cyrilzakka/clinical-trials huggingface dataset:
Integrated Care for Patients With High Risk Substance Use and Psychiatric Disorder With Chronic Direct Acting Antiviral Treatment

To determine the effect of an integrated care protocol on antiviral treatment and sustained virologic response (SVR) rates following initiation of direct acting antiviral therapies (DAA) treatments in 2011.

Background and aims: Approval of direct acting antiviral (DAA) therapies in 2011 initiated a new era of more effective treatments for hepatitis C (HCV). The impact of more effective therapies on patient access to treatment is unknown. Integrated Care (IC) involving patient case management may overcome barriers to treatment access imposed by psychiatric and substance use disorders (SUD).

Methods: Prospective, randomized trial at a single medical center. Patients with HCV at risk for active psychiatric and SUD between Jan 2012 and Jan 2013 were recruited and randomized to IC or Usual Care (UC). A mid-level mental health practitioner was placed in the IC clinic and provided brief mental health care and case management.

Eligibility Criteria:
Inclusion Criteria:

* Patients with HCV infection who were referred to the VA HCV clinic and who received the usual initial evaluation in the clinic
* All patients 18 and 75 years old with confirmed HCV infection
* Patients were required to be classified as "high risk candidates for antiviral treatment" on any one of a set of screening measure in order to participate
* Screening measures and cutoffs for inclusion were depression:

  * Beck Depression Inventory: (BDI) \> 10
  * Alcohol use: Alcohol Use Disorders Identification Test (AUDIT-C) \> 4
  * PTSD: VA Primary Care PTSD Screen = endorsement of three or more items or any single endorsement of item #3
  * Drug use: Drug Use Questionnaire = self-reported drug/alcohol use within 6 months prior to screen

Exclusion Criteria:

* Lacked a confirmed test of HCV RNA
* Had HIV/HCV co-infection and received care at San Diego or Palo Alto sites (these patients were treated in a separate clinic)
* Had Hepatitis B (HBV) co-infection
* Had decompensated liver disease with active or recent encephalopathy, variceal bleeding, or ascites or Child-Pugh class B or C
* Had other significant near term life-threatening diseases
* Were treatment non-responders with pegylated Interferon plus ribavirin
Study Of Safety And Efficacy Of PF-04991532 In Subjects With Type 2 Diabetes Mellitus

B2611002 is designed to study how safe and effective an investigational medication (PF-04991532) is in people with Type 2 diabetes. Subjects in the study will receive 1 of 5 treatments for 3 months. One of the treatments will be sitagliptin which is an approved drug, and another treatment will be placebo, which does not contain active ingredient.


Eligibility Criteria:
Inclusion Criteria:

Subjects with type 2 diabetes on stable doses of background medicines for management of diabetes; aged 18-70 years; body mass index between 22.5 and 45.5 kg/m2

Exclusion Criteria:

Subjects with type 1 diabetes, heart attack or stroke in the past 6 months, uncontrolled blood pressure, significant kidney disease.
Randomized Crossover Trial for the Evaluation of the Possible Effects in the Intestine of Two Different Pharmaceutical Forms of L - Thyroxine in Patients With Primary Acquired Hypothyroidism

Thyroid disorders, in particular hypothyroidism, are associated with gastrointestinal impairment, such as celiac disease. A study reported an increased prevalence of celiac disease in a large cohort of children affected by congenital hypothyroidism, underlying the relationship between these two conditions. The hypothesis of our study is that the onset of celiac disorder may be related to the gut concentration of thyroid hormone (TH) in hypothyroidism patients treated with replacement therapy. In fact, TH replacement therapy showed a low bioavailability with a consequent high gut concentration. Two different pharmaceutical formulations (liquid and solid, per os) are available. The liquid one has a better absorption profile and bioavailability than the solid; therefore, it is associated with a low TH intestinal concentration. According to our hypothesis, the solid TH formulation could increase the microbial diversity in the gut instead of the liquid form, due to the high local TH concentration. Based on these findings, the purpose of this study is to evaluate the effect of two different pharmaceutical formulations of TH on the gut in terms of modification of gut microbiota, inflammatory parameters and gut absorption.


Eligibility Criteria:
Inclusion Criteria:

* Children with primary acquired hypothyroidism that require Levothyroxine therapy (naïve patients, \< 18 years)
* Informed consent from parents and patient

Exclusion Criteria:

* Age \< 3 years
* Patients with secondary hypothyroidism, euthyroid sick syndrome or thyroid hormone resistant
* Patients with celiac disease, type I diabetes or other known autoimmune diseases
* Patients with genetic diseases or syndromes, such as Down, Williams-Beuren, Turner
* Assumption of antibiotics, probiotics, prebiotics, or other medications that could affect the gut microbiota in the month before the beginning of the study
* Gastrointestinal infectious diseases in the month before the beginning of the study
* Hypersensitivity to levothyroxine or any of the ingredients contained in the two pharmaceutical formulations
* Untreated adrenal insufficiency, untreated pituitary insufficiency and untreated thyrotoxicosis.
* Patients with cardiovascular disease
* Patients who show with impaired pancreatic function measured using the assay in faecal fat (steatocrit) at the screening visit
Siewert Type II Esophageal Adenocarcinoma: Relationship Between Histology and Survival

In Siewert type II adenocarcinoma, the relationship between adenocarcinoma sub types and survival, histologic/biologic patterns related to the presence/absence of gastric greater curvature metastases, were investigated.

In order to achieve further data on the biological patterns of intestinal and diffuse subtypes of esophageal adenocarcinoma (Lauren's classification), on the frequency of gastric greater curvature nodal stations and on the clinical relevance, in terms of prognosis and survival, of these parameters, a Siewert type II case series of Siewert type II adenocarcinomas, submitted to primary (no neoadjuvant therapy) surgical, studied, operated upon and followed up, were analysed. According to histologic patterns, cases were ordered in intestinal and diffuse adenocarcinoma sub types (Lauren's classification)and distinguished in Barret's, cardiopyloric, gastric types.

Eligibility Criteria:
Inclusion Criteria:

Siewert type II adenocarcinoma \> 18 year submitted to primary surgery

Exclusion Criteria: Siewert type II adenocarcinoma submitted to neoadjuvant therapy.

Siewert type I adenocarcinoma. Siewert type III adenocarcinoma Squamous Carcinoma

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Comparing Google With A Focused Diabetes Search Engine

Abstract Diabetes behavior can be influenced by patients exploring diabetes topics that may lack scientific credibility. The question this study examines is whether a Google or Health on the Net (HON) internet search, presents websites that would incline a more or less likely recommendation to patients ? A preliminary trial suggests that referrers recommend websites based on rules that may prioritize website source over content. This study will qualitatively assess the rules that participants use in deciding which websites are more suitable than others.

Method The investigators will inject a diabetes related search term into a HON and a Google search engine. The top 5 mutually exclusive websites from each search engine will be presented to 5 people from three groups stratified across endocrinologists, informaticians and PCPs. Participants will rank the websites and then identify the rules that they applied to reach their decision.


Eligibility Criteria:
Inclusion Criteria:

* physician, informatician, diabetologist

Exclusion Criteria:

-
Weight and Metabolic Effects of an Almond Enriched Hypocaloric, Low Fat Diet on Overweight and Obese Persons

The purpose of this trial is to study the safety, tolerability and efficacy of an almond enriched hypocaloric diet on weight loss and weight maintenance, as well as on established and emerging cardiovascular risk factors in approximately 112 overweight and obese persons.

A randomized, non-blinded, controlled clinical trial using a parallel design of a hypocaloric, low fat (\<30% energy from fat) diet with or without 2 oz of almonds over 18 months. Interim analyses will be conducted at 3, 6, 9 and 12 months. The study will be divided into 3 phases. Phase 1 (months 0-6) will be an active, intensive weight loss phase. During phase 1, all subjects will meet once a week in the evening for 1.5 hours. Phase 2 (months 6-12) will be a less intensive weight loss phase. During phase 2 groups will meet every other week in the evening for 1.5 hours. The last phase will be the weight maintenance phase or phase 3 (months 12-18).

Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) \> 27 but \<40
* 18-75 years of age
* Men and non-pregnant or lactating women
* Subjects must be willing to comply with all study-related procedures

Exclusion Criteria:

* Uncontrolled hypertension
* Diabetes or use of anti-hyperglycemic medication
* Dyslipidemia requiring prescription drug therapy as defined by NCEP ATPIII guidelines at screening
* Known allergy or sensitivity to nuts
* Known atherosclerotic cardiovascular disease
* History of congestive heart failure
* History of a non-skin malignancy within the previous 5 years
* Any major active rheumatologic, pulmonary, hepatic, renal, dermatologic disease or inflammatory condition
* History of being HIV positive
* History of alcohol or drug abuse
* Weight-loss inducing medications or dietary supplements within 3 months prior to enrollment.
* Weight loss \> 5 kg during the last 6 months
* Participation in an investigational drug study within 6 weeks prior to screening
* Serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study
Follow-Up Of Pregnancies Established During Study NT-03 (Thrive-IVF Follow-Up)

The purpose of this study is to evaluate pregnancy, delivery, and neonatal outcomes in subjects who maintain ongoing clinical pregnancies through Week 10 of gestation in NT-03.

NT-04 is a follow-up study that will include subjects who received at least one dose of study drug and maintain ongoing clinical pregnancies through Week 10 of gestation during NT-03. NT-04 does not involve the administration of study drug treatment.

In NT-03, subjects who achieve an ongoing clinical pregnancy at Week 8 of gestation will undergo a repeat transvaginal ultrasound (TVU) at Week 10 of gestation (4 weeks after last dose of study drug). Subjects who are pregnant at Week 10 of gestation will be enrolled in NT-04.

Subjects in NT-04 will be contacted by telephone every 6 to 8 weeks until Week 38 of gestation, at which time subjects will be contacted every two weeks until confirmation of delivery. Information about pregnancy status and use of prescription medications will be collected at these telephone interviews.

Between Weeks 18 and 22 of gestation, an obstetrical ultrasound will be performed.

Following delivery, additional information will be obtained, including pregnancy outcome, gestational age at delivery, etc. Standardized photographs will be taken as part of a newborn assessment.

Eligibility Criteria:
Inclusion Criteria:

* At least one dose of study drug administered in NT-03
* Ongoing clinical pregnancy at Week 10 of gestation
* Able and willing to enroll in NT-04

Exclusion Criteria:

• None
Results of CRS and Debulking in PMP Patients

The aim of this study was to compare debulking surgery and cytoreductive surgery in patients with Pseudomyxoma Peritonei with respect to efficacy and safety.


Eligibility Criteria:
Inclusion Criteria:

* Patients with radiology histopathology finding of Pseudomyxoma Peritonei

Exclusion Criteria:

* Preformance status WHO \>2 and histopathology shows other origin then Pseudomyxoma Peritonei
Genetic Counselors' Experiences of Moral Value Conflicts With Clients

This study will examine the experience of moral value conflicts among genetic counselors. Previous research has shown that value conflicts do exist among genetic counselors, but little is known about the nature or consequences of these conflicts. This is a sub-study of the "Manifestations and Consequences of Moral Distress Among Genetic Service Providers: An Exploratory Study," which includes genetic counselors, nurses and medical geneticists.

Genetic counselors are recruited for this value-conflict sub-study from among those participating in the Moral Distress study. Participants are interviewed in-depth by telephone about their experiences of moral value conflicts with clients. The interviews cover the following: situations in which the counselor has disagreed with a client's decision or views on a moral level; the counselor's thought processes during and after a session in which conflicts arise; the counselor's feelings and emotions associated with sessions involving a moral value conflict; the counselor's current and previous work settings; the counselor's view of his or her role and responsibility in a client's decision; challenging a client's values or decision; and preparation for value conflicts.

Genetic counselors may be faced with situations in which they disagree on a moral level with the views or decisions of their clients. These moral value conflicts between counselors and their clients may have negative emotional consequences for counselors. Little is known about the range of sources of these conflicts, the approaches counselors take to address them, or the impact they have on the counselor's life and career. This study seeks to gain insight into the nature, sources, and consequences of moral value conflicts among genetic counselors through semi-structured in-depth interviews with approximately 30 genetic counselors. Interview questions will be nested within interviews for a larger study entitled "Moral Distress and Suffering of Genetics Professionals". The discussion will be centered on a personal experience of moral value conflict that the counselor has had with a client. Interviews will be transcribed and subjected to thematic analysis. Such analysis will result in the identification of common themes running through the interviews. An understanding of value conflicts may allow for future interventions to minimize the negative effects of these events.

Eligibility Criteria:
* INCLUSION / EXCLUSION CRITERIA:

A sample of approximately 30 genetic counselors will be interviewed for this study.
Neuromotor Development and Motor Related Health Care in Children with a High Risk Neonatal Period

The overall aim of the study is to evaluate the prevalence of motor- and neurological disorders (cerebral pares and other less severe motor disorders) in Swedish infants with a high-risk neonatal period and to elucidate whether these children receive motor related health care (MRHC) at 2 and or 5,5 years of age.

Specific aims:

1. To evaluate the prevalence of cerebral pares (CP) and other motor impairments in Swedish infants with a high-risk neonatal period (total group and sub-groups), followed up at age 2 and or 5,5 years.
2. To study how retinopathy of prematurity (ROP) affects the risk for later gross and fine motor impairments in children with a high-risk neonatal period, with specific reference to children born extremely preterm.
3. To study the number of children, with a high-risk neonatal period having access to MRHC (defined as having at least one visit over the previous year to a physiotherapist and/or an occupational therapist).

   * To evaluate possible associations between receiving MRHC and maternal-, pregnancy- and neonatal factors.
   * To study the association between receiving MRHC and cognition, motor function, behavior, quality of life and autism spectrum disorders (ASD) at age 2 and 5,5 years.
4. To study if there are regional differences in Sweden in follow-up of CP and less severe motor disorders at the age of 2 and 5,5 years.
5. To assess the completeness and agreement of some developmental and motor disorders, neurosensory impairments and chronical diseases in the Swedish Neonatal Quality Register (SNQ) with the Swedish National Patient Register (NPR) and The Cerebral Palsy Follow-Up Program (CPUP).

Eligibility Criteria:
Inclusion Criteria:

* Included in the SNQ registry and having a follow-up protocol for 2 and/or 5 years of age.

Exclusion Criteria:

* None if the above inclusion criteria ar true.
TiVi Evaluation of Microcirculatory Reactivity of the Skin to Galvanic Stimulation: Effect of Aspirin

Prospective interventional study. The aim is to analyze the effect of usual ongoing treatments over microvascular cutaneous response to galvanic current applications (CIV: current induced vasodilatation) with tissue vitality (TiVi) system on the forearm of subjects referred for ultrasound investigations due to suspicion of peripheral disease. Hypothesis is that the use of aspirin (even at low dose) abolishes the response.

This test could make it possible to detect the functional effects of low dose aspirin without using biological tests. A routine clinical application could be to use this CIV to verify adherence to aspirin.

At admission eligible patients are proposed to participate. Written consent is signed after complete oral and written explanation of the protocol is signed.

No register of non-included patients will be kept. In included patients, in parallel to the routine ultrasound investigation for which the patient is referred, microvascular investigation will be performed as explained later in arm description.

Usual ongoing treatments are obtained by history and recorded. The end of the visit is the end of the participation of the subjects.

Eligibility Criteria:
Inclusion Criteria:

* subjects referred for investigation of peripheral arterial disease.
* Affiliation to the French National healthcare system
* French speaking patients
* Ability to stand still for half a minute.

Exclusion Criteria:

* pregnancy
* inability to understand the study goal
* Patients protected by decision of law
Screening for Patients Admitted to Ain-Shams University Hospitals for SARS-COV-2 (COVID19)

The objective of this study is to screen the patients seeking hospitalization in Ain Shams university hospitals and identify a cost effective tool for continuing screening the patients all through the epidemic period

Study setting: Ain-Shams University Hospitals. It is a campus including the following main hospitals: Gynecology and Obstetrics, Oncology, Pediatrics, Psychiatry, Internal Medicine, surgical, cardiothoracic and Geriatrics.

Study population: All patients needing admission in Ain-Shams University Hospitals are eligible for the study.

Sample size: There is no incidence data published till now. Only the confirmed detected cases have been reported. We assumed that the community cases are around 10 times that of detected cases.

it was estimated to be 1900 patients with 95% confidence level given the frequency of positive screening 0.05% with precision ± 0.1%. 10

The patients will be enrolled in the study using consecutive sample till the sample size is achieved.

Study methods:

Every enrolled patient will be subjected to:

1. An interview questionnaire including personal data ( age, gender, residence , contact details ) , epidemiological data (history of contact to a COVID-19 case, History of travel), clinical data history ( Fever, Cough, sore throat)
2. Reverse Transcription Polymerase Chain Reaction (RT-PCR)
3. Antibody IgM-IgG test for SARS-CoV-2

Statistical analysis:

Data will be validated, cleaned and entered in spreadsheet. SPSS program will be used for analysis.

Qualitative data will be presented in frequency and related percentage. Quantitative data with normal distribution will be presented in mean and standard deviation or median and interquartile for non-normally distributed data.

Incidence of positive screening test among the total will be calculated with 95% confidence interval.

Comparison between groups will be done using relevant suitable parametric or non-parametric tests. A "P" value of 0.05 is decided to be the level of significance.

Risk ratios will be calculated for estimation of risk with 95% confidence interval.

Cost per one positive detected screening test will be calculated (Total cost / total positive cases). The direct and indirect costs will be calculated by the laboratory department.

Ethical considerations:

The protocol will be submitted for approval by the University Ethical Research Committee.

The objectives and methods of the research will be explained to the participants.

An informed consent will be obtained from subjects willing to participate in the research and the subjects are free to withdraw from research anytime.

Confidentiality of the data will be highly secured. Positive cases will be reported to the Ministry of Health and Population (MOHP). The guidelines of isolation and treatment protocol of MOHP will be followed.

Eligibility Criteria:
Inclusion Criteria - All hospitalized patients in Ain-Shams University Hospitals.

Exclusion Criteria:

- Those who refuse to participate in the trial
Polarization Sensitive Optical Coherence Tomography (PS-OCT) for Retinal Imaging

The aim of this pilot study is to assess the ability of a new polarization sensitive optical coherence tomography system to obtain high-quality images of retinal birefringence.

Glaucoma is the second leading cause of blindness in the world. The current clinical standard-of-care procedure to diagnose glaucoma is visual field testing with disc photography. Visual field testing is subjective both in the patient's feedback and the physician's interpretation of this feedback, and disc photography requires a physician's subjective interpretation. As a result, it is estimated that current methods can diagnose glaucoma only after 40% of the nerve fiber layer (NFL) has been lost. Since glaucoma leads to significant changes in both NFL thickness and NFL optical birefringence, non-invasive imaging of these properties could potentially enable diagnosis of glaucoma prior to changes in vision. Optical Coherence Tomography (OCT) is routinely used in retinal imaging, and its ability to detect changes in NFL health is being actively studied. To detect NFL optical birefringence, a specialized variation of OCT termed polarization sensitive OCT (PS-OCT) is required. Because of high noise in PS-OCT images, prior studies have been unable to detect NFL changes in birefringence.

We have recently developed new methods for performing highly sensitive polarization-sensitive OCT. These changes are algorithmic in nature, and use the same optical wavelengths and powers as clinically deployed OCT retinal imaging instruments. In benchtop studies, these algorithmic changes improve the signal-to-noise ratio (SNR) of PS-OCT images. We propose to conduct a pilot study in normal, healthy subjects to evaluate if these changes improve the SNR of NFL birefringence images.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects between the ages of 18-85 years
2. Healthy normal subjects with no significant eye disease, except for mild cataracts
3. Subjects with clear enough cornea or clear enough media to permit imaging
4. Subjects with refractive error between -5.00 sph to +5.00 sph

Exclusion Criteria:

1. Subjects who have occludable narrow angles (without a patent peripheral iridotomy) or any other ocular or systemic pathology, which precludes safe dilation
2. Subjects whose eyes have been dilated for over 6 hours will not be eligible for imaging.
3. Subjects who do not or cannot understand the instructions for the PS-OCT imaging
4. Subjects who are pregnant and/or breastfeeding. Date of last menstrual cycle will also be included.