cyrilzakka/clinical-trials huggingface dataset:
Interpersonal Relationships Intervention and Cardiovascular Health

The purpose of this study is to determine whether random assignment to a mentor-mentee relationship is associated with beneficial cardiovascular health effects in both mentors and mentees.

Participants will be undergraduate students randomly assigned to either being in the mentor or comparison group. A second set of participants will be randomly assigned to either being in the mentee or comparison group. These participants will come from Chicago Public School elementary schools. In total, there will be 125 mentors, 125 comparators, 125 mentees, and 125 comparators. Participants will come for a laboratory visit in which cardiovascular health measures will be taken (details below). Visits will occur once at baseline (before the intervention starts), and once post-intervention. There will be a mid-point assessment of questionnaires. Participants in the intervention group will engage in one-on-one mentoring sessions (mentors together with mentees) once a week after school for the school year. Participants in the comparator group will receive written versions of all materials covered in the mentoring sessions.

Eligibility Criteria:
Inclusion Criteria:

* undergraduate students for mentors
* Chicago Public School students for mentees

Exclusion Criteria:

-
Vagus Nerve Injury Post Radiofrequency Catheter Ablation for Atrial Fibrillation

This study is an observational study designed to determine the extent of gastrointestinal (GI) post-procedure complications after Radiofrequency Catheter Ablation (RFCA) for atrial fibrillation (AF). This exploratory study will evaluate patient symptoms prior to the RFCA procedure, at 1 month post RFCA procedure, and at 3 months post RFCA procedure, through the administration of a questionnaire. The purpose of this study is to determine if vagus nerve injury resulting from RFCA for AF increases the risk of post-procedure GI complications that may present as temporary or permanent symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a verified medical history of atrial fibrillation.
* Male or female \>18 years of age.
* Patients scheduled for an RFCA procedure, subsequent to failure of one Antiarrhythmic Drug (AAD class I, III or IV), or ablation.
* Ability to answer questions posed by the questionnaire.
* Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of any study procedures.

Exclusion Criteria:

* None
Clinical Trial for Evaluation of Ethnic Differences in Pharmacokinetics of Chloroquine, an Anti-malarial Drug

Chloroquine is an anti-malaria agent. This study is designed to evaluate inter-ethnic differences of therapeutic effect of chloroquine and search the cause of these ethnic differences. For this purpose, chloroquine will be administered to four ethic groups of Korean, Caucasian, African and Southeast Asian and chloroquine concentration in blood will be measured. The result of this study will be helpful in finding more adequate dosing regimen of chloroquine in patients with malaria.


Eligibility Criteria:
Inclusion Criteria:

* aged 20 - 50 male subjects (6 Koreans, 6 Caucasians, 6 Africans and 6 Southeast Asians)
* Subjects with body weight ≥ 45 kg and within ±20% of the ideal body weight : Ideal body weight = (height \[cm\] - 100)x0.9.

Exclusion Criteria:

* Subjects who have drunken habitually (exceeding 21 units/week, 1 unit = 10 g of pure alcohol) or who are unable to abstain from drinking during the study period from 2 days prior to the first administration of investigational product and during this study.
* Subjects deemed ineligible by investigator based on other reasons, including abnormal laboratory values or diseases.
Relationship Between Contact Point to Attachment Level and Presence of Interdental Papilla

Thorough search of literature revealed no study has correlated the presence/absence of papilla to the contact point to attachment level distance. It could be a non- invasive approach and there is no need to inject local anaesthesia to the patient. It might be beneficial in predicting the papilla reconstruction outcome in patient friendly and non-invasive way.

The presence of interdental papilla specially of maxillary anterior tooth region is an essential esthetic component. Loss of papilla or black triangle is not appealing and it is concern for both patient and clinicians. Beside esthetic concern, black triangle is associated with phonetic problem and food impaction. Several factors which may influence the presence/absence of interdental papilla are alveolar bone height, gingival biotype, interdental space morphology, type of contact area. Different classification system to categorize interdental papilla loss have been proposed. In the landmark study by Tarnow, a correlation was found between vertical distance from contact point to bone crest and presence/ absence of interdental papilla. Interdental clinical attachment level may indirectly indicate the changes in underlying bone level and it has been proven to be an important prognostic factor in consideration of success of root coverage procedure. Thorough search of literature revealed no study has correlated the presence/absence of papilla to the contact point to attachment level distance. It could be a non- invasive approach and there is no need to inject local anaesthesia to the patient. It might be beneficial in predicting the papilla reconstruction outcome in patient friendly and non-invasive way.

Eligibility Criteria:
Inclusion Criteria:

* Intact maxillary central incisors
* Age 18-50 years
* Closed contact points
* No history of traumatic tooth injury
* Completion of cause related therapy before 3months
* Full mouth plaque score and full mouth bleeding score \<15%

Exclusion Criteria:

* • Systemic ailments which affect periodontium

  * History of previous periodontal surgery
  * Tooth with a prosthetic crown or restoration involving cementoenamel junction (CEJ).
  * Pathologic tooth migration
  * Presence of cervical abrasion/erosions
  * Presence of dental caries in maxillary central incisors
  * Trauma from occlusion
  * Crowding or spacing in maxillary central incisors
  * Angular bone defects
  * Pregnant women
  * Mobile tooth
Gel-200 Versus Placebo in Osteoarthritis of the Knee

The purpose of this study is to determine if a single intra-articular injection of Gel-200 is superior to a single injection of Phosphate Buffered Saline (PBS) in subjects with symptomatic osteoarthritis of the knee.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with a diagnosis of painful, symptomatic tibio-femoral osteoarthritis of the knee (Grade 1-3 on Kellgren - Lawrence (K-L) score).

Exclusion Criteria:

* Subjects with Grade 4 on K-L score
* Subjects with inflammatory diseases of the knee other than osteoarthritis such as rheumatoid arthritis
* Serious systemic diseases
* Female subjects who are pregnant or lactating
Trimethylamine N-oxide in Myocardial Infarction

Trimethylamine-N-oxide (TMAO) is produced from the metabolism of gut microbiota and is reportedly pro-atherogenic and associated with cardiovascular events. The purpose of this study is to investigate the sequential change in TMAO levels by current optimal secondary prevention therapies in patients with ST-elevation acute myocardial infarction (STEMI) and the clinical impact of TMAO levels on the progression of atherosclerosis and subsequent cardiovascular events.

This study includes patients with their first STEMI. The investigators measure plasma TMAO levels using the frozen plasma at the onset of STEMI and 10 months later (the chronic phase). To assess plaque progression, residual SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) score and chronic-phase SYNTAX score are measured. After the chronic-phase assessment of TMAO and SYNTAX score, patients are followed for cardiovascular events including death, myocardial infarction, ischemic stroke, and unstable angina pectoris with coronary revascularization.

Eligibility Criteria:
Inclusion Criteria:

* Patients who admitted to the Yokohama City University Medical Center with the diagnosis of their first STEMI and who underwent primary percutaneous coronary intervention within 12 hours after onset and received follow-up coronary angiogram 10 months after the index intervention.

Exclusion Criteria:

* none
Epidemiology of Septic Shock in Medical or Polyvalent ICU in the North-East Region of France

The epidemiology of this study aims and outcome of patients with septic shock in the intensive care unit (or versatile) of the North-East region in france as well as the modalities of care.


Eligibility Criteria:
Inclusion Criteria:

* Patients in septic shock defined by hypotension that is not reversed by volume resuscitation and requires the use of vasopressors.

Exclusion Criteria:

* None
Role of Propolis Endodontic Irrigant on Post-Operative Pain

The goal of this clinical trial is to compare propolis and sodium hypochlorite as endodontic irrigants in patients presenting with symptomatic irreversible pulpitis.

. The main question it aims to answer is:

• if there is any analgesic effects of 20% Propolis compared with 5.25% NaOCl on the intensity of post-operative pain in patients with symptomatic irreversible pulpitis using VAS pain score. Participants will undergo root canal treatment of their teeth using either 20% propolis solution or 5.25% NaOCl in their first visit of a multi-visit root canal treatment.

Researchers will compare 20% Propolis and 5.25% NaOCl to see reduction in Intensity of Post-Operative Pain using visual analogue scale over 72 hour duration.

Sodium hypochlorite as an endodontic irrigant, poses problems of toxicity. Additionally, its unfavorable odor, taste, failure to remove the smear layer, and proteolytic effect have deleterious effects on the dentine, creating unfavorable structural and mechanical alterations . To get beyond NaOCl limits and adverse effects, it is necessary to look for a biocompatible, equally effective, and dentine friendly irrigant with greater patient acceptance in taste and odor.

The literature lacks an in-vivo study that investigates the anti-inflammatory with analgesic characteristics of Propolis on post-endodontic pain as an irrigant, in patients with symptomatic irreversible pulpitis. This research will endeavor to fill this gap in literature.

Eligibility Criteria:
Inclusion Criteria:

1. ASA-I and II individuals who are between the ages of 18 and 60 years.
2. Patients with mandibular and maxillary premolars who have been diagnosed with symptomatic irreversible pulpitis (with either a normal periapex or symptomatic apical periodontitis).
3. Patients who score moderate to severe (4-10) on a preoperative visual analogue scale (VAS=1-10)

Exclusion Criteria:

1. Patients suffering from severe pain because of traumatic occlusion.
2. Teeth with extensive damage, calcified canals, periapical radiolucency, root resorption, and an open apex.
3. Patients with compromised medical condition (ASA-III and above)
4. Patients who are unable to communicate effectively in either Urdu or English.
5. Pregnant and lactating ladies
6. Patients who are allergic to honey or bee pollen.
Camrelizumab for Patients with Recurrent Primary Central Nervous System Lymphoma (PCNSL)

This study is intend to improve the objective response rate in treatment of camrelizumab in recurrent primary central nervous system lymphoma patients.

Primary CNS lymphoma (PCNSL) is a rare B-cell variant of non-Hodgkin lymphoma that is confined to the brain, leptomeninges, spinal cord, and eyes. The optimum treatment for patients with recurrent PCNSL remains challenging and at present there is no universally accepted therapeutic approach . The purpose of this study is to evaluate the efficacy and safety of camrelizumab \[a programmed cell death 1 (PD-1) inhibitor\] for recurrent patients with primary CNS lymphoma.

Eligibility Criteria:
Inclusion Criteria:

1. The initial diagnosis was primary diffuse large B-cell lymphoma of the central nervous system confirmed by histopathology;
2. Prior to first-line treatment based on methotrexate (with or without radiotherapy), tumor recurrence was confirmed by MRI;
3. Measurable focus in MRI (\>10x10mm);
4. Aged \> 18 years;
5. Life expectancy of at least 12 weeks;
6. The patient has a Karnofsky performance status of at least 50%;
7. Main organs function normally, without serious blood, heart, lung, liver, kidney and immune deficiency diseases. Specific assay indicators requirements： White blood cells\>3.0×10\^9/L;platelet\>80×10\^9/L;hemoglobin\>10g/dL;serum bilirubin ≤ 1.5×ULN;ALT and AST ≤ 2×ULN;serum creatinine≤1.5mg/dL;
8. Female subjects of childbearing age must exclude pregnancy and are willing to use a medically approved high-efficiency contraceptive (eg, IUD, contraceptive or condom) during the study period and within 3 months of the last study drug administration;
9. The subject should be aware of the purpose of the study and the operations required by the study and volunteer to participate in the study before sign the informed consent form;

Exclusion Criteria:

1. Concurrent administration of any other antitumor therapy；
2. Allergic to the ingredients of research drugs；
3. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent；
4. Any active autoimmune diseases or a history of autoimmune diseases (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, decreased thyroid function；
5. Systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment, except for a maximum dose of 4 mg/day dexamethasone or equivalent doses of other corticosteroids or control of brain edema, which has been stable or decreased for at least 1 week prior to inclusion;
6. Active infection;
7. Risk of bleeding;
8. HIV positivity;
9. Pregnancy and lactation;
Programmed Intermittent Epidural Bolus For Laboring Obstetrical Women

Comparison of three programmed intermittent epidural bolus (PIEB) pump settings for maintenance of labour analgesia.

The optimal PIEB and patient controlled epidural administered (PCEA) bolus settings are still unknown. Therefore, in this study, the investigators aim to compare analgesia outcomes both high and low PIEB flow rate settings.

Eligibility Criteria:
Inclusion Criteria:

* Singleton, vertex presentations at term (37-42 weeks gestational age)
* \</= 5cm cervical dilation at the time of epidural anesthesia request
* ASA 2-3 patients aged 19 or over who are able to provide informed consent

Exclusion Criteria:

* Contraindications to neuraxial analgesia or risk factors likely to affect placement or function of the epidural
* History of hypersensitivity or idiosyncratic reaction to local anesthetics or opioids
* Current or historical evidence of any significant medical conditions
* Clinical settings in which continuous epidural infusion may be preferable
* Risk factors significantly increasing the need for Cesarean delivery
* Anticipated fetal abnormalities
Golimumab Utilization and Impact on Ulcerative Colitis (MK-8259-032)

The primary objective of this study is to evaluate the efficacy of golimumab in maintaining a clinical response in participants with moderate-to-severe ulcerative colitis.

This study consists of a 1 week screening period, a 54 week treatment period, and a 12 week follow-up period, requiring a total of 7 trial site visits: Visit 1(screening visit, Week -1), Visit 2 (enrollment visit, Day 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 5 (Week 30) and Visit 6 (Week 54) and Visit 7 (follow-up visit, Week 66).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of ulcerative colitis for at least 3 months with moderate-to-severe disease at enrollment.
* Has a rectal bleeding subscore of 1 or more at baseline.
* No evidence of active, or latent, or inadequately treated infection with Mycobacterium tuberculosis (TB).
* Must be eligible to start golimumab treatment according to the summary of product characteristics.
* Must be naïve to anti-tumor necrosis factor (anti-TNF) therapy.
* Women of childbearing potential or men capable of fathering children must agree to use adequate birth control measures (eg, abstinence, oral contraceptives, intrauterine device, barrier method with spermicide, implant, surgical sterilization).
* Women of childbearing potential must test negative for pregnancy at screening.
* Any prior azathioprine / 6-mercaptopurine use was initiated at least 12 weeks prior to enrollment with either stable dosing or discontinued treatment for the 4 weeks immediately prior to enrollment.

Exclusion Criteria:

* Clinical signs of ischaemic colitis, fulminant colitis or toxic megacolon.
* Has evidence of pathogenic bowel infection.
* Has a diagnosis of indeterminate colitis, or clinical findings suggestive of Crohn's disease.
* Has had surgery as a treatment for ulcerative colitis, or is likely to require surgery.
* Has ulcerative colitis which is confined to a proctitis (distal 15 cm or less).
* Has a current or recent history of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiac, or neurological disease.
* Has a current immunization with any live virus vaccine or history of immunization with any live virus vaccine within 3 months of baseline.
* Pregnant or lactating, or planning pregnancy while enrolled in the study.
* Has received agents that deplete B or T cells (eg, rituximab or alemtuzumab) within 12 months prior to study inclusion, or continue to manifest depletion of B or T cells more than 12 months after completion of therapy with lymphocyte-depleting agents.
* Has received cyclosporine, tacrolimus, sirolimus, or mycophenolate mofetil (MMF) within 8 weeks prior to study inclusion.
* Has used any investigational drugs within 30 days of Screening.
* Has a known hypersensitivity to human immunoglobulin proteins or other components of golimumab.
* Has received methotrexate within 12 weeks prior to enrollment
* Has received rectal corticosteroids or rectal 5-aminosalicylic acid (5-ASA) compounds within 2 weeks prior to enrollment (may be commenced if required after Week 6 in the study)
Preference for Clarinex Tablets vs. Allegra Tablets in Patients With Seasonal Allergies (Study P03177)

This was a crossover study designed to see if patients with seasonal allergy symptoms preferred Clarinex® or Allegra®. Patients were randomized to take 7 days of Clarinex or Allegra treatment, followed by a 5 to 28-day washout period (days when no drug is given), followed by 7 days of the opposite treatment. At the end of each 7-day treatment, patients were asked questions to determine which drug, Clarinex or Allegra, the patient prefers more.


Eligibility Criteria:
Inclusion Criteria:

* had at least a two-year history of seasonal allergic rhinitis;
* currently experiencing symptoms of SAR, including nasal symptoms at Visits 2 and 4, prior to entering each treatment phase;
* had not taken Allegra® or Clarinex® within the previous year;
* were 18 years of age or older;
* had negative urine test (hCG) for females of childbearing potential;
* for women of childbearing potential, agreed to use a medically accepted method of birth control;
* were free of any clinically significant disease (other than SAR) that would interfere with study evaluations;

Exclusion Criteria:

* were pregnant or nursing;
* had allergic or idiosyncratic reaction to antihistamines;
* had current or history of frequent, clinically significant sinusitis or chronic purulent nasal discharge;
* had rhinitis medicamentosa or nasal structural abnormalities (including large nasal polyps and marked septal deviation) that significantly interfered with nasal airflow;
* in the opinion of the Investigator, were dependent upon nasal, oral or ocular decongestants, nasal topical antihistamines, or nasal steroids (ie., subjects who could or would not observe the washout period for these prohibited medications);
* had an upper respiratory tract or sinus infection that required antibiotic therapy with the last dose within 14 days prior to Screening, or had a viral upper respiratory infection within 7 days prior to Screening;
* had asthma, unless their symptoms could be controlled by a short-acting inhaled Beta2-agonist used on an "as needed" basis;
* were on immunotherapy, unless they were on a stable maintenance schedule prior to screening. The dose of immunotherapy should remain constant and subjects could not receive immunotherapy within 24 hours prior to any visit;
* had a history of psychosis, antagonistic personality, poor motivation, hypochondriasis, or any other emotional or intellectual problems that were likely to limit the validity of consent to participate in the study;
* had a history of non-compliance with medications or treatment protocols;
* had any clinically significant deviation from normal in the physical examination that, in the Investigator's judgment, may have interfered with the study evaluations or affect subject safety;
* had any clinically significant metabolic, cardiovascular, immunologic, neurologic, hematologic, gastrointestinal, cerebrovascular, or respiratory disease, or any other disorder which, in the judgment of the Investigator, might interfere with the study evaluations or affect subject safety;
* had liver or renal impairment.
A Clinical Investigation to Evaluate the Safety and Performance of a Treatment Kit for Ingrowing Toenail

This purpose of this study is to evaluate the safety and performance of a treatment kit for ingrowing toenail, primarily by determining the number of subjects who show a reduction in the severity of their ingrowing toenail.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with one great ingrowing toenail that is rated as either "slightly ingrowing", "somewhat ingrowing" or "very ingrowing" on the Investigators Ingrowing Toenail Severity Scale.
* Subjects whose worst pain experienced in the week preceding inclusion, is rated at least 3 on the 10 point Subject Pain Intensity Scale.
* Subjects whose affected toenail has a minimum of 2mm distal edge and a minimum nail width of at least 16mm.

Exclusion Criteria:

* Subjects with any other toenail pathology (including pincer and spicule toenail) that would compromise the fitting of the toenail clip, or its use.
* Subjects suspected to be immunocompromised.
* Subjects who suffer from impaired feeling in the feet due to diabetes, peripheral vascular disease or neuropathy.
* Subjects with any cutaneous pathology or cuts/abrasions which, in the opinion of the investigator, could compromise safety or affect the outcome of the clinical investigation (for example, interfere with assessments).
* Subjects with known sensitivity/allergies to any component of the investigational device.
* Significant current or past medical history of hepatic, renal, cardiac, pulmonary, digestive, haematological, neurological, locomotor or psychiatric disease, which, in the opinion of the Investigator, would compromise the safety of the subject or affect the outcome of the clinical investigation (as determined from self-reported medical history questionnaire).
* Use of concomitant medication likely to affect the response to the investigational device or confuse the results of the clinical investigation. Regular pain relief is not permitted and subjects must not take any analgesics in the 24 hours preceding any clinic visit.
* Female subjects of childbearing potential who, for the duration of the study, are either unwilling or unable to take adequate contraceptive precautions or are unwilling to be sexually abstinent.
* Pregnancy or lactating mother.