louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03507322: Ultrasound Study by Texturization as a Predictor of Pregnancy in Oocyte Donation Programs
Official title: Ultrasound Study Through Uterine Texturization to Predict Pregnancy After Blastocyst Transfer in Patients Undergoing Hormone Replacement Therapy (HRT) Cycles With Donor Oocytes
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Infertility
Keywords: texturization
pregnancy rate
oocyte donation
2D ultrasound
3D ultrasound
assisted reproductive technology (ART)
Lead sponsor: Vida Recoletas Sevilla
Sponsor class: OTHER
First posted: 2018-04-25
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infertile women undergoing IVF/ICSI treatment

Brief summary: This study is focused on analysing the application of ultrasound scanning techniques as new biomarkers in reproductive medicine. Those biomarkers are based on the analysis of ultrasound texture in different areas of uterine tissue, using 2D/3D ultrasound scanning. Investigators will use the algorithm Text® to analyse the ultrasound texture of the endometrium and myometrium. The aim of the project is to study if it is possible to obtain measurable, objective and reproducible data in healthy volunteers which can be used to predict pregnancy and determine the best moment to perform embryo transfer in assisted reproductive technology (ART) cycles


Eligibility criteria: Inclusion Criteria:

* Body mass index (BMI) between 18 and 30 kg/m2
* Not taking the contraceptive pill in a previous cycle
* Non-pregnant: beta human chorionic gonadotropin (HCG) test with negative result at the beginning of the study)
* No previous history of inflammatory diseases, circulatory diseases, abdomen or pelvic diseases
* Physical gynecological exploration without pathological findings
* Gynecological ultrasound study of the uterus with a normal result

Exclusion Criteria:

* Ultrasound studies with technical defects in image acquisition
* Simultaneous participation in other studies
* Previous participation in other study which can affect the results of the present study

Primary outcomes:
measure: Clinical pregnancy rate
timeFrame: Around 5-6 weeks after embryo transfer
measure: Biochemical miscarriage rate
timeFrame: Up to one month after embryo transfer
measure: Clinical miscarriage rate
timeFrame: Up to 20 weeks after embryo transfer
measure: Chemical pregnancy rate
timeFrame: Around 14 days after embryo transfer
measure: beta HCG level
timeFrame: Around 14 days after embryo transfer
Secondary outcomes:
Other outcomes:
Locations:
city: Sevilla
country: Spain
facility: IVI Sevilla
Study officials:
References:
Clinical trial NCT03303222: Study to Develop a Breath Analyser to Detect Chronic Kidney Disease
Official title: Pilot Study to Develop a Breath Analyser to Detect Chronic Kidney Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Kidney Diseases
Lead sponsor: University College, London
Sponsor class: OTHER
First posted: 2017-10-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with kidney disease under the care of Royal Free Hospital

Brief summary: Measure trimethylamine oxide in the breath.

Detailed description: Organic compounds such as trimethylamine oxide (TMAO) accumulate in the blood of patients with kidney disease, and volatile compounds such as TMAO can be detected in the breath.

The investigators wish to develop a breath analyser to measure volatile compounds, such as TMAO in the breath in patients with kidney disease.

Eligibility criteria: Inclusion Criteria:

* patients with kidney disease under the care of Royal Free Hospital

Exclusion Criteria:

* patients unable to provide informed consent
* patients unable to exhale into breath analyser

Primary outcomes:
measure: measurement of breath TMAO
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: UCL, London
name: andrew davenport, md
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06398522: Dietary Supplementation With Butyrate in Individuals With Liver Steatosis and Metabolic Syndrome
Official title: Dietary Supplementation With Butyrate in Individuals With Liver Steatosis and Metabolic Syndrome: a Randomized Double-blind Placebo-controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: NAFLD
Metabolic Syndrome
Lead sponsor: University of Bologna
Sponsor class: OTHER
First posted: 2024-05-03
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This was a double-blind, randomized, placebo-controlled clinical study aiming to assess the effect of a food for special medical purposes with functional release containing calcium butyrate, zinc gluconate and vitamin D3 on liver steatosis in individuals with NAFLD and metabolic syndrome


Eligibility criteria: Inclusion criteria:

* 40-75 years of age
* Caucasian ethnicity
* NAFLD
* Metabolic Syndrome

Exclusion criteria:

* acute and chronic gastrointestinal disorder not controlled by stable treatment since at least 3 months
* serious or disabling diseases (e.g. severe organ failure, malignancy or dementia)
* obesity (body mass index (BMI)\> 30 Kg/m2)
* type 1 and 2 diabetes
* alcoholism
* pregnancy and breastfeeding
* any medical or surgical condition making complex or inconstant the adhesion to the study protocol

Primary outcomes:
measure: Effect on Fatty Liver Index
timeFrame: 3 months
Secondary outcomes:
measure: Effect on Hepatic Steatosis Index
timeFrame: 3 months
measure: Effect on Lipid Accumulation Product
timeFrame: 3 months
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: University of Bologna
state: BO
Study officials:
affiliation: University of Bologna
name: Claudio Borghi
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02528422: The Effect of Acyl-Ghrelin on Kidney Function and Blood Pressure in Healthy Volunteers
Official title: The Effect of Acyl-Ghrelin on Kidney Function and Blood Pressure in Healthy Volunteers - A Randomized, Cross-over, Single-blind, Placebo-controlled Dose-response Study of the Acyl-ghrelin Induced Effects on GFR, Tubular Transport of Sodium and Water in Different Nephron Segments and Central and Peripheral Blood Pressure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Renal Tubular Transport
Lead sponsor: Regional Hospital Holstebro
Sponsor class: OTHER
Collaborators: name: University of Aarhus
First posted: 2015-08-19
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Ghrelin (growth hormone release inducer) is produced in the stomach. The active form of Ghrelin is Acyl-Ghrelin. Acyl-Ghrelin stimulates the Ghrelin receptors. Ghrelin receptors are detected in the distal tubules in mice and animal studies have shown that Ghrelin increases the absorption of sodium in the renal tubules. Ghrelin infusion directly into the renal artery of rats increased sodium reabsorption in the distal nephron, presumably via the epithelial sodium channels (ENaC).

The purpose of the study is to measure the acyl-ghrelin induced effects on GFR, tubular transport of sodium and water in different nephron segments and central and peripheral blood pressure in a randomized, cross-over, single-blind, placebo-controlled dose-response study.


Eligibility criteria: Inclusion Criteria:

* Age 18-40 years,
* BMI 18,5-30kg/m2,
* women must use contraception.

Exclusion Criteria:

* Tobacco smoking,
* substance abuse,
* consumption of more than 7 units of alcohol/week for women and more than 14 units/week for men,
* medical treatment except for contraception,
* pregnancy or nursing,
* allergy to acyl-ghrelin,
* significant clinical signs of heart-, lung-, liver-, kidney-, endocrine-, brain- or neoplastic disorders,
* clinically significant abnormal findings in screening blood samples,
* urine sample or ECG,
* office blood pressure over 140/90 mmHg,
* donation of blood within 1 month of the first day of investigation.

Primary outcomes:
measure: Fractional sodium excreation (FENa)
timeFrame: 5-6 Hours
Secondary outcomes:
measure: Renal function
timeFrame: 5-6 Hours
measure: Water and sodium transport
timeFrame: 5-6 Hours
measure: Vasoactive hormones
timeFrame: 5-6 Hours
measure: Blood pressure
timeFrame: 5-6 Hours
Other outcomes:
Locations:
city: Holstebro
country: Denmark
facility: Department of Medical Research, Regional Hospital Holstebro
Study officials:
affiliation: Department of Medical Research and Medicine, Holstebro Regional Hospital
name: Erling B Pedersen
role: STUDY_CHAIR
References:
Clinical trial NCT02586922: Fetal Lung Volume and Pulmonary Artery Resistance Index Measurement in Term Diabetic Pregnancy
Official title: Fetal Lung Volume and Pulmonary Artery Resistance Index Measurement in Term Diabetic Pregnancy and Their Correlation With Neonatal Outcome: a Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Distress Syndrome
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2015-10-27
Enrollment: 70
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This is a prospective observational study which will be carried out at Ain Shams University Maternity Hospital, Obstetrics and Gynecology department, Faculty of Medicine, Ain Shams University, from December 2015 to December 2016.

Diabetic pregnant women 38 weeks gestation admitted for elective termination by Caesarian section due to various obstetric indications

Brief summary: The aim of this study is to determine cut-off values for fetal lung volume by VOCAL and pulmonary artery resistance index by pulsed Doppler in fetuses of diabetic mothers, and correlate the results with postnatal respiratory distress of the term neonates.

Detailed description: Research question:

Can the assessment of fetal lung volume by Virtual Organ Computed-aided Analysis (VOCAL) and pulmonary artery resistance index by pulsed Doppler predict neonatal respiratory distress syndrome in term fetuses of diabetic mothers?

Research hypothesis:

The assessment of fetal lung volume by VOCAL and pulmonary artery resistance index by pulsed Doppler can predict neonatal respiratory distress syndrome in term fetuses of diabetic mothers.

Eligibility criteria: Inclusion Criteria:

-Diabetic pregnant women 38 weeks gestation admitted for elective termination due to various obstetric indications

Exclusion Criteria:

1. Twins.
2. Pregnancy complicated by medical disorders other than Diabetes Mellitus (hypertension, pre-eclampsia, cardiac disorders, thyroid disorders, anemia with pregnancy...etc).
3. Autoimmune disorders.
4. Congenital fetal anomalies.
5. Macrosomia and intrauterine growth restriction (IUGR).
6. Intrauterine fetal death (IUFD).
7. Amniotic fluid index \<5cm or \>20cm.
8. Patients taking steroids within one week of measurement of lung volume.

Primary outcomes:
measure: neonatal respiratory distress
timeFrame: immediately after delivery
Secondary outcomes:
measure: • Neonatal mortality rate
timeFrame: One week after delivery
Other outcomes:
Locations:
Study officials:
affiliation: Ain Shams University
name: Mohamed Laban, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00924222: Organ Protection With Sevoflurane Postconditioning After Cardiac Surgery With Cardiopulmonary Bypass
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac On-pump Surgery
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2009-06-18
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Organ protection, volatile anesthetics, postconditioning.

Sedation of patients on ICU after cardiac surgery with cardiopulmonary bypass with either propofol or sevoflurane. Evaluation of organ function and inflammatory mediators in the blood.


Eligibility criteria: Inclusion criteria:

* CABG and/or heart valve surgery with CPB
* Ejection fraction (EF) = 30%
* Canadian Cardiovascular Society (CCS) classification = 3
* Ages 18 to 90 years old

Exclusion criteria:

* Pulmonary disease: forced expiratory volume in one second (FEV1) \< 80%; FEV1/forced vital capacity (FVC) \< 70%
* Renal disease and/ or creatinine-clearance \< 60 ml/min
* Previous cardiac surgery
* Emergency procedures
* Postoperative intra aortic balloon pump (IABP) requirement
* Myocardial infarction \< 7d
* Steroid treatment
* Insulin-dependent diabetes
* Pregnancy

Primary outcomes:
measure: Myocardial injury markers (myoglobin, creatine kinase, myocard specific creatine kinase, and troponin T)
timeFrame: Start and end of ICU stay
Secondary outcomes:
measure: Oxygenation index, postoperative pulmonary complications, ICU stay (days), length of hospitalisation
timeFrame: Start with surgery until end of hospitalisation
Other outcomes:
Locations:
city: Zurich
country: Switzerland
Study officials:
affiliation: UniversitaetsSpital Zuerich
name: 01 Studienregister MasterAdmins
role: STUDY_DIRECTOR
References:
citation: Steurer MP, Steurer MA, Baulig W, Piegeler T, Schlapfer M, Spahn DR, Falk V, Dreessen P, Theusinger OM, Schmid ER, Schwartz D, Neff TA, Beck-Schimmer B. Late pharmacologic conditioning with volatile anesthetics after cardiac surgery. Crit Care. 2012 Oct 14;16(5):R191. doi: 10.1186/cc11676.
Clinical trial NCT01034722: Fat Globules in Breast Milk
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Fat Globules in Breast Milk
Keywords: Breast Milk
Fat Globules
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2009-12-17
Enrollment: 45
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Sampling method: PROBABILITY_SAMPLE
Study population: Study population will include 45 volunteer mothers, that will divide to 3 groups: 15 vegetarians, 15 western diet and 15 Bedouins.

Each participant will be nursing a 2-5 months baby.

Brief summary: The aims of this study is:

1. To investigate the diet influence on size and composition of fat globules in breast milk under controlled diet.
2. To study the changes in globules distribution along one session of lactation and during the day.

Study design:

Subjects:

This will be a open label study. Each subject will serve as his own control. Study population will include 45 volunteer mothers, that will divide to 3 groups: 15 vegetarians, 15 western diet and 15 Bedouins.

Each participant will be nursing a 2-5 months baby. Each participant will sign an informed consent. Each participant will be ask to collect 2 milk samples twice a day i.e.- once on the first nursing in the morning (in the beginning and at the end of the nursing session), and once in the evening on last nursing again, (in the beginning and at the end). Each sample will contain 5 ml of milk.

Participants will be asked to repeat the procedure one month later.


Eligibility criteria: Inclusion Criteria:

* Healthy Volunteers nursing only babies aged 2-5 months.
* Age: 20-45 years old.
* Written informed consent.

Exclusion Criteria:

* Nursing babies more than 5 months or less than 2 months.
* Infants who consume breast milk replacement formulas on top of breast milk.

Primary outcomes:
measure: To investigate the diet influence on size and composition of fat globules in breast milk under controlled diet.
measure: To study the changes in globules distribution along one session of lactation and during the day.
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Tel Aviv Medical Center
Study officials:
References:
Clinical trial NCT01916122: Fluorestradiol (FES) PET/CT for Imaging Estrogen Receptor Status
Official title: Fluorestradiol (FES) PET/CT for Imaging Estrogen Receptor Status
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Breast Cancer
Keywords: Fluorestradiol (FES)
PET/CT scan
Estrogen Receptor
13-071
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2013-08-05
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: These are tumors which expresses estrogen receptors. Estrogen receptors are found within breast cancer cells and are an important marker of which medicines may best treat a breast cancer. This study is being performed to imaging the amount of estrogen receptors expressed in the tumor. A research agent named 16α-18F-fluoroestradiol (FES) finds estrogen receptors and binds to them. Then tumors with estrogen receptors can be imaged by a PET/CT scanner, a machine that can take pictures of where the FES is and how much FES is present. The results of this study may help researchers know whether FES can be used to monitor changes in estrogen receptors in tumors during treatment.


Eligibility criteria: Inclusion Criteria:

* Patients with histologic/immunochemical proof of ER+ primary or metastatic malignancy (positive staining in ≥ 1% of cells by immunohistochemistry).
* Patients who are to be treated with clinically approved or experimental regimens where ER has an important role
* ECOG performance status of 0-2.
* Patients must provide written informed consent

Exclusion Criteria:

* Age \<18 years
* Patients who cannot undergo PET/CT scanning (i.e. because of weight limits, claustrophobia)
* Pregnancy or lactation
* Total serum bilirubin \> 1.5 times upper limit of normal (abnormal hepatic metabolism may interfere with FES hepatic excretion). Increased serum bilirubin due to Gilbert's syndrome is permitted.
* Serum creatinine \> 1.5 times upper limit of normal.

Primary outcomes:
measure: FES PET/CT scanning
timeFrame: 5 years
Secondary outcomes:
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: Randy Yeh, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01394822: Neuromuscular Ultrasound for Focal Neuropathies
Official title: Neuromuscular Ultrasound for Focal Neuropathies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Focal Neuropathies
Carpal Tunnel Syndrome
Cubital Tunnel Syndrome
Median Neuropathy
Ulnar Neuropathy
Peroneal Neuropathy
Radial Neuropathy
Sciatic Neuropathy
Tibial Neuropathy
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2011-07-14
Enrollment: 120
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: Individuals presenting to the Diagnostic Neurology Laboratory at Wake Forest Baptist Medical Center for evaluation of focal nerve disease.

Brief summary: The purpose of this study is to determine if a new diagnostic technique, called neuromuscular ultrasound, can improve our ability to diagnose focal nerve disease.


Eligibility criteria: Inclusion Criteria:

* Electrodiagnostic finding of focal nerve disease
* Age 18 and older

Exclusion Criteria:

* Skin lesions preventing ultrasound
* Known ultrasound gel allergy
* Unable to complete 6 months of follow-up

Primary outcomes:
measure: Overall Neuropathy Sum Score
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Medical Center
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Michael S Cartwright
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mandeville R, Wali A, Park C, Groessl E, Walker FO, Cartwright MS. Cost-effectiveness of neuromuscular ultrasound in focal neuropathies. Neurology. 2019 Jun 4;92(23):e2674-e2678. doi: 10.1212/WNL.0000000000007602. Epub 2019 May 3.
Clinical trial NCT00527839: Hospital for Special Surgery Shoulder Arthroplasty Cohort
Official title: Prospective Evaluation of the Clinical and Economic Outcomes of Total Joint Replacement: HSS Shoulder Arthroplasty Cohort
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Shoulder Arthroplasty
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
First posted: 2007-09-11
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We will be asking all patients undergoing a total shoulder arthroplasty to participate.

Brief summary: Total joint replacements are some of the most successful medical devices developed over the last fifty years. They enable millions of people to remain ambulatory and pain free, with minimal risk. In 2002, over 200,000 total hip replacements, 350,000 total knee replacements, and 25,000 total or partial shoulder replacements were performed in the United States (HCUP data). Future use will likely be even higher: it is estimated that by the year 2020, the population 65 and over in developed countries will increase by 71%. Existing studies do not provide adequate prospective data to evaluate long-term outcomes.

HSS is a world leader in total joint replacement including total shoulder arthroplasty. However, there is no systematic follow-up or evaluation of patients who have their shoulders replaced here.

The purpose of this study is to establish a prospective cohort of HSS total shoulder arthroplasty to evaluate predictors of outcome, causes of failure and to allow ongoing evaluation of the results of our patients over time.


Eligibility criteria: Inclusion Criteria:

* 18 years or older and undergoing total shoulder arthroplasty at HSS

Exclusion Criteria:

* No other exclusion criteria. Pregnant women are eligible for the registry as this is a non-interventional study which only involves filling out questionnaires.

Primary outcomes:
measure: Patient Reported Outcome Measures (PROMs)
timeFrame: Collection of at Baseline, 6 Months, 1 Year, 2 Year, 5 Year and 10 Year
measure: Intra Operative Data
timeFrame: Collection of data on Day 0 (Date of Surgery)
measure: Demographic data
timeFrame: Collection of at Baseline, 6 Months, 1 Year, 2 Year, 5 Year and 10 Year
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
Study officials:
affiliation: Hospital for Special Surgery, New York
name: Robert Marx, MD
role: PRINCIPAL_INVESTIGATOR
References: