louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04639505: Predictive Value of New AMH Test Method for Ovarian Response
Official title: Predictive Value of New AMH Test Method for Ovarian Response in Patients With IVF/ICSI
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility
AMH
Lead sponsor: Reproductive & Genetic Hospital of CITIC-Xiangya
Sponsor class: OTHER
First posted: 2020-11-20
Enrollment: 454
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: infertility females

Brief summary: In China, the incidence of infertility is about 15%, and patients need to use assisted reproductive technology (ART) to obtain pregnancy. It is particularly important to accurately predict the patient's ovarian response before initiating controlled ovulation hyperstimulation (COH). At present, the commonly used AMH detection method is enzyme-linked immunoassay (ELISA), and it has obtained the normal reference range for ovarian response. In recent years, with the development of detection technology, chemiluminescence immunoassay（CLIA） detection reagents have been successively used for the detection of AMH. However, there are few studies on the comparison of these two detection methods. The predictive value of the new method on ovarian response was lack. Therefore, by comparing the two methods of ELISA and CLIA detection of AMH levels in this study, the predictive value of poor ovarian response (the number of retrieved oocyte ≤ 3) and high response (the number of retrieved oocyte ≥ 15) in IVF/ICSI stimulation cycle was analyzed. In order to provide more reference basis for individualized COH, the AMH cutoff value of low and high ovarian response by the new method predicts was analyzed. At the same time, the prediction value of the two methods is compared to determine whether the new CLIA is suitable for clinical application.


Eligibility criteria: Inclusion Criteria:

* The first IVF/ICSI COH cycle;
* the causes of infertility :fallopian tube factors and/or male factors;

Exclusion Criteria:

* Endometriosis;
* PCOS;
* Adenomyosis;
* PGT cycle because of the female chromosome abnormality or genetic abnormality;
* FET cycle;
* Malignant tumor patient.

Primary outcomes:
measure: the AMH（CLIA） cutoff value of low and high ovarian response
timeFrame: the day of oocytes retrieved，about three months after AMH test
Secondary outcomes:
measure: Number of oocytes retrieved
timeFrame: 34-36 hours after hCG trigger，about three months after AMH test
measure: the serum AMH level
timeFrame: any day of the menstrual cycle, about three months after study starting
Other outcomes:
Locations:
city: Changsha
country: China
facility: Reproductive & Genetic Hospital of CITIC-XIANGYA
state: Hunan
Study officials:
affiliation: Reproductive & Genetic Hospital of CITIC-Xiangya
name: Fei Gong, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05769205: MRI in Ovarian Tumors
Official title: Role of Multi Paramertic MRI and MRI Perfusion in Indetermint Ovarian Lesions by Using ORADS MRI
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Ovarian Neoplasms
Lead sponsor: Assiut University
Sponsor class: OTHER
Collaborators: name: principle investigator
First posted: 2023-03-15
Enrollment: 25
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: females with ovarian masses
Primary purpose: DIAGNOSTIC

Brief summary: Role of multi paramrtric MRI and MRI perfusion in indetermint ovarian lesions by using ORADS MRI

Detailed description: Aim of study the purpose of this study is to investigate the capabilities of multi parametric MRI including DCE perfusion and DWI to discriminate between benign and malignant ovarian masses .

Eligibility criteria: Inclusion Criteria: females with ovarian masses

-

Exclusion Criteria:

* females with known benign ovarian masses

Primary outcomes:
measure: MRI in ovarian tumors
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Patel RK, Garg A, Dixit R, Gandhi G, Khurana N. The role of "penumbra sign" and diffusion-weighted imaging in adnexal masses: do they provide a clue in differentiating tubo-ovarian abscess from ovarian malignancy? Pol J Radiol. 2021 Dec 15;86:e661-e671. doi: 10.5114/pjr.2021.111986. eCollection 2021.
Clinical trial NCT01143805: A Study To Estimate The Amount Of CP-690,550 (Study Drug) That Is Absorbed Into The Blood Of Healthy Subjects Following Oral Administration Of CP-690,550 In Tablet Form
Official title: A Phase 1, Open Label, Single Dose, Randomized, Cross Over Study To Estimate The Absolute Oral Bioavailability Of CP-690,550 In Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Absolute Bioavailability
Rheumatoid Arthritis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-06-14
Enrollment: 12
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: In this study, a 10 mg dose of CP-690,550 will be given to study subjects on two separate occasions by two different routes of administration: One time by mouth in tablet form and one time by vein (intravenous form). The amount of CP-690,550 available in the blood following administration by vein will be measured and is expected to reflect the maximum amount possible for the 10 mg CP-690,550 dose. The amount of CP-690,550 that is achieved in the blood following oral tablet administration will also be measured and compared to that achieved following administration by vein in order to estimate how much of the maximum amount possible is actually absorbed into the blood following administration by mouth as a tablet.

Detailed description: To estimate the absolute bioavailability of a 10 mg oral dose of tasocitinib (CP-690,550) compared to a 10 mg intravenous dose of tasocitinib (CP-690,550) in healthy subjects.

Eligibility criteria: Inclusion Criteria:

* Healthy male and/or female (non childbearing potential)
* Subjects between the ages of 21 and 55 years, inclusive
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs)
* No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB)

Exclusion Criteria:

* Evidence or history of any clinically significant illness, medical condition, or disease.

  2. Evidence or history of any clinically significant infections within the past 3 months.

  3. Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day.

Primary outcomes:
measure: AUCinf of tasocitinib (CP 690,550)
timeFrame: PK blood samples out to 12 hours post dose
Secondary outcomes:
measure: AUClast, Cmax, Tmax, and t½, CL (IV dose only) and Vss (IV dose only) of tasocitinib (CP 690,550).
timeFrame: PK blood samples out to 12 hours postdose
measure: Safety Laboratory tests: hematology, chemistry, urine testing
timeFrame: Safety Laboratory testing performed out to 2 days post last dose
measure: Vital Signs: Blood pressure, heart rate, oral temperature
timeFrame: Vital signs out to 2 days post last dose
measure: AE Reporting
timeFrame: Throughout study
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT06271005: Neurological Dry Eye Study Stimulating Both Lacrimal and Vagus Nerves
Official title: Neurological Dry Eye Study Stimulating Both Lacrimal and Vagus Nerves
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dry Eye Disease
Dry Eye
Keywords: vagus nerve
Ehlers-Danlos Syndrome
EDS
lacrimal nerves
dry eye
tear production
dysautonomia
POTS
Postural Orthostatic Tachycardia Syndrome
constipation
gastroparesis
tachycardia
NeuroTears
Mast Cell Activation Syndrome
vagus nerve stimulation
MCAS
Post-COVID
COVID
Longhaulers
Lead sponsor: Genetic Disease Investigators
Sponsor class: OTHER
First posted: 2024-02-21
Enrollment: 75
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a study on neurological dry eye disease, focusing on a patented over-the-counter supplement supporting tear production neurologically, including the lacrimal and vagus nerves.

Detailed description: Chronic inflammation is implicated in the majority of chronic dry eyes. The parasympathetic nervous system is responsible for both basal tear secretion (the aqueous layer) by the lacrimal functional unit, and is responsible for controlling many aspects of chronic inflammation via the vagus nerve.

This study will document its effects on dry eyes, in addition to other symptoms/signs of low parasympathetic nervous system functioning using an over-the-counter supplement.

Eligibility criteria: Inclusion Criteria:

* Must have dry eye (OSDI score 30 and above)
* Tear break up time of less than or equal to 7 seconds
* Must be able to come for baseline tests and again at 4 weeks

Exclusion Criteria:

* Demodex
* Corneal scarring
* must not take Physostigmine (glaucoma), Pyridostigmine (Mestinon), Neostigmine (for Myasthenia Gravis); Aricept (for Alzheimer's), or ingredients to NeuroTears
* No known allergies to ingredients in NeuroTears

Primary outcomes:
measure: OSDI
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06723405: Efficacy Study of EVO301 in Moderate to Severe Atopic Dermatitis
Official title: A Randomized, Double-blind, Placebo-controlled, Proof-of-concept Study of EVO301 in Adults with Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Atopic Dermatitis (AD)
Eczema
Eczema Atopic Dermatitis
Keywords: atopic dermatitis
eczema
Lead sponsor: Evommune, Inc.
Sponsor class: INDUSTRY
First posted: 2024-12-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a Phase 2a efficacy and safety study of EVO301 for the treatment of adults with atopic dermatitis.

Detailed description: This is a Phase 2a efficacy and safety study of intravenous EVO301 in adults with moderate to severe atopic dermatitis.

Eligibility criteria: Inclusion Criteria:

1. Males or non-pregnant, non-lactating females, age 18 years or older
2. Chronic atopic dermatitis for at least 6 months
3. BSA of AD involvement of at least 10%
4. EASI score of at least 16.

Exclusion Criteria:

1. Significant AD flare with 4 weeks
2. Use of biologic therapy within 12 weeks
3. Regular use of tanning booth within 4 weeks
4. Skin condition that could interfere with study assessments

Primary outcomes:
measure: Eczema Area and Severity Index (EASI)
timeFrame: 12 weeks
Secondary outcomes:
measure: Investigator Global Assessment (IGA)
timeFrame: 12 weeks
measure: Body Surface Area (BSA)
timeFrame: 12 weeks
measure: Pruritus-NRS
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Coorparoo
country: Australia
facility: Cornerstone Dermatology
city: Darlinghurst
country: Australia
facility: Momentum Clinical Research Darlinghurst
city: Auckland
country: New Zealand
facility: Pacific Clinical Research Network (PCRN) Auckland
city: Auckland
country: New Zealand
facility: Optimal Clinical Trials North
city: Auckland
country: New Zealand
facility: Optimal Clinical Trials
city: Christchurch
country: New Zealand
facility: Pacific Clinical Research Network (PCRN) Christchurch
city: Dunedin
country: New Zealand
facility: Momentum Clinical Research Dunedin
city: Hamilton
country: New Zealand
facility: Clinical Trials New Zealand Ltd
city: Hutt Central
country: New Zealand
facility: Momentum Clinical Research Lower Hutt
city: Nelson
country: New Zealand
facility: Pacific Clinical Research Network (PCRN) Tasman
city: Paraparaumu
country: New Zealand
facility: Momentum Clinical Research Kapiti
city: Pukekohe
country: New Zealand
facility: Momentum Clinical Research Pukekohe
Study officials:
References:
Clinical trial NCT04922905: Nervous System Symptoms Associated With COVID 19
Official title: Nervous System Symptoms Associated With COVID 19 : NS-COV
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
Keywords: Nervous system
coronavirus
SARS-CoV-2
Nervous system symptoms
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2021-06-11
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: This is an observational, prospective, cross-sectional and monocentric cohort study
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study aim to prospectively evaluate the neuropsychiatric symptoms of patients infected with the SARS-CoV-2 virus by a standardized neuropsychiatric examination : the global CASE scale (Clinical Assessment Scale in Autoimmune Encephalitis), and the prevalence of disturbances of consciousness, focal neurological deficit, cognitive impairment, headache, anosmia, sleep disturbances, impaired autonomic nervous system and peritraumatic stress.


Eligibility criteria: Inclusion Criteria:

* Being hospitalized at the Toulouse University Hospital for a COVID-19 infection proven by a probable PCR or COVID-type examination on the chest scan
* Have given oral consent for the collection of clinical neurological data
* Be in a clinical state compatible with a 30-minute neurological examination
* Be French-speaking
* Be affiliated to a Social Security scheme

Exclusion Criteria:

* Refusal of the neurological examination
* History of neurological pathology at a severe stage
* Pregnant or breastfeeding woman
* Persons with tutors or curators

Primary outcomes:
measure: percentage of patients in the Neuro + and Neuro- groups
timeFrame: Baseline T0 : inclusion visit
Secondary outcomes:
Other outcomes:
Locations:
city: Toulouse
country: France
facility: CHU Toulouse
Study officials:
affiliation: University Hospital, Toulouse
name: Marie Rafiq, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01318005: Oral Contraceptive (OC) Estrogen Dose and Breast Proliferation
Official title: The Effects of Dose and Formulation of Oral Contraceptives (OCs) on Breast-Cell Proliferation: Can the Chemopreventive Effects of OCs on Endometrial and Ovarian Cancer be Extended to Breast Cancer?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Oral Contraceptive
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2011-03-18
Enrollment: 85
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this research study is to gain a better understanding of the changes that may occur in the breast when a woman uses an oral contraceptive (birth control pill). Some research indicates that women who use birth control pills with lower amounts of estrogen (a hormone in the birth control pill) may have lower breast cell growth than women who use birth control pills with a higher amount of estrogen; this research will examine that in detail. This research will also test whether the results found in HS-07-00269 can be confirmed.


Eligibility criteria: Inclusion Criteria:

1. Age 18-35
2. BMI \<30 kg/m2
3. Premenopausal with regular cycles or currently taking an OC
4. Not currently or recently pregnant or nursing (within previous 6 months)
5. Non-smoker
6. No use of antibiotics within the prior 4 weeks
7. Competent to provide written informed consent (as judged by study team)
8. Willing to adhere to the OC regimen
9. Willingness to refrain from the use of aspirin or NSAIDS 10 days pior to the biopsy appointment and one week following the biopsy procedure
10. Willing and able to refrain from use of fish oils 10 days prior to the biopsy appointment and one week following the biopsy procedure

Exclusion Criteria:

1. Diabetes
2. Abnormal breast examination
3. Abnormal PT/INR and/or CBC with platelets test results (as determined by one of the study physicians)
4. History or current therapeutic or prophylactic use of anticoagulants
5. Known bleeding disorder or history of unexplained bleeding or bruising
6. History of breast cancer or previous diagnostic breast biopsy
7. Known allergy to local anesthetic

Primary outcomes:
measure: To measure breast cell proliferation levels between the three oral contraceptive dose groups.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC University Hospital
state: California
Study officials:
affiliation: University of Southern California
name: Heather MacDonald, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00148005: Prevalence, Etiology and Therapy of Micturition Disorders of Children With a Mental and/or Motoric Disability
Official title: Prevalence, Etiology and Therapy of Micturition Disorders of Children With a Mental and/or Motoric Disability
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Micturition Disorder
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2005-09-07
Enrollment: 250
Sex: ALL
Minimum age (years): 4
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Investigation of the prevalence etiology and therapy of micturition disorders of children with a mental and/or motoric disability

Detailed description: Overview of the problem by a questionnaire, diary of micturition and drinking behaviour, filled out by the parents or by the staff of the institution.

Investigation of the etiology by clinical and functional examination (uroflowmetry, bladder scan, video-urodynamic examination).

Frequency:

* Uroflowmetry: two periods of two weeks, with 6 weeks break between both periods. During the follow-up period every 3 months during 12 months
* Bladder scan: once during the periods of the uroflowmetry
* Video-urodynamic examination: once in selected participants, after consent of the parents
* Adaptation of the drinking behaviour: start after two weeks of observation, after uroflowmetry and bladder scan. Continuous proces.
* Therapeutic measures (medication, miction clock): start after 10 weeks of observation or after video-urodynamic examination.

Development of a therapeutic plan: adaptation of the micturition and drinking behaviour, anticholinergic therapy.

Eligibility criteria: Inclusion Criteria:

* Children with a motoric and/or mental disability
* 4-14 years

Exclusion Criteria:

* Known neurogenic bladder disorder

Primary outcomes:
measure: Prevalence of micturition disorders
measure: Etiology of micturition disorders after 10 weeks observation
measure: Influence of drinking scheme on bladder capacity and micturition continence after 10 weeks observation
Secondary outcomes:
measure: Efficacy of the therapy after 3, 6, 9, 12 months
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Erik Van Laecke, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01561105: Improving Depression Care for Elders: Coordinating Center
Official title: This Was a Five-year Seven-site Trial to Study the Cost-effectiveness of a Population Based Disease Management Program for Late Life Depression in Primary Care.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depression
Dysthymic Disorder
Both Major Depression and Dysthymic Disorder
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: The John A. Hartford Foundation
name: California HealthCare Foundation
name: Hogg Foundation
name: Robert Wood Johnson Foundation
First posted: 2012-03-22
Enrollment: 1801
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Purpose: To determine the effectiveness of the Improving Mood-Promoting Access to Collaborative Treatment(IMPACT) collaborative care management program for late-life depression.

Detailed description: This study tested an organized method of delivering care for late life depression in primary care. Specifically, the investigators evaluated the effectiveness of this intervention as compared to 'care as usual'. The investigators studied the effect of the intervention on clinical outcomes such as depressive symptoms, functional status, health related quality of life. They also determined the cost-effectiveness of the intervention compared to care as usual.

Eligibility criteria: Inclusion Criteria:

* Major depression or dysthymia as diagnosed by a structured diagnostic interview.
* Patient plans to receive primary care at the study clinic for the next year.

Exclusion Criteria:

* Age under 60.
* Current symptoms or history of psychosis or mania as determined by structured diagnostic interview.
* Cognitive impairment as defined by a score less than 23 on a Mini Mental Status Examination.
* Terminal illness - defined as having a life expectancy of less than 6 months.
* Active alcohol abuse as determined by a screening interview.
* High suicide risk as determined by current plan for suicide or a history of more than 3 prior suicide attempts in the past 10 years.

Primary outcomes:
measure: Severity of depression symptoms
Secondary outcomes:
measure: Functioning
Other outcomes:
Locations:
Study officials:
affiliation: University of Washington
name: Jurgen Unutzer, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Unutzer J, Katon W, Callahan CM, Williams JW Jr, Hunkeler E, Harpole L, Hoffing M, Della Penna RD, Noel PH, Lin EH, Arean PA, Hegel MT, Tang L, Belin TR, Oishi S, Langston C; IMPACT Investigators. Improving Mood-Promoting Access to Collaborative Treatment. Collaborative care management of late-life depression in the primary care setting: a randomized controlled trial. JAMA. 2002 Dec 11;288(22):2836-45. doi: 10.1001/jama.288.22.2836.
citation: Stewart JC, Perkins AJ, Callahan CM. Effect of collaborative care for depression on risk of cardiovascular events: data from the IMPACT randomized controlled trial. Psychosom Med. 2014 Jan;76(1):29-37. doi: 10.1097/PSY.0000000000000022. Epub 2013 Dec 23.