cyrilzakka/clinical-trials huggingface dataset:
Medical Data Collection in the Formation of Precision Oncology Registry

In efforts to develop an aggregation point for patient clinical data and data related to DNA sequencing in the Comprehensive Cancer Center, this registry will be developed to provide a comprehensive data store. The goal of the registry will be to collect information on the Cancer Center population undergoing next generation DNA sequencing (NGS) on their tumors or liquid biopsies.

PRIMARY OBJECTIVES:

I. To capture characteristics of the patient population undergoing next generation deoxyribonucleic acid (DNA) sequencing of their tumor or liquid biopsy for more efficient clinical operations by collecting data on demographics, disease, and previous treatment.

II. To gather information on the number and type of patients that receive off label, standard, timeline or other experimental treatments based on the next generation sequencing (NGS) data.

III. To gather data regarding the patient population that may require financial assistance.

IV. To describe the patient population, in terms of demographic and clinical characteristics, who have consented to have their next generation sequencing data to be linked to their clinical records and used for future research.

V. To collect overall survival for those patients with next generation sequencing data.

VI. To collect outcomes and response to the standard, experimental and/or off label treatment.

OUTLINE: Participants undergo collection of medical data to be used in the formation of a precision oncology registry. Medical data is collected as long as patients are receiving treatment for cancer.

Eligibility Criteria:
Inclusion Criteria:

• All cancer patients at Wake Forest Baptist Comprehensive Cancer Center and its satellites who are having next generation DNA sequencing ordered/performed on their tumor biopsy or surgically resected tissue and/or blood samples.

Exclusion Criteria: Not applicable
Effects of Xanthohumol on Metabolic Syndrome Progression

A huge body of scientific evidence has suggested that xanthohumol (XAN) consumption, a polyphenol present in beer, has a positive effect on energy metabolism. This compound is known for its antioxidant, anti-inflammatory and anti-cancer properties which confer potential to be used as a food supplement. Nevertheless, XAN lipophilic properties prevent the extensive use of this molecule as a functional food compound. The company TA-XAN S.A.M. (Wiesbaden, Germany) has patented a method to overcome this solubility problem. So, the main aim of this study is to evaluate the effects of XAN consumption on metabolic syndrome progression in individuals recently diagnosed.


Eligibility Criteria:
Inclusion Criteria:

* Men and women, 25-65 years of age;
* Criteria for metabolic syndrome according to the 2005 revised NCEP ATP III guidelines:

  * HDL-C \< 40 mg/dL ♂ and \< 50 mg/dL ♀;
  * Triglycerides ≥ 150 mg/dL;
  * Blood pressure ≥ 130/85 mmHg;
  * Fasting plasma glucose ≥ 100 mg/dL;
  * Waist circumference ≥ 102 cm ♂ and ≥ 88 cm ♀;
* HbA1c 5.8/6.0-6.4;
* Nonsmokers or no other tobacco use in the last 3 months;
* Willing to stop taking regular supplements including antioxidants for 2 weeks prior to study entry through conclusion of study;
* Willing to stop consumption of beer for 2 weeks prior to study entry through conclusion of study;
* Must be able to provide informed consent;
* Blood screen tests \[comprehensive metabolic panel (CMP), and lipid profile\] within normal limits or if outside normal limits, approved for participation at the discretion of the study physician.

Exclusion Criteria:

* Have a significant acute or chronic coexisting illness, such as cardiovascular disease, chronic kidney or liver disease, gastrointestinal disorder, endocrine disorder, immunological disorder, metabolic disease, cancer, chemotherapy history, gluten intolerance, eating disorders, depression or any psychiatric condition, diabetes, or any condition which contraindicates entry in the study, according to the investigators' judgment;
* Currently taking prescription drugs other than oral contraceptives (over-the-counter medications are allowed upon review and discretion of the study physician);
* Consumption of more than the recommended alcohol guidelines (\> 1 drink/day ♀ and \> 2 drinks/day ♂);
* Consumption of high levels of beer;
* Pregnancy (as confirmed by urine pregnancy test) or planning to become pregnant before completing the study;
* Breastfeeding;
* Under UV therapy (e.g. psoriasis treatment), using UV tanning beds and unprotected sun exposure greater than 1 hour/day;
* Engaging in vigorous exercise more than 6 hours/week;
* Participation in other dietary study in the past 3 months;
* Had surgery in the last 3 months;
* Post-menopausal status.
Effect of Nervous System Mobilization on Older Adults' Postural Control

This study aims to compare the effectiveness of nervous system mobilization and exercise with exercise only on institutionalized older adults' postural control.

It is anticipated that 26 institutionalized older adults will be randomly allocated to receive either exercise and neural mobilization (n=13) or exercise only (n=13).

Data on pain intensity (a vertical numeric rating scale) and location (body chart), depression (Geriatric Depression Scale), balance, hand grip strength, timed up and go and gait velocity will be collected at baseline, end of treatment and at 3 months follow up.

Statistical analysis will be performed using a mixed-methods ANOVA.

Eligibility Criteria:
Inclusion Criteria:

* be 65 years of age or older;
* to have independent gait with or without technical aid;
* have indication of the institution's doctor for participation in the study

Exclusion Criteria:

* inability to understand study aims.
Combined Application of Diode Laser and Different Remineralizing Agents on White Spot Lesions

Dental caries is a very common condition, and although it has become less common, it still represents a serious public health risk. Caries symptoms range from the earliest molecular alterations in the tooth's apatite crystals to an apparent white spot lesion (WSL) or eventual cavitation. The white spot lesion looks chalky because minerals are being lost from both the surface and the underside of the enamel. A relatively simple and noninvasive caries preventive regimen in treating white spot lesions with low-level laser irradiation, either alone or with topical ﬂuoride treatment. This treatment results in reduced enamel solubility and dissolution.

The study was reviewed and approved by the "Ethical research committee "of the Faculty of Dental Medicine for Girls; at Al-Azhar University, Cairo, Egypt. This study was conducted on 90 teeth with white spot lesions (WSLs) detected clinically on the buccal surface of teeth. The patients with WSLs were selected randomly from the operative dentistry clinic at the Faculty of Dentistry, Girl's Branch, Al-Azhar University

After examination, the teeth will be assigned into six groups of 15 teeth with white spot lesions each according to the remineralizing material used:

* The first group (A1B1): The teeth with WSL will be treated with nano-hydroxyapatite +fluoride with laser application.
* The second group (A1B2): The contralateral teeth will be treated with nano-hydroxyapatite +fluoride without laser application.
* The third group (A2B1): The teeth with WSL will be treated with nano-hydroxyapatite + xylitol with laser application.
* The fourth group (A2B2): The contralateral teeth will be treated with nano hydroxyapatite+ xylitol without laser application.
* The fifth group (A3B1): The teeth with WSL will be treated with 5% sodium fluoride varnish with laser application.
* The sixth group (A3B2): The contralateral teeth will be treated with 5% sodium fluoride without laser application.

Eligibility Criteria:
Inclusion Criteria:

* The patients should be 13-40 years old.
* Patients should have good oral hygiene.
* The patients with good general health and no systemic disease.

Exclusion Criteria:

* - Presence of enamel hypoplasia or dental fluorosis.
* Presence of carious cavity.
* Patients who have a significant medical history,
* Patients who have evidence of reduced salivary flow or significant tooth wear.
Cognitive Behavioral Sleep Intervention for Prevention of Type 2 Diabetes

The proposed study aims to evaluate if improving sleep could enhance the intensive lifestyle intervention for improving weight loss and glycemic control in prediabetic individuals who have insomnia with short sleep duration. A cognitive behavioral intervention for insomnia with adjustments aimed at increasing sleep duration (CBT-Sleep) will be used for this study.


Eligibility Criteria:
Inclusion Criteria:

* (a) Hong Kong residents,
* (b) BMI \> 23kg/m2,
* (c) aged 18 to 65 year-old,
* (d) have prediabetes, defined by a plasma fasting glucose concentration of 5.6 to 6.9 mmol/L, impaired glucose tolerance (2hglucose 7.8-11.0 on OGTT), or HbA1c 5.7-6.4%,
* (e) have average habitual sleep duration \< 6.5 hours, confirmed by actigraphy measure of sleep for 2 weeks or have insomnia, confirmed in a clinical sleep interview and actigraph-measure of greater than 30 minutes of sleep onset latency or nighttime awakening for 3 nights or more per week

Exclusion Criteria:

* (a) have unmanaged sleep apnea or other sleep disorders,
* (b) have any current severe mental illnesses,
* (c) have any medical conditions or medication use that could undermine the efficacy of the sleep intervention,
* (d) have shift work schedules,
* (e) have any environmental constraints on the feasibility of implementing a sleep schedule of at least 7.5 hours
Safety Study of Radiation and CP-675,206 Infusion for Breast Cancer Patients

The purpose of this study is to determine the maximum dose of CP-675,206 when given in combination with radiation. Patients will be given local radiation to one tumor site and an intravenous infusion of CP-675,206.

Breast cancer is the most common cancer in Canadian women. In 2007 an estimated 22,300 women will be diagnosed and 5300 will die of the disease. Despite advances in therapy, metastatic disease remains an incurable illness, with a median survival of only 2 years. Standard systemic treatment options for metastatic disease include chemotherapy or hormonal therapy. Radiation is frequently used in the metastatic setting for palliation of symptoms, with the most frequent site of radiation being bone. Response rates to first line chemotherapy are in the range of 30%, however these responses are not durable. Currently there are no curative options for metastatic disease, underscoring the need for novel therapeutic approaches.

CTLA4 is a receptor expressed on the surface of activated T cells and regulatory T cells. CTLA-blockade has been tested in clinical trials using humanized monoclonal antibodies, and some biological responses have been reported. The anti-tumor immune response may be further augmented by the combination of CTLA4-blockade with radiation, with the potential to mediate regression of metastases outside of the field of radiation. The primary goal of this study therefore is to establish the safety of CTLA4-blockade using the antibody CP-675, 206 in combination with radiation. This trial is being conducted as a prelude to a planned phase II trial of CP-675,206 in combination with radiation in metastatic breast cancer.

Eligibility Criteria:
Inclusion Criteria:

* Inoperable locally recurrent or metastatic breast cancer
* Performance status 0-1
* Adequate organ function as determined by lab tests
* Greater than 3 weeks since any chemotherapy treatment
* Greater than 2 weeks since last dose of hormonal therapy

Exclusion Criteria:

* Previous treatment with any anti-CTLA4 agent
* Patients with active diarrhea
* Patients who will receive radiation to pelvic lesions
* History of chronic inflammatory or autoimmune disorder
* History of insulin-dependent diabetes
* History in the last 5 years of any chronic gastrointestinal conditions
* History within the last year of congestive heart failure, stroke, myocardial infarction or thromboembolic event
* Patients with known brain metastasis
* Concurrent treatment with immunosuppressive medication for longer than 10 days within 4 weeks of enrollment or while on trial
* Patients of reproductive potential not using effective contraception, breast-feeding, or patients who test positive for pregnancy at enrollment
Effect of Interferential l Therapy on Low Back Pain

Background: Chronic non-specific low back pain is defined as unknown mechanical musculoskeletal pain lasting more than 3 months. Electrotherapy is a non-pharmacologic, non-invasive and simple method back pain treatment that is mainly applied using interferential (IF) therapy. The current study was designed to investigate the effect of IF on pain, range of motion, and quality of life in patients with chronic non-specific low back pain. Materials and methods: 61 patients suffered from chronic non-specific low back pain (CNLBP) were randomly assigned to IF group (n=30) and placebo IF (n=31). The entire patient received suggested exercise 3 times per week for 4 weeks. The outcome measures were visual analogue scale (VAS), lumbar range of motion (ROM) in terms of flexion\& extension and the Short Form-36 (SF-36) health questionnaire to evaluate the quality of life (QOL).

Participants The study was conducted in outpatient clinics in Cairo University Hospitals. 60 patients (29 males and 31 females) were invited to participate in the current study. Subjects were included in the study if they had LBP of at least three months duration and aged between 25 and 60 years. Patients with spinal pathology (tumor, nerve root, fracture, and compromise), cardiopulmonary conditions, pregnancy, and received physiotherapy in the last eight weeks or any contraindications to the use of electrotherapy were excluded.

Eligibility Criteria:
Inclusion Criteria:

\*Subjects were included in the study if they had LBP of at least three months duration \* Age between 25 and 60 years.

Exclusion Criteria:

* Patients with spinal pathology (tumor, nerve root, fracture, and compromise),
* Cardiopulmonary conditions
* Pregnancy,
* Received physiotherapy in the last eight weeks
* Any contraindications to the use of electrotherapy were excluded.
Breaking the Bad News to the Bereaved Family and Their Reactions

The demographic characteristics, satisfaction survey evaluations and emotional reactions of the relatives of the patients who are admitted to the intensive care unit and who have an expected mortality rate higher than 50% according to the Apache-2 scoring system will be investigated.

Patients with an APACHE-2 score\> 25 (Expected mortality rate\> 50%) during the first 24 hours of hospitalization in the Intensive Care Unit will be included in the study. A person who comes to the most frequent visit from relatives of patients will be included in the study. Demographic data of the relative of the patient after the informed volunteer consent form has been approved (age, proximity, educational background, patient co-existence, ethnicity, marital status, number of children, history of psychological treatment and the presence of an intensive care treatment history of any family member before) will be registered. After the 3rd, 10th, and 30th days of patient admission, and once a month, the patient satisfaction survey will be filled face to face during informing the patient's relative. In this patient group with an expected mortality of\> 50%, if death occurs, the information will be made to the visitor of the patient who frequently visits the patient and agrees to participate in the study. The emotional reaction of the relative of the patient participating in the study during the declaration of death will be recorded in the case report form.

Grief reaction is unique, and it will differ from one individual to another. Possible reactions of relatives of patients during the death notification (Emotional Reactions)

1. Regular response; In this case, the relatives of the patients often describe the event as expected or my patient is now free from suffering.
2. Initial shock reaction; It may be complete desperation and a state of closure,
3. Denial- This is an initial defense mechanism after the unexpected, devastating news, and it should be recognized and tolerated. Acceptance may be possible by encouraging the relatives to view the body of the deceased, especially to those relatives who were not present at the time of death
4. Anger- This is a common reaction after the sudden death of a beloved relative. The expression of this anger can vary from mild irritation to violent behavior. This can be expressed on self, hospital staff, or any other person. Anger will gradually diminish once expressed
5. Guilt- This is nothing but the inward expression of anger and self-blame. Consoling words of the health care team will help to do away with this emotion.

Eligibility Criteria:
Inclusion Criteria:

* Apache 2 score\> 25 or Expected death rate\> 50%,
* Hospitalization period\> 72 hours in intensive care unit -

Exclusion Criteria:

* Apache 2 score \<25 or Expected death rate \<50%,
* Those who have a stay in ICU \<72 hours
* Currently receiving psychological medication
* Those who do not accept one of the legal heirs to participate in the study
Mentors in Motion: A Physical Activity Intervention for Obese Adolescents

Assesing the impact of mentoring on the lifestyle choices of adolescents who are overweight

Randomized controlled trial of the impact of weekly contacts with mentors to improve physical activity pattern, self esteem, and weight loss in obese teenagers over a 6 month period.

Eligibility Criteria:
Inclusion Criteria:

* 13-17 yo Able to participate in physical activity

Exclusion Criteria:

* On medications that could affect weight
Clinical Study of HR20013 for Injection in Patients With Malignant Solid Tumors

To evaluate the efficacy and safety of HR20013 for injection for prevention of chemotherapy-induced nausea and vomiting after highly emetogenic chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

1. 18 years of age or older, of either gender
2. Has a diagnosed malignant tumor
3. has never been treated with chemotherapy and is to receive the first course of cisplatin-based chemotherapy
4. Predicted life expectancy of ≥ 3 months
5. Has a performance status (ECOG scale) of 0 to 1
6. Adequate bone marrow, kidney, and liver function
7. Women of childbearing potential must have negative pregnancy test (serum test) results within 72 hours prior to enrollment
8. Able and willing to provide a written informed consent

Exclusion Criteria:

1. Scheduled to receive any radiation therapy to the abdomen or pelvis from Day -7 through Day 8
2. Scheduled to receive any other chemotherapeutic agent with an high emetogenicity level from Day 2 through Day 8
3. Has taken the following agents within the last 48 hours 5-HT3 antagonists, Phenothiazines, Benzamides, Domperidone, Cannabinoids, Benzodiazepines
4. Subjects receiving palonosetron hydrochloride within 14 days before randomization
5. Subjects who previously received NK-1 receptor antagonists within 28 days prior to randomization
6. Subjects with a history of myocardial infarction or unstable angina pectoris
7. Subjects with atrioventricular block or cardiac insufficiency
8. Subjects with poor blood pressure control after medication
9. Subjects with symptomatic brain metastases or any symptoms suggestive of brain metastasis or intracranial hypertension
10. Subjects who have experienced emetic events (vomiting or dry vomiting) or nausea within 24 hours before randomization
11. Participated in clinical trials of other drugs (received experimental drugs)
12. The investigators determined that other conditions were inappropriate for participation in this clinical trial
Humanized CD19 Chimeric Antigen Receptor (CAR)-Modified T Cell Therapy in Treating Patients With B-cell Malignancies

This is a single arm, open-label study to evaluate the safety and efficacy of humanized anti-CD19 CAR-T cells in patients with relapsed or refractory B cell Malignancies.

Chimeric antigen receptor (CAR)-modified T cells (CAR-T cells) have the capabilities to recognize tumor associated antigen and kill tumor cells specifically. CAR-T therapy showed great effect on patients with relapsed or refractory B cell malignancies. To improve the efficacy and safety, the researchers designed a second-generation humanized CAR, consisting of humanized CD19 single chain variable fragment (scFv) and CD137 costimulatory domain. This study aims to evaluate the safety and effectiveness of humanized anti-CD19 CAR-T cells in patients with relapsed or refractory B cell Malignancies.

Eligibility Criteria:
Inclusion Criteria:

1. The patient is pathologically and histologically confirmed as CD19 + B cell tumors, and has no effective treatment options currently, such as chemotherapy; or relapsed after auto-HSCT/allo-HSCT; or patients voluntarily choose CD19 CAR-T cells as a first treatment;
2. B cell hematological malignancies include the following three categories:

   A. B-cell acute lymphocytic leukemia (B-ALL);

   B. Indolent B-cell lymphoma (CLL, FL, MZL, LPL);

   C. Aggressive B-cell lymphoma (DLBCL, BL, MCL);
3. Aged from 14 to 70 years old;
4. Expected survival time \> 6 months;
5. Female patients around childbearing age, negative pregnancy test before trial, and agreed to take effective contraceptive measures during the trial until the last visit;
6. Voluntarily participate in this experiment and sign informed consent by themself, or legally authorized representative.

Exclusion Criteria:

1. With a history of epilepsy or other central nervous system diseases;
2. Having graft-versus-host reaction, requires the use of immunosuppressants;
3. The presence of clinically significant cardiovascular disease, such as uncontrolled or symptomatic arrhythmias, congestive heart failure or myocardial infarction within recent six months, or heart disease with cardiac function in any grade 3 (moderate) or 4 ( severe) (according to the New York Heart Association (NYHA) Functional Classification System);
4. Pregnant or lactating women (safety of this therapy for the unborn child is unknown);
5. Not curable active infection;
6. Patients with active hepatitis B or hepatitis C virus infection;
7. Combined use of systemic steroids within two weeks (except use of inhaled steroid recently or currently);
8. Using product of gene therapy before;
9. Creatinine\> 2.5 mg / dl (221.0 umol/L); ALT / AST\> 3 X the normal amount; Bilirubin\> 2.0 mg / dl (34.2 umol/L);
10. Patients suffering from other uncontrolled diseases, and researchers believe that the patient is not suitable for trial;
11. Patients with HIV-infection;
12. Any situation that may increase the risk of patients or interfere with test results.