louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00362661: Low-dose Cortisol in Chronic Posttraumatic Stress Disorder
Official title: Low-dose Cortisol in Chronic Posttraumatic Stress Disorder
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Posttraumatic Stress Disorder
Keywords: PTSD
cortisol
memory
treatment
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2006-08-10
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of this prospective, double-blind, placebo-controlled, cross-over study is to determine the therapeutic efficacy of low-dose cortisol for symptoms of chronic posttraumatic stress disorder.


Eligibility criteria: Inclusion Criteria:

* Female and male patients with chronic PTSD due to adult trauma; PTSD is diagnosed according to the DSM-IV, as measured with the CAPS
* Age between 18 and 60

Exclusion Criteria:

* History of disease states representing contraindications to glucocorticoid therapy (tuberculosis, gastritis, gastric- and duodenal ulcers, Cushing's disease, osteoporosis, hypertension, pregnancy (to exclude with a pregnancy test) and lactation, glaucoma, diabetes mellitus, thrombophilia, acute or chronic infections, hyperthyroidism, cirrhosis)
* Severe or chronic somatic diseases
* Topic glucocorticoid therapy (for large skin parts)
* Inhaled glucocorticoids
* Current psychotic, bipolar, substance-related, or severe personality disorder
* Current severe depressive disorder
* Severe cognitive impairment or a history of organic mental disorder
* Evidence of PTSD or depression immediately prior to the index trauma
* Prominent current suicidal or homicidal ideation
* Asylum seeking status
* Body weight \>20% above or below normal range
* Changes in psychopharmacologic or psychotherapeutic management less than 8 weeks before start of the study

Primary outcomes:
measure: CAPS CGI
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Department of Psychiatry, University Hospital Zurich
Study officials:
affiliation: Division of Psychiatry Research, University of Zurich, Lenggstr. 31, 8032 Zurich, Switzerland
name: Dominique de Quervain, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Psychiatry, University Hospital Zurich, Culmannstrasse 8, 8091 Zürich, Switzerland
name: Ulrich Schnyder, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Aerni A, Traber R, Hock C, Roozendaal B, Schelling G, Papassotiropoulos A, Nitsch RM, Schnyder U, de Quervain DJ. Low-dose cortisol for symptoms of posttraumatic stress disorder. Am J Psychiatry. 2004 Aug;161(8):1488-90. doi: 10.1176/appi.ajp.161.8.1488.
Clinical trial NCT02844361: Comparison of ASCT and Conventional Chemotherapy in High Risk Waldenström Macroglobulinemia
Official title: Autologous Stem-cell Transplantation Versus Conventional Chemotherapy for High Risk Waldenström Macroglobulinemia - a Prospective Multicentre Phase Ⅳ Trial From China
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Waldenström Macroglobulinemia
Keywords: high-risk
ASCT
Lead sponsor: Institute of Hematology & Blood Diseases Hospital, China
Sponsor class: OTHER
First posted: 2016-07-26
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate whether autologous stem cell transplantation will improve the survival of patients with high-risk Waldenström macroglobulinemia, compared with conventional chemotherapy.

Detailed description: WM patients with partial response after introduction chemotherapy will be recommended to adopt autologous stem cell transplantation or receive conventional chemotherapy (dependent on patient's choices). After transplantation or conventional chemotherapy, maintenance therapy with rituximab or thalidomide plus prednisone will be given for less than two years.

Eligibility criteria: Inclusion Criteria:

1. 70 years\>=Aged \>=18 years
2. diagnosed with high-risk LPL/WM according to the ISSWM criteria
3. untreated or mild treated without standard regimens
4. suitable for ASCT
5. with life-expectancy more than 3 months.

Exclusion Criteria:

1. diagnosed with other malignancies outside B-NHL within one year(including active center neural system lymphoma)
2. transformed lymphoma
3. liver or renal function lesion unrelated to lymphoma
4. serious complications such as uncontrolled diabetes, gastric ulcer or other serious angiocardiopathy determined by the physician
5. HIV positive or active HBV infection or other uncontrolled systematic infection
6. clinical central nervous dysfunction
7. serious surgery within 30 days
8. pregnancy or baby nursing period or un-contracepted child-bearing period woman; 9. allergy to the trail drugs.

Primary outcomes:
measure: progress-free survival
timeFrame: up to 36 months
Secondary outcomes:
measure: complete remission rate
timeFrame: up to 12 months
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Shuhua Yi
Study officials:
affiliation: blood disease hospital, Chinese Academic Medical School
name: Shuhua Yi, Doc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00859261: Two Dimensional (2D) Silicon Transducer-Compression Plates for Breast Ultrasound
Official title: 2D Silicon Transducer-Compression Plates for Breast Ultrasound
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Tumor
Breast Cysts
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Cancer Institute (NCI)
First posted: 2009-03-11
Enrollment: 21
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The study purpose is to help in the developement of 3 dimensional breast ultrasound imaging.

Detailed description: To assist in the developement of 3 dimensional breast ultrasound imaging and when possible compare the ultrasound results with 3D mammography (digital tomosynthesis mammography)or clinical mammography and ultrasound. Hopefully that this new, 3D ultrasound imaging can provide important information not found on mammograms or routine breast ultrasound.

Eligibility criteria: Inclusion Criteria:

* Healthy women OR
* Women with suspected benign masses who may/or may not be going to biopsy
* Women with cysts where no biopsy is recommended

Exclusion Criteria:

* Women who are pregnant
* Women with breast implants
* Prisoners

Primary outcomes:
measure: To prove the significance/capability of 3D Ultrasound imaging in comparison to current mammographic imaging.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan Basic Science Division
name: Paul Carson, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03352661: Influence of an Endometrioma on Oocyte Quality
Official title: Influence of an Endometrioma on Oocyte Quality
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Endometriosis
Lead sponsor: IVI Vigo
Sponsor class: OTHER
First posted: 2017-11-24
Enrollment: 80
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients \<40 years, BMI \<30kg / m2,

Brief summary: The purpose of this study is to evaluate if there are differences in oocyte quality depending on whether these oocytes come from an ovary in contact with an endometrioma.

Detailed description: There is no consensus for whether an endometrioma influences oocyte quality, as well as the possible mechanisms that induce them.

In this study, the oocyte maturation will proof oocyte quality: This mean, the percentage of oocytes in metaphase II obtained after stimulation, as well as the rate of oocytes fertilized in direct contact with an endometrioma.

Eligibility criteria: Inclusion Criteria:

* Patients \<40 years, BMI \<30kg / m2,

Exclusion Criteria:

-

Primary outcomes:
measure: Percentage of mature oocytes
timeFrame: Up to 36 months
measure: Fertilization rate
timeFrame: Up to 36 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: IVI Vigo
name: Elkin Muñoz, Principal Investigator
role: PRINCIPAL_INVESTIGATOR
References:
citation: Garcia-Velasco JA, Mahutte NG, Corona J, Zuniga V, Giles J, Arici A, Pellicer A. Removal of endometriomas before in vitro fertilization does not improve fertility outcomes: a matched, case-control study. Fertil Steril. 2004 May;81(5):1194-7. doi: 10.1016/j.fertnstert.2003.04.006.
citation: Garrido N, Navarro J, Remohi J, Simon C, Pellicer A. Follicular hormonal environment and embryo quality in women with endometriosis. Hum Reprod Update. 2000 Jan-Feb;6(1):67-74. doi: 10.1093/humupd/6.1.67.
citation: Filippi F, Benaglia L, Paffoni A, Restelli L, Vercellini P, Somigliana E, Fedele L. Ovarian endometriomas and oocyte quality: insights from in vitro fertilization cycles. Fertil Steril. 2014 Apr;101(4):988-93.e1. doi: 10.1016/j.fertnstert.2014.01.008. Epub 2014 Mar 3.
Clinical trial NCT01649661: MRI Parenchymal Enhancement: A New Marker of Breast Cancer Risk
Official title: Epidemiology of MRI Parenchymal Enhancement: A New Marker of Breast Cancer Risk
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer Free Women
Keywords: MRI
12-125
premenopausal women
postmenopausal women
questionnaire
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: University of Southern California
name: University of Toronto
First posted: 2012-07-25
Enrollment: 437
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The proposed study will involve cancer-free women who are undergoing breast MRI screening at MSKCC.

Brief summary: The purpose of this study is to learn about how a woman's health history influences what a normal breast looks like on an MRI. The investigators also want to learn about how the amount of different natural hormones a woman has affects how the breast looks on an MRI. The investigator's hope is that this will help to find women at a high-risk of breast cancer.


Eligibility criteria: Inclusion Criteria:

* age 21 years or older
* be a cancer-free pre- or postmenopausal woman
* have no prior personal history of any cancer (including DCIS, excluding nonmelanoma skin-cancer)
* able to speak and read English because the questionnaire is only available in English
* able to provide informed consent

Exclusion Criteria:

* are pregnant at the time of MRI
* have a prior personal history of any cancer (including DCIS, excluding nonmelanoma skin cancer)

Primary outcomes:
measure: breast cancer risk factors and background parenchymal enhancement (BPE).
timeFrame: 1 year
Secondary outcomes:
measure: relationship between BPE and serum hormone levels at the time of MRI
timeFrame: 1 year
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Janice Sung, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00348361: Exploration Of Key Targets And Biomarkers Involved In An Allergic Response In Subjects With Allergic Rhinitis (Hay Fever)
Official title: A Study to Validate Key Therapeutic Targets and Biomarkers During Allergen Exposure in Subjects With Allergic Rhinitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Allergic Rhinitis
Keywords: Hay fever
biomarkers
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-07-04
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: This study is aimed at validating key therapeutic targets and biomarkers associated with allergic rhinitis. The therapeutic target expression will be investigated after a 7 day course of corticosteroid treatment followed by allergen challenge.


Eligibility criteria: Inclusion criteria:

* No signs or symptoms of rhinitis outside of the relevant airborne allergen season.

Exclusion criteria:

* History or current evidence of an upper or lower respiratory infection or symptoms (including common cold) within 2 weeks of baseline assessments.
* Symptoms of rhinitis at inclusion indicated by total VAS score of \>40 for the combined symptoms scores for blockage, rhinorrhoea, sneezing, itching) or a single symptom with a VAS score \>20.
* Subjects not showing a nasal response to allergen concentration =\< 10,000 BU/ml.
* Subjects with positive skin prick test for Dust House Mite.

Primary outcomes:
measure: Change in expression of key allergy targets in the nose following exposure to allergen. Assessment of protein expression measured by western blotting and immunohistochemistry in nasal biopsy tissue.
Secondary outcomes:
measure: Effect of corticosteroids treatment on the change in target expression following allergen challenge. Nasal lavage fluid and nasal secretions will be measured by ELISA and chemiluminescent assay.
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: GSK Investigational Site
city: London
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials, MD,MSc, FPPM
role: STUDY_DIRECTOR
References:
Clinical trial NCT02944461: Efficacy and Safety of Aczone 7.5% Gel in the Treatment of Truncal Acne Vulgaris
Official title: Efficacy and Safety of Aczone 7.5% Gel in the Treatment of Truncal Acne Vulgaris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acne
Lead sponsor: Derm Research, PLLC
Sponsor class: OTHER
First posted: 2016-10-25
Enrollment: 20
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To determine if Dapsone (Aczone) 7.5% gel is a safe and effective treatment for acne on the trunk

Detailed description: This is an open label pilot study to determine the safety and efficacy of Dapsone (Aczone) 7.5% gel applied daily to the trunk for acne. Subjects will apply Dapsone for 16 weeks.

Eligibility criteria: Inclusion Criteria:

* Male and female subjects of any race and at least 12 years of age.
* Female subjects of childbearing potential must have a negative urine pregnancy test at Baseline and practice a reliable method of contraception throughout the study.
* Truncal acne IGA score of 3.
* Able to understand the requirements of study and sign Informed Consent/HIPAA forms.

Exclusion Criteria:

* Female subjects who are pregnant , breast feeding or are of childbearing potential who are not willing to use a reliable method birth control.
* Subjects who have an allergy or sensitivity to any component of the test medication.
* Subjects who have not complied with the proper wash out periods for prohibited medications.
* Evidence of recent drug or alcohol abuse.
* Skin disease /disorder that might interfere with the diagnosis or evaluation of truncal acne.
* Exposure to an investigational drug within 30 days of the Baseline visit.
* Medical condition that contraindicates the subject's participation in the study.
* History of poor cooperation, non-compliance with medical treatment or unreliability.

Primary outcomes:
measure: Percent of Subjects Who Achieve at Least a Two Grade Improvement and a Rating of Clear or Almost Clear on the Investigator Global Assessment (IGA) Scale
timeFrame: 16 weeks
Secondary outcomes:
measure: The Percent Change in Inflammatory Lesion Count at Week 16 Compared to Baseline
timeFrame: 16 Weeks
measure: The Percent Change in Non-inflammatory Lesion Count at Week 16 Compared to Baseline
timeFrame: 16 Weeks
measure: The Percent Change in Total Lesion Count at Week 16 Compared to Baseline
timeFrame: 16 Weeks
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Dermatology and Laser Surgery
state: California
city: Louisville
country: United States
facility: DermResearch, PLLC
state: Kentucky
city: Las Vegas
country: United States
facility: James Q. DelRosso DO, LLC
state: Nevada
Study officials:
affiliation: DermResearch PLLC
name: Leon H. Kircik, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01887561: Dasatinib for Patients Achieving Complete Molecular Response for Cure D-NewS Trial
Official title: PhaseⅡClinical Trial of Dasatinib for Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase and Stop Therapy After Achieving Complete Molecular Response for Cure D-NewS
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Myelogenous Leukemia, Chronic, Chronic Phase
Lead sponsor: Kanto CML Study Group
Sponsor class: OTHER
First posted: 2013-06-27
Enrollment: 100
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess whether dasatinib can be discontinued without occurrence of molecular relapse in patients with chronic myeloid leukemia in chronic phase in complete molecular remission(CMR) while on dasatinib.


Eligibility criteria: Inclusion Criteria:

* Newly diagnosed Chronic Myeloid Leukemia in the Chronic Phase
* 15 years old over.
* ECOG performance status (PS) score 0-2.
* Adequate organ function (hepatic, renal and lung).
* Signed written informed consent.

Exclusion Criteria:

* A case with the double cancer of the activity.
* Women who are pregnant or breastfeeding.
* female patient who there is not intention with an appropriate sterilization, or cannot use it during a study entry period
* Patients with complications or a history of severe or uncontrolled cardiovascular failure following have a Myocardial infarction within 6 months have an Angina within 3 months have a Congestive heart failure within 3 months have a QTc interval of more than 450msec at baseline
* A serious uncontrolled medical disorder that would impair the ability of the subjects to receive protocol therapy

Primary outcomes:
measure: The overall probability of maintenance of complete molecular remission after stopping dasatinib as measured by RQ-PCR
timeFrame: by 12 months
Secondary outcomes:
measure: 'Dasatinib affects immunological responses, as measured by flow cytometry
timeFrame: at 3,6,12,24 months
measure: Major Molecular Response(MMR) rate measured by RQ-PCR
timeFrame: by 1 months, then every 6 months for 2 years
measure: Complete Cytogenetic Response (CCyR) rate
timeFrame: by 6,12 months
measure: Progression free survival (PFS)
timeFrame: Participants were followed for at least 2 years
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: Participants were followed for at least 2 years
measure: The overall probability of maintenance of complete molecular remission after stopping dasatinib as measured by RQ-PCR
timeFrame: by 3,6 months
measure: Molecular remission rate measured by PQ-PCR after dasatinib re-challenge in cases of molecular relapse
timeFrame: by 12 months after molecular relapse
measure: Complete Molecular Response(CMR) rate measured by RQ-PCR
timeFrame: by 1 months, then every 6 months for 2 years
Other outcomes:
Locations:
city: Tachikawa city
country: Japan
facility: National Disaster Medical Center
state: Tokyo
Study officials:
References:
Clinical trial NCT06168461: Daily Aspirin Treatment After Preeclampsia
Official title: Aspirin for the Treatment of Vascular Dysfunction After Preeclampsia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Preeclampsia
Keywords: preeclampsia
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2023-12-13
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Women who develop preeclampsia during pregnancy are four times more likely to develop cardiovascular disease later in life, even if they are otherwise healthy. The reason why this occurs may be related to lasting blood vessel damage after the pregnancy but there are currently no specific treatment strategies to prevent this disease progression. This study addresses this public health issue by examining whether starting low dose aspirin therapy after pregnancy is an effective treatment for lasting blood vessel damage in order to inform better clinical management of cardiovascular disease risk in women who have had preeclampsia.


Eligibility criteria: Inclusion Criteria:

* had preeclampsia in the past 5 years,
* 18 years or older

Exclusion criteria:

* current daily aspirin use,
* skin diseases,
* current tobacco or nicotine use (including vaping),
* diagnosed or suspected hepatic or metabolic disease including chronic kidney disease (CKD) defined as reduced eGFR \< 60 mL/min/1.73m2,
* statin or other cholesterol-lowering medication,
* current antihypertensive medication,
* history of hypertension prior to pregnancy,
* history of gestational diabetes,
* currently pregnancy,
* body mass index \<18.5 kg/m2,
* allergy to materials used during the experiment.(e.g. latex),
* known allergies to study drugs,
* bleeding disorders, peptic ulcer disease, gastritis, GI bleeding and gastroesophageal reflux disease (GERD).

Primary outcomes:
measure: magnitude of microvascular endothelial function
timeFrame: baseline, 12 weeks
measure: magnitude of brachial artery endothelial function
timeFrame: baseline, 12 weeks
measure: magnitude of microvascular endothelin-1 mediated constriction
timeFrame: baseline, 12 weeks
Secondary outcomes:
measure: magnitude of microvascular nitric oxide-dependent dilation
timeFrame: baseline, 12 weeks
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
Study officials:
References: