cyrilzakka/clinical-trials huggingface dataset:
The Effects of Mechnikov Probiotics on Symptom and Surgical Outcome

The purpose of this clinical trial study was to evaluate the prevalence of colon cancer among the symptom (s) of anterior resection syndrome that may occur after surgery in patients for efficacy and safety in Metchnik probiotic ingestion.

The purpose of the clinical trial is to evaluate the efficacy and safety of the syndrome that may occur after colon cancer surgery, To evaluate the efficacy and safety of the improvement effect of the defecatory activity on the improvement of the Medienkov probiotics biotics on the patients who have the deficit function and planned to surgery.

Eligibility Criteria:
Inclusion Criteria:

1. Adult male or female aged 20 to over 75 years old
2. As histologically and radiologically diagnosed S colon cancer, those who is scheduled for anterior resection
3. Those who have been agreed to participate in this trial (through Informed consent) before initiation of clinical trial.

Exclusion Criteria:

1. Those who have metastatic colorectal cancer screening
2. Those who have urinary incontinence or fecal incontinence
3. Those who received preoperative chemotherapy or radiotherapy
4. Those who have a history of severe cerebral vascular disease (cerebral infarction, cerebral hemorrhage, etc.), severe cardiac disease (unstable angina pectoris, myocardial infarction, arrhythmia requiring heart failure heart failure therapy)
5. Those who have neurologist or psychologically important psychiatric history or current disease
6. Those who have alcohol addiction, substance abuse
7. Those who have Immune system, infectious infectious disease, gastrointestinal tract disease patients (inflammatory bowel disease)
8. Those who have uncontrolled hypertension, diabetes patients
9. Those who have creatinine with more than twice from normal upper limit in site
10. Those who have AST(GOT) or ALT(GPT) with more than three times from normal upper limit in site
11. Those who have probiotics, antibiotics, continually within the last one week
12. Those who is pregnant women, breastfeeding women and have pregnancy plans or do not agree to appropriate contraception methods choice
13. Those who have been participated within three months or have plans to participate in another clinical trial after the start of this clinical trial
14. under the investigator's judgment, those who is not qualified to participate this clinical trial
Study Comparing Product 0405 to a Vehicle Control in the Treatment of Mild to Moderate Atopic Dermatitis in Pediatric Subjects

The purpose of this study is to evaluate the safety and efficacy of product 0405 in pediatric subjects with Mild to Moderate Atopic Dermatitis.

Treatment medication will be administered topically twice daily for 28 days

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Atopic Dermatitis
* Good health with the exception of Atopic Dermatitis
* Percent body surface area minimum requirements

Exclusion Criteria:

* Subjects who are pregnant, nursing or planning a pregnancy
Anti-Pseudomonas Immune Status and Dendritic Cell Preparation in Normal Individuals

This protocol aims to collect human peripheral blood mononuclear cells for the production of dendritic cells (DC). There are two ways to collect human peripheral blood mononuclear cells in this protocol. One is by using the method of leukapheresis from normal healthy adults. The other is by drawing the blood from normal healthy adults and then getting the buffy coats from the blood.

One objective of these studies on DC is to complete a preclinical development for a human study of a candidate anti-Pseudomonas aeruginosa vaccine consisting of autologous dendritic cells primed with heat-inactivated P. aeruginosa (PA) strain POA1 and expressing the T-cell costimulatory molecule CD40 ligand (CD40L). The other objective is to complete a preclinical development for a human study of a candidate anti-anthrax vaccine. Prior to testing the vaccine in humans, the Food and Drug Administration will require preclinical and Good Manufacturing Practice (GMP) practice batches of dendritic cells. The intent of the leukapheresis or collecting the buffy coats is to provide the biological materials for this purpose.

Eligibility Criteria:
Inclusion Criteria:

* All study subjects must be capable of providing informed consent.
* Normal male or female, age 18 and older.
* Not taking corticosteroids
* Not taking any prescription or over-the-counter medication, except acetaminophen (tylenol)
* Participants of Group A must have adequate peripheral veins for leukapheresis
* Study subjects should not be taking experimental medications.
* Females cannot be pregnant.

Exclusion Criteria:

* Individuals who do not meet the inclusion criteria will be unable to participate in the protocol.
* Individuals with active infection in the 3 weeks prior to beginning the protocol will not be able to participate.
* Individuals with evidence of significant cardiac, pulmonary, renal, endocrine, central nervous system, major psychiatric disorder that would prevent compliance or substance abuse, musculoskeletal disease or immunodeficiency disease, (including evidence of human immunodeficiency virus infection, HIV) will be unable to participate in the protocol.
* Individuals participating in any other experimental clinical studies.
* Women who are pregnant or nursing.
* Active or recent drug users
Effectiveness of Telemedicine Care Replacing Standard Care in Gestational Diabetes

This is a a single-centre, parallel, randomized controlled trial in women with gestational diabetes mellitus (GDM). Women are randomized to routine monthly prenatal clinic care (standard care group) or a group sending daily glucose readings via an application installed on a smartphone and monthly individual videoconferences replacing in-person visits (telemedicine group). The overall aim is to compare the effectiveness of the combine synchronous and asynchronous telemedicine care with the standard care in women with GDM.

In our single-centre, parallel, randomized controlled trial in women with gestational diabetes (GDM) the investigators aim to compare the effectiveness of combined synchonous and asynchronous telemedicine care with the standard care.

In the telemedicine group appointments are performed online via monthly scheduled videoconferences. Women also receive a smartphone with the installed application that enable transfer of the measured capillary glucose concetration at the same time it is performed. The glucose data sent by women are reviewed once per week and after that healthcare professionals contact women if necessary. On the other hand, in the standard care group, visits are scheduled normally on a monthly basis at the diabetes clinic.

Intention-to-treat analysis is going to be performed. The investigators aim to compare glycemic control, gestational weight gain and perinatal data between groups.

Student's t-test or Mann-Whitney U test will be used for normally or non-normally distributed variables. Differences between groups in categorical data will be calcuated by Chi square.

Eligibility Criteria:
Inclusion Criteria:

* less then 30 weeks of gestation at enrolement
* GDM diagnosis
* at least moderate Slovenian language skills
* willingness to participate

Exclusion Criteria:

* more than 30 weeks of pregnancy
* overt diabetes or fasting glucose \>6.9 mmol/l at diagnosis
* multiple pregnancy
* poor Slovene language skills
* history or bariatric surgery or other surgeries that induce malabsorbtion
* use of systemic steroids prior to enrolment
* presence of concomitant disease that could affect glucose control or self-management (e.g. uncontrolled psychiatric disorder)
Quality Of Life While Receiving Faslodex

To study QoL related response, symptom spectrum and severity in disseminated breast cancer patients receiving Faslodex hormonal therapy.


Eligibility Criteria:
Inclusion Criteria:

* Histologic and/or cytological proven breast cancer.
* Patients with metastases of breast cancer ± postmenopausal primary tumor ≥12 months.
* Positive oestrogen receptors (ER+), positive progesterone receptors (PgR+) or unknown hormonal receptors (if duration between surgery and metastasis occurring is not less 2 years) which are indirect confirmation of hormone sensitive tumor.
* ECOG performance status of ≤ 2
* Patient willingness to take part in the programm
* Life expectancy of more than 6 months.
* Patient ability to complete a questionnaire.

Exclusion Criteria:

* Contraindications for Faslodex therapy
* Other anticancer therapy (chemotherapy, hormonal therapy with other drugs, radiotherapy), except for radiotherapy of sites which are not only measurable or evaluable manifestation of disease.
Study of Biomarkers Associated With Fatigue in Patients With Early-Stage Breast Cancer Treated With Metformin or Placebo on NCIC-CTG-MA.32

RATIONALE: Studying samples of blood in the laboratory from patients with breast cancer may help doctors learn more about changes that occur in DNA and identify biomarkers related to fatigue.

PURPOSE: This research study is studying biomarkers associated with fatigue in patients with early-stage breast cancer treated with metformin or placebo on NCIC-CTG-MA.32.

OBJECTIVES:

* To prepare, separate into components, and store the blood specimens at the NSABP Serum Bank at Baylor College of Medicine Breast Center for future DNA, RNA, and plasma analysis, and to analyze specific proinflammatory cytokines, genetic polymorphisms, and RNA expression arrays in collaborating laboratories at University of California, Los Angeles (UCLA).
* To examine the association between markers of inflammation and symptoms of fatigue among patients with and without exposure to metformin hydrochloride.
* To examine the relationship between single nucleotide polymorphism (SNPs) in the promoter regions of IL-1 and IL-6 and symptoms of fatigue with and without exposure to metformin hydrochloride.
* To examine RNA expression profiles in relationship to fatigue and compare the pattern of expression in patients with and without exposure to metformin hydrochloride.
* To determine the biological and behavioral predictors of fatigue in breast cancer patients in the five years post-randomization.
* To determine whether metformin is associated with reductions in inflammatory markers and corresponding decreases in fatigue. (Exploratory)

OUTLINE: This is a multicenter study.

Patients' serum and plasma, collected at baseline and at 6, 12, and 24 months after NCIC CTG MA.32 randomization, are analyzed for inflammatory markers, DNA polymorphisms, and RNA expression arrays by ELISA, TaqMan PCR, and RT-PCR.

Patients complete the Fatigue Symptom Inventory (symptoms associated with fatigue, sleep disturbance, depression, and endocrine therapy) at baseline and periodically during study.

Eligibility Criteria:
Inclusion Criteria

* The patient must have consented to participate and must have signed and dated an appropriate IRB-approved consent form that conforms to federal and institutional guidelines for the MA.32.F Study before being enrolled.
* The patient must be female.
* The patient must reside in the United States or Canada.
* The patient must be English-speaking.
* The patient must be eligible for randomization in the MA.32 treatment trial. (Participation in the MA.32 QOL study is permitted but not required.)
* The patient must not have started taking MA.32 study therapy.
* The patient must have completed primary breast radiation therapy at least two weeks prior to enrollment in MA.32.F.

Exclusion Criteria

* MA.32 study therapy has been initiated.
* Currently receiving radiation therapy or additional radiation therapy is planned for initiation after starting MA.32 study therapy.
Cancer Within a Pandemic: A Telemental Health Intervention

The purpose of this research study is to test an online support group designed to help young adults who have had cancer treatment to manage their mood during a pandemic. Investigators hope to learn more about what effects a support group may have upon the health and well-being of young adults who have undergone cancer treatment by offering an online support group that teaches healthy coping skills in a practical and acceptable way. Investigators would also like to know if certain parts of the online material is more effective in helping subjects manage their mood.

Primary Objective: To improve self-efficacy for young adult cancer survivors navigating pandemic conditions.

Secondary Objective: To reduce depression and anxiety levels through meaning-making.

Eligibility Criteria:
Inclusion Criteria:

* Documented cancer diagnosis within the Wake Forest Baptist Medical Center medical record;
* Outpatient Cancer Survivor (diagnosis, treatment, or post-treatment);
* Aged 18-39
* Must speak English
* Must have computer with audio and visual capabilities.
* Must live within North Carolina
* Must have experienced health-related anxiety and/or distress in last 3 months.

Exclusion Criteria:

* Exclusion criteria will be determined by pre-screening data and medical chart reviews
* Active inpatient hospitalization
* Major cognitive impairment, marked concerns with working memory, concentration, or word finding difficulties that significantly impairs daily functioning documented in most recent clinic note or self-reported
* Recent suicide attempt(s), psychiatric hospitalization, or psychotic processing (last 3 years)
* Bipolar disorder (I or II) diagnosis, as evidenced by an ICD-10 code within the past year or revealed during subject interview
* Moderate to severe alcohol or drug abuse; as evidenced by an ICD-10 codes related to alcohol or illicit substance abuse in the medical record within the past year or revealed during subject interview.
* Severe eating disorders; as evidenced by an ICD-10 code in the medical record such as anorexia nervosa or bulimia within the past year or revealed during patient interview
* Repeated "acute" crises for example: repeated acute crises consisting of marked psychological distress that impairs function and warrants clinician intervention (e.g., occurring once a month or more frequently); this we be evaluated by the clinician screener.
Study Of Treximet, Formerly Known as Trexima, In The Acute Treatment Of Multiple Migraine Attacks

The purpose of this study is to determine the consistency of response for Treximet (formerly known as Trexima) when treating four acute migraine attacks at the mild pain phase and within 1 hour of onset of head pain.


Eligibility Criteria:
Inclusion Criteria:

* At least a 6 month history of physician diagnosed migraine and typically experiences 2-6 migraine attacks per month.
* Typically experiences moderate to severe migraine pain preceded by a mild pain phase.
* Differentiate between mild migraine pain and other headache types.
* Women of childbearing potential must be on adequate contraception.

Exclusion Criteria:

* Pregnant and/or nursing mother.
* History of cardiovascular disease.
* Uncontrolled hypertension.
* Basilar or Hemiplegic migraine.
* History of stroke or transient ischemic attacks (TIA).
* History of epilepsy or treated with anti-epileptics within past 5 years.
* Impaired hepatic or renal function.
* History of gastrointestinal bleeding or ulceration.
* Allergy or hypersensitivity to Aspirin or any other NSAID.
* Allergy or hypersensitivity to triptans.
* Participated in an investigational drug trial in the previous 4 weeks.
Construction of Gynecological Tumor Sample Library

Constructing a gynecological tumor samples library, which is open and can be accessed.

This project is the construction and maintenance of a gynecological tumor sample library. It is supported by the National Key Laboratory of Difficult, Severe, and Rare Diseases at Peking Union Medical College Hospital of the Chinese Academy of Medical Sciences. This project will lay a clinical specimen foundation for exploring the molecular mechanisms of gynecological tumors in the future.

Eligibility Criteria:
Inclusion Criteria:

1. An informed consent form was obtained. If the age is less than 18 years old, the consent form should be signed by the guardian.
2. Preoperative tumor burden assessment and intraoperative evaluation by the supervising physician (professor) suggest sampling is acceptable.
3. The research team believes that sampling is possible.
4. Having the relevant requirements for sample library storage.
5. Surgical treatment is performed at Peking Union Medical College Hospital.

Exclusion Criteria:

1. Not meeting all inclusion criteria.
2. The research team considers any circumstances or considerations that may hinder normal pathological evaluation.
Novel Device for Screening Patients With Symptoms of OSA

An innovative ring type oxymetry will be wore by patient undergoing sleep study to validate it's accuracy and usefulness as a screening device for patients with symptoms of OSA


Eligibility Criteria:
Inclusion Criteria:

* Patients above 18 years old and below 70 years old, both men and women

Exclusion Criteria:

* Patients requiring oxygen therapy or noninvasive ventilation;
* Patients with a diagnosis of chronic obstructive pulmonary disease, chronic heart failure, neuromuscular disease, insomnia, clinical symptoms of parasomnia, periodic limb movement, or narcolepsy.
* Patients on medication known to interfere with heart rate, such as beta-blockers, digoxin or calcium receptor antagonists.
Telomere Parameters in Patients With Nonalcoholic Fatty Liver

Telomerase, through its regulatory function on telomere length may play an important role in immune function, cellular replicative life span, and carcinogenesis. Non-alcoholic fatty liver disease (NAFLD) is considered a benign condition, but in some cases, it may progress to cirrhosis and hepatocellular carcinoma. The risk factors for that evolution are not fully understood.

Our group showed in a previous study, that hTERT mRNA expression is lower in peripheral lymphocytes of patients with fatty liver, compared to healthy controls. This finding could explain the telomere shortening found previously in these patients by our group \[20\] and others \[21\]. Furthermore, we found higher rates of TC in these patients, probably due to an attempt to counteract the shortening of the telomeres and to stabilize them. This is through a different mechanism that is not telomerase-mediated.

Telomere capture is considered an alternative way to maintain telomere length and chromosomal stability \[3\]. It is a more common mechanism for chromosome stabilization and repair, in contrast to the telomerase-mediated process of chromosome healing and elongation This study aimed to evaluate mechanisms of telomere homeostasis like telomere shortening, telomerase activity, telomere capture and aneuploidy in patients with NAFLD in order to explain previous findings of telomere shortening in these patients.


Eligibility Criteria:
Inclusion Criteria:

* age over 18
* diagnosis of fatty liver

Exclusion Criteria:

* no malignancy
* no eligible to sign the consent paper
PORCINE XENOGRAFT OR MICROBIAL CELLULOSE IN THE TREATMENT OF PARTIAL THICKNESS BURNS

The purpose of this study was to compare two wound dressing products for partial thickness burns in adults.

After being informed about the study, all patients that had given written informed consent underwent screening. If eligible study participants were randomized to be treated wih either the standard dressing of care; pigskin or a microbial cellulose. Dressing were applied within 72 hours after burn injury. Evaluation was done in an open manner due to the specific characteristics of the dressings. Study particpants were followed weekly until complete wound closure and after that evaluated at 6 and 12 months after injruy for burn scar outcome.

Eligibility Criteria:
Inclusion Criteria:

* Study participants admitted within 72 hours of injury
* partial-thickness burns requiring a temporary skin cover
* written informed consent

Exclusion Criteria:

* severe coexisting cutaneous trauma
* chronic or current skin disease,
* severe cognitive dysfunction or psychiatric disorder
* pregnant or breast feeding women were excluded.
Monopolar Electrosurgery Versus Ultrasound Scissors in Thoracoscopic Ventral Spondylodesis

This study was undertaken to investigate the effect of using ultrasound scissors in the preparation for Thoracoscopic Ventral Spondylodesis. Quantity of bleeding and the duration of operation in Thoracoscopic Ventral Spondylodesis are compared to the preparation with monopolar electrosurgery.

One group of patients will be operated on using ultrasound scissors in the preparation during Thoracoscopic Ventral Spondylodesis. The other group will be operated on using Monopolar Electrosurgery.

The study is designed as a randomized trial. That means that all patients who have given their consent to participate in the study will be allocated to either ultrasound scissors or Monopolar Electrosurgery by chance.

A total of 40 patients will be included in this study. The study ends with finishing of the first day after the operation, there is no longer follow up.

Eligibility Criteria:
Inclusion Criteria:

* informed consent
* fracture of vertebral bodies Th10-L2 with indication for operative treatment

Exclusion Criteria:

* missing informed consent
* mission indication for operative treatment
* revision of the trailing edge
* clotting inhibition therapy
* ASA III/IV
* pregnancy
* malfunction of liver Child C
Body Composition in Preschool Children

Thailand has been facing with the double burden of malnutrition. Many studies in Thailand, which aim to explore the situation, causes, and strategies to prevent obesity, have focused on adults, adolescents, or school-aged children. Few studies have been conducted in preschool children. Obesity or stunting during childhood increases the risk of being obesity in adulthood and leads to chronic diseases. If obesity is established in adulthood, it is difficult to reduce the excess weight. Thus, the prevention of obesity or stunting in young children should be highly considered. Study of dietary pattern and reliable field methods to measure fat mass (FM) in children may partly contribute to primary prevention of childhood obesity. The deuterium dilution technique is an accurate and suitable method for children and population-based studies. However, it has not been widely used in children in Thailand. Hence, this study aimed to utilize the deuterium dilution technique for assessing body composition and to determine the quality and quantity of dietary intake among children 3-5 years of age with different nutritional status. We conducted a cross-sectional study in 15 daycare centers in Nakhon Pathom and Samut Prakarn provinces. 120 preschoolers were purposively selected according to their nutritional status: stunted, thin, normal, and overweight/obese. Anthropometric measurements were conducted. Body composition was determined based on total body water using deuterium dilution technique. Dietary intake data were obtained using 2-day 24 hr recall.We hypothesized that stunted and obese children will have more fat mass compared to the normal children.

Body composition of the children was assessed using the deuterium technique. Total body water (TBW) content was calculated. Then, fat free mass (FFM) and fat mass (FM) was calculated.

Weight and height of all children were using a standard technique. Body mass index and nutritional status was calculated using World Health Organization (WHO) growth standard for children 0-5 years.

Dietary intake of children was assessed using 2 non-consecutive 24 hour dietary recalls. The 1st and 2nd recall was about 2 weeks apart. Nutrient intake was calculated using the INMUCAL-Nutrients WD. 4.0 (Institute of Nutrition, 2010).

Eligibility Criteria:
Inclusion Criteria:

* Healthy children
* Aged 3-5 years
* BMI or HAZ fall in the study protocol

Exclusion Criteria:

* Chronic diseases
* Ongoing medical treatments likely to affect body composition
* Malformation or muscle diseases