cyrilzakka/clinical-trials huggingface dataset:
NOWDx Test for the Detection of Antibodies to COVID-19 in Lay Persons

This study is designed to compare the performance of the NOWDx COVID-19 Test to an emergency use authorized PCR test result. The intent is to show the rapid test device is comparable to a currently marketed device. The NOWDx COVID-19 Test is an in vitro lateral flow immunoassay intended for qualitative detection of total antibodies to SARS-CoV-2 in human fingerstick whole blood at the Point of Care (POC); i.e. in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation; and at home.

This study is designed to compare the performance of the NOWDx COVID-19 Test to an emergency use authorized PCR test result. The intent is to show the rapid test device is comparable to a currently marketed device. The NOWDx COVID-19 Test is an in vitro lateral flow immunoassay intended for qualitative detection of total antibodies to SARS-CoV-2 in human fingerstick whole blood at the Point of Care (POC); i.e. in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation; and at home.

The NOWDx COVID-19 Test is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. Testing of human fingerstick whole blood is intended to be conducted in a home-like setting of a facility authorized to perform CLIA waived tests.

Eligibility Criteria:
Inclusion Criteria:

Innate Infection Cohort\>

* PCR positives: persons who were symptomatic for COVID-19 and have tested positive for COVID-19 with an EUA or FDA cleared PCR test; 7+ days post positive PCR test
* PCR negatives: persons who have never had COVID-19 and who have tested negative for COVID-19 with an EUA or FDA cleared PCR test; within 0-6 days post negative PCR test
* persons 2+ years old

Vaccination Cohort\>

* persons 7- 60 days post second dose of EUA COVID-19 vaccine
* persons 18+ years old

Exclusion criteria:

Innate Infection Cohort\>

* PCR positives: persons with a COVID-19 positive test result \>45 days old
* PCR negatives: persons with any prior COVID-19 positive result
* persons who have received COVID-19 vaccine
* persons \<2 years old

Vaccination Cohort\>

* persons symptomatic or previously infected with COVID-19 prior to vaccination
* persons \<18 years old
A Study Comparing Duloxetine and Placebo in Assessing Energy and Vitality in Major Depressive Disorder (MDD) Patients

Study F1J-US-HMFS comprises two identical multicenter, 9-month, randomized, placebo-controlled, double-blind, trials (HMFSa and HMFSb). The purpose of this study is to compare the efficacy and safety of Duloxetine 60 milligrams (mg) once daily to placebo on depression in patients aged 18-65. Data from the two trials will be reported in both individual and pooled analyses. Pooling the two studies will allow for increased power to detect differences between duloxetine and placebo on secondary and exploratory objectives. Only one data lock is planned for this study, when all patients have completed all study procedures.


Eligibility Criteria:
Inclusion Criteria:

* Male or female outpatients
* Aged 18-65 who meet the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) diagnostic criteria for Major Depressive Disorder (MDD)
* Have a Montgomery-Asberg Depression Rating Scale (MADRS) total score of at least 22 at visits 1 and 2
* Have a Clinical Global Impressions of Severity Scale (CGI-S) score of at least 4 at visits 1 and 2
* Have a degree of understanding such that the patient can provide informed consent, complete protocol required assessments and communicate intelligibly with the investigator and study coordinator.

Exclusion Criteria:

* Patients judged clinically to be at serious suicidal risk in the opinion of the investigator
* Patients who have any prior history of bipolar disorder, psychosis, or schizophrenia
* Patients who have any current (within the past six months) DSM-IV-TR primary Axis I disorder other than MDD
* Patients with uncontrolled narrow-angle glaucoma
* Patients who have a serious medical illness that is in the opinion of the investigator not stabilized or is likely to require intervention, hospitalization, or use of an excluded medication during the course of the study.
Chewing Gum Test for the Diagnosis of Giant Cell Arteritis (Horton's Disease) - ChewingHort

It is hypothesized that chewing-gums may be a useful test to unmask jaws intermittent claudication in order to enhance the diagnosis of Giant Cell Arteritis (GCA).

GCA is the most common vasculitis. The diagnosis easily could be made in patients over 50 years old with headache, inflammatory belt pain, claudication of the jaws, scalp hyperesthesia, ophthalmological manifestations and an inflammatory syndrome. However, the clinical pictures could be less suggestive, hence diagnostic difficulties. Some patients have only isolated inflammatory syndrome. To confirm the diagnosis, sometimes PET CT or temporal artery biopsy is used, but access to a PET CT is sometimes complex, biopsy of temporal arteries is only positive in about 70% cases. Early diagnosis is important, however, to avoid irreversible complications, especially ophthalmological complications. One in six patients has definitive amaurosis, because of diagnosis delay. The current diagnostic delay is estimated on average at 9 weeks.

Jaw intermittent claudication probably has a very good positive predictive value and this clinical sign often carries conviction. Patients with claudication of the jaws also have a greater visual risk. Kuo reports two observations of patients with claudication of the jaws revealed by the "chewing gum test" after 2 minutes of chewing. It is therefore proposed to perform a chewing gum test to assess the sensitivity and specificity of this test, compared to the interview.

Once the test is done, the study is completed for the patient.

Eligibility Criteria:
Inclusion Criteria:

* Group 1
* Any patient suspected of having GCA, that is to say in practice patients in whom a doctor plans a Doppler ultrasound of temporal arteries or a temporal arteritis biopsy or an imagery (Angio-CT, Angio-MRI, PET- to scan
* Patient over 50 years old
* Patient able to chew a chewing gum for 4 minutes Group 2
* Patients free from GCA
* Age matched (± 3 years)
* Patient able to chew a chewing gum for 4 minutes

Exclusion Criteria:

* Group 1
* Patients known to have a temporomandibular joint pathology
* Patients who started corticosteroid therapy Group 2
* Patients known to have temporomandibular joint pathology
* Patients who started corticosteroid therapy
Low-Dose Risperidone Treatment for Subjects Suffering From Borderline Personality Disorder

Personality disorders are life-long maladaptive behavioral patterns. Borderline personality disorder (BPD) is the leading personality disorder encountered in clinical settings, often associated with tremendous distress. It is characterized by impulsivity, emotional lability, unstable interpersonal relationships, with particular sensitivity to abandonment. BPD patients are prone to self destructive behaviors and all too frequently attempt suicide. When in emotional turmoil, persons with BPD may also develop brief, transient psychotic states.

Psychotherapy for BPD is a common treatment option, but it requires considerable time and specific personnel training, and is therefore not always feasible. Medical treatment is an efficacious alternative, however there is no concensus on drug selection. Some experts have suggested that medical treatment should be selected individually according to the subject's dominant clinical symptom. Several psychopharmacological groups have been proposed: Antidepressants, mood stabilizers, and several novel antipsychotic drugs. The latter are particularly promising since they may produce symptomaic improvement with fewer adverse effects. Risperidone has been shown in a few preliminary studies to be promising in the treatment of various BPD symptoms, but no controlled study has tested it yet. We propose to test the efficacy of risperidone in the treatment of BPD in a double-blind crossover design using both clinical and phsysiological measure.The main hypothesis is that risperidone will be efficient in alleviating BPD core and secondary symptoms.


Eligibility Criteria:
Inclusion Criteria:

1. Women with Borderline PD according to DSM-IV
2. Signed informed consent.
3. Age 18-45.

Exclusion Criteria:

1. Psychotic disorders (past or present).
2. Substance or alcohol related disorders (past or present).
3. Current major depressive episode.
4. Suicidal risk.
5. History of head trauma, which caused loss of consciousness or peritraumatic amnesia or necessitated hospitalization.
6. Any known psychiatric or general medical condition currently requiring specific medical attention.
7. Current treatment with any antipsychotic, antidepressant drugs or mood stabilizers.
Physiotherapy in the Reduction of Post-needling Soreness

Dry needling is a minimally invasive technique which generates good results and neuromuscular benefits. Its application involves a highly prevalent effect called post-needling soreness. It is defined as a residual pain, located in the incision area, with a self-limiting period of 24-72 hours, as a result of a physiological process generated by the technique.

So far, different clinical trials have been carried out to measure the effectiveness of several techniques for reducing post-needling soreness, reaching positive results. However, no studies have been found with the aim of distinguish which method is more effective for this goal; therefore, it is clear the need to continue investigating on the subject and comparing these techniques among them.

Main objective. To figure out if one of the four techniques (isometric, concentric, eccentric contraction exercise and analytic passive stretching) is more effective for reducing post- needling soreness immediately, at 12, 24, 48 and 72 hours.

Objectives. To verify if there is a correlation between independent variables and post-needling soreness.

Study type. Non-blinded randomized clinical trial. Intervention. Dry needling on an active myofascial trigger point in superior trapezius, followed by one of the following treatments according to the specific group: 1) concentric contraction exercise, 2) isometric contraction exercise, 3) eccentric contraction exercise or 4) analytic passive stretching.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 65 years;
* Cervical pain.
* Presence of an active PGM in the upper trapezius muscle.

Exclusion Criteria:

* Traumatic history in the cervical region;
* Inability to understand or perform the required exercises;
* Pregnancy in the first trimester;
* Altered state of coagulation;
* Immunosuppression status;
* State of alteration of sensitivity (e.g. central sensitization processes, fibromyalgia, etc.);
* Unavoidable fear of needles;
* Lack of knowledge about the use of the WhatsApp or Telegram messaging platform
Acupuncture for Functional Constipation in Older Adults

Through a scientific and standardized randomized controlled study, we observe the effectiveness and safety of acupuncture in the treatment of functional constipation in the elderly through the method of "nourishing kidney and dredging Fu organs".

Functional constipation is a common disease of old people. To date, there has not specific therapy on it. Former research showed acupuncture may work for functional constipation. In the trial, patients in the acupuncture and sham acupuncture groups will receive 24 acupuncture treatments over an 8-week period. This RCT is designed to confirm the efficacy and safety of acupuncture in functional constipation treatment.

Eligibility Criteria:
Inclusion Criteria:

* Meet Rome IV Diagnostic Criteria for Constipation and TCM Diagnostic Criteria of constipation with yin deficiency syndrome;
* No gender restriction, age 60-80;
* FC that is classified as mild or moderate;
* Have not used any medicine for constipation at least 2 weeks before treatment (except emergency treatment);
* Have not participated in other medical clinical trials over the past one month;
* Those who can understand various evaluation scales, complete the evaluation and cooperate with the completion of the planned course of treatment;
* Sign the informed consent.

Exclusion Criteria:

* Irritable bowel syndrome and constipation caused by tumors, inflammatory reactions, endocrine and metabolic diseases, and drugs;
* Constipation caused by organic diseases;
* Patients with serious primary diseases such as heart, brain, liver, kidney and hematopoietic system, infectious diseases, tumors, and mental diseases;
* Those who voluntarily give up or cannot cooperate with treatment and observation due to various circumstances;
* Patients with cognitive impairment or aphasia;
* Those who take other drugs during treatment, which affect the efficacy and judgment (except emergency treatment).
Feasibility and Safety of Neoadjuvant Chemotherapy (FLOT ) for Gastric Cancer Patients in China

Neoadjuvant chemotherapy for advanced-stage gastric cancer is justified by various studies, however, there was not any large scale randomized controlled trial (RCT) to support it until German oncologist introduced a novel regimen(FLOT regimen) in 2017. Investigator assessed the FLOT regimen for safety and feasibility in Chinese gastric cancer patients.

Neoadjuvant chemotherapy for advanced-stage gastric cancer is justified by various studies, however, there was not any large scale RCT to support it until German oncologist introduced a novel regimen(FLOT regimen) in 2017. FLOT regimen was prescribed for German patients and various questions are raised by experts from Eastern countries. As the FLOT regimen was officially included in NCCN 2018 guidelines, the investigator used standard protocol of FLOT regimen on Chinese gastric cancer patients. Safety and feasibility were assessed carefully to provide basic data for further large scale studies in China.

Eligibility Criteria:
Inclusion Criteria:

* Sex: all
* Histology confirmed adenocarcinoma of the stomach or esophagogastric junction.
* Clinical stage: Clinical Tumor-Node-Metastasis (cTNM): stage III，IVa
* Performance status: Eastern Cooperative Oncology Group ECOG 0- 2
* Adequate renal, hepatic, hematologic, and pulmonary function.
* Written informed consent

Exclusion Criteria:

* Uncontrolled cardiac disease, or other clinically significant uncontrolled comorbidities
* Distant metastases
* Prior chemo or radiotherapy
* Inclusion in another clinical trial
* Known contraindications or hypersensitivity for planned chemotherapy
Safety, Tolerability, PK, PD of Escalating Single and Multiple Oral Doses of CJ-12420 in Healthy Male Subjects

The objectives of this study are:

* To evaluate the safety and tolerability of single and multiple oral doses of CJ-12420 in healthy male subjects.
* To evaluate the single- and multiple-dose PK of orally administered CJ-12420 in healthy male subjects.
* To evaluate the single- and multiple-dose PD of orally administered CJ-12420 in healthy male subjects.
* To compare the multiple-dose pharmacodynamics (PD) of orally administered CJ-12420 and esomeprazole in healthy male subjects.


Eligibility Criteria:
Inclusion Criteria:

* Male volunteers in the age between 20 and 45 years old (inclusive)
* Body mass index (BMI) in the range of 19 to 28 kg/m2 and weighing at least 50 kg
* Medically healthy with no clinically significant vital signs (sitting position blood pressure, pulse rate) (90 mmHg ≤ systolic blood pressure ≤ 140 mmHg, 50 mmHg ≤ diastolic blood pressure ≤ 95 mmHg, 45 beats per minute ≤ pulse rate ≤ 95 beats per minute)
* Non-smokers or non-users of nicotine-containing products for at least 3 months

Exclusion Criteria:

* History of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, musculoskeletal or cardiovascular disease or any other condition, which, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results
* History of allergy or sensitivity to any drug, including any prior serious adverse reaction to PPIs (e.g. omeprazole, rabeprazole, lansoprazole)
* History of symptomatic GERD, erosive esophagitis, duodenal ulcer, gastric ulcer, Barrett's esophagus or Zollinger-Ellison syndrome, previous positive H. pylori
Misoprostol Prior to Intrauterine Device (IUD) Insertion in Nulliparous Women

The purpose of this study is to see if using misoprostol makes the intrauterine device insertion easier and less painful in women who have never had a baby.

The Intrauterine Device (IUD) is an excellent contraceptive option because of its ease of use, long term duration (5-10 years), low side-effect profile, and the immediate return to fertility after IUD removal. Despite advantages associated with the IUD, the smaller cervical diameter of nulliparous patients may lead to a more difficult and uncomfortable insertion. Some providers have started pre-medicating nulliparous patients with misoprostol prior to IUD insertion because of the drug's known effect as a cervical ripening agent. Limited evidence is available addressing the effect of misoprostol on patient comfort and provider ease of IUD insertion in nulliparous women. The goal of this study is to evaluate whether using misoprostol as a cervical ripening agent in nulliparous patients eases IUD insertion and decreases pain.

Eligibility Criteria:
Inclusion Criteria:

* 14 years old or older
* Negative pregnancy test
* No prior pregnancies lasting beyond 19 6/7 weeks
* Minimum 2 weeks after spontaneous or medical abortion
* Minimum 4 weeks post 2nd trimester or surgical abortion
* No previous IUD insertions
* No PID in last 3 months
* No current cervicitis
* Willing to follow-up in 1-2 months for an IUD string check

Exclusion Criteria:

* Active cervical infection
* Current pregnancy
* Prior pregnancy beyond 19 6/7 weeks gestation
* Known uterine anomaly
* Fibroid uterus distorting uterine cavity
* Copper allergy/Wilson's Disease (for Paragard)
* Undiagnosed abnormal uterine bleeding
* Cervical or uterine cancer
Comparison Between Point of Care Device and Venous Blood International Normalized Ratio Measurements.

Investigate the validity of Hemosense System in pediatric patients on anticoagulation therapy.

Over the last few decades there has been an increased use of Warfarin in the pediatric population stemming from the use of mechanical heart valves and palliative surgical procedures requiring anticoagulation therapy. Other patients with enzymatic deficiency within the coagulation cascade may develop thrombosis treated with anticoagulation, i.e. factor V Leiden deficiency. Prevention of poor outcome from thrombosis has required closer monitoring in the pediatric patient. In addition, absorption of Warfarin in the pediatric population is highly variable and depends on the child's age, weight, diet, and concurrent use of other medications (Desai, 2000). This makes achieving anticoagulation very difficult. "Because of the intrinsic differences in the coagulation systems in children and adults, guidelines for antithrombotic therapy in adults cannot be extrapolated to pediatrics" (Desai, 2000). Therefore, pediatric patients on anticoagulation therapy require frequent lab work to monitor their prothrombin time and international ratios (PT/INR).

There are a number of barriers to care when discussing anticoagulation therapy for pediatric patients. Frequent venous blood draws represent a painful procedure that elicit anxiety and fear which leads to noncompliance. In addition, children are more difficult to obtain blood samples because of smaller vessels, patient movement during procedure, and the volume of blood that is required for the test. Other barriers include the time delay from when the patient has the lab work drawn, to when the result get to the provider for any patient care decisions to be made.

There are a number of Point of Care devices available for near-patient testing of the PT/InR's that requires only a finger stick. These monitors have been validated against standardized laboratory testing, in order for the monitor to be certified by the FDA. Similar studies to validate finger stick methods in pediatric patients have not been completed. The aim of this project is to validate the accuracy of Hemosense, a point of care device, to venous blood PT/InR level in the pediatric population.

Eligibility Criteria:
Inclusion Criteria:

- All pediatric patient requiring Warfarin therapy.

Exclusion Criteria:

1. Subjects older then 18 year of age.
2. Pregnant subjects.
Nurse Parental Support Using a Mobile App in Symptom Management for CMC

Parents of children with medical complexity (CMC) are suffering from high level of stress. These CMC get multisystem diseases, including severe neurologic conditions or cancer, resulting in potential premature death. They experience one or more physical and psychological symptoms at one time, which seriously affect their quality of life and increase their health services utilization. Parents may lack confidence in their abilities when managing their child's symptoms. Literature suggested that increasing parental self-efficacy in managing their child's symptoms could improve child's health status. Home-based nursing services for the CMC and parents are available in Hong Kong. However, the service faces challenges because of serious nursing workforce shortage and the recent coronavirus pandemic. Nurse parental support in symptom management using a proactive mobile health App is an alternative method considered more feasible to continue home-based support for the CMC and parents.

This proposed RCT will test the effects of a nurse-led mobile App for enhancing parental self-efficacy in symptom management for CMC. A repeated-measures, two-group design will be used to evaluate the effects between intervention and wait-listed control groups by comparing the study group receiving nurse support using a mobile App, and the wait-listed control group receiving usual community care for 96 randomly selected parents over a three-month follow-up. Primary outcome is parental self-efficacy. Secondary outcomes include children's symptom burden and health services utilization. These factors will be measured before intervention, immediately after intervention and three-month after intervention. The effectiveness of the intervention will be evaluated by comparing the primary outcome at three-month after intervention across the two study groups using ANCOVA with control for the pre-test value of parental self-efficacy. Generalized estimating equation will be used to address secondary objectives regarding the effectiveness of the mobile App as compared to the control on secondary outcomes from T1 to T3 with appropriate link function. It is hypothesized that nurse support using the mobile App is more effective than usual community care in enhancing parental self-efficacy in symptom management for their CMC at three-month after intervention.


Eligibility Criteria:
Inclusion Criteria:

The eligible criteria for parents are:

1. parent of a child with medical complexity aged 2-18
2. having a Smartphone
3. able to communicate in Chinese and read Chinese
4. living with his/her child at home.

Exclusion Criteria:

The exclusion criteria for parents are

1. a reported mental health disorder
2. engaging in other structured programs related to symptom management 3) living in an area with no internet coverage.