cyrilzakka/clinical-trials huggingface dataset:
Intervention to Reduce Injection Drug Use

This is a five-year prospective randomized trial comparing two intervention conditions designed to facilitate substance abuse treatment entry and enhance retention in order to reduce the behaviors associated with HIV and HCV risk among injection drug users (IDUs) and to improve client overall functioning. The overall goal of this project is to compare strengths-based case-management (CM) to an enhanced version of CM that uses case managers to facilitate a therapeutic alliance (CM/FTA) among out-of-treatment IDUs in Denver.


Eligibility Criteria:
Inclusion Criteria:

* opiate injection at least 3 times a week during the last 6-months
* 18 years of age or older
* no drug abuse treatment in the 30-days prior to the interview
* not transient
* no known reason (e.g. pending jail time) why they will not be available for follow-up interviews
* not involved in Project Safe research activities in the previous 12 months
* willing to meet with an Addiction Research and Treatment Services (methadone clinic) counselor
* eligible to be treated at ARTS

Exclusion Criteria:

* too intoxicated or impaired mentally to voluntarily consent to participate in the project and/or respond to the interview
Cognitive Training in Stroke Patients

The study aims to investigate the behavioral effects, neural correlates and functional connectivity of cognitive training in patients with stroke

The study will investigate the effects of two cognitive training strategies on behavior, neural correlates and functional connectivity of patients with vascular lesions. The first strategy is associated to the ability to apply efficient organizational semantic category strategy to a list of words. This strategy will be trained in activities similar to everyday life activities. There will be in total 5 sessions, two for measuring the generalization effects before and after training and three sessions to apply the semantic strategy in order to improve encoding and episodic memory performance. The second strategy is related to the ability to remember face-names and the strategy will involve the identification of a salient face feature, creation of a nickname and association of the nickname to the real name. There will be 5 sessions in total, two for measuring the generalization effects before and after training and three sessions to apply the face-name association strategy in order to improve encoding and episodic memory performance. These two cognitive training procedures will be carried out in two separate moments. Before and after each procedure all participants will be examined by functional MRI during resting state and during a active task using a memory encoding paradigm. The same procedure will be carried out with normal control participants.

Eligibility Criteria:
Inclusion Criteria:

* people with chronic vascular ischemic lesions (more than 6 months)

Exclusion Criteria:

* vascular hemorrhages, stenosis, psychiatric problems
Risk Factors of Hepatocellular Carcinomas Developed on Non-fibrotic Liver: Case-control Study (NoFlic Study)

The main objective of this study is to identify direct carcinogenic factors in the absence of cirrhosis, and the carcinogenesis pathways involved on nonfibrotic liver (NfCHC).

Most hepatocellular carcinoma (HCC) complicates cirrhosis, which is often caused by infection with hepatitis B or C viruses, alcohol, obesity, exposure to aflatoxin B1 (AFB1) or hemochromatosis. Nevertheless, 10 to 40% of HCCs can develop on non-cirrhotic terrain and about 5% on nonfibrotic liver (NfHCC). In 20 to 40% of these NfHCCs, no classical HCC risk factor is identified. Some cases could be the result of a transformation of an adenoma. Others may be associated with yet non-formally identified toxins and / or a specific genetic predisposition. While there is a lot of data on alterations of signaling pathways (ß-catenin, AKT / mTOR, Ras / pERK, etc.) in "classical" HCCs, altered pathways remain unknown in most NfHCCs, even in some cases, activation of β-catenin, inactivating mutations of HNF1 or activators of gp130 have been shown. A specific study of NfHCCs, rather rare cancers, represents an opportunity to look for directly carcinogenic factors in the absence of cirrhosis, and to dissect the involved carcinogenesis pathways.

Eligibility Criteria:
Inclusion Criteria:

* CASES: patients aged 18 years and older with a diagnosis of NfHCC with anatomopathological examination and showing a HCC according to standard histopathological criteria and an absence of significant fibrosis in non-tumoral tissues with the METAVIR system score or equivalent (F0 or F1) or the Kleiner et al stage of ASH and NASH (≤stade 2); signed informed consent; affiliated or beneficiary of a social security system
* CONTROLS: patients aged 18 years and older without NfHCC at baseline; patients for whom an endoscopy is programmed as part of an assessment of intestinal functional disorders, dyspeptic disorders or screening colonoscopy or hospitalized patients in orthopedic surgery / traumatology or rheumatology departments; signed informed consent; affiliated or beneficiary of a social security system

Exclusion Criteria:

* CASES: HCC diagnosed without pathological examination; hepatic transplantation before the diagnosis of HCC; patients unable to answer questions; patients who do not speak French or live abroad.
* CONTROLS: History of liver cancer; other cancers under treatment except cutaneous cancers; Colonoscopy indicated in case of familial form of colon cancer; patient with cirrhosis; patients unable to answer questions; patients who do not speak French or live abroad; Relationship or same home with the case
Corticosteroid Nasal Spray in COVID-19 Anosmia

The aim of this study is to evaluate the role of the topical corticosteroids nasal spray (mometasone furoate nasal spray) in improving anosmia in patients recovered from COVID-19 infection.

This study willbe submitted on patients who recently recovered from proven COVID-19 infection and complaining of anosmia or hyposmia.The proven COVID-19 infection will be relied on a positive real-time reverse transcription polymerase chain reaction (rRT-PCR) with samples obtained by a nasopharyngeal swab. The recovery is defined as 2 consecutives negative (rRT-PCR) samples.

Complete medical history will be taken, and essential clinical assessment with appropriate protective measures will be performed in all patients.The patients in the study will be randomly divided into two groups: - Group I: -who will receive topical corticosteroid nasal spray (mometasone furoate nasal spray) beside olfactory training Group II: -who will not receive topical corticosteroid nasal spray but only olfactory training.

As regards the assessment of smell,the patient will assess his smell sensation using familiar substances with distinctive odor. A jar of coffee, a branch of mint and garlic are some used substances. The patient will report the degree of anosmia subjectively with score on a scale from 0 to 10.The assessment of smell will be done initially after recovery/discharge, after 1 week, 2 weeks and after 3 weeks for all patients. The duration of smell loss will be recorded from the onset of anosmia till full recovery of the sensation.

Eligibility Criteria:
Inclusion Criteria:

* adults 18 yrs or older patients
* confirmed case (+ve PCR),
* recovered/discharged (2 -ve PCR),
* suffered from sudden recent anosmia or hyposmia

Exclusion Criteria:

* patients already on nasal steroid
* with previous chronic rhinological pathologies,
* patients on systemic steroid for previous systemic disease,
* anosmia improved before COVID19 recovery,
* pregnancy
* patients who will not complete the follow up period.
Effect of Tranexamic Acid in Upper Gastrointestinal Bleeding

The investigators hypothesize that addition of Tranexamic acid, an antifibrinolytic agent, to conventional therapy will lead to an improved outcome characterized by lower transfusion requirements.

After informed consent is obtained patients will be randomized to receive either Tranexamic acid or placebo in additional to conventional therapy. All patients with gastrointestinal hemorrhage who are admitted to the ICU are managed in consultation with the GI physicians. The ICU team in consultation with the gastroenterology team will manage these patients. Tranexamic acid will be administered in a dose of 1 gm intravenously every 6 hours for four days.

The majority of patients with GI bleeding will spontaneously stop bleeding. However, in those patients that do not and are hemodynamically unstable it poses a significant management challenge. Management of these individuals includes resuscitation followed by endoscopy as well as therapy guided by clinical diagnosis. With optimal therapy mortality in these individuals remains high and the amount of blood transfusion on occasions turns out to be massive and often the outcomes are futile. Tranexamic acid is an antifibrinolytic agent that has been shown to be associated with reduced bleeding and transfusion requirement in surgical patients. We would like to randomize patients to receive either Tranexamic acid or placebo in addition to conventional therapy and monitor outcome.

This study should provide us with information about the efficacy of this medicine in patients with upper GI bleeding. Data from this trial will provide us information about utility of pursuing this modality of therapy.

Eligibility Criteria:
Inclusion Criteria:

* All patients with GI bleed if the following criteria are met:

  * has received 4 units of PRBCs within a 24-hour period, or
  * has orthostatic hypotension (drop in SBP of 20mmHg or drop in DBP of 10mmHg after fluid resuscitation with at least 20ml/Kg of either isotonic fluid and/or PRBCs), or
  * if the MAP remains below 60mmHg after fluid resuscitation, and
  * written informed consent is obtained from the subject or legally authorized representative.

Exclusion Criteria:

* Pregnant or lactating women
* Known to have gastrointestinal malignancy
* On anticoagulation therapy
* Patients with history of thromboembolism
* Patients with history of myocardial infarction or ischemic cerebrovascular accident
* Patient with end stage renal disease
* Patients with DNR status
* Incarcerated individuals
Phase Ⅰa Clinical Trial of a Pneumococcal Vaccine

Infections with Streptococcus pneumoniae often cause serious health problems, especially for infants and the elderly.Failure to cover all polysaccharide types is an even greater problem with adults than with children.

The aim of the study is to preliminary evaluate the safety and immunogenicity of PBPV vaccine compared to placebo,in order to provide a basis for subsequent clinical trial design.

The polysaccharide vaccine protected 60% of elderly adults who were at risk for pneumococcal infection.However, pneumococci are highly diverse with respect to their capsular types , and the polysaccharide-protein conjugate vaccines will not protect against strains of the many capsular types not included in the vaccine.This experimental vaccine was covered 70% of all pneumococcal types, Subjects will receive three doses of PBPV vaccine on day 0,60 and 120 with different contents of 20μg,50μg,100μg each antigen in 18 to 49 years of age.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers aged 18 to 49 years old;
* Willing to provide proof of identity;
* Able to understand and sign the informed consent;
* Able and willing comply with the requirements of the protocol

Exclusion Criteria:

* Hypertensive volunteers with uncontrollable medications (on-site measurement: systolic blood pressure \> 140 mmHg, diastolic blood pressure \> 90 mmHg);
* Abnormal changes of laboratory measures (with clinical significance);
* Woman is pregnant and lactating (by urine pregnancy test)
* Suffered from pneumonia in the past three years;
* Invasive diseases caused by Streptococcus pneumoniae (such as meningitis, bacteremia, pericarditis, peritonitis, etc.) in the past three years;
* Allergic person;
* Any prior administration of blood products in last 3 month;
* Any prior administration of other research medicines in last 1 month;
* Plans to participate in or is participating in any other drug clinical study;
* Any prior administration of attenuated live vaccine in last 14 days;
* Any prior administration of subunit or inactivated vaccines in last 7 days;
* Had fever before vaccination, volunteers with temperature \>37.0℃ on axillary setting;
* According to the investigator's judgment, the volunteers have any otherfactors that make them unfit to participate in the clinical trial
AVANCE-Houston Building Futures Program Evaluation

AVANCE seeks to understand if participation in the AVANCE-Houston Building Futures (A-HBF) program is associated with improved outcomes among the target population of at-risk, homeless, and incarcerated youth. Additionally, the evaluation will examine how and why participant-level characteristics such as relationship status, life status, and demographics are associated with greater or lesser benefit from A-HBF program participation. This research will provide insights about the Survival Skills for Healthy Families curriculum and its effectiveness for the target population that can be used in the development of future programming efforts.

Trauma-informed services are needed to improve self-sufficiency, economic stability, and healthy relationships among at-risk, homeless, and incarcerated youth in Harris County, especially those living in areas with high numbers of single-family households, high poverty rates, low educational attainment, high teen pregnancy rates, high incidence of domestic violence, and high involvement with the (juvenile) justice system. AVANCE-Houston's Building Futures program (A-HBF) aims to facilitate successful transitions to adulthood for cohorts of at-risk and homeless youth by offering healthy relationship and marriage education through the Survival Skills for Healthy Families (SSHF) curriculum.

Developed by Family Wellness Associates, SSHF is an evidence-based curriculum delivered through a series of workshops that focus on communication skills, conflict resolution, knowledge of the benefits of marriage, stress and anger management, parenting skills, financial literacy, job and career advancement, and relationship skills to improve family and economic stability. AVANCE will offer the curriculum via weekly workshops for youth that take place in targeted high-need areas.

AVANCE seeks to understand if participation in the A-HBF program is associated with improved outcomes among the target population of at-risk and homeless youth. Additionally, the evaluation will examine how and why participant-level characteristics such as relationship status, life status, and demographics are associated with greater or lesser benefit from A-HBF program participation. This research will provide insights about the SSHF curriculum and its effectiveness for the target population that can be used in the development of future programming efforts.

Eligibility Criteria:
Inclusion Criteria:

* Youth (aged 14-18)
* High-needs school districts enrolled in grades 9-12
* Residing in juvenile detention center

Exclusion Criteria:

* Adult (age 18 and older)
* Youth (age 14 and younger)
* Not enrolled in school (non-incarcerated youth)
The Success Rate of Cryotherapy Application in Primary Molars With Signs of Irreversible Pulpitis

The study is designed as a randomized controlled trial with two parallel groups. Children aged 5-9 years with primary molars from suffered symptomatic signs of irreversible pulpitis will be randomly assigned into two groups. The first group (experimental group) will be injected with 4% articaine 1:100.000 epinephrine (inferior alveolar nerve block). For the second group, the mandibular second primary molars will be anesthetized using 4% articaine 1:100.000 epinephrine using inferior alveolar nerve block.


Eligibility Criteria:
Inclusion Criteria:

* Healthy children are classified as I or II according to ASA
* Presence of at least one mandibular primary molar with symptomatic signs of irreversible pulpitis
* Presence of at least two-thirds of the root length in periapical radiograph

Exclusion Criteria:

* Unrestorable crowns
* Children with systemic, severe behavior or emotional problems
* Presence of gingival redness, swellings, fistulous of sinus tract
* Radiographic evidence of internal root resorption, pulp stones or calcifications, and/or bone radiolucency
Evaluation of Mallampati Score Changes in Pregnancy

Pregnant patients mallampati class scores will be examined throughout pregnancy

Photographs of the airway will be taken and compared throughout labor and delivery

Eligibility Criteria:
Inclusion Criteria:

* pregnant
* at least 18 years of age

Exclusion Criteria:

* refusal of consent
* known difficult airway
Structured Stroke Management Improves Outcome at 6 Months

Background/Aim of the study: To further reduce the 6 months stroke morbidity and mortality in a high volume stroke hospital and to compare the results with national and international data.

Methods: 204 consecutive stroke patients are analyzed in a prospective study in a single center teaching institution. The intervention consists of a structured therapeutic chain of 290 collaborating GPs, a standardised acute hospital proceeding overlapping with an early integrated neurovascular rehabilitation within the same institution. Primary endpoints include death and dependence at 6 months, secondary endpoints are the length of hospital stay (LOS) and the quantitative analysis of physical and psychosocial impairments. The data are directly compared with the same endpoints of the Swiss subgroup of the international stroke trial (IST).


Eligibility Criteria:
Inclusion Criteria:

* An acute cerebrovascular event (ischemic stroke or intra-cerebral bleeding (ICB)) with the signs and symptoms of an acute stroke according to the World Health Organisation definition of acute stroke14 within the last 12 hours without the need or possibility of a neurosurgical intervention
* No thrombolytic therapy within the first 3 hours (in order to allow the correct comparison with the Swiss cohort of the IST trial
* The informed consent of the patient or, if not possible, of the relatives
* Living at home before the event
* Lack of participation in another trial.

Exclusion Criteria:

* Thrombolytic therapy within the first 3 hours (in order to allow the correct comparison with the Swiss cohort of the IST trial
* No informed consent of the patient or, if not possible, of the relatives
* Not living at home before the event
* Participation in another trial (26 patients were excluded because of TIA with full recovery within 24 hours after the event)
Occupational Performance Problems in Individuals With Rheumatoid Arthritis

Aim: To identify the main occupational performance problems reported by individuals with rheumatoid arthritis and the relationship between these activities with work status of participants . Methods: the investigators conducted a cross-sectional study with 81 patients with RA. Individuals were interviewed the Canadian Occupational Performance Measure. Data was described in frequencies and percentages, and the Pearson's chi-square test was used to determine the asymptotic association between the occupational performance problems with work.

For this cross-sectional study, 81 patients were recruited by convenience at the Clinical Hospital (HC) of the Universidade Federal de Minas Gerais (UFMG), in Brazil.

COPM was applied to identify the main occupational performance problems reported by participants. The COPM is an individual measure of self-awareness about the problems faced when carrying out the activities. It identifies problems in the areas of self-care, productivity, and leisure, and measure the individual's performance and satisfaction regarding these activities

Eligibility Criteria:
Inclusion Criteria:

* over 46 years old;
* diagnosed with RA by rheumatologist (American College of Rheumatology);
* mental competency as assessed with the Mental State Mini-Examination;
* possessed the skills to understand the instructions study.

Exclusion Criteria

* had undergone surgery in the upper limbs.
Safety of Prolonged Administration of Triticum Monococcum in Celiac Disease

Preliminary studies on safety profile of Triticum Monococcum (Tm, a variety of Ancient Wheat) have provided conflicting results with some in vitro and ex vivo studies consistent with non toxicity and other suggestive of toxicity. We recently reported results of a single administration of 2.5 grams of Tm in 12 Celiacs in remission on Gluten Free Diet (GFD), while assessing symptoms and changes of intestinal permeability. Although results of intestinal permeability were inconclusive Tm, but not other type of gluten, was clinically well tolerated.

The aim of the present study was to assess safety of 60 days of administration of Tm (100 grams of water biscuits per day accounting for about 6 grams of gluten from Tm) as judged on clinical, serological and histological parameters in Celiac Disease patients on remission after 1 year of GFD.


Eligibility Criteria:
Inclusion Criteria:

* Adult Celiac patients on Gluten Free Diet (GFD) for at least one year
* Strict adherence to GFD
* Negative Celiac related serology
* Normal duodenal Histology defined as Marsh Class 0-II
* Willing to participate and adhere to study protocol
* Sign of the informed consent

Exclusion Criteria:

* Pregnancy
Enhanced Recovery After Surgery for SPK Transplantation Recipients

108 patients underwent elective SPK surgery were randomly divided into ERAS group (E) and routine care group (T). The ERAS group was consisted of evidenced-based systematic optimization approaches, while the control group received routine care.

Primary results: the postoperative length of stay (LoS) and hospitalization costs; second results: post-operative analgesia score (NRS) , the incidence of post-operative nausea and vomiting (PONV) , urinary catheter removal time by 7 days , post-operative gastric tube indwelling time, the incidence of ambulation within 6 days . the dosage of dobutamine using , the dosage of norepinephrine using, and the total amount of fluid and urine volume . MAP and lactate level . Peak systolic velocity (PSV) and (resistance index) RI of grafts were checked between two groups.

Eligibility Criteria:
Inclusion Criteria:

1. Patients were aged 20-62 years
2. Body mass index (BMI) of 18.5-32.9 kg/m2
3. Voluntary participation for elective SPK surgery
4. ERSD and DN patients waiting for SPK transplantation surgery.

Exclusion Criteria:

1. History of allergy to narcotic drugs
2. cardiopulmonary insufficiency
3. congestive heart failure
4. myasthenia gravis
5. neurological disease
6. mental illness
7. severe liver dysfunction
8. hyperkalaemia
9. malignant hyperthermia
10. unwilling to participate in the study for any reason, or had participated in another study within the 3 months
A Greek-designed ERAS Protocol in Elective Craniotomy

The implementation of ERAS protocol in elective cranial neurosurgical cases in a tertiary hospital.

In this study, the investigators have integrated the most current data from literature aiming to investigate the effectiveness of a contemporary ERAS protocol for elective cranial neurosurgical cases in a tertiary hospital. The hypothesis is that the implementation of such protocol will shorten the postoperative length of stay, minimize the complication rates, and improve the overall clinical status of patients undergoing elective craniotomy compared to the standard perioperative care

Eligibility Criteria:
Inclusion Criteria:

* Medically suitable for elective craniotomy
* ASA-PS I-III

Exclusion Criteria:

* traumatic lesions
* pathology requiring emergent surgery
* preoperative loss of consciousness
* severe co-morbidities that may affect postoperative recovery (e.g. paralysis, autoimmune diseases, myocardial or severe infarction, heart, liver or lung malfunction, severe mental illness etc.)
* recurrent tumor