cyrilzakka/clinical-trials huggingface dataset:
Personal Adherence Evaluation of Medication Use for Adult Bipolar Disorder Patients

This study will attempt to increase understanding of why bipolar disorder patients do or do not take their medications by conducting in-depth interviews with them.

Disruptive manic and depressive episodes prevent bipolar disorder (BPD) sufferers from living healthy, functional lives. Relapse rates for BPD are high, between 70% and 90%, with approximately half of those relapses occurring in the first 2 years after remission. High rates of relapse and no substantial improvements in illness outcomes for many patients despite advances in drug treatment may be related to a common problem: medication nonadherence. Nine in 10 individuals with BPD have seriously considered medication withdrawal, and one third of individuals with BDP do not take 30% or more of their prescribed medications. The researchers in this study will identify BPD patients who do not take their medications as prescribed and conduct interviews with them. By obtaining an understanding of subjective reasons for medication nonadherence, this study will pave the way for better interventions to ensure BDP patients take the medications that will help them.

Participation in this study will consist of a single visit, lasting between 1.5 and 3 hours. All participants will have a history of medication nonadherence. Participants will be asked to fill out questionnaires and undergo a structured interview with a researcher. The interview will be audio recorded. The questionnaires and interview will assess BPD symptoms, attitudes toward medications, and to what extent patients are taking their medications. Researchers will also measure the number of pills used in participants' prescriptions by counting how many pills are left in each prescription bottle.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of bipolar disorder (BPD) Type I or Type II, as determined by a standardized diagnostic interview, the Mini-International Neuropsychiatric Interview (MINI)
* Demonstrated history of poor medication adherence, as determined by self-report or clinician report. In this study, self-reported treatment nonadherence will be identified with the Tablet Routines Questionnaire (TRQ). Poorly adherent individuals will be defined as those who miss 30% or more of medication within either the past week or past month (those missing 30% or more within past week will be considered to be non-adherent over the past month). Clinician-assessed nonadherence will be identified via a clinician version of the TRQ to identify nonadherence of 30% or more over the past 30 days.
* BPD of at least 2 years' duration
* Treatment with medication to stabilize mood for at least 6 months
* A Clinical Global Impression (CGI-BP) overall bipolar illness score of 4 or higher

Exclusion Criteria:

* Unable or unwilling to participate in psychiatric interviews, as based on the clinical opinion of the investigator or the treating clinician
* High risk of suicide, as seen in factors such as active suicidal ideation, recent suicide attempt, or current suicidal intent or plan
* Inability to speak English
* Receiving treatment involuntarily
TARGETing Healthy Weight Loss in the Context of Food Insecurity

This pilot and feasibility study will collect information from food insecure, as well as food secure, women with obesity to detail their desires and needs for healthy weight reduction. Up to 60 women with obesity will be enrolled. Pennington Biomedical Research Center will coordinate this qualitative study and use focus groups discussion to collect formative data.


Eligibility Criteria:
Inclusion Criteria:

* Willing to provide written informed consent
* Female
* 18 to 65 years of age
* BMI ≥ 30 kg/m2
* Ability to read and write using English
* Willing to participate in focus group discussions
* Willing to be audio/video recorded

Exclusion Criteria:

* Male
* Currently pregnant
* BMI \<30 kg/m2
Efficacy of SAP Block Versus ESP Block in VATS Surgery

During VATS (Video assisted thoracic surgery) small incisions are made in the patient's chest through which a camera and instruments are inserted to allow a lung operation to be performed. Often patients experience a substantial amount of pain and difficult recovery after this type of operation. Anaesthesiologists sometimes use "Regional Anaesthesia" to minimise the pain and help patient recovery after the operation. This involves injecting local anaesthesia into the nerves around the chest wall to effectively numb that part of the chest. There is a variety of different locations on the chest wall where the local anaesthetic can be deposited and no study has measured whether one technique is better than the other in terms of improving patients' recovery experience. Our study compares two new techniques for Regional Anaesthesia after this type of surgery. Participants will be randomly assigned (like tossing a coin) to receive either a SAP (Serratus Anterior Plane) or ESP (Erector Spinae Plane) Block. Both techniques are described within last five years, but have never been compared for chest surgery

The Serratus Anterior Plane (SAP) Block has been claimed to be a safer, technically less demanding alternative to paravertebral block and thoracic epidural in the management of post operative VATS associated pain . Recently, another new block, the Erector Spinae Block (ESP Block) has been described for use in thoracic wall surgery. It has also been claimed to be easier to perform than these more traditional methods of regional anaesthesia. No study to date has compared ESP to SAP blocks in terms of efficacy of post operative analgesia after VATS surgery. Furthermore, patient-centres outcome studies now demand that researchers evaluate more than acute pain in the early postoperative period: A 15-parameter Quality of Recovery score (QoR-15) has been recommended as the optimum tool to evaluate overall patient-centres measures of recovery after surgery, including pain. This study will test the hypothesis that patients receiving ESP Block have higher QoR-15 scores and better post operative analgesia in comparison with patients receiving SAP Block after VATS surgery.

Eligibility Criteria:
Inclusion Criteria:

* Male and Female participants providing written informed consent,
* ASA grade 1- 4,
* aged over 18
* undergoing a VATS procedure under General Anaesthesia

Exclusion Criteria:

* Absence of informed written consent,
* pre existing infection at block site,-
* severe coagulopathy,
* allergy to local anaesthesia,
* pre existing neurological deficit,
* previous history of opiate abuse,
* pre existing chronic pain condition,
* pre-existing dementia \[because of need to co-operate in completing QoR-15 score day after surgery\].
Sexual Functions and Covid-19

Sexual health is one the important components of life quality. The aim of this study is to compare sexual dysfunction of women who survived Covid-19 and who didn't undergo Covid-19.

With identifying a new type of coronavirus, the infection disease known as Coronavirus disease-2019 (Covid-19) is still effective worldwide. Within the frame of the description that the health is "a complete physical, mental and social welfare," many physical and mental modality may be expected due to the pandemic and the measures against pandemic. Among them, sexual health is one of the basic indicative factors of human welfare. There are few data on sexual dysfunctions from the previous clinic pandemic experiences. From the very early stages of Covid-19 pandemic, health systems and researches focused on mortalities and short-term morbidities. Although there are similar studies about effects of pandemic on sexual behaviors of general community, there is no comparative study about the effects on sexual functions of women survived from Covid-19 and women having no Covid-19 history, yet. This study aims to compare women survived from Covid-19 and women having no Covid-19 history and having similar characteristics in terms of sexual dysfunctions.

Eligibility Criteria:
Inclusion Criteria:

* previously diagnosed for mild - medium Covid-19 infection and had ambulatory care
* being sexually active

Exclusion Criteria:

* having psychiatric disease
* having any malignity
* having endometriosis
* having a gynecologic surgery history
* having a previous sexual dysfunction
Probiotics Against Low Grade Inflammation and Increased Intestinal Permeability in the Elderly

The purpose of this study is to evaluate the ability of a blend of berries and probiotics in reducing low-grade inflammation and intestinal permeability in the elderly. The intervention period is one month. Blood and fecal samples will be collected for analysis at baseline and at the end of the intervention with the aim to analyse possible changes in different parameters at the two timepoints. The participants will also be asked to keep a study diary throughout the study period for the documentation of their intestinal health and as a means for checking compliance.


Eligibility Criteria:
Inclusion Criteria:

* Age \>75 years
* CRP 2-10 mg/L
* Ability to fill in a study diary by him/herself

Exclusion Criteria:

* Intake of antibiotic treatment in the last 4 weeks before inclusion into the study.
* Currently on corticosteroid treatment
* Presence of chronic inflammatory disease
Comparison of Optic Nerve Sheath Diameter in Children Receiving Caudal Block According to Anesthetic Agents: Total Intravenous Anesthesia vs. Volatile Anesthesia

Caudal block is commonly used for postoperative analgesia in paediatric patients. A higher volume (1.5 ml/kg) of local anaesthetic for caudal block has been reported to not only increase the level of cranial spread but also provide better quality and longer duration of analgesia in comparison with the conventional volume (1.0 ml/kg). However, caudal block with a high volume of local anaesthetic can increase intracranial pressure (ICP). Previous studies have shown that propofol anesthesia lowers ICP when compared with volatile anesthesia. Therefore, this study was designed to test if propofol can reduce the magnitude of ICP increase following caudal block when compared with a volatile anesthetic, sevoflurane. There is increasing evidence that optic nerve sheath diameter (ONSD) measured by ultrasonography correlates with degree of ICP and is able to detect intracranial hypertension. Therefore, ONSD will be measured as a surrogate of ICP.

Equal number of patients are randomly assigned to the P or S group. The participants in the P and S group are anesthetized with propofol and sevoflurane, respectively. Irrespective of assigned group, all participants receive caudal block with 1.5 ml/kg of 0.15% ropivacaine (up to 30 ml per individual participant). All anesthetic procedures except for main anesthetic agent are the same in all participants. ONSD is measured at the following time points: before (T0), immediately after (T1), and 10 min (T2) and 30 min(T3) after caudal block. Two measurements of each optic nerve sheath are acquired in each eye. The mean value of the four measurements is considered as the ONSD at each time point.

Eligibility Criteria:
Inclusion Criteria:

* Among children undergoing urological surgery, patients, 36 to 72-months-old
* Body weight less than 20 kg (The limit on body weight is set because the maximum volume of local anaesthetic for caudal block in children is restricted to 30 ml.)
* Treatment plan for caudal block for analgesia, are enrolled.

Exclusion Criteria:

* Symptoms or signs of spinal anomalies or infection at the sacral region
* Coagulopathy
* Increased ICP
* Ophthalmic diseases
* History of increased ICP
Wounds Protocol at Family Health Strategy Units in a Rio Grande do Sul Countryside Town

Evaluate the process for implementing a wound protocol for lesion control and cost-effectiveness in the context of the Family Health Strategy in the city of Santa Cruz do Sul, Brazil.


Eligibility Criteria:
Inclusion Criteria:

* Presenting vascular (venous, arterial or mixed) ulcers for over 1 year;
* Be available to have wounds dressed at the healthcare unit;
* Be a patient registered with the Family Health Strategy teams.

Exclusion Criteria:

* Have some condition rendering the patient unable to go to the unit, such as being bedridden or having had a lower limb amputated;
* Having decompensated diabetes mellitus;
* Having move away from the Family Health Strategy unit's coverage area.
The Arrhythmogenic Potential of Midwall Septal Fibrosis in Dilated Cardiomyopathy

Midwall septal fibrosis (MSF) is a common structural abnormality in non-ischaemic dilated cardiomyopathy (DCM). Its presence is believed to increase the risk of malignant ventricular arrhythmias (VA), but the mechanism of arrhythmogenicity is not known. This is particularly relevant in DCM patients with MSF and mid-range left ventricular ejection fraction (LVEF) as they do not currently fulfil criteria for a primary prevention implantable cardioverter-defibrillator (ICD) insertion.

Access to the epicardium for electrical measurements of the heart can enhance the understanding of arrhythmogenicity in DCM, however direct epicardial access is invasive. Instead, the investigators will non-invasively combine high resolution 256-lead ECG imaging (ECGI) and latest generation cardiovascular magnetic resonance (CMR) to study the hearts of 60 DCM patients with and without MSF regardless of LVEF, and 60 matched healthy volunteers. The investigators recently invented the re-usable and CMR-safe SMART-ECGI vest technology for this purpose. Using supercomputers, the investigators will fuse the collected ECGI/CMR data and run electromechanical simulations of whole-heart activation to non-invasively measure each participant's personalised risk of malignant VA induction.

By panoramically mapping the DCM heart in a single beat, the investigators aim to elucidate how MSF perturbs the cardiac activation front and how this could lead to life-threatening VA. This has the potential to change the method by which cardiologists risk stratify patients with DCM.


Eligibility Criteria:
Inclusion Criteria:

* Adults with dilated cardiomyopathy
* With and without midwall septal fibrosis on previous CMR

Exclusion Criteria:

* Needle-phobic patients that would preclude cannulation for contrast injection and blood taking
* anyone unwilling to consent
* anyone with a conventional contraindication for CMR
* anyone with any condition precluding full participation in the study such as DCM patients with infarct-pattern LGE, or subepicardial LGE or non-septal midwall fibrosis (participants with small volume right ventricular insertion point LGE will not be excluded).
MelPRO-0322 (CRISTINA Trial) [miCrobiome pRedIctS aPD1 effecTivnes In melaNoma pAtietns]

The goal of this observational study is to learn about if new biomarkers such as gut microbiota and molecular genetics melanoma features could predict clinical radiological and pathological response to neoadjuvant monotherapy with anti-PD1 agents in patients with resectable stage IIIB-D melanoma. The main questions it aims to answer are:

* radiological and pathological response rate to three doses of antiPD1 agents;
* do radiological and pathological responses correlate with gut microbiota and melanoma molecular genetics features Participants will receive three doses of aPD1 monotherapy as per center routine practice and will undergo regional lymphadenectomy. Before treatment initiation patients will be asked to bring faeces probes and fill out dietary questionnaire as well as just before the surgery.

After sugery adjuvant therapy will be prescribed for 12 month and patients will be followed up according to institutional routine practice for 5 years.

The clinical efficacy of PD1 inhibitors on the 2-year recurrence-free survival of patients with resectable stage III B-D melanoma will be assessed. This indicator will be compared with a historical control group using adjuvant PD1 immunotherapy and targeted therapy. Various factors will be analyzed for their potential impact on immunotherapy effectiveness, including demographics, disease stage and sub-stage, molecular-genetic status of the tumor, composition of the tumor\&#39;s lymphoid infiltrate, LDH levels, gut microbiome composition, radiological and pathological response to treatment, and the development of immune-mediated adverse events. These findings may help optimize treatment by implementing neoadjuvant therapy for stage III B-D cutaneous melanoma.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years and older.
* Performance status according to the Eastern Cooperative Oncology Group (ECOG) of 0-1.
* Patients who have not previously received immunotherapy with anti-PD1, anti-PDL1, or anti-CTLA4 agents.
* Clinical stage III (B-D), i.e., with clinically or radiologically determined metastatic changes in lymph nodes.
* Histologically confirmed involvement of regional lymph nodes.
* Lesions assessable by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

Exclusion Criteria:

* Patients with melanoma of non-skin localizations.
* Patients with active autoimmune diseases.
* Patients with active infectious diseases.
* Patients with severe concomitant diseases with an ECOG status \&gt;1.
* Pregnant or lactating patients.
* Patients requiring the intake of glucocorticoids at a dose greater than 10 mg of prednisone (or equivalent) per day.
* Patients requiring the use of, or having received, systemic antibiotics within 4 weeks prior to the start of the study.
A Trial to Evaluate the Safety and Preliminary Efficacy of iNK in the Treatment of Subjects With Solid Tumor

This trial is to investigate the safety, efficacy of iNK in subjects with solid tumor. It is a dose escalation and extension trial.

Solid tumor is a disease with high mortality rates. The aim of this trial is to investigate the safety, efficacy of iNK in subjects with solid tumor. It is a dose escalation and extension trial.

Eligibility Criteria:
Inclusion Criteria:

1. ≥18 years old.
2. Subjects with recurrent or metastatic solid tumors that cannot accept radical locoregional therapy;
3. Systemic standard treatment failed or cannot tolerate serious toxicity or lack of standard treatment.
4. Have 1 or more focus can be accessed according to RECIST 1.1
5. Eastern Cooperative Oncology Group(ECOG):0-1
6. Expected survival period over 3 months
7. Have acceptable organ function and the results of laboratory examination meet the request below:

   Hepatic Insufficiency (ALT) and Aspartate aminotransferase（AST）≤3xULN(upper limit of normal);Total Bilirubin≤3xULN；Creatinine≤3xULN；White blood cell count ≥3.0x10\^9/L; Absolute Neutrophil Count≥1.0x10\^9/L
8. Agree to contraception
9. Subjects who understand and voluntarily sign the Informed Consent Form（ICF)

Exclusion Criteria:

1. Central nervous system metastasis or meningeal metastasis with clinical symptoms；
2. With active infection during screening
3. Have serious or uncontrolled basic diseases;
4. Have continuous adverse event caused by previous anti-tumor therapy that might affect the evaluation of drug safety；
5. Accept anti-tumor therapy within 28 days before first injection;
6. Accept general anesthesia surgery or radiation therapy within 28 days before first injection;
7. Accept live vaccine or attenuated live vaccine within 28 days before first injection;
8. Allergy to known drug components;
9. Serous cavity effusion requiring clinical intervention；
10. Pregnancy or prepare to pregnant during the treatment;
11. Other situations that not suitable to participate into this trial.
Transvaginal Ultrasound and Photoacoustic Imaging of the Ovary

The investigators have developed co-registered photoacoustic and ultrasound (US) imaging technique that allows the investigators to visualize tumor structure and functional changes simultaneously, which may potentially reveal early tumor angiogenesis development that is not available by US alone. The ability to detect early angiogenesis changes, as well as tumor morphology changes in the ovary, using a non-invasive imaging modality will greatly enhance the care for women.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Referred to Washington University School of Medicine for conditions necessitating surgery to include at least a unilateral oophorectomy
* Willingness to participate in the study
* Able to provide informed consent

Exclusion Criteria

* Younger than 18 years of age
* Not able to provide informed consent
Effectiveness of Methylene Blue Guidance in Total Excision of Pilonidal Sinus.

Methylene bleu use in pilonidal sinus surgery is not an effective guidance as expected.

To study the potential benefits of intraoperative methylene blue use in pilonidal sinus surgery in detecting the borders of the disease, the histopathologic correlation between the specimen dyed by methylene blue and also the cavity excision specimen not dyed by methylene blue was investigated. The branches that distinctly exceeded the planned dyed excision borders will tried to be detected histopathologically, if any.

Eligibility Criteria:
Inclusion Criteria:

* Pilonidal sinus disease of the intergluteal region
* Primary disease without history of drainage
* Ages between 18 and 65, both gender

Exclusion Criteria:

* Recurrent pilonidal sinus disease
* Acute infection with abscess formation and/or purulent copious drainage
* Denial to sign informed consent
Testing the Effectiveness of a Computer-based Program for Depression

The purpose of this study is to determine whether completing a computer-based program alters changes how the brain processes emotional information and improves symptoms of depression.


Eligibility Criteria:
Inclusion Criteria:

* Major Depressive Disorder

Exclusion Criteria:

* Substance dependence, psychotic disorder, bipolar disorder, schizophrenia, current psychotherapy, medications other than selective serotonin reuptake inhibitors
Study of External Neuromodulation to Improve Signs and Symptoms of Dry Eye in Visual Display Terminal Users

Two study arms - sham and treatment; There will be a cross over of the sham group to the treatment group at day 15.

This is a post market study. The active device will be the FDA cleared device used within its labeling. The sham group will receive an iTEAR device which looks identical to and makes noise similar to a fully functional iTEAR device but has a tip that does not vibrate. All subjects in the sham group will crossover to the treatment group after 2 two weeks and all patients will continue to 30 days.

The study will be conducted at up to 5 sites in the United States. It will enroll 30 subjects for 30 days.

This is a double-masked study with 10 subjects receiving sham and 20 subjects receiving treatment. The subjects and the examining investigators are masked to treatment until the crossover.

Eligibility Criteria:
Inclusion Criteria:

* \> 6hrs visual display terminal
* OSDI \> 13
* One of: SChirmer \< 10, One quadrant staining \> 2, or Meibomian Gland expression \<12

Exclusion Criteria:

* Opinion of investigator that subject not be in the study