary: The goal of this study is to determine if preoperative temperament is associated with postoperative pain, emergence agitation, emotional and behavioral changes, and overall parent satisfaction. This is a prospective observational study to assess preoperative temperament in pediatric patients undergoing tonsillectomy and adenoidectomy, gather demographic data, intraoperative data regarding surgical and anesthetic technique, and collect immediate postoperative data to assess pain, emergence agitation (EA), parental satisfaction as well as remote postoperative data to assess emotional and behavior changes. These data will be used to determine if patients with a specific temperament profile are more likely to experience increased pain, emergence agitation, emotional changes, and behavioral disturbances postoperatively.


Eligibility criteria: Inclusion Criteria:

* ASA I or II
* undergoing Tonsil and/or Adenoid Removal at Boston Children's Hospital

Exclusion Criteria:

* history of prematurity
* major chronic medical conditions
* neurological impairment or developmental delay
* parents/guardians who do not speak English or are unable to understand the questionnaires

Primary outcomes:
measure: Temperament
timeFrame: preoperative period
measure: Pain score
timeFrame: immediately post operative period
measure: emergence agitation
timeFrame: immediately post operative period
measure: post hospital behavior changes
timeFrame: up to 4 weeks after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
References:
Clinical trial NCT00412724: Development and Validation of the Food Acceptability Questionnaire
Official title: Development and Validation of the Food Acceptability Questionnaire
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: diet
acceptability
palatability
food
questionnaire
Food habits
Lead sponsor: Physicians Committee for Responsible Medicine
Sponsor class: OTHER
First posted: 2006-12-18
Enrollment: 189
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men and women following a theraputic diet for at least 1 month

Brief summary: The Food Acceptability Questionnaire (FAQ) is a self-report measure of palatability, ease of preparation, satisfaction, and perceived benefits and adverse effects related to a prescribed or self-selected diet. This study intends to develop a reliable and valid food acceptability questionnaire for use in clinical studies in which dietary interventions are administered.

Detailed description: Two hundred adult participants who follow a therapeutic diet will be recruited from the Washington DC area. Participants will be asked to rate their impression on the foods that they were eating in the past two weeks. Fifty participants will be chosen at random and asked to complete the questionnaire a second time, three weeks later, to assess reliability. Ratings will be used to assess the validity and reliability of the Food Acceptability Questionnaire (FAQ).

Eligibility criteria: Inclusion Criteria:

* Participants must be older than 18 years and follow any kind of therapeutic diet.

Exclusion Criteria:

* Those who have difficulty eating by themselves will be excluded. No vulnerable subjects will be included.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: Physicians Committee for Responsible Medicine
state: District of Columbia
Study officials:
affiliation: Physicians Committee for Responsible Medicine
name: Neal Barnard, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ahlgren SS, Shultz JA, Massey LK, Hicks BC, Wysham C. Development of a preliminary diabetes dietary satisfaction and outcomes measure for patients with type 2 diabetes. Qual Life Res. 2004 May;13(4):819-32. doi: 10.1023/B:QURE.0000021694.59992.a1.
citation: Stunkard AJ, Messick S. The three-factor eating questionnaire to measure dietary restraint, disinhibition and hunger. J Psychosom Res. 1985;29(1):71-83. doi: 10.1016/0022-3999(85)90010-8.
citation: White MA, Whisenhunt BL, Williamson DA, Greenway FL, Netemeyer RG. Development and validation of the food-craving inventory. Obes Res. 2002 Feb;10(2):107-14. doi: 10.1038/oby.2002.17.
citation: Norman GR, Sloan JA, Wyrwich KW. Interpretation of changes in health-related quality of life: the remarkable universality of half a standard deviation. Med Care. 2003 May;41(5):582-92. doi: 10.1097/01.MLR.0000062554.74615.4C.
Clinical trial NCT02101424: Monitoring of Overdose Patients With and Without Supplemental Oxygen in the Emergency Department
Official title: Monitoring of Overdose Patients With and Without Supplemental Oxygen in the Emergency Department
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Overdose
Keywords: Overdose
Emergency Department
Supplemental Oxygen
Pulse Oximeter
Capnography
Lead sponsor: Hennepin Healthcare Research Institute
Sponsor class: OTHER
First posted: 2014-04-02
Enrollment: 300
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: Patients presenting to the emergency department at an urban county hospital.

Brief summary: This study will compare the data from pulse oximeters to capnographers as they are used to monitor patients who are being observed in the Emergency Department for a suspected overdose of alcohol or other drugs. The investigators will compare monitor data from patients who are and are not on supplemental oxygen, the ability of the monitors to predict the occurrence of airway interventions, and to detect ventilator changes noted on the opposing monitor. There will not be any interventions during this study other than the collection of data from the monitors and observation of the care of patients.


Eligibility criteria: Inclusion Criteria:

* Airway is being monitored as a result of overdose

Exclusion Criteria:

* Under 18 years old
* Unable to give informed consent at baseline
* Prisoners

Primary outcomes:
measure: Airway Interventions Performed by ED Staff
timeFrame: 4 hours
measure: Pulse oximetry
timeFrame: 4 hours
measure: End tidal CO2
timeFrame: 4 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Hennepin County Medical Center
state: Minnesota
Study officials:
affiliation: Hennepin Healthcare Research Institute
name: James R Miner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06680024: Comparative Study Between Outcome of ICT Drainage and VATS in Management of Second Stage Empyema
Official title: Comparative Study Between Outcome of Inter-costal Tube Drainage and Video Assisted Thoracoscopic Surgery in Management of Second Stage Empyema
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Second Stage Empyema
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2024-11-08
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to compare between outcome of inter-costal tube drainage and video assisted thoracoscopic surgery in management of patients with second stage empyema.

It compares the outcome of both interventions in hospital stay, cost, wether need of decortication later on or not.


Eligibility criteria: Inclusion Criteria:

* Patients both adults and children diagnosed as Empyema thoracis in early stages based on clinical examination, imaging modalities and pleural fluid analysis

Exclusion Criteria:

* Empyema due to carcinoma, terminally ill patients, patients with severe respiratory distress at admission, patients not fit for surgery, patients with co morbid diseases like cardiac disorders and immunosuppression.

Primary outcomes:
measure: the length of hospital stay
timeFrame: From enrollment to 4 weeks
measure: cost of treatment of the patients' in each group
timeFrame: 4 weeks
measure: number of participants with needs of decortication later on or not, assessed by the chest X-ray and CT chest.
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01738724: Study of the Efficacy of Dienogest in the Treatment of Uterine Leiomyomas When Compared to Desogestrel and Goserelin
Official title: Abnormal Uterine Bleeding in Women With Uterine Leiomyomas: Open Randomized Clinical Trial Of Non Inferiority Between Oral Dienogest, Oral Desogestrel and Subcutaneous Goserelin
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Uterine Leiomyoma
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2012-11-30
Enrollment: 14
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators´aim is to assess whether the progestagen dienogest reduces leiomyoma volume and its associated symptoms to the same extent as gonadotropin releasing hormone (GnRH) analogs or the progestagen desogestrel or whether it is inferior to other drugs already in use.

Detailed description: Uterine leiomyoma is a very prevalent condition among women and, although it is mainly asymptomatic, it may be related to bothersome or debilitating symptoms, such as uterine bleeding and pelvic pain or pressure. The standard treatment is surgical (hysterectomy or myomectomy), but there has been continued interest on medical treatments. Progestagens have long been used to control bleeding associated to leiomyomas, but they have not been able to decrease myoma volume. GnRH analogs are well stablished agents, capable of controlling symptoms and decreasing the tumors´volume, but their use is limited by bone loss and menopausal symptoms. A newly introduced progestagen, dienogest, has been studied to treat endometriosis, but its effects on leiomyoma are only starting to be assessed. The investigators are aiming to compare dienogest with the GnRH analog goserelin and the progestagen desogestrel in a randomized trial to see how this new treatment compares with previously used drugs and whether it is similar, inferior or superior to them on controlling leiomyoma associated symptoms and decreasing leiomyoma volume.

Eligibility criteria: Inclusion Criteria:

* Women with 35 - 55 years of age
* Uterine volume between 50cc and 500cc
* Abnormal uterine bleeding probably associated to intramural uterine leiomyomas

Exclusion Criteria:

* Pregnancy
* Liver or kidney dysfunction
* Women with only submucosal or subserosal uterine leiomyomas
* Women with contraindications to any of the drugs (categories 3 and 4 of WHO eligibility criteria)
* Use of anticoagulants
* Others causes of abnormal uterine bleeding (endometrial pathology, cervical pathology)

Primary outcomes:
measure: Leiomyoma Volume
timeFrame: After 6 months of medical therapy
Secondary outcomes:
measure: Pictorial Blood Assessment Chart (PBAC) Score Reduction
timeFrame: After 6 months of medical therapy
measure: Number of episodes of vaginal bleeding
timeFrame: After 6 months of medical therapy
Other outcomes:
Locations:
Study officials:
affiliation: FMRP-USP
name: Luiz Gustavo O Brito, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00986024: Resistance and/or Endurance Training, What is Most Effective in Prevention of Cardiovascular Diseases?
Official title: Strength Training Versus Aerobic Interval Training to Modify Risk Factors of the Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Keywords: Exercise therapy
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
First posted: 2009-09-29
Enrollment: 31
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: TREATMENT

Brief summary: The aim of the present study was to evaluate the effects of aerobic interval training versus strength training or a combination of these regimes on factors comprising the metabolic syndrome in order to find the most effective exercise regime for patients with metabolic syndrome.

Detailed description: In the Western world, approximately 25% of young to middle-aged adults have metabolic syndrome. There seem to be a strong age-dependence in the prevalence of the metabolic syndrome, but the incidence rises rapidly within adolescents and middle-aged groups and follows the development of obesity in the general population. Metabolic syndrome confers an increased risk of coronary heart disease, cardiovascular disease, and premature death; therefore, effective and affordable strategies to combat the syndrome would be of great individual and social importance.

Despite the general agreement that moderate-intensity physical activity for a minimum of 30 min five days per week or vigorous-intensity aerobic physical activity for a minimum of 20 min three days a week promote and maintain health, the optimal training regime to treat metabolic syndrome and its associated cardiovascular abnormalities remains uncertain.

Eligibility criteria: Inclusion Criteria:

* Having metabolic syndrome according to international diabetes foundations definition (IDF).

Exclusion Criteria:

* Unstable angina pectoris
* Uncompensated heart failure
* Myocardial infarction during the past 4 weeks
* Complex ventricular arrhythmias
* Kidney failure

Primary outcomes:
measure: proinflammatory markers
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Norwegian University of Science and Technology
name: Ulrik Wisløff, md prof
role: STUDY_DIRECTOR
References:
citation: Stensvold D, Slordahl SA, Wisloff U. Effect of exercise training on inflammation status among people with metabolic syndrome. Metab Syndr Relat Disord. 2012 Aug;10(4):267-72. doi: 10.1089/met.2011.0140. Epub 2012 Mar 28.