louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00824720: Safety and Efficacy of a Glaucoma Drug Delivery System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Glaucoma, Open-Angle
Ocular Hypertension
Lead sponsor: Vistakon Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2009-01-19
Enrollment: 55
Sex: ALL
Minimum age (years): 21
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 evaluate the ocular safety and efficacy of a glaucoma drug delivery system in open-angle glaucoma or ocular hypertension.


Eligibility criteria: Inclusion Criteria:

* Man or woman 21 years of age or greater
* must have open angle glaucoma or ocular hypertension.
* Corrected visual acuity in each eye of 20/200 or better.

Exclusion Criteria:

* Previous glaucoma intraocular surgery or refractive surgery.
* Planned contact lens use during the study.
* Clinically significant ocular or systemic disease that might interfere with the study.
* Use of chronic corticosteroids by any route.

Primary outcomes:
measure: Visual Acuity - Right Eye
timeFrame: at 14 days
measure: Visual Acuity - Left Eye
timeFrame: at 14 days
Secondary outcomes:
measure: Intraocular Pressure (IOP)
timeFrame: from baseline to 14 days
Other outcomes:
Locations:
city: Artesia
country: United States
state: California
city: Louisville
country: United States
state: Kentucky
city: Baltimore
country: United States
state: Maryland
city: Mount Pleasant
country: United States
state: South Carolina
Study officials:
References:
Clinical trial NCT06588920: Brain Activity, Cognitive Function, and Walking Ability in Parkinson's Disease
Official title: Brain Activity, Cognitive Function, and Walking Ability in People With Parkinson's Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Healthy Older Adults
Parkinson Disease
Keywords: Executive function
Gait
Electroencephalography
Lead sponsor: National Yang Ming Chiao Tung University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 70
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospital and community

Brief summary: The dual-task automated walking performance in people with Parkinson\&#39;s disease (PD) is affected by their gait disturbances and impaired executive functions. Currently, the relationship between brain activity related to inhibitory control, executive functions, and dual-task walking performance in people with PD is not well understood. Therefore, this study aims to investigate the significance of different executive function domains on gait stability in healthy older adults and people with PD; whether brain activation related to inhibitory control is associated with gait stability in healthy older adults and people with PD.


Eligibility criteria: Inclusion Criteria:

* Diagnoses of idiopathic Parkinson disease
* Stable dopaminergic medicine ≥ 2 weeks
* Able to walk 10 meters without aid
* Mini-Mental Status Examination ≥ 24 points
* No uncorrected visual or auditory disorders
* Education at least junior high school
* No other disease may affect balance

Exclusion Criteria:

* Other medical diagnoses of neurological, musculoskeletal, or cardiopulmonary disorders
* History of brain surgery (e.g. deep brain stimulation)

Primary outcomes:
measure: Gait variability
timeFrame: 1 day
measure: Gait speed
timeFrame: 1 day
measure: Step length
timeFrame: 1 day
measure: Step width
timeFrame: 1 day
measure: Single support time
timeFrame: 1 day
measure: Double support time
timeFrame: 1 day
measure: Frontal Assessment Battery
timeFrame: 1 day
measure: Trail making test
timeFrame: 1 day
measure: Stroop color and word test
timeFrame: 1 day
measure: Digit span test
timeFrame: 1 day
measure: Event-related potential - N2
timeFrame: 1 day
measure: Event-related potential - P300
timeFrame: 1 day
measure: Go/Nogo test
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Yang Ming Chiao Tung University
city: Taipei
country: Taiwan
facility: National Yang Ming Chiao Tung University
Study officials:
References:
Clinical trial NCT03280420: Early Versus Late Catheter Removal in Patients With Acute Urinary Retention Secondary to BPH Under Tamsulosin Treatment
Official title: Early Versus Late Catheter Removal in Patients With Acute Urinary Retention Secondary to Benign Prostatic Hyperplasia Under Tamsulosin Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: BPH With Urinary Obstruction
Keywords: Acute urinary retention
BPH
TWOC
Tamsulosin
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2017-09-12
Enrollment: 60
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All patients were catheterized and received urinary antiseptic and then randomly divided into two groups : Group I :30 patients received Tamsulosin 0.4 mg once daily and catheter removed after 3 days. Group II :30 patients received Tamsulosin 0.4 mg once daily and catheter removed after 7 days.
Primary purpose: TREATMENT

Brief summary: The aim of this work is to compare between early (3days) and late(7days) removal of urinary catheter after acute urine retention in patients with Benign Prostatic Hyperplasia under Tamsulosin treatment.

Detailed description: This is a prospective randomized study, Men with acute urinary retention secondary to benign prostatic hyperplasia were catheterized and then, if they fulfilled the entry criteria, were randomly assigned to receive 0.4 mg tamsulosin hydrochloride for three days or seven days, After that the catheter was removed and the ability to void unaided assessed.

Eligibility criteria: Inclusion Criteria:

* Patients having first attack of acute urinary retention secondary to BPH.

Exclusion Criteria:

* Renal impairment.
* Suspected urethral stricture.
* Neurogenic bladder.
* Cancer prostate.
* Medically induced retention.
* Previous use of alpha blockers.
* History of drug hypersensitivity or allergy to Tamsulosin.

Primary outcomes:
measure: The duration for trial without catheter
timeFrame: 6 Months
Secondary outcomes:
measure: Factor affecting trial without catheter
timeFrame: 6 Months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of medicine ,Al Azhar university
state: El Mokhayam El Daem St.، Ezbet El-Arab, Nasr City, Cairo
Study officials:
affiliation: Al-Azhar University
name: Mohamed M Badr, PHD
role: STUDY_CHAIR
affiliation: Al-Azhar University
name: Mohamed F El Saeed El Ebiary, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06820320: Oral Iohexol in the Management of Chylous Ascites After After Retroperitoneal or Extended Lymphadenectomy
Official title: Oral Iohexol in the Management of Chylous Ascites After Retroperitoneal or Extended Lymphadenectomy for Abdominal or Pelvic Malignant Tumor: an Innovative and Convenient Treatment
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Chylous Ascites
Abdominal Neoplasm
Pelvic Neoplasms
Retroperitoneal Lymph Node Metastasis
Retroperitoneal Lymphadenectomy
Extended Lymphadenectomy
Keywords: Oral Iohexol
Chylous Ascites
Retroperitoneal Lymphadenectomy
Extended Lymphadenectomy
Abdominal Malignant Tumor
Pelvic Malignant Tumor
Lead sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sponsor class: OTHER
First posted: 2025-02-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to assess the effectiveness of oral iohexol in the treatment of postoperative chylous ascites. It will also learn about the safety of oral iohexol. The main questions it aims to answer are:

* Confirm the potential of oral iohexol as an innovative therapeutic regimen.
* Confirm its ability to improve clinical outcomes for patients.


Eligibility criteria: Inclusion Criteria:

* Patients between the ages of 18 and 75 years;
* Patients underwent retroperitoneal or extended lymphadenectomy for abdominal or pelvic malignant tumors;
* Patients diagnosisted with postoperative Chylous ascites. Chylous ascites were defined by the presence of non-infectious, milky, or creamy effluent in drainage tubes surpassing 200 mL daily, paired with triglyceride concentrations exceeding 110 mg/dL

Exclusion Criteria:

* Patients with severe cardiac, hepatic and renal insufficiency;
* Patients with a history of iohexol allergy or allergy to contrast media;
* Patients who have received other interventions;
* Patients with severe intestinal obstruction or intestinal perforation;
* Patients who are unable to comply with the requirements of the study or are unable to complete follow-up.

Primary outcomes:
measure: grading system for efficacy of iohexol intervention
timeFrame: up to 3 weeks after the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
state: Beijing
Study officials:
References:
citation: Grist TM, Canon CL, Fishman EK, Kohi MP, Mossa-Basha M. Short-, Mid-, and Long-term Strategies to Manage the Shortage of Iohexol. Radiology. 2022 Aug;304(2):289-293. doi: 10.1148/radiol.221183. Epub 2022 May 19.
Clinical trial NCT03328520: WILD 5 Wellness, A 30-Day Intervention
Official title: WILD 5 Wellness, A 30 Day Intervention in First Year Students at Beloit College
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Depression
Cognitive Functioning
Wellness
Lead sponsor: Beloit College
Sponsor class: OTHER
First posted: 2017-11-01
Enrollment: 33
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is to explore the efficacy and feasibility of an integrated, prescriptive, and trackable wellness intervention combining five wellness elements including exercise, mindfulness, sleep, social connectedness, and nutrition in First Year Beloit College students self-selected into a wellness focused first year initiative. This program is called "WILD 5 Wellness: A 30-Day Intervention".


Eligibility criteria: Inclusion Criteria:

* Students 18 years of age or older or 17 years of age with legal guardian written permission.
* Students enrolled in First Year Initiative Courses titled "Balance" or "Constructing Health"

Exclusion Criteria:

* Individuals who are pregnant or plan to get pregnant during the next 30 days.
* Students who are not enrolled in the First Year Initiative Courses titled "Balance" or "Constructing Health"

Primary outcomes:
measure: Change in Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Day 0, Day 30+ 3 days (approximately)
measure: Change in Generalized Anxiety Disorder-7 (GAD-7)
timeFrame: Day 0, Day 30+ 3 days (approximately)
measure: Change in the HERO Wellness Scale
timeFrame: Day 0, Day 30+ 3 days (approximately)
measure: Change in World Health Organization-5 (WHO-5)
timeFrame: Day 0, Day 30+ 3 days (approximately)
measure: Change in Cognitive and Physical Functioning Questionnaire (CPFQ)
timeFrame: Day 0, Day 30+ 3 days (approximately)
Secondary outcomes:
measure: The Post-Program Participant Questionnaire
timeFrame: Day 30+ 3 days (approximately)
Other outcomes:
Locations:
city: Beloit
country: United States
facility: Beloit College
state: Wisconsin
Study officials:
affiliation: Beloit College
name: Tara M Girard, BSN
role: PRINCIPAL_INVESTIGATOR
affiliation: Beloit College
name: Suzanne Cox, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Beloit College
name: Laura Parmentier, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Beloit College
name: Saundra Jain, PsyD, LPC
role: PRINCIPAL_INVESTIGATOR
affiliation: Beloit College
name: Rakesh Jain, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04497220: Poke and a Placebo
Official title: Will Negative Phrasing Create a Nocebo Effect During Epidural Placement When Compared to Positive Phrasing? A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anesthesia
Keywords: Epidural Anesthesia (labor)
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2020-08-04
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To discover if a positive description of the procedure for an epidural can reduce the overall pain score associated with the procedure.

Detailed description: The study intervention consists of two separate scripts read to the patient by the anesthesiologist performing their labor epidural. One script will contain the wording "Poke and a burn" prior to subcutaneous local anesthetic administration for the epidural placement and one will contain "this is numbing medication, which will make the rest of the procedure go easier". There will be no difference in the epidural placement, medications, or the rest of the script.

Eligibility criteria: Inclusion Criteria:

* pregnancy
* requesting an epidural for the first time

Exclusion Criteria:

* previous epidural (either for labor or for surgery)
* BMI greater than 40 kg/m\^2
* previous lumbar spine surgery
* inability to speak English
* a history of chronic pain or are on chronic opioids
* a history of opioid drug abuse

Primary outcomes:
measure: Max pain score during the epidural procedure
timeFrame: 1 hour
Secondary outcomes:
measure: Overall satisfaction during the epidural procedure
timeFrame: 1 hour
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Aaron Berg, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04822220: The Effect of Self-Management Program Based on the Individual and Family Self-management Theory on Cancer Patients
Official title: The Effect of Self-Management Program Based on the Individual and Family Self-management Theory on Fatigue, Daily Life Activities and Wellness on Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oncology
Fatigue
Patient
Keywords: nursing
cancer patients
self-management
fatigue
activities of daily living
well-being
randomized controlled trial
Lead sponsor: Akdeniz University
Sponsor class: OTHER
First posted: 2021-03-30
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a randomized controlled trial consisting of two groups: experimental and control.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to evaluate the effect of Self-Management Program based on the Individual and Family Self-management Theory on fatigue, daily living activities and well-being of cancer patients.


Eligibility criteria: Inclusion Criteria:

* Inpatients for symptom management or supportive care in oncology wards
* Patients who were at first two days of hospitalization
* Patients who had score of 3≤ or ≤7 in Fatigue Visual Analogue Scale (VAS)
* Patients who had score of ≤5 in Pain Analog Visual Scale (VAS)
* Patients who had score of ≤5 The Modified Borg Scale
* Patients who had score of 0, 1, 2 or 3 in ECOG Performance scale
* Patients who had metastases
* Patients who were over 18 years of age
* Patients who had orientation of person, place and time
* Patients who had no communication barriers
* Patients who agreed to participate in the study

Exclusion Criteria:

* Patients who had hospitalized for the purpose of receiving chemotherapy
* Patients whose Hb value was ≤8 g / dl
* Patients whose body temperature ≥ 38.5 ° C within the last 24 hours
* Patients who had diarrhea in the last 24 hours (frequency of defecation ≥ 3 / day)
* Patients who had a score of ≤ 16 kg / m2 in Body Mass Index (BMI)
* Patients who had advanced heart failure
* Patients who had untreated hypothyroidism
* Patients who diagnosed with major depression and / or treated for depression
* Patients who had no family member involved in their care

Primary outcomes:
measure: Change From Baseline in fatigue on the Brief Fatigue Inventory at week 8
timeFrame: Baseline, 2 week, 4 week, 8 week
Secondary outcomes:
measure: Change From Baseline in daily living activities on the Katz Index of Independence at week 8
timeFrame: Baseline, 2 week, 4 week, 8 week
measure: Change From Baseline in well-being on Well-Being Questionnaire (22 items) (W-BQ22) at week 8
timeFrame: Baseline, 2 week, 4 week, 8 week
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Zeynep Karakuş
Study officials:
affiliation: Akdeniz University
name: Zeynep Özer
role: STUDY_DIRECTOR
References:
Clinical trial NCT01633320: Non-invasive Assessment of Immediate Postoperative Analgesia Using Analgesia/Nociception Index (ANI)
Official title: Non-invasive Assessment of Immediate Postoperative Analgesia Using Analgesia/Nociception Index (ANI): A Prospective and Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Pain
Keywords: Analgesia/Nociception index
Lead sponsor: Hôpital Edouard Herriot
Sponsor class: OTHER
First posted: 2012-07-04
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients underoing surgical or endoscopic procedures performed on general anesthesia

Brief summary: The aim of this study is to evaluate the clinical performance on Analgesia/Nociception Index (ANI) in the assessment of immediate postoperative analgesia in PACU in adult patients undergoing general anesthesia.

Detailed description: Evaluation of the relationship between ANI and numerical rating pain scale (NRS) by linear regression.

Assessment of the performance of ANI to detect NRS\>3 and NRS\>=7 by building ROC curves.

Eligibility criteria: Inclusion Criteria:

* adult
* surgical or endoscopic procedures performed on general anesthesia

Exclusion Criteria:

* age \<18 yrs or \>75 yrs
* arrythmia
* administration of anticholinergic drugs or neuromuscular blockade reversal in the 20 previous minutes
* psychiatric diseases
* autonomic nervous system (ANS) disorders
* inability to understand the verbal rating pain scale.

Primary outcomes:
measure: Analgesia/Nociception Index (ANI)
timeFrame: At arrival in post-operative care unit (PACU) or 10 min after extubation
measure: Pain Scores on a 0-10 Numeric Rating Scale (NRS)
timeFrame: At arrival in PACU or 10 min after extubation
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Department of Anesthesiology and Intensive Care, Édouard Herriot hospital, HCL
Study officials:
affiliation: Édouard Herriot hospital, HCL
name: Lionel Bouvet, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Édouard Herriot hospital, HCL
name: Gérard Bégou, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Édouard Herriot hospital, HCL
name: Rabia Dabouz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Édouard Herriot hospital, HCL
name: Christophe Magnin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Édouard Herriot hospital, HCL
name: Bernard Allaouchiche, MD, PhD
role: STUDY_CHAIR
affiliation: Édouard Herriot hospital, HCL
name: Emmanuel Boselli, MD, PhD
role: STUDY_DIRECTOR
affiliation: Édouard Herriot hospital, HCL
name: Mirela-Daniela Ionescu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04833920: Effect tDCS of Motor Cortex on Chemotherapy Induced Peripheral Neuropathy
Official title: Effect of Motor Cortex Stimulation by Concentric Electrode Transcranial Direct Current Stimulation on Chemotherapy Induced Peripheral Neuropathy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chemotherapy-induced Peripheral Neuropathy
Keywords: brain stimulation
chemotherapy induced peripheral neuropathy
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-04-06
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Chemotherapy induced peripheral neuropathy (CIPN) occurs in conjunction with the use of anticancer medication such as vinca alkaloids (including vincristine), taxanes (including paclitaxel), and platinum preparations (including cisplatin and oxaliplatin)

Detailed description: Chemotherapy induced peripheral neuropathy (CIPN) occurs in conjunction with the use of anticancer medication such as vinca alkaloids (including vincristine), taxanes (including paclitaxel), and platinum preparations (including cisplatin and oxaliplatin) . CIPN is one of several long term side effects of anticancer medications that can appear during and after treatment. CIPN symptoms include pain, dysesthesia, motor and sensory disorders. CIPN can also be insufficiently responsive to pharmaceutical therapy similar to other types of refractory neuropathic pain This study is designed to evaluate the effect of two concentric electrode transcranial direct current stimulation (CE-tDCS) over the primary motor cortex (M) in management of chemotherapy induced peripheral neuropathy.

Eligibility criteria: Inclusion Criteria:

* any stage of cancer, with a confirmed treatment plan consisting of taxane-based or oxaliplatin-based chemotherapy, neuropathic pain and/or peripheral sensory neuropathy with VAS score ≥ 3 that are resistant to medical treatment

Exclusion Criteria:

* patients with intracranial metallic devices or with pacemakers or any other device. - -W those with extensive myocardial ischemia,
* higher brain dysfunction,
* migraine headache,
* brain cancer or metastasis and
* those known to have epilepsy

Primary outcomes:
measure: changes in the visual analogue scale
timeFrame: 0 (prestimulation), on the 5th day, 15th days and one month after the last session
Secondary outcomes:
measure: changes in the Leeds Assessment of neuropathic Symptoms and signs (LANSS)
timeFrame: 0 (prestimulation),on the 5th day, 15th days and one month after the last session
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: South Egypt Cancer Institute
Study officials:
affiliation: Assiut University
name: Shereen M Kamal, Associate Professor
role: PRINCIPAL_INVESTIGATOR
References: