cyrilzakka/clinical-trials huggingface dataset:
Combination Chemotherapy Followed by Surgery in Treating Patients With Stomach Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and combining chemotherapy with surgery may kill more tumor cells.

PURPOSE: This phase II trial is studying how well irinotecan and cisplatin followed by surgery, floxuridine, and cisplatin work in treating patients with stomach cancer.

OBJECTIVES:

* Determine the complete and partial response rates and time to treatment failure in patients with advanced gastric cancer treated with neoadjuvant irinotecan and cisplatin followed by surgery then intraperitoneal floxuridine and cisplatin.
* Determine the rate of potentially curative surgery in patients receiving this regimen.
* Determine the toxicity and tolerance of this regimen in these patients.

OUTLINE: Patients receive cisplatin IV and irinotecan IV once a week for 4 weeks. This course is repeated 2 weeks later.

Patients who achieve complete or partial remission or stable disease undergo resection 4 weeks after the last chemotherapy dose.

Patients with no residual macroscopic disease begin adjuvant intraperitoneal (IP) chemotherapy 1 week after surgery. Chemotherapy consists of floxuridine IP over 30 minutes on days 1-3 and days 22-24 and cisplatin IP on days 3 and 24.

PROJECTED ACCRUAL: A total of 18-33 patients will be accrued for this study within 2 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically proven, previously untreated gastric cancer

  * Stage IB, II, III, or IV (T3-4, N0 OR any T, N1-2, M0)
  * No metastases

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* SWOG 0-2

Life expectancy:

* Not specified

Hematopoietic:

* WBC at least 4000/mm\^3
* Platelet count at least 100,000/mm\^3
* Hemoglobin at least 9 g/dL

Hepatic:

* Bilirubin less than 2 mg/dL
* SGOT/SGPT no greater than 2 times upper limit of normal (ULN)
* Alkaline phosphatase no greater than 3 times ULN
* PT, aPTT, and TT normal
* No Gilbert's disease

Renal:

* BUN no greater than 30 mg/dL
* Creatinine no greater than 1.5 mg/dL OR
* Creatinine clearance greater than 60 mL/min

Cardiovascular:

* No myocardial infarction within the past 3 months
* No congestive heart failure requiring therapy

Other:

* No other invasive malignancy in the past 5 years except adequately treated basal or squamous cell skin cancer or carcinoma in situ of the cervix
* No active or uncontrolled infection
* HIV negative
* No other severe concurrent disease
* No psychiatric disorders that would preclude compliance
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* No prior chemotherapy for gastric cancer

Endocrine therapy:

* Not specified

Radiotherapy:

* No prior radiotherapy for gastric cancer

Surgery:

* No prior surgery for gastric cancer
* No emergent need for surgery for gastrointestinal obstruction, perforation, or hemorrhage
Ohio State University Multiple Myeloma and Amyloidosis Data Registry and Sample Resource

The investigators are researching patients with diseases of their plasma cells in order to improve their quality and length of life. The investigators have created a database of patient information, blood samples, and bone marrow tissue in order to achieve the following three goals:

* Surveillance: The investigators want to track what treatments patients get or don't get, how effective they are, how they feel, what complications they suffer, how long they stay in remission, and how long they live.
* Contact: Because myeloma and amyloidosis are rare, less than 700 patients are diagnosed in the state of Ohio each year, patients often feel they don't have accurate information. The investigators want to provide them access to our clinical team (both phone and email consultations, even office visits for patients that can come to Columbus) as well as information regarding informational events pertaining to your disease and local support groups.
* Research: Because nearly all myeloma and amyloid patients relapse and treatment is eventually unsuccessful, our focus is to develop more effective treatments that not only prolong life, but cure the disease. Periodically the investigators will inform them about clinical trials studying new drugs or treatment paradigms.

The investigators propose to contact and interact with all patients with plasma cell dyscrasias in the State of Ohio (and all patients diagnosed or treated at Ohio State Medical Center) for both surveillance and research purposes in order to develop interventions targeted to decrease their morbidity and mortality.

