cyrilzakka/clinical-trials huggingface dataset:
Socioeconomic Determinants of the Chemical Exposome and Its Genotoxic Effects in Children

PESTIFOL will include children over 8 and under 12 years old of different socioeconomic positions (SEP), mostly living in the region of Pays de la Loire. This approach should enable us to assess the impact of the SEP, and therefore social inequalities, on chemical expositions and DNA damage, and to characterize which (classes/mixture of) pollutants are major source of DNA damage. The study will also address potential effects associated with geographical location on the exposome and its biological consequences.

Growing evidence points to a complex influence of the exposome on health outcomes. Epidemiological studies show associations between pesticides and cognitive delay and cancers. Only few were conducted in children. Chemical exposures differ between socioeconomic groups. The more disadvantaged the group, the higher are some exposures. However, the effect of the exposome on health is complicated to assess due to the long latencies of most diseases. It is therefore important to link social and chemical exposures to 'immediate' outcomes or molecular risk factors for human diseases. There is a strong connection between DNA damage and chronic diseases such as cancers. However, it is difficult to attribute these risks to specific impregnations.

The present study will address the impact of socioeconomic position, hence social inequalities, on environmental exposures and their biological consequences in children. Our approach is to detect DNA damage in hair follicles and associate these measurements with pesticide detections in the hair matrix and socioeconomic position (SEP).

PESTIFOL will include children over 8 and under 12 years old of different socioeconomic positions (SEP), mostly living in the region of Pays de la Loire. This approach should enable us to assess the impact of the SEP, and therefore social inequalities, on chemical expositions and DNA damage, and to characterize which (classes/mixture of) pollutants are major source of DNA damage. The study will also address potential effects associated with geographical location on the exposome and its biological consequences.

Eligibility Criteria:
Inclusion Criteria:

* Children over 8 and under 12 years old at the time of inclusion
* Children in school in class level CE2, CM1 or CM2
* Living in the Pays de La Loire region, at least 80% of the time
* Written informed assent and consent obtained from the participant and both parents or legal representative prior to performing any protocol-related procedures.

Exclusion Criteria:

- Disorder precluding understanding of trial information or informed assent.
The Safety and Efficacy of Human Umbilical Cord Mesenchymal Stem Cells (19#iSCLife®-ACI) in the Treatment of Acute Cerebral Infarction

The purposes of the study is to determine the safety and efficacy of treating acute ischemic stroke patients with human umbilical cord mesenchymal stem cells (hUC-MSC).

This is a randomized, double-blind, paralleled study. 40 patients will be separated into two groups, and receive basic treatment (Aspirin Tablet). Patients in experimental group will receive hUC-MSC once a month, total 3 times. After the treatment, investigator will have follow-up visit for 6 months, evaluate the security and efficacy of hUC-MSC.

Eligibility Criteria:
Inclusion Criteria:

* Patient within 2 weeks onset of symptoms.
* Symptoms and signs of clinically definite acute cerebral infarction patients.
* CT/MRI prove the Oxfordshire Community Stroke Project (OCSP) as Total Anterior circulation infarct (TACI), Partial Anterior circulation infarct (PACI), Posterior Anterior circulation infarct (POCI), or obvious neurological deficit lacunar infarction patient.
* Signed informed consent after understanding all possible benefits and harm.

Exclusion Criteria:

* allergic to basic drug
* with progressive stroke, transient ischemia attach, cerebral infarction with posterior cerebral hemorrhage, and cerebral arteritis.
* tumor, injury, and parasites caused cerebral embolism
* rheumatic heart disease, coronary heart disease, and other atrial fibrillation combined heart disease caused cerebral embolism
* subject is processing thrombolytic therapy
* subject is pregnancy and of childbearing potential or breast feeding
* participate in any other clinical trial in last 3 months
* bleeding tendency patient; severe bleeding tendency in last 3 month
* with gastric duodenal ulcer
* participants with severe liver and kidney, hematopoietic, and metabolic diseases; Or with liver and kidney function examination abnormal
* participants are intolerance with Aspirin Enteric-coated Tablets, or need other antiplatelet drugs
* participants: alcoholism, drug addicted, or other situations may complicated the results
* under other therapy that possibly influence MSC security or efficacy
* investigator supposes not suitable to participate this clinical trail
An Innovative Conversational Agent (Quitbot) for Smoking Cessation

This phase III trial compares two remote digital smoking cessation programs to see how well they work for quitting smoking.

OUTLINE:

Participants are randomized to 1 of 2 groups. Both groups receive access to a 42-day quit smoking program.

GROUP I: Experimental program, for 42 days to support quitting smoking. After the completion of study, patients are followed up at 3, 6, and 12 months.

GROUP II: Control program, for 42 days to support quitting smoking. After the completion of study, patients are followed up at 3, 6, and 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Smokes at least one cigarette a day for the past 12 months
* Wants to quit cigarette smoking within the next 30 days (consistent with text messaging intervention trials)
* If concurrently using any other nicotine or tobacco products, wants to quit using them within the next 30 days
* Interested in learning skills to quit smoking
* Willing to be randomly assigned to either intervention
* Resides in United States (US) and will continue to reside in the US for the next 12 months
* Has at least daily access to their own smartphone
* Has text messaging on their smartphone and knows how to download a smartphone application
* Willing and able to read in English, and
* Not using other smoking cessation interventions (This eligibility requirement helps ensure results are due to the treatments we recommend rather than those that participants are doing on their own.)

Exclusion Criteria:

* The reverse of the inclusion criteria
Effect of Lipopolysaccharide on Skeletal Muscle Functions

The investigators aim to examine how the skeletal muscles of the human volunteers respond to experimental septic conditions to aid understanding of muscle wasting and its biology..

Six healthy men aged 18-30 will be randomly assigned to two metabolic study visits. On the first visit, while resting on a bed, they will have four cannulae inserted including one in the upper thigh, for blood sampling and the infusion of insulin, glucose and normal and tracer amino acids (which allow us to measure muscle protein metabolism). Subjects will receive either injection of purified bacterial product called lipopolysaccharide (LPS) to induce flu-like symptoms or normal saline according to randomization followed by a metabolic test to stimulate muscle synthesis and glucose transport. Three small samples of muscle will be obtained under local anaesthetic from the thigh to measure molecular events in muscle. By performing these measurements, the investigators will determine the consequences of LPS on muscle production and carbohydrate metabolism.

During sepsis, the ability of the body to prevent muscle wasting is impaired resulting in loss of skeletal muscle. In addition, skeletal muscle handling of carbohydrate becomes less efficient. These changes could result in delayed recovery, prolonged rehabilitation and in severe cases mortality of patients. It is still unclear how these changes occur in the human skeletal muscles but animal experiments suggest that protein molecules that are released during sepsis are responsible for these changes. Due to the biological differences between animals and humans in metabolic rate and stability, disease susceptibility and response to infection, simple translation of knowledge from animals to patients could be highly misleading. Therefore, we aim to examine how the skeletal muscles of the human volunteers respond to experimental septic conditions.

Following medical screening, six healthy men aged 18-30 will have two metabolic study visits in a random manner. On the first visit, while resting on a bed, they will have four cannulae inserted including one in the upper thigh, for blood sampling and the infusion of insulin, glucose and normal and tracer amino acids (which allow us to measure muscle protein metabolism). Subjects will receive either injection of purified bacterial product called lipopolysaccharide (LPS) to induce flu-like symptoms or normal saline according to randomization followed by a metabolic test to stimulate muscle synthesis and glucose transport. Three small samples of muscle will be obtained under local anaesthetic from the thigh to measure molecular events in muscle. By performing these measurements, we will determine the consequences of LPS on muscle production and carbohydrate metabolism.

Eligibility Criteria:
Inclusion Criteria:

Male 18-30yrs

Exclusion Criteria:

Clotting disorders Metabolic disease e.g. diabetes, thyroid dysfunction Inflammatory conditions e.g. Crohn's Disease Tobacco smoker Cardiac or Renal pathology Respiratory problems including Asthma Active infectious conditions
Pilot Feasibility of Rice Bran Supplementation in Children

The purpose of this study is to assess feasibility of rice bran consumption in weaning children and to identify dietary rice bran mediated changes to the stool microbiome and stool metabolome.

Rice bran is a globally accessible, underutilized food ingredient with an array of beneficial nutrients (e.g. phytochemicals and prebiotics) that promote health and potentially prevent diseases. The investigators will determine if dietary rice bran intake can modulate the infant gut microbiome and metabolome to promote gut immunity for the benefit of preventing diarrheal diseases that increase risk for malnutrition and stunting.

The investigators hope to learn about the feasibility of dietary supplementation of heat-stabilized rice bran in weaning children living in regions with increased susceptibility to diarrhea and malnutrition, and whether or not rice bran consumption can modulate the stool microbiome and metabolome.

Eligibility Criteria:
Inclusion Criteria:

* Children between the ages of 4-6 months at beginning of recruitment
* Families willing to feed their infant a daily dose of study-provided heat-stabilized rice bran supplementation for 3 months
* Hemoglobin level \>7 g/dl
* Absence of intestinal parasites or malaria infection
* Have not yet received Vitamin A supplementation

Exclusion Criteria:

* Have had a diarrheal episode between 5 and 6 months of age
* Have had a prior hospitalization
* Have had an antibiotic or prophylactic treatment within 1 month prior to participation
* Have an ongoing illness, a known immunocompromising condition, or use of medications
* Hemoglobin level \<7 g/dl
* Presence of intestinal parasites or malaria infection
A Study to Evaluate How the Body Processes 14C-VX-993 After a Single Oral Dose

The purpose of the study is to evaluate the routes and rate of elimination and recovery of total radioactivity (TRA) and characterize the Pharmacokinetic (PK) of VX-993 after a single oral dose of 14C-VX-993

This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4) (A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.)

Eligibility Criteria:
Key Inclusion Criteria:

* Body mass index (BMI) of 18.0 to 32.0 kilogram per meter square (kg/m\^2), inclusive
* A total body weight of more than (\>) 50 kg
* Participants must have at least 1 regular bowel movement per day

Key Exclusion Criteria:

* History of febrile illness or other acute illness that has not fully resolved within 14 days before the first dose of study drug
* Any condition possibly affecting drug absorption, distribution, metabolism, or excretion
* Exposure to any non-environmental radiation within 12 months of dosing
* Participation in more than 1 radiolabeled study (if prior radiation exposure unknown) or participation in more than 3 radiolabeled studies (if radiation exposure known) in the 12 months before dosing or if the annual whole body radiation exposure from previous studies (including this dosing) exceeds FDA-allowed maximum whole body radiation exposure of 5000 mrem

Other protocol defined Inclusion/Exclusion criteria may apply.
To Compare Positron Emission Tomography (PET) Measurements of Fibrillar Amyloid Burden

The purpose of this study is to compare PET measurements of fibrillar amyloid burden using \[18F\]AZD4694.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, of any race or/ethnicity
* ECG, vital signs, and clinical laboratory values are within normal limits at enrollment or deemed not clinically significant by the physician

Exclusion Criteria:

* Significant recent (within 6 months) history of neurological (including stroke) or psychiatric disorder or substance abuse
* Participated in a PET study within the last 12 months
* Pregnancy or lactation
Positive Psychology for Mood Disorders

The investigators are doing this study to see if "positive psychology" can help adults with depression or bipolar disorder.

Positive psychology involves exercises-short tasks-that try to increase good feelings and emotions, like optimism, happiness, personal strengths, and well-being. Positive psychology exercises might include imagining a bright future, being grateful for good events, forgiving others, and doing kind acts for others.

The investigators want to see if practicing positive psychology exercises after leaving the hospital can increase feelings of hope, optimism, and positive thinking. The investigators are asking you to take part in this research study because you are in the hospital for depression or bipolar disorder.

This research study will compare "positive psychology exercises" to "control condition exercises." During the study, you may take part in control condition exercises instead of positive psychology exercises.


Eligibility Criteria:
Inclusion Criteria:

* Patient admitted to Massachusetts General Hospital Inpatient Psychiatric Unit
* Age 18 and older
* Able to read and write in English
* Admission diagnosis of major depressive disorder or bipolar affective disorder (current depressive episode), confirmed using the Mini International Neuropsychiatric Interview and inpatient chart review

Exclusion Criteria:

* Psychotic symptoms, as assessed using the Mini International Neuropsychiatric Interview and inpatient chart review
* Cognitive disorder, assessed using a six-item cognitive screen developed for research
* Primary admission diagnosis of substance use disorder
Sustainable East Africa Research in Community Health

The SEARCH study aims to test evidenced-based innovative community based interventions that lead to the elimination of HIV in rural communities in East Africa using a multi-disease approach. The first phase of the study will quantify the impact of early HIV diagnosis using a streamlined and immediate ART (antiretroviral therapy). The second phase of the study, will quantify the impact of targeted Pre-Exposure Prophylaxis (PrEP) in the context of universal treatment and streamlined care. The study intervention is designed to improve the entire continuum of care, to reduce structural barriers for all populations including those most "at risk".

The SEARCH study aims to test evidenced-based innovative community based interventions that lead to the elimination of HIV in rural communities in East Africa using a multi-disease approach. The first phase of the study will quantify the impact of early HIV diagnosis using a streamlined and immediate ART (antiretroviral therapy). The second phase of the study, will quantify the impact of targeted Pre-Exposure Prophylaxis (PrEP) in the context of universal treatment and streamlined care. The study intervention is designed to improve the entire continuum of care, to reduce structural barriers for all populations including those most "at risk".

Eligibility Criteria:
Community Level Inclusion Criteria:

* Non-adjacent geopolitical units in south-western and eastern Uganda and western Kenya.
* Most recent census population between 9,000 and 11,000 individuals.
* Served by an ART providing health center.
* Community leader commitment for study participation and implementation.
* Accessibility to health center via a maintained transportation route.
* Community location with sufficient distance from other potential study communities to limit contamination of intervention or control conditions (buffer zone)

Individual Level Inclusion Criteria:

* Residency of individual in community, defined as present in household for at least 6 months of the calendar year.

Community Level Exclusion Criteria:

* Presence of ongoing community-based ART intervention strategies that provide treatment outside of the current in-country treatment guidelines.
* An urban setting defined as a city with a population of 100,000 or more inhabitants.
* Absence of a health center able to provide ART.
Trial of Adjuvant XELOX Chemotherapy and Concurrent Capecitabine and Radiotherapy for Resected Gastric Carcinoma

The objective of the trial is to compare disease-free survival between adjuvant XELOX alone vs XELOX with concurrent capecitabine and radiotherapy in curatively resected gastric cancer patients with D2 dissection.

Gastric cancer is one of the most common malignancies in China. Complete surgical resection is the only potentially curative therapy available to patients with gastric cancer. However, the overall survival results remain unsatisfactory. The main factor accounting for high mortality rate is the relapse after surgical resection. During the past few decades, the principle of combined modality treatment has been developed and applied in gastric cancer. Radiation therapy plus concurrent chemotherapy had demonstrated to be able to achieve a significant improvement in overall and disease-free survival according to Intergroup Trial 0116/Southwest Oncology Group 9008. Nevertheless, the result from Intergroup Trial 0116 study had been challenged by the fact that the surgical treatment applied in the trial was gastrectomy with limited lymph node dissection (D0 or D1) in 90% of cases. Therefore, it is debatable whether adjuvant chemoradiation therapy can confer survival benefit in patients with extensive lymph node dissection. In ARTIST study, the addition of concurrent capecitabine and radiotherapy to capecitabine and cisplatin chemotherapy did not significantly reduce recurrence after curative resection and D2 lymph node dissection in gastric cancer. In subgroup analysis of patients with positive pathologic lymphnodes, there was a statistically significant prolongation in disease-free survival in the concurrent treatment arm when compared with the chemotherapy alone arm. Furthermore, CLASSIC study showed that XELOX (oxaliplatin/capecitabine) combination given as adjuvant chemotherapy for stage II or III patients after D2 surgery could achieve a significant survival benefit. The standard treatment modality in gastric cancer after D2 dissection is still disputable. Thus, the assessment of the effect of adjuvant sequence chemoradiotherapy in D2 resected gastric cancer is essential.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven gastric cancer; ≥ D2 resection
* Stage T1-4, N+
* 18 ≤ age ≤ 75
* Eastern Cooperative Oncology Group 0-2
* No distant metastasis
* Adequate bone marrow functions (absolute neutrophil count≥ 1,500/ul, blood platelet≥ 100,000/ul, haemoglobin≥ 10g/dl)
* Adequate renal functions(serum creatinine ≤ 1.5mg/dl)
* Adequate liver functions (serum bilirubin ≤ 1.5mg/dl, aspartate aminotransferase/alanine aminotransferase ≤ 3 times(normal value)
* Written informed consent

Exclusion Criteria:

* Previous history of immunotherapy, chemotherapy, radiotherapy for gastric cancer;
* Active infection requiring antibiotics;
* Pregnant, lactating women;
* Psychiatric illness, epileptic disorders;
* Concurrent systemic illness not appropriate for chemotherapy;
* Resection margin (+);
* History of other malignancy within 5 years except for non-melanoma skin cancer, cervix in situ carcinoma;
* D0, D1 resection;
Effects of Virtual Reality Training for Stroke Patients

To examine the effects of using a virtual reality (VR) system to improve upper limb motor function among subacute hemiparetic stroke patients. Under this aim, the investigators have two objectives: (1) to develop and test a procedure for the quantitative assessment of stroke patients in a virtual environment; and (2) to compare the outcome measures of the two groups of stroke patients (VR-intervention vs. conventional-control) on these two modes of training.

After being informed about the study and potential risks, all participants who gave written consent will undergo the study. A randomized controlled trial with pre-/post-study, of 42 stroke patients with upper limb weakness (21 patients in the control group and 21 patients in the intervention group), 18-65 years old, all are newly admitted stroke patients in the rehabilitation clinic from one hospital. Participants in the intervention group will receive 60 minutes of VR training to improve upper limb function and daily living activities. Participants in the control group will receive 60 minutes of conventional training to improve upper limb function and daily living activities. The training includes grasp, grip, pinch, gross, and finger-hand coordination movement. The training will perform 5 times/week for 4 weeks. Two outcome measures: (a) The Barthel Index and (b) The Fugl-Meyer Assessment, time spent to complete a task were used to compare two groups.

Eligibility Criteria:
Inclusion Criteria:

1. New in-patients clinically diagnosed hemiparetic stroke patients;
2. Patients with a history of the first incidence of stroke with upper limb weakness with a motor impairment upper limbs as a primary deficit;
3. muscle strength \> 2/5 on the Medical Research Council (MRC) scale;
4. good cognitive ability as indicated by a score \> 15 on the Mini-Mental State Examination (MMSE); Motricity Index sore \> 26; and
5. ability to communicate and sign the consent.

Exclusion Criteria:

1. In-patient with ataxia or any other cerebellar symptoms;
2. orthopedic alterations or pain syndrome of the upper limb;
3. peripheral nerve damage affecting the upper extremities;
4. visual or hearing impairment (does not allow the possibility of interaction with the VR system);
5. severe hemispatial neglect;
6. severe shoulder or hand pain (unable to volitionally position the hand in the workspace without pain);
7. insensate forearm and /or hand, edema of the affected forearm and /or hand;
8. uncontrolled seizures disorder;
9. severe depression (\>13 on beck Depression inventory fast screen); and
10. severely impaired cognition or comprehension.