cyrilzakka/clinical-trials huggingface dataset:
A Targeted Strengthening Program Following Total Hip Replacement.

Total Hip Replacement (THR) is a common surgical procedure performed in people with hip osteoarthritis and appears to be effective in relieving pain and improving function. However significant wasting and weakness of the hip and knee muscles persists post-operatively. Although relief of pain and improvement of function are important outcomes following THR, weakness of the hip and knee muscles reduces a person's ability to manage stairs, slopes, public transport and results in persistent gait abnormalities. Since lower limb weakness is one of the risk factors for falls, it is important that patients undergo a strengthening program post-operatively. The hypothesis is that lower limb strength and function will be better in patients who undergo a strengthening program post-operatively than in those who have usual care.

Total Hip Replacement (THR) is a common surgical procedure performed in people with hip osteoarthritis and appears to be effective in relieving pain and improving function. However significant quadriceps atrophy and weakness persist post-operatively. Although relief of pain and improvement of function are important outcomes following THR, weakness of the hip and knee muscles reduces a person's ability to manage stairs, slopes, public transport and results in persistent gait abnormalities. Since lower limb weakness is one of the risk factors for falls, it is important that this is appropriately addressed.

The study examines the effect of an eight-week task-specific strengthening program on lower limb function in patients following THR in a randomized controlled trial. The experimental program is being conducted as a circuit in a gymnasium environment. Changes on specific measures of physical function of patients in the Experimental Group will be compared with those of patients in a Control Group who will continue with the standard care program provided at Austin Health.

Outcome measures include:lower limb muscle strength using a step test, pain, stiffness, and function as reported on the WOMAC questionnaire, quality of life using the AQoL questionnaire, the Timed Up-and-Go test. Walking tests will also be conducted. These include:

1. Walking pattern, recorded on an instrumented mat
2. Walking endurance measured by the 6-minute walk test.
3. Analysis of hip joint torques using 3-D motion analysis.

Eligibility Criteria:
Inclusion Criteria:

* primary uncomplicated total hip joint replacement 6-8 weeks prior to enrolment.
* able to walk 45m independently with or without walking aid.
* able to comprehend instructions
* prior joint replacement on the other side at least 12 months previously

Exclusion Criteria:

* unable to fully weight-bear on affected limb
* pre-existing neurological or orthopaedic condition affecting gait
* revision surgery
* post-operative complications, e.g. wound infection
* uncontrolled systemic disease
Post-Stroke Walking Speed and Community Ambulation Conversion Study

The purpose of this randomized, controlled study is to collect performance data on the ability of an investigational device designed to digitally deliver Rhythmic Auditory Stimulation to improve walking speed in people who suffered a stroke greater than six (6) months in the past and who are limited in mobility outside the home. The primary outcomes will be the mean change in walking speed (meters per second) and mean percent change in walking speed as determined by a 10-meter Walk Test after five weeks of intervention and compared between groups.

Study participants who take part in this research study will participate in a screening visit, fifteen (15) intervention visits over approximately five weeks and a final closing visit. Study participants will be assigned by chance to one of the two study groups. Participants will not be able to switch groups once they are assigned. The investigational device includes a mobile device app and sensors that are attached to shoes. Headphones and a mobile device are also required to be used and will be provided in this study.

Eligibility Criteria:
Inclusion Criteria:

1. 50 years of age and older
2. Equal to or greater than six months post-stroke
3. A comfortable walking speed greater or equal to 0.5 meters per second (m/s), but less than 0.8m/s, as determined by a 10-meter walk test.
4. Demonstrates some level of asymmetry in gait

Exclusion Criteria:

1. Has a known history of neurologic (excluding stroke) injury
2. Has had more than 2 falls in the previous month
3. Is enrolled in another walking rehabilitation intervention (e.g., physical therapy)
4. Has an external lower limb prosthetic ("artificial limb")
5. Has a hearing impairment
6. Had orthopedic surgery in the last year
7. Has severe aphasia and/or a speech/language disorder
8. Has co-morbidities that prevent participation in exercise
Cryptogenic Stroke Study

The purpose of this study is to determine whether the Sleuth Implantable Loop Recorder will enhance detection of latent atrial fibrillation in patients after cryptogenic stroke.


Eligibility Criteria:
Inclusion Criteria:

* Recent stroke (within 30 days) as defined by who has a sudden onset of focal neurological deficits presumed vascular etiology and lasting more than 24 hours.
* Negative brain image for hemorrhagic stroke
* In sinus rhythm at time of enrollment

Exclusion Criteria:

* Know history of atrial fibrillation
* Previous implanted cardiac device (ppM or ICD)
* Serious illness making it unlikely to survive one year
* Known secondary cause of stroke
Validation of the Screening Instrument: PRISMA-7 for Frailty Among Elderly Hospitalized Danes

The questionnaire PRISMA-7 was originally developed to assess frailty in community dwelling adults. The questionnaire was translated into the Danish language. This instrument was used to screen for frailty among elderly patients (75+) sent home from Nykøbing Falster Hospital after a hospital admission during the period 31. May 2017 until December 31st, 2018. PRISMA results were used to categorize each individula as frail or non-frail. The register of PRISMA results was merged with national registers on use of health serviced in order to investigate if increasing PRISMA score was associated with increasing use of health services.

Data from PRISMA scores were registered in an EasyTrial database. This database is recognized by the regional health authorities as a safe system to store individual health data. All use of the EasyTRial database is logged. The merging of data from the local EasyTRial database with data from national registries on use of health services and on mortality was permitted by the Danish National Health Data protection authorities.

Eligibility Criteria:
Inclusion Criteria:

* 75 years old persons being returned from hospital after a hospital admission and in need of further physical rehabilitation in the community

Exclusion Criteria:

Not able to give informed consent or if necessary not having a relative that can give informed consent
Free Venlafaxine Treatment for Marijuana Addiction and Depression - 1

The purpose of this study is to determine if Venlafaxine Extended Release (Ven-XR) is effective in treating individuals with marijuana addiction and depression.

Given that depression and marijuana addiction often occur together, medications to treat individuals diagnosed with both conditions may be effective. The purpose of this study is to determine the effectiveness of Ven-XR in treating individuals diagnosed with depression and marijuana addiction.

During this twelve-week, double-blind, placebo-controlled study, study visits will occur twice each week. During study visits, participants will receive either placebo or medication and provide a urine sample for drug screening. Blood tests will be collected each month and women must take pregnancy tests each month. Throughout the study, all participants will receive individualized psychotherapy sessions. At each study visit, participants will be given $5 to cover transportation costs.

Eligibility Criteria:
Inclusion Criteria:

* Meets criteria for current marijuana addiction and reports marijuana as primary drug of abuse
* Currently meets criteria for major depression or dysthymic disorder and receive a score of greater than or equal to 12 on the Hamilton Depression Inventory
* Clinically depressed for at least 3 months during a period of active marijuana use
* Women of child-bearing age will be included provided that they are not pregnant, based on the results of a blood pregnancy done at the time of screening and agree to use a method of contraception with proven efficacy and not to become pregnant during the study. To confirm this, blood pregnancy tests will be repeated monthly. Women will be provided a full explanation of the potential dangers of pregnancy while on the study. If a woman becomes pregnant, the study medication will be discontinued.

Exclusion Criteria:

* Meets criteria for past manic or psychotic disorder, unless substance-related
* History of a seizure disorder
* Individuals with chronic organic mental syndrome
* Any significant risk for suicide based on current assessment and history of attempts
* History of allergic reaction to either Venlafaxine or Ven-XR
* Unstable physical disorders that might make participation hazardous, such as uncontrolled hypertension and tachycardia (SBP\>150, DBP \>90, or a sitting quietly HR\>100), acute hepatitis (patients with chronic mildly elevated transaminase levels (\<2x upper limit of normal are acceptable) or unstable diabetes
* History of failure to respond to a previous adequate trial of Venlafaxine of at least 300 mg. for at least a 6-week period
* Physical dependence on any other drugs (excluding nicotine) that would require medical detoxification
* Currently being prescribed psychotropic medication by another physician (in the last 3 weeks), except for acute treatment of insomnia.
* Pregnant or breast-feeding
Multiple Doses of AT-1501-A201 in Adults With ALS

This is a Phase 2a, multi-center, open label, multiple dose study of AT-1501, a humanized monoclonal antibody antagonist to CD40 ligand (CD40L). Approximately 54 adults with Amyotrophic Lateral Sclerosis (ALS) will be enrolled into the study in the United States and Canada at approximately 13 ALS treatment sites.

Participants will be enrolled into one of four ascending doses.

This is a Phase 2a, multi-center, open label, multiple dose study of AT-1501, a humanized monoclonal antibody antagonist to CD40L. Approximately 54 adults with ALS will be enrolled into the study in the United States and Canada at approximately 13 ALS treatment sites.

Four ascending doses of AT-1501 will be administered as an IV infusion to sequentially enrolling cohorts. Each participant will receive 6 bi-weekly (every other week) infusions of AT-1501 over an 11-week period.

The study is estimated to take 19 weeks for participants.

Eligibility Criteria:
Inclusion Criteria:

1. ALS diagnosed as possible, laboratory supported probable, probable, or definite as defined by revised El Escorial criteria
2. ALS Functional Rating Scale - Revised (ALSFRS-R) Aggregate score of 37 or greater
3. No more than 24 months from diagnosis

Exclusion Criteria:

1. Any other central or peripheral nervous system disease that may interfere with the evaluation of ALS or its progression
2. Presence of a tracheostomy, or use of permanent assistive ventilation (ventilatory support for 23 hours per day or more)
3. History of malignancy within the previous 5 years, except for localized non-melanoma skin cancers
4. Abnormal function of the immune system resulting from:

   * Clinical conditions affecting the immune system (e.g. HIV infection, agammaglobulinemia),
   * Systemic administration of corticosteroids (PO/IV/IM) at a dose equivalent to 20 mg/day of prednisone for more than 14 consecutive days within 90 days prior to screening,
   * Administration of anti-neoplastic and/or immunomodulating agents (e.g. Tumor necrosis factor alpha (TNF α) antagonists or anti-B cell antibodies) or radiotherapy within 1 year prior to screening.
5. Recipient of Stem Cell or Gene Therapy
6. Positive test for Hepatitis B surface antigen, Hepatitis C antibody, or HIV.
7. History of deep venous thrombosis or pulmonary embolism
8. History of active substance abuse within the past 2 years
9. History of stroke, poorly controlled or significant cardiovascular disease, diabetes
Effect of Epidermal Growth Factor Receptor Inhibitors on Magnesium Homeostasis in Patients With Cancer

RATIONALE: Studying samples of blood and urine in the laboratory from patients with cancer receiving epidermal growth factor receptor inhibitors may help doctors understand the effect of epidermal growth factor receptor inhibitors on magnesium levels in the body.

PURPOSE: This laboratory study is looking at the effect of epidermal growth factor receptor inhibitors on magnesium homeostasis in patients with cancer.

OBJECTIVES:

* Determine the effects of EGFR inhibitors on magnesium homeostasis in patients with cancer.

OUTLINE: This is a pilot study.

Patients undergo blood and urine sample collection at baseline and at 2, 4, and 8 weeks during treatment.

After finishing treatment, patients are followed periodically for up to 10 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of malignancy

  * Planning to receive therapy with an inhibitor of the EGFR pathway (either on or off a clinical trial and may be monotherapy or combined with other therapies)
* Normal serum magnesium level

Exclusion Criteria:

* Glomerular filtration rate ≥ 60 mL/min
* No severe underlying renal dysfunction
* Normal serum potassium and calcium level
* No history of primary or secondary hyperparathyroidism

PRIOR CONCURRENT THERAPY:

* No prior EGFR pathway inhibitor
Evaluation of Bacillus Subtilis R0179 in Healthy Young Adults

The purpose of this study is to evaluate the effect of three doses of the probiotic B. subtilis (Bacillus subtilis R0179) delivered in capsules on gastrointestinal and general wellness in healthy young adults, survival through the gastrointestinal tract and impact on intestinal microbes.

A 6 week randomized, double blind placebo controlled trial in healthy young adults aged 18 to 50. Participants will be administered an oral dose of B. subtilis or placebo (1 capsule/day) for a period of 4 weeks. Viable counts will be measured from stool samples to assess transit survival, daily questionnaires (DQ) will be administered to assess general wellness, and gastrointestinal (GI) symptoms will be evaluated three times with the Gastrointestinal Symptom Response Scale (GSRS) questionnaire.

Eligibility Criteria:
Inclusion Criteria: Participants

* Are 18-50 years of age
* Are willing and able to complete the Informed Consent Form in English
* Are willing to complete the GPAQ (Global Physical Activity Questionnaire) at baseline and during the last week of the study as well as completing the GSRS (Gastrointestinal Symptom Response Survey) questionnaire at baseline, during treatment and post treatment
* Are currently "moderately active" as determined by the GPAQ (Global Physical Activity Questionnaire)
* Are willing to have height and weight measured and to provide demographic information (age, race, sex)
* Are willing to consume B. subtilis R0179 (approximate doses of 1, 10, or 0.1 billion CFU per day) or placebo for a 28 day period by capsule (1 per day)
* Are willing to complete daily questionnaires regarding general and gastrointestinal wellness for the duration of the study
* Are willing to provide 1 stool at baseline, 1 stool during week 4 of the treatment and 1 stool after 7 days of washout
* Are willing to provide a social security number to receive study payment. Note: the subject can still participate if unwilling to provide social security number, but no financial reimbursement can be provided
* Are willing to have internet access for the duration of the study

Exclusion Criteria: Potential Participants will be excluded if they

* Do not meet the inclusion criteria
* Are currently taking medications for constipation or diarrhea
* Have taken antibiotics within the past four weeks prior to randomization
* Are currently taking probiotics supplements and do not want to discontinue a minimum of two weeks prior to the study
* Known to have or are currently being treated for any diseases or illnesses such as gastrointestinal disease (gastric ulcers, Crohn's, ulcerative colitis, etc.), other chronic diseases (diabetes, kidney disease, etc.) or immune-compromising diseases or conditions (HIV, AIDS, autoimmune, hepatitis, cancer, transplant patient etc.)
US-guided RFA vs MWA in the Treatment of Benign Thyroid Nodules

To evaluate the clinical outcomes of RFA and MWA for benign thyroid nodules treatment

The thyroid nodule is one of the most common lesions in clinical practice and has been increasingly detected in approximately 50% of the general population by ultrasound (US) examination in the past two decades due to the widespread use of radiological imaging.

Benign thyroid nodules (BTNs) proven cytologically by fine-needle aspiration biopsy (FNAB) account for 85 to 95% of all thyroid nodules.

Despite the fact that the majority of thyroid nodules diagnosed are benign and do not cause significant clinical symptoms, some nodules may lead to compression-related symptoms. In addition, thyrotoxic symptoms may develop due to hyperfunctioning of some nodules.

To date, surgical resection is the main treatment for thyroid nodules. However, it has serious drawbacks such as leading to excessive surgical trauma or hypothyroidism, influencing the aesthetic aspect of the neck, or increasing a post-operative recurrence rate.

RFA has shown good efficacy and safety in the management of thyroid nodule related cosmetic problems and pressure symptoms.

MWA is a newly developed local thermal ablation technique that has fast heating speed, strong coagulation ability and large ablation zone, and has become a great therapeutic method in heat ablation therapy (8) The advantages of ultrasound-guided minimally invasive ablation therapy over the traditional surgery include simpler operation and shorter treatment time. (8)

Eligibility Criteria:
Inclusion Criteria:

* Solid or mixed nodules with predominant solid component with benign pathological result from US guided fine needle aspiration (FNAC).
* Symptomatic and/or cosmetic problems.
* Clinical thyrotoxicosis and hyperthyroidism caused by autonomously functioning thyroid nodules (AFTNs)
* Refusal or ineligible for surgery.
* Anxiety about a malignant transformation.

Exclusion Criteria:

* Malignant nodules on US.
* Cytological evidence for malignancy
* Patients with abnormal coagulation profile.
* previous surgery or medicine for the thyroid, and vocal cord palsy in the side contralateral to the target nodules.
Glutamine Challenge as Predictor of Hepatic Encephalopathy After Transjugular Intrahepatic Portosystemic Shunt (TIPS)

Transjugular intrahepatic portosystemic shunt (TIPS) is the first-line therapy for patients with cirrhosis and refractory ascites. However, mental changes known as hepatic encephalopathy (HE) frequently occur after TIPS. There is no effective method to predict HE after TIPS. Oral glutamine challenge (OGC) and psychometric tests have been used to assess the risk for HE, but never in patients undergoing TIPS. Severe muscle loss may also predispose patients to HE. The aim of the present study is to assess if both the OGC and psychometric tests can accurately predict the development of overt HE after TIPS. Patients will be studied before TIPS and followed after TIPS for the development of HE. The role of muscle loss in favoring HE, as well as is possible reversibility after TIPS will also be investigated.

In cirrhosis, up to 10% of patients develop refractory ascites. TIPS (transjugular intrahepatic portosystemic shunt) is the first-line therapy for these patients. However, 30% will go on to develop hepatic encephalopathy (HE) as a consequence of TIPS, and there is no effective method to predict this outcome. Oral glutamine challenge (OGC) is used to functionally assess ammonia metabolism, and the severity of porto-systemic collateralization, and it has been used to predict overt HE. Psychometric tests (i.e. Psychometric Hepatic Encephalopathy Score \[PHES\] and inhibitory control test) allow the identification of covert forms of HE and can also predict overt HE. Severe sarcopenia may also predispose patients to HE. The aim of the present study is to assess if both the degree of impairment in ammonia metabolism as estimated with the OGC, and cognitive status as determined by psychometric tests, can accurately predict the development of overt HE after TIPS. Patients will be studied before TIPS and followed after TIPS for the development of overt HE. The role of sarcopenia in favoring HE, as well as is possible reversibility after TIPS will also be investigated.

Eligibility Criteria:
Inclusion Criteria:

* Cirrhosis (any etiology)
* Refractory ascites or hepatic hydrothorax and plan for TIPS placement

Exclusion Criteria:

* Well-documented overt hepatic encephalopathy, either persistent or at the time of screening
* Any contraindication for TIPS placement

  * Except for coagulopathy and thrombocytopenia (decided on an individual basis)
* Uncontrolled depression/anxiety disorder or use of antipsychotic drugs
* Active use of alcohol or illicit drugs
* History of dementia
* TIPS planned for another indication.
* Active alcoholic liver disease.
Device-guided Breathing Exercises on Blood Pressure in Diabetic Patients

Rationale: Hypertension is an important risk factor of cardiovascular disease, especially in patients with type 2 diabetes mellitus (T2DM). A relatively recent development for the treatment of hypertension is the use of breathing exercises. The investigators' previous studies with a breathing device did not show any positive results. However, these studies and other trials investigating the effects of breathing devices had not a double-blind design. Therefore, the investigators want to perform a randomized, double-blind, controlled trial in a population of T2DM patients.

Objective: To determine the effect of a device slowing breathing (Resperate©) on office systolic blood pressure (SBP) in diabetic patients with treated hypertension with moderate BP control.

Study design: A randomized, double-blind, controlled trial.

Study population: Patients with type 2 diabetes mellitus, over 18 years old and a baseline systolic blood pressure between 140-160 mm Hg.

Intervention: One group receives treatment with a breathing device (Resperate©) and the other group receives treatment with a "control" breathing device. The latter device does not try to alter the breathing pattern.

Main study parameters/endpoints: The effect of the breathing device on SBP is the main study parameter. Secondary endpoints include diastolic blood pressure (DBP) and quality of life.


Eligibility Criteria:
Inclusion Criteria:

* known T2DM,
* over 18 years old,
* known hypertension with a systolic BP (SBP) between 130-170 mm Hg at the previous visit to the internal outpatient department and at the last visit to the internist (which is the same day as baseline measurement) and treated with one or more anti-hypertensive drugs, which have not been changed for the preceding three months. At baseline the SBP should be between 140-160 mm Hg, measured by the investigator.

Exclusion Criteria:

* patients with orthostatic hypotension,
* known heart failure (NYHA III-IV) and/or patients with pulmonary disease (for example asthma, chronic obstructive pulmonary disease and pulmonary fibrosis),
* patients with insufficient knowledge of the Dutch language to understand the requirements of the study,
* additional criteria were hospitalization in the past 3 months, deafness, blindness and cognitive abilities deemed insufficient for operation of a study device.