Eligibility Criteria:
Inclusion:

Diagnosis of a plasma cell dyscrasia

Exclusion:

Prisoners are excluded from participation as they have no standard access to the Ohio State myeloma clinic and would impede the research objective of this protocol.
A Randomized, Open-Label, Multi-Center Study To Evaluate The Efficacy And Safety Of Intramuscular Ziprasidone In Patients With Agitation

This local registration study is to confirm the hypothesis of the efficacy, tolerability and safety of ziprasidone IM (intramuscular) in the Chinese population with agitation in schizophrenia


Eligibility Criteria:
Inclusion Criteria:

* Male or female Chinese subjects aged 18-65 years (including 65) at screening.
* Subjects meeting the ICD-10 (Classification of Mental and Behavioral Disorders) criteria for schizophrenia (F20.X).
* Subjects who are in acute phase of schizophrenia and are appropriate to receive intramuscular medication for at least 3 days

Exclusion Criteria:

* History of clinically significant physical illness especially myocardial infarction, non compensatory heart failure etc.
* Subjects receiving an investigational agent in the previous 3 months prior to screening.
* Use of antipsychotic agents within 12 hours or parenteral benzodiazepines within 4 hours prior to randomization and during the study.
Reducing Transition Drug Risk

Patient transfer between sites of care is regular practice during an episode of care in our current health care system. Yet inter-site transfer is associated with lapses in care quality that adversely affect patient outcomes. A common iatrogenic harm precipitated at the time of transfer is harm from drug prescribing, or adverse drug events (ADEs). In this study we will evaluate a medication reconciliation tool developed to help providers make effective prescribing decisions at the time of transfer between VA sites of care (Improved Prescribing after Transfer (IPT)). We will evaluate the quantitative effectiveness of the tool in reducing transition drug risk and ADEs. We additionally will conduct focus group discussions and cognitive task analysis among end-users to better understand how providers make drug-prescribing decisions at the time of transfer and to assess factors influencing effective use of the tool.

This is a 2-phase study in which we will employ mixed quantitative and qualitative methods to conduct an evaluation of the IPT tool while improving our understanding of provider prescribing decisions at the time of patient transfer. In Phase 1 we will conduct a 5-month controlled trial among all admissions to 2 units at J.J. Peters (Bronx) VA Medical Center. We will compare IPT with usual care, and compare physician and pharmacist forms of IPT implementation with regard to, as primary outcome, transition drug risk, and, as secondary outcomes, ADEs, provider prescribing-decisions, and hospital utilization. In Phase 2, which will run concurrently with Phase 1, we will perform cognitive task analysis to examine providers' decision-making and to map IPT tool functions while providers interface with the tool, and perform focus group interviews with representative IPT users to identify factors that facilitate or hinder adoption. Results of cognitive analysis and focus groups will be used to identify tool deficiencies to consider for redesign.

Eligibility Criteria:
Inclusion Criteria:

All patients who were admitted to the JJ Peters (Bronx) VA Hospital general medical wards (units 7A and 7B) between 10/05-2/06 and stayed least 24 hours

Exclusion Criteria:

Patients who were transferred to one of the study units wards (units 7A and 7B) from another JJ Peters (Bronx) VA Hospital acute care unit (e.g., an intensive care unit), or who stayed in the hospital less than 24 hours
A Novel Approach for Transjugular Intrahepatic Portocaval Shunt Creation Using Real-time Three Dimensional Roadmap

TIPS creation has been widely used to treat the complications associated with portal hypertension. In association with increased operator experience and the ongoing development of imaging modalities, the rate of major complications associated with TIPS has decreased significantly in the past decades. However, the passage of a curved needle from the hepatic vein into the portal vein still remains a challenging and time-consuming part of the procedure and is associated with puncture-related complications that are potentially fatal.Three-dimensional roadmap guidance has been widely applied in various interventions. The aim of the present study is to prospectively assess the feasibility and efficacy of real-time 3D roadmap guidance during TIPS creation.


Eligibility Criteria:
Inclusion Criteria:

cirrhosis complications of portal hypertension requiring TIPS

Exclusion Criteria:

non-cirrhotic portal hypertension complete occlusion of intrahepatic portal vein gastro-renal shunt presence of liver tumor pregnancy other contradictions of TIPS
Plantar Forces Mid-term After Hemiarthroplasty With HemiCap for Hallux Rigidus

The purpose of this study is to examine variabel pressure gradients of the 1st toe, 2-5th toes and the metatarsal distal caput in patients who have had surgery with a partial proximal hemiarthroplasty in the 1st metatarsalphalangeal joint (MTP) between 2006-2014.

Also, to examine these variables and compare them to the totalt range of motion and pain, to find out if the measured pedobar pressure can be used identify the well treated patient and the poorly treated patient.

The pedobar pressure gradients will be compared with a control group with healthy feet.


Eligibility Criteria:
Inclusion Criteria:

* patients who has hemicap 1. MTP joint.

Exclusion Criteria:

* patients who haad revision surgery, for example removal of hemicap and desis og 1. MTP joint.
Efficacy and Safety of Rabbit Antithymocyte Globulin 3mg/kg in Kidney Transplant Patients Under Steroid-free and CNI Minimization Maintenance Immunosuppressive Regimen

Single-center, prospective, randomized, open-label clinical trial to evaluate the 1-year efficacy and safety of rATG 3mg/kg compared to 6mg/kg in low to moderate immunological risk patients receiving low exposure tacrolimus plus everolimus (EVL) in a steroid-free protocol.


Eligibility Criteria:
Inclusion Criteria:

* Primary kidney transplant recipients, adults

Exclusion Criteria:

* PRA \> 50%
* DSA \> 1500 MFI
* Retransplantation
* Patients who are planning to receive mycophenolate instead of everolimus
* Patients who have planning for follow-up in another center
ASP1517 Pharmacokinetics Study in Anemia Patients on Hemodialysis

To assess the Pharmacokinetics and pharmacodynamics of single doses of ASP1517 in renal anemia patients on hemodialysis. Safety and tolerability will be also evaluated in these patients.


Eligibility Criteria:
Inclusion Criteria:

* Chronic renal failure patients receiving hemodialysis thrice weekly
* Body weight: \>=40.0 and \<80.0 kg
* Mean hemoglobin level \>=10.0 and =\<12.0 g/dL

Exclusion Criteria:

* Patients with severe inflammation or infection
* Patients who have a medical history of gastrointestinal surgery or enterectomy
* Patients who have uncontrolled hypertension
* Patients whose AST, ALT, total bilirubin, GGT exceed the ULN or those who have a medical history of serious liver diseases
* Patients who have a medical history of severe cardiac or cerebrovascular diseases
* Patients who have received blood transfusion or who have had a surgery (except surgery for a shunt) within 4 weeks
* Patients with a medical history of serious drug allergies
* Patients who may be pregnant or lactating, or who refuse to use required birth control during the study period
The FLUYDO NC Post Market Clinical Follow-up Study

The aim of the present observational study is to collect clinical data on the medical device non-implantable medical device Fluydo NC: coronary angioplasty non-compliant balloon dilatation catheter in the daily use in a not selected population.


Eligibility Criteria:
Inclusion Criteria:

* Turkish citizen,
* ≥18 years of age,
* Has indication for percutaneous transluminal coronary angioplasty (PTCA),
* Has indication to treat obstructive lesions of a native coronary artery or aortocoronary bypass or needs post dilatation of coronary stent
* Fluydo NC using in the primary lesion treated during the procedure by the decision physician,
* Has signed and dated the informed consent.

Exclusion Criteria:

* Has a previous diagnosis of coronary artery spasm in the absence of a significant stenosis.
* Needs the device use in an unprotected left main coronary artery
* Device use has not consistent with Instructions for Use.
* Participating in another medical device or pharmaceutical clinical trial.
Parameters of Lung Maturity During Late Pregnancy

- Lung maturity is one of the most important factors in perinatal medicine

* Fetal development passes in many stages till fetal maturation occurs
* We are trying to line out fetal maturation

Eligibility Criteria:
Inclusion Criteria:

* pregnant ladies from 28 weeks till term

Exclusion Criteria:

* pregnant ladies before 28 weeks
Safety and Effectiveness of the QuickFix Small Staple

The prospective, post-market, single-center clinical study will include 45 subjects who are candidates for surgery using the Arthrex QuickFix Small Staple for Akin osteotomy to correct hallux valgus interphalangeus. The purpose of the study is to evaluate the continued safety and effectiveness of the device. Device-related adverse events as well as patient reported outcomes (VAS, FFI, FAAM, VR-12) will be collected up to 1 year postoperative.


Eligibility Criteria:
Inclusion Criteria:

1. Subject requires surgery using the Arthrex QuickFix Small Staple for Akin osteotomy.
2. Subject is 18 years of age or older.
3. Subject is not considered a vulnerable subject (i.e. child, pregnant, nursing, prisoner, or ward of the state).
4. Subject signed informed consent and is willing and able to comply with all study requirements.

Exclusion Criteria:

1. Insufficient quantity or quality of bone.
2. Blood supply limitations and previous infections which may retard healing.
3. Foreign-body sensitivity.
4. Any active infection or blood supply limitations.
5. Conditions that tend to limit the patient's ability or willingness to restrict activities or follow directions during the healing period.
6. Subjects that are skeletally immature.
Caffeine, CYPA12 and Resistance Training

Introduction: Several studies have evaluated and confirmed the ergogenic effect of acute caffeine intake on sports performance, specifically on strength and power performance. However, it remains to be elucidated how CYP1A2 polymorphism influences the prolonged effects of caffeine on this type of exercise.

Objectives: The present study aims to analyze the prolonged effects of caffeine intake on neuromuscular adaptations to resistance training according to CYP1A2 polymorphism in men and women.


Eligibility Criteria:
Inclusion Criteria:

* Age between ≥ 18 and ≤ 35 years.
* Body mass index (BMI) lowe than 25 kg/m².
* Physically active subjects (≥ 150 min/week of moderate exercise).
* Healthy men and women without neurological, cardiometabolic, immunological, or physical conditions that prevent them from performing physical exercise.
* Participants capable of performing the tests.

Exclusion Criteria:

* History of neuromuscular, cardiac, or diseases that could affect liver or muscle metabolism.
* Use of drugs or other stimulants that interfere with caffeine intake and intestinal absorption during the tests and study.
* Body mass index (BMI) ≥ 25 kg/m².
* Having undergone prolonged periods of forced physical inactivity during the 6 months prior to the study.
* Performing strenuous exercise within 48 hours prior to the tests.
* Failing to replicate the same food intake on the two experimental days.
* Consuming caffeine after 6 PM on the day prior to training or testing.
The Effect of Hormonal Contraceptives on Androgens and Glucose Metabolism

The impact of different administration routes of hormonal contraceptives on androgen secretion, glucose metabolism and inflammation. A prospective randomized trial.

The investigators assume, that transdermal or transvaginal hormonal contraception would have less effects on androgen levels, glucose metabolism and inflammatory markers than oral contraceptives.

45 patients are recruited in the study. Each study group will consist of 15 women (aged 20-35 years) receiving oral, transdermal or transvaginal hormonal contraception continuously for 9 weeks. The subjects should have at least 2 months wash out period from all hormonal medication prior to the study.

The measurements for serum sampling and OGTT will be performed before and after 9 weeks of medication.

Eligibility Criteria:
Inclusion Criteria:

* healthy women aged from 20 to 35 years
* regular menstruation
* no use of hormonal contraception or two months wash-out period
* no contraindications for using hormonal contraception

Exclusion Criteria:

* irregular menstruation
* smoking
* alcohol addiction
* pregnancy or nursing
* hypersensitivity to any components of the products
* headaches with focal neurological symptoms
* serious or multiple risk factors for artery disease
* undiagnosed abnormal genital bleeding
* impaired glucose tolerance or DM-T2
Safety and Efficacy of TareSphere Injection and cTACE in Patients With Unresectable HCC

The goal of this clinical trial is to evaluate the efficacy and safety of NRT6003 Injection compared to cTACE in patients with unresectable HCC.

The main questions it aims to answer are:

1. Does NRT6003 Injection improve tumor response rates compared to cTACE in patients with unresectable HCC?
2. What adverse events do participants experience when receiving NRT6003 Injection compared to cTACE?

Investigators will compare NRT6003 Injection to cTACE to determine:

1. Whether NRT6003 Injection demonstrates superior efficacy in tumor control and long-term survival (e.g., objective response rate, time to progression, etc.).
2. Whether NRT6003 Injection has a comparable or improved safety profile vs. cTACE (e.g., incidence of adverse events, etc.).

Participants will:

1. Receive either NRT6003 Injection or cTACE as per randomized assignment.
2. Undergo scheduled follow-up visits for imaging assessments (e.g., MRI or CT scans, etc.) and safety evaluations.
3. Provide blood samples for biomarker analysis.
4. Report any symptoms or medical events through a patient diary and during clinic visits.

Eligibility Criteria:
Key Inclusion Criteria:

1. Diagnosed as hepatocellular carcinoma (CNLC Ⅰa-Ⅲa) clinically, by imaging and/or pathology based on the guideline of the National Health Commission of the People's Republic of China (2024).
2. Evaluated by the investigator as not suitable for surgical resection/ablation/liver transplantation, or there is high risk for surgical resection, or the participant refuses surgical resection/ablation/liver transplantation.
3. Child-Pugh score ≤ 7.
4. Eastern Cooperative Oncology Group performance status ≤ 1.
5. Adequate organ function.

Key Exclusion Criteria:

1. Imaging evidence or suspicion of extrahepatic metastases (including regional lymph node metastases).
2. Prior antitumor treatment for primary hepatocellular carcinoma.
3. Prior external radiation therapy or intra-arterial brachytherapy.
4. Liver vascular evaluation results that do not meet all the requirements of the study.
Safety and Tolerance Study of Grass Pollen-derived Peptides to Treat Allergic Rhinitis

The purpose of this study is to determine whether the oral administration of grass pollen peptides to treat allergic rhinitis is safe and well tolerated.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 50 years
* The subjects are in good physical and mental health according to his/her medical history, vital signs, and clinical status
* Male or non-pregnant, non-lactating females
* A history of seasonal allergic rhinoconjunctivitis (SAR) during the grass pollen season during at least the last two years
* A positive skin prick test to grass-pollen mixture
* Specific IgE against grass pollen (RAST class 2 or IgE \> 0.7 kU/l)
* Asymptomatic to perennial inhalant allergens

Exclusion Criteria:

* Subjects with current or past immunotherapy for SAR
* Subjects requiring controller medication against asthma (bronchodilator nebulised drugs or local or systemic corticosteroids)
* Documented evidence of acute or significant chronic sinusitis (as determined by individual investigator)
* Subjects with a history of food allergy and consecutive anaphylaxis
* Subjects with a history of hepatic or renal disease
* Subject with malignant disease, autoimmune disease
* Female subjects who are pregnant, lactating, or of child-bearing potential and not protected from pregnancy by a sufficiently reliable method (OCs, IUD).
* Females unable to bear children must have documentation of such (i.e. tubal ligation, hysterectomy, or post menopausal \[defined as a minimum of one year since the last menstrual period\])
* Any chronic disease, which may impair the subject's ability to participate in the trial (i.e. severe congestive heart failure, active gastric or duodenal ulcer, uncontrolled diabetes mellitus, etc...)
* Subjects with clinically relevant abnormal QTc intervals of the ECG : QTc \> 450 ms for man and \> 470 ms for women
* Subjects requiring beta-blockers medication
* Chronic use of concomitant medications that would affect assessment of the effectiveness of the study medication (e.g. tricyclic antidepressants)
* Subject with febrile illness (\> 37.5°C, oral)
* A known positive serology for HIV-1/2, HBs antigen or anti-HCV antibodies
* The subject is immunocompromised by medication or illness, has received a vaccine, corticoids or immunosuppressive medications within 1 month before study entry
* Receipt of blood or a blood derivative in the past 6 months preceding study entry
* Regular consumption of corticoids (oral, topic or nasal) or of anti-histaminic drugs within 4 weeks preceding the study, any consumption of corticoids (oral, topic or nasal) or of anti-histaminic drugs within 1 week preceding the study
* Use of long-acting antihistamines
* Any condition which could be incompatible with protocol understanding and compliance
* Subjects who have forfeited their freedom by administrative or legal award or who are under guardianship,
* Participation in another clinical trial and/or treatment with an experimental drug within 1 month of study start
* A history of hypersensitivity to the excipients