cyrilzakka/clinical-trials huggingface dataset:
Does a Virtual Coach Offer a Better Solution for Weight Reduction in Ventral Hernia Patients With Obesity?

The purpose for this research is to create a MyChart-enabled virtual coach that assists obese patients lose weight prior to ventral hernia surgery. Researchers intend to show how the use of a virtual coach is more effective in preoperative weight reduction prior to ventral hernia repair over usual care. Correspondingly, this may lower unplanned hospital readmissions. For this clinical trial, where randomization is not possible, the study team will implement the use of propensity score matching that sorts individuals into different study arms as if randomly assigned. The primary outcome is the average net amount of time-dependent weight change per group over six months. Secondary outcomes are for the intervention group, patient satisfaction with the virtual coach and for both groups, quality of life. In addition, areas of social and economic disadvantage will be identified that may contribute to higher obesity rates. Machine learning (ML) modeling will be used to determine the important features for weight lost over the course of the study. The impact of this work will be to demonstrate efficacy and realized workflow efficiencies within a hospital-based surgery clinic.


Eligibility Criteria:
Inclusion Criteria:

* Subjects between 18 and 90 years of age with a Body Mass Index (BMI) of 30 and above and diagnosed with Obesity by the ICD 10 Code: E66.9 who have been evaluated by a surgeon and offered elective ventral hernia repair. Also, participants must have a complete medical record that allows for all statistical calculations to be performed.

Exclusion Criteria:

* Pregnant females, patients with severe mental disorders, prescribed psychiatric medications associated with weight gain, a history of a Substance Use Disorder, patients on long-term steroid therapy, and patients with insufficient medical records.
Extended Treatment in Metastatic Breast Cancer With Eribulin

Decision-making for treatment of metastatic breast cancer after the second line of chemotherapy was limited by the lack of established predictive factors of benefit for further chemotherapy regimens. Eribulin has emerged as the only single agent demonstrating an overall survival improvement in the third-line setting or beyond. The purpose of this study was to define the clinical profile of metastatic breast cancer participants achieving long-term benefit from chemotherapy with eribulin in the third-line setting or beyond.

This was a multicenter, retrospective, observational, case study analysis to assess long-term eribulin treatment in metastatic breast cancer. The study was conducted in 26 Spanish hospitals participating in a national pre-market access program to eribulin between 2011 and 2014. An exploratory comparison with a group of short-term responders included in a similar observational study was performed.

Eligibility Criteria:
Inclusion criteria:

* Participants with Advanced or Metastatic Breast Cancer on Eribulin for at least 7 months

Exclusion criteria:

* Lack of accessible clinical records
Platelet Rich Plasma on Osteoarthritis of Knee

Although few studies have showed beneficial effect of platelet rich plasma (PRP) for osteoarthritis of knee (OA knee), only one study applied randomized, control method and none of them has the objective measurements such as balance test or muscle strength which were reported as decrease in patients with OA knees. We assess the analgesic effect and the extent of improved muscle strength and balance after PRP in patients with OA knee.

Patients with bilateral OA knee will be enrolled and randomized into intervention and control knee. One dose of PRP is applied in the intervention knee and normal saline in control side. Outcome measurements included visual analog scale (VAS)、Lequesne's severity index、Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)、balance test (Biodex) and isokinetic strengthening test at different follow-up frame (2nd week, 1st month, 3rd month and 6th month after treatment).

Eligibility Criteria:
Inclusion Criteria:

1. Age between 35 to 75 y/o.
2. Alert consciousness
3. Symptom of knee osteoarthritis persist at least 6 months and stage I or II scored by Ahlbäck grading system
4. The pain score measured by VAS at least 4 points

Exclusion Criteria:

1. Has received hyaluronic acid or steroid injection within 6 monts
2. Has received NSAIDs or steroid within one week
3. Tumor or metastasis surrounding the knee joint
4. Has received total knee replacement, major surgery in knee, rheumatoid arthritis
5. Patient who cant tolerance the balance or muscle strength test.
Increasing Physical Activity in Ankylosing Spondylitis: a Randomised Controlled Trial

Ankylosing spondylitis is a chronic inflammatory condition that mostly affects the spine. This results in back pain and stiffness, and causes difficulty with daily activities. Physical activity and exercise are key components of the management of ankylosing spondylitis, however many adults with ankylosing spondylitis do not meet physical activity recommendations. This study aims to investigate the effects of a twelve week intervention designed to increase physical activity and exercise in adults with ankylosing spondylitis.

Participants will be randomly allocated to one of two groups. An intervention group will receive individual consultations with a physiotherapist. The aim of the meetings will be to motivate and support participants on an individual basis, with the goal of increasing weekly physical activity. The second group, the control group, will continue with their current management strategies. All participants will be assessed at baseline, post-intervention (after twelve weeks) and after a three month follow-up period. The primary outcome measure will be free-living physical activity over one week.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of ankylosing spondylitis (diagnosed by a rheumatologist).
* Able to read and understand the English language.
* On stable pharmacological management.

Exclusion Criteria:

* Under 18 years of age, or over 64 years of age
* Unable to read and understand the English language
* Concomitant cardiac, respiratory or neurological condition
* Co-morbidity restricting physical activity or inability to ambulate without a mobility aid
* Acute lower limb injury
* Uncontrolled epilepsy
* Cognitive difficulties limiting ability to follow safety and protocol instructions
* Pregnant
* Change in medication (type of dosage) within six weeks of testing
* On beta-blocker medication.
Outcomes in Bone Marrow Aplasia.

Bone marrow aplasia, also known as aplastic anemia (AA) is a potentially fatal bone marrow failure syndrome characterized by a paucity of hematopoietic stem cells (HSCs) and progenitor cells with varying degrees of cytopenia and fatty infiltration of the bone marrow space. Underlying mechanisms include immune-mediated attack, telomere defects, and inherent HSC compartment insufficiency. These events may occur individually or in concert, mostly involving effector T cells Historical treatment has included the use of high-dose chemotherapy and allogeneic stem cell transplantation as well as lymphotoxic immunosuppressive therapy (IST) Thrombopoietin (TPO) regulates platelet production, maturation, and release through binding of c-mpl on megakaryocytes.

Eltrombopag (E-PAG) is an oral synthetic small-molecule, noncompetitive, TPO agonist that initially was approved by the US Food and Drug Administration (FDA) for the treatment of chronic immune thrombocytopenic purpura. Single-agent activity of E-PAG was demonstrated in at least 1 lineage in 40 to 45% of patients with AA that was refractory to IST, leading to its approval by the FDA in this setting (5).

Eltrombopag evades cytokines blockade of c-MPL signaling and activates the c-MPL receptor by interacting with the transmembrane receptor domain, resulting in a conformational change without competing with TPO. Regarding AA, it is possible that eltrombopag promotes DNA repair in hematopoietic stem cells and progenitor cells. However, AA may appear to evolve to other hematologic diseases, most notably paroxysmal nocturnal hemoglobinuria and myelodysplastic syndrome, even to acute myeloid leukemia, and about 15% of patients evolve to myelodysplastic syndrome, acute myeloid leukemia or both after immunosuppressive therapy. Therefore, it is unclear but alarming that the use of eltrombopag exacerbates the clone evolution (6).

Eltrombopag and cyclosporin was active as front-line treatment of severe aplastic anaemia, with no unexpected safety concerns. This approach might be beneficial where horse-ATG is not available or not tolerated.

Eligibility Criteria:
Inclusion Criteria:

- Age \> 18. Newely diagnosed bone marrow aplasia Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. Patients started CSA plus Eltrombopag therapy Normal cardiac, hepatic \& renal functions

Exclusion Criteria:

Hypersensitivity or contraindications to eltrombopag. Cardiovascular, pulmonary, hepatic, or renal diseases. History of malignancy. Pregnant, breastfeeding. Inherited bone marrow aplasia. Secondry bone marrow aplasia Previous thromboembolic events. Previous malignancies either solid or hematologic.

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Behavioral Support Before Anesthesia

Studies shows that reduced nervousness before anaesthesia may improve a course past anaesthesia. Therefore it is interesting to investigate how we can best help patients shortly before anaesthesia. A RCT with three intervention arms (with different personal support) and a control arm (with usual personal support) is therefore performed.

Hypothesis: Nervousness is reduced by the new interventions compared to the usual help provided.

All patients receive behavioral support the last half hour before anaesthesia, but at different times and provided by persons with different connection to the patients.

The last two patients in all arms will be interviewed about their experiences with the help offered.

Statistic will provide results in the quantitative part of the study and analysis and interpretation following ideas of the French philosopher Poul Ricoeur will provide results in the qualitative part of the study.

Eligibility Criteria:
Inclusion Criteria:

* All Danish-speaking expected gynaecological cancer patients, who are offered open surgery at Odense University Hospital, who can speak for themselves and have the opportunity to have close relative to follow before anaesthesia and who accept participation.

Exclusion Criteria:

* Senility
Web-Based Survey of Pain, Stress and Complementary and Alternative Medicine

The investigators are inviting people with fibromyalgia, IBS, interstitial cystitis, chronic pain, and other chronic and recurring conditions to sign up and participate in a year-long Internet-based survey to study the effectiveness of alternative medicine and the interactions among stress and coping, pain, and treatment outcomes.

The survey is called PROCAIM, which stands for Patient-Reported Outcomes from Complementary, Alternative, and Integrative Medicine. PROCAIM was developed under a grant to UCLA researchers from the National Center for Complementary and Alternative Medicine.

This is a web-based study composed of surveys that will recur at intervals over 1 year!

TO ENROLL

* Log in to our web site: http://www.procaim.org/
* Register as a New User.
* Select clinic name: ClinicalTrials.gov.
* Read and sign the Consent Form.

After participants"sign" the form with their email address, participants can begin to answer the first in a series of questionnaires. The system will send participants email reminders at the time of each scheduled follow-up for one year.

For further information about PROCAIM, please contact:

* Deborah Ackerman, Ph.D.
* Department of Epidemiology
* UCLA School of Public Health
* Box 951772
* Los Angeles, CA 90095-1772
* deborah.ackerman@ucla.edu

PROCAIM, which stands for Patient-Reported Outcomes from Complementary, Alternative, and Integrative Medicine, was developed to collect and manage longitudinal patient data and implement patient-based outcomes assessment protocols at clinical sites around the country that offer various forms of CAM as well as clinics that provide the combination of conventional medicine with complementary and alternative therapies. PROCAIM is currently being used for a 12 month longitudinal survey to evaluate interactions among stress, symptoms, severity, and general well-being among people with fibromyalgia, IBS, chronic fatigue, and other chronic pain conditions, and the frequency and impact of co-morbid conditions among users of complementary and alternative medicines.

Eligibility Criteria:
Inclusion Criteria:

* Everyone who has a computer and is fluent in English will be eligible.

Exclusion Criteria:

* Only people with access to personal computers and the Internet and fluency in English will be able to participate. These exclusions are not based on age, gender, pregnancy, racial, or ethnic origin.
Potential Food Effect And Repeated Dosing of AX-024.HCl In Healthy Subjects

Part A: Food effect (a single oral dose of 500 mg AX-024.HCl under fasted and fed states) Eight (8) healthy male volunteers will receive a single dose of 500 mg AX-024.HCl in the fasted state (10 h overnight fast), and will return 2 weeks later to receive the same dose of AX-024.HCl following a meal.

Part B: Multiple doses (a once daily dose of AX-024.HCl or Placebo for 10 days).

Part B is a double-blind, dose escalating, placebo controlled, randomised, multiple dose study to assess the tolerability, safety and pharmacokinetics in 24 healthy male subjects. Subjects will be allocated to one of 2 dosing cohorts. Each cohort will have 12 subjects with 9 subjects randomised to receive AX-024.HCl and 3 subjects randomised to receive placebo.

There will be a data review following each dose level. Dose administration in the subsequent cohorts will only proceed after satisfactory data review on the blinded safety data and plasma PK data in the previous cohort.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with a body mass index (BMI) of 18 - 35 kg/m2, inclusive. BMI = Body weight (kg) / \[Height (m)\]2.
* Subjects must not be vegetarians or consume abnormal diets.
* Subject with no clinically significant abnormal serum biochemistry, haematology coagulation (Part B only) and urine examination values within 21 days of the first dose.
* Subject with a negative urinary drugs of abuse screen, determined within 21 days of the first dose (N.B. a positive alcohol result may be repeated at the discretion of the Investigator).
* Subject with negative human immunodeficiency virus (HIV) and hepatitis B surface antigen (Hep B) and hepatitis C virus antibody (Hep C) results.
* Subject with no clinically significant abnormalities in 12-lead electrocardiogram (ECG) determined within 21 days of the first dose.
* Subject with no history of autoimmune disease, cardiac disease, kidney disease or any food intolerance.
* Male subject willing to use 2 effective methods of contraception i.e. established method of contraception + condom, if applicable (unless anatomically sterile or where abstaining from sexual intercourse is in line with the preferred and usual lifestyle of the subject) from Day 1 until 3 months afterwards.
* Subjects must be available to complete the study (including follow-up visit).
* Subjects must satisfy a medical examiner about their fitness to participate in the study
* Subjects must provide written informed consent to participate in the study
Safety and Immunogenicity of EV71 Vaccine With or Without Aluminum Adjuvant in Infants

A randomized, double-blind, phase II-02 clinical trial is to evaluate the safety and immunogenicity of an inactivated EV71 vaccine with or without aluminum adjuvant


Eligibility Criteria:
Inclusion Criteria:

1. Healthy males and females, aged from 6 to 11 months old Health is determined by medical history, physical examination, laboratory examination and clinical judgment of the investigator
2. Provided legal identification for the sake of recruitment.
3. Subjects and/or parent(s)/legal guardian(s) are able to understand and sign informed consents.
4. Birth weight more than 2500 grams

Exclusion Criteria:

1. History of Hand-foot-mouth Disease
2. Subject that has allergic history of vaccine, or allergic to any ingredient of vaccine
3. Serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain
4. Congenital malformations or developmental disorders, genetic defects, or severe malnutrition
5. Epilepsy, seizures or convulsions history, or family history of mental illness
6. Autoimmune disease or immunodeficiency, or parents, brothers and sisters have autoimmune diseases or immunodeficiency
7. History of asthma, angioedema, diabetes or malignancy
8. History of thyroidectomy or thyroid disease that required medication within the past 12 months
9. Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws
10. Asplenia, functional asplenia or any condition resulting in the absence or removal the spleen
11. Acute illness or acute exacerbation of chronic disease within the past 7 days
12. Any history of immunosuppressive medications or cytotoxic medications or inhaled corticosteroids within the past six months (with the exception of corticosteroid nasal spray for allergic rhinitis or topical corticosteroids for an acute uncomplicated dermatitis)
13. History of any blood products within 3 months
14. Administration of any live attenuated vaccine within 28 days
15. Administration of subunit or inactivated vaccines ,e.g., pneumococcal vaccine, or allergy treatment within 14 days
16. Axillary temperature \> 37.0 centigrade before vaccination
17. Abnormal laboratory parameters before vaccination
18. Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent
Patient Controlled Methylphenidate for Cancer Related Fatigue: A Double Blind, Randomized, Placebo Controlled Trial

To determine the effectiveness of patient controlled methylphenidate as compared to placebo for the management of cancer related fatigue as determined by the Functional Assessment of Chronic Illness Therapy (FACIT)-F Fatigue score.

Primary objective:

-To determine the effectiveness of patient controlled methylphenidate as compared to placebo for the management of cancer related fatigue as determined by the Functional Assessment of Chronic Illness Therapy (FACIT)-F Fatigue score

Secondary objective

* To assess the efficacy of as needed methylphenidate on pain, sedation and quality of life.
* To assess the potential side effects of methylphenidate on appetite, insomnia and anxiety

Eligibility Criteria:
Inclusion Criteria:

* Presence of fatigue on a numerical scale during the last 24 hours of more or equal to 4 on a 0 to 10 scale in which 0 equals no fatigue and 10 worst possible fatigue.
* Patients should describe fatigue as being present for a minimum of four days.
* If patients are on opioids for the treatment of cancer pain, change of opioids is allowed.
* No clinical evidence of cognitive failure, with normal Mini Mental State Examination (MMSE). A score of 24 is considered as normal.
* Sign written informed consent.
* Patients must be 18 years or older.
* Patient willing to keep a daily diary, engage in daily telephone follow up with a nurse, and after 7 days of treatment patient will return for a follow up visit.
* Patient must have telephone access to be contacted daily by the research nurse.
* Hemoglobin of \>/=10 g/dl within 2 weeks of enrollment. If the patient has not had blood drawn for a hemoglobin level in the past two weeks, one will be done to determine the eligibility.

Exclusion Criteria:

* Major contraindication to methylphenidate i.e. hypersensitivity, anxiety, tension, agitation, or motor tics
* Currently on methylphenidate or has been on methylphenidate within the last 10 days.
* Inability to complete the baseline assessment forms or to understand the recommendations for participation in the study.
* Pregnant or lactating women.
* Patients taking MAO inhibitors, tricyclic antidepressants and clonidine.
* Patients with glaucoma, history of marked anxiety disorder, or history of substance abuse.
* CAGE questionnaire score for the last 2 years is 2 or above on a 0 to 4 scale
* History of Tourette's syndrome
* Patients with tachycardia and uncontrolled hypertension.
Stapled TransAnal Rectal Resection (STARR): Clinical and Radiological Outcome

To evaluate the correlation between clinical and radiological outcome after Stapled TransAnal Rectal Resection (STARR)


Eligibility Criteria:
Inclusion Criteria:

* \> 18 years
* clinical signs of ODS with prior not effective conservative treatment
* anterior rectoceles and/or intussusceptions in MR-defecography

Exclusion Criteria:

* \< 18 years
* fixed enteroceles
* severe fecal incontinence
* external rectal prolapse
* anismus