louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06743295: AI Noise Reduction in Phonak Hearing Aids
Official title: Evaluation of Artificial Intelligence Based Noise Reduction in Phonak Hearing Aid on Patients With Hearing Impairment and Cochlear Implants
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hearing Loss
Keywords: hearing aid
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2024-12-19
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if artificial intelligence- based noise reduction can offer objective improvement in hearing and speech perception for hearing impaired patients.


Eligibility criteria: Inclusion Criteria:

* Patients with hearing impairment not using hearing aids
* Individuals with hearing impairment currently using hearing aids
* Cochlear implant patients with a single-sided implant (using a hearing aid in the opposite ear)

Primary outcomes:
measure: Single-word Testing
timeFrame: Baseline
measure: Sentence Testing
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Aniket Saoji, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04830995: Insulin Sensitivity Response to High-Intensity Training in Insulin Resistance During Pregnancy
Official title: Impact of High-Intensity Interval Training on Insulin Resistance During Pregnancy: A Randomized Control Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: High Intensity Interval Training
Diet, Healthy
Keywords: Training
Insulin Resistance
Pregnancy
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: Heba mohamed Embaby
name: Salwa Elgendy
First posted: 2021-04-05
Enrollment: 40
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: group (A) received HIIT and low diet for four weeks, 3 sessions weekly. While the control group received diet only.
Primary purpose: TREATMENT

Brief summary: Insulin Resistance is one of the common complications that occur during pregnancy. Early intervention is essential to prevent the development of the diseaseThere is evidence that physical inactivity increases the risk of a lot of adverse health problems, including coronary heart disease, type 2 diabetes, breast and colon cancers. It also shortens life expectancy. Pregnancy is a period in the life of women that is often associated with decreased daily physical activity and decreased participation in sports and exercise . In the first few weeks of pregnancy, maternal carbohydrate metabolism is affected by a rise in maternal levels of estrogen and progesterone that stimulates pancreatic β-cell hyperplasia and insulin secretion. As pregnancy progress, pancreatic islet cell hypertrophy continues and there is an increased insulin response to glucose or meal stimulation.

Detailed description: This study was carried out upon twenty multigravida pregnant female between 5-6 months gestation with IR calculated by HOMA test (fasting blood glucose× fasting insulin) ÷ 22.5. Fasting blood glucose was assessed by the method approved by (7, 13) .The test materials for this method were supplied as kits by "Diamond Diagnostics," while Insulin concentrations were stated in formerly frozen and defrosted serum samples by enzyme immunoassay using the human Insulin ELISA kits.

Eligibility criteria: Inclusion Criteria:

* forty multigravida females.
* their age ranged between 25 to 35 years old.
* Body mass index (BMI) \<30kg/ m².

Exclusion Criteria:

* females with pelvic pathology as endometriosis.
* females have irregular menstrual cycles.

Primary outcomes:
measure: Fasting blood glucose level
timeFrame: three months
Secondary outcomes:
measure: Fasting Insulin Level
timeFrame: three months
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Ghada Elrefaye
Study officials:
References:
Clinical trial NCT03321695: A Study of the Safety of Atezolizumab in Participants With Locally Advanced or Metastatic Non Small Cell Lung Cancer in Argentina
Official title: An Observational Study of the Safety of Atezolizumab in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer in Argentina
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carcinoma, Non-small-cell Lung
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2017-10-26
Enrollment: 44
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will include participants with locally advanced or metastatic (Stage IIIB, Stage IV, or recurrent) non-small cell lung cancer (NSCLC) who have received the indication for treatment with atezolizumab, as per local label (disease progression during or following treatment with a prior platinum-containing regimen for locally advanced, unresectable/inoperable or metastatic NSCLC or disease recurrence after treatment with a platinum-based adjuvant/neoadjuvant regimen, and have progressed on an appropriate approved targeted therapy if their tumor has EGFR or ALK gene abnormalities) and who have no contraindication to atezolizumab therapy.

Brief summary: This is a study of the safety and effectiveness of atezolizumab in participants with metastatic non-small cell lung cancer (NSCLC) who have disease progression during or following platinum-containing chemotherapy. Participants also will have progressed on an appropriate approved targeted therapy if their tumor has epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) gene abnormalities treated in common clinical practice settings in Argentina.


Eligibility criteria: Inclusion Criteria:

* Signed an informed consent form submitted to the Administración Nacional de Medicamentos Alimentos y Tecnología Médica (ANMAT)
* Locally advanced or metastatic (Stage IIIB, Stage IV, or recurrent) non-small cell lung cancer (NSCLC)
* Have received at least one dose of atezolizumab as per local label and clinical practice

Exclusion Criteria:

* Contraindicated atezolizumab therapy

Primary outcomes:
measure: Percentage of Participants With Adverse Events
timeFrame: Up to approximately 2 years
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: Up to approximately 2 years
measure: Percentage of Participants With a Confirmed Objective Response (ORR) of Complete Response (CR) or Partial Response (PR)
timeFrame: Up to approximately 2 years
measure: Duration of Response (DOR)
timeFrame: Up to approximately 2 years
measure: Progression-Free Survival (PFS)
timeFrame: Up to approximately 2 years
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Productos Roche S.A. Quimica e Industrial, División Farmacéutica
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT01262495: Testicular Tissue Viability After Cryopreservation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fertility
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2010-12-17
Enrollment: 5
Sex: MALE
Minimum age (years): 15
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: we will use testicular tissue from patient who underwent orchidectomy due to medical reasons and test the viability of the tissue after cryopreservation and de-freezing.


Eligibility criteria: Inclusion Criteria: male patient undergo orchidectomy -

Exclusion Criteria: non viable testicular tissue

-

Primary outcomes:
measure: viable tissue after cryopreservation
timeFrame: 1/1/2011 - 30/12/2012
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
References:
Clinical trial NCT00188695: Combidex USPIO - Ultra-small Superparamagnetic Iron Oxide
Official title: A Pilot Study of MR Imaging With Ultra-small Superparamagnetic Iron Oxide for Pelvic Lymph Node Target Definition
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Uterine Neoplasms
Cervix Neoplasms
Bladder Neoplasms
Prostatic Neoplasms
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Princess Margaret Hospital, Canada
First posted: 2005-09-16
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to test whether or not a new contrast agent called Combidex, a contrast agent formulated from ultra-small superparamagnetic iron oxide (USPIO) improves the ability of Magnetic Resonance Imaging (MRI) to see lymph nodes in the pelvis. It might also help doctors tell whether or not cancer has spread to these lymph nodes. It might allow radiotherapy to be delivered more accurately.


Eligibility criteria: Inclusion Criteria:

* histologically confirmed endometrial, cervix, prostate (cT1-cT3) or bladder cancer
* no distant metastases
* informed consent

Exclusion Criteria:

* confirmed prostate carcinoma and PSA less than or equal to 4 or greater than 100
* radical surgery or prior cryosurgery for prostate carcinoma, previous RT, hormonal manipulation or chemotherapy
* biopsy-proven lymph node involvement
* endometrium or cervix carcinoma who have undergone recent pelvic surgery with the exclusion of D\&C or biopsy
* bladder carcinoma with recent pelvic surgery with the exclusion of TURBT
* previous or concurrent cancers other than superficial basal or squamous cell skin carcinoma unless disease-free for at least 5 yrs
* contraindication to MR imaging
* hip prosthesis
* major medical or psychiatric illness
* patients with known allergy to dextran or iron-containing compounds
* patients with cirrhosis or hemochromatosis
* patients receiving another MR contrast within 2 hrs prior to the ferumoxtran-10

Primary outcomes:
measure: Improved delineation of normal pelvic lymph nodes in patients with uterine, cervical, bladder and prostate cancers.
timeFrame: once at time of imaging
measure: Improved clinical target volume (CTV) definition for the purpose of adjuvant irradiation of pelvic lymph nodes using intensity modulated radiotherapy (IMRT).
timeFrame: once at time of imaging
Secondary outcomes:
measure: Comparison of target lymph node delineation between nodal imaging with USPIO and volume expansion of vascular anatomy.
timeFrame: once at time of imaging
measure: Demonstration of the pattern and distribution of pelvic nodal metastases in patients with uterine, cervical, bladder and prostate cancers.
timeFrame: once at time of imaging
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
Study officials:
affiliation: Princess Margaret Hospital, Canada
name: Michael Milosevic, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00488995: Safety And Efficacy Study Of CP-675,206 In HIV-Infected Patients
Official title: A Phase 2 Study To Evaluate The Safety, Tolerability, Virologic And Immunologic Effect Of Single-Dose CP-675,206 In Patients Infected With Human Immunodeficiency Virus
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Human Immunodeficiency Virus
Keywords: HIV Therapeutic Vaccine
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-06-20
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if CP-675,206, a monoclonal antibody to CTLA4, is safe and well-tolerated, reduces viral load, and improves immune function in patients infected with HIV.


Eligibility criteria: Inclusion Criteria:

* HIV infected man or woman at least 18 years of age who is available for a follow up period of at least 3 months
* Has been on a stable antiretroviral regimen for ≥3 months and willing to remain on current antiretroviral regimen for an additional 3 months or has been off of antiretroviral therapy for at least 8 weeks and willing to remain off of antiretroviral therapy for another 3 months
* Plasma HIV 1 RNA ≥5,000 copies/mL measured by Roche Amplicor HIV 1 Monitor at the screening visit
* CD4 T-cells ≥200 cells/mm3

Exclusion Criteria:

* History of, or significant evidence of risk for, chronic inflammatory or autoimmunedisease (eg, Addison's disease, asthma, celiac disease, multiple sclerosis, Graves disease, Hashimoto's thyroiditis, inflammatory bowel disease, psoriasis, rheumatoid arthritis, systemic lupus erythematosus, etc)
* History of inflammatory bowel disease (eg, Crohn's disease or ulcerative colitis), celiac disease, or other chronic gastrointestinal conditions associated with diarrhea, or current acute colitis of any origin, and any history of diverticulitis (even a single episode) or evidence of diverticulitis at baseline, including evidence limited to CT-scan only
* Exposure within the previous 3 months to a drug known to have immunomodulatory effects (eg, IL 2)

Primary outcomes:
measure: Maximum reduction in HIV plasma RNA between Baseline and Week 12 Maximum increase in CD4+ cell count between Baseline and Week 12
Secondary outcomes:
measure: Change from baseline in CD8+ cell count, CD4/CD8, and lymphocyte phenotype through Week 12
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT03027895: Endoscopic Ultrasound-guided Drainage of Walled Off Necrosis (WON)
Official title: Endoscopic Ultrasound-guided Drainage of Walled Off Necrosis (WON)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pancreatic Pseudocyst
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2017-01-23
Enrollment: 256
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
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 compare the effect of lumen-apposing metal stent (LAMS) and double pigtail plastic stents (DPPSs) on the drainage of pancreatic walled-off necrosis (WON), mainly to observe the efficacy and safety of LAMS for WON.

Detailed description: Patient with pancreatic walled-off necrosis (WON) would be treated randomized with lumen-apposing metal stent (LAMS) or double pigtail plastic stents (DPPSs) under the guidance of Endoscopic Ultrasonography. The investigators compare the effect of the two stents, including technical success, clinical success, adverse event, recurrence, and so on.

Eligibility criteria: Inclusion Criteria:

1. Subject with ages from 18-80 years old
2. Subject with pancreatic pseudocysts confirmed by CT
3. Subject with a history of MSAP or SAP, the pseudocysts were formed more than 3 months
4. The size of pseudocyst is more than 6 cm, and the cyst adjacent to the gastric wall
5. Subject has the symptoms related with the pseudocyst
6. The consent form has been signed

Exclusion Criteria:

1. Subject is younger than 18 years or older than 80 years
2. Pancreatic pseudocyst communicate with the main pancreatic duct
3. Subject can't accept the endoscopic procedure
4. Pancreatic pseudocyst with infection or subject diagnosed with pancreatic abscess
5. The distance between gastric and the wall of the pseudocyst is more than 1 cm
6. Subject with 2 or more than 2 cysts
7. Subject has blood coagulation dysfunction
8. Pregnant or subject has mental disorders

Primary outcomes:
measure: clinical success
timeFrame: uo to 1 months
Secondary outcomes:
measure: adverse event
timeFrame: up to 2months/ stent remove
measure: recurrence rate
timeFrame: up to 12 months
measure: technical success
timeFrame: up to 48 hours
Other outcomes:
Locations:
Study officials:
References:
citation: Zhu HY, Xie P, Song YX, Li ZS, Jin ZD, Du YQ. Lumen-apposing metal stents (LAMS) versus plastic stents for EUS-guided drainage of walled-off necrosis (WON) (LVPWON): study protocol for a multicenter randomized controlled trial. Trials. 2018 Oct 11;19(1):549. doi: 10.1186/s13063-018-2901-3.
Clinical trial NCT03911895: Impact of Stent Length on Short Term Outcomes in Patients With Stable Coronary Disease Undergoing PCI
Official title: Impact of Stent Length on Short Term Outcomes in Patients With Stable Coronary Artery Disease Undergoing PCI
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stable Chronic Angina
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-04-11
Enrollment: 1
Sex: ALL
Minimum age (years): 25
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with stable coronary artery disease undergoing PCI

Brief summary: Impact of stent length on short term outcomes in patients with stable coronary artery disease undergoing PCI

Detailed description: Impact of stent length on short term outcomes in patients with stable coronary artery disease undergoing PCI. The investigators will follow up patient clinically and use lab investigation.

Eligibility criteria: Inclusion Criteria:

* patient was CAD referred for elective PC as single vessel

Exclusion Criteria:

* patients admitted ACS patients with primary PCI PTCA without stenting No complete revascularization PCI-related coronary complication (diessaction,no really)

Primary outcomes:
measure: Impact of stent length on short term outcomes in patients with stable coronary artery disease undergoing PCI
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Mohamed abdelbast
Study officials:
References:
Clinical trial NCT01133795: Midodrine and Albumin for Cirrhotic Patients With Functional Renal Impairment
Official title: Effect of Administration of Intravenous Albumin and Oral Midodrine on Renal Function in Patients With Cirrhosis and Functional Renal Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cirrhosis
Renal Failure
Keywords: cirrhosis
renal failure
hepatorenal syndrome
albumine
midodrine
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2010-05-31
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of the study was evaluate the effect of administration of midodrine and albumin on renal function in patients with cirrhosis and creatinine greater than 1,2mg/dl.

Detailed description: Twenty patients with cirrhosis and functional renal impairment, defined by a serum creatinine greater than 1,2mg/dl, will be included. Patients will receive daily midodrine at a dose of 10mg tid and 40g of albumin at 15-day interval. The follow-up period will be of 12 weeks. In all patients, liver and renal function, and vasoactive hormones (plasma renin activity, aldosterone, noradrenaline, ADH, endothelin and anf)will be determined at baseline conditions. At this moment, glomerular filtration rate and renal plasma flow determined by isotopic techniques as ambulatory blood pressure monitoring through a 24-hour period will be performed too. All these determinations will be repeated at 4 and 12 weeks. During the study period, just before the albumin infusions, blood will be drawn for creatinine and electrolytes determinations and these will be recorded as well physical examination performed.

Eligibility criteria: Inclusion Criteria:

* Liver Cirrhosis
* Serum Creatinine greater than 1,2 mg/dL
* to have given written informed consent

Exclusion Criteria:

* pregnancy
* Systolic blood pressure above 150mmHg and/or diastolic blood pressure above 90mmHg
* Previous treatment with transjugular intrahepatic portosystemic shunt (TIPS) or surgical shunts
* Antibiotic treatment in the previous 7 days before inclusion, except for prophylaxis of spontaneous bacterial peritonitis
* infection by HIV
* contraindications for albumin and/or midodrine use

Primary outcomes:
measure: Changes in glomerular filtration rate assessed by isotopic methods
timeFrame: at 12 weeks of treatment
Secondary outcomes:
measure: changes in arterial pressure as assessed by continuous ambulatory arterial pressure
timeFrame: at 12 weeks of treatment
measure: changes in plasma renin activity
timeFrame: at 12 weeks of treatment
measure: changes in aldosterone concentration
timeFrame: at 12 weeks of treatment
measure: changes in norepinephrine concentration
timeFrame: at 12 weeks of treatment
Other outcomes:
Locations:
city: Villarroel 170,Barcelona
country: Spain
facility: Hospital Clinic
state: Barcelona
Study officials:
affiliation: Hospital Clinic of Barcelona
name: Pere Ginès, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02929095: The Effect of Remifentanil-dexmedetomidine Compared With Remifentanil-midazolam on Patient's Satisfaction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Arterial Occlusive Disease
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2016-10-10
Enrollment: 70
Sex: MALE
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Percutaneous trans-arterial angioplasty(PTA) is one of the peripheral arterial occlusive disease(PAOD) treatment. During and after PTA, ischemia-reperfusion pain is induced so proper analgesia is important. ischemia-reperfusion injury is due to reactive oxygen species. Dexmedetomidine has analgesic, sedative and anti oxidant effect. So the investigators research the patient's satisfaction that are given the dexmedetomidine during PTA procedure.


Eligibility criteria: Inclusion Criteria:

* patients who are scheduled to undergo percutaneous trans-arterial angioplasty
* American Society of Anesthesiologists (ASA) class I, II, III

Exclusion Criteria: Subjects are ineligible if they have the below condition

* psychiatric medication
* myocardial infarction within 1 year
* cardiac surgery within 1 year
* heart failure
* fever (\>38 degree)
* uncontrolled hypertension
* cognitive dysfunction
* disabling mental change disorder
* being unable to communicate or speak Korean

Primary outcomes:
measure: patient's satisfaction
timeFrame: 1 hour after the procedure (PTA)
measure: patient's satisfaction
timeFrame: 6 hours after the procedure (PTA)
measure: patient's satisfaction
timeFrame: 12 hours after the procedure (PTA)
measure: patient's satisfaction
timeFrame: 24 hours after the procedure (PTA)
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anaesthesiology and Pain Medicine, Yonsei University College of Medicine
Study officials:
References: