cyrilzakka/clinical-trials huggingface dataset:
All-trans Retinoic Acid (ATRA) in the Treatment of Recurrent/Metastatic Adenoid Cystic Carcinoma of the Head and Neck

This is a prospective, open-label, randomized controlled clinical intervention study to evaluate the efficacy and safety of all-trans retinoic acid (ATRA) in treating patients with recurrent metastatic adenoid cystic carcinoma of the head and neck.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years, male or female; 2. ECOG PS (performance status) score: 0-1; 3. Pathologically or histologically confirmed advanced, recurrent/metastatic ACC, with measurable disease (≥10 mm by spiral CT scan, meeting RECIST 1.1 criteria); 4. Patients with therapeutic indications; 5. Main organ functions normal, i.e., meeting the criteria below:

1. Criteria for routine blood test: (no blood transfusion within 14 days)

   1. HB ≥ 90 g/L;
   2. WBC ≥ 3.5 × 109/L and \< 10 × 109/L;
   3. ANC ≥ 1.5 × 109/L;
   4. PLT ≥ 80 × 109/L
2. Criteria for biochemical tests:

   1. BIL \< 1.25 × upper limit of normal (ULN)
   2. ALT and AST \< 2.5 × ULN; in the presence of metastases to liver, ALT and AST \< 5 × ULN;
   3. Serum Cr ≤ 1 × ULN, endogenous creatinine clearance \> 50 mL/min (Cockcroft-Gault equation); 5. Subjects who volunteer to participate in this study, sign the informed consent, have good compliance and cooperate in follow-up; 6. Patients who, in the doctor's opinion, can benefit from the treatment.

Exclusion Criteria:

1. Previous or existing concomitant malignancies except cured skin basal cell carcinoma or cervical carcinoma in situ;
2. Coagulation abnormal (INR\>1.5, APTT\>1.5×ULN), history of gastrointestinal hemorrhage in the past 6 months or bleeding tendency \[e.g., presence of active ulcer focus in the stomach, stool occult blood (++), melena and/or hematemesis, hemoptysis in the past 3 months\];
3. Confirmed hypersensitivity to ATRA;
4. Grade I and above coronary artery diseases, arrhythmias \[including QTc prolongation (males: \> 450 ms, females: \> 470 ms)\] and cardiac dysfunction;
5. Presence of multiple factors affecting oral administration (e.g. dysphagia, nausea, vomiting, chronic diarrhea and intestinal obstruction, etc.);
6. Pregnant or lactating women;
7. History of psychotropic abuse with abstinence failure, or existing mental disorder;
8. Participation in other drug clinical trials within 4 weeks;
9. Other concomitant diseases which seriously jeopardize the patient's safety or prevent the patient from completing the study, as judged by the investigator.
In-patient Study With GSK716155 In Patients With Type 2 Diabetes Mellitus

This study is a placebo-controlled study in patients with Type 2 Diabetes Mellitus to assess safety and tolerability parameters, the levels of GSK716155 in the bloodstream when it is given at the same dose 7 days apart, and the impact this medication has on various substances in the blood. Assessments include ECGs, vital signs, repeat blood sampling and monitoring of any side effects.


Eligibility Criteria:
Inclusion criteria:

* Subjects must have type 2 diabetes mellitus that has been diagnosed for at least three months.
* Must be taking either (1) no medication for their diabetes or (2) taking metformin, a sulfonylurea, or metformin and a sulfonylurea.
* Subjects must be willing to wash-out of these medications for 14 days prior to the start of the study.
* Subjects must have a BMII between 25 and 40 kg/m² and weigh at leas 50kg.
* Women must be of non-childbearing potential.

Exclusion criteria:

* Laboratory values that meet certain criteria (for example, total cholesterol \> 240 mg/dL).
* Clinically significant hepatic enzyme elevation.
* Fasting plasma glucose greater than 240mg/dL.
* Positive test result for Hepatitis B surface antigen, positive Hepatitis C or HIV.
* Any major illness other than diabetes.
* Previous use of insulin as treatment for diabetes.
* Significant renal disease as defined by screening lab tests.
* History of drug or other allergy, which in the opinion of the investigator contradicts subject participation.
* Smoking or use of nicotine-containing products within the previous 6 months.
* History of alcohol or drug abuse.
* Unwilling to abstain from alcohol during the study.
* Unwilling to abstain from caffeine- or xanthine-containing products during the study.
* Use of St. John's Wort during the study.
* Has donated 500 nL or more blood within 56 days of dosing or plans to donate blood in the month following study participation.
* Previously received any GLP-1 mimetic that has moe than 70% sequence homology to GLP-1.
Safety of Lopinavir/Ritonavir (Kaletra) in HIV/HCV Co-infected Subjects vs Baseline Liver Biopsy Metavir Score

The purpose of this study is to evaluate clinical response and safety of a Kaletra containing antiretroviral treatment regimen in HIV positive subjects with HCV coinfection.


Eligibility Criteria:
Inclusion Criteria:

* Documented HIV positive.
* At least 18 years of age.
* Does not exhibit evidence of acute illness (especially any acute liver disease, except hepatitis C)
* Subject has not been treated for an active opportunistic infection within 30 days of the baseline visit.
* Subject Has a Karnofsky Score greater than or equal to 70.
* Subject does not require and agrees not to take, for the duration of the study, any of the following medications that are contraindicated with Kaletra: astemizole, terfenadine, midazolam, triazolam, cisapride, certain ergot derivatives (ergotamine, dihydroergotamine, ergonovine, and methylergonovine), pimozide, propafenone and flecainide. Rifampin, a potent enzyme inducer, should not be administered with the study medication, because of the possibility of significant decreases in Kaletra concentration during concurrent administration.
* The subject agrees not to take any medication, including over-the-counter medicine, alcohol, recreational drugs or herbal preparations without the knowledge and permission of the principal investigator.
* Subject had laboratory testing within the previous three months and the most recent testing demonstrates all of the following: Hemoglobin\> 8.0 g/dL; absolute neutrophil count \> 750 cells/mL; Platelet count \> 20,000/mL; ALT or AST \</=10 x upper limit of normal (ULN); Creatinine\< 1.5 x ULN; Triglycerides \</=750 mg/dL.
* Subjects have no evidence of grade III or IV adverse event or laboratory abnormality (except for LFTs).

Exclusion Criteria:

No exclusion criteria.
Trial of Paclitaxel, Bevacizumab, and Enzastaurin Versus Paclitaxel, Bevacizumab and Placebo for Breast Cancer

The purpose of this study is to determine efficacy and safety of paclitaxel, bevacizumab and enzastaurin versus paclitaxel, bevacizumab, and placebo in participants who are diagnosed with locally recurrent or metastatic breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Must have signed an inform consent document
* Have histologic or cytologic diagnosis of breast cancer with evidence of unresectable locally recurrent or metastatic disease
* Have not received any prior chemotherapy for locally recurrent or metastatic disease
* Have not had adjuvant or neoadjuvant taxane therapy within 12 months prior to assignment to study treatment
* Age 18 years or older at time of informed consent

Exclusion Criteria:

* Have any clinical evidence of central nervous system (CNS) metastases
* Have a history of seizure
* Have had a major surgical procedure within 4 weeks prior to assignment to study treatment
* Have had a minor surgical procedure, placement of an access device, or fine needle aspiration within 7 days prior to assignment to study treatment
* Have symptomatic peripheral vascular disease
Quetiapine Efficacy in Bipolar Depression Study

To reassure the clinical study data on Seroquel antidepressant efficacy in patients who are diagnosed as bipolar depression


Eligibility Criteria:
Inclusion Criteria:

* The patient and the patient's legal representative (if any) must understand the nature of the study and must have given written consent
* Meet DSM-IV-TR criteria for bipolar depression at the time of baseline

Exclusion Criteria:

* Since this programme intends to describe quetiapine use in routine clinical practice when prescribed as treatment of bipolar depression, there are no programme specific exclusion criteria, other than:

Or, any of the following is regarded as a criterion for exclusion from the programme:

1. Serious or unstable, medical illness. Subjects with chronic illness may be included but must be stable and otherwise physically healthy on the basis of a physical examination, medical history
2. Known intolerance for or lack of response to quetiapine, as judged by the investigator
Data Collection for Next Generation Ultrasound Technology Development

The study is designed to collect data from a ultrasound device being used to evaluate feasibility of next generation algorithms for ultrasound data processing and does not test any health outcome.

The study is designed to collect data from a ultrasound device being used to evaluate feasibility of next generation algorithms for ultrasound data processing and does not test any health outcome. All eligible adults (aged 18 or older) will contribute case data from a convenience sample of maintenance hemodialysis population available at the study site and consistent with feasibility assessment of the technology. A relatively large feasibility population is used due to the need to test feasibility of multiple features across variations within this population.

Eligibility Criteria:
Inclusion Criteria:

1. Are adults (aged 18 years of age or older) at the time of consent;
2. Are undergoing maintenance hemodialysis (MHD); AND
3. Are able and willing to provide written informed consent for participation

Exclusion Criteria:

1. Have anatomical characteristics or comorbid medical conditions that prevent completion of ultrasound scanning using the study device; OR
2. Are potentially put at additional risk by participating, in the opinion of the investigator.
Comparative Efficacy of 3L and 2L Integrated Techniques for Gynecologic Cancer-related Lower Extremity Lymphedema: a Retrospective Study

The goal of this retrospective study is to evaluate the long-term efficacy of 3L versus 2L integrated techniques in patients with gynecologic cancer-related lower extremity lymphedema (GCR-LEL). The main research question is:

Do 3L integrated techniques provide superior long-term outcomes in reducing lower extremity lymphedema compared to 2L techniques in patients with GCR-LEL?

Medical records of patients who have received either 3L or 2L integrated interventions as part of their routine clinical management for GCR-LEL were reviewed and analyzed to assess treatment outcomes over an extended follow-up period.


Eligibility Criteria:
Inclusion Criteria:

1. The patients diagnosed with gynecological cancer-related lymphedema by clinical examination are classified by the International Lymphedema Society (ISL) guidelines as Stage II to III.
2. .Aged 18-90 years.

Exclusion Criteria:

1. Lactation, for patients with pregnancy;
2. Serious heart, lung, liver, kidney disease, as well as the history of tumor patients;
3. Disease history is less than 3 months;
4. In patients with mental illness;
5. Immunodeficiency patients.
Weight Management Intervention in College: a Pilot Study

This Proof-of-Concept study consists of a series of uncontrolled pilot studies to refine a behavioral weight loss trial using a "small change" approach for emerging adult college students with overweight/obesity. The primary aim of this study is maximize student acceptability of the intervention and weight loss outcomes.

Forty percent of emerging adults (age 18-25) have overweight or obesity, which is unlikely to remit and has significant health consequences. However, emerging adults are underrepresented in traditional weight loss programs, drop-out at high rates, and have blunted weight loss outcomes. One potential way to improve participation is to offer BWLIs in college health service centers to reduce barriers to participation. Approximately 40% of emerging adults are enrolled in a postsecondary institution and college health centers are used widely by students. Moreover, delivering an intervention with design features that are responsive to emerging adult preferences and lifestyles may also improve intervention effectiveness and attractiveness. The "small change" (SC) approach to weight loss addresses emerging adult barriers to engagement by focusing on reducing calories through a few self-selected, specific changes to current obesogenic behaviors, requiring less time and effort than traditional behavioral weight loss interventions (BWLI) and promoting autonomy and self-efficacy. The SC approach has been used effectively for weight loss in other populations. This proof-of-concept study is part of a larger study that aims to develop and refine a novel and effective BWLI based on a SC approach that is designed for emerging adults and for implementation in college health centers, an accessible care setting. The primary aim of this proof-of-concept study is to iteratively test and refine the intervention to maximize student acceptability and weight loss outcomes.

Eligibility Criteria:
Inclusion Criteria:

* BMI of 25 or greater
* Enrolled at college/university where study will take place
* English-speaking

Exclusion Criteria:

* History or current diagnosis of anorexia nervosa, bulimia nervosa, or alcohol use disorder (current symptoms also assessed at screening using validated screening questionnaires)
* Participation in another formal weight loss program
* Current or recent pregnancy
* Psychiatric hospitalization in the past 12 months
* Recent weight loss of 5% body weight or more
* History of bariatric surgery
* Severe food or physical activity restrictions that would interfere with treatment recommendations
Case-Control-Study on the Breast Cancer Risk of Mirena® Compared With Copper IUDs

The objective of this study is to determine the breast cancer risk of Mirena® users compared to copper intrauterine device (IUD) users in a community-based case-control study.

This is a community-based case-control study in Germany and Finland. Cases will be identified from cancer registries, tumor centers and breast centers. Matched controls will be accrued from the same region as the case came from. Breast cancer cases and their controls are women under 50 years of age without known history of malignancies.

Cases are women with a breast cancer who are younger than 50 years of age at cancer diagnosis. The breast cancer was diagnosed between January 2000 and December 2007. Only alive cases and cases in a sufficiently good health status to be interviewed are eligible for the study.

Controls are women without a breast cancer diagnosis who are younger than 50 years of age at the time of the interview. About 3 controls matched by year of birth and region will be allocated to each case.

A standardized questionnaire will be used for all breast cancer cases and controls. The questionnaire will be mailed to cases and controls.

Study participants will be asked for their informed consent. Data confidentiality according to national laws will be ensured by the field organizations.

Eligibility Criteria:
Inclusion Criteria:

* cases: women with a breast cancer who are younger than 50 years of age at cancer diagnosis
* controls: women without a breast cancer diagnosis who are younger than 50 years at the time of the interview

Exclusion Criteria:

* women who are not willing to participate
Fixation of Displaced Midshaft Clavicular Fractures in Adults by Intramedullary Elastic Rod

Clavicular fracture, constitutes 2.6% e 5% of all adult fractures, most are located in the midshaft clavicle with different degrees of displacement. Conservative methods are commonly used for midshaft clavicular fractures treatment, but with various unsatisfactory complications such as nonunion, malunion and shoulders asymmetry. The rate of malunion after conservative treatment for the midshaft clavicular fractures reached 15%, and 30% patients were unsatisfied. Recently, early midshaft clavicular fractures could greatly reduce the incidence rate of nonunion and malunion. Open reduction and plate-screw ﬁxation was considered as the gold standard with the advantages of ﬁrm ﬁxation and earlier postoperative mobilization, but also with disadvantages of larger incision and more organizations being exposed, presenting with many postoperative complications. Intramedullary ﬁxation treatment for mid-clavicular fractures has been favored due to its strengths including small incision, less periosteal striping, dispersion of stress and simple to operate However, early intra-medullary implants, such as Hagie pins and Kirschner wires, have been gradually replaced due to insufficient stability. In addition, various nails such as elastic stable intramedullar

Fixation of displaced midshaft clavicular fractures with minimally invasive technic as it helps for early mobilization to the shoulder and more safe, more cosmetically in comparison to other options.

Eligibility Criteria:
Adults pt aged (16-55 ) how is active presented with mid shaft clavicular fracture, displacement with no comorbidity and excluding pt with polytrauma aged above 55y or below 16y ,pt with fracture lateral 3rd and pt with comorbidity
Use of Nesiritide (BNP) in Kidney Function in Patients With Congestive Heart Failure (CHF) and Kidney Failure

The objective of this study is to determine the safety and effectiveness of intrarenal administration of brain natriuretic peptide (BNP) in improving renal function as measured by glomerular filtration rate (GFR) and sodium excretion in patients hospitalized with acute congestive heart failure (CHF) and deterioration of kidney function (cardiorenal syndrome).


Eligibility Criteria:
Inclusion Criteria

* Age 18 years and older
* Clinical diagnosis of class III-IV CHF requiring hospitalization
* Current acute CHF decompensation
* Systolic BP \> 90 mmHg
* Stable cardiac rhythm
* Estimated creatinine clearance by the Cockcroft-Gault equation of less than or equal to 60 mL/min.
* Worsening renal function after greater than or equal to 24 hours of standard therapy as defined by a plasma creatinine concentration greater than their admission of 0.3 mg/dL and a 10% increase from hospital admission creatinine OR creatinine which remains at 0.3 mg/dL and 10% increase from baseline draw done within 4 weeks of hospitalization
* Ability to provide informed consent

Exclusion Criteria

* Patients needing emergency coronary revascularization or those who may have rapidly changing cardiac function (i.e., patients with acute myocardial infarction or shock)
* Peritoneal or hemodialysis within 90 days or anticipation that dialysis or ultrafiltration of any form will be required during the study period
* Systolic blood pressure \< 90 mmHg or cardiogenic shock
* Requirement of pressors for maintenance of blood pressure
* Intra-aortic blood pump use
* History of significant uncorrected renal artery stenosis as defined by \>50% stenosis
* Severe aortic or mitral stenosis or significant LV outflow tract obstruction
* Pregnant or nursing women
* Prisoners
* Contraindication to nesiritide
* Contraindication to heparin
* Cause of acute renal dysfunction can be reasonably ascribed to factors other than heart failure or its treatment
* Inability to have NSAID dose held for up to 30 hours, if being treated with these medications
* Ongoing treatment with calcineurin inhibitors (cyclosporine or tacrolimus)
* Administration of radiocontrast medium within 7 days of enrollment or anticipated use of such agents during the study (other than the minimal contrast required to place the renal infusion catheter)
* Known bleeding diathesis
* Known condition that would increase the likelihood of vascular perforation or trauma, dissection such as Marfan's syndrome, cystic medial necrosis, abdominal or thoracoabdominal aortic dissection, mycotic aneurysm, abdominal aneurysm, thoracoabdominal aneurysm, renal artery aneurysm, thoracic aneurysm involving the visceral region of the aorta, and severe calcification in the area of the renal arteries
* Solitary kidney or solitary functioning kidney
* Iodine allergy
A Family Dyad-focused Diabetes Self-Management Intervention for African American Adults

A family dyad-focused diabetes self-management for African American adults with type 2 diabetes is a randomized controlled trial (RCT) that aims to test the feasibility, acceptability, and efficacy of a family-dyad focused intervention on glycemic control (hemoglobin A1c) and health-related quality of life (HRQOL) in African American adults with type 2 diabetes (T2D).

Eligible participants and their family members will be randomly assigned to either the intervention and control group. Patient-family-member dyads in the intervention arm will virtually receive 1) 10 session over 12 weeks of family dyad-focused, group sessions on diabetes self-management and family support; 2) family dyad-focused support component in each group session; and 3) individual family feedback telephone sessions. All participants will be assessed at baseline, post-intervention and six months after intervention.

Eligibility Criteria:
Inclusion Criteria:

Individual with type 2 diabetes:

* Self-identification as African American;
* 40 years or older
* Type 2 diabetes diagnosis for at least six months;
* A1c \> 7.0% at time of enrollment;
* Being able to speak and read English;
* Being able to walk;
* Having an adult family member/close friend willing to co-participate in the study.

Family members:

* Adults (18 years or older, with or without T2D);
* Residing in the same household as the T2D participants;
* Being a spouse, adult child or sibling; or close friend
* Being able to walk;
* Being able to speak and read English.

Exclusion Criteria:

Individual with T2D and family members:

* Being pregnant or have an advanced or terminal condition;
* Being cognitively impaired or unable to provide informed consent;
* Lack conclusive evidence of T2D for patients with T2D.
Psilocybin vs Escitalopram for Major Depressive Disorder: Comparative Mechanisms

This is a randomised double-blind clinical trial. The aim is to compare the efficacy and mechanisms of action of psilocybin, the primary psychoactive substance in 'magic mushrooms', with the selective serotonin reuptake inhibitor (SSRI) escitalopram for major depressive disorder (MDD).


Eligibility Criteria:
Inclusion Criteria:

1. Major depressive disorder (DSM-IV)
2. Depression of moderate to severe degree (17+ on the 17-item Hamilton Depression Scale (HAM-D)).
3. No Magnetic Resonance Imaging (MRI) contraindications
4. No SSRI contraindications
5. Has a general practitioner (GP) or other mental healthcare professional who can confirm diagnosis
6. 18-80 years of age
7. Males and females
8. Sufficiently competent with English language

Key exclusion criteria:

1. Current or previously diagnosed psychotic disorder
2. Immediate family member with a diagnosed psychotic disorder
3. Medically significant condition rendering unsuitability for the study (e.g., diabetes, epilepsy, severe cardiovascular disease, hepatic or renal failure e.g. creatine clearance:renal clearance (CLRC) \< 30 ml/min etc.)
4. History of serious suicide attempts requiring hospitalisation.
5. Significant history of mania (determined by study psychiatrist and medical records)
6. Psychiatric condition judged to be incompatible with establishment of rapport with therapy team and/or safe exposure to psilocybin, e.g. borderline personality disorder
7. Blood or needle phobia
8. Positive pregnancy test at screening or during the study, women who are planning a pregnancy and/or women who are nursing/breastfeeding.
9. Participants who do not agree to use an acceptable contraceptive method throughout their participation in study.
10. Current drug or alcohol dependence
11. No email access
12. Use of contraindicated medication
13. Patients presenting with abnormal QT interval prolongation at screening or with a history of this (QTc at screening above 440ms for men and above 470ms for women)