cyrilzakka/clinical-trials huggingface dataset:
Comparison of Efficacy of Single Oral Dose Fluconazole and Itraconazole in Patients With Pityriasis Versicolor

Pityriasis versicolor (PV) also called tinea versicolor is a common superficial chronic fungal infection of the skin caused by species of lipophilic yeast known as Malassezia species. Itraconazole is an oral synthetic triazole while fluconazole is an oral synthetic bis-triazole compound. Only a few studies are available to find a direct comparison of the efficacy of single dose of oral fluconazole (400 mg) and oral itraconazole (1000 mg) in the treatment of PV. The objective of the study was to compare the efficacy of single dose fluconazole (400 mg stat) to single dose itraconazole (1000 mg stat) in the treatment of pityriasis versicolor in the local population of Pakistan.

Pityriasis versicolor (PV) also called tinea versicolor is a common superficial chronic fungal infection of the skin caused by species of lipophilic yeast known as Malassezia species. Itraconazole is an oral synthetic triazole while fluconazole is an oral synthetic bis-triazole compound. These both acts by inhibiting the cytochrome-P450 dependent 14-alpha-demethylation step in the formation of ergosterol thereby impairing the functions of certain membrane bound enzyme systems, and ultimately inhibiting the growth of fungi. Both the drugs have been studied in different dose regimen, however, there are variable results in studies on this subject. There is still no standard drug and its dosage that can ensure complete cure. Fluconazole (300mg) in 2 doses with an interval of one week has been used effectively, however, fluconazole (400 mg) as a single dose has also been used, and found to cure the PV. Itraconazole 200 mg/day can be given in a dose of for 7 days however, higher concentrations of itraconazole in the stratum corneum are achieved that persist for 3-4 weeks so the drug is presumed to be effective even in a single dose. Therefore, only a few studies are available to find a direct comparison of the efficacy of single dose of oral fluconazole (400 mg) and oral itraconazole (1000 mg) in the treatment of PV. The objective of the study was to compare the efficacy of single dose fluconazole (400 mg stat) to single dose itraconazole (1000 mg stat) in the treatment of pityriasis versicolor in the local population of Pakistan.

Eligibility Criteria:
Inclusion Criteria:

* All the patients above 18 years of age
* Diagnosed with pityriasis versicolor

Exclusion Criteria:

* Those patients who had received any antifungal treatment during last 1 month
* pregnancy
* lactation
* history of renal disease hepatic disease or malignancy
* history of hepatic disease
* history of malignancy
Immediate Loading of Bone Anchored Hearing Devices

Bone anchored hearing aids provide a hearing solution for patients that are unable to wear traditional air conduction hearing aid solutions. The technology of the devices has developed significantly over the last 510 years and patients are gaining access to their sound processor at a much earlier stage than when first brought onto the market. Despite this the investigators feel there is still room to develop this and with the new abutments with specialised hydroxyapatite coating it is hoped that patients can be loaded with their sound processor in the day of surgery. This study will compare abutment stability between two groups of patients. Those loaded immediately with their sound processor and those loaded traditionally at 2 weeks post operatively.

At routine followup appointments patients will have the stability of their abutment checked and the investigators will compare to see if loading earlier had any detrimental effects on osteointegration and the stability of the abutment.

Based on the favourable outcomes and high stability record for the BA400 it is anticipated that the time to processor fitting may be further reduced, provided favourable bone conditions at the implant site and provided satisfactory soft tissue status at the time of loading. It is hypothesised that loading immediately at the time of surgery is possible with comparable short and long term outcomes when compared to standard loading at 2 weeks


Eligibility Criteria:
Inclusion Criteria:

* Patients eligible for receiving the Baha system.

Exclusion Criteria:

* Adult patients, i.e. ≥18 years
* Eligible for the Baha system
* Bone thickness at the implant site of at least 4 mm
* No known disease or treatment that compromises / will compromise the bone quality at the implant site
Intraoperative Sedation and Postoperative Delirium

Delirium are common after orthopedic surgery in the elderly and are directly associated with loss of independence, reduction in the quality of life and increased mortality. The cause of postoperative delirium still remains unclear and may be multifactorial. The aim of this retrospective study is to examine prevalence of postoperative delirium according to the use of dexmedetomidine or propofol in elderly patients undergoing orthopedic surgery under regional anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent orthopedic surgery under regional anesthesia
* age of 65 years or greater

Exclusion Criteria:

* General anesthesia
* age \< 65 years
* central nervous system disease, including dementia and Parkinson's disease
* Patients who were not received sedation with propofol or dexmedetomidine during the operation
Adipose Distribution and Atherosclerosis

To relate distribution of adipose tissue measured by a then new imaging technique, Magnetic Resonance Imaging (MRI) to extracranial carotid atherosclerosis, cardiovascular disease risk factors, and to more conventional measures of fat distribution such as body mass index (BMI) and waist/hip ratio. The primary hypothesis was that patients with extracranial carotid atherosclerosis (cases) had more intra-abdominal fat and a higher ratio of intra-abdominal fat to total or subcutaneous fat than age-sex-race matched controls.

BACKGROUND:

The study was ancillary to an NIH funded population-based project, the Atherosclerosis Risk in Communities Study (ARIC) that is ongoing in Forsyth County, North Carolina.

DESIGN NARRATIVE:

Using MRI, the investigators sought to demonstrate strong relationships between intra-abdominal fat and a number of cardiovascular disease risk factors, including history of hypertension, diabetes, cigarette smoking, family history of cardiovascular disease, plasma concentrations of triglyceride, high density lipoprotein (HDL) cholesterol, HDL2 cholesterol, apo A1, Apo B, postprandial lipid response to a fat rich meal, glucose, insulin, sex hormone binding globulin, and total and free testosterone. Certain other risk factors were less certain to show a relation to intra-abdominal fat as measured by MRI, including various hemostatic factors, as well as certain dietary factors such as consumption of alcohol, dietary fat, and cholesterol, but this research afforded an opportunity to explore these relationships. Finally, the investigators proposed to relate intra-abdominal fat to more conventional measures of fat distribution (waist/hip ratio, subscapular skinfold thickness, etc.) in an attempt to identify strong correlates of intra-abdominal fat that could be more easily measured.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) recor

Eligibility Criteria:
No eligibility criteria
S0010 506U78 in Treating Patients With Recurrent or Refractory Acute Lymphocytic Leukemia

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of 506U78 in treating patients who have recurrent or refractory acute lymphocytic leukemia.

OBJECTIVES:

* Assess the complete remission rate in patients with recurrent or refractory non-T-cell acute lymphocytic leukemia when treated with 506U78.
* Determine the frequency and severity of toxic effects of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive 506U78 IV over 2 hours on days 1, 3, and 5. Treatment continues every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every month for 6 months, every 3 months for 1 year, and then every 6 months for 3.5 years.

PROJECTED ACCRUAL: A total of 20-35 patients will be accrued for this study within 18 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of acute lymphocytic leukemia (ALL)

  * FAB class L1-L2
* Non-T-cell ALL (lymphocytic immunophenotype markers CD19+, CD5-, and CD7- in peripheral blood, bone marrow, or in at least 1 extramedullary disease site)

  * Coexpression of myeloid antigens CD13 or CD33 allowed
* Histologically confirmed extramedullary disease in the absence of bone marrow or blood involvement allowed

  * CD3 and myeloperoxidase marker negative
* Meeting 1 of the following criteria for recurrent/refractory disease:

  * Refractory to standard induction regimen including at least vincristine and prednisone
  * Recurrence after response after prior induction therapy
  * Recurrence and failure on subsequent treatment
* No CNS involvement
* Must be registered on SWOG-S9910 and SWOG-9007

PATIENT CHARACTERISTICS:

Age:

* 16 and over

Performance status:

* Zubrod 0-3

Life expectancy:

* Not specified

Hematopoietic:

* Not specified

Hepatic:

* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* SGOT or SGPT no greater than 3 times ULN

Renal:

* Creatinine no greater than 2 times ULN

Other:

* Not pregnant or nursing
* Fertile patients must use effective contraception
* No grade 2 or greater neuropathy
* No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or any other adequately treated stage I or II cancer in complete remission

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* See Disease Characteristics

Endocrine therapy

* Not specified

Radiotherapy

* Not specified

Surgery

* Not specified
Effects of Preoperative Immunonutrition in Patients Undergoing Hepatectomy

The purpose of this study is to determine whether preoperative immunonutrition is effective on infectious complication and Th1/Th2 differentiation in patients with major hepatectomy.

