cyrilzakka/clinical-trials huggingface dataset:
Comparison Study of Oxytocin Versus Tranexamic Acid and Etamsylaye Versus Placebo(Saline)

Comparison Study Between Oxytocin Versus Tranexamic Acid and Ethamsylate Versus Normal Saline as Pre-operative Administration.

Comparison Study Between Oxytocin Versus Tranexamic Acid and Ethamsylate Versus Normal Saline to reduce intra operative bleeding and postoperative bleeding during elective Cesarean Delivery.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant females admitted for Elective Cesarean Section.
* Gestational age of pregnancy (38 weeks To 40 weeks).
* the average height of 145 to 160 cm,average body weight of 45 to 85 kgs.
* Singleton living fetus.
* No medical disorders.
* Informed Oral Consent From The Patient.

Exclusion Criteria:

* Severe medical and surgical disorders as thyroid dysfunction, which was excluded by routine thyroid function test (free T3, free T4, and thyroid stimulating hormone(TSH), all of them should be within normal limits).
* Bleeding tendency, for example, disseminated intravascular coagulopathy, which was excluded by platelet count, coagulation time, bleeding time, prothrombin time, partial thromboplastin time, and thrombin time (all should be within normal).
* Acute liver or kidney diseases; blood disorders, such as anaemia.
* Allergy to Tranexamic acid.
* Risk factors for PPH, such as polyhydramnios, fetal macrosomia, antepartum haemorrhage.
* Ante partum Hemorrhage such placental abruption.
Efficacy and Safety of BI 1356 BS (Linagliptin) in Combination With Metformin in Patients With type2 Diabetes

The objective of the study is to test the efficacy, safety and tolerability of several doses of BI 1356 BS (1, 5, or 10 mg taken once daily) compared to placebo given for 12 weeks together with metformin in patients with type 2 diabetes mellitus who are not at goal with their HbA1c levels. In addition, there will be an unblinded treatment arm with glimepiride as add-on therapy to metformin for comparison. The influence of several factors (gender, age, weight, race, etc.) on the bioavailability and efficacy of BI 1356 BS will also be tested in this study.


Eligibility Criteria:
Inclusion criteria:

Inclusion_Criteria:

* Male and female patients with a diagnosis of type 2 diabetes mellitus and previo usly treated with metformin alone or with metformin and one other oral antidiabetic d rug
* HbA1c 7.0 9.0% at screening for patients treated with metformin and one other oral antidiabetic drug
* HbA1c 7.5 10.0% at screening for patients treated with metformin alone
* HbA1c 7.5 10.0% at beginning of the placebo run-in phase
* Age \> 21 and \< 75 years
* MI \> 25 and \< 40 kg/m2 (Body Mass Index)

Exclusion criteria:

Exclusion_Criteria:

* Clinically relevant cardiovascular disease
* Impaired hepatic function
* Renal insufficiency or impaired renal function
* Treatment with rosiglitazone or pioglitazone within 6 months prior to screening
* Treatment with insulin within 3 months prior to screening
Phase III, Open-label, Study of First-line Dato-DXd in Combination With Rilvegostomig for Advanced Non-squamous NSCLC With High PD-L1 Expression (TC ≥ 50%) and Without Actionable Genomic Alterations

The purpose of this study is to evaluate efficacy and safety of Dato-DXd in combination with rilvegostomig or rilvegostomig monotherapy compared with pembrolizumab monotherapy as a first line therapy in participants with locally advanced or metastatic non-squamous NSCLC with high PD-L1 expression (TC ≥ 50%) and without actionable genomic alterations.

This is a Phase III, randomized, open-label, Global Study of Datopotamab Deruxtecan (Dato-DXd) in Combination With Rilvegostomig or Rilvegostomig monotherapy versus Pembrolizumab monotherapy for the first-line treatment of participants with locally-advanced or metastatic non-squamous NSCLC with high PD-L1 expression (TC ≥ 50%) and without actionable genomic alterations.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically documented non-squamous NSCLC.
* Stage IIIB or IIIC or Stage IV metastatic NSCLC (according to Edition 8 of the AJCC staging manual) not amenable to curative surgery or definitive chemoradiation.
* Absence of sensitising EGFR mutations, and ALK and ROS1 rearrangements, and absence of documented local test result for any other known genomic alteration for which there are locally approved and available targeted first-line therapies.
* Must provide tumor sample to determine PD-L1 status, TROP2 status and other biomarkers.
* Known tumour PD-L1 expression status defined as TC ≥ 50%
* At least one lesion, not previously irradiated that qualifies as a RECIST 1.1 target lesion at baseline
* ECOG performance status of 0 or 1
* Adequate bone marrow reserve and organ function within 7 days before the first dose of study intervention

Exclusion Criteria:

* Prior systemic therapy for advanced/metastatic NSCLC.
* Squamous cell histology, or predominantly squamous cell histology NSCLC; mixed small cell lung cancer; NSCLC histology, sarcomatoid variant.
* History of another primary malignancy within 3 years
* Active or prior documented autoimmune or inflammatory disorders (with exceptions)
* Any evidence of severe or uncontrolled systemic diseases, including, but not limited to active bleeding diseases, active infection, active ILD/pneumonitis, cardiac disease.
* Has clinically significant third-space fluid retention (for example pleural effusion) and is not amenable for repeated drainage.
* History of non-infectious ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or has suspected ILD/pneumonitis that cannot be ruled out by imaging at screening
* Has significant pulmonary function compromise, as determined by the investigator
* Spinal cord compression, or brain metastases unless participant treated and no longer symptomatic, radiologically stable, and who require no treatment with corticosteroids or anticonvulsants.
* History of leptomeningeal carcinomatosis
* Known clinically significant corneal disease
* Active infection with TB, HBV, HCV, Hepatitis A, or known HIV infection that is not well controlled
* History of active primary immunodeficiency
Nursing and Pharmacy Care Between Capecitabine and 5-Fluoruracil Regimens

The objective of this study is to compare the possible time savings from reduction of nursing and pharmacy time to manage AEGC patients using capecitabine-based regimens versus traditional intravenous chemotherapy in the Hong Kong public hospital setting.

Advanced esophageal and gastric cancer (AEGC) have ranked in the top 10 cancer-related cause of death worldwide, with approximately one million new cases each year. Over half of new cases are in East Asia. The traditional chemotherapy for AEGC remains on intravenous (IV) fluorouracil (5-FU), cisplatin, and the anthracyclines. Trials favoured the combined use of 5-FU and cisplatin for superior efficacy and quality of life in AEGC patients. Recent years, oral chemotherapy has a more practical and economic advantages over IV regimen. It is understandable that patients prefer oral regimens as long as the clinical efficacy is maintained. Oral treatment strategy preserves quality of life for AEGC patients. In addition, it may also have additional cost saving in the nursing and pharmacy time. It is because a significant amount of time can be saved in both nursing and pharmacy for the preparation and administration of IV chemotherapy However, there is a lack of local data to demonstrate the impact of pharmacy and nursing care utilizing capecitabine-based regimen comparing to traditional IV chemotherapy in MCRC patients of Hong Kong.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 18 or above
2. Diagnosed with AEGC and were prescribed with either XELOX-based or FOLFOX4- based chemotherapy treatment

Exclusion Criteria:

1. Persons \< 18 years of age;
2. Pregnant or lactating women;
3. Persons related unequally to investigators (e.g. student, employee);
4. Special population (e.g. prisoner, mentally, congnitively disabled);
5. Patients who refused to sign consent or not willing to participate.
A Study of Vinflunine in Patients With Gastric Cancer

The purpose of this study is to learn if vinflunine can shrink or slow the growth of cancer in patients with advanced or metastatic stomach cancer who have progressed on a prior treatment with a fluoropyrimidine or taxane-containing chemotherapy regimen. The safety of this treatment will also be studied.


Eligibility Criteria:
Inclusion Criteria:

* Patients with locally advanced or metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction who have progressed on a fluoropyrimidine or taxane-containing regimen in any combination in one prior first line treatment.
* EGOC performance status of 0,1 or 2
* Men and women, 18 years of age and older

Exclusion Criteria:

* Patients having received more than one previous systemic chemotherapy regimen in any setting.
* Major abdominal surgery within 2 months or any other surgery under general anesthesia within 4 weeks
* Unresolved occlusive or sub-occlusive intestinal disease or any significant chronic intestinal disease (e.g. ulcerative colitis)
* Prior radiation to \>=30% of the bone marrow and/or radiation within 4 weeks prior to enrollment
* Acute or chronic hepatitis
* Known HIV infection
* A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval \>450 ms
* A history of additional risk factors for Torsade de Pointes (e.g., heart failure hypokalemia, family history of Long QT Syndrome)
Bamberg Diabetes Transitional Care Pilot Study

Bamberg County residents who has been diagnosed with or is at high risk for diabetes, may be eligible for a clinical research study to improve diabetes self-management and decrease hospital re-admissions.

The purpose of this study is to compare the effectiveness of three hospital discharge follow-up methods:

1. standard of care,
2. a nurse telephone intervention (care coordination and education), and
3. an in-home community health worker intervention (care coordination and education).


Eligibility Criteria:
Inclusion Criteria:

* Bamberg County resident
* between 18 and 75 years of age
* a patient discharged from the Regional Medical Center emergency department or Regional Medical Center hospital within 72 hours prior to consent
* diagnosed with diabetes or at high risk for diabetes
* will be a Regional Medical Center patient for follow-up care
* speaks English
* has access to a phone

Stage 2 Recruitment:

* If recruitment at 3 weeks after the first patient is enrolled is \< 15 or the recruitment at 12 weeks is \< 45, additional inclusion criteria will include the following: Regional Medical Center outpatient or unassigned community member with uncontrolled diabetes (defined as A1C \>8 or blood pressure \>140/90) is uninsured or who self-reports problems with obtaining medications.

Exclusion Criteria:

* end-stage renal disease
* terminal illness (e.g., advanced cancer, end-stage chronic obstructive pulmonary disease, advanced dementia)
* incarceration
* resident in a skilled nursing home.
Impact of Premedication on Anxiety

IMPACT aims to evaluate the clinical routine practice of premedication in German hospitals and to estimate the influence of premedication on anxiety reduction.

Generalised premedication with benzodiazepines in all surgical patients has become questionable, regarding the risk-benefit assessment and the lack of evidence for this practice. One of the main justifications for premedication with benzodiazepines is its anxiolytic effect. Anxiety is associated with postoperative cognitive and behavioural changes, physiological reactions, increased need of anaesthetic drugs and altered perception of pain, mood swings, wound-healing problems and alteration of the immune system. However, several investigations revealed negative side-effects like dose-dependent sedation up to respiratory depression, prolonged extubation-time, impaired psychomotor function, paradox reactions, antegrade amnesia, increased pneumonia rates and postoperative delirium.

In Germany midazolam is the most frequently administered premedication. A survey revealed that about one third of the German hospitals withhold a premedication in patients older than 74 years.

The evidence for this practice, as well as the indiscriminate preoperative premedication for all adult patients is low.

The investigators aim to recruit as many as possible centers throughout Germany, to participate in this study. A total sample size of 4000 patients will provide reasonable and valid results for the study aims. The influence of premedication on the primary endpoint change of APAIS-score will be analysed by a multivariable analysis of covariance considering several baseline characteristics. In case of significant interaction terms, subgroup analysis will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Only legally competent patients
* Written informed consent prior to study participation
* Age ≥18 years, both genders
* Elective surgery
* Expected surgery duration ≥ 30 minutes
* Planned general or combined regional and general anaesthesia
* Planned extubation (or removal of airway device) at the end of surgery

Exclusion Criteria:

* Age \<18 years
* Non-fluency in German language
* Alcohol and/ or drug abuse
* Chronic benzodiazepine treatment
* Intracranial surgery
* Local or solely regional anaesthesia
* Monitored anaesthesia care/ Sedation
* Cardiac surgery
* Ambulatory surgery
* Repeated surgery with previous participation in the trial
* Expected continuous mandatory ventilation after surgery
* Patients with severe neurological or psychiatric disorders
* Refusal of study participation by the patient
Fluid-removal Guided by VeXUS Score With Usual Care in Patients With Acute Kidney Injury After Cardiac Surgery

Acute kidney injury affects more than 30% of patients after cardiac surgery, and is associated with an excess in mortality. There is a clinical continuum between acute kidney injury (transient if \<48h, persistent if \>48h), the development of acute kidney and chronic renal failure. Each of these entities characterising renal recovery is associated with an increase in long-term morbidity and mortality. Fluid management in patients with acute kidney injury is challenging, as both hypovolaemia and hypervolaemia are detrimental. Venous congestion (reflecting intravascular hypervolaemia), is a well-established haemodynamic factor contributing to acute kidney injury after cardiac surgery. An ultrasound score, based on the venous doppler pattern explored in intra-abdominal organs, has recently been developed and is a better predictor of acute kidney injury than central venous pressure. Whether using the VeXUS score to guide fluid removal in haemodynamically stabilised patients could promote renal recovery after acute kidney injury remains to be investigated.

Before designing a large randomised trial to test such a strategy, its feasibility in a pilot randomised trial is assessed.


Eligibility Criteria:
Inclusion Criteria:

* Intensive care unit admission within 72 hours of cardiac surgery with extracorporeal circulation
* Acute kidney injury defined by KDIGO criteria
* Vasoactive inotropic score \<45 and capillary refill time \<3s
* Informed written consent

Exclusion Criteria:

* Hypokalaemia \<3.5mmol/L
* Hyponatremia\<125mmol/L
* Hypernatremia \>145mmol/L
* Metabolic alkalosis with pH \>7.50
* Impossibility to measure capillary refill time
* Chronic liver disease
* Cirrhosis with portal hypertension
* Known thrombus of the inferior vena cava
* Mechanical circulatory assistance (ECMO or mono left ventricular assistance)
* Severe pre-operative chronic kidney disease (GFR \< 30mL/min/1.73m2)
* Need for renal replacement therapy anticipated by the attending physician within 24 hours
* Known hypersensitivity to Furosemide and/or hydrochlorothiazide
* Severe allergy to wheat
* Patient already included in another interventional study with an exclusion period still in progress
* Pregnant, breast-feeding or women of childbearing age without suitable contraception
* Patients under guardianship, curatorship or safeguard of justice
* Patients under psychiatric care
* Patients not affiliated to a social security scheme or beneficiaries of a similar scheme
Virtual Reality Distraction During Arteriovenous Fistula Puncture

The cannulation of arteriovenous fistula is a painful procedure in hemodialysis patients. Previous studies have shown the effectiveness of virtual reality in reducing pain during needle-related procedures

Patients undergoing hemodialysis experience anxiety and pain related to the insertion of hemodialysis needles, estimated 320 times in total per year. The pain experienced is mostly caused by needle insertion into a fistula. Pain control is one of the main nursing tasks. Pain relief leads to the acceptance of the procedure and ultimately enhances the patients' quality of life. The use of virtual reality to reduce pain and anxiety during the arteriovenous fistula cannulation procedure is based on the concept that the perception of pain can be controlled because an individual is able to process only a limited amount of information at once. As such, the use of virtual reality during painful procedures may serve as a distraction.

Eligibility Criteria:
Inclusion Criteria:

* patients who are under- going conventional hemodialysis three times a week
* hemodialysis period of one month or more
* having a healthy AVF access with good function
* welling to participate in study

Exclusion Criteria:

* patients who have psychiatric diseases
* panic disorder, anxiety disorder
* dysfunctional fistula
* vertigo, issues with sight, hearing, or perception
* or use painkillers within three hours before hemodialysis
Prognostic Analysis of Esophageal Cancer with Complete Pathological Response After Neoadjuvant Therapy

Esophageal cancer is one of the most common malignant tumors worldwide, with high invasiveness and lethality. Currently, the treatment for resectable locally advanced esophageal cancer mainly consists of a treatment model centered on surgical treatment with the participation of multiple disciplines. Neoadjuvant treatment regimens include chemotherapy, chemoradiotherapy, and chemotherapy combined with immunotherapy. Complete pathological response (pCR)is currently regarded as one of the important indicators for evaluating the efficacy of neoadjuvant treatment. Previous studies have shown that 14%-39% of patients with complete pathological response after neoadjuvant treatment still experience recurrence and metastasis within two years after surgery, suggesting that pCR after esophageal cancer surgery does not mean clinical cure. Perhaps there is a highly risk clinical subgroup need to research. Therefore, based on the prospective clinical database of the National Cancer Center and in cooperation with multiple national cancer regional medical centers, this study analyzes and explores the prognosis of patients with locally advanced esophageal squamous cell carcinoma with pCR after neoadjuvant treatment, characterized by the Chinese population.


Eligibility Criteria:
Inclusion Criteria:

* Patients treated neoadjvant treatment followed by esophagectomy from 2018 to 2023
* Patients with thoracic esophageal squamous cell carcinoma
* The preoperative clnical stage is cT1N+M0/cT2-4aN0-3M0, with potential resectability
* Patients with complete pathological response (ypT0N0M0)
* Without distant metastasis was found in the preoperative examinations, and the tumor did not directly invade the pancreas, spleen, trachea, aorta or other adjacent organs such as the lungs

Exclusion Criteria:

* Patients with previous history of malignant tumors
* Patients with multiple primary cancers
* Deficient neoadjuvant treatment or salvage surgery
* Incomplete clinical data
Effects of Long-term Foam Rolling Compared to Static Stretching on Hamstring Muscle Flexibility

The purpose of this study to to compare the long-term effects of foam rolling in comparison to static stretching and a control group on hamstring flexibility. The investigators hypothesize that participants in the foam rolling and static stretching group will demonstrate increased flexibility to the control group, but will a difference will not be observed between the foam rolling and static stretching groups.


Eligibility Criteria:
Inclusion Criteria:

* Active 90/90 hamstring length goniometric measurement of greater than 10 degrees at baseline
* Active straight leg raise of less than 90 degrees

Exclusion Criteria:

* History of lower extremity injury including but not limited to sprain, strain, fracture, or any surgical intervention that lead to a decrease in activity greater than two weeks within the last six months
* Current involvement in a lower extremity flexibility program outside of their regular activity
Oxygen Concentration During Alveolar Recruitment

The purpose of this study is to investigate the effect of oxygen concentration during alveolar recruitment on absorption ateletasis.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing laparoscopic obstetric or colon surgery with Trendelenburg position

Exclusion Criteria:

* American Society of Anesthesiologists physical status IV or more
* Severe cardiovascular disease
* Severe chronic obstructive pulmonary disease, emphysema
* History of pneumothorax, bullae
* History of lung resection surgery
* Conversion to laparotomy
* Refusal to participate
Changes in Plantar Preassures and Ankle Range of Motion After the Technique of Neuromeningeal Mobilization

Neuromeningeal mobilization or neurodynamics is a movement-based technique whose purpose is to restore peri- and intraneural homeostasis (1). It is based on principle that nerves have to lengthen and shorten to maintain normal muscle tension and range of motion (1) This technique has been shown to be effective in recovering tissue mobility (2), reducing pain in low back pain (3) and neck pain (1) and pain intensity in the elderly, and increasing joint range of motion and muscle flexibility (4 )

Regarding balance, sciatic nerve sliding has been shown to immediately improve balance to one leg ( dinamic balance) after application in a comparative study before and after (4,5)

No study has been realised in for the Posterior Tibial, Deep Peroneal, Medial Dorsocutaneous and Lateral Nerves, and no study has verificated standing balance and range of motion in ankle joint

The study will consist of recording before and after applying the nerve mobilization exercise. Measurements will be made on the same day without the need to go at another time.

In this study, participants will be asked to stand on a pressure platform several times in a relaxed manner and with eyes open and closed before and after a neuromeningeal mobilization technique indicated for the treatment of pain in your feet. In addition, the mobility of the ankle will be measured with the knee flexed and stretched. The measurements or tests to be carried out are totally innocuous and do not carry any risk to your health and integrity.

Participants will have to remain barefoot for a maximum of 30 seconds, a total of 8 times on a pressure platform

Eligibility Criteria:
Inclusion criteria:

-Participants who arrived at the clinic presenting with pain in both heels and who were diagnosed with active or latent MTrP in bilateral flexor digitorum brevis, (2) these specific MTrPs were the only MTrPs diagnosed in limb or foot, (3) all participants had a normal body mass because obesity can affect plantar pressure distribution \[28\], and (4) and had an age range of 27.96 to 36.04 (95% confidence interval \[CI\]) because body mass could also affect plantar pressures.

Exclusion Criteria:

* (1) Diagnosis of lower limb injury, such as plantar fasciitis, tendinopathy, bursitis, ligament injuries \[27\], (2) a history of previous lower extremity surgery \[28\], (3) participants were required not to have undergone ankle stretching or any other treatment \[23\], (4) diabetes due to possible elevation of plantar pressure, \[30\], (5) deformities of the toes, such as hammer toes and hallux valgus due to their possible alteration in plantar pressure.