cyrilzakka/clinical-trials huggingface dataset:
Vitamin d Level and it's Association With Disease Activity in Egyptian Rheumatoid Arthritis Patients

Vitamin D level and its association with disease activity in Egyptian Rheumatoid arthritis (RA) patients

Rheumatoid arthritis (RA) is a chronic inflammatory disease that affects about 1% of the human population. Its incidence increases between 25 and 55 years and is the most common type of chronic inflammatory arthritis . It affects joints bilaterally with synovial hyperplasia, cartilage erosion, bone destruction, and progressive loss of function . also characterized by systemic features and joint involvement. It can lead to significant morbidity and mortality so early diagnosis and proper treatment are crucial in decreasing the burden of this disease . According to the World Health Organization mortality database of 31 countries, RA accounts for almost 18% of all deaths caused by different types of arthritis and other musculoskeletal diseases, but the exact cause of RA remains unknown

Eligibility Criteria:
Inclusion Criteria:

* Both males and females in the age group of 1875 years having RA according to the American College of Rheumatology European League Against Rheumatism 2010 criteria (Meena et al., 2018). Will enrolled in this study

Exclusion Criteria:

* Patients with malnutrition, hepatic and renal dysfunction, hyperparathyroidism, hyperthyroidism, diabetes mellitus, and patients on Vitamin D supplementation in the past 6 months or on medications that can affect bone and Vitamin D metabolism (anticonvulsants, diuretics, and thyroxin) were excluded from this study.
* Patients with overlap syndrome
* known allergy to DMARDs, 1,25 dihydroxy vitamin D3 or calcium supplements
Investigation of Relationship Between Vascular Functions, Exercise Capacity, and Respiratory Functions in CF

In the literature, there is no study that evaluates the endothelial function and arterial stiffness together and investigates its relationship with exercise capacity and respiratory functions in children with CF of different obstruction severities. Therefore, the aim of this study is to investigate and compare microvascular (endothelium), macrovascular (arterial stiffness) functions in children with CF of different obstruction severities, and to investigate the relationship between micro and macrovascular functions and exercise capacity and respiratory functions in children with CF of different obstruction severities.

Cystic fibrosis (CF) is a rare disease with congenital deterioration in mucociliary clearance that causes recurrent or chronic rhinosinusitis, airway infection and bronchiectasis in pediatric age. There are pulmonary genetic disorders associated with inflammation. Children with CF have been shown to have vascular endothelial dysfunction compared to healthy children. Very young children with CF have been reported to have increased arterial stiffness and some decrease in right-left ventricular function. In another study on the subject, it was found that stiffness of the great arteries increased in children with CF; The change in arterial compliancy has been shown to be significant in childhood. The increase in arterial stiffness is associated with systemic inflammation, regardless of blood pressure or diabetes. Hemodynamic changes have been reported in the presence of systemic inflammation in children with CF. Exercise peak workload in children with CF is known to be associated with endothelial dysfunction. It is not known how exercise capacity is affected by endothelial dysfunction and arterial stiffness in CF patients of varying severity. In the literature, there are no studies comparing endothelial function, arterial stiffness and its effect on exercise capacity and pulmonary functions in CF children; this subject is open to research. The aim of this study was to investigate and compare microvascular (peripheral endothelial), macrovascular (arterial stiffness) functions in children with CF and to investigate the relationship of micro and macrovascular functions with exercise capacity and pulmonary functions in children with CF of different obstruction severities.

Eligibility Criteria:
Inclusion Criteria:

* Being clinically stable
* To be cooperated in evaluations to be made
* Forced expiratory volume in the first second (FEV1)\> 40%
* No exacerbation in the past three months
* Regular medication for the past 12 months
* No medication changes for at least three weeks

Exclusion Criteria:

* Cardiovascular disease
* Hypertension
* Diabetes
* Pulmonary hypertension
* Smoking
* Resting oxygen saturation (SpO2) \<92%
* Using vasoactive drugs (nitrates, b-blockers, angiotensin-converting enzyme inhibitors, etc.)
* Using oral steroids
* Undergoing lung surgery
* Being a highly orthopedic, neurological disease
* Injury to the lower extremity such as injury, sprain, or fracture in the past six months
Reminder Messages for Lung Cancer Screening

To test lung cancer screening reminder messages to help adults who 1) 50 to 80 years of age, 2) smoke or have smoked, and 3) do not have history of lung cancer by self-report.

Primary Objectives:

-In this project we will develop, refine, and test reminders for LCS to ensure they are acceptable to patients who have a history of cigarette use.

Eligibility Criteria:
Inclusion Criteria:

* Adults ages 40-80 years
* Currently use combustible tobacco products or used combustible tobacco products in the past
* English or Spanish speaker (based on self-report) Or an adult caregiver/care partner or family member of someone with a history of combustible tobacco product use (may participate in focus groups, cognitive interviews, surveys)

Exclusion Criteria:

• History of lung cancer (based on self-report)
TCI999 in the Efficacy Verification Program of Hair and Body Health Care

To assess TCI999 on hair and body health care


Eligibility Criteria:
Inclusion Criteria:

* Healthy adults aged above 20 years old

Exclusion Criteria:

* Subject who is not willing to participate in this study.
* Patients with diseases of the skin, liver, kidney.
* Subjects who have known cosmetic, drug or food allergies, difficulty in digestive tract absorption or disorder.
* Female who is pregnant or nursing or planning to become pregnant during the course of the study.
* The students taught by the PI.
* Subjects who have wounds on the scalp and subjects who have used drugs to treat the scalp, received hair transplants or other scalp treatments within six months
Neuromuscular Complications of MEK Inhibitors: a French Case Series and a Systematic Review of the Literature

MEK inhibitors (trametinib, cobimetinib, selumetinib or binimetinib) have been used since 2016 to treat metastatic melanoma, by targeting the MAPK pathway Neuromuscular complications (neuropathy, myasthenia or myositis) have been reported in patients treated with MEK inhibitors.

With the growing use of these new oncology therapies, neurologists, oncologists and other clinicians are likely to be increasingly confronted with MEK inhibitor-induced neuropathy, myasthenia or myositis.

Yet, so far, these complications have only been documented in a few single case reports.

Our aim was to characterize the neuromuscular complications associated with MEK inhibitors used either alone or in combination.


Eligibility Criteria:
Inclusion Criteria:

* Patients with neuromuscular complications of MEK inhibitors used alone or in combination
* Age \> 18 years

Exclusion Criteria:

* Refusal of data collection
Effect of Releasing Quadratus Lumborum Muscle on Hip Joint Range of Motion in Asymptomatic Individuals

The purpose of this study are to compare angles of hip joint between before and after releasing quadratus lumborum muscle.

The 1st physical therapist performed the modified Thomas test position. The participant was asked to lie supine over the edge of the couch. The participant hold one knee to the chest tightly while the other knee was bent over the end of the couch. The 2nd physical therapist measured angles of hip and knee using a standard goniometer at baseline. The quadratus lumborum muscle was released. Then the same measurement was repeated.

Eligibility Criteria:
Inclusion Criteria:

1. asymptomatic male and female volunteers
2. age 18-65 years

Exclusion Criteria:

1. having musculoskeletal symptoms (e.g. fibromyalgia, pain at any regions, instability of lower extremities caused by ligamentous injury, injury or trauma to lower extremities), endocrine disease, rheumatoid arthritis
2. taking muscle relaxant or pain killer within 1 day prior to data collection
3. having past history of low back and hip surgery
4. pregnancy
5. having menstruation on data collection day
6. having joint deformities (e.g. knock knee, bow leg)
Itacitinib Combined With INCB024360 and/or Itacitinib Combined With INCB050465 in Advanced Solid Tumors

This is an open-label, Phase 1b, platform study in subjects with advanced or metastatic solid tumors. The study will be divided into 3 parts (Part 1a, Part 1b, and Part 2). Part 1a will evaluate a JAK inhibitor with JAK1 selectivity (Itacitinib) in combination with an IDO1 inhibitor (epacadostat; INCB024360; Group A) and Itacitinib in combination with a PI3K-delta inhibitor (INCB050465; Group B) to determine the MTD or PAD and the recommended Part 1b doses for each combination. Once the recommended dose has been identified for each treatment group in Part 1a, subjects with advanced solid tumors will be enrolled into expansion cohorts based upon prior treatment history with a PD-1 pathway-targeted agent (Part 1b). In Part 2, additional expansion cohorts will be enrolled to further evaluate lower doses of itacitinib and INCB050465 in subjects with select tumor types.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, age 18 years or older.
* Willingness to provide written informed consent for the study.
* Part 1a: Subjects with histologically or cytologically confirmed advanced or metastatic solid tumors that have failed prior standard therapy (including subject refusal or intolerance).
* Part 1b: Subjects with endometrial cancer, gastric cancer, head and neck squamous cell carcinoma, melanoma, microsatellite unstable colorectal cancer, non-small cell lung cancer, pancreatic ductal adenocarcinoma, renal cell carcinoma, triple negative breast cancer, or transitional cell carcinoma of the genitourinary tract that have had disease progression after available therapies for metastatic disease that are known to confer clinical benefit, been intolerant to treatment, or refused standard treatment.
* Part 1b: Must have documented confirmed disease progression on a prior programmed cell death-1 (PD-1) pathway targeted agent or must be PD-1 pathway-targeted treatment naïve.
* Part 2: Subjects with HNSCC, NSCLC, pancreatic ductal adenocarcinoma, salivary gland cancer, and transitional cell carcinoma of the genitourinary tract that have had disease progression after available therapies for advanced or metastatic disease that are known to confer clinical benefit, have been intolerant to treatment, or have refused standard treatment.
* Willingness to undergo a pre-treatment and on-treatment tumor biopsy to obtain the specimen.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Exclusion Criteria:

* Laboratory parameters not within the protocol-defined range.
* Receipt of anticancer medications or investigational drugs within a defined interval before the first administration of study drug.
* Received an immune-suppressive based treatment for any reason within 14 days prior to the first dose of study treatment.
* Has not recovered from toxic effect of prior therapy to \< Grade 1.
* Active or inactive autoimmune process.
* Has received a live vaccine within 30 days of planned start of study therapy.
* Active infection requiring systemic therapy.
L-carnitine vs Placebo for the Treatment of Muscle Cramps After Imatinib in Gastrointestinal Stromal Tumors

we aim to evaluate the efficacy of L-carnitine for the treatment of muscle cramps after imatinib in patients with GIST and apply in the future.

One of the most common side effects of imatinib treatment, muscle cramps occur in about 30% of patients with gastrointestinal stromal tumor (GIST) receiving treatment with imatinib.

It affects the quality of life (QoL) of patients and could also be a factor that affects compliance with treatment. Some studies suggest that L-carnitine may improve muscle cramps associated with cirrhosis or hemodialysis. However, the efficacy of L-carnitine for muscle cramps occurring after imatinib treatment has yet to be reported. Thus, we aim to evaluate the efficacy of L-carnitine for the treatment of muscle cramps after imatinib in patients with GIST and apply in the future.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed GIST patients who are taking imatinib
2. Age 18years or older
3. Patients experienced muscle cramps for more than 8 times (pain of NRS \> 4) or 4 times (pain of NRS \>7) within last 4 weeks
4. Life expectancy \> 6 months
5. ECOG performance status of 0-3

Exclusion Criteria:

1. Patients with renal disease receiving hemodialysis
2. Liver Cirrhosis patients with Child-Pugh class B or C
3. Patients with history of hypersensitivity to drugs including L-carnitine or nutritional supplements
4. Patients with history of spinal cord injury, peripheral vascular disease, or \> Grade 2 peripheral sensory neuropathy
5. Patients with clinically significant electrolyte imbalances such as hypocalcemia, hypokalemia, and hypomagnesaemia
Oral Thalidomide and Tegafur-uracil to Decrease Hepatocellular Carcinoma Recurrence

This single-centered phase II clinical study is to obtain preliminary information on 1-year recurrence-free survival rate, recurrence-free survival and safety profile of thalidomide in combination with tegafur-uracil in hepatocellular carcinoma after hepatectomy and explore biomarkers(VEGF/bFGF) for thalidomide response.

After liver resection to remove the hepatocellular carcinioma completely, the patients with high risk of tumor recurrence will be enrolled into this study. The high risk of tumor recurrence depends on tumor characteristics. The risk factors of tumor characteristics included tumor size \>5 cm in diameter, abscence of encapsulation, vascular invasion and presence of daughter nodules. The patients with high risk of tumor recurrence will have 1 to 3 risk factors. When the patients are enrolled into the study, oral thalidomide in combination with tegafur-uracil will be applied to prevent tumor recurrence. The patients will be fillowed uo erevy 3 mnoths.

Eligibility Criteria:
Inclusion Criteria:

1. stage I-III（TNM: T1-T3） hepatocellular carcinoma
2. previously received curative surgery
3. presence at least one and no more than three of the following risk factors ,

i.Tumor size ≧ 5 cm ii.presence of microscopic or macrovascular venous invasion iii.presence of satellite nodules/addition nodules iv.no capsular formation v.multiple tumors d.performance status of ECOG 0, 1 e.age between 20 and 75 years f.no residual or recurrent tumors detected by computed tomography (CT) or echo within 3-6 weeks after surgery g.written informed consent to participate in the trial

Exclusion Criteria:

1. other malignancy with the exception of curative treated non-melanoma skin cancer or cervical carcinoma in situ prior to the entry of study
2. previously received chemotherapy
3. less than 2 weeks since previous radiotherapy/surgery
4. white blood cell (WBC) less than 3,000/mm3 and absolute neutrophil count (ANC) less than 1,500/mm3, and platelets less than 100,000/mm3
5. serum bilirubin greater than 1.5 times the upper limit of normal range (ULN)
6. alanine aminotransferase (ALT) or aspartate transaminase (AST) greater than 5 times the ULN
7. alkaline phosphatase greater than 5 times the ULN
8. presence of serious concomitant illness which might be aggravated by study medication:uncontrolled infection (active serious infections that are not controlled by antibiotics)
9. hypersensitivity to thalidomide or compounds pregnant or breast feeding women, or women of child-bearing potential unless using two reliable and appropriate contraceptive method
Stress-Induced Inflammation and Reward Processing

Anhedonia, or loss of interest or pleasure, is a key feature of depression and transdiagnostic construct in psychopathology. Both theory and compelling evidence from preclinical models implicates stress-induced inflammation as a key psychobiological pathway to anhedonic behavior; however, this pathway has not been demonstrated in human models. Further, although anhedonia may reflect dysregulation in multiple dimensions of reward, the extent to which stress-induced inflammation alters these dimensions is unclear. The current placebo controlled study used a standardized laboratory stressor task to elicit an inflammatory response in a sample of a healthy young women and evaluate effects of stress-induced inflammation on multiple behavioral indices of reward processing.

In this study we propose to examine the association between psychosocial stress, the stress-induced inflammatory response, and reward processing in a female undergraduate sample. Specifically, we will 1) examine effects of an acute psychosocial stressor on reward processing; 2) evaluate the association between stress-related changes in inflammation and reward processing; and 3) test key vulnerability factors that may moderate the association between stress and reward. To achieve these goals, this study will recruit 60 female undergraduate students to test effects of stress on reward processing in a 3.5 hour laboratory session. Participants will be randomly assigned to either experience a laboratory stressor or a placebo control, and will complete reward tasks 90 minutes post stress/placebo onset, at which point the peripheral inflammatory response to stress reaches its peak. The reward tasks are computerized behavioral tasks that assess three domains of reward processing: reward-learning, reward motivation, and reward sensitivity. Throughout the session, all participants will complete self-report measures of affect and provide blood and saliva samples for evaluation of the psychological and physiological stress response. Within one week prior to the session, participants will attend a 1 hour visit in which they complete baseline reward tasks and self-report questionnaires assessing mood, personality, early life stress, and health behaviors. In total, participants will complete two visits, with a duration of 4.5 hours. This study builds upon prior studies demonstrating immediate effects of acute stress on reward processing, and further tests for delayed effects of acute stress on reward processing. Furthermore, this will be the first study to examine inflammation as a mechanism linking stress to deficits in reward processing. Findings may inform theory of depression etiology and contribute to more specialized treatment that is targeted at specific symptoms of depression.

Eligibility Criteria:
Inclusion Criteria:

* English fluency
* Age 18-28
* Biologically female

Exclusion Criteria:

* Current illness
* Presence or history of major medical conditions
* Current or past diagnosis of alcohol use disorder
* Use of tobacco
* Use of immune-altering medications
* Current pregnancy
Variation in Serum Levels of Metformin in Patients With Reduced Renal Function

Metformin is widely used for treatment of type 2 diabetes mellitus. Side-effects are few and mainly from the gastrointestinal tract. Since metformin is cleared from the blood exclusively via the kidneys reduced renal function is a relative contraindication. We have earlier demonstrated that metformin safely can be used to a lower GFR level of 30 ml/min/1.73. Below that level the risk of lactacidosis, a severe complication, increases.

In the present study we plan to analyse serum levels of metformin repeatedly in patients with moderate renal failure (CKD = GFR of 30-60 ml/min/1.73). Blood samples will be taken as trough values in the morning, week 0, 2, 4, and 8 and at four weeks a blood sample will be taken two hours after intake of the morning dose of metformin. Renal function will be estimated with creatinine and cystatin C at each occasion. The intraindividual variation of metformin will be calculated.

The study rests on a new method for measuring metformin. The technique uses Liquid Chromatography Tandem Mass Spectometry (LCMSMS). Proteins are removed from serum by adding acetonitrile to the sample. After centrifugation a diluted portion of the supernatant is injected into the LCMSMS-system. The total runtime for a sample is 6 minutes.

The study will show if variation in serum levels of metformin measured in the same patient is high or low and thus give us better understanding whether a change i serum level is due to biological variation or to increased retention caused by progressive renal failure.


Eligibility Criteria:
Inclusion Criteria:

* Patients above the age of 18 years with type 2 diabetes mellitus.
* Reduced renal function measured as estimated GFR (below 60 ml/min/1.73).
* Treatment with metformin on going.

Exclusion Criteria:

* Severely reduced GFR (\< 30 ml(min/1.73)
Effect of Glucagon-like Peptide 1 (GLP-1) on Microvascular Myocardial Function in Patients With Type 2 Diabetes.

The purpose of the study is to determine if a GLP-1 agonist improves microvascular perfusion in the heart of patients with type 2 diabetes


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes on monotherapy with metformin or sulfonylurea or combination therapy of metformin and sulfonylurea.
* Age: 25-75 years
* BMI\>25 kg/m2
* HbA1c 6,0-10 %

Exclusion Criteria:

* Current treatment with insulin or Dipeptidyl peptidase IV inhibitor.
* Haemoglobin \< 6.5 mmol/l
* Documented significant stenosis of the left anterior descending artery (LAD) at coronary angiography or CT-angiography or regional dysfunction documented during dipyridamol stress-echocardiography. If stress test at baseline shows significant stenosis the patient will be excluded from the study.
* Allergy towards victoza ® (liraglutide ), Dipyridamol, Nitroglycerin or rescue medicine: Theophyllin
* Pregnancy
* Severe asthma
* Active cancer
* Severe co-morbidity with limited life-expectancy
* Estimated glomerular filtration rate (eGFR) \<60 (measured at baseline)
* Severe hepatic co-morbidity
* Chronic alcohol abuse
* Heart failure with a left ventricular ejection fraction \</= 45%
* Atrial fibrillation
* Chronic or previous acute pancreatitis
* Inflammatory bowel disease.