cyrilzakka/clinical-trials huggingface dataset:
Retrospective Analysis of Surgical Outcomes After Corneal Transplantation

Currently, no demographic and surgical results comparing different donor cornea sources were available in Taiwan. National Taiwan University Hospital (NTUH), as one of the largest tertiary medical centers in northern Taiwan, is now in charge of a big part of intense care for patients receiving corneal transplantation. With detailed medical record done of these patients during care in the ward and out-patient clinic, the investigators are competence for this meaningful program.

An insufficient donor supply is a worldwide problem in organ transplantation. Even with corneal transplantations, the most widely performed transplantation, shortages and imbalances in donor supply is a global concern. In National Taiwan University Hospital (NTUH), the investigators performed over one hundred of corneal transplantations every year and the majority of donor corneas were from the eye bank in United States. Previous literature showed satisfactory results in corneal transplantation using foreign donor corneas compared with domestic corneas. However longer preservation time had associated with a statistically significant increased risk of persistence of the postoperative epithelial defect. On the other hand, longer storage times may allow better outcomes in high-risk grafts because of the depletion of donor T cells from the donor cornea into the storage media.

Currently, no demographic and surgical results comparing different donor cornea sources were available in Taiwan. NTUH, as one of the largest tertiary medical centers in northern Taiwan, is now in charge of a big part of intense care for patients receiving corneal transplantation. With detailed medical record done of these patients during care in the ward and out-patient clinic, the investigators are competence for this meaningful program.

Eligibility Criteria:
Inclusion Criteria:

* The patients who received corneal transplantation within full chart records

Exclusion Criteria:

* The patients have cognitive Impairment.
* No detail or unclear ophthalmologic record.
* Patients or their legal representative have no willing to accept this tracing study.
A Pilot Study Assessing the Effect of Lymphaticovenous Micro-Anastomosis in the Treatment of Postmastectomy Lymphedema

This study will assess the impact of lymphaticovenous microanastomosis in volume reduction of postmastectomy upper extremity lymphedema. We hypothesize that multiple lymphaticovenous micro-anastomosis in the distal arm will result in the reduction of volume and improvement in quality of life of patients with post-mastectomy lymphedema


Eligibility Criteria:
Inclusion Criteria:

* Subject is 18-70 years of age
* Subject is Stage II-IV unilateral lymphedema

Exclusion Criteria:

* Subject is less than 6 months from completion of cancer treatment
* Subject has allergic reaction to the lymphatic contrast agent (Indocyanine Blue)
* Subject is medically unfit for the procedure
* Subject is unable to complete the follow-up visits
* Women with a positive urine pregnancy test are excluded from this study; women of childbearing potential (defined as those who have not undergone a hysterectomy or who have not been postmenopausal for at least 24 consecutive months) must agree to refrain from breast feeding and practice adequate contraception as specified in the informed consent. Adequate contraception consists of oral contraceptive, implantable contraceptives, injectable contraceptives, a double barrier method, or abstinence.
* Subject has bilateral lymphedema
Determination of Residual Anticoagulatory Effects of Fondaparinux

The purpose of this study is to determine residual anticoagulatory effects of a prophylactic or therapeutic fondaparinux treatment i.e. prior to surgery/intervention, after pause of therapy etc.


Eligibility Criteria:
Inclusion Criteria:

* Fondaparinux therapy for at least 3 days

Exclusion Criteria:

* Age \< 18 years
* Hemodialysis
HCV-RNA Kinetics During Sorafenib for Hepatocellular Carcinoma (HCC)

This research study is a Phase IV clinical trial. Phase IV trials are used to further test and monitor the safety of a drug approved by the FDA and to see if the drug has any other indications that can be used to treat different diseases.

Sorafenib is a new drug, which is approved under the brand name Nexavar for the treatment of liver cancer. It is also currently being tested in various other cancers. Sorafenib works by slowing down and/or stopping the development of new cancer cells and new blood vessels. By slowing down and/or stopping the growth of new blood vessels around a tumor, it is believed that sorafenib prevents or slows down the growth of tumors.

The researchers of this study would like to study the effects of sorafenib on hepatitis C by drawing additional research blood samples from people infected with hepatitis C who are receiving sorafenib treatment for liver cancer. These tests will measure certain proteins in the blood (HCV-RNA) which may indicate if sorafenib has any effect on the hepatitis C virus.

This is a prospective, open-label, non-interventional trial to evaluate HCV-RNA levels during treatment with Sorafenib in patients with advanced hepatocellular carcinoma.

Participants will receive Sorafenib 400mg orally twice daily. HCV-RNA (Hepatitis C Virus - Ribonucleic Acid) levels will be measured at baseline, week 2 of sorafenib, week 4 of sorafenib, week 6 of sorafenib, week 8 of sorafenib, week 12 of sorafenib, and 2 weeks after discontinuing sorafenib. HCV-RNA levels will be measured by drawing about 2 tablespoons of blood

During the study period, tumor assessments will be done by MRI (magnetic resonance imaging) or CT (computed tomography) scans at baseline and every 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Histologically and/or radiologically confirmed advanced HCC
* Detectable HCV RNA with anti-HCV-positivity
* Life expectancy of at least 3 months
* Willing to use adequate contraception

Exclusion Criteria:

* Pregnant or breastfeeding
* Undetectable HCV RNA
* Uncontrolled hypertension
* Active or clinically significant cardiac disease
* Thrombolic, embolic, venous or arterial events within 6 months of informed consent
* Pulmonary hemorrhage/bleeding event (NCI-CTCAE grade 2 or higher) within 4 weeks before study entry
* Previously untreated or concurrent cancer except cervical cancer in situ, treated basal cell carcinoma or superficial bladder tumor
* Presence of non-healing wound, ulcer or bone fracture
* History of organ allograft
* Known or suspected allergy or hypersensitivity to any of the study drugs
* Any malabsorption condition
* Inability to comply with the protocol and/or not willing or not available for follow up
* Major surgery within 30 days prior to start of study drug
A Dose-finding Study of RO5323441 in Patients With Metastatic Treatment-Refractory Colorectal or Ovarian Cancer

This exploratory, open label study will assess the the dose-effect relationship, efficacy and safety of RO5323441 in patients with metastatic treatment-refractory colorectal or ovarian cancer. Cohorts of patients will receive doses of intravenous RO5323441 in the range of 25mg to 3g every 1 or 2 weeks and will undergo serial dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) assessments. In the absence of disease progression and unacceptable toxicity, patients may continue to receive their maximum dose of RO5323441 for a core treatment phase of up to a total of 6 months. Treatment with RO5323441 can be extended at the investigator's discretion until disease progression or unacceptable toxicity occurs. Target sample size is \<100.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, \>/=19 years of age
* metastatic or unresectable colorectal or ovarian cancer refractory to, or unsuitable for standard therapy
* presence of tumor lesions suitable for DCE-MRI evaluation
* WHO performance status 0-1
* adequate bone marrow, liver and renal function

Exclusion Criteria:

* patient unsuitable for MRI scanning (e.g. metal implants, pacemaker, claustrophobia, hypersensitivity to DCE-MRI contrast material)
* brain metastases
* clinically significant ascites
* active bleeding, bleeding diathesis, oral anti-vitamin K medication (other than low dose coumarin) or history of coagulation disorders
* radiation therapy within 3 weeks, or anti-neoplastic therapy \<30 days prior to first dose of study drug
* chronic therapy with systemic steroids or another immunosuppressive agent \<2 weeks prior to first dose of study drug
* treated with bevacizumab in last regimen of systemic therapy
Periodontal Ligament Stem Cell Implantation in the Treatment of Periodontitis

Cell sheet technique possess the properties of conserving the ECM, rich molecules and retaining cell vitality, and will promote the capacity of cell adhesion and proliferation. The stem cell based cell sheet therapy has been utilized in many fields and scored the satisfactory results. Periodontitis is a chronic disease which causes the destruction of the periodontal tissue and leads to the teeth loss in the end. The routine cell-based therapy to the periodontitis was confronted with many difficulties. In the investigators previous preclinical research, +the investigators fabricated periodontal ligament stem cell (PDLSC) pellets and cell sheet fragment and applied them in the periodontal defect area for tissue regeneration and periodontitis treatment. And the investigators carried out a comprehensive study of the PDLSC allograft. The host responses and implanted cell fates were recorded. After the scientific investigation of the preclinical study, the investigators designed the preliminary clinical trial of PDLSC cell sheet for the chronic periodontitis therapy in the aims to test the PDLSC fates and explore one ideal transplantation mode.

our protocol mainly includes following steps:

1. select periodontitis patients :all patients were given the comprehensive examination on the oral condition including clinical examination, radiological evaluation and the immune system tests
2. select healthy donor teeth for PDLSC isolation and expansion.
3. fabricate the cell sheet and prepare the PDLSC cell sheet pellets and cell sheet fragment.
4. patients given the routine mechanical and chemical treatment for 4 weeks were randomized divided into 4 groups according to the visit time: i) the cell sheet fragment plus bio-ss transplantation; ii) the cell sheet pellets plus bioss transplantation; iii) the bio-ss transplantation and iv) the control.
5. all the operations were carried out as the routine GBR procedures.
6. the clinical, radiological examination and the changes of the immune system at the point of 1 day before and 4weeks, 12weeks, 24weeks and one year after the intervention were recorded and compared.

Eligibility Criteria:
Inclusion Criteria:

1. adult chronic periodontitis
2. pathological lesion is stable after the routine mechanical and chemical treatment.
3. the local pathological lesion has the subbony defect
4. the oral heath was kept approved.
5. there are more 2 teeth with the continued lesion

Exclusion Criteria:

1. the age\>50 year or \< 40year
2. the patient has the genetic background of the periodontitis.
3. the bone destruction was larger than 2/3 of the root length.
4. the preclinical treatment was stable.
5. the severe systematic diseases.
6. the patients who can not cooperate with the whole the observation.
ClassIntra® for Better Outcomes in Surgery - CIBOSurg

Intra- and postoperative adverse events (iAEs and pAEs) occur in up to one third of all patients undergoing surgery. They are devastating to patients and costly to health care systems. Their number tends to increase due to the rising complexity of both the patient's risk profile and the surgical procedure. Postoperative deaths have been identified to be the third most frequent cause of death worldwide. Teamwork in surgery has been attributed to have a potentially great impact on avoiding postoperative morbidity. Up to 50% of all adverse in-hospital events were rated to be potentially preventable. However, their prevention typically requires a change in systems and individual behaviour. Standardised assessments of iAEs and pAEs are a prerequisite to develop and define strategies for prevention of AEs. While awareness of pAEs has highly risen through the introduction of the Clavien-Dindo classification, the most widely used classification for grading severity of pAEs, the relevance of transparent monitoring of iAEs is still highly undervalued.


Eligibility Criteria:
Inclusion Criteria:

- All in-hospital patients (consecutive or random sample) undergoing surgery from general surgery, vascular, surgery, orthopaedics/traumatology and urology in the operating room with anaesthesia involvement

Exclusion Criteria:

* Patients undergoing one-day-surgery (with or without anaesthesia-involvement)
* Procedures without anaesthesia-involvement (in- or out-patient)
* ASA risk classification (ASA) VI patients (brain-death, organ-donor)
* Follow-up procedure of a patient already included in the study
Comparison of Outcomes Between Open Wedge High Tibial Osteotomy and Double Level Osteotomy in Antromedial Knee Arthritis With Extra Articular Deformity

To compare the radiographic and clinical outcomes of varus osteoarthritic knees treated with an open-wedge high tibial osteotomy (OWHTO) alone or with a double-level osteotomy (DLO). It was hypothesized that treatment with DLO would prevent the joint line obliquity (JLO) , optimize post-operative limb alignment and provide better clinical and radiological outcomes after surgery than medial opening-wedge high tibial osteotomy (OWHTO) alone for patients with medial compartment osteoarthritis.

Osteoarthritis is a degenerative joint disease characterized by erosion of the articular cartilage, hypertrophy of the bone at the margins and subchondral sclerosis(1). Osteoarthritis of the knee is a common problem causing significant knee pain and disability. Medial compartment osteoarthritis is predisposed to be varus deformity of the knee(2). High tibial osteotomy (HTO) is a well-established method for treatment of medial Uni compartmental-knee osteoarthritis and correction of varus deformity(3).Double level osteotomy recently used as another method for treatment this problem to improve outcomes and decrease complication(4).

Eligibility Criteria:
Inclusion Criteria:

* Patients that are indicated for surgery for medial compartment osteoarthritis only (medial joint line tenderness, varus tibiofemoral malalignment) with classification of Kellgren Lawrence grade (1/2/3)
* Age between 40 _ 60 years
* No associated bony fractures or deformities
* No associated ligamentous functional instability
* Varus more than or equal 15 degrees

Exclusion Criteria:

* Age younger than 40 or older than 60 years
* Secondary Arthritis (Inflammatory arthritis, post-traumatic osteoarthritis, active knee infection)
* Lateral Compartment OA or patellofemoral OA
Pre- and Postoperative Probiotics Administration in Patients Undergoing Sleeve Gastrectomy

Patients will be randomized into 2 groups:

* G1: Patients undergoing sleeve gastrectomy as bariatric procedure and receiving pre- and postoperative probiotics
* G2: Patients undergoing sleeve gastrectomy as bariatric procedure and not receiving pre- or postoperative probiotics

Weight loss will be assessed 1 year after surgery

Patients will be randomized into 2 groups:

* G1: Patients undergoing sleeve gastrectomy as bariatric procedure and receiving pre- and postoperative probiotics
* G2: Patients undergoing sleeve gastrectomy as bariatric procedure and not receiving pre- or postoperative probiotics

Preoperative probiotics scheme include:

* saccharomyces boulardii ntc 5375 + enterococcus faecium UBEF-41 + lactobacillus acidophilus LA 14 during 15 days (between 6th and 4th weeks before surgery)
* Bifidobacterium lactis BL 04 + Bifidobacterium breve BB 03 + Bifidobacterium bifidum BB 06 + Bifidobacterium longum BL 05 during 15 days (between 4th and 2nd weeks before surgery)
* lactobacillus rhamnosus LR 32 + lactobacillus rhamnosus HN001 + lactobacillus acidophillus LA 14 during 15 days (between 2nd week and the day before surgery)

Postoperative probiotics scheme include:

* saccharomyces boulardii ntc 5375 + enterococcus faecium UBEF-41 + lactobacillus acidophilus LA 14 during 15 days (between 1st and 3rd weeks after surgery)
* Lactobacillus rhamnosus LR 32 + Bifidobacterium lactis BL 04 + Bifidobacterium longum BL 05 + lactobacillus salivarius LS 33 + lactobacillus acidophilus LA 14 + bifidobacterium bifidum BGN 4 during 4 months (between 4th and 20th weeks after surgery.

Both groups will receive the same nutritional recommendations.

1 year after surgery, weight los will be assessed as primary outcome. Secondary outcomes will include daibetes mellitus remission and dyslipidemia remission.

Weight loss will be assessed 1 year after surgery

Eligibility Criteria:
Inclusion Criteria:

* BMI \>40
* BMI \>35 associated to diabetes mellitus, hypertension, dyslipidemia or sleep apnea/hypopnea síndrome
* Patients undergoing laparoscopic sleeve gastrectomy as primary bariatric procedure

Exclusion Criteria:

* Revisional surgery
* Patients with gastroesophageal reflux disease
* Patients planned for a sleeve gastrectomy as first step of a second malabsorptive procedure
* Patients with immune deficiencies or with chronic intake of immune supressor drugs
* patients refusing to participate in the study
Glycemic Index of Cacao Fruit Pulp in Healthy, Human Subjects

Cacao fruit pulp is a sweet and fruity carbohydrate-rich edible mucilage that is often discarded. The objective of this study is to assess the glycemic response and determine the glycemic index of cacao fruit pulp.

In an acute, open-labeled, randomized design, individuals without diabetes were studied over 120 minutes after consuming 25 grams of available carbohydrate portions of cacao pulp or dextrose.

Eligibility Criteria:
Inclusion Criteria: Subjects were males or non-pregnant females and in good health.

Exclusion Criteria: Subjects with a known history of AIDS, hepatitis, diabetes or a heart condition. Subjects taking medication or with any condition that might make participation dangerous to the subject, to others, or affect the results.
Education Interventions Model for Rational Drug Use (RDU)

The purpose of this study is to develop, implement and evaluate an economically viable and efficient interventions education model for rational drug use, adaptable to different pathological situations and should be implemented into Brazil Heath Care System.

Currently, the educational interventions regarding the use of medicines need to be expanded and more effective, and thus set themselves up in strategies for reorganization of dispensing drugs in health services and provide support to the population to obtain greater control over their health. The pharmacist, in turn, inserted in the multidisciplinary team has an important role in health education with the aim of improving knowledge about the disease and the various treatment options, reflecting positively on treatment adherence and clinical outcomes as a result and quality of life related to patient health. Thus, health education, to share knowledge, represents an important task and involves attentive listening to the community to identify their needs and then solve them. From this perspective, therefore, the educational means to educate health and an integral formation of individuals as social actors critics who understand and question the social relations, transforming subjects into citizens participating in the process of health education, helping to raise awareness , knowledge and understanding of living conditions and relationships with health, promoting quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Subject with asthma diagnosed according to criteria of the Global Strategy for Asthma Management and Prevention;
* Subject is a male or female with 18 to 73 years-old;
* Subject who has access to medications supplied by the the Brazil Heath Care System;
* Subject unable to perform the procedures or conditions such as pregnancy that may affect the results of the study;
* Literate subject without Cognitive Disorders, Alzheimer's, Dementia, that can limit the ability to participate in this study;
* Subject who have availability to attend the monthly meetings;
* Subject provides written informed consent and attend the first evaluation.

Exclusion Criteria:

* Subject who cannot be classified in the inclusion criteria.
External Shoe Lift to Improve Healing and Adherence in Patients With Diabetic Foot Ulcers

Previous researches hipothesize that imposed limb-length discrepancies may discourage adherence in patients with active diabetic foot ulcer and using offloading devices. Our hipothesis is that the use of an external shoe lift contralaterally to the affected foot may improve adherence to offloading devices and improve healing.


Eligibility Criteria:
Inclusion Criteria:

* Plantar diabetic foot ulcer.
* Wagner I and II classification.
* Ulcer area between 1-30 cm square centimeters.
* HbA1c values in the last three months below 11%
* Ankle brachial Index (ABI) value \> 0.5.

Exclusion Criteria:

* Diagnosis of Critical Limb Ischaemia definid by TASCC II guideline.
* Presence of foot ulcer in both feet.
* Presence of soft tissue infection.
* Osteomyelitis suspicion.
* Peripheral neuropathy due to different causes than diabetes.
Phage Therapy for the Treatment of Urinary Tract Infection

This is a single-patient, phase I/II clinical trial that aims to evaluate the potential of bacteriophage therapy to treat and prevent the recurrence of a drug-resistant urinary tract infection with serious long-term effects. This study will follow a minimally invasive phage therapy approach consisting of oral, topical (opening of the urethra) and bladder installations of a 3-phage cocktail comprised of HP3, HP3.1 and ES19.

This is a single-patient, phase I/II clinical trial that aims to evaluate the potential of bacteriophage therapy to treat and prevent the recurrence of a drug-resistant urinary tract infection. This study will follow a minimally invasive phage therapy approach consisting of oral, topical and bladder installations of a 3-phage cocktail comprised of HP3, HP3.1 and ES19.

Oral and bladder installation of bacteriophages will be administered on day 1 - and potentially day 7 depending on day 5 urine and stool lab results - and a topical preparation will be applied externally to the urethra for 30-minutes on days 1 to 3. However, if the participant is still experiencing mild symptoms on day 5, systemic antibiotics will be administered in combination with phage therapy.

The primary objective is to determine the safety and tolerability of minimally invasive bacteriophage therapy for treating recurrent urinary tract infections with severe long-term effects.

The secondary objective is to evaluate the 90-day clinical and microbial response to the minimally invasive administration of bacteriophages for recurrent urinary tract infections with severe long-term outcomes.

The total duration of participant involvement is 2 years, while the study is estimated to be completed in 3 years.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of recurrent chronic urinary tract infections with severe long term effects
* Can speak and understand English
* Willing to follow the protocol

Exclusion Criteria:

* Stage 5 chronic kidney disease
* Abnormal liver function tests
* A urinary stent or chronic indwelling catheterization
* A known allergy to phage products
* Fever
* Pregnancy
* Involved in another clinical trial
Suggamadex and Fast-track Cardiac Anesthesia in a Developing Country

The purpose of this study is to retrospectively review our preliminary experience during a surgical trip to Tuxtla, Mexico, using suggamadex to reverse neuromuscular blockade following CPB and cardiac surgery for repair of CHD in infants and children.


Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent cardiac surgery and cardiopulmonary bypass in Tuxtla, Mexico in September 2015.

Exclusion Criteria:

* None