louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04085289: A Study of Galcanezumab (LY2951742) in Healthy Chinese Participants
Official title: A Randomized, Placebo-Controlled, Single-Dose Study to Assess the Pharmacokinetics, Safety, and Tolerability of Galcanezumab in Healthy Chinese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2019-09-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to assess how fast galcanezumab gets into the blood stream and how long it takes the body to remove it. Information about side effects will be collected. The study is open to healthy Chinese participants. It will last up to about 24 weeks.


Eligibility criteria: Inclusion Criteria:

* Participants who are native Chinese (all 4 biological grandparents and both biological parents to be of Chinese origin)
* Participants who are overtly healthy males or females, as determined by medical history and physical examination

Exclusion Criteria:

* Participants who are currently enrolled in a clinical study involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study
* Participants who have participated, within the last 30 days, in a clinical study involving an investigational product. If the previous investigational product has a long half-life, 5 half-lives or 30 days (whichever is longer) should have passed
* Participants who have received treatment with any CGRP (calcitonin gene related peptide) antibody (including galcanezumab), or antibody against CGRP receptor (including erenumab), or have received biologic agents (such as monoclonal antibodies) within 4 months or 5 half-lives (whichever is longer) prior to dosing
* Participants who have a history of multiple or severe allergies or has had an anaphylactic reaction to prescription or non-prescription drugs or food
* women who are lactating
* Participants who show evidence of positive human immunodeficiency virus antibodies, or positive hepatitis C antibody, or positive hepatitis B surface antigen, or active tuberculosis

Primary outcomes:
measure: Pharmacokinetics: Maximum Concentration (Cmax) of Galcanezumab
timeFrame: 8, 24, 48, 96, 120, 168, 216, 264, 336, 504, 672, 1008, 1344, 1680, 2016, 2688, 3360 hours post-dose
measure: Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of Galcanezumab
timeFrame: 8, 24, 48, 96, 120, 168, 216, 264, 336, 504, 672, 1008, 1344, 1680, 2016, 2688, 3360 hours post-dose
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: HuaShan Hospital Affiliated To Fudan University
state: Shanghai
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT04666389: The Role of Statins in the Prevention of Contrast-induced Acute Kidney Injury in Patients With Cardiovascular Diseases
Official title: The Role of Statins in the Prevention of Contrast-induced Acute Kidney Injury in Patients With Cardiovascular Diseases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contrast-induced Acute Kidney Injury
Cardiovascular Diseases
Keywords: contrast-induced acute kidney injury
contrast-associated acute kidney injury
contrast media
cardiovascular diseases
computer tomography
Lead sponsor: I.M. Sechenov First Moscow State Medical University
Sponsor class: OTHER
First posted: 2020-12-14
Enrollment: 150
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 aim of the study is to assess the role of statins and different dosage regimens in the prevention of contrast-induced acute kidney injury in patients with cardiovascular diseases requiring intravenous contrast media administration before computer tomography


Eligibility criteria: Inclusion Criteria:

* Written informed consent
* Indications for computer tomography with intravenous contrast media administration
* Cardiovascular diseases (arterial hypertension, arrhythmia etc)

Exclusion Criteria:

* Pregnancy
* Statin therapy before inclusion in the study
* Acute coronary syndromes
* Contraindications for statins administration
* Patients with chronic kidney disease stages 4-5
* Contraindications for computer tomography with contrast media administration
* Nephrotoxic drugs use (NSAIDS, vancomycin etc)

Primary outcomes:
measure: Contrast-induced acute kidney injury
timeFrame: 48-72 hours after contrast media administration
Secondary outcomes:
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Sechenov University
Study officials:
affiliation: Sechenov University
name: Olga Mironova, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vasin AA, Mironova OI, Fomin VV. [The atorvastatin effects on the prevention of contrast-induced acute kidney injury during computed tomography with contrast media]. Ter Arkh. 2022 Oct 24;94(9):1057-1061. doi: 10.26442/0403660.2022.09.201845. Russian.
Clinical trial NCT01303289: Clinical Evaluation of a Normoproteic Diet
Official title: Clinical Evaluation of a Normoproteic Diet With Ultra High Temperature Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Severe Insufficient Nutrition
Keywords: Total Enteral Nutrition
Severe insufficient nutrition
T-Diet plus Standard
Lipidic profile
Quality of life
Lead sponsor: Vegenat, S.A.
Sponsor class: INDUSTRY
First posted: 2011-02-24
Enrollment: 60
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The main objective of this trial is the clinical evaluation of a normoproteic diet, when this diet is used for total enteral nutrition in geriatric people.

