cyrilzakka/clinical-trials huggingface dataset:
Cartilage Adaptation and Response to Interleukins and Exercise

This study will examine the effect of exercise on the turnover of collagen in articular cartilage and the content of cytokines in the synovial fluid from human adults with osteoarthritis.

By using stabile isotope labelling, this study will track the formation and destination of newly formed cartilage collagen in adult humans scheduled for knee replacement surgery due to osteoarthritis. The collagen formation as well as the effect on the cytokine content of the synovial fluid will be examined both at rest and in response to 4 weeks of exercise/training. Overall the project aims to improve the basic understanding of cartilage development and function in relation to osteoarthritis prevention.

Eligibility Criteria:
Inclusion Criteria:

* Primary osteoarthritis of the knee scheduled for knee replacement surgery
* Must be able to perform physical exercise
* Age 40-90 years old
* BMI 18.5-40 kg/m\^2
* None smoker for the last 6 weeks

Exclusion Criteria:

* Regular intake of:
* non steroid anti-inflammatory drugs (NSAID)
* corticoid-steroids
* disease modifying anti-rheumatic drugs (DMARD)
* cytostatic incl. chemotherapy
* immune suppressive medicine
* Inflammatory diseases or cancer
* Recent trauma to the knee (\< 3 months)
* Previous knee surgery
* Regular strenuous exercise ( \> 1 pr. month)
* Previous exposure to tracers (e.g. from another study)
Phase I/Ib Multiple Ascending Dose Study in China

The purpose of this study was to evaluate the maximum tolerated dose (MTD) and pharmacokinetics (PK) of Avelumab monotherapy in Chinese subjects.


Eligibility Criteria:
Inclusion Criteria:

* Signed written informed consent prior to any study-related procedures are undertaken that are not part of standard patient management
* Histologically or cytologically proven locally advanced unresectable or metastatic solid tumors, for which no standard therapy exists or standard therapy has failed
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at study entry
* Availability of a recently obtained formalin-fixed, paraffin-embedded block containing tumor tissue (biopsy from a non-irradiated area within 6 months) or 12 or more unstained tumor slides suitable for biomarker detection
* Other protocol defined inclusion criteria could apply

Exclusion Criteria:

* Prior therapy with any antibody/drug targeting T-cell coregulatory proteins (immune checkpoints) such as programmed death 1 (PD-1), PD-L1, cytotoxic T-lymphocyte antigen-4 (CTLA-4), 4-1BB, Lymphocyte-activation gene 3 (LAG-3), T-cell immunoglobulin and mucin-domain containing-3 (TIM-3) or anti-Cluster of Differentiation (CD)-127
* Persisting toxicity related to prior therapy (Grade greater than equals to \[\>=\] 2 National Cancer Institute- Common Terminology Criteria for Adverse Events \[NCI-CTCAE\] v4.03, except Grade less than \[\<\] 3 neuropathy and alopecia of any grade)
* Concurrent anticancer treatment (for example, cytoreductive therapy, radiotherapy \[with the exception of limited palliative bone-directed radiotherapy\], immune therapy, or cytokine therapy except for erthyropoietin).
* Concurrent immunosuppressive agents (except for corticosteroids at physiologic replacement dose, equivalent to less than equals to \[\<=\] 10 milligram \[mg\] prednisone daily)
* Severe hypersensitivity reactions to monoclonal antibodies (Grade \>= 3 NCI-CTCAE v4.03)
* Active brain metastases (except those treated locally, and have not been progressing for at least 2 weeks after the completion of therapy, with no steroid maintenance therapy required, and no ongoing neurological symptoms related to brain localization of the disease)
* Any history of anaphylaxis, or uncontrolled asthma (that is, 3 or more features of partially controlled asthma)
* Other protocol defined exclusion criteria could apply
HTX-011 in Spinal Surgery

This is a Phase 2, multicenter study in subjects undergoing an open lumbar decompression surgery.


Eligibility Criteria:
Inclusion Criteria:

* Is scheduled to undergo an open 1-3 level lumbar decompression surgery with or without fixation under general anesthesia.
* Females are eligible only if not pregnant, not lactating, not planning to become pregnant during the study.

Exclusion Criteria:

* Has a contraindication of a known or suspected history of hypersensitivity or clinically significant idiosyncratic reaction to required study medications.
* Has a history of severe allergic reaction due to aspirin or other NSAIDs, or known history of severe gastrointestinal adverse reactions associated with NSAID use.
* Has functioning intrathecal drug pump or spinal cord stimulator.
* Opioid use for most days within the last 3 months.
* Has initiated treatment with selective serotonin reuptake inhibitors (SSRIs), selective norepinephrine reuptake inhibitors (SNRIs), gabapentin, pregabalin, or duloxetine within 1 month prior to the scheduled surgery.
* Received an investigational product or device in a clinical trial within 30 days or within 5 elimination half-lives.
* Has a history of clinically significant cardiac abnormality, coronary artery bypass graft surgery within 12 months, or suspected coagulopathy or uncontrolled anticoagulation.
* Has impaired balance and is at risk of falling.
* Is currently undergoing treatment for hepatitis B, hepatitis C, or HIV.
* Has undergone 3 or more surgeries within 12 months.
* Has a known history of glucose-6-phosphate dehydrogenase deficiency.
* Has History of liver cirrhosis, having an aspartate aminotransferase \>3 × the upper limit of normal (ULN), or having an alanine aminotransferase \>3 × ULN.
Mindfulness Intervention to Improve Symptomology Among Cancer Survivors; Focus on Sleep and Stress Improvement

Mindfulness has been shown to help stress, fatigue, sleep complaints, and other symptoms but has not been extensively studied in cancer survivors. This study will enroll cancer survivors at the Greenville Health System Cancer Institute Center for Integrative Oncology and Survivorship to undergo the Mindfulness Based Cancer Survivorship (MBCS) four-week program, with assessments before, immediately after, and three months after the intervention. Results of the study will be used to develop new care models that improve cancer survivor stress and symptoms using mindfulness.

Cancer survivors suffer with stress, fatigue, sleep complaints, pain, and many other adverse health effects. Chronic stress is detrimental to quality of life and, potentially, length of survival among cancer survivors. Mindfulness-Based Cancer Survivorship (MBCS) is a four-week standardized mindfulness program, adapted for cancer survivors from Mindfulness-Based Stress Reduction (MBSR). MBCS teaches formal mindfulness practice (meditation) and informal mindfulness during daily activities. Mindfulness has been shown to help stress, fatigue, sleep complaints, and other symptoms but has not been extensively studied in cancer survivors. This study will enroll cancer survivors at the Greenville Health System Cancer Institute Center for Integrative Oncology and Survivorship to undergo the MBCS four-week mindfulness program, with assessments before, immediately after, and three months after the intervention. The assessments will include 1) questionnaires to measure lifestyle, stress, meditation habits, and sleep impairment, 2) blood tests to measure various biomarkers (e.g., inflammatory cytokines), 3) using a BodyMedia's Sensewear® armband for a week to measure sleep and physical activity, and 4) salivary cortisol levels. The forty participants will be randomized to either the intervention arm, the four-week MBCS mindfulness program, or the control arm, a brief control/breathing course. After the three month post assessment, participants in the control arm will have the opportunity to take the MBCS course. Results of the study will be used to develop new care models that improve cancer survivor stress and symptoms using mindfulness.

Eligibility Criteria:
Inclusion Criteria:

* Must be a cancer survivor
* Ability to read, write, and understand English
* Ability to participate in a group

Exclusion Criteria:

* Previous experience in a MBCS course
* Corticosteroid therapy greater than prednisone 25 mg per day or equivalent
Pretreatment With Valproate Prior to Immunotherapy Targeting Cluster of Differentiation Antigen 20 in Chronic Lymphocytic Leukemia

This trial includes patients with chronic lymphocytic leukemia, the most common kind of malignant lymphoma. Monoclonal antibodies directed against cluster of differentiation antigen 20 have improved treatment results in different forms of lymphomas; however in chronic lymphocytic leukemia treatment with monoclonal antibodies is less effective, and it has been suggested that this is depending on a lower expression of the cluster of differentiation antigen 20 protein on the chronic lymphocytic leukemia cells.

Valproate, an anticonvulsant drug, has been shown to increase the cluster of differentiation antigen 20 expression, and the rationale in this study is that an increasement of cluster of differentiation antigen 20 would make treatment with monoclonal antibodies in patients with chronic lymphocytic leukemia more effective.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-80 years
* Histologically confirmed chronic lymphocytic leukemia
* Leucocyte count more than 20 x 10 9/L
* No other simultaneous treatment for lymphoma
* No treatment indicated for chronic lymphocytic leukemia
* WHO performance status 0-2
* HIV negativity
* Negativity for hepatitis C virus , HBsAG, anti-hepatitis B core antigen, or other active infection uncontrolled by treatment
* Agree to abstain from donating blood while taking study drug therapy and for one week following discontinuation of study drug therapy
* Agree not to share study medication with another person and to return all unused study drug to the investigator
* Written informed concent

Exclusion Criteria:

* Psychiatric illness or condition which could interfere with the subjects' ability to understand the requirements of the study
* Neurological or neuropsychiatric disorder, interfering with the requirements of the study
* Hearing impairment over grade 2
* Porphyria
* History of acute or chronic hepatitis
* Family history of severe drug-induced hepatitis
* Pregnancy and lactation
Gastric Emptying Time of a Rice-based Meal

Adequate preoperative fasting is critical in preventing pulmonary aspiration of gastric content. Ultrasonography is considering as a useful test assessing the volume of gastric contents, but the emptying time of a rice-based meal (Asian foods) in healthy populations was not clear. The objective of this study was to investigate the minimum fasting time required for adequate gastric emptying after the ingestion of a rice-based meal.

Aspiration of gastric contents into the lungs in surgical patients is a rare, but serious adverse event. Because a proper preoperative fasting is mandatory before anesthesia to prevent this severe complication, patients undergoing elective surgery have traditionally asked to fast overnight to ensure that their stomachs are empty. However, it is difficult and uncomfortable for patients not to eat or drink, particularly for those scheduled for surgery later in the day. Fasting may lead to thirst, hunger, anxiety, and tiredness, along with the potential for hypoglycemia and dehydration. Moreover, prolonged preoperative starvation triggers a metabolic response that precipitates gluconeogenesis and increases the organic response to trauma \[7,8\] and leads to delayed recovery after surgery. Avoiding inordinate fasting before surgery markedly reduces postoperative insulin resistance which has beneficial effects on postoperative glucose and protein metabolism.

Current guidelines by the American Society of Anesthesiologists (ASA) recommend a minimum of 6 hours after a light meal (toast and clear fluid) and 8 hours if the meal includes fried or fatty foods. In the era of evidence-based medicine, however, these fasting recommendations to keep a patient in preoperative fasting of 6-8 hours after the intake of solid meal are derived from survey opinions solicited from 470 active members of the ASA membership despite insufficient literature.

Recent studies have shown that real-time ultrasonography can provide reliable information about the nature (clear fluid, solid, or none) and volume of gastric content, being a non-invasive, inexpensive and safe method. The ultrasonographic measurement of antral cross-sectional area (CSA) is used for the assessment of gastric emptying in diabetic or dyspeptic patients and clinical investigations in obstetrical anesthesia. Thus, we designed this study to evaluate scientifically the gastric emptying time of solid meal using serial sonographic assessment in healthy volunteers. (Especially, there was no study to evaluate the gastric emptying time of a rice-based meal.) The objective of this study was to confirm or confront the minimum fasting time required for adequate gastric emptying for a rice-based meal (Asian foods), according to the suggestion of current guideline.

Eligibility Criteria:
Inclusion Criteria:

* age over 18 years old
* body mass index between 18.5 and 29.9 kg/m2

Exclusion Criteria:

* history of gastrointestinal disease such as history of surgery of upper abdomen, hiatal hernia and gastroesophageal reflux,
* diabetes mellitus
* chronic kidney disease
* pregnancy
FLASH [Fluorescent Light Activated Synthetic Hypericin] Clinical Study: Topical SGX301 (Synthetic Hypericin) for the Treatment of Cutaneous T-Cell Lymphoma (Mycosis Fungoides)

To evaluate the use of SGX301, a topical photosensitizing agent, to treat patients with patch/plaque phase cutaneous T-cell lymphoma (mycosis fungoides).


Eligibility Criteria:
Inclusion Criteria:

* Subjects must have a clinical diagnosis of CTCL (mycosis fungoides), Stage IA, Stage IB, or Stage IIA.
* Subjects must have a minimum of three (3) evaluable, discrete lesions.
* Subjects must be willing to refrain from sunbathing for the duration of the study.

Exclusion Criteria:

* History of sun hypersensitivity and photosensitive dermatoses including porphyria, systemic lupus erythematosus, Sjögren's syndrome, xeroderma pigmentosum, polymorphous light eruptions or radiation therapy within 30 days of enrolling.
* Pregnancy or mothers who are breast feeding.
* Males and females not willing to use effective contraception.
* Unhealed sunburn.
* Subjects receiving topical steroids or other topical treatments for CTCL within 2 weeks.
* Subjects receiving systemic steroids, nitrogen mustard, psoralen UVA radiation therapy (PUVA), narrow band UVB light therapy (NB-UVB) or carmustine (BCNU) or other systemic therapies for CTCL within 3 weeks of enrollment.
* Subjects with significant history of systemic immunosuppression due to drugs or infection with HIV or HTLV 1.
* Subjects taking other investigational drugs or drugs of abuse within 30 days of entry into this study.
Efficacy of Acupuncture at Acupoints Group Around the Base of Skull for Post-Stroke Depression

The objective of this trial is to evaluate the efficacy and safety of electroacupuncture at acupoints group around the base of skull for post-stroke depression.

98 eligible participants with post-stroke depression will be recruited and randomly assigned to the experimental group and the control group in a ratio of 1:1. Participants in both groups will receive electroacupuncture or placebo acupuncture treatment at acupoints group around the base of skull 3 times a week for 4 weeks, and followed up for 24 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Conforming to the criteria for the diagnosis of PSD recommended by the "Chinese Expert Consensus on Clinical Practice of Post-Stroke Depression";
2. Aged 40 to 80 years old;
3. The score of HDRS-24 item scale is more than 8 points and less than 35 points, that is, mild to moderate depression;
4. Has not received antidepressant treatment or has been discontinued for more than 2 weeks before entering treatment, and has not participated in other ongoing clinical trials.

Exclusion Criteria:

1. Subjects with history of mental illness or family history of mental illness;
2. Subjects with severe heart, liver, kidney, hematopoietic system, endocrine and immune system diseases;
3. Subjects with dementia, aphasia, cognitive dysfunction or unable to cooperate with examination and treatment;
4. Subjects installed with the cardiac pacemaker;
5. Pregnant or lactating patients.
Remimazolam vs Desflurane for General Anesthesia for Ablation of Arrhythmia

In anesthesia for ablation for cardiac arrhythmias, abrupt hemodynamic changes or fatal arrhythmias can be seen frequently. Remimazolam is a novel ultra-short acting benzodiazepine that provides good hemodynamic stability compared to conventional anesthetic agents. This study aims to investigate whether remimazolam reduces vasoactive agent use during cryo/radiofrequancy ablation under general anesthesia, compared to desflurane(RCT).


Eligibility Criteria:
Inclusion Criteria:

* =or \> 20 years
* Admission for General anesthesia for RFCA or cryoablation procedure

Exclusion Criteria:

* No severe adverse effect history or hypersensitivity of benzodiazepines or its additives
* Acute alcoholic intoxication state
* Coma or shock state due to other condition than heart problem.
* Acute narrow-angle glaucoma
Functional MRI of Relaxation Response Training in Adults With Attention-Deficit/Hyperactivity Disorder

This research study is being done to examine how meditation and the relaxation response (RR) may change brain activity in attention-deficit/hyperactivity disorder (ADHD).


Eligibility Criteria:
Inclusion Criteria:

1. Male or female adults (ages 18 - 49).
2. Patients with the diagnosis of Attention Deficit Hyperactivity Disorder (ADHD), by the Diagnostic and Statistics Manual of Mental Disorders (DSM-IV), as manifested in clinical evaluation and confirmed by structured interview.

Exclusion Criteria:

1. Any current, non-ADHD Axis I psychiatric conditions
2. Baseline Beck Depression Inventory (BDI) \> 19.
3. Any clinically significant chronic medical condition.
4. Mental retardation
5. Organic brain disorders
6. Seizures or tics.
7. Pregnant or nursing females.
8. Clinically unstable psychiatric conditions (suicidal behaviors, psychosis).
9. Current or recent (within the past 2 years) substance abuse or dependence.
10. Patients currently or recently (within past 1 month) on psychotropic medication.
11. Subjects with current or prior adequate psychopharmacologic treatment for ADHD.
12. Regular practice of an Relaxation Response-inducing technique within the past year
13. History of claustrophobia or any of the standard contraindications to magnetic resonance imaging (MRI) scanning(metal objects within body).
Darbepoetin Alfa Administered Once Every 4 Weeks in the Treatment of Subjects With Anemia of Cancer

The purpose of this trial is to demonstrate benefit with respect to hematopoietic response in subjects with anemia of cancer randomized to Darbepoetin Alfa once every 4 weeks.


Eligibility Criteria:
Eligibility Criteria: - Subjects with non-myeloid malignancies - Subjects can not be on chemotherapy - Anemia of cancer - Eastern Cooperative Oncology Group (ECOG) status of 0 to 2 - Hemoglobin less than or equal to 11.0 g/dL - Adequate renal and liver function - Written informed consent
Hot and Cold Compress in Hemodialysis

Aims and objectives. To examine and compare the effects of hot and cold compresses administration on muscle cramps, fatigue, and comfort in hemodialysis (HD) patients.

Background. Muscle cramps and fatigue are common complications in HD patients and reduce patient comfort. Among the nursing interventions stated for the management of these complications in the literature, hot and cold therapy are remarkable. To the best of our knowledge, the present study is the first research up to date that examined and compared the effects of hot and cold compress administrations on abovementioned complications in HD.

Design. This placebo-controlled randomized trial was conducted in two hemodialysis centers between February and October 2020.

Methods. The study sample consisted of 69 patients, stratified and randomly allocated to two intervention groups and placebo group. For patients of each group, the implementation of the study continued for four weeks, 12 HD sessions.

Hemodialysis (HD) is a common renal replacement therapy used in the treatment of End-Stage Renal Disease (ESRD) worldwide. Although HD is a life-saving treatment for people with ESRD, it causes some acute and chronic complications. Muscle cramps and fatigue are two of the most common complications in HD, and these also cause reducing comfort. Management of complications in HD patients and ensuring an optimal comfort level are pivotal for nurses. According to the literature, recommended nursing practices for the management of cramps in HD patients include hot and cold therapy methods. Besides, preventing cramps can improve comfort by reducing fatigue. Therefore, this study aimed to examine and compare the effects of hot and cold compresses administration on muscle cramps, fatigue, and comfort in hemodialysis (HD) patients.

Eligibility Criteria:
Inclusion Criteria:

* between the ages of 18-65,
* receiving HD treatment for at least six months,
* three days a week with four-hour sessions
* with blood pressure 120/80 mmHg and higher at the beginning of the HD session,
* did not develop intradialytic hypotension in the first two hours of HD,
* hemoglobin value above 8.0 mg/dL,
* having a stable dry weight for the previous month (less than 2 kg change).

Exclusion Criteria:

* receiving intravenous electrolyte replacement during HD session,
* having a condition that prevented hot or cold administration such as diabetic neuropathy, burns, open wounds, and amputation in the lower extremities,
* with an oncological diagnosis or autoimmune disease (rheumatoid arthritis, systemic lupus erythematosus, ankylosing spondylitis, fibromyalgia, etc.),
* refused to participate in the study