louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01283503: A Study of BKM120 in Adult Japanese Patients With Advanced Solid Tumors
Official title: A Phase I Study of BKM120, Administered Orally in Adult Japanese Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Solid Tumor
Keywords: PI3K,
Advanced solid tumor
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2011-01-26
Enrollment: 15
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In this study, BKM120 will be administered to adult patients with advanced solid tumors whose disease has progressed despite standard therapy or for whom no standard therapy exists. The trial will confirm the safety and tolerability and determine the maximum tolerated dose (MTD) of BKM120 in Japanese patients.


Eligibility criteria: Inclusion Criteria:

1. Patients with histologically confirmed, advanced unresectable solid tumors who have progressed on (or not been able to tolerate) standard therapy or for whom no standard anticancer therapy exists.
2. At least one measurable or non-measurable lesion as defined by RECIST guidelines for solid tumors.
3. Age ≥ 20 years
4. Eastern Cooperative Oncology Group Performance Status (ECOG P.S.) of ≤ 2
5. Life expectancy of ≥ 12 weeks
6. Patients must have the laboratory values

Exclusion Criteria:

1. Patients with a history of primary central nervous system tumors or brain metastases or who have signs/symptoms attribute to brain metastases and have not been assessed with radiologic imaging to rule out the presence of brain metastases
2. Prior treatment with a PI3K inhibitor
3. Patients with any peripheral neuropathy ≥ CTCAE grade 2
4. Patients with unresolved diarrhea ≥ CTCAE grade 2
5. Women of child-bearing potential who are pregnant or breast feeding. Men or women of reproductive potential not to sign informed consent for birth control. Barrier contraceptives must be used throughout the trial and six months after the end of treatment.

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: establish Maximum tolerate dose (MTD)
timeFrame: every day up to first 4 weeks
Secondary outcomes:
measure: Safety assessed by type, frequency and severity of adverse events
timeFrame: Every week
measure: Efficacy assessed by RECIST
timeFrame: Every 2 months
measure: Establishment of a pharmacokinetic profile by collecting information on parameters including but not limited to Cmax, Tmax, T1/2 and AUC in plasma samples
timeFrame: Every 2 weeks up to first 4 weeks, then every odd cycle
measure: Measurement of biomarkers for PI3K pathway in blood and tissue
timeFrame: First 4 weeks
Other outcomes:
Locations:
city: Nagoya-city
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Kashiwa
country: Japan
facility: Novartis Investigative Site
state: Chiba
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT03901703: The Effects of Functional Strengthening in Spastic Cerebral Palsy
Official title: The Effects of Progressive Functional Ankle Strengthening in Children With Unilateral and Bilateral Spastic Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spastic Cerebral Palsy
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2019-04-03
Enrollment: 27
Sex: ALL
Minimum age (years): 5
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Functional strengthening exercises have been proven to be effective in patients with spastic cerebral palsy. However, which exercise is the most effective is unknown. The aim of this study is to examine the effectiveness of three different progressive functional exercise programs in children with unilateral and bilateral spastic cerebral palsy.

Detailed description: Children with Cerebral Palsy have weakness in thier muscles due to cortical lesions leading to deficiencies in motor control, balance and functional abilities. All children with Cerebral Palsy have shown to present with foot and ankle disorders; the ankle dorsi and plantar flexor muscles are both problematic; the plantarflexors are usually spastic and the dorsiflexors are usually not active enough and usually these muscle problems lead to problems in the childrens' gait abilities. When rehabilitation programs are examined, the results of exercises addressing these problems do not have precise answers. Functional strengthening exercises have been proven to be effective in patients with spastic cerebral palsy. However, which exercise is the most effective is unknown. Which muscle goup has the most effect on gait, balance and functional activities is still unclear. Therefore, the investigator's aim in planning this study is to examine the effectiveness of three progressive functional exercise programs in children with unilateral and bilateral spastic cerebral palsy.

Eligibility criteria: Inclusion Criteria:

* Accepting to participate in the study,
* Being between 5-15 years old,
* Having a diagnosis of Spastic Cerebral Palsy,
* Being level I-II according to GMFCS,

Exclusion Criteria:

* Having limited cooperation which prevents participation in the study,
* Refusing to participate in the study,
* Having an orthopedic disorder or systemic illness which prevents movement in the lower extremities,
* Having a Botulinum toxin application in the last 3 months

Primary outcomes:
measure: Pediatric Balance scale
timeFrame: Change of The Pediatric balance scale at 6 weeks.
measure: Surface Electromyography (sEMG)
timeFrame: Change of sEMG data at 6 weeks.
measure: The Six minute walk test
timeFrame: Change of 6 MWT at 6 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University
Study officials:
affiliation: Gazi University
name: Bulent Elbasan, Assoc. Prof.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01979003: Efficacy of Fluorescein Visualization of the Uterus in Detecting Endometrial Cancer Invasion
Official title: A Pilot Study to Determine the Efficacy of Fluorescein Visualization of the Uterus in Detecting Endometrial Cancer Invasion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Endometrial Cancer
Lead sponsor: University of Arkansas
Sponsor class: OTHER
First posted: 2013-11-08
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: To determine if Fluorescein systemic injection during hysterectomy procedure can be useful in revealing the depth of endometrial cancer invasion.

Detailed description: All research participants will receive fluorescein injection through their existing intravenous line during their operative procedure for endometrial cancer staging. This will consist of one ampule (5 cc) injected intravenously prior to ligation of the uterine arteries. After the uterus is removed it will be sent to surgical pathology for evaluation as per routine care. The pathologist will open the uterus and evaluate the endometrium. He or she will then cut into the myometrium in an area most suspicious for invasion. The cross section of the myometrium and endometrium will be photographed while exposed to a Woods lamp. The normal myometrium will have a yellow fluorescent appearance under the Woods lamp. The cancerous tissue will have minimal fluorescence. The measurement will be taken estimating the depth of invasion of the cancer into the myometrium on the basis of its physical appearance under the Woods lamp. Cross-sectioning of the uterus is routine procedure by pathology for the intra-operative evaluation of endometrial cancer. This information routinely is provided in order to determine if lymph node staging is necessary.

The area that was measured and photographed will then be prepared for a frozen section to document depth of invasion. This is the standard procedure performed during an endometrial staging. The depth of invasion on the frozen section will be recorded. This same area will undergo histologic confirmation by permanent pathology to determine depth of invasion. The frozen section is part of routine standard of care in evaluation of endometrial cancer.

Eligibility criteria: Inclusion Criteria:

* Documented endometrial cancer and scheduled for hysterectomy as part of their treatment.
* No known allergy to fluorescein dye
* Ability to understand and sign informed consent
* 18 years of age or older

Exclusion Criteria:

* Prior hysterectomy
* Known sensitivity to fluorescein dye

Primary outcomes:
measure: Percentage of Participants With Positive Predictive Value and Negative Predictive Value From Fluorescein Visualization
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
Study officials:
affiliation: University of Arkansas
name: Alexander Burnett, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04849143: The Effectiveness of Stingless Bee Honey (Kelulut Honey) Versus Gel in Diabetic Wound Bed Preparation
Official title: The Effectiveness of Stingless Bee Honey (Kelulut Honey) Dressing Versus Conventional Gel Dressing for Wound Bed Preparation in Diabetic Patients With Cavity Wounds: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus
Wound Heal
Diabetes
Honey
Lead sponsor: Universiti Sains Malaysia
Sponsor class: OTHER
First posted: 2021-04-19
Enrollment: 76
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: TREATMENT

Brief summary: There has been no study yet on the effect of stingless bee honey (Kelulut honey) produced by Melipolini sp. in diabetic wound healing in Malaysia. Kelulut honey, apart from possessing similar pro-healing properties with other honey, is also found to have a better antioxidant capacity, anti-inflammatory, and free radical scavenging activity than Tualang honey. These effects are due to the much higher content of phenolic and flavonoid substances in Kelulut honey, the key bioactive factors promoting wound healing and preventing oxidative stress-related injury. Australian researchers have also recently discovered a novel source of the rare disaccharide trehalose in stingless bee's honey, which is highly anti-diabetic and antioxidating. This study aims to investigate the efficacy of honey against gel dressing for wound bed preparation among diabetic patients.


Eligibility criteria: Inclusion Criteria:

* Male and female
* Aged between 18-70 years old
* Patient with full thickness cavity wound
* Controlled diabetes mellitus (defined as: fasting blood glucose (FBG) \< 10 mmol/L upon selection)

Exclusion Criteria:

* Severely contaminated wound/infected
* Patient with history of allergy to honey or stingless bee product
* Patients who are immunocompromised or on chronic steroid use ( defined as use of steroid for more than 2 weeks)
* Pregnancy
* End stage renal failure (ESRF) patient

Primary outcomes:
measure: Size of granulation tissue
timeFrame: 30 days
measure: Wound size reduction
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Kota Bharu
country: Malaysia
facility: Hospital Universiti Sains Malaysia
state: Kelantan
Study officials:
affiliation: Universiti Sains Malaysia
name: Mohamad Aizat Rosli, MB ChB
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06770543: Leqvio rPMS (Regulatory Post-Marketing Surveillance in Korea)
Official title: Regulatory Post-Marketing Surveillance (rPMS) Study for Leqvio® Pre-filled Syringe(Inclisiran Sodium)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Primary Hypercholesterolemia or Mixed Dyslipidemia
Keywords: primary hypercholesterolemia,
mixed dyslipidemia
inclisiran
Leqvio
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2025-01-13
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will involve patients who received at least one dose of Leqvio for the treatment of primary hypercholesterolemia or mixed dyslipidemia according to the current label information in Korea.

Brief summary: This non-interventional study is a mandatory regular Post Marketing Surveillance(rPMS) granted by the Korean health authorities, and is conducted to assess the effectiveness and safety of Leqvio® Pre-filled Syringe(inclisiran sodium) in routine clinical practice for the approved indications (primary hypercholesterolemia or mixed dyslipidemia).


Eligibility criteria: Inclusion Criteria:

If a subject meets all of the following criteria, he/she can participate in this study:

1. Adult patients(18 years or older) who have hypercholesterolemia or mixed dyslipidemia and are prescribed Leqvio® Pre-filled Syringe(inclisiran sodium) according to domestically approved product information in real clinical practice
2. Patients who are unable to reach LDL-C target with maximum tolerated dose of statin, or patients with statin intolerance
3. Patients who provided consent to participate in the study(informed consent form)

Exclusion Criteria:

A subjects who meets any of the following criteria cannot participate in this study:

1. Contraindications in accordance with domestic prescribing information
2. Patients participating in clinical trials of other investigational drugs
3. Patients who do not provide consent to participate in the study

Primary outcomes:
measure: Incidences of adverse events/adverse drug reactions (AEs/ADRs)
timeFrame: up to 15 months
Secondary outcomes:
measure: Change from baseline in low-density lipoprotein-cholesterol (LDL-C) and lipid profiles
timeFrame: Baseline, Months 3, 9 and 15
measure: Impact of subjects' baseline characteristics and medication usage on cumulative incidence of AEs and SAEs
timeFrame: up to 15months
measure: Impact of subjects' baseline characteristics and medication usage on changes from baseline in LDL-C and lipid profiles
timeFrame: up to 15 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03165643: The DNA Methylation of ARHGEF11 in Macrosomia
Official title: Epigenetic Alteration of Rho Guanine Nucleotide Exchange Factor 11 (ARHGEF11) in Cord Blood Samples in Macrosomia Exposed to Intrauterine Hyperglycaemia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gestational Diabetes
Diabetes
Macrosomia, Fetal
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
First posted: 2017-05-24
Enrollment: 239
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Singleton term pregnant women in Peking University First Hospital were recruited in this study.

Brief summary: Background Macrosomia at birth is associated with subsequent susceptibility to obesity, abnormal glucose metabolism, hypertension and dyslipidaemia. Epigenetic reprogramming has been reported to be involved in the development of human diseases caused by suboptimal environmental or nutritional factors.

Objective The study was aiming to explore epigenetic mechanism influences on macrosomic infants exposed to intrauterine hyperglycemia.

Design The investigators performed a genome-wide analysis of DNA methylation in cord blood from macrosomic infants born to women with gestational diabetes or infants with normal birth weight born to normal glucose-tolerant women in order to identify genes related to foetal growth or early adipose tissue development. The candidate genes were then validated using SEQUENOM MassARRAY after bisulfite conversion.


Eligibility criteria: Inclusion Criteria:

-

Exclusion Criteria:

* Pregnancies complicating with hypertensive disorders, pre-gestational diabetes, thyroid diseases, renal dysfunction were excluded.

Primary outcomes:
measure: GDM was identified
timeFrame: 24-28 weeks
measure: Foetal macrosomia was identified
timeFrame: 40 weeks
measure: DNA methylation level in macrosomia
timeFrame: 40 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03819543: SURESTEP: Transcranial Direct Current Stimulation in Super Refractory Status Epilepticus
Official title: Transcranial Direct Current Stimulation in SUper REfractory STatus EPilepticus (SURESTEP): Pilot Study of a Novel Therapy in a Common Medical Emergency
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Status Epilepticus
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: Manitoba Medical Service Foundation
First posted: 2019-01-28
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether transcranial direct current stimulation affects super refractory status epilepticus.


Eligibility criteria: Inclusion Criteria:

* diagnosis of super refractory status epilepticus
* admitted to the intensive care unit
* identifiable epileptogenic focus on EEG

Exclusion Criteria:

* contraindications to scalp EEG
* lice
* scabies
* other hair/skin infection
* scalp psoriasis
* hypersensitivity
* other severe dermatological condition
* previous adverse reaction to collodion
* vagal nerve stimulator
* implantable cardioverter defibrillator
* cardiac pacemaker

Primary outcomes:
measure: Frequency of Epileptiform Activity, Per Patient-based
timeFrame: Up to 3 hours per EEG recording
Secondary outcomes:
measure: Frequency of Epileptiform Activity, Per-session Based
timeFrame: Up to 3 hours per EEG recording
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Health Sciences Centre
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Marcus Ng, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01664143: A Single-Center Study of RO5508887 in Healthy Volunteers
Official title: A Single-Center, Randomized, Investigator/Subject-Blind, Multiple Ascending-Dose, Placebo-Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO5508887 Following Oral Administration in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-08-14
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This single-center, randomized, double-blind, placebo-controlled study will evaluate the safety, pharmacokinetics and pharmacodynamics of RO5508887 in healthy volunteers. Volunteers will receive multiple-ascending doses of RO5508887 or matching placebo. The anticipated time on study treatment is 14 days.


Eligibility criteria: Inclusion Criteria:

* Adult healthy volunteers, \>/=18 years of age
* Body mass index (BMI) between 18 and 30 kg/m2 inclusive
* Use of adequate contraception methods or surgically sterile

Exclusion Criteria:

* Evidence of active or chronic disease
* Regular consumption of drugs of abuse
* Regular smoker (\>5 cigarettes per day)
* Infection with human immunodeficiency virus (HIV), hepatitis B (HBV) or hepatitis C (HCV)
* History of significant allergic reactions
* Abnormal blood pressure
* Clinical significant abnormalities (e.g., cardiovascular, laboratory values)

Primary outcomes:
measure: Safety: incidence of adverse events
timeFrame: 30 days
Secondary outcomes:
measure: Correlation of the age on pharmacokinetics of RO5508887
timeFrame: 30 days
measure: Correlation of the age on pharmacodynamics of RO5508887
timeFrame: 30 days
measure: Pharmacokinetics: plasma levels of RO5508887
timeFrame: Predose and up to 144 hours post last dose, and at follow-up
measure: Pharmacodynamics: Plasma levels of amyloid deposition markers
timeFrame: Predose and up to 144 hours post last dose
measure: Correlation of the age on safety of RO5508887
timeFrame: 30 days
Other outcomes:
Locations:
city: Strasbourg
country: France
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT01014143: Evaluating Commercial Anti-Plaque Products and Oral Rinse
Official title: Evaluating Commercial Anti-Plaque Products and Oral Rinse
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dental Plaque
Lead sponsor: Colgate Palmolive
Sponsor class: INDUSTRY
First posted: 2009-11-16
Enrollment: 26
Sex: ALL
Minimum age (years): 23
Maximum age (years): 81
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Clinical research study to determine the anti-plaque efficacy of commerical dentifrices and an oral rinse.

Detailed description: This clinical research study was to train new examiners for short term plaque clinical methodologies.

Eligibility criteria: Inclusion Criteria:

* Male or female volunteers at least 18 years of age.
* Good general health.
* Must sign informed consent form.
* Minimum of 20 natural uncrowned teeth (excluding third molars) must be present.
* No history of allergy to personal care consumer products, or their ingredients, relevant to any ingredient in the test products as determined by the dental/medical professional monitoring the study.

Exclusion Criteria:

* Subjects unable or unwilling to sign the informed consent form.
* Medical condition which requires pre-medication prior to dental visits/procedures.
* Moderate or advanced periodontal disease or heavy dental tartar (calculus).
* Two or more decayed untreated dental sites at screening.
* Other disease of the hard or soft oral tissues.
* Impaired salivary function (e.g. Sjogren's syndrome or head and neck irradiation).
* Use of medications that are currently affect salivary function.
* Use of antibiotics or antimicrobial drugs within 30 days prior to study visit #1.
* Allergy to chlorhexidine.
* Pregnant or nursing women.
* Participation in any other clinical study within 1 week prior to enrollment into this study.
* Use of tobacco products.
* Subjects who must receive dental treatment during the study dates.
* Current use of Antibiotics for pre-medication for dental treatment or for any other purpose.
* Presence of an orthodontic appliance that interferes with plaque scoring.
* History of allergy to common dentifrice ingredients.
* Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy).

Primary outcomes:
measure: Plaque Index
timeFrame: Four days
Secondary outcomes:
Other outcomes:
Locations:
city: Northfield
country: United States
facility: New Institutional Service Company
state: New Jersey
Study officials:
name: Matthew Cronin, DDS
role: PRINCIPAL_INVESTIGATOR
References: