louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02335788: EMBA Peripheral Embolization Device ("EPED") Study
Official title: EMBA Peripheral Embolization Device ("EPED") Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Embolization
Keywords: Therapeutic
Embolization
Lead sponsor: EMBA Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2015-01-12
Enrollment: 15
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 an open label, acute, non-randomized, prospective, "first in man" (FIM) single-center study of the EMBA Medical Peripheral Embolization Device (PED).

Detailed description: This study is a FIM, open label, prospective, single center, non-randomized, evaluation of the EMBA Medical Peripheral Embolization Device (PED) used for arterial or venous embolization in the peripheral vasculature.

Eligibility criteria: Inclusion Criteria:

1. The patient is \>18 years of age.
2. Patient is considered a candidate for arterial or venous embolization in the peripheral vasculature.
3. Patient has a target vessel diameter of 3-8mm and a target PED landing zone of greater than 25mm wherein the vessel diameter is between 3 and 8 mm.
4. The patient or legal guardian has been informed of the nature of the study and agrees to its provisions and has provided informed written consent.
5. The patient has suitable vessel anatomy that would allow proper placement of the PED.

Exclusion Criteria:

1. The patient has one of the following conditions:

   1.1 Arterio-venous fistula 1.2 Hypercoagulability 1.3 Systemic coagulopathy 1.4 Connective tissue disorder such as Ehlers-Danlos Syndrome 1.5 Congenital arteritis such as Takayasu's Disease 1.6 Other circulatory disorders at the discretion of the implanting physician
2. The patient has an uncontrolled infectious disease.
3. The patient has a life expectancy of less than 6 months.
4. The patient is pregnant.
5. The patient has a condition that inhibits radiographic visualization of the PED.
6. The patient has a known allergy or intolerance to Nitinol.
7. The patient has a known hypersensitivity to contrast that cannot be pre-treated.
8. The patient's access vessels preclude safe insertion of the delivery system.
9. The patient is currently participating in another device or drug study.

Primary outcomes:
measure: Target vessel occlusion (assessed by CTA)
timeFrame: 30 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Grafton
country: New Zealand
facility: Auckland City Hospital
state: Auckland
Study officials:
affiliation: Auckland City Hospital
name: Andrew Holden, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05683288: Short and Long Time Effects of IASTM and Myofascial Release Techniques in Chronic Neck Pain
Official title: Comparison of the Efficiency of Instrument Assisted Soft Tissue Mobilization and Myofascial Release Techniques in Individuals With Chronic Neck Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Neck Pain
Keywords: Chronic Neck Pain
Disability
Pain
Lead sponsor: KTO Karatay University
Sponsor class: OTHER
First posted: 2023-01-13
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to determine whether EYYDM and myofascial applications have short and long-term effects on pain and disability in individuals diagnosed with chronic neck pain.

Detailed description: Participants will be randomly assigned to IASTM, myofascial release and control groups. In addition to conventional treatment, IASTM and myofascial release groups will be treated twice a week for 4 weeks. Conventional treatment will be applied to the control group for 4 weeks.

Eligibility criteria: Inclusion Criteria:

* having a diagnosis of chronic neck pain,
* To have given at least 3 values to the pain with the Numerical Pain Scale
* having bilateral muscle spasms in the cervical region

Exclusion Criteria:

* those who are taking any analgesic medication,
* those with acute injury or infection,
* those with open wounds,
* osteoporosis,
* fracture,
* hematoma,
* those with acute cardiac, liver and kidney problems,
* those with connective tissue disease,
* rheumatoid arthritis, osteoarthritis,
* cancer,
* those with circulation problems,
* those with peripheral vascular disease,
* epilepsy,
* history of surgery in the cervical region

Primary outcomes:
measure: Change from Baseline Cervical Pain assessed by Numeric Pain Scale.
timeFrame: Baseline, 4 weeks
Secondary outcomes:
measure: Change from Baseline Cervical Disability assessed by Neck Disability Index
timeFrame: Baseline, 4 weeks
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: KTO Karatay University
state: Karatay
Study officials:
References:
Clinical trial NCT03269188: Incidence and Associated Factors of Persistent Postoperative Incision Scar Pain Following C/s in Mulago Hospital
Official title: Incidence and Associated Factors of Persistent Postoperative Incision Scar Pain Following C/s in Mulago Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Pain
Lead sponsor: Makerere University
Sponsor class: OTHER
First posted: 2017-08-31
Enrollment: 277
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: women scheduled to undergo both elective and emergency caesarean section in the obstetric theatres of mulago national referral hospital during the study period and meet the eligibility criteria.

Brief summary: prospective cohort study of women who underwent caesarean section in mulago hospital. followed up for 2 months and assessed for development of persistent post operative pain at the incision site and its effect on quality of life. incidence of persistent postoperative pain and associated factors determined.

Detailed description: prospective cohort study of 277 women who underwent caesarean section in mulago hospital. demographic, medical history, intraoperative, postoperative details, and perioperative levels of pain collected. followed up by telephone interviews for 2 months and assessed for development of persistent post operative pain at the incision site and its effect on quality of life. incidence of persistent postoperative pain and associated factors determined.

Eligibility criteria: Inclusion Criteria:

- ASA I, II, and III.

* patient who has given informed consent.

Exclusion Criteria:

* patients who have no telephone contact

Primary outcomes:
measure: persistent postoperative pain at caesarean section incision scar site.
timeFrame: 2 months.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05979688: Yogic Breathing Exercise for People With Amyotrophic Lateral Sclerosis
Official title: Yogic Breathing Exercise for People With Amyotrophic Lateral Sclerosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Amyotrophic Lateral Sclerosis
Myasthenia Gravis
Keywords: Amyotrophic Lateral Sclerosis
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2023-08-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

Brief summary: The aim of this study is to understand how well a 6-week virtual yogic breathing exercise program (YBEP) will improve breathing, speech, and emotional well-being in people with amyotrophic lateral sclerosis (ALS).

Detailed description: The study will employ a RCT to test the two hypotheses. The study will incorporate a 2 x 2 two-way factorial design with repeated measures at three time points. The two between-subject factor conditions will be participation in a yogic breathing exercise program (YBEP) versus a waitlist control condition that will be evaluated at baseline, and immediately post-program. Thirty adults with ALS will be recruited for this study.

Hypothesis #1: Adults with ALS who participate in a YBEP will demonstrate improvement in breathing, and emotional well-being compared to waitlist controls at the conclusion of a 6-week YBEP.

Eligibility criteria: Inclusion Criteria:

1. confirmed ALS or myasthenia gravis diagnosis
2. age \>18 yrs old;
3. ability to follow multistep commands,
4. on a stable dose of medications for \>60 days,
5. FVC ≥30% predicted,
6. access to internet and a computer or smartphone that can perform videoconferencing.

Exclusion Criteria:

1. life expectancy is less than 6 months,
2. severe hearing or visual impairments that prevent online learning (breathing exercise), or
3. current participation in another clinical trial during the study period that can affect the outcomes of the study.

Primary outcomes:
measure: ALS Specific Quality of Life-Revised
timeFrame: baseline
measure: ALS Specific Quality of Life-Revised
timeFrame: at 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Hon Yuen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pagnini F, Marconi A, Tagliaferri A, Manzoni GM, Gatto R, Fabiani V, Gragnano G, Rossi G, Volpato E, Banfi P, Palmieri A, Graziano F, Castelnuovo G, Corbo M, Molinari E, Riva N, Sansone V, Lunetta C. Meditation training for people with amyotrophic lateral sclerosis: a randomized clinical trial. Eur J Neurol. 2017 Apr;24(4):578-586. doi: 10.1111/ene.13246. Epub 2017 Feb 23.
Clinical trial NCT01117688: Ureteroscopy With and Without Safety Guidewire
Official title: Ureteroscopy With and Without Safety Guidewire:. A Prospective, Randomized Study of the Results of Endoscopic Treatment of Urolithiasis.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Urolithiasis
Keywords: Ureteroscopy
Lead sponsor: Helse-Bergen HF
Sponsor class: OTHER
First posted: 2010-05-05
Enrollment: 0
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: The purpose of this study is to investigate the impact of a safety guidewire (SGW) on the results of ureteroscopy for urolithiasis.

Study hypothesis: Routine use of SGW has no impact on the results of ureteroscopic treatment of urolithiasis.

Detailed description: The use of SGW is generally recommended at any ureteroscopic procedure in order to facilitate the introduction of the endoscope and to secure placement of internal tubes for drainage of urine after the procedure.

However, SGW may be an obstacle to efficient disintegration and retraction of calculi in the narrow ureter.

The intention of this study is to compare the results of endoscopic stone treatment with and without the use of SGW.

Eligibility criteria: Inclusion Criteria:

* Patients with urolithiasis planned for ureterorenoscopic treatment

Primary outcomes:
measure: Stone free-rate
timeFrame: 3 months after treatment
Secondary outcomes:
measure: Hospital stay
timeFrame: Up to 1 week after the operation
measure: Complication rate
timeFrame: Until 3 months after the procedure
measure: Operating time
timeFrame: Up to 1 day after the surgery
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Helse Bergen HF, Haukeland University Hospital
Study officials:
affiliation: Helse Bergen HF, Haukeland University Hospital
name: Øyvind Ulvik, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05462288: Entia Liberty: Home Study
Official title: Entia Liberty: Home Study - Evaluation of Patient Preference for a Novel Full Blood Count Home Testing Device Versus Routine Venous Monitoring
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Lead sponsor: Entia Ltd
Sponsor class: INDUSTRY
First posted: 2022-07-18
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: New or existing patients on specific drug treatments recruited by their consultants

Brief summary: Participants will be testing with the home monitoring device over the course of their treatment. They are to self-test on days where they are due to be going into hospital for their routine pre-treatment blood tests. Participants will be asked to fill in interim questionnaires and a final questionnaire to answer the study objectives.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18
* Adequate English language skills (not requiring a translator) to participate in participant training and use the Liberty device
* Patients willing and able to perform capillary blood self-testing at the same frequency as routine full blood count monitoring
* Patients capable of providing informed consent before attending training
* Patients able to attend a 1-hour virtual training session within 2 weeks of joining the study
* Patients with a home Wi-Fi network or with adequate coverage at home via a 4G network
* Patients with access to a laptop or smartphone to facilitate training
* Patients with a diagnosis of ovarian or breast cancer
* Patients whose HCPs can confirm are undergoing systemic anti-cancer treatments within two weeks of enrolment, with treatment expected to continue for at least two cycles

Exclusion Criteria:

* Patients with haematological malignancies
* Patients with eyesight or hearing limitations or other disabilities that preclude the use of the Liberty device or participation in training unless they have a nominated caregiver who is capable of assisting with each test

Primary outcomes:
measure: To assess patient preference for the Liberty self-testing pathway as compared to standard of care.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust
Study officials:
References:
Clinical trial NCT02169388: Intestinal Microflora in Colorectal Cancer (CRC) After Chemotherapy
Official title: Effects of Gut Microflora on the Immune and Nutritional Status of CRC Patients After Chemotherapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Gastrointestinal Neoplasms
Colorectal Cancer
Effects of Chemotherapy
Tumor Immunity
Malnutrition
Keywords: Gut microflora
colorectal cancer
Chemotherapy
Immunity
Nutrition
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2014-06-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Probiotics modulate the gut microflora and immune status in CRC,which can reduce the side effects of chemotherapy such as diarrhea,infection,neutropenia etc.

Detailed description: Chemotherapy destroys the intestinal mucosal barrier, affects intestinal flora, causing bacterial translocation, infection and other complications; Probiotics may restore the intestinal immunity, mucosal barrier, and nutrient absorption.The adverse effects of chemotherapy and the malnutrition status may be relieved via probiotic administration.

Eligibility criteria: Inclusion Criteria:

* Patients scheduled for chemotherapy after radical resection of colorectal cancer

Exclusion Criteria:

* Palliative resection of colorectal cancer
* Antibiotic,probiotic or prebiotic usage within 1months
* Other malignancy
* History of other abdominal surgery
* Coagulopathy or bleeding disorders
* Pregnant or breast-feeding(for females)
* Impaired liver or renal function

Primary outcomes:
measure: Composition of Microorganisms in stool after probiotic intervention
timeFrame: 5 months
measure: Short-chain fatty acids in feces of patients after chemotherapy
timeFrame: 5 months
measure: Frequency and severity of Adverse effects during Chemotherapy
timeFrame: 5 months
Secondary outcomes:
measure: The observed changes in immune status after chemotherapy
timeFrame: 5 month
measure: The observed changes in nutritional status after chemotherapy
timeFrame: 5 months
Other outcomes:
Locations:
city: Jinan
country: China
facility: Department of Gastroenterology,Qilu Hospital,Shandong University
state: Shandong
Study officials:
affiliation: Qilu Hospital, Shandong University
name: Yanqing Li, MD.PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02082288: Edessy ICSI Outcome Embryo Score (EIOS) Efficacy
Official title: Edessy ICSI Outcome Embryo Score (EIOS) Efficacy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Infertility
Keywords: ICSI outcome
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2014-03-10
Enrollment: 243
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Purpose of this study is to detect outcome of intracytoplasmic sperm injection (ICSI) according to EIOS

Detailed description: A total of 243 infertile couples underwent long GnRH agonist protocol in the ART unit, International Islamic Center for Population Studies and Research (IICPSR), Al-Azhar University.

Embryos which reached the two cell stage at 25-27 hr were classified as EC, and the remaining as Non Early Cleavage embryos (NEC). Embryos were assessed again at 64-68 hours post-ICSI for day three embryo morphology score (Loi et al.,2008). The best two or three embryos, according to day 3 embryo morphology were transferred. Each patient was given a score according to EIOS (female age, number of retrieved oocytes, number of EC embryos, number of good quality embryos and number of embryos transferred).

Eligibility criteria: Inclusion Criteria:

* Age ≤ 40 years old. BMI \>25 - 30 kg/m2. Have two ovaries. Regular cycles. 1st ICSI cycle. Long midluteal GnRH protocol

Exclusion Criteria:

uterine factor as a cause of female factor infertility. pelvic masses or diseases (e.g: endometriosis, fibroids, hydro- salpnix, ...). history of medical disorders (e.g: hypertension, D.M, thyroid dysfunction, liver diseases, renal diseases,...).

azoospermia as a cause of male factor infertility.

Primary outcomes:
measure: Clinical Pregnancy
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: International Islamic Center for Population Studies and Research (IICPSR), Al-Azhar university
Study officials:
affiliation: Al-Azhar University
name: Mahmoud Edessy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Al-Azhar University
name: Abd-Elnasr M Ali, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Al-Azhar University
name: Ahmed Fata, MD
role: STUDY_DIRECTOR
affiliation: Al-Azhar University
name: Wael M Hamed, MSc
role: STUDY_CHAIR
References:
Clinical trial NCT01853488: Bone Strength After Spinal Cord Injury
Official title: Impact of Spinal Cord Injury on Bone Strength in Paralysed Extremities.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Cord Injury
Keywords: Osteoporosis
BMD
SCI
DXA
pQCT
Lead sponsor: Swiss Paraplegic Research, Nottwil
Sponsor class: NETWORK
First posted: 2013-05-15
Enrollment: 273
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients of the Swiss Paraplegic Centre Nottwil (in-patient or out-patient).

Brief summary: Background:

After a traumatic spinal cord injury, a severe bone loss in the paralyzed extremities is observed. This leads to a osteoporosis which is connected to a high fracture risk.

Aims:

To compare the two measurement methods DEXA and pQCT concerning optimal diagnostics and assessment of fracture risk in subjects with spinal cord injury.

Subjects:

250 women and 250 men (age≥18, any AIS-classification) with an acute or chronic spinal cord injury will be recruited for this study. For a reference group, 500 able-bodied persons will be measured analogously.

Methods:

Using DEXA-Osteodensitometry, bone parameters of the lumbar vertebral column, proximal femur, distal radius, distal tibia and knee area will be assessed. Additionally, geometric bone parameters of the tibia will be measured by using pQCT. All measurements will be done unilaterally. For the assessment of potential risk factors for reduced bone stiffness after spinal cord injury a questionnaire will be used.


Eligibility criteria: Inclusion Criteria:

* Spinal Cord Injury
* mobilized patients
* written informed consent

Exclusion Criteria:

* current fracture
* limited mobility
* contractures of the lower limbs
* decubitus ulcer
* pregnancy

Primary outcomes:
measure: Bone parameters
timeFrame: just one timepoint
Secondary outcomes:
measure: Fractures
timeFrame: just one timepoint (questionnaire)
Other outcomes:
Locations:
city: Nottwil
country: Switzerland
facility: Swiss Paraplegic-Centre
state: Lucerne
Study officials:
affiliation: Swiss Paraplegic Research, Nottwil
name: Angela Frotzler, PhD
role: PRINCIPAL_INVESTIGATOR
References: