louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04128150: High Resolution Retina Imaging
Official title: High Resolution Retina Imaging
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Retinitis Pigmentosa
Maculopathy, Age Related
Macular Dystrophy
Macular Edema
Retinal Degeneration
Diabetic Retinopathy
Occlusion Retinal Vein
Hypertension
Lead sponsor: Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
Sponsor class: OTHER
First posted: 2019-10-16
Enrollment: 1000
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with pathologies affecting photoreceptors and the retinal vessels

Brief summary: To increase the clinical experience of using the rtx1 camera in various retinal disorders and to follow the evolution of structural alterations during retinal diseases using adaptive optics imaging with the rtx1 camera


Eligibility criteria: Inclusion Criteria:

* Persons over 12 years of age, of both sexes, presenting with retinal pathologies.
* Beneficiaries of the health insurance

Exclusion Criteria:

* Any abnormality preventing good quality OA imaging on both eyes
* Major under guardianship or curatorship

Primary outcomes:
measure: Evolution of retina diseases
timeFrame: From date of inclusion until the date of last documented progression , assessed up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Lariboisière
city: Paris
country: France
facility: Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
city: Paris
country: France
facility: Hôpital Pitié-Salpétrière
Study officials:
affiliation: Centre Hospitalier National d'Ophtalmologie des Quinze-Vints
name: Michel PAQUES
role: PRINCIPAL_INVESTIGATOR
References:
citation: Paques M, Norberg N, Chaumette C, Sennlaub F, Rossi E, Borella Y, Grieve K. Long Term Time-Lapse Imaging of Geographic Atrophy: A Pilot Study. Front Med (Lausanne). 2022 Jun 22;9:868163. doi: 10.3389/fmed.2022.868163. eCollection 2022.
Clinical trial NCT03978650: Risk Factors for Falls and Fall-related Injuries Associated With Mild Neurocognitive Disorders
Official title: Risk Factors for Falls and Fall-related Injuries Associated With Mild Neurocognitive Disorders in the Older Canadian Population: A Population-based, Prospective, Longitudinal, Observational Cohort Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Old Age
Fall Injury
Neurocognitive Disorders
Lead sponsor: Jewish General Hospital
Sponsor class: OTHER
First posted: 2019-06-07
Enrollment: 12000
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * People from Canada who are 65 years and over.
* Men and women who were enrolled into the Canadian Longitudinal Study on Aging
* Participants who attended the face-to-face interview questionnaires about diet, medication use, chronic disease symptoms, and sleep disorders.

Brief summary: This study evaluates the risk for incident falls and fall-related injuries at the onset of neurocognitive disorders in older adults participating in the Canadian Longitudinal Study

Detailed description: Falls are frequent events in adults over age 65 (up to 30% each year in Canada). They are a major Canadian public health concern, which negatively impacts health and quality of life of fallers, and health care system. Neurocognitive disorders are strongly associated with falls and fall-related injuries.

Several clinical characteristics, identified previously as risk factors for falls in the older population and in older adults with neurocognitive disorders are selected in the Canadian Longitudinal Study On Aging. The performance criteria of different statistical models will be compared for the association of neurocognitive disorders with falls and fall-related injuries. Six linear statistical models (i.e., logistic regression, discriminant analysis, Bayes network algorithm, decision tree, random forest, boosted trees), Factor Mixture Models and two different artificial neural network (i.e., multilayer perceptron and the neuroevolution of augmenting topologies).

Eligibility criteria: Inclusion Criteria:

* People who are 65 years and over
* Men and women who live in Canada

Exclusion Criteria:

* People who do not live in Canada
* A fall resulting from acute medical event and/or an external factor
* Moderate to severe dementia

Primary outcomes:
measure: Fall Injury
timeFrame: 18 months
Secondary outcomes:
measure: Auditory verbal memory disorder
timeFrame: around 20 years
measure: The Mental Alteration Test
timeFrame: around 20 years
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Jewish General Hospital
state: Quebec
Study officials:
affiliation: Jewish General Hospital
name: Olivier Beauchet, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02504450: Outcomes of Antipsychotic Medication Used in the Emergency Department
Official title: Outcomes of Antipsychotic Medication Use in the Emergency Department: A Retrospective Comparison Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Agitation,Psychomotor
Keywords: Bipolar 1 disorder
schizophrenia
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2015-07-22
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: subjects treated in the emergency department for agitation

Brief summary: To review records of patients treated with antipsychotics (including Adasuve, Geodon, Haldol) in order to evaluate outcomes.

Detailed description: A retrospective chart review will be performed for all patients presenting to the ED with agitation and subsequently given antipsychotic therapy for treatment. Identification of patients will be through chart review of patients presenting with agitation. Data to be recorded include patient age, gender, medical history, time of presentation, time of treatment, co morbidities, use of restraint, time to disposition and patient outcome. Inclusion criteria include all patients over age 18 presenting to the ED with agitation and treated with antipsychotics. No patients will be knowingly excluded from analysis. We will compare resulting outcomes of patients treated for agitation to see if Adasuve is superior to other commonly prescribed antipsychotics through its rate of discharge home and overall time in the emergency department.

Eligibility criteria: Inclusion Criteria:

* All patients given antipsychotic therapy for acute agitation

Exclusion Criteria:

* None

Primary outcomes:
measure: Length of stay in the emergency department
timeFrame: Participants will be followed for the duration of emergency department stay, an expected average of 12 hours.
Secondary outcomes:
measure: Disposition
timeFrame: Participants will be followed for the duration of emergency department stay, an expected average of 12 hours.
Other outcomes:
Locations:
Study officials:
affiliation: Advocate Healthcare
name: Erik Kulstad, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dinh KV, Myers DJ, Noymer PD, Cassella JV. In vitro aerosol deposition in the oropharyngeal region for Staccato loxapine. J Aerosol Med Pulm Drug Deliv. 2010 Aug;23(4):253-60. doi: 10.1089/jamp.2009.0814.
citation: Valdes J, Shipley T, Rey JA. Loxapine inhalation powder (adasuve): a new and innovative formulation of an antipsychotic treatment for agitation. P T. 2014 Sep;39(9):621-3, 648.
Clinical trial NCT03426150: Casein Phosphopeptide--amorphous Calcium Phosphate on Human Enamel Subjected to in Vivo Acid Attacks
Official title: In Situ Effect of Casein Phosphopeptide--amorphous Calcium Phosphate on the Surface Microhardness of Human Enamel Subjected to in Vivo Acid Attacks
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dental Erosion
Lead sponsor: Fujian Medical University
Sponsor class: OTHER
First posted: 2018-02-08
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: 40 specimens were prepared from fresh-extracted human molars and further embedded using the acrylic resin. Specimens were randomly divided into 2 groups according to the treatment before in vivo erosion (n=20): CPP-ACP for 3 min (CPP-ACP group) and deionized water for 3 min (control group). 10 healthy volunteers were recruited and customized maxillary appliance containing 4 specimens (2 from CPP-ACP group and 2 from control group) was fabricated for each volunteer. Participants were instructed to drink 150 ml cola in 5 min using the gargling method after placing appliances intraorally for 2 h. The in vivo attacks were performed 4 X 5 min with 1-h interval daily over 7 d. The surface microhardness and surface microstructure of the specimens were evaluated at the baseline and after the treatment. The data were statistically analyzed using three-way ANOVA and post hoc tests. Data were considered statistically significant at a level of P \<0.05.


Eligibility criteria: Inclusion Criteria:

* 18 to 60 years of age and in good general health
* Dental erosion and wear degree is 0-1

Exclusion Criteria:

* Systemic diseases or oral mucosal disorders
* Current orthodontic treatment
* Pregnancy
* Known allergies to the experimental drink
* Had been given drugs which lead to dry oral more regularly within half a year

Primary outcomes:
measure: Surface microhardness
timeFrame: baseline
measure: Surface microhardness
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: School and Hospital of Stomatology, Fujian Medical University
name: Hao Yu, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yu H, Jiang NW, Ye XY, Zheng HY, Attin T, Cheng H. In situ effect of Tooth Mousse containing CPP-ACP on human enamel subjected to in vivo acid attacks. J Dent. 2018 Sep;76:40-45. doi: 10.1016/j.jdent.2018.05.021. Epub 2018 May 30.
Clinical trial NCT02094950: Acupuncture Feasibility Trial for Dyspnea in Lung Cancer
Official title: Acupuncture Feasibility Trial for Dyspnea in Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Lung Cancer
Dyspnea
Keywords: concurrent chemotherapy
concurrent radiation
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2014-03-24
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a single arm clinical trial to establish the feasibility of conducting a clinical trial of acupuncture in reducing dyspnea among lung cancer survivors who have completed chemoradiotherapy. Twelve subjects with dyspnea will be recruited to this clinical trial. Up to 10 sessions of acupuncture will be delivered over the course of 8-10 weeks. The primary outcome will be dyspnea as measured by the English version of the Cancer Dyspnea Scale at the completion of the intervention.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Lung Cancer (Non small cell and small cell both eligible)
* Completion of concurrent CRT at least 6 months prior to randomization.
* Dyspnea which worsened after Chemoradiotherapy, leading to a ATS dyspnea score greater than or equal to 2 (Walks slower than people of the same age on the level because of breathlessness or has to stop for breath when walking at own pace on level)
* Ability to understand written English -Willingness to adhere to all study-related procedures
* Age 18 years old
* ECOG Performance Status 1-3

