cyrilzakka/clinical-trials huggingface dataset:
Energy Costs of Spasticity in Spinal Cord Injury: A Pilot Investigation

The purpose of this study is to determine if there is a relationship between spasticity and relative changes in Basal Energy Expenditure in persons with spinal cord injury.

Obesity is at epidemic proportions in the population with spinal cord injury (SCI), and is likely the mediator of the metabolic syndrome in this special population. Recent literature reviews have suggested that obesity is present in \> 67% of persons with SCI. Additionally, recent studies have demonstrated the causal relationship between adipose tissue accumulation and vascular inflammation, dyslipidemia, insulin resistance / glucose intolerance, hypertension and thromboemboli.

Obesity in SCI occurs because of acute and ongoing positive energy balance, i.e., greater caloric intake than energy expenditure. Total Daily Energy Expenditure (TDEE) in SCI is reduced primarily because of muscular atrophy and diminished muscular contraction; pharmacological treatment of spasticity possibly reduces energy expenditure (EE) even further, but has not been evaluated to date. TDEE is comprised of three components: Basal Energy Expenditure (BEE), Thermic Effect of Activity (TEA) and Thermic Effect of Food (TEF). Of the three, BEE contributes the greatest amount (65-75% TDEE) and is the most sensitive to changes in spasticity.

Dampening spasticity has been reported to increase weight gain and necessitate reduced caloric intake in a child with spastic quadriplegia. Similarly, athetosis in patients with cerebral palsy increased resting metabolic rate (RMR) as compared to control subjects with no athetotic movements. Although several studies have reported energy requirements for persons with neurodevelopmental disabilities, and even SCI, however, none have attempted to measure the metabolic effect of spasticity.

Eligibility Criteria:
Inclusion Criteria:

* C1-T10 SCI at least 1 year post injury
* Spasticity in the legs
* Veteran

Exclusion Criteria:

* Recent increase in spasticity
* Botox within 6 months
* Phenol within 2 years
* Prior surgery for spasticity
Early Identification and Prognosis Prediction of Sepsis Through Multiomics

This study aims to integrate multi-omics data and clinical indicators to reveal pathogen-specific molecular patterns in patients with sepsis and establish prognostic prediction models through multiple machine learning algorithms.

This study aims to quantify the plasma metabolome, single nucleotide polymorphisms (SNPs) of exons and immunocytokines of septic patients with different pathogen infections and prognostic outcomes. Multi-omics data, cytokines, and clinical indicators will be integrated through multiple machine learning algorithms to reveal pathogen-specific molecular patterns and multi-dimensional prognostic prediction models.

Eligibility Criteria:
Inclusion Criteria:

* Patients with sepsis or septic shock who meet the diagnostic criteria (2016 sepsis 3.0 standard);
* Age 18～85 years old.

Exclusion Criteria:

* ICU stay of the subjects less than 72 hours;
* Female subjects who are pregnant;
* The subjects not sure if infected;
* The subjects performed CPR;
* The subjects suffer from chronic renal disease;
* The subjects with incomplete clinical data.
Phase I, First-In-Human Study of TT-00920 in Healthy Subjects

This is a first-in-human, randomized, double-blind, placebo-controlled study. The primary objectives of the study were to investigate the safety and tolerability and determine the PK profiles of single ascending doses (SAD) of TT-00920 administered to healthy subjects. The secondary objectives of the study were to assess the effect of food on the PK of TT-00920 following an oral dose.

There will be 4 single-ascending-dose cohorts and 1 cohort for food effect assessment to assess the safety, tolerability, and PK profile. A pilot dose of 20 mg will be evaluated in 2 subjects (all receiving TT-00920) for safety, tolerability, and PK profile before the initiation of dose escalation.

In single-ascending-dose cohorts, 8 subjects per cohort will be enrolled and randomized to assess the safety, tolerability, and PK profile. In food effect cohort, there will be 8 subjects (all receiving TT-00920). Subjects in food effect cohort will receive 2 single dose periods (Fasted/ Fed) in an open-label, crossover design.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent must be obtained before any assessment is performed.
* Age ≥ 18 years and ≤ 55 years, male or female of non-childbearing potential (confirmed with follicle stimulating hormone \[FSH\] test. A bilateral tubal ligation is acceptable as long as there is no fertility potential).
* Body mass index (BMI) between 18 and 30 kg/m2, inclusive, and weighs at least 50 kg.
* No clinically significant findings in medical examination

Exclusion Criteria:

* Any history of clinically serious disease.
* Hypersensitivity or allergy to any of the study drugs or drugs of similar chemical classes.
* Impaired cardiac function including clinically significant arrhythmias or clinically significant abnormality in clinical test
* Subject with a history of severe visual diseases; or visual changes including flushing lights, blurry vision, color changes, or other visual changes; or abnormal finding with visual tests \[color discrimination (Ishihara test) and visual acuity (Snellen chart).
* Subject is unable to complete this study for other reasons or the Investigator believes that he or she should be excluded.
Contrast-enhanced Ultrasound With Perfluorobutane and Sulfur Hexafluoride for Hepatocellular Carcinoma

Intra-individual comparison of diagnostic performance of CEUS With perfluorobutane and sulfur hexafluoride for HCC in high-risk Individuals, and their role in the diagnostic algorithm of HCC.

The investigators would compare the diagnostic performance for HCC at high-risk individuals between both USG contrast agents.

Eligibility Criteria:
Inclusion Criteria:

* high-risk for HCC (liver cirrhosis, chronic hepatitis B)
* treatment-naive hepatic nodule (\>= 1cm) on preceding CT, MR or ultrasound

Exclusion Criteria:

* severe cardiopulmonary dysfunction
* pregnancy
* refusal to enroll study
Gait Parameters of Persons With Down Syndrome With and Without Orthotics Using GaitRite

This is a research study of persons with Down Syndrome between 2 and 80 years old who are independently walking. The purpose of this study is to see what effect orthotics have on how people with Down Syndrome walk.


Eligibility Criteria:
Inclusion Criteria:

* Down Syndrome, independent walkers

Exclusion Criteria:

* Down Syndrome, not independently walking
Second Line Oxaliplatin Based Chemotherapy Alone Versus Oxaliplatin Based PIPAC and Chemotherapy in Colorectal Peritoneal Carcinomatosis : A Phase II Randomize Mutli-centric Study

Colorectal cancer is the third most common cancer in men and second in women. It represent 345'346 new cases per year in Europe and 134'349 in the United States of America. The peritoneal cavity is the second most frequent site, after liver, for colorectal cancer relapse.Peritoneal carcinomatosis (PC) is found in approximately 5 % of patients diagnosed with colorectal cancer and 24% of patients with synchronous metastasis at the time of diagnosis. Eight percent of colorectal cancer patient will develop PC during the course of their disease .

Currently systemic chemotherapy is the standard of care for the treatment of unresectable peritoneal carcinomatosis from colorectal cancer with a median survival rate of 16.3 months Peritoneal carcinomatosis has a poor response to systemic chemotherapy due to a weak penetration of agents into the peritoneum.

A new approach of intraperitoneal carcinomatosis is now developed: Pressurized intraperitoneal aerosol chemotherapy (PIPAC) is used to deliver intraperitoneal chemotherapy. It enhances the effect of chemotherapy because of the physical properties of aerosol and pressure.

PIPAC is a safe with a 23% morbidity and tolerated technic that is now well described.

We want to conduct a study to prove or infirm the superiority of PIPAC associated with systemic chemotherapy compare to systemic chemotherapy alone in peritoneal carcinomatosis from colorectal cancer


Eligibility Criteria:
Inclusion Criteria:

* Patients 18 \< age ≤ 75 years old with Performance status (WHO) ≤ 2 Histologically evidenced synchronous or metachronous PM of a colorectal cancer with a PCI ≥ 15 (No complete resectable PC) Histologically evidenced synchronous or metachronous PM of a colorectal cancer with a PCI \< 15 + liver or pulmonary unresectable metastases PCI \< 15 but with progression at the restaging after the first line of chemotherapy Unresectable peritoneal relapse secondary to cytoreduction surgery

Exclusion Criteria:

* Patients with clinically significant ascites (\> 3000 cc)
* Pleural effusion requiring evacuation for respiratory failure
* Small bowel occlusion with no possible food intake
* Presence of comorbidities, notably serious chronic diseases or organ failure
The Therapeutic Effect of Betaine in Syringomyelia

Purpose: This clinical trial aims to evaluate the indications, therapeutic effects and side effects of betaine in refractory syringomyelia.

Primary outcome measure: The primary endpoint is the change of ASIA at week 12. The clinical efficacy is defined as ASIA increase ≥ 1 at week 12, as compared with that before betaine usage.

The pathogenesis of syringomyelia is poorly understood and duraplasty or shunting is not always effective. Although it is generally thought that syringomyelia is simply an accumulation of CSF from the subarachnoid space, the pathogenesis is likely to be more complex and may involve cellular and molecular processes.

The investigators supposed that betaine might play a key role in the pathogenesis of syringomyelia, especially post-traumatic syringomyelia(PTS), and that betaine, as an Osmotic homeostasis-related drug, would protect Osmotic homeostasis in syringomyelia.

Primary objectives: This clinical trial aims to evaluate the indications, therapeutic effects and safety of betaine in refractory syringomyelia.

Eligibility Criteria:
Inclusion Criteria:

* Contraindication to duraplasty and shunting treatment due to history or high risk of severe adverse effects,
* non-effective response to duraplasty and shunting treatment in 12 months prior to study entry.
* Estimated life expectancy must be greater than 12 months.
* Ability to understand and willingness to sign a written informed consent document, or constant caregivers who well understand and willingness to sign a written informed consent document.
* Must be able to swallow tablets

Exclusion Criteria:

* Participants have a cardiometabolic disease for which they take prescribed medications
* Evidence of tumor metastasis, recurrence, or invasion;
* History of psychiatric diseases ;
* History of seizures;
* History of arteriosclerotic cardiovascular diseases (ASCVD), e.g. stroke, myocardial infaction, unstable angina, within 6 months;
* New York Heart Association Grade II or greater congestive heart failure;
* Serious and inadequately controlled cardiac arrhythmia;
* Significant vascular disease, e.g. moderate or severe carotid stenosis, aortic aneurysm, -history of aortic dissection;
* Severe infection;
* History of allergy to relevant drugs;
* Pregnancy, lactation, or fertility program in the following 12 months;
* History or current diagnosis of peripheral nerve disease;
* Abnormal in liver and renal function;
* Active tuberculosis;
* Transplanted organs;
* Human immunodeficiency virus;
* Participation in other experimental studies.
Factors Affecting the Time to Start Postoperative Chemotherapy in Colorectal Cancer

Colorectal cancers are common tumors and have undergone a great change in the last 20 years in terms of treatment principles. Significantly improved results in local recurrence and overall survival have begun to be obtained with chemotherapy protocols given after surgery, which is the main element of the treatment system (1). It is known that postoperative chemotherapy protocols are commonly given within 6-8 weeks and this period is optimal. However, it was found that this period was prolonged in approximately 20% of these patients in the methanalysis performed (2). It has been shown that delay in applied chemotherapy causes a decrease in overall survival (3,4). The factors causing this delay have not been adequately examined in the literature. It is necessary to investigate these factors that affect the overall survival outcomes, which are the main pillars of treatment principles, and to regulate the factors that have the opportunity to improve.

In this study, our aim is to investigate the perioperative (preop-perop-postop) factors affecting the duration of postoperative chemotherapy initiation in patients with colorectal cancer treated in our hospital.


Eligibility Criteria:
Inclusion Criteria:

patients who underwent colorectal resection

Exclusion Criteria:

patients with missing data
The Cardio-Sarcopenia Study

The use of surrogate markers such as body mass index (BMI) as a target outcome of physical activity may not be appropriate in older adults who are at risk of muscle sarcopenia. In the presence of sarcopenia, reductions in body weight may lead to lower BMI values. We have previously found deleterious changes in cardiac structure and function among sarcopenic older adults, raising a possible biological syndrome of 'cardio-sarcopenia'. In this study, we will investigate the impact of physical activity on temporal changes in cardiac and skeletal muscle , and BMI, over six- to twelve month period, on older adults with this syndrome. By targeting the cardio-sarcopenic phenotype as a modifiable risk factor that may be altered by physical activity, the results will provide new knowledge into retarding deleterious consequences of cardiovascular ageing. This new target challenges the paradigm of using BMI as an anthropometric marker in health prevention. If proven, this will dramatically change primary prevention targets among older adults, justifying the use of cardio-sarcopenia as a rational anthropometric target.

This study builds upon our group's work where we characterized cardiovascular and skeletal muscle structure and function of community-based older adults. In this proposal, we will identify n=100 participants with cardio-sarcopenia phenotype. Comparing between participants with baseline low versus high levels of physical activity, we will investigate temporal changes in their cardiovascular, skeletal muscle, biomarkers and BMI data, over a six- to twelve month period. Physical activity will include subjective self-reported physical activities and objective measures of aerobic capacity. Their physical activity levels will be verified bi-monthly via physical activity and cardiac health application that measures these markers. Pertinent fluctuations in diet, lifestyle, risk factors and biomarkers will also be recorded.

Eligibility Criteria:
Inclusion Criteria:

* \>=21 years of age

Exclusion Criteria:

* Unable to provide written informed consent to participate in the study.
A Drug Utilization Study of Radium-223 in Sweden

The objective of this study is to evaluate the extent of potential off-label use of Xofigo in Sweden.


Eligibility Criteria:
Inclusion Criteria:

* Patients receiving Xofigo with data recorded at nuclear medicine centers in Sweden between 01 July 2014 and 30 June 2016 will be included in the study

Exclusion Criteria:

* Patients receiving Xofigo in a clinical trial will not be included in this study
Prevention of HPV in the School Health Service

The last ten years sexually transmitted infections (STI) have substantially increased among adolescents. STI can lead to individual suffering and have a negative effect on the future reproductive health and also increase the need for health care, thus it is important to reduce the number of STIs. HPV vaccination is included in the school-based vaccination program since 2012, a catch-up vaccination is offered to older girls and young women aged 13-25. School nurses have a key role regarding information about HPV and HPV vaccine, and the school-based vaccination program has a substantial higher coverage rate. Knowledge is an important factor associated with attitude to preventive methods against HPV. In previous studies the results indicate that young people have low awareness of HPV and the HPV vaccine. Interventions can decrease sexual risk taking and influence the intention to receive HPV vaccination and increase the use of condom.

The aim of this study is to increase primary prevention of human papillomavirus (HPV) by promoting HPV vaccination and increase condom use among upper secondary students. The aim is also to increase the knowledge about HPV, risk and prevention.


Eligibility Criteria:
Inclusion Criteria:

* First year students in upper secondary school who visit the school nurse for the regular health interview.
* Master Swedish in speech and writing.

Exclusion Criteria:

* Students with cognitive disabilities.
5 Years Follow-up Evaluation of Deterioration Kidney Biomarkers of HIV Patients

The aim of this study is to compare the biomarkers levels as IL-18, KIM-1 and Cystatin C for patients infected by HIV with failure in renal function at year 5. The main criterion will be a degradation of the glomerular filtration throughput measured. It will be compared to clinical scores of degradation risks of renal function for patients infected with HIV.

The aim of this study is to compare the biomarkers levels as IL-18, KIM-1 and Cystatin C for patients infected by HIV with failure in renal function at year 5. The main criterion will be a degradation of the glomerular filtration throughput measured. It will be compared to clinical scores of degradation risks of renal function for patients infected with HIV.

From 2011 to 2013, researchers realized a study called HIVOL, on the diagnostic performance of GFR (Glomerular Filtration Rate) estimators in patients infected with HIV. It lead to a publication in AIDS, retaken in the rational of recommendations of Infectious Diseases Society of America for the Chronic Renal Diseases support for patients infected with HIV.

235 patients were involved, for everyone researchers have a GFR measure (by Iohexol plasmatic clearance) and urinary and plasma samples.

Eligibility Criteria:
Inclusion Criteria:

* Patient affiliated or entitled to a social security scheme
* Patient HIV infected
* Patient included in the HIVOL cohort with a GFR measure available
* Patients who have given their consent in writing

Exclusion Criteria:

* Pregnant or lactating women
* Patients treated with metformin
* Patients with a known allergy, regardless the type of allergy
* Patients with a history of thyroid dysfunction
* Any biological anomaly in the selection, which in the opinion of the investigator, may indicate a contraindication to the patient's participation in this study
* Degradation recent (not older than three months) of renal function defined as the degradation of more than 25 % GFR.
* Estimated GFR of less than 15 mL / min / 1.73m2
* History of major immediate or delayed skin reaction known to the injection of iodinated contrast medium (OMNIPAQUE®)
* Manifest thyrotoxicosis
* Hypersensitivity to the active substance or to any of the excipients (OMNIPAQUE®)
* Patient who expressed his refusal to participate in the study
* Patient justice under protection
Adaptive Interventions for Problem Drinkers

The purpose of this study is to understand how certain interventions help people reduce or quit their drinking and how certain interventions may help best at certain points in time in the change process.

Problem drinkers (PDs) represent a majority of the estimated 32 million Americans with alcohol problems that spans a spectrum of severity from individuals who drink excessively and experience of occasional negative consequences to those with moderate Alcohol Dependence (AD) and intact psychosocial functioning. PDs can benefit from relatively brief treatment that could be delivered in mainstream healthcare, but less than 5% receive such care. In addition, PD treatment is only modestly effective, and there is a surprising absence of empirical research to guide PD treatment selection. Adaptive Interventions (AI) are a novel approach to treatment development that may have significant advantages over fixed treatments in improving efficacy and fostering adoption of Evidence Based Practices in mainstream healthcare. If study aims are achieved, a set of empirically-derived decision support tools will be created to guide Alcohol Use Disorders (AUD) care similar to tools that exist for other chronic diseases. In addition, new knowledge will be gained about Mechanisms of Behavior Change of AUD that can guide future AUD treatment research. Finally, important progress will be made in methods that capitalize on the remarkable advances in sensor technologies, advanced mathematics, and engineering to create a new type of tailored, near-real time feedback, adaptive behavior therapies.

Eligibility Criteria:
Primary Inclusion Criteria: Adults who have heavy weekly alcohol consumption (and/or an alcohol use disorder) and are willing to reduce their drinking.

Primary Exclusion Criteria: Adults for whom the level of treatment provided is not appropriate and/or who require more intensive substance use or psychiatric treatment.
Exploratory Study on HER2 Detection Method and Positive Threshold for High-grade Serous Adenocarcinoma of the Ovary

Ovarian cancer is the most lethal gynecological malignancy, and 70% of ovarian cancer patients are diagnosed late at the time of new diagnosis. Even after systematic treatment, 75% of patients still relapse within 3 years and 70% die within 5 years. The survival prognosis of platinum resistant and refractory ovarian cancer populations is currently an urgent issue that needs attention. Antibody drug conjugate (ADC) targeting human epidermal growth factor receptor 2 (HER2) significantly improved the survival prognosis of patients with multiple solid tumors, such as breast cancer, gastric cancer, colorectal cancer, etc. Anti HER2 drugs have been a research hotspot in the treatment of advanced ovarian cancer in recent years. The expression status of HER2 has a decisive impact on the efficacy of ADC drugs targeting HER2. However, there is still a lack of large-scale data on HER2 expression rate in ovarian cancer patients, and there is no clear detection standard to guide clinical practice, which restricts the application of anti-HER2 ADC drugs in ovarian cancer.

To address this critical clinical issue, we initiated this study, which was divided into two parts: ① Retrospective study: Using the existing 144 samples of high-grade serous epithelial ovarian cancer(HGSOC) in our center, we used immunohistochemistry (IHC), DNA in situ hybridization (ISH), and second-generation sequencing (NGS) techniques to detect HER2 status, clarify the relationship between HER2 expression rate and patient survival outcomes, and preliminarily explore the best detection techniques and corresponding positive judgment thresholds for evaluating HER2 status in HGSOC; ② Real world observational study: To verify the predictive value of the positive judgment threshold determined in ① for efficacy in 20 ovarian cancer patients who received HER2 targeted ADC drugs due to platinum resistance/platinum refractory and no other effective treatment options in clinical practice. The aim of this project is to explore for the first time a reliable and feasible method for assessing the expression status of HER2 in patients with epithelial ovarian cancer, in order to provide a basis for subsequent evaluation of targeted HER2 therapy.


Eligibility Criteria:
Inclusion Criteria:

1. Pathological type: high-grade serous adenocarcinoma of the ovary
2. Pathological slices stored within 5 years
3. FIGO stage II or above
4. Complete clinical and follow-up data

Exclusion Criteria:

1. Slice quality control failure
2. Incomplete follow-up data