louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02238366: Study To Assess Renewal Of Treatment In Patients Recently Diagnosed With Prostate Cancer
Official title: A Non-interventional, Multi-centric, Observational, Prospective Study to Collect the Criteria on Which Renewal of GnRH Analogue Treatment With Triptorelin (Diphereline 3.75mg or Diphereline pr 11.25mg) is Made in Patients Recently Diagnosed With Prostate Cancer Requiring Androgen Deprivation Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2014-09-12
Enrollment: 368
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: Men recently diagnosed with locally advanced or metastatic prostate cancer receiving ADT.

Brief summary: The purpose of this study is to collect some parameters which may help to provide guidance on how Androgen Deprivation Therapy (ADT) drugs are renewed and physician satisfaction.


Eligibility criteria: Inclusion Criteria:

* Adult men, ≥18 years old, with recently diagnosed locally advanced or metastatic prostate cancer scheduled to receive androgen deprivation therapy as monotherapy or as concomitant and adjuvant therapy in association with radiation therapy, with a 1 or 3 month GnRH analogue triptorelin formulation
* Expected survival \> 12 months.
* Patients having provided written informed consent.
* Patients mentally fit for completing a questionnaire.

Exclusion Criteria:

* Treatment with any investigational drug within the last 3 months before study entry or planning to participate in a study.
* Patients who already have been treated with a GnRH analogue within the last year.
* Patients with hypersensitivity to GnRH, GnRH analogue, triptorelin or its excipients.
* Patients with a contraindication according to SmPC.

Primary outcomes:
measure: Percentage of patients for whom the initial Gonadotropin-releasing Hormone (GnRH) analogue formulation has been renewed.
timeFrame: 1 month
measure: Percentage of patients for whom the initial GnRH analogue formulation has been renewed.
timeFrame: 3 months
Secondary outcomes:
measure: Percentage of patients for whom the initial GnRH analogue formulation has been renewed at each follow up visit
timeFrame: 6 and 12 months
measure: Percentage of patients that switched from a 1-month to a 3-months formulation
timeFrame: 3, 6, 12 months
Other outcomes:
Locations:
city: Arad
country: Romania
city: Bucharest
country: Romania
city: Cluj-Napoca
country: Romania
city: Constanta
country: Romania
city: Craiova
country: Romania
city: Iasi
country: Romania
city: Timisoara
country: Romania
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01223066: Macrolane Prospective Survey
Official title: A Multi-center, Non-interventional, Prospective Study to Monitor Long Term Safety in Female Subjects After Treatment With Macrolane Volume Restoration Factor 20 and/or Macrolane Volume Restoration Factor 30 in the Breasts.
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Females Recently Treated With Macrolane VRF in the Breasts
Keywords: Macrolane
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
Collaborators: name: Pharma Consulting Group AB
First posted: 2010-10-18
Enrollment: 0
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participating clinics will ask women who have been treated with Macrolane in the breasts in clinical practice, to participate in this survey.

Brief summary: The study objective is to evaluate the long term safety when Macrolane Volume Restoration Factor is used in female breasts in clinical practice.


Eligibility criteria: Inclusion Criteria:

* Females recently treated with Macrolane Volume Restoration Factor in the breasts.
* Signed informed consent

Exclusion Criteria:

* There are no exclusion criteria

Primary outcomes:
measure: Adverse events
timeFrame: up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Akademikliniken
Study officials:
affiliation: Akademikliniken Stockholm
name: Per Hedén, Md PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01757366: Safety and Efficacy of Ginsenoside Rg3 in Combination With First-line Chemotherapy in Advanced Gastric Cancer
Official title: Safety and Efficacy of Ginsenoside Rg3 in Combination With First-line Chemotherapy in Advanced Gastric Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Self Efficacy
Lead sponsor: Hebei Tumor Hospital
Sponsor class: OTHER
First posted: 2012-12-28
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Safety and Efficacy of Ginsenoside Rg3 in Combination with First-line Chemotherapy in Advanced Gastric Cancer.The purpose of this study is to assess the safety of Ginsenoside Rg3 in advanced gastric cancer, and whether it improves the efficacy of first-line chemotherapy.


Eligibility criteria: Inclusion Criteria:

1. Signed informed consent form
2. Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1;
3. Histologically or cytologically confirmed gastric cancer;
4. At least have one measurable disease(according to RECIST, Response Evaluation Criteria in Solid Tumors )
5. Life expectancy of at least 3 months;

Exclusion Criteria:

1. Received any prior treatment including Ginsenoside Rg3;
2. Active or uncontrolled infection;
3. Concurrent treatment with an investigational agent or participation in another therapeutic clinical trial;
4. Pregnant or lactating women.

Primary outcomes:
measure: Progression-free survival (PFS)
timeFrame: 1 years
Secondary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: 1 year
measure: Overall Survival (OS)
timeFrame: 3 year
Other outcomes:
Locations:
city: Shijiazhuang
country: China
facility: Hebei Tumor Hospital
state: Hebei
Study officials:
affiliation: Hebei Tumor Hospital
name: Wei Liu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00790166: Effects of Humidity (During CPAP Treatment) on Mucociliary Clearance in Patients With Obstructive Sleep Apnea
Official title: Effects of nCPAP With and Without Humidification on: Inspiratory Temperature, Humidity, Saccharine Transit Time, Nasal Lavage and in Vitro Mucus Properties in Patients With Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Obstructive Sleep Apnea
Lead sponsor: Fisher and Paykel Healthcare
Sponsor class: INDUSTRY
First posted: 2008-11-13
Enrollment: 4
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: That the level of humidification delivered to patients during CPAP treatment will alter the subjects mucociliary clearance rate and related mucus properties.


Eligibility criteria: Inclusion Criteria:

* Moderate to severe obstructive sleep apnea - Apnea Hypopnea Index (AHI) \> 15
* 75% of events during the diagnostic study must be obstructive

Exclusion Criteria:

* Currently using CPAP treatment OR have used it in the past 4 weeks
* Intolerance of CPAP and/or CPAP mask in the past or during the titration night
* Mouth breather (unable to breath through mouth for the study period)
* \< 18years old
* Nasal CPAP intolerance determined in the PSG-CPAP titration study
* Serious nasal issues
* Acute upper airway disease
* Smoker
* COPD
* Congestive heart failure
* Neuromuscular disease
* Stroke

Primary outcomes:
measure: mucociliary clearance.
timeFrame: pre and post cpap treatment with varying levels of humidity
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Faculty of Medicine: Pulmonology: University of Sao Paulo Hospital
Study officials:
affiliation: Faculty of Medicine: Pulmonology: University of Sao Paulo Hospital
name: Geraldo Lorenzi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00489866: Aripiprazole Augmentation of Antidepressants in PTSD
Official title: Aripiprazole Augmentation of Antidepressants in PTSD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: PTSD
Keywords: PTSD
Antidepressant
Aripiprazole
OEF
OIF
Lead sponsor: Durham VA Medical Center
Sponsor class: FED
First posted: 2007-06-21
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The proposed investigation will determine the therapeutic potential of aripiprazole augmentation to a stable antidepressant regimen for reducing posttraumatic stress disorder (PTSD) symptoms, cognitive symptoms, psychotic symptoms, and depressive symptoms in veterans with PTSD.


Eligibility criteria: Inclusion Criteria:

* Outpatient veterans with posttraumatic stress disorder (PTSD)
* Receiving treatment with an antidepressant at a stable dose for 4 weeks
* Male or female
* Ages 18-65 years old

Primary outcomes:
measure: Clinician Administered PTSD Scale (CAPS)
timeFrame: Week 2 and Week 6
measure: Brief Assessment of Cognition in Affective Disorders (BAC-A)
timeFrame: Week 2 and Week 6
measure: Positive and Negative Symptoms Scale (PANSS)
timeFrame: Week 2 and Week 6
Secondary outcomes:
measure: Connor-Davidson Resilience Scale (CD-RISC)
timeFrame: Week 2 and Week 6
measure: Beck Depression Inventory, Second Edition (BDI-II)
timeFrame: Week 2 and Week 6
Other outcomes:
Locations:
city: Durham
country: United States
facility: Durham VAMC 508 Fulton Street
state: North Carolina
Study officials:
affiliation: Durham VAMC
name: Christine E Marx, MD, MA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01070966: Vytorin Reexamination Study (0653A-174)
Official title: Re-examination Study for General Drug Use to Assess the Safety and Efficacy Profile of VYTORIN in Usual Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Primary Hypercholesterolemia and Homozygous Familial Hypercholesterolemia (HoFH)
Keywords: Atherosclerosis
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2010-02-18
Enrollment: 2089
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants with Primary Hypercholesterolemia and Homozygous Familial Hypercholesterolemia (HoFH) treated with Vytorin

Brief summary: This survey is conducted for preparing application material for re-examination under the Pharmaceutical Affairs Laws and its Enforcement Regulation, its aim is to reconfirm the clinical usefulness of VYTORIN through collecting the safety and efficacy information according to the Re-examination Regulation for New Drugs.


Eligibility criteria: Inclusion Criteria:

* Participants Who Receives Vytorin In Usual Medical Practice Within Local Label For The First Time

Primary outcomes:
measure: Percentage of Participants With Any Clinical and/or Laboratory Adverse Experiences While Taking VYTORIN® Within 14 Days After Treatment Discontinuation
timeFrame: Up to 14 days after the treatment discontinuation
measure: Mean Percent Change From Baseline to Treatment in Lipid Parameters
timeFrame: Baseline and up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04292366: Optimising Colorectal Cancer Screening Participation
Official title: Optimising Colorectal Cancer Screening Participation -A Randomised Controlled Trial of Invitation Procedures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Neoplasms
Keywords: mass screening
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2020-03-03
Enrollment: 60000
Sex: ALL
Minimum age (years): 50
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The aim of this study is to demonstrate the effectiveness of three and four-staged invitation procedures compared to two-staged procedures by combining pre-notifications and reminders. The RCT will be nested into the Danish colorectal cancer screening programme in the Central Denmark Region including men and women aged 50-74 years. Participants will consecutively be randomized into four arms in a 1:1 ratio. Intervention arm 1 will receive a pre-notification approximately ten days prior to intervention, invitation and one reminder (three-staged intervention), Intervention arm 2 will receive invitation, one reminder after 45 days and a second reminder three months after invitation (three-staged invitation procedure), Intervention arm 3 will receive pre-notification, invitation, reminder after 45 days and reminder after three months (four-staged invitation procedure). Finally, the forth arm will be a control group receiving usual care which invitation and one reminder 45 days after invitation (two-staged invitation procedure). Both pre-notifications and reminders are sent using digital mail.

The main out-come will be participation within 6 months after invitation.


Eligibility criteria: Inclusion Criteria:

* Invited for colorectal cancer screening

Exclusion Criteria:

-

Primary outcomes:
measure: Number of residents participating in colorectal cancer screening
timeFrame: Within six months after invitaiton
Secondary outcomes:
Other outcomes:
Locations:
city: Randers
country: Denmark
facility: Randers Regional Hospital
Study officials:
affiliation: Randers Regional Hospital
name: Berit Andersen, Professor
role: STUDY_DIRECTOR
References:
citation: Larsen MB, Hedelund M, Flander L, Andersen B. The impact of pre-notifications and reminders on participation in colorectal cancer screening - A randomised controlled trial. Prev Med. 2022 Nov;164:107229. doi: 10.1016/j.ypmed.2022.107229. Epub 2022 Aug 31.
Clinical trial NCT03639766: The Effect of Abobotulinum Toxin A on the Symptoms of Raynaud's Phenomenon
Official title: The Effect of Abobotulinum Toxin A on the Symptoms of Raynaud's Phenomenon, a Double-Blind Randomized Placebo-Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Raynaud Phenomenon
Keywords: Raynaud Phenomenon
AbobotulinumtoxinA
Lead sponsor: University of Central Florida
Sponsor class: OTHER
First posted: 2018-08-21
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a two-arm parallel assignment involves two groups of participants. One group/hand receives the abobotulinum toxin A, and the other group/hand receives a saline solution (control).
Primary purpose: TREATMENT

Brief summary: This study aims to investigate the effect of abobotulinum toxin A on the symptoms of Raynaud's phenomenon.

Detailed description: This prospective double-blind randomized control trial seeks to compare a single formulation of BoNT, aboboutlinum toxin A (Dysport), to a placebo saline group, studying the effect of BoNT on Raynaud's symptoms among a more diverse population to provide insight into the patients most likely to benefit from BoNT.

Eligibility criteria: Inclusion Criteria:

* Male or female adult between 18 and 80 years of age
* Must have health insurance
* Must have a current diagnosis of Raynaud's phenomenon

Exclusion Criteria:

* Allergy to abobotulinum toxin A or its components
* Diagnosis of myasthenia gravis
* Previously received abobotulinum toxin vaccine
* Previously undergone upper extremity vascular surgery (including surgical sympathectomy)
* Currently receiving aminoglycoside antibiotics
* Received abobotulinum toxin A treatment in either hand in the past 6 months
* Pregnant women
* Women currently breastfeeding
* Current tobacco smoker (use in the past 12 months)
* Unable to read and speak English
* Adults unable to consent
* Individuals who are not yet adults (infants, children, teenagers)
* Prisoners

Primary outcomes:
measure: Raynaud's Condition Score
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Orlando
country: United States
facility: UCF Health Lake Nona Office
state: Florida
Study officials:
References:
Clinical trial NCT06558266: Mental Imagery in Menstrual Cycle Phases
Official title: Comparison of Mental Imagery Ability According to Menstrual Cycle Phases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Menstruation
Mental Imagery
Menstrual Cycles
Lead sponsor: Izmir University of Economics
Sponsor class: OTHER
First posted: 2024-08-16
Enrollment: 168
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The universe of the study consists of female students studying at Izmir University of Economics. With the permission of the Dean of the Faculty of Health Sciences of Izmir University of Economics, an announcement e-mail will be sent to all female students to inform them about the study and a list of volunteers will be created via the participation link. 151 female students who meet the study criteria will be included with the systematic sampling method. An "Informed Volunteer Consent Form" will be obtained from individuals who accept to participate in the study.

Brief summary: Hormonal fluctuations occur during the menstrual cycle and can affect cognition. For example, an increase in estrogen levels has been reported to temporarily enhance auditory perception of newly formed stimuli. It has been suggested that fluctuations in hormone levels can alter cognitive performance throughout the menstrual cycle because these fluctuations impact the neurobiology of the brain regions involved in cognition and emotion processing. Mental imagery (MI) refers to the mental process in which an individual imagines performing a movement without actually executing the movement. The effects of hormonal fluctuations on cognitive-perceptual skills have been mentioned above. In light of the above information, this study was planned to examine the relationship between menstrual symptom characteristics and mental imagery ability and to compare women s mental imagery abilities according to the phases of the menstrual cycle.


Eligibility criteria: Inclusion criteria

* Being a woman between the ages of 18-25,
* Having a regular menstrual cycle,
* Being a volunteer Exclusion criteria
* Using neuropsychiatric medication that may affect perception and cognitive skills.

People who do not participate in any of the four assessments will be excluded from the study.

Primary outcomes:
measure: Motor Imagery Skill
timeFrame: In 1 month period
Secondary outcomes:
measure: Menstrual Symptoms
timeFrame: at baseline
measure: Menstrual Pain
timeFrame: at baseline
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Izmir University of Economics
Study officials:
affiliation: Izmir University of Economics
name: Seda Yakıt Yeşilyurt, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04223466: Video-assisted Thoracoscopic Thymectomy Versus Subxiphoid Procedure
Official title: Video-assisted Thoracoscopic Thymectomy Versus Subxiphoid Thymectomy: Short- Term and Long- Term Results
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Thymectomy
Keywords: Video-assisted thoracoscopic surgery
Subxiphoid approach
Lead sponsor: The Second Hospital of Shandong University
Sponsor class: OTHER
First posted: 2020-01-10
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Surgerys used in thymectomy for myasthenia gravis and anterior mediastinal tumours have become much less invasive in recent years. In our study, the surgical technique which resected the thymus below the xiphoid process and the technique which was regarded as conventional video- assisted thoracoscopic surgery (VATS) thymectomy was compared.


Eligibility criteria: Inclusion Criteria:

1. Thymoma with or without myasthenia gravis；
2. Generalized myasthenia gravis not sensitive to conservative medicine treatment;
3. Good cardiopulmonary function.

Exclusion Criteria:

1. Cardiopulmonary function can't bear surgery;
2. Generalized myasthenia gravis with MuSK(+).

Primary outcomes:
measure: Visual Analogue Scale of postoperative pain
timeFrame: within 3 days
measure: Operation time
timeFrame: one day
measure: The amount of blood loss
timeFrame: one day
measure: Duration of drainage
timeFrame: with 7 days
measure: Duration of hospital stay
timeFrame: with 7 days
Secondary outcomes:
measure: Complete remission rates
timeFrame: 5 years
measure: Recurrence rate
timeFrame: 5 years
measure: Overall survival
timeFrame: within 10 years
Other outcomes:
Locations:
city: Jinan
country: China
facility: Yunpeng
state: Shandong
Study officials:
References:
Clinical trial NCT00592566: Desmopressin and Dexamethasone Adjunctive Treatment for Leptospirosis
Official title: An Open Randomized Controlled Trial of Desmopressin, and Dexamethasone as Adjunctive Therapy in Patients With Pulmonary Hemorrhage Associated With Leptospirosis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Leptospirosis
Keywords: Severe leptospirosis
Pulmonary hemorrhage
Lead sponsor: Mahidol University
Sponsor class: OTHER
Collaborators: name: Thailand Research Fund
First posted: 2008-01-14
Enrollment: 64
Sex: ALL
Minimum age (years): 15
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background: Pulmonary involvement in leptospirosis has been reported to be on the increase and is emerging as the main cause of death due to leptospirosis in many countries, including Thailand.

Methods: A prospective randomized controlled trial of desmopressin or high dose dexamethasone as adjunctive therapy in patients with suspected pulmonary hemorrhage associated with leptospirosis was conducted between July 2003 and October 2006 at 5 hospitals in Thailand.


Eligibility criteria: Inclusion Criteria:

* adult patients (\> 14 years) with suspected severe leptospirosis
* patients who presented with acute fever (oral temperature more than 38.00 C for \<15 days) in the absence of an obvious focus of infection
* In the opinion of the attending physician might have pulmonary hemorrhage (i.e. history of hemoptysis, and/ or bilateral nodular or air space infiltration).

Exclusion Criteria:

* pregnant or breastfeeding
* those with history of bleeding disorder
* those who had underlying diseases such as chronic liver disease, diabetes mellitus
* those who received diuretic or glucocorticoid

Primary outcomes:
measure: Survival
timeFrame: during in hospital admission
Secondary outcomes:
measure: Days of mechanical ventilation
timeFrame: during hospital admission
Other outcomes:
Locations:
city: Mueng
country: Thailand
facility: Loei Hospital
state: Loei Province
Study officials:
affiliation: Loei Hospital, Loei, Thailand:
name: Kanigar Niwattayakul, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mahidol University
name: Yupin Suputtamongkol, MD
role: STUDY_CHAIR
References: