cyrilzakka/clinical-trials huggingface dataset:
Self Transcranial Direct Current Stimulation for Pain in Older Adults With Knee Osteoarthritis

The purpose of this study is to determine the feasibility and preliminary efficacy of two weeks of self Transcranial Direct Current Stimulation (tDCS) for pain in older patients with knee osteoarthritis (OA).


Eligibility Criteria:
Inclusion Criteria:

* have self-reported unilateral or bilateral knee OA pain, according to American College of Rheumatology criteria
* have had knee OA pain in the past 3 months with an average of at least 3 on a 10 cm Visual Analog Scale (VAS) for pain
* can speak and read English
* have a device with internet access that can be used for secure video conferencing for real-time remote supervision
* have access to a distraction-free, well lit, clean environment with a safe area to store the device and device kit
* have no plan to change medication regimens for pain throughout the trial
* are able to travel to the coordinating center
* are willing and able to provide written informed consent prior to enrollment.

Exclusion Criteria:

* previous prosthetic knee replacement or non-arthroscopic surgery to the affected knee
* history of brain surgery, tumor, seizure, stroke, or intracranial metal implantation
* systemic rheumatic disorders, including rheumatoid arthritis, systemic lupus erythematosus, and fibromyalgia
* uncontrolled hypertension (i.e., systolic blood pressure/ diastolic blood pressure ≥ 150/95 mm Hg)
* heart failure
* history of acute myocardial infarction
* peripheral neuropathy
* alcohol/substance abuse
* cognitive impairment (i.e., Mini-Mental Status Exam score ≤ 23)
* pregnancy or lactation
* hospitalization within the preceding year for psychiatric illness
Study of SCB01A in Patient With Head and Neck Cancer

To evaluate the safety and efficacy of SCB01A in head and neck cancer.

The study is designed to evaluate the safety and efficacy of SCB01A in patients with recurrent or metastatic squamous cell carcinoma in head and neck.

Eligibility Criteria:
Inclusion Criteria:

1. Confirmed squamous cell carcinoma of head and neck
2. Patients with nonresectable, unfeasible radiotherapy, recurrent or metastatic carcinoma, after previous treatment with platinum agent.
3. At least one measurable tumor lesion according to RECIST
4. Suitable Eastern Cooperative Oncology Group (ECOG) performance status
5. All eligible patients of childbearing potential have to use effective contraception
6. Signed informed consent before enrolment

Exclusion Criteria:

1. Receiving Chemotherapy, radiation therapy, major surgery or investigational agents
2. Severe pulmonary obstructive or restrictive disease
3. Uncontrolled inflammatory disease
4. Clinically significant cardiac disease
5. Results of laboratory tests
6. Pregnancy or nursing status
7. Known hypersensitivity to any component of SCB01A
8. History of exposure to SCB01A or its analogues
9. History of malignancy other than head and neck cancer
10. History of active or significant neurological disorder or psychiatric disorder
11. Any other reason the investigator deems the patient to be unsuitable for the study
Evaluation of Equivalent Minimum Alveolar Concentration (eMAC) During Propofol/Remifentanil Anesthesia

The aim of this study is to verify the accuracy of eMAC compared to Bispectral Index (BIS) for depth and nociceptive stimulation monitoring of anesthesia during general anesthesia.

eMAC is a new index based on response surface model for evaluating anesthesia state and anti-nociceptive stimulation levels. To valid it's clinical accuracy, a protocol was designed.

Patients will be allocated to receive a specific effect-site concentration of remifentanil and propofol during tonic electrical stimulation (5s, 50mA) and intubation. The concentration combinations include the electrical stimulation combination (effector chamber concentration random: remifentanil 0-3 ng/ml, propofol 3-5 ug/ml) and the intubation combination (effector chamber concentration random: remifentanil 3-5 ng/ml, propofol 3-5 ug/ml). All combinations were decided before operation. Every combination had a 5 min equilibration period, and the vital signs (Heart Rate, Blood pressure, any body movement) and BIS, eMAC will be recorded before and after the electrical stimulation and intubation. After this period, patients will be randomly allocated to receive an intravenous anesthesia or intravenous combined anesthesia, and regular anesthesia is executed. This study only records vital signs and BIS, eMAC during maintenance period of perioperative.

Eligibility Criteria:
Inclusion Criteria:

1. Patients undergoing elective surgery under general anesthesia;
2. Patients with ASA rating I\~III;
3. The age of the patient is more than 18 years old;
4. The informed consent has been signed;

Exclusion Criteria:

1. Patients who are participating in other trials;
2. Patients with cognitive impairment, mental illness or taking psychotropic drugs within three months;
3. Patients with a history of stroke;
4. Patients with a history of alcoholism (long-term drinking more than 5 years, daily white wine consumption ≥ 50ml);
5. Pregnant women;
6. Patients with BMI\>30;
7. Patients and family members who are unwilling to participate after understanding the research content;
8. According to the evaluation of the researcher, the actual condition is not suitable for the patients participating in this trial.
Oxycodone in Serum After Postoperative Oral Oxycodone in Caesarean Sections Under Spinal Anesthesia

All patients undergoing an elective caesarean section under spinal anesthesia will, according to the hospital routines, receive 10 mg oxycodone slow-release tablet when arriving at our postoperative care unit (PACU). Blood samples will be taken at 0 hour, 1 hour, 2 and 6 hours after administration in order to investigate bioavailability.

After written informed consent, blood samples will be taken before administration, after 1 hour, 2 hours and 6 hours. Need of rescue analgesia (morphine iv) and level of pain, as well as side effects will be registered

Eligibility Criteria:
Inclusion Criteria: Healthy women \> 18 years old, with one healthy fetus scheduled for a elective caesarean section in spinal anesthesia, read and signed informed consent

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Exclusion Criteria:

* Known intolerability to oxycodone. Previous use of opioids. Hight \< 150 cm, preconceptual BMI \> 35. ASA \> 2.
A Safety and Efficacy Study for Infliximab (Remicade) in Patients With Active Ulcerative Colitis

The purpose of this study is to evaluate the effectiveness and safety of infliximab (Remicade) in patients with Ulcerative Colitis.

This is a study designed to investigate the safety and effectiveness of a medication called infliximab (the active drug in (REMICADE®) in adult patients with active ulcerative colitis. The purpose of this study is to see if the symptoms of ulcerative colitis are lessened with this medication, infliximab, and what dose is needed to do that safely. Patients will receive infusions of either 5mg/kg, 10 mg/kg or placebo at weeks 0, 2, 6, and then once every 8 weeks thereafter through week 46 for up to 3 years.

Safety evaluations will be performed at specified intervals throughout the study and will consist of laboratory tests, vital signs (such as blood pressure), physical examinations and the occurrence and severity of adverse events as well as other study specific procedures. Patients will receive infusions of either 5mg/kg, 10 mg/kg or placebo at weeks 0, 2, 6, and then once every 8 weeks thereafter through week 46 for up to 3 years.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have had ulcerative colitis of at least 3 months' duration at screening
* Patients who have ulcerative colitis confirmed by the biopsy taken at screening
* Patients must have active colitis confirmed during the screening sigmoidoscopy
* Patients must have active disease.

Exclusion Criteria:

* Patients must not be likely to require surgical removal of all or part of the colon within 12 weeks of beginning the study
* Patients must not require, or required within the 2 months prior to beginning the study, surgery for active gastrointestinal bleeding, peritonitis, intestinal obstruction, or intra-abdominal or pancreatic abscess requiring surgical drainage
Role of HbA1c in Predicting Adverse Pregnancy Outcomes

This study aims to determine the reference value of HbA1c that can be used to predict adverse pregnancy outcomes. These adverse outcomes include LGA fetus, shoulder dystocia, caesarean section, pre-term birth, pre-eclampsia and fetal neonatal hypoglycaemia.

This study involves the data in our centre concerning women with gestational diabetes mellitus. The diagnosis of gestational diabetes mellitus is based on NICE guideline whereby the fasting glucose is 5.6 mol/l or more and 2 hours post glucose load 7.8 mol/l or more. The results of HbA1c and fructosamine taken during the antenatal care are documented. Outcomes of the pregnancy are documented such as antenatal complications, mode of delivery, gestational age at delivery, intrapartum and postpartum complications and neonatal complications. The results of this study is hoped to provide information on the optimum targeted levels of HbA1c and fructosamine for patients with gestational diabetes mellitus. This is the gap in knowledge in managing this cohort of patients.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant woman with singleton pregnancy
* Confirmed diagnosis of GDM based on Malaysia CPG (≥5.1/7.8)
* HbA1c level taken at least once at any time during the pregnancy
* Delivery after 28 weeks gestation

Exclusion Criteria:

* Major fetal anomaly
* Haemoglobin level of ≤9 g/dL (moderate or severe anaemia in pregnancy)
* Women with autoimmune diseases
* Overt diabetes or pre-existing diabetes
Decision Support System on Emergency Triage

The objective of this study is to design a computer-based Decision Support System (DSS) using the ESI (Emergency Severity Index) and ATS (Australasian Triage Scale) algorithms, integrate it into the Hospital Information Management System (HIMS), evaluate the effect of the triage management in the emergency department and ensure the continuity of the system.

Background: Triage in the emergency department overstrains employees due to patient density, diversity, and time pressure.

Aim: The objective of this study is to design a computer-based Decision Support System (DSS) using the ESI (Emergency Severity Index) and ATS (Australasian Triage Scale) algorithms, integrate it into the Hospital Information Management System (HIMS), evaluate the effect of the triage management in the emergency department and ensure the continuity of the system.

Study design: This is a quasi-experimental study with a single-group pre-test and post-test design. The study consisted of three stages.

Methods: In the first stage, a SQL (Structured Query Language) Script was developed to evaluate the accuracy and duration of pre-and post-DSS triage decisions. In the second stage (pre-test), the accuracy and duration of pre-DSS triage decisions were evaluated. In the second stage, a DSS was prepared with rule-based decision trees method using the ESI and ATS algorithms and was integrated into the HIMS. In the third and last stage (post-test), the effect of the developed Emergency Triage Decision Support System (ETDSS) on triage management was evaluated against the accuracy and duration of triage decisions.

Eligibility Criteria:
Inclusion Criteria:

Data of adult patients who applied to the adult emergency department and whose triage record was opened by a triage nurse.

Patient data with no probable or definitive diagnosis of COVID-19.

Exclusion Criteria:

Data of pediatric trauma patients (under 18 years of age) Patient data for which the triage record was opened by non-nursing healthcare professionals Patient data recorded in triage by nurses who did not receive ATKDS, Emergency nurse triage, ESI, ATS training Data of patients who applied with a probable/definite diagnosis of COVID-19 and underwent PCR testing Patient data in the date range when extraordinary changes were made in the adult emergency department patient triage area and evaluation process due to the COVID 19 pandemic and the developed system could not be used (must use the SB COVID Algorithm)
NPI-0052 and Vorinostat in Patients With Non-small Cell Lung Cancer, Pancreatic Cancer, Melanoma or Lymphoma

This is a clinical trial examining the safety, pharmacokinetics, pharmacodynamics and efficacy of IV NPI-0052 (a proteasome inhibitor) in combination with oral vorinostat (Zolinza; a HDAC inhibitor) in patients with non-small cell lung cancer, pancreatic cancer, melanoma or lymphoma. Proteasome inhibitors block the breakdown of proteins by cells and HDAC inhibitors block modification of proteins regulating gene expression in cells. Both of these actions preferentially affect cancer cells, and the combination of the two has been seen to have a greater effect in laboratory studies.


Eligibility Criteria:
Inclusion Criteria:

1. Karnofsky Performance Status (KPS) at 70% or more.
2. Non-small cell lung cancer, pancreatic adenocarcinoma, melanoma or lymphoma for which a standard, approved therapy is not available. Patients must have lesions that are evaluable by RECIST criteria.
3. All Adverse Events of any prior chemotherapy, surgery, or radiotherapy, must have resolved to CTCAE (v. 3.0) Grade 1 or less(except for hemoglobin).
4. Adequate bone marrow, renal, liver function.
5. Signed informed consent.

Exclusion Criteria:

1. Recent administration of chemotherapy, biological, immunotherapy or investigational agent, major surgery, or radiotherapy.
2. Intrathecal therapy.
3. Known brain metastases.
4. Significant cardiac disease.
5. Prior treatment with vorinostat or NPI-0052, or other HDACi (including valproic acid) or proteasome inhibitors.
6. Known allergy to any component of vorinostat. Prior hypersensitivity reaction of CTCAE Grade \> 3 to therapy containing propylene glycol or ethanol.
7. Pregnant or breast-feeding women.
8. Concurrent, active secondary malignancy for which the patient is receiving therapy.
9. Significant active infection.
Study Evaluating Bazedoxifene/CE in Postmenopausal Women

The purpose of this clinical trial is to study the blood levels of a drug (conjugated estrogens) in the body from one dosage form compared to another. The four formulations of the study drug that eligible participants will receive will contain the same amounts of the same medications. In addition, information will also be obtained regarding the safety and tolerability of the formulations given to healthy postmenopausal women.


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women aged 35 to 70 years.
* Spontaneous or surgical amenorrhea for at least 6 months.
* Body mass index (BMI) in the range of 18.0 to 35.0 kg/m2 and body weight greater than or equal to 50 kg.

Exclusion Criteria:

* Hypertension or elevated supine blood pressure (\>139 mm Hg systolic or \>89 mm Hg diastolic).
* History of any clinically important drug allergy.
* Use of any prescription or investigational drug within 30 days before test article administration.
The Pre-operative Pathway in Pancreatic Head Malignancy-assessment of the Diagnostic Accuracy of Staging CT Scan

Our aim is to assess the ability of scans to distinguish the organ of origin of pancreatic head malignant tumours and to predict the resectability based on the preoperative imaging. To achieve this, a retrospective review of the preoperative CT scans will be conducted for all patients with pancreatic head malignancy treated at the Peninsula Hepato-Pancreatico-Biliary (HPB) cancer unit between January 2006 till January 2014.

Pancreatic cancer arises from the glandular part of the pancreas and is the fifth most common cause for cancer related death in the UK. It. Ampullary carcinoma arises from the epithelium of the ampulla of Vater into which the common bile duct and pancreatic duct drain. Cholangiocarcinoma arises from the bile duct epithelium, and may occur within the intra-pancreatic portion of the distal common bile duct mimicking a pancreatic malignancy. Cancers arising from these origins often cause obstructive jaundice and are hard to distinguish. Surgery is indicated for the treatment of these types of malignant tumours, and the definitive final diagnosis is usually not known until the specimen is examined. This situation does not allow specific treatment to be given pre-operatively, so-called 'neo-adjuvant therapy'. The rationale for this approach is that in a proportion of patients the tumour will be made smaller by this treatment, which may facilitate surgical resection.

Eligibility Criteria:
Inclusion Criteria:

* All patients who have undergone surgery for presumed pancreatic malignancy in Derriford Hospital between Jan 2006 and Jan 14 will be included.

Exclusion Criteria:

* Not applicable
T-Cell Mitochondrial Respiration Response to Ketone Monoester Supplement in Healthy Volunteers and COVID-19

T-Cell Mitochondrial Respiration Response to Ketone monoester (Ketoneaid) in Healthy Volunteers and COVID-19


Eligibility Criteria:
Inclusion Criteria:

COVID-19 with ARDS and on the ventilator

Exclusion Criteria:

* Pregnant
* \<18 years
* Steroid use
A Twelve Month Long Term Safety Study to Evaluate the Safety of Albuterol in a Dry Powder Inhaler With Both Repeated and as Needed Dosing

This is a one-year study to look at the safety of a dry powder inhaler with albuterol. After a one-week run in, for the first 3 months subjects will use an inhaler with either albuterol or a dummy drug at regular times four times a day. Then for the last nine months of the study, all subjects will be given the albuterol dry powder inhaler and will use it only when needed to help with breathing problems. Subjects will need to keep a daily diary (both paper and electronic) throughout the study recording any inhaler use and health problems. There will be visits to the study doctor about once a month for a year. This study is intended to show that the albuterol dry powder inhaler works well and is safe for use over a long period of time.

The Sponsor terminated this study due to the need for a modification to the Spiromax device utilized in this study; the problem identified has no impact on patient safety. Exposure ranged from 3 to 49 days with the majority of subjects receiving ≤30 days of double-blind treatment.

Eligibility Criteria:
Inclusion Criteria:

* Documented history of persistent asthma with rescue use of albuterol on average of at least once/ week over the 4-weeks prior to screening.
* Female subjects who are of childbearing potential (as judged by the investigator) must be currently using and willing to continue to use a medically reliable method of contraception for the entire study duration
* General good health
* Capable of understanding the requirements, risks, and benefits of study participation
* Non-smoker for at least one year prior to the screening visit and a maximum pack-year smoking history of 10 years
* Other criteria apply

Exclusion Criteria:

* Pregnancy, nursing, or plans to become pregnant or donate gametes (ova or sperm) for in vitro fertilization during the study period or for 30 days following the subject's last study related visit
* Participation in any investigational drug trial within 30 days preceding the screening visit
* A known hypersensitivity to albuterol or any of the excipients in the formulations.
* History of severe milk protein allergy
* History of a respiratory infection or disorder (including, but not limited to bronchitis, pneumonia, acute or chronic sinusitis, otitis media, influenza, etc) which is not resolved within 1 week prior to the Screening Visit.
* Use of any protocol prohibited concomitant medications for asthma or any protocol prohibited concomitant non-asthma medications
* Inability to tolerate or unwillingness to comply with the protocol requirements.
* History of life-threatening asthma
* Any asthma exacerbation within 3 months of the Screening Visit requiring oral or systemic corticosteroids
* History of life-threatening asthma
* Other criteria apply
Mother's Recorded Voice Versus Dexmedetomidine on Postoperative Agitation

The aim of this study is to compare the efficacy of mother's recorded voice versus dexmedetomidine injection on postoperative agitation in children undergoing elective surgery.

A written informed consent will be taken from the patients' legal guardians.Patients will be assigned randomly to three groups (30 subjects each) to be anesthetized and either randomly assigned to listen to the mother's recorded voice at 2 times (in the holding area 3 minutes before induction of anesthesia till induction of anesthesia is ended) and (during emergence from anesthesia till complete recovery) (Group M) or will be given a single bolus of dexmedetomidine 0.2 µ/kg IV at 2 times (in the holding area 3 minutes before induction of anesthesia) and (at the end of surgery) (Group D) or given the same volume of saline IV at 2 times (in the holding area 3 minutes before induction of anesthesia) and (at the end of surgery) (Group C).To keep blinding, group M will be injected IV with the same volume of saline at the same 2 times as in groups D \& C while in groups D \& C, headphones will be putted as in group M at the same 2 times with no recorded voice.

Eligibility Criteria:
Inclusion Criteria:

* Children (age 4-9 years)
* American Society of Anesthesiologists physical status (ASA) I-II who will be listed for outpatient elective surgery under general anesthesia.

Exclusion Criteria:

* Developmental delays
* Neurological diseases
* Deafness
* Hearing impairment
* Maternal mutism
* Absence of the mother
Randomized Controlled Trial of Acupuncture for Functional Dyspepsia

The purpose of the study is to testify the efficacy of treating functional dyspepsia with acupuncture, and provide evidence for the hypothesis that "Acupuncture effect is based on meridians, and gathering of meridian Qi is the key point."

The purpose of the study is to testify whether acupuncture is effective for functional dyspepsia, through treating functional dyspepsia patient for a month, using different acupoints according to literatures of treating migraine with acupuncture, and using Itopride as controlled group, and try to provide clinical evidence for the hypothesis that"Acupuncture effect is based on meridians, and gathering of meridian Qi is the key point."

Eligibility Criteria:
Inclusion Criteria:

1. Consistent with the diagnostic criteria of functional dyspepsia.
2. Age of a subject is older than 18 and is younger than 65.（including 18 and 65）
3. Did not take any gastroenteric dynamic drugs in the last 15 days, and did not take part in any clinical trial.
4. Informed consent is signed by a subject or his lineal relation.

Exclusion Criteria:

1. Patients with any contraindications of Itopride.
2. Patients who are unconscious, psychotic.
3. Patients with aggravating tumor and other serious consumptive disease, and who are subject to infection and bleeding.
4. With serious protopathy or disease of cardiovascular, liver, renal, gastrointestinal, hematological systems and so on.
5. Pregnant women or women in lactation.