louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01028768: Pharmacokinetics of 10 mg Teduglutide in Subjects With Renal Impairment Compared to Healthy Subjects With Normal Renal Function
Official title: Open Label Pharmacokinetic (PK) Study, Conducted at One Investigational Site in Germany, to Evaluate the Effect of Renal Impairment on the Pharmacokinetics of Teduglutide Following Subcutaneous Administration of 10 mg Teduglutide and to Evaluate Safety and Tolerability of 10 mg Teduglutide
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Renal Impairment
Keywords: Renal impairment
Renal impairment study
Lead sponsor: Nycomed
Sponsor class: INDUSTRY
Collaborators: name: NPS Pharma
First posted: 2009-12-09
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: To evaluate the effect of renal impairment on the pharmacokinetics (PK) of teduglutide following subcutaneous (SC) administration of 10 mg teduglutide.

Secondary objectives are to assess the safety and tolerability of 10 mg teduglutide. A further objective is the description of the PK of teduglutide following SC administration of 10 mg teduglutide in elderly (≥ 65 years) healthy subjects compared to non elderly healthy subjects.

Detailed description: Pharmacokinetic study.

Eligibility criteria: Inclusion Criteria:

* Subjects with moderate, severe and end stage renal failure and matched healthy controls.

Primary outcomes:
measure: Pharmacokinetics of teduglutide
timeFrame: 24 hrs
Secondary outcomes:
measure: Safety and tolerability of 10 mg teduglutide (assessed by physical examination, vital signs, clinical laboratory, electrocardiogram [ECG] and adverse events [AE])
timeFrame: 7 days
Other outcomes:
Locations:
city: Konstanz
country: Germany
facility: Nycomed GmbH
Study officials:
References:
Clinical trial NCT00556972: A Feasibility Study of a Fecal Incontinence Management System for Medical Use
Official title: A Feasibility Study of a Fecal Incontinence Management System for Medical Use
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Fecal Incontinence
Lead sponsor: Coloplast A/S
Sponsor class: INDUSTRY
First posted: 2007-11-12
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this feasibility study is to evaluate the performance and skin-friendliness of the barrier of the Fecal Incontinence Management System. The investigator will complete a questionnaire for each of the tested products and the products will be evaluated as regards leakage, wear time, and skin-friendliness.

Detailed description: The purpose of this feasibility study is to evaluate the performance and skin-friendliness of the barrier of the Fecal Incontinence Management System. The investigator will complete a questionnaire for each of the tested products and the products will be evaluated as regards leakage, wear time, and skin-friendliness

Eligibility criteria: Inclusion Criteria:

* The subject is at least 18 years of age
* The subject has fecal incontinence

Exclusion Criteria:

* The subject is pregnant and/or breastfeeding
* The subject has perianal fistulas and/or hemorrhoids
* It's estimated that the subject's perianal skin makes it inappropriate for subject to participate in the study (i.e. in case of damaged skin, very sweaty skin or very sinuous and folded skin)

Primary outcomes:
measure: The Primary Outcome Measure is Device Wear Time (Time From the Device is Applied Until it is Removed)
timeFrame: 5 days
Secondary outcomes:
measure: Is the Barrier Size and Shape Satisfactory
timeFrame: Subjects were followed for the duration of the study, an average of 23 hours
measure: Assessment of Skin 0-2 Inches From the Edge of the Anus
timeFrame: Subjects were evaluated before and after test
measure: What is Your Assessment of the Ease of Correct Application of the Anal Adhesive?
timeFrame: After application of product
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center, Inc.
state: Massachusetts
Study officials:
affiliation: Coloplast A/S
name: Thais Benjamin N. Christensen, M.Sc. (BME)
role: STUDY_CHAIR
References:
Clinical trial NCT03507972: Evaluation of the Benefits of Ultrasound in Improving the Diagnosis and Management of Injuries the Child's Ankle
Official title: Evaluation of the Benefits of Ultrasound in Improving the Diagnosis and Management of the Child's Traumatic Ankle Injuries
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ankle Trauma
Keywords: ankle
diagnostic
ankle's ultrasound
traumatic lesion
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2018-04-25
Enrollment: 350
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Evaluate ankle's ultrasound contribution in the accuracy of ankle's diagnosis of traumatic injuries (objectivated by reference's examination : ankle's MRI)


Eligibility criteria: Inclusion Criteria:

* Age ≥ 5 years and \< 18 years
* Isolated's trauma from one or both ankles
* First-line consultation for pediatrics emergencies at the University Hospital of Lille
* Informed and written consent of the holders of parental authority

Exclusion Criteria:

* Age \< 5 years and ≥ 18 years
* History of trauma of the same ankle dating from less than 3 month
* History of surgery of this same ankle
* Constitutional or acquired bone disease
* Associated trauma affecting another anatomical region than the ankle or midfoot
* Polytrauma (presence of several traumas including at least one endangers vital functions)
* Associated wound requiring surgical exploration
* initial management of this trauma in another center
* Non affiliation to a social security scheme

Primary outcomes:
measure: Diagnostic performance rate of anatomical lesions of the ankle of ultrasound
timeFrame: Baseline (inclusion)
Secondary outcomes:
measure: Diagnostic performance rate of anatomical lesions
timeFrame: Baseline (inclusion) and at visit 2 (within 7 days after the baseline)
measure: The use of Ottawa decision rule
timeFrame: baseline (inclusion)
measure: orthopedic rehabilitation quality at 3 weeks according to the Oxford score.
timeFrame: at 3 weeks (control visit)
Other outcomes:
Locations:
city: Lille
country: France
facility: Unité de pédiatrie Générale, Urgences et Maladies Infectieuses, Pôle de l'Urgence, Hôpital Roger Salengro
Study officials:
affiliation: University Hospital, Lille
name: François Dubos, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03267472: Pattern of Genitourinary Fistula in Upper Egypt
Official title: the Genitourinary Fistula Experience in Upper Egypt
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Data Collection
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-08-30
Enrollment: 35
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A genitourinary fistula is defined as an abnormal communication between the urinary (ureters, bladder, urethra) and the genital (uterus, cervix, vagina) systems.

The true incidence of genitourinary fistula is unknown. Uro-genital fistulas are a great challenge for women in developing countries. The new classification of genitourinary fistula divides genitourinary fistulae into four main types, depending on the distance of the distal edge of the fistula from the external urinary meatus.

Brief summary: the pattern of genitourinary fistula in upper egypt

Detailed description: A genitourinary fistula is defined as an abnormal communication between the urinary (ureters, bladder, urethra) and the genital (uterus, cervix, vagina) systems.

The true incidence of genitourinary fistula is unknown. Uro-genital fistulas are a great challenge for women in developing countries.

The new classification of genitourinary fistula divides genitourinary fistulae into four main types, depending on the distance of the distal edge of the fistula from the external urinary meatus. These four types are further subclassified by the size of the fistula, extent of associated scarring, vaginal length or special considerations:

Type 1: Distal edge of fistula \> 3.5 cm from external urinary meatus Type 2: Distal edge of fistula 2.5-3.5 cm from external urinary meatus Type 3: Distal edge of fistula 1.5 - \< 2.5 cm from external urinary meatus

Eligibility criteria: Inclusion Criteria:

- any female with genitourinary fistula

Exclusion Criteria:

* no

Primary outcomes:
measure: prevalence of genitourinary fistula in upper egypt
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04948372: Effects of Terlipressin on Renal Perfusion in Patients With Septic Shock
Official title: Effects of Terlipressin Added to Usual Care vs. Usual Care Alone on Renal Perfusion in Patients With Septic Shock
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Septic Shock
Keywords: septic shock
terlipressin
renal perfusion
acute kidney injury
Lead sponsor: Southeast University, China
Sponsor class: OTHER
First posted: 2021-07-01
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This open-label, randomized controlled trial aimed to investigate the effect of a fixed dose of terlipressin added to usual care vs. usual care alone on renal perfusion in patients with septic shock.

Detailed description: Terlipressin is a synthetic vasopressin analog with great affinity to the V1 receptor (vasoconstrictive effect), and could selectively contract efferent arterioles, increase glomerular filtration pressure and renal perfusion. The investigators conducted this open-label, randomized controlled trial to observe the effects of a fixed dose of terlipressin added to usual care vs. usual care alone on renal perfusion in patients with septic shock. Renal perfusion was monitored by renal contrast-enhanced ultrasound. The primary outcome was peak intensity (renal perfusion parameter) at 24 hours after enrollment.

Eligibility criteria: Inclusion Criteria:

1. Adult septic shock patients (age≥18 years old)
2. Norepinephrine dose was more than or equal to 15μg/min

Exclusion Criteria:

1. Age older than 85 years
2. Serum creatinine more than 177 μmol/L
3. Acute myocardial ischemia
4. Acute mesenteric artery ischemia
5. Pregnancy
6. Expected death within 24 hours.

Primary outcomes:
measure: Peak intensity
timeFrame: 24 hours after enrollment
Secondary outcomes:
measure: urine output, mL
timeFrame: 24 hours after enrollment
measure: The incidence of acute kidney injury
timeFrame: Within 28 days
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing Zhongda Hospital, Southeast University
state: Jiangsu
Study officials:
References:
Clinical trial NCT00667472: Combined Pulsed Dye Laser and Topical Ranibizumab for Treatment of Port Wine Stain Birthmarks
Official title: Combined Pulsed Dye Laser and Topical Ranibizumab for Treatment of Port Wine Stain Birthmarks
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Port-Wine Stain
Keywords: port wine stain birthmarks
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: Beckman Laser Institute University of California Irvine
First posted: 2008-04-28
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to improve port wine stain therapeutic outcome in response to laser therapy. The researcher want to determine whether the combined use of pulsed dye laser therapy and topical ranibizumab will improve port wine stain therapeutic outcome.

Detailed description: Combined use of pulsed dye laser to induce port wine stain blood vessel injury, and ranibizumab to prevent port wine stain blood vessel angiogenesis and recanalization after laser therapy, will improve port wine stain lesion blanching.

After pulsed dye laser treatment of the entire port wine stain, topical ranibizumab will be applied to two of the test sites for two weeks following pulsed dye laser therapy. The degree of port wine stain blanching which will be quantified objectively using visible reflectance spectroscopy measurements. port wine stain test site blanching responses following the combined use of pulsed dye laser and topical ranibizumab will be compared with pulsed dye laser only and with the baseline controls.

Eligibility criteria: Inclusion Criteria:

* Port Wine Stain suitable for comparison testing
* Age \> 18 years of age

Exclusion Criteria:

* History of photodermatoses or skin cancer
* use of known photosensitizing drugs
* use of immunosuppressive drugs or systemic steroids
* Pregnancy

Primary outcomes:
measure: Port Wine Stain response to laser treatment
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Beckman Laser Institute University of California Irvine
name: John s Nelson, M.D,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01629472: Protection From Gender-based Violence in Cote d'Ivoire
Official title: Protection From Gender-based Violence in Cote d'Ivoire
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Domestic Violence
Family and Household
Keywords: Gender norms
Financial Autonomy
Economic Well-being
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Innovations for Poverty Action
name: International Rescue Committee
First posted: 2012-06-27
Enrollment: 981
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: There is some evidence that suggests that economic empowerment and challenging gender inequalities and prevailing ideas on masculinities will lead to a decrease in levels of partner violence. However, there is still a gap in our understanding of what elements are required. This project evaluates whether participation within a savings group and a discussion group confronting gender norms will lead to an increase in women's individual agency and decision-making ability that will improve their economic independence and decrease intimate partner violence in their homes.


Eligibility criteria: Inclusion Criteria:

* No Prior experiences with microcredit programs
* 18+
* Source of stable income

Exclusion Criteria:

* 18+
* prior experience with microcredit

Primary outcomes:
measure: To assess differences in past year, self-reported intimate partner violence (physical and sexual)between treatment and control groups. This will be assessed using the CTS-2 scale
timeFrame: 24 months post baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Abidjan
country: Côte D'Ivoire
facility: International Rescue Committee
Study officials:
affiliation: Yale University
name: jhumka gupta, ScD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gupta J, Falb K, Kpebo D, Annan J. Abuse from in-laws and associations with attempts to control reproductive decisions among rural women in Cote d'Ivoire: a cross-sectional study. BJOG. 2012 Aug;119(9):1058-66. doi: 10.1111/j.1471-0528.2012.03401.x. Epub 2012 Jun 7.
citation: Blay-Tofey M, Lee BX. Preventing gender-based violence engendered by conflict: The case of Cote d'Ivoire. Soc Sci Med. 2015 Dec;146:341-7. doi: 10.1016/j.socscimed.2015.10.009. Epub 2015 Oct 14.
citation: Gupta J, Falb KL, Lehmann H, Kpebo D, Xuan Z, Hossain M, Zimmerman C, Watts C, Annan J. Gender norms and economic empowerment intervention to reduce intimate partner violence against women in rural Cote d'Ivoire: a randomized controlled pilot study. BMC Int Health Hum Rights. 2013 Nov 1;13:46. doi: 10.1186/1472-698X-13-46.
Clinical trial NCT04749472: Biomechanical Analysis of Scapula and Humerus With Different Shoulder Slings
Official title: Biomechanical Analysis of Scapula and Humerus With Different Shoulder Slings
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Shoulder Injuries
Surgery
Keywords: Rehabilitation
Shoulder Surgery
Postoperative
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2021-02-11
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Participants wore different sling in a randomized order.
Primary purpose: BASIC_SCIENCE

Brief summary: Participants will be measured with motion monitor system while using 6 different slings. Measurement order will be randomized, and 5 minutes resting period will be given prior measurement. Scapula, humerus and thorax positions will be recorded in resting position and then with slings.


Eligibility criteria: Inclusion Criteria:

-

Exclusion Criteria:

* Having a shoulder surgery
* Having scapular dyskinesis,
* Having shoulder pain,
* Having any disease that could affect posture and/or shoulder (such as scoliosis)

Primary outcomes:
measure: Motion Monitor
timeFrame: During rest position without and with different slings for 5 seconds.
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
References:
Clinical trial NCT02205372: Safety, Tolerability and Pharmacokinetic Study of MT-3995 at a Low Dose in Subjects With Diabetic Nephropathy
Official title: A Phase II, Randomised, Double-blind, Placebo-controlled Study of MT-3995 (Low Dose) in Subjects With Diabetic Nephropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Diabetic Nephropathy
Keywords: Diabetic Nephropathy
Lead sponsor: Mitsubishi Tanabe Pharma Corporation
Sponsor class: INDUSTRY
First posted: 2014-07-31
Enrollment: 31
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
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 evaluate safety, tolerability and pharmacokinetics of MT-3995 in Subjects with Diabetic Nephropathy.


Eligibility criteria: Inclusion Criteria:

* Subjects with Type 2 diabetes mellitus and diabetic nephropathy, who have been treated with a stable dose of angiotensin converting enzyme-inhibitor (ACE-I) or angiotensin II receptor blocker (ARB)
* Glycosylated haemoglobin (HbA1c) ≤10.5%
* Subject with albuminuria

Exclusion Criteria:

* Subjects with type 1 diabetes mellitus, diabetes mellitus resulting from pancreatic disorder, secondary diabetes mellitus (Cushing's syndrome, steroidogenic diabetes).
* Serum potassium level \<3.5 or \>5.0 mmol/L
* Subjects who had acute kidney injury within 3 months prior to baseline or have undergone hemodialysis at any time prior to randomisation
* Subjects with clinically significant hypotension

Primary outcomes:
measure: Frequency and nature of treatment-emergent adverse events and serious adverse events.
timeFrame: 20 weeks
Secondary outcomes:
measure: Plasma concentrations of MT-3995
timeFrame: 20 weeks
measure: Plasma concentrations of major metabolite of MT-3995
timeFrame: 20 weeks
measure: Change from baseline in Urine albumin-to-creatinine ratio (UACR)
timeFrame: 20 weeks
measure: Change from baseline in blood pressure
timeFrame: 20 weeks
Other outcomes:
Locations:
city: Sapporo
country: Japan
facility: Touei Hospital
state: Hokkaido
Study officials:
affiliation: Division of Nephrology and Endocrinology University of Tokyo School of medicine
name: Masaomi Nangaku, Professor
role: STUDY_DIRECTOR
affiliation: Mitsubishi Tanabe Pharma Corporation
name: Kazuoki Kondou, Adviｓer
role: STUDY_DIRECTOR
References:
Clinical trial NCT03000972: PFN-A Augmentation for Intertrochanteric Femoral Fractures
Official title: PFN-A Intramedullary Nail and Intertrochanteric Hip Fracture. Augmentation of the Femoral Head Assessed by PET-CT (Positron Emission Tomography - Computed Tomography)- a Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intertrochanteric Fracture
Keywords: Augmentation
PET-CT
Positron Emission Tomography
Fluorine-18
Lead sponsor: Uppsala University
Sponsor class: OTHER
First posted: 2016-12-22
Enrollment: 20
Sex: ALL
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the potential negative effect of cement augmentation in the femoral head on viability of the head. Half of the participants will have the standard intramedullary nail (PFN-A; Proximal Femoral Nail Augmentation), while the other half will get the standard nail plus cement augmentation.

Detailed description: Cement augmentation is believed to increase the bone implant interface and therefore decrease the risk of implant cut-out of the femoral head. The cement used in previous studies has produced heat and thermal necrosis on bone cells. The cement used in this study (TraumaCemV+) is manufactured specially for this implant and for the augmentation of this implant. TraumaCemV sets under low temperature (40 degrees Celsius) and we do not anticipate any heat necrosis. The volume effect of the cement could theoretically also damage the blood flow in the femoral head. There have been no negative effects in big series of patients operated with this technique.

The aim of this study is to quantify the viability of the femoral head with the use PET-CT (Positron Emission Tomography with simultaneous Computed Tomography) including a radioactive isotope (Fluorine-18) and the use of threedimensional computed tomography.

Eligibility criteria: Inclusion Criteria:

* Intertrochanteric Hip Fracture AO (Arbeitsgemeinschaft für Osteosynthesefragen) 31-A1 or AO 31-A2
* Healthy contralateral hip
* ASA (American Society of Anesthesiologists) Physical Status Class I or II

Exclusion Criteria:

* Dementia

Primary outcomes:
measure: Viability of the femoral head as assessed by fluoride uptake using PET-CT
timeFrame: 4 months postoperatively
Secondary outcomes:
measure: Viability of the femoral head as assessed by fluoride uptake using PET-CT
timeFrame: Within 1 week postoperatively
measure: Viability of the femoral head as assessed by fluoride uptake using PET-CT
timeFrame: 1 year postoperatively
measure: Harris Hip Score
timeFrame: 4 months
measure: Harris Hip Score
timeFrame: 1 year
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Uppsala University Hospital
state: Uppsala Lan
Study officials:
affiliation: Uppsala University Hospital
name: Olof Wolf, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: