louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04504201: Patient-centered Communication About Healthy Weight in Early Breast Cancer
Official title: Clinic-based "Patient-Centered Communication About Healthy Weight" (PCC-HW) in a Diverse Sample of Women With Early Breast Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
name: Pfizer
First posted: 2020-08-07
Enrollment: 39
Sex: ALL
Minimum age (years): 21
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Breast Cancer patients and Breast oncology providers will be eligible for this study

Brief summary: Comorbidities in breast cancer survival account for 49% of overall survival difference between black and white women. Many obesity-related comorbidities disproportionately affect black women, therefore pointing to a need to address obesity related comorbidities in survival disparities in early breast cancer patients. This study tinvestigates how messages and messaging about healthy weight can be tailored for racially diverse breast cancer survivors with obesity in order to ensure that clinic-based communications between patients and their oncology provider are patient-centered and culturally sensitive.

Detailed description: The overall goal of this research is to collect essential input for the future development of a quality improvement intervention to foster "Patient-Center Communication about Healthy Weigh in clinical practice

Primary Objective:

1. Understand patient-centered perspectives on health weight communication with oncology clinicians by conducting focus groups

   Secondary Objective
2. Understand oncology clinician perspectives on patient center communications for healthy weight interactions through semi-structured interviews.

Eligibility criteria: Inclusion Criteria for Breast Cancer Cohort:

* Age 21 or older
* Diagnosed with early breast cancer, Stages I-III
* Completed primary treatment (Surgery, chemotherapy, radiation) within past 2 years
* Body mass Index of equal or greater than 30

Exclusion Criteria:

* Cannot understand and speak English

INclusion Criteria for Oncology provider cohort:

* Breast cancer oncology provider in North Carolina with MD/DO/PA/NP/RN
* associated with community-based practices

Primary outcomes:
measure: Feedback from patients regarding healthy weight communication through focus groups
timeFrame: 3 year
Secondary outcomes:
measure: Feedback from oncology providers regarding healthy weight communication through semi-structured interview
timeFrame: 3 year
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Kirsten Nyrop, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01778101: Lansoprazole in Preterm Infants With Reflux
Official title: A Pilot Study - Lansoprazole in Preterm Infants With Gastroesophageal Reflux
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Preterm Infants
Gastrointestinal Reflux
Keywords: preterm infants
reflux
impedance
pH
monitoring
lansoprazole
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2013-01-29
Enrollment: 5
Sex: ALL
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is pilot study to evaluate safety and efficacy of lansoprazole in preterm infants with gastroesophageal reflux documented by 24hr pH impedance monitoring


Eligibility criteria: Inclusion Criteria:

* preterm infant
* documented gastrointestinal reflux by 24hr pH monitoring

Exclusion Criteria:

* unstable vital sings
* congenital anomaly in upper gastrointestinal tract incuding esophagus
* drug history of H2 blocker during last 1 week
* medication of warfarin, carbamazepine, phenytoin, rifampin
* renal or hepatic dysfunction
* inappropriate clinical conditions judged by researchers

Primary outcomes:
measure: impedance pH monitoring
timeFrame: day14
Secondary outcomes:
measure: Symtomts of reflux_d5
timeFrame: day 5
measure: impedance pH monitoring_d10
timeFrame: day10
measure: impedance pH monitoring_d5
timeFrame: day5
measure: Symtomts of reflux_d10
timeFrame: day 10
measure: Symtomts of reflux_d14
timeFrame: Symtomts of reflux_d14 day 14
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Children's Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Han-Suk Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01757691: Fingolimod (FTY720) in Acute Demyelinating Optic Neuritis (ADON)
Official title: A 48-week, Double-blind, Randomized, Multi-center, Parallel-group Study Comparing Structural Changes in the Retina and Evolution of Visual Function After Immediate Versus Delayed Treatment With Fingolimod in Patients With Acute Demyelinating Optic Neuritis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Acute Demylelinating Optic Neuritis
Keywords: Acute demyelinating optic neuritis
Optic neuritis
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2012-12-31
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy and safety of fingolimod 0.5mg versus placebo in patients with suspected acute demyelinating optic neuritis (ADON) receiving standard steroid treatment


