cyrilzakka/clinical-trials huggingface dataset:
Aripiprazole Augmentation for Clozapine-Treated Patients With Refractory Schizophrenia

The purpose of this study is to determine whether aripiprazole augmentation is safe and effective in the treatment of clozapine-treated patients with refractory schizophrenia.

Clozapine is renowned for its efficacy in treating schizophrenia refractory to typical or atypical antipsychotics. Though the effectiveness of clozapine has been established, a considerable number of patients with schizophrenia are partially responsive or unresponsive to clozapine. In addition, long-term use of clozapine is associated with the development of obsessive-compulsive symptoms and metabolic syndrome. In order to overcome these short-comings and to increase efficacy, aripiprazole augmentation was implemented. Quantitative electroencephalogram will be used to monitor the occurrence of abnormal findings and to analyze the changes in electroencephalographic pattern with linear and non-linear methodology.

Comparisons: Design of double-blind randomized placebo controlled study of patients at Refractory Schizophrenia Clinique in Department of Neuropsychiatry at Seoul National University Hospital.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients, 18-65 years of age.
* Patients must have a diagnosis of schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV).
* Female patients of menarche must be using a medically accepted means of contraception (e.g. oral contraceptives, Depo-Provera, abstinence).
* Each patient must provide written informed consent after full explanation of study protocol, and authorized legal guardian must understand the nature of the study and must also give assent to study participation.
* Patients must have a baseline (day 0) BPRS score of at least 35 or over 2 of 5 SANS global rating item scores of at least 3.
* Patients have been receiving clozapine treatment for more than 1 year and there has been no change in clozapine dosage for more than 3 months.
* Patients must have a history of antipsychotic treatment with at least 2 different kinds prior to clozapine administration.
* Subjects who are fluent in Korean.

Exclusion Criteria:

* DSM-IV substance (except nicotine or caffeine) dependence within the past 1 year.
* Female patients who are either pregnant or lactating.
* Mental retardation (IQ \< 70).
* Neurological disorders including epilepsy, stroke, or severe head trauma.
* Clinically significant laboratory abnormalities, on any of the following tests: CBC with differential, electrolytes, BUN, creatinine, hepatic transaminases, urinalysis and EKG.
* Prior history of aripiprazole non-response or intolerance.
* BPRS score of \< 35 and over 4 of 5 SANS global rating item scores of \< 3.
* Participation in a clinical trial of another investigational drug within 3 months (90 days) prior to study entry.
* Treatment with an injectable depot neuroleptic within less than three dosing interval between the last depot neuroleptic injections and baseline (day 0).
* History of electroconvulsive therapy within the past 3 months.
* Subjects who are not fluent in Korean.
Phase 1, Open-label, Dose Escalation Study of TRC093, in Patients With Locally Advanced or Metastatic Solid Tumors

This study is being performed to evaluate the safety and tolerability of the TRC093 antibody.

In addition to safety, this study will also evaluate pharmacokinetics, tumor response, and anti-TRC093 antibody formation.

Eligibility Criteria:
Inclusion Criteria:

A patient will be eligible for study participation only if all of the following criteria apply:

1. The patient has given informed consent.
2. The patient is willing and able to abide by the protocol.
3. The patient is at least 18 years old.
4. The patient has advanced cancer and is not eligible for treatment or no effective treatment exists.
5. Significant toxicities resulting from prior therapy must have recovered.
6. If the patient is a female of childbearing potential, she is using an acceptable/effective method of contraception.
7. If the patient is a female, she has had a negative serum pregnancy test within the past 30 days.
8. The patient has adequate ability to perform activities of daily living.
9. The patient has adequate organ function as assessed by laboratory tests

Exclusion Criteria:

A patient will not be eligible for study participation if any of the following criteria apply:

1. The patient weighs more than 264 lbs.
2. The patient has had a major surgical procedure, or significant injury within the past 28 days or there is an anticipation of the need for major surgery during the course of the study.
3. The patient has received treatment for their cancer, including radiation (minimal amount of localized radiation may be allowed), within the past 28 days.
4. The patient has known brain tumors.
5. The patient experienced blood clots within six months prior to study start.
6. The patient has a non-healing wound, ulcer or bone fracture.
7. The patient received recent thrombolytic or anticoagulant therapy.
8. The patient has an unstable medical condition or significant comorbid pathophysiology (e.g. active infection, poorly controlled diabetes, unstable angina, severe heart failure) that would interfere with his/her participation in the study.
9. The patient enrolled, or plans to enroll, in a concurrent treatment protocol with another investigational product.
10. The patient is receiving, or plans to receive, an anti-cancer therapy during the study with the exception of patients receiving chronic luteinizing hormone-releasing hormone (LHRH) agonists.
Gathering Online for Dialogue and Discussion to Enhance Social Support

The goal of this trial is to test a modified mobile health intervention (with a group component) relative to a mobile health intervention in a two-arm randomized trial with 500 young African American women who are human immunodeficiency virus (HIV)-negative and who misuse alcohol.

The expected outcomes are to: (1) determine the efficacy of the virtual group component in reducing alcohol use and sexual risk and increasing pre-exposure prophylaxis (PrEP) utilization; and (2) understand selected outcomes for implementation.

Participants will be randomized to receive either the mHealth app or the mHealth app plus the group component, and followed up at 3-, 6-, 9-, and 12-months post-enrollment.

A total of 500 participants who are human immunodeficiency virus (HIV)-negative who engage in heavy alcohol use will be enrolled and referred to their local health departments for pre-exposure prophylaxis (PrEP). Primary biobehavioral outcomes assessed will include reduced alcohol use (self-reported and biological, including phosphatidylethanol \[PEth\]), increased PrEP uptake (self-reported and biological), and reduced sexual risk (self-reported condomless sex and impaired sex and biological testing for HIV/sexually transmitted infections \[STIs\]) at 3-, 6-, 9-, and 12-month follow-up.

Eligibility Criteria:
Selected Inclusion Criteria:

* identify as Black/African American
* identify as female
* be between 18 and 30 years old
* recent substance use
* HIV negative and not currently on PrEP
* have an Android or iOS-based smartphone

Selected Exclusion Criteria:

* test positive for HIV
* participated in the previous study activities of the current study or previous related studies
The Impact on Recurrence Risk of Adjuvant Lenvatinib for Patients With Hepatocellular Carcinoma And Microvascular Invasion (MVI) After Hepatectomy : A Random, Controlled, Stage III Clinical Trial.

To compare The Impact on Recurrence Risk of Adjuvant Lenvatinib for Patients With Hepatocellular Carcinoma And Microvascular Invasion (MVI) After Hepatectomy.


Eligibility Criteria:
No

Criteria:

Inclusion Criteria:

older than 18 years old and younger than 75 years; ECOG PS\<3; proven hepatocellular carcinoma with MVI according pathological examination; not previous treated for tumor; tumor was removed in operation; no recurrence occurence at 4 to 7 weeks after surgery; the lab test could meet: neutrophil count≥1.5×109/L; hemoglobin≥80g/L; platelet count≥60×109/L; serum albumin≥28g/L; total bilirubin\<3-times upper limit of normal; ALT\<5-times upper limit of normal; AST\<5-times upper limit of normal; serum creatine\<1.5-times upper limit of normal; PT≤upper limit of normal plus 6 seconds; INR≤2.3; sign up consent; unrolled by other clinical trials about hepatocellular carcinoma.

Exclusion Criteria:

cannot tolerate lenvatinib; CNS or bone metastasis exits; known history of other malignancy; be allergic to related drugs; underwent organ transplantation before; be treated before (interferon included); known history of HIV infection; known history of drug or alcohol abuse; have GI hemorreage or cardiac/brain vascular events within 30 days; pregnancy;
Impact of a Strategy Based on Bacterial DNA Detection to Optimize Antibiotics in Immunocompromised Patients With Hospital-acquired Pneumonia Requiring Mechanical Ventilation

RESPIRE is a randomized, unblinded, controlled study to measure the impact of a strategy based on a PCR test on the adjustment of antimicrobial therapy in immunocompromised patients suspected with ventilator-associated or hospital-acquired pneumonia (VAP/HAP) requiring mechanical ventilation (MV) in Intensive Care Unit (ICU). The gold-standard microbiological diagnostic method for pneumonia in the ICU is based on culture identification and antimicrobial susceptibility testing. Results are obtained in several days after the initiation of empiric antimicrobial therapy, exposing patients to a potential inappropriate broad-spectrum antimicrobial treatment. We aim to measure the impact of a PCR-based strategy to improve the percentage of patients with VAP or HAP receiving targeted antimicrobial therapy 24 hours after diagnosis compared to standard care


Eligibility Criteria:
Inclusion Criteria:

* Adult immunocompromised patients hospitalized in ICU with suspected VAP or HAP requiring MV

Exclusion Criteria:

* No immunodeficiency Moribund patients (SAPS II \> 90) Pregnant women Refuse to participate to the study
Detailed Phenotypic and Genotype Study to Correlate RB1 Mutations Relating to Primary Ocular Tumors and Secondary Extra-ocular Metastasis.

The goal of this observational study is undertake a detailed phenotypic and genotypic study of patients with ocular and secondary cancers due to mutations in the RB1 gene. Our research sequencing approach will allow advanced insight to for further detailed genotypic understanding of parent-of-origin for valuable insight into the genotype-phenotype relationship of this cancer syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Patients with molecularly proven retinoblastoma due to RB1 or a typical clinical retinoblastoma phenotype with genetic screening pending.
* Able to give consent/parent or guardian able to give consent.

Exclusion Criteria:

* Patients unable or unwilling to undertake consent or clinical testing.
* Patients unwilling to donate a saliva or blood sample in order to establish the genetic cause of their condition.
Nutritional Supplements and Foot Surgery

This is a prospective randomized trial wherein participants will be assigned to NutraHeal™, NutraHeal Plus™, or standard of care for 1 week prior to foot surgery and 3 weeks after surgery. The central hypothesis is that among patients undergoing surgery, nutritional supplements that maintain energy production, muscle structure, immune function, and response to pain will support recovery from surgery.

Over a 6 month period the investigators will enroll 45 male and female patients undergoing foot surgery. This is a prospective randomized trial and participants will be assigned to NutraHeal™ (n=15), NutraHeal Plus™ (n=15), or standard of care (n=15) for 1 week prior to surgery and 3 weeks after surgery. NutraHeal™ is a nutritional supplement that contains 7.5 micrograms (300 IU) of Vitamin D3, 80 mg of Calcium as Calcium Hydroxymethylbutyrate Monohydrate, 7.5 mg of Zinc, 600 mg of Calcium Hydroxymethylbutyrate Monohydrate, and 45 mg of Bromelain. NutraHeal Plus™ is a nutritional supplement that contains 80 mg of Calcium as Calcium Hydroxymethylbutyrate Monohydrate, 7.5 mg of Zinc, 600 mg of Calcium Hydroxymethylbutyrate Monohydrate, 45 mg of Bromelain, and 7.5 mg of reduced Nicotinamide Adenine Dinucleotide (NADH). Patients randomized to standard of care will not receive any of the ingredients in NutraHeal™ or NutraHeal Plus™.

The foot surgeon will evaluate the patient for wound healing time, healing quality, erythema and new tissue quality, using a Likert rating scale against expected results from -4 (much worse) to +4 (much better) including the expected reference grade of zero (0). Wound healing will be assessed at 1 and 3 weeks after surgery. Patients will document medication compliance (day of surgery, 1 and 3 weeks after surgery), pain medication use (baseline, on the day of surgery and at 1 and 3 weeks after surgery) and rate overall satisfaction (5-point scale (1 = excellent; 2 = good; 3 = moderate; 4 = sufficient; 5 = unsatisfactory) at 3 weeks after surgery). Patients will also complete the PROMIS-29 instrument at baseline, the day of surgery, and at 1 and 3 weeks after surgery).

Eligibility Criteria:
Inclusion Criteria:

* ≥ 20 years of age
* Undergoing foot surgery (matrixectomy (ingrown toenail removal) and wart removal)

Exclusion Criteria:

* \> 80 years of age
* Pregnant patients or those anticipating pregnancy in the 1 month study period
* Allergic to pineapple
* Treated with oral anticoagulation
* Currently receiving Bromelain, Hydroxymethylbutyrate Monohydrate (HMB), reduced Nicotinamide Adenine Dinucleotide (NADH), Vitamin D3, or Zinc.
* Alcoholism (\>2 drinks/day)
* Insulin Dependent Diabetes
* Hepatic insufficiency (prior known liver function tests \> 1.5 times the upper limit of normal)
* Renal failure (prior known creatinine \> 2.0 mg/dl)
* Severe pulmonary disease (requiring home oxygen therapy)
* Psychiatric illness requiring therapy (DSM-V thought disorders, recurrent major depressive disorder)
A Pilot Analysis of the Association Between Anesthesia Induction Dosing and AKI in the Elderly Population

This study proposes to perform a pilot observational study looking at the doses of propofol used for the induction of general anesthesia and its association with the development of hypotension and AKI among elderly patients at YNHH.

The first stage of this study proposes to perform a pilot observational study looking at the doses of propofol used for the induction of general anesthesia. We will determine the percent (as a function of age, Elixhauser score, ASA status) of patients who receive more than the FDA approved induction dosage. We estimate 30% with the power defined as the width of the 95 percent confidence interval around that number that is given by 80% power and n=500.

In the second stage, the investigators will look at the association between dose and the development of hypotension (in the time after induction and before surgical incision) and post-operative AKI among elderly patients at YNHH while controlling for age, Elixhauser score, and ASA status. The results of this study will also hopefully be used in a quality improvement project to prevent overdosing of the elderly patient population with induction anesthetic.

Hypothesis 1: Elderly patients are being overdosed (per FDA guidelines) with anesthetic agents for induction of general anesthesia.

Hypothesis 2: Overdose of anesthetic agents for induction of general anesthesia in the elderly population leads to an increased chance of developing AKI.

Hypothesis 3: Overdose of anesthetic agents for induction of general anesthesia in the elderly population leads to an increased chance of developing hypotension post-induction, which may contribute to development of AKI or vice-versa.

This research will be done via analysis of data and associated records contained in the Multicenter Perioperative Outcomes Group databases at Yale (the latter is a research database approved under HIC#1206010438).

The possible risks are primarily the risk to privacy that is inherent in any retrospective chart review. The benefit may be to suggest areas for quality improvement in induction practices for elderly patients at YNHH and elsewhere.

Eligibility Criteria:
Inclusion Criteria:

* Patients age 65 or older who underwent induction of general anesthesia at YNHH
* Only first surgery for each patient within the time period is counted
* Only include patients who underwent intubation
* Only include patients who underwent induction by propofol bolus
* Only include patients who got at least 0.3mg/kg of propofol

Exclusion Criteria:

* Patients under the age of 65, patients who underwent monitored anesthetic care/conscious mediation for their procedures.
* Patients with renal failure and/or chronic kidney disease
* Patients who have a pre-operative systolic blood pressure \<100
Hip Strengthening and Manual Therapy for Heel Pain Patients

The purpose of this study is to compare the effects of manual therapy and of manual therapy associated with hip strengthening in the recovery of patients with heel pain.

Heel pain decreases function, balance, walking and can cause change in the movement pattern. This alterations can induce a deficit in motor control of other structures as knee and hip. There is an importance to compare the effects of manual therapy and manual therapy associated with hip strengthening on the recover of patients with heel pain.

After the initial assessment and data collection, participants will be randomly assigned to one of two intervention groups. Randomization will be held electronically in http://graphpad.com/quickcalcs/index.cfm site by simple random sampling. Patients will be treated for a maximum of 10 sessions, each session lasting about 40 minutes and each week two sessions. The maximum duration of treatment is 3 months. A physical therapist will be responsible for the screening of eligible patients and the random allocation of participants A second professional will be responsible for physical therapy initial and final evaluation and will be blind to the interventions. A third physical therapist will perform the interventions. The physiotherapist in charge of intervention will be blind to the initial and final evaluation.

Eligibility Criteria:
Inclusion Criteria:

* Patients with heel pain, that increases on the first steps after a period without activity and with long periods on standing position, regardless of age and gender and that didn't went under any physiotherapeutic treatment in the last 3 months.

Exclusion Criteria:

* Patients who have a history of surgery on the lower limb on the past 6 months; patients with bilateral heel pain; patients under psychiatric treatment; patients that went under a manual therapy scheme treatment for heel pain before; rheumatic syndromes; patients who receive some benefit labor or patients underage.
Qualitative Exploratory Study Among Reunionese Women and Their Partners Who Have a Child With Trisomy 21

According to data from French congenital malformation registries, the prevalence of Down Syndrome (DS) in 2017 (live births and medical termination of pregnancy (MToP)) in Reunion Island was the lowest in France (23.04 per 10,000 births), notably in relation to a young maternal age. However, if we look at live births, Reunion Island has the highest prevalence of DS in France (12.24 vs. 5.81 per 10,000 births), despite a well organized prenatal diagnosis (PND). In fact, the use of MToP in this context is the lowest in France (10.8 vs 26.3 per 10 000 births).

Local specificities may have an impact on the choice of patients to undergo or not undergo a MToP in the context of PND of DS and explain why the rate of recourse to MToP is the lowest in France. To date, no qualitative study exploring the reasons why women and their partners do not undergo a MToP in the context of DS has been conducted in Reunion Island.

Thus, the main hypothesis is that the low recourse to MToP following PND of DS in Reunion Island could be explained by the beliefs, values or choices of Reunion Island women and their partners during pregnancy in relation to a specific family, socio-cultural and economic context.


Eligibility Criteria:
Inclusion Criteria:

Parents:

* of a child born alive with Down Syndrome as of January 1, 2019 and registered within REMACOR
* living on the island of Reunion at the time of birth
* having a good understanding of French and/or Creole
* having given their written consent to the study

Exclusion Criteria:

Parents:

* with normal/negative prenatal screening (False positive)
* minors at the time of inclusion
* under guardianship or legal protection
* with a pathology preventing the interviews from taking place
Effect of Food Intake on Pharmacokinetic Profiles of Z-338

To evaluate the effects of food intake on plasma concentration of Z-338 in healthy volunteers.

The purpose of the study is to evaluate the influence of food intake on the pharmacokinetic profiles of Z-338 in healthy volunteers by a 3-way cross-over method.

Eligibility Criteria:
Inclusion Criteria:

* Healthy subject
* Body weight: 50.0 - 80.0 kg
* BMI: 17.6 - 26.4

Exclusion Criteria:

* Receiving an investigational new drug within 120 days of the study
* Receiving medical treatment drugs within 7 days of the study
* Blood donation before the study
Adaptive Decision Support for Addiction Treatment (ADAPT) Factorial Trial

This study is stage 1 of a larger study which refines and optimizes the EMBED\* clinical decision support (CDS; see NCT03658642) to increase number of ED physicians following standard of care for the administration of buprenorphine to appropriate patients with opioid use disorder.

This study does not have open enrollment. Investigators will use a Multiphase Optimization STrategy (MOST) framework study with preparation, optimization, and confirmatory phases. In the current project, optimization phase, stage1 investigators will conduct a 2x2x2 factorial trial in which they expand EMBED to include sustainable implementation strategies: nurse prompt for withdrawal assessment, and targeted clinician prompt to use the CDS along with patient resources to promote equity and motivate readiness to start treatment.

Later study phases will include optimization phase, stage 2: rapid-cycle randomized testing, and evaluation phase: a randomized trial of the optimized package compared to the original EMBED and the evaluation phase in which investigators will compare the efficacy of the optimized, multicomponent CDS package to the original EMBED CDS on ED-initiation of buprenorphine rates in patients with OUD in a randomized trial.

\*EMBED is a user centered, clinician facing clinical decision support system integrated into the electronic health record workflow to facilitate initiating buprenorphine in the emergency department by: diagnosing opioid use disorder with a checklist based on the diagnostic criteria of the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, fifth edition), assessing the severity of withdrawal with the Clinical Opioid Withdrawal Scale (COWS), motivating patients to accept treatment with a scripted brief negotiation interview, and automating the electronic health record workflow, including clinical and after visit documentation, order entry, prescribing, and referral for ongoing treatment in the community


Eligibility Criteria:
Inclusion Criteria:

* Emergency department patient
* 18 years of age or older
* Moderate to severe opioid use disorder

Exclusion Criteria:

* Under 18 years of age
* Pregnant
* Currently receiving medication for opioid use disorder