louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01035346: Study Evaluating The Efficacy Of A Novel Ibuprofen Formulation On Fever In Patients With An Uncomplicated Acute Infection
Official title: Evaluation Of The Antipyretic Efficacy Of Ibuprofen Sodium Tablets In Subjects With An Uncomplicated Acute Infection
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Infection
Keywords: Fever
antipyretic
uncomplicated acute viral infection
uncomplicated acute bacterial infections
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-12-18
Enrollment: 16
Sex: ALL
Minimum age (years): 12
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This single-dose trial will evaluate the efficacy of a novel ibuprofen formulation compared to placebo in patients with a fever due to an uncomplicated acute infection.


Eligibility criteria: Inclusion Criteria:

* Subjects diagnosed with a fever secondary to an uncomplicated acute viral or bacterial infection.
* Oral temperature measurement from 100 to 104 degrees Fahrenheit.
* Onset of fever 3 days or less.
* Otherwise good health.

Exclusion Criteria:

* Fever secondary to a chronic underlying medical condition or serious infection.
* Currently taking antibiotics or antivirals.
* Currently taking any medication which may interfere with the assessment of fever.
* Pregnancy or breast-feeding.
* Any serious medical or psychiatric disorder.

Primary outcomes:
measure: Time-weighted Sum of The Temperature Differences From Baseline Through Hour 6 (STEMPD 0-6)
timeFrame: 0 to 6 hours
Secondary outcomes:
measure: Time-weighted Sum of The Temperature Differences From Baseline Through Hour 4 and Hour 8 (STEMPD 0-4 and STEMPD 0-8)
timeFrame: 0 to 4, 0 to 8 hours
measure: Change From Baseline in Temperature at Hours 0.25, 0.5, 1, 2, 4, 6 and 8
timeFrame: Baseline, 0.25, 0.5, 1, 2, 4, 6, 8 hours
measure: Time to Treatment Failure
timeFrame: 0 to 8 hours
measure: Cumulative Percentage of Participants With Treatment Failure
timeFrame: 0.25, 0.5, 1, 2, 4, 6, 8 hours
measure: Global Assessment of Study Medication as an Antipyretic
timeFrame: 8 hours
measure: Rating of Study Medication Relative to Usual Medication
timeFrame: 8 hours
Other outcomes:
Locations:
city: Cypress
country: United States
facility: Pfizer Investigational Site
state: California
city: Westlake Village
country: United States
facility: Pfizer Investigational Site
state: California
city: Omaha
country: United States
facility: Pfizer Investigational Site
state: Nebraska
city: Pittsburgh
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Salt Lake City
country: United States
facility: Pfizer Investigational Site
state: Utah
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Jayawardena S, Leyva R, Kellstein D. Safety of a novel formulation of ibuprofen sodium compared with standard ibuprofen and placebo. Postgrad Med. 2015 Jan;127(1):33-7. doi: 10.1080/00325481.2015.993268. Epub 2014 Dec 15.
Clinical trial NCT05398146: The Effect of Three Methods Used in Reducing Pain During Dressing Change
Official title: The Effect of Listening to Music, Performing Mathematics Operations and Ball Squeezing in Reducing Pain During Dressing Change in Children With Appendectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: pain
appendectomy
child
distraction
dressing
Lead sponsor: Okan University
Sponsor class: OTHER
Collaborators: name: Kanuni Sultan Suleyman Training and Research Hospital
First posted: 2022-05-31
Enrollment: 30
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This randomized controlled study aims to determine the effect of listening to music (LM), ball squeezing (BS), and performing mathematical operations (MO) in reducing the pain experienced during the first dressing in children aged 8-18 with appendectomy.

Detailed description: The sample of the study consisted of 120 children (LM:30, BS:30, MO:30, control:30). A minute before dressing and during dressing, the children in the LM group listened to music, the children in the SB group squeezed the ball, the children in the MO group performed mathematical operations.According to the child, parent, and nurse assessment, it was determined that the mean pain score of the children in the LM and MO groups was lower than that of the BS group and control groups (p\< .05).

Eligibility criteria: Inclusion Criteria:

* Consisted of the child and parent's consent to participate in the study,
* The child and parent's speaking Turkish at the level of native speaker,
* The child's being 8-18 years old and undergoing appendectomy,
* Being the body temperature of the child in the normal level (36.5-37.2⁰C),
* The child's not having intense nausea and vomiting,
* The child's not having any physical, intellectual or neurological disability that would affect his/her participation.

Exclusion Criteria:

* Having a mental or neurological disability
* Children with hearing and vision impairment

Primary outcomes:
measure: Comparison of Pain Scores pre-dressing
timeFrame: 60 seconds
measure: Comparison of Pain Scores During Dressing
timeFrame: 60 seconds
measure: Comparison of Pain Scores post-Dressing
timeFrame: 60 seconds
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University-Cerrahpasa
Study officials:
affiliation: Istanbul University - Cerrahpasa
name: birsen mutlu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03385746: Retention of Metal Reinforced Polyamide Denture Base and Heat Cured Acrylic Resin Denture Base in Complete Mandibular Denture
Official title: Evaluation of Retention of Metal Reinforced Polyamide Denture Base Compared to Conventional Heat Cured Acrylic Resin Denture Base in Complete Mandibular Denture
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anodontia of Permanent Dentition
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-12-28
Enrollment: 12
Sex: ALL
Minimum age (years): 55
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The trial is done in order to reinforce polyamide to improve its modulus of elasticity to be able to use it as a denture base material in all clinical cases


Eligibility criteria: Inclusion Criteria:

1. Male or female patient with age range from fifty five to sixty five completely edentulous and in good medical condition
2. Patients have skeletal Angle's class I maxillo-mandibular relationship and sufficient inter arch distance.
3. Free from any systemic or neuromuscular disorder that might affect chewing efficiency of masticatory muscles.
4. Free from any tempro-mandibular disease.
5. Good oral hygiene.

Exclusion Criteria:

1. Neuromuscular disorder and orofacial disease.
2. Tempromandibular joint and muscle pain
3. xerostomia or excessive salivation.
4. Limited mouth opening

Primary outcomes:
measure: Retention assessed by digital forcemeter
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Vojdani M, Giti R. Polyamide as a Denture Base Material: A Literature Review. J Dent (Shiraz). 2015 Mar;16(1 Suppl):1-9.
citation: Soygun K, Bolayir G, Boztug A. Mechanical and thermal properties of polyamide versus reinforced PMMA denture base materials. J Adv Prosthodont. 2013 May;5(2):153-60. doi: 10.4047/jap.2013.5.2.153. Epub 2013 May 30.
Clinical trial NCT04440046: Real Versus Sham Manual Therapy for RCRSP
Official title: Real Versus Sham Manual Therapy in Addition to Therapeutic Exercise in the Treatment of Rotator Cuff Related Shoulder Pain: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder Pain
Lead sponsor: University of Alcala
Sponsor class: OTHER
First posted: 2020-06-19
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A convenience sample of subjects with RCRSP recruited through announcements at the Benemerita Universidad Autonoma de Puebla will be treated with an exercise program with sham or real manual therapy for 5 weeks.

The hypothesis of the present study is that the addition of manual therapy to a therapeutic exercise program produces better benefits in comparison to the same exercise program with sham manual therapy procedures in the management of patients with RCRSP.

Detailed description: The objective of this study is to demonstrate that the combination of manual therapy and therapeutic exercise achieves better results in the management of the patient with shoulder pain.

For this, manual therapy techniques in the thoracic region and in the shoulder together with a therapeutic exercise program will be applied.

The investigators will compare this intervention protocol with placebo manual therapy techniques and the same therapeutic exercise protocol.

