cyrilzakka/clinical-trials huggingface dataset:
Measuring Fatigue in Triage: A Pilot Study

The purpose of this study is to determine how the length of a triage shift (i.e. 4 vs., 8 vs., 12 hours) affects fatigue levels among triage nurses in the Emergency Department (ED).

This will be a prospective descriptive pilot study. The demographic data forms and the adapted reaction questionnaires will be administered to subjects via pen and paper after obtaining informed consent at the conclusion of the staff meetings. They will be collected by administrative assistants and placed into a secure drop box, located in the study coordinator's office. Only the assigned unique subject ID will be used on all data forms.

During the ED triage data collection phase, administrative assistants will be on-site to give triage nurses the fatigue questionnaire. It will be completed using pen and paper every two hours, with subjects cued to complete the questionnaire by administrative assistants.

After the subject completes the survey, he/she will place it in an envelope and hand it to the administrative assistant who will place it into a secured drop box, located in a study coordinator's office. No PHI or identifying data will be on the completed surveys. Each participant will only use the previously assigned unique subject ID, known only to the study coordinator \& Co-PIs, \& PI. The key to the unique ID will be kept in a locked secure file accessible only by the study coordinator and Co-PI.

Data will be collected over a total of six 24-hour periods. The first 24-hour data collection period will take place on a high volume day (Monday) in which triage nurses will be assigned to 12-hour triage shifts. The second 24-hour data collection period will take place on a low volume day (Sunday) in which triages nurses will again be assigned to 12-hour triage shifts. The third 24-hour data collection period will take place on a high volume day (Monday) in which nurses will be assigned to 8-hour triage shifts. The fourth 24-hour data collection period will take place on a low volume day (Sunday) in which nurses will again be assigned to 8-hour triage shifts. The fifth 24-hour data collection period will take place on a high volume day (Monday) in which nurses will be assigned to 4-hour triage shifts. The sixth 24-hour data collection period will take place on a low volume day (Sunday) in which nurses will again be assigned to 4-hour triage shifts.

Eligibility Criteria:
Inclusion Criteria:

-Eligible nurses include those who:

* are regularly assigned to triage
* have demonstrated competency by passing the ESI Triage class. (Nurses in both emergency departments are required to attend a course in Emergency Severity Index (ESI), as well as demonstrate competency through ESI testing prior to being assigned to work in the triage area. Before taking the course, a nurse is required to have one year of nursing experience.)

Exclusion Criteria:

* None
A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HRS-1301 in Healthy Subjects

This study aims to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HRS-1301 following single and multiple dose administration in healthy subjects. The study consists of two parts (Part 1 and Part 2) with 82 subjects planned to be enrolled. Possible adjustments to sample size, treatment duration and follow-up time will depend upon emerging data.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy male and female subjects must be at least 18 years old and no more than 55 years old on the date of signing the ICF.
2. The female subjects must be non-pregnant or non-childbearing potential.
3. Subjects must understand the study procedures and methods, voluntarily participate in this study and sign the ICF in person.

Exclusion Criteria:

1. Have a gastrointestinal, liver or kidney disease or other condition known to affect drug absorption, distribution, metabolism and excretion or to reduce adherence, as determined by the investigator.
2. Those who had severe trauma or had undergone surgery within 3 months prior to screening, or planned to undergo surgery during the trial.
3. Have a history of repeated drug allergies.
4. People who have used any drug in the 2 weeks prior to screening.
5. Those who received live (attenuated) vaccine within 4 weeks prior to screening or planned to receive it during the trial.
Study to Evaluate the Safety and Efficacy of Sorafenib, in Subject With Refractory Solid Tumors

This study is a single arm, pilot study of Sorafenib in patient with BRAF mutation Refractory solid tumor and specific sensitivity to Sorafenib by Avatar scan that has progressed following standard therapy or that has not responded to standard therapy or for which there is no standard therapy.

To investigate the efficacy and safety of Sorafenib in patient with Refractory solid tumor.


Eligibility Criteria:
Inclusion Criteria:

* Provision of fully informed consent prior to study specific procedures.
* Patients must be \>= 19 years of age
* BRAF mutation, Refractory solid tumor and/or specific sensitivity to Sorafenib by Avatar scan that has progressed following standard therapy or that has not responded to standard therapy or for which there is no standard therapy.
* ECOG Performance status0-2
* Have measurable or evaluated disease based on RECIST 1.1 as determined by investigator.
* Adequate Organ Function Laboratory values

  * Absolute neutrophil count \>= 1.5 x 109/L, Hemoglobin \>= 9g/dL, Platelets\>=100x 109/L Bilirubin \<= 1.5 x upper limit of normal AST/ALT \<= 2.5 X upper limit of normal(5.0 x upper limit of normal, for subject with liver metastases) Creatinine\<= 1.5 X UNL
* Patients of child-bearing potential should be using adequate contraceptive measures should not be breast feeding and must have a negative pregnancy test prior to start of dosing
* Adequate heart function

Exclusion Criteria:

* Patients with second primary cancer, except:adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumor curatively treated with no evidence of disease for \<= 5 years.
* Has known active central nervous system(CNS) metastases
* Has an active infection requiring systemic therapy
* Pregnancy or breast feeding
* Patients with cardiac problem
* Any previous treatment with Sorafenib
'Rehabilitation for Life'

Despite implementing hospital quality programs after hip fracture surgery older adults often experience a decline in the level of physical function, reduced quality of life; and the mortality and readmission rates are high.

Early mobilization is important in order to prevent loss of muscle mass; however to prevent morbidity an early start of strength training is also necessary. Furthermore, the risk of complications, morbidity, and mortality are associated with insufficient management of pain.

The project aims to examine the effect of measuring vital signs and consistent rehabilitation in the primary and secondary sectors in older adults after hip fracture surgery.

Method/ design:

The study is a cluster-randomized stepped wedge study. Participants will be recruited among patients admitted to an orthogeriatric ward who are 65 years of age or older and citizens in one of six municipalities. Participants are also the health professionals in the orthogeriatric ward and the six municipalities.

The six municipalities form six clusters, which are randomized, and every three-month one cluster cross from control to intervention.

The study compares usual practice (control) to an intervention named 'Rehabilitation of Life'. An intervention best described as an empowerment-oriented cross-sectorial program including vital sign measurement and systematic progressive rehabilitation and combined with convenient access for collaboration among professionals.

Primary outcomes: Timed Up and Go (TUG) measured 2 months after the time of operation.

The investigators hypothesize that 'Rehabilitation of Life' for older adults with a hip fracture will result in a significant reduced TUG-score in comparison to a practice not offering 'Rehabilitation of Life'.

And as the study is organised across two sectors, the Cumulated Ambulation Score (CAS) makes a second primary outcome. It is hypothesised that patients in the intervention group will achieve a significantly reduced TUG score compared to usual care.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a hip fracture
* Patients of 65 years of age or older
* Patients admitted to an orthogeriatric ward
* Patient who are citizens in one og three municipalities

Exclusion Criteria:

* Patients discharged for permanent residence in nursing homes
* Patients who cannot participate in a conversation
* Terminal registered patients.
Immuno-humoral Rejection Markers in Pulmonary Transplant

Open multicentric prospective study performed on pulmonary transplanted patients to detect the values of different diagnostic markers for immuno- humoral reaction and their roles in the humoral rejection for those patients.


Eligibility Criteria:
Inclusion Criteria:

* Both genders, more than 18 years of age.
* Patients with or without Cystic fibrosis
* Patients with no previous unilateral or bilateral pulmonary transplant or cardiopulmonary transplant
* Patients with no current other disease can affect, in short term, the process or prognosis of the transplant
* Patients had given his agreement to be enrolled in the study

Exclusion Criteria:

* Patient less than 18 year-old
* Patient had previous organ transplant
* Pregnant and/or lactating women
* Female subject in reproductive age does not use effective contraceptive methode
* Alcoholisms or neuropsychosis, conditions that affect the good comprehension of the study
Allogeneic Mesenchymal Stem Cells for Osteoarthritis

This study is designed to know the safety and efficacy of 2 different doses of mesenchymal stem cells in patients suffering from osteoarthritis of knee joint.


Eligibility Criteria:
Inclusion Criteria:

1. Males or females in the age 20 - 70 years (both inclusive)
2. Radiographic evidence of grade 2 to 3 osteoarthritis based on the Kellgren and Lawrence radiographic entry criteria.
3. History of primary idiopathic osteoarthritis of the knee characterized by pain which requires intake of analgesics.
4. Self-reported difficulty in at least one of the following activities attributed to knee pain: lifting and carrying groceries, walking 400 metres, getting in and out of a chair, or going up and down stairs.
5. Patients who have been on stable medication for the past three months.
6. Patients who have not received intra articular steroids or hyaluronan within the last three months.
7. Female patients of childbearing age must be willing to use accepted methods of contraception during the course of the study
8. Ability to provide written informed consent.

Exclusion Criteria:

1. Prior or ongoing medical conditions (e.g., concomitant illness, psychiatric condition, alcoholism, drug abuse), medical history, physical findings, ECG findings, or laboratory abnormality that, in the investigator's opinion, could adversely affect the safety of the subject, makes it unlikely that the course of treatment or follow-up would be completed, or could impair the assessment of study results.
2. History of surgery, including arthroscopy, or major trauma to the study joint in the previous 12 months
3. Signs of active study joint inflammation including redness, warmth, and/or, if qualifying with osteoarthritis of the knee, a large, bulging effusion of the study knee joint with the loss of normal contour of the joint at the screening visit or at the baseline examination
4. Infections in or around the knee.
5. Patients awaiting a replacement knee or hip joint
6. Patients with other conditions that cause pain
7. Significantly incapacitated or disabled and would be categorized as ACR Functional Class IV (largely or wholly incapacitated), or unable to walk without assistive devices
8. Patients with other known rheumatic or inflammatory disease such as rheumatoid arthritis
9. Other pathologic lesions on x-rays of knee
10. Positive hepatitis B surface antigen, hepatitis C antibody test, Anti human immunodeficiency virus (HIV) antibody test, or VDRL
11. History of Bleeding disorders
12. Known hypersensitivity to Hyaluronan products or animal sera
13. For women of child-bearing potential: positive pregnancy test or lactating
A Study of SC-007 in Subjects With Advanced Cancer

This is a multicenter, open-label, Phase 1 study in participants with colorectal cancer (CRC) or gastric cancer to study the safety and tolerability of SC-007 and consists of Part A (dose regimen finding) in participants with CRC followed by Part A in participants with gastric cancer. Part B (dose expansion) will enroll participants into separate disease specific cohorts of CRC or gastric cancer.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed advanced metastatic or unresectable advanced colorectal cancer (CRC) or gastric cancer that is relapsed, refractory, or progressive after:
* CRC: at least 2 prior systemic regimens in the metastatic setting, and as appropriate in patients whose tumors are microsatellite instability-high (MSI-H), pembrolizumab as well.
* Gastric cancer (including gastric and EGJ cancers): at least 2 prior systemic regimens in adjuvant, advanced, or metastatic setting and, as appropriate, a human epidermal growth factor receptor 2 (HER2) targeted agent.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Adequate hematologic, hepatic, and renal function.

Exclusion Criteria:

* Any significant medical condition that, in the opinion of the investigator or sponsor, may place the participant at undue risk from the study.
* Has electrocardiogram (ECG) abnormalities that make QT interval corrected (QTc) evaluation difficult.
* Prior exposure to a pyrrolobenzodiazepine or indolinobenzodiazepine based drug.
Effects of Repeated Doses of Foliglurax on Drug Metabolizing Enzymes in Healthy Subjects

The purpose of this study is to help determine which types of drugs that may interact with foliglurax

This study is designed to evaluate the PK of caffeine, montelukast and midazolam following multiple doses of foliglurax in healthy subjects. The study is divided into four periods:

* Period 1: investigation of the CYP450 probe substrates (caffeine, montelukast, midazolam) alone followed by a 2-day washout before start of Period 2.
* Period 2: administration of foliglurax for 7 days to reach steady state.
* Period 3: administration of the CYP450 probe substrates in combination with foliglurax followed by a 7-day washout before start of Period 4.
* Period 4: investigation of the effects of foliglurax on the PK of the CYP450 probe substrates following washout of foliglurax.

Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women with a body mass index (BMI) of ≥ 18.5 and ≤ 30 kg/m2 and a minimum body weight of 60 kg for men and 50 kg for women.
* Women of child-bearing potential will have a confirmed non-pregnant and non-lactating status.

Exclusion Criteria:

* The subject has a regular intake of more than 500 mg of caffeine per day or impossibility to stop intake, on holidays for example, without headaches forcing to take caffeine again.

Other in- and exclusion criteria may apply
Standardized Fecal Microbiota Transplantation for Inflammatory Bowel Disease

There are many limitations in the current treatments of Inflammatory bowel disease (IBD). Now the investigators realized that the intestinal microecological is closely associated with the development of IBD. So the standardized fecal microbiota transplantation is considered to be simple but effective emerging therapies for the treatment of IBD. In this project the investigators intend to carry out a single-center, randomized, single-blind clinical intervention study. The investigators will recruit 40 patients with IBD (20 cases of Ulcerative Colitis and 20 cases of Crohn's disease) in China. The patients will be randomly divided into 2 groups, one group will be given treatment of standardized fecal microbiota transplantation, the other will be simply treated with mesalazine, followed up for at least 1 year. The investigators propose to determine the efficiency, durability and safety of Standardized Fecal Microbiota Transplantation for IBD treatment.

In this projects the investigators aim to re-establish a gut balance of intestinal microecological through Standardized Fecal Microbiota Transplantation for IBD (UC and CD). We will establish a standardized isolation, store, and transportion steps of fecal bacteria from donated fresh stool in the laboratory. Then the bacteria will be transplanted to mid-gut by nose-jejunum nutrition tube. Patients in this study will be assigned to receive standardized FMT only once or traditional medicine of mesalazine and would be followed up for at least 1 year. The clinical symptoms, sign, blood tests, abdominal CT, endoscopy and questionnaire will be used to assess the efficiency, durability and safety of Standardized FMT at the start and end of the projects.

Eligibility Criteria:
Inclusion Criteria:

* Severe IBD define as HBI score ≥ 9.
* Moderate IBD define as 7\<HBI \<9
* Montreal classification: Age \> 14 years old, Location L1-3, Behavior B1-3.

Exclusion Criteria:

* Diarrhea activity scores \< 3
* Severely active disease with perianal diseases
* Severely active disease with indication of surgery.
* Diagnosis as IBD first time or first year.
* No history of using 5-ASA, biological (antibody), immunomodulatory therapy, corticosteroid therapy
A Phase 3 Study to Evaluate the Efficacy and Safety of TNX-102 SL in Participants With PTSD

This is a 12-week, multicenter, randomized, double-blind, placebo-controlled, fixed-dose study that will investigate the efficacy and safety of TNX-102 SL 5.6 mg (2 x 2.8 mg tablets) - a sublingual formulation of cyclobenzaprine. Following successful screening and randomization, eligible patients will have a telephonic visit at week 2 and then return regularly to the study clinic for monthly visits for assessments of efficacy and safety.


Eligibility Criteria:
Inclusion Criteria:

* Male and Female subjects between the years of 18-75 with a diagnosis of PTSD (diagnosis can be made at screening)
* Index trauma must have occurred within 9 years of Screening Visit
* Must have occurred when the patient was ≥18 years of age

Exclusion Criteria:

* Use of antidepressant medication within 2 months of Baseline
A Trial to Evaluate the Characteristics of Patients Treated for Advanced Renal Cell Carcinoma With Nexavar ®

Evaluation of the efficacy and safety of Nexavar ® in advanced Renal Cell Carcinoma (RCC) and calculation of related medical costs.


Eligibility Criteria:
Inclusion Criteria:

* Patients with diagnosis of advanced RCC and decision taken by the investigator to prescribe Nexavar®. The patients should have sufficient knowledge of French or Dutch to be able to participate in the Study

Exclusion Criteria:

* Exclusion criteria must be read in conjunction with the Belgian product information
Effectiveness and Safety of Thread Embedding Acupuncture for Drug Resistant Epilepsy

Epilepsy is one of the most common neurological diseases all over the world. Currently, about 70 million people have epilepsy worldwide. In particular, more than 30% of epilepsy patients still have seizures even though they are treated with appropriate anti-epileptic drugs (AEDs). This number has remained unchanged even after more than 20 years with many new anti-epileptic drugs being introduced. According to International League Against Epilepsy (ILAE), drug-resistant epilepsy is defined when a patient does not achieve seizure-free the seizure with two optimal antiepileptic drugs. This clinical trial is designed to evaluate the effectiveness and safety of thread-embedding acupuncture (TEA) as palliative treatment of drug resistant epilepsy.

The objectives of this clinical trial are twofold: the effectiveness of TEA is assessed by comparing the changes in the seizure control and quality of life at 5 months between 2 groups: the TEA + baseline AEDs group and the sham-TEA (STEA) + baseline AEDs group. Adverse events (AEs) that occur during the study will be investigated to evaluate the safety of TEA.

This study is investigated by the following hypotheses:

* TEA can increase the probability of becoming seizure free.
* TEA can reduce the frequency and duration of seizures.
* TEA can improve quality of life.
* TEA is associated with adverse effects.

This clinical trial will be performed as a 2-arm parallel design, randomized, controlled, assessor-blinded, clinical trial.

Eligibility Criteria:
Inclusion Criteria:

* People with drug resistant epilepsy
* Volunteers who agree to participate and sign the Informed Consent Form, following a detailed explanation of clinical trials

Exclusion Criteria:

* Under epilepsy surgery
* Inappropriate condition for thread-embedding acupuncture due to skin disease (the skin of the acupuncture point is swollen, hot, and red) or hemostatic disorder (PT INR (international normalized ratio )\> 2.0 or taking anticoagulant)
* Pregnant women or other inappropriate condition for thread-embedding acupuncture
* Other diseases that could affect or interfere with therapeutic outcomes, including body exhaustion, severe gastrointestinal disease, cardiovascular disease, hypertension, diabetes, renal disease, liver disease or thyroid disorder
* TEA within 6 months previous
* Psychiatric disorder currently undergoing treatment such as depression or schizophrenia
* Heavy drinking (more than 3 cups per day)
Antithrombotic Drug Use in Patients With Ischemic Stroke and Microbleeds

To observe the effect of different antithrombotic drugs on the prognosis of ischemic stroke patients with cerebral microbleeds. And further combined with proteomic methods to explore serological markers that can be used to accurately predict the prognosis of such patients.

Cerebral microbleeds (CMBs) are caused by microvascular lesions in the brain, which is a subclinical deposition of hemosiderin after the damage of microvascular. Antithrombotic drug are widely used in the secondary prevention of patients with ischemic stroke. Studies have shown that antithrombotic drug can increase the incidence of intracranial hemorrhage in ischemic stroke patients with cerebral microbleeds. For such patients, how to carry out effective and safe antithrombotic therapy is still unclear.

We will study from two aspects: 1) We designed a cohort registration study to observe the prognosis and progress of CMBs in ischemic stroke patients one year after using various antithrombotic drugs. 2) Data independent acquisition quantitative proteomics (DIA quantitative proteomics) will be used to screen serum protein markers that may affect the prognosis of ischemic stroke patients with CMBs.

Eligibility Criteria:
Inclusion Criteria:

1. Patients diagnosed clinically as ischemic stroke;
2. Age ≥ 40 years;
3. Onset time ≤ 3 months;
4. Informed consent was signed.

Exclusion Criteria:

1. Patients with symptomatic intracranial hemorrhage;
2. bleeding lesion \> 10 mm was found on SWI;
3. Vascular malformations, tumors, abscesses or other major non ischemic brain diseases were present;
4. There are contraindications for antithrombotic drugs use;
5. Serious systemic diseases;
6. Refusal to sign informed consent or poor compliance.