louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03921476: Acne and Mood: Impact of Treatment on Depression, Anxiety, and Sexual Function
Official title: Acne and Mood: Impact of Treatment on Depression, Anxiety, and Sexual Function
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Acne Vulgaris
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2019-04-19
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female patients who have acne vulgaris being treated with spironolactone or oral antibiotics.

Brief summary: This study seeks to examine if there is any relationship between spironolactone use prescribed for acne vulgaris and depression, anxiety, and/or sexual function.


Eligibility criteria: Inclusion Criteria:

Female subjects between 18 and 65 years of age currently taking spironolactone for a diagnosis of acne vulgaris

OR

Female subjects between 18 and 65 years of age currently taking oral antibiotics for a diagnosis of acne vulgaris

AND Subjects able to complete an online survey in English

Exclusion Criteria:

Subjects less than 18 years of age or older than 65 years of age Subjects that have ever been diagnosed with any mood disorder by a clinician prior to starting spironolactone (history of mood disorder or current mood disorder) Subjects taking hormonal contraception (including but not limited to oral contraceptive pills) for a duration of less than 6 months Subjects that have ever been diagnosed with any type of sexual dysfunction prior to starting spironolactone Subjects not able to complete an online survey in English Subjects taking oral isotretinoin for a diagnosis of acne Subjects that are currently pregnant

Primary outcomes:
measure: Percent correlation between spironolactone use for acne vulgaris and increased prevalence of depression.
timeFrame: one week
measure: Percent correlation between spironolactone use for acne vulgaris and increased prevalence of anxiety.
timeFrame: two weeks
measure: Percent correlation between spironolactone use for acne vulgaris and increased prevalence of sexual dysfunction.
timeFrame: four weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Northwestern University
name: Bethanee Schlosser, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00932776: Tracheobronchial Secretion Removal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiration, Artificial
Respiratory Insufficiency
Lead sponsor: University of Milano Bicocca
Sponsor class: OTHER
First posted: 2009-07-03
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: Patients undergoing intubation and mechanical ventilation require removal of secretion by means of trachoebronchial suctioning. Timing of the procedure is mainly based on clinical parameters. TBA Care® is a new commercially available device designed to generate a signal when secretions are present in the respiratory tract of intubated patients, thus indicating the need for endotracheal suctioning only when necessary and prior to clinical deterioration. In a prospective randomized trial in intubated and mechanically ventilated patients of a general ICU the researchers investigated the efficacy of TBA Care® in detecting the presence of retained secretions compared to the standard indicators.


Eligibility criteria: Inclusion Criteria:

* age greater than 18 years
* presence of an endotracheal tube to provide mechanical ventilation
* expected duration of mechanical ventilation greater than 48 hours.

Exclusion Criteria:

* age \< 18 years, pregnancy
* presence of active bronchial bleeding

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Monza
country: Italy
facility: A.O. San Gerardo
state: MB
Study officials:
References:
citation: Lucchini A, Zanella A, Bellani G, Gariboldi R, Foti G, Pesenti A, Fumagalli R. Tracheal secretion management in the mechanically ventilated patient: comparison of standard assessment and an acoustic secretion detector. Respir Care. 2011 May;56(5):596-603. doi: 10.4187/respcare.00909. Epub 2011 Jan 27.
Clinical trial NCT01693276: Gemcitabine/Abraxane Chemotherapy and Dose Escalated Radiotherapy for Locally Advanced, Unresectable Pancreatic Cancer
Official title: Gemcitabine/Abraxane Chemotherapy and Dose Escalated Radiotherapy for Locally Advanced, Unresectable Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Pancreatic Cancer
Keywords: pancreatic cancer
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
First posted: 2012-09-26
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will analyze the effects, good and/or bad, of the drug Abraxane in combination with gemcitabine and gemcitabine with concurrent radiation therapy for patients with locally advanced pancreatic cancer that cannot be removed by surgery. All of the medications used in this study are FDA-approved for use in patients with pancreatic cancer.

Detailed description: The long term goal is to improve survival of patients with unresectable pancreatic cancer. Additional potential benefits include increased probability of local control and decreased distant metastases.

Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically proven carcinoma of the pancreas that is locally advanced
* ECOG performance status 0- 2
* Adequate labs
* No prior abdominal radiation therapy
* No other concurrent clinically evident malignancy, except inactive nonmelanoma skin cancer, inactive cervical cancer, or other cancer for which the patient has been disease-free for 5 years
* All disease must be encompassed within a radiotherapy portal
* Not pregnant or nursing

Exclusion Criteria:

* Patient has metastatic disease on radiological staging
* systemic therapy.
* Patient has known active infection with HIV, hepatitis C or hepatitis B
* Patient has serious medical risk factors involving any of the major organ systems such that the Investigator considers it unsafe for the patient to receive an experimental research drug.
* Patient is deemed to be have obvious resectable disease at presentation
* Received any investigational agent within a month prior to enrollment.
* Neuroendocrine tumors of the pancreas

Primary outcomes:
measure: Increase overall survival
timeFrame: 23 months
Secondary outcomes:
measure: Rate of local control
timeFrame: baseline to average up to 24 weeks
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
Study officials:
affiliation: University of Cincinnati
name: Olugbenga Olowokure, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Cincinnati
name: Michelle Mierzwa, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01147276: Vildagliptin and the Glucagon Response to Hypoglycemia in Type 1 Diabetes
Official title: Study of the Effect of Vildagliptin on Glucagon Counterregulation Response During Hypoglycemia in Patients With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes
Hypoglycemia
Keywords: DPP-4
GLP-1
Glucagon
Catecholamines
Counterregulation
Type 1 diabetes
Lead sponsor: Lund University
Sponsor class: OTHER
First posted: 2010-06-22
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The study examines whether DPP-4 inhibition by vildagliptin affects the glucagon counterregulatory response to hypoglycemia in type 1 diabetes.

Detailed description: Vildagliptin (50 mg BID) or placebo is given as add-on to insulin treatment for four weeks in patients with type 1 diabetes. Then, a hypoglycemic clamp (2.5 mmol/l glucose) is undertaken with the determination of glucagon.

Eligibility criteria: Inclusion Criteria:

* Type 1 diabetes
* Age \>18 years
* HbA1c 6.5-8,5%

Exclusion Criteria:

* Pregnancy
* Lactation
* Acute infection
* Liver disease
* Treatment with cortisol

Primary outcomes:
measure: Glucagon response to hypoglycemia
timeFrame: 45 min
Secondary outcomes:
measure: Catecholamine response to hypoglycemic
timeFrame: 45 min
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Department of Clinical Sciences Lund, Lund University
Study officials:
affiliation: Lund University
name: Bo Ahrén, PhD MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Farngren J, Persson M, Schweizer A, Foley JE, Ahren B. Vildagliptin reduces glucagon during hyperglycemia and sustains glucagon counterregulation during hypoglycemia in type 1 diabetes. J Clin Endocrinol Metab. 2012 Oct;97(10):3799-806. doi: 10.1210/jc.2012-2332. Epub 2012 Aug 1.
Clinical trial NCT04167176: Comparison of Analgesic Efficacy of US Guided ESP Block With Port Site Infiltration Following Laparoscopic Cholecystectomy
Official title: Comparison of Analgesic Efficacy of Ultrasound Guided Erector Spinae Plane Block With Port Site Infiltration Following Laparoscopic Cholecystectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Keywords: Cholecystectomy
ESP block
Port Site Infiltration
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-11-18
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To compare the efficacy of ultrasonography (USG)-guided bilateral Erector spinae plane block (ESPB) with port-site infiltration using bupivacaine for post-operative analgesia after laparoscopic cholecystectomy with a hypothesis that both Erector spinae plane block and port-site infiltration are effective in providing post-operative analgesia.


Eligibility criteria: Inclusion Criteria:

* patients with the American Society of Anesthesiologists (ASA) physical status I/II,
* Age between 18 and 60 years with a body mass index (BMI) of 18-35 kg/m2,
* Patients scheduled for elective laparoscopic cholecystectomy.

Exclusion Criteria:

* Allergy to local anaesthetics,
* Infection at the site of injection,

  •, Coagulopathy,
* Chronic pain syndromes,
* Prolonged opioid medication,
* Patients who received any analgesic 24 h before surgery

Primary outcomes:
measure: Total postoperative opioid consumption.
timeFrame: 24 hours postoperatively
Secondary outcomes:
measure: Pain scores;Numerical Rating Scale (NRS) at rest and when coughing
timeFrame: at 1, 2,4 , 8, 16 and 24 hours postoperatively.
measure: •Cumulative postoperative analgesic consumption
timeFrame: 24 hours postoperatively
measure: •Heart Rate (HR)
timeFrame: Intraoperatively at 0, 5,10, 20, and 30 minutes. Then every 15 min thereafter till the end of surgery
measure: •Mean Arterial Pressure (MAP)
timeFrame: Intraoperatively at 0, 5,10, 20, and 30 minutes. Then every 15 min thereafter till the end of surgery
measure: Incidence and severity Postoperative nausea & vomiting (PONV).
timeFrame: 24 hours postoperatively
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University hospital
state: Asyut Governorate
Study officials:
References:
Clinical trial NCT00467376: Insulin Glulisine, Insulin Lispro and Insulin Glargine in Type 1 or 2 Diabetes Mellitus
Official title: 12-week, Multicenter, Controlled, Open, 3:1 Randomized, Parallel Clinical Trial Comparing Insulin Glulisine With Regular Human Insulin (Insulin Lispro) Injected Subcutaneously in Subjects With Type 1 or 2 Diabetes Mellitus Also Using Lantus (Insulin Glargine)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2007-04-30
Enrollment: 485
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Primary:

* To compare the efficacy and safety of Insulin Glulisine to Insulin Lispro in subjects with type 1 or type 2 diabetes mellitus.
* To compare the frequency of hypoglycemia of Insulin Glulisine to Insulin Lispro.

Secondary:

* To compare Insulin Glulisine to Insulin Lispro in terms of the change in HbA1c at weeks 12, blood glucose parameters, insulin doses and treatment satisfaction in subjects with type 1 or type 2 diabetes mellitus


Eligibility criteria: Inclusion Criteria:

* Type 1 or type 2 diabetic patients
* Measure HbA1c 6.5% to 11.0% at visit 1
* More than 3 months of continuous insulin treatment immediately prior to study entry

Exclusion Criteria:

* Pregnant women

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Hypoglycemic episodes
timeFrame: From the beginning to end of the study
measure: Change in HbA1c
timeFrame: From baseline to endpoint
measure: Adverse events
timeFrame: From the beginning to the end of study
Secondary outcomes:
measure: Change in HbA1c
timeFrame: From baseline to weeks 12
measure: blood glucose parameters, hypoglycemic episodes and dosage of the mealtime and Lantus.
timeFrame: from baseline to week 12
Other outcomes:
Locations:
city: Beijing
country: China
facility: Sanofi-Aventis
Study officials:
affiliation: Sanofi
name: Jing Fu
role: STUDY_DIRECTOR
References:
Clinical trial NCT03116776: Walnut Shell Glasses Moxibustion for Dry Eye Syndrome
Official title: Walnut Shell Glasses Moxibustion for Dry Eye Syndrome: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dry Eye
Keywords: walnut shell glasses moxibustion
dry eye
randomized controlled trial
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2017-04-17
Enrollment: 128
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: This trial is designed to evaluate the efficacy of walnut shell glasses moxibustion for dry eye syndrome compared with sodium hyaluronate eye drops.


Eligibility criteria: Inclusion Criteria:

1. eyes are in line with dry eye diagnostic criteria.
2. Age 18 to 75 years,
3. signed informed consent, voluntary adherence to treatment for more than 1 month.

Exclusion Criteria:

1. combined with other eye disease (such as conjunctiva, cornea and iris have significant lesions).
2. eye surgery within 3 months.
3. pregnant or lactating women.
4. oral the drugs which could inhibit lacrimal gland secretion.
5. severe meibomian gland dysfunction.
6. severe eye burns, chemical injury patients.
7. combined with cardiovascular and cerebrovascular, liver, kidney and hematopoietic system and other serious primary disease, mental patients.
8. patients with Sjogren's syndrome.
9. patients who are participating in other drug clinical trials.
10. patients who are using other drugs or therapies for the treatment of dry eyes.

Primary outcomes:
measure: change from baseline in OSDI score
timeFrame: week 4, week 16, week 28
Secondary outcomes:
measure: the efficacy of Walnut Shell Glasses Moxibustion
timeFrame: week 4, week 16, week 28
measure: change from baseline in mean weekly OSDI score
timeFrame: week 1-4, week 16, week 28
measure: change from baseline in VAS of eye discomfort
timeFrame: week 4, week 16, week 28
measure: change from baseline in mean daily VAS score
timeFrame: week 1-4, week 16, week 28
measure: change from baseline in BUT
timeFrame: week 2, week 4
measure: change from baseline in SchimerⅠtext
timeFrame: week 2, week 4
measure: change from baseline in corneal fluorescence staining scores
timeFrame: week 2, week 4
measure: patiant's expectations for moxibustion
timeFrame: baseline
Other outcomes:
Locations:
city: Beijing
country: China
facility: Guang'anmen Hospital, China Academy of Chinese Medical Sceince
state: Beijing
city: Beijing
country: China
facility: Guang'anmen Hospital, China Academy of Chinese Medical Science
state: Beijing
Study officials:
affiliation: Department of Acupuncture, Guang' anmen hospital，China Academy of Chinese Medical Science, Beijing(100053), China
name: Weiwei Fu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03979976: Ramipril, Endothelial Function and Endothelial Progenitor Cells in Patients With Systemic Lupus Erythematosus
Official title: Ramipril Improves Endothelial Function and Endothelial Progenitor Cells in Patients With Systemic Lupus Erythematosus: a Randomized and Controlled Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Systemic Lupus Erythematosus
Keywords: systemic lupus erythematosus
endothelium
ramipril
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2019-06-10
Enrollment: 37
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study was to evaluate the effect of ramipril on the endothelial function and on the number of endothelial progenitor cells (EPCs) in systemic lupus erythematosus (SLE) patients.

Detailed description: The early detection of additional risk factor for cardiovascular diseases (CVD) such as endothelial dysfunction and low number of EPC in SLE patients, and an intervention proven effective could reduce the cardiovascular morbidity and mortality. No study assessed the effect of ramipril on endothelial function and EPCs in SLE patients.

Eligibility criteria: Inclusion Criteria:

* SLE according 1997 modified American College Rheumatology criteria
* age older than 18 years
* stable treatment for lupus for at least 3 months

Exclusion Criteria:

* previous coronary artery disease
* hypertension
* dyslipidemia (LDL\>149 mg/dL)
* renal insufficiency (creatinine ≥1.4 mg/dL)
* diabetes
* smoking
* obesity (BMI≥30)
* pregnancy
* menopause
* patients taking statins or angiotensin convertor enzyme inhibitor within the last 6 months

Primary outcomes:
measure: Endothelial function - Variation of Flow mediated dilation percentage
timeFrame: 12 weeks
measure: Number of endothelial progenitor cells (EPC)
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Federal University of São Paulo
Study officials:
affiliation: Universidade Federal de São Paulo
name: Emilia I Sato, MD, PhD
role: STUDY_CHAIR
References:
citation: Oliveira ACD, Arismendi MI, Machado LSG, Sato EI. Ramipril Improves Endothelial Function and Increases the Number of Endothelial Progenitor Cells in Patients With Systemic Lupus Erythematosus. J Clin Rheumatol. 2022 Oct 1;28(7):349-353. doi: 10.1097/RHU.0000000000001869. Epub 2022 Jun 8.
Clinical trial NCT04614376: Alzheimer's and Blood Glucose Levels
Official title: A Machine Learning Approach to Alzheimer's Detection From Continuous Blood Glucose Monitoring Data
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Mild Cognitive Impairment
Alzheimer Disease
Lead sponsor: Bio Conscious Technologies Inc.
Sponsor class: INDUSTRY
First posted: 2020-11-04
Enrollment: 100
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population is drawn from older individuals (at least 50 years of age) with or without MCI or AD.

Brief summary: The Alzheimer's and Blood Glucose Levels Study is researching the differences in blood glucose levels between people with and without Mild Cognitive Impairment or Alzheimer's disease with the aim of early detection of Alzheimer's Disease.

Detailed description: This study will collect continuous glucose monitor (CGM) data from participants already using CGMs to better understand the relationship between Alzheimer's Disease and blood glucose levels. This study will use the " Endobits Companion " app for data collection. The Endobits Companion app is freely available for Android and iOS mobile devices, and was designed to keep track of patients diabetes management through a journal and relay this information with their CGM readings to their caring physician.

Eligibility criteria: Inclusion Criteria:

* For the case group: have been diagnosed with MCI or AD within the past 5 years.
* For the control group: have not been diagnosed with MCI or AD or another major dementia disease
* Currently using a continuous glucose monitor (CGM).
* Willing and able to provide informed consent, and to have their data collected through the Endobits Companion app. If the participant themself is unable to provide informed consent, it will be sought from their primary caregiver.

Exclusion Criteria:

* Patients younger than 50 years of age.
* Patients with a BMI lower than 18 or higher than 35.
* Patients with a major psychiatric illness (e.g., major depressive disorder, schizophrenia, bipolar disorder)
* Patients diagnosed with another major dementia disease, including vascular dementia, Lewy Body disease, Huntington's disease, Creutzfeldt-Jakob disease, and Parkinson's disease.

Primary outcomes:
measure: Blood Glucose Levels
timeFrame: This will be measured throughout the study which is a period of up to 90 days.
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Bio Conscious Technologies Inc.
state: British Columbia
Study officials:
References:
Clinical trial NCT05025176: Hypotension Prediction Index: Correlations Between Invasive and Non-invasive Pressure Points.
Official title: Hypotension Prediction Index: Correlations Between Invasive and Non-invasive Pressure Points
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Hypotension
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2021-08-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patents undergoing surgery with a planner arterial catheter placement

Brief summary: To evaluate the clinical performance of the Hypotension Prediction Index obtained from the continuous, non-invasive Clear Sight monitor.

Detailed description: To evaluate the clinical performance of the Hypotension Prediction Index obtained from the continuous, non-invasive ClearSight monitor.

Eligibility criteria: Inclusion Criteria:

* All Patients 18 years or older undergoing surgery with the use of general anesthesia and with planned arterial catheter placement and use of the HPI monitor.

Exclusion Criteria:

* Adults unable to consent
* Individuals who are not yet adults ( infants, children teenagers)
* Pregnant Women
* Prisoners

Primary outcomes:
measure: HPI
timeFrame: During surgical procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis Health System
state: California
Study officials:
References: