louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00200460: A Study Evaluating the Effects of Nebivolol on Blood Pressure in Hypertensive Patients
Official title: A Double-Blind, Multi-Center, Randomized, Placebo-Controlled, Parallel Group Dosing Study Evaluating the Effects of Nebivolol on Blood Pressure in Patients With Mild to Moderate Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Keywords: Nebivolol
Hypertension
Beta-Blocker
Lead sponsor: Mylan Bertek Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2005-09-20
Enrollment: 825
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 evaluate the effects of various doses of nebivolol in patients with mild to moderate hypertension.

Detailed description: This was a multi-center, randomized, double-blind, parallel group, placebo-controlled study of nebivolol over a range of doses in patients with mild to moderate hypertension. The study consisted of 2 phases: screening/washout/single-blind placebo run-in followed by randomization/double-blind treatment. During the double-blind phase, patients received nebivolol or placebo. Patients had 7 scheduled clinical visits during the study.

Eligibility criteria: Inclusion Criteria:

* An average sitting diastolic blood pressure of greater then or equal to 95 mmHg and less then or equal to 109 mmHg at baseline

Exclusion Criteria:

* Recent myocardial infarction or stroke
* Secondary hypertension
* Contraindications to beta-blocker treatment or discontinuation of current antihypertensive therapy
* Pregnancy, nursing, or women of child-bearing potential not using appropriate contraception

Primary outcomes:
measure: The change of the average sitting diastolic blood pressure taken at trough drug plasma level at the end of treatment compared to baseline
Secondary outcomes:
measure: - Sitting SBP
measure: - Supine SBP and DBP
measure: - Standing SBP and DBP
measure: - Response rate
measure: - Correlation between plasma levels
Other outcomes:
Locations:
city: Morgantown
country: United States
facility: Mylan Pharmaceuticals Inc.
state: West Virginia
Study officials:
affiliation: Mylan Pharmaceuticals Inc
name: Betty S. Riggs, MD, MBA
role: STUDY_DIRECTOR
References:
Clinical trial NCT03909360: Drainage or Not for Laparoscopic Cholecystetomy
Official title: Role of Abdominal Drainage for Laparoscopic Cholecystectomy a Prospective Randomised Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cholecystitis
Cholecystolithiasis
Polyps Gallbladder
Adenomyosis of Gallbladder
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2019-04-10
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Surgeons usually choosing drainage tube for laparoscopic cholecystectomy according to their experiences but not guidelines. The investigators design a RCT to evaluate the role of drainage in LC surgery and compare the clinical results between drainage and no drainage.

Detailed description: The investigators design a RCT to evaluate the role of drainage in LC surgery and compare the clinical results between drainage and no drainage.

Compare complications as below betwwen drainage and no drainage groups.

1. VAS
2. Nause and vomiting
3. infection
4. bleeding
5. bile leakage
6. puncture drainage
7. readmission
8. reoperation
9. hospital stay
10. hospital expense

Eligibility criteria: Inclusion Criteria:

* age:18-75 years old
* indicated and planed to receive laparoscopic cholecystectomy

Exclusion Criteria:

* cirrohosis Child Grading B and C
* upper abdominal surgery history
* adjustment of surgical name intraoperative

Primary outcomes:
measure: bleeding Bile leakage
timeFrame: day 1 to one month post LC operation
measure: bile leakage
timeFrame: day 1 to one month post LC operation
measure: Puncture drainage Puncture drainage
timeFrame: day 1 to one month post LC operation
measure: reoperation Reoperation
timeFrame: day 1 to one month post LC operation
measure: readmission
timeFrame: day 1 to one month post LC operation
Secondary outcomes:
measure: hospital stay
timeFrame: day 1 to discharge post LC operation
measure: Hospitalization expenses
timeFrame: day 1 to discharge post LC operation
measure: VAS score
timeFrame: day 1 to discharge post LC operation
measure: Nausea and vomiting
timeFrame: day 1 to discharge post LC operation
measure: infection
timeFrame: day 1 to discharge post LC operation
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The second affiliated hospital of Zhejiang University School of Medicine
state: Zhejiang
Study officials:
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Jiangtao Li, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00819260: Harmonic Scalpel Vs. Electrocautery in Breast Reduction Surgery
Official title: A Randomized Clinical Trial Comparing the Harmonic Scalpel to Electrocautery in Breast Reduction Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hyperplasia
Keywords: Mammaplasty
Electrocoagulation
Breast
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: Ethicon Endo-Surgery
First posted: 2009-01-08
Enrollment: 31
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Purpose: The aims of this randomized clinical trial are to assess and compare 3 different outcomes in women undergoing breast reduction surgery using two different surgical devices: the Harmonic Scalpel and electrocautery.

The three metrics are:

1. the time taken to complete the operation
2. drainage volume in the days immediately following surgery,
3. patient pain in the days immediately following surgery.


Eligibility criteria: Inclusion Criteria:

* Patients are eligible for enrollment if they agree to provide informed consent, can read and speak English, are at least 18 years of age, and are in generally good health.

Exclusion Criteria:

* under 18 years of age

Primary outcomes:
measure: Time for Operation
timeFrame: day of surgery
Secondary outcomes:
measure: Volume of Drainage in Surgical Drains
timeFrame: within one week of surgery
measure: Pain Level in Surgical Sites
timeFrame: first week after surgery
measure: Hematoma
timeFrame: first day after surgery
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
Study officials:
affiliation: DHMC
name: Carolyn L Kerrigan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: DHMC
name: Todd E Burdette, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01482260: Comparative Microarray Analysis in Primary Cutaneous Malignant Melanoma
Official title: Comparative Microarray Analysis of microRNA Expression Profiles in Primary Cutaneous Malignant Melanoma, Cutaneous Malignant Melanoma Metastases and Benign Melanocytic Naevi
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cutaneous Malignant Melanoma
Lead sponsor: Ruhr University of Bochum
Sponsor class: OTHER
First posted: 2011-11-30
Enrollment: 21
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with

* Primary Cutaneous Malignant Melanoma
* Cutaneous Malignant Melanoma Metastases
* Benign Melanocytic Naevi

Brief summary: Perturbations in microRNA (miRNA) expression profiles has been reported for cutaneous malignant melanoma (CMM). This study will be an exploratory analysis by miRNA expression profiling using microarrays.

Detailed description: Perturbations in microRNA (miRNA) expression profiles has been reported for cutaneous malignant melanoma (CMM). With regards to a rapidly growing number of newly discovered miRNA sequences, the availability of up-to-date miRNA expression profiles for primary cutaneous malignant melanoma (PCMM), cutaneous malignant melanoma metastases (CMMM) and benign melanocytic naevi (BMN) is limited. Patients with PCMM, CMMM and BMN are included in the study to perform an exploratory analysis by miRNA expression profiling using microarrays. Expression levels of miRNA candidates will be validated by TaqMan real-time quantitative polymerase chain reaction (RT-PCR).

Eligibility criteria: Inclusion Criteria:

* Primary Cutaneous Malignant Melanoma
* Cutaneous Malignant Melanoma Metastases
* Benign Melanocytic Naevi

Exclusion Criteria:

- Other Skin Cancer than Primary Cutaneous Malignant Melanoma

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bochum
country: Germany
facility: Department of Dermatology, Venereology and Allergology, Ruhr-University Bochum
state: NRW
Study officials:
affiliation: Department of Dermatology, Venereology and Allergology, Ruhr-University Bochum
name: Falk G Bechara, PD Dr.
role: STUDY_DIRECTOR
affiliation: Department of Dermatology, Venereology and Allergology, Ruhr-University Bochum
name: Peter Altmeyer, Prof. Dr.
role: STUDY_CHAIR
References:
citation: Sand M, Skrygan M, Sand D, Georgas D, Gambichler T, Hahn SA, Altmeyer P, Bechara FG. Comparative microarray analysis of microRNA expression profiles in primary cutaneous malignant melanoma, cutaneous malignant melanoma metastases, and benign melanocytic nevi. Cell Tissue Res. 2013 Jan;351(1):85-98. doi: 10.1007/s00441-012-1514-5. Epub 2012 Oct 31.
Clinical trial NCT04702360: ELX/TEZ/IVA Expanded Access Program for Cystic Fibrosis (CF) Patients With at Least One F508del Mutation
Official title: ELX/TEZ/IVA Expanded Access Program for Patients 6 Through 11 Years of Age With Cystic Fibrosis Who Have At Least One F508del Mutation
Study type: EXPANDED_ACCESS
Overall status: APPROVED_FOR_MARKETING
Conditions: Cystic Fibrosis
Lead sponsor: Vertex Pharmaceuticals Incorporated
Sponsor class: INDUSTRY
First posted: 2021-01-08
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD

Brief summary: The purpose of this program is to provide elexacaftor/tezacaftor/ivacaftor (ELX/TEZ/IVA) to CF patients in critical need who are 6 to 11 years of age with at least one F508del mutation in response to unsolicited physician requests.


Eligibility criteria: Key Inclusion Criteria:

* Patients with confirmed diagnosis of CF who have an F/any genotype
* Prior treatment for at least 6 months with an approved alternative CFTR modulator (if the patient is eligible for such treatment)
* Patients with percent predicted forced expiratory volume in 1 second (ppFEV1) \<40 for a minimum of 60 consecutive days before the date of completion of the request form

Key Exclusion Criteria:

* Patients with severe hepatic impairment

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05855460: Estimation of the Tissue and Serum Levels of Interleukin (IL) -35 in Mycosis Fungoides: a Case Control Study
Official title: Estimation of the Tissue and Serum Levels of Interleukin (IL) -35 in Mycosis Fungoides: a Case Control Study.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Mycosis Fungoides
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-05-11
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with mycosis fungoides. Subjects attending plastic surgery units for abdominoplasty will be enrolled as controls.

Brief summary: Tissue and serum samples from 20 MF patients and 20 normal healthy controls will be subjected for biochemical assessments by ELISA (Enzyme- linked immune-sorbent assay) for assessing the level of IL35.

Detailed description: Tissue and serum samples from 20 MF patients and 20 normal healthy controls will be subjected for biochemical assessments by ELISA (Enzyme- linked immune-sorbent assay) for assessing the level of IL35

Eligibility criteria: Inclusion Criteria:

* Patients with mycosis fungoides. Both genders. Age group ≥ 18 years old.

Exclusion Criteria:

* Patients with any other skin diseases. Patients who received treatments for mycosis fungoides in the past three months.

Subjects with history of solid or hematological malignancy as leukemia

Primary outcomes:
measure: To assess and compare tissue and serum levels of interleukin 35 (IL -35) in mycosis fungoides patients and normal controls.
timeFrame: 1 year
Secondary outcomes:
measure: Correlating tissue and serum levels of IL-35 in mycosis fungoides patients with patients age, sex, duration, extent and stage of the disease. L
timeFrame: 1 year
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Cairo University
Study officials:
affiliation: Cairo University
name: Maha Fathy Elmasry, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01822860: Chlorthalidone Compared to Hydrochlorothiazide on Endothelial Function
Official title: The Effect of Chlorthalidone Compared to Hydrochlorothiazide on Endothelial Function in Hypertensive Patients: A Pilot Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Hypertension
Keywords: Hypertension
Endothelial dysfunction
Lead sponsor: Creighton University
Sponsor class: OTHER
First posted: 2013-04-02
Enrollment: 0
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Chlorthalidone will result in improved endothelial function compared to hydrochlorothiazide as measured by flow mediated vasodilatation.

Detailed description: This is a randomized, double-blind, crossover study to evaluate chlorthalidone and hydrochlorothiazide and their effects on endothelial function in hypertensive patients. Subjects will receive chlorthalidone 12.5 mg, hydrochlorothiazide 25 mg, and placebo each for 4 weeks with a 1 week washout between study periods. Sequence of study drugs will be randomized. Flow mediated vasodilatation will be measured at baseline and after each treatment period.

Eligibility criteria: Inclusion Criteria:

* Age 19 or older
* Diagnosis of hypertension
* Current blood pressure \> 120/80 mm Hg

Exclusion Criteria:

* Use of a thiazide-type diuretic within the last 1 month
* Known allergy to any study medications
* History of gout or hyperuricemia
* SCr \>/= 1.8 mg/dl or CrCl \< 25 ml/min
* Pregnancy or breastfeeding or planning to become pregnant during study period
* Dementia or cognitive impairment
* Hypokalemia
* Acute coronary syndrome or stroke within 6 months
* Current use of sildenafil, tadalafil, or vardenafil

Primary outcomes:
measure: Flow mediated vasodilatation
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Creighton University
state: Nebraska
Study officials:
affiliation: Creighton University
name: Ahmed Aboeata, MBBCh
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05786794: Hearing Healthcare Assessment in Rural Communities
Official title: Hearing Healthcare Assessment in Rural Communities (HHARC)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hearing Loss, Adult-Onset
Hearing Loss, Age-Related
Keywords: Patient Navigator
Adult Hearing Screening
Adult Hearing Loss
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2023-03-28
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Approximately 500 patients from 10 rural clinics will be recruited to participate in the trial. All participants will complete baseline surveys and eligible candidates will engage with a Patient Navigator who will assist them in overcoming specific barriers to obtain a diagnostic audiogram with an audiologist.
Primary purpose: DIAGNOSTIC

Brief summary: Adult hearing loss in is the third most common chronic health condition in the United States. Adults living in rural areas face a higher risk of experiencing hearing loss, and more difficulty receiving testing and treatment than adults in urban settings. The goal of this clinical trial is to develop and test a community-based hearing healthcare patient navigation program in rural Kentucky. The main question this study aims to answer is:

-Can the number of rural adults receiving diagnostic hearing tests be increased?

Detailed description: Investigators will pilot test the rural hearing health care patient navigation program (N=500 patients from 10 rural clinics). The program will be evaluated with the following outcome: number of participants obtaining a diagnostic audiogram within past 12 months after enrollment among rural adults

Eligibility criteria: Inclusion Criteria:

* Age 18 years or older)
* Able to speak, understand, and read English.

Exclusion Criteria:

-Under 18

Primary outcomes:
measure: Number of Participants Receiving a Diagnostic Audiogram After Enrollment
timeFrame: From Enrollment to Study Completion at 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky Department of Otolaryngology
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Matthew L Bush, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01847794: HER2 Positive CTC in Advanced Gastric Cancer
Official title: Clinical Significance of HER2 Positive Circulating Tumor Cells(CTCs) in the Peripheral Blood of Patients With Advanced Gastric Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: HER2 Positive Advanced Gastric Cancer
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2013-05-07
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: BASIC_SCIENCE

Brief summary: To identify the correlation of HER2 expression in tissue and peripheral CTC. to identify the HER2 expression in CTCs with clinical prognosis in advanced/metastatic gastric cancer.

Confirm the presence of CTCs are sensitive for monitoring response to chemotherapy.


Eligibility criteria: Inclusion Criteria:

* Having signed informed consent
* Age≥ 18 years old
* HER2 overexpression confirmed by IHC or ISH (IHC 3+,or IHC2+/ISH+)
* Histologically confirmed gastric adenocarcinoma
* Unresectable recurrent or metastatic disease
* Previous neo-adjuvant or adjuvant treatment for gastric cancer, if applicable, more than 6 months
* Measurable disease according to the RECIST criteria
* Karnofsky performance status ≥70
* Life expectancy of ≥3 month
* No prior radiotherapy except radiotherapy at non-target lesion of the study more than 4 weeks
* ALT and AST\<2.5 times ULN (≤5 times ULN in patients with liver metastases)
* Serum albumin level ≥3.0g/dL
* Serum AKP \< 2.5 times ULN
* Serum creatinine \<ULN, and CCr \< 60ml/min
* Bilirubin level \< 1.5 ULN
* WBC\>3,000/mm3, absolute neutrophil count ≥2000/mm3, platelet\>100,000/mm3, Hb\>9g/dl

Exclusion Criteria:

* Previous systemic therapy for metastatic gastric cancer
* Surgery (excluding diagnostic biopsy) within 4 weeks prior to study entry Contraindications of nuclear magnetic resonance image such as fitment of cardiac pacemaker , nerve stimulator, or aneurysm clip, and metallic foreign body in eye ball and so on.
* Allergic constitution or allergic history to protium biologic product or any investigating agents.
* Severe heart disease or such history as recorded congestive heart failure, uncontrolled cardiac arrhythmia, angina pectoris needing medication, cardiac valve disease, severe abnormal ECG findings, cardiac infarction , or retractable hypertension.
* Pregnancy or lactation period
* Other previous malignancy within 5 year, except non-melanoma skin cancer
* Legal incapacity

Primary outcomes:
measure: HER2 positive CTC
timeFrame: 2 months
Secondary outcomes:
measure: clinical significance of HER 2 positive CTC
timeFrame: 2years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking cancer hospital
state: Beijing
Study officials:
affiliation: Peking University
name: Lin Shen, MD. PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06557694: Effect of COVID-19 Infection on Obstertric Complications and Maternal Outcomes
Official title: Effect of COVID-19 Infection on Obstertric Complications and Maternal Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Infection
Obstetric Complication
Maternal Outcomes
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2024-08-16
Enrollment: 260
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This retrospective study was carried out on 260 pregnant women with COVID-19 infection who presented in Tanta University Hospitals in the period from January 2021 to December 2022 with approval from the institutional ethical committee.

Brief summary: This study aimed to evaluate the effect of COVID-19 infection on obstetric complications and maternal outcomes.

Detailed description: During the SARS-CoV-2 pandemic, pregnant women were reported to have a higher susceptibility to COVID-19 infection. Pregnant women who tested positive for SARS-CoV-2 are at higher risk of a severe form of COVID-19, associated with higher rates of intensive care unit (ICU) admission and increased needs for respiratory support, compared to the age-matched non-pregnant population.

Women infected during pregnancy also have an increased risk of adverse pregnancy outcomes including preterm-birth, with a significant proportion secondary to iatrogenic preterm birth due to maternal illness. Infection with SARS-CoV-2 during pregnancy has also been reported to be associated with a higher risk of stillbirth directly or indirectly caused by the virus.

Infected pregnant patients tended to present asymptomatically with pre-Delta and Omicron variants, and symptomatically with Delta variant. A previous systematic review suggested that people who are pregnant did not have an increased risk of SARS-CoV-2 infection or symptomatic COVID-19, but they were at risk of severe COVID-19 compared with those who were not pregnant.

Eligibility criteria: Inclusion Criteria:

* Age from 18 to 40 years.
* Pregnant women with COVID-19 infection diagnosed either by PCR or rapid test.

Exclusion Criteria:

• Patients vaccinated for COVID-19 before or during the current pregnancy.

Primary outcomes:
measure: Pregnancy related complications
timeFrame: For one month
Secondary outcomes:
measure: Intensive care unit admission rate
timeFrame: For one month
measure: Use of mechanical ventilation
timeFrame: For one year
measure: Incidence of death
timeFrame: For one month
measure: Apgar score
timeFrame: For 5 minutes post-intervention
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University
state: El-Gharbia
Study officials:
References: