cyrilzakka/clinical-trials huggingface dataset:
10 Year Outcome of Total Knee Replacement (TKR) Using Sigma Prosthesis

The purpose of this study is to obtain a prospective database which will allow analysis of total knee outcomes.

A prospective database was set up in October 1998. Patient details are collected pre-operatively, intra-operatively and immediately post operatively. Patients are then followed up in a dedicated knee clinic at 6 months, 18 months, 3 years and 5 years. Data such as SF12 and the American knee society score has been done at each visit.

Eligibility Criteria:
Inclusion Criteria:

All patients undergoing total knee replacement in Fife
The Impact of Salpingectomy and Single Dose Systemic Methotrexate Treatments on Ovarian Reserve in Ectopic Pregnancy

The investigators aimed to investigate the effects of salpingectomy and Methotrexate administration on ovarian reserve in ectopic pregnancy.

In this study, the effects of unilateral laparoscopic salpingectomy and single dose of systemic Methotrexate administration on ovarian reserve in patients diagnosed with ectopic pregnancy were investigated.

Eligibility Criteria:
Inclusion Criteria:

* ectopic pregnancy diagnosis

Exclusion Criteria:

* history of endometriosis, ovarian surgery, systemic chemotherapy, ART treatment.
* patients treated with multiple doses of methotrexate or different surgical procedure (salpingostomy, milking)
Thalidomide/Dexamethasone Treatment And PET Evaluation In Organ Involvemenet of Cardiac Amyloidosis

To prove the organ-reversing potential of thalidomide for amyloidosis with cardiac involvement

Considering that dismal prognosis of amyloidosis is attributable to organ dysfunction, primary aim of amyloidosis treatment should be an organ reversal. However, due to various reasons, not much is known about organ reversal in amyloidosis. Almost all of the clinical trials evaluated hematologic response in amyloidosis. Meanwhile, besides autologous stem cell transplantation with high-dose melphalan conditioning, hematologic response rate of various agents such as bortezomib, melphalan, thalidomide and lenalidomide are similar for amyloidosis. However, organ reversing potential of these agents is not known. If there is a difference in organ reversing potential despite of similar hematologic response rate, drug with effective organ reversing potential should be a standard treatment for amyloidosis.

The investigators assume that thalidomide could make organ reversal in cardiac amyloidosis due to its specific mechanism of action. To prove this concept, the investigators propose a clinical trial that evaluates organ reversing potential of thalidomide in cardiac amyloidosis.

Eligibility Criteria:
Inclusion Criteria:

1. Age : more than 18 years old
2. Cardiac amyloidosis (both AL or AH type) patient who meet both (A and B) of the following criteria A. Cardiac involvement: meet one of the following criteria

   * Echocardiography: mean wall thickness \>12 mm, and no other cardiac cause
   * NTproBNP \>332 ng/l in the absence of renal failure
   * Evidence of cardiac amyloidosis in cardiac MRI B. Treatment history: No history of exposure to thalidomide
3. ECOG(Eastern Cooperative Oncology Group) performance status ≤ 3
4. Tolerable major organ function determined by laboratory examination i. Serum creatinine ≤ 3.0 mg/dl ii. Absolute neutrophil count ≥ 1000/μl iii. Platelet ≥ 75000/ μl iv. Hemoglobin ≥ 8.0 mg/dl v. Bilirubin \< 2 times or Alkaline phosphate \< 4 times upper limit of normal
5. Expected survival \> 3 months
6. Female participants of child-bearing potential must have a negative pregnancy test prior to treatment and agree to use dual methods of contraception for the duration of the study and for 30 days following completion of study. Male participants must also agree to use a barrier method of contraception for the duration of the study and for 30 days following completion of study if sexually active with a female of child-bearing potential.

Exclusion Criteria:

1. Amyloidosis without cardiac involvement
2. Patients who are planning to receive autologous stem cell transplantation
3. Patients who received autologous stem cell transplantation, remained in hematologic complete response
4. Pregnant, lactating or unwilling to use adequate contraception
5. Systemic infection unless specific anti-infective therapy is employed
6. Known allergies to thalidomide
7. Previous experimental agents or approved anti-tumor treatment within 1 months before the date of registration
(Bicalutamide) Casodex vs Placebo in Non-metastatic Early Prostate Cancer

The purpose of this trial is to study the effect of adjuvant or immediate hormonal therapy, versus placebo, in subjects who have either undergone a primary therapy (principally radical prostatectomy or radiotherapy) or who were otherwise to be managed by watchful waiting.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of non-metastatic cancer of the prostate gland
* Patient to be 18 years and above

Exclusion Criteria:

* Previous systemic therapy for prostate cancer
* Previous history of another form of cancer (not prostate) within 5 years of study start.
Clinical Evaluation of Genetron TERT PCR Kit in Glioma Patients

The purpose of this trail is to evaluate the performance of Genetron TERT PCR Kit in Glioma patients using real-time PCR method.

This trial follows the principle of synchronous blinding. The enrolled cases are coded, and the enrolled samples are detected with the Genetron TERT PCR Kit and Sanger sequencing method. The results were determined independently according to the cutoff values or interpretation requirements provided by each method.Combined with the results of clinicopathological classification, the incidence of C228T and C250T mutations of TERT promoter genes in different subtypes was counted to evaluate the clinical application performance of the Genetron TERT PCR Kit.

Eligibility Criteria:
Inclusion Criteria:

1. Enroll cases in strict accordance with the requirements of the study
2. The remaining samples after routine clinical testing
3. The collection and processing of samples meet the requirements of standard laboratory operations and product instructions
4. The relevant information of the sample is complete, including sample number, gender, age, and possible clinical diagnosis information
5. Each sample must have HE staining results (hematoxylin-eosin staining)
6. Pathological examination diagnosed as glioma, other brain tumors or normal tissues
7. Number of samples: 10 pieces of each sample with a thickness of 10μm, and the tumor content is not less than 50%

Exclusion Criteria:

1. The sample information is not complete
2. Severely contaminated samples
3. Samples that do not meet the requirements of sample collection and processing
Music Therapy in Pulmonary Rehabilitation

This study explores the effects of music therapy intervention on anxiety and time perception during pulmonary rehabilitation.

Background：

In recent years, in many domestic and foreign music therapy literature, it can be found that the intervention of music therapy can alleviate the anxiety of patients in the treatment, surgery, and even patients with critical care using ventilators, and then affect the patient's physiological indicators, in addition, there are also studies that mention that background music affects people's waiting time perception, reduces people's waiting time, can reduce the generation of negative emotions, and improve the quality of hospital medical care. The objective of this study was to explore the effects of music therapy on anxiety and time perception during pulmonary rehabilitation.

Study Design：

This case is a one-year single-center, prospective block randomizied trial.

Methods：

The study is expected to be 50 people, randomly assigned to two groups (control group, experimental group) will be carried out in the pulmonary rehabilitation room on the sixth floor of the Fu Jen Catholic University Hospital, using the Baker Anxiety Scale, physiological monitoring instruments and cardiac output monitor as tools to test the effects of anxiety sensations, physiological responses (heartbeat, breathing times, blood pressure, heart rate variability) and perceptual time in two situations of interventional music therapy and non-interventional music therapy during the rehabilitation of negative pressure respirators.

Effect：

It was mainly found that the intervention of music therapy can reduce anxiety, number of heartbeats, number of breaths and blood pressure, and shorten the perceptual time of patients with pulmonary rehabilitation.

Key words：

Music therapy; pulmonary rehabilitation; depression; percieved time; chronic obstructive pulmonary disease

Eligibility Criteria:
Inclusion Criteria:

* Recieved pulmonary rehabilitation at least three months
* Recieved a negative ventilation during a pulmonary rehabilitation
* A written informed consent

Exclusion Criteria:

* impaired of hearing
* decline to participate
* cognitive communication deficits
* acute exacerbation of copd within three months
Late Phase Acute Pancreatitis: a Tailored Step-up Approach

Several interventional and surgical procedures are available to treat moderate-to-critical acute pancreatitis (AP) in its late phase. The ongoing debate on these options, together with the scarcity of reported mid-term follow-up information in the Literature, prompted the investigators to conduct a review of our surgical experience, focused on those issues. The investigators reviewed retrospectively all the patients treated for moderate-to-critical AP according to Determinant-Based Classification (DBC), in the last nine years. Patients treated conservatively or operated within 4 weeks of the onset of the pancreatitis were excluded. All the included patients were managed following a "tailored" step-up approach, and divided into four groups, according to the first interventional procedure performed: percutaneous drainage (PD), endoscopic approach (END), internal derivation (INT), and necrosectomy (NE). In-hospital and mid-term follow-up variables, including a quality-of-life assessment, were analyzed and compared.

The following variables were evaluated: sex, age, severity of inflammation according to the DBC classification, PA etiology, CT scan severity index according to Balthazar criteria , clinical prognostic score using bedside index of severity of acute pancreatitis (BISAP) score.

Total length of hospitalization, operative management, necrosis cultures, total and post-interventional Intensive Unit Care (ICU) were also recorded and analyzed together with the in-hospital morbidity, mortality and re-admissions.

Patients were checked after discharge within 14 days and followed monthly as outpatients by gastroenterologists. A CT scan was performed within 4 months, or before in case of recurrent symptoms. During the follow-up, the English Standard Short Form 36 (SF-36) questionnaire was used to evaluate the general quality of life at three and six months, one and two years. The SF-36 examines 8 areas consisting of social and physical function, physical and emotional well-being, bodily pain, vitality, mental health and overall general health perception. At the six-month follow-up, the patients also completed a specific questionnaire about the pancreatic function. In particular, the total score takes in consideration abdominal pain using visual analogue pain score, diarrhea, unintentional weight loss, new onset of diabetes and use of enzyme supplementation. The score ranges between zero to five (all symptoms present). The work has been reported in line with the STROCSS criteria

Eligibility Criteria:
Inclusion Criteria:

* patients treated at our referral Center for moderate to critical AP, as classified by Determinant-Based Classification of Acute Pancreatitis Severity

Exclusion Criteria:

* patients who had undergone conservative treatment,
* patients who has been operated within 4 weeks (early phase)
Long-term Outcomes of Colonic Stent as a "Bridge to Surgery" for Malignant Large-bowel Obstruction

Study of long-term outcomes of colonic stent as a "bridge to surgery" for malignant large-bowel obstruction.

Prospective observational with retrospective analisis study of patients with left-sided malignant colonic obstruction undergoing stenting between April 2006 and April 2018 in Parc Tauli University Hospital. We assessed all patients with intent-to-treat and per protocol analyses in postoperative and long-term follow-up variables.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged over 18 years diagnosed with complete malignant colonic obstruction confirmed by CT.
* Elective surgery.
* Location in transverse, left or sigmoid colon.
* Patients who signed the informed consent documentation and agreed to undergo the procedure.

Exclusion Criteria:

* Benign pathology and palliative treatment.
* Unresectable lesion (intraoperative), severe ischemia or cecal perforation, fecal or advanced purulent peritonitis, emergency surgery.
* Previous chemotherapy.
Injured Submucosal Arteries After CSP for 10-19 Mm Nonpedunculated Colorectal Polyps.

Cold polypectomy has the advantages of simple operation, less time-consuming and fewer complications. Guidelines have recommended cold snare polypectomy (CSP) to resect small polyps sized \<9 mm. CSP was designed to improve the complete resection rate and reduce adverse events. Investigators hypothesize that CSP is better than conventional hot snare endoscopic mucosal resection (HS-EMR) in the presence of injured submucosal arteries detected in the submucosal layer for 10-19 mm nonpedunculated colorectal polyps, resulting in lower delayed bleeding after CSP of 10-19 mm nonpedunculated colorectal polyps.

Cold polypectomy has the advantages of simple operation, less time-consuming and fewer complications. Guidelines have recommended cold snare polypectomy (CSP) to resect small polyps sized \<9 mm. CSP was designed to improve the complete resection rate and reduce adverse events. Investigators hypothesize that CSP is better than conventional hot snare endoscopic mucosal resection (HS-EMR) in the presence of injured submucosal arteries detected in the submucosal layer for 10-19 mm nonpedunculated colorectal polyps, resulting in lower delayed bleeding after CS-EMR of 10-19 mm nonpedunculated colorectal polyps. The primary outcome measure was the presence of injured submucosal arteries detected in the submucosal layer. The secondary outcomes included immediate bleeding and the frequency of delayed bleeding requiring endoscopic treatment within 2 weeks after polypectomy. Immediate bleeding was defined as spurting or oozing which continued for more than 30 seconds.

Eligibility Criteria:
Inclusion Criteria:

* at least one polyp sized 10-19 mm (Paris classification Is or IIa) revealed by endoscopic examination.

Exclusion Criteria:

1. American Society of Anesthesiologists status class 3 or above
2. poor bowel preparation (Boston Bowel Preparation Scale \<6 points)
3. endoscopic features indicating submucous infiltration or malignancy
4. oral anticoagulants,or antiplatelet agents, or known blood coagulation disorders, or bleeding tendency
5. a history of colorectal resection
6. emergent colonoscopy (haemodynamic instability and/or continued active gastrointestinal bleeding and/or requiring intensive care patients)
7. inflammatory bowel disease, familial polyposis and colorectal cancer
8. pregnancy or lactation
9. severe cardiopulmonary dysfunction, cirrhosis, chronic kidney disease, other malignant tumours or severe infectious diseases.
Olfactory Change After Chemo-radiotherapy for Nasopharyngeal Carcinoma

This is an observational cohort study aimed to explore the changes of olfactory function at multiple time points from baseline to 1 year after radiotherapy among the local advanced nasopharyngeal carcinoma patients.

Newly-diagnosed patients with stage III or IV non-metastatic Nasopharyngeal Carcinoma (AJCC 8th) will be recruited. Olfactory function of consecutive patients with nasopharyngeal carcinoma was assessed prospectively before treatment and serially up to 1 year after radiotherapy by the Sniffin' Sticks olfactory function test and by The Questionnaire of Olfactory Disorders (QOD) as well as a patient symptom visual analogue scale. The change in olfactory function and it's influence factors in NPC patients who receiving induction chemotherapy with concurrent chemoradiotherapy will be investigated.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-70, regardless of sex.
* Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, type of WHO II or III, clinical stage III-IVa (according to the 8th American Joint Committee on Cancer \[AJCC\] edition).
* ECOG (Eastern Cooperative Oncology Group) score: 0-1.
* Patients receiving induction chemotherapy with concurrent chemoradiotherap.
* Patients must sign informed consent and be willing, and well understood the objective and procedure of this study.

Exclusion Criteria:

* Women in pregnancy or lactation.
* Patients who received additional treatment during the observation period due to disease progression.
* Patients with significantly lower heart, liver, lung, kidney and bone marrow function.
* Patient with severe medical condition.
* with a condition that could cause olfactory dysfunction, such as septum deviation, nasal polyposis, nasopharyngeal necrosis, congenital olfactory dysfunction, septum surgery, head trauma, chronic rhinosinusitis, allergic rhinitis, or psychiatric or neurological disorders, such as Parkinson's, MS and Alzheimer's disease, or long history of psychiatric drug, corticosteroids or other drug that may affect olfactory function.
* Not able to return for evaluation of olfactory function or follow-up (language, practical implementation, mental condition)
Role of (LMWH) in Prevention of Thromboembolic Complication After (TACE) in Hepatocellular Carcinoma.

Hepatocellular carcinoma (HCC) is a major health problem worldwide, and most cases are inoperable because of late presentation and underlying cirrhosis. It represents the fifth most common tumor in the world and the third most frequent cause of mortality amongst patients with cancer.

Due to the worldwide difficulties in finding liver for transplantation, hepatic resection (HR) represents the main stay of curative treatment for patients with HCC. Transcatheter arterial chemoembolization (TACE) is widely used as alternative treatments for unresectable HCC or for patients not eligible to be operated on .

TACE also could be an adjuvant therapy for resectable HCC patients after hepatectomy, which could prevent recurrence and improve long-term survival .

Thromboembolism is a well-recognised complication of malignant disease. Clinical manifestations vary from venous thromboembolism to disseminated intravascular coagulation and arterial embolism. Disseminated intravascular coagulation is most commonly observed in patients with haematological malignant disorders and those with wide spread metastatic cancer, whereas arterial embolism is most commonly observed in patients undergoing chemotherapy and in those with non-bacterial thrombotic endocarditis .

The goals of using antithrombotic therapy with TACE in HCC are to minimize mortality and to improve survival rate without provoking excessive bleeding.

Eligibility Criteria:
Inclusion Criteria:

* HCC which was not amenable to surgical resection, liver transplantation or local ablative therapy.
* The lesion had not been previously treated with surgery, radiation therapy, radiofrequency ablation, percutaneous ethanol or acetic acid injection, or cryoablation.
* Reasonable performance status as adequate hematologic function; adequate hepatic function and adequate renal function.
* Child-Pugh class A or B and no portal vein thrombosis.

Exclusion Criteria:

* Child C patients Portal vein thrombosis
Caudal Block With Bupivacaine and Dexmedetomidine Versus TAP Block With Bupivacaine Alone for Postoperative Analgesia in Pediatric Undergoing Infraumbical Surgeries

Acute pain management for pediatric surgical patients intraoperatively and postoperatively is important for their comfort and psychological impact. Children aged 3-9 years old are included in the study and are divided randomly into two groups (45 children in each):

Group D: Caudal block with bupivacaine 0.25% in a dose of (1 ml / kg) and dexmedetomidine 1μg/ kg.

Group T: TAP block with bupivacaine 0.25% in a dose of (0.5 ml / kg).


Eligibility Criteria:
Inclusion Criteria:

* Children aged 3-9 years old
* Physical status I and II class of the American Society of Anesthesiologists (ASA)
* Unilateral elective surgeries below the umbilicus

Exclusion Criteria:

* Parents or legal guardian refusal.
* History of developmental delay or mental retardation
* Contraindications to regional anesthesia as known or suspected coagulopathy, a known allergy to any of the study drugs, signs of infection at the site of caudal block.
* Hemodynamic unstable patient.
Oropharyngeal Leak Pressure Monitoring Using Baska Versus I-gel Laryngeal Mask Airway

The use of supraglottic airway devices with a gastric emptying tube in gynecological laparoscopic surgeries is growing. In addition to their ease of placement, they have low airway morbidity along with sufficient airway pressure in the Trendelenburg position and so they have been determined as an alternative to the endotracheal tube.

The Baska mask is a novel supraglottic airway device with a non-inflatable cuff, an oesophageal drainage inlet and side channels to facilitate the aspiration of gastric contents and an integrated bite-block. The Baska mask comes in four sizes, ranging from pediatric to adult. The device appeared relatively easy to insert, provided a high-quality seal with the glottic aperture and the incidence of throat discomfort appeared low.

The I-gel a single use with noninflatable cuff and drain tube is being used for airway management during anesthesia since last few years. The noninflatable cuff of I-gel is made of a soft gel-like medical grade thermoplastic elastomer. The device has a buccal cavity stabilizer, an integral bite block and an epiglottic rest with a protective ridge, which prevents down folding of epiglottis during insertion.

An oropharyngeal leak pressure or 'leak' test is commonly performed with the laryngeal mask airway to quantify the efficacy of the seal with the airway. This value is important since it indicates the feasibility of positive pressure ventilation and the degree of airway protection from supracuff soiling.

Gynecological laparoscopic surgeries are associated with a decrease in thoraco-pulmonary compliance due to pneumoperitoneum and the Trendelenburg position. Minute ventilation needs to be increased to compensate for this reduction in compliance in order to maintain end-tidal carbon dioxide during pneumoperitoneum. This increase in minute ventilation can lead to an increase in airway pressures in excess of 20 cmH2O.

Eligibility Criteria:
Inclusion Criteria:

* BMI\< 30kg/m2.
* ASA physical status: I-II.
* Operation: gynecological laparoscopic surgery
* under general anesthesia of an anticipated duration\<1h.

Exclusion Criteria:

* Patient refusal.
* History of cardiac disease, psychological disorders, respiratory diseases including asthma, renal or hepatic failure.
* Patients who have a high risk of regurgitation or aspiration based on a history of gastroesophageal reflux, hiatus hernia, diabetes and gross obesity.
* Neck pathology