cyrilzakka/clinical-trials huggingface dataset:
Registry of COVID-19 Patients Treated With the Seraph 100 Microbind Affinity Blood Filter

The purpose of this registry study is to investigate the effectiveness and safety of the Seraph® 100 Microbind® Affinity Blood Filter (Seraph 100) in the treatment of COVID-19 patients.

During the ongoing COVID-19 pandemic, millions of people have been infected with SARS- Cov-2 worldwide. In the absence of an approved vaccine or medical treatment, there is an emerging need for treatment options, especially in critically ill patients. Multiple pharmacological and non-pharmacological therapies are being investigated. In 2019, the Seraph® 100 Microbind® Affinity Blood Filter (ExThera Medical Corporation, CA, USA) was approved for the removal of pathogens in Europe. On April 17th the FDA granted Authorization for Emergency Use in patients with COVID-19 admitted to the ICU with confirmed or imminent respiratory failure.

Eligibility Criteria:
Inclusion Criteria:

* COVID-19 infection
* Treatment with the Seraph® 100 Microbind® Affinity Blood Filter
* Voluntary consent to participate in Registry

Exclusion Criteria:

- none
Targeting Inflammation in Acute Coronary Syndrome Using Colchicine

The purpose of this study is to evaluate the effect of colchicine on high sensitivity C-reactive protein (hs-CRP), a blood marker to measure inflammation, in patients with acute coronary syndromes.


Eligibility Criteria:
Inclusion Criteria:

* All patients with a diagnosis of acute coronary syndrome who are \> 18 years old and who do not have any contraindication to colchicine.

Exclusion Criteria:

* Contraindication to colchicine including any of the following:

  * hypersensitivity to colchicine
  * severe renal, hepatic or gastrointestinal disorder
  * blood dyscrasias (myelodysplasia cytopenias etc)
* Concurrent use of moderate-strong CYP3A4 inhibitors (a complete list is appended in the full protocol)
* Known severe liver disease and/or elevated transaminases \> 1.5x the upper limit of normal
* Estimated GFR \< 50 ml/min
* Pregnant or lactating women or women not protected by a reliable contraception method
* Current treatment with colchicine at enrollment
* Active infection or systemic inflammation eg active rheumatoid arthritis
Online Emotional Regulation Group Treatment

This study will examine the feasibility of online delivery of emotional regulation training to individuals with TBI with emotional dysregulation. 80 subjects with significant emotional dysregulation will be enrolled and will receive 24 60-minute emotional regulation sessions twice a week for 12 weeks, delivered online in group modality. Attendance and compliance will be tracked, and outcomes will be monitored using online data collection methods. Treatment satisfaction and participant subjective experience will also be assessed.

This study will examine the feasibility of online delivery of emotional regulation training to individuals with Traumatic Brain Injury who also have emotional dysregulation. 80 subjects with significant emotional dysregulation will be enrolled and will receive 24 60-minute emotional regulation sessions twice a week for 12 weeks, delivered online via a group meeting software. Study participation will last 28 weeks: 4 weeks of baseline, 12 weeks of treatment (24 sessions) and 12 weeks of follow-up. Assessments will be conducted at each of four timepoints: T1 (baseline), T2 (pre-treatment assessment), T3 (end-of-treatment assessment) and T4 (follow-up assessment). In addition, a subset of the measures will be administered bi-weekly for the duration of the study. Assessments will consist of a variety of measures designed to measure executive functioning, problem solving skills, and quality of life. All assessments will be completed online, using a web-based data collection. Attendance and treatment compliance will be tracked, and outcomes will be monitored using online data collection methods. Treatment satisfaction and participant subjective experience (including technical difficulties that make access to web-delivered treatment impossible) will also be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Documented TBI of any severity and being at least 6 months post injury
* Presence of executive dysfunction, manifested as self-reported difficulties with emotional and behavioral self-regulation, operationalized as endorsement of 25% or more of the symptoms on the Difficulties in Emotion Regulation Scale (DERS, Gratz \& Roemer, 2004).
* Currently aged 18 or older
* English speaking
* At least low average intellectual functioning, operationalized as a minimum Verbal IQ score of 80 on the Wechsler Abbreviated Scale of Intelligence
* Ownership of and relative facility with use of a computer, webcam, and microphone
* Access to a broadband internet connection at sufficiently high speed to allow videoconference

Exclusion Criteria:

* DSM-IV-TR diagnosis of alcohol or substance abuse within past 6 months
* DSM-IV-TR of psychosis within past 6 months
* High suicidality, operationalized as a score of 17 or higher on the Mini International Neuropsychiatric Interview (M.I.N.I., Sheehan et al., 2008)

Participation in this study will not preclude participation in other treatments.
The 90% Effective Dose of Remimazolam for Duodenoscopy Insertion During ERCP With Alfentanil 10µg/kg

Remimazolam has shown promising results for sedation in colonoscopy . Alfentanil is widely used in the analgesia of ERCP . The purpose of the study was to determine the 90% Effective Dose of Remimazolam for Duodenoscopy Insertion During ERCP With Alfentanil 10µg/kg

1. Title:The 90% Effective Dose of Remimazolam for Duodenoscopy Insertion During ERCP With Alfentanil 10µg/kg 2. Research center: Single center. 3. The population of the study: Age is between 18 and 85 years; ASA I-III levels; Patients undergone elective ERCP surgery, non-intubation patients; 4. Sample size:The sample size was decided based on that of prior Literature.The study was carried out using a biased coin design up-and-down sequential method, where the dose of remimazolam administered to each patient depended on the response of the previous one with success/failure duodenoscopy insertion during ERCP are required for reliable estimates. The first patient recruited received a dose of 0.2mg/kg, based on our past experience.Subsequently, if a patient had a failure duodenoscopy insertion, the dose of remimazolam was increased by 0.025mg/kg in the next subject. If a patient had a successful duodenoscopy insertion the next subject was randomised to receive either a lower dose (with a decrement of 0.025mg/kg), with a probability of b = 0.11, or the same dose, with a probability of 1-b = 0.89.

We defined duodenoscopy insertion a failure was as gross purposeful muscular movement, coughing or vomiting occurring during or within 2 minutes of insertion of duodenoscopy. If BIS\>75 and MOAA/S \> 1 when 3 min after the intravenous injection of remimazolam, it was considered a failure, and the patient received rescue sedation. Success was depicted when the reactions mentioned earlier were absent.

Eligibility Criteria:
Inclusion Criteria:

* Age is between 18 and 85 years
* ASA I-III levels;
* Patients undergone elective ERCP surgery, non-intubation patients;

Exclusion Criteria:

* Chronic pain with long-term use of analgesics, psychotropic substances (including opioids, NSAIDs, sedatives, antidepressants), alcohol abusers, with known drug allergy;
* BMI\<18 or BMI\>30;
* Previous abnormal surgical anesthesia recovery history;
* Hypertension or systolic blood pressure greater than 160 mmHg or diastolic blood pressure greater than 95 mmHg when the patient admission to the operating room
* Suffering from esophageal reflux; • Sedatives, analgesics and antipruritic drugs were used 24 hours before operation;
* Expected difficult intubation ;
* Opioids allergy history;
* Take monoamine oxidase inhibitor or antidepressant within 15 days;
* Pregnant or parturient women;
* Involved in other drug trials within three months;
* Patients who can not communicate well with the researcher
B-TURP vs BipolEP in Management of BPH Patients With Medium-sized Prostates

This is a comparative study of the efficacy and safety of endoscopic bipolar transurethral resection and enucleation of the prostate in management of benign prostatic hyperplasia patients with medium-sized prostates

Benign prostatic hyperplasia (BPH) is a highly prevalent condition among aging males, with incidence rates escalating progressively with age. Epidemiological data indicate that approximately 8% of men in their fourth decade are affected, a proportion that rises to 50% by the sixth decade and exceeds 80% in individuals reaching their ninth decade. BPH may induce bladder outlet obstruction (BOO), leading to lower urinary tract symptoms (LUTS). LUTS are one of the most frequent urological complaints in aging males. LUTS are typically categorized into obstructive and storage subtypes, with clinical BPH representing the predominant underlying etiology.

Approximately 20% of men with BPH will eventually require surgical intervention. Transurethral resection of the prostate (TURP) remains the gold-standard surgical treatment, offering both immediate relief of intravesical obstruction and durable improvement in voiding parameters and symptoms. However, the procedure carries significant risks, including perioperative bleeding and transurethral resection syndrome (TUR syndrome), with complication rates increasing proportionally to prostate size.

The recent technological advancements in urological equipment have led to increased adoption of bipolar transurethral resection of the prostate (B-TURP) for BPH management. This technique employs a plasma kinetic system that provides superior coagulation capabilities. A significant advantage of B-TURP is its use of normal saline irrigation, which substantially reduces the risk of TUR syndrome compared to conventional methods. Clinical studies have demonstrated B-TURP's efficacy in relieving bladder outlet obstruction secondary to BPH, with outcomes comparable to traditional approaches.

Despite advancements in TURP technology, incidence of complications such as postoperative recurrence remained unchanged, necessitating surgical innovation. In this context, bipolar enucleation of the prostate (BipoLEP) has emerged as an alternative technique designed to address these challenges. Our study was designed to conduct a comparative analysis of BipoLEP versus bipolar B-TURP in the treatment of medium-sized BPH patients.

Eligibility Criteria:
Inclusion Criteria:

* Male patients aged 45-80 years with symptomatic BPH (IPSS ≥8).
* Prostate volume between 40-80 cc as determined by transrectal ultrasound (TRUS).
* Failure of medical management.
* Written informed consent.

Exclusion Criteria:

* Prostate cancer (suspected on PSA/DRE or confirmed by biopsy).
* Previous prostate/urethral surgery.
* Neurogenic bladder or urethral strictures.
* Significant coagulopathy.
* Uncontrolled urinary tract infection.
* Patient on anticoagulant medication.
Sexual Absorption of Vaginal Progesterone

The purpose of this study is to determine if sexual intercourse lowers serum progesterone in women using vaginal progesterone gel (Crinone®), and increases serum progesterone in their male sexual partners. We hypothesize, based on previous estrogen studies done by our group, that intercourse will interfere with absorption of vaginal progesterone.

The effects of intercourse on the absorption of vaginal progesterone for the female user and her sexual partner have not been studied. However, a previous study performed by our group found that intercourse lowered the absorption of vaginal estrogen cream in women, and men absorbed a small but statistically significant amount of estradiol during intercourse. Vaginal progesterone gel may be used by women for several clinical indications, and if intercourse alters the absorption and distribution of vaginal progesterone, clinical outcomes may be compromised. If intercourse lowers absorption, the efficacy of the treatment could be reduced. If intercourse enhances absorption, side effects may be increased. Also, if the male sexual partner absorbs vaginal progesterone, undesirable side effects may occur.

Eligibility Criteria:
Inclusion Criteria:

* Sexually active 18-40 year old heterosexual couple
* Subject willing to take Mircette birth control pills for at least one cycle (one pack)
* Willing to have intercourse at the defined times (at least weekly within a 3 week interval, and draw blood within 10 hours of intercourse)
* IRB signed informed consent

Exclusion Criteria:

* Undiagnosed vaginal bleeding
* Contraindication to oral contraceptives
* Liver dysfunction or disease
* Known sensitivity to Crinone
* Known or suspected malignancy of the breast or genital organs
* History of or active thrombophlebitis or thromboembolic disorders
* Use of condoms during intercourse
* Male erectile or ejaculatory dysfunction
A Comparison of Morbidity Between Patients With Pulmonary Atresia With Intact Ventricular Septum and Uni- or Biventricular Circulation

The goal of this observational study is to compare patients with pulmonary atresia with intact ventricular septum (PA-IVS) with univentricular circulation to patients with the same heart defect but that has a biventricular circulation in regards to mortality, quality of life, comorbidity, cardiac function, and work capacity. The main questions the study aims to answer are:

• Do mortality, quality of life, comorbidity, cardiac function, and work capacity differ between patients with PA-IVS who have univentricular and biventricular circulation?

Participants will be asked to answer a Quality of Life questionnaire. The investigators will also inquire with a sample size of the research subjects (based on place of residence) about their participation in a series of examinations (ergo-spirometry to assess work capacity, transthoracic echocardiogram, magnetic resonance of the heart and blood sampling to assess cardiac function and cardiac health).


Eligibility Criteria:
Inclusion Criteria:

* Individuals born with pulmonary atresia with intact ventricular septum (PA-IVS) who are 15 years or older at the start of the study.
* Regarding the mortality variable, research subjects who have died after the age of 15 years old will be included.

Exclusion Criteria:

Individuals born with pulmonary atresia with intact ventricular septum who are younger than 15 years old at the start of the study.
Insulin Like Growth Factor-1 Against Oxidative Stress in Vitiligo

Insulin like growth factor has a protective role on melanocytes against the oxidative stress. The aim is to investigate this effect in vitiligo patients.


Eligibility Criteria:
Inclusion Criteria:

* Non-segmental vitiligo

Exclusion Criteria:

1. Pregnant or lactating females
2. Smokers
3. Patients with any endocrinal disease known to affect GH or IGF-1 as Diabetes (by measuring HbA1c) and Thyroid disturbance (by measuring TSH)
4. Patients with liver disease (by measuring AST, ALT and GGT)
5. Obese patients (by measuring BMI)
6. Patients with history of ischemic heart disease (known medical history of angina or myocardial infarction or history of recurrent chest pain, left shoulder pain, shortness of breath or fatigue on the ordinary effort or less than the ordinary effort )
7. Patients with history of Peripheral arterial disease (Known medical history of peripheral arterial thrombosis or history of recurrent claudications)
8. Patients with history of cerebero-vascular disease (known medical history of transient ischemic attacks or stroke)
9. Patients who received systemic treatment for vitiligo during the previous six months or topical treatment during the previous two months
Single Dose and Multiple Dose Safety, Tolerability, PK，and Food Effect Study，and Interaction With Oseltamivir Study of HEC116094 in Healthy Adult Subjects

The Safety, Tolerability, Pharmacokinetic, Food Effect Study and the interaction with Oseltamivir Phosphate Capsules of HEC116094 in Healthy Subjects


Eligibility Criteria:
Inclusion Criteria:

* Willing to participate in the study, able to understand and sign the informed consent, and able to complete the the study in accordance with the requirements of the study.
* Female subjects who are not pregnant or lactating and male subjects whose female partners are fertile shall voluntarily take effective contraceptive measures from the date of signing the informed consent form to 3 months after the medication.
* When signing the informed consent, 18 years old ≤the age≤45 years old(including the critical value), gender is not limited.
* Male body weight ≥50kg, female body weight ≥45kg, and body mass index (BMI) in the range of 18-28 kg/m2 (including the critical value).
* No clinical significance of vital signs, physical examination, laboratory examination, electrocardiogram, ultrasound abdomen and chest X-ray (posterior and anterior) results.

Exclusion Criteria:

* Positive for Viral hepatitis (including hepatitis B and C), HIV and syphilis.
* Those who are known to have allergy history or allergy constitution to the test preparation and any of its components or related preparations.
* Consume foods or beverages containing caffeine, xanthine, alcohol, and grapefruit within 48 hours prior to initial dosing.
* Positive results from urine drug screen test.
* Donate blood or lose blood 400 mL or more within 1 month prior to initial dosing.
* Subjects who plan to receive or have had organ transplants.
* Subjects considered by the investigator to have other factors unsuitable for participation in this study.
Acupuncture for Primary Insomnia

This is a randomized controlled trial to evaluate acupuncture treatment on insomnia in the adult population in Hong Kong.

Acupuncture is potential to be an alternative treatment for primary insomnia. The purpose of this study is to evaluate the clinical effectiveness of acupuncture treatment on primary insomnia. This is a randomized single-blinded controlled trial. Patients will be randomly assigned to the electro-acupuncture group or the placebo acupuncture group. Patients will be put into groups and then compared.

Eligibility Criteria:
Inclusion Criteria:

* Hong Kong residents
* aged 18-65
* Ethnic Chinese
* Meet the diagnosis criteria of primary insomnia for at least 3 months according to DSM-IV using the Structured Clinical Interview for DSM-IV (SCID)
* Willing to give informed consent
* total score of Insomnia Severity Index (ISI) at least 15
* Able to comply with trial protocol

Exclusion Criteria:

* Participation in any clinical trial during the previous 3 months prior to baseline
* Any current major depressive disorder, generalized anxiety disorders or panic disorder, manic or hypomanic episode, substance use disorders besides caffeine and nicotine, organic mental disorder, schizophrenia or any other psychotic disorder as defined by DSM-IV criteria
* Serious physical illness or mental disorders due to a general medical condition which is judged by the investigator to render unsafe
* Valvular heart defects, bleeding disorders or taking anticoagulant drugs.
* Any acupuncture treatment during the previous 12 months prior to baseline.
* In the investigator's opinion, the patient has a significant risk of suicide
* Pregnant, breast-feeding, or woman of childbearing potential not using adequate contraception
* Infection or abscess close to the site of selected acupoints and in the investigator's opinion inclusion is unsafe
* Herbal remedies, over-the-counter medications or psychotropic drugs, which are intended for insomnia, were taken within the last 2 weeks prior to baseline or during the study
Evaluation of Diolaze XL Blended Mode for Hair Removal

The objective of this clinical study is to evaluate safety and efficiency of Diolase XL blended modes for hair removal. The handpieces tested were a blend of 755nm/810nm and 810nm/1064nm. At least 30 female subjects seeking hair removal treatment will be enrolled. Treatment sites will be o groins and axillae. Study design included 3 treatment sessions 4 weeks apart and follow-up after 3 months.


Eligibility Criteria:
Inclusion Criteria:

* Adult females between the ages of 18-65, seeking hair removal treatments.
* Subjects skin type II-V.
* Subjects should understand the information provided about the investigative nature of the treatment, possible benefits and side effects, and sign the Informed Consent Form, (including the permission to use photography).
* Subjects should be willing to comply with the study procedure and schedule, including the follow up visit, to refrain from using any other aesthetic treatment methods in the treatment areas such as other hair removal methods (wax, IPL, laser), Botox or other technologies for hyperhidrosis or rejuvenation for the last 6 months and during the entire study period and to remain unshaven for a minimum of 3 days before their visit.

Exclusion Criteria:

* Current or history of skin cancer, or current condition of any other type of cancer, or pre-malignant moles.
* Pregnancy and nursing.
* Impaired immune system due to immunosuppressive diseases such as AIDS and HIV, or use of immunosuppressive medications.
* Patients with history of diseases stimulated by heat, such as recurrent Herpes Simplex in the treatment area, may be treated only following a prophylactic regimen.
* Poorly controlled endocrine disorders, such as diabetes, thyroid dysfunction, polycystic ovary and hormonal virilization.
* Any active condition in the treatment area, such as sores, psoriasis, eczema, and rash.
* History of skin disorders, keloids, abnormal wound healing, as well as very dry and fragile skin.
* Severe concurrent conditions, such as cardiac disorders, sensory disturbances.
* Use of Isotretinoin (Accutane®) within 6 months prior to treatment.
* Known skin photosensitivity or using drugs increasing skin photosensitivity.
* Diseases that may be stimulated by light, such as epilepsy, lupus and urticaria.
* Six months delay is recommended if other recent treatments like light, laser or RF were performed on the same area.
* Treating over tattoo and permanent make-up.
* Fresh tan from sun, sunbeds or chemicals or planned excessive sun exposure.
* Vitiligo.
* As per the practitioner's discretion, refrain from treating any condition which might make it unsafe for the patient.
Efficacy of Metformin and Diane-35 on PCOS Patients,a Randomized, Controlled, Prospective Clinical Trial

Polycystic ovary syndrome (PCOS) is one of the most common endocrinopathies in reproductive-age women, and it affects 5-7% of this group. It is characterized by disturbed menstrual cycle, ovulatory dysfunction and hyperandrogenism. Over 40% of PCOS women might become the patients with impaired glucose tolerance or type 2 diabetes. It has been confirmed that insulin resistance (IR) is a common feature in PCOS and adipokines might play roles in the pathogenesis of IR and PCOS, because these adipokines have wide-ranging effects on carbohydrate and lipid metabolism.

The present clinical trial intends to compare the effects of metformin and oral contraceptives on PCOS patients, focusing on the insulin sensitivity, ovulation, and menstrual cycle etc. The investigators also aim to study the effects of metformin on serum adipokine levels(such as pigment epithelium-derived factor, progranulin etc.)in PCOS patients.


Eligibility Criteria:
Inclusion Criteria:

with at least two of the following features : (i) oligo-amenorrhea or chronic anovulation; (ii) clinical and/or biochemical hyperandrogenism; (iii) ultrasound appearance of polycystic ovaries

Exclusion Criteria:

- other known causes of hyperandrogenemia and ovulatory dysfunction, including 21-hydroxylase deficiency, congenital adrenal hyperplasia, Cushing's syndrome, androgen-secreting tumors, thyroid disease, and hyperprolactinemia.

use of hormone medications (including oral contraceptives) within the past month and the use of medicines that affect insulin sensitivity (e.g., metformin or thiazolidinediones) within the past three months