louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06134596: Correlation of Clitoral Hood and Labia Minora Measurements and Female Genital Self Image Scale (FGSIS) Scores in Women
Official title: Correlation of Clitoral Hood and Labia Minora Measurements and Female Genital Self Image Scale (FGSIS) Scores in Women
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Genital Diseases, Female
Vulva
Keywords: Genital diseases, vulva
Lead sponsor: Bagcilar Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2023-11-18
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women who apply for outpatient gynecological control, are between the ages of 18-45, are sexually active, do not have additional endocrinological or malignant diseases, and are not pregnant or in menopause.

Brief summary: To evaluate the relationship between women's labium minora and clitoral hood measurements and Female Genital Self Image Scale (FGSIS) scores.

Detailed description: The main purpose of our study is to measure the labium minora and clitoral hood in women who apply to our clinic with gynecological disorders, evaluate them with FGSIS (Female Genital Self Image Scale) scores, and look at the relationship between genital area perception and labium minora and clitoral hood dimensions.

Eligibility criteria: Inclusion Criteria:

* Women who apply for outpatient gynecological control, are between the ages of 18-45, are sexually active, do not have additional endocrinological or malignant diseases, and are not pregnant or in menopause.

Exclusion Criteria:

* Those who are not sexually active, have varying degrees of pelvic organ prolapse or urinary incontinence, have a malignancy, or have an endocrinological disease

Primary outcomes:
measure: Correlation of genital measurement with genital perception
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bagcilar Teaching and Research Hospital
state: Bagcilar
Study officials:
affiliation: Bagcilar Training and Research Hospital
name: Evrim Ebru Kovalak, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Widschwendter A, Riedl D, Freidhager K, Abdel Azim S, Jerabek-Klestil S, D'Costa E, Fessler S, Ciresa-Konig A, Marth C, Bottcher B. Perception of Labial Size and Objective Measurements-Is There a Correlation? A Cross-Sectional Study in a Cohort Not Seeking Labiaplasty. J Sex Med. 2020 Mar;17(3):461-469. doi: 10.1016/j.jsxm.2019.11.272. Epub 2020 Jan 7.
Clinical trial NCT00409396: A Study to Determine Whether Urinary PGE-M Levels Correlate With Ulcerative Colitis Disease
Official title: Urinary PGE-M, A Metabolite of PGE2: A Novel Biomarker of Ulcerative Colitis Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ulcerative Colitis
Keywords: Ulcerative
Colitis
PGE-M
fecal calprotectin
disease biomarkers
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
Collaborators: name: Procter and Gamble
First posted: 2006-12-08
Enrollment: 35
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 determine whether urinary PGE-M levels correlate with Ulcerative Colitis Disease activity and to compare how well urinary PGEm correlates with other noninvasive biomarkers of disease activity such as CRP and fecal calprotectin.

Detailed description: The available clinical measures of ulcerative colitis activity can be overly influenced by functional symptoms. Placebo response rates in clinical trials are high. Several non-invasive biomarkers are currently available for assessing IBD disease activity including erythrocyte sedimentation rate, c-reactive protein and fecal calprotectin. Although these markers hold some promise, their performance is less than ideal. what is needed is a simple, non-invasive biologic measure of UC disease.

Cyclooxygenase-2 (COX-2) is involved in prostaglandin E2 (PGE2) synthesis and is expressed in epithelial inflammatory conditions and some cancers. We have developed an assay to quantify the major urinary metabolite of PGE2, PGE-M. PGE-M has been previously shown to be elevated in the urine of patients with advanced colorectal neoplasia relative to controls. We recently showed that PGEm was a sensitive and specific marker of Crohn's disease activity (Accepted for publication at DDW 2006).

Eligibility criteria: Inclusion Criteria:

* Outpatient male or female 18 years or older
* Confirmed diagnosis of ulcerative colitis
* Informed consent obtained
* Able to give blood, urine and stool samples
* Will undergo a diagnostic colonoscopy of part of routine Ulcerative Colitis care

Exclusion Criteria:

* Unable to give consent
* Crohn's disease
* Does not meet inclusion criteria
* Pregnant

Primary outcomes:
measure: Urine for PGEm Levels
timeFrame: Day of colonoscopy procedure
Secondary outcomes:
measure: Blood for CRP
timeFrame: Day 1
measure: Stool for fecal calprotectin
timeFrame: At least 2 days before colonoscopy procedure (prior to bowel prep)
measure: MAYO disease activity score
timeFrame: Day of colonoscopy procedure
measure: Routine colonoscopy for assessment of disease activity
timeFrame: 1-3 weeks after consent
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: David A. Schwartz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00768196: Prevalence of EED and Quality of Life Evaluated by Gastroesophageal Reflux Disease (GERD)-Q in Korean GERD Patients
Official title: Prevalence of EED and Quality of Life Evaluated by Gastroesophageal Reflux Disease (GERD)-Q in Korean GERD Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastroesophageal Reflux Disease
Keywords: GERD
Korea
typical symptom
quality of life
Naturalistic
epidemiological
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-10-07
Enrollment: 2000
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: general hospital sample

Brief summary: The purpose of this study is to asses the EED symptom prevalence in Koran GERD patients with typical reflux symptom and to evaluate quality of life with the scales including Gerd Q.


Eligibility criteria: Inclusion Criteria:

* GERD patients who have experienced heartburn or acid regurgitation during past 7 days
* GERD patients who have already undergone endoscopy before enrolment

Exclusion Criteria:

* Involvement in the planning and conduct of the programme
* The person who took the medicine such as PPI or H2RA during the last 7 days
* Severe systemic disease

Primary outcomes:
measure: The primary variable is the total rate of GERD patients who had EED symptom and effect on their quality of life.
Secondary outcomes:
measure: The secondary variable is the comparison of the EED symptom frequency in ERD and NERD patients.
Other outcomes:
Locations:
city: Cheonan
country: Korea, Republic of
facility: Research Site
state: Chungnam
city: Seoul
country: Korea, Republic of
facility: Research Site
state: Kyungkido
city: Sungnam
country: Korea, Republic of
facility: Research Site
state: Kyungkido
city: Suwon
country: Korea, Republic of
facility: Research Site
state: Kyungkido
Study officials:
affiliation: AstraZeneca Korea
name: Joon-Woo Bahn
role: STUDY_DIRECTOR
References:
Clinical trial NCT04126096: Negative Predictive Value and NIC of Beta-Lactam Antibiotics.
Official title: The Negative Predictive Value and Non-irritant Skin Testing Concentrations of Beta-Lactam Containing Antibiotics Other Than Penicillin.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Allergy
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2019-10-15
Enrollment: 747
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Skin testing
Primary purpose: DIAGNOSTIC

Brief summary: The researchers are trying to evaluate how much medication is required for allergy skin testing and to determine the likelihood that patients with a negative test truly don't have an allergy to the tested drug of skin testing to commonly used antibiotics.

Detailed description: This study will be a prospective study to accurately determine the negative predictive value of skin testing with beta lactam containing antibiotics other than penicillin .

It is hypothesized that the concentrations that should be used for beta lactams are actually much lower than previously recommended and that the higher incidence of identifiable beta lactam induced allergic reactions during anesthesia in the past may be due to irritation of the skin rather than a true allergic reaction (false positives).

Eligibility criteria: Inclusion Criteria:

* All adults \> or = to 18 y/o undergoing surgery

Exclusion Criteria:

* Minors under the age of 18 y/o, Adults unable to consent, or those Adults with previous allergic reaction history during previous surgeries.

Primary outcomes:
measure: Non-Irritant Concentrations to common beta lactam containing antibiotics other than penicillin
timeFrame: 1 Year
Secondary outcomes:
measure: Negative Predictive Value of Intradermal Skin Testing to commonly used beta lactam containing antibiotics other than penicillin
timeFrame: 1 Year
Other outcomes:
measure: Max Concentration used when skin testing to beta lactam containing antibiotics other than penicillin
timeFrame: 1 Year
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Alexei Gonzalez Estrada, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03294096: Clinical Validation of Nutritional Supplements Developed for Pancreaticobiliary Cancer Patients
Official title: Clinical Validation of Nutritional Supplements Developed for Pancreaticobiliary Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreaticobiliary Cancer
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2017-09-26
Enrollment: 15
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: Decreased bowel function and loss of appetite in patients who underwent pancreaticobiliary surgery contribute impaired nutritional status in postoperative period. It can also affect perioperative and oncologic outcomes negatively. Therefore it is important to improve nutritional status in postoperative period by supply tailor-made optimal diets. The investigators have developed customized postoperative diets and products for pancreaticobiliary cancer patients. The investigators expect that nutritional supplement for pancreaticobiliary patients will increase the food intake rate and contribute a improvement of perioperative outcomes and even oncologic outcomes.


Eligibility criteria: Inclusion Criteria:

* Adult (age more than 19)
* Pancreaticobiliary cancer patient who is scheduled pancreaticoduodenectomy or distal pancreatectomy
* Pancreatic cancer / Duodenal cancer / Distal bile duct cancer / Ampulla of Vater cancer

Exclusion Criteria:

* Patient who denied clinical trial
* Diabetes Mellitus(DM) patient with DM complication
* Hyperlipidemia patient with vascular co-morbidity
* Impaired renal function or renal failure (GFP\<70%)
* Poor nutritional status (PG-SGA grade C)

Primary outcomes:
measure: Food Intake Rate(%) for postoperative diet
timeFrame: Pre-operation
measure: Food Intake Rate(%) for postoperative diet
timeFrame: 1 day before discharging
measure: Food Intake Rate(%) for postoperative diet
timeFrame: 1 week after discharging (first outpatient follow up)
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Division of Hepatobiliary and Pancreatic Surgery, Department of Surgery, Yonsei University College of Medicine
Study officials:
References:
Clinical trial NCT00219596: Xalacom And Combination Of Unfixed Latanoprost And Timolol In Subjects With Open-Angle Glaucoma Or Ocular Hypertension
Official title: An 8-Week, Randomized, Open-Label, Parallel Group Study Comparing The Efficacy And Safety Of Xalacom With The Combination Of Unfixed Latanoprost And Timolol In Subjects With Open-Angle Glaucoma Or Ocular Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Glaucoma, Open Angle
Ocular Hypertension
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-22
Enrollment: 240
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: to compare efficacy and safety of Xalacom with the combination of unfixed Latanoprost and Timolol in subjects with open-angel glaucoma or ocular hypertension


Eligibility criteria: Inclusion Criteria:

* patients with open-angle glaucoma or ocular hypertension

Exclusion Criteria:

* closed/barely open anterior chamber angle or a history of acute angel closure glaucoma
* Ocular surgery within 3 months

Primary outcomes:
measure: To demonstrate that Xalacom is as effective as uFC latanoprost and timolol at reducing IOP in subjects with open-angel glaucoma or ocular hypertension
Secondary outcomes:
measure: To compare the proportion of subjects reaching specified IOP levels at Week 8 To evaluate the ocular and systemic AEs across all clinic visits
Other outcomes:
Locations:
city: Beijing
country: China
facility: Pfizer Investigational Site
state: Beijing
city: Beijing
country: China
facility: Pfizer Investigational Site
state: Beijing
city: Guangzhou
country: China
facility: Pfizer Investigational Site
state: Guangdong
city: Shanghai
country: China
facility: Pfizer Investigational Site
state: Shanghai
city: Xi?an
country: China
facility: Pfizer Investigational Site
state: Shanxi
city: Hangzhou
country: China
facility: Pfizer Investigational Site
state: Zhejiang
city: Hangzhou
country: China
facility: Pfizer Investigational Site
state: Zhejiang
city: Shanghai
country: China
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Zhao JL, Ge J, Li XX, Li YM, Sheng YH, Sun NX, Sun XH, Yao K, Zhong Z; Xalacom Study Group in China. Comparative efficacy and safety of the fixed versus unfixed combination of latanoprost and timolol in Chinese patients with open-angle glaucoma or ocular hypertension. BMC Ophthalmol. 2011 Aug 19;11:23. doi: 10.1186/1471-2415-11-23.
Clinical trial NCT02603796: 3D Imaging of Neonatal Faces
Official title: 3D Imaging of Neonatal Subjects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nose Deformities, Acquired
Keywords: 3-Dimensional
continuous positive airway pressure
nasal changes
Lead sponsor: Sharp HealthCare
Sponsor class: OTHER
Collaborators: name: Fisher and Paykel Healthcare
First posted: 2015-11-13
Enrollment: 18
Sex: ALL
Minimum age (years): 24
Maximum age (years): 42
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infants between 24 and 42 weeks corrected gestational age and admitted to Sharp Mary Birch NICU.

Brief summary: Facial scans of newborns will be performed before and after implementation of respiratory support devices such as nasal CPAP. 3D scanned images will be processed by Fisher \& Paykel Healthcare Limited. Images will be analyzed for changes or distortion in nasal structure.

Detailed description: Any newborns admitted to the neonatal intensive care unit at Sharp Mary Birch Hospital for Women and Newborns between 24-42 weeks CGA with parental informed consent are eligible. 3D scanned image will be obtained prior to implementation of nasal support devices and after nasal support devices. Fisher \& Paykel Healthcare Limited will analyze the 3D images and observations will be made for changes in nasal structure or distortion.

Eligibility criteria: Inclusion Criteria:

* Infants between 24 and 42 weeks corrected gestational age (inclusive) born at Sharp Mary Birch NICU,
* Signed informed consent form

Exclusion Criteria:

* Nasally intubated infants
* Infants with craniofacial abnormalities

Primary outcomes:
measure: Deformation changes in nares of preterm infants that require ncpap
timeFrame: Up to 6 months
Secondary outcomes:
Other outcomes:
measure: Gestational Age at time of CPAP
timeFrame: Up to 6 months
measure: Photograph of nose with scaled ruler
timeFrame: Up to 6 months
measure: Initial 3D scan
timeFrame: Up to 6 months
measure: Post ncpap 3D scan
timeFrame: Up to 6 months
measure: Total duration of ncpap days
timeFrame: Up to 6 months
Locations:
city: San Diego
country: United States
facility: Sharp Mary Birch Hospital for Women and Newborns
state: California
Study officials:
References:
Clinical trial NCT04155996: Data Acquisition Study in Inadequately Balanced Patients With Type 2 Diabetes Mellitus
Official title: Data Acquisition Study in Patients With Type 2 Diabetes Mellitus Who Are Inadequately Balanced With Oral Antidiabetic Agents and Basal Insulin
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Type2 Diabetes
Lead sponsor: ValoTec
Sponsor class: INDUSTRY
Collaborators: name: APHP
First posted: 2019-11-07
Enrollment: 10
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Type 2 Diabetic patients followed by french primary care or specialized centers.

Brief summary: The aim of this study is to collect continuous glucose monitoring (CGM) data, coupled with physical activity and everyday day life data. The purpose of this data collection is to help diabetologists to make recommendations to optimize type 2 diabetic patient management.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetic patient (T2D) with HbA1c ≥ 8% in the month prior to inclusion
* Patient is treated with oral anti-diabetics and / or analogous combined with basal insulin therapy (1 injection of slow-acting insulin in the evening)
* Age ≥ 35 years
* Diabetes diagnosis done over 1 year ago
* Patient accepting for 2 periods of 14 days spaced at most 3 days to wear a Freestyle glucose meter, a bracelet for measuring physical activity and to log daily life events in a dedicated smartphone application
* Patient is able to use a smartphone
* Patient is affiliated to the French health insurance system

Exclusion Criteria:

* Patient has Type 1 diabetes, diabetes secondary to pancreatic pathology, endocrinopathy or iatrogenic diabetes
* Patient is treated with a rapid-acting insulin
* Patient has had a severe hypoglycaemia in the year preceding inclusion
* Patent has a severe renal insufficiency (defined by a Glomerular Filtration Rate below 30 ml/min)
* Patient has had a myocardial infarction or other life-threatening medical condition in the last 6 months
* Patient has cognitive disorders or evolutionary psychiatric pathology
* Pregnant woman or woman likely to be pregnant, breastfeeding woman
* Patient plans to travel outside europe during the study
* Patient is participating to another clinical study

Primary outcomes:
measure: Data collection - Blood glucose levels
timeFrame: 28 days
measure: Data collection - Number of steps
timeFrame: 28 days
measure: Data collection - Sleep hours
timeFrame: 28 days
Secondary outcomes:
measure: Data collection - Daily meals information
timeFrame: 28 days
measure: Data collection - Physical activity information
timeFrame: 28 days
measure: Data collection - Medical treatment information
timeFrame: 28 days
Other outcomes:
Locations:
city: Paris
country: France
facility: GH Pitié Salpêtrière Charles Foix
state: Ile De France
Study officials:
affiliation: APHP
name: Marine HALBRON, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05770596: Vitamin C on Acute and Chronic Post Mastectomy Pain
Official title: Impact of Perioperative Vitamin C on Acute and Chronic Post Mastectomy Pain After Breast Cancer Surgery
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Vitamin C
Post-mastectomy Pain Syndrome
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2023-03-15
Enrollment: 204
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 prospective randomized double-blinded controlled study will be conducted to evaluate the effect of perioperative vitamin C on acute and chronic post mastectomy pain after breast cancer surgery

Detailed description: There is cumulative evidence that postoperative pain is closely associated with subsequent persistent pain lasting months. The International Association for the Study of Pain has defined chronic postsurgical pain (CPSP) as a pain that develops after surgical intervention and persists at least 2 months.

Eligibility criteria: Inclusion Criteria:

* Female patients aged ≥ 18years, with primary unilateral breast cancer and scheduled for lumpectomy, partial or total mastectomy with or without axillary lymph node dissection or modified radical mastectomy.

Exclusion Criteria:

- (1) Patients with renal stones or renal insufficiency, patients suffering from nausea and vomiting, gastroesophageal reflux or patients with chronic pain state.

(2) Intake of analgesic within 24 hours before surgery. (3) Patients unable to comply with the study protocol for any reason. (4) Contraindications to paravertebral block (PVB) such as allergy to local anesthetics, infection, or coagulopathy.

Primary outcomes:
measure: The incidence of chronic post mastectomy pain
timeFrame: 6 months after surgery
Secondary outcomes:
measure: The degree of acute postoperative pain
timeFrame: 48 hours postoperative
measure: The amount of total opioid dose in 48 hours after surgery
timeFrame: 48 hours postoperative
measure: The incidence of adverse effects
timeFrame: 48 hours postoperative
measure: The incidence of chronic pain at 9, 12 months after surgery
timeFrame: 12 months after surgery
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University
state: Gharbiya
Study officials:
References: