louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03024242: Tight Vaginoscopy: a Simplified Novel Technique for a Better Vaginal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Endosalpingiosis
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-01-18
Enrollment: 34
Sex: FEMALE
Minimum age (years): 10
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Bivalve vaginal speculum insertion is a basic final step of vaginal examination. Unfortunately, it can't be inserted in young girls, virgins, nulliparous women with narrow vagina, women with vaginismus or patients with a history of previous vaginal surgery. In such cases, the value of vaginoscopy (examination of the vagina without speculum) is evident. Indications of vaginoscopy are expanding. In addition to confirmation of suspected vaginal masses or polypi diagnosis, it can be used to diagnose laceration of the vaginal wall in girls due to foreign body , traumatic injuries or sexual abuse. In a systematic review, the effectiveness and feasibility of using hysteroscopy for exploration of the immature genital tract (vaginoscopy) were documented.It may help in the diagnosis and treatment of gynecologic disorders in adolescent patients with an intact hymen, limited vaginal access, or a narrow vagina. Another recent systematic review highlighted the importance of Vagino-hysteroscopy as an easy way to gain access to the cervical canal and an important tool with which to diagnose and treat vaginal lesions.

In practice, we notice leakage of excessive irrigating fluid per vagina with poor visualization during vaginoscopy. To the best of our knowledge, no study addressed a solution to improve visualization and success of vaginoscopic surgery. This study aims to test feasibility and doctor satisfaction of performing conventional diagnostic vaginoscopy if compared to tight diagnostic vaginoscopy and success on performing tight vaginoscopic surgery in patients with vaginal or cervical lesions.


Eligibility criteria: Inclusion Criteria:

* Symptomatizing women with suspected narrow vagina.
* Nulliparous women or virgin w
* Vaginal or cervical lesion or foreign body.

Exclusion Criteria:

* Multiparous women
* Nulliparous women with patulous or lax vaginae were excluded.

Primary outcomes:
measure: The success rate of the procedure
timeFrame: 20 minutes
Secondary outcomes:
measure: The satisfaction rate by satisfaction score
timeFrame: 20 minutes
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Women Health Hospital - Assiut university
Study officials:
References:
Clinical trial NCT05724342: Tenecteplase REperfusion in Acute Ischemic sTroke Registry（TREAT）
Official title: Tenecteplase REperfusion in Acute Ischemic sTroke Registry
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stroke, Ischemic
Keywords: thrombolysis
tenecteplase
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
Collaborators: name: National Natural Science Foundation of China
name: Beijing Municipal Science & Technology Commission
name: Beijing Municipal Administration of Hospitals
First posted: 2023-02-13
Enrollment: 1600
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: acute ischemic stroke patients treated with rhTNK-tPA and derivatives in China.

Brief summary: The aim of the study was to establish tenecteplase thrombolysis database and to investigate the effectiveness and safety of rhTNK-tPA in acute ischemic stroke patients.

Detailed description: Tenecteplase (TNK), as a newer fibrinolytic agent, has practical delivery advantages over alteplase that would make it a potential alternative. Several randomized controlled clinical trials demonstrated the noninferiority of TNK but the evidence on the effectiveness and safety of TNK in the real-world is insufficient.

This is a multi-center, prospective, registry cohort study that enrolled acute ischemic stroke patients treated with TNK thrombolysis in China.

Eligibility criteria: Inclusion Criteria:

* Older than 18 years;
* Diagnosed as acute ischemic stroke；
* Time intervals ≤ 4.5 hours from stroke onset to thrombolysis with TNK(Perfusion imaging completed including CTA+CTP or MRA+PWI+DWI before thrombolysis if the time intervals from stroke onset to thrombolysis was ≥4.5 hours)；
* Thrombolysis with rhTNK-tPA and derivatives.

Exclusion Criteria:

* Unlikely to adhere to the study protocol or follow-up ( life expectancy ≤ 3 months)；
* Already participated in other interventional trials.

Primary outcomes:
measure: Excellent functional outcome at 90 days
timeFrame: 3 months after thrombolysis
Secondary outcomes:
measure: Favorable functional outcome
timeFrame: 3 months after thrombolysis
measure: Walk independence
timeFrame: 3 months after thrombolysis
measure: Ordinal distribution of mRS at 90 days
timeFrame: 3 months after thrombolysis
measure: Neurological improvement at 24 hours
timeFrame: 24 hours after thrombolysis
measure: NIHSS score at discharge
timeFrame: 5-7days after thrombolysis or at discharge
measure: EQ-5D score at 90 days
timeFrame: 3 months after thrombolysis
measure: Barthel(BI) at 90 days
timeFrame: 3 months after thrombolysis
Other outcomes:
measure: Symptomatic intracerebral hemorrhage at 36 hours
timeFrame: 36 hours after thrombolysis
measure: Hemorrhage in other parts
timeFrame: 36 hours after thrombolysis
measure: Mortality at 90 days
timeFrame: 90 days after thrombolysis
Locations:
city: Beijing
country: China
facility: Yunyun Xiong
Study officials:
affiliation: Beijing Tiantan Hospital
name: Yunyun Xiong, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02478242: Trial to Assess the Efficacy and Safety of Nafamostat Mesilate During Continuous Renal Replacement Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Kidney Injury
Lead sponsor: Kyungpook National University Hospital
Sponsor class: OTHER
First posted: 2015-06-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Randomized study to evaluate the efficacy and safety of nafamostat mesilate use during continuous renal replacement therapy in acute kidney injury patients at a high risk of bleeding.

Detailed description: Patients were randomly assigned to the nafamostat mesilate (NM) group or the no anticoagulant (NA) group. In patients assigned to the NM group, NM (20mg/h) was used for maintenance anticoagulation. Whereas, in patients assigned to the NA group, normal saline (2mL/h) was infused for continuous renal replacement therapy.

Eligibility criteria: Inclusion Criteria:

* Patients who were admitted to the intensive care unit and required CRRT

  1. active bleeding such as gastrointestinal bleeding and intracranial hemorrhage,
  2. activated partial thromboplastin time \> 60 s,
  3. prothrombin time-international normalized ratio \> 2.0,
  4. thrombocytopenia (\<100,000/µL), and
  5. surgery within 48 h before CRRT.

Exclusion Criteria:

* Pregnant or possibly pregnant women
* Patients who were allergic to nafamostat mesilate
* Patients who were hypercoagulable

Primary outcomes:
measure: Number of filters used per hour
timeFrame: 24 months
Secondary outcomes:
measure: Urea reduction ratio
timeFrame: 24 months
measure: Survival rate
timeFrame: 24 months
Other outcomes:
Locations:
Study officials:
affiliation: Associate Professor
name: Chan-Duck Kim, M.D., PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tsujimoto H, Tsujimoto Y, Nakata Y, Fujii T, Takahashi S, Akazawa M, Kataoka Y. Pharmacological interventions for preventing clotting of extracorporeal circuits during continuous renal replacement therapy. Cochrane Database Syst Rev. 2020 Dec 14;12(12):CD012467. doi: 10.1002/14651858.CD012467.pub3.
Clinical trial NCT02567942: Assessment of the Anesthetic Effect on the Activity of Immune Cell in Patient With Colon Cancer
Official title: Assessment of the Anesthetic Effect on the Activity of Immune Cell in Patient With Colon Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colon Cancer
Lead sponsor: Konkuk University Medical Center
Sponsor class: OTHER
First posted: 2015-10-05
Enrollment: 153
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: BASIC_SCIENCE

Brief summary: Anesthetics agents has variety inflammation during the cancer surgery. This perioperative inflammation can influence to cancer metastasis or recurrence.

The purpose of this study is to prove the variation of immune cell activity between preoperative and postoperative period.

Detailed description: The patients were allocated randomly to receive propofol or sevoflurane. Also, a total of 18ml of blood sample was obtained for total 3 times in consecutive order.

1. immediate before anesthesia induction
2. postoperative 1 hours
3. postoperative 24 hours

Serum in blood will be obtained and activity of helper T cell, natural killer cell and level of serum cytokine will be evaluated by flow cytometry or enzyme-linked immunosorbent assay

Eligibility criteria: Inclusion Criteria:

* patient who was planned to undergo colon cancer surgery.

Exclusion Criteria:

* age \< 20 years old
* history of hypersensitivity reaction in propofol or sevoflurane
* history of previous cancer
* patient with ongoing inflammation

Primary outcomes:
measure: natural killer cell activity
timeFrame: preoperative time. postoperative 1 hours and 24 hours
Secondary outcomes:
measure: helper T cell activity
timeFrame: preoperative time. postoperative 1 hours and 24 hours
Other outcomes:
measure: change of percentage of CD39 and CD73
timeFrame: preoperative time. postoperative 1 hours and 24 hours
Locations:
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center
Study officials:
affiliation: Konkuk University Medical Center
name: Seong-Hyop Kim, M.D,Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01903642: Study of the Proteome and Cytokines During Inflammatory Syndromes of Different Etiologies.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Inflammatory Disease
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2013-07-19
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: The hypotheses of our research are based on the fact that various pathological states, infection, cancer, inflammatory disease, can induce an inflammatory syndrome, through different pathways, even though the clinical presentation can be identical. The identification of biological markers specific to an etiology would therefore allow a faster diagnosis and improve care for patients. We thus took an interest in the three groups of diseases most frequently responsible for an inflammatory syndrome, infections, cancers and auto-immune diseases. To achieve this, various methods will be used.


Eligibility criteria: Inclusion Criteria:

Patients presenting an inflammatory syndrome, defined by elevated C-reactive protein (CRP\>50mg/L), whose etiology is related to infection, cancer or an inflammatory disease.

* Patients not on treatment (corticoids, immunosuppressive drugs) during the 7 days preceding inclusion
* Age: 18-90 years
* Patients covered by the National Health Insurance Agency
* signed written informed consent form

Exclusion Criteria:

* - Any patient not meeting the inclusion criteria
* Pregnant patients

Primary outcomes:
measure: determination of usual parameters of inflammation
timeFrame: at baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU de Dijon
Study officials:
References:
Clinical trial NCT00002342: A Study of Tecogalan Sodium
Official title: A Phase I Trial of Tecogalan Sodium (DS-4152) Administered as an Infusion Twice Weekly for 21 Days
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Sarcoma, Kaposi
HIV Infections
Keywords: Neoplasms
Sarcoma, Kaposi
Acquired Immunodeficiency Syndrome
Antineoplastic Agents
tecogalan
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: To evaluate the safety of different doses and dosing regimens of tecogalan sodium (DS-4152) and to establish the MTD at each of the different dosing schedules.

Detailed description: Patients receive intravenous DS-4152 by infusion twice weekly for 21 days, followed by 2 weeks of rest; courses may repeat. Patients undergo weekly follow-up. A punch biopsy will be obtained from patients with Kaposi's sarcoma.

Eligibility criteria: Inclusion Criteria

Patients must have:

* Kaposi's sarcoma plus HIV infection OR metastatic solid tumor.
* Life expectancy of at least 12 weeks.
* NO symptomatic AIDS-defining opportunistic infection within the past 4 weeks.
* Recovered from toxicity of any prior anticancer therapy.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Leukemia or lymphoma.
* Current gastrointestinal bleeding by stool guaiac.
* Extensive bone metastases or significant radiographic osteoporosis in patients with solid tumors.
* Active heart disease such as uncontrolled angina, uncompensated congestive heart failure, or dysrhythmias requiring antiarrhythmics.
* Acute intercurrent infection other than genital herpes.
* Symptomatic or known central nervous system involvement (including brain metastases) unless stable and off therapy.

Concurrent Medication:

Excluded:

* Other anticancer therapy.
* Other investigational agents.

Patients with the following prior conditions are excluded:

* History of acute or chronic gastrointestinal bleeding or inflammatory bowel disease.
* History of myocardial infarction within past 6 months.

Prior Medication:

Excluded:

* Anticancer therapy within the past 3 weeks (6 weeks for nitrosourea or mitomycin C).
* Investigational agents within the past 4 weeks.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Mem Sloan - Kettering Cancer Ctr
state: New York
Study officials:
References:
Clinical trial NCT01184742: 6 Minute Push & 30 Second Sprint Tests Reliability & Relationship to Fitness, Participation, & Environmental Assessments
Official title: 6 Minute Push and 30 Second Sprint Tests Reliability and Relationship to Fitness, Participation, and Environmental Assessments
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Cord Injury
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: Paralyzed Veterans of America
First posted: 2010-08-19
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community sample of persons with spinal cord injury.

Brief summary: The purpose of this study is to assess the relationship between physical fitness and wheelchair mobility capacity and 1) participation; 2) self-reported environments barriers; and 3) self-reported avoidance of environmental features.


Eligibility criteria: Inclusion Criteria:

* at least 1 year post-injury
* able to self-propel a manual wheelchair
* spinal cord injury between C5 and T5

Exclusion Criteria:

* spinal cord injury above C5 or below T5
* spinal cord injury severity of AIS D
* unstable angina or myocardial infarction within the past month
* resting heart rate \>120
* systolic blood pressure \>180 mm Hg, or diastolic blood pressure \>100 mm HG

Primary outcomes:
measure: 6 Minute Push Test
timeFrame: Visit 3 and 4
measure: 30 Second Sprint Test
timeFrame: Visit 3 and 4
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: The Miami Project to Cure Paralysis
state: Florida
Study officials:
affiliation: University of Miami, The Miami Project to Cure Paralysis
name: Mark S Nash, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03085342: Evaluation of Hepatic Fibrosis on Multiparametric MRI
Official title: Evaluation of Hepatic Fibrosis on Multiparametric MRI Including Portal Flow Measurement Using Dual-input Software: Preliminary Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cirrhosis
Hepatitis
Keywords: liver
fibrosis
MRI
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: GE Healthcare
First posted: 2017-03-21
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: As cirrhosis progresses, alteration of hemodynamics develops and decreased portal flow is often observed. Since direct measurement of portal pressure (HVPG) is invasive, non-invasive methods have drawn a lot of attention. MRI is one of the non-invasive methods and it is able to provide multiparametric data in one examination. Herein, we evaluate hepatic fibrosis with different stage using multiparametric MRI with emphasis on portal flow measurement.


Eligibility criteria: Inclusion Criteria:

* chronic liver disease (viral hepatitis, alcoholic hepatitis, or other...)
* Or transplant recipient for viral hepatitis and on anti-viral agent medication
* AND scheduled for liver resection, biopsy or transient elastography
* AND signed informed consent

Exclusion Criteria:

* younger than 18 years
* any contra-indication for contrast-enhanced MRI
* pregnant or nursing women
* biliary obstruction
* unable or unwilling to give informed consent

Primary outcomes:
measure: hepatic fibrosis stage
timeFrame: 1 month after MRI
Secondary outcomes:
measure: presence of varix
timeFrame: 1 month after MRI
measure: comparison of portal flow measurement
timeFrame: 1 month after MRI
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jeong Min Lee, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01933542: The Effect of Chlorzoxazone on Moderate to Severe Postoperative Pain After Spine Surgery
Official title: The Effect of Chlorzoxazone on Moderate to Severe Postoperative Pain After Spine Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chlorzoxazone
Postoperative Pain
Keywords: Chlorzoxazone
Postoperative pain
Spine surgery
Opioid consumption
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Glostrup University Hospital, Copenhagen
First posted: 2013-09-02
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Chlorzoxazone is a centrally acting muscle relaxant used to treat muscle spasm and the resulting pain or discomfort. It acts on the spinal cord by depressing reflexes. Our purpose is to investigate the effect of chlorzoxazone on moderate to severe postoperative pain after spine surgery. Our hypothesis is that chlorzoxazone can reduce postoperative pain and reduce opioidconsumption and side effects compared to placebo.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing spine surgery in general anaesthesia.
* Postoperative pain \> 50 mm on the VAS scale during mobilization.
* Patients who have not received analgesia 1 hour prior to inclusion.
* ASA 1-3.
* BMI \> 18 og \< 40.
* Fertile women need a negative HCG urine test.
* Patients who have given their written consent to participate and understand the contents of the protocol.

Exclusion Criteria:

* Participation in another clinical trial.
* Patients who do not speak and/or understand Danish.
* Fertile women with a positive HCG urine test.
* Allergy to the drugs used in the trial.
* Alcohol or medicine abuse, assessed by investigator.
* Daily use of strong opioids (morphine, ketobemidone, oxynorm, methadone, fentanyl)
* Daily chlorzoxazone treatment.
* Known or suspected porphyria.

Primary outcomes:
measure: Painscore during mobilization
timeFrame: 2 hours after taking the trial medication
Secondary outcomes:
measure: Morphine consumption
timeFrame: 0-4 hours after taking the trial medication
measure: Painscore during rest
timeFrame: 1, 2, 3 and 4 hours after taking the trial medication
measure: Painscore during mobilization
timeFrame: 1, 2, 3 and 4 hours after taking the trial medication
measure: Degree of nausea
timeFrame: 1, 2, 3 and 4 hours after taking the trial medication
measure: Zofran consumption
timeFrame: 4 hours after taking the trial medication
measure: Degree of dizziness
timeFrame: 1, 2, 3 and 4 hours after taking the trial medication
measure: Incidence of vomiting
timeFrame: 0-4 hours after taking the trial medication
measure: Degree of sedation
timeFrame: 1, 2, 3 and 4 hours after taking the trial medication
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Glostrup University Hospital
Study officials:
affiliation: Glostrup University Hospital
name: Rikke Soennichsen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05990842: "Enhancing Surgical Safety in Developing Nations: Investigating Antibiotics' Role in Hand Surgeries."
Official title: "Antibiotic Prophylaxis in Clean Soft Tissue Hand Surgery Among a Population in a Developing Country: A Randomized, Parallel, Triple-Blind, Placebo-Controlled Clinical Trial"
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Soft Tissue Injuries
Keywords: antibiotic prophylaxis
hand surgery
orthopedic surgery
postoperative care
surgical wound infection
developing country
Lead sponsor: University of Campinas, Brazil
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this clinical trial is to compare the use of antibiotics with no use in people undergoing soft tissue hand surgery in developing countries.

The main question it aims to answer is:

• Is an antibiotic necessary for this type of surgery in this population? Researchers will compare a group of patients who receives antibiotics during the surgical procedure with a group who receives no antibiotics to see if infection rates are the same.


Eligibility criteria: Inclusion Criteria:

* individuals with clean soft tissue conditions of the upper limb requiring surgery

Exclusion Criteria:

* abandonment of treatment
* ASA \> 3

Primary outcomes:
measure: Surgical wound infection
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Campinas, Brazil
name: Marcos M de Abreu, MD
role: PRINCIPAL_INVESTIGATOR
References: