louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01658826: Safety and Efficacy Comparator Trial of a New Drug Against Genital Herpes
Official title: A Double-blind, Double Dummy, Randomized Crossover Trial to Compare the Effect of "AIC316 (Pritelivir)" 100 mg Once Daily Versus Valacyclovir 500 mg Once Daily on Genital HSV Shedding in HSV-2 Seropositive Adults.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Genital Herpes
Keywords: AIC316
Viral shedding
Lead sponsor: AiCuris Anti-infective Cures AG
Sponsor class: INDUSTRY
Collaborators: name: Medpace, Inc.
First posted: 2012-08-07
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The aim of the study is to evaluate the safety and efficacy of "AIC316 (pritelivir)" 100 mg once daily compared to valacyclovir 500 mg once daily for the prevention of HSV-2 genital shedding.

Detailed description: Enrolled patients with Mucocutaneous genital HSV, will be randomized to receive either AIC326 or Valacyclovir first and then will be crossed over to receive the opposite Intervention. The study will consist of two treatment periods of 28 days separated by a washout period of 28 days.

Eligibility criteria: Inclusion Criteria:

* Adult, immunocompetent men and women in good health of any ethnic group
* Seropositive for Herpes Simplex Virus Type 2 (HSV-2)
* History of recurrent episodes (\>=4 to \<=9) of genital herpes for at least 12 months and willingness to obtain 4 swabs per day.

Exclusion Criteria:

* Present episode of genital herpes at time of randomization
* Clinically relevant acute or chronic infections (excluding HSV-2)
* Known intolerance to valacyclovir, acyclovir, or any component of the formulation
* Documented HSV resistance to acyclovir, valacyclovir, famciclovir or penciclovir

Primary outcomes:
measure: Within-subject Genital HSV Mucocutaneous Shedding Rate
timeFrame: 28 days
measure: Overall Shedding Rate
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University School of Medicine, IU Infectious Diseases Research
state: Indiana
city: Portland
country: United States
facility: Westover Heights Clinic
state: Oregon
city: Houston
country: United States
facility: University of Texas Health Science Centre, Center for Clincial Studies
state: Texas
city: Seattle
country: United States
facility: University of Washington, Virology Research Clinic
state: Washington
Study officials:
References:
citation: Wald A, Timmler B, Magaret A, Warren T, Tyring S, Johnston C, Fife K, Selke S, Huang ML, Stobernack HP, Zimmermann H, Corey L, Birkmann A, Ruebsamen-Schaeff H. Effect of Pritelivir Compared With Valacyclovir on Genital HSV-2 Shedding in Patients With Frequent Recurrences: A Randomized Clinical Trial. JAMA. 2016 Dec 20;316(23):2495-2503. doi: 10.1001/jama.2016.18189.
Clinical trial NCT00820326: Efficacy of Dolasetron in Patients With Fibromyalgia
Official title: A Randomized, Double-Blind, Placebo-Controlled, Study of Efficacy of DOLASETRON in Patients With Fibromyalgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Fibromyalgia
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2009-01-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study offers a new treatment, dolasetron or ANZEMET ®, which will be administered by intravenous way once a day during a 4 days Hospitalization.

This study is double blind (neither you nor the physician will know if you are receiving active study drug or placebo).

Randomisation at the beginning of the study will decide whether you receive active treatment or its placebo.

This treatment will be renewed after one month, after 2 months and after 3 months.

If the study staff determines that you are eligible and you decide to participate, there will be approximately 6 study visits in about 9 months. During these visits, you will undergo routine health exams and complete different kinds of questionnaires.

Following this first period of 3 months, you agree to come back for consultation at month 4, month 6 and month 12 for monitoring and evaluating the effects of treatment.


Eligibility criteria: Inclusion Criteria:

* Patients aged 18 to 75
* Primitive Fibromyalgia according to ACR criteria
* Patient no responding to conventional treatment
* Women of childbearing age using an efficace contraception
* Signed consent

Exclusion Criteria:

* Inflammatory rheumatic diseases
* Diseases of the system: Gougerot Sjögren, polymyositis, vasculitis,
* Infectious diseases: hepatitis B and C, lyme disease, HIV,
* Hypothyroidism,
* Bone and mineral metabolism disorders
* Disorders of cardiac conduction
* Failure of Heart, of kidney or liver,
* Patient allergic to dolasetron
* Pregnant or nursing women
* Women without means of contraception,
* Age \<18 or \> 75 years.

Primary outcomes:
measure: Measure: Improving visual analogue scale (VAS) between Inclusion visit and month 3
timeFrame: Inclusion visit and month 3
Secondary outcomes:
measure: Improving visual analogue scale (VAS)
timeFrame: Between Inclusion visit, month 1, month 2, month 4, month 6, and month 12.
measure: Fibromyalgia impact questionnaire SF-36 scale and Beck depression scale
timeFrame: Between Inclusion visit, month 1, month 2, month 4, month 6, and month 12.
measure: Anxiety index
timeFrame: Between Inclusion visit, month 1, month 2, month 4, month 6, and month 12.
measure: Number of painful trigger points
timeFrame: Between Inclusion visit, month 1, month 2, month 4, month 6, and month 12.
Other outcomes:
Locations:
city: Limoges
country: France
facility: Service de Rhumatologie, CHu de Limoges
Study officials:
References:
Clinical trial NCT03802526: Pharmacokinetic Interaction and Safety/Tolerability Between NVP-1805-R1 and NVP-1805-R2
Official title: Pharmacokinetic Interaction and Safety/Tolerability Between NVP-1805-R1 and NVP-1805-R2 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: NVP Healthcare
Sponsor class: INDUSTRY
First posted: 2019-01-14
Enrollment: 37
Sex: ALL
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the pharmacokinetics and safety/tolerability between NVP-1805-R1 and NVP-1805-R2

Detailed description: pharmacokinetics and safety/tolerability between NVP-1805-R1 and NVP-1805-R2

Eligibility criteria: Inclusion Criteria:

* Male or female adults aged 19-45 years.
* BMI of \>18.5 kg/㎡ and \<27.0 kg/㎡ subject, weight more than 50kg.
* Voluntarily provided a witten consent to participate in this clinical study.

Exclusion Criteria:

* Treatment with an investigational product (Phase I study or Biological study) within 3month preceeding the first dose of study medication.
* History of (or presence) study medication absortion, distribution, metabolism(e.g., liver/ductal, kidney, cardio-vascular, endocrine, respiratory, GI, hematology, oncology, CNS, musculo-skeletal) or related past medical/surgery history
* Pregnant or lactating women.

Primary outcomes:
measure: Pharmacokinetic interaction
timeFrame: 0hours - 48hours
Secondary outcomes:
Other outcomes:
Locations:
city: Suwon-si
country: Korea, Republic of
facility: Navipharm
state: Gyeonggi-do
Study officials:
affiliation: Gachon University Gil Medical Center
name: Dong Sung Shin, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim CH, Kang SI, Shin D. Pharmacokinetic Interaction Between Telmisartan and Rosuvastatin/Ezetimibe After Multiple Oral Administration in Healthy Subjects. Adv Ther. 2021 Feb;38(2):1094-1105. doi: 10.1007/s12325-020-01592-8. Epub 2020 Dec 16.
Clinical trial NCT05673226: Organosilane for Surface Cleaning in Intensive Care Units
Official title: Organosilane for Surface Cleaning in Intensive Care Units: A Cluster Randomized, Controlled, Crossover, Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Infection, Hospital
Keywords: Infection Control
Infections
Intensive Care Units
Pneumonia, Ventilator Associated
Catheter-Related Infections
Urinary Tract Infections
Organosilanes
Costs and Cost Analyses
Lead sponsor: Hospital Israelita Albert Einstein
Sponsor class: OTHER
Collaborators: name: Hospital Sirio-Libanes
name: Hospital Moinhos de Vento
name: Hospital Alemão Oswaldo Cruz
name: Hospital do Coracao
name: Beneficência Portuguesa de São Paulo
First posted: 2023-01-06
Enrollment: 13000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized, controlled, cluster, crossover, trial
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate if surface disinfection with organosilane associated with traditional cleaning reduces the incidence of healthcare-associated infections (HAIs) in intensive care units when compared with traditional cleaning alone.


Eligibility criteria: Inclusion Criteria:

* All patients aged 18 years and older who will be admitted to the participating ICUs

Exclusion Criteria:

* Patients under 18 years
* ICUs that may use any organosilane formulation for surface disinfection

Primary outcomes:
measure: Incidence of healthcare associated infections
timeFrame: 6 months
Secondary outcomes:
measure: Contamination of environmental surfaces by multi-resistant microorganisms
timeFrame: 6 months
measure: Incidence of ventilator-associated pneumonia
timeFrame: 6 months
measure: Incidence of central line-associated blood stream infections
timeFrame: 6 months
measure: Incidence of catheter-associated urinary tract infection
timeFrame: 6 months
measure: Intensive care unit length of stay costs
timeFrame: 6 months
Other outcomes:
Locations:
city: Belo Horizonte
country: Brazil
facility: Santa Casa de Misericórdia
city: Belém
country: Brazil
facility: Hospital Jean Bittar
city: Brasília
country: Brazil
facility: Hospital de Base do Distrito Federal
city: Brasília
country: Brazil
facility: Hospital Universitário de Brasília
city: Fortaleza
country: Brazil
facility: Hospital Otoclínica
city: Goiânia
country: Brazil
facility: Hospital Geral de Goiânia
city: Olinda
country: Brazil
facility: Hospital do Tricentenário
city: Pelotas
country: Brazil
facility: Hospital Escola Universidade Federal de Pelotas
city: Porto Alegre
country: Brazil
facility: Hospital Ernesto Dornelles
city: Salvador
country: Brazil
facility: Hospital Ana Nery
city: Santa Cruz Do Sul
country: Brazil
facility: Hospital Santa Cruz
city: São Luís
country: Brazil
facility: Hospital Presidente Vargas
city: São Paulo
country: Brazil
facility: A.C. Camargo Cancer Center
city: São Paulo
country: Brazil
facility: Hospital do Coração
Study officials:
References:
Clinical trial NCT00743626: Pap Smear Research Study
Official title: Evaluation of the Role of Human Papillomavirus Testing and p16 Expression in the Management of Patients Undergoing Cervical Cancer Screening
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Cancer
Keywords: Pap test
HPV
Healthy patients screened for cervical cancer tests.
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2008-08-29
Enrollment: 1712
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The principal hypothesis of this study is that HPV testing and/or p16 testing, either alone or in combination or associated with a Pap smear, will demonstrate greater specificity for clinically significant precancerous disease than will a Pap smear alone and that these tests will be of comparable or superior sensitivity than the Pap smear.


Eligibility criteria: Inclusion Criteria:

* 18 years and older
* Ability to speak and clearly understand English
* Female patients

Exclusion Criteria:

* No previous history of Cervical Cancer Treatment(LEEP,Laser,Cone etc.)
* Women who have had Pap smears within the previous 10 months
* Women under the age of 18.
* Women who are pregnant.
* Inability to give informed consent in English

Primary outcomes:
measure: To provide cervical cancer screening (Pap smear, HPV test and/or p16 tests) to determine whether further intervention (colposcopy) is required
timeFrame: 1st visit, 12 months, 18 months follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network - Toronto Western Hospital
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Joan K Murphy, MD,FRCSC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01599026: Cardiac Septal Hypertrophy in the Fetus of Diabetic Mother and Its Effect on Postnatal Cardiac Function
Official title: Cardiac Septal Hypertrophy in the Fetus of Diabetic Mother and Its Effect on Postnatal Cardiac Function
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiology in Fetus of Diabetic Mother
Keywords: cardiology
fetus of diabetic mother
Lead sponsor: Ain Shams Maternity Hospital
Sponsor class: OTHER
First posted: 2012-05-15
Enrollment: 120
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: diabetic pregnant ladies gestational age more than 35 weeks

Brief summary: Good glycemic control is superior to poor glycemic control in reducing risk of interventricular septum thickness among fetuses of diabetic mothers

Detailed description: Good glycemic control is superior to poor glycemic control in reducing risk of interventricular septum thickness among fetuses of diabetic mothers specially during third trimester of pregnancy

Eligibility criteria: Inclusion Criteria:

* singleton pregnancy
* gestational age 36 weeks

Exclusion Criteria:

* congenital anomalies
* obstetric complications
* medical disorders other than diabetes

Primary outcomes:
measure: To study interventricular septum thickness in fetus of diabetic mother and correlate it with good glycemic control.
timeFrame: one year
Secondary outcomes:
measure: cardiac function in infant of diabetic mother
timeFrame: one year
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: AinShamsMH
Study officials:
References:
Clinical trial NCT00633126: Pharmacokinetics of Ceftaroline in Subjects 12 to 17 Years of Age
Official title: Pharmacokinetics of a Single Dose of Ceftaroline in Subjects 12 to 17 Years of Age Receiving Antibiotic Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Infection
Keywords: PK
Pharmacokinetics
Lead sponsor: Forest Laboratories
Sponsor class: INDUSTRY
First posted: 2008-03-11
Enrollment: 9
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is to determine the pharmacokinetics of ceftaroline in pediatric subjects

Detailed description: The purpose of this study is to determine the pharmacokinetics profile of ceftaroline in pediatric subjects

Eligibility criteria: Inclusion Criteria:

* Hospitalized and receiving antibiotic therapy for treatment of a suspected infection of any type
* Body mass index (weight \[kg\]/height squared \[m2\]) of no more than 30
* Males and females between 12 and 17 years of age, inclusive

Exclusion Criteria:

* History of any hypersensitivity or allergic reaction to any β-lactam antimicrobial
* Past or current history of epilepsy or seizure disorder
* Critically ill or unstable patients

Primary outcomes:
measure: The Maximum Plasma Concentration (Cmax) of Ceftaroline After Administration of Ceftaroline Fosamil at a Dose of 8 mg/kg up to a Maximum Dose of 600 mg Via IV Infusion Over 60 Minutes.
timeFrame: 12 hours after infusion
Secondary outcomes:
measure: Number of Adverse Events (AEs) Reported After Starting Study Drug Administration (Treatment Emergent Adverse Events, TEAEs) by Relationship to Ceftaroline (Related or Unrelated).
timeFrame: Signing of Informed Consent Form (ICF) to last follow up (FU) visit, study day 7 (+-2 days).
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Investigational Site
state: Kentucky
city: Durham
country: United States
facility: Investigational Site
state: North Carolina
city: Akron
country: United States
facility: Investigational site
state: Ohio
city: Cleveland
country: United States
facility: Invetigational Site
state: Ohio
Study officials:
affiliation: Forest Laboratories
name: Medical Monitor Cerexa
role: STUDY_DIRECTOR
References:
Clinical trial NCT05853926: Spinal Manipulation With Laser Therapy Versus Dry Needling in Chronic Lower Backache
Official title: Spinal Manipulation With Laser Therapy Versus Dry Needling in Chronic Lower Backache: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Low Back Pain
Lead sponsor: Superior University
Sponsor class: OTHER
First posted: 2023-05-11
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: To determine the effectiveness of spinal manipulation with laser therapy versus dry needling for pain, disability and fear of movement in chronic low backache


Eligibility criteria: Inclusion Criteria:

* Those patients will be included in the study who have chronic low back pain (12 week duration).

both genders aged 18-60 years low back pain

Exclusion Criteria:

* Those patients will be excluded in the study who have needle phobia, any infection, cancer, dermal changings, heart transplant, pregnancy, rheumatic fever(25)fracture, cauda equina syndrome, arrhythmia, sensory deficiency, mental illness, surgery, osteoporosis, low term use of steroid

Primary outcomes:
measure: Oswestry Disability Index scale
timeFrame: 6 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Chaudary Muhammad Akram Teaching Hospital
state: Punjab
Study officials:
References:
Clinical trial NCT00516126: Goal-orientated Therapy of Perioperative Disturbance in Hemostasis in Cardiac Surgery
Official title: Goal-orientated Therapy of Perioperative Disturbance in Hemostasis With MULTIPLATE and ROTEM in Cardiac Surgery Patients Under Platelets Inhibitors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Bypass Graft Triple Vessel
Blood Coagulation Disorders
Keywords: hemostasis monitoring
perioperative blood loss
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2007-08-14
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing cardiac surgery

Brief summary: Aim of this study is to investigate whether patients preoperatively treated with acetylsalicylic acid and/or clopidogrel have fewer perioperative bleeding and lower amounts of blood substitution when managed by ROTEM (whole blood coagulation analyzer) and MULTIPLATE (thrombocyte function analyzer).


Eligibility criteria: Inclusion Criteria:

* written consent

Exclusion Criteria:

* no written consent

Primary outcomes:
measure: Perioperative blood loss
timeFrame: 24 hours
Secondary outcomes:
measure: perioperative substitution with erythrocyte concentrates, thrombocyte concentrates or fresh frozen plasma
timeFrame: 24 hours and 7 days
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel
state: CH
Study officials:
affiliation: Department of Anesthesia, University Hospital Basel, CH-4031 Basel, Switzerland
name: Miodrag Filipovic, PhD, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00795626: Impact of Systematic Nursing Orientations in the Reduction of Predicted Cardiovascular Risk in Patients With Coronary Artery Disease.
Official title: Impact of Systematic Nursing Orientations in the Reduction of Predicted Cardiovascular Risk in Patients With Coronary Artery Disease.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Heart Disease
Keywords: nursing education
cardiovascular risk factors
coronary heart disease
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2008-11-21
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Evaluate the impact of systematic nursing orientations in the reduction of predicted cardiovascular risk in patients with coronary artery disease during four nursing visits for a 1-year period and compare to a group of patients submitted to conventional treatment.

Detailed description: Assess 184 (two groups) patients during four nursing visits for a 1-year period and compare to a group of patients submitted to conventional treatment. We will evaluate the impact of systematic nursing orientations in the reduction of predicted cardiovascular risk in patients with coronary artery disease.

Eligibility criteria: Inclusion Criteria:

* patients of both sexes;
* aged 18 years or older;
* diagnosed with ACS (unstable angina and acute myocardial infarction with ST segment elevation and without ST segment elevation) with CAD diagnosed by cardiac catheterization or electrocardiogram;
* patients have to agree to participate by signing a consent term

Exclusion Criteria:

* patients with cognitive deficits;
* neurological sequelae;
* who are not able to come for visits, or who do not consent to participate in the study.

Primary outcomes:
measure: Reduction of Predicted Cardiovascular Risk
timeFrame: one year
Secondary outcomes:
measure: Knowledge of the risk factors and the adhesion to pharmacology treatment; Reduction of the modified risk factors in the previous knowledge of patients and their adhesion;
timeFrame: one year
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Eneida Rejane Rabelo
state: Rio Grande do Sul
Study officials:
affiliation: Federal University of Rio Grande do Sul Post Grad Prog
name: Eneida R Rabelo, RN, ScD
role: PRINCIPAL_INVESTIGATOR
References: