cyrilzakka/clinical-trials huggingface dataset:
A Safety and Antitumor Activity Trial of Immunoradiotherapy Combinations as a Treatment Option for Subjects With Metastatic Solid Tumors

The main purpose is to assess the safety and clinical activity of GEN1042 in combination with radiotherapy or GEN1042 in combination with radiotherapy and pembrolizumab as a treatment option for participants with metastatic solid tumors.

The study will be conducted in two parts: Part 1 (dose-finding) and Part 2 (randomization).

Part 1 will evaluate the safety of immunoradiotherapy combinations and establish the dose(s) to be evaluated in Part 2.

Part 2 will evaluate the anti-tumor activity of immunoradiotherapy combinations at the established dose(s) from Part 1.

Participants in both parts are treated with one of the following combinations:

* Radiotherapy + GEN1042
* Radiotherapy + GEN1042 + Pembrolizumab

While participants in Part 1 are assigned sequentially (GEN1042 without pembrolizumab is investigated first), participants in Part 2 are randomized 1:1 in the two treatment arms.

Eligibility Criteria:
Key Inclusion Criteria:

* Participants with histologically confirmed non-central nervous system (CNS) solid tumor that is metastatic and for whom there is no available standard therapy.
* At least 18 years of age.
* Signed informed consent prior to any screening procedures.
* Measurable disease according to RECIST v1.1.
* Life expectancy of \>3 months.
* Qualify for palliative radiotherapy as an available option for disease management.
* Eastern Cooperative Oncology Group (ECOG) 0-1.
* Normal or adequate liver, renal, cardiac and bone marrow function.

Key Exclusion Criteria:

* Prior malignancy except for non-melanoma skin cancers and in situ cancers.
* Condition contraindicating radiotherapy.
* Rapidly progressing disease.
* Active, known or suspected autoimmune disease.
* History of non-infectious pneumonitis that required steroids or currently has pneumonitis.
* Contraindications to the use of pembrolizumab.
* Condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of first treatment.
* Received an allogeneic tissue/solid organ transplant.
* Active infection requiring systemic therapy.

Note: Other protocol defined inclusion and exclusion criteria may apply.
A Study to Evaluate the Efficacy and Safety of HCP1004 in Chronic Low-Back Pain Patients

A Randomized, Double-blind, Active-controlled, Non-inferiority, Multicenter Phase III Study to Evaluate the Efficacy and Safety of HCP1004 as compared to RLD2401 in Chronic Low-Back Pain Patients


Eligibility Criteria:
Inclusion Criteria:

1. Chronic low back pain ≥3 months in duration
2. Quebec Task Force in Spinal Disorders class 1 or 2
3. Male or female ≥ 19 years of age with following criteria:

   * ≥ 50 years
   * 19\~ 49 years with history of gastric or duodenal ulcers within the past 5 years
   * Low back pain disease condition expected to require daily NSAIDs therapy for at least 12 weeks
4. VAS ≥ 40 (at Visit 2) (If there are any treatment history to affect the efficacy evaluation of low back pain, VAS after washout period have to meet the criteria; 20% over baseline VAS or change from baseline VAS ≥10)

Exclusion Criteria:

1. Diagnosed with certain serious diseases that may be secondary causes of Low back pain (e.g., tumors, infectious diseases, gout, etc.)
2. Clinically significant neurological disease or low back pain due to trauma (e.g. spinal fracture) within the past 6 months
3. Invasive procedures (using corticosteroids) in the lumbar region within the past 3 months or surgical intervention within the past 6 months or need to such interventions during the study
4. History of non-drug treatment of the lumbar region (e.g., physical therapy) for the purpose of alleviating low back pain within 7 days prior to the screening visit.
5. Active gastritis, inflammatory bowel syndrome, peptic ulcer or any history of gastrointestinal bleeding duodenal ulceration within the past 3 months
6. Patients with history of platelet-related disease or bleeding disorder within the past 6 months or who are taking anti-coagulants
7. Patients with ischemic heart disease or severe cerebrovascular disease within the past 6 months
8. Bronchial asthma or Uncontrolled Diabete Mellitus or Hypertension
9. Use of peptic ulcer treatment (H2-blockers, PPI, PCAB series or Misoprostol), psychotropic drugs, narcotic analgesics or systemic corticosteroids within past 4 weeks
10. Severe renal dysfunction (Creatinine clearance ≥ 30mL/min ) or Severe liver dysfunction (AST or AST ≥ 3 x UNL)
11. History of malignant tumors within past 5 years
12. Positive to pregnancy test, nursing mother, intention on pregnancy
13. Considered by investigator as not appropriate to participate in the study with other reason
Development of an Artificial Intelligence Model for the Identification and Prevention of Smoking-related Diseases.

The study is an interventional pilot study. The study is designed to be monocentric and it presents additional procedues.

Interventional pilot study, single-center with additional procedures, such as completion of EORTC-QLQ-LC29, EORTC-QLQ-C30 questionnaires, motivational test, Fagestrom test, anamnestic questionnaire, spirometry, measurement of carbon monoxide, Low-dose spiral computed tomography without contrast medium, peripheral venous blood sampling for a volume of 20 ml.

The study has the main objective of traininig and validate a reliable and unbiased Artificial Intelligence (AI) algorithm that detects the presence of nodules and differentiates between malignant or benign tumor types.

The study considers patients with suspected diagnosis or with a dignosis of lung cancer, smokers and former smokers over 50 years of age at high risk of lung cancer and subjects enrolled in previous screening cohorts at this Institute.

Eligibility Criteria:
High-risk screening subjects

Inclusion Criteria:

* Age \>= 50 years old
* Active smokers
* Former smokers (from no more than 15 years)
* Pack/year \>20
* Risk-prediction model from Prostate, Lung, Colorectal, and Ovarian study (PLCOm2012) \>1.2%
* Provision and signature of informed consent

Exclusion Criteria:

* Previous or concurrent neoplastic disease, excluding skin cancers
* Cognitive or other problems that could hinder the collection of informed consent
* Severe pulmonary or extra pulmonary disease
* Previous low-dose computed tomography (CT) scan in the past 12 months

Previous high-risk positive screening subjects

Inclusion Criteria:

* Subjects enrolled in previous lung cancer screening with the presence of lung nodules \>4 mm and candidate to additional computed tomography (CT)
* Signed informed consent

Exclusion Criteria:

- None

Previous high-risk negative screening subjects

Inclusion Criteria:

* Subjects enrolled in previous lung cancer screening in this Institute with negative computed tomography (CT)
* Signed informed consent

Exclusion Criteria:

- None

Lung Cancer patients

Inclusion Criteria:

* Patients with diagnosis or suspicious diagnosis of lung cancer candidate to surgical treatment or already submitted to it
* Patients with diagnosis of lung cancer treated with surgical resection
* Signed informed consent

Exclusion Criteria:

* computed tomography (CT) scans not available at San Raffaele Hospital
* Previous neoadjuvant treatment
Efficacy and Safety of Paclitaxel-eluting Balloon for Treatment of Lesions in Native Small Coronary Arteries

The purpose of this study is to evaluate the efficacy and safety of paclitaxel-eluting balloon (SeQuent® Please) for treatment of lesions in native small coronary arteries.

Drug-eluting balloon (DEB) have emerged as a potential alternative to overcome the limitations of drug-eluting stents such as restenosis or stent thrombosis.

DEB angioplasty is proven to be effective clinically for the treatment of in-stent restenosis. However, DEB for de novo lesions, especially in small vessels is less studied.

The purpose of this study is to evaluate the efficacy and safety of paclitaxel-eluting balloon (SeQuent® Please) for treatment of lesions in native small coronary arteries.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 19 years
* Patients who are appropriate for percutaneous coronary intervention using drug-eluting balloon in native small coronary artery (vessel diameter ≥ 2.25 mm and ≤ 2.75 mm, lesion length \< 25 mm)
* Informed consent

Exclusion Criteria:

* Chronic total obstruction lesion
* Severe calcified lesion
* Left main coronary lesion
* Lesion having intravascular thrombus
* Shock status from any cause including cardiogenic shock
* Left ventricular ejection fraction \< 30%
* Need for coronary artery bypass surgery
* Allergic reaction for paclitaxel
* Severe allergic for contrast agent (Visipaque) or statin
* Pregnancy, breastfeeding or Expectation for pregnancy in women of childbearing age
Online Mother-Baby Yoga With Preterm Infants and Their Mothers

The purpose of this study is to examine the effects of internet-based mother-baby yoga on preterm infants and their mothers.

Mother-infant pairs were enrolled in the study. Interventions applied as group sessions (maximum of 5 mother-infant pairs) for 6 weeks, once a week. Yoga sessions Before-after evaluations were done for both mother and infant outcomes.

Eligibility Criteria:
Inclusion Criteria:

* The infants whose gestational age between 32 0/7-36 6/7 week and corrected age's older than 6 weeks and their mothers
* Caregivers who have at least one smartphone or/and laptop or/and Ipad
* Mothers and their babies who accept to register to the study

Exclusion Criteria:

* The infants who have a severe pathological sign in cranial screening
* The infants who had IVH
* The infants who have congenital abnormalities
* The infants who have a metabolic or genetic diagnosis
* The infants who have hearing or visual impairment
* The mothers who had chronic depression history and/or mental retardation
* The mothers who have a neurological or orthopedic diagnosis to the contraindication of exercise
* The mothers who are pregnant
The Anaesthesiological Approach to Varicocele Correction in Outpatients Setting: an Observational Analysis

The aim of this observational study was to evaluate, based on the intraoperative anesthetic that is routinely carried out at the Department of Day Surgery, the difference in timing of the patient's discharge from the hospital (ie when the patient has autonomous demabulation and urination spontaneous) in patients undergoing correction of varicocele according Marmar.


Eligibility Criteria:
Inclusion Criteria:

* Male
* ASA I-II
* No mental alteration

Exclusion Criteria:

* Chronic pain
* Allergies to local anaesthetics, acetaminophen,oppioids
* ASA III - IV
* Postoperative discharge to ICU
* Epatic or renal failure
* Mental status alteration
* Coagulopathy
Effect of Low Calorie Diet With Rice Bran Oil on Cardiovascular Risk Factors in Hyperlipidemic Patients

The purpose of this study is to determine the effect of rice bran oil with low calorie diet on lipid profiles.

This study is parallel groups' randomized clinical trial with a pre and post test design.

The study conducted on hyperglycemia patients who were healthy in other respects and were recruited from nutrition and diet therapy clinic. All subjects received a low calorie diet for 4 weeks from registered dietitian.

Treatment group received the low- calorie diet including (30g/day) rice bran oil.

Eligibility Criteria:
Inclusion Criteria:

* hyperlipidemia

Exclusion Criteria:

* pregnancy and lactation
* cardiovascular disease
* diabetes
Systemic Inflammation During Recanalization of Cerebral Arterial Occlusion

Strokes management, secondary to proximal arterial occlusion, by endovascular thrombectomy (TM) is now well established. The immuno-inflammatory events of reperfusion after TM are discussed. Systemic inflammation is a major factor suggested to explain the limited recovery of the ischemic parenchyma. Understanding these phenomena is necessary before developing an immunomodulatory strategy.


Eligibility Criteria:
GROUP "AVC" :

Inclusion Criteria:

* Adults patient (s)
* Ischemic stroke by occlusion of a middle cerebral artery (proximal portion M1)
* Initial diagnostic MRI infusion
* TM with complete reperfusion (TICI 2b, 2c or 3)
* TM performed under local anesthesia +/- anxiolysis, or sedation including propofol
* mRS prior to stroke \<2
* Barthel index \<90
* Included in the HIBISCUS cohort
* Patient who was informed and did not object to participating in the study OR included through the emergency procedure then collection of his non-objection or that of his trusted person as soon as possible

Exclusion Criteria:

* NIHSS awareness score\> or = 2
* Haemorrhagic complication before thrombectomy
* Pregnant woman
* Multiple vascular occlusions
* Occlusions of posterior or anterior cerebral territories other than M1
* Protected major
* TM performed under general anesthesia
* Other vital failure than neurological failure

GROUP "CONTROL" :

Inclusion Criteria:

* Adults patient (s)
* mRS \<2
* Barthel index \<90
* Requiring diagnostic arteriography for routine check-up of a cerebrovascular malformation
* Patient who was informed and did not object to participating in the study

Exclusion Criteria:

* NIHSS awareness score\> or = 2
* Pregnant woman
* Protected major
* Exam performed under general anesthesia
Efficacy of Platelet-rich Plasma Injection Compare With Corticosteroid in Pes Anserinus Pain Syndrome

The goal of this research is to study the efficacy of treatment between PRP injection and corticosteroid injection in patients with pes anserinus bursitis. The research question is whether PRP can reduce pain more effectively than corticosteroids.

The study is divided into two groups: one group receiving PRP injections and the second group receiving corticosteroid injections. Treatment outcomes will be monitored at four time points: baseline, 4 weeks, 12 weeks, and 24 weeks. The outcomes will be measured using the VAS and WOMAC scores.

Randomization of patient with pes anserinus bursitis at opd od ramathibodi hospital.

Objective : to study the efficacy of treatment between PRP injection and corticosteroid injection in patients with pes anserinus bursitis

Medhods :

A randomized controlled trial , Single blinded Participants : Patients with pes anserinus bursitis Randomization : Randomization will be performed using the software STATA 16.0 (StataCorp, College Station, Texas, USA). A various blocked randomization method

Interventions and control :

* Experimental groups : PRP injection 4 ml
* Control groups : Steroid injection , Triamcinolone acetonide(40mg/ml) 1 ml + 1%Lidocaine without adrenaline 3 ml = 4ml By Orthopedic surgeon with ultrasound guide.

Allocation and concealment :

A central randomization service will prepare sealed envelopes containing the assigned treatment for each patient.

The envelopes will be kept in secure location until Break the concealment at outpatient orthopedics department , Ramathibodi hospital

Blinding :

Randomized controlled trial study, Single blinded The assessor who will be follow up the patients, will be blinded to the group assignments.

Outcome measures:

Visual Analogue Scale (VAS) , Womac scores

Follow up:

at 4 weeks, 12 weeks, and 24 weeks after injection.

Statistic analysis:

STATA 16.0, StataCorp, College Station, Texas, USA Analysis Demographic data : mean, SD Mean difference in patient-relevant outcomes : Independent T- test

Eligibility Criteria:
Inclusion Criteria

* Over 18 years old
* Patients diagnosed with Pes Anserine Pain Syndrome
* Patients willing to participate in the research project by signing a consent form

Exclusion Criteria:

* Patients with a localized knee infection or a disseminated infection within the past 3 months
* Patients with thyroid disorders, rheumatoid arthritis, or other types of knee arthritis
* Patients with abnormal blood coagulation or thrombocytopenia
* Patients who are pregnant
* Patients with any type of cancer
* Patients who cannot follow up with treatment until the end of the project
* Patients who are unwilling to participate in the project or wish to withdraw from the research project
Comparison of Ultrasound-guided Electrolysis Therapy vs. Sham Electrolysis in Patients With Patellar Tendinopathy: A Prospective Randomized Study Including MRI and Shear-wave Ultrasound Elastography Imaging

Study Background and Purpose Tendinopathies are common and debilitating musculoskeletal disorders that often lead to chronic pain and reduced mobility. Traditional treatments face challenges due to limited tendon blood supply, leading to poor healing. This study investigates ultrasound-guided galvanic electrolysis therapy (USGET), which uses electric current to promote tendon healing, comparing its efficacy with a placebo.

Objectives The primary goal is to assess pain reduction, while secondary goals evaluate functionality, elasticity, and morphological changes (imaging) in patients with patellar tendinopathy.

Methodology

* Design: Prospective, randomized, double-blind, placebo-controlled study.
* Duration: 24 months (October 2024 - October 2026).
* Groups:
* Intervention Group: Electrolysis therapy with galvanic current, Progressive tendon-loading exercises.
* Control Group: Electrolysis placebo (without current), Progressive tendon-loading exercises.
* Sample Size: 74 subjects.
* Data Collection: Baseline, post-treatment (4 months), and follow-up (7 months).

Evaluation and Data Analysis The study assesses pain via VAS and functionality scores, alongside imaging (MRI, sonography) to measure tendon morphology. Statistical analysis includes hypothesis testing and regression using SPSS software.

Ethics and Publication Ethics approval is from the Bremen Medical Chamber. Results will be published regardless of outcome, following Good Clinical Practice and the Declaration of Helsinki.


Eligibility Criteria:
Inclusion Criteria:

* Age: 18 - 59 years,
* Informed consent (capable of giving consent),
* Presentation and diagnosis of patella tendinopathy without other concomitant musculoskeletal diseases or degenerative joint disease.

Exclusion Criteria:

* Children (\< 18 years), age \> 59 years,
* Pregnancy and breastfeeding,
* Patients who are unable to give consent,
* Musculoskeletal concomitant diseases such as fractures, sprains, dislocations, structural muscle injuries, meniscopathies, cruciate ligament injuries,
* Joint diseases (acute, degenerative) such as arthrosis or arthritis,
* Acute infections / open wounds in the area of the tendon to be examined
* Other relevant damage to the tendon to be examined
* Local steroid injections into the tendon before and after the start of the study,
* Injections of vascular sclerosing agents before and after the start of the study,
* Ingestion of fluoroquinolones, anticoagulants or anti-inflammatory drugs.
HEMS for Mechanical Thrombectomy

Elapsed time from the onset of stroke symptoms to the point of revascularization is the key determinant of the optimal outcome of acute ischemic stroke. Pharmacological treatment is less effective if the thrombus occluding the artery is big enough and mechanical thrombectomy is required to gain recanalization. Mechanical thrombectomy can be done only in comprehensive stroke centres. There are 5 comprehensive stroke centres in Finland which causes regional inequality when it comes to reaching mechanical thrombectomy in a reasonable time limit.

The aims of the study is to measure the effect of dispatching a helicopter emergency medical services unit on the treatment delays of a stroke patient with large vessel occlusion. The HEMS unit is dispatched to both: getting patient directly to the comprehensive stroke centre as well as to interfacility tranfers.


Eligibility Criteria:
Inclusion Criteria:

- all adult patients transferred for mechanical thrombectomy from the South Ostrobothnia Hospital District to the Tampere University Hospital

Exclusion Criteria:

* The neurologist on call at the Tampere University hospital deems the patient unable to benefit from mechanical thrombectomy
Bipolar Plasmakinetic TURP Vs Monopolar TURP in the Treatment of Lower Urinary Tract Symptoms

Randomized controlled trial with one-year follow-up comparing intra, peri and postoperative outcomes for plasmakinetic transurethral resection of prostate (PK-TURP) and monopolar transurethral resection of prostate (M-TURP) in the treatment of LUTS due to BPH in a tertiary-care public institution

The study is a randomized controlled trial with one-year follow-up comparing intra, peri and postoperative outcomes (efficacy, complications and sequelae) for plasmakinetic transurethral resection of prostate (PK-TURP) and monopolar transurethral resection of prostate (M-TURP) in the treatment of LUTS due to BPH in a tertiary-care public institution (Madrid, Spain)

Eligibility Criteria:
Inclusion Criteria:

* Sign the informed consent voluntarily and will be willing to follow-up
* Prostate volume \<80 g
* Meet any conditions (1) Diagnose of LUTS due to refractory to drugs BPH. (2) presenting complications derived from BPH (bladder calculi, recurrent haematuria, recurrent urinary tract infections, acute urinary retention)
* The use of antiplatelet agents or anticoagulant drugs is allowed.

Exclusion Criteria:

* Previous history of pelvic surgery
* Previous history of pelvic radiotherapy
* Previous history of neurogenic bladder dysfunction
* Documented or suspected prostate carcinoma
* Patients with severe cardiopulmonary disease or severe mental disorders
* Poor compliance, and can not be followed up.
Restoration of Disc Height Reduces Chronic Low Back Pain

The investigators hypothesize that a 6-week treatment of non-invasive spinal decompression reduces discogenic low back pain (LBP), increases lumbar disk height, and that an increase in lumbar disc height is associated with decreased LBP.


Eligibility Criteria:
Inclusion Criteria:

* at least 18 years of age;
* consented for the 6 weeks treatment protocol;
* presented with discogenic low back pain of at least 3 out of 10; AND
* current CT scan not older than 2 months.

Exclusion Criteria:

* metastatic cancer;
* previous spinal fusion or placement of stabilization hardware;
* instrumentation or artificial discs;
* neurologic motor deficits, bladder, or sexual dysfunction;
* alcohol or drug abuse; OR
* litigation for a health-related claim (in process or pending for workers' compensation or personal injury).

Limitations of the spinal decompression system also led to the exclusion of patients with extremes of height (\< 147 cm or \> 203 cm) and body weight (\> 136 kg).