louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05948345: Evaluating Factors In Study Experiences of Lymphedema Patients
Official title: Exploring the Real-life Stories of Individuals Enrolled in Lymphedema Clinical Trials
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Lymphedema
Keywords: Lymphedema
Lead sponsor: Power Life Sciences Inc.
Sponsor class: INDUSTRY
First posted: 2023-07-17
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with lymphedema who are actively considering enrolling in an interventional clinical trial for said condition, but have not yet completed enrollment and randomization phases in said clinical trial.

Brief summary: The study intends to investigate the personal experiences of lymphedema patients who take part in a separate clinical trial including a specific medication intervention. The major focus will be on closely following individuals' rates of trial completion and withdrawal.

The data collected from this study will help improve future outcomes for all lymphedema patients as well as those in under-represented demographic groups.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with lymphedema
* Aged ≥ 18 years old and ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed
* Subjects willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examination.

Exclusion Criteria:

* Refusal of consent
* Women of childbearing potential without a negative pregnancy test; or women who are lactating.
* Any serious and/or unstable pre-existing medical disorders

Primary outcomes:
measure: Number of patients who decide to enroll in a lymphedema clinical trial
timeFrame: 3 months
measure: Rate of patients who remain in lymphedema clinical trial to trial completion
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Power Life Sciences
state: California
Study officials:
affiliation: Power Life Sciences Inc.
name: Michael B Gill
role: STUDY_DIRECTOR
References:
citation: Quere I, Presles E, Coupe M, Vignes S, Vaillant L, Eveno D, Laporte S, Leizorovicz A; POLIT Study investigators. Prospective multicentre observational study of lymphedema therapy: POLIT study. J Mal Vasc. 2014 Jul;39(4):256-63. doi: 10.1016/j.jmv.2014.05.004. Epub 2014 Jun 12.
citation: Boccardo F, Santori G, Villa G, Accogli S, Dessalvi S. Long-term patency of multiple lymphatic-venous anastomoses in cancer-related lymphedema: A single center observational study. Microsurgery. 2022 Oct;42(7):668-676. doi: 10.1002/micr.30944. Epub 2022 Aug 2.
citation: Johansson K, Blom K, Nilsson-Wikmar L, Brogardh C. Early Intervention with a Compression Sleeve in Mild Breast Cancer-Related Arm Lymphedema: A 12-Month Prospective Observational Study. Cancers (Basel). 2023 May 9;15(10):2674. doi: 10.3390/cancers15102674.
Clinical trial NCT00002845: Interleukin-2 in Treating Patients With Metastatic Melanoma
Official title: TREATMENT OF METASTATIC MELANOMA WITH RECOMBINANT INTERLEUKIN-2
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Melanoma (Skin)
Keywords: stage IV melanoma
recurrent melanoma
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2004-08-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill melanoma cells.

PURPOSE: Phase II trial to study the effectiveness of interleukin-2 in treating patients who have metastatic melanoma.

Detailed description: OBJECTIVES: I. Evaluate the response and survival rates of patients with metastatic melanoma following induction with high-dose and maintenance with low-dose interleukin-2. II. Assess the toxicity of this regimen.

OUTLINE: All patients receive high-dose interleukin-2 over 24 hours, followed by low-dose interleukin-2 for 4 days in the absence of toxicity. Patients receive a second cycle beginning 9-13 days after completion of the first cycle, with response assessed approximately 2 months after initiating therapy. Patients with stable or responding disease receive a second course as above; those with a continued response may receive additional courses provided toxicity is limited. Patients are followed for survival.

PROJECTED ACCRUAL: 20 patients will be entered.

Eligibility criteria: DISEASE CHARACTERISTICS: Histologically proven melanoma that is metastatic No tumor replacement of 25% or more of liver on CT or MRI No involvement of the CNS or a major nerve Measurable disease required

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 80%-100% Life expectancy: More than 3 months Hematopoietic: No coagulopathy (i.e., platelets less than 80,000) Hepatic: Bilirubin normal Renal: Creatinine normal Cardiovascular: No abnormal cardiac stress test in patients over 50 years of age or with possible cardiac disease suggested by history, physical exam, or EKG Pulmonary: FEV1 or VC greater than 65% of predicted in patients with significant smoking history or with suspected pulmonary disease by history, physical exam, or x-ray Other: No site of ongoing bleeding No systemic infection No HIV antibody No HBsAg No requirement for steroids No psychiatric disease that precludes informed consent or protocol treatment No second malignancy except: Basal cell skin carcinoma Carcinoma in situ of the cervix No pregnant or nursing women Negative pregnancy test required of fertile women Effective contraception required of fertile women

PRIOR CONCURRENT THERAPY: No prior interleukin-2 At least 28 days since treatment for melanoma

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
Study officials:
affiliation: Blumenthal Cancer Center at Carolinas Medical Center
name: Richard L. White, MD
role: STUDY_CHAIR
References:
Clinical trial NCT02907645: Influenza Vaccine Randomized Educational Trial: Adult
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vaccination
Influenza
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2016-09-20
Enrollment: 222
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Influenza vaccine is recommended as routine care for all individuals who are at least 6 months of age and older. Recently, questions about vaccine safety and concerns for side effects have increased, contributing to both influenza vaccine hesitancy and refusal. In an effort to educate patients, public health entities and physicians give informational handouts in various forms.

However, recent publications have found that pro-vaccine messages can have paradoxical effects on vaccine intentions, therefore further studies on vaccine related public health communication is needed. The purpose of this study is to compare the effectiveness of pro-vaccine messages of local data, pro-vaccine messages of national data, and no educational message on patient's receipt of the influenza vaccine. These results will help to understand the relationship between patient education and the intent to vaccinate and receipt of the influenza vaccine as well as to optimize educational information given to patients regarding the influenza vaccine.


Eligibility criteria: Inclusion Criteria:

* visit to study site at time of intervention

Exclusion Criteria:

* prior receipt of influenza vaccine that season

Primary outcomes:
measure: Number of participants who receive influenza vaccination on day of intervention
timeFrame: Day 0
Secondary outcomes:
measure: Number of participants who receive Influenza vaccination by the end of the influenza vaccine season
timeFrame: Up to 7 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Melissa Stockwell, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00184145: EMDR in the Treatment of Specific Phobia.
Official title: EMDR (Eye Movement Desensitization and Reprocessing) in the Treatment of Specific Phobia. A Randomised Controlled Trial.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Specific Phobia
Keywords: Specific (Animal) Phobia
EMDR
Exposure therapy
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
First posted: 2005-09-16
Enrollment: 0
Sex: ALL
Minimum age (years): 15
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose for this study is to determine whether EMDR is effective in the treatment of specific (animal) phobia.

Detailed description: Aims: To test the hypothesis that one session EMDR is more effective for the treatment of specific (animal) phobia than relaxation immediately after treatment and at follow-up. Secondly to test whether an additional one-session exposure therapy offered to both treatment groups (EMDR patients and relaxation patients) improves outcome in the EMDR-group and results in equal outcome for both treatment groups.

Eligibility criteria: Inclusion Criteria:

* Patients with Specific (Animal) Phobia

Exclusion Criteria:

* Current or past psychotic disorder
* Current substance dependence or abuse
* Serious physical illness
* Active suicidal behavior
* Bipolar affective disorder
* Pregnancy

Primary outcomes:
measure: Behavioral Approach Test towards the feared animal.
timeFrame: Before and after each treatment
Secondary outcomes:
measure: Scores on self-report questionnaires on phobic symptoms
timeFrame: Before and after both treatments
measure: Neuropsychological function
timeFrame: Before first treatment, some measures also before second treatment
measure: Cognitive strategies
timeFrame: Before both treatments
Other outcomes:
Locations:
Study officials:
name: Ludger Kaiser, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05501145: Clinical Features, Outcomes, and Therapeutics of Pregnancy-Related Aortic Dissection
Official title: Clinical Features, Outcomes, and Therapeutics of Ppregnancy-related Aortic Dissection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Dissection
Pregnancy Related
Lead sponsor: Nanjing Medical University
Sponsor class: OTHER
Collaborators: name: Beijing Anzhen Hospital
name: Shanghai Zhongshan Hospital
name: Guangdong Provincial People's Hospital
First posted: 2022-08-15
Enrollment: 75
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: From February 1 2012 through June 30 2022 for identification women who presented with aortic dissection during pregnancy or post partum ≤12 weeks

Brief summary: Aortic dissection in pregnancy represents a lethal risk to both the mother and fetus, it has yet to yield the optimal therapeutic strategy. The aim of this study was to characterize the clinical features and outcomes in women with pregnancy-related acute aortic dissection, and to suggest therapeutic guidelines.


Eligibility criteria: Inclusion Criteria:

* Women who presented with aortic dissection during pregnancy or post partum ≤12 weeks.

Exclusion Criteria:

* Loss of surgical information.

Primary outcomes:
measure: 30-day mortality
timeFrame: 30 days after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hospital
city: Guangzhou
country: China
facility: Department of Obstetrics and Gynecology, Guangdong Provincial People's Hospital
city: Qingdao
country: China
facility: Department of Cardiac Surgery, Affiliated Hospital of Qingdao University
city: Shanghai
country: China
facility: Department of Obstetrics and Gynecology, Zhongshan Hospital
Study officials:
affiliation: Beijing Anzhen Hospital
name: Hong-jia Zhang, MD
role: STUDY_CHAIR
References:
Clinical trial NCT03397745: Bispectral Index Throughout Esophageal Cancer Operation
Official title: Which Bispectral Index Score is Reliable Throughout Esophageal Cancer Operation?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Esophageal Cancer
Keywords: bispectral index
lateral decubitus position
one lung ventilation
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2018-01-12
Enrollment: 44
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The investigators try to conduct a study to assess the impact of changing patients' lateral decubitus position on BIS readings during esophageal cancer operation. Also, the investigators evaluate the effects of one-lung ventilation and total lung ventilation on BIS value with inhalation agent.

Detailed description: Bispectral index (BIS) was developed to monitor a patient's level of consciousness under general anesthesia. Several factors have been found to alter BIS readings without affecting the depth of anesthesia.Changing a patient's position (head up and head down) significantly affects the BIS values, which might affect the interpretation of anesthetic depth.

During esophageal cancer surgery, there were several factors which could affect to BIS values.First, the surgical positions are consisted with supine and lateral decubitus position more than 1 h. Thus, the investigators compare the BIS value of both side on supine and lateral decubitus position by both side approach. Second, the one lung ventilation was applied for surgical filed. It alters the oxygenation and the cerebral flow. Because of these effects, the BIS monitoring can differ by the period of surgery. Thus, in this study, the BIS value of both side monitor throughout the surgery.

Eligibility criteria: Inclusion Criteria:

the patients who are planned the esophageal cancer operation

Exclusion Criteria:

* patient who has dermatitis
* patient who refuse to participate in this study

Primary outcomes:
measure: Change in Bispectral index score
timeFrame: after lateral decubitus position 5 mins, 10 mins, 20 mins, 30 mins
Secondary outcomes:
measure: the asymmetry of BIS
timeFrame: after supine position 5 mins, 10 mins, 20 mins, 30 mins
measure: oxygenation and BIS
timeFrame: intraoperative
measure: The changes of BIS
timeFrame: intraoperative
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung medical center
Study officials:
References:
Clinical trial NCT00405145: Mapping of the Epileptic Brain
Official title: Mapping of the Eloquent Cortex and of Epileptic Networks Using Functional Magnetic Resonance Imaging and Electroencephalography in Epileptic Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Epilepsy
Keywords: Epilepsy
MRI
EEG
Neuroimaging
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
name: Centre National de la Recherche Scientifique, France
First posted: 2006-11-29
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: OTHER

Brief summary: This study aims improving the outcome after brain resective surgery of epileptic patients by improving presurgical evaluations. In particular the specific goal is to evaluate the ability of non invasive neuroimaging (functional magnetic resonance imaging and electroencephalography) to provide presurgical maps of the functional areas of the brain and of the epileptogenic networks.


Eligibility criteria: Inclusion Criteria:

* Epilepsy

Exclusion Criteria:

* MRI incompatible
* Pregnancy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Grenoble
country: France
facility: UniversityHospitalGrenoble
state: Isere
Study officials:
affiliation: Institut National de la Santé Et de la Recherche Médicale, France
name: Olivier David, PhD
role: STUDY_CHAIR
affiliation: University Grenoble Hospital
name: Jean-François Le Bas, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05432245: MINIject Implantation Combined With Cataract Surgery in Patients With POAG and Cataract
Official title: A Prospective, Open, Multicenter Clinical Trial Evaluating the Efficacy and Safety of MINIject Combined With Cataract Surgery in Patients With POAG Uncontrolled by Topical Hypotensive Medications and Operable Age-related Cataract Diagnosis
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Primary Open-angle Glaucoma
Cataract
Keywords: Primary Open-angle Glaucoma (POAG)
Cataract
Intra Ocular Pressure (IOP) reduction
Glaucoma Drainage Device
Minimally Invasive Glaucoma Surgery (MIGS)
Supraciliary space
Combined procedure (POAG and phacoemulsification)
Lead sponsor: iSTAR Medical
Sponsor class: INDUSTRY
First posted: 2022-06-27
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study will assess safety and performance of MINIject implant in patients with open-angle glaucoma uncontrolled by topical hypotensive medications in conjunction with cataract surgery.

Detailed description: The study aims to evaluate the safety and efficacy of the MINIject in the reduction of intraocular pressure (IOP) in patients with primary open-angle glaucoma (POAG) in conjunction with cataract surgery. The cataract surgery will be performed first and if successful, only then will the MINIject be placed.

Patients will be followed for 2 years after the date of their implantation. Standard ophthalmologic assessments including measurement of intraocular pressure, fundus examination, ocular imaging, assessment of any untoward ocular events etc. will be performed.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of primary open angle glaucoma (POAG) in the study eye
* Operable age-related cataract eligible for phacoemulsification surgery with Intraocular Lens (IOL) implantation
* Glaucoma not adequately controlled with at least one topical hypotensive medication(s), unless the patient has an allergy / intolerance to a medication
* Patient must provide written informed consent to participate

Exclusion Criteria:

* Known or suspected allergy or hypersensitivity to medical silicone
* Allergy to fluorescein
* Presence of silicone oil in the study eye
* Individuals under tutorship or trusteeship
* Patient has a condition such that his / her ability to provide personal informed consent is compromised

Primary outcomes:
measure: Proportion of study eyes achieving ≥ 20% reduction in diurnal IOP
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Panama City
country: Panama
facility: Panama Eye Center
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Colchester
country: United Kingdom
facility: East Suffolk and North Essex NHS Foundation Trust - Colchester General Hospital
state: Essex
city: Edinburgh
country: United Kingdom
facility: Princess Alexandra Eye Pavilion
Study officials:
affiliation: iSTAR Medical
name: Zubair Hussain, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04801745: Vegan Diet, Amla Fruits and Uric Acid
Official title: Effects of a Healthy Vegan Diet Vs. Low Purine Diet, with or Without Amla Fruits (Emblica Officinalis) on Hyperuricemia and Other Cardiometabolic Risk Factors: a Randomized Two-by-two Factorial Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperuricemia
Diet, Healthy
Cardiometabolic Syndrome
Keywords: Vegan diet
Uric acid
Cardiometabolic risk factors
Amla fruits
Lead sponsor: Fu Jen Catholic University
Sponsor class: OTHER
First posted: 2021-03-17
Enrollment: 102
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: This is an intervention study aiming to test the effectiveness of a vegan diet, My Plate with low purine choices, and amla fruits on uric acid and other cardiometabolic risk factors in individuals with high serum uric acid levels.

Detailed description: Ninety-two participants with hyperuricemia will be randomly assigned to one of these 4 diet interventions: (1) vegan, (2) vegan with amla fruits, (3) my plate-low purine, (4) my plate-low purine with amla fruits. During the 3 months intervention phase, participants will attend group lessons and individual nutrition counseling sessions to assist adherence to the diet. At baseline, end of 3 months, and 1 year, participants will be measured on uric acid and other cardiometabolic risk factors, and some nutritional markers. Amla fruits powder, and some foods encouraged in each dietary arm will be provided to enhance adherence during the 3 months intervention phase.

Eligibility criteria: Inclusion Criteria:

* Men with serum uric acid \> 7mg/dL
* Women with serum uric acid \> 6mg/dL
* Willing to make diet changes according to dietary interventions

Exclusion Criteria:

* Age \<19
* With cancer diagnosis
* With diseases that require special dietary needs
* On urate-lowering medication within 3 months

Primary outcomes:
measure: Uric acid
timeFrame: 3 months
Secondary outcomes:
measure: Body mass index
timeFrame: 3 months
measure: Glucose metabolism
timeFrame: 3 months
measure: Lipid profile
timeFrame: 3 months
measure: vitamin B12
timeFrame: 3 months
measure: holostranscobalamin
timeFrame: 3 months
measure: homocysteine
timeFrame: 3 months
measure: vitamin D
timeFrame: 3 months
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Department of Nutritional Science, Fu-Jen Catholic University
Study officials:
affiliation: Fu-Jen Catholic University, Department of Nutritional Science
name: Tina Hsueh-Ting Chiu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01710345: Safety and Efficacy of Sufentanil NanoTab for Management of Acute Pain Following Bunionectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Pain
Lead sponsor: Talphera, Inc
Sponsor class: INDUSTRY
First posted: 2012-10-19
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a dose-finding study to determine if the sublingual administration of the Sufentanil NanoTab is safe and effective in the treatment of post-operative pain.


Eligibility criteria: Inclusion Criteria:

* patients scheduled for bunion surgery

Exclusion Criteria:

* daily opioid use
* drug or alcohol abuse
* pregnant or breastfeeding women

Primary outcomes:
measure: SPID-12
timeFrame: 12 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Pasadena
country: United States
facility: Lotus Clinical Research
state: California
city: Salt Lake City
country: United States
facility: Jean Brown Research
state: Utah
Study officials:
References: