louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01054807: Non-Dispensing Evaluation of an Investigational Galyfilcon A Soft Contact Lens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Coles-Brennan Pty Ltd
First posted: 2010-01-22
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this investigation is to compare the fit characteristics and vision attributes of an investigational Galyfilcon A contact lens and an approved Galyfilcon A contact lens.


Eligibility criteria: Inclusion Criteria:

* Be of legal age (i.e., at least 18 years old)
* Sign a written informed consent
* Have contact lens distance sphere requirement in the range -1.00D to -6.00D
* Have spectacle astigmatism \<1.25D in each eye
* Currently wear ACUVUE® ADVANCE™ (for at least 6 months) with documentation of current prescription.
* Have normal eyes with no evidence of abnormality or disease.

Exclusion Criteria:

* Required concurrent ocular medication
* Any systemic illness which would contra-indicate lens wear or the medical treatment of which would affect vision or successful lens wear.
* Eye injury or surgery within eight weeks immediately prior to enrollment for this study.
* Abnormal lacrimal secretions
* Pre-existing ocular irritation that would preclude contact lens fitting.
* Keratoconus or other corneal irregularity.
* Pregnancy, lactating or planning a pregnancy at the time of enrolment.
* Participation in any concurrent clinical trial
* Known allergy to silver, silver ions, or silver containing compounds.

Primary outcomes:
measure: Comparison of Lens Fit Characteristics
timeFrame: Approximately 40 minutes of wear time
measure: Evaluation of Inter-Changeability
timeFrame: Approximately 40 minutes of wear time
measure: Determination of fit or Vision Differences
timeFrame: Approximately 40 minutes of wear time
Secondary outcomes:
Other outcomes:
Locations:
city: Hawthorn
country: Australia
facility: Coles-Brennan Pty Ltd
state: Victoria
Study officials:
affiliation: Coles-Brennan Pty Ltd
name: Noel Brennan, McOptom PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02725307: Non-invasive Peri- and Postoperative Monitoring of Femoral Artery Balloon Angioplasty
Official title: Non-invasive Peri- and Postoperative Monitoring of Femoral Artery Balloon Angioplasty
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
Collaborators: name: Tampere University of Technology
name: Tampere University
First posted: 2016-03-31
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Volunteer patients with diagnosed peripheral atherosclerotic disease referred for femoral artery percutaneous transluminal angioplastu.

Brief summary: This study evaluates a novel noninvasive method to dynamically monitor the effect of percutaneous transluminal angioplasty on arterial pulse wave

Detailed description: Patients with stenosis of superficial femoral artery referred for percutaneous transluminal angioplasty are monitored before, during and after the procedure and pulse wave analysis is conducted.

Eligibility criteria: Inclusion Criteria:

1. The patient has been clinically examined at policlinic of vascular surgery
2. The patient has undergone measurement of ankle-brachial index (ABI) and toe-brachial index (TBI) at policlinic of vascular surgery and exhibits abnormal ABI\<0.9 or ABI\>1.3
3. The patient is considered to have an indication for vascular procedure (critical limb ischemia, intermittent claudication)
4. The patient has been examined with magnetic resonance imaging (MRA)
5. The patient has been considered a candidate for superficial femoral artery percutaneous transluminal balloon angioplasty (PTA) and/or stenting

Exclusion Criteria:

1. Pacemaker
2. Measurement disturbs or risks the subject's treatment process

Withdrawal:

1. Emergency cases
2. By subject's denial
3. Inability to detect signals -

Primary outcomes:
measure: Pulse wave change from baseline during PTA
timeFrame: 1 hour
Secondary outcomes:
measure: Pulse wave characteristics after PTA
timeFrame: 30 days
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Tampere University Hospital
Study officials:
affiliation: Tampere University
name: Niku Oksala, Assoc. Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03465007: Steroids on Intra-dialytic Hypotension
Official title: Effects of Corticosteroids on Intra-dialytic Hypotension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dialysis Hypotension
Keywords: hemodialysis
cortisol
Hydrocortisone
Lead sponsor: University of Jordan
Sponsor class: OTHER
First posted: 2018-03-14
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Symptomatic hypotension during (or immediately following) hemodialysis complicates 5 to 30 percent of all dialysis treatments and is associated with increased morbidity and mortality. Kidney Disease Outcomes Quality Initiative (KDOQI) and European Best Practice Guidelines define intradialytic hypotension as the presence of a decrease in systolic blood pressure ≥20 mmHg or a decrease in mean arterial pressure by 10 mmHg, providing the decrease in blood pressure is associated with clinical events and need for nursing interventions. Common causes of intradialytic hypotension include excessive or rapid ultrafiltration, high blood flow during dialysis, CHF, taking the antihypertensive medications prior to HD, and others. One of the possible reasons that is surprisingly has not been approached worldwide for intra-dialytic hypotension could be more prevalent adrenal insufficiency in ESRD patients or a delay in the appropriate rise of endogenous serum cortisol given hemodialysis is considered by all means a stressful condition to the body. Investigators will assess first the prevalence of intradialytic hypotension at JUH dialysis unit. Investigators will screen patients who developed intradialytic hypotension for adrenal insufficiency by ordering random am cortisol. Then Investigators will give IV Hydrocortisone 100 mg prior to HD to patients who developed intra-dialytic hypotension and monitor their BP response during the HD treatments for 3 HD sessions (1 week, 3 HD sessions). After that, the same patients will receive 100 mg normal saline for 3 HD sessions. Both the administrator and the patient will be blinded for the interventions.


Eligibility criteria: Inclusion Criteria:

* Patients on hemodialysis who develop intra-dialytic hypotension.

Exclusion Criteria:

* Adrenal insufficiency

Primary outcomes:
measure: Intra-dialytic hypotension
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: School of Medicine
Study officials:
References:
citation: Alhawari HH, Alshelleh S, Alhawari HH, Alawwa IA, AlRyalat SA, Mesmar A, Ojjoh K, Alzoubi KH. Effect of Hydrocortisone on Intradialytic Hypotension: A Preliminary Investigational Study. Biomed Res Int. 2020 May 5;2020:4987547. doi: 10.1155/2020/4987547. eCollection 2020.
Clinical trial NCT05114707: Camrelizumab Plus Chemoradiotherapy for Patients With Locoregional Cancer of Nasal Cavity and Paranasal Sinuses
Official title: Camrelizumab Plus Chemoradiotherapy for Patients With Locoregional Cancer of Nasal Cavity and Paranasal Sinuses: a Phase II Multicenter Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Nasal Cavity Cancer
Paranasal Sinus Cancer
Camrelizumab
Induction Chemotherapy
Intensity Modulated Radiotherapy
Concurrent Chemotherapy
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2021-11-10
Enrollment: 57
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: Patients with locoregional cancer of nasal cavity and paranasal sinuses are candidate for this study. All the eligible patients receive three cycles of induction chemotherapy (docetaxel 60mg/m2+cisplatin 60mg/m2+5-FU2.5g/m2,civ48h, q3w) followed by concurrent two cycles of cisplatin (80mg/m2,q3w) with curative intensity modulated radiotherapy. Besides, camrelizumab (200mg) is administrated every three weeks for a total of 11 cycles since the first day of induction chemotherapy. We aim to evaluate the three years failure free survival of these patients by the combination of camrelizumab with curative radiotherapy and chemotherapy.


