louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04393025: Endovascular Stenting of Medically Refractory ICASD (Clinical and Sonographic Study)
Official title: Endovascular Stenting of Medically Refractory Intracranial Arterial Stenotic (ICAS) Disease (Clinical and Sonographic Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Stroke, Ischemic
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2020-05-19
Enrollment: 50
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two armed medical study
Primary purpose: TREATMENT

Brief summary: Cerebral Endovascular Stenting of medically refractory Intracranial Stenotic Blood Vessels with Recurrent Ischemic Strokes patients

Detailed description: Fifty patients were enrolled with 25 underwent Intracranial Stenting 25 received optimal medicall treatment without stenting and comparative study of primary outcome was conducted

Eligibility criteria: Inclusion Criteria:

1. Patients age between 30-80 years.
2. Symptomatic ICAS: presented with TIA or stroke, attributed to 70%-99% stenosis of a major intracranial artery: Internal carotid artery (ICA), middle cerebral artery (MCA) \[M1segment\], vertebral artery (VA), or basilar artery (BA).
3. Patient with recurrent TIA or stroke despite medical therapy, including anti-coagulation or antiplatelet and control of all vascular risk factors (DM, HTN and Hyperlipidemia).

Exclusion Criteria:

1. Patients previously stented at the target lesion or had extracranial stenosis.
2. Patient with acute stroke (within two weeks from the onset).
3. Complete occlusion of the artery on the imaging assessment.
4. Massive cerebral infarction (more than half the MCA territory), intracranial hemorrhage, epidural or subdural hemorrhage, and intracranial brain tumor on CT or MRI scans.
5. Contraindications to antithrombotic and/or anticoagulant therapies.

Primary outcomes:
measure: Clinical improvement of IC stented patients in comparison to medically treated
timeFrame: 3 months
measure: Functional improvement of IC stented patients in comparison to medically treated
timeFrame: 3 months
measure: Blood flow velocity accrossed Stenotic Large IC Vessels in comparison to medically treated
timeFrame: 3 months
Secondary outcomes:
measure: No Recurrent Ischemic stroke in stented ICSD patients
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01529125: Safety and Metabolic Study of Highly Active Antiretroviral Therapy (HAART) in Malnourished Children With HIV
Official title: ART Pharmacokinetics, Mitochondrial Integrity, and Antioxidant Capacity in Severely Malnourished HIV-infected Malawian Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kwashiorkor
Marasmus
Severe Acute Malnutrition
HIV
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2012-02-08
Enrollment: 42
Sex: ALL
Minimum age (years): 6
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children aged 6-59 months with HIV and kwashiorkor and marasmus who are not currently on HAART will be recruited from the Nutritional Rehabilitation Unit at Queen Elizabeth Central Hospital in Blantyre, Malawi. Controls will be recruited from the outpatient cotrimoxazole clinic who are about to start on HAART for a non-nutritional reason.

Brief summary: It is unclear whether children with HIV and severe acute malnutrition can be started on highly active antiretroviral therapy (HAART) safely while they are still malnourished and the manner in which this therapy should start. This study will examine the safety, efficacy, and metabolism of children started on HAART while still severely malnourished.


Eligibility criteria: Inclusion Criteria:

* HIV-infected about to start on HAART for the first time
* 6-59 months old

Exclusion Criteria:

* also being treated for TB
* other chronic illness (e.g., congenital heart disease, cerebral palsy)

Primary outcomes:
measure: Pharmacokinetics
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Blantyre
country: Malawi
facility: Queen Elizabeth Central Hospital
Study officials:
affiliation: Washington University School of Medicine
name: Mark J Manary, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00582725: R-CHOP + GM-CSF for Previously Untreated LCL in Elderly
Official title: Phase II Trial of Rituximab-CHOP (R-CHOP) Plus GM-CSF for Previously Untreated Diffuse Large Cell Lymphoma in the Elderly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lymphoma, Large B-Cell, Diffuse
Keywords: DLBCL, Elderly
previously untreated DLBCL in the elderly
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2007-12-28
Enrollment: 38
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Patients will receive 6 to 8 cycles of R-CHOP (Rituximab, Cyclophosphamide, doxorubicin, vincristine, and prednisone), with GM-CSF.

Detailed description: The objective of this study is to estimate complete response rates for patients treated with this regimen, to assess overall response rates, event-free survival and overall survival; and to assess toxicities associated with R-CHOP + GM-CSF. Patients will receive 6 to 8 cycles of R-CHOP (Rituximab, Cyclophosphamide, doxorubicin, vincristine, and prednisone), with GM-CSF.

Eligibility criteria: Inclusion Criteria:

* Histologically confirmed, CD20+ B cell diffuse large cell lymphoma, with measurable or evaluable disease
* Having no prior chemotherapy, immunotherapy or radiotherapy except for one cycle of CHOP or R-CHOP.

Exclusion Criteria:

* Pregnant
* Hepatitis B Surface Antigen positive
* Have known CNS disease or HIV infection
* Have NY Classification III or IV disease.

Primary outcomes:
measure: Response Rate to Therapy
timeFrame: Dec 2005 approx
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: University Of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Brad Kahl, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kahl BS, Bailey HH, Smith EP, Turman N, Smith J, Werndli J, Williams EC, Longo WL, Kim KM, McGovern J, Jumonville A. Phase II study of weekly low-dose paclitaxel for relapsed and refractory non-Hodgkin's lymphoma: a Wisconsin Oncology Network Study. Cancer Invest. 2005;23(1):13-8.
Clinical trial NCT04750525: A Non-invasive Intervention (BreEStim) for Management of Phantom Limb Pain (PLP) After Limb Amputation (Experiment 1)
Official title: A Non-invasive Intervention (BreEStim) for Management of Phantom Limb Pain (PLP) After Limb Amputation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain Management
Keywords: Phantom Limb Pain
BreEStim
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: National Institute on Disability, Independent Living, and Rehabilitation Research
First posted: 2021-02-11
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the effectiveness of innovative intervention of breathing controlled electrical stimulation (BreEStim) and conventional electrical stimulation (EStim) in management of neuropathic phantom limb pain in patients after limb amputation.


Eligibility criteria: Inclusion Criteria:

* has phantom limb pain (PLP) after amputation of one limb, upper or lower limb;
* has chronic pain, \>3 months;
* is stable on oral pain medications at least two weeks. (patients are allowed to continue their pain medications, i.e., no change in pain medications.)

Exclusion Criteria:

* currently adjusting oral pain medications for their PLP;
* has pain, but not PLP (e.g., from inflammation at the incision wound of the residual limb);
* has a pacemaker, or other metal and/or implanted devices;
* has cognitive impairment from brain injury or are not able to follow commands, or to give consent;
* has amputation in multiple limbs;
* have asthma or other pulmonary diseases;
* are not medically stable;
* have preexisting psychiatric disorders;
* alcohol or drug abuse;
* have a history of seizures/Epilepsy, or taking benzodiazepines, anticonvulsants, and antidepressants.

Primary outcomes:
measure: Change in Pain Level as Measured by the Visual Analog Scale (VAS).
timeFrame: Baseline, 10 minutes after intervention
Secondary outcomes:
measure: Change in Sensation Threshold on Amputated Limb Measured by Electrical Sensation Threshold (EST)
timeFrame: Baseline, 5 minutes after intervention
measure: Change in Pain Threshold on Amputated Limb Measured by Electrical Pain Threshold (EPT)
timeFrame: Baseline, 5 minutes after intervention
Other outcomes:
measure: Difference in Heart Rate Variability (HRV) Measured by Electrocardiogram (ECG)
timeFrame: Baseline, 10 minutes after intervention
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Sheng Li, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01534325: Efficacy Study for SD Device
Official title: Efficacy Study of SD Device for Overweight and Obesity Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Overweight
Lead sponsor: Beck Medical Ltd.
Sponsor class: INDUSTRY
First posted: 2012-02-16
Enrollment: 150
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: The purpose of this study is to determine whether the SD unique device is effective in treatment of overweight and obesity.

Detailed description: Obesity and Overweight had become the number 1 health concern of the modern world. Over 1 Billion people worldwide are overweight or obese. Those who suffer from overweight or obesity are exposed to other severe illnesses such as: diabetes, cardiovascular disease and cancer.

Only few drugs and surgeries are currently available as approved treatments for those who wish to reduce weight.

The purpose of this study is to determine whether the SD unique medical device, is effective in treatment of overweight and obesity.

