cyrilzakka/clinical-trials huggingface dataset:
Combination Chemotherapy or Observation Following Surgery in Treating Infants With Neuroblastoma

RATIONALE: Sometimes neuroblastoma will regress without treatment, but sometimes additional treatment may be necessary. Giving more than one chemotherapy drug after surgery to remove the tumor may kill more tumor cells.

PURPOSE: Phase II trial to study combination chemotherapy or observation following surgery in treating infants with neuroblastoma.

OBJECTIVES: I. Determine the incidence of spontaneous regression of localized neuroblastoma in infants. II. Determine how many infants with neuroblastoma do not need chemotherapy. III. Evaluate the time course of regression by radiologic criteria and catecholamine metabolites. IV. Determine the reliability of risk estimation by molecular characteristics (N-myc amplification, CD44, del 1p) compared to clinical criteria. V. Evaluate whether reduced therapeutic toxicity results in a decrease in treatment-related deaths. VI. Correlate cytostatic drug levels with chemotherapy side effects.

OUTLINE: All patients undergo resection of the primary tumor and N-myc determination within 6 months of age, unless critically ill, then are treated according to risk. Patients with amplified N-myc or with indeterminate N-myc amplification but with other risk features are treated per protocol GER-NB90. Stage 4S patients who are critically ill or thrombocytopenic receive doxorubicin, vincristine, and cyclophosphamide over 7 days. Patients with no amplification of N-myc are observed for 6 months (until between 12 and 18 months of age). Patients with minimal residual disease (less than 10% or diameter no greater than 2-5 mm) continue observation, while those with residual disease but no disease progression undergo repeat biopsy. Patients whose biopsy indicates tumor regression also continue observation. All other patients, including those with disease progression, are treated per protocol GER-NB90.

PROJECTED ACCRUAL: 36-44 patients per year will be accrued (22-27 patients with stages 1-3, 8-10 patients with stage 4S, and 6-7 patients with stage 4 neuroblastoma).

Eligibility Criteria:
DISEASE CHARACTERISTICS: See General Eligibility Criteria

PATIENT CHARACTERISTICS: See General Eligibility Criteria
Slider Versus Tensioner Neural Mobilization in Diabetic Peripheral Neuropathy

Neurodynamics, i.e., the mobilization of the peripheral nervous system, is a physical approach to the treatment of pain; the method relies on influencing pain physiology via mechanical treatment of neural tissues and the non-neural structures surrounding the nervous system. Neural mobilization (NM) is used to treat various disorders of the nervous system concerning the length and mobility of peripheral nerves, as the nerve mobilizing refers to techniques that help to reestablish motion between a nerve and its surrounding soft tissues, thus to treat the nerves that have become entangled within the soft tissue, as it leads to tension release on a nerve by stretching and pulling one end of the nerve during keeping the other end in a relaxed state.

The neurodynamic technique both sliders and tensioners results in changes of the mechanical or physiological function of nerve tissues along with the interface; restoring pressure gradients, relieving hypoxia and pain resulting in reducing associated symptoms.

Through clinical reasoning the nervous system seems to be the logical place for treatment and explanations and previous descriptions of this method have clarified the overall impact on quality of life in diabetic peripheral neuropathy but it doesn't discuss which technique of neural mobilization is more effective and its effects on diabetic peripheral neuropathic population. Within this reasoning it is important to determine which neurodynamic technique is more effective in improving quality of life and reduce pain in patients with diabetic peripheral neuropathy.

Eligibility Criteria:
Inclusion Criteria:

* Patient having≥12score on Self report Leads Assessment of Neuropathic Symptoms and Sign
* Patients with lower limb pain ≥4 to ≤7 on NPRS

Exclusion Criteria:

* Diabetic foot ulcer
* Complex regional pain syndrome
* Infection in lower limb
* Lower extremity amputation
* Discogenic pain
* Restricted joint deformity
* Dependency on chemical or drugs
* Pregnancy
Follow-up Study of the Effectiveness of Virtual Reality Therapy in MS Patients

Different therapies can improve clinical and motor symptoms of multiple sclerosis (MS) similarly, but studies comparing the effects of different exercise therapies on clinical and motor outcomes are scant. We compared the effects of exergaming (EXE), balance (BAL), cycling (CYC), proprioceptive neuromuscular facilitation (PNF), and a standard care wait-listed control group (CON) on clinical and motor symptoms and quality of life (QoL) in people with MS (PwMS).

Methods: PwMS (n = 68, 90% female; age, 47.0 yr; Expanded Disability Status Scale score 5-6) were randomized into five groups. Before and after the interventions (five times a week for 5 wk), PwMS were tested for MS-related clinical and motor symptoms (Multiple Sclerosis Impact Scale-29 (MSIS-29), primary outcome), QoL (EuroQol Five Dimensions Questionnaire), symptoms of depression, gait and balance ability (Tinetti Assessment Tool), static and dynamic balance and fall risk (Berg Balance Scale), walking capacity (6-min walk test), and standing posturography on a force platform.

Patients were followed up for 2 years after 5 weeks of intensive care. Tests are performed every six months.


Eligibility Criteria:
Inclusion Criteria:

* Multiple Sclerosis
* instability problem

Exclusion Criteria:

• Severe heart problems, severe demeanor, alcoholism, drug problems
Effect of Itraconazole on the Pharmacokinetics of SHR6390 in Healthy Subjects

The primary objective of the study is to evaluate the effect of itraconazole on pharmacokinetics of healthy Chinese adult subjects after oral administration of SHR6390 tablets. The secondary objective of the study is to evaluate the safety of SHR6390 alone and when co-administered with itraconazole. The exploratory objective of the study is to explore the effect of SHR6390 related metabolic enzymes and transporter gene polymorphisms on the pharmacokinetics of SHR6390.


Eligibility Criteria:
Inclusion Criteria:

1. Sign the informed consent before the trial, and fully understand the trial content, process and possible adverse reactions;
2. Ability to complete the study as required by the protocol;
3. Healthy male or female subjects aged 18 to 45 (including 18 and 45) at the date of signing the informed consent;
4. Male body weight ≥ 50 kg, female body weight ≥ 45 kg, and body mass index (BMI) within the range of 19 \~ 26 kg /m2 (including 19 and 26);

Exclusion Criteria:

1. Allergic constitution;
2. History of drug use, or drug abuse screening positive;
3. Alcoholic or often drinkers;
4. Left ventricular ejection fraction (LVEF) \<50% by echocardiography;
5. A clear medical history of important primary organ diseases such as nervous system, cardiovascular system, urinary system, digestive system, respiratory system, metabolism and musculoskeletal system.
6. Abnormal clinical laboratory tests and clinical significance judged by the investigator or other clinical findings showing the following diseases, including but not limited to gastrointestinal tract, kidney, liver, nerve, blood, endocrine, tumor, lung, immune, mental or cardiovascular and cerebrovascular diseases.
Randomized Controlled Trial of Human Papillomavirus Testing in Primary Cervical Cancer Screening

Human papillomavirus (HPV)-based cervical screening is known to increase sensitivity for detection of high-grade cervical intraepithelial neoplasia (CIN). Randomized trials of longitudinal efficacy are required to assess whether these gains represent overdiagnosis or a protective effect.

Methods: A total of 12527 women, aged 32-38, attending population-based invitational screening in Sweden were randomized 1:1 to HPV test and cytology (intervention arm) or cytology only (control arm). HPV-positive women were invited for a second HPV test at least one year later and women with type-specific persistent infections were then invited to colposcopy. A similar number of random double-blinded procedures are performed in the control arm. Women are followed with comprehensive registry-based follow-up. Primary outcome is the relative rates of CIN grade 2 or worse (CIN2/CIN3+) found in subsequent screening. Secondary outcomes are the relative rates of CIN2/CIN3+ found in the aseline screening and outcomes stratified by grade of CIN (CIN 2 or CIN3+).


Eligibility Criteria:
Inclusion Criteria:

* Women aged 32-38 years old
* Attending the Swedish population-based organised cervical screening program

Exclusion Criteria:

* Not providing informed consent
Prematurity-Related Ventilatory Control: Role in Respiratory Outcomes

The objective of this common multicenter protocol is to test the hypothesis that algorithmic tools using clinical Neonatal Intensive Care Unit (NICU) cardiorespiratory monitoring data can detect ventilatory control instability and predict chronic and acute respiratory consequences of ventilatory control instability and autonomic dysregulation.


Eligibility Criteria:
Inclusion Criteria:

* Neonatal Intensive Care Unit patient on cardiorespiratory monitor which has been configured to collect data to store for this study
* \< 29 wks Gestational Age
* \< 1 wk Chronological

Exclusion Criteria:

* Unlikely to survive or decision not to pursue full care
* Major congenital or chromosomal anomaly
The Effect of the Training Program on Increasing Sleep Quality in Pregnancy to Maternal Sleep Quality

The aim of this study is to compare the control group and the intervention to be applied to the education program used to increase sleep quality in nulliparous women.

The study was a randomized controlled training intervention study in the pre-test and post-test order. The population of the study consisted of nulliparous pregnant women who applied to the Konya Dr. Ali Kemal Belviranlı Maternity and Children Hospital Pregnancy School and met the criteria for inclusion in the study at time of the study. Sample size was calculated with G \* Power 3.0.10 program with an effect size of 0.3 (medium effect level) and a power of 80%. A total of 180 pregnant women were identified as 90 in the intervention group and 90 in the control group. Considering that data will be lost due to reasons such as discontinuation and exclusion criteria during pregnancy 10% more of the determined number was included in the study and the sample size was calculated as 198 pregnant women and 252 pregnant women were reached during the study. 36 pregnant women in the intervention group and 35 pregnant women in the control group were excluded from the study for different reasons and the study was completed with 181 pregnant women (90: control: 91). The groups were determined by randomization. During the conduct of the study, all pregnant women who applied to the pregnant school and met the criteria for participation in the study were recorded in the pre-training registry and numbered in the order of registration. Every week because of differences in the number of pregnant women who attended the school participating women were divided into two groups using a random number table created in the program via the computer itself. The purpose of the study was explained to pregnant women, informed consent form and data collection tools of the study were collected by face to face interview technique. In the first interview to all pregnant women; Personal Information Form, Course Information Form, Pittshburg Sleep Quality Index (PUKI) and General Self-Efficacy Scale were applied. Pregnant women in the intervention group were given a two-session training program to improve sleep quality and "Sleep Guide" and "Safe Baby Sleep Conditions Brochure". Pregnant women in the control group were subjected to routine practice without any training given by the researcher. Four weeks after the completion of the sleep training, all pregnant women were contacted by telephone and the data collection tools were applied for the second time and the final test applications were completed. After completion of the data collection process made a new plan for training to improve the quality of sleep to pregnant women in the control group and the "Sleep Guide" and "Safe Baby Sleep Conditions Brochure" is given.

Eligibility Criteria:
Inclusion Criteria:

* pregnant women
* between 28 and 32 gestational weeks

Exclusion Criteria:

* under 18 years old
Comparison of Reversal of Neuromuscular Blockade With Sugammadex Versus Neostigmine Plus Glycopyrolate in Patients Undergoing Burn Surgery

The purpose of this study is to learn if there is a difference in recovery time when using sugammadex versus neostigmine. The researchers also hope to add further knowledge and data to the safety of using sugammadex in burn patients who are hypermetabolic.


Eligibility Criteria:
Inclusion Criteria:

* Undergoing burn surgery under general anesthesia

Exclusion Criteria:

* Patients without a non-burned upper extremity
* Renal insufficiency or failure
* Sensitivity or hypersensitivity reaction to sugammadex
* Liver impairment, neuromuscular degenerative disease or dependence on drugs or alcohol
Rational Use of Personal Protective Equipment During COVID-19 Pandemic

This study aims to improve the personal protective equipment (PPE) used while treating patients with COVID-19, to protect staff and avoid cross-infection of patients. Protecting staff from infection during the Covid pandemic is critical to maintaining health services. Mistakes in using protective equipment (PPE) are the commonest avoidable factor in staff becoming infected at work. Recently, intensive care doctors have also reported an increase in the spread of dangerous multi-resistant bacteria between patients, which appears likely to be transmitted between patients by Level 2 PPE worn by staff (specifically gown sleeves). This study therefore seeks to develop and test a new protocol to decrease cross-infection risks whilst using Level 2 PPE.


Eligibility Criteria:
Inclusion Criteria:

1. NHS staff and works in the Adult Intensive Care Unit, Neuro Intensive Care Unit or Cardio-thoracic Intensive Care Unit
2. Trained in the correct use of Level 2 PPE according to current guidance
3. Trained in ICU COVID19 Intubation and Proning protocols
4. Willing and able to give informed consent for participation in the study.

Exclusion Criteria:

1. taking any medication which can cause photosensitivity reactions in the preceding 3 months
Single Center Registration Study on HER2 Expression and Clinical Pathological Characteristics in Prostate Cancer

This study is a single center, non-interference, retrospective registration study: HER2 testing and disease information collection were conducted on patients diagnosed with prostate cancer and able to obtain tumor tissue in our hospital from January 2018 to July 2023. Statistical analysis was conducted on the collected information to analyze the expression of HER2 in Chinese prostate patients and the correlation between HER2 and disease type.

1. To explore the expression of HER2 protein in prostate cancer patients admitted to Qilu Hospital of Shandong University, especially the expression rate of HER2 protein under different pathological characteristics (age, TNM grade, primary and metastasis), and to explore the correlation between HER2 protein expression level, efficacy, and prognosis based on patient clinical information.
2. (1) Main Purpose

Analyze the expression of HER2 in prostate cancer patients admitted to Qilu Hospital of Shandong University.

(2) Secondary purpose

The expression of HER2 protein under different clinical and pathological characteristics (age, TNM grade, primary, and metastasis).

3.Main indicators:

The expression of HER2 in prostate cancer patients.

Secondary indicators:

1. The correlation between HER2 expression (IHC0/1+/2+/3+) and disease characteristics in locally advanced or metastatic prostate cancer patients;
2. The distribution of HER2 expression in different ages, different parts, different degrees of differentiation, and different TNM stages; Evaluate the expression of primary and metastatic lesions in patients with metastasis

Eligibility Criteria:
Inclusion Criteria:

* 1. Prostate cancer patients confirmed by histopathology in our hospital from January 2018 to July 2023;

  2. Men aged ≥ 18 years old;

  3. The expected survival time is greater than 12 weeks;

  4. The KPS functional status score is greater than 60, and the ECOG status score is 0-2 points;

  5. The subjects voluntarily joined this study, signed an informed consent form, had good compliance, and cooperated with follow-up.

Exclusion Criteria:

- 1. Those who have been diagnosed with tumors in other parts, such as lung cancer, liver cancer, stomach cancer, colorectal cancer, breast cancer, etc. (except for cancer in situ or non melanoma skin cancer, or combined tumors with low recurrence probability within a few years);

2. According to the researcher's judgment, there are other patients who are not suitable for inclusion.
Effects of Nicotinic Acid Plus Simvastatin Versus Simvastatin Alone on Carotid and Femoral Intima-Media Thickness in Patients With Peripheral Artery Disease (NASCIT)

Dyslipidaemia is characterized by low plasma levels of high-density lipoprotein cholesterol (HDL-c), elevated triglycerides and an increase in low density lipoprotein (LDL-c) particles, and has been unequivocally established as a most important cardiovascular risk factor. While statins are effective in reducing plasma levels of LDL-c, these drugs have only modest effects on raising HDL-c (typically by less than 10%), even with aggressive statin therapy. However, increasing evidence suggests that low HDL-c might be at least as relevant as high LDL-c in promoting the development and progression of atherosclerosis. The beneficial effect of raising HDL-c on clinical outcome has already been demonstrated by several studies.

Nicotinic acid is the most potent agent available for raising plasma levels of HDL-c by up to 29% at clinically recommended doses, and substantially lowers triglycerides and LDL-c. Furthermore, nicotinic acid is also the most potent lipid lowering agent available that reduces Lp(a), an independent marker of cardiovascular risk. In a recent study patients with coronary artery disease had a 21% increase in HDL-c and a 13% decrease in triglycerides, and these beneficial effects on lipid status may have contributed to a stabilization or regression of carotid intima-media-thickness (IMT).The impact in patients with advanced atherosclerosis like peripheral artery disease (PAD) in unknown.

The investigators hypothesized that nicotinic acid in addition to statin therapy may inhibit progression of peripheral arterial atherosclerosis. Therefore, the aim of the present randomized controlled trial is to investigate the effects of nicotinic acid (daily dose starting with 500 mg, up to 2000mg) in addition to simvastatin (40 mg daily) versus simvastatin (40mg daily) monotherapy in patients with low serum HDL-C levels and PAD with respect to changes of carotid and femoral IMT, changes of patients´ lipid status and occurrence of major adverse cardiovascular events (MACE).


Eligibility Criteria:
Inclusion Criteria:

* PAD defined as an ABI ≤0.9 or \>1.3 in patients with low serum HDL cholesterol levels (\<45mg/dL in men, \<55 mg/dL in women)

Exclusion Criteria:

* Elevated liver enzymes (above 2 times the normal level)
* Skeletal muscle myopathy or elevated serum CK levels
* Allergy or hypersensibility to either statins or nicotinic acid
* Women of childbearing potential
Observation of Therapy With Micardis® (Telmisartan) in Patients With Essential Hypertension in Hospitals

The aim of the observational study was to supplement the data on efficacy, safety and tolerability of telmisartan under daily conditions in hospitals


Eligibility Criteria:
Inclusion Criteria:

* Patients with diagnosis of essential hypertension
* Minimum age of 18 years

Exclusion Criteria:

* NA
Self-pressurised Air-Q With Blocker Versus Baska Mask in Low Risk Female Patients Undergoing Ambulatory Surgery.

Supraglottic airway devices (SGAs) are very commonly used during anesthesia but structural vulnerability to airway morbidity and issues about cuff pressure still concern anesthesiologists. There have been controversial results regarding optimal intra-cuff pressure in various types of cuffed supraglottic airways. When the supraglottic cuff pressure is more than the mucosal perfusion pressure, it is likely to either cause postoperative pharyngo-laryngeal symptoms like sore throat (dysphagia, dysphonia) or cause local mucosal trauma and nerve injuries. Supraglottic airway devices with non-inﬂatable cuff have advantages in omitting the cuff pressure monitoring and reducing potential pharyngo-laryngeal complications.

Self-pressurizing Air Q blocker is the latest version. It has a drain tube through which a suction tube is passed. There is an inflatable cuff at the end of this tube. On inflation, the cuff seals the esophageal opening into the stomach, preventing any regurgitation of stomach contents. Instead of the pilot balloon and inﬂating cuff, the air-Q SP with blocker has a communication oriﬁce at the junction of the peri-glotic cuff and the airway tube. This communication between two spaces enables the cuff to dynamically regulate intra-cuff pressure depending on airway pressure. This distinguishing feature of the air-Q SP may result in reduced risk for airway morbidities related to cuff hyperinﬂation.

The Baska mask is a novel supraglottic airway device with a non-inﬂatable cuff, an oesophageal drainage inlet and side channels to facilitate aspiration of gastric contents, and an integrated bite-block. It was revealed that the baska mask is relatively easy to insert, provided a high-quality seal with the glotic aperture and the incidence of throat discomfort appeared low.

To our knowledge, and after searching in previous literature, no previous studies have compared the Air-Q SP with blocker with Baska mask; another supraglottic airway devices with non-inﬂatable cuff.


Eligibility Criteria:
Inclusion Criteria:

* Female patients between the age group of 18 and 50 years,
* ASA class I and II,
* undergoing elective surgeries,
* with Ganzouri airway score less than 4

Exclusion Criteria:

* ASA III - V patients.
* Airway score ≥ 4 according to El-Ganzouri Airway Scoring System.
* Patients with respiratory or pharyngeal pathology.
* Patients allergic to any drugs in the protocol.
* Obese patients with body mass index ≥ 40.
* Patients known to have risk of gastric aspiration, gastro-esophageal reflux disease, hiatus hernia or previous upper gastrointestinal tract surgery.