louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02934282: HBOC-201 Expanded Access Protocol for Life-threatening Anemia for Whom Allogeneic Blood Transfusion is Not an Option
Official title: Expanded Access Protocol Using HBOC-201
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Anemia
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2016-10-14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT

Brief summary: The purpose of this protocol is to provide treatment with HBOC-201 to patients with life-threatening anemia for whom blood is not an option. Such patients may also be referred to in this document as patients who refuse blood transfusion (PWRBT). Other patients who potentially may require HBOC-201 treatment include those with red blood cell alloantibodies for whom immunologically compatible red blood cell units cannot be found, although these patients are less common than PWRBT.

Detailed description: This is an open label intermediate-size patient population expanded access IND protocol.

Due to our experience with management of severely anemic patients for whom blood is not an option, we anticipate encountering future patients with life-threatening anemia for whom blood is not an option. Blood is not an option in the following circumstances:

* refusal of transfusion
* lack of compatible red blood cells due to alloimmunity

All patients with life-threatening anemia for whom blood is not an option will be treated as per the standard procedure. If those measures are not successful and the life-threatening anemia persists, then at the investigator's discretion treatment with HBOC-201 will then be considered.

Eligibility criteria: Inclusion Criteria:

1. Patients ≥ 18 years of age
2. Critically ill patients with hemoglobin \< 5 g/dL (or 6-7 g/dL with significant active bleeding), and physiologic evidence of critical ischemia, for example: elevated troponins, altered mental status, acute renal failure, lactic acidosis or evidence of central nervous system acute deficits
3. Patients or their Legally Authorized Representative who are able and willing to provide informed consent
4. Blood is not an option due to:

   * refusal of transfusion
   * lack of compatible red blood cells

Exclusion Criteria:

1. Patients with known hypersensitivity or allergy to beef products
2. Patients with pre-existing uncontrolled hypertension, heart failure, renal failure, circulatory hypervolemia or systemic mastocytosis\*
3. Patients who are eligible for blood transfusions
4. Patients who are \> 80 years old\*
5. Pregnant
6. Lactating

   * on a case by case and quality of life determination

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: Jackson Memorial Hospital
state: Florida
Study officials:
affiliation: University of Miami
name: Mauricio Lynn
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01618682: Cortical Organization in Allogeneic Transplants or Heterotopic Hand Replants
Official title: Cortical Organization in Allogeneic Transplants or Heterotopic Hand Replants
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hand Transplant
Hand Replant
Keywords: hand transplant
hand replant
Lead sponsor: Christine M. Kleinert Institute for Hand and Microsurgery
Sponsor class: OTHER
Collaborators: name: University of Missouri-Columbia
First posted: 2012-06-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be patients who have undergone hand transplant or replant procedures at Kleinert Kutz and Associates or who are on the hand transplant registry.

Brief summary: The investigators hope to gain insights into the functional organization of the human cerebral cortex in response to upper limb amputation and surgical interventions including hand replantation and hand transplantation.


Eligibility criteria: Inclusion Criteria:

* between 18-70 yrs old
* undergone successful allogeneic transplantation of one or both hands OR undergone successful reattachment of one or both hands OR will have experienced surgical repair of one or more severed nerves (ulnar, medial, radial, digital in the upper limb
* must speak English

Exclusion Criteria:

* younger than 18 years or older than 70 years
* not undergone a replant or transplant

Primary outcomes:
measure: Ultrasound Biomicroscopy
timeFrame: Up to 12 months
Secondary outcomes:
measure: Grip Strength
timeFrame: Up to 12 months
measure: Pinch Strength
timeFrame: Up to 12 months
measure: DASH Questionnaire
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Christine M. Kleinert Insitute of Hand and Microsurgery
state: Kentucky
Study officials:
affiliation: Christine M. Kleinert Institute for Hand and Microsurgery
name: Christina L Kaufman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00206882: The Sun Protection Effect and Efficacy in Treatment of Sunburn Using Topical Corticosteroids.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sunburn
Keywords: sunburn
corticosteroids
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
First posted: 2005-09-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the sun protection effect and efficacy in treatment of sunburn using topical corticosteroids in a randomised controlled and investigator blinded trial.


Eligibility criteria: Inclusion Criteria:

* 18 years or older, healthy, fair skinned (skin type I-III)

Exclusion Criteria:

* Pregnant or lactating women.In treatment with corticosteroids.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Bispebjerg Hospital
state: Copenhagen NV
Study officials:
affiliation: Bispebjerg Hospital
name: Hans Christian Wulf, M.D., Dr.Sc.
role: STUDY_DIRECTOR
References:
citation: Faurschou A, Wulf HC. Topical corticosteroids in the treatment of acute sunburn: a randomized, double-blind clinical trial. Arch Dermatol. 2008 May;144(5):620-4. doi: 10.1001/archderm.144.5.620.
Clinical trial NCT01985282: Feasibility Clinical Study of NLA Tool
Official title: Evaluate the Feasibility of the NLA Tool, a Combined Assessment of Nutritional and Physical Functional Status, to Provide Personalized Advice for the Independence and Mobility of Elderly.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy Elder People
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2013-11-15
Enrollment: 250
Sex: ALL
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Free-living or institutionalized elderly (65-90years)

Brief summary: The study is to evaluate the feasibility of the NLA tool, a combined assessment of nutritional and physical functional status, to provide personalized advice for the independence and mobility of elderly.


Eligibility criteria: Inclusion Criteria:

1. aged between 65 and 90 years,
2. able to walk with or without walking aid,
3. having obtained the subject's written informed consent
4. free of cognitive impairment,

Exclusion Criteria:

1. restricted by a doctor to exercise.
2. unable to carry out performance tests and questionnaires correctly,
3. lower or upper extremity surgery or fracture in the last 3 months
4. having history of neurological disease (e.g., Parkinson disease, stroke) with residual impairment

Primary outcomes:
measure: NLA Feasibility
timeFrame: Day 1 of Study
measure: The Segmentation of Target Population
timeFrame: Day 1 of Study
Secondary outcomes:
Other outcomes:
Locations:
city: Tsukuba
country: Japan
facility: Graduate School of Comprehensive Human Sciences, Tsukuba University
state: Ibaraki
Study officials:
affiliation: Graduate School of Comprehensive Human Sciences, Tsukuba University
name: Kiyoji Tanaka, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03876782: Level of Agreement of Intraocular Lens Power Measurements Between IOLMaster and Verion
Official title: Level of Agreement of Intraocular Lens Power Measurements Between IOLMaster and Verion
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cataract
Keywords: cataract surgery
Verion Image-Guided System
IOLMaster
IOL calculation
keratometry
corneal power
toric IOL
Lead sponsor: Democritus University of Thrace
Sponsor class: OTHER
First posted: 2019-03-15
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Cataract patient that visit the Cataract Outpatients Service of the University Hospital of Alecxnadroupolis

Brief summary: Primary objective of this study is to evaluate the level of agreement of two keratometry modules, the IOLMaster and the Verion Reference Unit, in terms of keratometric values and IOL power calculation.

Detailed description: Participants were enrolled from the Cataract \& Presbyopia Service of the University General Hospital of Alexandroupolis in a consecutive-if-eligible basis. Apart from keratometric values, IOL power calculations will be compared for 8 IOL models (Acrysof SN60WF, SN60AT, SN6ATx, TFNT00, TFNTx0, SV25T0, SV25Tx and Tecnis ZCB00) using 4 formulas (SRK/T, Holladay 1, Hoffer Q and Haigis).

Eligibility criteria: Inclusion Criteria:

* Senile Cataract

Exclusion Criteria:

* Former incisional surgery,
* Corneal diseases,
* Dry-eye-Disease,
* Glaucoma drops,
* Inability to obtain accurate measurements.

Primary outcomes:
measure: IOL Power Calculation
timeFrame: 1 day prior to surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandroupolis
country: Greece
facility: University Hospital of Alexandroupolis
state: Evros
Study officials:
affiliation: Associate Professor
name: Georgios Labiris, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT06653582: Effect of Postural Reeducation Versus Pelvic Floor Muscle Training on Stress Urinary Incontinence
Official title: Effect of Postural Reeducation Versus Pelvic Floor Muscle Training on Stress Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Urinary Incontinence
Lead sponsor: Misr University for Science and Technology
Sponsor class: OTHER
First posted: 2024-10-22
Enrollment: 50
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the effects of postural reeducation compared to pelvic floor muscle training on urinary incontinence (UI) symptoms, the impact of UI, and quality of life (QoL) in women experiencing stress urinary incontinence (SUI)

Detailed description: The study is designed as a randomized- controlled trial. It will be carried out on women suffering from stress urinary incontinence referred after urology consultations to the Physiotherapy Clinic in Soad Kafafy hospital.

UI, particularly SUI, affects up to 28% of the population and occurs during activities like coughing or sneezing due to inadequate urethral closure pressure. The pelvic floor muscles play a critical role in supporting pelvic organs and maintaining continence. Pelvic floor dysfunction is a significant contributor to SUI. Postural dysfunction can increase mechanical stress and lead to pelvic floor dysfunction. Postural re-education techniques aim to correct imbalances and improve pelvic floor muscle activity, potentially alleviating SUI symptoms by restoring muscle efficiency and enhancing continence.

Eligibility criteria: Inclusion Criteria:

* Fifty females with stress urinary incontinence.
* Age of 30-40 years.
* Body mass index (BMI) \> 30 kg/m2

Exclusion Criteria:

* Genital prolapse grade 3 or 4 based on Pelvic Organ Prolapse Quantification Classification (POP-Q).
* Overactive bladder (OAB)
* Functional impairment (Barthel scale \<85 points).
* Neurological or cognitive impairment (mini mental examination \<24 points).
* Any other type of urinary incontinence.
* Pregnancy.
* History of spinal, hip, knee or foot surgery, pelvic and abdominal surgery (including cesarean section)
* Smoking, chronic cough, history of respiratory diseases, osteoporosis (self-reported).

Primary outcomes:
measure: Urinary incontinence (UI) symptoms
timeFrame: 12 weeks
measure: Urinary incontinence (UI) impact
timeFrame: 12 weeks
Secondary outcomes:
measure: Urinary incontinence-Quality of life (UI-QoL)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of physical therapy, MUST University
Study officials:
affiliation: Lecturer, MUST university
name: Sally Mohamed Saeed, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lecturer, Al Hayah university
name: Malak Adel Elmahdy, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02709382: A Single-dose Study to Investigate the Pharmacokinetics of Intravenous FEP-TAZ in Patients With Renal Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Renal Impairment
Lead sponsor: Wockhardt
Sponsor class: INDUSTRY
Collaborators: name: Clinartis
First posted: 2016-03-16
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: This is a Phase 1, open label, single-dose, pharmacokinetic study to be conducted in male and female subjects with normal and impaired renal function. The study will be composed of five groups of patients with mild (6 patients), moderate (6 patients), severe (6 patients) renal impairment, end stage renal disease patients on hemodialysis (6 patients) and their respective matched controls in 1:1 ratio (24 healthy subjects with normal renal function).


Eligibility criteria: Inclusion Criteria:

-Patients with renal impairment: mild, moderate, severe and patients on hemodialysis) that has been stable OR

* Healthy Subjects:
* Have normal renal function
* No evidence of any disease or condition that may affect pharmacokinetics of FEP-TAZ.

Exclusion Criteria:

* Evidence of hepatorenal or nephritic syndrome
* Any clinically significant abnormal findings on medical history, physical examination,or clinical laboratory tests (other than those associated with controlled diabetes,hypertension, hypercholesterolemia, dyslipidemia, or renal impairment or related or causative diseases)

Primary outcomes:
measure: plasma concentrations (Cmax)
timeFrame: 48 hrs
measure: Tmax The elimination half-life (t1/2),
timeFrame: 48 hrs
Secondary outcomes:
measure: Number of Participants With Abnormal Laboratory Values
timeFrame: 14 days
measure: Number of Participants With Adverse Events
timeFrame: 14 days
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami,Division of Clinical Pharmacology
state: Florida
Study officials:
References:
citation: Preston RA, Mamikonyan G, Mastim M, Garg D, Kemper CJ, Xu A, Yeole R, Chavan R, Friedland HD, Bhatia A. Single-Center Investigation of the Pharmacokinetics of WCK 4282 (Cefepime-Tazobactam Combination) in Renal Impairment. Antimicrob Agents Chemother. 2019 Sep 23;63(10):e00873-19. doi: 10.1128/AAC.00873-19. Print 2019 Oct.
Clinical trial NCT06294782: PrOsPective Cohort Study for STereotactic Arhythmia Radioablation (STAR) of Refractory Ventricular Tachycardia
Official title: PrOsPective Cohort Study for STereotactic Arhythmia Radioablation (STAR) of Refractory Ventricular Tachycardia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Refractory Ventricular Tachycardia
Lead sponsor: University of Turin, Italy
Sponsor class: OTHER
Collaborators: name: Azienda USL Reggio Emilia - IRCCS
name: IRCCS Sacro Cuore Don Calabria di Negrar
name: Fondazione IRCCS Policlinico San Matteo di Pavia
First posted: 2024-03-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a multicenter, interventional study. The study will enroll patients that fulfill the inclusion criteria over a 33-month period. Considering the small number of patients who will meet the study criteria, it is also possible to include retrospective patients who already underwent STAR (for instance, as part of a compassionate program) if they meet all the inclusion and exclusion criteria as well as the treatment planning standardized requirements and sign their consent to this trial. All patients prospectively enrolled will undergo a flow of investigations following a standardized approach. ICD programming will be standardized.


Eligibility criteria: Inclusion Criteria:

1. Structural heart disease (SHD) defined as left ventricular dysfunction (LVEF \< 55%), or right ventricular dysfunction (FAC \<35%) or presence of ventricular scar, pathological hypertrophy, wall bulging or inflammatory conditions.
2. Optimized medical treatment for the underlying SHD
3. ICD or CRT-D recipient
4. ≥ 1 episodes of sustained or treated (with either anti-tachycardia pacing or shock, internal or external) monomorphic VT (MMVT) resistant to at least one invasive VT ablation attempt, unless contraindicated or deemed at high risk. Reason for lack of ablation must be specified

Exclusion Criteria:

1. Age \< 18 or \> 85 years.
2. Inability to provide informed consent.
3. Acute myocardial infarction or recent primary coronary intervention or cardiac surgery (\<3 months)
4. Primary electrical disease (e.g. long QT syndrome, short QT syndrome, catecholaminergic polymorphic ventricular tachycardia, Brugada syndrome).
5. Reversible and/or treatable cause of VT (e.g., drug-induced or intoxication)
6. ICD electrode malfunction or ICD readings outside reference range
7. Pregnancy or breast feeding
8. Patients with polymorphic VT/VF

Primary outcomes:
measure: VT storm and incessant VT
timeFrame: 6 months
measure: adverse events
timeFrame: 33 months
Secondary outcomes:
Other outcomes:
Locations:
city: Turin
country: Italy
facility: University of Turin
Study officials:
References:
Clinical trial NCT00416182: Nasally Delivered Pulmozyme for Sinusitis in Cystic Fibrosis
Official title: The Use of Nasally Delivered Pulmozyme in the Treatment of Sinusitis in Cystic Fibrosis Patients: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Sinusitis
Cystic Fibrosis
Keywords: Cystic fibrosis
chronic sinusitis
mucolytic
Lead sponsor: University of Vermont
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
First posted: 2006-12-27
Enrollment: 16
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Chronic sinusitis is a frequent complication in cystic fibrosis. The aim of this study is to determine whether Pulmozyme(dornase alfa) would maintain sinus health (compared to placebo) in patients with cystic fibrosis who have recently undergone sinus surgery.

Detailed description: AIM: To evaluate the effectiveness of Pulmozyme(dornase alfa) in decreasing post-operative sinusitis symptoms in patients with cystic fibrosis (CF)

PROCEDURES: 20 patients with CF will be randomized to receive either Pulmozyme or placebo via nasal inhalation daily for 12 months. Consent will be obtained following surgery and treatment will begin 1 week post-operatively.

Monitoring will include examination and recording of adverse effects and follow up weekly for one month and then at 2.5, 6, 9 and 12 months.

Outcome measures will include ciliary function testing, pulmonary function testing, sinus questionnaires and CT scan.

Eligibility criteria: Inclusion Criteria:

* Clinical and laboratory diagnosis of cystic fibrosis
* Age greater than or equal to 5 years
* Forced expiratory volume in 1 second (FEV1) greater than or equal to 40% predicted
* Sinus surgery within one week of enrollment

Exclusion Criteria:

* Pregnancy
* Intolerance of orally inhaled Pulmozyme (dornase alfa)

Primary outcomes:
measure: Computed Tomography Evidence of Less Sinus Disease
timeFrame: baseline and 1 year
measure: Improvement in Appearance of Nasal Passages/Sinuses
timeFrame: baseline and 1 year
Secondary outcomes:
measure: Chronic Sinusitis Survey Score
timeFrame: baseline and 1 year
measure: Pulmonary Function
timeFrame: baseline and 1 year
Other outcomes:
Locations:
city: Burlington
country: United States
facility: Fletcher Allen Health Care
state: Vermont
Study officials:
affiliation: University of Vermont
name: Thomas Lahiri, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Vermont Medical Center
name: Sandra Diehl, MS
role: STUDY_DIRECTOR
References:
citation: Lahiri T, Herrington H, Diehl S, Landrigan G. The effect of intranasal dornase alfa on chronic sinusitis in patients with cystic fibrosis: a pilot study. Pediatr Pulmonol S35:354, 2012.
citation: Yang C, Montgomery M. Dornase alfa for cystic fibrosis. Cochrane Database Syst Rev. 2021 Mar 18;3(3):CD001127. doi: 10.1002/14651858.CD001127.pub5.