cyrilzakka/clinical-trials huggingface dataset:
Study of the Environmental Factors Modulating Children Immune Response in Northern Senegal

Longitudinal survey in Northern Senegal to investigate the environmental factors modulating the immune response to childhood vaccines and to malaria.

A cohort of 410 children aged 1 to 10 from 5 villages of the Senegal River Valley(Podor District) was followed-up for 18 months. During that period, 5 visits have been made to the villages to assess the immunological and nutritional status of the children.

Longitudinal survey in Northern Senegal to investigate the environmental factors modulating the immune response to childhood vaccines and to malaria.

A cohort of 410 children aged 1 to 10 from 5 villages of the Senegal River Valley(Podor District) was followed-up for 18 months. During that period, 5 visits have been made to the villages to assess the immunological and nutritional status of the children (T1 (October 2008), T2 (January 2009), T3 (June 2009), T4 (October 2009) and T5 (January 2010)).

The project was approved by the National Ethics Committee of Senegal. Written individual informed consent was obtained from each participant's parent or legal guardian at the beginning of the survey, and at each visit child's and parent's approval was sought orally.

Capillary blood was collected from the finger tip of each child, using sterile single-use material.

Body temperature was measured by means of auricular thermometer at all visits. Anthropomorphic data were collected at visits T2, T3, T4 and T5.

A Hemocue photometer (HemoCue AB, Ängelholm, Sweden) was used to determine haemoglobin concentration on a blood drop at visits T3, T4 and T5.

At each visit, a questionnaire was filled in for every child. Information was collected on the date of birth family membership to asses if siblings or children living in the same house were in the cohort.

Eligibility Criteria:
Inclusion Criteria:

* Age: between 1 and 10 years

Exclusion Criteria:

* Fever (body temperature superior to 38.5 °C)
Comparative Antimicrobial Efficacy of Two Topical Acne Therapies for the Treatment of Facial Acne

The purpose of the study is to determine the development of microbial resistance when using one of two topical acne therapies for the treatment of facial acne vulgaris.

To investigate the development of microbial resistance when using one of two topical acne therapies for the treatment of moderate to moderately severe facial acne vulgaris. Clinical efficacy and tolerability will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Outpatient at least 12 years of age. Female subjects of childbearing potential must have a negative urine pregnancy test result at baseline and practice a reliable method of contraception throughout the study.
* Mild to moderate facial acne vulgaris
* Able to understand the requirements of the study and sign informed consent/HIPAA authorization forms. Subjects under the legal age of consent in the state where the study is conducted must also have the written, informed consent of a parent or legal guardian.

Exclusion Criteria:

* Female subjects who are pregnant (positive urine pregnancy test), breast feeding or who are of childbearing potential and not practicing a reliable method of birth control
* Allergy or sensitivity to any component of the test medication
* Known hypersensitivity to to any component of the investigational formulations
* Known history of enteritis (regional enteritis, ulcerative colitis, pseudomembranous colitis, or antibiotic-associated colitis
* Beards or sideburns
* Skin disease/disorder that might interfere with the diagnosis or evaluation of acne vulgaris
* Evidence of recent alcohol or drug abuse
* Participation in an investigational drug study within 30 days of the baseline visit
Comparison of Two Naloxone Infusion Rates on the Postoperative Recovery of Patients Undergoing Spine Fusion Surgery

There will be two groups in this study: one group will be given the standard infusion of naloxone, a drug which helps reduce side effects from opioids needed after surgery, and the other group will receive a higher dose. The trial is designed to determine if a higher dose of naloxone infusion will reduce side effects from opioid therapy in patients who have undergone spine fusion for scoliosis.

Currently, patients undergoing spinal fusion for scoliosis are routinely given patient controlled analgesia (PCA) for pain control postoperatively. PCA therapy is typically combined with an ultra low dose naloxone infusion because of the established benefit of reduced pruritis and nausea. The investigators hypothesize that using a higher dose naloxone infusion may lead to further improvement in pruritis and nausea and may improve GI function. Improvement in bowel function could lead to faster initiation of oral intake as well as transition to oral pain medication and even decreased length of stay.

Eligibility Criteria:
Inclusion Criteria:

* Idiopathic scoliosis requiring spine fusion surgery
* Age 10-21 years

Exclusion Criteria:

* Inability to understand PCA instructions
* Allergy to: morphine, hydromorphone, fentanyl, naloxone, or diphenhydramine
* Chronic opioid therapy \> 2 months
* Non-English speaking
Effect of Bimekizumab in Patients With Psoriasis Vulgaris and Active Psoriatic Arthritis

This is an open-label study to evaluate the effects of bimekizumab in patients with psoriasis vulgaris and who also have active psoriatic arthritis (PsA).

This study is being conducted to evaluate the effects of bimekizumab administered subcutaneously (SC) to patients with psoriasis vulgaris and who also have active PsA who have an inadequate skin response to anti-interleukin (IL)23 therapy. Approximately 20 adult subjects with psoriasis vulgaris and active PsA who have an inadequate skin response to anti-IL23 will receive bimekizumab 320 mg solution administered SC every 4 weeks for 16 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female patient 18 years of age or older at the time of consent.
2. Patient with a history of psoriasis vulgaris and PsA (as determined by the investigator) for ≥ 6 months prior to the screening visit.
3. Patient with moderate-to-severe psoriasis vulgaris before initiating treatment with an anti-IL23 agent.
4. Patient with an inadequate skin response to at least 12 weeks treatment with an anti-IL23 agent for the treatment of psoriasis vulgaris as defined by a PGA ≥ 2 and plaque psoriasis covering ≥ 1% of total BSA (excluding palms and soles) at the screening and Day 1 visits.
5. Patient with active PsA as defined by ≥ 1 joint that is tender (TJC68) and/or swollen (SJC66) at Day 1.

Exclusion Criteria:

1. Female who is breastfeeding, pregnant, or who is planning to become pregnant during the study or within 4 months after the last study product administration.
2. Patient with evidence of erythrodermic, pustular, predominantly guttate psoriasis, or drug-induced psoriasis.
3. Patient with any known clinically significant medical condition or presence of a skin or rheumatologic disease that would, in the opinion of the investigator, put the patient at undue risk or interfere with the interpretation of study results.
4. Patient who plans to receive a live or live-attenuated vaccine during the study and up to 4 weeks or 5 half-lives (of the study product), whichever is longer, after the last study product administration.
5. Patient with an active infection (except common cold) that would place them at increased risk, a recent serious infection, or a history of opportunistic, recurrent, or chronic infections.
6. Patient with a diagnosis of inflammatory bowel disease (Crohn's disease or ulcerative colitis).
7. Patient with known or suspected hypersensitivity to bimekizumab or any component of the investigational product, including any nonmedicinal ingredient, or component of the container.
8. Patient who has received any marketed or investigational biological agent, except anti-IL23 agents, within 12 weeks or 5 half-lives (whichever is longer) prior to Day 1.
9. Patient who has received treatment with bimekizumab prior to Day 1.
Autologous CIK Cells Infusion for the Treatment of Lung Cancer: a Randomized Controlled Study

To study the efficacy and safety of autologous CIK cells infusion for the treatment of lung cancer.

A randomized controlled trail on the efficacy and safety of autologous cytokine-induced killer (CIK) cells infusion treatment in advanced primary lung cancer

Eligibility Criteria:
Inclusion Criteria:

* 18\~70 year old, KPS score \>50 points, estimate survival \> 3 months;
* Primary lung cancer patients after chemotherapy or radiation therapy;
* Primary lung cancer patients after targeted therapy;
* Primary lung cancer patients with lung function can not accept operation or unwilling to operation;
* Primary lung cancer recurrence or surgery can't complete resection;
* Primary lung cancer patients after intervention therapy(I125 implanted, freezing, rf, etc.);
* No serious mental illness and no serious heart, liver, kidney diseases, unincorporated other potentially lethal diseases;
* Patients Voluntary attempt, and informed consent.

Exclusion Criteria:

* History of cardiovascular disease: congestive heart failure \> New York heart association (NYHA) level II, unstable angina patients (resting when the angina symptoms) or new happen angina pectoris (recent 3 months) or recent 6 months of myocardial infarction;
* Cachexia; or other deadly diseases;
* Liver function laboratory ALT, AST more than normal limits on 2.0 times ; Or kidney TBIL, BUN more than normal limits on 1.0 times , or Cr more than normal upper limit;
* Active infection;
* Pregnant or lactating women
* At present Is receiving other cancer treatment (such as chemotherapy, radiation therapy, chemotherapy, immunosuppressants and thrombosis, targeted agents);
* Now or recently will join another experimental clinical study ;
* Other situations that the researchers considered unsuitable for this study (such as mental illness, drug abuse, HIV infections, etc.), or influence on the results of clinical trials for analysis.
Essilor® Stellest® Lenses Multicentre European Study (SLOMES)

The goal of this post-market clinical follow up Study is to demonstrate the efficacy, safety, acceptability, and quality of life implications of Essilor® Stellest® spectacle lenses in slowing myopia progression in European children and adolescents. Participants will receive Essilor® Stellest® at inclusion visit and will be asked for a full time wear (\>12 hours daily) for 24 months. The primary endpoints are the change in axial length and cycloplegic autorefraction from baseline to 24 months compared to expected change based on axial length and refraction centile positions at baseline.

The trial design is a multicentre, European, prospective, interventional study with single group assignment. The investigational medical device Essilor® Stellest® is a CE marked, myopia control spectacle lens. The trial period for all participants is 24 months. The recruiting period is 6 to 9 months depending on countries / sites for a total of 150 participants (50 in Ireland, 75 in France and 25 in The Netherlands).

The secondary objectives are:

* To evaluate the acceptability of Essilor® Stellest® spectacle lenses in slowing myopia progression.
* To evaluate the quality-of-life implications for children and adolescents.
* To evaluate the safety of Essilor® Stellest® spectacle lenses in slowing myopia progression.
* To evaluate the effect of Essilor® Stellest® spectacle lenses on choroidal thickness.

Eligibility Criteria:
Inclusion Criteria:

1. - Myopia as determined by cycloplegic autorefraction as follows:

   * Each meridian SER of plano to - 8;00 D in each eye
   * Astigmatism \< 2.50 D
   * Anisometropia ≤ 1.50 D
2. - Monocular corrected VA of at least 0.2 LogMAR in both eyes
3. - Age: 6 - 16 years old, inclusive at the time of inclusion
4. - Ability to understand treatment and give valid assent
5. - Ability to comply with the protocol to get reliable study measurements

Exclusion Criteria:

1. - Concomitant or previous therapies for myopia
2. - Eye diseases/conditions:

   * Strabismus by cover test at near or distance
   * Any ocular disease that would influence refractive development e.g. retinal disease, cataract, ptosis
   * Any systemic or neurodevelopmental conditions that may influence refractive development
3. - Use of ocular or systemic medication which may affect myopia progression or visual acuity through known effects on retina, accommodation, or significant elevation of intraocular pressure
4. - Participation in another study which may influence vision or interfere with study assessments
5. - Myopia onset before 5 years of age
6. - Contact lens wearers
A Psychological and Behavioral Intervention for Post-Bariatric Patients

The study is designed to test a pilot intervention for bariatric patients who are starting to regain weight after the 1st year post-surgery. Dialectical Behavior Therapy (DBT), an empirically supported therapy for Borderline Personality Disorder, has also successfully been applied to patients with substance use and binge eating problems. The purpose of this study is to develop and test a group intervention based on DBT and cognitive behavioral therapy (CBT) techniques for patients engaging in these maladaptive behaviors after surgery with co-occuring weight gain.

Weight regain post bariatric surgery may be due to anatomical, physiological, or psychological and behavioral factors. One potential psychological and behavioral contributor to poor weight loss outcome following bariatric surgery may be low distress tolerance, characterized by emotional reactivity to stressors and lack of appropriate emotional regulation, and using eating, drinking, or other substances to improve mood. Recent research indicates that a subset of patients post-surgery experience challenges with subjective bulimic episodes, graze eating, and alcohol misuse; evidence for poorer excess weight loss (EWL) outcomes is associated with graze eating and uncontrolled eating behavior. This submission is for a pilot project designed to examine the impact of participation in a dialectical behavior therapy (DBT) plus cognitive behavioral therapy intervention delivered post-surgery on weight, psychological, and behavioral outcomes after Roux-en-Y gastric bypass surgery (RYGB) for patients experiencing weight regain relapse with co-occuring disordered eating or substance misuse behaviors.

Eligibility Criteria:
Inclusion criteria

* regained ≥ 15% of total post-surgical weight lost
* has either disregulated eating, drinking, or misuse of chemical substance
* age 18-75
* ability to participate in group
* completed first Roux-en-Y gastric bypass procedure at Mayo Clinic

Exclusion criteria

* patients with an uncontrolled psychiatric diagnosis
* patients severely impaired by drug or alcohol use
* completed surgical intervention at location other than Mayo Clinic
* more than one bariatric procedure
A Real-World Study of Antiviral Therapy in Children With Chronic Hepatitis B

This is a multicenter, prospective, real-world study. The study plans to include a total of 2000 patients who meet the inclusion and exclusion criteria, consisting of 1600 treatment-naive patients and 400 treatment-experienced patients. The effectiveness and safety of different treatment strategies will be evaluated in children aged 1-12 years with treatment-naive and treatment-experienced chronic hepatitis B (CHB) and chronic HBV infection.


Eligibility Criteria:
Inclusion Criteria:

* Initial Treatment Group:

  1. The guardian understands and signs the informed consent form (both parents must sign), and adheres to the relevant requirements of this study. If the participant is 8 years old or older, they must also sign the informed consent form. For participants under 8 years old who can express consent, their consent must be clearly documented.
  2. Age: ≥1 year and \<13 years, either sex;
  3. Positive for HBsAg and/or HBV DNA for more than 6 months;
  4. No prior antiviral treatment.
* Treated Group:

  1. The guardian understands and signs the informed consent form (both parents must sign), and adheres to the relevant requirements of this study. If the participant is 8 years old or older, they must also sign the informed consent form. For participants under 8 years old who can express consent, their consent must be clearly documented.
  2. Age: ≥3 years and \<13 years, either sex;
  3. Previously diagnosed with chronic hepatitis B and received antiviral treatment with NAs for more than 1 year and currently on treatment;
  4. No history of IFNα use in the past 6 months;
  5. Negative for HBV DNA;
  6. HBsAg quantification \<10,000 IU/ml (HBsAg can be negative in the drug discontinuation observation group);
  7. The drug discontinuation observation group must also achieve negative HBV DNA and HBeAg seroconversion for at least 1 year (based on continuous results from three consecutive reviews), and HBsAg \<10,000 IU/ml; NAs will be discontinued after enrollment.

Exclusion Criteria:

* 1.In the interferon group, blood white blood cell count \<3.5×10\^9/L, or platelet count \<80×10\^9/L, or prothrombin activity \<60%, or total bilirubin \>34μmol/L, or serum albumin \<35g/L, or serum creatinine \>133μmol/L; 2.Coexistence of other active infections; 3. Coexistence of other chronic liver diseases or active liver diseases, such as autoimmune liver disease, drug-induced liver injury, Wilson's disease, decompensated cirrhosis, liver cancer; 4. Coexistence of other severe systemic diseases or malignant tumors, etc.; 5. History of allergy to nucleoside analogues or interferon; 6. Subjects whom the investigator deems to have poor compliance, unable or unwilling to provide informed consent, or unable to adhere to the study requirements, or other conditions not suitable for participation in this study.
System Biology of Spleen Deficiency Syndrome

Spleen Deficiency Syndrome(SDS)is a widely researched issue, but due to the limitations of the research methods, the scientific mechanism of SDS is biased and not comprehensive. SDS would be researched in this project deeply and systematically with modern life-scientific methods. Based on the previous work, the participants, with SDS, suffering from Qi deficiency syndrome--chronic superficial gastritis--chronic atrophic gastritis--gastric cancer would be included, and the corresponding research would be conducted at the molecular-cell-gastric tissue level, and at the same time, systematical biological database of SDS would be built by systematical biological methods, such as pioneered SPARS sequencing technology created in our research group, proteomics and metabonomics. Under the above work, the investigators would conduct data mining and molecular network analysis, and then verify the key functions. By analyzing the systematical biological features of syndrome and its relationships with constitution and disease, this study would provide a new basis for objective reality of syndrome, and also offer a crucial premise of revealing biological basis for syndrome correctly, which is of important theoretical and practical significance.


Eligibility Criteria:
Inclusion Criteria:

* Aged between 18 and 65 years.
* No apparent abnormality in the routine blood test, urinalysis, routine stool \& fecal occult blood test, biochemical test, chest radiograph and electrocardiogram(ECG).
* The endoscopic diagnoses of chronic superficial gastritis, chronic atrophic gastritis and gastric cancer conform to the corresponding pathological diagnoses
* TCM diagnoses of Spleen-qi Deficiency Syndrome or Spleen Damp-heat Syndrome.
* Voluntary participation.
* Having given written informed consent.

Exclusion Criteria:

* Gastropathy with special causes, such as acute gastritis, gastrinoma, chronic gastritis resulting from special causes (like granulomatous gastritis, lymphocytic gastritis, eosinophilic gastritis, gastritis after gastric operation) peptic ulcer, other malignant tumors of stomach (like gastric lymphoma, gastri stromal tumor, carcinoid tumor, malignant hemangioma, squamous-cell carcinoma, primary gastric choriocarcinoma and metastatic gastric tumor), benign gastritic tumors that originate from epithelium or submucosa (epithelial tumors like adenomatous polyps and hyperplastic polyps, stromal tumors like benign stromal tumor, neuronal tumor and pseudolymphoma).
* Combined with other digestive diseases (like gastroesophageal reflux, esophageal varices, acute and chronic hepatitis and cirrhosis arising from various causes, acute/chronic pancreatitis and acute/chronic cholecystitis).
* Combined with other severe systemic diseases such as respiratory failure, severe cardiovascular and cerebrovascular, immune system, urinary and mental disorders diseases.
* Pregnancy, or planning pregnancy during the trial or within three month period thereafter.
* Participation in any clinical trial including blood sampling and/or administration of substances up to 90 days before Day 01 of this study.
Visual Attention and Eye Movements

The purpose of this study is to provide information about how the brain processes sensory inputs using visual stimuli throughout various psychophysical experiments.

This laboratory studies visual perception with a focus on the interaction between eye movements and attention. It is well established that attending to a stimulus can profoundly alter perception. For example, attending to a speaker at a crowded party can almost completely filter background both in terms of auditory noise and visual distractions. Although laboratory studies have traditionally investigated the effects of attentional changes in the absence of eye movements, under natural conditions, visual attention is often accompanied by orienting movements to direct our head and eyes towards the relevant objects of interest. Recent work has suggested that these orienting movements affect perception in a manner similar to covert attention. The proposed studies will investigate how eye movements contribute to perception and attention.

The research covered by this protocol combines traditional "button-press" psychophysics with non-invasive eye-tracking to investigate the interaction between eye movements and perception. Subjects will perform simple perceptual tasks, such as judging the orientation or direction of a visual stimulus, while their eye position is monitored with a video eye-tracker. This approach (combining psychophysics and eye-tracking) is flexible, low risk, and fast when compared with neurophysiological studies. However, by focusing on low-level perceptual tasks, the results will be interpretable in the context of larger studies of neurophysiological responses in the visual system.

The investigators hope that this basic research will ultimately have both applied and clinical significance. For example, understanding how perception is influenced by attention and eye-movements in neurotypical populations may provide non-invasive and naturalistic ways to identify and diagnose psychiatric disorders. Additionally, understanding how eye-movements interact with sensory encoding has the potential to improve machine learning algorithms for vision and navigation (These are not a part of the current study, but a potential future impact).

Eligibility Criteria:
Inclusion Criteria:

* Age between 18-65
* Corrected-to-normal vision
* No known diagnosis of visual or auditory disorder or impairment

Exclusion Criteria:

* Does not have corrected-to-normal vision
* Unable to understand and follow the instructions given of the study
* Known diagnosis of visual or auditory disorder or impairment
Engaging Black Men in Colorectal Cancer Screening

To determine the unmet needs, attitudes, barriers and facilitators of African American (AA)/ Black men use of colorectal cancer screening and describe how community leaders such as barbers may act as Community Champions to educate and facilitate screening participation.


Eligibility Criteria:
Inclusion Criteria:

* Adult men
* Identify as Black or African American
* Work or live in Petersburg, VA or surrounding counties
* Eligible for colorectal cancer (CRC) screening at time of study enrollment

Exclusion Criteria:

* Inability to speak or read English
* Currently up-to-date with CRC screening