cyrilzakka/clinical-trials huggingface dataset:
The Effect of Immunological Heterogeneity of Tumor Microenvironment in the Prognosis of Gastric Cancer

The purpose of this study is to explore the effect of immunological heterogeneity of tumor microenvironment in the short-term outcome and long-term outcome of patients with gastric cancer.

A prospective cohort study will be performed to explore the effect of immunological heterogeneity of tumor microenvironment in the short-term outcome and long-term outcome of patients with gastric cancer. The evaluation parameters are perioperative clinical efficacy, postoperative complications, and 3-year survival and recurrence rates.

Eligibility Criteria:
Inclusion Criteria:

1. Age from 18 to 80 years
2. Histology confirmed gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy.
3. Clinical stage: cTNM: stage I or above at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Eighth Edition
4. Performance status: Eastern Cooperative Oncology Group (ECOG) ≤ 2 (normal to symptomatic but in bed less than half the day)
5. Clinically fit for gastric cancer surgery, i.e. adequate renal, hepatic, hematologic, and pulmonary function.
6. Written informed consent

Exclusion Criteria:

1. Women during pregnancy or breast-feeding
2. Severe mental disorder
3. History of previous gastrectomy, endoscopic mucosal resection, or endoscopic submucosal dissection
4. History of other malignant diseases within the past five years
5. History of unstable angina or myocardial infarction within the past six months
6. History of a cerebrovascular accident within the past six months
7. History of continuous systematic administration of corticosteroids within one month
8. Requirement of simultaneous surgery for other diseases
9. Emergency surgery due to complication (bleeding, obstruction, or perforation) caused by gastric cancer
10. Forced expiratory volume in 1 second (FEV1)\<50% of predicted values
11. Inclusion in another clinical trial
Letrozole Pretreatment With Misoprostol Versus Misoprostol Alone in Missed Abortion

This study compares the success rate of letrozole and misoprostol versus misoprostol alone for medical termination of first-trimester pregnancy.

According to the American college of obstetricians and gynecologists (2005), medical abortion is an acceptable alternative for surgical procedures in pregnant women with gestational age of less than 49 days based on the last menstrual period

Oral or vaginal misoprostol causes complete abortion in almost 85% of cases within seven days before the 12th week

letrozole administration with misoprostol raises the rate of complete abortion

Eligibility Criteria:
Inclusion Criteria:

* Gestational age less than 64 days gestation (\<9 wks).
* Hemoglobin \>10 g/dL.
* BMI between 18.5 kg/m2 and 25 kg/m2.
* Missed abortion.

Exclusion Criteria:

* Molar pregnancy.
* Fibroid uterus.
* Uterine anomalies.
* Coagulopathy.
* Medical disorder that contraindicate induction of abortion (e.g. heart failure).
* Previous attempts for induction of abortion in the current pregnancy.
* Allergy to misoprostol or letrozole.
* Scared uterus (previous myomectomy, cesarean section, hysterectomy and ruptured uterus).
Medical and Health Economic Benefit of Oral Nutritional Supplements (ONS) in Ambulant Patients

The aim of this study is to assess the benefit of a 3-month intervention with oral nutritional supplements (ONS) in older ambulant patients with reference to functional limitations and quality of life as well as the consumption of health care resources.

Study participants are assessed upon discharge from the hospital and again after 3 months. Upon discharge all patients receive nutrition counselling with special focus on an energy rich diet. Additionally, the intervention group receives ONS. The investigators hypothesize an improvement in functional limitations and health economic benefits due to the post-hospital nutritional intervention.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 60 years
* Informed written consent
* Independent community dwelling after discharge
* Existing or risk of malnutrition
* Normal cognitive status according to Mini-Mental State Examination (MMSE ≥ 24 points)
* Life expectancy of \> 3 months according to treating doctor
* No severe heart disease (New York Heart Association (NYHA) functional classification of 3+), liver disease (Child Pugh Score = A, B) or kidney insufficiency (glomerular filtration rate \< 30 ml/min)
* No chemo or radiation therapy
* No derailed diabetes mellitus or metabolic decompensation

Exclusion Criteria:

* Age \< 60 years
* Lack of informed written consent
* Dependent living conditions after discharge
* No risk of malnutrition
* Low cognitive status according to Mini-Mental State Examination (MMSE \< 24 points)
* Life expectancy of \< 3 months according to treating doctor
* Severe heart disease (New York Heart Association (NYHA) functional classification of 3+), liver disease (Child Pugh Score = C) or kidney insufficiency (glomerular filtration rate \< 30 ml/min)
* Chemo or radiation therapy
* Derailed diabetes mellitus or metabolic decompensation
Internal Brace Augmented Anterior Inferior Tibiofibular Ligament Repair: Post-operative Syndesmotic Volumes.

Over the course of a year from the start of the research study, twenty subjects will be randomized evenly into one of two groups after an informed consent is obtained: a traditional tight rope fixation group or a tight rope fixation with an anterior inferior tibiofibular ligament (AITFL) repair augmentation with an internal brace group. Postoperative reduction was assessed by 3D volumetric ratios and measured by weight-bearing CT at 6-weeks and 3-months post-operation. Patient Reported Outcomes (PROs) were collected preoperatively, and at 6-weeks, 3-months, 6-months, and 1-year post-operation and included the Foot and Ankle Outcome Score and the 36-Item Short Form Survey Instrument (RAND-36) . Differences in volumetric ratios and PROs were evaluated between groups and time periods.


Eligibility Criteria:
Inclusion Criteria:

* patients who fit the study injury list

Exclusion Criteria:

* smokers
* prior surgery on ankle
* bi-lateral surgery
* recent participation in another study within the last 90days
Impact of Metformin in Rectal Cancer Patients

Design: Prospective, randomized controlled clinical trial Setting: at Minia University Hospital and Minia Oncology Institute. Condition: Colorectal cancer.

To be eligible for participation, patients must meet the following criteria:

1. Histologically confirmed diagnosis of rectal adenocarcinoma.
2. Age starting from 18 and older.
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
4. Adequate organ function (renal, hepatic, and hematological)
5. Signed informed consent.

Patients will be randomized into two groups:

Group A: Patients will receive standard chemoradiotherapy(CRT).

Group B: Patients will self-administer 1000mg of metformin twice daily by mouth:

1. beginning 1-2 weeks before standard CRT.
2. during standard CRT.
3. until 30 days after the end of standard CRT.


Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed diagnosis of rectal adenocarcinoma.
2. Age starting from 18 and older.
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
4. Adequate organ function (renal, hepatic, and hematological)
5. Signed informed consent.

Exclusion Criteria:

1. Metastatic disease.
2. Contraindications to metformin.
3. Significant comorbidities or medical conditions that may interfere with study participation. (D.M, PCO,..)
4. eGFR less than 30 mL/min.
5. Pregnant or breastfeeding women.
Survival and Predictive Factors of Clinical Outcome in Patients With Acquired Brain Injury

The prediction of the final neurological and functional status of patients with acquired brain injury remains very uncertain despite the findings of current medicine. The aim of the study is to evaluate the clinical outcomes in patients with the most severe degree of brain injury hospitalized in the long-term intensive care unit of the Military University Hospital Prague.

The prediction of the final neurological and functional status of patients with acquired brain injury remains very uncertain despite the findings of current medicine. Current medical knowledge is particularly limited in patients with the most severe brain injury who had to be tracheostomized and admitted to long-term intensive care unit. In the Czech Republic, there is a complete lack of data on clinical outcomes in these patients.

Some recent studies has not confirmed the long-standing better outcome in patients with traumatic brain injury compared to non-traumatic etiologies. The aim of the study is to evaluate the clinical outcomes in patients with the most severe degree of brain injury hospitalized in the long-term intensive care unit of the Military University Hospital Prague.

Eligibility Criteria:
Inclusion Criteria:

* Acquired brain injury
* Initial Glasgow Coma Scale (GCS) score less than 8 points
* Tracheostomy for persistent impairment of consciousness

Exclusion Criteria:

* none
Location of GLP-1 Release

Background: Physicians do not have a unified, scientifically tested theory of causation for obesity and its comorbidities, nor do they have explanations for the mechanics of the metabolic/bariatric surgery procedures. Integral to proffered hypotheses are the actions of the hormones glucagon-like peptide (GLP-1), peptide YY (PYY), and leptin.

Study objective: To obtain blood levels of GLP-1, PYY, and leptin after stimulation of the terminal ileum and cecum by a static infusion of a food hydrolysate in morbidly obese patients undergoing a duodenal switch procedure.

Methods: Plasma levels of GLP-1, PYY, and leptin were obtained at 0, 30, 60, 90, and 120 minutes after instillation of 240 ml of a food hydrolysate into the ileum or cecum.


Eligibility Criteria:
Inclusion Criteria:

* Any patient who was qualified and approved for bariatric surgery and elected to undergo open duodenal switch procedure.

Exclusion Criteria:
Effects of Foundation and Functional Inspiratory Muscle Training in Non-Specific Chronic Low Back Pain

This study was planned to examine the effects of basic and functional respiratory muscle training on pain, disability level, and functionality. In this study, participants will be randomly divided into 3 groups. The first group will be treated with physical therapy applications applied in state hospitals for 10 weeks. The second group will receive basic respiratory muscle training treatment in addition to physical therapy in state hospitals. The third group will receive respiratory muscle training with exercise in addition to physical therapy in state hospitals. Evaluations will be made before the first session, after the 30th session, in the 3rd month, in the 6th month, and in the 1st year. There is no interventional method in the evaluations. Pain intensity, disability level, physical activity status, quality of life, fear of movement, pain catastrophizing, anxiety and depression levels will be questioned with scales. In physical measurements, participant's aerobic capacity will be measured with the 2-Minute Walk Test, participants's flexibility with the sit-and-long test, participants's respiratory muscle strength with the MIP/MEP device, participants's core endurance with the trunk flexor muscle endurance test, participants's lower and upper extremity muscle strength with a handheld dynamometer, participants's postural control with the Biodex balance device, and participants's muscle thickness with an ultrasound.


Eligibility Criteria:
Inclusion Criteria:

* Volunteering to participate in the study,
* Being between the ages of 18-65,
* Having low back pain that has been ongoing for at least 3 months (12 weeks),
* Having a Visual Analog Scale (VAS) of pain intensity of ≥3,
* Being right-hand dominant.

Exclusion Criteria:

* Not volunteering to participate in the study,
* Having a history of cancer,
* Having a spinal infection,
* Having a rheumatological condition,
* Having a spinal fracture,
* Having red flag signs (sudden and unexpected weight loss, fever, etc.)
* Having a psychological disorder,
* Having a previous spinal surgery,
* Having radiculopathy (neuropathic pain along the lower extremity due to nerve root compression),
* Not continuing home exercises more than 80%,
* Having an anatomical and congenital abnormality
Feasibility and Effectiveness of Virtual Reality & Use of Body Weight Support Treadmill Training in Parkinson's Disease

The primary hypothesis of the investigators is that a virtual reality system combined with physical activity provided on a body weight support treadmill training would change clinical parameters of balance and mobility in people with Parkinson's Disease


Eligibility Criteria:
Inclusion Criteria:

* idiopathic Parkinson Disease diagnosis
* age under 80 years
* severity of disease rated 2 or 3 at Hoehn \& Yahr scale

Exclusion Criteria:

* impaired cognitive functioning: score less than 24 on the Mini Mental State Examination
* neurologic conditions in addition to Parkinson Disease that may affect motor function and other medical conditions likely to interfere with the ability to safely complete the study protocol
* severe Levodopa dyskinesia
* pregnancy
The Danish Version of the Surgical Fear Questionnaire

The aim of this translation and validation study is to make the The Dutch Surgical Fear Questionnaire (SFQ) applicable in adult Danish speaking patients referred to surgery.

After succesful translation of the SFQ, 200 adult patients referred to surgery at Gødstrup Hospital will be invited to answer the SFQ as well as two other questionnaires for the validation: The Pain Catastrophizing Scale (PCS) and The Hospital Anxiety and Depression Scale (HADS).

Statistical analysis will be performed to assess the correlation between the scales and thus the validity of the SFQ.

Some of the instruments for assessing surgical fear are the Amsterdam Preoperative Anxiety and Information Scale (APAIS), the Hospital anxiety and depression scale (HADS), the State-Trait Anxiety Inventory (STAI) and the Visual Analog Scale assessing Anxiety (VAS-A). However, HADS, STAI and VAS-A ask questions not particular related to perioperative procedures and thus seem too generic and APAIS seems unspecific despite questions directly related to anaesthesia and the surgical procedure. The Dutch Surgical Fear Questionnaire (SFQ) was developed to be suitable for general use among all types of adult surgery patients to assess self-reported surgical fear, and to cover a broad range of short-term and long-term surgery-related fears.

The translation and validation follows the standardized multistep process outlined by Cha, Kim, and Erlen: 1) forward translation, 2) backward translation by native speakers, 3) a test of the translation in a pilot population of adults referred to surgery at Gødstrup Hospital, and 4) validation in a clinical population.

For the validation of quantitatively measured clinical variables (clinimetric validation), convergent validity will be assessed between SFQ, the Pain Catastrophizing Scale (PCS) and the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-A). The Cronbach's alpha test will be employed to assess the internal consistency of the SFQ subscales and the overall score.

Approval of the study has been obtained from the Institutional Review Board at Central Denmark Region. Informed consent will be obtained from all participants prior to inclusion.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Able to read and understand Danish
* Cognitive well-functioning
* No previously or ongoing diagnosed mental disorders
* Consent to participate in the study.

Exclusion Criteria:

* Any patient who in the opinion of the investigator does not comply with the inclusion criteria
Cost Effectiveness Analysis of a Randomized Control Trial of q3h vs. q4h Albuterol as Discharge Criteria From the Hospital for Pediatric Asthma Exacerbations

Asthma is the most common chronic condition among children, and the third leading reason for hospitalization of children in the United States. It exerts a large healthcare burden on the US with estimated annual direct healthcare cost of approximately $50.1 billion with indirect costs of $5.9 billion.

Asthma is characterized by airway inflammation and airway constriction. Albuterol and other betaagonists are first line standard of care for acute exacerbations and provide short acting smooth muscle relaxation and subsequent airway opening. The frequency of albuterol administration is dependent on the severity of the exacerbation. For hospitalized patients here at Children's Memorial Hermann (CMHH), patients may receive nebulized albuterol continuously or if the exacerbation is not as severe, receive albuterol intermittently. Intermittent albuterol frequency ranges from every two hour treatments, every three hour (q3h) treatments, or every four hour (q4h) treatments. As patients recover from their acute exacerbation, their frequency of albuterol administration is progressively titrated along this continuum. Expert consensus uses q4h albuterol as discharge criteria from the hospital. However, recent QI initiatives have studied the effect of q3h treatments as the discharge cutoff with no reported changes in safety or harm. There are no randomized controlled trials available. Furthermore, there are no economic evaluations available to see if costs saved by decreasing the length of hospital care are merely being shifted to subsequent clinic or emergency room care costs.

The investigators aim to conduct a randomized control trial to compare q3h vs. q4h albuterol as hospital discharge criteria for patients admitted for acute asthma exacerbations. The investigators also propose to conduct a costeffectiveness analysis of the trial. If the hypothesis that q3h albuterol is safe and as effective as q4h albuterol as discharge criteria, the investigators would be able to argue for a new standard of care that is more cost effective for this very costly and common disease of children in the United States


Eligibility Criteria:
Inclusion Criteria:

* Children with Primary Reason for Hospitalization of Asthma Exacerbation

Exclusion Criteria:

* Those that never needed q3h albuterol treatments
Torque Teno Virus: A Biomarker of Immunosuppression

To seek an association between Torque Teno Virus DNA titres resulting from under or over-immunosuppression in a kidney allograft recipient, Graft rejection, both cell-mediated rejection and antibody-mediated rejection, donor-specific antibodies (DSA), the incidence of BK viraemia and BK nephropathy, CMV infection or diseases and PCP infection and the number of circulating NK, B and T lymphocyte subtypes.

Balancing the adverse effects of over-immunosuppression such as infection and malignancy, to the risk of rejection, remains the central challenge for day-to-day clinical practice in transplantation. A quantitative measure of immunocompetence remains elusive, and in the absence of such markers, immunosuppression drug concentrations and clinical events, such as organ rejection, infection, malignancy etc. are used as surrogate markers of immunocompetence to guide therapy. As demonstrated in several studies, the Torque teno virus is widespread amongst the general population. In theory, if one suppresses the immune system, these viruses should multiply, resulting in a higher DNA level which can be detected by a simple blood test. Hence, the DNA level could be used as an indicator for the level of immunosuppression, along with the available blood tests to measure the level of toxicity of the said drugs.

In this research to be done at the Royal London Hospital, the investigators aim to elucidate that the Torque teno virus is widely prevalent in an ethnically diverse East London kidney transplant recipient population by conducting the viral PCR on blood samples already collected during their routine clinic visits. The population will include all kidney transplant recipients in a two-year period. The investigators will measure the correlation between the TTV DNA level and drug concentrations of the immunosuppressive medications which will elucidate how the DNA levels are affected by different drug concentrations. The investigators will then measure the correlation between the TTV DNA levels, and the common adverse outcomes experienced by the transplant recipients, namely, patient death, loss of transplant organs, transplant rejection, rates of infection, and cancers in transplant patients by collecting data from patient records. These tests will help understand whether the Torque teno virus DNA levels can be used as a marker of immunosuppression in the general population in the UK.

Eligibility Criteria:
Inclusion Criteria:

* All consenting renal transplant recipients in the study period will be included in the study

Exclusion Criteria:

* no exclusion criteria.
Intravenous and Topical Analgesics for Procedural Pain in Neonates

This study will test which type of pain medication is best for the management of pain in newborn preterm and full-term infants having a deep intravenous cannula inserted. It will compare the effectiveness of intravenous morphine alone, a local anaesthetic cream (amethocaine) alone, and both medications together. It will also determine the safety of both medications.


Eligibility Criteria:
Inclusion Criteria:

* preterm and full-term infants in the NICU requiring a percutaneous central venous catheter
* ventilatory support in the form of conventional ventilation, Continuous Positive Air Pressure (CPAP) or High Frequency Oscillation(HFO)

Exclusion Criteria:

* seizures
* receiving muscle relaxants
* skin disorders causing disruption of stratum corneum
Letrozole and Misoprostol for Early Pregnancy Loss Management

A pilot cohort study to preliminarily investigate the efficacy of pretreatment with letrozole 10 mg daily for three consecutive days followed by treatment with misoprostol 800 mcg vaginally for medical management of early pregnancy loss in a US population. Patients will be followed to assess efficacy of this treatment regimen, as well as additional interventions needed, side effects, adverse events, and patient acceptability.


Eligibility Criteria:
Inclusion Criteria:

* Able to participate in the informed consent process and provide a signed and dated consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Access to working mobile phone
* English-speaking
* Age 18 years or older
* Confirmed diagnosis of intrauterine embryonic/fetal demise or anembryonic gestation (ultrasound examination demonstrates a fetal pole without cardiac activity measuring between 5.3 and 40 mm or an abnormal growth pattern diagnostic of early pregnancy failure)

Exclusion Criteria:

* Incomplete or inevitable abortion
* Contraindication of allergy to letrozole or misoprostol
* Unable to return for clinic-based follow-up
* Twin or multiple pregnancy