cyrilzakka/clinical-trials huggingface dataset:
Financial and Mental Health: Exploratory Research

This project will develop a model for providing low-income people with mental illness with supports that enable them to manage their money as well as possible so that they are better able to meet their basic needs, to experience less anxiety about finances, and to live fulfilling lives in the community with the greatest possible degree of independence. The project will work within a citizenship-oriented approach to mental health care, which promotes recovery through linking people with mental illness to the rights, responsibilities, roles, resources and relationships necessary to achieve full membership in society. The aims of the project are to: train clinicians and peer staff so that they are able to integrate discussion of financial issues and concerns into their work with clients; provide on-site services including financial counseling, peer support groups, help with opening a bank account, and a savings club, and; develop a 'financial health' model which can be replicated by other providers of mental health services. The investigators hypothesize that the intervention will result in improved financial health, reduced financial stress, increased community participation, and improved satisfaction with care.

This study will pilot and assess financial health interventions that will provide clients with financial counseling, and information about and access to financial management tools within the framework of citizenship-oriented care, which approaches recovery by linking clients to the 5 Rs of rights, responsibilities, roles, resources and relationships needed to achieve full membership in society. Based on results of previous research, the investigators hypothesize that the intervention will result in improved financial health, reduced financial stress, increased community participation, and improved satisfaction with care for the target group.

Eligibility Criteria:
Inclusion Criteria:

* All participants will be adults (18 years or older).
* Participants will be clients receiving services from the CMHC.
* The investigators intend to include clients who do not have a representative payee and who are employed, or receiving supported employment services at CMHC, or interested in employment

Exclusion Criteria:

* factors that compromise an individual's ability to provide informed consent such as a co-occurring organic brain syndrome or dementia
* age under 18, as the mental health center serves adults only.
Benefit of ESP Peri Operative Analgesia for Live Liver Donor Transplantation

Liver donors have a significant risk to develop persistent and chronic pain around 20 to 30% affecting social and professional life (17%) up to 1 year after the surgery.

To donate a part of liver is a beautiful gift reason why the pain relief must be improved.

Meta-analysis showed that the best prevention against post operative chronic pain are the techniques blocking the pain signal (regional anaesthesia) Patients after liver donation are still in pain even in 2020 with the best multimodal analgesia medications.

Erector sinae Plane Block (ESP) ESP will block the signal and improve the pain relief we hope to demonstrate that it will reduce the risk to develop post operative chronic pain and improve the quality of recovery and the quality of life after liver donation

1. Goals:

   Compare quality of pain relief and quality of life between bilateral ESP bilateral catheters Vs Opioid analgesia in donor patients for liver donation.
2. Methodology:

   • Selection criteria: Age \> 18 years old Be volunteer to donate liver Agree to participate in the trial

   • Exclusion criteria: Use of chronic opioids Contra-indication tom perform ESP catheter (Infection near puncture point, Severe thoracic scoliosis, allergie to local anesthestics) A diagnosis of a chronic pain conditionDepression or other psychiatric diagnosis

   • Study design: Prospective Randomized Controlled Trial.

   Patients who agree to join the study will be randomized into 2 groups:

   Group 1 (Control group): standard of care in liver donation : Intraoperative analgesia by Opioid sufentanil and post operative analgesia by PCA opioid morphine Group 2 (treatement group): Standard peri-operative analgesia for liver donation in since Investigators use regional anaesthesia as first line treatement for peri operative analgesia Bilateral ESP catheters with continuous regional analgesia by infusion of local anesthestic (Ropivacaine)

   Sample size: investigators expected to increase the Quality of LIfe (QoL) score (using under-the-curve area) from 36·9 for the ERAS group to 38.3 for ESP group The sample size of 10 patients per group is required to detect such changes assuming a confidence interval of 95% with a power of 90% and alpha = 0.05. Considering 20% of drop-out, the total sample size is 24 patients (12 patients each group)
3. Project outcomes:

   * Primary outcomes Quality of pain relief with opioid consumption
   * Secondary outcomes Duration of hospitalisation participants satisfaction Quality of recovery (QOR 16) Pain at 1 \& 3 months rest and mobilization + QOL

Eligibility Criteria:
Inclusion Criteria:

* age more than 18 and less than 61
* Be volunteer to donate liver
* agree to participate to study and consent signed
* Risk of americain society of anesthesiologists score ASA from 1 to 5 score ASA must be 1 only

Exclusion Criteria:

* Use of chronic opioid before the surgery
* A diagnosis of chronic pain condition
* Contra indication to perform ESP catheter
* allergy to local anesthestics
* Depression or psychiatric diagnosis
Outcomes Study of Late Effects After Proton RT for Pediatric Tumors of the Brain, Head, and Neck

The purpose of this study is to collect information from medical records to see what effects proton beam radiation has on cancer and analyze possible side effects.

Data collection will be obtained from the patient's medical records including initial evaluation, radiotherapy completion records and follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Estimated \>5 cc of the brain tissue to receive \>5 CGE radiation
* Patient must be less than 21 years of age at time of consent.
* Patients that require localized and craniospinal irradiation.
* Patients and/or patient parent must complete baseline Quality of Life Questionnaire as applicable by patient age group.

Exclusion Criteria:

* Prior radiation therapy.
* Evidence of metastases outside the central nervous system.
Venous Ethanol for Ventricular Tachycardia

Comparative effectiveness randomized clinical trial, comparing endocardial radiofrequency ablation alone vs radiofrequency ablation combined with venous ethanol in patients with ischemic ventricular tachycardia -Venous Ethanol for Left Ventricular Ischemic Ventricular Tachycardia -VELVET clinical trial

Patients with ventricular tachycardia (VT) in the context of ischemic heart disease suffer from significant morbidity and mortality. Catheter ablation can improve outcomes but has suboptimal ablation results. Ethanol ablation via epicardial veins can add significant therapeutic value to catheter ablation by increasing reach to intramural VT substrates. Investigators will randomize patients with ischemic VT to either endocardial catheter ablation alone, or combined with venous ethanol (VE) ablation of coronary veins located on the epicardial aspect of the VT substrates. A combined primary endpoint: VT recurrence, procedural complications, hospitalization for cardiac causes, and death, will be measured over a 12-month follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Male and female, ages of 18 and 85 years and with a prior ICD implant
* Diagnosed with ischemic cardiomyopathy: Prior myocardial infarction (pathological Q waves or imaging evidence of regional myocardial akinesis/thinning in the absence of a non-ischemic cause)
* One of the following VT events (within last 6 months): a) ≥3 episodes of VT treated with anti-tachycardia pacing (ATP) or anti-arrhythmic drugs; b) ≥1 appropriate ICD shocks; c) ≥3 VT episodes within 24 hr; d) sustained VT below detection rate of the ICD documented by EKG/cardiac monitor
* Patients deemed candidates for RF ablation of VT
* Able and willing to comply with pre-, post-, and follow-up requirements
* Willing to sign the informed consent

Exclusion Criteria:

* Serum creatinine \>1.5 mg/dL, or creatinine clearance \<30 ml/min
* Left ventricular (LV) ejection fraction ≤10%
* Mobile LV thrombus on echocardiography
* Absence of vascular access to the LV
* Disease process likely to limit survival to \<12 months
* New York Heart Association class IV heart failure
* Cardiac surgery within the past 2 months (unless VT was incessant),
* Acute coronary syndrome in the past 2 months (acute thrombus diagnosed by coronary angiography, or dynamic ST segment changes demonstrated on EKG)
* Another reversible cause of VT (e.g. electrolyte abnormalities, drug-induced arrhythmia)
* Severe aortic stenosis or mitral regurgitation with a flail leaflet
* Pregnancy
* Unwilling or unable to provide informed consent
* Covid-19 positive testing within 14 days of randomization procedure
* Enrolled, or planning to get enrolled, in another research study during his/her participation on the Velvet trial
Motor Imagery and Action Observation on Lumbar Motor Variables

Motor imagery is defined as a dynamic mental process of an action, without its real motor execution. Action observation evokes an internal, real-time motor simulation of the movements that the observer is perceiving visually. Both MI and AO have been shown to produce a neurophysiological activation of the brain areas related to the planning and execution of voluntary movement in a similar manner how the real action.


Eligibility Criteria:
Inclusion Criteria:

The inclusion criteria were as follows:

* asymptomatic participants
* men and women aged 18 to 65 years.

Exclusion Criteria:

The exclusion criteria included the following:

* participants who had any knowledge of Physical Therapy or Occupational Therapy
* underage participants
* participants with any symptomatology in the lumbo-pelvic region at the time of the study -participants with lumbo-pelvic pain in at least the prior six months
* subjects who have been treated for lumbo-pelvic pain in the previous 6 months
* participants with any type of neurological disease.
A Randomized Trial of Avastin + Gemcitabine + 5-Fluorouracil (5FU)/Folinic Acid Versus Avastin + Oxaliplatin + 5FU/Folinic Acid in Metastatic Colorectal Cancer

The purpose of the study is to describe the tumor response rates for the two regimens being studied, and to determine how long patients live after receiving the treatment, how long patients are without return of their disease after they receive treatment, and how long the response they get from the treatment lasts. The amount and type of side effects/toxicities of each regimen will also be evaluated. The regimen including Oxaliplatin + 5FU/Folinic Acid is a current standard of care.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have a histological or cytological diagnosis of the colon or rectum with Stage III unresectable or Stage IV disease.
* Urinalysis or Urine dipstick for proteinuria of less than 1+ (i.e. either 0 or trace). If urine dipstick is greater than 1+, the 24 hour urine protein must demonstrate less than 500 mg of protein in 24 hours to allow participation.
* No prior chemotherapy, immunotherapy, or hormonal treatment for metastatic disease is acceptable. However, one prior neo-adjuvant or adjuvant treatment is acceptable, including Capecitabine, Camptothecin-11 (CPT-11), 5 Fluorouracil/Leucovorin (5FU/LV) or Radiation containing regimens, (but no Oxaliplatin), and only if progression \> 6 months since last adjuvant treatment.
* Prior radiation therapy, including radiation to the whole pelvis, is allowed (Cristy and Eckerman 1987) and patients must have recovered from the acute toxic effects of the treatment prior to study enrollment. Prior palliative radiation therapy given to a non-measurable diagnostic site is acceptable if given \> 4 weeks prior to treatment or if other non-irradiated measurable disease is present.
* No known central nervous system (CNS) metastasis.

Exclusion Criteria:

* Histology other than adenocarcinoma
* Tumors that demonstrate free perforation as manifested by free air or free fluid in the abdomen. Patients with walled-off perforation are eligible.
* Gastroduodenal ulcer determined as active by endoscopy.
* Invasive procedures defined as follows; major surgical procedures, open biopsy, or significant traumatic injury within 28 days prior to randomization, anticipation of need for major surgical procedure during the course of study, core biopsy or other minor procedure within 7 days prior to registration.
* Following cardiac condition; New York Heart Association (NYHA) Class III or IV, myocardial infarction (MI) within 6 months, unstable angina within 6 months and current symptomatic arrhythmia.
CPAP In-home Assessment Australia

The study is to evaluate the product reliability, therapy effectiveness and user feedback of a Continuous Positive Airway Pressure (CPAP) device in-home for up to 6 months.

Existing and Naïve CPAP users will be recruited into a 6 month in-home study Participants will attend 5 study visits at day 0, 7, 30, 60 and 180. Outcome of the clinical investigation include downloadable device data reports, device error reports and participants perception questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 and over.
* Diagnosed with OSA by a practicing physician and prescribed Positive Airway Pressure (PAP) therapy.

Exclusion Criteria:

* Persons contraindicated for Continuous Positive Airway Pressure (CPAP) therapy.
* Persons with other significant sleep disorder(s) (e.g. periodic leg movements, insomnia, central sleep apnea).
* Persons with obesity hypoventilation syndrome or congestive heart failure.
* Persons that require supplemental oxygen with their CPAP device.
* Persons with implanted electronic medical devices (e.g. cardiac pacemakers).
* Persons who are pregnant or think they might be pregnant.
* Persons whose primary language is other than English.
* Persons in existing dependent or unequal relationships with any member of the research team, the researcher(s) and/or the person undertaking the recruitment/consent process.
* Persons highly dependent on medical care.
* People with cognitive impairment, an intellectual disability or a mental illness
A Study to Compare Laparoscopic to Echographic Assisted Transversus Abdominis Plane Block in Laparoscopic Colectomy

The purpose of this study is to compare the postoperative pain, the time needed and other clinical outcomes in patients who, during laparoscopic colectomy, will be injected with a local anesthetic (Ropivacaine) through an ultrasound guided technique performed by the anaesthesiologist or throught a laparoscopic assisted technique performed by the surgeon


Eligibility Criteria:
Inclusion Criteria:

* Patients candidates to laparoscopic colorectal surgery
* Signed informed consent

Exclusion Criteria:

* Age \< 18 years old
* Pregnancy
* Allergy to local anaesthetics
* Spinal or epidural analgesia
* Acute inflammatory abdominal pathologies
* Chronic pain syndrome
* Contraindications to nonsteroidal anti-inflammatory drugs (NSAIDS)
Impact of Preoperative VFA on Intraoperative Adverse Events in Patients Undergoing Laparoscopic Radical Gastrectomy

Preoperative visceral fat area (VFA) is associated with an increased incidence of postoperative complications in gastric cancer (GC). However, the relationship between VFA and intraoperative adverse events (iAEs) remains unclear. Therefore, this study aimed to evaluate the impact of preoperative VFA on iAEs in patients undergoing laparoscopic radical gastrectomy for GC, using data from two prospective trials. Simultaneously, a predictive model for iAEs was constructed to provide a basis for the early identification of high-risk populations and the implementation of personalized perioperative management measures.

A post hoc analysis was performed using data from two previous prospective studies (\[NCT02327481\] and \[NCT01609309\]). The patients were divided into high- and low-VFA groups. All iAEs were reviewed from the surgical videos and graded using ClassIntra. Logistic regression analyses were used for the construction of nomograms as predictive models.

Eligibility Criteria:
Inclusion Criteria:

This study comprised two prospective trials conducted at Fujian Medical University Union Hospital (FMUUH): the FUGES-001 study (ClinicalTrials.gov, NCT02327481) and a subset of the CLASS-01 multicenter study (ClinicalTrials.gov, NCT01609309)

Exclusion Criteria:

1. open surgery;
2. non-adenocarcinoma gastric cancers
3. Palliative surgery
4. Exploratory operation
5. CT data missing
Study With Intravenous Busulfan And Fludarabine Myeloablative Conditioning Regimen For HLA Identical Sibling Donor HSCT

Analyze the results of conditioning with once-daily dose intravenous busulfan and fludarabine in patients undergoing HLA identical sibling Allogeneic HSCT for myeloid malignancies.

In this study the investigators evaluate a conditioning regimen consisting in Fludarabine 40 mg/m2 once daily i.v in 60 min. on days -6 to -3 (total dose 160 mg/m2), followed by Busulfan 3,2 mg/kg once daily i.v. in 180 min. in the same days (total dose 12,8 mg/kg). No busulfan pharmacokinetic monitoring is performed. Graft versus host disease prophylaxis consists in the combination of cyclosporine and methotrexate. Graft products obtained from bone marrow or peripheral blood of HLA identical sibling donors are not manipulated in their cellular content before transplantation. Blood products were leukocyte depleted and irradiated before transfusion. Supportive care, including seizure prophylaxis, isolation measures, antiemetics, antimicrobial agents and growth factors use are followed according to standard procedures.

The main objectives are to record data regarding engraftment, regimen related toxicity and outcome in different patient populations according to age, disease type, disease status at HSCT and comorbidities.

Eligibility Criteria:
Inclusion Criteria:

* Acute Myeloid Leukemia
* Myelodysplastic Syndrome
* Myeloproliferative Disorders
* Chronic Myeloid Leukemia

Exclusion Criteria:

* Performance status ECOG\>2
* Cardiomyopathy (LVEF \<39%)
* Pulmonary dysfunction (DLCO\<39%)
* Hepatic dysfunction Grade \>1
* Renal dysfunction Grade \>1 (Creatinine \> 1.6 mg/dl)
* HIV infection
* Other active neoplasm
Comparative Effect of 3 Different Cranberry Extracts on Cystitis Related Urinary Comfort in Women

Urinary discomfort includes a set of signs such as an urgent need to urinate, high frequency of urination per day, discomfort / difficulty or burning sensation when urinating, smelly urine. This urinary discomfort represents in women 2 to 5% of the reasons for consultation (Berg, 1991) and can have various etiologies but the bacterial origin is the most frequent. Cranberries are traditionally used for urinary comfort and the prevention of urinary disorders with bacterial origin.

The study objective is to collect in real life efficacy and tolerance data from the consumption of 3 cranberry extracts in order to highlight the qualitative and quantitative characteristics of these extracts which are directly involved in the improvement of urinary discomfort or situation of recurrent cystitis symptomatic episodes in women.


Eligibility Criteria:
Inclusion Criteria:

* having had at least 3 symptomatic episodes of cystitis (including 1 urinary tract infection confirmed by a doctor) during the last 12 months
* whose episode had a significant impact on quality of life / urinary discomfort (ACSS Dimension QoL ≥ 2)
* had a smartphone compatible with Nurstrial smartphone application (e-CRF)

Exclusion Criteria:

* to be a pregnant or breastfeeding woman or planning to be pregnant within 6 months,
* currently taking any other supplementation for urinary comfort or having taken any other cranberry-based food supplement in the past 3 months,
* to be under antibiotic treatment or during the last 7 days preceding inclusion,
* have urinary discomfort with a severe impact on quality of life (ACSS QoL\> 7) during the last 24 hours prior to inclusion,
* have an allergy known to plants of the cranberry family or to one of the components of the products.
2 Phase Use Of Educational Materials In Head And Neck Cancer Center

The goal of this study is to assess the experience of our patients with head and neck cancer in regard to the information they receive, their symptoms, and their understanding of their diagnosis, to determine ways to improve upon these aspects of patient care in the future.

There will be two phases of the study. In "Phase I", 30 participants will be recruited for assessment of information satisfaction, psychological stress, illness perception, and symptom burden throughout their head and neck cancer treatment without any intervention. This group will represent the current standard of care in the head and neck group and serve as a "historical control" for the second group. In "Phase II", which will occur after "Phase I" group, 30 new participants will be recruited to receive a handbook and to have it integrated into their cancer care. The same participant reported outcome measures of information satisfaction, psychological stress, illness perception, and symptom burden will be assessed such that comparisons between phases can be made. This will serve as a pilot study of the implementation and maintenance of an educational intervention in clinical practice and how it affects participant-reported outcomes. Comparison of these two groups of participants will provide the baseline data to plan future interventions.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (greater than 18 years old) with a new diagnosis of head and neck cancer.
* Patients who have a treatment plan including both chemotherapy and radiation.
* Patients who will be undergoing treatment at Massachusetts General Hospital Cancer Center.
* Ability to speak and read in English in order to be able to complete questionnaires with minimal assistance required from a family member.

Exclusion Criteria:

* Patients with head and neck cancer who have a treatment plan only including single modality therapy (ie just radiation, just surgery, or just systemic therapy)
* Patients who cannot speak, read and write in English with minimal assistance from a family member.
* Patients with cognitive impairment that would preclude the patient signing informed consent or understanding the materials.
* Patients who will not be receiving their cancer treatment at MGH.
Effect of Functional Lumbar Stabilization Exercises in Women With Menstrual Low Back Pain

Menstrual low back pain (LBP) is one of the common complaints among women. Menstrual LBP may be attributed to the spinal instability resulting from ligament laxity due to hormonal change. The purpose of this study was to investigate the effect of functional lumbar stabilization exercises on pain, disability and kinesiophobia in women with menstrual LBP.

Pain intensity using Numeric Pain Scale (NPS), Oswestry disability index (ODI), Roland-Morris questionnaire (RMQ) and Tampa scale of kinesiophobia (TSK) were collected at base line and at the end of treatment (after three months) in both groups.

Eligibility Criteria:
Inclusion Criteria:

* Having low back pain LBP during menstrual phase (days 1-6) of the menstrual cycle.
* Suffering from low back pain during all menstrual cycles in the year before the study.
* No back pain or low back paiun at times other than the menstrual phase.
* Pain intensity during menstrual LBP greater than 5 in Numeric Pain Scale

Exclusion Criteria:

* History of spinal surgery, spinal or pelvic fracture and hospitalization for severe trauma or car accident, urinary tract infection, vaginal infection and known neurological disorders.
* Pain intensity lesser than 5 in Numeric Pain Scale