cyrilzakka/clinical-trials huggingface dataset:
Epigenetic Priming Using Azacitidine With Neoadjuvant Chemotherapy for Resectable Esophageal Cancer

The purpose of this study is to see whether giving azacitidine before each cycle of chemotherapy prior to surgery is safe.

Currently patients with resectable (can be removed by surgery) esophageal cancer will receive chemotherapy before surgery to try to shrink the tumor before it is removed. This study will evaluate whether giving azacitidine before each cycle of chemotherapy to increase the shrinkage of the tumor prior to surgery is safe.

Azacitidine is currently approved by the Food and Drug Administration (FDA) for treatment of myelodysplastic syndrome (MDS). Azacitidine is not approved by the FDA for use in this study and is therefore considered investigational. Because azacitidine has not been given before in combination with epirubicin, oxaliplatin and capecitabine, we will also evaluate the safety and tolerability of azacitidine and find out what dose of azacitidine is safe to give with this chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed adenocarcinoma or poorly differentiated carcinoma of the intrathoracic esophagus or gastroesophageal junction (GEJ) and deemed resectable by the thoracic surgeon.
* No prior chemotherapy for esophageal or GEJ cancer.
* ECOG Performance status 0-2.
* Adequate bone marrow, kidney and liver function.
* Ability to understand and the willingness to sign a written informed consent document.
* Subjects of child-bearing potential must agree to use effective means of contraception (men and women).
* Prior malignancy is acceptable if the subject is considered to be cured. In most cases this will mean a 5-year disease-free period.

Exclusion Criteria:

* Patients with cervical esophageal cancer or esophageal cancer with squamous cell carcinoma morphology.
* Subjects receiving any other investigational agent or received prior chemotherapy for esophageal or GEJ cancer.
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to azacitidine, epirubicin, oxaliplatin, capecitabine and mannitol.
* New York Heart Association (NYHA) Grade II or greater congestive heart failure.
* History of myocardial infarction or unstable angina within 6 months prior to study enrollment.
* Pregnant (positive pregnancy test) or lactating women.
* Patients with active infection, serious inter-current medical conditions.
Prophylactic Continuous Positive Airway Pressure (CPAP) in Delivery Room, in the Prevention of Transient Tachypnea of Newborn (TTN): A Randomized Controlled Trial

Transient Tachypnea of the Newborn (TTN) is a disorder of delayed clearance of lung liquid and a common cause of admission of full term infants and late pre term infants (34 to 36 weeks) to Neonatal Intensive Care Units (NICU). Both late preterm gestational age at delivery, and mode of delivery are considered risk factors for TTN. The investigators hypothesize that CPAP administered prophylactically in the Delivery Room via a T piece based infant resuscitator Neopuff, to neonates at increased risk for TTN, would decrease the incidence of TTN and thus decrease the need for hospitalization in the NICU. This is a pilot study to evaluate the prophylactic administration of CPAP in the Delivery Room towards prevention of TTN and it's effects on natriuretic peptides.The study will be conducted as a randomized control trial after obtaining informed consents from the parents of eligible infants. Infants will be randomized to receive either experimental treatment (prophylactic CPAP) or standardized care.


Eligibility Criteria:
Inclusion Criteria:

* Babies born to mothers via elective CS: elective CS defined as planned CS in the absence of Labor.
* Late preterm infants (34 1/7 to 36 6/7 weeks gestational age)

Exclusion Criteria:

* Presence of any of the risk factors for neonatal sepsis such as Prolonged Rupture of Membranes for ≥18 hours (PROM), maternal fever, maternal chorioamnionitis or positive maternal GBS colonization
* Need for use of PPV for perinatal depression or other indications
* Presence of any of the following

  * congenital malformations (diagnosed prenatally)
  * chromosomal anomalies (diagnosed prenatally)
  * congenital heart disease diagnosed by fetal echocardiography.
Learning Enhancement Through Neurostimulation in Autism

This study will examine whether brain stimulation paired with social skills learning can help teenage boys with autism learn how to make and keep friends. Brain stimulation can enhance learning in some people. This study involves enrolling in a 14-week training program where teenage boys with autism interact in small groups and learn social skills. During the 14-week program participants will receive active brain stimulation, or non-active stimulation (placebo). Before and after this training, MRI scans will be taken to see whether the training with active brain stimulation made a different in brain activation.


Eligibility Criteria:
Inclusion Criteria:

* Autism Spectrum Disorder

Exclusion Criteria:

* Intellectual Disabilities (Full-scale IQ \<70)
* Hx of seizures within the last one year
* Contraindications for fMRI, such as metal implants in the head
The Role of Partial Hydrolyzed Guar Gum in High Stoma Output Management Among Cancer Patients With Ileostomy

this is a cross sectional intervention study to investigate the role of partial hydrolyzed guar gum in high stoma output management among cancer patients with ileostomy. This study hypotheses there is improvement in stoma output in PHGG if compare with control. There are two groups of subjects in this study. Conventional group (CG) will include retrospective historical data (those subjects with post-operative ileostomy) from Jan 2016 to June 2019. Intervention group (PHGG) will be subjects with ileostomy which involves prospective intervention by giving partial hydrolyzed guar gum upon start orally. Data on stoma output (volume \& consistency), length of hospital stay, readmission within 30-days discharged and dietary intake will be recorded in data collection form.


Eligibility Criteria:
Inclusion Criteria:

* Cancer patients with ileostomy
* At least 18 years of age
* Malaysian

Exclusion Criteria:

* Not cancer patients with ileostomy
* Patients who participate in other study at the same time
* Vulnerable subjects
* Palliative patients
* Patient has fistula
Prevalence of Medical Care in an Emergency Structure of the Women Victims of Violence Within the Couple

Violence against women within the couple is a major socio-political and public health problem.

Indeed, in 2020, 219,000 women were victims of violence within their couple and 102 women were killed by their partner or ex-partner.

On average, the number of women aged 18 to 75 who in the course of a year are victims of rape and/or attempted rape is estimated at 94,000 women, and in 47% of cases it is the spouse or the ex-spouse who is the author of the facts.

This violence has major health and social consequences: the leading cause of death and disability among women aged 16 to 44 in Europe. In France, a woman dies as a result of domestic violence every 2.5 days and the overall cost of domestic violence in 2012 amounted to 3.6 billion euros in France.

A better knowledge of the use of care for wives of victims of violence and their feelings vis-à-vis the medical care in an emergency service will make it possible to identify the problems related to their care based on their feelings. of these patients, to understand why they would not have consulted as a first resort if necessary and to subsequently propose avenues for improvement.


Eligibility Criteria:
Inclusion Criteria:

* Adult women (age ≥ 18 years old)
* victims of violence committed within the couple
* Initial visit to the emergency room or not
* Subject not opposed to participating in the study

Exclusion Criteria:

* Intra-family violence committed by a parent, outside the couple (for example: father, grandfather, brother, cousin, uncle, child)
* Impossibility of giving informed information to the subject (subject in an emergency situation, difficulties in understanding the subject, etc.)
Instrumented vs. Conventional Perturbation-based Balance Training for Fall Prevention

In the past years, several studies have demonstrated the potential of task-specific perturbation-based balance training (PBT) for preventing falls at age. However, different paradigms of PBT have been investigated so far, while a comparison of these paradigms is lacking. Therefore, in this study, we plan to compare two promising PBT approaches in terms of feasibility and effects on fall risk-associated motor performance: 1. Training of dynamic stability mechanisms in the presence of perturbations induced by unstable surfaces; 2. Technology-supported training on a perturbation treadmill. In addition, both approaches will be compared with a passive control group. One-hundred and eleven participants aged 65 years or older will be randomly assigned to the three arms of the study. As the primary outcome, we will assess fall risk by use of the Brief-BESTest. Secondary outcomes include balance performance, functional performance, force capacity, and more. We hypothesize that both interventions will lead to a significant reduction of fall risk compared to the control group. Additionally, we will explore whether one of the two PBT paradigms is superior regarding feasibility and effectiveness.


Eligibility Criteria:
Inclusion Criteria:

* Aged 65 years or older
* Speaks German language
* Home-dwelling or assisted living
* One fall in the past 12 months OR a verified fall risk (based on subjective decreased balance AND extended Short Physical Performance Battery (SPPB) balance testing
* Able to walk at least 20 minutes without aid
* Available for intervention period

Exclusion Criteria:

* Participation in balance training in the previous 3 months
* DemTec ≤ 8 Points
* Body mass index \> 30
* Uncorrected vision disorder
* Acute serious neurological disability affecting gait pattern
* Serious sensory disorders
* Severe cardiovascular or metabolic disorders
* Orthopaedic restrictions or diseases
* Strong dizziness
* Current chemotherapy
* Severe respiratory disease
Accumbofrontal Tract Study in 2 Populations of Patients With Anorexia Nervosa and Obsessional Compulsive Disorder and Healthy Volunteer

Restrictive anorexia nervosa and TOCs are psychiatric diseases which shares a common pathophysiological substrate We hypothesize that anorexia patients and patients with OCD have structural and functional changes in the accumbofrontal tract. The main objective of this study will be to compare the structure and the connectivity of this tract in MRI with diffusion sequences (DTI tractography) and resting-state, in 3 distinct populations of anorexic patients, patients with OCD and healthy patients. The role of the accumbo-frontal tract in the cortico-striato-hypothalamo-cortical circuit seems to be established. DTI tractography will allow the measurement of functional anisotropy (FA), a parameter that evaluates the diffusion of water molecules along the white matter fibers, and therefore the potential alteration of the studied tract. Resting state sequences will allow to estimate the BOLD signal and the functionality of the tract.


Eligibility Criteria:
Inclusion Criteria:

* Female patients
* Age between 18 and 65 years
* Subjects free to give their written consent

For anorexia nervosa :

* Patients meeting the diagnostic criteria for anorexia nervosa according to DSM5 (American Psychiatric Association): low weight (\<85% of expected weight for age and height), fear of gaining weight or becoming fat, distortion of body image, and amenorrhea for more than 3 months
* Treatment with at least one antidepressant and one anxiolytic

For OCD :

* Patients meeting the diagnostic criteria of OCDs according to DSM5 (American Psychiatric Association) : presence of obsessions and / or compulsions, resulting in clinically significant suffering (loss of at least one hour per day) or impairment at the social, occupational level or in another important area of life. These symptoms are not due to the physiological effects of a substance or a general medical condition and cannot be better explained by the symptoms of another psychiatric disorder.
* Patients with homogeneous OCD in obsession and compulsion.
* Normal weight compared to expected weight for age and height
* Treatment with at least one antidepressant and one anxiolytic

ForHealthy volunteer

•Normal weight compared to expected weight for age and height

Exclusion Criteria:

* Male
* Age \<18 years or\> 65 years
* Pregnancy
* Absence of free and informed consent signature
* Current processing by rTMS
* Somatic intercurrent pathologies: neurological, cardiological, pneumological, renal, hepatic, endocrine, metabolic disorders ...
* Mental retardation (WAIS-IV QI \<70)
* Primary Amenorrhea
* Absolute contraindication or relative to the realization of a magnetic resonance imaging without injection of contrast medium
* Old or intercurrent psychotic pathology
Phase 3 Trial to Evaluate the Efficacy and Safety of DKP21102_B Added on to DKP21102_A Compared With DKP21102_A

Phase 3 study to evaluate the efficacy and safety of DKP21102_B Added on to DKP21102_A Compared with DKP21102_A

Phase 3 study to evaluate the efficacy and safety of DKP21102 in patients with mixed dyslipidemia where LDL-C is properly controlled but triglyceride and HDL-C levels are not regulated by DKP21102_A alone.

Eligibility Criteria:
Inclusion Criteria:

* A man or woman over 19 years old.
* Patients with coronary heart disease or risk of coronary heart disease

Exclusion Criteria:

* History of Unstable angina, myocardial infarction etc
* Uncontrolled hypo-thyroidism (TSH≥1.5XULN), Diabetes(HbA1c ≥ 9.0%)
* renal impairment (Creatinine clearance \< 60 mL/min) etc.
Exploring Two Treatments for Misophonia

While the investigators continue to work on better understanding Misophonia, it is also important to identify treatments that can help people who are currently suffering. Further, it is important that the treatments provided are acceptable to the people who receive them. In this study, participants will complete one of two treatments the investigators believe can help manage symptoms of Misophonia: The Unified Protocol or process-based therapy. Both treatments will use evidence-based psychological principles (e.g., managing attention or behavior) in a flexible manner and will focus on developing skills to help reduce the distress and impairment associated with Misophonia. The aims of this study are (1) to explore the acceptability and feasibility of these treatments for individuals who experience Misophonia and (2) to examine whether these treatments help reduce symptoms associated with Misophonia.


Eligibility Criteria:
Inclusion Criteria:

* Over age 18
* Able to read English
* Meet criteria for interfering symptoms of misophonia
* Live in North Carolina

Exclusion Criteria:

* Under age 18
* Current mania
* Current psychotic disorder
* Current anorexia
* Presents with a condition that requires immediate prioritization in treatment (e.g., suicide planning or intent)
* Has received any treatment specifically for misophonia in the past year
Kinesiotaping in Carpal Tunnel Syndrome

Objective: Kinesiotaping (KT) is a relatively new technique, which reduces the pressure on the median nerve by extending the transverse carpal ligament. The aim of this study was to evaluate the effectiveness of KT on Carpal tunnel syndrome (CTS) in a randomized, placebo-controlled manner.

Methods: Patients were randomly divided into three groups: Group 1 (KT plus tendon and nerve gliding exercises), Group 2 (sham-taping plus exercises) and Group 3 (exercises alone, control group). KT was applied 3 times with 5-day intervals throughout the study, with "neural technique" for median and ulnar nerves and "area correction technique" for carpal tunnel releasing. In the placebo group kinesiotapes were applied without stretching and proper position. Hand grip strength, VAS, Boston Carpal Tunnel Syndrome Questionnaire (BCTQ), and Short Form-12 (SF-12) were measured as outcome parameters at the first visit, 3rd and 6th week.


Eligibility Criteria:
Inclusion Criteria:

* clicical diagnosis of mild and moderate CTS
* having the CTS symptoms for at least 6 weeks

Exclusion Criteria:

* electrophysiological diagnosis of severe CTS,
* thenar atrophy,
* local corticosteroid injection or KT application or physical therapy treatment for CTS within the last 3 months,
* patients with secondary metabolic causes for CTS (such as diabetes mellitus, pregnancy, rheumatoid arthritis, sarcoidosis, thyroid disease),
* patients with other conditions that may cause neck and arm pain (cervical disc hernia, arthritis, epicondylitis, rotator cuff syndrome),
* a history of fracture in the wrist,
* previous CTS surgery.
Expanded Access to Provide Larotrectinib for the Treatment of Cancers With a NTRK Gene Fusion

Larotrectinib expanded access is for patients with cancer with a NTRK1, NTRK2, or NTRK3 gene fusion, who are ineligible for an ongoing larotrectinib clinical trial or have other considerations that prevent access to larotrectinib through an existing clinical trial. Gene fusion occurs when a gene is made by joining parts of two different genes. NTRK gene fusion can lead to the development of solid tumors in a variety of tissue types. The study drug larotrectinib blocks the action of the NTRK gene fusion.

Expanded access is intended to treat individual patients with different types of cancers with a NTRK gene fusion who are unresponsive to current standard treatment for their condition and also are unable to participate in ongoing clinical trials.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of cancer with a NTRK1, NTRK2, or NTRK3 gene fusion
* Subjects are unable to participate in an ongoing larotrectinib clinical trial
* Medically suitable for treatment with larotrectinib

Exclusion Criteria:

* Currently enrolled in an ongoing clinical study of larotrectinib or another TRK inhibitor
Postprandial Lipemia and Glycemia Following a High-Fat Meal

The goal of this clinical trial is to determine the acute effects on postprandial lipemia and glycemia by supplementing a high-fat meal with either white button (WB) or shiitake (SH) mushroom powder in relatively healthy adults, aged 18 to 35.


Eligibility Criteria:
Inclusion Criteria:

* generally healthy
* non-diabetic
* normal to mildly hypercholesterolemic (Total Cholesterol 200-239 mg/dL and LDL-C 130-159 mg/dL)
* have BMI \<30 or BF% (men \<25%, women \<32%)
* no known disease of the liver or gallbladder
* no documented problems with fat metabolism
* normal lipemic response to a lipid challenge
* No known mushroom allergy

Exclusion Criteria:

* diabetic
* pregnant
* BMI \>30
* liver disease
* gallbladder disease
* mushroom allergy
* lipid disorder
Measurement of Natural Killer Cell Activity in Whole Blood in Men Being Screened for Prostate Cancer With Biopsy

This study will look at measuring the activity of natural killer (NK) cells using the in vitro diagnostic device NK Vue in subjects being screened for prostate cancer using prostate biopsy.

The NK Vue diagnostic test for natural killer cell activity uses the principle of stimulation of whole blood with a proprietary cytokine followed by the quantitative detection of interferon-gamma using an immunoassay. NK Vue is intended to be used for the monitoring of the immune status of individuals. Measurement of NK cell activity could be a useful tool for assessing changes in immunosurveillance in patients with conditions or diseases where NK cell activity has been shown to be affected.

Eligibility Criteria:
Inclusion Criteria:

1. Male aged ≥ 18 years old
2. Able to read and sign an approved informed consent form
3. Soon to be undergoing a needle prostate biopsy for suspected prostate cancer; patients with a history of prior biopsy are not excluded provided the biopsy was negative
4. All prior and current recorded PSA levels are \< 11 ng/mL (minimum of 2 values must be available)
5. Digital Rectal Exam performed or scheduled to be performed prior to biopsy

Exclusion Criteria:

1. Any other established malignancy with the exception of basal cell carcinoma
2. At time of blood collection, an active infection (eg bacterial, viral etc.) as declared by the patient
3. Chronic inflammatory condition requiring anti-inflammatory treatment such as rheumatoid arthritis, Crohn's or ulcerative colitis, Lupus or any connective tissue condition which, in the opinion of the investigator, might affect the immune response
4. Presently taking any of the following classes of medications on a regular basis:

   * 5-alpha reductase inhibitors
   * Anti-inflammatories, with the exception of low dose (81 mg) acetylsalicylic acid
   * Anti-androgens
   * Testosterone replacement therapy
Transition From Research to Disclosure in Human Genetics

The goal of this study is to design a means of providing research families, from diverse geographical locations, the chance to receive genetic testing after having been educated by video, and meetings or telephone conversations with a genetic counselor/study professional.

This is an investigational study. About 800 people will be offered genetic testing. This study is being performed only at MD Anderson.

Participants will receive pre-test genetic counseling in one of three ways: (1) in person at MD Anderson; (2) by telephone with an MD Anderson Genetic Counselor/study professional; (3) with a local Genetic Counselor in conference with the MD Anderson Genetic Counselor/study professional. After receiving pre-test genetic counseling, participants will be given the opportunity to schedule a submission of a small sample of blood (about 6 tablespoons) for genetic testing for p53. You may have this blood test repeated if there are any problems in the lab. The study doctor will discuss this with you.

Participants who submit a sample may choose to see a genetic counselor/study professional in person or schedule a phone conversation to receive the results of the genetic test. Genetic counseling may take place at MD Anderson at no cost. Participants may wish to have counseling close to their home, though they then are responsible for the cost of the counseling. If, after talking to the counselor/study professional, the participant wants to know the results of the test, he or she will be told. A participant will be given more counseling and advice on what other care might be needed and what other actions they should take.

The test results will be kept private. Names will not be used in computer records.

Eligibility Criteria:
Inclusion Criteria:

2.0 Genetic testing

Members of families who have participated in the p53 project through Dr. Strong's lab are eligible, via protocol P90-001. There are at least 145 kindreds including at least 800 participants living who may be at risk of carrying a p53 germline mutation. The participants must provide an informed consent and be 18 years or older. We will include English and non-English speaking participants. For non-English speaking participants to be recruited, the consent documents has been translated into the language of the target population in accordance with the IRB procedures.

2.1 Parents Attitudes toward testing children at risk for TP53 mutations

For the survey portion of this study, we will invite individuals who 1) are already enrolled in the P90-001 study), 2) have been known to carry a germline p53 mutation, and 3) have children who are less than 27 years old. Patients who agree to enroll in the survey portion of the study will be presented with a consent statement and a printed copy of the survey along with a postage-paid envelope which they can return (either by mail or in person) at their convenience.

2.2 Psychosocial impact of participating in LFS screening

1. Adults who have undergone genetic testing and have a confirmed p53 mutation
2. Adults participating in LFS screening program

Exclusion Criteria:

N/A