cyrilzakka/clinical-trials huggingface dataset:
Immunoscore in Rectal Cancer

This is an observational study of tumor samples and MRI imaging in patients with colorectal cancers. A tumor sample, MRI scans, and treatment outcome data will be used for research purposes to see if it is possible to predict patients' response to treatment.

The quality of the immune environment in colorectal cancer biopsy samples correlates with disease-free survival and overall survival more so than current staging conventions. This study will use a scoring system called 'immunoscore' to characterize the immune enviroment. Researchers hypothesize that the immunoscore will correlate with outcomes of colorectal patients treated with neoadjuvant chemoradiation.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of a rectal mass suspicious for or known to be an adenocarcinoma of the rectum.
* Age \> 18
* Ability to give informed consent and comply with the protocol. Patients with a history of psychiatric illness must be judged able to understand fully the investigational nature of the study and the risks associated with the therapy.

Exclusion Criteria:

* History of other malignancy in the past 2 years except carcinoma in situ of the cervix or bladder, or non-melanomatous skin cancer
* Other medical or psychiatric conditions that in the opinion of the Principal Investigator would preclude safe participation in protocol.
Periprosthetic Plate Over Humeral Nail

use of plate over humeral nail in deformity correction of femur in adult osteoporotic bone

small IM interlocking nail, such as humeral nail, could be used in femoral fixation in normal adolescent patients due to the advantages of the entry point lateral to tip of greater trochanter resulting in avoiding iatrogenic vascular injury and being the IM locking device with smaller diameter and shorter length than conventional femoral nail which was appropriate for small-sized adolescent femoral anatom

Eligibility Criteria:
Inclusion Criteria:

* Osteoporotic bone with femoral deformity.
* Osteogenesis imperfecta. --Vitamin D deficiency ricket

Exclusion Criteria:

* Uncooperative patient.

  -- Skeletally immature
* Not receiving medical treatment.
* Patient with history of allergy to drugs used in the study.
* Neuromuscular pathology, previous trauma, or surgery to the leg
L218CAR19 in Patients With Relapsed/Refractory B-cell Lymphoma

L218CAR19 is a kind of chimeric antigen receptor T-cell immunotherapy targeting CD19 on B cells. The goal of this study is to determine the safety, tolerability, pharmacokinetics, pharmacodynamics and clinical activity of L218CAR19 in patients with B-cell lymphomas who have received at least two lines of systemic treatment.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-75 years at the time of inclusion
* Written informed consent
* Patients with relapsed/refractory CD19 positive B-cell lymphomas, who have received at least two lines of treatment
* With measurable disease
* ECOG PS 0-2 at protocol entry
* Estimated life expectancy of 3 months or longer
* Hemoglobin ≥ 8 g/dL (≥5 mmol/l); Platelets ≥ 75 x 10E9/L; Absolute neutrophil count ≥ 1.0 x 10E9/L; Platelets ≥ 50 x 10E9/L permitted if documented bone marrow involvement; Serum bilirubin ≤ 1.5 x upper limit of normal (ULN), or ≤3 x ULN if elevation is due to hepatic involvement by lymphoma; Serum glutamic-oxaloacetic transaminase (AST) and/or serum glutamic-pyruvic transaminase (ALT) ≤ 2.5 x ULN, or ≤ 5 x ULN if elevation is due to hepatic involvement by lymphoma; Serum creatinine ≤ 1.5 x ULNb; left ventricular ejection fraction (LVEF) ≥ 50%
* Women of childbearing potential must use safe anticonception (e.g. contraceptive pills, intrauterine devices etc.) during the study and 6 months after the administration of study drug; Male patients must use contraception for the duration of the study and 6 months after the administration of study drug if his partner is of childbearing potential

Exclusion Criteria:

* Patients with heart disease: atrial fibrillation; History of Class III or IV New York Heart Association (NYHA) heart failure, myocardial infarction or other significant cardiac disease within 12 months of screening; LVEF\<50%; clinical significant pericardial effusion; Long QT syndrome
* History of severe pulmonary function impairment
* With other uncontrolled malignancy
* With active bacterial, viral, or fungal infections
* WIth uncontrolled autoimmune disease or congential immunodeficiency
* HIV antibody positive patients
* Known severe hypersensitivity to biological product
* Patients with known active central nervous system (CNS) disease, including lymphoma CNS involvement
* Patients with prior CAR-T therapy
* History of allogeneic stem cell transplantation
* History of autogeneic stem cell transplantation within 6 months of screening
* History of major surgery within 4 weeks of screening
* Patients receiving live (attenuated) vaccines within 6 weeks of screening
* Pregnant or lactating women, or pregnant plan within 12 months
* Involvement of cardiac tissue by lymphoma
* with emergency due to oncothlipsis
* Unwillingness or inability to comply with the protocol
* Deemed 'unfit' by the treating physician
Correction of Metabolic Disorders and Its Effect on Respiratory Function of Lungs in Patients With Severe COVID-19

Objective of the study: to investigate the effect of meglumine succinate solution on the dynamics of metabolic blood parameters and respiratory function of the lungs in intensive care patients with new coronavirus infection. An observational prospective study included 105 patients with a severe course of novel coronavirus infection


Eligibility Criteria:
Inclusion Criteria:

1. age 18-70 years;
2. diagnosis of SARS-COV-2 NCI confirmed by laboratory tests;
3. the lung lesion volume on CT scan is significant or subtotal - CT 3-4;
4. initiation of infusion therapy on the 1st day after patient admission to ICU

Exclusion Criteria:

* 1) presence of initial indications for transfer to invasive ALV at the time of screening; 2) history of Reamberin intolerance; 3) administration of other polyelectrolyte solutions with reserve alkalinity carriers; 4) pregnancy and postpartum; 5) severe renal failure requiring renal replacement therapy; 6) severe hepatic failure (Child-Pugh class C or higher); 7) diabetes mellitus; 8) terminal stage of other chronic incurable diseases
PraxbindTM India PMS Program

This program will be initiated after the commercial availability of PraxbindTM in India. It will include patients administered with PraxbindTM into the surveillance program after commercial availability in 2 years at selected centres approved by the regulatory authority.


Eligibility Criteria:
Inclusion Criteria:

- Patients treated with Pradaxa (dabigatran etexilate) capsules with requirement of rapid reversal of the anticoagulant effects of dabigatran: For emergency surgery/urgent procedures (or) In life-threatening or uncontrolled bleeding

- Written informed consent in accordance with International Conference on Harmonization Good Clinical Practice (GCP) guidelines and local legislation and/or regulations

Exclusion Criteria:

-Participation in a PraxbindTM clinical trial
Long Term Safety and Efficacy of Solesta® Injectable Bulking Agent for the Treatment of Fecal Incontinence (SoFI)

The purpose of this observational study is to evaluate the safety and effectiveness of the Solesta Injectable Bulking Agent in the treatment of fecal incontinence through 3 years in a real world setting.

This observational study is to evaluate the safety and effectiveness of the Solesta Injectable Bulking Agent in the treatment of fecal incontinence through 3 years in a real world setting.

Eligibility Criteria:
Inclusion Criteria: A patient will be eligible for study participation if he/she meets the following criteria:

* Able to fluently speak and understand the language in which the study is being conducted and able to provide meaningful written informed consent for the study.
* Have FI, have failed conservative therapy (e.g., diet, fiber therapy, medications that treat diarrhea), and are scheduled to receive Solesta treatment.
* Females must be of non-childbearing potential; or females of childbearing (reproductive) potential must agree to use an acceptable method of contraception for at least the first 6 months of study participation and have a negative urine pregnancy test at Visit 1 (Screening/Baseline) and immediately prior to receiving initial Solesta treatment. Women who are surgically sterile or those who are post menopausal for at least 2 years prior to entering the study are not considered to be of childbearing potential.
* Willing to return to the study facility for the post treatment evaluation.

Exclusion Criteria: A patient will be excluded from the study if he/she meets any of the following criteria:

* Is currently pregnant, breastfeeding, or is planning to become pregnant over the course of the study.
* Has an active inflammatory bowel disease.
* Has an immunodeficiency disorder or ongoing immunosuppressive therapy.
* Has received previous radiation treatment to the pelvic area.
* Has significant mucosal or full thickness rectal prolapse.
* Has active anorectal conditions including: abscess, fissures, sepsis, bleeding, proctitis, or other infections.
* Has anorectal atresia, tumors, stenosis or malformation.
* Has a rectocele.
* Has rectal varices.
* Has presence of existing implant including Solesta, artificial bowel sphincter, or sacral nerve stimulator (activated or inactivated).
* Has an allergy to hyaluronic acid (HA) based products.
* Has an anastomosis to the rectum or anus within 10 cm of the dentate line.
* Has an unstable condition (e.g., psychiatric disorder, a recent history of substance abuse) or otherwise thought to be unreliable or incapable of complying with the requirements of the post-approval study protocol.
* Has any disorder that, in the opinion of the Investigator, might interfere with the conduct of the study.
* Has undergone sphincteroplasty, graciloplasty, or other surgical interventions (without the use of an implanted device) for treatment of fecal incontinence within 12 months of enrollment.
* Has any bleeding disorder.
Ectoin® Mouth Wash (EML03) in the Prevention and Treatment of Radiation-induced Oral Mucositis

This prospective non-interventional comparator study is to collect data on the clinical effectiveness and compliance of Ectoin® Mouth Wash solution (EML03) and to proof superiority to a well-established medical device on the market in the prevention of radiation-induced mucositis. The study doesn´t intervene with routine treatment strategy.


Eligibility Criteria:
Inclusion Criteria:

* Individuals regardless of gender older than 18 years
* Patients diagnosed with squamous cell carcinomas \[SCCHN\] without metastases of other nonhead and nonneck tumors
* Patients receiving radiotherapy with a Karnofsky performance index \>70%
* Absence of any sign of oral mucositis at baseline (visit 1)
* A definitive or postoperative treatment
* Radiation therapy dosage: Limitation dose rate of 60-70 Gy
* Radiotherapy of 6-7 weeks duration

Exclusion Criteria:

* Subjects younger than 18 years
* Hypersensitivity to Ectoin® or any of the other ingredients of the mouth wash
* Pregnancy or breastfeeding women
* Any disease that can, in the opinion of the treating physician, affect the outcome of the observational trial
* Patients who had a history of previous radiotherapy in head-neck region or chemotherapy
* Massive alcoholic anamnesis
* Massive smoker \>20 cigarettes per day at present
A Study of LY900014 in Participants With Type 1 Diabetes Mellitus

The purpose of this study is to compare LY900014 with insulin lispro (Humalog) in participants with type 1 diabetes mellitus.

There are 2 parts to this study. Part A is investigating how the body processes LY900014 and the effect of LY900014 on blood sugar levels compared to insulin lispro (Humalog) when study treatment is given by subcutaneous injection. Part B of the study is investigating how the body processes LY900014 and the effect of LY900014 on blood sugar levels compared to insulin lispro (Humalog) when study treatment is given by continuous subcutaneous insulin infusion (CSII) pump.

Screening is required within 28 days prior to the start of the study. For each participant, the study will last about 40 days in each part.


Eligibility Criteria:
Inclusion Criteria:

* Are male or female participants aged 6-64 with Type 1 Diabetes Mellitus (T1DM) for at least 1 year
* Have a glycated hemoglobin (HbA1c) less than (\<)10.0 percent (%)

Exclusion Criteria:

* Receiving any oral or injectable medication intended for the treatment of diabetes mellitus other than insulins in the 12 months prior to screening
* More than one episode of severe hypoglycaemia in the last 6 months
* Presence of clinically significant hematologic, oncologic, renal, cardiac, hepatic, or gastrointestinal disease, proliferative retinopathy, uncontrolled celiac disease, uncontrolled hyperthyroidism or hypothyroidism, or adrenal insufficiency
* Have obvious clinical signs or symptoms of liver disease
* Have a history of renal impairment
Safety and Pharmacokinetic Study of Lumacaftor/Ivacaftor in Participants 1 to Less Than 2 Years of Age With Cystic Fibrosis, Homozygous for F508del

This study will evaluate the safety and pharmacokinetics (PK) of lumacaftor (LUM) and ivacaftor (IVA) in participants 1 to less than 2 years of age with cystic fibrosis (CF), homozygous for F508del (F/F).


Eligibility Criteria:
Key Inclusion Criteria:

* Participants will be 1 to less than 2 years of age on day 1 of the relevant part of the study
* Homozygous for F508del (F/F)

Key Exclusion Criteria:

* Any clinically significant laboratory abnormalities at the screening visit that would interfere with the study assessments or pose an undue risk for the participants
* Solid organ or hematological transplantation

Other protocol defined Inclusion/Exclusion criteria may apply.
Safety and Efficacy of Zuretinol Acetate in Subjects With Inherited Retinal Disease

To evaluate the efficacy of ZA oral solution in subjects with IRD caused by biallelic recessive RPE65 or LRAT gene mutations and phenotypically diagnosed as Leber's Congenital Amaurosis (LCA) or Retinitis Pigmentosa (RP).


Eligibility Criteria:
Inclusion Criteria:

1. Have read, understood and signed the informed consent form (ICF).
2. Be aged 6 years or older.
3. Have a diagnosis of IRD phenotypically diagnosed as LCA or RP by an ocular geneticist or ophthalmologist and caused by pathologic biallelic autosomal recessive mutation in RPE65 or LRAT as determined by a fully accredited certified central genotyping laboratory.
4. Be naïve to gene therapy, surgical implantation of prosthetic retinal chips, or subretinal injections.
5. If previously administered ZA , have at least \> 3 years since last administration of ZA.
6. Pregnancy testing and contraception before study treatment: Women of childbearing potential must not be pregnant or lactating.

Exclusion Criteria:

1. Have a presence of concurrent ocular disease that in the opinion of the Investigator would put the subject at greater risk during the study or significantly affect study results.
2. Have had ocular surgery within 3 months of Screening, including cataract or laser procedures.
3. Have taken any prescription or investigational oral retinoid medication (e.g., isotretinoin or acitretin) within 6 months of Screening; subjects who did not tolerate their previous oral retinoid medication will be excluded regardless of the time of last exposure.
4. Have taken any supplements containing ≥ 10,000 IU vitamin A within 60 days of Screening.
5. Have taken any medication that affects bone metabolism within 6 months of Screening.
6. Have circulating 25-hydroxy vitamin D \< 20 ng/mL.
7. Use of medications that may interact with a retinoid, including tetracycline, ketoconazole and methotrexate within 60 days of Screening.
8. Use of intraocular or periocular corticosteroids within 90 days of Screening; use of corticosteroid implants within 3 years of Screening; use of systemic corticosteroids unless these are at a steady low dose with low dose level in effect prior to or at Screening; or use of intraocular or periocular anti-vascular endothelial growth factor agents within 2 months of Screening.
9. Have a known and documented allergy to soy.
Prediction of Sepsis After Flexible Ureteroscopy

Sepsis is a lethal complication of flexible ureteroscopy. The aim of this study is to identify predictors of sepsis after flexible ureteroscopy in patients with solitary proximal ureteral stones.


Eligibility Criteria:
Inclusion Criteria:

* history of fURS to treat unilateral, solitary, and proximal ureteral stones
* age ≥18 years

Exclusion Criteria:

* anatomical renal abnormalities such as transplant kidney, solitary kidney, horseshoe kidney, and kidney duplication
Female Chronic Pelvic Pain

The purpose of this study is to investigate the frequency and severity of chronic pelvic pain (CPP) in adult women living in Copenhagen Country and Zealand Country (total population 2,4 million), Denmark, in relation to selected factors, such as basic demographic and clinical factors, health related quality of life, physical activity and abnormal muscular findings in the pelvic area.

Introduction:

The aim of this study is to investigate the frequency and severity of chronic pelvic pain (CPP) in adult women living in Copenhagen Country and Zealand Country (total population 2,4 million), Denmark, in relation to selected factors, such as basic demographic and clinical factors, health related quality of life, physical activity and abnormal muscular findings in the pelvic area.

Methods:

The study is designed as a cross-sectional, questionnaire-based survey and two randomly selected age stratified groups of the responding participating women, one with or one without pain, will receive a clinical examination by a specialist physiotherapist for abnormal muscular finding in the pelvic, lower abdominal or inguinal area.

Results:

Descriptive characteristics will be obtained by univariate analysis and presented as means with standard deviations, or percentages. T test and the Mann-Whitney test will be used to analyze continuous data with and without normal distribution, respectively, and the Chi-square test or Fisher's exact test will be used to analyze categorical data, as appropriate. Correlation between self-reported CPP and abnormal muscular findings will be analysed. Logistic regression analysis will be used to identify the independent variables significantly associated with CPP. For logistic regression analysis, we will select only those findings that are significant as determined by Fisher's exact or the Chi-square test, with values of 0 and 1 assigned to the absence and presence, respectively, of each variable in each subject.

Eligibility Criteria:
Inclusion Criteria:

* Women ≥ 18 years
* Living in Copenhagen Country (Region H)
* Capable of reading, writing and speaking Danish

Exclusion Criteria:

* Pain limited solely to the perineal skin or introitus (vulvodynia)
* Pregnancy, cancer, active pelvic inflammatory disease
* Operation in the pelvic during the last 6 months
* Cognitively impaired individuals
Perioperative Stress Management in Outpatient Surgery With L-tyrosine Supplementation (SPOT)

Patient undergoing surgery is exposed to many stressors: diachronic (gesture anticipation), synchronic (intraoperative aggression) and historical (subject's personality). Reducing the level of stress experienced is a factor for improving the quality of the surgical gesture and the simplicity of the follow-up. The previous methods used were intended to reduce the body's reactivity to aggressions through anaesthesia consultation and L-Tyrosine supplementation. Currently with the progression of outpatient surgery and the need for early rehabilitation, L-Tyrosine supplementation is suppressed to improve recovery. Some patients, however, have a high level of stress that may require anxiolysis when the ideal treatment does not exist (ineffective hydroxyzine, benzodiazepines having many side effects). The strategy of this work is to improve the body's ability to respond to stressors, by administering l-tyrosine with no impact on waking or returning home.


Eligibility Criteria:
Inclusion Criteria:

* Membership of a social security scheme or equivalent
* At least 18 years of age
* Able to express consent
* Indication of unilateral or bilateral inguinal hernia cure
* General anaesthesia proposed and retained for inguinal hernia treatment regardless of surgical technique

Exclusion Criteria:

* Surgical indication for another reason or hernial cure associated with another procedure
* Smoking estimated at more than 35 pack-years
* History of psychiatric pathology
* ASA 3 or 4 according to the American Society of Anesthesiologists classification. As a reminder, an ASA 3 class concerns a patient with a severe but not disabling general disease, and an ASA 4 class concerns a patient with a disabling general disease involving the vital prognosis.
* ASA 2 and having at least one of the following pathologies or patients treated with -blockers: insulin-dependent diabetes, high blood pressure, heart rhythm disorder, dysthyroidism, progressive neurological disease, long-term benzodiazepines.
* Starch allergy or intolerance
Focused Cognitive Testing in Inpatients

Neurocognitive Disorder (NCD) affects over 116'000 people in Switzerland and is frequently unrecognized and underdiagnosed. Because missed and delayed diagnosis are associated with an increased burden of disease health Service Research has prompted a discussion about diagnostic guidelines and screening programs. Some argue that screening for NCD in primary care is the optimal strategy to increase recognition rates; others consider test protocols implemented into hospital admission assessments as more justified. There is no distinct recommendation due to a lack of empirical data on the benefits and harms of cognitive testing yet. This trial strives to fill this gap and provide information about the benefits, harms and the economic case of routine cognitive testing for neurocognitive disorder in high risk elective inpatients, in Switzerland.

The investigators hypothesize that, cognitive tested patients, compared with patients not cognitive tested, will have higher health-related quality of life at 12months; and lower medical health care costs at 18months.


Eligibility Criteria:
Inclusion Criteria:

* Elective inpatients, living in the canton of lucerne, high risk of developing a major neurocognitive disorder, living at home

Exclusion Criteria:

* Known mental disorder according to ICD-10, chapter V, excluding F32 \& F33, patients with terminal illness, patients of intensive care unit or oncology patients, no adequate vision or hearing, no ability to speak, write or to understand German, no Informant, antidementia medication