louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03190070: Measurement of Renal Functional Reserve
Official title: Measurement of Renal Functional Reserve With Urinary Clearance of Cold Iothalamate Before and After an Oral Protein Load
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Diseases
Keywords: Renal reserve, physiological study, diagnostic testing
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2017-06-16
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Physiological study to measure the change in glomerular filtration rate after an oral protein load
Primary purpose: OTHER

Brief summary: Single arm physiological study to measure renal functional reserve as a biomarker of kidney function and health

Detailed description: The investigators will measure glomerular filtration rate using urinary clearance of cold iothalamate before and after an oral protein load in patients with chronic kidney disease and healthy volunteers.

Eligibility criteria: Inclusion Criteria:

1. Age ≥18
2. Estimated GFR \>30 mL/min/1.73m2

Exclusion Criteria:

1. Allergy to iothalamate, shellfish or iodine
2. Use of metformin or amiodarone
3. Inability to maintain a stable regimen of medications which affect GFR for \> one week prior to participation (e.g. non-steroidal anti-inflammatory drugs, angiotensin converting enzyme inhibitors, angiotensin receptor blockers)
4. Use of medications which directly affect elimination of creatinine (e.g. cimetidine and trimethoprim)
5. Acute exacerbation of asthma or chronic obstructive pulmonary disease within 3 months requiring hospitalization or oral steroid therapy
6. Inadequate intravenous access
7. Severe anemia (Hct \<21%)
8. Acute kidney injury (rise in creatinine to ≥1.5 times the previous baseline or by ≥ 0.3 mg/dL on most recent labs prior to enrollment)
9. History of contrast-induced nephropathy
10. Hyperthyroidism
11. Pheochromocytoma
12. Sickle cell disease
13. Urinary retention or incontinence
14. Status post organ transplant
15. Pregnancy or active breast feeding
16. Cognitive impairment with inability to give consent
17. Institutionalized status

Primary outcomes:
measure: Change in glomerular filtration rate after ingestion of protein
timeFrame: Single full-day clinic visit: Repeated glomerular filtration rate measurements are to be performed over the course of the day at a single study visit for each participant.
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Sushrut Waikar, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Palsson R, Waikar SS. Renal Functional Reserve Revisited. Adv Chronic Kidney Dis. 2018 May;25(3):e1-e8. doi: 10.1053/j.ackd.2018.03.001.
Clinical trial NCT00942370: Electromyographic (EMG) and Mechanomyographic (MMG) Comparison
Official title: Comparison of Electromyographic With Mechanomyographic Signals of Rectus Abdominis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stress Urinary Incontinence
Keywords: mechanography
electromyography
effort cough
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2009-07-20
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy volunteers

Brief summary: The purpose of this study is to assess the delay between the detection (by mechanomyography-MMG) of rectus abdominis contraction and the detection of cough in cough effort.


Eligibility criteria: Inclusion Criteria:

* More or equal than 18 years old
* Patient affiliated to social security or similarly regime
* Healthy volunteer
* BMI less than 30

Exclusion Criteria:

* Pregnant women and lactating mothers
* Ward of court or under guardianship
* Adult unable to express their consent or person under legal protection
* Person deprived of freedom by judicial or administrative decision
* Person hospitalized without their consent

Primary outcomes:
measure: Delay between the detection by mechanomyography (MMG) of rectus abdominis contraction and the detection of cough in cough effort
timeFrame: 2 hours
Secondary outcomes:
measure: Lower and upper spectral band frequencies values for which the majority of the MMG signal is present, thresholds for detection of rectus abdominis contraction by mechanical myography
timeFrame: 2 hours
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Clinical Investigation Center - INSERM - University Hospital of Grenoble
Study officials:
affiliation: University Hospital, Grenoble
name: Alexandre Moreau-Gaudry, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06554470: Local vs Systemic Methotrexate in Management of Uterine Ectopic Pregnancy
Official title: Local Versus Systemic Methotrexate in Management of Uterine Ectopic Pregnancy: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Local
Systemic
Methotrexate
Uterine Ectopic Pregnancy
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2024-08-15
Enrollment: 34
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to compare local and systemic methotrexate in the management of uterine ectopic pregnancy regarding the duration of beta human chorionic gonadotropin (hCG) clearance and need for further management options.

Detailed description: Ectopic pregnancy is considered a life-threatening condition which requires immediate intervention. Owing to the advancements in medical technology, ectopic pregnancy can now be diagnosed in the early stages.

Methotrexate (MTX) is an antimetabolite drug showing a competitive reversible binding concerning natural dihydrofolates and acting as an inhibitor of the dihydrofolate-reductase (DHFR), a key enzyme synthesizing the tetrahydrofolates needed for the synthesis of purine and pyrimidine rings.

Eligibility criteria: Inclusion Criteria:

* Age from 20 to 40 years.
* Women with uterine ectopic pregnancy (interstitial pregnancy, cervical pregnancy, or cesarean scar pregnancy).
* Gestational age is less than 9 weeks, the embryo size is smaller than 10 mm, and the serum beta-human chorionic gonadotropin (β-hCG) levels are less than 10,000 mIU/mL.

Exclusion Criteria:

* Patients with basal beta hCG levels less than 1500 mIU/Ml.
* Any contraindications to MTX as a hepatic disorder, renal disorder and thrombocytopenia
* Diabetes mellitus.
* Severe vaginal bleeding or hemodynamic changes or hemoperitoneum.
* History of cancer.
* Ascites.
* Pleural effusion.

Primary outcomes:
measure: Time for serum b-hCG remission
timeFrame: Post intervention for 3 months
Secondary outcomes:
measure: Success rate
timeFrame: Post intervention for 3 months
measure: Time for uterine-mass disappearance
timeFrame: Post intervention for 3 months
measure: Hospitalization time
timeFrame: 15 days after intervention
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University
state: El-Gharbia
Study officials:
References:
Clinical trial NCT06822270: Different Surgical Modalities in the Management of Pelvi-ureteric Junction Obstruction
Official title: Evaluation of Different Surgical Modalities in the Management of Pelvi-ureteric Junction Obstruction: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pelvi-ureteric Junction Obstruction
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2025-02-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study compared open pyeloplasty (OP) and laparoscopic pyeloplasty (LP) for treating Pelvi-ureteric Junction Obstruction (PUJO) in 40 patients.


Eligibility criteria: Inclusion Criteria:

* Age between 7 months and 60 years. Diagnosed with Pelvi-ureteric Junction Obstruction (PUJO). Glomerular Filtration Rate (GFR) greater than 10 ml/min. Open to both genders.

Exclusion Criteria:

* Active infection. GFR less than 10 ml/min. Presence of a single kidney. Patients with kidney or multiple congenital anomalies. Pregnancy.

Primary outcomes:
measure: Operative Success Rate
timeFrame: 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: Assuit
country: Egypt
facility: Faculty of Medicine Al-Azhar University
Study officials:
References:
citation: Bar-Sever Z, Shammas A, Gheisari F, Vali R. Pediatric Nephro-Urology: Overview and Updates in Diuretic Renal Scans and Renal Cortical Scintigraphy. Semin Nucl Med. 2022 Jul;52(4):419-431. doi: 10.1053/j.semnuclmed.2021.12.002. Epub 2022 Jan 11.
Clinical trial NCT01411670: Administration of Human Protein C Concentrates in Patients With Sepsis and Septic Shock.
Official title: Administration of Human Protein C Concentrates in Patients With Sepsis and Septic Shock: Effects on Microcirculation and Organ Function.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Sepsis
Septic Shock
Keywords: Human Protein C
Activated protein C
Microcirculation
Septic Shock
Sepsis
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2011-08-08
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: The purpose of this study is to investigate the effects on systemic hemodynamics, microcirculation and organ function of human Protein C concentrate in patients with sepsis and septic shock.

Detailed description: Sixty septic patients with plasma protein C activity \< 60 % will be enrolled in the study. Patients will be randomly allocated to be treated with either a) a continuous infusion of human Protein C concentrate at 3 UI/Kg/hr for 72 hours to reach plasma protein C activity between 70 and 120 % b)to a continuous infusion of activated protein C at 24 micrograms/Kg/hr for 96 hours, c) a standard teatment(control; each n = 20). In all groups, norepinephrine will be titrated to achieve a mean arterial pressure (MAP) between 65 and 75 mmHg. Data from right heart catheterization, from microcirculation (SDF imaging) and from organ function as well as norepinephrine requirements will be obtained at baseline and after 24, 48, 72 hours.

Eligibility criteria: Inclusion Criteria:

* Severe sepsis or septic shock with plasma activity of protein C \< 60 %

Exclusion Criteria:

* Pregnancy
* Risk of Bleeding
* Hemorragia
* age \< 18

Primary outcomes:
measure: plasma protein C activity
timeFrame: over a period of 72 hours
Secondary outcomes:
measure: sublingual microcirculatory blood flow
timeFrame: over a period of 72 hours
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Departement of Anesthesiology and Intensive Care of the University of Rome La Sapienza
Study officials:
affiliation: University of Roma La Sapienza
name: Andrea Morelli, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00202670: Diagnosis of Coronary Artery Disease in High Risk Diabetic Patients
Official title: Diagnosis of Coronary Artery Disease in High Risk Diabetic Patients :Comparison Between Stress Echocardiography and Stress Scintigraphy in the Detection of Silent Myocardial Ischemia
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Diabetes Mellitus
Keywords: coronary artery disease
stress myocardial scintigraphy
stress echocardiography
Lead sponsor: Société Française de Cardiologie
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: high risk diabetic patients

Brief summary: The aim of this study is to determine in high risk diabetics if the positive predictive value of stress echocardiography is superior to the positive predictive value of stress scintigraphy in the diagnosis of coronary stenosis \> 50%.

Detailed description: Comparison Between Stress Echocardiography and Stress Scintigraphy in the Detection of Silent Myocardial Ischemia

Eligibility criteria: Inclusion Criteria:

* type 2 diabetic patients in women\> 60 yo or men \> 55 yo, with high risk of coronary artery disease (EF \< 40%, ECG abnormalities, renal failure , 2 others risk factors of atherosclerosis)

Exclusion Criteria:

* previous documented CAD acute coronary syndrome

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Pitie Salpetriere
city: Paris
country: France
facility: Service de diabétologie - Pitié Salpêtrière
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Claude Le Feuvre, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jacqueminet S, Barthelemy O, Rouzet F, Isnard R, Halbron M, Bouzamondo A, Le Guludec D, Grimaldi A, Metzger JP, Le Feuvre C. A randomized study comparing isotope and echocardiography stress testing in the screening of silent myocardial ischaemia in type 2 diabetic patients. Diabetes Metab. 2010 Dec;36(6 Pt 1):463-9. doi: 10.1016/j.diabet.2010.06.005. Epub 2010 Sep 15.
Clinical trial NCT01358370: A Retrospective Natural History Study of Patients With Lysosomal Acid Lipase Deficiency/Wolman Phenotype
Official title: A Retrospective Natural History Study of Patients With Lysosomal Acid Lipase Deficiency/Wolman Phenotype
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lysosomal Acid Lipase Deficiency
Wolman Disease
Keywords: LAL Deficiency
LIPA
Wolman disease
Wolman Phenotype
Early Onset LAL Deficiency
Acid Lipase Deficiency
Lead sponsor: Alexion Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2011-05-23
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Deceased patients diagnosed with LAL deficiency/Wolman phenotype in 1985 or later.

Brief summary: This is a Natural History study to characterize key aspects of the clinical course of lysosomal acid lipase (LAL) deficiency/Wolman phenotype in patients.

Detailed description: The objective of this study is to characterize key aspects of the clinical course of LAL deficiency/Wolman phenotype in patients including, but not limited to, survival and growth parameters, to serve as a historical control to inform the evaluation and care of affected patients and to provide a reference for efficacy studies of enzyme replacement or other novel therapies.

Eligibility criteria: Inclusion Criteria:

* Deceased patients diagnosed with LAL deficiency/Wolman phenotype in 1985 or later provided they have required data points in their medical records.

Exclusion Criteria:

* Patients will be excluded from the study if the required data points for inclusion are not available.
* Living LAL deficiency/Wolman phenotype patients will be excluded

Primary outcomes:
measure: Time to Death
timeFrame: Up to two years.
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Siani Medical Center
state: California
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: New York
country: United States
facility: Columbia University
state: New York
city: New York
country: United States
facility: Ney York Presbyterian Hosptial
state: New York
city: New York
country: United States
facility: North Shore Long Island Jewish Medical Center
state: New York
city: Pittsburgh
country: United States
facility: Children's Hospital of Pittsburgh
state: Pennsylvania
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
city: Paris
country: France
facility: Hospital Necker- Enfants Malades
city: Genova
country: Italy
facility: Instituto Giannina Gaslini- Ospedale Pediatrico IRCCS
city: Turin
country: Italy
facility: University of Turin
city: Birmingham
country: United Kingdom
facility: Birmingham Children's Hospital NHS Foundation Trust
city: London
country: United Kingdom
facility: Kings College London
city: Manchester
country: United Kingdom
facility: Manchester Children's Hospital
Study officials:
References:
Clinical trial NCT01312870: Study of Postoperative Nutritional Support in Cardiac Surgery.
Official title: Prospective Randomized Study of Postoperative Nutritional Support in Cardiac Surgery.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Heart Diseases
Lead sponsor: Meshalkin Research Institute of Pathology of Circulation
Sponsor class: NETWORK
First posted: 2011-03-11
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether postoperative nutritional support improves postoperative outcomes in cardiac patients with malnutrition .


Eligibility criteria: Inclusion Criteria:

* Absolute lymphocyte count \< 1500
* Albumin \<35 g/L
* Body mass index\<21 kg/m2
* "B" class of nutritional status according to Subjective Global Assessment

Exclusion Criteria:

* Hepatitis B, C
* Total circulatory arrest
* Absence of informed consent signed
* Chronic liver diseases
* Gastric resection in patient's history
* Physical limitations of normal feeding

Primary outcomes:
measure: Mortality
timeFrame: 1 month
Secondary outcomes:
measure: Postoperative complications
timeFrame: 1 month
measure: Total lymphocyte count
timeFrame: before operation, 7, 14, 21 postoperative days
measure: Serum albumin
timeFrame: Before operation, 7, 14, 21 postoperaitve days
measure: Serum prealbumin
timeFrame: Before operation, 7, 14, 21 postoperaitve days
measure: Retinol-binding protein
timeFrame: Before operation, 7, 14, 21 postoperaitve days
Other outcomes:
Locations:
city: Novosibirsk
country: Russian Federation
facility: State Research Institute of CIrculation Pathology Novosibirsk, Russian Federation
city: Novosibirsk
country: Russian Federation
facility: State Research Institute of CIrculation Pathology
Study officials:
References:
Clinical trial NCT03108170: Digital Perineal Massage and Pelvic Floor Muscle Exercise During Pregnancy for Prevention of Perineal Laceration
Official title: Digital Perineal Massage and Pelvic Floor Muscle Exercise as an Antenatal Program for Prevention of Perineal Trauma in Elderly Women, a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Delivery; Injury, Maternal
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-04-11
Enrollment: 90
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Pregnant participants will be recruited at the obstetrics outpatient clinic during their visits 4 weeks before the due date. They are randomized into two groups. The first group will be educated to do digital perineal massage. They will be also educated to do pelvic floor muscle exercises and will receive the usual education program for strengthening the pelvic floor. The second group will receive the usual education program for strengthening the pelvic floor. Occurrence of perineal laceration will be reported at time of delivery.

Detailed description: Pregnant participants will be recruited at the obstetrics outpatient clinic during their visits 4 weeks before the due date. They are randomized into two groups. The first group will be educated to do digital perineal massage. They will be also educated to do pelvic floor muscle exercises and will receive the usual educational pelvic floor dysfunction prevention program for strengthening the pelvic floor. The second group will receive the usual education program for strengthening the pelvic floor. Occurrence of perineal laceration will be reported at time of delivery.

Eligibility criteria: Inclusion Criteria:

* Pregnant women ≥ 35 years old
* Primigravida or multi gravida

Exclusion Criteria:

* History of chronic constipation
* History of chronic cough
* Current or past urinary or anal incontinence
* History of genital prolapse before pregnancy
* History of neuromuscular disorders or connective tissue disorders
* History of medical disorders
* History of preterm or precipitate labour
* History of premature preterm rupture of membranes.
* Genital infections

Primary outcomes:
measure: Proportion of participants who have perineal tears
timeFrame: At 15 minutes from delivery
Secondary outcomes:
measure: Proportion of participants who need episiotomy at time of delivery
timeFrame: At 15 minutes from delivery
measure: Duration of the second stage of labour
timeFrame: At 15 minutes from delivery
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Department of Obstetrics and Gynecology, Kasr Al-Ainy hospital
state: Greater Cairo
Study officials:
affiliation: Cairo University
name: Eman Omran, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04321070: Bio-equivalence Study With Clinical Endpoints in the Treatment of Acne Vulgaris
Official title: A Randomized, Double-Blind, Multiple Center Placebo Controlled Study Comparing Taro Product to RLD and Both Treatments to a Placebo Control in the Treatment of Acne Vulgaris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Acne Vulgaris
Lead sponsor: Taro Pharmaceuticals USA
Sponsor class: INDUSTRY
First posted: 2020-03-25
Enrollment: 550
Sex: ALL
Minimum age (years): 12
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Bio-equivalence Study With Clinical Endpoints in the Treatment of Acne Vulgaris

Detailed description: Randomized, Double-Blind, Multiple Center Placebo Controlled Study Comparing Taro Product to RLD and Both Treatments to a Placebo Control in the Treatment of Acne Vulgaris

Eligibility criteria: Inclusion Criteria:

* Healthy male or non pregnant female aged ≥ 12 and ≤ 40years with a clinical diagnosis of acne vulgaris.
* Subjects who are 18 years of age or older (up to the age of 40) must have provided IRB approved written informed consent.
* Subjects must have a definite clinical diagnosis of acne vulgaris severity grade 2, 3, or 4 as per the Investigator's Global Assessment (IGA).

Exclusion Criteria:

* Female Subjects who are pregnant, nursing or planning to become pregnant during study participation
* Subjects with a history of hypersensitivity or allergy to adapalene, retinoids and/or any of the study medication ingredients, have a known hypersensitivity to adapalene and benzoyl peroxide and its excitements.

Primary outcomes:
measure: Demonstration of Bioequivalence
timeFrame: Week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Catawba Research LLC
state: North Carolina
Study officials:
affiliation: Taro Pharmaceuticals, Inc.
name: Natalie Yantovskiy
role: STUDY_DIRECTOR
References: