louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01834625: Prognostic Value of Aβ Imaging in NPH Prior to Shunt Placement
Official title: Prognostic Value of Aβ Imaging in NPH Prior to Shunt Placement
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Normal Pressure Hydrocephalus Patients
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2013-04-18
Enrollment: 2
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Clinically evaluated NPH patients

Brief summary: In this pilot study the investigators shall prospectively in a blinded fashion evaluate with Aβ PET in patients committed to shunt surgery and then investigate the relationship of these biomarkers with outcome on gait, cognition and urinary control improvement in the short term (3 months) and long term (1 year). The imaging agent will be provided by AVID.

Furthermore the study will standardize imaging studies using florbetapir F 18 PET to provide information on amyloid burden.


Eligibility criteria: Inclusion Criteria:

1. Age ≥ 60.
2. Visual and auditory acuity adequate for neuropsychological testing.
3. Completed six grades of education or has a good work history (sufficient to exclude mental retardation).
4. Must speak English fluently.
5. Willing to undergo one Amyloid imaging PET scan.
6. Agrees to at least one lumbar puncture for the collection of CSF.
7. Must agree to return for a Month 3 and Month 12 visit.
8. Participant, who in the opinion of the investigator, can tolerate the PET scan procedures

Exclusion Criteria:

1. History of schizophrenia (DSM IV criteria).
2. History of alcohol or substance abuse or dependence within the past 2 years (DSM IV criteria).
3. Participation in clinical studies involving neuropsychological measures being collected more than one time per year.
4. Exclusion for amyloid imaging with 18F -AV-45: Current or recent participation in any procedures involving radioactive agents such that the total radiation dose exposure to the participant in any given year would exceed the limits of annual and total dose commitment set forth in the US Code of Federal Regulations (CFR) Title 21 Section 361.1.
5. Clinically significant hepatic, renal, pulmonary, metabolic, or endocrine disturbances as indicated by history, which in the opinion of the investigator might pose a potential safety risk to the participant?
6. Current clinically significant cardiovascular disease, including one or more of:

   * cardiac surgery or myocardial infarction within the last 4 weeks;
   * unstable angina;
   * acute decompensated congestive heart failure or class IV heart failure

Primary outcomes:
measure: Comparison of change between florbetapir +ve and -ve patients from baseline to one year in the Montreal Cognitive Assessment (MoCA)
timeFrame: Baseline to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Neill R Graff-Radford, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03497325: Effect of Autologous Platelet-rich Plasma in Uterine Wound Healing
Official title: the Efficacy of Intramuscular Autologous Platelet-rich Plasma Injection on Uterine Wound Healing After Primary Cesarean Section
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cesarean Section Complications
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2018-04-13
Enrollment: 134
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the efficacy of intramuscular autologus platelet rich plasma on uterine wound healing after primary cesarean section

Detailed description: 110 pregnant female undergoing primary prelabor CS will be randomized to two groups group A)autologus PRP will be prepared from participant venous blood collected from the participants' arm into a syringe primed with ACD-A. then it will be injected into uterus after closing uterine incision . Injection sites will be selected near the incision at evenly 20 different sites

group B)normal saline 0.9 will be injected into uterus after closing uterine incision . Injection sites will be selected near the incision at evenly 20 different sites.

Eligibility criteria: Inclusion Criteria:

* Term pregnancy (gestational age between 37-41 weeks).
* Women undergoing cesarean section for the first time.
* Normal vaginal ultrasound examination and exclusion of any pelvic abnormality.
* Uncomplicated cesarean section.
* Lower uterine segment cesarean sections while the women not in labor

Exclusion Criteria:

* Women with complications during or after cesarean section as intrapartum or postpartum hemorrhage, puerperal sepsis, septic wound
* Women with medical diseases that can affect the healing as diabetes mellitus, anemia, chronic renal disease or hepatic disease or coagulopathy or receiving medications affect wound healing as corticosteroids or anticoagulant.
* Women who will use intrauterine device as a contraceptive method Women with uterine abnormality as cervical stenosis or fibroid uterus multiple gestation, placenta abruption, placenta previa, antepartum hemorrhage prolonged ROM, chorioamnionitis,meconium stained liquor

Primary outcomes:
measure: Presence of cesarean scar defect(niche)
timeFrame: 12 weeks after CS
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams university maternity hospital
Study officials:
References:
Clinical trial NCT06408025: Syrenity App for Depression
Official title: Mental Health-App for Improving Depressive Symptoms
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Depressive Symptoms
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Syra Health
First posted: 2024-05-09
Enrollment: 300
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 goal of this clinical trial is to learn if the Syrenity mental health app reduces depressive symptoms when compared to a control condition. Secondarily, the trial will provide data on the usability and acceptability of the Syrenity app. The main questions it aims to answer are:

Does Syrenity reduce self-reported depressive symptoms compared to a waiting list control? How usable is the Syrenity app?


Eligibility criteria: Inclusion Criteria:

* PHQ-9 \>= 10
* Use an iPhone or Android
* Residing in the United States

Exclusion Criteria:

* PHQ-9 item 9 \>= 2

Primary outcomes:
measure: Patient Health Questionnaire 9 (PHQ-9)
timeFrame: 6 weeks
Secondary outcomes:
measure: Generalized Anxiety Disorder Scale-7 (GAD-7)
timeFrame: 6 weeks
measure: Systems Usability Scale (SUS)
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Bloomington
country: United States
facility: Indiana University
state: Indiana
Study officials:
References:
Clinical trial NCT04322825: Mollii - Personalized Suit for Treatment of Spasticity, GFMCS 3-5
Official title: Mollii - Personalized Suit for Treatment of Spasticity, GFMCS3-5
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spastic Cerebral Palsy
Keywords: Mollii suit;
Goal Attainment Scale;
Reciprocal inhibition;
modified ashworth scale,
trans cutaneous electric stimulation, TENS
Spasticity reduction,
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
Collaborators: name: Eurostars
First posted: 2020-03-26
Enrollment: 31
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: prospective cohort study
Primary purpose: TREATMENT

Brief summary: The objective of this study was to examine the effect on spasticity and function of multifocal transcutaneous electrical stimulation incorporated in a 2-piece (Mollii) suit.

Detailed description: In this prospective cohort study, the participants (children with predominantly spastic CP, GFMCS 3-5) wore the suit for 1 hour every second day for 24 weeks. The investigators evaluated level of spasticity using the modified Ashworth scale (MAS) and other related measures before initiation, after 4, 12, and 24 weeks. Two motor related smart goals were defined and evaluated by the goal attainment scale (GAS). GMFM-66 and posture and postural ability scale (PPAS) were performed.

Eligibility criteria: Inclusion Criteria:

- cerebral palsy with spastic disease, GMFCS 3-5.

Exclusion Criteria:

* other disorders affecting the sensorimotor functions without spasticity,
* implanted electric medical devices,
* BMI\>35
* other severe concomitant diseases such as cancer, cardiovascular, inflammatory, psychiatric disease, medical dysregulated epilepsy or hypertension.

Primary outcomes:
measure: modified ashworth scale
timeFrame: 24 weeks
Secondary outcomes:
measure: Goal Attainment Scale
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: hospital of Hvidovre
Study officials:
References:
Clinical trial NCT02502825: Comparison of Methacholine Bronchial Provocation With Wright and Devilbiss646 Nebulizers
Official title: Comparison of 2-min Tidal Breathing Methacholine Bronchial Provocation With Wright and Devilbiss646 Nebulizers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Lead sponsor: Guangzhou Institute of Respiratory Disease
Sponsor class: OTHER
Collaborators: name: Firestone Institute for Respiratory Health
First posted: 2015-07-20
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to compare the diagnostic validity (sensitivity and specificity) and evaluate the safety of 2-min Tidal Breathing methacholine bronchial provocation tests with the Wright and Devilbiss646 nebulizers in asthmatic in Guangzhou.

Detailed description: After screening,each asthmatic patient will visit the investigators' center 4 times.

During the first week, the patient will be randomised to undergo methacholine bronchial challenge with Wright or Devilbiss 646 nebulizer on two separate days, which are at least 24 hours but not more than 7 days apart.The above procedure will be repeated for each patient in one month. But the nebulizer will be selected in a reverse order.Provocative concentration induced a 20% decrease in forced expiratory volume in one second (PC20) will be calculated for each test. Record all the adverse events during the tests.

Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of asthma;
* stable for more than 4 weeks with FEV1≥65%pred

Exclusion Criteria:

* exacerbation within 3 months;
* upper airway infections within 4 weeks;
* concomitant of hypertension or heart diseases;
* pregnancy;
* under immunotherapy

Primary outcomes:
measure: percentage of the participants that tested positive to methacholine bronchial provocation with Wright or Devilbiss646 nebulizer
timeFrame: 5 minutes after each challenge
Secondary outcomes:
measure: Incidence and severity of Adverse Events during the methacholine bronchial provocation tests with Wright nebulizer and Devilbiss646 nebulizer
timeFrame: during and until 5 minutes after each challenge
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangzhou institute of respiratory disease
state: Guangdong
Study officials:
affiliation: State Key Laboratory of Respiratory Disease; China Clinical Research Center of Respiratory Disease; First Affiliated Hospital of Guangzhou Medical University
name: Jinping Zheng
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02372825: Role of Free Iliac Crest Flap in Heel and Ankle Reconstruction
Official title: Role of Free Iliac Crest Flap in Heel and Ankle Reconstruction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Limb Salvage
Keywords: Free iliac crest transfer
Bone reconstruction
Ankle reconstruction
Heel reconstruction
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
Collaborators: name: University of Helsinki
name: University of Eastern Finland
First posted: 2015-02-26
Enrollment: 7
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Thirteen men patients with acute defects or sequela in the heel or ankle treated with the vascularized iliac crest transfer.

Brief summary: Treatment of extensive traumatic acute bone defects or sequela in heel or ankle poses a formidable challenge for the reconstructive surgeon. These defects can be treated with the vascularized iliac crest transfer. The purpose of this study is to assess the reliability and the long-term outcomes of free iliac crest flap transfer for these indications.

Detailed description: Thirteen patients were included in this study. Data was collected retrospectively from the patient records. The study design included three outcome measures to assess the clinical long-term outcomes. These were the Visual Analogue Scale Foot and Ankle (VAS FA), the Oswestry Disability Index (ODI), and the 15-dimensions (15D) health-related quality of life (HRQoL) instrument. The data was collected with postal approach and a written informed consent obtained from the seven participants.

Eligibility criteria: Inclusion Criteria:

* Patients with acute defects or sequela in the heel or ankle treated with the vascularized iliac crest transfer.

Exclusion Criteria:

1) Patients without treatment with the vascularized iliac crest transfer,

Exclusion criteria for the cross-sectional assessment:

1. deceased,
2. below-knee amputation,
3. permanent non-union

Primary outcomes:
measure: Visual Analogue Scale Heel and Ankle (VAS FA)
timeFrame: 2-26 years
measure: Oswestry Disability Index (ODI)
timeFrame: 2-16 years
measure: The 15-Dimensions (15D) health-related quality of life (HRQoL) instrument
timeFrame: 2-26 years
Secondary outcomes:
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Central Hospital
state: Uusimaa
Study officials:
affiliation: Department of plastic and reconstructive surgery, HUCS
name: Erkki J Tukiainen, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01659125: Effectiveness and Neuropsychological Predictors of Guided Self-Help for Obsessive-Compulsive Disorder (OCD)
Official title: Effectiveness and Neuropsychological Predictors of Guided Self-Help for OCD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obsessive-Compulsive Disorder
Lead sponsor: Hartford Hospital
Sponsor class: OTHER
First posted: 2012-08-07
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary aim of this study is to learn about who is most likely to benefit from guided self-help (GSH) for obsessive-compulsive disorder (OCD).

Detailed description: 40 Participants with OCD will be recruited. They will be given access to OC Fighter, an internet OCD treatment program. During the 17 week program, participants will meet with a therapist 9 times. Assessments will occur at pretreatment, post-treatment, 3-month follow up and 6-month follow up.

Eligibility criteria: Inclusion Criteria:

* Principal or co-principal diagnosis of OCD
* Clinical global impression score greater than or equal to 4
* Y-BOCS score great than or equal to 8
* Fluency in English
* Capacity to understand the nature of the study and willingness to sign informed consent form

Exclusion Criteria:

* Active manic episode, psychosis, pervasive developmental disorder, mental retardation
* Concurrent OCD psychotherapy
* Current threat of harm to self or others
* Previous adequate trial of therapist-administered or self-administered exposure and response prevention for OCD

Primary outcomes:
measure: Change in Yale-Brown Obsessive-Compulsive Scale (Y-BOCS)
timeFrame: Baseline (pretreatment), 17-weeks (posttreatment), and 6 month-follow-up
measure: Responder Status
timeFrame: Week 17 (post-treatment) and 6-month follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
Study officials:
affiliation: Hartford Hospital
name: Gretchen Diefenbach, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05114525: Analysis of Patient Understanding of Radiation Therapy Among Patients With Breast Cancer
Official title: Analysis of Patient Understanding of Radiation Therapy Among Patients With Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2021-11-10
Enrollment: 100
Sex: FEMALE
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 is to conduct a descriptive feasibility study of assessing how patients retain and understand information regarding radiation therapy obtained from an initial consult visit. This study will also pilot the use of visual aids and assess their utility to patients during a consult. The study will provide a baseline to conduct larger studies that will later incorporate additional patient education tools to assess changes in patient understanding of information received in radiation oncology patient consultations.


Eligibility criteria: Inclusion Criteria:

* Patients 18 years or older with non-invasive or invasive breast cancer receiving consultation at the breast radiation oncology clinic for radiotherapy recommendations

Exclusion Criteria:

* Patients under 18 years old or receiving palliative care

Primary outcomes:
measure: post-consultation telephone questionnaire
timeFrame: 10 days
Secondary outcomes:
measure: correlations between patient survey score as a measure of patient understanding
timeFrame: 10 days following consultation
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Kathleen Horst
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03421925: Effects of Using Divided Mesh and Using a Non Divided Mesh on Testicular Blood Flow and Volume in Laparoscopic Hernia Repair
Official title: Effects of Using Divided Mesh and Using a Non Divided Mesh on Testicular Blood Flow and Volume in Laparoscopic Hernia Repair
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hernia, Inguinal
Lead sponsor: Okan University
Sponsor class: OTHER
First posted: 2018-02-05
Enrollment: 150
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Laparoscopic inguinal hernia repair techniques has been compared with the open techniques in several studies. However, no one studied about the different uses of the same type of mesh on the same surgical technique, and effects of this different use on testicular volume and blood flow. The objective of this study is to investigate the effects at 6 months of the divided and non divided mesh in laparoscopic totally extraperitoneal hernia repair technique on testicular volume and blood flow by use of Doppler Ultrasonography


Eligibility criteria: Inclusion Criteria:

Patients with unilateral inguinal hernia Male patients

-

Exclusion Criteria:

Patients have femoral hernia Patients have bilateral inguinal hernia Patients have recurrent inguinal hernia Female patients Patients with history of pelvic surgery Patients with history of pelvic major trauma Patients with history of pelvic radiotherapy Patients have previous scrotal trauma or surgery history Patients have heavy cardiac diseases, pulmonary diseases Patients have benign prostate hyperplasia Patients have history of incarceration of inguinal hernia

-

Primary outcomes:
measure: Testicular volume
timeFrame: 6 months
Secondary outcomes:
measure: Testicular artery blood flow
timeFrame: 6 months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Okan University
Study officials:
References:
Clinical trial NCT00691925: Mitigating Pain Following Refractive Surgery
Official title: Contact Lens for Mitigating Pain Following Refractive Procedure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain
Keywords: refractive surgery
Lead sponsor: FORSIGHT Vision3
Sponsor class: INDUSTRY
First posted: 2008-06-06
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: at least 10 subjects following refractive surgery

Brief summary: Using Contact lens following refractive procedure to reduce pain.

Detailed description: Patients at day 1 following the procedure will be treated with a contact lens and assessed for pain at 1,2,4 hours and 1,3,5 days.

prospective comparative study

Eligibility criteria: Inclusion Criteria:

1. Patients who underwent bilateral Refractive surgery for myopic correction.
2. Age 18-60.
3. Evidence of an epithelial defect.
4. Patient complains of significant pain.
5. Patients able to understand the requirements of the study and willing to follow study instructions, to provide written informed consent to participate, and who agree to comply with all study requirements, including the required study follow-up visits.

Exclusion Criteria:

1. Any other anterior segment abnormality other than that associated with Refractive surgery.
2. Any abnormalities associated with the eye lids.
3. Prior laser treatment of the retina.
4. Any ophthalmic surgery performed within three (3) months prior to study excluding Refractive surgery.
5. Diagnosis of glaucoma.
6. Active diabetic retinopathy.
7. Clinically significant inflammation or infection within six (6) months prior to study.
8. Uncontrolled systemic disease (e.g., diabetes, hypertension, etc.) in the opinion of the Investigator.
9. Participation in any study involving an investigational drug within the past 30 calendar days, or ongoing participation in a study with an investigational material.
10. Intolerance or hypersensitivity to topical anesthetics,
11. Specifically known intolerance or hypersensitivity to contact lenses.
12. A medical condition, serious intercurrent illness, or extenuating circumstance that would significantly decrease study compliance, including all prescribed follow-up.
13. Any condition that, in the opinion of the investigator, would jeopardize the safety of the patient.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Sorasky Medical Center
Study officials:
affiliation: Sorasky Medical Center
name: David Verssano, MD
role: PRINCIPAL_INVESTIGATOR
References: