cyrilzakka/clinical-trials huggingface dataset:
Gegen Qinlian Tang and Probiotics for Radiation Enteritis

The purpose of this clinical study is to evaluate whether Bifidobacterium Triple Viable Capsules, alone or in combination with Gegen Qinlian Decoction, can effectively prevent and treat acute radiation enteritis in patients undergoing abdominal or pelvic radiotherapy.

The study aims to answer the following question: Can probiotics, with or without the addition of herbal medicine, reduce the incidence and severity of radiation-induced intestinal injury and improve the quality of life for patients during and after radiotherapy?

A total of 60 patients with malignant tumors receiving abdominal or pelvic radiotherapy will be recruited and randomly assigned to one of three groups: a control group (no intervention), a probiotics-only group (Bifidobacterium Triple Viable Capsules, three capsules twice daily), and a combination therapy group (probiotics with modified Gegen Qinlian Decoction tailored to individual symptoms).

The primary outcome will be the incidence and severity of acute radiation enteritis, assessed using the RTOG/EORTC grading criteria (0-IV levels). Daily observations will be recorded during radiotherapy, with follow-up lasting three months after the completion of treatment.

This study seeks to provide evidence for the use of probiotics and herbal medicine as effective strategies to mitigate the side effects of radiotherapy and improve patient outcomes.


Eligibility Criteria:
Inclusion Criteria:1.Age:Participants aged 18 to 80 years.2.Diagnosis:

Patients diagnosed with malignant tumors confirmed by cytological or pathological examination.Patients scheduled for abdominal or pelvic radiotherapy based on treatment guidelines.3Cognitive and Communication Ability:Participants must have clear consciousness and normal cognitive abilities to communicate effectively.4.Consent:Participants must provide written informed consent and agree to participate in the study.

Family members must also provide consent if applicable.5.Willingness to Cooperate:Participants must be willing to comply with the study procedures and requirements.

Exclusion Criteria:1.History of Severe Intestinal Diseases:Patients with a history of severe intestinal diseases, including ischemic bowel disease, ulcerative colitis, Crohn's disease, or other chronic inflammatory bowel conditions.2.Recent Antibiotic Use:Patients who have received antibiotic treatment within the past 2 years.3.Severe Organ Dysfunction:Patients with severe liver or kidney dysfunction, as determined by clinical assessment or laboratory tests.4.Comorbidities and Other Major Diseases:

Patients with other serious illnesses that may interfere with the study protocol or compliance, including but not limited to cardiovascular, respiratory, or neurological diseases.5.Inability to Participate:Patients unable to cooperate with the study procedures due to physical or psychological reasons.Patients who are likely to withdraw midway through the study.6.Incomplete Medical Records or Refusal to Share Data:Patients who refuse to share their medical records or have incomplete medical documentation.
Use of Music in Reducing Pain During Outpatient Hysteroscopy in Primarily Infertile Patients

The aim of this study is to demonstrate the value of music in outpatient hysteroscopy on patients' level of pain and satisfaction in primarily infertile patients.


Eligibility Criteria:
Inclusion Criteria:

* women with primary infertility requiring a diagnostic hysteroscopy as a part of an infertility diagnosis workup

Exclusion Criteria:

* women with suspected pregnancy

heavy vaginal bleeding recent pelvic infection those who received analgesics prior to OH a concomitant neurologic disease that could affect the correct evaluation of pain
Studying Biomarkers as a Diagnostic Tool in Samples From Younger Patients With B-Cell Acute Lymphoblastic Leukemia

This clinical trial is studying biomarkers as a diagnostic tool in samples from younger patients with B-cell acute lymphoblastic leukemia. Finding specific biomarkers may help improve the treatment of patients with B-cell acute lymphoblastic leukemia

STUDY SUBTYPE: Ancillary/Correlative

OBSERVATIONAL STUDY MODEL: Case-only

TIME PERSPECTIVE: Retrospective

BIOSPECIMEN RETENTION: Samples with DNA

BIOSPECIMEN DESCRIPTION: Fresh and frozen bone marrow cells

STUDY POPULATION DESCRIPTION: Patients with B-cell acute lymphoblastic samples banked at the COG Cell Bank

SAMPLING METHOD: Non-probability sample

OBJECTIVES:

I. To determine whether we can identify individuals within a specific sub-group of pre-B acute lymphoblastic leukemia (ALL) patients that will eventually recur.

II. To identify replication-timing changes as a biomarker for further risk prediction.

III. To identify differences between patients of similar subtype, and choose candidate differences to analyze by methods that are compatible with frozen samples.

OUTLINE:

Archived cell samples are analyzed for replication timing by flow cytometry, microarray, and single-cell fluorescence in situ hybridization (FISH) assays. Replication-timing results among cases and controls are also analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Frozen viable cell samples from patients with B-cell acute lymphoblastic (ALL) of any outcome from the Children's Oncology Group (COG) ALL Cell Bank (Part 1)
* Freshand frozen cell samples from patients with B-cell ALL with known outcomes from the COG ALL Cell Bank (Part 2) meeting 1 of the following criteria:

  * Samples from patients who experienced an early recurrence within 36 months of diagnosis (cases)
  * Samples from patients who remain in prolonged remission (controls)
* No samples meeting either of the following criteria:

  * Very-high-risk features

    * Philadelphia chromosome positive
    * Hypodiploid
    * MLL (11q23) rearranged
  * Known favorable risk factors

    * Hyperdiploid
    * t(12;21) (ETV6/RUNX1)
Fluoride in Saliva After Use of Fluoride Toothpastes Followed by Fluoride Mouthrinses

This study will evaluate fluoride (F) bioavailability in saliva when using an over-the-counter mouthrinse of 226 ppm F, immediately after brushing with an over-the-counter toothpaste of 1,100 ppm F or a prescription toothpaste of 5,000 ppm F. The study population will include twenty individuals, over the age of 18 years-old, from both genders, with normal oral health conditions and salivary flow rate, no need of urgent dental needs, from the Ann Arbor, MI area. Participants will be recruited from the University of Michigan School of Dentistry, in Ann Arbor, MI. Using a crossover design, twenty participants will be rotating through 4 different combinations of fluoride toothpaste (over-the-counter or prescription concentration) and fluoride mouth rinse (yes or no), in a 2 x 2 factorial design. Treatments to be tested will be as followed: Group #1 will brush with 1,100 ppm F (over-the-counter) toothpaste; Group #2 will brush with 1,100 ppm F (over-the-counter) toothpaste and rinse with over-the-counter 226 ppm F mouthrinse; Group #3 will brush with 5,000 ppm F (prescription) toothpaste; Group #4 will brush with 5,000 ppm F (prescription) toothpaste and rinse with over-the-counter 226 ppm F mouthrinse.


Eligibility Criteria:
Inclusion Criteria:

* Sign informed consent form
* Participant understands and agrees to comply with the study protocol, and confirms availability for the entire duration of the study
* 18 years of age or older
* Good general health
* Good oral health, with no urgent treatment needs
* Normal salivary flow rate

Exclusion Criteria:

* Fail to understand or to agree to follow the study protocol
* Reduced salivary flow rate
* Poor general or oral health conditions
Enabling Independent Living by Expanding Access to Home-Based Pulmonary Rehabilitation

The purpose of this study is to test an existing home-based pulmonary rehab program with the addition of video chat and a capability of a Spanish version.

The purpose of this research is to test video chat on a computer tablet that is used for Pulmonary Rehabilitation. We are interested in learning patients' thoughts on how easy or difficult video chat is to use and the translation to Spanish and the feed back from Spanish speaking patients .

Eligibility Criteria:
Inclusion Criteria:

* Patients must be ≥ 40 years old.
* Patients mist have a diagnosis of GOLD stage II, III, or IV COPD documented by pulmonary function testing.
* Patients must be a current or previous smoker with at least 10 pack-years of cigarette smoking.

Additional Inclusion Criteria to test Spanish version of system:

* Be a native Spanish speaker.

Exclusion Criteria:

* Patients with a high likelihood of being lost to follow-up or contact (patients with active chemical dependency).
* Patients planning to move out of the state or who are not living in the healthcare area.
* Patients with an inability to provide good data or follow commands (patients who are disoriented, have a severe neurologic or psychiatric condition).
Early Therapy of Pulmonary Arterial Hypertension

Exercise-induced increase of the pulmonary arterial pressure may be an early sign of pulmonary arterial hypertension. It has been shown that patients with normal pulmonary arterial pressure at rest but elevated pulmonary arterial pressure during exercise have a decreased exercise-capacity and may have a worse prognosis compared to patients with normal pulmonary arterial pressure values at rest and during exercise. According to the currently used definition pulmonary hypertension can be diagnosed if the mean pulmonary arterial pressure is higher than 25mmHg at rest or 30mmHg during exercise. In this study patients with a risk for pulmonary arterial hypertension (connective tissue disease) and increased pulmonary arterial pressure values during exercise are receiving a therapy with a dual endothelin receptor antagonist - bosentan, a therapy established for pulmonary arterial hypertension. The therapy effect is than compared to the recorded changes before the introduction of this therapy.

Bosentan is an established therapy in pulmonary arterial hypertension, which may be diagnosed when the mean pulmonary arterial pressure is \>25mmHg at rest or \>30mmHg at exercise. Bosentan has shown efficacy, if mean pulmonary arterial pressure was elevated at rest. However, there are no data available of the effects of such a therapy, if the mean pulmonary arterial pressure is normal at rest but elevated during exercise. The purpose of this study is to provide additional data on this group of patients. Our hypothesis is that patients with exercise-induced pulmonary hypertension may show a gradual worsening of pulmonary hemodynamics and potentially a development of manifest pulmonary arterial hypertension (elevated resting pulmonary arterial pressure values) without treatment, while the introduction of Bosentan may improve hemodynamics and exercise capacity in this patient group.

Eligibility Criteria:
Inclusion Criteria:

* exercise-induced pulmonary hypertension
* systemic sclerosis

Exclusion Criteria:

* relevant pulmonary obstruction or restriction
* relevant left cardiac disease
* recent changes in medical therapy
* recent major operations
* recent major cardiovascular diseases
* inability to perform exercise
Characterization of Beta Cell Failure

The purpose of this study is to characterise beta cell function in subjects who despite taking part in a diabetes prevention program (life style intervention with diet and exercise) exhibit impaired glucose tolerance and beta cell dysfunction.

We have identified a subgroup of individuals with a good compliance to lifestyle intervention to prevent diabetes who lose body weight and increase insulin sensitivity, however they remain impaired glucose tolerant. These individuals show a deterioration in insulin secretory function.

We will identify a highly selected group of subjects with prediabetes that displays a large defect in insulin secretory function.We will study 50 individuals who display these characteristics and 50 subjects who do not display these characteristics. Their insulin secretion capacity in response to different secretagogues (glucose, GLP-1, arginine) will be studied. We expect to detect new pathophysiologic aspects that lead to beta cell failure particularly in this group.

Eligibility Criteria:
Inclusion Criteria:

* Impaired glucose tolerance
* BMI 16-40 kg/m²

Exclusion Criteria:

* chronic disease
* anemia
* therapy with insulin or cortisone
Relation Between Body Mass Index and Endometrial Thickness

Postmenopausal Bleeding (PMB) is defined as recurrent attacks of bleeding occurring in women after menopause one year at least after stoppage of cycles \[

Premalignant lesions and malignant lesions most commonly complex hyperplasia with atypia and carcinoma of the endometrium are present in 1/3 of patients evaluated for postmenopausal bleed-ing, and so investigations for cases of postmeno-pausal bleeding are mandatory

Eligibility Criteria:
Inclusion Criteria:

* menopausal women (defined as minimum of 1 year of amenorrhea after the age of 45 years if only the amenorrhea is not related to pregnancy, medication or disease),

Exclusion Criteria:

* Women with chronic diseases as diabetes mellitus, hypertension or hematological disorders, those received hormone replacement therapy, Tamoxifen or anticoagulant therapy and women with adnexal massed detected by TVUS or apparent causes of bleeding from cervix or vagina e.g. ulcer were excluded.
A Study of Tarceva (Erlotinib) in First Line in Patients With Locally Advanced or Metastatic Lung Adenocarcinoma With EGFR Mutations

This open-label, non-randomized, one-arm study will evaluate the safety and efficacy of Tarceva (erlotinib) as single-agent first-line treatment in patients with locally advanced or metastatic non-small cell lung cancer who show epidermal growth factor receptor (EGFR) activating mutations. Patients will receive Tarceva 150 mg orally daily until disease progression or unacceptable toxicity occurs.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Histologically or cytologically documented, inoperable, locally advanced, recurrent or metastatic (Stage IIIB or Stage IV) lung adenocarcinoma
* Non-small cell lung cancer with an EGFR activating mutation
* Patients must have evidence of disease, but measurable disease is not mandatory
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Adequate renal and liver function

Exclusion Criteria:

* Prior chemotherapy or other systemic anti-cancer treatment. Neoadjuvant/adjuvant chemotherapy is allowed if completed within 6 months prior to enrolment. Prior radiochemotherapy is allowed if completed more than 6 months before start of study treatment
* Prior therapy with systemic anti-tumour therapy with HER1/EGFR inhibitors
* Any other malignancies within 5 years, except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin carcinoma
* Brain metastasis or spinal cord compression not yet definitely treated with surgery and/or radiation
* Patients unable to take oral medication or requiring intravenous alimentation, with prior surgical procedures affecting absorption or active peptic ulcer disease
* Any significant ophthalmologic abnormality, especially those likely to increase the risk of corneal epithelial lesions; the use of contact lenses is not recommended during the study
* Pregnant or breast-feeding women
Evaluation of the Correlation Between Molecular Phenotype and Radiological Signature (by PET-scanner and MRI) of Incident WHO II and III Grade Gliomas.

From the medical records of a series of patients operated on for incident grade II and III glioma, the primary objective is to evaluate the correlation between the molecular profile of tumours and preoperative imaging data (by FDG and FDOPA PET-scan and multimodal MRI).

A retrospective monocentre study of medical data (clinical, histological, molecular and imaging) contained in the medical records of patients operated on for Grade II or III incident glioma.

Eligibility Criteria:
Inclusion Criteria:

* Subject 18 years of age or older, having been informed of the research
* Subject operated on with an incident glioma of grade II or III, histologically confirmed (WHO 2016 classification)
* Subject for which all preoperative imaging data is available (MRI, FDG and FDOPA PET-scan)
* Subject for which molecular data of the lesion are available

Exclusion Criteria:

* Subject having signified his opposition to the use of his medical data
* Subject under safeguard of justice, guardianship or trusteeship
* Subject with incomplete or missing part of the molecular and/or imaging data
Predicting Successful Outcome of Interdisciplinary Biopsychosocial Rehabilitation in Osteoarthritis

The goal of this prospective study is to identify variables that can predict whether an interdisciplinary biopsychosocial intervention for patients with osteoarthritis will be successful.

Using an observational design, patients admitted to this program during the 3-year period (2019-2021) will be included and data gathered during routine clinical practice at baseline and end of treatment of patients who gave informed consent, will be used.

With these data a prediction model will be build and internal validation with bootstrapping will be done.

Rationale: To predict the probability of a positive outcome of interdisciplinary biopsychosocial intervention in individual patients with osteoarthritis (OA), a prediction model is needed.

Research Question/Objective: The overall goal is to develop a clinical prediction model to facilitate decision making in interdisciplinary biopsychosocial rehabilitation in patients with OA. The model will predict the individual probability (in percentage) of a positive response to the treatment (treatment success).

Design: A retrospective cohort design. Setting: A Dutch rehabilitation facility. Participants: Patients with OA diagnosed by a medical specialist and consisting at least three months.

Intervention and procedures: The intervention of interest is interdisciplinary biopsychosocial rehabilitation. The procedures include the development of a clinical prediction model and assessment of its performance and internal validity.

Measurements: Candidate predictors will be carefully selected. The outcome of the model will be treatment success, defined by the change on the Pain Disability Index (PDI). The model will be built with data gathered as part of routine practice.

Expected outcome of the research: The deliverable will be a clinical predication model, which can be used in follow-up research.

Eligibility Criteria:
Inclusion Criteria:

* Chronic musculoskeletal pain \> 3 months and osteoarthritis
* Large personal and social dysfunction
* Interplay of biological, social and psychological factors maintaining pain and/or disability

Exclusion criteria:

* Inability to actively participate in treatment (insufficient motivation, limited Dutch language skills, environmental factors, other pending treatments)
* Disagreement between patient and care providers on content of treatment
* Pending legal procedures that hinder full cooperation
Study of TS-1 as 2nd Line Treatment in Patients With Advanced Metastatic Breast Cancer

The purpose of this study is to assess the effectiveness and safety profile of Aiyi®(Tegafur Gimeracil Oteracil Potassium Capsule, TS-1) as a second line therapy in Chinese female patients with advanced metastatic breast cancer.

Tegafur Gimeracil Oteracil Potassium Capsule is a novel oral derivative of the 5-fluorouracil(5-FU) prodrug tegafur combined with two modulators. Recent clinical trial has reported the promising effect of Tegafur Gimeracil Oteracil Potassium Capsule in metastatic breast cancer. The innovative drug, S-1, has obtained the approval of treatment of advanced breast cancer in Japan, meanwhile, Generic drug is only approved for the indication of gastric cancer in China mainland by Chinese authority, SFDA, and no Chinese clinical study data of TS-1 in breast cancer so far.

Eligibility Criteria:
Inclusion Criteria:

* Age: 18-75 years old female.
* ECOG status: 0-2.
* Life expectancy of ≥ 3 months.
* Histologic or cytologic diagnosis of breast cancer.
* Progression after receiving one standard prior chemotherapy regimen for recurrent or metastatic lesion except an endocrine regimen.
* At least one measurable lesion of \>=2 cm (\>=1 cm on spiral CT scan)according to RECIST (v1.1).
* Adequate organ functions:

  * Hematopoietic: Hemoglobin ≥90g/L, Absolute neutrophil count ≥1.5×10\^9/L, Platelet count ≥80×10\^9/L.
  * Biochemistry: TBil ≤1.5 times upper limit of normal (ULN), AST and ALT ≤2.5× ULN(≤5x ULN if due to liver metastases), Creatinine ≤1.0×ULN and Creatinine clearance \>50 ml/min.
* Women with children potential must have negative pregnancy tests 7 days prior to enrollment and be willing to practice acceptable methods of birth control during the study and 8 weeks after last drug administered.
* Ability to take oral medication .
* Signed informed consent.

Exclusion Criteria:

* Pregnancy or lactation or no effective contraception in fertile patients.
* Prior treatment with 5-FU or drugs of same class(excluding patients that relapsed more than one year after adjuvant therapy).
* Less than 4 weeks since prior investigational agents.
* conditions impacting oral drug taking or absorption (e.g. inability to swallow, gastrointestinal resection, chronic diarrhea, intestinal obstruction).
* Organ invasion with rapid progression(e.g. lesions exceeding half of Liver or Lung).
* CNS or psychiatric disorders.
* Allergic to 5-FU.
* Only with bone metastases and no measurable lesions.
* Clinically significant heart diseases (e.g.congestive heart failure, ventricular arrhythmia, myocardial infarction) before enrollment.
* Serious peptic ulcer disease or digestive disorders.
* Bone marrow (Hemoglobin \<90g/dl, ANC \<1.5×10\^9/L, Platelet count \<75×10\^9/L).
* Renal function disorder (Creatinine \>1.0×ULN).
* Liver function disorder (TBil \>1.5×ULN).
* Uncontrolled brain metastases.
* Noncompliance with the study protocol.