cyrilzakka/clinical-trials huggingface dataset:
Effect of Custom Dynamic Orthoses on Forefoot Loading

The proposed study is designed to evaluate how foot loading changes during initial accommodation to a carbon fiber custom dynamic orthosis (CDO), after targeted training with or without visual feedback of foot loading, and after take-home use of the CDO. This study will quantify initial offloading associated with CDO use and determine if visual feedback of foot loading and additional take-home use of the CDO can further reduce forces, as orthotists work to provide CDOs to patients.

This study is designed to evaluate the effects of initial accommodation, CDO related training, and take-home use on foot loading during gait. In this study, adult participants who experienced an injury below the knee and require a CDO will walk without the CDO, then with the CDO following initial prescription, after training with or without visual force feedback, and after additional take-home use of the CDO. Participants will be randomized to to training with or without visual feedback of foot loading forces.

Wireless force measuring sensors will be used to measure forces under the foot with and without the CDO at each time point. Participants will complete questionnaires to assess and compare various patient outcomes (e.g. pain, quality of life, comfort, satisfaction, and preference).

Eligibility Criteria:
Patient Inclusion criteria

* Ages: 18-65
* Sustained a function limiting injury below the knee, requiring a carbon fiber custom dynamic orthosis
* Shoe size between women's 8 and 13.5 or men's 6.5 and 13
* Any of the following: weakness of ankle plantarflexors (\<4/5 on MMT), limited pain free ankle motion (DF\<10deg or PF\<20deg), mechanical pain with loading onto hindfoot/midfoot/forefoot (\>4/10 on verbal numeric pain rating scale), ankle or hindfoot fusion, candidate for ankle or hindfoot fusion, candidate for amputation secondary to ankle/foot impairment
* Ability to walk 25 feet without using a cane or crutch
* Ability to walk at a slow to moderate pace
* Able to read and write in English and provide written informed consent

Patient Exclusion criteria

* Pain \> 9/10 while walking
* Ankle weakness as a result of spinal cord injury or central nervous system pathology
* AFO or CDO prescription that includes a knee brace or goes up to thigh
* Medical or psychological conditions that would preclude functional testing (ex. severe traumatic brain injury, heart condition, clotting disorder, lung condition, stroke, vestibular disorder)
* Nerve, muscle, bone, or other condition limiting function of the contralateral extremity
* BMI greater than 40
* Visual or hearing impairment that limit walking ability or limit the ability to comply with instructions given during testing
* Pregnancy
Impact of E-cigarette Characteristics on Reinforcement and Tobacco Use Patterns

The purpose of this project is to understand how different e-cigarettes influence their likeability and use among current smokers who try using e-cigarettes. Participants will receive an e-cigarette to sample over a three week period. During this time period they will complete daily electronic diaries and weekly lab visits. The results from this information will help understand how different types of e-cigarettes are likely to influence cigarette and e-cigarette use.


Eligibility Criteria:
Inclusion criteria include

* adults who have been smoking daily
* interested in using e-cigarettes
* who have a smartphone that can receive text messages and access to the internet or has an e-mail account that they check daily

Exclusion criteria include

* minimal prior e-cigarette use
* use of tobacco products other than cigarettes
* current use of cessation medications
* pregnant, trying to become pregnant, or breastfeeding,
* recent history of cardiovascular distress in the last three months (e.g., arrhythmia, heart attack, stroke, uncontrolled hypertension),
* household member currently enrolled in the study.
Effects of Administration of Fostamatinib on Blood Concentrations of Digoxin in Healthy Subjects

The purpose of this study is to investigate the drug interaction between fostamatinib and digoxin by comparing the safety, tolerability and plasma concentration of digoxin when administered alone and with fostamatinib in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Provision of informed consent prior to any study specific procedures
* Male or female subjects aged 18 to 45 years (inclusive)
* Minimum weight of 50 kg and body mass index (BMI) between 18 and 30 kg/m2 (inclusive)
* Female subjects must have a negative pregnancy test at screening and on Day -1,must not be lactating, and must be of non-childbearing potential

Exclusion Criteria:

* History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs (except for cholecystectomy)
* Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of the investigational product
* Subjects who smoke more than 5 cigarettes or the equivalent in tobacco per day
* Absolute neutrophil count of \<2500/mm3 or 2.5 x 109/L
* Previous treatment with fostamatinib or digoxin in the present study
Monitoring HDR Brachytherapy for Cervical Cancer by Optic and Thermal Imaging

This research aims to investigate the correlation between tumor temperature difference and biological factors, such as size, metabolism, treatment response, and tumor aggressiveness.

In addition, normal tissue response to radiation therapy in treated organ will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* signed informed consent
* biopsy proven cervical cancer which will undergo definitive radiation

Exclusion Criteria:

* not eligible to sign informed consent
Observational Study of Vectibix With Chemotherapy for Metastatic Colorectal Cancer Patients

The primary objective was to describe the pattern of use of panitumumab (Vectibix®) in combination with chemotherapy in patients with wild-type rat sarcoma viral oncogene homolog (RAS) metastatic colorectal cancer (mCRC): as first-line treatment in combination with FOLFOX or FOLFIRI or second-line treatment in combination with FOLFIRI in patients who have received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan).


Eligibility Criteria:
Inclusion Criteria

* Subject is ≥ 18 years of age at date of enrolment
* Histologically or cytologically confirmed carcinoma of colon or rectum
* Subject with metastatic carcinoma of colon or rectum
* Confirmed wild-type RAS status of tumour
* Subjects whose care will be managed primarily by the enrolling physician and/ or all records will be available
* Tumour assessment (ie, computed tomography \[CT\]/magnetic resonance imaging \[MRI\]) within 12 weeks (84 days) prior to first Vectibix® infusion.
* Subjects treated with at least one infusion of Vectibix® in combination with chemotherapy a maximum of 84 days before entering study: first-line in combination with FOLFOX (folinic acid, leucovorin, fluorouracil \[5FU\], oxaliplatin) or second-line in combination with FOLFIRI (folinic acid, leucovorin, 5FU, irinotecan) in subjects who have received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan) for treatment of wild-type RAS mCRC per approved prescribing information
* Subject or subject's legally acceptable representative has provided informed consent (for countries where required per local regulations)
* Subjects treated with Vectibix® in accordance with the current version of the Summary of Product Characteristics (SmPC)

Exclusion Criteria

* Ongoing or planned concurrent participation in any clinical study involving Investigational Product that has not been approved by the European Medicines Agency for any indication
* Ongoing or planned concurrent participation in any clinical study where the dosing of Vectibix® is determined by the protocol (participation in clinical trials on an approved drug and observational trials are permitted but these cannot mandate how mCRC should be treated)
Investigation of Correlation Between Interstitial and Arterial Blood Glucose Concentrations in Septic Patients

This is a mono-centre trial performed at the medical ICU at the Medical University Graz. There will be a study visit (V1) and a follow-up assessment (V2). In the study visit (V1) arterial blood glucose values will be monitored and subcutaneous sampling of interstitial fluid (ISF) with microdialysis for glucose determination and with microperfusion for cytokine-measurement will be performed. The study visit will last for 26 hours starting with the insertion of two catheters in the abdominal subcutaneous tissue (one microdialysis- and one microperfusion catheter). The primary hypothesis of the study is: Interstitial fluid glucose concentration profiles correlates to the arterial blood glucose concentration profile in patients with severe sepsis in the medical ICU.


Eligibility Criteria:
Inclusion Criteria:

* Patients in the medical ICU fulfilling criteria for severe sepsis
* Mechanical ventilation
* Increased blood glucose levels ( \> 120 mg/dL; \> 6.7 mM), or requiring insulin treatment.
* Age of patients in the range from 18 to 90 years.

Exclusion Criteria:

* Any disease or condition which the Investigator or the treating physician feels would interfere with the trial or the safety of the patient
Non-steroidal Anti-inflammatory Drugs (NSAIDs) and Risk of Acute Kidney Injury in Patients With Heart Failure

The purpose of this study is to evaluate whether non-steroidal anti-inflammatory drugs (NSAIDs) were associated with acute kidney injury (AKI) in patients with heart failure. In addition, the investigators would like to assess the risk of admission for acute decompensated heart failure following exposure to NSAIDs within 30 days.


Eligibility Criteria:
Inclusion criteria

1. Patient's age was more than 20 years old
2. Diagnosis of heart failure
3. With prescription of NSAIDs (only oral and intravenous form are included)

Exclusion criteria

1. With prescription of NSAIDs administered by topical use
2. Patient was pregnant
The Relationships Between Gene Polymorphisms of LTA4H and Dexamethasone Treatment for Tuberculous Meningitis

The study aimed to evaluate the relationships between the gene polymorphisms of leukotriene A4 hydrolase(LTA4H) and Dexamethasone treatment for tuberculous meningitis in Chinese patients.


Eligibility Criteria:
Inclusion Criteria:

patients were eligible to enter the study if they met the diagnositic criteria for possible, probable or definite Tuberculosis meningitis(TBM).

Exclusion Criteria:

Patients were excluded if they were infected with HIV, diagnosed as carcinomatous meningitis, viral meningitis, purulent meningitis, cryptococcus meningitis.
eHealth Literacy Workshops in the Community

This study aims to implement and evaluate an eHeath literacy workshop that trains women to take advantage of the digital media available to them so that they can use it to their advantage- set appointments, search for doctors, critically read and understand health information, search for information about medications, diseases, health habits and more.

This study aims to implement and evaluate an eHeath literacy workshop that trains women to take advantage of the digital media available to them so that they can use it to their advantage- set appointments, search for doctors, critically read and understand health information, search for information about medications, diseases, health habits and more. A three-session workshop (each session 1.5-2 hours) will take place via the web (for example -on zoom), or as a frontal workshop, (if MOH guidelines permitting due to COVID-19). The groups will have up to 20 participants, taking into account dropout rates of target population. Data will be collected at the first session, and at the last session. This program offers an interactive ehealth literacy workshop for men and women ages 45-75. The workshop, given by Pollin Center staff, will provide participants with the skills and tools to enable safe web surfing, search effectively for information, identify credible health information, as well as critically read and understand online information. It will also empower participants with the confidence and ability to use the information they access in achieving better personal health - allowing them to actively engage in their own care. Additionally, the workshop will review the basic services provided by HMO platforms, including the option to make appointments and search for other HMO services.

Eligibility Criteria:
Inclusion Criteria:

* Women and men ages 45-76
* Must be able to read and write in Hebrew
* Must have access to the internet
* Must have basic computer skills (including web surfing, information searching, and basic website navigation skills).

Exclusion Criteria:

- Women and men who don't meet the above criteria.
Feasibility and Impact of a Tele-rehabilitation Program in Patients With Chronic and Non-specific Neck Pain

Chronic neck pain has a high prevalence in developed countries, being one of the main causes of years lived with disability and deterioration of the quality of life. Telerehabilitation is presented as a resource capable of favoring, with its development and implementation, the transition to a universal and quality health service. The main objective of the study is to assess the change in disability produced by a telerehabilitation program (applied in the intervention group) in patients with chronic and nonspecific neck pain compared to the recommendation of home exercises (control group).

The study that will be carried out will be a controlled and randomized clinical trial (ECCA), single-blind, longitudinal and prospective with two groups (intervention group and control group). The main study variables that are intended to be analyzed pre and post intervention are disability, quality of life, pain, adherence, and depression and anxiety.

The study will take place between June 2020 and May 2021 in specialized physiotherapy clinics.


Eligibility Criteria:
Inclusion Criteria:

* People between 18 and 65 years of age
* Neck pain of more than 3 months of evolution
* Access and knowledge in the use of the internet
* Complete the informed consent

Exclusion Criteria:

* Previous trauma to the cervical region (such as whiplash)
* Neck surgery
* Osteoporosis
* Arthritis
* Cervical radiculopathy associated with externalized cervical hernia
* Vertigo or vertebrobasilar insufficiency
* Cancer
* Vertebral fracture
* Fibromyalgia
* Cognitive impairment
* Psychiatric disorders.
Efficacy and Safety of Celecoxib Versus Ibuprofen in the Treatment of Osteoarthritis of the Knee (United States)

To compare the efficacy and safety of celecoxib versus ibuprofen in subjects with osteoarthritis (OA) of the knee.


Eligibility Criteria:
Inclusion Criteria:

* Aged \>= 40 years old
* Diagnosed with OA of the knee according to the American College of Rheumatology and OA in flare state at baseline visit
* Functional capacity class of I-III

Exclusion Criteria:

* Inflammatory arthritis or gout or pseudo-gout with acute flare within the past 2 years (subjects with fibrositis or fibromyalgia will not be excluded)
* Acute joint trauma at index joint within the past 3 months with active symptoms
* Score of \>=20 on PHQ-9 or score of \>=1 on PHQ-9 item i
* Use of mobility assisting device for \<6 weeks or use of walker
Brain Enhancement Training Towards Elders Resilience to Aging

This study is a parallel arm, double-blind, randomized, controlled clinical trial to assess the efficacy of an experimental software program designed to improve cognitive functions versus a computer-based software control. Both the study and the software being investigated meet the criteria of Non-Significant Risk.

The primary objective of this study is to evaluate the effects of the experimental treatment (cognitive training) further outlined in this protocol on the cognitive abilities (e.g., processing speed, attention, working memory, and executive function), brain functionality, functional status and quality of life of individuals with age-related cognitive decline as compared to a computer-based active control.

Eligibility Criteria:
Inclusion Criteria:

* Participant must be 65 years of age or older
* Participant must be a fluent English speaker
* Participant must have adequate sensorimotor capacity to perform the program, including visual capacity adequate to read from a computer screen at a normal viewing distance, auditory capacity adequate to understand normal speech, and motor capacity adequate to control a computer mouse
* Participant must not have evidence of dementia as indicated by the Montreal Cognitive Assessment (MoCA)

Exclusion Criteria:

* Participant with any medical illnesses, injuries or conditions predisposing to imminent functional and/or cognitive decline
* Participant requiring caregiver assistance in dressing/personal hygiene
* Participant with severe visual deficits (including visual neglect, partial field cuts, anopias) and/or severe hearing deficit that would prevent use of the computerized treatment program
* Participant with recent participation of computer-delivered cognitive training within 2 years of consent
* Participant with claustrophobia or any other contraindication to MRI scanning
* Participant with inability to complete a 1-hour MRI
* Pregnant women
* Participant with any implanted devices above the waist (e.g., cardiac pacemaker or auto-defibrillators, neural pacemaker, aneurysm clips, cochlear implant, metallic bodies in the eye or central nervous system, any form of wires or metal devices that may concentrate radio frequency fields)
* Participants with active suicidal ideation with specific plan and intent or suicide-related behaviors within 2 months of consent as measured by the Columbia-Suicide Severity Rating Scale (C-SSRS)
The Impact of Working Night Shifts on Cardiac Autonomic Nervous Regulation During the Six-minute Walk Test in Nurses

To evaluate changes in heart rate variability (HRV) after the six-minute walk test (6MWT) in nurses following a night shift and explore the impact of night shift work on the regulation of the autonomic nervous system in the heart.

Thirty-five female nurses, with a mean age of 28.7 years (range 21.0-37.0 years), participated in this study. On the first and second mornings after a night shift, the nurses performed the 6MWT. During the test, electrocardiogram (ECG) signals, blood pressure, and walking distance were recorded simultaneously.


Eligibility Criteria:
Inclusion Criteria:

* Female nurses aged ≥ 18 years who had undergone annual physical examinations, did not have serious cardiopulmonary diseases, and were able to walk normally were considered for inclusion in the study.

Exclusion Criteria:

* (ⅰ) having children at home who require night care; (ⅱ) current pregnancy; (ⅲ) engaging in activities that significantly impact heart rate, such as sexual activity, 24 hours before and 24 hours after working night shifts; (ⅳ) history of thyroid dysfunction, hypertension, diabetes, coronary heart disease, etc.; (ⅴ) experiencing upper respiratory tract infection, fever, cough, diarrhea, or other illnesses within 1 week before the planned enrollment; (ⅵ) consuming coffee or strong tea, smoking, drinking alcohol, or using other substances that affect heart rate 3 days before the planned enrollment; (ⅶ) taking β-receptor blockers, sleeping pills, psychotropic drugs, or other medications that affect heart rate; and (ⅷ) judged by the investigator to be unsuitable for participation in this study.
Stilnox Treatment in Elderly Patients With Insomnia

Primary objective:

1. To evaluate the efficacy of Zolpidem 5mg for 1 week in elderly patients with insomnia in China

Secondary objectives:

1. To evaluate the safety of Zolpidem 5mg for 3 weeks in elderly patients with insomnia in China.
2. To evaluate the efficacy of Zolpidem 5mg for 3 weeks in elderly patients with insomnia in China


Eligibility Criteria:
Inclusion Criteria:

* Primary out-patient insomniac patient defined by DSM-IV criteria
* Insomnia history lasted at least 3 months , this history must include a self-reported usual sleep latency of 30 minutes or more and either 3 or more awakenings per night on average or a usual total sleep time of ≤6.5 hours

Exclusion Criteria:

* Usage of hypnotics within the previous 1-3 weeks before inclusion depending on the half-life of the hypnotics that would affect the study effect
* Concomitant usage of other hypnotics (benzodiazepines and Non-benzodiazepines) during the course if the study.
* Concomitant usage of the following Central Nervous System active medicine : antipsychotics , antidepressants ,anxiolytics, lithium and other psychotropic drugs.
* The score of Hamilton Depression Rating Scale (HAMD-24 ) more than 17.
* The score of Hamilton Anxiety Rating Scale (HAMA-14 ) more than 14.
* Patients having known hypersensitivity to Stilnox or any of the ingredients in the products
* Patient with severe respiratory insufficiency
* Patients suffering from sleep apnoea syndrome
* Patients with known severe hepatic (risk of encephalopathy) and /or renal insufficiency, or other severe organ diseases
* Patients suffering from severe myasthenia gravis
* Patients with the previous history of drug abuse, drug dependence and drug addiction
* Any other disease state or major psychiatric condition that might affect study result

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Phase II Trial of RAD001 in Refractory Colorectal Cancer

Single center open-label study of an oral agent (RAD001) in subjects with metastatic colorectal cancer refractory to at least 2 standard chemo/biologic regimens.

Study is completed and closed.

Eligibility Criteria:
Inclusion Criteria:

* Metastatic colorectal cancer refractory to at least 2 chemo/biologic regimens
* Measurable disease
* ECOG 0-2

Exclusion Criteria:

* CNS disease
* Chemotherapy or radiotherapy \< 4 weeks prior
* Active bleeding diathesis
The Effect of Oxytocin on Gastric Emptying

The investigators have seen that oxytocin lowers satiety in healthy subjects. Patients with dyspepsia suffers from decreased accommodation and increased satiety postprandially. The investigators now want to examine whether oxytocin may diminish symptoms in these patients.

Patients will come twice for a slow satiety drinking test. Once they will get saline infusion and once oxytocin 40 mU/min. At the same time they register satiety on a VAS scale.

Eligibility Criteria:
Inclusion Criteria:

* Dyspepsia

Exclusion Criteria:

* Age \> 65 years
* Cardiac disease