cyrilzakka/clinical-trials huggingface dataset:
Surveillance of Humira Injection in Korean Patients

Patients who take Humira as prescribed by physicians as per Korean label will be enrolled and observed in normal medical practice setting for not less than 3 months following first dose of Humira. Information on demographics, diagnosis and medical history, results of tuberculosis skin test, results of chest X-ray, Humira treatment information, concomitant medication, physician's global assessment for effectiveness, disease activity assessment for rheumatoid arthritis, disease activity assessment for Crohn's Disease, disease activity assessment for Psoriasis and adverse events will be recorded on case report forms.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (19 years and above) with one of the following indications:

  * Moderately to severely active rheumatoid arthritis or
  * active and progressive psoriatic arthritis when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate or
  * severe active ankylosing spondylitis who have had an inadequate response to conventional therapy or
  * severely active Crohn's disease who have had no response, intolerance or contraindication to corticosteroid therapy or immunosuppressants or
  * moderately to severely active psoriasis patients who have had no response, have intolerance or have contraindication to systemic therapies including cyclosporine, methotrexate or photochemotherapy (PUVA).
* Patients who give verbal or written authorization to use their personal and health data.

Exclusion Criteria:

- Patients with known hypersensitivity to adalimumab or any of its excipients.
An Exploratory Clinical Study of Apatinib for the 2nd Treatment of Esophageal Cancer or Esophageal and Gastric

The purpose of this Phase II, Open-label, single arm, exploratory study is to evaluate the efficacy and the safety of Apatinib（500mg/d）for the second - line treatment of esophageal cancer or esophageal and gastric

This study is a prospective,single-center,single arm,Ⅱ exploratory study.To explore the clinical study of the efficacy and safety of the treatment of vegfr-2 high expression by apatinib mesilate.The main research object for first-line treatment failure Ⅲ/Ⅳ integration of a period of esophageal or gastric esophagus cancer patients.The main purpose of the study was to evaluate apatinib for the median PFS of the esophageal and esophageal gastric junction carcinoma of the esophagus with high expression of VEGFR-2. The objective of secondary research is to evaluate the safety of apatinib for second-line treatment of esophageal and esophageal gastric junction cancer Objective Response Rate (CR + PR) and median OS and explore the relationship between VEGFR-2 high expression and apatinib efficacy and related prognostic factors. Thirty patients were enrolled in the study group. The group was expected to be enrolled in the group for 24 months, followed by 6 months of follow-up and 6 months of data statistics. The drug regimen was a single drug apatinib 500mg qd Po.Please refer to the CRF table for details.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 and ≤ 75 years of age
* Have failed for 1 lines of chemotherapy
* ECOG performance scale 0 - 2.
* Adequate hepatic, renal, heart, and hematologic functions (hemoglobin ≥ 90g/L, platelets ≥ 80×10\^9/L, neutrophils ≥ 1.5×10\^9/L, total bilirubin within 1.25×the upper limit of normal(ULN), and serum transaminase≤2.5×the ULN (If liver metastases, serum transaminase≤5×the ULN), serum creatine ≤ 1.5 x ULN, creatinine clearance rate ≥ 50ml/min.
* Life expectancy of more than 12 months

Exclusion Criteria:

* Existing therapy related toxicity of prior chemotherapy and/or radiation therapy
* Intercurrence with one of the following: hypertension, coronary artery disease, arrhythmia and heart failure
* Any factors that influence the usage of oral administration
* The center of the tumor invaded local large blood vessels
* Within 4 weeks before the first use of drugs, occurs pulmonary hemorrhage (≥ CTCAE class 2) or other parts' hemorrhage (≥ CTCAE class 3).
* Within 6 months before the first treatment occurs artery / venous thromboembolic events, such as cerebral vascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism, etc.
* Less than 4 weeks from the last clinical trial
Comparative Effects of Jandas's Approach With and Without Post Isometric Relaxation Technique

Posterior lower crossed syndrome is a perplexing puzzle of muscular imbalance, manifests as an intricate interplay between weakened glutes and tight flexors. The aim of the study will be to determine the effects of Jandas's approach with and without post-isometric relaxation technique on pain, muscle flexibility, and functional disability in patients with the posterior lower crossed syndrome.

A Randomized Controlled Trial will be conducted at physical therapy department of Rabia Welfare Hospital Lahore, FMH Physiotherapy Clinic Lahore and Shafaeen Physiotherapy Clinic Lahore through convenient sampling technique on 30 patients which will be allocated using simple random sampling through sealed opaque enveloped into Group A and Group B. Group A will be treated with janda's approach and Group B will be treated with combination of post isometric relaxation technique for Illiopsoas and janda's approach at the frequency of 3 sets with 10 repetitions and twice a week. Outcome measures will be conducted through pain,muscle flexibility, pelvic tilt and disability questionnaire after 4 weeks. Data will be analysed using SPSS software version 25.After assessing normality of data by Shapiro-wilk test, it will be decided either parametric or nonparametric test will be used within a group or between two groups.

Eligibility Criteria:
Inclusion Criteria:

* Age:20-60 years
* Gender: Both males and females
* NPRS (Numerical Pain Rating Scale): \< 7
* Positive Finger to Floor Test : \> 48cm in males, \>50cm for females
* Positive Modified Thomas Test: greater than zero
* Patients with anterior pelvic tilt

Exclusion Criteria:

* Preexisting spinal pathology
* Congenital abnormality
* Neurological deficits,
* Recent spinal or lower-limb trauma or surgery
* Spasm of the trunk or lower-limb muscles
* Lower-limb radiculopathy
* Pregnancy
Explore Biomarkers of Motor Neuron Disease/Frontal Dementia Spectrum Disease in China

1. To investigate the biomarkers of MND/FTD spectrum disease
2. To explore the possible pathogenesis of MND/FTD

Motor neuron disease (MND) is a group of disease characterized by motor neuron disorders and neurodegeneration. MND and frontotemporal dementia (FTD) were believed to comprise a neurodegenerative disease spectrum. The prognosis of the disease spectrum varies according to the type of disease, and the diagnosis of patients is often delayed due to insufficient diagnostic biomarkers. In recent years, the academic community has made significant progress in the study of biomarkers of the disease, but there is still a lack of specific biomarkers with strong diagnostic value. Besides, the low prevalence makes it difficult to carry out studies with large samples. The aim of this study was to explore diagnostic biomarkers of the disease spectrum by collecting variable samples from a large group of patients. The findings will both offer a better understanding of MND/FTD spectrum disease and also support the development of a model to study other rare diseases.

Eligibility Criteria:
Patients:

Inclusion Criteria:

1. Patients aged 18-80 years who visit Peking University Third Hospital, Beijing, China from December 2020.

   Patients who diagnosis MND/FTD spectrum disease (including ALS, FAS, FLS, PLS, PBP, PMA, FTD, MND-FTD) by an experienced neurologist strictly according to a list of diagnosis criteria and clinical guidelines
2. Informed consent signed Exclusion Criteria

   * Patients who receive alternative diagnoses during the follow-up.
   * Patients who refuse to sign informed consent.

Control group:

Control group consists of individuals matched for gender and age with the patients who are mainly the caregivers of the patients, including but not limited to the patients' spouses and their long-term nurses.

Exclusion criteria:

1. Suffering from neurological disease, including but not limited to motor neuron disease/frontotemporal dementia spectrum disease, dementia, Alzheimer's disease, Parkinson's disease, multiple sclerosis, neuromyelitis and so on.
2. Individuals who refuse to sign informed consent.
Chronic Fatigue Etiology in Intensive Care Unit Survivors: the Role of Neuromuscular Function

Chronic fatigue is the most common and debilitating symptom in intensive care unit (ICU) survivors. Indeed, it has been widely reported that patients who stayed in ICU for prolonged periods report a feeling of tiredness for months to years after ICU discharge. This chronic fatigue affects their quality of life by decreasing their capacity to perform simple tasks of daily life.

The aim of the present project is to determine whether deteriorated neuromuscular function (i.e. increased fatigability) is involved in this feeling of chronic fatigue. Because the causes of this feeling are multi-dimensional, a large battery of tests will allow us to better understand the origin of chronic fatigue. A better knowledge of chronic fatigue etiology will allow to optimize rehabilitation treatments to decrease the apparition/persistence of chronic fatigue and in fine improve life quality.


Eligibility Criteria:
Inclusion Criteria:

* Have been ventilated for at least 72 hours in the intensive care unit
* IGS2 score (severity in resuscitation) \> 15
* FACIT-F (Functional Assessment of Chronic Illness Therapy-Fatigue) score ≥ 36 or a score ≤ 32
* intensive care unit discharge in ≥ 6 months and ≤ 5 years preceding the study
* Approval received from a physician
* Command of the French language

Exclusion Criteria:

* Taking neuroactive substances that can alter corticospinal excitability
* Contraindication to the application of a magnetic field
* Contraindication to the practice of Magnetic Resonance Imaging
* Participant is pregnant
* Patients with psychiatric disorders
* Paraplegic and hemiplegic patients
* Addictive disorders
The Effect of Glutamine on Systemic Inflammation During Human Experimental Endotoxemia

Glutamine levels decrease during severe sepsis; this may be associated with increased mortality. The investigators tested the effects of glutamine supplementation on systemic inflammation in a human sepsis model.

The investigators found that glutamine levels drops significantly during experimentally induced systemic inflammation. However, glutamine did not affect the degree of inflammation.

Glutamine levels have been shown to decrease substantially with severe sepsis and this has been connected with increased mortality. Therefore, in the present study, we infused either saline or Alanine-glutamine during an endotoxin challenge and measured parameters related to an immune response, i.e. plasma cytokines and Heat Shock Protein (HSP)-70.

Materials and Methods This was a double blind, randomised, placebo-controlled crossover trial in eight healthy young men. The study was performed in random order on two separate days, with a four-week washout period between days. Subjects received an infusion of Alanine-glutamine ( Dipeptiven) at a rate of 0.025 g / (kg BW \* h) for 10 hrs or saline. After two hours of infusion subjects received an intravenous bolus of E. coli endotoxin (0.3 ng/kg). Blood samples were collected hourly for the following eight hours. HSP-70 protein content in isolated Blood Mononuclear Cells (BMNCs) was measured by western blotting.

Results and Discussion Plasma glutamine was significantly increased during infusion with alanine-glutamine infusion. En-dotoxin caused a reduction in plasma-glutamine during saline infusion as well as during Alanine-glutamine infusion. A significant effect of endotoxin was found on leukocyte subpopulations, tumor necrosis factor-a, interleukin-6, the expression of HSP-70 in BMNCs, temperature, and heart rate. However, no differences were detected between treatments with regard to the effect of endotoxin on any of these parameters.

Conclusion Endotoxemia reduces plasma glutamine independently of parenteral infusion of alanine-glutamine. Glutamine does not alter the response of leukocytes, leukocyte subpopulations, IL-6, or TNF-α, or the expression of HSP-70 in BMNCs to endotoxemia.

Eligibility Criteria:
Inclusion Criteria:

* Healthy young males

Exclusion Criteria:

* Any kind of acute or chronic diseases
Repurposing Atovaquone for the Treatment of Platinum-Resistant Ovarian Cancer

This phase II trial test tests how well repurposing atovaquone works in treating patients with platinum-resistant ovarian cancer. Atovaquone is used for the treatment or prevention of certain infections. Atovaquone is in a class of medications called antiprotozoal agents. It works by stopping the growth of certain types of protozoa that can cause pneumonia. Giving atovaquone may be effective in treating platinum-resistant ovarian cancer and result in improved outcomes compared to standard chemotherapy regimens.

PRIMARY OBJECTIVE:

I. To determine progression free survival of twenty-eight patients with platinum-resistant ovarian cancer treated with atovaquone.

SECONDARY OBJECTIVES:

I. To determine clinical benefit rate (complete response, partial response or stable disease) at six months.

II. To determine overall survival. III. To quantitate the on-target STAT3 inhibitory effect of atovaquone on STAT3-dependent gene transcription.

IV. To quantitate changes of the tumor immune infiltrate by inhibition of STAT3 with atovaquone.

OUTLINE:

Patients receive atovaquone orally (PO) on study. Patients also undergo computed tomography (CT) and biopsy or paracentesis throughout the study.

After completion of study treatment, patients are followed up for 30 days and then every 6 month thereafter.

Eligibility Criteria:
Inclusion Criteria:

* Patients with platinum-resistant, high-grade serous ovarian cancer, defined as disease progression within six months of completion of their last platinum-based chemotherapy
* Patients must maintain Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* There will be no limitations on number of prior lines of therapy
* Trial is open to non-English speaking patients
* Trial is open to patients referred from community practice

Exclusion Criteria:

* Patients who are \< 18 years old
* Patients who are pregnant or breastfeeding (due to cancer of their reproductive organs, patients enrolled in the trial are unable to conceive)
* Patients who are incarcerated
* Patients who are unable to provide consent / lack decision-making capacity
Neurocognitive Function After Carotid Thrombendarterectomy

Previous studies did not reach a consensus on the influence of the type of anesthesiologic procedure and monitoring, during carotid thrombendarterectomy, on perioperative complications and cognitive outcomes. The aim of this study is the optimization of brain perfusion during the vascular carotid clamp using multimodal monitoring. We assume that standardized monitoring techniques and a better selection of cognitive tests will allow a more accurate assessment of subclinical cognitive deficits.

ABSTRACT:

AIM OF THE STUDY: Effect of perioperative multimodal monitoring with transcranial doppler (TCD), near-infrared spectroscopy (NIRS), and Electroencephalography (EEG) in patients for carotid thrombendarterectomy (CEA) on perioperative complications and cognitive functions.

PATIENTS AND METHODS: The prospective study will analyze 80 consecutive patients with an asymptomatic and symptomatic (transitory ischemic attack, TIA, in anamnesis) stenosis of the internal carotid artery in which CEA is indicated in general anesthesia. Cognitive tests will be analyzed for all patients preoperatively, first and eighth day postoperatively, and after 8 weeks. Breath-holding index (BHI) will be measured preoperatively and postoperatively. The first group of patients (n = 40) will have expanded intraoperative monitoring involving TCD, NIRS, and EEG, and the control group (n = 40) will have only standard anesthetic monitoring.

EXPECTED CONTRIBUTION OF THE STUDY: Previous studies did not agree on the influence of the type of anesthesiologic procedure and monitoring of perioperative complications and cognitive outcomes. We assume that standardized monitoring techniques and a better selection of cognitive tests will allow a more accurate assessment of the effect.

Eligibility Criteria:
Inclusion Criteria:

* patients with The North American Symptomatic Carotid Endarterectomy Trial (NASCET) stenosis of more than 70%
* symptomatic stenosis
* asymptomatic stenosis
* elective surgery patients
* signed informed consent
* initial MoCa test equal and more than 22

Exclusion Criteria:

* who refuse to participate
* previous stroke in anamnesis
* patient without bone window for BHI measurements
* comorbidities with aphasia and plegia, and the impossibility to solve cognitive tests
Effects of Butyrate on Affective Processes

The effects of butyrate on psychobiological processes are examined in a sample of healthy volunteers.

The study is an interventional triple-blind, placebo-controlled, parallel group design with 2 arms (placebo, butyrate). Healthy male participants adhere to a low-fiber diet for the duration of the study (11 days). At the baseline study visit, measurements are taken in the lab, including biological samples and psychophysiological measurements. Participants then consume placebo or butyrate for 1 week and revisit the lab on day 11 for a second measurement of the outcomes of interest. Specifically, we investigate the effect of colonic butyrate administration on affective processing, including stress sensitivity and fear-related processes (e.g. extinction learning). Volunteers also respond to questionnaires in relation to mood and GI symptoms, and provide biological samples (saliva, blood, and faecal samples) for analysis of cortisol levels, circulating short chain fatty acids and serum BDNF, and faecal SCFA, respectively.

Eligibility Criteria:
Inclusion Criteria:

* Male participants
* Age range 20-40 years
* BMI range 18.5-25
* Dutch or English as native-language

Exclusion Criteria:

* previous or current neurological, psychiatric, gastrointestinal or endocrine disorders, or other relevant medical history
* current or recent regular medication use
* previous or current substance/alcohol dependence or abuse (\> 2 units per day/14 units per week)
* one or more diagnoses based on the mini-international neuropsychiatric interview
* smoking
* night-shift work
* adherence to vegan or vegetarian diets
* use of pre- or probiotics within one month preceding the study
* use of antibiotics within 3 months preceding the study
* previous experience with one of the tasks used in the study
Effect of Electroacupuncture at Different Acupoints on Bladder Function After Spinal Cord Injury

Neurogenic bladder after spinal cord injury can be divided into detrusor hyperreflexia and detrusor non reflexia. Acupuncture is recognized as a safe and effective treatment. The most commonly used acupoints are Guanyuan, Zhongji and Sanyinjiao. The purpose of this study is to clarify the therapeutic effects of different acupoints on different types of bladder. Main process: routine urodynamic examination was performed first, and then electroacupuncture was given to Guanyuan, Zhongji and Sanyinjiao points respectively, and urodynamic examination was performed again to observe the effect of Electroacupuncture on urodynamic parameters in real time.


Eligibility Criteria:
Inclusion Criteria:

* patients diagnosed with traumatic suprasacral SCI.
* the period of the spinal shock has passed.
* patients with voiding dysfunction after SCI.
* patients had stable condition, and suitable for treatment.
* agreed to engage in our study and sign the informed consent.

Exclusion Criteria:

* Patients with severe primary diseases such as heart, liver, kidney, hematopoietic system, endocrine system and psychosis.
* dysuria caused by non spinal cord injury, such as prostatic hypertrophy, urethral obstruction, operation.
* Patients who have already taken cystostomy and sacral electrode implantation.
* Patients with urinary tract infection.
* Autonomic hyperreflexes were obvious.
* Unable to cooperate with the healer.
Metabolomics During ElectroConvulsivoTherapy

Investigators will measure the variation of blood Metabolome through 1H NMR at several time points during the course of electroconvulsivetherapy in patients with a major depressive episode. Patients with a major depressive disorder or a bipolar disorder and a current major depressive episode will be included in this study. Investigators hypothesized that Metabolome could be a source to predict response during ECT and to help understanding underlying biological mechanisms.

Biological signatures of blood metabolome will be measure before and after the first session of electroconvulsivetherapy, and during the course, before the 6th, 12th and the last sessions. Proton Nuclear Magnetic Resonance spectroscopy will be used to measure metabolites in blood sample. In parallel, at each time point, depression severity (MADRS and BDI), Perceived severity (CGI), global functioning (EGF), convulsive characteristics and cognitive tolerance (MOCA) will be measure, at each time point.

The aim of this study is to determine whether 1HNMR could help to understanding metabolic ways and predict response to ECT in patients with a current Major Depressive Episode (MDE) in Major Depressive Disorder (MDD) and in Bipolar Disorder (BD).

To date, scientific community knows that ECT is a safety and efficacy treatment in MDE particularly resistant or severe, but scientific community knows little about its mechanism of action.

The investigators hypothesize that 1HNMR could help to go further.

Eligibility Criteria:
Inclusion Criteria:

* Major depressive episode according to DSM-5 criteria
* Diagnosis of major depressive disorder or bipolar disorder
* MADRS score \>22
* having given written, free and informed consent
* without protective measures
* resistance criterion defined as failure of 2 antidepressants at an effective dose for a minimum of 6 weeks
* current major depressive episode according to DSM-5 criteria with indication of treatment by ECT cure

Exclusion Criteria - Cannot be included in the study, people:

* whose consent is not admissible or who refuse to participate in the study
* deprived of liberty by judicial or administrative decision
* For which there is a particular risk contraindicating the cure of ECT
* Suffering from schizophrenia spectrum disorders or persistent delusional disorder as described by DSM-5 Criterion D for Major Depressive Disorder
* suffering from neurological disorders (such as patients suffering from multiple sclerosis, epilepsy, encephalitis, etc.) and/or neurodegenerative disorders (such as Parkinson's disease, Alzheimer's disease or related diseases, etc.) as described by criterion C of the major depressive disorder listed in the DSM-5
* suffering from an acute or chronic systemic inflammatory disease requiring specific treatment with immunomodulators or suppressors. As well as any recurrent inflammatory disease requiring specific management, and which may lead to a differential diagnosis of the characterized depressive episode as described by criterion C listed in the DSM-5