cyrilzakka/clinical-trials huggingface dataset:
Digital Outpatient Services

More people are living with chronic or long-term disorders together and they live longer, which gives an increase in patients who need health services. Seen in the context of the shorter lengths of stay, and the outpatient clinics' increasing responsibility, there is a need to increase outpatient capacity without leading to more patient readmissions. Further, new services should take into account the patients capacity to benefit from the services, and their level of health literacy is crucial. By developing new services using technology, patients will be able to be followed up closely in their own home with adapted treatment and information, a closer dialogue with the health service where there is a need, and the utilization of scarce resources in the health care system can increase.

The aim of the current study is to evaluate a digital outpatient clinic, and assess any differences over time in health literacy, digital health literacy, quality of life and overall satisfaction with the outpatient services. Furthermore, the investigators will assess the intervention group's satisfaction with the digital outpatient clinic. In addition, the digital services will be tailored and revised throughout the study based on continuous feedback and iterative processes.

The current study is a pragmatic controlled multicenter study with two study arms; one control arm and one intervention arm. In total, eligible participants will be recruited from one of four centers.


Eligibility Criteria:
Inclusion Criteria:

* Patients attending the study centers that are cognitively able to use a digital outpatient service with no major conflicting disorders, with one of the following disorders:
* cancer
* epilepsy
* interstitial lung disease
* long-term complex pain conditions

Exclusion Criteria:

* under the age of 18
* any mental or cognitive conditions interfering with their ability to participate
A Study of SHR-4602 in Subjects With Advanced Malignant Solid Tumors

This is an open-label, three-part study to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of SHR-4602 and preliminary anti-tumor efficacy in HER2 expressing or mutated advanced malignant solid tumor subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Advanced/unresectable or metastatic solid tumor with HER2 expression or mutation that is refractory to or intolerable with standard treatment, or for which no standard treatment is available;
2. At least one measurable lesion based on RECIST v1.1 criteria;
3. ECOG PS score: 0-1 points;
4. Expected survival period ≥ 3 months;
5. Adequate organ function;
6. Must take one medically approved contraceptive measure;
7. Patients voluntarily joined the study and signed informed consent.

Exclusion Criteria:

1. Patients with known CNS metastasis or hepatic encephalopathy;
2. Suffering from peripheral neuropathy;
3. History of clinically significant lung diseases (e.g., interstitial pneumonia, pneumonitis, pulmonary fibrosis, and severe radiation pneumonitis) or suspected to have these diseases by imaging at screening period;
4. Patients with any active, known or suspected autoimmune disorder;
5. With known severe allergic reactions to any other monoclonal antibodies;
6. Patients with symptomatic ascites or pleural effusion requiring paracentesis and drainage, or patients who have undergone ascites or pleural effusion drainage within 2 weeks before the first dose;
7. Patients with other malignancies currently or within the past 5 years;
8. Uncontrolled cardiac diseases or symptoms;
9. With known hereditary or acquired bleeding (e.g., coagulopathy) or a tendency to clot (e.g., hemophiliacs);
10. Patients with other potential factors that may affect the study results.
Single Dose CHG Pharmacokinetic Study

A single 2% topical application of ReadyPrep® CHG was applied on either the abdomen (Treatment-1) or the groin (Treatment-2) whereas Treatment-3 consisted of a control treatment where the same procedure as Treatment-1 and -2 was performed, but without the topical application of ReadyPrep® CHG. The treatments were separated by a wash-out of 7 calendar days.


Eligibility Criteria:
Inclusion Criteria:

* Subjects were male or female, aged ≥ 18 and ≤ 60 years (inclusive). The main inclusion criteria were:

  * non- or ex-smokers
  * body mass index (BMI) ≥19.00 kg/m2 and ≤32.00 kg/m2 and a body weight ≥ 55 kg
  * negative pregnancy test for female subjects
  * healthy according to medical history, complete physical examination (including vital signs and skin examination) and laboratory tests (general biochemistry, hematology and urinalysis)
A Pilot Open-label Randomized Study of Lactofiltrum in Women With Bacterial Vaginosis

This is a phase II multicenter randomized open-label clinical study that will determine whether treatment with Lactofiltrum (orally administered tablets) in combination with antibiotic therapy (metronidazole) is effective in women with bacterial vaginosis. Lactofiltrum is a composite drug that includes enterosorbent lignin and prebiotic Lactulose. It's supposed that supplement of Lactofiltrum to a standard therapy of bacterial vaginosis (metronidazole administered orally) improves women's general state, leads to better recovery of clinical, microbiological, biochemical and histological features of the disease.


Eligibility Criteria:
Inclusion Criteria:

* bacterial vaginosis.

Exclusion Criteria:

* pregnancy and breast-feeding;
* concomitant infection diseases;
* systemic or topical treatment with antibiotics, steroids, immunosuppressive, cytostatic or antimetabolite agents by the time of inclusion;
* application of intravaginal medicines during participation in the study;
* severe diseases;
* renal and hepatic failure;
* application of pre-, probiotics and antibiotics 2 weeks before inclusion or during participation in the study;
* participation in other clinical study 1 month before inclusion or during participation in the proposed study.
Examining Adolescent Assessment, Feedback, Incentive, and Exchange (AFIX) in North Carolina

The North Carolina Immunization Branch will evaluate the use of the CDC program to improve adolescent vaccination practices (called Assessment, Feedback, Incentives, and eXchanges, or AFIX). This evaluation is the first of its kind in the nation and may have a profound impact on prevention.

AFIX has four major components: 1) Assessment of a provider's current immunization practices and vaccination levels, 2) Feedback of the assessment results and strategies to improve coverage levels, 3) Incentives to improve coverage levels, and 4) eXchange of information and resources necessary to facilitate improvement.

This program will evaluate the effectiveness of AFIX visits on affecting provider practices to increase adolescent (age 11-18) immunization. Visits include discussion of that practice's immunization rates and strategies for improving rates. The investigators will compare the changes, from baseline to 5 months, in immunization for practices receiving virtual visits (webinars), in-person visits, and no visits (control group). Thirty practices will be randomly assigned to each intervention type. The main outcomes of this study are practice-wide uptake rates of several adolescent vaccines (Tdap, HPV, and MCV4) as well as pre- and post-AFIX visit surveys focusing on recall tactics utilized by each practice. Data will be collected on practices with at least 200 adolescent patients (note: there is no patient-level data collected in this study).


Eligibility Criteria:
Inclusion Criteria:

* Pediatric and/or family practices participating in the North Carolina Immunization Program
* A minimum of 200 active adolescent patients
Study In Postmenopausal Women With Type 2 Diabetes Looking At Approved Diabetes Drugs And How They Affect Bone Health

The purpose of this study is to determine the effects of rosiglitazone on the bone in postmenopausal women with type 2 diabetes mellitus


Eligibility Criteria:
Inclusion Criteria:

* Female, \>55 to \<80 years
* \>5 years menopausal
* Type 2 Diabetes Mellitus (T2DM) diagnosis according to American Diabetes Association (ADA), American Association of Clinical Endocrinologists (AACE), Canadian Diabetes Association (CDA), World Health Organization/International Diabetes Federation (WHO/IDF)
* Drug-naïve (HbA1c \< or = 9.0%); OR Prior monotherapy, submaximal doses of metformin (\< or = 1000mg Metformin), sulfonylureas (\< or = 5mg Glyburide, \< or = 10mg Glipizide or \< or = 8mg glimepiride) or full dose Januvia (100mg) (HbA1c \< or = 8.5%); OR Prior monotherapy, \> submaximal doses of metformin (\>1000mg) or sulfonylureas (\>5mg Glyburide, \>10mg Glipizide or \>8mg glimepiride) (HbA1c \< or = 7.0%)
* Weighs \<300 lbs (136.4 kg)
* Two or more vertebra (L1-L4) suitable for BMD measurement by dual x-ray absorptiometry (DXA)
* Absolute BMD value consistent with T-score \>-2.5 at femoral neck, lumbar spine and total hip

Exclusion Criteria:

* Type 1 Diabetes Mellitus (T1DM) or history of diabetic ketoacidosis (DKA)
* Renal or hepatic disease (clinically significant)
* Hepatocellular reaction, severe edema, or medically serious fluid event associated with thiazolidinedione (TZD)
* Recent (\<6mos) history or clinical intervention for angina or myocardial infarction or is taking nitrates
* Any stage of heart failure, i.e. New York Heart Association (NYHA) class I-IV
* Systolic BP \>160mmHg or diastolic BP \>90mmHg while on antihypertensive
* Hypersensitivity to TZDs, biguanides
* Prior treatment with two or more oral anti-diabetic (OAD) agents
* Bilateral hip replacements
* Concurrent diseases affecting bone metabolism
* Active malabsorption syndrome
* Serum calcium outside the central lab reference range
* Thyroid replacement therapy, serum thyroid stimulating hormone (TSH) must be within range
* Vitamin D deficiency
* Previous treatment with: strontium, intravenous (IV) bisphosphonate, fluoride, hormones, calcineurin inhibitors or methotrexate
* Chronic systemic corticosteroid \[e.g. glucocorticoid, mineralocorticoid\] treatment of no more than two intra-articular injections within the past year or use of oral parenteral, or long-term, high-dose inhaled corticosteroids
Performance of 3 Sampling Methods for the Detection of SARS-CoV-2 (COVID-19) With Real-time Reverse Transcriptase PCR

The performance of 3 different sampling methods (2 nasopharyngeal swabs, 1 oropharyngeal swab) for the detection of SARS-CoV-2 with real-time reverse transcriptase polymerase chain reaction will be compared.

Thirty volunteers will be recruited from health care workers suspicious for Covid-19, who consult the ocupational physician for Covid-19 testing.

For each volunteer, 3 swabs will be taken:

* Flocked eSwab (Copan, Italy) of the oropharynx
* Flocked nasopharyngeal eSwab (Copan, Italy) of the nasopharynx
* Dry flocked nasopharyngeal Swab, placed in lysis buffer Each swab will be tested for the presence of SARS-CoV-2 with an in-house reverse-transcriptase real-time PCR (Egene).

Performance of each method will be calculated.

Eligibility Criteria:
Inclusion Criteria:

* health care workers with symptoms suspicious for Covid-19

Exclusion Criteria:

* none
Toothbrushes in Daily Practice in Patients with Fixed Orthodontic Appliances

Because of the difficulties of disorganizing the dental biofilm in these adolescents with fixed orthodontic treatment, electric toothbrushes have been proposed as an alternative to manual toothbrushes. Electric toothbrushes, available in a wide range of price points, have been developed with the goal of replicating the complex motions required by the manual toothbrush and making plaque removal more efficient. However, the overall effect size is limited, and the clinical relevance is not yet clear. Applied to orthodontics, specialized manual toothbrushes have also recently been developed. Few recent clinical trials have been conducted in patients with orthodontic appliances.

Thus, the question of whether and which type of manual or electric toothbrushes may be beneficial for patients with orthodontic appliances is still unresolved. Given the variety of toothbrushes available on the market, there is a need for sound clinical research to evaluate their effectiveness to guide professional recommendations. This work will provide a significant advance in the knowledge of the potential of the latest generation of electric toothbrushes on gingival inflammation, potentially reducing the risk of caries and gingival lesions.


Eligibility Criteria:
Inclusion Criteria:

* Children to be treated with fixed upper and lower braces
* 11 to 15 years of age at the start of treatment
* One parent/legal guardian agrees to the terms and conditions of the study and signs the informed consent form
* The adolescent agrees to the terms and conditions of the study and signs the informed consent form

Exclusion Criteria:

* Less than 20 permanent teeth with braces or brackets
* Presence of untreated cavities
* Bleeding greater than 10% on probing
* Presence of a gingival pocket larger than 5 mm
* Presence of fixed prosthetic restorations
* Presence of any enamel development defect
* Presence of dental anomalies or direct/indirect labial restorations on teeth
* Patients requiring orthognathic surgeries
* Presence of systemic diseases (diabetes, hepatic, renal, hematologic, cardiovascular)
* Use of medications that may affect gingival health (such as calcium channel blockers, ciclosporin and anticoagulants)
* Use of antibiotics and anti-inflammatory drugs for any purpose over a long period of time.
* Having a smoking habit
* Having a physical or mental problem that affects manual dexterity
* Being unable to answer questions or being uncooperative
Reduced Oestrogen Dosage to Improve the Outcome of Frozen-thawed Embryo Transfer

This study is a single-center, randomized, controlled prospective study. Those who will recieve hormone replacement therapy-frozen thawed embryo transfer (HRT-FET) are enrolled in the study. To determine the effect of oestrogen dosage reducion on maternal and fetal complications in HRT-FET cycles while maintaining the similar clinical pregnancy outcome in HRT-FET cycles with regular oestrogen dosage.

According to the enrollment and exclusion criteria, the patients were enrolled, and the subjects were randomly divided into two groups by computer randomization. Group A was the reduced oestrogen dosage group (test group). Group B was the regular hormone replacement group (control group).

Eligibility Criteria:
Inclusion Criteria:

1. Female;
2. Aged between 20 and 40 years old;
3. Frozen thawed embryo transfer is proposed, and the type of transferred embryo is blastocyst (the number of transferred embryos is 1);
4. Body mass index (BMI) ≤ 28 kg/m2, ≥ 18.5 kg/m2;
5. The total number of transfer cycles was \< 3;
6. Volunteer to participate in the study and sign the informed consent.

Exclusion Criteria:

1. Patients with chromosomal abnormalities;
2. Contraindications to hormone replacement therapy;
3. Patients with uterine myoma, severe adenomyosis, endometriosis, congenital uterine malformation, endometrial tuberculosis, intrauterine adhesions and other diseases that significantly affect embryo implantation;
4. Participating in other clinical studies.
Disulfiram Combined With Lorazepam for Alcohol Dependence and Anxiety Disorder

The proposed design is a single-group open-label trial. Qualified consenting participants with active alcohol dependence and primary or secondary anxiety disorder will receive monitored disulfiram and lorazepam, in the context of a structured Medication Management (MM) model. In weeks 9-15 lorazepam is tapered, and disulfiram is stopped at the end of week 16. Participants who achieve 4 weeks abstinence and meet criteria for a primary anxiety disorder or mood disorder may receive ancillary medication consisting FDA-approved non-benzodiazepine treatment, with specific options for each disorder described in the protocol. Participants requiring continued treatment are referred to clinical treatment in the community at week 16, and bridging prescriptions of anxiolytic/antidepressant medication may be provided. A final follow-up assessment occurs at week 28. The primary outcomes are Percent Days Abstinent (PDA) and retention in treatment. Secondary alcohol outcomes are consequences, drinks per drinking day, remission status, and time to first heavy drinking day. Anxiety outcomes are Hamilton Anxiety Scale scores and anxiety disorder diagnosis.


Eligibility Criteria:
Inclusion Criteria:

* Males and females age 18 and over with alcohol dependence.
* Able to provide voluntary informed consent.
* At least 4 heavy drinking days in the past 30 days.
* Primary or secondary anxiety disorder, including diagnoses of generalized anxiety disorder, panic disorder, social phobia, PTSD, obsessive-compulsive disorder, alcohol-induced anxiety disorder, or anxiety disorder not otherwise specified, ascertained by the SCID.
* Goal of abstinence.
* 2 days abstinence at the time of study entry (did not drink yesterday or today).
* Willing to come to clinic 3x/week.
* If female of child-bearing potential, willing to use approved method of contraception.

Exclusion Criteria:

* Moderate or severe withdrawal (CIWA-A greater than 15), history of withdrawal seizures or delirium tremens.
* Medical conditions (seizure disorder, sleep apnea, significantly impaired liver function, chronic or acute nephritis, symptomatic coronary artery disease, acute narrow-angle glaucoma).
* Urine drug screen positive for opioids or barbiturates.
* Hypersensitivity to thiuram derivatives.
* Pregnancy.
* Laboratory abnormalities (any LFT greater than 3 times normal, ECG evidence of ischemia, UA suggestive of nephritis, serious abnormalities of CBC).
* Need to take excluded medication (e.g. amprenavir oral solution, diazoxide oral suspension, isoniazid, lopinavir/ritonavir oral solution, metronidazole, omeprazole, phenytoins, ritonavir, tinidazole, tipranavir, warfarin, azelastine, sodium oxybate).
* Psychiatric conditions (schizophrenia, schizoaffective disorder, bipolar disorder; opioid dependence, benzodiazepine or other sedative hypnotic dependence).
One Hour Preoperative Gatifloxacin

Comparison of 1 day versus 1 hour application of topical Zymar.


Eligibility Criteria:
Inclusion Criteria:

* ophthalmic surgery

Exclusion Criteria:

* taken antibiotics, allergic to fluoroquinolones
Study of Suitable Schedule of Docetaxel,Anthracycline and Cyclophosphamide in Adjuvant Therapy of Beast Cancer

Anthracycline based regimens followed by a taxane (CALGB-9344 trial and NSABP-B28) or reversed (MD Anderson Adjuvant Trial) has already accepted as adjuvant therapy for node positive breast cancer. Also in this group of patients, data from BCIRG-001 trial had shown that six cycles of adjuvant TAC (docetaxel, doxorubicin and cyclophosphamide) is superior to standard FAC (5-FU, doxorubicin and cyclophosphamide ) combination in terms of both disease free and overall survival, while associated with a higher rate of febrile neutropenia. Then question arose whether it is better to use docetaxel and anthracycline in combination or sequence.

In this national wide study, women with node positive operable breast cancer are eligible for inclusion.Patients were designed to randomize to six cycles of adjuvant TAC (Taxotere® 75mg/m2, doxorubicin 50mg/m2 or epirubicin 60mg/m2, cyclophosphamide 500mg/m2), and four cycles of T(100mg/m2), followed by 4 cycles of AC(doxorubicin 60mg/m2 or epirubicin 75mg/m2 ,cyclophosphamide 600mg/m2). Prophylaxis with G-CSF was allowed for two arms when febrile neutropenia occurred in the first cycle of the study treatment. The second endpoint of this study is disease free survival. The primary objective is to compare the disease free survival rate and safety profiles of the above mentioned two arms.

Eligibility Criteria:
Inclusion Criteria:

* pT1-3,pN1-3,M0, operable breast cancer
* Karnofsky \>=80
* Pregnant test negative

Exclusion Criteria:

* Prior Chemotherapy with anthracyclines and / or Taxanes, except for Neoadjuvant therapy
* Prior breast radiation
* Bilateral breast cancer
* in-operable breast cancer
* Other health condition which may be contraindications for chemotherapy
* contraindications for Dexamethasone
Respiratory Kinematics During Voluntary and Reflex Cough in Healthy Adults

Cough is a defensive behavior that involves three stages. A large inspiratory phase, a compression phase where the vocal folds close and subglottal pressure is developed, and an expiratory phase. Cough serves to protect the upper and lower airways from material such as liquids, solids, or saliva, that have been aspirated. There are two types of cough: voluntary and reflex cough. Voluntary cough involves a cough to command. Reflex cough is a cough that is generated secondary to a stimulus in or near the airway. There has been some research regarding the differences between voluntary and reflex cough. However, no research has described the differences in airflow or movement pattern (kinematics) between the two types of cough. This study seeks to determine the respiratory kinematics and airflow differences between voluntary and reflex cough in healthy participants.

As a participant, completion of this study will require the following:

Investigators will first place cotton elastic bands around your chest and abdomen so that measures of chest wall and abdominal movements can be measured. Then, tests of your breathing made from pulmonary function testing will be completed.

Investigators will then have you complete a maximum inspiration followed by a maximum expiration three times.

Investigators will ask you to produce a voluntary cough three times into a facemask which is attached to a computer.

Then the investigators will provide you with nebulized water (FOG) through the facemask for up to a minute three times. You will have a minute break in between each presentation.

Finally, the investigators will provide you with a nebulized dose of Capsaicin, which is derived from hot peppers, through the same facemask used in all of the above tasks. You will receive three doses of capsaicin and be provided with water at any time during the study.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults between the ages of 18-80 years.
* Ability to provide informed consent.

Exclusion Criteria:

* No history of smoking within the last 5 years as this reduces the sensitivity to capsaicin
* No history of neurological disease (i.e. Parkinson's disease, stroke, traumatic brain injury, etc.)
* No known allergy to capsaicin
* No history of respiratory disease (i.e. asthma, chronic obstructive pulmonary disease, or respiratory infection within the last 5 weeks.)