cyrilzakka/clinical-trials huggingface dataset:
Cellular Immunotherapy for Patients With High Risk Myelodysplastic Syndromes and Acute Myeloid Leukemia

The main objective of this work is to conduct a clinical study for the development and application of a vaccine with autologous dendritic cells submitted to electroporation with Wilm's tumor 1 (WT1) messenger ribonucleic acid (mRNA), as an adjuvant treatment of high-risk Myelodysplastic Syndromes and Acute Myeloid Leukemia, aiming to delay the progression of the disease or its relapse and increase overall and event-free survival.


Eligibility Criteria:
Inclusion Criteria:

* Individuals between the ages of 18 and 70
* High-risk myelodysplasia (AREB 1 or AREB 2 subtypes) and Acute Myeloid Leukemia
* Minimum interval of 30 days between the last cycle of chemotherapy (when it occurs) and start of immunotherapy
* Performance status between 0 and 3 on the WHO (World Health Organization)-ECOG (Eastern Cooperative Oncology Group) scale
* Calculated creatinine clearance\> 30 ml / min using the Cockcroft-Gault formula
* Total bilirubin less than or equal to twice the lower limit of the normal range in the institution and aspartate aminotransferase (AST) less than or equal to twice the upper limit of normal
* Absence of blasts in peripheral blood
* Leukocyte count greater than 3000 cells / mm3, hemoglobin greater than 9.0 g / dl and platelets greater than 70,000 platelets / mm3, if possible. (If the patient does not meet these criteria for apheresis, the possibility of transfusion of blood components after leukapheresis will be proposed and the patient should sign a specific term of science on the possibility of transfusion)
* Normal cardiac evaluation
* Negative serologies for hepatitis B and C viruses and HIV
* Written informed consent form signed before entering the study

Exclusion Criteria:

* Does not meet any of the requirements of the inclusion criteria
* Low risk myelodysplasia by IPSS (International Prognostic Scoring System) or WPSS (WHO adapted Prognostic Scoring System) scores
* Individuals with a history of any previous neoplasia, except those with prolonged clinical remission (more than 5 years) of non-melanoma skin cancers and cervical cancer in situ
* Pregnant or lactating women
* Previous immunotherapy or biological therapy
Oropharynx (OPX) Salivary Biomarker Study

The goal of this study is to analyze certain biomarkers to look at the relationship between HPV in the saliva, stage at presentation, and a potential self-test compared to saliva of non-cancerous participants.


Eligibility Criteria:
Inclusion Criteria:

* Oropharynx or Oral Cavity Squamous Cell Carcinoma Patients: collected under the OPX Biomarker Protocol (IRB: 19-006036).

Normal Controls:

* Age ≥ 18 years;
* Able to provide informed written consent documenting permission to give saliva sample for research testing.;
* Ability to complete questionnaire(s) by themselves or with assistance.

Exclusion Criteria:

* Oropharynx or Oral Cavity Squamous Cell Carcinoma Patients: collected under the OPX Biomarker Protocol (IRB: 19-006036).

Normal Controls:

* Any personal history of head or neck cancer including head or neck skin cancer.
* Other active malignancy ≤ 5 years prior to registration.
* EXCEPTIONS: Non-melanotic skin cancer, non-metastatic prostate cancer.
* NOTE: If there is a history of prior malignancy, they must not be receiving other specific treatment for their cancer.
* Dry mouth (xerostomia) caused by any chronic (\>30 days) condition (known or unknown) or medication.
* Recent (within 30 days) or active upper aerodigestive tract or anogenital infections.
Effects of Physical Training in iNPH

Patients with idiopathic Normal Pressure Hydrocephalus (iNPH) have variable difficulties regarding gait, balance, cognition and micturition. A shunt operation will improve these difficulties in most cases. Data suggest however, that they do not change their physical activity postoperatively. Physical training has been shown to be beneficial in patients with similar diseases i.e. Parkinson. The aim of this study is to apply a high intensity physical training program after a shunt operation to see if the patients can improve their physical capacity and ambulatory activity more than patients who only receive standardized written advice about physical training.

Consecutive patients with iNPH at the neurological departments of University Hospital of Linköping and at Sahlgrenska University Hospital are included and randomized for either physical training according to a validated training concept for elderly and cognitive impaired patients named HIFE ( High Intensity Functional Exercise) together with a standardized written instruction for home training of physical exercises or only a standardized written instruction for home training. Goal Attainment Scaling will be used to set measurable goals together with the patient. The training will take place in a facility where physiotherapists are available either at the two centers or close to the patient´s home.Those physiotherapists at the centers responsible for the training will contact and send the local physiotherapists a manual and give instructions about the HIFE concept and will also stay in contact for the whole intervention i.e. 12 weeks ( one hour two times a week). A minimum of 18 out of 24 session will be required.

Eligibility Criteria:
Inclusion Criteria:

Shunt-operated patients with Idiopathic Normal Pressure Hydrocephalus diagnosed according the international guidelines from 2005

Exclusion Criteria:

MMSE: equal to and below 16 and/or inability to walk, with or without support , for 10 m.

Other disease, e.g severe heart disease, asthma making intensive physical training impossible.
T-Cell Repertoire Sequencing: Assessing Pembrolizumab Efficacy in Advanced Non-small Lung Cancer

This is a single site, non-randomized trial for the assessment of intravenous (IV) pembrolizumab (also known as MK-3475) combined with pemetrexed/platinum-based chemotherapy in subjects with advanced or metastatic non-squamous non-small lung cancer (NSCLC) who have not previously received systemic therapy for advanced disease and in whom directed therapy is not indicated. Approximately 30 subjects will be enrolled in this trial to examine the clonality and diversity dynamics matched with disease response evaluated by RECIST 1.1.

Subjects will receive pembrolizumab 200 mg combined with pemetrexed and platinum (investigator's choice of cisplatin or carboplatin), as indicated below:

Pembrolizumab 200 mg + pemetrexed 500 mg/m2 (with vitamin supplementation) + cisplatin 75 mg/m2 OR carboplatin AUC 5, all on Day 1 every 3 weeks (Q3W) for 4 cycles followed by pembrolizumab 200 mg + pemetrexed 500 mg/m2 Q3W until progression.

Treatment with pembrolizumab and pemetrexed will continue until 35 trial treatments have been administered, documented disease progression or unacceptable adverse event(s).

Patients will be stratified according to clinical and histopathological parameters: 1. PD-L1 status (PD-L1 \>/= 1 or \<1) 2. Age \< 65 vs =\> 65 3. Smoking history yes vs no 4. Platinum chemotherapy: cisplatin vs. carboplatin 5. Immune-related adverse events (irAEs).

TCR repertoire clonality and diversity will serve as an assessment measure for treatment response, along with PET/CT-scans, tumor exomal profile and ctDNA dynamics.

Eligibility Criteria:
Inclusion Criteria:

* Participant (or legally acceptable representative if applicable) provides written informed consent for the trial.
* Have measurable disease based on RECIST 1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
* Archival tumor tissue sample or newly obtained \[core, incisional or excisional\] biopsy of a tumor lesion not previously irradiated has been provided.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
* Adequate organ function.

Exclusion Criteria:

* Pregnancy or breastfeeding
* Aberration in a known targetable molecular driver.
* Received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor.
* Received prior systemic anti-cancer therapy for metastatic disease.
* Received prior radiotherapy within 2 weeks of start of study intervention.
* Major surgery within 14 days.
* Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy.
* Known additional malignancy that is progressing or has required active treatment within the past 3 years.
* Known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated or asymptomatic brain metastases may participate provided they are radiologically stable.
Testing Response Bias on Sensitive Topics in Self- Versus Enumerator-administered Surveys

Within a survey of adolescent males in Medellin schools (mainly 13-year old boys) the researchers are randomizing whether survey respondents answer sensitive questions themselves or are asked the questions by an enumerator. Questions are of three main varieties: (1) antisocial behaviors, (2) symptoms of depression, and (3) symptoms of anxiety.


Eligibility Criteria:
Inclusion Criteria:

* All male students in seventh grade in a sample of public schools are eligible. The sample corresponds to a representative sample of public schools (we aim at 90 schools)

Exclusion Criteria:

* Female students or students not in seventh grade
Hydrogen and Methane Breath Test Questionnaire

Lactulose HMBT and Glucose HMBT are simple non-invasive tests to assess whether imbalances in gut bacteria may be contributing to troublesome tummy symptoms. These imbalances in gut bacteria include small intestinal bacterial overgrowth (SIBO) and excessive methane production.

Recently there has been a lot of work to done by experts in the field, to ensure that performance and interpretation of these tests are standardised, to help improve the clinical utility of these investigations. Although there is a lot of information currently available demonstrating the risk factors and symptoms associated with these conditions, there is a lack of data demonstrating the factors that might lead to a positive test according to these new parameters. This study aims to collect data on symptoms and medical history, in patients referred for lactulose and glucose HMBT in order further improve the effectiveness of this test in the future.


Eligibility Criteria:
Inclusion Criteria:

1. Participant is referred for and able to complete a postal Lactulose or Glucose HMBT according to protocol with The Functional Gut Clinic
2. Participant has capacity to understand written English
3. Participant can communicate well with the Investigator and to comply with the requirements for the entire study.
A Follow-up Study to Evaluate the Safety of ALLO-ASC-DFU in ALLO-ASC-BI-201 Clinical Trial

This is an open-label follow up study to evaluate the safety for the subjects with ALLO-ASC-DFU treatment in phase 2 clinical trial (ALLO-ASC-BI-201) for 23 months.

This is an open-label follow up study to evaluate the safety for the subjects with ALLO-ASC-DFU treatment in phase 2 clinical trial (ALLO-ASC-BI-201) for 23 months.

ALLO-ASC-DFU is a hydrogel sheet containing allogenic adipose-derived mesenchymal stem cells. Adipose-derived stem cells have anti-inflammatory effect and release growth factors such as vascular endothelial growth factor(VEGF) and hepatocyte growth factor (HGF), which can enhance wound healing and regeneration of new tissue, finally may provide a new option in treating a burn.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects who are treated with ALLO-ASC-DFU sheet in phase 2 clinical trial of ALLO-ASC-BI-201.
2. A subject who is willing to follow the protocol and provide informed consent on screening, given that the information with respect to the clinical trial is provided.

Exclusion Criteria:

1. Subjects who are considered not suitable for the study by the principal investigator.
Acceptability Among Children and Caregivers of Amylase Porridges

Addition of α-amylase is considered as one of most effective solution to improve energy density of cereal based porridges (WHO, 2008). By adding α-amylase, the viscosity of porridges will be decreased while keeping dry matter content constant. Potential positive impact is to significantly improve efficiency of WFP nutritional programmes targeting vulnerable groups suffering from acute malnutrition.

The acceptance of porridges made with α-amylase is tested compared to porridges made without α-amylase among 12-36 months old children and their caregivers. Acceptance is measured based on energy intake. The porridges tested consist of fortified blended Supercereal (12- \<24 months) and Supercereal-Plus (24-36 months) based on Corn Soy Blend (CSB) extruded or drum dried, Wheat Soy Blend (WSB), Rice Soy Blend (RSB), all with and without α-amylase, or a commercial porridge, or eeZee bar.

In total 120 caregiver-child pairs will be recruited in in a rural area in Fada N'Gourma Province, Burkina Faso. In total 240 subjects are included in the study: 80 children aged 12-23.9 months with 80 caregivers and 40 children aged 24-36 months with 40 caregivers. Per group (12-23.9 months or 24-36 months) 10 porridges will be prepare according to cooking instructions at central points of the villages where children are living. The caregiver will feed porridge to their children. Children eat as much porridge as they like. Porridge energy, micro- and macronutrient intake will be determined and porridge viscosity. Children and caregivers are randomly assigned to 10 different porridges, one meal per day and 3 consecutive days per porridge. Total duration is consecutively 30 days. The 120 caregivers will participate in a sensory test. At the end of the study, all caregivers will evaluate sensory of 5 out of the 10 porridges by survey, by ranking and by interview.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 12 to 36 months
* Anthropometry (for children only): MUAC \> 115 mm
* Informed signed consent of parents/caregivers
* Beside breastfeeding, children are used to consume complementary foods

Exclusion Criteria:

* Illness or any medical complications at the recruitment time
* Children already enrolled in any Feeding Program
Safety Evaluation of China Patients: Long-term Treatment Outcome of Conbercept Ophthalmic Injection in Real Word（STONE）

This is a post-marketing drug safety monitoring study in a prospective manner, and data collection will be performed in a registration-follow-up manner. Safety information about patients who have received intravitreal injection of Conbercept Ophthalmic Injection in medical institutions involved in the study during research will be actively monitored without intervening in diagnosis and treatment. All patients enrolled will be followed up for one year.


Eligibility Criteria:
Inclusion Criteria:

1. The condition that informed consent has been freely given prior to research-related procedures;
2. Patients who have received at least one intravitreal injection of Conbercept Ophthalmic Injection after informed consent has been given.

Exclusion Criteria:

1. Patients who have been on any of other anti-VEGF drugs systematically or locally, including but not limited to bevacizumab, ranibizumab and aflibercept, 90 days before enrollment;
2. Those who are on other study drugs or have been on other study drugs 30 before informed consent is given.
Cocoa, Polyphenols, and the Kidney in Healthy Subjects and in Subjects With Hypertension and Diabetes Mellitus

Observing how cocoa effects the cardiovascular and renal system.

Study designed to assess the vascular benefits of drinking Cocoa that is rich in polyphenols. Vascular beds studied will include kidney, brain, eye, and periphery (finger). Time course of the effects will be studied in healthy normal (including elderly), and also in subjects with Type I and Type II diabetes. Renal blood flow will be determined by PAH/In u test clearance. Cranial ultrasound will be used to measure brain blood flow. Retinal blood flow will be assessed by specialized ultrasound/doppler device. Peripheral blood flow is measured by plethysmography. Urine and blood samples will be assayed for routine physiologic parameters, including hormone assessment, and also for the presence of cocoa metabolites.

Eligibility Criteria:
Inclusion Criteria: Diabetes (Type I and II), with or without Hypertension, blood pressure \<165/105

Exclusion Criteria: Under 18 or over 85 years old, women who are pregnant or able to become pregnant, history of heart attack, stroke or chest pain within the past 6 months, kidney disease, heart disease, severe high blood pressure not controlled by medication
Incidence of Phantom Limb Pain and Method of Anesthesia After Lower Extremity Amputation

Phantom limb pain (pain originating from where an amputated limb once was) is a common occurrence after lower extremity amputations, with some sources noting incidence to be as high as 60-80% six months after surgery. This pain can eventually subside, however, cases have been reported of incidence 10 years after surgery. This pain is not only physically detrimental, but can also be psychologically detrimental after a difficult to accept change in the body. Prior studies have been performed using regional anesthetic techniques (including spinals and epidurals) and different medications to attempt to reduce the incidence of phantom limb pain, however, the data have been mostly inconclusive. Of interest, prior studies have not addressed peripheral nerve blocks, a method of anesthesia/analgesia more commonly employed for amputations recently. The purpose of our retrospective study is to look at the incidence of phantom limb pain at our institution over a two year period to determine if peripheral nerve blocks result in a significantly reduced incidence compared to other techniques (spinal, epidural, general anesthesia only). In addition, there is little data on relation of reason for amputation and presence of preoperative neuropathy and incidence of phantom pain. As secondary endpoints, the investigators wish to investigate if certain reasons for amputation (trauma, peripheral vascular disease, diabetes, and others) and/or neuropathy lead to a higher incidence of phantom limb pain. The results of this study could impact future management of patients who are to receive amputations and may lead to further prospective studies on the topics involved.


Eligibility Criteria:
Inclusion Criteria:

* Patients who receive lower extremity amputation

Exclusion Criteria:

* Death or incapacitating medical condition since surgery
Natural Cycle Versus Endometrial Preparation for Healthy Blastocyst Transfer

This study evaluates the difference in pregnancy rate transferring a healthy blastocyst in natural or artificial cycle.

The aim of the study was to verify the implantation capacity and ongoing pregnancy rate of vitrified warmed euploid blastocyst in natural cycle versus endometrial artificial cycle with gonadotropin-releasing hormone (GnRH-agonist) pituitary suppression.

Eligibility Criteria:
Inclusion Criteria:

* frozen-thawed healthy blastocyst

Exclusion Criteria:

* post thawed not survival healthy blastocyst
Project MADD - NIH Underage DUI and Ride

Project MADD was designed to attempt to curb the alarming trends related to drunk driving and to move the field forward by testing a brief parent-intervention's ability to change adolescents' drinking, impaired driving, and riding with impaired driver behaviors. The aim of this project is to provide an easy-to-implement and low-cost alternative parent-based intervention that can be widely disseminated to address this important public health problem.

Drunk driving is a major public health problem. The National Highway Traffic Safety Administration reported nearly 10,000 people died in alcohol-related crashes in the U.S. in 2014. The problem is further magnified when one considers that each year over 1.3 million drivers in the U.S. are arrested for alcohol-impaired driving. As alarming as these statistics are they pale by comparison to estimates indicating that they only represent 1% of the 121 million self-reported episodes of alcohol-impaired driving among U.S. drivers each year. The proposed research will attempt to curb these alarming trends and move the field forward by conducting a randomized controlled trial testing a brief parent intervention's ability to change adolescents' drinking, impaired driving, and riding with impaired driver behaviors. Prior brief parent-based interventions fro this lab have provided sufficient preliminary evidence of participation, communication, and efficacy for changing under-age drinking to warrant a large-scale comprehensive study. The study will use an extremely rigorous design that meets the Society for Prevention Research Criteria for Efficacy as described in Flay et al., a nationally representative sample assessed at 3-waves (baseline, 6 mo. and 12 mo.) to examine generalizability and sustained effects, and an oversampled Hispanic/Latino subgroup to examine the parent-intervention's potential to reduce a health disparity in an underserved population. The aims are as follows: Aim 1: Evaluate the efficacy of the parent intervention (short and long term); Aim 2: Examine mediators of the PBI that directly influence drinking, impaired driving, and riding with impaired driver behaviors; and Aim 3: Identify moderators to help inform future tailoring and improvement in intervention effectiveness. To the extent that the research is successful, it will provide an easy to implement and low cost alternative that can be widely disseminated to address this important public health problem.

Eligibility Criteria:
Inclusion Criteria:

* Parent and teen both consent (forming a dyad testing unit); They are part of GfK's KnowledgePanel pool of participants

Exclusion Criteria:

* Outside of the teen age range
Very Low Dose Oral Anticoagulation and Thromboembolic and Bleeding Complications

We aim to investiagte whether very low dose self management of oral anticoagulation is superior to low dose oral anticoagulation in order to prevent bleeding events in patients undergoing mechanuical heart valve replacement.

In mechanical heart valve recipients, self-management of oral anticoagulation can reduce the risk of developing thromboembolic events and improves long-term survival compared with international normalized ratio (INR) control by a general practitioner. Low-dose INR self-management (INR values of 1.8.-2.8 for aortic valve recipients and 2.5 - 3.5 for mitral or double valve recipients) does not increase the risk of thromboembolic events compared to conventional dose INR self-management. Even in patients with a low INR target range, however, the risk of bleeding events is still higher than the risk of thromboembolism. We therefore perform a prospective, randomized trial in 1,800 patients with mechanical heart valve replacement. During the first six postoperative months, low dose INR self-management will be performed by all patients (INR measurement once a week). Thereafter, 600 patients will continue with this treatment regimen, whereas the other 1,200 patients with perform very low dose oral anticoagulation. Out of these 1,200 patients, 600 will perform INR measurement once a week and 600 patients will perform INR measurement twice a week. Patients are followed up for 24 months.

Eligibility Criteria:
Inclusion Criteria:

* Mechanical heart valve recipients

Exclusion Criteria:

* Contra-indication to phenprocoumon
* Ulcerous disease with bleeding tendency,
* Hypo- or hypercoagulability
* Dementia
* Missing informed consent