louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04875182: The Relationship Between Zonulin and Interleukin-8 Levels and Postoperative Delirium Development
Official title: The Relationship Between Zonulin and Interleukin-8 Levels and Postoperative Delirium Development in Patients Who Had Femur Fracture Surgery Under Regional Anesthesia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Delirium
Lead sponsor: Muğla Sıtkı Koçman University
Sponsor class: OTHER
First posted: 2021-05-06
Enrollment: 73
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Both male and female patients over 65 years of age who will undergo femur neck and inthertrocanteric fracture surgery with regional anesthesia

Brief summary: The relationship between zonulin and interleukin-8 levels and postoperative delirium development in patients who had femur fracture surgery under regional anesthesia

Detailed description: Patients who are over 65 years of age and scheduled for femur fixation surgery will be included in the study. Blood samples for zonulin and interleukin-8 levels will be taken at the day prior to the surgery. All patients will be evaluated by Delirium Rating Scale (DRS) for delirium development at the postoperative 1., 2. and 3. days. Patients with a DRS score over 14 points will be included in the Group Delirium. And second blood samples for zonulin and interleukin-8 levels will be taken at the time of diagnosis.

Postoperative pain scores of the patients will recorded by using a numerical rating scale (NRS).

Eligibility criteria: Inclusion Criteria:

* patients over 65 years with mini mental state score \> 21, undergoing femur fixation surgery

Exclusion Criteria:

* anticholinergic drug use, known epilepsy, Parkinson, Alzheimer's disease, dementia, cognitive function disorder

Primary outcomes:
measure: preoperative Zonulin
timeFrame: in the preoperative 24. hour
measure: postoperative Zonulin
timeFrame: At the postoperative 72. hour
Secondary outcomes:
measure: preoperative Interleukin-8
timeFrame: in the preoperative 24. hour
measure: postoperative Interleukin-8
timeFrame: At the postoperative 72. hour
Other outcomes:
measure: Postoperative pain
timeFrame: At the postoperative 0., 12., 24 hours
Locations:
city: Muğla
country: Turkey
facility: Muğla Sıtkı Koçman University
state: Menteşe
Study officials:
affiliation: Muğla Sıtkı Koçman University
name: Gökhan vural
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03758482: Biological Response to Meal Ingestion: Gender Differences
Official title: Factors That Determine the Responses to Meal Ingestion: Effect of Gender on Sensory and Metabolomic Responses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: meal ingestion
metabolomic responses
hedonic sensations
homeostatic sensations
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
First posted: 2018-11-29
Enrollment: 24
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: OTHER

Brief summary: Aim: to determine the effect of gender on the sensory and metabolomic responses to a standard probe meal. Participants (12 men and 12 women) will be instructed to eat a standard dinner the day before, to consume a standard breakfast at home after overnight fast, and to report to the laboratory, where the test meal will be administered 4 h after breakfast. Studies will be conducted in a quiet, isolated room with participants sitting on a chair. Participants will ingest a standard probe meal (750 Kcal). Perception of homeostatic sensations (hunger/satiation, fullness) and hedonic sensations (digestive well-being, mood) will be measured at 5 min intervals 10 min before and 20 min after ingestion and at 10 min intervals up to 60 min after the probe meal. Heart rate variability, blood pressure and body temperature were measured before and after the meal. Blood samples for metabolomic analysis were taken before and 30 min after the meal.


Eligibility criteria: Inclusion Criteria:

* Non obese

Exclusion Criteria:

* history of gastrointestinal symptoms
* prior obesity
* use of medications
* history of anosmia and ageusia
* current dieting
* alcohol abuse
* psychological disorders
* eating disorders

Primary outcomes:
measure: Fullness sensation induced by the probe meal
timeFrame: 1 day
Secondary outcomes:
measure: Change in hunger/satiety induced by the probe meal
timeFrame: 1 day
measure: Change in digestive well-being induced by the probe meal
timeFrame: 1 day
measure: Change in mood induced by the probe meal
timeFrame: 1 day
measure: Change in circulating metabolites induced by the probe meal
timeFrame: 1 day
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: University Hospital Vall d'Hebron
Study officials:
References:
citation: Pribic T, Azpiroz F. Biogastronomy: Factors that determine the biological response to meal ingestion. Neurogastroenterol Motil. 2018 Jul;30(7):e13309. doi: 10.1111/nmo.13309. Epub 2018 Feb 2.
Clinical trial NCT00810082: Randomized ActiveStep Clinical Evaluation
Official title: Randomized ActiveStep Clinical Evaluation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fall Prevention
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
First posted: 2008-12-17
Enrollment: 65
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to learn if using the ActiveStep™ treadmill reduces the number and severity of falls in older adults. This is a pilot study. The information collected will be used to support a grant application for a large multi-center trial in the future.


Eligibility criteria: Inclusion Criteria:

* Age 65 or older
* Referred for balance training

Exclusion Criteria:

* Age \< 65

Primary outcomes:
measure: Participants With at Least One Fall
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: Lebanon
country: United States
facility: Alice Peck Day Memorial Hospital
state: New Hampshire
Study officials:
affiliation: Dartmouth College
name: Jon D Lurie, MD, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Simbex Corporation
name: Richard M Greenwald, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05389982: Mobile Health Platform for Surveillance of Kidney Stone
Official title: Usage of a Mobile Health Platform for Surveillance of Kidney Stone Formers
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Stone, Kidney
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2022-05-25
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: We plan to investigate whether usage of a mobile health platform for surveillance of stone formers by itself or as an adjunct to standard office-appointments will improve patient compliance and adherence to treatment guidelines and ultimately improve patient care, satisfaction, quality of life, and decrease stone recurrence.


Eligibility criteria: Inclusion Criteria:

* over 18 years old
* urinary tract stone formers
* meet the AUA guideline indication for metabolic stone evaluation and surveillance
* willing to pursue treatment recommendations of a metabolic workup

Exclusion Criteria:

* patients without mobile phone capability to utilize GetWell Loop,
* physical or cognitive impairment precluding usage of mobile phone or answering of questionnaires
* non-English speaking
* inability to consent to the study

Primary outcomes:
measure: change in patient quality of life
timeFrame: 0 to 6 months
measure: change in patient quality of life
timeFrame: 0 to 12 months
measure: Change in overall stone health scale
timeFrame: 0 to 6 months
measure: Change in overall stone health scale
timeFrame: 0 to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
References:
Clinical trial NCT04180982: A Safety and Efficacy Study of SHR4640 and Febuxostat in Subjects With Hyperuricemia
Official title: A Phase II, MultiCenter, Double-Blind Study to Evaluate the Efficacy and Safety of SHR4640 and Febuxostat in Subjects With Hyperuricemia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Hyperuricemia
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-11-29
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of the study is to assess the Safety and Efficacy of SHR4640 and Febuxostat in patients with Hyperuricemia.


Eligibility criteria: Inclusion Criteria:

* Subject has a body mass index ≥18 and ≤30 kg/m2;
* Screening sUA value ≥8mg/dl;
* Subject has no clinically relevant abnormalities in vital signs, ECG, physical examination，imaging examination or safety laboratory values.

Exclusion Criteria:

* Subject known or suspected of being sensitive to the study drugs or its ingredient；
* ALT、AST、TBIL\>1.5ULN;
* History of kidney stones or screening kidney stones by B-ultrasound；
* History of malignancy；
* History of xanthinuria；
* Donated blood（≥400ml）within 3 months prior to screening or received transfusion of blood.

Primary outcomes:
measure: Adverse Events(AEs) and Serious Adverse Events(SAEs)
timeFrame: Up to week 4
Secondary outcomes:
measure: Percentage of subjects with a serum uric level≤360μmol/L
timeFrame: At week1, 2, 3 and 4
measure: Percentage change from baseline in serum uric level .
timeFrame: At week1, 2, 3 and 4
measure: Actual change from baseline in serum uric level
timeFrame: At week1, 2, 3 and 4
Other outcomes:
Locations:
Study officials:
affiliation: West China Hospital
name: Liu Yi
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01302782: The Effects of Normobaric Hypoxia on Blood Glucose Levels.
Official title: The Effects of Normobaric Hypoxia on Blood Glucose Levels.
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Glucose
Keywords: Altitude
Glucose
Lead sponsor: Mike O'Callaghan Military Hospital
Sponsor class: FED
First posted: 2011-02-24
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: We are recruiting male and female patients (MOFH personnel and DoD beneficiaries) whom are at least 18 years of age from the Nellis Air Force Base population.

Brief summary: The purpose of this research study is to observe whether there is a change in blood glucose levels in response to a 2 hour oral glucose tolerance tests (OGTT) during acute normobaric hypoxia (short term low oxygen levels at normal ambient air pressure).


Eligibility criteria: Inclusion Criteria (non-diabetics):

* Tricare Insurance Beneficiary (military insurance) receiving care at Nellis AFB
* 5 males with a BMI \< 25; 5 males with a BMI \> 25 at least 18 years of age (MOFH personnel and DoD beneficiaries).
* 5 females with a BMI \< 25; 5 females with a BMI \> 25 at least 18 years of age (MOFH personnel and DoD beneficiaries).

Exclusion Criteria (non-diabetics):

* History of abnormal fasting glucose.
* Pulmonary disease.
* Any medications that change glucose control to include systemic steroid and diabetic medications.
* History of claustrophobia.
* Pregnant or breast feeding.
* Non-English speaking.
* Physical inability to wear/use the ROBD2

Inclusion Criteria (diabetics):

-5 males and/or females, at least 18 years of age, that are type 2 diabetics (MOFH personnel and DoD beneficiaries).

Exclusion Criteria (diabetics):

* Pulmonary disease.
* History of claustrophobia.
* Pregnant or breast feeding.
* Non-English speaking.
* Physical inability to wear/use the ROBD2

Primary outcomes:
measure: Change in glucose levels at altitude
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Mike O'Callaghan Federal Hospital/Nellis Air Force Base
name: Travis Russell, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00200382: Phase II Study of Therapy With PS 341 in Patients With Advanced Stage Non Small Cell Lung Cancer
Official title: Phase II Study to Evaluate the Efficacy and Safety of Therapy With PS 341 in Patients With Advanced Stage Non Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Non-small Cell Lung Cancer
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
Collaborators: name: Millennium Pharmaceuticals, Inc.
First posted: 2005-09-20
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to develop new treatments that will hopefully result in the relief of symptoms and prolongation of life. For this reason, your doctors have offered you treatment with a new experimental drug called PS 341.


Eligibility criteria: Inclusion Criteria:

* Patients must have confirmed NSCLC (squamous, adeno- and large cell anaplastic carcinoma)stage III B or Stage IV.

No prior chemotherapy regimen Patients must have adequate organ and marrow function

Exclusion Criteria:

* Untreated symptomatic brain metastasis Patients with known HIV positivity

Primary outcomes:
measure: Response rate
Secondary outcomes:
Other outcomes:
Locations:
city: Fitchburg
country: United States
facility: HealthAlliance Hospitals
state: Massachusetts
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: Bronx
country: United States
facility: Albert Einstein Cancer Center
state: New York
city: Bronx
country: United States
facility: Jacobi Medical Center
state: New York
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
Study officials:
affiliation: Montefiore Medical Center
name: Rasim Gucalp, M.D.
role: STUDY_CHAIR
References:
Clinical trial NCT00963482: Smoking Cessation in Alcoholics
Official title: Secondary Prevention of Tobacco Dependence in Alcohol-dependent Patients - a Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Alcohol Consumption
Keywords: Smoking
Alcohol
Outcome
Harm reduction
Alcohol drinking
Treatment outcome
Treatment effectiveness
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2009-08-21
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Most alcohol-dependent individuals are heavy smokers. The aim of this study is to evaluate whether a specific smoking cessation program (based on cognitive-behavioral therapy) for inpatient alcohol-dependent smokers is more effective than a control condition (treatment as usual).

Detailed description: The study is designed as a randomised, controlled trial conducted in an inpatient alcohol treatment institution. Shortly after alcohol detoxification, smokers are offered to voluntarily participate in a smoking cessation program. Participation is possible if patients either want to stop smoking or to reduce their consumption for at least 50%. Patients are asked about their smoking behaviour at the following time points: at admission (T0), after finishing the smoking cessation program or the control condition (T1), one month later by phone (T2) and six months later in a closing meeting (T3). Urine samples and CO-breath controls are taken to check both nicotine and alcohol abstinence.

Eligibility criteria: Inclusion Criteria:

* alcohol-dependent
* smoker
* intend to stop or reduce smoking for at least 50%

Exclusion Criteria:

* taking part in another smoking cessation program
* being pregnant
* not able to understand instruction due to cognitive impairment

Primary outcomes:
measure: Number of Smoke-free Patients
timeFrame: 6 months
Secondary outcomes:
measure: Drinking in the Last 7 Days (Patients Report + Urine Sample)
timeFrame: 6 months
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Psychiatric Hospital of the University of Basel
Study officials:
affiliation: Psychiatric Hospital of the University of Basel
name: Gerhard A. Wiesbeck, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04912882: Prognosis Predicting of CRC Patients Based on Morphology and Molecular Biomaker of CTC
Official title: Prognosis Predicting of CRC Patients Based on Morphology and Molecular Biomaker of Circulating Tumor Cells
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Colorectal Cancer
Circulating Tumor Cell
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2021-06-03
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: I-IV stage colorectal cancer patients with resectable lesion(s) who not receive preoperative treatment

Brief summary: Detecting circulating tumor cells from I-IV stage colorectal cancer patients pre-and post-operatively. Analyzing the morphology and biomarkers of CTCs and builting prognosis predicting model based on the morphology and biomarkers of CTCs. Verifying the prognosis model by the survival data.


Eligibility criteria: Inclusion Criteria:

* Age 18-80 years;

Histologically proven colorectal carcinoma (TNM stage I-IV)

R0 resection is possible according to preoperative evaluation

Written informed consent for participation in the trial.

Exclusion Criteria:

* Primary tumor or metastases not able to be removed radically

Receiving any preoperative treatment (Including chemotherapy, radiotherapy and target therapy)

Have other malignant tumors meanwhile

Other previous malignancy within 5 years

Primary outcomes:
measure: Sensitivity
timeFrame: 1 year
measure: Specificity
timeFrame: 1 year
Secondary outcomes:
measure: AUC
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01097382: Sleep Satisfaction and Psychomotor Performance of Adults
Official title: National, Multicenter, Open Label, Phase IV, Before-after Design Study, in Adult Patients With Primary Insomnia to Evaluate Sleep Satisfaction and Psychomotor Performance After 1 Month of Treatment With Zolpidem CR (Ambien®CR) in 6 Sites in Argentina
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Sleep Disorders
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2010-04-01
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Primary Objective:

To assess sleep satisfaction before and after Zolpidem CR (Ambien CR) administration

Secondary Objective:

To assess Psychomotor Performance before and after Zolpidem CR (Ambien CR) administration


Eligibility criteria: Inclusion criteria:

* Patients consulting Psychiatrists (private or hospital) -whatever the reason for consulting- who present with chronic primary insomnia from the DSM IV (Diagnostic and Statistical Manual - Revision 4).
* Accepting to participate in the study and signing informed consent

Exclusion criteria:

* Pregnancy or breastfeeding.
* Current severe neuropsychiatric disorder (i.e. psychosis, obsessive compulsive disorder, major depression, dementia of Alzheimer or vascular type) according to DSM IV criteria.
* History of substance abuse or dependence (including alcohol) within the past year.
* Hypersensitivity to zolpidem or its excipients.
* Severe hepatic insufficiency
* Severe and/or acute respiratory insufficiency
* Myasthenia gravis.
* OTC (Over The Counter) sleep remedies or prescription sleep medications within 2 weeks or 5 half-life before screening.
* Severe medical illness.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Sleep satisfaction score (LSEQ = Leeds sleep evaluation questionnaire)
timeFrame: at Baseline, at V2 (26 +/- 2 days)
Secondary outcomes:
measure: Psychomotor Performance (DSST / Digit Symbol Substitution Test and ESS / Epworth Sleepiness Scale)
timeFrame: at Baseline, at V2 (26 +/- 2 days)
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Investigational Site Number 10
city: C.a.b.a.
country: Argentina
facility: Investigational Site Number 1
city: C.a.b.a.
country: Argentina
facility: Investigational Site Number 4
city: C.a.b.a.
country: Argentina
facility: Investigational Site Number 6
city: Capital Federal
country: Argentina
facility: Investigational Site Number 2
city: La Plata
country: Argentina
facility: Investigational Site Number 3
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: