louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT07026721: Comparative Analysis of RIRS Scoring System and Resorlu Unsal Stone Score (RUSS) for Predicting Stone-free Rate After Retrograde Intrarenal Surgery
Official title: Comparative Analysis of RIRS Scoring System and Resorlu Unsal Stone Score (RUSS) for Predicting Stone-Free Rate After Retrograde Intrarenal Surgery: A Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Stones
Lead sponsor: Maharajgunj Medical Campus
Sponsor class: OTHER
First posted: 2025-06-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All the patients with renal calculi undergoing RIRS.

Brief summary: Several studies have investigated the use of scoring systems for predicting stone-free rates after RIRS. Previous research has evaluated the RIRS Scoring System, RUSS, and other similar systems in different patient populations. This study was conducted to compare RIRS scoring system and Resorlu Unsal Stone Score (RUSS) for predicting stone free rate.


Eligibility criteria: Inclusion Criteria:

* patients more than 18 years of age undergoing RIRS for renal stone
* providing informed written consent

Exclusion Criteria:

* Previous renal and ureteric surgeries
* coexisting bladder, ureteral stone

Primary outcomes:
measure: Correlation between the RIRS Scoring System and stone-free rate after Retrograde Intrarenal Surgery (RIRS), assessed using CT KUB
timeFrame: 12 months
measure: Correlation between the Resorlu-Unsal Stone Score (RUSS) and stone-free rate after Retrograde Intrarenal Surgery (RIRS), assessed using CT KUB
timeFrame: 12 months
Secondary outcomes:
measure: Stone Burden as a Predictor of Stone-Free Rate After RIRS
timeFrame: Preoperative assessment and 1 month postoperatively for stone-free status
measure: Stone Density as a Predictor of Stone-Free Rate After RIRS
timeFrame: Preoperative assessment and 1 month postoperatively for stone-free status
Other outcomes:
Locations:
city: Kathmandu
country: Nepal
facility: Department of Urology and Kidney Transplant Surgery, Tribhuvan University Teaching Hospital (TUTH), Maharajgunj, Kathmandu, Nepal
state: Bagmati
Study officials:
affiliation: Department of General Surgery Maharajgunj Medical Campus Institute of Medicine, Tribhuvan University
name: Saro Prajapati, MBBS, MS
role: STUDY_DIRECTOR
References:
Clinical trial NCT00474721: Comparison of Acetaminophen With Codeine and Ibuprofen for Children With Injuries
Official title: A Randomized Blinded Comparison of Acetaminophen With Codeine and Ibuprofen for Treatment of Acute Pain in Children With Extremity Injuries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: child
pain
analgesics
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2007-05-17
Enrollment: 68
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: We compared the pain relief of acetaminophen with codeine versus ibuprofen for children ages 5-18 years who came to the Pediatric Emergency Department with injuries to their arms or legs.

Detailed description: We conducted a randomized, double-blinded equivalence trial. Pediatric Emergency Department patients 5-18 years of age with acute extremity pain received acetaminophen-codeine (1 mg/kg as codeine) or ibuprofen (10 mg/kg). They provided Color Analog Scale pain scores at baseline and at 20, 40, and 60 minutes after medication administration. The primary outcome measured was the difference in changes in pain score at 40 minutes, compared against a previously described minimal clinically significant change in pain score of 2 cm. Additional outcomes included need for rescue medication and adverse effects.

Eligibility criteria: Inclusion Criteria:

* 5 to 18 years of age
* Spoke English as a primary language
* Complained of an extremity injury with tenderness to palpation from the clavicle or femoral neck to the distal phalanges
* Scored 5 or greater on a 10-point ordinal or Varni-Ryan pain scale administered at triage

Exclusion Criteria:

* Allergy or prior adverse reaction to acetaminophen, codeine or ibuprofen;
* Administration of any analgesic within 6 hours of presentation;
* Significant deformity or vascular insufficiency of the extremity requiring immediate treatment as determined by the treating physician;
* Inability to use the study pain instrument;
* Any laceration near the suspected injury;
* Chronic hepatic or renal disease;
* Pregnancy in the third trimester;
* Concurrent use of contraindicated medications such as monoamine oxidase inhibitors; or
* Use of central nervous system depressants such as ethanol, benzodiazepines, barbiturates, antidepressants, or recreational drugs

Primary outcomes:
measure: Change in color analog scale pain score
timeFrame: 40 minutes
Secondary outcomes:
measure: adverse reaction
timeFrame: during ED stay
measure: need for rescue medication
timeFrame: during ED stay
measure: Change in pain score
timeFrame: 20 and 60 minutes
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Rady Children's Hospital
state: California
Study officials:
affiliation: UCSD, Dept of Pediatrics and Rady Children's Hospital
name: Janet H Friday
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04281121: Omega 3 Supplementation in Children With Non Alcoholic Fatty Liver
Official title: the Effect of Omega 3 Fatty Acids Supplements on Antioxidant Capacity in Egyptian Children With Non Alcoholic Fatty Liver Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fatty Liver
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2020-02-24
Enrollment: 60
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: this is a prospective, interventional, open-label, randomized study on the efficacy of omega 3 fatty acids supplementation in Egyptian children with non-alcoholic fatty liver disease who had been selected from nutrition and outpatient clinic at Pediatric hospital, Ain Shams University


Eligibility criteria: Inclusion Criteria:

Children between 5 - 16 years old with diffusely hyper echogenic liver at ultrasonography were included in the study.

Exclusion Criteria:

* Patients with secondary causes of steatosis including total parenteral nutrition, drugs causing fatty liver disease for example steroids, hepatitis A, B, C, cytomegalovirus, Epstein-Barr virus infections, autoimmune liver disease, metabolic liver diseases, Wilson's disease, and alpha-1-antitrypsin deficiency.
* Patients currently taking fish oil supplements.
* Patients with systemic illness such as cardiac and kidney diseases.

Primary outcomes:
measure: grade of fatty liver in children
timeFrame: 3 month
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Pediatrics hospital Ain shams University
Study officials:
affiliation: Ain Shmas University
name: zeinab Kabbany, professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00789321: A Study to Evaluate Methodologies for Measuring Swelling of the Leg and Ankle (MK-0000-106)(COMPLETED)
Official title: A Randomized Clinical Trial to Evaluate the Effects of Multiple Doses of Amlodipine 10 mg on Pedal Edema Measurements in Middle-Aged and Elderly Healthy Subjects and Patient With Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hypertension
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-11-11
Enrollment: 47
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study will evaluate methodologies for measuring pedal edema associated with calcium channel blockers in middle-aged and elderly subjects and patients with hypertension.


Eligibility criteria: Inclusion Criteria:

* Patient does not have hypertension or has Stage I or II hypertension and is taking \< 3 anti-hypertension medications
* Patient is willing to discontinue all anti-hypertensive medications during study
* Patient is willing to refrain from drinking alcohol for 24 hours prior to each study visit and is willing to limit intake at other times during the study to 2 drinks per day
* Patient agrees to avoid caffeine for 24 hours prior to each study visit. At other times during study, daily caffeine intake should not exceed 4 cups of coffee (or equivalent)
* Patient will avoid strenuous physical activity during study
* Patient is a nonsmoker or has not smoked for the last 3 months

Exclusion Criteria:

* Patient has metal implants in the leg or artificial limbs
* Patient has had a lower limb amputation, malformation, alterations in leg muscles, or a history of musculoskeletal disease
* Patient has used oral contraceptive pills or hormone replacement therapy within 3 months of screening
* Patient has a history of stroke or seizures
* Patient has a history of cancer, except that which was treated at least 10 years prior to screening and shows no evidence of recurrence

Primary outcomes:
measure: Change From Baseline in Segmental Bioimpedance Measurements at 10 Kilohertz (KHz) at Week 2
timeFrame: Baseline and 2 weeks
Secondary outcomes:
measure: Change From Baseline in Foot Volume by Water Displacement (Weight of Water Displaced) at Week 2
timeFrame: Baseline and 2 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Schoeller DA, Alon A, Manekas D, Mixson LA, Lasseter KC, Noonan GP, Bolognese JA, Heymsfield SB, Beals CR, Nunes I. Segmental bioimpedance for measuring amlodipine-induced pedal edema: a placebo-controlled study. Clin Ther. 2012 Mar;34(3):580-92. doi: 10.1016/j.clinthera.2012.01.018. Epub 2012 Mar 3.
Clinical trial NCT01373021: The Effect of Dexmedetomidine on Postoperative Analgesia
Official title: Assessment of the Effect of Dexmedetomidine in the Management of Postoperative Pain When Combined With Fentanyl in the Patient-controlled Analgesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Colon Cancer, Rectal Cancer
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Pharmbio Korea Co., Ltd.
First posted: 2011-06-14
Enrollment: 95
Sex: ALL
Minimum age (years): 20
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to determine whether additional Dexmedetomidine to patient controlled analgesia can reduce fentanyl consumption.


Eligibility criteria: Inclusion Criteria:

* Elective surgery for colon cancer

Exclusion Criteria:

* Liver disease
* Kidney disease
* Allergy for study drugs
* Inability to receive patient controlled analgesia

Primary outcomes:
measure: total amount of administered fentanyl
timeFrame: during first 24 hours after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul national university hospital
Study officials:
References:
Clinical trial NCT01752621: Epidemiology of Acromegaly in Denmark 1991-2010
Official title: Incidence and Late Prognosis of Acromegaly in Denmark From 1991 - 2010: Twenty Years of Medical Treatment
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acromegaly
Keywords: Acromegaly
mortality
morbidity
incidence
prevalence
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2012-12-19
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The entire danish population in the period 1991-2010 by means of national register

Brief summary: Aim: To assess the incidence rate, morbidity and mortality of acromegaly in Denmark.

Detailed description: Background: Acromegaly is a rare disease caused by GH hypersecretion from a pituitary adenoma. The annual incidence is estimated to be 3-5/million with a prevalence of 100 - 150/million. The incidence rate is however uncertain since no nationwide surveys exist. If left untreated or poorly controlled the condition is associated with progressive morbidity and an excess mortality. The primary treatment is surgery, which however only provides a cure rate of ≈ 50 -60% due to the size of the tumour. The second line treatment today is medical treatment with slow release formulations of somatostatin analogs (SA) and, more recently, a specific GH antagonist.

Accurate data on incidence rates and outcome of treatment are of obvious importance in order to provide optimal and evidence-based treatment for the disease. This is particularly relevant in light of the availability of new and effective treatment modalities such as the GH antagonist, the proper place of which in the treatment algorithm still remains controversial.

Denmark holds a unique position in terms of epidemiological studies due to the existence of well organized databases which include all its inhabitants. A recognised problem with epidemiological surveys from specialised centres is whether the figures are representative for the general population. A nationwide Danish study will profit from the fact that every Danish citizen holds a unique ID number that makes it easy to retrieve and combine pertinent data regarding health, disease and death from different registries. The investigators have previously used this for a landmark survey of another rare endocrine disease, i.e. Cushing's syndrome. This publication has been cited more than 100 times.

Aim: To assess the incidence rate, morbidity and mortality of acromegaly in Denmark.

Eligibility criteria: Inclusion Criteria:

* diagnosed with acromegaly in years 1991-2010

Primary outcomes:
measure: Mortality of acromegaly
timeFrame: 3 years
Secondary outcomes:
measure: • Incidence of Acromegaly
timeFrame: 3 years
measure: prevalence rates of Acromegaly
timeFrame: 3 years
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Aarhus
country: Denmark
facility: Jakob Dal
Study officials:
affiliation: MEA AUH
name: Jens Otto Jorgensen, professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT06885021: Evaluate the Safety and Efficacy of HDM1002 Tablets in Chinese Overweight and Obese Adults
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Trial to Evaluate the Safety and Efficacy of HDM1002 Tablets in Chinese Overweight and Obese Adults
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Overweight and Obesity
Lead sponsor: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-03-19
Enrollment: 780
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: A Phase 3 Trial to Evaluate the Safety and Efficacy of HDM1002 Tablets in Overweight and Obese Adults


Eligibility criteria: Inclusion Criteria:

* BMI≥28 but \< 40.0 kg/m2 at screening or randomization，or BMI≥24.0 kg/m2 but \< 28 kg/m2 with any of the following:

  1. Hypertension
  2. Dyslipidemia
  3. Obstructive sleep apnea syndrome
  4. MASH
  5. Pain in the weight-bearing joints
* At least one previous failure to lose weight through lifestyle modification was defined as \< 5% weight loss after ≥3 months of lifestyle modification

Exclusion Criteria:

* Weight change ≥5% as reported or documented.
* Previous diagnosis of type 1, type 2, or any other type of diabetes.
* Diagnosis of overweight or obesity due to other diseases or medications.
* History or family history of medullary thyroid carcinoma, C cell hyperplasia, or multiple endocrine neoplasia type 2.
* Have diseases or conditions that affect gastric emptying or gastrointestinal absorption of nutrients, such as bariatric surgery or other gastrectomy, irritable bowel syndrome, dyspepsia, chronic pancreatitis, etc. Or a history of acute pancreatitis or acute gallbladder disease within 3 months before signing ICF.
* GLP-1R agonist use within 6 months prior to signing ICF.
* Use of hypoglycemic drugs within 3 months before signing ICF.

Primary outcomes:
measure: Percentage Change From Baseline in Body Weight
timeFrame: 44weeks
measure: Percentage Change of Participants Achieving Weight Loss ≥ 5%
timeFrame: 44weeks
Secondary outcomes:
measure: Percentage Change of Participants Achieving Weight Loss ≥ 10% and ≥ 15%
timeFrame: 44weeks
measure: Change From Baseline in Waist Circumference
timeFrame: 44 weeks, 52 weeks
measure: Percentage Change of Participants Achieving Weight Loss ≥ 5% , ≥ 10% and ≥ 15%
timeFrame: 52 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01135121: Role of Diaphragm Fatigue in Weaning From Mechanical Ventilation
Official title: Pilot Study on the Role of Diaphragm Fatigue in Weaning From Mechanical Ventilation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Weaning
Respiratory Muscle Function
Lead sponsor: University Medical Center Nijmegen
Sponsor class: OTHER
First posted: 2010-06-02
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ICU patients weaning from mechanical ventilation

Brief summary: The purpose of this study is to determine whether the diaphragm develops contractile fatigue during a weaning trial and if this is associated with weaning failure.


Eligibility criteria: Inclusion Criteria:

* age \> 18 year
* mechanical ventilation for at least 3 days
* the treating physician judges the patient to be ready to be weaned from the ventilator
* informed consent

Exclusion Criteria:

* pre-existent muscle disease (congenital or acquired) or diseases / disorders know to be associated with myopathy including auto-immune diseases.
* upper airway / esophageal pathology (i.e. recent surgery, esophageal varices, diaphragmatic hernia)
* recent (\< 1 month) nasal bleeding
* phrenic nerve lesions

Primary outcomes:
measure: Fatiguability of the diaphragm
timeFrame: Multiple measurements within 24 hours after start of weaning trial
Secondary outcomes:
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud University Nijmegen Medical Center
state: Gelderland
Study officials:
References:
Clinical trial NCT00496821: Intranasal ALN-RSV01 Administered to Adult Volunteers Experimentally Inoculated With Respiratory Syncytial Virus
Official title: A Study to Investigate the Safety and Efficacy of Intranasal ALN-RSV01 Administered to Adult Volunteers Experimentally Inoculated With Respiratory Syncytial Virus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Respiratory Syncytial Virus Infections
Keywords: Respiratory Syncytial Virus
Lead sponsor: Alnylam Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2007-07-04
Enrollment: 88
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the safety, tolerability and efficacy of intranasal ALN-RSV01 versus placebo, administered once daily for 5 days to a healthy male volunteers experimentally inoculated with RSV


Eligibility criteria: Inclusion Criteria:

* Availability for the required study period (including the inpatient phase, ability to comply with study requirements and attend follow-up study visits
* Able to provide written consent for participation after reading the Consent Form and after having adequate opportunity to discuss the study with an investigator or qualified deputy.
* Good general health status as determined by a screening evaluation no greater than 120 days but not less than 14 days prior to enrollment and admission to the research unit
* Low titers of RSV neutralizing antibody measured during screening.

Exclusion Criteria:

* Significant acute or chronic, uncontrolled medical illness
* Presence of household member or close contact to someone who:

  * Is less than three(3) years of age
  * Has a known immunodeficiency
  * Is receiving immunosuppressant drugs
  * Is undergoing or soon to undergo cancer chemotherapy within 28 days of enrollment
  * Has diagnosed emphysema, chronic obstructive pulmonary disease(COPD), or severe lung disease
  * Is elderly and residing in a nursing home, or
  * Has received an organ transplant
* Females are not eligible for this study
* Evidence of or history of drug or alcohol abuse (within the past 6 months) or positive urine drug or alcohol screen

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Safety and tolerability of intranasal ALN-RSV01 versus placebo, administered in a multiple-dose schedule (once daily for 5 days) to healthy adult volunteers experimentally inoculated with respiratory syncytial virus
timeFrame: 28 days
Secondary outcomes:
measure: Determining the impact of ALN-RSV01 on symptoms of RSV infection, RSV infection rate based upon measures of viral load, and understanding the potential antiviral activity of ALN-RSV01
timeFrame: 28 days
Other outcomes:
Locations:
city: Cambridge
country: United States
facility: Alnylam Pharmaceuticals
state: Massachusetts
Study officials:
affiliation: Alnylam Pharmaceuticals
name: Akshay Vaishnaw, MD PhD
role: STUDY_DIRECTOR
References: