cyrilzakka/clinical-trials huggingface dataset:
Impact of the Erigo Machine on Functional Recovery in ICU Patients

This study will assess the effects of the Erigo applied as part of the early mobilization program in the Trauma ICU at the University of Kentucky. It is our hypothesis, that with the Erigo, critically ill patients will tolerate verticalization and mobilization earlier and safely resulting in improved outcomes measured by increased mobility and strength on ICU discharge, decreased requirements for mechanical ventilation, reduced complication rates and decreased ICU and hospital LOS.

The "Erigo" by Hocoma is a combination of tilt table with a robotic stepper device allowing for cyclic leg loading. Erigo now also includes Functional Electrical Stimulation to optimize active neuromuscular stimulation. It allows for protected gradual verticalization and mobilization based on patient tolerance and progress. It has been shown to improve orthostatic tolerance, cerebral blood flow and muscle strength.

Prospective Randomized Controlled Trial will compare two groups. The patients that meet inclusion criteria will be randomized into either the treatment group or a control group. General ICU mobility guidelines consist of scaled activity related to the patients' stability. The control group will get the general ICU mobility treatments and the treatment group will have one mobility treatment replaced with the Erigo treatment.

Eligibility Criteria:
Inclusion Criteria: Admission to Trauma ICU

1. Trauma Patients requiring physical therapy (including severe traumatic brain injury or polytrauma without extremity fractures or unstable thoracic or lumbar spine fracture
2. Burn patients requiring physical therapy
3. GI surgery patients requiring physical therapy
4. Necrotizing fasciitis patient requiring physical therapy

Exclusion Criteria:

Patients with the following conditions:

1. Non-weight bearing on lower extremities
2. Untreated DVT
3. Active hemorrhage
4. Leg length \>102cm or \<72cm
5. Weight \>135kg
6. Systolic BP \> 20mmHg sustained for 10min
7. Heart rate \>20bpm outside goal for more than 20min
8. Intracranial pressure (ICP) \>20mmHg sustained for 10min if applicable,
9. Temperature \>38.2C
Study of STA-1 as an Add-on Treatment to Donepezil

The objective of this study is to evaluate the efficacy and safety of STA-1 vs placebo as an add-on treatment to donepezil in patients with mild to moderate Alzheimer's Disease (AD).


Eligibility Criteria:
Inclusion Criteria:

* Male or female patient aged ≥ 50 years;
* Probable Alzheimer's disease diagnosed by the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria;
* MMSE score between 10-26, inclusive;
* Patient has been treated with donepezil 10 mg per day for at least 3 months prior to screening;
* Patient able to participate in all study evaluations and ingest oral medication as indicated;
* Patient has a responsible caregiver who will accompany the patient to all clinic visits during the study;
* Patient and the responsible caregiver have provided written informed consent before undergoing any study procedures.

Exclusion Criteria:

* Brain image (computed tomography (CT) scan or Magnetic Resonance Imaging (MRI) done within past 12 months prior to the study) and laboratory tests to exclude secondary dementia or non-Alzheimer's dementia;
* Patient with significant clinically central nervous system illness other than AD (e.g. Parkinson's disease, Human Immunodeficiency Virus (HIV) induced dementia, Hachinski Ischaemic Score (HIS) \>4) or dementia complicated by other organic disease or delirium;
* Patient with a severe or uncontrolled Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) Axis I disorder other than Alzheimer's disease, including amnestic disorders, schizophrenia or schizoaffective disorder, bipolar disorder, current major depressive episode, psychosis, panic, or post-traumatic stress disorder;
* Patient suffering from cerebral disturbances following a stroke or a cerebral trauma (if the event occurred within the last 6 months);
* Patient with a history of hypersensitivity to study drugs;
* Patient who has a history or evidence of a medical condition that would expose them to an undue risk of a significant adverse event or interfere with assessments of safety or efficacy during the course of the trial, including but not limited to hepatic, renal, respiratory, cardiovascular, endocrine (e.g., Addison's Disease), immune, neurologic, or hematologic disease as determined by the clinical judgment of the investigator;
* Participation in any research study within the last 30 days;
* Patient with significant alcohol or drug abuse as judged by the investigator.
Post-marketing Re-evaluation of WangBi Granules for Rheumatoid Arthritis

The group used a randomized controlled trial to conduct a post-marketing re-evaluation study of Wangbi granules. The study was conducted to observe the degree of clinical remission in rheumatoid arthritis patients with low disease activity after standard methotrexate and tofacitinib citrate treatment, using a combination of Chinese and Western medicine treatment with Wangbi granules. The study aims to provide evidence-based medical evidence to improve the clinical efficacy of rheumatoid arthritis, enhance the depth of remission, and improve the diagnosis and treatment of rheumatoid arthritis.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18-75 years.
2. Meeting the 1987 ACR or 2010 ACR/EULAR diagnostic criteria.
3. Meeting the diagnostic criteria of Chinese medicine for Kidney deficiency and dampness and stasis blocking channels in Chinese medicine.
4. Rheumatoid arthritis disease activity score DAS28 of 2.6 to 3.2.
5. Regularly taking methotrexate 7.5-15 mg qw and tofacitab 5 mg bid before enrollment and stable treatment regimen for more than 4 weeks.
6. Voluntary participation and signed written informed consent.

Exclusion Criteria:

1. Patients taking immunosuppressive drugs other than traditional DMARDs for rheumatoid arthritis within 3 months prior to enrollment (traditional DMARDs include hydroxychloroquine sulfate, methotrexate, salazosulfapyridine tablets, and raglan polysaccharide tablets, among others).
2. Organ transplant recipients, patients with malignant tumors, patients with heart, brain, liver (ALT/AST \> 3 times the normal upper limit), kidney (Ccr \<60ml/min) and other important organ function impairment or hematological system diseases.
3. Psychiatric disorders such as cognitive disorders, depression, anxiety disorders, somatic dysfunction, cerebral infarction, cerebral hemorrhage, epilepsy, TIA, myelitis, demyelinating lesions and other central neurological disorders, or peripheral neurological disorders such as restless legs syndrome. peripheral neurological disorders such as restless legs syndrome.
4. Women and men who are pregnant or breastfeeding or who are planning a pregnancy within the next 6 months; during the trial or within 1 month of the last dose Women of childbearing age who are unable or unwilling to use adequate contraception, or whose spouse is unwilling to use contraception, within one month of the last dose or within one month of the last dose are unwilling to use contraception.
5. Persons with a BMI greater than 35 (kg/m2), allergic to the test drug, or participating in other clinical trials.
6. Other conditions deemed by the investigator to be inappropriate for trial participation (out-of-town patients unable to be followed up, etc.).
Assessment of Safety and Performances of HYPE Stems Associated to a SERF Acetabular Cup in Hip Arthroplasty (2017-01-NH)

The use of cementless femoral stems is known to provide satisfactory long-term clinical results. Extensive and durable osseointegration of these implants has been reported in numerous series, despite the use of stems with different geometry and coating distribution.

This study will validate the performance and safety of the HYPE (SERF) stems in the context of the 93/42/EEC directive and in relation to the recommendations of the MEDDEV 2.7.1 (Guideline for post-marketing follow-up), which provides for a systematic procedure for monitoring clinical data in order to verify the performance claimed for medical devices.


Eligibility Criteria:
Inclusion Criteria:

* Male or female
* Degenerative or inflammatory hip disease requiring total hip replacement
* Primary or secondary osteoarthritis,
* Advanced joint destruction resulting from rheumatoid arthritis or traumatic origin,
* Avascular fracture or necrosis,
* Displaced subcapital and transcervical fracture as well as PAPROSKY stages I to IIB bone defects.
* Joint destruction of traumatic origin
* Following a previous operation, provided that the new device does not interfere with the material in place (osteosynthesis, joint reconstruction, arthrodesis, hemiarthroplasty, total arthroplasty).

Exclusion Criteria:

* Patient with a psychological, family, sociological or geographical situation likely to hinder compliance with the study protocol and follow-up
* Known pregnancy in progress
* Breastfeeding
* Patient requiring a bone graft
* Neurological disorders or other pathology that may influence locomotion
* History of sepsis in the hip to be operated on
* Short-term vital prognosis
The Reach and Effectiveness of Technology-enhanced Diabetes Prevention Programs

The aim of this project is to evaluate the reach, effectiveness, and costs of two patient-centered, theory-based, technology-enhanced diabetes prevention programs to initiate and sustain weight loss among pre-diabetic adults (i.e. impaired fasting glucose or impaired glucose tolerance) within a health care setting. The overall aim is consistent with the NIDDK's Behavioral/Prevention Research Program's focus on individual, family, and community-based strategies for prevention of diabetes and its complications. While evidence of lifestyle interventions that increase physical activity and improve eating habits to achieve modest weight loss in delaying and preventing the onset of type 2 diabetes continues to mount, the translation of these interventions into effective programs to health care settings with modest resources remains a challenge. The proposed research project will conduct a pragmatic clinical trial that employs a hybrid Preference/Randomized Controlled Trial (RCT) designed to compare two technology-enhanced diabetes prevention programs in achieving objectively verified weight loss relative to a standard care control at comparatively lower costs. Adult patients (18 years of age and older) at risk for developing diabetes will be randomized to either the Choice group or the Randomization group. Those patients randomized to the Choice group (n=240) will have the opportunity to choose one of two programs to participate in: 1. A 2-hour Small-Group (SG) session, with automated interactive voice response (IVR) systems targeting personal action planning to support lifestyle change and weight loss over a period of 12 months; or 2. A DVD-based intervention with the same IVR follow-up. Those patients assigned to the RCT group (n=360) will be randomized to one of three groups: 1. SG/IVR; 2. DVD/IVR; or 3. Enhanced standard-care (SC). SC includes the referral to a currently offered pre-diabetes class. Primary outcome measures include weight loss, cost, and reach of each program. Secondary outcome measures include physical activity behavior; eating behavior; and process evaluation. It is hypothesized that both the SG/IVR and the DVD/IVR interventions will produce significantly greater amounts of weight loss at 6, 12, and 18 months following program initiation than SC but will not differ from one another. The investigators also hypothesize that the DVD/IVR will have broader reach and may be more cost-effective than SG/IVR or SC.


Eligibility Criteria:
Inclusion Criteria:

* age = or \> 18 years
* BMI = or \> 25

Exclusion Criteria:

* Patient's medical record contains ICD-9 codes for a diagnosis of any type of diabetes, congestive heart failure or coronary artery disease
* Pregnant or becomes pregnant during trial
* Contraindication to physical activity or weight loss
* No access to phone
* Does not speak or read English
* Patient has indicated "Do Not Contact" in Carilion patient record
Bioavailability of BI 1356 After Single Oral Administration Given as Different Tablet Formulation in Healthy Male Volunteers

Study to investigate the relative bioavailability of 5 mg BI 1356 as tablet formulations (Trial formulation) TF II and Intended final formulation (iFF) vs. 5 mg BI 1356 as tablet TF IIb


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs, Blood Pressure (BP), Pulse Rate (PR), 12-lead Electrocardiogram (ECG), clinical laboratory tests

  * No findings deviating from normal and of clinical relevance
  * No evidence of a clinically relevant concomitant disease
* Age ≥21 and Age ≤55 years
* BMI ≥18.5 and BMI ≤29.9 kg/m2 (Body Mass Index)
* Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation

Exclusion Criteria:

* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Surgery of gastrointestinal tract (except appendectomy)
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
* History of relevant orthostatic hypotension, fainting spells or blackouts
* Chronic or relevant acute infections
* History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
* Intake of drugs with a long half-life (\> 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
* Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
* Participation in another trial with an investigational drug within two months prior to administration or during the trial
* Smoker (\> 10 cigarettes or \> 3 cigars or \> 3 pipes/day)
* Inability to refrain from smoking on trial days
* Alcohol abuse (more than 60 g/day)
* Drug abuse
* Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
* Excessive physical activities (within one week prior to administration or during the trial)
* Any laboratory value outside the reference range that is of clinical relevance
* Inability to comply with dietary regimen of study centre
Efficacy of 8-week Supervision in Home Based Pulmonary Rehabilitation

In korea, it is not easy to practice standard pulmonary rehabilitation (PR). in this study, we'll educate PR to patients and make reservation for re-visiting outpatients clinics with PR diary. we want to confirm whether patients, who perform home based PR during more than 30 minutes in 3 days per week, present improved dyspnea score or quality of life compared with non-compliance group.


Eligibility Criteria:
Inclusion Criteria:

* forced expiratory volume-one second / forced vital capacity \< 0.7 in post-bronchodilator pulmonary function test
* adults 40 years or older
* no history of acute exacerbation within 4 weeks
* no history of education for pulmonary rehabilitation within 6 months
* no change of medication for chronic obstructive pulmonary disease within 4 weeks
* dyspnea more than Modified Medical Research Council grade 0

Exclusion Criteria:

* adults under 40 years old
* no consent
* history of acute exacerbation within 4 weeks
* history of education for pulmonary rehabilitation within 6 months
* change of medication for chronic obstructive pulmonary disease within 4 weeks
* dyspnea only Modified Medical Research Council grade 0
* comorbidity, including cardiovascular disease, orthopedic disease, neurologic disease, optic disease, uncontrolled hypertension
* enrolled other clinical trial
* on long term oxygen therapy
One-shot Ovarian Stimulation Protocol (One-shot)

The current prospective observational pilot study aims to evaluate the endocrine profile of a single-injection protocol (single CFA + daily oral administration of CC).


Eligibility Criteria:
Inclusion Criteria:

Age \<= 40

AMH (Anti-Mullerian Hormone) 1.2-3.5 ng/ml or AFC 7-20

No family history of hereditary or chromosomal diseases

Body mass index (BMI) 18 to 30 kg/m2
A Study of Olaratumab and Doxorubicin in Participants With Advanced Soft Tissue Sarcoma

The purpose of this study is to assess how the body handles olaratumab when it is given with another drug called doxorubicin.

The safety and tolerability of these drugs will be studied. Each participant will complete two 21-day cycles in a fixed order. Participants who complete Cycle 2 may continue to receive olaratumab + doxorubicin for an additional six 21-day cycles and then may receive olaratumab alone until discontinuation criteria are met.

Screening is required within 21 days prior to first dose.

Part B was added in October, 2015 to assess how the body handles a higher dose of olaratumab when given with doxorubicin.

Participants may only enroll in one part.


Eligibility Criteria:
Inclusion Criteria:

* Have histological or cytological evidence of a diagnosis of soft tissue sarcoma (STS) that is advanced and/or metastatic
* Have the presence of measurable and/or nonmeasurable disease
* Have given written informed consent prior to any study-specific procedures
* Have a performance status of less than or equal to 2 on the Eastern Cooperative Oncology Group (ECOG) scale
* Have discontinued previous treatments for cancer and recovered from the acute effects of therapy
* Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures

Exclusion Criteria:

* Have received treatment within 28 days of the initial dose of study drug with an investigational product or non-approved use of a drug or device for noncancer indications
* Have received prior treatment with doxorubicin, daunorubicin, idarubicin, and/or other anthracyclines and anthracenediones
* Have active central nervous system (CNS) metastasis. Participants with treated CNS metastases are eligible for this study if they are not currently receiving corticosteroids
* Have unstable hepatic disease with a grade equal to or greater than Child-Pugh B
* Have an active fungal, bacterial, and/or known viral infection including human immunodeficiency virus (HIV) or viral (A, B, or C) hepatitis
* Have a history of another primary cancer, with the exception of a) curatively resected nonmelanoma skin cancer; b) curatively treated cervical carcinoma in situ; or c) other primary solid tumor treated with curative intent, no known active disease present, and no treatment administered during the last 3 years prior to study entry
* Have a history of chronic heart failure or left ventricular dysfunction
* Have a resting heart rate of less than (\<)50 beats per minute (bpm) or greater than (\>)100 bpm
* Have a history of radiation therapy involving the mediastinal/pericardial area. Previous radiation therapy is allowed but must not have included whole pelvis radiation
Pilot Biomarker Trial to Evaluate the Efficacy of Itraconazole in Patients w/ Basal Cell Carcinomas

Basal cell carcinomas (BCCs) are the most common human cancer in the US and affect over 1 million people. There is no effective drug to prevent basal cell carcinomas of the skin.

We hope to learn if an oral anti-fungal drug, itraconazole, might inhibit a marker of proliferation and a biomarker (tumor signaling pathway) of BCC development.

Itraconazole is an FDA-approved drug for the treatment of fungal infections of the skin, and has been used for the past 25 years with relatively few side effects. It has been shown in mice to reduce a BCC biomarker and to reduce growth of BCCs.

Thus, it may reduce BCC growth in humans.

Participants with at least one BCC tumor measuring 4 mm or greater in diameter will be enrolled onto 1 of 2 treatment cohorts to receive oral itraconazole.

* Cohort A - 400 mg itraconazole (as 200 mg twice daily for 30 days), stratified by:

  * Cohort A1 - Participants are vismodegib-naive.
  * Cohort A2 - Participants had received prior vismodegib treatment.
* Cohort B - 200 mg itraconazole (as 100 mg twice daily, for up to 4 months). The objective of this cohort is to assess the anti-cancer efficacy of lower-dose extended treatment.
* Control Group - Tumors from untreated participants.

Eligibility Criteria:
INCLUSION CRITERIA

* At least one BCC tumor (greater than 4 mm in diameter) at any skin location, to be biopsied and surgically removed.
* Had at least one liver function test \[eg, aspartate aminotransferase (AST), alanine aminotransferase (ALT)\] with normal results in the last year.
* Consent to research use of their BCC tissue.
* Cohort A or B: Willing to take itraconazole during the 2 to 3 weeks between biopsy and surgical removal of BCC

EXCLUSION CRITERIA

* History or current hepatitis or other liver disease.
* Currently taking systemic medications that would affect BCC tumors (oral retinoids) or metabolism of itraconazole (anti-convulsants, corticosteroids)
* History or current evidence of malabsorption or liver disease within the one year prior to enrollment.
* History or current evidence of hyperthyroidism increasing metabolism of itraconazole
* Unable to attend to 2nd study visit at Stanford for Mohs surgical excision
* Current immunosuppression disease (cancer, autoimmune disease)
* Receiving immunosuppressive drugs
* Pregnant
* Lactating
* Any female actively trying to become pregnant
Determine the Effects of C-administration of AZD7325 and an Oral Contraceptive in Healthy Female Subjects

The purpose of this study is to evaluate the effect of repeated doses of AZD7325 on the pharmacokinetics of ORTHO-CYCLEN, a monophasic oral contraceptive


Eligibility Criteria:
Inclusion Criteria:

* If previously pregnant, must be \> 6 month post-partum at the time of randomization
* Body Mass Index (BMI) greater than or equal to 18 and less than or equal to 30 kg/m2

Exclusion Criteria:

* Use of any prescription medication within 14 days of screening
* current smoker or history of smoking within the last 3 months prior to enrollment
* Abnormal pap smear exam result within one year of enrollment.