cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Patient Management for Lymphoma Diagnosed at Nimes University Hospital From 1999 to 2018. DVR-Lym-Nim

Observation of a cohort of 400 patients with different types of lymphomas.

A database on 400 patients diagnosed with lymphomas was built up over 20 years at Nîmes University Hospital. Biopsies were made on these tumours and all the samples were frozen.

Considering the heterogeneous nature of lymphomas, randomized clinical trials based on very precise criteria for the inclusion or non-inclusion of patients are the gold standard for studying the various sub-types of lymphomas by concentrating on homogeneous populations for which a limited number of parameters are analyzed simultaneously. However, due to the complexity of their medical situation, many patients may be excluded form these trials, thus making it difficult to obtain reliable results.

The analysis of a non-selected cohort has two main advantages: (1) to better understand the diversity of patients with lymphomas for which the recommendations are constantly evolving and (2) to analyze how, exactly, these are managed by integrating points which are currently poorly evaluated such as comorbidities and accessibility to treatment.

The aim of the study is to describe how these patients are managed and to demonstrate that not all patients are able to benefit from the official management recommendations applicable to their pathology.

Eligibility Criteria:
Inclusion Criteria:

* Patients over the age of 15 years and 3 months, diagnosed with lymphoma at Nîmes University Hospital as from 1999 onwards and for whom diagnostic tumor material is available.

Exclusion Criteria:

* Patients aged 18 or over who have expressed their desire not to take part in the study.
* Patients under the age of 18 whose legal representatives have expressed their desire for the child not to take part in the study.
* Patients under legal guardianship.
Relaxation Music to Lower Heart Rate Prior to Cardiac CT

To acquire low radiation dose and good quality cardiac CT images requires scanning at low heart rates which is usually done with beta-blockers. However, in some patients beta-blockers have little effect. This is thought to be due to a different mechanism of action which continues to maintain the heart rate despite administration of beta-blockers. This study aims to look at the effect of music or relaxation tracks to reduce patient heart rate as anxiety is thought to play a role in maintaining high heart rates. This study will randomise patients into a normal standard of care group compared to a normal standard of care group with music/ relaxation track and compare heart rate, radiation dose, image quality, amount of beta-blocker used and patient experience via a State-Trait Anxiety Inventory (STAI) questionnaire.


Eligibility Criteria:
Inclusion Criteria:

* Age: 18 years and above
* All patients coming in for non-contrast enhanced calcium score CT, pulmonary vein angiogram, or coronary CT Angiogram

Exclusion Criteria:

* Deaf
* CT for Transcatheter aortic valve implantation (TAVI) or congenital heart disease patients
* Poor english literacy
* Pacemaker
* Post CABG
* Post heart transplant
Description of Relugolix Use in Patients With Prostate Cancer Within the VHA

The purpose of this real-world study is the learn about the demographics and clinical characteristics of patients with prostate cancer who initiated relugolix

Prostate cancer (PC) is the most common cancer and the second leading cause of cancer death among men in the United States. Androgen deprivation therapy (ADT) such as injectable luteinizing hormone-releasing hormone (LHRH) agonists (e.g., leuprolide) is the standard of care for PC patients. ADT treatment can suppress testosterone level to castrate level and delay the progression of the disease.

Relugolix is a recently approved oral GnRH antagonist. While the introduction of relugolix has offered a unique opportunity for patients with PC, it's vital to understand how it is being used in real-world.

Eligibility Criteria:
Inclusion Criteria:

* Male with ≥ 1 diagnosis for PC
* Had ≥ 2 prescriptions of relugolix on or after the first observed PC diagnosis.
* Index date: the initiation date of relugolix
* At least 18 years old at the index date

Exclusion Criteria:

* had surgical castration (bilateral orchiectomy) any time before the index date
Weekly Docetaxel and Fixed-Dose Rate Gemcitabine Combination Chemotherapy

To determine the activity of weekly Docetaxel and Gemcitabine in patients with advanced soft tissue sarcoma previously treated with anthracycline and/or ifosfamide

1. Primary endpoint: response rate
2. Secondary endpoint: progress-free survival, overall survival, safety


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed recurrent or metastatic, unresectable soft tissue sarcoma or bone sarcoma with the exception of certain histopathologic subtypes of sarcomas recognized by experts to derive no benefit from conventional chemotherapy (e.g., alveolar soft part sarcoma, clear cell sarcoma, chondrosarcoma, chordoma, desmoid tumors)
* Bone sarcoma patients must have visceral metastatic disease (e.g., metastatic to lung or liver)
* Patients who were previously treated with anthracycline- and/or ifosfamide- containing chemotherapy, as a first-line chemotherapy for metastatic disease, or adjuvant therapy Patients may have had up to 2 prior chemotherapies within 4 weeks of starting the study treatment
* unidimensional measurable lesions
* Age ≥ 16 years
* Life expectancy of more than 3 months
* ECOG performance status ≤ 2
* Adequate bone marrow function (ANC≥1,500/mm3, and platelet count ≥100,000/mm3)
* Adequate kidney function (serum creatinine ≤ 1.5 mg/dL)
* Adequate liver function (bilirubin ≤ 2 mg/dl and transaminase level ≤ 3 times the upper normal limit, or \< 5 times for patients with liver metastasis, serum alkaline phosphatase \< 2.5 times the upper normal limit, or \< 5 times if liver metastases were present or \< 10 times if bone metastases were present).
* Adequate cardiac function (Ejection fraction ≥ 50% by echoCG or MUGA scan)
* All patients are fully informed about the nature and purpose of this study and should give informed consent before the start of treatment.

Exclusion Criteria:

* Pregnant or lactating patients
* Patients with resectable lung metastasis
* Presence or history of CNS metastasis
* Prior history of other cancer within past 5 years, asides from basal cell and squamous cell carcinoma of skin, and carcinoma in situ of uterine cervix
* Any preexisting medical condition of sufficient severity to prevent full compliance with the study.
A Study of APS03118 in Advanced Solid Tumors Harboring RET Mutations or Fusions

This is a Phase 1, open-label, first-in-human (FIH) study designed to evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary antineoplastic activity of APS03118 administered orally in participants with RET-altered solid tumors.

After being informed about the study procedure and potential risks and benefits, all patients giving written informed consent will undergo a 4-week screening period to determine eligibility for study entry. The eligible participants will be enrolled using a rolling 6 dose escalation scheme to identify MTD and/or RP2D.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients aged 18 years or older
2. Have histological or cytological confirmation of unresectable locally advanced or metastatic solid tumors harboring oncogenic RET mutations or fusions confirmed by NGS. Site may identify patients with a RET-mutated or RET-fusion solid tumor before the formal screening.
3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
4. Resolution of all toxic effects of prior therapies to Grade 1 or below according to NCI CTCAE version 5.0 (except alopecia or Grade 2 neuropathy);
5. Patients with asymptomatic brain metastases if they have been previously treated, demonstrated no progression at least for 1 months before Screening, are asymptomatic and have had no requirement for steroids or enzyme inducing anticonvulsants in the last 14 days before Screening
6. Adequate organ function

Exclusion Criteria:

1. Have a locally advanced solid tumor that is a candidate for curative surgery treatment through radical surgery and/or radiotherapy.
2. Have an active fungal, bacterial, and/or active untreated viral infection
3. The patient has a serious pre-existing medical condition(s)
4. Have received or will receive a COVID-19 vaccine within 1 month before the first dose of APS03118.
Efficacy Study of Pharmacist Intervention on Medication-related Problems in Hemodialysis Patients

The investigators propose that pharmacist interventions would reduce the amount of unresolved medication-related problems in hemodialysis patients.

Condition:Hemodialysis patients

Intervention:Behavioral,Pharmacist intervention

Study Design:Randomized Allocation

Control: Active Control

Endpoint Classification: Efficacy Study

Intervention Model: Parallel Assignment

Masking: Double Blind (Caregiver, Outcomes Assessor)

Primary Purpose: Treatment

Introduction:

End stage renal disease (ESRD) incidence in Taiwan ranked first and prevalence ranked second in the world from 2002 to 2005. Several foreign researches had reported that hemodialysis (HD) patients often require 12 medications to treat 5 to 6 comorbid conditions. Besides, ESRD is a lifelong disease and rates of compliance may diminish overtime. Thus, HD patients may be at particular risk for drug related problems, durg-drug interactions and noncompliance. Our aim is to analysis the effect of pharmacist in medication-related problems in ambulatory hemodialysis patients.

Methods:

This study is a randomized double-blind, active controlled trial. The investigators will invite and communicate with HD patients to find medication -related problems. After pharmacist evaluation, pharmacist will do pharmaceutical interventions to resolve medication-related problems, drug-drug interactions etc. in experimental group. In the active control group, pharmacist in this study will not do pharmaceutical interventions. The investigators will monitor each patient in a two-week period for medication-related problems.

Our primary outcome is the amount of unresolved medication-related problems in each group after two weeks. Blind outcome assessor will evaluate the amount of unresolved medication-related problems in each case as well as compliance in these patients after two weeks.

The investigators suppose that clinical pharmaceutical intervention will reduce the amount of unresolved medication-related problem in experimental group. On the other hand, patients without clinical pharmaceutical intervention will have more unresolved medication-related problems.

Eligibility Criteria:
Inclusion Criteria:

* 20-96 years old hemodialysis patient taking medications prescribed by nephrologists.

Exclusion Criteria:

* Patients who refused informed consent
* Cognitive impaired
* unable to talk or hearing disability
Congenital Anomalies in Infants of Diabetic Mother

The purpose of this study was to determine the pattern of congenital anomalies associated with maternal diabetes mellitus in newborns attending Assiut University children's Hospital.

Infants of diabetic mothers have been shown in several studies to have an increased frequency of malformations. In previous studies, an increased frequency of several specific malformations has been noted, including anencephaly, bilateral renal agenesis, and double outlet right ventricle. Surveillance, used to identify all malformed infants in a consecutive sample of births, can identify a distinctive pattern of malformations among the affected infants.(1) Maternal pregestational diabetes mellitus is associated with an increased risk for congenital malformations of about2-4 times the background risk.(2) Perinatal outcome of the infant of the diabetic mother (IDM) depends on the onset, duration, and severity of maternal diabetes and is worse for IDM born from mothers with pre-existent insulin-dependent diabetes.(3) that glycemic control is associated with a reduced risk of congenital anomalies. However, the recommended threshold of HgA1c for pregestational diabetic women planning pregnancy is still not known.(4) Congenital anomalies are broadly classified into either single-system or multiple-system malformations. The first type affects a single organ system or body part,(5,6,7) and the second affects more than one organ system or body part. Major congenital anomalies are defined as those that, if uncorrected, could result in considerable impairment of the normal body functions or even reducing the life expectancy. Minor congenital anomalies include the anomalies that cause no disability or have no significant physical or functional effects and can be regarded as normal variants.(5,8,9) In another study conducted in Egypt on live-born babies, the incidence of minor congenital anomalies among infants of diabetic mothers was 18%, while the incidence was 11% for the major congenital anomalies, the later was 4.6 times higher than in the general population.(10) The pathophysiology of maternal diabetes induced birth defects is complex, however, clearly relates to maternal glucose levels. The mechanism is not entirely understood, but animal studies have shown it to be associated with decreased cell proliferation and increased cell apoptosis due to high oxidative stress, the second major change is altered gene expression causing deviation from the normal developmental process.(11) However, most congenital defects associated with diabetes occur in the cardiovascular, central nervous and musculoskeletal systems. Although hyperglycemia is a common mechanism for teratogenicity, differences in disease characteristics, such as age of onset, ethnicity, obesity and duration of disease, may affect the disease impact on the perinatal outcome and the rate of congenital anomalies.(11,12)

Eligibility Criteria:
Inclusion Criteria:

* The study will include all births of diabetic mothers

Exclusion Criteria:

* Other risk factors of congenital anomalies, such as TORCH infections, teratogenic drugs or irradiation.
STAMP+CBT mHealth for Cancer Pain

The purpose of this study is to test whether a mobile application developed to help people with cancer pain is useful and helpful to patients with cancer.

This research study involves the use of a smartphone app at home in addition to surveys and potentially an interview at the end of the study.

The research study procedures include screening for eligibility, study interventions include surveys at the beginning of the study, after 4 weeks, and after 6 weeks and use of the smartphone app.

Participants will be on this research study for up to 6 weeks.

It is expected that about 15 people will take part in this research study

This research study is a Feasibility Study, which is the first-time investigators are examining this mobile application meant to help participant to learn behavioral techniques to manage cancer pain. The purpose is to make sure the app is usable and helpful for patients with cancer, and to get feedback about patient experiences after using the app for four weeks.

Eligibility Criteria:
Inclusion Criteria:

- PILOT COHORT

* Age ≥ 18 years
* Patients diagnosed with an active cancer diagnosis, either undergoing active cancer treatment or receiving treatment for an advanced cancer or are receiving palliative care
* Treatment managed at participating clinic (DFCI outpatient palliative care, gastrointestinal cancer center, and DFCI satellite clinic Merrimack Valley or Londonderry)
* Chronic pain related to cancer or treatment (\> pain score of 4)
* Has an active prescription for at least one opioid medication to treat their cancer pain (i.e. not for post-surgical pain)
* Own a compatible smartphone (android) or is willing to use an android device provided by the study team
* Completes baseline survey

Exclusion Criteria:

* Patients in survivorship: patients who have completed their treatment regimens, are not actively receiving treatment for an advanced cancer, or have a cancer that is in remission
* Cognitive impairment that would interfere with study participation, as judged by treating clinician
* Inability to speak English: the intervention has not yet been translated to Spanish
* History of opioid use disorders
* Enrolled in hospice
* Currently hospitalized
* Use of transmucosal fentanyl, given safety concerns and ongoing risk mitigation program required to prescribe these (TIRF REMS).
* Pain primarily related to a recent surgery
EVALUATION of CATS TONOMETER PRISM in LASIK SUBJECTS

The CATS Tonometer prism clinical study is intended to determine repeatability of intraocular pressure measurement in human corneas which have undergone a LASIK procedure when compared to a standard Goldmann prism, validating the human LASIK eye findings comparing CATS Tonometer and Goldmann prisms to intracameral pressure in cadaver eyes.


Eligibility Criteria:
Inclusion Criteria:

Subjects must meet the following inclusion criteria to be eligible to participate in this clinical trial:

* At least 22 years of age and undergone LASIK treatment
* Subject has a clear understanding, English speakingand agrees to all the conditions of the informed consent form

Exclusion Criteria:

* Subjects will be excluded from participation if they meet the following criteria:

  * Subject has undergone ocular surgery within the last 3 months or LASIK within 6 months
  * Pregnant or nursing women
  * Those who have had previous corneal surgery excluding LASIK
  * Keratoconus
  * Corneal scarring
  * Microphthalmos
  * Buphthalmos
  * Dry eyes with clinical epithelial breakdown upon exam
  * Lid squeezers - blepharospasm
  * Nystagmus
  * Corneal or conjunctival infection.
Corneal Topographer Fluorescein Patterns

The objective of this study is to determine if corneal topography can be used to predict the fluorescein pattern of keratoconus lenses on the eye. A corneal topography image will be taken and the computer selected lens will be placed on the eye. After placement of the lens color photographs will be taken of the eye's fluorescein pattern and compared to the computer predicted pattern.

Subject population: keratoconus patients who have not undergone corneal surgery 100 subjects who come to UIHC for their contact lens care. We will approach them at their visit. We will not call potential participants from a database.

If topography is impossible to capture. Concommitant Corneal Disease Minors will be excluded

Eligibility Criteria:
Inclusion Criteria:

18 yrs of age or older with diagnosis of keratoconus and contact lens wearer

Exclusion Criteria:

Noncommittant corneal disease or surgery Inability to capture topography measurement
Neovaginoplasty Using Photoinduced-imine-crosslink Hydrogel in MRKH Patients

Evaluating the effectiveness and safety of neovaginoplasty using photoinduced-imine-crosslink hydrogel in patients with MRKH syndrome by comparing the differences in the degree of squamous epithelialization, vaginal length and width, and sexual life quality.

This is a randomized controlled trial. Patients meeting the inclusion criteria will be enrolled in this study: 1)Diagnosed with MRKH syndrome; 2)Without previous treatments; 3)Age: 18-35 years old; 4)Voluntary agreement to participate in the study, sign the informed consent form, and demonstrate good compliance with follow-up.

A centralized block randomization will be used to randomly assign patients to ensure that there will be an equal number of patients (1:1) in the hydrogel group and control group. The sample size is 20.

Under general anesthesia and catheterized bladder, the patient was in the lithotomy position. In the connective tissue plane between the bladder and rectum, the vestiges of the müllerian ducts were identified. With the index finger in the rectum as a direction and protection, Hegar's dilators of increasing size (4.5-10) were pushed through the dimples gently. After that, a double-barreled canal appeared. Then, the raphe between the canals was incised. The neovagina was created. According to the randomization, a vaginal mold spreaded with hydrogel or not was placed. The patients were suggested to wear the vaginal mold continuously over the following 6 months. After that, they were allowed to have the first sexual intercourse. Otherwise, the mold wearing time was 1 h daily, until they had sexual activity at least twice a week.

The primary endpoint is the degree of vaginal squamous epithelialization 1 month, 3 months, 6 months after surgery. The secondary endpoints include neovaginal length and width, sexual life quality, and surgical complications.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed with MRKH syndrome;
2. Without previous related treatments; 3)18-35 years old;

4)Voluntary agreement to participate in the study, sign the informed consent form, and demonstrate good compliance with follow-up.

Exclusion Criteria:

1. With any previous artificial colpoplasty or other related treatment;
2. With history of diabetes or systemic immune system disease.
Prevalence of Lymphedema in Valle Del Cauca, Colombia.

This is an epidemiological cross-sectional study aiming to determine the prevalence of lymphedema and the incidence of risk factors in patients diagnosed with unilateral breast cancer in a cohort from 2008 to 2020 in a specialised oncology centre in Valle del Cauca, Colombia.

CONTEXT: Breast cancer-associated lymphedema is considered one of the most frequent side effects of breast cancer therapy. (1,2) Despite the abundant information available worldwide on epidemiology and risk factors, little is known about these data in Colombia and Latin America.

OBJECTIVE: To determine the actual prevalence and incidence of risk factors for the development of lymphedema associated with breast cancer in a specialised oncology centre in Valle del Cauca, Colombia.

DESIGN, SETTING, AND PATIENTS: Between 2008 and 2020 a sample of 367 patients with a diagnosis of unilateral breast cancer was established, with which a descriptive study was carried out, in which a series of anthropometric measurements were taken of the upper limbs in order to obtain the volume of both arms and determine the prevalence of lymphedema using the formula of truncated volumes of the Spanish society of lymphology, after which the medical records were reviewed in order to collect other data of interest. Patients were excluded if they had bilateral breast cancer or direct trauma to the upper limb.

INTERVENTIONS: A single intervention was carried out in which the patients were summoned for an interview and anthropometric measurements of the upper limbs, thus calculating the arm volume for a lymphedema primary diagnosis .

Eligibility Criteria:
Inclusion Criteria:

* Unilateral breast cancer, cancer diagnosis between 2008-2020 in the oncology institution Colombia

Exclusion Criteria:

* Moving to a different institution for attention (other than Hemato-Oncólogos SA), unwillingness to become volunteer and death, bilateral breast cancer, congenital disease or trauma in the upper limb.