cyrilzakka/clinical-trials huggingface dataset:
Auramine Phenol Staining Technique for Revealing Different Coccidian Parasites

The increased number of documented human coccidian infections, including Cryptosporidium parvum, Cyclospora cayetanensis, Isospora belli, and Sarcocystis spp., that are often indistinguishable from other forms of community-acquired diarrhea, together with the possibility of treating some of them, suggests a need for proper diagnostic techniques to recover and identify these organisms

The increased number of documented human coccidian infections, including Cryptosporidium parvum, Cyclospora cayetanensis, Isospora belli, and Sarcocystis spp., that are often indistinguishable from other forms of community-acquired diarrhea, together with the possibility of treating some of them, suggests a need for proper diagnostic techniques to recover and identify these organisms.

Earlier, Cryptosporidium and Cystoisospora were assumed to be the causative agents of acute diarrhea in animals but recently have emerged as one of the leading causes of prolonged lifethreatening diarrhea in immunocompromised patients particularly in those with immune dysfunction like AIDS who may show severe intestinal injury, prolonged diarrhea, extreme weight loss, and generalized wasting. In contrast, healthy individuals commonly present with mild to moderate self-limiting diarrhea during the infective stage, besides asymptomatic infection can also occur.

Detection of coccidian parasites is mostly through microscopic observation using Kinyon's acid-fast stain. Although Sheather sugar flotation may result in increased concentration of the cysts, this method is cumbersome and does not lend itself to convenient incorporation within the routine concentration and staining procedures favored in most clinical laboratories. Any acid-fast stain will be taken up by cyst walls, but the time required to prepare and examine acid-fast stains on all stool samples received for routine parasitology would not be cost-effective unless the prevalence of coccidian parasites was shown to warrant such effort.

Eligibility Criteria:
Inclusion Criteria:

* patients complaining of chronic diarrhea .

Exclusion Criteria:

* patients taking antibiotics within the previous four weeks, and anti-parasitic drugs within the previous two weeks.
A Study Investigating the Distribution and Metabolism of Three 14C-labeled Radioactive Study Compounds

People with type 2 diabetes have too much sugar in their blood and need treatment to control their sugar level. The 3 study compounds in this study are similar to an approved antidiabetic medicine that helps to lower blood sugar levels in people with type 2 diabetes. This approved antidiabetic medicine is generally safe and well tolerated. The study compounds are expected to have the same antidiabetic effect as the approved medicine. The purpose of this study is to investigate how quickly and to what extent each of the 3 study compounds are broken down in the body (this is called pharmacokinetics). The dose of each study compound will be very low (this is called a microdose), and will be labelled with a small amount of carbon-14. This is radioactive, and it makes it possible to track the study compound in the blood. The 3 study compounds in this study have not been given to humans before. The study will be performed in up to 18 healthy male volunteers. The study will consist of 3 groups of 6 volunteers each. Each participant will receive only one dose of study medicine.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subject.
* Sex : Male.
* Age 18 to 54 years, inclusive, at the time of signing informed consent.
* Body mass index (BMI) 18.0 to 30.0 kg/m\^2, inclusive, at the time of signing informed consent .

Exclusion Criteria:

* Known or suspected hypersensitivity to study product(s) or related products.
* Any disorder that in the Investigator's opinion might jeopardise subject's safety, evaluation of results, or compliance with the protocol.
* Glycosylated haemoglobin (HbA1c) equal to or above 6.5% (48 mmol/mol) at screening.
* Personal or first-degree relative(s) history of multiple endocrine neoplasia Type 2 or medullary thyroid carcinoma.
* Subjects with a history of malignant neoplasms within the past 5 years prior to screening.
* Presence or history of pancreatitis (acute or chronic; as declared by the subject or reported in the medical records).
* Participation in a study with a radiation burden of above 0.1 millisievert (mSv) in the period of 1 year prior to screening.
Development of a Comprehensive AP Training Curriculum for Adults

An e-learning training program is to prepare people with diabetes and their physicians on the use of UVA's Artificial Pancreas prototype -- Diabetes Assistant (DiAs).

This project will develop and test a comprehensive, web based training system for the artificial pancreas (AP) prototype identified as eDAPT (electronic Diabetes Artificial Pancreas Training). This e-learning training program is to prepare people with diabetes and their physicians on the use of UVA's Artificial Pancreas prototype -- Diabetes Assistant (DiAs), a software platform for the development and outpatient testing of smart phone based systems for Closed Loop Control of diabetes. The e-learning training program will be used in adjunct to in-person training with study staff at the onset of a clinical trial. It will be especially important as the number of clinical sites that use DiAs continue to grow both in the United States and internationally. It is also a critical step in moving the DiAs closer to a commercial product. A validated training program is required to proceed with the Food and Drug Administration (FDA) for both pivotal clinical trials and commercial approval of the AP.

Eligibility Criteria:
Diabetes Clinicians Inclusion Criteria:

* Endocrinologist, Certified Diabetes Educator, Nurse Practitioner actively managing patients with type 1 diabetes on insulin pumps and continuous glucose monitoring therapy
* Actively managing patients using insulin pumps for at least one year

Former \& Novice Study Subjects Inclusion Criteria:

* Have Type 1 Diabetes Mellitus as defined by American Diabetes Association criteria or judgment of physician for at least 1 year
* No previous experience with the artificial pancreas system in a clinical trial
* Currently using insulin pump to manage their type 1 diabetes for at least one year
* Actively using an insulin pump with bolus calculator feature including predefined parameters for carbohydrate ratio, insulin sensitivity factor, target BG and active insulin
* Knowledge of continuous glucose monitors

Former Study Subjects Inclusion Criteria:

• Previous experience with the artificial pancreas system in a clinical trial
Concurrent Transcranial Direct Current Stimulation and Gait Training in Parkinson's Disease

To investigate the effect of concurrent transcranial direct current stimulation and gait training on gait performance when doing the cognitive dual-task in people with Parkinson's Disease.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with idiopathic PD
* Hoehn and Yahr stages I-III
* Mini Mental Status Examination (MMSE) score ≧ 24
* Could walk 10m independently with or without gait aid

Exclusion Criteria:

* Concurrent medication likely to affect mental performance
* tDCS contraindication
* Significant neurological, vestibular, visual disorders or psychiatric illness
* Musculoskeletal or cardiopulmonary disease
* Sensory system pathology
The Celljuvant Study: A Phase 3 Immunogenicity and Safety Study of aQIVc Vaccine in Adults Aged 50 Years and Older

This is a Phase 3, randomized, parallel-group, comparator-controlled, observer-blind, multicenter study of immunogenicity and safety in approximately 7700 male and female adults aged 50 years and older (approximately equally split between two age groups: 50-64 years; 65 years and older), who are healthy or have stable comorbidities that increase their risk of complications from influenza infection. Three lots of aQIVc will be evaluated for consistency and pooled for the comparison with the 2 control vaccines.

Subjects will be randomly assigned to receive 1 of 3 lots of aQIVc, QIVr, or aQIV in a 1:1:1:2:2 ratio (for a 3:2:2 ratio for aQIVc, QIVr, and aQIV).

The study will have a treatment period (Day 1 to Day 29) and a follow-up period (Day 30 up to Day 181); a subset of 770 subjects will be followed up up to Day 365.


Eligibility Criteria:
Main Inclusion Criteria:

* Individuals, aged 50 years and older, who are healthy or have stable comorbidities that increase their risk of complications from influenza infection
* Individuals who can comply with all study procedures

Main Exclusion Criteria:

* Progressive, unstable, or uncontrolled clinical conditions
* Known hypersensitivity or allergy to any study vaccine component
* Known history of Guillain-Barré syndrome or other demyelinating disease
* Condition representing a contraindication to vaccination or blood draw
* Abnormal function of immune system due to known disorder or medication.
* Influenza vaccination within 180 days prior to informed consent.
VITAL Start: Brief Facility-based Video Intervention

This a multi-center, parallel group, randomized controlled outcome assessor blinded trial with a qualitative descriptive component that seeks to assess the effectiveness of a brief facility-based video intervention to optimize retention and adherence to ART among pregnant and breastfeeding women with HIV infection.

Universal HIV testing and treatment can accelerate population-level ART initiation and is critical to realize the UNAIDS 90-90-90 goals. Malawi pioneered Option B+ (B+), a novel application of test-and-treat that provided life-long ART for HIV+ pregnant and breastfeeding women. While maternal ART uptake improved 7-fold, retention and adherence remained suboptimal: only 59% were retained after two years, and of these, only two-thirds achieved adequate ART adherence. Other B+ countries are observing suboptimal retention.

VITAL Start (Video-intervention to Inspire Treatment Adherence for Life) is a brief facility-based video intervention, created with formative participatory research, applied theoretical frameworks, and evidence-based message framing techniques. VITAL Start was designed to help optimize retention and adherence to ART among pregnant and breastfeeding women in Malawi.

The study will evaluate the impact, implementation and cost effectiveness of VITAL Start in a multisite randomized controlled trial (RCT) in Malawi with the primary composite outcome of retention and adherence (viral suppression) 12 months after starting antiretroviral therapy (ART). The study will also examine the delivery of VITAL Start via surveys and interviews with patients and partners and conduct cost-effectiveness analyses.

If successful, VITAL Start will provide an intervention that (1) standardizes and improves counseling at a critical teaching moment through an engaging and culturally sensitive experience, (2) is inexpensive and rapidly scalable without decelerating ART expansion, and (3) allows more efficient use of health care worker time.

Eligibility Criteria:
Inclusion Criteria:

* Women who are HIV positive by two antibody rapid tests approved by the Malawi Ministry of Health
* Women age ≥18 years or 16-17 years if married or have a child
* Women who understand chichewa
* Women who are willing to provide informed consent
* Women who intend to remain in the health center catchment area for at least 6 months

Exclusion Criteria:

* Women already on ART
* Women with significant pre-existing psychiatric comorbidity at enrollment that may impact ability to provide consent according to the clinical judgment of study personnel (including cognitive impairment or known psychotic disorder)
* Women who participated in the study pilot
Compare the Efficacy and Safety of Donepezil Hydrochloride 23 mg Treatment With Continuation of Donepezil Hydrochloride 10 mg Treatment in Japanese Subjects With Severe Alzheimer's Disease

The purpose of this study is to compare 23 mg donepezil sustained release to the currently marketed formulation of 10 mg donepezil immediate release in patients with severe Alzheimer's disease.


Eligibility Criteria:
Inclusion Criteria

* Diagnosis: diagnostic evidence of probable Alzheimer's disease (AD) consistent with Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV-TR) 290.00 or 290.10
* Mini Mental State Examination (MMSE) less than or equal to 12 and greater than or equal to1 inclusive, at Screening
* SIB less than or equal to 90 and greater than or equal to10 at both Screening and Baseline
* No evidence of focal disease to account for dementia on any cranial image (magnetic resonance imaging \[MRI\] or computed tomography \[CT\]).
* Subject age range: male and female subjects greater than or equal to 50 years of age inclusive
* Outpatients (patients in nursing homes are eligible)
* The subject must have a caregiver who will provide informed consent separately for his/her own participation in the study, who will have regular contact with the subject.
* Stable donepezil dose of 10 mg, taken as a single, daily dose for greater than or equal to 3 months prior to the Screening visit
* Subjects who can swallow hole tablets, as tablets should not be broken or crushed
* Comorbid medical conditions must be clinically stable prior to Screening unless otherwise specified.
* Written informed consent will be obtained from the subject (if possible) or from the subject's legal guardian or other representative (according to Japanese regulations as appropriate) prior to beginning screening activities.

Exclusion Criteria

* Subjects with a known history of disorders that affect cognition or the ability to assess cognition but are distinguishable from AD
* Subjects with dementia complicated by other organic disease or AD with delirium
* Known hypersensitivity to donepezil or piperidine derivatives, or to any of the excipients in the study drug formulation
* Patients who are expected to live in a nursing home within 24 weeks after randomization (eligible if temporary)
* Use of any prohibited prior or concomitant medications. Memantine will be allowed if taken at prescribed doses that are less than or equal to 20 mg/day, provided that the dose has been stable for at least 6 months prior to Screening.
HFNC Treatment in COVID-19 Pneumonia

coronavirus disease 2019 related pneumonia is causing acute respiratory failure and this is the most common reason for ICU admission. We have several different way for respiratory support. HFNC is one of the new technics for oxygen support. Our main purpose to observe the effect of HFNC on coronavirus disease 2019 patients' ICU stay and mortality.

In the first group (group H), the data of patients undergoing HFNC treatment, and in group II (Group K), the data of patients who received COT with a reservoir mask were included.

In HFNC support, the current air temperature is 31-37 degrees, the flow rate is 30-60 lt / min, and the FiO2 value is targeted so that saturation is 93% and above. Initially, continuous treatment was applied intermittently after the partial oxygen pressure / fraction of inspired oxygen(fio2) ratio exceeded 250 and clinical well-being occurred.

In patients in Group K, fingertip saturation was targeted as 93% and above, and a COT was applied with a reservoir mask with a flow rate of 6-15 l / min.

The flow rate was calculated using the formula of FiO2 (%) = 21 + 4 \* (liters / min) in patients undergoing COT. Noninvasive mechanical ventilation was applied to patients who could not be provided with adequate clinical and laboratory well-being in both groups (partial oxygen pressure / fraction of inspired oxygen ratio below 150) and invasive mechanical ventilation if this was insufficient.

Eligibility Criteria:
Inclusion Criteria:

* We include the patient with acute respiratory failure related coronavirus disease 2019 (diagnosed with polymerase Chain Reaction), older than 18 year and supported by High Flow Nasal cannulae or conventional oxygen treatment(COT).

Exclusion Criteria:

* Patients with primary pulmonary disease, Glasgow Coma scale≤ 12 , respiratory acidosis in the first blood gases(ph≤ 7,2 - pCO2≥50) will exclude.
Promoting Health During Pregnancy: A Multiple Behavior Computer Tailored Intervention

This program of research tested the effectiveness of an iPad delivered multiple behavior intervention grounded in the Transtheoretical Model of Behavior Change for pregnant women. It was hypothesized that the intervention would reduce the number of health behavior risks reported by pregnant women in the treatment group. The target behaviors of the intervention are smoking cessation and relapse prevention, stress management, and fruit and vegetable consumption.

Promoting health behaviors during pregnancy has tremendous public health significance. Poor health behaviors are associated with pregnancy complications, birth outcomes, and the health of the child. They influence infant birthweight, premature birth, and infant mortality rates, all of which continue to be public health concerns, reflected in the goals of Healthy People 2020.

Pregnant women, particularly those from under-served populations, often have a multitude of health behavior risks that threaten positive pregnancy and birth outcomes, as well as the future health of mother and baby. Pregnancy offers a window of opportunity for behavioral intervention. The immediate health risk for the baby motivates most pregnant women to at least consider changing their behavior. Furthermore, the regular and continual medical care that most pregnant women receive allows optimal access for intervention. The circumstance of pregnancy can be used as a teachable moment to better the future health of women and children.

The primary goals of this study were to complete and enhance the development of an iPad delivered intervention and to assess the efficacy in a randomized clinical trial involving pregnant women from three federally-funded community health centers that treat under-served populations. Using interactive technology, users complete onscreen assessments and receive individually tailored feedback messages on key behavior change strategies identified by the Transtheoretical Model of Behavior Change and matched to their stage of readiness for each behavior. Supplemental intervention components were created including printed feedback reports, a multiple behavior stage-based manual, and Spanish versions of all intervention materials. This intervention offers a cost-effective, science based, and easily deliverable solution to improve multiple health behaviors, and overall health and well-being, of populations of pregnant women.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old
* Speak and read either English or Spanish
* Consent to the research.

Exclusion Criteria:

* More than 18 weeks gestation
Clinical Study of First-line Treatment of Small Cell Lung Cancer (SCLC) With Anlotinib Hydrochloride

This study was designed to investigate the efficacy and side effects of combining erlotinib with classical EC/EP chemotherapy regimens.

Lung cancer is a common malignant tumor that poses a serious threat to human health. Small cell lung cancer accounts for about 20% of lung cancer. Precision medicine has recently been perfectly interpreted in many tumor types, but the treatment of small cell lung cancer is still bleak. The EC/EP regimen is the most classic chemotherapy regimen for small cell lung cancer with good results but is prone to drug resistance. In 2018, with the development of immunotargeting therapy, small molecule multi-target anti-angi drugs, PARP inhibitors, new chemotherapy drugs, etc., the treatment of small cell lung cancer has ushered in a new dawn. As a kind of highly selective multi-target anti-angiogenic TKI drugs,Anlotinib Hydrochloride is a kind of 1.1 innovative drugs with independent intellectual property rights in China, mainly acting on VEGFR, PDGFR, FGFR and c-Kit. The latest ALTER1202 study confirms that anlotinib is significantly improved for PSC and ORR in SCLC patients who have previously received at least 2-line chemotherapy. OS data is not yet mature, but the benefits of the anlotinib group were observed. The adverse effects of anlotinib were consistent with expectations, no new adverse events were found, and safety was tolerated. Nowadays, the effective combination of traditional chemical therapy with molecular targeting and immunotherapy is the future development direction of lung cancer treatment. Therefore, this topic is designed to combine the efficacy of safety and safety with the treatment of anlotinib with the classic EC/EP chemotherapy regimen. Expected to get longer PFS and OS for patient benefit.

Eligibility Criteria:
Inclusion Criteria:

1. patients 18-75 years of age.
2. A metastatic or recurrent advanced SCLC confirmed by histology or cytology and did not receive any other treatment;
3. a measurable disease
4. an Eastern Cooperative Oncology Group PS of 0-1;
5. an estimated survival duration of \>6 months;

Exclusion Criteria:

1. Have used erlotinib or other anti-vascular targeted drugs (eg, Endo, bevacizumab, etc.)2. Patients who have been treated with chemotherapy or radiotherapy for previous tumors.3.Have appeared or merged with other tumors within 5 years.4.Patients with no measurable lesions; 5.any severe and uncontrolled disease.
Evaluation of Quality Indicators on Analgesia, Sedation and Delirium in Intensive Care Patients and Their Impact on Outcome Indicators and Economic Indicators

Retrospective cohort study to investigate the adherence to the process indicators for pain management, sedation management and management of delirium on outcome indicators and cost/revenues in individual patients and subcohorts.

The evaluation of quality-related process indicators (in this case, Quality Indicator II of the Intensive Care Quality Indicators of the DIVI\*: Management of Analgesia, Sedation and Delirium) will be correlated with economic parameters of the treatment from economic data (DRG revenue, case costs). Data from clinical routine care from the Charite hospital systems will be used with further analysis of outcome indicators from routine data (e.g. 30-day readmission rate, mortality, infection rate, length of stay). The aim of the study is to identify and evaluate incentive mechanisms for the implementation of quality-relevant care processes using the example of adherence to a quality indicator regarding management of analgesia, sedation and delirium) on detailed cost shares and case proceeds. In addition, further routine data, which may represent influencing factors like comorbidities (Charlson Comorbitity Index) are calculated using the ICD-10 coding. Also procedures using the OPS system are evaluated.

In this retrospective cohort study, patient records from the clinical information systems from 2012 to 2021 will be analyzed.. The analysis is also intended to analyze whether alternatively, cross-treatment outcome indicators can be defined, which would demonstrate not only positive patient-oriented results but also positive economic results as a potential incentive for health care service providers.

(\* DIVI: Deutsche Interdisziplinäre Vereinigung für Intensiv- und Notfallmedizin = German Interdisciplinary Association for Intensive Care and Emergency Medicine)

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years

Exclusion Criteria:

* Incomplete electronic records