cyrilzakka/clinical-trials huggingface dataset:
Chinese Medicine Periodic Therapy for Dysfunctional Uterine Bleeding During Adolescence With Yin Deficiency and Blood Heat Syndrome

The purpose of this study is to conduct a randomized, single blind, controlled intervention trial to observe the therapeutic effect of kidney-tonifying and tune up Chong-Ren hemostasis Chinese medicine periodic therapy for dysfunctional uterine bleeding based on objective Chinese and western medicine evaluation standard.

Dysfunctional uterine bleeding during adolescence is the most common menstrual disorders during adolescence, and the age of children suffering from it tended to be lower. It's urgent to explore effective ways to alleviate the pain caused by dysfunctional uterine bleeding.

In our research, 160 children are randomly divided into a Chinese medication periodic therapy group (80 cases) and a Gong Xue Ning control group (80 cases). Paticipants in Chinese medication periodic therapy group are treated with kidney-tonifying and tune up Chong-Ren hemostasis Chinese medicine for 3 months, whereas the Gong Xue Ning control group received Gong Xue Ning capsules for 3 months. We compare the effect of the two therapies about hemostasis and menstruation regulation, and the change of the thickness of endometrium, sex hormones, Kisspeptin, and PAI-1 in blood before and after the treatment, in order to make clear the efficacy and the mechanism of the Chinese medicine periodic therapy.

Eligibility Criteria:
Inclusion Criteria:

* satisfy the diagnostic criteria in the textbook\<Obstetrics and Gynecology\> with dysfunctional uterine bleeding
* age between 10-18 years
* course of the disease is 2 months or more.

Exclusion Criteria:

* have uterine bleeding on account of systemic diseases or organic diseases in reproductive system, such as blood diseases, thyroid diseases, hepatic diseases, etc.
* HB\<80g/L
* have mental disorders
* allergic to many kinds of drugs
Physical Activity, Psychopathology, and Quality of Life in People With Psychotic or Affective Disorders

This longitudinal observational study tests the associations between physical activity, health-related quality of life, and psychopathology symptoms among people diagnosed with schizophrenia or diagnosed with affective disorders. It was assumed that higher levels of physical activity at baseline will be related to better quality of life (across physical, social, and psychological domains), and lower psychopathology symptoms (positive and negative symptoms of psychosis, general psychopathology, and depression severity) at 6-week follow-up measurement. Adult participants with a diagnosis of a psychotic disorder or a diagnosis of an affective disorder will be enrolled.


Eligibility Criteria:
Inclusion Criteria:

- a diagnosis of a psychotic disorder or affective disorder

Exclusion Criteria:

* major cognitive deficits, indicated by total scores \> 8 points, obtained with the Montreal Cognitive Assessment (MoCA) Scale at baseline
Vestibular Socket Therapy (VST) Versus Partial Extraction Therapy

The current randomized clinical trial aimed to compare the VST versus Partial Extraction Therapy (PET) for immediate implant placement in the esthetic zone in class I fresh extraction sites.

The primary outcome was the assessment of vertical dimensional changes in peri-implant soft tissue margin.

The secondary outcome was the assessment of radiographic changes in the thickness of the facial peri-implant tissues.


Eligibility Criteria:
Inclusion Criteria:

* single hopeless maxillary tooth in the esthetic zone
* non-smokers
* systemically healthy
* Class I extraction sites

Exclusion Criteria:

* smoking
* Class II and III extraction sites
* hopeless teeth with acute infection or vertical/horizontal root fracture
Clinical Usefulness of Virtual Ablation Guided Catheter Ablation of Atrial Fibrillation: Virtual Rotor Mapping and Catheter Ablation

Radiofrequency catheter ablation is effective in the treatment of patients with paroxysmal atrial fibrillation. In order to reduce the recurrence rate after catheter ablation, the investigators propose to apply 'virtual' ablation on patient-specific atria by simulating 3D atrial computer model. The investigators will conduct virtual rotor mapping in the patient specific atrial model. Then, the investigators will compare the clinical outcome of conventional circumferential pulmonary vein isolation and additional rotor ablation guided by virtual rotor mapping.


Eligibility Criteria:
Inclusion Criteria:

* AF patient age 19\~80
* Diagnosis of AF patients who performed catheter ablation of atrial fibrillation due to uncontrolled pulse rate by anti-arrhythmic drug therapy.

Exclusion Criteria:

* AF patients who have severe heart deformations or vascular disease.
* The patient who have renal disease of eGFR\<30mL/min
* The patients who had been performed catheter ablation of atrial ablation and MAZE.
* The patients who missed out to recording of 3D CT, echo and electrocardiography.
* the patient have experienced major hemorrhagic complication
* The patient have experienced ischemic cerebral infarction more 2 times
* The patient who have risk of ischemic cerebral infarction (CHA2DS2-VASc Score \>5)
Lentiviral FIX Gene Therapy

This study is a Phase I trial using an advanced lentiviral vector to deliver a functional gene for human clotting factor IX into patients with hemophilia B, to evaluate the safety and efficacy of infusion of lentiviral gene modified autologous stem cells in patients.

Hemophilia B is a genetic bleeding disorder caused by the lack of ability to produce blood-clotting factor IX (FIX). Individuals with hemophilia B suffer repeated bleeding episodes, which can cause chronic joint disease and sometimes even death due to the inability for blood to clot efficiently. The current treatment is intravenous infusion of clotting factor concentrates, either prophylactically or in response to bleeding. The procedure is life time long and expensive while still cannot achieve a cure.Gene therapy is a novel technology that has been successfully demonstrated in a number of clinical studies for diseases such as cancer and genetic diseases. In this study, an advanced lentiviral vector system NHP/TYF will be used to deliver a functional FIX gene to overcome human clotting FIX gene defect in patients with hemophilia B. This study is a Phase I trial evaluating the safety and efficacy for infusion of gene modified autologous stem cells in patients with hemophilia B.

Eligibility Criteria:
Inclusion Criteria:

* 1. Able to provide informed consent and comply with requirements of the study. 2. Males ≥2 years with confirmed diagnosis of hemophilia B (endogenous factor IX ≤2 IU/dL or ≤2% of normal).

  3. A minimum average of 4 bleeding events per year requiring episodic treatment of factor IX infusions or prophylactic factor IX infusions.

  4. No measurable factor IX inhibitor as assessed by the central laboratory and have no prior history of inhibitors to factor IX protein.

  5. Agree to use reliable barrier contraception until 3 consecutive samples are negative for vector sequences.

Exclusion Criteria:

* 1. Significant liver dysfunction as defined by abnormal alanine transaminase, bilirubin and alkaline phosphatase.

  2. History of inhibitor against factor IX. 3. Evidence of active hepatitis B or C and currently on antiviral therapy. 4. Have serological evidence of HIV-1 or HIV-2 with CD4 counts ≤200/mm3 (subjects who are HIV+ and stable with CD4 count \>200/mm3 and undetectable viral load are eligible to enroll).

  5. Any evidence of active infection or any immunosuppressive disorder. 6. Participated in a gene transfer trial within the last 6 months or in a clinical trial with an investigational drug within the last 12 weeks.

  7. Unable or unwilling to comply with study assessments.
Parasternal Block Combined With Rectus Sheath Block for Cardiac Surgery Under Sternotomy

The aim of this randomized controlled trial is to examine the effect of ultrasound guided bilateral Parasternal Nerve Block combined with rectus sheath block on preoperative analgesia, opioid consumption and respiratory function in patients undergoing cardiac surgery via sternotomy. Half of participants will receive General Anesthesia combined with bilateral parasternal block and rectus sheath block while the other half receive General Anesthesia combined with bilateral parasternal block and infiltration of drainage exits sites with local anesthetic (without performing rectus sheath block)


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing elective cardiac surgery under median sternotomy
* Age \>= 18 years
* American Society of Anesthesiologists (ASA) Status I-IV
* Approval and sign of the informed consent

Exclusion Criteria:

* Allergy to local anesthetics
* Puncture site infection
* Lack of signing of informed consent
* Age \<18 years
* Emergency surgery
* ASA \> IV
* preoperative acute respiratory failure
Double-bundle Versus Single-Bundle Anterior Cruciate Ligament Reconstruction

The purpose of this study is to compare double-bundle and single-bundle techniques for ACL reconstruction in a long-term 15-year follow-up. Our hypothesis is that the DB technique is better than the SB technique.


Eligibility Criteria:
Inclusion Criteria:

* To be eligible for the study, patients had to meet certain criteria, including primary ACL reconstruction, closed growth plates, and no ligamentous injuries to the contralateral knee.

Exclusion Criteria:

-
Taping to Control Edema in Patients With Forearm Plaster for Wrist Fracture.

Wrist fractures are a very common event affecting patients of all ages and are estimated to account for approximately 10% -25% of all fractures. 70-90% of fractures are treated with closed reduction and forearm cast. In 2019, 17.4% of wrist fractured patients treated with a plaster cast at the Orthopedic Emergency Department (OED) of the Local Health Unit ("Azienda Unità Sanitaria Locale", AUSL) of Piacenza had a second access to the OED for edema, pain or "intolerance to the plaster cast ".

In literature, there are several studies that demonstrate the effectiveness of adhesive elastic tape for edema control, mostly lymphedema secondary to breast cancer or post-operative edema after knee arthroplasty, although a definitive evidence is still needed.

With this trial, the investigators aim to evaluate the tape effectiveness in counteracting hand edema formation in wrist fractured adult patients treated with forearm cast.


Eligibility Criteria:
Inclusion Criteria:

* Patients with growth plates closed on radiographic examination
* Unilateral distal radius fracture associated or not with ulnar styloid fracture
* Wrist fracture requiring bloodless reduction and immobilization with a forearm cast

Exclusion Criteria:

* Patients with multiple fractures
* Polytrauma patients
* Patients with previous plegia / paralysis of the fractured limb
* Patients with previous lymphedema of the fractured limb
* Patients with access to the OED during the night when the organization does not guarantee the presence of 2 nurses
* Wounds or abrasions in the area of application of the tape
* Acute thrombosis (upper limb veins)
* Scars not perfectly healed in the area of application of the tape
* Dermatitis, psoriatic manifestations or erythema in the area of application of the tape
* Known allergy to acrylic (patch glue)
* Solid neoplasms
A Study to Evaluate the Safety and Efficacy of VGB-R04 in Adult Hemophilia B Patients

A multicenter, open, non-randomized, phase I/II, two-phase clinical study. The dose exploration phase was phase I, and the dose extension phase was phase II.

Hemophilia B is a genetic bleeding disorder caused by pathogenic variants (eg, mutations, deletion) in the FIX gene. HB patients have frequent and potentially life-threatening bleeding and often develop progressive physical disability and pain from chronic haemarthropathy. Current replacement therapy needs regular treatment in the life-long time, bringing heavy economic and social burdens.

VGB-R04 is a novel AAV vector carrying a high specific activity factor IX variant. This study is intended to evaluate the safety, tolerability and efficacy of a single IV infusion of VGB-R04. All subjects in this study will provide informed consent and then undergo screening assessments up to 6 weeks before administration of VGB-R04. All subjects will undergo 52 weeks of safety observation and will be encouraged to enroll in an Long-term follow-up study to evaluate the long-term safety of VGB-R04 for a total of five years.

Eligibility Criteria:
Inclusion Criteria:

1. Male ≥18 years and ≤65years of age;
2. Confirmed diagnosis of hemophilia B (baseline FIX activity ≤ 2% of normal);
3. At least 100 days exposure history to FIX;
4. Currently receiving FIX Prophylaxis therapy or on-demand treatment to prevent bleeding;
5. Have acceptable laboratory values:

   1. Hemoglobin ≥110 g/L;
   2. Platelets ≥100×109 /L;
   3. AST, ALT, alkaline phosphatase ≤2×upper limit of normal (ULN) at the testing laboratory;
   4. Bilirubin ≤3× ULN ;
   5. Creatinine ≤1.5× ULN.
6. No measurable factor IX inhibitor as assessed by the central laboratory and have no prior history of inhibitors to factor IX protein;
7. Agree to use reliable contraception until 2 consecutive samples are negative for vector sequences;

Exclusion Criteria:

1. Have significant underlying liver disease within the past 6 months prior to or at Screening, including but not limited to:

   1. Preexisting diagnosis of portal hypertension;
   2. Splenomegaly;
   3. Encephalopathy;
   4. Reduction of serum albumin;
   5. Evidence of significant liver fibrosis;
2. Have anti-VGB-R04 neutralizing antibody titers ≥1:5;
3. Evidence of severe infection disease, i.e., human immunodeficiency virus (HIV) infection, syphilis, tuberculosis, etc.;
4. Novel coronavirus infection occurred in the 6 weeks prior to entry into the group
5. Evidence of active hepatitis B virus infection (HBsAg positive) or hepatitis C virus infection (HCV-RNA positive);
6. Evidence of malignant tumours or those with a previous history of malignant tumours;
7. Have a history of chronic infection or other chronic diseases that the Investigator considers to constitute an unacceptable risk;
8. Any immunodeficiency;
9. planned surgery may be required within one year;
10. Past thromboembolic events (arterial or venous thromboembolic events);
11. Hypertensive patients with poor blood pressure control (systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥90mmHg after antihypertensive drug treatment);
Attitudes Towards Deprescribing Medications in Cancer Patients and Impact of Educational Intervention by a Clinical Pharmacist

Your participation in this study consists in responding to some questions from two questionnaires in Romanian about how you feel about deprescribing, your treatment and how you understand medical information. After that, you'll receive a brochure and watch a video with some basic information about medications and your involvement in treatment decisions and in the next visit for your cancer treatment you will be asked to answer questions from one of the initial questionnaire.

Cancer patients are susceptible to using a lot of medications, with an increased risk of drug-related problems that could lead to adverse reactions from oncological drugs, hospital admissions, deteriorated performance status and increased mortality. In time, some medications may no longer be efficient, may have adverse reactions or may lose their indication and need to be stopped or replaced. This process is named deprescribing and it's supervised by a health care professional. Deprescribing can't be done without the implication of the patients, that's why it's important to investigate cancer patient's attitudes towards deprescribing non-oncologic medications in Romanian patients using a validated questionnaire (rPATD). Recent studies from Romania showed a possible lack of health care literacy that could affect patients involvement in treatment decision. In this study, we will investigate health care literacy using a validated questionnaire in Romanian (HLS-EU-Q16). In this study we will also investigate if an educational intervention (targeting patients involvement in treatment decision and mandatory, minimal information about efficacy of a treatment and its adverse reactions) conducted by a clinical pharmacist using a brochure and a video will improve their engagement and knowledge about drugs. Impact of educational intervention will be investigated by applying the rPATD questionnaire before and after the intervention.

Eligibility Criteria:
Inclusion Criteria:

* cancer patients in palliative treatment
* ECOG 1-2

Exclusion Criteria:

* cancer patients in curative treatment
* ECOG 3-4
* cognitive impairment
Multipolar Mapping and Atrial Arrhythmias

This clinical investigation utilizes the Constellation Full Contact Mapping catheter in the left and right atria to explore atrial signal characteristics that can guide atrial fibrillation and atrial flutter ablation procedures more effectively.

Atrial fibrillation (AF) and atrial flutter (AFL) are the most common cardiac arrhythmias in adults, and account for a substantial portion of patient morbidity and healthcare expenditures. Great effort has been put forth to discover effective treatments for AF/FL. Promising results of catheter ablation suggest that AF/FL may be eliminated in a majority of patients. For example, data from numerous laboratories shows that up to 85 percent of patients with the paroxysmal form of AF may be free of recurrences and off anti-arrhythmic drugs at one year follow-up.

Eligibility Criteria:
Inclusion Criteria:

Patients referred to the PI (Dr. Biviano) or co-investigators in the Program of Cardiac Electrophysiology at Columbia University Medical Center who are scheduled to undergo ablation will be approached for recruitment:

* Older than 45 years of age
* History of AF and/or AFL and are candidates for catheter ablation.

Exclusion Criteria:

Patients not fitting the above clinical criteria or unwilling to comply with the instructions of the monitor are excluded, as well as patients with the following:

* Permanent leads or prosthetic or stenotic valves present
* Active systemic infection
* Echocardiographically-confirmed visual presence of thrombus
* For whom the inability of obtaining vascular access exists
* Heparin-induced thrombocytopenia
* Hemodynamic instability or shock
Short Peptide Formula for Bowel Preparation

Video capsule endoscopy (VCE) is a noninvasive diagnostic tool used to assess the small bowel pathology. The diagnostic value of VCE is mostly dependent on the cleanliness of the colon. Investigators are aimed to prospectively assess the quality of bowel preparation in pediatric patients receiving short peptide diet versus those receiving liquid diet.


Eligibility Criteria:
Inclusion Criteria:

* Indications of capsule endoscopy;
* Informed consent form obtained.

Exclusion Criteria:

* Contraindication of capsule endoscopy;
* Unwilling to participate;
* Formula allergy;
* Unable to swallow the capsule.
Reducing Childhood Hearing Loss in an Alaska Native Population Through a New School Screening and Referral Process That Utilizes Mobile Health and Telemedicine

Hearing loss is a common health problem in Alaska. Up to 75% of children growing up in Alaskan villages experience frequent ear infections, one of the major treatable causes of hearing loss. Children with even mild hearing loss face many challenges. These children often experience speech and language delays and have trouble in school. Teens with hearing loss are more likely to drop out of school, and are at risk for having difficulty finding jobs as adults. Promptly diagnosing and treating hearing loss is important for preventing these consequences. Alaska mandates school-based hearing screening, but many children with hearing loss are not identified by the current screening protocol, and most who are referred never make it into the healthcare system for diagnosis and treatment.

Alaska has already developed innovative strategies to address hearing loss. A network of village health clinics staffed by community health aides provide local care, and telemedicine has been adopted in over 250 village clinics statewide. Despite being widely available, telemedicine has not yet been used in school hearing screenings to speed up the referral process.

Norton Sound Health Corporation has partnered with Duke and Johns Hopkins Universities to explore whether a new school screening and referral process that incorporates mobile, or mHealth, screening and telemedicine referral will reduce childhood hearing loss disparities in the Norton Sound region. Children from kindergarten through 12th grade in 15 Norton Sound villages will receive the current school screening protocol and the new mHealth screen. Villages will then be randomized to continue the current primary care referral process or to adopt telemedicine referral for school screenings. The investigators hypothesize that the new mHealth screening protocol will identify more children with hearing loss, and telemedicine referral will reduce time to diagnosis. By better identifying hearing loss and speeding up diagnosis and treatment, the investigators expect the burden of childhood hearing loss to drop, hearing-related quality of life to improve, and school performance to improve in villages with telemedicine referral compared to current primary care referral villages. If the study shows these positive effects, mHealth screening and the telemedicine referral process could be implemented in school districts across the state of Alaska to reducing childhood hearing loss disparities statewide.


Eligibility Criteria:
Inclusion Criteria:

* Student of the Bering Strait School District (BSSD) in Alaska
* All school-aged children, from Kindergarten through 12th grade in the school district are eligible to participate
* Parental signed consent to undergo routine hearing screening in the school setting
* Verbal assent from children enrolled in the study

Exclusion Criteria:

* Not a student of the Bering Strait School District
* Parental consent for routine hearing screening not obtained
* Verbal assent not obtained