cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Interest Chemo-oncogramme in Patients With Colonic Adenocarcinoma Stage 4

In patients with colonic adenocarcinoma stage 4 which are potentially resectable metastases (lung and liver metastases), treatment with chemotherapy is necessary but not end in success in 10% of cases. The development of techniques for administering personalized treatment becomes necessary for these patients. Thus, in vitro tests on cells from tumors of these patients and evaluating the effect of chemotherapy on these could be made for each patient. In France, the company develops Oncomedics these tests.

This is a pilot study that will make a first evaluation under actual conditions of chimio-oncogramme.

A fragment of colon tumors will be taken from a specimen or a cold biopsy, tissue from patients diagnosed with colon carcinoma metastatic (stage 4). In parallel and systematically: analysis by the pathologist of a histological section.

* Culturing the cells obtained from the tumor by Oncomedics fragment in a defined medium and provided for enriching tumor cells compared to stromal cells.
* Maintaining the cells in culture for 7 days.
* Effects of conventional chemotherapy (corresponding to protocols) on these cells for 72 hours (growth chambers) by Oncomedics (chimio-oncogramme).
* For each chemotherapy tested, measuring the proportion of dead cells / total cells.
* Retained by Oncomedics results, not given to the nursing team. The patient will be treated and followed up in the usual way.
* At the end of the study, comparing the in vitro results (chimio-oncogramme) to the patient's response to (x) the same (s) chemotherapy (s).

Eligibility Criteria:
Inclusion Criteria:

* patient with adenocarcinoma of the colon diagnosed at stage 4 receiving standard therapy
* targets must be measurable tumor lesions (RECIST)
* patient has not expressed opposition to the use of their residual tumor

Exclusion Criteria:

* Against-formal indication to an indispensable para-clinical examination of the patient monitoring
* Use of chemotherapy, hormone therapy or concomitant radiotherapy
* Cons-indication for chemotherapy
* Are pregnant, nursing or lack of contraception for women of childbearing age.
Corneal Endothelium After Phacoemulsification in Pseudo Exfoliation Syndrome

To study corneal endothelial cells changes after phacoemulsification in patients with senile cataract and pseudoexfoliation syndrome (PEX) compared with control patients with senile cataract using specular microscope.

In a prospective interventional case-control study, 20 eyes with cataract and PEX and 20 control eyes with cataract without PXE were subjected to phacoemulsification and posterior chamber foldable intraocular lens implantation in Minia University Hospital and Genaidy Eye Center between March 2019 and December 2020. Specular microscopy was done preoperatively, 3 and 6 months postoperatively. Endothelium cell density (ECD), coefficient variation (CV), hexagonality, pleomorphism and corneal thickness were evaluated and compares between PXE and control eyes.

Eligibility Criteria:
Inclusion Criteria:

* senile cataract age more than 55 years

Exclusion Criteria:

* PEX with glaucoma, eyes with cornea guttata or any corneal dystrophy, zonular dehiscence, very dense nuclear cataract (cataracta nigra) history of previous ocular surgery.
Outcome of Accessory Rods and Ilic Fixation for Distal Augmentation of S1 Fixation

To assess radiological and clinical outcome of use of accessory rod and iliac fixation for distal augmentation of L1 fixation

Lumbar fusion is a surgical procedure that can be utilized to treat a variety of painful and degenerative conditions in the lower back. The most common conditions that indicate the need for an L5 S1 fusion include low back disc degeneration (also known as spondylolisthesis), spinal fractures, recurrent disc herniation, scoliosis, lumbar canal stenosis, and instability resulting from failed spine surgery . The success rate of lumbo sacral fusion surgery is influenced by many factors. These include non-union, hardware breakage or loosening, discitis, osteoporosis, tumors, and pseudoarthrosis . Lumbosacral pseudarthrosis is one of the most common complications in L5 S1 fusion surgery. It is a strong indication for revision surgery if severe symptoms persist. The rate of pseudarthrosis increases based on several parameters, including the number of levels fused, the type of fusion, and medical risk factors for pseudarthrosis .

