cyrilzakka/clinical-trials huggingface dataset:
Omacetaxine for Consolidation and Maintenance

The purpose of this pilot study is to assess the safety and tolerability of omacetaxine for consolidation in patients age 55 and older with acute myelogenous leukemia (AML) in first complete remission following induction with cytarabine and an anthracycline, and also to assess the safety and tolerability of omacetaxine for maintenance in patients age 55 and older with acute AML in first complete remission following 3 consolidation courses with omacetaxine.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of AML including de novo, secondary, or with an antecedent hematologic disorder (AHD) according to the World Health Organization (WHO) criteria.
2. Age ≥ 55 years.
3. Patient eligible for standard induction chemotherapy based on Eastern Cooperative Oncology Group (ECOG) performance status and vital organ function at the discretion of the treating physician.
4. Patients who received 1-2 cycles of hypomethylating therapy (decitabine azacitidine) are eligible.
5. Provide signed written informed consent.
6. Be able to comply with study procedures and follow-up examinations.
7. Be non-fertile or agree to use birth control during the study through the end of last treatment visit.
8. Adequate renal and hepatic function at the time of second registration:

   * Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN); and
   * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN; and
   * Serum creatinine ≤ 1.2 x ULN.
9. ECOG performance ≤ 2 at the time of second registration.
10. Patients with a history of carcinoma in remission, on no therapy or on hormonal therapy for the adjuvant treatment of breast carcinoma or prostate carcinoma are included in the study.

Exclusion Criteria:

1. Diagnosis of acute promyelocytic leukemia (APL, French-American-British \[FAB\] classification M3 or WHO classification of APL with t (15;17)(q22;q12), (PML/retinoic acid receptor alpha \[RARa\] and variants).
2. Prior treatment with omacetaxine.
3. Relapsed or refractory AML.
4. Investigational agent received within 30 days prior to the first dose of study drug. If received any investigational agent prior to this time point, drug-related toxicities must have recovered to Grade 2 or less prior to first dose of study drug.
5. Psychiatric disorders that would interfere with consent, study participation, or follow-up.
6. Systemic fungal, bacterial, viral, or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment).
7. Any other severe concurrent disease, or have a history of serious organ dysfunction or disease involving the heart, kidney, liver, or other organ system that may place the patient at undue risk to undergo the proposed therapy. This includes uncontrolled hypertension and uncontrolled diabetes, as cases of life threatening hyperglycemia have been reported (using continuous infusion at higher doses of omacetaxine).
8. Active carcinoma requiring systemic chemotherapy or radiation therapy.
Clinical Trial to Compare the Efficacy of a Fluoride Gel and a Dental Bonding Agent in Treatment of Tooth Sensitivity

This study compares the efficacy of two dental interventions in the treatment of cervical dentine sensitivity. The participants will be selected from adult dental patients registered at a general dental practice in West Sussex, UK. The participants will be split into 2 groups. One group will receive the intervention of topical fluoride varnish application while the other group will receive a topical application of self-etching dentine bonding agent.

Topical Fluoride Varnish(TFV) and Self-Etching Dentine Bonding Agent (SEDBA) are both routinely used in dentistry in the management of cervical dentine sensitivity(CDS). Both interventions are topically applied and well tolerated by patients. The interventions differ in mechanism of action. TFV releases fluoride which is incorporated into the organic matrix of dentine making the dentine tubules less conductive. Dentinal tubules form the key conduit between stimulus and pain perception in the tooth. SEDBA differs in that it penetrates and occludes the tubules. It is light cured for an almost instant set time.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18-60.
* Exhibiting CDS elicited by the two test stimuli in relation at least one tooth.

Exclusion Criteria:

* Patients who have undergone comprehensive periodontal treatment in the past 3 months.
* Patients under the age of 18 or unable to provide valid consent.
* Teeth that have visible fracture lines, caries, crowns or have been endodontically treated.
* Patients taking analgesic medication for any systemic conditions.
Qing'E Formula Therapy on Menopausal Symptoms

The objective of this study is to evaluate whether a Chinese medicine formula (Qing'E) is effective in alleviating menopausal symptoms and safety.

This is a double-blind placebo-controlled randomized clinical trial to evaluate whether a Chinese medicine formula (Qing'E, composed of eucommia, psoralen, walnuts and garlic) is effective in alleviating menopausal symptoms. 240 Chinese women with menopausal symptoms will be recruited and randomized into two groups. One is treatment group with 12 weeks of Qing'E pills (well-controlled), the other is controlled group with 12 weeks of placebo. The treatment outcome measures include: 1) the severity of menopausal symptoms: self-recording of daily frequency of vasomotor symptoms (hot flushes), the Kupperman index. 2) NEI network indices. 3) Urine metabolomics. All measures are conducted at baseline and endpoint except the self-recoding of vasomotor symptoms, Kupperman index and urine metabolomics. Tyhe investigators expect this research will provide an effective and safe therapy for menopausal symptoms.

Eligibility Criteria:
Inclusion Criteria:

1. Women age between 40 to 60 Years, Suffering from irregular menstrual cycle or amenorrhea of 3-11 months.
2. Moderate to severe hot flashes (associated with sweating)≥5 times /24 hours.
3. Patients unused estrogen tablets or progesterone injection in 6 months.
4. Patients must discontinue other therapies in the treatment of menopausal syndrome for more than 3 months.
5. Get subjects informed consent process should comply with GCP requirements.

Exclusion Criteria:

1. Patients with hypertension, primary hypotension and chronic anemia (Hb ≤ 90 g / L).
2. Bilateral oophorectomy, endometrial lesions, uterine polyps, abnormal vaginal bleeding, severe breast hyperplasia, with family history of breast cancer.
3. Allergic constitution and known allergy to the drug.
4. Patients with diseases of the cardiovascular, cerebrovascular, liver, kidney and hematopoietic system, or mentally ill.
5. Patients with hyperthyroidism, coronary atheroma, diabetes, obesity (body mass index of more than 30 kg/m2), migraine, malignant tumors, thromboembolic disease, gastrointestinal diseases affect absorption or autoimmune diseases.
6. Alcoholics or smokers (past or smoking).
7. Patients are participating in other clinical trials.
Effectiveness & Safety of Promelaxin® Microenemas Against Macrogol 4000 P.O. in Chronic Constipation in Children 6-48 Months

The study is aimed at the efficacy and safety evalutation of the study treatments through a 2-weeks study period and the subsequent follow-up-

This multicenter, prospective, randomized, controlled trial will be conducted on 120 infants-children with a diagnosis of chronic functional constipation according to the definition of Criteria of Rome III. The enrolled subjects will be randomized according to an electronically generated randomization list in 2 groups: one group will receive micro-enemas of Promelaxin® (Group A) while the second group will receive Macrogol 4000 per os (Group B) . Children will receive the dedicated treatment for two weeks and then undergo a follow-up period of a maximun of 6 weeks.

The hypothesis is that the protective micro-enema will help achieving regular evacuation by its local antinflammatory non-pharmacological action. This hypothesis is based on the finding that local anal inflammation can cause functional constipation due to discomfort and pain during evacuation or by influencing reflexes.

Eligibility Criteria:
Inclusion Criteria:

* Chronic functional constipation according to Rome III criteria
* No stool softeners therapy administered during the 7 days prior to Baseline Visit
* Signature of informed consent from by both parents or legal representative
* Willingness to follow the study schedule

Exclusion Criteria:

* Suspicious or established diagnosis of organic constipation
* Delayed emission of meconium in the term newborn
* Presence of severe inflammatory bowel disease (such as ulcerative colitis, Crohn's disease), toxic megacolon
* Presence/Risk of gastroinstestinal perforation
* Presence/Suspiceous intestinal obstruction of symptomatic stenosis
* (Undeterminated) Abdominal pain
* Hypersensitivity to macrogol (polyethylene glycol) or to one or more product excipients
* Hereditary fructose intolerance
* Known hypersensitivity or allergy to any Promelaxin component
* Presence of any other medical condition that contraindicate the use of Promelaxin® or Macrogol 4000
Evaluation of Cirvo™ Mobile Compression Device for Treatment of Venous Leg Ulcers

This study in venous leg ulcer (VLU) patients will evaluate the use of Cirvo™ therapy for the treatment of VLU when applied for a minimum of two hours daily for up to 12 weeks.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients between 18 and 80 years of age
2. Patients (CEAP 6) who have not previously experienced a period of open ulceration exceeding 26 weeks in the affected leg
3. Total venous ulcer area \< 20cm2
4. Duration of therapy for active venous ulcer \<26 weeks prior to enrollment
5. Venous insufficiency documented by venous reflex ultrasound showing mild, moderate, or severe reflux in the superficial or deep venous system

Exclusion Criteria:

1. Acute DVT within the 3 months prior to enrollment
2. Ulcer present for \<2 weeks
3. Ulcers extending with exposed fascia, tendon, or bone within the wound margins
4. Lateral malleolus ulcers
5. Ulcers with perforator incompetence deep to the ulceration (within 5 cm of the wound border)
6. Active infection (systemic or in the affected limb)
7. Lower extremity gangrene
8. Diabetes mellitus (Type I or II) requiring medication
9. History of pulmonary vascular disease (PVD)
10. History of pulmonary edema
11. History of decompensated congestive heart failure (CHF)
12. Open surgery or major trauma to the legs within the last six months
13. History of lower limb malignancy, primary or secondary
14. Acute symptomatic lower extremity thrombophlebitis
15. Pregnant or breastfeeding
16. Calf geometry on which Cirvo(TM) device does not appropriately fit
17. Known sensitivity to any of the materials used in the Cirvo(TM) device
18. Currently participating or plans to participate in in any other investigational clinical evaluation during the 12 week study period that may, in the opinion of the investigator, affect blood flow and/or venous leg ulcer
The Role of Elastography in the Diagnosis of Thyroid Nodules

The primary objective of this study is to evaluate the role of elastography (along with echographic and cytological data) as a diagnostic tool for thyroid cancer

Ultrasound is considered the first line examination in the exploration of the thyroid nodule. Echotexture analysis often identifies nodules at risk of malignancy, but does not replace or exclude an additional cytological exploration. Cytology, although effective, also has limitations, particularly when samples are vesicular and it is difficult discern between a benign or malignant state. The creation of a noninvasive method in this context could help to avoid invasive tests or "useless" surgical procedures.

Ultrasound elastography, which assesses tissue deformability, may provide valuable information concerning benign soft tissue characteristics, whereas malignant lesions are harder in consistency. Interest in this method, already proposed for other organs, has recently increased due to the emergence of specifically created software that enables objective evaluation of the hardness of the nodule during a conventional ultrasound analysis. The main hypothesis of this study is that elastography should allow better selection of candidates for thyroid surgery.

Eligibility Criteria:
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
* The patient is available for six months of follow-up
* The patient is programmed for surgical excision of all nodules determined to be not benign according to cytological criteria

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 patient is pregnant
* The patient is breastfeeding
* The patient has a contraindication for a treatment used in this study
* The patient has a contraindication for surgical excision of his/her thyroid nodule
* The patient refused to be operated
Interactions Between Cocaine and Ethanol and Disulfiram - 1

The purpose of this study is to assess potential interactions between intravenous cocaine and ethanol and oral disulfiram.

This is a two-site, double blind, placebo-controlled inpatient study to determine the cardiovascular and psychiatric safety of alcohol use in cocaine-dependent subjects who had used cocaine after treatment with disulfiram.

Eligibility Criteria:
Inclusion Criteria:

* Must meet DSM-4 criteria for cocaine abuse or dependence and are not seeking treatment.
* Ability to verbalize understanding of consent form and provide written informed consent and verbalize willingness to complete study procedures; be able to comply with protocol requirements.

Exclusion Criteria:

* Please contact site for more information.
Stress in Working Life

The goal of this realist evaluation of a Danish Cognitive Behavioral Therapy (CBT)-based stress management for patients with work-related stress is to understand what works, for whom, in what circumstances.The main objectives are:

To assess the effect of the stress management intervention on sustainable return to work.

To investigate what contexts and mechanisms are associated with patients' return to work rates and level of perceived stress after having received the stress management intervention.

To understand from a patient perspective how mechanisms work in specific contexts to generate effects of the stress management intervention.

The evaluation comprises two observational studies and one interview study. The intervention cohort are patients with work-related stress who received the stress management intervention between 2012-2018.

The comparison cohort are patients who would have been eligible to receive the intervention in 2011-2012, however they did not receive any intervention because it was not offered at that time.

In study one return to work rates are compared between the intervention cohort and the comparison cohort to find out if the intervention can help patients return to work at a faster rate.

Study two will investigate if there are any explanatory variables (such as work type, civil status or level of depressive symptoms) that may explain why some patients benefit more or less from the intervention.

Study three will explore what it is about the intervention (mechanisms) the patients find are helping them to cope with stress or the opposite in specific circumstances.


Eligibility Criteria:
Inclusion Criteria:

* exposure to stressful conditions at work such as a large workload and/or stressful organisational and managerial conditions.
* Patients must be employed, and if on sick leave there must be plans for return to work during the intervention period.
* Patients must exhibit severe signs of work-related stress meaning that there must have been a significant work-related impact, the patient must have had physical, psychological, and behavioural stress symptoms for more than four weeks.

Exclusion Criteria:

* patient's work-related stress is primarily caused by cooperation problems, bullying and/or harassment,
* long-term sick leave \>26 weeks up to referral
* more severe stress load outside of work
* severe psychiatric conditions that requires treatment
* current abuse of alcohol and/or psychoactive stimulants.
Prophylactic Effect of Nirmatrelvir/Ritonavir and Ursodeoxycholic Acid on Reducing Complications After Cardiac Surgery

Prophylactic effect of nirmatrelvir/ritonavir and ursodeoxycholic acid on reducing complications after cardiac surgery during covid-19 pandemics (the pep trial) is a multicenter, randomized controlled trial. The aim of the pep trial is to investigate whether prophylactic use of nirmatrelvir/ritonavir and ursodeoxycholic could reduce complications after cardiac surgery.

After informed consent, four centers and 436 eligible admissions will be recruited. Eligible patients would be randomized (1:1:1:1) to nirmatrelvir/ritonavir group (nirmatrelvir 300mg q12h and ritonavir 100 mg q12h for 5 days), ursodeoxycholic acid group (ursodeoxycholic acid group, 15mg/kg/day bid for5 days), combination group (nirmatrelvir/ritonavir and ursodeoxycholic acid for 5days) and control group.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* COVID-19 nucleic acid test or antigen test positive history, without symptom or recover from COVID-19 related symptoms ≥2 weeks
* Receive open-chest cardiac surgery
* COVID-19 nucleic acid test and antigen test negative and no signs of pneumonia in chest CT
* Patients with written informed consent.

Exclusion Criteria:

* Emergency surgery
* eGFR ≤30ml/min
* Severe liver dysfunction
* Contraindication to nirmatrelvir/ritonavir or ursodeoxycholic acid
Expansion to Interdisciplinary HIV Prevention in Women

This trial will pilot test intervention strategies to increase utilization of HIV testing and gain knowledge for designing a clinical trial to evaluate prevention strategies to reduce HIV sexual transmission in the general population in Russia. The study will assess whether external (cost, convenience) or internal factors (low perception of own risk, reluctance to identify a partner as at-risk, fear of stigma) drive Russian women's reluctance to be tested and if peer support impacts their decision. A randomized experimental manipulation, comparing opt-in vs. bundled opt-out testing approaches, followed by focus group discussions, followed by a second-chance testing offer will be used to inform these questions. The answers will enable the international research team to engineer and then test an HIV testing promotion strategy in Russia. The project will collect preliminary data for a larger study to develop an evidence-based program to reduce the HIV transmission in this high risk population.

A mixed methods research design combining qualitative and quantitative data collection methods will be used to increase the understanding of barriers to HIV testing, identify promising strategies to increase testing, generate research hypotheses, and design a future randomized clinical trial to evaluate HIV prevention targeted to at-risk women in the general population in Russia. The qualitative methods include structured interviews and a focus group participation to assess women's reasons for being the tested and possible prevention strategies. The quantitative methods include observation/recording of women's testing behaviors.

Eligibility Criteria:
Inclusion Criteria:

* A parent study participants who completed HIV risk survey and
* Reported two or more partners in the last 12 months and no or inconsistent condom use in the last 3 months and no HIV testing in the last 12 months
* Or reported any sexually-transmitted disease and no HIV testing in the last 12 months

Exclusion Criteria:

* A parent study participants who declined to be contacted for participating in future research studies
Precision Transcranial Magnetic Stimulation for Depression Based on Orbital Frontal Cortex-habenula Circuitry

Thirty depressed patients will be recruited to select individualized transcranial magnetic stimulation targets based on individual orbital frontal cortex and habenula functional activity connectivity for 10 or 20 treatments to assess the efficacy and safety of this intervention


Eligibility Criteria:
Inclusion Criteria:

* Gender is not limited, age 18～60 years old;
* Comply with the diagnostic criteria for major depressive disorder in the Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (DSM-5) of the United States of America;
* Hamilton rating scale for depression (HAMD) 17-item score ≥ 18;
* The medication/psychotherapy received by the subject prior to the start of the study remained stable for at least 4 weeks .

Exclusion Criteria:

* History of serious somatic diseases or diseases that may affect the central nervous system (e.g., tumors, syphilis, etc.);
* Neurological disorders or risk of seizures, such as previous craniosynostosis, head trauma, alcoholism, abnormal electroencephalograms, MRI evidence of structural abnormalities in the brain, or family history of epilepsy;
* Patients with bipolar disorder and depression due to other psychiatric disorders (e.g., psychoactive and non-dependent substances);
* Contraindications to MRI scanning or transcranial magnetic stimulation therapy, such as metal or electronic devices placed in the body (intracranial metal foreign bodies, cochlear implants, pacemakers and stents and other metal foreign bodies), space phobia;
* People with psychotic symptoms requiring joint application of antipsychotic drugs;
* Those with high risk of suicide, or those who have already committed suicide or serious self-injury behavior requiring urgent intervention;
* Those who are pregnant, breastfeeding or planning to become pregnant during the trial;
* Other conditions judged by the investigator to be unsuitable as research subjects.