For 3 months,all the participants in the study will receive only tube feeding: The experimental group will receive the commercial preparation to evaluate (T-Diet Plus ®, Vegenat SA) and the control group will receive a standard diet (Jevity ®, Abbott Laboratories).

Detailed description: The project includes:

* Product tolerance study: gastrointestinal and metabolic complications related to the product administration.
* The monitoring of the intervention, and clinical and nutritional evaluation of the participants, including anthropometry, quality of life related to the health and clinical and nutritional status analytical evaluation (hematology and biochemistry).
* The determination of the major biochemical variables related to the lipid profile and assessment of the antioxidant defense system, and also certain markers of metabolic syndrome and associated cardiovascular risk.

Eligibility criteria: Inclusion Criteria:

* Patients over 65 years old, of both sex, receiving total enteral nutrition by tube.
* Admitted to medically supervised institutions (homes, health centers).
* Requirement for total enteral nutrition standard, at least 3 months.
* Acceptance volunteer to participate in the study by signing the written informed consent (approved by the Ethics Committee of University Hospital Virgen de las Nieves).

Exclusion Criteria:

* Patients who receive drugs with lipid composition.
* Unstable clinical situation.
* Patients with terminal illness.
* Refusal or physical or mental inability to cooperate in the study.
* Participating in another study.
* Other causes: social causes, humanitarian, non-cooperation, etc..

Primary outcomes:
measure: Nutritional status evaluation
timeFrame: 6 months
Secondary outcomes:
measure: Specific parameters measure
timeFrame: 6 months
Other outcomes:
Locations:
city: Granada
country: Spain
facility: Department of Biochemistry and Molecular Biology II. University of Granada
Study officials:
affiliation: Departament of Biochemistry and Molecular Biology II. University of Granada
name: Ángel Gil, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03393689: RGD PET/MRI in Sporadic Vestibular Schwannoma
Official title: Kan tumorvækst Forudsiges Ved RGD-PET/MR af Vestibularis Schwannomer?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Acoustic Neuroma
Keywords: 68Ga-NODAGA-E[c(RGDyK)]2
Angiogenesis PET/MR
Acoustic Neuroma
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2018-01-08
Enrollment: 40
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: DIAGNOSTIC

Brief summary: The aim of this non-randomised, prospective study is to investigate the applicability and prognostic value of angiogenesis PET/MR with the radioligand 68Ga-NODAGA- E\[c(RGDyK)\]2 in patients with sporadic Vestibuarl Schwannomas.

Detailed description: The radioligand 68Ga-NODAGA- E\[c(RGDyK)\]2 targets the Arg-Gly-Asp (RGD) sequence known to bind with the αvβ3 integrin that is expressed on the surface of angiogenic blood vessels or tumor cells. The radioligand can be used to visualize tumor angiogenesis using PET/MR.

A total of 40 patients diagnosed with sporadic vestibular schwannomas will be subjected to an angiogenesis-PET/MR scan. Follow-up MR-only scan will be performed (from the time of the angiogenesis PET/MR) minimum 2 months later in regards to calculate growth rate. The uptake of 68Ga-NODAGA-E\[c(RGDyK)\]2 (Standardized Uptake Values, SUVmax) in tumor lesions will be quantified as Standardized Uptake Values (SUVmax/SUVmean) and compared with PFS, DSS and OS (dichotomized above/below median SUVmax and analyzed by Kaplan-Meier).

Eligibility criteria: Inclusion Criteria:

* Patients \> 18 years with MRI verified sporadic vestibular schwannomas
* Patients \> 18 år whom max has been in watchful waiting regime in 12 months and/or max. received 1 follow-up MRI scan.
* Must be able to read and understand the patient information in Danish and to give informed consent

Exclusion Criteria:

* Pregnancy
* Breast-feeding
* Weight more than the maximum weight limit for the PET/MR bed of the scanner (140 kg)
* History of allergic reaction attributable to compounds of similar chemical or biologic composition to 68Ga-NODAGA-E\[c(RGDyK)\]2
* Recent systemic treatment with steroids
* Hormone treatment incl. birth control pills.
* Claustrofobia
* Non-MRI compatible implants.

Primary outcomes:
measure: Angiogenesis PET/MR imaging of patients with sporadic Vestibular Schwannomas
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Otolaryngology, Head and Neck Surgery & Audiology, Rigshospitalet
Study officials:
affiliation: Rigshospitalet, Denmark
name: Hjalte C.R. Sass, MD, Ph.d.-Fellow
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00792389: Study of the Use of Humidified Warmed Gas and the Effect on Post-Operative Pain in Laparoscopic Cholecystectomies
Official title: Randomised Controlled Trail of Warmed Humidified Insufflation Versus Cold Non-Humidified Insufflation in Elective Laparoscopic Cholecystectomies: Does This Reduce Post-Operative Pain?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Gallstone
Keywords: Gallstones
Gallbladder
Cholecystectomy
Gallstone disease
Lead sponsor: Pennine Acute Hospitals NHS Trust
Sponsor class: OTHER
First posted: 2008-11-17
Enrollment: 200
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: Double blind RCT comparing elective laparoscopic cholecystectomy using warmed, humidified gas (new) against laparoscopic cholecystectomy with cool, dry gas (usual). Sample size of 200 patients. Outcome measures are postoperative opiate analgesia use, and post operative numerical pain scores.


Eligibility criteria: Inclusion Criteria:

* elective laparoscopic cholecystectomy
* 18 years of age or over

Exclusion Criteria:

* under 18 years of age
* prisoners
* converted to open operation
* secondary invasive procedure during operation
* unable to give consent for whatever reason

Primary outcomes:
measure: Total post operative opiate analgesia - morphine equivalent dose.
timeFrame: 1 day
Secondary outcomes:
measure: Subjective post operative pain as defined on numerical pain scales
timeFrame: 1 day
Other outcomes:
Locations:
city: Oldham
country: United Kingdom
facility: Royal Oldham Hospital
state: Lancashire
Study officials:
affiliation: Pennine Acute Hospital NHS Trust
name: David Flook, MBChB
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02072889: Optimal Neck Angle for Internal Jugular Cannulation
Official title: Optimal Angle For Internal Jugular Cannulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgery
Keywords: Cardiac Surgery
Internal Jugular Cannulation
Optimal Neck Angle
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
First posted: 2014-02-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Measurements will be made between the internal jugular vein and the carotid artery using an ultrasound machine as the subjects is asked to move and position his or her neck in various positions.

It is hypothesized that by movements of the neck the investigators can maximize the distance between the internal jugular vein and the carotid artery to decrease inadvertent cannulation of the carotid artery to improve patient safety

Detailed description: Patients will be asked to participate in this trial if they are scheduled for surgery and they will have their neck repositioned in several ways using an ultrasound machine to measure the distance between the internal jugular vein and the carotic artery to determine maximal distance in order to insert a catheter prior to surgery

Eligibility criteria: Inclusion Criteria:

Male and Females 18 years through 98 Scheduled for cardiac surgery Requires internal cannulation for their scheduled operative procedure -

Exclusion Criteria:

Individuals who refuse participation Subjects who already have had the internal jugular cannulated (line already present) History of carotid surgery History of Neck Surgery Individuals under 18 years of age

-

Primary outcomes:
measure: Find Optimal Angle for internal jugular cannulation
timeFrame: Approximately 4 years
Secondary outcomes:
measure: Find Optimal Neck Angle
timeFrame: Approx 4 years
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: Robert Wood Johnson University Hospital
state: New Jersey
Study officials:
affiliation: Rutgers Robert Wood Johnson Medical School
name: Vincent DeAngelis, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05872789: Impact of Diazepam 1% Oral Gel Efficacy in Burning Mouth Syndrome
Official title: Impact of the Efficacy of Diazepam 1% Oral Gel in Burning Mouth Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Burning Mouth Syndrome
Lead sponsor: University of Catania
Sponsor class: OTHER
First posted: 2023-05-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The main objective of this study was to evaluate the efficacy of Diazepam 1% oral gel over placebo in the management of BMS
Primary purpose: TREATMENT

Brief summary: Burning mouth syndrome (BMS) is a syndrome characterized by burning and persistent oral pain, ranging from mild to intense, in the absence of organic disorders of the oral cavity and with a major impact on the quality of life of the sufferer. Although several etiological theories have been proposed to explain BMS, none has been universally accepted to date, and its origin remains unclear. Currently, several scientific evidences would suggest that underlying BMS would be alterations in certain neuropathic mechanisms.

The purpose of the study is to evaluate the efficacy of Diazepam 1% oral gel in the treatment of burning mouth syndrome.

Detailed description: A double-blind placebo-controlled trial is conducted in order to evaluate the efficacy of Diazepam 1% oral gel and determine the statistical significance of the outcome variables. 40 patients with BMS, in two groups:

* case group with Diazepam 1% oral gel (Galenic formulation)
* control group with placebo in oral gel formulation

Follow-up of 2 months

Eligibility criteria: Inclusion Criteria:

* clinically diagnosed with BMS who reported a history of continuous oral burning pain for more than 4 months with no clinical signs that could justify the syndrome

Exclusion Criteria:

* • clinically diagnosed with BMS who reported a history of continuous oral burning pain for more than 4 months with clinical signs that could justify the syndrome

Primary outcomes:
measure: Evolution of burning mouth
timeFrame: 2 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Catania
country: Italy
facility: AOU Policlinico G. Rodolico
Study officials:
affiliation: University of Catania
name: Gaetano Isola
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00317889: Compaction Total Hip Arthroplasty (THA) Bilateral
Official title: Compaction THA Bilateral
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coxarthrosis
Keywords: THA
Lead sponsor: Northern Orthopaedic Division, Denmark
Sponsor class: OTHER
First posted: 2006-04-25
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a prospective, randomized study comparing two different bone preparation techniques for insertion of a porous coated titanium cementless femoral stem. Patients receiving a bilateral total hip replacement are randomized to conventional broaching on one side and compaction on the other side.

Hypothesis: Compaction results in significantly less stem migration \[evaluated by radiostereometric analysis (RSA)\], less peri-prosthetic bone mineral density (BMD) loss \[evaluated by dual energy x-ray absorptiometry (DEXA)\], and a higher Harris hip score after two years.


Eligibility criteria: Inclusion Criteria:

* Patients with primary arthritis in the hip
* Patients with sufficient bone density to allow uncemented implantation of a femoral component
* Informed patient consent in writing

Exclusion Criteria:

* Patients with neuromuscular or vascular disease in the affected leg
* Patients found upon operation to be unsuited for uncemented acetabulum component
* Patients who regularly take non-steroidal anti-inflammatory drugs (NSAIDs) and cannot interrupt intake for the postoperative phase of the study
* Patients with fracture sequelae
* Female patients of childbearing capacity
* Hip joint dysplasia
* Sequelae to previous hip joint disorder in childhood.

Primary outcomes:
measure: Radiostereometric analysis
timeFrame: 5 and 10 years follow-up
Secondary outcomes:
measure: Periprosthetic bone mineral density
timeFrame: 5 years follow-up
Other outcomes:
measure: Questionnaire
timeFrame: 5 years follow-up
Locations:
city: Aalborg And Farsø
country: Denmark
facility: Northern Orthopaedic Division
state: Aalborg
Study officials:
affiliation: Northern Orthopaedic Division
name: Søren Kold, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03927989: Tobacco Treatment in the Context of Lung Cancer Screening
Official title: Tobacco Treatment in the Context of Lung Cancer Screening
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2019-04-25
Enrollment: 48
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The proposed study will test a medication plus text messaging intervention specifically designed for lung cancer screening patients. Half of the patients will receive standard of care, and half will receive the treatment intervention.

Detailed description: Screening for lung cancer at earlier, more treatable stages has the potential to reduce mortality from the U.S.'s most deadly cancer. Annual lung cancer screening with low-dose computed tomography is now recommended for high risk individuals based on age and smoking history. This study will evaluate a smoking cessation intervention for lung cancer screening patients. We will evaluate quit rates after a standard intervention (brief counseling session at time of lung cancer screening) versus a dual nicotine replacement therapy (NRT) and gain-framed text messaging intervention.

Eligibility criteria: Inclusion:

1. 55 years or older
2. 30 pack year history of smoking
3. current smoker (defined as breath carbon monoxide\>6ppm)
4. willing to be randomized
5. English speaking

Exclusion:

1. unstable psychiatric/medical conditions such as suicidal ideation, acute psychosis, severe alcohol dependence, substance abuse, or dementia
2. in the immediate (within 2 weeks) post myocardial infarction period
3. serious arrhythmias
4. unstable angina pectoris
5. hemodynamically or electrically unstable
6. currently taking part in any other tobacco treatment program or using cessation medication (i.e., taking NRT or other cessation medications, enrolled in the Quitline, in another drug study).

Primary outcomes:
measure: End of Treatment Abstinence Rates
timeFrame: Week 8 (end of treatment)
Secondary outcomes:
measure: End of Study Abstinence Rates
timeFrame: 3-month follow-up
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Alana Rojewski, PhD
role: PRINCIPAL_INVESTIGATOR
References: