cyrilzakka/clinical-trials huggingface dataset:
Specialized Treatment Early in Psychosis (STEP)

The purpose of this study is to understand the effectiveness of a specialized package of phase-specific treatments for individuals in the midst of their first episode of psychosis. The pharmacologic and psychosocial treatments will be delivered within a state public mental health center.

We propose to conduct a clinical trial for first episode psychosis patients not eligible for CMHC services that will compare randomized access to care at CMHC versus the usual procedure of referral to community providers outside CMHC. Patients randomized to access to CMHC services will receive multifaceted, intensive, phase-specific care delivered by a specialized clinical team. This care will include five principal components: antipsychotic prescription, multi-family group therapy, group cognitive behavioral therapy, cognitive remediation and individual case management including supportive, problem solving approaches and a focus on resumption of movement towards educational and/or employment related goals. All consenting subjects will undergo research evaluations every six months for up to five years. Outcomes will be assessed in the domains of re-admission (primary outcome), relapse, symptoms, overall functioning, quality of life, education and employment, treatment satisfaction, adherence, substance use, adverse events (including self-harm) and economic measures including service use, cost of care and forensic data.

Eligibility Criteria:
Inclusion Criteria:

1. Age 16-45
2. Meets DSM-IV schizophrenia spectrum psychosis or affective psychosis according to the SCID
3. ≤8 weeks of received antipsychotic treatment lifetime at time of referral
4. Willing to be treated in New Haven

Exclusion Criteria:

1. Psychosis believed due to substance use (based on the SCID)
2. Unable or unwilling to give informed consent
3. MR as indicated by receipt of services from Dept of Mental Retardation
Efficacy and Safety Study of Platelets Treated for Pathogen Inactivation and Stored for Up to Seven Days

Objective: To determine if platelets treated for pathogen inactivation and stored for 6 to 7 days are safe and effective compared to platelets collected by the same method, stored for the same amount of time and not treated for pathogen inactivation.

Although the European Commission directive 2004/33/EC states that platelet preparations may be stored for 7 days in conjunction with detection or reduction of bacterial contamination, most blood centers store platelets for only 4 or 5 days. Extending the storage time could greatly improve platelet availability for patients while decreasing wastage of this limited resource.

Eligibility Criteria:
Inclusion Criteria:

* At least 16 years old
* Written informed consent
* Thrombocytopenia, or expected to develop thrombocytopenia requiring platelet transfusion within 15 days of randomization
* Undergoing one haematopoietic stem cell transplantation and/or admitted for treatment of acute or chronic leukaemia, lymphoma, multiple myeloma or myelodysplasia

Exclusion Criteria:

* Refractoriness to platelet transfusion
* Immune-mediated thrombocytopenia, thrombotic thrombocytopenic purpura, or hemolytic uremic syndrome
* Use of IL-11 (Neumega®) or other investigational platelet growth factor
* Disseminated intravascular coagulation (DIC)
* Clinically or radiologically detectable splenomegaly
* Previous participation in the study
Effect of Higher Doses of Remifentanil on Postoperative Pain in Patients Undergoing Thyroidectomy

Extensive clinical studies have shown that intraoperative infusion high dose of remifentanil (0.2ug/kg/min) induced postoperative hyperalgesia. Recent experimental study however suggests that higher dose of remifentanil may attenuate postoperative hyperalgesia. Thus, the present study is designed as a "proof of principle" study and hypothesizes that higher dose of remifentanil may reduce postoperative pain in patients.

Remifentanil, an ultra-short acting opioid, is widely used in the patients undergoing surgery. However, extensive studies report that remifentanil,administered at 0.2ug/kg/min or 0.4ug/kg/min intraoperatively, can result in postoperative hyperalgesia and increase the consumption of analgesics when compared with low dose (0.05ug/kg/min). However, a recent experimental study shows that large dose of remifentanil can inhibit pain hypersensitivity through erasing the spinal sensitization of pain. The present study thus hypothesizes that higher dose of remifentanil (1.2ug/kg/min) may attenuate postoperative pain. The present study will compare the effect of two different dose of remifentanil (0.2ug/kg/min and 1.2ug/kg/min) on postoperative pain. Patients undergoing thyroidectomy will be recruited, and mechanical threshold will be measured in the remote region of surgical site preoperatively. The patients will be randomly divided by two groups, 0.2ug/kg/min (group I) and 1.2ug/kg/min (group II). After operation, mechanical threshold and visual analogue scale (VAS) will be measured as the indicators of postoperative pain. The consumption of morphine will also be compared between these two doses of remifentanil.

The present study may find optimized dose of opioid usage in the patients undergoing surgery to relieve the postoperative pain.

Eligibility Criteria:
Inclusion Criteria:

* ASA Grade I or II
* Age 18-60 years old
* BMI\<35,

Exclusion Criteria:

* do not consent,
* Chronic pain,
* used pain killer,
* undergoing operation previously
* diabetes or the other diseases affecting the sensory.
* difficult intubation;
* unexpected surgical complication such as bleeding;
* psychiatric disorders;
* drug or alchohol abuse
Anthropometry in Gastroesophageal Reflux Disease and Esophageal Injury

Is waist to hip ratio (WHR), waist circumference (WC), (as markers of visceral adiposity) associated with an increase in acidic and non acidic reflux as well as systemic inflammation involving esophageal mucosa, thereby increasing esophageal injury and predisposing to subsequent development of Barrett's esophagus (BE)?

The investigators will study 100 adult subjects over the age of 18 from the esophageal motility lab who are undergoing clinically indicated 24 hour acidity or basicity (pH) impedance and/or pH studies off acid suppressing medication.. These subjects will not have a prior history of esophageal surgery, or diagnosis of BE. The investigators will obtain consent for taking anthropometric measurements (Waist and hip circumference), and the results of their study. Only those subjects that successfully complete the 24 hour pH impedance studies will be included. Subjects will also undergo clinically indicated endoscopy. The investigators will consent these subjects to obtain 4 biopsies (bx) from the gastroesophageal (GE) junction and 4 bx from 5 cm above the GE junction. These bio-specimens will be stored for assessment of tissue injury (PGE2) and tissue immune-histochemistry of BE precursors (CDX1 and CDX2) at a later date.

Eligibility Criteria:
Inclusion:

* Subjects over the age of 18 undergoing clinically indicated 24 hour pH impedance and/or pH studies. Many will also undergo clinically indicated endoscopy, and consent for acquiring tissue samples for future biomarker staining tests will be obtained.
* Able to give informed consent

Exclusion:

* Subjects with a prior history of esophageal surgery, or diagnosis of BE.
Postmarketing Surveillance Study for Quadrivalent Influenza Vaccine (VaxigripTetra Inj.) in Subjects Aged 3 Years Old and Above

The objective is to describe the safety profile after 1 dose of VaxigripTetra inj. administered in subjects aged 3 years old and above under routine clinical practice.

The planned duration of each subject's participation in the study will be 21 to 28 days.


Eligibility Criteria:
Inclusion Criteria:

* Aged 3 years and above on the day of enrollment
* For subjects aged 3 to 18 years: Informed consent form has been signed and dated by the parent or other legally acceptable representative.
* For subjects 19 years and above: Informed consent form has been signed and dated by the subject.
* Receipt of one dose of VaxigripTetra inj. (on the day of inclusion) as part of routine clinical practice according to the approved local product insert

Exclusion Criteria:

- Participation at the time of study enrollment (or in the 4 weeks preceding the enrollment) or planned participation during the present study period in a clinical study investigating a vaccine, drug, medical device, or medical procedure
Exploration of Wrist Soft Tissue Injuries Associated With Wrist Fractures

The purpose of this study is to describe and stage lesions of the triangular fibrocartilage complex (TFCC) in association with distal radius fractures. 20 patients with dorsally dislocated AO type A fractures of the distal radius with sufficient displacement (based of cadaveric data) will be included. After stability testing and wrist arthroscopy. The TFCC is explored through a volar incision and injuries were documented and repaired from this approach.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-65
* Distal radius fracture
* Displacement \> 20 degrees of dorsal angulation

Exclusion Criteria:

* Previous significant wrist injury
* Declines to participate
* Ulnar styloid fracture at base or proximal to it
PK/PD Modeling of Magnesium in the Mother and Neonate

Determine significant correlations between maternal serum magnesium levels, and maternal and neonatal outcomes.

We will construct a pharmacokinetic and pharmacodynamic model of intravenous magnesium sulfate administered antenatally to expectant mothers and exposed fetuses with the aim of optimizing maternal and fetal outcomes while preventing maternal and neonatal overdosing and morbidity associated with current magnesium treatment protocols. Once we have developed a PK/PD model in our own hospital cohort, we will apply this model to a large existing NICHD database to mathematically calculate optimal dosing protocols.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women ages 18-45 years
* Magnesium sulfate exposure for preeclampsia, tocolysis, or neuroprotection
* Neonates (male or female) born at 24-42 weeks gestation
Mid-term Follow-up for Tailored ATVM

Lower urinary tract symptoms may change after pelvic organ prolapse surgery. Thus, the aim of this study was to elucidate (1) the changes of lower urinary tract symptoms and (2) the changes in values of urodynamic parameters between baseline and after pelvic organ prolapse surgery.

Between November 2011 and December 2015, medical records of all consecutive women who underwent anterior transvaginal mesh surgery (ATVM) but without concomitant mid-urethral sling surgery were reviewed. Data of pre- and post-operative lower urinary tract symptoms and urodynamic parameters were compared. The bladder outlet obstruction was defined when the detrusor pressure at maximum flow rate was not less than 40cmH2O, and the maximum flow rate was less than 12 mL/s. Overactive bladder syndrome, detrusor overactivity, bladder oversensitivity and urodynamic stress incontinence were also recognized as international continence society definition. STATA software was used for statistical analysis. Wilcoxon signed-rank test or McNemar's test was used for statistical analysis as appropriate. P \< 0.05 was considered as statistically significant.

Eligibility Criteria:
Inclusion Criteria:

* Women with pelvic organ prolapse
* Women received anterior transvaginal mesh surgery

Exclusion Criteria:

* Concomitant mid-urethral sling surgery
* Chronic urinary tract infection
* Interstitial cystitis
* Malignancy history in pelvic organ
* Ever received pelvic radiation
* Concomitant transabdominal surgery
Active Case Finding of Clinical Hand Foot Mouth Disease in Children Aged 6 Months Old to 18 Years Old in Indonesia

An observational study of active case surveillance to identify the pathogens of clinically diagnosed HFMD cases aged 6 months to 18 years old recruited from puskesmas and hospitals in Indonesia.

Every time suspected case of HFMD presented to the hospital, the pediatrician will inform the patient to enroll in the study. After the subject signs the informed consent, the pediatrician will give the subject designated number to enroll to the study. After gathering general information, medical history, and physical examination, the eligibility of participants will be assessed. The subject that fulfills the eligibility criteria will be enrolled in the study. All participants will collect stool sample or rectal swab to be tested with PCR test for EV71, CA (planned serotypes 16/10/6). If the result is positive, the sample will be further tested with genotype sequencing of EV71 and CoxA. For subject with respiratory symptom, skin lesion or encephalitis, extra PCR testing will be collected for PCR testing. Blood sample will also be collected from all subjects. Only 20 subjects with positive PCR result that will be tested for SVNT and PRNT. Two weeks following participant recruitment, study staff will contact the participant by phone and document the outcome of the disease as well the subject's condition.

Eligibility Criteria:
Inclusion Criteria:

* Clinically diagnosed HFMD children of either sex, aged 6 months - 18 years old in the study sites
* The participant's parent/ legally accepted representative (LAR) could understand and sign a documented informed consent voluntarily before the study procedures.

Exclusion Criteria:

* NA.
Comparison of Two Steroid Nasal Implants Following Endoscopic Sinus Surgery for Chronic Rhinosinusitis

The purpose of this study is to learn whether there is a difference in postoperative (after surgery) endoscopic appearance of the sinus cavities (the way that the sinuses look through a camera) between sinuses that receive one of two types of resorbable steroid eluting sinus packing (a sponge-like material which dissolves within several days while releasing a steroid): 1) Propel Implant or 2) Nasopore soaked with triamcinolone at the time of endoscopic sinus surgery (ESS) for chronic rhinosinusitis.

1. The Propel 'implant' is composed of small, flexible tubes which dissolve while releasing Mometasone which is one type of steroid. This application has been approved for use by the FDA.
2. Nasopore soaked with triamcinolone. This "packing' is a sponge-like material which dissolves while releasing triamcinolone, which is another type of steroid. Triamcinolone has been approved for use topically elsewhere on the body, although the specific use of Triamcinolone in the sinuses has not been approved by the FDA.

Both of these procedures are currently used regularly by Dr. Pearlman in practice at the conclusion of ESS for treatment of chronic rhinosinusitis. As standard of care, treatment is determined intraoperatively (during surgery), at the discretion of the surgeon. In this study, each subject will have both treatments (one in each cavity). The 'experimental' aspect relates to directly comparing the two procedures.

This research study is being done because there is currently a lack of consensus regarding the optimal nasal packing regimen. There have been no comparison studies and practice patterns vary widely. Our study looks to compare the Propel implant to Nasopore packing soaked in Triamcinolone.

Eligibility Criteria:
Inclusion Criteria:

-Adult patients undergoing endoscopic sinus surgery for the treatment of chronic rhinosinusitis refractory to medical management

Exclusion Criteria:

* Patients ineligible for informed consent
* Patients unwilling or unable to comply with the postoperative visits necessary for data collection
* Patients with a history of intolerance to triamcinolone
* Patients with suspected systemic inflammatory disease, cystic fibrosis, and any contraindication to systemic corticosteroids.
* As standard of care, the PI does not operate on pregnant patients. A pregnant patient would not be a candidate for the study.
Intraoperative Imaging of a PET Positive Lymph Node(s) Using 18FDG and a Dual-Mode, Hand-Held Intraoperative Imager

This study is a prospective collection of data utilizing the Imaging Beta Probe (IBP) in patients with positron emission tomography (PET) positive disease. A pilot clinical study involving 5 patients will be conducted using the IBP. The sterilized IBP will be used intraoperatively in surgical wounds for localization of tumor sites and detecting completeness of excision vs. positive margins. The outcome of each of these studies will be documented and used to demonstrate clinical benefits of the new probe. The investigators will correlate the images from the probe of the Fludeoxyglucose (18FDG) positive tissue, both in-vivo and ex-vivo after dissection, with the previously performed PET scan and with the routine pathology results obtained on the surgical specimens.The experimental imaging modality studied in this protocol will be compared to clinically utilized modalities of ultrasound and PET/ CT. Localization between imaging modalities will be compared with respect to: detection and side of localization.


Eligibility Criteria:
Inclusion Criteria:

* Men and women, 18- to 90-years old.
* Positive for PET positive disease in the neck.

Exclusion Criteria:

* Pregnant women (all women of child bearing potential will have undergone pregnancy testing as standard of care)
* Nursing or lactating women
Validation of an Exercise DVD for Maintenance After Pulmonary Rehabilitation.

The Public Health Agency of Canada estimates that over 3.5 million Canadians live with chronic respiratory diseases, such as COPD (chronic bronchitis and emphysema), asthma, sleep apnea, and lung cancer. Nova Scotia has been reported to have one of the highest rates of chronic lung disease among Canadian provinces, likely a reflection of both the age of the population and high rates of exposures to occupational dusts and smoking. Pulmonary rehabilitation is a multidisciplinary intervention, involving exercise and education for patients with chronic lung disease. Pulmonary rehabilitation has been demonstrated to improve patient symptoms, exercise capacity, and quality of life while reducing health resource utilization. Many studies have shown that the benefits of pulmonary rehabilitation tend to diminish over time after program completion. The best interventions to maintain the benefits of pulmonary rehabilitation remain unclear.

The purpose of this study is to validate incorporation of an exercise DVD into a maintenance program after pulmonary rehabilitation. 100 subjects will be recruited over 2-years from pulmonary rehabilitation programs at Capital Health, with 50 individuals randomized to usual care following PR and 50 individuals randomized to usual care plus the exercise DVD. Study subjects will be evaluated at time of enrolment in pulmonary rehabilitation, at completion of pulmonary rehabilitation and 6-months post- pulmonary rehabilitation. Study outcome measures will include exercise capacity, exercise compliance, health-related quality of life, confidence with performing exercise, and satisfaction with the exercise DVD. The primary outcome measure will be a change in functional exercise capacity as determined by the distance walked in 6-minutes, a commonly used and validated assessment tool for patients with chronic lung disease.


Eligibility Criteria:
Inclusion Criteria:

* any participant enrolled in pulmonary rehabilitation program

Exclusion Criteria:

* Patients who do not have access to a DVD player.
* Inability to commit to the study plan.
* Cognitive or language barriers interfering with completion of the study procedures
Ultrasound Guided Bilateral Superficial Cervical Plexus Block in Patients Undergoing Total Thyroidectomy.

The present study compared the efficacy of bilateral superficial cervical plexus block (BSCPB) versus local wound infiltration (LWI) regarding the postoperative opioid consumption in patients undergoing total thyroidectomy

We performed a double-blind, randomised, controlled trial that recruited patients undergoing total thyroidectomy at the Suez Canal University Hospital during the period between February 2019 and January 2021. Patients were eligible if they were older than 20 years, had an American Association of Anesthesiologists' (ASA) level of I-II, and were scheduled for total thyroidectomy. We excluded patients with documented allergies to the study's intervention materials, moderate-to-severe obesity, \> 1st-degree heart block, chronic pulmonary or cardiac diseases, hepatic or renal dysfunction, and/or coagulopathies. All patients were required to fill out informed consent before enrollment.

Eligible patients were randomly allocated in a 1:1 ratio to receive BSCPB or LWI using the computer software program (www. Randmizer.org) and allocation sequences were done using opaque, closed envelopes. The BSCPB group received BSCBP (after general anaesthesia but before the start of surgery) from two syringes containing ropivacaine 0.5 % and LWI with saline. The LWI group received LWI with ropivacaine 0.5% and the BSCPB from two syringes containing saline.

The primary outcome of the present study was postoperative opioid consumption in the first postoperative day. The secondary outcomes included the total intraoperative fentanyl and isoflurane consumption, time to first required analgesic, and VAS during the first 24 hours postoperatively.

Eligibility Criteria:
Inclusion Criteria:

ASA I-II, and were scheduled for total thyroidectomy

-

Exclusion Criteria:

documented allergy to study's intervention, moderate-to-severe obesity, \> 1st-degree heart block, chronic pulmonary or cardiac diseases, hepatic or renal dysfunction, and/or coagulopathies.

All patients were required to fill the informed consent before enrollment.
A Comparative Study of KW-2246

This is a placebo-controlled, double blind, comparative study to evaluate the efficacy and safety of KW-2246 as rescue medication at an optimal dose, which is determined by dose titration in treating breakthrough pain episodes in adult cancer patients receiving strong opioid analgesic on a fixed-schedule as well as rescue medication for breakthrough pain.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Have been treated with opioid analgesic on a fixed-schedule at a stable daily dose
* Receiving at least 1 but not more than 4 doses of rescue medication per day in average and whose pain is controlled
* ECOG PS =\< 3

Exclusion Criteria:

* Currently suffered from intolerable opioid-specific adverse reactions due to opioid analgesics
* Severe respiratory dysfunction
* Asthma
* Severe bradyarrhythmia
* Severe hepatic function disorder
* Severe renal function disorder
* Severe psychoneurotic disorder
* Susceptibility to respiratory depression due to such conditions as increased intracranial pressure, head injury or brain tumor