cyrilzakka/clinical-trials huggingface dataset:
Single-cell RNAseq Breast Cancer

Molecular characterization of persistent tumor cells remaining after NAC and infiltrating immune cells, for example, M2 macrophages, could strongly contribute to identifying targeted therapeutic approaches for this disease.

Triple negative breast cancer (TNBC) represents approximately 15-20% of all breast cancers. Its features are lack of expression of estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor receptor 2 (Her2). TNBC exhibits a biologically aggressive behavior and a high inter- and intra-tumor molecular heterogeneity which has recently been highlighted also in single cell RNAseq (scRNAseq) studies. Patients with TNBC often have less positive outcomes then other breast cancer subtypes, due to the absence of specific therapeutic targets.

Results of single cell RNA sequencing (scRNAseq) in TNBC before and after treatment with chemotherapy (NAC) were recently reported for a small group of patients. Genetic alterations are also investigated by Whole Exome Sequencing (WES).

In addition scRNAseq analysis confirmed the presence of a high percentage of M2 macrophages in TNBC and tumor-adjacent tissue. These macrophages are clinically relevant and able to predict outcome in TNBC.

Based on the above evidence, we hypothesize that molecular characterization of persistent tumor cells remaining after NAC and infiltrating immune cells, for example, M2 macrophages, could strongly contribute to identifying targeted therapeutic approaches for this disease.

We will conduct a pilot study with a combined retrospective and prospective observational design.

Cancer patients diagnosed with histologically proven primary invasive breast cancer with a stage IIA to IIIB and assessed at the molecular level and defined as TNBC, will be eligible to participate to the study. Furthermore, only patients with a tumor \>1.5cm in size will be considered, which is the selection criterion for the administration of neoadjuvant therapy.

Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically proven primary invasive breast cancer \>1.5cm in size, with molecular assessed stage IIA to IIIB defined as TNBC, and who will undergo neoadjuvant chemotherapy and subsequent surgery (and/or have undergone - retrospective part).
* informed consent (prospective part)

Exclusion Criteria:

* pregnancy, metastatic breast cancer, previous chemotherapy, hormone therapy, radiation therapy, previous other cancers or contralateral breast cancer
Prevention of Alopecia in Patients With Localised Breast Cancer

The prevention of chemotherapy-induced alopecia (CIA) is still imperfectly managed in France. Strengthening the evidence base on the benefits of strategies to prevent CIA, based on robust methodologies, remains a prerequisite for better integration of appropriate supportive care for patients receiving chemotherapy.

This research should provide new knowledge on the benefits of scalp refrigeration during anthracycline- and taxane-based chemotherapy in preventing ACI, for each of the 2 refrigeration techniques. In addition to effectiveness in preventing ACI, quality of life, self-image and satisfaction with care will be assessed by patients during and after chemotherapy. The medico-economic aspects will also be assessed for each of the two refrigeration modalities. The results of the various proposed assessments will be used to guide the choice between these two techniques for preventing ACI.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18
* Female
* Histologically proven diagnosis of localised, non-metastatic breast cancer
* Indication for neo-adjuvant or adjuvant anthracycline and taxane chemotherapy (3 EC100 followed by 3 Docetaxel or 3 EC100 plus 12 Paclitaxel); HER-positive status is not a non-inclusion criterion.
* Patient willing to be photographed to assess IFA
* Fluency in French
* Patient affiliated to a social security scheme
* Signature of informed consent

Exclusion Criteria:

* History of neck pain
* Pre-existing alopecia
* Participation in another trial
* Dermatosis of the scalp
* Contraindication to scalp cooling
* History of migraines, stroke or hyperthyroidism
* History of scalp metastases
* Sensitivity to cold, cold agglutinin disease, cryoglobulinaemia, cryofibrinogenaemia or post-traumatic cold dystrophy.
* Malignant haemopathies
* History of chemotherapy treatment
* Indication for cerebral irradiation
* Pregnant or breast-feeding patient
* Raynaud's syndrome
Results of Different Location of Ahmed Glaucoma Valve Implantation in Refractory Glaucoma, Superior Versus Inferior

Purpose:To compare the efficacy and safety of Ahmed Glaucoma Valve (AGV) implantation in the superior versus inferior quadrants.

Methods: In a non-randomized clinical trial and over a period of two years, consecutive patients with refractory glaucoma underwent AGV implantation in the superior or inferior quadrants. Main outcome measures included best corrected visual acuity (BCVA), intraocular pressure (IOP), number of glaucoma medications, complications and success rate (defined as at least 30% IOP reduction below preoperative values and 5\<IOP\<22 mmHg with or without glaucoma medications). Other criteria for failure included implant removal, additional glaucoma surgery, phthisis bulbi or loss of light perception.


Eligibility Criteria:
Inclusion Criteria:

* Patients with refractory glaucoma who need AGV implantation

Exclusion Criteria:

* Eyes with less than 3 months follow-up
* Severe conjunctival adhesions and scarring for the site of surgery
* Presence of thin sclera and staphyloma for the site of surgery
* The presence or anticipated need for silicone oil for superior implantation
* Active neovascular glaucoma for inferior implantation
Group- Versus Individual-Mindfulness-Based Cognitive Therapy: a Randomized Trial

The purpose of this study is to determine whether both group and individual mindfulness-based cognitive therapy (MBCT) are effective in reducing depressive symptoms in patients with a chronic somatic disease.

Depression is a common co-morbidity in patients with a chronic somatic disease which has a negative impact on patients' physical and mental health. In recent years, Mindfulness-Based Cognitive Therapy (MBCT) has gained interest and popularity as a treatment not only for preventing recurrence of depression, but also to treat current symptoms. Usually, the training is delivered in group format, thus little is known about the feasibility and effectiveness of MBCT as an individual training.

This pilot study aims to compare the effectiveness and feasibility of group and individual MBCT in reducing depressive symptoms in patients with a chronic somatic disease.

Eligibility Criteria:
Inclusion Criteria:

* Chronic somatic disease
* Age ≥ 18 and ≤ 70
* Depressive symptoms as assessed by BDI-II score ≥ 14 (cut-off score indicating the presence of at least mild symptoms of depression)

Exclusion Criteria:

* Not being able to read and write Dutch
* Severe (psychiatric) co-morbidity
* Acute suicidal ideations or behavior
* Receiving an alternative psychological treatment during or less than two months prior to starting the participation in the study

Using an antidepressant drug during participation in the present study is allowed, on condition that a patient has been on stable medication regimen for at least two months prior to inclusion in the study, and that no new treatment with an antidepressant is initiated during the course of the study
Nab-paclitaxel Compared With Docetaxel Followed by Anthracyclines and Cyclophosphamide in the Neoadjuvant Breast Cancer

This study is an open, multicenter, randomized controlled clinical trial for patients with newly diagnosed primary invasive breast cancer and clinical stage of T2 or above. The main purpose of this study is to evaluate the efficacy of dose-dense nab-paclitaxel compared with dose-dense docetaxel followed by anthracycline and cyclophosphamide in the treatment of HR positive and HER-2 negative breast cancer. The effectiveness and safety of the treatment.


Eligibility Criteria:
Inclusion Criteria:

* 1) age: 18-70 years old, female;

  2) patients with primary breast cancer, T2 or above, diagnosed by histopathology;

  3) HR was positive and HER-2 was negative by IHC;

  4) according to the RECIST 1.1 standard, there should be at least one measurable objective focus with tumor diameter \> 2cm;

  5) ECoG physical fitness score 0-1;

  6) LVEF≥55%；

  7) bone marrow function: neutrophil ≥ 1.5 × 109 / L, platelet ≥ 100 × 109 / L, hemoglobin ≥ 90g / L;

  8) liver and kidney function: serum creatinine ≤ 1.5 times the upper limit of normal value; AST and alt ≤ 2.5 times the upper limit of normal value; total bilirubin ≤ 1.5 times the upper limit of normal value, or patients with Gilbert's syndrome ≤ 2.5 times the upper limit of normal value;

  9) patients have good compliance with the planned treatment, can understand the research process of this study and sign the written informed consent

Exclusion Criteria:

* 1) previously received cytotoxic chemotherapy, endocrine therapy, biological therapy or radiotherapy for any reason;

  2) patients with stage IV metastasis at the initial diagnosis;

  2) New York Heart Association (NYHA) rating of patients with heart disease above grade II (including grade II);

  3) patients with serious systemic infection or other serious diseases;

  4) patients who are known to be allergic or intolerant to chemotherapy drugs or their adjuvants;

  5) in the past 5 years, there have been other malignant tumors, except the cured carcinoma in situ of cervix and skin cancer without melanoma;

  6) pregnancy or lactation, as well as childbearing age patients who refuse to take appropriate contraceptive measures during the trial;

  7) participated in other experimental studies within 30 days before the administration of the first study drug;

  8) patients not suitable for the study were judged by the researchers.
Diazepam Vaginal Suppositories for High Tone Pelvic Floor Dysfunction.

The purpose of this study is to determine whether vaginal diazepam suppositories are an effective treatment of high tone pelvic floor dysfunction.

High tone pelvic floor dysfunction is a common cause of pelvic pain in females. It is thought to be initiated by a sentinel event such as trauma, surgery, or vaginal delivery1. Currently, treatment options include warm baths, stretching, physical therapy with myofascial therapy or biofeedback, or pharmacologic therapy with oral amitriptyline or tiazadine2. Physical therapy can be effective. However, it usually involves frequent visits to a specialized physical therapist to undergo intravaginal treatments consisting of myofascial release, massage, or biofeedback. We would like to find a treatment option for patients that would be effective without the invasive and time consuming nature of physical therapy. It is known that diazepam is a valid treatment option for disorders involving spasticity including spastic cerebral palsy5 and tetanus. A literature search on diazepam and high tone pelvic floor dysfunction revealed one paper. This study has an intrinsic flaw as it is a retrospective chart review, and the results are confounded by concurrent physical therapy. They were, however, able to find that patients treated with diazepam suppositories showed a significant improvement in pelvic floor tone. They also assessed pain and sexual function, but these did not reach statistical significance.

Eligibility Criteria:
Inclusion Criteria:

* candidates from the Division of Urogynecology at Good Samaritan Hospital in Cincinnati, OH
* aged 18-65
* high tone pelvic floor dysfunction

Exclusion Criteria:

* allergy to diazepam or any drug in the class of benzodiazepines
* current pelvic floor physical therapy
* pelvic surgery within the last 3 months
* current pregnancy, planning on pregnancy during the study period, or not sure if pregnant
* regular benzodiazepine, muscle relaxant, or daily alcohol use
* history of alcohol or drug abuse
* contraindications to diazepam: hepatic or renal dysfunction, myasthenia gravis, acute narrow angle glaucoma, severe respiratory insufficiency, sleep apnea
Movement and Fitness Trackers in Determining Performance Status

This trial studies the use of movement and fitness trackers in determining performance status of patients with cancer who are taking part in early phase clinical. Movement and fitness trackers record movement and a number of different metrics such as steps, heart rate, and calories burned. The use of movement and fitness trackers can provide a more objective and precise estimate of patient performance status and help identify those most at risk for adverse events and hospitalization.

PRIMARY OBJECTIVES:

I. To determine if in-office movement trackers identify those patients who are at highest risk for serious adverse events (SAEs) on early and developmental therapeutics (EDT) cancer trials.

SECONDARY OBJECTIVES:

Secondary objectives are related to outpatient activity trackers. I. To determine the association between the occurrence of SAEs and early trial termination, with baseline measurement of activity classification using outpatient activity trackers in the 7 days after screening visit.

II. To determine the association between the occurrence of SAEs and early trial termination, with the change in activity level classification between the week after screening visit and the week after the start of EDT.

III. To determine the association between the occurrence of SAEs and early trial termination, with averaged activity level classification in the first 4 weeks of the EDT.

OUTLINE:

Patients participant in movement assessment during 2 clinical trial visits. Patients also wear a Fitbit to track movements and complete a smartphone based Patient Reported Outcomes (PRO) diary over 5-10 minutes to measure physical function, fatigue, sleep disturbance, social isolation, appetite, and body weight for up to 180 days.

Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of cancer.
* Undergoing screening for a University of Southern California (USC)/Norris therapeutic clinical trial operated by the Early and Developmental Therapeutics Program which includes both phase I and II clinical trials.
* Owns a smartphone.
* Ability to understand and the willingness to sign a written informed consent.
* Willingness to wear sensors to track physical activity, Global Positioning System (GPS) location, and provide symptom ratings each night during the screening period of their clinical trial and 180 days after starting treatments.
* Able to read English, Spanish, or traditional Chinese to complete patient reported outcomes.
* Able to ambulate without an assistive device.

Exclusion Criteria:

* Missing lower limbs.
* Symptomatic brain metastases are excluded from this clinical trial. However, those with asymptomatic brain metastasis are permitted. It is permissible to have the patient on corticosteroids to eliminate symptoms of brain metastasis.
* Known movement disorder such as Parkinson?s disease, choreoathetoid movement disorders, essential tremor if that movement disorder is of sufficient severity to require drug therapy.
EFT and Music on Psychological Development, Well-Being Status and Cortisol Level in Pregnant Women

Emotional freedom technique and music were applied to pregnant women who experienced prenatal loss. Emotional freedom technique group, music group and control groups each consisted of 53 pregnant women.

Aim: The research is conducted to determine for the purpose of the effect of emotional freedom technique and music applied to pregnant women having experienced prenatal loss on psychological development, well-being status, and cortisol level.

Material and Method: The research is conducted in a randomized controlled manner with a total of 159 pregnant women who applied to the gynecology outpatient clinics of Elazig Fethi Sekin City Hospital between October 2020 and April 2021 (53 EFT, 53 music, 53 control). In the research, EFT was applied to the pregnant women in the EFT group twice, with an interval of one week; pregnant women in the music group were listened to music twice, with a one-week interval. Pregnant women continued the attempts for one week after the first attempt. SUDS, SUE Scale, PTGI, WHO-5 WellBeing Index were used to collect data, and a saliva sample was taken.

Eligibility Criteria:
Inclusion Criteria:

1. Anxiety level is 1 and above when measured with the subjective discomfort unit scale (Appendix 3),
2. 18 years old and over,
3. There are no conditions such as infection, wound, scar in the tapping areas,
4. All pregnant women who did not have any health problems (such as preeclampsia, diabetes, heart disease, placenta previa, oligohydramnios, fetal anomaly) during pregnancy and baby were included in the sample.

Exclusion Criteria:

1. Having any problem that prevents communication (such as not knowing Turkish, having hearing, speaking and understanding abilities),
2. Contaminated salivary cortisol,
3. Those with psychiatric health problems according to their medical records were excluded from the study.
Predicton of Sepsis Recovery Performance Subtypes Pilot Study

This study addresses critically ill sepsis patients' current literature reports of ongoing post-hospital discharge weakness and hospital readmissions. This study is aimed at capture and interpretation of a complex set of tests, administered during a subject's sepsis functional recovery trajectory, particularly capturing hospital readmission's effects on survivors' physical function recovery.

Patients with Sepsis who require ICU care, experience frequent weakness, physical dysfunction, fatigue, difficulty concentrating, poor memory, and mental morbidity that persists after hospital discharge. This syndromic pattern has been labeled as Post Intensive Care Syndrome (PICS) or Post Sepsis Syndrome (PSS). These patients are at increased risk of rehospitalization (up to 40% at 6 months). Studies have pointed out that sepsis survivors recover within several different recovery patterns or trajectories. Unfortunately there are no objective biomarkers early in these patients' hospitalizations, to predict which physical function trajectory a sepsis survivor will experience. However, a very common, unifying symptom of sepsis survivors is weakness. The literature maintains that an intervention of exercise rehabilitation remains a safe and potential therapy for sepsis survivors. It is important to note that as of yet, there has been no benefit demonstrated when highly heterogeneously functioning survivors are included in studies of a uniform rehabilitation intervention. However, for the future designs of ICU and post-hospital ICU Survivor exercise-rehab trials, the field is in need of information on how to label sepsis patients by their predicted outpatient recovery trajectory group, and to be able to do so very proximally in their course, prior to hospital discharge. The intent of this study is to closely track and characterize physical function recovery trajectory groups as a means of informing strategies for effective future study design.

Eligibility Criteria:
Inclusion Criteria:

* Sepsis requiring organ support in an ICU setting

Exclusion Criteria:

1. inability to obtain informed consent
2. the attending physician reports that the patient's goals of care are transitioning to palliation/withdrawal of life-sustaining therapy
3. recent cancer therapy in the last 12 months
4. age \>80
5. plans to be discharged on mechanical ventilation to a Long Term Acute Care Hospital
6. planned discharge to rehabilitation facility, long-term hospital or nursing home.
7. Pregnancy
Sentinel Lymph Node Biopsy in Early Breast Cancer: a Real-world Multicenter Cross-sectional Study (CABS001 Study)

Objective: To investigate the current clinical practice of sentinel lymph node biopsy (SLNB) in patients with early stage breast cancer in China. Methods: The data of early breast cancer patients who underwent SLNB in 40 Grade III Level A hospitals in China in 2018 will be collected. Different centers, tracer methods, molecular typing and neoadjuvant chemotherapy will be used as stratification factors to analyze the implementation rate, number of detections, positive rate of SLNB and the follow-up treatment.


Eligibility Criteria:
Inclusion Criteria:

* breast cancer confirmed by fine needle aspiration or biopsy
* SLNB with or without axillary lymph node dissection
* receiving conventional systematic treatment or regional treatment
* complete medical record.

Exclusion Criteria:

* IV stage breast cancer
* combined with secondary invasive malignant tumor
* diagnosed with other serious disease, including congestive heart failure (NYHA cardiac function grade II, III, IV) or congestive heart failure, unstable angina pectoris, myocardial infarction, high-risk uncontrollable heart rate disorder or other serious cardiovascular diseases within 6 months
* difficulty breathing at rest or need oxygen therapy
* severe infection
* uncontrolled diabetes
* serious psychological or mental disorders
* poor compliance.
Differences in Muscle Activity Patterns and Graphical Product Quality in Children With Graphomotor Impairment

Drawing on a vertical surface, rather than horizontal (such as blackboard) is often used by occupational therapists as a way of developing fine motor control and visual motor integration in children. In healthy children no difference in graphical quality was shown between drawing on vertical or horizontal surfaces. However, this was not investigated in children with graphomotor impairments.

The goal of this study is to determine whether movements produced on a vertical surface differ in their performance level and muscle activation patterns compared to movements produced on a horizontal surface. The investigators predict that there would be a difference in the level of performance between the two surfaces.

Drawing on a vertical surface, such as a blackboard (rather than a horizontal surface) is often used by occupational therapists as a way of developing fine motor control and visual motor integration in children. While there is anecdotal evidence to support this intervention, preliminary results in healthy children showed no differences in graphical quality while drawing on vertical or horizontal surfaces. This however was not investigated in children with graphomotor impairments.

The goal of this study is to determine whether movements produced on a vertical surface differ in their performance level and muscle activation patterns compared to movements produced on a horizontal surface.

The investigators predict that the level of performance on the vertical surface will exceed the level of performance on the horizontal surface. Additionally, the investigators hypothesize that the proximal muscles will be more activated and fatigued (in longer tasks) while drawing on the vertical surface, while the distal muscle will be more activated and fatigued while drawing on the horizontal surface.

Eligibility Criteria:
Study group Inclusion criteria:

* Up to 50 percentile in the long form Beery-Buktenica Developmental Test of Visual-Motor Integration (Beery VMI).

Exclusion Criteria:

* children in special education,
* any orthopedic or neurologic impairment,
* visual impairment that could not be corrected with glasses, or
* ability to understand and follow simple instructions, reported by the parents.