louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02945163: Dosing of Tenofovir and Efavirenz in Antiretroviral Therapy
Official title: The Optimization of HAART for Chinese--a RCT Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV Infections
Lead sponsor: Shanghai Public Health Clinical Center
Sponsor class: OTHER_GOV
Collaborators: name: The Second Hospital of Nanjing Medical University
name: Yunnan Provincial Infectious Disease Hospital
First posted: 2016-10-26
Enrollment: 184
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Tenofovir+lamivudine+efavirenz is still the first line regimen of combination antiretroviral therapy in developing countries. Based on our previous data, we aim to evaluate whether reduce the dose of tenofovir and efavirenz could decreasing the incidence of the side effects while not scarifying their virological efficacy.


Eligibility criteria: Inclusion Criteria:

* HIV antibody positive
* Chinese nationality
* Naïve to antiretroviral therapy
* Willing to start antiretroviral therapy
* Provision of written informed consent

Exclusion Criteria:

* Pregnant, breastfeeding, or lactating
* Females try to get pregnant during the research period
* Subjects who allergic to any of the research drugs
* Subjects that taking other drugs that known to impact the absorption, distribution, metabolism and excretion of the research drugs
* Any serious or active medical or psychiatric illness which, in the opinion of the Investigator, would interfere with treatment, assessment, compliance with the protocol, or subject safety. This would include any active clinically significant renal, cardiac, pulmonary, vascular, or metabolic (thyroid disorders, adrenal disease) illness, or malignancy
* Medical or psychiatric condition or occupational responsibilities that may preclude compliance with the protocol
* Laboratory blood values:
* Haemoglobin \<9.0 grams/decilitre (g/dL)
* Neutrophil count \<1500/mm3
* Platelet count \<75,000/mm3
* Aspartate aminotransferase or Alanine transaminase \>3 times Upper Limit of Normal (ULN)
* Total bilirubin \>3 times Upper Limit of Normal (ULN)
* Subjects with an estimated creatinine clearance of \<90 mL/minute

Primary outcomes:
measure: Percentage of patients with HIV RNA<50 Copies/ml
timeFrame: 48 weeks
Secondary outcomes:
measure: Adverse events
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The Second Hospital of Nanjing
state: Jiangsu
city: Shanghai
country: China
facility: Shanghai Public Health Clinical Center
state: Shanghai
city: Kunming
country: China
facility: Yunnan provincial infectious disease hosipital
state: Yunnan
Study officials:
References:
Clinical trial NCT00141063: Safety and Efficacy Study of Dexmethylphenidate in Children With ADHD
Official title: Safety and Efficacy Study of Dexmethylphenidate in Children With ADHD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: ADHD
Keywords: ADHD, children
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-01
Enrollment: 90
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the safety and efficacy of two doses of dexmethylphenidate to two doses of an approved, long-acting, marketed medication for ADHD (MPH) and placebo in children ages 6-12 diagnosed with ADHD.


Eligibility criteria: Inclusion Criteria:

* DSM-IV diagnosis of ADHD
* Males and females aged 6-12

Exclusion Criteria:

* Inability of understand or follow instructions
* Is pregnant
* Diagnosis of tic disorder
* History of seizure disorder

Primary outcomes:
measure: Change in attention and deportment measured at 2 hours post-dose
Secondary outcomes:
measure: Onset of effect at 0.5, 1, 2, 3, 4, 6, 8, 10, 11, and 12 hours post-dose
measure: Parent's assessment of patient behavior across all treatment periods as measured by the change from baseline
measure: Safety and tolerability of two doses of dexmethylphenidate compared to two doses of an approved, long-acting, marketed medication for ADHD and placebo in children ages 6-12 diagnosed with ADHD.
Other outcomes:
Locations:
city: Las Vegas
country: United States
facility: Center for Psychiatry & Behavioral Medicine
state: Nevada
Study officials:
affiliation: Center for Psychiatry and Behavioral Medicine
name: Ann Childress, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01542463: Evaluation of the Use of Levemir® in Insufficiently Controlled Patients With Type 1 or Type 2 Diabetes
Official title: Levemir®: the Physiological Basal Insulin. Documentation of Safety Aspects, Glycaemic Control and Weight
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-03-02
Enrollment: 4464
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with insufficiently controlled type 1 or type 2 diabetes mellitus under their previous therapy

Brief summary: This study conducted in Europe. The aim of this study is to evaluated the use of insulin detemir (Levemir®) in insufficiently controlled patients with type 1 or type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* Patients with insufficiently controlled type 1 or type 2 diabetes mellitus under their previous therapy

Primary outcomes:
measure: HbA1c (glycaemic haemoglobin)
measure: Fasting plasma glucose (FBG)
Secondary outcomes:
measure: Body weight change
measure: Adverse drug reactions (ADR)
measure: Serious adverse drug reactions (SADR)
measure: Hypoglycaemic episodes
Other outcomes:
Locations:
city: Mainz
country: Germany
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT06730763: Effect of Transcranial Direct Current Stimulation on Risk of Falling in Cerebral Palsy Spastic Hemiplegic Children
Official title: Effect of Transcranial Direct Current Stimulation on Risk of Falling in Cerebral Palsy Spastic Hemiplegic Children
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cerebral Palsy (CP)
Keywords: cerebral palsy
spastic hemiplegia
risk of falling
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-12-12
Enrollment: 30
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to determine:

* If there is an effect of transcranial direct current stimulation in improvement the functional balance in CP spastic hemiplegic children.
* If there are any changes in risk of falling in CP spastic hemiplegic children or not.

Detailed description: With the decline of mobility comes a drastic increase in falling. However, people of all ages with cerebral palsy can fall easily due to imbalance issues and non-voluntary movements. Individuals with cerebral palsy (CP) can experience a variety of sensorimotor impairments that impact balance, making excessive tripping and falling among the most common concerns for ambulatory individuals with CP. Approximately 53-97% of ambulatory individuals fall at least once per year, causing injury, embarrassment, frustration, activity avoidance, and isolation. Although a study of over 1000 children found fall frequency was highest in gross motor function classification system (GMFCS) level II, research has not explored if this holds across the decades of adulthood.

Eligibility criteria: Inclusion Criteria:

* Age range between 8-12 years old.
* Classified on levels II and III of the Gross Motor Function Classification System (GMFCS) (Palisiano et al.,1997).
* the ability to walk without the assistance of another individual for at least 12 months prior to the onset of the study, regardless of whether a gait-assistance device was needed (GMFCS level III) or not (GMFCS level II).
* (Pediatric Balance Scale, Timed Up and Go Test 'TUGT') and acceptance of the TDCS procedure.
* Ability to understand and follow simple instructions.
* Parent or guardian consent obtained

Exclusion Criteria:

* Orthopedic deformities, a history of surgery or neurolytic block in the previous 12 months,
* Diagnosis of epilepsy or having experienced convulsive crises (whether treated with medication or not) in at least the two years prior to the onset of the study, metal implants in the skull, or the use of hearing aids.
* Previous participation in a tDCS study within the past 6 months.

Primary outcomes:
measure: The Fall Risk test
timeFrame: From enrollment to the end of treatment at 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Cairo University
Study officials:
References:
Clinical trial NCT00726063: A Prospective Study Evaluating the Performance of Nanotite Osseotite Implants When Placed by Graduate Student Programs
Official title: A Prospective Randomized-controlled Evaluation of Nanotite and Osseotite Surfaced Implant Performance in Graduate Student Programs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tooth Disease
Partial Edentulism
Keywords: dental implants
Nanotite implant
Osseotite implants
multicenter
randomized
clinical study
partial edentulism
prosthesis
Lead sponsor: ZimVie
Sponsor class: INDUSTRY
First posted: 2008-07-31
Enrollment: 241
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: implant types were randomized- 2 different surface treatments
Primary purpose: TREATMENT

Brief summary: This study will evaluate the contributions of the Nanotite implant design when used by graduate students in their first year of placing implants.

Detailed description: This multicenter, prospective, randomized-controlled study will compare the performance of the Nanotite vs. the standard Ossotite implants when placed by graduate students with little or no prior experience. Enrolled patients will have the study site(s) randomized to either a Nanotite (test) or an Osseotite (control) implant. The manner of treatment observed at the participating center will be followed for this study.

Study Hypothesis: The performance of the Nanotite implant in this study will be no different than or superior to that of the Osseotite implant placed during the early period of graduate student training.

