louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00811863: Evaluation of Nephrogenic Systemic Fibrosis (NSF) in Patients With Chronic Kidney Disease Following OptiMARK Injection
Official title: A Prospective Study for the Detection of Nephrogenic Systemic Fibrosis in Patients With Renal Impairment Undergoing Gadoversetamide-enhanced Magnetic Resonance Imaging
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Nephrogenic Systemic Fibrosis
Renal Insufficiency
Keywords: Nephrogenic Systemic Fibrosis
Renal Insufficiency
Gadoversetamide
OptiMARK
Magnetic Resonance Imaging
Lead sponsor: Guerbet
Sponsor class: INDUSTRY
First posted: 2008-12-19
Enrollment: 0
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: Subjects with moderate to severe renal insufficiency that have been identified as requiring (for any indication) a contrast-enhanced MRI using gadoversetamide.

Brief summary: The objective of this study is to prospectively monitor the incidence of adverse drug reactions, specifically NSF during routine use of gadoversetamide in a large number of patients with moderate renal insufficiency (eGFR 30-59) and severe renal insufficiency or end-stage renal disease requiring dialysis (eGFR \<30).


Eligibility criteria: Inclusion Criteria:

* Referred for contrast-enhanced MRI using gadoversetamide;
* Have a documented estimated glomerular filtration rate (eGFR) of \<60 mL/min/1.73 m2 within the past 6 months or ESRD requiring dialysis; and
* Willing and able to provide written consent (themselves or by a legally authorized representative) and agree to abide by study requirements, including being seen by a dermatologist and undergoing a skin biopsy if NSF is suspected.

Exclusion Criteria:

* Have experienced a previous hypersensitivity reaction to a GBCA;
* Have pre-existing NSF or NSF-like symptoms; or
* Have been exposed to a GBCA within 12 months prior to the index procedure; or
* Has a medical condition or other personal situation that would prevent providing follow-up information, completing clinic visits or otherwise supplying meaningful data to meet study objectives.

Primary outcomes:
measure: The primary outcome measure will be the diagnosis of NSF based on clinical assessments and patient telephone calls through 24 months of follow-up.
timeFrame: 1, 3, 6, 12, 18 and 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Youngstown
country: United States
facility: Radiology Consultants, Inc.
state: Ohio
Study officials:
affiliation: Mallinckrodt
name: Herbert R. Neuman, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05784363: A Study of NT 201 in the Treatment of Enlarged Pores and Excessive Sebum Production in the Face
Official title: A Prospective, Randomized, Double-blind, Placebo-controlled, Multi-center Exploratory Study to Investigate NT 201 in the Treatment of Enlarged Pores and Excessive Sebum Production in the Face
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Enlarged Pores
Sebum Production
Lead sponsor: Merz North America, Inc.
Sponsor class: INDUSTRY
First posted: 2023-03-24
Enrollment: 31
Sex: ALL
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the efficacy and safety of NT 201 injections in the treatment of enlarged pores and excessive sebum production in the face.

Detailed description: Eligible subjects will be randomized to one of the two treatment groups: NT 201 group and placebo in order to receive one session of injections with either NT 201 or placebo in the upper face (forehead and cheek area) on Day 1 and followed for about 90 days after treatment.

Eligibility criteria: Inclusion Criteria:

* Cheek pore size assessed as "large" by the investigator
* Oily skin on the forehead

Exclusion Criteria:

* Treatment with Botulinum toxin (BoNT) of any serotype in the face within the last 12 months
* Facial cosmetic procedure (e.g., chemical peel, photo rejuvenation, mesotherapy, photodynamic therapy, laser treatment, ultrasound treatment, tattooing of eyebrows) within the last 12 months
* Treatment with any dermal filler in the face within the last 12 months
* Any previous insertion of permanent material in the face, including permanent dermal fillers (e.g., silicone, polymethyl methacrylate)
* Any medical condition that may put the subject at increased risk with exposure to botulinum toxin of any serotype

Primary outcomes:
measure: Change from Baseline to Week 4 in Pore Volume in the Cheek Area
timeFrame: Baseline (Day 1), Week 4
measure: Change from Baseline to Week 4 in Sebum Level in the Forehead Area
timeFrame: Baseline (Day 1), Week 4
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Merz Investigation Site #0010473
state: California
city: Coral Gables
country: United States
facility: Merz Investigation Site #0010101
state: Florida
city: Nashville
country: United States
facility: Merz Investigation Site #001097
state: Tennessee
Study officials:
affiliation: Merz North America, Inc.
name: Merz Medical Expert
role: STUDY_DIRECTOR
References:
Clinical trial NCT06745063: Arterial Destiffening Effects of SGLT2 Inhibition in Veterans With Obesity
Official title: Arterial Destiffening Effects of SGLT2 Inhibition in Veterans With Obesity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Obesity
Vascular Health
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: University of Missouri-Columbia
First posted: 2024-12-20
Enrollment: 50
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: placebo-controlled trial
Primary purpose: TREATMENT

Brief summary: The study will assign participants to take either the medication, empagliflozin or a placebo for 12 weeks. The goal of the study is to determine the effects of empagliflozin on arterial health in Veterans with obesity.

Detailed description: The investigators will employ a double-blinded randomized placebo-controlled trial to determine the effects of 12 weeks of SGLT2 inhibition with empagliflozin (10mg daily), or matching placebo, on arterial stiffness in Veterans with obesity. Fifty Veterans with obesity (BMI 30-45kg/m2), 30-60 years of age, will be recruited from the Harry S. Truman Memorial VA Hospital in Columbia, Missouri.

Eligibility criteria: Inclusion Criteria:

* Body mass index (BMI) 30-45 kg/m2
* 30-60 years of age at randomization
* Evidence of arterial stiffening (defined as Carotid femoral PWV\>age-predicted) at screening visit (PMID: 20530030)

Exclusion Criteria:

* Unable to provide consent
* Diabetes mellitus
* Uncontrolled hypertension (\>180/90mmHg) or systolic \<100mmHg at screening visit
* Known history of cardiovascular disease: heart failure, ischemic heart disease, peripheral artery disease or stroke
* Diagnosis of chronic kidney disease
* Active cancer (excluding basal cell carcinoma or stage 1 squamous cell carcinoma of the skin)
* Excessive alcohol consumption (\>14 drinks/week for men, \>7 drinks/week for women)
* Use of GLP-1 analogs or SGLT2 inhibitors
* Use of hormone replacement therapy
* Use of pharmacological therapy for weight loss
* Body weight changes \>10% within the past 6 months
* History of hypersensitivity to nitrates
* History of ketoacidosis
* History of recurrent UTIs or mycotic genital infections
* Use of anticoagulants
* Change in anti-hypertensive medication regimen (if in use) during the last 90 days
* Pregnancy

Primary outcomes:
measure: Carotid-femoral Pulse Wave Velocity (cfPWV)
timeFrame: baseline (t0), week 4, week 8, week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Columbia
country: United States
facility: Harry S. Truman Memorial, Columbia, MO
state: Missouri
Study officials:
affiliation: Harry S. Truman Memorial, Columbia, MO
name: Jaume Padilla Parellada, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02292563: The Impact of Experienced Endoscopy Nurse Participation on Polyp and Adenoma Detection During Colonoscopy
Official title: Can Experienced Endoscopy Nurse Participation During Screening Colonoscopy Increase Polyp and Adenoma Detection Rate?:A Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polyp
Adenoma
Keywords: Nurse; Colonoscopy; Polyp; Adenoma;
Lead sponsor: Ningbo No. 1 Hospital
Sponsor class: OTHER
First posted: 2014-11-17
Enrollment: 660
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether experienced endoscopy nurse participation during screening colonoscopy could increase polyp and adenoma detection rate.


Eligibility criteria: Inclusion Criteria:

* age 40-70 average risk screening colonoscopy

Exclusion Criteria:

* GI Bleeding ;
* history of colorectal surgery ;
* inflammatory bowel disease ;
* colorectal cancer,or polyposis syndrome

Primary outcomes:
measure: Polyp detection rate
timeFrame: 1.5 year
measure: adenoma detection rate
timeFrame: 1.5 year
Secondary outcomes:
measure: Advanced polyp detection rate
timeFrame: 1.5 year
Other outcomes:
Locations:
city: Ningbo
country: China
facility: Ningbo NO.1 hospital
state: Zhejiang
Study officials:
affiliation: Ningbo No. 1 Hospital
name: XIAOYUN DING, M.D
role: STUDY_DIRECTOR
References:
citation: Wang W, Xu L, Bao Z, Sun L, Hu C, Zhou F, Xu L, Shi D. Differences with experienced nurse assistance during colonoscopy in detecting polyp and adenoma: a randomized clinical trial. Int J Colorectal Dis. 2018 May;33(5):561-566. doi: 10.1007/s00384-018-3003-0. Epub 2018 Mar 14.
Clinical trial NCT03943563: Compare Diagnostic Performance of DIXON &CHESS Sequences Calculating RAMRIS Score in Early Rheumatoid Arthritis.
Official title: Comparison of Diagnostic Performance of DIXON Sequences With CHESS Sequences by Calculation of the RAMRIS Score in Early Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthritis, Rheumatoid
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2019-05-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: In a preliminary MRI study of healthy volunteers's hands investigators showed that the suppression of the fat signal obtained by the Dixon sequences is greater than that obtained by the "classic" CHESS sequences with a better T1-weighted image quality. The investigators goal now is to compare these sequences in the quantification of the inflammatory activity of rheumatoid arthritis by the RAMRIS score. To investigators knowledge, only one study compared those two types of sequence with many limitations including a limited number of patients included.

Detailed description: Rheumatoid arthritis (RA) is the most common chronic inflammatory arthropathy and it mostly affect young women. The MRI sequences currently validated for the joint inflammation assessment are the fat-suppressed sequences produced either by spectral presaturation (CHESS sequences) or by inversion-recovery (STIR = short tau inversion recovery sequence). The presaturation sequences outweigh the STIR sequence due to higher spatial resolution at the expense of sometimes more random saturation of the fat signal. Recently, a third method of suppressing the fat signal (Dixon method) has reappeared thanks to advances in computing power (post-processing). In a preliminary MRI study of the hands of healthy volunteers, the investigators showed that the suppression of the fat signal obtained by the Dixon sequences is greater than that obtained by the "classic" CHESS sequences in T1 and T2 weighting with better quality. image in T1 weighting. This increased performance, particularly in terms of fat suppression, could lead to better detection of PR lesions on MRI.

Eligibility criteria: Inclusion Criteria:

* - Rheumatoid arthritis diagnosis for less than 3 years

Exclusion Criteria:

* contraindication to Dotarem contrast injection
* contraindication to MRI due to incompatible implanted material (peacemaker, prosthesis,...)

Primary outcomes:
measure: Ramris score
timeFrame: an average of 3 year
Secondary outcomes:
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires Saint Luc
Study officials:
References:
Clinical trial NCT03111563: Effectiveness of Warm Saline Distension Media on Relieving Pain in Office Hysteroscopy
Official title: Effectiveness of Warm Saline Distension Media on Relieving Pain in Office Hysteroscopy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hysteroscopy
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2017-04-13
Enrollment: 82
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of the study is to compare the effectiveness of warm saline distension media versus room temperature saline distension media on relieving pain in office hysteroscopy .

Detailed description: Research hypothesis :

In women undergoing diagnostic hysteroscopy, warm saline distension media may be effective in decreasing the pain during the procedure .

Research question :

In women undergoing diagnostic hysteroscopy, does warm saline distension media decrease the pain during the procedure ?

Aim of the work :

- This study aim to assess the efficacy of warm saline distension media in decreasing the pain in women undergoing diagnostic hysteroscopy

Eligibility criteria: Inclusion Criteria:

1. Age: 20-40 years old (premenopausal women ).
2. Normal cervical morphology during speculum examination.
3. Women complaining of abnormal uterine bleeding
4. Women underging the procedure to evaluate the endocervical canal, uterine cavity and tubal ostia because of infertility.
5. Suspected mullerian anomalies.

Exclusion Criteria:

* a. Pregnancy. b. Suspected acute pelvic inflammatory disease. c. Past history of medical disorders, especially associated with neuropathies, e.g. diabetes, chronic kidney disease, etc.

  d. History of vaginal pruritis, discharge, dysuria, dysmenorrhea, dyspareunia or chronic pelvic pain.

  e. Presence of pain, profuse bleeding or other symptoms at the time of the procedure.

  f. History of uterine surgery that occurred less than 1 month previously. g. History of previous cervical procedures. h. Administration of general, cervical or paracervical anesthesia. i. Administration of sedatives. j. Any use of analgesic agents before the procedure. k. Cervical preparation by misoprostol before procedure orally or vaginally for cervical ripening to improve the likelihood of successful cervical dilation and decrease intraoperative pain .

  l. Need for cervical dilatation during procedure. m. Need for biopsy or any operative intervention during the procedure.

Primary outcomes:
measure: assesment of pain immediately at the end of the procedure and 15 minutes after it
timeFrame: immediately after the procedure and 15 minutes after the end of it
Secondary outcomes:
measure: patient satisfaction
timeFrame: during procedure
measure: time taken to complete the procedure
timeFrame: during procedure
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03510663: Phase I Study of OPC-61815
Official title: A Single-center, Randomized, Double-blind (for OPC-61815 and Placebo), Placebo- and Moxifloxacin Positive-controlled, 4-Period Crossover Trial to Evaluate the Effect of Single Intravenous Administration of OPC-61815 at 16 and 32 mg on QT/QTc Interval in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Congestive Heart Failure
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2018-04-27
Enrollment: 48
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To investigate the effects of intravenous administration of OPC-61815 at 16 and 32 mg on QT/QTc interval in healthy male subjects


Eligibility criteria: Inclusion Criteria:

* Body mass index (BMI) \[body weight in kg / (height in m)2\] of at least 18.5 kg/m2 and less than 25.0 kg/m2 as a result of at the screening examination
* Judged by the investigator or subinvestigator to be capable of providing written informed consent prior to start of any trial-related procedures and capable of complying with the procedures for this trial

Exclusion Criteria:

* Subjects with a medical history of convulsive disorder, long QT syndrome (including family history), syncope during swimming, or any other type of syncope or cryptogenic loss of consciousness
* Subjects with a serum electrolyte abnormality (hypokalemia, hypomagnesemia, hypocalcemia, etc)
* Subjects with a family history of sudden death

Primary outcomes:
measure: Time-matched Difference Between the OPC-61815/Moxifloxacin and Placebo Data in Change From Baseline for QTcF in 12-lead Holter Electrocardiogram (ECG)
timeFrame: Baseline, 1h, 1.5h, 2h, 3h, 4h, 6h, 12h, 24h after dosing
Secondary outcomes:
Other outcomes:
Locations:
city: Fukuoka
country: Japan
facility: Kyusyu Region
Study officials:
affiliation: Otsuka Pharmaceutical Co., Ltd.
name: Osamu Sato
role: STUDY_DIRECTOR
References:
Clinical trial NCT05767463: Correlation Between Pelvic Pain, Low Back Pain, and Postural Stability in Healthy Young Women During the Menstrual Cycle
Official title: Correlation Between Pelvic Pain, Low Back Pain, and Postural Stability in Healthy Young Women During the Menstrual Cycle
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pain, Menstrual
Keywords: Pelvic pain, low back pain
Postural stability, and menstrual cycle
Lead sponsor: October 6 University
Sponsor class: OTHER
First posted: 2023-03-14
Enrollment: 85
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 22
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: All young females will be recruited from the physical therapy faculty, October 6 University.

All the assessment measurements will be done at the faculty of physical therapy, on October 6 University

Brief summary: The menstrual cycle is governed by hormonal changes. Each cycle can be divided into three phases based on events in the ovary (ovarian cycle) or in the uterus (uterine cycle).

H0: There will be no correlation between pelvic pain and postural stability in healthy young women during the menstrual cycle H0: There will be no correlation between low back pain and postural stability in healthy young women during the menstrual cycle H0: There will be no correlation between pelvic pain and low back pain in healthy young women during the menstrual cycle

Detailed description: Thirty-five female patients participated in this study. They were randomly assigned to the study. The outcome measures were pelvic pain assessed using the functional pelvic pain scale, low back pain assessed using the back pain functional scale, and postural stability assessed using the Biodex balance system.

Eligibility criteria: Inclusion Criteria:

1. All young females will suffer from pelvic pain, low back pain, and postural instability during the menstrual cycle
2. Age will range from 18 to 22 years
3. All young females will have a BMI range from 25-30

Exclusion Criteria:

1. Lumbar spondylosis
2. Lumbar disc prolapse
3. Sacroiliac joint arthritis
4. Low back trauma
5. BMI more than 30

Primary outcomes:
measure: Functional pelvic pain scale
timeFrame: 30 days
measure: Back pain functional scale
timeFrame: 30 days
measure: Postural stability by using Biodex Balance System
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: October 6 University
Study officials:
References:
Clinical trial NCT00232063: Long-term Study of Ciclosporin for Atopic Dermatitis
Official title: Long-term Study of Ciclosporin for Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Severe Atopic Dermatitis
Keywords: Atopic Dermatitis, Ciclosporin,
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-10-04
Sex: ALL
Minimum age (years): 20
Maximum age (years): 64
Standard ages: ADULT
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In patients with severe adult atopic dermatitis, the safety and efficacy of OL27-400MEPC will be assessed by repeating oral administration at a dose of 3 mg/kg/day (2-5 mg/kg/day) in 2 divided doses daily for 8-12 weeks and recovery until 52 weeks after starting treatment


Eligibility criteria: Inclusion Criteria:

* - Appropriate the definition/diagnosis criteria of atopic dermatitis of the Japanese Dermatological Association
* Patients with severest atopic dermatitis \[according to the "Guidelines for Treatment of Atopic Dermatitis 2002, the severity of atopic dermatitis will be classified as severest when an eruption associated with severe inflammation (a lesion associated with erythema, papule, erosion, infiltration, lichenification, etc.) is noted on at least 30% of body surface on the day of subject enrollment\].

Exclusion Criteria:

* Patients who received oral preparations, injections, inhaled preparations and suppositories of steroids or immunosuppressants other than tacrolimus hydrate ointments within 14 days of subject enrollment
* Patients who might receive the oral/injection drugs which are known to enhance nephrotoxicity, increase serum potassium levels, HMG-CoA reductase inhibitors or theophylline during the treatment period.
* Patients who received or are receiving an ultraviolet therapy (PUVA therapy, etc.)
* Patients with hypertension, active infectional disease, gout etc. Other protocol-defined exclusion criteria may apply.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Novartis Pharmaceuticals Japan
name: Novartis Pharmaceuticals Japan
role: STUDY_CHAIR
References: