cyrilzakka/clinical-trials huggingface dataset:
Outcomes of Patients With Foraminal Stenosis

The present study was to see the effect of minimally invasive neural foraminotomy for lumbar foraminal stenosis with unilateral radicular pain. Traditionally, fusion was was done for the patients, but recent development enable surgeon to decompress neural foramen without rigid spinal fusion. Although, clinical effect of neural foraminotomy may have limitation in attaining a comparable result to fusion surgery, a cost-effective analysis may reveal a result in a different perspective. In this regard, we designed a prospective cohort study to see the cost-effectiveness of neural foraminotomy compared to fusion surgery.

Control: 1-2 levels fusion surgery Intervention: neural foraminotomy

Inclusion patients between 40 - 100 years. No improvement despite nonsurgical treatment for more than 3 months. No history of lumbar fusion surgery Single or double-level lumbar foraminal stenosis with corresponding leg pain

Exclusion Severe neurological deficit (motor grade less than Grade III) Combined inflammatory joint disease Combined neurodegenerative disease such as Parkinson's disease or dementia Combined cancer, traumatic fracture marked spinal deformity (C7 sagittal vertical axis \> 10cm)

Surgery and follow-up Patients underwent foraminotomy and visits outpatient clinical at determined time points (postoperative month 1, 6, 12 and 24 months) Their clinical outcomes were recorded at each visit. Their medical costs were retrieved at the time of analysis by using hospital records.

Statistical analysis means: T-test

Eligibility Criteria:
Inclusion:

* patients between 40 - 100 years.
* No improvement despite nonsurgical treatment for more than 3 months.
* No history of lumbar fusion surgery.
* Single or double-level lumbar foraminal stenosis with corresponding leg pain

Exclusion:

* Severe neurological deficit (motor grade less than Grade III)
* Combined inflammatory joint disease
* Combined neurodegenerative disease such as Parkinson's disease or dementia \* Combined cancer, traumatic fracture
* Marked spinal deformity (C7 sagittal vertical axis \> 10cm)
Study to Assess the Efficacy and Safety of FK506 Combined With Mycophenolate Mofetil (MMF) in Lupus Nephritis (III/IV/V)

This is an open, prospective study to assess the efficacy and safety of Tacrolimus (FK506) combined with MMF in the treatment of class III, IV, V + IV or V + III lupus nephritis.

1. To assess the efficacy of FK506 combined with MMF vs intravenous CTX pulses in treatment of class Ⅲ, Ⅳ, Ⅴ + Ⅳ or Ⅴ + Ⅲ LN.
2. To investigate the safety and tolerability of FK506 combined with MMF vs intravenous CTX pulses in the treatment of class Ⅲ, Ⅳ, Ⅴ + Ⅳ or Ⅴ + Ⅲ LN.
3. To explore the dosing of FK506 combined with MMF and their effective range of blood concentration.

Eligibility Criteria:
Inclusion Criteria:

1. Female patients with a diagnosis of systemic lupus erythematosus (SLE) according to the criteria of American Rheumatic Association, 1982, aged between 12-50 years, with score of SLE-DAI (Disease Active Index) of more than 12 (not including class V LN).
2. Patients diagnosed according to ISN/RPS 2003 classification criteria: class Ⅲ, Ⅳ, Ⅳ + Ⅴ, Ⅲ + Ⅴ LN by renal biopsy within 3 months, CI\< 4，Scr\< 3 mg/dl.
3. Patients with a proteinuria ≥ 1.5 g/24h, or active urine sediment.
4. Patients who signed written informed consent forms (patients less than 18 years old with their parents/legal representative' signatures), and have given their consent to follow all study procedures and follow-ups.

Exclusion Criteria:

1. Patients who have received treatment of cytotoxic drugs such as cyclophosphamide (CTX), cyclosporine A for more than 1 week within three months.
2. Patients with serum creatinine ≥ 3 mg/dl（265 μmol/L).
3. Patients with severe infection or central nervous system symptoms.
4. Patients who have impaired liver function, with ALT/GPT or AST/GOT twice more than the normal upper limit or who have active hepatitis.
5. Patients who have abnormal blood glucose, with a fasting blood glucose \> 6.2 mmol/L or post meal blood glucose \> 11.2 mmol/L.
6. Patients who are pregnant or lactating.
7. Patients who are known to be allergic to a macrolide.
Effects of a 12-week Respiratory Muscles Training Program in Persons With Relapsing- Remitting Multiple Sclerosis

Multiple sclerosis (MS) is the most common inflammatory demyelinating chronic disease of the central nervous system and the second leading cause of disability in young adults. Motor deficits also involve respiratory muscles. This involvement is present from early stages of disease and is frequently dismissed by professionals until advanced stages of disease. The effect of a training program of respiratory muscles is not sufficiently studied. The aim of this research is to assess the clinical and functional response of a 12-week respiratory muscles training program (RMTP) for persons with relapsing-remitting multiple sclerosis (RRMS).

This study is consisted with two sub research:

Firstly, a single-blind randomized clinical trial will be carried out in 40 persons with RRMS. Participants either will be received (n = 20) peripheric resistive muscle training program which will be supplemented by a 12-week Respiratory Muscles Training Program (RMTP) with ORYGEN Dual® device for 50 minutes, twice a week during three months or (n = 20) they will be received peripheric resistive muscle training program and health education program. Main outcomes will be strength of the respiratory muscles assessed by maximal inspiratory and expiratory pressure measurements (MIP and MEP). The secondary outcomes will be assessed the quality of life (MSQOL-54), walking speed (T25-FW, MSWS-12 and Hauser ambulatory index), fatigue (MFIS), endurance of the respiratory muscles (10RM) manoeuvre and peripherical muscle strength (Multiple-Sit-to-Stand Test and handgrip strength).

Secondly, the qualitative research where researchers will interview participants about their interest in carrying out the intervention (difficulties and advantages) and identify themes of interest about changes in quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Males and females older 18 years of age with diagnosis relapsing-remitting multiple sclerosis according to revised McDonald Criteria 2005.
* Have mild or moderate impairment of gait according to Hauser ambulatory index. The score 1 and 5 will be included (both values inclusive).
* Subjects who have read, understood, signed and dated the informed consent form.

Exclusion Criteria:

* Disability caused by other diseases
* Clinically relevant cognitive or linguistic disorders which are unable to fill in the questionnaires by him/herself
* Subjects used medication with corticosteroids within the last month (or 30 days) prior to study day 1.
* Have a recent outbreak (last month) not stabilized prior to inclusion in the study
Otteroo Case Series

Rationale. The Otteroo is a floatie which supports an infant or young child with their head above and their body in water. Researchers are proposing that the Otteroo may be a good "tool" to facilitate exploring the ability to move and control one's body before locomotion develops. Intervention. Otteroo will be used as an adjunct to standard care for 4 weeks.

Objectives or purpose. The purpose of this project is to measure overall developmental status before, during, and after Otteroo experience. Study population or sample characteristics. Participants will be 4 pre-locomotor infants or young children for whom a healthcare provider or caregiver has identified concerns about potential developmental delay. Study methodology. A single-subject research design will be used: measures of infant development will be collected across a 4-week baseline period (standard care), 4 weeks of intervention (standard care and Otteroo use), and a 4 weeks of reversal/retention period (standard care). Study endpoints or outcomes. The end of the study is the final assessment at 12 weeks. Follow-up. None. Statistics and plans for analysis. Researchers will calculate descriptive statistics (mean, range, coefficient of variation) for all measures and describe changes over time, relating the participant's performance at each time point to norm-referenced results for their age.

Eligibility Criteria:
Inclusion Criteria:

* pre-locomotor (able to locomote independently less than 4 feet)
* a healthcare provider or caregiver has identified concerns about potential developmental delay

Exclusion Criteria:

* younger than 8 weeks of age
* older than 66 months of age
* body weight of more than 35 lbs
* diagnosis of Down syndrome
* clinical presentation of ligamentous laxity
* without access to an appropriate water source (bathtub or pool depending on the size of the child)
* with prior experience using Otteroo
Ketoconazole, Dexamethasone, and Hydrocortisone in Treating Patients With Prostate Cancer That Did Not Respond to Androgen-Deprivation Therapy

RATIONALE: Studying samples of blood in the laboratory from patients with cancer receiving ketoconazole together with dexamethasone and hydrocortisone may help doctors learn more about how these drugs are used by the body.

PURPOSE: This randomized clinical trial is studying how ketoconazole, dexamethasone, and hydrocortisone act in the body of patients with prostate cancer that did not respond to androgen-deprivation therapy.

OBJECTIVES:

* To evaluate the pharmacokinetics of oral dexamethasone with and without oral ketoconazole in patients with androgen-independent prostate cancer.
* To compare the pharmacokinetics of oral hydrocortisone with and without oral ketoconazole in these patients.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive oral dexamethasone twice daily on days 1-14, oral ketoconazole 3 times daily on days 2-14 and 30-42, and oral hydrocortisone twice daily on days 29-42.
* Arm II: Patients receive oral hydrocortisone twice daily on days 1-14, oral ketoconazole 3 times daily on days 2-14 and 30-42, and oral dexamethasone twice daily on days 29-42.

In both arms, patients may receive ketoconazole and hydrocortisone as standard salvage therapy off study.

In both arms, patients undergo blood sample collection on days 1, 14, 29, and 42 for pharmacokinetic studies.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Confirmed diagnosis of prostate cancer
* Must have failed standard androgen-deprivation therapy

  * Evidence of rising PSA

PATIENT CHARACTERISTICS:

* ECOG performance status 0-2
* Creatinine ≤ 2.0 mg/dL
* AST and ALT \< 4 times upper limit of normal
* Bilirubin \< 2.0 mg/dL
* No active congestive heart failure
* No allergy to ketoconazole, dexamethasone, hydrocortisone, or to one of the components of dexamethasone, hydrocortisone, or ketoconazole
* No active infection
* No uncontrolled glaucoma
* No active peptic ulcer disease
* No uncontrolled diabetes mellitus
* Fertile patients must use effective contraception during and for 3 months after completion of study therapy

PRIOR CONCURRENT THERAPY:

* More than 2 weeks since prior and no concurrent drugs known to interact with study treatment
Effects of Arzoxifene on Bone Fractures and Incidence of Breast Cancer

The purpose of this trial is to study:

* Effects of arzoxifene on bone fractures and bone mass.
* Effects of arzoxifene on getting breast cancer.
* Effects of arzoxifene on certain types of cardiovascular events, such as heart attack and stroke.
* Effects of arzoxifene that changes the amount of certain substances in the blood that are related to osteoporosis and cardiovascular health.
* Effects of arzoxifene on the uterus.
* The safety of arzoxifene and any side effects.


Eligibility Criteria:
Inclusion Criteria:

* 60-85 years of age
* Female
* At least two years since last menstrual cycle

Exclusion Criteria:

* Abnormal or unexplained vaginal bleeding.
* Bone disorders, other than osteoporosis or low bone mass
* History of breast cancer, cancer of the uterus, or any cancer in the last five years (except skin cancer).
* History of cerebral vascular accidents or venous thromboembolic events
* Medications outlined
Ex-vivo Effect of New Oral Anticoagulants on Point-of-care Devices

Concentration determinations of anticoagulants require plasma instead of whole blood, and results are not immediately available to clinicians. Monitoring anticoagulants concentration along with bedside methods may provide an alternative guide for administration of the NOAC.

The purpose of this investigation is to compare bedside coagulation assays in whole blood with plasma concentrations of the new oral anticoagulants (NOAC) in patients treated with therapeutic dosis of NOAC.

This open-label study will be performed by ex vivo investigations. Patients receiving the NOAC as dabigatran or rivaroxaban in therapeutic doses are recruited and informed consent of two blood sampling times will be obtained in correlation to the time of drug intake (two and 24 hours after drug intake). The bedside measurements will be performed and compared directly with the concentrations determined by plasma concentration assays. These investigations will be performed at the department of Angiology at the university hospital Frankfurt.

Eligibility Criteria:
The indication for the use of NOAC is provided by the attending physician. The criteria for inclusion and exclusion criteria for the use of the new oral anticoagulants must meet appropriate eligibility criteria and the clinical guidelines that are described in the SOPs.

Patients treated with dabigatran 2x150mg / d for the prevention of stroke and systemic embolism in non-valvular atrial fibrillation are included.

Moreover, patients treated with rivaroxaban 20 mg / d for DVT prophylaxis and treatment of recurrent DVT or PE are included.
Parent Specific Depression Education and Motivation

This project is an investigator-initiated, randomized-controlled trial of the effectiveness of written and verbal parent-specific depression education and motivational advice in increasing participants self-disclosed intention to seek follow-up care for possible depression symptoms. The control condition is written and verbal general depression education and advice. Hypothesis: the office-based experimental intervention of written and verbal parent-specific depression and emotional health education and motivational advice increases intention to seek follow-up services for emotional health or depression, when compared to written and verbal general depression education and advice.

Maternal depression is a common problem, debilitating for mothers and affecting parenting practices with negative effects on the behavior, development, and physical health of children. The value of identifying and treating maternal depression for child development and well-being is well documented. Unfortunately, there are multiple barriers to the recognition and treatment of maternal depression. This is particularly problematic in younger women, as they are less often seen for health care. The overall objective of this project is to test whether the uptake of follow-up recommendations for potential depression by mothers identified by screening in clinical settings is improved by parent-specific targetting of depression education and motivational advice.

Eligibility Criteria:
Inclusion Criteria:

* Parent of a child between the ages of 2 days and 12 years who is a patient of the UC Davis Pediatric Clinic.
* Primary, female caregiver
* Feeling down, depressed, or hopeless or little interest or pleasure in doing things.
* Not currently receiving care from a mental health practitioner.
* Comfortable speaking English without an interpreter.

Exclusion Criteria:

* Parent of a child younger than 2 days or older than 12 years.
* Dad, Foster parent, or other short term guardian.
* Currently in treatment with a mental health practitioner.
* Limited English Proficiency
Manipulation Effects on Abdominal Muscles

The purpose of this study is to understand how different physical therapy interventions affect the use of certain abdominal muscles in patients with low back pain.

Patients with low back pain will undergo ultrasound imaging of the lateral abdominal wall to measure resting and contracted thickness of the transversus abdominis muscle. Following the pre-intervention measurement, patients will receive one of two physical therapy interventions (side lying thrust joint manipulation or side lying non-thrust oscillations into slight rotation) which will have been randomly assigned. Immediately after intervention, ultrasound imaging will be repeated on the resting and contracted thickness of the transversus abdominis.

Eligibility Criteria:
Inclusion Criteria:

* Currently receiving physical therapy treatment for back pain or back pain symptoms
* 18-70 years of age
* Able to perform the abdominal drawing in maneuver

Exclusion Criteria:

* Presence of a serious pathology
* Diagnosis of spinal stenosis or symptoms in both lower legs (changes in sensation, muscle weakness)
* Any history of low back surgery, rheumatoid arthritis, osteoporosis, osteopenia, or ankylosing spondylitis
Effectiveness of Multigrain Supplementation Among the Rheumatoid Arthritis Patients

The objective of this study is to evaluate the effect of high fiber multigrain supplementation on the level of clinical disease severity measures, blood inflammatory molecules, and nutritional status changes in RA patients.

Rheumatoid Arthritis (RA) is a chronic inflammatory, autoimmune rheumatic disease, resulting in progressive joint inflammation and destruction. At present, there is no known cure for this disease. As a consequence of the potential side effects, many RA patients turn to other alternative remedies such as specialised diets and/or dietary supplements in a bid to relieve their symptoms. Therefore, the current study aims to examine the effectiveness of high fiber multigrain supplementation on the level of clinical disease severity measures, blood inflammatory molecules, together with the nutritional status changes in RA patients, as compare with conventional drug treatments.

Eligibility Criteria:
Inclusion Criteria:

* RA patients according to the American College of Rheumatology (ACR)
* Moderate (DAS 28 = 3.2 - 5.1) and severe (DAS 28 \> 5.1) RA manifestation
* Chronological age: 21 years and above
* Stable RA patients who are receiving NSAIDs, glucocorticoids/DMARDs (for example leflunomide, methotrexate, sulfasalazine and hydroxychloroquine) for at least 3 months prior to entering the study
* Not taking antioxidant/antiinflammatory supplements (Example of antioxidant: vitamin C, vitamin E, grape seed extract, garlic capsule, ginkgo biloba) (Example of anti-inflammatory supplement: fish oil, curcumin extract, ginger extract, spirulina)

Exclusion Criteria:

* Having liver (chronic liver failure, cirrhosis, all types of hepatitis), kidney (chronic kidney disease, haemodialysis) or haematological (anaemia, thalassemia, haemophilia) disorders
* Active gastric/duodenal ulcer
* Psychiatric disease/mental retardation (bipolar disorder, depression, schizophrenia)
* Cancer (all types), Diabetes Mellitus (Type I and II), uncontrolled hypertension (BP at 140/90 mmHg for the past 3 months), and endocrine disorders (Cushing's disease, gigantism and hyperthyroidism).
* Alcohol and drug abuse (self-mentioned or as recorded in the medical card)
* Other autoimmune/inflammatory diseases (systemic lupus erythematosus, multiple sclerosis, gout, psoriasis, chronic inflammatory demyelinating polyneuropathy)
* Pregnancy/lactation
* Hormone replacement therapy (for at least 3 months prior to entering the study)
* Herbal remedies (any parts from the plants such as flowers, rhizome, seeds, roots, leaves, fruits, stems)
* Vegetarian patient (pure vegan)
* Gluten intolerance
* Participations from another supplementary program
Clinical Trial to Compare The Pharmacokinetics of A Pregabalin Controlled Release Tablet 300mg and Immediate Release Formulation

The purpose of this study is to compare the pharmacokinetics profiles of pregabalin sustained release tablet (300mg) to immediate release capsule(150mg \* 2) while multiple dosing.


Eligibility Criteria:
Inclusion Criteria:

* 19\~44 aged healthy adult.
* someone tho has at least 50kg body weight and ideal body weight ±20%

Exclusion Criteria:

* someone has acute symptom at screening phase
* someone has any disease or symptoms which is clinically significant
* someone had been determined during healthy examination in screening period
* AST or ALT \> 1.25 times than normal
* Total bilirubin \> 1.5 times than normal
* someone who has a history of allergy, anaphylaxis, drug abuse or misuse.
* someone who had enrolled to other clinical trial within the last 60 days.
* someone who had donated blood within the last 60 days.
* someone who can't take a meal derived from this trial.
* someone who has taken abnormal meals like which can affect to drug ADME
* someone who has taken other ETC drugs or oriental drugs within the last 14 days, Or OTC drugs within the last 7 days
* someone who has taken caffein continuously (coffee or green tea more than 5 cups per a day) or took caffein since 24hours before.
* someone who has taken alcohol more than 30g/day or smoked more than 10 piece of tobacco/day.
* someone who has galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
Multiple Ascending Doses Study of CG400549

The purpose of this study is to investigate the safety and tolerability of 3 multiple and escalating dose regimens of CG400549 administered orally in healthy volunteers.

This is a Phase 1, 3 cohorts study consisting of a randomised, double-blind, and placebo-controlled design.

Eligibility Criteria:
Inclusion Criteria:

* Age:18-55 years, inclusive
* Body Mass Index :19-30 kg/m2, inclusive
* Sex:male
* Other criteria:healthy; non-smoking or smoking ≤ 10 cigarettes/day

Exclusion Criteria:

* Evidence of clinically relevant pathology
* History of bacterial or viral infection requiring treatment with antibiotics or antivirals within 1 month of study
* Presence or history of esophageal or gastroduodenal ulceration within 1 month before screening.
Adipose-tissue Derived Stem Cells in Flaps Versus Liposuction

The aim of the study is to evaluate a physiological concentration of adipose tissue-derived stem cells (ASC) in excised fat versus fat harvested by liposuction. Participants will act as their own control as both extraction methods are performed on each participant.

Adipose tissue-derived stem cells are of great interest due to their relevance in regenerative medicine and tissue engineering. A reason, being their capacity for multipotent differentiation, tissue repair and immune modulation.

To evaluate a physiological concentration level of ASCs in human fat we investigate two extraction methods of fat, excision and liposuction. This is done through a standardised setup with patients acting their own control. The study is carried out in accordance with the guidelines provided by the International Federation for Adipose Therapeutics and Science and International Society for Cellular Therapy.

Eligibility Criteria:
Inclusion Criteria:

* Eligible women - over the age of 18
* Deemed suitable for abdominoplasty with abdomen pendens, fleur de lis, panniculectomy or belt lipectomy.
* Able to read and understand Danish

Exclusion Criteria:

* Current smokers - patients not having paused for a minimum of four weeks prior to surgery.
* Prior or current adjuvant chemo therapy