louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06434233: Opioid Use After Laparoscopic Salpingectomy
Official title: A Randomized Control Trial for Opioid Use After Laparoscopic Salpingectomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Opioid Use
Post-operative Pain
Sterility, Female
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2024-05-30
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to evaluate patient-reported post-operative pain scores following minimally invasive tubal sterilization procedures to determine if a multimodal, non-opioid pain control regimen is non-inferior to a pain control regimen including opioids.

The study team hypothesizes that with extensive counseling on pain management, multimodal medication use, and expectation with non-opioid methods can effectively eliminate the need for opioid prescriptions after laparoscopic salpingectomy.


Eligibility criteria: Inclusion Criteria:

* Individuals with a fallopian tube (unilateral and/or bilateral)
* Age 18 years old and above
* Undergoing minimally invasive (laparoscopic or robotic) unilateral or bilateral salpingectomy or other tubal sterilization procedure as the primary procedure
* Benign indications for salpingectomy/tubal sterilization
* Agreeing to participate

Exclusion Criteria:

* Chronic pain syndromes patients including fibromyalgia
* Patients currently on long-term (i.e. for more than three months) opioid use
* Conversion to laparotomy
* Allergy or other contraindication to the prescribed medications such as acetaminophen or oxycodone
* Salpingectomy that occurs in conjunction with a major Gyn surgery (i.e. hysterectomy, etc)
* Salpingectomy performed for treatment of ectopic pregnancy
* Patients with a history of gastritis and/or GI bleeding

Primary outcomes:
measure: Numeric post-operative pain score
timeFrame: post-operative day 1 and post-operative day 7
Secondary outcomes:
measure: Satisfaction with post-operative pain relief
timeFrame: post-operative day 1 and post-operative day 7
measure: Satisfaction with post-operative mobility
timeFrame: post-operative day 1 and post-operative day 7
measure: Total narcotic consumption at one week post-operative
timeFrame: post-operative day 7
measure: Occurrence of defined opioid related side effects (N/V, constipation, dizziness, itchiness)
timeFrame: post-operative day 1 and post-operative day 7
measure: Suboptimal pain control as assessed by the number of patients requesting additional medication or seeking unplanned medical care for a post-surgical pain-related concern
timeFrame: Within 30 days of surgery
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Bayview Medical Center
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Mostafa Borahay, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06907433: Kinesiotaping and Rigid Taping in Sacroiliac Joint Dysfunction
Official title: Evaluation of the Effects of Rigid Taping and Kinesiotaping on Pain, Joint Mobility and Disability in Patients with Sacroiliac Joint Dysfunction: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Lead sponsor: Ufuk University
Sponsor class: OTHER
First posted: 2025-04-02
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objective: To evaluate the effects of rigid-taping and kinesiotaping (lymphatic correction) on pain, joint mobility and disability in patients with sacroiliac joint dysfunction (SIJD).

Methods: A total of 84 patients with unilateral SJID were included in this randomized controlled study. Patients were divided into kinesiotaping (KT) (n=28), rigid-taping (RT) (n=28) and control (n=28) groups. Pain levels at rest and during movement with visual analog scale (VAS) (0-10 cm), Oswestry Disability Index (ODI), mobility and pain provocation tests were recorded on days 1 and 15.


Eligibility criteria: Inclusion Criteria:

* patients aged 18-50 years
* patients who had subacute and chronic (lasting longer than 1 month), mechanical type low back and/or hip pain thought to be due to unilateral SIJD (spreading between 3 cm above and 10 cm below the posterior superior iliac spine, not extending above the 5th lumbar vertebra)
* patients who had at least 3 positive results out of 6 pain provocation tests for the sacroiliac joint.

Exclusion Criteria:

* the presence of known infectious, inflammatory, tumoral and advanced degenerative diseases that may cause low back pain, pain referred from abdominal or pelvic organs, history of spine or hip fracture/surgery,
* presence of nerve root involvement findings,
* presence of pregnancy, presence of inflammatory pathology in routine blood tests seen at the examination application
* presence of inflammatory or advanced degenerative changes in the sacroiliac joint in imaging methods,
* presence of findings suggesting bilateral sacroiliac joint dysfunction.

Primary outcomes:
measure: pain intensity with movement and at rest on a 0-10 cm visual analog scale (VAS) scale (0=no pain, 10=unbearable pain)
timeFrame: 15 days
measure: Oswestry Disability Index
timeFrame: 15 days
Secondary outcomes:
measure: The number of positive mobility test
timeFrame: 15 days
measure: The number of positive pain provacation test
timeFrame: 15 days
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ufuk University
Study officials:
References:
Clinical trial NCT00736333: A Study to Evaluate Safety and Tolerability in Patients With Metastatic Breast Cancer Receiving Treatment With Caelyx (Study P04878)(COMPLETED)
Official title: Observational Program of Caelyx in MBC - Prevention and Treatment of PPE and Infusion Reactions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Neoplasm
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-08-15
Enrollment: 167
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with metastatic breast cancer

Brief summary: This is a study to evaluate the safety and tolerability of Caelyx used for the treatment of metastatic breast cancer (MBC), focusing on infusion reaction and palmar-plantar erythrodysesthesia (PPE).

Detailed description: Patients selected by investigator according to clinical routine

Eligibility criteria: Inclusion Criteria:

* Patients with metastatic breast cancer

Exclusion Criteria:

* History of hypersensitivity to Caelyx or its components
* Women who are pregnant or breast-feeding
* Patients with severe myelosuppression

Primary outcomes:
measure: Number of Participants With Infusion Reactions (IR)
timeFrame: Day 1 up to Week 24
measure: Percent of Participants Taking Premedication for Prevention of IR
timeFrame: Day 1, immediately prior to receiving first dose of pegylated liposomal doxorubicin
measure: Number of Participants With Pre-existing Allergic Conditions Who Experienced an IR
timeFrame: Cycles 1 & 3 (Week 4 & Week 12)
measure: Number of Occurrences of Palmar-plantar Erythrodysesthesia (PPE)
timeFrame: Up to 24 weeks
measure: Number of Times Premedications Were Given for Prevention of PPE
timeFrame: Day 1 up to 24 weeks
Secondary outcomes:
measure: Number of Participants With Complete Response (CR) or Partial Response (PR)
timeFrame: Day 1 up to 24 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00198133: Phase II Study of Alimta (Pemetrexed) Treatment of Advanced Thymoma and Thymic Carcinoma
Official title: Phase II Study of Alimta (Pemetrexed) Treatment of Advanced Thymoma and Thymic Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Thymoma
Thymic Carcinoma
Keywords: Thymoma
Thymic Carcinoma
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 27
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: To study the efficacy of Alimta as a single agent in thymic cancers

Detailed description: The broad range of clinical activity of thymic carcinomas makes the likelihood of detecting efficacy of a single agent such as premetrexed a reasonable objective since these malignancies are relatively slow growing and exhibit a broad range of chemosensitivity to antineoplastic agents.

Eligibility criteria: Inclusion Criteria:

* Histologically confirmed invasive, recurrent or metastatic thymoma or thymic carcinoma not amenable to potentially curative therapy by surgery. Original biopsy of tumor is sufficient for diagnoses unless otherwise clinically indicated.
* Patients must have measurable disease with at least one bidimensional measurable lesion. Any scans or x-rays used to document measurable disease must be obtained with 6 weeks prior to registration.
* Patients may have had prior chemotherapy for metastatic disease
* Adequate organ function as defined by: bili \</=1.5; calc. crt clr of \>/=45; hematologic-granulocytes \>/=1500 \& plt \>/=100K.
* Patients who are receiving a stable dose of corticosteroids for myasthenia gravis are eligible.
* ECOG performance status of 0 or 1

Exclusion Criteria:

* Acute intercurrent infection or complications
* pregnancy or lactating patients
* Inability to interrupt aspirin or other nonsteroidal anti-inflammatory agents for a 5-day period (8-day period for long-acting agents.
* Presence of clinically relevant third-space fluid collections that cannot be controlled by a procedure

Primary outcomes:
measure: Objective Response Rate (Complete and Partial Response)
timeFrame: Up to 3 years
Secondary outcomes:
measure: Duration of Remission
timeFrame: Time from the date of remission until progression or death, assessed up to 3 years
measure: Grade 3/4 Treatment Related Adverse Events
timeFrame: Up to 3 years
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Cancer Center
state: Indiana
Study officials:
affiliation: Indiana University
name: Patrick Loehrer, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gbolahan OB, Porter RF, Salter JT, Yiannoutsos C, Burns M, Chiorean EG, Loehrer PJ Sr. A Phase II Study of Pemetrexed in Patients with Recurrent Thymoma and Thymic Carcinoma. J Thorac Oncol. 2018 Dec;13(12):1940-1948. doi: 10.1016/j.jtho.2018.07.094. Epub 2018 Aug 16.
Clinical trial NCT05941533: Infrared Thermal Imaging in Evaluating the Percutaneous Transluminal Angioplasty for Peripheral Artery Disease
Official title: Infrared Thermal Imaging in Evaluating the Percutaneous Transluminal Angioplasty for Peripheral Artery Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Peripheral Artery Disease (PAD)
Keywords: peripheral artery disease (PAD), infrared thermal imaging (IRTI), percutaneous transluminal angioplasty (PTA)
Lead sponsor: The First Affiliated Hospital of Guangzhou Medical University
Sponsor class: OTHER
First posted: 2023-07-12
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: PAD patients who came to our hospital for diagnosis and treatment were initially selected, and those who met the indications for PTA surgery were finally included in the study.

Brief summary: Determination of IRTI (infrared thermal imaging) can be used to evaluate PAD patients with critical limb ischemia with different degrees of lesion.

IRTI can be used to evaluate the foot blood perfusion after percutaneous transluminal angioplasty (PTA) treatment and determine the success rate of surgery.

IRTI can be used as an effective follow-up tool for patients after surgery.


Eligibility criteria: Inclusion Criteria:

* Patients with Rutherford grade 3, 4, 5, or 6.
* Patients with indications for lower extremity arterial PTA: severe intermittent claudication, rest pain, ulceration or gangrene.
* Patients who required PTA of only one limb (left versus right).

Exclusion Criteria:

* Patients with body temperature above 37 ° C.
* Patients with indications for open surgery.
* Patients requiring major amputation (above the ankle).
* Patients with acute occlusive or embolic limb ischemia.
* Patients with deep venous thrombosis of the lower extremity.

Primary outcomes:
measure: To determine the validity and reliability of IRTI in assessing foot blood perfusion and surgical success rate after PTA treatment.
timeFrame: up to 15 months
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Fangge Deng
state: Guangdong
Study officials:
References:
Clinical trial NCT06738433: Efficacy and Tolerability of ABB I5 Prebiotic and ABB C22 Postbiotics for the Management of Constipation and Gastrointestinal Well-being: a Pilot Trial
Official title: Efficacy and Tolerability of ABB I5 Prebiotic and ABB C22 Postbiotics for the Management of Constipation and Gastrointestinal Well-being: a Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Constipation
Keywords: constipation
prebiotic
postbiotic
gastrointestinal
dietary supplement
Lead sponsor: AB Biotek
Sponsor class: INDUSTRY
Collaborators: name: Grupo Colisée
First posted: 2024-12-17
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study, we aim at assessing the benefits of dietary supplementation with ABB i5 and ABB C24, a combination of the the prebiotic ABB i5 and the postbiotic ABB C22, on the gut microbiota of people with constipation and on their gastrointestinal well-being.


Eligibility criteria: Inclusion Criteria:

* Subjects who require hospitalization
* Constipation defined as the Rome IV criteria for constipation
* Patients with the ability to take the study product orally

Exclusion Criteria:

* History of allergy, idiosyncrasy, hypersensitivity or adverse reactions to the active principle or to any of the excipients.
* History or evidence of any medical conditions or medication used that, in the opinion of the principal investigator, could affect the safety of the subjects or interfere with the study evaluations
* Patients last palliative care en stage of "end of life" or "terminal"
* Amytriptilin (anti-depressive) and masalazine (anti-inflammatory) treatment
* Laxatives
* Antibiotic treatment in the previous 2 weeks
* Patients with IBS or any other gastrointestinal conditions that maybe the cause of the constipation

Primary outcomes:
measure: Microbiota composition
timeFrame: from baseline to day 14 of supplementation
Secondary outcomes:
measure: Transit time
timeFrame: from baseline to day 14 of supplementation
measure: Tolerance and gastro-intestinal comfort
timeFrame: from baseline to day 14 of supplementation
measure: Brain Derived Neurotrophic Factor (BDNF)
timeFrame: from baseline to day 14 of supplementation
Other outcomes:
Locations:
city: Barcelona
country: South Sudan
facility: Isabel Roig
Study officials:
References:
Clinical trial NCT02087033: Use of Ritmonutra in Subjects Affected by Supraventricular Ectopic Beats Without Structural Heart Disease
Official title: A Randomized, Double-blinded, Cross-over Study on the Use of Ritmonutra, a Nutraceutical Product Composed of Omega 3 Fatty Acids, Astaxanthin, Vitamin E and Hawthorn in Subjects Affected by Supraventricular Ectopic Beats Without Structural Heart Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Arrhythmia
Keywords: supraventricular ectopic beats
Lead sponsor: IRCCS Policlinico S. Donato
Sponsor class: OTHER
First posted: 2014-03-14
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: it is a prospective, randomized, double-blinded, crossover study on the use of an association of omega 3 fatty acids, astaxanthin, vitamin E and hawthorn (ritmonutra) in subject affected by symptomatic supraventricular ectopic beats without structural heart disease.

The study will evaluate the reduction of the number of supraventricular ectopic beats and symptoms related.

Detailed description: 24 subjects without structural heart disease with a minimum of 300 supraventricular ectopic beats in 24 hours will be enrolled in the two participating centers and randomized to the treatment or to the placebo for 4 weeks. At the end of the first treatment period, a 24 hours Holter ECG will be performed. After 1 week of wash-out therapy, subjects will be crossed over to the other treatment for 4 weeks. Another 24 hours Holter ECG will be performed at the end of the study. During the baseline visit and during each follow up visit, symptom score and quality of life questionnaires will be completed by the subjects.

Eligibility criteria: Inclusion Criteria:

* age: 18 to 80 years
* symptomatic supraventricular ectopic beats (at least 300 in 24 hours recording)
* no structural heart disease evaluated with ecg, echocardiography, stress test and chest x-ray.
* no antiarrhythmic drug in use.

Exclusion Criteria:

* acute systemic illness
* preexcitation
* 3 or more consecutive ectopic beats
* vascular disease
* diabetes
* asthma
* soy allergy.

Primary outcomes:
measure: Efficacy in reduction of supraventricular ectopic beats
timeFrame: 4 weeks of treatment
Secondary outcomes:
measure: Efficacy in reduction of symptoms related to supraventricular ectopic beats
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Ponte San Pietro
country: Italy
facility: Policlinico San Pietro
state: Bergamo
city: San Donato Milanese
country: Italy
facility: Policlinico San Donato
state: Milan
Study officials:
affiliation: Policlinico San Donato
name: riccardo cappato, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01700933: Dose-response: Exercise Therapy on Hip Osteoarthritis
Official title: Dose-response: Exercise Therapy on Hip Osteoarthritis, a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Hip
Keywords: Exercise therapy
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
First posted: 2012-10-04
Enrollment: 35
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Osteoarthritis is a common disease that causes muscle weakness, stiffness and instability. The disease reduces the opportunities for an active lifestyle. Exercise Therapy provides a well-documented effect on pain and function in patients with osteoarthritis of the hip. It is sought an optimal dose of exercise, in which this study will help to investigate.

We hypothesize that an exercise program designed to have a high number of repetitions will benefit the outcome of the training in a more positive way than a low-repetition based program.


Eligibility criteria: Inclusion Criteria:

* At least three month since debut of the disease
* Age above 45 years
* Ability to complete the intervention

Exclusion Criteria:

* Pain above 4 on VAS during gait
* Pregnancy
* Autoimmune disease
* Cardiovascular disease
* Respiratory disease
* Metabolic disease
* Neurological signs
* Planned hip-replacement surgery within the next year
* Received exercise therapy within the last 3 months

Primary outcomes:
measure: WOMAC Index of Osteoarthritis (questionnaire)
timeFrame: 0 weeks, 8 weeks, 6 months postinterventional
Secondary outcomes:
measure: HAD questionnaire
timeFrame: 0 weeks, 8 weeks, 6 months postinterventional
measure: Tampa Scale for Kinesiophobia
timeFrame: 0 weeks, 8 weeks, 6 months postinterventional
measure: Squats
timeFrame: 0 weeks, 8 weeks, 6 months postinterventional
measure: Stairs
timeFrame: 0 weeks, 8 weeks, 6 months postinterventional
Other outcomes:
Locations:
city: Ørsta
country: Norway
facility: Fysioterapitjenesten i Ørsta
Study officials:
affiliation: Norwegian University of Science and Technology
name: Håvard Østerås
role: PRINCIPAL_INVESTIGATOR
References:
citation: Osteras H, Paulsberg F, Olsen SE, Osteras B, Torstensen TA. Effects of medical exercise therapy in patients with hip osteoarthritis: A randomized controlled trial with six months follow-up. A pilot study. J Bodyw Mov Ther. 2017 Apr;21(2):284-289. doi: 10.1016/j.jbmt.2016.06.016. Epub 2016 Jul 5.
Clinical trial NCT02071433: Analgesic Efficacy of Saphenous Nerve Blockade for Outpatient Knee Anterior Cruciate Ligament Surgery
Official title: Analgesic Efficacy of Saphenous Nerve Blockade for Outpatient Knee Anterior Cruciate Ligament Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postoperative Analgesia for Anterior Cruciate Ligament Surgery of the Knee
Keywords: Saphenous nerve block
Adductor canal block
Anterior cruciate ligament
Pain management
Day care
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2014-02-25
Enrollment: 58
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: The purpose of this study is to determine whether blockade of the saphenous nerve can provide the same degree of analgesia postoperatively for ACLS as a femoral nerve block without resulting motor blockade enhancing shortening of hospital stay en functional outcome.


Eligibility criteria: Inclusion Criteria:

* age 18-65 years
* ASA status I - III
* rupture of the anterior cruciate ligament.

Exclusion Criteria:

* contraindication for regional anesthesia
* allergy against local anesthetics
* BMI \> 35
* pre-existing diagnosed neuropathy of the operated leg
* ingestion of strong opioids
* pregnancy or breastfeeding status
* History of significant cardiovascular disease (MI, CVA, peripheral vascular disease)

Primary outcomes:
measure: Readiness to discharge from day-care center in hours according to Post-Anesthetic Discharge Scoring System (PADSS).[
timeFrame: 1 day
Secondary outcomes:
measure: Motor block
timeFrame: 2 days
measure: Pain (VAS)
timeFrame: 2 days
measure: Sensory blockade extent
timeFrame: 1 Day
measure: Time to rescue analgesic and post operative opioid consumption
timeFrame: 1 Day
measure: Overall Benefit of Analgesia Score (OBAS)
timeFrame: 6 weeks
measure: SF-12 score
timeFrame: 12 weeks
measure: KOOS-score
timeFrame: 12 weeks
measure: IKDC-score
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Academic Medical Centre Amsterdam
Study officials:
References: