cyrilzakka/clinical-trials huggingface dataset:
A Study To Describe The Effect Of Impaired Hepatic Function Of The Pharmacokinetics Of Palbociclib

This is a phase 1 study to describe the plasma pharmacokinetics of a single oral 75mg dose of palbociclib administered to healthy volunteers, and subjects with mild, moderate, and severely impaired hepatic function.

This is a 4-cohort single period study. The four cohorts will consist of healthy volunteers, and subjects with mild, moderate, and severely impaired hepatic function. Each cohort will receive the same treatment consisting of a single oral 75mg dose of palbociclib administered with food. Serial PK samples will be drawn up to 120 hours post dose for the cohort consisting of healthy volunteers, and will continue until up to 192 hours post-dose for the cohorts of hepatic impairment subjects.

Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) of 18 to 40 kg/m2; and a total body weight \>50 kg (110 lbs)
* Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study
* Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures

Exclusion Criteria:

* Any condition possibly affecting drug absorption (eg, gastrectomy)
* A positive urine drug screen
* Pregnant female subjects; breastfeeding female subjects; female subjects of childbearing potential; male subjects with partners currently pregnant; male subjects of childbearing potential who are unwilling or unable to use a highly effective method of contraception for the duration of the study and for 90 days after the last dose of investigational product
* History of sensitivity to heparin or heparin-induced thrombocytopenia
* Blood donation of approximately 1 pint (500 mL) or more within 56 days prior to dosing
* Unwilling or unable to comply with the Lifestyle Guidelines described in this protocol
* Use of tobacco or nicotine products in excess of 5 cigarettes per day (or equivalent)
* History of sensitivity to palbociclib
Effects of Aerobic Exercise on Lean Non-alcoholic Fatty Liver Disease (NAFLD)

NAFLD is increasingly being identified in lean individuals, especially in Chinese population. Among the NAFLD patients, the lean NAFLD accounts for 15.9%-23.0%. Previous studies showed that the lean NAFLD individuals might have a higher risk of severe hepatic disease than those obese individuals. However, the effects of aerobic exercise on the reduction of liver fat content and metabolic risk factors in lean NAFLD individuals remain unknown. In this randomized controlled trial, we will examine the effect of a 3-month exercise training (aerobic exercise) on liver fat content and metabolic risk factors in lean NAFLD individuals.

The whole study is divided into four phases: recruitment phase, training phase (1 month, aim to gradually adapt patients to the target exercise intensity), implementation phase (3 months), and follow-up phase (9 months). And the subjects are randomly assigned to two groups: aerobic exercise intervention group and control group.

Eligibility Criteria:
Inclusion Criteria:

* 1. Subjects with NAFLD determined by MRI-PDFF (liver fat\&amp;gt;5%).

  2. Subjects with BMI\&amp;lt;23 kg/m2.

  3. Subjects with inactive exercise before.

  4. Subjects with basic abilities of understanding, communication and writing.

Exclusion Criteria:

* 1. Regular drinkers (consumed more than an average of 140 grams of ethanol per week in men and 70 grams in women during the past twelve months).

  2. Complicated with other liver diseases (i.e. acute or chronic viral hepatitis, liver cancer, liver cirrhosis, drug-induced liver diseases, and autoimmune hepatitis).

  3. Subjects with abnormal liver function (i.e. more than 3 times the upper limit of normal alanine aminotransferase and aspartate aminotransferase).

  4. Complicated with severe cardiovascular disease \[i.e. myocardial infarction, arrhythmia, heart failure (New York Heart Association III or IV), uncontrolled hypertension (i.e. systolic blood pressure \&amp;gt;180 mmHg, and/or diastolic blood pressure \&amp;gt;100 mmHg)\].

  5. Complicated with severe kidney disease or severe renal insufficiency or tumour.

  6. Currently pregnant or planning to be pregnant or breast feeding women.

  7. Participating in weight loss programs/exercise programs currently or during the past three months.

  8. Having any medical condition that would affect metabolism or limit exercise (i.e. diabetes, known hyperthyroidism or hypothyroidism).

  9. Having a medical condition that would limit exercise participation or alter heart rate during exercise or taking medication that would affect metabolism or weight loss (i.e. glucocorticoids, antithyroid drugs, hypoglycemic drugs, antihypertensive drugs).

  10. Having been doing regular physical exercise for the past three months (i.e. 3 times/week, \&amp;gt;30 min/time).

  11. Subjects with poor adherence.
Frailty Assessment and Treatment Strategies in the Elderly at Risk of Functional Decline in the Community

This study aims to design a patient -centered program to prevent or delay frailty , functional decline and adverse events, and evaluates the effectiveness of the program with a randomized clinical trial.

Objective: To design and evaluate the implementation and impact of a multimodal intervention focused on elderly patients living in the community in preventing or delaying frailty, functional decline and risk of institutionalization, hospitalization and death.

Design: Study in two phases: a qualitative study to develop the intervention and a randomized clinical trial with parallel arms and control group.

Intervention: Participants in the control group will receive the usual standard care and regular referrals. Patients in the intervention group will be first derived to a nurse case manager for initial application of a comprehensive geriatric assessment (CGA). Then patient-centered interventions will be prescribed, according to the different target areas identified in the geriatric assessment, along with medication review, aerobics exercise plan and memory workshops following the model adapted in Phase I.

After 3 and 18 months, measures of functional and cognitive performance, quality of life, frailty, adverse outcomes (institutionalization, hospitalization, death) and health care costs will be collected.

Eligibility Criteria:
Inclusion Criteria:

* Positive screen in the accumulation of deficits electronic frailty index
* Positive screen with Gerontopole screening tool and/or RISC tool

Exclusion Criteria:

* Living in an institution
* Advanced conditions with short life expectancy
* Severe disability
* Severe Dementia
Preliminary Study of Safety and Efficacy of Nanocrystalline Silver Cream in Atopic Dermatitis (Eczema)

Nanocrystalline silver (very small particles of silver) is the active ingredient in Acticoat dressings, which have been approved for the treatment of burns and other wounds. Silver has been used for decades as an effective antimicrobial agent. In animal studies, nanocrystalline silver cream (NPI) has also demonstrated anti-inflammatory activity. Thus, nanocrystalline silver cream is being evaluated in the treatment of inflammatory skin conditions such as atopic dermatitis (eczema).

Approximately 180 study subjects with a definitive diagnosis of mild to moderate eczema will be enrolled in this study. Subjects will be randomly assigned to treatment with placebo, 0.5% NPI or 1% NPI for the 6-week treatment period. Assessments of treatment effect and safety will be performed weekly. Upon completion of the study, subjects may be eligible for 12 weeks of open-label treatment with 1% NPI.


Eligibility Criteria:
* Male or female, any race, 18 to 65 years of age.
* Females must be post-menopausal, surgically sterile, or if of child-bearing potential, not pregnant (confirmed by test) and using an adequate method of birth control.
* Subjects must have eczema that covers a minimum of 5% total body surface area.
* Subjects must agree not to use other eczema medications for the 6-week study treatment period.
* Subjects must not be enrolled in another investigational drug study.
* Subjects must not be allergic to silver or cocoa butter.
Surround Inhibition in Patients With Dystonia

This study will use transcranial magnetic stimulation (TMS) to examine how the brain controls muscle movement in dystonia. Dystonia is a movement disorder in which involuntary muscle contractions cause uncontrolled twisting and repetitive movement or abnormal postures. Dystonia may be focal, involving just one region of the body, such as the hand, neck or face. Focal dystonia usually begins in adulthood. Generalized dystonia, on the other hand, generally begins in childhood or adolescence. Symptoms begin in one area and then become more widespread.

Healthy normal volunteers and patients with focal \[or generalized\] dystonia \[between 21 and 65 years of age\] may be eligible for this study.

