cyrilzakka/clinical-trials huggingface dataset:
Mastering Hospital Antimicrobial Resistance and Its Spread Into the Community

Data on occurrence of antimicrobial resistant bacteria acquisition in rehabilitation centers will be collected. After removal of patient identifiers, information regarding the patients population will be entered into electronic sheet. The phase will last twelve months in each center.

All patients admitted to the department will be examined on admission, two weeks latter and monthly by obtaining nares and perirectal cultures. These cultures will be processed for detection the target organisms. This activity is part of the good medical practice and is performed on routine basis in various hospital units

Epidemiological data will be collected from patient records. This data will be stored after removal of all patients' identifiers. These data will be transferred for analysis to Tel Aviv Medical Center

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized patients are older then 18 years old

Exclusion Criteria:

* Age 18 years or less
ICBT for Mental Health Problems Related to the Climate Crisis

The study seeks to investigate the effects of a guided internet-based cognitive behavioral therapy (ICBT) programme on adult mental health problems related to the climate crisis. ICBT will be compared to a wait-list control group.

Participants will be recruited in Sweden with a nationwide recruitment.

The study is set up as a randomized controlled trial. Quality of life, depressive symptoms, anxiety, sleep problems and traumatic stress will be measured. Given uncertainties regarding the psychological effects connected to the climate crisis, a transproblematic tailored treatment approach will be used that has been tested in several previous trials. However, the present program has been adapted for the target population of people who are affected directly or indirectly by the societal and individual consequences of the climate crisis.

Eligibility Criteria:
Inclusion Criteria:

Experience mental health problems that are caused or exacerbated by the climate crisis and/or its consequences 18 years or older. Adequate ability to understand and speak Swedish. Access to the internet and a smartphone/computer.

Exclusion Criteria:

Other ongoing psychological treatment or counselling that interfere with trial treatment.

Recent (within the past 3 months) changes in the dose of psychotropic medication.

Any severe psychiatric or somatic conditions that would interfere with trial treatment
Comparing Laparoscopic and Open Pancreaticoduodenectomy for Nonpancreatic Periampullary Adenocarcinomas

The aim of this study was to evaluate the outcomes of LPD versus OPD in non-pancreatic periampullary adenocarcinoma

The aim of this study was to evaluate the outcomes of LPD versus OPD in non-pancreatic periampullary adenocarcinoma

Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 years and 75 years.
2. Histologically confirmed NPPC or clinically diagnosed NPPC by an MDT without histopathologic evidence.
3. Patients feasible to undergo both LPD and OPD ac- cording to MDT evaluations.
4. Patients understanding and willing to comply with this trial.
5. Provision of written informed consent before patient registration.
6. Patients meeting the curative treatment intent in ac- cordance with clinical guidelines.

Exclusion Criteria:

1. Patients with distant metastases, including peritone- al, liver, distant lymph node metastases and involve- ment of other organs.
2. Patients requiring left, central or total pancreatecto- my or other palliative surgery.
3. Preoperative American Society of Anaesthesiologists (ASA) score ≥4.
4. History of other malignant disease
5. Pregnant or breastfeeding women.
6. Patients with serious mental disorders
7. Patients treated with neoadjuvant therapy.
8. Patients with vascular invasion and requiring vascular resection as evaluated by the MDT team according to abdominal imaging data.
9. Body mass index \>35 kg/m 2 .
10. Patients participating in any other clinical trials with- in 3 months.
Evaluation of the Implementation of the Pharmacogenetics and Personalized Medicine Program "MedeA" in the Extremadura Health Service.

An open longitudinal observational study, non-randomized, which will include the adult population, attended by the SES, in which preference will be given to those patients under treatment with drugs that can produce relevant adverse effects. It is a naturalistic study in which no pharmacological or other type of intervention will be carried out, only the information recommended in the drug data sheet (pharmacogenetic biomarkers, relevant interactions and clinical contraindications) will be provided.


Eligibility Criteria:
Inclusion Criteria:

Patients with a recent diagnosis and who are to be or are being treated according to usual clinical practice, who meet the criteria to participate in the study, read the corresponding information sheet, sign informed consent and agree to participate, provided they meet the following inclusion criteria:

General criteria for all patients:

* Age ≥ 18 years. In case of minors, they may be included, under the following assumptions:
* If the minor is under 12 years of age, participation will require the consent and signature of the informed consent document by both parents (or their guardian).
* If the minor is between 12 and 16 years of age, a proxy informed consent form will be provided and signed by both parents (if both parents are present at the time of the interview) or only one of them (in which case one of the following two conditions must be stated: that the other parent is not present at the time of the interview but does not object to the participation of the minor in the study or that the signatory is the sole legal guardian of the minor).
* Be registered or potentially/have been attended in the Extremadura Health Service.
* Not have language or communication barrier or present disability being totally dependent on another person.

Exclusion Criteria:

* Failure to meet any of the inclusion criteria described above.
* Refusal by the patient to be part of the cohort initially, or to continue to be part of the cohort during follow-up.
* Manifest difficulty for follow-up.
GAT-DCT-Discordance Due to Corneal Properties

IOP is measured with two devices (Dynamic Contour Tonometry (DCT) and Goldmann applanation tonometry (GAT)).

DCT reading will be compared to a corrected GAT reading by the formula of Elsheikh, Alhasso and Pye.

* Trial with medical device

Eligibility Criteria:
Inclusion criteria:

* clinical diagnosis of glaucoma

Exclusion criteria:

* other optic neuropathy other then glaucoma
* age\<18
* corneal surgery
* use of contact lenses
Long Term Follow up Mesenchymal Stem Cell Therapy for Patients Virus-related Liver Cirrhosis

This is a study to assess safety and preliminary clinical activity of treatments of liver cirrhosis in patients with caused by Hepatitis C and Hepatitis B or Nonalcoholic Steatohepatitis of Mesenchymal stem cell.

Patients who will be enrolled in the study will be under supervision and monitoring to ensure clinical significance

Liver cirrhosis refers to extreme scarring of the liver, resulting in suboptimal function of the liver. It can result from a variety of causes, ranging from hepatitis B and C infection, excessive alcohol consumption, autoimmune causes, fatty liver and others. Irrespective of the cause, once the liver becomes cirrhotic, it is a downhill course.

Liver cirrhosis is irreversible and most patients will progressively worsen over time. Once liver cirrhosis has reached the stage of decompensation, that is, development of jaundice, ascites, variceal bleeding, hepatic encephalopathy and coagulopathy the two-year survival drops to about 50%.

The definitive treatment of decompensated cirrhosis is liver transplantation. While a liver transplantation is potentially curative, the high costs, lack of a donor, treatment-related mortality and the immunosuppression complications make this option possible only for a limited number of patients. The vast majority do not have an effective option at all, thus the need to develop alternative therapies. Various types of Stem Cells had been investigated as a regenerative therapy for liver cirrhosis. These stem cells include bone marrow mesenchymal stem cells (MSC). Some early studies have shown encouraging results in patients who had autologous bone marrow stem cell transplantation. There was improved liver function in these patients with cirrhotic livers.

The sponsor is proposing a study to look into the role of MSC therapy for patients with liver cirrhosis in Ukraine. This will be a Phase I study with the main emphasis on the safety and efficiency profile first. The trial will be conducted in compliance with the protocol, GCP and local regulatory requirement(s).

Eligibility Criteria:
Inclusion Criteria:

Provision of written informed consent for this study by subject or as applicable legal guardians Able to comply with study requirements Еру rates with RVR defined as serum HCV RNA undetectable after 12 month after antiviral therapy.

Subject must have documented compensated cirrhosis and no current or past clinical evidence of decompensated liver disease Subject must have documented history Screening laboratory result indicating hepatitis C virus (HCV) Genotype 1, 2, 4, 5 or 6 (GT1,2,4,5,6) infection

Exclusion Criteria:

Positive test result at screening for Hepatitis B surface antigen or anti-human immunodeficiency virus (anti-HIV) antibody HCV genotype performed during screening indicating co-infection with more than 1 HCV genotype.
MT2022-01: MSCs for ALD

This is a single-institution study to evaluate the use of intravenously administered allogeneic, 3rd party mesenchymal stem cells (IV-MSC) in patients with active, cerebral adrenoleukodystrophy (CALD), as a bridge to hematopoietic stem cell transplant or gene therapy, or in patients who are too advanced for gene therapy or HSCT. The intervention will occur in the time between diagnosis of active CALD and transplant which is currently 8-12 weeks.


Eligibility Criteria:
Inclusion Criteria:

* age ≥ 3 years
* diagnosis of ALD, as established by elevation of very long chain fatty acid levels or gene mutation
* evidence of active cerebral disease as determined by the presence of gadolinium enhancement
* ALD MRI (Loes) score ≥ 1
* Patients who have not received prior gene therapy or transplant
* Life expectancy of \> 6 months as determined by the enrolling researcher
* Have adequate organ function confirmed by laboratory values obtained within 28 days prior to enrollment

Exclusion Criteria:

* Inability to undergo sedation or MRI studies for any reason
* Other concurrent life-threatening disease (life expectancy \<6 months) or eligible for hospice care
* Known or suspected hypersensitivity to human serum albumin, diphenhydramine, acetaminophen, methylprednisolone, or any of the components of IMS001.
Retinal Thickness and Volume Estimates Given by Time Domain and Spectral Optical Coherence Tomography

The purpose of the present study is to determine if the retinal thickness estimates of the Stratus OCT, the 3D OCT-1000, and the CirrusHD OCT are comparable in diabetic and in healthy individuals (OCT=Optical Coherence Tomography).


Eligibility Criteria:
Inclusion Criteria:

* diabetic retinopathy in the diabetic group
* healthy retinas in the healthy group

Exclusion Criteria:

* not able to cooperate
* retinal disease other than macular oedema
* severe media opacities (e.g. cataract)
* prior macular laser photocoagulation except for large oedemas
A Full Digital VS Conventional Protocol in Management of Zygomatico-Maxillary Complex Fracture

this study aims To evaluate The Accuracy of Zygomatico- Maxillary Complex (ZMC) Fracture reduction and fixation Using customized Patient-Specific implant and patient-specific predictive holes surgical guide Versus Conventional Technique of reduction and fixation.

The ZMC has multiple points of articulation with the craniofacial skeleton making accurate assessment of reduction at all articulations intraoperative in multiple planes very challenging and the interference of soft tissue edema and a narrowed visual field increases the possibility of intraoperative overcorrection or underestimation of pre-injured position of all fracture lines at the same time resulting in a suboptimal reduction. As a trial to maximize the benefits of digital planning carrying the plan into a real operating room using a patient-specific surgical guide to predrill screw holes and guide patient-specific implants during fixation according to the planning depend on CT scan.

Eligibility Criteria:
Inclusion Criteria:

* Zygomatic Fracture Types III, IV, V, VII, and VIII according to Rowe and Killey's classification.
* Age range (18-60 years).
* Patients are willing for the surgical procedure and follow-up, with informed consent

Exclusion Criteria:

* Zygomatic Fracture Type I, II according to Rowe and Killey's classification.
* Patients with contraindications for general anesthesia.
* Patient on radiotherapy.
* Patients suffer from bone disease.
Lactobacillus Plantarum 299v in Colon Surgery

Intestinal pathogenes are often involved in postoperative complications after colon surgery. Probiotic bacteria, i e live bacteria which have beneficial effects on the host when ingested, have been shown to reduce bacterial translocation in animal studies. However, in humans studies results have varied. The purpose with this study was to find whether high doses of Lactobacillus plantarum 299v affects the potentially pathogenic microflora of the gut, bacterial translocation and cell proliferation in patients undergoing planned colon surgery.


Eligibility Criteria:
Inclusion Criteria:

* planned resection of colon for malignant or benign disease
* all ages

Exclusion Criteria:

* unable to understand instructions and perform preoperative intake of study preparation
* rectal surgery
* present or past history of endocarditis
* congenital or acquired valvular heart disease
Prevalence and Prognosis of Cardiac Amiloidosis in Turkey

Patients with left ventricular hypertrophy are further examined according to an algorithm to check if they have a cardiac amyloidosis


Eligibility Criteria:
Inclusion Criteria:

* Patients with left ventricular hypertrophy without left ventricular pressure or volume (IVS≥13mm)
* Patients with left ventricular hypertrophy and hypertension or aortic stenosis without left ventricular pressure or volume (IVS\>15mm)

Exclusion Criteria:

* Patients with left ventricular pressure or volume except the ones with aortic stenosis and arterial hypertension
* Patients with sigmoid septum and their hypertrophy limited in sigmoid area
* Patients with highly probable sarcometric hypertrophy cardiomyopathy confirmed with LV morhpology and genetic testing
A Dose Escalation Study in Adult Patients With Advanced Solid Malignancies

The study will determine the maximum tolerated dose and thus the recommended phase II dose and schedule of the compound and characterize the safety.


Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically/cytologically confirmed advanced solid tumors with FGFR1 or FGFR2 amplification or FGFR3 mutation, for which no further effective standard anticancer treatment exists
* Adequate bone marrow function
* Adequate hepatic and renal function
* Adequate cardiovascular function
* Contraception.

  * For women: Must be surgically sterile, post-menopausal, or compliant with a medically approved contraceptive regimen during and for 3 months after the treatment period; must have a negative serum or urine pregnancy test and must not be nursing.
  * For men: Must be surgically sterile or compliant with a contraceptive regimen during and for 3 months after the treatment period

Exclusion Criteria:

* Patients with primary CNS tumor or CNS tumor involvement
* Patients with history and/or current evidence of endocrine alteration of calcium-phosphate homeostasis
* History and/or current evidence of ectopic mineralization/ calcification including but not limited to the soft tissue, kidneys, intestine, myocard and lung with the exception of calcified lymphnodes and asymptomatic coronary calcification
* Current evidence of corneal disorder/ keratopathy incl. but not limited to bullous/ band keratopathy, corneal abrasion, inflammation/ulceration, keratoconjunctivitis etc., confirmed by ophthalmologic examination.
* History or current evidence of cardiac arrhythmia and/or conduction abnormality
* Women who are pregnant or nursing.

Other protocol-defined inclusion/exclusion criteria may apply
Comparing The Outcome of Large-Diameter vs Small-Diameter Glenospheres in Primary Reverse Shoulder Arthroplasty

The study will compare the outcome of primary reverse shoulder arthroplasty using the Stryker ReUnion System with implantation of either a large (40 mm) or a small (36 mm) glenosphere with either a +2 mm or a +6 mm offset.


Eligibility Criteria:
Inclusion Criteria:

* Subjects willing to sign the informed consent
* Male and non-pregnant female subjects ages 50 - 90 at the time of surgery
* Subjects requiring a primary reverse total shoulder arthroplasty
* Subjects with the diagnosis of cuff-tear arthropathy (CTA), massive irreparable rotator cuff tear (MRCT) or osteoarthritis (OA) with marked posterior subluxation or bone loss

Exclusion Criteria:

* Inability to comply with follow-up requirements
* Subjects with inflammatory arthritis
* Subjects with proximal humerus fractures
* Subjects with sequels of trauma
* Subjects that are immunologically compromised
* Subjects with an active or suspected latent infection in or about the shoulder
* Need to add a tendon transfer
* Need for structural humeral bone graft
* Pregnant subjects
Intralesional Cemiplimab for Adult Patients With Cutaneous Squamous Cell Carcinoma or Basal Cell Carcinoma

This study is researching an experimental drug called cemiplimab. The study is focused on Cutaneous Squamous Cell Carcinoma (CSCC) and Basal Cell Carcinoma (BCC).