Eligibility criteria: Inclusion Criteria:

* BMI 30-41.99
* AGE 18-65 years

Exclusion Criteria:

* Pregnant Women,
* Type I and II diabetes,
* People with disfunctioning of thyroid gland
* Hypertension

Primary outcomes:
measure: Change from Baseline in Body Weight
timeFrame: once in every two weeks up to 13 weeks for each participant
Secondary outcomes:
measure: Change from Baseline in Waist Circumference
timeFrame: once in every two weeks up to 13 weeks for each participant
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Emek Medical Center
city: Petach Tikva
country: Israel
facility: Rabin Medical Center
Study officials:
affiliation: Rabin Medical Center
name: Dror Dicker, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04508725: Serial Ultrasound in Metastatic Renal Cell Carcinoma (mRCC)
Official title: Early Therapeutic Monitoring of Response to Therapy With Serial Ultrasound in Metastatic Renal Cell Carcinoma (mRCC)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Kidney Cancer
Renal Cell Carcinoma
Metastatic Renal Cell Carcinoma
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2020-08-11
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: To assess whether changes in quantitative tumor perfusion parameters after 3 weeks of treatment, as measured by power Doppler ultrasound, can predict initial objective response, defined by current standard-of-care, to therapy at 12 weeks after start of treatment


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Pathology-confirmed diagnosis of metastatic RCC
* At least one tumor lesion greater than 1 cm in diameter, amenable to ultrasound imaging
* Written informed consent.

Specific inclusion criteria:

* arm 1: planned to be treated with combination of VEGFR2 tyrosine kinase inhibitor (TKI) plus immune checkpoint inhibitor (ICI)
* arm 2: planned to be treated with non-ICI therapy

Exclusion Criteria:

-Any comorbid condition that, in the opinion of the treating provider or the Protocol Directors, compromises the participant's ability to participate in the study

Primary outcomes:
measure: Measure Initial Objective response
timeFrame: 12 weeks
Secondary outcomes:
measure: Relative change in tumor burden compared to baseline
timeFrame: 12 weeks
measure: Lesion response compared to baseline
timeFrame: 12 weeks
measure: Progression free survival (PFS)
timeFrame: 12 months
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Alice C Fan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Jeremy Dahl, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05058625: Influence of Latent Miofascial Trigger Points in the Vertical Jump in Female Voleyball Players
Official title: Influence of Latent Miofascial Trigger Points in the Vertical Jump in Female Voleyball Players
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sports Physical Therapy
Lead sponsor: University of Castilla-La Mancha
Sponsor class: OTHER
First posted: 2021-09-28
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the effects of dry needling of latent myofascial trigger points on vertical jump height in female volleyball players

Detailed description: Evaluate a sample of female volleyball players after using dry needling on latent myofascial trigger points and verify if it would have an improvement of the vertical jump

Eligibility criteria: Inclusion Criteria:

* Healthy female volleyball players
* No Lower limbs injuries in the last 6 months
* Presence of latent trigger points in gastrocnemius
* Familiar with performing CMJ test

Exclusion Criteria:

* Active trigger points in the lower limbs
* Any contraindication of usind dry needling
* Any pathology that prevented the performance of CMJ test

Primary outcomes:
measure: Vertical Jump
timeFrame: pre-intervention
measure: Vertical Jump
timeFrame: Immediately post-intervention
measure: Vertical Jump
timeFrame: 72 hours post-intervention
measure: Vertical Jump
timeFrame: one week post-intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Toledo
country: Spain
facility: Alberto Sánchez Sierra
Study officials:
References:
Clinical trial NCT02948725: Clinical Application of Cross-education During Stroke Rehabilitation
Official title: Clinical Application of Cross-education During Stroke Rehabilitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: University of Saskatchewan
Sponsor class: OTHER
Collaborators: name: Saskatchewan Health Research Foundation
name: Royal University Hospital Foundation
First posted: 2016-10-28
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Based on the current state of knowledge and gaps in the literature we will conduct an intervention study to explore novel treatment and rehabilitation of patients at Royal University Hospital (RUH) with motor deficits following stroke. This project has the following objectives:

1. To determine if cross-education, in addition to standard rehabilitation leads to better recovery of upper limb function for stroke patients with hemiparesis.
2. To incorporate functional brain activation as measured by functional magnetic resonance imaging (fMRI) to examine the neural mechanisms associated with changes in motor function of the paretic arm post-stroke.
3. To use diffusion tensor imaging (DTI) tractography to measure connectivity and examine the extent to which white matter tract thickness correlates with preserved motor output in patients post-stroke.


Eligibility criteria: Inclusion Criteria:

* 18 years or older
* within 18 months of stroke recovery
* medically stable
* ambulatory
* have moderate to severe upper limb hemiparesis as diagnosed by clinicians
* Consent

Exclusion Criteria:

* significant cognitive impairment or aphasia affecting understanding, as assessed by clinician
* severe upper limb spasticity preventing any movement of the proximal arm and shoulder
* diagnosis of hemorrhagic or bilateral stroke
* history of other severe upper limb musculoskeletal injury
* other neurological diseases
* intracranial metal clips or cardiac pacemaker, or anything that would preclude an MRI
* Any condition that would preclude the participant's ability to attend follow-up visits in the opinion of the Investigator

Primary outcomes:
measure: Motor function scores as assessed using the Fugl-Meyer Assessment
timeFrame: At 26 weeks
Secondary outcomes:
measure: grip and wrist strength
timeFrame: At 26 weeks
measure: volume of motor cortex activation
timeFrame: At 26 weeks
Other outcomes:
Locations:
city: Saskatoon
country: Canada
facility: Royal University Hospital
state: Saskatchewan
Study officials:
affiliation: University of Saskatchewan
name: Jon Farthing, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04013425: Socket Preservation Using the Ice Cream Cone Technique Versus Spontaneous Healing in Fresh Extraction Sockets.
Official title: Socket Preservation Using the Ice Cream Cone Technique Versus Spontaneous Healing in Fresh Extraction Sockets.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Socket Preservation
Keywords: Socket preservation
Alveolar Ridge Preservation
Ridge Preservation
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-07-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The research is about socket preservation using the ice cream cone technique including collagen membrane and xenograft compared to spontaneous healing.

Detailed description: Atraumatic extraction is done and the socket is either left for spontaneous healing or the ice cream cone technique using the collagen membrane and the socket is filled with xenograft.

Eligibility criteria: Inclusion Criteria:

* Single or double rooted teeth indicated for extraction
* Presence of a buccal defect.
* Maxillary and Mandibular Arches

Exclusion Criteria:

* Systemic conditions/disease that contraindicated surgery.
* Radiation therapy in the head and neck region or chemotherapy during the 12 months prior to surgery.
* Patients who have any habits that might jeopardize the osseointegration process, such as current smokers.
* Patients with parafunctional habits that produce overload on implant, such as bruxism and clenching.

Primary outcomes:
measure: Horizontal Bone Dimension from the CBCT in mm.
timeFrame: 3 months
Secondary outcomes:
measure: Buccal Vertical Bone Dimension
timeFrame: 3 months
measure: Palatal Vertical Bone Dimension
timeFrame: 3 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Andrew George
Study officials:
References:
citation: Tan-Chu JH, Tuminelli FJ, Kurtz KS, Tarnow DP. Analysis of buccolingual dimensional changes of the extraction socket using the "ice cream cone" flapless grafting technique. Int J Periodontics Restorative Dent. 2014 May-Jun;34(3):399-403. doi: 10.11607/prd.1605.
Clinical trial NCT06713525: Observational Copenhagen Pancreatic Cancer Study
Official title: Copenhagen Pancreatic Cancer Study (COPAN)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Pancreatic Cancer
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
First posted: 2024-12-03
Enrollment: 8000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with pancreatic cancer referred to Department of Oncology, Herlev Hospital, Denmark within the study period will be invited to participate.

Brief summary: The primary objective of the Copenhagen Pancreatic Cancer (COPAN) study is to describe the real-world population of patients with pancreatic cancer (PC). Larger sample of longitudinal real-world data provides a unique opportunity for comprehensive exploration of the diagnostic and treatment journey for individuals diagnosed with PC and allows to investigate treatment outcomes and associated prognostic factors. Furthermore, the study aims to identify determinants of treatment management and treatment outcomes, including patient-reported outcomes.

Detailed description: The study objective is to describe the real-world population of patients with pancreatic cancer by collecting longitudinal data that facilitates a more rigorous understanding of the PC. This research project will catalog different elements of a patient's diagnostic and treatment journey and identify unmet needs of patients with PC.

The study aims to:

1. To compile detailed demographic information of patients with PC.
2. To document and analyze the clinical and disease characteristics at the time of diagnosis and beyond.
3. To track various treatment modalities employed, including surgery, chemotherapy, and radiation therapy.
4. To assess short-term and long-term outcomes, including survival rates, complications, and quality of life.
5. To identify prognostic and predictive factors within the real-world cohort.

8. To investigate the impact of PC and treatment on patients' quality of life.

4 Study Design This study of patients with PC will employ both a prospective, observational design and retrospective design to capture real-world data relating to health status and/or the delivery of health care routinely collected from a variety of sources. Data will be collected longitudinally, allowing for a dynamic analysis of the disease trajectory.

Eligibility criteria: Inclusion Criteria:

Histologically confirmed pancreatic cancer

Exclusion Criteria:

* None

Primary outcomes:
measure: Overall survival
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: