louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03762811: Post-Market Clinical Investigation of NanoFUSE® Bioactive Matrix
Official title: Post-Market Clinical Investigation of NanoFUSE® Bioactive Matrix
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Bone; Degeneration
Keywords: Demineralized Bone Matrix
Bone Graft
Fusion
Lead sponsor: NanoFUSE Biologics, LLC
Sponsor class: INDUSTRY
First posted: 2018-12-04
Enrollment: 100
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 purpose of this study is to determine fusion rates and compare clinical outcomes of the NanoFUSE® Bioactive Matrix during post-market clinical use.

Detailed description: NanoFUSE® is indicated to be placed into bony voids or gaps of the skeletal system that are not intrinsic to the stability of the bony structure (i.e. the posterolateral spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to bone. NanoFUSE® must be used with autograft as a bone graft extender in the posterolateral spine and pelvis. This product provides a bone graft substitute that remodels into the recipient's skeletal system.

Eligibility criteria: Inclusion Criteria:

* Skeletally mature
* Medically suitable for surgical management and the use of NanoFUSE® Bioactive Matrix consistent with product labeling
* Psychosocially, mentally, and physically able to fully comply with the protocol, including the post-operative regimen, requires follow-up visits, filling out required forms, and the ability to understand and give written informed consent
* Retrospective data collection must be allowed by the IRB and all information deidentified

Exclusion Criteria:

* Previous fusion surgery of the proposed site
* Use of chronic medications known to affect the skeleton (e.g. glucocorticoid usage \> 10mg/day)
* Pregnant or female intending to become pregnant during this study period
* Obesity (BMI \>40kg/m2)
* Systemic infection or infection at the surgical site
* Current or past substance abuse
* Poor general healthy or any concurrent disease process that would place the patient in excessive risk to surgery (e.g. significant circulatory or pulmonary problems, cardiac disease
* Medical condition that would interfere with post-operative assessments and care

Primary outcomes:
measure: Radiographic Success that indicates patient achieving fused or probably fused status.
timeFrame: 12 months
Secondary outcomes:
measure: Overall patient success
timeFrame: 12 months postoperatively
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05987111: Pilates in Ankylosing Spondylitis
Official title: Comparison of Efficacy of Two Different Pilates Exercise Methods in Individuals With Ankylosing Spondylitis: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ankylosing Spondylitis
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 20
Sex: ALL
Minimum age (years): 20
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 was planned to examine and compare the effectiveness of two different pilates exercise methods (mat pilates vs reformer pilates) in individuals with Ankylosing Spondylitis(AS).


Eligibility criteria: Inclusion Criteria:

* Being in the age range of 20-65, using stable medication for at least 3 months, being sedentary (Not regularly participating in exercise activities for the past 3 months).

Exclusion Criteria:

* the presence of cardiovascular, pulmonary, orthopedic and neurological problems, another rheumatic disease, being pregnant, inability to participate in at least 75% of the exercises.

Primary outcomes:
measure: Bath Ankylosing Spondylitis Metrology Index
timeFrame: 10 minutes
measure: Bath Ankylosing Spondylitis Disease Activity Index
timeFrame: 5minutes
measure: Bath Ankylosing Spondylitis Functional Index (BASFI)
timeFrame: 5 minutes
measure: Ankylosing Spondylitis Quality of Life Questionnaire
timeFrame: 5 minutes
measure: Maastrich Ankylosing Spondylitis Enthesitis Score
timeFrame: 5minutes
measure: Multidimensional Assessment of Fatigue Scale
timeFrame: 5 minutes
measure: Biopsychosocial Questionnaire (BETY-BQ)
timeFrame: 10minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Usak
country: Turkey
facility: Usak University
state: Merkez
Study officials:
References:
Clinical trial NCT05747911: Dietary Advanced Glycation End Products and Migraine
Official title: Are Dietary Intake of Advanced Glycation End Products and Migraine Associated? A Case-control Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nutrition Disorders
Migraine Disorders
Lead sponsor: Karabuk University
Sponsor class: OTHER
First posted: 2023-02-28
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult individuals aged 19-64 who applied to Karabuk University Training and Research Hospital Neurology Clinic Headache Outpatient Clinic

Brief summary: Is dietary intake of advanced glycation different between individuals with and without migraine? Is there a difference between the groups in terms of energy and nutrients? The answers to these questions are sought.


Eligibility criteria: Inclusion Criteria:

* To be diagnosed with episodic migraine by an experienced neurologist,
* For the control group, patients who were not diagnosed with migraine but applied to the headache outpatient clinic
* Volunteer

Exclusion Criteria:

* Being younger than 19 years and older than 64 years of age, having a history of cardiovascular disease, hypertension, diabetes, cancer, liver and kidney disease or other neurological disorder (epilepsy, multiple sclerosis, stroke, traumatic brain injury, etc.), secondary headache, antilipidemic and glucose taking intolerance medications or vitamin-mineral supplements, following a special diet, and consuming less than 800 kcal or more than 4000 kcal per day

Primary outcomes:
measure: Difference in dietary advanced glycation end products intake between groups
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Karabük
country: Turkey
facility: Karabuk University
Study officials:
References:
Clinical trial NCT04310111: EUS-RFA for Unresectable Pancreatic Cancer
Official title: Efficacy and Safety of Endoscopic Ultrasonography-guided Radiofrequency Ablation in Treatment of Locally Advanced, Unresectable Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatic Ductal Adenocarcinoma
Keywords: Pancreatic ductal adenocarcinoma
Unresectable pancreatic cancer
Radiofrequency ablation
Endoscopic ultrasound
Lead sponsor: First People's Hospital of Hangzhou
Sponsor class: OTHER
First posted: 2020-03-17
Enrollment: 8
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The clinical application of intraoperative or percutaneous radiofrequency ablation (RFA) for pancreatic ductal adenocarcinoma (PDAC) is limited due to higher mortality and incidence of adverse events. The aim of this study was to evaluate the efficacy and safety of endoscopic ultrasonography-guided RFA (EUS-RFA) for locally advanced, unresectable PDAC. Patients with unresectable PDAC who underwent EUS-RFA were included from September 2013 to June 2016. Pre- and post-procedural clinical data was retrospective collected.

Detailed description: evaluate the efficacy and safety of endoscopic ultrasonography-guided RFA (EUS-RFA) for locally advanced, unresectable PDAC.

Eligibility criteria: Inclusion Criteria:

* age 20 to 80 years old. ② unresectable PDAC based on review of abdominal cross-sectional imaging (CT or MRI) and cytology/ histology results. ③Intolerance to chemotherapy due to side effects or patient's comorbidities.

Exclusion Criteria:

* Pregnancy or breast-feeding；②ECOG performance status 3 or 4；③Patients with distant metastases or malignant ascites, life expectancy less than 3 months.

Primary outcomes:
measure: Tumor size
timeFrame: 2 years
Secondary outcomes:
measure: Serum levels of CA19-9
timeFrame: 2 years
measure: survival rate
timeFrame: 2 years
measure: Adverse events
timeFrame: 2 years
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Hangzhou First People's Hospital
state: Zhejiang
Study officials:
affiliation: First People's Hospital of Hangzhou
name: Xiaofeng Zhang, M.S
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01643811: Effect of Gastrectomy and Anastomosis on Diabetes and Hypertension in Early Gastric Cancer Patients
Official title: Effect of Gastrectomy and Anastomosis on Chronic Metabolic Disease Such as Diabetes and Hypertension in Early Gastric Cancer Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Early Gastric Cancer
Keywords: early gastric cancer, diabetes, hypertension
Lead sponsor: National Cancer Center, Korea
Sponsor class: OTHER_GOV
First posted: 2012-07-18
Enrollment: 159
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients diagnosed as early gastric cancer

Brief summary: The purpose of this study is to determine whether the extent of gastrectomy and anastomosis type affect chronic metabolic disease such as diabetes and hypertension in early gastric cancer patients.


Eligibility criteria: Inclusion Criteria:

* Histologically proven primary gastric adenocarcinoma
* clinical stage Ia or Ib examined with endoscopy, endoscopic ultrasound, and computed tomography
* aged 20-80 year old,
* performance status (PS) of 0 or 1 on Eastern Cooperative Oncology Group (ECOG) scale
* diagnosed as diabetes or hypertension
* patients planning to undergo gastrectomy or endoscopic submucosal dissection
* written informed consent

Exclusion Criteria:

* having high risk for operation such as severe heart disease, severe respiratory disease
* pregnant
* previous abdominal surgery or radiation therapy
* proven more advanced disease than pathological stage II requiring adjuvant chemotherapy

Primary outcomes:
measure: Proportion of patients who quit previous medication for diabetes because of improved disease
timeFrame: 5 year after operation
measure: Proportion of patients who quit previous medication for hypertension because of improved disease
timeFrame: 5 years after operation
Secondary outcomes:
measure: difference of proportion of patients who quit previous medication for diabetes between patients who underwent subtotal gastrectomy and those who underwent total gastrectomy
timeFrame: 5 years after operation
measure: difference of proportion of patients who quit previous medication for diabetes according to anastomosis
timeFrame: 5 year after operation
measure: difference of proportion of patients who quit previous medication for hypertension between patients who underwent subtotal gastrectomy and those who underwent total gastrectomy
timeFrame: 5 years after operation
measure: difference of proportion of patients who quit previous medication for hypertension according to anastomosis
timeFrame: 5 years after operation
measure: difference of serum levels of c-peptide, Ghrelin, GIP, GLP-1, glucagon, insulin between before and after operation
timeFrame: 1 years after operation
Other outcomes:
Locations:
city: Goyang
country: Korea, Republic of
facility: National Cancer Center
state: Kyeonggi-do
Study officials:
References:
Clinical trial NCT01975311: Effect of Lower Back Treatment in People With Patellofemoral Pain Syndrome.
Official title: Effect of Lumbopelvic Manipulation on Hip and Knee Neuromuscular Activity, Pain Intensity, and Functional Activity in People With Patellofemoral Pain Syndrome.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patellofemoral Pain Syndrome
Lead sponsor: Texas Woman's University
Sponsor class: OTHER
First posted: 2013-11-03
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if a lower back treatment would change the knee pain intensity and the level of functional activities as well as the muscle activities in people with anterior knee pain. The investigators hypothesized that the lower back treatment may change the hip and knee muscle activities as well as reduce the knee pain intensity and improve the functional activities in people with anterior knee pain.


Eligibility criteria: Inclusion Criteria:

* Insidious onset of symptoms of non-traumatic origin.
* Pain with patellar facet palpation or compression.
* anterior or retropatellar knee pain during at least two of the following activities: (a) ascending stairs, (b) descending stairs, (c) kneeling, (d) squatting, (e) hopping, (f) running, (j) jumping, (h) prolonged sitting for more than 20 minutes.

Exclusion Criteria:

* History of spine, hip or knee surgery.
* History of hip pathology or other knee condition.
* Current significant injury of any lower extremity joints.
* Pregnancy.
* Sign of nerve root compression.
* Osteoporosis or history of compression fracture.

Primary outcomes:
measure: Electromyography (EMG) of the hip and knee muscle
timeFrame: The EMG data will be collected within one week for all participants in both groups.
Secondary outcomes:
measure: Pain Visual Analog Scale (VAS)
timeFrame: The pain VAS data will be collected within one week for all participants in both groups
measure: Lower Extremity Functional Scale (LEFS)
timeFrame: The LEFS data will be collected within one week for all participants in both groups.
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Texas Woman's University, School of Physical Therapy - Dallas Campus
state: Texas
Study officials:
References:
Clinical trial NCT04945811: Role of Interleukin-6 and Procalcitonin as Novel Inflammatory Biomarkers in Evaluating COVID 19 Disease Severity - an Experience at CMH Quetta
Official title: Role of Interleukin-6 and Procalcitonin in Evaluating COVID 19 Disease Severity - an Experience at CMH Quetta
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid19 Positive Patients
Lead sponsor: Combined Military Hospital, Pakistan
Sponsor class: OTHER
First posted: 2021-06-30
Enrollment: 100
Sex: ALL
Minimum age (years): 38
Maximum age (years): 71
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Serum Interleukin-6 and Procalcitonin of 100 consenting COVID 19 positive patients from April 2020 - May 2021 were assessed at Pathology department CMH Quetta and the results were correlated with severity of lung involvement on HRCT Chest

Detailed description: Objective: To explore the relation between Interleukin-6 and Procalcitonin with COVID severity on HRCT Chest Study Design: Randomized Control Trial (Clinical Trials. gov Identifier: NCT04798391) Place and duration of study: Pathology, Radiology \& ENT Department CMH Quetta from April 2020 - May 2021 Methodology: Serum Interleukin-6 and Procalcitonin of 100 consenting COVID 19 positive patients from April 2020 - May 2021 were assessed at Pathology department CMH Quetta and the results were correlated with severity of lung involvement on HRCT Chest Results: Serum Interlukin-6 levels were raised in 97 (97%) patients with mean levels of 20.43 + 19.66 (pg/ml). Serum procalcitonin levels were raised in 95 (95%) patients with mean levels of 0.4331 + 0.24 (ng/ml). A P value of \<0.001 was calculated on Independent Sample T-test for both serum interlukin-6 and serum procalcitonin as correlated with severity of lung involvement on HRCT Chest.

Conclusion: Interlukin-6 and procalcitonin are excellent biomarkers for diagnosis and predicting severity of COVID19 pneumonia.

Keywords: Covid19 pneumonia, Interlukin-6, procalcitonin.

Eligibility criteria: Inclusion Criteria:

* positive PCR of COVID 19

Exclusion Criteria:

* NEGATIVE PCR of COVID 19

Primary outcomes:
measure: Levels of inflammatory biomarkers is raised in accordance with severity of COVID 19
timeFrame: 2 days
Secondary outcomes:
Other outcomes:
Locations:
city: Quetta
country: Pakistan
facility: Cmh Quetta
state: Balochistan
Study officials:
References:
Clinical trial NCT04652011: Long-term Management of Patients Surgically Treated for Chronic Pelvic Pain by Minimally Invasive Surgery
Official title: Long-term Management of Patients With Benign Gynecological Pathology and Chronic Pelvic Pain and Follow-up After Minimally Invasive Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pelvic Pain
Keywords: Pelvic Pain
Endometriosis
Minimally invasive Surgery
Lead sponsor: Azienda Ospedaliero-Universitaria di Modena
Sponsor class: OTHER
First posted: 2020-12-03
Enrollment: 250
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with chronic pelvic pain and a benign gynecologic disease associated, referring to Gynecologic Unit of University Hospital of Modena, who underwent minimally invasive surgery from 2010 to 2019

Brief summary: It is a retrospective observational study based on the analysis of the medical records of patients treated for chronic pelvic pain and benign gynecological pathologies at the Gynecology Unit of the University Hospital of Modena from 2010 to 2019. The aim of the study is to analyze the effects of medical and surgical treatments on chronic pelvic pain and associated pathologies.


Eligibility criteria: Inclusion Criteria:

* Underwent Minimally invasive gynecologic surgery from 2010 to 2019
* Chronic pelvic pain
* Benign gynecologic disease (Endometriosis, myoma, adenomyosis, pelvic organ prolapse

Exclusion Criteria:

* malignant gynecologic disease
* chronic pelvic pain not linked to gynecologic disease

Primary outcomes:
measure: Change From Baseline in Pain Scores on the Numeric Rating Scale at 6 months after surgery
timeFrame: Baseline and 6 months after surgery
measure: Change From Baseline in Pain Scores on the Numeric Rating Scale at 6 months after Osteopathic manipulative treatment
timeFrame: Baseline and 6 months after Osteopathic manipulative treatment
Secondary outcomes:
measure: Change From Baseline in constipation on the constipation score system (CSS) by Agachan-Wexner at 6 months after surgery
timeFrame: Baseline and 6 months after surgery
measure: Analysis of postoperative complications using Clavien-Dindo classification
timeFrame: 1 month after surgery
measure: Incidence of endometriosis among patients with chronic pelvic pain
timeFrame: Baseline
Other outcomes:
Locations:
city: Modena
country: Italy
facility: Carlo Alboni
Study officials:
References:
Clinical trial NCT03155711: HFNC for Induction During Bariatric Surgery Patients.
Official title: Study Protocol for the Use of High Flow Nasal Oxygen During the Anesthesia Induction and Weaning in Patients Scheduled for Bariatric Surgery. A Randomized Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Collapse
Lead sponsor: Fundación para la Investigación del Hospital Clínico de Valencia
Sponsor class: OTHER
First posted: 2017-05-16
Enrollment: 64
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: This study aims to compared the effects of high flow nasal during the induction and during the weaning of anesthesia on intraoperative and postoperative oxygenation and postoperative atelectasis in obese patients undergoing bariatric surgery versus the standard of care, which consists in supplemental oxygen with face mask (Venturi mask).


Eligibility criteria: Inclusion Criteria:

* Body mass index \> 35 Kg/m2
* Bariatric surgery
* Informed consent signed

Exclusion Criteria:

* age \<18yr or \>80yr
* pregnancy or breast-feeding status
* patients with previous known respiratory disease
* hemodynamic instability at entry (need of vasopressors or ionotropes at entry or a ventricular assist device

Primary outcomes:
measure: Oxygenation
timeFrame: intraoperative
Secondary outcomes:
measure: Oxygenation
timeFrame: First 24 postoperative hours
measure: Atelectasis
timeFrame: First 24 postoperative hours
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Hospital clínico universitario
Study officials:
References:
citation: Eichenberger A, Proietti S, Wicky S, Frascarolo P, Suter M, Spahn DR, Magnusson L. Morbid obesity and postoperative pulmonary atelectasis: an underestimated problem. Anesth Analg. 2002 Dec;95(6):1788-92, table of contents. doi: 10.1097/00000539-200212000-00060.
citation: Coussa M, Proietti S, Schnyder P, Frascarolo P, Suter M, Spahn DR, Magnusson L. Prevention of atelectasis formation during the induction of general anesthesia in morbidly obese patients. Anesth Analg. 2004 May;98(5):1491-5, table of contents. doi: 10.1213/01.ane.0000111743.61132.99.
citation: Ireland CJ, Chapman TM, Mathew SF, Herbison GP, Zacharias M. Continuous positive airway pressure (CPAP) during the postoperative period for prevention of postoperative morbidity and mortality following major abdominal surgery. Cochrane Database Syst Rev. 2014 Aug 1;2014(8):CD008930. doi: 10.1002/14651858.CD008930.pub2.