louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01922154: Intravitreous Ranibizumab as Adjunctive Treatment for Trabeculectomy in Neovascular Glaucoma
Official title: Intravitreous Ranibizumab as Adjunctive Treatment for Trabeculectomy in Neovascular Glaucoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Glaucoma, Neovascular
Keywords: Angiogenesis inhibitors
Neovascular
Intraocular pressure
Retinal Vein Occlusion
Vascular Endothelial Growth Factor
Lead sponsor: Siriraj Hospital
Sponsor class: OTHER
First posted: 2013-08-14
Enrollment: 15
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: To evaluate the effects of intravitreal ranibizumab (IVR) as adjunctive treatment for trabeculectomy with mitomycin C (TMC) in neovascular glaucoma (NVG).

Detailed description: This is a prospective study of 15 consecutive eyes from 14 patients (One patients had NVG in both eyes at presentation.) with NVG presented at the Department of Ophthalmology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand between December 2008 and December 2009. Each eye received IVR (0.5 mg/0.05 ml) 1 week before TMC. Trabeculectomy was performed with fornix-based conjunctival flap method.

Eligibility criteria: Inclusion Criteria:

* Consecutive patients with neovascular glaucoma
* Age more than 80 year old
* Provide written informed consent

Exclusion Criteria:

* Un-cooperated patients

Primary outcomes:
measure: The change of intraocular pressure (IOP)
timeFrame: Change of IOP between before trabeculectomy and at last visit
Secondary outcomes:
measure: The safety of intravitreal ranibizumab (IVR)
timeFrame: On the day patient receives IVR
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Naris Kitnarong
Study officials:
affiliation: Mahidol University
name: Naris Kitnarong, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kitnarong N, Chindasub P, Metheetrairut A. Surgical outcome of intravitreal bevacizumab and filtration surgery in neovascular glaucoma. Adv Ther. 2008 May;25(5):438-43. doi: 10.1007/s12325-008-0047-5.
citation: Alkawas AA, Shahien EA, Hussein AM. Management of neovascular glaucoma with panretinal photocoagulation, intravitreal bevacizumab, and subsequent trabeculectomy with mitomycin C. J Glaucoma. 2010 Dec;19(9):622-6. doi: 10.1097/IJG.0b013e3181ccb794.
citation: Dunavoelgyi R, Zehetmayer M, Simader C, Schmidt-Erfurth U. Rapid improvement of radiation-induced neovascular glaucoma and exudative retinal detachment after a single intravitreal ranibizumab injection. Clin Exp Ophthalmol. 2007 Dec;35(9):878-80. doi: 10.1111/j.1442-9071.2007.01632.x.
Clinical trial NCT00879554: A Safety And Pharmacokinetic Study With CVX-045 In Patients With Advanced Solid Tumors
Official title: A Multicenter, Open-Label, 2-Stage, Phase 1, Clinical Safety, Pharmacokinetic, And Pharmacodynamic Study Of CVX-045, A Thrombospondin-1 Mimetic, Anti-Angiogenic Agent, In Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Solid Tumors
Neoplasms
Carcinoma
Cancer
Malignancy
Keywords: Phase 1
Solid Tumors
CVX-045
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-04-10
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to determine safety and tolerability of CVX-045 in patients with advanced solid tumors.


Eligibility criteria: Inclusion Criteria:

* Confirmed advanced solid tumors unresponsive to currently available therapies, or for which there is no standard therapy.
* Adequate coagulation, liver and renal function.
* Candidate for DCE-MRI evaluation.
* ECOG (Eastern Cooperative Oncology Group) performance status 0 or 1.

Exclusion Criteria:

* Evidence of bleeding problems.
* Uncontrolled hypertension.
* Certain gastrointestinal problems including fistula and abscess.
* Patients with primary brain cancer.

Primary outcomes:
measure: To determine safety and tolerability of CVX-045 as weekly intravenous (IV) infusions in adult patients with advanced solid tumors
timeFrame: Throughout duration of study
measure: To identify and characterize CVX-045-related adverse events (AEs)
timeFrame: Throughout duration of study
Secondary outcomes:
measure: To evaluate the plasma pharmacokinetics (PK) of CVX-045
timeFrame: Days 1, 4, 8, 15, 29
measure: To determine a recommended Phase 2 dose of CVX-045
timeFrame: End of study
measure: To evaluate the potential for immunogenicity of CVX-045
timeFrame: Days 1, 15, 1st day of every subsequent cycle, EOS, 30 Day FU
measure: To document any preliminary evidence of antitumor activity
timeFrame: Every 8 weeks
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Santa Monica,
country: United States
facility: Pfizer Investigational Site
state: California
city: Philadelphia
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT03855254: Psychological Context Effects
Official title: Psychological Context Effects of Participant Expectation on Pain Pressure Thresholds Following Cervicothoracic HVLA Thrust Manipulation: A Double Blind, Crossover, Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Positive Communication (Primary)
Negative Communication
Control Condition
Keywords: Contextual effects
Lead sponsor: Swansea University
Sponsor class: OTHER
First posted: 2019-02-26
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study explores how contextual effects in the fore of positive and negative communication can affect the effect of an osteopathic technique on pain pressure thresholds.


Eligibility criteria: Inclusion Criteria:

* Health volunteers with no forms of existing pain.

Exclusion Criteria:

* Participants with existing pain.

Primary outcomes:
measure: Pain pressure threshold
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Swansea
country: United Kingdom
facility: Swansea University
state: Wales
Study officials:
References:
Clinical trial NCT06112054: Impedance Sensor Evaluated in Peripheral Artery Disease for Tissue Detection
Official title: Impedance Sensor Evaluated in Peripheral Artery Disease for Tissue Detection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Vascular Disease
Keywords: PAD
Lead sponsor: Sensome
Sponsor class: INDUSTRY
First posted: 2023-11-01
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single center, single group, non comparative study
Primary purpose: OTHER

Brief summary: The objective of the study is to evaluate the feasibility of the CSGS sensor to differentiate tissues involved in Peripheral Artery Disease (PAD).

Detailed description: The objective of the study is to evaluate the feasibility of the CSGS sensor to differentiate tissues involved in Peripheral Artery Disease (PAD)

Previously the CSGS was used in a clinical study in stroke patients (The Clot Out Study) to direct a catheter through blood vessels and to measure electrophysiological parameters in the blood vessels during procedures.

In the current study however, a commercially available CE marked guidewire will be used to direct a catheter through blood vessels while the Clotild® Smart Guidewire System will only be used to perform electrophysiological measurements in the blood vessels during peripheral endovascular procedures. It is thus designed for use as an adjunct to conventional angiographic procedures.

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Subjects with acute and chronic occlusions in the arteries of the lower limbs
* Patients eligible for endovascular interventional procedures
* Written Informed Consent to participate in the study.

Exclusion Criteria:

* Target Vessel Aneurysm
* Target vessel diameter \<2mm
* Lesions starting at the Common Iliac Artery
* Any subject that is, according to the discretion of the investigator, not eligible for study participation
* Known lactating or confirmation of positive pregnancy test according to site specific standard of care

Primary outcomes:
measure: The ability of Clotild® Smart Guidewire System to acquire electrophysiological measurements in the lesion and/or subintimal.
timeFrame: During the procedure
Secondary outcomes:
measure: The ability of Clotild® Smart Guidewire System to differentiate various tissues involved in Peripheral Artery Disease
timeFrame: During the procedure
Other outcomes:
Locations:
city: Dendermonde
country: Belgium
facility: AZ Sint Blasius
Study officials:
References:
Clinical trial NCT05706233: Erector Spinae Plane Block as a Rescue Pain Therapy in Patients Undergoing Laparoscopic Cholecystectomy
Official title: Effect of Postoperative Erector Spinae Plane Block as a Rescue Pain Therapy in Patients Undergoing Laparoscopic Cholecystectomy: A Historical Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Regional Anesthesia Morbidity
Cholecystitis, Chronic
Lead sponsor: Istanbul Saglik Bilimleri University
Sponsor class: OTHER
First posted: 2023-01-31
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing laparoscopic cholecystectomy

Brief summary: Laparoscopic cholecystectomy, one of the most commonly performed abdominal surgeries, is a gold standard therapy for surgical treatment of benign biliary diseases.

Erector spinae plane block (ESPB) was first presented in 2016 as the treatment of neuropathic pain in a case series, and gained popularity very quickly due to its safety applicability, and effect on both the visceral and parietal component of pain by providing paravertebral, transforaminal and epidural spread. Preoperative application of ESPB has taken its place as a part of multimodal analgesia in laparoscopic cholecystectomy cases over time and has been shown to reduce postoperative pain scores and opioid consumption and to improve quality of recovery scores. However, there is no data regarding the use of ESPB in the postoperative period as a rescue therapy.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing laparoscopic cholecystectomy
* Patients with NRS\>3 scores in the PACU

Exclusion Criteria:

* ASA \> 2
* Violation of standart protocol (anesthesia and analgesia)
* application of ESPB preoperatively
* age \> 65
* Surgery duration \>90min or \<45min

Primary outcomes:
measure: effect of ESPB applied postoperatively on the meperidine consumption in PACU
timeFrame: 1 HOUR
Secondary outcomes:
measure: effect of ESPB applied postoperatively on numeric rating scores in PACU
timeFrame: 1 HOUR
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Basaksehir Cam and Sakura City Hospital
Study officials:
References:
Clinical trial NCT04989933: Erector Spinae Plane Block With Two Different Volume for Open Heart Surgery
Official title: Ultrasound Guided Erector Spinae Plane Block With Two Different Volume for Open Heart Surgery: Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sternotomy Pain
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2021-08-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The erector spine plane block is currently used in many surgeries to provide postoperative analgesia. It has also been used successfully in open-heart surgery for postoperative sternotomy pain. However, an ideal volume that will provide optimum analgesia has not yet been determined.

This study aims to compare the effects of ESP block administered in two different volumes on poststernotomy pain.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologist's physiologic state I-III patients Undergoing Open Heart Surgery

Exclusion Criteria:

* chronic pain bleeding disorders renal or hepatic insufficiency patients on chronic non-steroidal anti-inflammatory medications emergency cases

Primary outcomes:
measure: Rescue analgesia
timeFrame: Post-extubation 24 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04785833: CD7 CAR-T in the Treatment of CD7 Positive Refractory Relapsed Acute Leukemia
Official title: A Prospective, Open, Single-arm Clinical Study on the Efficacy and Safety of CD7 CAR-T in the Treatment of CD7-positive Refractory Relapsed Acute Leukemia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: T-ALL
Lead sponsor: PersonGen BioTherapeutics (Suzhou) Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: The First Affiliated Hospital of Soochow University
First posted: 2021-03-08
Enrollment: 20
Sex: ALL
Minimum age (years): 12
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Patients with acute leukemia derived from T lymphocytes have the characteristics of high expression of CD7 antigen, such as acute T lymphocyte leukemia (T-ALL).CAR-T therapy is to genetically modify the patient's T lymphocytes to target and eliminate tumor cells in a major histocompatibility complex-independent manner. CAR-T cells are costimulatory molecules that include single-chain antibodies (scFv) that recognize tumor-specific antigens, hinge regions, transmembrane regions, intracellular signaling regions (immunoreceptor tyrosine activation motif ITAM), and intracellular signaling regions. The chimeric antigen receptor of CD28 or CD137(4-1BB) conduction domain is expressed in a lentiviral vector, and the vector is transfected into autologous T cells, so that the modified CAR-T cells have targeting and specificity Recognizes and kills cancer cells expressing tumor antigens, and can proliferate and activate in vivo, but has no effect on cells that do not express the antigen


Eligibility criteria: Inclusion Criteria:

* Age 12-65
* Sign informed consent
* Expected survival time ≥ 3 months
* CD7 positive refractory and relapsed acute leukemia
* Karnofsky score≥60
* ECOG score ≤ 2
* Have not received other immunotherapy within 3 months
* The CD7 expression rate on the surface of leukemia cells detected by flow cytometry is greater than 30%

Exclusion Criteria:

* Uncontrolled active infection
* Active viral hepatitis B or C
* HIV test positive
* Congenital immunodeficiency patients
* Pregnant and breastfeeding patients
* Patients with central nervous system tumors or central nervous system leukemia
* The patient and/or family members do not agree to the treatment plan

Primary outcomes:
measure: DLT
timeFrame: Up to 2 years
Secondary outcomes:
measure: Safety results
timeFrame: Up to 2 years
measure: PK
timeFrame: Up to 2 years
measure: PD
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Suzhou
country: China
facility: The First Affiliared Hospital Of SOOCHOW University
state: Jiangsu
Study officials:
References:
Clinical trial NCT03241654: Decreasing Trigger Sensitivity Could Assist PEEP to Further Improve Regional Ventilation Distribution
Official title: Decreasing Trigger Sensitivity Could Assist PEEP to Further Improve Regional Aeration and Homogeneity During Pressure Assist Ventilation: A Preliminarily Physiological Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mechanical Ventilation
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2017-08-07
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The postoperative patients receiving pressure support ventilation and existing heterogenous ventilation.

Brief summary: In mechanically ventilated patients during supine position, alveolar collapse usually distributes in dependent lung region.Decrease of flow trigger sensitivity might improve homogeneous of tidal volume distribution.

Detailed description: In mechanically ventilated patients during supine position, alveolar collapse usually distributes in dependent lung region. High positive end expiratory pressure (PEEP) has been applied to improve the homogeneous distribution of ventilation by increasing the end expiratory lung ventilation (EELV) and alveolar recruitment. However, for patients who increasing PEEP in some extent still existed poor aeration in the dependent region, further elevating PEEP seems to be unreasonable that perhaps lead to overdistension. Decreasing trigger sensitivity might further evoke inspiratory efforts to improve the ventilation for this type of patients.The Electrical impedance tomography (EIT) was applied in monitoring the regional ventilation distribution at the bedside.

Eligibility criteria: Inclusion Criteria:

1. The post operative patients who received pressure support ventilation;
2. After the clinical PEEP was evaluated 5cmH2O, the tidal volume distribution still existed heterogeneity.

Exclusion Criteria:

1. Under 18 years;
2. History of diaphragm dysfunction and surgery;
3. Central respiratory drive dysfunction;
4. history of esophageal, gastric or lung surgery;
5. The contraindication of using EIT (pacemaker, defibrillator, and implantable pumps).

Primary outcomes:
measure: The homogeneity of distribution of tidal volume
timeFrame: within 20 minutes after changing flow trigger
Secondary outcomes:
measure: Changes in global and regional EELV
timeFrame: within 20 minutes after changing flow trigger
Other outcomes:
Locations:
city: Beijing
country: China
facility: Jian-Xin Zhou
state: Beijing
Study officials:
affiliation: Beijing Tiantan Hospital
name: Jian-Xin Zhou, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00585533: A Phase 2 Study of Tarceva for Untreated, Good Prognosis Patients With Advanced Non-Small Cell Lung Cancer
Official title: A Phase 2 Study of Tarceva for Untreated, Good Prognosis Patients With Advanced Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lung Cancer
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2008-01-03
Enrollment: 40
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: This study will evaluate Tarceva in a selected population of patients with untreated advanced non-small cell lung cancer who are anticipated to have a relatively good (indolent) prognosis based on clinical criteria. It is anticipated that selection will enrich for tumor characteristic that are likely to be benefited by EGFR inhibitor treatment (survival greater than 90 days). The goal of this strategy is to provide a less toxic, oral treatment for patients with advanced NSCLC that will not interfere with patients receiving chemotherapy at some point in the future and may prolong the time to chemotherapy related progression.

Patients will remain on study until disease progresses, a decline in performance status, if patient cannot tolerate the side effects or develops symptoms requiring conventional chemotherapy.

Detailed description: Primary Objective To determine Time to Chemotherapy Progression (ie includes time on Tarceva monotherapy and chemotherapy) in advanced NSCLC

Secondary Objectives To evaluate survival and response rate associated with Tarceva treatment To study the frequency of symptom improvement (Lung Cancer Subscale)

Eligibility criteria: Inclusion Criteria:

* Performance status 0-1.
* Weight Loss \< 10% in preceding 3 months
* Age 18 years and older.
* Adjuvant chemotherapy allowed if \> 6 months from protocol entry
* Adequate Organ Function
* Liver enzymes \< 2X normal, bilirubin = normal
* Oxygen saturation\> 89% on room air unless chronically oxygen dependent (not cancer related)
* Creatinine \<2.0 mg

Exclusion Criteria:

* Not pregnant or lactating.
* No Clinical Brain Metastases
* No prior chemotherapy for systemic disease
* Imminent need for chemotherapy for impending organ dysfunction is not allowed

Primary outcomes:
measure: Survival Rate at 6-months Chemotherapy-progression-free (CP-free)
timeFrame: 6 months
Secondary outcomes:
measure: Overall Survival
timeFrame: 24 months
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: University of Utah
name: Wallace Akerley, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02258633: The Seatbelt Intervention Study
Official title: A Brief Tailored Family-centered Seatbelt Intervention for Hospitalized Trauma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: High Risk Population of Part-time Seatbelt Users
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2014-10-07
Enrollment: 200
Sex: ALL
Minimum age (years): 7
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study will use a randomized controlled design testing the effectiveness of the following intervention: (i) intervener brief intervention (IBI) vs. (ii) Enhanced usual care (EUC). The study will identify children ages 2-14 at a pediatric trauma center. Children and their parents who agree to participate in the study will then complete a screening survey to identify part time seatbelt use. Those who screen positive will complete a more detailed baseline survey and then be randomized to one of two study conditions. At one month, a follow up assessment by telephone will be completed.


Eligibility criteria: Inclusion Criteria:

* Children ages 7-14 and their parent or guardian, at a pediatric trauma center
* Child admitted to hospital with diagnosis of injury other than sexual assault and suicide
* Identify as part time seat belt users

Exclusion Criteria:

-

Primary outcomes:
measure: Seat belt use
timeFrame: 1 month
measure: Seat belt knowledge
timeFrame: 1 month
measure: Attitudes
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: