cyrilzakka/clinical-trials huggingface dataset:
Early Access Program for ALXN1840 in Patients With Wilson Disease

This is an open-label, single-arm, multi-center EAP, designed to provide early access to ALXN1840 for eligible patients with WD.

To provide access to ALXN1840 treatment, an investigational medicinal product (IMP) that has not yet been granted marketing authorization, to participants who complete Studies ALXN1840-WD-205, WTX101-301, or ALXN1840-WD-302, or other studies with ALXN1840 who, in the opinion of the Treating Physician, may benefit from continued treatment with ALXN1840, and who meet the eligibility criteria described in this protocol.

Eligibility Criteria:
Inclusion Criteria:

1. ≥ 3 years of age or older at the time of providing informed consent/assent and expressed desire to continue treatment with ALXN1840.
2. Confirmed diagnosis of WD.
3. Has completed one of the following ALXN1840 clinical studies:

   1. ALXN1840-WD-205
   2. WTX101-301
   3. ALXN1840-WD-302
   4. Other ALXN1840 studies
4. In the Treating Physician's medical opinion, the potential benefits of treatment with ALXN1840 outweigh the potential risks for the participant.
5. Participant or legal representative provided informed consent/assent to be treated with ALXN1840 through this EAP.
6. Female participants of childbearing potential and male participants must follow protocol-specified-contraception guidance.

Exclusion Criteria:

1. Eligible for and able to participate in an Alexion-sponsored study of ALXN1840.
2. Unwilling or unable to comply with the Treating Physician's treatment plan related to this EAP for any reason.
3. Has decompensated hepatic cirrhosis.
4. Model for End-Stage Liver Disease (MELD) score \> 13.
5. Modified Nazer Score \> 7.
6. End-stage renal disease on dialysis (chronic kidney disease stage 5 \[CKD 5\]) or creatinine clearance \< 30 mL/min.
7. Known hypersensitivity to ALXN1840, ALXN1840 excipients, or any of the ingredients contained in ALXN1840.
8. Women who are nursing or pregnant (or women who are planning to become pregnant during treatment with ALXN1840).
ROSA Knee Intraoperative Planning Flexibility Study

The purpose of this study is to verify that an orthopedic surgical assist robot (ROSA Knee System) can provide intraoperative adjustment of osteotomy angle and volume for total knee arthroplasty (TKA) based on feedbacks obtained from intraoperative soft tissue conditions. A total 80 cases will be enrolled at one study site with a postoperative follow-up period of 2 years.

The objectives of the study are to document that ROSA Knee System can provide intraoperative planning adjustment based on feedbacks obtained by laxity as well as gaps to locally preferred surgeon's operative philosophy. This will also provide accuracy, intraoperative soft tissue release as well as patient outcome on locally preferred surgical technique.

The primary endpoint is defined as the mean absolute difference between X-Atlas image-based pre-op plan \& intra-op final plan.

The secondary endpoints include Kinematic Analysis, EuroQol 5 dimensions (EQ-5D), Rehabilitation record, Knee Society Score (KSS) 2011, image assessment and Safety up to 2 years postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* 20 years and over
* Skeletally matured
* Decision to have Total Knee Arthroplasty with ROSA Knee System being made independently and prior to recruitment into study
* Willing and able to complete scheduled follow-up evaluations as described in the study protocol
* Has participated in the informed consent process and is willing and able to sign an Institutional Review Board (IRB)/Ethics Committee (EC) approved informed consent form

Exclusion Criteria:

* Has serious bone defect(s), which require(s) metallic augment, synthetic bone or allograft
* Is septic, has an active infection or has osteomyelitis at the affected joint
* Has vascular insufficiency, muscular atrophy at the implant site or neuromuscular disease which might jeopardize the outcome of the surgery
* Has any concomitant disease which is likely to jeopardize the functioning or success of the implant
* Is known to be pregnant
* Is a prisoner, known alcohol or drug abuser or mentally incompetent or unable to understand what participation in this study entails
* Has a known sensitivity or allergy to one or more of the implanted materials
Recognition of Abnormal Pediatric Blood Pressures in Primary Care

This study will look at general pediatricians' effectiveness at screening children for elevated blood pressure values in the primary care setting. Two new screening tools will be introduced and their effectiveness will be measured against current practice by way of medical chart review.


Eligibility Criteria:
Inclusion Criteria:

* Health care supervision visit
* Documented measured blood pressure and height
* Between the ages of 3 years and 17 years

Exclusion Criteria:

* Younger than 3 years of age
* Older than 17 years of age
* No documented blood pressure measurement
* Not a health supervision encounter
Is Prolonged Period of Prone Position Effective and Safe in Mechanically Ventilated Patients With SARS-COV-2?

the aim of the study is to assess safety and efficacy of prone position ventilation beyond the usual 16 hrs in patients with SARS-COV-2


Eligibility Criteria:
Inclusion Criteria:

* - American Society of Anesthesiologists (ASA) physical status II- III.
* Sex (male and females).
* Age 18 -80 years.
* Sever adult respiratory distress (ARDS) (defined as a PaO2:FiO2 ratio of \<150 mm Hg, with a fraction of inspired oxygen (FiO2) of ≥0.6, a positive end expiratory pressure (PEEP) of ≥5 CmH2O, and a tidal volume of 6 ml/Kg of predicted body weight
* mechanical ventilation for less than 36 hours

Exclusion Criteria:

* - Contraindication for prone positioning

  * increased intracranial tension.
  * face trauma or surgery.
  * Recent Deep venous thrombosis
  * Unstable spine, femur, or pelvic fractures
  * Mean arterial pressure \< 65 mm Hg
  * Pregnant women
  * Pneumothorax
  * Prone positioning before inclusion
* Those returned to supine position before completing the session time
The Use of Diffuse Optical Spectroscopy to Characterize in Response to Weight-Loss Intervention

The first step in any clinical intervention against obesity involves sustained lifestyle changes. Researcher can use these strategies to beneficial the effects of weight and on cardiovascular risk. The researcher develope methods for assessing the effectiveness use optical technology to make such assessments, specifically in the area of fatty tissue can predict the effectiveness of the intervention in causing weight reduction and treating metabolic disease.

Optical technologies under development at the Beckman Laser Institute.

Diffuse Optical Spectroscopy Imaging is a method for studying absorption and scattering (optical properties) of tissue in humans. It is related to near-infrared spectroscopy , but allows for more quantitative and thorough measurements. The researcher use Diffuse Optical Spectroscopy to measure fatty tissue, water, blood concentration level during weight loss program to determine the effect of sustained changes in weight or relapses.

Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index greater than 25, overweight
* Participation in Weight Loss program

Exclusion Criteria:

* A medical history of myocardial infarction or cerebrovascular stroke
* Pregnancy or planned pregnancy during the course of the study period
Impact of Symbiotic Administration on Intestinal Function of Head and Neck Patients Surgically Treated

The purpose of this study is to determine whether the symbiotic use in patients with head and neck cancer impact on intestinal function after surgical treatment.

The study will be conducted offering the patients symbiotic product twice a day for seven days after the surgical treatment. Patients will be monitored for the number of stools, stools consistency, abdominal pain and gas overproduction.

Eligibility Criteria:
Inclusion Criteria:

* head and neck cancer with primary surgical treatment, enteral nutrition by enteral tube.

Exclusion Criteria:

* three months antibiotic use earlier the surgery, recently radiotherapy or quimiotherapy, inflammatory bowel disease.
To Assess the Effect of Food on the Pharmacokinetics of Selumetinib (AZD6244; ARRY-142886) (Hyd-Sulfate) in Healthy Male Volunteers

Study to assess the effect of food on the Pharmacokinetics of Selumetinib (AZD6244; ARRY-142886) (Hyd-Sulfate) in Healthy Male Volunteers

A randomized, Open-label, Single-center, Crossover Study to Assess the Effect of Food on the Pharmacokinetics of a 75 mg Single Oral Dose of Selumetinib (AZD6244; ARRY-142886) (Hyd-Sulfate) in Healthy Volunteers.

Eligibility Criteria:
Inclusion Criteria: 1. Have a body mass index (BMI) between 18 and 30 kg/m2 (inclusive) and weigh at least 50 kg and no more than 100 kg (inclusive). 2. Must not have smoked or used nicotine products within the previous 3 months. 3. Have a calculated creatinine clearance (CrCL) greater than 50 mL/min using the Cockcroft-Gault formula.

Exclusion Criteria: 1. Current or past history of central serous retinopathy or retinal vein thrombosis, intra-ocular pressure greater than 21 mmHg or uncontrolled glaucoma. 2. Any clinically relevant abnormal findings in physical examination, hematology, clinical chemistry, urinalysis, vital signs, or ECG at baseline in the opinion of the investigator. 3. History or presence of any clinically significant disease or disorder in the opinion of the investigator. 4. Subjects of Japanese or non-Japanese Asian ethnicity. 5. Subjects where any one parent or grandparent (maternal or paternal) is Japanese or non-Japanese Asian (e.g., China, Taiwan, Korea, Philippines, Thailand, Vietnam and Malaysia). Asian Indians are acceptable.
Collaborative Care for Depressed Elderly in Korea

Late-life depression is associated with physical limitations, greater functional impairment, increased utilization and cost of health care, and suicide. Collaborative care, linking primary and mental health specialty care, has been shown to be effective for the treatment of late-life depression in primary care settings in Western countries. The primary aim of this project is to implement a depression care management intervention, and examine its effectiveness on the depressive symptoms of older patients in Korean primary care settings. Based on chronic disease management theory and previous Collaborative care management studies in western countries, we propose to test a Depression Care Management intervention,which includes care manager to support a primary care physician of depression in their old patients. Care manager'd role are monitoring the progress of treatment, supporting patient's adherence, educating patients/ family and facilitate communication between providers. Also psychiatrists provide consultation and supervision of care managers. Using a randomized controlled design, we will examine whether the Depression care management is an effective treatment for patients with late life depression in rural Korea. The primary outcome would be the improvement of depressive symptoms of patients in primary care setting.


Eligibility Criteria:
Inclusion Criteria:

* 60 year or older
* diagnosed depression based on DSM-IV criteria

Exclusion Criteria:

* impairment of hearing
* dementia
* other psychiatric disorders
Pharmacogenetics, Therapeutic Drug Monitoring (TDM) and Active Pharmacovigilance As Innovative Tools Aimed At the Optimisation/ Appropriateness of Drug Therapy

The primary goal of this observational study is to evaluate the feasibility of implementing a multidisciplinary approach based on pharmacogenetics, TDM (Therapeutic Drug Monitoring) and MedReview into the clinical practice in order to optimize the appropriateness of drugs prescription and to minimise the risk of Adverse Drug Reactions (ADRs) in adult cancer patients and in pediatric patients affected by chronic inflammatory diseases. This approach of active pharmacovigilance will also allow a better definition of the causality assessment of ADRs through the direct implementation of data quality in the reporting forms. The study may therefore constitute an example of an approach for both the prevention of ADRs and the optimization of drug use, and for the integration of pharmacogenetics, TDM, and the MedReview data into the National Pharmacovigilance Reports for an improved and innovative evaluation of adverse events, aiming at the implementation of this approach in the regional context.

Primary aim of the study:

To implement the use of pharmacogenetics, TDM, and MedReview at the regional level supporting their utility through an observational approach to assess the effects of these innovative methods, already active in IRCCS, for the optimization of appropriate drug use and minimization of ADR risk in adult and pediatric oncology patients, as well as pediatric patients with chronic inflammatory diseases. Specifically, the aim is to evaluate the incidence of ADRs in patients treated based on pharmacogenetics, TDM, and MedReview compared to historical cases treated according to the standard of care before the implementation of the proposed innovative methodologies.

Secondary aims of the study:

1. To evaluate the "Causality Assessment" between ADR and drug based on the enhanced data quality deriving from the integration of pharmacogenetics, TDM and MedReview into the Pharmacovigilance report.
2. To propose the systematic integration of the results related to pharmacogenetics, TDM, and MedReview within the existing fields of the current ADR reporting form. This aims to develop a proposal for updating AIFA procedures related to the inclusion of this type of evidence-based information in the National Pharmacovigilance Network (RNF), with a potential update of the reporting form.