Eligibility criteria: Inclusion Criteria:

* unilateral shoulder pain of non-traumatic origing lasting more than three months.
* Pain evoked with active shoulder movements.
* Pain and weakness evoked with manual muscle strength tests for abduction and/or external rotation.
* Minimal or no rest pain (less than 3 points in a numeric pain rating scale).

Exclusion Criteria:

* Other shoulder pathologies than RCRSP.
* Systemic diseases.
* Neural symptoms.
* Neck pain.
* Radiculopathy.
* To have been treated for shoulder pain in the last three months.

Primary outcomes:
measure: Shoulder Pain and Disability Index (SPADI)
timeFrame: Change from Baseline at 17- week
Secondary outcomes:
measure: Pain intensity measured with a visual analogue scale
timeFrame: Change from Baseline at 17-week
measure: Pain-free range of movement of the shoulder
timeFrame: Change from Baseline at 17-week
Other outcomes:
Locations:
city: Alcalá De Henares
country: Spain
facility: Ruben Fernandez-Matias
Study officials:
affiliation: University of Alcala
name: Daniel Pecos-Martin, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00867646: Comparison Study of CoaguChek XS PT and Laboratory Innovin PT by NTUH Lab Medicine
Official title: Comparison Study of CoaguChek XS Prothrombin Time and Laboratory Innovin PT by NTUH Lab Medicine
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Deep Vein Thrombosis
Keywords: PT
DVT
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2009-03-24
Enrollment: 70
Sex: ALL
Minimum age (years): 18
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: 70 Warfarin teated patients

Brief summary: Comparison Study of CoaguChek XS PT and Laboratory Innovin PT by NTUH Lab Medicine

Detailed description: This trial is going to proceed in two phases: Familiarization Phase and Evaluation Phase. The Preliminary Comparison Study consists of ten (10) patients being tested with the CoaguChek system and the laboratory reference method. This preliminary study is intended to help familiarize the operator with the dosing of the CoaguChek XS PT strips and to serve as an indicator as to whether some of the variables. Evaluation Phase consists of testing seventy (70) patient samples with the CoaguChek XS system and with the laboratory method.

Eligibility criteria: Inclusion Criteria:

* Warfarin continuously treated patients

Exclusion Criteria:

* Warfarin recently discontinuous treatment

Primary outcomes:
measure: Comparison of the PTINR measured by Coaguchek and laboratory CA1500
timeFrame: 2 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Chiang Fu-Tien, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02051946: Novel Drug Delivery Technique Via Retroject Device
Official title: Novel Drug Delivery Technique for Glaucoma Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Glaucoma
Keywords: novel drug delivery technique for glaucoma patients
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2014-01-31
Enrollment: 9
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to identify whether or not injection of a study drug (ethacrynic acid) using the investigational Retroject device is able to lower eye pressures in patients with advanced glaucoma. 20 patients with advanced glaucoma with visual acuity less than 20/200 and intraocular pressures (IOP) \>20mmHg on maximum medical therapy will be asked to participate in the study. The first five patients will have the Retroject device placed over their eye for 30 seconds and then removed. Assuming no issues, then it will be placed on the eye for one minute. The second group of patients (3 total) will have the Retroject device placed on the eye and then an injection of ethacrynic acid into the episcleral vein. The third group of patients (12 total) will have the Retroject device placed on the eye and then will be randomized in a 2:1 ratio to receive either an ethacrynic acid injection or a balanced salt solution injection. All 20 patients will then return for intraocular pressure measurements on days 1, 2, 3, and 7 as well as 6 weeks after injection. In addition, the patients will undergo pre and post intervention corneal endothelial assessments (endothelial cell count, shape analysis, and pachymetry). Potential safety issues are unlikely and include bleeding, infection, pain, ototoxicity, or temporary or permanent loss of vision.


Eligibility criteria: Inclusion Criteria:

* age 55 years or older of both sexes
* IOP \>20 mmHg on maximal treatment
* \<20/200 visual acuity
* willing to sign informed consent forms

Exclusion Criteria:

* monocular patients with bleeding disorders
* patients on anticoagulant or antiplatelet medications
* patients who had prior laser surgeries (SLT or ALT)

Primary outcomes:
measure: Change in Intraocular pressures (IOP) lowering effect
timeFrame: Days 1, 2, 3, and 7, and 6 weeks after injection
Secondary outcomes:
Other outcomes:
measure: Corneal endothelial cell counts
timeFrame: 6 weeks after injection
Locations:
city: Durham
country: United States
facility: Duke University Eye Center
state: North Carolina
Study officials:
affiliation: Duke University Eye Center
name: Rand Allingham, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02198846: A Study to Compare Insulin Pump With Conventional Treatment in Type 2 Diabetes
Official title: A Study to Compare the Efficacy and Safety of Insulin Pump Treatment in Patients With Uncontrolled Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Konkuk University Medical Center
Sponsor class: OTHER
First posted: 2014-07-24
Enrollment: 140
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: Insulin deficiency resulted from progressive beta cell failure and insulin resistance in type 2 diabetes requires exogenous insulin therapy, escaping from oral antihyperglycemic agents. Previous data have been suggested that continuous subcutaneous insulin infusion (CSII) does not only have efficacy in glucose control but also restore beta cell failure.

The investigators plan to compare the efficacy/safety and beta cell function between insulin pump treatment and the intensification of conventional treatment in patients with uncontrolled type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes
* age: 18 \~ 85 yrs
* HbA1c: \> 7.5%
* no change of anti-diabetic medication within 3 months

Exclusion Criteria:

* systemic corticosteroid administered within previous 6 months
* pregnancy
* severe liver or renal disease, heart failure
* History of cancer within 5 years
* Thyroid disease
* Anti-obesity drugs or slimming products within previous 3 months

Primary outcomes:
measure: change of HbA1c
timeFrame: 24 weeks
Secondary outcomes:
measure: changes of body weight
timeFrame: 24 weeks
measure: frequency of hypoglycemia
timeFrame: 24 weeks
measure: change of beta cell function
timeFrame: 24 weeks
measure: Percent of patients who reach target goal of HbA1c (<7.0%)
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Chungju
country: Korea, Republic of
facility: Konkuk University Chungju Hospital
Study officials:
affiliation: Konkuk University
name: Soo Bong Choi, MD.PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06607146: Assessing the Effect of Computer-based Auditory Training on Adult Cochlear Implant Speech and Quality-of-life Outcomes
Official title: Assessing the Effect of Computer-based Auditory Training on Adult Cochlear Implant Speech and Quality-of-life Outcomes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cochlear Implants
Bilateral Sensorineural Hearing Loss
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2024-09-23
Enrollment: 80
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 purpose of this study is to compare the effectiveness of a free computer-based auditory training program, Sound Success (Advanced Bionics, Valencia, CA), with the current standard of care of patient-directed auditory training in improving common measures of speech recognition and cochlear implant (CI) specific quality-of-life in new adult CI recipients in their first year post-activation.


Eligibility criteria: Inclusion Criteria:

* Adult patients with a diagnosis of bilateral moderate-to-profound sensorineural hearing loss who are undergoing unilateral or simultaneous bilateral cochlear implantation at the Mayo Clinic in Rochester MN.

Exclusion Criteria:

* Patients undergoing revision implantation, completion bilateral cochlear implantation, or implantation for unilateral deafness will be excluded from enrollment
* Patients unable or unwilling to use a computer or similar device will be excluded from enrollment.
* Patients will be excluded if they speak a language not supported by the Sound Success platform. Sound Success is available in English, Spanish, French, Italian, Dutch, Polish, and Danish.

Primary outcomes:
measure: Change in Cochlear Implant Quality of Life-35 Profile
timeFrame: Baseline, 3 months, 6 months, 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Matthew Carlson, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03541746: The Value of Using Platelet Rich Plasma After Hysteroscopic Lysis of Severe Intrauterine Adhesions
Official title: The Value of Using Platelet Rich Plasma After Hysteroscopic Lysis of Severe Intrauterine Adhesions (A Randomized Controlled Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intrauterine Adhesion
Lead sponsor: Ain Shams Maternity Hospital
Sponsor class: OTHER
First posted: 2018-05-31
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 43
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of present study is to evaluate the effect of the use of platelet rich plasma in decreasing recurrence of intrauterine adhesions after its lysis.

Detailed description: Research question:

In women undergoing hysteroscopic adhesiolysis, does postoperative use of platelet rich plasma decrease the recurrence of intrauterine adhesions?

Research hypothesis:

In women undergoing hysteroscopic adhesiolysis for Asherman's syndrome, postoperative use of platelet rich plasma may decrease the recurrence of intrauterine adhesions.

Eligibility criteria: Inclusion Criteria:

* Infertility due to Asherman's syndrome with history of hypomenorrhea or amenorrhea and infertility and evaluated by office hysteroscopy to confirm the presence of sever adhesions according to American fertility society.

Exclusion Criteria:

* Hb \< 11 g/dL, platelets \< 150.000/mm3
* Patient taking anticoagulant.
* Patient taking NSAID in the 10 days before procedure.
* Any significant comorbidity or psychiatric disorder that would compromise patient's consent.
* Active cervical or uterine infection.

Primary outcomes:
measure: Prevent recurrence of intrauterine adhesions
timeFrame: Reassessed after one month
Secondary outcomes:
measure: Return of menses
timeFrame: Reassessed after one month
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University Maternity Hospital
Study officials:
affiliation: Professor
name: Mohamed I Amer, MD
role: STUDY_CHAIR
affiliation: Lecturer
name: Mortada E Ahmed, MD
role: STUDY_DIRECTOR
affiliation: Lecturer
name: Reda M Kamal, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06208046: Predict 5-Year Survival in Elderly Gastric Cancer
Official title: Machine Learning Models to Predict 5-Year Post-Surgery Survival of Older Gastric Cancer Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric Cancer
Machine Learning
Keywords: Gastric Cancer
Elderly
Oxidative Stress
Machine Learning
Overall Survival
Lead sponsor: Fujian Medical University
Sponsor class: OTHER
Collaborators: name: Fujian Medical University Union Hospital
First posted: 2024-01-17
Enrollment: 2187
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This retrospective prognostic study encompassed patients aged 65 or older who underwent radical gastrectomy for GC from January 2012 to April 2018. The study involved a derivation cohort and an external validation cohort.

Brief summary: In this study, elderly patients with gastric cancer who underwent radical gastrectomy in Union Hospital Affiliated to Fujian Medical University from 2012 to 2018 were included as a derived cohort, and the training set and internal validation set were randomly divided by 4:1. Machine learning strategies of random forest, decision tree and support vector machine are used to construct survival prediction model. Each model was tested in an internal validation set and an external validation set consisting of patients from two other large medical centers.

Detailed description: This is a retrospective, supervised learning, data mining study.

Eligibility criteria: Inclusion Criteria:

* (1) GC diagnosis confirmed by abdominal computed tomography (CT) or biopsy; (2) age ≥65 years at diagnosis; (3) underwent radical surgical resection without evidence of distant metastasis; and (4) availability of complete clinical and pathological data.

Exclusion Criteria:

* (1) postoperative pathology confirming non-gastric primary tumors; (2) distant metastasis; (3) incomplete clinical data; and (4) other concurrent malignancies within five years.

Primary outcomes:
measure: 5-year overall survival
timeFrame: 5 years or 60 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
Study officials:
affiliation: Fujian Medical University Union Hospital
name: Huang Chang-Ming, Prof.
role: PRINCIPAL_INVESTIGATOR
References: