cyrilzakka/clinical-trials huggingface dataset:
Stress-Busting Program for Caregivers of Patients With Neruological Diseases

Although family caregivers perform an incredibly valuable service for their relatives and the formal health care system, they do so at a considerable cost to themselves both emotionally and physically. Effective stress management techniques can: 1) help to decrease the caregivers' feelings of burden and stress; 2) improve the emotional and physical health of caregivers; and 3) empower caregivers to gain control of their lives.

The overall goal of this randomized clinical trial is to determine the effectiveness of a stress-busting program (SBP) for caregivers of patients with chronic neurological diseases including stroke, Alzheimer's disease, multiple sclerosis, and Parkinson's disease. Specific research objectives include: 1) Prospectively determine the effects of a SBP compared to a standard support group (SSG) on quality of life and immune response in caregivers of patients with chronic neurological diseases. Subjects will be tested at baseline, at completion of 4 and 8 weeks of SBP or SSG, and at 2- and 4-month follow up sessions. 2) Determine subjects' relaxation response as well as their response to acute laboratory stressors using bioinstrumentation. Muscle tension, electrodermal response, skin temperature, blood volume pulse, and heart rate will be measured. Subjects will be tested at baseline, at completion of 4 and 8 weeks of a SBP or SSG, and at 2- and 4-month follow up sessions. 3) Compare the effectiveness of SBP or SSG for adult children caregivers as compared to spousal caregivers based on quality of life measurements, immune parameters, and relaxation response. The proposed multimodal SBP will focus on a variety of approaches based on cognitive behavioral and relaxation response theories. SBP will consist of a 8-week program with 1�-hour sessions per week. The setting will be an educational support group with topics related to stress, stress and challenges of caregiving, depression, coping strategies, positive thinking, and taking time for oneself. In addition, subjects will be taught simple relaxation strategies that they can practice at home. Outcomes will be measured using psychosocial instruments as well as state-of-the science technology including bioinstrumentation and immune parameters to measure biological responses. Follow up testing will be done 2 and 4 months after the end of the SBP or SSG to determine the long-term effectiveness of the intervention.

Eligibility Criteria:
Inclusion Criteria:

The primary caregiver of an individual with a neurological disease. Able to read and converse in English.

Exclusion Criteria:

Presently participating in an ongoing support group related to the neruological disease.
Intrusive Reexperiencing: The Role of Working Memory Capacity and Thought Suppression

This study aims at identifying risk factors for the development of intrusive reexperiencing symptoms. In particular, the investigators examine the influence of working memory capacity and thought suppression on the occurrence of unpleasant memories of a negative experience.

Hypothesis: People with high working memory capacities (HWMC) are able to successfully suppress memories of an unpleasant experience (presentation of a distressing movie). In contrast, in people with low working memory capacities (LWMC), attempts to suppress memories of an unpleasant experience inadvertently lead to an increase of these memories.

Study phase one: Assessment of working memory capacity in 200 healthy participants by means of a computerized task. Selection of 50 participants with HWMC and of 50 participants with LWMC who participate in study phase two.

Study phase two: Presentation of a distressing movie and subsequent assessment of memories of the movie during several days in the daily life of participants. Comparison of 4 groups regarding the frequency of instructions in daily life:(group 1: HWMC participants who are instructed to suppress thoughts of the movie, group 2: LWMC participants who are instructed to suppress thoughts of the movie, group 3: HWMC participants who are instructed to allow the occurence of thoughts of the movie, group 4: LWMC participants who are instructed to allow the occurence of thoughts of the movie)


Eligibility Criteria:
Inclusion Criteria:

* Older than 17 years

Exclusion Criteria:

* Insufficient knowledge of the German language, for the distressing movie arm of the study: Elevated levels of depression or posttraumatic stress symptoms prior to viewing of the distressing movie
Predictive Factors of Regain in Bariatric Patients Without Outpatients Care Regular.

The bariatric surgery is recommended for treatment of patients with severe obesity, resulting in greater weight loss and improvement of cardiovascular and metabolic comorbidities. However, weight regain is observed in patients after surgery, leading to health adverse outcomes. The purpose of this study is to identify the rate of weight regain and predictive factors of regain in bariatric patients without outpatients care regular.

Post-bariatric patients without care by health professional will be recruited. Patients will be divided, initially, in two groups by time after surgical procedure, as follows: Group 1≤ (G1≤) - patients that performed bariatric surgery for ≤ 1 year and Group 1\> (G1\>) - patients that performed bariatric surgery for \> 1 year. Patients will be seen in a medical set for the first time at the Policlínica Piquet Carneiro (PPC) for outpatients care, which will consist of anamnesis and physical examination, obtaining demographic, socioeconomic data, medications and clinical history. The TxR will be calculated by \[TxR = (current weight - minimum weight reported) x 100 / (weight preoperatively reported - minimum weight related)\] and information on predictive variables for weight regain will be obtained by Alcohol Use Disorders Identification Test (AUDIT), Beck Depression Inventory (BDI), International Physical Activity Questionnaire (IPAQ), ActiGraph GT3X + accelerometer, 36-Item Short-Form Health Survey (SF-36), Eating Disorder Examination-Questionnaire (EDE-Q) and Repetitive eating questionnaire (REP(EAT) Q). The inclusion period of new patients in the PPC Obesity Clinic will be one year.

Eligibility Criteria:
Inclusion Criteria:

- Bariatric patients without regular medical follow-up

Exclusion Criteria:

* Pregnancy
* Bariatric patients under one year of surgery
Precision Alemtuzumab Dosing for Allogeneic Hematopoietic Cell Transplantation

Alemtuzumab is an antibody that reduces the strength of the immune system that is given in preparation for allogeneic hematopoietic cell transplant (HCT). In this research study the investigators want to find out if they can adjust the dose of alemtuzumab used as part of allogeneic HCT to target the level of Day 0 (the planned day of graft infusion) to an optimal therapeutic window of 0.15-0.9 ug/mL.

Alemtuzumab levels at Day 0 can affect:

* the chances of developing acute graft versus host disease (GVHD), which is an immune reaction of the donor cells against your own tissues
* the chances of developing mixed chimerism, which is having a mixture of your own cells and donor cells after HCT, and
* recovery of your immune system following transplant.

High levels of alemtuzumab are associated with more mixed chimerism and slower immune recovery, while low levels are associated with more acute GVHD. The investigators have developed a plan to adjust the alemtuzumab dose for patients to target Day 0 levels to fall within an ideal effective range of 0.15-0.9 ug/mL. This range may minimize the risks of these complications. The investigators are conducting this study to determine if the current plan for alemtuzumab dosing will be successful in the majority of patients and evaluate the impact on the clinical outcomes of acute GVHD, mixed chimerism, and immune recovery.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are undergoing allogeneic HCT at CCHMC with an alemtuzumab-containing preparative regimen for treatment of a non-malignant disease are eligible.
* Age ≥ 6 weeks to ≤ 30 years (at time of enrollment).
* For the first 7 patients, patients must have a 10/10 HLA matched related or unrelated stem cell donor, or be receiving a CD34+ selected stem cell product. After the first 7 patients, any donor match may be allowed after data review by the BMT clinicians and the PI.

Exclusion Criteria:

* Patients with a history of anaphylaxis to alemtuzumab.
* Patients who have previously received alemtuzumab and have not cleared alemtuzumab prior to the start of the preparative regimen.
* Life expectancy less than 4 weeks.
* Patients receiving dialysis or plasmapheresis at the time of the start of the conditioning regimen.
* Failure to sign informed consent and/or assent, or inability to undergo informed consent process.
* It is not medically advisable to obtain the specimens necessary for this study.
* Not able to tolerate subcutaneous dosing (patients with severe skin conditions).
* Patients with cancer.
* Patients whose clinical condition suggest there may be inability to successfully perform the PK modeling such as, but not limited to, active flaring of hemophagocytic lymphohistiocytosis in which excessive lymphoproliferation may significantly alter the target-mediated clearance of alemtuzumab and prevent observation of non-target mediated clearance which is needed for robust modeling.
* Patients whose pre-alemtuzumab level reveals an interfering substance which prevents accurate measurement of alemtuzumab.
Non-invasive Markers of Esophageal Function in Adults

The investigator proposes to study electrical activity reflective of esophageal motility in adults noninvasively by the use of multichannel electroesophagogram (EESG) and magnetoesophagogram (MESG) recordings.

Dysphagia, or difficulty with swallowing, is a common symptom affecting nearly 9.4 million individuals or 4% of the US population. High resolution esophageal manometry is currently considered the gold standard test for evaluation and diagnosis of esophageal motility disorders, but given that it requires trans-nasal placement in a conscious patient, this test is highly uncomfortable and associated with significant patient dissatisfaction. There are currently no noninvasive tests or markers available to test esophageal function and motility.

In the upper gastrointestinal system, as in the heart, disruption of the electrical syncytium in disease produces measurable dysrhythmia. Recent modifications of the standard electrogastrogram (EGG) that have increased the number of leads to 25 (termed high-resolution EGG) have allowed enhanced spatio-temporal resolution of electric slow wave activity, and newer analytic techniques. Additionally, the magnetogastrogram (MGG) overcomes many of the inherent limitations of the standard EGG. The goal of this proposal is to harness similar technologies applied to the esophagus to develop high-resolution electroesophagogram (EESG) and magnetoesophagogram (MESG) as noninvasive clinical methods to quantify esophageal function and motility disorders, which could guide intervention for a large number of adult patients.

The main aims in this proposal are to develop a mathematical model of esophageal function and characterize phenotypes of esophageal motility disorders using EESG/MESG in healthy controls and esophageal dysmotility patients and determine how EESG/MESG rhythm and pattern abnormalities relate to physiologic function.

Eligibility Criteria:
Inclusion Criteria:

* Adults ≥ 18 years of age who are undergoing HRM for routine standard of care evaluation for esophageal motility.
* Normal control participants (ages ≥ 18 years) who have no known gastrointestinal complications.

Exclusion Criteria:

* Those with claustrophobia who cannot lie still under the SQUID for the length of time required
* Due to interference with signal acquisition, subjects with contraindication to undergoing an MRI scan as noted in the MRI Safety checklist by Vanderbilt University Medical Center (such as with heart pacemakers, metal implants, or metal chips or clips) will not undergo SQUID, but can still be eligible to do cutaneous EESG.
* Morbid obesity (these patients are potentially unable to lie under the current generation of SQUID devices)
* Patients with a history of cardiac arrhythmias or taking anticoagulants will be excluded
Physical Activity in Insurance Medicine: Effects on Patients With Psychiatric Disorders

We will conduct a randomized control trial to investigate whether and to what extent regular and guided group physical activity over 12 weeks (2 sessions à 1 hour/week) improves physical fitness and (physio-)psychological functions (like subjective sleep, mental toughness, perceived stress, self-efficacy, etc.), as well as participation skills and the ability to work, in claimants for a disability pension due to psychiatric disorders, whose ability to work had recently been assessed by means of a psychiatric expert opinion. The control group is designed very similar and implies predominantly sedentary leisure time group activities (e.g. playing board games, doing handicrafts). Measures will be performed at baseline, post-test, and at follow ups three and twelve months after post-test, some variables will additionally be assessed 4-weekly during the intervention. We expect that intervention group participants will report and show, respectively, more improved physical fitness, (physio-)psychological functioning and participations skills, as well as increased ability to work, compared to the control group.


Eligibility Criteria:
Inclusion Criteria:

* Claimants for a disability pension due to a mental disorder, whose ability to work has been recently assessed by means of a psychiatric expert opinion
* Both genders
* 18-55 years old
* Clinical diagnosis of depressive disorder, somatoform disorder, anxiety disorder, personality disorder
* Sufficient competence in understanding, speaking and reading German
* Sufficient cognitive, emotional and social level of functioning to be able to participate in a group
* Physical Activity Readiness Questionnaire without evidence for reduction
* or: Physical activity readiness certificated by the general practitioner
* Informed consent

Exclusion Criteria:

* Comorbidity with a somatic disorder that limits the ability for physical exercises
* Pregnancy
* Ongoing disturbance of the study
Adapted Physical Activity Effect on Aerobic Function and Fatigue at Home in Patients With Breast Cancer Treated in Adjuvant or Neoadjuvant Phase

Physical exercise has been identified as a major item of many chronic diseases and cancer rehabilitation. It contributes to an improvement in the quality of life and to a decrease in the current treatment side effects and mortality. Cancer in association with treatment toxicity and an inactive lifestyle lead to a fall in physical capability and causes problems in daily activities. The physical capacity and the tolerance for exercise fall simultaneously leading to a deconditioning vicious circle which increases physical, psychological and emotional symptoms of fatigue. Therefore, physical activity for health is a valid and relevant way to improve quality of life and to manage cancer patient fatigue. The aim of the study is the assessment of the effects of a physical activity retraining program on aerobic capacity, strength and fatigue, in a breast cancer population treated by adjuvant or néoadjuvant chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* females between 18 and 75 years of age;
* signed written informed consent;
* willing to take part in the trial and to follow the instructions;
* breast tumour, histologically documented;
* patients for whom a 6-treatment course of adjuvant or neoadjuvant chemotherapy (3FEC100 +3 taxanes or 6 FEC) +/- radiotherapy+/- Herceptin has been scheduled;

Exclusion Criteria:

* metastatic cancer;
* disability preventing a proper understanding of the instructions for the trial;
* patients who are subject to a court protection, wardship or guardianship order;
* uncontrolled hypertension;
* family history of sudden death in a first-degree relative;
* unstabilised heart disease;
* current treatment with beta-blockers;
* chronic or acute pulmonary disease associated with dyspnoea upon moderate effort;
* uncontrolled thyroid dysfunction;
* uncontrolled diabetes;
* any other serious conditions that are unstabilised,
* disabling or in which physical exercise is contra-indicated;
* unable to attend for follow-up throughout the duration of the study;
* ventricular ejection fraction (VEF) \< 50%, pregnancy or suckling.
Role of Oxidative Stress in Ovarian Tissue After CO2-pneumoperitoneum Application-induced I/R

Because of cellular changes in response to ischemia and a following period of reperfusion, damages to organs and different tissues occur. There are several ongoing studies to enlighten the pathophysiological processes underlying these damages inflicted by ischemia/reperfusion.

Gases (CO2) with low water content are used in pneumoperitoneum, which is a procedure to inflate the abdominal cavity with an appropriate gas for laparoscopic operations. In the current literature, it was shown that due to a restricted blood flow during the gas insufflation, ischemia develops and with the reperfusion of the organ in deflation period, oxidative stress and inflammation increases, leading to ischemia/reperfusion-related organ and tissue damages.

In the proposed study, biomarkers for ischemia/reperfusion-inflicted damage will be evaluated in a biochemical and histopathological perspective in biopsy samples of ovaries from a young patient group in which hysterectomy and bilateral salpingo-oophorectomy will be performed, laparoscopically.

In the laparoscopic salpingo-oophorectomy, after the induction of anesthesia, an umbilical skin incision was performed. Pneumoperitoneum was established using dry, nonheated CO2 insufflation through a Veress needle. A 10-mm trocar was inserted into the abdominal cavity through the umbilical incision for the laparoscope. Subsequently, three 5-mm ancillary trocars, 2 on the lower abdominal quadrants and 1 on the left upper quadrant, were introduced to the abdominal space under direct optic visualization. IAP was set at 14 mm Hg and maintained with a gas insufflator (Endoflator; Karl Storz Endoscopy, Tuttlingen, Germany)Immediately after the port placement, unilateral oophorectomy was performed, and ovarian biopsies were obtained. The operation continued with ligation and transection of the contralateral utero-ovarian ligament and the bilateral round ligaments. The contralateral infundibulopelvic ligament, which contains the main vascular supply for the contralateral ovary, remained intact. Subsequently, anterior and posterior leaflets of the broad ligament were identified and dissected, and the bladder was placed away from the lower uterine segment. The uterus removed from vaginal way after necessary steps. After desufflation, the cuff closure procedure was performed vaginally. At the end of the closure, pneumoperitoneum was reestablished, the remaining contralateral ovary was removed immediately, and biopsies were obtained for histologic analyses.

Eligibility Criteria:
Inclusion Criteria:

* Transgender Men who wants to remove their uterus and both ovaries.

Exclusion Criteria:

* Known endometriosis
* Hysterectomized patient
* Unacceptance to involve to the trial
* Suspicion of malignancy
Ketofol Versus Propofol in Urgent ERCP for Acute Cholangitis

Endoscopic Retrograde Cholangiopancreatography (ERCP) is a lengthy and uncomfortable procedure that requires adequate sedation. Propofol is the commonly used sedative during ERCP. However, dose dependent cardiac and respiratory depression may occur. Hypotension usually occurs in severe cholangitis which necessitate the use of alternative sedative. The aim is to study the efficacy and safety of ketofol as a sedative during urgent ERCP for severe cholangitis.

This randomized controlled trial was carried out on 96 patients undergoing urgent ERCP for severe cholangitis. Patients were allocated into two groups; group 1: received ketofol and group 2: received propofol. Demographic data, ERCP duration, recovery time, heart rate (HR), mean arterial pressure (MAP), peripheral oxygen saturation, Ramsey Sedation Scale (RSS), pain Numerical Rating Scale (NRS), propofol requirement, adverse events, endoscopists and patients satisfaction were recorded

Eligibility Criteria:
Inclusion Criteria:

* Severe acute cholangitis of either sex
* Aged between 21-70 years
* Undergoing urgent therapeutic ERCP for severe cholangitis with American Society of Anaesthesiologist (ASA) Grade II - III.

Exclusion Criteria:

* Patients who had ASA physical status Grade VI,
* Baseline SpO2 \<90%,
* Patients who had difficulty in communication,
* Patients allergic to the studied medications,
* Morbidly obese patients,
* Patients with chronic obstructive pulmonary disease,
* Complicated airway,
* Pregnant patients.
Stress Analysis of Hip Dysplasia

The main objective of this study is to predict cartilage contact pressures in the hip after periacetabular osteotomy (PAO).

PAO was designed as a joint preserving surgical procedure to compensate for a shallow acetabulum by re-orienting the acetabulum into a position that provides better coverage of the femoral head. Although the overall theory that increasing load bearing area (improving coverage of the femoral head) results in reduced joint stress is intuitive, the complex bony surface may not behave in this manner. It is possible that joint stress may increase when the acetabulum is reoriented into a position that increases load bearing area if post-operative joint congruency is worse than pre-operative.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-40 years
* Patients who have undergone periacetabular osteotomy by Dr. Peters for treatment of hip dysplasia.
* Patients who have previously participated in IRB #10983 "Comparative Stress Analysis of Hip Dysplasia".

Exclusion Criteria:

* Persons with a history of allergies to lidocaine or seafood.
* Children under the age of 18.
* Persons incarcerated, on trial, or parole.
* Women who are pregnant.
* Subjects who do not have high quality pre-operative images available or have not been surgically treated by periacetabular osteotomy.
Transpulmonary Driving Pressure in ARDS COVID19 Patients

A majority (65-85%) of critically ill patients admitted in intensive care units with a confirmed diagnostic of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) developed an acute respiratory distress syndrome (ARDS) according to BERLIN criteria. Gattinoni et al. recently described that the ARDS related to SARS-CoV-2 was not a "Typical" ARDS. Patients affected by this infection present indeed a major hypoxemia, which was surprisingly associated in early phase with a high compliance of respiratory system, more than 50 ml/cm H2O in most cases. The cornerstone of current treatment in case of ARDS is the use of "lung protective" ventilation, including limited tidal volumes (VT), low end-inspiratory plateau pressures while maintaining sufficiently-high positive end-expiratory pressures (PEEP). However, high levels of PEEP in patients may have detrimental effects on hemodynamic status and fluid retention, particularly when the respiratory system compliance is normal. High PEEP may also lead to overdistension and an increase of alveolar dead space. The airway pressures commonly monitored does not reliably reflect the impact of pressures on the lung parenchyma. Elastance of chest wall may indeed largely influence values of airways pressions. In contrast, transpulmonary pressure obtained using esophageal pressure (Pes) directly reflect lung overdistension risk and lung properties. In order to better understand this new kind of ARDS characterized by modest recruitable profile and to better personalize mechanical ventilation setting and therapy it is obvious to precise transpulmonary pressure.


Eligibility Criteria:
Inclusion criteria:

* Major patients (18-90 years old)
* Hospitalized following SARS-CoV-2
* Mechanical ventilatory support

Exclusion criteria:

* Minor patients