louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03001531: Safety and Tolerance of Local Heat Application in the Paralyzed Area of Patients With Complete Paraplegia
Official title: Safety and Tolerance of Local Heat Application in the Paralyzed Area of Patients With Complete Paraplegia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Perfusion; Complications
Keywords: Complete paraplegia
Lead sponsor: Swiss Paraplegic Research, Nottwil
Sponsor class: NETWORK
Collaborators: name: University Hospital, Basel, Switzerland
First posted: 2016-12-23
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Preconditioning of regional skin is known to reduce post surgery complications due to increased perfusion and better skin condition. The aim of this study is to prove that local heating through a standardized device in patients with spinal cord injury induces no burnings or other relevant side effects. The investigators expect an increased regional perfusion, temperature and redness.


Eligibility criteria: Inclusion Criteria:

* men and women
* aged from 18 to 65 years
* paraplegia Th2-Th12
* spinal cord injury had occurred \>12 weeks ago

Exclusion Criteria:

* infections
* fever
* diabetes
* heart failure stadium III
* renal insufficiency stadium III.
* scars, wounds or other injuries in the area of treatment
* skin type V and VI on Fitzpatrick scale

Primary outcomes:
measure: presence of burn injury
timeFrame: up to 24 hours
Secondary outcomes:
measure: blood perfusion
timeFrame: before and 1min after the application of light or heat
measure: skin surface temperature
timeFrame: before and 1min after the application of light or heat
measure: skin redness
timeFrame: before and 1min after the application of light or heat
Other outcomes:
Locations:
city: Nottwil
country: Switzerland
facility: Swiss Paraplegic Centre
Study officials:
References:
Clinical trial NCT01897831: Piperacillin Sodium and Sulbactam Sodium for Injection (2:1) for Treatment of Respiratory and Urinary Tract Infection
Official title: A Open Multi-center Clinical Study on Piperacillin Sodium and Sulbactam Sodium for Injection (2:1) for Treatment of Respiratory and Urinary Tract Infection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Respiratory Tract Infections
Urinary Tract Infections
Keywords: Piperacillin Sodium and sulbactam sodium
Phase IV clinical studies
Respiratory and urinary tract infections
Lead sponsor: Xiangbei Welman Pharmaceutical Co., Ltd
Sponsor class: INDUSTRY
First posted: 2013-07-12
Enrollment: 2000
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: In the proposed study, the investigators plan to evaluate the efficacy and safety of Piperacillin sodium and sulbactam sodium for injection (2:1) for the treatment of respiratory and urinary tract acute bacterial infection under the widely used in clinical conditions.

Detailed description: Piperacillin sodium and sulbactam sodium for injection (2:1) plays a therapeutic role by the former inhibiting bacterial cell wall synthesis by irreversible competitive inhibition of β-lactamase. The antimicrobial effect of cefotaxime can be enhanced by the two combined. The compound specifically aims to the mechanism of bacterial resistance, extending the life of Piperacillin in the treatment-resistant pathogen infections.

Eligibility criteria: Inclusion Criteria:

1. patients who qualify for moderate and severe acute respiratory or urinary tract bacterial infection of acute bacterial infections need for systemic antibiotic therapy.
2. Age\>18 years old, Gender: both
3. Women of childbearing age were to be negative pregnancy test and agree to take contraceptive measures during the trial;
4. patients were volunteers and signed informed consent form;
5. patients did not participate in other clinical trials.

Exclusion Criteria:

1. Patients were hypersusceptibility to the test drug or other penicillins ,β-lactamase inhibitor
2. Pregnant and Lactating women
3. Patients have severe liver,kidney,cardiovascular,cerebrovascular,endocrine and hematopoietic system of primary diseases and that of immunodeficiency,advanced cancer or mental illness.
4. Patients who were complicated by other diseases and thought to affect efficacy evaluations or poor compliance.

Primary outcomes:
measure: overall effect
timeFrame: two year
Secondary outcomes:
measure: Number of participants with Adverse Events
timeFrame: two year
Other outcomes:
Locations:
Study officials:
affiliation: Chongqing Red Cross Hospital
name: changqing cq li, doctor
role: STUDY_DIRECTOR
References:
Clinical trial NCT03053531: Hearing Resources and Outcomes in the Emergency Department (HERO-ED)
Official title: Hearing Resources and Outcomes in the Emergency Department (HERO-ED)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Hearing Loss
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2017-02-15
Enrollment: 0
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single-group study, with no control or comparison group.
Primary purpose: TREATMENT

Brief summary: The Hearing Resources and Outcomes in the Emergency Department Pilot (HERO-ED Pilot), gathers preliminary data and hones procedures and measures, prior to undertaking HERO-ED. Since the HERO-ED Pilot does not involve random assignment (no control group), it will not test device effectiveness. However, the HERO-ED Pilot will test device acceptability and use. It will also provide preliminary data on, and allow us to fine-tune, the measures of effectiveness that we plan to use in HERO-ED

Detailed description: The objectives are:

1. Measure the feasibility of in-ED hearing screening using HHIE-S and a handheld audiometer, among low-acuity11 ED patients age ≥75 years, by quantifying the proportion of eligible patients who complete hearing screening.
2. Test whether low-acuity older ED patients who screen positive for significant hearing loss (\> 40 dB HL bilaterally and HHIE-S \> 24) and are provided a hearing assistance device (HAD) use that device during the ED visit.
3. Test whether patients who are given a hearing assistance device will report ability as opposed to disability in hearing and understanding, using a six-item questionnaire adapted from a study by Cox et al.
4. Test whether those who are given a hearing assistance device will report being prepared for post-discharge care, using an adapted subset of the Care Transitions Measures (CTM).
5. Assess patient understanding of the HAD survey items within the post-use survey.

Eligibility criteria: Inclusion Criteria:

* low acuity clinical presentation (Emergency Severity Index11 triage criteria of 4 or 5, which indicates a high likelihood of being discharged home from the Emergency Department).
* Patients using hearing aids will not be excluded.

Exclusion Criteria:

* Lack of capacity to consent, as defined by the patient's ability to satisfactorily answer the questions outlined in the Evaluation to Sign Consent form (ESC) mentioned in the protocol. A legal representative/family member will not be able to consent for the patient in this study.

Primary outcomes:
measure: Measure the feasibility of in-ED hearing screening using HHIE-S
timeFrame: 5 Minutes
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University Medical Center
state: New York
Study officials:
affiliation: NYU Langone Health
name: Joshua Chodosh
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00805831: Safety and Efficacy of Using HDH Device and Method - a Novel Sutureless Vascular Anastomosis
Official title: Safety and Efficacy of Using HDH Device and Method - a Novel Sutureless Vascular Anastomosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vascular Disease
Atherosclerosis
Keywords: sutureless vascular bypass
Lead sponsor: HDH Medical Ltd
Sponsor class: INDUSTRY
First posted: 2008-12-10
Enrollment: 10
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 HDH device is intended for creating sutureless vascular anastomosis in various blood vessels. The HDH device consists of four parts: an elastic tube (graft), docking head (anastomotic device), inversion device (connects the vascular graft to HDH) and measuring device. This study was design in order to evaluate the safety and efficacy of using HDH device and method an innovative anastomotic device for sutureless aortic anastomosis in patient diagnosed with abdominal aneurysm or Aorto-iliac aneurysm.


Eligibility criteria: Inclusion Criteria:

* Patient age above 18 (men and woman)
* Patient suffers from infrarenal abdominal aortic or Aorto-iliac aneurysm
* Aneurysm diameter is larger than 5cm/ its annual growth is more than 0.5cm/or iliac aneurysm size is larger than 2.5cm
* The abdominal aneurysm neck is longer than 1.5 cm
* Patient's physical condition allows performing general anesthesia
* Patient is willing to sign the informed consent and follow the study protocol.

Exclusion Criteria:

* Patient Age under 18 years
* Patient's physical condition dose not allows to perform general anesthesia
* Patient's with terminal disease and life expectancy of less than 3 months
* Patient objects to the treatment or study protocol
* Anesthesiologist or personal care physician object
* Patient suffer from Supra/infrarenal AAA
* The abdominal aneurysm neck is smaller than 1.5 cm
* Aneurysm diameter is smaller than 5cm/ its annual growth is less than 0.5cm/

Primary outcomes:
measure: To establish safety of using the HDH device for creating sutureless aortic anastomosis. Safety will be established by lack of serious adverse events.
timeFrame: within 1 month
Secondary outcomes:
measure: Time to complete the anastomosis
timeFrame: during the surgery
Other outcomes:
Locations:
city: Ashkelon
country: Israel
facility: Barzilai Medical center
Study officials:
affiliation: Barzilai Medical Center, Ashkelon, Israel
name: Boris Yofee, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06241131: The Quality of Recovery From General Anesthesia With Desflurane for Fundus Surgery
Official title: Study on the Quality of Recovery From General Anesthesia With Desflurane for Fundus Surgery-A Single Center, Prospective, Randomized, Double-blind, Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Desflurane Anesthesia
Postoperative Recovery
Lead sponsor: Sichuan Provincial People's Hospital
Sponsor class: OTHER
First posted: 2024-02-05
Enrollment: 220
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: SCREENING

