cyrilzakka/clinical-trials huggingface dataset:
An Innovative Trial Assessing Donor Sex on Recipient Mortality

The iTADS trial will test an important blood donor characteristic - donor sex - to see whether male donor blood leads to a greater benefit for transfusion recipients compared to female donor blood.

The trial will help determine how the investigators can tailor the selection of blood donors based on donor characteristics (e.g. sex) to further improve the safety and optimize the clinical benefit of blood products in Canada.

The investigators have designed an innovative pragmatic randomized trial that will allocate transfusion recipients to receive either only male or only female donor transfusions.

Primary objective:

To confirm that a transfusion strategy of receiving male donor RBC (Red Blood Cell) units only will improve survival compared to a transfusion strategy of female donor RBC units in all hospital patients requiring a transfusion.

Secondary objectives:

1. To assess effects of male RBC units on major morbidities (cancer, infection, end-organ damage)
2. To assess effects across major patient subgroups (major surgery, intensive care, oncology)
3. To assess the effect of female donor pregnancy history on recipient transfusion outcome
4. To build capacity to conduct large innovative prospective pragmatic clinical trials in transfusion medicine using routinely collected clinical and administrative information.

Eligibility Criteria:
Inclusion Criteria:

* All patients (excluding neonates) requiring one or more allogeneic RBC transfusions for the treatment of anemia will be included.

Exclusion Criteria:

* Patients that do not have a valid Ontario Health Insurance Plan (OHIP) number at time of first transfusion
* Patients that require emergent release of a RBC transfusion and in whom emergency randomization could not be completed
* Patients with complex antibody profile in which it is impossible to match RBC units
Study of Pharmacotherapy of Psychotic Depression

This study will determine the effectiveness of combining selective serotonin reuptake inhibitors (SSRIs) with antipsychotic medications in the treatment of psychotic depression.

Approximately 25% of people who are admitted to hospitals for depression suffer from psychotic depression. People with psychotic depression experience hallucinations,and, more commonly delusions, in addition to major depression. Psychotic experiences may be either congruent with the theme of depression or incongruent, without an apparent relationship to feeling depressed. This study will determine the effectiveness of combining a selective serotonin reuptake inhibitor (SSRI) with antipsychotic medication in the treatment of psychotic depression accompanied by at least one identifiable delusion. The study will also evaluate the difference in treatment response of young adults versus geriatric patients.

This double-blind study will last a total of 12 weeks. Participants will be randomly assigned to receive either olanzapine, an atypical antipsychotic drug, combined with sertraline, an SSRI, or olanzapine alone. Following baseline assessments, study visits will occur weekly until Week 6, and then bi-weekly until Week 12. Participants who do not respond to either treatment may leave the study at any time. Participants who achieve either partial or full response may participate in an additional 20-week study.

Eligibility Criteria:
Inclusion Criteria:

* Major depressive disorder, single or recurrent, with psychotic features

Exclusion Criteria:

* History of substance abuse or dependence within the 3 months prior to enrollment
* Acute or unstable medical illness
* Diagnosis of schizophrenia or other psychotic disorders
* Pregnant
* Intolerance to SSRIs or olanzapine
Dietary Treatment of Hyperlipidemia in Women vs. Men

To conduct a dietary intervention trial to test the lipid lowering response to the National Cholesterol Education Program (NCEP) Step Two Diet by free-living hyperlipidemic women and men and to compare the response between them.

BACKGROUND:

Women experience as much illness from hardening of the arteries including stroke and heart disease as do men, but because women experience them later in life, the importance of heart disease, cholesterol, and diet for women has been under appreciated.

DESIGN NARRATIVE:

Half of the subjects were randomized to diet instruction with two years of follow-up and half to six months of no intervention followed by the same diet instruction and followup. Control subjects had a fasting blood drawn at three months of the nonintervention period. Having parallel intervention and control groups was necessary to test the efficacy of the NCEP Step Two Diet: The diet was taught to study subjects during eight weekly two hour classes. Follow-up included four individual visits, at three, six, nine, and twelve months, with a dietitian and two group sessions, at 4.5 and 10.5 months, in the first year and two individual visits, at 18 and 24 months, in the second year. Fasting blood samples for lipoprotein lipid analysis and 4-day food diaries were collected at all individual visits. Additionally, medical history, lifestyle characteristics, vital signs, other adherence measures, behavioral factors related to adherence, and serum nutrients for monitoring nutrient sufficiency were collected. Dietitians provided adherence and dietary modification counseling as necessary to help participants maximize their adherence. The primary questions to be answered were: 1) Did the NCEP Step Two Diet effectively lower plasma lipids in hypercholesterolemic (HC) and combined hyperlipidemic (CHL) women and men over six months? 2) Did HC and CHL women have a different response than HC and CHL men? 3) Was response in women influenced by menstrual status and sex hormone exposure?, and 4) Were the behavioral adaptations to dietary modification different between women and men?

Eligibility Criteria:
No eligibility criteria
Neural Circuits for Action Perception

Study the mechanisms underlying action recognition and execution

Subjects will participate in a task where they have to either

1. Perform a movement
2. Observe an actor performing a movement There are three types of actions including different kinematics and grip types The goal is to compare the neural circuits activated by action execution versus action observation.

Eligibility Criteria:
Inclusion Criteria:

* Patients with pharmacologically intractable epilepsy

Exclusion Criteria:

* Any situation that may put the patient at risk
Neonatal Thymus Transplantation in Humans

The goal of this clinical trial is to demonstrate the safety of the neonatal thymus transplant in an adult patient. The main questions it aims to answer are:

* Is the neonatal thymus transplant a safe procedure?
* What is the adverse event profile of the neonatal thymus transplant?

This is a single-subject study; thus, there will not be comparison groups. The participant will receive multidisciplinary supportive care before, during, and after the procedure.

Inadequate thymopoiesis is probably related to autoimmunity, immunodeficiency, and immunosenescence. Enhancing thymopoiesis may be attractive for managing or studying such immunologic phenomena. Thymopoiesis is supported by the adult thymus transplant, as demonstrated in different animal models. Several approaches to enhance thymopoiesis in humans have been reported, which include in-vitro and in-vivo regeneration of the thymus and avascular grafting of allogeneic processed thymic tissue, among others.

Although a supermicrosurgical technique for neonatal thymus transplantation was recently described in rabbits, it has never been described in humans. This technique can be used to perform a neonatal thymus transplantation in humans. If this technique demonstrates to be safe, future studies will follow to investigate its effect on thymopoiesis and its efficacy on different health conditions.

This single-subject, first-in-humans clinical trial aims to demonstrate the safety and investigate the adverse effect profile of the neonatal thymus transplant in an adult with acute myeloid leukemia who is not candidate for bone marrow transplant, nor intensive chemotherapy. This human model not only allows to study the safety of the neonatal thymus transplant, it will also allow to investigate the effect of the procedure on thymopoiesis.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of acute leukemia in palliative care, either myeloid (AML) or lymphocytic (ALL).
* Not candidate for bone marrow transplant.
* Not candidate for intensive chemotherapy.

Exclusion Criteria:

* Past medical history of bone marrow transplant.
* Past medical history of severe cognitive decline or dementia.
* Past medical history of severe liver failure.
* Past medical history of chronic kidney disease (CKD) stage 4-5.
* Past medical history of acute coronary syndrome within the past 90 days.
* Past medical history of acute ischemic stroke within the past 90 days.
* Past medical history of decompensated congestive heart failure (CHF) within the past 90 days.
Effect of Superior Laryngeal Nerve Blocks on Patient Outcomes in Laryngeal Surgery

Patients undergoing surgery on their vocal cord will either receive a numbing injection to their throat or a saline injection during surgery. Symptoms such as how much coughing or pain patients have after surgery, as well as whether patient's voice gets better will be interrogated.


Eligibility Criteria:
Inclusion Criteria:

* Patient is aged 18 years or older at time of consent
* Patient has suspected or confirmed benign vocal fold lesion
* Patient is planning to undergo direct laryngoscopy with excision of the vocal fold lesion
* Patient is English or Spanish speaking
* Patient is not pregnant per self report
* Patient is not incarcerated

Exclusion Criteria:

* Patient is not 18 years of age or older at consent date
* Patient does not speak English or Spanish
* Patient is currently pregnant or plans to become pregnant prior to their study procedure
* Patient has a laryngeal malignancy or found to find a laryngeal malignancy on final pathology
* Patient will not be undergoing direct laryngoscopy with excision of lesion
* Patient is unable to provide consent or complete study activities
* Patient is incarcerated
Efficacy and Safety Trial of ADU-S100 and Pembrolizumab in Head and Neck Cancer

ADU-CL-20 is an open-label, multicenter Phase 2 clinical trial to evaluate the efficacy and safety of intratumoral ADU-S100 (also referred to as MIW815) administered with pembrolizumab in the first-line setting. The population will consist of adults with PD-L1 positive recurrent or metastatic HNSCC.


Eligibility Criteria:
Inclusion Criteria:

* Histological or cytological confirmation of recurrent or metastatic HNSCC
* Measurable disease as defined by RECIST v1.1
* PD-L1 positive

Exclusion Criteria:

* Diagnosis of recurrent or metastatic carcinoma of the nasopharynx, squamous cell carcinoma of unknown primary histology; or salivary gland or non-squamous histologies (e.g. mucosal melanoma)
* Disease amenable to local therapy with curative intent (surgery or radiation therapy with or without chemotherapy)
* Prior systemic anti-cancer therapy (use of chemotherapeutic agents, targeted small molecules, immunotherapy, or monoclonal antibodies) for the treatment of recurrent or metastatic HNSCC
Improving Pediatric Obesity Practice Using Prompts

This study compares the effectiveness of electronic health record (EHR)-based tools to support the management of pediatric obesity in primary care. All clinicians will receive an interruptive "pop-up" alert We will examine the impact -- the added value versus unintended consequences -- of the interruptive alert on the quality of obesity management in pediatric primary care.

The primary specific aims of this study are to:

1. To assess the impact of EHR-based tools for pediatric obesity in primary care. Hypotheses: EHR-based clinical decision support tools that interrupt but support clinical workflow will (1) improve measures of pediatric obesity care quality delivered by clinicians (e.g., addition of obesity to the problem list, recommended screening for comorbidities, and follow-up/referral plans) and (2) result in a reduced rate of BMI increase over one year among children with obesity.
2. To utilize a mixed methods approach with surveys and semi-structured qualitative interviews with clinicians to (1) examine the extent to which the EHR tools positively impact clinicians' awareness, knowledge and adherence to expert guidelines for pediatric obesity management, and (2) to explore the barriers to and facilitators of clinicians' use of the EHR tools and factors that influence adoption.

Eligibility Criteria:
All pediatric primary care providers providing well child care for patients ages 2-17 years-old in the Boston Children's Hospital primary care practices will be eligible for the study. There are no exclusion criteria.
Risk Factors Predicting Serious Complications With Laparoscopic Gastric Bypass Surgery

The rate of serious complications are relatively low in bariatric surgery today, but still 3-4 % will suffer from a serious complication. There are factors known before the surgery or during the operation that are likely to increase the risk for a serious complication. If the investigators are aware of these we can optimize the patients risk factors prior to the operation or at least increase the awareness of the increased risk in some patients given the presence of risk factors.

Data is collected prospectively to the Scandinavian Obesity Surgery Registry. Today all 44 clinics performing bariatric surgery in Sweden submits data on baseline characteristics, operational data and data from a 30 days, 1 year, 2 years and 5 years follow up for all patients. The database is compared annually to the Swedish civil registry to cover all mortality.

From the database we will identify patients who underwent a bariatric procedure between May 1st 2007 and September 30th 2012. Patients undergoing other bariatric procedures than laparoscopic gastric bypass or revisional surgery will be excluded.

The data will be analyzed with "Chi-2" test, logarithmic regression, linear regression or t-test when appropriate. Odds ratio will be calculated.

Eligibility Criteria:
Inclusion Criteria:

Undergoing laparoscopic gastric bypass surgery and included in the Scandinavian Obesity Surgery Registry

Exclusion Criteria:

Undergoing other bariatric procedure than laparoscopic gastric bypass. Revisional surgery is excluded.

Lost to follow up.
Performance Enhancement and Non-Invasive Brain Stimulation

A promising form of enhancing brain function non-invasively involves stimulating the brain using weak magnetic or electric currents. This method is becoming increasingly popular in both clinical and commercial circles; a number of portable, at-home devices are available on the commercial market for personal use. In this study, the investigators aim to determine factors associated with the enhancement of cognitive and motor learning following transcranial direct-current stimulation in healthy young adults. Understanding how participants respond to brain stimulation is critical to maximizing the effectiveness of stimulation and determining its potential as a performance-enhancing aid for mental tasks. Future developments of this study may also inform the capacity of brain stimulation to act as non-drug alternative to treatment for cognitive decline.

This study involves a single session of anodal tDCS, applied over the motor cortex, while performing a task of motor dexterity. Pre and post stimulation evaluations will assess any effects of the stimulation on motor and cognitive performance.

Eligibility Criteria:
Inclusion Criteria:

* Participants must be in good health,
* between 18-35 years of age
* with no prior history of neurological diseases such as multiple sclerosis, Parkinson's disease, stroke with paralysis.

Exclusion Criteria:

* Participants with cardiac stimulators (pace-makers) and those with metal implants in the skull will be excluded.
* Pregnant women will also be excluded.

Participants will be required to fill out a brief health questionnaire to ensure that they have no conditions that would prevent brain stimulation.
Phase 2 Study of VX-950, Pegasys and Copegus in Hepatitis C

To assess the safety of the combination of VX-950, Pegasys and Copegus in subjects with hepatitis C.


Eligibility Criteria:
Inclusion Criteria:

* Infected with hepatitis C virus

Exclusion Criteria:

* Contraindications to peginterferon or ribavirin therapy.
Anti-VEGF Instead of Intraoperative Fan-shaped Photocoagulation in BRVO Combined With Vitreous Hemorrhage

To evaluate the efficacy and safety of Anti-VEGF instead of intraoperative fan-shaped photocoagulation in BRVO combined with vitreous hemorrhage.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years old;
2. BRVO is diagnosed
3. Vitreous hemorrhage
4. Vitreous hemorrhage combined with mild retinal fibrovascular proliferation (early fibrous vascular membrane, thin fibrous vascular membrane, loose retinal adhesion and intact local retinal structure)

Exclusion Criteria:

1. BRVO combined with severe retinal fibrovascular proliferation (long-term fibrovascular membrane, thick fibrous vascular membrane and tightly attached to the retina, deformation of local retinal, retinal tear or suspension of retinal vein )
2. BRVO combined with retinal detachment
3. Retinal veins are completely whitened
4. iris neovascularization or neovascular glaucoma
5. Combined glaucoma
6. combined with other retinopathy
7. Received anti-VEGF treatment within 3 months before surgery
Comparison of Skin Prick Testing Results of Local and Imported Pollen Allergen Extracts and Specific IgE

Pollen allergen extracts are prepared locally and checked for efficacy by comparison to imported allergens and specific IgE.

Skin prick test (SPT) and specific IgE (sIgE) are approved for evaluation of allergen sensitization. Local allergen extracts are cheaper and more available but need standardization. Pollen allergen extracts: Bermuda, Johnson and careless weed are locally prepared and compared mean wheal diameter of skin prick test to imported allergens and also to specific IgE.

Eligibility Criteria:
Inclusion Criteria:

* Positive skin prick test to Bermuda or Johnson or careless weed

Exclusion Criteria:

* Chronic diseases such as heart disease, liver, renal and severe sepsis
* Severe allergic symptoms such as anaphylaxis
* Extensive skin rashes
* Pregnancy
Clinical Comparison of Two Multifocal Contact Lenses Made of Silicone Hydrogel Materials

The purpose of this study was to compare visual performance measures between two multifocal contact lenses on presbyopic wearers.


Eligibility Criteria:
Inclusion Criteria:

* At least 35 years of age.
* Spectacle add of +0.50 to +2.50 diopters (inclusive).
* Currently wearing soft contact lenses at least 5 days per week and at least 8 hours per day.
* Able to be fit in both eyes with soft multifocal lenses in available powers.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Eye injury or surgery within 12 weeks of enrollment in trial.
* Currently enrolled in any clinical trial.
* Astigmatism of 1.00 diopter or more.
* Currently wearing excluded brands of multifocal lenses, as specified by protocol.
* Other protocol-defined exclusion criteria may apply.
Free Gingival Graft Versus Connective Tissue Graft

This study wil compare FGG and CTG for recession coverage in the anterior mandibula.


Eligibility Criteria:
Inclusion Criteria:

* ASA type I and II subjects
* Localized Gingival Recessions
* Recessions Cairo RT I-II-III
* FMPS \< 10%
* FMBS\< 10%
* \<10 cigs/ day
* No contra-indication against oral surgical interventions
* Patient is able to give inform consent

Exclusion Criteria:

* Infection (local or systemic). Each infection will be evaluated prior to study procedure for suitability. Patients with gingivitis or local infection (fracture, apical reaction) will undergo a dental treatment prior to entering the study. In case of systemic infection, the evaluation will be based on medical anamneses, and if necessary will be referred to relevant medical tests.
* ASA type \> II
* Current pregnancy or breastfeeding women
* Alcoholism or chronically drug abuse
* Smokers, ≳ 10 cigarettes per day
* Immunocompromised patients
* Uncontrolled diabetes
* Untreated periodontitis
* History of previous periodontal surgery (mucogingival or other) on the teeth to be included
* Presence of severe tooth malposition, rotation or significant version of the tooth to be treated
* Conditions or circumstances, in the opinion of the investigator, which would prevent completion of study participation or interfere with analysis of study results, such as history of no-compliance or unreliability
Evaluation of a Physical Therapy Protocol on Quality of Life Musculoskeletal Pain and Anxiety in Women With Preeclampsia

The purpose of this study is to verify that the implementation of a protocol physiotherapy musculoskeletal pain and reduces anxiety and improves quality of life in patients hospitalized at the clinic of high-risk pregnancies at the Hospital das Clinicas of Ribeirao Preto, with a diagnosis of preeclampsia and chronic hypertension with superimposed preeclampsia. Where patients will be recruited, answered questionnaires before and after application of physiotherapy protocol.

The hypertensive disorders in pregnancy affect approximately 5-8% of pregnant women worldwide, contributing significantly to serious maternal and fetal complications. There are various forms of hypertensive disorders that occur during pregnancy and among them are pre-eclampsia and chronic hypertension with superimposed preeclampsia. These two disorders present with high blood pressure and proteinuria, which leads often to hospitalization of these women. It is believed that with such an accent hospitalization occur in pain conditions that often affect pregnant women. Given these complications, this study aims to evaluate the effectiveness of a physical therapy protocol used in pregnant women with preeclampsia admitted with respect to blood pressure levels, responses maternal-fetal and perinatal, and measure an expected improvement in quality of life in the reduction of reported pain and anxiety. The study will include the participation of women with preeclampsia and chronic hypertension with superimposed pre-eclampsia, hospitalized, with no significant complications that may hinder the normal progress of pregnancy. Pregnant women will answer questionnaires about quality of life, anxiety and scales to identify musculoskeletal discomfort. Monitoring will be done both the pregnant woman and the fetus through imaging and laboratory, in addition, pregnant women carry the exercise protocol previously proposed work. This is expected to achieve satisfactory results in the improvement of maternal and fetal hemodynamics in aspects of muscle discomfort and quality of life in a secure way for these women.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women with gestational age between 24 and 38 weeks
* Hospitalized in the sector of high-risk pregnancy clinic of the Hospital of Ribeirão Preto with diagnosis of preeclampsia and chronic hypertension with superimposed pre-eclampsia
* With the absence of other maternal diseases and absence of fetal diseases by diagnostic ultrasound examinations and fetal

Exclusion Criteria:

* Pregnant women who became symptomatic (blurred vision, epigastric pain, headache) secondary to the hypertensive process;