louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02154451: Transient Infrared Imaging for Early Detection of Skin Cancer
Official title: Transient Infrared Imaging for Early Detection of Skin Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Skin Cancer
Lead sponsor: Skinfrared LLC
Sponsor class: OTHER
First posted: 2014-06-03
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The hypothesis or study goal is to determine whether functional dynamic infrared imaging can be used for melanoma and other skin cancer screening and/or diagnosis.


Eligibility criteria: Inclusion Criteria:

* All lesion in easily accessible places
* Lesion less than 3.5 cm

Exclusion Criteria:

* Any minors
* Lesion close to vital organs

Primary outcomes:
measure: To detect skin cancers with >90% sensitivity and >50% specificity using infrared imaging
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: University of New Mexico, Derm Clinic
state: New Mexico
city: Albuquerque
country: United States
facility: Univesity of New Mexico, Derm Clinic
state: New Mexico
city: Albuquerque
country: United States
facility: University of new Mexico, Dermatology clinic
state: New Mexico
Study officials:
affiliation: Skinfrared LLC
name: Sanchita krishna, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02040051: Efficacy of Sound Insulation and Music Therapy on the Comfort of Mechanically Ventilated Patients Admitted to Intensive Care Unit
Official title: Randomized Clinical Trial to Assess the Effect of Sound Insulation and Music Therapy on the Comfort of Mechanically Ventilated Patients Admitted to Intensive Care Unit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intensive Care Units
Keywords: intensive care units
mechanical ventilation
music therapy
Lead sponsor: Althaia Xarxa Assistencial Universitària de Manresa
Sponsor class: OTHER
First posted: 2014-01-20
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to assess the effect of sound insulation and music therapy on the comfort of mechanically ventilated patients admitted to intensive care unit measured by the Bispectral Index (BIS), the Ramsay sedation scale and the Behaviour Pain Scale (BPS)


Eligibility criteria: Inclusion Criteria:

* Patients of both sexes
* Patients over 18 years old
* Patients with a level of consciousness BIS ≥ 50

Exclusion Criteria:

* Patients with withholding treatment
* Patients with partial or complete reduction of hearing in one or both ears
* Patients with altered mental states: psychosis, schizophrenia, paranoia, neurosis, etc.
* Patients with acute disease of the central nervous system: stroke, coma, encephalopathic process, etc.
* Patients with an axillary temperature \> 37.5º

Primary outcomes:
measure: Bispectral Index (BIS)
timeFrame: Up to 4 hours
measure: Ramsay sedation scale
timeFrame: Up to 4 hours
measure: Behaviour Pain Scale (BPS)
timeFrame: Up to 4 hours
Secondary outcomes:
measure: Blood pressure
timeFrame: Up to 4 hours
measure: Heart rate
timeFrame: Up to 4 hours
measure: Respiratory frequency
timeFrame: Up to 4 hours
measure: Endotracheal aspirations
timeFrame: Up to 4 hours
measure: Administration of sedatives drugs
timeFrame: Up to 4 hours
measure: Administration of vasodilator and vasoconstrictor drugs
timeFrame: Up to 4 hours
Other outcomes:
Locations:
city: Manresa
country: Spain
facility: Fundació Althaia Xarxa Assistencial Universitària de Manresa
state: Barcelona
Study officials:
affiliation: Althaia Xarxa Assistencial Universitària de Manresa
name: Marina Mateu, BSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00949351: Safety of Add on Aliskiren to Angiotensin Converting Enzyme Inhibitor (ACEI) and Angiotensin I Receptor Blocker (ARB) Treatment in Type 2 Diabetes With Nephropathy
Official title: Safety of Add on Aliskiren to ACEI and ARB Treatment in Type 2 Diabetes With Nephropathy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Type 2 Diabetes With Nephropathy
Keywords: ACEI, ARB, DN, aliskiren, proteinuria
Lead sponsor: Lerdsin General Hospital
Sponsor class: OTHER
First posted: 2009-07-30
Enrollment: 80
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Activation of renin-angiotensin plays a crucial role diabetic nephropathy. Angiotensin converting enzyme inhibitor (ACEI) and Angiotensin I receptor blocker (ARB) has been shown renoprotection whether it was used alone or in combination. Aliskiren is a direct renin inhibitor (DRI) that has shown renal benefits and safety when combined with ARB. However, to date, the safety of add on aliskiren to the combination treatment of ACEI and ARB in diabetic nephropathy patients remains to elucidate.


Eligibility criteria: Inclusion Criteria:

* Type2 diabetes patients
* Age \<30yrs-70yrs\>
* Overt proteinuria (Urinary protein creatinine ratio \> 200mg/g 2 times or more during past 6 Mo)
* Scr \< 2.5 mg/dL
* HbA1C \< 7.5
* Systolic blood pressure \> 160 mmHg without antihypertensive drugs or \> 140 with antihypertensive drug
* No history of previous cardiovascular event (Stroke, Myocardial infarction, unstable angina, hospitalization, surgical correction PVD or PVD with claudication)
* No hospitalization within 1 yr except for elective surgery

Exclusion Criteria:

* Physical examination found or suspected serious co-morbid (AF, carotid bruit, structural heart disease, cirrhosis and decompensate liver disease)
* Non adherence to protocol
* Intolerable to ACEI or ARB during run-in
* Abnormal liver function test at the run-in period
* Rapid declining renal function (SCr increase \> 40%) during run-in
* Hyperkalemia (serum K \> 5.5 mEq/L at randomization)
* Malignancy detected o
* SBP lower than 110 mmHg (at randomization)

Primary outcomes:
measure: Assess short-term safety of the combination of aliskiren 300 mg/valsartan 160 mg /enalapril 20 mg in patients with diabetic nephropathy
timeFrame: 12 wk after randomization
Secondary outcomes:
measure: Reduction of systolic blood pressure
timeFrame: 12 wk after randomization
measure: Reduction of proteinuria
timeFrame: 12 wk after randomization
measure: Change in GFR/mo
timeFrame: 12 wk after randomization
measure: Change of Serum prorenin level compare to baseline
timeFrame: 12 wk after randomization
measure: Change of Urinary TGFb1 compare to baseline
timeFrame: 12 wk after randomization
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Lerdsin General Hospital
Study officials:
References:
Clinical trial NCT06853951: Cardioprotection on Chemotherapy-Induced Cardiotoxicity
Official title: The Effect of Cardioprotective Medications on Chemotherapy-Induced Cardiotoxicity in Childhood Acute Leukemia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Cardiotoxicity
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2025-03-03
Enrollment: 30
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Arm 1 Patients will receive ACEIs oral tablets during Induction Phase by either a caregiver or caring nurse.

Arm 2 Patients will receive β-blockers oral tablets during Induction Phase by either a caregiver or caring nurse.
Primary purpose: PREVENTION

Brief summary: The aim of the present study is to evaluate the protective impact of cardioprotective medications on the chemotherapy- induced cardiotoxicity.

Detailed description: The goal of this interventional study is to evaluate the protective impact of Angiotensin-converting enzyme (ACE) inhibitors versus β-blockers on the cardiotoxicity profile of pediatric patients with acute leukemia. The impact is measured by evaluation of left ventricular ejection fraction (LVEF) by 2D echocardiography at baseline and at the end of Induction phase (42 days).

Eligibility criteria: Inclusion Criteria:

* Willingness of the legal representative of research participant to participate in the study by giving "informed consent."
* Ability to take oral medication.
* Age 2-18 years at the time of diagnosis.

Exclusion Criteria:

* Documented allergy to cardioprotective medications

Primary outcomes:
measure: Change in Left Ventricular Ejection Fraction (LVEF)
timeFrame: LVEF will be measured at Baseline and at the end of Induction Phase (42 Days)
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Pharmacy, Ain Shams University
city: Cairo
country: Egypt
facility: Faculty of Pharmacy, Ain Shams University
Study officials:
affiliation: Ain Shams University
name: Manal Hamed El-Hamamsy, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06138951: Exercise Dose-response and Protein Requirements
Official title: Dose Response Effect of Endurance Exercise on Protein Requirements of Endurance Athletes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Exercise Training
Lead sponsor: University of Toronto
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 7
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Study will investigate the impact of training volume on protein metabolism to estimate the impact on daily protein requirements of endurance athletes.


Eligibility criteria: Inclusion Criteria:

Healthy, male, endurance-trained participants who regularly run more than 40 km/week or perform endurance exercise for more than 4.5 hours/week

* Participants who have a self-reported 5-km run time of ≤23 min
* Participants who are categorized as at least "very good" based on a study by Shvartz \& Reibold (Aviat Space Environ Med. 1990 Jan;61(1):3-11), in which VO2peak is used as an index. (i.e. the participants whose VO2peak is ≥57 ml/kg/min (18-24 y), ≥54 ml/kg/min (25-29 y), ≥52 ml/kg/min (30-34 y), ≥49 ml/kg/min (35-39 y)
* Ability to complete the 16-km familiarization run on Session 2
* Aged 18-40 years old

Exclusion Criteria:

* - Inability to meet health and physical activity guidelines according to the PAR-Q+.
* Female: hormonal fluctuations associated with the menstrual cycle have been reported to alter protein metabolism during exercise and may influence specific amino acid requirements at rest; as such, the present study will test the effect of endurance exercise on protein requirements in males only to ensure a stable hormonal environment and to increase the homogeneity of the physiological response. (NOTE: we plan to test females in a future trial based off of the results obtained herein)
* Inability to adhere to any of the protocol guidelines (i.e. alcohol, caffeine consumption)
* Regular tobacco use
* Illicit drug use (e.g. growth hormone, testosterone, etc.)

Primary outcomes:
measure: Phenylalanine excretion
timeFrame: 8 hours
Secondary outcomes:
measure: Phenylalanine flux
timeFrame: 8 hours
measure: Phenylalanine oxidation
timeFrame: 8 hours
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Goldring Centre for High Performance Sport at the University of Toronto
state: Ontario
Study officials:
References:
Clinical trial NCT00487851: Comparing Endoscopic Based Stent Strategy Versus Bypass Surgery in Non-resectable Periampullary Cancer
Official title: Endoscopic Strategy Versus Surgical by Pass in Nonresectable Periampullary Cancer
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Pancreatic Neoplasms
Biliary Tract Neoplasms
Duodenal Neoplasms
Keywords: Pancreatic
cancer
Periampullay
Neoplasms
Biliary
Duodenal
Jaundice
obstruction
pancreas cancer
Pancreatic cancer
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2007-06-19
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Randomized study comparing endoscopic stent insertion strategy versus double-bypass surgery in non-resectable periampullary cancer

Detailed description: Experience shows that patients with advanced periampullary cancer suffer not only from jaundice but in 25 -30% of cases also duodenal stricture with nausea, vomiting and nutritional difficulties. Ten years ago, the only palliative treatment for these patients was a bypass operation for bile flow and intestinal passage. This operation was often associated with a high morbidity. Developments in endoscopic treatments allow palliation with lower morbidity. However, stent treatment is not free of problems like stent dysfunction. During the last ten years, anesthesia and surgical techniques have developed which allow lower postoperative morbidity compared to earlier treatments. A total of 70 patients were randomized to surgery with hepaticojejunostomy on Roux loop and gastrojejunostomy or endoscopic treatment with self-expanding metallic stent in the bile duct and so-called duodenal stent. Based on the inclusion of 70 patients, we expected a 20% difference in some of the primary variables with a power of 80%.

Eligibility criteria: Inclusion Criteria:

* Patients with a locally advanced periampullary neoplastic process with extrahepatic bile duct obstruction.
* The patient tumor burden and general condition should be such that treatment related morbidity and mortality is calculated as "reasonable" and both treatment strategies are considered "applicable".

Exclusion Criteria:

* Non consent.
* The patients' general condition will not tolerate either treatment (strategy).
* Previous laparotomy or laparoscopy.
* Life expectancy \< 3 months.
* Inability to participate (language, social, etc.)

Primary outcomes:
measure: Primary outcome consist of a composite score (i.e. number of hospitalizations, episodes of cholangitis, degree of jaundice, other complications requiring therapeutic interventions). Secondary outcome are QoL,hospital stay and health economic burden.
timeFrame: 1, 3 and 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Huddinge
country: Sweden
facility: Karolinksa university hospital
Study officials:
affiliation: Karolinska institut Huddinge
name: Farshad Frozanpor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01579851: Recovery After Sugammadex(Propofol vs Sevoflurane)
Official title: Recovery After Sugammadex(TIVA Using Propofol vs Inhalation Anesthesia Using Sevoflurane)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anesthesia
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2012-04-18
Enrollment: 71
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: Sugammadex is used to reverse of a neuro-muscular block deep. It has been reported that its administration could induce signs of recovery despite continuation of anesthetic drugs. The goal of the present study is to look is the arte of this event is different according to the primary anesthetic agent used.


Eligibility criteria: Inclusion Criteria:

* adult patients scheduled to receive general anesthesia with muscle relaxation achieved with rocuronium

Exclusion Criteria:

* Known drug allergy,
* Contra-indications to the use of propofol, remifentanil, rocuronium, sevoflurane, sugammadex
* Difficulty to use Bispectral Index monitor
* Inability to obtain a proper monitoring of muscle relaxation.

Primary outcomes:
measure: Number of patients with an increase in Bispectral Index after sugammadex injection
timeFrame: One hour after anesthesia
measure: Number of patients with occurence of clinical signs of awakening after sugammadex injection
timeFrame: One hour after anesthesia
Secondary outcomes:
measure: T4/T1 ratio after sugammadex injection
timeFrame: One hour after anesthesia
measure: Number of patients with side effects due to sugammadex injection
timeFrame: One hour after anesthesia
Other outcomes:
Locations:
city: Suresnes
country: France
facility: Hopital Foch
state: Ile de France
Study officials:
affiliation: Hopital Foch
name: Morgan Le Guen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04473651: Safety and Tolerability of Lu AG06479 in Healthy Young Men
Official title: Interventional, Randomized, Double-blind, Placebo-controlled, Sequential-group, Single-ascending Oral Dose Study Investigating the Safety, Tolerability, and Pharmacokinetic and Pharmacodynamic Properties of Lu AG06479 and Open-label Cross-over Study to Investigate Intra-subject Variability and Effect of Food in Healthy Young Men
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2020-07-16
Enrollment: 46
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the safety and tolerability of Lu AG06479 and what the body does to Lu AG06479 after swallowing single doses of the drug.

Detailed description: Part A: randomized, sequential

Part B: open-label, cross-over

Eligibility criteria: Inclusion Criteria:

* Healthy, young, non-smoking men, weight ≥60 kg, and a body mass index (BMI) ≥18.5 kg/m2 and ≤30 kg/m2 at the Screening Visit.

Other in- and exclusion criteria may apply

Primary outcomes:
measure: Number of participants with treatment emergent adverse events (Safety and Tolerability)
timeFrame: From baseline to Day 9 (Part A and B)
Secondary outcomes:
measure: AUC (0-inf) of Lu AG06479
timeFrame: From pre-dose to Day 5 (Part A and B)
measure: CL/F Lu AG06479
timeFrame: From pre-dose to Day 5 (Part A and B)
measure: Cmax Lu AG06479
timeFrame: From pre-dose to Day 5 (Part A and B)
Other outcomes:
Locations:
city: Madison
country: United States
facility: Covance
state: Wisconsin
Study officials:
affiliation: LundbeckClinicalTrials@Lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References:
Clinical trial NCT06229951: Hydrolyzed Collagen and Undenatured Collagen Type II in OA Knee
Official title: Efficacy of Hydrolyzed Collagen and Undenatured Collagen Type II in Alleviating Pain in Patients With Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteo Arthritis Knee
Keywords: Osteoarthritis
Collagen supplement
Lead sponsor: Prince of Songkla University
Sponsor class: OTHER
First posted: 2024-01-29
Enrollment: 68
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Randomized controlled trial

Targeted patients who come to receive treatment for osteoarthritis that meets the research indications will be assigned to a random group by the box of 4 randomization method, with a sequence that is randomly generated by a computer. The groups are divided into two groups:

Group 1: Patients who have taken 480 mg of hydrolyzed collagen and 20 mg of undenatured type II collagen

Group 2: Control patients will take placebo

Primary outcome : Pain level


Eligibility criteria: Inclusion Criteria:

* Age: 50-80 years old
* Medial compartment knee osteoarthritis
* Kellgren and Lawrence classification stage 2 -3
* Able to walk without walking aid

Exclusion Criteria:

* History of knee surgery on the study side
* History of intra-articular steroid injection within 6 months prior to study entry
* Systemic arthritis conditions
* Degenerative neurological and muscular conditions in the lower extremities
* Chronic kidney disease with CrCl \< 30 ml/min (glomerular filtration rate \<60 mL/min/1.73 m2)

Primary outcomes:
measure: Pain (VNRS)
timeFrame: 12 weeks
Secondary outcomes:
measure: Knee and Osteoarthritis Outcome Score (KOOS)
timeFrame: 12 weeks
measure: Rescue medication
timeFrame: 12 weeks
measure: Patient satisfaction
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Hat Yai
country: Thailand
facility: Prince of Songkla University
state: Songkhla
Study officials:
References:
Clinical trial NCT01926951: Renal Denervation Using Externally Focused Therapeutic Ultrasound
Official title: A Feasibility Study: An Evaluation of Renal Denervation Using Externally Focused Therapeutic Ultrasound With External Targeting and Tracking on Patients With Refractory Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: hypertension
Lead sponsor: Kona Medical Inc.
Sponsor class: INDUSTRY
First posted: 2013-08-21
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate the effects of renal denervation using externally focused therapeutic ultrasound with external targeting and tracking on patients with refractory hypertension.

Detailed description: This study is a prospective, multi-center trial wherein each included subject will receive the experimental externally focused ultrasound renal denervation therapy. It will be conducted on a maximum of twenty patients who meet the eligibility criteria and have signed the informed consent form.

Safety is the primary endpoint of this study. Safety will be assessed by incidence and evaluation of any serious adverse effects associated with the investigational procedure through the 52-week evaluation. Clinical utility is a secondary endpoint of this study. Clinical utility will be evaluated by comparing pre and post therapy systolic and diastolic blood pressure.

Eligibility criteria: Inclusion Criteria:

* At least 18 years of age
* Average systolic blood pressure at least 160 mmHg
* Refractory, stable hypertension despite being treated with at least three hypertensive drugs
* Two functioning kidneys, defined as eGFR \>= 45 ml/min
* At least one renal artery on each side which is greater than 4 mm.

Exclusion Criteria:

* History of nephrectomy or hydronephrosis
* Renal stenosis \> 50%
* Renal stent
* Ambulatory blood pressure monitoring 24 hour average systolic blood pressure \<= 135 mmHg
* Kidney stones which are symptomatic and/or \> 1 cm
* History of abdominal surgery within the past 6 months
* Heterogeneities in the kidneys (cysts or tumors)
* Residual pyelonephritis
* History of myocardial infarction, unstable angina pectoris, or cerebrovascular accident within the last 6 months
* Hemodynamically significant valvular heart disease
* Implantable cardioverter defibrillator, pacemaker, neurostimulator or other device incompatible with MRI
* Body weight \> 150 kilograms
* Target treatment depth \> 14 cm from the skin line
* Pregnant, nursing or intends to become pregnant during the trial period

Primary outcomes:
measure: Safety
timeFrame: 52-week post-treatment
Secondary outcomes:
measure: Clinical Utility
timeFrame: 52-week post-treatment
Other outcomes:
Locations:
city: Brno
country: Czech Republic
facility: St. Anne's University Hospital
city: Prague
country: Czech Republic
facility: Nemocnice Na Homolee Hospital
city: Aukland
country: New Zealand
facility: Mercy Angiography
Study officials:
References: