louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04480580: Seroprevalence of SARS-Cov-2 in the Setting of a Non-dedicated COVID-19 Hospital in a Low CoV-2 Incidence Area: Implications for Surgery
Official title: Seroprevalence of SARS-Cov-2 in the Setting of a Non-dedicated COVID-19 Hospital in a Low CoV-2 Incidence Area: Implications for Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Surgery
SARS (Severe Acute Respiratory Syndrome)
Keywords: SARS-CoV-2, surgery
Lead sponsor: University of Cagliari
Sponsor class: OTHER
First posted: 2020-07-21
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients hospitalized in surgical department

Brief summary: We have herein analysed the patients admitted to our Department that underwent serologic tests for SARS-CoV-2 either by Ab or RT PCR, to estimate the prevalence of COVID-19 in the setting of a non-dedicated COVID-19 hospital and in a low CoV-2 incidence area, and to evaluate if security measures are necessary for this context.


Eligibility criteria: Inclusion Criteria:

* Patients hospitalized during pandemic spread

Exclusion Criteria:

* Incomplete data

Primary outcomes:
measure: Seroprevalence of SARS-CoV-2
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cagliari
country: Italy
facility: AOU Cagliari
state: CA
Study officials:
References:
Clinical trial NCT03493880: The Analysis of Immuno-Nutrition Index in Advanced Gastric Cancer Receiving Preoperative Treatments
Official title: The Analysis of Immuno-Nutrition Index in Advanced Gastric Cancer Receiving Preoperative Treatments: Observational Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gastric Cancer
Neoadjuvant Chemotherapy
Neoadjuvant Chemoradiotherapy
Systemic Inflammatory Response Syndrome (SIRS)
Nutrition Aspect of Cancer
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2018-04-11
Enrollment: 600
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: All the patients with advanced gastric cancer or esophagogastric cancer receiving neoadjuvant chemotherapy or chemoradiotherapy will be included for this observational study.

Brief summary: Based on multiple studies, the immune (systemic inflammation) and nutrition index were correlated with short- and long-term prognosis for gastric cancer. With the increasing application of preoperative treatments (chemotherapy and chemoradiotherapy), the issues concerning how are the immuno-nutrition index be altered under the effects of perioperative treatments and what are the clinical values of these index should be clarified.

Detailed description: The immune (systemic inflammation) index includes:

NLR (Neutrophil-to-Lymphocyte Ratio); PLR (Platelet-to-Lymphocyte Ratio); SII (Systemic Immune-Inflammation Index); GPS (Glasgow Prognostic Score); mGPS (modified Glasgow Prognostic Score); PI (Prognostic Index);

The nutrition index includes:

NRS2002; PNI (Prognostic Nutrition Index);

Eligibility criteria: Inclusion Criteria:

* Histologically confirmed adenocarcinoma
* Received neoadjuvant (preoperative) chemotherapy or chemoradiotherapy
* Diagnosed clinical advanced gastric cancer or esophagogastric cancer

Exclusion Criteria:

* Lack of immuno-nutrition data

Primary outcomes:
measure: Pathological response
timeFrame: One month after surgery
Secondary outcomes:
measure: 3-years overall survival
timeFrame: Three years after surgery
measure: 3-years disease-free survival
timeFrame: Three years after surgery
measure: Postoperative morbidity
timeFrame: One month after surgery
measure: yp TNM Stage
timeFrame: One month after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Cancer Hospital
state: Beijing
Study officials:
affiliation: Peking University Cancer Hospital & Institute
name: Jiafu Ji, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02875080: Evaluation Study of the Bioavailability of Brexpiprazole Orally Disintegrating Tablets in Healthy Male Subjects
Official title: A Single-center, Open-label, Randomized, Three-way, Crossover Trial to Evaluate the Bioavailability of Brexpiprazole (OPC-34712) Orally Disintegrating Tablets Relative to Brexpiprazole (OPC-34712) Conventional Tablets in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Adult Male
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2016-08-23
Enrollment: 18
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The ratios of the geometric means of the ODT formulation to those of the reference formulation (conventional tablet) for the bioavailability variables (Cmax, AUCt, and AUC∞ of brexpiprazole (OPC-34712)).


Eligibility criteria: Inclusion Criteria:

* Capable of providing written informed consent prior to initiation of any trial-related procedures, and able, in the opinion of the investigator, to comply with all requirements of the trial

Exclusion Criteria:

* Clinically significant abnormality at the time of screening (eg, significant deviation from reference ranges) or in medical history that, in the opinion of investigator or sponsor may place the subject at risk or interfere with outcome variables, including drug absorption, distribution, metabolism, and excretion
* History of serious mental disorder
* History of drug or alcohol abuse within 2 years prior to screening
* History of any significant drug allergy
* Use of an investigational drug within 120 days prior to the first dosing of trial drug
* Use of tobacco products or daily exposure to secondhand smoke within 2 months prior to screening
* Consumption of grapefruit, grapefruit products, Seville oranges, Seville orange products, starfruit, or starfruit products within 72 hours prior to dosing
* Use of prescription, over-the-counter, or herbal medication, vitamin supplements, or St. John's Wort within 14 days prior to the first dosing of trial drug, or of antibiotics within 30 days prior to the first dosing of trial drug
* History of major surgery of the digestive tract (excluding appendectomy)
* Any subject who, in the opinion of the investigator, should not participate in the trial

Primary outcomes:
measure: Maximum Plasma Concentration (Cmax) of OPC-34712
timeFrame: Predose, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96, 120，144, 168, 216, 264, and 312 hours postdose
measure: Area Under the Concentration-time Curve From Time Zero to Infinity (AUC∞) of OPC-34712
timeFrame: Predose, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96, 120，144, 168, 216, 264, and 312 hours postdose
Secondary outcomes:
Other outcomes:
Locations:
city: Kyusyu Region
country: Japan
Study officials:
affiliation: Otsuka Pharmaceutical Co., Ltd.
name: Hiroaki Ono, Mr
role: STUDY_DIRECTOR
References:
Clinical trial NCT05142462: Post Market Clinical Follow-up of EUROSCUP Fixe Acetabular Cup
Official title: Post Market Clinical Follow-up of EUROSCUP Fixe Acetabular Cup
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Hip Arthropathy
Hip Osteoarthritis
Hip Necrosis
Hip Fractures
Hip Dysplasia
Hip Arthritis
Lead sponsor: EUROS
Sponsor class: INDUSTRY
First posted: 2021-12-02
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient who fulfill the criteria of eligilibilty according to the instructions for use of EUROSCUP Fixe

Brief summary: EUROSCUP Fixe is intended for use in primary and revision total hip replacement surgery.

Hip replacement is intended to provide increased patient mobility and reduce pain by replacing the damages hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.

As part of post market vigilance, EUROS will collect data on EUROSCUP Fixe performances and safety

Detailed description: Post market observational study. This study is retropective and prospective, non comparative.

Eligibility criteria: Inclusion Criteria:

* Patient who received EUROSCUP Fixe.
* Patient informed of its participation to the study
* Patient aged between 18 and 80 years old (\<80).

Exclusion Criteria:

* Patient presenting a contraindication to EUROSCUP Fixe implantation.
* Patient who refused to participate to the study
* Vulnerable subjects

Primary outcomes:
measure: Safety of EUROSCUP Fixe
timeFrame: 1 year
Secondary outcomes:
measure: Clinical performances of EUROSCUP Fixe
timeFrame: 1 year
measure: Radiological performances of EUROSCUP Fixe
timeFrame: 1 year
measure: Survival of EUROSCUP Fixe
timeFrame: 10 years
Other outcomes:
Locations:
city: Agen
country: France
facility: Clinique Esquirol Saint Hilaire
city: Puilboreau
country: France
facility: Clinique de L'Atlantique
city: Seclin
country: France
facility: Centre Hospitalier SECLIN
city: Toulon
country: France
facility: Clinique St Roch
Study officials:
References:
Clinical trial NCT03245762: Intranasal Oxytocin for Infants With Prader-Willi Syndrome
Official title: Intranasal Oxytocin for Treatment of Infants and Children With Prader-Willi Syndrome in Nutritional Phase 1a - Phase 2 Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Prader-Willi Syndrome
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: Prader-Willi Syndrome Association
First posted: 2017-08-10
Enrollment: 15
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to compare the change in suck and swallow competency from baseline to morning of day 6 with intranasal oxytocin spray vs placebo in infants/children with Prader-Willi Syndrome who are in nutritional phase 1a. Videofluoroscopic swallow studies will be performed on treatment day 1 and on the day following treatment morning of day 6.

Detailed description: The overall objective of this Phase 2 trial is to compare the change from baseline to morning of day 6 of Internasal Oxytocin (IN-OT) on suck and swallow competency in infants/children with Prader-Willi Syndrome (PWS) who are in nutritional phase 1a.

Study Hypothesis 1: The Study team hypothesize that replacing Oxytocin (OT) in infants and children who are in nutritional phase 1a will improve their suck and swallow, potentially even eliminating the need for gastrostomy tubes and nasogastric tubes for feeding, and decreasing the risk of aspiration with oral feeding.

Study Hypothesis 2: The Study team hypothesize that replacing OT in infants and children with PWS will result in improved eye contact, daytime alertness, and feelings of bonding between the parents and the infant.

Eligibility criteria: Inclusion Criteria:

1. Individuals with genetically confirmed PWS who are in nutritional phase 1a, as determined by PI
2. Physical exam and laboratory results that are within the normal range.
3. Presence of a parent/caregiver/guardian that is able to consent for their participation.

Exclusion Criteria:

1. Exposure to any investigational agent in the 30 days prior to randomization.
2. Prior chronic treatment with oxytocin.
3. A medical condition that might interfere with the conduct of the study, confound interpretation of study results or endanger the subject's well-being.

Primary outcomes:
measure: Suck and Swallow Competency in Infants/Children With PWS Who Are in Nutritional Phase 1a
timeFrame: baseline to day 5
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Jennifer Miller, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02909062: Beyond Performance Status: Electronic Activity Monitoring to Assess Functional Activity of Patients With Gastrointestinal Malignancy During Chemotherapy.
Official title: Beyond Performance Status: Electronic Activity Monitoring to Assess Functional Activity of Patients With Gastrointestinal Malignancy During Chemotherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastrointestinal Cancer
Keywords: Electronic Activity Monitoring (EAM)
16-493
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2016-09-21
Enrollment: 54
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: MSK clinic

Brief summary: Electronic activity monitoring (EAM) devices are wearable electronic devices that monitor functional activity and provide personal feedback on activity progression. This study aims to determine if EAM can provide an objective, assessment of patient functional activity. The study will also examine the change in functional activity experienced by patients during the first cycle of chemotherapy. Another objective of the study will be to see if baseline functional activity and the change in functional activity that occurs during the first cycle of chemotherapy can be used to predict patient tolerability of subsequent cycles of chemotherapy.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of gastrointestinal malignancy.
* Age ≥ 18 years
* Planned to receive systemic chemotherapy, either adjuvant chemotherapy, or neoadjuvant chemotherapy, or any new line of chemotherapy in the setting of advanced disease. Subjects may enroll prior to chemotherapy or during the first cycle of treatment.

Exclusion Criteria:

* Restricted mobility defined as dependence or anytime use of a walker or wheelchair in the past three months.
* Refusing systemic chemotherapy.
* Concurrent radiotherapy with chemotherapy
* Have received at least one cycle of chemotherapy in the current chemotherapy regimen.

Primary outcomes:
measure: EAM Max Step-count On-Chemotherapy - EAM Max Step-count Pre-Chemotherapy
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Commack
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Rockville Centre
country: United States
facility: Memorial Sloan Kettering Rockville Centre
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Armin Shahrokni, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05754762: Median Effective Dose of Remifentanil for the Prevention of Myoclonus Induced by Etomidate Injection
Official title: Median Effective Dose of Remifentanil for the Prevention of Myoclonus Induced by Etomidate Injection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Etomidate
Myoclonus
Lead sponsor: Yangzhou University
Sponsor class: OTHER
First posted: 2023-03-06
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Since its introduction in 1973, etomidate has been widely used in clinical anaesthesia, especially in haemodynamically unstable patients, as a new anaesthetic induction drug with the advantage of low circulatory and respiratory depression. When administered via intravenous injection, etomidate can cause adverse effects such as injection pain and myoclonus. The incidence of myoclonus is still reported to be as high as 50-80%. Myoclonus caused by etomidate may cause discomfort during induction of anaesthesia and reduce perioperative satisfaction, and may lead to syringe dislodgement, extravasation of the injected drug, swelling at the injection site, delayed induction of anaesthesia and, in severe cases, cardiovascular adverse events. Therefore, the myoclonus and limb retraction reactions caused by etomidate are a key concern for clinical anaesthesiologists and need to be addressed at a time when comfort anaesthesia is being promoted. The aim of this study was to reduce myoclonus produced by etomidate injection during induction of general anaesthesia in surgical patients and to investigate the half effective dose of remifentanil to reduce etomidate myoclonus.


Eligibility criteria: Inclusion Criteria:

1. Ages ranged from 18 to 80.
2. ASA # or # level.

Exclusion Criteria:

* Allergy or contraindication to remifentanil or rocuronium; required for Central venipuncture catheterization;
* Abnormal liver or kidney function;
* Heavy drinking and long-term use of sedatives, analgesics or anti-anxiety drugs;
* Hearing and language impairment;
* Peripheral vascular disease;
* Severe cardiovascular disease or neurological disorders;
* Failure of one-time peripheral venipuncture;
* Infection of hand or wrist skin.

Primary outcomes:
measure: The presence of myoclonus
timeFrame: an average of 2 minutes
Secondary outcomes:
measure: The levels of myoclonus
timeFrame: an average of 2 minutes
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03665662: Effect of Intra-procedure Music on Anxiety
Official title: Effect of Intra-procedure Music on Anxiety for Interventional Radiology Procedures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2018-09-11
Enrollment: 139
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to examine the effects of intra-procedure music intervention on procedural anxiety, physiological stress and sedation requirements in patients undergoing moderate sedation procedures. Study participants will be randomly assigned into two groups: 1. Control - standard care without music intervention. 2. Intervention - standard of care plus music intervention. The State-Trait Anxiety Inventory questionnaire will be provided pre, intra and post procedure to all subjects in addition to an exit survey.


Eligibility criteria: Inclusion Criteria:

* Adult (\>18 years old) patients
* Scheduled for moderate sedation procedures in the Interventional Radiology department at Tisch Hospital, NYU Langone Health in New York, New York
* Able to read and write in English at a sixth grade level (STAI is written at sixth grade comprehension level)

Exclusion Criteria:

* Not a moderate sedation candidate (hemodynamically unfit, not optimized for procedure, pregnant)

Primary outcomes:
measure: State-Trait Anxiety Inventory (STAI) score
timeFrame: Up to 12 months
Secondary outcomes:
measure: Heart rate
timeFrame: Up to 12 months
measure: Respiration rate
timeFrame: Up to 12 months
measure: Blood pressure
timeFrame: Up to 12 months
measure: Amount of sedation required
timeFrame: Up to 12 months
measure: Pain score
timeFrame: Up to 12 months
measure: RASS score
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Institutional Review Board Operations (IRB)
state: New York
Study officials:
affiliation: NYU Langone Health
name: Leora Horwitz, MD, MHS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01705262: Comparing Oral Preparation With Macrogol (Moviprep) and Natriumdihydrogenphosphatdihydrat (Phosphoral)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Colonoscopy
Keywords: compliance
Bowel preparations
Moviprep
Phosphoral
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2012-10-12
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients referred to colonoscopy by the house doctors

Brief summary: The purpose of this study is to determine whether Moviprep or Phosphoral is the best method of bowel preparation before colonoscopy - seen by the patients and by the endoscopist.


Eligibility criteria: Inclusion Criteria:

* primary diagnostic colonoscopy,
* colonoscopy as a follow-up,
* intended therapeutic colonoscopy.

Exclusion Criteria:

* patients younger than 18 years
* pregnancy
* known bowl obstructions
* known inflammatory colon disease
* known kidney disease
* phenylketonuri
* glucose-6-phospat deficiency

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Surgery department
Study officials:
References: