louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01660295: Pharmacokinetics of Certoparin in Subjects With Renal Insufficiency and Healthy Subjects
Official title: An Open-label, Single Center, Parallel-group Study to Compare the Single- and Repeated-dose Pharmacokinetics of Stepwise Increasing Doses of Subcutaneous Certoparin (3000 IU o.d., 3000 IU b.i.d., 8000 IU o.d., and 8000 IU b.i.d.) in Subjects With Severe Renal Insufficiency and Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Renal Insufficiency
Keywords: Severe renal insufficiency certoparin
Severe renal insufficiency
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2012-08-08
Enrollment: 32
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will assess the pharmacokinetics in subjects with severe renal insufficiency and healthy subjects.


Eligibility criteria: Inclusion criteria:

* Healthy subjects OR
* Subjects with severe renal insufficiency

Exclusion criteria:

* Hypersensitivity to study medication
* Genetic abnormality or disease of clotting system
* Prior major surgery or bleeding
* Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Plasma aXa-Profile: C0
timeFrame: 5 days
measure: Dose regimen, systemic total exposure to aXa (AUC0-τ,ss)
timeFrame: 5 days
measure: Plasma aXa-Profile: Cmax
timeFrame: 5 days
measure: Plasma aXa-Profile: AUC
timeFrame: 5 days
Secondary outcomes:
Other outcomes:
Locations:
city: H-8230 Balatonfüred
country: Hungary
facility: DRC Drug Research Center Ltd., H-8230 Balatonfüred
state: Ady E. u.
Study officials:
References:
Clinical trial NCT02256995: uChek Pilot Study for Urinalysis in the Antenatal Care Setting
Official title: A Prospective Observational Pilot Study to Test the Feasibility of Smartphone Enabled uChek Urinalysis Device in Bangladesh
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Preeclampsia
Eclampsia
Pregnancy
Proteinuria
Keywords: Pregnancy
Preeclampsia
Eclampsia
Proteinuria
Lead sponsor: Maternova Research
Sponsor class: OTHER
Collaborators: name: Merck for Mothers
name: HOPE Foundation for Women and Children of Bangladesh
First posted: 2014-10-06
Enrollment: 375
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: There are two unique subject populations in this study. One group consists of pregnant women whose urine will be analyzed- hereafter referred to as the Patient Participants. The second group is a cohort of medical professionals who will answer a questionnaire about the usability of the device, relating to the second objective, hereafter referred to as the Medical Staff Participants. The following parameters have been answered in reference to the Patient Participants.

Brief summary: A prospective observational study to test the feasibility of smartphone enabled uChek urinalysis device to detect biomarkers (protein, microalbumin and protein:creatine ratio) in urine, indicative of preeclampsia/eclampsia at over 22 weeks of gestation and assess attitudes of clinicians towards uChek as a new technology for urinalysis.


Eligibility criteria: Inclusion Criteria:

* Pregnant with a gestational age of over 22 weeks and ability to follow pregnancy till delivery.

Exclusion Criteria:

* Study participant is unwilling to take part in study or participants with pathological conditions that restrict them from providing a urine sample without catheterization.

Primary outcomes:
measure: Feasibility of using uChek for standard urinalysis in an antenatal care (ANC) setting
timeFrame: 6 months
Secondary outcomes:
measure: Impressions and attitudes of healthcare workers re: uChek for urinalysis in ANC
timeFrame: 6 months
Other outcomes:
measure: Feasibility of using uChek for expanded urinalysis panel in ANC
timeFrame: 6 months
Locations:
city: Cox's Bazar
country: Bangladesh
facility: Hope Hospital for Women and Children
Study officials:
affiliation: Hope Bangladesh
name: Janardana Sharma, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00527995: Acute Effects of Sildenafil on Endothelial Function in People With Diabetes
Official title: Acute Effects of Sildenafil on Flow Mediated Dilatation and Cardiovascular Autonomic Nerve Function in Type 2 Diabetic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Endothelial Dysfunction
Lead sponsor: Ruhr University of Bochum
Sponsor class: OTHER
First posted: 2007-09-11
Enrollment: 40
Sex: MALE
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a double-blind, placebo-controlled, cross-over trial using a single dose of 100 mg sildenafil or placebo in 40 subjects with T2DM without known cardiovascular disease. Effects on haemodynamic parameters, flow mediated dilatation (FMD) in brachial artery, cardiovascular autonomic function tests, and spontaneous baroreflex sensitivity (BRS) were investigated.


Eligibility criteria: Inclusion Criteria:

* age 35-70
* type 2 diabetes mellitus
* impotence
* with and without hypertension, hypercholesteremia

Exclusion Criteria:

* patients with history of cardiovascular and malignant disease,
* advanced nephropathy (creatinine≥2.2mg/dl)
* hepatopathy (liver enzymes higher than the double of normal values)
* patients taking nitrates
* CHF: NYHA \> II
* Stable angina: CCS \> II

Primary outcomes:
measure: Improvement of flow mediated dilatation of the brachial artery following a single dose of 100mg Sildenafil.
timeFrame: 60 minutes
Secondary outcomes:
measure: Change in hemodynamics and cardiovascular parasympathetic and sympathetic nerve function using time domain and frequency domain indexes of heart rate variability (HRV) and baroreflex sensitivity (BRS) following a single dose of 100mg Sildenafil.
timeFrame: 60 minutes
Other outcomes:
Locations:
city: Duesseldorf
country: Germany
facility: German Diabetes Center
state: North Rhine-Westphalia
Study officials:
affiliation: Heart and Diabetes Center NRW
name: Alin Stirban, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: German Diabetes Center Duesseldorf
name: Dan Ziegler, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00595595: Development of a Model to Evaluate Regenerative Endodontic Techniques Using Extract Human Teeth
Official title: Development of a Model to Evaluate Regenerative Endodontic Techniques
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dental Pulp Regeneration
Dental Pulp Diseases
Keywords: Dental Pulp
Regenerative Medicine
Odontoblasts
Stem Cells
Growth factor differentiation of stem/progenitor cells
Odontoblast-specific cell phenotypes
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
First posted: 2008-01-16
Enrollment: 1080
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presenting for surgical removal of impacted teeth

Brief summary: Millions of teeth are saved each year by root canal therapy. Although current treatment modalities offer high levels of success for many conditions, an ideal form of therapy might consist of regenerative approaches in which diseased or necrotic pulp tissues are removed and replaced with healthy pulp tissue in order to revitalize teeth.

Detailed description: The long term goal of this research project is to develop a method to regenerate dental pulp-like tissue as an alternative method to conventional root canal treatment. The objective of this study is to identify the methods necessary to regenerate dental pulp-like tissue in human teeth. We will collect small (\~4X4mm) pieces of oral mucosa that are normally removed during surgical tooth extractions, isolate human postnatal progenitor/stem cells and, using an in vitro cell culture system, combined isolated cells with various scaffolds and test compounds to determine optimal conditions to differentiate pulp-like tissue (eg, odontoblasts, fibroblasts, endothelium, etc) grown in segments of human roots.

Eligibility criteria: Inclusion Criteria:

* Pre-existing indication for surgical extraction of impacted teeth
* Age 16-65

Exclusion Criteria:

* Ages less than 16 or over 65
* No pre-existing indication for surgical extraction of impacted teeth

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: The University of Texas Health Science Center at San Antonio
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center at San Antonio
name: Kenneth M Hargreaves, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00522795: Neoadjuvant Paclitaxel Poliglumex, Cisplatin and Radiation for Esophageal Cancer: A Phase II Trial (CTI#X64001)
Official title: BrUOG-E-215-Neoadjuvant Paclitaxel Poliglumex (PPX; CT-2103), Cisplatin and Radiation for Esophageal Cancer: A Phase II Trial. (CTI#X64001
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Esophageal Cancer
Keywords: Esophageal Cancer
Lead sponsor: Brown University
Sponsor class: OTHER
Collaborators: name: University of Maryland Greenebaum Cancer Center
First posted: 2007-08-30
Enrollment: 40
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Neoadjuvant Paclitaxel Poliglumex (PPX; CT-2103), Cisplatin and Radiation for Esophageal Cancer: A Phase II Trial. (CTI#X64001

Detailed description: 32 patients with esophageal or gastroesophageal junction cancer will receive Radiation:50.4 Gy at 180cGy fraction/day for 28 treatments and Paclitaxel Poliglumex (PPX) and Cisplatin weekly times 6 followed by surgery.

Eligibility criteria: Inclusion Criteria:

* Patients are required to have pathologically confirmed adenocarcinoma or squamous cell carcinoma of the esophagus or gastroesophageal junction
* Patients may have celiac adenopathy
* There must be no evidence of distant organ metastases
* No prior chemotherapy or radiation for esophageal cancer
* Patients must be \> 18 years of age, and non pregnant
* Patients must have an ANC \> 1,500/ul, platelets \> 100,000/ul, creatinine \< 2.0 and bilirubin \< 1.5 x ULN-ECOG performance status 0-1.
* Female patients, must either be not of child bearing potential or have a negative pregnancy test within 14 days of starting study treatment. Patients are considered not of child bearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal. Pregnant or lactating females are not eligible
* No contraindications to esophagectomy
* Signed informed consent

Exclusion Criteria:

* Active or uncontrolled infection
* Patients must not have other coexistent medical condition that would preclude protocol therapy.
* Any concurrent chemotherapy not indicated in the study protocol or any other investigational agent(s).

Primary outcomes:
measure: Complete Pathologic Response
timeFrame: At Surgery approximately 4weeks after last treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Providence
country: United States
facility: Lifespan Hospitals
state: Rhode Island
Study officials:
affiliation: Brown University
name: Howard Safran, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05915195: Effects of Postural and Kinesthetic Awareness on Static Standing Balance in Stroke
Official title: Effects of Postural and Kinesthetic Awareness on Static Standing Balance and Planter Pressure by Using PoData Stabiliometric Plate in Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Stroke
Keywords: stroke
static balance
plantar pressure
postural and kinestetic awareness
PoData Stabiliometeric plate
Lead sponsor: University of Lahore
Sponsor class: OTHER
First posted: 2023-06-22
Enrollment: 62
Sex: ALL
Minimum age (years): 45
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this randomized controlled trial is to check the effects of postural and kinesthetic awareness on static standing balance in chronic stoke patients. Participants will be divided into two equal groups. One group will receive routine physical therapy while other group will receive postural and kinesthetic awareness in addition to routine physical therapy.

Detailed description: To determine effects of Postural and kinesthetic awareness on plantar pressure and static standing balance in chronic stroke patients. The study was conducted at the University of Lahore Teaching Hospital in the Department of Pediatric Physical Therapy \& Neuro Rehabilitation Center. Total 62 stroke patients with visual spatial neglect were enrolled in this study, patients were equally assigned into control and experimental group. Control group received routine physical therapy while experimental group received routine physical therapy and postural and kinesthetic awareness program. Static component of berg balance scale and PoData Stabiliometeric plate was used for measurement of balance and plantar pressure respectively

Eligibility criteria: Inclusion Criteria:

* Chronic stroke patient
* Both genders
* Age: 45-60 years
* 9 score or higher on static part of Berg Balance Scale
* Level 1 and 2 of Modified Ashworth Scale
* 24 or more score on Mini mental state scale

Exclusion Criteria:

* Patients with

  * Psychological diseases
  * Dementia
  * Orthopedic disorders
  * Any insufficiency that can influence balance

Primary outcomes:
measure: Static Component of Berg Balance Scale
timeFrame: 6 months
measure: PoData Stabiliometric Plate
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: The University of Lahore Teaching Hospital
state: Punjab
Study officials:
affiliation: The University of Lahore
name: Sameed Liaquat, MSPTN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02341495: Deferasirox, Cholecalciferol, and Azacitidine in the Treatment of Newly Diagnosed AML Patients Over 65
Official title: A Phase II Study Examining the Use of Deferasirox, Cholecalciferol, and Azacitidine in the Treatment of Newly Diagnosed Acute Myelogenous Leukemia (AML) in Elderly Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Acute Myeloid Leukemia
Keywords: Azacitidine
Vidaza
Deferasirox
Exjade
Cholecalciferol
Vitamin D
Lead sponsor: Loyola University
Sponsor class: OTHER
First posted: 2015-01-19
Enrollment: 4
Sex: ALL
Minimum age (years): 65
Maximum age (years): 89
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to find out if by giving a combination of 3 drugs the leukemia will go into complete remission (meaning the leukemia is completely gone), and to find out how long it stays away. The drugs used in this project are FDA approved and commercially available.

Detailed description: The majority of new cases of acute myeloid leukemia (AML) are diagnosed in patients older than 65 years of age. The median age of patients at time of diagnosis is 67 years. Standard therapies for AML often have significant toxicity and are poorly tolerated by this patient population. Treatment strategies for elderly patients with AML are limited. In those patients who do achieve complete remission, duration of remission tends to be short. Treatment at time of relapse is exceedingly difficult and outcomes are dismal. Thus, there is need for safer and more effective therapies for elderly patients with AML. This trial is a novel therapeutic combination of deferasirox (Exjade), cholecalciferol, and azacitidine in patients 65 years or older with newly diagnosed AML who are not fit for standard induction chemotherapy or hematopoietic stem-cell transplantation.

Eligibility criteria: Inclusion Criteria:

* 65 or older (must have reached 65th birthday)
* Morphologically confirmed diagnosis of AML, excluding AML-M3
* Must have a Zubrod performance status of 0-3

Exclusion Criteria:

* Patients with known HIV infection are excluded. If HIV infection is suspected based on clinical condition, testing may be performed at the discretion of treatment team, but is not mandated prior to enrollment.
* Patients with central nervous system involvement by AML are excluded
* Patients with history of an active cancer (except basal cell and squamous cell cancers of the skin) within the previous 2 years are excluded

Primary outcomes:
measure: Complete Remission Rate
timeFrame: up to 5 years
Secondary outcomes:
measure: Number of Patients With Adverse Events
timeFrame: up to 5 years
measure: Survival
timeFrame: up to 5 years
measure: Duration of Remission
timeFrame: up to 5 years
Other outcomes:
Locations:
city: Maywood
country: United States
facility: Loyola University Cardinal Bernardin Cancer Center
state: Illinois
Study officials:
affiliation: Faculty
name: Elizabeth Henry, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02723695: Perception and Equilibrium After Cochlear Implantation
Official title: Assessment of Perceptual and Postural Performances Following a Cochlear Implantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Deafness
Keywords: Cochlear implant
Perception
Posture
Quality of life
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
Collaborators: name: University of Lorraine
First posted: 2016-03-30
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The cochlear implant is an electrical hearing aid that restores the perception of surrounding sounds and speech intelligibility in profoundly deaf patients. During surgery, the labyrinthine break necessary for insertion into the cochlea of the implantable part may cause a malfunction of the vestibular system which can induce dizziness, balance and perception (of the gravitational vertical) disorders. Vestibular compensation and new sonic interactions could alter the balance control and the visual and postural spatial orientation perceptions.

The usual treatment includes the monitoring of the patient's quality of life, of the vestibular function and of hearing. This study adds an assessment of spatial orientation and of posture.


Eligibility criteria: Inclusion Criteria:

* Profound deaf patients who are scheduled for a cochlear implantation
* Patients gave their written informed consent
* Patients are affiliated to the french social welfare

Exclusion Criteria:

* Disorders from the motor and/or somesthetic systems (especially the lower limbs)
* Contraindications to the scheduled functional assessments

Primary outcomes:
measure: Change from baseline in postural perception of the gravitational vertical
timeFrame: One year
Secondary outcomes:
measure: Change from baseline in visual perception of the gravitational vertical
timeFrame: One year
measure: Change from baseline in dynamic balance control
timeFrame: One year
measure: Change from baseline in quiet standing within a specific sound environment
timeFrame: One year
measure: Change from baseline in vestibular function
timeFrame: One year
measure: Change from baseline in speech recognition
timeFrame: One year
measure: Change from baseline in quality of life
timeFrame: One year
measure: Change from baseline in dizziness
timeFrame: One year
Other outcomes:
Locations:
city: Nancy
country: France
facility: University Hospital of Nancy
Study officials:
affiliation: Central Hospital, Nancy, France
name: Cécile Parietti-Winkler, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02068495: Candesartan Cilexetil/Amlodipine Besilate Combination Tablets LD, HD Special Drug Use Surveillance "Hypertension: Long-Term Use"
Official title: Unisia Combination Tablets LD, HD Special Drug Use Surveillance "Hypertension: Long-Term Use"
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Keywords: Drug therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2014-02-21
Enrollment: 3409
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: Hypertension

Brief summary: The purpose of this survey is to investigate the safety and efficacy of long-term use of candesartan cilexetil/amlodipine besilate combination tablets (Unisia Combination Tablets) low dose (LD), high dose (HD) in participants with hypertension in the normal clinical setting.

Detailed description: This special drug use surveillance was designed to investigate the safety and efficacy of long-term use of candesartan cilexetil/amlodipine besilate combination tablets (Unisia Combination Tablets) in participants with hypertension in the routine clinical setting.

The usual adult dosage is one tablet (8 mg/2.5 mg or 8 mg/5 mg as candesartan cilexetil/amlodipine besilate) administered orally once daily.

Eligibility criteria: Inclusion Criteria:

1. Participants with hypertension

Exclusion Criteria:

1. Participants in whom Candesartan cilexetil/Amlodipine besilate is contraindicated \[Contraindications\]
2. Participants with a history of hypersensitivity to the ingredients of Candesartan cilexetil/Amlodipine besilate or any other dihydropyridine formulations
3. Women who are pregnant or of child-bearing potential

Primary outcomes:
measure: Number of Participants Who Experience at Least One Adverse Events
timeFrame: Up to 12 Months
measure: Number of Participants Who Experience at Least One Adverse Drug Reactions (ADRs)
timeFrame: Up to 12 Months
Secondary outcomes:
measure: Changes From Baseline in Systolic Blood Pressure (SBP) at Final Assessment
timeFrame: Baseline and final assessment (up to 12 Months)
measure: Changes From Baseline in Diastolic Blood Pressure (DBP) at Final Assessment
timeFrame: Baseline and final assessment (up to 12 Months)
measure: Changes From Baseline in Pulse Rate at Final Assessment
timeFrame: Baseline and final assessment (up to 12 Months)
measure: Percentage of Participants Who Meet Targeted Blood Pressure Level at Baseline and Final Assessment
timeFrame: Baseline and final assessment (up to 12 Months)
Other outcomes:
Locations:
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: