louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02301637: Eeva System Imaging Study
Official title: Prospective Observational Study Utilizing the Eeva™ System 2.2.1 for Ongoing Collection of Development and Validation Data
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infertility
Lead sponsor: Progyny, Inc.
Sponsor class: INDUSTRY
First posted: 2014-11-26
Enrollment: 500
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing in vitro fertilization treatment who fulfill all eligibility criteria.

Brief summary: The purpose of this clinical trial is to collect imaging data on embryos followed to blastocyst stage (Day 5-6) for ongoing development and validation of the Eeva System.

Detailed description: The purpose of this clinical trial is to collect imaging data on embryos followed to blastocyst stage (Day 5-6) for ongoing development and validation of the Eeva System.

Primary Objectives Include:

To collect imaging data on embryos followed to blastocyst stage (Day 5-6)

Secondary Objectives Include:

To collect enrollment data: demographics, IVF and pregnancy history To collect Day 3, Day 5 and Day 6 embryo morphology data To collect pregnancy test and outcome data To collect pre-implantation genetic screening (PGS) data (if applicable) To collect Frozen Embryo Transfer (FET) data (if applicable)

Eligibility criteria: Inclusion Criteria:

* At least 18 years of age
* Women undergoing in vitro fertilization treatment using their own eggs
* Fresh or Frozen Blastocyst (Day 5-6) transfer
* At least 5 diploid (2PN) embryos at fertilization check
* Willing to have all 2PN embryos imaged by Eeva
* Willing to comply with study protocol and procedures
* Willing to provide written informed consent

Exclusion Criteria:

* Freeze-all due to ovarian hyperstimulation syndrome (OHSS)
* Use of donor egg / gestational carrier
* Fertilization using surgically removed sperm
* History of cancer
* Assisted Hatching (AH) on Day 3

Primary outcomes:
measure: Adverse events and device malfunctions will be reported and summarized from the point of Eeva imaging through study exit.
timeFrame: 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: FCI (River North)
state: Illinois
city: Carmel
country: United States
facility: Midwest Fertility Specialists
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Austin
country: United States
facility: Texas Fertility Center
state: Texas
city: Houston
country: United States
facility: Houston Fertility Institute
state: Texas
city: Seatlle
country: United States
facility: Seattle Reproductive Medicine
state: Washington
city: Wellington
country: New Zealand
facility: Fertility Associates
Study officials:
affiliation: Vice President, Scientific and Medical Affairs
name: Sheua Shen, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01220037: Resistance Exercise in Healthy Men
Official title: The Effect of Age and Dietary Protein Intake on Myocellular Characteristics Following a Single Bout of Resistance Exercise in Healthy Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Single Bout of Resistance Type Exercise
Standardized Diet
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2010-10-13
Enrollment: 34
Sex: MALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: In the present study, the effects of age and dietary intake will be assessed on myocellular characteristics during 72 hours after a resistance type exercise session.


Eligibility criteria: Inclusion Criteria:

* healthy men between the ages of 18-30 or 70-85 years

Exclusion Criteria:

* Subjects with a recent history or current state of cardiovascular disease, COPD, Parkinson, rheumatoid arthritis, musculoskeletal/orthopaedic disorders, renal disorder, cognitive impairment.

Primary outcomes:
measure: Muscle fiber myonuclear and stem cell content
timeFrame: baseline
measure: Muscle fiber myonuclear and stem cell content
timeFrame: 12 hours after a single bout of resistance type exercise
measure: Muscle fiber myonuclear and stem cell content
timeFrame: 24 hours after a single bout of resistance type exercise
measure: Muscle fiber myonuclear and stem cell content
timeFrame: 48 hours after a single bout of resistance type exercise
measure: Muscle fiber myonuclear and stem cell content
timeFrame: 72 hours after a single bout resistance type exercise
Secondary outcomes:
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Centre
state: Zuid Limburg
Study officials:
References:
citation: Snijders T, Verdijk LB, McKay BR, Smeets JS, van Kranenburg J, Groen BB, Parise G, Greenhaff P, van Loon LJ. Acute dietary protein intake restriction is associated with changes in myostatin expression after a single bout of resistance exercise in healthy young men. J Nutr. 2014 Feb;144(2):137-45. doi: 10.3945/jn.113.183996. Epub 2013 Dec 4.
Clinical trial NCT03396237: Vitamin D Deficiency Among Women With Unexplained Infertility
Official title: Vitamin D Deficiency Among Women With Unexplained Infertility
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Case Control Study
Lead sponsor: Ain Shams Maternity Hospital
Sponsor class: OTHER
First posted: 2018-01-10
Enrollment: 108
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Mid aged women with unexplained infertility group and another fertile group to compare vitamin D inbetween them

Brief summary: Does vitamin D is more deficient in women with unexplained infertility than in fertile pregnant women or not?

Detailed description: The study will be done on women with unexplained infertility as a case group and fertile pregnant women as control group to detect if there's a difference in serum level of vitamin D between two groups which will help in the future for curing unexplained infertility women.

Eligibility criteria: Inclusion Criteria:

* women with unexplained infertility.
* pregnant fertile women as control group.

Exclusion Criteria:

* • Endocrinopathies such as (diabetes mellitus, thyroid disorders, parathyroid disorders and hyperprolactinemia), cardiovascular related diseases, severe infection, malignancies and concomitant diseases contribute to Vit D deficiency.

  * Women with ovulatory factor like PCOS,anovulation and poor ovarian reserve are excluded.
  * Women with endometriosis are excluded.
  * Women with autoimmune diseases like antiphospholipid antibodies or lupus erythematosus are excluded.
  * Documented uterine anomalies, tubal factor, cervical factor and other local causes of infertility.
  * Male factor of infertility is excluded.
  * Bone and metabolic disease, liver diseases and kidney related diseases.

Primary outcomes:
measure: Vitamin D level
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hassan tawfek office
name: Hassan T Khairy, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT04479137: Possible Predictors of Mortality Based on COVID-19 for Patients Under 50 Years Old: A Multi-Center Experience of Istanbul
Official title: Possible Predictors of Mortality Based on COVID-19 for Patients Under 50 Years Old: A Multi-Center Experience of Istanbul
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid-19
Risk Factor, Mortality
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
First posted: 2020-07-21
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who were between 18-50 years of age and were died caused by COVID-19 will be evaluated.

Brief summary: COVID-19, which emerged in China in December 2019, has become a pandemic with its spread to many countries of the world. Mortality rates of COVID-19 pandemics vary between countries. It is known that mortality based on COVID-19 is higher in old population. Therefore the aim of this study to analyze the experience of 7 governmental hospitals in terms of patient characteristics, possible risk factors of mortality based on COVID-19.

Detailed description: COVID-19, which emerged in China in December 2019, has become a pandemic with its spread to many countries of the world. Mortality rates of COVID-19 pandemics vary between countries. It is known that mortality based on COVID-19 is higher in old population. Although several factors defined to be effective on this 'age depending factors' regional differences should be assessed deeply to clarify both the etiology and epidemiology. Therefore the aim of this study to analyze the experience of 7 governmental hospitals in terms of patient characteristics, possible risk factors of mortality based on COVID-19.

Eligibility criteria: Inclusion Criteria:

* accepted to participate
* patients who were proven to have COVID-19

Exclusion Criteria:

* declined to participate
* patients whose age under 18 or more than 50 years

Primary outcomes:
measure: mortality based on COVID-19
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Kanuni Sultan Suleyman Training and Research Hospital
Study officials:
References:
Clinical trial NCT05918237: Pilot Study to Test the Effects of Arctiva on Mild to Moderate Eczema
Official title: Pilot Study to Test the Effects of Arctiva on Mild to Moderate Eczema
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atopic Dermatitis Eczema
Lead sponsor: ClinOhio Research Services, LLC
Sponsor class: INDUSTRY
Collaborators: name: Arctiva Wellness LLC
First posted: 2023-06-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open label, single arm
Primary purpose: TREATMENT

Brief summary: Up to 30 participants with mild to moderate atopic dermatitis/eczema will be enrolled to apply study Investigational Product for 4 weeks.

Detailed description: This will be a 4-week single arm study. This study will be executed by one clinical research company in one research center accruing 30 subjects with mild to moderate Eczema/atopic dermatitis. Patients ages 18-75, will be enrolled. Subjects that are enrolled will be placed on Locus's Over The Counter cream "Arctiva" twice per day for 4 weeks.

Eligibility criteria: Inclusion Criteria:

* Male and Female;18-75 years of age
* Have a clinical diagnosis of Mild to Moderate Eczema or Atopic Dermatitis
* Signed and dated written informed consent in accordance with Good Clinical Practice (GCP) and local legislation prior to the start of any screening procedure

Exclusion Criteria:

* Patients using topical corticosteroids steroidal creams and other agents within 7 days prior to first dose of trial Eczema treatment.
* Use of systemic corticosteroids or other agents for atopic dermatitis within 4 weeks prior to first dose of trial treatment.
* Active bacterial, viral, or fungal skin infections

Primary outcomes:
measure: Severity Scoring of Atopic Dermatitis Index (SCORAD) improvement [Timeframe : Baseline to Day 28]
timeFrame: 28 Days
Secondary outcomes:
measure: Change from Baseline in Dermatology Life Quality Index (DLQI) [Timeframe: Baseline to Day 28]
timeFrame: 28 Days
measure: Change from baseline in Patient-Oriented Eczema Measure (POEM). [ Time Frame: Baseline and 28 Days]
timeFrame: 28 Days
Other outcomes:
Locations:
city: Columbus
country: United States
facility: ClinOhio Research Services, LLC
state: Ohio
Study officials:
References:
Clinical trial NCT01637337: Laparoscopic Pyelolithotomy Versus Percutaneous Nephrolothotomy for Management of >3cm Renal Pelvis Stone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Renal Pelvis Stone >3cm
Lead sponsor: Shiraz University of Medical Sciences
Sponsor class: OTHER
First posted: 2012-07-11
Enrollment: 60
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the outcome of laparoscopic pyelolithotomy with percutaneous nephrolithotomy in patients with \>3cm renal pelvis stone.


Eligibility criteria: Inclusion Criteria:

* Adults with \>3cm renal pelvis stone

Exclusion Criteria:

* History of previous surgery on the target kidney
* Active UTI
* Coagulopathy

Primary outcomes:
measure: Stone free rate
timeFrame: at least 6 month after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Shiraz
country: Iran, Islamic Republic of
facility: Shiraz University of Medical Sciences
state: Fars
Study officials:
References:
Clinical trial NCT06024837: Performance of Spectral CT-scan in Patients With Metastatic Colorectal Cancer: a Prospective Multicentre Study
Official title: Performance of Spectral CT-scan in Patients With Metastatic Colorectal Cancer: a Prospective Multicentre Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Colo-rectal Cancer
Keywords: Colo-rectal cancer
spectral CT scan
liver metastases
peritoneal carcinosis
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2023-09-06
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with synchronous or metachronous peritoneal and/or liver metastases of colorectal cancer with curative surgical plans.

Brief summary: Spectral CT is a rapidly expanding imaging modality that allows a reduction in iodine dose and irradiation compared to conventional scanning. It uses the difference in attenuation of the material according to the two different energy levels of the incident x-ray beams. The dual-energy scanner has a wide range of clinical applications, particularly in abdominal imaging.

Detailed description: First of all, the virtual creation of mono-energy images between 40 and 140 keV has shown subjective and objective improvement of tumor detection of hypovascular lesions using low energies (40keV). It has been shown to be of interest in vascular and cardiac imaging, and to reduce artefacts in bone imaging. However, its performance in oncology analysis has been little studied. The selection of patients for peritoneal and hepatic carcinosis surgery is fundamental, as surgery allows a prolongation of survival, but are associated with a non-negligible morbi-mortality rate.

Spectral CT provides improved detection of peritoneal carcinosis and liver metastases of colorectal cancer compared to conventional CT acquisition.

Eligibility criteria: Inclusion Criteria:

* Patients followed for colorectal cancer with synchronous or metachronous liver metastases and/or peritoneal carcinosis
* Patients with a curative surgical resection plan

Exclusion Criteria:

* Patients with non-metastatic colorectal cancer
* Patients treated with chemotherapy without surgical plans
* Patients with colorectal cancer with extra-hepatic and extra-peritoneal metastases alone (e.g. lung, bone)

Primary outcomes:
measure: Comparison of peritoneal lesion mapping between spectral scanning and conventional scanning
timeFrame: Year : 1
measure: Comparison of hepatic lesion mapping between spectral scanning and conventional scanning
timeFrame: Year : 1
Secondary outcomes:
measure: Evaluation of response to chemotherapy in RECIST 1.1
timeFrame: Year : 1
measure: Evaluation of response to chemotherapy in Radiomics
timeFrame: Year : 1
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: CHU Saint-Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Rémi GRANGE, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00927537: Therapy of Essential Hypertension With Kinzal®/ Kinzalplus®
Official title: Data Collection on Hypertension and Its Treatment With Kinzal®/ Kinzalplus®
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Keywords: Hypertension
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2009-06-25
Enrollment: 2052
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community

Brief summary: The efficacy and tolerability of an antihypertensive treatment with Telmisartan is followed over 3-4 months


Eligibility criteria: Inclusion Criteria:

* Hypertensive patients seen by the physician requiring antihypertensive treatment

Exclusion Criteria:

* According to the local drug information

Primary outcomes:
measure: Blood pressure
timeFrame: After 1-2 weeks, 1month, 3-4 months
Secondary outcomes:
measure: Change in Mean heart rate (bpm)
timeFrame: Baseline and 3-4 month
measure: Change in Mean Weight (kg)
timeFrame: Baseline and 3-4 month
measure: Change in Mean laboratory parameters (total cholesterol, LDL, HDL, triglyceride, fasting blood glucose)
timeFrame: Baseline and 3-4 month
measure: Patient Medical History: Duration of hypertension, Pre-treatment of hypertension, Comorbidities and Concomitant treatment
timeFrame: Baseline
measure: Final evaluation of efficacy (very good, good, sufficient, insufficient) and tolerability (very good, good, sufficient, insufficient) of treatment by the physician.
timeFrame: After 3-4 month
Other outcomes:
Locations:
city: Many Locations
country: Switzerland
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00406237: Pharmacokinetic Study Of Tigecycline In Adult Subjects With Primary Biliary Cirrhosis
Official title: Open Label, Single Dose Study Of The Pharmacokinetics Of Tigecycline In Adult Subjects With Primary Biliary Cirrhosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Liver Cirrhosis, Biliary
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2006-12-04
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: Open label, single dose study of the pharmacokinetics of tigecycline in adult subjects with primary biliary cirrhosis (PBC)

Detailed description: pharmacokinetic study

Eligibility criteria: Inclusion Criteria:

* Men and nonlactating and nonpregnant women greater than or equal to 18 years of age
* Subjects with biopsy proven primary biliary cirrhosis (PBC) disease in the asymptomatic or symptomatic phase of PBC.
* Otherwise healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results (other than those associated with PBC), vital signs, and 12-lead electrocardiogram (ECG).

Exclusion Criteria:

* Subjects with a recent increase in bilirubin, bilirubin \>15 mg/dL, presence of ascites, esophageal varices, or hepatic encephalopathy.
* Any major illness that in the investigator's judgment will substantially increase the risk associated with the subject's participation in the study
* Any malignancy including hepatocellular carcinoma.

Primary outcomes:
measure: To assess the pharmacokinetics (PK) of tigecycline in subjects with cholestatic hepatic dysfunction.
timeFrame: 5 days
Secondary outcomes:
measure: To assess the safety and tolerability of single doses of tigecycline in subjects with cholestatic hepatic dysfunction.
timeFrame: 15 days
Other outcomes:
Locations:
city: St. Paul
country: United States
facility: Pfizer Investigational Site
state: Minnesota
city: Durham
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Santurce
country: Puerto Rico
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT05390437: Nutritional Intervention For The Treatment Of Uncomplicated SAM
Official title: Nutritional Intervention For The Treatment Of Uncomplicated Severe Acute Malnutrition in South Punjab Pakistan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child Nutrition Disorders
Lead sponsor: University of Veterinary and Animal Sciences, Lahore - Pakistan
Sponsor class: OTHER
Collaborators: name: University of the Punjab
First posted: 2022-05-25
Enrollment: 200
Sex: ALL
Minimum age (years): 6
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: nutritional intervention with ready to use therapeutic food (plumpy nut. by Unicef) and Prebiotics supplimentation ( Galactooligosaccarides). will be given to uncomplicated severe acute malnourished children of 06 months to 59 months of age in southern Punjab Pakistan.one group will be given Ready to use therapeutic food and placebo the other group will be given Prebiotics supplementation (Galacto oligosaccharides) with RUTF ( Ready to use therapeutic Foods).for 60 days primary out will be Mid Upper Arm Circumference \>11.5 centimetre

Detailed description: it will be a double blind Randomised Controlled trial in Out Therapeutic Program centres of Teaching Hospital of Dera Ghazi Khan Pakistan children age of 06 months to 59 months of age from the community will be screened out at health centres . Uncomplicated SAM children will be enrolled for study Before intervention there blood sample and stool sample will be sent to the labs for complete blood examination and complete stool examination.

controlled groups will be given Ready To use Therapeutic Food and Placebo (starch) 4 grams per day for 60 days Intervention group will be given Ready to use Therapeutic Food and Prebiotic ( Galactoligosaccharides 4 gram per day for 60 days

Eligibility criteria: Inclusion Criteria:

* Uncomplicated Severely Acute Malnourished Children

Exclusion Criteria:

* Severely Acute Malnourished children with complication

Primary outcomes:
measure: Nutritional cure
timeFrame: 60 Days
Secondary outcomes:
measure: Weight gain in kilograms
timeFrame: 60 Days
Other outcomes:
Locations:
city: Dera Ghazi Khan
country: Pakistan
facility: DG Khan
state: Punjab
Study officials:
affiliation: University of Punjab
name: javeria saleem, pub. health
role: PRINCIPAL_INVESTIGATOR
References: