louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03365869: A Pilot-Study of Sirolimus for the Treatment of Systemic Sclerosis
Official title: A Phase Ⅱ Pilot-Study With Sirolimus for the Treatment of Systemic Sclerosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Systemic Sclerosis
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2017-12-07
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to examine the safety and effectiveness of sirolimus treatment for people with systemic sclerosis.

The investigators perform a multi-centre, double-blind pilot trial with sirolimus in SSc.The investigators evaluate the effectiveness and safeness of sirolimus for Systemic Sclerosis by randomized controlled study (sirolimus 2mg/d (N = 36) versus placebo group (N = 36)).

Detailed description: Each SSc patients (n=72) received sirolimus or placebo (active group: placebo group =1:1, 2mg/day， oral administration, (SIR 2mg, po., Qd) .

The end points were the changement of modified RSS and the adverse events or severe adverse events onset.

Eligibility criteria: Inclusion Criteria:

* Meet the American College of Rheumatology criteria for the diagnosis of SSc, 2013.
* Disease duration less than 5 years.
* mRSS was under stable level (\>1 month) at the time inclusion.
* Negative urine pregnancy test
* Written informed consent form

Exclusion Criteria:

* Diagnosed with localized scleroderma .
* Added with immunosuppressor in one month such as MTX, AZA, CYC.
* Added with anti-fibosis drug in one month.
* Prednisone \>10mg QD before inclusion.
* Sever chronic liver, kidney, lung or heart dysfunction; (heart failure (≥ grade III NYHA), hepatic insufficiency (transaminases\> 3N) )
* Serious infection such as bacteremia, sepsis
* Mental disorder or any other chronic illness or drug-abuse that could interfere with the ability to comply with the protocol or to give information
* Cancer or history of cancer cured for less than five years (except in situ carcinoma of the cervix or Basocellular carcinoma)
* Positive HIV test
* Positive urine pregnancy test
* Combined with the other connective tissue diseases

Primary outcomes:
measure: Number of participants whose modified Rodnan skin score （mRSS）decreasing
timeFrame: week 48
Secondary outcomes:
measure: The number of adverse event and severe adverse event occured
timeFrame: week 48
Other outcomes:
Locations:
Study officials:
affiliation: Peking University Institute of Rheumatology and Immunology
name: Mu Rong, Poster
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03623269: Posterior Approach to Total Shoulder Arthroplasty
Official title: Posterior Approach to Total Shoulder Arthroplasty: A Data Analysis on Patients Undergoing the Posterior Approach to Total Shoulder Arthroplasty
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Total Shoulder Arthroplasty
Osteo Arthritis Shoulders
Lead sponsor: The Orthopaedic Research & Innovation Foundation
Sponsor class: OTHER
First posted: 2018-08-09
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All eligible patients of the principal investigator receiving the posterior approach to total shoulder arthroplasty for any indication at our institution between September 1, 2016 and October 31, 2017 were evaluated and included in the data analysis.

Brief summary: The purpose of this study is to evaluate preoperative objective measurements and operative objective measurements to determine if there is any effect to postoperative outcomes. Patients who were 18 years old or greater at the time of surgery were followed clinically and radiographically to determine best practice and optimal treatment and technique, risk and rate of complication, and postoperative outcomes.


Eligibility criteria: Inclusion Criteria:

1. English speaking
2. \>18 years of age
3. Underwent posterior approach to total shoulder arthroplasty by Dr. Michael Greiwe at St. Elizabeth Healthcare

Exclusion Criteria:

1. Non-English speaking
2. \<18 years of age
3. Loose bone in the anterior recess of the shoulder
4. Severe arthritis with significant bony deformity

Primary outcomes:
measure: recovery
timeFrame: preoperative to 6 months postoperatively
measure: recovery
timeFrame: preoperative to 6 months postoperatively
measure: recovery
timeFrame: preoperative to 6 months postoperatively
measure: complications
timeFrame: 6 months postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Edgewood
country: United States
facility: The Orthopaedic Research & Innovation Foundation
state: Kentucky
Study officials:
affiliation: The Orthopaedic Research & Innovation Foundation
name: R M Greiwe, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00473369: Prognosis of Atypical Pituitary Adenomas
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pituitary Diseases
Keywords: atypical adenoma
Ki-67
p53
pituitary
prognosis
Lead sponsor: Tohoku University
Sponsor class: OTHER
First posted: 2007-05-15
Sex: ALL
Minimum age (years): 12
Maximum age (years): 74
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: OTHER

Brief summary: Context: Pituitary adenoma is generally indolent, but an aggressive subtype called atypical adenoma has uncertain prognosis, and an unclear relationship between prognosis and morphology.

Objective: This study investigated the prognostic factors of this tumor. Design: Retrospective analysis. Setting: University and associated hospitals.