The aim of the study is to evaluate the safety and tolerability (how your body reacts to the drug) of cemiplimab (also known as REGN2810).

The first part of the study tested several different doses of cemiplimab given weekly for 12 weeks.

The study is also looking at several other research questions, including:

* What side effects may happen from taking the study drug
* To see effect of cemiplimab on the tumor
* How much study drug is in the blood at different times


Eligibility Criteria:
Key Inclusion Criteria

1. Dose Escalation: History of recurrent resectable CSCC or BCC (Cohort C and I only) that satisfies conditions as defined in the protocol
2. Patients must have measurable disease in the index lesion, defined as 1-2 cm in the longest diameter
3. Eastern Cooperative Oncology Group (ECOG) performance status ≤1

Key Exclusion Criteria

1. Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune-mediated adverse events (imAEs)
2. Prior treatment with an agent that blocks the programmed cell death 1 (PD-1)/ programmed cell death 1 ligand (PD-L1) pathway.
3. Prior treatment with other systemic immune modulating agent as defined in the protocol
4. M1 or N1, N2 (a, b, or c), or N3 CSCC or BCC. Patients with history of metastatic CSCC (distant or nodal), or metastatic BCC (distant or nodal) are excluded unless the disease-free interval is at least 3 years
5. Concurrent malignancies, other than those with negligible risk of metastasis or death. Patients with hematologic malignancies, including chronic lymphocytic leukemia (CLL), are excluded.
6. Patients with a history of solid organ transplant
7. Has received a Coronavirus induced disease of 2019 (COVID-19) vaccination (initial series and booster) within 1 week of planned start of study medication

Note: Other protocol defined Inclusion/Exclusion criteria apply.
Gait Profile Score in Children With Cerebral Palsy (CP): Influence of the CP Type, Treatment With Botulinum Injection and Multilevel Surgery

Instrumented three dimensional gait analysis (3DGA) permits to record spatial, temporal, kinetics, kinematics and electromyographic (EMG) parameters in order to understand gait impairment in children and teenagers with cerebral palsy (CP). Nowadays, single-event multilevel surgery in subjects with CP cannot be performed without 3DGA. However, interpretation of multiple and interdependent data remains complex for the clinician. To address this issue, gait statistical index have been developed to give a single measure of the quality of the gait pattern. Among actual index, the Gait Profile Score (GPS), developed by Baker et al (2009), measure the deviation of kinematics parameters from a controlled dataset. The GPS can be divided in nine Gait Variable Score (GVS), corresponding to major lower limb joints: the MAP (Movement Analysis Profile). Many studies have reported the interest of the GPS to analysis gait of subjects with CP: good inter-session reliability, predictor of postoperative kinematic improvement, minimal clinical threshold calculated at 1.6°, significant relationship with clinical data (joint contractures), and sensibility to change after a single-event multilevel surgery.


Eligibility Criteria:
Inclusion Criteria:

* Etiology of cerebral palsy
* Unilateral, bilateral, triplegic or quadriplegic forms of cerebral palsy.
* 6 to 18 years old
* GMFCS (Gross Motor Function Classification System) I to III
* Instrumented gait analysis of the laboratory of St-Etienne
* Absence of botulinum toxin injection or serial casting in the three months after a first instrumented gait analysis.

Exclusion Criteria:

* Etiology others than cerebral palsy as defined classically (ex: ischemic infarcts in a child older than two years).
* Previous surgery in lower-limb.