Eligibility Criteria:
Inclusion Criteria:

Patients who are candidates for therapy with:

* Abemaciclib,
* Palbociclib,
* Ribociclib,
* Letrozole,
* Tamoxifen,
* Olaparib,
* Niraparib,
* Rucaparib,
* Imatinib,
* Sunitinib,
* Sorafenib,
* Regorafenib,
* Lenvatinib,
* Irinotecan,
* Capecitabine,
* 5-Fluorouracil,
* Infliximab,
* Cyclophosphamide,
* Methotrexate,
* Adalimumab,
* 6-Mercaptopurine/Azathioprine
Investigation of the Freespira Breathing System in the Treatment of Post Traumatic Stress Disorder (PTSD)

This study will test the efficacy of the Freespira Breathing System in adults with post traumatic stress disorder (PTSD).

The Freespira Breathing System (FBS) developed by Palo Alto Health Sciences, Inc, is a portable home device , and has been employed in breathing biofeedback in adults with panic disorder (PD). The FBS has received FDA clearance for the treatment of PD adults and is currently commercially available.

This study is a prospective, single arm, un-blinded investigation of the Freespira Breathing System in the PTSD population.

Eligibility Criteria:
Inclusion Criteria:

Note: Office visits required. Patients must live locally in San Francisco/Silicon Valley Bay Area to participate.

Patients with a primary diagnosis of PTSD

* Additional DSM-V disorders are acceptable and will be documented.

  * Subjects over 18 years of age
  * Subjects with a Clinician's Global Impression (CGI-S) score of ≥ 4
  * Subjects with a CAPS-5 score of ≥ 30
  * If on psychotropic medication(s), on a stable dose during the course of treatment
* This can include benzodiazepine use that is prescribed on an as needed basis. • If on psychotropic medication(s), patient agreement to maintain their current stable dose from point of study entry until the 2-month post-treatment assessment.

Exclusion Criteria:

* Subject is pregnant.
* Current enrollment in another device or drug study.
* Enrollment in another drug or device study that is not at least 30 days past the final follow-up visit.
* Currently undergoing cognitive behavioral therapy, or equivalent that is focused addressing PTSD including any evidenced based therapy that focuses on PTSD, including cognitive processing therapy, EMDR, prolonged exposure therapy, Virtual reality therapy, during trial and 2 month follow up. Cognitive therapy must be discontinued 1 month prior to enrolling in this study.
* Severe suicidality, in the judgment of the interviewer and taking the CHART assessment into account
* Psychotic disorder diagnosis, including schizophrenia and schizoaffective disorder
* Presence of uncontrolled bipolar disorder as described below -

  * The subject has experienced a manic episode in the past 6 months and is not considered under control by reviewer
  * Bipolar disorder is considered the primary diagnosis for the subject, in the interviewer's opinion.
* No Alcohol, drug use disorder that requires medical treatment . If stable under medical supervision treatment for drug/alcohol use, then OK
* Cardiovascular or pulmonary disease, such as COPD.

  * Score of ≥ 10 on the COPD assessment
  * EtCO2 of ≥ 48 mmHg at first treatment visit
* Epilepsy or seizures
* Inability to understand or comply with study procedures.
* The investigator feels that for any reason the subject is not eligible to participate in the study.
The Impact of Colorectal Cancer Surgery on Localization of Ureters; Prospective Clinical Trail

To investigate the changes in the anatomical location of ureters after colorectal surgery.


Eligibility Criteria:
Inclusion Criteria:

1. \>18 years old
2. Curative surgery for colorectal cancer diagnosis

Exclusion Criteria:

1. Abnormal renal function
2. Not having the test in accordance with the cancer follow-up program
3. Contrast allergy
4. Any surgery for the ureters in history
A Study of Facilitators and Barriers to Improve Acute Kidney Injury in Children Through Mobile Health Intervention

The purpose of this study is to improve patient-centered care for acute kidney injury (AKI) in order to decrease the adverse health outcomes associated with this common condition.

There is a need to provide better patient-centered care for acute kidney injury (AKI) in order to improve the adverse health outcomes associated with this common condition. This project involves thorough evaluation of patient and provider feedback on barriers and facilitators to pediatric AKI self-management in order to develop patient-centered pediatric AKI interventions. This will be done through interviews with families of patients diagnosed with AKI and providers who take care of these patients followed by integration of the results into modification of an existing educational tool previously used in adult patients. The study will take place in three parts with the first involving interviews, the second involving tool modification and usability testing, and the third involving pilot testing of the tool's impact.

Eligibility Criteria:
Inclusion Criteria:

* age 1 to 18 years
* patients with diagnosis of AKI while hospitalized

Exclusion Criteria:

* legal blindness of deafness
* cognitive impairment that limits ability to consent
* non-English speaking
* patient age greater than age 18 years, 11 months
Alveolar Dead Space as Predictor of Organ Failure in Severe Sepsis

This is an observational study to understand the changes in alveolar dead space in medical critically ill patients with severe infection (severe sepsis) requiring mechanical ventilation and the possibility to predict multi-organ failure.

The measurement of alveolar dead space used to require sophisticated equipment and time. New ventilators have microprocessors that allow rapid mathematical calculation with minimal intervention.

The patient will be followed during their ICU stay up to two weeks while on mechanical ventilation.

Patient will be followed daily for the initial 48 hours and then once per week for 2 weeks while mechanically ventilated.

Eligibility Criteria:
Inclusion Criteria:

* Adults with severe sepsis or septic shock on mechanical ventilation
* Enrolled in the initial six hours of ICU admission

Exclusion Criteria:

* Patients with withdrawal or hospice order.
* Patients with terminal, irreversible disease, expect to decease in 48 hours from ICU admission.
* Patients with COPD.
* Patients transferred from outside ICU with ongoing sepsis management for more than six hours.
Compare the Quality of Life Between Patients With Conduit Diversions or Orthotopic Neobladders

The aim of this study is to compare the health-related quality of life (HRQoL) between patients underwent conduit diversion and orthotopic neobladder after radical cystectomy. The investigators plan to use validated HRQoL questionnaires to learn about how the different urinary diversion operations affect the HRQoL of people living with bladder cancer. The findings from this study may help doctors and patients choosing the proper operation type.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of muscle invasive bladder cancer
* Must be scheduled for radical cystectomy and subsequent conduit diversion or orthotopic neobladder
* Must be able to provide informed consent
* Must be 18 years of age or older
* May have had received intravesical neoadjuvant, adjuvant chemotherapy or immunotherapy

Exclusion Criteria:

* Follow-up data not obtained at Wuhan Union Hospital
FoodRx for Obesity Treatment

This study is a 3-group, parallel design, randomized controlled trial (RCT) in 105 adults with obesity and food insecurity that will compare BWL-Alone (including standard-of-care referral and connection with community food resources; n=35) to BWL plus food supplementation with either food vouchers (BWL+VOUCHER; n=35) or home-delivered, medically tailored groceries consistent with BWL recommendations (BWL+HOME; n=35). All groups will have BWL treatment provided for 24 weeks per clinical guidelines. Food vouchers and HOME will be provided for 24 weeks of treatment. Assessments will be conducted at baseline, and weeks 12 and 24.


Eligibility Criteria:
Inclusion Criteria:

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Age \>18 years
4. BMI \>30 kg/m2 at screening visit
5. Screening positive for food insecurity using a score of \>3 on the 10-item US Adult Food Security Survey Module109
6. Completion of baseline assessments
7. Ability to engage in physical activity (i.e., can walk at least 2 blocks)
8. Willing and able to provide pictures of food receipts to study team (or mail actual receipts)
9. Ability to reliably receive packages at a consistent location in a timely manner
10. Telephone or internet service to communicate with study staff
11. For females of reproductive potential: agreement to use of highly effective contraception for during study participation

Exclusion Criteria:

1. Serious medical conditions (e.g., type 1 or type 2 diabetes, renal failure) that may pose a risk to the participant during intervention, cause a change in weight, or limit ability to adhere to the program's behavioral recommendations
2. Significant psychiatric conditions (e.g., active substance abuse, schizophrenia) that may pose a risk to the participant during intervention, cause a change in weight, or limit ability to adhere to the program's behavioral recommendations
3. Breastfeeding, pregnant or planning pregnancy in the next 6 months
4. Planned move from the Philadelphia area in the next 6 months
5. Weight loss of \>5 kg in the previous 90 days
6. Recently began a course of or changed the dosage of medication that can cause significant weight change (±5 kg)
7. Previous or planned obesity treatment with surgery (excluding lap band if removed for \>1 year) or a weight-loss device
8. Use of prescription or over the counter medications for chronic weight management in the past 3 months
9. Household member already participating in study due to potential contamination effects
10. Lack of stable residence and ability to store and prepare food