Brief summary: The goal of this clinical trials to study and compare the effects of "desflurane with remifentanil anesthesia (study group)" and "sevoflurane with remifentanil anesthesia (control group)" for elective fundus surgery anesthesia. The main question it aims to answer are the characteristics of desflurane anesthesia in patients undergoing fundus surgery and to provide universal guidance for clinical application.


Eligibility criteria: Inclusion Criteria:

1. ASA I-II, patients aged 18-65 years old;
2. Fundus surgery to be performed under general anesthesia ;
3. The expected duration of surgery is about 30-120 min ;
4. BMI: 18-30 kg/m2 ;
5. Those who signed the informed consent form and volunteered to participate in this trial

Exclusion Criteria:

1. Patients with known or suspected genetic susceptibility to malignant hyperthermia;
2. Patients with history of asthma;
3. Patients with severe heart diseases (NYHA ≥ III, severe arrhythmia, etc.) and cerebral or pulmonary diseases, liver or kidney dysfunction; or with unstable vital signs;
4. Patients with history of long-term narcotic analgesics application, including sedative and antidepressant drugs;
5. Patients with history of psychotropic drug abuse within 3 months;
6. Patients with long-term alcohol abuse;
7. People with mental disorder and unable to communicate normally;

Primary outcomes:
measure: Recovery time
timeFrame: up to 1 hour
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Sichuan Provincial People's Hospital
name: Ting Xu, MD
role: STUDY_CHAIR
References:
Clinical trial NCT05041231: Effects of Using Custom Photobiomodulation Therapy for the Treatment of Osteoarthritis of the Fingers and Rhizarthrosis
Official title: Effects of Using Custom Photobiomodulation Therapy for the Treatment of Osteoarthritis of the Fingers and Rhizarthrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Osteoarthritis Finger
Osteoarthritis Hand
Osteoarthritis Both Hands
Lead sponsor: Vita Care
Sponsor class: OTHER
Collaborators: name: Tegos S.A.
First posted: 2021-09-10
Enrollment: 46
Sex: ALL
Minimum age (years): 40
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Osteoarthrosis (OA), a multifactorial degenerative process, is responsible for joint pain and functional limitation. In the hand, more specifically in the proximal and distal interphalangeal joints of the fingers, it is one of the sites of greatest manifestation of the disease. Numerous treatments, whether drug, rehabilitation or surgery, have been proposed with the aim of both interrupting the natural evolution of the disease and alleviating or stopping the symptoms. This study aims to evaluate the effectiveness of personalized Photobiomodulation Therapy (PBT) with regard to alleviating symptoms and improving the quality of life of these patients with the disease.


Eligibility criteria: Inclusion Criteria:

* Clinical and radiological diagnosis of OA of the fingers of the hand and Rizarthrosis
* Patients with pain for at least 3 months
* Patients undergoing treatment and rehabilitation for finger OA and rhizarthrosis
* Patient with good understanding of the Portuguese language who agrees to participate and sign the ICF

Exclusion Criteria:

* Posttraumatic arthritic changes
* Systemic inflammatory arthritis (Rheumatoid Arthritis, Lupus Erythematosus, Psoriasis...)
* Patients with local or systemic, acute or chronic infections

Primary outcomes:
measure: Change from Baseline Pain at
timeFrame: 4 weeks and 2 months
measure: Change from Baseline Arm, Shoulder and Hand Disability
timeFrame: 4 weeks and 2 months
Secondary outcomes:
measure: Change from Baseline Hand grip
timeFrame: 4 weeks and 2 months
measure: Change from Baseline Pinch force
timeFrame: 4 weeks and 2 months
measure: Willingness to recommend the treatment
timeFrame: 4 weeks and 2 months
measure: Change from Baseline Hand Disability
timeFrame: 4 weeks and 2 months
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Instituto Vita
state: SP
Study officials:
affiliation: Medical Director Instituto Vita
name: Mateus Saito, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06551831: End-of-life Decision-making Among Young Patients With Advanced Cancer: a Grounded Theory Approach
Official title: End-of-life Decision-making Among Young Patients With Advanced Cancer: a Grounded Theory Approach
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: End-of-life Decision-making
Keywords: Young Patients
Advanced Cancer
Grounded Theory
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2024-08-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * The patient has a solid tumor.
* The age at initial cancer diagnosis is between 15 and 39 years.
* The patient is at least 18 years old at the time of enrollment.
* The patient has cancer with metastasis, either present at initial diagnosis or occurring after treatment or follow-up.
* After metastasis, the first-line curative treatment is ineffective.

Brief summary: The purpose of this qualitative research is to use grounded theory to explore and describe the thoughts of young advanced cancer patients regarding end-of-life care and how these thoughts influence the related decision-making process.


Eligibility criteria: Inclusion Criteria:

* The patient has a solid tumor.
* The age at initial cancer diagnosis is between 15 and 39 years.
* The patient is at least 18 years old at the time of enrollment.
* The patient has cancer with metastasis, either present at initial diagnosis or occurring after treatment or follow-up.
* After metastasis, the first-line curative treatment is ineffective.

Exclusion Criteria:

- Patients who, for any reason, including severe psychological distress (as determined by the attending physician, psychiatrist, or specialist nurse based on assessments and impressions during routine patient care), cognitive impairment, or physical limitations (such as frailty), are unable to communicate or participate in an interview lasting more than 30 minutes.

Primary outcomes:
measure: Interview Guide
timeFrame: 2024/7~2025/7
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References:
Clinical trial NCT04729231: Reconstruction Flaps for Nasal Surgical Wounds RCT
Official title: A Randomized Controlled Trial Comparing the Functional and Aesthetic Outcomes of Lobed Transposition Flaps vs. Nasalis Sling Flaps in Nasal Tip Reconstruction
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Surgical Wound
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2021-01-28
Enrollment: 0
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to determine whether there is a significant difference in aesthetic and functional outcomes between nasalis sling flaps and lobed flaps of nasal tip wounds requiring reconstruction.

This is a randomized clinical trial. Approximately 32 participants who are undergoing nasal tip wound reconstruction surgery will be invited to participate and randomized to receive either the nasalis sling repair or the lobed flap repair. Patients will be asked to complete a few questionnaires including a VAS scale, the Surgical Outcomes scale, the NOSE instrument, and the Nasal Appearance and Function Evaluation Questionnaire (NAFEQ).

This study was a pilot study designed to determine the feasibility of these procedures.


Eligibility criteria: Inclusion Criteria:

* All patients \>18 years
* Defect located on the nasal tip, infratip, or supratip of the nose
* Longest length of the wound should be no greater than 15mm
* Participants must have the ability to understand and the willingness to sign a written informed consent prior to registration on study

Exclusion Criteria:

* Active infection
* Age \<18
* Investigator judgement that patient is not suitable for randomization (preexisting scars or architecture that would make one repair option less likely to be successful)
* Current cigarette smoking
* Patients that have a disease or are taking medication that would severely impair wound healing in the opinion of the investigator

Primary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: 6-16 weeks after the procedure
measure: Surgical Outcome Scale
timeFrame: 6-16 weeks after the procedure
measure: Nasal Obstruction Symptom Evaluation (NOSE) Instrument
timeFrame: Baseline to 6-16 weeks
measure: Nasal Appearance and Function Evaluation Questionnaire (NAFEQ) Scale
timeFrame: Baseline to 6-16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Northwestern University
name: Murad Alam, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05410431: Intraorbital Dermoid/Epidermoid Cyst
Official title: Atypical Intraorbital Dermoid and Epidermoid Cyst: A Single Institution Cross-sectional Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dermoid Cyst of Orbit
Lead sponsor: Isfahan University of Medical Sciences
Sponsor class: OTHER
First posted: 2022-06-08
Enrollment: 9
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with Intraorbital Dermoid and Epidermoid Cyst

Brief summary: Intraorbital epidermoid and dermoid cyst (DC) has been reported in the literature rarely. The current study evaluates clinicopathologic, radiologic, and management of intraorbital DC cases over ten years.


Eligibility criteria: Inclusion Criteria:

* Those who had an excision biopsy with histology indicative of dermoid/epidermoid cyst

Exclusion Criteria:

* Other cystic lesions

Primary outcomes:
measure: Histopathology report
timeFrame: Ten years
measure: Magnetic Resonance Imaging report
timeFrame: Ten years
measure: Surgery technique
timeFrame: Ten years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: