louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06972719: Hormone Replacement Therapy After Risk Reducing Salpingo-oophorectomy
Official title: Patient Centered Education About Hormone Replacement Therapy After Risk Reducing Salpingo-oophorectomy: a Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: BRCA1 Mutation
BRCA2 Mutation
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2025-05-15
Enrollment: 50
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this study is to develop an educational aid about hormone replacement therapy that physicians can share with patients as part of their pre-surgical counseling for a risk-reducing salpingo-oophorectomy (RRSO).

Detailed description: The proposed randomized study seeks to enroll 50 individuals from gynecologic oncology and high-risk breast clinics who are actively planning RRSO. Participants will be randomized to usual provider education versus usual education plus video education. The researchers will assess participants' level of conflict around the decision to use HRT, their satisfaction with their decision, their satisfaction with their counseling, and their postoperative decision regarding HRT. This project will provide pilot data for a larger randomized trial. Ultimately, the investigators seek to create a comprehensive aid for education and values clarification, with the aim of improving informed decision making for individuals with BRCA1-2 mutations.

Eligibility criteria: Inclusion Criteria:

* BRCA1 or BRCA2 germline mutation
* scheduled for a risk-reducing salpingo-oophorectomy (RRSO) by Duke Gynecologic Oncologist
* premenopausal

Exclusion Criteria:

* personal history of cancer
* postmenopausal
* \>50 years old
* unable to provide informed consent in English

Primary outcomes:
measure: Decisional Conflict pre-randomization
timeFrame: Baseline, pre-randomization
measure: Decisional Conflict post-intervention
timeFrame: Immediately after the intervention
measure: Decisional Conflict post-operatively
timeFrame: 2-6 weeks post op
measure: Satisfaction with Counseling
timeFrame: 2-6 weeks post op
measure: Satisfaction with Decision
timeFrame: 3-6 months post op
Secondary outcomes:
measure: Number of participants who decide to take HRT
timeFrame: 3-6 months post op
measure: Number of participants who decide to take estrogen, a progesterone, or an estrogen + progesterone medication
timeFrame: 3-6 months post op
Other outcomes:
Locations:
Study officials:
affiliation: Duke University
name: Laura Havrilesky
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02938819: Goal-oriented Intervention in Parkinson's Disease
Official title: Effects of a Goal-oriented Upper-limb Intervention in Patients With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson's Disease
Keywords: upper limbs
physiotherapy
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2016-10-19
Enrollment: 54
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Upper-limb disorders in patients with Parkinson's disease include decreased speed and amplitude of movements, difficulty in sequential tasks, and disrupted execution of fine manipulative hand activities.The aim of the study was to evaluate the effects of home-based goal-oriented upper limb intervention in patients with Parkinson's disease.

Detailed description: Parkinson's disease is a neurodegenerative neurological disorders involving progressive impairment in motor, mood and cognitive functions. Movement disorders have a negative impact on individual's ability to perform well-learned motor skills. These include akinesia, bradykinesia, rigidity and tremor at rest.

A goal-planning process should be useful to ensure that patients agree on the goals of rehabilitation. Thus, the purpose of the study was to evaluate the effects of home-based goal-oriented upper limb intervention in patients with Parkinson's disease.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Parkinson's Disease.
* Stage II-III of disease progression as defined by the Hoehn and Yahr scale.
* Upper limbs impairment

Exclusion Criteria:

* Clinical signs of dementia or psychiatric disturbance.
* Comprehension deficits that prevented them from following verbal commands.
* Visual or acoustic limitations.
* A neurologic condition other than Parkinson's Disease.
* Musculoskeletal disorders and/or if they had previous trauma or fracture of upper extremity.

Primary outcomes:
measure: Goals attainment
timeFrame: Change from baseline goals attainment assessment at 4 weeks.
Secondary outcomes:
measure: Manual dexterity
timeFrame: Change from baseline manual dexterity at 4 weeks
measure: Handgrip strength
timeFrame: Change from baseline handgrip strength at 4 weeks
measure: Finger prehension force
timeFrame: Change from baseline finger prehension force at 4 weeks
Other outcomes:
Locations:
city: Granada
country: Spain
facility: Department of Physical Therapy
Study officials:
affiliation: Universidad de Granada
name: Marie Carmen Valenza, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04398719: CBD-Microglia PET Study
Official title: Effect of Cannabidiol on Microglial Activation and Central Pain-Sensitization
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: CBD
Healthy
Keywords: Control
PET Scan
MRI Scan
Central Pain-Sensitization
Cannabidiol
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2020-05-21
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study aims to examine the effect of cannabidiol (CBD) pre-treatment on brain microglial activation in healthy human subjects. Secondarily, this study aims to examine the effect of cannabidiol (CBD) pre-treatment on central pain-sensitization in healthy human subjects.

Detailed description: This study aims to examine the effect of cannabidiol (CBD), pre-treatment, as Epidiolex, on brain microglial activation in healthy human subjects using \[11C\]PBR28 PET imaging. Secondarily, this study aims to examine the effect of cannabidiol (CBD) pre-treatment on central pain-sensitization in healthy human subjects. Lastly, this research study will also examine the relationship between brain microglial activation and central pain sensitization with CBD pre-treatment.

Eligibility criteria: Inclusion Criteria:

1. Men and women aged 18- 55 years
2. No significant medical or neurological illness
3. No implanted metal devices that may pose a risk during MRI scanning
4. Within the annual permissible radiation exposure
5. Able to provide written informed consent.

Exclusion Criteria:

1. Current use of any medications
2. Presence of metal in the body
3. Pregnancy or lactation

Primary outcomes:
measure: Microglial activation using [11C]PBR28 PET imaging
timeFrame: 10 Days
Secondary outcomes:
measure: Capsaicin-induced hyperalgesia
timeFrame: 10 Days
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Connecticut Mental Health Center
state: Connecticut
Study officials:
affiliation: Yale University
name: Rajiv Radhakrishnan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00584519: Control of Metabolic and Cardiovascular Risk in Patients With Schizophrenia and Overweight
Official title: Control of Metabolic and Cardiovascular Risk in Patients With Schizophrenia and Overweight (CRESSOB)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia
Keywords: Schizophrenia, Overweight, Cardiovascular Risk, Obesity
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-01-02
Enrollment: 430
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Community sample. Patients \>17 years older with diagnosis of Schizophrenia (DSM-IV TR) and Overweight (BMI more or equal to 25 Kg/m2)

Brief summary: To analyse the progress of modifiable metabolic risk factors (Blood pressure, cigarette smoking, waist perimeter, BMI, glycemia and lipidic profile) in schizophrenic patients with overweight for 12 months.

To analyse the perceived health status and the level of functioning and disability of patients with schizophrenia and overweight and their progress at 3, 6 and 12 months.

To assess the progress of the symptoms of the disease at 6 and 12 months.

Detailed description: Consecutive patient sampling. Any investigational site four consecutive patients with diagnosis of Schizophrenia (DSM-IV TR) and Overweight (BMI more or equal to 25 Kg/m2)

Eligibility criteria: Inclusion Criteria:

* Patients with diagnosis of schizophrenia, schizophreniform or schizoaffective disorder (DSM-IV TR)
* Patients with BMI (body mass index) more or equal to 25 Kg/m2
* Patients or their legal representative have provided written informed consent

Exclusion Criteria:

* Patients are unable to complete or to understand health questionnaires in Spanish language
* Patients are currently enrolled on clinical trials or other investigational studies

Primary outcomes:
measure: Evolution of modifiable metabolic risk factors (Blood pressure, cigarette smoking, waist perimeter, BMI, glycemia and lipidic profile) in schizophrenic patients with overweight for 12 months.
timeFrame: 12 months
Secondary outcomes:
measure: Cardiovascular Risk
timeFrame: 12 months
measure: To assess the progress of the symptoms and clinical evolution of the disease
timeFrame: 12 months
measure: Patient Functional Impairment
timeFrame: 12 months
measure: Patient Quality of Life
timeFrame: 12 months
measure: Current Pattern of Treatment in this Population
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT03716141: Autologous Platelets Rich Plasma (APRP) Treatment Vs Saline Dressing for the Management of Diabetic Foot Ulcer
Official title: Autologous Platelets Rich Plasma (APRP) Treatment Vs Saline Dressing for the Management of Diabetic Foot Ulcer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Foot Ulcer
Lead sponsor: Services Hospital, Lahore
Sponsor class: OTHER_GOV
First posted: 2018-10-23
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare between the platelet rich plasma and normal saline dressing in the healing diabetic foot ulcers. It will be a randomized controlled trial.


Eligibility criteria: Inclusion Criteria:

* Diabetic foot wound less than 5cm in greatest diameter Non healing duration greater than 3 months Non infected Palpable distal pulses

Exclusion Criteria:

* Infected wound Wound greater than 5 cm Patient having HBa1c greater than 8% Renal failure Wound with bone exposed or having osteomyelitis

Primary outcomes:
measure: Wound Healing
timeFrame: 8 to 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Services hospital
state: Punjab
Study officials:
affiliation: Services Hospital, Lahore
name: Mahmmood Ayyaz, mbbs, fcps
role: STUDY_DIRECTOR
References:
Clinical trial NCT01844141: Effectiveness of Lavage With Alcohol - Chlorhexidine for Chemical Matricectomy
Official title: Effectiveness of the Lavage With 70% Alcohol Plus 0.5% Chlorhexidine Compared to 70% Alcohol for Chemical Matricectomy in the Surgical Treatment of Ingrown Toenails
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Ingrown Toenail
Keywords: phenol
ingrown toenail
chemical matricectomy
Lead sponsor: Universidad Complutense de Madrid
Sponsor class: OTHER
First posted: 2013-05-01
Enrollment: 40
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: To compare the efficacy of the lavage with 70% alcohol plus 0.5% chlorhexidine versus 70% alcohol in the surgical treatment of ingrown toenails.

Detailed description: The purpose of this study is to compare the efficacy of the lavage with 70% alcohol plus 0.5% chlorhexidine versus 70% alcohol during the phenolization procedure in the surgical treatment of ingrown toenails in patients undergoing for chemical matricectomy.

Eligibility criteria: Inclusion Criteria:

* Older than 18 with onychocryptosis

Exclusion Criteria:

* infection, history of tinea pedis, onychomycosis, paronychia, nail trauma or subungual hematoma, nail deformities and disorders, peripheral vascular disease or diabetes, cardiac disease, history of rheumatic fever, recent antibiotic use or current antimicrobial therapy, history of steroid use and recent nail polish use

Primary outcomes:
measure: Quantity of phenol recovered in each lavage with each solution
timeFrame: up to 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Universidad Complutense de Madrid (Podología)
Study officials:
affiliation: Universidad Complutense de Madrid
name: Ricardo Becerro de Bengoa, Phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: Plusje LG. Pincer nails: a new surgical treatment. Dermatol Surg. 2001 Jan;27(1):41-3.
citation: Baran R, Haneke E, Richert B. Pincer nails: definition and surgical treatment. Dermatol Surg. 2001 Mar;27(3):261-6.
citation: Gao W, Legido-Quigley C. Fast and sensitive high performance liquid chromatography analysis of cosmetic creams for hydroquinone, phenol and six preservatives. J Chromatogr A. 2011 Jul 15;1218(28):4307-11. doi: 10.1016/j.chroma.2011.04.064. Epub 2011 May 6.
Clinical trial NCT05246241: Preoperative Magnetic Resonance Imaging Abnormalities Predictive of Lumbar Herniation Recurrence
Official title: Preoperative Magnetic Resonance Imaging Abnormalities Predictive of Lumbar Herniation Recurrence Following Surgical Repair
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lumbar Disc Herniation
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2022-02-18
Enrollment: 188
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 18-75 male and female single-level lumbar disk herniation

Brief summary: There are currently no standard criteria for evaluating the risk of recurrent disk herniation following surgical repair. This study investigated the predictive values of five presurgical imaging parameters, paraspinal muscle quality, annular tear size, Modic changes, modified Pfirrmann's disc degeneration grade, and presence of sacralization or fusion.

Clinical status and MRI findings were evaluated before surgery and 4, 12, and 24 months post-surgery using a Visual Analog Scale (VAS), Oswestry Disability Index (ODI), and Short Form 36 (SF36).


Eligibility criteria: Inclusion Criteria:

* first operation for a single-level lumbar disk herniation
* no concurrent spinal pathology such as stenosis, spondylolisthesis, or deformity
* complete data on clinical and radiological parameters

Exclusion Criteria:

* the operation was for multi-level pathologies
* recurrent surgery
* exhibited concurrent spinal pathology
* was missing or incomplete clinical and radiological data

Primary outcomes:
measure: Paraspinal muscle quality
timeFrame: Preoperative 1 month
measure: Annular tear size
timeFrame: Preoperative 1 month
measure: Modic changes
timeFrame: Preoperative 1 month
measure: Disc degeneration grade
timeFrame: Preoperative 1 month
measure: sacralization or fusion
timeFrame: Preoperative 1 month
Secondary outcomes:
measure: Visual Analog Scale
timeFrame: 4, 12, and 24 months after surgery
measure: Oswestry Disability Index (ODI)
timeFrame: 4, 12, and 24 months after surgery
measure: Short Form 36 (SF36)
timeFrame: 4, 12, and 24 months after surgery
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Ataturk University
state: Yakutiye
Study officials:
References:
citation: Ammerman J, Watters WC, Inzana JA, Carragee G, Groff MW. Closing the Treatment Gap for Lumbar Disc Herniation Patients with Large Annular Defects: A Systematic Review of Techniques and Outcomes in this High-risk Population. Cureus. 2019 May 7;11(5):e4613. doi: 10.7759/cureus.4613.
citation: Parker SL, Mendenhall SK, Godil SS, Sivasubramanian P, Cahill K, Ziewacz J, McGirt MJ. Incidence of Low Back Pain After Lumbar Discectomy for Herniated Disc and Its Effect on Patient-reported Outcomes. Clin Orthop Relat Res. 2015 Jun;473(6):1988-99. doi: 10.1007/s11999-015-4193-1.
Clinical trial NCT06009341: Effectiveness of Relaxation Methods in Total Knee Arthroplasty Patients
Official title: The Effect of Pain Management, Relaxation and Fall Training on Clinical Parameters in Total Knee Arthroplasty Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Knee Arthroplasty
Lead sponsor: Muğla Sıtkı Koçman University
Sponsor class: OTHER
First posted: 2023-08-24
Enrollment: 34
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study, the effectiveness of a comprehensive training program consisting of pain management, relaxation, breathing, massage and falling components will be investigated in patients with total knee arthroplasty. In this randomized controlled study, the trainings will be offered face-to-face after the initial evaluation and within the scope of telemedicine with prepared videos. The first evaluation will be performed on the first postoperative day and the last evaluation will be performed 3 months postoperatively. The aim of this study is to evaluate the effectiveness of a comprehensive education program consisting of pain management, relaxation, respiration, massage and fall components in patients with total knee arthroplasty.


Eligibility criteria: Inclusion Criteria:

* Participants aged 50 and over
* Participants indicated for unilateral or bilateral total knee arthoplasty
* Individuals to be followed after surgery

Exclusion Criteria:

* Other surgeries
* Individuals with neurological and orthopedic diagnoses
* Individuals with cognitive, hearing, speech and psychiatric problems that prevent them from communicating
* Illiterate individuals
* Presence of malignancy
* Not signing the consent form

Primary outcomes:
measure: Knee Society Short Form (KSSF)
timeFrame: Change from Baseline KSSF at 12 weeks
measure: Visual Analog Scale (VAS)
timeFrame: Change from Baseline VAS at 12 weeks
measure: Tampa Scale for Kinesiophobia (TSK)
timeFrame: Change from Baseline TSK at 12 weeks
measure: EQ-5D-3L Quality of Life Scale
timeFrame: Change from Baseline EQ-5D-3L at 12 weeks
measure: Pain Catastrophising Scale (PCS)
timeFrame: Change from Baseline PCS at 12 weeks
measure: Activity Specific Balance Confidence Scale (ABC)
timeFrame: Change from Baseline ABC at 12 weeks
measure: Fear of Falling Avoidance Behavior Questionnaire (FFABQ)
timeFrame: Change from Baseline FFABQ at 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Muğla
country: Turkey
facility: Muğla Sıtkı Koçman Training and Research Hospital
state: Menteşe
Study officials:
affiliation: Muğla Sıtkı Koçman University
name: Fatih Özden, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00993941: Bone Mesenchymal Stem Cell (BMSC) Transplantation in Liver Cirrhosis Via Portal Vein
Official title: Evaluation the Efficacy and Safety of Autologous Bone Marrow Mesenchymal Stem Cells (MSCs) Transplantation in Patients With Early and Middle Stage of Liver Cirrhosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Liver Cirrhosis
Keywords: BMSC
Stem cells
Liver cirrhosis
Transplantation
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2009-10-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the therapeutic efficacy of autologous bone marrow mesenchymal stem cells (BMSCs) transplantation via portal vein in patients with early and middle stage of liver cirrhosis on the basis of HBV infection. The evaluation of the efficacy includes the level of serum alanine aminotransferase (ALT), aspartate aminotransferase(AST), total bilirubin (TB),prothrombin time (PT), albumin (ALB), prealbumin(PA), precollagenⅢ(PCⅢ), collagenⅣ(Ⅳ-C), laminin(LN), hyaluronidase(HN), liver histological improvement before and 1 week to 1 year after transplantation. Child-Pugh scores and clinical symptoms were also observed simultaneously.


Eligibility criteria: Inclusion Criteria:

* Aged 18\~60 years.
* Serum HBsAg positive.
* Ultrasonographic evidences of cirrhosis.

Exclusion Criteria:

* history of moderate to severe hepatic encephalopathy or variceal bleeding during the last two months before enrolment.
* Prothrombin time is less than 30s.
* Cirrhosis caused by other reasons except HBV infection.
* Severe problems in other vital organs(e.g.the heart,renal or lungs).
* Liver tumor on ultrasonography, CT or MRI examination.
* Pregnant or lactating women.
* Imaging evidences of vascular thromboses.

Primary outcomes:
measure: The levels of serum alanine aminotransferase (ALT), total bilirubin (TB),prothrombin time (PT), albumin (ALB), prealbumin(PA), precollagenⅢ(PCⅢ), collagenⅣ(Ⅳ-C), laminin(LN), hyaluronidase(HN), liver histological improvement.
timeFrame: pre-transplantation, and 1week to 1 year post-transplantation
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: SunYat-sen University
name: Lin B liang, MD/PHD
role: PRINCIPAL_INVESTIGATOR
References: