cyrilzakka/clinical-trials huggingface dataset:
a Study to Evaluate the Safety and Efficacy of D-1553 Combined With IN10018 in KRAS G12C Mutant Solid Tumors

This is a phase 1b/II, open-label study to evaluate the safety, tolerability, pharmacokinetics and antitumor activities of D-1553 in combination with IN10018 in subjects with locally advanced or metastatic solid tumor with KRAS G12C mutation.

This study includes 2 phases: Phase Ib-Dose Escalation and Phase II-Dose Expansion. Phase Ib-Dose Escalation part will enroll at least 6 subjects to identify the safety and RP2D of D1553 in combination with IN10018 in KRAS G12C mutant solid tumors. Phase II-Dose Expansion part contains 3 cohorts with cohort A to enroll advanced colorectal cancer (CRC) with KRAS G12C mutation, cohort B to enroll advanced non-small cell lung cancer (NSCLC) with KRAS G12C mutation, and cohort C to enroll other advanced solid tumors with KRAS G12C mutation. Phase II study is to evaluate the safety and antitumor activities of D-1553 in combination with IN10018 in KRAS G12C mutant solid tumors. The sample size in each cohort is estimated per Simon's 2-stage design. In Cohort A, when Simon's 2-stage study achieved statistical hypothesis, an open-label, randomized study will be conducted for factorial analysis to evaluate the contribution of IN10018 in the combination regimen.

Eligibility Criteria:
Inclusion Criteria:

1. Men or women aged ≥ 18 years at the time of signing the informed consent form.
2. Subjects with pathologically confirmed locally advanced or metastatic solid tumors.
3. Confirmed positive KRAS G12C mutation in tumor tissue or other biospecimens (only for phase1b) containing cancer cells or DNA.
4. Tumor types in different phases and cohorts: 1) Phase 1b: subjects with locally advanced or metastatic solid tumors who have progressed on or failed in standard therapy, and no standard treatment is available. 2) Phase II Cohort A: subjects with locally advanced or metastatic CRC. 3) Phase II Cohort B: subjects with locally advanced or metastatic NSCLC. 4) Phase 2 Cohort C: subjects with other locally advanced or metastatic solid tumors.
5. Has measurable lesions at baseline according to RECIST 1.1 criteria.
6. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
7. Adequate bone marrow, liver, renal, and coagulation function within 7 days prior to the first dose.

Exclusion Criteria:

1. Prior KRAS G12C inhibitors treatment.
2. Have known symptoms of spinal cord compression, instable or symptomatic central nervous system (CNS) metastases, and/or carcinomatous meningitis.
3. Have a history of stroke or other serious cerebrovascular diseases within 12 months prior to the first dose.
4. Have had interstitial lung disease or any active infection requiring systemic treatment within 14 days prior to the first dose.
5. Has a history of severe cardiovascular disease such as acute myocardial infarction, severe/unstable angina, QTc prolongation, or poorly controlled hypertension.
6. Haven't recovered from toxicity due to prior antitumor therapy
7. Pregnant or lactating women.
8. Malignant neoplasms other than study disease within 5 years prior to enrollment.
Cefixime Versus Benzathine Penicillin G in Treatment of Early Syphilis

This study evaluates the efficacy (non-inferiority) and safety of a new antibiotic treatment (cefixime), which has been previously used for single dose therapy of gonorrhoea in many years , in the treatment of early syphilis. Participants will be randomized to one of two study arms and will receive either expirimental regimen (cefixime) or the current standard antibiotic regimen (benzathine penicillin G). New treatment alternatives for syphilis could ensure that people are appropriately treated during periods or in settings of benzathine penicillin G stock out, penicillin allergy, or other intolerance to penicillin injection. This study may also identify an oral regimen for settings in which injections are not feasible.


Eligibility Criteria:
Inclusion Criteria:

1. 18 years of age or older
2. Non-pregnant, non breastfeeding
3. Able to provide informed consent
4. Clinically or laboratory-confirmed primary, secondary or early latent syphilis with a positive rapid treponemal test and an RPR/VDRL titer equal to or greater than 1:8
5. Non-cephalosporin allergic
6. Non-penicillin allergic
7. Agree to be occasionally called by study staff to be reminded to take study drug
8. Willing to attend follow-up visits

Exclusion Criteria:

1. Under 18 years of age
2. Pregnancy, breastfeeding
3. Prior history of syphilis in last two years
4. Allergy or contraindication to penicillin or cephalosporins (including allergy to cefixime)
5. Systemic antibiotic therapy in last two weeks
6. Previous enrollment in the study
7. Presenting a situation or condition that would not allow reliable study follow up (For example: frequent travel, alcohol abuse or substance misuse)
Distal Versus Conventional Transradial Artery Access for Coronary Catheterization in Patients With STEMI

Recently, a novel distal transradial, through anatomical snuffbox, approach has been proposed for undertaking percutaneous coronary angiography and interventions. The existing literature has evaluated distal transradial access (dTRA) as a feasible and safe approach, with faster hemostasis, lower rates of periprocedural complications and reduced incidence of radial artery occlusion (RAO). Aim of the present study is to compare dTRA versus conventional TRA access in patients with STEMI undergoing coronary angiography and interventions regarding peri- and post-procedural characteristics.

Gaining vascular access is the first, mandatory step for undertaking percutaneous coronary angiography and interventions. The recent guidelines, published by European Society of Cardiology (ESC), American College of Cardiology (ACC), American Heart Association (AHA) and Society for Cardiovascular Angiography and Interventions (SCAI), propose TRA as the gold standard for acute coronary syndromes (ACS), chronic coronary syndrome (CCS) percutaneous coronary interventions (PCI). Recently, a novel distal transradial, through anatomical snuffbox, approach has been proposed. The existing literature has evaluated distal transradial access (dTRA) as a feasible and safe approach, with faster hemostasis, lower rates of periprocedural complications and reduced incidence of radial artery occlusion (RAO). Mutual point of all the previous RCTs is that excluded patients suffering from ST-elevation Myocardial Infraction (STEMI). Aim of the present study is to compare dTRA versus conventional TRA access in patients with STEMI undergoing coronary angiography and interventions regarding peri- and post-procedural characteristics.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years old
* Indication: ST-Elevation Myocardial Infraction

Exclusion Criteria:

* Non-palpable radial artery
* Previous CABG
* Anatomical restrictions for forearm approach
* Hemodynamic instability
* Previous radial artery catheterization from the same arm during the last 30-days
Beetroot Juice and Sleep

The purpose of this study is to investigate the effects of acute inorganic nitrate supplementation (with beetroot) on the regulation of sleep and neurovascular physiology.


Eligibility Criteria:
Inclusion Criteria:

* 18-35 or 65-80 years of age

Exclusion Criteria:

* Coronary artery disease
* Heart failure
* Pregnancy
* Diabetes
* Sleep disorders
* Shift workers
* Individuals who typically go to sleep after midnight
* Individuals who traveled across ≥2 time zones within one week of study visits
* Individuals with a history frequent kidney stones
* BMI ≥35.0kg/m2
* Use of nicotine-containing products within the two years preceding study visits
* Use of allopurinol, proton pump inhibitors, or other medications/supplements which interfere with the nitrate-nitrite-nitric oxide pathway or outcome measures
An Extension Study to Evaluate Casimersen or Golodirsen in Patients With Duchenne Muscular Dystrophy

The main objective of this study is to evaluate the safety and tolerability of long-term treatment with casimersen or golodirsen in patients with Duchenne muscular dystrophy (DMD).


Eligibility Criteria:
Inclusion Criteria:

* Completed a clinical trial evaluating casimersen or golodirsen, per protocol.
* Is between 7 and 23 years of age, inclusive, at enrollment.

Other inclusion/exclusion criteria apply.
Epidural Hydromorphone Compared With Hydromorphone Infusion in Treating Patients With Prostate Cancer Undergoing Radical Prostatectomy

RATIONALE: Giving hydromorphone in different ways may relieve the pain associated with cancer surgery.

PURPOSE: Randomized double-blinded phase III trial to compare the effectiveness of epidural hydromorphone with hydromorphone infusion in patients with prostate cancer undergoing radical prostatectomy.

OBJECTIVES: I. Define the duration of action of hydromorphone (spinal vs supraspinal) in patients who have undergone radical prostatectomy. II. Demonstrate that the duration of the analgesic effects of equal blood concentrations of hydromorphone is dependent on the method used to attain this concentration by comparing continuous epidural infusion with that of a continuous intravenous infusion.

OUTLINE: This is a double blinded, randomized study. After all patients have undergone radical prostatectomy, hydromorphone is administered in two different ways. Patients receive either a hydromorphone bolus injection through an epidural catheter using a patient controlled analgesia pump or a hydromorphone bolus injection through an intravenous catheter using a patient controlled analgesia pump. Infusion for both groups is stopped at 24 hours. Patients are followed every 30 minutes for 6 hours.

PROJECTED ACCRUAL: A total of 40 patients will be accrued into this study over a 3 year period.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed prostate cancer Not metastatic Must be undergoing radical prostatectomy

PATIENT CHARACTERISTICS: Age: 18-70 Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Neurologic: No presence of an intracranial lesion associated with increased intracranial pressure Pulmonary: No chronic obstructive pulmonary disease No cor pulmonale No emphysema No kyphoscoliosis No status asthmaticus Other: No contraindications for the insertion of epidural catheter No known hypersensitivity to hydromorphone No history of alcoholism, drug abuse, mental dysfunction, or cognitive deficiencies

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified for prior surgery(ies) Other: No preoperative opioids for any reason
Peripheral Blood Stem Cell Transplantation From Family Haploidentical Donors in Patients With Myelodysplastic Syndrome and Acute Leukemia Under Primary Prophylaxis With Posaconazole

SIR-POSA is a phase II trial of peripheral blood stem cell (PBSC) transplantation from a partially compatible family (Haplo) donor in patients with a blood tumor (myelodysplastic syndrome (MDS) and acute leukemia) treated for the prevention of primary fungal infections with posaconazole.

The aim is evaluate the composite end-point graft-versus-host disease-free, relapse-free survival (GRFS) in these patients and evaluate the feasibility and efficacy of posaconazole oral tablets as primary antifungal prophylaxis.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of myelodysplastic syndromes or acute leukemia
* Activation of an alternative donor search by the Italian Bone Marrow Donor Registry (IBMDR) with absence of a 10/10 Human Leukocyte Antigens (HLA) matched unrelated donor
* Age \>18
* Unavailability of a HLA-matched related donor (MRD)
* Performance status : Eastern Cooperative Oncology Group (ECOG) \<3
* Written and signed informed consent
* Life expectancy not severely limited by concomitant illness.

Exclusion Criteria:

* Women of child-bearing potential who do not agree to abstinence or, if sexually active, do not agree to the use of highly effective method of birth control such as condoms, implants, injectables, combined oral contraceptives, intrauterine devices (IUDs), vasectomised partner on treatment and for at least 6 months thereafter.
* Pregnant or nursing (lactating) women.
* Known allergies, hypersensitivity, or intolerance to any experimental drugs.
* Any active, uncontrolled infection.
Prospective Cohort Study for Analyzing the Effect of Gastric Cancer Surgery to the Metabolic Syndrome and Insulin Resistance

Gastric cancer is still one of the most common malignance in Korea. Because of the popularity of regular check ups, early detection of gastric cancer has increased, consequently, the survival of the patients also has increased. In this reason, the interest of outcomes after gastrectomy for gastric cancer move survival only to quality of life of these patients.

Although the definition of metabolic syndrome is various, but it is normally accepted as a state that insulin resistance or glucose intolerance combined with hypertension or hyperlipidemia or obesity. Metabolic syndrome is a worldwide health problem, and the treatment is modification of life style, weight loss and medication. However, in most of the patients metabolic syndrome is considered not curable disease. Recent studies have shown that some bariatric surgery offers not only control the overweight but also metabolic syndrome. The exact mechanism is still unknown but decreased gastric volume and intestinal bypass itself seemed to play an important role to improve metabolic syndrome over just decreased weight.

For treating gastric cancer, gastrectomy is essential and the extent of gastrectomy is varied subtotal and total gastrectomy according to the location of tumor. Also, reconstruction type is varied gastroduodenostomy and Roux-en-Y gastrojejunostomy after subtotal gastrectomy, esophagojejunostomy after total gastrectomy. This kind of operation for gastric cancer lead decreased gastric volume and/or intestinal bypass, which means this operation could lead similar effect of bariatric surgery. Already, there have been several retrospective reports that metabolic syndrome or diabetes was improved after gastrectomy for gastric cancer but no prospective study about this subject yet in Korea.

The purpose of this study is that evaluating the degree of improvement of metabolic syndrome after gastrectomy for gastric cancer, and analyze the differences between the type of operation.


Eligibility Criteria:
Inclusion Criteria:

1. gastric cancer,
2. in plan for gastrectomy for gastric cancer
3. ages between 20 to 85 years old
4. assign in consent

Exclusion Criteria:

1. vulnerable subject (pregnant, be devoid of mental capacity, soldiers, or medical students)
2. had low performance scale due to severe cardiovascular disease.
Phase III Randomized, Double-Blind, Placebo-Controlled Study of Intravenous Immune Globulin for Chronic Inflammatory Demyelinating Polyneuropathy

OBJECTIVES:

I. Compare the response of previously untreated patients with chronic inflammatory demyelinating polyneuropathy to intravenous immune globulin vs. placebo.

PROTOCOL OUTLINE: This is a randomized, double-blind study. The first group receives intravenous immune globulin (IVIG) on days 1, 2, and 21; the second group receives an intravenous placebo on the same schedule.

Patients in either group may receive IVIG (same dosage as first group) after day 42.

Concurrent steroids and other immune globulin preparations are prohibited.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Chronic inflammatory demyelinating polyneuropathy (CIDP), i.e.: Progressive or relapsing motor and sensory dysfunction of more than 1 limb over at least 2 months Hypo- or areflexia of at least 2 limbs No myelopathy No central demyelination No drug or toxic exposure known to cause peripheral neuropathy --Prior/Concurrent Therapy-- No prior corticosteroids or other immunomodulators for CIDP No prior plasmapheresis At least 30 days since participation in other investigational study At least 6 months since the following: Cyclophosphamide Intravenous immune globulin Cyclosporine Interferon alfa Azathioprine Corticosteroids Orthoclone Tacrolimus --Patient Characteristics-- Hepatic: No hepatitis Renal: Not specified Neurologic: Cerebrospinal fluid (CSF) protein greater than 50 mg/dL CSF cell count less than 10 CSF VDRL negative 3 of the following motor abnormalities by electrophysiology: Reduced conduction velocity in 2 or more motor nerves Less than 80% of normal if amplitude greater than 80% of normal Less than 70% of normal if amplitude less than 80% of normal Conduction block or abnormal temporal dispersion in 1 motor nerve No ulnar or peroneal nerve entrapment Prolonged distal latency in 2 or more nerves Greater than 125% of normal if amplitude greater than 80% of normal Greater than 150% of normal if amplitude less than 80% of normal Absent F-waves or H response (patients aged under 60) or prolonged shortest F-wave latency in 10 to 15 trials in 2 or more motor nerves Other: No hypersensitivity to immune globulin No IgA deficiency No mutilation of hands or feet No retinitis pigmentosa No ichthyosis No disease that would limit neuromuscular assessment No endocrinopathy No connective tissue disease or vasculitis No Lyme disease No malignancy No Castleman's disease No hyper- or hypothyroidism No HIV infection No alcohol or drug abuse No pregnant or nursing women
Study to Compare Suture Material in Closure of Uterine Incision in Cesarian Section

Prospective single blinded trial comparing standard synthetic suture material to a synthetic barbed suture in closure of uterine incision, during Cesarean section procedures.

Cesarean section is one of the most common medical procedures women of child bearing age undergo, in the United States and the world. This trial is designed to provide information and possible recommendation as to suture material used during closure of the uterus during that procedure. Our intent is to provide data relating to time of uterine closure, blood loss, and post operative pain. These conclusions may provide substantiated recommendations as to self locking and tying suture material in the performance of cesarean section as related to readily available synthetic suture material, which has the need for standard suture knot placement.

Eligibility Criteria:
Inclusion Criteria:

* Women of childbearing age undergoing primary or repeat cesarean section using regional anesthesia.

Exclusion Criteria:

* General Anesthesia
* Non-consent to participation
Testing a Gender-inclusive HIV Prevention Program

If, over time, data suggest the intervention impacts HIV preventive behavior at the population level, it will be unique in that it can be quickly and cost effectively scaled up to impact thousands of trans girls and nonbinary youth assigned male at birth.


Eligibility Criteria:
Inclusion Criteria:

1. assigned male sex at birth and currently have a non-cisgender identity (e.g., transgender girl, non-binary, gender fluid, unsure);
2. aged 14-18 years and have not yet graduated high school;
3. English-speaking;
4. the sole user of a cell phone with an unlimited text messaging plan;
5. have access to the Internet to complete online surveys;
6. intend to have the same cell number for the next 6 months;
7. provide informed assent;
8. not have taken part in a previous #TranscendentHealth study activity or know someone who is in the study to increase the diversity of input from transgirls, and
9. agree to enroll over the phone with study staff.

Exclusion Criteria:

* None beyond not meeting inclusion criteria
Myocardial Effects of NIV in OHS Patients

Chronic effects of noninvasive ventilation on myocardial function in patients with obesity hypoventilation syndrome (OHS) are scarcely understood. The aim of the present study was to evaluate the long-term effects of volume-targeted bilevel-positive airway pressure ventilation (BiPAP) on cardiac parameters and myocardial biomarkers in patients with OHS.

Chronic effects of non- invasive ventilation on myocardial function in patients with obesity hypoventilation syndrome (OHS) are scarcely understood. The aim of the present study was to evaluate the long-term effects of volume-targeted bilevel-positive airway pressure ventilation (BiPAP) on cardiac parameters and myocardial biomarkers in patients with OHS. Clinically stable patients with OHS referred to the tertiary centre for the initiation of long-term BiPAP therapy were consecutively enrolled in the study. At baseline, all participants underwent overnight cardiorespiratory polygraphy. BiPAP therapy using volume-targeted spontaneous/timed mode delivered via an oro-nasal mask was initiated. Beat-to-beat noninvasive monitoring by impedance cardiography was used to assess heart function at baseline and after 3 and 12 months of BiPAP use. Serum troponin 1, N-Terminal Pro-B-Type Natriuretic Peptide (NTProBNP), tumor necrosis factor-alpha (TNF-α), and interleukin-6 (IL-6) were monitored. Potential risks and benefits comprise haemodynamic effects of NIV on cardiovascular parameters including cardiac output and stroke volume. The study started 06/2016 and enrolment was finalized in October 2018. The study was funded by grants from the Slovak Research and Development Agency under contract No. APVV-16-0158, and VEGA 1/0220/17 and 1/0393/22 of the Ministry of Education, Slovakia. The main investigator is Pavol Pobeha, MD, PhD, co author is Ivana Paranicova, MD, PhD and the corresponding author (study coordinator prof. Ruzena Tkacova, MD, PhD)

Eligibility Criteria:
Inclusion Criteria:

- Clinically stable patients with OHS and chronic severe hypercapnia

Exclusion Criteria:

* inability to provide written informed consent
* neuromuscular diseases
* chest wall diseases
* metabolic diseases
* acute respiratory tract infection
* chronic obstructive pulmonary disease (COPD)
* systolic LV failure as evidenced by LV ejection fraction\<45% on echocardiography