louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00229450: Estrogen and Perimenopausal Depression
Official title: Dose Response Effects of Estrogen Augmentation in Mood & Memory in Perimenopausal Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Depressive Disorder, Major
Menopause
Keywords: depression
menopause
perimenopause
mood
memory
perimenopausal
antidepressant
estrogen
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: National Alliance for Research on Schizophrenia and Depression
First posted: 2005-09-29
Enrollment: 17
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: During perimenopause (the time just prior to menopause), women often notice many biological, psychological, and social changes. In particular, some women experience depressive symptoms during perimenopause that are severe enough to warrant antidepressant medication. Whether or not women with perimenopausal depression respond to antidepressant medication may depend on the level of estrogen in their blood. This study will investigate whether estrogen will help women who only partially respond to antidepressant medications, as well as examine how different doses of estrogen may affect individuals differently.


Eligibility criteria: Inclusion Criteria:

* Clinical Diagnosis of Unipolar Major Depression, currently taking antidepressants
* HAM-D between 10 and 17

Exclusion Criteria:

* History of Psychosis, breast cancer, smoking, dementia, clotting disorders
* Current substance abuse

Primary outcomes:
measure: Mood
timeFrame: 6 weeks
Secondary outcomes:
measure: Memory
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Neuropsychiatric Institute & Hospital
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Melinda L. Morgan, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Morgan ML, Cook IA, Rapkin AJ, Leuchter AF. Estrogen augmentation of antidepressants in perimenopausal depression: a pilot study. J Clin Psychiatry. 2005 Jun;66(6):774-80. doi: 10.4088/jcp.v66n0617.
citation: Cook IA, Morgan ML, Dunkin JJ, David S, Witte E, Lufkin R, Abrams M, Rosenberg S, Leuchter AF. Estrogen replacement therapy is associated with less progression of subclinical structural brain disease in normal elderly women: a pilot study. Int J Geriatr Psychiatry. 2002 Jul;17(7):610-8. doi: 10.1002/gps.644.
Clinical trial NCT01853150: Repetitive Transcranial Magnetic Stimulation for Freezing of Gait
Official title: Repetitive Transcranial Magnetic Stimulation for Freezing of Gait
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinsonian Disorders
Lead sponsor: Dongtan Sacred Heart Hospital
Sponsor class: OTHER
First posted: 2013-05-14
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Freezing of gait (FOG) means that patients cannot walk without any known causes, other than parkinsonism, which is very disabling symptom. Patients descirbe their feeling of the feet suddenly being glued to the floor. Transcranial magnetic stiumation is a noninvasive procedure using electromagnetic induction to stimulate brain. Transcranial magnetic stiumation (rTMS) can selectively change brain activity to enhance desired effects. The aim of this study is to the therapeutic effect of rTMS for the FOG.


Eligibility criteria: Inclusion Criteria:

* Parkinson's disease or Primary progressive freezing of gait
* age 18 and older
* Freezing of gait

Exclusion Criteria:

* pregnant or any, other medical, surgical, neurological or psychiatric conditions
* other restrictions which prevent you from undergoing TMS recording, such as; surgically or traumatically implanted foreign bodies such as a pacemaker, an implanted medication pump, a metal plate in the skull, or metal inside the skull or eyes (other than dental appliances or fillings), and/ or heart/cardiac lines
* any past or current history of seizure disorder or epilepsy
* unable to give informed consent

Primary outcomes:
measure: The number of steps
timeFrame: 2 days
Secondary outcomes:
measure: The completion time during the SWS test
timeFrame: 2 days
measure: Freezing episodes of gait trajectory
timeFrame: 2 days
measure: Patient and Clinical Global Impression Scale
timeFrame: 2 days
Other outcomes:
Locations:
city: Hwaseong Si
country: Korea, Republic of
facility: Dongtan Sacred Heart Hospital
state: Gyeonggi-Do
Study officials:
References:
Clinical trial NCT00212550: Evaluation of the Practice of Three Morning Sputa on Separate Days for Diagnosis of Mtb
Official title: Evaluation of the Practice of Three Morning Sputa on Separate Days for Diagnosis of Mtb
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary TB
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2005-09-21
Enrollment: 10
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: TB patients

Brief summary: Obtain sputum smears within one day to rule out TB


Eligibility criteria: Inclusion Criteria:

* All subjects admitted to Bellevue Hospital for evaluation of possible TB

Exclusion Criteria:

* Unable to produce spontaneous or induced sputum

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU School of Medicine Division of Pulmonary and Critical Care
state: New York
Study officials:
affiliation: NYU School of Medicine
name: Rany Condos, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03677050: Effect of Individualized Patient Education Including Drinking Advice Using an App
Official title: Effect of Individualized Patient Education Including Drinking Advice Using an App
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Keywords: Bowel preparation
Colonoscopy
Smart phone application
Patient satisfaction
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2018-09-19
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized clinical trial
Primary purpose: DIAGNOSTIC

Brief summary: Study evaluating the effect of a personalized smart phone application in addition to standard care on bowel preparation scores, compared to standard care alone.

Detailed description: Picoprep is a low-volume bowel preparation used to optimize visualization of the colonic mucosa during colonoscopy. Patients referred for a colonoscopy will be scheduled for an intake. During this intake patients receive education about Picoprep and will be asked about their health condition (medical history, medication use). Standard a face-to-face education is given by an intake nurse or doctor. The producers of Picoprep, Ferring BV designed an app including a drinking schedule adapted to the timing of the coloscopy, aiming a lag time between intake of the last Picoprep dose and the scopy of 2-4 hours. We hypothesize that the Boston Bowel Preparation Scale and patient satisfaction will be higher in patients receiving standard education plus using the bowel preparation app versus patients receiving single standard education.

Eligibility criteria: Inclusion Criteria:

* Patients refered to our clinic for colonoscopy by general practitioner, colorectal cancer screening programme or outpatient clinic
* Use of regular sodium picosulfate bowel preparation scheme
* Possession of an Android or iOS smart phone

Exclusion Criteria:

* Emergency colonoscopy
* Hospitalized patients

Primary outcomes:
measure: Boston Bowel Preparation Score
timeFrame: During colonoscopy
Secondary outcomes:
measure: Patient satisfaction questionnaire
timeFrame: end of preparation procedure
measure: Caecal intubation rate
timeFrame: during colonoscopy
measure: Adenoma detection rate
timeFrame: during colonoscopy
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
state: Limburg
Study officials:
affiliation: Maastricht University Medical Center
name: A.A.M. Masclee, Prof. MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: van der Zander QEW, Reumkens A, van de Valk B, Winkens B, Masclee AAM, de Ridder RJJ. Effects of a Personalized Smartphone App on Bowel Preparation Quality: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2021 Aug 19;9(8):e26703. doi: 10.2196/26703.
Clinical trial NCT05770050: Cardiac Changes Associated With Acute Cerebro-vascular Stroke
Official title: Cardiac Changes Associated With Acute Cerebrovascular Stroke
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cerebrovascular Accident
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-03-15
Enrollment: 145
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: All patients with acute cerebrovascular accident and have cardiac diseases are investigated by ECG, Echo, Troponin level to detect different cardiac abnormalities associated with cerebrovascular accident

Brief summary: Cardiovascular disease is regarded as main predisposing risk factor for cerebrovascular stroke.

Cardiac dysfunction can both worsen the pre existing cerebral damage and cause new brain injury Diseases of the heart and the brain are closely entangled. Vascular diseases of both organs share the same risk factors.


Eligibility criteria: Inclusion Criteria:

1. above 18 years
2. patients presented with cerebrovascular stroke 3-patients diagnosed as cardiac patients and have cerebrovascular stroke

Exclusion Criteria:

1-Less than 18 years

Primary outcomes:
measure: ECG changes in cerebrovascular accident
timeFrame: 6 months
measure: Echo changes in cerebrovascular accident
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06235450: A Usability Study of iTEAR100 For Combined EyeLid Microblepharoexfoliation and Neurostimulation
Official title: A Usability Study of iTEAR100 For Combined EyeLid Microblepharoexfoliation and Neurostimulation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: MicroBlepharoexfoliation, NuLids, iTEAR100, iLIDS100, Blepharitis, Dry Eye Syndrome
Lead sponsor: Olympic Ophthalmics, Inc.
Sponsor class: INDUSTRY
First posted: 2024-02-01
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open Label, Prospective, Therapeutic Intervention
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the usability of the iTEAR100 generation 2 device in combination with its newly developed iLIDS100 disposable cover.

Detailed description: This usability study is meant to validate treatment using the iLIDS100 in patients who already use the NuLids Device and iTEAR100. The patients will simply substitute the iLIDS100 cover in combination with the iTEAR100 for the NuLids product and otherwise maintain their same treatment regimen. The planned number of subjects was chosen to provide clinically relevant usability data

Eligibility criteria: Inclusion Criteria:

Must use iTEAR and NuLids at time of enrollment

Exclusion Criteria:

1. have any condition, which in the judgment of the PI would prevent a potential subject from safely completing the study or tolerating device use, such as mental illness, dementia, severe agitation, etc. and including inability to comply with the treatment regimen.

Primary outcomes:
measure: Questionnaire
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Issaquah
country: United States
facility: Olympic Ophthalmics
state: Washington
Study officials:
References:
Clinical trial NCT04538950: PET/CT Quantitative Assessment of Myocardial Blood Flow Changes in Oncologic Patients Receiving Checkpoint Inhibitor Therapy
Official title: PET/CT Quantitative Assessment of Myocardial Blood Flow Changes in Oncologic Patients Receiving Checkpoint Inhibitor Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Cancer
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-09-04
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Researchers are trying to determine the side effects on the heart from immune checkpoint inhibitor (ICI) treatment in patients with cancer.


Eligibility criteria: Inclusion Criteria:

* First time administration of ICI
* Willing and able to return in 4-6 weeks for follow-up study
* Patients with previous heart conditions included (while this may impact MFR the delta MFR is what we are assessing)

Exclusion Criteria:

* Age \< 18 years
* Women who are pregnant, or breast-feeding.
* Unable or unwilling to give consent to undergo PET/CT.

Primary outcomes:
measure: Microvascular Damage/Endothelial Dysfunction
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: John Bois, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01108250: LOC387715/HTRA1 Variants in Polypoidal Choroidal Vasculopathy in a Korean Population
Official title: LOC387715/HTRA1 Variants in Polypoidal Choroidal Vasculopathy in a Korean Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Age-Related Macular Degeneration
Lead sponsor: Kyungpook National University Hospital
Sponsor class: OTHER
First posted: 2010-04-21
Enrollment: 215
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study is to investigate whether variants in the LOC387715 locus and the HtrA serine peptidase 1 (HTRA1) gene within the 10q26 locus are associated with polypoidal choroidal vasculopathy and whether they are associated with clinical patterns including angiographic phenotype in a Korean population.

Detailed description: This is a cross-sectional case-control study. One hundred Korean patients with polypoidal choroidal vasculopathy and 100 control subjects were genotyped for the LOC387715 (rs10490924) and the HTRA1 gene polymorphism (rs11200638)

Eligibility criteria: Polypoidal choroidal vasculopathy group

Inclusion Criteria:

* patients older than 60 years of age at onset
* polyp-like terminal aneurysmal dilations with or without branching vascular networks in indocyanine green angiography and subretinal reddish-orange protrusions corresponding to polyp-like lesions

Exclusion Criteria:

* eyes with pathologic myopia, angioid streaks, central serous chorioretinopathy, and other retinal or choroidal diseases

Control group

Inclusion Criteria:

* individuals without retinal diseases and without any signs of polypoidal choroidal vasculopathy or age-related macular degeneration on the bases of comprehensive ophthalmic examination results

Primary outcomes:
measure: Genotyping of LOC387715/HTRA1 of PCV and control groups
timeFrame: 4weeks
Secondary outcomes:
measure: Indocyanine angiographic findings of polypoidal choroidal vasculopathy
timeFrame: 20 minutes
measure: Visual acuity using Snellen chart
timeFrame: 2 x 5 minutes
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: In Taek Kim
state: Kyungsangpookdo
Study officials:
affiliation: Kyungpook National University Hospital
name: In Taek Kim, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gotoh N, Nakanishi H, Hayashi H, Yamada R, Otani A, Tsujikawa A, Yamashiro K, Tamura H, Saito M, Saito K, Iida T, Matsuda F, Yoshimura N. ARMS2 (LOC387715) variants in Japanese patients with exudative age-related macular degeneration and polypoidal choroidal vasculopathy. Am J Ophthalmol. 2009 Jun;147(6):1037-41, 1041.e1-2. doi: 10.1016/j.ajo.2008.12.036. Epub 2009 Mar 9.
Clinical trial NCT02006550: Interrogation of Wnt, Notch and Hedgehog Activity in Primary Tumor Samples
Official title: Interrogation of Wnt, Notch and Hedgehog Activity in Primary Tumor Samples
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Cancer
Keywords: Wnt
Notch
Hedgehog
Tumor Sample
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2013-12-10
Enrollment: 227
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: These are samples derived from discarded tissue obtained through the routine surgical resection of tumors

Brief summary: Cancer results when undifferentiated cells grow in an uncontrolled manner, crowding out normal cells, causing morbidity and ultimately mortality. The cancer stem cell theory suggests that most tumors undergo a process of differentiation through which a relatively rare cancer stem or progenitor cell (CSC) gives rise to more differentiated populations of cells (including transiently amplifying cells) comprising the bulk of the tumor. As a result of this cellular diversity, one or more cells within the tumor are likely to be resistant to therapy. Among cells resistant to a given therapy, only CSCs can repopulate the tumor. A key feature of this resistant subset of CSCs is that they repopulate a tumor resistant to the original intervention. The cellular programs driving the uncontrolled proliferation of many solid tumors result from aberrant activity of Wnt, Shh, and/or Notch signaling pathways in CSC. Thus, therapies that down-regulate the activity of these fundamental pathways in CSCs will be effective in the treatment of cancer. The investigators' research program focuses on the elucidation of signaling mechanisms, control of cellular processes and discovery of small molecules that selectively target Wnt, Shh, and Notch signaling pathways that are fundamental to CSCs. Our preliminary results identified a novel Notch associated protein NACK that functions as a transcriptional co-activator of Notch. Moreover, Nack is expressed in human solid tumors and is required for cell survival and tumor growth in notch -dependent tumor cells. The investigators' aim is to further interrogate the link between Notch and Nack.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with a primary cancer tumor scheduled for a surgery to remove it.

Exclusion Criteria:

* Patients not diagnosed with a primary cancer scheduled for a standard of care (SOC) surgery.

Primary outcomes:
measure: Identify and isolate the cancer stem cell populations from primary tumor samples.
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Anthony Capobianco, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00290550: A Phase IIA Study of MK0457 in Patients With Cancer of the Lung (0457-006)
Official title: A Phase IIA Study Evaluating the Efficacy of MK0457 as a 5-Day Continuous Infusion in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: Advanced Non-Small Cell Lung Cancer
NSCLC
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2006-02-13
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a study to evaluate the effectiveness of an investigational drug in patients with cancer of the lung.


Eligibility criteria: Inclusion Criteria:

* Patients who are at least 18 years of age with cancer of the lung and who have had either no previous treatment or 1 previous treatment for advanced cancer of the lung. Certain other treatments may also be allowed (prior cytotoxic chemotherapy in the adjuvant setting)

Exclusion Criteria:

* Patients who have had treatment with any investigational therapy within the past 30 days are not eligible.
* Patients who have had a disease or medical condition that is not controlled will not be eligible.
* Patients who are pregnant or breastfeeding are not eligible.

Primary outcomes:
measure: Efficacy of MK0457 as a 5 day infusion as measured by radiological exams at baseline and after every other cycle of treatment. After 3 post-treatment radiological assessments, response will be measured after every third cycle.
timeFrame: 5 Days
Secondary outcomes:
measure: Safety and tolerability as measured by duration, intensity (grade) and time of onset of toxicity.
timeFrame: 5 Days
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT02331550: Observational vs. Ablative Treatment for Low-grade Squamous Intraepithelial Lesions.
Official title: Observational vs. Ablative Treatment for Low-grade Squamous Intraepithelial Lesions. Retrospective Paired Cohort Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: LSIL, Low-Grade Squamous Intraepithelial Lesions
Keywords: Low-Grade Squamous Intraepithelial Lesions
Lead sponsor: Saint Thomas Hospital, Panama
Sponsor class: OTHER
First posted: 2015-01-06
Enrollment: 250
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the rate of regression and progression of low-grade squamous intraepithelial lesion comparing expectant vs. ablative treatment.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Low-Grade Squamous Intraepithelial Lesion by cervical cytology.
* Positive Biopsy for Low-Grade Squamous Intraepithelial Lesion after colposcopy.

Exclusion Criteria:

* Serological detection of human immunodeficiency virus (HIV).

Primary outcomes:
measure: Number of patients diagnosed with Low-Grade Squamous Intraepithelial Lesions that progressed to a higher level lesion (High Grade or cervical cancer) when evaluated at 6 and 12 months after diagnosis.
timeFrame: 12 months
Secondary outcomes:
measure: Number of patients diagnosed with Low-Grade Squamous Intraepithelial Lesions that regressed to a higher level lesion (High Grade or cervical cancer) when evaluated at 6 and 12 months after diagnosis.
timeFrame: 12 months
Other outcomes:
Locations:
city: Panama
country: Panama
facility: Saint Thomas H
Study officials:
affiliation: Saint Thomas Hospital, Panama
name: Osvaldo Reyes, MD
role: PRINCIPAL_INVESTIGATOR
References: