cyrilzakka/clinical-trials huggingface dataset:
A Disease Registry of Patients With Mantle Cell Lymphoma

The purpose of this study is to create a patient registry in order to assess treatment patterns, physician reported clinical outcomes and patient-reported health-related quality of life among patients diagnosed with Mantle Cell Lymphoma (MCL) who newly initiated a novel therapy in the past 6 months and whose treatment is ongoing at the time of enrollment.

Newer targeted therapies (monotherapy or in combination with other agents) have been recently approved in the United States for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least 1 prior therapy. The approval of these newer therapies will have an impact on the treatment patterns, toxicity patterns, and outcomes in the MCL population. A prospective, observational study will help to better understand the evolving real-world treatment outcomes (including treatment patterns, reasons for discontinuation/dose reduction, treatment interruption or treatment switches), physician-reported clinical outcomes, and patient-reported symptoms and health-related quality of life (HRQoL) among patients diagnosed with Mantle Cell Lymphoma (MCL) who newly initiated a novel therapy in the past 6 months and whose treatment is ongoing at the time of enrollment.

Eligibility Criteria:
Inclusion Criteria:

* Patient diagnosed with Mantle Cell Lymphoma (MCL)
* Informed consent for participation
* Age ≥ 18 years old, as of the first observed diagnosis of MCL
* Patients for whom a clinical decision has been made to initiate novel therapy in the last 6 months, limited to the following novel agent categories:

  * Bcl-2 inhibitors
  * BTK inhibitors
  * Immunomodulatory agents
  * Phosphoinositide 3-kinase inhibitors The novel agent must have been granted approval in at least one haematological cancer. Treatment must be ongoing at the time of enrollment.

Exclusion Criteria:

• Patient is participating in a clinical study that prohibits participation in non-interventional studies, or where treatment is blinded, at the time of consent.
Collabree: A Remote Intervention to Improve the Regularity of Medication Intake

This is a clinical study to improve the regularity of medication intake for high blood pressure. Adult women and men who are over 50 years old, who have received a prescription drug for high blood pressure from MediService, and who have to take at least 4 tablets per day (of which at least 1 dose of medication per day is for high blood pressure) can participate in this study.

The investigators intend to examine whether Collabree, a mobile phone application, is effective in supporting patients with hypertension to more successfully following their therapy plan in order to improve the regularity of medication intake.

The study includes a 90-day intervention phase and a 90-day follow-up. The study does not require any therapy adjustments and no visits to a study center are necessary. The participants conduct the study independently at home. Participants will also fill out questionnaires.

Participants are randomly assigned to one of 3 groups in a ratio of 1: 1: 1. Two of these groups will receive the Collabree mobile phone application.


Eligibility Criteria:
Inclusion Criteria:

1. Informed consent as documented by signature.
2. Over 50 years of age on date of randomization.
3. Patient received prescription medicine against hypertension by post from MediService.
4. Prescribed a therapy against hypertension consisting of 4 or more tablets taken per day. At least 1 dose of medication per day must be against hypertension.
5. Participant administers their own medications.
6. Participant owns a smartphone with a data plan or constant internet access during the study reporting events and at home to use the application.
7. Minimal required smartphone operating system is iOS 12 and Android 8 (Oreo).
8. Adequate communication in German or Swiss-German (all study documentation will only be set to the German language).

Exclusion Criteria:

1. Inability to operate a mobile phone and the Collabree application.
2. Inability to follow the procedures of the study, e.g., due to language problems, psychological disorders, dementia, etc.
3. Enrollment of the Sponsor-Investigator, their family members, employees, and other dependent persons.
4. Participation in another interventional clinical trial.
Reversal Agent Use in Patients Treated With Direct Oral Anticoagulants or Vitamin K Antagonists

Patients treated with Vitamin K antagonists (VKA) or direct oral anticoagulants as Rivaroxaban, Apixaban, Edoxaban or Dabigatran, who experience severe bleeding and/or need urgent interventions/operations that cannot wait are included in this registry, or during emergency operations.

The Registry will offer the opportunity to evaluate the effects of reversal agents as PCC, aPCC, rVIIa, specific antidots in e.g. severe bleeding patients treated with oral anticoagulants.

By collecting case reports from several university hospitals and clinics, different treatment strategies in clinical practice will be observed and evaluated, and may serve as a comprehensive information resource for the safe management with DOA, but also with the long-term anticoagulation based on coumarin derivatives in the near future.

The current objective of this registry is to:

1. Document the clinical course and outcome of various clinical bleeding events associated with DOA or VKA in patients with severe life-threatening bleeding making intervention necessary
2. Document the clinical course and outcome of urgent surgical interventions within 24 hours after admission in patients under DOA or VKA treatment.
3. Characterisation of therapeutic strategies in stopping acute life-threatening bleeding including following agents and methods:

   1. blood transfusion,
   2. platelet concentrates
   3. reversal agents \[e.g. vitamin K, prothrombin complex concentrate (PCC), activated PCC (aPCC), activated factor VII (aVII), fibrinogen concentrate, fresh frozen plasma (FFP)\]
   4. specific antidots, e.g. idarucizumab
   5. haemodialysis
   6. desmopressin
   7. tranexamic acid
   8. no specific treatment in respect to the above mentioned treatments (e.g. stop of medication and waiting until anticoagulant effect of DOA is decreased).

Eligibility Criteria:
Patient Eligibility

1. a) Bleeding patients:

   Anticoagulated patients with DOA or VKA with clinically overt major bleeding according to a specified ISTH definition for non-surgical patients:
   * Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome
   * Bleeding causing a fall in hemoglobin level of 2 g L-1 (1.24 mmol L-1 ) or more leading to transfusion of two or more units of whole blood or red cells.

   OR b) Acute surgical need Patients treated with DOA or VKA and who need urgent operation which cannot wait (\< 24 h after last intake of drug)

   AND
2. with or without reversal agent use (e.g. PCC, aPCC, rVIIa) (and/or haemodialysis for dabigatran)

   AND
3. provides informed consent after the acute event
Trial of Endostar Combined With CHOPT for T Cell Lymphoma

To evaluate the efficacy and safety of Endostar combined with CHOPT in the treatment of T cell lymphoma.


Eligibility Criteria:
Inclusion Criteria:

1. Male and female aged 18 to 70 years old.
2. Diagnosis of T cell lymphoma according to WHO Classification, without antitumor therapy
3. At least 1 measurable tumor mass (greater than 1.5cm in the longest dimension and greater than 1.0 in the short axis)
4. Eastern Cooperative Oncology Group status 0-2
5. White blood cell≥4.0×109cells/L; Absolute neutrophil count (ANC) ≥1.5×109cells /L; Platelets≥100×109cells/L
6. Alanine transaminase (ALT) ≤2×upper limit of normal(ULN); Aspartate transaminase (AST) ≤2×ULN; Total Bilirubin≤1.5×ULN; Creatinine in normal range

Exclusion Criteria:

1. No active central nervous system lymphoma or brain tumor
2. Suppurative inflammation,Chronic infection
3. Severe heart disease, conclusion: congestive heart failure; uncontrolled cardiac arrhythmia; myocardial infarction; refractory hypertension
4. psychiatric history
5. Primary cutaneous T cell lymphoma
6. Pregnant or lactating women
7. Concurrent treatment with another investigational agent
8. Accept radiotherapy
Assessing the Clinical Outcomes of Dapagliflozin Versus Acetazolamide in Patients With Acute Heart Failure

This study investigates the comparative clinical outcomes of dapagliflozin, an SGLT-2 inhibitor, versus acetazolamide, a carbonic anhydrase inhibitor, in patients hospitalized with acute heart failure (AHF). The trial aims to assess the effectiveness of these drugs in improving natriuretic and diuretic responses and shortening hospital stays. Dapagliflozin and acetazolamide will be added to standard loop diuretic therapy, and their safety profiles will be evaluated to identify potential side effects. This research seeks to provide evidence for incorporating these drugs into AHF management, with the potential to improve clinical outcomes.


Eligibility Criteria:
Inclusion Criteria:

1. Adults aged 18 years or older who are hospitalized for hypervolemic AHF, with evidence of congestion defined as either:

   * 2 of the following signs or symptoms: peripheral edema, ascites, jugular venous pressure \> 10mmHg, orthopnea, paroxysmal nocturnal dyspnea, 5-pound weight gain, or signs of congestion on chest x-ray or lung ultrasound. OR
   * If pulmonary artery catheterization is available, a pulmonary capillary wedge pressure greater than 19 mmHg plus a systemic physical exam finding of hypervolemia from the list above.
2. Randomized within 24 hours of hospitalization for AHF.
3. Planned use of IV loop diuretic therapy during current hospitalization
4. Estimated glomerular filtration rate (eGFR) of at least 30 ml/min/1.73m2 by the MDRD equation.

Exclusion Criteria:

1. Unable to follow instructions.
2. Treated with any proximal tubular diuretics.
3. Systolic blood pressure of less than 90 mm Hg.
4. An estimated glomerular filtration rate (GFR) of less than 20 ml per 1.73 m2 of body-surface area.
5. Type 1 diabetes mellitus.
6. Dyspnea is primarily due to non-cardiac causes.
7. Cardiogenic shock.
8. Acute coronary syndrome within 30 days prior to randomization.
9. Planned or recent percutaneous or surgical coronary intervention within 30 days prior to randomization.
10. Signs of ketoacidosis and/or hyperosmolar hyperglycemic syndrome (pH\>7.30 and glucose \>15 mmol/L and HCO3\>18 mmol/L).
11. Pregnant or nursing (lactating) women.
Mini-laparotomy Versus Mini Lumbotomy

This study aims to compare the results of two mini invasive surgical approaches in abdominal aortic surgery: mini lumbotomy with retroperitoneal approach versus mini laparotomy with transperitoneal approach. Respiratory and renal functions and recovery of intestinal transit will be assessed after 30 days.

The secondary purpose of this study is to assess the life quality and morbi-mortality at 30 days, as well as at 6 and 12 months.

Following abdominal aortic surgery, post-operative outcomes are considered favorable with a rapid recovery of respiratory, renal functions and intestinal transit, with limited cardiac events. Complications are still frequent after the classic open abdominal surgery.

In abdominal aortic surgery, "mini" abdominal incision has been proposed as an alternative to the classic large surgical approach.

Two mini surgical approaches are possible: mini lumbotomy with retroperitoneal approach, and mini laparatomy with transperitoneal approach.

Previous studies have only compared classic versus mini surgical approaches and many are retrospectives studies. Pain control through the mini-incision surgery allowed early mobilization of patients, improved lung function, reduced muscle loss, and favoured intestinal motility.

So far, no study has compared the results of two mini invasive aortic approaches.

The aim of this prospective randomized study is to compare two mini-invasive surgical approaches and to determine which of them allows the improvement of surgical outcomes with less morbi-mortality.

Eligibility Criteria:
Inclusion Criteria:

* Elective abdominal aortic repair.
* Abdominal aneurysm or occlusive aortic disease requiring intervention.
* Written consent previously provided by the patient.
* Affiliation to social security.
* Preliminary medical examination.

Exclusion Criteria:

* Hostile abdomen.
* Juxta renal abdominal aortic aneurysm.
* Aneurysmal extension to the iliac arteries.
* Concomitant visceral arteries lesions.
* Urgent surgery.
* Contraindication to surgery.
The Efficacy of Single Coil Defibrillation Leads for Internal Cardioversion of Atrial Fibrillation

This study seeks to determine the efficacy of single coil defibrillation leads for cardioversion of persistent atrial fibrillation.

This study seeks to compare the efficacy of single coil defibrillation leads for the internal cardioversion of atrial fibrillation as compared with cardioversion by external defibrillation pads. It is known that dual coil leads are effective for atrial cardioversion, but the presence of the SVC defibrillation coil allows for selection of shock vector that more reliably incorporates the majority of atrial tissue compared to a single right ventricular lead. For a variety of reasons single coil defibrillation leads are now implanted in the majority of patients requiring placement of implantable cardiac defibrillators, and many of these patient's will later develop atrial fibrillation and potentially require cardioversion. Currently, there is no clear consensus on how to approach cardioversion in these patient's and both external and internal methods are used. Internal cardioversion may be ineffective exposing patient's unnecessarily to repeated shocks and battery depletion. External cardioversion may carry a small risk of damaged to the CIED.

The investigator's goal is to identify patient's referred for cardioversion for atrial fibrillation who also have an implanted cardiac defibrillator with a single coil defibrillation lead and randomize them to either external or internal cardioversion.

Eligibility Criteria:
Inclusion Criteria:

* greater than 18 years of age
* persistent atrial fibrillation and have been recommended by your primary cardiologist to undergo cardioversion
* have an implantable cardiac defibrillator

Exclusion Criteria:

* over the age of 99
* pregnant
* prisoner
To Demonstrate the Relative Bioavailability Study of Ondansetron HCl 24 mg Tablets Under Fasting Conditions

To demonstrate the relative bioavailability study of Ondansetron HCl 24 mg tablets under fasting conditions.


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria:

* Positive test results for HIV or hepatitis B or C.
* Treatment for drug or alcohol dependence.
Walnuts to Achieve Lasting NUTrition to Prevent Diabetes

Prediabetes is a precursor of type 2 diabetes and an independent risk factor for cardiovascular disease, and currently affects one-quarter of the population of the United States. Individuals of overweight or obese BMI are at particular high risk for incident diabetes. A major modifiable risk factor for type 2 diabetes is poor dietary quality, and improvement of dietary quality can effectively delay and even prevent type 2 diabetes. Interventions to improve dietary quality thus far, however, rely on short-term intensive clinically designed meals replacing the entire diet which have poor sustainability. Persistent improvements to daily dietary patterns are often difficult without directed guidance, and overall dietary quality in the United States remains poor. The identification of a practical, daily dietary intervention to improve dietary quality and prevent diabetes in those at high risk remains unknown. The investigators propose to enroll 40 individuals with diagnosed prediabetes into a randomized controlled pilot study and provide a daily walnut supplementation intervention to determine feasibility and acceptability of the supplement. The investigators will then determine preliminary efficacy on metabolic markers and will investigate associations between dietary quality and circulating levels of branched-chain amino acids. The goal is to implement a whole-food supplement to improve dietary quality in patients with prediabetes as a tool for future type 2 diabetes prevention.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female between 18-65 years of age at baseline living in the San Francisco Bay area.
2. BMI\>25 m/kg2 (or \>23 m/kg2 for individuals of Asian or South Asian ethnicity)
3. Documentation of prediabetes diagnosis as evidenced by the following criteria:

   1. A fasting glucose 100-125 mg/dL, or a HbA1c measurement of 5.7-6.4%, OR a diagnosis of "prediabetes" or "impaired fasting glucose" in the past 6 months, identified through an electronic medical record query from patients at UCSF and through outside recruitment in the surrounding community
   2. We will confirm eligibility of potential participants by repeating fasting capillary blood glucose measurements at the baseline visit to ensure that they have prediabetes
4. Written informed consent and ability for subject to comply with the requirements of the study.

Exclusion Criteria:

1. Pregnant or breastfeeding women at enrollment.
2. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data, such as diverticulosis or diverticulitis.
3. Tree or peanut allergies
4. Unwilling to consume a daily walnut supplement.
5. Diagnosis of diabetes
6. On glucose lowering medications
7. Dietician-managed dietary intake, or personal or medical dietary restrictions that do not allow consumption of walnuts
8. Malabsorptive conditions including intestinal bypass surgery, pancreatitis, inflammatory bowel disease
Effect of Topical Dexmedetomidine on Intraocular Pressure

Evaluate the short-term safety and efficacy of dexmedetomidine (0.0055%) drops on intraocular pressure (IOP) in healthy eyes.


Eligibility Criteria:
Inclusion Criteria:

* Patients with healthy eyes and no history of glaucoma

Exclusion Criteria:

* history of glaucoma, IOP \> 24mmHg at baseline, abnormal optic nerve on fundus examination, keratoconus, corneal graft, corneal edema or a history of refractive surgery
Effects of Teriparatide or Zoledronic Acid Treatment on Bone in Postmenopausal Osteoporotic Women

The purpose of this study is to investigate how teriparatide or zoledronic acid affects the bone of postmenopausal osteoporotic women after 6 months of treatment as determined by a bone biopsy sample taken from the iliac crest (upper part of the pelvis). After completing 12 months of treatment all participants are eligible to participate in an additional 12-month open label extension.


Eligibility Criteria:
Inclusion Criteria:

* Ambulatory, postmenopausal women with osteoporosis (no vaginal bleeding for at least 2 years prior to trial entry)
* Free of severe or chronically disabling conditions other than osteoporosis that will impair ability to complete the trial
* Bone mineral density (BMD) T-score of at least -2.5 at the femoral neck, total hip, or lumbar spine (L1-L4, with at least 2 evaluable vertebrae), with or without atraumatic fracture or,
* Bone mineral density (BMD) T-score of at least -1.5 at the femoral neck, or total hip, or lumbar spine (L1-L4, with at least 2 evaluable vertebrae), and either 1 or more atraumatic vertebral fracture(s) or an atraumatic nonvertebral fracture in the opinion of the investigator. Nonvertebral fracture sites allowed are wrist, hip, pelvis, ribs, humerus, clavicle, leg (femur, tibia, and fibula, excluding the ankle).
* Serum calcium, parathyroid hormone (PTH), alkaline phosphatase must be within normal reference range

Exclusion Criteria:

* Have an increased risk of osteosarcoma (bone tumor); this includes Paget's disease of bone, a previous bone tumor, or radiation involving the skeleton
* Are allergic or cannot tolerate teriparatide or zoledronic acid or any of their ingredients or components
* Are allergic to tetracycline
* Have a history of exposure to tetracycline therapy in the 3 months prior to trial entry
* Have participated in a prior PTH clinical trial or received prior treatment with teriparatide, PTH, or other related medications
* Have a vitamin D level below 10 nanogram/milliliter (ng/mL)
* Have a condition that could possibly put one at risk for an adverse event due to the bone biopsy procedure (e.g. bleeding disorder)
* Have undergone two previous iliac crest bone biopsies (one in each iliac crest)
* Have taken any intravenous (IV) osteoporosis medication
* Have taken other oral osteoporosis medications and have not been off of them for a specific period of time before trial entry
* Have a history of certain cancers in the 5 years prior to trial entry
* Have active liver disease
* Have significantly impaired kidney function
* Currently have active or suspected diseases that affect the bones, other than osteoporosis
* Have active or recent history of significant gastrointestinal (stomach or intestinal) disorders
* Have been treated with certain glucocorticoids for more than 30 days in the past 1 year prior to trial entry
Prediction of Extubation Failure: A Multicenter Prospective Observational Study

The investigators intend to collect several variables to predict extubation failure among patients who successfully complete a spontaneous breathing trial, and then develop a scale using simple bedside indicators to predict extubation failure.

Mechanically ventilated patients who successfully completed a spontaneous breathing trial and prepared for extubation are eligible to enroll in this study. The vital signs, arterial blood gas tests, cough strength, cuff leak test, use of noninvasive ventilation et al. are collected. Patients are followed up to postextubation 28-day or discharge. Extubation failure is defined as reintubatin or death within postextubation 7 days. First, we will analyze the data to predict extubation failure. Then, we will combine several easily obtained variables to develop and validate a scale to predict extubation failure. Finally, we explore the predictive power of extubation failure tested by the scale and find the cutoff value to distinguish the low, moderate and high risk of extubation failure.

Eligibility Criteria:
Inclusion Criteria:

* Prepared for extubation through spontaneous breathing trial;Oral or nasal endotracheal intubation; be at least 18 years old

Exclusion Criteria:

* Extubation without a spontaneous breathing trial ;Reintubation due to secondary surgery; Tracheotomy
Adherence, Efficacy and Tolerance of Once-a-day Nevirapine-based Regimen in HIV-1 Infected Patients

Taking antiretrovirals once-a-day is considered the simpler way to improve adherence. However, it is not know if this assertion apply to patients taking their medication twice-a-day who change to once-a-day.

We hypothesized that once-daily dosing improves adherence.


Eligibility Criteria:
Inclusion Criteria:

* HIV-1 infected adults receiving antiretroviral therapy including nevirapine twice-a-day for at least 6 months
* plasma HIV RNA\<400 cp/ml during the previous 4 months on 2 occasions
* accept adherence electronic monitoring
* written informed consent signed

Exclusion Criteria:

* asparate aminotransferase (AST) or alanine aminotransferase (ALT) \>2.5N if hepatitis virus B or C were negative
* AST or ALT\>1.25N if hepatitis virus B or C were positive