Participants will have transcranial magnetic stimulation. For this test, subjects are seated in a comfortable chair, with their hands placed on a pillow on their lap. An insulated wire coil is placed on the scalp. A brief electrical current is passed through the coil, creating a magnetic pulse that stimulates the brain. (This may cause muscle, hand or arm twitching if the coil is near the part of the brain that controls movement, or it may induce twitches or transient tingling in the forearm, head or face muscles.) During the stimulation, subjects will be asked to either keep their hand relaxed or move a certain part of the hand in response to a loud beep or visual cue. Metal electrodes will be taped to the skin over the muscle for computer recording of the electrical activity of the hand and arm muscles activated by the stimulation.

There are three parts to the study, each lasting 2-3 hours and each performed on a separate day.

The purpose of this study is to evaluate modulation of inhibition within the motor cortex before and during movement in patients with focal dystonia. For a selective movement or task, certain muscles are normally recruited and others are inhibited at the cortical level. We hypothesize that a disturbance in this cortical inhibitory control could result in a failure to focus the desired motor action within the motor cortex (disturbed center surround inhibition) and may account for co-contraction of antagonist muscles and overflow into extraneous muscles in dystonic patients. Intracortical inhibition (ICI) and silent period (SP) are two major cortical inhibitory mechanisms demonstrated by transcranial magnetic stimulation (TMS). Alteration in these inhibitory mechanisms have been studied in dystonia at rest, however, as dystonic symptoms mainly occur with selective tasks or movements we plan to study intracortical inhibitory mechanisms before and during movement using different TMS paradigms.

Eligibility Criteria:
Healthy volunteers entering the study must be free of serious somatic disease.

Patients must have focal dystonia.

Subjects who have a pacemaker, an implanted medication pump, a metal plate in the skull, metal objects inside the eye or skull (for example, after brain surgery or a shrapnel wound) or any recent (less than 3 months) brain lesions, will be excluded.
Effects of Two Sub-occipital Techniques on Limited Mobility According to the Flexion-rotation Test

The cervical spine should work as a functional unit. If hypomobility should exist in any of the segments it would limit the mobility of the spine as a whole. Although it is frequent that certain cervical segments present hypomobility, they are not always related to symptomatology. The effects of inhibition sub-occipital techniques on cervical mobility have not been evaluated.

The objetive of this trials is to assess and compare the effects on cervical mobility, of the manual technique of sub-occipital inhibition by applying pressure and self-treatment by way of Occipivot® cushion, in subjects with no cervical symptomatology but with limited mobility assessed by the flexion-rotation test.


Eligibility Criteria:
Inclusion Criteria:

* Flexion rotation test with less than 32º or asymmetry of 10º between right and left, whenever one of the sides does not exceed physiological C1-C2 ROM (45º)
* Sing the informed consent form.

Exclusion Criteria:

* Inability to tolerate FRT
* Contraindication to manual therapy.
* Cervical treatment during the study.
* Poor language and communication skills making difficult to undertand the informed consent.
Sedation of Advanced Endoscopic Procedure

To evaluate the impacts of target-control infusion (TCI) and bispectral index (BIS) monitoring during advanced endoscopic procedure.

Anesthesia requirements for advanced endoscopic procedures are approaching those of specialized surgical interventions. Although many other sedative agents are used prior to and during endoscopy, none approach propofol in terms of desirable properties. The risk of propofol sedation for interventional procedures such as endoscopic retrograde cholangiopancreatography (ERCP), endoscopic ultrasound (EUS), and therapeutic endoscopy are among the highest for any sedated endoscopic procedure. The reasons are many: the intensity of stimulation encountered during these procedures is similar to many minor surgeries; the airway management is complex and requires constant attention; the incidence of hypoxemia is high, and the time available for recognition and management is limited. In order to reap the benefits of advanced endoscopic procedures, anesthesiologists must rise to the challenge. This requires a dedicated anesthetic team practicing safe, efficient, and effective sedation techniques for advanced endoscopic procedures. Ongoing research into novel infusion methods can add safety to the existing sedation techniques and address some of the concerns related to sedative quality. This is a randomized controlled and prospective study. To evaluate the benefits when we use target-controlled infusion of propofol (TCI) with/without bispectral index monitoring in patients undergoing advanced endoscopic procedure. The primary outcome is the total amount of propofol. The secondary outcomes are patients' and endoscopists' satisfaction, sedative-related adverse events, recovery time.

Eligibility Criteria:
Inclusion Criteria:

* patients undergo advanced endoscopic procedure

Exclusion Criteria:

* age less than 20 years, pregnant and lactating women, American Society of Anesthesiologists (ASA) class V, allergy to propofol, benzodiazepine, or opioid, and a requirement for general anesthesia
Preliminary Study of the Sagittal Alignment of the Lumbo-pelvic Complex in a Sitting Position

The main objective of this study is to investigate the influence of seat type (straight chair versus "ergonomic" chair) on the sagittal alignment of the lumbo-pelvic complex in two different postures compared to standing for each individual in both a chronic-back-pain and a non-chronic-back-pain population.


Eligibility Criteria:
General Inclusion Criteria:

* The patient must have given his/her informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan

Inclusion Criteria for the Chronic Back Pain Group

* Patient has chronic lombalgia (\> 3 months)
* Patient has discopathy evidenced by standard imaging of the lumbar spine

Inclusion Criteria for the Non Chronic Back Pain Group

* Patient does not have chronic lombalgia or neurological symptoms
* Patients hospitalized for cardiovascular physical therapy which does not interfere with the sagital alignment of the lombo-pelivien complex (post-infarctus care, cardiac insufficiency)

Exclusion Criteria:

* The patient is participating in another study
* The patient is in an exclusion period determined by a previous study
* The patient is under judicial protection, under tutorship or curatorship
* The patient refuses to sign the consent
* It is impossible to correctly inform the patient
* The subject has had more than two x-rays, or similar ray exposure during the previous year
* The subject has a professional activity or hobby that exposes him/her to radiation
* The subject has a lombo-pelivien malformation
COVID-19 in Cancer Patients: Evaluation of Clinical Course and Impact on Oncological Care Including Biobanking

The COVIDHELP study will prospectively evaluate the yet unknown clinical course of the COVID-19 infection in cancer patients and document the impact of potential infrastructural limitations on cancer care of COVID-19 positive patients. All patients consenting will provide peripheral blood samples for prospective biobanking with the aim of investigating immune response and immunity against COVID-19.

Based on patients, who are treated in the University Cancer Center Hamburg (UCCH) and its contracted partner network, which comprises all cancer treating departments at the University Medical Center of Hamburg-Eppendorf (UKE), as well as 19 office-based oncologists and 20 surrounding hospitals, recruitment for the study will be done as follows:

(i) as a cancer patient during regular aftercare appointments who reports a current or past COVID-19 infection.

(ii) as an acute COVID-19 patient who reports a prevalent cancer diagnosis

Data will be collected as available from routine clinical care and includes demographic and biometric data, medical history, baseline data at inclusion as well as inpatient and intensive care unit admissions. Upon consent, patients will provide peripheral blood samples at time of inclusion and after 6 month. Recruitment is limited to a one-year period (April 2020 - April 2021).

Eligibility Criteria:
Key inclusion criteria:

* Known diagnosis of cancer
* Known diagnosis of CoVID-19 infection
* Age ≥ 18 years
* Signed informed consent

Key exclusion criteria:

• refusal of participation
Efficacy and Safety Study of ALS-L1023 in Patients With Abdominal Obesity of Metabolic Syndrome

The main objective of this study is to evaluate efficacy and safety of ALS-L1023 tablet in patients with abdominal obesity of metabolic syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Aged between 20 and 64 years(Both genders)
* more than 2 among components of the metabolic syndrome

  * Triglyceride \>= 150mg/dL
  * HDL-D: Women \< 50mg/dL or Men \< 40mg/dL
  * Hypertension: Systolic blood pressure \>= 130mmHg or Diastolic blood pressure \>= 85mmHg
  * Hyperglycemia: fasting plasma glucose \>= 100 mg/dL
* Informed consent awarding

Exclusion Criteria:

* Alcohol or any drug abuse
* Any investigational medication during the preceding 3 months
Bicalutamide and Goserelin in Treating Patients With Cancer of the Ovary, Fallopian Tube, or Peritoneum

RATIONALE: Some tumors need growth factors produced by the body's white blood cells to keep growing. Goserelin may interfere with the growth factor and may stop the tumor from growing. Bicalutamide may prevent androgens from stimulating the growth of cancer cells.

PURPOSE: Phase II trial to study the effectiveness of goserelin plus bicalutamide in treating patients who have refractory or recurrent cancer of the ovary, fallopian tube, or peritoneum.

OBJECTIVES: I. Determine the time-to-treatment failure in patients with ovarian epithelial, fallopian tube, or peritoneal carcinoma, in second or greater remission, treated with bicalutamide and goserelin. II. Assess luteinizing hormone and follicle-stimulating hormone suppression in correlation with serum vascular endothelial growth factor levels, and determine if these levels are related to time to treatment failure in these patients. III. Correlate the presence or absence of androgen receptor tissue expression by immunohistochemistry and androgen receptor gene trinucleotide repeat length to time to treatment failure in these patients.

OUTLINE: Patients receive oral bicalutamide once daily and goserelin subcutaneously once every 4 weeks. Treatment continues in the absence of unacceptable toxicity until disease recurrence.

PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed epithelial carcinoma arising in the ovary, fallopian tube, or peritoneum, in second or greater remission Failed initial therapy with persistent or recurrent disease Cytoreductive surgery AND At least 1 platinum-based chemotherapy regimen No evidence of disease within 4 months of salvage chemotherapy CA-125 less than 35 U Negative physical exam No abdominal or pelvic disease by CT

PATIENT CHARACTERISTICS: Age: Adult Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 2 times upper limit of normal (ULN) SGOT less than 2 times ULN Alkaline phosphatase less than 2 times ULN Renal: Not specified Other: No other active invasive malignancy No inability to receive subcutaneous injection No inability to tolerate oral medication

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: See Disease Characteristics Other: No concurrent oral anticoagulants
Characterization of Human Autoantibody Titers After Central Nervous System Insult

The aim of the study is to quantitate Central Nervous System (CNS) autoantibody development in human blood using ELISA after human brain injury, spinal cord injury, and intra-axial brain surgeries.

Study Objectives:

We aim to:

1. Quantitate CNS autoantibody development in human blood using ELISA after human brain injury, spinal cord injury, and intra-axial brain surgeries. We also aim to characterize the temporal course of this response.
2. Characterize how CNS autoantibody levels correlate with specific injury patterns as well as radiographic and clinical measures of injury severity.
3. Determine how intercurrent infection and a history of prior CNS insult affects the temporal course and magnitude of autoantibody production.

Eligibility Criteria:
Inclusion Criteria:

* Have a severe traumatic brain injury
* Have spinal cord injury ASIA grade A, B or C
* Undergoing resection of intra-axial brain tumors

Exclusion Criteria:

* Participant who is pregnant
Analgesic Treatment for Cancer Pain in South East Asia

This study is planned to investigate the pain control status in cancer patients in 6 South East Asian countries through evaluation of prescription pattern of analgesics, satisfaction of pain control, quality of life and assessment of the adequacy of pain control and relationship among these factors in cancer patients with pain. Cancer pain is undermanaged and it is hoped that this study will be used as a reference for effective cancer pain management in these countries.


Eligibility Criteria:
Inclusion Criteria:

1. Adult (over 18 years) cancer patients \[country variation would be accepted based on the definition of adults\]
2. Cancer has been diagnosed pathologically
3. Out-patients with cancer pain due to cancer itself or its treatment
4. Patients being treated with any analgesics for more than one month for the management of cancer pain at enrolment
5. Patients who are willing to voluntarily sign the study consent form

Exclusion Criteria:

1. Patients who have had an operation for any reasons within 3 months prior to the enrolment
2. Patients with any oncologic emergency
3. Patients who had any interventional therapy (e.g. nerve block, neurolytic procedures) related to their cancer pain within 6 weeks of study entry
4. Insufficient ability or willingness to cooperate
5. Patients who are judged not suitable to participate in this study by the investigator
6. Patients who are participating in any other interventional clinical trials for cancer treatment or supportive care