louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00424957: Brain Energy Metabolism in Patients With Chronic Liver Disease and Impaired Central Nervous System
Official title: Brain Energy Metabolism in Patients With Acute Hepatic Encephalopathy Measured With PET
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cirrhosis
Hepatic Encephalopathy
Keywords: Ammonia
Astrocytes
Citric acid cycle
Alpha ketoglutarate dehydrogenase
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2007-01-22
Enrollment: 18
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 6 patients with liver cirrhosis with an acute episode of hepatic encephalopathy, 6 patients with liver cirrhosis without an acute episode of hepatic encephalopathy, 6 healthy subjects age and sex matched

Brief summary: The purpose of the current study is to look into the pathogenesis of a severe medical condition causing acute episodes on the central nervous system as seen in majority of patients with liver cirrhosis.


Eligibility criteria: Inclusion Criteria:

* 6 patients with liver cirrhosis with an acute episode of hepatic encephalopathy,
* 6 patients with liver cirrhosis without an acute episode of hepatic encephalopathy,
* 6 healthy subjects age and sex matched

Exclusion Criteria:

* Neurological and/or psychiatric condition,
* Non-treated diabetes,
* Pregnancy/breast-feeding

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: PET Centre, Aarhus University Hospital
Study officials:
affiliation: PET Centre and Medical department V, Aarhus Sygehus, Aarhus University Hospital
name: Susanne Keiding, MD
role: STUDY_CHAIR
References:
citation: Ott P, Clemmesen O, Larsen FS. Cerebral metabolic disturbances in the brain during acute liver failure: from hyperammonemia to energy failure and proteolysis. Neurochem Int. 2005 Jul;47(1-2):13-8. doi: 10.1016/j.neuint.2005.04.002.
Clinical trial NCT06585657: Brain Visual Perception Training for Prevention and Control of Premyopia
Official title: Clinical Study on Brain Visual Perception Training for Prevention and Control of Myopia in Children with Premyopia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Visual Function
Myopia Progressing
Keywords: brain visual perception training
premyopia
Lead sponsor: Shanghai Eye Disease Prevention and Treatment Center
Sponsor class: OTHER
First posted: 2024-09-05
Enrollment: 156
Sex: ALL
Minimum age (years): 6
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this clinical trial is to investigate whether brain visual perception training can effectively prevent myopia in children with pre myopia. It will also learn about the safety of brain visual perception training.

The main questions it aims to answer are: Does brain visual perception training slow down the growth of axial length? What medical issues may participants encounter when using the brain visual perception training system? Researchers will compare participants who receive brain visual perception training with a control group to see if the training group can delay the onset of pre myopia in children Participants will: The training group will receive 20 minutes of brain visual perception training once a day for a period of one year. Follow up check ups at the hospital every 3 months. Keep a diary of the values of axial length and refractive diopter.


Eligibility criteria: Inclusion Criteria:

Children aged 6-10 years with premyopia, defined as a cycloplegic spherical equivalent refraction (SER) of the more myopic eye in the range of -0.50 to 0.75 (inclusive) diopters (D) and having at least 1parent with an SER in either eye of -3.00D or less.

Exclusion Criteria:

Children have astigmatism of 1.50D or more, anisometropia of 1.50 D or more, strabismus and other ocular abnormalities, any systemic diseases, or a history of any myopia interventions.

Primary outcomes:
measure: changes in axial length after 1 year
timeFrame: 1 year after the baseline
Secondary outcomes:
measure: changes in cycloplegic spherical equivalent after 1year
timeFrame: 1 year after the baseline
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06329557: Optimizing the Patient Experience Through Provider Coaching or Communication Intervention
Official title: Optimizing the Patient Experience Through Provider Coaching or Communication Intervention
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Patient Satisfaction
Communication
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2024-03-26
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Hypothesis: Clinicians who receive patient experience coaching or communication classes have improved patient satisfaction scores and improved clinician satisfaction.

Detailed description: Aims, purpose, or objectives:

To identify if patient experience coaching or communication classes have an effect on patient satisfaction scores and clinician satisfaction.

Eligibility criteria: Inclusion Criteria:

• Clinicians of Primary Care Mayo Clinic

Exclusion Criteria:

* Not clinicians of Primary Care Mayo Clinic or Residents within Rochester Primary Care Clinicians from Family Medicine, or Clinicians from Community Internal Medicine Geriatrics, Palliative Medicine, and Community Pediatrics and Adolescent Medicine

Primary outcomes:
measure: To identify if patient experience coaching or communication classes have an effect on patient satisfaction scores and clinician satisfaction.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Summer V Allen
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01280357: Accuracy and Reliability of Fetal Heart Rate and Uterine Contraction Monitoring Method
Official title: Study to Determine Substantial Equivalence of Electrohysterography (EHG) Monitoring to Tocodynanometer Monitoring
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy; Habitual Aborter
Weeks of Gestation 37 or More
Keywords: Fetal Heart Rate (FHR)
Uterine Activity (UA)
Labor & Delivery
Lead sponsor: Monica Healthcare Ltd
Sponsor class: INDUSTRY
First posted: 2011-01-20
Enrollment: 60
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Clinical Investigation Protocol for a study designed to determine the equivalence of the Monica AN24 monitor to Philips 50XM for fetal heart rate (FHR) and uterine contraction (UC) monitoring during labor. The study will be carried out on subjects in the first and second stages of labor.

Detailed description: The study is a prospective, randomized, single-center observational study designed to compare the Fetal Heart Rate (FHR) and Uterine Activity (UA) output data obtained by the Monica AN24 monitor during the first and second stages of labor to those generated by existing FDA-approved devices.Patients were enrolled at the facility but the patient details were removed from the results in order that the data could be randomized for the statistical analysis.

Eligibility criteria: Inclusion Criteria:

* Pregnant, age 15-40
* Term gestation (\>36 completed weeks)
* Singleton fetus
* Active labor
* Vertex presentation
* Requiring internal monitoring

Exclusion Criteria:

* Clinical contraindication for Intra Uterine Pressure Catheter
* Major fetal malformation

Primary outcomes:
measure: The Mean Positive Percentage Agreement (PPA) for Fetal Heart Between Device 1 Monica AN24 & Device 2 Philips 50XM
timeFrame: during labor and delivery the waveforms were measured for between 35 minutes and 15 hours during the first and second stage of labour
measure: The Mean Positive Percentage Agreement (PPA) for Maternal Heart Between Device 1 Monica AN24 & Device 2 Philips 50XM
timeFrame: during labor and delivery the waveforms were measured for between 35 minutes and 15 hours during the first and second stage of labour
Secondary outcomes:
measure: The Mean Positive Percentage Agreement for Uterine Contractions Between the Monica AN24 & The Philips 50XM
timeFrame: between 35 mins & 15hrs during first & second stage labor
Other outcomes:
Locations:
city: New York
country: United States
facility: Queens Hospital Center
state: New York
city: Philadelphia
country: United States
facility: Temple University
state: Pennsylvania
Study officials:
affiliation: Queens Hospital Centre
name: Wayne Cohen, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04087057: Barriers Associated With Timely Adjuvant Chemotherapy Administration in Patients With Invasive Breast Cancer
Official title: Understanding Barriers Associated With Timely Chemotherapy Administration Among Breast Cancer Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Invasive Breast Carcinoma
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-09-12
Enrollment: 24
Sex: FEMALE
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 with invasive breast cancer

Brief summary: This trial studies the barriers associated with timely chemotherapy given after surgery (adjuvant) in patients with invasive breast cancer. Meeting with patients and asking questions may help doctors to learn about factors that can cause delays in the start of chemotherapy after surgery in patients with breast cancer.

Detailed description: PRIMARY OBJECTIVES:

I. To comprehensively and qualitatively assess and identify the determinants of time to chemotherapy (TTC) delays in a vulnerable population using qualitative methods.

Ia. To describe the health literacy/numeracy, social support and level of trust in physicians of the study participants. (Exploratory)

OUTLINE:

Patients complete questionnaires and participate in an interview to answer questions about the information patients received before starting the chemotherapy, any medical problems after the surgery that could have been related to the start of the chemotherapy, how the chemotherapy affected patients' life, and anything else patients may remember between the time when the breast surgery ended and the first dose of chemotherapy started. Patients' medical records are also reviewed.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with primary invasive breast cancer
* For patients receiving adjuvant chemotherapy: First dose of chemotherapy administered \>= 60 days after definitive breast cancer surgery. For patient treated with neoadjuvant chemotherapy: First dose of chemotherapy administered \>= 60 days after pathological diagnosis
* Diagnosis of breast cancer within three years of study enrollment
* Can speak, read, and understand English and/or Spanish
* Patient of Lyndon B. Johnson General Hospital-Harris Health System (LBJ-HHS) or MD Anderson Cancer Center

Exclusion Criteria:

* Women hospitalized for a critical condition or who are considered medically unstable by their medical team
* Patients that started chemotherapy \>= 3 years after definitive breast cancer surgery

Primary outcomes:
measure: Assessment of data collected from individual semi-structured interviews
timeFrame: Up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Mariana Chavez Mac Gregor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06376357: The Effect of Foot Massage With Roles on Cancer Patients
Official title: Roles in the Management of Treatment-Induced Peripheral Neuropathy in Cancer Patients Receiving Taxane-Based Chemotherapy and the Effect of Foot Massage on Neuropathy and Quality of Life: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Breast Neoplasms
Over Cancer
Foot Massage
Lead sponsor: Selcuk University
Sponsor class: OTHER
First posted: 2024-04-19
Enrollment: 54
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: It was aimed to examine the roles in the management of treatment-related peripheral neuropathy in cancer patients receiving taxane-based chemotherapy and the effect of foot massage on neuropathy and quality of life.

Detailed description: Intervention Phase of the Research;

1. Patient information about neuropathy caused by chemotherapy and its management,
2. Teaching the role application to the patient,
3. Application process
4. It will be carried out in 4 steps, including patient monitoring via telemonitoring.

Eligibility criteria: Inclusion Criteria:

* Being registered in the medical oncology outpatient clinic of Selçuk University Faculty of Medicine Hospital
* Completed standard taxane-based chemotherapy treatment protocol for breast and ovarian cancer
* Karnofsky Performance Scale being 80 and above (Performance scale of cancer patients)
* Being 18 years or older
* Having received at least 3 cycles of taxane-based treatment
* Presence of grade 2 or higher peripheral neuropathy
* Being conscious and cooperative
* Verbal and written approval to participate in the study after an explanation about the study is made.

Exclusion Criteria:

* Previous skin sensitivity on hands and feet
* Refused to participate in the study after making a statement about the study
* Development of peripheral neuropathy due to reasons other than chemotherapy \[tumor compression, nutritional disorders, infections or major systemic disease (diabetes mellitus, etc.)\]
* Bone, spine metastasis or malignancy
* Having mental and psychic problems that would prevent him from taking part in the research.

Primary outcomes:
measure: EORTC QLQ C-30 Quality of Life Scale
timeFrame: 10 minutes
measure: CIPN20 Neuropathy Scale
timeFrame: 10 minutes
measure: One Leg Standing Test
timeFrame: 5 minutes
measure: Brief Pain Inventory BPI
timeFrame: 5 minutes
measure: Pain Threshold Assessment Test
timeFrame: 5 minutes
measure: Two Point Discrimination
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Selçuklu
country: Turkey
facility: ülkü Saygili Düzova
state: Konya
Study officials:
References:
Clinical trial NCT01689857: Clinical Trial to Evaluate the Safety and Efficacy of Scarclinic™ Thin in Surgical Scars
Official title: Phase 4 Study of Scarclinic™ Thin That Treats Surgical Scars.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertrophic Surgical Scar
Keywords: hypertropic scar, Vancouver scar scale, silicon gel sheet
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2012-09-21
Enrollment: 40
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: Compare the efficacy and safety of Scarclinic™Thin and Scarclinic™ Normal for the treatment of surgical scars.

Participant: 40 Treatment period : 3 months Medical device: Scarclinic™Thin , Scarclinic™ Normal Randomization: Table of random number

Detailed description: For evaluating the efficacy

* The investigator check Vancouver Scar Scale at 1 and 3 month after application to evaluate vascularity, pigmentation, elasticity, height, pain and itchiness
* The participant filled out survey included questions regarding convenience in use at 1 and 3 month after application.

Eligibility criteria: Inclusion Criteria:

* Patient who aged more than 18 years and less 55 years
* Patient who has a surgical scar that is not over 3 months after the surgery
* Patient who sign informed consent form for the study

Exclusion Criteria:

* need wound dressing for exudate
* wound infection
* general malaise
* history of mental disorders
* taking anticancer drugs or antiphlogistics or steroid

Primary outcomes:
measure: Change From Baseline in Vancouver Scar Scale Score(VSS) at 3 Months
timeFrame: Baseline and 3 months
Secondary outcomes:
measure: Satisfaction for Serviceability
timeFrame: the end of the 3 month of the treatment
Other outcomes:
Locations:
city: Bundang-gu
country: Korea, Republic of
facility: Seoul National Univ. Bundang Hospital
state: Seongnam-si,Gyeonggi-do
Study officials:
affiliation: Seoul National University Hospital
name: ChanYoung Heo, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01017757: Interstitial Lung Abnormalities in Renal Transplant Recipients
Official title: Cross-sectional Analysis of Subclinical Interstitial Lung Abnormalities in Stable Renal Transplant Recipients by High-resolution CT Scan
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Renal Transplantation
Kidney-pancreas Transplantation
Keywords: Interstitial lung disease
Immunosuppressive therapy
Renal transplant
Lead sponsor: University of Parma
Sponsor class: OTHER
First posted: 2009-11-23
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 82
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Kidney or kidney-pancreas recipients, on immunosuppressive therapy for at least 24 months

Brief summary: Immunosuppressive drugs such as tacrolimus, cyclosporine, mycophenolate mofetil, sirolimus and everolimus may have toxic pulmonary effects, particularly interstitial alterations. The aim of the present study is to explore the presence of subclinical interstitial lung abnormalities in stable renal transplant recipients taking the different immunosuppressive drugs used as maintenance therapy for renal transplantation.

Detailed description: Prospective, cross-sectional study examining the high-resolution CT scans obtained in 63 stable renal transplant recipients taking immunosuppressive treatment for at least 24 months. The findings in patients taking the newer immunosuppressive drugs (mycophenolic acid, sirolimus and everolimus) are compared with those of the patients treated in the traditional way (cyclosporine, tacrolimus, azathioprine). All patients undergo high-resolution CT scanning.

Eligibility criteria: recipients of kidney or kidney-pancreas transplant, on immunosuppressive therapy for at least 24 months, with stable renal function and absence of any overt lung disease or lung alterations induced by other drugs, systemic diseases or occupational exposure to fibrogenic agents.

Eligibility criteria: Inclusion Criteria:

* Renal transplant patients with stable renal function taking immunosuppressive therapy for at least 24 months and providing written informed consent to participate to the study

Exclusion Criteria:

* Overt lung disorders, lung toxicity due to other drugs or occupational exposure to lung-toxic agents
* Systemic connective tissue disorders or systemic vasculitis

Primary outcomes:
measure: Subclinical lung alterations as assessed by high-resolution CT scanning
timeFrame: CT is performed at study entry and, if abnormalities are found, it is repeated at 3-6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Parma
country: Italy
facility: Department of Clinical Medicine Nephrology and Health Science, Parma University Hospital
Study officials:
affiliation: University of Parma
name: Carlo Buzio, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03125057: A Pilot Study of Hemoporfin PDT in Children With Port-wine Stain
Official title: A Pilot Study of Hemoporfin Photodynamic Therapy in Children (7-14 Years Old) With Port-wine Stain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Port-wine Stain
Lead sponsor: Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2017-04-24
Enrollment: 24
Sex: ALL
Minimum age (years): 7
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This pilot study aims to evaluate the efficacy and safety of hemoporfin photodynamic therapy (PDT) with different light doses for port-wine stain (PWS） in 7-14 years old children. The population pharmacokinetics of hemoporfin in children will be investigated as well.


Eligibility criteria: Inclusion Criteria:

* Children with clinical diagnosis of PWS；
* Age range: 7 to 14 years-old；
* Voluntarily participated and Written informed consent signed

Exclusion Criteria:

* Therapy area located outside of head and neck;
* Other skin diseases that might interfere with the efficacy evaluation;
* Therapy area was previously received isotope or PDT or other treatment which might interfere with the efficacy evaluation;
* Allergy to porphyrins and analogues; Photosensitivity; Porphyria; Allergic constitution;
* Scar diathesis;
* Immunocompromised conditions;
* Electrocardiographic abnormalities or organic heart diseases;
* Coagulation disorders;
* Hepatic or renal functions abnormal (alanine aminotransferase or aspartate transaminase or total bilirubin \> 1.5 upper limit of normal \[ULN\], or serum creatinine or blood urea nitrogen \> 1.5 ULN);
* Psychiatric diseases; Severe endocrinopathies;
* Previous therapy of PWS within the last 4 weeks;
* Participation in any clinical studies within the last 4 weeks;
* Be judged not suitable to participate the study by the investigators

Primary outcomes:
measure: Response rate
timeFrame: week 8
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Children's Hospital, Capital Medical University
Study officials:
affiliation: Bejing Children's Hospital, Capital Medical University
name: Lin Ma, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
name: Jining Tao
role: STUDY_DIRECTOR
References: