cyrilzakka/clinical-trials huggingface dataset:
Effect of TruNatomy and HyFlex EDM Instrumentation on Postoperative Pain

The aim of the present study is to clinically compare the incidence of postoperative pain after root canal preparation using TruNatomy system and HyFlex Electrical Discharge Machined (EDM) rotary system in asymptomatic necrotic mandibular molars.

Up till now, there are no clinical studies on the effect of instrumentation using TruNatomy files on post-operative pain. Furthermore, these newly introduced files can provide more affordable means for instrumentation. Therefore, the purpose of this study is to clinically compare the effect of using TruNatomy files and HyFlex EDM files on post-operative pain.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 25 - 45 years old.
2. Males or Females.
3. Mandibular molar teeth with:

   * No pain.
   * No response to pulp testing.
   * Radiographic appearance with or without a periapical radiolucency.

Exclusion Criteria:

1. Patients with pre-operative pain.
2. Patients having significant systemic disorders.
3. Patients who are allergic to non-steroidal anti-inflammatory drugs.
4. Patients with two or more adjacent teeth requiring root canal therapy.
5. Teeth that have:

   * Vital pulp tissues.
   * Association with swelling or fistulous tract.
   * Acute or chronic peri-apical abscess.
   * Greater than grade I mobility.
   * Pocket depth greater than 5mm.
   * No possible restorability.
   * Previous endodontic treatment.
Myocardial Injury and Quality of Life After COVID-19

In this observational study follow-up and dynamic observation will be conducted on the participants recovered from pneumonia caused by COVID-19. The main goal is an early diagnosis and detection of myocardial (heart) injury and quality of life in participants recovered from COVID-19 and follow-up in selected participants with present signs of myocarditis and/or myocardial fibrosis.

The main goal of this observational non-interventional study is the evaluation of prevalence of myocardial injury (heart injury) of the participants recovered from the novel coronavirus infectious disease (COVID-19). Participants with signs of myocarditis (pericarditis) and/or myocardial fibrosis, and with a threat of heart failure development and other outcomes are selected into this study. In this cohort the percentage of participants having myocardial injury based on the level of high-sensitivity troponin, echocardiography (decreased Left Ventricle Ejection Fraction, abnormalities of wall motion, Right Ventricle dysfunction, increased size of heart chambers above referential values, presence of pericardial effusion), cardiac MRI with contrast enhancement (presence of edema on T2-weighted images, presence of early and late gadolinium enhancement phenomenon, local motion abnormalities, increased size of heart chambers above referential values, presence of pericardial effusion). At 6 months of the dynamic follow-up, MRI with contrast enhancement will be repeated in the participants with established myocardial injury at inclusion to assess the percentage of the participants having ongoing myocardial injury.

The secondary goal of the study is evaluation of quality of life of the patients recovered from the novel coronavirus infectious disease (COVID-19) by the means of EQ-5D and/or DASI questionnaire using the descriptive system of 5 components of quality of life related to the wellbeing, and visual analogue scale.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients of age above 18 years with diagnosed SARS-CoV-2 infection based on the PCR (polymerase chain reaction) and/or quantitative tests of IgM and IgG antibodies in serum;
* Pneumonia development confirmed by chest computed tomography;
* Negative PCR test for SARS-CoV-2 at the time of inclusion into the study;
* Stable patient state allowing outpatient follow-up;
* Signed informed consent.

Exclusion Criteria:

* Absence of convincing data confirming SARS-CoV-2 infection of a participant at the time of inclusion;
* Absence of medical records regarding previous treatment of COVID-19;
* Low compliance and unwillingness to undergo defined examinations;
* Absence of informed consent.
Study Of Perennial Allergic Rhinitis In Pediatrics

To verify of cetirizine dry syrup to ketotifen dry syrup in the change of total nasal symptom score (TNSS) over the total treatment period from the score of the baseline assessment period


Eligibility Criteria:
Inclusion Criteria:

* Children with perennial allergic rhinitis.
* Giving informed consent.
* Children with a positive response to specific IgE antibody test.
* Children assessed as positive in the nasal eosinophil count.
* Children whose severity score of nasal symptom is 4 or higher.

Exclusion criteria:

* have spastic disease such as epilepsy
* have a history of drug hypersensitivity
* are pregnant, lactating or possibly pregnant female Children
* are sensitive to pollen as a duplicate allergen and whose treatment periods are thought in the pollen dispersion periods
* have vasomotor rhinitis and eosinophilic rhinitis
* have asthma that requires the treatment with corticosteroid
* have inappropriate complication of nasal disorder that may influence on the evaluation of the study drugs
* have complicated with atopic dermatitis or urticaria that requires the treatment with antihistamine preparation
* have started specific desensitization treatment or nonspecific modulation treatment but who have not reached the maintenance level of treatment
* have received surgical treatment for reduction and modulation of nasal mucosa
* redintegration therapy of nasal cavity to improve the degree of nasal airway
* surgical operation to improve rhinorrhea.
Single vs. Group CAPA-IVM Culture of Cumulus-oocyte Complexes

Oocyte in vitro maturation (IVM) is a minimal-stimulation ART with reduced hormone-related side effects and risks for the patients. However, the approach is not widely used because of an efficiency gap compared to conventional ART. In order to further optimize and adapt the CAPA-IVM system in the IVM clinic, this pilot study aims to check the feasibility of applying a single COC CAPA-IVM strategy versus the group COC culture CAPA-IVM

Oocyte in vitro maturation (IVM) is a minimal-stimulation ART with reduced hormone-related side effects and risks for the patients. However, the approach is not widely used because of an efficiency gap compared to conventional ART.

Oocytes retrieved for IVM procedures derive from a heterogeneous pool with variable cellular and molecular characteristics that indicate its immature status. Thus, in vitro systems that permit and enhance acquisition and synchronization of meiotic competence (ability to resume meiosis in response to an ovulatory stimulus) and developmental competence (ability to be fertilized and support early embryo development) before the meiotic trigger are crucial for the optimization of human IVM systems.

A novel two-step IVM culture system (named CAPA-IVM) involving a pre-maturation culture with C-type natriuretic peptide (CNP) and a maturation step in presence of Amphiregulin (AREG), both more physiological compounds improving oocyte competence, have been introduced in previous clinical studies. So far these pilot studies proved to increase the rates of oocyte maturation, good quality embryos on day 3, good quality blastocyst, and as a result a higher embryo yield. CAPA-IVM blastocysts have shown similar rates of methylation and gene expression at gDMRs compared to COS embryos; and the expression of ma-jor epigenetic regulators was similar between both groups. Furthermore, an improvement in pregnancy rates strengthens the clinical relevance of the use of CAPA-IVM strategy.

In order to further optimize and adapt the CAPA-IVM system in the IVM clinic, this pilot study aims to check the feasibility of applying a single COC CAPA-IVM strategy versus the group COC culture CAPA-IVM. A single COC culture would permit to perform a non-invasive molecular analysis per matured oocyte, in order to identify quality genes ex-pressed in cumulus cells post-IVM (cumulus biomarkers), which could be subsequently used to identify the embryo(s) with highest potential of implantation.

Eligibility Criteria:
Inclusion Criteria:

* Having polycystic ovarian morphology: at least 25 follicles (2-9 mm) throughout the whole ovary and/or increased ovarian volume (\>10ml) (it is sufficient that 1 ovary fits these criteria)
* No major uterine or ovarian abnormalities
* Having at least 15 follicles on the OPU day
* Patients consent to participate in the study

Exclusion Criteria:

* High (\>grade 2) grade endometriosis
* Cases with extremely poor sperm (serve OAT: density \<1 million, mobility \<10% and sperm from testicular surgery)
Evaluate Efficacy and Safety of Saxagliptin in Adult Patients With Type 2 Diabetes Inadequate Glycemic Control

Saxagliptin is a new investigational medication being developed for treatment of type 2 diabetes. This study is designed to evaluate the efficacy and safety in adult patients with inadequate glycaemic control with diet and exercise.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with Type 2 diabetes
* Patients should be drug naïve ie, not received medical treatment for diabetes,
* HbA1c ≥ 7.2% and ≤10.0% (at enrolment), HbA1c ≥ 7.0% and ≤10.0% (at randomization)

Exclusion Criteria:

* Insulin therapy within one year of enrolment (with the exception of insulin therapy during a hospitalization or use in gestational diabetes),
* Type 1 diabetes,history of ketoacidosis or hyperosmolar non-ketonic koma
Ex Vivo Study of the Mechanism of Action of Active Ingredients on the Intestinal Microbiota

To design and understand the mechanism of action of different combinations of nutraceuticals coupling bacteria, fibers and polyphenols, which can act on the 4 pillars simultaneously via an innovative ex-vivo model approach coupled with functional and quantitative metagenomics.

The objective of the study is to collect fresh stools from 4 healthy volunteers, in order to study the mechanism of action of probiotic strains, polyphenols and fibers, alone or in combinations. These fresh stools will be cultured in vitro in fermenters, and the samples taken at different culture times will be analyzed in terms of microbial composition (shotgun metagenomic analysis) and their cellular activity (functional metagenomic analysis).

Eligibility Criteria:
Inclusion Criteria:

* Person with a low fiber diet (\<17g / day).

Exclusion Criteria:

* Taking antibiotics and / or transit modulators in the 3 months preceding the sample;
* Colonoscopy in the last 3 months;
* Person under legal protection measure (curators, tutors, etc.).
Culturally Adapted Cognitive Behavioral Therapy Based Self Help Intervention for Mental Health of Caregivers of Individuals with Substance Use: a Randomized Controlled Trial

The primary purpose of this study is to investigate whether Cognitive Behavioral Therapy based Self- Help Intervention can significantly reduce emotional problems as well as improve the mental well being and quality of life among the caregivers of individuals with substance use. The study aims to contribute to the existing literature by providing evidence on the efficacy of the above mentioned therapy. This can be helpful in improving clinical practices and treatment outcomes.

The current quantitative study comprises of two phases. Pilot study for translation and validation of scales were done as a preliminary step. The first phase was a cross-sectional survey to screen out potential caregivers of substance users, with depression, anxiety and stress, higher than the normal level. A randomized controlled trial (RCT) was done in the second phase, where caregivers of substance users who had higher level of psychological distress, were categorized into two groups; control group and intervention group through randomization. Cognitive Behavioral Therapy based intervention (Self- Help Manuel named, "Khushi aur Khatoon") was provided to the intervention group in 4-6 individual and face to face sessions. Control group did not receive therapy ( on request of some of the members of control group, therapy was provided after the completion of the study). Pre and post- assessment of the study variables were done for both control and intervention groups. Difference between pre and post assessment was compared to investigate the effectiveness of Cognitive Behavioral Therapy based intervention ("Khushi aur Khatoon") among caregivers of substance users.

Eligibility Criteria:
Inclusion Criteria:

* Individuals aged 18 and above.
* Those who will have burden and distress above the normal levels on respective scales during baseline assessment.
* Capable of providing written informed consent.
* Residing within the catchment areas of the participating rehabilitation center.

Exclusion Criteria:

* Individuals unable to provide consent due to severe mental or physical illness.
* Individuals not capable of reading and comprehending Urdu versions of the intervention manual and scales.
* Unlikely to be accessible for outcome assessments due to temporary residence.
Adding Adjuvant Cisplatin and Gemicitabine Versus Capecitabine in Triple-negative Breast Cancer Patients in Non pCR After Neoadjuvant Standard Chemotherapy

In our study; investigator aim To show efficacy and toxicity of Adjuvant cisplatin and gemcitabine in triple-negative breast cancer patients with non pathologically complete response after neoadjuvant chemotherapy To compare outcome of adjuvant cisplatin and gemcitabine versus capecitabine

Patients with operable, primary invasive non inflammatory early TNBC of stage I-IIIB and pathologically verified residual cancer cells (no pathological complete response) after neoadjuvant chemotherapy then underwent adjuvant treatment with gemcitabine plus cisplatin Patients will be followed up every 3 month in first year then every 6 month in the second year then followed up yearly Study will be conducted at Assiut University Hospital with sample size calculation BRACA will be done

Eligibility Criteria:
Inclusion Criteria:

* Age: 20 years and older.
* Patients with no clinical/radiologic distant metastasis.
* Tumor type: Invasive ductal carcinoma or invaive lobular carcinoma.
* Tumor subtype: triple negative
* patients had operable, primary invasive, noninflammatory early stage I-IIIB TNBC (ER and PR \<1%, HER2 score: 0 or 1)
* Patients with a good performance status (0/1)
* Patients with adequate hematological, cardiac, renal, and hepatic function

Exclusion Criteria:

* Patients who achieve pathologic complete response after neoadjuvant chemotherapy
* inflammatory breast cancer
* Breast cancer patients with distant metastasis
* Patient with hormonal receptor positive /HER2 +ve
Evaluation of Different Psychiatric Symptoms in Patients With Thyroid Dysfunction

1. Evaluate psychiatric symptoms in patients with thyroid dysfunction.
2. Investigate effect of treatment on psychiatric symptoms after 2 months.

Thyroid dysfunction is associated with psychiatric symptoms in addition to endocrinal manifestations.

The study aims to evaluate the prevalence of psychiatric symptoms in patients with thyroid dysfunction and investigate the response after thyroid treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients newly diagnosed as having thyroid dysfunction.

Exclusion Criteria:

* Patients with other endocrinological disorders or significant medical or neurological diseases.
* Alcohol or substance abuse
Sit-to-stand Trainer in Patients After Lower Limb Amputation

The study will include rehabilitation inpatients after unilateral lower limb amputation who are candidates for walking with a prosthesis. Those in the experimental group will receive training using a sit-to-stand trainer device in addition to standard training of standing-up with the help of a physiotherapist. Those in the control group will only receive the standard training. The effects of the rehabilitation programme will be assessed using the 30-Second Chair Stand Test before the start of the training and after 10 days of training. For the first five patients from each group who will be able to stand up with the use of hands, detailed kinesiological analysis of standing-up pattern will be performed.


Eligibility Criteria:
Inclusion Criteria:

* unilateral lower-limb amputation
* candidate for walking with a prosthesis
* Montreal Cognitive Assessment (MoCA) test score 26 or more

Exclusion Criteria:

* associated neurological or orthopaedic disease
* amputation caused by cancer or injury
* BMI below 18.5 or above 30
Study of TCM Syndrome of Hepatocellular Carcinoma and Colorectal Cancer Based on System Science

Traditional Chinese medicine (TCM) syndrome is a core foundation of disease knowledge, clinical diagnosis and treatment and curative effect evaluation in TCM. "Same TCM Syndrome for Different Diseases" and "Same Treatment for Different Diseases" is one of the characteristics of TCM syndrome differentiation and treatment.

This study is the "TCM disease syndrome combination" research baced on principles and methods of system biology, which is through acquisition of primary hepatocellular carcinoma (HCC) and colorectal cancer patients with TCM syndrome information, detection of clinical indicators and genomic, proteomic, and metabolites changes, analyzing the correlation between TCM syndromes and biological information, and revealing its biological material characteristics and the molecular mechanisms of "Same TCM Syndrome for Different Diseases";Developing and implementing the program of TCM syndrome differentiation and treatment for HCC and colorectal cancer to evaluate the efficacy of TCM syndrome based-treatment of HCC and colorectal cancer with TCM syndrom scores, clinical and systems biological indicators, quality of life and survival rate, and to revealing the mechanism of the "Same Treatment for Different Diseases".

Traditional Chinese medicine (TCM) syndrome is a core foundation of disease knowledge, clinical diagnosis and treatment and curative effect evaluation in TCM. "Same TCM Syndrome for Different Diseases" and "Same Treatment for Different Diseases" is one of the characteristics of TCM syndrome differentiation and treatment.

In this study, the investigators adopted the transcriptome analysis, proteome analysis and metabolic diversity analysis of the patients with different syndromes of liver cancer and colorectal cancer, and integrate omics information, combining macro and micro methods to screen biomarkers of syndromes

Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of primary liver cancer (HCC) and colorectal cancer after surgery.
2. Liver cancer and colorectal cancer liver and kidney yin deficiency and spleen qi deficiency syndrome diagnosis standard : Yin deficiency of liver and kidney and spleen qi deficiency syndrome see hypochondriac pain, waist and knee Limp, fever, night sweats, dry mouth and throat, fatigue, anorexia, abdominal distension after eating more, red or pale tongue, less moss or Light peel, pulse fine.

Exclusion Criteria:

(1) there is a serious heart, kidney, and other diseases of the hematopoietic system effect of drug evaluation factors; (2)Mental disorders (3)Digestive tract obstruction; (4) poor compliance.
Dose Escalation Study of LEE011 in Combination With Buparlisib and Letrozole in HR+, HER2-negative Post-menopausal Women With Advanced Breast Cancer.

This is a multi-center, open-label, non-randomized, phase I study


Eligibility Criteria:
Inclusion Criteria:

1. Women with advanced (recurrent or metastatic) breast cancer who received no prior therapy for advanced disease.
2. Patient is postmenopausal.
3. Patient may have received ≤ 2 lines of chemotherapy for metastatic or recurrent breast cancer in the dose-escalation phase.
4. Patient has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer by local laboratory.
5. Patient has HER2-negative breast cancer defined as a negative in situ hybridization test or an IHC status of 0, 1+ or 2+. If IHC is 2+, a negative in situ hybridization (FISH, CISH, or SISH) test is required by local laboratory testing.
6. Patient must have either:

   * Measurable disease, i.e., at least one measurable lesion as per RECIST 1.1 criteria or at least one predominantly lytic bone lesion

Exclusion Criteria:

1. Patient who received any CDK4/6 or PI3K inhibitor.
2. Patient has active cardiac disease or a history of cardiac dysfunction including any of the following:

   * History of angina pectoris, symptomatic pericarditis, or myocardial infarction within 12 months prior to study entry
   * History of documented congestive heart failure (New York Heart Association functional classification III-IV)
   * Documented cardiomyopathy
   * Patient has a Left Ventricular Ejection Fraction (LVEF) \< 50% as determined by Multiple Gated acquisition (MUGA) scan or echocardiogram (ECHO)
   * History of any cardiac arrhythmias, e.g., ventricular, supraventricular, nodal arrhythmias, or conduction abnormality in the previous 12 months.
   * On screening, any of the following cardiac parameters: bradycardia (heart rate \< 50 at rest), tachycardia (heart rate \> 90 at rest), PR interval \> 220 msec, QRS interval \>109 msec, or QTcF \>450 msec.

   Systolic blood pressure \>160 or \<90 mmHg
3. Patient is currently receiving any of the following medications:

   * That are known strong inducers or inhibitors of CYP3A4.
   * That have a known risk to prolong the QT interval or induce Torsades de Pointes.
   * That have a narrow therapeutic window and are predominantly metabolized through CYP3A4.
4. Certain scores on an anxiety and depression mood questionnaires
Oral Iron vs. Placebo in Newly Diagnosed Gynecologic Oncology Patients Who Are Surgical Candidates.

The prevalence of anemia in gynecologic oncology new patients has been seen in previous studies to be as high as 35-59%. this population includes women with several types of gynecologic malignancies. Therefore, it is assumed that the origin of the anemia can be due to anemia of chronic disease and iron deficiency anemia. No previous studies have looked at the efficacy of oral iron supplementation with concurrent Vitamin C in women with newly diagnosed gynecologic malignancies.

Hypothesis: In newly diagnosed gynecologic oncology patients who are surgical candidates does treatment with 3-6 weeks of oral ferrous fumarate 300 mg once a day improve the mean change in hemoglobin levels, from baseline to pre-operative, in comparison to placebo.


Eligibility Criteria:
Inclusion Criteria:

* Over the age of 18
* Scheduled for primary operative procedure within 3-6 weeks of initial consult clinic visit with endometrial cancer, uterine sarcoma, cervical cancer, ovarian/fallopian tube cancer or patients with pelvic mass and a high suspicion of a gynecologic malignancy.

Exclusion Criteria:

* Patient with known allergy to ferrous fumarate.
* Patient's on IV Iron or erythropoietin treatment at the time of recruitment
* Patient's who are not primary surgical candidates.
* Patient's with a known hemoglobinopathy or a hypoproliferative hematologic disorder
* Patient who have significant active vaginal bleeding
* Patient who have a hemoglobin \< 80 g/L will be removed from randomization and referred to blood conservation at Sunnybrook Health SCiences Centre.
Revlimid® Capsules General Drug Use-results Surveillance (Relapsed or Refractory FL and MZL)

To ascertain the safety of Revlimid® Capsules 2.5 mg or 5 mg under the actual use conditions in patients who received R2 combination therapy with the drug and rituximab for the first time for relapsed or refractory follicular lymphoma (FL) or marginal zone lymphoma (MZL).

In particular, this surveillance will collect only information of occurrence state and treatment methods on bone marrow depression (neutropenia), which is specified as a safety specification, as well as on tumor flare, for which attention should be called.

1. Planned registration period 1.5 years
2. Planned surveillance period 3 years from the start of this survey


Eligibility Criteria:
Inclusion Criteria:

- Relapsed or Refractory Follicular Lymphoma or Marginal Zone Lymphoma

Exclusion Criteria:

* N/A