cyrilzakka/clinical-trials huggingface dataset:
Usefulness of the Artery First Approach in Pancreatic Cancer Surgery

This study is aimed to evaluate difference of the 2 year recurrence free survival after pancreaticoduodenectomy for pancreatic cancer between artery-first approach and conventional procedure groups.

The patients will be divided into 2 groups

conventional group: The patients who included this group will undergo conventional pancreaticoduodenectomy (PD) or pylorus preserving pancreaticoduodenectomy (PPPD). We will identify and isolate superior mesenteric vein (SMV) before pancreatic resection. The surgeon will dissect tissue around superior mesenteric artery (SMA) and uncinate process of pancreas along the SMA.

Experimental group:

The patients who included this group will undergo PD or PPPD including total pancreatic mesopancreas excision and superior mesenteric artery approach. Before pancreatic transection, the surgeon will isolate superior mesenteric vein (SMV) and superior mesenteric artery (SMA). And the surgeon will dissect nerve plexus and lymph node around SMA. inferior pancreaticoduodenal artery (IPDA) and first jejunal artery will be identified and the surgeon will ligate according to surgical margin. Anastomosis will be performed as usual manners.

Postoperative manage is same in two groups. The investigators will compared 2 years recurrence free survival rate between conventional and experimental groups.

Eligibility Criteria:
Inclusion Criteria:

* Resectable pancreatic head cancer
* No systemic metastasis
* Age \> 20 years
* The patients who understand informed consent and is able to agree with study

Exclusion Criteria:

* The patients who have systemic metastasis
* The patients who need neoadjuvant therapy in borderline resectable and locally advanced pancreatic cancer
* Those with active or uncontrolled infections
* Those with severe psychiatric / neurological disorders
* Alcohol or other drug addicts
* Patients with moderate or severe comorbidities who are thought to have an impact on quality of life or nutritional status (cirrhosis, chronic kidney failure, heart failure, etc.)
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells for NAION

This trial will study the safety and efficacy of intravenous and sub-tenon delivery of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for the treatment of non-arteritic ischemic optic neuropathy

This patient funded trial aims to study the safety and efficacy of intravenous and sub-tenon delivery of cultured allogeneic adult umbilical cord derived mesenchymal stem cells (UC-MSCs) for the treatment of non-arteritic ischemic optic neuropathy. The total dose will be 100 million cells. Patients will be evaluated within one month pre treatment and at 1, 6, 12, 24, 36, and 48 months post treatment for safety and efficacy.

For patients with more severe disease an autologous Effector cells (activated lymphocytes) treatment will be utilized created from the patient's own cells obtained by apheresis.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of NAION (non-arteritic ischemic optic neuropathy)
* Understanding and willingness to sign a written informed consent document

Exclusion Criteria:

* Active infection
* Active cancer
* Chronic multisystem organ failure
* Pregnancy
* Clinically significant Abnormalities on pre-treatment laboratory evaluation
* Medical condition that would (based on the opinion of the investigator) compromise patient's safety.
* Continued drug abuse
* Pre-menopausal women not using contraception
* Previous organ transplant
* Hypersensitivity to sulfur
Mitochondrial Dysfunction in Phelan-McDermid Syndrome

The purpose of this study is to determine whether a relationship exists between gene deletion(s) specific to the mitochondrial electron transport chain and presentation of clinical characteristics in patients with Phelan-McDermid Syndrome (PMS).

Phelan-McDermid Syndrome (PMS) results from a deletion within the 22q13 chromosome region. Most children have specific physical morphology and developmental delays with many displaying characteristics of autism spectrum disorder (ASD) including abnormalities in social development. The behavioral aspect of PMS that parallels ASD has raised particular interest as the SHANK3 gene, which lies in the 22q13 region, is important for synaptic development, and animal SHANK3 knockout models demonstrate ASD characteristics thereby confirming the importance of this gene in PMS. However, despite the importance of the SHANK3 gene, individuals with PMS have variations in their development, behavior and medical characteristics that cannot be fully explained by the SHANK3 deletion.

Recently, Frye (2012) has noted the existence of 6 mitochondrial genes that lie slightly proximal to the SHANK3 gene within the 22q13 region. These include genes important electron transport change function (SCO2, NDUFA6), mitochondrial DNA (TYMP) and RNA (TRMU) metabolism, fatty acid metabolism (CPT1B) and tricarboxylic acid cycle function (ACO2). Since most Individuals with PMS have deletions that include chromosomal deletion outside of the SHANK3 region, it is very likely that many, if not most, of children with PMS may have deletions in these mitochondrial genes. Many of these genes have been linked to mitochondrial disease, even in the heterozygous state. Even if recognized, mitochondrial disease is only linked to a homozygous abnormal state (autosomal recessive), the loss of one gene (heterozygous state) could result in symptomatology when associated with deletions in other mitochondrial or non-mitochondrial genes. Abnormalities in mitochondrial pathways can result in neurologic and non-neurologic symptoms including those sometimes seen in children with PMS. Added with the SHANK3 deletion, abnormalities in these mitochondrial genes could explain variations in patterns of development and the eventual cognitive potential.

References: Frye RE. Mitochondrial disease in 22q13 duplication syndrome. J Child Neurol. 2012; 27(7):942-9.

Eligibility Criteria:
Inclusion Criteria:

* 1-21 years of age
* Diagnosed with Phelan-McDermid Syndrome AND diagnosed with Mitochondrial Disorder
* Diagnosed with Phelan-McDermid Syndrome

Exclusion Criteria:

* none
Waitlist Controlled Comparison of Cognitive-behavioral vs. Mindfulness-based Online-treatments for Women With Low Sexual Desire

Problems with sexual function are common and distressing. The most frequent sexual difficulty in women is a lack of sexual desire with a prevalence of 20-30%. When low sexual desire is experienced over several months and causes significant personal distress, a sexual dysfunction can be diagnosed (ICD-10: Hypoactive Sexual Desire Disorder: HSDD). A distressing lack of desire is reported by 6% of sexually active women. Psychological interventions are the treatment of choice for women with HSDD. Promising treatment approaches include cognitive-behavioral and mindfulness-based interventions. A recent meta-analysis also showed that Internet-delivered programs are a valid alternative to face-to-face treatments. Aim of this project to assess the effectivity of two eight-week online-programs consisting of cognitive-behavioral (COPE) and mindfulness-based (MIND) interventions for women with HSDD. Both treatments will be compared to a waitlist-control group. For this project, two well-established group-treatment manuals will be translated into German and adapted to a multimedia online-environment. All participants will be guided through the programs by well-qualified eCoaches.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* female gender
* able to read, write and speak German
* Meet criteria of ICD-10 criteria of Hypoactive Sexual Desire Disorder (established via online-screening and telephone interview)
* Experience significant sexuality-related personal distress (established via online-screening and telephone interview)

Exclusion Criteria:

* currently pregnant
* ongoing medical or psychological treatment for low desire or other sexual dysfunctions or plans to enter such treatment (e.g., in-person sexual therapy, couples therapy) during study participation
* suicide ideation (established via telephone interview)
* currently experiencing significant symptoms of a mental disorder that might interfere with study participation (e.g., Eating Disorders, Obsessive-Compulsive Disorder, Posttraumatic Stress Disorder, Major Depression, Bipolar Disorder) as established via telephone interview
* currently experiencing significant symptoms of a physical condition that might interfere with study participation (e.g., cancer, multiple sclerosis) as established via telephone interview
* current Substance-Abuse Disorder
* current or lifetime Psychotic Disorder
* significant relationship discord or violence
Gender-based Differences in the Outcome of the Treatment of Persistent Septic Shock With Hydrocortisone

The aim of this study is to explore the gender-based differences in the outcomes of treatment with hydrocortisone in critically ill patients with persistent septic shock.

Because of their pleiotropic effects, corticosteroids are widely used as adjunctive therapy in sepsis for their anti-inflammatory, metabolic, and immune-suppressing actions. Moreover, the treatment benefits of corticosteroids in terms of hemodynamics and organ functions for septic shock were established. Hydrocortisone reduces the duration of mechanical ventilation and critical care treatment and reduces the time needed for shock reversal. Hydrocortisone use at a daily dose of ≤400 mg for at least 3 days was associated with survival benefits.

Interestingly, corticosteroid treatment was reported to be more cost-effective in females than in males with septic shock, compared with placebo. This may be explained by the fact that sex hormones modulate the expression and sensitivity of glucocorticoid receptors differently, potentially influencing the body's response to cortisol. To the best of our knowledge, the data available on whether females and males may be more or less likely to acquire a better or worse prognosis of persistent septic shock when treated with hydrocortisone is sparse.

The aim of this study is to explore the gender-based differences in the outcomes of treatment with hydrocortisone in critically ill patients with persistent septic shock.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients of both sexes with persistent septic shock received hydrocortisone during their intensive care unit (ICU) stay.

Exclusion Criteria:

* Patients with incomplete data sets.
A Study to Evaluate Laser Speckle Contrast Imaging to Assess Changes in Chemical Agent-Induced Skin Blood Flow in Healthy Participants (MK-0000-420)

Pain is a significant issue and there is a need for better treatments for pain management. Local changes in skin blood flow can be used as an indicator of pain in the body. Capsaicin and allyl isothiocyanate (AITC) increase blood flow and cause pain. The purpose of this study is to evaluate the use of laser speckle contrast imaging (LSCI) as a tool to assess changes in skin blood flow. Researchers want to learn about the effect size and reproducibility of using LSCI to measure the blood flow response to capsaicin and AITC.


Eligibility Criteria:
Inclusion Criteria:

* Is in good health based on medical history, physical examination, vital sign measurements, and electrocardiograms performed before randomization
* Has a skin surface without significant skin allergies, pigmentary disorders or active dermatological conditions that may interfere with the conduct of the laser speckle contrast imaging (LSCI) assessment

Exclusion Criteria:

* Has a history of clinically significant endocrine, gastrointestinal, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases
* Has a history of stroke, chronic seizures, epilepsy, peripheral neuropathy or other clinically significant neurological disease or cognitive impairment that are severe enough to interfere with assessment of pain (sensory) systems
Changes in Adiponectin and Cardiovascular Disease Risk Factors in Overweight Patients

This study aimed to determine if eight-weeks of exercise-based cardiac rehabilitation could improve adiponectin and cardiovascular disease risk factors in overweight coronary heart disease patients. Patients were included in the study if: they were approved to do so following a physical, physiological and psychological test; did not take part in regular physical activity; had stable heart failure for at least 3 months. Exclusion criteria included: a history of surgery within the preceding 4 months; had an unstable angina, acute phase of myocardial infarction, and/or unstable arrhythmia; had obstructive cardiomyopathy, exercise-induced ischemia or arrhythmias, uncontrolled arrhythmias, resting blood pressure more than 200/120 millimeters mercury, aortic stenosis, and/or peripheral artery disease; exercise limitations due to neuromuscular and/or musculoskeletal disease; had any health problems that prevented maximum effort on the treadmill test. Target population included of all patients with a history of myocardial infarction and diagnosis of congestive heart failure who were referred to Isfahan Cardiovascular Research Centre. 60overweight coronary heart disease patients were randomly assigned to either an eight-week, three times weekly exercise group (n=30), or a non-exercising control group (n=30). Exercise sessions took place at 60-85% of maximal heart rate, lasted 45-60 minutes and included a 10-minute warm-up, 40 minutes of aerobic exercises, consisting of stationary cycling, walking and/or jogging, flexibility, balance exercises, and weight-bearing activity and a 10-minute cool-down.


Eligibility Criteria:
Inclusion Criteria:

* they were approved to do so following a physical, physiological and psychological test; resided and worked in the city of Isfahan; did not take part in regular physical activity; had stable heart failure for at least 3 months.

Exclusion Criteria:

* a history of surgery within the preceding 4 months
* had an unstable angina, acute phase of myocardial infarction (MI), and/or unstable arrhythmia
* had obstructive cardiomyopathy, exercise-induced ischemia or arrhythmias, uncontrolled arrhythmias, resting blood pressure more than 200/120 millimeters mercury (mmHg), aortic stenosis, and/or peripheral artery disease
* exercise limitations due to neuromuscular and/or musculoskeletal disease, such as any type of orthopedic, low back pain, bone fracture of less than 6 months
* uncontrolled systemic disease, such as DM; were 75 years or older
* had any health problems that prevented maximum effort on the treadmill test
* unable to answer the screening questionnaires assessing depression and anxiety.
Breathlessness Assessment in Adult Patients With Myotonic Dystrophy Type 1

Myotonic dystrophy type 1 (DM1) is one of the most common neuromuscular diseases in adults. As respiratory dysfunction is the most common cause of death in patients with DM1, a respiratory disease progression must be monitored combining symptom screening and respiratory function testing, in order to identify the appropriate time to initiate non invasive ventilation (NIV).

Dyspnea, one of the main respiratory symptoms, has been little studied in patients with DM1.

The main objective of this study is to provide the first multidimensional description of dyspnea in patients with DM1.

The secondary objectives are:

* To compare respiratory symptoms according to the presence or not of criteria from respiratory function testing to initiate NIV
* To assess associations between dyspnea and respiratory function testing
* To assess associations between dyspnea and number of Cytosine Thymine Guanine (CTG) repeats
* To assess associations between dyspnea and muscular strength
* To assess associations between dyspnea and BMI
* To assess associations between dyspnea and anxiety or depression
* To assess associations between dyspnea and cognitive impairment
* To assess associations between dyspnea and quality of life.


Eligibility Criteria:
Inclusion Criteria:

* patient with myotonic dystrophy type 1 confirmed by genetic analysis
* with an age older than 18 years

Exclusion Criteria:

* an ongoing or recent (i.e. within the last 4 weeks prior to study recruitment) medical condition, including pulmonary exacerbations
* patient already under non-invasive mechanical ventilation
A Study Evaluating IPI-926 in Combination With Gemcitabine in Patients With Metastatic Pancreatic Cancer

Study IPI-926-03 is a Phase 1b/2 clinical trial to evaluate IPI 926 in combination with gemcitabine in patients with previously untreated metastatic pancreatic cancer. Phase 1b is designed as a dose escalation study. Once the maximum tolerated dose of IPI-926 in combination with gemcitabine is established in the Phase 1b portion of the study, the Phase 2 portion will commence.

Phase 2 is designed as a randomized, double-blind (investigator/patient), placebo-controlled study. There is no cross-over option for patients in either arm of the Phase 2 (i.e., there is no option for patients receiving placebo to cross-over to IPI-926).

IPI 926 is an inhibitor of the Hedgehog Pathway. IPI-926 in combination with gemcitabine may improve therapeutic outcomes in patients with pancreatic cancer. Infinity is conducting a Phase 1b/2 clinical trial to evaluate the safety and efficacy of IPI-926 in combination with gemcitabine in patients with previously untreated metastatic pancreatic cancer.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age
* Pathologically confirmed metastatic pancreatic adenocarcinoma
* At least 1 radiologically evaluable metastatic lesion (RECIST 1.1).
* ECOG 0 or 1
* Life expectancy ≥3 months.
* All women of child bearing potential, all sexually active male patients, and partners of patients must agree to use adequate methods of birth control
* Ability to adhere to the study visit schedule
* Voluntarily signed an informed consent form

Exclusion Criteria:

* Islet cell, acinar cell carcinoma, non-adenocarcinoma, (i.e., lymphoma, sarcoma), adenocarcinoma originated from biliary tree or cystadenocarcinoma
* Prior treatment with chemotherapy for pancreatic cancer.
* Known central nervous system metastases
* Inadequate hematologic function
* Inadequate hepatic function
* Inadequate renal function
* External (percutaneous) biliary drain
* History of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control within the last 6 months.
* Venous thromboembolic event (e.g., pulmonary embolism or deep vein thrombosis) requiring anticoagulation not appropriately anticoagulated or have NCI CTCAE Grade 2 or greater bleeding episode in the 3 weeks prior to administration of IPI-926
* Concurrent administration of the medications or foods known to inhibit CYP3A activity to a clinically relevant degree
* Presence of active infection or systemic use of antibiotics within 72 hours of treatment
* Significant co-morbid condition or disease which in the judgment of the Investigator would place the patient at undue risk or interfere with the study.
* Known human immunodeficiency virus (HIV) positivity
* Known hypersensitivity to gemcitabine, IPI-926, or their excipients
* Pregnant or lactating women
A Study Evaluating PF-03084014 In Patients With Advanced Breast Cancer With Or Without Notch Alterations

This study is designed to evaluate the preliminary anti-tumor activity and tolerability of PF-03084014 when administered as a single agent in the treatment of patients with advanced triple receptor-negative breast cancer (mTNBC) harboring genomic alterations in Notch receptors (NA+), and in a smaller subset of mTNBC patients whose tumor tests negative for genomic alterations in Notch receptors (NA-)


Eligibility Criteria:
Inclusion Criteria:

* Histological or cytological diagnosis of triple negative breast cancer (TNBC) with evidence of a) metastatic or b) locally recurrent advanced disease that is not amenable to resection or radiotherapy with curative intent.
* Availability of an original diagnostic tumor tissue or the most recent metastatic tumor biopsies (archival biopsy or de novo biopsy) and a peripheral blood sample for Notch receptors genomic profiling

Exclusion Criteria:

* Known brain metastases.
* Prior treatment with gamma secretase inhibitor or other Notch signaling inhibitor.
PHYSICAL ACTIVITY AS COPING STRATEGY FOR ACADEMIC STRESS AMONG UNDERGRADUATE FEMALE COLLEGIATE STUDENT

Physical Inactivity is one of the major cause causing academic stress in students, so effectiveness of Light, moderate and vigorous physical activity as a baseline treatment were assessed through academic stress scale questionnaire, Cohen Perceived stress Scale and rapid assessment of physical activity (RAPA).

A total of 388 students participated in first phase of study and total 60 students with moderate academic stress were filtered. Among those only 37 were physically inactive from last one month by the assessment through RAPA (Rapid assessment of physical activity). ASS (Academic stress scale), Cohen Perceived stress Scale and RAPA questionnaires were used to collect data. Three equally distributed groups were given three different modes of physical activities i.e light, moderate \& vigorous.

Eligibility Criteria:
Inclusion Criteria:

* Undergraduate female students between 18-24 years.
* Students with moderate level of academic stress
* Students inactive from last one month

Exclusion Criteria:

* Students with any other type of stress
* Students with other psychological disorders
* Student with known systemic disease.
* Physically active from last one month were excluded.
Heart and Kidney Ketones Metabolism

Participants will undergo 3 Positron Emission Tomography (PET) scans in 3 different conditions :

1. Fasting without exogenous ketone salt
2. Fasting with exogenous ketone salt supplement
3. Post-Prandial with exogenous ketone salt supplement.

This study will help to quantify heart and kidney ketone uptake with or without an exogenous ketone salt with or without food intake in middle-aged adults. Participants will have 3 different PET scan to perform :

1. Fasting without exogenous ketone salt
2. Fasting with exogenous ketone salt supplement
3. Post-Prandial with exogenous ketone salt supplement.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 45 and 64
* Generally Healthy
* BMI between 18.5 and 27

Exclusion Criteria:

* All drugs taken on a daily basis
* Diabetes or pre-diabetes
* Digestive dysfunction
* Pregnancy or lactation
* Allergy to the supplement
* Participate in an intensive physical exercise training (more than three times a week)
* Being on a ketogenic diet or consumption of ketogenic supplement.
* More than 2 alcoholic beverages each day
* Any clinically significant anomaly in the blood profile
* Smoking
* Claustrophobia
* Being enrolled in another interventional research project or in a PET research project
* Unable to lie dorsally supine for at least 60 minutes