cyrilzakka/clinical-trials huggingface dataset:
Impact of Real-time Notification of Colonoscopic Optical Diagnosis on Patients' Anxiety and Depression After Polypectomy

The accuracy of endoscopic optical diagnosis for colorectal polyps has been approaching histological diagnosis after implementation of image enhancement endoscopic technologies. The real-time notification of possible nature of resected polyp after colonoscopy is expected to reduce the anxiety and depression level of the patients before the availability of histological diagnosis and improve their quality of life. We designed and conducted a randomized control trial to confirm this hypothesis.

This is a single center, open-label, prospective and parallel randomized controlled trial. This study planning to recruit outpatients from the age of 40 to 79 who are scheduled to undergo sedated colonoscopy. Once eligible subjects were diagnosed of colorectal polyps during colonoscopy and received polypectomy, they will be randomized into "ordinary care group (explained at next scheduled clinic)" and "real-time notification group (explained immediately after colonoscopy)". The level of anxiety, depression of the two groups will be measured by using the Taiwan version questionnaire of Hospital Anxiety and Depression Scale (HADS) right before the next scheduled clinic for histological results and compared the difference between the two groups.This study is expected to determine the impact of real-time notification of colonoscopic optical diagnosis on patients' anxiety and depression after polypectomy, and provide evidence to improve post-polypectomy care.

Eligibility Criteria:
Inclusion Criteria:

* Age of ≥ 40 years and \< 80 years
* Outpatients who prepare receiving sedated colonoscopy
* Subjects who have signed informed consent form of this study
* Informed consensus has been obtained that endoscopic resection should be performed if a colorectal polyp is found
* Eastern Cooperative Oncology Group (ECOG) performance status scale among 0 to 2

Exclusion Criteria:

* Subjects with any of the following prior history or current conditions:
* (a) Contraindications to colonoscopy
* (b) Major mental illnesses, e.g. major depressive disorder, schizophrenia, generalized anxiety disorder ...
* (c) Inflammatory bowel disease
* (d) Hereditary or non-hereditary polyposis syndrome, hereditary non-polyposis colorectal cancer
* (e) Uncured colorectal cancer
* (f) Active gastrointestinal bleeding
* (g) Pregnancy
* Subjects who do not received polypectomy during colonoscopy.
Minimally Invasive Superficial Venous Insufficiency Surgery and Digital Sedation

Virtual reality has been shown to reduce the pain experienced during medical procedures.

The aim of this study is to determine to what extent the use of this technique could make it possible to defer the administration of neuroleptanalgesia during the endovenous thermal treatment of superficial varicose veins in addition to local anaesthesia by tumescence.

The main objective of the study is to test the non-inferiority of the effect of sedation by the virtual reality device on the intensity of maximum intraoperative pain compared with the usual neuroleptanalgesic treatment, tolerating a margin of non-inferiority of 0.5 points.Pain will be assessed on an ENS immediately at the end of the surgical procedure.

Prospective, randomised, open-label, single-centre study in two parallel groups of 200 patients.

Maximum duration of patient participation in the study = 2 days.

Eligibility Criteria:
Inclusion Criteria:

* Patient aged 18 or over, who has read and signed the consent form for participation in the study after a reflection period (approximately 1 hour).
* Outpatients with superficial venous insufficiency for which a surgical indication has been given
* Patient requiring sedation associated with local anesthesia

Exclusion Criteria:

* Contraindication to local anesthesia or any of the sedatives used in the protocol
* Hearing or visual impairment contraindicating use of the virtual reality headset
* Pregnant or breast-feeding patients
* Unbalanced epilepsy
* Patients under court protection, guardianship or curatorship
* Patients not affiliated to the French social security system
* Patient unable to understand informed information and/or give written informed consent: dementia, psychosis, disturbed consciousness, non-French-speaking patient
Virtual Reality and Spinal Stimulation to Improve Arm Function

The main objective of our work is to develop and test the safety and feasibility of a home-based upper limb rehabilitation program for individuals with tetraplegia. The program will consist of simultaneous non-invasive spinal cord stimulation and immersive virtual exercises of the upper limbs, with a focus on shoulder and elbow function.


Eligibility Criteria:
Inclusion Criteria:

1. incomplete low tetraplegia (C5-8; \[ASIA\] classification B-D),
2. free of contraindications to transspinal stimulation,
3. more than one-year post-injury,
4. stable medication regimen for the past month,
5. utilization of wheelchair as a primary mode of mobility (\>75% of the time). -

Exclusion Criteria:

1. Neurologic injury other than spinal cord injury
2. severe medical illness.
ACE-Inhibitor Effects on Total Hip and Knee Arthroplasty Patients

The purpose of this study is to determine the effects of Angiotension Converting Enzyme Inhibitors (ACE-I) during surgery and in the immediate postoperative period for patients undergoing elective total hip or knee arthroplasty.


Eligibility Criteria:
Inclusion Criteria:

* Patients electing to undergo primary or revision total hip or knee arthroplasty
* Currently taking an ACE-I

Exclusion Criteria:

* Trauma patients
* Immunosuppressed patients (HIV/AIDS, organ transplant recipients, chemotherapy patients, chronic steroid use)
* Patients with history of severe hypertension related illness such as hypertension associated with stroke or myocardial infarction
* Patients in who continuation of their ACE-I is expressly mandated by their prescribing physician
A Socio-ecological Approach for Improving Self-management in Adolescents With SCD

The goal of this clinical trial is to evaluate the impact of SCThrive (a behavioral self-management intervention) on patient activation, self-management behaviors, daily functioning, and emergency room visits in 260 adolescents and young adults with sickle cell disease (SCD) ages 13-21 receiving care at 1 of 4 pediatric SCD clinics.

The main question\[s\]it aims to answer are:

* Does SCThrive improve patient activation?
* Does SCThrive improve self-management behaviors, daily functioning, and decrease emergency room visits?
* Are any improvements maintained 3 months after treatment?

Participants will complete self-management related surveys before, after, and 3 months following their participation in an 8- week, virtual group intervention with an accompanying mobile app (SCThrive).

Researchers will compare outcomes for participants who receive SCThrive and participants who receive uniform standard care (SCHealthED which = standard of care plus SCD educational text messages) to see if there are differences in patient activation, self-management behaviors, daily functioning, and emergency room visits.

The research team's pilot work demonstrated improved patient activation (knowledge, skills, and self-efficacy) and self-management behaviors in adolescents and young adults (AYA) with sickle cell disease (SCD) compared to a control condition. Further analyses revealed that participants who used the app more frequently showed greater improvements. Thus, this study will maximize the clinical benefit of SCThrive by 1) adding app engagement strategies, 2) conducting a more systematic assessment of barriers including social contributors to health, and 3) integrating ways to address these barriers into the intervention.

Study Aims: The aims are to examine the impact of SCThrive on patient activation (primary outcome; Aim 1) and self-management behaviors, daily functioning, and emergency room visits (secondary outcomes) at post-treatment and follow-up (Aim 2). It is hypothesized that adolescents randomized to SCThrive will have greater improvement in patient activation (primary outcome) compared to those randomized to uniform standard care (control condition). The research team will also explore the relationship between social determinants of health (SDOH)-related barriers (e.g., stigma, access to care) and treatment response (i.e., patient activation and self-management behaviors).

Eligibility Criteria:
Inclusion Criteria:

* Patient of a participating SCD Clinic
* Confirmed diagnosis of SCD
* 13-21 years of age

Exclusion Criteria:

* Another chronic disease (which would complicate measurement of patient activation)
* Non-English-speaking
* Cognitive or psychiatric disorder that the physician or study therapists believe would impair study participation.
Oxytocin Versus, Sublingual Misoprostol in the Secondary Prevention of Postpartum Hemorrhage After Vaginal Delivery

Researchers sought to see how oxytocin versus, sublingual misoprostol affected estimated and measured blood loss during vaginal delivery in women who had blood loss \>300 ml .

The greatest cause of maternal mortality globally is postpartum hemorrhage (PPH), which is defined as a blood loss of 500 mL or more after birth. All women giving birth should be given a preventive uterotonic drug, according to the World Health Organization (WHO).

Despite the use of a uterotonic drug as a preventative measure, PPH remains a frequent complication, accounting for one-quarter of all maternal fatalities worldwide. When prophylaxis fails and PPH develops, it is advised that uterotonic medicines be used as first-line therapy. However, it's unclear whether the uterotonic drug is better for treating PPH as first-line therapy.

Eligibility Criteria:
Inclusion Criteria:

* vaginal birth in women who had blood loss \>300 ml

Exclusion Criteria:

* \<37 weeks of pregnancy,
* genital tract injuries,
* coagulation deficit,
* hypertension, preeclampsia,
* cardiac, renal, or hepatic disease,
* epilepsy,
A Study of Peripheral Blood Progenitor Cells Mobilisation (PBPC) With VTP195183 Plus Granulocyte-Colony Stimulating Factor (G-CSF) Compared to Mobilisation With G-CSF Alone

Hematopoietic stem cells (HSC) are used to support the administration of high dose chemotherapy for a range of human cancers. For a safe HSC transplantation, a minimum of 5 million HSC per kilogram are required. HSC are collected from the bone marrow by using drugs such as G-CSF (filgrastim) which 'mobilize' them from the bone marrow into the bloodstream. HSC are collected from the bloodstream using an apheresis machine. Between 5 and 60% of patients fail to mobilize the minimum HSC dose required for safe transplantation, and this trial is investigating a way to enhance mobilization to overcome this problem. This trial aims to determine if a new vitamin A derivative is capable of enhancing HSC mobilization when used in conjunction with G-CSF. Patients will undergo two mobilization procedures. They will be given G-CSF alone, or a combination of the study drug plus G-CSF, and their stem cells will be collected. A comparison group of patients will be given G-CSF alone for both mobilizations. Stem cells collected from patients in this trial will be frozen and stored until they are required for transplantation into that patient. At that time, patients will be monitored for how well they recover from their high dose chemotherapy and HSC transplantation.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18-70
2. Histologically proven multiple myeloma or lymphoma
3. Intent of treating physician to proceed to high dose therapy and autologous transplantation
4. Not currently receiving thalidomide (within 1 week of commencing VTP195813 or G-CSF), cytotoxic agents or high dose prednisolone or Dexamethasone (at doses greater than 15 mg prednisolone or equivalent per day)
5. Multiple myeloma patients must be taking regular bisphosphonate therapy
6. Absolute neutrophil count between 1.5 and 10 x 109/L
7. ECOG performance status ? 2
8. Life expectancy of at least 2 months
9. Written informed consent signed by patient or legally authorized representative

Exclusion Criteria:

1. Active infection or a fever \> 38.2 degrees C (fever due to B symptoms in lymphoma patients will not exclude a patient)
2. Use within the previous 30 days of other vitamin A preparations within the last 30 days (including oral vitamin supplements, oral retinoids for acne or other skin disorders, bexarotene, or topical vitamin A preparations)
3. Pregnancy or breast feeding. Women of child-bearing potential, admitted to the trial must take adequate measures to prevent conception (at least two different forms of contraception during the study and for at least one month after completion of study drugs) and are to undergo a pregnancy test
4. Significant non-malignant disease including HIV infection, uncontrolled hypertension (diastolic blood pressures \> 115 mmHg), unstable angina
5. Known allergy to E.coli-derived products
6. Current treatment with tetracycline antibiotics
Study of a Multimodality Pain Management Protocol on Postoperative Neurosurgical Pain

High levels of postoperative pain are associated with an increased risk of lung and heart complications, are the most common reason for delayed discharge or for unexpected hospital admission after ambulatory surgery, and are responsible for prolonged recovery after inpatient surgery. Furthermore both neuropathic pain and post surgical pain inhibit weight gain and may have an impact on the patient's nutrition post operatively. The purpose of this study is to evaluate the effectiveness of a multimodality pain management protocol on postoperative neurosurgical pain.

Despite the long-standing recognition of postoperative pain as both prevalent and undertreated, 20% to 30% of all surgical patients continue to experience moderate to severe postoperative pain. High levels of postoperative pain are associated with an increased risk of pulmonary and cardiovascular complications, are the most common reason for delayed discharge or for unexpected hospital admission after ambulatory surgery, and are responsible for prolonged convalescence after inpatient surgery. Furthermore both neuropathic pain and post surgical pain inhibit weight gain and may have an impact on the patient's nutrition post operatively. Finally, high levels of postoperative pain have also been associated with an increased risk of chronic pain. Therefore, the aggressive treatment of postoperative pain may be particularly important in influencing patient outcomes, inadvertent readmissions, and propensity for developing chronic pain.

Eligibility Criteria:
Inclusion Criteria:

* Postoperative neurosurgical patient treated at the University of Florida
* Primary language is English

Exclusion Criteria:

* Younger than 18 or older than 100 years of age
* Patients who are pregnant, wards of the state, prisoners, and patients who lack the ability to communicate their pain level
Randomized Controlled Trial of a Single-session Mechanism-focused Intervention for Suicidal Thoughts and Behaviors

Across multiple models of suicide risk, hopelessness and perceptions of social relatedness (i.e., lack of social connection/thwarted belongingness, perceived burdensomeness) have emerged as candidate mechanisms that maintain STBs. Although these mechanisms have garnered strong empirical support in predicting STBs, there has been virtually no integration with interventions aimed for individuals at acute risk for suicide. Thus, the overarching goal of the present proposal is to evaluate a mechanism-focused intervention that explicitly targets two core mechanisms implicated in the maintenance of STBs: hopelessness and negative perceptions of social relatedness. Given that the period immediately following hospital discharge presents the highest risk for suicide attempts and up to 70% of patients admitted for a suicide attempt do not attend their first outpatient appointment, the intervention will be evaluated on an inpatient unit. Additionally, most of the extant interventions for STBs are administered across multiple sessions (i.e., 4 sessions and up to one year); however treatments of this length are unlikely to be feasible in acute care settings. Fortunately, very brief suicide prevention interventions, are effective in reducing future suicide attempts and increasing the likelihood of attending follow-up treatments. Additionally, single-session interventions (not suicide specific) have been shown to reduce hopelessness immediately and at a one-month follow-up.

The present study is an RCT comparing a novel Single Session Mechanism Focused Intervention (SSMFI) for STBs to treatment-as-usual (TAU) on a psychiatric inpatient unit for patients admitted for suicidal ideation or attempt. The engagement of the putative processes (hopelessness and negative perceptions of social relatedness) that maintain STBs will be assessed, along with the feasibility and acceptability of SSMFI for STBs on an inpatient psychiatric unit.


Eligibility Criteria:
Inclusion Criteria:

* admitted for care to the Adult Inpatient Unit at Good Samaritan Hospital
* endorse suicidal ideation and/or a recent suicide attempt (i.e., "a potentially self-injurious act committed with at least some wish to die") upon intake to the unit
* 18 years of age; (4) English speaking
* able to provide two methods for follow-up contact (i.e., phone number, email address) in order to complete study follow-up assessment.

Exclusion Criteria:

* current manic episode
* acutely psychotic
* actively detoxicating from substances
* the inability to comprehend the intervention
Culturally Enhancing a Motivational Interviewing Intervention For Latinx Adolescents

The purpose of this study is to compare two versions of an intervention focused on teaching 10-14-year-old Latina/o adolescent's skills that will decrease the likelihood that they will use tobacco, alcohol, and other drugs. We are also interested in determining how cultural context is related to substance use and whether additional information about other tobacco products should be added to the GMIT intervention.

All adolescents will receive the Group Motivational Interviewing for Teens (GMIT) intervention. GMIT is an evidence-based group intervention that has been shown to prevent substance use among adolescents. In this project, GMIT will be delivered virtually in a group setting to multiple Latina/o adolescents. In addition, some parents will virtually participate in a parent-only support group; the other parents will not participate in any group.

In this study, participants will be randomly assigned (like flipping a coin) to receive one of two versions of an alcohol, drug, and tobacco program. As part of the program teen participants will virtually attend six 30-min intervention sessions with other teens. Parents may also participate in virtual group sessions. Participants will be asked on three separate occasions (before, immediately after, and 3 months after the sessions) to complete forms (phone/online) that ask questions about teens behavior at home, school, and in the community.

Eligibility Criteria:
Inclusion Criteria:

* Adolescents must be between 10 and 16 years of age - parents can be any age
* Parent and adolescent must consent/assent to participate as dyad
* Self-identify as Latina/o or Hispanic

Exclusion Criteria:

* Under the age of 10 or over the age of 16
* Parent or adolescent refuses
* Identify as non-Latina/o or non-Hispanic
5FU and Octreotide Long-acting Release (LAR) for Neuroendocrine Tumors

Well differentiated neuroendocrine carcinomas have low proliferative activity and conventional chemotherapy is not recommended. Metronomic chemotherapy, i.e. the frequent administration of cytotoxic drugs at low doses, has demonstrated antiangiogenetic properties. Since well differentiated NE carcinomas are highly vascular, there is a rationale for testing metronomic chemotherapy in this clinical setting.

A phase II study was designed to test the activity of protracted 5-fluorouracil (5FU) infusion plus long-acting release (LAR) octreotide for patients with neuroendocrine carcinoma.

Metastatic or locally advanced well differentiated neuroendocrine carcinoma were treated with 5Fluorouracil protracted intravenous infusion (200 mg/m2 daily) plus Octreotide LAR (20 mg monthly).

Primary Endpoint: the response to treatment, evaluated according to the RECIST criteria.

Secondary Endpoints:

* toxicity, graded according to the NCI-CTG criteria;
* symptomatic response: evaluated according to the changes in both the frequency and intensity of symptoms;
* biochemical response: evaluated considering the changes in the tumor marker levels (circulating Chromogranin A);
* time to progression and survival: were measured from the date of treatment start to the date of progression and the date of last follow-up or death, respectively.

Eligibility Criteria:
Inclusion Criteria:

* histological diagnosis of well-differentiated neuroendocrine carcinoma according to the World Health Organization (WHO) classification;
* locally advanced or metastatic disease not amenable to surgery with radical intent;
* at least one measurable target lesion;
* radiological documentation of progressive disease;
* ECOG performance status grade \<=2;
* life expectancy \>12 weeks;
* adequate bone marrow reserve;
* adequate hepatic and renal function;
* ability to comply with the protocol procedures (including geographic accessibility);
* written informed consent.

Exclusion Criteria:

* non-malignant systemic disease or conditions that precluded patients from receiving the study therapy;
* second primary malignancies and previous systemic antineoplastic treatment including somatostatin analogues;
* history of prior malignancy, excepted for cured non-melanoma skin cancer, and cured in situ cervical carcinoma.
Comparison of Crinone 8% Intravaginal Gel and IM Progesterone Supplementation for In Vitro Fertilization (IVF)

The goal of this research study is to compare the pregnancy rates for two different types of progesterone supplementation after in-vitro fertilization (IVF).

The aim is to test the hypothesis that the pregnancy rates of women under age 40 undergoing an in vitro fertilization and embryo transfer (IVF-ET) cycle are not different with respect to the administration of progesterone (Crinone 8%, intravaginal gel versus intramuscular progesterone).

Eligibility Criteria:
Inclusion Criteria:

* Women of reproductive age (21-39) with infertility who are appropriate candidates for IVF/ET and have an FSH \< 15 mIU/ml
* Women 21 to 39 years of age who have been assigned to stimulation of 2 to 8 amps of Luteal Lupron/FSH or Luteal Lupron FSH/HMG.

Exclusion Criteria:

* Women who have had more than 3 previous IVF/ET cycles
GERAP's Epidemiological Survey on Perioperative Hypersensitivity Reactions

Perioperative hypersensitivity reactions are still associated with significant morbidity and mortality despite early recognition and use of epinephrine. The epidemiology of these reactions evolves over time and changes with clinical practice. The main objective is to study the epidemiology of these reactions over a 10-year period, including patient phenotype, reaction phenotype and outcome of the allergic work-up.


Eligibility Criteria:
Inclusion Criteria:

* Minor and major subject
* Subject having experienced a perioperative hypersensitivity reaction between January the 1st 2017 and December the 31st 2027.
* Referred for an allegro-anesthetic workup
* Subject not having expressed his opposition, after information, to the reuse of his data for the purposes of this research.

Exclusion Criteria:

* Subject having expressed opposition to participating in the study
* Inability to provide the subject with research information
* Subject under guardianship or guardianship
* Subject under safeguard of justice