Eligibility criteria: Inclusion Criteria:

* patients of either sex and of any race, 18 years of age or older
* patients for whom a decision has already been made to use dental implants for treating edentulism in the mandible or maxilla

Exclusion Criteria:

* patients who are known to be pregnant

Primary outcomes:
measure: Integration Success of the Implant
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Michael S Reddy, DMD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01352663: Immunogenicity Safety Study of Wockhardt's Recombinant Insulin Analogue in Type 1 Diabetic Patients
Official title: An Open Label, Randomized Comparison of Wockhardt's Recombinant Insulin Analogue With Innovator's Glargine in Type 1 Diabetic Patients.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Type I Diabetes
Keywords: Type I Diabetes
Wockhardt
Insulin Analogue
Lead sponsor: Wockhardt
Sponsor class: INDUSTRY
First posted: 2011-05-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is an open label, randomized, parallel group comparison of the immunogenicity safety of Wockhardt's Recombinant Insulin Analogue with the innovator's Glargine in Type 1 diabetics patients.

Detailed description: To evaluate and compare the Immunogenicity Safety of Wockhardt's Recombinant Insulin Analogue with innovator's Glargine.

Eligibility criteria: Inclusion Criteria:

1. Patients who have been pre-diagnosed as cases of type-1 diabetes for a period not less than 1 year
2. Male or Female Patients \>= 18 and =\< 55 years of age.
3. Patients with BMI of 18.0 to 30.0 kg/m2
4. Patients who are cooperative, reliable, and agree to have regular injections of insulin and are willing to comply with protocol procedures.

Exclusion Criteria:

1. A Patient who is pregnant or is currently breast-feeding.
2. A Patient with history of severe hypoglycemia within the past year
3. A Patient who is an employee of the Investigator, or a patient who has a direct involvement with the trial or other trials under the direction of the Investigator.
4. Patients who are Hepatitis B or C positive on testing or have positive medical history of HIV at screening.
5. Patients unlikely to comply with the study protocol e.g. unable to return periodically for subsequent visits.

Primary outcomes:
measure: Change in HbAlc from baseline till the end of treatment period.
timeFrame: 12 months
Secondary outcomes:
measure: Percentage change in immunogenic response.
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Wockhardt
name: Dr Ashima Bhatia, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT06451263: Nudge to Gynecologic Oncology
Official title: Nudge to Referral of Adnexal Masses to Gynecologic Oncology
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Ovarian Cancer
Fallopian Tube Cancer
Peritoneal Cancer
Keywords: abnormal adnexal mass
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2024-06-11
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Ovarian cancer lacks an effective screening test, and prompt treatment at diagnosis is the only way to improve outcomes. Referral to gynecologic oncology at diagnosis of adnexal mass is recommend by guidelines from every major medical organization. Yet, 1 in 4 patients with ovarian cancer nationwide and at Penn Medicine never see a gynecologic oncologist. Even when referred to gynecologic oncology, patients from historically-marginalized groups have twice as long duration from diagnosis to seeing gynecologic oncology. In this project, the investigators will pilot a clinician nudge to gynecologic oncology referral and compare the impact to historical controls.

Detailed description: The study consists of one intervention, a clinician nudge to gynecologic oncology referral. Referral to gynecologic oncology is recommended when patients are diagnosed with a complex adnexal mass on imaging (i.e., Ovarian-Adnexal Reporting and Data System \[O-RADS\] 4 or 5 on ultrasound or Magnetic Resonance Imaging \[MRI\]). When patients are identified as having a complex adnexal mass, the order will be pended by the clinical research coordinator and sent to the ordering provider with a message to sign. The message will include content about national guidelines on referral to gynecologic oncology with opt-out framed language.

Eligibility criteria: Inclusion Criteria:

* Women ages 18 years or older
* Adnexal mass identified on imaging (i.e., O-RADS 4 or 5 on ultrasound or MRI, Codex 4 or 5 on CT scan) ordered by Penn Medicine clinician

Exclusion Criteria:

* Known diagnosis of ovarian cancer
* Patient already established in gynecologic oncology

Primary outcomes:
measure: Adoption
timeFrame: 30 days
Secondary outcomes:
measure: Gyn Onc Visits
timeFrame: 90 days
measure: Gyn Onc Visits
timeFrame: 90 days
measure: Adherence to Treatment
timeFrame: 365 days
measure: Progression Free and Overall Survival
timeFrame: 365 days
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
References:
Clinical trial NCT01699763: Evaluation of Blood Glucose Monitoring Systems
Official title: Evaluation of Blood Glucose Meter Systems - Contour® NEXT LINK Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Lead sponsor: Ascensia Diabetes Care
Sponsor class: INDUSTRY
First posted: 2012-10-04
Enrollment: 112
Sex: ALL
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 purpose of this study was to evaluate the performance of a Bayer Blood Glucose Monitoring System (BGMS) and two additional Blood Glucose Monitoring Systems (BGMS) from other companies. All meter BG results were compared with plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).

Detailed description: The purpose of this study was to evaluate the performance of a Bayer Blood Glucose Monitoring System (BGMS) and two additional Blood Glucose Monitoring Systems (BGMS) from other companies. All meter BG results were compared with plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer). Performance of the three systems was evaluated across the glucose range of the BGMSs using capillary blood. All testing and lancing was performed by study staff and some samples were tested from subject fingertips. Additionally, some blood samples were glycolyzed to lower the glucose concentration levels and glucose solution was added to other samples to raise glucose concentration levels.

Eligibility criteria: Inclusion Criteria:

* Males and females, 18 years of age or older
* Willing to complete all study procedures

Exclusion Criteria:

* Blood Borne infections like hepatitis or HIV or infections such as tuberculosis
* Hemophilia or any other bleeding disorder
* Pregnancy

Primary outcomes:
measure: MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) Across the Overall Tested Glucose Range
timeFrame: 8 hours
Secondary outcomes:
measure: MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) in the Low Glucose Range (<=80 mg/dL)
timeFrame: 8 hours
measure: MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) in the High Glucose Range (>180 mg/dL)
timeFrame: 8 hours
Other outcomes:
Locations:
city: Mishawaka
country: United States
facility: Bayer HealthCare LLC, Diabetes Care
state: Indiana
Study officials:
affiliation: Ascensia Diabetes Care
name: David Simmons, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03950063: Cutibacterium Acnes in Bone and Joint Infections
Official title: Cutibacterium Acnes in Bone and Joint Infections
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prosthesis and Bone Infections
Cutibacterium Acnes
Keywords: Cutibacterium acnes Prosthesis
Bone Infections
Lead sponsor: CHU de Reims
Sponsor class: OTHER
First posted: 2019-05-15
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Cutibacterium acnes bone infections

Brief summary: Prosthetic Joint Infections (PJIs) are increasing with the use of orthopedic devices on an ageing population. Cutibacterium acnes is a commensal organism that plays an important role in the ecosystem healthy human skin, yet this species is also recognized as a pathogen in foreign body infection: endocarditis, prostatitis and specifically in PJIs. C. acnes is able to escape the immune system. This phenomenon could reflect two bacterial behavior: the bacterial internalization by host cells and the biofilm formation.

Detailed description: The aim of the study is to evaluate specific pathogenicity factors (ability to internalize bone cells and ability to form a biofilm) of bacteria derived from clinical strains of C. acnes isolated from bone infections on orthopedic material.

Eligibility criteria: Inclusion Criteria:

* bone infection with C. acnes,
* isolation of the strain,
* presence of a single species,
* conservation of a viable strain,
* patients over 18 years

Primary outcomes:
measure: Internalization capacity of C. acnes strains
timeFrame: Day 0
measure: Biofilm capacity of C. acnes strains
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Reims
country: France
facility: Damien JOLLY
Study officials:
References:
Clinical trial NCT03813563: Lactated Ringer's and PlasmaLyte in Critically Ill Adults
Official title: Lactated Ringer's and PlasmaLyte in Critically Ill Adults
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Critical Illness
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2019-01-23
Enrollment: 12000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All ICU admissions

Brief summary: In recent years, there has been a large amount of literature reports that normal saline can increase the incidence of renal injury in critically ill patients compared with balanced salt solution.However, no studies have compared the effects of different types of balanced salt solutions on the incidence of renal injury.


Eligibility criteria: Inclusion Criteria:

* All patients admitted to ICU

Exclusion Criteria:

* Patients \<18 year old when admission
* Patients who stay less than 24 hours in ICU
* Patients who do not sufficient data for further analysis
* Readmission patients during the study period

Primary outcomes:
measure: The incidence of acute kidney injury
timeFrame: from admission to 28 days
Secondary outcomes:
measure: the incidency of CRRT events
timeFrame: from admission to 28 days
measure: the ventilation free days
timeFrame: from admission to 28 days
measure: the vasopressure free days
timeFrame: from admission to 28 days
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Department of Critical care medicine of West China Hospital
state: Sichuan
Study officials:
References: