cyrilzakka/clinical-trials huggingface dataset:
A Trial of Complete Versus Selective HepaticVascular Clamping in Hepatectomy

Intraoperative bleeding remains a major concern during liver resection. Pringle maneuver is the most frequently used method to occlude inflow blood of the liver.However, experimental and clinical studies have shown than even short periods of clamping produce some degree of ischemia-reperfusion injury that can result in hepatocellular damage,this damage being especially important in patients with abnormal liver parenchyma such as steatosis and cirrhosis. The aim of this study was to evaluate whether the use of selective vascular clamping should be generalized to HCC patients and help to reduce the ischemia-reperfusion injury.

From recent animal studies, it can be easily concluded that I/R injury of the liver may be a significant factor, which can promote the primary liver tumor recurrence and metastasis. If it is a truth in human, there must be a big challenge to the Pringle maneuver which was adopted routinely in hepatectomy in the past years. Pringle maneuver during hepatic resection may do harm to the liver function, make the tumor cell more aggressive and tend to recurrence. It is suggested that further strategies may be needed for the prevention and treatment of I/R injury ,early and late recurrences.Selective hepatic vascular clamping (SVC)such as hemihepatic vascular occlusion have been used to minimize ischemic injury during liver surgery, especially in patients with abnormal liver parenchyma. However,these procedure used is likely to depend on the surgeon's training or preference rather than on objective data, there is not any further reported data or RCT studies conducted about the postoperative outcome ,especially liver function.To address these issues,we designed a prospective randomized controlled trial comparing the complete hepatic vascular clamping (Pringle maneuver) and selective hepatic vascular clamping ( portal vein or hemi-hepatic occlusion) in patients undergoing hepatectomy. The main objective was to compare the liver I/R injury of two procedures to the postoperative liver function. The secondary objective was to evaluate the feasibility, safety, efficacy, amount of hemorrhage,postoperative complications ,disease-free and overall survival rate of the 2 procedures.

Eligibility Criteria:
Inclusion Criteria:

1. with a clinical diagnosis of primary liver cancer, without any adjuvant therapy;
2. age:18-70years;
3. suitable for partial hepatectomy without other malignancies;
4. compensated cirrhosis with Child-Pugh class A, or B.

Exclusion criteria:

1. reject to attend；
2. with any preoperative adjuvant therapy.
3. with intrahepatic or extrahepatic malignancies;
4. cirrhosis with Child-Pugh class C
Prospective Clinical Evaluation of ASR/Re-Cap Resurfacing Arthroplasty

ASR/Re-cap versus 28 MoM


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of THA
* ASA I-II
* Willing to return for follow-up evaluations

Exclusion Criteria:

* Collum femurs \< 2 cm
* Cysts \> 1 cm
* Caput necrose
Swallowing Exercises for Nasopharyngeal Cancer After Radiation Therapy

This study is designed to investigate the treatment efficacy of 8 weeks swallowing exercise programs for patients with NPC after radiation therapy. This study also compares two different swallowing exercise: effortful swallow and Mendelsohn's maneuver, to see which one can bring more benefits to patients after a certain period of exercise training. Three assessment tools are selected to evaluate the study result: Mann Assessment of Swallowing Ability (MASA), videofluoroscopic swallowing study (VFSS), and Chinese version Swallowing Quality-of-Life Questionnaire (CSWAL-QOL). The hypothesis of this study is that the effortful swallowing exercise would have better treatment efficacy.


Eligibility Criteria:
Inclusion Criteria:

* patients diagnosed with NPC
* completed radiation therapy at least 1 year
* mild to moderate swallowing disorder defined by videofluorography
* able to comply with protocal mandate, willing to perform the exercise programs, and ability to attend the weekly sessions

Exclusion Criteria:

* feeding tube insitu
* received pharyngeal surgery
* tracheostomy tube insitu
* patients who could not put effort to push posterior tongue base backward and who could not elevate their pharyngeal during swallowing
* severe swallowing disorder or aspirate defined by videofluorography
* other malignances, neurovascular disease, demyelinating disease
* cancer relapse or metastases
The Efficacy of Tranexamic Acid in Preventing Postpartum Haemorrhage After Caesarean Section

This study seeks to determine if the using tranexamic acid prophylactically at caesarean section will prevent postpartum haemorrhage which is a major cause of maternal mortality in Zimbabwe and globally.

This trial will be an placebo-controlled, two-centre, randomized control trial with two parallel groups including 1,162 women who undergo elective or emergency caesarean deliveries at term. The study group will receive tranexamic acid (TXA) 1g intravenously at the onset of skin incision. There is normal saline placebo for the control group. The study and control groups will both receive the standard care offered at caesarean section including 5 IU of oxytocin intravenously on delivery of the baby. .

Eligibility Criteria:
Inclusion Criteria: Women undergoing elective or emergency caesarean section with:

* Estimated gestational age of 37 weeks or more
* Live intrauterine foetus
* Elective or emergency caesarean delivery
* Signed informed consent

Exclusion Criteria:

* History of coagulopathies or conditions predisposing them to thromboembolic phenomena,
* seizure history,
* autoimmune disease,
* placental abruption,
* placenta praevia,
* abnormally adherent placentae if identified on prenatal ultrasound,
* eclampsia or HELLP syndrome,
* known hypersensitivity to TXA,
* planned general anaesthesia,
* caesarean delivery for the second twin or second/third triplet(s) after vaginal birth of the first twin,
* poor understanding of English/Shona languages,
* those who have received anticoagulants in the week before delivery
* persons-under-investigation for Coronavirus disease (COVID-19) and confirmed COVID-19 positive women
Assessment of a Properly Video Stylet Angulation for Orotracheal Intubation

Uses the video stylet with different angulation to assist the orotracheal tube passing the oral cavity, oropharynx and advanced into the trachea

In the patients receiving general anesthesia with nasotracheal or orotracheal intubation is common. However, a orotracheal tube blindly passing through the oral cavity and oropharynx may easily result in oral cavity and oropharynx damages.

The advancement of the tube from oropharynx into trachea may assist using the video stylet.

The aim of the study is to investigate use which angulation including 45 degree, 70 degree and 90 degree is appropriate to assist the orotracheal tube passing the oral cavity, oropharynx, and advanced into the trachea.

Patients are randomized into three groups by 45 degree, 70 degree and 90 degree to facilitate orotracheal tube sliding through into trachea and compared with each other group. Hemodynamic changes in each time interval, each time taken of tube going through the oral cavity, tube advanced from oropharynx into trachea will be recorded.

The incidence of using the video stylet with different angulation to accurately place tube tip into trachea, intubation related side effects and complications are recorded at postoperative time stages.

Eligibility Criteria:
Inclusion Criteria:

* undergoing surgery with general anesthesia(GA)
* ASA(American Society of Anesthesiologists):Ι to III
* 20 to 65 years old
* mouth Open \> 3 cm
* the systemic disease exclusion
* conscious clear and without major Neurocognitive Disorder
* Mandarin or Taiwanese speaker
* agree the purpose of the study and sign the ICF

Exclusion Criteria:

* difficult airway assessment \[limited mouth opening \< 3cm, limited neck motion(thyromental distance \< 6cm)\]
* previous head neck surgery history, oral and respiratory tract tumors, oral infections, neck disease, loosen tooth
* morbid obesity
* reject to participate
FOLFIRI Versus Irinotecan as Second-line Treatment in Metastatic Colorectal Cancer Patients

This study is designed to compare the efficacy and safety of FOLFIRI regimen with irinotecan monodrug in the treatment of advanced colorectal cancer patients in the second-line setting.


Eligibility Criteria:
Inclusion Criteria:

* aged 18-70 years with histologically or cytologically confirmed advanced colorectal adenocarcinoma
* Eastern Cooperative Oncology Group performance status of 0 to 2
* life expectancy of ≥ 3 months
* patients who had failed first-line treatment with either XELOX (capecitabine combined with oxaliplatin) or FOLFOX (5-fluorouracil/leucovorin with oxaliplatin)
* at least one measurable disease lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) criteria
* have adequate bone marrow, hepatic, and renal function

Exclusion Criteria:

* patients with previous chronic inflammatory bowel disease, chronic diarrhea or recurrent bowel obstruction
* patients with symptomatic brain metastases
* active clinical severe infection
* previously received irinotecan
* dihydropyrimidine dehydrogenase (DPD) enzyme adequate
Mannose Binding Lectin Gene Polymorphism Versus Microbial Virulence in the Pathogenesis of Vulvovaginal Candidiasis

The vaginal mucosa is inhabited by both fungal and bacterial microorganisms which normally co-exist with the host in a tightly regulated and commensal manner.

Nevertheless, under certain circumstances, this co-existence can turn into a pathologic state followed by symptomatic disease

Eligibility Criteria:
Inclusion Criteria:

* 1. Married females in the reproductive age period. 2. Females complaining of vaginal discharge (whitish and scanty), itching, dyspareunia, pruritis, and signs of vulvovaginitis ie. erythema.

Exclusion Criteria:

* females who attended the same clinic in the same period, matched the cases regarding the age group, without having Candida infection as confirmed by culture of vaginal swabs.
Effectiveness of the Consent Process

The purpose of this study is to evaluate the effectiveness of the consent process currently used for outpatient endoscopy procedures at our hospital. Results from this study will be used to assist in making improvements in the way we communicate with parents, thereby enhancing the ability to provide informed consents.

Obtaining informed consent before performing an invasive medical procedure or treatment is a crucial component of patient care. The manner in which the consent process is conducted impacts the doctor/patient relationship, patient safety and patient satisfaction. Many times, patients sign consent forms without reading or understanding them. Although the form has been signed, true informed consent has not been obtained. While there are many variables that impact the ability to truly consent, ineffective communication between the patient and health care providers hampers the process.

Evidence shows that improving the consent process by ensuring effective communication between the child's parent and health care team affords substantial benefit. A consent process well done strengthens the parent-provider relationship. It positively impacts risk management. It improves patient safety. It diffuses would-be litigants by helping parents have realistic expectations of care. The consent process should allow and encourage parents to exercise both their right and their responsibility to take an active role in their child's health care.

Eligibility Criteria:
Inclusion Criteria:

* Adult parent or legally authorized representative (LAR) of child who has consented to undergo an out-patient endoscopy at CMHC as a diagnostic procedure
* Ability to converse in English
* Provided implied consent prior to data collection and verbal consent after data collection to participate in this research study

Exclusion Criteria:

* Any parent/ LAR under the age of 18 years
* Time constraint or verbally stating they do not wish to provide study data prior to child undergoing endoscopy
* Stating they do not wish to have these data used as study data after completion of the interview
Cognitive Therapy for Urinary Dysfunction in Parkinson´s Disease

Idiopathic Parkinson's syndrome (IPS) is one of the most common neurodegenerative diseases. The prevalence and significance of this disease is continuously increasing in the course of demographic change. For many decades, the focus of diagnostics and therapy was on the motor symptoms of IPS. Only in recent years, it has been recognized that Parkinson's patients also suffer from a variety of non-motor symptoms. These have a decisive influence on the patient's quality of life. As one of the most common non-motor symptoms, 55 to 80% of IPS patients suffer from urinary dysfunction. This is associated with a very high impairment of quality of life due to a high degree of stigmatization and impairment of social participation. In clinical everyday life, Parkinson's patients regularly report the occurrence of a strong imperative urge to urinate, which occurs suddenly and is usually triggered by a certain external stimuli. Specific cognitive processing and reflection of these external stimuli seems to help overcome the imperative urge to urinate. From this clinical observation, it can be assumed that the imperative urge to urinate is subject to a certain cognitive control in the sense of targeted inhibition.

The pharmacological therapy of urinary dysfunction in IPS patients is severely restricted and characterized by insufficient proof of efficacy as well as a high potential for side effects. In clinical practice, alpha-blockers and anticholinergics are frequently used, but the evidence base for IPS is inadequate. In addition, there is a highly relevant risk for Parkinson's patients of specific side effects such as orthostatic dysregulation or deterioration of cognition up to psychoses and hallucinations. This greatly limits their use especially in older IPS patients. While the use of dopaminergic medication is essential for the treatment of motor symptoms in Parkinson's patients, a large number of studies have not confirmed sufficient evidence for the efficacy of dopaminergic medication in urinary dysfunction. In addition, non-pharmacological therapy options, in particular pelvic floor training, are used to treat bladder dysfunction. Due to the lack of risk of side effects, pelvic floor training is currently recommended as a first-line therapy option for IPS patients. Initial studies have shown positive effects, but due to the lack of randomized controlled trials, a sufficient evidence base for this has not yet been established.

The aim of the study is to examine whether a purely cognitive therapy approach is suitable to improve subjective and objective symptoms of urinary dysfunction in IPS patients. This therapeutic approach will be compared with the gold standard of pelvic floor training in terms of efficacy.


Eligibility Criteria:
Inclusion Criteria:

* consenting capacity (MOCA \>17) and written consent
* idiopathic parkinson syndrome according to UK Brain Bank criteria
* female gender

Exclusion Criteria:

* missing consenting capacity (MOCA \<18)
* current depressive episode (BDI \> 18)
* current intake of medication for the treatment of bladder dysfunction
The Value of Central Venous-arterial Carbon Dioxide Difference

By observing the changes of Central venous-arterial partial pressure difference of carbon dioxide \[P (v-a) CO2\] in liquid resuscitation during early escharectomy in patients with large-scale burns, We investigate the effect of P (v-a) CO2 on postoperative tissue perfusion and oxygenation in order to seek a more effective intergrated target plan of liquid resuscitation for burn patients.

Objective: By observing the changes of Central venous-arterial partial pressure difference of carbon dioxide \[P (v-a) CO2\] in liquid resuscitation during early escharectomy in patients with large-scale burns, We investigate the effect of P (v-a) CO2 on postoperative tissue perfusion and oxygenation in order to seek a more effective intergrated target plan of liquid resuscitation for burn patients.

Methods: a prospective observational study was conducted on 145 patients with extensive burns admitted to surgical intensive care unit（SICU）of Guangzhou Red Cross hospital from January 2016 to December 2019. All patients received hemodynamic monitoring and goal-directed fluid therapy, patients with central venous oxygen saturation (ScvO2)\< 70% were excluded. Patients were divided into the following groups according to the changing trend of Pcv-aCO2 between T base (before induction) and T 0h (after surgery) : group 1 (H-H) : Pcv-aCO2≥6mmHg between T base and T 0h. Group 2 (L-H) : Pcv-aco2\< 6mmHg at T base and≥6mmHg at T 0h; Group 3 (H-L) : Pcv-aCO2≥6mmHg at T base and \< 6mmHg at T 0h. Group 4( L-L) : Pcv-aCO2 \< 6mmHg between T base and T0h.Postoperative basic physiological indicators such as heart rate（HR）, blood pressure, central venous pressure (CVP), cardiac output index (CI), Pcv-aCO2 and lactic acid were recorded at 0 and 18 hours after surgery. Oxygen dynamic indicators such as oxygen delivery index (DO2I), oxygen consumption index (VO2I), oxygen uptake rate (O2ER) and so on were calculated. Pearson correlation analysis was used to evaluate the correlation between Pcv-aCO2 and CI. The change of tissue perfusion and oxygenation with different levels of Pcv-aCO2 after fluid resuscitation were analyzed.

Eligibility Criteria:
Inclusion Criteria:

1. ASAI-II
2. New York Heart Association classification of cardiac function I-II
3. Estimated time of operation\<3h
4. The circulatory system of patients is stable after thrapy：CVP8～12 mmHg；MAP≥65 mmHg；urine volume\>0.5m1/kg/ h；ScvO2：≥70％。

Exclusion Criteria:

1. Anesthetic drug allergy or contraindication
2. Patients with cardiopulmonary system disease、cardiopulmonary function abnormality、severe inhalation injuryand severe visceral injury.
Intermittent Cold Blood vs Crystalloid Cardioplegia in Aortic Valve Surgery

Controversies still exists concerning the overall clinical effects of blood-based vs. crystalloid- based cardioplegic solution for myocardial protection during cardiac arrest. Both techniques are used world-wide. No larger prospectively randomized studies comparing the two methods have been reported. The aim of this study is to collect a large number of clinical data to create a proper basis for evaluation of the two techniques.

All patients admitted for aortic valve replacement with or without concomitant CABG and operated by E.Ø. or G.T. are included in the study. All preoperative, operative and postoperative data are prospectively recorded, focusing on clinical outcome parameters

Eligibility Criteria:
Aortic valve replacement
Lubricating Eye Drops After Routine Cataract Surgery

Patient satisfaction and dry symptoms in patients undergoing routine uncomplicated cataract surgery in NHS patients treated with prophylactic phosphate-free, preservative-free lubricant eye drops (0.3% cross linked sodium hyaluronate, AEONTM Protect Plus and0.15% Sodium Hyalu-ronate with vitamins A and E, AEONTM Repair): A randomized, prospective, controlled study.

The aim of this study is to investigate the routine use of such lubricating drops in a randomized, prospective methodology in patients undergoing uncomplicated cataract surgery in the NHS setting. As these drops are provided with the intraocular lens, if found to be of benefit in reducing dry eye problems such a study might provide evidence for the universal implementa-tion of post-operative ocular lubricant drops

Eligibility Criteria:
Inclusion Criteria:

1. Bilateral or unilateral cataracts requiring surgical intervention
2. Age over 18 years
3. Able to understand informed consent and the objectives of the trial
4. Not pregnant, not breast feeding
5. No previous eye surgery

Exclusion Criteria:

1. age-related macula degeneration
2. glaucoma
3. previous retinal vascular disorders
4. previous retinal detachment or tear
5. any neuro-ophthalmological condition
6. any inherited retinal disorder or pathology
7. previous strabismus surgery or record of amblyopia
8. previous TIA, CVA or other vaso-occlusive disease
9. already enrolled in another study
10. already on prescribed lubricating drops
COMMIT HIV Trial Nepal

Community Healthcare Workers (CHWs), who live in the communities they serve, have the potential to reach patients who poorly engage in their care. Motivational Interviewing (MI) is a special type of interactional approach that focuses on improving the person's motivation to engage in healthy behaviors, such as keeping their clinic appointments and regularly taking medications. In this study, we will develop a mobile health tool that will assist CHWs in two tasks while they utilize MI to assist patients' engagement in care: 1) follow prompts on the mobile device to deliver MI; and 2) record consented conversations between CHWs and patients so that MI specialists can review the audiotape and provide feedback to maintain the MI skills.


Eligibility Criteria:
Inclusion Criteria:

1. Inclusion criteria for patient population: 1) having a documented HIV diagnosis, 2) living in the community health worker catchment area at the Nepal research site and , 3) having poor adherence (missed a clinic visit by more than 2 weeks, \<95% adherence from visual analogue scale and/ or failed to refill their antiretroviral medications 1 week past the expected date)
2. Inclusion criteria for community health worker or a community health worker supervisor: living/working at the Nepal research site who has received motivational interviewing training as part of the intervention, and are involved directly in program implementation process.

Exclusion Criteria:

1. Exclusion criteria for patient population: includes decision from the patient to not receive care delivered by care provider at the Nepal research site or not to participate in the study
2. Exclusion criteria for a community health worker or a community health worker supervisor: includes decision not to participate in the study.
Drug-Drug Interaction Study Between EDP-938, Cyclosporine and Prednisone in Healthy Adult Subjects

A Non-Randomized, Open-Label, Two-Part, Drug-Drug Interaction Study to Evaluate the Effects of Cyclosporine and Prednisone on the Pharmacokinetics and Safety of EDP-938 in Healthy Adult Subjects


Eligibility Criteria:
Inclusion Criteria:

* An informed consent document signed and dated by the subject.
* Healthy male and female subjects of any ethnic origin between the ages of 18 and 55 years, inclusive.
* Screening body mass index (BMI) of 18 to 30 kg/m2 with a minimum body weight of 50 kg
* Female subjects of childbearing potential must agree to use two effective methods of contraception from the date of Screening until 90 days after the last dose of EDP 938.

Exclusion Criteria:

* Clinically relevant evidence or history of illness or disease.
* Pregnant or nursing females.
* History of febrile illness within 7 days prior to the first dose of study drug or subjects with evidence of active infection.
* A positive urine drug screen at screening or Day -1.
* Current tobacco smokers or use of tobacco within 3 months prior to screening.
* Any condition possibly affecting drug absorption (e.g., gastrectomy, cholecystectomy).
* History of regular alcohol consumption.
* Participation in a clinical trial within 30 days prior to the first dose of study drug.