Exclusion Criteria:

* Current receipt of therapy for treatment related pneumonitis for 3 weeks.
* Surgical resection of this LC (lobectomy or pneumonectomy)
* Another organic cause of dyspnea necessitating treatment (eg pleural effusion appropriate for thoracentesis, rapidly progressive intrathoracic recurrence, symptomatic pulmonary embolus after CRT, untreated anemia with hemoglobin8 g/dL)
* Current bleeding disorder by history
* Life expectancy of 12 weeks, as assessed by primary oncologist

Primary outcomes:
measure: Dyspnea
timeFrame: 10 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Abramson Cancer Center at Penn Medicine
name: Joshua Bauml, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04992650: Ultrasonic Perfusion Imaging in Post-mastectomy Irradiated Patients
Official title: Ultrasonic Perfusion Imaging for Monitoring Mastectomy Skin Microcirculation in Post-mastectomy Irradiated Patients Before and After Autologous Fat Transfer
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Breast Reconstruction
Radiation Dermatitis
Radiation Fibrosis
Fat Grafting
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2021-08-05
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to evaluate post-mastectomy breast skin blood supply (perfusion) after radiation therapy, and before and after fat grafting to the breast(s).


Eligibility criteria: Inclusion Criteria:

* Breast cancer patients undergoing immediate tissue expander or implant reconstruction requiring radiation therapy
* Have undergone mastectomy

Exclusion Criteria:

* Patients who are unwilling to participate

Primary outcomes:
measure: Radiation Fibrosis
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Christin A. Harless, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05763550: To Evaluate the Efficacy and Safety of HSK16149 Capsule in Chinese Patients With Herpetic Neuralgia
Official title: A Multicenter, Randomized, Double-Blind, Double-Dummy , Pregaballin-Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of HSK16149 Capsules in Chinese Patients With Herpetic Neuralgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Herpetic Neuralgia
Lead sponsor: Haisco Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-03-10
Enrollment: 331
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Investigate the efficacy and safety of HSK16149 capsules in Chinese herpetic Neuralgia following 4 weeks treatment in comparison to pregabalin.


Eligibility criteria: Inclusion Criteria:

* Signed informed consent;
* Males or females aged 18 years and older ;
* Patients must have herpetic neuralgia;
* At Screening, pain scale (VAS) of ≥ 40 mm;
* At Screening, pain scale (NRS) of ≥ 4.

Exclusion Criteria:

* Patients have pain present for more than 1 months after the healing of the herpes zoster skin rash;
* AST/ALT \> 2 × upper limit of normal (ULN), or TBIL≥1.5 × ULN;
* Serum Creatine \> 176μmol/L;
* Any active infections at screening;
* History of allergic or medically significant adverse reaction to investigational products or their excipients, pregabalin or related compounds;
* Participated in another clinical study within 30 days prior to screening;
* Pregnant or breastfeeding at screening ;
* Other conditions unlikely to participate in this trial.

Primary outcomes:
measure: Compare the change from baseline in Numeric Rating Scales(NRS )between HSK16149 and pregabalin at week 4
timeFrame: Baseline and week 4
Secondary outcomes:
measure: Compare the response rate between HSK16149 and pregabalin at week 4 (Proportion of subjects whose NRS decreased by ≥30% and≥ 50% from baseline )
timeFrame: Baseline and week 4
measure: Compare the change from baseline in VAS between HSK16149 and pregabalin at week 4
timeFrame: Baseline and week 4
measure: Compare the change from baseline in DSIS between HSK16149 and pregabalin at week 4
timeFrame: Baseline and week 4
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
affiliation: Haisco
name: Fangqiong Li
role: STUDY_CHAIR
References:
Clinical trial NCT06609850: The Comparison of TACE-Lenvatinib With TACE-Lenvatinib-ablation for Intermediate Recurrent Hepatocellular Carcinoma
Official title: The Comparison of TACE-Lenvatinib With TACE-Lenvatinib-ablation for Intermediate Recurrent Hepatocellular Carcinoma: a Multicenter Randomized Control Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Recurrent Hepatocellular Carcinoma
Lenvatinib
Local Therapy
Ablation
Systemic Therapy
Keywords: Lenvatinb
Hepatocellular carcinoma
Microwave ablation
Radiofrequency ablation
Cryoablation
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Chinese PLA General Hospital
First posted: 2024-09-24
Enrollment: 116
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: Studies have shown that combination therapy of TACE with Lenvatinib could achieve better survival outcomes than TACE alone for hepatocellular carcinoma (HCC) at BCLC B stage. However, whether patients could benefit from the ablation for intermediate recurrent HCC (RHCC) is still need high quality clinical evidence. This study is to evaluate the efficacy of ablation combined with TACE and Lenvatinib for the intermediate-stage RHCC.

Detailed description: The evidence of ablation combined transarterial chemoembolisation (TACE) and Lenvatinib for intermediate-stage recurrent hepatocellular carcinoma (RHCC) is limited. Patient responses to this treatment vary because of the heterogeneous nature of RHCC. Thus, it is important to identify patients who are most likely to benefit from this three regimes therapy. The aim of this study is to comparison of TACE-Lenvatinib with TACE-Lenvatinib-ablation for intermediate RHCC.

Eligibility criteria: Inclusion Criteria:

1. 18-75 years;
2. RHCC diagnosed by imaging;
3. intermediate-stage RHCC (two to three lesions which at least one was \>3 cm in size or more than three tumors);
4. the tumor number was no more than six, and the maximum tumor diameter was ≤5 cm;
5. absence of extrahepatic metastasis or macrovascular invasion;
6. Child-Pugh class A or B;
7. TACE as initial treatment after tumor recurrence and showed no tumor progression after TACE.
8. life expectance \>3 months;

Exclusion Criteria:

1. under 18 years or over 75 years of age;
2. primary intermediate-stage HCC;
3. RHCC with more than six tumors, or single RHCC

(5) RHCC \>5cm; (6) extrahepatic metastasis; (7) macrovascular tumor thrombus;

Primary outcomes:
measure: Progression free survival (PFS)
timeFrame: 24 months
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: 36 month
measure: Objective response rate (ORR)
timeFrame: 12 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General hospital
state: None Selected
Study officials:
affiliation: Chinese PLA General Hospital
name: Feng Duan
role: STUDY_DIRECTOR
References:
Clinical trial NCT00389350: Effect of an Extract of Green Tea on Adults With Type 2 Diabetes
Official title: The Effect of an Extract of Green Tea on Glucose Control in Adults With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Diabetes
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
First posted: 2006-10-18
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study was to determine if taking an extract of green tea for three months could improve glucose control in adults with diabetes.

Detailed description: Background: Recent evidence suggests that tea from Camellia Senensis (e.g., green, oolong and black tea) may have a hypoglycemic effect.

Objective: We evaluated the ability of an extract of green and black tea to improve glucose control over a three month period using a double blinded randomized multiple dose (either placebo, 375mg or 750mg) study in adults in with Type 2 Diabetes.

Patients: The 49 subjects who completed this study were predominantly whites with an average age of 65, a median duration of Diabetes of 6 years, and 80% reported using hypoglycemic medication.

Measurements: HbA1c at three months was the primary endpoint. Results: After three months the mean changes in HbA1c were +0.4, +0.3 and +0.5, in the placebo, 375mg and 750mg arms, respectively. The changes were not significantly different between study arms.

Limitations: Evaluation of a particular extract that contained components of black teas as well as green tea. Power insufficient to detect changes in HbA1c \< 0.5.

Conclusions: We did not find a hypoglycemic effect of extract of green tea in adults with Type 2 Diabetes, but cannot rule out the possibility that tea may have a small beneficial effect.

Eligibility criteria: Inclusion Criteria:

* Adults with Diabetes not taking insulin

Exclusion Criteria:

* pregnancy, warfarin therapy

Primary outcomes:
measure: HbA1c
Secondary outcomes:
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: Todd A MacKenzie, PhD
role: PRINCIPAL_INVESTIGATOR
References: