louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01972243: Risk of Recurrent Venous Thrombosis: A Validation Study of the Vienna Prediction Model
Official title: Identification of Patients at Low Risk of Recurrent Venous Thromboembolism After Stopping Anticoagulant Treatment: A Prospective Multicenter Cohort Study (Validation of the Vienna Prediction Model)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Venous Thromboembolism
Keywords: risk of recurrent
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2013-10-30
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: first unprovoked deep vein thrombosis or pulmonary embolism

Brief summary: Because of a high recurrence risk after unprovoked venous thromboembolism (VTE) indefinite anticoagulation is recommended, but confers a considerable bleeding risk. It is important to identify patients, in whom the recurrence risk is lower than the expected bleeding risk, and who will not benefit from long term anticoagulation. By use of a scoring model (Vienna Prediction Model), patients can be stratified according to their recurrence risk based on their sex, location of VTE and D-Dimer. Before implementation in routine care, an independent validation is required. Patients with unprovoked VTE will stop anticoagulation after 3-7 months and the recurrence risk will be estimated by use of the Vienna Prediction Model. Low risk patients with a score of \<180 will be included and will be left untreated. Patients with a high score will not be included and their management will follow current guidelines. Follow-up will be two years and the endpoint will be recurrent symptomatic VTE.


Eligibility criteria: Inclusion Criteria:

Age \> 18 years symptomatic uni- or bilateral proximal (including the trifurcation area, popliteal, superficial femoral, deep femoral, common femoral and iliac vein) or distal DVT of the leg and/or symptomatic PE.

VTE not provoked by one of the following temporary risk factors: surgery, trauma,pregnancy, cancer, immobilisation.

Exclusion Criteria:

History of previous VTE; anticoagulation for longer than 6 months; reasons for long-term anticoagulation other than VTE; poor patient compliance; no consent to participate

Primary outcomes:
measure: recurrent venous thromboembolism
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
References:
Clinical trial NCT06251843: Support Strategies for Parents During the First Year Following Their Child's Diagnosis of Sickle Cell Disorder
Official title: Co-designing Support Strategies for Parents to Encourage Early Engagement With Health Services During the First Year Following Their Child's Diagnosis of Sickle Cell Disorder
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Sickle Cell Disease
Keywords: sickle cell disease, SCD, sickle cell anaemia
Lead sponsor: King's College London
Sponsor class: OTHER
Collaborators: name: British Academy
name: Sickle Cell Society
name: King's College Hospital NHS Trust
name: Guy's and St Thomas' NHS Foundation Trust
First posted: 2024-02-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Parents whose children have been diagnosed with SCD via screening in the last 36 months Health professionals involved in the care of children with sickle cell disorder

Brief summary: Background: Sickle cell disorder (SCD), the commonest genetic (faulty gene inherited from both parents) condition in the UK, affects mainly underserved groups. Babies with SCD must start treatments soon after birth to prevent them becoming unwell. Stigma, fear and inequalities can make it difficult for parents to accept their child's diagnosis and access appropriate treatment and support.

Aim: Develop strategies to improve support for parents during their child's first year of life following a SCD diagnosis to encourage early engagement with health services.

Method: Comprises two stages: (i) Determine why parents choose to engage with support or not (ii) Use this information to co-design strategies to ensure greater accessibility of support for parents during their child's first year of life.

Patient and Public Involvement: We are working with Sickle Cell Society and parents of children with SCD. Dissemination: Findings will be shared with support groups, charities, health professionals and academics.


Eligibility criteria: Inclusion Criteria:

* Parents whose children have been diagnosed with SCD via screening in the last 36 months
* Health professionals involved in the care of children with sickle cell disorder

Exclusion Criteria:

* Parents whose inclusion may be contradicted on psychosocial grounds or who are unable to give informed consent.
* Health professionals who do not have experience of caring for children with sickle cell disorder.

Primary outcomes:
measure: Support strategies for families with a child with SCD
timeFrame: June 2025
Secondary outcomes:
measure: Existing support
timeFrame: July 2024
measure: Parental reasons for accessing support
timeFrame: July 2024
measure: Support priorities
timeFrame: Sept 2025
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02974543: Auditory-somatosensory Stimulation to Alleviate Tinnitus
Official title: Combined Auditory-Somatosensory Stimulation to Alleviate Tinnitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tinnitus
Keywords: tinnitus
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Wallace H Coulter Center for Translational Research
First posted: 2016-11-28
Enrollment: 35
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 study is to develop and test a subject operated device to lessen tinnitus (ringing in the ear), based on subject-feedback for stimulus presentation.

Detailed description: This study consented 35 adult subjects. 21 subjects qualified and were randomized into the study. This project will develop and test a device with the ultimate goal of providing a patient operated device to alleviate phantom sound perception, or tinnitus, based on patient-feedback for stimulus presentation.

The device, an electrical-acoustical stimulus timing, is based on physiological findings of stimulus-timing-dependent plasticity in somatosensory and auditory nuclei,that when aberrant, contribute to tinnitus.

Eligibility criteria: Inclusion Criteria:

1. Constant, subjective, preferably unilateral tinnitus without any active external or middle ear pathology.
2. Hearing thresholds better than 50dB HL at peak tinnitus frequencies.
3. Able to modulate their tinnitus with a somatic maneuver
4. BothersomeTinnitus.

Exclusion Criteria:

* No participation in a tinnitus treatment regimen within the past four weeks
* Retrocochlear pathology/ VIIIth nerve lesion

Primary outcomes:
measure: Change in TFI (Tinnitus Functional Index) After Treatment or Sham Compared to Baseline
timeFrame: Four weeks on treatment (or sham)
measure: Change in Tinnitus Loudness as Assessed by TinnTester
timeFrame: 4 weeks on treatment (or sham)
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Kresge Hearing Research Institute
state: Michigan
Study officials:
affiliation: University of Michigan
name: Susan Shore, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02229643: Serum Neuroglobin and Nogo-A Concentrations in Acute Traumatic Brain Injury
Official title: Neuroglobin and Nogo-A as Biomarkers for the Prognosis of Closed Traumatic Brain Injury
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Traumatic Brain Injury
Keywords: Traumatic brain injury
Neuroglobin
Nogo-A
Prognosis
Lead sponsor: Shanghai 6th People's Hospital
Sponsor class: OTHER
First posted: 2014-09-01
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patient group comprised 21 male and 13 female. Their age ranged from 19 to 68 years, with mean age of 45.1 years. The mechanisms of trauma included motor vehicle collisions, falls, heavy strikes (patients who were hit by heavy objects such as bricks, sticks, or falling objects) and assaults. Types of lesions, as evidenced by radiologic and neurologic symptoms or signs, included cerebral contusions/lacerations, intracranial hematomas, brain stem injury and diffuse axonal injury.

Brief summary: Neuroglobin has been described as a marker of traumatic brain injury. Nogo-A plays an important role in mediating neuroanatomical plasticity and functional recovery following traumatic brain injury. The investigators sought to examine the changes in serum neuroglobin and Nogo-A concentrations in patients with traumatic brain injury during the initial 96-h posttraumatic period and assessed the relation of neuroglobin and Nogo-A to Glasgow Coma Score and prognosis of such patients with traumatic brain injury.


Eligibility criteria: Inclusion Criteria:

* Patients who suffered head trauma and whose highest abbreviated injury score (AIS) was 3 or less (other than head injury)
* Patients who delivered to hospital within 4 h

Exclusion Criteria:

* Patients who suffered open injuries
* Patients who had existing prior neurological disease
* Patients whose serial serum samples could not be obtained
* Patients less than 18 years of age
* Patients who suffered severe life-threatening injury to organs other than the brain

Primary outcomes:
measure: Glasgow Outcome Scale scores
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Sixth People's Hospital
Study officials:
affiliation: Shanghai 6th People's Hospital
name: Lixia Xue, M.D., Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT02190643: Improving Nicotine Patch Adherence Among Latino HIV-Positive Smokers
Official title: Improving Nicotine Patch Adherence Among Latino HIV-Positive Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
Keywords: Smoking
HIV
Latino
Cessation
Nicotine patch
Lead sponsor: RAND
Sponsor class: OTHER
First posted: 2014-07-15
Enrollment: 40
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: The goal of this study is to evaluate a smoking cessation program for Latino HIV-positive smokers focused on improving adherence to using the nicotine skin patch.


Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Latino
* HIV positive
* current, daily smoker
* ready to set quit date in next 30 days
* willing to try the nicotine patch

Exclusion Criteria:

* suffering from any medical condition which would prevent using the nicotine patch
* currently using other tobacco products or e-cigarettes
* currently receiving counseling or medication to quit or reduce smoking

Primary outcomes:
measure: Continuous abstinence
timeFrame: 3 months post-quit date
measure: biochemically-verified 7-day point prevalence abstinence
timeFrame: 3 months post-quit date
Secondary outcomes:
measure: Nicotine patch adherence
timeFrame: 3 months post-quit date
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Bienestar Human Services Inc
state: California
Study officials:
References:
Clinical trial NCT04192643: INTERVENTION WITH TRANEXAMIC ACID TO REDUCE HAEMORRHAGE DURING LAPAROSCOPIC MYOMECTOMY
Official title: THE IMPACT OF TRANEXAMIC ACID USAGE DURING LAPAROSCOPIC MYOMECTOMY
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Uterine Fibroid
Myoma;Uterus
Tranexamic Acid Adverse Reaction
Keywords: uterin fibroid, laparoscopic myomectomy
Lead sponsor: Alkü Alanya Education and Research Hospital
Sponsor class: OTHER
First posted: 2019-12-10
Enrollment: 60
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: PROSPECTİVELY DOUBLE-BLİND RANDOMİSED CONTROLLED TRİAL
Primary purpose: PREVENTION

Brief summary: This research is planned as a randomised double-blind controlled trial. interventions to reduce haemorrhage during laparoscopic myomectomy for fiboids is important. İntraoperative Tranexamic acid usage can reduce haemorrhage and related symptoms when given during laparoscopic myomectomy. There is no randomised controlled trials in literature about tranexamic acid usage in laparoscopic gynecological operations.

Detailed description: researchers planned this trial by firstly randomising the patients. 1 gr tranexamic acid in 100 ml salin will bi given by initial of the anesthesia of the patient, the other group will be taken only 100ml saline solution. Randomising will be double blind and only anesthesiologist will see if the paient is in working group or control group. Than researchers provide laparoscopic myomectomy with same prothocol to each patient. At the end of the operation, researchers will record all the parameters during operation like; operation starting and ending time, the amount of bleeding, time of suturing, the size, location and count of myoma uteri, complications, weight of myoma uteri and the change of haemoglobine levels before and after operation.

Eligibility criteria: Inclusion Criteria:

* myoma uteri
* appropiate for laparoscopy

Exclusion Criteria:

* malignancy

Primary outcomes:
measure: amount of bleeding during operation
timeFrame: 0 minute - 180 minute
measure: operation duration time
timeFrame: 0 minute - 180 minute
Secondary outcomes:
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Alku Alanya Education and Research Hospital
Study officials:
References:
Clinical trial NCT00693043: Pilot Study About Safety and Efficacy of Atomized Intrapleural Lidocaine During Pleuroscopy
Official title: A Pilot Study About Safety and Efficacy of Atomized Intrapleural Lidocaine During Pleuroscopy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Pain
Keywords: Pain control
Lead sponsor: Lahey Clinic
Sponsor class: OTHER
First posted: 2008-06-06
Enrollment: 0
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: SUPPORTIVE_CARE

Brief summary: This study will evaluate the potential to decrease the use of IV anesthesia drugs in patients undergoing pleuroscopy administering lidocane standardly applied to the skin in combination with atomized lidocaine applied into the pleural cavity.

Detailed description: Most patient discomfort results from direct manipulation or contact with the parietal pleura during chest tube placement, talc instillation or pleural biopsy. This study intends to use combined IV, intradermal and intrapleural anesthesia during pleuroscopy procedures. Intrapleural atomized lidocaine will be applied directly to the parital pleura. This study will evaluate intravenous anesthesia reduction in subjects treated with intrapleural lidocaine, reduction in total procedure timeby minimizing interruptions due to poor pain control, reduce perioperative pain scores and improve patient comfort nad to determine safety of fixed dosage of 3 mg/kg intrapleural lidocaine given during pleuroscopy.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with pleural disease
* Patients undergoing pleuroscopy with talc with or w/o biopsy
* Patients aged 18 - 85
* Patients capable of signing informed consent

Exclusion Criteria:

* Severe congestive heart failure
* Hepatic failure, bilirubin \> 2mg/dl, ALT,AST 3XULN
* Prior use Lidocaine in 48 hrs
* Hx SA drug reaction to lidocaine or amide local anesthetics
* Second or third degree heart block (w/o pacemaker)
* Sever sinoatrial block (w/o pacemaker)
* Concurrent treatment with quinidine, flecainide, dsopyramide, procainamide (ClassI antirrhythmic agents)
* Prior use or amiodarone hydrochloride
* systolic BP \< 90mmHg
* bradycardia
* accelerated idioventricular rhythm

Primary outcomes:
measure: Improve pain management in patients undergoing pleuroscopy
timeFrame: pre-procedure and post procedure
Secondary outcomes:
measure: Reduction of procedure time Measurement of lidocaine serum levels at 30, 60, 120
timeFrame: time of procedure will be documented;lidocaine levels monitored throught out
Other outcomes:
Locations:
city: Burlington
country: United States
facility: Lahey Clinic
state: Massachusetts
Study officials:
affiliation: Lahey Clinic
name: David R Riker, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03762538: The Effect of the ALDH2 Gene Polymorphism on the Propofol Potency for Inducing Loss of Consciousness
Official title: The Effect of the ALDH2 Gene Polymorphism on the Propofol Potency for Inducing Loss of Consciousness in Cardiac Patients: a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Propofol
Keywords: propofol
ALDH2
potency
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2018-12-03
Enrollment: 100
Sex: MALE
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: operation rooms for cardiac surgeries in our institution（a major hospital in China)

Brief summary: The aim of this study is to determine whether ALDH2 gene polymorphisms (G/G, G/A A/A) have effect on the potency of propofol.


Eligibility criteria: Inclusion Criteria:

* ASA II

Exclusion Criteria:

* ASA III-IV
* OSAS
* hepatic and renal insufficiency

Primary outcomes:
measure: Effect-site concentration
timeFrame: immediately after patient lose his/her consciousness
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01959243: Safety of Brimonidine Tartrate Ophthalmic Solution in a Population of Pediatric, Adult, and Geriatric Participants
Official title: A Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Study Evaluating the Safety of Brimonidine Tartrate Ophthalmic Solution 0.025% Used Four Times Daily in a Population of Pediatric, Adult, and Geriatric Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hyperemia
Keywords: Ocular redness
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
Collaborators: name: ORA, Inc.
First posted: 2013-10-09
Enrollment: 507
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: To compare the safety and tolerability of brimonidine tartrate ophthalmic solution 0.025% versus its vehicle in a population of pediatric, adult, and geriatric participants. At least 51% of participants will be 40 years of age or older.


Eligibility criteria: Inclusion Criteria:

* Participants must be at least 5 years of age at Baseline (Visit 1) of either sex and any race or ethnicity;
* Have ocular health within normal limits, including a calculated best-corrected (if necessary) visual acuity of 0.3 logarithm of the minimum angle of resolution (logMAR) or better in each eye, as measured using an Early Treatment of Diabetic Retinopathy Study (ETDRS) chart.

Exclusion Criteria:

* Have any ocular/systemic health problems
* Use of any disallowed medications during the period indicated prior to Baseline (Visit 1) and for the duration of the study.

Primary outcomes:
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
timeFrame: Baseline up to Day 29
Secondary outcomes:
measure: Drop Comfort Assessment as Assessed by the Participant
timeFrame: At dose installation, 30 seconds postdose installation, and 1 minute postdose installation on Day 1
measure: Number of Participants Who Were Fully Alert as Assessed by the Investigator on Days 1, 8, 15, and 29
timeFrame: Predose installation on Day 1 and 90-180 minutes postdose installation on Days 1, 8, 15, and 29
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Bausch Site 3
state: Arizona
city: Havre De Grace
country: United States
facility: Bausch Site 4
state: Maryland
city: Andover
country: United States
facility: Bausch Site 1
state: Massachusetts
city: Philadelphia
country: United States
facility: Bausch Site 2
state: Pennsylvania
Study officials:
affiliation: Bausch & Lomb Incorporated
name: Heleen DeCory
role: STUDY_DIRECTOR
References: