louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03064412: Effect of Pregnancy on Androgenic Steroids in Different Genetic Panels
Official title: Effect of Pregnancy on Androgenic Steroids in Different Genetic Panels
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sex Steroids
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
First posted: 2017-02-27
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Androgens are important sex steroids in women. Androgens influence protein synthesis and muscle growth, are involved in maturation of the reproductive organs, have a fat reducing effect , have a negative effect on the serum lipid profile, and may also increase insulin resistance and coagulation activity. The role of androgens in women is not clear. This study is aimed at learning about the amount of androgen and its actions in pregnant women. This study is also looking to see if there are specific patient factors (such as genetics) that change the amount of androgen and its activity.

Detailed description: There is a lot of information about the main female sex hormones such as estrogens and progesterones (the main female sex hormones and the most important in menstrual , reproductive cycles and pregnancy) . However there is little information about androgens in pregnant women. It is known that certain illnesses, chemicals and dietary products might change the amount of androgen and its actions, which could affect the mother and her baby. It is also known that there are differences between the androgen levels in different people, and in different ethnic groups. These differences are mostly due to genetic factors. The goal of this study is to learn about the androgen levels in healthy pregnant women and if genetic or clinical factors (for example age, trimester of pregnancy, parity, ethnicity, etc.) play a role in changing the androgen amount and action, throughout pregnancy and after delivery.

Eligibility criteria: Inclusion Criteria:

* healthy women without drug treatment, in the age range of 18-40 years

Exclusion Criteria:

* Any chronic disease such as Hypertension or Diabetes Mellitus
* Positive for HIV, hepatitis, Syphilis
* Abnormal laboratory test results (e.g. abnormal TSH, glucose, creatinine, HIV, HBV, VDRL)
* PCOS
* Ongoing hormonal treatment-e.g. progesterone, estrogen or other
* Smoking cigarettes, alcohol, regular substance use
* Confirmed or suspected abuse of drugs
* Chronic prescription drugs
* Pre-existing diabetes or GDM in last pregnancy

Primary outcomes:
measure: Changes in sex steroids
timeFrame: 1st trimester (1-12 weeks gestation), 2nd trimester (13-28 weeks gestation), 3rd trimester (28-40 weeks gestation), 6 weeks post-partum
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Unity Health Toronto
name: Howard Berger, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00782912: Postpartum Anemia and Postpartum Depression
Official title: Is Postpartum Anemia an Independent Risk Factor for Development of Postpartum Depression?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postpartum Depression
Keywords: postpartum anemia, postpartum depression
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
First posted: 2008-10-31
Enrollment: 103
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women after term elective cesarean section

Brief summary: Postpartum anemia (PPA) and Postpartum depression (PPD) are common afflictions affecting women after childbirth. Both disorders have a significant impact on women's health and functional status. Despite common symptoms and characteristics, a link between these entities has not been adequately studied. The objective of this study is to determine whether postpartum anemia is an independent risk factor for the development of postpartum depression. This prospective cohort study will include all women delivered by elective term cesarean delivery. Hemoglobin and iron levels will be measured, standardized questionnaires for assessment of PPD, functional status and lactation will be administered before discharge and at 3 \& 6 weeks post partum. Hemoglobin levels at each time point will be analyzed for correlation with depressive symptoms, functional status and lactation success.


Eligibility criteria: Inclusion Criteria:

* Women after term elective cesarean section

Exclusion Criteria:

* age \< 16 years, preterm (\< 37 weeks) delivery, multiple gestation, symptomatic anemia necessitating blood transfusion, significant fetal anomalies or infant not discharged with mother for other reason, preexisting severe chronic maternal illness, preexisting maternal depression and/or current use of antidepressants, other psychiatric illness (e.g. bipolar disease, schizophrenia) or preexisting hemoglobinopathy

Primary outcomes:
measure: Incidence of postpartum depression
timeFrame: 0-6 weeks postpartum
Secondary outcomes:
measure: Mean Edinburgh Postnatal Depression Scale results
timeFrame: 0-6 weeks postpartum
measure: Functional status
timeFrame: 0-6 weeks postpartum
measure: Lactation success
timeFrame: 0-6 weeks postpartum
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
Study officials:
affiliation: Unity Health Toronto
name: Howard Berger, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00941512: High Resolution Digital Imaging of the Uterine Cervix
Official title: Investigation to Correlate High Resolution Digital Images of the Uterine Cervix With Histopathology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colposcopy
Keywords: Colposcopy
Lead sponsor: STI-Medical Systems
Sponsor class: INDUSTRY
Collaborators: name: Instituto National de Edfermedades Neoplasicas
name: Eisenhower Army Medical Center
First posted: 2009-07-17
Enrollment: 112
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women identified with an abnormal Pap smear

Brief summary: This study was designed to gather digital pictures of the cervix and correlate it to its histopathology, and then use those relationships to teach a computer how to objectively find cervical dysplasia and cancer.


Eligibility criteria: Inclusion Criteria:

* Female
* Negative pregnancy test
* 18 years and older
* Presence of a cervix

Exclusion Criteria:

* Pregnant
* Absence of a cervix
* Less than 18 years old
* Male

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Augusta University
name: Daron G Ferris
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05888012: Balloon Catheter vs. Basket Catheter in Pancreatic Duct Stone Clearance
Official title: Efficacy and Safety Comparison of Balloon Catheter and Basket Catheter for Endoscopic Pancreatic Duct Stone Clearance
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Pancreatitis
Keywords: Pancreatic stone
Endoscopic retrograde cholangiopancreatography (ERCP)
Basket catheter
Balloon catheter
Stone clearance
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2023-06-05
Enrollment: 6493
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: CP patients with pancreatic duct stones who underwent ERCP between February 2012 and December 2021were identified. The diagnosis of CP was established based on computed tomography, magnetic resonance imaging or endoscopic ultrasound examinations.

Brief summary: The aim of the study is to compare the safety and efficacy of the basket catheter with that of the balloon catheter for endoscopic extraction of pancreatic stones.

Detailed description: This is a retrospective cohort study. Patients with chronic pancreatitis who underwent ERCP for pancreatic duct stone extraction using either a basket or a balloon catheter were enrolled in this study.

Eligibility criteria: Inclusion Criteria:

* CP patients with main pancreatic duct (MPD) stones who underwent ERCP

Exclusion Criteria:

* Patients had undergone pancreatic surgery or gastrectomy with Billroth II reconstruction prior to the ERCP procedure
* Patients were suspected of having a malignant tumor
* Patients combined with bile duct stones
* Patients had severe pancreatic duct structure
* Patients with insufficient clinical data
* Patients with previous ERCP treatment
* Patients had received both catheters

Primary outcomes:
measure: the rate of stone clearance in basket and balloon catheter groups
timeFrame: 1 year after ERCP
Secondary outcomes:
measure: the rates of ERCP peri-procedural outcomes and the rates of complications of ERCP in basket and balloon catheter groups
timeFrame: 1 year after ERCP
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changhai Hospital
state: Shanghai
Study officials:
affiliation: Changhai Hospital
name: Zhuan Liao
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04647812: Technology-assisted Rehabilitation After Acute Stroke
Official title: Technology-assisted Rehabilitation After Acute Stroke
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Lead sponsor: Vetrea Terveys Oy
Sponsor class: OTHER
Collaborators: name: Kuopio University Hospital
name: City of Kuopio
First posted: 2020-12-01
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Consecutive cohort study
Primary purpose: TREATMENT

Brief summary: The aim of the study is to evaluate the effects and costs of an intensified rehabilitation for stroke patients. Using novel technologies the patients will receive an augmented exercise therapy during the first weeks after stroke. The effects on restoration of functions as well as on the costs incurred from social and health care services will be assessed and compared to the conventional rehabilitation over 6 month follow-up.

Detailed description: The intervention consists of technology-assisted multidisciplinary rehabilitation for 3 weeks followed by an 8-week period of supervised home-based telerehabilitation and a weekly group exercise in an outpatient clinic. The effects on mobility, upper extremity motor functions and activities of daily living will be assessed using FAC, hand grip force, shoulder elevation test, WHODAS 2.0 and PROMIS scales. The costs incurred from social and health care services over 6 months will be compared to the control group receiving conventional rehabilitation. Patients aged 18 or more with their first stroke and stable cardiopulmonary condition will be consecutively recruited first into the control group (n=20) and thereafter into the experimental group (n=20). Patients with a severe cognitive deficit or aphasia will be excluded.

Eligibility criteria: Inclusion Criteria:

* age 18 or more
* first stroke

Exclusion Criteria:

* unstable cardiopulmonary condition
* severe cognitive disorder
* aphasia

Primary outcomes:
measure: WHODAS 2.0
timeFrame: 6 months
measure: service use and costs
timeFrame: 6 months
Secondary outcomes:
measure: PROMIS Global 10
timeFrame: 6 months
measure: FAC
timeFrame: 6 months
measure: Hand grip force
timeFrame: 6 months
measure: Shoulder elevation test
timeFrame: 6 months
Other outcomes:
Locations:
city: Kuopio
country: Finland
facility: Vetrea
state: North Savo
Study officials:
affiliation: Vetrea Terveys Oy
name: Kauko Pitkänen, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01834612: Evaluation of the Zynex Blood Volume Monitor in Healthy Adult Volunteers During a Blood Draw
Official title: Clinical Evaluation of the Zynex Blood Volume Monitor (CM1500) in Healthy Adult Volunteers During a Blood Draw
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Blood Loss
Keywords: blood loss, hemorrhage, hemorrhagic shcok
Lead sponsor: Zynex Monitoring Solutions
Sponsor class: INDUSTRY
First posted: 2013-04-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: To determine if a manual blood loss can be detected using the non-invasive blood monitor.


Eligibility criteria: Inclusion Criteria:

* healthy volunteer
* between 18 to 50 years of age
* weight between 157 to 220 lbs

Exclusion Criteria:

* unstable or untreated cardia disease
* alcohol consumption in 24 hours prior to screening
* tobacco use in 4 hours prior to screening
* pregnancy
* infection
* Hemoglobin \< 12.5 g/dL at time of procedure

Primary outcomes:
measure: Detect change in blood volume by non-invasive monitoring during whole blood draw
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lakewood
country: United States
facility: DaVita Clinical Research
state: Colorado
Study officials:
affiliation: Davita Clinical Research
name: Chris Galloway, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03749512: NLCR in Prediction of the Grade of Lung Tumor.
Official title: Preoperative Neutrophil-lymphocyte Count Ratio in Prediction of the Grade of Lung Tumor.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Neoplasm
Keywords: NLCR, The neutrophil-lymphocyte count ratio, Lung Neoplasm
Lead sponsor: Medical University of Silesia
Sponsor class: OTHER
First posted: 2018-11-21
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive thoracic surgery patients admitted to SPSK nr 1 in Zabrze between October 2014 and October 2018 with lung tumor qualified for thoracic surgery intervention

Brief summary: The aim of the study is to assess whether the value of neutrophil-lymphocyte count ratio from the routine preoperative blood test may predict lung tumors' grading.

Detailed description: Lung cancer remains as one of the leading causes of death among oncology patients. Close connection between inflammation and pathogenesis of some neoplasms was determined in a number of studies. Some studies show promise that ratio of neutrophil to lymphocyte count (NLCR) may be recognized as a prognostic marker for several carcinomas: renal, lung and colorectal. The aim of the study is to assess whether the value of neutrophil-lymphocyte count ratio from the routine preoperative blood test may predict lung tumors' grading. During routine preoperative blood tests complete blood count is done and NLCR, WBC, neutrophil and lymphocyte count is noted. After the thoracic surgery intervention and histopathological examination grading of lung tumor is noted.

Eligibility criteria: Inclusion Criteria:

* consecutive thoracic surgery patients with lung cancer grading confirmed by histopathology postoperatively
* preoperative routine complete blood count analysis

Exclusion Criteria:

* infectious disease
* pregnancy
* autoimmunologic disease
* other known conditions or treatments that may influence the blood count (seropositivity for HIV, chemotherapy, and corticotherapy)

Primary outcomes:
measure: Neutrophil-lymphocyte count ratio
timeFrame: From October 1, 2014 to October 15, 2018
Secondary outcomes:
measure: Neutrophil count
timeFrame: From October 1, 2014 to October 15, 2018
measure: Lymphocyte count
timeFrame: From October 1, 2014 to October 15, 2018
measure: Leucocyte count
timeFrame: From October 1, 2014 to October 15, 2018
Other outcomes:
Locations:
city: Zabrze
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny nr 1
state: Silesia
Study officials:
affiliation: Medical University of Silesia
name: Hanna Misiołek, MD PhD
role: STUDY_CHAIR
References:
Clinical trial NCT03189212: Feasibility Study of Telemedicine for Dialysis Patients Awaiting Transplantation
Official title: Feasibility Study of Telemedicine for Dialysis Patients Awaiting Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End Stage Renal Disease
Kidney Disease, Chronic
Keywords: Telemedicine
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2017-06-16
Enrollment: 15
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to determine whether a telemedicine follow-up visit at the NYU Langone Transplant Institute is a feasible and acceptable alternative to a traditional in-center follow-up visit.

Detailed description: A six-month prospective randomized-controlled clinical pilot study to evaluate a new intervention for the transplant program: telemedicine (TM) visits. Researchers will target patients on the transplant waiting list who are currently undergoing dialysis. Currently, there are 234 patients on the transplant waiting list who receiving care at dialysis centers in the New York City area. Researchers will select the 10 dialysis centers having the highest number of patients on the transplant list in order to yield a target sample of 45.

Eligible participants will be randomized to 1 of 2 groups: (1) usual care (UC) which is the routine 6-month follow up appointment at the NYULMC transplant center or (2) TM visit conducted at the patient's dialysis unit as a replacement to usual 6 month routine f/u visit. Patients will be followed for 4 months post randomization to determine the number of days that elapse between randomization and routine transplant evaluation. As new clinic appointments are currently experiencing 80-day wait, a 4-month follow-up should be more than adequate to evaluate this primary outcome.

The intervention will be evaluated primarily in terms of efficiency, and secondarily in terms of patient/physician experiences, changes in waiting list status, and referral for living donation.

Eligibility criteria: Inclusion Criteria:

* Receiving thrice-weekly hemodialysis treatment for 6 months
* On NYULMC kidney transplant wait list

Exclusion Criteria:

* Unable or unwilling to provide informed consent
* Unable to read or otherwise use an iPad (e.g. blind)

Primary outcomes:
measure: Waiting time
timeFrame: 4 Months
measure: Missed visits
timeFrame: 4 Months
measure: Cost
timeFrame: 4 Months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: Nicole Ali, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03802812: Thin Bronchoscope and Virtual Bronchoscopic Navigation System for Tuberculosis
Official title: Thin Bronchoscope and Virtual Bronchoscopic Navigation System for Rapid Detection of Mycobacterium Tuberculosis and Resistant-conferring Mutations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tuberculosis
Lead sponsor: Pusan National University Hospital
Sponsor class: OTHER
First posted: 2019-01-14
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study investigates the utility of thin bronchoscope and virtual bronchoscopic navigation system (targeted bronchial washing) for detection of M. tuberculosis and resistant-conferring mutations in patients with pulmonary tuberculosis. Time to appropriate treatment and stain/culture conversion are also evaluated.

Detailed description: Comparisons of detection rate of M. tuberculosis and resistant-conferring mutations between patients who perform CT-guided conventional bronchoscope and patients who perform VBN-guided thin bronchoscope.

Eligibility criteria: Inclusion Criteria:

* age of 18 or more
* persons who are suspected with pulmonary tuberculosis on radiologic examination
* persons who cannot spit sputum or persons with negative results on sputum AFB smear and TB-PCR or Xpert MTB/RIF assay

Exclusion Criteria:

* persons who do not agree with bronchoscopy (persons who want empirical treatment for TB)
* persons with contraindications for bronchoscopy

  * bleeding tendency
  * uncontrolled respiratory disease (hypoxemia)
  * uncontrolled cardiovascular disease

Primary outcomes:
measure: detection of M. tuberculosis and resistant-conferring mutations
timeFrame: 2months after procedure
Secondary outcomes:
measure: time to appropriate treatment and stain/culture conversion
timeFrame: 6months after procedure
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
Study officials:
affiliation: Pusan National University Hospital
name: Jeongha Mok, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02084212: Study of Retinal Sensitivity by Microperimetry During Epiretinal Membrane Surgery
Official title: Study of Retinal Sensitivity by Microperimetry During Epiretinal Membrane Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Epiretinal Membrane Surgery
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2014-03-11
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: The aim of this research is to assess current care by studying macular function using microperimetry and by then comparing visual acuity results with OCT (Optical Coherence Tomography) data.

The examinations performed are those usually done in the follow-up of epiretinal membrane surgery, apart from microperimetry which is an examination of the central visual field. Patients who undergo ERM surgery usually have a follow-up examination at 1 month, 3 months and 6 months after the surgery. The consultation includes an assessment of visual acuity, a fundus examination an SD-OCT of the retina. The present protocol will require no additional visits. The microperimetry will be done in addition to the usual follow-up examinations after ERM surgery.


Eligibility criteria: Inclusion Criteria:

* Persons who have provided consent,
* Patients about to undergo idiopathic epiretinal membrane surgery,
* Patients undergoing first-line macular surgery

Exclusion Criteria:

* Persons not covered by national health insurance
* Preexisting disease of macula/epiretinal membrane (ARMD, chorioretinal scarring)
* Preoperative amblyopic eye
* Insufficiently transparent media making it impossible to do the examinations

Primary outcomes:
measure: Change of visual acuity in ETDRS (Early Treatment Diabetic Retinopathy Study) scale
timeFrame: Up to 6 months after the operation.
measure: Anomalies observed in the outer layers of retina
timeFrame: Up to 6 months after the operation
measure: Evaluation of retinal sensitivity by microperimetry
timeFrame: Up to 6 months after the operation
Secondary outcomes:
measure: Abnormal surface autofluorescence
timeFrame: Up to 6 months after the operation
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU de DIJON
Study officials:
References: