louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06522503: Effect of Stress Ball on Perceived Stress, Pain and Satisfaction in Cancer Patients
Official title: The Effect of a Stress Ball on Perceived Stress, Pain and Satisfaction in Cancer Patients: A Distraction-Based Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: cancer patient
perceived stress
pain
patient satisfaction
Lead sponsor: Izmir Bakircay University
Sponsor class: OTHER
First posted: 2024-07-26
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled experimental study
Primary purpose: SUPPORTIVE_CARE

Brief summary: The objective of this study was to ascertain the impact of stress ball utilisation on perceived stress, pain and satisfaction levels during port catheter intervention in cancer patients. In this study, which was conducted in a randomised controlled design, a control group of cancer patients receiving chemotherapy (n=37) was assigned to receive standard care during port catheter needle insertion. An intervention group (n=37) was also formed, comprising patients who received stress ball application in addition to standard care. The intervention group was provided with a stress ball in both hands five minutes prior to the insertion of the port catheter needle and instructed to squeeze the ball in their hands at regular intervals until the conclusion of the procedure. Prior to the application, the descriptive characteristics of both groups were ascertained, and their perceived stress levels were assessed. Subsequently, the pain and perceived stress levels of both groups were documented. Additionally, the satisfaction levels of the intervention group regarding the stress ball application were evaluated.


Eligibility criteria: Inclusion Criteria:

* 18 years and older
* Diagnosed with cancer
* Undergoing active chemotherapy
* Willing to participate in the research .

Exclusion Criteria:

* Communication difficulties
* Complaints of peripheral neuropathy
* Refusal to participate in the research

Primary outcomes:
measure: perceived stress level
timeFrame: baseline and end of the port catheterisation procedure (mean time 10 minutes)
Secondary outcomes:
measure: pain level
timeFrame: End of the port catheterisation procedure (mean time 10 minutes)
Other outcomes:
measure: patient satisfaction level
timeFrame: End of the port catheterisation procedure (mean time 10 minutes)
Locations:
city: Izmir
country: Turkey
facility: Ayşegül Çelik
state: Menemen
Study officials:
affiliation: Izmir Bakircay University
name: Aslıhan Öztürk Çetin, MSc
role: STUDY_CHAIR
References:
Clinical trial NCT00844103: Study to Investigate the Safety, Tolerability and Pharmacokinetics of Multiple Doses of AZD8566.
Official title: A Phase I, Randomised, Double Blind, Placebo-Controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of Multiple Oral Doses of AZD8566 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pharmacokinetics
Keywords: Volunteer
Safety
Tolerability
AZD8566
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-02-13
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine how well tolerated and safe AZD8566 is when given over 10 days, at different dose levels. This study will also determine how AZD8566 is distributed around the body and how it leaves the body.


Eligibility criteria: Inclusion Criteria:

* Provision of written informed consent.
* Clinically normal physical findings and laboratory values as judged by the investigator with normal ECG
* Females who are permanently or surgically sterile or postmenopausal and males.

Exclusion Criteria:

* Intake of medicine (except Hormone Replacement Therapy or occasional paracetamol) within 3 weeks before first administration of study drug
* History of any convulsions or seizures
* History of infection or at risk of infection due to recent surgery or trauma
* History or presence of conditions known to interfere with the absorption, distribution, metabolism and excretion of the study drug

Primary outcomes:
measure: Pharmacokinetic profile: concentration of AZD8566 in blood
timeFrame: Samples taken during Visit 2 (residential period) at up to 15 defined timepoints pre-dose and post- dose on Day 1 and Day 10
measure: Safety and tolerability of AZD8566 by assessment of vital signs, laboratory variables, ECG and adverse events
timeFrame: Assessments taken at Visit 1 (enrolment), defined timepoints pre-dose and post-dose during Visit 2 (residential period) and at Visit 3 (follow up). Volunteers will be monitored throughout the study from Visit 1 to Visit 3 for adverse events.
Secondary outcomes:
measure: Pharmacokinetic profile: concentration of AZD8566 in urine
timeFrame: Samples collected over 48 hours from pre-dose to 48 hours post-dose on Day 1 and Day 10.
Other outcomes:
Locations:
city: Macclesfield
country: United Kingdom
facility: Research Site
state: Cheshire
Study officials:
affiliation: Clinical Pharmacology Unit
name: Emeline Ramos, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01020903: Aprepitant for Post-operative Nausea
Official title: Aprepitant vs. Placebo for the Prevention of Postoperative Nausea and Vomiting: a Randomized, Double-blind Study in Patients Undergoing Laparoscopic Cholecystectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Nausea
Lead sponsor: Northwell Health
Sponsor class: OTHER
Collaborators: name: Staten Island University Hospital
First posted: 2009-11-26
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Anesthesia, especially for laparoscopic surgery, can cause post-operative nausea and vomiting. Most patients are given two drugs, decadron and ondansetron, to try to minimize this. This study is to determine if a new drug, aprepitant, would add any benefit in terms of post-op nausea prevention. All laparoscopic cholecystectomy study patients will receive decadron and ondansetron. Half the patients will receive aprepitant in addition. The other half will receive placebo. The study will be randomized and double-blind.


Eligibility criteria: Inclusion Criteria:

* Laparoscopic cholecystectomy patients.
* Must be able to swallow a pill.

Exclusion Criteria:

* Liver failure,
* Age less than 18.
* Pregnancy, breast-feeding.
* Pre-op vomiting.
* Allergy to aprepitant.
* Need for post-op gastric drainage.
* Use of drugs that interact with aprepitant.

Primary outcomes:
measure: Post-operative Nausea and Vomiting
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Staten Island
country: United States
facility: Staten Island University Hospital
state: New York
Study officials:
affiliation: Staten Island University Hospital
name: Michael B Silverberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Diemunsch P, Schoeffler P, Bryssine B, Cheli-Muller LE, Lees J, McQuade BA, Spraggs CF. Antiemetic activity of the NK1 receptor antagonist GR205171 in the treatment of established postoperative nausea and vomiting after major gynaecological surgery. Br J Anaesth. 1999 Feb;82(2):274-6. doi: 10.1093/bja/82.2.274.
Clinical trial NCT03390803: Effect of Hemifacial Spasm on Intraocular Pressure Measurement
Official title: Effect of Hemifacial Spasm on Intraocular Pressure Measurement
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemifacial Spasm
Intraocular Pressure
Lead sponsor: Medipol University
Sponsor class: OTHER
First posted: 2018-01-04
Enrollment: 49
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Twenty-four consecutive patients with Hemifacial spasm (study group) and twenty-five age-matched and gender-matched healthy volunteers (control group) will be prospectively included in the study. Intraocular pressure measurements will be performed before and 2 weeks after Botox injections in patients with HFS (involved and uninvolved eyes of HFS both) and in healthy volunteers without Botox injections.

Brief summary: Twenty-four consecutive patients with Hemifacial spasm and 25 age and gender-matched randomly selected eyes of healthy volunteers underwent corneal pachymetry and intraocular pressure measurements using Goldmann Applanation Tonometer and non-contact tonometer. An interval of 15 minutes was maintained between Goldmann Applanation Tonometer and non-contact tonometer measurements. Intraocular pressure measurements were performed before (during hemifacial spasm) and 2 weeks after Botox injections in Hemifacial spasm patients and in healthy volunteers without Botox injections. All the measurements with Goldmann Applanation Tonometer were carried out by a single physician while those with the non-contact tonometer were done by another physician who was masked to the results of the Goldmann Applanation Tonometer. All measurements were taken between 10:00 and 11:00 a.m.


Eligibility criteria: Inclusion Criteria:

* patients with hemifacial spasm

Exclusion Criteria:

* Subjects will be excluded if they have allergies to botulinum toxin or any component of the drug, previous eyelid, refractive or intraocular surgery, any abnormality preventing reliable tonometry in either eye, strabismus, contact lens wear, pregnancy, glaucoma, ocular hypertension and patients using agents that could interfere with neuromuscular transmission.

Primary outcomes:
measure: Effect of Hemifacial Spasm on Intraocular Pressure Measurement Change
timeFrame: 2 week
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Cicik E, Yildirim R, Arici C, Dikkaya F, Arslan OS. Effect of Hemifacial Spasm on Intraocular Pressure Measurement. J Ophthalmol. 2018 Feb 6;2018:3621215. doi: 10.1155/2018/3621215. eCollection 2018.
Clinical trial NCT00675103: Re-exposure Study of Pegloticase Intravenous (i.v.) in Symptomatic Gout Patients
Official title: Multicenter, Open-Label, 24 Week Regimen of 8 mg Pegloticase i.v. in Symptomatic Gout Subjects Who Participated in Previous Studies of Pegloticase i.v.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Gout Refractory to Conventional Therapy
Keywords: Gout
Gouty Arthritis
Anti-Gout preparations
Lead sponsor: Savient Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2008-05-08
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the safety and clinical effect of re-exposure to a 24 week course of treatment of pegloticase i.v. in subjects whose last exposure to pegloticase i.v. was at least one year before study entry.

This study is limited to four study centers in the US.


Eligibility criteria: Inclusion Criteria:

* Previous treatment in studies of pegloticase i.v.
* Last exposure to pegloticase i.v. greater than one year prior to study entry
* Symptomatic gout
* Documented hyperuricemic (SUA ≥ 7 mg/dL)

Exclusion Criteria:

* Prior exposure to Elitek® (rasburicase)
* Unstable angina
* Uncontrolled arrhythmia or hypertension
* Non-compensated congestive heart failure
* End stage renal disease requiring dialysis
* Concomitant use of SUA lowering agents and use of other investigational drugs

Primary outcomes:
measure: Adverse Event Profile
timeFrame: 6 months
Secondary outcomes:
measure: Mean Plasma Uric Acid
timeFrame: Baseline, Week 3 and Week 7
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago- Dept. Biological Services
state: Illinois
city: Wheaton
country: United States
facility: The Center for Rheumatology and Bone Research
state: Maryland
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Lake Oswego
country: United States
facility: Portland Rheumatology Clinic, L.L.C.
state: Oregon
Study officials:
References:
Clinical trial NCT04905303: Solitaire Aneurysm Remodeling Registry
Official title: Prospective Multi-center, Single-arm Registry to Evaluate the Efficacy of the Solitaire AB Neurovascular Remodeling Device in the Treatment of Wide-neck Intracranial Aneurysms
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Intracranial Saccular Aneurysm, Either Rupture or Unruptured
Wide Neck Aneurysm
Keywords: Intracranial aneurysms
Wide neck aneurysms
Lead sponsor: Medtronic Neurovascular Clinical Affairs
Sponsor class: INDUSTRY
First posted: 2021-05-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with confirmed diagnosis of intracranial saccular aneurysm which can be treated with coil embolization and neurovascular stenting.

Brief summary: The objective of the registry is to evaluate the effectiveness and performance of the Solitaire Neurovascular Remodeling Device when used with embolic coils in the treatment of intracranial aneurysms.


Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of intracranial saccular aneurysms, either ruptured or unruptured
* Aneurysm requires current treatment with coils and a stent or aneurysm hs been previously treated with coils, but no prior placement of a stent.
* Aneurysm has a wide neck defined as having a neck equal to or greater than 4mm or a dome-to-neck ratio of \<2.
* Patient is 18 years or older.
* Patient has a Hunt \& Hess score of III or less.

Exclusion Criteria:

* Patient has a fusiform or dissecting aneurysm type.
* Patient is contraindicated for either heparin or anti-platelet therapy.
* Patient has severe allergy to IV contrast medium.
* Patient has a known hypersensitivity to nickel-titanium.

Primary outcomes:
measure: Stable Stent placement with complete coverage across the aneurysm neck with parent artery patency
timeFrame: Six months post-implant
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hopital Neurologique
Study officials:
References:
Clinical trial NCT01855503: Breast Cancer Molecular Analysis Protocol
Official title: Breast Cancer Molecular Analysis Prior to Investigational Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Breast Cancer
Keywords: Metastatic
Breast Cancer
Metastatic Breast Cancer
Breast
Biopsy
Molecular
Genetic
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Foundation Medicine
First posted: 2013-05-16
Enrollment: 121
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Metastatic Breast Cancer

Brief summary: This is a molecular testing study for patients with metastatic breast cancer. The purpose of this study is to find defects in the DNA of the cancer that could potentially be treated with US Food and Drug Administration (FDA)approved or investigational drugs. For example, if your cancer has a mutation in the Epidermal Growth Factor Receptor (EGFR) gene (a mutation is a change int he DNA sequence of a gene) that makes this receptor "superactive" a drug that inhibits this receptor may also inhibit the growth of the cancer. If this genetic defect is not present in the cancer the same drug may not work. This EGFR gene mutation based patient selection for treatment has worked in lung cancer and we are testing its value in breast cancer. What drugs may be available against particular genetic abnormalities in the context of this clinical study will change over time.


Eligibility criteria: Inclusion Criteria:

1. All patients with metastatic breast cancer who are considered for further systemic therapy are eligible regardless of number of prior therapies.
2. Patient must have a metastatic lesion that could be safely biopsied with or without image-guidance. The final arbiter to decide what lesion can be biopsied is the physician who will perform the biopsy.
3. There is no age limit for this study. However, this study will not include children because metastatic breast cancer does not occur in children.
4. Patients may participate in the biopsy study multiple times to repeat molecular assessment of the cancer after progression.
5. Patients who undergo routine clinical biopsy of metastatic breast cancer are also eligible to participate in this study. When the routine biopsies are obtained for diagnostic or other purposes, additional biopsies will be taken during the same biopsy session for molecular analysis.

Exclusion Criteria:

1. Known medical contraindication for needle biopsy procedure such as bleeding disorder, low platelet count, inability to provide informed consent

Primary outcomes:
measure: molecular analysis of metastatic breast cancer using DNA sequencing
timeFrame: 2 years
Secondary outcomes:
measure: To establish a metastatic breast cancer tissues resource for future research
timeFrame: 2 years
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Smilow Hospital Breast Center
state: Connecticut
Study officials:
affiliation: Yale University
name: Lajos Pusztai, M.D., D.Phil
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03685903: Study for the Detection of Duodenal Papilla Using Capsule Endoscopy and Comparison of Images With EUS/ERCP Procedure.
Official title: Prospective Observational Study for the Detection of Duodenal Papilla Using Capsule Endoscopy and Comparison of Images With EUS/ERCP Procedure in Pancreaticobiliary and Periampullary Pathology
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Patients Indicated for Periampullary or Pancreaticobiliary Examination
Lead sponsor: Capso Vision, Inc.
Sponsor class: INDUSTRY
First posted: 2018-09-26
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: This observational Non-Significant Risk (NSR) Study will be used to assess the ability of CapsoCam® Plus (SV-3) capsule endoscope to detect the duodenal papilla and visualize pathology or abnormalities in the periampullary area and will prospectively compare the capsule endoscopy and EUS/ERCP pictorial images acquired in procedures conducted in a minimum of 20 and a maximum of 200 research patients.


Eligibility criteria: Inclusion Criteria:

* Males or females at least 18 years of age.
* Provided written HIPAA Informed Consent in the IRB approved language.
* Patients indicated for periampullary or pancreaticobiliary examination, with prior cross-sectional imaging (CT/MRI/US/other) performed within past 6 months.

Exclusion Criteria:

* Patients with existing biliary stent will be excluded
* EUS/ERCP exclusion criteria: per medical practice, including:

  1. Patient refusal to undergo procedure, unstable cardiopulmonary, neurologic, or cardiovascular status; existing bowel perforation
  2. Structural abnormalities of esophagus, stomach, small intestine at the discretion of physician.
* Capsule Endoscopy (CE) exclusion criteria:

  1. CE exclusion criteria: difficulty swallowing, pregnancy, known motility issues (gastroparesis), known strictures, gastrointestinal obstructions, fistula or significantly distorted anatomy.
  2. Medical history of receipt of surgery, oncologic therapy, or radiation therapy who, in the opinion of the investigator, are at greater risk of capsule endoscope retention.
  3. Any other contra-indicated condition as noted on the CapsoCam® Plus (SV-3) Instructions for Use, package insert.

Primary outcomes:
measure: The ability to detect and visualize the duodenal papilla
timeFrame: during capsule endoscopy procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
References:
Clinical trial NCT04666103: Function Integrity of Neck Anatomy in Thyroid Surgery
Official title: Preserving Function Integrity of Neck Anatomy in Thyroid Surgery: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Thyroid Carcinoma
Thyroid Nodule (Benign)
Ablation; Retina
Lead sponsor: Wuhan University
Sponsor class: OTHER
First posted: 2020-12-14
Enrollment: 1264
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: Recent trends in the management of patients with low-risk papillary thyroid carcinoma who have a nonsuspicious or cytologically benign contralateral nodule call into question the need for routine total thyroidectomy. Although the lobectomy for the unilateral thyroid cancer with contralateral benign nodules is sufficient treatment, some of the patients might suffer from the anxiety of the residual benign thyroid nodule and tend to choose total thyroidectomy, which might be overtreatment.

Thermal ablation has been proven to be effective in achieving nodule shrinkage and being also free from major complications. In our institution, intraoperative RFA was a proposed alternative strategy to treat the contralateral benign nodules after the thyroid lobectomy for the malignant lobe, which was found to have a better quality of life on anxiety, physiological health, social family, psychological and sensory mentions with a considerable complication rate.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with unilateral thyroid carcinoma and contralateral benign nodule confirmed by preoperative ultrasound-guided fine-needle aspiration cytology;
* Patients with contralateral nodules ≤ 20mm and located in the thyroid gland;
* Patients with clinical node-negative cervical compartment at palpation and neck ultrasound.

Exclusion Criteria:

* Previous history of neck surgery
* Previous history of neck radiation therapy

Primary outcomes:
measure: Rate of complications
timeFrame: Up to 2 years
measure: Scores of hospital anxiety and depression scale (HADS)
timeFrame: Up to 6 months
measure: Scores of fear of progression questionnaire-short form(FPQS)
timeFrame: Up to 6 months
measure: Scores of thyroid cancer- specific quality of life (THYCA-QoL) questionnaire
timeFrame: Up to 6 months
measure: Rate of recurrence
timeFrame: 5-year estimate reported after a median follow-up of 60 months
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Zhongnan Hospital of Wuhan University
state: Hubei
Study officials:
affiliation: Department of Breast and Thyroid Surgery, Zhongnan Hospital of Wuhan University
name: Gaosong Wu, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: