cyrilzakka/clinical-trials huggingface dataset:
The Relationship Between Intake of Macro and Micronutrients With Clinical Outcomes of Head and Neck Cancer Patients

Cancer is a disease caused by uncontrolled cells growth, and its incidence is increasing worldwide. One of the most common cancer is head and neck cancer (HNC), which has low survival rate. Malnutrition occurrence in HNC lower immune system and as result, decreased survival rate was found. Risk factors including tumor histopathology, nutritional status, immune system, and environment have various effects on life expectancy.

Head and neck cancer treatments such as radiotherapy, chemotherapy, and surgery are not without complications. Xerostomia, stomatitis, anorexia, nausea and vomiting, dysgeusia, ageusia, also pain are commonly found during the HNC treatment procedure, and takes part in further undernutrition findings in HNC patients.

Adequate nutrition management has favorable impact in managing HNC patients' malnutrition related problems. Not only energy intake, but also macronutrients and micronutrients intake have been proved be beneficial in the outcomes of HNC patients. Branched-chain amino acids (BCAA) and zinc are namely two nutrients that have been hypothesized to be beneficent. Branched-chain amino acids are found to increase muscle mass, amino acid pools, and immune system, which resulted in preventing malnutrition and cachexia, also increasing total lymphocyte count in cancer patients. Zinc plays role in immune system, antioxidant process, and taste bud functions. Zinc supplementation is correlated to give a better outcome in taste perception and stomatitis in HNC patients who undergo radiotherapy.

This study aims to finds the correlation between BCAA intake with muscle mass and lymphocyte count in HNC patients who haven't undergone chemoradiotherapy, zinc correlation with gustatory in HNC patients who haven't undergone chemoradiotherapy, zinc correlation with stomatitis in HNC patients who is having radiotherapy treatment, and energy and protein intake with body weight in HNC patients after underwent radiotherapy.


Eligibility Criteria:
Inclusion Criteria:

* head and neck cancer patients who haven't undergone radiotherapy or chemotherapy, during radiotherapy, and after radiotherapy

Exclusion Criteria:

* have contraindications for body composition measuring
* are immunodeficient or have autoimmune disease
* during immunosuppressant drugs treatment
Enhancement of Brain Circuit of Inhibitory Control in Obese Patients Undergoing Gastric Banding

In this project the investigators aim to improve eating control and weight loss outcomes in patients undergoing LAGB with an innovative brain-based intervention. Specifically, the investigators will enhance the activity of the right inferior frontal gyrus, a core region of the brain circuit of inhibitory control, using transcranial direct current stimulation (tDCS).

Laparoscopic Adjustable Gastric Banding (LAGB) is a minimally invasive and reversible procedure in bariatric surgery that has a good safety record. Despite these advantages, success rates following LAGB are quite variable across individuals. Recent data suggest that complementing LAGB with interventions targeting factors along the brain-behavior spectrum could enhance weight loss results following this procedure.

The study will have the following three aims:

Aim #1: To evaluate whether enhancement of the right inferior frontal gyrus with tDCS in patients undergoing LAGB can improve inhibitory control capacity. For this aim the investigators will evaluate participants' performance in a computerized test of inhibitory control. Results from this aim will provide evidence for target engagement, and thus confirm that the brain circuit of interest was affected as a result of the intervention.

Aim #2: To examine whether enhancement of the right inferior frontal gyrus with tDCS in patients undergoing LAGB can lead to improvements in a self-reported measure of eating control (disinhibition subscale of the three-factor eating questionnaire). Results form this aim will provide evidence for an effect of the intervention on an intermediate, behavioral variable.

Aim #3: To preliminary evaluate whether enhancement of the right inferior frontal gyrus with tDCS in patients undergoing LAGB can improve postoperative weight loss outcomes. This aim will provide preliminary evidence for the clinical efficacy of the intervention over a time window period of 12 months. Weight loss at 12 months will be the primary outcome of the study.

Eligibility Criteria:
Inclusion Criteria:

* Age: 20-55 years old
* BMI: 35-60 kg/m2
* Planning to undergo or having undergone laparoscopic adjustable gastric banding (LAGB) within the previous week

Exclusion Criteria:

* Unstable medical conditions including poorly controlled diabetes and hypertension
* Pregnancy or planning pregnancy during study period
* Personal or family history of epilepsy or other unexplained loss of consciousness
* Current or past medical history of skin disease or damaged skin on the scalp at site of stimulation
* Active psychiatric or neurological condition
* Prior neurological procedure
* Implanted pacemaker, medication pump, vagal stimulator, deep brain stimulator, TENS unit, or ventriculoperitoneal shunt
* Intake of common medications that affect the central nervous system will be allowed if determined okay by MD
Geodon for the Treatment of Refractory Social Anxiety Disorder

The purpose of this study is to examine the effectiveness and tolerability of augmentation treatment of ziprasidone to achieve remission among patients with social anxiety disorder (SAD) who did not remit on sertraline treatment alone

This is a two-phase study consisting of 8 weeks of open label treatment with sertraline (50-200 mg/day) in patients with SAD and in those who fail to demonstrate symptom remission on sertraline alone, 8 weeks of randomized, double-blind, placebo-controlled augmentation with ziprasidone.

Eligibility Criteria:
Inclusion Criteria:

* adults 18-65 years of age
* primary diagnosis of SAD, using Diagnostic Standard Manual(DSM-IV) criteria
* minimum Clinical Global Impression of Severity (CGI-S) score of 4 at baseline
* minimum Brief Social Phobia Scale(BSPS) score of 20 at baseline
* written informed consent
* negative serum pregnancy test for women of childbearing potential
* normal EKG

Exclusion Criteria:

* current DSM-IV diagnosis of bipolar disorder, schizophrenia or other psychotic disorder, mental retardation or other pervasive developmental disorder, or cognitive disorder due to a general medical condition
* any current primary anxiety disorder other than SAD
* current primary depression
* history of substance abuse or dependence within the last 3 months
* suicide risk or serious suicide attempt within the last year
* clinically significant medical condition or laboratory or EKG abnormality
* women of childbearing potential who are unwilling to practice an acceptable method of contraception
* patients needing concurrent use of psychotropic medications
* history of hypersensitivity to sertraline or ziprasidone
* recent (less than 2 months) initiation of psychotherapy for SAD
* history of failure to respond to augmentation with an adequate trial of an atypical antipsychotic
* patients who are currently taking any of the following medications: Erythromycin, Biaxin, Avelox, Zithromax, Amantadine, Levaquin, Tamoxifen, Tegretol, Nizoral, and Levitra
An Open-label, Non-randomized, Parallel Group Study in Subjects With Mild, Moderate, Severe, or No Renal Impairment

Multi-center, non-randomized, open-label, single-dose, parallel group study to determine the effect of impaired renal function on the PK of deferiprone and its 3-O-glucuronide metabolite following a single oral dose of 33mg/kg Ferriprox®.

Post-marketing study to evaluate the effect of impaired renal function on the pharmacokinetics (PK) of deferiprone and its 3-O-glucuronide metabolite and on the safety of Ferriprox® in subjects with mild, moderate and severe renal impairment as compared to healthy volunteers.

Eligibility Criteria:
Main Inclusion Criteria:

All subjects:

1. Adult males or females, 18 - 75 years of age (inclusive);
2. Body weight ≥ 45 kg;
3. Body mass index (BMI) range of approximately 18.5-32 kg/m\^2 (inclusive);
4. Absolute neutrophil count (ANC) of \>1.5x10\^9/L;

Healthy volunteers:

1. Medically healthy with clinically insignificant screening results (e.g., laboratory profiles, medical history, vital signs, physical examination);
2. eGFR ≥ 90 mL/min/1.73m\^2;

Renally impaired subjects:

1. Considered clinically stable in the opinion of the Investigator;
2. Subjects with mild renal impairment (eGFR 60-89 mL/min/1.73m\^E2) OR moderate renal impairment (eGFR 30-59 mL/min/1.73m\^2) OR severe renal impairment (eGFR 15-29 mL/min/1.73m\^2).

Main Exclusion Criteria:

1. History of renal transplant;
2. Subjects undergoing any method of dialysis;
3. History or presence of clinically unstable significant respiratory, cardiovascular, pulmonary, hepatic, renal (except for subjects assigned to one of the renally impaired groups), hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease;
4. Disorders or surgery of the gastrointestinal tract which may interfere with drug absorption or may otherwise influence the PK of the investigational medicinal product (e.g. cholecystectomy, resections of the small or large intestine, febrile conditions, chronic diarrhea, chronic vomiting, endocrine disease, severe infections, acute inflammations, etc.);
5. Clinically significant abnormalities on 12-lead ECG (e.g., QTcF≥430 ms in males or ≥450 ms in females);
6. Evidence of liver damage: hepatitis B and C; aspartate aminotransferase (AST), alanine aminotransferase (ALT) that is considered clinically significant by the Investigator;
7. Participation in another clinical trial within 28 days prior to the study drug administration;
Single-ascending Dose Study of Kylo-12 in Healthy Subjects

This is a first-in-human, randomized, double-blind, placebo-controlled, single ascending dose study in healthy volunteers. Kylo-12 will be evaluated in approximately 50 subjects to assess safety, tolerability, pharmacokinetics and pharmacodynamic effects.


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged 18 to 55 years old, inclusive;
* Body mass index (BMI) between 19 kg/m2 and 30 kg/m2, inclusive;
* Protocol-defined elevated serum TG level;
* Female subjects must not be able to get pregnant and male subjects must agree to adhere to contraception restrictions;
* Willing to comply with protocol required visits and assessments, and provide written informed consent.

Exclusion Criteria:

* History or evidence of a clinically significant disorder, condition or disease;
* Received an investigational drug, vaccine or device within 3 months before dosing;
* History of evidence of malignant tumor or Gilbert syndrome;
* Positive screen of Hepatitis B surface antigen, hepatitis C virus, human immunodeficiency virus or syphilis infection;
* History of alcohol abuse within 12 months before dosing;
* History of drug abuse within 3 months before screening;
* History of blood donations or blood loss of 400 ml and more within 3 months before dosing;
* History of stroke or myocardial infarction within 6 months before sceening;
* Pregnant or breast-feeding women;
* Other exclusion criteria applied per protocol.
Paracetamol (Acetaminophen) for Closure of PDA in Preterm Infants

There is a report that acetaminophen may have a role in pharmacological closure of PDA (Patent arterial duct) in preterm infants.

The investigators conducted this open label non randomized and non control study to try to support that report.

In-uteri, the arterial duct connects between the aorta and the main pulmonary artery, thus bypassing the lungs. Since the high pulmonary pressure and the low systemic pressure, the shunt trough the arterial duct in that time is right to left.

After birth, systemic pressure rises and pulmonary pressure declines. As oxygen saturation rises, and prostaglandin secretion, the arterial duct closes, usually. In preterm infants, the arterial duct may remain open after birth. At this tume the shunt would be left to right, that would cause pulmonary congestion, and systemic hypoperfusion.

Ibuprofen is the treatment of choice for PDA in preterm infants. Yet, ibuprofen is not effective after two weeks of age. Moreover, there are situations that prevent treatment with ibuprofen, such as thrombocytopenia or renal failure. Surgical closure of arterial duct is an alternative treatment, if ibuprofen is contraindicated, or if it fails.

Lastly, there was a report that acetaminophen may have a role in pharmacological closure of PDA in preterm infants.

The investigators conducted this open label non randomized and non control study to try to support that report.

Eligibility Criteria:
Inclusion Criteria:

* Preterm infants with symptomatic PDA who could not be treated with ibuprofen

Exclusion Criteria:

* None
Peking University Birth Cohort in Tongzhou

The PKUBC-T is a prospective cohort study carried out in Tongzhou district of Beijing, China. The primary aim of this study is to investigate the short-term and long-term effects of pre-pregnant and prenatal exposure on maternal and child health. Data are collected regarding environmental, nutritional and lifestyle exposures as well as short-term and long-term health outcomes of mothers and their children from birth to 6 years old. Biological samples including blood and tissue samples are also collected from mothers and their children.

Maternal and child health is of great concern globally. Early life phase of a fetus and infant is a critical period for the development of health and disease in the whole life. Exposure of negative environmental, nutritional and lifestyle factors in pregnant women during this period can have adverse effects on fetal and infant. In addition, for mothers, complications during pregnancy could also have a negative effect on long-term health of mothers, such as diabetes, hypertension. Thus, the Peking University Birth Cohort in Tongzhou is primarily aimed to investigate the short-term and long-term effects of pre-pregnant and prenatal exposure on maternal and child health. Data are collected regarding environmental, nutritional and lifestyle exposures as well as short-term and long-term health outcomes of mothers and their children from birth to 6 years old. Biological samples including blood and tissue samples are also collected from mothers and their children.

Eligibility Criteria:
Inclusion Criteria:

1. Pregnant women, \<14 gestational weeks
2. Resided in Tongzhou in the past half years and have no plan to move out after delivery
3. Pregnant women who plan to have antenatal care and delivery in Tongzhou maternal\&Child Hospital.
4. Pregnant women who is willing to participate in this study with informed consent

Exclusion Criteria:

Pregnant women have chronic disease before pregnancy, including diabetes，hypertension, liver disease and kidney disease.
Progression of Cognitive and Physical Symptoms in Multiple Sclerosis

The purpose of this study is to look at multiple sclerosis patients process of awareness, learning, and judging status over a 3 year time period.

Patients with multiple sclerosis (MS) frequently experience cognitive and emotional difficulties. Theses neuropsychiatric symptoms are known to be associated with reduced quality of life. However, little is known about the evolution of MS patients' neuropsychiatric difficulties and how these neuropsychiatric changes may be related to other MS symptoms. The purpose of the present study is to examine MS patients' cognitive and emotional status over time as part of standard neuropsychological evaluations in a private practice setting. MS patients presenting for neuropsychological evaluation at the MidAmerica Neuroscience Institute will be provided with the option of participating in thorough evaluation of their cognitive and affective MS symptoms. They will then be followed clinically and receive re-evaluation over a period of 3 years on a yearly basis. It is hoped that this study will help us obtain a better understanding of the factors associated with worsening cognition in MS. A greater understanding of the factors associated with cognitive and affective decline in MS help could lead to the early identification and treatment of at-risk patients.

Eligibility Criteria:
Inclusion Criteria:

* Male/female subjects at least 18 years of age with a diagnosis of Clinically Definite Multiple Sclerosis (CDMS) or Clinically Isolated Syndrome (CIS)as confirmed by a neurologist.
* Subjects must be able to give written informed consent and comply with the study protocol. Subjects must also be able to read, write and understand English.
* Are capable of performing the requirements of the neuropsychological test battery.

Exclusion Criteria:

* As judged by the investigator, any clinically significant, unstable or major concomitant disorder or medications.
* In the opinion of the Investigator should not participate in the study.
Investigation of The Effects of Holistic Group Exercise Program on Muscle Thickness and Physical Performance in Older Adults With Sarcopenia

A decrease in muscle mass and function can cause the development of many chronic diseases, including sarcopenia. It has been reported that the best intervention for sarcopenia is exercise. Despite this, the optimal type of exercise for sarcopenia has not yet been determined. Although the holistic approach is used in the literature in the elderly population, it is noticeable that it does not find much space for itself in this patient group. In this study, it was aimed to examine the effects of holistic approach-based exercise program on individuals with sarcopenia.


Eligibility Criteria:
Inclusion Criteria:

* Being over the age of 65
* Getting a diagnosis of sarcopenia
* To be able to walk at least 10 meters independently in public
* Getting a score of 4 and above from the clock drawing test
* Volunteer individuals

Exclusion Criteria:

* Having a neurological disease
* Having an uncontrollable cardiopulmonary disease
* Acute illness that will prevent him/her from understanding and performing the exercises to be performed status or the presence of significant cognitive impairment
* Providing continuity for less than 80% of the exercise program
Virtual Ileostomy Versus Conventional Loop Ileostomy

This study aimed at comparing the Comprehensive Complication Index (CCI), readmission rates, postoperative hospitalization days, duration of bearing the stoma (months), hospitalization costs, the number of hospitalizations with ghost ileostomy versus conventional loop ileostomy after low anterior resection for rectal cancer.

Diverting ileostomy (DI) is a common procedure performed in patients undergoing low anterior resection for rectal cancer to protect the anastomosis and reduce the risk of complications. Although DI remains one of the most common methods used in clinical practice to prevent anastomotic leakage, there is still considerable debate in clinical practice about whether to perform a routine ileostomy. Despite temporary ileostomy fecal diversion can reduce the development of abdominal abscesses, wound inflammation, peritonitis, and sepsis after the occurrence of AL, however, it not only failed to reduce the incidence of AL but significantly increased the risk of non-elective readmissions and reinterventions as well as higher total costs. Meanwhile, stoma significantly increase the risk of stoma-related complication such as small bowel obstruction, postoperative ileus, dehydration from high-output stoma culminating in acute kidney injury, electrolyte imbalance, stoma stenosis/ necrosis, parastomal hernia, peristomal abscess, and fistula, etc.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed low to intermediate level rectal cancer, with the lower margin of anastomosis \<10cm from the anus.
* age ≥18 years and ≤80 years.
* the surgical procedure is anterior rectal resection (LAR).
* intraoperative virtual or conventional ileostomy was performed.

Exclusion Criteria:

* BMI \>30 kg/m².
* ASA score \>3.
* Patients with coexisting complete intestinal obstruction.
* History of long-term use of immunosuppressive drugs or glucocorticoids.
* Combined severe cardiac disease: with congestive heart failure or NYHA cardiac function ≥ grade 2. Patients with a history of myocardial infarction or coronary artery surgery within 6 months prior to the procedure.
* chronic renal failure (requiring dialysis or glomerular filtration rate \<30 mL/min).

Intraoperative combined multi-organ resection.

* Combined cirrhosis of the liver.
* Intraoperative findings of incomplete anastomosis and positive insufflation test.
The Effects of Sildenafil on Exercise Function and Capacity in Patients With Fontan Circulation

The study will test the hypothesis that a single dose of sildenafil can increase the exercise capacity of pediatric patients with a Fontan Circulation.


Eligibility Criteria:
Inclusion Criteria:

* Age 6-17 years
* Male or female
* Possess Fontan Circulation

Exclusion Criteria:

* Severe heart failure (New York Heart Ass. functional class IV)
* Evidence of Fontan pathway obstruction
* History of exercise-induced severe arrhythmias
* Pregnancy (known or suspected)
* Orthopedic limitations that prevent ambulation on a treadmill
* Use of nitroglycerin
* Herbal medications
An Investigational Immuno-therapy Study of BMS-986205 Given in Combination With Nivolumab and in Combination With Both Nivolumab and Ipilimumab in Cancers That Are Advanced or Have Spread

The purpose of the study is to determine safety and effectiveness of experimental medication BMS-986205 when combined with Nivolumab and in combination with both Nivolumab and Ipilimumab in patients with cancers that are advanced or have spread. Pharmacokinetics and pharmacodynamics of BMS-986205 when combined with Nivolumab and in combination with Nivolumab and Ipilimumab in this patient population will also be assessed.


Eligibility Criteria:
For more information regarding Bristol-Myers Squibb (BMS) Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* During dose escalation, subjects with advanced solid tumors that have progressed following at least one standard regimen
* During cohort expansion, subjects with advanced cancer that either have received at least one prior therapy or are treatment naive, depending on the specified tumor type
* Subjects must have measurable disease
* Subject must consent to provide previously collected tumor tissue and a tumor biopsy during screening.
* At least 4 weeks since any previous treatment for cancer
* Must be able to swallow pills or capsules
* Eastern Cooperative Oncology Group(ECOG) Performance Status 0-1

Exclusion Criteria:

* Active or chronic autoimmune diseases
* Uncontrolled or significant cardiovascular disease
* History of any chronic Hepatitis, active Hepatitis B or C, human immunodeficiency virus (HIV), or acquired immune deficiency syndrome (AIDS)
* Chronic hepatitis: Positive test for Hepatitis B virus surface antigen or Hepatitis C antibody (except for subjects with hepatocellular carcinoma)
* Active central nervous system (CNS) metastases and CNS metastases as the only sites of disease
* Active infection

Other protocol defined inclusion/exclusion criteria could apply