louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04523636: Evaluation of Splinting in Tetraplegia
Official title: Evaluation of Splinting in Tetraplegia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injury Cervical
Splints
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
Collaborators: name: University of Maryland, Baltimore
name: The Craig H. Neilsen Foundation
First posted: 2020-08-21
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Each extremity was randomized to receive a custom or pre-fabricated resting hand splint.
Primary purpose: TREATMENT

Brief summary: This study compared pre-fabricated and custom resting hand splints among people who were in inpatient rehabilitation after a cervical spinal cord injury.

Detailed description: This was randomized parallel group controlled clinical trial where arms, not patients were the unit of randomization. This trial was funded by the Craig H. Neilsen Allied Health Professional Development Award of the American Spinal Injury Association (ASIA). This research was conducted at a 32-bed spinal cord injury and multi-trauma rehabilitation unit in an urban center. Participants were recruited from an inpatient spinal cord injury rehabilitation unit. Eligible participants were 18 years or older and undergoing acute rehabilitation after a cervical spinal cord injury with hand function impairment, and the primary occupational therapist deemed splinting intervention was required. Each eligible extremity was randomized to receive a custom or pre-fabricated resting hand splint for night use.

Eligibility criteria: Inclusion Criteria:

* Spinal Cord Injury
* Inpatient Rehabilitation
* Limited hand function

Exclusion Criteria:

* Under 18
* Full hand function
* Orthopedic injury to hand

Primary outcomes:
measure: Change in scores on The Graded Redefined Assessment of Strength, Sensation and Prehension (GRASSP).
timeFrame: This assessment is completed within 5 days of initating the splinting intervention and within 3 days of discharge. Length of time between data collection was limited to 12 weeks.
Secondary outcomes:
measure: Splint Perception Survey
timeFrame: This assessment was completed within 3 days of discharge and no more than 12 weeks after the intervention was initiated.
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of MD Rehabilitation & Orthopaedic Institute
state: Maryland
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
Study officials:
affiliation: University of Maryland, Baltimore
name: Peter Gorman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Maryland, Baltimore
name: Paula Geigle, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Thomas Jefferson University
name: Sara Frye, MS
role: STUDY_DIRECTOR
References:
Clinical trial NCT00691236: Evaluation of Zoledronic Acid as a Single Agent or as an Adjuvant to Chemotherapy in High Grade Osteosarcoma
Official title: Evaluation of Zoledronic Acid as a Single Agent and as an Adjuvant to Chemotherapy in the Management of High Grade Osteosarcoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Osteosarcoma
Keywords: osteosarcoma
zoledronic acid
bisphosphonates
adjuvant to chemotherapy
Lead sponsor: Tata Memorial Hospital
Sponsor class: OTHER_GOV
First posted: 2008-06-05
Enrollment: 60
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: TREATMENT

Brief summary: This trial will be a pilot study to find out if zoledronic acid improves the response to chemotherapy in high grade osteosarcoma. In arm A of the study, 40 adult patients will be randomised into two groups. One group will get standard chemotherapy and the other group will get Zoledronic acid in addition to chemotherapy. The investigators will assess the histological necrosis as well as disease status for up to 2 years.

In Arm B, adult patients with relapsed disease or advanced disease who are unable to take any other therapy and are given only symptomatic care will be given 6 doses of zoledronic acid and followed up for disease status. This will be to determine the role of zoledronic acid as a single agent.


Eligibility criteria: Inclusion Criteria:

1. Adult patients (between the ages of 18 to 65 years) with a recently diagnosed high grade osteosarcoma of the extremity
2. Non Metastatic at presentation. The metastases are ruled out by a CT scan of the chest and a PET scan.
3. Patients are willing and able to afford the standard chemotherapy.

Exclusion Criteria:

1. Non-extremity sarcomas. (pelvis and spine)
2. Age less than 18 years or greater than 65 years
3. Metastatic at presentation
4. Pregnant or lactating women
5. Renal dysfunction in the form of elevated serum creatinine
6. Dental treatment anticipated after evaluation.
7. Patients who have received or are likely to receive steroids.

Primary outcomes:
measure: histological response disease free interval
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Mumbai
country: India
facility: Tata Memorial Hospital
state: Maharashtra
Study officials:
affiliation: Tata Memorial Hospital
name: Manish Agarwal, M.S(Orth)
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01931436: Pharmacokinetics Study of Qing'E Pill
Official title: A Single-site, Single-dose and Multiple-dose Study to Evaluate the Pharmacokinetics of the Main Components of Qing'E Pill (a Chinese Medicine Formula) Into the Blood in Chinese Menopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Menopause
Keywords: Menopause, pharmacokinetic
Lead sponsor: Shanghai University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Wuxi People's Hospital
First posted: 2013-08-29
Enrollment: 24
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study will investigate the pharmacokinetics of single and multiple doses of Qing'E pills in Chinese menopause volunteers. The main components of Qing'E pill into the blood such as psoralen and Isopsoralen will be detected.


Eligibility criteria: Inclusion Criteria:

1. Women age between 40 to 60 Years, Suffering from irregular menstrual cycle or amenorrhea of 3-11 months.
2. Moderate to severe hot flashes (associated with sweating)≥5 times /24 hours.
3. The score of Kupperman index is not less than 15.
4. Patients unused estrogen tablets or progesterone injection in 6 months.
5. Patients must discontinue other therapies in the treatment of menopausal syndrome for more than 3 months.
6. Get subjects informed consent process should comply with GCP requirements.

Exclusion Criteria:

1. There is no clinical significance abnormal in physical and laboratory examination.
2. Bilateral oophorectomy, endometrial lesions, uterine polyps, abnormal vaginal bleeding, severe breast hyperplasia, with family history of breast cancer.
3. Patients with hypertension, primary hypotension and chronic anemia (Hb ≤ 90 g/L).
4. Patients with hyperthyroidism, coronary atheroma, diabetes, obesity (body mass index of more than 30 kg/m2), migraine, malignant tumors, thromboembolic disease, gastrointestinal diseases affect absorption or autoimmune diseases.
5. Patients with diseases of the cardiovascular, cerebrovascular, liver, kidney and hematopoietic system, or mentally ill.
6. People with allergies.
7. People taking other drugs within 14 days before the trail.
8. Patients are participating in other clinical trials within 3 months.
9. Pregnant Women.
10. Alcoholics or smokers (past or smoking).

Primary outcomes:
measure: Pharmacokinetic parameters of the main components of Qing'E pill (Maximum plasma concentration (Cmax), Area under the plasma concentration curve (AUClast and AUC))
timeFrame: Up to 48 hours postdose for each period
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai University of Traditional Chinese Medicine
state: Shanghai
Study officials:
References:
Clinical trial NCT05680636: New Clinical Score for Deep Vein Thrombosis
Official title: A New Clinical Score for Deep Vein Thrombosis: the Role of Differential Leg Skin Temperature Measured With Handheld Low-cost Infrared Thermometers.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Deep Vein Thrombosis
Lead sponsor: Accademia Italiana Medicina Osteopatica
Sponsor class: OTHER
First posted: 2023-01-11
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Suspicion of deep vein thrombosis should be based on the presence of at least one of the following signs/symptoms

* unilateral swelling of the lower limbs
* unilateral erythema of the lower limbs
* unilateral pain in the lower limbs

Brief summary: A new Clinical Score (CS) to rule out Deep Vein Thrombosis (DVT) has to be derived and internally validated (with bootstrap method), from patients suspected of DVT in Italy. Primary care physicians (general practitioners) in Lombardy will be instructed to inform patients suspected of DVT about this research and get in touch with the team to get details and, eventually, volunteer for the study. The CS includes categorical variables and a continuous variable: the differential leg skin temperature measured with a low-cost handheld infrared thermometer in object surface mode.


Eligibility criteria: Inclusion Criteria:

* Patients suspected of deep vein thrombosis.

Exclusion Criteria:

* under 18 years of age

Primary outcomes:
measure: presence of DVT
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Gessate
country: Italy
facility: Studio Medico
state: Milano
Study officials:
affiliation: Accademia Italiana Medicina Osteopatica
name: Laurent Mapelli, Bsc (HOns)
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04021836: Three Dimensional Evaluation of Nasolabial Changes Following Classic vs Without Alar Base Suture After Le Fort I Osteotomy
Official title: Three Dimensional Evaluation of Nasolabial Changes Following Classic vs Without Alar Base Suture After Le Fort I Osteotomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Quality of Life
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-07-16
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Three dimensional evaluation of nasolabial changes following classic vs without alar base suture after Le Fort I osteotomy
Primary purpose: OTHER

Brief summary: Three dimensional evaluation of nasolabial changes following classic vs without alar base suture after

Le Fort I osteotomy

A randomized controlled clinical trial


Eligibility criteria: Inclusion Criteria:

1. Adult patients with skeletal maxillomandibular deformity indicated for surgical correction by Le Fort I osteotomy.
2. Absence of growth.
3. Patients must be willing for the surgical procedure and follow-up, with his informed consent.

Exclusion Criteria:

* 4. History of facial trauma with fractures of facial bones. 5. History of surgical operation in nasal region. 6. Facial asymmetry. 7. Patients with accompanying craniofacial syndromes. 8. Patients with any diseases that compromise bone or soft tissue healing. 9. Anterior open bite cases. 10. Clefts ( lip and palate). 11. Medically compromised patients not fit for general anaesthesia. 12. missing preoperative or postop-erative 3D photographs or CBCT scans 13. multi-segment Le Fort I osteotomy 14. rhinoplasty surgery during or within 1 year after the Le Fort I osteotomy

Primary outcomes:
measure: Widening of alar base
timeFrame: 6 months
Secondary outcomes:
measure: Nasal volume
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02671136: Hyperbaric Oxygen Therapy as Adjunctive Therapy to Scaling and Root-planing in the Management of Periodontitis in Patients With Type 2 Diabetes
Official title: Hyperbaric Oxygen Therapy as Adjunctive Therapy to Scaling and Root-planing in the Management of Periodontitis in Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Diabetes
Periodontitis
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2016-02-02
Enrollment: 3
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Diabetes and Periodontitis are both prevalent diseases affecting millions of Americans. Periodontitis is prevalent among Diabetics. Furthermore, Periodontitis and associated inflammation can increase insulin resistance in Diabetics and worsens the condition. Hyperbaric Oxygen Therapy (HBOT) has the potential to improve periodontal treatment outcome in poorly controlled diabetics. The study will compare periodontal treatment (SRP) outcome between 2 main diabetic type 2 patient groups receiving medical care treatment: either Conventional Wound Therapies (CWC) with or without adjunctive Hyperbaric Oxygen Therapy at LLU Health.

24 poorly controlled diabetic mellitus (DM) type 2 subjects (HbA1c =\>7%) with Periodontitis will be assigned into the study arms HBO therapy and Non HBO therapy, based on their medical needs.

For all subjects demographic data (age, gender, ethnicity, smoking history, alcohol use history, BMI, current medication list) and oral health habits will be obtained. Blood samples for HbA1c determinations, clinical periodontal measurements (plaque index, probing measurements including pocket depth, attachment levels, gingival index and bleeding-on-probing) and subgingival microbial samples will be obtained at baseline and end of the study. Subgingival microbial samples will be collected from three randomly selected sites and analyzed for detection of about 300 of the most prevalent oral bacterial species. Differences in periodontal clinical outcomes and bacterial profiles will be identified utilizing ANCOVA (Analysis of Covariance).


Eligibility criteria: Inclusion Criteria:

* Diabetes type 2 (HbA1c =\>7%)
* Generalized moderate to severe chronic periodontitis.
* Minimum of 10 permanent teeth
* Registered LLU patients

Exclusion Criteria:

* Well controlled Diabetes type 2
* Other systematic conditions with known associations to periodontitis
* Intra-oral conditions which may interfere with the accuracy of periodontal probing
* BMI greater than 45%

Primary outcomes:
measure: Counts of Each Subgingival Bacterial Species
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University
state: California
Study officials:
affiliation: Faculty
name: Ahmed Khocht, DDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06179836: Chinese Severe Brain Injury Trial
Official title: Chinese Severe Brain Injury Trial
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Severe Brain Injury
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
First posted: 2023-12-22
Enrollment: 3000
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: Patients with impaired consciousness with a clear cause of brain injury.

Brief summary: Building a Large Chinese Cohort(Chinese Severe brain injury Trial）


Eligibility criteria: Inclusion Criteria:

* a clear cause of brain injury
* disorders of consciousness, GCS≤12
* within six months of onset

Exclusion Criteria:

* not applicable

Primary outcomes:
measure: Glasgow Outcome Scale
timeFrame: 6 months after severe Brain Injury
Secondary outcomes:
measure: Glasgow Outcome Scale
timeFrame: 3 months and 12 months after severe Brain Injury
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04783636: To Compare the Safety and Pharmacokinetics of PT105 With PT105R in Healthy Postmenopausal Female Volunteers
Official title: A Randomized, Open-label, Single-dosing, 2x2 Crossover Phase 1 Study to Compare the Safety and Pharmacokinetics of PT105 With PT105R in Healthy Postmenopausal Female Volunteers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Prostate Cancer
Lead sponsor: Peptron, Inc.
Sponsor class: INDUSTRY
First posted: 2021-03-05
Enrollment: 40
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of study is to compare the safety and pharmacokinetics of PT105 with PT105R in healthy postmenopausal female volunteers

Detailed description: The purpose of study is to confirm the safety and pharmacokinetics of PT105 in healthy postmenopausal female volunteers

Eligibility criteria: Inclusion Criteria:

* A healthy woman who is over 19 years of age and has been certified obstetrically with menopause, at the time of screening.
* Subjects weighing over 50 kg with BMI between 18 and 30 kg/m2 (inclusive) at screening visit.

Exclusion Criteria:

* Those who have clinical significant liver, kidney, nervous system, respiratory, endocrine, hematology and oncology, cardiovascular, urinary, and mental diseases or past history
* Those whose plasma AST and ALT exceed 2 times to the upper limit of the normal range in screening including additional examinations prior to randomization
* Subjects who have participated and taken investigational drug in any other clinical trial (including bioequivalence study) within six months prior to study drug administration
* Subjects who have donated a unit of whole blood within two months or blood components within one month prior to study drug administration

Primary outcomes:
measure: AUC7-t of Leuprolide
timeFrame: 0h, 0.5, 1, 2, 4, 8, 12, 24, 72, 168, 240, 336, 504, 672, 840, 1008 hr
measure: AUCt of Leuprolide
timeFrame: 0h, 0.5, 1, 2, 4, 8, 12, 24, 72, 168, 240, 336, 504, 672, 840, 1008 hr
measure: AUCinf of Leuprolide
timeFrame: 0h, 0.5, 1, 2, 4, 8, 12, 24, 72, 168, 240, 336, 504, 672, 840, 1008 hr
measure: Cmax of Leuprolide
timeFrame: 0h, 0.5, 1, 2, 4, 8, 12, 24, 72, 168, 240, 336, 504, 672, 840, 1008 hr
Secondary outcomes:
measure: Tmax of Leuprolide
timeFrame: 0h, 0.5, 1, 2, 4, 8, 12, 24, 72, 168, 240, 336, 504, 672, 840, 1008 hr
measure: t1/2 of Leuprolide
timeFrame: 0h, 0.5, 1, 2, 4, 8, 12, 24, 72, 168, 240, 336, 504, 672, 840, 1008 hr
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00996541: Support To Reunite Involve and Value Each Other
Official title: Diverting Homeless Youth From Chronic Homelessness and Risk for HIV
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Family Relations
Runaway Behavior
Risky Sexual Behavior
Substance Use
Keywords: Runaway youth
Homeless youth
Family intervention
Family functioning
HIV risk behavior
HIV Seronegativity
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2009-10-16
Enrollment: 302
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Runaway and homeless youth are at risk for HIV based upon their rates of substance use, particularly injection drug use, unprotected sexual intercourse, multiple partners, and sexually transmitted diseases. Risk increases as the time away from home increases. STRIVE is a family intervention aimed at increasing residential stability, decreasing runaway episodes, and decreasing HIV risk. Families are randomly assigned to a cognitive-behavioral skills-building intervention consisting of five weekly sessions delivered at family homes, or are assigned to standard care. Sessions are aimed at increasing problem solving, role clarity, and positive interactions. It is hypothesized that the intervention will result in improved family dynamics, less runaway behavior, and less risky behavior.


Eligibility criteria: Inclusion Criteria:

* Youth: Age 12-17 who ran away or were told to leave home within the past 6 months. Must provide assent and parent/guardian must provide informed consent.
* Parent/guardian: must be parent/guardian of participating youth who ran away. Must provide informed consent.

Exclusion Criteria:

* Youth: total time away from home exceeds 12 months. Obvious cognitive impairment. Sexual or physical abuse from the parent/guardian. Lack of assent/consent.
* Parent/guardian: obvious cognitive impairment. Lack of consent.

Primary outcomes:
measure: Improved residential stability
timeFrame: Assessed up to 24 months
Secondary outcomes:
measure: Reduced HIV risk behavior
timeFrame: Up to 24 months
Other outcomes:
Locations:
Study officials:
References:
citation: Milburn NG, Iribarren FJ, Rice E, Lightfoot M, Solorio R, Rotheram-Borus MJ, Desmond K, Lee A, Alexander K, Maresca K, Eastmen K, Arnold EM, Duan N. A family intervention to reduce sexual risk behavior, substance use, and delinquency among newly homeless youth. J Adolesc Health. 2012 Apr;50(4):358-64. doi: 10.1016/j.jadohealth.2011.08.009. Epub 2011 Oct 26.