Eligibility criteria: Inclusion Criteria:

* Clinical signs and symptoms of ADON in one eye (loss of vision, pain on movement, impairment of color vision)
* First episode of ADON
* Able to undergo treatment with IV steroids

Exclusion Criteria:

* History of any unexplained eye or neurological symptoms lasting longer than 48 hours
* Optic neuritis in both eyes
* Concomitant condition in either eye, other than optic neuritis
* History of heart condition/disease
* Patients with uncontrolled diabetes mellitus
* Patients with liver conditions/disease
* Inability to undergo MRI
* Pregnant or nursing women
* Women of childbearing potential who are not using highly effective method of birth control

  * Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Mean Retinal Nerve Fiber Layer (RNFL) Thinning in Patients Treated With Fingolimod 0.5mg/Day, Relative to Patients Treated With Placebo
timeFrame: Baseline and Week 18
Secondary outcomes:
measure: Low Contrast Visual Acuity (LCVA)
timeFrame: Baseline, Week 48
measure: Vision Based Quality of Life (QoL) Utility Score
timeFrame: Baseline, Week 18, Week 48
measure: Proportion of Paatients Converting to Either 2005 or 2010 McDonald MS or to CDMS
timeFrame: Baseline, Week 18, Week 48
measure: Number of Particpants With Adverse Events as a Measure of Safety and Tolerability
timeFrame: Weeks 0, 4, 8, 12, 18, 24, 36, 48, 60
Other outcomes:
Locations:
city: St. Petersburg
country: United States
facility: Novartis Investigative Site
state: Florida
city: Majadahonda
country: Spain
facility: Novartis Investigative Site
state: Madrid
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT03382691: Accuracy of a Blood Pressure Measuring Mobile Device in Volunteers
Official title: M- HEALTHCARE Confirmatory Clinical Trials Used for Measurement of the ABP for the Accuracy and Safety Assessment of the Module Measuring Blood Pressure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Pressure
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Seoul National University Bundang Hospital
First posted: 2017-12-26
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The accuracy and safety of blood pressure module of new mobile device (M- HEALTHCARE device) is evaluated according to Korean FDA guidelines in 100 healthy volunteers.


Eligibility criteria: Inclusion Criteria:

1. Participants whose systolic blood pressure \<=110 should be at least 10% of whole cohort
2. Participants whose systolic blood pressure \>=160 should be at least 10% of whole cohort
3. Participants whose diastolic blood pressure \>=100 should be at least 10% of whole cohort
4. Participants whose diastolic blood pressure \<=70 should be at least 10% of whole cohort
5. Participants whose arm circumference are between 20cm and 30cm should be 25 - 50% of whole cohort
6. Participants whose arm circumference are between 30cm and 40cm should be 50 - 75% of whole cohort

Exclusion Criteria:

1. heart disease with abnormal rhythm
2. peripheral vascular anomaly or disease
3. inadequate to be applied blood pressure cuff (e.g. trauma on arm)
4. pregnant or lactating women

Primary outcomes:
measure: mean difference of systolic blood pressure
timeFrame: 1 day at visit 2
measure: mean difference of diastolic blood pressure
timeFrame: 1 day at visit 2
measure: standard deviation of the difference of systolic blood pressure
timeFrame: 1 day at visit 2
measure: standard deviation of the difference of diastolic blood pressure
timeFrame: 1 day at visit 2
Secondary outcomes:
Other outcomes:
Locations:
city: Seongnam Si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyenggi DO
Study officials:
References:
Clinical trial NCT02025491: Liposomal Amphotericin in Disseminated Leishmaniasis
Official title: Efficacy Study of Liposomal Amphotericin in Disseminated Leishmaniasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Disseminated Leishmaniasis
Keywords: Disseminated leishmaniasis
Liposomal Amphotericin B
Leishmania braziliensis
Lead sponsor: Hospital Universitário Professor Edgard Santos
Sponsor class: OTHER
First posted: 2014-01-01
Enrollment: 20
Sex: ALL
Minimum age (years): 14
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Disseminated leishmaniasis (DL) is an emerging and severe form of leishmaniasis, with increasing prevalence in Bahia, Brasil. It is characterized by multiple acneiform, papular and ulcerated lesions localized on the face, chest, abdomen and extremities. The number of lesions ranges from 10 to hundreds, and mucosal disease has been documented in more than 40% of the cases.

DL is a hard to cure disease and therapeutic failure with pentavalent antimony has been documented in up to 70% of the cases caused by L. braziliensis in the endemic area of Corte de Pedra, Bahia. The majority of DL patients need several courses of antimony or the use of high dose of Amphotericin B desoxicolate to cure. Therefore DL patients are exposed to relevant drug toxicity, high morbidity due to a long lasting disease, with an important socio-economic impact. Our hypothesis is that liposomal Amphotericin B has a higher cure rate than historic cure rates of pentavalent antimony in the treatment of disseminated leishmaniasis.


Eligibility criteria: Inclusion Criteria:

* a) clinical diagnosis of Disseminated Leishmaniasis according to case definition; b) illness duration of less than three months, c) parasite identification by culture or polymerase chain reaction methods, d) no previous treatment for leishmaniasis.

Exclusion Criteria:

* a) immunodeficiency or antibodies to HIV, b) pregnancy or patients not willing or unable to use contraceptives during and 3 months after the end of therapy c) ALT, AST ≥3x normal reference values, creatinine and BUN ≥1.5x normal reference values, d) any evidence of serious underlying disease (cardiac, renal, hepatic, or pulmonary) including serious infection other than DL.

Primary outcomes:
measure: Definitive cure
timeFrame: 3 months after treatment
Secondary outcomes:
measure: Toxicity
timeFrame: During the 7 to 15 days of treatment
Other outcomes:
Locations:
city: Salvador
country: Brazil
facility: HUPES
state: Bahia
Study officials:
affiliation: UFBA
name: Paulo RL Machado, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Machado PR, Rosa ME, Guimaraes LH, Prates FV, Queiroz A, Schriefer A, Carvalho EM. Treatment of Disseminated Leishmaniasis With Liposomal Amphotericin B. Clin Infect Dis. 2015 Sep 15;61(6):945-9. doi: 10.1093/cid/civ416. Epub 2015 Jun 5.
Clinical trial NCT03048591: The Exploratory Study of Electroacupuncture in the Treatment of Peripheral Neuropathy Induced by Platinum Based Chemotherapy Drugs
Official title: The Exploratory Study of Electroacupuncture in the Treatment of Peripheral Neuropathy Induced by Platinum Based Chemotherapy Drugs
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chemotherapy-induced Peripheral Neuropathy
Lead sponsor: Tianjin Medical University Cancer Institute and Hospital
Sponsor class: OTHER
First posted: 2017-02-09
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Through the research to confirm the effectiveness and safety of using electroacupuncture in the treatment of chemotherapy-induced peripheral neuropathy.


Eligibility criteria: Inclusion Criteria:

1. The histopathological and / or cellular pathology results prove malignancy of the tumor and the patient has received chemotherapy treatment before.
2. 15weeks after the completion of chemotherapy, the limbs are still feeling abnormal and the symptoms fulfill World Health Organization (WHO) grade 2 or more.
3. zubrod - Eastern Cooperative Oncology Group-WHO (ZPS) grade 0-2, cardiac function, liver function and renal function are not significantly abnormal, the survival period of the patient is expected to be more than 6 months.
4. Gender unrestricted, aged between 18 to 80 years old.
5. Voluntary participation in the study, will to sign informed consent, willing to comply with randomized grouping, will to follow-up.

Exclusion Criteria:

1. Patients who suffer from peripheral neuropathy due to infection, radiotherapy, HIV, chronic alcoholism, hypothyroidism, diabetes, paraneoplastic syndrome or other diseases; or are suffering from nervous system diseases.
2. Patients who are being treated with other drugs that may lead to neurotoxicity .
3. Patients with blood coagulation disorder.
4. Pregnancy and lactating women.
5. Patients with infection, scarring or defects near the acupoint sites.
6. Received intervention for the prevention and treatment of peripheral neuropathy 2 weeks before screening or has received traditional Chinese medicine (acupuncture, moxibustion, cupping, Chinese medicine therapy one month before.

Primary outcomes:
measure: Quality of life questionnaire to assess chemotherapy-induced peripheral neuropathy (QLQ-CIPN20)
timeFrame: 6 weeks
Secondary outcomes:
measure: Functional Assessment of Cancer Treatment - General scale（FACT-G）
timeFrame: 6 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Tianjin Medical University Cancer Institute and Hospital
name: Bin Wang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02219191: Puerarin Versus Atorvastatin in Treating Metabolism Syndrome in Patients With Chronic Rheumatic Diseases
Official title: The Effect of Puerarin Tablets in Treating Metabolism Syndrome in Patients With Chronic Rheumatic Diseases
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rheumatoid Arthritis
Keywords: Puerarin tablet
rheumatoid arthritis
metabolism syndrome
Lead sponsor: Chengdu PLA General Hospital
Sponsor class: OTHER
First posted: 2014-08-18
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the Effect of Puerarin tablets versus statins in treating metabolism syndrome in patients with chronic rheumatic diseases


Eligibility criteria: Inclusion Criteria:

* patients with a definite diagnose with rheumatic disease
* patients with metabolic Syndrome
* without conflict to the written, informed consent signed prior to the enrollment
* no severe hepatic or renal disorders
* no known carotid artery stenosis
* no coagulation disorders
* no hypertension

Exclusion Criteria:

* being in pregnancy, lactation period or under a pregnancy plan
* being allergic to the test drug
* not compatible for the trial medication
* without full legal capacity

Primary outcomes:
measure: Change from baseline in homeostasis model assessment (HOMA-IR)
timeFrame: At 0 week, 12 weeks, 24 weeks and 48 weeks
Secondary outcomes:
measure: Fasting serum low-density lipoprotein cholesterol (LDL-C)
timeFrame: at 0 week, 12 weeks, 24 weeks, 48 weeks
measure: Fasting serum high-density lipoprotein cholesterol (HDL-C)
timeFrame: at 0 week, 12 weeks, 24 weeks, 48 weeks
measure: erythrocyte sedimentation rate (ESR)
timeFrame: at 0 week, 12 weeks, 24 weeks, 48 weeks
measure: C reactive protein (CRP)
timeFrame: at 0 week, 12 weeks, 24 weeks, 48 weeks
measure: Fasting serum total cholesterol (TC)
timeFrame: at 0 week, 12 weeks, 24 weeks, 48 weeks
measure: Fasting serum triglycerides (TGs)
timeFrame: at 0 week, 12 weeks, 24 weeks, 48 weeks
measure: tumor necrosis factor (TNFα)
timeFrame: at 0 week, 12 weeks, 24 weeks, 48 weeks
measure: interleukin-8 (IL-8)
timeFrame: at 0 week, 12 weeks, 24 weeks, 48 weeks
measure: interleukin-1 (IL-1)
timeFrame: at 0 week, 12 weeks, 24 weeks, 48 weeks
measure: interleukin-6 (IL-6)
timeFrame: at 0 week, 12 weeks, 24 weeks, 48 weeks
measure: Fasting serum insulin
timeFrame: at 0 week, 12 weeks, 24 weeks, 48 weeks
measure: Fasting serum glucose
timeFrame: at 0 week, 12 weeks, 24 weeks, 48 weeks
measure: Kidney function
timeFrame: at 0 week, 12 weeks, 24 weeks, 48 weeks
measure: Liver function
timeFrame: at 0 week, 12 weeks, 24 weeks, 48 weeks
measure: blood cell count
timeFrame: at 0 week, 12 weeks, 24 weeks, 48 weeks
Other outcomes:
Locations:
city: Chengdu city
country: China
facility: 270 Rongdu street, Jin-niu district,Rheumatology Center of Integrated Medicine, General Hospital of Chengdu Military Area Command PLA，
state: Sichuan
Study officials:
References:
Clinical trial NCT03399591: Gait Disorders in Patients With Cognitive Decline
Official title: Correlation Between Gait Disorders and Neuropsychological Profile in Patients With Alzheimer's Disease and Lewy Body Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gait Disorders, Neurologic
Keywords: Gait Disorders
Spatio-temporal parameters of walking
Alzheimer's disease
Lewy body disease
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2018-01-16
Enrollment: 100
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient over the age of 50 with a gait disorder

Brief summary: The prevalence of neurodegenerative diseases will increase over the next decades driven by ageing population. It seems important to develop reliable, replicable and accessible diagnostic tools.

This is a prospective study whose objective is to study the spatio-temporal parameters of gait in patients with Alzheimer's and Lewy body diseases. 64 patients were included in this study. A comparison of the two pathologies was conducted, followed by an analysis based on four groups (mild, severe Alzheimer's disease, mild, severe Lewy body disease) and a study of the severity of the diseases. To study these parameters, we used the Gaitrite treadmill.

The analysis of spatio-temporal parameters of walking in Alzheimer's disease and Lewy body disease enables to identify discriminating variables between the two pathologies. The probability of suffering from an Alzheimer's disease decreases with the pace increase but increases with variations in length of the step, and with the rotation of the foot. While the probability of suffering from Lewy body disease increases with the pace, variations in the step duration, and the duration of double support.

These results are interesting but do not allow to establish a diagnostic score for these two diseases. The monitoring of the variations of these parameters at individual level would probably be more relevant and would enable to detect dual pathologies.


Eligibility criteria: Inclusion Criteria:

* Patient over 50
* Hospitalized patient in day hospital
* Patient with an etiological diagnosis of his cognitive disorder
* Patient having a neuropsychological assessment
* Patient able to walk without technical help
* Patient having agreed to participate in the study

Exclusion Criteria:

- Refusal to participate in the study

Primary outcomes:
measure: walking test
timeFrame: 1 hour after inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Gériatrie Hôpital de la Robertsau
Study officials:
affiliation: University Hospital, Strasbourg, France
name: Jérémie PERISSE, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00469391: Multi-Center Pre-Bariatric Weight Loss Study
Official title: A Multi-Center, Pilot Efficacy Study of the GI Sleeve for Pre-Surgical Weight Loss
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Obesity
Keywords: Weight Reduction
Lead sponsor: Morphic Medical Inc.
Sponsor class: INDUSTRY
First posted: 2007-05-04
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the safety and efficacy of the GI Sleeve in patients who require weight loss prior to their Bariatric surgery.

Detailed description: This is a randomized, patient blinded, prospective study.Patients will receive either a device or a sham procedure. Patients will be evaluated for the study and randomized to a treatment group if they qualify for the study. Throughout the study their weights will be obtained and various laboratory tests collected. A comparison of weight loss between the two groups will be assessed as the primary outcome measure.

Eligibility criteria: Inclusion Criteria:

* BMI \> 35 with a significant comorbid condition or BMI 40-60
* Candidate for Bariatric Surgery

Exclusion Criteria:

* No pathologies of the GI Tract
* No anti-coagulant or non-steroidal anti-inflammatory medications

Primary outcomes:
measure: Percent Excess Weight Loss (%EWL) at Week 12
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Weston
country: United States
facility: Cleveland Clinic Florida
state: Florida
city: Burlington
country: United States
facility: Lahey Clinic Medical Center
state: Massachusetts
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
Study officials:
affiliation: Tufts Medical Center
name: Michael Tarnoff, MD
role: STUDY_DIRECTOR
References: