cyrilzakka/clinical-trials huggingface dataset:
A U.S. Registry of Eosinophilic Esophagitis Adolescent and Adult Patients Treated With DUPIXENT® As Standard of Care

This observational research study is to better understand patients with eosinophilic esophagitis (EoE) who have recently been prescribed DUPIXENT® (dupilumab). The purpose of this research study is to look at how DUPIXENT is used in normal care of patients with EoE.

Possible benefits to others include a better understanding of EoE and helping to inform research and clinical trial design leading to treatment decisions in this patient population going forward.

Patient questionnaires will measure the following:

* How EoE makes one feel
* EoE symptoms
* How EoE affects quality-of-life
* How EoE impacts aspects of daily life
* How difficult it is to swallow
* How EoE symptoms have changed throughout the study


Eligibility Criteria:
Key Inclusion Criteria:

1. Initiating treatment with DUPIXENT® for EoE according to the USPI
2. Able to understand and complete registry-related questionnaires (including adolescents)

Key Exclusion Criteria:

1. Patients who have a contraindication to DUPIXENT® according to the USPI
2. Treatment with DUPIXENT® within the 6 months prior to the screening assessment
3. Participation in an ongoing interventional study on or within 6 months of the baseline assessment. Once enrolled in registry, participation is allowed in other ongoing studies (at the discretion of the registry investigator)

NOTE: Other protocol defined inclusion/exclusion criteria apply
The Effects of Temporary Ileostomy on Outcome in Patients With Rectal Cancer

The purpose of this prospective comparative cohort study was to assess the effect of protective ileostomy on the outcomes of patients with rectal cancer who underwent low anterior rectal (LAR) resection in patients with a diagnosis of colorectal cancer of both sexes and all ages that required low anterior resection(LAR) attending the Department of General Surgery at Tishreen University Hospital in Lattakia-Syria during the two years (May 2021- May 2023). the main question to answer is does protective ileostomy reduce leakage, SSI rate, and duration of hospitalization in patients with colorectal cancer. . Patients are divided into two groups: group 1: patients who underwent ileostomy (19 patients), and group 2 is the comparative group: patients who didn't (28 patients). Morbidity and mortality were compared between the two groups, to study the outcomes of protective ileostomy

Anastomotic leakage is encountered frequently after colorectal cancer (CRC) surgery, which is considered one of the potentially lethal complications, affecting the quality of life and increasing hospital costs. The role of a protective stoma has been debated. Therefore, The purpose of this study was to assess the effect of protective ileostomy on the outcomes of patients with rectal cancer who underwent low anterior rectal (LAR) resection.

This is a prospective comparative study of a group of patients with a diagnosis of colorectal cancer of both sexes and all ages that required low anterior resection(LAR) attending the Department of General Surgery at Tishreen University Hospital in Lattakia-Syria during the two years (May 2021- May 2023). The exclusion criteria were patients who underwent abdominoperineal resection with permanent ileostomy. The following workup included: a history and physical examination.

Preparation of the bowel was performed before surgery with the administration of intravenous perioperative antibiotic prophylaxis. The surgical procedure was performed by laparotomy, with resection of the rectum and mesorectum (TME) up to the level of the pelvic diaphragm, sparing the autonomic nerves. End-to-end anastomosis was performed either with a stapler or by hand-sewn. Patients were assigned to group I (19 patients) who had undergone temporary ileostomy, and group II (28 patients) who didn't undergo ileostomy. Patients were followed up at regular intervals and outcomes were compared between two groups.

Eligibility Criteria:
Inclusion Criteria:

* patients with a diagnosis of colorectal cancer that required low anterior resection(LAR)
* Both sexes
* All ages
* Attending the Department of General Surgery at Tishreen University Hospital in Lattakia-Syria during the two years (May 2021- May 2023).

Exclusion Criteria:

* Patients who underwent abdominoperineal resection with permanent ileostomy.
The Effect of Showing Photographs, Videos and Live Images of Their Babies to Mothers During Milking

The study was planned to determine the effect of showing photographs, videos and live images of premature babies who could not be breastfed in the neonatal intensive care unit to their mothers on the amount of breast milk, mother-infant attachment and breastfeeding self-efficacy.

It is a randomized controlled experimental study.

Separation of the baby from the mother, being admitted to the neonatal intensive care unit can quickly increase the mother's fears about her baby's health and appearance, it can be interpreted as a crisis for the family. When the baby is in the intensive care unit, it also becomes difficult for parents to participate in the care of the baby.

In this case, one of the negative emotions that parents often experience is anxiety.

In general, mothers experience more intense stress than fathers.The mother, who is away from her baby's care, feels tense, irritable and confused. She makes an effort to reach her baby, and when she fails to do so, she finds herself helpless and powerless. The neonatal intensive care nurse and the Women's Health nurse play a major role in the initiation of breastfeeding and the continuation of breastfeeding in pre-term newborns.

Early milking of mothers after premature birth increases breast milk production.

Despite early and frequent milking, some mothers may experience lower milk volume and milk production in the first few weeks. Therefore, mothers with premature babies should practice frequent breastfeeding/milking, massage and compression, hot application, acupuncture, yoga and relaxation exercises, etc., in order to increase prolactin secretion and increase breast milk production. focused on non-pharmacological methods such as. Another method that is considered effective is to show the mother a photo or video of the baby during milking. However, in the literature review, the number of available studies on this subject is only 2.

One of these studies was done in 2020. The other study was done in 2021. More work is needed on this subject. The aim of this study was to determine the effects of watching photos, videos and live images of babies during milking on the amount of breast milk, mother-infant attachment and breastfeeding self-efficacy.

Eligibility Criteria:
Inclusion Criteria:

* Staying of the baby in the Neonatal Intensive Care Unit
* 34 weeks of gestation and below
* Mother's acceptance of the application
* The mother's inability to breastfeed her baby
* The mother has a smart mobile phone
* Mother's ability to read and write
* Being able to communicate with the mother (being able to read and write, speak Turkish, etc.)

Exclusion Criteria:

* Gestation week over 34
* The mother is breastfeeding her baby
* Being a smoker
* Having a systemic disease and constantly taking medication(s)
* Having a health problem that may affect the mother's milking (crack, mastitis, collapse etc.)
Exploring the Genetics of Neuropathic Pain

In the present study the investigators will search for new genetic variants relevant for the development of neuropathic pain.

Neuropathic pain is defined as "pain caused by a lesion or disease of the somatosensory nervous system". Neuropathic pain is a huge health problem worldwide, with an estimated prevalence of 7-8 % in the general population. In the present study the investigators will search for new genetic variants relevant for the development of this type of pain.

Peripheral nerve lesions only progress to neuropathic pain in some patients, yet is not completely understood why or how. Genetic studies of patients with rare neuropathic disorders have been important for elucidating novel molecular mechanisms of neuropathic pain, and new drugs for neuropathic pain are now being developed based on these findings. By using genetic association studies, one may identify new genetic variants which may help to identify key molecular mechanisms for a larger group of patients with neuropathic pain.

This project will use existing population-based cohorts, as well as establish a specific registry and biobank for patients with neuropathy in order to address these specific needs. This will allow the investigators to identify a large number of individuals with probable neuropathic pain and individuals with pain-free peripheral neuropathy (disease controls). International collaboration will contribute to study a large group of patients, which will be important in order to reach the project's goals. The results from the project are expected to increase current knowledge on the mechanisms of neuropathic pain, opening up new opportunities for innovative and improved treatments.

Dissemination of results will be organized in close collaboration with patient representatives, and will be done regularly throughout the course of the project. The will focus both on internal dissemination to the participating hospitals, and external dissemination through participation in conferences, submissions to scientific journals and by publishing patient-friendly information booklets and proactively informing media outlets and patient organizations.

Eligibility Criteria:
Inclusion Criteria:

1. The patient is between 18 and 70 years old.
2. The patient has consented.
3. The patient is referred for evaluation of possible distal symmetric polyneuropathy (DSPN).
4. The patient has filled out the questionnaires.

Exclusion Criteria:

1. The patient is too sick to participate (eg. bedridden, fever).
2. The patient is unable to consent (eg. dementia, speech problems, psychiatric disorder).
3. Inflammatory acute polyneuropathy.
Safety and Efficacy Study of a Dual PI3K Delta/Gamma Inhibitor in Hematological Malignancies

The objective of this study is to evaluate the safety and efficacy of RP6530, a dual PI3K delta/gamma inhibitor in patients with hematologic malignancies.

The Maximum tolerated dose (MTD) will be determined based on the safety, pharmacokinetic (PK) and efficacy data. Safety analyses include AE's, AE's related to the drug, SAE's, laboratory values, vitals/ ECG and dose limiting toxicity (DLT). PK include measurement of peak plasma concentration (Cmax), area under the plasma concentration versus the time curve (AUC), time of maximum concentration observed (Tmax). Efficacy analyses include overall response rate (ORR) and duration of response (DOR).

Eligibility Criteria:
Inclusion Criteria:

* Refractory to or relapsed after at least 1 prior treatment line.
* ECOG performance status ≤2
* Patients must be ≥18 years of age
* Able to give a written informed consent.

Exclusion Criteria:

* Any cancer therapy in the last 4 weeks or limited palliative radiation \<2 weeks
* Patients with HBV, HCV or HIV infection
* Autologous hematologic stem cell transplant within 3 months of study entry. Allogeneic hematologic stem cell transplant within 12 months.
* Previous therapy with GS-1101 (CAL-101, idelalisib), IPI-145, TGR-1202 or any drug that specifically inhibits PI3K/ mTOR (including temsirolimus, everolimus), AKT or BTK Inhibitor (including Ibrutinib).
* Patients on immunosuppressive therapy including systemic corticosteroids.
* Patients who are receiving chronic systemic anticoagulation therapy (warfarin sodium or heparin, etc.).
* Patients with known history of liver disorders.
* Patients with uncontrolled Diabetes Type I or Type II
* Any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study.
* Women who are pregnant or lactating.
Overview of Telemedicine in Children With Type 1 Diabetes

Assessment of the proportion of pediatric patients with type 1 diabetes with access to remote monitoring

In the follow-up of type 1 diabetes in children, contact with families besides the appointements with medical et paramedic staff (paediatrician, diabetologist, nurses) is very common but not well coded, start from telehealth hubs (like myDiabby), to less unofficial contact by phone or email. This is even more so widespread since generalization of continuous glucometer (freestyle, dexcom,...), which allowed a quick data transfer to the medical staff.

Some studies had shown that telemedicine in diabetes allowed a better glycemic control and a higher implication in the desease. Indeed, in 1999 already, HbA1c significant improvement was shown when patients was regularly called by a nurse (Thompson et al.). Same finding was demonstrated in Schiaffini and al. clinical trial in 2016. This trial also shown a better adhesion to the follow up into the telemedicine group. Despite all of this studies, in France, remote monitoring isn't standardised and financed, except the national experimentation ETAPES which promotes and financially supports the deployment of remote monitoring projects around the territory.

Eligibility Criteria:
Inclusion Criteria:

* Children with type 1 diabetes

Exclusion Criteria:

* No consent
Combination Chemotherapy With or Without G-CSF in Treating Patients With Relapsed Chronic Lymphocytic Leukemia

RATIONALE: Drugs used in chemotherapy, such as fludarabine, mitoxantrone, and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. Colony stimulating factors, such as G-CSF, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of combination chemotherapy. It is not yet known whether giving combination chemotherapy alone is more effective than combination chemotherapy together with G-CSF in treating patients with chronic lymphocytic leukemia.

PURPOSE: This randomized phase III trial is studying giving combination chemotherapy together with G-CSF to see how well it works compared to giving combination chemotherapy alone in treating patients with relapsed stage I, stage II, stage III, or stage IV chronic lymphocytic leukemia.

OBJECTIVES:

Primary

* Compare the rate of remission, severe infections, and side effects in patients with relapsed advanced chronic lymphocytic leukemia treated with fludarabine, mitoxantrone hydrochloride, and cyclophosphamide with vs without filgrastim.

Secondary

* Compare the overall survival, progression-free survival, and quality of remission in these patients.

OUTLINE: This is a multicenter, randomized study. Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive fludarabine IV on days 1-3, mitoxantrone hydrochloride IV on day 1, and cyclophosphamide IV on days 1-3.
* Arm II: Patients receive fludarabine, mitoxantrone hydrochloride, and cyclophosphamide as in arm I and filgrastim (G-CSF) beginning on day 6 and continuing until blood counts recover.

In both arms, treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 165 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Confirmed relapsed and advanced chronic lymphocytic leukemia (CLL)

  * Binet stage B or C disease with rapid disease progression, enlarged lymph nodes and organs, or severe B-symptoms
* No prior non-response to fludarabine combination therapy

PATIENT CHARACTERISTICS:

* ECOG performance status 0-3
* Life expectancy \> 6 months
* No severe organ dysfunction
* No other prior or concurrent neoplasm, autoimmune hemolytic anemia, or thrombocytopenia

PRIOR CONCURRENT THERAPY:

* No more than three previous treatment regimens for CLL (fludarabine allowed)
Referred Pain Areas in Subjects With a Recovered Radius Fracture

The purpose of the present study is to investigate pressure algometry and pressure-induced referred pain areas in pain free individuals with a history of distal radius fracture (fully recovered) compared with age and gender matched healthy controls without history of fracture. It is hypothesized that individuals with a recovered radius fracture will have a facilitated referred pain patter towards the wrist but normal pressure pain sensitivity.

Musculoskeletal injuries, nociception and pain can increase the sensitivity of the central pain mechanisms, which can be extended even after tissue recovery. However, little is known about the status of these central pain mechanisms once subjects are fully recovered from the tissue injury and pain. This information would help to explain pain conditions in which recurrence of the pain episodes is common (e.g low back pain or shoulder pain).

Pressure-pain thresholds have been widely used in pain research to test the sensitivity of the pain system. Additionally, referred pain has been shown as a valid biomarker for the sensitization of the pain system.

The aim of the present study is to investigate pressure pain sensitivity and referred pain patterns of individuals with a history of recovered fracture, compared with healthy controls.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with a history of distal radius fracture without pain at the moment of the study.

Exclusion Criteria:

* Subjects with symptoms (e.g pain), functional limitations, history of other fractures in the upper limb or any other pathology.
Interactive Perioperative Teaching Platform (IPTP)

The proposed study will assess whether an interactive perioperative teaching platform (IPTP) provided to families of patients undergoing ambulatory pediatric surgery will reduce families' anxiety, and improve satisfaction and understanding, relative to current practice. The IPTP will educate patient families on the continuum of their child's surgical experience, from arriving at the hospital through registration, the operating room (OR), and the hospital floor. An active video format will be used to provide instructions for navigating the hospital; describe induction of anesthesia and the surgical procedure; and provide post-surgery and post-discharge instructions for pain management. A comparison cohort of patients undergoing surgery without access to the IPTP will be recruited to assess the benefits of the IPTP for improving metrics of family satisfaction, preoperative anxiety, and postoperative understanding of discharge instructions.


Eligibility Criteria:
Inclusion Criteria:

* Children aged 0-18 years
* Undergoing adenotonsillectomy or orchiopexy, hydrocele or hypospadias repair
* Only patients booked for ambulatory surgery in the main operating room (OR)

Exclusion Criteria:

* Patients will be excluded if they have previously undergone surgery or require a translator
CyberKnife Radiosurgery for Localized Prostatic Carcinoma

Virtual high dose rate (HDR) CyberKnife (CK) prostate treatment has comparable morbidity and efficacy compared with actual prostate HDR treatment, but does it without the catheters and hospital admission. As such, it is a more "patient friendly" treatment method compared with actual prostate HDR brachytherapy as currently practiced. Related, as has previously been reported with actual prostate HDR treatment, Virtual HDR CyberKnife prostate treatment should have a high efficacy but with lower acute and chronic morbidity compared with other local prostate cancer treatment methods such as permanent seed prostate brachytherapy.

Brachytherapy is a form of treatment where a radioactive isotope is implanted directly into a tumor volume to deliver a lethal dose of radiation. High Dose Rate (HDR) Prostate brachytherapy is a particularly elegant brachytherapy dose sculpting method that is effectively used in the curative treatment of prostate cancer; however, it requires hospital admission and many temporarily implanted transperineal catheters to deliver the radiation source to the target volume, resulting in significant patient discomfort. CyberKnife delivers a form of radiation treatment that is so precise, it appears capable of reconstructing HDR prostate radiation dose sculpting, without the hospital admission and without the catheters. The CyberKnife device is also used for classic radiosurgery, with accuracy comparable to the Gamma Knife, but unlike the Gamma Knife, has the capability to target lesions anywhere in the body with similar accuracy. The aim of this study is to compare CyberKnife morbidity and efficacy with that of HDR and other local treatment methods such a permanent seed prostate brachytherapy in the treatment of prostate cancer.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed adenocarcinoma of the prostate, clinical stage T1b - T2b (AJCC 6th Edition, see Appendix II), NX/N0, M0.
* Karnofsky performance status \> 80.
* Patient must be ≥ 18 years of age.

  * Gleason Sum \< or = 7
  * Prostate-specific antigen \< or = 20 ng/ml
* Patients must sign a study-specific informed consent form prior to study entry.

Exclusion Criteria:

* Stage \< T1b, T2c, T3 or T4 disease (AJCC 6th Edition, see Appendix II).
* Gleason Score \> 7.
* PSA \> 20 ng/ml.
* Lymph node involvement (N1).
* Evidence of distant metastases (M1).
* Radical surgery for carcinoma of the prostate, prior pelvic radiation, pelvic surgical clips or other metallic foreign bodies.
* History of hormonal therapy (antiandrogen or 5 alpha reductase treatment within three months prior to treatment).
* Previous or concurrent cancers other than basal, in situ, or squamous cell skin cancers unless disease-free for ≥ 5 years.
* Major medical or psychiatric illness, which in the investigator's opinion, would prevent completion of treatment and would interfere with follow-up.
* Metallic Hip prosthesis.
* History of inflammatory bowel disease
A Proof-of-Concept Trial of GLA-SE in Patients With Merkel Cell Carcinoma

This is a single arm, open-label, single center study evaluating the safety, feasibility, clinical efficacy and immunogenicity of GLA-SE administration to patients with Merkel cell carcinoma. Ten patients will be treated. The goal is for GLA-SE to assist the patient's own immune system in attacking the cancer cells.

This is a single arm, open-label, single center study evaluating the safety, feasibility, clinical efficacy and immunogenicity of GLA-SE administration to patients with Merkel cell carcinoma. Ten patients with metastatic or locoregional disease will be treated. The goal is for GLA-SE to assist the patient's own immune system in attacking the cancer cells.

Eligibility Criteria:
Inclusion Criteria:

* Biopsy-confirmed Merkel cell carcinoma with metastatic or loco-regional disease.
* Patients must have at least one injectable lesion, defined as an easily palpable superficial lesion (cutaneous, subcutaneous or lymph nodal metastasis) that can be accurately localized, stabilized by palpation, and is superficial enough to enable IT injection.
* ECOG performance status score 0, 1 or 2
* ≥ 18 years of age
* Life expectancy of ≥ three months.
* Adequate neutrophil and platelet counts
* Adequate renal and hepatic function
* Willing to undergo pre-treatment lesion biopsy and post-treatment lesion biopsy
* Use of effective contraception
* Signed informed consent document
* Members of all genders, races and ethnic groups are eligible for this trial

Exclusion Criteria:

* Prior chemotherapy or a major surgical procedure within 3 weeks, or radiotherapy within 2 weeks prior to first study treatment
* No concurrent anti-cancer treatment (including topical agents such as imiquimod) or investigational agents
* Active, untreated brain metastases
* Pregnant or nursing
* Use of any systemic immunosuppressive agents
* Immunosuppressed patients
* Uncontrolled depression or other major psychiatric disorder