louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02898974: Medical Marijuana and Its Effects on Motor Function in People With Multiple Sclerosis
Official title: Medical Marijuana and Its Effects on Motor Function in People With Multiple Sclerosis: An Observational Case-control Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Lead sponsor: Colorado State University
Sponsor class: OTHER
Collaborators: name: William R. Shaffer, M.D.
First posted: 2016-09-13
Enrollment: 22
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults diagnosed with Multiple Sclerosis.

Brief summary: Medical marijuana is commonly prescribed people with Multiple Sclerosis (MS) for symptom, e.g. spasticity and pain, management. Unfortunately not much is known about its effects outside the treatment for these 2 symptoms. Several previous studies have suggested people with MS using medical marijuana have lower levels of physical disability and improved walking abilities. A major limitation of these previous studies is that the investigators used subjective measures of motor function. In this proposed observational case-control study the investigators plan to objectively measure multiple domains of motor function, such as: fatigue, strength, and walking ability. No marijuana will be brought on to campus or given to participants.

Detailed description: To investigate the effects of medical marijuana usage on physical function the investigators will employ an observational case-control design. Cases (MS medical marijuana users) will be compared to age, sex, and disease duration matched controls (MS non-cannabis users).

Eligibility criteria: Inclusion Criteria:

* Medically diagnosed with MS,
* 30-60 years of age,
* Moderate disability (Patient Determined Disease Steps score 2-6).

Exclusion Criteria:

* Relapse with the last 60 days,
* High risk for cardiovascular disease (American College of Sports Medicine risk classification),
* Changes in disease modifying medications within the last 45 days,
* Concurrent neurological/neuromuscular disease,
* Hospitalization within the last 90 days,
* Inability to understand/sign informed consent.

Primary outcomes:
measure: Fatigue
timeFrame: Through study completion, an average of 6 months.
measure: Muscle Strength
timeFrame: Through study completion, an average of 6 months.
measure: Postural Stability
timeFrame: Through study completion, an average of 6 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Collins
country: United States
facility: Department of Health and Exercise Science
state: Colorado
Study officials:
affiliation: Colorado State University
name: Thorsten Rudroff, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00378274: Descriptive Study of Pain, Anxiety and Depression
Official title: Pain, Anxiety and Depression in Chronic Pain Patients With and Without Neuropathic Pain Compared With Healthy Volunteers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain
Keywords: Neuropathic pain
Chronic pain
Depression
Anxiety
Lead sponsor: Danish Pain Research Center
Sponsor class: OTHER
First posted: 2006-09-19
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE

Brief summary: The purpose of the study is to investigate pain, anxiety and depression in chronic pain patients with and without neuropathic pain compared with healthy volunteers

Detailed description: Primary outcome measures:

* Symptom checklist 92

Secondary outcome measures:

* Hamilton Depression and Anxiety Rating Scale
* Major Depression Inventory
* GAD-10 Anxiety Scale
* Health Survey SF-36
* McGill Pain Questionnaire
* Sweat test
* Heart rate variability testing
* Coping Strategy Questionnare
* Quantitative sensory testing
* Pain Catastrophizing Scale
* Pain rating (VAS)
* Interview

Eligibility criteria: Inclusion Criteria:

* Neuropathic pain patient or patient with fibromyalgia
* Daily pain in more than 6 months
* Weekly average pain score 4 or more (VAS)

Exclusion Criteria:

* Treatment with antidepressants, anticonvulsants or any other pain medication except paracetamol
* Serious or unstable medical disease
* Prior or present diagnosis of mania, bipolar or psychotic disorder, delirium, suicidal, drug and alcohol dependence, severe agitation
* Patients who cannot cooperate and do not understand Danish

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Danish Pain Research Center, Aarhus University Hospital
Study officials:
affiliation: Danish Pain Research Center, Aarhus University Hospital
name: Lise Gormsen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06083974: Metastatic Left Colon and Rectal Cancer Treatment With Anti_EGFR Targeted Therapy
Official title: Retrospective Study of Metastatic Left Colon and Rectal Cancer as Regard Treatment With Anti_EGFR Targeted Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Colorectal Adenocarcinoma
Keywords: EGFR, Targeted therapy ,metastatic colorectal cancer
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-10-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with left colon and rectum cancer of stage four received target therapy anti_EGFR targeted therapy

Brief summary: Colorectal cancer ranks the second lethal cancer and third prevalent malignant tumour worldwide, Despite of different odern modalities for diagnosis,large number of cases diagnosed at metastatic advanced stage .

New treatment approach has been discovered habe been discovered making a huge revolution in metastatic colorectal cancer represented by targeted therapy including anti_EGFR ,anti_angiogenic and kinase inhibitors .

Detailed description: Retrospective study aims to evaluate the effect of EGFR expression in metastatic colorectal cancer and the outcome of treatment with anti_EGFR targeted therapy between left colon and rectal cancer

Eligibility criteria: Inclusion Criteria:

1. age above 18
2. Both sex
3. Performance status zero to one according to ECOG scale system
4. Histo-pathologial diagnosis adenocarcinoma of left colon or rectum.
5. Patients diagnosed with left colon and rectal cancer.
6. Patients eligible to receive chemotherapy (with renal and liver chemistry, and normal CBC.
7. Patients diagnosed with metastatic stage.
8. K-RAS wild type.

Exclusion Criteria:

1. Second malignancy
2. Histo-pathological types other than adenocarcinoma.
3. Right colon cancer patients.
4. Patients refused receiving anti_EGFR targeted therapy.
5. Patients with any abnormalities preventing to receive chemotherapy.
6. Early stages of colorectal cancer.
7. K-RAS mutant type.

Primary outcomes:
measure: OS and DFS of patients with metastatic colorectal cancer patients received anti_EGFR targeted therapy
timeFrame: Anti_EGFR targeted therapy in assuit university hospitals from 2015 to 2022
Secondary outcomes:
measure: Response rate (RR) in patients received chemotherapy only or with combination with targeted therapy.
timeFrame: The response of patients to EGFR targeted therapy in AUH at period from 2015 to 2022
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Samir E Shehata, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT01367574: Methylnaltrexone in Patients With Opioid-Induced Bowel Dysfunction
Official title: A Phase II Double-Blind, Randomized, Parallel Group, Dose Ranging Study of Subcutaneous Methylnaltrexone in Patients With Opioid-Induced Bowel Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Bowel Dysfunction
Keywords: Opioid-induced bowel dysfunction
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
First posted: 2011-06-07
Enrollment: 39
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: This is a double-blind, randomized, parallel group, dose ranging study of subcutaneous methylnaltrexone to be conducted in patients with advanced medical illness and poorly controlled opioid induced constipation. Patients will be randomized to one of three fixed dose levels of SC MNTX.


Eligibility criteria: Inclusion Criteria:

1. Must have advanced medical illness (cancer, HIV, etc) and be receiving palliative care
2. Must be on opioid medication for at least 2 weeks with no expectation of significant change in regimen
3. Must have constipation
4. Must be 18 yrs or older

Exclusion Criteria:

1. Concurrent use of medications other than opioids which might interfere with gastrointestinal motility
2. Patients who received any experimental drug in the last 30 days
3. Patients with active peritoneal cancer (ovarian, etc.)
4. Patients with active diverticulitis or diverticulosis

Primary outcomes:
measure: Number of subjects who have a bowel movement within four hours of dosing
timeFrame: Up to 4 weeks
Secondary outcomes:
measure: Number of subject with Adverse Events
timeFrame: Up to 4 weeks
Other outcomes:
Locations:
city: Tarrytown
country: United States
facility: Progenics Pharmaceuticals, Inc.
state: New York
Study officials:
affiliation: Progenics Pharmaceuticals, Inc.
name: Tage Ramakrishna, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03216174: Pilot Study of Non-exposure Simple Suturing EFTR With Sentinel Lymph Node Navigation for EGC (Senorita3-pilot)
Official title: Pilot Study of Non-exposure Simple Suturing EFTR (NESS-EFTR) With Sentinel Lymph Node Navigation for Early Gastric Cancer (Senorita3-pilot)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Early Gastric Cancer
Lead sponsor: National Cancer Center, Korea
Sponsor class: OTHER_GOV
First posted: 2017-07-13
Enrollment: 20
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: Laparoscopic sentinel lymph node dissection and stomach preserving surgery in early gastric cancer is less invasive method which can increase quality of life. Current stomach preserving surgery after sentinel lymph node dissection produce transmural communication and expose the tumor to the peritoneum during operation. An endoscopic full-thickness resection method with a simple suturing technique that does not expose the gastric mucosa to the peritoneum (non-exposure simple suturing, NESS) was recently developed.

This is the pilot study to prove the feasibility of NESS-EFTR with sentinel node navigation in early gastric cancer patients.


Eligibility criteria: Inclusion Criteria:

* single lesion of adenocarcinoma in preoperative endoscopic biopsy
* clinical stage T1N0 in the preoperative evaluation of endoscopy and computed tomography
* tumor size: less than 3cm in differentiated type, less than 2cm in undifferentiated type
* location: 2cm far from the pylorus or cardia
* aged 20 to 80
* ECOG 0 or 1
* patient who signed the agreement
* patient who is suspected to underwent laparoscopy assisted gastrectomy

Exclusion Criteria:

* indication of endoscopic submucosal resection
* inoperable due to poor cardiac, pulmonary function
* pregnant
* having allergic reaction, previous upper abdominal surgery except laparoscopic cholecystectomy, previous radiation therapy to upper abdomen
* diagnosed as malignancy within 5 years except carcinoma in situ of cervix cancer and thyroid cancer

Primary outcomes:
measure: Complete resection
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Goyang
country: Korea, Republic of
facility: National Cancer Center
state: Gyeonggi
Study officials:
affiliation: National Cancer Center
name: Chan Gyoo Kim, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Eom BW, Kim CG, Kook MC, Yoon HM, Ryu KW, Kim YW, Rho JY, Kim YI, Lee JY, Choi IJ. Non-exposure Simple Suturing Endoscopic Full-thickness Resection with Sentinel Basin Dissection in Patients with Early Gastric Cancer: the SENORITA 3 Pilot Study. J Gastric Cancer. 2020 Sep;20(3):245-255. doi: 10.5230/jgc.2020.20.e22. Epub 2020 Jul 6.
Clinical trial NCT02475174: Manual Lymphatic Drainage in the Superior Member in Women in Post-surgery for Breast Cancer
Official title: Blood Circulation Assessment of the Superior Member in Women in Post-surgery for Breast Cancer Submitted to the Manual Lymphatic Drainage
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lymphedema
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2015-06-18
Enrollment: 30
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Evaluate the effect of Manual Lymphatic Drainage (MLD) massage in arterial and venous circulation of the upper limb ipsilateral of women submitted after axillary lymphadenectomy breast cancer.

Detailed description: The aim of the study is to evaluate the effect of Manual Lymphatic Drainage (MLD) massage in arterial and venous circulation of the upper limb ipsilateral of women submitted after axillary lymphadenectomy breast cancer. Will be evaluated 30 volunteers aged between 40 and 60 years, divided into 2 equal groups, submitted at MLD: Group 1 - volunteers who underwent surgery for breast cancer that have lymphedema, subject to manual lymphatic drainage without upper limb elevation; Group 2 - volunteers who underwent surgery for breast cancer that have lymphedema, subject to manual lymphatic drainage with the upper limb elevation to 30º. Data will be collected by ultrasound Doppler in vein and brachial artery before, after MLD, immediately after, and 30 minutes after therapeutic treatment, with and without elevation of 30°, cross over delimitation, being made a therapy session for therapeutic use with and without elevation, with interval period (washout) for seven days. The order of treatment protocols will be randomized by simple raffle for each volunteer. The data within and between groups will be evaluated by a statistical test t student or ANOVA. Otherwise it will be used Kruskal-Wallis followed test by Dunn. Data processing will be performed by software and fixed the critical level of 5% (p\<0,05).

Eligibility criteria: Inclusion Criteria:

* Women with axillary lymphadenectomy surgery
* Lymphedema
* Aged 40-60 years.

Exclusion Criteria:

* Women with muscle-tendon injury and / or joint injuries member
* Skin disorders
* circulatory diseases.

Primary outcomes:
measure: Blood flow velocity (Flow velocity in brachial artery and vein)
timeFrame: one day
Secondary outcomes:
measure: Volume upper limbs
timeFrame: one day
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01687374: Parathyroid Hormone for the Treatment of Humerus Fractures
Official title: Phase IV Study of the Effect of Parathyroid Hormone on Fractures of the Humerus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Shoulder Fractures
Keywords: proximal humeral fracture
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
Collaborators: name: Takeda
First posted: 2012-09-18
Enrollment: 72
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hypothesis:

The investigators want to study whether parathyroid hormone improves healing of humerus after a fracture. The investigators will assess healing of the humerus with Constant score.


Eligibility criteria: Inclusion Criteria:

* proximal humeral fracture eligible for conservative treatment.
* able to understand the protocol
* signs an informed consent

Exclusion Criteria:

* liver disease
* kidney disease
* severe osteoporosis
* malignant disease
* bone metabolic disease
* oral treatment with bisphosphonates during the last 3 months.
* treatment with Denosumab during the last 6 months.
* intravenous treatment with bisphosphonates during the last 12 months.

Primary outcomes:
measure: Changes in constant score
timeFrame: 5, 8, 11, 23, and 104 weeks.
Secondary outcomes:
measure: Changes in Oxford Shoulder Score
timeFrame: 5, 8, 11, 23, and 104 weeks.
measure: Changes in bone formation evaluated by X-ray.
timeFrame: 5, 8, 11, 23, and 104 weeks.
measure: Changes in biochemical bone markers
timeFrame: 0, 5, 25 weeks
measure: Changes in regulatory T lymphocytes
timeFrame: 0, 8, 24 weeks
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Hvidovre Hospital
Study officials:
References:
citation: Aspenberg P, Genant HK, Johansson T, Nino AJ, See K, Krohn K, Garcia-Hernandez PA, Recknor CP, Einhorn TA, Dalsky GP, Mitlak BH, Fierlinger A, Lakshmanan MC. Teriparatide for acceleration of fracture repair in humans: a prospective, randomized, double-blind study of 102 postmenopausal women with distal radial fractures. J Bone Miner Res. 2010 Feb;25(2):404-14. doi: 10.1359/jbmr.090731.
citation: Peichl P, Holzer LA, Maier R, Holzer G. Parathyroid hormone 1-84 accelerates fracture-healing in pubic bones of elderly osteoporotic women. J Bone Joint Surg Am. 2011 Sep 7;93(17):1583-7. doi: 10.2106/JBJS.J.01379.
Clinical trial NCT01632774: Analysis of Risk Factors for Death After Blunt Traumatic Rupture of the Thoracic Aorta
Official title: Analysis of Risk Factors for Death After Blunt Traumatic Rupture of the Thoracic Aorta
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Rupture
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2012-07-03
Enrollment: 85
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Hospitalized patients Patients who died at the scene

Brief summary: Aortic injuries after blunt thoracic trauma are compared to the great incidence of accidents relatively rare, but potentially serious leading to death at scene in most of the cases. The study was undertaken to delineate mortality and its risk factors on three different levels (pre-hospital, in-hospital and overall). Between 1990 and 2003, all consecutive patients and victims with traumatic aortic rupture were retrospectively analyzed by reviewing hospital and autopsy records.

Detailed description: During the study period of 14 years (January 1990 to December 2003), all consecutive cases with traumatic rupture of the thoracic aorta being reported in the greater area of Zurich with about one million inhabitants were included in the present study. Related to the final outcome, patient data were drawn either from medical reports from the University Hospital of Zurich, which is a tertiary care teaching hospital and level I trauma center for the eastern part of Switzerland, or from autopsy reports from the Institute of Forensic Medicine of the University of Zurich, respectively. The latter group includes all patients, who died on the scene, in a assigning primary care hospital or on the way to the University Hospital of Zurich. In Switzerland, the criteria used for performing a full autopsy after a blunt traumatic death include all cases in which the events leading to the death are unclear or in which the cause of death is the result of suicide or extrinsic harm. Both, deaths at the scene and in-hospital deaths were included in the study.

Eligibility criteria: Inclusion criteria:

* During the study period of 14 years (January 1990 to December 2003), all consecutive cases with traumatic rupture of the thoracic aorta being reported in the greater area of Zurich with about one million inhabitants were included in the present study

Exclusion criteria:

* Non-traumatic aortic rupture
* Non-traumatic aortic dissection

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Division of Internal Medicine
state: ZH
Study officials:
affiliation: University Hospital Zurich, Division of Internal Medicine
name: Daniel Franzen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Franzen D, Genoni M. Analysis of risk factors for death after blunt traumatic rupture of the thoracic aorta. Emerg Med J. 2015 Feb;32(2):124-9. doi: 10.1136/emermed-2013-202639. Epub 2013 Sep 4.
Clinical trial NCT02904174: Healthy Living Programme for Older Adults
Official title: Healthy Living Programme (HLP): Diet, Drug and Fall Prevention for Community-dwelling Frail Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frail Older Adults
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
Collaborators: name: Pentecostal Church of Hong Kong
First posted: 2016-09-16
Enrollment: 122
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Malnutrition, risk of falls and medication incidents are commonly faced by the older adults. This study aimed to provide health education to community-dwelling older adults and to assess the effectiveness of a Healthy Living Program (HLP) to older adults in terms of fall prevention, drug management and healthy eating habits.

Detailed description: This was a single group pre-post trial. Participants aged 60 or above were recruited from the community elderly centres. A 6-week HLP, which included one 45 minutes weekly session, was offered to the participants.

122 participants were recruited. This study shows that the 6-week HLP has a potential to improve the physical well-being of the participants, and to increase their knowledge in diet, drug management and fall prevention.

Eligibility criteria: Inclusion Criteria:

* able to communicate and understand Cantonese
* \> 1 in frailty score
* members of the Pentecostal Church of Hong Kong

Exclusion Criteria:

* nil

Primary outcomes:
measure: Change in subjective happiness level
timeFrame: Baseline, Week 6
Secondary outcomes:
measure: Change in frailty status
timeFrame: Baseline, Week 6
measure: Change in pain intensity
timeFrame: Baseline, Week 6
measure: Change in Generalized pain self-efficacy beliefs
timeFrame: Baseline, Week 6
measure: Change in functional mobility
timeFrame: Baseline, Week 6
measure: Change in hand grip strength
timeFrame: Baseline, Week 6
measure: Change in knowledge in healthy eating habits
timeFrame: Baseline, Week 6
measure: Change in knowledge in drug management
timeFrame: Baseline, Week 6
measure: Change in knowledge in fall prevention
timeFrame: Baseline, Week 6
Other outcomes:
Locations:
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Mimi Mun Yee Tse, PhD
role: PRINCIPAL_INVESTIGATOR
References: