cyrilzakka/clinical-trials huggingface dataset:
Open-label, Extension Study of Aripiprazole Intramuscular Depot (OPC-14597, Lu AF41155) in Patients With Schizophrenia

The phase 3 Trial 31-12-291 is part of the aripiprazole IM depot clinical development program and has been designed to demonstrate the efficacy and safety of aripiprazole IM depot for the treatment of adults experiencing an acute relapse of schizophrenia. Subjects receive treatment during a 12-week double-blind acute treatment phase. The current trial (31-12-297) will allow the subjects who complete Trial 291 to enter this open label trial at the investigator's discretion, where additional safety and tolerability data will be collected.


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects 18 to 66 years of age, inclusive, at the time of informed consent.
* Subjects who are able to provide written informed consent (as required by IRB/IEC) prior to the initiation of any protocol-required procedures.
* Ability, in the opinion of the investigator, to understand the nature of the trial and follow protocol requirements, including the prescribed dosage regimens, tablet ingestion, and discontinuation of prohibited concomitant medication, and to be reliably rated on assessment scales.
* Subjects who have met the completion criteria in the 31-12-291 registrational trial for the acute treatment of adults with schizophrenia
* Subjects who, in the investigator's judgment, require chronic treatment with antipsychotic medication and would benefit from extended treatment with an IM depot formulation.
* Outpatient status at the Week 12 in Trial 291, with the exception of those subjects eligible to enter Trial 297 due to a positive interim analysis.

Exclusion Criteria:

* Sexually active males of childbearing potential who do not agree to practice 2 different methods of birth control or remain abstinent during the trial and for 180 days after the last dose of trial medication. Sexually active Women of Childbearing Potential who do not agree to practice 2 different methods of birth control or remain abstinent during the trial and for 150 days after the last dose of trial medication.
* Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving IMP in this trial.
* Subjects experiencing acute depressive symptoms within the past 30 days, according to the investigator's opinion, that requires treatment with an antidepressant.
* Subjects who are anticipated needing CYP2D6 or CYP3A4 inhibitors or CYP3A4 inducers during the course of the trial.
* Subjects with a significant risk of violent behavior; who represent a risk of committing suicide; or who in the clinical judgment of the investigator present a serious risk of suicide.
* Subjects requiring any antipsychotic(s) other than aripiprazole IM depot after completion of Trial 291.
* Subjects likely to require prohibited concomitant therapy during the trial
* Laboratory test and ECG results which are exclusionary
* Any subject who, in the opinion of the investigator or medical monitor, should not participate in the trial
Vorinostat and Palliative Radiotherapy

Phase I study. Side-effects when combined with standard palliative radiotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Pelvic malignancy
* Palliative radiation treatment planed
* ECOG \<3
* Age\>18 years

Exclusion Criteria:

* Previous pelvic radiotherapy
* Uncontrolled diarrhea
* Insulin-dependent diabetes mellitus
* BMI\<18.5
Bedside Screening Method for Patients With Potential Swallowing Impairment

Previous studies have shown that most patients with functional oropharyngeal dysphagia could be quickly, safely and accurately recognized by using a clinical bedside method developed by the investigative team as the volume-viscosity swallow test (V-VST) that systematically evaluates the main clinical signs and symptoms of safety and efficacy of swallowing and monitors pulse oximetry to improve the detection of patients with silent aspirations.The aim of this study is to validate this test for persons suspected of having swallowing impairment, using a new thickener, with respect to the Videofluoroscopy (VFS) method (treated as the gold standard).


Eligibility Criteria:
Inclusion Criteria:

* History of swallowing difficulties associated with aging and/or neurological diseases including patients with: -neurodegenerative diseases. -non-progressive neurological diseases including stroke. -older patients including nursing home patients.
* Age \> 18 y
* Ability to give informed consent

Exclusion Criteria:

* Patients suffering idiosyncratic phenomena or who are allergic to any medication, especially iodinated contrast media
* Patients suffering major respiratory disease or undergoing any type of surgery in the three months prior to the study
* Patients with a background of alcohol dependence or other drug dependence
* Patient who cannot be expected to comply with treatment
* Patient currently participating or having participated in another clinical trial during the last 4 weeks prior to the beginning of this study
Enhancing Gluteus Maximus Recruitment

Can participants enhance gluteus maximus recruitment during a single-leg squat test following a neuromuscular training program?


Eligibility Criteria:
Inclusion criteria

* female
* healthy, active individuals
* age 18-36
* walk without assistive device
* able to run, jump, squat without difficulty
* show evidence of hip muscle dysfunction on screening exam

Exclusion criteria

* history of knee ligament injury, knee surgery, patella dislocation
* knee pain traversing stairs, squatting or after prolonged sitting within 6 months of test
* joint line tenderness suggestive of meniscus pathology
* positive knee ligament stress tests
Prevalence of Temporomandibular Disorders in Patients With Fibromyalgia Syndrome

One Hundred Fifty woman patients diagnosed with fibromyalgia according to the American College of Rheumatology 2010 diagnostic criteria and 150 healthy woman volunteers will be included.Demographic data (age, gender, height, weight, marital status, education level) and duration of fibromyalgia diagnosis will be recorded. Patients will be evaluated according to the Diagnostic Criteria for Temporomandibular Disorders: Assessment Instruments (DCTMD: AI ). Patients will be evaluated by Diagnostic Criteria for Temporomandibular Disorders: Temporomandibular Disorders (TMD) Pain Screener, Symptom questionnaire, Clinical Examination Form from Assessment Instruments Axis I. Pain Drawing, Graded Chronic Pain (version 2), Jaw Functional Limitation Scale-8 (JFLS-8), Patient Health Questionnaire (PHQ-4), Oral Behaviors Checklist will be applied within the scope of Axis II.

In our study, the investigators aim to compare the frequency of temporomandibular disorders between healthy female participants and female patients diagnosed with fibromyalgia.

Our study will consists of 300 female participants aged between 18 and 65 years who applied to the physical therapy and rehabilitation outpatient clinic between May 2021 and August 2021. This case-control study will conducted according to the Declaration of Helsinki. Participants gave written voluntary consent and enrolled in this case-control study. One Hundred Fifty woman patients diagnosed with fibromyalgia according to the American College of Rheumatology 2010 diagnostic criteria and 150 healthy woman volunteers will be included. Patients with temporomandibular region surgery, congenital teporomandibular joint pathologies, and previous temporomandibular region trauma were will be excluded from the study. Because fibromyalgia is a disease that mostly affects women, the investigators designed our study so that all participants were women. In addition, demographic data (age, gender, height, weight, marital status, education level) and duration of fibromyalgia diagnosis will be recorded. Patients will be evaluated according to the Diagnostic Criteria for Temporomandibular Disorders: Assessment Instruments ( DCTMD: AI ). Patients will be evaluated by Diagnostic Criteria for Temporomandibular Disorders: TMD Pain Screener, Symptom questionnaire, Clinical Examination Form from Assessment Instruments Axis I. Pain Drawing, Graded Chronic Pain (version 2), Jaw Functional Limitation Scale-8 (JFLS-8), Patient Health Questionnaire (PHQ-4),Oral Behaviors Checklist will be applied within the scope of Axis II.

Eligibility Criteria:
Inclusion Criteria:

* One hundred fifty woman patients diagnosed with fibromyalgia according to the American College of Rheumatology 2010 diagnostic criteria
* One hundred fifty womanhealthy volunteers

Exclusion Criteria:

* Patients with temporomandibular region surgery
* Congenital teporomandibular joint pathologies
* Previous temporomandibular region trauma were excluded from the study.
3 Months Versus 12 Months Dual Antiplatelet Therapy After Drug-eluting Stent Implantation in STEMI

To compare the clinical outcomes of dual antiplatelet therapy with aspirin and P2Y12 receptor inhibitor vs. ticagrelor monotherapy at 3 months after PCI in patients with ST-elevation myocardial infarction.

The purpose of this study is to compare the use of ticagrelor alone versus P2Y12 receptor inhibitor and aspirin together after PCI among ST-elevation myocardial infarction patients who complete 3-month course of dual antiplatelet therapy. The object of this study is to determine the effectiveness and safety of ticagrelor alone, compared to P2Y12 receptor inhibitor plus aspirin in reducing clinically relevant bleeding and in reducing ischemic adverse events among patients diagnosed with ST-elevation myocardial infarction undergoing PCI with second-generation drug-eluting stent.

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 19 years old
* Patients who received new generation sirolimus-eluting (Osiro®) stent implantation for treating ACS
* Provision of informed consent

Exclusion Criteria:

* Age \> 80 years
* Pregnant women or women with potential childbearing
* Life expectancy \< 1 year
Stigma and Efficacy of Zhizhu Kuanzhong Capsules

Antidepressants are effective in patients with functional dyspepsia (FD), however, the stigma related with FD and antidepressants could affect treatment adherence and efficacy. Zhi Zhu Kuan Zhong capsules (ZZKZ), a traditional Chinese medicine fomula, showed therapeutic potential for FD. The study was designed to investigate whether ZZKZ could alleviate stigma in FD and obtain identical effects in patients with refractory FD.

Patients with dyspepsia have poor quality of life and emotional distress. The pathophysiology of FD is complex and multifactorial, including factors related to central nervous system and peripheral sensory system. Abundant drugs have been trialed to treat FD patients, but the treatment options remain limited and far from optimal. Antidepressants were beneficial in the treatment of FD. But the antidepressant prescriptions often aggravate the stigma of patients with FD, hinder doctor-patient communication, and reduce treatment compliance. Some patients with strong stigmatized feelings towards antidepressants refused to take the medications, and stigma related with antidepressants could ultimately affect the efficacy of FD. Zhizhu Kuanzhong capsules (ZZKZ), a commonly used traditional Chinese medicine (TCM) formula, had shown effectiveness in relieving dyspeptic symptoms. It has a long culture and history in promoting the function of brain and GI tract in whole, which is widely accepted by populations who were familiar with TCM. The study was designed to observe whether ZZKZ could alleviate stigma of patients and obtain identical effects in patients with FD, therefore provide a new insight in the treatment of FD.

Eligibility Criteria:
Inclusion Criteria:

* The inclusion criteria includes:
* 18-70 years old;
* education level higher than middle school;
* met the Rome IV criteria for FD;
* absence of abnormalities on physical examination, laboratory tests (including a routine blood test, blood glucose, and liver function examination), and abdominal imaging and GI endoscopy within 6 months;
* absence of Helicobacter pylori infection;
* signed written informed consent for participation in the study.

Exclusion Criteria:

* The exclusion criteria includes:
* evidence of organic digestive diseases;
* diabetes, cancer and other diseases might affect GI function;
* pregnancy, lactation or breastfeeding;
* a history of allergic reaction to any of the drugs used in the study;
* participation in other clinical trials in the previous 3 months.
Increasing the Winter Community Participation of Older Adult Wheelchair Users

The purpose of this study is to examine whether intervention strategies targeted at the level of the environment (e.g. improving access to community based leisure groups, transportation) can successfully promote the community participation experiences of community-dwelling older adult Manitobans who use wheelchairs in the winter.

There is strong evidence to support that community-dwelling older adults who are able to maintain their involvement in social, recreational, spiritual and physical activities experience positive effects on their health and quality of life. While winter creates challenges to community participation for many Manitobans, these difficulties are magnified for older adults and particularly for older adults who use wheelchairs. The aim of this study is to explore ways to improve or maintain community participation of community-dwelling older adults who use wheelchairs in the winter. Using a single-subject design, five older adult Manitobans who are wheelchair users will each select three community-based participation goals to work on throughout the winter months. Each older adult participant will work with an occupational therapist to receive individually-focused interventions aimed at increasing his or her community participation. The investigators will use a client-centered outcome measure designed to detect changes in performance and satisfaction in the goals that the individual has self-identified as being important to him or her, yet difficult to perform. The findings of this study will help determine the feasibility of conducting a larger scale study that would include a greater number of older adult Manitobans. Older adult wheelchair users in Manitoba bear a disproportionate burden in the winter when aging, mobility limitations, and weather coincide to create conditions that make community participation exceedingly difficult. It is important to the health and well-being of older adult Manitobans to find effective ways to promote community engagement throughout the winter months.

Eligibility Criteria:
Inclusion Criteria:

* Age 70 or older, user of a manual or power wheelchair or scooter for outdoor mobility
* Self-identifies a reduction in community participation throughout the winter months
* Community-dwelling
* Lives within the perimeter of Winnipeg.

Exclusion Criteria:

* Geriatric Depression Scale-SF score of 6 or more
* Montreal Cognitive Assessment score of 25 or less
Multicentric Retrospective Review of Extracapsular Lymph Node Involvement After Esophagectomy

It is well known that lymph node metastasis is one of the most important prognostic factors in oesophageal carcinoma.

The investigators want to determine the influence of lymph node characteristics, being either intracapsular or extracapsular, on overall survival after esophagectomy for esophageal cancer.

The classification of carcinoma of the esophagus has undergone a major modification between the UICC sixth (TNM-6) and TNM-7 edition. Regional lymph nodes (N) are now subdivided by the number of involved lymph nodes (pN0, 0; pN1, 1-2; pN2, 3-6; pN3 \> 6), and distant metastasis (M) has been simplified to M1 rather than subdivided by location \[1\].

Nevertheless, TNM-7 doesn't take into consideration the morphologic characteristics of the metastatic lymph node itself. Since our first publications showing a negative relationship between presence of extracapsular lymph node involvement (EC-LNI) and survival \[2\], little has been published about the prognostic impact of this specific characteristic .

In our latest publication "Can extracapsular lymph node involvement be a tool to fine-tune pN1 for adenocarcinoma in UICC TNM 7th Edition?" \[3\], the investigators found a significant survival benefit for adenocarcinoma without extracapsular lymph node involvement in pN1 (= 1-2 positive lymph nodes) as compared to N2-N3 disease, treated by primary surgery. Moreover, pN1 patients with extracapsular lymph node involvement (EC-LNI) showed a survival that was comparable to patients with more than 2 positive lymph nodes (i.e. stage IIIB). These findings may have important consequences for future TNM adaptations.

The aim of this study is to validate our results on a larger, multicentric cohort, and if possible make recommendations and possible fine-tuning for a future TNM adaptation, including the characteristics of the metastatic lymph node itself, being intra- or extracapsular.

Furthermore the investigators want to examine if these effects are valid in pre-treated patients, i.e. surgery after neoadjuvant chemo(radiation) therapy. Although these patients are not incorporated in the current TNM classification, future adaptations to the TNM classification system will also examine the effects of neoadjuvant therapy (cfr. Rice/Blackstone WECC -Worldwide Esophageal Cancer Collaboration).

Eligibility Criteria:
Inclusion Criteria:

* Adequate lymph node sampling is of paramount importance. (pT1 - min. 10 LN; \>pT2 min. 20 LN resected). At least the following lymph node stations should be examined: perioesophageal distal 1/3 and perigastric LN, left gastric artery, splenic artery, common hepatic artery, subcarinal lymph nodes. Sugical technique (transthoracic, transhiatal or minimal invasive) is less important if the criterium of adequate lymph node sampling is fulfilled but should be mentioned.

Exclusion Criteria:

* unforeseen organ metastasis
* subcardia tumors
* histology other than adenocarcinoma or squamous cell carcinoma
* Postoperative (inhospital or 30-day) mortality
Phase II Trial of Carbon-ion Radiotherapy Combined With GM-CSF for the Treatment of Hepatocellular Carcinoma

The aim of this research project is to assess the efficacy and toxicity of hypofractionated carbon-ion radiotherapy with concurrent granulocyte-macrophage colony-stimulating factor for the treatment of hepatocellular carcinoma

Golden E.B. et al.in 2015 reported that localized radiotherapy granulocyte-macrophage colony-stimulating factor (GM-CSF) produced objective abscopal responses in solid tumor with metastasises. We hypothesize that hypofractionated carbon-ion radiotherapy combining granulocyte-macrophage colony-stimulating factor (GM-CSF) might improve the clinical response rate and progression-free survival (PFS) in hepatocellular carcinoma. The primary endpoint of the current phase II trial is progression-free survival rate at 2 years, secondary endpoints are overall survival, safety and toxicity.

Eligibility Criteria:
Inclusion Criteria:

1. histologically confirmed hepatocellular carcinoma (HCC) or clinical diagnosis of HCC according to American association for the study of liver diseases （AASLD）-guidelines or clinical diagnosis criteria based on Alpha Fetoprotein （AFP), and radiological images proposed by Liver Cancer Society, Chinese Anti-Cancer Association;
2. no clinically distant metastasis;
3. the tumor is away from gastro-intestinal (GI) tract (\>1cm);
4. Child Push score A,technically unresectable, or medically inoperable; maximal tumor size is less than 10 cm;
5. age ≥ 18 and \<80 years of age;
6. Karnofsky Performance Score ≥ 70;
7. No previous invasive cancer (within 5 years before the HCC diagnosis)except for skin non-melanoma cancer or non muscle invasive bladder cancer; Ability to understand character and individual consequences of the clinical trial;
8. Willing to sign the written informed consent; Informed consent must be signed before the enrollment in the trial;

Exclusion Criteria:

1. Distant metastasis (M1);
2. maximal tumor size is more than 10 cm;
3. tumor invading adjacent gastrointestine (T4);
4. Child push score B or C;
5. Previous hepatic radiotherapy;
6. Severe systemic disorders;
7. Previous malignancy (within 5 years) except for skin non-melanoma cancer or 3-year disease free interval from previous malignancy like in situ cervix cancer or non muscle invasive bladder cancer;
8. Non conformity of the radiotherapy dose distribution when compared to the dose constraints;
9. Psychiatric disorders or any other condition that can make unreliable the informed consent;
Phase 3 Safety and Immunogenicity Study of aQIV in Elderly Adults

This phase 3 study is a randomized, double-blinded, comparator controlled, parallel-group, multicenter study of aQIV versus the US-licensed 2017-2018 adjuvanted trivalent influenza vaccine (aTIV-1, Fluad), and versus an adjuvanted trivalent influenza vaccine (aTIV-2), containing the alternate B strain.


Eligibility Criteria:
Inclusion Criteria:

* Males and females ≥ 65 years old who are healthy or have co-morbidities
* Individuals who or whose legal representative(s) have voluntarily given written consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry
* Ability to attend all scheduled visits and to comply with study procedures including diary card completion and follow-up

Exclusion Criteria:

* History of behavioral or cognitive impairment or psychiatric condition
* Hypersensitivity, including allergy, to any component of vaccines, medicinal products or medical equipment whose use is foreseen in this study
* Abnormal function of the immune system
* Receipt of any influenza vaccine within 6 months prior to enrollment in this study, or plan to receive influenza vaccine prior to the Day 22 blood collection
* Any other clinical condition that, in the opinion of the Investigator, might interfere with the results of the study or pose additional risk to the subject due to participation in the study

Additional eligibility criteria may be discussed by contacting the site.
The Nature of Reflux-respiratory Symptoms Association in Difficult to Treat Wheezing\Coughing Babies

GER and respiratory symptoms are both common phenomenon in children. Both can coexist in the same patient by chance alone. Research reveals increased incidence for both to coexist leading to suspect a temporal association and possible causality. Therefore we conducted an observational study To determine the primary cause (RS or GER)using for the first time both PH-Impedance as measurements of GER and Wheezy monitoring (WEEM) that records simultaneously wheeze and cough noises. Both modalities will be recorded for 12-24 hours. If GER precedes cough/wheeze recordings it points to GER being the possible precipitating factor and vice versa.

GER and respiratory symptoms are both common phenomenon in children. Both can coexist in the same patient by chance alone. Research reveals increased incidence for both to coexist leading to suspect a temporal association and possible causality. Therefore we conducted an observational study To determine the primary cause (RS or GER)using for the first time both PH-Impedance as measurements of GER and Wheezy monitoring (WEEM) that records simultaneously wheeze and cough noises. Both modalities will be recorded for 12-24 hours. If GER precedes cough/wheeze recordings it points to GER being the possible precipitating factor.However, If cough/wheeze precedes GER recordings it points to cough/wheeze being the possible precipitating factor. The recordings will be investigated 1 minute before and one minute after each event.

Eligibility Criteria:
Inclusion Criteria:

* Children 1 month - 18 years old
* Difficult to treat asthma
* Difficult to treat cough
* Difficult to treat other respiratory symptoms

Exclusion Criteria:

* Children on artificial ventilation
* Children not compliant with PH-Metria and/or WEEM