cyrilzakka/clinical-trials huggingface dataset:
Vaccine Therapy Following Chemotherapy & Peripheral Stem Cell Transplantation in Treating Non-Hodgkin's Lymphoma

RATIONALE: Vaccines made from a person's cancer cells may make the body build an immune response to kill cancer cells. Vaccine therapy may be an effective treatment for non-Hodgkin's lymphoma.

PURPOSE: Phase II trial to study the effectiveness of vaccine therapy following chemotherapy and peripheral stem cell transplantation in treating patients who have non-Hodgkin's lymphoma.

OBJECTIVES:

* Determine the humoral and cellular immune responses in patients with follicular non-Hodgkin's lymphoma treated with autologous lymphoma-derived idiotype vaccine with keyhole limpet hemocyanin plus sargramostim (GM-CSF).
* Determine the safety and toxicity of this regimen in these patients in the post-transplant setting.
* Determine the changes in quantitative bcl-2 in the blood and bone marrow of these patients before and at various times after the series of idiotype vaccines.

OUTLINE: Vaccinations begin at day 100 or up to 6 months after hematopoietic stem cell transplantation. Patients receive autologous lymphoma-derived idiotype vaccine plus keyhole limpet hemocyanin subcutaneously (SC) on day 1. Sargramostim (GM-CSF) SC is administered on days 1-4. Treatment repeats every 4 weeks for 4 doses, followed 12 weeks later by the fifth and final dose.

Patients are followed every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

Eligibility Criteria:
Inclusion Criteria:

* Over 19 years of age
* Histologically proven grade I, II, or III follicular non-Hodgkin's lymphoma that failed induction therapy
* Minimal disease state at day 100 to 6 months post-transplantatio

  * Lymph nodes smaller than 2 centimeters (cm)
  * Less than 20% bone marrow involvement with lymphoma
  * Uncertain complete remission, defined by greater than 75% reduction in the size of the pre-transplantation mass not representing active disease
* Tissue sample safely accessible by biopsy, needle aspiration, or phlebotomy

  o Must have adequate circulating lymphoma cells
* Karnofsky greater than 70%
* Absolute neutrophil count greater than 1,000/mm\^3 (No restrictions if study vaccine administered at 6 months after transplantation)
* CD4+ count greater than 200/microliter (No restrictions if study vaccine administered at 6 months after transplantation)
* Bilirubin less than 2.0 mg/dL (unless due to lymphomatous involvement)
* Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamic pyruvic transaminase (SGPT) less than 2 times normal (unless due to lymphomatous involvement)
* Creatinine no greater than 2.0 mg/dL
* Fertile patients must use effective contraception during and for 6 months after study participation

Exclusion Criteria:

* Previously received no more than 2 high-dose chemotherapies before hematopoietic stem cell transplantation
* Not pregnant or nursing/negative pregnancy test
Self-Esteem Status Among Medical Students: A Descriptive Study

The goal of this observational study is to assess the status of self-esteem in medical students of a medical college, focusing on different academic years, and various sociodemographic factors. The main questions it aims to answer are:

What is the prevalence of low, normal, and high self-esteem among medical students?

How do sociodemographic factors (age, gender, nationality, scholarship status, religion, academic year, education level of parents, occupation of parents, motivation behind choosing medicine as a career) influence self-esteem in medical students?

Since this is an observational study, there is no formal comparison group. Researchers will explore the variations in self-esteem levels based on sociodemographic characteristics.

Participants will complete a semi-structured questionnaire providing demographic details, such as age, gender, academic year, and parental education/occupation, and answering the Rosenberg Self-Esteem Scale.

Self-esteem is the assessment and experience related to self-value, the insight of self-ability as well as the reception of the whole self. Abraham Maslow involved self-esteem in his "hierarchy of human needs" which he depicted it in two forms - the need for respect from others (in the form of recognition, success, and admiration), and the need for self-respect (in the form of self-love, self-confidence, skill, or aptitude).

Despite being a predictor of high academic achievement and overall happiness, very few studies are done in medical students of Nepal. This study aims to assess the status of self-esteem in medical students and compare the prevalence of low, normal and high self-esteem among medical students of different academic years. For this study, Rosenberg Self-Esteem Scale tool is being used. To obtain the data for the study, convenience sampling technique will be used. Research is conducted among medical students of Kathmandu Medical College and Teaching Hospital, from 20th August to 10th September. The sample size is calculated as 227. The data will be collected via a semi-structured questionnaire in the English language via Google Forms. SPSS version 26.0 will be used to analyse the data.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or older
* Medical students from first year to final year studying Bachelor in Medicine and Bachelor in surgery at Kathmandu Medical College and Teaching Hospital
* Willing to participate in the study and provide informed consent.

Exclusion Criteria:

* Student studying Bachelor of Dental Surgery and Paramedical Studies
* Those who do not fill up the form completely
* Those who are interns and already graduated from medical college
* Those who do not give consent
Effects of US-guided SAPB During Breast Surgery

The serratus anterior plan (SAP) block is a technique that has recently gained popularity in the context of breast surgery. SAP block resulted in better hemodynamic stability, early ambulation and shorter hospital stay, as well as hospital costs for postoperative breast patients.

We aimed to investigate the effects of the serratus anterior plane block in women undergoing breast surgery, in the intraoperative period.


Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 18-75,
* ASA I-II-III risk group
* Patients who underwent breast surgery under general anesthesia, who underwent serratus anterior plan block for analgesia, or who were provided analgesia with conventional methods
* Patients whose informed consent was read and whose consent was obtained

Exclusion Criteria:

* who do not want to participate in the study,
* ASA IV-V patients
Mannitol - Potential Role in Hemodialysis Initiation for Reduction of Intra-dialytic Hypotension

Kidney failure can result from a variety of conditions and can be temporary or permanent. Hemodialysis is available as a replacement treatment to perform the work that the kidneys normally do. However, the dialysis procedure can be associated with rapid changes in the composition of the blood - this may lead to changes in blood pressure and in turn reduced blood supply to important parts of the body. We aim to investigate if giving a medicine (called mannitol) during dialysis may be able to reduce the frequency of these low blood pressure events.


Eligibility Criteria:
Inclusion Criteria:

* Renal failure requiring intermittent hemodialysis initiation; adult patients aged over 18 years; written informed consent

Exclusion Criteria:

* Hyponatremia \<130 mmol/L; acute myocardial infarction or stroke in previous 7 days; cardiac transplant; ventricular arrhythmia; unstable angina; use of pressors/midodrine; enrollment in conflicting research study; institutionalized individuals; pregnancy; prisoners; documented allergy to mannitol
Increased Calorie Intake to Reverse Energy Deficiency in Exercising Women: Impact on Bone and Menstrual Cyclicity

The purpose of this study is to examine the effects of increased food intake on the menstrual cycle and bone health in physically active women who have irregular or absent menstrual cycles. This study will examine whether a 12 month period of increased food intake will cause menstrual cycles to resume and help bones get stronger.

Low levels of estrogen found in physically active, premenopausal women with irregular or absent menstrual periods is likely caused by insufficient energy (calorie) intake compared to energy expenditure. Premenopausal women with menstrual disturbances and amenorrhea suffer from reductions in bone mineral density, particularly in the lumbar spine. Bone loss observed in amenorrheic women may be serious enough to result in osteoporotic fractures, but is also associated with a high prevalence of stress fractures. Increased calorie intake should help improve energy status, menstrual status, and bone health.

Comparison: Premenopausal women with irregular or absent menstrual periods will be assigned to either receive additional calories or serve as controls. A group of premenopausal women with normal menstrual periods will also be used for comparison.

Eligibility Criteria:
Inclusion Criteria for Ovulatory Control Volunteers:

* 18-35 years
* BMI 16-25 kg/m2
* At least 2 hr/wk of aerobic exercise
* Gynecological age \>/= 5 years
* Weight stable (+/- 2 kg) last 6 months
* History of regular menses for 6 months

Inclusion Criteria for Women with Irregular or Absent Menses:

* 18-35 years
* BMI 16-25 kg/m2
* At least 3 hr/wk of aerobic exercise
* Gynecological age \>/= 5 years
* Weight stable (+/- 2 kg) last 6 months
* No menses within past 3 months or 6 or less menses in last 12 months
* Low to normal bone mass (L1-L4 Z score \</=0)

Exclusion Criteria for all participants:

* Hormonal contraceptives in last 6 months
* Smoking currently
* Current clinical diagnosis of an eating disorder
* Use of medications incompatible with measurement of reproductive or metabolic hormones, including thyroid medications that may interfere with any of the study outcomes.
* Dietary habits incompatible with prescribed diet for study
* Any metabolic, reproductive or bone disease
* Sedentary individuals with less than 120 minutes (2 hrs) of activity per week
Dapsone 100 Mg Versus 50 as Primary Prophylaxis for Pneumocystis Carinii Pneumonia (PCP) in Patients With AIDS-Related Complex (ARC)

To determine which of 2 doses of dapsone is effective prophylaxis for Pneumocystis carinii pneumonia (PCP) in patients with oral thrush or hairy leukoplakia and less than 400 CD4 lymphocytes per mm3. To determine whether the long-term toxicities associated with daily dapsone in this population are tolerable.


Eligibility Criteria:
Inclusion Criteria

The patient must have HIV positive antibody test and presence of oral thrush or hairy leukoplakia.

* Patient must be willing and able to sign informed consent.

Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

* Prior Pneumocystis carinii pneumonia (PCP) or AIDS-defining condition.
* Prophylaxis for PCP in preceding 3 months.
* Absence of detectable glucose-6-phosphate dehydrogenase (G6PD) activity.
* Prior type I hypersensitivity (anaphylaxis, urticaria, angioedema) or exfoliative dermatitis during treatment with dapsone.
* History of poor compliance.

Concurrent Medication:

Excluded:

* Zidovudine (AZT).

Patients with the following are excluded:

* Prior Pneumocystis carinii pneumonia (PCP) or AIDS-defining condition.
* Prophylaxis for PCP in preceding 3 months.
* Absence of detectable glucose-6-phosphate dehydrogenase (G6PD) activity.
* Concurrent or prior therapy with zidovudine (AZT).
* Prior type I hypersensitivity (anaphylaxis, urticaria, angioedema) or exfoliative dermatitis during treatment with dapsone.
* History of poor compliance.

Prior Medication:

Excluded:

* Zidovudine (AZT).
Intraocular Pressure and Optic Nerve Sheath Diameter Changes at Different PEEP Levels

Positive end-expiratory pressure (PEEP) is sometimes used during perioperative period, as it has favourable effects on lung mechanics. Unfortunately, it has some negative effects on the patients, like increased intraabdominal, intrathoracic, intracranial and intraocular pressures. In this study the investigators aimed to investigate the effects of different PEEP levels on the patients' intraocular and intracranial pressures. Intraocular pressure will be measured by ocular tonometry, and intracranial pressure will be estimated by optic nerve sheath diameter measurement. The measurements will be performed in the operating room in the patients undergoing laparotomic surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing laparotomy for gastrointestinal surgery
* American Society of Anesthesiologists (ASA) 1 or 2 physical status
* Elective surgery

Exclusion Criteria:

* Patients with glaucoma
* ASA 3 or over physical status
* Emergency surgery
Methylprednisolone in the Treatment of Patients With Signs of Severe Acute Respiratory Syndrome in Covid-19

This is a double-blind, randomized, placebo-controlled, phase IIb clinical trial to assess the efficacy of injectable methylprednisolone sodium succinate (MP) in patients with severe acute respiratory syndrome (SARS) in COVID-19 infection. A total of 416 individuals of both sexes, aged over 18 years old, with symptoms suggestive or confirmed diagnosis of severe acute respiratory syndrome (SARS), hospitalized at the Hospital and Pronto-Socorro Delphina Rinaldi Abdel Aziz (HPSDRAA), with clinical and radiological findings suggestive of SARS-CoV2 infection, will be randomized at a 1:1 ration to receive either MP (0.5mg/kg of weight, twice daily, for 5 days) or placebo (saline solution, twice daily, for 5 days).


Eligibility Criteria:
Inclusion Criteria:

1. Suspected cases of COVID-19, from clinical and radiological data, during the pandemic;
2. Adult aged 18 years or older, at the time of inclusion (children under 18 will not be included due to the recognized lower lethality in previous published studies, and the difficulty of consent in the context of an emergency in public health);
3. SpO2 ≤ 94% in room air OR in use supplementary oxygen OR under invasive mechanical ventilation

Exclusion Criteria:

1. History of hypersensitivity to MPS;
2. People living with HIV and AIDS;
3. Chronic use of corticosteroids or immunosuppressive agents;
4. Pregnancy or breastfeeding;
5. Decompensated cirrhosis;
6. Chronic renal failure.
IUA Committee Research Project on the Management of TASC C and D Aortoiliac Lesions

This study aims to evaluate the clinical, imaging results of endovascular revascularization of the aorto-iliac sector in comparison with aortobifemoral bypass and the hybrid approach, in patients with atherosclerotic disease of the iliac sector classified as type C and D by the TransAtlantic Inter-Society Consensus (TASC II

Open surgery repair with Aortobifemoral Bypass (ABF) remains the gold standard revascularization technique in patients with lifestyle-limiting intermittent claudication (IC) and chronic limb-threatening ischemia due to extensive Aortoiliac Occlusive Disease (AIOD), particularly in Trans-Atlantic Inter-Society Consensus II (TASC-II) type D lesions

The ABF procedure has proven safe, effective, and durable, particularly considering its high long-term patency rates (85%-90% at five years and 75%-80% at ten years) despite its significant peri-operative associated morbidity (1). On the other hand, endovascular treatment (EVT) offers an attractive alternative with durable results (four- or 5-year primary and secondary patency rates ranged from 60% to 86% and 80% to 98%, respectively), especially in less extensive AIOD, while also providing less perioperative morbidity, making it generally preferable for patients with more severe comorbid conditions.

Thus, surgical approaches to extensive AIOD have changed considerably over the last years, primarily due to increased EVT, particularly with the uncovered aortoiliac stenting (AIS). While TASC II provides an anatomical framework to compare therapeutic techniques, the advancement of endovascular techniques has led to many trials suggesting that endovascular management of TASC II C and D lesions is a potential alternative treatment to open strategies. It is attractive for patients with high surgical risk, given the substantially less perioperative morbidity and mortality compared to ABF

This study aims to evaluate the clinical, imaging results of endovascular revascularization of the aorto-iliac sector in comparison with aortobifemoral bypass and the hybrid approach, in patients with atherosclerotic disease of the iliac sector classified as type C and D by the TransAtlantic Inter-Society Consensus (TASC II).

Eligibility Criteria:
Inclusion Criteria:

* Patients with peripheral arterial/atherosclerotic disease of the aorto-iliac sector undergoing direct, hybrid or endovascular surgical correction with TransAtlantic Inter-Society Consensus (TASC II) type D classification(12).

  * Age \>18 years old

Exclusion Criteria:

* Synchronous aortoiliac aneurysmatic/ectasic disease (aorta AP diameter \>25 mm)
The Effect of Related Blood Markers on Diabetic Peripheral Neuropathy

The goal of this observational study is to explore the relationship between related blood indicators and diabetic peripheral neuropathy(DPN).

This is a multicenter study(approximately four) with over 1000 subjects.Clinical data were collected by consulting the patient's electronic history. The data included demographic information, blood biochemical markers and electromyography. All participants provided their written informed consent to participate in this study.The study protocol was approved by the Ethics Committee of the First Affiliated Hospital of Wenzhou Medical University(KY-2022-R009).

Eligibility Criteria:
Inclusion Criteria:

* patients who had undergone nerve conduction examination by electromyography.

Exclusion Criteria:

* pregnancy and lactation; chronic liver disease, kidney disease, arrhythmias, malignant diseases, severe respiratory diseases, heart failure, and acute infections;
* patients with alcohol abuse; history of Autoimmune liver disease, liver disease or abnormal liver function at baseline;
* parathyroid diseases (including hyperthyroidism and hypothyroidism);
* pancreatitis, pancreatectomy or any transplant;
* patients with malignancy and any serious concomitant disease limit the existence of life expectancy
The Effect of Propofol Infusion on Total Antioxidant Status During Tourniquet-Induced Ischemia-Reperfusion Injury

The release of tourniquet produces reactive oxygen species which can cause injury. Propofol is chemically similar to phenol-based free radical scavengers.

Plasma total antioxidant capacity is a well-established marker of the overall protective effect of antioxidants in body fluids.The aim of the study is to investigate the effects of propofol on ischemia-reperfusion injury in total knee arthroplasty (TKA).


Eligibility Criteria:
Inclusion Criteria:

* ASA I-II physical status
* Unilateral total knee arthroplasty
* Age 18 years to 80 years

Exclusion Criteria:

* Severe central nervous system disorders
* Severe cardiopulmonary,renal,metabolic, or hepatic disease,
* Blood volume deficits,
* Coagulopathy,
* Allergy to local anesthetics,
* Peripheral neuropathies,
* Body mass index \> 35,
* History of antioxidant drug use
COVID-19 in Patients With Pre-existing Cirrhosis (COVID-Cirrhosis-CHESS2002): A Multicentre Observational Study

COVID-19 pandemic with SARS-CoV-2 infection has become a global challenge. Though most cases of COVID-19 are mild, the disease can also be fatal. Patients with liver cirrhosis are more susceptible to damage from SARS-CoV-2 infection considering their immunocompromised status. The spectrum of disease and factors that influence the disease course in COVID-19 cases with liver cirrhosis are incompletely defined. This muilticentre observational study (COVID-Cirrhosis-CHESS2002) aims to study the clinical characteristics and risk factors associated with specific outcomes in COVID-19 patients with pre-existing liver cirrhosis.

Coronavirus disease 2019 (COVID-19) pandemic with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection has become a global challenge. Though most cases of COVID-19 are mild, the disease can also be fatal. Patients with liver cirrhosis are more susceptible to damage from SARS-CoV-2 infection considering their immunocompromised status. The spectrum of disease and factors that influence the disease course in COVID-19 cases with liver cirrhosis are incompletely defined. This muilticentre observational study (COVID-Cirrhosis-CHESS2002) aims to study the clinical characteristics and risk factors associated with specific outcomes in COVID-19 patients with pre-existing liver cirrhosis.

Eligibility Criteria:
Inclusion Criteria:

* 1) Aged 18 or above;
* 2) Laboratory-confirmed COVID-19 infection;
* 3) Pre-existing liver cirrhosis based on liver biopsy or clinical findings.

Exclusion Criteria:

* 1) Pregnancy or unknown pregnancy status.
TaxXel: Taxotere and Xeloda in Esophageal Cancer

This is an open label, non-randomised, multicentre phase 1-2 study with a fixed dose of Taxotere in combination with Xeloda which is dose escalated during the first phase of the study (modified Fibonacci design) and fixed during the second phase.

The primary objective of the phase 1 part is to define the dose recommended for the Phase II part of the study. The primary objective is to determine the response rate.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed squamous cell carcinoma or adenocarcinoma of the oesophagus or cardia.
* Inoperable metastatic disease
* Performance status (WHO) of 0-2
* Measurable disease.
* Adequate hematological, liver and renal function.
* Signed informed consent.

Exclusion Criteria:

* CNS metastases
* Symptomatic peripheral neuropathy equal to or greater than NCI grade 2.
* Other concomitant serious illness or medical condition.
* Past or current history of malignant neoplasm other than oesophageal carcinoma.
* \<18 years of age. Pregnant or lactating patients.