louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01437592: Investigating the Pharmacokinetic Properties of NN1250 in Healthy Chinese Subjects
Official title: A Trial Investigating the Pharmacokinetic Properties of NN1250 in Healthy Chinese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Healthy
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2011-09-21
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This trial was conducted in Asia. The aim of this trial was to investigate the pharmacokinetic properties (the effect of the investigated drug on the body) of NN1250 (insulin degludec) in healthy Chinese subjects.


Eligibility criteria: Inclusion Criteria:

* Male or female Chinese subject aged 18-45 years (both inclusive)
* Considered generally healthy upon completion of medical history, physical examination, vital signs and electrocardiogram (ECG), as judged by the Investigator
* Body mass index 19.0-24.0 kg/m\^2 (both inclusive)

Exclusion Criteria:

* A history of any illness that, in the opinion of the Investigator, might confound the results of the trial or pose risk in administering the trial product to the subject
* Subject who has donated any blood or plasma in the past month or more than 400 mL within 3 months prior to screening
* Not able or willing to refrain from smoking during the inpatient period

Primary outcomes:
measure: Area under the serum insulin degludec concentration-time curve
timeFrame: From 0 to 120 hours after single dose
Secondary outcomes:
measure: Maximum observed serum insulin degludec concentration
timeFrame: 0-24 hours (derived on treatment day 1).
measure: Time to maximum observed serum insulin degludec concentration
timeFrame: 0-24 hours (derived on treatment day 1).
Other outcomes:
Locations:
city: Beijing
country: China
facility: Novo Nordisk Investigational Site
state: Beijing
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Pei H, Jiang J, Bardtrum L, Haahr H. Pharmacokinetic properties of insulin degludec in healthy Chinese subjects. Diabetes Manag 2019;9(1):20-7
Clinical trial NCT06598592: Video Emergency Calls of Bystanders
Official title: Video Emergency Calls of Bystanders - a Simulation Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Audio-Emergency Call
Video-Emergency Call
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Emergency center dispatchers often face the challenge that emergency calls typically provide only verbal information. However, many first responders use smartphones, which could enable the option for video calls during emergencies. Leveraging this technology could offer control center staff additional insights, potentially transforming the way they manage emergency situations. Despite this, the impact of video emergency calls on call duration and user experience remains largely unexplored.

In this project, 20 control center employees will undergo a one-hour training session on a video emergency call system. After the training, each dispatcher will handle four simulated emergency calls-two via audio and two via video. To facilitate this, 80 first responders will be recruited from public spaces, such as shopping centers. These responders will face simulated emergencies, including epileptic seizures, shortness of breath, forehead lacerations, or injuries to the upper extremities with minor bleeding. Professional medical actors will simulate the emergencies, and the responders will be tasked with making either an audio or video emergency call.


Eligibility criteria: Inclusion Criteria:

* 18-70 years
* User of a smartphone
* German Language

Exclusion Criteria:

* EMS personnel

Primary outcomes:
measure: Duration of the Emergency Call
timeFrame: Up to 10 Minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
References:
Clinical trial NCT00547092: Study For Which Treatment, Tadalafil or Sildenafil, is Preferred For Problems Getting or Maintaining an Erection
Official title: A Multicenter Open-Label Study to Determine Treatment Preference of Tadalafil (IC351, LY450190) or Sildenafil Citrate in the Oral Treatment of Erectile Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Impotence
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: ICOS Corporation
First posted: 2007-10-22
Enrollment: 386
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To determine if men prefer tadalafil or sildenafil for getting and keeping an erection after treatment with both drugs.


Eligibility criteria: Inclusion Criteria:

* History of erection problems
* Never taken treatments known as PDE5 inhibitors for erection issues
* Abstain from using any other erection treatments during the study
* Anticipate a monogamous female sexual relationship
* Must be able to make required sexual intercourse attempts

Exclusion Criteria:

* History of other primary sexual disorder
* Treatment with nitrates
* Have a penile implant or clinically significant penile deformity
* History of certain heart problems
* Do not meet certain lab value reference ranges

Primary outcomes:
measure: Preference Assessment measured by the Treatment Preference Question
timeFrame: 26 weeks
Secondary outcomes:
measure: Compare efficacies of the two drugs as measured by the Erectile Function domain of IIEF and Questions 2 and 3 of the SEP diary.
timeFrame: 0, 12, and 26 weeks
measure: Assess sexual encounters attributes measured by the PAIRS.
timeFrame: 0, 12, and 26 weeks
measure: Measure adverse events through the Side Effect Question.
timeFrame: 12 and 26 weeks
Other outcomes:
Locations:
city: Plymouth
country: United Kingdom
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon- Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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 NCT00032292: Research Study of Visilizumab for Treatment of Acute Graft Versus Host Disease
Official title: A Phase I/II, Open-Label, Dose-Escalation, Pilot Study to Evaluate Safety and Preliminary Efficacy of Visilizumab as Primary Therapy for Acute Graft-Versus-Host Disease After Hematopoietic Cell Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Graft vs Host Disease
Lead sponsor: Facet Biotech
Sponsor class: INDUSTRY
First posted: 2002-03-18
Enrollment: 34
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this Phase I/II, open-label, dose-escalation study is to evaluate an investigational monoclonal antibody administered as a first-line therapy to patients with acute, Grade II, III, or IV graft-versus-host disease (GVHD). Patients will be eligible for enrollment within 24 hours of beginning standard steroid treatment. The research is being conducted at up to 10 clinical research sites in the US.

Detailed description: A Phase I/II, open-label, dose-escalation pilot study designed to obtain preliminary safety, pharmacokinetic (PK) and efficacy information on visilizumab administered as a first-line therapy to patients with acute, Grade II, III, or IV graft-versus-host disease (GVHD). It is anticipated that up to 34 patients at up to 10 study centers could be eligible for enrollment in this study. Patients will be eligible for enrollment within 24 hours of beginning standard steroid treatment (2 mg/kg of methylprednisolone IV, or 10 mg/kg hydrocortisone IV, per day). Steroids will be rapidly tapered over one week following visilizumab administration.

Eligibility criteria: * Patients who develop Grade II, III, or IV acute GVHD following allogeneic hematopoietic cell transplantation
* Patients receiving GVHD prophylaxis including cyclosporine or tacrolimus
* Clinical findings: skin thickening, joint contraction, oral ulceration, diarrhea.
* Patients with an onset date of acute GVHD that is less than or equal to 100 days posttransplant.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope National Medical Center
state: California
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center
state: Washington
Study officials:
References:
Clinical trial NCT00644592: LXRA Gene Polymorphisms and Response to Fenofibrate
Official title: LXRA Gene Polymorphisms and Response to Fenofibrate
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Healthy
Keywords: Healthy Volunteers
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: American College of Clinical Pharmacy
First posted: 2008-03-27
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This is a research study of how a cholesterol medication known as fenofibrate works differently in people with different genetic backgrounds. "Genetics" refers to certain things that are passed to a person by their parents, such as eye color or hair color. Genetic differences lead to people having different eye and hair color. There are also genetic differences in a protein called liver X receptor-alpha (LXRA), which may be important in predicting the response to fenofibrate.

Detailed description: This is a double blind crossover study of fenofibrate vs. placebo in healthy volunteers. The null hypothesis is that over a four week period, fenofibrate (160mg/day orally) is equivalent to placebo in terms of relative changes in cytokines ENA-78 and MCP-1 over a four week periods, separated by a four week washout. ENA-78 is a marker of inflammation. See http://en.wikipedia.org/wiki/CXCL5 for more details.

Eligibility criteria: Inclusion Criteria:

* Triglycerides equal to or above 150mg/dL or Low HDL (below 44 mg/dl for men or below 54 mg/dl for women)
* Must be able to swallow tablets

Exclusion Criteria:

* Known Coronary Heart Disease, symptomatic carotid artery disease, abdominal aortic aneurysm, diabetes, or Framingham risk score above 20%
* Pregnancy, malignancy, liver dysfunction, renal dysfunction, active alcohol abuse, history of unexplained muscle pain
* Current treatment with lipid lowering therapy, estrogens, androgens, progestins, thiazide diuretics, beta-blockers, glucocorticoids (other than inhaled), antihistamines, or chronic anti-inflammatory drugs
* Current treatment with the following the interacting drugs: ursodeoxycholic acid, ursodiol, cholestyramine, red yeast rice, glyburide, glipizide, warfarin, or cyclosporine

Primary outcomes:
measure: Log(ENA-Period 2 End/ENA Period 1 End)
timeFrame: week 12 to week 4
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida College of Pharmacy, Center for Pharmacogenomics
state: Florida
Study officials:
affiliation: University of Florida College of Pharmacy, Department of Pharmacy Practice, Center for Pharmacogenomics
name: Issam Zineh, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04346992: Prevalence Of Keratoconus Among Patients With Thyroid Gland Dysfunction
Official title: Prevalence Of Keratoconus Among Patients With Thyroid Gland Dysfunction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Keratoconus in Thyroid Gland Dysfunction
Lead sponsor: Fayoum University
Sponsor class: OTHER
First posted: 2020-04-15
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: we will enroll all patients who meet the inclusion criteria and signed a written informed consent form

Brief summary: Hormonal imbalances are likely to affect the corneal metabolism and may be also associated with Keratoconus. Among the various endocrinologic dysfunctions assumed so far, thyroid gland dysfunction (TGD) (hypo- or hyperthyroidism; comprised as TGD) is frequently associated with eye diseases such as Graves disease

Detailed description: Aim of the work

We aim to examine the prevalence of KC among patients already diagnosed by endocrinologist with TGD.

Materials and methods

Our Screening for KC will include evaluation of the demographic data and complete ophthalmological examination of the patients using:

VA Refraction K reading Slit lamp examination Pentacam Study design Epidemiological study

Inclusion citeria All patients diagnosed as thyroid gland dysfunction Control group

Exclusion criteria Uncooperative patients

Eligibility criteria: Inclusion Criteria:

* All patients diagnosed as thyroid gland dysfunction

Exclusion Criteria:

* Uncooperative patients

Primary outcomes:
measure: prevalence of keratoconus in thyroid gland dysfunction
timeFrame: we will recruit patients who meer the inclusion criteria during the study period April-August 2020
Secondary outcomes:
Other outcomes:
Locations:
city: Fayoum
country: Egypt
facility: Fayoum University
Study officials:
References:
Clinical trial NCT01824992: Recombinant Human Interferon a-2b Gel for HPV Gynecological Infections
Official title: a Multi-sites, Randomized, Parallel, Controlled Clinical Study to Evaluated the Efficacy and Safety of Recombinant Human Interferon Alpha-2b Gel (Yallaferon®) in HPV Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: HPV Infection
Lead sponsor: Lee's Pharmaceutical Limited
Sponsor class: INDUSTRY
First posted: 2013-04-05
Enrollment: 325
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: to assess the efficacy and safety of recombinant human interferon α-2b gel (Yallaferon®) for the treatment of patients with cervical high-risk HPV infections; to analyze the HPV type infections and clinical negative conversion.

285 patients with positive high risk HPV infection were randomized into interferon gel group and control group at ratio of 2:1 (203 patients in treatment group and 82 patients in control group). The patients in treatment group received 1g recombinant human α-2b interferon gel every other day for consecutive 3 courses of treatment, whereas no treatment was conducted in control group.


Eligibility criteria: Inclusion Criteria:

1. Age 30 to 65 years of age the sex life of female patients;
2. , liquid-based cytology (TCT) check no intraepithelial lesions and malignant cells;
3. , HPV DNA typing test for high-risk HPV positive (including a single high-risk type positive, and more high-risk type of positive and high-and low-risk hybrid positive).

15 kinds of high-risk types, including HPV16, 18,31,33,35,39,45,51,52,53,56,58,59,66,68

Exclusion Criteria:

* (1) cervical intraepithelial neoplasia (CIN); (2), combined with a severe fungal, trichomonas vaginitis; (3), severe primary diseases associated with cardiovascular, liver, kidney and hematopoietic system; (4), allergies or allergy to the drug known ingredients. (5), within 30 days to accept other clinical trials of drugs or are participating in clinical trials; (6), pregnant and lactating women and to be pregnant women; (7), the researchers do not consider it appropriate clinical trials.

Primary outcomes:
measure: difference of hr-HPV DNA negative conversion rate
timeFrame: six months
Secondary outcomes:
measure: Secondary efficacy endpoints were the differences of single-type HPV infection, dual infection and multiple infections on the 6th month between the two groups.
timeFrame: six months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01494792: Sofia Strep A FIA Field Study
Official title: Sofia Strep A FIA Field Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Group A Streptococcus
Strep Throat
Lead sponsor: Quidel Corporation
Sponsor class: INDUSTRY
First posted: 2011-12-19
Enrollment: 2090
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects must be three (3) years of age or older and exhibiting symptoms characteristics of pharyngitis, possibly Group A Streptococcus.

Brief summary: The purpose of this study is to demonstrate the ability of the Sofia Strep A FIA test and Sofia Analyzer to accurately detect a throat swab specimen for the presence or absence of Group A Streptococcus when compared to culture.


Eligibility criteria: Inclusion Criteria:

* Presence of sore throat
* Redness of the posterior pharyngeal wall
* Tonsillar exudate
* Tonsillar swelling
* Tender anterior cervical adenopathy
* Fever, \> 38º C (100.4ºF) at presentation or within past 24 hours

Other symptoms that may be present, in addition to above symptoms for GAS:

* Rash, typical of scarlet fever
* Abnormal tympanic membranes
* Palatal petechiae

Exclusion Criteria:

* Subjects treated with antibiotics currently or within the previous week (7 days) are not to be included in this study.
* At clinical sites requiring informed consent, unable to understand and consent to participation; for minors this includes parent or legal guardian.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Carlsbad
country: United States
facility: La Costa Pediatrics
state: California
city: Panorama City
country: United States
facility: Santo Nino Medical Clinic
state: California
city: San Diego
country: United States
facility: La Jolla Pediatrics
state: California
city: Tampa
country: United States
facility: Teena Hughes, MD
state: Florida
city: Chicago
country: United States
facility: Children's Memorial Hospital
state: Illinois
city: Rochester
country: United States
facility: Twelve Corners Pediatrics
state: New York
city: Akron
country: United States
facility: Montrose Family Practice
state: Ohio
city: Vienna
country: United States
facility: Advanced Pediatrics
state: Virginia
Study officials:
References:
Clinical trial NCT00508092: Combined Nerve Blockade and Local Infiltration Anesthesia in Appendectomy - A Blinded Randomized Study
Official title: Combined Nerve Blockade and Local Infiltration Anesthesia in Appendectomy - A Blinded Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Keywords: appendicectomy
pain
local anaesthetic
nerve block
Post operative pain following appendicectomy
Lead sponsor: Royal Berkshire NHS Foundation Trust
Sponsor class: OTHER_GOV
First posted: 2007-07-27
Enrollment: 75
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess whether the use of local anesthetic to numb the nerves that run deeper in the abdominal wall gives better post operative pain control than just infiltrating local anesthetic to the wound edges.

Detailed description: Local anesthetic is often administered during an operation to reduce post operative wound pain. Whilst this is frequently done during an appendectomy there is currently no evidence to suggest whether there is any benefit to the patient to injecting the local anesthetic deeper to block the nerves supplying abdominal wall sensation, compared to using it just in the skin around the wound.

Comparison: Post operative pain scores following appendectomy for patients given skin infiltration of local anesthetic (pre incision), compared to patients given both preincision wound infiltration and deeper field infiltration with local anesthetic(deep to external oblique).

Eligibility criteria: Inclusion Criteria:

* Lanz incision appendectomy as starting procedure, including those where an alternative cause for symptoms is found at operation and those where incision is later extended/changed (these may be sub grouped at time of analysis)
* Consent obtained

Exclusion Criteria:

* Laparoscopic appendectomy
* Appendectomy at time of laparotomy/other incision

Primary outcomes:
measure: Post operative pain score
timeFrame: 1 hour, 4 hours, 8 hours, 24 hours and on discharge
Secondary outcomes:
measure: Post operative nausea and vomiting
timeFrame: 1 hour, 4 hours, 8 hours, 24 hours and on discharge
Other outcomes:
Locations:
city: Reading
country: United Kingdom
facility: Royal Berkshire Hospital
state: Berkshire
Study officials:
affiliation: Royal Berkshire NHS Foundation Trust
name: Jonathan K Randall, MRCS
role: PRINCIPAL_INVESTIGATOR
affiliation: Royal Berkshire NHS Foundation Trust
name: Simon B Middleton, FRCS
role: STUDY_CHAIR
affiliation: Royal Berkshire NHS Foundation Trust
name: Arnold Goede, MRCS
role: STUDY_DIRECTOR
References: