louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01858220: IS There a Correlation Between Sypmtoms of Gastroparesis and the Duration of Video Caspule Retention in the Stomach
Official title: Open Prospective Single Center Study for the Determination of Correlation Between Video Capsule Period of Retention in the Stomach and Symptoms of Gastroparesis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gastroparesis
Keywords: Gastroparesis
Small bowel video capsule
gastric retention
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2013-05-21
Enrollment: 100
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: Any patient undergoing small bowel video capsule examination for any indication

Brief summary: Gastroparesis is a syndrome characterized by delayed gastric emptying in absence of mechanical obstruction of the stomach. The cardinal symptoms include postprandial fullness (early satiety), nausea, vomiting, and bloating.Capsule endoscopy (CE) has evolved to become a first-line, noninvasive diagnostic technique for the small bowel. CE is now being utilized to assess patients for obscure gastrointestinal bleeding, possible Crohn's disease, celiac disease and small bowel tumors. Capsule endoscopy is preformed in a fasting state, and usually past the pylorus of the stomach into the duodenum after up to 30-40 minutes. The aim of the study is to determine the correlation between gasytoparesis symptoms to duration of capsule retention in the stomach


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Undergoing video capsule endoscopy for any indication

Exclusion Criteria:

-Endoscopic intraduodenal insertion of the capsule -

Primary outcomes:
measure: Duration of capsule retention in the stomach
timeFrame: End of capsule examination
Secondary outcomes:
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
Study officials:
References:
Clinical trial NCT03106220: Exercise Intervention - and Impact on Hospitalization
Official title: Exercise Intervention and Its Impact on Hospitalization - a Mulitcentered Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Sarcopenia
Debility Due to Disease
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2017-04-10
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: home exercise vs standard care with cross-over
Primary purpose: PREVENTION

Brief summary: Skeletal muscle abnormalities (sarcopenia) and frailty are common complications seen in patients with end-stage liver disease. The presence of these complications portends poor prognosis. The purpose of this study is to assess the impact of a formal home based video strengthening program (REST) on sarcopenia and frailty. We also want to assess the impact of this exercise program on complication rates, hospitalization, on quality of life (QOL) and on survival.


Eligibility criteria: inclusion= waitlisted for liver transplant with poor 6MWT

Exclusion criteria include: age \< 18 years, recent hospitalization (within 14 days) due to decompensation, variceal bleeding in the previous 1 month, large esophageal varices without primary prophylaxis, active excessive alcohol intake (in the previous 3 months), current overt uncontrolled hepatic encephalopathy, hepatopulmonary syndrome with uncontrolled hypoxia, portopulmonary hypertension, inability to perform exercise, or marked symptomatic comorbidities (cardiac, pulmonary, renal). multiorgan transplant

Primary outcomes:
measure: 6MWT
timeFrame: 3 months
measure: hand grip
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Kymberly D Watt
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00620620: Staccato Zaleplon Single Dose Pharmacokinetics
Official title: Safety, Tolerability, and Pharmacokinetics of a Single Dose of Staccato® Zaleplon for Inhalation in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy adult volunteers
Lead sponsor: Alexza Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2008-02-21
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to determine the safety, tolerability and pharmacokinetics of zaleplon delivered by the Staccato thermal aerosol system in healthy volunteers


Eligibility criteria: Inclusion Criteria:

* Male and female subjects between the ages of 18 to 55 years, inclusive who are in good general health

Exclusion Criteria:

* Subjects with a history of allergy or intolerance to zaleplon. Subjects who have any other disease or condition, by history, physical examination, or laboratory abnormalities that in the investigator's opinion, would present undue risk to the subject, or may confound the interpretation of study results.

Primary outcomes:
measure: Examine the tolerability and safety of Staccato Zaleplon in a healthy volunteer population;
timeFrame: Single dose
Secondary outcomes:
measure: Establish the plasma level-time profile (pharmacokinetics) of zaleplon in the target therapeutic range following single Staccato Zaleplon doses
timeFrame: single dose
Other outcomes:
Locations:
city: Evansville
country: United States
facility: Covance Clinical Research Unit Inc.
state: Indiana
Study officials:
affiliation: Alexza Pharmaceuticals, Inc.
name: Daniel A Spyker, MD
role: STUDY_DIRECTOR
References:
citation: Avram MJ, Spyker DA, Kehne JH, Cassella JV. The pharmacokinetics and pharmacodynamics of zaleplon delivered as a thermally generated aerosol in a single breath to volunteers. J Clin Pharmacol. 2013 Feb;53(2):140-50. doi: 10.1177/0091270012436886.
Clinical trial NCT04250220: eHealth-based Bavarian Alternative Detection of Atrial Fibrillation: A Randomized Controlled Trial (eBRAVE-AF)
Official title: eHealth-based Bavarian Alternative Detection of Atrial Fibrillation: A Randomized Controlled Trial (eBRAVE-AF)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: LMU Klinikum
Sponsor class: OTHER
Collaborators: name: Preventicus GmbH
name: Versicherungskammer Bayern
First posted: 2020-01-31
Enrollment: 4400
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Atrial fibrillation (AF) is the most common arrhythmia in western countries and causes of up to one quarter of ischemic strokes. The randomized eHealth-based Bavarian Alternative Detection of Atrial Fibrillation study (eBRAVE-AF) tests the efficacy of an e-health based strategy for the detection of AF. The e-health-based strategy consists of a smartphone-based photophlethysmographic (PPG) screening and an ECG-based validation.


Eligibility criteria: Inclusion Criteria:

* policy holders of a large health insurance company
* age ≥50 years
* CHA2DS2-VASc ≥1 (females ≥2)

Exclusion Criteria:

* atrial fibrillation
* oral anticoagulation

Primary outcomes:
measure: Number of participants with newly diagnosed atrial fibrillation within six months with prescription of oral anticoagulation
timeFrame: 6 months
Secondary outcomes:
measure: Number of participants with newly diagnosed atrial fibrillation
timeFrame: 6 months
measure: Number of participants with newly prescribed oral anticoagulation
timeFrame: 6 months
measure: Number of participants with stroke
timeFrame: 6 months
measure: Number of participants with thromboembolic events
timeFrame: 6 months
Other outcomes:
measure: Number of participants with TIMI major bleeding
timeFrame: 6 months
Locations:
city: München
country: Germany
facility: Klinikum der Universität München
Study officials:
affiliation: LMU Klinikum
name: Axel Bauer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rizas KD, Freyer L, Sappler N, von Stulpnagel L, Spielbichler P, Krasniqi A, Schreinlechner M, Wenner FN, Theurl F, Behroz A, Eiffener E, Klemm MP, Schneidewind A, Zens M, Dolejsi T, Mansmann U, Massberg S, Bauer A. Smartphone-based screening for atrial fibrillation: a pragmatic randomized clinical trial. Nat Med. 2022 Sep;28(9):1823-1830. doi: 10.1038/s41591-022-01979-w. Epub 2022 Aug 28.
citation: Freyer L, von Stulpnagel L, Spielbichler P, Sappler N, Wenner F, Schreinlechner M, Krasniqi A, Behroz A, Eiffener E, Zens M, Dolejsi T, Massberg S, Rizas KD, Bauer A. Rationale and design of a digital trial using smartphones to detect subclinical atrial fibrillation in a population at risk: The eHealth-based bavarian alternative detection of Atrial Fibrillation (eBRAVE-AF) trial. Am Heart J. 2021 Nov;241:26-34. doi: 10.1016/j.ahj.2021.06.008. Epub 2021 Jul 9.
Clinical trial NCT06959420: Knowledge, Attitudes, Perceptions and Behaviors of Healthcare Professionals and the General Population Regarding Vaccination During Febrile Illness
Official title: Knowledge, Attitudes, Perceptions and Behaviors of Healthcare Professionals and the General Population Regarding Vaccination During Febrile Illness
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Febrile Illness
Keywords: Vaccination
Immunization
Febrile illness
Mild fever
Efficacy
Safety
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2025-05-06
Enrollment: 630
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People in the general population and healthcare professionals concerned by vaccination.

Brief summary: Patients and healthcare professionals often lack adequate information regarding the possibility of vaccinating during febrile illnesses due to limited data. French guidelines on this topic remain vague, placing the responsibility for decision-making on healthcare professionals. This lack of clear guidance, combined with a perceived low urgency for vaccination in such cases, frequently leads to postponements, resulting in missed vaccination opportunities.

By investigating the knowledge, attitudes, perceptions, and behaviors of both patients and healthcare professionals, the investigators can identify obstacles and leverage incentives to promote vaccination during mild febrile illnesses. This approach could help reduce missed opportunities and improve vaccine coverage overall.


Eligibility criteria: Inclusion Criteria:

* Healthcare professionals : to administer vaccines as part of their usual practice
* General population: adults aged 18 years old and over.

Exclusion Criteria:

* Healthcare professionals: professionals that do not vaccinate patients in their usual practice.
* General population : individuals under the age of 18 years old.

Primary outcomes:
measure: Population in favour of vaccination during febrile periods
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Saint-Etienne
country: France
facility: CHU Saint-Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Elisabeth Botelho-Nevers, Md PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03284320: Retrospective Study in Sarcoma Patients
Official title: Retrospective Study to Evaluate Efficacy and Safety of Trabectedin (Yondelis®) in Sarcoma Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sarcoma of Bone
Sarcoma of Soft Tissue
Keywords: Drug therapy
Treatment outcome
Adult
Lead sponsor: University Medicine Greifswald
Sponsor class: OTHER
Collaborators: name: PharmaMar
First posted: 2017-09-15
Enrollment: 514
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with soft tissue and bone sarcomas treated with Trabectedin

Brief summary: The objectives of this trial is to evaluate efficacy and safety of treatment with Trabectedin in a large cohort of German patients with soft tissue and bone sarcomas.


Eligibility criteria: Inclusion Criteria:

* Patients with histologically confirmed soft tissue or bone sarcomas treated with at least one cycle of Trabectedin in any line of therapy.
* Age ≥18years at start of therapy with Trabectedin
* Informed Consent
* Patients already deceased may be included when the treating physician is able to determine the presumptive consent

Exclusion Criteria:

* No follow-up data available

Primary outcomes:
measure: - Progression free survival (PFS)
timeFrame: At the time of every treatment documentation up to the end of treatment, approximately 2 years
measure: - Overall survival (OS)
timeFrame: At the time of every treatment documentation up to the end of treatment, approximately 2 years
Secondary outcomes:
measure: CTCAE (Common Terminology Criteria for Adverse Events) 4.03
timeFrame: At the time of every treatment documentation up to the end of treatment, approximately 2 years
Other outcomes:
Locations:
city: Greifswald
country: Germany
facility: University Medicine Greifswald, Department of Internal Medicine C
Study officials:
affiliation: University Medicine Greifswald
name: Daniel Pink, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sarcoma Center Berlin-Brandenburg; HELIOS Hospital Berlin Buch
name: Peter Reichardt, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pink D, Bertz-Lepel J, Busemann C, Bitz U, Reichardt P. Efficacy of trabectedin in patients with advanced or metastatic alveolar soft-part sarcoma. Onkologie. 2012;35(5):249-52. doi: 10.1159/000338342. Epub 2012 Apr 23.
Clinical trial NCT02157220: Prospective Double-blinded Randomised Comparison of Profix Mobile to Fixed Bearing Knee Replacements
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Lead sponsor: The University of New South Wales
Sponsor class: OTHER
First posted: 2014-06-05
Enrollment: 77
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 randomised control trial comparing two different prosthetic designs used in total knee arthroplasty. Participants were randomised to receive either of the two prostheses and then were followed up of a period of 7 years, looking at pain, range of motion and impact on quality of life. The literature and joint registry of Australia shows that one of the prosthesis may be inferior to the other. Our research team hypothesised that this was not the case and that previous elicited differences were related to other factors.


Eligibility criteria: Inclusion Criteria:

* patients presenting to a single orthopaedic surgeon with knee pathology, who were suitable candidates for total knee arthroplasty

Exclusion Criteria:

* refusal to participate
* other simultaneous surgery
* post traumatic osteoarthritis
* prior open knee surgery

Primary outcomes:
measure: Visual pain analogue score
timeFrame: 6 weeks
measure: Range of motion
timeFrame: 6 weeks
measure: Activities of Daily Living
timeFrame: 6 weeks
measure: X-ray analysis of joint alignment
timeFrame: 5-7 year
measure: Visual pain analogue score
timeFrame: 6 months
measure: visual pain analogue score
timeFrame: 12 months
measure: visual analogue pain score
timeFrame: 5-7 years
measure: range of motion
timeFrame: 6 months
measure: range of motion
timeFrame: 1 year
measure: range of motion
timeFrame: 5-7 years
measure: activities of daily living
timeFrame: 6 months
measure: activities of daily living
timeFrame: 1 year
measure: activities of daily living
timeFrame: 5-7 years
Secondary outcomes:
Other outcomes:
Locations:
city: Port Macquarie
country: Australia
facility: Dr Dean Pepper, orthopaedic surgeon private rooms
state: New South Wales
Study officials:
References:
Clinical trial NCT01873820: Tolerance of Two Forms of Vitamin C in Acid-sensitive Adults
Official title: A Randomized, Double-blind, Crossover Study Comparing the Tolerance of Two Forms of Vitamin C in Acid Sensitive Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tolerance
Keywords: Vitamin C
calcium ascorbate
ascorbic acid
Lead sponsor: NBTY, Inc.
Sponsor class: INDUSTRY
Collaborators: name: KGK Science Inc.
name: Moyad, Mark MD MPH
First posted: 2013-06-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to compare the tolerance of two forms of vitamin C in adults with sensitivity to acidic foods.


Eligibility criteria: Inclusion Criteria:

* Healthy as determined by laboratory results and medical history
* Females not of child bearing potential
* Self-reported sensitivity to acidic foods
* Agrees to consume a low vitamin C diet

Exclusion Criteria:

* Pregnant, breastfeeding, or planning to become pregnant during the trial
* Use of medications known to interact with vitamin C or cause epigastric effects
* Use of supplements containing containing vitamin C
* Duodenal ulcer or gastric ulcer, gastritis, hiatus hernia, or gastroesophageal reflux disease (GERD) within past 3 months
* Use of antacids and/or acid suppressors within 4 weeks of randomization
* History of irritable bowel syndrome and related disorders
* Alcohol use \> 2 standard alcoholic drinks per day; alcohol or drug abuse within the past year
* History of cardiac disease within the past 6 months
* History of or current diagnosis of cancer
* Uncontrolled hypertension
* Unstable renal and/or liver disease
* History of kidney stones
* Unstable psychiatric disorder
* History of or current immunocompromise
* History of hemoglobinopathies
* Participation in another clinical research trial \<30 days
* Abnormal liver function
* Serum creatinine \> 1.5 x upper limit of normal (ULN)
* Anemia of any etiology
* Uncontrolled and/or untreated thyroid disorder
* BMI ≥ 35 kg/m2
* Unstable medications \<30 days
* Allergy or sensitivity to test article ingredients
* Cognitively impaired and/or unable to give informed consent

Primary outcomes:
measure: Change from Baseline Gastrointestinal Symptom Rating Scale at 5 and 10 days
timeFrame: 0, 5 and 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: Canada
facility: KGK Synergize, Inc
state: Ontario
Study officials:
affiliation: KGK Science Inc.
name: David Crowley, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05179720: The Application Research of Ultrasound Guided Puncture Stent Assisted Transperineal Prostate Biopsy
Official title: The Application Research of Ultrasound Guided Puncture Stent Assisted Transperineal Prostate Biopsy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
First posted: 2022-01-05
Enrollment: 560
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients in the experimental group used a puncture stent to assist transperineal prostate biopsy.
Primary purpose: DIAGNOSTIC

Brief summary: This study is a multi-center prospective study. Patients who meet the indications for prostate biopsy were included in this study.The study was randomly divided into two groups, one group was transperineal free-hand biopsy; the other group was puncture stent-assisted transperineal prostate biopsy. Exploring the positive rate of puncture stent-assisted transperineal prostate biopsy

Detailed description: This study is a multi-center prospective study. Patients who meet the indications for prostate biopsy were included in this study.The study was randomly divided into two groups, one group was transperineal free-hand biopsy; the other group was puncture stent-assisted transperineal prostate biopsy. Exploring the positive rate of puncture stent-assisted transperineal prostate biopsy 560 patients were enrolled. The main result is the positive rate of biopsy: including the detection rate of clinically meaningful prostate cancer and the detection rate of clinically insignificant prostate cancer.Secondary results include: (1)Biopsy complications include (infection, bleeding, etc.).(2)Pain score of biopsy patients (NRS score).(3) Biopsy time

Eligibility criteria: Inclusion Criteria:

Suspected prostate cancer patients Can tolerate prostate puncture

Exclusion Criteria:

Symptomatic acute or chronic inflammation of the prostate Patients with other cancers

Primary outcomes:
measure: positive rate of biopsy
timeFrame: 1 year
Secondary outcomes:
measure: Biopsy complications include (infection, bleeding, etc.)
timeFrame: 1 year
measure: Pain score of biopsy patients (NRS score)
timeFrame: 1 year
measure: Biopsy time
timeFrame: 1 year
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu hospital
state: Shandong
Study officials:
References:
Clinical trial NCT05890820: The Effect of Nutritional Risk Parameters on Postoperative Pulmonary Complications in Geriatric Thoracic Surgery Cases
Official title: Evaluation of the Effect of Preoperative Nutritional Risk Parameters on Postoperative Pulmonary Complications in Geriatric Patients Who Underwent Lung Resection for Malignancy, a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lung Cancer
Nutrition, Healthy
Postoperative Complications
Lead sponsor: Ankara Ataturk Sanatorium Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2023-06-06
Enrollment: 100
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients over 65 years of age with lung malignancy and undergoing thoracic surgery.

Brief summary: Preoperative evaluation of nutritional status in geriatric patients with lung cancer and implementation of these practices in elective patients are very important in terms of reducing postoperative complications and accelerating hospital discharge. For this purpose, many nutritional assessments and measurements are used. Our aim in this study was to evaluate the relationship between preoperative nutritional status and postoperative pulmonary complications in patients undergoing thoracic surgery for geriatric lung cancer.


Eligibility criteria: Inclusion Criteria:

* Patients over 65 years of age
* Lung Cancer
* Patients undergoing thoracic surgery

Exclusion Criteria:

* Refusal to participate in the study
* Patients with a diagnosis of hematological malignancy
* Patients with missing data required for research

Primary outcomes:
measure: FFMI - Fat-Free Mass Index
timeFrame: 24 hours
Secondary outcomes:
measure: BMI (Body Mass Index)
timeFrame: 24 hours
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Atatürk Sanatoryum Education and Research Hospital
state: Keçioren
Study officials:
References: