cyrilzakka/clinical-trials huggingface dataset:
Comparison of Surgical Treatment Options for Primary Congenital and Developmental Glaucomas

Newborn and children can be affected by two subgroups of this disease: (1) primary congenital glaucoma (PCG) or (2) developmental glaucoma (DG). The primary aim of this study is to compare the Santen PRESERFLO implant to trabeculectomy in PCG and DG patients as second surgery after failed trabeculotomy or goniotomy.

Glaucoma is a chronic, progressive disease, leading to blindness if untreated or insufficiently treated. It is characterized by a loss of optic nerve fiber and a glaucomatous optic disc excavation and, a corresponding pattern of visual field loss. Newborn and children can be affected by two subgroups of this disease: (1) primary congenital glaucoma (PCG) or (2) developmental glaucoma (DG). PCG and DG are treated surgically, either by goniotomy or by trabeculotomy as first approach, and not with topical hypotensive medications. Whenever these procedures have failed, the subsequent surgical procedure is usually trabeculectomy with Mitomycin C or the implantation of a glaucoma drainage device. However, there is a lack of evidence regarding the "optimal" surgical approach after failed goniotomy/trabeculotomy. Optimal treatment in this young group of patients with a long life expectancy is crucial to prevent blindness, allow them to participate in a "normal" school and work environment, and to minimize disease burdens for these patients and their families as well as to minimize costs for society. Consequently, there is the desire to find a procedure with a superior success rate and even fewer or less severe complications compared to trabeculectomy. Recently, the Santen PRESERFLO was introduced. The results proved fewer complications and comparable efficacy to trabeculectomy, according results presented at scientific meetings. Yet, there are no published studies to compare the both procedures. The primary aim of this study is to compare the Santen PRESERFLO implant to trabeculectomy in PCG and DG patients.

Eligibility Criteria:
Inclusion Criteria:

* Minors younger than 18 years of age with a diagnosis of Primary Congenital Glaucoma (PCG) or Developmental Glaucoma (DG) will be included
* participants must have had a failed trabeculotomy or goniotomy (once or twice) or one 360° trabeculotomy.

Exclusion Criteria:

* Individuals with eye pathologies other than glaucoma or, who underwent intraocular surgery within the last 6 months will not be included.
* patients who will not be willing to proceed with the entire follow-up of 6 months, or whose legal representative did not sign the informed consent will not be enrolled.
Evaluation of miRNAs in Endometriosis

We therefore propose a research project based on the prospective evaluation of miRNAs (blood and salivary) in patients with endometriosis diagnosed (by clinical examination and imaging) or suspected of endometriosis (clinical/radiological discordance) and in need of management in routine care (surgical or medical PMA) in the Endometriosis Expert Center Hospital.


Eligibility Criteria:
Inclusion Criteria:

- Patient aged 18 to 43 years old,

* Patient has dated and signed the consent form,
* Patient affiliated with the French health care system,
* Patients with formal endometriosis diagnosed by clinical examination and imaging or suspicion of endometriosis for which the diagnosis is a source of discrepancy between clinical and radiological data,
* Patient with an indication for medically assisted procreation (MAP) or surgery validated in CPR (in routine care),
* Patient who has had a pelvic MRI,
* Patient who completed the symptom and quality of life questionnaires

Exclusion Criteria:

* Pregnant patient,
* Patient infected with the human immunodeficiency virus (HIV),
* Patient with significant difficulties in reading or writing the French language,
* Patient with a personal history of cancer,
* Patient unable to comply with study and/or follow-up procedures,
* Patient who has objected to the collection of her data.
* Patient participating in another clinical research study.
Safety and Efficacy Study of Icotinib With Intensity-modulated Radiotherapy in Nasopharyngeal Carcinoma

Nasopharyngeal carcinoma (NPC) is a prevalent disease in southeast of China. Radiation therapy with or without chemotherapy is a standard therapy for nasopharyngeal cancer. Cytotoxic chemotherapy plays an important role in the curative treatment of advanced NPC. However, concurrent chemoradiotherapy increased significantly local and systemic toxic effects, which may preclude many patients from proceeding with combined therapy. The epidermal growth factor receptor(EGFR) gene is amplified in 40% and EGFR protein is overexpressed in over 80% of NPC. EGFR overexpression is also associated with shorter survival following chemoradiotherapy in locoregionally advanced NPC. And some basic researches have proved that EGFR tyrosine kinase inhibitors(TKIs) could increase the radiosensitivity and reduce the epithelial-mesenchymal transition (EMT) in NPC cell line. Moreover, distant metastases has been the major cause of treatment failure in NPC. Icotinib hydrochloride is a novel oral EGFR TKIs with low mammalian toxicity(made in China). But base on toxic effects of Icotinib, it may increase toxic effects about skin and mucosa in combination therapy with Icotinib and Intensity-modulated Radiotherapy (IMRT). The prospective study will assess the tolerability and efficacy of Icotinib combined with IMRT in patients with NPC. This regimen is of great interest and it has potential to alleviate the adverse effects, improve patient compliance and better therapeutic ratio.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with histological proof of squamous carcinoma of the nasopharynx.
2. Patients must have ECOG Performance Status of 0-1.
3. Patients should have adequate bone marrow function defined as an absolute peripheral granulocyte count (AGC) of \>/= 1500 cells/mm3, platelet count of \>/= 100,000 cells/mm3; adequate hepatic function with bilirubin \</= 1.5mg/dl, AST and ALT \</= 2x the upper limit of normal; serum creatinine \</= 1.5mg/dl, creatinine clearance \>/= 50 ml/min and INR 0.8 - 1.2.
4. Patients must sign a study specific informed consent form prior to study entry.

Exclusion Criteria:

1. Evidence of metastases by clinical or radiographic examinations.
2. History of malignancy other than non-melanoma skin cancer.
3. Prior chemotherapy or anticancer biologic therapy for any type of cancer, or prior radiotherapy to the head and neck region except for radioactive iodine therapy.
4. Patients with uncontrolled intercurrent disease.
5. Patients with currently active malignancy.
6. Pregnant or lactating women Female patients of childbearing potential who are unwilling to practice adequate contraception during study treatment and for two months after the last administration of study drug.
Prevalence and Effect of Workplace Stress Among Pediatric Dentists

Work-related stress is a pattern of physiological, emotional, cognitive and behavioural reactions to some extremely taxing aspects of work content, work organization and work environment.

Certain work situations are too intense and frequent in nature that exceed an individual's coping capabilities and resources to handle them adequately Dentistry is commonly known as a stressful profession among various occupations. Frequent dealing with different types of patients, working in a very small area for long period of time , exposure to toxic substances , all these factors put the dentist under stress.

Adding to the previous factors, working to uncooperative children with annoying parents, will put pediatric dentistry on the top of the most stressful branches in dentistry.

Stress can affect pedodontists physiologically by increasing their blood pressure, heart rate, breathing rate and excessive sweating which in turn may increase the risk of hypertension and breathing problems.

All Paricipants were informed about the objectives of the study and signed an informed consent before participating in the study.

On the day of work, blood pressure and heart rate will be measured for every pediatric dentist at the beginning of the day before starting any case and will be measured again after 3 hours from continuous work. Then, the two readings will be recorded and compared. This part will help in the physiological assessment of the study.

The psychological part will be assessed by asking the pediatric dentists to answer the questions of the 2 scales. {Appendices (2 \&3)}

There will be a specially designed chart for fulfilling the aim of the study designed by the main investigator, this recording chart is formulated to collect the data from the participants.

The recording chart is composed of 3 sections:

The First Section includes sociodemographic data The Second Section includes psychological assessment in which the score gets by each participant is recorded.

The Third Section includes physiological assessment in which the first and second readings of heart rate and blood pressure are recorded and inspected for any change.

Eligibility Criteria:
Inclusion Criteria:

* Both genders are included
* Postgraduate dentists submitting for master and PHD in pediatric dentistry
* Medically free
* The participants who sign the informed consent

Exclusion Criteria:

* Participants taking drugs affecting nervous system
* Fasting participants
GENSARC 2008 : Medical Economic Evaluation of the Molecular Detection by FISH (Fluorescent in Situ Hybridization) and by PCR (Polymerase Chain Reaction) of Sarcomas Specific Translocations and Amplifications .

The clinical and histological diagnosis of sarcomas is often very difficult. The identification of chromosomal and molecular anomalies, such as amplifications, deletions or fusion genes is a powerful help for establishing a correct diagnosis of sarcomas and their benign counterparts. However, the cost of the cytogenetic and molecular techniques for the detection of these alterations is often a limitation to their use. The aim of our study is to evaluate the direct cost of the molecular techniques in comparison to the cost that would be generated by an appropriate therapy and care management of the patient in case of an erroneous diagnosis.


Eligibility Criteria:
Inclusion Criteria:

* patients with biopsy or excision of sarcoma (suspected or diagnosed)
* sampling reviewed by pathologists
* frozen sampling
* clinical data available

Exclusion Criteria:

* opposition of patient
Therapeutic Education Groups for Childhood Obesity

The goal of this clinical trial is to test the efficacy of an educational therapeutic intervention in treating obesity in a pediatric population.

It aims to verify the differences between the experimental group (group-based program) and the control group (individual program) in respect to the BMI z-score values between baseline measurement (beginning of treatment), final measurement (end of treatment) and 18 months follow-up.

One of the aim of this clinical trial is to verify that the direct management of the emotional and relational aspects of patients and family plays an important role in maintaining the weight changes achieved in the long term.

The potential added value of the present study concerns the better understanding of the role of psychological and emotional aspects in the treatment of childhood obesity and in maintaining results in the long term.

The clinical trial aims to recruit 300 obese children randomized in two groups: experimental group and control group.

Eligibility Criteria:
Inclusion Criteria:

* Obesity (\>= 95th percentile);
* No organic causes of obesity;
* Sufficient understanding and production of Italian language;
* Age between 7 and 17 years old;
* Absence of neuropsychiatric diagnosis;
* Subscription of the Informed Consent from both parents (or legal guardian).

Exclusion Criteria

* Degree of obesity\< 95th percentile;
* Organic causes of obesity;
* Insufficient understanding and production of Italian language;
* Age \<7 or \>17;
* Presence of neuropsychiatric diagnosis;
* One parent (or legal guardian) refuses to subscribe the Informed Consent.
Traditional Chinese Medicine for the Treatment of Perennial Allergic Rhinitis on Gut Microbiota and Immune-modulation

40 allergic rhinitis patients in the acute phase will be enrolled in the study. All the allergic patients should be confirmed those who are over 20 years old and hypersensitive to house dust mite allergens confirmed by MAST test before study. All patients were treated with mixed formula of Chinese medicine for one months.

Perennial allergic rhinitis is an important disease in traditional Chinese medicine (TCM) due to its high prevalence rate in Taiwan. In our previous studies, a new mixed formula of Chinese herbs was evaluated for the treatment of allergic rhinitis. In these studies, we found that immunoduoatory effects of Chinese medicine include: CD4+ T lymphocytes; Regulatory T cells; Dendritic cells, and Regulatory B cells. These results allow us to confirm the immunomodulatory effects of mixed formula of traditional Chinese medicine. In recent years, more and more attention has been paid to the effects of gut microbiota on immune-modulation. Many immunomodulaotry effects of allergic diseases were considered to be closely related to gut bacteria. However, the research on allergic rhinitis is still rare, especially related to TCM treatment. From our previous studies, it has been confirmed that TCM have an immunomodulatory effect on allergic rhinitis. Whether or not they are associated with gut microbiota changes is still unknown. This year, we compared the difference of composition and diversity of gut microbiota of allergic rhinitis patients and normal individual. Indeed, we found it were different between allergic patients and normal individuals. The results of this study will provide us the information to understand whether the immunemodulation of TCM treatment on allergic rhinitis is correlated with the changes of gut microbiota.

Eligibility Criteria:
Inclusion Criteria:

* Volunteer for study enrollment and sign inform consent
* Mite allergy confirmed by MAST test
* Over 20 years old
* Will have their blood collected twice and stool samples
* Allergic rhinitis patients in the acute phase will be treated with mixed formula of Chinese medicine for one months

Exclusion Criteria:

* Women who are pregnant or breast-feeding
* Under treatment of western medicine including steroid, antihistamine, leukotriene inhibitor, immunosuppressant or stop above medication less than one month
* Under acute inflammatory disease such as pneumonia, sinusitis, bronchitis and so on vasomotor type allergic rhinitis
* History of allergy or adverse effect to Chinese herbs, poor compliance of herbal medicine severe organ function impairment, such as heart failure, liver failure, renal failure (eGFR \<60 mL/min/1.73 m2)
Mindfulness Based Cognitive Therapy for Chronic Pain and Comorbid Unipolar Depression

The primary aim of this study is to test the feasibility and efficacy of Mindfulness Based Cognitive Therapy (MBCT) training for the treatment of depressive symptoms in patients with chronic pain. The study also aims to elucidate the mechanisms underlying MBCT on a psychological and neurobiological level. For this purpose the study subjects will fill out several psychological questionnaires related to mindfulness, depression and chronic pain. Moreover this study involves optional fMRI scans of the brain and blood measures before and after the intervention.

Main hypotheses:

1. The MBCT training will be a feasible intervention in patients with chronic pain and co-morbid depression as defined by no occurrence of serious adverse events related to the intervention and a retention rate of more than 70% in the subjects assigned to the MBCT arm.
2. Patients who have completed the MBCT training will demonstrate a significant decrease in depressive symptoms as measured on the Quick Inventory of Depressive Symptomatology - Clinician rated (QIDS-C16), and the Hamilton Rating Scale for Depression (HRSD17) (QIDS-C/HRDS) severity scale for depressive symptoms (the primary outcome measure), compared to the control group.


Eligibility Criteria:
Inclusion Criteria:

* The presence of Chronic Pain, which has persisted for at least 3 months.
* Meets criteria of Major Depressive Disorder, Dysthymic Disorder or Depressive disorder NOS as defined by DSM-IV criteria.
* Have a minimum score of depressive symptoms of \> 10 as rated on the QIDS-C, administered during the screen.
* Able to provide written informed consent.
* Adults 18 years or older
* English-language literacy.

Exclusion Criteria:

* Serious suicide or homicide risk, as assessed by evaluating clinician.
* Severe and unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurological or hematological disease for which hospitalization is likely to be required within the next half year.
* The following DSM-IV disorders: any bipolar disorder (current or past), current psychotic symptoms, or a primary psychotic disorder (current or past). Entry of patients with anxiety disorder will be permitted if the depressive disorder is judged to be the predominant disorder, in order to increase accrual of a clinically relevant sample.
* Active diagnosis of substance abuse or dependence disorders within the last 3 months.
Elobixibat Colonic Motor Function Study

This is a randomized trial of 36 otherwise healthy patients with chronic idiopathic constipation. The purpose of the study is to compare the effects of daily single-dose oral elobixibat and placebo for 7 days on colonic motor effects.


Eligibility Criteria:
Inclusion Criteria:

* Male or female 18-65 years of age
* Body Mass Index of 18-40 kg/m2
* Diagnosis of constipation for 12 or more weeks with symptom onset at least 6 months prior to the diagnosis and insufficient criteria to fulfill a diagnosis of irritable bowel syndrome (IBS), as defined by the Rome III criteria for Functional Constipation
* Stable concomitant medications defined as no changes in regimen for at least 2 weeks prior to the trial period

Exclusion Criteria:

* Structural or metabolic diseases/conditions that affect the gastrointestinal system, or functional gastrointestinal (GI) disorders.
* Use of drugs or agents within the past 2 weeks that alter GI transit including laxatives, magnesium or aluminum-containing antacids, prokinetics, erythromycin, narcotics, anticholinergics, tricyclic antidepressants, selective serotonin reuptake inhibitor and newer antidepressants
* Use of drugs or agents within the past 2 weeks that may add drowsiness and central nervous system (CNS) depression such as barbiturates, benzodiazepines, ethanol, lithium, opioids, buspirone, antihistamines, muscle relaxants, and other CNS depressants
* The patient has a history of bariatric surgery for treatment of obesity; surgery to remove a segment of the GI tract; or surgery of the abdomen, pelvic or retroperitoneal area during the 6 months prior to Screening; or appendectomy or cholecystectomy 3 months prior to screening; or other major surgery 1 month prior to Screening
* Clinical evidence (including physical exam) of clinically significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological, neurological, psychiatric, or other disease that interfere with the objectives of the trial. Any candidate participants with such disorder mentioned will be referred to their general physician
* The Hospital Anxiety and Depression Scale (HADS) will be used to exclude patients with significant affective disorders
Hepatitis C Surveillance With Linkage to Care of Patients From Non-ID Departments in Jiangsu

Due to the occult nature of hepatitis C virus (HCV), it is estimated that less than 5% of people with chronic hepatitis C (CHC) infection knowing their status. The major challenges are that awareness is lacking, reliable diagnostics and testing services are not sufficiently available, and laboratory capacity is weak. In the context of major tertiary hospitals, the well-functioning laboratories would ensure the high-quality HCV testing, which facilitate the identification of inpatients who are unaware of HCV infection. However, given the preliminary data, diagnostic rate of inpatients from non-infectious (non-ID) departments is disturbingly low. A recent study from a major hospital in Jilin province of China showed that 3.36% of inpatients were anti-HCV positive; however, HCV RNA confirmatory testing was not further performed in this study.

From the retrospective cohort in non-ID departments of a tertiary hospital of Jiangsu during 2016 to 2017, only 25.9% (71/273) of patients with anti-HCV antibody (Ab) further had HCV RNA confirmatory test, while 40% (29/71) were identified as CHC. The previous data indicates that insufficient anti-HCV Ab testing and insufficient follow-up of patients with positive anti-HCV Ab from non-ID departments. Indeed, compared to hospitals in Western countries, the infectious department in Chinese hospitals are relative independent from non-ID departments, meanwhile the knowledge of HCV infection is relatively lacking for non-ID physicians. Therefore, an appropriate clinical pathway for integration and linkage of non-ID department and ID departments for diagnosis and care delivery of CHC patients is urgently needed. The investigator aim to establish a feasible clinical pathway and consensus guideline to enhance HCV testing surveillance with linkage to care in non-ID departments. Moreover, the participants with anti-HCV Ab also will be enrolled in the HCV prospective cohort, in which the intervention and clinical outcome of hepatitis will be longitudinally monitored in the future study.


Eligibility Criteria:
Inclusion Criteria:

Retrospective cohort:

1. ≥ 18 years of age.
2. Inpatients from non-infectious department.
3. Documentation of laboratory test indicating positive HCV antibody.

Prospective cohort:

1. ≥ 18 years of age.
2. Inpatients from non-infectious departments.
3. Patients who meet the requirement of HCV antibody screening:

   1. patients with high risk possibility of HCV infection.
   2. patients who will have special or invasive medical operation.
   3. patients with unexplained abnormal liver biochemical laboratory results.

Exclusion Criteria:

Retrospective cohort: Duplicated subjects.

Prospective cohort：Inability or unwillingness to provide informed consent or abide by the requirements of the study.