cyrilzakka/clinical-trials huggingface dataset:
Varian ProBeam Proton Therapy System Clinical Trial (Shandong)

This study is prospective, single-center, single-arm objective performance criteria.

This trial will be conducted with a total of 47 subjects enrolled. All of subjects will be treated with radiation therapy using the medical device Varian ProBeam Proton Therapy System (ProBeam), aim to compare the data with objective performance criteria (OPC) to evaluate the effectiveness and safety of ProBeam radiotherapy system for oncology patients, providing a clinical basis for the medical device registration.

Oncology patients, including tumors of head and neck, chest, abdomen, spine, pelvic cavity, extremities and other tumors. The screening period from informed consent to enrollment is expected to be 2 weeks, while the treatment period depends on patient medical situation and treatment plan. The period after the last treatment is divided into short-term follow-up which is 90 days after treatment completion and long-term follow-up which is 5 years after treatment completion. The clinical trial with short-term follow-up fulfills the requirements for National Medical Products Administration (NMPA) regulatory registration. All the end points claimed will be achieved in the short-term follow-up stage. The trial is defined as completion once short-term follow-up is finished.

And long-term follow-up report will be submitted for future post market evaluation when requested by NMPA.

Eligibility Criteria:
Inclusion Criteria (Major Criteria):

1. Patients diagnosed with histological/pathological diagnosis and/or with imaging, laboratory examination and other evidence, clinically diagnosed as benign and malignant intracranial tumors, and malignant solid tumors of the head and neck, chest, abdomen, spine, pelvis, and extremities;
2. Eastern Cooperative Oncology Group (ECOG) physical condition grade ≤ 2;
3. Women of childbearing had negative results in the blood pregnancy test (Human Chorionic Gonadotropin, HCG) 7 days prior to the first treatment;
4. The subject or subject's guardian is able to understand the purpose of the study, demonstrate sufficient compliance with the protocol and sign informed consent form.

Exclusion Criteria (Major Criteria):

1. There are contraindications to radiation therapy, including congenital susceptibility to ionizing radiation hypersensitivity; or the presence of comorbidity that may lead to ionizing radiation hypersensitivity, which will increase the sensitivity of normal tissues to radiation therapy;
2. The tumor recurring at the same site has received two or more radiotherapy treatments;
3. Active implants such as cardiac pacemakers, defibrillators, cochlear implants, drug infusion pumps, other nerve stimulators, etc. (whether they are turned on or not) within the scope of radiotherapy ; or passive implants that affect radiotherapy thing;
4. Other situations that investigator determines not suitable for enrollment.
A Clinical Study on Ozone Autohemotherapy for the Treatment of Acute Ischemic Stroke

Clinical studies applying ozonated autohemotherapy to treat acute cerebrovascular diseases have validated the safety and efficacy of this treatment, as well as explored its mechanism of action.


Eligibility Criteria:
Inclusion Criteria:

1. Confirmed by cranial CT or MRI examination, first-ever stroke, hospital admission within \<24 hours of symptom onset,
2. age \>18 years,
3. NIHSS score between 4 and 15,
4. TOAST classification as large artery atherosclerosis,
5. complete clinical records, minimum follow-up period of ≥3 months post-discharge,
6. willingness to undergo brachial blood puncture treatment, and provision of informed consent

Exclusion Criteria:

1. other neurological disorders, cerebral infarction caused by vertebral-basilar artery disease, cardioembolic stroke, or large-vessel vasculitis, acute or chronic infectious diseases, autoimmune or hematologic disorders, malignant tumors, mental abnormalities, severe heart, liver, or kidney dysfunction, intracerebral hemorrhage, and craniocerebral surgery history.
2. Contraindications for ozone therapy included hyperthyroidism, favism, severe coagulation disorders, and abnormal puncture site barriers
A Prospective Trial of Ayurveda for Coronary Artery Disease

Can Ayurvedic therapy improve markers of cardiovascular health and cardiovascular risk factors in patients with coronary artery disease.

Patients with established coronary artery disease will be treated with 90 days of Ayurvedic therapy to include yoga, meditation, breathing exercises,and herbs. Arterial stiffness, weight, BMI, BP, medications, cholesterol, LDL, HDL, triglyceride, HS-CRP will be measured at baseline and after 90 days of therapy.

Eligibility Criteria:
Inclusion Criteria:

* stable coronary artery disease (prior mi, coronary angioplasty or stent, coronary bypass surgery)

Exclusion Criteria:

* age \< 18 years
* life expectancy \< 6 months
* pregnancy or breast feeding
* unwilling or unable to complete 90 days of therapy
* already receiving/taking Ayurvedic therapy
* unable to converse in or understand English language
Study Evaluating ReFacto AF in Severe Hemophilia A

To characterize the safety and efficacy of ReFacto AF in treating acute bleeding episodes during prophylaxis treatment, including neoantigenicity.


Eligibility Criteria:
Inclusion Criteria:

* Severe hemophilia A (FVIII:C less than or equal to 2% at local laboratory)
* Previously treated patients with greater than or equal to 250 exposure days to any Factor VIII product
* Age greater than or equal to 12 years
* History of prophylaxis dosing at least twice per week on any Factor VIII product for at least 3 consecutive months within the 2 years prior to study enrollment unless the patient completed the previous pharmacokinetic study
* Adequate laboratory results

Exclusion Criteria:

* Presence of any bleeding disorder in addition to hemophilia A
* Concomitant therapy with immunosuppressive drugs
* Current or historical Factor VIII inhibitor
* Treatment with any investigational drug or device within the past 30 days
A Phase 2 Study Comparing TAS-102 Versus Topotecan or Amrubicin to Treat Small Cell Lung Cancer Following Platinum-Based Chemotherapy

The purpose of this trial is to compare the effects of TAS-102 with either amrubicin or topotecan (drugs used in Small Cell Lung Cancer) on lung cancer to find out the effects on survival, how much time may pass without disease progression, and the safety of TAS-102.

This is a multicenter, open-label, two-arm, randomized Phase 2 study of TAS-102 versus Investigator's choice of therapy in patients requiring second-line chemotherapy for SCLC refractory or sensitive to first-line platinum-based chemotherapy. Investigator's choice of therapy is defined as second-line chemotherapy with IV topotecan (Europe/Japan) or IV amrubicin (Japan). Patients will be stratified by response to first-line platinum-based chemotherapy (sensitive vs refractory). Sensitive patients are defined as patients who did not progress within 90 days after the last dose, and refractory patients are defined as patients who never responded or who responded but had radiologic progression \< 90 days after the last dose.

Eligibility Criteria:
Inclusion Criteria:

1. Has provided written informed consent
2. Is ≥18 years of age for patients enrolled in Europe; or ≥20 years of age for patients enrolled in Japan
3. Has definitive histologically or cytologically confirmed SCLC (limited or extensive disease)
4. Has progressed or had recurrence within 30 days prior to randomization
5. Has at least one measurable lesion, as defined by RECIST criteria version 1.1
6. ECOG performance status of 0, 1, or 2
7. Is able to take medications orally
8. Has adequate organ function (bone marrow, kidney and liver)
9. Women of childbearing potential must have a negative pregnancy test and must agree to adequate birth control if conception is possible. Males must agree to adequate birth control.

Exclusion Criteria:

1. Has cerebral metastases (unless metastases have been treated and controlled, metastases have been stable for at least 2-months post-intervention, and patient is not receiving corticosteroid treatment)
2. Certain serious illnesses or medical condition(s)
3. Has had certain other recent treatment e.g. major surgery, anticancer therapy, extended field radiation, received investigational agent, within the specified time frames prior to study drug administration
4. Has received TAS-102
5. Has unresolved toxicity of greater than or equal to CTCAE Grade 2 attributed to any prior therapies
6. Is a pregnant or lactating female
A Study to Describe Pediatric Influenza Vaccine Coverage

The purpose of this study is to describe flu vaccine coverage in children under 18 years of age and to examine correlations between in-office flu vaccine coverage and the use of various tactics to increase vaccine coverage.

To describe influenza vaccine coverage in children less than 18 years of age in practicing pediatricians' offices and family medicine physicians' offices and to examine correlations between in-office influenza vaccine coverage and the use of various tactics to increase vaccine coverage.

Eligibility Criteria:
Sites selected to participate were required to be able to accurately identify the number of patients under their care by age group and provide influenza vaccine at their location.
Comparison of Insulin Glargine Against Insulin Aspart Infused Under the Skin in Patients With Type 2 Diabetes

This trial is conducted in Europe. The objective of the study is to investigate the effect and safety of continously basal delivered insulin aspart given by a pump versus once daily injection of insulin glargine.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with type 2 diabetes for more than 2 years
* Subjects currently treated with unchanged insulin glargine dose (10 -100 units) for 2 weeks
* Subjects currently treated with unchanged dose(s) for at least 1 month on one or two Oral Anti-diabetic drugs
* BMI 25 - 40 kg/m2
* HbA1c \< 9.5 %

Exclusion Criteria:

* Known or suspected allergy to trial product(s) or related products
* Previous randomisation in this trial
* Pregnancy, breast-feeding, intention of becoming pregnant or pre-menopausal women judged not to be using adequate contraceptive measures (Only sterilisation, intra uterine devices and contraceptive pills are considered adequate contraceptive methods)
* Mental incapacity, unwillingness or language barriers precluding adequate understanding and co-operation.
* Any other significant illness such as endocrine, cardiac, neurological, malignant or other pancreatic illness judged by Investigator
* Participation in other studies within the last three months
Vaccine Therapy in Treating Patients With Myelodysplastic Syndrome

RATIONALE: A vaccine made from a person's myelodysplasia cells may make the body build an immune response to kill cancer cells. Combining vaccine therapy with sargramostim may kill more cancer cells.

PURPOSE: Phase I trial to study the effectiveness of vaccine therapy plus sargramostim in treating patients who have myelodysplastic syndrome.

OBJECTIVES: I. Determine whether a specific T-cell response can be induced in patients with myelodysplastic syndrome treated with mutant N-, K-, or H-ras peptide vaccine (limited to the specific N-, K-, or H-ras peptide mutation in their bone marrow) and intradermal sargramostim (GM-CSF). II. Determine whether HLA type or the ability to respond immunologically to common recall antigens correlates with the induction of anti-ras immune responses in these patients treated with this regimen. III. Assess toxicity of mutant N-, K-, or H-ras peptide vaccine in these patients.

OUTLINE: Patients receive sargramostim (GM-CSF) intradermally on days 1-10. Patients receive mutant N-, K-, or H-ras peptide vaccine (limited to the specific N-, K-, or H-ras mutation in their bone marrow) intradermally on day 7. Treatment repeats every 4 weeks for up to 5 courses in the absence of disease progression or unacceptable toxicity. Patients are followed at 2 and 6 weeks after the last vaccination.

PROJECTED ACCRUAL: A total of 25-70 patients will be accrued for this study over 12-15 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically proven myelodysplastic syndrome (MDS) with 1 of the following classifications: Refractory anemia Refractory anemia with ringed sideroblasts Refractory anemia with excess blasts Chronic myelomonocytic leukemia History of MDS, received chemotherapy for acute leukemia within past 12 months, and now in remission Myelodysplastic disease must be stable (not anticipated to require chemotherapy for at least 4 months) Must have 1 of the following N-, K-, or H-ras peptide mutations: Progenitor cells contain aspartic acid, valine, or serine substitution at codon 12, OR Aspartic acid or arginine substitution at codon 13

PATIENT CHARACTERISTICS: Age: Over 17 Performance status: ECOG 0 or 1 Life expectancy: Greater than 5 months Hematopoietic: WBC at least 1,500/mm3 Platelet count at least 50,000/mm3 Hepatic: Not specified Renal: Not specified Cardiovascular: No New York Heart Association class III or IV heart disease Other: Not pregnant or nursing Fertile patients must use effective contraception No other medical condition that might prevent completion of study or prevent immunological response to study regimen No other concurrent serious medical illness No active bleeding

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Endocrine therapy: No concurrent immunosuppressive drugs including systemic steroids or antiinflammatory drugs Radiotherapy: No prior irradiation of spleen Surgery: No prior splenectomy
Carbetocin vs. Oxytocin for Prevention of Postpartum Bleeding in Patients With Severe Preeclampsia

Postpartum hemorrhage is an important cause of maternal morbidity and mortality. In patients with severe preeclampsia there is an increased risk of postpartum hemorrhage but the hemodynamic changes associated with this pathology make the management of any kind of bleeding particularly troublesome. There are many pharmacological options, being oxytocin the first line of treatment. However there is no evidence about the safety and efficacy of carbetocin, an oxytocin agonist. The investigators aimed to compare oxytocin with carbetocin for the routine prevention of postpartum hemorrhage in patients with severe preeclampsia.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women between 28 weeks and term
* Severe pre-eclampsia

Exclusion Criteria:

* Twin pregnancy
* Coagulation disorders
* HELLP Syndrome
* Eclampsia
Prophylactic Cervical Cerclage in Twin Pregnancies With Non-shortened Cervix

This randomized controlled trial is aimed to assess the protective value of prophylactic cervical cerclage against preterm birth in twin pregnancies with history of one or more preterm births without having cervical shortening in the current pregnancy.

Multiple pregnancies are high-risk pregnancies and usually associated with an increased risk of neonatal morbidity and mortality, mainly due to preterm births. Preterm births occur in 50% of twin pregnancies and the mean gestational age for delivery is 35.3 weeks. Ten percent of all twin births take place before 32 weeks of gestation.1 Preterm births are responsible for more than 70% of all neonatal and infant deaths.2 Prematurity can have serious consequences for the child, such as hearing difficulties, vision impairment, learning disabilities, reduced IQ, and cerebral palsy. A cervical length of ≤25 mm in twin pregnancies is a good predictor of a spontaneous preterm birth when measured around 24 weeks of gestation.3,4 Numerous interventions have been attempted in order to prevent preterm births in twin gestations, but until now, no intervention has been effective. Use of cerclage in twin pregnancies is controversial. Some experts claim that placing a cervical cerclage could increase the risk of preterm births5, Fuchs and Senat6 concluded that cervical cerclage in asymptomatic twins did not reduce the risk of PTB. This conclusion came depending on small sample sized randomized trail done on less than 50 patients.7 Available meta-analytic data remained of limited value in view of the few and small clinical studies that were included.

Although the current meta-analyses indicate the lack of efficacy of cerclage in twin pregnancies, data from the US Standard Certificate of Live Birth indicated that roughly 10% of triplets and 1.3% of twins are still receiving cerclage.8 Some authors compared the efficacy of cerclage in twin pregnancies and singleton pregnancies and showed that women with twin pregnancies who received cerclage might show beneficial obstetric outcomes similar to those of women with singleton gestations.9,10 Such practice is still in need for further validation by well-structured and powered randomized controlled trials.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18-50 years.
* Dichorionic twins.
* History of ≥1 preterm birth.
* Transvaginal sonographic cervical length is ≥25 mm at 14-20 weeks gestational age.
* Asymptomatic.

Exclusion Criteria:

* Triplets and quadruplets.
* Monochorionic twins.
* Threatened/ inevitable miscarriage
* Bulging membranes through the external os.
* Extremes of age.
* Major fetal anomalies.
* Known cases with uterine anomalies e.g. bicornuate uterus, uterus didelphis... etc.
* Fetal demise.
* Fetal reduction in the current pregnancy.
Oral Intradialytic Amino Acid Supplementation to Vitalize End-stage Kidney Disease Patients on Hemodialysis

The study will test and compare the efficacy of a single essential amino acid valine with a combination of essential amino acids (EAA) supplement on fatigue, frailty, and cognitive function in end-stage kidney disease (ESKD) patients undergoing hemodialysis (HD) treatment.

This single center outpatient study will test and compare the efficacy of a single essential amino acid, valine with a combination of essential amino acids (EAA) supplementation on fatigue, fragility and cognitive function in end-stage kidney disease (ESKD) patients aged 18-64 years undergoing hemodialysis (HD) treatment at least three times a week.

Eligibility Criteria:
Inclusion Criteria:

1. Male or Female
2. Age 18-64 years
3. Receiving 3 x weekly in clinic hemodialysis for at least 6 months

Exclusion Criteria:

1. Hypersensitivity to amino acid(s) and/or any excipient
2. Clinical documentation of COVID-19
3. Concomitant intake of amino acids supplements
4. Current use or abuse of alcohol, marijuana, narcotic, or other substances
5. Heart failure receiving active management
6. Malignant cancer receiving anticancer therapy
7. Diagnosis of major depressive disorder receiving antidepressants
8. Diagnosis of chronic liver disease
9. Cerebrovascular disease with sequelae
10. Upper limb amputation, osteoarthritis, or degenerative diseases of fingers, carpel tunnel syndrome in the non-fistula or graft hand preventing completion of hand grip strength test.
Efficacy and Safety Study of Lamotrigine to Treat Trigeminal Neuralgia

The purpose of this study was to determine the efficacy and safety of lamotrigine in patients with trigeminal neuralgia (TGN).

Trigeminal Neuralgia (TGN) is a rare form of chronic facial pain shrouded in mystery, although not life threatening, can be excruciating painful and extraordinarily debilitating. Its uniqueness and peculiarity can be ascertained by the fact that TGN may present to and be managed by dentists, neurologists, neurosurgeons, oral surgeons and ear, nose and throat surgeons.

The management of TGN is initially medical, with the "gold standard" drug of carbamazepine (CBZ). Whilst CBZ continues to be the treatment of choice, a substantial proportion of patients tolerate this drug poorly, predominantly because of side-effects that include drowsiness, accommodation disorders, hepatitis, elevation in liver enzymes, renal dysfunction, congestive heart failure, delayed multi-organ failure, leucopenia, thrombocytopenia etc. etc. If pain-relief is incomplete with CBZ or it produces adverse side-effects, options include using an alternative second-line medical agent. The drugs suggested to be considered as second-line agents for the treatment of TGN, include: lamotrigine, baclofen, phenytoin, oxcarbazepine, gabapentin, clonazepam, valproate, mexiletine, and topiramate.

Lamotrigine (LTG), a novel anticonvulsant, which has not been adequately assessed for its antineuralgic properties. It has a bimodal mechanism of action:

* inhibits the release of glutamate and aspartate by blocking voltage-sensitive sodium channels
* antagonistic at neuroexcitatory N-methyl-d-aspartate receptors.

It can also acts at and inhibits calcium channels to enhance the gamma- Aminobutyric acid (GABA) synthesis. GABA is an inhibitory amino acid neurotransmitter that decreases neural membrane action potentials and therefore decreases nerve excitability. Glutamate has been implicated in the mechanisms contributing towards phenomenon of chronic pain, such as sensitisation and wind up. LTG through its inhibition of pathological release of glutamate, has the potential towards management of chronic pain, particularly of neuropathic origin.

Lamotrigine, therefore has the potential to be a promising new treatment for TGN.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Trigeminal Neuralgia
* Male; or non-pregnant/non-lactating female
* Must be willing to cooperate with and understands study instructions
* Signed informed consent prior to entering study

Exclusion Criteria:

* psychiatric illness
* severe liver or cardiovascular disease
* renal impairment, low white cell count
* malignancy
* pregnancy or lactation
* alcohol or recreational drug abuse
* and positive tests for human immunodeficiency virus or hepatitis B or C.
Evaluation of Post-Induction Hypotension Treatment with PRAM Method

The goal of this observational study is to compare post-induction hypotension treatments with PRAM method in Gynecologic Oncological Cases. The goal of this observational study is to compare post-induction hypotension treatments with PRAM method in Gynecologic Oncological Cases.

Post-induction hypotension is defined as hypotension that occurs within the first 20-30 minutes after general anesthesia induction or during the period between anesthesia induction and surgical incision. The global incidence rates are reported to be approximately 10.3%, with some studies indicating rates as high as 66.96%. Post-induction hypotension is associated with increased postoperative morbidity risks, such as acute kidney injury, transient tubular dysfunction, myocardial injury, and the need for postoperative intensive care. However, hypotension is a modifiable and preventable risk factor; its early detection and appropriate treatment can improve patient outcomes.

For this reason, investigators aimed to investigate the repeated dose requirements of alpha-adrenergic drugs, the recurrence of hypotension, and their effects on parameters observed via the MostCare monitor in patients undergoing major gynecologic oncologic surgeries during standard anesthesia induction and maintenance. This investigation focuses on patients experiencing a mean arterial pressure \<65 mmHg or a \>30% reduction in baseline systolic blood pressure within the first 30 minutes after induction or until surgical incision. Additionally, our secondary aim is to examine other parameters that may be associated with post-induction hypotension.

Eligibility Criteria:
Inclusion Criteria:

* Above 18 years old
* Operated for Gynecologic Oncological reasons
* BMI\<35

Exclusion Criteria:

* Refusal to participate in the study
* Additional spinal or epidural anesthesia
* Dementia patients from whom consent could not be obtained
* Atrial fibrillation with a rapid ventricular response
* Patients with difficult ventilation and/or difficult intubation
* Left ventricular ejection fraction (EF) below 30%
* Severe aortic valve stenosis
* Obesity (BMI \>35)
* Chronic beta-blocker use