louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01643148: The Tetrad BMI, Leptin, Leptin/Adiponectin (L/A) Ratio and CA-15-3 is a Reliable Biomarker of Breast Cancer
Official title: Phase 1. Collect Samples of Breast Biopsy Patients Treated at the Hospital Radiology Service Maternal Perinatal Monica Pretelini
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Female Breast Carcinoma
Keywords: biomarker
BMI
breast cancer
CA-15-3
leptin
Lead sponsor: Materno-Perinatal Hospital of the State of Mexico
Sponsor class: OTHER
Collaborators: name: Universidad Autonoma del Estado de Mexico
First posted: 2012-07-18
Enrollment: 88
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Cross-sectional prospective study conducted at the Maternal-Perinatal Hospital "Mónica Pretelini" (HMPMP), State of Mexico Health Institute (ISEM), Toluca, Mexico, from January to October 2011.

Brief summary: Objective:

Evaluate body mass index (BMI), leptin, Leptin/adiponectin (L/A) ratio and cancer antigen (CA) 15-3 together as reliable biomarkers for breast cancer.

Patients:

Consecutive patients aged between 40 - 60 years, with breast disease and informed consent.

Interventions:

Patients' Anthropometric and laboratorial characteristics classified by BMI in the group of cancer and patients with benign breast disease as well as biochemical tests of leptin, adiponectin,CA 15-3, hemoglobin, glucose low-density lipoprotein cholesterol (LDLC), high-density lipoprotein cholesterol (HDLC) levels were obtained as well as a blood sample to analyze CA 15-3 levels with a electrochemiluminescence immunoassay.

Hypothesis:

Using together leptin, L/A ratio, CA 15-3 and BMI could offer a reliable approach to detect high risk women to develop breast cancer.

Detailed description: Serum levels of leptin, adiponectin and CA 15-3, as well as anthropometric and biochemical parameters were analyzed in 88 female patients attending mammography study. Predictive values of BMI, leptin, L/A ratio and CA 15-3 were determined with 95% confidence interval (CI).

Eligibility criteria: Inclusion Criteria:

* Female patients attending mammography, average age of the fourth and fifth decades.

Exclusion Criteria:

* Patients with hormonal therapy.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Autonomus University Of the State Of México
name: Jonnathan Guadalupe Santillán Benítez, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad Autonoma del Estado de Mexico
name: Leobardo Manuel Gómez Oliván, PhD
role: STUDY_DIRECTOR
affiliation: Autonomous University of the State of Mexico
name: Hugo Mendieta Zeron, PhD
role: STUDY_CHAIR
References:
citation: Santillan-Benitez JG, Mendieta-Zeron H, Gomez-Olivan LM, Torres-Juarez JJ, Gonzalez-Banales JM, Hernandez-Pena LV, Ordonez-Quiroz A. The tetrad BMI, leptin, leptin/adiponectin (L/A) ratio and CA 15-3 are reliable biomarkers of breast cancer. J Clin Lab Anal. 2013 Jan;27(1):12-20. doi: 10.1002/jcla.21555. Epub 2013 Jan 4.
Clinical trial NCT03303248: Evaluation of Web-based Transition Education to Enhance Transition Readiness
Official title: Evaluation of Web-based Transition Education to Enhance Transition Readiness and Health Service Utilization in Adolescents/Young Adults with Congenital Heart Disease
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Congenital Heart Disease
Transition
Pediatric Congenital Heart Disease
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: University of Nebraska
First posted: 2017-10-05
Enrollment: 180
Sex: ALL
Minimum age (years): 13
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The study looks to learn more about the helpfulness of web-based transition education and its effect on transition readiness and health service utilization in the adolescent and young adult congenital heart disease population.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with congenital heart disease
* Ages 13-25
* Routine outpatient cardiology follow-up visit

Exclusion Criteria:

* New patients to cardiology clinic
* Patients being evaluated for an acute medical problem
* Patients who do not speak English
* Severe neurocognitive impairment that precludes ability to complete the questionnaire

Primary outcomes:
measure: Change in transition readiness score, as measured by transition readiness survey
timeFrame: baseline, 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: C.S. Mott Children's Hospital
state: Michigan
Study officials:
affiliation: University of Michigan
name: Karen Uzark, PhD, CPNP
role: PRINCIPAL_INVESTIGATOR
References:
citation: Uzark K, Smith C, Donohue J, Yu S, Afton K, Norris M, Cotts T. Assessment of Transition Readiness in Adolescents and Young Adults with Heart Disease. J Pediatr. 2015 Dec;167(6):1233-8. doi: 10.1016/j.jpeds.2015.07.043. Epub 2015 Aug 19.
Clinical trial NCT06130748: Effectiveness of Two Mini-screws Supported Hyrax for Maxillary Expansion in Early Adulthood
Official title: Effectiveness of Two Mini-screws Supported Hyrax for Maxillary Expansion in Early Adulthood: A Randomized Control Trial.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Transverse Maxillary Deficiency
Keywords: maxillary expansion
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-11-14
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study aiming at evaluation of the Skeletal and Dento-alveolar expansion in adult patents using Two Mini-screws Supported Hyrax compared with untreated control group.

Detailed description: Methodology:

* Basic orthodontic record will be taken.
* impression with bands on upper first molars will be taken.
* Two eyelets will be soldered to the body of the hyrax appliance (size 10, Dentaurum, Germany).
* CBCT will be taken while patient wearing 1 mm thickness vacuum on the lower arch to dis-occlude both arches.
* Delivery, check the retention and fitness of the appliance.
* Cementation of the appliance using band cement(compomer).
* Using 3M contra-angle driver, the screws (Tomas screw size 10, Dentaurum, Germany) will be loaded and inserted.
* Activation of the appliance by opening it two turns immediately, followed by two turns everyday till cross bite correction or appearance of midline diastema.
* Closure of the device, and leave the appliance in-situ for five months as a retention.
* Post-expansion CBCT will be taken and continue fixed orthodontic treatment. Outcome: skeletal and dento-alveolar expansion will be evaluated

Eligibility criteria: Inclusion Criteria:

* Unilateral or bilateral Dental posterior cross-bite
* Skeletal Maxillary constriction
* Male and female patients.
* Chronological age (18-30 years).
* Mid-palatal suture maturation (Grade C,D ) according to F Angileri classification
* Good oral hygiene.
* No craniofacial anomalies or syndromes

Exclusion Criteria:

* Scissor-bite
* Orthodontically-treated
* functional cross bite due to premature occlusal contact
* patients with a syndrome
* cleft patients

Primary outcomes:
measure: Skeletal maxillary expansion To compare the amount of skeletal expansion pre and post expansion
timeFrame: the outcome will be assessed five months post-expansion
Secondary outcomes:
measure: Dento-alaveolar expansion
timeFrame: the outcome will be assessed five months post-expansion
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: faculty of dentistry, Cairo university
state: Giza
Study officials:
affiliation: Cairo University
name: abdullah mo ali al-thalabi, Msc candidate
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03785548: Utilization of the Mirror During Pelvic Exams
Official title: Utilization of the Mirror During Pelvic Exams: Does it Reduce Patient Vulnerability and Discomfort?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pelvic Exam
Lead sponsor: TriHealth Inc.
Sponsor class: OTHER
First posted: 2018-12-24
Enrollment: 147
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All women 18 years of age to 80, who undergo pelvic exam by a physician at Cincinnati Urogynecology Associates, TriHealth will be approached for recruitment.

Brief summary: This is a prospective cohort study to determine if using a birthing mirror during the patient's pelvic examination decreases patients's degree of vulnerability and discomfort.

Detailed description: In Obstetrics and Gynecology and its gynecologic subspecialties, the pelvic examination is routine practice for screening and diagnostic purposes. Nevertheless, due to their intimate nature, pelvic examinations may result in loss of control, embarrassment, discomfort and anxiety.

The mirror pelvic exam has been a proposed technique to decrease patient anxiety and improve comfort during an already uncomfortable examination. However, little research has focused on this modality to date.

The purpose of this study is to investigate whether the mirror pelvic exam decreases the level of vulnerability and discomfort experienced during the pelvic examination.

Eligibility criteria: Inclusion Criteria:

* New patients undergoing a pelvic exam performed by a physician at Cincinnati Urogynecology Associates, TriHealth

Exclusion Criteria:

* Existing patients
* Unwillingness to participate in the study
* Physical or mental impairment that would affect the subject's ability to visualize the mirror during examination or to complete questionnaires
* Inability to understand English

Primary outcomes:
measure: Group Difference in Visual Analog Scale (VAS) on Level of Vulnerability
timeFrame: 30 minutes after the pelvic exam
measure: Group Difference in Visual Analog Scale (VAS) on Level of Pain/Discomfort
timeFrame: 30 minutes after the pelvic exam
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Urogynecology Associates
state: Ohio
Study officials:
affiliation: TriHealth - Cincinnati Urogynecology Associates
name: Rachel Pauls, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tam T, Crisp CC, Hill AM, Aldrich E, Ghodsi V, Yook E, Yeung J, Pauls RN. Utilization of a Mirror During Pelvic Examinations: Does it Improve the Patient's Experience? Female Pelvic Med Reconstr Surg. 2021 Mar 1;27(3):208-213. doi: 10.1097/SPV.0000000000000975.
Clinical trial NCT02385448: Comparing the Use of Dienogest and Combined Oral Contraceptive Pills (Microgynon) to Reduce the Risk of Recurrence of Endometriotic Cyst After Conservative Surgery
Official title: A Prospective, Randomized Controlled Trial Comparing the Use of Dienogest and Combined Oral Contraceptive Pills (Microgynon) to Reduce the Risk of Recurrence of Endometriotic Cyst After Conservative Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Endometriosis
Keywords: dienogest
combined oral contraceptive pills
endometriosis
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2015-03-11
Enrollment: 144
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 51
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the study is to compare the recurrence of endometriotic cyst in patients taking Dienogest or Microgynon after conservative surgery.


Eligibility criteria: Inclusion Criteria:

* Good general health
* Older than the age of legal consent (i.e. 18 years old)
* Sonographic diagnosis of ovarian endometrioma with diameter at least 4cm on 2 separate scans at least 6 weeks apart
* No contraindication to use of progesterone or combined oral contraceptive pills
* Not attempting to conceive either at the time of study entry or for at least 2 years after surgery
* Willing and able to participate after the study has been explained

Exclusion Criteria:

* Operative findings not suggestive of endometriotic cyst
* Contraindications to progestogens or oral contraceptive pills
* Unwillingness to tolerate menstrual irregularity
* Planning pregnancy within 2 years of study
* Cannot understand English, Cantonese or Putonghua

Primary outcomes:
measure: Recurrence of ovarian endometrioma
timeFrame: 2 years
measure: Recurrence of ovarian endometrioma
timeFrame: 2 years
Secondary outcomes:
measure: Side effects
timeFrame: 2 years
measure: Symptoms of endometriosis
timeFrame: 2 years
measure: Need for additional analgesics
timeFrame: 2 years
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
Study officials:
affiliation: The University of Hong Kong, Queen Mary Hospital
name: Jennifer K.Y. Ko, MBBS, MRCOG
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02554448: Detection of CTCs in Stage III Rectal Cancer Patients Undergoing Neoadjuvant Therapy
Official title: Detection of CTCs in Stage III Rectal Cancer Patients Undergoing Neoadjuvant Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rectal Neoplasms
Circulating Tumor Cells
Keywords: Circulating Tumor Cells
rectal Neoplasms
neoadjuvant otherapy
Lead sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2015-09-18
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The purpose of this study is to evaluate the value of dynamic change in detecting CTCs in peripheral blood from stage III rectal cancer patients undergoing neoadjuvant Folfox treatment and chemoradiotherapy,before and after surgery.

Detailed description: Circulating tumor cells (CTCs) have the potential to provide a surrogate for'real-time biopsy' of tumor biological activity. Enumeration of CTCs in rectal cancer patients could play an important role in diagnosis, predicting the risk for tumor recurrence and effectiveness of neoadjuvant therapy.

The investigators choose several timepoints to detect the dynamic change of CTCs,1 day before the 1st ,3rd and 5th(if the patient needs before surgery) neoadjuvant therapy course,1 day before and 7days ,3 month,6 month after surgery. Approximately 7.5-mL ethylene diamine tetraacetic acid(EDTA)-blood was drawn by vein puncture from patients with rectal cancer . Briefly, the number of CTCs will be count by the cellsearch system , recorded and analysed by the investigator.

Eligibility criteria: Inclusion Criteria:

1. Age: \>18 years old.
2. Diagnosis of stage III rectal cancer based on histology.
3. Will receive neoadjuvant treatment using Folfox or chemoradiotherapy .
4. Life expectancy: Greater than 3 months.
5. Patients have no severe inflammation, such as vasculitis.
6. Ability to understand the study protocol and a willingness to sign a written informed consent document

Exclusion Criteria:

1. Patients with other primary tumor except rectal cancer.
2. History of coagulation disorders or anemia.

Primary outcomes:
measure: The number of Circulating Tumor Cells (CTCs)
timeFrame: 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: GuangZhou
country: China
facility: The Sixth Affiliate Hospital of Sun Yat-Sen University
state: Guangdong
Study officials:
affiliation: Sixth Affiliated Hospital, Sun Yat-sen University
name: Yanxin Luo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03279848: Stratification of Stroke Rehabilitation: 5-year Profiles of Functional Outcomes
Official title: Stratification of Stroke Rehabilitation: 5-year Profiles of Functional Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke Rehabilitation
Lead sponsor: Tai Po Hospital
Sponsor class: OTHER_GOV
First posted: 2017-09-12
Enrollment: 2722
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with principal diagnosis of cerebrovascular accident, stroke, or hemiplegia.

Brief summary: Objective: To make use of admission Modified Functional Ambulation Category (MFAC) as a stratification tool to reveal profiles of functional outcomes of patients with stroke in inpatient rehabilitation.

Design: This was a retrospective, descriptive study of the demographic, functional outcomes of patients with stroke in an inpatient rehabilitation centre. A total of 2,722 patients completed a stroke rehabilitation program from 2011 to 2015 were recruited.

Detailed description: Objective: To make use of admission Modified Functional Ambulation Category (MFAC) as a stratification tool to reveal profiles of functional outcomes of patients with stroke in inpatient rehabilitation.

Design: This was a retrospective, descriptive study of the demographic, functional outcomes of patients with stroke in an inpatient rehabilitation centre. A total of 2,722 patients completed a stroke rehabilitation program from 2011 to 2015 were recruited. The patients were divided into seven groups according to their admission Modified Functional Ambulation Category (MFAC). The between-group difference in length of stay (LOS), functional outcomes at admission and discharge including Modified Rivermead Mobility Index (MRMI) and Modified Barthel Index (MBI) as well as MRMI gain, MRMI efficiency, MBI gain and MBI efficiency were analyzed.

Eligibility criteria: Inclusion Criteria:

* Patients with principal diagnosis of cerebrovascular accident, stroke, or hemiplegia and has received and completed stroke rehabilitation program in a hospital in Hong Kong between the periods of 1st January 2011 to 31st December 2015.

Exclusion Criteria:

* Patients with principal diagnosis of cerebrovascular accident, stroke, or hemiplegia and has received but cannot completed stroke rehabilitation program in a hospital in Hong Kong between the periods of 1st January 2011 to 31st December 2015.

Primary outcomes:
measure: Change in Modified Rivermead Mobility Index (MRMI)
timeFrame: baseline and 1 month
Secondary outcomes:
measure: Change in Modified Barthel Index (MBI) Gain
timeFrame: baseline and 1 month
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03205748: Evaluation of Different Etiologies of Obscure Ascites
Official title: Evaluation of Different Etiologies of Obscure Ascites: Clinical, Laboratory, and Laparoscopic Study.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ascites
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-07-02
Enrollment: 50
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: All patients will be recruited from Departments of Internal Medicine, Assiut university tertiary hospital.

Brief summary: Ascites refers to fluid that accumulates within the peritoneal cavity. Although ascites is most commonly observed in patients with cirrhosis and resulting portal hypertension (approximately 85% of cases), 7% to 10% of patients with ascites develop secondary to a malignancy


Eligibility criteria: Inclusion Criteria:

* Patients with ascites
* serum ascites albumin gradient \>1.1.

Exclusion Criteria:

* ascitic fluid serum ascites albumin gradient \<1.1.
* Haemorrgaic ascites;
* chylous ascites

Primary outcomes:
measure: The percentage of patients with malignant ascites
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut Faculty of Medicine
Study officials:
References:
Clinical trial NCT05305248: Sedation With Remimazolam During Spinal Anesthesia
Official title: Comparison of Sedation With Intravenous Remimazolam and Dexmedetomidine During Spinal Anesthesia : Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sedation
Spinal Anesthesia
Lead sponsor: Gangnam Severance Hospital
Sponsor class: OTHER
First posted: 2022-03-31
Enrollment: 62
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Remimazolam is a benzodiazepine-binding site antagonist of the GABA receptor, metabolized by esterases, and exhibits a stable context-sensitive half-life of 6-7 minutes. Remimazolam has a high clearance rate and a small volume of distribution in the pharmacokinetic model. The US FDA has approved sedation for surgery. Although there have been studies on the use of remimazolam as a sedative for procedures such as endoscopy, there have been no reports of the use of remimazolam in spinal anesthesia. The purpose of this study is to compare and analyze the hemodynamics and recovery profile of patients undergoing surgery under spinal anesthesia by maintaining sedation with dexmedetomidine or remimazolam.


Eligibility criteria: Inclusion Criteria:

1. Severe cardiovascular or respiratory disease
2. Contraindication to spinal anesthesia
3. Heart block
4. Previous hepatectomy or liver transplant
5. Patients with moderate or more hepatic impairment (AST/ALT is more than 2.5 times the upper limit of normal)
6. Estimated glomerular filtration rate \< 30 mL/min/1.73m2
7. Acute narrow angle glaucoma
8. Myasthesia gravis
9. Known allergy to the drugs included in the study

Exclusion Criteria:

1. Patients 19 years of age or older who are expected to elective orthopedic surgery under spinal anaesthesia
2. ASA PS 1-3

Primary outcomes:
measure: MOAA/S score
timeFrame: up to 30 minutes after PACU arrival
Secondary outcomes:
measure: Sedation induction time Sedation induction time
timeFrame: up to 5 minutes after initation of sedative drugs
measure: Differences in basic vital signs between the two groups
timeFrame: Baseline
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
Study officials:
References: