cyrilzakka/clinical-trials huggingface dataset:
Behavioral Activation and HIV Risk Reduction for Men Who Have Sex With Men With Crystal Meth Abuse

The purpose of this study is to research a new behavioral treatment to reduce sexual risk-taking in men who have sex with men (MSM) who abuse crystal methamphetamine (crystal meth), and are at risk for HIV acquisition. This study proposes using a treatment based on our original pilot study that incorporates risk reduction and behavioral activation therapy. In order to help learn what types of treatment programs best help individuals who abuse crystal meth and engage in sexual risk-taking, we will compare our treatment to a control group. The treatment group will receive therapy incorporating behavioral risk reduction counseling with behavioral activation therapy to treat depression, helping individuals reengage in their life. The control group will receive the risk reduction counseling without the behavioral activation therapy. The current study hopes to explore the efficacy of this previous developed treatment in a two-arm pilot randomized controlled trial.

1. To estimate, in a two-arm pilot randomized controlled trial (RCT), the effect size of the proposed intervention on reductions in sexual risk taking and crystal meth use. The primary outcome is the number of unprotected anal sex acts and a secondary outcome is reduction in crystal meth use episodes over the follow up period.
2. To explore the degree to which improvements in sexual risk taking are associated with the conceptual mediators of the effects of the intervention: reductions in crystal meth use and increases in pleasurable (but safe) activities, BAT skills, use of risk reduction skills, and reductions in depressed mood.

Eligibility Criteria:
Inclusion Criteria:

* Age: 18 years or older
* Self-reports as a man who has sex with men
* HIV-uninfected and verifies serostatus at baseline (HIV antibody testing and positive tests will be confirmed by Western Blots; see Human Subjects for operational aspects)
* Meets DSM-IV diagnostic criteria for crystal meth abuse/dependence
* Self reported unprotected anal intercourse-receptive or insertive-with a non-monogamous male sexual partner, while concurrently using crystal meth (use of meth must be a few hours prior to, or during, sex) in the prior three months

Exclusion Criteria:

* Unable to provide informed consent due to severe mental or physical illness, or substance intoxication at the time of interview
* Has lived in the greater Boston area for three months or less (as a means to enhance participant retention)
* Discovery of active suicidal ideation at the time of interview (these patients will be referred immediately for treatment, but may join the study when this is resolved)
Early Treatment Versus Delayed Conservative Treatment of the Patent Ductus Arteriosus

The primary goal of the trial is to compare two different Patent Ductus Arteriosus (PDA) treatment approaches: 1) an "early treatment" approach or 2) a "conservative" approach. For the purposes of the study infants will be enrolled if they are delivered before 28 weeks gestation and have a moderate/large PDA present at 5-7 days after birth.

The hypothesis is: treatment of a moderate size patent ductus arteriosus (PDA) will decrease the time needed for assisted respiratory support, diuretic therapy, and gavage feeding assistance, in addition to decreasing the incidence of ductus ligations or need for future outpatient cardiology follow-up appointments. The investigators hypothesize that one or more of these benefits will occur without an increase in the time taken to achieve full enteral feedings or in the incidence of necrotizing enterocolitis (NEC) or spontaneous intestinal perforations (SIP).The investigators will be comparing the effectiveness of early pharmacologic treatment with a control group of conservatively managed infants who will only receive treatment if they meet specific criteria for "rescue treatment".

Prior studies showed that, if a moderate/large Patent Ductus Arteriosus (PDA) is still present at 5 days after birth (among infants delivered at 23 and 0/7 to 25 and 6/7 weeks gestation) or at 7 days after birth (among infants delivered at 26 and 0/7 to 27 and 6/7 weeks gestation), it will persist for at least another 4-12 weeks if it is left untreated.

Eligibility Criteria:
Inclusion Criteria:

This will be a prospective randomized, multi-center, controlled trial that will enroll infants delivered between 23 \& 0/7 - 27 \& 6/7 weeks gestation:

1. infants must be between 5-14 days old (if delivered between 23 and 0/7 - 25 and 6/7 weeks) or 7-14 days old (if delivered between 26 \& 0/7 - 27 \& 6/7 weeks) and
2. have a "moderate size PDA" (defined as a PDA on echocardiogram that has at least one of the following criteria: internal ductus diameter ≥1.5 mm/kg (or PDA:LPA ratio ≥0.5), ductus flow velocity ≤2.5 m/s or mean pressure gradient across the ductus \<8 mm, LA/Ao ratio ≥1.5, left pulmonary artery diastolic (or mean) flow velocity \>0.2 (or \>0.42) m/sec, respectively, and/or reversed diastolic flow in the descending aorta)(13, 68, 69) and
3. are receiving respiratory support consisting of either mechanical ventilation, nasal CPAP, SiPAP, or nasal cannula flow ≥2 L/min.

   -

   Exclusion Criteria:

   prior treatment with indomethacin, ibuprofen, or acetaminophen, contraindications for the use of indomethacin, ibuprofen, or acetaminophen (these include: hydrocortisone administration within 24 hrs, urine output \< 1 ml/kg/h during the preceding 8 h, serum creatinine level \>1.6 mg/dl, platelet count \<50, 000/mm3, abnormal coagulation studies, or total bilirubin concentration (in mg/dL) \> 8 x weight (in kg)), chromosomal anomalies, congenital or acquired gastrointestinal anomalies, prior episode of necrotizing enterocolitis or intestinal perforation.

   -
Effect of Fosaprepitant on Motor Evoked and Somatosensory Evoked Potentials Under General Anesthesia

The purpose of this study is to determine if intravenous fosaprepitant can interfere with nervous system monitoring signals in patients having surgery under general anesthesia. This medication has numerous effects on the sensory nerve transmission which can theoretically have effects on the ability to accurately measure somatosensory evoked potentials.

The purpose of this study is to determine if intravenous fosaprepitant can interfere with nervous system monitoring signals in patients having surgery under general anesthesia. Fosaprepitant is a drug commonly used to prevent post-operative nausea and vomiting, and works by inhibiting "substance P", which is found in the brain and spinal cord. Theoretically, fosaprepitant could interfere with nervous system recordings because of its effect on substance P,but it is not known if this actually occurs. The drug will be given after the patient has been anesthetized but before surgical incision so that if there are any changes on the intraoperative neuromonitoring signals they can only be attributed to fosaprepitant.

If fosaprepitant alters intraoperative neuromonitoring signals during surgical procedures under general anesthesia, it would be important because anesthesiologist's who administer this drug would want to give it at the beginning of surgery when changes in intraoperative neuromonitoring signals would be unlikely to mean that these changes were due to surgical damage to the nervous system.

Eligibility Criteria:
Inclusion Criteria:

* Having a surgical procedure requiring general anesthesia, having a surgical procedure where neuromonitoing with somatosensory evoked potentials and motor evoked potentials neuromonitoring is requested by the surgical team

Exclusion Criteria:

* Patient refusal, allergy to the drug or any of its excipients, pre-operative motor or sensory deficit
Chidamide With PET Regimen for Angioimmunoblastic T Cell Lymphoma (PET: Prednisone, Etoposide and Thalidomide)

This study aims to investigate the efficacy and safety of PET regimen combined with Chidamide for angioimmunoblastic T cell lymphoma patients.

Patients enrolled in the trial would be given prednisone, etoposide, thalidomide and Chidamide, and the response and side effects are observed and documented.

Eligibility Criteria:
Inclusion Criteria:

1. Pathologically diagnosed as angioimmunoblastic T cell lymphoma (diagnosed by pathologic department in IIIA hospitals or verified by certified institutions), immunohistochemistry should include: CD3, CD4, CD8, CD20, CD10, CD21, CD35, Bcl6, CXCL13, EBER, PD-1, Ki67.
2. At least on measurable focus (≥1.0\*1.0cm by imaging), or at least one evaluable focus;
3. Age 18-75 years, both male and female;
4. ECOG 0-2, KPS≥ 70points;
5. Expected survival ≥3 months;
6. Peripheral blood neutrophil count ≥1.5×10\^9/L, platelet count≥ 75×10\^9/L, Hb≥ 90g/L;
7. Liver function: bilirubin ≤1.5 times of the normal maximum; AST、ALT≤2 times of the normal maximum (for patients with liver infiltration AST、ALT≤3 times of the normal maximum); renal function: blood creatinine ≤2 times the normal maximum;
8. Negative random pregnancy test for fertile women patients within 7 days before enrollment;
9. No radiation therapy, chemotherapy, targeted therapy nor hemopoietic stem cell transplantation within 4 weeks before enrollment;
10. No anti-tumor therapy at enrollment, including herbal therapy, immunotherapy and biologic therapy, symptomatic treatment is not within this range;

Exclusion Criteria:

1. Women during pregnancy or lactation, and fertile women that are not willing to take contraceptive measurements;
2. Patients with other malignant tumors simultaneously that have not been effectively controlled;
3. Patients with history of using HDAC inhibitors;
4. Patients who are allergic to medicine used in the trial, or have metabolic disorders toward these medicine;
5. Patients with severe active infection;
6. Patients with HIV or syphilis infection;
7. Patients with prolonged QT interval (male \> 450ms，female \> 470ms), or chronic heart failure patients with level III or IV cardiac function; or those have the following heart disease within 6 months before enrollment: acute coronary syndrome, acute heart failure (heart function level III or IV), distinctive ventricular arrhythmias (prolonged ventricular tachycardia, ventricular fibrillation, etc);
8. Patients with history of organ transplantation;
9. Patients with history of thrombosis and embolism;
10. Patients with mental disorders or those who are unable to sign a written consent;
11. Patients with drug abuse or long-time alcoholism that may influence the result of the trial;
12. Patients who do not have capacity of legal transactions;
13. Patients currently in other clinical trials;
14. Those who are recognized as inappropriate for the trial by the investigators;
Evaluation of Musculoskeletal Microcirculation With Ultrasound

This study aims to validate the use of Dynamic Contrast-Enhanced Ultrasound in measuring the blood supply to the muscles of the leg, and how this changes with exercise and vascular pathology.

We propose a model for the use of Dynamic Contrast-Enhanced Ultrasound (DCEU) to directly evaluate the microcirculation of the musculoskeletal system. We believe that this will be a valuable research tool into diseases of the microcirculation, and in the future may also offer a clinical benefit by quantifying and monitoring disease over time and after intervention. It may also allow targeting of therapies towards those patients most at risk of ulcers and peripheral neuropathy, and those that would get the maximum benefit from these therapies.

Eligibility Criteria:
Group 1 - Healthy subjects Inclusion

* 18+ years old

Exclusion

* Personal history of diabetes or peripheral arterial disease, current pregnancy, previous surgery to the lower limb, heart attack within 4 weeks, or unstable angina

Group 2 - Peripheral arterial disease subjects Inclusion

* 18+ years old, radiological evidence of peripheral arterial disease (arterial doppler or angiogram), ankle-brachial pressure index (ABPI) 0.5-0.8

Exclusion

* Personal history of diabetes, current pregnancy, previous amputation, heart attack within 4 weeks, or unstable angina

Group 3 - Diabetic subjects Inclusion

* 18+ years old, with a clinical diagnoses of diabetes (1, 2)

Exclusion

- ABPI\<0.9, previous amputation, current pregnancy or breastfeeding, heart attack within 4 weeks, or unstable angina.
A Study to Evaluate Long-Term Maintenance Treatment With Once Daily Crisaborole Ointment 2% in Pediatric and Adult Participants With Mild-to-Moderate Atopic Dermatitis

This study will evaluate crisaborole therapy once daily (QD) as a long-term topical maintenance therapy for the reduction of flare in responders to crisaborole twice daily (BID) treatment.

Approximately 700 participants will be enrolled in an run-in period to receive crisaborole, BID for up to a maximum of 8 weeks to identify crisaborole responders. A responder is defined as a participant who achieves both ISGA and EASI50 success. ISGA success is defined as achieving a score of 0 or 1 with at least 2 grade improvement from baseline; and the EASI50 success is defined as at least 50% improvement from baseline. Non responders at the end of the 8-week run-in period will be discontinued from the study.

Approximately 250 responders will be randomized (1:1 ratio) to enter the double-blind maintenance treatment period to receive crisaborole or vehicle QD for 52 weeks, with follow-up assessments every 4 weeks. If a flare occurs and if the participant meets the criteria for having a flare (ISGA ≥2), the participant will switch to enter a flare treatment period to receive open-label crisaborole BID for up to 12 weeks with follow-up assessments every 4 weeks. If the flare has resolved (ISGA ≤1) the participant will resume maintenance treatment and respective visit schedule. If a flare does not resolve after 3 consecutive treatment courses the participant will discontinue the study. A flare treatment period may comprise up to 3 consecutive treatment courses with crisaborole BID (each course is 4 weeks).

An end of study (EOS) safety follow-up is required 4 weeks after the last study treatment of any treatment period.

Eligibility Criteria:
Inclusion Criteria:

* Male or female
* 3 months of age and older
* Confirmed diagnosis of atopic dermatitis according to Hanifin and Rajka criteria
* Minimum of 5% BSA affected by atopic dermatitis
* ISGA score of Mild (2) or Moderate (3)

Exclusion Criteria:

- Has any clinically significant medical disorder, condition, or disease (including active or potentially recurrent non AD dermatological conditions and known genetic dermatological conditions that overlap with AD, such as Netherton syndrome).
Retina Projection System Trials for Low Vision People

1. Purpose

   a. Examination on Efficacy of Retina Projection System
2. Patients

   a. Low vision patients
3. Methods

   1. Vision aids

      * Retina Projection System
      * Face-mounted video display as control
   2. Comparison of Reading Speeds with both vision aids

1. Purpose

   a. Examination on efficacy of a new vision aid of Retina Projection System
2. Patients

   1. Low vision patients
   2. Vision between 0.06 and 0.3
   3. no exclusion on kinds of ocular diseases
3. Methods

   1. Vision aids

      * Retina Projection System
      * Face-mounted video display as control
   2. Computer-aided measurement of reading speeds of individual characters
   3. Comparison of reading Speeds with the two vision aids

Eligibility Criteria:
Inclusion Criteria:

* low vision patients
* vision between 0.06 and 0.3

Exclusion Criteria:

* light perception
* hand motion
* vision less than 0.06
Retrospective Study of the Uni-Graft® K DV Patch in the Clinical Routine

Uni-Graft® K DV Patch is marketed in Europe since 1999 for reconstructive interventions of the deep femoral, femoral and iliac artery and was also indicated for carotid interventions until 01/2020. Previous studies focused on the clinical performance of different patch materials used for patch angioplasty in different indications, without specifying the product or manufacturer. Thus, it is not surprising that there is a limited amount of published literature available describing the use of the Uni-Graft® K DV Patch in the clinical routine. Therefore, the aim of the present non-interventional study (NIS) is to close this gap by collecting and evaluating existing safety and performance data documented in the clinical routine especially during the application of the Uni-Graft® K DV Patch.


Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 years
* written informed consent
* treated with Uni-Graft® K DV Patch for reconstructive interventions of the carotid, deep femoral, femoral and iliac artery

Exclusion Criteria:

* Use of the Uni-Graft® K DV Patch if allergies to components of the patch are known
* Use of the Uni-Graft® K DV Patch in case of a known hypersensitive reaction to the patch and / or its components (e.g. polyethylene terephthalate).
* No use of Uni-Graft® K DV Patch
* Use of Uni-Graft® K DV Patch outside the intended use of the product at the date of application
Effect of Ultrasound Guided Embryo Transfer on Pregnancy Rates

To assess the effect of transabdominal ultrasound guided embryo transfer on the pregnancy rates versus clinical touch technique

A total of 90 patients undergoing treatment with ICSI were divided into 2 groups: group 1 (45 patients), had ultrasound guided embryo transfer and group 2 (45 patients), underwent embryo transfer using the clinical touch technique

Eligibility Criteria:
Inclusion Criteria:

* Age (20-39)
* Male factor infertility
* Ovarian factor infertility
* Unexplained infertility

Exclusion Criteria:

* Tubal factor infertility
* Endometriosis
* FSH \> 16 iu/l on cycle day 3
* Less than 2 embryos grade A
* Difficult embryo transfer
Dex on Microcirculation in SS-A Double-blinded Study

The investigators preliminary study showed that dexmedetomidine might improve microcirculation in septic shock patients. To test this effect, the investigators will conduct double-blinded study.

Dexmedetomidine is a highly selective α2-adrenoreceptor agonist for sedation of adult critically ill patients which exhibits sedative and analgesic effects. Recent studies suggest that dexmedetomidine to restore adrenergic vasoconstrictor responsiveness in septic shock, and prevents alterations of pain rat model intestinal microcirculation Induced by surgical stress，even it can reduce the mortality of endotoxemic rats and patients with severe sepsis. The investigators preliminary study showed that dexmedetomidine might improve microcirculation in septic shock patients. To test this effect, the investigators will conduct double-blinded study.

Eligibility Criteria:
Inclusion Criteria:

* Septic shock patients despite early goal directed therapy
* Agree to participate this study

Exclusion Criteria:

* Age\< 18
* Pregnancy
* Bradycardia (HR\<55bpm)
* Systolic Blood Pressure \< 80 mmHg / Mean arterial pressure \< 50 mmHg on maximal support
* Death imminent
* Unlikely to survive 90 days
* Acute liver failure
* Dementia
* High-grade block in the absence of a functioning pacemaker.
EucaLimus Post-Market Registry

To collect post marketing surveillance data on consecutive patients with coronary heart disease intended to be or treated by the Eucalimus sirolimus eluting PTCA stent when used according to the Instructions for Use. Data will be collected in order to assess the long term safety and performance of the Eucalimus PTCA stent in routine clinical practice.

The multicenter, prospective registry population consists of consecutive patients with coronary heart disease who undergo percutaneous coronary intervention (PCI) and are intended to be or treated by the Eucalimus sirolimus eluting PTCA stent (according to the Instructions for Use) as part of routine clinical care. Approximately 251 patients from 5-10 centers in Europe and Asia will be entered into the registry. Patients entered into the registry are followed for three years. The registry is considered finished when all patients have completed the 36-month follow-up.

A follow-up is scheduled at the following timepoints: immediately post-procedure, 30 days, 6 months, 12 months, 24 months, and 36 months. Follow-up is obtained by telephone contact with the patient or at a planned hospital visit.

Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients intended to be, or treated by EucaLimus as per physicians' decision and according to Instructions for Use (IFU) in the setting of routine clinical care are entered into the registry.

Exclusion Criteria:

* Patients are excluded from registration if ANY of the following conditions apply:

  * High probability of non-adherence to the follow-up requirements (due to social, psychological or medical reasons)
  * Currently participating in another investigational drug or device study in which a routine angiographic follow-up is planned
  * A life expectancy of \<1year
  * Explicit refusal of participation in the registry
Qualitative Radionuclide Shuntography for Adult Patients With Suspected V-P Shunt Malfunction

The investigators retrospectively reviewed all radionuclide shuntographic tests using (99m)technetium-pertechnetate (DTPA) performed between August 2005 and December 2015 in nuclear medicine department of Far Eastern Memorial Hospital. The results of shuntography were evaluated visually and qualitatively, and correlated with clinical follow-up. The tests were interpreted as normal and abnormal, including complete distal obstruction, partial distal obstruction or miscellaneous. Clinical outcomes within 30 days were defined based on subsequent need for revision, re-implantation or adjustment of shunt pressure. Then the investigators calculated the sensitivity (Se), specificity (Sp), positive predictive value (PPV), negative predictive value (NPV) and overall accuracy.

Introduction: Cerebrospinal fluid ventriculoperitoneal (V-P) shunts are often used in the treatment of hydrocephalus. Complications from shunts are not uncommon and can present with a variety of signs and symptoms, which could be evaluated by clinical examination and neuro-imaging. The radionuclide cerebrospinal fluid (CSF) shunt study provides a simple, effective, and low-radiation-dose method of assessing CSF shunt patency. When a discrepancy between neurological examination and imaging, additional radionuclide shuntography can be helpful. The purpose of the study was to analyze in the imaging findings and clinical interpretation of a variety of shuntography results and to determine the applicability of shuntography in patients with suspected shunt malfunction.

Materials and Methods: The investigators include all radionuclide shuntographic tests using (99m)technetium-pertechnetate (DTPA) performed between August 2005 and December 2015 in our department. No complications or discomfort were noted in the examinations. The results of shuntography were evaluated visually and qualitatively, and correlated with clinical follow-up. The tests were interpreted as normal and abnormal, including complete distal obstruction, partial distal obstruction or miscellaneous. Clinical outcomes within 30 days were defined based on subsequent need for revision, re-implantation or adjustment of shunt pressure. Then the investigators calculated the sensitivity (Se), specificity (Sp), positive predictive value (PPV), negative predictive value (NPV) and overall accuracy. The investigators would also determine the correlation with operative findings and assessment of radionuclide shuntography.

Eligibility Criteria:
Inclusion Criteria:

* all radionuclide shuntographic tests using (99m)technetium-pertechnetate (DTPA) performed between August 2005 and December 2015 in nuclear medicine department in Far Eastern Memorial Hospital

Exclusion Criteria:

* patients younger than 21 years old