cyrilzakka/clinical-trials huggingface dataset:
A Research About Nutrition Impact for Local Advanced Nasopharyngeal Carcinoma Patients

The chemo-radiotherapy for the local advanced nasopharyngeal carcinoma patients will induce the mucosal ulcer and damage salivary glands. Consequently, it can disturb the nutrition conditions and clinical outcomes of patients. This research tries to evaluate the nutrition status at the baseline, before and after radiotherapy, during the follow-up by the body mass index, hematological indexes, immunological indexes, and nutrition questionnaires including PG-SGA and NRS 2002. Through the evaluation of two different nutritional interventions, the investigators aim to find an optimized assessment model and the best nutrition support patterns.

All nasopharyngeal patients received radical treatment including neo-adjuvant chemotherapy and concurrent chemo-radiotherapy. At the beginning, the investigators assign patient to experimental and control groups randomly. Patients in experimental group received standard nutritional support by adding NUTRISON. Control patients will give conventional nutritional guidance. The investigators collected all the nutritional indexed at first visit, before and after radiotherapy, 1, 3, 6, 9, 12 months after radiotherapy. All these data will be set into statistical software to produce an optimized model for clinical practice.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically conformed Initial nasopharyngeal carcinoma
2. Patients can feed through the mouth.
3. ECOG (Eastern Cooperative Oncology Group) : 0-2.
4. No history of chemo-radiotherapy, immuno-therapy or biotherapy.
5. Normal hemodynamic indices before the recruitment (including white blood cell count\>4.0×109/L, neutrophil count\>1.5×109/L, platelet count \>100×109/L, hemoglobin≥90g/l, normal liver/kidney function).
6. Informed consent signed.

Exclusion Criteria:

1. History of malignant tumors.
2. Any severe complications contraindicated chemotherapy or radiotherapy.
3. Medical history of central nervous system, cognitive or psychological diseases;
4. Pregnant or nursing women.
5. Patients with mental disease cannot complete the questionaire.
6. Patients refused the informed consent.
Evaluation of Chemotherapy Influence on Clinical and Biological Markers of Ovarian Reserve

The objective is to evaluate the influence of chemotherapy, either for auto-immune disease, either for carcinologic disease, on clinical and biological markers of ovarian reserve, for young patients, with normal reproductive functions.

The study will enrol patients between 18 and 35 years, treated with neoadjuvant or adjuvant chemotherapy for systemic lupus erythematosus (Group 1), breast cancer (Group 2) or Hodgkin disease (Group 3)to evaluate the clinical and biological markers of ovarian reserve. The follow-up will last 24 months for each patients with a visit before treatment, and at 3 months, 6 months, one year and two years after treatment.

During this period, we will collect pre and post treatment clinical data,and biological data and ultrasonographic data such as antral follicle count which is a marker of ovarian follicle reserve.These data were not observed in current practice.

Eligibility Criteria:
Inclusion Criteria:

* Women volunteers treated by chemotherapy,
* ≥ 18 and ≤ 35 years old
* Regular menstrual cyclicity, between 25 and 35 days
* Social security affiliation
* Signed informed consent

Exclusion Criteria:

* Women \< 18 and \> 35 years old
* Pregnancy
* Emergent treatment necessity
* No social security affiliation
* Virgin patients
Antimicrobial Susceptibility Testing Guided Antibiotic Selection Strategies in Salvage Helicobacter Pylori Treatment

Helicobacter pylori (H. pylori), which infects about 50% of the global population, has been recognized as a main risk factor of multiple gastric pathologies, especially non-cardiac gastric cancer. Strongly evidence supports that H. pylori eradication is an effective approach to reduce the incidence of those pathologies.


Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients who are 18-70 years old with persistent H. pylori infection after first or second line treatment attempts.

Exclusion Criteria:

* Enable to undergo upper endoscopy;
* Patients with gastrectomy, acute GI bleeding and advanced gastric cancer;
* Known or suspected allergy to study medications;
* Taking bismuth and antibiotics in the previous four weeks, or taking proton pump inhibitor and H2-receptor blockers in the previous two weeks;
* Currently pregnant or lactating
* Inability to provide informed consent and other situations that could interfere with the examination or therapeutic protocol.
DMSO for Prevention of Capsular Contraction in Alloplastic Breast Reconstruction

Capsular contraction is the one of the most common complications of both esthetic and reconstructive breast surgery, with high incidence after radiotherapy. The mechanism of the contraction is unclear, but is believed to be similar to the formation of hypertrophic scarring.

Dimethyl sulfoxide (DMSO) has demonstrated its use as an anti-inflammatory, anti-proliferative, and antibacterial agent.

The aim of this study is to test the effect of DMSO on the incidence and severity if capsular contracture after breast alloplastic reconstruction in irradiated patients.

We conduct a prospective randomized-control single-surgeon study in the tertiary academic Rabin Medical Center.

110 female candidates for mastectomy, radiotherapy and immediate two-stage reconstruction will be included. They will be divided into two groups: the DMSO treatment group, which will be treated according to our protocol, and the control group, that will be treated with the same protocol but with 0.9% saline instead.

Several measures will be taken, including: capsular contracture grading by two plastic surgeons, a VAS-score of breast pain, maximal capsular thickness (MCT) in sonography evaluation, and pathology examination of the capsule (biopsy will be taken during the second stage operation).

Rates and grades of capsular contracture evident clinically, radiologically and pathologically, will be evaluated and compared.


Eligibility Criteria:
Inclusion Criteria:

* female candidates for mastectomy, radiotherapy and immediate two-stage reconstruction

Exclusion Criteria:

* autologous reconstruction
* single-stage alloplastic reconstruction
* intake of steroids, anti-inflammatory, anti-coagulate or immunomodulatory medications on a regular basis
* low compliance to home treatment or follow-ups.
An Evaluation of a Family Counseling Intervention ("Tuko Pamoja") in Kenya: a Single Case Series Design

The purpose of this study is to evaluate a family counseling intervention, entitled "Tuko Pamoja" (Translation "We are Together" in Kiswahili). The intervention, delivered by lay counselors and through existing community social structures, is expected to improve family functioning and individual mental health among members. The sample includes highly distressed families with a child or adolescent (ages 8-17) exhibiting emotional or behavioral concerns; as such, particular emphasis is placed on adolescent-focused outcomes, including mental health and well-being.

The purpose of this study is to evaluate a family counseling intervention, entitled "Tuko Pamoja" (Translation "We are Together" in Kiswahili), using a single case series design.

The intervention, delivered by lay counselors and through existing community social structures, focuses on improving family relationships and mental health with content derived from evidence-based practices; these include solution-focused family therapy and cognitive behavioral strategies. It is components based, with modules delivered based on need. The content and structure has been adapted in both content and implementation model based on formative research in this context. Primary hypotheses include achieving improvements in outcomes related to:

1. Family functioning, including elements such as communication, emotional closeness, structure and organization, and satisfaction for the overall family; this also includes indicators of functioning at dyadic levels (i.e., parent-child and couples functioning)
2. Mental health of both children and caregivers, including positive well-being, with a particular emphasis on outcomes for children and adolescents.

The investigators also hypothesize feasibility and acceptability based on a previous evaluation of the program and are analyzing community-sourced practices used by lay counselors. Investigators hypothesize that they are integrating locally-grounded strategies that may influence the delivery or outcomes of the intervention.

The study will follow a single case series design with a sample size of 8 families, including up to 3 caregivers per family (who hold primary responsibility for the child whether biological or non-biological) and a target child identified through caregiver-report of the child about whom they are most concerned. This design will allow for tracking changes in outcome variables over time and for linking clinical changes to session content and delivery strategies.

Eligibility Criteria:
Inclusion Criteria:

* Family with self-reported elevated distress (e.g., high levels of conflict) that also has a child/adolescent (ages 8-17) with caregiver-reported emotional or behavioral concerns

Exclusion Criteria:

* Families without reported distress and/or without reported adolescent distress.
* Families with children older than 17 or younger than 8 years of age.
* Families in which primary caregivers or children are living too far outside of the community to participate in treatment.
The Impact of Supermicrosurgery Intervention on Patients with Lower Extremity Lymphedema Using Groin-Only Approach Lymphaticovenous Anastomosis

This study employs a propensity score-matched analysis to compare the treatment outcomes, focusing on percentage volume reduction between the conventional multi-incision lymphaticovenous anastomosis (LVA) technique and the novel single groin incision LVA technique in patients with unilateral lower extremity lymphoedema.

Lymphaticovenous anastomosis (LVA), a surgical technique that connects lymphatic vessels (LVs) to adjacent veins, has demonstrated efficacy in alleviating lymphedema by enabling the drainage of stagnant lymphatic fluid.

Conventional LVA treatment for lower extremity lymphoedema (LEL) has favored distal, multiple incisions in the lower leg due to the denser and more superficial distribution of LVs and recipient veins in the distal regions.

Based on the recent advancement in the understaning of lymphosomes and the role of antegrade lymph flow, a shift to more proximal LVA around the groin region for LEL could be theoretically advantagous, but its clinical efficacy compared to conventional distal LVA remains underexplored.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with lymphatic-related diseases to the lower extremity
* Patients who is undergoing LVA for unilateral lower-limb lymphedema.

Exclusion Criteria:

* Primary lymphedema
* Bilateral lower limb lymphedema
* History of previous treatment for lymphedema (LVA, vascularized lymph node transfer (VLNT), liposuction, or excisional therapy such as the Charles procedure) - Those that were lost to follow-up.
* Patients who recieved both LVA to the groin site and non-groin site.
The Effect of a Dietary Supplement Rich in Nitric Oxide in Patients Diagnosed With Primary Ciliary Dyskinesia.

The purpose of this study is to determine the effect of a dietary supplement rich in nitric oxide (NO) on nasal nitric oxide and fractional exhaled nitric oxide (FeNO),on ciliary beat frequency assessed by high-speed digital video microscopy and on lung function assessed by spirometry in normal patients and patients with Primary ciliary dyskinesia (PCD).


Eligibility Criteria:
Inclusion Criteria:

Experimental group:

* PCD patients

Control Group:

* patients with no known chronic lung disease
* 18 years to 99 years

Exclusion Criteria(both PCD patients and control group):

* any other pulmonary co-morbidities and diseases entities like cystic fibrosis, nasal sinus surgery, nasal sinus hypoplasia/aplasia, deviated nasal septum, nasal polyps and with upper respiratory tract infection
* patients allergic to beet
* a known prolonged bleeding disorder.
Pro-Change Smoking Cessation Intervention

The purpose of this study is to determine whether a behavioral economics solution impacts smoking cessation program engagement and quit rates.

The behavioral economics solution is a weekly regret contest in which participants can win or miss out on money based on their behavior.

Eligibility Criteria:
Inclusion Criteria:

* Be current tobacco users (specifically smokers)
* Be 18 years old or over

Exclusion Criteria:

* Pregnant women
Combination Chemotherapy in Treating Patients With Advanced Solid Tumors

Phase I trial to study the effectiveness of combining alvocidib, irinotecan hydrochloride, and cisplatin in treating patients who have advanced solid tumors. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

OBJECTIVES:

I. Determine the maximum tolerated dose of flavopiridol (alvocidib), irinotecan (irinotecan hydrochloride), and cisplatin in patients with advanced solid tumors.

II. Determine the clinical pharmacokinetics of this regimen in these patients. III. Determine, preliminarily, the therapeutic activity of this regimen in these patients.

OUTLINE: This is a dose-escalation study.

Patients are stratified according to the number of prior treatment regimens (0 or 1 vs more than 1). Patients receive irinotecan hydrochloride intravenously (IV) over 30 minutes followed immediately by cisplatin IV over 30 minutes followed 7 hours later by alvocidib IV over 1-4.5 hours weekly for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of cisplatin, alvocidib, and irinotecan hydrochloride until the maximum tolerated dose (MTD) of each is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, 12 additional patients are treated at the recommended phase II dose.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed locally advanced or metastatic solid tumor that is refractory to standard therapy or for which no standard therapy exists
* Evaluable disease
* No previously untreated CNS metastasis
* No primary CNS tumors
* Performance status - Karnofsky 60-100%
* Performance status - ECOG 0-2
* Not specified
* WBC at least 3,000/mm\^3
* Neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
* Bilirubin no greater than 2.0 mg/dL
* AST and ALT no greater than 3 times upper limit of normal (ULN) (5 times ULN if liver metastases are present)
* Creatinine no greater than 1.5 mg/dL
* Creatinine clearance at least 60 mL/min
* No cardiac arrhythmia
* No congestive heart failure
* No myocardial infarction within the past 6 months
* HIV negative
* No neuropathy grade 2 or greater
* No serious or uncontrolled infection
* No other medical condition or reason that would preclude study participation
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for at least 2 months after study participation
* At least 4 weeks since prior immunotherapy
* At least 1 week since prior irinotecan and cisplatin alone
* At least 4 weeks since other prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
* Not specified
* At least 4 weeks since prior radiotherapy
* Not specified
* Recovered from all prior therapy
* No concurrent vitamins, antioxidants, or herbal supplements except a daily multivitamin
* No other concurrent investigational drugs
Biological Factors in Predicting Response to Treatment in Patients With Esophageal Cancer or Rectal Cancer

RATIONALE: Studying samples of tumor tissue and blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.

PURPOSE: This clinical trial is studying how well biological factors work in predicting response to treatment in patients with esophageal cancer or rectal cancer.

OBJECTIVES:

Primary

* Analyze various biological factors that can be used as markers to predict response to treatment and correlate with the signaling pathway of EGFR.

Secondary

* Establish a tissue bank to store information about the response to treatment and survival.

OUTLINE: Patients undergo endoscopy, 11 biopsies of tumor tissue, and 3 biopsies of healthy mucosa. Blood samples are also collected. Samples are analyzed for the expression of 4 receptors in the EGFR family, polymorphisms at intron 1 of the EGFR gene, and gene mutations in downstream signaling pathways.

After surgery, patients are followed every 3 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed adenocarcinoma or squamous cell carcinoma of the esophagus or rectum
* Planning to receive neoadjuvant treatment, including radiotherapy or chemoradiotherapy

PATIENT CHARACTERISTICS:

* Not pregnant or nursing
* No blood disorder
* Not deprived of freedom or protected by law

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
The Effect of Covid-19 Process

Objective: The purpose of this study was to investigate the effect of the Covid-19 process on time management, participation, and leisure time activity.

Methods: 531 individuals aged between 18-65 were included in the study. The individuals were evaluated with the Assessment Of Time Management Skills (ATMS) in terms of time management, with the Social Isolation Questionnaire (SIQ) in terms of participation, and with the Interest Checklist (IC) in terms of leisure time activities.


Eligibility Criteria:
Inclusion Criteria:

* aged between 18-65
* lived the Covid-19 process in Turkey

Exclusion Criteria:

* did not complete the scales
* did not live in Turkey
Emergent Expanded Access for ahSC Augmentation of Nerve Autografts After Severe Peripheral Nerve Injury.

The primary purpose of this research study is to determine the safety of injecting ones own Schwann cells to augment sural nerve autografts after a severe, non-lacerating injury to the sciatic nerve has occurred.

The secondary purpose of this research project is to evaluate whether transplanted Schwann cells can enhance recovery of sensory and motor function. Emergency expanded access for a single patient was granted, as the patient was an ideal candidate for sural nerve repair augmented by autologous Schwann cells which could be harvested from a relatively small segment of sensory nerve. The cells were expanded using cell culture techniques and placed along with the sural nerve grafts wrapped by an FDA approved collagen matrix (Duragen). This study is being conducted at the Jackson Memorial and the University of Miami health systems. As a research subject the patient will be in this study for a total of 5 years from the date receiving Schwann cell transplant augmentation of sural nerve autografts.

Eligibility Criteria:
Single patient with severe sciatic nerve injury enrolled under emergency request
Impact of Genotyping P450 2C19 on Hospitalization Period

Monocentric study with the objective to evaluate the impact of genotyping CYP2C19 on the hospitalization period. The genotyping will permit to adapt at best the Voriconazole posology.

The main objective of this multi-center study is to evaluate the impact of dose adjustment of Voriconazole after CYP2C19 genotyping at the start of treatment, on the length of hospital stay.

Thus, a new strategy will be proposed as part of this project and will be compared to the reference strategy:

The New strategy: genotyping of CYP2C19 in any patient receiving treatment with Voriconazole in order to better adapt the treatment regimen as quickly as possible (increase of the dosage of Voriconazole in high-speed metabolisers or use of another antifungal, decreased dosage in poor metabolisers).

The Reference strategy: pharmacological therapeutic monitoring of Voriconazole allowing an adaptation of the Voriconazole dosage based on the residual concentration measured once steady state has been reached (5 elimination half-lives).

Multicenter, randomized study comparing two strategies of Voriconazole adaptation according to whether or not genotyping of CYP2C19 is performed as soon as Voriconazole is started.

Thus, the new strategy tested in this project and compared to the reference strategy (adaptation of Voriconazole dosage depending on the residual concentration), will be a genotyping of CYP2C19 in any patient receiving a treatment based on Voriconazole in order to better adapt the treatment regimen as quickly as possible (increase in the dosage of Voriconazole or use of another antifungal agent in ultra-rapid metabolisers, decrease in dosage in poor metabolisers).

Eligibility Criteria:
Inclusion Criteria:

* Patient with Voriconazole treatment
* Man or woman
* With social security number

Exclusion Criteria:

* Patient or parent of patient who refuse to accept inform consent form
* All patient under protection of adults
Turkish Version of Revised Neurophysiology of Pain Questionnaire

The Neurophysiology of Pain Questionnaire was first developed in English to test whether healthcare staff and patients could exactly understand pain neurophysiology. This questionnaire which contains 19 items was developed from the exam questions of students interested in post-graduate pain medicine. Catley et al. (2013) investigated the psychometric properties of the modified Neurophysiology of Pain Questionnaire with a few word differences from the original version by conducting a rash analysis on 300 patients with chronic spinal pain. Acceptable internal consistency and test-retest reliability of the questionnaire were recorded. However, it was stated that 7 items negatively affect psychometric properties of the questionnaire. As a result, the author concluded that the questionnaire had sufficient psychometric properties for use in chronic spinal pain subjects, but further studies were needed. The Neurophysiology of Pain Questionnaire was used to measure a knowledge about pain in different studies. The validity and reliability studies of the Dutch, French and Brazlian Portuguese versions of the Neurophysiology of Pain Questionnaire were conducted in the literature. The aim of our study was to translate the Revised Neurophysiology of Pain Questionnaire into Turkish language and to investigate its psychometric properties.


Eligibility Criteria:
Inclusion Criteria:

* Patients with spinal pain lasting more than three months
* Patients who older than 18 years of age
* Patients who can understand and read Turkish.

Exclusion Criteria:

* Patients with specific spinal pain such as trauma, fracture, infection, inflammatory disease and tumor
* Patients who have undergone spinal surgery in the last 3 months
* Patients who have received pain neurophysiology education in the last year.
Probiotics as a Prophylaxis to Prevent Clinical Manifestations of Oral Candidosis in Patients With Sjogren's Syndrome

Sjogren's syndrome is an autoimmune chronic disease. It has two forms Primary Sjogren's syndrome charactrized by dry eyes and dry mouth. Secondary Sjogren's syndrome characterized by rheumatoid diseases as rheumatoid arthritis, scleroderma and lupus erythematosus. SS patients are most liable to oral candidiasis , so they need prophylaxis aganist oral candidiasis. Probiotic bacteria are live microorganisms that when administered in adequate amounts confer benefits to health.Probiotics are commonly used as a prophylaxis aganist oral candidosis.


Eligibility Criteria:
Inclusion Criteria:

* primary or scondary Sjogren's syndrome

Exclusion Criteria:

* allergy to milk derivatives previous intake of antifungals