louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03957382: Evaluation of Safety and Efficacy of the Accero® (Heal) Stent for Intracranial Aneurysm Treatment
Official title: Evaluation of Safety and Efficacy of the Accero® (Heal) Stent for Intracranial Aneurysm Treatment
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Intracranial Aneurysm
Lead sponsor: Acandis GmbH
Sponsor class: INDUSTRY
First posted: 2019-05-21
Enrollment: 130
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients treated with Accero® (heal) Stent

Brief summary: This study is intended to show that the application of the Accero® (heal) stent is safe within the given indication.


Eligibility criteria: Inclusion Criteria:

Any patient treated with ACCERO® (heal) Stent according to IFU and has signed the informed consent

Exclusion Criteria:

- Patient is participating in another clinical trial

Primary outcomes:
measure: Raymond Roy Classification
timeFrame: 6 months after treatment
measure: Raymond Roy Classification
timeFrame: 12 months after treatment
measure: Raymond Roy Classification
timeFrame: 24 months after treatment
measure: Raymond Roy Classification
timeFrame: 36 months after treatment
Secondary outcomes:
measure: modified Rankin Scale (mRS)
timeFrame: 6 months after treatment
measure: modified Rankin Scale (mRS)
timeFrame: 12 months after treatment
measure: modified Rankin Scale (mRS)
timeFrame: 24 months after treatment
measure: modified Rankin Scale (mRS)
timeFrame: 36 months after treatment
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Vivantes - Klinikum Neukölln Institut für klinische und interventionelle Neuroradiologie
city: Hamburg
country: Germany
facility: Klinik und Poliklinik für Neuroradiologische Diagnostik und Intervention, Universitätsklinikum Hamburg-Eppendorf
city: Meppen
country: Germany
facility: Krankenhaus Ludmillenstift, Abteilung für Radiologie, Neuroradiologie und Nuklearmedizin
city: Recklinghausen
country: Germany
facility: KLINIKUM VEST GMBH Knappschaftskrankenhaus Klinik für Radiologie und Neuroradiologie
Study officials:
affiliation: Universitätsklinikum Hamburg-Eppendorf
name: Maxim Bester, PD. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06652282: Pilates Exercise Versus Proprioceptive Neuromuscular Facilitation in Shoulder Dysfunction Post Mastectomy
Official title: Effect of Pilates Exercise Versus Proprioceptive Neuromuscular Facilitation in Shoulder Dysfunction Post Mastectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pilates
Proprioceptive Neuromuscular Fascilitation
Shoulder Dysfunction
Mastectomy
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-10-22
Enrollment: 60
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study was done to evaluate the therapeutic efficacy of Pilates versus PNF in treatment of shoulder dysfunction and limitation of range of motion after mastectomy

Detailed description: Mastectomy is the removal of the entire breast, with five types: simple or total mastectomy, modified radical mastectomy, radical mastectomy, partial mastectomy, and subcutaneous (nipple-sparing) mastectomy. Post-surgical pain and changes in breast shape can lead to side effects like wound infection, hematoma, seroma, shoulder pain, edema, and decreased range of motion. Mastectomy rates vary worldwide, with the highest rate in central and eastern Europe at 77%. Some women at high risk of breast cancer choose to have a mastectomy even when there's no sign of cancer.

Pilates improve flexibility, build strength, and develop control and endurance in the entire body. It emphasizes alignment, breathing, developing a strong core, and improving coordination and balance. The core, consisting of muscles of the abdomen, low back, and hips, is often called the "powerhouse" and is thought to be the key to a person's stability.

Proprioceptive Neuromuscular Facilitation (PNF) is a stretching technique used to improve muscle elasticity and has been shown to have a positive effect on active and passive range of motions.

Eligibility criteria: Inclusion Criteria:

Age range between 40-75 years.

* Only females will participate in the study.
* All patients have no diabetes or blood problems.
* All patients enrolled to the study will have their informed consent

Exclusion Criteria:

Age less than 40 or more than 75 years.

* Diabetes mellitus.
* Subjects suffering from active malignant tumors.
* Subjects treated with skin graft.
* Subjects with Mental illness.
* Subjects with skin diseases
* Subjects with any previous cause for shoulder dysfunction

Primary outcomes:
measure: assessment of the change of shoulder range of motion using Software/Smartphone-based Goniometer
timeFrame: at baseline and 3 months
Secondary outcomes:
measure: Composite assessment of pain and disability using Shoulder pain and disability index
timeFrame: at baseline and 3 months
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: out-patient clinic, faculty of physical therapy, Cairo university
Study officials:
References:
Clinical trial NCT01155882: Registry Study - Whipple at the Splenic Artery
Official title: Whipple at the Splenic Artery - A Procedure for Ductal Adenocarcinoma of the Pancreas With Extensive Involvement of the Porto-Mesenteric Axis: A Registry Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreas Cancer
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2010-07-02
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be identified from PI's patient population or referrals from colleagues.

Brief summary: The purpose of this study is to determine how effective Whipple at the Splenic Artery (WATSA).

Detailed description: Primary

The primary objective of this registry study is to collect clinical data from patients who undergo the WATSA procedure. Specific hypotheses to be tested are

* To determine how effective Whipple at the Splenic Artery (WATSA) is at resecting tumors with negative microscopic margins (R0) at the resection line on the pancreas and at the tangential posterior, uncinate, and venous margins.
* To determine if WATSA can be performed within the usual range of morbidity and mortality (30 day postoperative mortality) for a standard a Whipple procedure.

Secondary

The secondary objectives of this registry study are to

* To determine the survival/recurrence rates at 2 years.
* To determine the effect of occlusion of the splenic vein at the confluence.

Eligibility criteria: Eligibility Criteria - Prospective Portion:

* Patient must have diagnosis of ductal adenocarcinoma of head and/or neck of pancreas, ampullary adenocarcinoma, or pancreatic neuroendocrine tumor confirmed by tissue diagnosis.
* Patient must be between 18 to 85 years of age.
* Patient must be a candidate for the WATSA procedure or have had the WATSA surgery performed within 1 year.
* Patient must be able to understand and willing to sign a written informed consent document.

Eligibility Criteria - Retrospective Portion:

Patient underwent WATSA procedure at our institution between 01/01/2009 and 12/31/2011.

Primary outcomes:
measure: Effectivity of the Whipple at the Splenic Artery
timeFrame: By CT scan at 8 weeks post surgery
measure: To determine range of morbidity and mortality
timeFrame: 30 day postoperative mortality
Secondary outcomes:
measure: Survival/recurrence at 2 years
timeFrame: 2 years
measure: Effect of occlusion of the splenic vein at the confluence.
timeFrame: By CT scan at 8 weeks
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Steven Strasberg, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00960882: Gastric Tolerability and Pharmacokinetics of DMMET-01
Official title: Gastric Tolerability and Pharmacokinetics of DMMET-01. Daily Intake for 30 Days, in Normal Alimentation Conditions, in Healthy Volunteers.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Pharmacokinetics
Diabetes
gastric tolerability
Lead sponsor: Laboratorios Silanes S.A. de C.V.
Sponsor class: INDUSTRY
First posted: 2009-08-18
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the gastric tolerability and the pharmacokinetics of a new drug for the treatment of type 2 diabetes, DMMET-01, in healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* Mexican healthy subjects with normal clinical laboratory test results and imaging (hematology, blood chemistry, urine test, VDRL, Hepatitis B, HIV, chest radiography and electrocardiogram)

Exclusion Criteria:

* Familiar or personal history of diabetes
* History of drug or alcohol abuse within the 2 years prior to the study
* A smoking habit greater tha 10 cigarettes per day
* Intercurrent disease
* Intercurrent treatment with any drug

Primary outcomes:
measure: DMMET-01 Plasmatic concentration
timeFrame: 48 hrs (7.5; 15; 30; 45; 60; 75; 90; 120; 150; 180; 205; 240; 360; 480; 600; 720; 1440 and 2880 min)
Secondary outcomes:
measure: Lanza score
timeFrame: 30 days (0 and 30)
measure: plasmatic glucose
timeFrame: 24 hours (6,12,18 and 24)
measure: glycated hemoglobin
timeFrame: 24 hours (0 and 24)
Other outcomes:
Locations:
city: Monterrey
country: Mexico
facility: Pharmacology and toxicology department, UANL
state: Nuevo León
Study officials:
affiliation: UANL, Pharmacology and toxicology department
name: Oscar Torres, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Laboratorios Silanes S.A. de C.V.
name: Jorge A Gonzalez, Master
role: STUDY_DIRECTOR
References:
Clinical trial NCT04672382: Evaluation of Peripheral Itch Mechanisms Following Injection of Morphine
Official title: Effect of Intradermal Morphine Application on Histaminergic and Non-histaminergic Itch and Related TRPV1 and Antihistamine Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Morphine
Histamine
Cowhage
Isotonic Saline
Lead sponsor: Aalborg University
Sponsor class: OTHER
First posted: 2020-12-17
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this study is to the effect of opioid (morphine) intradermal application on histaminergic and non-histaminergic itch. In particular, we would like to demonstrate that also peripheral administration of morphine may affect mast cell release of histamine.

