cyrilzakka/clinical-trials huggingface dataset:
Defining Decision Thresholds for Judgments on Health Benefits and Harms: Study Protocol

The objective of this study is an approach to derive and use decision-thresholds for judgments on health benefits and harms using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) Evidence to Decision (EtD) frameworks.

The objective of this study is to derive decision-thresholds (DTs) for Evidence to Decision (EtD) judgments on the magnitude of health benefits and harms. The study hypothesis is that DTs could discriminate between the four categories for EtD judgments. Explicit DTs, providing an indication for which could be the appropriate judgment for a given scenario, might have the potential to support panels of decision-makers in their work, facilitate a common understanding, and promote consistency and transparency in judgments.

Study investigators will conduct a methodological randomized controlled trial to collect the data that allow deriving the decision-thresholds. They will invite clinicians, epidemiologists, decision scientists, health research methodologists, experts in Health Technology Assessment (HTA), members of guideline development groups and the public to participate in the trial. Then, investigators will investigate the validity of decision-threshold by measuring the agreement between judgments that were made in the past by guideline panels and the judgments that the DTs approach would suggest if applied on the same guideline data.

Eligibility Criteria:
Inclusion Criteria:

The target population of the survey will include:

* clinicians
* epidemiologist
* decision scientists
* health research methodologists
* experts in health technology assessment (HTA)
* and members of guideline working groups
* members from the general public

Exclusion Criteria:

• Prior participation in the survey
Immunologic Responses to Single and Double Doses of COVID-19 Vaccines in Egyptians

The recent Coronavirus Disease 2019 (COVID-19), has caused a global pandemic, and development of safe, effective vaccines is mandatory to return back to pre pandemic life. Many vaccines have been developed and requested by the authorities after the emergency license issued. The main mechanism of protection is through humoral and cell-mediated immune responses that might reduce the potential for disease development or severity. Cytotoxic T cells clear virus-infected host cells and contribute to control of infection. Preliminary data are now available indicating safty and effecacy of different vaccines . The vaccines were tolerated, with induction of neutralizing antibodies and antigen-specific T cells against the SARS-CoV-2 spike protein. The aim of this work is to evaluate the immune responses in adults, aged 25-65 years, up to 8 weeks after vaccination with a single and double doses live inactivated (Sinopharm), mRNA (Pfizer/ Biontech) and viral vector (Oxford/AZ- ChAdOx1 nCoV-19) vaccines. The Th1- response ( interferon-γ and tumor necrosis factor-α cytokine secretion by CD4+ T cells) and antibody production predominantly of IgG1 and IgG3 subclasses as well as CD8+ T cells mono, polyfunctional and cytotoxic phenotypes, will be also measured.


Eligibility Criteria:
Inclusion Criteria:

* healthy adults receiving COVID-19 vaccines

Exclusion Criteria:

* any contraindication of each COVID-19 vaccine as listed by WHO
Economisation of Whipple Resection Using an Ultrasonic Dissection Device

Including 150 randomised patient, the studies aim is to determine whether an economisation and/or improvement in terms of operating time, drainage fluid, blood loss, time of hospitalisation can be found using an ultrasonic dissection device versus traditional surgical methods such as stitches an ligations.The study is performed for patients undergoing partial pancreatoduodenectomy.


Eligibility Criteria:
Inclusion Criteria:

resectable tumor

Exclusion Criteria:

palliative resection
Timing Frozen Embryo Transfer by Following Two Different Methods

This proof of concept study is designed to determine the practicality of using home ovulation tests to enable optimum timing for transfer of frozen embryos in a natural menstrual cycle in comparison to the standard ultrasound and serum monitoring currently conducted by many IVF clinics.

The study will evaluate the ability of home ovulation tests to accurately time Frozen Embryo Transfer (FET) directly compared to standard clinical procedures. In addition, women's likability and stress associated with timing a FET cycle using both methods will be evaluated by collecting qualitative data using standardised questionnaires.

The impact of psychological stress on FET outcome such as implantation rates and viability at first scan will be considered in order to gather information for the design of a larger clinical study and basic financial data will also be collected, in order to pilot a cost-effectiveness evaluation of the two FET timing methods.

A subset of volunteers will collect daily urine samples from day after embryo transfer until confirmation of pregnancy.

Eligibility Criteria:
Inclusion Criteria:

* Women aged 24 to 45 years of age
* Undergoing no more than 5frozen embryo transfer
* Average cycle length between 26 and 35 days
* Willing to provide written informed consent to participate in the study and comply with all study procedures

Exclusion Criteria:

* More than five IVF frozen embryo cycle
* Undergoing FET following cancer treatment
* Self-reported drug or alcohol dependency
* Self-reported history of depression, anxiety and panic attacks
Internet-delivered CBT for Insomnia: Role of Sleep-related Cognitions

The object of this study is to compare internet-delivered treatment for insomnia to a waiting-list. In this study participants are randomized to: 1) online cognitive-behavioral 2) waiting-list. Participants in the waiting-list condition receive treatment after the post-test. The interventions consist of: diary; psycho-education; relaxation exercises; stimulus control/sleep hygiene; sleep restriction; challenging the misconceptions about sleep; and paradoxical exercise. Adult persons with insomnia will be invited via a popular scientific website to fill out online questionnaires. Participants will fill out questionnaires and a dairy at baseline post-test, 3-month follow-up, and 6-month follow-up. In this study we are interested in sleep-related worry and daily complaints measured with a diary. We expect that the online intervention ameliorates both the sleep-related worry and the daily complaints. Furthermore, we expect that the sleep related worry mediates the effect of the intervention on sleep- and daily complaints.


Eligibility Criteria:
Inclusion Criteria:

* Insomnia disorder according to DSM-5
* Sleep onset latency/wake after sleep onset \> 30 minutes , three times or more a week
* Insomnia three months or longer
* Access to internet

Exclusion Criteria:

* Earlier cognitive behavioral treatment for insomnia
* Start other psychological treatment in the last 6 months
* Doing shift work
* Pregnancy or breast feeding
* Schizophrenia or psychosis
* Suicidal plans
* Sleep apnea
* drugs or alcohol abuse
NMDA-enhancing Agent for Treatment of Mild Cognitive Impairment and Mild Alzheimer's Disease

NMDA activation plays an important role in learning and memory. NMDA receptors were found to decrease in the frontal lobe and hippocampus of Alzheimer's disease and mild cognitive function impairment. This study is a randomized, double-blind, placebo-controlled drug trial. All patients will be allocated randomly to 2 groups: (1) NMDA enhancer: DAOI-B group (starting dose: 250-500 mg/d); (2) placebo group. The study period is 24 weeks. The investigators hypothesize that DAOI-B may yield better efficacy than placebo for cognitive function in patients with mild cognitive impairment or mild Alzheimer's disease.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of mild cognitive impairment or mild Alzheimer's
* MMSE between 17-26
* CDR 0.5 or 1

Exclusion Criteria:

* Hachinski Ischemic Score \> 4
* substance abuse/dependence
* Parkinson disease
* epilepsy
* major depressive disorder
* dementia with psychotic features
* major physical illnesses
* severe visual or hearing impairment
Trial Observationnal

The aim of this retrospective longitudinal study was to describe a key factor in the prenatal diagnosis of isolated cleft palate on the axial transverse view, in order to provide better understanding, detection and diagnosis of this anomaly.

Objective: The study aims to evaluate the role of the posterior hard palate angle in the prenatal diagnosis of cleft palate.

Methods: Stored images of the axial transverse view of the fetal secondary palate, obtained at three-level ultrasounds, were used to evaluate the posterior border of the hard palate. The investigators studied the visualization of the posterior nasal spine and the presence of a gap within the hard palate. The investigators also assessed the posterior angle of the hard palate, formed by the posterior borders of the palatine bones next to the most posterior middle point of the palatine bone. The study population comprised 65 consecutive pregnancies of unaffected cases and 17 pregnancies with 24 assessments at different time points, suspected for a cleft palate without cleft lip, including 7 cases of cleft palate, 4 cases of high arched palate and 6 false positive cases.

Eligibility Criteria:
Inclusion Criteria:

- all patients suspected for a cleft palate without cleft lip referred to the Multidisciplinary Center for Prenatal Diagnosis in Poitiers (France) between January 2019 and January 2023.

Exclusion Criteria for the control group:

* major congenital anomalies or chromosomal aberration,
* premature rupture of the membranes,
* fetal demise,
* patients aged under 18 years.
* If the available images did not allow the evaluation of the hard palate, the case was excluded from further consideration.
Prospective Registry of EoSinophilic esOphagitis

This is a prospective registry of all the Eosinophilic Esophagitis (EoE) patients referred to the third level referral centre of San Raffaele Scientific Institute

Primary objective of the study is to create a registry of all EoE patients with \> 18 years of age referring to the Motility and EoE Unit of San Raffaele Hospital, in order to register clinical, endoscopic and histologic data on the disease, to further design and propose future prospective or retrospective studies to increase disease knowledge and foster collaborations with other centers nationally and internationally

Eligibility Criteria:
Inclusion Criteria:

1. Participant is willing and able to give informed consent for participation in the study.
2. The medical product is the standard of care for the patient or the participant is taking the medicinal product according to clinical practice
3. Being diagnosed with EoE as per guidelines of the disease

Exclusion Criteria:

1. No clear diagnosis of EoE
2. Not willing to provide informed consent to the inclusion in the registry
Liver Function Abnormalities in Patients With Acute Heart Failure

The aim of this study is to evaluate liver function test abnormalities and to identify associated cardiac and non cardiac factors mediating hepatic impairment in acute heart failure patients

Cardiac failure has a negative impact on the function of all parenchymatous organs, based both on the low organ perfusion in the left-sided failure and on the venous congestion in the right-sided failure.

The pathophysiology of acute heart failure (AHF) is complex and not fully understood. It has been hypothesized that an episode of acute decompensation affects not only the cardiovascular system itself, but may also deteriorate the function of other organs, c ausing serious clinical consequences. Liver involvement has been mostly described and investigated in patients with chronic HF.

Liver enzyme alterations are usually classified as relating predominantly to liver cell necrosis (signified by transaminase elevations) or predominantly to cholestasis (signified by elevated alkaline phosphatase (AP) level).

Eligibility Criteria:
Inclusion Criteria:

* patients aged 18 yrs or older presenting with AHF

Exclusion Criteria:

* Congenital heart disease
* acute and chronic liver diseases
Biomarkers in DNA Samples From Patients With Chronic Lymphocytic Leukemia Previously Treated With Fludarabine-Based Therapy

RATIONALE: Studying samples of DNA in the laboratory from patients who received fludarabine-based treatment may help doctors learn more about the effects of fludarabine on cells. It may also help doctors understand how well patients respond to treatment.

PURPOSE: This research study is studying DNA samples from patients with chronic lymphocytic leukemia previously treated with fludarabine-based therapy.

OBJECTIVES:

* To identify genetic characteristics associated with the efficacy and toxicity of fludarabine-based treatment in patients with chronic lymphocytic leukemia who participated on E2997.
* To validate these genetic characteristics with a cancer cell model system to confirm association and dissect the mechanism of effect.

OUTLINE: Archived DNA samples are analyzed for genetic characteristics associated with the efficacy and toxicity to fludarabine-based treatment using Affymetrix 6.0 single nucleotide polymorphism arrays. The results are then compared with data of genes identified in a cancer cell model system, and with clinical data (response, toxicity, overall survival, and progression-free survival) associated with each patient sample.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of chronic lymphocytic leukemia
* Archived DNA samples
* Received fludarabine with versus without cyclophosphamide on clinical trial E2997

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
A Study of GlcNAc on Tear Production in NGLY1-CDDG

In patients with NGLY1-CDDG, the disorder can lead to eye damage due to not being able to produce enough tears. This study is being done to see if the dietary supplement, GlcNAc, improves tear production in patients with NGLY1-CDDG.

This study is a multicenter randomized, double-blind, placebo-controlled trial of GlcNAc supplementation for improvement of tear production in NGLY1-CDDG. Clinical history and screening data will be reviewed to determine subject eligibility. If a subject is already on GlcNAc, a washout period of 1 month will be required prior to consent and randomization. Interested subjects who have a molecularly confirmed diagnosis of NGLY1-CDDG will be consented. Baseline data will be collected prior to randomization at treatment initiation. Subjects will then be randomized to placebo or GlcNAc. They will be administered weight-dependent doses of GlcNAc or an equivalent volume of placebo enterally for 6 weeks, followed by open label weight-dependent doses of GlcNAc for 6 weeks. A visit for evaluation and collection of lab samples will be conducted at 6 and 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Previously molecularly confirmed NGLY1-CDDG
* Between the ages of 1 year old to 60 years old
* Parent or legal guardian available to provide consent on behalf of minor subjects or adult subjects who are unable to give informed consent due to developmental disabilities. Willingness of subject or legal guardian to provide consent.
* Non-pregnant, non-lactating female subjects of childbearing potential who are heterosexually active must agree to use a highly effective method of contraception for the duration of the study. A highly effective method of birth control is defined as one that results in a low failure rate (i.e., \&lt;1% per year) when used consistently and correctly, such as oral/injectable/inserted/implanted/transdermal contraceptives, condom with diaphragm, condom with spermicide, diaphragm with spermicide, intrauterine hormone- releasing system, or intrauterine device (IUD), or sexual abstinence. Contraception is not required where at least 6 weeks have passed since sterilization, defined as females having undergone one of the following surgeries: hysterectomy, bilateral tubal ligation or occlusion, bilateral oophorectomy, or bilateral salpingectomy; and males who are vasectomized. Contraception is not required where females are postmenopausal (defined as 12 consecutive months of spontaneous amenorrhea and age ≥51 years)..

Exclusion Criteria

* Hypersensitivity to any of the components of the placebo
* History of treatment with GlcNAc within 28 days of Visit 1
* Participation in another therapeutic trial - the subject will not be permitted to participate in any other drug trial during the blinded phase and during the 28 days prior to Visit 1
* Shellfish allergy
* Planned eye surgery within 3 months of enrollment
* • Females that are pregnant, nursing or less than 6 months postpartum or attempting to conceive
The Effects of Conversion From Cyclosporine to Tacrolimus on the Changes of Cardiovascular Risk Profiles and Serum Metabolites in Renal Transplant Recipients

The purpose of this study is to evaluate the effects of conversion from cyclosporine to tacrolimus on the changes of cardiovascular risk profiles and serum metabolites in renal transplant recipients.

During the past two decades, cyclosporine has proved to be a valuable immunosuppressive drug that has contributed to a significant reduction in the incidence of acute rejection after kidney transplantation. However, cyclosporine is known as a major factor causing cardiovascular death in kidney transplant recipients. Moreover, cyclosporine has an adverse effect on the lipid profile and fibrinolytic system and result in hypertension and cardiovascular disease. Immunosupressive mechanism of tacrolimus is identical that of cyclosporine but it is 100 times more potent T cell inhibitor than cyclosporine. In multicenter study of Europe and United states, tacrolimus showed low incidence of acute rejection and was known to effective in acute rejection resistant to other therapy. Tacrolimus has a lot of advantages compared to cyclosporine in terms of hypertensive and hyperlipidemic effects although evidences are lacking. One study demonstrated cardiovascular risk profile and renal function has been improved in kidney transplant patients after randomized conversion from cyclosporine to tacrolimus Previous study analyzing metabolites of tacrolimus and cyclosporine revealed that differences were observed in the metabolite level of hypoxanthine, lactate, succinate, and taurine between two immunosupressants. The objective of this study is to evaluate changes in cardiovascular risk profiles and metabolite patterns after conversion from cyclosporine to tacrolimus in kidney transplant recipients.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who received a kidney transplant at least 12 months ago prior to enrollment
2. Patients who have kept in unchanged cyclosporine therapy at least for 6 months prior to enrollment.
3. Female patients of childbearing potential must have a negative urine or serum pregnancy test prior to enrollment, and agreed to the deliberate prevention of conception during the trial
4. Patients who are considered clinically stable by observer's judgment.
5. Patients must understand the purpose and risk of participating the the trial and signed on the written consent.

Exclusion Criteria:

1. Patients who have previously received an organ transplant other than a kidney
2. Patients diagnosed with congestive heart failure within 6 months (EF \<35%)
3. Patients with untreated ischemic heart disease
4. Patients whose hemoglobin is in the level of \<7.0 g/dL
5. Patients who have a known hypersensitivity to tacrolimus
6. Patients taking potassium sparing diuretics
7. Patients newly diagnosed malignant tumors after organ transplant but the patients treated completely with basal or squamous cell carcinoma of the skin are excepted
8. Patients who are at the risk of drug abuse or mental disorders or communicate difficulties with the observer
9. Patients who are pregnant or lactating
Incremental Hemodialysis as a Starting Way of Renal Replacement Therapy

The Hemodialysis Unit of the Hospital Ramon y Cajal is a pioneer in the implementation of a program of incremental hemodialysis, starting with two sessions a week in patients with residual renal function.

The main objective is to compare whether the initiation of hemodialysis with two sessions a week over conventional pattern of initiation of three sessions a week better preserves residual renal function.

The primary specific objective is to assess the loss of renal function defined as 24 hours diuresis less than 100 ml at 12 months of starting treatment. Secondary objectives are: erythropoietin dose, concentration of beta 2-microglobulin, p-cresol, fenol, the state of hydration and nutrition, adverse effects, hospital admissions, mortality and quality of life, comparing both arms of treatment.

DESIGN: Multicenter randomized clinical trial. Randomization will be performed by an external agent that guarantees an homogeneous balance between both arms. The randomization sequence will not be available for the investigators responsible of the patients.

Inclusion criteria: Patients starting hemodialysis that maintain residual diuresis and urea clearance greater than or equal to 2.5 ml / min with a minimum follow-up of one year.

Exclusion criteria: Anuric patients, patients with acute renal failure and patients who start hemodialysis after having going through a renal transplant.

The variables that will be analyzed are 24h diuresis, urea clearance, creatinin clearance, haemoglobin, leukocytes, platelets, creatinin, urea, Na, K, albumin, prealbumin, Ca, P, PTH, PCR, ferritin, B2microglobulin, BNP, KT/V, Erythropoietin dose, state of hydratation and life quality.

Sample size should be of 42 patients on each arm of treatment to obtain a 95% confidence (α=0,05) and a 80% of statistical power (β=0,20).

The normality of the data will be analyzed with Kolmogorov-Smirnov test which will allow to use parametric tests (T-student) or non-parametric tests (U-Mann-Whitney). Association of categoric variables of both arms will be analyzed with Chi2 test, or using Fisher statistic.

Loss of renal function will be analyzed up to 12 months and time studies will be performed through non-parametric test (Kaplan-Meier), obtaining the estimated probability of loss of renal function in both arms and comparing survival functions through "Log-Rank" statistic.

The demonstration of efficacy and safety through a clinical trial would spread this clinical practice in the nephrology community and therefore in our national health system.

Eligibility Criteria:
Inclusion Criteria:

* Subjects starting renal replacement therapy from January 2017 to June 2018.
* Subjects who consent to sign the Informed Consent Form.
* Subject who maintain residual diuresis and urea clearance equal or superior to 2,5 ml/min.

Exclusion Criteria:

* Anuric patients.
* Patients with acute renal failure.
* Patients who revoke the Informed Consent Form.
* Patients who start hemodialysis after having going through a renal transplant.