louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01047579: A 12 Week, Multicenter, Open Label Evaluation of Caregiver Preference, Safety and Tolerability of Exelon® Patch (Rivastigmine Transdermal) in Patients With Alzheimer's Disease
Official title: A 12 Week, Multicenter, Open Label Evaluation of Caregiver Preference, Safety and Tolerability of Exelon® Patch (Rivastigmine Transdermal) in Patients With Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Alzheimer's Disease
Keywords: Alzheimer's Disease
Rivastigmine transdermal
caregiver preference
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2010-01-13
Enrollment: 51
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study is designed to evaluate caregiver preference for Exelon® patch (target patch size 10 cm²) treatment in patients with Alzheimer's disease (MMSE 10-26) who were under cholinesterase inhibitor treatment and experienced adverse event/s in a community setting.


Eligibility criteria: Inclusion Criteria:

* Probable Alzheimer's disease according to the NINCDS-ADRDA and DSM-IV criteria.
* MMSE score of \>10 and \<26.
* Patients who were under ChE inhibitor treatment and experienced adverse events.
* Residing with someone in the communities throughout the study or if, living alone, in contact with the responsible caregiver every day, primary caregiver willing to accept responsibility for supervising the treatment and condition of the patient.

Exclusion Criteria:

* Involved in other clinical trials or treated by experimental drug within the previous 4 weeks.
* Current diagnosis of an active skin lesion that would prevent accurate assessment of the adhesion and potential skin irritation of the patch.
* History of allergy to topical products containing any of the constitution of the patches.
* Patients with evidence of severe or unstable physical illness, i.e., acute and severe asthmatic conditions, severe or unstable cardiovascular disorders, etc.
* Patients with bradycardia (bpm less than 50) or sick sinus syndrome or conduction defects (sino-atrial block, second degree A-V blocks).
* Patients with body weight less than 40 kg.

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Caregiver questionnaire
timeFrame: 12 weeks
Secondary outcomes:
measure: Safety and Tolerability. Safety assessments include vital signs and adverse events (AEs)
timeFrame: every visit
Other outcomes:
Locations:
city: Ashkelon
country: Israel
facility: Novartis Investigative Site
city: Haifa
country: Israel
facility: Novartis Investigational Site
city: Holon
country: Israel
facility: Novartis Investigative Site
city: Ramat Gan
country: Israel
facility: Novartis Investigative Site
city: Tel Aviv
country: Israel
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT05446779: Postmortem Evaluation of Adrenal and Other Endocrine Tumors in Patients With Sudden Death
Official title: Postmortem Evaluation of Adrenal and Other Endocrine Tumors in Patients With Sudden Death Without Definitive Causative Diagnosis (PEA-SuddenDeath)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Primary Aldosteronism
Adrenal Cushing Syndrome
Pheochromocytoma
Endocrine Neoplasia
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
Collaborators: name: Finnish Institute for Health and Welfare
name: University of Helsinki
name: Tampere University Hospital
name: Tampere University
First posted: 2022-07-07
Enrollment: 400
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: We enroll aproximately 200 consecutive patients with out-of-hospital, sudden death to both groups.

Brief summary: Sudden Cardiac Death is a leading cause of mortality and remains a major public health burden worldwide. Cardiac arrest due to coronary heart disease explains a large proportion of the cases, but if autopsy is not performed the exact underlying cause remains obscure in many adults who face sudden death outside heath care organizations. The investigators aim to find proof that primary aldosteronism is a risk factor for sudden death and to characterize the prevalence of adrenal pathology in sudden death of undetermined cause in a case-control study. In addition, the study aims to characterize the prevalence of other adrenal pathology i.e. silent adenomas, cortisol-producing adenomas and pheochromocytomas in sudden death. The investigators also seek evidence that other endocrine hormone overproduction-causing diseases are more prevalent in persons with sudden death compared with those experiencing traumatic or suicidal death sudden death.


Eligibility criteria: Inclusion Criteria:

Consecutive patients with out-of-hospital, sudden death

Exclusion Criteria:

1. Estimated time from death to refrigerator more than 24-48 hours and in the refrigerator time more than 7 days (susceptibility to excessive tissue breakdown)
2. Terminal disease
3. Institutionalized patients

Primary outcomes:
measure: CYP11B2 staining in adrenal glands
timeFrame: Through study completion, an average of 2 years
measure: CYP11B1 staining in adrenal glands
timeFrame: Through study completion, an average of 2 years
Secondary outcomes:
measure: CYP11B2 staining in adrenal glands
timeFrame: Through study completion, an average of 2 years
measure: Pheochromocytoma or paraganglioma
timeFrame: Through study completion, an average of 2 years
measure: Neuroendocrine tumor
timeFrame: Through study completion, an average of 2 years
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Endocrinology, Helsinki University Hospital and University of Helsinki
Study officials:
affiliation: Helsinki University Central Hospital
name: Niina Matikainen, MD, PhD, Assoc Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05812079: Insulin Like Growth Factor-1 Against Oxidative Stress in Vitiligo
Official title: Assessing the Protective Role of Insulin Like Growth Factor 1 Against Oxidative Stress in Vitiligo Patients
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Vitiligo
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-04-13
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Non-Segmental Vitiligo

Brief summary: Insulin like growth factor has a protective role on melanocytes against the oxidative stress. The aim is to investigate this effect in vitiligo patients.


Eligibility criteria: Inclusion Criteria:

* Non-segmental vitiligo

Exclusion Criteria:

1. Pregnant or lactating females
2. Smokers
3. Patients with any endocrinal disease known to affect GH or IGF-1 as Diabetes (by measuring HbA1c) and Thyroid disturbance (by measuring TSH)
4. Patients with liver disease (by measuring AST, ALT and GGT)
5. Obese patients (by measuring BMI)
6. Patients with history of ischemic heart disease (known medical history of angina or myocardial infarction or history of recurrent chest pain, left shoulder pain, shortness of breath or fatigue on the ordinary effort or less than the ordinary effort )
7. Patients with history of Peripheral arterial disease (Known medical history of peripheral arterial thrombosis or history of recurrent claudications)
8. Patients with history of cerebero-vascular disease (known medical history of transient ischemic attacks or stroke)
9. Patients who received systemic treatment for vitiligo during the previous six months or topical treatment during the previous two months

Primary outcomes:
measure: Investigate for IGF-1 and IMA levels in vitiligo
timeFrame: one year
Secondary outcomes:
measure: Measure IMA in vitiligo and correlate it with psychological status of patients
timeFrame: One year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03826979: PILATES METHOD ON THE UPPER LIMBS FUNCTIONALITY
Official title: PILATES METHOD ON THE UPPER LIMBS FUNCTIONALITY OF THE MASTECTOMIZED WOMEN
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Neoplasm Female
Keywords: Breast cancer.
Exercise Therapy
Modified Radical Mastectomy
Lead sponsor: Universidade Metodista de Piracicaba
Sponsor class: OTHER
First posted: 2019-02-01
Enrollment: 22
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The participants undergo to a physical therapy rehabilitation program through the Pilates Method for 2 months
Primary purpose: TREATMENT

Brief summary: INTRODUCTION: Breast cancer is one of the pathologies affecting women worldwide, with a high mortality rate of 14,206 per 100,000 women per year. However, Pilates was used as a therapeutic treatment for women who underwent a modified radical mastectomy, being associated with the alterations when in the postoperative sequels.

OBJECTIVE: to evaluate the Pilates Method in the functionality of women submitted to modified radical mastectomy.

METHOD: This is a quantitative clinical trial, in the form of women included in the project, to undergo a physical therapy rehabilitation program through the Pilates Method for 2 months, where they were evaluated before and after the procedure for measurement and comparison obtained.

CONCLUSION: In this way, the pilates method is presented as an instrument used for the rehabilitation of mastectomized women.


Eligibility criteria: Inclusion Criteria:

* Female subjects, between 30 and 65 years, with a diagnosis of breast cancer, who underwent radical-mastectomy surgery and who had after 30 postoperative days

Exclusion Criteria:

* Women who present alterations in healing, severe pain, who have another type of treatment, people who lack more than three times in the research, quitters, people with relapses and who do not tolerate the treatment protocol.

Primary outcomes:
measure: Muscle strength
timeFrame: 2 months
measure: Range of motion
timeFrame: 2 months
measure: Functionality assess with Functional independence measure scale
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Belém
country: Brazil
facility: Raphael Pereira
state: PA
Study officials:
References:
Clinical trial NCT06241079: Multi-institutional Analysis of Survival and Recurrence Patterns of Different Pathological Regression Types After Neoadjuvant Chemoradiotherapy or Radiotherapy for Esophageal Squamous Cell Carcinoma
Official title: Multi-institutional Analysis of Survival and Recurrence Patterns of Different Pathological Regression Types After Neoadjuvant Chemoradiotherapy or Radiotherapy for Esophageal Squamous Cell Carcinoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Esophageal Squamous Cell Carcinoma
Lead sponsor: Tianjin Medical University Cancer Institute and Hospital
Sponsor class: OTHER
Collaborators: name: Chinese Academy of Medical Sciences
name: Sichuan Cancer Hospital and Research Institute
First posted: 2024-02-05
Enrollment: 582
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with esophageal squamous cell carcinoma (ESCC) who received NCRT or neoadjuvant radiotherapy (NRT) followed by esophagectomy from 2003 to 2022

Brief summary: The goal of this multicenter retrospective cohort study is to evaluate the impact of different pathological regression types on survival and recurrence patterns, with a particular focus on ypT0N+ patients in patients with esophageal squamous cell carcinoma. The main questions it aims to answer are the survival and recurrence patterns among the different pathological regression types in patients with esophageal squamous cell carcinoma after neoadjuvant chemoradiotherapy.


Eligibility criteria: Inclusion Criteria:

* histologically confirmed potentially resectable ESCC, clinical stage T1-4N0-1M0 (stage I-III) according to the American Joint Committee on Cancer 6th edition staging criteria.

Exclusion Criteria:

* incomplete surgical resection, two-dimensional radiotherapy, and incomplete clinical data.

Primary outcomes:
measure: Overall survival
timeFrame: From date of surgery until the date of death from any cause or last follow-up, assessed up to 10 years.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02712879: Moderate Bleeding in Cardiac Surgery Post Operative
Official title: Bleeding Moderate Postoperative Cardiac Surgery and Prognostic Implications Anemia and Postoperative Transfusion: Prospective, Observational, Descriptive.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Surgery
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2016-03-18
Enrollment: 303
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients admitted to intensive care after surgery for heart surgery

Brief summary: Determine a bleeding threshold by measuring the blood volume in ml / kg / h collected in the drainage system to define moderate bleeding postoperative cardiac surgery and define the population.

Detailed description: Determine a bleeding threshold by measuring the blood volume in ml / kg / h collected in the drainage system to define moderate bleeding postoperative cardiac surgery and define the population.

Secondary objectives:

To evaluate the kinetics of moderate SPORT and its impact on anemia and postoperative transfusion.

To evaluate the prognostic impact of the SPO moderate in terms of post-operative complications.

Determine predictors of moderate SPO.

Eligibility criteria: Inclusion Criteria:

* Patients in the postoperative intensive care in cardiac surgery

Exclusion Criteria:

* Patients who received a heart transplant, a heart surgery beating, cardiac support establishment of long duration, or have a disease that alters the coagulation.

Primary outcomes:
measure: Evolution of blood loss per hour drains
timeFrame: Hourly blood loss in drains during the first twelve hours
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: UHMontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Marine SAOUR, CCA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00905879: Observational Study on the Safety and Tolerability of Gadobutrol (Gadovist) Among Filipino Patients in Magnetic Resonance Imaging
Official title: Observational Study on the Safety and Tolerability of Gadobutrol (Gadovist) Among Filipino Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Magnetic Resonance Imaging
Keywords: Magnetic Resonance Imaging (MRI)
Observational study
Gadobutrol
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2009-05-21
Enrollment: 30
Sex: ALL
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: Patients 18 years old and above who will undergo contrast enhanced MRI with Gadobutrol (Gadovist)

Brief summary: Patients will be recruited from those who will undergo contrast enhanced MRI. Safety and tolerability will be assessed.


Eligibility criteria: Inclusion Criteria:

* 18 years old and above undergoing contrast enhanced cranial or spinal MRI with Gadobutrol (Gadovist)

Exclusion Criteria:

* History of hypersensitivity reaction to gadolinium containing contrast material
* Hypersensitivity to any of the ingredients of Gadobutrol (Gadovist)
* History of hypersensitivity to any other contrast agent
* Patients with uncorrected hypokalemia
* Pregnant and lactating women
* Patients with severe cardiovascular diseases
* Patients in whom MRI cannot be performed.

Primary outcomes:
measure: The primary outcome measures would be safety and tolerability of Gadovist which would be measured by change in Vital signs before and after the procedure and the occurrence of serious or non-serious adverse events
timeFrame: Up to 1 hour after MRI
Secondary outcomes:
Other outcomes:
measure: Magnetic field strength of MRI
timeFrame: During the procedure
measure: Volume of contrast agent used
timeFrame: During the procedure
Locations:
city: Many Locations
country: Philippines
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01085279: Fractional Laser as Treatment Option for Various Pigment Disorders (Fractional-3)
Official title: Non-ablative 1,550 nm Fractional Laser Therapy Versus Triple Topical Therapy for the Treatment of Melasma: a Randomized Controlled Split-face Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pigmentation Disorder
Keywords: fractional laser
melasma
topical bleaching
Lead sponsor: Netherlands Institute for Pigment Disorders
Sponsor class: OTHER
First posted: 2010-03-11
Enrollment: 29
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 determine whether the use of non-ablative fractional laser is safe and effective in the treatment of melasma.


Eligibility criteria: Inclusion Criteria:

* Melasma
* Subjects attending the outpatient department of the Netherlands Institute for Pigment Disorders
* Age at least 18 years
* Subject is willing and able to give written informed consent

Exclusion Criteria:

* use of bleaching creams during the past six weeks
* history of keloid
* active eczema
* suspected hypersensitivity to lidocaine or triple therapy
* use of isotretinoin in the past six months
* high exposure of the lesion to sunlight or UV light (UVA or UVB).

Primary outcomes:
measure: Physician's global assessment
timeFrame: T0, 3 weeks, and 3 and 6 months follow-up
Secondary outcomes:
measure: L-value
timeFrame: T0, 3 weeks and 3 and 6 months follow-up
measure: Melanin index
timeFrame: T0, 3 weeks and 3, and 6 months follow-up
measure: Patient's global assessment
timeFrame: 3 weeks, 3 and 6 months follow-up
measure: Patient's satisfaction
timeFrame: 3 weeks, 3 and 6 months follow-up
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Netherlands Institute for Pigment disorders
Study officials:
affiliation: Netherlands Institute for Pigment Disorders
name: Albert Wolkerstorfer, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02235779: Diagnostic Yield of Transbronchial Cryobiopsy in Diagnosis of Interstitial Lung Diseases
Official title: DIagnostic Yield of Transbronchial Cryobiopsies in Subjects With Interstitial Lung Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Interstitial Lung Disease
Keywords: ILD
Pulmonary fibrosis
Cryobiopsy
Transbronchial
Lead sponsor: Laval University
Sponsor class: OTHER
First posted: 2014-09-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Evaluation of diagnostic yield, feasibility and safety of transbronchial lung cryobiopsies done via bronchoscopy in the investigation of interstitial lung disease in comparison with videothoracoscopy-assisted surgical lung biopsy.

Detailed description: See above

Eligibility criteria: Inclusion Criteria:

* Volunteer subjects with interstitial lung disease in whom a surgical lung biopsy is planned for diagnostic investigation.

Exclusion Criteria:

* Aged less than 18 y.o.
* Pregnancy
* Known coagulatoin disorder or blood dyscrasia
* Aaking antiplatelet agents other than aspirin or therapeutic anticoagulants drugs that cannot be safely discontinued to undergo lung biopsy
* Arterial oxgen pressure less than 60 mmHg on more than 2 liters per minute oxygen
* Known pulmonary hypertension defined as systolic PAP above 40 mmHg on echocardiography
* Unable to provide informed consent

Primary outcomes:
measure: Overall diagnostic yield of cryobiopsy specimens in interstitial lung disease
timeFrame: After biopsy (up to 24 months)
Secondary outcomes:
measure: Complication rate of transbronchial cryobiopsy procedure
timeFrame: Per-procedure and up to 24 hours after
measure: Number of diagnostic specimens of cryoTBB in comparison with surgical lung biopsy specimen
timeFrame: After biopsy (up to 24 months)
measure: Inter-observer agreement for cryobiopsy specimens
timeFrame: After biopsy (up to 24 months)
measure: Size of cryobiopsy specimen
timeFrame: After biopsy (up to 24months)
measure: Quality of cyrobiopsy specimens
timeFrame: After biopsy (up to 24 months)
Other outcomes:
Locations:
city: Québec
country: Canada
facility: Institut universitaire de cardiologie et de pneumologie de Québec
Study officials:
affiliation: Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
name: Antoine Delage, MDCM
role: STUDY_CHAIR
References:
Clinical trial NCT02491879: Ketoprofen Gel vs Placebo in Low Back Pain
Official title: Ketoprofen Gel vs Placebo in Patients Presented With Low-back Pain to Emergency Department: A Ranodmized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Mechanical Low Back Pain
Keywords: mechanical low back pain
emergency department
ketoprofen
gel
Lead sponsor: Akdeniz University
Sponsor class: OTHER
Collaborators: name: Kocatepe University
name: Celal Bayar University
First posted: 2015-07-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aimed to analyse the analgesic effect of ketoprofen gel in patients presented with mechanical low-back pain to the emergency department.

Detailed description: Mechanical low-back pain which warrants immediate pain relief is not an infrequent symptom for emergency department physicians to deal with. Parenteral analgesic is the most common drugs for the these patients in emergency department. However, pain killers in gel forms have not been studied sufficiently for ceasing the pain of these patients. This study aimed to analyse the analgesic effect of ketoprofen gel in patients presented with mechanical low-back pain to the emergency department.

Eligibility criteria: Inclusion Criteria:

* Patients over 18 and lower 65 years old
* Patients presented with mechanical low-back pain

Exclusion Criteria:

* Pain more than 24 hours
* Pain lower than with a pain score of 40 mm
* Allergy to ketoprofen
* Drug or alcohol addiction
* pregnancy and breast feeding

Primary outcomes:
measure: Visual Analogue Scale
timeFrame: 30 minutes
Secondary outcomes:
measure: Adverse outcome
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Denizli
country: Turkey
facility: Pamukkale University
Study officials:
affiliation: Pamukkale University
name: Mustafa Serinken, MD
role: STUDY_CHAIR
References: