louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06137274: Pilot Trial of Adaptive Radiotherapy Boost for HNSCC
Official title: Pilot Trial of Adaptive Radiotherapy Boost for Head and Neck Squamous Cell Carcinomas
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Squamous Cell Carcinoma
Head and Neck Cancer
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to determine if it is feasible to use magnetic resonance imaging (MRI) to adjust a portion of radiation therapy for patients with head and neck squamous cell carcinoma . The technique under study will be used to personalize the study treatment based on response, keeping all treatments within standard of care guidelines.


Eligibility criteria: Inclusion Criteria:

* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study
* ECOG performance status of 0, 1
* Patients with histologically or cytologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, nasopharynx, hypopharynx, larynx, or unknown primary in the neck.
* Patients with measurable disease, either at primary site or neck per RECIST 1.1.
* For patients planned to receive chemotherapy, adequate hematologic, hepatic and renal function as outlined in protocol.
* International normalized ratio of prothrombin time (INR) and prothrombin time (PT) within 28 days before randomization must be WNL for the lab. Patients who are therapeutically treated with an agent such as warfarin may participate if they are on a stable dose and no underlying abnormality in coagulation parameters exists per medical history.
* Negative serum pregnancy test within before starting study treatment in woman with childbearing potential.

Exclusion Criteria:

* Pregnancy or lactation
* Patients who have had prior radiotherapy to the head and neck or prior systemic therapy for the index cancer.
* Patients who had undergone definitive surgery for the index cancer.
* Patients with distant metastatic disease
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements.

Primary outcomes:
measure: Improvement in Mean OAR Dose Reduction
timeFrame: Up to 15 months
Secondary outcomes:
measure: Percentage of patients achieving a complete anatomic response
timeFrame: Up to 15 months
measure: Percentage of patients achieving a complete metabolic response
timeFrame: Up to 15 months
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
Study officials:
affiliation: Moffitt Cancer Center
name: George Yang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01886274: Does tDCS is Effective in the Prophylactic Treatment of Migraine
Official title: Transcranial Direct Current Stimulation in the Visual Cortex of Migraine Patients: Neurophysiological and Clinical Implications
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Migraine
Keywords: EEG
migraine
pain
phosphene
tDCs
TMS
Lead sponsor: Universidade Federal de Pernambuco
Sponsor class: OTHER
First posted: 2013-06-25
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Migraine has been described as one of the most common neurological diseases, with high social and economic impact. Despite the high prevalence, the pathophysiology of migraine is still unknown, several studies have been developed in order to advance the understanding of the pathophysiological mechanisms of the disease which are not yet entirely elucidated. The aim of this study is to observe the effects of transcranial direct current stimulation (tDCS), applied in the visual cortex, on neurophysiological and clinical measures (frequency, intensity, duration of attacks and severity of pain) in migraine patients.


Eligibility criteria: Inclusion criteria for migraine patients:

* Age must be between 18 to 40 years
* Gender: male and female
* Diagnosis must meet the 2004 IHS criteria for migraine without aura and migraine with aura
* Duration of the disease must be at least 12 months
* Patients had no preventative medication consistently for at least six months prior to study initiation.

Inclusion criteria for healthy individuals

* Age must be between 18 to 40 years
* Gender: male and female
* Individuals who have not filed headache crisis in the last year assessed according to the 2004 IHS criteria

Exclusion criteria

* Pregnant woman
* Individuals with clinical evidence of brain injury
* Metallic implant head
* Pacemaker
* History of seizure and chronic pain associated with other pathologies

Primary outcomes:
measure: Change from phosphene threshold
timeFrame: At baseline,1 month, 2 months, 3 months/ per session - at baseline and 30 minutes (after tDCS)
Secondary outcomes:
measure: Change from eletroencephalography
timeFrame: At baseline, 1 month and 2 months, 3 months
measure: Change from pain diary
timeFrame: 3 followed months
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: Applied Neuroscience Laboratory-LANA
state: Pernambuco
Study officials:
References:
Clinical trial NCT00250874: Myocet, Docetaxel & Trastuzumab as 1st Line Treatment of Patients With HER-2/Neu Positive Metastatic Breast Cancer
Official title: Phase I-II Study of Liposomal Doxorubicin (Myocet®), Docetaxel and Trastuzumab as First-Line Treatment of Patients With HER-2/Neu Positive Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Metastatic Breast Cancer
Lead sponsor: Zeneus Pharma
Sponsor class: INDUSTRY
First posted: 2005-11-08
Enrollment: 45
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To study the pharmacokinetic profile of the therapeutic schedule in order to demonstrate absence of negative interactions among the 3 drugs administered

Detailed description: 1. To assess the maximum tolerated dose (MTD) of Myocet at different dosages in combination with Taxotere at the fixed dose of 35 mg/m2 on day 2 and 9 every 21 days and weekly Herceptin as first line therapy in patients affected by HER-2/neu positive metastatic breast cancer
2. To enhance the proportion of complete remission
3. To allow the feasibility of the combination of Herceptin with both Myocet and Taxotere without an enhanced risk of cardiotoxicity

Eligibility criteria: Inclusion Criteria:

* HER-2/neu overexpression assessed by FISH test or with immunohistochemical methods: Dako(the result must be 3+ with dakotest); if the immunohistochemical test results 2+ it is needed a positive FISH test
* Female \< 70yrs
* Histologically or cytologically proven breast cancer.
* Metastatic or locally advanced breast cancer (clinical stage: III-IV)
* Adequate hematological, hepatic, renal and cardiac function, the latter confirmed by echocardiography with FEVS ≥50%
* Prior adjuvant chemotherapy if doxorubicin total dose ≤300 mg/m2, epirubicin total dose ≤450 mg/m2

Exclusion Criteria:

* History of cardiopathy
* Severe hepatic and renal diseases
* Brain metastases as the only parameter of disease
* Contraindication to the use of corticosteroids as premedication
* Acute infectious diseases
* Insulin-dependent diabetes
* History of other cancers except for adequately treated basal cell skin cancer or in situ carcinoma of the cervix
* Concurrent treatment with any other cancer therapy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Forli
country: Italy
facility: Ospedale Pietrantoni
Study officials:
affiliation: Ospedale Pietrantoni, Forli, Italy
name: Professor Amadori
role: PRINCIPAL_INVESTIGATOR
affiliation: San Filippo Neri, Rome, Italy
name: Professor Gasparini
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01734174: Left Ventricular Volume and Ejection Fraction: Validation of Real Time 3 Dimensional Transesophageal Echocardiography
Official title: Left Ventricular Volume and Ejection Fraction: Validation of Real Time 3 Dimensional Transesophageal Echocardiography
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: 3D Transesophageal and Transthoracic Echocardiogram
Keywords: transesophageal and transthoracic echocardiogram
thermodilution
left ventricular volume
ejection volume
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2012-11-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients having elective coronary artery bypass grafting surgery, valve repair or replacement surgery, aortic repair or replacement surgery, or any combination of these surgeries.

Brief summary: Echocardiography is an ultrasound-based imaging technique which can be performed through the esophagus (which lies behind the heart) and through the chest wall; both TEE and TTE are performed routinely as a monitoring and diagnostic tool at different times in the course of one cardiac surgery. The purpose of the study is to compare these two methods of echocardiography and comparing them to the 2D TEE and TTE assessments, which are routinely performed simultaneously. The study will also compare the echocardiography data to a third technique, thermodilution, which measures cardiac function via a pulmonary artery catheter.


Eligibility criteria: Inclusion Criteria:

* Elective coronary artery bypass grafting surgery, valve repair or replacement surgery, aortic repair or replacement surgery, or any combination of these surgeries.
* 18 years or older

Exclusion criteria for thermodilution assessment are as follows:

* Moderate to severe tricuspid regurgitation
* Contraindications to pulmonary artery catheter placement based on the American Society of Anesthesiologist's 2003 Practice Guidelines for Pulmonary Artery Catheterization.

Exclusion criteria for performance of TEE:

* Contraindications to the performance of TEE based on the Journal of the American Society of Echocardiologists' 2011 recommendations and the American Society of Anesthesiologist Guidelines for Performance of Perioperative Transesophageal Echocardiography.
* Any degree of mitral regurgitation or aortic insufficiency above trace.

Exclusion criteria for performance of TTE, both 3D and 2D:

* Qualified echocardiographer absent or unavailable.

Primary outcomes:
measure: General heart function (Left ventricular volume and ejection fraction)
timeFrame: During cardiac surgery
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Meghann Fitzgerald, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05398874: Clinical Efficacy of Ginkgo Biloba Extract in the Treatment of Knee Osteoarthritis
Official title: Clinical Efficacy of Ginkgo Biloba Extract in the Treatment of Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: Kufa University
Sponsor class: OTHER
First posted: 2022-06-01
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess the efficacy and safety of the Ginkgo biloba extract in patients with Knee OA.


Eligibility criteria: Inclusion Criteria:

* patients 40-75 years old with knee OA.
* Grade II and Grade III according to the Kellgrenn-Lawrence (KL) grading system of radiographic OA.

Exclusion Criteria:

* Pregnancy, breastfeeding
* Liver or renal problems
* Patient taking any drug that might interact with Ginkgo extract (eg. warfarin, etc.)
* patient with cardiovascular or cerebral vascular disorders, uncontrolled diabetes, allergic to ginkgo, recent surgery or hospital admission, \>75 years old.
* Allergic or contraindicated to using NSAIDs

Primary outcomes:
measure: KOOS score
timeFrame: Changes occured : baseline , 2 weeks , 4 weeks ,and 8 weeks
Secondary outcomes:
measure: IL-6
timeFrame: Changes occured: baseline , 4 weeks,and 8 weeks
measure: TNF-alpha
timeFrame: Changes occured: baseline , 4 weeks,and 8 weeks
measure: urinary CTX-II
timeFrame: Changes occured :baseline , 4 weeks,and 8 weeks
Other outcomes:
Locations:
city: Najaf
country: Iraq
facility: Private Clinic
state: N/A (Outside Of US)
Study officials:
References:
Clinical trial NCT05084274: Optimising Preconceptual Health in Subfertile PCOS Patients Using a Lifestyle Modification Program
Official title: Optimising Preconceptual Health in Subfertile PCOS Patients. Implementation of a Lifestyle Modification Program Before Fertility Treatment, Impact on Health Related Quality of Life and Obstetric Outcome
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Infertility, Female
Polycystic Ovarian Syndrome
Lifestyle
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2021-10-19
Enrollment: 19
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients will be randomly assigned to a group where they undergo a 12-week lifestyle modification program prior to their fertility treatment, or a group where they are entitled to start their fertility treatment without prior lifestyle modification program.

Detailed description: When allocated to the control arm patients will receive the standard of care combined with the foreseen questionnaires and bio-electric impedance analysis for body composition and ergospirometry. When the patient is allocated to the interventional arm she will receive a 12-week lifestyle modification program prior to her fertility treatment. The lifestyle modification program will consist of dietary advice, advice for physical activity and emotional support. After the 12-week program the fertilty treatment will start as per routine practice. Questionnaires, ergospirometry and bio-electric impedance analysis will also be performed at the foreseen moments.

Eligibility criteria: Inclusion Criteria:

* Subfertile patients between \>18- \<38 years old requesting fertility treatment at our centre
* PCOS phenotypes A, B, C and D according to the NIH 2012 extension of the ESHRE/ASRM 2003 diagnostic criteria
* BMI \>27 and \<38 (Jiskoot et al. 2017)
* Nulliparous women
* Patient gives consent voluntarily

Exclusion Criteria:

Patients will be excluded if they:

* do not meet the ESHRE/ASRM 2003 diagnostic PCOS criteria
* Have a BMI \<27 and \>38 (Jiskoot et al. 2017)
* Need Surgical sperm retrieval
* Use donor eggs
* Need Pre-implantation genetic testing (PGT)
* Multiparous women
* cannot reliably fill out the questionnaires or comprehend the intervention, because of a language barrier

Primary outcomes:
measure: body weight
timeFrame: 12 weeks after start of intervention
measure: body composition
timeFrame: 12 weeks after start of intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Brussel
country: Belgium
facility: Universitair Ziekenhuis Brussel
Study officials:
affiliation: Universitair Ziekenhuis Brussel
name: Michel De Vos
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02074774: IntellO2 vs Manual Control for Optimizing Oxygenation in Infants
Official title: Comparison of the IntellO2 - Precision Flow Automatic FiO2 Controller to Manual Control for Optimizing Oxygenation in Preterm Infants Receiving High Flow Nasal Cannula Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oxygen Titration in Preterm Infants to Manage Lung Disease
Keywords: nasal cannula, high flow oxygen therapy, pulse oximetry
Lead sponsor: Vapotherm, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Ashford and St. Peter's Hospitals NHS Trust
name: Oxford University Hospitals NHS Trust
First posted: 2014-02-28
Enrollment: 36
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The overall objective of this study is to demonstrate that the IntellO2 device providing automated control of fraction of inspired oxygen (FiO2) adjustments in spontaneously breathing infants with fluctuating arterial blood oxygen saturation levels is safe and efficacious in the routine clinical environment. Specifically, it is hypothesized that the IntellO2 will perform as well or better than standard practice for maintaining infants' arterial blood oxygen saturation in a target range while minimizing the exposure to elevated levels of oxygen in the inspired gas.


Eligibility criteria: Inclusion Criteria:

1. Preterm infants being treated with high flow nasal cannula therapy
2. A need for supplemental oxygen as demonstrated by an required FiO2 \> 0.25 at enrollment
3. Requiring a flow rate of greater than 2 L/min such that the assumed inspired oxygen fraction matched delivered oxygen fraction (definition of HFNC).

Exclusion Criteria:

1. Major congenital abnormalities
2. Hemodynamic instability, defined as being outside of a normotensive range based on each infant's individual characteristics
3. Seizures
4. Ongoing sepsis
5. Meningitis
6. Clinician's concern regarding stability of the infant

Primary outcomes:
measure: Percent time in target range for oxygen saturation by pulse oximetry
timeFrame: 24 hrs
Secondary outcomes:
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals NHS Trust
state: Oxfordshire
city: Chertsey
country: United Kingdom
facility: Ashford and St. Peter's Hospitals NHS Trust
state: Surrey
Study officials:
affiliation: Ashford and St. Peter's Hospitals NHS Trust
name: Peter Reynolds, MB.BS PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Vapotherm, Inc.
name: George C Dungan, MPhil
role: STUDY_DIRECTOR
References:
citation: Reynolds PR, Miller TL, Volakis LI, Holland N, Dungan GC, Roehr CC, Ives K. Randomised cross-over study of automated oxygen control for preterm infants receiving nasal high flow. Arch Dis Child Fetal Neonatal Ed. 2019 Jul;104(4):F366-F371. doi: 10.1136/archdischild-2018-315342. Epub 2018 Nov 21.
Clinical trial NCT02810574: Combining Noninvasive Brain Stimulation and Cognitive Training on Tobacco Craving
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tobacco Use Disorder
Lead sponsor: Laval University
Sponsor class: OTHER
First posted: 2016-06-23
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine whether combining noninvasive brain stimulation with cognitive training can reduce craving in adults with tobacco use disorder.


Eligibility criteria: Inclusion Criteria:

* 20-60 years old
* Smoking \> 15 cigarettes per day
* Tobacco Use Disorder according to Diagnostic and Statistical Manual V criteria

Exclusion Criteria:

* Contraindications to noninvasive brain stimulation
* Psychiatric or neurologic condition

Primary outcomes:
measure: Changes in tobacco craving assessed by the Questionnaire of Smoking Urge
timeFrame: immediately before and immediately after the end of the noninvasive brain stimulation
Secondary outcomes:
Other outcomes:
Locations:
city: Quebec
country: Canada
facility: Centre Interdisciplinaire de Recherche en Réadaptation et Intégration
Study officials:
References:
Clinical trial NCT06291974: Ankle Foot Orthosis on Muscle Activity in Cerebral Palsy
Official title: Efficacy of Solid Versus Ground Reaction Ankle Foot Orthosis on Muscular Activity in Children With Spastic Diplegic in Cerebral Palsy
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cerebral Palsy Spastic Diplegia
Lead sponsor: Delta University for Science and Technology
Sponsor class: OTHER
First posted: 2024-03-04
Enrollment: 30
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: children diagnosed with cp spastic diplegia with postural instability will represent the sample of this study.

They will be selected from the clinic of faculty of physical therapy, delta university and my private clinic.

Brief summary: To compare the effect of solid ankle foot orthosis and ground reaction foot orthosis on the muscle activity in children with spastic diplegic cerebral palsy (Gross Motor Functional Classification Scale III).

Detailed description: Few studies have examined muscular activity via electromyography (EMG) during quiet standing in children with cp.

A few studies have examined the benefits of ground reaction ankle foot orthosis, showing that it could effectively reduce or eliminate the crouch position in children with spastic cerebral palsy however little is known about the benefits of GRAFOs on postural control mechanisms in static standing in children with CP.

Previous Studies suggested that appropriate tuning of ankle foot orthosis properties may reduce muscle demand for children with CP.

So, this study may be a guide in management of postural instability in children with spastic diplegic cerebral palsy in standing position.

Eligibility criteria: Inclusion Criteria:

* Spasticity level II in lower limb muscles according to Modified Ashworth Scale.
* Able to follow order.
* Aged from 6 to 12 years old.

Exclusion Criteria:

* Visual or obvious detected vestibular sensory disorders or cerebellar disease.
* Botox injection in the last 6 months.
* Cognitive deficits or disturbed conscious level.

Primary outcomes:
measure: muscle activity by Electromyography device
timeFrame: up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: