louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00022165: Selenium in the Prevention of Cancer
Official title: Prevention Of Cancer By Intervention With Selenium
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Unspecified Adult Solid Tumor, Protocol Specific
Keywords: unspecified adult solid tumor, protocol specific
Lead sponsor: University of Surrey
Sponsor class: OTHER
First posted: 2004-03-19
Enrollment: 501
Sex: ALL
Minimum age (years): 60
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer. Selenium may be effective in preventing cancer. It is not yet known which dose of selenium may be most effective in preventing cancer.

PURPOSE: Randomized pilot study to determine the effectiveness of selenium in preventing cancer in healthy people.

Detailed description: OBJECTIVES: I. Determine whether daily supplementation with selenium significantly reduces total cancer incidence and site-specific cancer incidence in the general population. II. Determine whether this regimen has a beneficial effect on mood.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Participants are stratified according to age (60-64 vs 65-69 vs 70-74). Participants are randomized to one of four arms. Arm I: Participants receive oral placebo once daily. Arm II: Participants receive low-dose oral selenium once daily. Arm III: Participants receive moderate-dose oral selenium once daily. Arm IV: Participants receive high-dose oral selenium once daily. Treatment in all arms continues for up to 2 years in the absence of unacceptable side effects or diagnosis of cancer.

PROJECTED ACCRUAL: A total of 510 patients (170 per stratum) will be accrued for this study within 9-12 months.

Eligibility criteria: DISEASE CHARACTERISTICS: Healthy men and women No prior diagnosis of cancer except non-melanoma skin cancer

PATIENT CHARACTERISTICS: Age: 60 to 74 Performance status: SWOG 0-1 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: No active liver disease No known abnormal liver function Renal: No active kidney disease No known abnormal kidney function Other: HIV negative No diminished mental capacity that would preclude study

PRIOR CONCURRENT THERAPY: No other concurrent selenium supplements (50 ug/day or more)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Hammersmith Hospital
state: England
city: Sutton
country: United Kingdom
facility: United Kingdom Coordinating Committee on Cancer Research-ABC
state: England
city: Guildford
country: United Kingdom
facility: University Of Surrey
Study officials:
affiliation: University of Surrey
name: Margaret Rayman, DPhil
role: STUDY_CHAIR
References:
Clinical trial NCT04076865: Evaluation of the Effect Induced by Repeated Administration of Topical Local Anaesthetic (EMLA) on Itch
Official title: A Mechanistic Evaluation of the Nociceptive Desensitization Induced by Repeated Administration of Topical Local Anaesthetic Mixture of Lidocaine and Prilocaine (EMLA) in a Model of Histaminergic and Non-histaminergic Itch.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lidocaine
Itch
Lead sponsor: Aalborg University
Sponsor class: OTHER
First posted: 2019-09-03
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: In this experiment, the investigators would like to study if the repeated application of local cuaneous anaesthetic EMLA cream will reduce itch induced by small needles from the plant mucuna pruriens (also known as cowhage) and histamine (an itch proving substance formed in the body).


Eligibility criteria: Inclusion Criteria:

* Healthy men and women
* 18-60 years
* Speak and understand English

Exclusion Criteria:

* Pregnancy or lactation
* Drug addiction defined as any use of cannabis, opioids or other drugs
* Previous or current neurologic, musculoskeletal or mental illnesses
* Lack of ability to cooperate
* Current use of medications that may affect the trial
* Skin diseases
* Consumption of alcohol or painkillers 24 hours before the study days and between these
* Acute or chronic pain
* Participation in other trials within 1 week of study entry (4 weeks in the case of pharmaceutical trials)
* Known history of anaphylactic shock, or local allergy (contact dermatitis) to lidocaine, prilocaine or other local anaesthetics of the amide type.

Primary outcomes:
measure: Superficial blood perfusion
timeFrame: Change from baseline, up to three days after the first session
measure: Warm Detection Thresholds and Heat Pain Thresholds
timeFrame: Change from baseline, up to three days after the first session
measure: Pain to Supra-threshold Heat Stimuli
timeFrame: Change from baseline, up to three days after the first session
measure: Alloknesis
timeFrame: Change from baseline, up to three days after the first session
measure: Mechanical Pain Thresholds and Sensitivity
timeFrame: Change from baseline, up to three days after the first session
measure: Pain rating
timeFrame: only on day 3 (third session)
Secondary outcomes:
measure: Itch rating
timeFrame: only on day 3 (third session)
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg University
state: Nordjylland
Study officials:
affiliation: Aalborg University
name: Silvia Lo Vecchio
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02991365: Effect of Weight Loss on Brain Insulin Sensitivity in Humans
Official title: Effekt Von Gewichtsabnahme Auf Die zentralnervöse Insulinresistenz Des Menschen
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Insulin Resistance
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2016-12-13
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Obesity if known to be associated with brain insulin resistance in humans. This condition has not only implication for the brain but also for whole-body energy homeostasis. Research in rodents indicates that weight loss is able to improve insulin sensitivity of the brain. The current project will test this hypothesis in humans. Therefore, brain insulin sensitivity will be assessed by fMRI in combination with intranasal insulin administration, using an established protocol. Furthermore, effects of daily administration of insulin nasal spray (versus placebo) over 8 weeks will be assessed as secondary (exploratory) variables.


Eligibility criteria: Inclusion Criteria:

* HbA1c \<6.5%
* Age between 40 and 75 years
* No intake of antidiabetic drugs or drugs for weight reduction
* no steroid intake
* Stable medication over 10 weeks before the start of the study

Exclusion Criteria:

* Persons who wear non-removable metal parts in or on the body.
* Persons with reduced temperature sensitivity and / or increased sensitivity to heating of the body
* Cardiovascular disease can not be ruled out, e.g. manifest coronary heart disease, heart failure greater than NYHA 2, previous heart attack, stroke condition
* Persons with hearing impairment or increased sensitivity to loud noises
* People with claustrophobia
* Minors or non-consenting subjects are also excluded
* Subjects with an operation less than 3 months
* Simultaneous participation in other studies
* Neurological and psychiatric disorders
* Subjects with hemoglobin Hb \<11 g / dl
* Hypersensitivity to any of the substances used

Primary outcomes:
measure: brain insulin sensitivity
timeFrame: 30 minutes after administration of nasal insulin
Secondary outcomes:
measure: Effect of daily administration of 160 U nasal insulin or placebo over 8 weeks on body weight.
timeFrame: 8 weeks
measure: Effect of daily administration of 160 U nasal insulin or placebo over 8 weeks on glucose tolerance .
timeFrame: 8 weeks
measure: Effect of daily administration of 160 U nasal insulin or placebo over 8 weeks on body composition .
timeFrame: 8 weeks
measure: whole-body insulin sensitivity
timeFrame: 2 hours
measure: Glucose tolerance
timeFrame: 2 hours
measure: Cognitive function
timeFrame: 1 hours
Other outcomes:
Locations:
city: Tübingen
country: Germany
facility: University of Tuebingen, Department of Internal Medicine IV
Study officials:
affiliation: University of Tübingen Hospital
name: Andreas Fritsche, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01111474: Cyanoacrylate and Laser and Dentin Sensitivity
Official title: Effectiveness of Cyanoacrylate and Laser in the Treatment of Cervical Dentin Sensitivity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dentin Hypersensitivity
Dentin Sensitivity
Keywords: dentin hypersensitivity
cyanoacrylate
laser
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
Collaborators: name: Federal University of the Valleys of Jequitinhonha and Mucuri
First posted: 2010-04-27
Enrollment: 62
Sex: ALL
Minimum age (years): 12
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aimed to evaluate the effectiveness of two treatments for dental hypersensitivity: cyanoacrylate (Super Bonder®) compared with use of low intensity laser treatment (LILT). As the cyanoacrylate is a lower cost treatment, the hypothesis in investigation is if this product is equally effective as the laser treatment.

Detailed description: The present study included 62 patients (15 male and 47 females, aged 12 to 60 years). The initial cervical dentin hypersensitivity was checked throughout a thermal test (air blast). The 434 teeth included were that with a score ≥5 in a numerical scale rating of pain. Teeth were randomly assigned according quadrants (split mouth design) - 216 were allocated to LILT group and 218 for the Super Bonder® group. Thermal tests with a tetrafluoroethane spray (Endo-Ice®) and air blast were performed and considered as baseline. Pain parameters were recorded using a numerical scale rating with 24 hours, 30, 90 and 180 days after the interventions. Quality of life of the patients was also assessed with the use of OHIP-14 at baseline and after 180 days.

Eligibility criteria: Inclusion Criteria:

1. patients should be in good general and dental health;
2. present complaints of dental sensitivity to cold, sweet, acidic foods and brushing;
3. present complaints of pain in teeth located in different quadrants;
4. manifest pain or discomfort upon application of the triple syringe air jet;
5. not be in current use of desensitizing agents.

Exclusion Criteria:

1. presence of extensive restorations and carious lesions in the sensitive teeth;
2. undergoing orthodontic treatment;
3. frequent use of analgesics, antidepressants and anti-inflammatory drugs;
4. presence of gingival inflammation;
5. non-consent of patient.

Primary outcomes:
measure: Change of the Pain Sensitivity
timeFrame: Baseline and 180 days
Secondary outcomes:
measure: Quality of Life Improvement
timeFrame: Baseline and 180 days
Other outcomes:
Locations:
Study officials:
affiliation: UNIFESP - Federal University of São Paulo, Brazil
name: Olga D. Flecha, pHD student
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00326274: Clinical Safety Trial of Long-Term Intermittent Use of Helioblock® SX Cream
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Sunburn
Lead sponsor: Loreal USA
Sponsor class: INDUSTRY
First posted: 2006-05-16
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this study is to determine the safety potential of Helioblock® SX Cream as a sunscreen product in long term intermittent use conditions among pediatric subjects.. Each subject will be enrolled to participate for six months. The test product should be applied every day that outdoor activities are planned, prior to any significant sun exposure during out-door activities (such as the beach, outdoor sport activities), or whenever the subject needs to be protected against sunburn or other damage due to the sun. A minimum of 14 days test product use and sun exposure is required.


Eligibility criteria: Inclusion Criteria:

* Male or female subjects of any race or skin type, 6 months to 12 years of age inclusive, willing to use the test product intermittently for six months during outside activities

Exclusion Criteria:

* Subjects with known sensitivities to any of the study ingredients or subjects with a condition or in a situation, which in the Investigator's opinion, may suggest a significant hazard for the subject, may confound the study results, or interfere with the subject's participation in the study.
* Subjects who are pregnant or lactating

Primary outcomes:
measure: Long term safety after 6 months intermittent use in a pediatric population
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Great Neck
country: United States
facility: Research Testing Laboratories
state: New York
Study officials:
References:
Clinical trial NCT03922074: Outcomes of Colonoscopy With Non-anesthesiologist Administered Propofol
Official title: Outcomes of Colonoscopy With Non-anesthesiologist Administered Propofol. An Equivalence Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colo-rectal Cancer
Colon Adenoma
ADR
Keywords: ADR with Non-Anesthesiologist administered propofol (NAAP)
Lead sponsor: Serveis de Salut Integrats Baix Empordà
Sponsor class: OTHER
First posted: 2019-04-19
Enrollment: 630
Sex: ALL
Minimum age (years): 50
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The Efficacy and safety of Non-anesthesiologist administered propofol (NAAP) for gastrointestinal endoscopy have been widely documented although there is not information which has evaluated the outcomes of colonoscopy it self when the endoscopist has to fulfill the additional task of supervising the sedation.

Objective: To determine the equivalence of adenoma detection rate (ADR) in colorectal cancer (CRC) screening colonoscopies performed with NAAP and performed with monitored anesthesia care (MAC).

Method: Single blind non-randomized controlled equivalence trial. Patients: Adults between 50 - 69 years old from National CRC screening program (CRCSP). Intervention: The patients are blindly assigned to undergo either colonoscopy with NAAP or MAC according to the arrival of fecal occult blood test, patient's suitability for colonoscopy date and availability of places at endoscopy schedule (with NAAP or MAC).


Eligibility criteria: Inclusion Criteria:

Healthy patients -

Exclusion Criteria:

Patients with familial colorectal cancer history

-

Primary outcomes:
measure: Adenoma detection rate
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01240174: Demonstration of Near Zero Antibiotic Prescribing for Acute Bronchitis
Official title: Demonstration of Near Zero Antibiotic Prescribing for Acute Bronchitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bronchitis
Cough
Keywords: Antibiotic
Antimicrobial
Prescribing
Cough
Acute Bronchitis
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2010-11-15
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Studies show, guidelines state, and performance measures assert that antibiotic prescribing for uncomplicated acute bronchitis is inappropriate. However, clinicians prescribe antimicrobials in over 60% of the 22.5 million acute bronchitis visits in the United States each year. Previous successful interventions have only reduced the antimicrobial prescribing rate to 40% or 50%. It is unknown if the antimicrobial prescribing rate for acute bronchitis can be brought to near zero percent in actual practice while maintaining patient safety and satisfaction. The goal of this study is to develop an Electronic Health Record (EHR)-integrated algorithm for the diagnosis and treatment of adults with acute bronchitis with a goal of reducing the antibiotic prescribing rate to near zero percent.

Detailed description: We will use a multi-modal implementation - including computerized decision support, reporting tools, and clinician feedback - and quality improvement techniques to ensure adherence to the algorithm and reduce the antimicrobial prescribing rate to near zero percent. The duration of the intervention will be 4 years.

Eligibility criteria: Inclusion Criteria:

* first visit in 30 days, age 18-64, has a cough of less than 3 weeks duration

Exclusion Criteria:

* infiltrate on chest x-ray, has chronic lung disease

Primary outcomes:
measure: Antibiotic prescribing rate
timeFrame: 30 days
Secondary outcomes:
measure: Patient symptoms
timeFrame: 21 days
measure: Patient satisfaction
timeFrame: 21 days
measure: Patient safety
timeFrame: 30 days
measure: Healthcare costs
timeFrame: 30 days
measure: The capture and description of the components that had the greatest effect on the antimicrobial prescribing rate
timeFrame: 3 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital Jen Center for Primary Care
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital, Harvard Medical School
name: Jeffrey A Linder, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00343174: Intravenous Ancrod for the Treatment of Acute Ischemic Stroke Within 6 Hours After Onset of Symptoms
Official title: Multicenter Parallel Randomized Double-Blind Placebo Controlled Study of Efficacy and Safety of Intravenous Ancrod ( Arvin ) Given Within 6 Hours After the Onset of Acute Ischemic Stroke: European Stroke Treatment With Ancrod Trial ESTAT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Brain Infarction
Cerebral Ischemia
Acute Stroke
Keywords: stroke
vascular diseases
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2006-06-22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Treatment of acute stroke is still difficult and the only specific drug approved (rtPA) can only be administered if treatment starts within 3 hours after onset of symptoms. This results in a still too small number of patients treated with rtPA ( \< 15% in best clinical care institutions ). Ancrod is a differently acting biological drug which has been used for a long time but not for acute stroke treatment. STAT was the first RCT of medium size to show a significant benefit/risk ration if treatment starts within 3 hours. ESTAT was designed closely related to STAT but with a longer 6 hours window and specifically extended inclusion/exclusion criteria to avoid secondary complications possibly related to a longer time window.


Eligibility criteria: Inclusion Criteria:

* 18 years and above, both sexes
* Acute ischemic stroke with first symptoms within 6 hours of beginning
* Treatment after onset of symptoms
* SSS \< 40 at baseline ( consciousness necessary )

Exclusion Criteria:

* Clinical or CT evidence of brain hemorrhage or hemorrhagic transformation
* CT evidence of major signs of developing infarction
* Coma
* Prior strokes within 6 weeks
* Severe hypertension (\> 220 systolic \> 120 mm Hg diastolic)
* Baseline fibrinogen \< 100 mg/dL
* Recent use of thrombolytic agents
* Recent or anticipated surgery

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Univ Heidelberg Klinikum Mannheim
name: M G Hennerici, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Univ Bordeaux France
name: Jean M Orgogozo, MD
role: STUDY_DIRECTOR
References:
citation: Hennerici MG, Kay R, Bogousslavsky J, Lenzi GL, Verstraete M, Orgogozo JM; ESTAT investigators. Intravenous ancrod for acute ischaemic stroke in the European Stroke Treatment with Ancrod Trial: a randomised controlled trial. Lancet. 2006 Nov 25;368(9550):1871-8. doi: 10.1016/S0140-6736(06)69776-6.
Clinical trial NCT06779474: Laparoscopic Associating Liver Partition With Portal Vein Ligation for Staged Hepatectomy (ALPPS) for Colorectal Liver Metastases (CRLM)
Official title: Laparoscopic Associating Liver Partition With Portal Vein Ligation for Staged Hepatectomy (ALPPS) for Colorectal Liver Metastases (CRLM)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Colorectal Liver Metastases
Keywords: Colorectal liver metastases
Associating liver partition and portal vein ligation for staged hepatectomy
Laparoscopic surgery
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2025-01-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants are hospitalized at the Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China.

Brief summary: Associating liver partition and portal vein ligation for staged hepatectomy (ALPPS) is a procedure used for patients with initially unresectable colorectal liver metastases (CRLM). However, the procedure has been reported to be associated with high morbidity and mortality. Laparoscopic ALPPS has recently been reported as a minimally invasive technique that reduces perioperative risks. This study aimed to assess the safety and feasibility of full laparoscopic ALPPS in patients with CRLM.


Eligibility criteria: Inclusion Criteria:

1. Male or female subjects \> 18 years \< 75 of age.
2. ECOG performance status 0-1.
3. Histologically confirmed colorectal adenocarcinoma.
4. Imaging (CT or MRI) or pathological confirmation of liver metastasis.
5. Child-Pugh grade A liver function.
6. FLR/sTLV (standardized total liver volume) \< 30% (patients without underlying liver diseases)or \< 40% (patients with liver diseases, such as hepatic steatosis, cirrhosis, or liver damage after chemotherapy).
7. The indication of surgery is evaluated by a multidisciplinary team attended by hepatobiliary surgeons, oncologists, hepatologists and radiologists.

Exclusion Criteria:

1. Patients with unresectable extrahepatic metastatic disease (except potentially resectable lung metastases) or primary tumor.
2. Patients with severe concomitant diseases who are intolerance of major liver surgery by the judgment of the surgeon.
3. Diagnosis of other malignant tumors within the past 5 years.
4. Intention to become pregnant during the course of the study.
5. Inability to comply with the study protocol.
6. Previous enrollment in the current study.

Primary outcomes:
measure: Incidence of Adverse Events
timeFrame: within the first 90 days after the first stage of ALPPS
Secondary outcomes:
measure: Resection rate
timeFrame: within the first 14 days after the second stage of ALPPS
measure: Survival
timeFrame: 3 years
measure: Future liver remnant after surgery
timeFrame: 3 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: the Sixth Affiliated Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
References: