cyrilzakka/clinical-trials huggingface dataset:
Primary Cervical Cancer Screening by Self-sampling HPV Test

Cervical cancer seriously threatens women's health and HPV infection is the main cause of cervical cancer. Traditionally, Cervical cancer screening is based on cervical exfoliated cell samples collected by health care provider, which is labor consuming and the coverage and compliance are both relatively low in some areas. Non-invasive hrHPV self-sampling test appears to be more acceptable and may improve the HPV screening coverage. This study aims to evaluate the clinical performance of a newly developed urine/vaginal self-sampling hrHPV test in Cervical cancer screening.

This study is a prospective multi-center clinical trial in China. Eligible participants are cervical cancer screening population who meet the enrollment criterias. All the participants are required to provide urine and vaginal samples by self-sampling, as well as the cervical exfoliated cell samples (by HCP). Participants may undergo colposcopy examination depending on the test results, and they will be followed up for three years.

The high-risk human papillomavirus nucleic acid detection kit (PCR-fluorescent probe method) developed by New Horizon Co., Ltd . is suitable for in vitro qualitative detection of 14 types of high-risk HPV ( 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68) nucleic acid.

The clinical performance of the self-sampling test will be assessed base on the following outcomes:

1. The sensitivity for detecting CIN2+
2. The specificity in non-CIN2+ population
3. The risk of developing CIN2+ in test positive cohort and test negative cohort
4. The accuracy of detecting hrHPV

Eligibility Criteria:
Inclusion Criteria:

* a. Females aged 21-65; b. have a history of sexual life; c. The patients were voluntarily enrolled and signed the informed consent.

Exclusion Criteria:

* Accuracy Verification:

Subjects meeting any of the following criteria will be excluded:

1. Known pregnant subjects.
2. Participants who have undergone total hysterectomy.
3. Participants who have received cervical resection therapy or ablative therapy within 12 months, such as cryo, laser, microwave, coagulation, cryotherapy, LEEP, large loop electrosurgery (LLETZ), cold knife conization (CKC), laser conization, or ablation.
4. Participants with poor compliance or researchers who believe that they are not suitable to participate in this study.

   * Primary screening use:

Subjects meeting any of the following criteria will be excluded:

1. Known pregnant subjects.
2. Participants who have undergone total hysterectomy.
3. Participants who have received cervical resection therapy or ablative therapy within 12 months, such as cryo, laser, microwave, coagulation, cryotherapy, LEEP, large loop electrosurgery (LLETZ), cold knife conization (CKC), laser conization, or ablation.
4. Those with known history of cervical cancer.
5. Participants who participated in cervical cancer screening programs or underwent cervical cytology within 12 months.
6. Participants with poor compliance or researchers who believe that they are not suitable to participate in this study.
Feasibility of Self-treatment of Painful Diabetic Neuropathy Using Electrical Vasomotor Nerve Stimulation

Electrical stimulation with EVNS (Electrical Vasomotor Neuro Stimulation), a methodology used by a specific group of neurostimulators known under various names, has proven its benefit in Painful Diabetic Neuropathy (PDN). However, due to the impaired mobility from Diabetic Neuropathy, a part of subjects did not finish the 10 days treatment in the outpatient clinic. Another part of the target group decided not to participate at all for the same reason.

The current study investigates the feasibility, safety and performance of a newly developed EVNS device, called Releaf™, optimised for HOME treatment,


Eligibility Criteria:
Inclusion Criteria:

* Painful Diabetic Neuropathy (DN4 positive) and insufficiently treated with any combination of 2 of the following drugs: Duloxetine (Cymbalta), venlafaxine (Efexor), ami- or nortriptyline, gabapentine, pregabaline (Lyrica) or the use of carbamazepine or capsaïcine (Qutenza).
* Both feet are present
* Able and willing to complete the treatments in 10 days in a row and completion of questionnaires.
* Being in a mental and physical state to perform home self-treatment with Releaf™ for 10 consecutive days, if necessary with adequate assistance of caregiver.
* Being in a mental and physical state to understand and complete the informed consent form as well as the research questionnaires.

Exclusion Criteria:

* In case of other evident causes for painful neuropathy,
* Currently participating in another interventional investigational study
* Significant peripheral arterial disease,
* Active foot ulceration or other skin conditions that prevent the application of electrodes on the skin
* Current alcohol or other substance abuse (use of alcohol over the recommended limits of less than 21 units of alcohol per week in men and 14 units in women, Trimbos Intitute),
* Epilepsy,
* Pregnancy,
* Presence of a medical device based on electrical stimulation, cardiac pacemaker and/or implantable cardioverter defibrillator or any other active implant
* Allergy to electrode contact area or to the adhesive substance of the electrode.
Safety Study for Bepotastine Besilate Ophthalmic Solution in Normal Volunteers

Safety study for bepotastine besilate ophthalmic solution in normal volunteers


Eligibility Criteria:
Inclusion Criteria:

* Subjects must be at least 3 years of age, and have ocular health within normal limits

Exclusion Criteria:

* No active ocular disease
Study to Evaluate the Efficacy and Safety of "Allergovac Poliplus" in Polysensitized Patients With Allergic Rhinitis/Rhinoconjunctivitis, With or Without Asthma

This is an observational prospective multicenter clinical study, to evaluate the efficacy and safety of the treatment with Allergovac Poliplus subcutaneous immunotherapy (SCIT) with a mixture of 2 allergenic extracts (pollens or mites), in polymerized-depot formulation, administered in its different available allergenic extracts mixtures (2 pollens or 2 mites), and in one of the 2 recommended administration schedules (1 Day or Rapid).


Eligibility Criteria:
Inclusion Criteria:

1. Patients aged between 5 and 60 years with allergic rhinitis or rhinoconjunctivitis mediated by IgE, caused by sensitization to more than one allergenic source (pollens or mites) and with or without associated mild / moderate asthma.
2. Patients susceptible to receive treatment with Allergovac Poliplus (SCIT), according to usual clinical practice
3. Patients who have given their signed informed consent.

Exclusion Criteria:

1. Patients who have received or initiated treatment with Allergovac Poliplus previously to study inclusion.
2. Patients who have received previous immunotherapy treatment, both subcutaneous (SCIT) and sublingual (SLIT), with any of the allergenic extracts that they plan to receive, in the 5 years prior to study inclusion.
3. Patients who in the opinion of the investigator may present difficulties that prevent the understanding of what was written in the informed consent form or the completion of self-administered questionnaires / scales or the patient's diary.
4. Patients who are participating in another clinical trial or observational study with any drug.
Trial of Decitabine in Patients With Acute Myeloid Leukemia

The purpose of this study is to compare the results in older patients who have newly diagnosed or secondary acute myeloid leukemia (AML) and who are to either receive decitabine or patient's choice with the physician's advice of either cytarabine or supportive care medication.


Eligibility Criteria:
Inclusion Criteria:

1. Must have diagnosed acute myeloid leukemia.
2. Must have a life expectancy of at least 12 weeks.
3. Must sign informed consent.

Exclusion Criteria:

1. Must not have acute promyelocytic leukemia (M3 classification)
2. Must not have any other active systemic malignancies.
3. Must not have inaspirable bone marrow.
4. Must not have received previous chemotherapy (except hydroxyurea) for any myeloid disorder.
5. Must not have chronic respiratory disease that requires continuous oxygen use.
6. Must not have received any experimental drug within 4 weeks before randomization.
7. Must not be a candidate for a bone marrow or stem cell transplant within 12 weeks after randomization.
8. Must not have known HIV.
My Health Day by Day (Mi Salud Dia a Dia)

The purpose of this study is to is to evaluate how Cognitive Behavioral Stress Management (CBSM) targets (e.g., anxiety reduction, cognitive reappraisal, coping, emotional expression, communication skills, social support) operate through Science of Behavior Change (SOBC) measures and influence dyadic adjustment and Health Related Quality of Life (HRQoL) in Prostate Cancer (PC) survivors and spouses/partners, in addition to physiologic adaptation and symptom burden in PC survivors.


Eligibility Criteria:
Inclusion Criteria:

Prostate Cancer Survivor

1. ≥18 years of age
2. Hispanic/Latino self- identification
3. Spanish speakers (including bilinguals who agree to participate in a Spanish intervention)
4. primary diagnosis of localized PC (T1-T3, N0, M0)
5. surgical or radiation treatment in the past 4-months
6. no history of non-skin cancer for the past 2 years
7. no psychiatric treatment or overt signs of severe psychopathology (e.g., psychosis, substance dependence)
8. owning a smartphone device with an Android or iPhone Operating System (iOS), which is necessary to collect the proposed Ecological Momentary Assessment (EMA) data or a valid email address.

(I) willingness to wear the E4 wristband at 5 time points, over the course of 4 days (J) has a spouse/partner that is willing to participate or is willing to participate in the study alone

Spouses/Partners:

1. female or male ≥18 years of age
2. have no history of inpatient psychiatric treatment for severe mental illness or overt signs of severe psychopathology (e.g., psychosis, substance dep., dementia)
3. willingness to be assessed and followed for 6 months
4. no life-threatening illness with a life expectancy \< 12 months
5. identifies as a spouse/partner and is willing to participate in the study.

Exclusion Criteria:

* Not meeting all of the inclusion criteria
A Clinical Trial of Mycobacterium w in Critically Ill COVID 19 Patients

The trial is randomized, blinded, two arms, active comparator controlled, clinical trial to evaluate the safety and efficacy of Mycobacterium w in combination with standard care as per hospital practice versus standard care alone in critically ill adult patients suffering from COVID-19 infection.

In this study, Eligible patients will be enrolled after due consent and will be randomized in balance to receive either test drug (along with the standard of care) or Placebo (along with the standard of care). The enrolled patients will be monitored for any adverse events (AEs) or serious adverse events (SAEs) throughout the study period. All patients will continue to receive standard therapy till considered requisite by the treating physician.

In addition to the standard care for COVID-19, patients randomized to test arm will receive single daily dose of 0.3 ml of Mw, intradermal, for 3 consecutive days while patients randomized to control arm will receive single daily dose of 0.3 ml of Placebo, intradermal, for 3 consecutive days.

Study duration for each patient will be upto 28 days post-randomization.

Eligibility Criteria:
Inclusion Criteria:

* Critically ill patients infected with COVID-19 (clinical/confirmed)
* Patient aged 18 years or more of either gender
* Illness of any duration with respiratory rate ≥25 breaths/minute, and at least one of the following:

  * Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.), or or
  * SpO2 ≤94% on room air, or
  * Requiring mechanical ventilation and/or supplemental oxygen
* Female patients of childbearing potential must have a negative pregnancy test within 14 days prior to first dose of study medication.
* Subject (or legally authorized representative) provides written informed consent prior to initiation of any study procedure.

Exclusion Criteria:

* Pregnant or nursing female.
* Patients with history of allergy, hypersensitivity, or any serious reaction to study medication
* Patients with a concomitant medical condition, whose participation, in the opinion of the investigator, may create an unacceptable additional risk.
* Patient previously enrolled into this study.
* Patient participating or having participated in a clinical trial with another investigational drug within the last 28 days except for investigational drugs against cancer, leukaemia or HIV.
* Patients with a life expectancy judged to be less than five days
* ALT/AST \> 5 times the upper limit of normal
* Stage 4 severe chronic kidney disease or requiring dialysis (i.e. eGFR \< 30)
* Patients not likely to complete the trial as per judgment of the investigator.
Emergency Department Management of Tobacco Use Disorder

The objective of this study is to determine the effectiveness of ED initiated NRT on tobacco cessation point abstinence rates as reported by patients at 2 weeks and 1 month post randomization, and continued abstinence rates at 3 months compared to standard of care therapy.


Eligibility Criteria:
Inclusion Criteria:

* Current daily use cigarettes greater than or equal to ½ pack per day
* Stable for discharge from the ED
* Able and willing to complete telephone/electronic follow up at scheduled intervals
* Reported English speaking

Exclusion Criteria:

* Patients enrolled in specific health insurance plans (PEIA, The Health Plan or Medicaid medical insurance)
* WVU students
* Medically unstable patients
* Patients with clinical decompensation or who are admitted to the hospital
* Patients who are discharged to residential treatment facilities for detoxification
* Uncontrolled psychiatric disorder or psychiatric emergency
* Individuals who are unable to provide consent
* Incarcerated individuals
* Language barrier
* Currently pregnant or attempting to become pregnant
* Presenting for evaluation of sexual assault
* Known allergy or previous intolerance to nicotine replacement therapy
Adolescent Acts of Kindness Intervention

Adolescents will complete a 4-week intervention, during which they will either complete a kind act for others, complete a kind act for themselves, or report their daily activities three days per week. Psychological and physiological measures will be indexed before and after the intervention.

Stress and early adversity have been found to influence immune function via enhanced expression of the conserved transcriptional response to adversity (CTRA) genetic profile. Expression of this genetic profile was reduced in adults who completed a prosocial behavior intervention. This project aims to implement this intervention in adolescents. 90 high school students will be recruited and assigned to one of three groups (30/group). Participants will either conduct 3 acts of kindness for themselves, conduct 3 acts of kindness for others, or report about their day 3 times per week for 4 weeks. During this intervention, they will receive text messages 3 days per week instructing them to complete their respective act. Participants will provide a brief description of this act that evening, as well as complete brief surveys at the end of the week for each week of the intervention. Participants will come into the lab twice, once before and once after the 4-week intervention. During these lab sessions participants will complete survey measures, have their heart rate measured, and have a blood draw conducted by a trained phlebotomist. Participants' parents will also complete a brief survey to provide demographic information and an idea of what prosocial behaviors participants witnessed in their home. The investigators will use these data to assess the effects of prosocial behavior on health and the psychological mechanisms underlying these effects. At the second study visit, participants will be given the opportunity to donate part of their study payment to a charity to measure prosociality. Any donations will be vetted with the psychology department's accounting group prior to making any donations in the university's name. Scott Monatlik, Director, Tax and Information Practices, at smonatlik@finance.ucla.edu or (310) 794-6724 will be contacted and information regarding the appropriate steps to take to ensure that the donation is made to an acceptable charity prior to any donations. Actual helping behavior (donations) is measured to provide an ecologically valid experimental evaluation of prosociality rather than traditional metrics of computerized, fictional giving. Conceptual frameworks from developmental and health psychology guide the hypothesis that prosocial behavior will influence adolescents.

Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 14-17

Exclusion Criteria:

* None
Impact of Antiphospholipid Antibodies on Thrombin Generation During Sars-CoV2 Infection (TACIT2 Study)

Context: Until 70% of thrombotic event are reported during Sars-CoV2 infection. Antiphospholipid antibodies (aPL) tests are often positive. We aim to determine if aPL positivity is involved in thrombose of Sars-CoV2 infection investigating the effect of aPL on thrombin generation (TG) and leucocyte pathway activation (neutrophils extracellular traps (NETs) and activation of triggering receptor expressed on myeloid cells 1 (TREM-1)).

Method: We will compare plasma from five groups of subjects: patients with antiphospholipid syndrome (APS) and patients hospitalized for Sars-CoV-2 infection with or without aPL, and as control, patients with acute venous thromboembolism event and healthy volunteers. For each subject, we will analyze aPL, activated protein C (APC) resistance measured by TG and leukocytes markers as circulating neutrophils extracellular traps (NETs) and soluble triggering receptor expressed on myeloid cells one (sTREM-1). We will control aPL test at three month and analyze their persistent positivity and association with thrombotic event.

Results: we hypothesize that patients with COVID-19 and aPL will have a similar aPL and level of APS resistance that patients with APS. Also, we think that circulating NETs and sTREM-1 levels will be more important in patients with COVID-19 with aPL than patients without aPL and similar in patients with COVID-19 and aPL and patients with APS.

Conclusion: our study will be the first to analyze the potential role of aPL on APC resistance measured by TG and neutrophil activation in COVID-19.


Eligibility Criteria:
Inclusion Criteria:

* Patient receiving a comprehensive information about the study, and not opposed to participate

  + one criterion among :
* patient hospitalized fo a COVID-19
* Patient with known APS
* Patients hospitalized for an acute venous thromboembolism event aPL positivity or COVID-19
* healthy volunteers

Exclusion Criteria:

* For all participants : pregnancy, age below 18 years-old, absence of written informed consent , autoimmune or inflammatory disease except antiphospholipid syndrome
* For patients with COVID-19: previous aPL positivity (before COVID-19 infection)
* For patients with APS: previous symptomatic COVID-19 infection
* For patients control with acute venous thromboembolism event: previous symptomatic COVID-19 infection, infection or inflammatory disease in flare at the time of thromboembolism event, known aPL positivity
* For Healthy volunteers: history of thrombosis (venous, arterial or small vessels), previous symptomatic COVID-19 infection, infection or inflammatory disease in flare at the time of inclusion, known aPL positivity
Effective Mechanisms of Wu-Chu-Yu Tang on Gastroesophageal Disorder

Gastroesophageal reflux disorder (GERD) is due to gastric content reflux to esophagus cause symptom and complication including intra-esophagus such as reflux esophagitis, and extra-esophagus such as cough etc. Because the changes of dietary habit, and improvement of examination skill and data analysis, the prevalence of GERD increased 2.5 multiple from 1995 to 2002, and suggesting the prevalence is 25% in Taiwan community.

The etiology of GERD is multi-effect, such as transient lower esophageal sphincter relaxation and abnormal pressure of lower esophageal sphincter, which may induced the esophageal mucosal injury by gastric acid, bile or pancreases enzyme.

Wu-Chu-Yu tang consists of Evodia fargesii Dode (Evodia Fruit), Panax ginseng C. (Ginseng), Ziziphus jujube Mill (Chinses Date), Zingiber officinale Rosee (Fresh Ginger).According to "I-Fang-Chi-Chieh" and "Shanghonzobinglun" recordings that Wu-Chu-Yu tang can treat vomiting, and also can relax gastric tonicity and can enhance peristalsis of stomach. According to Randomized, double blind, placebo control trial to evaluate the efficacy of Wu-Chu-Yu Tang on gastroesophageal reflux disease, we know the Wu-Chu-Yu tang have the equivalent effect proton pump inhibitor omeprazole. But, the mechanism of Wu-Chu-Yu tang is still unknown.


Eligibility Criteria:
Inclusion Criteria:

1. Gender：male or female.
2. Age：from 20 years old (inclusive) to 75 years old (inclusive).
3. Diagnosis of gastroesophageal reflux disease.
4. there is a heartburn or acid regurgitation phenomenon.
5. After detailed description of the entire research purpose or process, voluntarily participate in the study and sign the consent form.

Exclusion Criteria:

1. Exclude peptic ulcers, gallstones (including intrahepatic and common bile ducts) and major diseases such as: cancer, congestive hear failured NYHA class\>II, COPD attack.
2. Barrett's esophagus, narrow esophagus or caustic injury of upper gastrointestinal tract.
3. History of esophagus and gastroduodenal surgery.
4. Tarry stool suspected gastrointestinal bleeding.
5. History of alcohol or drug abuse.
6. Patients with a history of allergies to the test drug.
7. Can not cooperate with mental illness.
8. Pregnant women or women who are breastfeeding.
9. Liver function SGOT and SGPT are more than twice the normal value.
10. renal function test BUN, Creatinine is greater than the normal value.
Immune Dysregulation in Hepatitis C Patients With or Without Arthritis

The purpose of this study is to study the role of the Immune System in causing arthritis in patients with Hepatitis C.

Patients will provide one blood sample after qualifying for the study, and signing consent. The patients will have a skin test TB, Candida, and Trichophyton placed and will read the results themselves and mail back the card with the measurements to be recorded. Labs will test for ESR, CBC, CRP, antiCCP, Cryoglobulins, RF, CH50, C3, C4, Flow cytometry, and would have already been tested for HIV and Hepatitis C.

Eligibility Criteria:
Inclusion Criteria:

* All adults 18 or older, 20 will have hep C positive with a viral load withen 6 mo. of enrollment.
* Either interferon or antiviral naive or those who failed interferon or antiviral therapy more than 6 mo. prior to enrollment.
* 10 normal healthy controls- Hep C neg and without osteoarthritis (OA).

Exclusion Criteria:

* HIV patients
* Those with concomitant alcoholic liver disease
* Patients with Rheumatoid Arthritis (RA) or other autoimmune disorders.