cyrilzakka/clinical-trials huggingface dataset:
Double Flap Technique for Macular Hole

Double flapping technique to close the macular hole.

Recently, it is agreed to close the macular hole with the retinal innermost layer; which is called internal limiting membrane (ILM), in most cases, the hole closes. But, sometimes the ILM single flap might displace resulting in a persistent hole.

Therefore, the investigators tried to make two flaps utilizing ILM, and sometimes certain patients have a very thin membrane over the retina; it is called epiretinal membrane (ERM). The investigators use the double flapping technique by utilizing ERM; therefore, the ILM remains and can be used if the hole resists closing with the first surgical interventions.

Here, the investigators did not use any new materials with unknown side effects on the human retina. Although the flap technique is well known; however, investigators are making a double flap to decrease the chance of persisting macular holes.

The visual recovery will be appeared in the post-operative period, whether it is the same, better, or worse.

Eligibility Criteria:
Inclusion Criteria:

* Full thickness macular hole

Exclusion Criteria:

* Partial-thickness macular hole
* Vitreomacular traction
Cardiac MRI in Ischemic Stroke Study

The purpose of this prospective single-center trial is to compare the safety and diagnostic value of contrast medium-enhanced cardiac magnetic resonance imaging and transesophageal echocardiography in patients with acute ischemic stroke.

Primary safety objective: Contrast medium-enhanced cardiac magnetic resonance imaging is safe in patients with acute ischemic stroke. Primary outcome: The diagnostic value of contrast medium-enhanced cardiac magnetic resonance imaging is comparable to transesophageal echocardiography in patients with acute ischemic stroke.

Eligibility Criteria:
Inclusion Criteria:

* Patients with acute ischemic stroke detected by brain magnetic resonance imaging.

Exclusion Criteria:

* Known atrial fibrillation or cardiac source of embolism
* Severe aphasia
* Acute infection or chronic inflammation
* Severe arteriosclerosis or stenosis of brain-supplying arteries
* Contraindications for magnetic resonance imaging or transesophageal echocardiography.
Regulatory Post Marketing Surveillance Study in Korea

The objective of the study is to investigate and collect post marketing data on the safety and efficacy of Visanne at follow-up visit after about 6 months of treatment and - for a subset of patients - at optional long-term follow-up visit after about 1 year of treatment under daily practice treatment conditions in Korean women and to obtain data on drug utilization on treatment for endometriosis.


Eligibility Criteria:
Inclusion Criteria:

* Signed and dated informed consent
* Women diagnosed by a physician as having endometriosis
* Women who are prescribed Visanne(dienogest 2mg)for the first time during the study period

Exclusion Criteria:

- All contraindications according to the local marketing authorization have to be considered.
Uroflowmetry in Children With Enuresis Nocturnal

Background: Enuresis nocturna is an important social and psychological problem in children. Uroflowmetry is an important test used to investigate lower urinary tract symptoms..

Objective:To evaluate the uroflowmetry (UFM) results of children with nocturnal enuresis (NE).

Method:

The uroflowmetry findings of healthy and visualized children without any urinary symptoms and who were prospectively admitted to the urology and pediatric surgery outpatient clinic with the complaint of Enuresis nocturna between January 2020 and July 2021 were compared. Information (anamnesis, physical examination, radiology results and laboratory tests) and uroflowmetry results of NE and healthy children included in the study were recorded.

SMale and Female,

Eligibility Criteria:
Inclusion Criteria:

Primer monosymptomatic enuresis nocturna

Exclusion Criteria:

Urinary infectious Diabetes Spina bifida, Epispadias, Hipospadias VUR Extrophia Vesica Epilepsy Cerebral Palsy
A Study in Korea of Entecavir Versus Lamivudine in Adults With Chronic Hepatitis B Infection

Entecavir, 0.5 mg daily, will have clinical efficacy (assessed as an undetectable hepatitis B DNA, \<300 copies/mL, by Roche Comprehensive Bio-Analytical System Amplicor polymerase chain reaction assay) that is comparable (noninferior) and potentially superior to lamivudine, 100 mg once daily, in adults with hepatitis B e antigen-negative chronic hepatitis B virus infection.


Eligibility Criteria:
Inclusion Criteria:

* Nucleoside and nucleotide-naive subjects with chronic HBV infection
* Hepatitis B Surface antigen(HBsAg)-positive ≥6 months
* Detectable HBsAg
* HBV DNA ≥ 105 copies/mL by PCR
* ALT 1.3 to 10 x the ULN
* HBeAg negative, anti-hepatitis B Virus E antigen antibody (anti-HBeAb) positive status
Electrical Signal Collection From a 20 Pole Catheter During Routine Cardiac Procedures

Routine data collection will be conducted during normal sinus rhythm and AV synchronous pacing for approximately 20 minutes. The data collected will then be processed and the P, R and T wave amplitudes will be measured.

The purpose of this study is to collect atrio-ventricular electrograms using a sequence of tip-ring spacings in patients undergoing routine cardiac procedures (EP study, pacemaker/ICD/CRT implant). To collect these signals, a 20 pole catheter (Medtronic StableMapr intracardiac steerable electrode catheter) will be acutely placed in the RV apex during a routine cardiac procedure.

Routine data collection will be conducted during normal sinus rhythm and AV synchronous pacing for approximately 20 minutes. The data collected will then be processed and the P, R and T wave amplitudes will be measured.

Eligibility Criteria:
Inclusion Criteria:

* Subjects aged 18 or above, or of legal age to give consent specific to the national law of the countries in which the study is being conducted

  * Subjects who are undergoing a cardiac procedure where routine placement of cardiac catheter can be performed
  * Subjects are willing to provide Informed Consent

Exclusion Criteria:

* • Subject has exclusion criteria per local law and regulations (e.g. age, breast feeding, etc)

  * Any condition which precludes the subject's ability to comply with the study requirements
  * Subject has physical conditions that contraindicate the use of the device per approved labeling, including but not limited to active sepsis, known sensitivity to heparin, cannot undergo standard anticoagulation protocol for cardiac procedure, blood clotting abnormalities or a recent coagulopathy or embolic event, venous filtering device (Greenfield Filter) and obstructed or damaged vessel
A Registry for Patients Treated on the Clinical Trial TAX 3503

The purpose of this study is to continue follow-up on patients who were treated on the study called TAX 3505 (MSK IRB #07-101). The sponsor of this study, has decided to end the study early, before all patients have completed all planned follow-up tests. As a result, the investigators do not yet know whether hormonal therapy alone, or in combination with docetaxel, is better at preventing prostate cancer recurrence in patients who had a rising PSA after prostatectomy. This study will continue following patients according to a schedule that is similar to that found in the TAX 3503 (MSK IRB #07-101) study in order to answer that question. This study is known as a registry study. The patients' will not receive any treatment as part of this study. Instead, they will be asked to have a blood test performed once every 12 weeks.


Eligibility Criteria:
Inclusion Criteria:

* The registry will include the database of all patients registered to TAX3503. Those patients who will be prospectively tracked through the registry are those who meet the following criteria:

  1. The patient must have been registered to TAX3503
  2. The patient must not have met the definition of progression as defined in TAX3503 while on TAX3503 Patients who have progressed or hit their 36 month post treatment date between the closure of TAX3503 and the activation of this TAX3503 Registry protocol will be permitted on the study to capture their date of progression or their 36 month post treatment progression free date.

Exclusion Criteria:

* Patients who were not registered to TAX3503 are not eligible to have their data stored in this registry.
A Study of Liposomal Trans Crocetin, LEAF-4L6715, in Patients With Acute Respiratory Distress Syndrome Due to COVID-19, Sepsis or Other Causes

This is an open label phase II study of treatment with LEAF-4L6715 in patients who experience severe acute respiratory distress syndrome (ARDS) due to COVID-19, Sepsis or other Causes. The purpose of this study is to evaluate the improvement in PaO2/FiO2 by more than 25% in patients treated with LEAF-4L6715.

Patient is treated with LEAF-4L6715, a liposomal transcrocetin. The liposomal formulation allows for a gradual release of the free drug, thereby facilitating less frequent dosing.

Pharmacokinetic assessment will be carried out to identify an optimal dose and schedule.

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent from the patient or patient's legal representative must be obtained prior to any procedures, as the likelihood of patients being able to provide consent is very limited
2. Patients must be ≥ 18 years old
3. Patient must have acute respiratory distress syndrome as defined, with a PaO2/FiO2 ratio of less than 200 mm Hg
4. Patient must be under artificial ventilation support (including patient under OptiflowTM Nasal High Flow device or an equivalent device)
5. Patient must have a life expectancy of at least 24 hours
6. Patients should have normal liver function as defined by ALT, AST and alkaline phosphate less than 3 ULN for the institution
7. Patient must have platelet count above \>100,000 cells/mm3, hemoglobin \> 8 g/dL and an absolute neutrophil count (ANC) of \> 1000 cells/mm3
8. Patients requiring dialysis due to renal impairment in cohort 3

Exclusion Criteria:

1. Patient is enrolled in any other therapeutic clinical trial with the same endpoints. All observational studies or study with limited invasive methods (Pharmacokinetic studies, monitoring of virus charges studies, biological monitoring studies ....) are allowed
2. Patient is pregnant or breast-feeding
3. Patient has a known hypersensitivity to crocetins, LEAF-4L6715 or any of its excipients
4. Patients with hemoglobinopathy
5. Patients receiving extracorporeal membrane oxygenation (ECMO)
Tube 1st Technique for Easy Fiberoptic Intubation

the aim of this work is to study how this technique will make nasal fiberoptic intubation easier and faster than the usual classic technique

Difficult intubation is one of the most significant issues anesthesiologists deal with, occasionally. Among these, mandibulofacial deformities face the biggest challenge in intubation and make an anticipated difficult airway (1), due to short length of mandible (HLM), short thyromental distance (TMD), short inter horizontal -incisors gap (IIG) and high grade modified Mallampati test (MMT) (2).

There are several strategies to approach these patients and each technique has unique benefits that should be used on experience. Sitting endotracheal intubation is a useful technique for airway control, in patients with difficult airway or in patients in whom maintenance of the upright posture is beneficial (3), A difficult airway is defined as difficulty with facemask ventilation, difficulty with tracheal intubation, or both (3). According to new updates on difficult airway management, by the American Society of Anesthesiologists, there are non-invasive and invasive interventions for the management of difficult airway. Non-invasive interventions include, without being limited to: awake intubation, video-assisted laryngoscopy, intubating stylets or tube-changers, supraglottic airway (SGA) for ventilation (e.g., LMA, laryngeal tube), SGA for intubation (e.g., ILMA), rigid laryngoscopic blades of variousdesign and size, fiberoptic-guided intubation, and lighted stylets or light wands, while invasive interventions include surgical or percutaneous airway, jet ventilation and retrograde intubation (4).

Attaching a nasal airway to a breathing circuit as a tool to assist or control ventilation is a very helpful trick to have in challenging airway management situations.

Typically, Fiberoptic bronchoscope is passed through the more patent nostril to follow the major nasal pathway at the floor of the nose along the superior aspect of the hard palate, the lateral aspect of the nasal septum inferior to the lower turbinate to reach the nasopharynx where the operator identifies the pharyngeal structures, such as the base of the tongue and/or the epiglottis that are mostly "in-fall" precluding clear views of the larynx requiring a jaw thrust to visualize the laryngeal structures for patients planned to be intubated under general anesthesia \[5,6\].

Eligibility Criteria:
Inclusion Criteria:

1. Age between 20 and 60 years,
2. ASA Class I\& II,
3. Maxillofacial surgeries ex: mandibular surgery, orthognathic surgery and dental extraction surgery,
4. Other surgeries like: oral graft surgery, facial trauma, limited mouth opening ex: submandibular and facial abscess.

Exclusion Criteria:

1. Patient's refusal,
2. ASA III or more,
3. Intrinsic and idiopathic coagulopathy,
4. known allergy to any of the study medications,
5. furthermore, patients were excluded if they had severe hypoxemias due to sever cardiac or lung disease
Analgesics in the Pre-hospital Setting: Implications on Hemorrhage Tolerance - Ketamine

The purpose of this project is to test how ketamine, an analgesics currently employed in the pre-hospital setting by the US Army, alters the capacity to tolerate a hemorrhagic insult in humans.

Pain management on the battlefield is critical for the wellbeing of the soldier. Given that a hemorrhagic injury on the battlefield is virtually always associated with pain, it is paramount that the selected pain medication does not disrupt appropriate physiological mechanisms that are beneficial towards the maintenance of blood pressure and vital organ blood flow during that hemorrhagic insult. Current guidelines for the selection of pain medications of a hemorrhaging soldier are based upon limited scientific evidence, with the vast majority of supporting studies being conducted on anesthetized animals. Thus, the interaction between hemorrhagic shock and pain medications commonly employed on the battlefield is yet to be determined in the conscious humans.

With this background, we will test the hypothesis that ketamine will impair the capacity for a conscious human to tolerate a hemorrhagic insult.

The obtained data will provide the necessary scientific evidence in humans to support the Committee on Tactical Combat Casualty Care (CoTCCC) guidelines on the analgesic of choice for moderate to severe injuries where the casualty is in hemorrhagic shock. Notably, such data will identify the analgesic that least compromises a human's ability to tolerate a hemorrhagic insult, ultimately providing critical information to the combat medic on which analgesic should be employed for such an injury.

Eligibility Criteria:
Inclusion Criteria:

* 18-45 years of age
* Healthy
* Non-obese (body mass index less than 30 kg/m2)
* Body mass greater than or equal to 65 kg

Exclusion Criteria:

* Subjects not in the defined age range
* Subjects who have cardiac, respiratory, neurological and/or metabolic illnesses
* Any known history of renal or hepatic insufficiency/disease
* Pregnancy or breast feeding
* Body mass less than 65 kg
* Current smokers, as well as individuals who regularly smoked within the past 3 years
* Positive urine drug screen
* Currently taking pain modifying medication(s)
Biofeedback Gait Training on Gait Quality in Stroke

Post-stroke gait dysfunction is characterized by reduced gait velocity and stride length, along with gait asymmetry and instability. Gait asymmetry and instability are considered as indicators for gait quality, which affect independence and quality of life in individual with stroke. Previous studies have suggested that gait biofeedback is a promising strategy for enhancing the efficacy of post-stroke gait training. However, there is insufficient evidence on the effects of kinematic biofeedback gait training on gait asymmetry and instability in individuals with stroke. Therefore, the purpose of this study is to investigate the effects of real-time kinematic gait biofeedback training on gait quality in individuals with stroke.


Eligibility Criteria:
Inclusion Criteria:

* First stroke
* Stroke onset time ≥ 6 months
* Functional Ambulation Category ≥3
* Passive range of motion of affected hip extension is at least 10 degrees
* Mini-Mental State Measurement score ≥ 24 points

Exclusion Criteria:

* Modified Ashworth Scale of affected ankle plantar flexors ≥ 2
* Muscle strength of affected ankle plantar flexors via Manual Muscle Testing ≤ 1
* Uncorrected auditory impairment
* Severe cardiovascular disease or uncontrolled hypertension
* Other orthopedic diseases that may affect walking ability
* Other neurological disease except stroke
Neoadjuvant Study of Pyrotinib and Trastuzumab Plus Docetaxel and Carboplatin in HER2 Positive Breast Cancer Patients.

Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER-1 and HER-2 receptors.This study is a single-arm, prospective, open label clinical study for evaluating the efficacy and safety of neoadjuvant pyrotinib and trastuzumab plus docetaxel given as neoadjuvant treatment in HER2 positive early stage or locally advanced breast cancer.

Neoadjuvant therapy is the standard treatment for locally advanced breast cancer and is used to reduce tumors to make them operable, and to increase breast-conserving rates. In recent years, the anti-HER2 treatment mode, which is double-blocked by a combination of dual-targeted drugs, has obtained clinical approval in adjuvant therapy and neoadjuvant therapy. Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER-1 and HER-2 receptors. Based on previous clinical studies, we designed the study to explore the possibility of Pyrotinib in combination with Trastuzumab plus Docetaxel given as neoadjuvant treatment in HER2 positive early stage or locally advanced breast cancer.

Eligibility Criteria:
Inclusion Criteria:

1. female patients, 18 years ≤ age ≤ 75 years.
2. Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1.
3. Histologically confirmed invasive breast cancer（early stage or locally advanced）:Primary tumour greater than 2 cm diameter
4. HER2 positive (HER2+++ by IHC or FISH+)
5. Life expectancy of more than 3 months
6. Known hormone receptor status.
7. Required laboratory values including following parameters: ANC: ≥ 1.5 x 10\^9/L;Platelet count: ≥ 100 x 10\^9/L;Hemoglobin: ≥ 9.0 g/dL;Total bilirubin: ≤ 1.5 x upper limit of normal (ULN);ALT and AST: ≤ 1.5 x ULN (or ≤ 5×ULN in patients with liver metastases);BUN and creatine clearance rate: ≥ 50 mL/min;LVEF: ≥ 50%;QTcF: \< 470 ms for female and \< 450 ms for male.
8. Signed the informed consent form prior to patient entry.

Exclusion Criteria:

1. metastatic disease (Stage IV) or inflammatory breast cancer.
2. Previous or current history of malignant neoplasms, except for curatively treated:Basal and squamous cell carcinoma of the skin,Carcinoma in situ of the cervix.
3. clinically relevant cardiovascular disease:Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarction, uncontrolled hypertension ≥180/110);
4. Unable or unwilling to swallow tablets.
Clinical Study of MG-K10 Humanized Monoclonal Antibody Injection in Healthy Adult Subjects

Research Topics A randomized, open-label, parallel-group, phase I clinical trial comparing the pharmacokinetics of MG-K10 humanized monoclonal antibody in healthy adults

Objectives of the Study

Main objective: To compare the pharmacokinetics of MG-K10 after a single subcutaneous injection in healthy Chinese adult subjects.

Secondary objectives: To evaluate other pharmacokinetic (PK) parameters of MG-K10 after a single subcutaneous injection; The safety and tolerability of a single subcutaneous injection of MG-K10 in healthy Chinese adult subjects were evaluated. To evaluate the immunogenicity of MG-K10 in healthy Chinese adult subjects.

design: The number of cases in this trial was set as 30 cases in test drug (T) group and 30 cases in control drug (R) group, and a total of 60 subjects were enrolled.

Eligibility Criteria:
Inclusion Criteria:

1. Participants signed the informed consent form before the study, and fully understood the content, process and possible adverse reactions of the study; Volunteer to participate and be able to complete the study in accordance with the protocol requirements.
2. Chinese healthy adult volunteers, male or female, aged 18-50 years old (inclusive) at the time of signing the informed consent form;
3. During the screening period, the body weight of male volunteers was ≥50 kg; Body weight of women ≥45 kg, and body weight of men and women must not exceed 80 kg (including 80 kg); Body mass index (BMI) in the range of 19.0-26.0kg/m2 (including the boundary value;
4. From the date of signing the informed consent to 6 months after the end of the trial, the volunteers (including male volunteers) had no plans to have children and voluntarily took effective non-drug contraceptive measures, and had no plans to donate sperm or eggs.

Exclusion Criteria:

1. Have any clinically serious disease history or are currently suffering from related diseases, including but not limited to diseases of the digestive system, cardiovascular system, respiratory system (such as asthma, etc.), urinary system, musculoskeletal system, endocrine system, neuropsychiatric system, blood system, immune system and other systems; Have any disorders such as coagulopathy (e.g. hemophilia) or a history of haemorrhagic diseases such as hemorrhoids, acute gastritis or gastric and duodenal ulcers; Patients with severe ocular diseases or acute ocular inflammation (conjunctivitis, blepharitis, keratitis, etc.), dry eye or pruritus; Have herpes virus infection;
2. Those who have participated in and used the trial drug;
3. Lactating and pregnant women, or women of childbearing age volunteers with positive blood pregnancy test;
4. Had a history of dizzy with needles and blood; Or patients with orthostatic hypotension；
5. Patients who had used immunosuppressant or immunopotentiator within 3 months before drug administration;
6. There are birthmarks, scars, tattoos, open wounds at the administration site (around the umbilical cord);