louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04334408: Safety and Efficacy of Fremanezumab for Migraine in Adult CADASIL
Official title: A Phase II Double-Blinded Placebo Controlled Individual Subject Stepped Wedge Clinical Trial Evaluating the Safety and Efficacy of Fremanezumab for Migraine in Adult CADASIL
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Cadasil
Migraine
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-04-06
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Researchers are trying to find out more about the side effects of fremanezumab when treating patients with Cerebral Autosomal Dominant Arteriopathy with Subcortical Infarcts and Leukoencephalopathy (CADASIL) for migraine headaches.

Detailed description: Subjects will receive 4 to 20 weeks of placebo injections followed by 12 weeks of monthly administered fremanezumab by subcutaneous injection (225 mg split four weeks apart for 12 weeks). Following completion of the 12 weeks of therapy, the participant will return to placebo for the washout period. Both the patient and the investigator will be blinded to the timing of transition to and from placebo and the transition to and from fremanezumab.

Eligibility criteria: Inclusion Criteria

* Age 18 to 70 years old
* English speaking
* Diagnosis of CADASIL confirmed by presence of a pathogenic NOTCH3 gene mutation
* Diagnosis of migraine for at least 12 months and diagnosis of chronic migraine for at least 28 days according to the International Classification of Headache Disorders
* MIDAS score of \>10 points
* Ability to provide written informed consent

Exclusion Criteria

* History of ischemic stroke within 4 weeks of screening assessment
* Screening blood pressure \>150 mm Hg
* Use of onabotulinum toxin A 4 months prior to trial or other injectable/stimulatory/magnetic method of headache control
* Use of opiates or barbiturates 4 days prior to trial
* Patients with competing intracerebral pathology (e.g. history of intracerebral hemorrhage, multiple sclerosis)
* NYHA Class III or IV congestive heart failure
* History of myocardial infarction
* History of coronary bypass surgery or coronary stenting
* Pregnancy or breastfeeding
* Contraindication to undergoing brain MRI per standard clinical practice guidelines
* Vulnerable populations, including incarcerated inmates, dementia, and inability to provide consent

Primary outcomes:
measure: Change in migraine-related disability
timeFrame: Baseline, 2 week intervals up to 48 weeks
measure: Change in headache intensity
timeFrame: Baseline, 2 week intervals up to 48 weeks
measure: Adverse events
timeFrame: 48 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Mayo Clinic
name: James F Meschia
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04574323: Effects of a Paleolithic Lifestyle Intervention in Breast Cancer Patients Undergoing Radiotherapy
Official title: Short-term Effects of a Paleolithic Lifestyle Intervention in Breast Cancer Patients Undergoing Radiotherapy: A Pilot and Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Body Weight Changes
Keywords: Bioimpedance analysis
Body composition
Nutrition
Oncology
Paleolithic diet
Lead sponsor: MVZ Leopoldina GmbH
Sponsor class: OTHER
First posted: 2020-10-05
Enrollment: 13
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study aims to test the feasibility and effects of a dietary and physical activity intervention based on evolutionary considerations in an oncological setting.

Detailed description: A total of 13 breast cancer patients referred to our clinic for curative radiotherapy were recruited for this pilot study. The women were supposed to undertake a "Paleolithic lifestyle" (PL) intervention consisting of a Paleolithic diet and daily outdoor activity of at least 30 min duration while undergoing radiotherapy. Body composition was measured weekly by bioimpedance analysis. Blood parameters were assessed before, during, and at the end of radiotherapy. A control group on an unspecified standard diet (SD) was assigned by propensity score matching.

Eligibility criteria: Inclusion Criteria:

* Body mass index \>18 kg/m\^2
* Karnofsky performance index \>60

Exclusion Criteria:

* Metallic body parts
* Unable to comprehend the intervention

Primary outcomes:
measure: Dropout rate in the Paleolithic lifestyle intervention group
timeFrame: through study completion, an average of 5 weeks
measure: Longitudinal body composition changes
timeFrame: through study completion, an average of 5 weeks
measure: Change in vitamin D levels
timeFrame: through study completion, an average of 5 weeks
Secondary outcomes:
measure: Change in beta-hydroxybutyrate levels
timeFrame: through study completion, an average of 5 weeks
Other outcomes:
Locations:
city: Schweinfurt
country: Germany
facility: Leopoldina Hospital Schweinfurt, Department of Radiotherapy and Radiation Oncology
state: Bavaria
Study officials:
References:
citation: Klement RJ, Koebrunner PS, Krage K, Weigel MM, Sweeney RA. Short-term effects of a Paleolithic lifestyle intervention in breast cancer patients undergoing radiotherapy: a pilot and feasibility study. Med Oncol. 2020 Nov 28;38(1):1. doi: 10.1007/s12032-020-01443-0.
Clinical trial NCT02867423: Hypofractionated Radiation by CyberKnife as a Mean of the Tumor Site's Radiation After Conventional Breast Radiation.
Official title: PHASE II STUDY : Hypofractionated Radiation by CyberKnife as a Mean of Radiation of the Tumor Site After Conventional Breast Radiation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Centre Antoine Lacassagne
Sponsor class: OTHER
First posted: 2016-08-16
Enrollment: 29
Sex: FEMALE
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 CyberKnife (CK) has been developed recently. This is a linear accelerator carried by an industrial robot. It has, due to its tumor tracking capabilities and high accuracy, an interest in irradiation (boost) of tumor site after conventional irradiation. The radiation boost is currently issued by electrons, protons or brachytherapy. These techniques require several fractions and are associated with cutaneous toxicities and aesthetic problems. CK has an interest in reducing the number of fractions and a reduction of dose delivered to the skin.

CK has been used in a phase I protocol (CYBERNEO) with concomitant chemotherapy for inoperable breast tumors and has proven its effectiveness and safety of treatments.

The investigator is considering conducting a Phase II protocol to a single dose of 8 Grays issued by CK for boost to the tumor site after conventional breast irradiation.

The results, in terms of local control, will be evaluated on clinical monitoring.


Eligibility criteria: Inclusion Criteria:

1. unifocal breast cancer histologically proven
2. Age\> 18 years old, in good general condition (ECOG 0-2)
3. No cons-indication for radiotherapy
4. Patient who underwent lumpectomy and axillary dissection or sentinel node technique.
5. carcinoma histology ductal or lobular carcinoma
6. surgical margins microscopically without residual disease (\> 1 mm)
7. tumors classes T1 or T2, N0

Exclusion criteria

1. residual calcifications on X-ray examination
2. Inflammatory breast cancer, ductal (and / or in situ) and invasive lobular
3. multifocal breast Cancer
4. prior Breast radiotherapy
5. Patient who received chemotherapy

Primary outcomes:
measure: EORTC score for erythema, telangiectasia, edema, pain
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nice
country: France
facility: Centre Antoine LACASSAGNE
Study officials:
affiliation: Centre Antoine Lacassagne
name: Pierre Yves BONDIAU, md
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03101423: Monitoring of Chimerism After Transplantation in Patients With β Thalassemia Major and the Treatment Strategies for the Reduction of Chimerism
Official title: Monitoring of Chimerism After Transplantation in Patients With β Thalassemia Major and the Treatment Strategies for the Reduction of Chimerism
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Beta Thalassemia Major
Keywords: thalassemia
transplantation
chimerism
donor ymphocytes
Lead sponsor: First Affiliated Hospital of Guangxi Medical University
Sponsor class: OTHER
First posted: 2017-04-05
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Hematopoietic stem cell transplantation is currently the only way to cure thalassemia, one of its main obstacles is the rejection after transplantation, chimerism continued to decline, which eventually lead to transplant failure. chimerism is a key indicator of the succession of immune response, which is a key indicator for predicting the failure of hematopoietic stem cell transplantation and provides an important basis for early detection of rejection. Transplantation of continuous chimerism can detect early unstable chimeras and rejection.The chimerism rates after transplantation were continuously monitored using fluorescence labeled multiplex PCR amplification of short tandem repeats (STR-PCR)

,and then follow our STR different rates for early interventional therapy to prevent further reduction in chimerism leading to lead to graft failure.


Eligibility criteria: Inclusion Criteria:

1. Diagnosis of thalassemia major
2. There is no restriction on age or gender.
3. Underwent allogeneic hematopoietic stem cell transplantation, including sibling transplantation, unrelated transplantation and haploidentical transplantation.
4. On +45 day after transplantation, check patients with STR less than 80%.
5. Patients underwent reduce of dosage with a failure treatment by
6. Body condition score (ECOG score) is less than or equal to 1 point who meet follow-up conditions.

Exclusion Criteria:

Complicated with severe cardiac insufficiency and cardiac ejection fraction (EF) was lower than 50%. Complicated with severe pulmonary insufficiency (obstructive and / or restrictive ventilatory disorders). Complicated with severe liver function damage and liver function index (ALT or TBIL) is more than 2 times of the upper limit of the normal value. Complicated with severe renal dysfunction and renal function index (Cr or BUN) is 2 times of the upper limit of the normal value. Complicated with severe active bleeding

Primary outcomes:
measure: Chimerism after transplantation were monitored using fluorescence labeled multiplex PCR amplification of short tandem repeats (STR-PCR)
timeFrame: Change from chimerism rate at 2-3 months after different treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Nanning
country: China
facility: the First Affiliated Hospital of Guangxi Medical University
state: Guangxi
Study officials:
References:
Clinical trial NCT03928223: The Color of Itch; Itch Modification by Color Viewing
Official title: The Color of Itch; Itch Modification by Color Viewing- an Exploratory Survey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Itch
Pruritus
Keywords: contagious itch
Manchester Color Wheel
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2019-04-26
Enrollment: 72
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Dermatology in- and outpatients with itch in the Department of Dermatology of the University Hospital Basel.

Brief summary: Itch is the commonest skin-related symptom. There is increasing evidence that itch can be influenced by visual cues. The impact of colors on itch has not yet been studied.

This study investigates Itch modification by color viewing and whether patients can match or counteract their itch with a color.


Eligibility criteria: Inclusion Criteria:

* Dermatology in- and outpatients with itch

Exclusion Criteria:

* color blindness
* lack of time
* lack of German language.

Primary outcomes:
measure: Change in itch intensity
timeFrame: assessed at baseline and again after the patients looked at the "antipruritic" color for 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Department of Dermatology, University Hospital Basel
Study officials:
affiliation: Department of Dermatology, University Hospital Basel
name: Simon Müller, Dr. med
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01394523: Caudal Versus Rectus Sheath Study
Official title: A Prospective, Double-blinded, Randomized Comparison of Caudal Analgesia Versus Ultrasound Guided Rectus Sheath Blocks for Umbilical Herniorrhaphy in the Pediatric Population
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Umbilical Hernia
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2011-07-14
Enrollment: 39
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The literature has clearly demonstrated that the effective treatment of postoperative pain in infants and children is challenging. In an effort to improve postoperative analgesia while limiting opioid-related adverse effects, there continues to be an increased use of regional anesthetic techniques in infants and children. Although the pediatric caudal remains the most commonly used pediatric regional anesthetic technique, it has been demonstrated that effective analgesia can be provided with the use of peripheral nerve blockade even in the pediatric-aged patient. The purpose of this study is to prospectively compare post-operative pain relief in pediatric patients undergoing umbilical hernia repair who have received either a caudal block or bilateral rectus sheath blocks for analgesia


Eligibility criteria: Inclusion Criteria:

* ASA physical status I or II
* Weight less than or equal to 20 kg
* Presenting for repair of umbilical hernia

Exclusion Criteria:

* ASA physical status \> II
* Weight greater than 20 kg
* Co-morbid diseases (cardiac, pulmonary, neurological disease)
* Patients having concomitant procedures (circumcision, orchiopexy, etc.)

Primary outcomes:
measure: Post-operative Pain Score
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
References:
Clinical trial NCT00372723: Study of a Potential New Treatment for Patients With Toxic Epidermal Necrolysis (TEN)
Official title: Pilot Study Comparing Remicade (Infliximab) vs. Standard Care in the Treatment of Toxic Epidermal Necrolysis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Toxic Epidermal Necrolysis
Keywords: toxic epidermal necrlysis
ten
Lead sponsor: Loyola University
Sponsor class: OTHER
First posted: 2006-09-07
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To determine whether treatment of patients who have toxic epidermal necrolysis with a drug called remicaide increases the number of patients who are alive 30 days laters.

Detailed description: This is a pilot (preliminary) study. Patients with a diagnosis of TEN will be asked to consider participating. The study intervention is a single intravenous dose of remicaide (5 mg/kg). Standard supportive care will be given. The percentage of patients alive at 30 days after treatment with remicaide will be compared to historical controls.

Eligibility criteria: Inclusion Criteria:

* Admission to burn unit with a histologic diagnosis of TENs

Exclusion Criteria:

* Pregnancy
* hypersensitivity to remicaide
* history of heart failure
* documented bacteremia
* history of cancer
* inability to consent

Primary outcomes:
measure: 30 day mortality
timeFrame: 30 days
Secondary outcomes:
measure: Safety labs and adverse events
timeFrame: 30 days
Other outcomes:
Locations:
Study officials:
affiliation: Loyola University Medical Center, Department of Surgery
name: Richard Gamelli, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01460823: Percutaneous Cochlear Implantation: Implementation of Technique
Official title: Percutaneous Cochlear Implantation: Implementation of Technique
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hearing Loss
Keywords: Hearing loss
Cochlear Implantation
Image guided surgery
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
First posted: 2011-10-27
Enrollment: 5
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: TREATMENT

Brief summary: The investigators are studying a new way of doing cochlear implant surgery called "Percutaneous Cochlear Implantation". In this surgery, instead of doing a mastoidectomy where about 30ml of bone is removed, the investigators use image-guided technology (similar to GPS systems used to guide automobile travel) to drill directly from the surface of the skull to the cochlea, removing less than 2ml of bone. To use this technique, three markers (or anchor screws) are screwed into the bone around the ear. Next, an x-ray of the head (called a CT scan) is taken. Using this CT scan, a path to the inner ear (cochlea) is planned and a drill guide (Microtable) is made that mounts on the anchor screws. A drill will be attached to the guide and used to drill a path from the surface of the skull to the inner ear (cochlea). The implant electrode will be threaded through this path. All of these procedures take place under general anesthesia.


Eligibility criteria: Inclusion Criteria:

* 18-80 year old patients undergoing cochlear implantation who are able to participate in the informed consent process.
* Pre-operative CT scan of head performed as standard of care for cochlear implant work-up.

Exclusion Criteria:

* Patients with co-morbidities so severe that the potential additional operating room time is deemed to be too significant of an operative risk. This assessment is made by the local institutions pre-operative work-up.
* History of allergic reaction/intolerance of local anesthesia and/or epinephrine.
* History of allergic reaction to titanium.
* Patients with severe anatomical abnormality of the temporal bone.
* Patients with severe chronic ear disease for whom traditional mastoidectomy might offer benefit.
* Females who are pregnant.

Primary outcomes:
measure: Percentage of participants who underwent successful Cochlear Implantation Via Percutaneous Method
timeFrame: Participants will be followed post operatively until their 1st follow up visit with surgeon which on average is 3 weeks after surgery.
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Robert F. Labadie, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04368923: Management of Covid-19 Patients During Home Isolation
Official title: Management of Covid-19 Patients During Home Isolation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Covid 19
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-04-30
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will be concerned with managing patients of Covid-19 while being home isolated.


Eligibility criteria: Inclusion Criteria:

* Patients with Covid-19
* American Society of Anesthesiologists (ASA) class I
* \>= 21 years old
* \<= 40 years old

Exclusion Criteria:

* ASA class II, class III or class IV

Primary outcomes:
measure: Arterial Blood Gases (ABG): Partial Pressure of Oxygen and Carbon Dioxide
timeFrame: 48 hours
measure: Arterial Blood Gases (ABG): Acidity Potential Hydrogen (pH)
timeFrame: 48 hours
Secondary outcomes:
measure: Vital Signs (Temprature)
timeFrame: 24 hours
measure: Vital Signs (Respiratory Rate)
timeFrame: 24 hours
measure: Vital Signs (Oxygen Saturation)
timeFrame: 24 hours
measure: Vital Signs (Heart Rate)
timeFrame: 24 hours
measure: Vital Signs (Blood Pressure)
timeFrame: 24 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: M. Sedky
Study officials:
References:
citation: Adly AS, Adly MS, Adly AS. Telemanagement of Home-Isolated COVID-19 Patients Using Oxygen Therapy With Noninvasive Positive Pressure Ventilation and Physical Therapy Techniques: Randomized Clinical Trial. J Med Internet Res. 2021 Apr 28;23(4):e23446. doi: 10.2196/23446.
Clinical trial NCT02338323: Compare the Renal Protective Effects of Febuxostat and Benzbromarone
Official title: Compare the Renal Protective Effects of Febuxostat and Benzbromarone in Chronic Kidney Disease Patients With GFR 20-50ml/Min
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Disease
Hyperuricemia
Abnormal Renal Function
Keywords: Hyperuricemia
Renal Function
Chronic kidney disease
Febuxostat
Benzbromarone
Lead sponsor: Shanghai 10th People's Hospital
Sponsor class: OTHER
First posted: 2015-01-14
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
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 febuxostat and benzbromarone could protect renal function, and which one could be better.

Detailed description: Chronic kidney disease patients with hyperuricemia and glomerular filtration rate (GFR) 20-50 ml/min were treated by febuxostat or benzbromarone. Follow up the changes of serum uric acid, serum creatinine and GFR levels. Compare the effects on renal function of these two drugs.

Eligibility criteria: Inclusion Criteria:

Chronic kidney disease patients with glomerular filtration rate (GFR,20-50ml/min) who match one of the following criteria:

1. Gout
2. Hyperuricemia patients without gout but have cardiovascular risk and serum uric acid \> 480umol/L
3. Hyperuricemia patients without gout but with serum uric acid \> 540umol/L

Exclusion Criteria:

1. GFR\<20ml/min or GFR \>50ml/min
2. Liver dysfunction (Aspartate transaminase or/and alanine aminotransferase exceed 2 times of normal range)
3. Urinary tract obstruction
4. unstable angina, heart failure (stage III-IV, NYHA), new stroke, need diuretics for long-term treatment
5. Severe lung diseases or cancers
6. Pregnant woman or woman who prepare to be pregnant，nursing mothers
7. unable to sign informed consent form，or disagree with following-up

Primary outcomes:
measure: Renal function
timeFrame: up to 12th months
Secondary outcomes:
measure: urine protein
timeFrame: 3rd months, 6th months, 9th months, 12th months
measure: adverse drug reaction
timeFrame: 1st month, 2nd months, 3rd months, 6th months, 9th months, 12th months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Nephrology & Rheumatology, Shanghai Tenth People's Hospital
state: Shanghai
Study officials:
affiliation: Department of Nephrology & Rheumatology, Shanghai Tenth People's Hospital
name: Ling Wang, MD, PhD
role: STUDY_CHAIR
References: