louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02748070: Perioperative Oral Steroids for Chronic Rhinosinusitis Without Polyps (CRSsNP)
Official title: The Role of Perioperative Systemic Steroids in Patients With Chronic Rhinosinusitis Without Polyps (CRSsNP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Rhinosinusitis
Endoscopic Sinus Surgery
Chronic Rhinosinusitis Without Polyps
Oral Steroids
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2016-04-22
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: While oral steroids have been shown to be effective in the management of patients with chronic rhinosinusitis with polyps, its role in treating chronic rhinosinusitis without polyps (CRSsNP) is ambiguous. Despite a lack of strong clinical evidence to suggest a benefit in this disease state, steroids are often prescribed as a component of post-operative care after sinus surgery for patients without polyps. Oral steroids carry with them significant adverse effects, and should be prescribed thoughtfully. The aims of this study are to determine if oral steroids in the peri-operative period improves patient outcomes in CRS without polyps.


Eligibility criteria: Inclusion Criteria:

* CRSsNP as defined by Clinical Practice Guideline (Update) on Adult Sinusitis
* scheduled to undergo endoscopic sinus surgery

Exclusion Criteria:

* chronic rhinosinusitis with polyps (CRSwNP)
* Aspirin exacerbated respiratory disease
* Cystic fibrosis
* Immunosuppressive states (Human immunodeficiency virus, transplant)
* Oral steroid use within 30 days of surgery

Primary outcomes:
measure: Sino-nasal Outcome Test (SNOT-22) Over Time
timeFrame: Baseline, 1, week, 1 month, 3 months, and 6 months
measure: Lund Kennedy Endoscopy Score Over Time
timeFrame: Baseline, 1, week, 1 month, 3 months, and 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Julia E Noel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Michael T Chang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Peter H Hwang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chang MT, Noel J, Ayoub NF, Qian ZJ, Dholakia S, Nayak JV, Patel ZM, Hwang PH. Oral Corticosteroids Following Endoscopic Sinus Surgery for Chronic Rhinosinusitis Without Nasal Polyposis: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2021 May 1;147(5):434-441. doi: 10.1001/jamaoto.2021.0011.
Clinical trial NCT06134570: ALDH1A1 Expression in Invasive Mammary Carcinoma
Official title: ALDH1A1 as A Stem Cell Marker and Its Correlation With the Clinico-pathological Parameters in Invasive Mammary Carcinoma
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Breast Cancer
Keywords: breast cancer
CSCs
ALDH1A1
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 60
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: sixty paraffin blocks of breast carcinoma collected from the archive of Pathology Department of Sohag Faculty of Medicine

Brief summary: ALDH1A1 isozyme oxidizes Retinaldehyde to retinoic acid, which regulates the expression of the genes involved in tumor-initiating stem-like cells, thereby initiating tumor growth and resistance to drugs.

Much emphasis has been focused on ALDH1A1 as a CSC marker. High expression of ALDH1A1 has been reported as a poor prognostic marker in several tumor types and is associated with poor patient outcomes .

Detailed description: Breast cancer is one of the most common cancers among women. it is a heterogenous disease. several factors affect the prognosis of breast cancer. CSCs markers are one of the emerging prognostic biomarkers.

ALDH1A1 isozyme oxidizes Retinaldehyde to retinoic acid, which regulates the expression of the genes involved in tumor-initiating stem-like cells, thereby initiating tumor growth and resistance to drugs.

Much emphasis has been focused on ALDH1A1 as a CSC marker. High expression of ALDH1A1 has been reported as a poor prognostic marker in several tumor types and is associated with poor patient outcomes .

Eligibility criteria: Inclusion Criteria:

* Patients with invasive mammary carcinoma carcinoma and underwent surgery

Exclusion Criteria:

* Cases received pre-operative chemotherapy or radiotherapy.
* Cases with insufficient clinical data.

Primary outcomes:
measure: evaluate expression of ALDH1A1 in invasive mammary carcinoma
timeFrame: 4 month
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Faculty of Medicine
Study officials:
References:
Clinical trial NCT03929770: Swan-Ganz Catheter Insertion
Official title: The Effect of Pause at the Right Ventricle on Success Rate of Final Placement in Swan-Ganz Catheterization
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Swan-Ganz Catheter Insertion
Keywords: Swan-Ganz catheter
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: SMG-SNU Boramae Medical Center
First posted: 2019-04-29
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this prospective randomized controlled study is to investigate the effect of pause of advancement of the Swan-Ganz catheter, which is to check whether the Swan-Ganz catheter arrive exactly at the right ventricle or not, on success rate of final placement and required time in Swan-Ganz catheterization.

The question which the investigators are trying to answer is: Continuous advancement of Swan-Ganz catheter without intended pause in the right ventricle to check whether the Swan-Ganz catheter arrive exactly at the right ventricle will decrease the trial number and required time to success final placement of Swan-Ganz catheter?

Detailed description: Many clinicians pause advancement of Swan-Ganz catheter to check whether the Swan-Ganz catheter arrive exactly at the right ventricle or not.

The hypothesis of this study is that the intended pause during advancement of Swan-Ganz catheter in the right ventricle induce failure in advancing of it into the pulmonary artery, and that it increase the required time for final placement of it into the pulmonary artery.

Eligibility criteria: Inclusion Criteria:

* The patients who need to Swan-Ganz catheterization for heart surgeries

Exclusion Criteria:

* Who doesn't agree to enroll
* Who has thrombus in the heart or the vena cavas.

Primary outcomes:
measure: trial number (n)
timeFrame: during Swan-Ganz catheterization procedure
measure: Success rate (%)
timeFrame: during Swan-Ganz catheterization procedure
measure: required time (seconds)
timeFrame: during Swan-Ganz catheterization procedure
Secondary outcomes:
measure: incidence of arrhythmia (n)
timeFrame: during Swan-Ganz catheterization procedure
measure: direction of placement of Swan-Ganz catheter (n)
timeFrame: during Swan-Ganz catheterization procedure
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Boramae Hospital
Study officials:
affiliation: SMG-SNU Boramae Medical Center
name: Jung-Man Lee, M.D.,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00547170: Doxycycline Prophylaxis at Vacuum Aspiration Trial
Official title: Efficacy and Side-Effects of Two Dosing Regimens of Doxycycline at Surgical Abortion: A Randomized Double-Blind Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Endometritis
Keywords: pelvic infection
abortion
doxycycline
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Tu Du Hospital
First posted: 2007-10-22
Enrollment: 1000
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: This study is a randomized, double-blinded, controlled trial comparing two regimens of doxycycline for the prevention of infection after surgical abortion. One thousand women undergoing surgical abortion in the first trimester will be enrolled from the clinic at Tu Du Hospital, Ho Chi Minh City, Vietnam. The standard regimen has been 100 mg twice daily for 5 days after the abortion. Subjects will be randomized to the standard regimen or to take 200 mg doxycycline pre-operatively. Subjects found to have a positive Chlamydia EIA test will receive a 7-day course of doxycycline regardless of study group. Subjects will complete questionnaires of symptoms, including nausea and emesis in the recovery room after the procedure and at a single follow-up visit two weeks later. The primary outcome will be infection after abortion, defined below. Analyses will be performed including and excluding Chlamydia-positive subjects. Secondary outcomes will be the proportion with nausea, emesis, and other side-effects.


Eligibility criteria: Inclusion Criteria.

1. Women seeking elective surgical abortion
2. Gestational age 6 weeks 0 days to 12 weeks 6 days, confirmed by ultrasound.
3. Willing and able to sign an informed consent.
4. Willing to comply with the study protocol.
5. Age at enrollment of 18 years or more.

Exclusion criteria

1. Allergy to doxycycline or any tetracycline
2. Evidence of current pelvic infection
3. Breastfeeding
4. Current or recent use (within the past 7 days) of any other antibiotic.
5. Prior cardiac valve surgery or cardiac valve replacement.
6. Active use of alcohol, heroin, or cocaine.

Post-enrollment Exclusion criteria

1) Abortion procedure not performed

Primary outcomes:
measure: Infection
timeFrame: 2 weeks
Secondary outcomes:
measure: nausea and emesis
timeFrame: 2 weeks
measure: compliance (completion of study medication)
timeFrame: 5 days
Other outcomes:
Locations:
city: Ho Chi Minh City
country: Vietnam
facility: Tu Du Hospital
Study officials:
affiliation: University of Pittsburgh
name: Matthew F Reeves, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tu Du Hospital, Ho Chi Minh City, Vietnam
name: Loi T Tran, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05801770: Discovering Factors in Head and Neck Cancer Patients' Clinical Study Experiences
Official title: An Observational Medical Trial Assessing Patterns in Experiences of Participants of Head and Neck Cancer Clinical Trials
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Head and Neck Cancer
Keywords: head and neck cancer
Lead sponsor: Power Life Sciences Inc.
Sponsor class: INDUSTRY
First posted: 2023-04-06
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who are actively considering involvement in an observational head and neck cancer clinical trial, but have not yet completed enrollment and registration.

Brief summary: Enrollment in clinical trials usually favors a particular demographic group. But there is limited research available to explain what study attributes affect the completion of these specific demographic groups.

This trial will evaluate the safety and efficacy of head and neck cancer treatments. The focus will be on tracking the rates of completion and withdrawal among these individuals.

It will also try to analyze data from the perspective of different demographic groups to check for recurring trends which might yield insights for the sake of future head and neck cancer studies.


Eligibility criteria: Inclusion Criteria:

* Patient is at least 18 years of age
* Patient is able and willing to comply with the treatment/follow-up schedule and requirements
* Patient must provide written informed consent

Exclusion Criteria:

* Participants who are vulnerable to any intervention
* Women who are pregnant, intend to become pregnant, or are lactating
* Inability to perform regular electronic reporting

Primary outcomes:
measure: Rate of patients who decide to enroll in a clinical study.
timeFrame: 3 months
measure: Number of study participants who remain in clinical trial until completion.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Power Life Sciences Inc.
name: Michael B Gill
role: STUDY_DIRECTOR
References:
citation: Kaanders JHAM, van den Bosch S, Kleijnen J. Comparison of Patients With Head and Neck Cancer in Randomized Clinical Trials and Clinical Practice: A Systematic Review. JAMA Otolaryngol Head Neck Surg. 2022 Jul 1;148(7):670-676. doi: 10.1001/jamaoto.2022.0890.
citation: Simon C, Caballero C. Quality Assurance and Improvement in Head and Neck Cancer Surgery: From Clinical Trials to National Healthcare Initiatives. Curr Treat Options Oncol. 2018 May 24;19(7):34. doi: 10.1007/s11864-018-0552-y.
citation: Argiris A, Karamouzis MV, Raben D, Ferris RL. Head and neck cancer. Lancet. 2008 May 17;371(9625):1695-709. doi: 10.1016/S0140-6736(08)60728-X.
Clinical trial NCT03967470: Bacteriotherapy to Improve Underarm Odor
Official title: Bacteriotherapy to Improve Underarm Odor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Bromhidrosis
Lead sponsor: University Ghent
Sponsor class: OTHER
First posted: 2019-05-30
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: two groups of 30 people, one month of bacterial spray use and the other month placebo.
Primary purpose: TREATMENT

Brief summary: The goal is to improve the underarm odor by changing the microbiome. The autochthonous bacterial community is replaced by a non-smelling microbiome, by daily application of bacteria in a spray.

Detailed description: Participants are recruited and selected based on their initial underarm odor and underarm microbiome. The participants use two sprays: one spray containing the bacteria, and the other nothing (placebo). Participants do not know which spray they have. They use one spray during one month, and meanwhile take samples of their underarm microbiome (for sequencing), volatome (for GC/MS analysis) and odor (for odor panel analysis). Samples are stored in the freezer and brought to the university after one month, when they receive the second spray. The bacterial spray contains bacteria that are correlated with good underarm odor.

Eligibility criteria: Inclusion Criteria:

* above average underarm malodor
* microbiome dominated with malodorous bacteria

Exclusion Criteria:

* not healthy
* microbiome with too high levels of Staphylococcus

Primary outcomes:
measure: Improved underarm odor
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: Ghent University
Study officials:
affiliation: University Ghent
name: Tom Van de Wiele, PhD
role: STUDY_CHAIR
References:
citation: Callewaert C, Lambert J, Van de Wiele T. Towards a bacterial treatment for armpit malodour. Exp Dermatol. 2017 May;26(5):388-391. doi: 10.1111/exd.13259. Epub 2017 Feb 2.
Clinical trial NCT00917670: Ultrastructural Changes of Trabeculectomy Specimens in Patients With Uveitic Secondary Glaucoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Uveitis
Secondary Glaucoma
Keywords: trabecular meshwork
electron microscopy
Lead sponsor: St. Franziskus Hospital
Sponsor class: OTHER
Collaborators: name: University of Erlangen-Nürnberg Medical School
First posted: 2009-06-10
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with uveitic secondary glaucoma in need of surgical intervention.

Brief summary: Ultrastructural analysis of trabeculectomy specimens of patients with uveitic secondary glaucoma.

To evaluate morphological changes and to compare to primary open angle glaucoma patients.


Eligibility criteria: Inclusion Criteria:

* secondary uveitic glaucoma
* IOP \> 24 mmhg with topical and/or systemic therapy
* need for surgical intervention to control IOP

Primary outcomes:
measure: morphological changes
timeFrame: after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: Department of Anatomy II at University of Erlangen, Germany
Study officials:
References:
Clinical trial NCT01474070: GAT-DCT-Discordance Due to Corneal Properties
Official title: Influence of Discordant Intraocular Eye Pressure Readings Taken by Dynamic Contour Tonometry and Goldmann Applanation Tonometry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glaucoma
Keywords: Glaucoma
Goldmann Tonometry
Dynamic Contour Tonometry
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2011-11-17
Enrollment: 112
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: glaucoma patients

Brief summary: IOP is measured with two devices (Dynamic Contour Tonometry (DCT) and Goldmann applanation tonometry (GAT)).

Detailed description: DCT reading will be compared to a corrected GAT reading by the formula of Elsheikh, Alhasso and Pye.

* Trial with medical device

Eligibility criteria: Inclusion criteria:

* clinical diagnosis of glaucoma

Exclusion criteria:

* other optic neuropathy other then glaucoma
* age\<18
* corneal surgery
* use of contact lenses

Primary outcomes:
measure: Intraocular pressure (IOP)
timeFrame: IOP is measured at the only study visit
Secondary outcomes:
measure: Demographical and clinical data
timeFrame: study visit V0
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Ophthalmic Clinic
state: ZH
Study officials:
affiliation: University Hospital Zurich, Ophthalmic Clinic
name: Christoph Kniestedt, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wachtl J, Toteberg-Harms M, Frimmel S, Roos M, Kniestedt C. Correlation Between Dynamic Contour Tonometry, Uncorrected and Corrected Goldmann Applanation Tonometry, and Stage of Glaucoma. JAMA Ophthalmol. 2017 Jun 1;135(6):601-608. doi: 10.1001/jamaophthalmol.2017.1012.
Clinical trial NCT01419470: Safety, Tolerability, Pharmacokinetics and Efficacy of YHD1044
Official title: Phase Ⅰ/Ⅱ Clinical Trial to Investigate the Safety, Tolerability, Pharmacokinetics and Efficacy of YHD1044 After Oral Administration in Premature Ejaculation Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Premature Ejaculation
Lead sponsor: Yuhan Corporation
Sponsor class: INDUSTRY
First posted: 2011-08-18
Enrollment: 24
Sex: MALE
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: safety and tolerability, pharmacokinetics/efficacy of an escalating, repeat doses of YHD1044 in premature ejaculation


Eligibility criteria: Inclusion Criteria:

* Patient is in a stable, monogamous sexual relationship with the same woman for at least 6 months and plans to maintain this relationship for the duration of the study
* History of premature ejaculation in the 6 months before study initiation
* History of intravaginal ejaculatory latency time (IELT) of \< = 2 minutes in at least half of events
* Premature Ejaculation Diagnostic Tool (PEDT) \> =11
* 6 domains of International Index of Erectile Function(IIEF) \>= 21
* Patient and partner must agree to attempt sexual intercourse at minimum intervals specified in the protocol
* Patient's partner must have a negative urine pregnancy test at time of screening

Exclusion Criteria:

* Medical history which affects ADME in the past 3 years
* Clinically significant and active disorder in ophthalmic system, gastro-intestine, cardiovascular, respiratory system, endocrine system, autoimmune system or malignant tumor,
* Subjects with clinically significant observations considered as unsuitable based on medical judgment in the physical examination and clinical laboratory tests or a medical history
* History of psychological disease
* Clinically significant allergic disease
* Hypersensitivity to TCA, SSRIs(Clomipramine, sertraline, fluoxetine, dapoxetine)
* Taken dapoxetine within 3 months
* Using other forms of therapy for treatment of PE (behavioral therapy or medications applied to the skin)
* Taken another investigational drug within 1 month
* History of drug abuse

Primary outcomes:
measure: Safety and tolerability
timeFrame: throughout the study up to day 28
Secondary outcomes:
measure: Efficacy(IELT)
timeFrame: 13days, 28days
measure: Cmax(Cmax,ss), Cmin,ss, AUCinf, AUCt, Tmax, CL/F
timeFrame: specified timepoints in the protocol
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung medical center
Study officials:
References: