cyrilzakka/clinical-trials huggingface dataset:
A Study of the Effectiveness and Safety of Risperidone in the Treatment of Adolescents With Schizophrenia

The purpose of the study is to assess the safety and effectiveness of risperidone (an antipsychotic medication) in adolescents with schizophrenia over 6 months of treatment.

Although the safety and effectiveness of antipsychotic medications is well-established in adults with schizophrenia, these drugs have not been examined rigorously in adolescents with this disorder. Preliminary experience suggests that risperidone may hold promise for the treatment of these younger subjects. This is an open-label, multicenter trial of risperidone, formulated as an oral solution and tablets, in the treatment of adolescents with schizophrenia. It is an open-label, 6-month extension of two previous double-blind studies that assessed the safety and effectiveness of risperidone in the treatment of schizophrenia in an adolescent population. Patients may also enroll directly in this open-label trial. During the first week of the study, patients will receive increasing doses of risperidone to reach an optimal daily dose (2 to 6 mg/day), which will be maintained throughout the 6 months of the study. Assessments of effectiveness include the Positive and Negative Syndrome Scale for Schizophrenia (PANSS), a scale measuring the symptoms of schizophrenia, the Clinical Global Impression-Severity of Illness subscale (CGI-Severity), a scale measuring the severity of illness, the Clinical Global Impression-Improvement subscale (CGI-Improvement), a scale measuring clinical improvement, and the Children's Global Assessment Scale. Safety evaluations include the incidence of adverse events throughout the study, clinical laboratory tests (hematology, biochemistry, and urinalysis), vital signs (blood pressure, pulse, and temperature), weight, and electrocardiogram (ECG) recordings at specified intervals. The study hypothesis is that risperidone with be effective in the treatment of adolescents with schizophrenia, and well tolerated. Risperidone, oral solution (1 mg/ml) once daily; dose increasing from 0.01 mg/kg body weight (Day 1) to a range from 2 to 6 mg/day for 6 months. Oral tablets (0.5, 1, 2, 3, and 4 mg) once daily; dose increasing from 0.5 mg (Day 1) to a range of 2 to 6 mg/day for 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of schizophrenia by criteria of Diagnostic and Statistical Manual of Mental Diseases, 4th edition (DSM-IV)
* expected to benefit from continuous treatment with risperidone, including patients who cannot tolerate their current antipsychotic therapy or are still exhibiting symptoms
* Positive and Negative Syndrome Scale for Schizophrenia (PANSS) score between 40 and 120 at start of study (not required for patients continuing from the 2 previous studies)

Exclusion Criteria:

* Meet criteria for other psychiatric disorders or mental retardation (documented IQ \<70)
* history of substance dependence (including alcohol, but excluding nicotine and caffeine)
* hypersensitivity or intolerance to risperidone
* extrapyramidal symptoms (EPS) such as tremor that are not adequately controlled with medication
Prospectively Predict the Immunotherapy Response of Gastric Cancer Based on Circulating Exosomal LncRNA-GC1 Biopsy

To vertify the function of circulating exosomal lncRNA-GC1 on predicting and monitoring immunotherapeutic outcomes of GC

The investigator's previous work identified circulating exosomal lncRNA-GC1 as a GC-specific tumor burden marker and this novel biomarker showed promising efficiency in monitoring disease progression during treatment.

Hence in this stuty, the investigator plan to recruit a prospective cohort to support the conclusions, and provide biomarkers to realize predicting and monitoring immunotherapeutic outcomes of GC.

Eligibility Criteria:
Inclusion Criteria:

* Having signed informed consent
* Age≥ 18 years old
* Histologically confirmed gastric adenocarcinoma
* Unresectable recurrent or metastatic disease
* Measurable disease according to the RECIST criteria
* Life expectancy of ≥3 month
* No prior chemotherapy of the study more than 4 weeks
* Immunotherapy regimens were included in the treatment

Exclusion Criteria:

* Other previous malignancy within 5 year
* Surgery (excluding diagnostic biopsy) within 4 weeks prior to study
* Pregnancy or lactation period
* Legal incapacity
Effectiveness of 5% Dextrose Water Versus Corticosteroid Injection for Pain Management of SJD

The sacroiliac joint (SIJ) is identified as a potential origin of low back pain and referred pain to the lower limb, with a prevalence rate ranging from 7% to 30%. Typically, SIJ pain manifests in the buttock and occasionally extends to the posterior aspect of the ipsilateral thigh, resembling pain originating from lumbar spine sources, such as the zygapophysial joints or intervertebral discs.

For Sacroiliac Joint Dysfunction (SIJD) by examining the comparative effectiveness of two distinct interventions: the innovative 5% Dextrous Water (D/W) solution and the conventional corticosteroid injection. With corticosteroids associated with well-documented side effects and concerns about long-term use, the exploration of 5% D/W is particularly timely and holds promise as a potentially safer alternative.

Eligibility Criteria:
Inclusion Criteria:

* persons with SIJ pain for at least 3 months

Exclusion Criteria:

* Pregnancy or breastfeeding
* history of allergy or people contra indicated to our dose
* already received Corticosteroid injection in last 3 months
AESOPS Trial 2 (AESOPS-2): Availability of Opioid Harm

The opioid epidemic is the largest man-made public health crisis the United States has faced. The objective of Trial 2 of the Application of Economics \& Social psychology to improve Opioid Prescribing Safety (AESOPS-2) study, is to discourage unnecessary opioid prescribing by increasing the salience of negative patient outcomes associated with opioid use.

In AESOPS-2, a multi-site study, random assignment determines if prescribers to persons who suffer an opioid overdose (fatal or nonfatal) learn of this event (intervention) or practice usual-care (control). The AESOPS-2 trial will take place in 3 diverse health systems in the U.S. - Northwestern Medicine, AltaMed Health Services, and The Children's Clinic. At Northwestern Medicine, clinicians in the intervention group receive a letter notifying them of their patient's fatal or nonfatal ED overdose. At AltaMed Health Services, and The Children's Clinic, clinicians in the intervention group receive a letter notifying them of their patient's nonfatal ED overdose. The primary outcome is the change in clinician weekly milligram morphine equivalent (MME) dose prescribed in 6-month periods before and after receiving the letter. The secondary outcome is the change in the proportion of patients prescribed at least 50 daily MME. Group differences in these outcomes will be compared using an intent-to-treat difference-in-differences framework with a mixed-effects regression model to estimate clinician MME weekly dose. The AESOPS-2 trial will provide new knowledge about whether increasing prescribers' awareness of patients' opioid-related overdoses leads to a reduction in opioid prescribing. Additionally, this trial may better inform how to reduce opioid use disorder and opioid overdoses by lowering unnecessary population exposure to these drugs.

Eligibility Criteria:
Inclusion Criteria:

* 1) The clinician prescribed a qualifying scheduled drug to a patient in the 12 months prior to their non-fatal or fatal overdose 2) the patient is 18 years old or older at the time of the overdose, 3) the provider practices within a health system enrolled in the study, and 4) the overdose occurs during the 12-month observation period. Qualifying prescriptions include those for one of the following scheduled drugs: opioids, benzodiazepines, muscle relaxants or sedative-hypnotics.

Exclusion Criteria:

* Prescriptions to patients in hospice or with active cancer
Motivational Interviewing in Orthodontic Patients

The purpose of this study is to determine whether motivational interviewing is effective in improving oral hygiene in orthodontic patients wearing fixed appliances.


Eligibility Criteria:
Inclusion Criteria:

* Orthodontic patients wearing fixed appliances, within the first six months of treatment
* Eruption completed (except for the third molars) or late mixed dentition.
* Caucasian

Exclusion Criteria:

* Pregnancy
* Periodontal disease
* Systemic illness
* Medical treatment
Natural History Study of Infants and Children With Developmental and Epileptic Encephalopathies

This is a multicenter, prospective, 2-year observational study in infants and children with developmental and epileptic encephalopathies (DEEs). The DEE currently being investigated is SCN1A-positive Dravet Syndrome.

This prospective, longitudinal, natural history master protocol has been designed to define the seizure, neurodevelopmental, and behavioral characteristics of SCN1A-positive Dravet Syndrome in infants and children between 6 and 60 months. It will also explore the impact of the disease on the participant's parent/caregiver quality of life (QoL) and healthcare resource utilization (HCRU).

Eligibility Criteria:
Inclusion Criteria:

* Aged between 6 months and 60 months.
* Confirmed SCN1A mutation.
* Normal development prior to onset of first seizure as defined by the Centers for Disease -Control and Prevention (CDC 2019).
* Onset of seizures between age 3 and 15 months, inclusive.

Exclusion Criteria:

* Copy number variant of SCN1A, including SCN1A microdeletion, if affecting other genes.
* SCN1A mutation present on both alleles.
* Known pathogenic or clinically suspected mutation in a seizure-associated gene besides SCN1A.
* Confirmed mutation in a gene besides SCN1A that is known to increase the severity of the seizure phenotype.
* Known gain-of-function genetic mutation, as defined by functional studies, including p.Thr226Met.
* History of notable developmental deficit that was evident prior to seizure onset.
* Known central nervous system structural abnormality as found on magnetic resonance imaging or computed tomography scan of brain.
* Currently taking or has taken for 6 or more consecutive weeks anti-seizure medications (ASMs) at a therapeutic dose that are contraindicated in SCN1A-positive Dravet Syndrome, including sodium channel blockers.
* Known concomitant genetic mutation or clinical comorbidity that potentially confounds typical Dravet phenotype.
Increasing Lean Protein Intake in Preschool-age Children and Assessing Effects on Cognition and Select Health Outcomes

The proposed project addresses the goal of exploring preschooler's ability to recognize changes in feelings of hunger/satiety based on consuming a snack and a meal (lunch/dinner) that are either based on the usual childcare center fare (control) or are based on lean meats (intervention), which will have a lower glycemic index.


Eligibility Criteria:
Inclusion Criteria:

* child 2-5 years old

Parent participants:

* Parents of at least one child aged 2-5 years old
* Parents can communicate in English.
* Parents in households who do not have a cultural/ religious reason to abstain from to consuming pork

Exclusion Criteria:

* Child participants:
* Food allergies
* Taking medication that affects food intake (such as stimulant medications),
* Children with diabetes or impaired glucose control.
* Children with digestive disease (such as Crohn's)
* Dietary/religious preferences that exclude consumption of pork

Parent participants:

- Dietary/religious preferences that exclude consumption of pork
Opioid Misuse in Patients with Cancer

The success of opioid treatment in terminally ill cancer patients set the stage for extending the same treatment principles to the treatment of all chronic pain conditions including chronic non-cancer pain and chronic pain in cancer, where survival and long-standing chronic disease trajectories are getting more prevalent due to increasing survival rates. In this context, opioid misuse as such has been highly neglected - especially in palliative care, but also in cancer pain management in general. Previous studies have explored the literature on opioid misuse among adult cancer patients, noting that the available evidence is still in its early stages. Limited prospective studies with a wide range of definitions and methodologies for assessing misuse exist. Therefore, it seems highly relevant and justified to study the prevalence of opioid misuse risk in patients with cancer. The hypothesis of this study is that opioid misuse is not uncommon in Danish patients in treatment with opioids for cancer-related pain. Thus, the prevalence of opioid misuse risk among patients with cancer in Danish palliative care units will be investigate.

This is a prospective and cross-sectional study, in which opioid misuse is defined according to National Institute on Drug Abuse (USA) as the use of prescription opioids in a manner other than as directed by a doctor (e.g., for other purpose than pain relief, in greater amounts, more frequently, longer, using someone else's prescription). The aims are:

1. Investigate the prevalence of opioid misuse risk by the Pain Medication Questionnaire (PMQ) and the Opioid Risk Tool (ORT) among patients with cancer in palliative care units in Denmark.
2. Determine whether there is a correlation between the PMQ and ORT scores and opioid consumption, use of short-acting opioids (prn-dosing), tobacco smoking, alcohol consumption, previous consumption of illicit drugs and/or consumption of benzodiazepines and benzodiazepine-like hypnotics, and information provided by the physician regarding the patient's opioid misuse.
3. Investigate the association between opioid misuse risk (PMQ and ORT scores), depression and anxiety (Patient Health Questionnaire for Depression and Anxiety, PHQ-4), and health-related quality of life (EORTC-QLQ-C15-PAL).

Eligibility Criteria:
Inclusion Criteria:

* Outpatients ≥ 18 years,
* patients who are treated with opioids due to cancer-related pain.

Exclusion Criteria:

* Patients who do not master the Danish language in speech and writing,
* Patients who have severe cognitive dysfunction,
* Patients who are not treated with opioids,
* Patients who refused to participate in the study.
A Study to Determine the Difference in Low Contact Stress (LCS) Duofix Versus Low LCS Porocoat Knee Systems

The primary objective of this investigation is to test the hypothesis that the Duofix Tibial component results in a reduction of immediate postoperative pain compared to the LCS Porocoat version.

The secondary objectives of this investigation are to evaluate the clinical and patient outcomes, biological fixation and survivorship associated with the LCS Duofix and Porocoat knee system over 10 years.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects.
* Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained.
* Subjects who, in the opinion of the Investigator, are able to understand this investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups.
* Subjects who present with idiopathic osteoarthritis, rheumatoid arthritis, post traumatic arthritis or any other pathology that in the opinion of the clinical investigator requires a primary total knee arthroplasty and who are considered suitable for treatment with a cementless mobile bearing knee system (LCS Complete).
* Subjects who in the opinion of the Clinical Investigator are considered to be suitable for treatment with both the investigational devices, according to the indications specified in the package insert leaflet.

Exclusion Criteria:

* Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this study.
* Subjects with a known history of poor compliance to medical treatment.
* Women who are pregnant.
* Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes.
* Subjects involved in Medical-Legal claims.
* Subjects who have participated in a clinical study with an investigational product in the last month.
* Subjects who are currently involved in any injury litigation claims.
* Revision of an existing knee implant.
Study of the Pharmacodynamic Activity of P-321 Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye Disease

The purpose of this Phase 2a study is to assess changes in tear volume by the non-invasive techniques Ultra High Resolution Optical Coherence Tomography (UHR-OCT) following the administration of P-321 Ophthalmic Solution or Placebo in subjects with tear deficient dry eye disease.

This is a single-center, randomized, cross-over placebo controlled study to evaluate the changes in tear volume by P-321 Ophthalmic Solution and Placebo. The study will enroll subjects with tear deficient dry eye disease to receive sequentially one of two treatment sequences: P-321 Ophthalmic Solution then Placebo or Placebo then P-321. The study will consist of two Phases: In each Phase, subjects will be treated with P-321 Ophthalmic Solution under the same study design.

Approximately twenty-four eligible subjects will complete the study with approximately 8 subjects participating in Phase 1 and the remainder of the 24 subjects participating in the phase 2. Decisions on the dose to be used in Phase 2 will be made based on Phase 1 data.

The study will consist of three study visits: a Screening Visit (Visit 1), and two treatment visits (Visit 2 and Visit 3). The primary and secondary outcome measures will be assessed at each treatment visit. Safety assessments include adverse events (AEs).

Eligibility Criteria:
Inclusion Criteria:

1. Provide written informed consent
2. Male or female subjects aged 18 to 80 years
3. Have a history of predominantly tear-deficient dry eye of mild to moderate severity, supported by a previous clinical diagnosis
4. Have normal lid anatomy
5. Subjects must:

   1. Remain on current medications for the duration of the study and have been on the current medication regimen at least during the past 28 days

Exclusion Criteria:

1. Have undergone refractive eye surgery in either eye during the past 12 months
2. Have undergone uncomplicated cataract surgery in either eye during the past 3 months
3. Have undergone previous eyelid surgery in either eye (External blepharoplasty, not resulting in exposure or abnormal blinking is allowed)
4. Have undergone botulinum toxin (BotoxTh1 or equivalent) injection in the periocular area within 3 months prior to Visit 1
5. Subjects that have a systemic, multi-organ disease requiring active medical or surgical treatment are excluded with the exception of subjects with SS or GVHD
6. Have punctal plugs, punctal occlusion, history of nasolacrimal duct obstruction or wear scleral lens.
7. Past or present exposure keratopathy, neurotrophic keratopathy, lagophthalmos, or trichiasis
Taxotere Prostate Cancer New Indication Registration Trial in China

To compare overall survival after receiving mitoxantrone and prednisone or docetaxel and prednisone in subjects with hormone-refractory metastatic prostate cancer.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically proven prostate adenocarcinoma
* Androgen independent prostate Cancer S/P orchiectomy and/or LHRH agonist Testosterone \< 50 ng/dl (ie 1.735 nmol/l)
* Documented progressive disease
* Patients should have achieved stable analgesia for 7 days
* Karnofsky Performance Status ≥ 70
* No prior treatment with cytotoxic agent (except estramustine)
* Normal cardiac function must be confirmed by Left ventricular ejection fraction
* Adequate organ function:

  1. Hematology:

     * Neutrophils \> 1.5 x 10\^9/L
     * Hemoglobin \> 10 g/dl. Erythropoietin use is allowed, but red blood cell transfusion to upgrade the hemoglobin level is not allowed
     * Platelets \> 100 x 10\^9/L
  2. Hepatic function:

     * Total bilirubin \< the upper-normal limit of the institution.
     * Alanine aminotransferase and Aspartate transaminase \< 1.5 times the upper-normal limit of the institution.
  3. Renal function:

     * Creatinine \< 1.5 times the upper normal limit (ie National Cancer Institution grade \< 1)
* No brain or leptomeningeal metastases

Exclusion Criteria:

* Prior radiotherapy to \>25% of bone marrow (whole pelvic irradiation is not allowed)
* prior cytotoxic chemotherapy, except monotherapy with estramustine
* prior isotope therapy
* history of another cancer within the preceding five year
* symptomatic peripheral neuropathy grade ≥ 2
* other serious illness or medical condition:

  1. Congestive heart failure even if controlled. Previous history of myocardial infarction or angina pectoris within 1 year from study entry, uncontrolled hypertension or uncontrolled arrhythmias.
  2. Active uncontrolled infection
  3. Peptic ulcer, unstable diabetes mellitus or other contraindications for the use of corticosteroids.
  4. Auto-immune disease (lupus, sclerodermia, rheumatoid polyarthritis)
* treatment with any other anti-cancer therapy
* treatment with bisphosphonates

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Skin Testing and ELISPOT Assay in Patients With a History of Non-Immediate Reactions to Cephalosporins

This study aims to compare the results of skin testing and ELISPOT assay in patients with a history of non-immediate reactions to cephalosporins

Patients with a history of non-immediate reactions to cephalosporins will be tested by patch test and/or intradermal test. Peripheral blood mononuclear cells will be collected to analyzed cytokine secretions by ELISPOT assay

Eligibility Criteria:
Inclusion Criteria:

1. Patients with a history of non-immediate hypersensitivity reactions to cephalosporins
2. At least 18 years of age

Exclusion Criteria:

1. Suffering from severe systemic disease/ in bad health
2. Being pregnant
3. Patients with a history of immediate reactions to cephalosporin