cyrilzakka/clinical-trials huggingface dataset:
An Evaluation of Non-invasive ICP Monitoring in Patients Undergoing Invasive ICP Monitoring Via an External Ventricular Drainage (EVD) Device

Invasive intracranial pressure (ICP) monitoring is highly effective, but involves risks. HS-1000 measures ICP non-invasively by assessing the acoustic properties of the patient's head. HS-1000 device, a proprietary new non-invasive ICP monitor, is expected to safely and accurately monitor ICP with minimal discomfort to patients, and provide information about normal or elevated ICP levels to the physicians.

The study objective is to compare the accuracy and safety profile of HS-1000, a non-invasive ICP monitor, to invasive ICP monitoring via an external ventricular drain (EVD)

HS-1000 device, a proprietary new non-invasive ICP monitor, is expected to safely and accurately monitor ICP with minimal discomfort to patients, and provide information about normal or elevated ICP levels to the physicians

Eligibility Criteria:
Inclusion Criteria:

* Adult men and women subjects, aged 18 years old and over at screening visit
* Patients undergoing invasive ICP monitoring via an external ventricular drainage (EVD) device for clinical management
* Survival expectancy greater than one week
* Subject or legal authorized representative (per local regulation) is able and willing to comply with the requirements of the protocol
* Subject or legal authorized representative (per local regulation) is able to understand and sign written informed consent to participate in the study

Exclusion Criteria:

* Subject with ear disease, ear trauma
* Subjects with a bony abnormality (skull defect)
* Subjects with severe head trauma in which the location and/or severity of the skull fracture(s), i.e. frank skull fracture or major joint dislocations may jeopardize HeadSense monitoring procedure
* Subjects with cerebral fluid (CSF) leakage from the ear (CSF Otorrhea)
* Known allergy or hypersensitivity to any of the test materials or contraindication to test materials
* For women of childbearing potential: pregnancy (positive pregnancy test) or breast-feeding
* Subjects currently enrolled in or less than 30 days post-participation in other investigational device or drug study(s), or receiving other investigational agent(s)
* Any condition that may jeopardize study participation (e.g., abnormal clinical or laboratory finding) or interpretation of study results, or may impede the ability to obtain informed consent (e.g., mental condition)
A Study to Confirm the Efficacy and Safety of Fludarabine Phosphate Administered in Untreated Chronic Lymphocytic Leukemia Patients With Anemia and/or Thrombocytopenia

The purpose of this study is to confirm the efficacy and safety of fludarabine phosphate administered with dose increasing in 6 cycles (1 cycle: 5 treatment days every 28 days) in untreated chronic lymphocytic leukemia (CLL) patients with anemia and/or thrombocytopenia.

As of 29 May 2009, the clinical trial sponsor is Genzyme Corporation. NOTE: This study was originally posted by sponsor Schering AG, Germany, which was subsequently renamed to Bayer Schering Pharma AG, Germany.

Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically or cytologically confirmed CLL
* Patients with hemoglobin concentration and/or platelet count below the institution's lower limit of normal
* Patients who have not received cancer chemotherapy or radiotherapy

Exclusion Criteria:

* Patients with apparent infections (including viral infections)
* Patients with serious complications (heart, liver, or kidney disease, etc.)
* Patients with a serious bleeding tendency (e.g., DIC)
* Patients with serious CNS symptoms
* Patients with fever \>= 38°C (excluding tumor fever)
* Patients with interstitial pneumonia or pulmonary fibrosis
* Patients with active multiple cancers
* Patients receiving other investigational products within 6 months before registration in this study
* Patients with prior allergies to medications that are similar to the investigational product (purine nucleoside derivatives)
* Women who are pregnant, of childbearing potential, or lactating
Home Rehabilitation Using Smart Wearable Exercise and Electrical Stimulation Device After Anterior Cruciate Ligament Reconstruction

The purpose of this study is to develop and apply a rehabilitation program for patients who are discharged after ACL reconstruction using a wearable joint rehabilitation exercise device (exoRehab).

This randomized, single-blind, controlled trial included 40 patients who are discharged after ACL reconstruction.

The intervention group(n=20) was instructed and educated about 6 week home rehabilitation program using a wearable device(exoRehab)

The controls(n=20) was instructed and educated about 6 week conventional home rehabilitation program

Two weeks after surgery and six weeks after discharge, evaluation is performed.

The purpose of this study is to develop and apply a rehabilitation program for patients who are discharged after ACL reconstruction using a wearable joint rehabilitation exercise device (exoRehab).

Eligibility Criteria:
Inclusion Criteria:

* Patients with anterior cruciate ligament reconstruction
* Patients who are older than 19 years of age

Exclusion Criteria:

* History of surgery or traumatic injury to the uninvolved lower extremity
* Complication after ACL reconstruction surgery
* Dermatological conditions affecting the thigh
* Body mass index (BMI) greater than 40 kg/m2
* Implanted pacemakers or defibrillators
* Significant neurologic impairments
* Other unstable lower-extremity orthopedic conditions
* Initiated rehabilitation at another facility prior to their first physical therapy session at our facility
* Other lower limb impairment affecting function
* More than one surgery for a tear of the ACL
An Evaluation of a Public Health Campaign in a High School Setting Targeting Pain Related Knowledge and Beliefs

The beliefs held by students lead to behaviours in response to their pain which can be both helpful or a hindrance to how they manage their pain. The one-day education event aims to educate the cohort on the contemporary scientific understanding of persistent pain. It is hoped this event will result in an improvement in the alignment of beliefs and behaviours to contemporary understanding of persistent pain.

The principal aim is to evaluate the pre-post beliefs about pain following a one-day pain education event.

The students will be asked to complete two questionnaires relating to their understanding of pain. One at the start of the conference and one at the end . The first questionnaire will gather demographic information (age, gender, ethnicity and any history of persistent pain). The following questions will be a series of multiple-choice questions relating to beliefs about persistent pain. The second questionnaire to be completed at the end of the day will be identical to the first, minus the demographic questions. Each questionnaire should take 5-10 minutes to complete. So total involvement in this study will be less than 20 minutes. The questionnaires will be provided in an unmarked brown envelope. The envelope will contain two questionnaires one marked "before" and one marked "after". Participants will be asked to complete the "before" questionnaire at the start of the day and then put it back in their envelope. At the end of the day, they will be asked to complete the "after questionnaire". Participants will keep the envelope with them during the day and at no point will their name or any other identifiable information go on the form. At the end of the day, they will be asked to leave the anonymous envelope in a designated area in the room.

Eligibility Criteria:
Inclusion Criteria: students at one of six schools in Berkshire who had been offered the pain study day.

Aged above 16. Providing consent to participate.

Exclusion Criteria:

Students not providing consent.
To Evaluate Sperm Parameters in Men With Secondary Hypogonadism Previously Treated With Topical Testosterone

The study was designed to determine if Androxal® would affect sperm parameters (count, concentration, volume) in men with secondary hypogonadism who have been previously treated with topical testosterone.

The study was designed to determine if Androxal® would affect sperm parameters (count, concentration, volume) in men with secondary hypogonadism who have been previously treated with topical testosterone. A maximum of twelve subjects per group were randomized to daily treatments of Androxal® or topical testosterone (Testim®) for six months. The protocol was later amended to include a treatment group who received Androxal after a 3 month wash out period.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adult males between 21 and 60 years of age who have been diagnosed with AIHH.
* Subjects must have been treated with a topical testosterone replacement therapy (typically AndroGel® or Testim®) for at least 6 months at enrollment and for not more than 2 years.

Exclusion Criteria:

* A history of idiopathic infertility due to primary hypogonadism, testicular failure, Kallmann's syndrome or any other infertility condition.
* Subjects demonstrating any clinically significant medical condition rendering the subjects infertile or marginally fertile other than AIHH.
* Men with a history of, known, or suspected prostate disease not ruled out by a prostate biopsy, or a prostate specific antigen (PSA)\>3.6 or clinical suspicion of current prostate disease.
* Men with a hematocrit in excess of 50 % or hemoglobin \>17 g/dl
Effect of Acupuncture on Heart Rate Variability in Multiple Sclerosis

The Objective of this study is to evaluate the heart rate variability in individuals with multiple sclerosis during the applicability of Acupuncture, to analyze the behavior of the autonomic nervous system before, during, and after therapy and the changes of the condition.

A double-blinded randomized sham-controlled crossover trial with a 1:1 allocation ratio will be conducted, 40 individuals without previous illness will be evaluated, who will constitute the control group and 40 individuals with MS will constitute the experimental group, paired by age and gender. All participants will undertake active or sham acupuncture sessions. Active-Sham group will start with 5 sessions (1 per week) of active acupuncture combined with HRV evaluation for 20 min. After a 2-week washout, this group will be reallocated to another 5 sessions (1 per week) of sham acupuncture for 20 min combined with HRV evaluation. Meanwhile, Sham-Active group will carry out the opposite protocol, participants will start an allocated 5 sessions (1 per week) of sham acupuncture combined with HRV evaluation, and after a 1-week washout period will be reallocated to 5 sessions (1 per week) of active acupuncture combined with HRV evaluation.

Eligibility Criteria:
Inclusion Criteria:

* Individuals diagnosed with Multiple Sclerosis
* Aged over 18 years
* Motor and intellectual capacity to understand the evaluations
* Light and moderate functional classification levels (EDSS scale)
* Who accept to participate in the study through agreement with informed consent form

Exclusion Criteria:

* Do not understand the evaluations
* Cardiac diseases that impede the assessment of HRV
* Have a cardiac pacemaker.
Quality Control for Chronic Obstructive Pulmonary Disease

This is a 1 year longitudinal study to establish a related index system for chronic obstructive pulmonary disease(COPD) quality control.Clinical and economic data of COPD patients will be collected and analyzed.

Sixteen hospitals in Guangdong Province were randomly divided into control group and intervention group.Doctors and nurses of intervention group were trained treat chronic obstructive pulmonary disease according to the GOLD(Global InitiaTive of Chronic Obstructive Lung Disease) guidelines，while those in the control group will not receive any training from research team. Hospital patient cohort and outpatient cohort will be setted. Subjects were interviewed and received pulmonary function tests.All patients will be followed and events of acute exacerbation will be recorded.Factors that influence patient prognosis and economic-health benefits will be analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Patients was diagnosed as COPD according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines older than 40 years old.Patients was hospitalized for AECOPD or visiting outpatient department for COPD.

  * A signed and dated written informed consent is obtained prior to participation.
  * Able to comply with the requirements of the protocol and be available for study visits over 1 years.

Exclusion Criteria:

A COPD subject will not be eligible for inclusion in this study if any of the following criteria apply:

* Known respiratory disorders, or disorders identified at screening/visit

  1 (including identification on the first CT scan), other than COPD (e.g.: lung cancer, sarcoidosis, tuberculosis, lung fibrosis, cystic fibrosis)
* Having undergone lung surgery (e.g. lung reduction, lung transplant)
* Severe liver and kidney dysfunction
* Have cancer or have had cancer in the 5 years prior to study entry
* Taking part in a blinded drug study
The Effects of a Weight Management Program on Body Weight and Quality of Life

Evaluate the impact of a 12-week behavioral weight management program on body weight and quality of life. We hypothesize that participants will lose body weight and see improved quality of life after program completion.

This study will evaluate weight change and quality of life among individuals after completion of a 12-week comprehensive group weight management program. Findings from this study will also help with program development and improvement within our center. The already established weight management program is called Healthy Habits for Life (HHL) and includes a total of 14 visits (one individual visit both before and after the 12 group sessions).

All patients who are enrolled in the Healthy Habits for Life group program at the Weight Center have an individual visit with a registered dietitian prior to beginning the group as part of standard care. At this visit the dietitian will obtain informed consent for participation in the research study and provide subjects consenting to participate in the study with the IWQOL-lite quality of life questionnaire.

After completion of the 12 HHL group sessions, all patients at the Weight Center have another individual visit with the dietitian to review weight and behavior changes since the initial evaluation. At this visit, subjects participating in the research study will again be provided with the IWQOL-lite questionnaire to fill out.

Eligibility Criteria:
Inclusion Criteria:

* English speaking adults aged 18 or older
* BMI ≥ 25
* Enrolled in HHL program at the MGH Weight Center

Exclusion Criteria:

* Non-English speaking patients
Effect of an Opioid Disposal Pouch Versus Usual Care on Post Discharge Disposal of Unused Medication

The purpose of the study is to determine if opioid disposal bags/pouches are an effective method for disposing of unused opioid medications postoperatively

Opioids are dispensed regularly to manage postoperative pain in patients undergoing surgery in hospitals and same day surgery centers. There has been a rise in the number of opioid misuse and overdoses nationally, with Ohio ranked first in the nation for drug overdose deaths in 2014 and Cuyahoga County leading the state with 666 overdose deaths in 2016(ref) As health care providers, it is our responsibility to respond to this epidemic. One measure to address this is to reduce the number of unused prescription opioids that remain in patients' possession when they no longer need them. (ref) Doing so will maximize safety by decreasing the availability of unused opioids. The purpose of this study is to determine if a product that deactivates opioids will be used as designed after oral opioid medication is no longer needed. The design of this study is a quality initiative project using a randomized control design. The setting is a surgery center in a suburban hospital in Cuyahoga County. The population is all adult surgery center patients that are prescribed opioids postoperatively who are discharged the same day. In addition to usual care, a medication disposal bag with instructions on how to use will be given to the patient prior to discharge. The patient will be called 30-45 days post discharge. The data will be collected on a case report form that will include information about disposal and information obtained from the patients medical record.

Eligibility Criteria:
Inclusion Criteria

* Adults (\>18 years)
* Scheduled to go home on the day of surgery
* Received a prescription for opioids
* Willing to provide a telephone number and receive a phone call 30 days after surgery

Exclusion Criteria

* Moderate to severe cognitive decline requiring caregiver support
* Not able to speak or understand English (instructions only available in English)
* Behavioral health diagnosis
Application of Rapid Rehabilitation Nursing in Perioperative Rehabilitation of Knee Arthroscopy

The purpose of this study is to apply the concept of rapid rehabilitation nursing in the perioperative period of knee arthroscopy, to make up for the gap in this field, to provide reference basis for the general colleagues, promote the development of perioperative rapid rehabilitation nursing of knee arthroscopy, accelerate the rehabilitation of patients.

This study aims to apply rapid rehabilitation nursing concept to the arthroscopic perioperative nursing, used to make up for the blank in this field, provides the reference for the overwhelming majority of peer, prompt the arthroscopic perioperative rehabilitation nursing development, accelerate the patient rehabilitation in January 2020 - December 2020 in Beijing a third rate sports medicine hospital be in hospital, to line the arthroscopic surgery patients as the research object, adopt the method of prospective, randomized, controlled in 220 patients. Inclusion criteria: \< 60 age 18 years old, patients with informed consent and voluntary participation in arthroscopic anterior cruciate ligament reconstruction under external anesthesia were excluded from this study: patients with mental system diseases or communication disorders; Patients with metabolic diseases such as diabetes; Patients who could not quit smoking and drinking alcohol before surgery as required; Patients with gastrointestinal tract disease research object were randomly divided into experimental group and control group, control group given conventional perioperative nursing, the experimental group to implement rapid rehabilitation program, the specific implementation process, see table 1 and table 2, compare two groups of preoperative postoperative self-care ability score (Barthel index) 、 the degree of postoperative pain numerical rating scale (NRS 0-10 score) 、the degree of comfort (Likert 1-5 rating score) and rehabilitation completion -Range of motion(ROM) score difference; The safety index was the occurrence of postoperative complications such as nausea, vomiting, dizziness, headache and urinary retention, and the occurrence of postoperative complications such as hypothermia after lower extremity deep venous thrombosis (preoperative and postoperative comparison of erythrocyte sedimentation rate(ESR)、C-reactive protein（CRP） and procalcitonin indexes in blood routine

Eligibility Criteria:
Inclusion Criteria:

* Arthroscopic anterior cruciate ligament reconstruction was performed under epidural anesthesia
* The patients consented and volunteered to participate in this study

Exclusion Criteria:

* Patients with mental disorders or communication disorders
* Patients with metabolic diseases such as diabetes
* Patients who could not quit smoking and drinking alcohol before surgery as required
* Patients with gastrointestinal disorders
* Patients who are not under epidural anesthesia
A Study of Ruxolitinib in Combination With Capecitabine in Subjects With Advanced or Metastatic HER2-negative Breast Cancer

This was a randomized, double-blind, placebo-controlled phase 2 clinical trial comparing the overall survival of women with advanced or metastatic HER2-negative breast cancer who received treatment with capecitabine in combination with ruxolitinib versus those who received treatment with capecitabine alone.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed HER2-negative adenocarcinoma of the breast
* Locally advanced (Stage 3B) or metastatic (Stage 4) disease
* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
* Received up to 2 prior chemotherapy regimens (not including neoadjuvant/adjuvant therapy) for advanced or metastatic disease
* Participants with hormone-receptor positive tumors must have failed available lines of hormonal therapy unless hormone therapy was not tolerated or not clinically appropriate
* ≥ 2 weeks elapsed from the completion of previous treatment regimen and must have recovered or be at a new stable baseline from any related toxicities
* Radiographically measurable or evaluable disease
* An mGPS of 1 or 2 as defined below:

  * Criteria:

    1. modified Glasgow prognostic score (mGPS) of 1: CRP \> 10 mg/L and albumin ≥ 35 g/L
    2. mGPS of 2: C-reactive protein (CRP) \> 10 mg/L and albumin \< 35 g/L

Exclusion Criteria:

* Received prior treatment with capecitabine or fluoropyrimidine for advanced or metastatic disease
* Received more than 2 prior regimens for advanced or metastatic disease (not including hormonal therapy in the metastatic setting or neoadjuvant or adjuvant therapies)
* Unknown hormone-receptor status
* Ongoing radiation therapy or radiation therapy administered within 2 weeks of enrollment
* Concurrent anticancer therapy
* Inadequate renal, hepatic or bone marrow function
* Another current or previous malignancy within 2 years of study entry unless approved by the sponsor