louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03877692: Acute Control of Chronic Hypertension
Official title: Acute Control of Chronic Hypertension in Preeclampsia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Preeclampsia With Severe Features
Chronic Hypertension in Obstetric Context
Keywords: Hypertension
Labetalol
Lead sponsor: Albany Medical College
Sponsor class: OTHER
First posted: 2019-03-18
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to understand if administration of a personalized dose of the anti-hypertensive medication, labetalol, based on patient's history of preexisting hypertension, will be more effective at controlling severe hypertension during pregnancy, compared to the current standard dosing.

Detailed description: The investigators seek to asses the effect of preexisting hypertension on the patient's response to treatment for severe hypertension in preeclampsia with severe features. The investigators hypothesize that successive administration of 40-60-80 mg of labetolol will reduce time to blood pressure control versus the standard dosing, 20-40-80 mg labetolol, recommended by the American College of Obstetricians and Gynecologists in 2015.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Gestational age ≥ 24 weeks
* Singleton gestation
* Chronic hypertension as defined as two elevated blood pressures (SBP ≥ 140mmHg and/or DBP ≥ 90mmHg) at least 4 hours apart before 20 weeks gestation

Exclusion Criteria:

* Known allergic reaction to labetalol
* Persistent mild-moderate asthma (≥ 2 rescue inhaler uses per week in the previous month)
* Obstructive airway disease
* Bradycardia \< 70 beats/min
* Heart block \> 1st degree or history of heart failure

Primary outcomes:
measure: Time to blood pressure control
timeFrame: This outcome will be measured during antepartum admission and will start with the first dose of IV labetalol given for severe blood pressure until subsequent blood pressure check is non-severe (<160 systolic and <110 diastolic), ending with delivery
measure: Length of blood pressure control
timeFrame: This outcome will be measured during antepartum admission and will start with the first non-severe blood pressure after IV labetalol dosing until the next dose of IV labetalol is indicated (by severe blood pressure), ending with delivery
Secondary outcomes:
measure: Maternal adverse events
timeFrame: within 3 months of delivery
measure: Neonatal adverse events
timeFrame: within 28 days of delivery
Other outcomes:
Locations:
city: Albany
country: United States
facility: Albany Medical Center Obstetrics and Gynecology
state: New York
Study officials:
References:
citation: Committee Opinion No. 623: Emergent therapy for acute-onset, severe hypertension during pregnancy and the postpartum period. Obstet Gynecol. 2015 Feb;125(2):521-525. doi: 10.1097/01.AOG.0000460762.59152.d7.
Clinical trial NCT05380492: Study of VOY-101 in Patients With Advanced Non-Neovascular Age-Related Macular Degeneration
Official title: Phase 1/2a Dose Escalation Study of VOY-101 in Patients With Advanced Non-Neovascular Age-Related Macular Degeneration
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Age-related Macular Degeneration
Geographic Atrophy
Lead sponsor: Perceive Biotherapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2022-05-19
Enrollment: 45
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: The Phase 1 will enroll in a dose escalation study model (three sequential cohorts), followed by a Phase 2a cohort that will be randomized among a maximum tolerated dose arm, a lower dose arm, and a control arm.
Primary purpose: TREATMENT

Brief summary: This safety study comprises a dose escalation study of VOY-101, followed by a cohort of subjects randomized to the maximum tolerated dose arm, a lower dose arm, and control arm.

Detailed description: This is a prospective, multi-center safety phase 1/2a study to evaluate the safety of a single, unilateral intravitreal (IVT) injection of three dose levels of VOY-101 therapy in subjects with late-stage non-neovascular age-related macular degeneration (AMD).

Eligibility criteria: Inclusion Criteria:

1. Are ≥50 years of age at the time of consent.
2. Are willing and able to understand and provide written informed consent.
3. Are willing and able to return for scheduled treatment and follow-up examinations.
4. Are able to undergo ETDRS BCDVA testing and ophthalmic imaging.
5. Well-demarcated GA secondary to AMD in the absence of MNV and in the absence of history of MNV.
6. Absence of signs of non-exudative MNV.
7. Additional Ocular Inclusion Criteria
8. Meet certain genotype criteria for risk of AMD.

Exclusion Criteria:

1. Are women of childbearing potential (WOCBP) and are pregnant or unwilling to use and document use of effective contraception for the duration of the study.
2. Additional Systemic, Ocular, and Genetic Exclusion Criteria.

Primary outcomes:
measure: Safety Endpoints
timeFrame: Through 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Ophthalmic Consultants of Boston
state: Massachusetts
city: Bellaire
country: United States
facility: Retina Consultants of Texas
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
References:
Clinical trial NCT05372692: Study of LD013 in Subjects With Refractory or Relapsed Mesothelin -Positive Ovarian Cancer
Official title: Early-stage Clinical Study of Mesothelin-specific Chimericantigen Receptor T Cells (LD013) in Subjects With Refractory or Relapsed Mesothelin -Positive Ovarian Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ovarian Cancer
Lead sponsor: Zhejiang University
Sponsor class: OTHER
Collaborators: name: Nanjing Blue Shield Biotech Co.,Ltd
First posted: 2022-05-13
Enrollment: 3
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: Early-stage Clinical Study of mesothelin-specific Chimericantigen Receptor T Cells (LD013) in Subjects With Refractory or Relapsed mesothelin-positive Ovarian Cancer

Detailed description: This is a single-arm, open, dose-increasing, and extended early-stage clinical study of mesothin-specific chimeric antigen receptor T cells (LD013) in patients with mesothelin-positive drug-resistant relapsed ovarian cancer. This study included two phases: dose escalation and extension.

Eligibility criteria: Inclusion Criteria:

Fully understand and voluntarily sign informed consent.

* Aged at least 18 years old，female.
* Expected survival \> 12weeks.
* Eastern Cooperative Oncology Group (ECOG) score 0or1.
* Staining of mesothelin must be greater than 50% of the cells in the tumor tissue and with apparent expression in the membrane. Tissue obtained for the biopsy must be ≤2year prior to enrollment for screening, not have been previously irradiated or exposed to chemotherapy. If unavailable, new tissue material from a recently obtained surgical or diagnostic biopsy is mandatory for this trial；

Exclusion Criteria:

* Prior treatment with any CART therapy targeting any target.
* Subjects with severe mental disorders.
* Subjects with other malignant tumors.
* Patient is positive for Syphilis, Human Immunodeficiency Virus (HIV) , active Hepatitis B (HBsAg reactive) or Hepatitis C (HCV RNA (qualitative) is detected).
* Detectable clinically relevant central nervous system (CNS) metastases and/or pathology such as epilepsy/seizure, brain Ischemia/ hemorrhage, dementia, cerebellar disease, or autoimmune disease affecting central nervous system；
* Patients with ongoing or active infection.
* Subjects not appropriate to participate in this clinical study judged by investigators.

Primary outcomes:
measure: objective remission rate
timeFrame: 4-6weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: First affiliated hospital, School of Medicine, Zhejiang University
Study officials:
References:
Clinical trial NCT01601392: Anodal and Cathodal Transcranial Direct Current Stimulation in Stroke Recovery
Official title: Effect of Anodal Versus Cathodal Transcranial Direct Current Stimulation on Stroke Recovery: a Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Keywords: Ischemic stroke
direct current stimulation
motor threshold
National institutes of Health Stroke Scale
Barthel index scale
Measurement of motor power improvement
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2012-05-18
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study will to compare the long-term effect of anodal versus cathodal transcranial direct current stimulation (tDCS) on motor recovery in subacute stroke patients. Forty patients with subacute ischemic stroke will randomly assigned to one of three groups: Anodal, Cathodal and Sham. Each group will receive tDCS at an intensity of 2mA for 25 minutes daily for 6 consecutive days over the affected (Anodal, Sham) or unaffected (Cathodal) motor cortex. Patients will be assessed with National Institutes of Health Stroke Scale (NIHSS), the Barthel index (BI) and the Medical Research Council (MRC) muscle strength scale at baseline, after end of the 6th tDCS session, and then 1, 2 and 3 months later. Motor cortical excitability will be measured at baseline and after the 6th session in both hemispheres.


Eligibility criteria: Inclusion Criteria:

* acute hemiparesis with single thromboembolic non-hemorrhagic infarction documented by magnetic resonance imaging (MRI)
* Accept to participate in the study

Exclusion Criteria:

* extensive infarction (taking all territories of middle cerebral artery)
* severe flaccid hemiplegia
* head injury
* Any other neurological disease other than stroke
* previous administration of tranquilizer
* patients who are unable to give informed consent because of severe aphasia, or cognitive deficit.
* Patients with no motor evoked response recorded from First Dorsal Interosseus (FDI) muscle of the affected hand

Primary outcomes:
measure: Motor power improvement
timeFrame: 3 Months
Secondary outcomes:
measure: Motor cortical excitability
timeFrame: 1 Month
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Faculty of Medicine, Assiut University
Study officials:
affiliation: Assiut University
name: Eman M Khedr, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01696292: Evaluation of Mental Flexibility Through Language Tests in Adolescents With Frontal Brain Damage and in Healthy Children in Ages 8-17
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Persons With Frontal Lobe Damage With no Specific Language Disorder
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2012-10-01
Enrollment: 20
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A group of children ages 8-17 with frontal lobe damage, who are treated at the children rehabilitation center at sheba medical center

Brief summary: This study aims to shed light on the theoretical concept of mental flexibility and its manifestation in adolescents following frontal lobe damage, and to develop a test battery for young Hebrew speakers.


Eligibility criteria: Inclusion Criteria:

* frontal lobe damage
* at least one year after injury
* native hebrew speaker

Exclusion Criteria:

* specific language disorder
* premorbid learning disability

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Children Rehabilitation Department Sheba Medical Center
Study officials:
References:
Clinical trial NCT04486092: Mood Stabilizer-induced Metabolic Abnormalities in Bipolar Disorder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bipolar Disorder
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
First posted: 2020-07-24
Enrollment: 200
Sex: ALL
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: TREATMENT

Brief summary: The potential effects of microbiota in bipolar disorder (BD) with microbiota-related dysfunction have not yet been explored clinically, and the integration of microbiota and pharmacometabolomic approaches can provide us the identification of the significant effects of mood stabilizers on metabolic homeostasis, treatment response, and cognitive performance. Therefore, we propose to develop the integration of the microbiota and pharmacometabolomics knowledge base about the mood stabilizer-induced metabolic abnormalities in BD patients.


Eligibility criteria: Inclusion Criteria:

* Bipolar disorder outpatients (aged 18-65 years) who meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) diagnostic criteria and start to receive valproate (VPA) will be enrolled consecutively by trained psychiatrists.

Exclusion Criteria:

* Exclude are patients who had DSM-V diagnosis for substance abuse within the past three months
* Had treated with antibiotics and/or functional foods (probiotics and/or prebiotics) for at least one month before entering study
* Presence of stomach/gut problems such as chronic diarrhea, constipation, gas, heartburn, bloating, etc.
* Had an organic mental disorder, mental retardation, dementia, or other diagnosed neurological illness
* Had a surgical condition or a major physical illness
* Were pregnant or breast-feeding
* Had any concomitant DSM-V Axis I diagnoses together with somatic or neurologic illnesses interfering psychiatric evaluation.

Primary outcomes:
measure: Gut microbiota composition
timeFrame: 12 weeks
Secondary outcomes:
measure: Metabolic syndrome
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: National Cheng Kung University (NCKU) Hospital
Study officials:
References:
Clinical trial NCT01779492: A Randomized, Open-label, Multiple-dose, Two-sequence, Two-period Crossover Study to Investigate The Pharmacokinetics Between a GL2907 and Oxycontin CR Tab. 10mg in Healthy Male Volunteers
Official title: A Randomized, Open-label, Multiple-dose, Two-sequence, Two-period Crossover Study to Investigate The Pharmacokinetics Between a GL2907 and Oxycontin CR Tab. 10mg in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Oxycodone, controlled release formulation
Lead sponsor: GL Pharm Tech Corporation
Sponsor class: INDUSTRY
First posted: 2013-01-30
Enrollment: 24
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this clinical trial is to compare the pharmacokinetic characteristics of GL2907 XL 20mg tablet and Oxycontin CR 10mg tablet.

Detailed description: GL2907 XL 20mg tablet is controlled released formulation which is made by GL Pharm Tech.

Eligibility criteria: Inclusion Criteria:

* 20\~45 years old, Healthy Adult Male Subject
* Body Weight ≥ 50kg and Ideal Body Weight ≤ ±20%

Exclusion Criteria:

* ALT or AST \> 1.25 times (Upper Normal Range)
* Total Bilirubin \> 1.5 times (Upper Normal Range)
* CPK \> 2 times (Upper Normal Range)
* BUN or Creatinine \> Normal Range
* Systolic BP \> 160mmHg or \< 80mmHg, Diastolic BP \> 100mmHg or \< 50mmHg

Primary outcomes:
measure: Cmax,ss
timeFrame: 48h
measure: AUCτ
timeFrame: 24h
Secondary outcomes:
measure: Tmax
timeFrame: 48h
measure: t1/2
timeFrame: 48h
measure: Vz/f
timeFrame: 48h
measure: CL/F
timeFrame: 48h
measure: Cmin,ss
timeFrame: 48h
measure: Cave,ss
timeFrame: 48h
measure: degree og fluctuation
timeFrame: 48h
measure: swing
timeFrame: 48h
measure: R
timeFrame: 48h
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: AJOU University Hospital
state: Gyeonggido
Study officials:
affiliation: Ajou University School of Medicine
name: Doo-Yeoun Cho, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03735992: Mind-body Medicine for Patients With Malignant Hematological Diseases
Official title: Mind-body Medicine as a Supportive Strategy for Patients With Malignant Hematological Diseases: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hematologic Neoplasms
Keywords: Hematologic Neoplasms
Supportive Therapy
Fatigue
Mind-body medicine
Complementary and alternative medicine
Lead sponsor: Universität Duisburg-Essen
Sponsor class: OTHER
Collaborators: name: Robert Bosch Medical Center
First posted: 2018-11-08
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized controlled trial aims to investigate the effectiveness of a mind-body group program as a supprtivemanagement strategy for fatigue in patients with malignant hematological diseases.


Eligibility criteria: Inclusion Criteria:

* Patients with malignant hematological diseases in complete remission after primary chemotherapy and/or radiation
* Physical and mental ability to attent 8 of 11 group units

Exclusion Criteria:

* Chemotherapy, radiation, or rehabilitation programm during the study period
* Pregnancy
* Participation in other studies with behavioral interventions during the study period

Primary outcomes:
measure: General Fatigue
timeFrame: week 12
Secondary outcomes:
measure: General Fatigue
timeFrame: week 24
measure: Physical Fatigue
timeFrame: week 12
measure: Physical Fatigue
timeFrame: week 24
measure: Reduced Activity
timeFrame: week 12
measure: Reduced Activity
timeFrame: week 24
measure: Reduced Motivation
timeFrame: week 12
measure: Reduced Motivation
timeFrame: week 24
measure: Mental Fatigue
timeFrame: week 12
measure: Mental Fatigue
timeFrame: week 24
measure: Qaulity of life
timeFrame: week 12
measure: Qaulity of life
timeFrame: week 24
measure: Depression
timeFrame: week 12
measure: Depression
timeFrame: week 24
measure: Anxiety
timeFrame: week 12
measure: Anxiety
timeFrame: week 24
measure: Stress
timeFrame: week 12
measure: Stress
timeFrame: week 24
measure: Sleep
timeFrame: week 12
measure: Sleep
timeFrame: week 24
measure: Physical activity
timeFrame: week 12
measure: Physical activity
timeFrame: week 24
measure: Fatigability
timeFrame: week 12
measure: Fatigability
timeFrame: week 24
measure: Adverse Events
timeFrame: week 12
measure: Adverse Events
timeFrame: week 24
Other outcomes:
measure: Treatment Expectation
timeFrame: week 0
measure: Treatment Satisfaction
timeFrame: week 12
Locations:
city: Stuttgart
country: Germany
facility: Robert-Bosch-Krankenhaus, Abteilung für Hämatologie, Onkologie und Palliativmedizin
Study officials:
affiliation: Center for Integrative Medicine and Health, University Hospital Essen, University of Duisburg-Essen
name: Gustav Dobos, Prof. MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01912092: Askina Calgitrol Paste Diabetic Foot Ulcers
Official title: A NON-CONTROLLED PROSPECTIVE COHORT STUDY OF THE USE OF ASKINA® CALGITROL® PASTE + STANDARD OF CARE ON MILDLY INFECTED, NON-ISCHAEMIC DIABETIC FOOT ULCERS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Foot Ulcer (DFU)
Lead sponsor: BBraun Medical SAS
Sponsor class: INDUSTRY
First posted: 2013-07-30
Enrollment: 22
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 assess the efficacy of Askina® Calgitrol® Paste in reducing local infection in subjects treated for mildly infected Diabetic Foot Ulcers (DFU) with Askina® Calgitrol® Paste.


Eligibility criteria: Inclusion Criteria:

* Subject older than 18 years old
* Provision of written consent by the subject themselves
* Subjects with a Texas stage I-B wound below the malleolus: superficial and infected (Wagner-Armstrong classification system).
* Subjects with a mildly infected wound according to the Infectious Diseases Society of America (IDSA).
* Size of wound \>2 cm2.
* Absence of ischaemia of the lower limb as assessed by :

  1. Transcutaneous oxygen pressure (TcPO2) \> 30 mmHg.
  2. Toe pressure \> 50 mmHg.
  3. Ankle pressure \> 70 mmHg.
* Capable of following Study instructions.
* Compliant with treatment and in particular with off-loading regime.
* Stable management of their diabetes as defined by an HbA1C (%) of 12%

Exclusion Criteria:

* Subjects who are \<18 years old.
* Subjects with a documented sensitivity to alginates or silver.
* Subjects taking a medication or using a device comprising silver.
* Subjects already taking antibiotics before enrolment
* Subjects undergoing dialysis.
* Subjects using therapy known to be immune-compromising such as systemic anti-neoplastic drugs and/or systemic cortico-steriods.
* Pregnancy
* Breast-feeding
* Currently participating in another clinical trial, or who have participated in another clinical trial in the last 6 weeks or who have previously taken part in this study

Primary outcomes:
measure: Clinical signs of local infection (Presence of erythema, pain, tenderness, warmth or induration)
timeFrame: At day 0, day 2 and weekly in a period of a maximum of 6 weeks
Secondary outcomes:
measure: Adverse events or Adverse device related event
timeFrame: At day 2 and weekly in a period of a maximum of 6 weeks
measure: Evaluation of wound bed (necrosis, slough, granulation, epithelialisation)
timeFrame: At day 0, day 2 and weekly in a period of a maximum of 6 weeks
measure: Ease of use of Askina Calgitrol Paste
timeFrame: Daily or at every change of dressing, in a period of a maximum of 6 weeks
measure: Wound surface area
timeFrame: At day 0, day 2 and weekly in a period of a maximum of 6 weeks
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Diabetic Foot and metabolic diseases clinic
city: Mila
country: Italy
facility: IRCCS Casa di Cura MultiMedica
Study officials:
References: