louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00144534: Long-term Treatment Study of MRA for Rheumatoid Arthritis (RA) From Study MRA213JP
Official title: An Open-label, Extension, Phase III Study to Evaluate the Long-term Safety and Efficacy of MRA in Patients With RA Who Participated in Study MRA213JP
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Lead sponsor: Chugai Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2005-09-05
Enrollment: 115
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an open-label, extension, Phase III study to evaluate the long-term safety and efficacy of MRA in patients with RA who participated in Study MRA213JP.


Eligibility criteria: Inclusion criteria

* Either MRA or placebo was administered at least 3 times in the preceding study, and there were confirmed to be no problems with respect to safety.
* In the case of Patients whose participation in the current study was judged to be inappropriate because of problems in the preceding study with respect to safety, these Patients must have been in the methotrexate dose group in the preceding study.

Exclusion criteria

* Administered drugs such as infliximab, etanercept, and leflunomide within 12 weeks before administration of the study drug
* Evaluated as belonging to Steinbrocker's class IV within 4 weeks before administration of the study drug
* Have not been registered by 3 months after the full code-breaking of the preceding study
* Were administered plasma exchange therapy between initiation of the preceding study and the initial administration in the current study
* Treated surgically (except for local surgery) within 4 weeks before administration of the study drug

Primary outcomes:
measure: Efficacy:the frequency of amelioration of at least 20% in terms of the ACR criteria
timeFrame: throughout study
measure: Frequency and degree (severity and seriousness) of adverse events and adverse drug reactions
timeFrame: throughout study
measure: Pharmacokinetics of the serum MRA concentration
timeFrame: 0W,4W,8W,12W,LOBS
Secondary outcomes:
measure: Efficacy:time courses of DAS28, frequencies of amelioration of at least 20%, 50%, and 70% in terms of the ACR criteria, each item in the ACR core set
timeFrame: 0W,4W,8W,12W,LOBS
Other outcomes:
Locations:
Study officials:
affiliation: Chugai Pharmaceutical
name: Takahiro Kakehi
role: STUDY_DIRECTOR
References:
Clinical trial NCT00451334: Safety and Efficacy of Using GlucoSat Technology For Non-Invasive Glucose Measurement
Official title: Safety and Efficacy of Using GlucoSat Technology For Non-Invasive Glucose Measurement
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetes
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2007-03-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: OTHER

Brief summary: This study is a prospective, open label, controlled, single center study. 40 patients will be recruited for the study, according to patients' inflow and meeting eligibility criteria.

Primary Goal

\* To evaluate the safety of the GlucoSat technology as a non-invasive blood glucose level measurement technology.

Secondary Goal

\* To assess the efficacy of the GlucoSat technology as a non-invasive blood glucose level measurement technology.

Detailed description: Primary Endpoint Parameter

• Primary study endpoint will be to establish the safety of using the GlucoSat technology as a non-invasive glucose level measurement technology. Safety will be established by paucity of adverse events. Adverse Events occurrence will be documented throughout the study.

Secondary Endpoint Parameters

Efficacy of the GlucoSat technology will be assessed by:

* Proving the accuracy and precision of the GlucoSat technology by comparing the glucose level measured by the GlucoSat device to the glucose level observed by any certified for clinics invasive device. Inter device variability should be within 15%.
* Patient satisfaction questionnaire.
* Physician satisfaction will be assessed by questionnaire.

Eligibility criteria: Inclusion Criteria:

* Male/Female aged 18 and up.
* Subject was diagnosed as a diabetes patient or healthy subject.
* Subject able to comprehend and give informed consent for participation in this study.
* Signed Informed Consent Form

Exclusion Criteria:

* Pregnancy or breast feeding.
* Patients treated with steroid.
* Concomitant Coumadin use
* Recent (within the last 3 months) myocardial infarction or CVA (stroke).
* Any chronic unstable disease within the last 3 months.
* Acute bleeding disorders.
* HIV positive.
* Hepatitis B/C positive.
* BMI\>37
* Needing emergency surgery
* Known cognitive or psychiatric disorder
* Physician objection
* Concurrent participation in any other clinical trial

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Zrifin
country: Israel
facility: Assaf-Harofeh Medical Center
Study officials:
name: Shai Efrati, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00513734: A Comparison of Hydrogel Dressings and Ocular Lubricants in the Prevention on Corneal Damage in the Critically Ill
Official title: Randomised Trial Comparing the Efficacy of Ocular Lubricant (Lacrilube) and Polyacrylamide Hydrogel Dressing (Geliperm) for the Prevention of Exposure Keratopathy in the Critically Ill
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Keratitis
Keywords: keratopathy
exposure
intensive care
eye
ulcer
Corneal
Lead sponsor: Barts & The London NHS Trust
Sponsor class: OTHER
First posted: 2007-08-09
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Corneal damage in critically ill patients is common. There are currently two popular methods of treatment in the UK; hydrogel dressings and lubricating ointment. We propose to randomise patients to have a different treatment for each eye and see which one is more effective.

Detailed description: Microbial keratitis, particularly pseudomonas-related, has been widely reported amongst Intensive therapy unit (ITU) patients and the need for effective eye care in ITU has been recognised for some time. We compare two popular methods of eye care; a hydrogel dressing and lacrilube ointment. Each recruited patient had each eye randomised to different treatments. Daily ophthalmology ward rounds were undertaken to identify any corneal exposure keratopathy. Patients were removed from the trial if one eye developed significant exposure needing treatment.

Eligibility criteria: Inclusion Criteria:

* All patients admitted to Intensive care and expected to stay for more than 2 days

Exclusion Criteria:

* Primary orbital injury

Primary outcomes:
measure: Development of clinically significant corneal exposure
timeFrame: throughout length of admission to ITU
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Lead Clinicain, Dept. of Intensive Care Medicine, Royal London Hospital, London E1 1BB
name: Marie Healy, FRCA
role: STUDY_DIRECTOR
References:
Clinical trial NCT06661434: Prevalence of Obesity Among Adult Patients With Congenital Heart Disease: a Population-based Study
Official title: Prevalence of Obesity Among Adult Patients With Congenital Heart Disease: a Population-based Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Congenital Heart Disease
Keywords: obesity
adult congenital heart disease
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2024-10-28
Enrollment: 7157
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The ACHD population in east Denmark

Brief summary: The study was conductede to examined the prevalence of obesity in a large Danish ACHD cohort, stratified according to age, sex and disease severities. To do so, ACHD patients were matched by age and sex with controls from the contemporary Copenhagen General Population Study


Eligibility criteria: Inclusion Criteria:

* Congenital heart disease
* BMI within the last five years

Exclusion Criteria:

* Without BMI or not congenital heart disease

Primary outcomes:
measure: BMI
timeFrame: Within the last five years
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Cardiology, Rigshospitalet
Study officials:
References:
Clinical trial NCT04712734: A Study to Evaluate Iloperidone Long-acting Injection (LAI) for the Treatment of Schizophrenia
Official title: An Open-label, Adaptive, Repeat-dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Iloperidone Long-acting Injection (LAI) in Patients With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Schizophrenia
Lead sponsor: Vanda Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2021-01-15
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a multicenter, open-label, adaptive, repeat-dose study to evaluate the safety, tolerability, and pharmacokinetics of iloperidone long-acting injection (LAI) in patients with schizophrenia.


Eligibility criteria: Inclusion Criteria:

* Willing and able to provide written informed consent.
* Male or female patients 18 to 65 years of age (inclusive).
* Clinical diagnosis of schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorder (DSM-5) for at least 1 year.
* Symptomatically stable within the past two months.

Exclusion Criteria:

* Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer.
* Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs.
* Pregnant or nursing (lactating) women.
* A positive test for drugs of abuse.

Primary outcomes:
measure: Pharmacokinetics of iloperidone and its metabolites following repeat-dosing of iloperidone given as a long-acting injection.
timeFrame: 24 weeks
measure: Assessment of safety and tolerability of repeat-dosing of iloperidone given as a long-acting injection.
timeFrame: 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Garden Grove
country: United States
facility: Vanda Investigational Site
state: California
city: Gaithersburg
country: United States
facility: Vanda Investigational Site
state: Maryland
city: Marlton
country: United States
facility: Vanda Investigational Site
state: New Jersey
Study officials:
References:
Clinical trial NCT04277234: Functional Characterisation of Post-stroke Fatigue
Official title: Functional Characterisation of Post-stroke Fatigue: a Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stroke
Stroke Sequelae
Keywords: fatigue
fatigability
functional impairment
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier Universitaire UCLouvain Namur
name: CHU Ambroise-Paré - Mons
First posted: 2020-02-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: adults

Brief summary: Post-stroke fatigue is highly prevalent and disabling. However, its causes and consequences in the chronic phase are not fully understood. The aim of this cross-sectional study is to explore functional correlates of post-stroke fatigue in the chronic phase.


Eligibility criteria: Inclusion Criteria:

* Mini Mental State Evaluation \> 24
* Stroke \> 6 months ago

Exclusion Criteria:

* Current active infection
* Multiple stroke
* Other affection of the central nervous system
* Medication potentially inducing severe fatigue
* Hospital admission during last month
* Severe Apraxia
* Severe Aphasia

Primary outcomes:
measure: Fatigue Severity Scale (FSS)
timeFrame: assessment during 1 day study visit
Secondary outcomes:
measure: Pittsburgh Sleep quality index
timeFrame: assessment during 1 day study visit
measure: ACTIVLIM specific to patients with stroke
timeFrame: assessment during 1 day study visit
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: assessment during 1 day study visit
measure: 6-minute walk test
timeFrame: assessment during 1 day study visit
measure: Neuromuscular Fatigability Index
timeFrame: assessment during 1 day study visit
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Cliniques universitaires Saint-Luc
Study officials:
References:
citation: Rahamatali M, De Bont N, Valet M, Halkin V, Hanson P, Deltombe T, Lejeune T, Selves C. Post-stroke fatigue: how it relates to motor fatigability and other modifiable factors in people with chronic stroke. Acta Neurol Belg. 2021 Feb;121(1):181-189. doi: 10.1007/s13760-020-01453-9. Epub 2020 Aug 1.
Clinical trial NCT02731534: Efficacy Study of Intravenous Iron Preparation to Iron Deficiency Anemia
Official title: Phase III Study of Z-213 in Subjects With Iron-deficiency Anemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Iron Deficiency Anemia
Lead sponsor: Zeria Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2016-04-07
Enrollment: 238
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to confirm the non-inferiority of Z-213 compared to Saccharated Ferric Oxide using the maximum change in Hb from baseline over 12 weeks in patients with Iron-deficiency Anemia (IDA)


Eligibility criteria: Inclusion Criteria:

* Patients with iron deficiency anemia

Exclusion Criteria:

* Patients with anemia caused by conditions other than iron deficiency
* Patients with abnormal laboratory test values at screening for Serum phosphorus, Aspartate aminotransferase, Alanine aminotransferase
* Patients with liver, kidney or circulatory system disease
* Patients with a history or present illness that is a malignant tumor or autoimmune disease
* Patients who underwent intravenous administration of an iron preparation, administration of an erythropoiesis stimulation agent or blood transfusion within 8 weeks before the screening
* Patients who underwent oral administration of an iron preparation (including an over-the-counter drug or supplement) within 4 weeks before the screening

Primary outcomes:
measure: Maximum change in Hb value
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in Hb value
timeFrame: 12 weeks
measure: Proportion of responders
timeFrame: 12 weeks
measure: Proportion of subjects with normalization in Hb value
timeFrame: 12 weeks
measure: Proportion of cumulative dosage
timeFrame: 12 weeks
measure: Dosing period and the number of doses
timeFrame: 12 weeks
measure: Incidence of Adverse Events
timeFrame: 12 weeks
measure: Incidence of Adverse Drug Reactions
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Tokyo
country: Japan
Study officials:
References:
Clinical trial NCT01145534: Evaluation of Cissus Verticillata L. Infusion in Controlling Type 2 Diabetes
Official title: Phase 1 Study for Testing Efficacy of Cissus Verticillata L Infusion in Controlling Glucose Concentration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Diabetes
Keywords: diabetes,
medicinal plants,
glucose
Lead sponsor: Federal University of Paraíba
Sponsor class: OTHER
Collaborators: name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2010-06-16
Enrollment: 15
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to investigate whether the infusion of a medicinal plant (Cissus verticillata L.) would be effective in reducing glucose levels in blood and saliva of type 2 Diabetes patients.

Detailed description: Type 2 diabetes mellitus is regarded as one of the most prevalent disease of the adult population. In many developing countries, this condition is regarded as major public health problem. Type 2 diabetes is a metabolic disorder characterized by high blood glucose related with a condition of insulin resistance and relative insulin deficiency. As Diabetes progresses, medications are necessary to control glucose levels.

The aim of this study was to investigate whether the infusion of a medicinal plant (Cissus verticillata L.) would be as effective as a regular drug (glibenclamide) in reducing glucose levels in blood and saliva of type 2 Diabetes patients. Several medicinal plants have been used as potential medication for controlling glucose levels in Diabetes patients. Few studies have explored this effect related to Cissus verticillata L.infusion, though it has been indicated by folk medicine of some Latin American countries.

Eligibility criteria: Inclusion Criteria:

* subjects of 30 up to 80 years of age
* positive diagnostic for type 2 diabetes mellitus (blood glucose level above 126 mg/dL)
* patients that signed the informed consent

Exclusion Criteria:

* patients with renal and hepatic disfunction,
* patients with cardiac problems or other systemic alterations (allergies, pulmonary and gastrointestinal problems)
* pregnant women

Primary outcomes:
measure: blood glucose
timeFrame: 60 days
Secondary outcomes:
measure: Salivary glucose level
timeFrame: 60 days
Other outcomes:
Locations:
city: Patos
country: Brazil
facility: Centro de Especialidades Odontologicas
state: Paraiba
Study officials:
affiliation: Federal University fo Paraiba
name: Fabio C Sampaio, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT05076734: Cell- Based Noninvasive Prenatal Testing (NIPT): Single Cell Prenatal Diagnosis (SCPD)
Official title: Technology Development for Noninvasive Prenatal Genetic Diagnosis Using Maternal Peripheral Blood: N o Return of Results -Luna Collection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy Related
Lead sponsor: Luna Genetics
Sponsor class: INDUSTRY
First posted: 2021-10-13
Enrollment: 157
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of the overall study is to develop improved methods for recovery of fetal cells from the mother's blood in order to develop a clinically useful form of cell-based, diagnostic, noninvasive prenatal testing (NIPT). Luna Genetics will analyze blood samples from healthy pregnant women. A phlebotomist will be sent to any location in the United States to collect the blood sample. Sample identifiers will be removed as the first step so that laboratory personnel will not see or have access to identifiers. No information will go back to patients or their physicians.


Eligibility criteria: Inclusion Criteria:

* Pregnant
* 18years or older

Exclusion Criteria:

* Language barrier (non-English speaking and no adequate interpreter)
* Maternal age of less than 18 years
* Higher order multiple pregnancy (triplet or greater)
* Not currently pregnant

Primary outcomes:
measure: Fetal Cell Recovery and genetic analysis
timeFrame: 2 months
measure: Redraw for Fetal Cell Recovery and genetic analysis
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Luna Genetics
state: Texas
Study officials:
affiliation: Luna Genetics
name: Arthur Beaudet, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01265134: Efficacy of Arch Insoles in the Dynamic Postural Control for the Elderly
Official title: Efficacy of Arch Insoles in the Dynamic Postural Control for the Elderly
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Balance; Distorted
Keywords: the elders
falling
loss balance
Lead sponsor: Taipei Medical University WanFang Hospital
Sponsor class: OTHER
First posted: 2010-12-22
Enrollment: 60
Sex: FEMALE
Minimum age (years): 65
Maximum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: the elders

Brief summary: The purpose of this study is to measure the ability of balance controlling and test the evaluation of clinical trials with different arch insoles. The investigators want to find out the difference and efficacy of arch insoles in the dynamic postural control for the elderly.


Eligibility criteria: Inclusion Criteria:

* no cognition problem. (mini-mental state examination \[MMSE\] \> 23)
* no sensory or motor problem
* no use drugs about balance control
* lower extremity without any traumatic injury

Exclusion Criteria:

* Cognition impairment
* with specific neurological deficits resulting from neuropathy, neuromuscular disorders or spinal stenosis
* use drugs about balance control
* total joint arthroplasty

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipe
country: Taiwan
facility: Taipei Medical University - Wanfang Hospital
Study officials:
affiliation: Taipei Medical University WanFang Hospital
name: Chi-Hsien Chen
role: PRINCIPAL_INVESTIGATOR
References: