cyrilzakka/clinical-trials huggingface dataset:
An Open-Label Study of Aripiprazole Lauroxil in Subjects With Stable Schizophrenia

This study will evaluate the safety, tolerability, and pharmacokinetics (PK) of various doses and dosing intervals of aripiprazole lauroxil.


Eligibility Criteria:
Inclusion Criteria:

* Has stable schizophrenia or schizoaffective disorder
* Has demonstrated ability to tolerate aripiprazole
* Has been on a stable antipsychotic medication regimen without any changes for at least 2 months prior to screening
* Has a body mass index (BMI) of 18.0 to 35.0 kg/m2, inclusive
* Additional criteria may apply

Exclusion Criteria:

* Is pregnant, breastfeeding, or is planning to become pregnant during the study period
* Has received aripiprazole lauroxil or IM depot aripiprazole within 6 months, or other long-acting, injectable antipsychotic medication within 3 months
* Is a danger to himself/herself at screening or upon admission
* Has a history of or positive test result for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
* Has a positive urine drug screen at screening or Day 1
* Additional criteria may apply
Postoperative Pressure Injury in Patients Undergoing Prone Spinal Surgery

Patients undergoing surgery under general anesthesia are susceptible to pressure-induced soft tissue damage because there is no change in posture over an extended period of time. In particular, when the patient is in a prone position, unlike the supine position, the bony protruding portion of the front side must support the weight, which is more vulnerable to pressure injury. Previous studies have shown that the incidence of pressure injury during surgery varied from 5% to 66% and was more likely to occur in patients with long operating times, prone position, obesity, and poor skin condition. These pressure injuries increase postoperative complications, length of stay, and medical costs. Therefore, the investigators analyze the incidence of pressure injury in prone position and re-examine the risk factors of pressure injury.

All of the anesthetic and surgical procedures performed on the subject during the period from the time the subject enters the operating room to the time the subject go to the recovery room are the same as those for the existing spine surgery. Immediately after entering the operating room, immediately before going to the recovery room, and at postoperative day 1 and 2, the patient's systemic skin condition is assessed to determine whether pressure damage has occurred. The primary endpoint is the incidence of pressure injury in the subject compared with the incidence of pressure injury in previous studies. To identify the risk factors for the occurrence of pressure injury, the investigators will statistically analyze the data collected with the assumption that this is related.

Eligibility Criteria:
Inclusion Criteria:

* Adults patients undergoing elective spine surgery in prone position under general anesthesia

Exclusion Criteria:

* Pre-existence of pressure injury
High MAP in Septic Shock With Hypertension

We hypothesized that the increase in MAP from 65 mmHg to patients' usual level improved sublingual microcirculation.

The effect of mean arterial pressure (MAP) titration to higher level on microcirculation in septic shock patients with previous hypertension remains unknown. Our goal was to assess the effect of MAP titration to patients' usual level on microcirculation in septic shock patients with previous hypertension. We hypothesized that the increase in MAP from 65 mmHg to patients' usual level improved sublingual microcirculation.

Eligibility Criteria:
Inclusion Criteria:

* Patients with septic shock for less than 24 hours
* Fluid resuscitation was performed according to the guideline for treating septic shock to maintain the central venous pressure (CVP) for more than 8 mm Hg and central venous oxygen saturation for more than 70%
* Patients requiring norepinephrine (NE) to maintain a MAP of 65 mm Hg. Septic shock patients with fluid resuscitation after CVP \> 8mmHg and mean blood pressure \> 65 mmHg

Exclusion Criteria:

* Pregnancy
* Age \< 18 years
* Inability to acquire the usual level of MAP
* Refusal of consent by the patient or relative
* Participation in other trials during the last three months
* Hypertensive patients without hypertension treatment
The Effect of Oxygen Therapy on Atelectasis

In pregnancy, cephalal shift of the diaphragm caused by the enlarged uterus reduces the functional residual capacity and may increase the closure volume and predispose the pregnant woman to airway closure, leading to atelectasis. The development of atelectasis due to dermatomes retained in spinal anesthesia and intraoperative supine position may increase further. Oxygen therapy to be applied may also lead to absorption atelectasis by causing hyperoxia. The aim of our study is to evaluate the effect of oxygen support on the lungs in cesarean section operations under spinal anesthesia by lung ultrasound score and oxygen reserve index.


Eligibility Criteria:
Inclusion Criteria:

* 18-50 years old
* ASA I-II
* Patients scheduled for elective cesarean section under spinal anesthesia

Exclusion Criteria:

* alcohol or drug addiction, chronic obstructive pulmonary disease, cardiovascular disease, smokers anemia, liver or kidney disease, coagulation disorders allergic to anesthetic agents, sepsis or bacterial infection, body temperature is below 35°C and above 38°C Multiple pregnancy Preoperative hypoxemia SpO2\<94% Diabetes mellitus Hypertension Placenta previa Premature rupture of membranes Intrauterine growth retardation Preeclampsia-eclampsia-fetal distress Polyhydramnios Morbid obesity BMI\>45
"Reading Subtitles Skills in the Elementary School"

Theme: The reading of fixed texts in school are widely known, however it is not known how they read texts furniture and what skills are required for this type of reading.

Objective: To evaluate the skills of reading film subtitles in students of 2nd and 4th grade of elementary school of a Public School.

Method: Review the level and skills of reading movies subtitles (RMS), through the recounting of a section of film watched, alone, mute and legend, for 60 students (30 2nd grade and 30 of the 4th grade) matched for age and gender.

The purpose of this study was to compare the reading film subtitles skills in students aged 2nd and 4th grade of elementary school (EF) from a public school, and relate the performance of literacy in school with reading film subtitles.

Proceedings: The study included 30 students from 2nd and 30 from 4th grade of a public school at Sao Paulo. The participants' ages ranged from 7 years and 8 months to 9 years and 3 months in the 2nd grade, and 9 years and 9 months to 11 years and one month in the 4th grade. The groups were matched for the genre.

Inclusion criteria: sign a consent to search, be literate, do not have any sensory changes, and never repeated a grade. Each subject, individually, was rated about the level of literacy and reading through the protocol of school literacy; and about reading film subtitles skills.Each subject recounted what he understood and responded to five inferential questions about the movie.The recount was analyzed and scored on a specific protocol based on Castillo (1999).Students could score in four levels: decoding, literal comprehension, comprehension independent and critical reading.

Eligibility Criteria:
Inclusion Criteria:

* sign a consent to search
* be literate
* do not have any sensory changes
* and never repeated a grade
Evaluation of an Karajishi Contour Investigational Blood Glucose Monitoring System

The purpose of this study is to determine if subjects who have diabetes can operate the Investigational Blood Glucose Monitoring System (BGMS) without training and obtain valid glucose results.


Eligibility Criteria:
Inclusion Criteria:

* Males and females, 18 years of age and older
* People with type 1 or type 2 diabetes
* Able to speak, read, and understand English
* Willing to complete all study procedures

Exclusion Criteria:

* Hemophilia or any other bleeding disorder
* Pregnancy
* Physical, visual, or neurological impairments that would make the person unable to perform testing with the BGM
* Previously participated in a BG monitor study using the Karajishi BGMS (or used a Bayer Contour meter)
* Working for a medical laboratory, hospital, or other clinical setting that involves training on and clinical use of blood glucose monitors
* Working for a competitive medical device company, or having an immediate family member who works for such a company
* A condition which, in the opinion of the investigator or designee, would put the person or study conduct at risk
A Phase 2 Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of VX-135 and Daclatasvir in Subjects With Genotype 1 Chronic Hepatitis C Chronic Hepatitis C

A Phase 2 Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of VX-135 and Daclatasvir in Treatment-Naïve Adult Subjects With Genotype 1 Chronic Hepatitis C


Eligibility Criteria:
Inclusion Criteria:

* Subjects must have genotype 1 CHC and evidence of HCV infection at least 6 months before screening
* Subjects must be treatment-naïve and have not received prior treatment with any interferon, immunomodulatory agent, or DAA for HCV

Exclusion Criteria:

* Evidence of cirrhosis
* History or other clinical evidence of significant or unstable cardiac disease
* Any other cause of significant liver disease in addition to hepatitis C
* Creatinine clearance ≤50 mL/min using the Cockcroft-Gault equation at screening
* Female subjects who are pregnant or nursing
Open Pilot Trial of Adapted Cognitive Processing Therapy for Comorbid PTSD and Opioid Use Disorder

The goal of this open pilot trial is to learn if an adapted version of Cognitive Processing Therapy (CPT), delivered through telehealth, can treat posttraumatic stress disorder (PTSD) in adults who use syringe services programs. The main questions it aims to answer are:

* Can the intervention be done in syringe services programs?
* Are syringe services program clients and staff open to the intervention?
* Can the intervention lower PTSD symptoms and help participants keep taking their medication for opioid use disorder (ex. Buprenorphine or methadone)?

Participants will:

* Attend 4-18 tele-delivered CPT sessions at the syringe services program
* Complete between-session CPT practice with the support of SSP-based "coaches"
* Meet with research staff monthly to complete surveys of their PTSD symptoms, drug use, and mental health


Eligibility Criteria:
Inclusion Criteria:

* Over the age of 18
* Regular syringe services program attendance (ex. at least 4 visits in the past month)
* Meeting DSM-5 opioid use disorder criteria
* Having been prescribed a medication for opioid use disorder in the past 30 days at the time of screening
* Criterion A event as measured by the Life Events Checklist for DSM-5 (LEC-5)
* PTSD symptoms at the level of a PTSD diagnosis as evidenced by a score of 31 or greater on the PTSD Checklist for DSM-5 (PCL-5)
* Ability to understand English
* Consent to have assessment interviews audio recorded and teletherapy sessions video recorded for research purposes
* Ability to provide informed consent

Exclusion Criteria:

* High risk for suicidal thoughts and/or behaviors that would make participation dangerous, as measured by the Columbia Suicide Severity Rating Scale Lifetime-Recent Screen
* Meeting DSM-5 criteria for a current psychotic or bipolar disorder.
* Cognitive impairment liable to interfere with completion of study procedures
* Currently receiving trauma-focused psychotherapy (i.e. Prolonged Exposure, Cognitive Processing Therapy).
Study of Association of Anti-inflammatory and Anti-rheumatic

Phase III Study, double-blind, comparing association of anti-inflammatory and anti-rheumatic in 375 subjects with knee osteoarthritis.

Evaluation after 12 weeks of treatment, in 3 arms, the efficacy and safety of the association.

Eligibility Criteria:
Inclusion Criteria:

* Signs the Informed Consent Form
* Age between 40 and 85 years
* osteoarthritis of the knee according to clinical and radiological criteria of the American College of Rheumatology

Exclusion Criteria:

* Cardiovascular disease
* Serious chronic comorbidity
* Hypersensitivity to any component of the study drugs
* body mass index\> 30 kg / m²
A Randomized, Double-Blind, Placebo-Controlled, Single-Dose Escalation Phase I Clinical Study to Assess the Safety, Pharmacokinetics, and Immunogenicity of HLX6018 in Healthy Subjects

The purpose of this study is to investigate the safety, PK, and immunogenicity of a single intravenous administration of HLX6018 in healthy subjects, based on the preliminary efficacy and safety established through in vitro and in vivo experiments.

This is a randomized, double-blind, placebo-controlled study with single dose escalation design to assess the safety, PK, and immunogenicity of HLX6018 in healthy subjects. It is planned to enroll 8-10 subjects in each of seven dose groups (0.25 mg/kg, 1.0 mg/kg, 4.0 mg/kg, 12 mg/kg, 25 mg/kg, 50 mg/kg, and 70 mg/kg). This is the first-in-human study of the investigational product.


Eligibility Criteria:
Inclusion Criteria:

1. Fully informed about the nature, significance, potential inconveniences, and associated risks of the study prior to enrollment. Comprehend the study's procedures and methodology, agree to follow the clinical study protocol, and give voluntary written informed consent;
2. 18-55 years old, including the boundary value, male or female;
3. Body weight: 45-85 kg for females and 50-85 kg for males, including the boundary value; body mass index (BMI): 18.0-28.0 kg/m2 , including the boundary value, (BMI = body weight (kg)/body height2 (m2));
4. Subjects, including males, must have no childbearing plan and take effective contraceptive measures from the time of informed consent to 6 months after the administration of the study drug.
5. Physical examinations and vital signs should be normal or abnormal without clinical significance.

Exclusion Criteria:

1. Any clinically significant laboratory test abnormalities or, within 12 months before screening, any other clinically significant clinical findings indicative of diseases, including but not limited to gastrointestinal, renal, hepatic, neurological, hematological, endocrine, oncological, pulmonary, immunological, psychiatric, or cardiovascular conditions;
2. Donation/loss of ≥ 450 mL of blood or receipt of blood transfusion or use of blood products within 3 months prior to screening, or planning to donate blood during the study or within 1 month after the end of the study;
3. Patients with severe trauma or major surgery within 3 months before screening, or planning to undergo surgery during the study;
4. Patients who smoke more than 5 cigarettes per day in the 3 months before screening;
5. History of drug abuse or addiction or alcohol abuse (14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine);
Systemic Versus Local Dexmedetomidine As an Adjuvant to Bupivacaine in Ultrasound Guided Erector Spinae Block

The aim of this study is to investigate the analgesic effect of local versus systemic dexamedetomedine as adjuvant to bupivacaine in erector spinae block in kidney exploration surgeries.

Open Kidney surgeries remain one of the approaches used for those patients are requiring partial or radical nephrectomy and is associated with a high incidence of intense immediate postoperative pain and chronic pain for months following surgery.

Effective treatment of postoperative pain allows early mobilization of the patient, shortens the recovery and discharge time, prevents the development of chronic pain, and increases satisfaction and long-term quality of life.

Current modalities used to manage pain for patients undergoing kidney exploration include oral and parenteral opioid administration, local anesthetic infiltration, and certain neuraxial and regional anesthesia procedures including thoracic epidurals and paravertebral blocks.

The erector spinae plane (ESP) block is a newer regional anesthetic technique that can be used to provide analgesia for a variety of surgical procedures or to manage acute or chronic pain. The technique is relatively easy to perform on patients, and it is performable with minimal or no sedation in the pre-operative holding area.

Ultrasound is a non-invasive visualization technology that helps capture the anatomical structure of target tissues; it can help guide the direction and depth of anesthesia puncture needles, thus reducing the risk of complications.

The local anesthetic drugs have a limited duration of action, so we need to add adjuvants such as opioids, alpha two agonists, neostigmine, or magnesium.

Dexmedetomidine is a potent α2 agonist and is a powerful adjuvant to regional anesthesia and analgesia. It can prolong the duration of the nerve block anesthesia resulting in increased effectiveness of the block in terms of duration, less use of opioids, and shorter hospital stay in the absence of clinically significant side effects (hypotension, nausea, vomiting, and pruritus.

Adding adjuvants to local anesthetics is frequently used to prolong the duration of single-injection regional nerve block.

There have been multiple studies claiming increased effectiveness of use of dexmedetomidine and this has been consolidated in a meta-analysis examining the effectiveness of dexamedetomedine as a peripheral nerve block adjuvant.

Eligibility Criteria:
Inclusion Criteria:

•. kidney exploration surgeries.

* ASA I/II patients.
* BMI \<35

Exclusion Criteria:

* Getting opioid analgesics prior to surgery.
* Local infections at the site where needle for block is to be inserted.
* ASAIII/IV.
* Pregnancy.
* History of drug addiction or alcohol abuse or a psychiatric illness,
Study of Lung Function in Children Who Have Undergone Bone Marrow Transplantation

RATIONALE: Assessing the long-term effects of bone marrow transplant on lung function in patients may improve the ability to plan treatment.

PURPOSE: This clinical trial studies lung function in pediatric patients who have undergone bone marrow transplant.

OBJECTIVES:

* Determine the delayed effects of bone marrow transplantation preparative regimens on pulmonary function in children surviving at least 5 years after transplantation for hematologic malignancy.
* Determine the relationship between pulmonary function and growth rates in these patients.
* Determine the effect of growth hormone treatment on pulmonary function in these patients.
* Determine the relationship between pulmonary function and age at time of transplantation in these patients.
* Determine the incidence and severity of restrictive pulmonary disease, and whether these factors vary with increasing time after transplantation in these patients.

OUTLINE: Patients undergo respiratory history, signs and symptoms assessment, pulmonary function tests (PFT) including spirometry, lung volumes, and diffusion, oxygen saturation by pulse oximetry, and height measurement.

Patients are assessed at 5-10 years, 10-15 years, and over 15 years after bone marrow transplantation. Patients with abnormal PFTs are assessed at more frequent intervals as clinically indicated.

PROJECTED ACCRUAL: Approximately 280 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Patients who have undergone bone marrow transplantation for hematologic malignancy at least 5 years ago

  * Disease-free survivors at least 6 years of age AND
  * Under 18 years of age at time of transplantation
* Received prior allogeneic, unrelated donor, syngeneic, or autologous bone marrow transplantation
* Able to perform pulmonary function tests

PATIENT CHARACTERISTICS:

Age:

* See Disease Characteristics

Performance status:

* Not specified

Life expectancy:

* Not specified

Hematopoietic:

* Not specified

Hepatic:

* Not specified

Renal:

* Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* See Disease Characteristics

Chemotherapy:

* Not specified

Endocrine therapy:

* Not specified

Radiotherapy:

* Not specified

Surgery:

* Not specified

Other:

* Any prior preparative regimen allowed
Trial of Modifications to Radical Prostatectomy

This trial will evaluate whether the following aspect of surgical technique influence outcome: Lymph node dissection. In some patients, scans taken before surgery show that a lymph node has cancer. Surgeons make sure to remove those affect lymph nodes and all other lymph nodes in the area. However, it is not known whether removing lymph nodes helps prostate cancer patients whose scans do not show positive nodes. In this study, patients with clear scans will either receive a lymph node dissection or not."


Eligibility Criteria:
Inclusion Criteria:

* Patients do not have to be eligible for both modifications to be included in the study.

Lymphadenectomy vs no lymphadenectomy:

* Patients 21 years or older scheduled for radical prostatectomy for treatment of prostate cancer with one of the consenting surgeons at MSKCC

Hemostatic agent vs. no hemostatic agent

* Patients 21 years or older scheduled for minimally invasive radical prostatectomy for the treatment of prostate cancer with one of the consenting surgeons at MSKC

Exclusion Criteria:

Lymphadenectomy vs no lymphadenectomy

* Presence of positive/suspicious pelvic nodes on MRI, CT or PSMA scan (positive/suspicious defined as a pelvic node \>15mm in short axis on CT or MRI, a PSMA avid node, or a node with abnormal morphology such as roundness or irregularity or loss of fatty hilum)
* Any prior pelvic radiation therapy used to treat prostate cancer

Hemostatic agent vs. no hemostatic agent

* No additional exclusion criteria
Perioperative Administration of Pregabalin for Pain After Mastectomy

The investigators hypothesize that pregabalin will decrease post-operative pain scores and analgesic use following total mastectomy compared to placebo. The primary outcome will be acute postoperative pain, measured by a verbal numerical rating score (VNRS) and total analgesic consumption during postoperative 48 hours. The secondary outcome will be VNRS at 1 week and 1 month after operation.


Eligibility Criteria:
Inclusion Criteria:

1. American Society of Anesthesia physical status class I \& II
2. Age \> 20 and \< 70 years
3. Robot- assisted endoscopic thyroidectomy

Exclusion Criteria:

1. Known or suspected allergy, sensitivity, or contraindication to pregabalin or any of the standardized medications
2. Body mass index ≥ 40 kg/m2
3. History of seizure disorder
4. Current therapy with pregabalin, gabapentin, or any opioid
5. Any other physical or psychiatric condition which may impair their ability to cooperate with post-operative study data collection
6. Insulin-dependent diabetes mellitus
7. Renal insufficiency (estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73 m2)