louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01197235: Effect of Darbepoetin in Contrast-induced Nephropathy
Official title: Prevention of Contrast-Induced Nephropathy by Darbepoetin in Patients With Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Acute Kidney Injury
Keywords: darbepoetin, chronic kidney disease, coronary angiography
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
Collaborators: name: SMG-SNU Boramae Medical Center
First posted: 2010-09-09
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether the drug that produce red blood cells is effective in the prevention of kidney dysfunction after coronary angiography in patients with chronic kidney disease.

Detailed description: Use of radiocontrast agent is inevitable in computed tomography or angiography. However, contrast agent can aggravate kidney function. Contrast-induced nephropathy (CIN) refers to the clinical situation where decreased kidney function after use of contrast. CIN is the 3rd most common cause of acute kidney injury in the hospitals. There are a lot of reports that death rate is increased in patients with CIN.

Erythropoietin is an agent that treat anemia. It also has been reported to have a tissue-protective effect in the animal experiments.

In this study, we hypothesized that erythropoietin can reduce the incidence of CIN in patients with chronic kidney disease undergoing coronary angiography.

Eligibility criteria: Inclusion Criteria:

* age over 18 yr
* estimated glomerular filtration rate (GFR) \< 60 ml/min/1.73m2

Exclusion Criteria:

* Chronic renal replacement therapy (hemodialysis, peritoneal dialysis, continuous renal replacement therapy)
* Pregnancy or lactation
* Use of contrast agent within 1 week
* Emergent CAG or PCI
* Not recovered from AKI(acute kidney injury)
* Use of nephrotoxic drugs within 48 hr
* Cardiogenic shock (SBP(systolic blood pressure) \< 90 mmHg) or pulmonary edema
* Uncontrolled hypertension (SBP ≥ 200 mmHg or DBP(diastolic blood pressure) ≥ 130 mmHg)
* History of hypersensitivity to contrast agent
* Known allergy or hypersensitivity to EPO(erythropoietin)
* Use of EPO within 1 month
* Anemia (hemoglobin \< 9 g/dL)
* Ventilatory care

Primary outcomes:
measure: incidence of contrast-induced nephropathy (CIN)
timeFrame: 48 hours
Secondary outcomes:
measure: maximum difference in Cr levels before and after CAG(coronary angiography) or PCI(percutaneous coronary intervention)
timeFrame: 1 month after the intervention
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital,
Study officials:
affiliation: Seoul Ntional University Bundang Hospital, Seoul National University College of Medicine
name: Ki Young Na, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06520735: Effect of Transcutaneous Electrical Nerve Stimulation Versus Capsicum Plaster on Emesis Gravidarum
Official title: Effect of Transcutaneous Electrical Nerve Stimulation Versus Capsicum Plaster on Emesis Gravidarum
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Emesis Pregnancy
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-07-25
Enrollment: 50
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will be conducted to determine the difference between the effect of transcutaneous electrical nerve stimulation and capsicum plaster on emesis gravidarum.

Detailed description: Almost 50-90% of pregnant women experience nausea vomiting in the first trimester. Nausea vomiting occurs in 60% -80% primigravida and 40% -60% in multigravida.It is revealed that 50% of affected women have a significant reduction of their work efficiency.

Transcutaneous acupoint electrical stimulation (TAES) at the Nei-Guan P6 acupoint may be a useful alternative to antiemetic drugs. It is effective in the treatment of both motion sickness and pregnancy induced nausea and vomiting , as well as emesis associated with chemotherapy.

Capsicum plaster is an alternative to acupuncture. It is applied to the acupuncture points and has been reported to be an effective method for preventing postoperative nausea and vomiting (PONV), postoperative sore throat, and postoperative pain.

Eligibility criteria: Inclusion Criteria:

* Pregnant women complaining of emesis gravidarum
* Their ages will be ranged from 20 to 35 years old.
* Their body mass index will not exceed 35 kg/ m2.
* Their gestational age will be less than 20 weeks.
* All women having mild to moderate nausea and/or vomiting
* All women having singleton pregnancy

Exclusion Criteria:

Women will be excluded from the study if they have:

* Previous carpal tunnel syndrome.
* Skin abnormalities
* Acute viral disease
* Hyperemesis gravidarum.
* Previous history of nausea or vomiting before pregnancy.

Primary outcomes:
measure: Rhodes index for nausea and vomiting and retching
timeFrame: within Five days
measure: Modified pregnancy unique quantification of emesis and nausea (MPUQE)
timeFrame: within five days
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Peter Bahgat Milad
Study officials:
affiliation: Cairo University
name: Hala Emara, professor
role: STUDY_CHAIR
affiliation: Cairo University
name: Mohamed Awad, professor
role: STUDY_DIRECTOR
affiliation: Cairo University
name: Amir Arabi, professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT03079635: Breakfast and Energy Expenditure in Young Women
Official title: The Effect of Breakfast Intake on Energy Expenditure and Hunger in Young Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: University of Arkansas, Fayetteville
Sponsor class: OTHER
First posted: 2017-03-14
Enrollment: 29
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this research is to determine if body composition influence the effect of breakfast composition on postprandial (post-meal) hunger, metabolic and energy expenditure response in normal weight, overweight, and obese young women.


Eligibility criteria: Inclusion Criteria:

* BMI over 18.5
* No medication

Exclusion Criteria:

* Food allergies
* Habitual breakfast skipping (\> 5 times per week)
* Picky eater
* Dietary restrictions

Primary outcomes:
measure: Energy metabolism/expenditure
timeFrame: Four hours
Secondary outcomes:
measure: Appetite
timeFrame: Four hours
Other outcomes:
Locations:
city: Fayetteville
country: United States
facility: University of Arkansas
state: Arkansas
Study officials:
References:
Clinical trial NCT01901835: Media Diversion in Improving Quality of Life in Patients With Recurrent Gynecologic Cancers Receiving Chemotherapy
Official title: The Effects of a Media Diversion on Quality of Life in Patients Receiving Chemotherapy for Recurrent Gynecologic Cancers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Female Reproductive Cancer
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2013-07-17
Enrollment: 67
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: This randomized clinical trial studies media diversion in improving quality of life in patients with recurrent gynecologic cancers receiving chemotherapy. Media diversion may improve mood and quality of life in patients having cancer treatment.

Detailed description: PRIMARY OBJECTIVES:

I. To analyze the impact of a media-based intervention on patient mood during the receipt of chemotherapy for recurrent gynecologic cancers.

OUTLINE: are randomized to 1 of 2 arms.

ARM I: Participants are provided headphones and a tablet and choose among a selection of humorous movies. Upon the third course of chemotherapy, participants are provided a selection of non-humorous movies.

ARM II: Participants are provided headphones and a tablet and choose among a selection of non-humorous movies. Upon the third course of chemotherapy, participants are provided a selection of humorous movies.

Eligibility criteria: Inclusion Criteria:

* Subjects with pathologically-proven gynecologic malignancies
* Subjects who have previously completed primary treatment for a gynecologic malignancy
* Patients receiving chemotherapy for a recurrent gynecologic cancer at the University of Wisconsin-Madison Carbone Cancer Center (UWCCC)
* Patients must be English speaking
* Patients must have the ability to use audio media and read and understand written English

Exclusion Criteria:

* Patients unable to use audio or video media due to auditory or ocular dysfunction
* Patients unable to read written English
* Patients who are prisoners or incarcerated

Primary outcomes:
measure: Patient-reported mood using the Positive and Negative Affect Scale-Expanded Form (PANAS-X) instrument
timeFrame: Up to day 1 of course 3 of chemotherapy
Secondary outcomes:
measure: Humor Styles Questionnaire (HSQ) total score
timeFrame: Up to day 1 of course 3 of chemotherapy
measure: Brief Fatigue Inventory (BFI) total score
timeFrame: Up to day 1 of course 3 of chemotherapy
measure: Ease of use (EoS) score
timeFrame: Up to day 1 of course 3 of chemotherapy
measure: Quality of materials (QOM) score
timeFrame: Up to day 1 of course 3 of chemotherapy
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin Hospital and Clinics
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Stephen Rose
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03021135: Conventional Endoscopic Mucosal Resection vs Underwater Resection for Colorectal Non-pedunculated Colorectal Lesions
Official title: Conventional Endoscopic Mucosal Resection (With Submucosal Injection) Versus Underwater Endoscopic Mucosal Resection (Without Submucosal Injection) for Colorectal Non-pedunculated Colorectal Lesions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adenoma
Colorectal Neoplasms
Lead sponsor: Instituto do Cancer do Estado de São Paulo
Sponsor class: OTHER
Collaborators: name: University of Sao Paulo
First posted: 2017-01-13
Enrollment: 105
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: Randomized, comparative and prospective study between Conventional Endoscopic Mucosal Resection for the removal of flat or sessile colorectal lesions without previous attempt to resection.

Detailed description: This prospective randomized trial was conducted in 2 academic services: Instituto do Câncer do Estado de São Paulo and Centro de Diagnóstico em Gastroenterologia, both linked to the University of São Paulo. The clinical study was performed in accordance to the Declaration of Helsinki.

Eligibility criteria: Inclusion Criteria:

* Patients age \>18 years with sessile or flat Colorectal Lesions (measuring between 10 and 40mm), who consent to this study

Exclusion Criteria:

* Patients who refuse to participate in the study.
* Patients with pedunculated, depressed or mixed lesions.
* Patients with lesions smaller than 10 mm or larger than 40 mm.
* Patients with lesions that are inflammatory, neuroendocrine or stromal at the pathology.
* Patients with lesions that were submitted to prior attempt to endoscopic resection.

Primary outcomes:
measure: Technical success rate
timeFrame: three years
measure: Safety (incidence of complications);
timeFrame: three years
measure: Local recurrence.
timeFrame: Four years
Secondary outcomes:
measure: Resection rate en bloc
timeFrame: three years
measure: Time of resection
timeFrame: Three years
measure: Sydney resection ratio (characterized by the following equation - lesion size in millimeters
timeFrame: Three years
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Instituto do Cancer do Estado de Sao Paulo
Study officials:
affiliation: Cancer Institute of the state of São Paulo (ICESP)
name: Luciano Lenz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00466635: A Study to Assess the Safety, Tolerability, Effectiveness and Absorption of Exodif™ Tablets in Clostridium Difficile-associated Diarrhea
Official title: An Open-label Study to Assess the Safety, Efficacy and Absorption of Exodif™ (Tolevamer Potassium Sodium) Tablets in Patients With Clostridium Difficile-Associated Diarrhea
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Enterocolitis, Pseudomembranous
Diarrhea
Clostridium Difficile
Keywords: Clostridium difficile Disease
Infectious diarrhea
C. difficile
CDAD
Clostridium difficile-associated diarrhea
Clostridium difficile diarrhea
Antibiotic-Associated Colitis
Clostridium Enterocolitis
Antibiotic-Associated Diarrhea
Pseudomembranous Colitis
Clostridium difficile
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2007-04-27
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Approximately 65 patients will be entered into this study taking place in North America. The aim of this study is to evaluate the safety, efficacy and absorption of an investigational drug in patients with C. difficile-associated diarrhea (CDAD). All study related care is provided including doctor visits, physical exams, laboratory tests and study medication. Total length of participation is 6 weeks.


Eligibility criteria: Inclusion Criteria:

* The presence of CDAD at the time of enrollment
* Negative serum pregnancy test (HCG) for women of childbearing potential.

Exclusion Criteria:

* Any contraindication to oral / enteral therapy including fulminant C. difficile disease.
* Any acutely life-threatening medical conditions.
* Acute or chronic diarrhea of other cause.

Primary outcomes:
measure: Clinical Success
measure: Safety
Secondary outcomes:
measure: The extent of tolevamer absorption
Other outcomes:
Locations:
city: Modesto
country: United States
state: California
city: Honolulu
country: United States
state: Hawaii
city: Maywood
country: United States
state: Illinois
city: Baltimore
country: United States
state: Maryland
city: Worcester
country: United States
state: Massachusetts
city: West Bloomfield
country: United States
state: Michigan
city: Butte
country: United States
state: Montana
city: Cedar Knolls
country: United States
state: New Jersey
city: Neptune
country: United States
state: New Jersey
city: Syracuse
country: United States
state: New York
city: Greenville
country: United States
state: North Carolina
city: Toledo
country: United States
state: Ohio
city: Lancaster
country: United States
state: Pennsylvania
Study officials:
affiliation: Genzyme, a Sanofi Company
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT05190835: Quantification and Characterization of Foot Postoperative Edema
Official title: Quantification and Characterization of Foot Postoperative Edema - Bicentric Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgery--Complications
Lead sponsor: Clinique MEGIVAL
Sponsor class: OTHER
First posted: 2022-01-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: In foot surgery, postoperative edema is a complication making the postoperative outcome quite uncertain as to the rehabilitation of the patient. The evolution of this edema is unknown ... The means of "mastering" this edema are empirical, with little study other than cryotherapy and restraint. This study aims to study postoperative edema in a cohort of patients undergoing forefoot surgery. The follow-up will be prospective with measurement of the volume of the foot using an optical technique, during the various follow-up consultations between Day 8 and Month 6 postoperative.


Eligibility criteria: Inclusion Criteria:

* Major patient
* Patient operated on forefoot surgery
* Patient having given informed consent
* For female patients of childbearing age, not to be pregnant or likely to be during the study, not to be breastfeeding

Exclusion Criteria:

* Minor patient
* Patient deprived of his liberty or under guardianship
* Patient operated on for surgery of the forefoot other than hallux and lateral toes
* Patient unable to undergo protocol monitoring for psychological, social, family, geographic or linguistic reasons
* Patient with an underlying or concomitant pathology incompatible with inclusion in the trial, whether psychiatric or somatic
* Vulnerable people according to article L1121-6 of the CSP

Primary outcomes:
measure: Evaluate the change of volume of an operated foot to evaluate the edema.
timeFrame: Day 0 before surgery, Day 8 after surgery
measure: Evaluate the change of volume of the edema of an operated foot during the 6 months after surgery
timeFrame: Day 21, Day 45, Month 3 and Month 6 after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Polyclinique Saint Roch
city: Saint-Aubin-sur-Scie
country: France
facility: Clinique MEGIVAL
Study officials:
References:
Clinical trial NCT04471935: Speech Hero Home Therapy for Aphasia
Official title: Speech Hero: a Rhythm-based Speech Therapy App for Individuals With Aphasia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Broca Aphasia
Lead sponsor: Flint Rehabilitation Devices, LLC
Sponsor class: INDUSTRY
Collaborators: name: University of Texas
First posted: 2020-07-15
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The investigators will run an at-home usability study of a newly developed speech therapy app called Speech Hero with 10 individuals with Broca's aphasia in the chronic stage of stroke. The Speech Hero app allows users to perform rhythm-based speech exercises at home. For this study participants will be instructed to use Speech Hero for at least 10 hours over a 4-week period.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Broca's aphasia due to stroke,
* \>6 months post stroke
* sufficient motor function of the unaffected upper extremity to tap on a table while speaking

Exclusion Criteria:

* Incidence of other neurological diseases (though individuals with apraxia will be included)
* age \<85

Primary outcomes:
measure: Number of Participants That Used the Device for at Least Ten Hours Over the Course of Four Weeks
timeFrame: Immediately Post-Treatment, an average of 4 weeks
Secondary outcomes:
measure: Change in Score on Western Aphasia Battery
timeFrame: Immediately Post-Treatment, an average of 4 weeks
measure: Change in Score on Boston Naming Test
timeFrame: Immediately Post-Treatment, an average of 4 weeks
Other outcomes:
Locations:
city: Richardson
country: United States
facility: Callier Center at University of Texas Dallas
state: Texas
Study officials:
affiliation: University of Texas
name: Yune Lee, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01081535: The Effect of Intravenous (IV) Patient Controlled Analgesic (PCA) With Ketorolac or Fentanyl Combined With Caudal Block for Postoperative Analgesia in Small Children Undergoing Intravesical Ureteroneocystostomy
Official title: The Effect of IV PCA With Ketorolac or Fentanyl Combined With Caudal Block for Postoperative Analgesia in Small Children Undergoing Intravesical Ureteroneocystostomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ureteroneocystostomy
Keywords: Pediatric patients (6 months-5 years) scheduled elective ureteroneocystostomy
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2010-03-05
Enrollment: 50
Sex: ALL
Minimum age (years): 6
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The effect of IV PCA with ketorolac or fentanyl combined with caudal block for postoperative analgesia in small children undergoing intravesical ureteroneocystostomy.


Eligibility criteria: Inclusion Criteria:

* Pediatric patients scheduled for elective ureteroneocystostomy were enrolled.

Exclusion Criteria:

* History of allergy to aspirin or NSAIDs
* Peptic ulcer disease, and renal function impairment.
* And local infection foci on back, spinal anomalies
* Infectious diseases
* Neurologic disorders
* Seizures and coagulopathies were excluded for sacral epidural block.

Primary outcomes:
measure: Children's Hospital of Eastern Ontario Pain Scale, CHEOPS and Faces, Legs, Activity, Cry, and Consolability, FLACC
timeFrame: postoperative 24 hours, 48hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine, Seoul, Korea
name: Hae Keum Kil
role: PRINCIPAL_INVESTIGATOR
References: