cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Antibody Detection Tests for Visceral Leishmaniasis Diagnosis in Eastern Africa

According to recent estimates by the World Health Organization (WHO) on eastern Africa, not all visceral leishmaniasis (VL) cases reported are confirmed by a laboratory test, probably due to limited access to accurate diagnostic tests and poor reporting. The main approach for VL diagnosis involves antibody detection using the rK39 rapid diagnostic test (RDT) and alternatively the direct agglutination test (DAT) to confirm clinically suspected cases. Suspected cases with negative rK39 RDT and/or DAT results are referred to facilities where examination of tissue aspirate (spleen, bone marrow, lymph node) by microscopy is available. Unfortunately, the diagnostic performance of rK39 in eastern Africa is suboptimal, particularly in settings with a high VL/HIV co-infection rate. A recently developed RDT, based on the recombinant antigen rK28, may overcome this problem, with studies reporting better performance than the rK39. However, data are not definitive, as studies comparing rK28 RDTs with rK39 RDT are limited. Another recently developed RDT detects immunoglobulin G1 (IgG1) specific to Leishmania and has shown promising results in the Indian subcontinent. This study aims to undertake a multi-country assessment of the performance of rK28 and IgG1 RDTs, as compared to the currently used rK39 RDT.

Primary objective and endpoint: To evaluate the performance of different diagnostic tests in detecting anti-Leishmania antibodies to improve early diagnosis of VL in eastern Africa, in particular Ethiopia, and Kenya. Evaluation of the diagnostic performance of the RDTs for primary VL diagnosis based on estimates of sensitivity, specificity, positive and negative predictive values, as well as the degree of agreement between tests.

Design: Prospective single arm diagnostic accuracy study. Multicountry. With participants being suspected cases of VL

Eligibility Criteria:
Inclusion Criteria:

* Patient with clinical signs compatible with VL.
* Is a first VL episode suspected.
* Patient ≥ 5 years old (≥ 4 years old in Kenya).
* Patient from whom written informed consent can be obtained or signed by parent or legal guardian if patient is under 18 years of age. In the case of minors, assent from the children (12-17 years old in Ethiopia, Uganda and Sudan, and 13-17 years old in Kenya) will be obtained, as per country legal requirements.
* Clinical samples required VL diagnosis (peripheral blood, lymph node or bone marrow or spleen aspirate) can be obtained from the patient and patient shows willingness.

Exclusion Criteria:

* Patient already on treatment for VL.
* Patient is a suspected VL relapse case.
* Patient has had previous VL episodes.
* Patients \< 5 years old (\< 4 years old in Kenya).
* Pregnant woman.
* Patient has post/para-kala-azar dermal leishmaniasis (PKDL).
The Association Between Fever and CDKL5 Disorder: a Nationwide Survey

The primary objective of this research is to study the effects of fever on seizure activity in patients with CDKL5 deficiency disorder

The survey aimed to gather information on seizure during and after fever and hot temperature bath therapy from families of children diagnosed with CDKL5 deficiency disorder through the WeChat group. It is expected to to develop new intervention strategies to reduce seizure frequency, improve patient quality of life, and ultimately address the therapeutic challenges faced by the global CDKL5 patient community.

Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of CDKL5 deficiency, including molecular confirmation of a pathogenic or likely pathogenic CDKL5 variant and refractory seizures.
* Parents or guardians are willing to complete and provide information about the child's medical history and fever history after receiving the survey questionnaire online.

Exclusion Criteria:

* Any history of previous brain disease (trauma, etc.) that likely to precipitate seizures.
* Presence of any clinical condition that in the opinion of the principal investigator makes the patient not suitable to participate in the trial.
Testing a Novel Stress-induced Eating Intervention for Cancer Prevention

Subjects will be enrolled in a stress-induced eating intervention with 5, 7, or 9 treatments or control. Treatment will comprise imagining a stressful event, engaging in a stress relief activity (Progressive Muscle Relaxation), and consuming a fruit once per day. There will be one lab visit at baseline in which participants undergo an acute laboratory stressor (i.e., speech and math tasks) and consume food from a buffet. There will be another lab visit at two weeks post-intervention. In the second (and final) lab visit, participants will repeat the acute laboratory stressor (i.e., speech and math tasks) and buffet, and additionally complete questionnaires about their experience in the study.


Eligibility Criteria:
Inclusion Criteria:

* age 18 or older
* fluent in English
* access to an internet-connected device
* reporting a neutral taste and moderate novelty for at least one fruit
* reporting household size-adjusted income less than or equal to 200% of the federal poverty threshold
* perceived stress scale score of 21.82 (1 SD above the national mean)
* BMI 25
* scoring 3.23 on the Dutch Eating Behavior-Emotional Eating Questionnaire

Exclusion Criteria:

* on a diet that would compel them to refrain from eating food in the laboratory buffet
* allergy to any foods presented in the buffet
* selecting a fruit as one or more of top three choices of foods that would make them feel better if stressed
Genomic Imprinting Testing for Diagnosis of Bladder Cancer

Urine analysis provide a promising non-invasive liquid biopsy for diagnosis of bladder cancer. Molecular biomarkers in urine may serve as important diagnostic and prognostic indicators for bladder cancer. Many alterations of genes and proteins have been identified in the urinary for diagnosis of bladder cancer. However, not all bladder cancer patients have the same alterations due to tumor heterogeneity. Thus, to reach satisfactory sensitivity and specificity a new diagnostic molecular alteration should exists ubiquitously in cancers. Numerous studies indicate that Loss of imprinting (LOI) exists ubiquitously in cancers and precede morphological changes. The investigators will conduct a prospective evaluation of a panel of LOI changes in urine test for detection and surveillance of bladder cancer patients.

During the progression of tumor, molecular changes in both genomics and epigenomics occur prior to morphological changes in cells and tissues, therefore molecular biological test is more sensitive to detect cancer at early stage. Genomic imprinting is one kind of epigenetic regulation that controls gene expression. In detail, a copy of gene on the certain maternal or paternal allele is silenced through methylation, while the other acts normally. This kind of genes are named imprinting genes. Loss of imprinting and Copy number variation (LOI \& CNV) is epigenetic change that the silenced copy of an imprinting gene is activated through demethylation. Numerous studies indicate that LOI exists ubiquitously in cancers and precede morphological changes. In contrast, LOI rarely happens in normal somatic cells. Therefore, the methylation status of imprinting genes can act as a biomarker to detect and analyze the abnormal cells.

The investigators will develop a couple of common LOI to establish a predictive diagnostic LOI panel in urine with optimal and robust efficacy in diagnosis of bladder cancer by analyzing LOI in urine from bladder cancer patients and control group that without any tumor in urinary system or other organs. Moreover, the changes of LOI in urine collected before and 1 year after transurethral resection of non-muscle invasive bladder cancer (NIMBC) will also be monitored. External consistency validation will be performed on subsequent urine from patients and control participants collection.

Eligibility Criteria:
Inclusion Criteria:

- 1. Patients diagnosed with of bladder cancer by cystoscopy and biopsy. 2. Participants without any tumor disease and willing to attend the study by providing morning urine.

3. Moring urine and available tumor tissue obtained by biopsy. 4. Male or female patients aged \>= 18 years. 5. Participants signed informed consent form.

Exclusion Criteria:

- 1. Age under 18 years 2. Individuals unwilling to sign the IRB-approved consent form and unwilling to follow the protocol to submit the serial urine for test after surgery 3. Comorbidities that will prohibit or make serial urine collection and cystoscopic examination difficult or impossible during follow up.

4. Prior diagnosis of cancer except bladder cancer
PRIOR Study - A Study of Ibandronate (Boniva) in Postmenopausal Women With Osteoporosis or Osteopenia

The purpose of this study is to evaluate treatment adherence to different regimens of ibandronate in postmenopausal women with osteoporosis or osteopenia who are intolerant to daily or weekly alendronate or risedronate therapy due to gastrointestinal (GI) side effects. The anticipated time on study treatment is 12 months, and the target sample size is 517 individuals.


Eligibility Criteria:
Inclusion Criteria:

* Women with postmenopausal osteoporosis or osteopenia
* Discontinuation of daily and /or weekly alendronate or risedronate therapy because of GI intolerance (eg, heartburn, acid reflux, stomach upset)

Exclusion Criteria:

* Inability to stand or sit upright for 60 minutes
* Inability to swallow a tablet whole - Hypersensitivity to any component of Boniva
* Malignant disease diagnosed within previous 10 years (except resected basal cell cancer); contraindications for calcium or vitamin D therapy
* Patients who do not fulfill a minimum 3 months wash-out therapy from any previous bisphosphonate therapy
Double Helix Design Defocus Lens Spectacle (RACE) for Myopia Control

This study uses 1.585 double helix defocus lens PC lenses with a unique optical design that includes a globally coherent visible area and complementary left and right helices that can form clear images. In addition, the helical arrangement and reduced slit area can generate defocusing signals, inhibiting the development of myopia. Therefore, based on previous research, this study plans to evaluate the safety and effectiveness of 1.585 double helix defocus lens PC frame eyeglasses in controlling the progression of myopia in children and adolescents through a randomized controlled clinical trial.


Eligibility Criteria:
Inclusion Criteria:

1. Race: Chinese children and adolescents.
2. Age 6-13 years, gender unrestricted.
3. Cycloplegic refraction SER: -0.75DS\~-5.0DS in both eyes.
4. Best corrected visual acuity of both eyes reaches 1.0 (0.00 logMAR 6/6).
5. Refractive astigmatism and astigmatism are no more than 1.5D.
6. During the study period, willing to wear glasses provided by the researcher only (\>10 hours) and without additional interventions.
7. Willing to be randomly assigned.
8. Able to sign an informed consent form with the accompaniment and understanding of parents or guardians.

Exclusion Criteria:

1. Allergic or intolerant to medications used for ciliary muscle paralysis.
2. Received any nearsightedness treatment such as atropine, rigid gas permeable contact lens, bifocal/progressive lens, red light therapy, or acupuncture within 30 days before the study.
3. Received defocus lenses for nearsightedness treatment in the past.
4. Diagnosed with any eye disease other than nearsightedness, including strabismus (esotropia greater than 8 prism diopters or exotropia greater than 12 prism diopters), corneal diseases, conjunctival or eyelid damage or other conditions (such as keratoconus, herpes simplex keratitis, etc.).
5. History of eye surgery (including strabismus correction surgery).
6. Eye or systemic diseases that might be associated with nearsightedness or its progression, such as Marfan syndrome, retinopathy of prematurity, diabetes, etc.
7. Anatomical or dermatological factors that may interfere with the wearing of spectacle frames.
8. Other reasons that the researcher deems inappropriate for the participant to be included in the study, such as excessively high expectations for the effectiveness of defocus lenses, or plans to use other nearsightedness intervention strategies simultaneously with the study.
Use of Nutraceuticals in Clinical Practice

The aim of this study will be to evaluate the use of the nutraceutical with cardio-metabolic actions in clinical practice in addition to a Mediterranean diet scheme, normally recommended in the clinic. In particular the study will analyze how much the nutraceutical is prescribed and what are the purposes for which it is used and at what dosages.

The aim of this study will be to evaluate the use of the nutraceutical with cardio-metabolic actions in clinical practice in addition to a Mediterranean diet scheme, normally recommended in the clinic. In particular the study will analyze how much the nutraceutical is prescribed and what are the purposes for which it is used and at what dosages. In particular, attention will be focused on the following substances: berberine (500-1000 mg/day), monacolin (5-10 mg/day), phytosterols (0.9-1.8 g/day), resveratrol (100-500 mg/day), omega-3 (1-3 g/day), alpha lipoic acid (400-800 mg/day), curcumin (400 mg/day), psyllum (3.5 g/day), coenzyme Q10 (100-200 mg/day), inositol (250-600 mg/day), glucomannan (1-4 g/day), chitosan (800-1200 mg/day), guar fiber (10-20 g/day), L-arginine (250 mg/day).

Eligibility Criteria:
Inclusion Criteria:

Diabetic patients in primary and secondary prevention or Hypertensive patients in primary and secondary prevention or Dyslipidemic patients in primary and secondary prevention

Exclusion Criteria:

Patients with hystory of malignancy, and significant neurological or psychiatric disturbances, including alcohol or drug abuse.
Anticoagulation in Gastroesophageal Varices and JAK2 Mutation

Myeloproliferative neoplasms (MPNs), including polycythemia vera, essential thrombocythemia, and primary myelofibrosis, may lead to gastroesophageal varices. The quality of life, morbidity, and mortality of MPN patients mainly depend on disease-related symptoms, thromboembolic and hemorrhagic complications. Previous studies have shown that JAK2 V617F has a prominent role in vascular risk and MPN-associated gastroesophageal varices. The aim of this study is to evaluate the efficacy of anticoagulation in patients with JAK2 mutation and gastroesophageal varices.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients aged 18-75
* diagnosed as portal hypertension by contrast-enhanced computed tomography
* diagnosed as JAK2 positive

Exclusion Criteria:

* not had portal contrast-enhanced computed tomography
* not had JAK2 mutation test
* other factors judged by the investigator that may affect the safety of the subject or the compliance of the trial. Such as serious illnesses (including mental illness) that require combined treatment, serious laboratory abnormalities, or other family or social factors
New Preservative-free Combination of Trehalose, Sodium Hyaluronate and N-acetyl-aspartyl-glutamate (NAAGA) in Dry Eye

The goal of this prospective, non-randomized, non-comparative, monocentric PMCF study is to assess the performance of a new preservative-free combination of trehalose, sodium hyaluronate and NAAGA on DED at 6 months in 30 patients having dry eye disease.

The main questions it aims to answer are:

* To assess the performance and safety of T2769 at 3 months and 6 months.
* To assess patient compliance to therapy.
* To assess the occurrence of dry eye flares. Participants will be asked to use T2769 on a daily basis and complete a self-questionnaire throughout the study.


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged over 18 years,
* Able to give written informed consent prior the initiation of any procedure,
* History of dry eye syndrome for at least 3 months,
* OSDI ≥13,
* Never been treated with artificial tears or with no artificial tears at least 1 month before the enrolment, or not satisfied with current artificial tears.

Exclusion Criteria:

Systemic/non Ophthalmic Exclusion Criteria

* Known or suspected hypersensitivity to one of the components of the IMD,
* History of or active relevant systemic condition incompatible with the investigation or likely to interfere with the investigation results or the patient safety according to investigator judgment.

Specific Exclusion Criteria Regarding Childbearing Potential Women

* Pregnant or breast-feeding women,
* Childbearing potential women neither surgically sterilised nor using an adequate contraception (oral contraceptive, intra-uterine device, subcutaneous contraceptive implant, vaginal ring, patch) .

Exclusion Criteria Related to General Conditions

* Alcohol addiction and heavy smoker according to investigator's judgement,
* Unable to understand the investigation procedures or to give informed consent,
* Non-compliant (e.g., not willing to attend a visit or completing the self-questionnaire; way of life interfering with compliance),
* Participant in this investigation at the same time as another clinical investigation/study,
* Participant in this investigation within the exclusion period of a previous study/investigation with a minimum of one month,
* Participant being institutionalized because of legal or regulatory order, inmate of psychiatric wards, prison or state institutions, or employee or family member of the investigation sites or of the Sponsor's company.

Exclusion criteria related to previous and concomitant treatments (medications/non-medicinal therapies/procedures)

• Participant with previous, current or anticipated prohibited listed treatment (or prohibited modification of treatment regimen).
Surveillance of HFMD in Pediatric Outpatients

The aims of this prospective multicentric study is to determine the types of enteroviruses (EVs) responsible for hand, foot and mouth disease (HFMD) or herpangina in children seen within an ambulatory setting :

* to detect an EV-A71 epidemic or another type associated with atypical forms of the disease at an early stage
* to describe and compare the epidemiological, demographic, clinical and virological characteristics of these infections between the different types of EV.

Any child presenting signs suggestive of HFMD/Herpangina can be included in the study by one of the investigating paediatricians. After giving the information note to the parents (and to children over 3 years of age) and asking them not to object, the paediatrician collects a throat or mouth swab to confirm the enterovirus infection. At the same time as the swab is taken, anonymised demographic and clinical data are collected by the doctor during the consultation. The sample and the information sheet are sent to the National Reference Laboratory for enteroviruses (Clermont-Ferrand University Hospital).The diagnosis is performed by EV genome detection and if positive, genotyping is done to identify the type of the enteroviruses.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 0 to 10 years presenting with HFMD or herpangina

Exclusion Criteria:

* Refusal to participate by holders of parental authority
* Refusal to participate for children over 3 years of age
Comparison of Two Types of Surgery in Treating Patients With Rectal Cancer

RATIONALE: Surgery to remove the tumor may be an effective treatment for rectal cancer. It is not yet known whether one type of surgery is more effective than another for rectal cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of two types of surgery in treating patients who have rectal cancer.

OBJECTIVES:

* Compare local and distant recurrences in patients with mid-rectal cancer treated with wide mesorectal surgical excision with straight colorectal anastomosis versus total mesorectal surgical excision with colonic J pouch coloanal anastomosis.
* Compare the functional, physiological, and anatomical outcomes in these patients treated with these two surgical procedures.
* Compare disease-free survival and overall survival in these patients treated with these two surgical procedures.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to treatment center. Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients undergo surgical resection with a wide mesorectal excision followed by a straight colorectal anastomosis.
* Arm II: Patients undergo surgical resection with a total mesorectal excision followed by a colonic J pouch coloanal anastomosis. Patients then receive a temporary ileostomy which is closed 6 weeks later.

Patients are followed at 6 weeks, every 4-6 months for 2 years, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A minimum of 800 patients (400 per arm) will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Clinical diagnosis of rectal cancer by colonoscopy or barium enema

  * Distal margin of tumor arises within 9-15 cm from the anal verge as measured by rigid sigmoidoscopy
* No synchronous multiple adenocarcinomas
* Candidate for low anterior surgical resection by laparoscopy or conventional open method
* No evidence of gross metastatic disease
* No evidence of peritoneal or pelvic metastases

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* Not specified

Life expectancy:

* At least 6 months

Hematopoietic:

* Not specified

Hepatic:

* Not specified

Renal:

* Not specified

Other:

* No other malignancy within the past 5 years

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* Neoadjuvant or adjuvant chemoradiotherapy allowed

Endocrine therapy:

* Not specified

Radiotherapy:

* See Chemotherapy

Surgery:

* See Disease Characteristics