cyrilzakka/clinical-trials huggingface dataset:
Pilot Behavioral Support Intervention After Bariatric Surgery

Prospective, randomized pilot trial to evaluate a comprehensive postoperative behavioral support intervention using a 4-month bi-weekly program in 40 bariatric surgery patients (all surgical procedure types) from the Geisinger Health System Center for Nutrition and Weight Management compared to 40 usual care patients.

Bariatric surgery patients may experience significant psychosocial changes after surgery, but little psychological support is available beyond support groups postoperatively. Psychosocial changes after surgery, including mood fluctuations, interpersonal issues and substance use, have the potential to lower quality of life and interfere with adherence to the postoperative diet and lifestyle, diminishing weight loss outcomes.

This prospective randomized pilot trial will evaluate the effect of a postoperative support program targeting quality of life, psychosocial functioning and adherence to behavior change in Geisinger Health System (GHS) bariatric surgery patients.

In this study there will be two arms. The intervention arm will include forty bariatric surgery patients (all procedure types) from the GHS Center for Nutrition and Weight Management (CNWM) who will participate in a four month bi-weekly postoperative behavioral support program to address psychosocial changes after surgery, strategies for postoperative diet and adherence and preventing weight regain. The control arm will include 40 usual care (UC) patients from the same center that completed bariatric surgery within one year.

Both groups will complete two sets of surveys. The first set will be administered at study initiation. The second set will be administered upon completion of the 8 sessions for the intervention group. The control group will also complete surveys during this same timeframe (approximately 4-6 months after baseline survey completion).

Upon study completion, control group members will be afforded an opportunity to participate in the same postoperative behavioral support program offered to the intervention group.

The primary endpoint of this study will be quality of life with secondary endpoints including differences in psychosocial functioning (mood, eating behaviors) and adherence (diet, physical activity, appointments) as well as patient satisfaction, treatment feasibility and attrition.

Eligibility Criteria:
Inclusion Criteria:

* BMI\>35 kg/m2 at time of surgery
* Primary bariatric surgery completion \< 1 year
* Understanding of informed consent

Exclusion Criteria:

* Pregnancy
* Revision of bariatric surgery
* Significant cognitive impairment that prevents informed consent
Starling/CRRT Observational Study

Hemodynamic optimization of critically ill patients is a goal for clinicians in order to afford the patient the best possible outcomes. Being able to precisely and rapidly determine patient fluid responsiveness provides the bedside physician and nursing staff the information needed to make critical decisions in regard to the patient's fluid status and management of additional fluids and medications.

As fluid management and cardiac output determination are linked to better decision-making and improved outcomes in ICU, the use of a dynamic assessment of fluid responsiveness becomes a key tool for patient management.

This study is designed to collect treatment and outcome data on patients that have undergone hemodynamic monitoring during CRRT therapy.


Eligibility Criteria:
Inclusion Criteria:

1. ≥18 to 95 years of age.
2. Patient has undergone hemodynamic monitoring with the Starling monitor during a CRRT treatment.
3. Hemodynamic monitoring was completed no earlier than 2018

Exclusion Criteria:

1. Patients did not have an arterial line in place during CRRT treatment
2. Patients on extracorporeal membrane oxygenation (ECMO) or left ventricular assist device (LVAD)
3. Patients with end-stage kidney disease on chronic dialysis
4. Hemodynamic monitoring with Starling did not occur during CRRT treatment
5. Data from Starling, CRRT machine, or arterial line cannot be retrieved
Alopecia Areata Registry

Alopecia areata is the loss of hair in patches that can proceed to loss of all hair (alopecia totalis or universalis). The purpose of the registry is to collect patient information and blood samples from people with alopecia areata.

Alopecia areata is a condition in which hair is lost either from part of the scalp, all of the scalp, or the entire body, and it affects 1% to 2% of the population. It is thought to be an autoimmune disease and in some cases the disease is hereditary. The Alopecia Areata Registry will collect information and blood samples from clinically well-characterized patients with these three forms of alopecia areata: alopecia partialis (patchy loss of the scalp hair), alopecia totalis (total loss of all scalp hair), and alopecia universalis (complete loss of all hair everywhere on the body). This will be a collection of patients in multi-generational families, twins, single patients with patchy, persistent transient alopecia areata or long-standing alopecia totalis/universalis and with controls (persons unaffected and not related to alopecia patients). Information from these patients will be used to search the human genome for disease-associated loci and/or genes. Researchers interested in doing pathophysiology or treatment studies of this disease will also be able to contact patients having the appropriate form of the disease for the studies in question.

Patients who have been diagnosed with alopecia areata by a dermatologist will be eligible for the registry. Patients will fill out an information form online (alopeciaareataregistry.org). Patients who have a family history or specific types of alopecia will be invited to participate in a more detailed questionnaire and physical exam and have blood samples drawn.

Eligibility Criteria:
Inclusion Criteria

* Diagnosed with alopecia areata by a dermatologist
* United States resident

Accepts Health Volunteers: Non blood-related individuals who are unaffected with alopecia areata and do not live in the same household with alopecia areata patient.
Effect of Propolis Administration for Dysmenorrhea in Endometriosis Patient With Levonorgestrel Implant Therapy

The goal of this clinical trial is to investigate the effect of propolis administration on dysmenorrhea in endometriosis patient. the main questions it aims to answer are:

* Does the propolis administration reduce symptoms of dysmenorrhea in endometriosis?
* Does the propolis administration reduce the amount of oxidative stress biomarkers in endometriosis?
* Does the propolis administration reduce the amount of Inflammatory biomarkers in endometriosis?

Participants will be given an intervention in the form of propolis at a dose of 1 drop per 10 kilogram of body weight per administration, twice a day. there will be a control group that will be given an intervention in the form of a placebo containing 70% caramel alcohol dye solution.


Eligibility Criteria:
Inclusion Criteria:

* Women aged 20-49 years and already menstruating with complaints of menstrual pain referred to the obstetrics and gynecology polyclinic for LNG implant placement
* Willing to have LNG implant installed after receiving explanation about implants
* Not receiving hormonal treatment for endometriosis within the last 3 months
* Can receive drops (propolis) during the study

Exclusion Criteria:

* Impaired liver function, degenerative diseases (DM, hypertension and cardiovascular disease), benign tumors, cancer
* Pregnancy and breastfeeding
* Hypersensitivity to levonogestrel
* Thromboembolic disease
* Experiencing bleeding for unknown reasons
* History of allergies to honey and its processed products
* Currently taking supplements/drugs that are not included in the standard management of endometriosis patients at RSCM
* Have consumed propolis before
* Received hormonal treatment within the last 3 months
A Comparative Study of AI Methods for Fetal Diagnostic Accuracy in Ultrasound

This study serves as a supplemental investigation to the randomized controlled SCAN-AID study (NCT0632187). This study will evaluate and compare the fetal growth estimation outcomes of AI-supported groups, expert sonographers, and control groups using a secondary AI predictive model.

The goal of this study is to compare the effects of two distinct AI methods on fetal ultrasound diagnostic accuracy. It serves as a supplementary investigation to the SCAN-AID study (NCT NCT06232187). This study aims will compare the diagnostic accuracy of two types of AI methods.

From the SCAN-AID study ultrasound novices were randomized into one of three groups with different levels of AI support: control group, AI feedback group 1 where the participants are presented with basic black box AI feedback, and AI feedback group 2 where the participants are presented with a more detailed explainable AI feedback. All the participants are tasked to perform an ultrasound fetal weight estimation (EFW) on pregnant women at gestational age 30-37. The outcomes were than compared to the expert sonographers measurements.

In this study an operator independent AI method that predicts the fetal weight is used on the SCAN-AID ultrasound examinations. .

Eligibility Criteria:
Pregnant women:

Inclusion Criteria:

* Singelton pregnant.
* Gestational age: 30-38 weeks
* Maternal age \< 40 years

Exclusion Criteria:

* Oligo hydramnion
* Severe fetal anomaly e.g. fetal heart anomaly, omphalocele etc.
* Severe fetal macrosomia or growth restriction.
DART I - A Phase IV Study of 3 Antiretroviral Medicines in Combination, in HIV Patients Who Have Not Been Previously Treated With Antiretroviral Therapy

The purpose of this study is to evaluate whether a therapy with an all once daily regimen of efavirenz (EFV), didanosine (ddI)-EC and lamivudine (3TC) leads to improved outcomes, as measured by viral load, CD4 counts, adherence, safety, and tolerability.


Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years of age or older infected with HIV and weigh at least 40 kg.
* Plasma HIV RNA viral load of 1000 copies/mL or greater and CD4 count of 100 cells/mL or greater
* Be willing to use two forms of contraception throughout study
* No previous exposure to antiretroviral (ARV) drugs

Exclusion Criteria:

* Pregnancy or breastfeeding
* Physical or psychiatric disability
* Proven or suspected acute hepatitis within 30 days prior to study entry
* Active AIDS-defining opportunistic infection or disease
* History of acute or chronic pancreatitis
Evaluation of the Comprehensive Primary Care Initiative

This study assesses the effects of the Centers for Medicare and Medicaid Services' Comprehensive Primary Care (CPC) initiative on physician practices, practice staff, Medicare and Medicaid costs and service utilization, quality of care, and patient outcomes. CPC provides financial resources, timely feedback on key practice outcomes, and a learning network to support practice transformation to improve quality of care and lower costs.

CMS selected 7 regions (states or substate areas) to include in this study, based on commitment of other (ie, nonMedicare) payers in the area to provide financial resources to participating practices to support practice transformation to improve quality of care, reduce costs, and improve population health. 497 practices were selected from roughly 1000 applicants in the 7 regions to participate in the study. CMS pays participating practices a per member per month care management fee for each Medicare patient attributed to the practice. The practices also receive quarterly feedback on trends in their Medicare patients' use of hospital and emergency room services, Medicare expenditures, and patient outcomes from periodic surveys. Practices are expected to improve patient outcomes and lower Medicare costs per patient by using the additional resources to improve: risk-stratified care management, access and continuity of care, planned chronic and preventive care, patient and caregiver engagement, and coordination across the medical neighborhood. To remain in the study, practices must meet annual milestones for meaningful use of electronic health records and other practice features. The intervention period, which began in Fall 2012, will continue for 4 years.

Eligibility Criteria:
Inclusion Criteria:

* Medicare beneficiary attributed to CPC practice or to a matched comparison practice. Patients are attributed to the practice from which they received the most E\&M visits during the 2-year period examined.

Exclusion Criteria:

* Beneficiaries enrolled in a managed care plan.
Dose-escalation Trial of Preoperative Radiotherapy and Concurrent Chemotherapy in Locally Advanced Rectal Cancer

The aim of this study is to evaluate the increase of radiation dose administered in patients diagnosed with locally advanced rectal cancer in terms of ypRC with tolerable toxicity, using IMRT (concomitant boost technique).

The hypothesis that arises is an improvement in the proportion of pathological complete responses, resulting therapeutic gain, as a result of a higher dose of radiation delivered to the tumor volume without incurring a higher gastrointestinal toxicity to the patient or surgical complications later, thanks to the use of intensity modulated radiotherapy (concomitant boost technique) that allows us to significantly reduce the administered dose organs at risk.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically proven diagnosis of adenocarcinoma of the rectum
* Clinically determined to be stage T3 or T4,N0-N2, and M0 -staged by MRI or transrectal ultrasound of the rectum
* Patients who are medically operable and who have resectable adenocarcinoma of the rectum at least \<11cm from the anal verge
* Adequate liver/renal and haematological function.
* Eastern Cooperative Oncology Group (ECOG) performance 0-2
* Age ≥ 18 years
* Full blood count obtained within 2 weeks prior to registration on study, with adequate bone marrow function defined as follows:

  * Absolute neutrophil count (ANC) ≥ 1,800 cells/mm3
  * Platelets ≥ 100,000 cells/mm3
  * Haemoglobin ≥ 8.0 g/dl
  * Serum creatinine within normal institutional limits
  * Bilirubin within normal institutional limits
  * AST and ALT \< 2.5 x the IULN
* Patient must sign study specific informed consent prior to study entry

Exclusion Criteria:

* Prior systemic chemotherapy for colorectal cancer; note that prior chemotherapy for a different cancer is allowable.
* Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
* Any evidence of distant metastases (M1)
* A synchronous primary colon carcinoma
Bypass PACU in Knee and Hip Arthroplasty

A Quality Study in the use of Post-Anaesthesia Care Unit(PACU) in Hip and Knee Arthroplasty, and the ability to bypass this unit.

The investigators wish to investigate the amount of patients who is required to be secondary admitted to the PACU, after primary discharge from the operating room to the surgical ward, thereby bypassing the PACU.

The investigators wish to investigate the use of our standardized regimen for discharging patients directly to the surgical ward, thereby bypassing the PACU. The anaesthesiology dept. have a local standard operating procedure for doing this, and the patients will be treated according to this.

This means that Patients will be discharged directly to the surgical ward if the following criteria are met:

* American Society of Anaesthesiologist-score (ASA-score) \< 3
* Anaesthesia and surgery without any complications, vital signs normal during the whole procedure and not demanding oxygen supplement on the end of the procedure.
* Bloodloss \< 500 ml.
* Postoperative evaluation, Early Warning Score, and postoperative score documented in Electronic Patient journal(EPJ).

The patients will upon arrival at the surgery start a registration containing preoperative data(baseline morbidity, sex, height, weight, type of anaesthesia and surgery), perioperative data containing surgery and anaesthesia data, and postoperative discharge-score(local operating procedure).

After discharge to either the surgical ward or the PACU, the patient will be observed closely the first 2 hours while recording every intervention made by the nurse staff.

After the initial 2 hours the recording goes on the next 24 hours recording every event and intervention which lead to a doctor consult, by telephone or physically examining the patient.

Also, the investigators wish to evaluate the use of the discharge Score(Danish Society of Anaesthesia and Intensive care Medicine(DASAIM)-SCORE), which is used as the discharge score after surgery in other hospitals in Denmark, and the investigators therefore record this after surgery, and every 30 minutes after the surgery for the first 2 hours.

Eligibility Criteria:
Inclusion Criteria:

* Planned elective unilateral primary Hip- og Knee-Arthroplasty and unicompartmental Knee-Arthroplasty.
* Above 18 years.

Exclusion Criteria:

* none
The Effect of Computerized Cognitive Training on Mood and Thinking Style Amongst Patients in Inpatient Settings

The purpose of this randomized controlled trial is to establish feasibility and provide initial estimates of efficacy of two computerized cognitive training procedures (a form of Positive Mental Imagery Training, PMIT, and a form of Cognitive Control Training, CCT) delivered as adjuncts to treatment as usual (TAU) in inpatient mental health treatment settings.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or above
* Sufficient German language skills
* Receiving treatment in a participating inpatient clinic during the timeframe of the study (i.e. they must be able to complete the training entirely within their admission).

Exclusion Criteria:

* Existence of a condition or circumstances that would interfere with completion of the study procedures (e.g. severe visual impairment, neurological problem, acute psychosis or substance withdrawal symptoms)
Remote Ischemic Conditioning in Adult Moyamoya Disease Patients

Remote ischemic conditioning (RIC) is a non-invasive therapeutic approach for protecting organs or tissue against the detrimental effects of acute ischemia-reperfusion injury. Many protective factors produced by the stimulus of RIC could protect remote target organs and tissues through inhibiting oxidation and inflammation. The phenomenon of this protect effect was first found in myocardium ischemia-reperfusion injury and then RIC was used in children cardiac surgery to provide myocardial protection during operation. Then RIC was gradually applied to brain protection and a series of clinical researches have confirmed that it could improve the cerebral perfusion status, increase cerebral tolerance to ischemic injury, reduce perihematomal edema and promote clearance. Recently, a randomized controlled study reported that daily RIC could improve cerebral perfusion and slow arterial progression of adult MMD. Meanwhile, a single-arm open-label study also indicated that RIC was a promising noninvasive method for ischemic MMD control by relieving symptoms and reducing stroke recurrence. In addition, the effects of RIC on reducing neurological complications in MMD patients treated with revascularization surgery has also been reported. However, the mechanism of RIC in reducing peri-operative complications for MMD patients is still unknown. Thus, we conducted a randomized controlled study to explore the safety and efficacy of RIC in adult MMD patients undergoing revascularization therapy


Eligibility Criteria:
Inclusion Criteria:

1. Patients aged from 18 to 65 years old;
2. Subjects all performed digital subtraction angiography (DSA) and diagnosed with MMD accroding to the criteria recommended by the Research Committee on MMD (Spontaneous Occlusion of the Circle of Wills) of the Ministry of Health and Welfare of Japan in 201211.
3. Modified Rankin Scale (mRS) score\<4;
4. Informed consent obtained from the patient or legally authorized representative.

Exclusion Criteria:

1. Subjects suffered from acute ischemic or hemorrhagic stroke within 3 months;
2. Severe hepatic or renal dysfunction;
3. Severe cardiac disease;
4. Severe hemostatic disorder or severe coagulation dysfunction;
5. Serious, advanced, or terminal illnesses with anticipated life expectancy of less than one year;
6. Patients with moyamoya syndrome caused by autoimmune disease, Down syndrome, neurofibromatosis, leptospiral infection, or previous skull-base radiation therapy;
Screening Day Latin America

This is a survey which will be performed on a specific day (the "Screening Day") in Latin American ICUs.

In eligible patients who receive enteral or parenteral nutrition a retrospective calculation of the "caloric deficit" will be performed. The caloric deficit is the difference between energy target of each patient and actually administered calories.

The Screening Day Latin America is a non-interventional, cross-sectional and retrospective study. The study focusses on patients receiving enteral (tube feeding, EN) and/or parenteral nutrition (PN).

All patients hospitalized on the defined Screening Day in participating ICUs will be checked for eligibility. In eligible patients the patient charts will be reviewed and the following parameters will be documented:

* Caloric deficit (daily target energy - actually administered energy via EN and PN). The caloric deficit will be calculated for 1 to up to 5 days before the Screening Day. The analysis will be done for each day and for the complete documentation period up to 5 days. Primary focus will be the caloric deficit on Day -1.
* Nutritional status of the patient based on information from the patient charts. For this, three tools will be applied independently: Subjective Global Assessment (SGA), NUTRIC Score, ESPEN diagnosis of malnutrition

The study will be performed in 8 Latin American countries.

Data will be recorded anonymously in an electronic case report form.

The study data of this explorative study will be analyzed using descriptive statistical methods.

Eligibility Criteria:
Inclusion Criteria:

Patients will be included if the following criteria are fulfilled:

* Critically ill adult (≥18 years of age) patients, including critically ill major gastrointestinal surgery patients
* Patient is hospitalized in Intensive Care Unit (ICU) on the Screening Day
* Patients receiving enteral nutrition (EN; tube feeding only) and/or parenteral nutrition (PN) on the Screening Day and the day before the Screening Day
* Initiation of enteral nutrition (EN) and/or parenteral nutrition (PN) during ICU admission and at least one day before the Screening Day

A critically ill patient is defined as a patient with at least one organ failure.

Exclusion Criteria:

The following patients are excluded from the documentation:

* Critically ill burn patients
* Patients on the Intensive Care Unit (ICU) for surveillance without needing enteral nutrition (EN) and/or parenteral nutrition (PN)