Eligibility criteria: Inclusion Criteria:

* pituitary adenomas of more than 3 % of Ki67 labeling index surgically treated at Tohoku university and associated hospital

Exclusion Criteria:

* pituitary adenomas of less than 3 % of Ki-67 labeling index surgically treated at Tohoku university and associated hospital

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Department of neurosurgery, Tohoku university
name: Yoshikazu Ogawa, M. D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01043068: The Effect of Cancer Pain Management Protocol on Hospitalized Cancer Patients: A Pilot Study
Official title: A Pilot Study: The Effect of Cancer Pain Management Protocol on Hospitalized Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cancers, Pain
Keywords: cancer pain
opioid
guideline
Lead sponsor: National Cancer Center, Korea
Sponsor class: OTHER_GOV
Collaborators: name: Janssen Korea, Ltd., Korea
First posted: 2010-01-06
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study was to prospectively evaluate the effect of cancer pain management protocol on hospitalized cancer patients.


Eligibility criteria: Inclusion Criteria:

* Hospitalized patient with the somatic and/or visceral pain having an untreated intensity greater than 3 on a 10 cm visual analog scale (VAS; 0 = no pain, 10 = unbearable pain)over the week prior to enrollment
* A minimum age of 18 years

Exclusion Criteria:

* Opioid intolerance
* No longer treatment for their underlying disease.
* Intracerebral primary or metastatic lesion
* Impaired sensory or cognitive function
* Pregnant or lactating woman
* Women of child bearing potential not using a contraceptive method
* Sexually active fertile men not using effective birth control during medication of study drug and up to 6 months after completion of study drug if their partners are women of child-bearing potential
* Any patients judged by the investigator to be unfit to participate in the study

Primary outcomes:
measure: Reduction in pain scores
timeFrame: Jan 2010 - October 2010
Secondary outcomes:
Other outcomes:
Locations:
city: Goyang
country: Korea, Republic of
facility: National Cancer Center
state: Gyeonggi-do
Study officials:
affiliation: National Cancer Center, Korea
name: Dae Hyun Kim, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05019768: Topo-pachimetric Accelerated Epi-On Cross-linking Compared to Dresden Protocol Using Riboflavin With Vitamin E TPGS
Official title: Topo-pachimetric Accelerated Epi-On Cross-linking Compared to Dresden Protocol Using Riboflavin With Vitamin E TPGS: Results of a 2-year Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Keratoconus
Lead sponsor: Corneal Transplant Center, Pellegrini Hospital
Sponsor class: OTHER
First posted: 2021-08-25
Enrollment: 41
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: In the present study the investigators compare the clinical outcome corneal cross linking with either the stand-ard Dresden (sCXL) or the accelerated custom-fast (aCFXL) ultraviolet A irradiation protocol using riboflavin-D-α-Tocopheryl polyethyleneglycol1000 succinate for progressive keratoconus.


Eligibility criteria: Inclusion Criteria:

* documented progressive keratoconus
* changes in uncorrected distance visual acuity (UDVA) above 1.00 D
* Corrected distance visual acuity (BCVA) above 1.00 D
* spherical equivalent greater than 0.50 D

Exclusion Criteria:

* Corneal pachymetry of less than 400 µm
* less than 2000 cells/cm2,
* corneal scarring,
* nystagmus or any motility disorder that prevented a fixed gaze during the examination
* Current contact lens use

Primary outcomes:
measure: Topographical parameters
timeFrame: 2 years
Secondary outcomes:
measure: Refractive parameters
timeFrame: 2 years
measure: Refractive parameters
timeFrame: 2 years
measure: Biomechanical parameters
timeFrame: 2 years
Other outcomes:
Locations:
city: Napoli
country: Italy
facility: Pellegrini Hospital
Study officials:
References:
citation: Caruso C, Ostacolo C, Epstein RL, Barbaro G, Troisi S, Capobianco D. Transepithelial Corneal Cross-Linking With Vitamin E-Enhanced Riboflavin Solution and Abbreviated, Low-Dose UV-A: 24-Month Clinical Outcomes. Cornea. 2016 Feb;35(2):145-50. doi: 10.1097/ICO.0000000000000699.
citation: Caruso C, Epstein RL, Ostacolo C, Pacente L, Troisi S, Barbaro G. Customized Corneal Cross-Linking-A Mathematical Model. Cornea. 2017 May;36(5):600-604. doi: 10.1097/ICO.0000000000001160.
Clinical trial NCT06140368: Virtual Realityon Pain, Anxiety and Comfort During Trigger Point Injection
Official title: The Effect of Virtual Reality on Pain, Anxiety and Patient Comfort During Trigger Point Injection
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Virtual Reality
Keywords: virtual reality
pain
trigger point injection.
anxiety
comfort
Lead sponsor: Izmir Bakircay University
Sponsor class: OTHER
First posted: 2023-11-20
Enrollment: 100
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: SUPPORTIVE_CARE

Brief summary: To determine the effects of virtual reality application during trigger point injection on patients' pain, anxiety and comfort levels.This research was planned as a randomized controlled experimental type. The population of the research was planned to include patients who applied to the Algology polyclinic for trigger point injection. The sample of the research will consist of 150 patients who meet the sampling criteria and agree to participate in the research.Inclusion criteria: Trigger point injection applied for the first time, 18 years and over, understand and speak Turkish, understand verbal and written information given.Patients will be divided into two groups: experimental (virtual reality) and control groups.Data will be collected with the Case Report Form, State Anxiety Scale, General Comfort Scale and Visual Analog Scale.Patients' anxiety, comfort and pain levels will be evaluated before and after trigger point injection.

Detailed description: Patients in the experimental group will be shown videos that the patient wants to watch, such as nature and seaside walks, underwater videos, with music background, through virtual reality glasses for 10 minutes.Patients in the control group will continue routine practice.Patients' anxiety, comfort and pain levels will be evaluated before and after trigger point injection.

Eligibility criteria: Inclusion Criteria:

* The procedure will be applied for the first time

  * 18 years and over
  * Able to understand and speak Turkish
  * Able to understand verbal and written information given
  * Having good cognitive abilities
  * Without visual or hearing loss
  * Patients who agreed to participate in the study

Exclusion Criteria:

* Those who do not understand or speak Turkish
* Does not understand verbal and written information
* Those with impaired cognitive abilities
* Epilepsy

Primary outcomes:
measure: State Anxiety Scale
timeFrame: 10 minutes after procedure
measure: General Comfort Scale
timeFrame: 10 minutes after procedure
measure: Visual Analog Scale
timeFrame: In the middle (10 minutes) of the procedure
Secondary outcomes:
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Elif Günay İsmailoğlu
state: Menemen
Study officials:
affiliation: Izmir Bakircay University
name: Elif Günay İsmailoğlu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01527968: Epsilon Aminocaproic Acid Vs. Tranexamic Acid Vs. Placebo for Prevention of Blood Loss in Total Knee Arthroplasty
Official title: A Prospective, Randomized, Double Blind, Double-Dummy Study Comparing the Safety and Efficacy of Epsilon Aminocaproic Acid (eACA) Versus Tranexamic Acid (TXA) Versus Placebo for Prevention of Blood Loss in Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoarthritis
Lead sponsor: Heekin Orthopedic Research Institute
Sponsor class: OTHER
First posted: 2012-02-07
Enrollment: 54
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: TXA and EACA have been reported to reduce blood loss in cardiac and neuro surgery, but there is no literature available comparing the two in total knee arthroplasty (TKA). The investigators want to determine if TXA or EACA compared with placebo are effective and safe for blood loss prevention in TKA by comparing blood loss, transfusion rates, and total cost.


Eligibility criteria: Inclusion Criteria:

* All patients scheduled to receive primary unilateral total knee arthroplasty

Exclusion Criteria:

* Subject requires bilateral staged total knee arthroplasty
* Religious beliefs that would limit blood transfusion
* History of acquired defective color vision (inhibits monitoring for adverse events)
* Patients with a known history of upper urinary tract bleeding
* History of abnormal coagulation
* Renal dysfunction defined by elevated BUN and CR or BUN to CR ratio of 20:1 within 30 days of surgery
* Active intravascular clotting
* Known allergy to either TXA or eACA
* Myocardial Infarct within 6 months
* History of stroke
* Patient is a prisoner

Primary outcomes:
measure: Blood loss until the drain is removed
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Heekin Institute for Orthopedic Research
name: R. David Heekin, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05660668: Comparative Assessment of Failure Rate of Fixed Lingual Retainer Between Two Types of Light Cured Resin Composite
Official title: Comparative Assessment of Failure Rate of Fixed Lingual Retainer in Finished Orthodontic Cases Between Two Types of Light Cured Resin Composite. A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Orthodontic Retainer
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-12-21
Enrollment: 90
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will be performed on human subjects with finished orthodontic treatment to see the failure rate(detachment) of fixed lingual retainer between two types of light cure resin composite

Detailed description: The study consists of two groups, the intervention involve performing bonding of fixed lingual retainer with light cured composite Transbond LR which is manufactured specific for the fixed lingual retainer while the control group involve bonding of fixed lingual retainer by light cured composite Transbond XT with follow up every month for 6 month to see the failure rate(detachment) between the two types of composite

Eligibility criteria: Inclusion Criteria:

* Patient at the end of an orthodontic treatment requiring the subsequent application of a lingual and palatal fixed retainer
* good oral hygiene
* medically free

Exclusion Criteria:

* Facial trauma
* onychophagia
* habit of biting pencils or pens
* tooth mobility

Primary outcomes:
measure: Failure rate( detachment rate) of fixed lingual retainer
timeFrame: the patient will be inspected after applying the fixed retainer every month for 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo unversity ,Faculty of dentistry
Study officials:
affiliation: Cairo unversity
name: Fady Hussein, Assoc. prof
role: STUDY_DIRECTOR
References:
Clinical trial NCT03917368: Ultrasound Evaluation of the Jugular Venous Pulse (US-JVP)
Official title: Validation of a Novel Non-invasive Technique Based on Real-time Ultrasound B-mode to Assess the Jugular Venous Pulse
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Emergencies
Cardiovascular Diseases
Neurovascular Disorders
Keywords: Jugular Venous Pulse
Central Venous Pressure
Ultrasounds
Validation Studies
Software Validation
Lead sponsor: S. Anna Hospital
Sponsor class: OTHER
First posted: 2019-04-17
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The jugular venous pulse (JVP) reflects changes in the right atrial pressure and its evaluation can be useful in managing many emergency conditions for guiding the fluid administration as well as in the diagnosis and/or prognosis of many heart and lung diseases. The present study aims: i) To validate a novel ultrasonographic (US) technique for obtaining the JVP from a high-resolution B-mode sonograms sequence, recording the changes of the cross-sectional area (CSA) of the internal jugular veins (IJV) over the cardiac cycle; ii) To develop physical and mathematical models capable of providing an indirect estimate of central venous pressure (CVP) from the changes in IJV-CSA acquired through the US investigation, and iii) To test the transferability of the novel US-JVP technique in a clinical setting.

Detailed description: The study will be articulated in different phases, encompassing data collection, development of physical and mathematical models, statistical evaluations, and software implementation. The clinical experimental phase of the study (data collection) will involve hospitalized adult patients requiring a scheduled central venous catheterization and measurement of the CVP as part of their usual care. The latter will be used as the gold standard measure of CVP for the subsequent data processing and analysis. A small sample of healthy adult volunteers will also be recruited only for the non-invasive US evaluation of the JVP. The validation processes will include assessment of the diagnostic power of the US-JVP estimated CVP values and US-JVP waveforms, including evaluation of sensibility, specificity, predictive positive and negative values, accuracy and precision.

Eligibility criteria: Inclusion criteria:

* Adult (age ≥18 years) hospitalized patients, spontaneous breathing, requiring a scheduled central venous catheterization and measurement of the central venous pressure as part of their usual care;
* Capacity to give informed consent.

Exclusion criteria:

* Central venous catheterization via the internal jugular venous access

Primary outcomes:
measure: Jugular venous pulse by ultrasound
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Ferrara
country: Italy
facility: University Hospital of Ferrara
Study officials:
affiliation: University Hospital of Ferrara, Italy
name: Paolo Zamboni, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02577068: Combination Effect of Nefopam With Propacetamol for Postoperative Pain After Thyroidectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thyroidectomy
Pain
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2015-10-16
Enrollment: 84
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients undergoing thyroidectomy are suffering not only surgical wound pain but posterior neck pain because of neck extension position during the surgery. However, there has been little attention of posterior neck pain. Nefopam and Propacetamol have different pharmacodynamics and been used for postoperative pain control in thyroidectomy patients. The aim of this study is evaluation of combination effect of Nefopam and Propacetamol for acute wound pain, posterior neck pain and chronic pain after thyroidectomy.


Eligibility criteria: Inclusion Criteria:

* patient who undergone open thyroidectomy
* 20\~70 years old
* ASA I\~III

Exclusion Criteria:

* hypersensitivity on Nefopam and Propacetamol
* Liver failure, chronic alcohol addiction
* severe hemolytic anemia, chronic nutrition deficiency
* history of seizure
* MI, MAO inhibitor
* pregnant, breast-feeding
* foreigners

Primary outcomes:
measure: VAS score on wound site and posterior neck
timeFrame: one hour after the surgery
Secondary outcomes:
measure: Additional pain rescue drug
timeFrame: for postop. 24hrs.
measure: Postoperative nausea and vomiting
timeFrame: for postop. 24hrs.
measure: Patient satisfaction
timeFrame: for postop. 24hrs.
measure: Chronic pain and neurogenic pain
timeFrame: three month after the surgery.
measure: acute VAS on wound site and posterior neck
timeFrame: postop. 24hrs.
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
Study officials:
References:
citation: Han DW, Koo BN, Chung WY, Park CS, Kim SY, Palmer PP, Kim KJ. Preoperative greater occipital nerve block in total thyroidectomy patients can reduce postoperative occipital headache and posterior neck pain. Thyroid. 2006 Jun;16(6):599-603. doi: 10.1089/thy.2006.16.599.