cyrilzakka/clinical-trials huggingface dataset:
Physician-Patient Communication Project

Over half of all Americans take dietary supplements (vitamins, minerals, herbal products) along with their prescription medications. With the economic downturn, dietary supplement sales have surged, perhaps as a result of people attempting to stave off or delay medical care. Supplements are generally thought to be harmless, but some can potentially interact with prescription medications, cause liver or kidney damage, and even adversely affect surgical outcomes. Those substituting dietary supplements for prescription medications also may suffer significant adverse consequences. The United States Food and Drug Administration and the Institute of Medicine recommend that patients considering dietary supplement use consult their providers. Unfortunately, patients fail to disclose dietary supplement use in up to two-thirds of outpatient office visits. To improve discussions, it is important to understand what prompts physicians and patients to communicate about dietary supplements.

The overall objectives of this application are to understand how, when and why physicians and patients communicate about dietary supplements, and to assess how patients respond to these discussions. An ethnically diverse group of patients and their physicians will be surveyed and their office visits will be audio recorded. Audio recordings of the visits will be used to assess the relationship of patient and physician attitudes and values, and the physician-patient relationship on dietary supplement discussions. A subset of these patients and physicians will be interviewed to explore how they made decisions to initiate or forgo discussions about supplements. They also will be asked questions concerning the necessity of and responsibility for initiating dietary supplement conversations. Patient responses and reactions to actual discussions also will be explored. Data from observed and reported interactions will be compared to provide a deeper understanding of factors related to disclosure. This project aims to provide a broad understanding of the content of physician-patient discussions about dietary supplements, and to describe how and why physician and patient attitudes and opinions affect these discussions. Identification of mutable factors can result in interventions to increase communication about dietary supplements, help maintain patient safety, and promote appropriate use of supplements concurrent with prescription medications.

Sixty one primary care and integrative or complementary and alternative medicine physicians will be recruited for the study. For each participating physician, ten patients will be recruited.

Eligibility Criteria:
Inclusion Criteria:

* English or Spanish-speaking
* Aged 18 and older

Exclusion Criteria:

* Does not speak English or Spanish
Use of Injectable Platelet Rich Fibrin in Lichen Planus

Platelet Rich Fibrine (PRF), which promotes wound healing by supporting angiogenesis, immunity and epithelial proliferation phases. over a decade has since past since PRF was developed and many clinicians now point to the potential use of a liquid version of PRF. a liquid injectable-platelet-rich fibrin (i-PRF) was developed by modifying spin centrifugation forces. At lower centrifugation speeds and by utilizing non-glass centrifugation tubes, the fibrin coagulation could be slowed down at early time points thus generating an injectable PRF. Much like traditional PRF, i-PRF contains an increase in leukocyte number and is further able to stimulate growth factor release.

Lichen planus is a common chronic mucocutaneous inflammatory disorder which generally affect s middle aged adults. Therapeutic methods including topical and systemic corticosteroids for the treatment of oral lichen planus (OLP) are suggested. However, long

-term use of corticosteroids may be associated with local and systemic complications, and moreover, some patients may not be responsive.

The investigators aimed to apply a treatment of autogenous origin (including no foreign products), considering the side effects of our corticosteroids. The study was designed as a split mouth.

The investigators planned to administer I-PRF to one side and intralesional corticosteroid therapy to the other side at patients with bilateral atrophic / erosive oral lichen planus lesions

Lichen planus diagnosis will be made histopathologically. Intraoral photographs and measurements will be taken at the beginning of the treatment and 2 months after the treatment is finished.

Eligibility Criteria:
Inclusion Criteria:

1. Oral erosive lesions were diagnosed according to Andreasen classification.
2. Histological confirmation of erosive OLP according to the World Health Organization's clinicopathological diagnostic criteria for OLP.
3. No previous treatment of oral lichen planus at least 3 months.
4. Willingness and ability to complete the present clinical trial.
5. Patients of ages above 18 years old without skin involvement.

Exclusion Criteria:

1. Histological signs of dysplasia.
2. Using drugs associated with lichenoid reaction.
3. Pregnant, lactating and smoker patients.
4. Patient with systemic diseases such as diabetes mellitus, immunodysfunction, hematological and hepatological patients or had photosensitivity history.
Phase II Study of Efficacy and Safety of HSK39297 Tablet in Treatment of Patients with Primary IgAN

Evaluate the efficacy and safety of HSK39297 tablets in patients with primary IgAN


Eligibility Criteria:
Inclusion Criteria:

1. Subjects must have signed and dated an IRB/IEC approved written informed consent form.Subjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests, tumor biopsies, and other requirements of the study.
2. Female and male patients above 18 years of age.
3. Patients must weigh at least 35 kg to participate in the study, and must have a body mass index (BMI) below 35 kg/m2. BMI = Body weight (kg) / \[Height (m)\]2
4. Subjects with a biopsy-verified IgA nephropathy and where the biopsy was performed within the prior five years.
5. Urine protein ≥0.75g/24hr or FMV UPCR≥0.8g/g at screening.
6. Measured Glomerular Filtration Rate (GFR) or estimated GFR (using the CKD-EPI formula 2021) ≥30 mL/min per 1.73 m2.

Exclusion Criteria:

1. Use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or within 90 days, whichever is longer.
2. All transplanted patients (any organ, including bone marrow).
3. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in-situ cervical cancer), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
4. Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the subject in case of participation in the study.
5. Pregnant or nursing (lactating) women.
6. Plasma donation (≥ 400mL) within 12 weeks prior to first dosing.
Impacts of a Physical Therapy Protocol on Motor Function in Children With Congenital Zika Syndrome

The study aims to evaluate the effects of a specialized physiotherapy protocol aimed at the motor function of children with Congenital Zika Virus Syndrome. First, participants' anthropometric parameters (weight and length) and motor functions were assessed. After that participant were splited in two groups: Experimental group that uunderwent a one-hour daily protocol (5 times a week) of stimuli and handling based on the neuroevolutionary concept, and motor physical therapy with therapeutic garments (PediaSuit). On the other hand, the control group (CG) kept the therapeutic routine (conventional physical therapy).


Eligibility Criteria:
Inclusion Criteria:

* Children with confirmed CZS diagnosis by RT-PCR or presumed by imaging findings (CT or MRI \[or both\]), and according to the Center for Disease Control and Prevention criteria
* Children accompanied by the support center where the study was conducted.

Exclusion Criteria:

* Children who did not undergo assessments after the intervention
* Children those weighing \< 9,600 kg, with uncontrolled seizures, or orthopedic changes (e.g., hip subluxations or dysplasia, severe spasticity combined with joint contractures, and severe scoliosis \[Cobb angle \> 40°\]).
Waitlist-Control Trial of Smartphone CBT for Major Depressive Disorder (MDD)

The investigators are testing the efficacy of Smartphone-delivered cognitive behavioral therapy (CBT) treatment for major depressive disorder (MDD). The investigators hypothesize that participants receiving app-CBT will have greater improvement in QIDS-C scores than those in the waitlist condition at treatment endpoint (week 8).

The primary aims of this study are to test the efficacy of a Smartphone-based CBT treatment for adults with MDD recruited nationally. Eligible subjects (N=112) will be randomly assigned to 8 weeks of Smartphone-delivered CBT for MDD either immediately, or after a 8-week long waiting period (50-50 chance). The investigators hypothesize that Smartphone-delivered CBT for MDD will be feasible and acceptable to individuals with MDD, and that it will lead to greater reductions in MDD symptom severity compared to the passage of time (waitlist control).

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Current diagnosis of primary DSM-5 MDD, based on MINI
* Currently living in the United States

Exclusion Criteria:

* Psychotropic medication changes within 2 months prior to enrollment (Participants taking psychotropic medication must have been on a stable dose for at least 2 months prior to enrollment and not change medication during study period)
* Past participation in ≥ 4 sessions of CBT for depression
* Current severe substance use disorder
* Lifetime bipolar disorder or psychosis
* Acute, active suicidal ideation as indicated by clinical judgment and/or a score ≥ 2 on the suicidal ideation subscale of the C-SSRS
* Concurrent psychological treatment
* Does not own a supported mobile Smartphone with a data plan
* Lack of technology literacy that would interfere with ability to engage with smartphone treatment
Evaluate the Efficacy and Safety of ABT-126 in Subjects With Mild to Moderate Alzheimer's Disease on Stable Doses of Acetylcholinesterase Inhibitors

This is an efficacy and safety study evaluating a new treatment for subjects with mild to moderate Alzheimer's disease.

This is a Phase 2 study designed to evaluate the efficacy and safety of ABT-126 in approximately 420 adults with mild to moderate Alzheimer's disease who are taking stable doses of acetylcholinesterase inhibitors. Subjects will be randomized to one of two ABT-126 dose arms or placebo for a 24-week treatment period.

Eligibility Criteria:
Inclusion Criteria:

* The subject and caregiver must voluntarily sign and date an informed consent. If the subject does not have the capacity to provide informed consent, full informed consent must be obtained from the subject's representative and assent must be obtained from the subject.
* The subject is a male or female between the ages of 55 and 90 years, inclusive, at Screening Visit 1. Main Inclusion (Continued):
* The subject meets the Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria for probable AD.
* The subject must be receiving a stable dose of an AChEI (donepezil or rivastigmine) for at least 90 days prior to Screening Visit 1.
* The subject has a Mini-Mental Status Examination (MMSE) total score of 12 to 24, inclusive, at Screening Visit 1.
* The subject has a Cornell Scale for Depression in Dementia (CSDD) score ≤ 10 at Screening Visit 1.
* The subject has a Modified Hachinski Ischemic Scale (MHIS) score of ≤ 4 at Screening Visit 1.
* With the exception of a diagnosis of mild-to-moderate Alzheimer's disease and the presence of stable medical conditions, the subject is in general good health, based upon the results of medical history, physical examination, vital signs, laboratory profile, and a 12-lead electrocardiogram (ECG).
* The subject has an identified, reliable caregiver who will provide support and ensure compliance with the study medication and procedures, and provide accurate information about the subject's status during the study.

Exclusion Criteria:

* The subject has taken galantamine or memantine within 60 days prior to Screening Visit 1.
* The subject has received excluded concomitant medications.
* The subject has clinically significant abnormal laboratory values at Screening Visit 1 as determined by the investigator.
* The subject has a history of any significant neurologic disease other than Alzheimer's disease including Parkinson's disease, multi-infarct or vascular dementia, Huntington's disease, normal pressure hydrocephalus, progressive supranuclear palsy, multiple sclerosis, any seizures, mental retardation or a history of significant head trauma followed by persistent neurologic deficits or known structural brain abnormalities.
* In the opinion of the investigator, the subject has any clinically significant uncontrolled medical or psychiatric illness.
Post Transjugular Intrahepatic Portosystemic Shunt (Tips) Albumine Infusion to Prevent Hepatic Encephalopathy

The purpose of this study is to evaluate the efficacy of albumin infusion to prevent post tips hepatic encephalopathy'

The outcome is the prevention of post tips hepatic encephalopathy

Eligibility Criteria:
Inclusion Criteria:

* Cirrhotic patients
* TIPS placement
* Absence of Hepatic Encephalopathy at the enrolement
* Age \> 18 years
* No pregnancy

Exclusion Criteria:

* Non-cirrhotic portal hypertension
* Previous liver transplantation
* Impossibility to attend the scheduled follow-up including the weekly visit as outpatients during the first month after TIPS (see the description of follow-up below)
* Sings of overt hepatic encephalopathy as well as a history of persistent HE at entry. The latter as a contraindication for TIPS placement
Identification the Cause of Cerebral Infarction in Patients With Cancer

Although there has been increasing interest in the association between cancer and cerebrovascular disease, the underlying pathophysiology of stroke in cancer patients is still not fully understood. The aim of this study is to investigate the stroke mechanisms in patients with cancer-associated stroke.

Patients with cryptogenic embolic stroke will be prospectively enrolled and categorized into two groups according to the presence of active cancer: cryptogenic embolic stroke with active cancer (cancer-associated stroke) vs. without active cancer (cryptogenic embolic stroke). All patients will undergo brain MRI/MRA, 12-lead electrocardiography, transthoracic and transesophageal echocardiography with injection of agitated saline, and 24-hour Holter and/or telemonitoring. Duplex ultrasonography to detect venous thrombosis of the lower extremity will also be performed in patients with a positive right-to-left shunt on echocardiography.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with acute ischemic stroke who presented within 7 days from symptom onset
* Subjects who had embolic infarction outside the perforator territory revealed by diffusion-weighted imaging
* Subjects with undetermined cause of stroke despite of initial evaluation including electrocardiogram and brain imaging upon admission
* Subjects who performed brain magnetic resonance image (MRI) and MR angiography (MRA), cardiac work-ups (12-lead electrocardiography, transthoracic and/or transesophageal echocardiography with injection of agitated saline (or agitated saline transcranial Doppler monitoring), and 24-hour Holter and/or telemonitoring)
* Subjects with informed consent

Exclusion Criteria:

* Subjects with single subcortical infarction
* Subjects with primary brain tumor
* Inability to perform comprehensive studies
* Refusal or withdrawal of the consent
A Phase I Study to Investigate the Effect of Renal Impairment on the Pharmacokinetics, Safety, and Tolerability of AZD5004

This is a Phase I, multicentre, single-dose, non-randomised, open-label, parallel-group study to examine the PK, safety, and tolerability of AZD5004 in male and female participants with severe renal impairment and moderate renal impairment (optional) compared with male and female participants with normal renal function.

This is a Phase I, multicentre, single-dose, non-randomised, open-label, parallel-group study to examine the PK, safety, and tolerability of AZD5004 in male and female participants with severe renal impairment and moderate renal impairment (optional) compared with male and female participants with normal renal function.

Participants will be assigned to the following groups based on eGFR determined at screening by a local laboratory using serum creatinine:

Group 1: Participants with severe renal impairment (eGFR \< 30 mL/min), not on dialysis.

Group 2: Participants with normal renal function (eGFR of ≥ 90 mL/min) matched by sex, age, and body weight on a group level to the impaired participants.

Group 3 (optional): Participants with moderate renal impairment (eGFR ≥ 30 to \< 60 mL/min).

Eligibility Criteria:
Inclusion Criteria:

* Adults 18-80 years of age
* Weight \>50kg and BMI between 18-40 kg/m2

For participants with normal renal function:

-Participant must be medically healthy with no significant findings on medical evaluation and an eGFR ≥90 ml/min at screening.

For participants with renal impairment:

Group 1 (severe) must have an eGFR \<30 ml/min and Group 3 (moderate) must have an eGFR 30 to \<60 ml/min based on CKD-EPI calculations for at least 6 months prior to enrollment.

Exclusion Criteria:

* Poorly controlled diabetes mellitus (A1C \>10% at screening or recent history of diabetic ketoacidosis or symptomatic hypoglycemia).
* Unwillingness to use adequate contraception
* Uncontrolled hypertension or hypotension.
* Positive screening for HIV, Hepatitis B, or Hepatitis C
* Presence of unstable systemic disease or psychologic conditions. Abnormal laboratory values to include but not limited to liver function tests (thresholds differ for renal impairment and health controls)
* Any change in baseline medication within 2 weeks of planned study initiation.
A Multi-Center Study to Assess the Performance of Saturation Patterns.

A multi-center, prospective, single-visit study designed to acquire physiologic pulse oximeter waveform data during standard polysomnography (PSG) studies performed at multiple different Sleep Lab Centers.

The polysomnograms are clinically indicated studies in patients suspected of having sleep-disordered breathing, including, but not limited to: obstructive sleep apnea, complex sleep apnea and/or central sleep apnea. Subjects who have been prescribed with needing a polysomnography (PSG) will be enrolled into the study.

Eligibility Criteria:
Inclusion Criteria:

* Subjects will be referred to the Sleep Lab Center for evaluation of possible sleep-disordered breathing.
* Polysomnography (PSG) is obtained as part of normal, standard clinical practice.
* Subject is able to and willingly signs the informed consent form.

Exclusion Criteria:

* Subject and/or parent/legal guardian is, in the opinion of the investigator, mentally and/or physically unable to provide informed consent/child assent and/or to complete all requirements of the protocol.
* Subject is currently participating in or has participated in an investigational drug study within seven (7) days of enrollment.
A Study of E7080 in Subjects With Solid Tumor

The purpose of this study is to investigate the tolerability and safety of E7080 up to 24 mg when administered orally on a once daily continuous dose schedule in cycles (4 weeks as 1 cycle) in subjects with solid tumors


Eligibility Criteria:
Inclusion Criteria

* Subjects with histologically and/or cytologically diagnosis of solid tumor
* Subjects with solid tumor which is resistant to standard anti-tumor therapies, or which no appropriate treatment is available
* Subjects whose toxicity of previous treatment has recovered to Grade 1 or lower toxicity (except for alopecia)
* Subjects who completed previous anti-tumor therapy before at least 4 weeks
* Subjects who are 20 years or older
* Subjects with 0 to 1 of Performance Status
* Subjects agree to be hospitalized for DLT observation
* Subjects with adequate organ functions
* Males and females of childbearing potential must agree to use appropriate contraception from the agreement to 30 days after study drug administration.
* Agree to participate in this study in writing based on voluntary will

Exclusion Criteria

* Subjects with brain metastasis accompanying clinical symptoms or requiring treatment
* Subjects with the severe complication or disease history
* Subjects unable to take oral medication.
* Subjects being treated with drugs that strongly inhibit or induce CYP3A4 and that may be possibly used during this study.
* Scheduled for surgery during the projected course of the study.
* Positive for human immunodeficiency virus (HIV antibody) test or positive for hepatitis B surface (HBs antigen) or hepatitis C (HCV antibody) by serum test.
* Subjects who in the view of the investigator are not able to comply with this protocol because of psychiatric or physical diseases including alcoholism or drug addict
* Pregnant or nursing subjects
* Subjects who are participating in another clinical trial.
Evaluate the Safety, Tolerability, and Antiviral Activity of GLS4 With Ritonavir in Patients With Chronic HBV Infection

The experiment is divided into two parts: Part 1 and Part 2.Part 1 was the initial treatment patient and Part 2 was the treated patient.

About 125 subjects were planned to be included and assigned to the experimental group and the control group according to 4:1.At the same time, a liver biopsy group was set up in each part of the population to receive liver biopsy during the screening period and 48 weeks after completion of drug administration, which was used to detect HBV DNA, cccDNA, HBsAg, and evaluate the degree of liver inflammation and fibrosis.

Eligibility Criteria:
Inclusion Criteria:

* Chronic HBV infection population
* HBeAg positive
* HBsAg≥250 IU/mL
* No cirrhosis

Exclusion Criteria:

* AST\>5×ULN
* Platelet count less than 90E+09/L
* TBil\>1.5×ULN
* albumin\<35 g/L
* INR\>1.5
* AFP\>50 ng/mL