cyrilzakka/clinical-trials huggingface dataset:
DNIC Using Deep Learning and Artificial Intelligence

Chronic pain (CP) is disabling for people triggering important costs for society. A deficit of diffuse noxious inhibitory controls (DNIC) is one of the CP mechanisms. DNICs are evaluated in research setting using a CPM protocol (conditioned pain modulation). There is a lack of reference values on the effectiveness of DNICs. Wider research on DNIC will help to understand CP and to develop a clinical screening test evaluating DNICs. This study aims more specifically to determine whether it is possible to develop a facial recognition system to automate pain measurement and the effectiveness of pain control mechanisms.

This study aims:

1. To develop and validate a predictive tool (using deep learning and artificial intelligence) to estimate the efficacy of pain control mechanisms.
2. To estimate references values for facial expressions of pain control mechanisms in healthy and in chronic pain participants.

The target population will be healthy volunteers and volunteers with chronic pain, male and female, stratified by age.

The reference values (healthy volunteers) will be established via a non-parametric method for a standard conditioned pain modulation (CPM) protocol in which two "stimuli tests" of the same intensity and nature (heat) will be applied before and after the application of another "conditioning stimulus" (cold water bath). The perceived pain difference between the 1st and 2nd stimuli tests will reflect the intensity of the DNICs. Participants' facial expressions will be captured simultaneously by three cameras during the CPM testing.

These results will be compared to those from volunteers suffering with chronic pain. The clinical decision rule will result from clinical and paraclinical elements correlating with the amplitude of the efficacy of CPM (serum noradrenaline, intensity of pain, heart rate and blood pressure measurements, psychometric questionnaires assessing anxiety, depressive feelings and pain catastrophizing). Logistic regression analysis will determine the best predictors of a CPM deficit.

Eligibility Criteria:
Healthy participants

Inclusion Criteria:

* 18-79 years old
* No chronic pain
* Able to provide consent

Exclusion Criteria:

* Cardiovascular disease (arrhythmia, cerebrovascular accident, infarction...)
* Raynaud syndrome
* Severe psychiatric disease (dementia, schizophrenia, psychosis, major depression)
* Injuries or loss sensitivity to their forearms or hands
* Pregnant women or in post-partum period (\<1 year)

Participants with chronic pain

Inclusion Criteria:

* 18-79 years old
* Chronic pain (chronic pain is defined by any regular pain for more than 6 months)
* Able to provide consent

Exclusion Criteria:

* Cardiovascular disease (arrhythmia, cerebrovascular accident, infarction...)
* Raynaud syndrome
* Severe psychiatric disease (dementia, schizophrenia, psychosis, major depression)
* Injuries or loss sensitivity to their forearms or hands
* Pregnant women or in post-partum period (\<1 year)
* Chronic pain caused by cancer or migraine
TACE Combined With Lenvatinib and MWA in the Treatment of Locally Advanced Large Hepatocellular Carcinoma

To explore the objective effectiveness and safety of TACE combined with Lenvatinib in the treatment of advanced liver cancer. After successful down-stage, radical microwave ablation was further performed.

The purpose of this study is to explore the objective effective rate of TACE combined with Lenvatinib in the treatment of locally advanced liver cancer, so as to provide a new idea for the radical microwave ablation treatment mode after the decline of locally advanced liver cancer.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-75 years with hepatocellular carcinoma have an expected survival of at least 3 months;
* Number of tumors ≤ 3;
* Large hepatocellular carcinoma with tumor diameter ≥ 7 cm;
* Patients without inferior vena cava tumor thrombus, portal vein tumor thrombus and cholangiocarcinoma thrombus;
* Although there is arteriovenous fistula or arterioportal fistula, it can be completely blocked;
* Child Pugh grade A or B of liver function; ECoG physical fitness score \< 2;
* No bleeding tendency, normal coagulation function or coagulation dysfunction can be corrected after treatment;
* Leukocyte count ≥ 3.0 × 109/L；
* Hemoglobin ≥ 8.5g/dl;
* Platelet count ≥ 50 × 109/L；
* The international normalized ratio of prothrombin time (INR) ≤ 2.3 or prothrombin time (PT) does not exceed the upper limit of normal control for 3 seconds;
* Serum creatinine was less than 1.5 times of the upper limit of normal;
* Patients and / or family members agree to join the clinical trial and sign the informed consent form

Exclusion Criteria:

* Diffuse hepatocellular carcinoma;
* Portal vein tumor thrombus;
* Combined with tumor thrombus of hepatic vein and inferior vena cava;
* Patients with lymph node metastasis and extrahepatic distant metastasis;
* The liver function was classified as child Pugh C and could not be improved by liver protection treatment;
* Arteriovenous fistula or arterioportal fistula with ineffective intervention;
* Uncorrectable coagulation dysfunction and obvious hemogram abnormalities, with obvious bleeding tendency;
* Intractable massive ascites;
* ECoG physical fitness score \> 2 points;
* Combined with active infection, especially bile duct inflammation;
* Serious heart, lung, kidney, brain and other important organ diseases;
* Note: see attached table 1 for child Pugh classification of liver function; See attached table 2 for ECoG physical fitness score
Topical Hydrocortisone for Pain and Edema Control After Third Molar Surgery

The investigators set out to develop a clinical trial in order to test the topical use of hydrocortisone as a intraoperative irrigant solution. As this route of administration as well as being low cost and not add new steps to the surgical procedure, can contribute to an improved quality of life in the postoperative period of patients undergoing extraction of third molars.

Third molars are the teeth with a higher prevalence of failure in eruption and surgery for extraction of these impacted teeth is one of the most commonly procedures performed by the oral and maxillofacial surgeon. In most cases these are not traumatic procedures, however factors such as patient age, habits, degree of tooth impaction and surgeon experience can influence the surgical trauma and therefore the postoperative period could include swelling and pain of varying magnitudes which can significantly affect the patient's quality of life.

The study is designed as a prospective, randomized, placebo-controlled, split-mouth crossover trial. All the patients will be informed of the experimental methodology and signed a institutionally approved consent form. The study is been conducted in compliance with Declaration of Helsinki (1989), and was revised by the Institutional Ethical Committee (protocol 1.167.908).

Eligibility Criteria:
Inclusion Criteria:

* Health patients of any sex, with symmetric bilateral bone-impacted mandibular third molars requiring surgical removal, and with no history of allergy to the drugs used in this study.

Exclusion Criteria:

* Use of analgesic or anti-inflammatory drugs 24 hours before the surgery.
* Pregnant or breastfeeding patients,
* Use of other drugs beyond of that one's prescribed by the researchers;
LIFSCREEN : Evaluation of Whole Body MRI for Early Detection of Cancers in Subjects With P53 Mutation (Li-Fraumeni Syndrome)

The purpose of this study is to compare the diagnostic efficacy of two follow-up schedules for the early detection of cancers in the population under study on cancer incidence at 3 years.


Eligibility Criteria:
Inclusion Criteria:

* P53 mutation
Etiology Of Recurrent Varicose Veins After Stripping Or Ablation Of Superficial Venous System

Number of patients and causes and patterns of recurrent varicose veins in the lower limbs in patients with history of varicose veins stripping or ablation of the superficial venous system.

Recurrence of varicose veins following surgery is a common, complex and costly problem in vascular surgery. Despite improvements in preoperative evaluation and methods of treatment, recurrence following varicose vein surgery is reported to occur in between 20 and 80% of cases. Many theories have been put forward concerning the underlying mechanisms and causes. These include poor understanding of the venous anatomy and haemodynamics, inadequate preoperative assessment, inappropriate or incomplete surgery and development of new sites of venous reflux as a consequence of disease progression or neovascularisation. However, it is difficult to evaluate these suggestions since the studies from which they arise vary greatly in their definitions of recurrence, preoperative assessment, initial treatment, classification and method and duration of follow-up.

Eligibility Criteria:
Inclusion Criteria:

* 1) Ages eligible for the study: 18-60. 2) Sexes eligible for the study: All. 3) Patients with previous intervention for varicose veins. 4) Patients with primary or secondary varicosities. 5) Patient's compliance to follow-up.

Exclusion Criteria:

1) Patients with no history of interventions for varicose veins. 2) Patients treated with injection sclerotherapy alone. 3) Pregnant women. 4) Patients with arterial disease in the same limb (ABI \<0.8). 5) Patients with post-thrombotic syndrome

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Tranexamic Acid in HIp Fracture Surgery (THIF Study)

The purpose of this study is to assess the efficacy of tranexamic acid in hip fracture surgery on the reduction of allogeneic red blood cell transfusion.

Studies in hip and knee arthroplasty (scheduled surgery) have shown that tranexamic acid decreases allogeneic red blood cell transfusion. In hip fracture surgery, an emergent procedure, transfusion is frequent. Transfusion increases adverse events such as postoperative bacterial infection and venous thrombosis. The purpose of this study is to assess the efficacy of tranexamic acid, an anti-fibrinolytic agent, in hip fracture surgery on the reduction of allogeneic red blood cell transfusion. The trial will also evaluate if the reduction in transfusion will be associated with less postoperative infection and without an increase in the thrombotic risk.

Patients with an isolated hip fracture of less than 48 hours will be randomized to either tranexamic acid 15mg/kg IV at skin incision and three hours later or saline.Patients will receive fondaparinux for prophylaxis of venous thrombosis.

Eligibility Criteria:
Inclusion Criteria:

* Patient requiring surgery for an isolated hip fracture of less than 48 hours

Exclusion Criteria:

* Contraindication to tranexamic acid
* Contraindication to fondaparinux
* Contraindication to general anesthesia associated with a femoral nerve block
* pregnancy
The Effect of Music on Quality of Life in Fibromyalgia Patients

This study's aim was to determine the effect of music therapy on symptoms and functions in patients with fibromyalgia syndrome (FMS).

This study's aim was to determine the effect of music therapy on symptoms and functions in patients with fibromyalgia syndrome (FMS). Women diagnosed with FMS for at least 6 months included in the study. 16 patients were in the music treatment group and 51 patients were in the control group. Patients in music treatment group were given a music CD which includes nature sounds recommended by the Turkish Psychological Association. The patients were evaluated with Fibromyalgia Impact Questionnaire (FIQ) before and after the treatment.

Eligibility Criteria:
Inclusion Criteria:

* Female patients over the age of 18
* Being diagnosed as FMS according to 2010 American College of Rheumatology (ACR) criteria for FMS
* Having the diagnosis of FMS at least six months

Exclusion Criteria:

* Patients with hearing problems, pregnancy, another accompanying central sensitization syndrome or schizophrenia
* Patients with psychiatric illness
* Patients whose pharmacological treatment for FMS changed within the last three months
* Patients without a listening device
* Patients who do not have a cognitive level to answer the questions in the scale
Study of Advanced Bulky Malignancies With Spatially Fractioned Radiation Therapy

Expand clinical literature on the use of Grid radiation with conventional external beam therapy. Vast majority of therapy is for palliative care to provide relief from pain, but has also shown a reduction in the size of tumor mass.

This study will evaluate response to radiation therapy by a large bulky tumor is influenced by adding a single dose of 15 Gy grid radiotherapy. To accomplish this, patients with large bulky tumors in the lung, abdomen or pelvis will be randomized to receive either standard palliative radiation or palliative radiation plus a single fraction of grid radiation. Tumor response, pain relief and duration of response, and pain control will be monitored. Toxicity of treatment will also be followed. The hypothesis of this study is that grid radiation will produce a significant improvement in tumor response and pain control that produces no further increase in acute or late toxicity.

Eligibility Criteria:
Inclusion Criteria:

* Patients with histologic or cytologic diagnosis of primary or metastatic epithelial cancer or sarcoma located in the head and neck area, lung, abdomen or pelvis.
* Tumors must have an overall dimension greater than 24 cm2 (bidimensional) with one dimensions \>6 cm, by x-ray, CT/MRI scan or clinical exam.
* Age \>18
* Karnofsky \> 70 with life expectancy \>3 months.
* Patients may not begin new hormone therapy within 2 weeks of initiation of protocol treatment.
* No planned initiation of hormone therapy within 2 weeks of protocol therapy
* Adequate bone marrow function: Hb \> 9, white blood cell count (WBC) \> 2,000. Hepatic function \< 3x upper limit of laboratory normal values.
* Laboratory studies will be obtained within 2 weeks prior to randomization.
* Patients with metastatic sites of disease including brain are eligible provided that life expectancy is \> 3 months.

Exclusion Criteria:

* Hematologic-related tumors.
* Tumors overlying critical central nervous system structures including spinal cord, eye or brainstem or require treatment portals over these vital structures.
* Central nervous system tumors
* Evidence of other primary malignancy except for carcinoma in situ of cervix or skin cancer excluding melanoma unless disease free for 2 years prior to randomization
* Patients with spinal cord compression.
* Prior radiation to treatment field.
* Concomitant chemotherapy or chemotherapy within past 2 weeks. Planned initiation of chemotherapy within 2 weeks of completing protocol treatment
A Study to Assess the Safety and Performance of SurgiClot® in the Treatment of Cancellous Bone Bleeding

The purpose of this European study is to demonstrate the safety and performance of the SurgiClot® dressing in the treatment of cancellous bone bleeding.

Patients who require surgery for iliac crest bone graft (ICBG), pelvic osteotomy or spinal fusion will be screened for this multicenter, prospective, non-randomized, open-label study. All qualified subjects will be treated with the SurgiClot® haemostatic dressing (a completely soluble dressing consisting of solid nanofibers of electrospun dextran with embedded lyophilized human fibrinogen and thrombin proteins).

The safety and performance of the SurgiClot dressing will be evaluated in up to 40 subjects enrolled in Europe. Subjects will be followed for six weeks after the surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing a planned elective orthopaedic or spinal surgical procedure. Spinal surgery can be the entire spine although it should be confined to one or two-level fusions e.g. one or two level cervical, or thoracic or lumbar.
* Patient has an intraoperative bleeding site involving cancellous bone that the surgeon would typically treat with another topical haemostatic agent to control the bleeding.
* Patient has normal liver function
* The subject is willing and able to comply with the requirements of the study protocol, including the six weeks follow-up evaluation.

Exclusion Criteria:

* Is unable or unwilling to return for the follow-up visit.
* The subject has had surgery at the intended application site ≤ 6 months before the current surgical procedure.
* Active infection at the surgical site.
* Pregnancy, as determined by urine pregnancy test, or breast feeding.
* Pre-operative platelet count \< 150,000, INR \> 1.3, and/or APTT \> 32.4.
* Pre-operative anaemia (Hb \< 110 g/L in females, Hb \< 120 g/L in males).
* Use of anticoagulant therapy (e.g., coumadin, heparin, clopidogrel), non-steroidal anti-inflammatory medications or fish oil supplements within 7 days of the surgery except for aspirin. (maximum dose 150 mg per day)
* Patient with a blood dyscrasia.
* Presence of a spinal tumour, intradural pathology, or prior spinal fusion surgery at the same target site.
* Participation in another clinical trial with an investigational drug or device within the past 30 days.
* Known allergy to human fibrinogen, human thrombin, or porcine-derived products.
* Compromised immune system.
* The use of a haemostatic agent is contraindicated for the subject.
* Fibrinolytic disorders requiring intraoperative antifibrinolytic treatment.
* Haematological disease (thromboembolic events, haemoglobinopathy, coagulopathy or haemolytic disease)
* Significant co-morbidities: Previous myocardial infarction (MI); severe ischemic heart disease (New York Heart Association Class III, IV); severe pulmonary disease; chronic renal failure; hepatic failure; uncontrolled hypertension.
* Subject is unwilling to receive blood products.
A Post-Marketing Surveillance Study to Assess Safety of Ozanimod in Patients With Moderate to Severe Active UC in Korea

The purpose of this observational study is to assess the real-world safety of ozanimod in Korean participants with moderate to severe active ulcerative colitis.


Eligibility Criteria:
Inclusion Criteria:

* Adult participants 19 years of age or older
* Participants who will receive ozanimod according to the approved label after enrollment
* Participants who sign the informed consent form voluntarily

Exclusion Criteria:

* Participants who are prescribed ozanimod for therapeutic indications not approved in Korea
* Participants for whom ozanimod is contraindicated as clarified in Korean prescribing information approved by Ministry of Food and Drug Safety
Prospective Multicenter Study to Characterize the REAL-WORLD EVIDENCE Regarding Safety and Performance of the PTCA Catheters Family

The purpose of this Post market Study is to collect clinical data of the Arthesys PTCA catheters family during angioplasty intervention of coronary vessels or coronary bypass graft stenosis to support MDR submission.


Eligibility Criteria:
Inclusion Criteria:

* Patient with a Percutaneous intervention to a native coronary or coronary bypass graft indication
* Patient \>18 years
* Patient who understands the trial requirements and the treatment procedures and provides written informed consent

Exclusion Criteria:

- Patients will not be included if they are under judicial protection, guardianship or curatorship or if they are deprived of their liberty by judicial or administrative decision.
To Evaluate the Efficacy and Safety of SHR0302 Tablet in Subjects of Active Psoriatic Arthritis

This study is a phase 3 study,to evaluate the efficacy and safety of different doses of JAK1 inhibitor SHR0302 in subjects with active psoriatic arthritis.


Eligibility Criteria:
Inclusion Criteria:

1. Provide signed informed consent；
2. Diagnosis of PsA fulfillment of the Classification Criteria for PsA (CASPAR) criteria with symptom onset at least 6 months prior to the Screening Visit；
3. Active arthritis at screening/baseline as indicated by \>/= 3 tender/painful and 3 swollen joints；
4. Diagnosis of active plaque psoriasis or documented history of plaque psoriasis.

Exclusion Criteria:

1. History of other autoimmune diseases; history of cancer or infection including tuberculosis and hepatitis; history of important cardiovascular events or thrombotic diseases；
2. Non-plaque forms of psoriasis (with exception of nail psoriasis)；
3. Previous treatment with cytotoxic drugs; JAK inhibitor or bDMARDs within 6 months of randomization.
Comparison of Single and Repeated Dose of Vaginal Misoprostol for the Treatment of Early Pregnancy Failure

A randomised controlled trial assessing the efficacy of single versus repeated dose of vaginal misoprostol for the treatment of early pregnancy failure.


Eligibility Criteria:
Inclusion Criteria:

* Women with early pregnancy failure, defined as missed abortion or blighted ovum, seeking medical treatment with misoprostol.
* Age equal or greater than 18 years
* Gestational age less than 12 complete weeks.

Exclusion Criteria:

* Complete, incomplete, inevitable, or septic abortion.
* Hemodynamically unstable patients.
* Misoprostol sensitivity or contraindication.
* Multifetal pregnancies.
Nebulized Hypertonic Saline for Inpatient Use in COPD

A comparison of albuterol treatments using hypertonic saline (3%) versus standard saline (0.9%) in patients with admitted patients COPD in regard to Modified Borg Dyspnea scale scores after 4 treatments within 24 hours.

Hypothesis:

A clinically significant difference exists between albuterol treatments with nebulized 3% saline versus standard saline, for improvements in the patient's modified Borg dyspnea score during an acute exacerbation of COPD.Study

Population:

This study will involve 146 patients admitted to Doctors Hospital in Columbus, Ohio from September 2014 through September 2015 with a clinical diagnosis of an acute exacerbation of COPD, defined as an increase in the patient's dyspnea, cough, or change in sputum consistency/volume/color from the patient's baseline during stable conditions.

Study Design:

Patients will be randomly assigned to 2.5 mg albuterol treatments with either normal saline, as is the standard, or hypertonic saline.

Once the patient is enrolled, they will be randomly assigned to 2.5 mg albuterol treatments with either normal saline, as is the standard, or hypertonic saline. They will then receive the 2.5mg albuterol treatment, and saline solution as determined by the randomization plan (Group 1 will receive 0.9% saline and Group 2 will receive 3% saline), every six hours for at least the first 24 hours, with allowance for PRN (pro re nata= as needed) use every four hours by patient request.

The patient's dyspnea will be evaluated prior to starting the treatment and after the intervention period is completed using the Modified Borg Dyspnea Scale.

Eligibility Criteria:
Inclusion Criteria:

* Patients at least 18 years of age
* Admitted to Doctors Hospital with a clinical diagnosis of COPD
* Documented obstruction on spirometry from prior records available at the time of the study.

Exclusion Criteria:

* Patients younger than 18 years of age
* Spirometry data not available
* History of smoking less than twenty pack-years
* Possibility of other primary cause of the patient's change in dyspnea or cough (e.g. pneumonia, congestive heart failure with pulmonary edema, myocardial infarction)
* Patient is found to have a different primary cause after initial enrollment
* Non-English speaking subjects