Eligibility criteria: Inclusion Criteria:

* histologically confirmed squamous cancer of nasal cavity and paranasal sinuses
* T4bN0-3M0 (AJCC8th) or unresectable lymph nodes or refusal of surgery
* KPS≥70
* NE≥ 1.5×10E9/L, HGB ≥ 100g/L and PLT ≥100×10E9/L
* ALT≤ 1.5 upper limit of normal (ULN), AST≤ 1.5ULN and bilirubin ≤ 1.5ULN
* creatinine clearance rate ≥ 60 ml/min (calculated by Cockcroft-Gault)

Exclusion Criteria:

* older than 65 or younger than 18
* HBsAg (+) and HBV DNA \>1×10E3 copiers /mL
* HCV (+)
* HIV (+)
* autoimmune diseases
* interstitial lung diseases
* had other cancers before

Primary outcomes:
measure: 3-year failure free survival
timeFrame: 3-year
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
References:
Clinical trial NCT00541307: GORE VIABAHN Endoprosthesis With Heparin Bioactive Surface in the Treatment of SFA Obstructive Disease (VIPER)
Official title: Post Marketing Study of the GORE VIABAHN Endoprosthesis With Heparin Bioactive Surface in the Treatment of Superficial Femoral Artery Obstructive Disease (VIPER)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Vascular Diseases
Keywords: Peripheral Arterial Disease
Peripheral Vascular Disease
Lead sponsor: W.L.Gore & Associates
Sponsor class: INDUSTRY
First posted: 2007-10-10
Enrollment: 119
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 objective of the study is collect data on the GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface in the treatment of chronic Superficial Femoral Artery disease. Device patency at 12 months is the primary endpoint.


Eligibility criteria: Inclusion Criteria:\>

* lifestyle limiting claudication, rest pain or minor tissue loss\>
* ABI (ankle-brachial index) \< 0.9 or TBI (toe-brachial index) \< 0.5 if ABI is \>0.9
* Stenosis (\>50%) or occlusion of native SFA (superficial femoral artery) \>5cm
* Orifice and 1 cm of SFA are patent
* Popliteal artery is patent at the intercondylar fossa of the femur to the trifurcation
* At least 1 patent run off vessel
* Guidewire and deliver system successfully traversed the lesion

Exclusion Criteria:\>

* Untreated flow-limiting aortoiliac occlusive disease
* Any previous stenting or surgery in the target vessel
* Femoral or popliteal aneurysm of target vessel
* No patent tibial arteries
* Prior ipsilateral femoral artery bypass
* Major distal amputation (above the transmetatarsal) in either limb
* Patients with known sensitivity to Heparin

Primary outcomes:
measure: Primary Patency at 12 Months
timeFrame: 12 months
Secondary outcomes:
measure: Proportion of Subjects Who Experience Major Device-related Adverse Events Within the First 30 Days
timeFrame: 30 days
measure: Primary Assisted Patency
timeFrame: 12 months
measure: Secondary Patency
timeFrame: 12 months
measure: Device-related Major Adverse Events at 12 Months
timeFrame: 12 months
Other outcomes:
Locations:
city: Oceanside
country: United States
facility: Tri-City Medical Center
state: California
city: Chicago
country: United States
facility: Mercy Hospital and Medical Center
state: Illinois
city: Columbia
country: United States
facility: Columbia Surgical Associates
state: Missouri
city: Dallas
country: United States
facility: Baylor University Medical Center
state: Texas
city: Milwaukee
country: United States
facility: St. Luke's Medical Center
state: Wisconsin
Study officials:
affiliation: North County Radiology Medial Group Inc.
name: Richard Saxon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02878707: The Neuroprotective Effects of Dexmedetomidine During Brain Surgery
Official title: The Neuroprotective Effects of Dexmedetomidine During Brain Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Tumor
Cerebrovascular Disorders
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2016-08-25
Enrollment: 160
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Dexmedetomidine (DEX) is a Alpha-2 specific agonist, is a common ICU sedation medication. In brain tumor resection craniotomy, it is proven to be effective in improving postoperative hypertension and tachycardia, mitigates postoperative nausea and vomiting and relives postoperative pain. In addition, many animal experiments show that DEX inhibits the proapoptosis in the mitochondrial in vivo and therefore avoids neuronal injury. It is also reported to be neuroprotective to isoflurane-induced neurotoxicity and to improve cerebral focal ischemic region (penumbra). However, the neuroprotective effects were never investigated clinically in patients undergoing brain tumor resection surgery.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing elective craniotomy for supratentorial brain tumor resection or cerebral vascular surgery
* age between 20 to 80 yr

Exclusion Criteria:

* Fever, elevated white blood cell or C-reactive protein
* Impaired liver function, eg. AST or ALT \>100; liver cirrhosis \> Child B class
* Impaired renal function, cGFR\< 60 ml/min/1.73 m2
* Cardiac dysfunction, such as heart failure \> NYHA class II

Primary outcomes:
measure: Number of participants with postoperative neurological complications
timeFrame: during postoperative period of hospital admission, approximately 10 days by estimation
Secondary outcomes:
measure: Number of participants with postoperative delirium
timeFrame: during postoperative period of hospital admission, approximately 10 days by estimation
measure: Serum biomarkers changes
timeFrame: Between preoperative baseline and postoperative day one.
measure: Intraoperative haemodynamic profile
timeFrame: during intraoperative perioid, approximately 4-6 hours by estimation
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: Anesthesiology Department, National Taiwan University Hospital
name: Chun-Yu Wu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chen PH, Tsuang FY, Lee CT, Yeh YC, Cheng HL, Lee TS, Chang YW, Cheng YJ, Wu CY. Neuroprotective effects of intraoperative dexmedetomidine versus saline infusion combined with goal-directed haemodynamic therapy for patients undergoing cranial surgery: A randomised controlled trial. Eur J Anaesthesiol. 2021 Dec 1;38(12):1262-1271. doi: 10.1097/EJA.0000000000001532.
Clinical trial NCT03626207: Development of Visual Function Evaluation Method (2)
Official title: Calibration of Visual Function Evaluation Tests in Patients With Severe Vision Loss
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Retinitis Pigmentosa
Keywords: Retinitis pigmentosa
Visual function evaluation
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2018-08-10
Enrollment: 8
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Retinitis pigmentosa

Brief summary: The objective of this study is to develop the comprehensive visual function evaluation method in severe visually impaired patient.


Eligibility criteria: Inclusion Criteria:

* Subjects with severe visual disturbance (count-fingers or worse vision for severe eyes) at the time of obtaining the consent and at screening

Exclusion Criteria:

* Subjects should not have participated in any other clinical trial or clinical study involving visual function evaluation within 6 months
* History of surgery, past history, and complications (cardiac/ hepatic/ renal/ respiratory/ hematological diseases, optic nerve diseases causing marked loss of visual field, and uveitis etc.) that potentially affect evaluation and safety of the study
* Pregnant women
* Subjects who are judged that continuation of the study is difficult during the study period
* Subjects who are employed by the company sponsoring this study, an organization or institution related to this study

Primary outcomes:
measure: Slit-lamp-microscopy
timeFrame: Up to 3 months
measure: Optical Coherence Tomography (OCT) test
timeFrame: Day 1
measure: Early Treatment Diabetic Retinopathy Study (ETDRS)
timeFrame: Up to 3 months
measure: The 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25)
timeFrame: Up to 3 months
measure: The 11-item National Eye Institute Visual Function Questionnaire (NEI VFQ-11)
timeFrame: Up to 3 months
measure: Nottingham Adjustment Scale Japanese Version (NAS-J)
timeFrame: Up to 3 months
measure: Daily living task dependent on vision (DLTV) questionnaire
timeFrame: Up to 3 months
measure: Table test
timeFrame: Up to 3 months
measure: Monitor test
timeFrame: Up to 3 months
measure: Pupillary function test
timeFrame: Up to 3 months
measure: Full field stimulus threshold testing (FST)
timeFrame: Up to 3 months
measure: White flash visual evoked potential (VEP) test
timeFrame: Up to 3 months
measure: Color flash VEP test
timeFrame: Up to 3 months
measure: Electrically evoked response (EER) test
timeFrame: Up to 3 months
measure: White flash Electroretinography (ERG) test
timeFrame: Day 1
measure: Multifocal ERG test
timeFrame: Up to 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kobe
country: Japan
facility: Site JP00001
state: Hyogo
Study officials:
affiliation: Astellas Pharma Inc
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT05078788: Holmium Laser Uretherotomy in Combination With Intralesional Steroids in Bulbar Uretheral Stricture
Official title: Efficacy of Holmium Laser Uretherotomy in Combination With Intralesional Steroids in the Treatment of Bulbar Uretheral Stricture
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urethral Stricture
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2021-10-15
Enrollment: 124
Sex: MALE
Minimum age (years): 26
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: the purpose is to evaluate the outcome of visual internal uretherotomy with Holmium laser along with intralesional steroid injection.

Detailed description: In this study, the investigator evaluates the efficacy of Holmium laser in combination with intra lesional steroid injection in the treatment of bulbar urethral strictures

Eligibility criteria: Inclusion Criteria:

1. Presence of obstructive symptoms,
2. Short segment strictures (stricture length \<2 cm) as evident on radiological studies, i.e. retrograde urethrography and micturating cystourethrography.
3. Peak flow rate on uroflowmetry less than 15 ml/s

Exclusion Criteria:

1. Complete obliteration of lumen of urethra on urethroscopy,
2. Balanitis Xerotica Obliterans,
3. Age less than 18 years,
4. Multiple strictures,
5. Active urinary tract infection,
6. Recurrent Strictures.
7. Prior internal uretherotomy
8. Prior urethroplasty
9. Pan-anterior urethral strictures
10. Posterior stenosis
11. Those who lost to follow up

Primary outcomes:
measure: the maximum flow rate (Qmax) is >15 ml/s at 3 and 6 months after procedure
timeFrame: 3 and 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams university
Study officials:
References:
Clinical trial NCT02642588: Effect of a Commercially Available Carbohydrate Rich Gel on Maternal Fatigue: A Randomized Controlled Trial
Official title: Effect of a Commercially Available Carbohydrate Rich Gel on Maternal Fatigue: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Effect of Carbohydrate Ingestion During Active Labor
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
Collaborators: name: Melissa March
name: Alison Bauer
name: Gaetan Pettigrew
name: Daisy Hassani
name: Celina Cunanan
First posted: 2015-12-30
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Women in active labor will be given energy gel at 45-60 minute intervals and their fatigue level will be compared to women receiving usual practice care i.e. clear liquids only.


Eligibility criteria: Inclusion Criteria:

* Patients must be 18 years or older as well as willing and able to provide informed consent
* Patients with BMI \< 35 kg/m\^2
* Gestational age \>37 weeks

Exclusion Criteria:

* - Patients younger than 18 years,
* Patients unable or unwilling to provide informed consent,
* Patients who are illiterate,
* Patients who are non-English speaking or reading,
* Patients who are University Hospital employees,
* Patients undergoing induction of labor for maternal or fetal indications other than elective induction after 39 weeks or induction for post-term pregnancy
* Multi-fetal gestations (\>1 intrauterine pregnancy),
* Patients with a history of GI disorders such as hyperemesis gravidarum, inflammatory bowel disease or irritable bowel syndrome
* Patients with an increased risk of aspiration such as BMI \>35 kg/m\^2, severe GERD, gastroesophageal motility disorders,
* Patients with acute or chronic platelet dysfunction (e.g.: idiopathic thrombocytopenic purpura, HELLP syndrome) which may necessitate need for general anesthetic for Cesarean delivery
* Patients with history of peptic ulcer disease,
* Patients who have a contraindication to epidural placement and would require general anesthestetic in event of Cesarean delivery
* Patients with suspected or proven placenta accreta, increta or percreta,
* Patients with excessive nausea or vomiting during labor
* Patients with a history of food allergies or allergies to specific components found in the energy gel.

Primary outcomes:
measure: Fatigue
timeFrame: every 2 hours until delivery
measure: duration of labor
timeFrame: from start of active phase until delivery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: