louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05100264: Effect of Acidic Vaginal pH on the Efficacy of Dinoprostone for Labor Induction
Official title: Effect of Acidic Vaginal pH on the Efficacy of Dinoprostone (PGE2) Vaginal Tablet for Labor Induction in Full Term Pregnant Women: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Labor, Induced
Induced; Birth
Keywords: labor induction
dinoprostone
vaginal pH
Lead sponsor: Alexandra Hospital, Athens, Greece
Sponsor class: OTHER
Collaborators: name: National and Kapodistrian University of Athens
First posted: 2021-10-29
Enrollment: 230
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Acidification of vaginal pH has been proposed as a potential factor that could help increase the efficacy of vaginal prostaglandins in labor induction. The aim of the present randomized controlled trial is to evaluate the impact of an acidic vaginal pH on the progress of labor induction with dinoprostone (Prostaglandin E2 - PGE2) vaginal tablet.


Eligibility criteria: Inclusion criteria

* Singleton pregnancy
* Full term (\>37 weeks)
* Cephalic presentation
* Reactive NST (nonstress test)
* Absence of spontaneous uterine contractions
* No contraindications to vaginal delivery

Exclusion criteria

* Multifetal pregnancy
* Fetal malpresentation
* Preterm delivery (\<37 weeks)
* Advanced maternal age (\>40 years)
* Bishop score \> 7
* Fetal macrosomia ( \>4500 gr)
* Non reassuring NST (nonstress test)
* Suspected chorioamnionitis
* Previous cesarean delivery or other uterine surgery

Primary outcomes:
measure: Interval from induction to delivery
timeFrame: 36 hours
Secondary outcomes:
measure: Interval from induction to active labor
timeFrame: 36 hours
measure: Interval from induction to second stage of labor
timeFrame: 36 hours
measure: Failure of induction of labor
timeFrame: 36 hours
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Alexandra General Hospital
Study officials:
affiliation: Alexandra General Hospital
name: Georgios Daskalakis
role: STUDY_DIRECTOR
References:
Clinical trial NCT00728364: Anderson-Fabry Disease in Chronic Kidney Disease Patients Not on Renal Replacement Therapy
Official title: A Case Finding Study for Anderson-Fabry Disease Among Patients With Chronic Kidney Disease Not on Renal Replacement Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Focus of Study: Prevalence of Fabry Disease in CKD Population
Keywords: Anderson Fabry disease
chronic kidney disease
prevalence
Lead sponsor: Klinikum Wels-Grieskirchen
Sponsor class: OTHER
Collaborators: name: Genzyme, a Sanofi Company
First posted: 2008-08-05
Enrollment: 4353
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic kidney disease KDOQI stage 1-5 attending outpatient nephrology clinics in Austria and willing to participate

Brief summary: Anderson-Fabry disease is a rare X-linked lysosomal storage disorder due to the deficiency of alfa-galactosidase A (AGAL). The subsequent accumulation of glycosphingolipids may lead to to cardiac, renal, and central nervous system impairment as well as premature death. Recently published studies suggest that the true incidence of the disease may be underestimated in certain risk groups, e.g. in patients with chronic kidney disease (CKD).

Therefore, the investigators initiated a multicenter case-finding study in Austria by screening patients with chronic kidney disease not yet on renal replacement therapy. Molecular isoforms of globotriaosylceramide (Gb3), characterized by different chain lengths of their N-acyl residues, will be determined in a urine sample. Characteristic parameters, including the ratio of C24/C18 isoforms will be used for identifying patients liable to have the disease. A positive result will be confirmed by biochemical and genetic testing.

A sample size of 5.000 chronic kidney disease patients is envisaged allowing for detection of 1 to 25 patients with Anderson-Fabry disease.


Eligibility criteria: Inclusion Criteria:

* Chronic kidney disease KDOQI stage 1-5
* Informed consent

Exclusion Criteria:

* Patients already on renal replacement therapy
* Not willing to participate

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Wels
country: Austria
facility: Klinikum Wels-Grieskirchen
state: Upper Austria
Study officials:
affiliation: Klinikum Wels-Grieskirchen
name: Manfred Wallner, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kotanko P, Kramar R, Devrnja D, Paschke E, Voigtlander T, Auinger M, Pagliardini S, Spada M, Demmelbauer K, Lorenz M, Hauser AC, Kofler HJ, Lhotta K, Neyer U, Pronai W, Wallner M, Wieser C, Wiesholzer M, Zodl H, Fodinger M, Sunder-Plassmann G. Results of a nationwide screening for Anderson-Fabry disease among dialysis patients. J Am Soc Nephrol. 2004 May;15(5):1323-9. doi: 10.1097/01.asn.0000124671.61963.1e.
Clinical trial NCT03319264: Sarcopenia in Axial and Peripheral Spondyloarthropathies
Official title: Sarcopenia in Axial and Peripheral Spondyloarthropathies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spondylarthropathy
Sarcopenia
Keywords: Spondylarthropathy
Sarcopenia
lean mass
fat mass
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2017-10-24
Enrollment: 106
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: SCREENING

Brief summary: Spondylarthropathies (SpA) are among the most common chronic inflammatory rheumatisms in adults, responsible for a muscular loss or sarcopenia which can be very disabling, not much documented in the literature, and not yet studied in France. In addition, sarcopenia is associated with decreased physical activity and increased risk of falls and fractures. A better characterization of the determinants of this muscular loss will allow to better detect and take care of it.

The aim is to conduct the first French study on the prevalence and severity of sarcopenia in patients with spondyloarthropathies and to study the variables that may be associated with it. Finally, we propose to evaluate obesity related to sarcopenia in these patients and compare them to cases matched for age and sex (from OFELY / STRAMBO cohorts, Lyon, FRANCE).

This is a prospective interventional and monocentric study with minimal risks and constraints: patients will be included for one day for an evaluation of their sarcopenia by measuring their muscle strength, physical performance and body composition and recording of their socio-demographic and disease characteristics.


Eligibility criteria: Inclusion Criteria:

* Men and women, 18 to 80 years old
* Hospitalized or attending the rheumatology department for spondyloarthopathy.

Exclusion Criteria:

* no signed consent
* Immobilization for a period of more than 15 days during the last 3 months
* pregnant or breastfeeding woman
* Not affiliated to the national healthcare insurance
* difficulty in understanding French
* psychiatric disorder

Primary outcomes:
measure: Muscular strength
timeFrame: At day 1
measure: Walking speed
timeFrame: At day 1
measure: Muscular mass
timeFrame: Up to 4 month after inclusion
Secondary outcomes:
measure: Alcohol consumption
timeFrame: At day 1
measure: Tobacco consumption
timeFrame: At day 1
measure: Time of sport practice per month
timeFrame: At day 1
measure: Physical activity rate in work
timeFrame: At day 1
measure: Average walking time in a week
timeFrame: At day 1
measure: Score at the SARQOL questionnaire
timeFrame: At day 1
Other outcomes:
Locations:
city: Lyon
country: France
facility: Service de Rhumatologie - Hôpital Edouard Herriot
Study officials:
References:
Clinical trial NCT05886764: Novel Outreach Methods to Increase Enrollment to Early Phase Clinical Trials
Official title: Randomized Trial of Recruitment Strategies for Early Phase Therapeutic Cancer Trials
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer
Malignancy
Malignant Neoplasm
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: Stand Up To Cancer
First posted: 2023-06-02
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This trial will study different outreach methods to assess impact on enrollment of underrepresented minorities (specifically African Americans) to early phase cancer clinical treatment trials. Both patients and providers (those seeing enrolled patients) will be enrolled and receive the study interventions or no intervention (control arm).


Eligibility criteria: Inclusion Criteria for Patient Subjects:

* Aged 18 years or older
* Self-described African American race (patients who self-describe as "more than one race" will be included)
* Scheduled for new or consult oncology appointment at the study site
* Scheduled for return outpatient oncology appointment at the study site with a biopsy or radiology encounter within 2 weeks prior to provider visit.

  * for prostate cancer patients: 2 or more increasing prostate specific antigen (PSA) values i the 6 months prior to visit
* other patient identified by research team as potentially having a change in treatment prior to next outpatient oncology appointment at the study site

Inclusion Criteria for Provider Subjects:

* oncology provider at study site scheduled to see patients meeting criteria above

Exclusion Criteria for Patient Subjects:

* Estimated glomerular filtration rate (GFR) less than 30 ml/min/1.73m2 documented within last 2 months and without documented resolutions
* Bilirubin greater than 3.0 ng/dl documented within last 2 months and without documented resolution
* Initiated new anti-cancer therapy within last 2 months
* Evaluated for possible enrollment/randomization in the last 2 months
* Prior enrollment/randomization on this recruitment trial

Primary outcomes:
measure: Percentage of patients that enroll to early phase cancer treatment clinical trials.
timeFrame: within 2 months of randomization
Secondary outcomes:
measure: Number of successfully completed outreach efforts
timeFrame: after 30 participants are enrolled to each of arms 2 and 3
measure: Percentage of patients that enroll to early phase cancer treatment clinical trials post intervention.
timeFrame: 2 years from randomization
measure: Percent change in number of African Americans that enroll to cancer clinical trials
timeFrame: 2 years after study start
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago Medicine Comprehensive Cancer Center
state: Illinois
Study officials:
affiliation: University of Chicago
name: Walter Stadler
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00663390: Safety Dermatological Evaluation: Acceptability With Gynecological Follow up - Dermacyd Delicata Pocket BR
Official title: Monocentric Study, Phase III, for Safety Dermatological Evaluation: Acceptability With Gynecological Follow up - Dermacyd Delicata Pocket BR
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hygiene
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-04-22
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to demonstrate the safety of the gynecological formulation in normal and usual usage condition of Dermacyd Delicata Pocket.


Eligibility criteria: Inclusion Criteria:

* Integral skin test in the region;

Exclusion Criteria:

* Lactation or gestational risk or gestation;
* Use of Anti-inflammatory or immunosuppression drugs 1 month before the study;
* Topical medication use at the region to be treated;
* Cutaneous disease or active gynecological disease which may interfere in study results;
* Personal history of allergic disease at the area to be treated;
* Allergic or atopic history;

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Adverse events and their intensity and their association with the treatment.
timeFrame: 21 days
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Sanofi-aventis
Study officials:
affiliation: Sanofi-aventis administrative office Brazil
name: Jaderson Lima
role: STUDY_DIRECTOR
References:
Clinical trial NCT02280590: Comparison of the Efficacy and Safety of Cresnon® and Crestor® in Patients With Hyperlipidemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hyperlipidemia
Lead sponsor: Dong-A ST Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2014-10-31
Enrollment: 223
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparison of the efficacy and safety of Cresnon® and Crestor® in patients with hyperlipidemia

- 8-week, active-controlled, open-label, randomized, parallelgroup, fixed-dose, noninferiority, multicenter, phase 4 design


Eligibility criteria: Inclusion Criteria:

* Age ≥ 20
* Persons who have not reached LDL-C targeted level in accordance with the treatment guidelines for dyslipidemia released by Korean Society of Lipidology and Atherosclerosis

Primary outcomes:
measure: The percent change in LDL-C
timeFrame: After taken medication for 8 weeks
Secondary outcomes:
measure: The percent change in total cholesterol, Triglyceride, HDL-C, non-HDL-C, and non-HDL-C/HDL-C
timeFrame: After taken medication for 8 weeks
measure: The proportion of subjects reaching LDL-C targeted level in accordance with the treatment guidelines for dyslipidemia released by Korean Society of Lipidology and Atherosclerosis
timeFrame: After taken medication for 8 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT00898690: Gene Expression in Predicting Response to Paclitaxel in Patients With Breast Cancer
Official title: Determination Of FEZ1/LZTS1 Expression As A Predictor Of Response To Taxol
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Keywords: stage I breast cancer
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
stage IV breast cancer
recurrent breast cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-05-12
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: RATIONALE: DNA analysis of tumor tissue may help doctors predict how patients who receive paclitaxel will respond to treatment.

PURPOSE: This laboratory study is evaluating gene expression in predicting response to paclitaxel in patients with breast cancer.

Detailed description: OBJECTIVES:

* Determine whether loss of function of the FEZ1/LZTS1 gene is a predictor of response in patients with breast cancer treated with paclitaxel.

OUTLINE: This is a single-blind study.

Tumor tissue is analyzed for FEZ1/LZTS1 gene expression by immunohistochemistry using an antibody for the gene. Tumor expression of the gene is characterized by immunohistochemistry and scored by intensity of staining, percent of cell staining, and staining index. Tumor tissue is also analyzed for FEZ1/LZTS1 gene disruption by reverse transcriptase-polymerase chain reaction and direct sequencing.

PROJECTED ACCRUAL: Approximately 120 patients will be accrued for this study.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Diagnosis of breast cancer
* Measurable disease

  * Metastatic disease identified by imaging studies OR a primary disease site that will be treated in a neoadjuvant protocol
  * Lesions ≥ 10 mm by spiral CT scan
* Tumor tissue from the primary or metastatic site available for analysis by immunohistochemistry
* Previously treated OR planning to undergo treatment with paclitaxel\* NOTE: \*Concurrent enrollment on ECOG-2100 allowed
* Hormone receptor status:

  * Not specified

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics

Primary outcomes:
measure: Evaluation of the association between tumor expression of FEZ1/LZTS1 gene and response to paclitaxel
Secondary outcomes:
measure: Utility of FEZ1/LZTS1 gene expression in predicting the full 4-level response pattern (complete response, partial response, stable disease, progressive disease)
Other outcomes:
Locations:
Study officials:
affiliation: Sidney Kimmel Cancer Center at Thomas Jefferson University
name: Carlo M. Croce, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06092190: Effect of Spasticity on Tibial Nerve Entrapment
Official title: Impact of Lower Limb Spasticity on Tibial Nerve Entrapment in Patients With Stroke
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Neuropathy
Stroke
Lead sponsor: October 6 University
Sponsor class: OTHER
First posted: 2023-10-23
Enrollment: 100
Sex: ALL
Minimum age (years): 55
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: A hundred patients were selected from the Out-Patient Clinics of Neurology in Kasr Al- Aini Hospitals and Out-Patient Clinic of Neurology, Faculty of Physical Therapy, Cairo University.

Brief summary: Stroke is the most common cause of mortality and is one of the most common causes of morbidity in the world. Polyneuropathies and entrapment neuropathies are known as the complications of stroke


Eligibility criteria: Inclusion Criteria:

* 1- A hundred patients with hemiplegia /paresis subsequent to a stroke as diagnosed by CT or MRI.

  2- A hundred patients from both sexes, their ages ranged from (55-65) years. 3- Body weight of patients was ranged from(55 -95 kg) ,while their height was from (151-185 cm) and BMI was ranged from (20-30 kg/m2).

  4- Duration of illness (6 - 9 months post stroke). 5- Patients have spasticity ranging from grade 1 to grade 3 according to modified Ashworth scale 6- Patients were medically stable

Exclusion Criteria:

* 1- Patients with lumbosacral sciatica that could mimic TTS or interfere with its evaluation 2- Patients with tibial neuropathy, significant polyneuropathy, or marked orthopedic abnormalities; 3- Patients with contractures 4- Patients with psychological disturbance or seizures 5- Systemic diseases known to cause TTS, such as diabetes mellitus, hypothyroidism, rheumatoid arthritis, or chronic renal failure;

Primary outcomes:
measure: Electrodiagnostic testing
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: October 6 University
Study officials:
affiliation: October 6 University
name: Hosam Magdy Metwally Abd Alhamid, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Al Ryada University for science and technology
name: Ahmed Magdy Alshimy, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05308290: Optimizing Cerebral Autoregulation During Surgery
Official title: Optimizing Cerebral Autoregulation During Surgery
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hip Fractures
Hip Arthropathy
Surgery
Delirium
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2022-04-04
Enrollment: 27
Sex: ALL
Minimum age (years): 60
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to conduct a pilot trial to determine the feasibility, safety, and potential efficacy of targeting mean arterial blood pressure (MAP) within the limits of cerebral autoregulation during surgery compared with usual care.


Eligibility criteria: Inclusion Criteria:

* planned hip or knee surgery (either for fracture or elective) or lung surgery
* age ≥60
* ambulatory at baseline
* expected duration of surgery \> 90 minutes

Exclusion Criteria:

* Planned concurrent surgery
* Allergy to adhesive tape
* Short Blessed Test score \>20
* Clinical diagnosis of dementia
* Opinion of either the anesthesiologist or surgeon that the patient is not appropriate.

Primary outcomes:
measure: Mean arterial pressure outside limits of cerebral autoregulation
timeFrame: Intraoperative, up to 5 hours
measure: Estimated Blood Loss
timeFrame: Intraoperative, up to 5 hours
measure: Incidence of new Myocardial Infarction after surgery
timeFrame: In the hospital after surgery, up to 1 week
measure: Incidence of new Stroke after surgery
timeFrame: In the hospital after surgery, up to 1 week
Secondary outcomes:
measure: Number of participants that develop delirium after surgery
timeFrame: In the hospital during the first 3 days after surgery
measure: Change in general Cognitive Function as assessed by the Short Blessed Test
timeFrame: Approximately 60, 180, and 365 Days after Surgery
measure: Change in Executive Cognitive Function as assessed by the Oral Trail Making Test
timeFrame: Approximately 60, 180, and 365 Days after Surgery
measure: Dementia Screening as assessed by the AD8 test
timeFrame: 365 Days after Surgery
measure: Change in general overall health and Disability as assessed by the WHO Disability Assessment Schedule 2.0
timeFrame: Approximately 60, 180, and 365 Days after Surgery
measure: Change in General function as assessed by the Instrumental Activities of Daily Living questionnaire
timeFrame: Approximately 60, 180, and 365 Days after Surgery
measure: Change in ability to Ambulate without human assistance
timeFrame: Approximately 60, 180, and 365 Days after Surgery
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: The Johns Hopkins University
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Charles Brown, MD
role: PRINCIPAL_INVESTIGATOR
References: