cyrilzakka/clinical-trials huggingface dataset:
Comprehensive Genomic Profiling Combined With Real Life Data of "The German-Registry of Incidental Gallbladder Carcinoma"

Multicenter German- Registry of Incidental Gallbladder Carcinoma combining clinical real-world data and comprehensive genomic profiling. The registry collects medical data from clinical observation and molecular data derived from archival tumor tissue samples but does not define any medical intervention nor does it evaluate the efficacy or safety of the treatment decision made by the investigator.

In the largest cohort of IGBC patients ever analysed in such a comprehensive approach

* determine the course of patients in this rare kind of cancer
* combine cGP analysis of histological tumor samples with clinical real-life data to get a comprehensive overview on IGBC patients analysed and evaluate data to identify possible further (targeted) treatment possibilities
* analyze potential risk factors associated with gallbladder carcinoma
* assess the frequency of targetable mutations in IGBC

Eligibility Criteria:
Inclusion Criteria:

Histologically confirmed diagnosis of incidental gallbladder carcinoma

* Patient ≥ 18 years old
* Patient already deceased
* Available tumor tissue (FFPE block)

Exclusion Criteria:

Patient under 18 years of age
Bronchodilators and Respiratory Mechanics in Chronic Obstructive Pulmonary Disease (COPD) Patients

The aim of this study is to assess the effects on respiratory mechanics of one "classical" short-term bronchodilator (i.e., salbutamol) versus placebo, and to verify the hypothesis that the addition of another bronchodilator (i.e., anticholinergic) may induce a further improvement on the work of breathing of stable COPD patients.

Studies with long-acting b2-agonists in COPD patients who poorly respond to routine airways obstruction reversibility tests with forced expiratory manoeuvres, such as forced expiratory volume in one second (FEV1), are scarce. Such studies, however, seem to show favourable effects on clinical parameters.

This may explain the subjective improvements and changes in quality of life with long-acting b2-agonists in patients with COPD. The lack of effect on forced expiration tests may be due to early airway collapse and subsequent airflow decline causing underestimation of the existing bronchodilatory effects located more peripherally in the respiratory tract, where the major site of resistance is located in obstructive lung disease.

We therefore design a study aimed to assess the short term effects of one short-acting beta2-agonist vs placebo, and the effects of an additional and sequential administration of a different bronchodilator, like tiotropium bromide (anticholinergic agent) on the work of breathing, and its components (i.e., lung resistances and compliance) of COPD patients with poor reversibility assessed using the classical Pulmonary Function Tests.

Eligibility Criteria:
Inclusion Criteria:

* COPD patient with a Tiffenau ratio \<55% and \>25% predicted
* Poor reversibility to an acute bronchodilator test (i.e. FEV1 changes\<10% from baseline)

Exclusion Criteria:

* Lack of informed consent
* Cancer
* Concomitant lung and airways diseases
Serum Levels of Bupivacaine in Autotransfusion Drains Following Total Joint Arthroplasty

The purpose of this study is to quantify the total blood serum levels of bupivacaine in OrthoPAT® collected blood 2 hours and 5 hours postoperatively.

Hypothesis: Filtered blood from the OrthoPAT® autotransfusion system contains low or undetectable levels of bupivacaine hydrochloride (HCL). Reinfusion of collected blood from the OrthoPAT® device when used in conjunction with periarticular bupivicaine injections will not pose a bupivocaine toxicity risk to patients undergoing a total joint arthroplasty.

Total joint arthroplasty (TJA) is a commonly performed surgical procedure that can result in considerable postoperative pain which can limit social and functional recovery and a return to quality of life. Traditionally, pain control following TJA has been conducted with parenteral and oral narcotics. Recently, a number of studies have demonstrated the efficacy of multimodal analgesia following a variety of surgical procedures.1-2 These multimodal regimens vary and consist of any number of medications including narcotics, non-steroidal anti-inflammatories, anti-epileptics, and peripheral nerve blocks among others. These multimodal regimens have been associated with a reduction in the use of opioid analgesics, leading to fewer opioid-associated adverse events.3-5 One of the newest modalities introduced on the market is liposomal bupivacaine, trade name Exparel. The advertised advantage of liposomal bupivacaine compared with bupivacaine HCL is a longer duration of analgesia owing to gradual release from the liposomes. Liposomal bupivacaine is employed in a periarticular injection at the conclusion of TJAs to aid in post-operative pain control.

Patients receive a periarticular injection of liposomal bupivacaine intra-operatively during TJA. At the conclusion of the procedure, a specialized intra-articular drain (OrthoPAT®) is placed. The OrthoPAT® perioperative autotransfusion system collects the patient's blood in the immediate postoperative period and then allows for it to be transfused to the patient while on the floor.

A potential risk, although low, is the concern for bupivicaine toxicity. Toxicity from bupivicaine is associated with central nervous system issues (seizures) and cardiac toxicity. Toxicity is dose dependent and recommended levels should not exceed 400mg/24 hr period. With autotransfusion, there is a theoretical concern that blood, potentially with increased levels of bupivicaine, could be reinfused into the vascular system and create toxicity.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing primary total joint arthroplasty with use of periarticular bupivicaine and liposomal bupivicaine and OrthoPAT® auto reinfusion system.
* At least 18 years of age.

Exclusion Criteria:

* Allergy to bupivacaine.
* Allergy to epinephrine.
* Patients that are not presenting for a primary TJA
* Patients who are having a TJA without OrthoPAT® auto reinfusion system.
* Patients under age 18.
Working Memory Training in Adults With ADHD

The purpose of this study is to evaluate whether computerised working memory training improves cognitive performance, ADHD symptoms, psychosocial functioning and quality of life in adults with ADHD, from psychiatric outpatient clinics (N=100) as well as from a high-security prison facility (N=50).

The primary aim is to evaluate whether 5 weeks of computerised working memory training improves working memory capacity. Secondary aims are to explore whether improvements in working memory capacity will be transferred to improvements in learning abilities and fluid intelligence. Also, far transfer effects on executive functioning, ADHD symptoms, psychosocial functioning and quality of life will be explored. Finally, it will also be assessed to what extent improvements gained from 5 weeks of working memory training will be maintained 3 and 6 months post-study, respectively.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed ADHD according to DSM-IV criteria; ADHD combined type, ADHD inattentive type or ADHD UNS, primarily inattentive type.
* Unmedicated for ADHD during the course of the trial, or being under stable ADHD medication for at least one month at baseline visit and without any planned changes in medication until post-study assessments have taken place.

Exclusion Criteria:

* Previous participation in computerised working memory training (completed training).
* Any psychiatric disorder that in the judgment of the investigator, may interfere with study participation and/or study assessments, also including current substance abuse.
* Participation in psychological treatment addressing ADHD during the course of the 5-week training period (psychoeducation is accepted).
* Initiation of psychological treatment for coexistent disorders during the course of the study (treatment already ongoing at baseline visit is accepted if there are no planned changes during the 5-week training period).
Study of Anlotinib Hydrochloride Capsule Combined With Chemotherapy in Subjects With Squamous Non-small Cell Lung Cancer

Anlotinib hydrochloride is a multi-targeted receptor tyrosine kinase inhibitor that targets angiogenesis-related kinases such as VEGFR1/2/3, FGFR1/2/3, and other tumor-associated kinases involved in cell proliferation such as PDGFRα/β, c-Kit, and Ret have significant inhibitory activities.


Eligibility Criteria:
Inclusion Criteria:

1. Squamous non-small cell lung cancer.
2. A measurable lesion.
3. The disease progression occurs \>12 months after the end of the last treatment. 4.18-75 years old ; Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; Life expectancy ≥ 3 months.

5.Adequate laboratory indicators. 6.No pregnant or breastfeeding women, and a negative pregnancy test. 7.Understood and signed an informed consent form.

Exclusion Criteria:

1. The tumor invades the large blood vessels.
2. Central type squamous non-small cell lung cancer.
3. EGFR/ALK gene mutation is positive.
4. Has used EGFR inhibitors and ALK inhibitors.
5. Has other malignant tumors within 5 years.
6. Has a variety of factors affecting oral medications.
7. Symptomatic brain metastasis.
8. Uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage.
9. Spinal cord compression.
10. Has received radiotherapy, chemotherapy, surgery less than 4 weeks before randomization.
11. Severe allergies to therapeutic medications.
12. Adverse events caused by previous treatment did not recover to grade 1.
13. Has received major surgical treatment within 4 weeks before randomization.
14. Arteriovenous thrombosis occurred within 6 months.
15. Has drug abuse history that unable to abstain from or mental disorders.
16. Has severe or uncontrolled disease.
17. Participated in other clinical trials within 4 weeks.
18. According to the investigators' judgement.
A Study to Investigate Progression-Free Survival With Sonrotoclax Plus Obinutuzumab Or Sonrotoclax Plus Rituximab Compared With Venetoclax Plus Rituximab Treatment In Patients With Relapsed and/or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CELESTIAL-RRCLL)

The goal of this study is to compare how well sonrotoclax plus obinutuzumab works versus venetoclax plus rituximab in treating adults with relapsed and/or refractory (R/R) chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). The study will also compare how well sonrotoclax plus rituximab works versus venetoclax plus rituxumab in treating adults with R/R CLL/SLL. The safety of these treatments will also be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of CLL/SLL that meets the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria
* Received one or more prior therapies for CLL/SLL. For each line of therapy, participants must have received at least 2 cycles of the therapy
* Participants with prior BCL2i exposure are eligible if remission duration was ≥3 years with ≥2 years from last BCL2i intake
* Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1, or 2
* Adequate organ function

Exclusion Criteria:

* Known active prolymphocytic leukemia or currently suspected Richter's transformation
* Prior autologous stem cell transplantation or chimeric antigen receptor T-cell therapy within 3 months before first dose of study drug
* Prior allogeneic stem cell transplant with active graft-versus-host disease (GVHD), requiring immunosuppressive drugs for treatment of GVHD, or have taken calcineurin inhibitors within 4 weeks prior to consent
* Known central nervous system involvement by CLL/SLL
* Severe or debilitating pulmonary disease
* Clinically significant cardiovascular disease

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Bioactive Milk Peptides and Blood Pressure

The purpose of this study is to investigate the effects of bioactive milk peptides on blood pressure in mildly hypertensive subjects.


Eligibility Criteria:
Inclusion Criteria:

* age 30-60 years
* systolic blood pressure 140-160 mmHg and diastolic blood pressure 90-99 mmHg in office measurement
* apparently healthy

Exclusion Criteria:

* antihypertensive and lipid-lowering drugs
* unstable coronary artery disease, diabetes, malignant diseases, secondary hypertension
* BMI \> 32 kg/m2
* milk allergy
* smoking
* alcohol abuse
* pregnancy, lactation
* simultaneous participation in other clinical trial
Food Study of Valacyclovir Hydrochloride Tablets 1000 mg to Valtrex® Tablets 1000 mg

The objective of this study was to investigate the bioequivalence of Mylan's valacyclovir hydrochloride 1000 mg tablets to GlaxoSmithKline's Valtrex® 1000 mg tablets following a single, oral 1000 mg (1 x 1000 mg) dose administration under fed conditions.


Eligibility Criteria:
Inclusion Criteria:

* healthy, adult subjects, 18 years and older
* able to swallow medication

Exclusion Criteria:

* institutionalized subjects
* history of any significant disease
* use of any prescription or OTC medications within 14 days of start of study
* received any investigational products within 30 days prior to start of study
Study to Evaluate the Efficacy of YOUR SUPER Detox Bundle to Improve Perceived Well Being and Promote Adaptation of Healthy Dietary Choices

This is an open-label observational single-group clinical trial to study the efficacy of a commercial superfood blend and its effect on markers of well-being and improvement of long-term healthy eating habits.

This is an open-label observational single-group clinical trial to study the efficacy of a commercial superfood blend and its effect on markers of well-being and improvement of long-term healthy eating habits.

It is hypothesized that the dietary supplement marketed as Your Super Detox Bundle will improve subjective wellbeing and health in trial participants. It is further hypothesized that the accompanying diet plan will promote beneficial nutritional habits that may persist long term outside of the 5-day detox period. Additionally, the included food ingredients are reported to improve energy levels and sleep quality, while reducing unfavorable bloating, aches, and brain fog.

A total of 38 participants will be recruited for the trial following the screening. The trial will be fully remote, a technology platform will be utilized to screen, enroll and capture study data of the participants. Participants will undergo a 5-day detox period involving consuming two smoothies daily (for breakfast and dinner) containing variations of the Your Super Detox food powders as detailed below. Participants are encouraged to follow the provided plant-based nutritional plan for meals and snacks outside of the Your Super smoothie meals. Participant adherence to the provided nutritional plan is not mandatory, and lack of adherence by some participants will provide further data on the effect of the nutritional guidelines on the evaluated outcomes. After the 5-day detox period is completed, participants will be followed on for a subsequent 16 days to evaluate the effect of Your Super Detox bundle and guidelines to influence prolonged healthy eating habits.

Eligibility Criteria:
Inclusion Criteria:

* Male \& Female
* Age 18-55
* Feeling fatigued often
* Eating fast food, such as fries, burgers, pizza, chicken wings, etc. at least twice a week
* Does not exercise regularly
* Does not consume fruits and vegetables regularly
* Must be in generally good health - no unstable, uncontrolled health condition
* BMI under 40
* May feel bloated often
* May experience gas production often
* May experience heartburn
* May experience irritable bowel symptoms
* May experience irregular bowel movements
* May experience regular body aches
* May experience regular joint, back or neck pain
* Must have a body scale at home for regular weigh-in

Exclusion Criteria:

* Severe chronic conditions, including oncological and psychiatric disorders
* Known to have any severe allergic reactions
* Currently pregnant, breastfeeding, or wanting to become pregnant for the duration of the study
* Participants unwilling to follow the study protocol
Engaging Latino Families in Eating Disorders Treatment

Promoviendo Alimentacion Saludable (PAS)"Promoting Healthy Eating" is a research project funded by the National Institute of Mental Health. The purpose of this study is to develop and test a treatment for eating disorders in Latina adults that is appropriate for their age and includes culturally appropriate family intervention.

Research on culturally sensitive assessment and treatment of eating disorders among Latinos is scarce. This study is comparing individual Cognitive Behavioral Therapy (CBT) versus CBT with a family adjunctive intervention for eating disorders in Latina adults. All treatment will be conducted by trained professionals from either the UNC Eating Disorders Program (in Chapel Hill) or from El Futuro, Inc. (in Carrboro or Durham, NC) who have been trained in the treatment of eating disorders.

Participants will participate in 25, 50 minute-long, face-to-face CBT sessions over 27 weeks. Participants will be randomly placed in one of two groups: CBT or CBT with family enhancement. Those participants who are randomly placed into the CBT group will participate in 25 individual therapy sessions, 3 sessions with a dietitian, and psychiatry and/or medical assessments as needed. Those participants who have been randomly placed into the CBT with family enhancement group will participate in 19 individual therapy sessions, 6 family therapy sessions, 3 sessions with a dietitian, and psychiatry and/or medical assessments as needed. All participants will also be expected to participate in baseline, week 6 (mid-treatment), end of treatment, and 3-month follow-up assessments.

Eligibility Criteria:
Inclusion Criteria:

* DSM-IV criteria for BN, BED, EDNOS (sub-threshold BN)
* Latina
* If taking antidepressant medication, stable dose for at least 3 months prior
* Willingness to ask a family member or significant other to participate AND agreement of family member to participate

Exclusion Criteria:

* Any major medical condition that would interfere with treatment or require alternative treatment
* Alcohol or drug dependence in the last three months
* Current significant suicidal ideation
* Developmental disability that would impair the ability of the participant to benefit from psychotherapy effectively
* Psychosis, including schizophrenia, or bipolar I disorder
* Pregnancy
* Body mass index below 17.5 kg/m\^2
* If taking antidepressant medication, doses are not stable; individuals taking any medications that can significantly affect appetite or weight.
The Prognostic Value of Serum Biomarkers in Ewing's Sarcoma

Extraction of laboratory data from blood tests prior to surgical and chemotherapy and other histological, clinical and instrumental data related to the patient's history from the digitized medical Digitized medical records and analysis of the same. The medical records of 1000 patients from January 1, 2000, until December 31, 2020


Eligibility Criteria:
Inclusion Criteria:

* Patients with Ewing's Sarcoma and osteosarcoma with established diagnosis;
* Patients with age ≥ 2 years;
* Minimum follow-up duration of 2 years;
* Medical records, complete blood work and instrumental examinations; Regular follow-up.

Exclusion Criteria:

* Patients with Ewing's sarcoma or osteosarcoma who have received medical treatment (surgery radiotherapy or chemotherapy) in other institutions prior to admission to the Rizzoli Orthopaedic Institute.
Magnetic Resonance Elastography in Hydrocephalus

The purpose of this project is to assess the utility of a new magnetic resonance technique called magnetic resonance elastography (MRE) in the non-invasive diagnosis of normal pressure hydrocephalus. The investigators hypothesize that MRE produces a unique imaging signature for hydrocephalus that distinguishes the disease from the normal (non-hydrocephalic) but atrophied brain, a distinction not possible with conventional MR imaging studies that are presently available.


Eligibility Criteria:
Inclusion Criteria:

* Age \>21;
* One or more of the following complaints: memory loss/dementia, urinary incontinence, or progressive gait disturbance
* Ventriculomegaly defined as temporal horn width \>2 mm or a FH:ID ratio\>30% on computed tomography or MRI, where FH is the maximal distance between the frontal horns and ID is the internal diameter from inner table to inner table of the skull at this level (Greenberg)
* A diagnosis of any adult onset hydrocephalus (NPH, post-traumatic, post-hemorrhagic, obstructive, or idiopathic) will be considered for enrollment in this study

Exclusion Criteria:

* Implanted neuro-stimulator or cardiac pacemaker
* Known coagulopathy; major organ dysfunction
* End-stage congestive heart failure
* Oxygen-dependent pulmonary disease, hepatic cirrhosis, or dialysis- dependent renal failure; or other condition which, according to the assessment of the treating surgeon or anesthesia team
* Precludes consideration of elective surgery
* Patients who may be pregnant will be excluded from this study as well
Metformin as an Adjunctive Therapy to Catheter Ablation in Atrial Fibrillation

This clinical trial is being done to determine if metformin, a drug which is normally used in diabetes, can reduce atrial fibrillation in patients who are having an ablation for atrial fibrillation (AF). Atrial fibrillation is an abnormal heart rhythm which research has shown is related in part to obesity and diabetes.

It is anticipated that the participants treated in the metformin arm will have greater freedom from recurrent atrial arrhythmias after ablation.

Eligible participants enrolled in the trial will be assigned to one of the treatment arms (no treatment or metformin) and have follow-up visits up to approximately 1 year after the ablation. Additionally, all patients will also receive education on lifestyle changes and exercise which are standard of care.


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) \>25 kilograms / square meter (kg/m2) with plan for rhythm control of atrial fibrillation by catheter ablation
* All subjects must be able to understand and willing to sign a written informed consent document.

Exclusion Criteria:

* Individuals who are already taking metformin or other antidiabetic medications, including insulin
* Known diabetes
* Known allergy or Food and Drug Administration (FDA)-labeled contraindication to taking metformin (estimated glomerular filtration rate (eGFR)\<30 millilitres per minute (mL/min)/1.73 square meters (m2), hypersensitivity to metformin, acute or chronic metabolic acidosis)
* Patients taking carbonic anhydrase inhibitors
* eGFR below 30 mL/min per 1.73 m2 or other clinical diagnosis of advanced renal disease
* Acute or chronic metabolic acidosis (serum bicarbonate \<22 milliequivalents per liter (mEq/L))
* History of significant alcohol use (\>2 drinks/day on average)
* History of hepatic dysfunction (serum bilirubin 1.5 times greater than ULN)
* History of New York Heart Association (NYHA) Class III or IV heart failure
* Pregnancy or nursing
Decision Making in Hypothetical Carpal Tunnel Syndrome

Participants will be presented with a hypothetical scenario of carpal tunnel and asked to make a decision for that case.

Participants will be randomized into 1 of 2 groups and receive a hypothetical scenario of carpal tunnel, with or without cost information, and asked to decide if that hypothetical patient should undergo a carpal tunnel release.

Eligibility Criteria:
Inclusion Criteria:

* patients presenting to hand clinic OR mturk workers
* age 18 or older

Exclusion Criteria:

* traumatic mechanism of injury