louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00185484: Efficacy and Safety Oral Contraceptive Study
Official title: Multi-center, Open, Uncontrolled Study to Investigate the Efficacy and Safety of the Oral Contraceptive SH T 186 D Containing 0.02 mg Ethinylestradiol-b-cyclodextrin Clathrate and 3 mg Drospirenone in a 24-day Regimen for 13 Cycles in 1010 Healthy Female Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Contraception
Keywords: Oral contraception
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2005-09-16
Enrollment: 1113
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether the study drug is effective in prevention of pregnancy in healthy women in reproductive age

Detailed description: The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Eligibility criteria: Inclusion Criteria:

* Healthy woman requesting contraception
* Age between 18 and 35 years (inclusive), smokers maximum age of 30 years (inclusive)

Exclusion Criteria:

* Any conditions might interfere study outcome

Primary outcomes:
measure: Rate of unintended pregnancies (Pearl index)
timeFrame: 13 cycles of 28 days
Secondary outcomes:
measure: Physical and gynecological examination
timeFrame: screening, cycle 6 and final examination
measure: Vital signs
timeFrame: each visit
measure: Body weight
timeFrame: each visit
measure: Cervical smear
timeFrame: each visit
Other outcomes:
Locations:
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: Anttila L, Neunteufel W, Petraglia F, Marr J, Kunz M. Cycle control and bleeding pattern of a 24/4 regimen of drospirenone 3 mg/ethinylestradiol 20 mug compared with a 21/7 regimen of desogestrel 150 mug/ethinylestradiol 20 mug: a pooled analysis. Clin Drug Investig. 2011;31(8):519-525. doi: 10.2165/11590260-000000000-00000.
citation: Anttila L, Bachmann G, Hernadi L, Kunz M, Marr J, Klipping C. Contraceptive efficacy of a combined oral contraceptive containing ethinyloestradiol 20 mug/drospirenone 3mg administered in a 24/4 regimen: a pooled analysis of four open-label studies. Eur J Obstet Gynecol Reprod Biol. 2011 Apr;155(2):180-2. doi: 10.1016/j.ejogrb.2010.12.037. Epub 2011 Feb 1.
Clinical trial NCT04588584: Prescribing Practice of Medication - Patient View.
Official title: Prescribing Practice of Medicinal Products From the Perspective of the Patient.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Focus: Prescribing Practice
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2020-10-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 100 patients in the primary care clinic

Brief summary: In the clinical routine of a hospital, there are often problems dealing with medication that has already been prescribed at the time of admission due to incomplete or missing medication lists from the family doctor. Often patients forget this list at home.

This pilot study focuses on the medication process from admission to discharge and patient health literacy.


Eligibility criteria: Inclusion Criteria:

* Patient hospitalised at the clinical ward of Endocrinilogy and Diabetology and plastic Surgery
* Patient with an minimum of 2 days hospitalisation
* good knowledge of German
* Age 18 to 99 Years
* Male/female

Exclusion Criteria:

* Neurological or psychiatric primary disease e.g. Dementia
* Rehospitalisation 7 days after discharge from hospital
* Patients who need intensive care

Primary outcomes:
measure: Health competence of patients with focus on drugs.
timeFrame: 6 months
measure: Drug prescription from the view of the patient- Amount
timeFrame: 6 months
measure: Drug prescription from the view of the patient- Type of drugs
timeFrame: 6 months
measure: Drug prescription from the view of the patient- Discrepancies
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Graz
country: Austria
facility: LKH University clinical Graz , QM-RM
state: Styria
Study officials:
References:
Clinical trial NCT02858284: Evaluation of Safety and Efficacy of TUG (Therapeutic Ultrasound for Glaucoma) in the Treatment of Primary Open Angle Glaucoma or Ocular Hypertension
Official title: A Multi-Center, Randomized, Double-Masked, 8-week Pilot Study Evaluating the Safety and Efficacy of the TUG (Therapeutic Ultrasound for Glaucoma) Compared to Sham in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Glaucoma, Primary Open Angle
Ocular Hypertension
Lead sponsor: EyeSonix
Sponsor class: INDUSTRY
First posted: 2016-08-08
Enrollment: 25
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: The purpose of this study is to evaluate whether the TUG device is safe and effective in patients with primary open angle glaucoma or ocular hypertension.


Eligibility criteria: Inclusion Criteria:

* At least 18 years of age
* Diagnosis of primary open angle glaucoma or ocular hypertension in both eyes
* Be willing to discontinue disallowed products and/or medications during the period indicated prior to participation or throughout the study
* Be willing to provide written informed consent
* Be willing and able to follow instructions
* A negative urine pregnancy test and agree to an acceptable form of contraception for the duration of the study (if female of childbearing potential)

Exclusion Criteria:

* Any form of glaucoma other than primary open angle glaucoma or ocular hypertension in either eye
* Prior or anticipated concurrent use of an investigational drug or device
* Be currently pregnant, nursing, or planning a pregnancy; or be a woman that has a positive pregnancy test
* Have a condition (ocular or systemic) or a situation which, in the Investigator's opinion, may put the subject at increased risk, may confound study data, or may interfere significantly with the subject's study participation

Primary outcomes:
measure: Change in mean IOP
timeFrame: through subject study completion; average 2 months
measure: Change in mean diurnal IOP
timeFrame: Week 4 (Visit 5) and Week 8 (Visit 7)
measure: Change in IOP from baseline
timeFrame: through subject study completion; average 2 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04719884: Fluid Optimisation in Laparoscopic Colorectal Procedures
Official title: Fluid Optimisation in Laparoscopic Colorectal Procedures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Perioperative Complication
Keywords: postoperative complications, intraoperative monitoring, haemodynamic monitoring, laparoscopic abdominal surgery
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
First posted: 2021-01-22
Enrollment: 60
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: Goal-directed fluid therapy (GDFT) with hemodynamic monitoring may not be of benefit to all elective patients undergoing major abdominal surgery, particularly those managed in Enhanced Recovery After Surgery protocols (ERAS) setting.

Detailed description: Our study compared two groups of patients undergoing elective laparoscopic colorectal surgery: a control group (CG) in which standard haemodynamic monitoring was used, and a study group (SG) in which extended haemodynamic monitoring was applied with appropriate intraoperative interventions. Differences in intraoperative fluid management, hospital stay, and postoperative morbidity were observed.

Eligibility criteria: Inclusion Criteria:

* patients, undergoing elective laparoscopic colorectal surgery

Exclusion Criteria:

* Patients with cardiac arrhythmias

Primary outcomes:
measure: Duration of hospitalisation
timeFrame: 1 month after admission
Secondary outcomes:
measure: Perioperative complications
timeFrame: 8 days after surgery
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: University Medical Centre Ljubljana
Study officials:
affiliation: Department of anesthesiology and surgical intensive care
name: Alenka Spindler Vesel, asoc Prof
role: STUDY_CHAIR
References:
Clinical trial NCT00523484: Casodex/Zoladex Hormonal therApy Study for assessMent of Correlation Between PSA & BAI in prOstate Cancer patieNts
Official title: An Observational Study to Assess Correlation Between Prostate Specific Antigen & Beck Anxiety Index in Prostate Cancer Patients Under Hormonal Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Keywords: Beck Anxiety Inventory
Prostate Cancer
Prostate Specific Antigen
Naturalistic
Observational
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2007-08-31
Enrollment: 1200
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: Advanced prostate cancer patients who were being treated by hormonal agents

Brief summary: This study is an observational study to see whether anxiety level can be correlated with PSA level under the current practice in the patients of prostate cancer taking hormonal therapy. For assessment of anxiety level BAI(Beck Anxiety Inventory) will be used. The target population for this study is the patients of prostate cancer diagnosed previously and who are taking hormonal therapy with regular follow-up and PSA test. The follow-up duration will be total 6 months with interim visit at 3 month and final visit at 6 month.


Eligibility criteria: Inclusion Criteria:

1. Provision of written informed consent
2. Patients who take PSA test regularly
3. Observation suitable patients for PSA change according to hormonal treatment at least for 6months
4. Locally advanced or advanced prostate cancer patients who is suitable for hormonal therapy
5. Prostate Cancer Patients who has been taking one treatment among 3 hormonal therapies in below:

   * Bicalutamide Monotherapy : Bicalutamide 150mg/day
   * Goserelin 3.6mg/10.8mg
   * MAB(Maximal Androgen Blockade) :Bicalutamide 50mg + Goserelin 3.6/10.8mg

Exclusion Criteria:

1. Prohibition use under permitted indication
2. Previous inclusion in the present study
3. Participation in a clinical study during the last 30 days

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Kyunggi
country: Korea, Republic of
facility: Research Site
state: Anyang-si Dongan-gu
city: Seoul
country: Korea, Republic of
facility: Research Site
state: Jongro-gu
city: Seoul
country: Korea, Republic of
facility: Research Site
state: Songpa-gu
Study officials:
affiliation: AstraZeneca Korea
name: Miyoung Kim
role: STUDY_DIRECTOR
References:
Clinical trial NCT02279784: Drug Eluting Balloon in peripherAl inTErvention for Below-The-Knee Arteries With Freeway and Lutonix
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Peripheral Artery Disease
Lead sponsor: Ospedale San Donato
Sponsor class: OTHER
First posted: 2014-10-31
Enrollment: 160
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: The aim of this study is to compare in patients with critical limb ischemia the efficacy of angioplasty with different paclitaxel-eluting balloon devices for below-the-knee lesions in terms of restenosis.

Detailed description: Two devices will be evaluated: the Lutonix and the Freeway paclitaxel eluting balloons. A post-hoc analysis will compare the results with the historical data from DEBATE-BTK (NCT01558505).

Eligibility criteria: Inclusion Criteria:

* age\>18 years
* angiographic stenosis\>50% or occlusion of one below-knee vessel

Exclusion Criteria:

* allergy to Paclitaxel
* contraindication for combined antiplatelet treatment
* life expectancy \<1 year
* hypersensitivity or contraindication to one of the study drugs
* lack of consent
* need for amputation

Primary outcomes:
measure: number of events of angiographic binary restenosis
timeFrame: 12 months
Secondary outcomes:
measure: number of events of target lesion revascularization
timeFrame: 12 months
measure: number of events of death
timeFrame: 12 months
measure: frequency of major amputation
timeFrame: 12 months
Other outcomes:
Locations:
city: Arezzo
country: Italy
facility: Cardiovascular Department, Ospedale S.Donato
state: AR
Study officials:
References:
Clinical trial NCT01300884: Sierra High Definition Ano-Rectal Manometry
Official title: Sierra High Definition Ano-Rectal Manometry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Constipation
Fecal Incontinence
Lead sponsor: Augusta University
Sponsor class: OTHER
First posted: 2011-02-23
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We will recruit 20 healthy volunteers, 20 patients with fecal incontinence, 20 patients with constipation. Because anorectal disorders are more common in women, we will recruit approximately 8 men and 12 women in each group. Because it is possible subjects may sign consent but not participate in the study, or drop out of the study before completion, we will recruit a total of 80 subjects.

Brief summary: Hypotheses: High definition manometry (HDM) is safe and feasible in humans; HDM accurately characterizes anorectal anatomy and function in healthy humans; HDM provides comparable information regarding the structure and function of the anorectal region, to that obtained from ano-rectal manometry and anal ultrasonography (AUS), in patients with fecal incontinence or constipation.

Methods: 20 healthy volunteers, 20 patients with fecal incontinence, 20 patients with constipation will be recruited. Because anorectal disorders are more common in women, the investigators will recruit approximately 8 men and 12 women in each group. Each subject will undergo anorectal manometry, anal ultrasound and high definition manometry.

Data Analysis: Spearman correlational analysis will be performed to compare the parameters listed above. Also, the diagnostic yield of anal ultrasonography vs HDM in identifying anatomic sphincter defects will be assessed.


Eligibility criteria: Inclusion Criteria:

For patients:

1. Either fecal incontinence (the occurrence of at least one episode of involuntary discharge of stool matter per week) or constipation (Rome III criteria) (16,17)
2. Adults between the ages of 18-80 yrs.

For healthy volunteers:

1. Adults between the ages of 18-80 yrs
2. No gastrointestinal symptoms

Exclusion Criteria:

1. Rectal prolapse or anal fissure on physical examination
2. Recent pelvic or recto-anal surgery (\< 6 months ago)
3. History of pelvic irradiation.

Primary outcomes:
measure: To assess the feasibility of HDM in three groups of human subjects; healthy humans, patients with fecal incontinence and patients with chronic constipation
timeFrame: One visit
Secondary outcomes:
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
Study officials:
affiliation: University of Iowa
name: Satish SC Rao, MD, Phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02385084: A Study of LY2409021 Formulations in Healthy Participants
Official title: A Single Dose Pharmacokinetic Study of LY2409021 in Healthy Subjects to Bridge Formulations From Capsules to Commercial Tablets
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2015-03-11
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to measure how much of the new LY2409021 tablet formulations get into the blood stream and how long it takes the body to get rid of them, compared to the current LY2409021 capsule formulation. In addition, the safety and tolerability of both the new and current formulations will be evaluated. Information about any side effects that may occur will also be collected. The study has two parts. Each participant may enroll in one part only. The study will last up to 8 weeks for each participant. Screening is required prior to the start of the study.


Eligibility criteria: Inclusion Criteria:

* Overtly healthy males or surgically sterile or postmenopausal females, as determined by medical history and physical examination
* Have a body mass index (BMI) of 18.0 to 32.0 kilogram per square meter (kg/m\^2)
* Have clinical laboratory test results within normal reference range for the population or investigator site, or results with acceptable deviations that are judged to be not clinically significant by the investigator

Exclusion Criteria:

* Have known allergies to LY2409021, related compounds or any components of the formulation, or history of significant atopy
* Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study
* Have known or ongoing psychiatric disorders

Primary outcomes:
measure: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-inf]) of LY2409021
timeFrame: Day 1: Predose, 0.5 Hours (H), 1 H, 4 H, 8 H, 12 H, 24 H, 48 H, 72 H, 96 H, 144 H, 192 H, 264 H, 336 H Postdose in Each Period
measure: PK: Maximum Plasma Concentration (Cmax) of LY2409021
timeFrame: Day 1: Predose, 0.5 H, 1 H, 4 H, 8 H, 12 H, 24 H, 48 H, 72 H, 96 H, 144 H, 192 H, 264 H, 336 H Postdose in Each Period
Secondary outcomes:
Other outcomes:
Locations:
city: Daytona Beach
country: United States
facility: Covance CRU, Inc
state: Florida
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT02451384: According CTC to Compare the Influences of Different Methods to Remove the PDAC
Official title: To Compare the Influences of Different Methods to Remove the Pancreatic Ductal Adenocarcinoma With the Detection of Circulating Tumor Cells
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Carcinoma, Pancreatic Ductal
Circulating Tumor Cells
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2015-05-22
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Acccording circulating tumor cells to compare the differences of different methods(routine method、no-touch principle method、laparoscopy method) to remove the ductal adenocarcinoma of pancreatic body and tail.


Eligibility criteria: Inclusion Criteria:

* Ductal adenocarcinoma of pancreatic body and tail
* Tumor can be removed
* No other tumors and without liver metastases
* Age from 18 to 80 years old

Exclusion Criteria:

* Neoplasms with other sites of the pancreas
* With other tumors of any other sites

Primary outcomes:
measure: the changes of CTCs countings between the pre and post-operation in each arm
timeFrame: Within 1 week after the surgeries are completed in any arm
measure: the changes of CTCs countings between the pre and post-operation among the arms
timeFrame: Within 2 weeks after the surgeies are all completed
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Genaral surgery department of Zhongshan Hospital, Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Zhongshan Hospital Affiliated to Fudan University
state: Shanghai
Study officials:
References:
Clinical trial NCT02256384: Evaluation of Respiratory Acoustic Monitor in Children After Surgery
Official title: Evaluation of Respiratory Acoustic Monitor in Children After Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Complications
Pediatric
Keywords: Respiration Rate
Respiratory Acoustic Monitor
postoperative
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
Collaborators: name: Masimo Corporation
name: Children's Medical Center Dallas
name: University of Texas Southwestern Medical Center
First posted: 2014-10-03
Enrollment: 76
Sex: ALL
Minimum age (years): 2
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The study will evaluate the performance of measuring respiration rate with the Respiratory Acoustic Monitoring (RAM).

Detailed description: The study seeks to determine the reliability and accuracy of the acoustic respiratory monitoring (RAM) in comparison of clinically completed transthoracic impedance monitoring (TI) and manual counting of respiratory rate in postoperative pediatric patients at risk of adverse respiratory events.

Eligibility criteria: Inclusion Criteria:

* Male or female children 2 to 16 years of age
* In-patients or 23 hour short stay patients who had a tonsillectomy with a diagnosis or symptoms of obstructive sleep apnea or who had any surgery and receiving an opioid by patient controlled analgesia for post-operative pain control
* Child weighs at least 10 kg on day of surgery

Exclusion Criteria:

* Patient has skin abnormalities (rash, eczema, etc.) at the planned application sites that would interfere with sensor or electrode applications.
* Patient is admitted to the Intensive Care Unit
* Patient has tracheostomy
* Patient is on non-invasive ventilator support

Primary outcomes:
measure: Reliability/ Accuracy of Respiratory Acoustic Monitoring (RAM)
timeFrame: Up to 24 hours after surgery
Secondary outcomes:
measure: Presence of False Alarms
timeFrame: Up to 24 hours after surgery
measure: Tolerance of the RAM
timeFrame: Up to 24 hours after surgery
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Dallas
country: United States
facility: UT Southwestern Medical Center - Dallas
state: Texas
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Mario Patino, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UT Southwestern Medical Center- Dallas
name: Peter Szmuk, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Patino M, Kalin M, Griffin A, Minhajuddin A, Ding L, Williams T, Ishman S, Mahmoud M, Kurth CD, Szmuk P. Comparison of Postoperative Respiratory Monitoring by Acoustic and Transthoracic Impedance Technologies in Pediatric Patients at Risk of Respiratory Depression. Anesth Analg. 2017 Jun;124(6):1937-1942. doi: 10.1213/ANE.0000000000002062.