louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06802783: Impact of Procedure Materials on Patient Anxiety, Depression, and Pain in Prostate Biopsy Consent
Official title: Impact of Procedure Materials on Patient Anxiety, Depression, and Pain in Prostate Biopsy Consent
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Prostate Biopsy
Keywords: prostate biopsy
anxiety
pain
depression
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2025-01-31
Enrollment: 40
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The gold standard for diagnosing prostate cancer is an ultrasound-guided prostate biopsy. Despite its low complication rates, the procedure can cause significant stress, discomfort and anxiety in patients. This study aimed to determine whether visually introducing the materials (ultrasound, probe, biopsy needle) used during the biopsy could reduce patient anxiety and increase comfort.

Detailed description: Forty patients suspected of having prostate cancer were included in this prospective study. All patients received detailed information about the procedure, but they were divided into two groups. The first group was shown photographs of the devices alongside the written consent form, while the second group received only the written consent. The study compared the pain, depression and anxiety scores between the two groups

Eligibility criteria: Inclusion Criteria:

- patient's clinical data indicated the need for a prostate biopsy

Exclusion Criteria:

* included having a diagnosis of psychiatric illness
* having previously undergone a prostate biopsy under local anesthesia
* being a patient under active surveillance for prostate cancer

Primary outcomes:
measure: Anxiety Level
timeFrame: Pre-procedure
measure: Depression Level
timeFrame: Pre-procedure
measure: Pain Level
timeFrame: Pre procedure
Secondary outcomes:
measure: Anxiety Level
timeFrame: Immediately after the procedure
measure: Depression Level
timeFrame: Immediately after the procedure
measure: Pain Level
timeFrame: Immediately after the procedure
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University School of Medicine Urology Department
Study officials:
affiliation: MARMARA UNİVERSİTY SCHOOL OF MEDİCİNE DEPARTMENT OF UROLOGY
name: BAHADIR SAHIN
role: STUDY_DIRECTOR
References:
Clinical trial NCT00261183: The Contribution of Melatonin Vs. Placebo in Benzodiazepine Withdrawal in Methadone Maintenance Treatment Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Benzodiazepines
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2005-12-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: We hypothesized that patient will success in benzodiazepine withdrawal if they get melatonin to solve sleep-problems which commonly occur during benzodiazepine withdrawal. Former heroin addicts, currently in Methadone maintenance treatment, who are also abusing benzodiazepine, started self benzodiazepine withdrawal, and got for 6 weeks melatonin (5mg/day, taken every night) or placebo and after 1 week, additional 6 weeks with placebo or melatonin (double blind for what got first).Success The benzodiazepine withdrawal success was evaluated by urine for benzodiazepines, and sleep quality was evaluated using PSQI questionnaire (baseline,and after weeks 6, 7, 13)

Detailed description: A total of 100 patients will participate. Follow-up of benzodiazepines in urine after study and 6 months later will be evaluated, as well as sleep quality (using PSQI)

Eligibility criteria: Inclusion Criteria:

* Former opiates addicts, currently in methadone maintenance treatment, and abusing benzodiazepines who intend to withdrawal
* adults (\>=18y)

Exclusion Criteria:

* non abusing benzodiazepine
* Refuse making benzodiazepines withdrawal
* non methadone maintenance treatment patients

Primary outcomes:
measure: Stop benzodiazepine abuse(Urine)
Secondary outcomes:
measure: sleep quality (self report- PSQI)
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Shaul Schreiber
Study officials:
affiliation: Tel Aviv Medical Center
name: Shaul Schreiber, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Possemato K, Johnson EM, Emery JB, Wade M, Acosta MC, Marsch LA, Rosenblum A, Maisto SA. A pilot study comparing peer supported web-based CBT to self-managed web CBT for primary care veterans with PTSD and hazardous alcohol use. Psychiatr Rehabil J. 2019 Sep;42(3):305-313. doi: 10.1037/prj0000334. Epub 2018 Nov 29.
citation: Peles E, Hetzroni T, Bar-Hamburger R, Adelson M, Schreiber S. Melatonin for perceived sleep disturbances associated with benzodiazepine withdrawal among patients in methadone maintenance treatment: a double-blind randomized clinical trial. Addiction. 2007 Dec;102(12):1947-53. doi: 10.1111/j.1360-0443.2007.02007.x. Epub 2007 Oct 4.
Clinical trial NCT02016183: Candesartan Cilexetil / Hydrochlorothiazide Combination Tablets Special Drug Use Surveillance: Long-term Use (12 Months)
Official title: ECARD Combination Tablets LD&HD Special Drug Use Surveillance: Long-term Use (12 Months)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Keywords: Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2013-12-19
Enrollment: 3222
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: Patients with Hypertension

Brief summary: The purpose of this study is to evaluate the safety and efficacy of long-term use of candesartan cilexetil / hydrochlorothiazide combination tablets (ECARD) Combination Tablets LD\&HD in hypertensive patients in the routine clinical setting

Detailed description: This is a special drug use surveillance on long-term use of candesartan cilexetil / hydrochlorothiazide combination tablets (ECARD combination tablets) to evaluate in hypertensive patients in the routine clinical setting. Because the drug contains a diuretic (hydrochlorothiazide) , it is necessary to assess the safety, especially on serum uric acid. (the planned sample size is 3000).

The usual adult dosage is 1 tablet (4 mg/6.25 mg or 8 mg/6.25 mg as a candesartan cilexetil/hydrochlorothiazide) administered orally once daily. This drug should not be used as a first-line drug for hypertension treatment.

Eligibility criteria: Inclusion Criteria:

* Hypertensive patients

Exclusion Criteria:

(1) Patients with a history of hypersensitivity to ingredients of ECARD LD\&HD combination tablets, thiazides, or their analogues (e.g. sulphonamide derivatives such as chlortalidone) (2) Patients with anuria or patients under hemodialysis (3) Patients with acute renal failure (4) Patients with noticeably decreased Na and K levels in body fluids (5) Pregnant women or women planning to become pregnant

-

Primary outcomes:
measure: Number of Participants Who Experience at Least One Adverse Drug Reactions (ADRs)
timeFrame: Up to 12 months
Secondary outcomes:
measure: Changes From Baseline in Systolic Blood Pressure (SBP) at Each Time Point
timeFrame: Baseline, and Month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, and Final assessment (up to 12 months)
measure: Changes From Baseline in Diastolic Blood Pressure (DBP) at Each Time Point
timeFrame: Baseline, and Month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, and Final assessment (up to 12 months)
measure: Changes From Baseline in Pulse Rate at Each Time Point
timeFrame: Baseline, and Month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, and Final assessment (up to 12 months)
Other outcomes:
Locations:
city: Tokyo
country: Japan
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT04131283: Evidence of Spreading Vasoconstriction in Human Gingiva
Official title: Evidence of Spreading Vasoconstriction in Human Gingiva
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vasoconstriction
Oral Soft Tissue Conditions
Dental and Gingival Conditions
Keywords: spreading vasoconstriction
gingival microcirculation
Lead sponsor: Semmelweis University
Sponsor class: OTHER
First posted: 2019-10-18
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this study is to observe the mechanism of spreading vasoconstriction in human healthy gingiva. Epinephrine solution is applied on the attached gingiva in group "A" and on the surface of the tooth next to the ginvial sulcus in group "B". The different placement of the solution causes different effect in the microcirculation.

Detailed description: Spatial regulation of gingival microcirculation has not been revealed yet. Although this could be an important mechanism to protect gingiva as it is exposed to mechanical, chemical, thermal etc. irritation during whole life. It is especially important during flap surgery. Laser Speckle Contrast Imaging (LSCI) is novel non-invasive method with high spatio-temporal resolution, therefore it allows us to study remote effect of local vasoconstriction such as spreading vasoconstriction in human gingiva.

The epinephrine is a daily used vasoconstrictor material in dentistry and it will be used to trigger remote effect on gingiva. Epinephrine in 1 mg/ml concentration. Solution will be dropped on the gingiva at tooth 12 in a fabricated leakage proof well attached to 2mm above the marginal gingiva in group "A". The solution will be dropped on the surface of tooth 12 next to the sulcus into the well in case of group "B". The changes of the blood flow will be monitor at the test side with surrounding gingival area by LSCI. The control side in each case will be - appropriately to the test side - at tooth 21 with phisiologocal saline.

Eligibility criteria: Inclusion Criteria:

* at least 5 mm keratinized gingiva at the upper front teeth
* general health

Exclusion Criteria:

* pregnancy, breast-feeding
* any medication
* smoking, gingivitis, caries and coronal restoration with insufficient marginal integrity

Primary outcomes:
measure: Blood flow change after application of epinephrine
timeFrame: 30 minutes
Secondary outcomes:
measure: Comparsion of the change in blood flow between genders
timeFrame: 30 minutes
Other outcomes:
measure: Correlation between the change in blood flow and gingival thickness
timeFrame: 5 minutes
Locations:
city: Budapest
country: Hungary
facility: Janos Vag
Study officials:
References:
citation: Vag J, Ganti B, Mikecs B, Szabo E, Molnar B, Lohinai Z. Epinephrine penetrates through gingival sulcus unlike keratinized gingiva and evokes remote vasoconstriction in human. BMC Oral Health. 2020 Nov 4;20(1):305. doi: 10.1186/s12903-020-01296-z.
Clinical trial NCT03723083: Expanded Access for CC-2001
Official title: Expanded Access for CC-2001
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Dermatologic
Other
Keywords: Expanded Access
Compassionate Use
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2018-10-29
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: This is an expanded access program (EAP) for eligible participants designed to provide access to CC-2001.


Eligibility criteria: Inclusion Criteria:

-

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Summit
country: United States
facility: Celgene
state: New Jersey
Study officials:
References:
Clinical trial NCT03999983: Vertebral Artery Origin Treatment Via Endovascular Techniques Registry (VOTER)
Official title: Vertebral Artery Origin Treatment Via Endovascular Techniques Registry (VOTER)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Vertebral Artery Stenosis
Lead sponsor: St. Louis University
Sponsor class: OTHER
First posted: 2019-06-27
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted for stroke and evidence of Vertebral Artery Origin Stenosis (VAOS).

Brief summary: A retrospective and prospective registry of patients admitted for stroke and evidence of Vertebral Artery Origin Stenosis (VAOS).

Detailed description: A retrospective registry of stenting plus medical management for the prevention of recurrent stroke in patients with symptomatic Vertebral Artery origin Stenosis (VAOS). This study is collecting information on clinical outcomes up to 18 months post-treatment.

On January 6, 2025, VOTER was changed from prospective to retrospective.

Eligibility criteria: Inclusion Criteria:

1. Patients between 18 and 90 years of age
2. Patient has experienced a posterior circulation ischemic event
3. Patient has angiographically confirmed bilateral vertebral artery origin disease (Hypoplasia, occlusion, or stenosis).
4. Patient has \>50% stenosis on the side being targeted for therapy

Exclusion Criteria:

1. Pregnant women
2. Contrast Indication to the use of anti-platelet drugs
3. There is tandem vertebral or basilar artery stenosis
4. The serum creatinin is \>2.5
5. Baseline modified Rankin score is \>3
6. \< 5 years life expectancy

Primary outcomes:
measure: Incidence of recurrent stroke or death
timeFrame: 1 Year post-treatment
Secondary outcomes:
measure: Incidence of Restenosis
timeFrame: 1 Year post-treatment
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Baptist Medical Center Jacksonville
state: Florida
city: Tampa
country: United States
facility: University of Southern Florida
state: Florida
city: Winfield
country: United States
facility: Northwestern Medicine Regional Medical Group
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Bridgeton
country: United States
facility: SSM DePaul Hospital
state: Missouri
city: Saint Louis
country: United States
facility: Saint Louis University
state: Missouri
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Toledo
country: United States
facility: Mercy Health Neuroscience Institute
state: Ohio
city: Memphis
country: United States
facility: Semmes Murphey Clinic
state: Tennessee
city: El Paso
country: United States
facility: Texas Tech University Health Science Center of El Paso
state: Texas
Study officials:
affiliation: St. Louis University
name: Randall Edgell, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02842983: Pilot Study: Echocardiographic and Hemodynamic Effects of Esmolol in Septic Shock Patients
Official title: Pilot Study: Echocardiographic and Hemodynamic Effects of Esmolol in Septic Shock Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Shock, Septic
Keywords: Esmolol
Hypotension
Shock, Septic
Sepsis
Systemic Inflammatory Response Syndrome
Adrenergic beta-1 Receptor Antagonists
Adrenergic Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2016-07-25
Enrollment: 36
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: After initial hemodynamic stabilization, 36 septic shock patients with heart rate \> of 90 bpm and requiring norepinephrine to maintain mean arterial pressure (MAP) more than 65 mmHg will be randomised into two groups, esmolol group and control group. Patients allocated to esmolol group will receive a continuous esmolol infusion to maintain a lowering of heart rate of 10%. Norepinephrine will be titrated to achieve a MAP more than 65 mmHg. To investigate myocardial performance, the investigators will assess Tissue Doppler imaging by echocardiography and hemodynamic measures. Data will be obtained at baseline ,after esmolol infusion once achieved the predefined heart rate threshold and 72hours after esmolol infusion.

Detailed description: primary outcome were determined according to our previous study of tissue doppler.

Eligibility criteria: Inclusion Criteria:

* septic shock
* fluid optimization
* with a cardiac index \> 3 l/min/m2
* Heart Rate \>90 /min

Exclusion Criteria:

* Cardiogenic shock
* Bradycardia
* History of Severe Asthma
* Indications against Esmolol

Primary outcomes:
measure: Echocardiographic assessment of heart function
timeFrame: over a period of 72 hrs
Secondary outcomes:
measure: Effects on vasopressor requirement
timeFrame: over a period of 72 hrs
measure: 90-day hospital mortality
timeFrame: 90 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Yong-tai Liu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01702883: The Medication Experience Study
Official title: Using an Internet Survey to Improve Patient Adherence in Chronic Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Elevated Cholesterol
Diabetes
Depression
Keywords: prescriptions
hypertension
high cholesterol
diabetes
depression
adherence
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2012-10-10
Enrollment: 186
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: OTHER

Brief summary: The purpose of this study is to evaluate whether participation in an Internet-based intervention helps improve medication use.


Eligibility criteria: Inclusion Criteria:

* Any male or female 18 years or older, filling prescriptions for oral medications for hypertension, high cholesterol, diabetes, or depression at the Downtown Health Plaza, Piedmont Plaza, or Cancer Center Pharmacies.

Exclusion Criteria:

* Inability to complete Internet surveys due to inadequate Internet access, not understanding a survey written in English, or lack of computer skills.
* Patient does not intend to continue using the same WFBMC-affiliated pharmacy for the next 12 months.

Primary outcomes:
measure: The primary measure will be adherence as measured by pharmacy refills in each group.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Steve R Feldman, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00881283: Long-term Cardiovascular Risk in Cured Cushing's Patients
Official title: Role of Adipokines in Long-term Cardiovascular Risk in Cured Cushing's Patients
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Cushing's Disease
Keywords: Cushing's disease
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2009-04-15
Enrollment: 1
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Cured Cushing's disease

Brief summary: The purpose of this study is to determine whether subjects who have been affected by Cushing's disease in the past maintain some different characteristics compared with subjects who have never been diagnosed with the disease.


Eligibility criteria: Inclusion Criteria:

* patients who have been cured of Cushing's disease at least 5 years ago.

Exclusion Criteria:

* patients who have been cured of Cushing's disease more than 15 years ago.

Primary outcomes:
measure: adipokine measurements
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Neuroendocrine Clinical Center
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Anne Klibanski, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02019797: Desflurane-induced Myocardial Protection
Official title: Desflurane-induced Myocardial Protection in Aortic Valve Surgery: A Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Aortic Valve Stenosis
Keywords: aortic valve replacement
Lead sponsor: Keio University
Sponsor class: OTHER
Collaborators: name: Baxter Healthcare Corporation
First posted: 2013-12-24
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study examines pharmacological preconditioning and post conditioning of desflurane by comparing cardiac troponin release in patients receiving either desflurane or propofol for the aortic valve surgery.

Detailed description: Patients scheduled for aortic valve replacement with use of cardiopulmonary bypass are included in the study. Patients are assigned to desflurane group (Des) or propofol group (Prop). Des receives desflurane (1-2 MAC) inhalation between the induction of anesthesia and cardiopulmonary bypass (CPB). After the induction of CPB, the anesthesia in Des is switched to a total intravenous anesthesia (TIVA) with propofol. Prop receives a TIVA during the surgery. All patients receive a continuous infusion of remifentanil. Biomarker of myocardial damage troponin I is examined at 4 points; T1: after the induction of anesthesia, T2: arrival at ICU, T3: 12 hours after the ICU arrival, T4: 24 hours after the ICU arrival, T5: third post operative day (3POD).

Eligibility criteria: Inclusion Criteria:

* Patients scheduled for aortic valve replacement with use of cardiopulmonary bypass.

Exclusion Criteria:

* Patients younger than 20 years old.
* Recent myocardial infarction (within 1 year).
* Renal dysfunction (GFR less than 50ml/min).
* Known allergy to study drugs including propofol.

Primary outcomes:
measure: Troponin I
timeFrame: up to 3 days
Secondary outcomes:
measure: Length of ICU stay, Length of hospital stay
timeFrame: up to 2 months after the surgery
measure: Acute myocardial infarction
timeFrame: up to 7 days
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Keio University Hospital
Study officials:
affiliation: Keio University
name: Makoto Suematsu, M.D., Ph.D
role: STUDY_CHAIR
References: