cyrilzakka/clinical-trials huggingface dataset:
Study of Coagulation Factor VIIa Variant Marzeptacog Alfa (Activated) in Adult Subjects With Hemophilia A and B

Phase 2, multi-center, open-label study designed to evaluate the PK, bioavailability, PD, efficacy and safety of a daily subcutaneous \[SC\] treatment regimen with MarzAA for bleeding prophylaxis in 12 adult subjects with hemophilia A or B with an inhibitor and history of frequent spontaneous bleeding episodes.

Multi-center, open-label Phase 2 study to evaluate the PK, bioavailability, PD, efficacy and safety of a daily SC treatment regimen with MarzAA for bleeding prophylaxis in adult subjects with hemophilia A or B with an inhibitor. The study will enroll and dose, both intravenously and subcutaneously, a total of 12 adult male subjects with severe congenital hemophilia A or B with an inhibitor, and history of frequent bleeding episodes during the 6 months prior to enrollment, as per the individual's bleeding and treatment records.

Once a subject is enrolled into the trial, the study will be conducted in three parts (occurring consecutively):

Part 1a (24 hours): Single IV administration of MarzAA; Part 1b (48 hours): Single SC administration of MarzAA; Part 2: Daily SC administration. Dose escalation in Part 2 will occur if breakthrough bleeding occurs. Subjects are treated for 50 days at the final dose level required.

Eligibility Criteria:
Inclusion Criteria:

* Severe congenital hemophilia A or B with an inhibitor.
* History of frequent spontaneous bleeding episodes.
* Male, age 18 or older.
* Affirmation of informed consent with signature confirmation before any trial-related activities.

Exclusion Criteria:

* Receiving prophylaxis treatment.
* Previous participation in a clinical trial evaluating a modified rFVIIa agent.
* Known positive antibody to FVII or FVIIa detected by central laboratory at screening.
* Have a coagulation disorder other than hemophilia A or B.
* Significant contraindication to participation.
Perioperative Recovery of Moods, Opioids, and Pain Trial (PROMPT)

The investigators aim to characterize the relationship between changes in emotional distress, opioid use, and pain throughout surgery and recovery. Additionally, the investigators aim to compare the effectiveness of post-surgical motivational interviewing and physician-guided opioid weaning vs. usual care on reducing persistent opioid use. Overall, the proposed research will advance knowledge regarding the role of psychological factors contributing to persistent opioid use after surgery.


Eligibility Criteria:
Inclusion Criteria:

* Age 18+
* Undergoing a scheduled surgery
* English speaking
* Ability and willingness to complete questionnaires and assessments.

Exclusion Criteria:

* Any conditions causing inability to complete baseline, telephone and internet assessments (e.g. education, cognitive ability, mental status, medical status)at the discretion of the investigator.
* Known Pregnancy
* Elevated Suicidality as assessed by an answer of 2 or greater on question 9 of the Beck Depression Inventory assessing suicidal thoughts.
* Coexisting Chronic Pain Disorder of moderate severity in area other than surgical target
A Study of CIN-107 in Patients With Uncontrolled Hypertension

This is a Phase 2, randomized, multicenter study to evaluate the efficacy and safety of multiple dose strengths of baxdrostat (also called CIN-107) in the treatment of patients with uncontrolled hypertension. The primary objective was to demonstrate that treatment with baxdrostat for 8 weeks would lower the systolic blood pressure (SBP) in patients who were hypertensive despite taking one or two anti-hypertensive medications.

Participants were assigned to take placebo or baxdrostat once per day for 8 weeks while they continued taking the regular anti-hypertensive medications. At the end of the 8-week period, qualified patients could participate in Part II of the study and receive 2 mg baxdrostat for 4 weeks while they discontinued taking the background anti-hypertensive medication.


Eligibility Criteria:
Inclusion Criteria:

* Is on a stable regimen of background antihypertensive agent(s) for at least 8 weeks and would be considered a candidate for an additional antihypertensive agent at the time of screening ;
* Has a mean seated systolic blood pressure (SBP) ≥ 140 mmHg or ≥ 130 mmHg if diabetic;
* Demonstrates ability to be adherent to the study drug and their anti-hypertensive medication during a run-in period
* If taking an SGLT2 inhibitor, the regimen must be stable for at least 8 weeks prior to randomization; and
* Agrees to comply with the contraception and reproduction restrictions of the study;

Exclusion Criteria:

* Has a mean seated systolic blood pressure (SBP) ≥180 mmHG;
* Has a body mass index (BMI) \>50 kg/m2;
* Is using alpha or beta blockers for any primary indication other than systemic hypertension (eg, migraine headache);
* Is not willing or not able to discontinue an MRA or potassium sparing diuretic as part of an existing antihypertensive regimen;
* Has documented estimated eGFR \<30 mL/min/1.73m2;
* Has known and documented New York Heart Association stage III or IV chronic heart failure;
* Has had a stroke, transient ischemic attack, hypertensive encephalopathy, acute coronary syndrome, or hospitalization for heart failure within 6 months before screening;
* Major cardiac surgery within 6 months before Screening;
* Has chronic permanent atrial fibrillation;
* Has uncontrolled diabetes with glycated hemoglobin \>10% at Screening;
* Has planned dialysis or kidney transplantation planned during the course of the study;
* Prior solid organ transplant and/or cell transplants;
* Sodium \<130 mEq/L;
* Potassium \<3.5 mEq/L;
* Potassium \>5 mEq/L;
* White blood cell count \>15 × E9/L or absolute neutrophil count \<1 × E9/L at Screening;
* Is positive for HIV antibody, hepatitis C virus RNA, or hepatitis B surface antigen;
* Has typical consumption of ≥14 alcoholic drinks weekly;
The Effect of Self-Acupressure on Pain and Sleep in Coronary Artery Patients

This study will be conducted to evaluate the effect of acupressure applied to patients with coronary artery disease (CAD) on pain and sleep quality.

Self-Acupressur application will improve pain and sleep quality in CAD.

Eligibility Criteria:
Inclusion Criteria:

* Not having a psychiatric diagnosis,
* To be able to communicate adequately
* Not having psychiatric problems
* Volunteering to participate in research

Exclusion Criteria:

* None
Urine Retention Rate Between Spinal and General Anesthesia for Anorectal Surgery

Anorectal surgery includes pilonidal sinus, hemorrhoidectomy, anal fissure, and anal fistula operations. General and spinal anesthesia were common anesthetic methods in anorectal surgery. We designed this study to test the hypothesis that general anesthesia was superior than spinal anesthesia with respect to urine retention rate, pain score, recovery time, and side effects.

Anorectal surgery includes pilonidal sinus, hemorrhoidectomy, anal fissure, and anal fistula operations. Deep level of anesthesia is required for these surgeries. Excellent operation conditions and rapid recovery is anticipated for optimal anesthesia. Various surgical and anesthetic techniques, including spinal anesthesia, general anesthesia and local infiltration have been used to increase the level of patients' perioperative analgesia and decrease the length of stay in the hospital. Among them, general and spinal anesthesia were common anesthetic methods in anorectal surgery. We designed this study to test the hypothesis that general anesthesia was superior than spinal anesthesia with respect to urine retention rate, pain score, recovery time, and side effects.

Inclusion Criteria:

* \>20 years old patients
* ASA 1-2 patients
* Patients who will undergo anorectal surgery with including hemorrhoidectomy, fistulectomy, fistulotomy, fissurectomy and anoplasty.

Exclusion Criteria:

* Having known hypersensitivity to amide type local anesthetics
* Patients ASA \>=3
* Surgery methods: hemorrhoidopexy, Laser hemorrhoidoplasty
* Fournier gangrene patients
* Surgery due to previous complications.

Characteristic data

1. Age, Gender, ASA class,
2. Past history: medical history, surgical history
3. Previous anorectal history
4. Type of anorectal surgery, number of hemorrhoidectomy
5. Methods of anesthesia, posture during surgery
6. Postoperative recovery room record: vital sign, Post Anaesthetic Discharge Scoring System (0-10, \>9 can discharge)
7. Ward record: vital sign and urine retention need foley catherization

Eligibility Criteria:
Inclusion Criteria:

* \>20 years old patients
* ASA 1-2 patients
* Patients who will undergo anorectal surgery with including hemorrhoidectomy, fistulectomy, fistulotomy, fissurectomy and anoplasty.

Exclusion Criteria:

* Having known hypersensitivity to amide type local anesthetics
* Patients ASA \>=3
* Surgery methods: hemorrhoidopexy, Laser hemorrhoidoplasty
* Fournier gangrene patients
* Surgery due to previous complications
Randomized Controlled Trial of urinE chemiStry Guided aCute heArt faiLure treATmEnt (ESCALATE)

This is a randomized trial of protocolized diuretic therapy guided by urinary sodium compared to structured usual care in ED patients with AHF. Participants will be recruited following an initial standard evaluation in the ED and randomized in a 1:1 fashion to structured usual care or protocolized diuretic therapy guided by urinary sodium.

A standardized protocol driven treatment pathway for hospitalized patients started in the first few hours of ED evaluation and utilizing objective measures of diuretic response is needed. The investigators believe this would maximize diuretic efficiency, facilitate quicker resolution of congestion, avoid WHF and prolonged LOS, and reduce AHF readmissions. Propr data suggests low urine sodium predicts length of stay and outcomes after initial diuretic dosing in the outpatient and inpatient setting. Further, use of our pathway using spot urine sodium to titrate subsequent loop diuretic doses and maximize response in inpatients with AHF has shown compelling improvements in congestion and weight loss. However, a randomized trial is necessary to determine if initiating this protocol ,started in the ED, will improve AHF outcomes relative to structured usual care. Specifically, the investigators hypothesize use of spot urine sodium guided diuretic therapy will result in significant improvement in days of benefit over the 14 days after randomization. Days of benefit combines patient symptoms captured by global clinical status with clinical state quantifying the need for hospitalization and IV diuresis.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18
* Emergency Department diagnosis of Acute Heart Failure (AHF)
* Any one of the following:

  i. Chest radiograph or lung ultrasound consistent with AHF ii. Jugular venous distension iii. Pulmonary rales on auscultation iv. Lower extremity edema v. S3 gallop
* \> 10 pounds of volume overload physician estimate or historical dry weight
* IV diuretic ordered or planned to be during first 24 hours of ED or inpatient stay

Exclusion Criteria:

* End Stage Renal Disease (ESRD) requiring dialysis
* Need for immediate intubation
* Acute Coronary Syndrome - presentation consistent with myocardial ischemia AND new ST-Segment elevation/depression
* Temperature \> 100.5ºF
* End Stage Heart Failure: transplant list or ventricular assist device
* Concurrent use of ototoxic medications including intravenous aminoglycosides and cisplatin
* Systolic Blood Pressure \< 90 mmHg at time of consent
* LV outflow obstruction, severe uncorrected stenotic valvular disease or severe restrictive cardiomyopathy
* Greater than 2 doses of IV diuretic administered at the time of screening from the time of the hospital presentation leading to this admission (outside hospital time is included)
* Severe, uncorrected serum electrolyte abnormalities at the time of consent (serum potassium \<3.0 mEq/L, magnesium \<1.0 mEq/L or sodium \<125 or \>150 mEq/l)
* Lack of informed consent
Framing Clinical Trial Enrollment for Patients With Peripheral Artery Disease

It is uncertain whether opt-out framing will increase participation in a clinical trial intended to promote physical activity in patients with peripheral artery disease (PAD). This study will test whether opt-in or opt-out framing of study participation upon initial contact affects the proportion of patients who ultimately enroll in the study and the demographic characteristics of enrolled patients.

The GAMEPAD study is a two-arm randomized controlled trial aimed at evaluating whether a home-based walking program with automated coaching augmented with gamification and behavioral economic principles improves functional capacity in patients with PAD. GAMEPAD will be conducted using the Way to Health platform, and patients will enroll and consent for participation online, with available help from a study coordinator by telephone. The present study will leverage the GAMEPAD enrollment process to test whether opt-in or opt-out framing of study participation upon initial contact affects the proportion of patients who ultimately enroll in the GAMEPAD study and the demographic characteristics of enrolled patients.

Eligible patients will be contacted via email to determine their interest in participation in the GAMEPAD study. Patients will be randomized 3:1 to an email message framing trial participation in a standard opt-in manner versus an email message framing trial participation in an opt-out manner.

Patients randomized to opt-in framing will be instructed to visit the Way to Health website to enroll in the GAME PAD study, or to call or email the study coordinator with questions or for assistance in enrolling. Patients randomized to opt-out framing will be informed that a study coordinator will be calling them in the coming days to discuss enrollment in the study.

Baseline characteristics of patients randomized to each framing method will be abstracted from the electronic health record and Penn Data Store, and will include age, sex, race/ethnicity, and medical comorbidities. Whether contacted patients created an account on the Way to Health website and/or ultimately consented for enrollment in the study will be captured.

For all outcomes, we will compare patients initially presented with study participation via opt-in framing versus opt-out framing. The primary outcome will be the proportion of patients that enroll in the GAMEPAD study. We will also report the proportion of enrolled patients that failed to complete the GAMEPAD study among those patients that ultimately enrolled.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Have been seen in the University of Pennsylvania Health System
* Have an ICD-10 code consistent with peripheral artery disease (I70.2x, I70.3x-I70.7x, I73.9) or peripheral artery disease on their problem list
* Have an email address on file with the University of Pennsylvania Health System

Exclusion Criteria:

* Previously indicated unwillingness to be contacted by email for participation in research studies
Bone Marrow Cells With Core Decompression for AVN Treatment

Avascular necrosis of the femoral head (AVN) is a progressive pathological process resulting from disruption of blood supply to the femoral head and elevation of intraosseous pressure. total hip arthroplasty is frequently the only durable option for pain relief and restoration of function. this is a single armed study to be done from July 2023 till January 2024, the total number of patients anticipated is 10, total joints treated around 20, The procedure includes core decompression with autologous bone marrow derived mononuclear cell injection inside the femoral head using local anesthesia ultrasound and fluoroscopy guided without drilling.

Avascular necrosis of the femoral head (AVN) is a progressive pathological process resulting from disruption of blood supply to the femoral head and elevation of intraosseous pressure. Early stage AVN can be managed by various techniques, the results have been disappointing, total hip arthroplasty is frequently the only durable option for pain relief and restoration of function. This procedure is usually a high risk procedure under general anesthesia ,with The newer treatment modalities include using high stem cell concentration in the vicinity of the necrosed tissue with core decompression to prevent disease progression. this study is a single armed study to be done from July 2023 to January 2024, the total number of patients is 10, Etiology include corticosteroids use, systemic lupus erythematosus mostly related to steroid use in covid 19 epidemic,. The age of the patients range from 25-55 years. The procedure includes core decompression with autologous bone marrow derived mononuclear cell injection inside the femoral head using local anesthesia ultrasound and fluoroscopy guided without drilling.

Eligibility Criteria:
Inclusion Criteria:

1. Avascular hip necrosis irrespective Of stage.
2. age from 25-55 years. -

Exclusion Criteria:

1. history of bleeding tendency.
2. history of malignant disease.
3. critically ill patient. -
Study of New Magnetic Resonance Methods

This study will evaluate new magnetic resonance imaging (MRI ) methods using a MRI machine more powerful than those in most hospitals. MRI is a diagnostic tool that uses a large magnet and radio waves to produce images of the human body. It can also provide information about brain chemistry and physiology. This study will use the new MRI hardware and methods to measure blood flow and metabolism in regions of the brain during simple tasks, such as listening to tones or watching flashing checkerboards.

Healthy normal volunteers will undergo MRI scanning. For this procedure, the person lies on a stretcher that is moved into a MRI machine, which produces a strong magnetic field. A special lightweight coil is placed on the person's head to obtain better pictures. The scan time ranges from 20 minutes to 2 hours, with the average scan lasting between 45 and 90 minutes.

During the MRI, the person may be asked to perform simple tasks, such as listening to tones or watching a screen, tapping fingers or moving a hand. More complex tasks may require thinking about tones or pictures and responding to them by pressing buttons.

The images produced in this study will be compared with those produced using standard MRI. The results will be used to develop improved imaging methods for better patient care and research.

Technical advances in Magnetic Resonance Imaging (MRI) and Magnetic Resonance Spectroscopy (MRS) has provided researchers with the opportunity to study functional and metabolic changes of the central nervous system (CNS) in both healthy controls and individuals with neurological diseases in response to sensory, motor or cognitive stimulation. While MRI is in common usage in radiology departments and clinics MRI and MRS techniques and hardware are continually being upgraded and designed for Functional Magnetic Resonance Imaging (fMRI) and Magnetic Resonance Spectroscopic Imaging of the CNS at 3.0 Tesla. We will evaluate new sequences on volunteers and for potential use in patients with CNS pathology. These studies are required in order to develop and implement new imaging techniques for research and clinical applications.

Eligibility Criteria:
* INCLUSION CRITERIA:

  1. age 18 and older
  2. capable of providing own informed consent
  3. capable of filling out MRI screening form

EXCLUSION CRITERIA:

1. contraindications for MRI including aneurysm clip; implanted neural stimulator; implanted cardiac pacemaker or auto-defibrillator; cochlear implant; ocular foreign body (e.g. metal shavings); or insulin pump, or other metal in the body.
2. pregnancy
3. Subjects will be excluded if it is deemed that they have a condition that would preclude their participation for technical development (e.g. claustrophobia)
4. Subjects will be excluded if they present unnecessary risk (e.g. Brain surgery of uncertain type, etc.).
Study of Surufatinib Combined With Sintilimab and SCRT in Advanced Solid Tumors

An exploratory clinical study of short course radiotherapy combined with surufatinib and sintilimab in the treatment of relapsed and refractory advanced solid tumors


Eligibility Criteria:
Inclusion Criteria:

1. Age 18-75 years (including 18 and 75 years), both genders;
2. Unresectable malignant tumors confirmed by histology or cytology (mainly biliary tract tumors, gastric cancer, small cell lung cancer, and other tumor types were included as appropriate), which failed at least after first-line standard treatment;
3. The lesions can be clearly evaluated by imaging;
4. Expected survival ≥ 12 weeks;
5. No serious abnormalities of blood system, heart, lung, liver, kidney function or immune deficiency;
6. Laboratory tests (without blood transfusion within 14 days) shall meet the following requirements:
7. If a fertile man or woman is willing to use contraception during the trial;
8. Physical status score ECOG 0-1;
9. Patients or their family members agreed to participate in the study and signed the informed consent form;

Exclusion Criteria:

1. Previous treatment with anti-VEGF/VEGFR-targeted drugs, such as surufatinib; Or previous treatment with anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs or another stimulatory or synergistic inhibition of T-cell receptors (including but not limited to CTLA-4, OX-40, LAG-3, CD137, etc.);
2. Women who are breast feeding, pregnant or preparing to become pregnant;
3. Corticosteroids (dose equivalent to prednisone \& GT; 10 mg/ day) or other immunosuppressive therapy;
4. Active, known or suspected autoimmune diseases or before 2 years of the history of the disease (in nearly 2 years can be treated as system of vitiligo, psoriasis, hair loss, or graves disease, need only thyroid hormone replacement therapy for hypothyroidism and only need insulin replacement therapy in patients with type 1 diabetes can group);
5. Allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation; Persons with HIV infection or active hepatitis b or c (active hepatitis b reference: HBV DNA≥1×104 copies /ml or ≥2000IU/ml; Active hepatitis C reference: HCV RNA≥1×103 copies /ml);
6. Interstitial lung disease (including past history and current condition), such as interstitial pneumonia, pulmonary fibrosis, or evidence of ILD on baseline chest CT or MRI;
7. Allergic constitution and multiple drug allergy;
8. Patients judged by other investigators to be unable to tolerate chemotherapy or not suitable for inclusion.