louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00802672: Safety and Equivalence of a Generic Ciclopirox Olamine Cream Compared to the Reference Ciclopirox Cream 0.77% for the Treatment of Tinea Pedis
Official title: A Double-blind, Randomized, Parallel-group, Vehicle-controlled, Multi-center Study to Evaluate the Safety and Clinical Equivalence of a Generic Ciclopirox Olamine Cream to Ciclopirox Cream 0.77% in the Treatment of Tinea Pedis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Tinea Pedis
Keywords: Tinea Pedis
Ciclopirox Olamine
Lead sponsor: Padagis LLC
Sponsor class: INDUSTRY
First posted: 2008-12-05
Enrollment: 561
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objectives of this study were to demonstrate comparable safety and efficacy of Ciclopirox Olamine Cream (Test Product) and Ciclopirox Cream 0.77% (Reference Product) in the treatment of subjects with tinea pedis, and to show the superiority of the active treatments over that of the vehicle.


Eligibility criteria: Inclusion Criteria:

* Male or female at least 10 years of age, and otherwise healthy
* Clinically and mycologically confirmed diagnosis of symptomatic tinea pedis
* In good health with no clinically significant disease that might have interfered with study evaluations
* Study participant or legal guardian was willing and able to read and sign an IRB approved ICF, which included agreement to comply with all study requirements as indicated in the protocol. For subjects 10 to 17 years of age, an assent form for minors was completed.

Exclusion Criteria:

* History of hypersensitivity or allergy to ciclopirox
* Had any skin condition that would interfere with the diagnosis or assessment of tinea pedis
* Had a history of dermatophyte infecton unresponsive to antifungal treatment
* Had a history of alcoholism, drug abuse, or problems that would likely have made the subject unreliable for the study
* Had any condition or used any medication that, in the opinion of the Investigator, might have interfered with the conduct or results of the study or placed the prospective subject at increased risk
* Was unwilling to sign the informed consent
* Female who was pregnant or lactating

Primary outcomes:
measure: Proportion of Subjects in Each Treatment Group With Therapeutic Success
timeFrame: 6 weeks
Secondary outcomes:
measure: Proportion of Subjects With Mycological Cure
timeFrame: 6 weeks
measure: Proportion of Subjects With Clinical Cure
timeFrame: 6 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00647972: Fasting Study of Olanzapine Tablets 20 mg and Zyprexa® Tablets 20 mg
Official title: Single-Dose Fasting In Vivo Bioequivalence Study of Olanzapine Tablets (20 mg; Mylan) and Zyprexa® Tablets (20 mg; Eli Lilly) in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Viatris Inc.
Sponsor class: INDUSTRY
First posted: 2008-04-01
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The objective of this study was to investigate the bioequivalence of Mylan olanzapine 20 mg tablets to Eli Lilly Zyprexa® 20 mg tablets following a single, oral 20 mg (1 x 20 mg) dose administration under fasting conditions.


Eligibility criteria: Inclusion Criteria:

* healthy, adult subjects, 18 years and older
* able to swallow medication

Exclusion Criteria:

* institutionalized subjects
* history of any significant disease
* use of any prescription or OTC medications within 14 days of start of study
* received any investigational products within 30 days prior to start of study

Primary outcomes:
measure: The 90% confidence interval for the LSMeans ratio of CPEAK, AUCL, and AUCI for the test and reference product should be between 80.00% and 125.00% for the natural log-transformed data.
timeFrame: blood collections through 144 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Morgantown
country: United States
facility: Kendle International Inc.
state: West Virginia
Study officials:
affiliation: Kendle International Inc.
name: Thomas S Clark, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00553072: Magnesium Sulphate in Perinatal Asphyxia
Official title: Magnesium Sulphate in Perinatal Asphyxia: A Randomized Placebo Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Perinatal Asphyxia , Moderate to Severe HIE
Keywords: Asphyxia
perinatal
magnesium sulphate
Lead sponsor: Sheri Kashmir Institute of Medical Sciences
Sponsor class: OTHER
First posted: 2007-11-04
Enrollment: 40
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Magnesium sulphate has been shown to be neuroprotective. The investigators hypothesize that magnesium sulphate infusion given to babies with perinatal asphyxia should improve outcome in the immediate neonatal period.

Detailed description: Magnesium sulphate has a neuroprotective potential as has been shown by many studied in pregnant ladies with eclampsia where it helped neonates also and in mothers with preterm labour where the incidence of cerebral palsy was less. We designed a randomised controlled trial on 40 neonates with severe perinatal asphyxia to see whether it helps in the short term outcome of these neonates.

Eligibility criteria: Inclusion Criteria:

* Babies eligible for the study were:

  1. Term or post term
  2. Less than 6 hours of age and had
  3. severe perinatal asphyxia as manifested by any three of the following criteria.

     * History of fetal distress (late deceleration, Loss of beat to beat variability, fetal bradycardia, meconium stained amniotic fluid)
     * Need for immediate neonatal ventilation with bag and mask or through endotracheal intubation for 2 minutes or more after delivery
     * A 5-minute Apgar score of \< 6
     * Base deficit 15 mEq/L in cord blood or admission arterial or cord blood pH 4.Moderate to severe encephalopathy

Exclusion Criteria:

* Patients with severe IUGR
* Any condition unrelated to asphyxia
* Maternal prenatal magnesium administration
* Metabolic disorder
* Chromosomal anomalies; and
* Congenital malformations were excluded from the study

Primary outcomes:
measure: good short term out come
timeFrame: at discharge
Secondary outcomes:
measure: abnormal neurological examination and abnormal CT Head
timeFrame: at discharge
Other outcomes:
Locations:
city: Srinagar
country: India
facility: Sheri-Kashmir Institute of Medical Scienceds
state: Jammu and Kashmir
Study officials:
affiliation: SKIMS
name: Dr.Mushtaq A Bhat, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: SKIMS
name: Dr.Javeed I Bhat, M.D.
role: STUDY_CHAIR
References:
citation: Bhat MA, Charoo BA, Bhat JI, Ahmad SM, Ali SW, Mufti MU. Magnesium sulfate in severe perinatal asphyxia: a randomized, placebo-controlled trial. Pediatrics. 2009 May;123(5):e764-9. doi: 10.1542/peds.2007-3642. Epub 2009 Apr 6.
Clinical trial NCT00842972: Is Carotid Intima-media Thickness Affected by A1C Variability?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes
A1C Variability
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2009-02-12
Sex: ALL
Minimum age (years): 34
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: typeII, Fluroscopy in carotid once a year during 2 years.

Brief summary: This study was conducted to evaluate the effect of A1C variability on the progression of carotid artery intima-media thickness in type 2 diabetic patients.


Eligibility criteria: Inclusion Criteria:

* type II
* fluoroscopy in carotid once a year during 2 years

Exclusion Criteria:

* type 1 diabetes
* history or clinical evidence of coronary artery disease or cerebral or peripheral vascular disease
* the presence of albuminuria (defined as 24 hour urine albumin excretion ≥ 30 mg)
* renal dysfunction (defined as creatinine blood level ≥ 2.0 mg/dL)
* hepatic dysfunction (defined as alanine aminotransferase and/or aspartate aminotransferase blood level ≥ 3 × upper normal limit)
* smoking within the past 3 months prior to commencement of the study
* use of any medication likely to alter IMT such as calcium channel blocker, thiazolidinedione, antiplatelet agent (clopidogrel, cilostazol)
* use of glucocorticoid
* pregnancy
* severe concomitant disease such as cancer
* infection
* Cushing's syndrome
* acromegaly, or any other disorder likely to alter glycemia
* primary hypercholesterolemia
* hypothyroidism or hyperthyroidism
* use of any hormonal drugs
* alcoholism or drug abuse

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05223972: Effect of Lyon and Schroth Techniques on Adolescent İdiopathic Scoliosis
Official title: The Comparasion Effect of Lyon and Schroth Techniques on Adolescent İdiopathic Scoliosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adolescent Idiopathic Scoliosis
Lead sponsor: Kirsehir Ahi Evran Universitesi
Sponsor class: OTHER
First posted: 2022-02-04
Enrollment: 34
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Today, it is known that the conservative treatment of scoliosis is gaining importance. In addition, no study has been found comparing the efficacy of two important conservative treatment methods, the Schroth and Lyon method, in adolescent idiopathic scoliosis. Accordingly, this study was conducted to compare the effectiveness of schroth and Lyon exercises in individuals with AIS.


Eligibility criteria: Inclusion Criteria:

* Participants were between ages 10-18,
* Volunteered for the study,
* Diagnosed with adolescent idiopathic scoliosis,
* Cobb angle between 10-30 degrees,
* 0-3 Risser sign,
* Sanders classification 0-4 ,
* Lenke curve type 1

Exclusion Criteria:

* Participants who other type of scoliosis
* Previous spinal surgery
* Exercise contraindications
* Rheumatological disease
* Another neuromuscular problem were excluded from the study.

Primary outcomes:
measure: Cobb angle
timeFrame: 6 months
Secondary outcomes:
measure: Scoliosis research society-22
timeFrame: 6 months
Other outcomes:
Locations:
city: Kırşehir
country: Turkey
facility: Kırşehir Ahi Evran University
Study officials:
References:
Clinical trial NCT02441972: Clinic Study of 18F-Al-NOTA-PRGD2 in Cancer Diagnostics
Official title: Phase 1 Study of 18F-Al-NOTA-PRGD2 in Cancer Diagnostics
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Tumors
Carcinoma, Bronchogenic
Breast Carcinoma
Cancer of Head and Neck
Lymphoma, Malignant
Soft Tissue Neoplasms
Lead sponsor: Wuxi No. 4 People's Hospital
Sponsor class: OTHER
First posted: 2015-05-12
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
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 is to determine whether 18F-Al labeled RGD is safety and effective for cancer diagnosis and therapy response.

Detailed description: Observe radiation dose to healthy volunteers and patients; the correlation between integrin level and tumor/metastases uptake.

Eligibility criteria: Inclusion Criteria:

1. Volunteers or patients with age more than 18 yeas;
2. The patients have been diagnosed with cancer or suspected with cancer;
3. It must fulfill the ethical requirements and subjects have signed an informed consent.

Exclusion Criteria:

1. Pregnancy or nursing mothers;
2. Having drugs or alcohol dependence;
3. Hypersensitive to the active or inactive ingredients of the study drug;
4. Having attended other drug clinical trials within three months;
5. Cardiac functional insufficiency;
6. Hepatic and renal function insufficiency;
7. Hypertensive patients with serious complications;
8. Endangering the safety of life.

Primary outcomes:
measure: Safety data included vital signs (blood pressure, respiratory rate, heart rate, and body temperature) (composite)
timeFrame: 1 day
Secondary outcomes:
measure: radioactive distribution of normal organ, standard uptake value of tumor
timeFrame: 60 minutes
measure: Diagnostic performance analysis to assess "sensitivity,specificity,accuracy,etc"
timeFrame: 1 day-1 year
Other outcomes:
Locations:
city: Wuxi
country: China
facility: Wuxi No. 4 People's Hospital
state: Jiangsu
Study officials:
affiliation: Wuxi No. 4 People's Hospital
name: Weixing Wan, Professor
role: STUDY_CHAIR
References:
citation: Beer AJ, Haubner R, Sarbia M, Goebel M, Luderschmidt S, Grosu AL, Schnell O, Niemeyer M, Kessler H, Wester HJ, Weber WA, Schwaiger M. Positron emission tomography using [18F]Galacto-RGD identifies the level of integrin alpha(v)beta3 expression in man. Clin Cancer Res. 2006 Jul 1;12(13):3942-9. doi: 10.1158/1078-0432.CCR-06-0266.
citation: Beer AJ, Lorenzen S, Metz S, Herrmann K, Watzlowik P, Wester HJ, Peschel C, Lordick F, Schwaiger M. Comparison of integrin alphaVbeta3 expression and glucose metabolism in primary and metastatic lesions in cancer patients: a PET study using 18F-galacto-RGD and 18F-FDG. J Nucl Med. 2008 Jan;49(1):22-9. doi: 10.2967/jnumed.107.045864. Epub 2007 Dec 12.
Clinical trial NCT01589172: Evaluating the Use of Thromboelastography to Diagnose Coagulopathy After Traumatic Brain Injury
Official title: Evaluating the Use of Thromboelastography to Diagnose and Monitor Coagulopathy Associated With Pediatric Traumatic Brain Injury
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Traumatic Brain Injury
Coagulation Disorder
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2012-05-01
Enrollment: 40
Sex: ALL
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Trauma patients admitted to the Rady Children's Hospital Pediatric Intensivse Care Unit

Brief summary: The investigators will obtain thromboelastography (TEG) on pediatric patients admitted to the Rady Children's Hospital ICU after traumatic brain injury on admission to our ICU and after 24 hours of care. The investigators hypothesize that TEG will identify abnormalities of coagulation that are not identified by traditional coagulation studies, i.e. prothrombin time (PT), activated partial thromboplastin time (aPTT), and international normalized ratio (INR).


Eligibility criteria: Inclusion Criteria:

* less than 15 years of age
* evidence of intracranial bleed on CT scan or GCS \<12

Exclusion Criteria:

* No intracranial hemorrhage or
* GCS 13 - 15

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Rady Children's Hospital
state: California
Study officials:
affiliation: University of California, San Diego
name: David K Shellington, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03942172: Treatment of Balance Disorders in Parkinson's Patients Using SpotOn Balance Glasses
Official title: Treatment of Balance Disorders in Parkinson's Patients Using SpotOn Balance Glasses
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: SpotOn Therapeutics Ltd.
Sponsor class: INDUSTRY
First posted: 2019-05-08
Enrollment: 50
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: An open-label study to evaluate the effect of SpotOn balance glasses in non-demented Parkinson's patients with balance disorders.


Eligibility criteria: Inclusion Criteria:

1. Female or men
2. Diagnosed with Parkinson's disease (according to Brain Bank UK criteria)
3. Non-demented
4. Age: ≥ 30 years
5. Gait disturbances
6. Patients who are able to perform questionnaires and physical tests (including computerized tests)
7. Gave informed consent for participation in the study

Exclusion Criteria:

1. Unstable (less than 1 month) use of concomitant medications that might affect the balance system
2. Change of PD medications during the past month
3. Any medical condition or disorder that could produce gait or balance disturbances unless well controlled for at least 3 months
4. Blindness
5. Currently taking part in a clinical trial or within 30 days prior to screening
6. Any known condition which in the opinion of the investigator may impair gait or balance and/or limits the successful trial completion

Primary outcomes:
measure: Unified Parkinson's disease rating scale
timeFrame: 3 weeks
measure: TIMED UP AND GO (TUG)
timeFrame: 3 weeks
measure: Berg Balance Scale (BBS)
timeFrame: 3 weeks
measure: Non-Motor Symptoms Scale (NMSS)
timeFrame: 3 weeks
measure: 39-item Parkinson's Disease Questionnaire (PDQ-39)
timeFrame: 3 weeks
measure: Freeze of gait (FOG) Questionnaire
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: RAMBAM Health centre
Study officials:
affiliation: Rambam Hospital
name: Ilana Shlezinger, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00205972: Non Randomized Humerusshaft Fracture
Official title: Comparison (Conservative Versus Operative) of Standardized Treatment for Defined Humerusshaft Fractures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Humerusshaft Fractures
Keywords: Fractures
Humerus
Conservative treatment
Operative treatment
Lead sponsor: AO Innovation Translation Center
Sponsor class: OTHER
Collaborators: name: AOAA Switzerland
First posted: 2005-09-21
Enrollment: 300
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of the study is to radiologically compare the fracture healing as well

as the functional treatment outcome of conservative and operative treatment of

defined humerusshaft fractures after 6w./12w./and 12 month based on the

modified "constant score".

Detailed description: Radiologically compare the fracture healing as well

as the functional treatment outcome of conservative and operative treatment of

defined humerusshaft fractures after 6w./12w./and 12 month based on the

modified "constant score".

Eligibility criteria: Inclusion Criteria:

* over age 16
* fracture according to AO classifications 12A2, 12A3, 12B2
* have to be available for the FU's

Exclusion Criteria:

* open fractures
* polytraumatized patients
* multiple sclerosis, paraplegic, or other conditions having a direct impact on the healing
* pseudoarthrosis
* pathological and refractures

Primary outcomes:
measure: - Radiological comparison of fracture healing between the conservative versus operative treatment
timeFrame: 3 months to 12 months post OP
measure: - Comparison of functional outcome
timeFrame: 3 months to 12 months post OP
Secondary outcomes:
measure: - Collection of possible complication of the treatment
timeFrame: 3 months to 12 months post OP
measure: - Subject satisfaction
timeFrame: 3 months to 12 months post OP
measure: - Financial impact of the compared treatments
timeFrame: 3 months to 12 months post OP
Other outcomes:
Locations:
city: Uster
country: Switzerland
facility: Spital Uster
Study officials:
affiliation: Spital Uster
name: Gian Melcher, PD MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01942772: A Powered Ankle Foot Rehabilitation Orthosis
Official title: Design of A Powered Ankle Foot Orthoses for Ankle Rehabilitation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Ankle Injuries
Keywords: powered ankle-foot orthosis
mechanical structure
optimization
dorsiflexion
plantar flexion
gait
servomotor
ankle rehabilitation
Lead sponsor: Beijing Institute of Technology
Sponsor class: OTHER
Collaborators: name: China Rehabilitation Research Center
First posted: 2013-09-16
Enrollment: 2
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Ankle rehabilitation training becomes a tough question for the patients with ankle joint injuries especially with the hemiplegia after stroke. Here a novel powered ankle foot orthoses which can provide ankle dorsiflexion and plantar flexion assistant using electric motor is proposed in this paper. The mechanical structure of the orthoses includes wearing parts, ankle joint hinged part, driving unit, transmission mechanism and sensing units. This study provides a new method for ankle foot orthoses design and has great significance for ankle rehabilitation.


Eligibility criteria: Inclusion Criteria:

* ankle joint injuries about dorsiflexion and plantar flexion
* Ability to keep balance independently

Exclusion Criteria:

* ankle joint injuries about varus and valgus rehabilitation
* two assistants needed while walking

Primary outcomes:
measure: good performance of the ankle foot orthosis
timeFrame: one month
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Institute of Technology
state: Beijing
Study officials:
References: