louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05224622: Detection of COVID-19 Using Breath Analysis - Validation Study.
Official title: Detection of the 2019 Novel Coronavirus (SARS-CoV-2) Using Breath Analysis - Validation Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
Lead sponsor: Scentech Medical Technologies Ltd
Sponsor class: INDUSTRY
First posted: 2022-02-04
Enrollment: 192
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Detection of the 2019 novel Coronavirus (SARS-CoV-2) using breath analysis - Validation study.

Detailed description: A diagnostic prospective single-site study, with no anticipated risks or constraints.

Primary objective- To validate the value of a set of breath VOC biomarkers that enable the investigator to distinguish between COVID-19 carriers and COVID-19 non-carriers in comparison to the gold-standard testing methodology.

Eligibility criteria: Inclusion Criteria:

* Age 18 to 75 years at the time of consent
* Capable of understanding written and/or spoken language
* Able to provide informed consent
* Was not treated with Anti-viral drugs

Exclusion Criteria:

* Age under 18 years old
* Under guardianship or deprived of liberty
* Pregnant or lactating woman

Primary outcomes:
measure: Presence of Volatile Organic Compounds indicating carriers of COVID-19.
timeFrame: Through the study completion, up to 3 months.
Secondary outcomes:
measure: Association of exhaled biomarkers with participants' characteristics (age, gender, symptoms-severity, etc.)
timeFrame: Through the study completion, up to 3 months.
Other outcomes:
Locations:
city: Poriyya
country: Israel
facility: Poriya Medical Center
Study officials:
affiliation: Poriya Medical Center
name: Avi Peretz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04252222: The VL3 Videolaryngoscope for Elective Tracheal Intubation in Adults
Official title: The VL3 Videolaryngoscope for Elective Tracheal Intubation in Adults: a Prospective Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Difficult Airway Intubation
Lead sponsor: Campus Bio-Medico University
Sponsor class: OTHER
First posted: 2020-02-05
Enrollment: 56
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: We conducted an observational prospective pilot study to assess the efficacy of the VL3 videolaryngoscope for routinely tracheal intubation in 56 adults, in terms of successful rate, no. attempts and manoeuvre duration, including both normal and difficult airways.


Eligibility criteria: Inclusion Criteria:

* Patients candidates for general anesthesia in elective surgery
* Age over 18 years
* ASA physical status I-III.

Exclusion Criteria:

* Paediatric population
* ASA physical status IV
* Emergency tracheal intubation

Primary outcomes:
measure: Tracheal intubation rate
timeFrame: 30 minutes
measure: Number of attempts
timeFrame: 30 minutes
measure: Total time of intubation
timeFrame: 15 minutes
measure: Time to glottis visualization
timeFrame: 15 minutes
measure: Cormack-Lehane grade
timeFrame: 15 minutes
Secondary outcomes:
measure: Need for external laryngeal pressure
timeFrame: 15 minutes
measure: Presence of post-laryngoscopy side effects
timeFrame: 3 days
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Università Campus Biomedico
Study officials:
References:
Clinical trial NCT00919022: Androcur Non-interventional Study Among Patients With Carcinoma of the Prostate
Official title: Prospective Observational Non-interventional Study of Correlation of Treatment With Androcur, Disease Stage, Testosterone Level, Age With Sexual Function and Erectile Dysfunction (Measured by IIEF-5 Validated Questionnaire)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Prostate Cancer
Keywords: Inoperable Prostate Cancer
Erectile Dysfunction
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2009-06-11
Enrollment: 194
Sex: MALE
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: Random sample of cancer patients visiting oncologist or urologist ambulance who are suitable for standard Cyproterone treatment.

Brief summary: Cyproterone acetate (CPA) is a steroidal antiandrogen which has affinity with progesterone and with glucocorticoid receptors. Cyproterone acetate is long-term proven effective treatment of inoperable carcinoma of the prostate.

Sexual functions remain very important in men with prostate cancer. However sexual functions are deteriorating fast with course of the disease. The influence of CPA on sexual functions remains controversial. IIEF-5 erectile dysfunction questionnaire is currently widely used validated simple scoring system for diagnosing of erectile dysfunction and belongs to most used systems in Czech Republic. At present there are no data on CPA influence on IIEF-5 scored erectile dysfunction within the use of its indication in prostate cancer.


Eligibility criteria: Inclusion Criteria:

* Males \> 18 years previously untreated with Androcur.
* No contraindication to Androcur.

Exclusion Criteria:

* Liver diseases, malignant liver tumours and wasting diseases (except for carcinoma of the prostate). A history of or existing thrombosis or embolism. Severe chronic depression. Hypersensitivity to cyproterone. Cyproterone acetate in previous therapy.

Primary outcomes:
measure: Correlation of treatment with Androcur (concomitant treatment), disease stage, testosterone level, age with erectile dysfunction (measured by IIEF-5 validated questionnaire)
timeFrame: 6 months
Secondary outcomes:
measure: Correlation of PSA level and erectile dysfunction
timeFrame: 6 months
measure: Sexual activity of Czech patients with inoperable prostate cancer
timeFrame: 6 months
Other outcomes:
Locations:
city: Many Locations
country: Czech Republic
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT03894930: Metta Meditation Training on Prosocial Behavior
Official title: Identifying Neural Correlates of Altruism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Social Behavior
Keywords: healthy subjects
prosocial
metta meditation
fMRI
Lead sponsor: Georgetown University
Sponsor class: OTHER
First posted: 2019-03-29
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of the study is to look at the impact of a metta meditation training on prosocial behavior and socio-affective brain responses. The training involves an 8-week, online administration of guided metta meditation practices aimed at generating feelings of kindness and compassion for other people. The study examines how participants respond to thinking about familiar others and strangers using behavioral and brain-imaging measures. This study will be important for understanding how people develop the capacity to be prosocial towards other individuals, which is a key component of adaptive social behavior.


Eligibility criteria: Inclusion Criteria:

* Is a medically healthy individual
* Lives in the Washington, D.C. metro area and is able to travel to Georgetown University

Exclusion Criteria:

* Has experience with meditation
* Has any MRI contraindication (e.g. metal in the body, cardiac pacemaker, cannot lie still, etc.)
* Has any neurological disease
* Has a current psychiatric disorder
* Is pregnant or planning to become pregnant
* Is on medication that affects the central nervous system (e.g. psychotropic drugs)

Primary outcomes:
measure: Social Discounting
timeFrame: 8 weeks
measure: Affective Brain Responses to Familiar and Unfamiliar Others
timeFrame: 8 weeks
Secondary outcomes:
measure: State Affect Rating
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Washington
country: United States
facility: Georgetown University
state: District of Columbia
Study officials:
affiliation: Georgetown University
name: Abigail A Marsh, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00945230: Actigraphic Measurement of a Neurosurgical Procedure
Official title: Analysis of Post Surgical Response in A Fifty-Six Year Old Female With An Incidental Large Left Anterior Cranial Fossa Meningioma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Disorders
Circadian Rhythm
Pain
Rehabilitation
Mood Lability
Keywords: Neurosurgical outcome
Actigraphy
Treatment Response Measurement
Lead sponsor: Child Psychopharmacology Institute
Sponsor class: OTHER
Collaborators: name: Mayo Clinic
First posted: 2009-07-24
Enrollment: 1
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The study examines and illustrates the utility of utilizing actigraphic measurements to assess treatment response.

Detailed description: Actigraphic measurements, repeated verbal fluency and multi-symptom operationally defined observations will be recorded for an 11 to 12 day baseline period and continued following neurosurgical tumor resection until a repeat MRI is completed three months after the procedure.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of incidental meningioma
* Single subject preparing to receive neurosurgical intervention

Exclusion Criteria:

* Inability to wear actigraphy device

Primary outcomes:
measure: Pre and Post Actigraphic and Systematic Observation Scale measurements
timeFrame: March 15, 2009-June 20, 2009
Secondary outcomes:
Other outcomes:
Locations:
city: Fargo
country: United States
facility: Child Psychopharmacology Institute
state: North Dakota
Study officials:
affiliation: Child Psychopharmacology Institute
name: Bill J Duke, M.A., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05318430: Subcutaneous Closed-Suction Drainage Affects Surgical Wounds Healing in Lower Gastrointestinal Open Surgery: a Randomized Controlled Study
Official title: Subcutaneous Closed-Suction Drainage Affects Surgical Wounds Healing in Lower Gastrointestinal Open Surgery: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: All Diseases That Require Gastrointestinal Open Surgery
Lead sponsor: Beijing Friendship Hospital
Sponsor class: OTHER
First posted: 2022-04-08
Enrollment: 228
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a single-center, randomized controlled trial to evaluate whether subcutaneous closed-suction drainage would decrease the incidence of poor surgical site healing in lower gastrointestinal open surgery. The independent risk factors of the incidence of poor surgical wounds healing in lower gastrointestinal open surgery will be analyzed.


Eligibility criteria: Inclusion Criteria:

* aged 18-85 years old, male or female
* all patients underwent lower gastrointestinal surgery: the digestive tract below Treitz ligament was called lower gastrointestinal tract, including jejunum, ileum, ileocecal part and colorectal
* open surgery (instead of laparoscopic) required
* willing participated in clinical verification and signed informed consent.

Exclusion Criteria:

* laparoscopic surgery
* upper gastrointestinal surgery (esophagus, stomach, duodenum and hepatobiliary pancreas)
* simple appendectomy / total appendectomy
* hernia surgery and intestinal obstruction surgery without intestinal resection
* infection of incision site before operation
* pregnant women
* expected death within 1 month after operation.

Primary outcomes:
measure: Rate of poor healing of incisions
timeFrame: Within 30 days after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Friendship Hospital, Capital Medical University
Study officials:
References:
Clinical trial NCT04405830: Outcome of Patients Treated With RRT
Official title: Outcome of Patients Treated With Renal Replacement Therapy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Kidney Injury
Cardiac Surgery
Lead sponsor: Nanjing Medical University
Sponsor class: OTHER
First posted: 2020-05-28
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients receiving RRT for renal support

Brief summary: Acute Kidney Injury (AKI) is a common serious complication after cardiac surgery. AKI not only prolongs the hospitalization time of patients undergoing cardiac surgery and increases the cost of treatment, but also is an independent risk factor for postoperative death. The aim of this study is to investigate the outcome of patients treated with renal replacement therapy (RRT), and to evaluate the short-term and long-term outcomes of patients with RRT.


Eligibility criteria: Inclusion Criteria:

* Critically ill patients undergoing cardiovascular surgery admitted to intensive care units.
* Patients receiving RRT for renal support
* Patients over 18 years of age

Exclusion Criteria:

* Patients \<18 years
* Refusal of consent

Primary outcomes:
measure: All-cause mortality
timeFrame: 30 days after Renal replacement therapy
Secondary outcomes:
measure: ICU Length of Stay (LOS)
timeFrame: from ICU admission to ICU discharge, within 30 days of admission
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The first affiliated hospital of nanjing medical university
state: Jiangsu
Study officials:
affiliation: First Hospital Affiliated to Nanjing Medical University
name: Yong-feng Shao, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02973230: Serum VEGF as a Tubal Pregnancy Marker
Official title: Serum Vascular Endothelial Growth Factor (VEGF) As a Marker for Tubal Pregnancy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy, Ectopic
Keywords: Pregnancy, Ectopic
Vascular Endothelial Growth Factor A
Pregnancy, Tubal
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2016-11-25
Enrollment: 90
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: The aim of the present study was (i) to evaluate whether a single measurement of VEGF would allow us to distinguish between intrauterine pregnancy (normal and abnormal) and EP and (ii) to correlate the levels of VEGF with serum levels of progesterone and β-hCG in each subgroup.

Ninety patients were selected from a population of women presenting to the Hospital das Clínicas of the University of São Paulo Medical School from October 2006 until September 2007 and were divided in three subgroups: (i) abnormal (arrested) intrauterine pregnancy (defined as a gestational sac greater than 16 mm of mean diameter without fetal tissue or a embryo greater than 5 mm without embryo cardiac activity); (ii) tubal pregnancy (no evidence of intrauterine pregnancy, presence of a adnexal mass, suboptimal rise of serum hCG levels in 48 hours); all tubal pregnancies were surgically treated and were histologically confirmed, they did not receive any methotrexate treatment before operation; (iii) normal intrauterine pregnancy (intrauterine gestational sac, embryo vitality confirmed).

Blood samples were collected by peripheral venous puncture before treatment; a total 15 mL of blood was withdrawn (2 mL for β-hCG, 3mL for progesterone, 10 mL for VEGF determinations). Blood samples for VEGF were collected in siliconized tubes and were allowed to coagulate at room temperature for 2-6 hours.


Eligibility criteria: Inclusion Criteria were:

* women that had a positive hCG test and presented with either abdominal pain or vaginal bleeding; all pregnancies were singletons, spontaneously conceived, with accurate assessments of their gestational age (42 - 56 days from the first day of the last menstrual period). A detailed informed consent was obtained from each patient before the inclusion.

Exclusion Criteria was:

* non-ampullar tubal pregnancy (surgically confirmed).

Primary outcomes:
measure: VEGF serum concentration
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: University of Sao Paulo - School of Medicine - General Hospital
Study officials:
References:
Clinical trial NCT00251030: A Study To Estimate The Effect Of Omeprazole On The Pharmacokinetics Of Nelfinavir In Healthy Subjects
Official title: A Study To Estimate The Effect Of Omeprazole On The Pharmacokinetics Of Nelfinavir In Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy Volunteers
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Jasper Clinic, Michigan
First posted: 2005-11-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To estimate the effects of omeprazole on the pharmacokinetics of nelfinavir in healthy subjects


Eligibility criteria: Inclusion Criteria:

* Healthy male or female subjects between the ages of 18 and 55 years.

Exclusion Criteria:

* Subjects with hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.

Primary outcomes:
measure: To estimate the effects of multiple doses of omeprazole on the steady-state pharmacokinetics of nelfinavir and M8 in healthy subjects
Secondary outcomes:
measure: To evaluate the safety and tolerability of the 625 mg formulation of nelfinavir when administered alone and with omeprazole
Other outcomes:
Locations:
city: Kalamazoo
country: United States
facility: Pfizer Investigational Site
state: Michigan
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT06094530: 18F-FAPI-RGD PET/CT in Various Tumor Types
Official title: Clinical Evaluation of 18F-FAPI-RGD PET/CT for Imaging of Fibroblast Activation Protein and Integrin avb3 in Various Tumor Types
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Neoplasms
Lead sponsor: Sichuan Provincial People's Hospital
Sponsor class: OTHER
First posted: 2023-10-23
Enrollment: 100
Sex: ALL
Minimum age (years): 10
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with clinically suspected or diagnosed tumors

Brief summary: The clinical feasibility of 18F-FAPI-RGD PET/CT will be evaluated in 100 patients with various types of tumor, and the results will be compared with those of 18F-FDG.

Detailed description: The aim of this study is to evaluate, in patients with various types of tumor, the radiotracer uptake and clinical feasibility of 18F-FAPI-RGD PET/CT compared with those of 18F-FDG PET/CT. To evaluate the diagnostic performance of 18F-FAPI-RGD and 18F-FDG PET imaging, the results of the visually interpreted PET images will be compared with the histopathologic results (via surgery or biopsy), which are used as the gold standard for the ﬁnal diagnosis. For patients for whom tissue diagnosis is not applicable, clinical and radiographic follow-up data will be used as the reference standard to validate the PET/CT ﬁndings.

Eligibility criteria: Inclusion Criteria:

* Patients with clinically suspected or diagnosed tumors

Exclusion Criteria:

* Hypertension that is difficult to control with medication, and systolic blood pressure exceeding 160mmHg
* Complicated with chronic liver disease, myocardial infarction, stroke
* Female patients who are pregnant (or attempting to become pregnant within six months), breastfeeding, or unwilling to use contraception
* Abnormal cardiopulmonary function or mental state, unable to tolerate prone lying for 20 minutes

Primary outcomes:
measure: Comparison of 18F-FAPI-RGD and 18F-FDG Uptake in Patients with different Tumors
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Departments of Nuclear Medicine, Sichuan Provincial People's Hospital
state: Sichuan
Study officials:
affiliation: Sichuan Provincial People's Hospital
name: Hao Wang, Doctor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00314730: Outcomes in the Palm of Your Hand: Improving the Quality and Continuity of Patient Care
Official title: Outcomes in the Palm of Your Hand: Improving the Quality and Continuity of Patient Care
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Computers, Handheld
Outcomes Assessment, Patient
Lead sponsor: University of Toronto
Sponsor class: OTHER
Collaborators: name: Ontario Ministry of Health and Long Term Care
name: Canadian Health Services Research Foundation
First posted: 2006-04-14
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study evaluates the usability of personal digital assistants (PDAs) by nurses for collecting, utilizing and communicating patient health information, and the feasibility of using PDAs to increase nurses' access to and utilization of best-practice guidelines.


Eligibility criteria: Inclusion Criteria:

* Nurses are eligible to participate if they work on a participating unit, 20 or more hours/week
* Patients are eligible if they are being cared for on a participating unit, are able to provide informed consent in English, and are able to answer questions about their daily activities and symptoms (pain, nausea, dyspnea, fatigue.)

Exclusion Criteria:

* none

Primary outcomes:
measure: nursing communication and coordination
measure: patient functional status
measure: patient symptoms (pain, nausea, dyspnea, fatigue)
measure: patient therapeutic self care
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
city: Toronto
country: Canada
facility: St. Joseph's Health Center
state: Ontario
Study officials:
affiliation: Professor, Faculty of Nursing, Univ of Toronto
name: Diane Doran, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References: