cyrilzakka/clinical-trials huggingface dataset:
Urinary Congophilia As an Indicator of Activity of Lupus Nephritis

Evaluation of the impact of SLE on urinary levels of congophilia and their relationship to renal histopathology and activity of lupus nephritis (LN)

Systemic lupus erythematosus (SLE) is an inflammatory autoimmune disease that can affect all body organs. The reported lifetime incidence of lupus nephritis (LN) in SLE patients is 20%- 60% and it is histologically evident in most SLE patients, even without clinical manifestations of kidney disease .

Lupus nephritis is associated with higher mortality , as within 5 years of diagnosis, between 10 and 30 percent of these people develop end-stage renal disease . Early detection and treatment of lupus nephritis can significantly improve renal outcomes and decrease overall mortality .

Endoplasmic reticulum (ER) stress proteins, which act as protein quality control factors in the secretory pathway in the cell are induced by ER stress in inflammatory lesions, and also participate in autoimmunity and inflammation processes, ER stress proteins are expressed not only in the ER but also occasionally at the cell surface that plays pathophysiological roles in autoimmune and inflammatory diseases as pro- or anti-inflammatory factors, Protein folding is easily impaired (misfolding) by different cytotoxic stresses as inflammation or hypoxia , that may contribute to disease pathogenesis by either reducing the biological activity of the protein or due to toxicity by the misfolded proteins, The detection of the abnormally misfolded proteins using the Congo red stain is referred to as congophilia, Urinary congophilia was assessed by Congo Red Dot Blot (CRDB) Assay Congo red is a synthetic diazo dye with specific affinity for β-sheets of amyloid fibrils of misfolded proteins, In addition to the simplicity of congophilia based dot blot technique, the non-invasiveness of the method is useful in adapting the CRDB assay for self-collected urine samples.

One previous study in pregnant females with lupus nephritis said that urinary congophilia has a diagnostic value in patients with lupus nephritis and can be used as a reliable marker of disease activity as the presence of urinary congophilia biomarker is related to disease activity rather than pregnancy.

Eligibility Criteria:
Inclusion Criteria:

- Adult patients ≥ 18 years old that were diagnosed with SLE according to EULAR/ACR classification criteria 2019 for SLE, and lupus nephritis based on renal biopsy or active urinary sediment (proteinuria or hematuria )

Exclusion Criteria:

* Any patient has evidence of nephritis that may cause proteinuria as diabetes mellitus and any other causes of glomerulonephritis other than lupus nephritis
* pregnant females with lupus nephritis and hypertensive disorders
WRx Distal Radius Wrist Fracture Study

This research project is a multi-year proposal, with the goals of answering and evaluating the following:

1. Does an intramedullary locking device applied in an extra-articular distal radius fracture improve post operative pain, diminish hospitalization, improve early return to activity and function compared to a volar locked plate?
2. Does an intramedullary locking device applied in an extra-articular distal radius fracture improve patient related outcome measures compared to a volar locked plate?


Eligibility Criteria:
Inclusion Criteria

The following criteria must be met to be enrolled:

1. Have a closed extra-articular distal radius fracture or a minimally displaced intra-articular component
2. Have a fracture classified as an AO Type A or C1 with or without an ulnar styloid fracture
3. Be a male or non-pregnant female at least 18 years of age.
4. Understand the requirements of the study and able to provide a written informed consent and comply with the study protocol
5. Have the ability to understand and provide written authorization for use and disclosure of personal health information
6. Have a fracture that can be closed reduced to acceptable radiographic parameters (minimum of neutral volar tilt, greater than or equal to 15 degrees of radial inclination and at least 10 mm of radial height as compared to the opposite side)

Exclusion Criteria

Subjects are excluded if:

1. Have any of the following conditions

   1. Concomitant contralateral or ipsilateral upper extremity fractures
   2. Ipsilateral ulna (excluding styloid) fracture
   3. Open, multifragmentary fracture
   4. Unstable distal radioulnar joint after fracture fixation
   5. Artery or Nerve injury secondary to fracture
2. Previous ipsilateral distal radius fracture in the 2 years prior to enrollment with deformity
3. Currently on chemotherapy or radiation therapy
4. History of a metabolic disorder affecting the skeletal system other than osteoarthritis or osteoporosis
5. History of uncontrolled diabetes
6. History of active rheumatologic disease with deformity
7. History of chronic pain issues, psychiatric disorder which precludes reliable follow-up
8. Unable to provide consent for the study
9. Unable to make the follow-up appointments required of the study
Effects of Three Different Mouth Rinses on Dental Plaque in Children

Dental plaque is a major problem in the field of oral and dental health and its prevention is more important to avoid dental caries and gingival diseases. Mouth washes are very useful in the reduction of microbial plaque and gingival inflammation. Sodium fluoride mouth wash is one of the ways that prevent dental plaque. Recently, using herbal products are efficient in decreasing dental plaque. Pomegranate peels and Guava leaves extracts are an essential medicinal plant with various pharmacological properties.

Aim of study: To evaluate and compare the efficiency of different mouth rinses (sodium fluoride mouth rinse, guava leaves aqueous extract and pomegranate aqueous extract) on dental plaque in children, clinically by measuring gingival and plaque indices scores and microbiologically by measuring of streptococcus mutans and lactobacillus.

Materials and methods: forty apparently healthy and cooperative children were selected from the Outpatient Dental Clinic of Pediatric dentistry Department, Faculty of Dentistry, Suez Canal University. Children were randomly divided into three groups as follows:

Group (I):10 children will rinse with sodium fluoride, Group (II): 10 children will rinse with guava leaves aqueous extract and Group (III):10 children will rinse with pomegranate peels aqueous extract. Group (IV):10 children will rinse with water (control group). Instructions for oral hygiene and using mouth wash will be demonstrated for every child. Clinical and microbiological examinations will be done firstly at day one before using any type of examined mouthwashes (0-base line), then clinical and microbiological follow up will be done after 7 and 15 days of using different mouthwash for each group.


Eligibility Criteria:
Inclusion Criteria:

1. Children are apparently healthy.
2. Their age's ranges from 6-12 years {mixed dentition}, First permanent molars were fully erupted.
3. Children are not taking antibiotics, steroids and inflammatory therapy for two weeks before study or during this study.
4. Children are caries free at time of the study.
5. Children with no regular use of chewing xylitol gum.
6. Children without orthodontic appliance.
7. Children are not using fluoride tooth paste or any topical fluoride application at time of study.
8. Children who have dental plaque.

Exclusion Criteria:

1. Uncooperative children.
2. Children with history of allergy to dental products or their products
3. Parents refusal.
Surufatinib as Neoadjuvant Treatment for Locally Advanced or Metastatic Differentiated Thyroid Cancer

Locally advanced thyroid cancer has a wide range of surgery, large trauma and high local recurrence rate. It is one of the main causes of death in patients with thyroid cancer. Therefore, more effective treatments are urgently needed. This study is designed to evaluate the efficacy and safety of the Surufatinib for Locally Advanced Thyroid Cancer.


Eligibility Criteria:
Inclusion Criteria:

* Locally advanced or metastatic thyroid cancer confirmed by histology or cytology, including papillary thyroid carcinoma, follicular thyroid carcinoma, poorly differentiated thyroid cancer, particularly differentiated thyroid cancer. Locally advanced stage refers to: 1) Primary tumor with invasion or adhesion of organs and structures, such as recurrent laryngeal nerve, esophagus, trachea, larynx, encirclement of neck large vessels, mediastinal vessels, extensive invasion of skin, subcutaneous soft tissue or neck muscles; 2). AJCC T4 Stage; 3). Difficult to achieve R0/R1 resection during preoperative assessment;
* Age 14-75 years;
* At least one measurable lesion (RECIST 1.1);
* Eastern Cooperative Oncology Group (ECOG) score 0-1;
* Expected survival time ≥ 12 weeks;
* The main organ functions meet the following criteria: Absolute neutrophil value (ANC) ≥ 1.5 × 109 / L; Platelet (PLT) ≥80 × 109 / L; Hemoglobin (HB) ≥9g / dL; White blood cell count\> 1.5 × 109 / L; Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal value (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 ULN, if with liver metastases, ALT and AST ≤ 5 ULN; Serum creatinine (Cr) ≤ 1.5 ULN or creatinine clearance (CCr) ≥ 50ml / min;
* Subjects of potential fertility are required to use at least one medically approved contraceptive method (such as an intrauterine device, contraceptive pill, or condom) during the study treatment and for 180 days after the end of the study treatment; The serum HCG test must be negative before the first medication.

Exclusion Criteria:

* Prior treatment with anti-angiogenic small molecule targeted drugs;
* Received other anti-tumor therapy (including but not limited to chemotherapy, radiotherapy, etc.) within 4 weeks prior to treatment, except for TSH suppression treatment;
* Allergy to the study drug ;
* Have a history of serious cardiovascular and cerebrovascular diseases;
* Patients whose imaging showed that the tumor had invaded the important blood vessels or the researchers judged that the tumor was likely to invade important blood vessels during the subsequent study period and caused fatal bleeding;
* Patients with hypertension that cannot be well controlled by antihypertensive medication (systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥100 mmHg);
* The patient has had other malignant tumors within 5 years (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix);
* The investigator considered that the subject was not suitable to participate in the study due to any clinical or laboratory abnormalities or other reasons.
Investigation of Clinical Relevance of β-D-Glucan Tests in Patients With Invasive Fungal Infection (IFI)

Invasive fungal infection (IFI) is a disease usually occurred in the patients with compromised immune condition, such as acute leukemia, allogeneic stem cell transplantation or long term immune suppression treatment with the incidence increasing over last decades. Given the introduction of numerous anti-fungal agents and great advance has been made in recent years, IFI is still a dangerous disease with high mortality.

Early diagnosis of IFI is still a problem challenging the physicians. Serum tests of β-D-Glucan are introduced to the diagnosis of IFI, which have the advantage of easy application. However, the value of this test in the monitoring of antifungal treatment remains unclear.

The investigators perform this study to evaluate the correlation of the serum test results of β-D-Glucan test with the treatment response during the anti-fungal treatment, and hope to see that the results of serial serum tests are good predictive markers for treatment response.

This is a single center, open-label study. The duration of the study will be 2 years. The number of targeted subjects will be 50 (in 2 years). We estimate that on average, the treatment duration is 4-8 weeks. Serum Glucan levels will be measured 2 times per week until the recovery of the infection or treatment end.

Eligibility Criteria:
Inclusion Criteria:

Patients with proven or probable IFI and immunocompromised because of hematopoietic-cell transplantation (HSCT) or chemotherapy, and have positive results for serum Glucan tests will be included in the study.

Patients must satisfy all the following criteria before entering the study :

1. Episode of proven or probable IFI, diagnosed according to the EORTC/MSG definitions;
2. Immunocompromised because of HSCT or chemotherapy for malignant hematopathy;
3. ≥ 2 consecutive positive serum glucan level, using a threshold for positivity of ≥ 60 ng/L, at the start of antifungal therapy.

Exclusion Criteria:

If the fungal infection of the patient is excluded or confirmed to be a specific pathogen other than fungi before the enrollment/during the study period, he or she will be excluded/withdrew from the study.
Safety and PK Study of MP-424 to Treat Chronic Hepatitis C

The purpose of this study is to assess the safety, pharmacokinetics and HCV(Hepatitis C virus) RNA (Ribonucleic Acid) kinetics after administration of MP-424 to patients with chronic hepatitis C.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with genotype 1b chronic hepatitis C
* Patients naive to the concomitant medications with interferon

Exclusion Criteria:

* Patients diagnosed with decompensated cirrhosis
* Patients diagnosed with positive HBs(Hepatitis B virus surface) antigen in the test
Acupressure and Comfort at Childbirth

Aims: Non-pharmacological methods employed for management labor pain also help pregnant women to cope with labor pain and increase their childbirth comfort. The aim of this study is to determine the effect of cold and hot acupressure applications, applied to the acupressure point LI4 of primiparous women during labor, on their childbirth comfort.

Methods: This study was designed a randomized controlled experimental study. The sample consisted of 129 healthy pregnant women including 44 pregnant women in the hot acupressure group, 44 pregnant women in the cold acupressure group, and 41 pregnant women in the control group. The "Personal Information Form", the "Labor Monitoring Form", the "Visual Analog Scale", and the "Childbirth Comfort Questionnaire" were all used to gather the data.


Eligibility Criteria:
Inclusion Criteria:

* Being a primipara
* Having intact membranes
* No skin diseases (such as urticaria...),
* No use of narcotic drugs
* Having a term pregnancy
* Having a single fetus at vertex position
* Planning to have vaginal delivery
* Having contractions and ongoing regular augmentation
* Having recent augmentation starting periods
* Being in the latent phase (0-3 cm dilatation)
* Having no history of high-risk pregnancy
* Not using analgesic drugs to reduce pain during delivery
* Having no systemic and neurologic diseases
* Having no contraction anomaly (hypotonic or hypertonic contractions)

Exclusion Criteria:

• Having any of the above criteria
Illness Expectations in COPD

This study investigates the impact of expectations on individuals with Chronic Obstructive Pulmonary Disease (COPD) and aims to develop and validate a novel tool to assess these expectations. By understanding the role of expectations, healthcare providers can better tailor interventions and support for COPD patients, ultimately improving their quality of life and treatment outcomes.

This research, carried out at the specialized cardiorespiratory rehabilitation unit of the Don Gnocchi Foundation in Milan, delves into the influence of expectations on individuals living with Chronic Obstructive Pulmonary Disease (COPD). The primary objective is to craft and validate a fresh assessment tool to gauge these expectations. Moreover, the questionnaire is reintroduced to patients after a month, during which additional data, as detailed in the corresponding section, are gathered.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of COPD confirmed by spirometry
* Adults
* Italian speakers
* Ability to complete the required tests
* Informed consent from the patient to participate in the study

Exclusion Criteria:

* Non-Italian speakers
* Psychiatric comorbidities
* Cognitive impairment
Tofacitinib Registry of Patients With Ulcerative Colitis in Germany

This registry on Tofacitinib and biologics (anti-integrin/anti-TNF) in the treatment of ulcerative colitis (UC) patients in Germany will extend the prospective documentation of safety issues and efficacy in induction and maintenance therapy of Tofacitinib (Xeljanz®) in addition to other biologics used in Germany with a particular interest in predictors of long-term responses and favorable disease outcome or to predict severe side effects caused by therapy with Januskinase(JAK)- inhibitors/biologics.

This is an Investigator-initiated non-randomized, non-interventional observational prospective long- term research (IIR) as part of the normal treatment of UC patients for the safety and efficacy of Tofacitinib / biologic therapies. As of 01st July 2019, UC patients who have been provided Tofacitinib / biologics for UC according the respective label by the treating physician may be prospectively included in an online database by the participating study centers by 31st March 2021.

An interim analysis is planned at the end of patients ́ recruitment with respect of the induction phase (week 16) for October 2021 with a first publication of the data in a peer-reviewed journal (e.g., JCC, GUT, UEG Journal).

Up to 480 patients (including about 360 UC patients with Tofacitinib and about 120 UC patients with biologics) will be included in the online documentation. A specification to the study centers regarding the group inclusion (patients treated with Tofacitinib (group 1) or a biologics (group 2)) will not be made; this means, each study center can include patients in both groups.

The CED Service GmbH assume that approximately 20-30% of Tofacitinib patients will be biologic-naïve UC patients, many of whom will represent early disease patients (\< 2 years after first diagnosis).

Eligibility Criteria:
Inclusion Criteria:

* Patients with moderate to severe Ulcerative Colitis aged 18-80 years at enrollment
* Written informed consent is given

Exclusion Criteria:

* Malignant disease in history (except for non-melanoma skin cancer)
* Any contraindication according to the SmPC of the respective medication
Comparison of the Impact of Diet vs Thiazide in BMD in Children With Idiopathic Hypercalciuria

The investigator's objective is to compare and evaluate the impact of nutritional treatment vs. pharmacological treatment (hydrochlorothiazide) in bone mineral density in children with idiopathic hypercalciuria.

A randomized, open-label, one-year follow-up study will be conducted in children aged 5 to 21 years with a confirmed diagnosis of idiopathic hypercalciuria or lithiasis, excluding those patients with secondary hypercalciuria (primary hyperoxaluria, treatment with vitamin D, Bartter syndrome, primary hyperparathyroidism), previous kidney transplantation. The impact of diet (hyposodic, calcium intake according to DIR for age, normal protein intake and high water intake) will be evaluated vs. the pharmacological treatment (hydrochlorothiazide) on bone mineral density.

A randomized, open-label clinical trial will be conducted with a one-year follow-up. For which basal measurement of calciuria, citraturia, serum creatinine, serum and urinary electrolytes, parathyroid hormone, vitamin D levels and renal ultrasound, as well as dietary intake (protein, energy, salt and water). The dietary intake per day of food and pharmacological treatment will be evaluated quarterly, body composition (anthropometry) and serum and urinary electrolyte levels will be measured; Bone constitution (DXA, quantitative bone ultrasound), IL-1 (as inflammatory markers) and vitamin D will be evaluated every six months.

Participants will be blinded to the pharmacological treatment they will receive. The randomization of the participants will be done through the page www.randomization.com. The randomization was performed by blocks, where blocks of 6 members each were made i. Group 1: only recommendations of water intake and reduction of salt intake and hydrochlorothiazide will be given (the dose will be assigned according to weight and sex by a pediatric nephrologist, dose of 0.5-1.5mg / kg / day, starting with the dose 1 mg / kg). Hydrochlorothiazide will be provided to the patient.

ii. Group 2: placebo capsules and a strict diet plan will be given. The placebo will look similar to that of hydrochlorothiazide and will be prepared in the Nephrology Research Laboratory by Biol. Ana María Hernández Sánchez and Quim Lourdes Ortiz. The feeding plan will be appropriate for the patient, it will consist of:

1. 40 ml / Kg / day of water
2. Protein according to age and sex
3. Recommendations for low sodium intake
4. Calcium according to age and sex (minimum 800mg)

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of idiopathic hypercalciuria
* Man or women
* 5 to 21 years

Exclusion Criteria:

* Clinical diagnosis of secondary hypercalciuria (primary hyperoxaluria, treatment with vitamin D, Bartter syndrome, primary hyperparathyroidism)
* Previous kidney transplant
* Clinical diagnosis of kidney disease.
* Vitamin D intake (more than 800 mg/day)
Testing a Brief and Low Intensity Self-compassion Intervention

The investigators' recent feasibility trial of a self-compassion and active control intervention showed that the self-compassion intervention was promising in reducing state body shame during a 40-minute intervention session. There were three time points where the reduction in the body shame level was significant, indicating three active components in the intervention that led to significant reduction in state body shame. It is unclear if a shorter self-compassion intervention based on only the active components would be as effective as the longer intervention at reducing state body shame. Such a short intervention then could be used as an in-session change method (15-20 mins) as part of a larger package, or as a homework exercise.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Self-identified women
* Be able to use a computer and have an Internet connection

Exclusion Criteria:

* Insufficient knowledge of English
* Learning disability or psychiatric illness requiring secondary care intervention
* Male
* Under 18 years old
* No access to a tablet or computer with an internet connection
* Body mass index below 18.5
Evaluation of Correct PEP Use With the Time

Healthy subjects will be trained to used correctly a positive expiratory pressure device. The aim of the study is to evaluate te reproductibility of the correct used of the device after training


Eligibility Criteria:
Inclusion Criteria:

* No lung disease
* Older than 18 years

Exclusion Criteria:

* Psychological disorder