cyrilzakka/clinical-trials huggingface dataset:
Combination of Venetoclax, Hypomethylation Agent and Low-dose Cytarabine as a Salvage Therapy for Acute Myeloid Leukemia

Although studies are ongoing to evaluate the efficiency and safety of venetoclax-based therapy, alone or in combination with hypomethylation agent or low-dose cytarabine, in relapsed/refractory acute myeloid leukemia, data are scarce and heterogenous. In this study, the investigators aimed to assess safety and response to a new venetoclax-based triple-drug combination regimen (venetoclax + hypomethylation agent + low-dose cytarabine) in acute myeloid leukemia patients who had relapsed/refractory disease or positive minimal residual disease.

Although the promising activity of venetoclax-based therapy is well demonstrated in the treatment of previously untreated elderly or unfit patients with acute myeloid leukemia, there are few data on the efficacy of venetoclax-based salvage therapy in relapsed/refractory patients, which can be difficult to treat. To date, data on venetoclax as monotherapy or in combination with hypomethylation agent or low-dose cytarabine as a salvage regimen in relapsed/refractory AML are scarce and heterogenous. In this study, the investigators aimed to assess safety and efficiency of a new triple-drug combination regimen, venetoclax + hypomethylation agent + low-dose cytarabine, in patients with relapsed/refractory acute myeloid leukemia or persistent positive minimal residual disease in the salvage setting.

Eligibility Criteria:
Inclusion Criteria:

1. Aged ≥18 years old, voluntarily participate in clinical research and sign an informed consent form and be willing to follow and be able to complete all experimental procedures.
2. The toxic and side effects caused by the last treatment should be recovered.
3. Eastern Cooperative Oncology Group score of 0 to 3 points.
4. The organ function is intact.

   * Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) ≤2.5×ULN (Upper Limit of Normal).
   * Creatinine≤1.5×ULN.
   * Bilirubin≤1.5×ULN.
5. Karnofsky≥70.
6. The expected survival period is at least 12 weeks.
7. Non-pregnant, non-breastfeeding women.

Exclusion Criteria:

1. Suffering from other untreated or unrelieved malignant tumors within 2 years.
2. Major surgery, radiotherapy, chemotherapy, biological therapy, immunotherapy, and experimental therapy were performed within 2 weeks of the first medication.
3. Suffering from any other known serious and/or uncontrolled disease (eg, uncontrolled diabetes; cardiovascular disease, including congestive heart failure New York Heart Association \[NYHA\] Class III or IV, 6 months patients with myocardial infarction and poorly controlled blood pressure); chronic renal failure; or active uncontrolled infection); the investigators considered unsuitable for this clinical trial.
4. Patients who are unwilling or unable to comply with the protocol.
5. Currently being treated with other systemic anti-tumor or anti-tumor research drugs.
6. Women who are pregnant or breastfeeding.
Biomarkers in Post-Menopausal Women Receiving Flaxseed

This randomized clinical trial studies biomarkers in post-menopausal women receiving flaxseed. Studying samples of blood, urine, and feces in the laboratory from participants receiving flaxseed may help doctors understand the effects of flaxseed on biomarkers.

PRIMARY OBJECTIVES:

I. To determine associations between the composition of the gut bacterial communities and baseline levels of the mammalian lignans and steroid hormones.

II. To determine how variation in gut microbial community composition and in steroid hormone and xenobiotic metabolizing genes affects the metabolism of mammalian lignans and steroid hormones after exposure to a lignan-rich food (flaxseed).

III. To determine how these associations differ by race (i.e., African American and European American women).

OUTLINE: Participants are randomized to 1 of 2 treatment groups.

GROUP I: Participants receive flaxseed orally (PO) daily for 6 weeks. After a usual diet "washout" period of 8 weeks, patients crossover to Group II.

GROUP II: Participants maintain a usual diet for 6 weeks. After a usual diet "washout" period of 8 weeks, patients crossover to Group I.

After completion of study treatment, participants are followed up for 30 days.

Eligibility Criteria:
Inclusion Criteria:

* Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
* Participant must be a non-Hispanic white or non-Hispanic black (self-reported race) woman 45 to 80 years of age and postmenopausal; postmenopausal will be defined as no menstrual cycle in the past 12 months; women with a hysterectomy but with intact ovaries will be included if aged \>= 55 years
* Willingness to comply with the requirements of the study

Exclusion Criteria:

* Unwilling or unable to follow protocol requirements
* Self-reported race other than non-Hispanic white or non-Hispanic black
* Use, in the 2 months prior to week 1 visit, of antibiotics, hormone replacement therapy, nonprescription hormones or herbal supplements for menopausal symptoms, or flaxseed supplements
* Nut or seed allergy
* Self-reported inflammatory bowel disease
* Gastric bypass
* Use of thyroid replacement medication (Synthroid or similar) for \< 1 year
* Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive flaxseed
* Chemotherapy/radiation within the past year
* Body weight greater than 400 pounds (limit of Tanita scale)
The Effect of Acute and Chronic Exercise at the Metabolic Syndrome and Markers of Inflammation in Obese Subjects

The human adipose and muscle -tissue produce and release a number of bioactive proteins which contributes to the chronic low grade of inflammatory status which is associated with obesity and plays an important role in the pathogenesis of type 2 diabetes and cardiovascular diseases.

Study 1: Our aim is to investigate if exercise has independent and additive effects in combination with diet-induced weight loss on circulating levels of inflammatory markers and mRNA levels in subcutaneous adipose tissue (SAT) and skeletal muscle tissue (SM.

Study 2: Our aim is to investigate whether gender and weight status plays a role in the metabolic response during two hours of acute exercise


Eligibility Criteria:
Inclusion Criteria:

* Age 18-45 years,
* obese (30 kg/m2 \< BMI \< 40 kg/m2) physically inactive (\<30 minutes pr. day)
* and weight stabile for at least three months (± 2 kg of current body weight)

Exclusion Criteria:

* cardiovascular disease,
* type 2 diabetes, pregnancy or orthopaedic difficulties causing inability to undertake an exercise program
Effectiveness of a Cognitive-functional (Cog-Fun) Intervention for Children With ADHD

Scientific Rationale: Many children with ADHD have serious difficulties in participation in daily occupations in their ecological settings. These difficulties have a pervasive negative impact on their everyday functioning and quality of life (QoL). Although pharmacological treatment has been proven effective in treating ADHD symptoms in many children, as have psychosocial interventions such as parent training, there is little evidence for integrative approaches that address the cognitive, volitional and social-environmental barriers to participation with this population. Although preliminary positive effects of a cognitive-function (Cog-Fun) treatment in occupational therapy on this population have been demonstrated, additional evidence is needed to confirm these initial findings. Methods: Initial results of our pilot study (N=17 children with ADHD) demonstrated significant moderate to large effects of Cog-Fun treatment, which targeted participation and executive functions in daily life. Significant effects were also found for a measure of self-efficacy and neuropsychological measures of attention, planning and organization. Parent ratings showed significant reduction of ADHD symptoms and improved QoL. The purpose of the current study is to replicate the pilot study findings in a randomized controlled trial. The study will be a randomized controlled trial with a crossover design, including 2 groups of children with ADHD attending elementary school and their parents. The research group (Group A, n=50) will receive three months of the Cog-Fun treatment, designed for a parent/child dyad and the control group (Group B, n=50) will be wait-listed and receive treatment after three months. Outcomes will include measures of participation, executive functions in daily life, child and parental self-efficacy, ADHD symptoms and QoL. The investigators expect to find a significant main effect of time (pre-post intervention), group (research vs. control) and a significant interaction effect (group x time) on executive and occupational outcome measures.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of ADHD
* 7-10 years old
* regular education system
* no moderate or severe neurological and/or psychiatric disorders

Exclusion Criteria:

* moderate or severe neurological and/or psychiatric disorders
Viscosupplementation in the Hip Following Hip Arthroscopy

Hip arthroscopy is a rapidly evolving procedure that has seen an exponential increase in the number of cases performed yearly. With hip arthroscopy still in its infancy in relation to knee and shoulder arthroscopy, there are still many questions yet to be answered. Axioms that were once thought to be true regarding indications and treatment for hip arthroscopy are continually being revised. As with the knee and shoulder before it, the hip is now graduating into treatment avenues that were otherwise thought to only be possible through an open surgical procedure.

Viscosupplementation in patients post arthroscopy with known articular cartilage injury has been shown to be efficacious. The pathophysiology of hyaline degradation during the arthritic process within the knee has been studied, and with this understanding has grown the widespread usage of viscosupplementation. While questions still exist regarding the effectiveness of viscosupplementation in non-weightbearing joints, it appears the benefits seen in the weight bearing joints, such as the knee, are apparent


Eligibility Criteria:
Inclusion Criteria:

Preoperative inclusion criteria will be made via x-ray and MRI evaluation. These criteria shall include: 2 mm or greater joint space preservation of the hip on radiographs, absence of acetabular subcortical bone cysts, Tonnis Score less than 2 on radiographs, and patient age greater than 18.4 Intra-operative evaluation of the cartilage will be performed by the surgeon on both the acetabular and femoral head sides. Patients shall be included if the osteochondral defect meets Outerbridge Classification criteria of stage II or greater. Furthermore the lesion shall be greater than 1cm in size (and thus not amenable to other procedures such as microfracture). Subjects must be willing to sign the IRB-approved informed consent and be older than 18 years old.

Exclusion Criteria:

All patients 55 years of age and older. All patients with previous hip surgery on a concomitant side. Patients who present a history of radiculopathy or regional pain syndrome. Patients with a worker's compensation claim or pending litigation claim. Patients with Outerbridge Grade IV changes on either acetabular or femoral articular cartilage.
12-years Follow-up on 166 Female Patients With Fibromyalgia or Chronic Widespread Pain

A 12-year follow-up of 166 women with fibromyalgia (FM) or chronic widespread pain (CWP) in western Sweden.

The 166 women participated in a Randomised Controlled Trial called GAU in 2004-2005, aiming to investigate the effect of pool exercise and patient education.

The primary aim of the present study is to examine the change of symptoms after 11-12 years in 166 women with FM or CWP and also investigate predictors of change of symptoms and work ability.

The 166 women will be asked to participate in the present follow-up study. The follow-up examination comprises a standardised interview of symptoms and demographic variables, a battery of self-administered questionnaires and tests of physical function.

A 12-year follow-up of 166 women with fibromyalgia (FM) or chronic widespread pain (CWP).

The 166 women participated in a Randomised Controlled Trial called GAU 2004-2005 in three cities in western Sweden; Göteborg, Alingsås and Uddevalla. The RCT aimed to investigate the effect of pool exercise and patient education.

The primary aim of the present study is to examine the change of symptoms after 11-12 years in 166 women with FM or CWP and also investigate predictors of change of symptoms and work ability.

The 166 women will be contacted by mail and telephone, and asked to participate in the present follow-up study.

The follow-up examination comprises a standardised interview of symptoms and demographic variables, a battery of self-administered questionnaires and tests of physical function.

Eligibility Criteria:
Inclusion Criteria of the present study GAU-U:

* All 166 patients who participated in the study GAU in 2004/2005. (The inclusion criteria of GAU was women with FM or CWP, 18-60 years old. Patients with widespread pain; pain in the right and left side of the body, above and below the waist, as well as axial pain, for at least three months were classified as chronic widespread pain (CWP). Patients who fulfilled the criteria for CWP and who also had pain at palpation of at least 11 of 18 pre-defined tender points were classified as fibromyalgia (FM).

Exclusion criteria for GAU was serious physical or psychological disease)

Exclusion Criteria of the present study GAU-U:

* Patients who has developed serious physical or psychological disease since participating in the GAU 2004/2005
Prediction of Everolimus-induced Interstitial Lung Disease

The investigators will determine which factors are predictive for the development and severity of everolimus-induced interstitial lung disease and will develop a prediction model based on these risk factors.

In this study the investigators will prospectively investigate pulmonary adverse events during treatment with everolimus. The investigators will distinguish the following everolimus-induced pulmonary adverse events: pulmonary infection, everolimus-induced airway disease and everolimus-induced interstitial lung disease (ILD). The investigators will investigate the predictive value of pneumoproteins, everolimus exposure, pulmonary function tests, four distinct radiological patterns, baseline patient characteristics and the development of skin toxicity or oral mucositis for the development and severity of everolimus-induced ILD.

Eligibility Criteria:
Inclusion Criteria:

* Adult women with metastatic or locally advanced breast cancer not amenable to curative treatment by surgery or radiotherapy.
* Histological or cytological confirmation of estrogen-receptor positive (ER+) breast cancer
* Postmenopausal women
* Radiological or clinical evidence of recurrence or progression on last systemic therapy prior to enrollment
* Resistance to treatment with a non-steroidal aromatase inhibitor
* Serum platelets ≥ 100x10E9/l
* Everolimus dose adjustment is recommended for patients with hepatic impairment (Child-Pugh A/B/C)
* Performance status ECOG 0 - 2 (Karnofsky index: 60 - 100)

Exclusion Criteria:

* Patients with a HER2-overexpressing tumor
* Known hypersensitivity to mTOR inhibitors, e.g. sirolimus (rapamycin).
* Patients with a known history of HIV seropositivity or hepatitis B or C
* Uncontrolled diabetes mellitus
* Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of study drugs (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome)
* Patients being treated with drugs recognized as being strong inhibitors or inducers of the isoenzyme CYP3A
Safety and Efficacy of an Investigational Drug Versus Placebo in the Treatment of Cancer Pain (0663-083)

The purpose of this study is to compare the effectiveness of an investigational drug versus placebo in the treatment of metastatic bone cancer pain in patients diagnosed with breast or prostate cancer and a bone neoplasm. Patients in the study will be taking opioids to treat moderate to severe pain for their bone metastases and will remain on their opioids during the entire course of the study.


Eligibility Criteria:
Inclusion Criteria:

* Patients are required to have a diagnosis of breast or prostate cancer with bone involvement and moderate to severe pain that requires opioid treatment.
Cold and Heat Investigation to Lower Levels of Depression

This study will recruit 112 medically healthy adults (aged 18-65) currently experiencing depressive symptoms to be randomized to receive either a single Whole Body Hyperthermia (heat therapy) treatment or a Whole Body Hyperthermia treatment followed by a cold water plunge. Participants will complete a baseline assessment of their depressive symptoms as well as 1-week and 2-week post-treatment followup assessments.

The CHILL'D Study aims to figure out how using heat exposure as a treatment for major depressive disorder (MDD) can work better. The researchers want to see if being exposed to heat followed by cold plunge can help people feel better emotionally compared to just being exposed to heat alone.

The researchers hypothesize that adding cold plunge to heat exposure will enhance the antidepressant effect of heat exposure alone.

To answer study questions, 112 adults, ages 18 to 65 experiencing depression for at least 60 days and who meet study eligibility criteria, will be randomized to receive either 1) a single session of heat exposure or 2) a single session of heat exposure followed immediately by cold plunge.

Participants in the heat exposure alone group will receive a single heat session using the Clearlight Sauna Dome lasting up to 140 minutes. Participants in the heat exposure and cold plunge group will receive a single heat session using the Clearlight Sauna Dome lasting up to 140 minutes followed by a cold plunge session lasting up to 10 minutes.

Eligibility Criteria:
Inclusion Criteria:

* Meets DSM 5 criteria for major depressive disorder (MDD) with a depressive episode of ≥ 60 days duration.
* Montgomery-Asberg Depression Rating Scale (MADRS) score ≥ 28 at screening
* English or Spanish speaking (able to provide informed consent and complete questionnaires in one of these languages)
* Able and willing to adhere to trial requirements, including attending all trial visits, preparatory and follow-up sessions, and completing all trial evaluations.

Exclusion Criteria:

* Previous adverse reaction to hypothermia, hyperthermia and/or infrared exposure
* Use of any medication that may impact thermoregulatory capacity.
* Pregnancy, active lactation, or intention to become pregnant during the study period.
* Endorses current active suicidal ideation with a plan or made a suicide attempt in the prior 6 months.
Adult Accuracy Study of the Enlite 3 Glucose Sensor

The purpose of this study is to demonstrate the performance of the Enlite 3 Sensor over 168 hours (7 days) when inserted in the abdomen and used with the Guardian Mobile App and 640G Pump in subjects aged 14-75 years with type 1 or type 2 diabetes.

This study is a multi-center, randomized, in-clinic trial that aims to demonstrate the performance of the Enlite 3 Sensor over 168 hours (7 days) when inserted in the abdomen and used with the Guardian Mobile App and 640G Pump in subjects aged 14-75 years with type 1 or type 2 diabetes for at least one year.

Subjects are randomized into either Group A or Group B. The groups assigned will determine when the subject will be participating in the in-clinic YSI frequent sample testing (FST). For example on Day 1: Group A begins FST 30 minutes after Enlite 3 Sensor Insertion. Group B begins FST 14 hours after Enlite 3 Sensor Insertion.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is 14-75 years of age at time of screening
2. A clinical diagnosis of type 1 or type 2 diabetes for a minimum of 12 months duration as determined via medical record or source documentation by an individual qualified to make a medical diagnosis
3. Adequate venous access as assessed by investigator or appropriate staff
4. Subjects participating in the high and low glucose challenges must have an established insulin carbohydrate ratio(s) and insulin sensitivity ratio. (The term "established" refers to a ratio that has been previously defined and tested prior to screening visit). Subjects without established ratios may participate under observation only.

Exclusion Criteria:

1. Subject will not tolerate tape adhesive in the area of Enlite 3 Sensor placement as assessed by qualified individual
2. Subject has any unresolved adverse skin condition in the area of the Enlite 3 Sensor or device placement (e.g. psoriasis, rash, Staphylococcus infection)
3. Subject is actively participating in an investigational study (drug or device) in the last 2 weeks
4. Subject is female and has a positive pregnancy screening test
5. Females of child bearing age and who are sexually active should be excluded if they are not using a form of contraception deemed reliable by the investigator
6. Subject is female and plans to become pregnant during the course of the study
7. Subject has had a hypoglycemic seizure within the past 6 months
8. Subject has had hypoglycemia resulting in loss of consciousness within the past 6 months prior to screening visit
9. Subject has had an episode of diabetic ketoacidosis (DKA) within the past 6 months prior to screening visit
10. Subject has a history of a seizure disorder
11. Subject has central nervous system or cardiac disorder resulting in syncope
12. Subject has a history of myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack (TIA), cerebrovascular accident (CVA), angina, congestive heart failure, ventricular rhythm disturbances or thromboembolic disease
13. Subject has a hematocrit (Hct) lower than the normal reference range
14. Subject has a history of adrenal insufficiency
25G and 22G Puncture Needles

The screened patients were randomly assigned 25G puncture needles and 22G puncture needles in a 1;1 ratio, based on the computer-generated random order, before receiving an ultrasound endoscope puncture. Each puncture needle puncture lesions 2 needles, the same type of puncture needle tissue samples taken in the same tissue pathology bottle, all tissues after the completion of the necessary cytological smears, are placed in the Formalin solution to send tissue pathology, pathologists do not know the order of distribution of 2 puncture needles to evaluate the tissue results, all pathology results are reported by the hospital pathology center, audit.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of real pancreatic swelling or submuscular swelling;
* Patients need to be guided by ultrasound endoscopy under the guidance of puncture to eliminate malignant lesions or clear lesions;
* Fully communicate before surgery, understand the risks and benefits of endoscopic operation, and sign an informed consent form.

Exclusion Criteria:

* There are endoscopic operation contraindications, including abnormal blood clotting, or long-term oral anticoagulant antiplatelet drugs, can not guarantee INR \< 1.5, or platelets less than 5 x 10 x 9 / L;
* Pregnant woman