cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of Prophylactic Antibiotics Therapy in Laparoscopic Cholecystectomy on Infection Rate

529 patients performed elective LCC at Chonbuk National University Hospital between April 2014 and August 2015. Total 509 patients were enrolled by inclusion criteria.

They were randomized studied by comparing with antibiotic group (n=249, AG, cefotetan 1g, 1 dose/prophylactic) and non-antibiotic group (n=260, NAG) by table of random numbers. The clinical variables were pre and post-operatively blood tests enclude WBC, ESR, CRP, body temperatures, symptoms and imaging of chest x-ray to evaluate the infections.

529 patients performed elective LCC at Chonbuk National University Hospital between April 2014 and August 2015. Total 509 patients were enrolled by inclusion criteria. They were randomized studied by comparing with antibiotic group (n=249, AG, cefotetan 1g, 1 dose/prophylactic) and non-antibiotic group (n=260, NAG) by table of random numbers. The clinical variables were pre and post-operatively blood tests enclude WBC, ESR, CRP, body temperatures, symptoms and imaging of chest x-ray to evaluate the infections.

Eligibility Criteria:
Inclusion Criteria:

patients who have diagnosed -cholecystitis with / without GB stone, GB polyp

Exclusion Criteria:

1. Suspected cholangitis and GB cancer
2. CBD stone history
3. Preoperative administration of antibiotics within 7days.
4. Suspected pregnancy
5. Open conversion.
6. Patients refuse this study
A Postoperative Sore Throat After Lumbar Spine Surgery in the Prone Position

This study was performed to compare the effect of dexmedetomidine and remifentanil on the incidence and severity of postoperative sore throat in patients undergoing spinal surgery in the prone position who are at risk of developing postoperative sore throat.


Eligibility Criteria:
Inclusion Criteria:

1. American Society of Anesthesiologists (ASA) physical status classification I and II
2. Undergoing lumbar spine surgery in prone position

Exclusion Criteria:

1. Pre-existing sore throat, hoarseness, or upper respiratory tract infection
2. Allergy to the study drugs
3. Anticipated difficult airways
4. More than two attempts at intubation
Safety and Efficacy of Kanglaite Gelcaps in Prostate Cancer

This research is being done to evaluate the safety and efficacy of the investigational Kanglaite gelcap (KLTc) on PSA in men with prostate cancer when given for twelve months.


Eligibility Criteria:
Inclusion Criteria:

* confirmed adenocarcinoma of the prostate
* undergone definitive treatment (surgery, surgery with radiation therapy, cryotherapy, radiation therapy or brachytherapy) for the primary prostate tumor with a rising PSA
* life expectancy greater than 6 months
* has Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
* use of other dietary/herbal supplements (e.g. saw palmetto, selenium, etc.) has been stable for at least 2 months prior to screening and the patient agrees not to stop or change the dose while participating in the study.
* Adequate hepatic function with serum bilirubin ≤ 1.5 times the upper institutional limits of normal, ALT and AST ≤ 2.5 times the upper institutional limits of normal
* Adequate renal function with serum creatinine ≤ 1.5 times the upper institutional limits of normal
* Adequate hematologic function (absolute neutrophil counts ≥ 1,500 mm3 and platelets ≥ 100,000 mm3)
* All electrolytes (including potassium, sodium, and serum or ionized calcium) must be within normal limits

Exclusion Criteria:

* Patients with evidence of metastatic disease would be excluded, except for presence of positive lymph nodes from the surgical pathology. Similarly, patients with radiological evidence of lymph nodes \< 2 cm that lack pathological confirmation would be eligible
* Patients with a PSA doubling time of \<6months at screening would be excluded
* Patients meeting Phoenix criteria for biochemical failure (nadir + ≥2ng/mL increase in serum PSA) who wish additional conventional therapy
* Any concurrent malignancy other than adequately treated basal or squamous cell skin cancer or superficial bladder cancer
* Any psychiatric or other disorders such as dementia that would prohibit the patient from understanding or rendering informed consent or from fully complying with protocol treatment and follow-up
* Inability to swallow capsules
* Patients with a known history of gastrointestinal disease, surgery or malabsorption that could potentially impact the absorption of the study drug
* Patients requiring the use of a feeding tube
* Receipt of prior chemotherapy
Gastric Modulator (TANTALUS® System) Versus Insulin Treatment in Obese Type 2 Diabetic Patients - a Randomized Control Trial

This study aims to analyze the pre- and post-operative clinical, hormonal and biochemical changes in moderately obese type 2 diabetic patients who are sub-optimally controlled on at least 2 anti-diabetic agents. Study participants will either receive implantation of the gastric contraction modulator or conventional treatment with insulin therapy.


Eligibility Criteria:
Inclusion Criteria:

* Able to provide written informed consent
* Adult patients aged between 18 and 60 years (inclusive)
* Male or female of Chinese ethnicity
* Type 2 diabetes mellitus with disease duration of greater than 2 and less than 10 years
* severe obesity, includes BMI 25 to 27.5 kg/m and central obesity defined by waist circumference greater than 90 cm in women and greater than 95 in men, or BMI greater than 27.5 to less than 35 kg/m
* HbA1c greater than or equals to 7.5% but less than 10% despite treated with maximum dose or maximally tolerated dose of 2 anti-diabetic drugs (OAD) with good drug compliance

Exclusion Criteria:

* On anti-obesity drugs
* On insulin treatment at the time of the recruitment
* On glitazone or incretins (dipeptidyl peptidase-4 inhibitor or glucagons-like peptide-1) treatment
* On any implantable device including cardiac pacing
* Anticipated to have MRI examinations
* Fasting C-peptide level less than 0.5g/L
* Renal impairment (defined as serum creatinine greater than 150mol/L and/or estimated glomerular filtration rate less than 60 mL/min/1.73m)
* Significant liver impairment (ALT more than 3 times upper limit of normal range)
* Active malignant disease. Patients with malignant disease who have been disease-free for at least 5 years are eligible
* Active infection
* Active and uncontrolled thyroid diseases
* Childbearing age female patients without reliable contraceptive methods
* Life expectancy less than 12 months
* Administration of another investigational drugs or procedures within 4 weeks before screening
* Any medical illness or condition as judged by the investigators as ineligible to participate the study
* Special population, e.g. prisoner, mentally disabled, investigators' student or employees
Carpal Tunnel/Amyloidosis Blood Sample Study

Carpal tunnel is an early manifestation of amyloidosis in a significant minority of patients. This specimen collection protocol will allow the investigators to screen patients with carpal tunnel syndrome for amyloidosis.

The investigators propose to assess a high risk population of patients, those with carpal tunnel syndrome, and systematically assess them for Amyloid Light-chain (AL) amyloidosis and Transthyretin-Related Amyloidosis (ATTR) with simple laboratory blood tests. The combination of serum immunofixation electrophoresis together with serum free light chain (FLC) assay approaches 100% sensitivity for identifying the monoclonal protein underlying the illness in patients with AL amyloidosis. In addition to this, testing for transthyretin gene mutations will allow the investigators to identify patients with ATTR. The investigators believe this simple screening panel (serum immunofixation and serum FLC assay and transthyretin mutation analysis) may allow the investigators to identify patients early in the course of their disease, at which point the investigators can intervene with effective treatment and spare patients a significant amount of morbidity and mortality.

Eligibility Criteria:
Inclusion Criteria:

* 1. Patients with diagnosed carpal tunnel syndrome based on Electromyography (EMG) results.
* 2. Patients with electrographic confirmation of median neuropathy at the wrist
* 3. Age ≥18 years
* 4. Ability to understand and willingness to sign a written informed consent document.

Exclusion Criteria:

* 1. Patients receiving hemodialysis
* 2. Known amyloidosis
Efficacy And Safety Of Sofosbuvir/Velpatasvir Fixed Dose Combination With Ribavirin in Chronic HCV Infected Adults Who Participated in a Prior Gilead Sponsored HCV Treatment Study

The primary objective of this study is to evaluate the efficacy, safety and tolerability of treatment with sofosbuvir/velpatasvir (Epclusa®; SOF/VEL) with ribavirin (RBV) for 24 weeks in adults with chronic hepatitis C virus (HCV) infection who participated in a prior Gilead sponsored study and did not achieve sustained virologic response (SVR).


Eligibility Criteria:
Key Inclusion Criteria:

* Willing and able to provide written informed consent
* HCV genotype determined by the Central Laboratory
* HCV RNA \> LLOQ at screening
* Participated and completed a Gilead sponsored HCV treatment study of direct acting antiviral (DAA) containing regimens.
* Male and female of childbearing potential must agree to use protocol specified method(s) of contraception

Key Exclusion Criteria:

* Current or prior history: Clinically-significant illness (other than HCV) or any other major medical disorder that may interfere with treatment, assessment or compliance with the protocol; individuals currently under evaluation for a potentially clinically-significant illness (other than HCV) are also excluded.
* Screening ECG with clinically significant abnormalities
* Laboratory results outside of acceptable ranges at screening
* Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
NANOS Neck Preserving Hip Stem

The objective of this study is to determine the long-term safety and effectiveness of the NANOS neck preserving stem in terms of radiographic and clinical performance as well as short-, mid- and long-term survivorship

The goal of this multicenter clinical observation is to validate short-, mid-, and long-term outcome (efficacy and safety) of the NANOS neck preserving hip stem.

Effectiveness Measures:

* Evaluation of function, range of motion (ROM) and pain as assessed by Harris Hip Score, HOOS Score \[4-6\], UCLA Activity Rating \[7\]
* Radiographic changes as defined by radiolucent lines, osteolysis, hypo- and hypertrophy, implant loosening or migration

Safety evaluations:

* Intra- and peri-operative device-related adverse events (AE) and complications up to discharge
* Postoperative AE up to 10 years

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria:
* Patient requires Primary total hip replacement (THR) to the affected side, unilateral or bilateral. Bilateral only if \>3 months after the first THR
* Patient agreed to participate in the MCO study by signing the Informed Consent form.
* Age of patient at date of surgery 18 to 65 years
* Patient is likely to comply with study follow-up requirements

Exclusion criteria:

* Previously failed endoprosthesis and /or THR components in relevant hip
* Patient has proven osteoporosis
* Pronounced coxa valga with a femoral neck angle \> 145º
* Pronounced coxa vara with a femoral neck angle \< 125º
* History of infection in the affected joint; systemic infections
* Grossly insufficient femoral or acetabular bone stock in the involved hip where a revision cup is indicated
* Spinal disease with neurologic movement disorders
* Alcoholism or addictive disorders
* ASA score is 3 or 4
* Body mass index (BMI) \> 30
* Patient is pregnant or being pregnant during follow up intervals
* Patients understanding of the language is insufficient for understanding the Patient Information and Consent
The Medasense Study

Despite various efforts there is still the need for adequate monitoring of pain and nociception during anesthesia. In a previous protocol the investigators measured pain responses during anesthesia based on single end-points, eg heart rate,blood pressure and pulse transit time. None of these parameters provided sufficient information regarding nociception. The investigators therefore want to further investigate this matter using a composite parameter, the Nociception Level or NoL. The NoL is a novel index that measures the magnitude of the autonomic response to painful stimuli. The NoL combines information from several physiological parameters, which represent different autonomic pathways. The multi-parameter approach empowered with state-of-the-art signal processing and machine learning techniques. In the current study the investigators will measure the NoL in ASA 1-3 patients undergoing elective surgery under general anesthesia. The investigators will measure NoL responses and the occurrence of patient movement upon the administration of a painful stimulus: Introduction of the laryngoscope, Insertion of the endotracheal tube, Insertion of the gastric tube, Insertion of the bladder catheter and Skin incision.


Eligibility Criteria:
Inclusion Criteria:

* Age: 18-80 years;
* Sex: male or female;
* Surgery: Any surgery under general anesthesia;
* ASA status: 1, 2 or 3.

Exclusion Criteria:

* Age: \< 18 or \> 80 years;
* Unable to give written informed consent;
* Pregnancy/lactation;
* Extreme obesity: BMI \> 35;
* Perceived difficult intubation.
* Patients requiring a rapid sequence induction
* Patients on beta-blockers
Pharmacological Predictors of Successful Cyclosporine Acute GVHD Prophylaxis in Children Undergoing HSCT

The specific objectives of this study are:

Primary:

1)To determine the relationship between cyclosporine AUC achieved prior to engraftment and severe aGVHD (grade III and IV)

Secondary:

1. To determine the relationship between individual concentration-time points achieved prior to engraftment and severe aGVHD (grade III and IV)
2. To validate the previously developed LSS to determine cyclosporine AUC after IV administration at steady state and
3. To describe the relationship between cyclosporine AUC and individual concentration-time points achieved prior to engraftment and other HSCT outcomes (clinically significant aGVHD (grade II to IV), hypertension, engraftment failure, relapse


Eligibility Criteria:
Inclusion Criteria:

* less than 18 years of age
* undergoing allogeneic myeloablative HSCT at one of the participating centres and
* scheduled to receive cyclosporine for aGVHD prophylaxis
* minimum patient weight:
* 6.4kg if \< 6 months old or 7.2kg if \> 6 months old

All patients or guardians will provide informed consent or assent as appropriate. Initial contact will be made by a member of the patient's current care team. Consent will be obtained by a co-investigator or the CTSU personnel.

Exclusion Criteria:

-receipt of voriconazole or posaconazole within 14 days of the first cyclosporine dose or at any time until engraftment
Patient-centered Outcomes After Permanent Female Sterilization Procedure(POPS Trial)

The purpose of this study is to compare and capture key elements of the patient experience, quality of recovery, preferences and satisfaction after laparoscopic salpingectomy done via 3 different routes.


Eligibility Criteria:
Inclusion Criteria:

* Premenopausal women scheduled to undergo an elective sterilization surgery regardless of parity
* non-prolapsed uterus
* Patients should able to provide written consent

Exclusion Criteria:

* Women who have relative contra-indication to vaginal peritoneal access such as: history of rectal surgery, suspected recto-vaginal endometriosis based on clinical history and examination, suspected malignancy, pelvic inflammatory disease, active lower genital tract infection, virginity or pregnancy
* Postpartum (immediate) tubal sterilization
* Tubal sterilization during a cesarean section
Voriconazole Compared With Itraconazole in Preventing Fungal Infections in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation

RATIONALE: Antifungals, such as voriconazole and itraconazole, may be effective in preventing fungal infections in patients who are undergoing allogeneic stem cell transplantation.

PURPOSE: This randomized clinical trial is studying voriconazole to see how well it works compared to itraconazole in preventing fungal infections in patients who are undergoing allogeneic hematopoietic stem cell transplantation.

OBJECTIVES:

* Compare the safety and tolerability of voriconazole vs itraconazole for the prevention of fungal infections in patients undergoing allogeneic hematopoietic stem cell transplantation.

OUTLINE: This is a randomized study. Patients are stratified according to donor type (related vs unrelated). Patients are randomized to 1 of 2 treatment arms.

* Arm I: Beginning after allogeneic hematopoietic stem cell transplantation (AHSCT), patients receive voriconazole IV twice daily on days 1-14 and then orally\* twice daily on days 15-100.
* Arm II: Beginning after AHSCT, patients receive itraconazole IV twice daily on days 1-2, once daily on days 3-14, and then orally\* twice daily on days 15-100.

NOTE: \*Patients unable to tolerate oral medication may continue IV medication beyond day 14.

In both arms, treatment continues in the absence of unacceptable toxicity or an invasive fungal infection. Patients requiring corticosteroid therapy for graft-versus-host disease continue to receive voriconazole or itraconazole beyond day 100.

Patients are followed until day 180 post-transplantation.

PROJECTED ACCRUAL: A total of 150 patients (75 per treatment arm) will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Undergoing allogeneic hematopoietic stem cell transplantation
* No invasive yeast infection within the past 8 weeks

  * Colonized or superficial infection allowed
* No documented or probable aspergillus or mold infection within the past 8 weeks
* Patients with a history of candidemia must have negative blood cultures and no clinical signs of candidemia

PATIENT CHARACTERISTICS:

Age

* 12 and over

Performance status

* Not specified

Life expectancy

* Not specified

Hematopoietic

* Not specified

Hepatic

* Not specified

Renal

* Not specified

Other

* Not pregnant or nursing
* Fertile patients must use effective contraception
* No prior allergy or intolerance to imidazoles or azoles (e.g., fluconazole, itraconazole, voriconazole, ketoconazole, miconazole, or clotrimazole)

PRIOR CONCURRENT THERAPY:

Biologic therapy

* See Disease Characteristics

Chemotherapy

* Not specified

Endocrine therapy

* Not specified

Radiotherapy

* Not specified

Surgery

* Not specified

Other

* At least 1 week since prior amphotericin B or fluconazole for candidemia
* No concurrent therapy with any of the following:

  * Rifampin
  * Rifabutin
  * Phenobarbital
  * Phenytoin
  * Carbamazepine
  * Oral midazolam
  * Triazolam
  * Terfenadine
  * Astemizole
* Concurrent topical antifungal agents for superficial fungal infections allowed
Aripiprazole in the Treatment of Patients With Schizophrenia and Symptoms of Obsessive Compulsive Disorder (OCD)

To evaluate the effectiveness of flexible doses (15-30mg) of Aripiprazole in the treatment of patients with schizophrenia and co-morbid symptoms of OCD in the outpatient setting. The overall effectiveness of Aripiprazole will be evaluated by use of the Brief Psychiatric Rating Scale(BPRS), Yale-Brown OCD scale and Clinical Global Impression-Improvement(CGI-I) scale.

Symptoms of OCD is a rather common co-morbid condition in patients with Schizophrenia. Some studies suggest that obsessive-compulsive symptoms may be present in 7.8-46% of schizophrenic patients and who seem to be poorly responsive to drug therapy. The serotonergic medications in combination with cognitive-behavioral therapy stil remain the preferred treatment for OCD symptoms. There are controversial data regarding effect of neuroleptics on symptoms of OCD. It was noted that the use of Risperdone, Quatiapine and Clozapine might aggravate OCD symptoms. Serotonin antagonism of these neuroleptics is believed to exacerbate obsessive-compulsive symptoms in schizophrenia. On the other hand, Pourovsky M. at(2000) reported three cases of Schizophrenia with symptoms of OCD successfully treated with Olanzapine.One of our patients with Schizophrenia and co-morbid symptoms of OCD who was unsuccessfully treated with various neuroleptics in combination with anti-obsessive agents,demonstrated significant improvement in both Schizophrenic and obsessive compulsive symptoms after she was switched to Aripiprazole. This result encouraged us to initiate pilot study of effectiveness of Aripiprazole in the treatment of specific population of schizophrenic patients with symptoms of OCD.

Eligibility Criteria:
Inclusion Criteria:

* Man and Women 18-65 years of age.
* Patients who are capable of giving Informed Consent and fluent in English.
* Patients who have DSM IV -Diagnosis of schizophrenia with co-morbid OCD symptoms and BPRS score averaging from mild to moderate (3-4).
* Patients whose obsessive symptoms are not optimally controlled and require a change of treatment.YBOCS score of more than 16.

Exclusion Criteria:

* Outside the age range of 18-65 years.
* Patients with current evidence(past three months) of substance abuse.
* Women of child bearing age who are unwilling to use acceptable methods of contraception.
* Patients who have had recent treatment with long-acting antipsychotic.
* Patients who are suicidal or who have history of recent suicidal attempt.
* History of significant medical condition e.g. seizures, cardiovascular, endocrine,gastrointestinal,renal or respiratory diseases.
TRX4 Monoclonal Antibody in Type 1 Diabetes (T1 DM)

The purpose of this study is to optimize several multi-dose regimens of otelixizumab, determine the highest biologically active dose, evaluate biomarkers and surrogates of efficacy, and to evaluate the effects of each multi-dose regimen of otelixizumab against standard safety and efficacy parameters.


Eligibility Criteria:
Inclusion Criteria:

* Adults 12 to 45 years old who are in good general health
* Confirmed diagnosis of insulin requiring type 1 diabetes mellitus with good glycemic control
* Measurable C-peptide levels

Exclusion Criteria:

* Females must not be pregnant or lactating and willing to practice contraception
* No prior malignancy, other than non-melanoma skin cancer
* Body Mass Index (BMI) \> 32 at screening