cyrilzakka/clinical-trials huggingface dataset:
PGI2 Versus Nitroglycerine for Management of Pulmonary Hypertension After Valve Surgeries

This study was conducted in 120 patients aged from 54-65 years scheduled for elective valve replacement surgeries. Patients were randomly allocated to nitro glycerine or PGI2 groups. Patients of nitro glycerine group received nebulized nitro glycerine at a rate of 2.5-5 mcg/kg/min (5 mg, 1 mg/ml) over 10 minutes by ultrasonic nebuliser. Patients of PGI2 group received nebulized PGI2 (epoprostenol), 20000 ng/ml (20000 ng/ml in 60 ml syringe was attached to an intravenous pump which delivers a titrating rate of 8 ml/h . The primary outcome was mean pulmonary artery pressure. The secondary outcomes included mean arterial blood pressure (MAP) (mmHg), PaO2/FiO2 ratio, cardiac index (CI) (l/min/m2) right ventricular ejection fraction (RVEF), central venous pressure(CVP) , 30-day mortality rate and the incidence of complications such as facial flushing, hypotension and re-exploration for bleeding.

Postoperative pulmonary hypertension (PHT) is the most challenging complication of valvular heart disease about 73% of the patients particularly in those posted for mitral valve replacement surgery Methods This prospective study was conducted in 120 patients aged from 54-65 years scheduled for elective valve replacement surgeries. Patients were randomly allocated to either nitro glycerine or PGI2 groups. Patients of nitro glycerine group received nebulized nitro glycerine (its starting concentration was 200 mcg/ml); nitro glycerine was delivered at a rate of 2.5-5 mcg/kg/min (5 mg, 1 mg/ml) over 10 minutes by ultrasonic nebuliser connected to the inspiratory limb of the breathing circuit. Patients of PGI2 group received nebulized PGI2 (epoprostenol), 20000 ng/ml (20000 ng/ml in 60 ml syringe was attached to an intravenous pump which delivers a titrating rate of 8 ml/h to the nebulizer compartment. The primary outcome was mean pulmonary artery pressure. The secondary outcomes included mean arterial blood pressure (MAP) (mmHg), PaO2/FiO2 ratio, cardiac index (CI) (l/min/m2) right ventricular ejection fraction (RVEF), central venous pressure(CVP) measured at the end of cardiopulmonary bypass then 30 minutes after start of treatment then 4 hours after start of treatment, 30-day mortality rate and the incidence of complications such as facial flushing, hypotension and re-exploration for bleeding.

Eligibility Criteria:
Inclusion Criteria:

* 35 to 66 years old
* elective valve replacement surgery
* pulmonary arterial hypertension

Exclusion Criteria:

* Emergency surgery
* severe renal and hepatic dysfunction
* uncontrolled supraventricular arrhythmia
* those requiring preoperative inotropes
Minimally Invasive Procedure Versus Conservative Treatment in the Management of Calcaneal Joint Fractures

Calcaneal fractures, which affect the heel bone, are the most common type of tarsal fractures and often occur in young people, leading to long recovery times and significant social and economic consequences. Traditional treatments include either non-surgical methods, like immobilizing the foot in a cast, or open surgery, which involves a large incision to fix the bone with plates. However, open surgery has a high complication rate, including issues with wound healing. Recent advances have introduced minimally invasive surgical techniques, which use smaller incisions and have shown better results with fewer complications. This study aims to compare two treatment options for displaced calcaneal fractures: a minimally invasive surgery group and a non-surgical treatment group using a plaster boot. The goal is to determine whether minimally invasive surgery provides better outcomes for patients, such as faster recovery, fewer complications, and improved long-term function, to guide future treatment practices. Thus, this is a prospective, randomised comparative study of the management of articular fractures of the calcaneus: conservative treatment versus minimally invasive surgery.


Eligibility Criteria:
Inclusion Criteria:

1. Patient aged 18 or over
2. Patient with a posterior articular fracture of the calcaneus Sanders II to IV, less than 15 days old
3. Patient affiliated to a social security scheme,
4. Patient having given written consent following written and oral information.

Exclusion Criteria:

1. Patient with open calcaneal fracture
2. Patient with bilateral calcaneal fracture
3. Patient with extreme varus or valgus impingement of the fibula
4. Patient with associated talar, tibial, femoral and/or pelvic fracture or associated spinal cord injury.
5. Patient unsuitable for loco-regional anaesthesia (LRA).
6. Patient with neuro-psychiatric disorders resulting in an inability to follow a post-surgical or post-immobilisation rehabilitation protocol.
7. Pregnant women
8. Patient protected by law under guardianship or curatorship, or unable to participate in a clinical study under article L. 1121-16 of the French Public Health Code.
Clinical Evaluation of Genetron Lung Cancer Panel in Non-small Cell Lung Cancer Patients

The purpose of this trail is to evaluate the performance of Genetron lung cancer panel in non-small cell lung cancer patients using semiconductor sequencing method.

This trial follows the principle of synchronous blinding. The enrolled cases are coded, and the enrolled samples are detected with Genetron lung cancer panel and comparison methods. The detection results are compared, and the samples that are inconsistent with the detection results of similar products on the market are reviewed by the the Sanger sequencing method, when the site detection results compared with Sanger sequencing method are inconsistent, Sanger's detection results are recognized. The safety and effectiveness of this panel are confirmed and evaluated. Meanwhile, the accuracy of this panel for the following drug companion diagnostic tests: EGFR gene 19 exon deletion and L858R point mutation in gefitinib tablets, erlotinib hydrochloride and icotinib hydrochloride tablets, T790M point mutation in methanesulfonate acid osimertinib tablets, ALK gene fusion in crizotinib capsules.

The results were determined independently according to the cutoff values or interpretation requirements provided by each method, and relevant statistics were used to evaluate clinical application performance of Genetron lung cancer panel.

Eligibility Criteria:
Inclusion Criteria:

1. Cancer samClinically diagnosed as non-small cell lung samples (mainly lung adenocarcinoma and some lung squamous cell carcinoma, adenosquamous carcinoma, large cell carcinoma, etc.), and a small number of other cancer types are enrolled as interference samples.
2. Collect some samples of relevant medical information before and after the use of targeted drugs. This part of the samples should have relevant previous molecular diagnosis results.
3. Able to provide samples in time according to the requirements of the plan: samples for DNA/RNA extraction: 10 pieces of 10 µm thickness for each sample or 10 pieces of paraffin rolls. Samples for FISH experiment: 5 slices of 3-4µm thickness.
4. The pathological examination conforms to the types of tissue samples listed in the above table. The HE staining results show that the tumor content is not less than 50%, and the paraffin slice damage should be avoided.
5. The sample should have corresponding basic clinical information, including: patient visiting number/medical record number/specimen number, age, gender, pathological diagnosis result, molecular diagnosis result (if any).

Exclusion Criteria:

* Those who do not meet any of the above conditions are excluded. Reason: The included non-small cell lung adenocarcinoma samples and normal samples should have statistical significance, and the conclusions obtained should be scientific and valid. The selection of subjects for this study, while excluding research-related influencing factors, has no adverse effect on the health of the subjects.
Using Optical Coherence Tomography (OCT) to Evaluate the Efficacy and Safety of PEGylated Interferon Beta-1a (BIIB017) in Patients With Relapsing Multiple Sclerosis

This research sub-study is being completed as a part of the Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of PEGylated Interferon Beta-1a (BIIB017) in Subjects with Relapsing Multiple Sclerosis (Protocol #: NA_00028117). This substudy is being done to understand the efficacy of BIIB017 by measuring the nerve fiber thickness in the eye.


Eligibility Criteria:
Inclusion Criteria:

* Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations.
* A participant in the ADVANCE study aged 18 to 55 years old, inclusive, at the time of informed consent

Exclusion Criteria:

* As per the ADVANCE main study
* History of intraocular surgery, retinal disease, glaucoma, or diabetes
* Refractive errors of more than ±6.0 diopters
* Inability to tolerate OCT procedure
Assessment of Community Transmission of Sabin Type 2 Virus in Bangladesh

The Strategic Advisory Group of Experts on Immunization (SAGE) has set a plan to replace trivalent oral polio vaccine (tOPV) with bivalent OPV (bOPV) plus inactivated polio vaccine (IPV) in routine immunization globally, to be instituted in 2015-2016. At the community level, the impact of the change from tOPV + IPV to bOPV + IPV on Sabin virus fecal-oral transmission (duration of circulation, degree of genetic reversion) and the persistence of environmental contamination are unknown. Also unknown is the impact of the change from tOPV to bOPV on community circulation of Sabin 2 after a special immunization (SI) activity with monovalent oral poliovirus type 2 (mOPV2). Finally it is unknown at the level of an individual child if type 2 fecal shedding will be limited by cross-protection from oral vaccination with Sabin type 1 and 3.

The investigators propose to measure at a community level transmission of Sabin 2 virus in Bangladesh, a low income country, where fecal-oral transmission and environmental exposures are high, comparing transmission in the setting of vaccination with tOPV+IPV vs. bOPV+IPV. The study will be conducted in 67 villages in Matlab, Bangladesh, using a cluster-randomized study design. Villages in Matlab will be randomly assigned to receive as part of routine immunization (RI) activities: (1) tOPV (6,10,14 weeks) plus IPV at 14 weeks; (2) bOPV (6,10, 14 weeks) plus IPV at 14 weeks; or (3) bOPV (6,10, 14 weeks) plus IPV at 14 and 18 weeks. Community and environmental surveillance for Sabin 2 virus will be conducted in each village over the 9 month period of these RI activities. In addition, a SI activity with mOPV2 will occur 9 months into the study to model an outbreak response. For the 6 months following the mOPV2 challenge, the impact of the different vaccination regimens on Sabin 2 transmission in the community will be determined, as well as individual level protection (as measured by fecal shedding from days 7-70 after mOPV2 challenge).


Eligibility Criteria:
Inclusion Criteria:

* A male or female infant at least 6 weeks of age (42-48 days) at the time of enrollment
* For the Special Immunization Activity (SIA) only, being age 5 years or younger at the time of the SIA
* An infant whose parent or guardian's primary residence, at the time of first Expanded Program on Immunization (EPI) vaccinations, is a village selected to receive polio vaccine.
* Written informed consent obtained from the parent or guardian of the participant, prior to the participants's first study vaccination

Exclusion Criteria:

* History of prior polio vaccination (in the 810 infants enrolled at 6 weeks of age only)
* Hypersensitivity to the active substance or any component in the vaccine
* Subjects with uncorrected congenital malformation
* Infants with known or suspected immunodeficiency
Micronutrients in Children in Critical Care With Cardiac Conditions

This study aims to explore the frequency and types of micronutrient deficiencies in a sample of UK children with CHD using standard and novel markers in blood. The study will also explore whether micronutrient deficiencies increase the risk of complications after heart surgery. This study will identify any nutrient deficiencies that need monitoring in clinical practice.

Congenital heart disease (CHD) is one of the most common birth defects in the UK. Children with CHD are at risk of underfeeding and undernutrition. This is due to both the increased nutritional requirements of the disease and sometimes clinical management, which often hinders delivery of optimal nutrition.There are as yet no studies assessing micronutrient body stores in children with CHD or whether micronutrient deficiencies predict poor clinical outcomes, such as post-operative complications, after major cardiac operations.

This study aims to explore the frequency, types and associations of micronutrient deficiencies in children with CHD using standard and novel markers in blood. The study will also explore whether micronutrient deficiencies increase the risk of complications after heart surgery. This study will identify any nutrient deficiencies that need monitoring in clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* Infant or child admitted for elective congenital cardiac surgery at the Royal Hospital for Sick Children, Glasgow.
* Aged less than 5 years old

Exclusion Criteria:

* Infant or child admitted for emergency cardiac surgery
* Infant or child whose carer with parental responsibility is unable to communicate in English
Effect of Combined Intra-articular Injection of Lidocaine Plus Physiotherapy in Treatment of Frozen Shoulder

1. Therapeutic exercise, especially stretch exercise and joint mobilization, remain the mainstay of conservative treatment of frozen shoulder.

   1. Nevertheless, shoulder pain during the physiotherapy reduces the treatment effect.
   2. Manipulation or arthroscopic release under general anesthesia may avoid pain during the intervention; however, increased risk of humeral shaft fracture and failure of release of pathological tissue were reported.
2. We consider intra-articular injection is a compromized way, from a practical point of veiw, to reduce the pain during physiotherapy.
3. We hypothesize that, intra-articular injection with lidocaine before joint mobilization and stretch exercise, can make the patient pain-free during physiotherapy, and the effect of combined therapy is superior to physiotherapy alone in the treatment of frozen shoulder.

A randomized controlled trial to compare the effect in treatment of frozen shoulder between combined intra-articular injection with lidocaine plus physiotherapy and physiotherapy alone.

Eligibility Criteria:
Inclusion Criteria:

* Clinically diagnosed as unilateral frozen shoulder, with the definition as more than 50% loss of passive movement of the shoulder joint relative to the non-affected side, in one or more of the three movement direction (ie. abduction in the frontal plane, forward flexion in sagittal plane, or external rotation in 0 degree of abduction)
* Duration of complaints of more than three months
* Ability to complete questionnaires in Chinese

Exclusion Criteria:

* History of shoulder fracture, dislocation, or trauma
* History of Rheumatic arthritis, tumor, or other diseases in the shoulder joints
* Receive intra-articular corticosteroid injection or manipulation therapy in shoulder joint in recent four weeks
* Pregnancy or breast feeding
* Allergic to lidocaine
Observational Study With Investigation of Two Second Generation Laryngeal Masks

In a observational study the second-generation laryngeal masks LMA Supreme and Ambu AuraGain are investigated.

After approval from the local ethics committee, data were collected in a prospective, non- randomised study over a three-month period. When contra-indications for laryngeal mask use were absent anaesthesiologists used either Supreme (Teleflex Medical GmbH, Germany) or Gain (Ambu GmbH, Germany). Endpoints were the success rate and time to insertion.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 Years
* No concurrent participation in another study
* capacity to consent
* Present written informed consent of the research participant
* Elective surgery under general anesthesia

Exclusion Criteria:

* Age \<18 years
* Existing pregnancy
* Lack of consent
* inability to consent
* emergency patients
* Emergency situations in the context of a Difficult Airway Management
* ASA classification\> 3
* situations where the possibility of accumulated gastric contents
* Participation in another study
L-citrulline and Metformin in Becker's Muscular Dystrophy

The purpose of the study is to compare the effects of L-citrulline and metformin and their combination therapy on muscle function and force in patients with Becker muscular dystrophy (BMD).

This is a single center, not-randomized open study. The study medication consists of L-citrulline and metformin administered orally; 5g citrulline and 500mg metformin tablets will be given 3 times daily.

Half of the patients will be treated with metformin during the first 6 weeks of the study. The other patients will receive initially L-citrulline for 6 weeks, before all patients will be treated with the combination therapy (metformin and L-citrulline) for another 6 week period.

The study lasts 12 weeks and includes the screening visit and 3 further visits at baseline, week 6 and week 12.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Molecular or immunohistochemical diagnosis of BMD
* ambulant at the time point of screening

Exclusion Criteria:

* Participation in another therapeutic BMD study within the last 3 months
* Use of L-Arginine, L-Citrulline or Metformin within the last 3 months
* Other chronic disease or relevant limitation of renal, liver, heart function according to discretion of investigator
* known hypersensitivity to L-citrulline or metformin
KF2022#4-trial: Effects of a Beta Blocker and NSAID on CYP Mediated Drug Metabolism

Carvedilol is a non-selective beta-blocker in common clinical use, used to treat hypertension, heart failure, and angina pectoris symptoms associated with coronary artery disease. Diclofenac is a non-selective anti-inflammatory drug in general use, which is used to treat rheumatic diseases, osteoarthritis, musculoskeletal pain conditions, menstrual pains and migraines, among others. In our recent experiments involving liver cell enzymes, both carvedilol and diclofenac were found to inhibit several cytochrome P450 (CYP) enzymes central to drug metabolism, potentially leading to adverse drug interactions with other drugs metabolized by the same enzyme. The purpose of this study is to investigate the effects of the use of carvedilol and diclofenac on the activity of key CYP enzymes in drug metabolism in healthy volunteers using a low-dose model drug combination covering seven CYP enzymes.

In an open three-phase, randomized, crossover study with 12 healthy volunteers, the subjects will receive a drug combination of caffeine, bupropion, repaglinide, flurbiprofen, omeprazole, dextromethorphan, midazolam and simvastatin and as a premedication either placebo, carvedilol or diclofenac. Blood samples will be collected and carvedilol, diclofenac, caffeine, bupropion, repaglinide, flurbiprofen, omeprazole, dextromethorphan, midazolam and simvastatin pharmacokinetics will be monitored up to 23 hours post dose.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Age 18-40
* Healthy
* Systolic blood pressure ≥110 mmHg
* Heart rate ≥ 55/min
* Normal ECG
* Accepted results from laboratory tests (blood haemoglobin, basic blood count and blood platelets, alanine aminotransferase, alkaline phosphatase, glutamyl transferase, creatine kinase, creatinine, plasma glucose concentration, plasma potassium and sodium). Negative pregnancy test result (serum human chorionic gonadotropin) for women.

Exclusion Criteria:

* Significant disease
* Previous or current gastrointestinal bleeding, ulcer or perforation
* Findings of a medical examination and laboratory tests, which require a more detailed examination of the state of health
* Smoking
* Hormonal birth control or other regular medication
* Pregnancy (current or planned) or nursing
* Participation in any other studies involving investigational or marketed drug products within three months prior to the entry into this study
* Donation of blood within three months prior to the entry into this study
* Significant overweight / small or hard-to-find veins
* BMI \< 18.5 kg/m2
* Insufficient Finnish language skills
* Hypersensitivity or contraindication to study drugs
The CT-verified Data Collection Study to Investigate the Correlation Between the Leadless Pacemaker Tip Location and Echo, ECG

The goal of this observational study is to assess inter-/intra- ventricular synchrony and ECG characteristics in relation to Micra tip location.

The secondary objective is (1) to identify an optimal Micra pacing location to improve LV function, (2) to investigate the correlation between Micra tip location and tricuspid regurgitation, and (3) to investigate whether Micra location would impact AV synchrony. Patients with pacing indications who plan to receive Micra AV implantation will be recruited.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged above 18 years old
* Patients who are willing to provide Informed Consent
* Patients with Class I or II indications who plan to receive a leadless pacemaker, including SSS, AVB, AF with bradycardia, etc.
* Patients who plan to conduct a cardiac CT scan after implantation

Exclusion Criteria:

* Patients with lead retention
* Patients had heart valve replacement
* Patients diagnosed with ischemic heart diseases
* Patients who are allergic to or refuse to use contrast in CT scans
* Patients who are pregnant or have a plan for pregnancy during the study
* Patients with medical conditions that would limit study participation
* Patients already enrolled in another clinical trial which would impact participation of this study