There are various methods of revision. One such method involves the use of iliac screws in addition to lumbo sacral interbody fusion. This approach improves the outcomes of revision fusion surgery but still carries the risk of rod breakage . S2 alar-iliac (S2AI) screws have been described as another method, but they have some disadvantages like rod breakage, screw misplacement, breach of cortical bone, and injury to neurovascular structures. These structures include superior gluteal vessels, external iliac vessels, pudendal vessels, superior gluteal nerves, sciatic nerve, and sympathetic chain ganglia . Our theory proposes the use of an accessory rod, which offers the advantage of dual rod fixation with a low incidence of rod breakage. We also suggest the free-handed placement of the iliac screw in the iliac bone, which plays a significant role in improving the integrity of the fixation and simplifies the application process.

Multiple-rod constructs could prevent rod breakage and pseudarthrosis while also lowering the revision rate. As a result, they could lead to a better clinical outcome than the 2-rod construct. This approach is based on the principle that increasing the number of rods in the construct can distribute the load more evenly, reducing the risk of rod breakage and pseudarthrosis. This, in turn, could lead to a lower revision rate and better clinical outcomes

Eligibility Criteria:
Inclusion Criteria:

* The study will include all patients who were admitted to the spine unit and needed extension of fixation for L5 S1 fusion due to failed previous surgery, instability, or degenerative changes ,infection, tumors and pseudoarthrosis.

Exclusion Criteria:

* The study excludes patients who are less than 18 years and more than 90 years
Effects of Training on Fall Risk and Balance Performances

Dual task training has been shown to reduce the risk of falls more than single task training. However, there have been no studies which compared the effects of single task training, dual task training and asynchronous cognitive, balance exercise training during same day on the risk of falls among healthy older individuals. Therefore, the aim of this study was to investigate differences among the effects of single task training, dual task training and exercise-cognitive activity combined training on balance and gait performances and fall risk in elderly at risk of fall.

The term "dual task" refers to the ability of performing 2 tasks simultaneously, for example, a cognitive and a motor task. Previous studies demonstrated that dual task training is more effective than single task training in reducing falls among elderly. These studies demonstrated that the improvements in balance and gait speed resulted in a decrease of fall frequency. Although dual task training has been shown to reduce the risk of falls more than single task training, to date, there have been no studies which compared the effects of single task training, dual task training and asynchronous cognitive, balance exercise training during same day on the risk of falls among healthy older individuals. Therefore, the aim of this study was to investigate differences among the effects of single task training, dual task training and exercise-cognitive activity combined training on balance and gait performances and fall risk in elderly at risk of fall.

Eligibility Criteria:
Inclusion Criteria:

* Age 65 years or older
* literate
* having a fall incident during the past year
* ability to walk 10 meter without any support
* getting more than 13.5 seconds at Timed up and Go test
* getting less than 24 points at Standardized Mini-Mental State Examination

Exclusion Criteria:

* neurological or musculoskeletal diagnosis such as Parkinson's or Alzheimer's disease,
* orthopaedic involvement or significant visual and auditory impairments
A Study of Single-Agent Eribulin Mesylate as First-Line Therapy for Locally Recurrent or Metastatic Human Epidermal Growth Factor Receptor Two (HER2) Negative Breast Cancer

The purpose of this study is to assess the efficacy and safety of single-agent eribulin mesylate for first-line treatment of subjects with locally recurrent or metastatic breast cancer.

This is a multicenter, single-arm, Phase 2 trial to assess the efficacy and safety of single-agent eribulin mesylate for first-line treatment of subjects with locally recurrent or metastatic human epidermal growth factor receptor (HER2)-negative breast cancer. A total of 52 adult female subjects will be enrolled and treated with eribulin mesylate (1.4 mg/m2 as an intravenous \[i.v.\] infusion over 2 to 5 minutes on Days 1 and 8 of each 3-week cycle).

Eligibility Criteria:
Key Inclusion Criteria

Females age 18 years or older at the time of informed consent

Have histologically or cytologically proven adenocarcinoma of the breast

Subjects with locally recurrent or metastatic disease with at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors

(RECIST) criteria v 1.1

Human epidermal growth factor receptor (HER2)-negative disease as determined by fluorescence in situ hybridization (FISH) or 0 or 1+ by immunohistochemical (IHC) staining.

Life expectancy of greater than 24 weeks

Eastern Cooperative Oncology Group (ECOG) Performance Score (PS) of 0, 1 or 2

At least 12 months since prior neoadjuvant or adjuvant chemotherapy

At least 2 weeks since prior radiotherapy or endocrine therapy, with complete recovery from the effects of these interventions

Adequate renal function

Adequate bone marrow function

Adequate liver function

Key Exclusion Criteria

Subjects who meet any of the following criteria will be excluded from participation in this study:

Prior chemotherapy, biologic therapy, or investigational therapy for locally recurrent or metastatic breast cancer

Subjects who have had a prior malignancy other than carcinoma in situ of the cervix or nonmelanoma skin cancer

Prior exposure of greater than 360 mg/m2 doxorubicin or liposomal doxorubicin, greater than 120 mg/m2 mitoxantrone, greater than 90 mg/m2 idarubicin, or greater than720 mg/m2 epirubicin

Inflammatory breast cancer

Clinically significant cardiovascular impairment

Subjects with known CNS disease are not eligible, except for those with treated brain metastasis.

Pulmonary lymphangitic involvement that results in pulmonary dysfunction requiring the use of oxygen

Currently pregnant or breast-feeding.

Subjects with pre-existing Grade 3 or 4 neuropathy. Any peripheral neuropathy must recover to Grade 2 before enrollment.
Pectoralis Nerve Block and Quality of Recovery in Mastectomy Patients

Effects of pectoralis nerve block on quality of recovery after breast surgery has been debated. We hypothesized there might exist relevant psychosocial factor or variable of pain sensitivity which would influence on the benefit of nerve block.

This study aims to assess effect of pectoralis nerve block on QoR-15 score in subgroups stratified by such factors.

Study population All of patients will undergo partial mastectomy. 140 patients will be enrolled.

Intervention Pectoralis nerve block will be performed in the Block group.

Psychosocial factor screening Pain-detect, HADS, EQ-5D, PHQ-15 (somatic symptom), PCS (pain catastrophizing), BFI (big five inventory), HAM-A\&D, Pressure algometry (Pain sensitivity), Quantitative sensory test (pinprick)

Study endpoints Quality of recovery (QoR)-15 Pain visual analogue scale Opioid consumption Breast Cancer Pain Questionnaire (BCPQ)

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 20 to 80 years who underwent partial mastectomy for breast cancer.

Exclusion Criteria:

* Patients with a history of previous breast surgery
* Patients with a history of adverse reactions to local anesthetics
* Patients with a history of drug addiction
* Patients with cancer other than breast
* Patients with chronic pain who require analgesics
* History of hospitalization for psychiatric disorders
* Preoperative pulse oximetry (SpO2) \< 95 %
* Left ventricular ejection fraction \< 40%
* Moderate or severe hepatic impairment
* Body mass index over 35 kg/m2
* Blood clotting disorders
* Pregnant/lactating women
* Inability to understand consent forms and answer research questionnaires due to cognitive impairment
* Unable to read consent form (eg illiterate, foreigner, etc.)
* do not perform axillary lymph node dissection
Therapeutic Effect and Safety of Combined Hydroxyurea With Recombinant Human Erythropoietin.

The study hypothesis that treatment with Erythropoietin (EPO) combined with Human Erythropoietin (HUO) therapy will result in hematologic improvement in thalassemia intermedia patients.

Second is to determine whether any of the following correlate with improved hematologic response:

A decrease in hemolysis, as assayed by a decrease in LDH, compared to baseline levels,baseline Erythropoietin levels,baseline hemoglobin levels and baseline reticulocyte counts (or % circulating nucleated erythroblasts/100 WBCs).

Goal:

The aim is to assess the possibility of steady increase of hemoglobin levels in thalassemia intermedia patients by at least 1g/dl above baseline levels during therapy using Hydroxyurea and Erythropoietin, growth evaluation,quality of life (QoL) and decline transfusion requirements during study period. Also to report and compare adverse events with other published data regarding.

To determine whether any of the following correlate with improved hematologic response:

A decrease in hemolysis, as assayed by a decrease in LDH, compared to baseline levels,baseline Erythropoietin levels,baseline hemoglobin level and baseline reticulocyte counts (or % circulating nucleated erythroblasts/100 WBCs).

To assess the possibility of steady increase of hemoglobin levels in thalassemia intermedia patients by at least 1g/dl above baseline levels during therapy using Hydroxyurea and Erythropoietin, growth evaluation , quality of life ( QoL ) and decline transfusion requirements during study period. Also to report and compare adverse events with other published data regarding.

THE following criteria are used when including the patient in the study:

Patients with thalassemia intermedia.Diagnosis based on genetic mutations, hemoglobin electrophoresis and characteristic clinical data at presentation. Patients requiring different transfusion requirements and not transfusion dependent.Patients having a baseline hemoglobin of less than or equal to 6-8g/dl.Patients with normal renal and liver function.

Eligibility Criteria:
Inclusion Criteria:

* Patients with thalassemia intermedia. Diagnosis based on genetic mutations, hemoglobin electrophoresis and characteristic clinical data at presentation.
* Require different transfusion requirements and not transfusion dependent.
* Have a baseline hemoglobin of less than or equal to 6-8g/dl.
* Patients with normal renal and liver function.

Exclusion Criteria:

* Evidence of active hepatitis (ALT \> 5 times above ULN).
* Evidence of renal impairment (serum creatinine \> ULN).
* Patients who are dependent on red blood cell transfusions.
Serum Levels of Klotho as a Possible Biomarker of Peripheral Artery Disease

Klotho, a membrane-bound protein co-receptor for fibroblast growth factor 23 (FGF23), is involved in atherosclerotic process and cardiovascular diseases. It regulates blood glucose and cholesterol levels. In addition, the lack of klotho has been associated with endothelial dysfunction, calcification and accumulation of cholesterol in the arteries, leading to coronary heart disease.

The goal of this observational study is to evaluate the potential use of circulating klotho and FGF23 serum levels as biomarkers of major adverse limb events (MALE) and major adverse cardiovascular events (MACE) in patients with peripheral artery disease (PAD) and chronic limb threatening ischemia (CLTI) requiring a procedure of endovascular revascularization.

The main questions it aims to answer are:

* association between klotho and FGF23 serum levels and major adverse limb events (MALE) after lower extremity revascularization.
* association between klotho and FGF23 serum levels and major adverse cardiovascular events (MACE) after lower extremity revascularization.

Patients with PAD and CLTI requiring lower extremity endovascular revascularization will undergo blood sampling for the dosage of circulating klotho and FGF23 before the endovascular procedure.

Incidence of MACE and MALE will be collected in a 12-months follow-up and will be associated with klotho and FGF23 serum levels at baseline.


Eligibility Criteria:
Inclusion Criteria:

* age of at least 40 years
* Ankle/Brachial Index (ABI) of less than 80
* at least one lower limb stenosis greater than 50% documented by Ultrasound Color Doppler (US)
* stage 4 or 5 PAD diagnosis according to the Rutherford classification
* presence of chronic limb threatening ischemia
* indication for LER of the target arterial stenosis

Exclusion Criteria:

* pregnancy
* acute infections at present or in the previous month
* primary hyperparathyroidism
* revascularization of the lower limb in the previous 3 months
* diabetic foot ulcers with signs of active infection or osteomyelitis
* diabetic peripheral neuropathy
* homozygous familial hypercholesterolemia
* absolute contraindication to antiplatelet therapy
* thrombophilia
* active cancer
* active autoimmune disease
* liver disease at functional status B or C according to Child-Pugh
* contraindication to endovascular revascularization
* organ transplantation
A Study to Evaluate the Antiviral Activity and Safety of HH-003 Injection in Subjects With Chronic Hepatitis B and Hepatitis D Co-infection

This is an open-label phase IIa study of HH-003 to evaluate its antiviral activity and safety in subjects with chronic hepatitis B and hepatitis D co-infection. HH-003 is a human monoclonal antibody targeting the pre-S1 domain of the HBV large envelope protein. It blocks engagement of preS1 with sodium taurocholate co-transporting polypeptide (NTCP), the cellular receptor for HBV/HDV.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent form;
* Male or female subjects aged from 18 to 70 years inclusively;
* 18 kg/m2≤BMI≤32 kg/m2, body weight ≥45 kg for men and ≥40 kg for women;
* Positive HBsAg, anti-HDV IgG antibody and HDV RNA at screening;
* Women of childbearing potential or male subjects with female partners of childbearing potential should agree to use an adequate and highly effective contraceptions from screening to the end of study or until 12 weeks after last dose of the study drug (whichever is longer).

Exclusion Criteria:

* Be pregnant or lactating at screening;
* Subjects with decompensated liver cirrhosis;
* Subjects with liver dysfunction (including but not limited to ascites, hepatic encephalopathy and upper gastrointestinal bleeding) within 3 months prior to screening;
* Average daily alcohol consumption \>40g for men and \>20g for women or drug abuse within 6 months prior to screening;
* Subjects with other serious diseases that is inappropriate for study participation per the Investigator's or the Sponsor's discretion (including but not limited to serious cardiac or pulmonary disease, chronic or recurrent urinary disorders, uncontrolled diabetes and autoimmune diseases, epilepsy requiring treatment);
* History of hepatocellular carcinoma (HCC) or hepatocellular carcinoma suggested by liver histopathology or liver imaging;
* Interferon antiviral therapy within 1 year prior to screening.
Acute Haemodynamic Impact of an IV Glucose-injection

Patients with peritoneal dialysis will be administered an IV glucose-injection to evaluate the haemodynamic impact of this injection. The patients will be matched with healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* \> 18 years old
* Stable clinical condition
* Either peritoneal dialysis (at least one month) either matched healthy subject

Exclusion Criteria:

* Heart Failure
* Diabetes requiring insulin treatment
Continuous Non-invasive Hemodynamic Monitoring in Early-onset Severe Preeclampsia: a Comparison of Echocardiography, Bioreactance, and Finger Cuff Measurements

The purpose of this study is to compare the feasibility and accuracy of two methods of non-invasive hemodynamic assessments - bioreactance as assessed by non-invasive cardiac output monitoring (NICOM; Cheetah Medical) and pulse wave analysis as assessed by finger cuff arterial pressure (ClearSite, Edwards Life Sciences) - compared to hemodynamic assessments by intermittent echocardiography in early onset preeclampsia.


Eligibility Criteria:
Inclusion Criteria:

* BP \>160 or DBP \>110
* gestational age between 20-34 weeks
* singleton pregnancy

Exclusion Criteria:

* prior diagnosis of chronic hypertension or hypertensive disorder of pregnancy
* multi-fetal pregnancy
Ax-003/Arimidex (Anastrozole) in the Adjuvant Therapy of Early Breast Cancer

The purpose of this study is the initial/followed by 5 year adjuvant therapy with Anastrozole.


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women with early hormone receptor positive breast cancer/no metastasis

Exclusion Criteria:

* None
Trigger Point Dry Needling In Patient With Patellofemoral Pain Syndrome

This study intends to determine the effects of trigger point dry needling in patients with Patellofemoral pain Syndrome.

This is a single blinded randomized controlled trial, will be conducted at District Head Quarter (DHQ) hospital Taunsa Sharif.

Dry needling is a technique used to release myofascial trigger points. this study is planned to determine the effects of dry needling on quadriceps muscle in patients with Patellofemoral pain syndrome. The sample size was calculated to be n=92 through Open Epi tool version 3, with 95 % confidence interval (CI), and power 80%,

After the completion of therapeutic protocols, the participants will be assessed with the help of Numeric Pain Rating Scale (NPRS), Algometer and Anterior Knee Pain scale along with knee Range of Motion(ROM)

Eligibility Criteria:
Inclusion Criteria:

* Males and females with age limit 20 to 40 years,
* Active knee extension/90-90 test positive for Screening (With AKE range less than 160 degrees),
* No known history of hip joint or knee joint disease,
* No history of recent hamstring strain.

Exclusion Criteria:

* Patient with meniscal tears, patellar tendinopathy, and ligamentous injuries.
* Patient with knee osteoarthritis
* Patient with lumbosacral nerve root or peripheral nerve involvement