louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01879449: Prevalence of Spasticity in Veterans Living in a Long-term Care Facility
Official title: Prevalence of Spasticity in Veterans Living in a Long-term Care Facility
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spasticity
Keywords: Spasticity
Veterans
Prevalence
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
Collaborators: name: Allergan
name: Merz North America, Inc.
First posted: 2013-06-17
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Nursing home residents

Brief summary: The purpose of the study is to conduct a feasibility survey of the prevalence of spasticity at a single long-term care facility for veterans and their spouses in Murfreesboro, Tennessee. These data will be used to strengthen a future grant application to the Department of Defense in response to their ongoing Traumatic Brain Injury initiative.

Detailed description: The goal of this feasibility survey is to determine the prevalence of spasticity that interferes with care or function at the Tennessee State Veterans Home (TSVH), which is a long-term care facility for veterans and their spouses in Murfreesboro, Tennessee. In order to accomplish this goal, each of the 140 residents will be examined by the principal investigator and a medical record review will be performed; also, each patient and their medical decision-maker (if applicable), direct caregiver, and treating physician will be surveyed in order to further elucidate the barriers to treatment in this population. All consenting residents of the TSVH will be examined, but the data will be separated prior to analysis based on whether the resident is a veteran or a veteran's relative.

Eligibility criteria: Inclusion Criteria:

* Male and female subjects of any race, aged 18 and above.
* Reside at the Tennessee State Veterans Home

Exclusion Criteria:

* Subjects for whom it is felt that participation in the study would cause medical harm

Primary outcomes:
measure: Spasticity diagnosis
timeFrame: Up to three months after consent is obtained
Secondary outcomes:
measure: Spasticity treatment awareness and preferences survey
timeFrame: Up to three months after consent is obtained
Other outcomes:
Locations:
city: Murfreesboro
country: United States
facility: Tennessee State Veterans Home
state: Tennessee
Study officials:
affiliation: Vanderbilt University
name: David Charles, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06524349: Utilization of a 3D Printed Customized Knee Extender and At-Home Rehabilitation Program on Patient Outcomes Following ACL Surgery
Official title: Utilization of a 3D Printed Customized Knee Extender and At-Home Rehabilitation Program on Patient Outcomes Following ACL Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anterior Cruciate Ligament Injuries
Anterior Cruciate Ligament Tear
Anterior Cruciate Ligament Rupture
Keywords: 3D printing
knee extender device
Lead sponsor: Sanford Health
Sponsor class: OTHER
First posted: 2024-07-29
Enrollment: 28
Sex: ALL
Minimum age (years): 14
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to explore patient outcomes associated with, the use of a 3D printed knee extender device, in conjunction with an at-home rehabilitation program, for patients who are performing knee rehabilitation after anterior cruciate ligament (ACL) surgery.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with a primary ACL rupture. Secondary knee pathology such as, but not limited to bone edema, strains, and meniscal pathology are acceptable as long as the primary injury and indication for surgery is the ACL rupture.
* Able and willing to adhere to the study procedures
* Able to consent for self-, or able to assent for self with parental consent

Exclusion Criteria:

* Pregnancy
* Non-English speaking

Primary outcomes:
measure: Knee Extension Range of Motion
timeFrame: Change from baseline range of motion to 6 week post-ACL surgery follow up visit.
measure: Time to Achieve Full Knee Extension
timeFrame: Through study completion, an average of 6 weeks.
Secondary outcomes:
measure: Knee Swelling
timeFrame: through study completion, an average of 6 weeks.
measure: Average Daily Pain Level
timeFrame: From baseline until their 6-week post-ACL surgery follow up visit, an average of 6 weeks.
measure: Water bottles used with knee extender device
timeFrame: From baseline until their 6-week post-ACL surgery follow up visit, an average of 6 weeks.
measure: Minutes Spent Using Knee Extender Device
timeFrame: From baseline until their 6-week post-ACL surgery follow up visit, an average of 6 weeks.
Other outcomes:
Locations:
city: Fargo
country: United States
facility: Sanford Orthopedics and Sports Medicine
state: North Dakota
city: Sioux Falls
country: United States
facility: Sanford Orthopedics and Sports Medicine
state: South Dakota
Study officials:
affiliation: Sanford Health
name: Nathan Skelley, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04306549: Twenty-Four-Month Clinical Comparison of Two Bulk-Fill and Microhybrid Composite Restorations
Official title: Twenty-Four-Month Clinical Comparison of Two Bulk-Fill and Microhybrid Composite Restorations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Restoration Failure of Marginal Integrity
Keywords: Clinical study
USPHS criteria
bulk-fill
resin composite
Class II
Lead sponsor: Tokat Gaziosmanpasa University
Sponsor class: OTHER
Collaborators: name: University of Beykent
name: Çanakkale Onsekiz Mart University
First posted: 2020-03-13
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 22
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: ABSTRACT Objective The aim of this study was to evaluate the clinical performance of one microhybrid and two bulk-fill resin composites in Class II cavities for up to two years.

Materials and methods In total, 75 Class II restorations were made in 25 patients, using three restorative materials: two nanohybrid bulk-fill resin composites, Sonic Fill (SF) and x-tra fil (XF), and a microhybrid composite, Filtek Z-250 (FZ). The restorations were blindly evaluated by two examiners at baseline and at 6, 12, and 24 months, using U.S. Public Health Service (USPHS) criteria. The restoration groups for each category were compared using the Pearson chi-square test, and the Cochran Q-test was used to compare the changes across different time points within each restorative material (p \<0.05).


Eligibility criteria: Inclusion Criteria:

* Patient in need of restoration of caries lesion (diagnosed with bitewing radiograph and clinical examination);
* teeth in need of restoration to be first or second molars or permanent premolars;
* at least three Class II restorations required in each patient and the number of restorations of each material to be equal in each patient;
* the antagonist and adjacent tooth in contact;
* pulp vitalized and free of painful symptoms; teeth involved not to have undergone direct pulp capping;
* no history of hypersensitivity in the teeth to be restored;
* permanent dentition;
* good oral health and absence of periodontal disease;
* patients not to have suffered from systemic diseases or allergies;
* absence of deleterious habits, xerostomia, and bruxism.

Exclusion Criteria:

* Fewer than 20 teeth;
* history of existing tooth sensitivity;
* known allergy to resin-based materials or any of the other materials used in this study;
* pregnancy or breastfeeding;
* chronic use of anti-inflammatory drugs, analgesic, and/or psychotropic drugs;
* non-vital teeth;
* abutment teeth for fixed or removable prostheses.

Primary outcomes:
measure: Clinical Acceptability
timeFrame: Twenty-Four-Month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05116449: Comparison of Changes in the Quality of Life of Patients Operated on Breast Cancer at the Drôme Ardèche Breast Institute According to Access to Supportive Oncological Care (IDSein)
Official title: Comparison of Changes in the Quality of Life of Patients Operated on Breast Cancer at the Drôme Ardèche Breast Institute According to Access to Supportive Oncological Care
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer Female
Lead sponsor: Ramsay Générale de Santé
Sponsor class: OTHER
Collaborators: name: European Clinical Trial Experts Network
First posted: 2021-11-11
Enrollment: 310
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women patient with breast cancer

Brief summary: The aim of this study is to explore the quality of life of cancer patients, in particular women operated on breast cancer, throughout their care journey, taking into account their access to supportive oncological care within and outside the establishment care.


Eligibility criteria: Inclusion Criteria:

* Woman with histologically confirmed invasive breast cancer for whom surgery is scheduled
* Age\> 18 years old
* Performance status ECOG \<2
* Patient speaking and understanding French and able to complete questionnaires
* Patient affiliated or beneficiary of a social security scheme
* Patient having read the information note and not objecting to the use of the data collected

Exclusion Criteria:

* male
* Patient treated with neoadjuvant chemotherapy
* Patient participating in a therapeutic trial
* Patient with metastatic breast cancer
* Patient with bilateral breast cancer
* History of cancer of less than 5 years
* Active infection or other serious underlying condition that may prevent the patient from receiving treatment
* History or progressive psychiatric illness
* Person deprived of liberty or under guardianship
* Inability to undergo medical monitoring for geographical, social or psychological reasons Indication of emergency amputation
* Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
* Pregnant, breastfeeding or parturient woman
* Patient hospitalized without consent

Primary outcomes:
measure: Quality of life questionnaire : FACT-B
timeFrame: 12 months
measure: Quality of life questionnaire : EORTC QLQ-C30
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Guilherand-Granges
country: France
facility: Institut du sein Drôme Ardèche
Study officials:
References:
Clinical trial NCT06365749: Genetic Feature of Congenital Hearing Loss in Chinese Population
Official title: Exome Sequencing Explored the Genetic Characteristics Congenital Hearing Loss in Chinese Population
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Congenital Hearing Loss
Congenital Deafness
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2024-04-15
Enrollment: 50
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Neonates who were offered neonatal hearing screening programs at Tongji hospital.

Brief summary: Congenital hearing loss, as well as hearing loss present at birth, is one of the most common chronic conditions in children, with a prevalence of permanent bilateral hearing loss of 2.83 per 1000 children of primary school age, which is mainly caused by genetic factors. The goal of this observational study is to learn about novel causative genes in infants with hearing loss in the Chinese population. The main problem it aims to deal with are:

* to present the genetic characteristics of the infant with hearing loss in the Chinese population
* to build up a prognostic model base on diverse data.

Participants will be asked to receive audiological tests and collection of the peripheral blood sample.


Eligibility criteria: Inclusion Criteria:

* Age up to 6 months
* Fail in the neonatal hearing screening programs, including oto-acoustic emissions and automated auditory brain stem response
* Promise to complete the tests required at baseline and follow-ups by the legal representative
* Informed consent by the legal representative

Exclusion Criteria:

* Congenital infections related to acquired or congenital hearing loss, including rubella virus, cytomegalovirus, herpes simplex virus, rubella virus, toxoplasma gondii and treponema pallidum infections
* Other explicit otologic conditions which could induce hearing loss, including cerumen, otitis media, congenital middle ear abnormalities, microtia and external ear abnormalities
* A drug with ototoxicity usage during pregnancy
* Other severe congenital anomalies

Primary outcomes:
measure: Whole exome sequencing data
timeFrame: Baseline
Secondary outcomes:
measure: TEOAE-based otoacoustic emissions test outcome measure
timeFrame: Baseline
measure: Auditory brainstem response testing
timeFrame: Baseline
measure: Acoustic impedance
timeFrame: Baseline
measure: Audiogram
timeFrame: 4 years follow up
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02390349: "CuraMed" and "Curamin" in Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Lead sponsor: EuroPharma, Inc.
Sponsor class: INDUSTRY
First posted: 2015-03-17
Enrollment: 179
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized, placebo-controlled study evaluates the effects of CuraMed ® (BCM-95 ®) and Curamin ® in the treatment of osteoarthritis. One group will receive CuraMed, one group will receive Curamin and one group will receive placebo.


Eligibility criteria: Inclusion Criteria:

* Patients with a diagnosis of degenerative hypertrophic osteoarthritis of the knee (M17, according to International Classification of Diseases (ICD-10) of bone joints, verified by radiography (Grade 1-3 by Kellgren-Lawrence radiographic grades).

Exclusion Criteria:

* subjects with inflammatory and any secondary arthritis
* moderate and severe synovitis (grades 2 and 3)
* tear of meniscus
* chronic diseases of the kidneys, liver, gastrointestinal, cardiovascular, endocrine and nervous systems
* allergic anamnesis and drug intolerance
* pregnant or nursing
* history of substance abuse
* subjects taking non-steroidal anti-inflammatory drugs and analgesics within 2 weeks prior to the study
* subjects taking glucosamine sulfate, chondroitin sulfate, intra-articular hyaluronate, systemic or intra-articular glucocorticoids within three months prior to the study

Primary outcomes:
measure: Effect of Curamin and Curamed on joint pain as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: 12 weeks
measure: Effects of Curamin and Curamed on physical performance measures using the Osteoarthritis Research Society International (OARSI) tests of physical function
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Yerevan
country: Armenia
facility: Erebuni Medical Center
Study officials:
References:
citation: Haroyan A, Mukuchyan V, Mkrtchyan N, Minasyan N, Gasparyan S, Sargsyan A, Narimanyan M, Hovhannisyan A. Efficacy and safety of curcumin and its combination with boswellic acid in osteoarthritis: a comparative, randomized, double-blind, placebo-controlled study. BMC Complement Altern Med. 2018 Jan 9;18(1):7. doi: 10.1186/s12906-017-2062-z.
Clinical trial NCT05021549: Apneic Oxygenation for Morbid Obese Parturient in cs
Official title: Effectiveness of Apneic Oxygenation for Morbid Obese Parturient Performing Elective Caesarean Section Under General Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Morbid Obesity
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2021-08-25
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1. Morbid obesity parturient defined as a body mass index (BMI) above 40 kg/m2.
2. ASA physical status I-II
3. Age above 18 years.
4. Scheduled for elective caesarean section under general anesthesia.
Primary purpose: PREVENTION

Brief summary: The aim of this study is to compare the effect of apneic preoxygenation to conventional preoxygenation on the oxygen desaturation in morbid obese parturient performing elective caesarean section under general anesthesia.

Detailed description: Anesthetic management of the obese parturient is challenging. Both pregnancy and obesity are risk factors for a difficult airway and anesthesia-related maternal mortality. There is increased risk of difficult intubation associated with an increased difficultly in mask ventilation and increased risk of accelerated desaturation during apnea.

The use of apneic oxygenation for the optimization of peri-intubation conditions is a promising means of preventing hypoxemia.

Despite the recommendation of the use of nasal prongs to insufflate oxygen at flows of 5 L/min to 15 L/min during the apneic period randomized controlled trial is still not available in the morbidly obese parturient.

Eligibility criteria: Inclusion Criteria:

1. Morbid obesity parturient defined as a body mass index (BMI) above 40 kg/m2.
2. ASA physical status I-II
3. Age above 18 years.
4. Scheduled for elective caesarean section under general anesthesia.

Exclusion Criteria:

1. Parturient of ASA physical status III or above.
2. Suspected or known difficult airway (Mallampati class \> 2, reduced neck movement, reduced mouth opening, or Cormack-Lehane grade 4 recorded during a previous intubation procedure).
3. Any contraindication for nasal prong use, for example, tumours, fractures or trauma.
4. SpO2 ≤ 97% prior to preoxygenation.

Primary outcomes:
measure: the lowest oxygen saturation recorded
timeFrame: during intubation procedure
Secondary outcomes:
measure: rates of desaturation below SpO2 90%
timeFrame: during intubation procedure
measure: rates of critical desaturation below SpO2 80%
timeFrame: during intubation procedure
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams university
city: Cairo
country: Egypt
facility: Faculty of medicine
Study officials:
References:
Clinical trial NCT06062849: Is it Really Necessary to Insert a Nephrostomy Tube or Double J Stent in Percutaneous Nephrolithotomy?
Official title: Is it Really Necessary to Insert a Nephrostomy Tube or Double J Stent in Percutaneous Nephrolithotomy?
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Kidney Calculi
Postoperative Pain
Keywords: percutaneous nephrolithotomy
nephrostomy tube
double J stent
Lead sponsor: Bursa City Hospital
Sponsor class: OTHER_GOV
First posted: 2023-10-02
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study, investigators aimed to compare the postoperative pain status and comfort situations depending on instruments used in the percutaneous nephrolithotomy operation

Detailed description: A total of 90 patients aged 18 and over will undergo percutaneous nephrolithotomy (PNL) for kidney stones of 2 cm or more between 01/08/2023 and 01/02/2024 will be included in the study. Preoperative demographic data of the patients, body mass index (BMI), stone size and stone location, hemogram, biochemistry, coagulation parameters, urine analysis, and urine culture test results will be recorded. Radiological evaluation will be obtained according to computerized tomography (CT) data. While patients aged 18 years and above with kidney stones larger than 2 cm were included in the study, patients under 18 years of age, patients with anatomical anomalies (horseshoe kidney, ectopic kidney, ureteropelvic junction stenosis, ureteral stenosis), patients with uncorrectable bleeding diathesis, bilateral kidney stones will not be included in the study.

Patients who do not have major complications (serious bleeding, renal pelvis perforation) after the PNL procedure and residual stones cannot be detected according to the scopic image obtained will be randomized and divided into three groups. Patients in the first group will not be fitted with a Double J (JJ) stent and/or nephrostomy (Completely Tubeless), patients in the second group will only be fitted with a JJ stent, and patients in the third group will only be fitted with a 14 French Malecot nephrostomy. The patients' pain scores, analgesic use, hemoglobin values, operation success, complications, and additional procedure requirements in the postoperative period will be compared.

Eligibility criteria: Inclusion Criteria:

* Patients aged 18 years and above
* Larger than 2 cm kidney stones

Exclusion Criteria:

* Under 18 years of age
* Anatomical anomalies (horseshoe kidney, ectopic kidney, ureteropelvic junction stenosis, ureteral stenosis),
* Uncorrectable bleeding diathesis
* Bilateral kidney stones

Primary outcomes:
measure: postoperative pain
timeFrame: 6 months
measure: postoperative urine leakage
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bursa
country: Turkey
facility: Bursa City Hospital
Study officials:
affiliation: Bursa City Hospital
name: Sedat Oner, MD
role: STUDY_DIRECTOR
References: