louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01823172: Second Echelon Node Study With Methylene Blue
Official title: Feasibility of Lymphatic Mapping of Second Echelon Lymph Nodes With Methylene Blue
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Melanoma
Keywords: breast cancer
melanoma
sentinel lymph node biopsy
lymphadenectomy
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2013-04-04
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The investigators plan to study the ability to identify the lymph nodes beyond the sentinel lymph node that may harbor cancer using methylene blue dye.

Detailed description: After lymphatic mapping of the SLN with Tc-99 sulfur colloid only, the second-echelon lymphatic mapping was then performed with methylene blue dye by injecting the SLN with 0.05-0.10 cc non dilute methylene blue and tracing via the efferent lymphatic channel to the second echelon lymph node (Figure 1). For our initial patients a 27 gauge needle and 3cc syringe was utilized but this was modified over the study to a 30 gauge needle and 1cc syringe. The blue efferent lymphatic was traced with minimal spreading of the surrounding tissue to visualize its drainage into the next lymph node(s). A second echelon lymph node was considered any blue lymph node or any lymph node with blue dye leading directly into it. The number of second echelon lymph nodes was recorded. The second-echelon lymph node(s) was not removed.

Eligibility criteria: Inclusion Criteria:

* Histologically confirmed primary cutaneous melanoma located on the extremity or trunk
* Patients with clinically stage I-II melanoma
* Histologically confirmed invasive ductal or lobular carcinoma
* Patient undergoing surgical treatment of breast primary and sentinel lymph node biopsy- clinically node negative

Exclusion Criteria:

* Melanoma located on the head or neck, uveal or mucosal
* Previous surgery or radiation in or near the sentinel lymph node biopsy nodal basin
* Preoperative biopsy proven regional lymph node involvement
* Failure of lymphatic mapping with radioactive colloid
* Women who are pregnant or nursing
* Prior ipsilateral axillary surgery or radiation
* Inflammatory breast cancer
* No lymph node identified in the ipsilateral breast during pathologic review of the mastectomy specimen
* Stage IV breast cancer

Primary outcomes:
measure: The number of subjects in whom a secondary echelon lymph node is identified
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: James Jakub, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02898272: SCCOR Minorities Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease, Chronic Obstructive
Emphysema
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2016-09-13
Enrollment: 40
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: - African American male and female subjects participating in COPDGene study

Brief summary: The SCCOR Minorities study will recruit minority participants from the COPDGene cohort, in whom the University of Pittsburgh has already obtained baseline and five year data, in order to enhance bone mineral density and vascular function data collection from minority smokers. Dual X-ray absorptiometry (DXA) scans will be obtained to measure bone mineral density. Non-invasive vascular studies will be performed to measure endothelial function. Questionnaires regarding symptoms and activity levels will be administered and a blood sample will be obtained in participants in which blood samples are not already available from the COPDGene study visits.


Eligibility criteria: Inclusion Criteria:

* African American male and female subjects participating in COPDGene study

Exclusion Criteria:

* caucasians
* pregnant women

Primary outcomes:
measure: Dual Xray Absorptiometry measurement of lumbar spine and hip bone mineral density.
timeFrame: As this is a cross-sectional collection of data, the outcome will be measured once at the first and only study visit.
Secondary outcomes:
measure: Measurement of carotid artery intimal thickness with ultrasound
timeFrame: As this is a cross-sectional collection of data, the outcome will be measured once at the first and only study visit.
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01274572: Blood for Immune Response to Provenge® in HRPC
Official title: Blood Samples to Evaluate Immune Response to Provenge® (Sipuleucel-T) inHormone Refractory Metastatic Prostate Cancer Patients
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Prostate Cancer
Lead sponsor: Mary Crowley Medical Research Center
Sponsor class: OTHER
First posted: 2011-01-11
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects that will be included in this study will be receiving Provenge as standard of care treatment for their prostate cancer and will be willing to consent to the additional blood draws.

Brief summary: This study is being conducted to assess and monitor immune response in patients with minimally symptomatic or asymptomatic hormone refractory prostate cancer who will be receiving Provenge® (Sipuleucel-T) therapy as part of their standard of care treatment regimen.

Detailed description: This study is being conducted to assess and monitor immune response in patients with minimally symptomatic or asymptomatic hormone refractory prostate cancer who will be receiving Provenge® (Sipuleucel-T) therapy as part of their standard of care treatment regimen. The trial only involves the collection of additional blood samples for the purposes of monitoring immune response. These samples will be taken at 7 time points before, during and after patients receive Provenge® (Sipuleucel-T). There will be no other study-specific procedures performed (other than the blood draws) nor any use of investigational agents in this study.

Eligibility criteria: Inclusion Criteria:

Patients who plan to receive standard of care Provenge® (Sipuleucel-T) at their primary physican's office.

Exclusion Criteria:

None

Primary outcomes:
measure: Immune Response
timeFrame: Additional Blood Sample
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Mary Crowley Cancer Research Centers
name: John Nemunaitis, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02209168: Differences in Ovarian Reserve Markers and Vitamin D Between Infertile Indian, Arabian and Caucasian Population
Official title: Differences in Ovarian Reserve Markers, Vitamin D Serum Levels and Reproductive Outcomes Between Infertile Indian, Arabian and Caucasian Population
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Female Infertility Due to Diminished Ovarian Reserve
Vitamin D Deficiency
Hormone Deficiency
Follicular Cyst of Ovary
Keywords: AMH, ACF, VIT D, Ethnicity
Lead sponsor: IVI Madrid
Sponsor class: OTHER
First posted: 2014-08-05
Enrollment: 0
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 43
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: WOMEN BETWEEN 21-43 YEARS FIRST OR SECOND IN VITRO FERTILIZATION TREATMENT DUE TO TUBAL, MASCULINE OR PREVIOUS INTRAUTERINE INSEMINATION FAIL TREATMENT

Brief summary: The aim of this study is to confirm the difference in ovarian reserve markers and serum vitamine D levels between infertile indian, arabian and caucasian population.

Detailed description: 200 caucasian, indian, and arab patients

Eligibility criteria: Inclusion Criteria:

WOMEN BETWEEN 21-43 YEARS FIRST OR SECOND IN VITRO FERILIZATION TREATMENT DUE TO TUBAL, MASCULINE OR PREVIOUS INTRAUTERINE INSEMINATION FAIL TREATMENT

Exclusion Criteria:

POLYCYSTIC PATIENTS ENDOMETRIOSIS GRADE III OR IV INFLAMMATORY PELVIC DISEASE

Primary outcomes:
measure: Ovarian reserve markers: antimullerian hormone, FSH, antral follicle count
timeFrame: beginning of the treatment cycle
Secondary outcomes:
measure: Serum vitamin D levels
timeFrame: Beginning of their treatment cycle
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: IVI Madrid
Study officials:
affiliation: IVI Madrid
name: CARLOS IGLESIAS, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00885768: Prevalence of Renal Artery Stenosis in Patients Referred for Cardiac Catheterization
Official title: Prevalence of Renal Artery Stenosis in Patients Refered for Cardiac Catheterization to Heart Center Hospital in July-September 2008
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Artery Stenosis
Keywords: RAS(renal Artery Stenosis)
Atherosclerosis
angiography
Lead sponsor: Imam Khomeini Hospital
Sponsor class: OTHER
Collaborators: name: Tehran Heart Center
First posted: 2009-04-22
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients reffered to the Tehran Heart center for coronary angiography

Brief summary: All patients referred for coronary angiography will simultaneously be evaluated for renal artery stenosis and then stenosis more than 50% will be analyzed according to clinical conditions, risk factors and lab data.

Detailed description: Renal Artery Stenosis (RAS) is a common finding in patients with generalized atherosclerosis. It is the cause of 15-20% of end stage renal disease in elderly patients. The prevalence of asymptomatic RAS in general population is unknown but it estimated to be 18% in 7th decade and more than 50% in the 8th. It is critical to find and manage the RAS before it's symptoms appear. The Gold standard for diagnosis of atherosclerotic arterial stenosis is angiography. In this study we will evaluate the prevalence, severity, location and related factors to renal artery stenosis in patients whom referred for coronary angiography in period of July-September in one of the most referral heart center in Iran, "The Tehran heart center" which is doing more than 50 coronary angiography daily.

Eligibility criteria: Inclusion Criteria:

* age more than 18 years

Exclusion Criteria:

* contraindication to contrast use
* not signing consent

Primary outcomes:
measure: Prevalence of Renal Artery Stenosis (RAS)
timeFrame: 2 months
measure: The Number of Patients With Renal Artery Stenosis
timeFrame: 3months
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Tehran Heart Center
Study officials:
References:
Clinical trial NCT03935568: A Single and Multiple Ascending Dose Study to Evaluate the Safety and Pharmacokinetics of PU-AD in Healthy Subjects
Official title: A Single and Multiple Ascending Dose Study to Evaluate the Safety and Pharmacokinetics of PU-AD in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Alzheimer's Disease
Keywords: PU-AD
Lead sponsor: Samus Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2019-05-02
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a first in human Phase 1 study in two parts with healthy volunteers receiving a single dose of PU AD in three small cohorts and a multiple ascending dose in two small cohorts.

Detailed description: This is a Phase 1, double-blind trial in two parts. A single ascending dose study in approximately 3 cohorts receiving a single oral dose of PU-AD or placebo and a multiple ascending dose study in 2 cohorts. Each subject in all cohorts will be administered an oral solution of PU AD or placebo under fasting conditions. Each cohort will contain subjects randomized to active treatment or placebo, evaluating safety and tolerance.

Eligibility criteria: Inclusion Criteria:

1. Male or female (Women of non-child bearing potential)
2. 18 to 60 years of age for part one, \>/= 60 years of age for part two

Exclusion Criteria:

1. Women of child bearing potential or Female with positive pregnancy test or who is lactating.
2. History or presence of conditions, which in the judgment of the PI, are known to interfere with the absorption distribution, metabolism, or excretion of drugs.
3. History or presence of conditions that may place the subject at increased risk as determined by the PI.
4. Has taken other investigational drugs or participated in any clinical study within 30 days.
5. Any other condition or prior therapy that, in the PI's opinion, would make the subject unsuitable for the study, or unable or unwilling to comply with the study procedures

Primary outcomes:
measure: To evaluate the safety and tolerability of single and multiple doses of PU-AD in healthy subjects
timeFrame: Day 1 to Day 3
measure: To evaluate the safety and tolerability of single and multiple doses of PU-AD in healthy subjects
timeFrame: Day 1 to Day 3
measure: To evaluate the safety and tolerability of single and multiple doses of PU-AD in healthy subjects
timeFrame: Day 1 to Day 3
Secondary outcomes:
measure: To determine the pharmacokinetics (PK) PU-AD in healthy subjects
timeFrame: Day 1 to Day 3
measure: To determine the pharmacokinetics (PK) PU-AD in healthy subjects
timeFrame: Day 1 to Day 3
measure: To determine the pharmacokinetics (PK) PU-AD in healthy subjects
timeFrame: Day 1 to Day 3
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: ICON Early Phase Services
state: Texas
Study officials:
affiliation: Samus Therapeutics
name: Michael H Silverman, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT03061968: Study of Applying Acupressure in Low-birth Weight Premature
Official title: Study of Appling Acupressure in Low-birth Weight Premature
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Premature
Keywords: acupressure
very-low- birth-weight premature
body weight
behavioral state
developmental status
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
Collaborators: name: China Medical University Hospital
First posted: 2017-02-23
Enrollment: 60
Sex: ALL
Maximum age (years): 37
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to investigate the effects of acupressure application in very low birth weight premature.

Detailed description: A quasi-experimental study is designed. Sixty premature babies will be recruited by purposed sampling, according to the criteria of very low birth weight (\<1500gm) from a sick baby room in a medical center. The control group only receive routine care in sick baby room unite. The babies in experimental group will be observed for one day, and then intervene the simplified acupressure three times a day for 15 days, and continuously recoding the observation and records until discharge. The intervention includes acupressure for 15 minutes each at 10Am, 1Pm and 4Pm.

Eligibility criteria: Inclusion Criteria:

* according to the criteria of very low birth weight (\<1500gm) from a sick baby room in a medical center.

Exclusion Criteria:

* Exclusion criteria of very low birth weight (\>1500gm) from a sick baby room in a medical center.

Primary outcomes:
measure: Body Weight
timeFrame: 15 days.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01897168: Bone Mineral Content in Healthy Children
Official title: Bone Mineral Content in Healthy Children
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Healthy
Lead sponsor: Arkansas Children's Hospital Research Institute
Sponsor class: OTHER
First posted: 2013-07-11
Enrollment: 150
Sex: ALL
Minimum age (years): 5
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy children

Brief summary: The primary purpose of this study is to determine the effects of early diet on bone health.


Eligibility criteria: Inclusion Criteria:

* Current or past participation in the Beginnings study (IRB#07180)
* Age 5-7 years

Exclusion Criteria:

* Growth or bone disorders
* Non-removal metal on participant
* Any other conditions that may affect the outcome of interest as determined by the PI.

Primary outcomes:
measure: Bone health assessed by pQCT and DXA
timeFrame: 5-7 years
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Children's Nutrition Center
state: Arkansas
Study officials:
affiliation: Arkansas Children's Nutrition Center
name: Jin-Ran Chen, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05555368: Turkish Validity and Reliability of the Recovery Scale QoR-15
Official title: Turkish Validity and Reliability of the Recovery Scale QoR-15
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Behavior
Lead sponsor: Ondokuz Mayıs University
Sponsor class: OTHER
Collaborators: name: Samsun Education and Research Hospital
First posted: 2022-09-26
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: It is adapted and encouraged to a point to improve their quality of intervention for the purpose of the research.

Detailed description: This research was conducted as a methodological and descriptive study to evaluate the psychometric properties of the "Quality of Recovery Score" in patients who had surgery. The study was carried out with the participation of 150 patients over the age of 18 who were operated under general anesthesia in Samsun Training and Research Hospital between 8.11.2021 and 3.01.2022.

Eligibility criteria: Inclusion Criteria:

* over 18 years
* operated under general anesthesia

Exclusion Criteria:

* non-operative under general anesthesia
* under 18 years old

Primary outcomes:
measure: The Turkish validity of the QoR-15 version of the Quality of Healing Scale
timeFrame: 6 mounth
Secondary outcomes:
Other outcomes:
Locations:
city: Samsun
country: Turkey
facility: Ümmühan Kılıç
Study officials:
References:
Clinical trial NCT04663568: Levonorgestrel-releasing Intrauterine System and Tubal Ligation
Official title: Levonorgestrel-releasing Intrauterine System: A Emerging Tool for Conservative Treatment of Pain and Bleeding After Tubal Ligation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Tubal Ligation
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-12-11
Enrollment: 2
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Today tubal sterilization is a simple, safe, and cost-effective method of achieving long-term contraception. Sterilization is an ideal method of permanent contraception in developing countries where access to health care providers is limited. The percentage of women who use sterilization as a method of contraception rises from about 5% between 20 and 24 years of age to almost 50% for those between 40 and 44 years of age. The most widely touted and most significant health benefit of tubal sterilization appears to be a reduced risk of ovarian cancer.

Post-tubal ligation syndrome includes pain during intercourse, aching lower back, premenstrual tension syndrome, uterine hemorrhage, and absence of menstruation. The syndrome is caused by blood circulation problems in and around the Fallopian tubes and ovaries, pressure on nerves, and intrapelvic adhesion. Since the symptoms of this syndrome are mild, simple symptomatic treatment is sufficient in most cases. In some cases, however, hysterectomy may be necessary.


Eligibility criteria: Inclusion Criteria:

* Women aged from 30-40 year
* Woman subjected to tubal ligation
* Women 12 month postpartum
* Non lactating women
* Nomedical disorders

Exclusion Criteria:

* contraindication for Levonorgestrel-releasing Intrauterine System
* Women with any uterine or ovarian pathology
* women refuse to participate

Primary outcomes:
measure: The level of pain from before to 6 months after levonorgestrel-releasing intrauterine system insertion
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Women Health Hospital - Assiut university
Study officials:
References:
Clinical trial NCT01180868: The Biodistribution of 1-L-(2 Deoxy-2,- 18 Fluoroarabinofuranosyl) Cytosine ([18F]L-FAC) in Healthy Subjects and Patients With Cancer, Autoimmune and Inflammatory Diseases
Official title: The Biodistribution of 1-L-(2 Deoxy-2,- 18 Fluoroarabinofuranosyl) Cytosine ([18F]L-FAC) in Healthy Subjects and Patients With Cancer, Autoimmune and Inflammatory Diseases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Autoimmune Diseases
Cancer
Keywords: imaging probe
cancer
inflammatory tissue
inflammatory diseases
Lead sponsor: Jonsson Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2010-08-12
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with cancer, patients with autoimmune dosorders, and healthy subjects.

Brief summary: The purpose of this study is to determine the biodistribution of a new agent 1-L-(2 deoxy-2,-18fluoroarabinofuranosyl) cytosine non-invasively in healthy humans and to evaluate whether it can be used to image cancer, autoimmune disease, and inflammation


Eligibility criteria: Inclusion Criteria:

* greater than 18 years of age
* women of childbearing potential will undergo a pregnancy test free of charge
* patients with hematological malignancies, solid tumors or autoimmune disorders

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Christiaan Schiepers, M.D. Ph.D
role: PRINCIPAL_INVESTIGATOR
References: