cyrilzakka/clinical-trials huggingface dataset:
Kinesiotaping Method for Rib Fractures

Kinesiotaping is used as a physiotherapy method to reduce muscle pain. In this technique, kinesiotaping tapes are attached to the relevant parts of the body. Patients experience serious pain in rib fractures. Kinesiotaping technique can potentially reduce pain by contributing to external stabilization of the ribs. In this study, patients with isolated rib fractures will be divided into two groups. The first group will be treated with kinesiotaping technique and routine painkillers. The second group will receive routine painkiller treatment. Pain scores between both groups will be compared.


Eligibility Criteria:
Inclusion Criteria:

* Isolated thoracic injury within the last 24 hours
* Patients aged 18-100 years

Exclusion Criteria:

* Hemothorax and pneumothorax requiring intervention
* Injury severity index\>16
* Asthma and COPD
* Tape allergy
* Loss of consciousness (GCS \<15)
* Incapacitated patients
* Fracture of rib number 1-3
Everolimus in Combination With DHAP in Patients With Relapsed or Refractory Hodgkin Lymphoma

The purpose of this trial is

1. to determine the recommended dose of everolimus for a subsequent Phase II trial
2. to determine the efficacy of everolimus plus DHAP


Eligibility Criteria:
Inclusion Criteria:

* relapsed or refractory Hodgkin Lymphoma
* age 18-60
* histology confirmed relapse

Exclusion Criteria:

* previous therapy with mTOR inhibitor
* current CNS involvement
* other primary malignant disease within the last 3 years
Assessment of Pacing Stimulus Conduction and Latency Measurements in CRT-D Patients

The study is designed to collect data on LV latency in CRT-D patients by the CRT-D and compare measurements to 12-lead ECG data


Eligibility Criteria:
Inclusion Criteria:

* Patient has been implanted with a CRT-D device by BIOTRONIK at least 4 weeks before enrollment date
* Patient successfully implanted with a left ventricular lead
* High likelihood of LV latency ≥ 40 ms
* LV lead in lateral or postero-lateral position in the coronary venous system
* Patient is able to understand the nature of the clinical investigation
* Patient is willing to undergo the required measurements at the investigation site
* Patient provides written informed consent
* Age ≥ 18 years

Exclusion Criteria:

* Patients with irregular ventricular rhythm due to atrial tachycardia
* Pregnant or breast-feeding women
* Participation in an interventional clinical investigation
Short Term Effect of Liraglutide Versus Vildagliptine on Insulin Secretion and Insulin Sensitivity in Type 2 Diabetes

This is a single blind randomised controlled clinical trial in uncontrolled type 2 Diabetes mellitus patients on oral glucose lowering agents, and naive to incretinomimetic. Participants will be randomised in two Arms : arm 1 receiving Liraglutide at 1,2 mg/day and arm 2 Vildagliptine at 100mg/day over 14 days. The two arms will be compared for 14-day changes in insulin secretion and insulin sensitivity.

Incretinomimetics include exogenous Glucagon-Like Peptide analogs (GLP1a) such as Liraglutide, and inhibitors of Dipeptidyl peptidase IV (DPP4i) that prolong the half-life of endogenous GLP1 such as Vildagliptin. It remains unclear which of the two strategies (exogenous GLP1 or prolonging half-life of endogenous GLP1) have better short term effect on insulin sensitivity and insulin secretion in people living with type 2 diabetes.

This study aims to investigate the short-term metabolic effects of a GLP-1 analog Liraglutide versus a DPP4i Vildagliptin. It is a randomized, controlled, single-blinded clinical trial. Study population consists of uncontrolled type 2 diabetes mellitus patients (HbA1c≥7%) under mono or bi oral anti-diabetic therapy, naïve of any incretinomimetic treatment. Participants are randomized in 2 arms. The intervention in arm 1 consists of add-on subcutaneous Liraglutide at 0.6mg/day for 1 week increased to 1.2mg the second week. In the second arm, it consists of oral Vildagliptine at 100mg daily for two weeks. The primary outcome is the variation in euglycaemic hyperinsulinaemic clamp-derived insulin sensitivity before randomization and the day after intervention, secondary outcomes include 14-day changes in insulin secretion during a mixed meal tolarance test, body weight and body composition, and an indirect calorimetry measured resting energy expenditure. Changes from baseline to 14 days in serum creatinine and alanine amino transferase, C-reactive protein and lipid profile will also be recorded.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes mellitus known for at least one year
* Uncontrolled glycaemic profile with HbA1c ≥ 7% on oral antidiabetic mono or bi-therapy
* Naïve of incretinomimetic treatment
* Informed consent

Exclusion Criteria:

* Change in antidiabetic treatment less than 3 months prior to inclusion
* Pancreatitis
* Alanine amino transferase \> 3 times the normal values
* Pregnant or breastfeeding women
* Estimated glomerular filtration rate \< 60ml/min
* Infection less than 10 days prior to inclusion or during the study
* Acute complication of diabetes
* Total haemoglobin \< 11g/dL in women or \< 13g/dL in men
* Withdrawal of consent
Platelet Function in Resuscitated Patients-2

Approx. 65% of resuscitated patients at the intensive care unit for internal medicine are due to myocardial infarction. Almost all patients are initially diagnosed and treated in the cath lab. Therapy usually consists of one or more stent implantations. After implantation of a coronary stent, dual platelet inhibition is necessary for 12 months. Insufficient platelet inhibition causes an pronounced increase in risk of stent thrombosis. Therefore, secured inhibition and knowledge of the individual platelet function is valuable.

Patients after successful resuscitation associated to a myocardial infarction will be included into the study the morning after the index event. Patients get dual platelet inhibition using cangrelor as P2Y12 (purinergic G protein-coupled receptors-12) inhibitor plus acetylsalicylic acid (ASS). Patients are treated with therapeutic hypothermia according to the local Standard operating procedure for 24h and rewarming is performed within an additional 5 to 20h. Platelet function is measured every morning and ASS mediated as well as P2Y12 mediated platelet function inhibition is recorded. All relevant clinical data including APACHE (Acute Physiology and Chronic Health Evaluation) and SOFA (Sequential Organ Failure Assessment score) scores are collected.

The degree of platelet inhibition over time (4 days) and differences between the three drugs tested will be evaluated by optical aggregometry and by using the commercial VerifyNow test system.

Eligibility Criteria:
Inclusion Criteria:

* Myocardial infarction
* dual platelet inhibition
* resuscitation
* therapeutic hypothermia

Exclusion Criteria:

* none
Effect of Feldenkrais Method on Balance in Patients With Mechanical Low Back Pain

The goal of this clinical trial is to learn if Feldenkrais method affects balance in patients with mechanical low back pain. The main questions it aims to answer is:

does Feldenkrais method affects balance in patients with mechanical low back pain.

Participants will:

Be assessed for inclusion using slump and straight leg raise tests. Visit the clinic twice every week for sessions. Assessed pre and post treatment using Biodex Balance.

Sample size calculation showed that our sample is 40. Forty patients with mechanical low back pain not referring beyond the knee will be recruited from Souad Kafafi Hospital and multiple outpatient clinics in Giza, Egypt. Inclusion criteria is male or female patients, 18-45 years, mechanical pain for the last 6 months, with no previous surgeries or diseases in the spine. Treatment strategy include 10 treatment sessions for each allocated subject. Core strengthening exercises and Feldenkrais method (balance exercises) are the treatment approached used in this study. Two experienced physical therapists will apply the treatment in the Faculty of Physical therapy clinic. Overall, mediolateral, and anteroposterior stability will be assessed for each patient. The measurement will be done twice pretreatment and immediately after the last session.

Eligibility Criteria:
Inclusion Criteria:

* Mechanical back pain.
* Symptoms lasted for the last 6 months.
* Not referring beyond the knee.
* Mild to moderate pain in Numerical Pain Rating Scale and mild to moderate disability on Oswestry Disability Index

Exclusion Criteria:

* Spine Surgeries
* Chronic diseases
* Accidents and Fractures
A Clinical Study of TQB3823 in Patients With Advanced Malignant Tumor

This is a study to evaluate the maximum tolerated dose (MTD) , occurrence of all adverse events (AEs) and serious adverse events (SAEs) , pharmacokinetic parameters and antitumor effect of TQB3823 tablets in Chinese adult patients with advanced solid tumors .The study was divided into phase Ia and phase Ib, Phase Ia: Dose escalation period, to evaluate the safety and tolerability of TQB3823 tablets, determine MTD;Phase Ib: Effectiveness exploration period, to expand the safe and effective dose group, and to recommend appropriate dosage and method for subsequent clinical research.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects who voluntarily join the study, sign the informed consent form, and have good compliance.
2. Aged from 18 to 75 years; Eastern Cooperative Oncology Group (ECOG) performance status score: 0-1; at least 3 months expected survival period.
3. Subjects with relapse advanced malignant solid tumors clearly diagnosed by pathology and / or cytology, lack of conventional effective treatment methods.
4. The function of main organs is normal.
5. Subjects need to adopt effective methods of contraception.

Exclusion Criteria:

1. Subjects with other malignancies currently or suffered within 3 years. The following two conditions can be enrolled: other malignant tumors treated with a single operation to achieve disease-free survival (DFS) for 5 consecutive years; cured cervical carcinoma in situ, non-melanoma skin cancer and superficial bladder tumors\[ Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor infiltrating basement membrane)\].
2. Subjects with multiple factors affecting oral administration.
3. Subjets with unhealed toxicity above Grade 1 Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 due to previous antitumor treatment.
4. Subjects who have received major surgical treatment, open biopsy or obvious traumatic injury within 28 days before first administration.
5. Subjects with long lasting wounds or fractures.
6. Subjects with a history of psychotropic drug abuse unable to quit or with mental disorders.
7. Subjects with any severe and/or uncontrolled disease.
8. Subjects who have received surgery, chemotherapy, radiotherapy or other anticancer therapies 4 weeks before the first administration ( 2 weeks for brain radiotherapy ).
9. Subjects who have taken Chinese patent medicines with anti-tumor indications in the drug instructions that National Medical Products Administration (NMPA)approved within 2 weeks before the first administration.
10. Subjects with pleural effusion, pericardial effusion or ascites that cannot be controlled and need repeated drainage.
11. Subjects with known central nervous system metastases and/or cancerous meningitis.
12. Subjects who have participated in other clinical studies within 4 weeks before the first administration.
13. According to the judgment of the investigators, there are accompanying diseases that seriously endanger the safety of patients or affect the completion of the study.
A Prospective Study of Endothelial Dysfunction and Diabetic Foot Ulcer Risk

This project will identify risk factors for diabetic foot ulcer by studying the relationship between endothelial dysfunction and foot ulcer risk. A fundamental defect in type 1 and 2 diabetic subjects is impaired vasodilatory reserve which is reflected in the dysfunction of endothelium-dependent vasodilation. Findings thus far point to an important role of the microvasculature in the development of diabetic foot ulcer and amputation.

In this study a a well-characterized cohort of 750 diabetic veterans without foot ulcer will be followed over 3-years.

Prevention of foot ulcer should result in a reduction in the risk of lower limb amputation. We propose to identify risk factors for diabetic foot ulcer by studying the relationship between endothelial dysfunction and foot ulcer risk. It has been proposed that impaired vasoregulation in diabetic patients leads to the development and perpetuation of chronic foot ulceration via failure of the normal hyperemic response to injury. A fundamental defect that has been demonstrated in type 1 and 2 diabetic subjects is impaired vasodilatory reserve, which reflects dysfunction of endothelium-dependent vasodilation. Our findings thus far point to an important role of the microvasculature in the development of diabetic foot ulcer and amputation, with our demonstration of higher foot ulcer and lower-limb amputation risk in relation to lower dorsal foot transcutaneous oxygen level. The role of endothelial dysfunction in relation to diabetic foot ulcer risk has not previously been studied.

We will follow a well-characterized cohort of 750 diabetic veterans without foot ulcer over 3-year after obtaining baseline measures of endothelial function using iontophoretic application of acetylcholine to induce cutaneous endothelium-dependent vasodilation on the dorsal foot. Iontophoresis permits noninvasive delivery of ionic drugs cutaneously without damage to the skin or systemic effects. Change in microvascular flow will be measured using a laser Doppler imager (Moor LDI) over a 4x4 cm area divided into 18496 measurement sites. Endothelial function will be defined as the difference between readings before and after the iontophoretic application of a 1% acetylcholine solution at a current of 0.2 mA for 1 minute, with higher readings reflecting better endothelial function. These techniques are the accepted standard method for assessment of endothelium-dependent vasodilation in the cutaneous microvasculature. Additional measurements will be obtained on other ulcer risk factors to assess whether endothelial dysfunction independently influences foot ulcer risk, or whether it is merely a marker for different pathophysiologic conditions responsible for higher risk (eg., sensory neuropathy). Possible confounding factors considered will include sensory and autonomic neuropathy; dorsal foot transcutaneous oximetry; macrovascular function assessed with Doppler blood pressures; diabetes characteristics; in-shoe plantar pressure (F-scan), medication use, and foot deformity.

Eligibility Criteria:
Diabetic patients with foot ulcers
Artificial Intelligence Supported Case Analysis on Nursing Education

Background: Rapid developments in the field of artificial intelligence have begun to necessitate changes and transformations in nursing education.

Objective: This study aimed to evaluate the impact of an artificial intelligence-supported case created in the in-class case analysis lecture for nursing students on students' case management performance and satisfaction.

Design: This study was a randomized controlled trial. Method: The study involved 188 third-year nursing students who were randomly assigned to either the AI group (n=94) and control group (n=94). An information form, case evaluation form, knowledge test, and Mentimeter application were used to assess the students' case management performance and nursing diagnoses. The level of satisfaction with the case analysis lecture was evaluated using the VAS scale.


Eligibility Criteria:
Inclusion Criteria:

* having taken nursing process lecture before
* having planned care for at least one surgical patient in clinical practice before
* having a mobile phone with internet connection

Exclusion Criteria:

* not attending the case analysis lecture
* not being an active student
* incomplete completion of the data collection forms
* not accepting to participate in the study
Mesenchymal Stem Cell Secretome In Severe Cases of COVID-19

This study is a multi-centre randomized controlled trial involving severe covid-19 patients. The intervention group will receive mesenchymal stem cell secretomes and standard covid-19 therapy, while the control group receive placebo and standard covid-19 therapy. Clinical presentation, inflamatory marker, laboratory and radiological parameters, RT-PCR conversion, safety profile, and mortality rate will be monitored for a maximum of 14 days after intervention.


Eligibility Criteria:
Inclusion Criteria:

1. All individuals aged 18 to 65 years
2. It has been confirmed positive for COVID-19 by throat swab / sputum / brochoalveolar lavage (BAL) with real-time reverse transcription polymerase chain reaction (RT-PCR)
3. Categorized as a severe case of COVID-19 patient
4. Agree to participate and sign the informed consent

Exclusion Criteria:

1. History of allergy to penicillin, streptomycin, and amphotericin-B
2. Have any cancer conditions
3. Active in other intervention studies
4. Have had other intervention studies in the last 3 months
Long-term Follow-Up for RGX-121

RGX-121-5101 is the long-term follow-up study to the RGX-121-101 first in human study where participants received RGX-121, a gene therapy intended to deliver a functional copy of the iduronate-2-sulfatase gene (IDS) to the central nervous system. This study will evaluate the long-term safety and efficacy of RGX-121.

This is a prospective follow-up study to evaluate the long-term safety and efficacy after a single administration of RGX-121. Eligible participants are those who previously have enrolled in clinical study RGX-121-101 and received a single intracisternal (IC) or intracerebroventricular (ICV) infusion of RGX-121. Enrollment of each participant will occur the same day or after the participant has completed the end of study (EOS) visit or early termination visit (ET) from the previous (parent) study. Participants will be followed in this study cumulatively for up to 5 years after RGX-121 administration (inclusive of the parent study) or until RGX-121 is commercially available in the participant's country, whichever occurs first. No treatment will be directed under this observational protocol. The total study duration for each participant may vary depending on when they enroll in the current study following RGX-121 administration in the parent study.

Eligibility Criteria:
Inclusion Criteria:

* To be eligible, a participant must have previously received RGX-121 in a separate parent trial.
* Participant or participant's legal guardian(s) is/(are) willing and able to provide written, signed informed consent

Exclusion Criteria:

* Patient has not received RGX-121 previously in a separate parent trial.
An Observational Study of Erlotinib (Tarceva) as Second-line Treatment in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer After Failure of Pemetrexed in First-line Therapy

This prospective, multicenter observational study will evaluate the efficacy, safety, and tolerability of Tarceva (erlotinib) as second-line treatment in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have progressed after pemetrexed-containing first-line chemotherapy. Eligible patients will be followed until withdrawal of consent, lost-to-follow-up, or study termination, whichever occurs first.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients ≥ 18 years of age.
* Histologically or cytologically documented locally advanced or metastatic non-small cell lung cancer (inoperable Stage III or IV according to the 7th TNM Classification of Malignant Tumors).
* Experiencing disease progression after pemetrexed-containing first-line chemotherapy regimen.
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
* Initiated on second-line treatment with Tarceva at the most 4 weeks prior to study entry at baseline (date of signature of informed consent).

Exclusion Criteria:

* Prior chemotherapy/targeted therapy after disease progression after first-line treatment in the advanced non-small cell lung cancer (NSCLC) setting.
* Contraindication for Tarceva according to the Summary of Product characteristics.
Fentanyl and Crushed Ticagrelor in Percutaneous Coronary Intervention

During a percutaneous coronary intervention (PCI), Fentanyl is commonly used for sedation. Ticagrelor is also routinely used as anti-platelet agent during PCI. However, a recent study has demonstrated the decrease in effectiveness of Ticagrelor when administered along with Fentanyl. Hence this study was designed to further assess the interaction between crushed vs non crushed Ticagrelor and Fentanyl given during PCI procedures.


Eligibility Criteria:
Inclusion Criteria:

* Undergoing clinically indicated elective or non-elective PCI
* Able to swallow oral medications

Exclusion Criteria:

* Contraindications to ticagrelor or fentanyl (or other opiates)
* Pregnancy
* Any use of P2Y12 inhibitors within 14 days
* Known coagulation disorders
* Pre-procedural treatment with an anticoagulant (oral anticoagulant or low molecular weight heparin)
* Platelet count \< 100,000/mm3
* Impaired renal function (Estimated glomerular filtration \< 45 ml/min/1.73 m2)
* Impaired hepatic function (Based on medical history)
* Prior or planned transcatheter aortic valve replacement
Effectiveness of Pain Neuroscience Education (PNE) to Veterans With Post-Traumatic Stress and Low Back Pain

This trial compared traditional pain and stress education plus physical therapy to pain neuroscience education plus physical therapy in individuals with post-traumatic stress and chronic low back pain.

Veterans and Service Members with low back pain (LBP) will be recruited for this research. Once Veterans consent to participate in this research, participants will undergo baseline testing. Next, participants will randomly be assigned to one of two types of education: pain neuroscience education or traditional biomedical education. Each Veteran will receive 30 minutes of interactive education once a week for 4 weeks, depending on their group assignment. Following each education session, Veterans will participate in an exercise class that will last approximately 30 minutes. After the 4 week intervention, Veterans will complete the same questionnaires and measures as at the beginning of the program. Veterans will also complete subjective questionnaires at 8 weeks. Finally, healthcare utilization will be measured for 12 months following the research intervention.

Eligibility Criteria:
Inclusion Criteria:

* Pain located between the 12th rib and buttocks that in the opinion of the screening examiner is originating from the lumbar region
* Current episode of back pain duration of 3 months or longer
* Active duty military or Veteran
* Read and speak English well enough to provide informed consent and follow study instructions

Exclusion Criteria:

* History of prior surgery to the lumbosacral spine within the previous 12 months
* Presence of neurogenic LBP defined by a positive contralateral straight leg raise (reproduction of symptoms below 45 degrees) or reflex, sensation, or strength deficits in a pattern consistent with nerve root compression
* Medical "red flags" of a potentially serious condition including cauda equina syndrome, major or rapidly progressing neurological deficit, fracture, cancer, infection, or systemic disease
* Discharged from physical therapy within the past 3 months for lower back pain
* Current diagnosis of psychotic conditions or medications (bi-polar, schizophrenia, personality disorder).
* Substance abuse or psychosis within 6 months of research.
* Unable to discontinue other active therapies until completion of clinical trial follow-up (8 weeks).
* Suicidal ideation
* Current pregnancy