Detailed description: Opioids (i.e. substances extracted from opium poppies, e.g. morphine) are used for treatment of both acute and chronic pain conditions as well as in surgical procedures. Opioids render effective pain relief, however, they may cause bothersome itch as a side effect. With this series of experiments, we wish to clarify how an injection with morphine in the skin layer called dermis (located right below the upper skin) will affect itch.

Eligibility criteria: Inclusion Criteria:

* Healthy men and women
* 18-60 years
* Speak and understand English

Exclusion Criteria:

* Participants with any clinically significant abnormalities that in the opinion of the investigator may increase the risk associated with trial participation or may interfere with the interpretation of the trial results.
* Pregnancy or lactation
* Drug addiction defined as any use of cannabis, opioids or other addictive drugs
* Lack of ability to cooperate
* Current use of medications that may affect the trial such as antihistamines, antipsychotics and pain killers as well as systemic or topical steroids.
* Participants with known allergy/discomfort to the opioid morphine and antihistamine.
* Skin diseases
* Moles, scars or tattoos in the area to be treated or tested.
* Consumption of alcohol or painkillers 24 hours before the study days and between these
* Acute or chronic pain
* Participation in other trials within 1 week of study entry (4 weeks in the case of pharmaceutical trials)

Primary outcomes:
measure: Measuring itch by computerized Visual Analog Scale Scoring
timeFrame: 10 minutes
measure: Measuring pain by computerized Visual Analog Scale Scoring
timeFrame: 10 minutes
measure: Superficial blood perfusion measurement
timeFrame: 15 minutes
Secondary outcomes:
measure: While size
timeFrame: 15 minutes
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Silvia Lo Vecchio
state: Nordjylland
Study officials:
References:
Clinical trial NCT01077882: Analysis of the Quality of Life, the Clinical Effectiveness and Cost-effectiveness of a Novel Educational Programme in Patients With Psoriasis and Atopic Dermatitis
Official title: Analysis of the Quality of Life, the Clinical Effectiveness and Cost-effectiveness of a Novel Educational Programme in Patients With Psoriasis and Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Psoriasis
Atopic Dermatitis
Keywords: Moderate and severe psoriasis and atopic dermatitis
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2010-03-01
Enrollment: 50
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: SUPPORTIVE_CARE

Brief summary: 'OnderHUIDs' is an educational program (Department of Dermatology, University Hospital, Gent) for patients with psoriasis and atopic dermatitis. We want to stimulate the patient to actively participate in their therapeutic approach by enhanced self care. We call the hypothesis that this program will help the patients learn to cope with their disease and to be loyal to their treatment, which will result in a better quality of life, better clinical outcome and cost effectiveness.


Eligibility criteria: Inclusion Criteria:

* Patients who have given written informed consent
* Women or men of any race
* Patients who are 18-75 years of age
* Diagnosis of psoriasis or atopic dermatitis

Exclusion Criteria:

* Patients with a cognitive disorder (not able to understand, speak, read or write..)
* Patients with a significant underlying medical cause (i.e. severe infection, haematologic disease, malignity, severe renal or hepatic disease, major depression) in the last 3 months
* Patients under experimental pharmaceutical medication

Primary outcomes:
measure: Effectiveness of a novel educational program on the quality of life and the clinical outcome.
timeFrame: At 12 weeks, after 6 and 9 months
Secondary outcomes:
measure: Depression severity
timeFrame: At 12 weeks, 6 months and 9 months
measure: Lifestyle
timeFrame: At 12 weeks, 6 months and 9 months
measure: Medical consumption and cost-effectiveness evaluation
timeFrame: At 12 weeks, 6 months and 9 months
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Jo Lambert, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02424682: Safety of Herceptin/Trastuzumab in Metastatic Breast Cancer
Official title: Safety of Herceptin in Metastatic Breast Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer, Metastatic Breast Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2015-04-23
Enrollment: 69
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with human epidermal growth factor receptor (HER) 2 positive metastatic breast cancer

Brief summary: This study was designed to evaluate safety and tolerability of Herceptin as treatment for patients with human epidermal growth factor receptor 2 (HER-2) positive metastatic breast cancer. Frequency, characteristics and severity of adverse events (AE) and serious adverse events (SAE) were followed to evaluate the safety of Herceptin in patients with HER2 positive metastatic breast cancer.


Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of metastatic breast cancer (BC) with HER2-neu overexpression
* Left Ventricular Ejection Fraction (LVEF) by ECHO or Multi Gated Acquisition Scan (MUGA) \> 50%
* Good performance status: Eastern Cooperative Oncology Group (ECOG) scale \< or = 2 and life expectancy \> or = 12 weeks

Exclusion Criteria:

* Advanced pulmonary disease and severe dyspnea
* Abnormal laboratory within 14 days prior to registration
* Peripheral neuropathy \> grade 2
* Presence of central nervous system (CNS) metastasis
* Pregnancy or lactating

Primary outcomes:
measure: Percentage of Participants with Adverse Events (AEs)
timeFrame: Up to 2 years
measure: Percentage of Participants with Serious Adverse Events (SAEs)
timeFrame: Up to 2 years
measure: Percentage of Deaths
timeFrame: Up to 2 years
Secondary outcomes:
measure: Percentage of Participants with Serious Adverse Events (SAEs), Who Experienced Progression of Disease
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Sremska Kamenica
country: Serbia
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT01375582: Objective Evaluation of Ocular Surface Lubricants in Two Environments
Official title: Objective Evaluation of Ocular Surface Lubricants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Dry Eye
Keywords: Dry Eye
tear film
lipid
tear volume
environmental chamber
thermal imaging
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: Bausch & Lomb Incorporated
First posted: 2011-06-17
Enrollment: 20
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will evaluate ocular surface lubricants in subjects with dry eye syndrome.

Detailed description: This study will objectively evaluate ocular surface lubricants in subjects with dry eye syndrome. Lubricants contain compounds that are purported to improve dry eye symptoms, although objective data is not available. The investigators seek to objectively evaluate the effectiveness of two lubricants and compare the results to a saline eye drop (control).

The investigators will assess the lipid layer before and after the administration of three products in the same eye of 25 dry eye subjects using the ellipsometry, imaging in a "normal" environment. Subsequently the investigators will change the environment to one that causes the subjects' ocular surface to experience "evaporative stress" (warmer, less humid and greater air flow) and perform the before and after drop administration measurements with the same three products in the same eye as the first environment.

Eligibility criteria: Inclusion Criteria:

* Age 30-75 years
* Good general health
* Willing to spend time for the study; approximately one hour for a screening visit and 90 minutes for each of the measurement visits
* Currently using an OTC artificial tear for ocular comfort, at least occasionally.
* At least one positive dry eye symptom.

Exclusion Criteria:

* Current eye disease, infection or inflammation that requires the use of any prescription ocular medication.
* Recent past eye surgery.
* Female subjects may not be pregnant or lactating.
* Infectious diseases

Primary outcomes:
measure: Tear Film Properties
timeFrame: Measurements: There is no time restriction between the screening and 1st measurement. 6 measurement visits occur approximately 7 days apart but can range from 3 to 14 days. The time between visit 3 and 4 are not be closer than 3 days, but no upper limit.
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Flaum Eye Institute at the University of Rochester
state: New York
Study officials:
affiliation: University of Rochester
name: James V Aquavella, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06215482: The Effect of "Adjacent Bed Effect" Induced by Anxiety on the Perioperative Period of Patients With Chocolate Cyst of Ovary
Official title: The Effect of "Adjacent Bed Effect" Induced by Anxiety on the Perioperative Period of Patients With Chocolate Cyst of Ovary
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Participants' Pain,Quality of Life and Hospital Satisfaction
Lead sponsor: Second Affiliated Hospital of Wenzhou Medical University
Sponsor class: OTHER
First posted: 2024-01-22
Enrollment: 42
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: Anxious or nonanxious state in participants with chocolate cysts

Brief summary: The "adjacent bed effect" caused by anxiety leads to poor recovery of participants after ovarian chocolate cyst surgery, including pain and quality of life, and affects participant satisfaction with the hospital.


Eligibility criteria: Inclusion Criteria:

1. Ovarian chocolate cyst diameter ≥4cm;
2. Infertility;
3. Dysmenorrhea medications were ineffective; Any one of the above, with or without clinical symptoms.

Exclusion Criteria:

1. Age \<18 years old;
2. Previous history of other surgeries;
3. Previous history of nervous system diseases, such as Parkinson's disease, dementia, etc.
4. Previous history of blood system diseases, such as leukemia;
5. Unable to tolerate surgery due to serious complications, such as serious cardiovascular and cerebrovascular diseases;
6. Inability to complete the questionnaire due to language or learning disabilities;
7. Those who don't want to participate.

Primary outcomes:
measure: participant demographic information
timeFrame: through study completion, an average of 2 month
Secondary outcomes:
measure: Postoperative Scale scores
timeFrame: through study completion, an average of 2 month
measure: scale were completed after operation
timeFrame: through study completion, an average of 2 month
measure: scale were completed after operation
timeFrame: through study completion, an average of 2 month
measure: scale were completed after operation
timeFrame: through study completion, an average of 2 month
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: Qiong Zhang
Study officials:
affiliation: Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
name: Qiong joan_zhang2002@sina.com
role: STUDY_CHAIR
References: