louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01552733: Robotic Therapy Early After Stroke Events
Official title: Robotic Therapy Early After Stroke Events
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: NHS Greater Glasgow and Clyde
Sponsor class: OTHER
Collaborators: name: University of Glasgow
First posted: 2012-03-13
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: Weakness and impairment of the upper limb is a common contributing factor to post stroke disability. Specially designed robotic systems have been developed to try to improve this. The investigators already know that their use helps improve limb function after stroke when it has been present for many months. The investigators do not know whether they can help early after stroke and enhance recovery of limb function, and perhaps prevent weakness becoming chronic.

The investigators plan a randomised controlled blinded study to explore the benefits of robot assisted therapy early after stroke in 80 stroke survivors. Participants will be randomised by 7 days after stroke to standard care or to robotic therapy (40 participants per study group).

Standard of care will be rehabilitation therapy according to local guidelines delivered by NHS multidisciplinary team.

Robotic therapy sessions lasts approximately one hour and consists of a series of tasks in first the unimpaired then impaired limb. The robotic-assisted therapy will consist of a series of taks including circle-drawing, reaching targets and holding/moving against moderate resistance. Twelve sessions of therapy within the first 4 weeks after randomisation will be delivered. This study will take 3 years to complete.


Eligibility criteria: Inclusion Criteria:

1. Aged \> 18 years
2. Confirmed diagnosis of stroke
3. Randomisation by seven days
4. Upper limb impairment, defined as a measurable upper limb impairment on the NIHSS and a baseline upper limb FuglMeyer score of \<50 at randomisation
5. Able to comply with the requirements of the protocol

Exclusion Criteria:

1. Other significant upper limb impairment e.g. fixed contracture, fracture, frozen shoulder, severe arthritis, amputation.
2. Diagnosis likely to interfere with rehabilitation or outcome assessments such as registered blind or terminal illness.
3. Participation in other stroke rehabilitation trial.

Primary outcomes:
measure: Fugl-Meyer score therapy.
timeFrame: One month
measure: Feasibility
timeFrame: One month
Secondary outcomes:
measure: Fugl-Meyer score.
timeFrame: Day 90
measure: Modified Rankin scale score
timeFrame: DAy 90
measure: Barthel index
timeFrame: Day 90
measure: Stroke Impact Scale
timeFrame: Day 90
measure: NIHSS
timeFrame: Day 90
measure: Action Research Arm Test
timeFrame: Day 90
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: Western Infirmary, NHS Greater Glasgow and Clyde
Study officials:
affiliation: University of Glasgow
name: Jesse Dawson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05755633: Role of Day +60 WT1 Assessment on Bone Marrow in Predicting Relapse and Mortality After Allogeneic Stem Cell Transplantation
Official title: Role of Day +60 WT1 Assessment on Bone Marrow in Predicting Relapse and Mortality After Allogeneic Stem Cell Transplantation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Assessment of the WT1 Expression Level on Bone Marrow Samples Collected at Day +60 After Allogeneic Stem
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-03-06
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This is a retrospective study which will be held on 50 patients with acute myeloid leukemia allografted in the transplant Units of Policlinico Agostino Gemelli in Rome, between June 2018 and July 2020, for whom WT1 level was assessed on bone marrow at day 60 after transplant.

The minimum follow up for surviving patients will be 60 days. Patients will be classified according to European Leukemia Net criteria

Brief summary: The rationale of this study is to determine if an association exists between WT1 expression and relapse occurrence in patients with acute myeloid leukemia submitted to allogeneic stem cell transplantation. In particular, we want to studied WT1 expression level on bone marrow samples of day +60 in terms of predicting power on relapse incidence so as to determine a cut-off value for identify high risk patients.

Detailed description: This is a retrospective study which will be held on 50 patients with acute myeloid leukemia allografted in the transplant Units of Policlinico Agostino Gemelli in Rome, between June 2018 and July 2020, for whom WT1 level was assessed on bone marrow at day 60 after transplant. The minimum follow up for surviving patients will be 60 days. Patients will be classified according to European Leukemia Net criteria. For each patient a total of 24 ml of bone marrow was collected at day +60 post transplant, whereas the same quantity of bone marrow was collected from healthy donor during bone marrow harvest procedure.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years Diagnosis of acute myeloid leukemia Patients received allogeneic stem cell transplantation Signed informed consent to storage and use biological samples for research scope Signed informed consent to privacy

Exclusion Criteria:

* Patients who had received a previous stem cell transplant Hematological disease other than acute myeloid leukemia Patient not studied for WT1 level at day +60 after transplant

Primary outcomes:
measure: we want to studied WT1 expression level on bone marrow samples of day +60 in terms of predicting power on relapse incidence so as to determine a cut-off value for identify high risk patients
timeFrame: day 60 after transplant
Secondary outcomes:
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Servizio E Dh Di Ematologia
Study officials:
References:
Clinical trial NCT05806333: [18F]FAPI PET/CT in Suspicious Focal Liver Lesions Without FDG Avidity
Official title: Diagnostic Performance of [18F]FAPI PET/CT in Suspicious Focal Liver Lesions Without FDG Avidity
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Liver Cancer
Lead sponsor: Jilin University
Sponsor class: OTHER
First posted: 2023-04-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Fibroblast activation protein (FAP) is a serine protease that belongs to the dipeptidyl peptidase-IV (DPP-IV) family located in fbroblast membranes. FAP is overexpressed in the cancer-associated fbroblasts (CAFs) of 90% of epithelial carcinomas, including primary and metastatic liver cancer. We aim to conduct a prospective study to investigate the diagnostic perfoemance of 18F-FAPI PET/CT in evaluating suspicious liver mass without FDG avidity.

Detailed description: Fibroblast activation protein (FAP) is a serine protease that belongs to the dipeptidyl peptidase-IV (DPP-IV) family located in fbroblast membranes. FAP is overexpressed in the cancer-associated fbroblasts (CAFs) of 90% of epithelial carcinomas, including primary and metastatic liver cancer. Therefore, FAP-targeted radiopharmaceuticals can be considered a promising approach for visualizing CAFs. CAFs are crucial components of the tumor stroma, promote the growth of cancer cells, and are associated with poor prognosis. Currently, 18F-labelled fbroblast activation protein inhibitor 18F-FAPI has shown promising diagnostic value in many types of tumors, especially those in which are not avid for 18F-FDF , and several studies have demonstrated that 18F-FAPI PET/CT is superior to 18F-FDG PET/CT for detecting liver cancer and has lower tracer uptake in normal liver tissue. We aim to conduct a prospective study to investigate the diagnostic performance of 18F-FAPI PET/CT in evaluating suspicious liver mass without FDG avidity.

Eligibility criteria: Inclusion Criteria:

* patients with suspected liver malignant lesions based on traditional diagnostic imaging (CT or MRI or ultrasound) and clinical symptoms;
* patients underwent \[18F\]FDG PET/CT with negative findings (suspicious primary and/or metastatic lesions were hypo- or isometabolic on \[18F\]FDG PET/CT);
* patients who agreed to undergo \[18F\]FAPI PET/CT scans within 1 week.

Exclusion Criteria:

* pregnancy;
* age\<18 years old;
* patients with chemo/radio/targeted therapy before scanning;
* inability to provide informed consent (signed by participant, parent, or legal representative).

Primary outcomes:
measure: Diagnostic performance of FAPI PET
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Chang chun
country: China
facility: China-Japan Union Hospital
state: Jilin
Study officials:
affiliation: China-Japan Union Hospital, Jilin University
name: Bin Ji
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00937833: Return of Continence Following Robot-Assisted Radical Prostatectomy With or Without a Urethrovesical Sling
Official title: Randomized Controlled Trial Examining the Return of Urinary Continence After Robot-assisted Radical Prostatectomy With or Without a Urethrovesical Sling
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence
Prostate Cancer
Keywords: prostate cancer
prostatectomy
incontinence
Lead sponsor: Cook Group Incorporated
Sponsor class: INDUSTRY
First posted: 2009-07-13
Enrollment: 150
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine the impact of an absorbable urethrovesical sling on the post-operative return of urinary continence after robot-assisted radical prostatectomy.


Eligibility criteria: Inclusion Criteria:

* Patients must have organ confined prostate cancer.
* Patients must have PSA\< 15.
* Patients must have clinical stage prostate cancer \< cT3.
* Patients must be scheduled for robot assisted transperitoneal laparoscopic radical prostatectomy.
* Patients must be able to provide written informed consent and HIPAA authorization for release of personal health information.
* Patients must be at least 18 years of age.

Exclusion Criteria:

* Patients must not have previously undergone transurethral resection, laser therapy, microwave therapy, radiofrequency ablation, or other surgery of the prostate.
* Patients must not have previously undergone incision of urethral stricture or incision of bladder neck contracture.
* Patients must not have previously been diagnosed with urethral stricture, bladder neck contracture or urinary incontinence.
* Patients must not have previously been diagnosed with atonic bladder or neurogenic bladder.
* Patients must not have significant pre-operative voiding symptoms as defined by an American Urologic Association symptom score of greater than 19.
* Patients must not have a prior history of radiation to the pelvis.
* Patients must not have persistent bacteriuria that cannot be cleared, as demonstrated by a negative urinalysis or urine culture, within 1 month of surgery.
* Patients must not have allergies to pig tissue or pig products or have religious or cultural objection to the use of pig tissue.

Primary outcomes:
measure: Number of Continent Patients Post Prostatectomy
timeFrame: 1 Month
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University School of Medicine
state: Indiana
city: San Antonio
country: United States
facility: Urology of San Antonio Research
state: Texas
Study officials:
affiliation: Indiana Cancer Pavilion
name: Chandru Sundaram, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05134233: Investigation of Low-intensity Focused Ultrasound Parameters
Official title: Investigation of Low-intensity Focused Ultrasound Parameters
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Development of LIFU for Clinical Purposes
Keywords: low-intensity focused ultrasound
transcranial magnetic stimulation
Lead sponsor: Virginia Polytechnic Institute and State University
Sponsor class: OTHER
First posted: 2021-11-24
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Multi-visit study, testing various LIFU parameters per session
Primary purpose: BASIC_SCIENCE

Brief summary: This project examines the effects of different brain stimulation settings on muscle contractions. The investigators believe this study will help to better understand noninvasive brain stimulation techniques that may have the potential to aid in addiction, pain, and mental health issues. Participants undergo structural imaging, an fMRI and CT. These images are used to align the low-intensity focused ultrasound (LIFU) and transcranial magnetic stimulation (TMS) devices to temporarily change brain activity. Electromyography (EMG) will be used to record muscle contractions on the hand.


Eligibility criteria: Inclusion Criteria:

* Above criteria and must understand and speak English.

Exclusion Criteria:

* Contraindications to MRI, CT, or TMS

  1. Claustrophobia
  2. Pacemaker, aneurysm clips, neurostimulators, cochlear implants, metal in eyes, steel worker, or other implants.
  3. Pregnancy
  4. Active medical disorder or treatment with potential CNS effects
  5. History of neurologic disorder
  6. History of head injury resulting in loss of consciousness for \>10 minutes
  7. History of alcohol or drug dependence
  8. Failure to provide a social security number or tax ID number. This is required for tax purposes or payment cannot be processed.

Primary outcomes:
measure: Waveforms
timeFrame: Outcome measured throughout study participation - an average of 4 weeks per participant.
Secondary outcomes:
Other outcomes:
Locations:
city: Roanoke
country: United States
facility: Fralin Biomedical Research Institute
state: Virginia
Study officials:
References:
citation: Legon W, Bansal P, Tyshynsky R, Ai L, Mueller JK. Transcranial focused ultrasound neuromodulation of the human primary motor cortex. Sci Rep. 2018 Jul 3;8(1):10007. doi: 10.1038/s41598-018-28320-1.
citation: Fomenko A, Chen KS, Nankoo JF, Saravanamuttu J, Wang Y, El-Baba M, Xia X, Seerala SS, Hynynen K, Lozano AM, Chen R. Systematic examination of low-intensity ultrasound parameters on human motor cortex excitability and behavior. Elife. 2020 Nov 25;9:e54497. doi: 10.7554/eLife.54497.
citation: Xia X, Fomenko A, Nankoo JF, Zeng K, Wang Y, Zhang J, Lozano AM, Chen R. Time course of the effects of low-intensity transcranial ultrasound on the excitability of ipsilateral and contralateral human primary motor cortex. Neuroimage. 2021 Nov;243:118557. doi: 10.1016/j.neuroimage.2021.118557. Epub 2021 Sep 4.
Clinical trial NCT02233933: Trial of Argon Plasma Coagulation Versus APC and APC and Hemospray in the Treatment of Radiation Proctitis
Official title: Randomized Trial of Argon Plasma Coagulation Versus Argon Plasma Coagulation and Hemospray in the Therapy of Radiation Proctitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rectal Bleeding
Keywords: radiation proctitis
bleeding
therapy
Lead sponsor: British Columbia Cancer Agency
Sponsor class: OTHER
First posted: 2014-09-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Randomized trial of Argon Plasma Coagulation compared with Argon Plasma Coagulation and Hemospray in the therapy of bleeding from Radiation Proctitis

Detailed description: 20 patients with Radiation Proctitis will be randomized to receive either Argon Plasma Coagulation therapy alone or therapy with APC followed by Hemospray administration ;the treatment in each arm is administered during a sigmoidoscopic examination

Eligibility criteria: Inclusion Criteria:

* bleeding from radiation proctitis

Exclusion Criteria:

* pregnancy bleeding diathesis

Primary outcomes:
measure: cessation of rectal bleeding
timeFrame: 12 months
Secondary outcomes:
measure: number of treatments required to achieve cessation of rectal bleeding
timeFrame: 12 months
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: British Columbia Cancer Clinic
state: British Columbia
Study officials:
affiliation: BCCA
name: Alan A Weiss, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06175533: Pain Improvement After Ultrasound Guided Continuous Radio Frequency 60 Degree for Plantar Fasciitis
Official title: Decrease in Pain Score After Ultrasound Guided CRF for Chronic Plantar Fasciitis Not Responding to Treatment in Addition to Ultrasound Changes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Plantar Fascitis
Lead sponsor: Iraqi Board of medical specialties
Sponsor class: OTHER
First posted: 2023-12-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: chronic plantar fasciitis not responding to classical injection by steroid or regenerative therapy
Primary purpose: TREATMENT

Brief summary: detailed changes after ultrasound guided cry for plantar fasciitis in regard pain score and plantar fascia AP diameter in ultrasound scan pre and 30 days post operation


Eligibility criteria: Inclusion Criteria:

* chronic plantar fasciitis not responding to treatment not responding to classical injection

Exclusion Criteria:

* torn plantar fascia

Primary outcomes:
measure: reduction in pain score
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Baghdad
country: Iraq
facility: Baghdad Medical City
Study officials:
References:
Clinical trial NCT01634633: Endometrial Nerve Fibers Detection in Patients With Different Gynecological Pathologies
Official title: Endometrial Nerve Fibers Detection in Patients With Different Gynecological Pathologies
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gynecological Pathologies
Keywords: Endometrial nerve fibres
Lead sponsor: Ain Shams Maternity Hospital
Sponsor class: OTHER
First posted: 2012-07-06
Enrollment: 300
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The population of this study will be 300 patient undergoing laparoscopy or laparotomy for different gynecological diseases namely, polycystic ovarian disease (PCOD), ovarian cysts either benign or malignant, fibroid uterus, adenomyosis, endometrial hyperplasia and endometrial carcinoma

Brief summary: The aim of this study is to investigate the prevelence of endometrial nerve fibers in different gynecological pathologies

Detailed description: The aim of this study is to investigate the prevelence of endometrial nerve fibers in different gynecological pathologies in addition to its relation to chronic pelvic pain

Eligibility criteria: Inclusion Criteria:

1. Age: 20-60 years of age.
2. Written and signed informed consent by the patient to participate in the study.
3. Women candidate for surgical intervention either via laparoscopy or laparotomy for different gynecological pathologies

Exclusion Criteria:

1. Suspected endometriosis.
2. Patient unwillingness to participate in the study.
3. No hormonal treatment for the last 6 months.
4. Suspected pregnancy.

Primary outcomes:
measure: Prevelencce of endometrial nerve fibers
timeFrame: 18 months
Secondary outcomes:
measure: Pelvic pain
timeFrame: 18 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain shams new maternity hospital
Study officials:
affiliation: Ain Shams University
name: Reda MK Ghanem, M.B.B.Ch
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03251833: The Impact of Obesity on Maternal and Perinatal Outcomes
Official title: The Impact of Obesity on Maternal and Perinatal Outcomes; Analytic Cross Sectional Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Obesity
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-08-16
Enrollment: 2000
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: women admitted to the emergency unit of Obstetrics and Gynaecology Department, Woman's Health Hospital

Brief summary: Body Mass Index is an index that is commonly used to classify underweight, overweight and obesity in adults. It is defined as the weight in kilograms divided by the square of the height in meters.The growing epidemic of obesity in our society has become a major public health issue where the proportion of overweight and obese among women aged 15-59 have increased from 68 percent in 2008 to 76 percent in 2015


Eligibility criteria: Inclusion Criteria:

* pregnant women
* single fetus
* gestational age \>28weeks

Exclusion Criteria:

* patient refusal
* multifetal pregnancy
* Medical illness prior to pregnancy.

Primary outcomes:
measure: The incidence of preeclampsia in both groups
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut Faculty of Medicine
Study officials:
References: