cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of a Home Based Exercise Program on Temporomandibular Dysfunction Syndrome

patients with chronic refractory temporomandibular dysfunction were prescribed home exercise and were followed for 6 months. Pain , mouth opening and Fonseca's were done at day 1 and after 6 months of the study.

Each patient was seen by the rheumatologist who did the following; Full history taking including special habits like chewing gums or biting nails, Pain level measured by visual analogue scale 100 (both at rest and during temporomandibular joint movement) Clinical Examination of the temporomandibular joint including localized tenderness and amount of mouth opening After that the patients were prescribed the rehabilitation program in the form of heat modalities and Transcutaneous electric nerve stimulation on the on the temporomandibular joint, given an individual demonstration of the home based exercises and were given a reminding handout.

The rehabilitation program consisted of the following exercises: lateral deviation, protrusion/retraction and mandibular opening.

Isometric cervical muscle strengthening exercises were also prescribed for the patients.

Assessment of the severity of temporomandibular joint affection using the Fonseca's questionnaire were done twice; the first at the entry point to the study and once again after 6 months.

Eligibility Criteria:
Inclusion Criteria:

* patients suffering painful temporomandibular joint

Exclusion Criteria:

* Patients with history of face trauma
* Patients with surgery at the temporomandibular joint
* Dental procedure in the last 6 months period
* Patients with rheumatic diseases
Clinical Evaluation of the CM-1500 in Postoperative Surgery Patients

The primary objective is to evaluate the the changes in the Relative Index in post abdominal or pelvic surgery patients on the Cardiac Monitor Model CM-1500.

Postoperative hemorrhage incidence can vary depending on the type of surgery, but it can lead to severe clinical complications ranging from mild anemia to fatal hemorrhagic shock. Monitoring and detecting these fluid changes postoperatively can be complicated, and standard operating procedures vary. The Cardiac Monitor, Model 1500 (CM-1500), uses a personalized approach by non-invasively and simultaneously monitoring five (5) physiological parameters.

Eligibility Criteria:
Inclusion Criteria:

* Ability to provide written informed consent
* Ability and willingness to comply with study procedures and duration requirements
* 18 years of age or older
* Undergoing an abdominal or pelvic surgery within the next 10 days

Exclusion Criteria:

* Females who are pregnant or breastfeeding
* Participation in other clinical studies involving experimental drugs or devices
* Undergone an amputation of the left upper extremity
* Diagnosed with Dextrocardia
* Subjects who have a Pacemaker
Development and Validation of New "SNU Illustrated Pain Rating Scale" as a Tool for Postoperative Pain Assessment

The numeric rating scale (NRS), one of the most widely used pain scales in clinical practice, although convenient, is often subject to bias because it requires abstract thinking from both the patient and the evaluator. Compared to numbers, traumatic pain, when visualized appropriately, has potential advantage as a means to indicate and communicate the severity of pain. Given that they are standardized in terms of body parts, wound size, and bleeding volume, illustrations of traumatic pain along with external somatic stimuli that caused it can be used to serve as effective visual anchors to supplement a pain scale by giving more concrete information to the patient. The purpose of this study is to develop Seoul National University Illustrated Pain Scale(SNUIPS) using pictures of traumatic pain, and verify the validity and effectiveness of this scale in comparison with those of NRS.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients undergoing a gynecological or orthopedic surgery under general anesthesia
* Administered with intravenous patient-controlled analgesia for postoperative pain control
* American Society of Anesthesiologists physical status class I-III patients

Exclusion Criteria:

* Contraindicated against fentanyl
* Unable to communicate
* Aged less than 18, or more than 79
* Weighs less than 40kg or more than 89kg
* Has severe heart disease(s)
* Pregnant
Endothelial Function in Patients With Ectatic Compared to Normal Coronary Arteries

The aim of this study is to show the frequency of endothelial dysfunction in patients suffering from ectatic coronary arteries as compared to those who have normal coronary arteries. Should this frequency be significant we would recommend initiating conventional treatment in those patients with ectatic coronary arteries as is the practice in patients with endothelial dysfunction without ectatic arteries


Eligibility Criteria:
Inclusion Criteria:

* Ectatic coronary arteries defined by cardiac catheterization
Can the Use of Ear Plugs and Eye Masks Help to Improve Sleep Quality After Major Abdominal Surgery?

The importance of good sleep has been gaining interest in critically ill patients as poor sleep is associated with increased rates of delirium, non-invasive ventilation failure and stress to the patient.

The use of earplugs and eye masks has been shown to result in longer sleep time and better sleep quality. The primary outcome of this randomized control trial is to evaluate if the use of eye masks and earplugs in patients undergoing major abdominal surgery will lead to improved sleep quality. Secondary outcomes include the level of noise intensity in the various monitored units, incidence of delirium, nursing demand, length of hospitalization and anaesthetic techniques. With these findings, we hope to be able to improve patients' overall satisfaction with the healthcare received.

The importance of good sleep has been gaining interest in critically ill patients as poor sleep has been found to be associated with increased rates of delirium, non-invasive ventilation failure, and may serve as a stressor to patients. The use of earplugs and eye masks to improve sleep quality has been described in the critically ill patient population and outcomes have suggested that such interventions have resulted in longer sleep time and Rapid Eye Movement sleep, shorter sleep onset latency and less awakenings, with an enhanced perceived sleep quality. In the post-anaesthesia care unit, these interventions have also led to significantly preserved sleep quality in patients. The primary outcome of this randomized control trial is to evaluate if the use of eye masks and earplugs in patients undergoing major abdominal surgery, and who will be admitted to a monitored unit postoperatively, will lead to improved sleep quality. Secondary outcomes evaluated include the level of noise intensity in the various monitored units (Intensive Care Unit/Intermediate Care Area/High Dependency Ward), incidence of delirium, nursing demand, length of hospitalization and anaesthetic techniques. With these findings, we hope to be able to improve patients' overall satisfaction with the healthcare received.

Eligibility Criteria:
Inclusion Criteria:

* All patients who are 21 years old and above, undergoing elective major abdominal surgery in Singapore General Hospital, and who are anticipated to require a monitored bed postoperatively will be identified via Operating Theatre Management system the day before surgery. Postoperatively, these patients must have a Glasgow Coma Scale of at least 10, able to obey verbal commands and stay in a monitored unit postoperatively (Intensive Care Unit/Intermediate Care Area/High Dependency).

Exclusion Criteria:

* Patients who have known hearing impairment, dementia, confusion, delirium or with a tracheostomy will be excluded.
Telitacicept Followed With Rituximab Therapy on APS Secondary to SLE

The aim of this study was to observe the clinical efficacy and safety of rituximab (RTX) combination with telitacicept (TA) in patients of systemic lupus erythematosus secondary antiphospholipid syndrome (APS).

In this multicenter, prospective, observational study, 80 patients with SLE Secondary APS patients were enrolled. RTX alone or its continuation with TA was observed for 24weeks，and extended for another 24 weeks. At week 12, the RTX group could be converted to the combination group. The primary end point was the response rate of total antiphospholipid antibody (aPL) at week 12. The secondary end points included the decline rate and value of aPL antibody, aGAPSS score, remission degree of specific clinical indicators, changes in SLE disease activity in SAPS group, and drug safety at week 12 and week 24.

Eligibility Criteria:
Inclusion Criteria:

* 1.Patients who meet 2006 Sapporo classification criteria of APS or 2020 nonstandard APS performance；

  2.Patients who meet 1997 or 2019 SLE classification criteria ;

  3.Positive LA /ACL/ aβ2GPI ,on two or more occasions, at least 12 weeks apart;

  4.with at least one extra-criteria manifestations of APS, including thrombocytopenia, hemolytic anemia, nephropathy, valve heart disease ,skin ulcer and arterial or deep vein thrombosis;

  5.Maintain a stable base treatment regimen for at least 4 weeks before screening; Basic treatment includes anticoagulants/antiplatelet agents, glucocorticoids, and hydroxychloroquine;

  6.No response, intolerance or dependence on glucocorticoids and immunosuppressants;

  7.Patients who had previously used beliumab or Telitacicept could be enrolled in the study after 12 weeks of discontinuation;

  8.Age ≥18 years;

  9.Signed Informed consent.

Exclusion Criteria:

* 1.Patients with other causes of thrombocytopenia, hemolytic anemia, valvular heart disease, kidney disease and skin ulcer symptoms were excluded, such as drugs, infections, blood system diseases, genetic metabolic diseases, etc;

  2.Severe cardiovascular diseases, kidney, liver and other important organ injuries, serious blood and endocrine system lesions (aplastic anemia, hyperthyroidism crisis, etc.) were excluded; A history of active malignancy (within 5 years) was excluded and chemoradiotherapy was performed; Patients with organ or bone marrow transplantation in the past year were excluded. Exclusion of mentally ill persons;

  3.A history of allergy to the relevant test drug;

  4.Patients had recently received a live vaccine or planned to use any live vaccine during the study;

  5.Ongoing pregnancy;

  6.Patients who were participants in clinical trials of other immunosuppressive agents/biologics within 24 weeks;

  7.Other conditions that the investigator considers would make the candidate unsuitable for the study;
Laboratory Assay in Determining Cancer Resistance in Patients With Metastatic Cancer and in Healthy Participants

RATIONALE: Studying samples of blood and tissue in the laboratory from patients with cancer and from healthy participants may help doctors learn more about cancer.

PURPOSE: This laboratory study is looking at an assay in determining cancer resistance in patients with metastatic cancer and in healthy participants.

OBJECTIVES:

* Optimize and standardize the in vitro cell kill assay using human white blood cells and human cancer cell lines from patients with metastatic cancer and from healthy participants.
* Determine the results of the in vitro cell kill assay in patients with metastatic cancer and in healthy participants with no history of cancer.

OUTLINE: This is a pilot study.

Peripheral blood is obtained from healthy participants and from cancer patients. Tissue is collected from archived samples. White blood cells are obtained from tissue and blood samples and are assessed by the in vitro cell kill assay.

PROJECTED ACCRUAL: A total of 24 patients and 24 healthy participants will be accrued for this study.

Eligibility Criteria:
Inclusion Criteria:

-Meets 1 of the following criteria:

* Diagnosis of metastatic cancer including, but not limited to, any of the following:

  * Stage IV non-small cell lung cancer
  * Extensive-stage small cell lung cancer
  * Metastatic testicular cancer
  * Stage IV breast carcinoma
  * Stage III or IV ovarian carcinoma
  * Stage IV endometrial carcinoma
  * Stage IV prostate carcinoma
  * Stage IV colorectal or pancreatic cancer
  * Stage IV renal cancer
  * Stage III or IV non-Hodgkin's lymphoma
  * Stage IV bladder cancer
  * Stage III multiple myeloma (Salmon-Durie staging)
  * Metastatic melanoma
  * Metastatic sarcoma
* Healthy participant, meeting the following criteria:

  * No prior cancer
  * Over 50 years of age

Exclusion Criteria:

* Serious medical or psychiatric condition that would preclude study compliance
* Chemotherapy or radiotherapy within the past 3 months (patient)
* Prior immunosuppressive therapy or radiotherapy for any disease (healthy participant)
Investigation of Safety and Efficacy of SB Injection in Patients With Advanced and Metastatic Non-small Cell Lung Cancer

The purpose of this study is to determine efficacy of SB injection in Non Small Cell Lung Cancer.

All eligible patients will receive SB injection therapy for 4 cycles (14\~21 days for each cycle). SB injection treatment could be continue after completion of therapy cycles until 6th cycle. It depends on the investigator's decision and patient's will. Efficacy will be evaluated every two cycles.

Eligibility Criteria:
Inclusion Criteria:

* Age of 18-70 years
* Patients with histologically or cytologically confirmed Non-Small Cell Lung Cancer
* Patients who had failed more than 1 cycle of standard therapy with advanced or metasatic stage not available to any of resectable surgery or radiotherapy.
* Patients with measurable lesions
* Eatern Cooperative Oncolgy Group status 0 to 2.
* Life expectancy \>/= 5 months
* Patients with adequate organ(heart, kidney, liver)and bone marrow function, as defined by

  1. Absolute neutrophil count \>/= 1.5 x 10\^9/L, Platelet count \>/= 100 x 10\^9/L
  2. Total bilirubin \</= upper limit of normal
  3. Aspartate Aminotransferase and/or Alanine Aminotransferase \</= 2 x upeer limit of normal
  4. creatinine \</= 1.5 x upeer limit of normal
* Patients who have signed the informed consent form.

Exclusion Criteria:

* Female volunteers admitted to the study must be using a reliable means of contraception
* Received radiation therapy within 6 weeks before randomization
* Known brain or spinal cord metastases
* Have acute infection
* Have active infection or serious concomitant systemic disorder incompatible with the study
* Presence or history of malignancy other than Non-Small Cell Lung Cancer
* Have severe neurologic or psychological disorder
* Patients who have to receive other chemo-radiotherapy or immunotherapy
* Patients who have received chemotherapy within the previous 30 days
* Patients who are candidates for combined modality treatment.
* Patients who have participated in a clinical study within the previous 30 days
Effects of Micronutrient (Chromium) Supplementation on Diabetes

6-8% of USA population has diabetes. Intensive blood glucose control dramatically reduces the devastating complications that result from poorly controlled diabetes. However, for many patients, achievement of tight glucose control is difficult with current regimens. Trivalent chromium, the form found in foods and dietary supplements, is believed to be safe. Our preliminary studies have reported that chromium supplementation inhibits the increase in pro-inflammatory cytokines (tumor necrosis factor-alpha and interleukin-6; TNF-alpha and IL-6) secretion levels caused by high glucose levels in cultured monocytic cells. Similarly, animal studies have shown that chromium niacinate supplementation lowered blood levels of glycemia and pro-inflammatory cytokines in streptozotocin-treated diabetic rats. Cytokines are proteins that are secreted by monocytes and other cells in response to various stimuli, such as infection. Some of the cytokines are known to regulate insulin sensitivity and elevated level of these cytokines in blood may accelerate clogging of arteries. Thus, chromium supplementation may increase insulin sensitivity and glycemic control in diabetic patients, and may prevent the development of cardiovascular disease in diabetic patients. Given the enormous public health cost of diabetes, the prospect of being able to use a relatively low-cost dietary supplement, such as chromium, as an adjuvant therapy to help in achieving normal blood glucose level merits further study.

We will examine the effects of placebo and chromium niacinate supplementation on the fasting glucose, cholesterol, triglycerides, and markers of vascular disease in blood of diabetic patients. We will determine these above parameters at baseline and after the 1, 2 and 3 months of supplementation in diabetic patients. The long-term objective is to explore the efficacy of chromium as an adjuvant treatment for better glycemic control, prevent the development of cardiovascular disease (CVD), and improve the life expectancy in diabetic population.

Chromium supplements are widely used by the public and are available in many stores, such as Wal-mart, Walgreens, and many other food and drug stores. Chromium is an essential trace metal and micronutrient present in wide variety of vegetables. Niacin is a vitamin B6, an essential vitamin for our body. This study plans to use chromium niacinate, a complex of chromium and niacin. Chromium niacinate is considered a nutrient.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Type 1 diabetes mellitus
* Participants between the ages of 8 and 21

Exclusion Criteria:

* Subjects with sickle cell disease, renal or liver disease
* Serum positive pregnancy test or breastfeeding
* Participants unwilling/unable to take supplements in pill form
* Participants taking prescription medication or supplements
Pediatric Veins Cannulation Technique

multicenter, prospective and cohort study to evaluate infrared technology for identifying and and indwelling peripheral veins in 0 up to 4 years old children.

AIM OF THE STUDY The primary objective of this study is to determine the success rate at first attempt of peripheral veins cannulation in small children (\<5yrs) and infants (\<1yr) of Veinsite compared with traditional palpation method performed by skilled operators.

The secondary objective of this study is to determine the time to cannulation using the two techniques, the difference in visualized veins using the Veinsite or the direct visualization and palpation of the patients' skin, cannula indwelling time and complications related to the procedure.

DESIGN Prospective randomized controlled study

Population

It is expected to recruit 60 pediatric patients undergoing peripheral vein cannulation with known difficulties according the difficult venous access score (DIVA) (6) in the following centers:

1. Fondazione IRCCS Istituto Neurologico "C.Besta" , Milano
2. Ospedale Pediatrico Bambino Gesù, IRCCS, Roma

Duration of study Patient will be followed from the day of peripheral vein cannulation till the peripheral cannula will be removed (max 3 days) in order to assess any cause of venous extravasation. The recruitment phase is supposed to be 6 months after achieving the ethical-administrative authorization.

Eligibility Criteria:
Inclusion Criteria:

* Male and Female children from 1 month to 5 years Of age
* American Society of Anesthesiologists Classification (ASA) I: without systemic disease
* American Society of Anesthesiologists Classification (ASA) II: moderate systemic disease
* American Society of Anesthesiologists Classification (ASA) III: severe systemic disease that limits normal activity, without invalidity.
* Scheduled for any indication of peripheral venous line placement
* Admission to an Intensive Care Unit, Neurosurgery ward or pediatric ward of one of the hospitals included
* Children whose parents (or legal tutors) have given their informed written consent

Exclusion Criteria:

* Any contraindication for peripheral line placement
* Children whose parents (or legal tutors) denied their own consensus
Perioperative Inflammation and Cyclooxygenase 2 (COX-2)

Surgery initiates a complex cascade of events involving the release of chemical compounds from nerve endings and damaged tissue which leads to an inflammatory and pain response. The purpose of this investigation is to measure various chemical mediators in the blood and cerebrospinal fluid, and to test the hypothesis that they will be decreased in patients treated with a COX-2 inhibitor.

Surgery initiates a complex cascade of events involving the release of nociceptive compounds from nerve endings and damaged tissue which leads to an inflammatory and hyperalgesic response. COX-2 inhibitors are often used for treating pain. This is a double-blind randomized study in surgical patients receiving a spinal drain for surgical purposes. The hypothesis is that valdecoxib will reach therapeutic concentrations in CSF, and will decrease plasma and CSF concentrations of inflammatory mediators. Subjects will receive valdecoxib 40 mg or placebo approximately 1 hr prior to surgery. Serial blood and CSF samples will be obtained. Valdecoxib and cytokine concentrations will be measured.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing surgery requiring lumbar drain placement

Exclusion Criteria:

* Contraindication to COX-2 inhibitor (renal or hepatic insufficiency)
* Known adverse reaction to nonsteroidal anti-inflammatory drugs (NSAIDs)
* Use of NSAID or COX-2 within 7 days prior to surgery
Efficacy of Nebulized Hypertonic Saline in the Treatment of Acute Bronchiolitis

The purpose of this study is to evaluate the efficacy of hypertonic saline vs. normal saline in the treatment of infants hospitalized for bronchiolitis, regarding length of hospital stay, oxygen requirements and clinical outcome.

Despite bronchiolitis is a very frequent disease among infants, there are still controversies regarding its treatment. Hypertonic saline has been proposed as useful treatment in these children, bur information is still controversial.

The aim is to asses that using Nebulized Hypertonic Saline with bronchodilators (albuterol) may reduce the days of hospitalization and improve clinical outcomes in patients with acute bronchiolitis, compared with using Normal Saline with albuterol.

Eligibility Criteria:
Inclusion criteria:

* Infants aged 1 to 24 months, hospitalized for first episode of bronchiolitis, with severity score ≥ 5 points and oxygen saturation ≥ 97%.

Exclusion Criteria:

* Chronic respiratory or cardiovascular disease, respiratory failure.