cyrilzakka/clinical-trials huggingface dataset:
The Early Rehabilitation Program in Post-LT Pts

The purpose of this study is to determine whether an early rehabilitation program for immediate liver transplant patients is safe and effective in preventing critical care illness and intensive care unit acquired weakness.

Patients with liver transplantation (LT) have poor general condition before surgery and require ICU care for a certain period. For those patients, the side effects of ICU care such as intensive care unit-acquired weakness (ICU-AW), critical illness polyneuropathy (CIP) are well known. Therefore, we access the safety and efficacy of early rehabilitation program (ERP) in liver transplant recipients.

Patients were retrospectively selected for the Pre-ERP group (2014.05-2014.10) and for the Post-ERP group (2015.10-2016.03). During the period of 6 months, 136 patients and 100 patients underwent LT, and 65, 62 patients were enrolled after exclusion. Forty patients from the each group were compared after propensity score matching (PSM).

Eligibility Criteria:
Inclusion Criteria:

* immediate post liver transplant patients

Exclusion Criteria:

* patients who transferred to sub-ICU within 72 hours re-liver transplantation case wound, mental problem post op bleeding unstable vital
New Diagnostic Tools in the Evaluation of the Posterior Compartment of the Women Pelvic Floor

The goal of this observational study is to evaluate the pressure and distensibility index of the anal sphincter complex using high-definition anorectal manometry and the Impedance Planimetry system in women with fecal incontinence or constipation, as well as in a group of healthy volunteer women. The main questions it aims to answer are:

Assess the diagnostic accuracy of the Impedance Planimetry system compared to high-definition anorectal manometry (HD-ARM) in patients with anal incontinence and obstructive defecation.

Evaluate the diagnostic accuracy of three-dimensional reconstruction of the anal sphincter complex using HD-ARM to identify anal sphincter complex lesions compared to pelvic floor ultrasonography.

Determine the impact on the quality of life in women with anal incontinence and obstructive defecation based on the severity of symptoms assessed by validated scales

Participants will undergo the following tasks:

Undergo high-definition anorectal manometry and Impedance Planimetry testing.

Undergo pelvic floor ultrasonography to assess structural and functional aspects

Complete validated scales to assess symptoms and quality of life related to anal incontinence and obstructive defecation.


Eligibility Criteria:
Inclusion Criteria:

* Anal incontinence group: Women over 18 years old with predominantly fecal incontinence symptoms (St Mark \> 6 points) and without constipation (KESS score \< 10 points)
* Obstructive defecation group: Women over 18 years old with constipation symptoms and obstructive defecation (KESS score ≥ 10 points) and without fecal incontinence symptoms (St Mark \< 1 point).
* Control group (healthy volunteers): Women over 18 years old without fecal incontinence (St Mark \< 1 point) or constipation (KESS score \< 10 points).

Exclusion Criteria:

* Anal incontinence and obstructive defecation groups: presence of anorectal tumors, ileo-anal/rectal anastomosis, previous anorectal surgeries (except primary repair of obstetric anal sphincter injury), anal stenosis, anal fistula, anal fissure, previous pelvic radiotherapy, use of opioids except loperamide, and history of inflammatory bowel disease (IBD).
* Control group (healthy volunteers): exclusion criteria are the same as for the patients groups and also include any volunteer with a history of systemic sclerosis, diabetes affecting target organs or insulin dependence, neurological conditions (stroke, multiple sclerosis, spinal cord injury, cauda equina syndrome, polyneuropathies), and history of pelvic floor disorder.
Palbociclib Plus Letrozole For Postmenopausal Women With HR(+) HER2(-) Advanced Breast Cancer For Whom Letrozole Is Deemed Appropriate

The purpose of this study is to provide access to palbociclib in Mexico and in selected Latin American countries before it becomes commercially available to patients with HR positive/HER2-negative ABC who are appropriate candidates for letrozole therapy.


Eligibility Criteria:
Inclusion Criteria:

* Adult women with proven diagnosis of advanced adenocarcinoma of the breast (locoregional recurrent or metastatic disease).
* Women who are not of childbearing potential.
* ER-positive and/or Progesterone receptor (PgR)-positive tumor based on local laboratory results (test as per local practice).
* HER2-negative breast cancer based on local laboratory results (test as per local practice or local guidelines).
* Patients must be appropriate candidates for letrozole therapy.
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
* Adequate bone marrow function.
* Adequate liver function
* Adequate renal function.

Exclusion Criteria:

* Known hypersensitivity to letrozole, or any of its excipients, or to any palbociclib excipients.
* Current use of food or drugs known to be potent inhibitors or inducers of CYP3A4 isoenzymes within 7 days prior to study entry.
* Prior treatment with any CDK inhibitor.
* Previous participation in a palbociclib clinical study.
* Participation in other studies involving investigational drug(s) within 2 weeks prior to study entry and/or during study participation.
* QTc \>480 msec; history of QT syndrome, Brugada syndrome or known history of QTc prolongation, or Torsade de Pointes.
* High cardiovascular risk, including, but not limited to recent myocardial infarction, severe/unstable angina and severe cardiac dysrhythmias in the past 6 months prior to enrollment.
* Diagnosis of any second invasive malignancy within the last 3 years prior to enrollment. Note: patients with adequately treated basal cell or squamous cell skin cancer, a history of intraepithelial neoplasia or in situ disease (eg, carcinoma in situ of the cervix or melanoma in situ) may enter.
* Active uncontrolled or symptomatic brain metastases. Previously treated and clinically stable, brain metastases are permitted.
* Other severe acute or chronic medical or psychiatric conditions.
* Patients who are investigational site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or patients who are Pfizer employees directly involved in the conduct of the study.
Safety and Tolerability of Varenicline in Schizophrenia (SATOVA)

This is a 15 week trial to determine (1) the safety and tolerability of varenicline when used for smoking cessation/reduction in individuals with schizophrenia; (2) if treatment with varenicline affects the symptoms of schizophrenia.

Researchers are looking to recruit a total of 50 subjects at Riverview and Forensic Psychiatric Hospitals who would like to reduce or quit smoking cigarettes. This open label pilot study will gather information regarding the safety and tolerability of varenicline in subjects who have been diagnosed with schizophrenia or schizoaffective disorder. Consenting subjects will be prescribed varenicline as follows: varenicline 0.5 mg/d for days 1 to 3, 0.5 mg twice daily for days 4 to 7, then 1 mg twice daily through week 12. The research team will meet with the subject once a week for twelve weeks and the subject will be interviewed and asked to complete questionnaires about his/her psychiatric symptoms, tobacco use and nicotine dependence. The measures used include the FTND, PANSS, CGI-I, CGI-S, ESRS, UKU, BARS, WSWS, QSU-brief, mCEQ, and the OAS-M. The CGI-SS will also be completed throughout the study as well as once weekly for three weeks following the completion of the study (Post-Study follow-up visits 1-3).

Eligibility Criteria:
Inclusion Criteria:

* Inpatients with a diagnosis of schizophrenia or schizoaffective disorder
* Individuals between the ages of 19 and 65 years of age
* Individuals that had smoked 10 cigarette/day or more during the previous year, and had no period of smoking abstinence longer than 3 months in the past year
* Individuals that are not expected to be discharged from hospital within 4 months.

Exclusion Criteria:

* Clinically significant allergic reactions to the study medication
* Clinically significant abnormalities in the screening laboratory values
* Subjects at significant risk of self-harm
* Previous treatment with varenicline
* Women who are pregnant, breast-feeding, or of child-bearing potential not using adequate contraception
* Men not using adequate contraception
* Use of medications that might interfere with the study medication evaluation

  * Nicotine replacement
  * Nortriptyline
  * Clonidine
The Dampness Syndrome of Chinese Medicine Cohort Study

The researchers plain to build a large-scale, longitudinal, prospective cohort characterized by TCM dampness syndrome. With the biobank of this cohort the investigators want to find the causality between TCM dampness syndrome and clinical chronic diseases and a new way to treat clinical disease.

DACOS is a national large- scale, longitudinal, multi-center, prospective, cohort study of natural person aged 35 to 75. The baseline survey and the follow-up surveys will be conducted in 5 areas covering the eastern, northern, western, southern and middle parts of China. In this study 100,000 natural person will be regularly followed up for 5 years(visited once a year), with the loss rate ≤15%. Three parts will be carried in the form of interview, physical examination and biological sample collection. During the interview, the investigators plan to do some questionnaires to learn participants' demographic characteristics, life style, disease history, healthy condition(EQ-5D-5L, SDS,), cognition state(AD-8, MMSE, MoCA) and the results of TCM syndrome differentiation(Score of Dampness syndrome and TCM constitution scale). All biological specimens (including blood, feces, urine, saliva and tongue coating) will be collected and stored in the biological resource center until researchers request their use. With the building up of this cohort, the researchers will analyze the causality between dampness syndrome and specific chronic diseases such as diabetes, coronary heart disease, cancer, dementia and so on.

Eligibility Criteria:
Inclusion Criteria:

1. Residents aged 30 to 79, whose residence is consistent with their registered permanent residence location;
2. Residents who voluntarily participate in the project, agree to the collection of their biological information, and sign the informed consent form;
3. Residents who have no mental illness and other related diseases, and display a normal ability of expression and understanding;

Exclusion Criteria:

1. Residents who reject collaboration;
2. Residents who allow no follow-up visits.
Offering Proactive Tobacco Treatment

This study uses a proactive outreach strategy, coupled with free nicotine replacement therapy (NRT) to increase the population impact of tobacco cessation treatment for diverse, low income smokers. Population impact is the product of treatment utilization (i.e., reach or exposure) and treatment efficacy (i.e., smoking abstinence rates among those who utilize treatment).

Participants will be randomized to receive either Usual (Reactive) Care or Proactive Outreach, Telephone Counseling and free nicotine replacement therapy (NRT).

Eligibility Criteria:
Inclusion Criteria:

* Must complete the baseline survey
* Current self-reported cigarette smoker
* Has a valid home address
* An adequate proficiency in English to complete study surveys and participate in telephone counseling.

exclusion Criteria:

* adult smokers not enrolled in the Minnesota Health Care Programs (MHCP).
To Evaluate the Introduction of a Public Health Approach to Peripheral Arterial Disease (PAD) Using National Centre for Sport and Exercise Medicine Facilities.

The aim of the project is to investigate the clinical and patient centred outcomes of people with Peripheral Arterial Disease (PAD) attending a podiatry led integrated care pathway, utilising advice on diet, activity and smoking cessation. The podiatry clinic will be delivered from the Move More centre (NCSEM) and participants will be encouraged to access these facilities as part of their activity programme which will be agreed with the physical activity team. Primary and secondary outcomes will be clinical - claudication pain, distance walked at 3 and 6 months, blood pressure and lipid monitoring, weight management, reduced BMI, and the success of any smoking cessation. Quality of life and patient satisfaction with the programme will also be assessed.


Eligibility Criteria:
Inclusion Criteria:

1. adult patient between the ages of 50-90 years,
2. Patient attending for podiatry treatment
3. diagnosis of PAD or is showing signs of symptoms of PAD
4. wishes to take part in the study.

Exclusion Criteria:

1. Anyone unable to give informed consent due to lack of mental capacity.
2. Anyone who would be unable to participate in increased activity due to other co-morbidities
Application of Autologous Adipose Stromal Vascular Fraction in the Treatment of Premature Ovarian Insufficiency

A single-center, prospective, randomised controlled clinical trial (1:1 treatment ratio), designed to investigate the efficacy and safety of autologous SVF in improving the pregnancy outcome of infertile patients with POI.

A single-center, large-scale, prospective, randomized controlled clinical trial will enroll 260 patients diagnosed with POI based on the inclusion and exclusion criteria from Peking University Third Hospital. Eligible participants will be randomized to two groups at a ratio of 1:1- SVF protocol, and conventional protocol.The participation in this study will be approximately 2 years with a total of 6 visits and 3 follow-up phone calls.

Eligibility Criteria:
Inclusion Criteria:

* Women aged ≥20 and ≤39 years who have childbearing requirements.
* Cessation of menstruation or oligomenorrhea for at least 4 months
* Serum level of basal follicle stimulating hormone (FSH) \>25 U/L at least 2 times (during the second to fourth day of the menstrual cycle or during amenorrhea; The interval between the two tests is 4 weeks)
* Serum level of Anti-Mullerian hormone (AMH) ≤1.1 ng/ml
* Women with intact uterus and bilateral adnexa.
* Voluntary participation and informed consent obtained.

Exclusion Criteria:

* Women with autoimmune diseases.
* Women with abnormal and uncontrolled thyroid function.
* Women with tumors in bilateral adnexa that are not clearly benign or malignant.
* Women with a history of malignant tumors, radiation therapy or chemotherapy.
* Women with a history of venous thrombosis or pulmonary embolism during the screening period.
* Women with severe illnesses that are not suitable for pregnancy, such as diseases of the circulatory system, urinary system, digestive system, endocrine system, respiratory system, immune system, mental or neurological system, etc.
* Women who continuously used systemic glucocorticoids or other immunosuppressants for≥3 weeks within 6 months before administration and women who used systemic glucocorticoids (prednisone≥20 mg/d or equivalent dose) or other immunosuppressants within 3 days before administration.
* Women who are allergic to the active ingredients or excipients of test drugs.
* Women with a family history of severe genetic diseases or gynecologic malignancies.
Study to Evaluate GlaxoSmithKline (GSK) Biologicals' MenC-TT Vaccine and Hib-MenC-TT Vaccine in Infants

The purpose of this primary vaccination study is to evaluate the immunogenicity, safety and reactogenicity of three doses of GSK Biologicals' MenC-TT (Neisseria meningitidis group C polysaccharide-tetanus toxoid) vaccine (2 different formulations) and of three doses of GSK Biologicals' Hib-MenC-TT (Haemophilus influenzae type b-MenC-TT) vaccine (2 different formulations) when given to infants in their 3rd, 4th, and 5th months of life. Concomitant vaccines were given to all children to complete the vaccination agenda.

Five parallel treatment groups receiving a 3-dose primary vaccination course: MenC-TT vaccine (2 formulations, double-blind) + Infanrix hexa® OR Hib-MenC-TT (2 formulations double-blind) + Infanrix penta® OR Meningitec™ + Infanrix hexa® (control). Three blood samples taken, before dose 1 and one month after dose 2 and dose 3.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female infants, 8 to 16 weeks of age at the time of the first vaccination.

Exclusion Criteria:

* Previous vaccination against OR history of OR exposure since birth to diphtheria, pertussis, tetanus, polio, hepatitis B, Hib and/or meningococcal disease.
* Planned administration/administration of a vaccine not foreseen in the study since birth.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
* A family history of congenital or hereditary immunodeficiency.
* History of any neurologic disorders or seizures, allergic disease or reactions likely to be exacerbated by any component of the vaccine
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of PF-06649751 in Subjects With Idiopathic Parkinson's Disease

This is a study with two sequential cohorts, each with three treatment periods. Single doses of PF-06649751 will be tested in this study, starting at a low dose and escalating to a dose projected to be under the current limits for drug concentration. Each cohort will aim to achieve approximately 9 completers. Primary endpoint is safety and tolerability, secondary endpoint is MDS-UPDRS part III.


Eligibility Criteria:
Inclusion Criteria:

* L-DOPA-responsiveness
* Hoehn \& Yahr Stage II-III inclusive
* Experiencing motor fluctuations
* Stable daily dose of L-DOPA of at least 300 mg
* Females on non-childbearing potential and male subjects

Exclusion Criteria:

* History of troublesome dyskinesias
* History of surgical intervention for Parkinson's disease
S9333A Study of Blood and Bone Marrow Samples From Patients With Previously Untreated Primary Acute Myeloid Leukemia

RATIONALE: Studying samples of blood and bone marrow from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research study is looking at blood and bone marrow samples from patients with previously untreated primary acute myeloid leukemia.

OBJECTIVES:

* Determine whether calmodulin-dependent protein kinase II-γ (CaMKIIγ) activation (autophosphorylation) is associated with specific clinicopathological variables and outcomes in blood and bone marrow samples from patients with previously untreated primary acute myeloid leukemia.

OUTLINE: Blood and bone marrow samples are analyzed by western blot using SDS-PAGE and immunoblotting using anti-calmodulin-dependent protein kinase II-γ (CaMKIIγ) and anti-phosphospecific (Thr286, 287) CaMKIIγ antibodies with signals detected via chemiluminescence. CaMKIIγ activation levels are linked to clinical variables within the SWOG database.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Cryopreserved specimens of marrow or peripheral blood from patients enrolled in clinical trial SWOG-9333 and meeting the following criteria:

  * Diagnosis of primary acute myeloid leukemia

    * No M3 disease
    * Previously untreated disease
  * Randomized to remission induction chemotherapy with mitoxantrone hydrochloride and etoposide (Arm II)

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Improving Walking Quality and Quantity in Osteoarthritis (IWALQQ-OA)

This study evaluates the feasibility of a mindful walking intervention for management of knee osteoarthritis. Participants will be randomly assigned to receive one of two interventions i.e. mindful walking intervention or a self-care intervention.

People with knee osteoarthritis have low levels of physical activity, especially walking activity. They also walk with abnormal walking biomechanics that are associated with greater knee loading. Therefore, it is important to increase the levels of walking activity in people with knee osteoarthritis, but also change their walking patterns to reduce knee loading.

This study will last 12 months and participants will be randomized into 2 groups. For the first 6-months, half of the participants will attend sessions at a community location that include training in mindful walking technique. The other half will meet for the same frequency and duration at a community location for education on osteoarthritis and its management (focusing on symptom management, importance of physical activity, weight management, etc.). Both groups will also receive a wrist-worn activity monitor and a smartphone application that they will use throughout the study. After 6-months all participants will be allowed to practice on their own.

All participants will complete gait analysis, knee MRI, questionnaires, physical function assessment at baseline and at 6-months. All participants will also complete questionnaires at 3,9, and 12 months. Weekly physical activity and knee pain data will be collected using the mobile health technology for 12- months.

Eligibility Criteria:
Inclusion Criteria:

* age 50-80 years
* BMI ≤40 kg/m2
* Meet American College of Rheumatology clinical and/or clinical+radiographic criteria for knee osteoarthritis
* Knee pain score ≥ 4 during last week
* Predominantly medial knee pain
* Predominantly medial knee radiographic osteoarthritis with or without radiographic patellofemoral osteoarthritis
* Ability to ambulate for a minimum of 20 minutes, without any assistive device
* Available for the study duration
* Own a smartphone
* Can speak and understand English

Exclusion Criteria:

* Contraindications to exercise
* Using orthotics for knee pain such as knee braces, wedge insoles
* Knee injection in previous 3-months
* Currently receiving physical therapy for knee pain
* Planning major treatment for knee pain (e.g., physical therapy, surgery) in next 6 months
* Self-reported joint diseases like rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, gout, etc.
* Self-reported total joint replacement in any lower extremity joint
* Self-reported neurological conditions like stroke, Parkinson's disease, etc.
* Self-reported muscular disease like muscle dystrophy
* Self-reported musculoskeletal or neurologic conditions that affect gait.