louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03412539: Mechanism of Effectiveness of Neurosurgery Treatments for Durable Pain
Official title: Mechanism of Effectiveness of Neurosurgery Treatments for Durable Pain
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: Oncology Problem
Keywords: resistant pain
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: University of Haifa
First posted: 2018-01-26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT

Brief summary: The participants in the study are patients who undergo surgery to damaged nerve transmission and processing system in the nervous system as part of the routine clinical treatment that will not be affected by the proposed study. Patients who are candidates for procedures are referred from all over the country and undergo a multidisciplinary evaluation in the framework of the Palliative Pain Management Clinic, which operates exclusively in Israel at the Sourasky Medical Center in Tel Aviv.

Detailed description: The participants in the study are patients who undergo surgery to damaged nerve transmission and processing system in the nervous system as part of the routine clinical treatment that will not be affected by the proposed study. Patients who are candidates for procedures are referred from all over the country and undergo a multidisciplinary evaluation in the framework of the Palliative Pain Management Clinic, which operates exclusively in Israel at the Sourasky Medical Center in Tel Aviv.

During the preoperative evaluation, patients will be given an explanation about the possibility of participating in the study. Patients who agree to participate will sign an informed consent form.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing neurosurgical surgery for resistant pain
* Ability to sign informed consent form for participation in the study
* A functional level is sufficient for cooperation and the performance of various tasks before and after surgery, including performing MRI's, answering pain questioners, and neuropsychological evaluations.

Exclusion Criteria:

* Refusal to participate
* Pregnant women

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Neurosurgery, Tel-Aviv Sourasky MC
Study officials:
References:
Clinical trial NCT00296439: Nutrition Counseling to Lower Serum Phosphorus Levels
Official title: Comparison of Different Counseling Methods on Serum Phosphorus Levels in Renal Patients at Hines VA Hospital
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hemodialysis
Nutrition
Lead sponsor: Edward Hines Jr. VA Hospital
Sponsor class: FED
First posted: 2006-02-27
Enrollment: 44
Sex: ALL
Minimum age (years): 19
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: ECT

Brief summary: Hemodialysis patients who receive frequent weekly nutrition counseling using motivational interviewing techniques will have lower serum phosphorus levels compared to patients receiving standard treatment.

Detailed description: Hemodialysis patients will receive weekly nutrition counseling on how to lower their serum Phosphorus levels. Motivational interviewing techniques and strategies will be employed such as reflective listening, using affirmations, and summarizing. Average serum Phosphorus levels pre-dialysis will be compared to s.Ph post counseling. This will be compared to a group receiving nutrition counseling via standard treatment on a monthly basis.

Eligibility criteria: Inclusion Criteria:

* ESRD patients on dialysis with serum Ph \> 5.5 mg/dL four of six labs over 6 months, mentally competent

Exclusion Criteria:

* ESRD patients on dialysis with serum Ph \< 5.5 mg/dL four of six labs over 6 months, mentally incompetent

Primary outcomes:
measure: serum Phosphorus levels
Secondary outcomes:
Other outcomes:
Locations:
city: Hines
country: United States
facility: Edward Hines,Jr., VA Hospital
state: Illinois
city: Hines
country: United States
facility: Hines VA Hospital
state: Illinois
Study officials:
affiliation: Hines VA Hospital
name: Sharon Foley, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06575439: An Observational Study of Predictors and Outcomes of Lung Cancer in Never-smokers in the UK
Official title: An Observational Study of Predictors and Outcomes of Lung Cancer in Never-smokers in the UK
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Cancer
Lead sponsor: University College London Hospitals
Sponsor class: OTHER
First posted: 2024-08-28
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will aim to recruit participants who have been diagnosed or treated with primary lung cancer at any participating study site.

Brief summary: The goal of this observational study is to improve the early detection of lung cancer in adults who have smoked less than 100 tobacco cigarettes ("never-smokers") in the United Kingdom. The main questions it aims to answer are:

* To describe characteristics such as demographics, co-morbidities and environmental exposures
* To describe participant pathways including presentation mode and symptoms to understand if earlier diagnosis would be possible
* To describe participant outcomes such as cancer stage, treatment and mortality
* To quantitatively or qualitatively measure modifiable and non-modifiable factors that may be associated with LCINS including environmental measures, blood tests and genomic data.

Participants will currently have no change to their usual care.


Eligibility criteria: Inclusion Criteria:

* All adult participants from age of 18 who are diagnosed or treated with primary lung cancer through radiology or histology at any participating study site

Exclusion Criteria:

* Participants who have ever smoked cigarettes or tobacco will be excluded; this is defined as:

  * More than 100 cigarettes or 75g tobacco in their lifetime
  * Those who have received a prescription for nicotine replacement therapy
* For prospective participants, those who cannot consent will be excluded

Primary outcomes:
measure: Demographics, comorbidities and environmental exposures of participants
timeFrame: Comorbidities and environmental exposures at diagnosis (approximately up to 156 weeks prior to diagnosis)
measure: Participant pathways including presentation mode and symptoms
timeFrame: Presentation mode and symptoms at time of diagnosis (approximately up to 52 weeks prior to diagnosis)
Secondary outcomes:
measure: Participant outcomes such as cancer stage, treatment, mortality
timeFrame: Cancer stage at time of diagnosis, treatment and mortality through study completion (likely 5 years)
measure: Measurement of modifiable and non-modifiable factors associated with LCINS
timeFrame: Through study completion (likely 5 years)
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: University College London Hospital
Study officials:
References:
Clinical trial NCT06566339: Robotic OCT for ER Anterior Eye Exams
Official title: Robotically Assisted Anterior Eye Examinations for Acute Eye Care
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Develop and Test Robotically Assisted Imaging System for the Front of the Eye
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2024-08-22
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to develop and test a robotically assisted imaging system for the front of the eye with a goal of helping eye care through the emergency department.


Eligibility criteria: Inclusion Criteria:

* Adult patients 18 years of age and older
* Presenting with ocular complaints potentially indicative of an anterior segment pathology (e.g., foreign body sensation, red eye, pain)

Exclusion Criteria:

* Hemodynamically unstable patients (e.g., undergoing active resuscitation efforts)
* Patients with potential penetrating trauma to the eye who may need immediate surgical care

Primary outcomes:
measure: Sensitivity
timeFrame: Day 1
measure: Specificity
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Eye Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Anthony Kuo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04699539: Different Patterns of Target Delineation in SBRT for Locally Advanced Pancreatic Cancer
Official title: GTV Uniform Expansion to Form PTV vs. Non-uniform Expansion to Form PTV Based on Recurrence Pattern in SBRT of Locally Advanced Pancreatic Cancer: a Phase II Clinical Prospective Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Treatment
Keywords: SBRT
Locally Advanced Pancreatic Cancer
Target Delineation
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2021-01-07
Enrollment: 86
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: The purpose of this study is to compare the efficacy and safety of two target delineation methods in SBRT for LAPC, so as to determine whether the target delineation method based on recurrence pattern can obtain better survival benefits.


Eligibility criteria: Inclusion Criteria:

* Age 18-75
* Patients with a pathological diagnosis of pancreatic ductal adenocarcinoma or clinical diagnosis of pancreatic cancer after clinical multiple disciplinary team
* Patients with a clinical staging of locally advanced pancreatic cancer
* No anti-tumor treatment related to pancreas before SBRT
* Performance status is acceptable, ECOG score is 0 or 1
* Patients who voluntarily accepted the clinical trial program after informing the existing treatment plan

Exclusion Criteria:

* Patients who have previously received relevant treatments in the pancreas and its surrounding areas, such as radiotherapy, chemotherapy, and local treatment
* Severe liver and kidney dysfunction
* Obstructive jaundice
* Moderate or mass ascites
* Patients with other malignant tumors, acute infection or other severe infection
* Patients with gastrointestinal ulcers and incomplete recovery, or patients with acute peptic ulcer
* Gastroscopy or imaging examination indicates that the tumor invaded the duodenum or stomach
* Patients who have participated in other clinical trials for less than three months
* Patients who are judged by researchers as unsuitable for this clinical trial

Primary outcomes:
measure: 1-year Local Control Rate (1y-LCR)
timeFrame: 1-year
Secondary outcomes:
measure: The Probability of gastrointestinal (GI) Toxicity
timeFrame: 1-year
measure: 1-year Disease Progression-Free-Survival (DPFS)
timeFrame: 1-year
measure: Overall Survival(OS)
timeFrame: 1-year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changhai hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT01129622: Effect of Aromatase Inhibitors on Breast Magnetic Resonance Imaging (MRI)
Official title: Phase II Study of the Effect of Acute Aromatase Inhibition on Breast MRI Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Keywords: Letrozole
Breast MRI
Postmenopausal women
Lead sponsor: Mount Sinai Hospital, Canada
Sponsor class: OTHER
First posted: 2010-05-24
Enrollment: 16
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study is a primary investigation to determine the usefulness and safety of a short course of a relatively high dose of letrozole (a medication used to decrease the female hormone estrogen which is produced locally inside the breast after menopause) in improving the performance of of breast MRI (Magnetic Resonance Imaging). The inhibition of estrogen in the breast by letrozole might help better identifying of suspicious areas in the breast and could assist radiologists in distinguishing between benign breast areas and cancer tissue. This might help reducing the rate of call backs and unnecessary biopsies for patients. We expect to enroll 20 healthy postmenopausal women in this study.

Detailed description: A breast MRI will be performed in the standard way for diagnosis and to serve as a baseline. A second MRI will be performed within a month and following administration of letrozole 12.5 mg daily for three days to reduce breast estrogen levels and in anticipation of lowering breast gadolinium dye uptake.

Eligibility criteria: Inclusion Criteria:

* Women are eligible to participate if they are 40 years or older and have been menopausal (had no menstrual bleeding during the past 12 months)

Exclusion Criteria:

* History of bilateral mastectomy, osteoporosis or renal impairment.

Primary outcomes:
measure: Number of Women With Reduced Breast Parenchymal Enhancement
timeFrame: One month MRI study after letrozole compared to baseline MRI study, both with gadolinium enhancement
Secondary outcomes:
measure: Number of Participants Developed Adverse Effects of 12.5 mg of Letrozole
timeFrame: Three days plus One Week following medication
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
Study officials:
affiliation: Mount Sinai Hopsital
name: Robert F Casper, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mousa NA, Eiada R, Crystal P, Nayot D, Casper RF. The effect of acute aromatase inhibition on breast parenchymal enhancement in magnetic resonance imaging: a prospective pilot clinical trial. Menopause. 2012 Apr;19(4):420-5. doi: 10.1097/gme.0b013e31823772a8.
Clinical trial NCT01332422: Special Drug Use Investigation for ADOAIR Metered-dose Inhaler (Pediatric)
Official title: Special Drug Use Investigation for ADOAIR Metered-dose Inhaler (Pediatric)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2011-04-11
Enrollment: 300
Sex: ALL
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Japanese pediatric patients (aged \< 15 years) who diagnosed as having bronchial asthma for which the indication of ADOAIR has been approved and who are using ADOAIR for the first time and expected for a long-term use.

Brief summary: To investigate possible problems or questions in safety and efficacy of ADOAIR 100 DISKUS and ADOAIR 50 AEROSOL 120 in Japanese pediatric patients with bronchial asthma for a long term under the practical use conditions. In this special drug use investigation, the following items shall be handled as the priority investigation items for information collection.

1. Systemic effects accompanying steroid administration; influences on adrenocortical function, influences on bone metabolisms (fracture, osteoporosis, etc.), cataract, glaucoma
2. Events related to nervous system, musculoskeletal system and circulatory system; tremor, headache, cramp, tachycardia, etc.


Eligibility criteria: Inclusion Criteria:

* ADOAIR must be used for the first time
* ADOAIR used for a long-term

Exclusion Criteria:

* Patients with hypersensitivity to salmeterol and fluticasone
* Patients with infection which salmeterol and fluticasone is not effective
* Patients with deep mycosis

Primary outcomes:
measure: Safety and efficacy for a long term under the practical use conditions. As the priority investigation items, (1)Systemic effects accompanying steroid administration (2) Events related to nervous system, musculoskeletal system and circulatory systems
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT02602522: Danshen-Jiang-Fu Granule Prepared by Danshen From Different Producing Areas for Primary Dysmenorrhea
Official title: The Comparison of the Effect on Danshen-Jiang-Fu Granule Prepared by Danshen (Salvia Miltiorrhiza) From Different Producing Areas (Shandong and Sichuan) for Primary Dysmenorrhea: a Cross-over, Randomized, Double-blind Controlled Trials
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Primary Dysmenorrhea
Traditional Chinese Medicine
Lead sponsor: China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2015-11-11
Enrollment: 91
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This trial aims to compare the effect of Danshen-Jiang-Fu Granule prepared by Danshen (Salvia Miltiorrhiza) from different producing areas (Shandong and Sichuan) for the relief of primary dysmenorrhea.


Eligibility criteria: Inclusion Criteria:

* meeting the diagnostic criteria of primary dysmenorrhea in the Primary Dysmenorrhea Consensus Guideline;
* meeting the diagnostic criteria of Hanning-xueyu(blood stasis due to cold accumulation) Zheng according to Gynecology of Chinese medicine;
* with regular menstrual cycles lasted 21 to 35 days, with menstruation lasting 3 to 9 days in the last 6 months;
* course of dysmenorrhea over 6 months;
* experienced menstrual pain scoring varying from 3cm to 6cm on a 10-cm VAS during the baseline menstrual period (one period prior to present menstrual period with treatment);
* without history of pregnancy;
* with agreement of informed consent and a working phone.

Exclusion Criteria:

* history of abdominal surgery;
* with other acute or chronic painful conditions diagnosed or suspected;
* use of hormonal contraceptives, or intra-uterine device;
* use of analgetic drugs or other analgetic treatment in the last 2 weeks;
* known allergy to Danshen (Salvia Miltiorrhiza), Paojiang (Roasted Ginger), Xiangfu(Rhizoma Cyperi) or Wuyao(Lindera Aggregata);
* prone to allergy in daily life;
* who can not complete treatment adherence to the protocol;
* attending in other trials in the last 3 months.

Primary outcomes:
measure: Visual Analogue Scale on the pain of dysmenorrhea
timeFrame: 2 months
Secondary outcomes:
measure: Cox Menstrual Symptom Scale
timeFrame: 2 months
measure: Daily Symptom Scale
timeFrame: 2 months
measure: The change on the index of uterine artery doppler ultrasound
timeFrame: 2 months
Other outcomes:
Locations:
city: Changzhou
country: China
facility: Changzhou TCM hospital
state: Jiangsu
Study officials:
affiliation: Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
name: Zhong Wang, Ph.D/M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00981422: Search for Biomarkers in Human Glaucoma: Lymphocytes Alterations and Rate of Progression
Official title: Search for Biomarkers in Human Glaucoma: Possible Correlations Between Alterations in Peripheral Lymphocytes and Disease Severity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glaucoma, Open-Angle
Keywords: glaucoma
immunology
immunophenotype
Lead sponsor: University of Parma
Sponsor class: OTHER
First posted: 2009-09-22
Enrollment: 40
Sex: ALL
Minimum age (years): 19
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care clinic in Parma (University hospital of Parma)

Brief summary: The aim of this study was to evaluate the lymphocyte phenotype in primary open- angle glaucoma (POAG) patients compared to healthy subjects of the same age, in order to confirm the importance of immune responses in glaucoma and the possible correlation to the severity of the disease.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of primary open-angle glaucoma
* age between 19 an 85 years old

Exclusion Criteria:

* age less than 19 or more than 85 yrs
* positive history for (a) neurodegenerative diseases, (b) autoimmune diseases, (c) cancer, (d) viral infection and (e) diabetes, (f)systemic inflammation

Primary outcomes:
measure: compare the lymphocyte phenotype of POAG patients to healthy subjects of the same age
timeFrame: the same day of bloodwithdrawal
Secondary outcomes:
measure: correlate the immunophenotype of POAG patients to the severity of disease
timeFrame: within 3 months after blood withdrawal
Other outcomes:
Locations:
city: Parma
country: Italy
facility: Azienda ospedaliera universitaria
Study officials:
affiliation: Ophthalmology Institute, University of Parma, Italy
name: Stefano A Gandolfi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02723422: Transcatheter Aortic Valve Replacement (TAVR)-Pilot Trial
Official title: Intensive Versus Usual Home-based Physical Therapy to Promote Functional Recovery After Transcatheter Aortic Valve Replacement (TAVR): A Pilot Randomized Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Transcatheter Aortic Valve Replacement (TAVR)
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2016-03-30
Enrollment: 0
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary purpose of this this randomized interventional study is to determine if increased level of home-based rehabilitation coupled with a pre-TAVR consultation visit in transcatheter aortic valve replacement patients will improve functional status and quality of life and will decrease hospital readmission.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of severe aortic stenosis (AS) as determined by echocardiography, who are deemed eligible for TAVR by the NYULMC Heart Valve Team

Exclusion Criteria:

* Decisional impairment as assessed by the University of California, San Diego Brief Assessment of Capacity to Consent (UBACC)
* Non-English/non-Spanish speaking.

Primary outcomes:
measure: Change in level of Activity measured by activity monitor called the ActiGraph wGT3X-BT.
timeFrame: Baseline, 2 Weeks
measure: Change in self-perceived physical health
timeFrame: Baseline, 2 Weeks
measure: Change in Independence in activities of daily living (ADLs).
timeFrame: Baseline, 2 Weeks
Secondary outcomes:
measure: Reduction in hospital readmissions following intensive home-based physical therapy reduces
timeFrame: Baseline, 2 Weeks
Other outcomes:
Locations:
Study officials:
affiliation: New York University Medical School
name: John Dodson, MD
role: PRINCIPAL_INVESTIGATOR
References: