cyrilzakka/clinical-trials huggingface dataset:
5-element Music Therapy on Patients With Breast Cancer

In this study, we observed the clinical effect of using music therapy of TCM to improve the status of liver depression in patients with postoperative breast cancer patients, Second we want to explore the efficacy and advantages of traditional Chinese medicine in patients with postoperative breast cancer, and to reveal the clinical use of the efficacy and superiority.

The study is a prospective controlled trial. Sixty-four patients were divided randomly into two groups. Patients were randomly divided into the treatment group and the control group, namely, the music treatment group and the health education group. The treatment group was given at least 30 minutes of individual music therapy and group music therapy every 3 weeks. Instead, the control group was given every 3 weeks of health education preach. It will take 12 weeks for treatment and observation. The efficacy was evaluated by observing the beginning and end of the trial of the Self-Rating Anxiety Scale score, the Self-Rating Depression Scale score, and the Breast Cancer Patients' Quality of Life Scale. At the end of the treatment, we take software packages SPSS 20.0 for management and statistical analysis.

Eligibility Criteria:
Inclusion Criteria:

* the diagnosis of breast cancer in clinical stage (Ⅰ, Ⅱ, Ⅲ) and postoperative breast cancer during one month;
* All participants had to have clinical depression and stagnation of liver qi;
* age 27-66;
* participants are conscious and willing to be followed up during the treatment.

Exclusion Criteria:

* Metastasis of breast cancer or serious complications;
* Patients with major depressive disorder;
* The past medical history of mental disorders;
* The primary diseases including liver, kidney, cerebrovascular, cardiovascular and hematopoietic system diseases;
* Participating in another clinical study or undergoing another intervention;
* Patients with hearing loss.
Repeatability of Positron Emission Tomography (TEP) With fluorométhyl-(18F)-diméthyl-2-hydroxyéthyl-ammonium

Monocentric study. Objective : Determination of the repeatability of fluorocholine PET/CT in prostate cancer

A second PET/CT with fluorocholine is performed within 2 weeks after a first examination performed in patient referred for an initial prostate cancer or a biological suspicion of relapse.

Eligibility Criteria:
Inclusion criteria :

* biological suspicion of relapse of prostate cancer or initial staging of prostate cancer
* positive PET/CT with fluororocholine

Exclusion criteria :

-none
Training Given to Caregivers of Stroke Home Care Patients.

Although stroke home care patients receive various treatments, they generally continue their lives as semi-dependent or fully dependent. Considering that stroke patients are especially elderly individuals, it is seen that they receive home health services and need a caregiver. The caregiver feels themselves under a heavy burden due to the lack of knowledge and insufficient experience. In addition, the lack of social support levels and the lack of training in patient care cause negative effects on patient outcomes.

The research will be carried out face-to-face with 70 stroke patients who receive health care from the home health services unit of a State Hospital and 70 individuals who care for these patients between July 2023 and December 2023. This study is a single-sample study with its own control group. During the implementation phase of the research, home visits will be made to the patients and training based on the Precede-Proceed model will be given to the individuals who care for the patients in the meeting room of the hospital where the research will be conducted. The collection of research data will take place in three stages. In the research, pre-education evaluation will be collected at the hospital before the training for the caregivers and home visits for the patients. In the second stage, the training program planned for the caregivers will be implemented in the meeting room of the hospital. After the training program reaches all of the caregivers in the determined number, the first evaluation will be made for the caregivers and the patient in the 8th week after the training is over. The third stage is the 16th week after the completion of the training, and the final evaluation will be made for the patients and caregivers. In the study, data will be collected using the individual caregiver personal information form, the caregiver response rating scale and the multidimensional perceived social support scale, and the patient personal information form for the patients. Statistical significance level will be accepted as p\<0.05.

Eligibility Criteria:
Inclusion Criteria:

* Individuals who care for semi-dependent or fully dependent stroke home care patients who agree to participate in the study,
* No communication problems,
* Do not have any psychiatric disorders that will reduce the ability to comprehend and understand,
* Caregivers over the age of 18.
* Semi-dependent or fully dependent stroke home care patients,
* Adult patients,
* Patients whose legal guardians or who have agreed to participate in the research themselves,

Exclusion Criteria:

* The refusal of caregivers or patients to participate in the study,
* The caregiver ceases to provide care or the patient dies during the research,
Predictive Value of DNA Mismatch Repair System in Colorectal Cancers

* Microsatellite instable (MSI) tumors represent almost the 15% of all sporadic colorectal cancers (CRCs).
* Literature data show that this unique tumor population appears to be poorly responsive to conventional chemotherapy and conversely reveals excellent results to immunotherapy.
* Our data, as demonstrated by propensity score-matched and win ratio analysis, show that there are no substantial differences between MSI and MSS tumors in early CRC stages treated with surgery alone.
* On the contrary, stable tumors (MSS) did much better than MSI tumors in advanced CRC stages undergoing conventional adjuvant treatment.
* Determination of status of DNA mismatch repair system is crucial in high-risk CRCs to optimize treatment.

Colorectal cancers (CRCs) with deficient DNA mismatch repair (MMR) system (so called dMMR or MSI tumors) represent a no-negligible part of sporadic CRCs. Prognostic value of this unique cell population remains controversial, but undoubtedly these tumors are characterized by poor response to conventional chemotherapy, an high tumor mutational burden resulting in a brisk immuno response, and, as recently observed, excellent results to the immunotherapy. The aim of this study was to evaluate, by using sophisticated statistical analyses, the predictive value of MSI status and its optimal treatment.

A series of 403 consecutive CRC patients treated by the same oncological team from 2014 to 2021 entered the study. No patients underwent immunotherapy. Immunohistochemistry, integrated by polymerase chain reaction if appropriate, was used to categorize specimens in microsatellite stable (MSS) and instable (MSI) tumors. The win ratio (WR) approach was utilized to compare composite outcomes of MSS and MSI tumors while controlling for radical versus no radical resection, propensity score-matched analysis, and reversing primary endpoint.

Eligibility Criteria:
Inclusion Criteria:

* all consecutive CRC patients observed from January 2014 to December 2021

Exclusion Criteria:

* Patients with suspected or confirmed Lynch's syndrome (12 patients) and rectal cancers (98 patients) undergoing neoadjuvant treatment
Neuro-cognitive Bases of Joint Action

The ability to interact with conspecifics is crucial in life, yet there is no consensus on the underlying cognitive and neural mechanisms beyond those associated with imitative behaviors. This project aims to define a coherent model of non-imitative (complementary) motor interactions. The investigators hypothesize that these might be substantially based on the ability to integrate one's own and a partner's action within a unitary, dual- person (dyadic), motor plan that incorporates a shared goal.

With a novel "minimally-joint" paradigm the investigators will test this hypothesis and measure with behavioral measures (i.e., reaction times) whether the supposedly automatic tendency to imitate others is modulated by the need to coordinate with a partner to achieve a shared goal.

This paradigm will be also applied during a functional MRI experiment to describe the underlying neurophysiological patterns; using dynamic causal modeling the investigators will measure how the brain regions relevant for dyadic motor control are functionally linked.

This converging experimental strategy will permit to compare competing psychological and neural models of motor interactions in healthy participants, opening new experimental avenues for studies in adult neuropsychological patients and in children with typical and atypical social development.


Eligibility Criteria:
Inclusion Criteria:

* right handed; no contraindication to MRI

Exclusion Criteria:

* contraindication to MRI
CBT4CBT-Buprenorphine + Recovery Coach for Office-based Buprenorphine

To conduct an 8-week pilot, randomized trial evaluating the feasibility, acceptability, and efficacy of an integrated intervention involving CBT4CBT-Buprenorphine + Recovery Coach in a population of 60 individuals who meet current DSM criteria for opioid use disorder and are receiving buprenorphine treatment in primary care.

In this pilot study, 50 individuals with OUD on buprenorphine will be randomized to either 1) standard of care (N=25) or (2)CBT4CBT-Buprenorphine + Recovery Coach (N=250). This will be an 8-week trial.

Eligibility Criteria:
Inclusion Criteria:

* adults (≥18 years)
* having a DSM-V diagnosis of OUD
* sublingual buprenorphine/naloxone and/or buprenorphine
* having initiated maintenance treatment for OUD for at least 30 days before the screening
* self-report or toxicology screening positive for any substance within 30 days of screening;
* willing to accept a random assignment to either TAU/CBT4CBT-Buprenorphine + Recovery Coach;
* having adequate computer skills

Exclusion Criteria:

* having a severe medical or psychiatric disability that could impair their ability to perform study-related activities (determined by the clinician)
* being pregnant or breastfeeding;
* being unable to independently read and/or comprehend the consent form or other study materials
* being unable to read/speak English;
* having current suicidal ideation based on the Patient Health Questionnaire-9.
Efficacy and Safety of a Treatment for Dry Eye Syndrome: Thealoz

The purpose of this study is to determine if Thealoz is effective in Dry Eye Syndrome exposed to controlled adverse environmental conditions.


Eligibility Criteria:
Inclusion Criteria:

* Man/woman ≥ 18 years old, able to freely give consent to participate in the study
* Fluorescein corneal staining ≥ 1 and ≤ 3 in Oxford Scales
* At least 2 of the following tests altered:
* Ocular Surface Disease Index (OSDI) Test symptoms between 12 and 40
* BUT ≤10 seconds
* Lissamine green conjunctival staining ≥ 1
* Schirmer Test without anesthesia ≤ 5 mm
* Informed consent signed
* Data protection consent signed

Exclusion Criteria:

* Sensitivity or known intolerance to any of the product used in the study
* Story of ocular infections or severe ocular inflammation within the 6 previous months to study inclusion
* Any active ocular pathology other than Dry Eye Syndrome
* Any traumatize or ocular surgery that may affect corneal sensitivity and/or normal tear distribution (e.g. cataract surgery, refractive surgery) within the 6 previous months to study inclusion
* Use of contact lenses in the 3 previous months to study inclusion
* Use of any ocular topical medications other than the treatment for Dry Eye Syndrome
* Ocular treatment for Dry Eye Syndrome with corticosteroids 1 month before inclusion visit or Cyclosporin A 3 months before inclusion
* Diagnosis of Rosacea or Severe Blepharitis (associated to systemic or ocular pathologies) Any severe uncontrolled systemic disease that may affect the eye (except for primary or secondary Sjögren)
* Start, discontinuation or change within the study of the dosage of antihistaminics, cholinergic agents, beta blockers, anti depressants or any other systemic drugs with potential effects in the tear film
* No pregnant or breastfeeding women is allowed to participate in the study. Childbearing potential women must use contraceptive means during the whole study.
* Participation in another clinical trial in the last 30 days before study inclusion
Application of CIELab Spectrophotometry to Analyze Gingival Color: a New Perspective for Evaluating the Effectiveness of Periodontal Basic Treatment

Objective: This study aims to explore the correlation between gingival color and clinical indicators and inflammatory factors in patients with periodontitis.

Method: This study aims to include 30 periodontitis patients who visited the Periodontology Department of the Second Affiliated Hospital of Zhejiang University School of Medicine from October 2024 to November 2024. The study adopted a self controlled before and after design. All subjects received periodontal basic treatment. Record the age, gender, ethnicity, skin color, and gingival biotype of the subjects. Before treatment, 6 weeks after treatment, and 12 weeks after treatment, check and record the blood routine, high-sensitivity C-reactive protein (Hs CRP), and interleukin-6 (IL-6) of all subjects. Use a moisture absorbing paper tip to collect the gingival crevicular fluid of the subjects, and further detect the levels of interleukin-17 (IL-17) and tumor necrosis factor alpha (TNF - α) in the gingival crevicular fluid samples, and record the periodontal table. Check and record the CIE indicators L \*, a \*, b \*, probing depth (PD), gingival bleeding index (SBI), and clinical attachment loss (CAL) in the keratinized gingival area of all subjects before and after treatment at 2, 6, and 12 weeks. Analyze and compare the changes in each group's data before and after treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Patients of Han ethnicity, aged between 18 and 65 years old, diagnosed with periodontitis
2. I haven't received any periodontal basic treatment, including scaling, scraping, flap surgery, etc., for the past six months
3. The anterior teeth area has not undergone periodontal surgery or coronal restoration within six months
4. The patient has clear thinking, unobstructed communication, and high compliance

Exclusion Criteria:

1. Cardiac function levels III and IV
2. Blood pressure\>180/110 mmHG
3. Pregnant women, women in pregnancy or lactation
4. Those who are currently taking anticoagulant drugs, calcium channel blockers, immunosuppressants, angiotensin and other medications, receiving bisphosphonates treatment, or have a history of antibacterial treatment within 3 months
5. Uncontrolled and stable patients with systemic diseases, such as progressive liver diseases, infectious diseases, renal failure, rheumatoid diseases, blood system diseases, osteoporosis, AIDS, mental diseases and diabetes, etc
6. Patients with malignant tumors or undergoing radiotherapy, chemotherapy, and targeted drug therapy
7. Patients with pacemakers who cannot undergo ultrasound therapy
8. Smoking or quitting smoking for less than 5 years
9. Individuals with abnormalities such as pigment deposition and keratinized beads in the front teeth and gums
Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Methotrexate and Have Had Inadequate Response to Single TNF-alpha Antagonist

The purpose of the study is to evaluate the effectiveness of two dosing regimens of fostamatinib compared to placebo, in patients with rheumatoid arthritis (RA) who are taking methotrexate and have had an inadequate response to a single TNF-alpha antagonist. The study will last for approximately six months.

Sub-study:

Full title: Optional Genetic Research

Date: 18 June 2010

Version: 1

Objectives: To collect and store, with appropriate consent ,DNA samples for future exploratory research into genes/genetic variation that may influence response (ie, absorption, distribution, metabolism and excretion, safety, tolerability and efficacy) to fostamatinib disodium and/or methotrexate; and/or susceptibility to, progression of and prognosis of RA

Eligibility Criteria:
Inclusion Criteria:

* Active rheumatoid arthritis (RA) diagnosed after the age of 16
* Currently taking methotrexate
* 6 or more swollen joints and 6 or more tender/painful joints (from 28 joint count) and either Erythrocyte Sedimentation Rate (ESR) blood result of 28mm/h or more, or C-Reactive Protein (CRP) blood result of 10mg/L or more
* At least one of the following: documented history of positive rheumatoid factor (blood test), current presence of rheumatoid factor (blood test), radiographic erosion within 12months prior to study enrolment, presence of serum anti-cyclic citrullinated peptide antibodies (blood test)

Exclusion Criteria:

* Females who are pregnant or breast feeding
* Poorly controlled hypertension
* Liver disease or significant liver function test abnormalities
* Certain inflammatory conditions (other than rheumatoid arthritis), connective tissue diseases or chronic pain disorders
* Recent or significant cardiovascular disease
* Significant active or recent infection including tuberculosis
* Previous failure to respond to anakinra or previous treatment with biological agent (other than TNF alpha antagonists including rituximab, abatacept and tocilizumab)
* Severe renal impairment
* Neutropenia
A Phase I/II to Assess Safety, Tolerability and Efficacy of DL-lactic Acid Syrup in Children With Recurrent Tonsillitis

The study objectives are to evaluate Tonsitin™ (10% Lactic Acid) safety, tolerability and preliminary efficacy, as a potent treatment for Recurrent Tonsillitis in children.


Eligibility Criteria:
Inclusion Criteria:

* Children at the ages of 5-16.
* Patient is suffering from recurrent documented sore throat with at least 4 tonsillitis episodes during the preceding year (at least one verified by culture or rapid antigen testing for Streptococcus A).
* Patient with clinical presentation of irregular tonsils.
* Tonsils size graded between 2.5-4.
* Clinical diagnosis of bacterial known in recurrent pharyngeal-tonsillitis.
* Patient is willing to participate in the study and adhere to the study protocol
* Patient's guardian and/or Patient have signed informed consent.

Exclusion Criteria:

* Clinical diagnosis of acute tonsillitis/pharyngitis caused by Streptococcus pyogenes (Positive RSAT or microbial culture).
* Subjects who are known as Streptococcus pyogenes carriers
* Subject's requiring any other medication (topical or systemic) that may affect the course of the disease during the study period (e.g. antibiotics, sedating antihistamines), and/or did not completed 14 days from end of antibiotics treatment.
* Subjects with known hypersensitivity to lactose.
* Subject is suffering from peritonsillar abscess.
* Subject suffers from an active peptic ulcer
* Subjects who are suffering from any concomitant disease which in the judgment of the investigator will interfere with the conduct or interpretation of the study results.
* Subject is currently participating in another clinical study.
Resiliency Program for Medical Interpreters

To develop and test a 4-session program to teach resiliency skills to Medical Interpreters.

This study aims to improve quality of cancer care for LEP patients through improving medical interpreters' ability to cope with difficult encounters. We propose to (1) identify the needs of medical interpreters working with cancer patients, and (2) develop and test a psychoeducational resiliency program at 3 DF/HCC cancer centers: MGH, DFCI, and BWH) intended to enhance interpreters' skills to effectively manage stressful encounters and to cope with the personal effects of encounters.

Eligibility Criteria:
Inclusion Criteria:

1. Interpreter employed at one of the 3 study hospitals
2. \>=20 hours/week

Exclusion Criteria:

1) Interpreter working \<20 hours per week
Postmarketing Immunogenicity Study in HAE Subjects Treated With Berinert

This is a prospective, international, multi-center, non-randomized, single arm, open-label, postmarketing study to investigate the formation of inhibitory anti-C1-INH antibodies in HAE subjects treated intravenously with Berinert. Individual treatment duration per subject is 9 months, irrespective of the number of treated attacks. All subjects will receive 20 IU Berinert/kg body weight per attack.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of congenital C1-INH deficiency (HAE type I or II) and assessed by the investigator to likely require intravenous (IV) Berinert treatment during the study period.
* Male or female, ≥ 12 years of age at the time of signing informed consent.
* Written informed consent for study participation obtained before undergoing any study specific procedures.

Exclusion Criteria:

* Incurable malignancies in the last 6 months prior to study entry.
* Acquired angioedema due to C1-INH deficiency.
* All other types of angioedema not associated with C1-INH deficiency.
* Use of any C1-INH products other than Berinert within 30 days before the study, or planned use during the study.
* Immunization within 30 days prior to study entry.
* Autoimmune conditions requiring use of immunosuppressants during the study.
* Known or suspected hypersensitivity to C1-INH.
* Participation in any of the previous Berinert studies from which anti-C1-INH antibody results were submitted to the Food and Drug Administration.