louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04038450: Accuracy of Visual Range of Motion Estimates
Official title: Accuracy of Visual Range of Motion Estimates Among Physical Therapists and Physical Therapy Students
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Accuracy of Estimation of Joint Range of Motion
Lead sponsor: Methodist University, North Carolina
Sponsor class: OTHER
First posted: 2019-07-30
Enrollment: 522
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adults who are currently enrolled in a DPT program or graduates and licensed physical therapy practioners.

Brief summary: Examine the accuracy of visual estimates of various joint angles by physical therapists at various levels of education and clinical practice, taking into account years of experience, areas of practices and specialty certifications.

Detailed description: Physical therapists oftentimes will estimate rather than measure joint range of motion. The accuracy of visual estimates of various joint measurements has not been previously assessed. No comparison has been done for years of experience and accuracy of estimations. This study will create a survey with pictures of joints at previously measured angles and therapists and students will be asked to estimate the range of motion. Various statistical analyses will be performed to determine accuracy and comparisons.

Eligibility criteria: Inclusion Criteria:

* licensed physical therapists
* students currently enrolled in an accredited doctorate of physical therapy program

Exclusion Criteria:

* students have not been trained in range of motion measurements
* are not licensed physical therapists

Primary outcomes:
measure: Comparison of estimated ROM to actual ROM
timeFrame: 6 months after completion of survey
Secondary outcomes:
Other outcomes:
Locations:
city: Fayetteville
country: United States
facility: Methodist University, North Carolina
state: North Carolina
Study officials:
affiliation: Methodist University
name: Penny Schulken, DPT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04483050: The Clinical Effect of Hip Protection Orthosis for the Hip Protection of Hip Dislocation in Patients With Severe Neuromuscular Disease, Pilot Study
Official title: The Clinical Effect of Hip Protection Orthosis for the Hip Protection of Hip Dislocation in Patients With Severe Neuromuscular Disease, Open Label, Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Korea Health Industry Development Institute
First posted: 2020-07-23
Enrollment: 4
Sex: ALL
Minimum age (years): 1
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The Clinical Effect of Hip Protection Orthosis for the Hip Protection of Hip Dislocation in Patients With Severe Neuromuscular Disease


Eligibility criteria: Inclusion Criteria:

* age from 1 to 15
* Patients with severe neuromuscular disease
* Patients who agreed to participate in the study
* Hip dislocation more than 10% (migration index)

Exclusion Criteria:

* If do not agree with the study
* Those who are determined to be difficult to participate under the judgment of the research director
* History of hip joint surgery

Primary outcomes:
measure: Migration index
timeFrame: 6 months
Secondary outcomes:
measure: Cobb's angle (')
timeFrame: 6 months
measure: Range of motion of hip joint (')
timeFrame: 6 months
measure: Visual analog scale
timeFrame: 6 months
measure: Likert scale (score)
timeFrame: immediately after wearing orthosis
measure: Child Health Index of Life with Disabilities (CPCHILD)
timeFrame: 6 months
Other outcomes:
Locations:
city: Gyeonggi-do
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Seongnam-si, Gyeonggi-do
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Juseok Ryu, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00267150: Gastrointestinal and Health-related Quality of Life Outcomes in Patients With Simultaneous Pancreas-Kidney Transplants
Official title: Measurement of Patient Reported Gastrointestinal (GI) and Health-related Quality of Life (HRQL) Outcomes in Simultaneous Pancreas-Kidney Transplant Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pancreas Transplantation
Kidney Transplantation
Keywords: Simultaneous Pancreas-Kidney Transplantation
mycophenolate
GI problems
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-12-20
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Treatment with the immunosuppressive drug mycophenolate mofetil (MMF) may result in gastrointestinal (GI) complications in some patients. This study will assess if a switch from MMF to enteric-coated mycophenolate sodium (EC-MPS) results in improved GI and/or health-related quality of life outcomes and determine the proportion of pancreas-kidney transplant recipients who experience any GI complaints under MMF-based immunosuppressive treatment.


Eligibility criteria: Inclusion Criteria:

* Received simultaneous pancreas-kidney (SPK) transplant at least 3 months prior to study enrollment
* Receiving immunosuppressive regimen that includes MMF in combination with other immunosuppressive drugs (i.e., a calcineurin inhibitor, a mTOR inhibitor, steroids at least for three months at time of study enrollment)
* Receiving MMF for at least 1 month prior to enrollment; maximal MMF dose 2000 mg/d.

Exclusion Criteria:

* Patients with any known hypersensitivity to mycophenolic acid, mycophenolate sodium, mycophenolate mofetil or other components of the formulations (e.g. lactose; see also SCP of EC-MPS)
* If applicable, GI symptoms assumed or known to be induced by other drugs or infections (e.g. oral biphosphonates induced, infectious diarrhea)
* Acute rejection \< 1 month prior to study enrollment

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Changes in Gastrointestinal Symptom Severity and/or Health-related Quality of Life After Conversion From MMF to Enteric Coated Mycophenolate Sodium
timeFrame: weeks 6-8
Secondary outcomes:
measure: Gastrointestinal Symptoms Under MMF-based Immunosuppressive Therapy
timeFrame: week 0
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Universitätsklinikum Charité Campus Virchow Klinikum Berlin Nephrologie und Internistische Intensivmedizin
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT02596750: The Effect of Microneedle Pretreatment on Topical Anesthesia
Official title: The Effect of Microneedle Pretreatment on Topical Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2015-11-04
Enrollment: 21
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Each subject will serve as his or her own control. The right forearm and the left forearm will be randomized through a binary randomization to determine whether the right arm will receive microneedle treatment or sham microneedle treatment (roller with no microneedles). This randomization is developed through code in Excel that will result in binary result of either the value 0 or 1 for each subject. For those subjects assigned a binary code of 0, the right forearm will receive microneedle treatment and the left forearm will receive sham microneedle treatment. For those subjects assigned a binary code of 1, the left forearm will receive microneedle treatment and the right forearm will receive sham microneedle treatment.
Primary purpose: PREVENTION

Brief summary: This study evaluates the role of microneedle pretreatment in the speed at which anesthesia develops after application of topical 4% lidocaine.

Detailed description: This study evaluates whether the time to anesthesia with topical 4% lidocaine can be accelerated with the use of microneedle pretreatment. The study will evaluate the anesthesia as a randomized split-body study where each subject serves as their own control. The study will be performed on the volar forearm. Prior to application of the topical 4% lidocaine, one arm will be exposed to a microneedle pretreatment on a microneedle roller and the other arm will be exposed to sham microneedle treatment that will consist of a flat roller with no microneedles. Then pain will be assessed with the use of a spring loaded needle lancet that will be applied at 2 min, 5 min, 10 min, and 30 minutes after treatment.

Eligibility criteria: Inclusion Criteria:

* Healthy volunteers

Exclusion Criteria:

* Allergy to lidocaine
* Smokers

Primary outcomes:
measure: Visual Analog Scale Pain
timeFrame: 2 min
measure: Visual Analog Scale Pain
timeFrame: 5 min
measure: Visual Analog Scale Pain
timeFrame: 10 min
measure: Visual Analog Scale Pain
timeFrame: 30 min
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California Davis
state: California
Study officials:
affiliation: UC Davis
name: Raja K Sivamani, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sivamani RK, Stoeber B, Wu GC, Zhai H, Liepmann D, Maibach H. Clinical microneedle injection of methyl nicotinate: stratum corneum penetration. Skin Res Technol. 2005 May;11(2):152-6. doi: 10.1111/j.1600-0846.2005.00107.x.
citation: Sivamani RK, Liepmann D, Maibach HI. Microneedles and transdermal applications. Expert Opin Drug Deliv. 2007 Jan;4(1):19-25. doi: 10.1517/17425247.4.1.19.
Clinical trial NCT06786650: Comparision of the Analgesic Effects of Intravenous Ibuprofen and Tenoxicam in Acute Migraine Attack
Official title: Comparision of the Analgesic Effects of Intravenous Ibuprofen and Tenoxicam in Acute Migraine Attack
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Migraine
Analgesic Affect
Emergency Medicine
Keywords: Anti-Inflammatory Agents Non-Steroidal
Acute migrane attack
Lead sponsor: Haydarpasa Numune Training and Research Hospital
Sponsor class: OTHER
First posted: 2025-01-22
Enrollment: 100
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 aim of this clinical trial is to compare the efficacy of two different non-steroidal anti-inflammatory analgesic drugs in the palliation of headache in acute migraine attack. The main questions it aims to answer are:

1. Is there a difference between the efficacy of two different nonsteroidal anti-inflammatory analgesics?
2. Is there a significant difference between the side effects of two different nonsteroidal anti-inflammatory drugs? Researchers will compare intravenous tenoxicam to intravenous ibuprofen to see if tenoxicam works to treat migraine attack.

Treatments will;

1. be administered in 100 cc saline to ensure blinding in the group.
2. Randomisation will be done by closed envelope method.
3. Numerical Pain Scale (NRS) will be used to evaluate the analgesic efficacy of the drugs. NRS scores will be recorded in both groups before starting treatment (baseline) and at 30, 60 and 120 minutes after treatment.
4. Any side effects due to medication will be recorded.


Eligibility criteria: Inclusion Criteria:

* Being between the ages of 18-65.
* Having a known diagnosis of migraine.
* Exclusion of secondary causes to explain the headache in the emergency department.
* Having migraine during a migraine attack and not having received any medical treatment for migraine before the application.

Exclusion Criteria:

* Being under 18 years of age.
* Being pregnant or breastfeeding.
* Being admitted to the emergency department with headache due to causes other than migraine (secondary).
* Being admitted with an acute migraine attack and having used medication for migraine treatment within 12 hours before admission.
* Having a history of allergy to any of the drugs to be used in the study.
* Having a history of comorbidities for which the drugs to be used in the study are contraindicated.

Primary outcomes:
measure: Achievement of pain palliation
timeFrame: NRS scores of both patient groups will be recorded at the time of admission (NRS Baseline) and at 30, 60 and 120 minutes after the treatment is given.
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Haydarpasa Numune Training and Research Hospital
state: Uskudar
Study officials:
name: Colak, Professor Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03515850: Anatomical Classifications of Inferior Mesenteric Artery
Official title: Clinical Trial of Anatomical Classifications of Inferior Mesenteric Artery in Laparoscopic Rectal Resection Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colorectal Cancer
Lead sponsor: Southwest Hospital, China
Sponsor class: OTHER
First posted: 2018-05-04
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This study is a prospective study，and based on the conjoin classifications of branches, the anticipant populations of this study is 500.

Brief summary: The vascular branches of inferior mesenteric artery (IMA) involve superior rectal artery(SRA),Sigmoid artery(SA) and the left colic artery(LCA). Different levels of ligation of the (IMA) are applied in rectal cancer surgery, including retain or not retain the left colic artery(LCA). Retained the LCA would facilitate the vascularity. The variations of vessels are more frequent in the combinations of branches, while LCA, SA and SRA may vary from people to people. Which contribute to the difficulty of surgery to retain the LCA.. As a result, a better understanding of the anatomical branches classification of IMA is a must during operation. However, existing studies of IMA's branches combination are very rare and often single-centered with minimal samples. In order to achieve better surgical outcome and reduce operative complications, the investigators design this study to investigate the anatomical classification of IMA and the surgical outcome of each type


Eligibility criteria: Inclusion Criteria:

1. Patients who undergoing laparoscopic rectal cancer surgery.
2. Pathology: adenocarcinoma or huge adenomas proven by colonoscopic biopsy.
3. Localization: tumor located between distal sigmoid colon and anal canal.
4. Patients have to be aware of the aim of the trial, and have signed the informed consent.

Exclusion Criteria:

1. History of any gastrointestinal surgery.
2. Patients with emergent surgery.

Primary outcomes:
measure: classifications vascular branches of IMA
timeFrame: 3years
Secondary outcomes:
Other outcomes:
Locations:
city: Chongqing
country: China
facility: General Surgery Center of PLA
Study officials:
References:
Clinical trial NCT06855550: Postoperative Incidence of Atrial Fibrillation Following Cardiac Surgery
Official title: Evaluation of Plasmatic Magnesium Levels and Its Association with Atrial Fibrillation After Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation (AF)
Hypomagnesemia
Cardiac Surgery
Lead sponsor: Fundación Cardioinfantil Instituto de Cardiología
Sponsor class: OTHER
First posted: 2025-03-04
Enrollment: 435
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent cardiac surgery at Fundación Cardioinfantil-Instituto de Cardiología, from May 2015 to May 2016.

Brief summary: Introduction: Postoperative atrial fibrillation is one of the most frequent complications in cardiac surgery, with an expected incidence of more than 50% following valve surgery. Hypomagnesemia is also likely to be observed in the postoperative period, and several studies have suggested that it could be related to the incidence of postoperative atrial fibrillation. In this study, via a prospective design and adjustment for multiple covariates, the investigators will seek to determine whether plasma magnesium levels are independently associated with the appearance of postoperative atrial fibrillation.

Methods: An analytical design involving a concurrent cohort will be carried out in a high-complexity hospital with a cardiovascular focus. Serial postoperative plasma magnesium measurements will be included as independent variables in a logistic regression model to determine their association with atrial fibrillation after adjusting for multiple covariates.


Eligibility criteria: Inclusion Criteria:

* Adults in postoperative cardiac surgery

Exclusion Criteria:

* Preoperative atrial fibrillation
* Without complete information regarding plasmatic magnesium postoperative measurements

Primary outcomes:
measure: Postoperative Atrial fibrilation
timeFrame: Measurement was performed first day after surgery up to 30 days postoperatively or discharge (whichever came first)
Secondary outcomes:
measure: Mortality
timeFrame: Measurement was performed first day after surgery up to 30 days postoperatively or discharge (whichever came first)
Other outcomes:
Locations:
city: Bogotá
country: Colombia
facility: Fundación Cardioinfantil-Instituto de Cardiología
state: Bogotá D.C
Study officials:
References:
Clinical trial NCT06394050: Label-free Raman Spectroscopy for Discrimination Between Breast Cancer Tumor and Adjacent Tissues After Neoadjuvant Treatment
Official title: Utilizing Label-free Raman Spectroscopy for Discrimination Between Breast Cancer Tumor and Adjacent Tissues in Patients After Neoadjuvant Treatment
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Diagnosis
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2024-05-01
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with local advanced breast cancer who had completed surgery after neoadjuvant therapy from Renji Hospital, School of Medicine, Shanghai Jiao Tong University.

Brief summary: After neoadjuvant therapy, the primary lesion in breast cancer patients may experience tumor regression, which increases the difficulty of distinguishing between breast cancer and adjacent tissues. Raman spectroscopy is a form of scattering spectroscopy, which offers rapid and sensitive analysis, delivering detailed biochemical information and molecular signatures of internal molecular components within the sample. This study aims to discern between cancer and adjacent tissues after neoadjuvant therapy in breast cancer patients using label-free Raman spectroscopy.


Eligibility criteria: Inclusion Criteria:

* (1) aged ≥ 18 years; (2) histologically confirmed invasive breast cancer (clinical tumor stage T1 to T4, nodal stage N1-3, and metastasis stage M0); (3) previous treatment with neoadjuvant chemotherapy with or without target therapy (such as trastuzumab, pertuzumab), or endocrine therapy; (4) enough frozen samples of breast cancer tumor and adjacent tissue.

Exclusion Criteria:

* (1) undergoing sentinel lymph node biopsy with indocyanine green dye or methylene blue injection after neoadjuvant therapy; (2) Breast cancer during pregnancy and lactation, inflammatory breast cancer.

Primary outcomes:
measure: Diagnostic performance
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Vanna R, Morasso C, Marcinno B, Piccotti F, Torti E, Altamura D, Albasini S, Agozzino M, Villani L, Sorrentino L, Bunk O, Leporati F, Giannini C, Corsi F. Raman Spectroscopy Reveals That Biochemical Composition of Breast Microcalcifications Correlates with Histopathologic Features. Cancer Res. 2020 Apr 15;80(8):1762-1772. doi: 10.1158/0008-5472.CAN-19-3204. Epub 2020 Feb 24.
Clinical trial NCT02022150: Body Composition Analysis in Cirrhotic Undergoing Paracentesis
Official title: Body Composition Analysis in Cirrhotic Patients With Ascites Undergoing Paracentesis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Liver Cirrhosis
Ascites
Keywords: Paracentesis
Liver Cirrhosis
ascites
body composition
Lead sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Sponsor class: OTHER
First posted: 2013-12-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The cohort will be selected from the Liver Clinic, Department of Gastroenterology at a tertiary care center in Mexico

Brief summary: Ascites is a frequent complication of liver cirrhosis, initial treatment consists on diuretics intake, however, as the disease progresses this complication becomes more severe, consequently other therapeutic options are used.

Paracentesis is indicated when severe ascites is present and it should be accompanied by albumin infusion.

Nutritional status is generally affected in patients with liver cirrhosis, even more patients with severe ascites show decreased energy intake due to gastric compression.


Eligibility criteria: Inclusion Criteria:

* Any genre.
* Age 18-70 years old.
* Diagnosis of liver cirrhosis of any etiology (documented by clinical, biochemical, radiological and / or biopsy.
* Presence of high volume ascites
* The signing of informed consent will be required for the inclusion of any patient.

Exclusion Criteria:

* Hepatic encephalopathy grade III or IV. 2) liver transplantation.
* Congestive heart failure.
* Hemodialysis.
* Acute or chronic renal failure.
* Nephrotic syndrome with protein loss.
* Alcoholism active in the last 6 months.
* Pregnancy.
* upper gastrointestinal bleeding.

Primary outcomes:
measure: Body composition
timeFrame: Baseline and 8 days post treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Mexico city
country: Mexico
facility: Instituto Nacional de Ciencias Médicas y Nutrición "Salvador Zubirán"
state: D.F
city: Mexico city
country: Mexico
facility: Instituto Nacional de Ciencias Médicas y Nutrición "Salvador Zubirán"
Study officials:
affiliation: Instituto Nacional de Nutrición y Ciencias Médicas "Salvador Zubirán"
name: Aldo Torre, M.D, M.Sc.
role: PRINCIPAL_INVESTIGATOR
References: