cyrilzakka/clinical-trials huggingface dataset:
Streptococcus Salivarius K12 for Prevention and Treatment of Oral Mucositis in Patients Undergoing Radiotherapy

To evaluate the efficacy and safety of Streptococcus salivarius K12 for prevention and treatment of oral mucositis in patients undergoing radiotherapy for malignant head and neck tumors.

The goal of this clinical trial is to evaluate the efficacy and safety of Streptococcus salivarius K12 in reducing the incidence, duration, and severity of severe oral mucositis (SOM). The main questions it aims to answer are whether Streptococcus salivarius K12 can effectively prevent and treat radiation-induced oral mucositis and whether it will cause adverse events in patients undergoing radiotherapy.

Participants will be instructed to suck a Streptococcus salivarius K12 or placebo lozenge three times daily from the beginning to the end of RT. After using the lozenges, the patients should avoid eating, drinking and conducting any oral hygiene activities for at least 1 hour.

Researchers will compare Streptococcus salivarius K12 group and placebo group to see if oral probiotic are beneficial in preventing and treating oral mucositis in patients undergoing radiotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Patients with non-metastatic head and neck malignant tumor diagnosed by histopathology;
* Aged 18 to 80 years;
* Systemic functional status Eastern Cooperative Oncology Group (ECOG) (Appendix 1) rating ≤2;
* Receiving definitive RT or postoperative adjuvant RT at a dose of 60-72Gy with/without concurrent chemotherapy;
* Sign the informed consent

Exclusion Criteria:

* Patients with known allergy to probiotic or severe allergic constitution;
* Using antibiotics/antifungal drugs within 1 month or using antimicrobial mouthwash within 1 week before the study;
* Poor oral hygiene and/or severe periodontal diseases;
* Any previous RT to the head and neck region;
* Deemed unsuitable for the study by the investigators (concomitant with any other severe diseases).
Schnederian Membrane Elevation and Augmentation With Deproteinized Bovine Bone [Tutu-gen Bone] Versus Graft Less Tenting Technique With Simultaneous Implant Placement

30 recruited patients indicated for sinus membrane elevation with simultaneous implant placement. patients are divided into 2 groups each group contain 15 patients, one group assigned for placement of bovine bone graft after membrane elevation and insertion of the implants while the other group assigned for graft-less tenting technique after membrane elevation and insertion of the implant.

On the 2 groups a mucoperiosteal flap is elvated then a lateral wondow is created then sinus membrane is elevated then the implants are placed, in the control group deproteinized bovine bone graft substitute is placed in the sinus for augmentation while in the study group no bone graft is added inside the sinus( graftless tenting technique)

Eligibility Criteria:
Inclusion Criteria:

* patients with atrophic maxilla and pneumatization of the maxillary sinus with residual bone height at least 5mm as per MISCH criteria.
* both sexes.

Exclusion Criteria:

* sinus pathology
* heavy smokers(more than 20 cigarettes per day.
* patients with systemic disease that may affect normal healing.
Feasibility Study of Interval Compressed Regimen Using Four-drugs for Osteosarcoma

The aim of the study is to test the feasibility of four-drug, interval-compressed regimen in osteosarcoma.

Primary objective is to explore the toxicity and mortality related to treatment. Secondary objectives are to examine tumor necrosis rates after neoadjuvant chemotherapy, and to evaluate the usefulness of circulating cell-free DNA, survivin, or transforming growth factor-beta1 levels as well as programmed cell death ligand 1 expression in tumor specimen as a predictive or prognostic biomarker in osteosarcoma patients.

In this study, the investigators will investigate the feasibility of interval compressed regimen using four-drugs in newly-diagnosed osteosarcoma patients. Four drugs will be adriamycin, high-dose methotrexate, cisplatin, ifosfamide. All these drugs will be given preoperatively in an interval-compressed schedule, but postoperatively at a regular interval. Neoadjuvant therapy will be composed of two courses, and adjuvant therapy of two or three courses depending on necrosis rates following neoadjuvant therapy.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed osteosarcoma patients under age 40 years.

Exclusion Criteria:

* Patients who don't meet the organ function criteria as follows;

  1. renal function : CCr or GFR or eGFR ≥ 70 mL/min/1.73 m2
  2. liver function : AST/ALT ≤ 5 x upper limit, total bilirubin ≤ 1.5 x upper limit of normal for age
  3. cardiac function : shortening fraction ≥ 24% or ejection fraction ≥ 50% (Echo)
  4. lung function : No dyspnea on rest, If dyspnea exists, SpO2 95% or more in room air by pulse oximetry,
  5. hematologic : ANC ≥ 750/uL and platelet ≥ 75,000/uL
Feasibility and Acceptability of Use of Daily Oral Rinse in Pregnant Women in Rural Nepal

In Nepal, investigators are conducting a cohort study to estimate the relationship between signs of periodontal disease in pregnant women and preterm delivery. Within that cohort study, investigators plan to conduct an individually randomized trial of the acceptability and effect chlorhexidine, cetylpyridinium chloride, and salt water oral rinses on gingival crevicular fluid and plaque during pregnancy. Women for this pilot trial will be chosen from a subset of the area currently engaged in the larger cohort study, to simplify logistics. The pilot trial will have four arms (three oral rinse arms, and one control group).

* Arm 1: Twice daily oral rinse containing chlorhexidine 0.12% w/v (n=25 women with periodontitis
* Arm 2: Twice daily oral rinse with cetylpyridinium chloride (n=50; 25 women with/without periodontitis)
* Arm 3: Twice daily oral rinse with salt and water (n=50: 25 women with/without periodontitis)
* Arm 4: No oral rinse (n=50)

To select and enroll these 175 participants, data collectors will use the information they collected during an oral health clinical examination conducted at the time of enrollment into the broader cohort study; this information will be used to classify women by signs of periodontitis.

Those selected through this above process will be read an additional consent form; those agreeing to participate will be provided with a supply of their assigned rinse (and instructions on its use and handling/storage), or no rinse. Those in the three rinse groups will be asked to use the provided rinse twice per day after brushing and to save the empty bottles for collection by the health care worker. At the end of this first visit, women will additionally provide a venous blood sample to measure systemic inflammation markers and fluoride.

Women receiving the rinse will be visited by study workers periodically to provide more oral rinse and check on their adherence to the rinse. All 175 women will be visited after 12 weeks to undergo a second oral health clinical examination and provide a second set of gingival crevicular fluid and plaque samples, to allow for evaluation of the effect of each of the oral rinses as compared to the normal physiological changes in gingival inflammation and biofilm composition during the course of pregnancy.

At this final visit, the women in the three rinse arms will also answer a short questionnaire to gather feedback on acceptability and adherence to the oral rinse.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant
* \<26 weeks gestation at enrollment
* Enrolled in the broader cohort study

Exclusion Criteria:

* Already previously enrolled
* Not Pregnant
A Study of Infliximab in the Treatment of Chinese Children With Crohn's Disease

The main purpose of this study is to record the use of Infliximab (IFX) in the treatment of Chinese children with Crohn's disease (CD) in routine clinical practice and to summarize the clinical efficacy and safety of IFX in the treatment of pediatric CD.


Eligibility Criteria:
Inclusion Criteria:

* Must have a confirmed diagnosis of Crohn's disease
* Must sign, and their legal guardians/legally-acceptable representative where applicable must sign, a participation agreement/ICF allowing data collection and source data verification in accordance with local requirements
* First-time received IFX treatment

Exclusion Criteria:

* History of medical contraindications for Infliximab (IFX), example. serious infections, active tuberculosis (TB), lymphoma and other malignancies, moderate to severe heart failure, hypersensitivity to inactive components of the product or to any murine proteins
* Previous exposure to Infliximab or any other biologics
* Received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 90 days before the start of the study or the first data collection time point
* Currently enrolled in an investigational study
* Have other Crohn's-like disease that are associated with mono-genetic immune disorders
Risedronate for the Prevention of Osteoporosis in People With Spinal Cord Injury.

The purpose of this study is to find out if Risedronate works to prevent osteoporosis after spinal cord injury.


Eligibility Criteria:
Inclusion Criteria:

* Traumatic spinal cord injury less than 100 days.
* Must be able to swallow tablets and sit upright.

Exclusion Criteria:

* Bilateral knee flexion contractures.
* Pregnant, lactating or post-menopausal females.
* Paget's disease, osteomalacia, steroid induced bone loss, untreated thyroid disease, iritis, uveitis, pancreatitis, gastritis, peptic ulcer or cholecystitis.
* Treatment in the last year with calcitonin, fluoride or anabolic steroid.
* Concurrent treatment with prednisone.
EMG-Controlled Game to Retrain Upper Extremity Muscle Activation Patterns Following Stroke

The purpose of this study is to develop and test if upper limb task practice and muscle activity training improve upper limb function in stroke survivors. Participants will be asked to come to the laboratory 23 times (approximately 3 times a week) over 2.5 months to receive upper limb task practice, muscle activity training, and/or upper extremity functional assessments.

The purpose of this study is to develop and test if upper limb task practice and muscle activity training improve upper limb function in stroke survivors. Participants will be asked to come to the laboratory 23 times (approximately 3 times a week) over 2.5 months to receive upper limb task practice, muscle activity training, and/or upper extremity functional assessments.

Eligibility Criteria:
Inclusion Criteria:

* 18+ years old
* Stroke more than 6 months ago
* Moderate unilateral upper limb impairment
* Cognitive ability to participate in the study procedure
* Ability to see the full computer screen

Exclusion Criteria:

* Concurrent upper limb rehabilitation
* Inability to voluntarily contract muscles of at least 2 upper limb muscle groups, prohibiting participation in training
* Change in spasticity medication or botulinum toxin injection in the upper limb within 3 months prior to or during enrollment
* Total sensory loss
* Comorbidity (e.g., orthopaedic or premorbid neurologic condition) that limit upper limb movement and/or participation in the intervention
* Language barrier or cognitive impairment that precludes providing consent
Intraoperative Imaging of Breast Cancer With Indocyanine Green

According to the World Health Organization, breast cancer is the most common cancer in women, and is responsible for 686,000 new cases every year. The WHO also posit that nearly 420,000 women perished from the disease in 2002. Surgery remains the best option for patients presenting with operable Stage I, II or III cancers. Breast conservation surgery has been shown to be as efficacious as mastectomy. About 60-70% of these women with operable breast cancer are breast conservation candidates. However, the need to achieve negative tumor margins often requires a second operation (re-excision) in up to 70% of the women having lumpectomy surgery. Currently, tumor margins assessment in the operating room is often assessed grossly by palpation. The ability to evaluate tumor margin using our proposed intraoperative imaging technique may provide the surgeon with an alternative, and hopefully, more sensitive method to assess tumor margins which may decrease re-excision and the morbidity associated with additional surgery, and, perhaps, lower the risk of local regional recurrence.


Eligibility Criteria:
Inclusion Criteria:

1. Adult patients over 18 years of age
2. Women with newly diagnosed, operable invasive ductal carcinoma, invasive lobular carcinoma or ductal carcinoma who are deemed breast conservation surgery candidates (i.e. lumpectomy +/- sentinel node biopsy).
3. Breast cancer needs to be unifocal as determined by clinical parameters, e.g. by palpation or by breast imaging findings including mammogram, US and/or breast MRI. Multifocal disease, i.e. cancer confined to one quadrant, is eligible if patients are deemed breast conservation candidates.
4. Subject capable of giving informed consent and participating in the process of consent.

Exclusion Criteria:

1. Newly diagnosed breast cancer patients who are not breast conservation candidates and those with multicentric breast cancer (breast cancer documented in multiple quadrants by breast imaging or exam)
2. Pregnant women as determined by urinary or serum beta human chorionic gonadotropin (hCG) within 72 hours of surgery
3. Subjects with a history of iodide allergies
4. At-risk patient populations

   1. Homeless patients
   2. Patients with drug or alcohol dependence
   3. Patients unable to participate in the consent process
Feelings About Exercise

This study seeks to investigate why some individuals exercise more than others by focusing on feelings related to exercise. This two part study first examines whether regular exercisers (n=30) and non-exercisers (n=30) differ in how a 30-minute moderate-intensity exercise bout makes them feel. All participants will walk on a treadmill for 30 minutes on two separate occasions and will be asked to report on how they feel before, during, and after exercise, how they anticipate that exercise will make them feel, and how they remembered feeling during exercise. In addition, after exercise session #2, non-exercisers will be randomized to: 1) a brief intervention focused on providing general information about the physical activity guidelines, or 2) a brief intervention which provides general information about physical activity guidelines, but also focuses on affective responses to physical activity. Non-exercisers will complete an identical, third exercise session approximately 1-week following this intervention. Further, all participants will receive a 12-week, Internet-delivered weight loss program following all exercise visits and physical activity will be assessed before and after the weight loss program.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-60 years
* BMI between 25.0 and \<40.0 kg/m2
* Either a 'Non-exerciser', defined as reporting exercising at a moderate-intensity for \<30 min/week over the past 6 months and a most recent typical week or an 'exerciser', defined as exercising for ≥150 min/week over the past 6 months and a most recent typical week.

Exclusion Criteria:

* Presence of any condition that would limit one's ability to exercise (e.g., orthopedic limitations)
* History of coronary artery disease (i.e., myocardial infarction or symptoms of angina), stroke, diabetes, or pulmonary disease (e.g., COPD or emphysema).
* Currently taking any medication that would alter heart rate (e.g., beta blocker)
* Women who are pregnant or nursing
* Uncontrolled hypertension (resting blood pressure ≥140/90 mmHg)
* Exercising \>30 min/week but \<150 min/week (i.e., neither 'non-exerciser' nor 'exerciser')
* Use of medications for weight loss, or current participation in another weight loss program
* Bariatric surgery
Effects of Low-Intensity Blood Flow Restriction Training in Normoxia and Hypoxia Conditions

One approach to significantly reducing resistance training intensity while maintaining effectiveness in muscle mass and strength development involves conducting training sessions under hypoxic conditions. This is likely due to heightened physiological responses. While sports science research indicates a substantial impact of hypoxic conditions on immediate increases in metabolic stress and augmented hormonal responses, recent findings suggest that the role of their influence on skeletal muscle adaptations post-resistance training under hypoxic conditions remains unknown. Additionally, there is a lack of reports on whether the type of hypoxia applied via blood flow restriction or chamber differentiates the increase in secretion of these catecholamines in both immediate and long-term aspects.


Eligibility Criteria:
Inclusion Criteria:

* Regularly physically active (at least 30 mins of structured exercise 3 times per week),
* Sea-level natives,
* Experienced in resistance training (at least one year of experience in regular resistance exercise)

Exclusion Criteria:

* presence of any medical risk factors to exercise and/or exposure to altitude
* presence of any medical condition that would make the protocol unreasonably hazardous for the participant
* smokers
Immune Biomarker Study for Salivary Gland Carcinoma

Aims of this study are analyses of tumor metabolome, tumor transcriptome and tumor proteome as well as of the immune infiltration, separated by histological entity. These data will subsequently be compared with the with the detailed immune status determined in the patient's peripheral blood and saliva using machine learning techniques, among others, to create a biomarker cluster for salivary gland tumors. These can be used in clinical routine.

In addition, the investigators would like to study a subset of patients from freshly resected tumor organoids from freshly resected tumor tissue according to already established methods in order to mechanistic investigations of prognostic parameters.


Eligibility Criteria:
Inclusion Criteria:

1. Observational group

   * Initial diagnosis of a primary salivary gland carcinoma in the head and neck region (no squamous cell carcinomas)
   * Specimen collection from the center of the tumor when the primary tumor is sufficiently large without that the pathological assessment is impaired
2. Control group 1

   * Initial diagnosis of a benign salivary gland tumor in the head and neck region
   * Specimen collection from the center of the tumor when the primary tumor is sufficiently large without that the pathological assessment is impaired
3. Control group 2

   * functional diseases of the nose or ear (patients with the indication for functional ear surgery and rhinoplasty)
   * Specimen collection with sufficiently large resectate during a functional nose surgery

for all groups:

* Willingness of patients to collect blood, saliva and stool and consent to the preservation of all samples for study purposes.
* Age ≥ 18 years
* sufficient cognitive ability of the patients to understand the purpose of the study and to understand the purpose of the study and agree to it

Exclusion Criteria:

* Distant metastasis at the time of diagnosis and simultaneous second cancers, i.e. at study inclusion
* Malignancy in the last 5 years regardless of location (except basal cell carcinoma or cis of the uterine cervix)
* Carcinomas for which specimen collection is not possible or likely without compromising the compromise the pathological evaluation
* Persistent drug or medication abuse
* Patients who are unable or unwilling to comply with protocol and to be treated
* Patients who are represented by a legal guardian
* Patients who are not suitable for participation in the study due to a language barrier
Study to Evaluate Product Duration of Use Experience With Alclometasone Dipropionate Cream

This is a multi-center, open-label study to evaluate whether participants follow the duration of use instructions for short-term use of alclometasone dipropionate in a population of participants with itchy skin conditions who would use OTC treatments for relief. The study population will be composed of two different cohorts: chronic condition sufferers (eczema or psoriasis) and participants who suffer from occasional itchy skin experiences (such as poison ivy, oak, sumac, insect bites, or skin irritations due to jewelry, cosmetics, detergents, or soaps) where an anti-itch medication would be used.

Approximately 313 participants who are currently suffering from an itchy skin condition caused by eczema or psoriasis or any occasional itchy skin experiences will be enrolled into the study to get 250 participants who complete the study (at least 100 to each of the cohorts). After evaluation of the study criteria, the site staff will dispense product and a diary card to the subject to use over the next 14 days. At the end of the 14 days, each participant will come to the research site to return the remaining product and undergo the study termination interview with the Concentrics nurse via telephone. The study will be conducted in approximately 15 research sites located throughout the United States (US).

Eligibility Criteria:
Inclusion Criteria:

* Age: At least 12 years of age.
* Condition: Currently experiencing itch associated with one of the following skin conditions:

  * psoriasis or eczema,
  * minor skin conditions such as those caused by poison ivy, oak, or sumac, insect bites, or use of cosmetics, soaps, detergents, or jewelry.
* Compliance: Subject or subject's parent or legal guardian understands and is willing, able and likely to comply with all study procedures and restrictions.
* Consent: Subject or subject's parent or legal guardian demonstrates ability to read and understand English and is willing to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form (and assent as appropriate).

Exclusion Criteria:

* Pregnancy: Women who are known to be pregnant (as self-reported) or who are intending to become pregnant over the duration of the study. Women of childbearing potential will be allowed to participate in the study so long as they are practicing a reliable method of contraception (e.g. hormonal birth control such as pill, patch, implant or injection; intrauterine device, double barrier methods, tubal ligation, vasectomized spouse or abstinence).
* Corticosteroid Use: Subject has used a corticosteroid treatment within two weeks of the screening visit at the start of the study.
* Breast-feeding: Women who are breastfeeding.
* Allergy/Intolerance: Known or suspected intolerance or hypersensitivity to alclometasone cream (or closely related compounds), or any of their stated ingredients.
* Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit at the start of the study.