louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT07002944: Pulsed Radiofrequency of Shoulder Individual Nerves Versus Brachial Plexus in Management of Chronic Post Mastectomy Shoulder Pain
Official title: Role of Pulsed Radiofrequency of Shoulder Individual Nerves Versus Brachial Plexus in Management of Chronic Post Mastectomy Shoulder Pain: A Prospective Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pulsed Radiofrequency
Shoulder Individual Nerves Brachial Plexus
Chronic
Post Mastectomy
Shoulder Pain
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-06-04
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: this study aims to assess the role of pulsed radiofrequency of the brachial plexus or pulsed radiofrequency of shoulder individual nerves in the management of post-mastectomy shoulder pain.

Detailed description: Breast cancer is the second most common cancer world-wide following lung cancer. It afflicts about 1.7 million patients annually, of which 60% mandate surgery of the breast and/or the axilla, and nearly 20-50% of them may develop post-mastectomy pain syndrome.

Regarding pulsed RF of the brachial plexus, it is not tried up till now for shoulder pain. Since C 5,6,7 are derived from upper and middle trunks of brachial plexus, then innervation of shoulder joint can be blocked by interscalene brachial plexus block or pulsed radiofrequency . Review of literature demonstrated efficacy of PRF of brachial plexus in case studies for other conditions e.g. pain associated with a tumor involving the brachial plexus , refractory stump pain , chemotherapy-induced peripheral neuropathy of the upper limb and radiation-induced brachial plexopathy .

Eligibility criteria: Inclusion Criteria:

* Age (18-65) Years.
* American Society of Anesthesiologists (ASA) physical status (II- III).
* Patients with post mastectomy shoulder pain.
* Body mass index (BMI): (20-40) kg/m2.
* Patients on maximum daily dose tramadol ( 450mg ) and still in pain

Exclusion Criteria:

* Patient refusal.
* Known sensitivity or contraindication to drugs used in the study.
* Pregnancy.
* Recent myocardial infarction.
* Hemodynamically unstable.
* Local and systemic sepsis.
* Psychiatric illness.

Primary outcomes:
measure: Changes in visual Analogue Scale (VAS )
timeFrame: 24 weeks post postoperatively
Secondary outcomes:
measure: Functional improvement
timeFrame: 24 weeks post postoperatively
measure: Analgesic consumption
timeFrame: 24 weeks post postoperatively
measure: Patient satisfaction
timeFrame: 24 weeks post postoperatively
measure: The impact of treatment on the quality of life of the patient
timeFrame: 24 weeks post postoperatively
measure: Incidence of complications
timeFrame: 24 weeks post postoperatively
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
References:
Clinical trial NCT03399344: Clinical Impact of Dedicated MR Staging of Ovarian Cancer
Official title: Clinical Impact of Dedicated MR Staging of Ovarian Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ovarian Cancer
Lead sponsor: The Netherlands Cancer Institute
Sponsor class: OTHER
First posted: 2018-01-16
Enrollment: 270
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patients will undergo an additional MRI, including a diffusion-weighted sequence, for assessing the extent of peritoneal carcinomatosis. Whether or not cytoreductive surgery is feasible will be scored using the peritoneal cancer index on diffusion-weighted magnetic resonance imaging
Primary purpose: DIAGNOSTIC

Brief summary: The only chance of cure for patients with advanced stage ovarian cancer is complete cytoreductive surgery (CRS). The only way to determine whether complete CRS can be achieved is by a laparoscopy. However, diffusion-weighted magnetic resonance imaging (DW-MRI) has a very high sensitivity to detect small volume malignant disease, making it a potentially suitable staging tool. Aim of this study is to determine the performance of DW-MRI for predicting whether complete CRS can be achieved.


Eligibility criteria: Inclusion Criteria:

* Patients with advanced stage (FIGO stage III or IV) ovarian cancer scheduled for primary or interval cytoreductive surgery
* Age \>18 years
* Written and signed informed consent
* WHO 0-2
* Able to read and write Dutch

Exclusion Criteria:

* Patients with contraindications for MRI
* Patients with contraindications for CRS
* Known additional malignancy

Primary outcomes:
measure: Diagnostic performance of DW-MRI to predict a complete cytoreductive surgery
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: NKI-AVL
Study officials:
References:
Clinical trial NCT05058144: Novel Alpha-Glucan Metabolism
Official title: Randomised, Placebo-controlled and Acute Study to Investigate the Metabolism of a Novel Alpha-Glucan in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2021-09-27
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 3X3
Primary purpose: OTHER

Brief summary: These are the characteristics of the project:

Monocentric:

Double blind randomized and crossover: you will test all the 3 products in random order.

Detailed description: This study will be randomized, double blind, placebo-controlled, single-center, and 3x3 crossover in design. Eligible participants will be randomized to receive the below products in single dose and in different random sequence, as determined by the randomization system

1. 50 g novel alpha glucan
2. 50 g (rapidly digestible control)
3. 15 g (dietary fiber)

Eligibility criteria: Inclusion Criteria:

Healthy status (based on anamnesis) Body mass index (BMI) between 18.5 and 29.9 kg/m2 Able to understand and sign informed consent form.

Exclusion Criteria:

1. Pregnant or lactating women
2. Type I and type 2 diabetes
3. Known food allergy or intolerance to test product
4. Major medical/surgical event in the last 3 months potentially interfering with study procedures and assessments
5. Abnormal bowel transit, history of a gastrointestinal disorder (e.g., inflammatory bowel disease, diverticular diseases, colon cancer), or history of chronic constipation with passage of fewer than 3 spontaneous bowel movements per week on average or chronic or recurrent diarrhea with spontaneous bowel movements more often than 3 times daily
6. Any concomitant medication potentially interfering with study procedures and assessment: such as antibiotics, antiacids, or other medications impacting transit time, colonoscopy, irrigoscopy or other bowel cleansing procedures four weeks prior the test
7. Recent episode of an acute gastrointestinal illness
8. Alcohol intake higher than 2 servings per day. A serving is 0.4 dl of strong alcohols, 1 dl of red or white wine, or 3 dl of beer.
9. Smokers
10. Volunteer who cannot be expected to comply with the protocol
11. Family or hierarchical relationships with Clinical Innovation Lab team

Primary outcomes:
measure: Glucose concentration post ingestion of a test product
timeFrame: 180 minutes
Secondary outcomes:
measure: insulin response post ingestion of a test product
timeFrame: 180 minutes
measure: intestinal hydrogen production as measured by breath hydrogen
timeFrame: 240 minutes
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Clinical Innovation Lab
Study officials:
References:
Clinical trial NCT06238544: Long-term Safety and Tolerability of HRS-5965 in Patients With Paroxysmal Nocturnal Hemoglobinuria
Official title: An Open Label, Multicenter Study to Evaluate the Long-term Safety and Tolerability of HRS-5965 in Patients With Paroxysmal Nocturnal Hemoglobinuria
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Paroxysmal Nocturnal Hemoglobinuria
Lead sponsor: Chengdu Suncadia Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-02-02
Enrollment: 120
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: This is a multicenter, single-arm, open-label study. Patients with Paroxysmal Nocturnal Hemoglobinuria who had previously received and completed the HRS-5965 study well included. All eligible subjects received HRS-5965 tablets or capsules until the end of treatment in this study.


Eligibility criteria: Inclusion Criteria:

1. Patients who have previously received and completed HRS-5965 study treatment, and are judged by the investigator to have treatment benefit and may benefit from continued treatment of HRS-5965 and patients in the control group of who received eculizumab treatment.

Exclusion Criteria:

1. Known or suspected hereditary or acquired complement deficiency;
2. History of infection with capsular bacteria (e.g., meningococcus, pneumococcus, etc.)

Primary outcomes:
measure: Incidence and severity of adverse events.
timeFrame: Every six months,for about 3 years
Secondary outcomes:
measure: Proportion of participants achieving sustained hemoglobin levels ≥ 12 g/dL in the absence of red blood cell transfusions was assessed every half a year during treatment..
timeFrame: Every six months ,for about 3 years
measure: Proportion of participants who remain free from transfusions was assessed every half a year during treatment..
timeFrame: Every six months,for about 3 years
measure: Rate of breakthrough hemolysis was assessed every half a year during treatment
timeFrame: Every six months,for about 3 years
measure: Proportion of participants with Major Adverse Vascular Events MAVEs.
timeFrame: Every six months,for about 3 years
measure: Plasma concentration of HRS-5965.
timeFrame: Start of Treatment to end of study，for about 3 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
state: Beijing
city: Tianjin
country: China
facility: The Blood Disease Hospital of the Chinese Academy of Medical Sciences
state: Tianjin
Study officials:
References:
Clinical trial NCT00811044: Regulation of Hepatic Insulin Extraction
Official title: Regulation of Hepatic Insulin Extraction:Alterations of Insulin Secretion in Subjects With Genetic Variants That Determine Risk for Non-Insulin Dependant Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Diabetes
Keywords: diabetes
genetics
oral glucose tolerance testing
family history of diabetes
gestational diabetes
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: University of Chicago
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2008-12-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy Volunteers \& otherwise healthy diabetic volunteers (do not require insulin for glucose control).

Brief summary: * This study is in the area of Type 2 diabetes and genetics
* Healthy Volunteers and those with mild type 2 diabetes may be eligible to participate
* This study is searching for genes that may affect the body's processing/digestion of glucose/sugar

Detailed description: This study is looking at the genetic influences of type 2 diabetes. It also is investigating the various gastric hormones including but not limited to: insulin, C-peptide, GIP, GLP, \& Xenin.

Eligibility criteria: Inclusion Criteria:

* ages 18-65
* non-diabetic
* diabetes controlled with diet or with pills
* no family history of diabetes
* family history of type 2 diabetes
* personal history of gestational diabetes

Exclusion Criteria:

* \< 18 or \> 65 years of age
* medications that affect glucose (sugar) levels
* kidney disease
* liver disease
* heart/cardiovascular disease

Primary outcomes:
measure: Genes affecting the development of Type 2 diabetes will be identified
timeFrame: 1 year
Secondary outcomes:
measure: Any differences between genetic groups in the metabolism of glucose/sugar will be studied to the extent that the data allow
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Washington University School of Medicine
name: Kenneth S Polonsky, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01373944: Efficiency and Outcomes of Stress-Only Anger and D-SPECT Stress-Only SPECT MPI
Official title: Rapid-Acquisition Low-Dosimetry Tc-99m Stress-Only Myocardial Perfusion SPECT on the Spectrum Dynamics System: Comparison of Efficiency and Outcomes With Stress-Only Anger SPECT
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Keywords: MPI
SPECT
Stress-Only
Spectrum Dynamics Camera
Anger
Lead sponsor: Aspire Foundation
Sponsor class: OTHER
Collaborators: name: Spectrum Dynamics
name: Cardiovascular Imaging Technologies, LLC
name: Saint Luke's Cardiovascular Consultants
name: Mid America Heart Institute
First posted: 2011-06-15
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients referred for clinically-indicated myocardial perfusion SPECT

Brief summary: The purpose of this study is to compare clinical efficiency and patient outcomes using ultra low-dose stress only Tc-99m and solid-state SPECT versus traditional Anger SPECT.


Eligibility criteria: Inclusion Criteria:

* BMI \< 35 kg/m2
* LVEF \> 40%
* Exercise stress
* Elective out-patients
* No known CAD (\>50%) by catheterization
* No history of prior myocardial infarction

Exclusion Criteria:

* LBBB
* Pacemaker
* Atrial Fibrillation
* Frequent PAC's or PVC's
* Inability to achieve at least 6 minutes

Primary outcomes:
measure: Diagnostic Failure
timeFrame: 30 days
Secondary outcomes:
measure: Necessity to proceed to a rest image
timeFrame: 30 days
measure: Necessity for additional downstream testing
timeFrame: 30 days
measure: Coronary Angiography
timeFrame: 60 to 90 days
measure: Determine optimal performance of the Spectrum Dynamics camera system for stress only imaging
timeFrame: 60 to 90 days
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Saint Luke's Cardiovascular Imaging Center
state: Missouri
city: Kansas City
country: United States
facility: Saint Luke's North Cardiovascular Imaging Center
state: Missouri
city: Lee's Summit
country: United States
facility: Saint Luke's East Cardiovascular Imaging Center
state: Missouri
Study officials:
affiliation: Aspire Foundation
name: Timothy M Bateman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05420844: Pilot Study to Evaluate a Voice Journaling Application in Adolescents With Cystic Fibrosis
Official title: Pilot Study to Evaluate the Feasibility and Acceptability of a Voice Journaling Application in Adolescents With Cystic Fibrosis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cystic Fibrosis
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2022-06-15
Enrollment: 30
Sex: ALL
Minimum age (years): 14
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The overall goal of this pilot study is to evaluate the feasibility and acceptability of the Kintsugi voice journaling app in adolescents with CF to inform the design of future observational and interventional trials. Additionally, the investigators aim to evaluate the potential impact of the voice journaling app on key clinical outcomes in CF.


Eligibility criteria: Inclusion Criteria:

1. Diagnosis of cystic fibrosis based on sweat chloride (≥60) or two known disease-causing mutations
2. Age 14 - 18 years
3. History of elevated GAD-7 and/or PHQ-9 on screening questionnaires completed during routine CF clinical visits within the past year
4. Clinically stable at the time of enrollment, without increased respiratory and/or GI symptoms or treatment with IV and/or oral antibiotics for an acute illness for the 14 days prior to enrollment visit. Participants receiving inhaled antibiotics every other month are eligible to enroll. Participants receiving chronic oral antibiotics, including thrice weekly azithromycin will be eligible to participate
5. Access to an iOS device (iPhone or iPad) and internet/data plan
6. Parent/participant enrolled in MyChart
7. Willing to participate in study after informed consent and assent has been obtained
8. English speaking

Exclusion Criteria:

1. Endorsement of suicidal ideation on the baseline PHQ-9 (item 9) questionnaire at the enrollment visit
2. Developmental or cognitive delay preventing participant from interacting with voice journaling app
3. Unable to speak and write proficiently in English
4. Enrollment in another behavioral health study
5. Actively in treatment with a mental health provider

Primary outcomes:
measure: Kintsugi Usage
timeFrame: 3 Months
measure: Kintsugi Satisfaction
timeFrame: 3 Months
Secondary outcomes:
measure: Change in GAD-7 (Generalized Anxiety Disorder-7) Scores
timeFrame: 3 Months
measure: Change in PHQ-9 (Patient Health Questionnaire-9) Scores
timeFrame: 3 Months
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
Study officials:
affiliation: Children's Hospital Colorado
name: Jordana Hoppe, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04464044: Clinical Performance of a Daily Disposable Toric Silicone Hydrogel Contact Lens
Official title: Clinical Performance of a Daily Disposable Toric Silicone Hydrogel Contact Lens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Astigmatism
Keywords: Toric contact lens
Daily disposable
Silicone hydrogel contact lens
Axis orientation
Astigmatism
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2020-07-09
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The purpose of this study is to obtain on-eye clinical performance data to evaluate the stability of axis orientation of DDT2 toric contact lenses in the intended population.

Detailed description: This is a single-visit, non-dispense study where subjects will be exposed to the test lenses for approximately 1 hour.

Eligibility criteria: Inclusion Criteria:

* Able to understand and sign an informed consent form;
* Successful wear of spherical or toric soft contact lenses in both eyes, as specified in the protocol;
* Willing to NOT use rewetting/lubricating drops at any time during the study;
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Any eye condition that would contraindicate contact lens wear, as determined by the Investigator;
* History of eye surgery within the previous 12 months, as specified in the protocol;
* Current or history of dry eye in either eye that, in the opinion of the Investigator, would preclude contact lens wear;
* Other protocol-specified exclusion criteria may apply.

Primary outcomes:
measure: Percent of lenses with axis orientation within ±30° from the intended axis, 10 minutes after lens insertion
timeFrame: Day 1, 10 minutes after lens insertion
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Contact Alcon Call Center for Trial Locations
state: Texas
Study officials:
affiliation: Alcon Research, LLC
name: Clinical Trial Lead, Vision Care
role: STUDY_DIRECTOR
References:
Clinical trial NCT06910644: Dexmedetomidine Versus Lidocaine Infusions as Adjuvants to General Anesthesia for Chronic Pain Management After Mastectomy
Official title: Dexmedetomidine Versus Lidocaine Infusions as Adjuvants to General Anesthesia for Chronic Pain Management After Mastectomy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dexmedetomidine
Lidocaine
Infusion
Adjuvants
General Anesthesia
Chronic Pain
Mastectomy
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-04-04
Enrollment: 90
Sex: FEMALE
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: This study aims to compare dexmedetomidine and lidocaine infusions as adjuvants to general anesthesia for chronic pain management after mastectomy.

Detailed description: Chronic pain after breast cancer surgery is a significant problem that is expected to become more relevant because the number of patients undergoing breast cancer surgery is increasing owing to the longer survival associated with this surgery.

Lidocaine is the local anesthetic, which is used more often, and it is considered the prototype of amino-amide local anesthetics. Dexmedetomidine (DEX) is a highly selective agonist that acts by binding with presynaptic alpha 2-adrenergic receptor and then activating the negative feedback loop of the sympathetic nerve response, leading to inhibited norepinephrine release from the sympathetic terminals and decreased reflex activity of the sympathetic nervous.

Eligibility criteria: Inclusion Criteria:

* Age from 18 to 75 years.
* American Society of Anesthesiologists (ASA) physical status II.
* Scheduled for mastectomy with axillary dissection (either modified radical mastectomy with or without latissimus dorsi flap or conservative breast surgery) due to breast cancer.

Exclusion Criteria:

* Patient refusal.
* Known allergy to any of the study drugs.
* Those with hepatic or renal insufficiency.
* Patients who are running regularly on B blockers.
* α2 adrenergic agonists and sedatives.
* Psychoactive medications.

Primary outcomes:
measure: Incidence of the chronic pain
timeFrame: 6 months postoperatively
Secondary outcomes:
measure: Time to the 1st rescue analgesia
timeFrame: 48 hours postoperatively
measure: Heart rate
timeFrame: Till the end of operation (Up to 2 hours)
measure: Mean arterial pressure
timeFrame: Till the end of operation (Up to 2 hours)
measure: Total morphine consumption
timeFrame: 48 hours postoperatively
measure: Degree of pain
timeFrame: 12 weeks postoperatively
measure: Incidence of post-mastectomy pain syndrome
timeFrame: 6 months postoperatively
measure: Activity level
timeFrame: 12 weeks postoperatively
measure: Assessment of quality of life
timeFrame: 12 weeks postoperatively
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
References: