cyrilzakka/clinical-trials huggingface dataset:
A Comparison: High Intense Periodic vs. Every Week Therapy in Children With Cerebral Palsy (ACHIEVE)

The ACHIEVE study is a comparison of the effectiveness of 2 intensities of physical therapy treatment for children with Cerebral Palsy in an outpatient physical therapy setting. High intensity periodic is 2 hours of focused and high intense treatment per weekday for 4 weeks. In comparison, usual weekly is considered standard of care; although both dosing models are used clinically for children with CP. Participants are assign to the treatment group at random. Participant who are unable to consent to randomization are allowed to chose a treatment group.

The overall goal of this project is to compare the effectiveness of high intense periodic and usual weekly therapy in treating Cerebral Palsy (CP) in children 2-8 years of age for motor rehabilitation. In this prospective randomized controlled trial (RCT), 108 children ages 2 to 8 years of age with CP will be enrolled and assigned to one of 2 service delivery models: 1 hour per day, 1 x per week for 40 weeks (usual weekly); and 2 hours every weekday for two 10-consecutive-weekdays (total 4 weeks), for a repeated "periodic" bout (high intense periodic). Participants unable to consent to randomization are allowed to chose a treatment group. All patients enrolled in ACHIEVE will also have 1 hour per month of Physical Therapy Consultation (PTC) during the treatment period of 40 weeks (9 months). PTCs provide monthly motor skill monitoring, consultation, and home therapy program progression. Outcome evaluations will be performed by blinded evaluators at baseline (month 0, before treatment), month 9 for all patients to assess short term effects, and at months 12 and 18 for patients to assess long term effects. Parent surveys will be collected at 0, 4.5, and 9 months only (PC-2). Short-term and long-term effects will be analyzed to determine individual differences in children's response to intensity. A subset will be analyzed at 12 and 18 month.

Eligibility Criteria:
Inclusion Criteria:

* 2 to 8 years of age at initiation of treatment
* a diagnosis of motor delay or CP in GMFCS levels 1-V
* ability to tolerate a 2 hour therapy session based on parent report and evaluating therapists.

Exclusion Criteria:

* uncontrollable seizures or any co-morbid condition that prevents full participation during treatment sessions
* participation in another daily treatment program in the last 6 months
* auditory or visual conditions that prevent full participation during treatment sessions
* Progressive neurological disorder with no potential for improvement.
* Recent surgery where physical therapy is contraindicated.
Efficacy Evaluation of Hydrolyzed Collagen Peptide on Knees, Hips, and Ankle Pain in Osteoarthritis

The aim of this study is to evaluate the effectiveness of Hydrolyzed collagen peptides on joint pain, stiffness and physical function in adults with osteoarthritis who have complaints on knee joints together with hip and ankles. The assessment of improvements on volunteers' quality of life, and safety and tolerability of the product is the other objective of this placebo-controlled, randomized study.


Eligibility Criteria:
Inclusion Criteria:

1. Male and female individuals with osteoarthritis on knee who are aged between 45-60 years old,
2. Who are not drug-naïve to osteoarthritis and related conditions,
3. Volunteers who have ability to communicate adequately with the investigator and in agreement to comply with the study requirements,
4. Volunteers who have normal blood pressure and heart rate measured under stabilised conditions at the screening visit after at least 5 minutes of rest under supine position: SBP within 100 to 140 mmHg, DBP within 60 to 90 mmHg and HR within 50 to 100 bpm at least after 5 minutes of rest,
5. Volunteers who have understanding of the study and agreement to give a written informed consent.

Exclusion Criteria:

1. Who have atopic constitution or asthma and/or known allergy for bovine derived collagen products and/or other any of the excipients of the product.
2. Who have hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucosegalactose malabsorption.
3. Who have an active rheumatoid arthritis or any other inflammatory arthritic condition that researchers consider non appropriate.
4. Who have Diabetes Mellitus.
5. Who have the use of oral retinoids or oral steroids in the 6 months prior to initiation of the study.
6. Who have current participation in another clinical study, or participation in a relevant study within 3 months.
7. Who have any history or presence of serious or life-threatening conditions of cardiovascular, neurological, haematological, hepatic, gastrointestinal, renal, pulmonary, endocrinological, metabolism or psychiatric disease, any type of porphiria.
8. Who have the presence or history of malabsorption or any gastrointestinal surgery except appendectomy or except herniotomy.
9. Who are planned to go or already went under a joint-related reconstructive surgery,
10. For female volunteers, who had undergone, or planned to undergo, pregnancy or breastfeeding.
11. Who have current or regular intake of NSAIDS, contraceptives, hormones, obesity drugs, absorption inhibitors or antidepressants
12. Who are suspected to have a high probability of non-compliance to the study procedure and/or completion of the study according to the investigator's judgment.
13. Who have history of drug abuse.
14. Who have relationship to the investigator.
15. Who are not suitable to any of inclusion criteria.
16. Who have history of difficulty of swallowing.
Negative Pressure Ventilator in Long-term Pulmonary Rehabilitation for Chronic Obstructive Pulmonary Disease

Chronic obstructive pulmonary disease (COPD) is characterized by irreversible airflow obstruction with chronic airway inflammation and emphysematous changes in the lung parenchyma, thus leading to air-trapping, as well as extional dyspnea. The investigators have previously observed that NPV used as an adjuvant to pulmonary rehabilitation improves lung function, exercise capacity, and reduces exacerbations. The investigators now sought to determine whether long-term maintenance NPV improves long-term clinical outcomes and reduces mortality in COPD.

Chronic obstructive pulmonary disease (COPD) is characterized by irreversible airflow obstruction with chronic airway inflammation and emphysematous changes in the lung parenchyma, thus leading to air-trapping, as well as extional dyspnea. The mechanism underlying desaturation during 6MWT in patients with COPD is multifactorial involving dynamic hyperinflation and impaired gas exchange that worsens ventilation-perfusion mismatch. Previous studies have shown that oxygen desaturation during the 6MWT predicts mortality and increases the risk of adverse outcomes in COPD patients. However, there is a paucity of studies that have looked at effective treatments to counter the consequences of hypoxemia during exertion.

The investigators have established a hospital-based maintenance pulmonary rehabilitation program together with NPV for COPD, and the investigators have shown that the benefits of NPV improves lung function and exercise capacity, and reduces acute exacerbation and medical costs. The investigators now sought to determine whether long-term maintenance NPV improves long-term clinical outcomes and reduces mortality in COPD.

Eligibility Criteria:
Inclusion Criteria:

* Main diagnosis of Chronic Obstructive Pulmonary Disease
* Stable status at enrollment
* Able to come to pulmonary rehab center

Exclusion Criteria:

* Infection or acute excerbation condition at enrollment
* Severe neuromuscular, cardiac disease or dementia
* Unable to perform six minute walk test
A Brief Intervention for Patients on Opioids for Acute Pain

This study aims to evaluate benefits of a brief intervention for patients who are prescribed opioids for acute pain.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are admitted to Henry Ford Hospital
* Patients who have been evaluated by the Psychosomatic Medicine Service
* Patients who are prescribed at least one opioid for an acute pain condition

Exclusion Criteria:

* Patients taking an opioid for a chronic pain condition within the previous year
* History of an opioid use disorder.
Feasibility Study to Assess the Safety and Functionality of the GluSense Continuous Glucose Monitor in Diabetic Patients

Currently marketed CGM sensors have an approved functional lifetime of up to 1 week. Pre-clinical studies have demonstrated that GluSense-LTone 2e3 sensors may be used to accurately monitor glucose levels for 30 days. The purpose of this study is to assess the safety and functionality of the device in human patients for consecutive 15 days.

GluSense-LTone 2e3 as long term CGM, will require less sensor replacements and calibration, meaning less patient interventions, and is therefore will be much more user friendly. Moreover, GluSense-LTone 2e3 shows potentially increased accuracy, especially in the critically important hypoglycemic range, meaning that better management of patient's condition may be attained.

GluSense-LTone 2e3 is a continuous glucose monitoring (CGM) system. It is a semi-invasive, optical fiber-based device with a lifetime of up to one month. The purpose of this study is to assess the safety, accuracy, calibration requirements and effective lifetime of the device.

Eligibility Criteria:
Inclusion Criteria:

Patients must meet all of the following inclusion criteria to be eligible for participation in this study:

* Male or female patients between 18 and 50 years of age
* Patients with type 1 diabetes mellitus.
* The ability to read, understand and sign an informed consent form. Written consent must be obtained prior to initiation of study procedures

Exclusion Criteria:

Patients who meet any of the following exclusion criteria are not to be enrolled in this study:

* Clinical significant illness that can compromise patient's health during study such as:

  * Significant current heart disease
  * Significant Liver or kidney disease
  * HIV infection
  * Hepatitis B or Hepatitis C infection
  * Malignancy
  * Major allergic skin disease including plaster allergies
  * Significant allergic disorders
* Current or recent significant skin conditions (e.g. eczema, psoriasis,).
* Presence of skin markings/ abnormalities around implantation site that will interfere with the skin assessment e.g. tattoos, piercings, birthmark, sunburn
* Current alcohol or substance use judged by the IP to potentially interfere with patient study compliance.
* Routine administration of Steroid based medications.
* Patients currently taking part in any other clinical trial using an investigational product within the last 3 months
The Excess Opioid Disposal Study

This study is designed to test the hypothesis that providing information to patients about excess opioid disposal, calling patients prior to their outpatient post-operative surgical appointment and providing a convenient drop box for opioid disposal will increase rates of FDA compliant disposal.

It is hypothesized that:

1. By providing pre-operative patient education, a drop-box in a convenient location (the hospital pharmacy near the surgical outpatient clinic) and a reminder phone call prior to the post-operative clinic appointment, an increase in FDA-compliant unused opioid disposal rates to at least 40% will be seen.
2. The investigator's guideline for opioid prescribing after operations that require an inpatient admission which the investigator established for general surgical procedures will satisfy the opioid requirements of at least 85% of patients undergoing a variety of operations from differing specialties.
3. The utilization of guideline opioid prescribing and FDA-compliant unused opioid disposal will decrease the percentage of patients who are taking opioids at 6 months and 1 year after their surgery to less than 1%.

The primary objective is to determine the effect of pre-operative patient education, a drop-box in the hospital pharmacy and a reminder phone call on the proportion of patients who dispose of unused opioids using a FDA-compliant method.

Secondary objectives include:

1. Determine in a prospective study whether our guideline for opioid prescribing after surgery which requires inpatient admission fulfills the opioid requirements of at least 85% of patients undergoing a variety of operations.
2. Determining the effect of guideline opioid prescribing and FDA-compliant unused opioid disposal on the proportion of patients who are on opioids 6 months and 1 year after their surgery.

Eligibility Criteria:
Inclusion Criteria:

* Having surgery with expected duration of admission of 2 days or more

Exclusion Criteria:

* Allergies to opioids
* Allergy or contra-indication to short term acetaminophen or ibuprofen
* Chronic opioid use
* History of opioid abuse
OsciPulse D-dimer Pilot Trial

Pilot, randomized, non-blinded clinical trial to generate preliminary data to evaluate the impact of the OsciPulse system on serum d-dimer levels compared to standard of care intermittent compression therapy for DVT prophylaxis in patients admitted in the neuro ICU or intermediate neurological care unit with acute ischemic stroke.

This is a single site, randomized open label two arm study. The patient population will be randomly divided into two arms, with one receiving the OsciPulse System and the other receiving standard intermittent compression therapy.

Both arms will have the therapy applied within 24 hours of admission and continue during their hospital stay until day 7 or discharge, whichever is shorter, unless clinically required to be removed. Daily d-dimer levels will be assessed until day 7 or discharge. If required beyond day 7, standard compression therapy will be provided. An interim analysis will be performed after 20 subjects are enrolled to evaluate the speed of enrollment and data variability and quality. If indicated, enrollment will be increased up to 40.

Eligibility Criteria:
Inclusion Criteria:

1. Adult aged ≥ 18 years old
2. Admitted to the Neuro Intensive Care Unit or Intermediate Neuro Care Unit with a diagnosis of ischemic stroke
3. Last known normal \< 24 hours.
4. NIH stroke score ≥5
5. Weakness in at least one leg (≥ 1 point on the NIHSS lower extremity motor scores)
6. Prescribed mechanical therapy for DVT prophylaxis.

Exclusion Criteria:

1. Inability or contraindication to applying IPC to both legs such as:

* Evidence of acute bone fracture in lower extremities
* Acute burns in the lower extremities, lacerations, ulcers, active skin infection or dermatitis, in the lower extremities at the site of IPC placement
* Acute ischemia or severe peripheral vascular disease in the lower extremities as evidenced by cyanotic, cool, pulselessness.
* Amputated foot or leg on one or two sides
* Compartment syndrome (acute injury causing swelling and ischemic injury)
* Severe lower extremity edema (+4 edema as documented by clinical team)
* Acute deep vein thrombosis 2. Subjects who received thrombolytic therapy (e.g. Alteplase or Tenecteplase) for their stroke 3. Known pregnancy or within 6 weeks of postpartum period. 4. Limitation of life support, life expectancy \< 7 days, or in hospice care 5. A head-unit is unavailable within 24 hours of last known normal. 6. At the discretion of the attending physician and / or clinical team, the subject's participation in the study is believed not to be in the best interest of the subject.
Pharmacokinetics of Boceprevir in Pediatric Subjects With Chronic Hepatitis C Genotype 1 (P07614)

This is a study to determine the pharmacokinetics (PK) and weight-based dose of boceprevir following single oral dose administration in Chronic Hepatitis C Virus (HCV) pediatric participants.


Eligibility Criteria:
Inclusion Criteria:

* Documented chronic hepatitis C (CHC) genotype 1 infection
* Treatment naïve or failed previous interferon/ribavirin therapy (≥12 uninterrupted weeks)
* Weigh between 10 kg to 90 kg inclusive at screening and baseline (Day -1).
* Body Mass Index (BMI) from the 5th to the 95th percentile for the participant's age and gender, inclusive, per tables from the Center for Disease Control and Prevention, USA
* Use of acceptable methods of contraception for at least 3 months prior to baseline and continue on study

Exclusion Criteria:

* Co-infection with the human immunodeficiency virus (HIV) or hepatitis B virus (HBsAg positive).
* Treatment with ribavirin within 90 days, or any interferon-alfa within 30 days
* Discontinued from interferon treatment due to adverse events
* Currently receiving antiviral/immunomodulating therapy for hepatitis C
* Prior treatment with an HCV protease inhibitor
* Prior treatment with any known hepatotoxic agent (including herbal remedies)
* Use of investigational drugs within 30 days of enrollment into study
* Evidence of de-compensated liver disease including, but not limited to, a history or presence of clinical ascites, bleeding varices, or hepatic encephalopathy.
* Substance abuse (including but not limited to alcohol abuse, illicit drugs,

inhalational drugs, marijuana use, etc) any time prior to entry into the study

* Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of any drug.
* Pregnant or breastfeeding female
* Meeting any of the laboratory exclusion criteria
Surveillance Study to Assess the Safety of Flublok Quadrivalent (Influenza Vaccine) in Pregnant Women and Their Offspring

Primary Objective:

To evaluate the safety of Flublok Quadrivalent influenza vaccine in pregnant women included in the VAP00003 Study (NCT03694392) and their offspring exposed during pregnancy or up to 28 days preceding the estimated date of conception with regards to pregnancy, birth, and neonatal/infant outcomes

Secondary Objective:

Data will be recorded prospectively during the safety follow-up for pregnant women until delivery (or pregnancy outcome, whichever is later), and for infants of pregnant women for 1 year after birth.

Eligibility Criteria:
Inclusion criteria

Pregnant women:

* Laboratory or medical professional confirmation of pregnancy
* Exposure to either Flublok Quadrivalent influenza vaccine or standard-dose quadrivalent inactivated influenza vaccine (SD-IIV4) in the VAP00003 Study during pregnancy or within 28 days preceding conception

Offspring:

* Infants delivered by pregnant women who satisfy the criteria above Exclusion criteria
* Documented receipt of any other influenza vaccine at any other time during the pregnancy

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Validation of a Personalised Medicine Tool for Multiple Myeloma That Predicts Treatment Effectiveness in Patients

The consortium aims to commercialise the MMpredictor as a personalised medicine tool that predicts the most effective treatment strategy for individual Multiple Myeloma (MM) patients. MM is the second most common form of blood cancer contributing to 15% of all blood cancers and \~1,5% and 2% of all cancer deaths annually in the EU and US, respectively.

Patients show a large variability in treatment response and side effects due to tumour heterogeneity and the patient's intrinsic characteristics. Therefore, not every treatment will be suitable for each patient, and treatment strategies are often based on trial-and-error. The availability of multiple (\>20) treatment options complicates treatment decision-making even more. With the current development of many more promising treatments, there is an urgent unmet clinical need for a diagnostic assay that supports personalised cancer treatment in order to improve patient health outcomes, prevent side effects and reduce healthcare costs.

SkylineDx has previously developed the MMprofiler, a microarray-based diagnostic test that can subtype MM patients and reliably predict MM patient survival (prognosis). In this project, the test's clinical value will be expanded to include the prediction of treatment effectiveness in individual patients based on Gene Expression Profiling. An addendum for new intended use will be filed to the current in vitro diagnostic (IVD) registration, while renaming the test to MMpredictor. The project will also focus on positioning the test as a cost-effective IVD test for personalised medicine, that will increase health outcome and quality of life of patients and reduce healthcare costs.

The consortium consists of a life science SME specialised in molecular diagnostics, clinical centres with world renowned KOLs, a leading health economic institute, and a European MM patient advocacy organisation combining all the required complementary expertise to successfully bring the MMpredictor to market.


Eligibility Criteria:
Inclusion Criteria:

* The bio-banked MM patient samples and clinical data will be obtained from previous European clinical trials that have been conducted over the past 5 years within the participating clinical centres and other clinical centers. The samples were not collected for the purposes of this project. The subjects from which the data was initially taken cannot be identified from the data/records. However, the patients from the above mentioned trial have explicitly consented for the use of their samples for other (future) clinical research purposes.

Exclusion Criteria:

-
Study of Conventional Laparoscopic Hysterectomy Versus Robot-Assisted Laparoscopic Hysterectomy at a Teaching Institution

Approximately 600,000 women undergo hysterectomy each year in the United States, of which 12% are laparoscopic. The most common indications for hysterectomy are: symptomatic uterine leiomyomas (40.7%), endometriosis (17.7%), and prolapse (14.5%). The first total laparoscopic hysterectomy was performed by Reich et al in 1988. Many studies have proven that laparoscopic hysterectomy is associated with lower preoperative morbidity, shorter hospital stay, and shorter recovery times than abdominal hysterectomy. The literature has also shown the complication rates for laparoscopic cases are similar to open procedures in the hands of an experienced laparoscopic surgeon. The American Congress of Obstetricians and Gynecologists Committee on Gynecologic Practice state that laparoscopic hysterectomy is an alternative to abdominal hysterectomy for those patients in whom vaginal hysterectomy is not indicated or feasible. The ACOG Committee on Gynecologic Practice site multiple advantages of laparoscopic hysterectomy to abdominal hysterectomy including faster recovery, shorter hospital stay, less blood loss, and fewer abdominal wall/wound infections. Despite the recommendations of ACOG for a more minimally invasive approach, 66% of all hysterectomies are performed abdominally. Key reasons for the lag in utilization of laparoscopic techniques are the technical obstacles of performing minimally invasive hysterectomies. Robotic technology has emerged as a means to decrease the learning curve and increase the availability of minimally invasive surgery to patients. A current review of the literature reveals no randomized trials evaluating the efficacy of conventional laparoscopic hysterectomy vs. robot-assisted laparoscopic hysterectomy. The investigator's aim is to address this void.

The primary objective of this study is to determine whether Robot-Assisted Laparoscopic Hysterectomy is equivalent to Conventional Laparoscopic Hysterectomy with respect to operative time, blood loss, and hospital stay. The investigator's secondary objective was to assess the cost, morbidity, and mortality of each procedure.

See Above

Eligibility Criteria:
Inclusion Criteria:

* Individuals recruited into this study will be patients presenting to the Urogynecology and Minimally Invasive Surgical Group for consultation for hysterectomy.

Exclusion Criteria:Individuals who are not candidates for laparoscopic surgery

* Medical Condition that does not allow pneumoperitoneum
* Medical Condition that does not allow proper ventilation during anesthesia
* Uterine size precluding access to the uterine artery
* Pelvic Organ Prolapse amendable to a vaginal approach