cyrilzakka/clinical-trials huggingface dataset:
Study of the Effectiveness of Three Different Doses of OPC-34712 in the Treatment of Adults With Acute Schizophrenia

The purpose of this study is to compare the effectiveness, safety and tolerability of three different doses of OPC-34712 with placebo in the treatment of acute schizophrenia in adults.

Schizophrenia is a severely debilitating mental illness that affects approximately 1% of the world population. Hallucinations and delusions are the most striking characteristic positive symptoms of schizophrenia; however, more subtle negative symptoms (eg, social withdrawal and lack of emotion, energy, and motivation) may also be present. The first antipsychotics developed for the treatment of schizophrenia were effective against positive symptoms, but showed little efficacy for negative symptoms and were also associated with a high incidence of side effects. Second generation antipsychotics, represent a significant advancement in the treatment of psychotic disorders because they are effective and at the same time exhibit fewer side effects than first generation antipsychotics. Although generally safer than first generation antipsychotics, the second-generation antipsychotics are not devoid of undesirable side effects such as Hyperprolactinemia and weight gain. In addition, the safety of these drugs vary considerably.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects between 18 and 65 years of age, with a diagnosis of schizophrenia, as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) criteria
2. Subjects who have been recently hospitalized or who would benefit from hospitalization for an acute relapse of schizophrenia
3. Subjects experiencing an acute exacerbation of psychotic symptoms
4. Other protocol specific inclusion criteria may apply

Exclusion Criteria:

1. Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving study drug
2. Subjects with a current DSM-IV-TR Axis I diagnosis of:

   * Schizoaffective disorder
   * Major depressive disorder (MDD)
   * Bipolar disorder
   * Delirium, dementia, amnestic or other cognitive disorder
   * Borderline, paranoid, histrionic, schizotypal, schizoid or antisocial personality disorder
3. Subjects presenting with a first episode of schizophrenia
4. Other protocol specific exclusion criteria may apply
Use of Noninvasive Brain Stimulation in Parkinson's Disease

The purpose of this research is to determine whether repetitive sessions of transcranial direct current stimulation (tDCS) to the prefrontal cortex can enhance the cognitive, affective and motor functioning of those with Parkinson's Disease.

In this study we will compare active tDCS with sham tDCS. Each subject will receive two consecutive weeks of stimulation (Monday through Friday). A battery of neuropsychological and affective tests will be administered throughout the duration of the study.

Note that this study is a two-center study (the other center is Beth Israel Deaconess Medical Center - PI - Alvaro Pascual-Leone)

\* Further study details are provided by Spaulding Rehabilitation Hospital.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of "probable" PD, defined by the presence of at least 2 out of 3 cardinal motor features of PD (resting tremor, rigidity, and bradykinesia, plus a sustained and significant response to dopaminergic treatment);
* Age 40 or over;
* Taking stable medications for at least 30 days

Exclusion Criteria:

* Features suggestive of other causes of parkinsonism/ parkinson-plus syndromes;
* History of deep brain stimulation or ablation surgery, mass brain lesions;
* History of schizophrenia, schizoaffective disorder, other psychosis, bipolar illness, alcohol/drug abuse within the past year;
* Need for rapid clinical response due to conditions such as initiation, psychosis, or suicidality;
* Contraindications to tDCS\*

  * metal in the head
  * implanted brain medical devices
* Unstable medical conditions (eg. uncontrolled diabetes, uncompensated cardiac issues heart failure, pulmonary issues, or chronic obstructive pulmonary disease)
* Pregnancy
Study of the Pronostic Impact of Immunohistochemical, Histological and Radiological Factors in Patients With Primary Central Nervous System Lymphoma.

Primary Central Nervous System Lymphoma (PCNSL) have a specific mutational profile in comparison to systemic diffuse large cells lymphoma (DLBCLs) that can be related to the expression of immunohistochemical markers as cyclon, NPM1, CD30, and P53 which could be predictive factor for prognosis and/or chemotherapy response. The main objective of this study is to identify new prognostic factors and new potential therapeutic targets.

The secondary objectives are to correlate the histological, the radiological and the clinical's informations of these patients.


Eligibility Criteria:
Inclusion Criteria:

* PCNSL diagnosed between January 2011 and December 2019, without regard to the clinical outcome.
* Age \> 18

Exclusion Criteria:

* Systemic DLBCL
Community-engaged Optimization of COVID-19 Rapid Evaluation and TEsting Experiences

Throughout the Coronavirus disease (COVID-19) pandemic, rates of COVID-19 have been persistently high in San Diego County's central and southern communities near the United States/Mexico border. These regions predominantly house Latino residents, the ethnic minority community most impacted by COVID-19 in San Diego. In the Phase I project, University of California, San Diego (UCSD) partnered with San Ysidro Health (SYH) and the Global Action Research Center, to co-create and demonstrate the impact of a COVID-19 testing program in San Ysidro, one of the most impacted areas from COVID-19 in San Diego County. To date, the project tested \>10,000 community members (92% Latino) and received requests to scale-out the testing program to additional primary care clinic sites.

In this Phase III project, Community-engaged Optimization of COVID-19 Rapid Evaluation And TEsting Experiences (CO-CREATE-Ex) will extend work with the Phase I community and clinical partners to refine, specify, implement, and evaluate an implementation strategy bundle that optimizes COVID-19 testing, expanding beyond current polymerase chain reaction (PCR) testing to FDA-authorized COVID-19 rapid antigen testing.

CO-CREATE-Ex will roll-out our implementation using 3 strategies:

1. keeping the current, walk-up free testing protocol
2. Offering Community Health Worker (CHW) to lead COVID-19 test counseling, preventive care reminders, and offer testing support
3. Installing vending machines that will dispense FDA-authorized self-testing kits.

For each strategy, participants will consent into study, provide demographics and test history, and receive a free rapid antigen test (RAT) kit. After receiving the test kit, participants will be prompted to return their results and fill out a survey about their COVID-19 experiences. Study subjects will be contacted up to three times over a course of 4 weeks to return their results and complete the survey. Study coordinators will use participants' preferred method of contact.

Eligibility Criteria:
Inclusion Criteria:

* Speak English and/or Spanish
* Affiliated with San Ysidro Health as a patient at select clinics (San Ysidro, Chula Vista, Lincoln Park, and Logan Heights) OR
* A member of a community near a San Ysidro Health clinic (San Ysidro, Chula Vista, Lincoln Park, and Logan Heights).

Exclusion Criteria:

* Institutionalization for psychiatric disorder, developmental delay, or criminal activity.
* Unable to provide informed consent.
Interprofessional Mindfulness Practices Advancing Cancer Teamwork

The purpose of the research is to understand if mindfulness team training can improve the well-being and teamwork in caring for oncology patients. This study will enroll healthcare professionals in oncology teams, including clinic nurses, nurse managers, medical assistants, social workers, technicians, patient navigators, advanced practice providers, and physicians at UW Madison. Participants will be on study for up to approximately 6 months.

Aim 1: Determine the effect of resilience training on team resilience and well-being. The investigators test the hypothesis that resilience training provided to interprofessional oncology care teams will improve team resilience and individual well-being.

Aim 2: Determine the feasibility and acceptability of a resilience training on team resilience. The investigators test the hypothesis that resilience training is feasible and acceptable in interprofessional oncology care teams.

Eligibility Criteria:
Inclusion Criteria:

* A care provider in an oncology clinic team (clinic nurse, nurse manager, medical assistant, technician, social worker, patient navigator, advanced practice provider, physician)

Exclusion Criteria:

* Does not participate in patient care or support services
Telehealth Treatment for Alcohol Use Disorder

Participants with alcohol use disorder will be randomly assigned to either the Ria Treatment Platform or a waitlist control. The Ria Treatment Platform is a telehealth approach that incorporates medical assessment, medications for alcohol use disorder, individual and group coaching, educational video modules, and a Bluetooth-enabled breathalyzer. Patients are followed for three months during which data are collected, including measures of alcohol consumption and its consequences.


Eligibility Criteria:
Inclusion Criteria:

* alcohol use disorder

Exclusion Criteria:

* inability to provide informed consent
Corticosteroids as an Additional Treatment for Mastoiditis In Children

The aim of the study is to assess the influence of adjuvant corticosteroid treatment in acute mastoiditis in children. we expect a better outcome in children treated with both corticosteroids and antibiotics including lower rates in complications and earlier decline in fever and inflammatory markers.

The research is a multi-centered, prospective, placebo-control, randomized controlled trial. The study group will be comprised of children diagnosed with acute mastoiditis and hospitalized in a pediatric medical center.

The participating patients will be randomized divided into two groups. Research group will be given dexamethasone treatment (course of 16 doses, 0.15 mg/kg/dose every 6 hours) in addition to antibiotic treatment. Control group will be given 16 doses of 0.9% normal saline in addition to antibiotic treatment. Management and treatment will be conducted according to clinical condition and laboratory findings as for routine institution protocols. It should be noted that the regular institutional management of children enrolled for the study will not be changed due to our research.

Eligibility Criteria:
Inclusion Criteria:

* acute mastoiditis

Exclusion Criteria:

* immunodeficiency (congenital or acquired)
* significant chronic disease
* hypertension
* recurrent mastoiditis
Post Marketing Surveillance Study of Biphasic Insulin Aspart 30

This study is conducted in Asia. The aim of this study is to review the safety and efficacy of biphasic insulin aspart 30 in post-marketing use.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with diabetes who did not have indications that are contraindicated in the product insert
Postoperative Analgesia With Local Infiltration After Periacetabular Osteotomy

Pain treatment after periacetabular osteotomy is traditionally based on systemic opioids wich have side effects. The purpose of this study is to evaluate the analgetic effect of wound infiltration with local anaesthesia after periacetabular osteotomy.


Eligibility Criteria:
Inclusion Criteria:

* Periacetabular osteotomy due to traditional dysplasia or retroverted acetabulum
* Informed consent

Exclusion Criteria:

* Intolerance of local anaesthesia
* Habitual use of opioids
Long-term Surgical Therapeutic Outcomes of Peri-Implantitis

This study focuses on evaluating the success of different treatment methods for peri-implantitis (gum disease around implants) and to understand the factors that might affect the success of the treatment provided.

Qualifying patients will be asked to participate in clinical measurements to compare the long-term success of their treatments.

The aims of the current study are to 1) assess the long-term outcome of the surgical treatment of peri-implantitis and to 2) evaluate the success of the different treatment modalities of peri-implantitis.

Eligibility Criteria:
Inclusion Criteria:

1. The patient is at least 18 years of age,
2. was initially diagnosed with peri-implantitis at ≥1 implant (peri-implant probing depth (PPD) ≥ 6 mm together with bleeding and/or suppuration on probing (BOP/SoP) and radiologically assessed marginal bone loss ≥ 3 mm),
3. had received treatment for peri-implantitis at least 5 years ago at the Graduate Clinic of Periodontics at University of Michigan, and
4. documentation from ≥ 5 years of clinical and radiological follow-up is available from U of M patients records.

Exclusion Criteria:

1. Has received or is currently receiving radiotherapy,
2. are currently pregnant, unsure of their pregnancy status, or are lactating (as reported by the patient),
3. has health condition(s) or takes medication(s) that are known to affect soft tissue or bone (e.g., Phenytoin)
Accuracy Testing of the Chromosomal Aberration and Gene Mutation Markers of the AMLProfiler

This clinical study will demonstrate the accuracy of the chromosomal aberration and gene mutation markers of the AMLProfiler molecular diagnostic assay and generate clinical performance data to support a Pre-Market Approval (PMA) submission to the Food and Drug Administration for in vitro diagnostic use within the United States of America.

The objective is to demonstrate the positive and negative percent agreement of each marker by comparing AMLProfiler results from multiple clinical participating sites with data generated using a laboratory developed bi-directional sequencing method generated at the molecular diagnostic reference lab.

The AMLProfiler assay is a qualitative in vitro diagnostic test for the detection of AML or APL specific chromosomal aberrations (specific recurrent translocations and inversions), as well as expression of specific genetic markers in RNA extracted from bone marrow aspirates of patients with Acute Myeloid Leukemia.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects with a cytopathologically confirmed diagnosis of AML subjects with refractory anemia with excess of blasts (RAEB) according to the WHO 2008 classification
2. ≥ 18 years
3. Written informed consent

Exclusion Criteria:

1. Subjects without a cytopathologically confirmed diagnosis of AML subjects with refractory anemia with excess of blasts (RAEB) according to the WHO 2008 classification
2. \< 18 years
3. Without written informed consent
Kagocel® for the Prevention of ARVI and Influenza in Adults Health Care Workers

this study evaluates the use of Kagocel for the prevention of acute respiratory viral infections (ARVI) and influenza during the epidemic rise in morbidity in Russia in the 2017-2018 season (epidemiology: number of cases during the period of taking Kagocel and follow-up, severity of the disease, bacterial exacerbations, number of repeated episodes (reinfection); patients demography; safety) in health care workers who are at risk.

This non-interventional prospective study included 204 health care workers over the age of 18 who had no symptoms of acute respiratory viral infections (ARVI) and influenza at the time of inclusion and had not taken any antiviral medications to prevent ARVI and influenza for 30 days before.

The total duration of the study was 2 months: the first month participants took either Kagocel (the main group), or did not take anything at all (the control group), during the next 1 month all participants were monitored.

The diagnosis of influenza and ARVI has been confirmed in accordance with the world health organization (WHO) guidelines for the pharmacological treatment of pandemic influenza A (H1N1) 2009 and other influenza viruses. All patient examinations are conducted in accordance with local routine clinical practice and local and international standards of care.

By the study were analysed and compared those data between groups:

* demography
* anamnesis data (the incidence of ARVI and flu, the date of the lastest episode of the disease, the presence of concomitant diseases, including ENT-organs, the date of the lastest influenza vaccination).
* timelines: start of Kagocel's prevention - only for the group receiving Kagocel's prevention, start of the disease, duration of ARVI and influenza symptoms (fever, headache, runny nose, sore throat, cough), start of treatment
* need for antiviral therapy (Yes/no)
* antiviral therapy (Yes/no, drug name)
* bacterial exacerbations (Yes/no)
* treatment of bacterial exacerbations (Yes/no)
* adverse events

Eligibility Criteria:
Inclusion Criteria:

* signed informed consent to participate in the study.
* age from 18 to 70 years.
* the subject of the study does not have symptoms of ARVI and influenza at the time of inclusion in the study.
* there are no contraindications to the use of Kagocel: pregnancy and lactation, hypersensitivity to the components of the drug, lactase deficiency, lactose intolerance, glucose-galactose malabsorption (only for the group receiving kagocel prevention).
* the subject of the study should not to take other medications to prevent colds and flu while participating in the study.
* no history of participation in a clinical trial of any drug less than 30 days prior to inclusion in this study.
* no history of treatment by interferon or interferon inducers less than 30 days prior to inclusion in this study.

Exclusion Criteria:

* no exclusion criteria except participating in a current clinical trial because of non-interventional study design
MAintAin Activity in Arthritis: A Feasibility Study

Best practice guidelines across the world always recommend those living with arthritis to be physically active. Research shows that being active can help people living with arthritis to do the things that they want to do for longer, reduce pain, improve quality of life and protect against getting other health conditions such as heart disease, lung disease and cancer. Whilst various exercise programmes support people with arthritis to be active most individuals reduce their level of PA after completion of a prescribed programme. Staying active in the longer-term is more difficult and there is often a decrease in activity over time. Research has shown that exercise programmes helping people to become active, such as exercise classes, may not always have the right approach and focus during the programme to help people to stay active long-term. It is important to understand if people with arthritis can be supported to maintain their activity levels well in to the future. The investigators have already spoken to people living with arthritis, people involved in arthritis care and those involved in promoting physical activity. The research team brought their feedback and the scientific literature together and shaped a new intervention that suits the needs of people with arthritis and helps them to continue to be physically active. The investiagtors will now ask people living with arthritis to try out the new intervention.

Participants will receive up to five coaching sessions that aim to support people with arthritis to maintain their PA after exiting a structured exercise programme. Sessions will be delivered within community venues in a group setting by a trained provider. Sessions will last approximately between 60 and 90 minutes and will be delivered over a period of approximately 4-months.

Participants may receive a smartwatch with an inbuilt step counter such as Fitbit and diary to record their daily steps or physical activity minutes. The diary will also be used to record physical activity maintenance goals, complete action plans and self-monitor progress to build new habits. Participants can continue to use their own smartwatch if they have one.

The research team are interested to know if the programme has any effect on the amount of activity people do over time as well as looking at factors which can help with the understanding of 'why' or 'why not' a PA intervention may have worked.


Eligibility Criteria:
Inclusion Criteria: Those who have exited from a supervised group-based exercise programme for arthritis.

-

Exclusion Criteria: Those aged under 18 years

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A Study of Gefapixant (MK-7264) in Adult Participants With Chronic Cough (MK-7264-030)

The primary objectives of this study are to evaluate the efficacy of gefapixant (MK-7264) in reducing cough frequency as measured over a 24-hour period, and to determine the safety and tolerability of gefapixant. The primary hypothesis is that at least one dose of gefapixant is superior to placebo in reducing coughs per hour (over 24 hours) at Week 24.

This study will have a main 24-week treatment period and a 28-week extension period of treatment (total treatment period of 52 weeks). Participants at selected sites and countries who complete the main and extension study periods may consent to participate in an observational, 12-week, Off-treatment Durability Study Period. Any assessments conducted in the observational period will be exploratory.

Eligibility Criteria:
Inclusion Criteria:

* Chest radiograph or computed tomography scan of the thorax (within 5 years of Screening/Visit 1 and after the onset of chronic cough) not demonstrating any abnormality considered to be significantly contributing to the chronic cough or any other clinically significant lung disease in the opinion of the principal investigator or the sub-investigator
* Has had chronic cough for at least 1 year with a diagnosis of refractory chronic cough or unexplained chronic cough
* Is a female who is not pregnant, not breastfeeding, not of childbearing potential, or agrees to follow contraceptive guidance
* Provides written informed consent and is willing and able to comply with the study protocol (including use of the digital cough recording device and completion of study questionnaires)

Exclusion Criteria:

* Is a current smoker or has given up smoking within 12 months of Screening, or is a former smoker with greater than 20 pack-years
* Has a history of respiratory tract infection or recent clinically significant change in pulmonary status
* Has a history of chronic bronchitis
* Is currently taking an angiotensin converting enzyme inhibitor (ACEI), or has used an ACEI within 3 months of Screening
* Has an estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m\^2 at Screening OR an eGFR ≥30 mL/min/1.73 m\^2 and \<50 mL/min/1.73 m\^2 at Screening with unstable renal function
* Has a history of malignancy ≤5 years
* Is a user of recreational or illicit drugs or has had a recent history of drug or alcohol abuse or dependence
* Has a history of anaphylaxis or cutaneous adverse drug reaction (with or without systemic symptoms) to sulfonamide antibiotics or other sulfonamide-containing drugs
* Has a known allergy/sensitivity or contraindication to gefapixant
* Has donated or lost ≥1 unit of blood within 8 weeks prior to the first dose of gefapixant
* Has previously received gefapixant
* Currently participating in or has participated in an interventional clinical study within 30 days of screening