cyrilzakka/clinical-trials huggingface dataset:
Clinical Efficacy of a Cephalic Mask for Noninvasive Ventilation During Acute Hypercapnic Respiratory Failure

Noninvasive ventilation (NIV) is now a major therapeutic option to manage patients with acute hypercapnic respiratory failure (AHRF). Otherwise, patient-ventilator interfaces are determinant to get an optimal NIV efficacy in parallel with ventilatory comfort.

Facial masks during NIV are associated with deleterious consequences like gas leaks around the mask, skin breakdown (especially on the nasal bridge), claustrophobia and mask discomfort. In order to limit these side effects, a cephalic interface has been recently designed. Cephalic mask covers the whole anterior surface of the face and excessive mask fit pressure is therefore spread over a larger surface outside the nose area. However, this mask has a high volume that may interfere with NIV efficacy and may also induce claustrophobic sensations.

The aim of this study is to compare the clinical efficacy and tolerance of a cephalic mask versus a conventional oronasal mask during AHRF.


Eligibility Criteria:
Inclusion Criteria:

* Acute hypercapnic respiratory failure
* Indication to noninvasive ventilation

Exclusion Criteria:

* Requirement for endotracheal intubation
* Proven pulmonary embolism
* Present or previous history of ophthalmologic disease
Comparison of Mirror Therapy and Modified Constrain Induced Movement Therapy on Risk of Fall, Balance and Gait in Stroke

There will be a difference between modified constraint induced movement therapy and Mirror Therapy on lower limb for risk of fall, balance and gait in stroke patients.


Eligibility Criteria:
Inclusion Criteria:

* A Hemiplegia due to unilateral stroke
* Sub-acute and chronic stroke
* Stroke survivors between 21 and 70 years old will be recruited
* Both genders
* NIH Stroke scale below 20
* Mini-Mental State Examination above 24
* Function in Sitting Test (FIST) above 42/56

Exclusion Criteria:

* Patients with depression who will be unable to cooperate during treatment
* Patients who cannot perform the active movement of limb due to prestroke muscoskeletal problems
* Cardiopulmonary diseases which could hinder their ability to participate in rehabilitation
* Spasticity of Modified Ashworth Scale (MAS) II or higher
* Patients with Any neuron disease and Patients with lower-limb impairment caused by other neurological diseases or inability to comply with study protocol will be excluded.
* Visual and auditory abnormalities
Transcutaneous Electrical Acustimulation in the Treatment of Mild to Moderate Ulcerative Colitis

The aim of this study was to evaluate the efficacy and safety of transcutaneous electrical acustimulation in patients with mild to moderate ulcerative colitis.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years
2. Ulcerative colitis diagnosed for at least 3 mouths.
3. Mayo score 4-10, Mayo endoscopic score 2-3 points
4. Resistant to at least one type of medical treatments

Exclusion Criteria:

1. Treatment-naive ulcerative colitis (no previous treatment)
2. Acute severe ulcerative colitis
3. Previous surgical treatment or severe colitis at imminent risk of surgery infective colitis
4. Other systemic diseases
5. Pregnancy and lactation
6. Allergic to the electrode patch
Assessing Pyridium for Post-Sling Urinary Retention

There has been preliminary data showing that pyridium can decrease the risk of difficulty urinating after midurethral sling. This study is designed to have two groups of patients. One group will receive pyridium pre-operatively, while the other group will have routine preoperative care. Both groups will have their bladder tested prior to going home. It will be evaluated if there is a difference in the difficulty to urinate post-operatively in both groups.

This is a prospective randomized controlled trial. It will have two arms with 48 patients in each arm, a total of 98 patients. Patients will be randomized with a block randomization schedule generated by computerized random numbers using a 1:1 allocation to pyridium and routine perioperative care. The study is powered to see a difference in incidence of urinary retention after midurethral sling using 25% as the historic control for our institution. Statistical sample size was based on a decrease in incidence to 5% in the pyridium arm. This is with 80% power and alpha 0.05. After the patient's surgery, including a midurethral sling, the patient will have an active voiding trial performed as described by Pulvino et al. The patient's bladder will be backfilled with 300cc of sterile saline. If the patient cannot tolerate 300cc, the patient will be filled to maximum capacity. The patient will be allowed 20 minutes to void. The patient must void greater than two thirds the volume that was instilled in the bladder to consider it a passed voiding trial. The timing of the voiding trial will be at the discretion of the surgeon, accounting for factors such as complexity of concomitant surgery, the patient being alert, ambulating, with tolerable pain.

Eligibility Criteria:
Inclusion Criteria:

* Any female patient undergoing a midurethral sling surgery, regardless of concomitant pelvic reconstructive or gynecological surgery

Exclusion Criteria:

* Patients with complications from surgery requiring indwelling catheter, bladder/urethral perforation requiring indwelling catheter
* Acute bleeding requiring indwelling catheter for accurate urine output calculation
* Patients undergoing concomitant surgery other than gynecological, preoperative voiding dysfunction defined as postvoid residual \>150cc, or spinal anesthesia
* Women who are pregnant, including women of childbearing age who test positive on preoperative urine pregnancy test
Benign/Malignant Pulmonary Nodule Classification Based on High-throughput Whole-genome Methylation Sequencing(GM-seq)

Lung cancer is the first cancer in China in terms of morbidity and mortality. The problem of early diagnosis/treatment has always been concerned. The popularization of chest CT (electronic computed tomography) screening makes it possible to detect lung cancer early. However, the diagnosis still needs pathological evidence. It is an ideal choice to obtain pathological evidence through bronchoscope and other minimally invasive means before surgical resection. However, the positive rate of tracheoscopy is still unsatisfactory, which is related to the difficulty of traditional pathological detection in detecting small specimens obtained by tracheoscopy. Liquid biopsy technology based on methylation detection has been used in early cancer screening, but its advantages have not been fully exploited due to the low content of ctDNA (circulating tumor DNA) in the current detection samples. Therefore, through prospective clinical research, the investigators plan to combine the methylation detection technology based on "Whole genome methylation sequencing(GM-seq)" with tracheoscopy, compare the traditional pathological methods with methylation detection on the bronchoscopic samples of lung nodule subjects suspected of early lung cancer, and take the postoperative pathology as the gold standard for judging benign and malignant, to confirm the feasibility and advantages of the new technology.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female, 20-75 year-old with pulmonary nodules 1-3cm in diameter confirmed by chest CT;
2. The nodules are single or multiple, suspected to be malignant, and have the indication of surgical resection;
3. Patient accept imaging evaluation without advanced lung tumors and metastases;
4. The location of the nodule in the lung is within the reach of lung biopsy under bronchoscope;
5. provide the collected clinical data needed by the research;
6. Patients have the ability to follow the planned schedule and actively cooperate to return to the hospital for regular clinical visits.

Exclusion criteria:

1. Unwilling to accept the invasive examination and treatment of this study;
2. Contraindication of tracheoscopy;
3. Consider that the pulmonary nodules are metastatic tumors or unresectable advanced lung cancer;
4. Those who cannot tolerate resection of pulmonary nodules;
5. Accompanied by other malignant tumors;
6. In the judgment of the researcher, the patient also suffers from other serious diseases that may affect the accuracy of the test;
7. Those who cannot accept the use of contrast-enhanced magnetic resonance imaging (MRI) or contrast-enhanced computed tomography (CT);
8. Any other illness, social / psychological problems, etc. are judged by the researcher to be unsuitable for participating in this study.
Pediatric Concussion Outcomes

This is a randomized, placebo-controlled, double-blinded trial in which subjects with a post concussive headache meeting inclusion criterion will be assigned to one of two treatment groups: placebo or nortriptyline. Each group will be evaluated at week 0 and again each week for the next 4 weeks of treatment with a concussion survey that rates their symptoms. At the end of 4 weeks the study will be unblinded. It is hypothesized that the addition of nortriptyline to the standard headache treatments will result in more rapid decrease of symptom score than with placebo.

Participants are randomly assigned to one of two treatment groups. The experimental group receives standard headache treatment including Tylenol, NSAIDs 2-3x/week, vestibular PT and daily nortriptyline 10mg oral. The control group also receives the standard headache treatment, but will instead be given a placebo, which will look physically identical to the nortriptyline capsule and be comprised of non-active pharmaceutical grade excipient.

Eligibility Criteria:
Inclusion Criteria:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Participants aged 13-21 years old
4. In good general health as evidenced by medical history and diagnosed with recent head trauma meeting ICHD-3 criteria for acute posttraumatic headache with symptom onset \< 7 days from trauma
5. Ability to take oral medication and be willing to adhere to the medication regimen
6. No loss of consciousness OR loss of consciousness \<30 minutes
7. Headache symptoms persisting ≥4 weeks post trauma
8. PCSHE score for headache + pressure in head + neck pain must be \> 3
9. After week 4 post-concussion at time of enrollment
10. Not currently receiving pharmacologic treatment for concussion asid from NSAIDs and acetaminophen

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation in this study:

1. Focal neurological deficits following injury
2. Any acute abnormality on Computed Tomography (if obtained)
3. History of known seizure disorder or moderate or severe TBI
4. Current uncontrolled psychiatric illness given the potential side effects of the study drug (at investigator discretion).
5. Current suicidal ideation as screened for on PHQ on intake
6. A personal history of Brugada syndrome
7. Known allergic reaction to nortriptyline
8. Current pregnancy
9. Positive COVID-19 test in prior 14 days
Vasopressor Outcomes in Spine Surgery

This is a prospective, randomized control trial comparing norepinephrine versus phenylephrine for vasopressor support in patients undergoing elective spinal fusion surgery.

There is limited evidence on the difference in postoperative outcomes between the choices of vasopressors used to treat intraoperative hypotension (IOH) in patients undergoing non-cardiac surgery under general anesthesia. A recent pilot feasibility trial comparing norepinephrine and phenylephrine for first-line intravenous infusion of vasopressor during general anesthesia and major non-cardiac surgery was unable to show any difference in postoperative outcomes. Although the study demonstrated safety and feasibility, it was not powered to detect differences in postoperative outcomes. The impact of vasopressors on postoperative outcomes in patients undergoing complex spinal surgery in the prone position is even scarcer. While it has been demonstrated that the use of intra-operative vasopressor infusion is safe and well tolerated, without any adverse renal outcomes, it is unclear if the choice of vasopressor makes any difference. While animal studies have shown that norepinephrine may provide greater spinal cord protection than phenylephrine, clinical studies in humans are lacking. We aim to fill this gap in knowledge by carrying out a prospective, randomized control trial to evaluate differential outcomes related to the choice of norepinephrine versus phenylephrine as the preferential vasopressor in patients undergoing elective spinal fusion surgery in the prone position.

Eligibility Criteria:
Inclusion Criteria:

-Patients \> 18 years undergoing elective, prone, spinal fusion surgery

Exclusion Criteria:

* Age \< 18 years
* Emergency surgery
* Outpatient surgery
* Pregnancy
* End-stage renal disease requiring dialysis
* Diagnosed myocardial ischemia and/or cardiac revascularization within the past month
Tobacco Assessment and Intervention With Low-Income Persons Living With HIV-AIDS (PLWHA) in Community-Based AIDS Service Organizations

"A treatment session especially for PLWHA to help them discuss and take action about their smoking may be useful."


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older as per self-report;
* English speaking;
* New York or New Jersey State resident;
* HIV-positive serostatus direct referral from a CAB agency staff member, which verifies that the person is an HIV+ client, or by as verified by presentation of medical evidence (i.e.,confirmatory test result, ARV prescription, M11Q form, or lab results);
* Self-report of smoking \> or = to 20 cigarettes (\> or = to one pack) within the prior 7 days;
* To confirm smoking status, the carbon monoxide alveolar breath test must be \> or = to 10 ppm;
* To confirm cognitive functioning, score on the in-person BLESSED Exam must be \< or = to 10;
* Low income, defined by either: 1) Proof of Medicaid insurance, or 2) Self-report of income at 50% or below median income for New York State for New York State residents, or if a New Jersey resident, at or below 50% median income for New Jersey

Exclusion Criteria:

* Presence of current severe psychopathology that would limit study participation (e.g., unstable schizophrenia, bipolar disorder recent changes to medication noncompliance);
* Currently receiving smoking cessation treatment elsewhere.
Duration of P-glycoprotein Inhibition After Oral Administration of HM30181AK Tablet

The purposes of this study are to investigate the duration of P-glycoprotein inhibition after oral administration of HM30181AK tablet in healthy male subject and proper dose of HM30181AK tablet.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy male volunteers aged 20 to 50 years at screening
2. Subjects whose weights are heavier than or equal to 50 kg and ±20% of ideal body weight

   * Ideal body weight = (height cm - 100) x 0.9
3. Subjects who provided written, voluntary informed consent to participate in this clinical trial and to comply the directions including contraception after being fully informed of and understand this trial

Exclusion Criteria:

1. Subjects who have the clinically significant diseases or history in liver, kidney, nervous system, respiratory system, endocrine system, blood tumor and cardiovascular system.
2. History of the gastrointestinal diseases which may affect the absorption of oral drugs (e.g., Crohn's disease) or gastrointestinal operations (excluding simple typhlotomy and hernia repair).
3. The following results in laboratory test

   * AST, ALT \> 1.25 x upper limits of normal
4. Systolic blood pressure below 100 mmHg or above 150 mmHg or diastolic blood pressure below 65 mmHg or above 95 mmHg in vital signs
5. History of drug allergy or other allergies which are clinically significant
6. History of drug abuse or positive reaction for drug abuse in urine screening test
7. Subjects who took prescription drugs or herbal medicines within 2 weeks prior to the first day of drug administration or OTC or vitamin preparations within 1 week prior to the first day of drug administration If the subjects meet other criteria, they could participate in the trial in the judgement of investigator.)
8. Subjects who have participated in other clinical trial within 2 months prior to the first day of drug administration
9. Whole blood donation within 2 months prior to the first day of drug administration or apheresis donation within 2 weeks prior to the first day of drug administration
10. Subject who are continuously drinking alcohol (over 21 units/week) or who cannot quit drinking during clinical trial period
11. Subject who are smoking over 10 cigar/day
12. Subjects who eat food containing caffeine or grapefruit or drink alcohol in prohibited period
13. Subjects who are inappropriate in the judgement of the investigator due to the reasons including clinical laboratory test results
Left Atrial Appendage Arrhythmogenic and Thrombogenic Substrate

The purpose of the project is to elucidate whether it is possible to identify which patients are at risk of forming blood clots that can cause stroke based on analysis of the electrocardiogram.

In connection with the operation, the small pouch known as the auricle of the heart is closed, which can be completely removed after closing. This procedure is common in patients with atrial fibrillation to protect the brain from stroke. In the project, all patients will have this auricle closed if they agree to participate in the project.

After closure, the auricle is usually discarded. We will analyze the blood and the auricle tissue taken (if available) in connection with the operation itself, together with the analysis of the electrocardiogram recorded before the planned heart operation.

Patients scheduled for elective heart surgery are invited to participate. After informed consent is signed, an ECG and blood samples are gathered the day before surgery or the same day of the surgery is planned.

During surgery, the patients undergo closure of the left atrial appendage (LAA). The choice of the device is at the discretion of the surgeon. If possible, the entire LAA is removed and processed for further analysis. The right atrial appendage is likewise removed and follows the same procedure as the LAA.

The analyses include measurement of up-/down-regulated thrombosis factors and inflammatory markers.

The right and left atrial appendage tissue collected are immediately processed for micro-patch-clamp studies, and the remaining tissue is divided into a part that is frozen for later analyses and a part that is fixed and embedded in paraffin for further histological analyses.

Eligibility Criteria:
Inclusion Criteria:

* signed informed consent AND
* planned any open-heart surgery:

  * CABG
  * valve repair or replacement
  * aorta surgery
  * any combination of the above

Exclusion Criteria:

* current endocarditis
* follow-up not possible
Mindfulness Based Relapse Prevention for Stimulant Users

The broad, long-term objective of the current research is to improve treatment for stimulant use disorders by augmenting traditional relapse prevention therapy with innovative meditation-based strategies to promote affect regulation skills. Based on Mindfulness-Based Cognitive Therapy for depression (Segal, Teasdale, \& Williams, 2002), Marlatt and colleagues recently developed a manualized intervention for the treatment of substance using populations: Mindfulness Based Relapse Prevention (MBRP). The specific aims of this research are 1) To conduct a pilot randomized clinical trial to assess the feasibility of recruiting and retaining individuals for a large scale study and to determine the effect size of MBRP relative to a health education (ED) control group in stimulant users receiving contingency management (CM).

Both MBRP and ED participants will be assessed at baseline, treatment-end, and 1 month post-treatment. 2) To test the impact of MBRP compared to ED on negative affect, stimulant use, and health care outcomes. 3) To evaluate the differential effects of MBRP versus ED on HIV-risk behavior of participants, and 4) To examine potential mechanisms of action of MBRP, including reductions in stress reactivity and biological indicators of arousal such as blood pressure and heart rate. The investigators hypothesize that MBRP will be more efficacious than ED in reducing negative affect and stimulant use. Further, the investigators expect that MBRP will produce greater reductions in HIV-risk behaviors, stress reactivity, and arousal, and these changes will be associated with substance use outcomes. MBRP incorporates specific substance-focused cognitive therapy techniques with an additional emphasis on mindfulness skills. By providing coping skills to address affect regulation and stress reactivity, two important factors in stimulant relapse, MBRP may provide a promising augmenting strategy for the treatment of stimulant users.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 to 59
2. DSM-IV diagnosis of Stimulant Dependence
3. Able to provide informed consent
4. Willing and able to participate in study procedures

Exclusion Criteria:

1. Presence of life threatening or unstable medical illness, such as acute pulmonary, cardiovascular, or musculoskeletal disease, that would require treatment or make study participation difficult
2. Lack of proficiency in English
3. Currently homeless (unless residing in a recovery home for which contact information can be provided)
4. Dependence on an illicit substance for which medical detoxification is imminently needed.
5. Presence of clinically significant psychiatric symptoms as assessed by MINI, such as psychosis or acute mania, that would require ongoing treatment or make study compliance difficult.
Performance of the HBV ELISPOT in the Detection of the T Cellular Immune Response in Patients Infected by HBV or Cured

Activation of the immune system against a pathogen can be considered one of the most effective interventions in the field of infectious diseases.

Transgene is developing a therapeutic vaccine "TG1050" for the treatment of patients with chronic and treated Hepatitis B. This biotherapy compound is for the development of T cellular immune response in these patients in order to achieve the total elimination of infected cells.

Therefore it is necessary to have measures of ways to assess accurately and reliably the presence of such a response in the study subjects.


Eligibility Criteria:
Inclusion Criteria:

Man or woman aged ≥18 years old.

Patients with chronic hepatitis B regardless of the genotype.

* treated with nucleotide analogs approved for the treatment of hepatitis B.
* or untreated.
* with a positive or negative antigen HBe
* regardless of the level of transaminases.

Patients with a history of HBV infection (recovered) with seroconversion of antigen HBs spontaneously or under treatment.

Patient with a general state ranging 0 or 1 on the ECOG scale (Eastern Cooperative Oncology Group)

Patient who signed the informed consent

Patient with a social security affiliation

Exclusion Criteria:

patients co-infected with human immunodeficiency virus (HIV) or Hepatitis C virus (HCV).

Patients treated with interferon, immunosuppressive, or experimental treatment consisting of an unapproved molecule for the treatment of hepatitis B.

Patient unable to meet the constraints of the study

Patient transplanted

Patient with a history of cancer or autoimmune disease within 5 years

Pregnant or lactating women