The investigators reported that preoperative immunonutrition improve the incidence of postoperative infectious complication in patients after hepatectomy, and modulation of Th1/Th2 differentiation may play important roles in this effect.

Object of this study is to investigate the effects of preoperative immunonutrition on incidence of postoperative infectious complication, and Th1/Th2 balance after hepatectomy.

Eligibility Criteria:
Inclusion Criteria:

* hepatectomy

Exclusion Criteria:

* age younger than 18 years
* ongoing infection
* gastrointestinal obstruction
* respiratory dysfunction
* cardiac dysfunction
* hepatic dysfunction
* renal failure
* history of recent immunosuppressive or immunological disease
* preoperative evidence of widespread metastatic disease
Levita Magnetic Grasper Device Safety and Performance Study

The purpose of this study is to determine the Levita Magnetic Grasper Device Safety and Performance in Laparoscopy.


Eligibility Criteria:
Inclusion Criteria:

* Patient is between 18 and 60 years of age

  * Undergoing elective cholecystectomy due to:
  * Cholelithiasis (Gallbladder stones \< 2.5cm in longer measurement (length or width))
  * Gallbladder polyps as assessed by ultrasound
  * Absence of non-correctable coagulopathy (INR \< 1.4 or, platelet count of \< 50,000/mcl)
  * Patient has a body mass index (BMI) ≤ 35 kg/m2 and over 20
  * Patient, or authorized representative, signs a written Informed Consent form to participate in the study, prior to any study mandated determinations or procedure

Exclusion Criteria:

* Emergency presentation with acute gallbladder disease

  * Pancreatitis
  * Jaundice
  * Scleroatrophic gallbladder as shown by ultrasound
  * Biliary tract stones diagnosed before or during surgery
  * Acute cholecystitis
  * Gallbladder Empyema
  * Ongoing peritoneal dialysis
  * Previous abdominal surgery or laparotomy (presence of any previous upper umbilical incision)
  * Presence of umbilical hernia or previous umbilical hernia
  * American Society of Anesthesiologists (ASA) score of III or IV
  * Patient is undergoing treatment for chronic pain of any origin
  * Significant comorbidities: cardiovascular, neuromuscular, chronic obstructive pulmonary disease, and urological disease (renal failure)
  * Patients with signs of gallbladder perforation diagnosed by ultrasound
  * Suspicion of biliary cancer
  * Patients with severe peritonitis
  * Contraindications to pneumoperitoneum
  * Known allergy to paracetamol or NSAIDs
  * Patients with metallic implants (such as pacemakers, prosthesis, etc)
  * Previously diagnosed or suspected of having a history of choledocholithiasis based on any alterations in plasma hepatic enzymes
  * Has a biliary tract \> 7mm in size as determined by ultrasound
  * Has a gallbladder wall thickness that is \> 5mm
  * Diabetic Blood coagulation issues
  * Has signs of hepatic endocrinology (i.e: cirrhosis, liver failure, increase in liver enzymes, etc.)
  * History of endoscopic papillotomy (i.e: Preoperative indication of endoscopic retrograde cholangiopancreatography (ERCP)
  * Patient is pregnant or wishes to become pregnant during the length of study participation or lactation
  * Patient is not likely to comply with the follow-up evaluation schedule
  * Patient is participating in a clinical trial of another investigational drug or device
  * Patient is mentally incompetent or a prisoner
  * Known or suspected drug or alcohol abuse
  * Patient has systemic infection or evidence of any surgical site infection (superficial or organ space)
  * Patient has compromised immune system or autoimmune disease (WBC \< 4000 or \> 20,000), including prior or pending treatment for HIV or Hep. C
  * Patient intra-operatively needs an additional surgery while undergoing elective cholecystectomy
Real Time In-Vivo Dosimetry For Gynecologic Brachytherapy

This is an observational study. The purpose is to determine the feasibility of using a novel nano-scintillator fiber-optic dosimeter (nanoFOD) for the real time dosimetric monitoring of brachytherapy treatment. Women with gynecologic cancers treated with brachytherapy as part of their standard therapeutic regimen will represent the study population.

Brachytherapy is a curative treatment for many malignancies, brachytherapy delivers a high radiation dose to a very small and well-specified target within a patient with cancer. Yet there is no current convenient, inexpensive, real time method of confirming the radiation dose delivered. There is no current monitoring or fail-safe device for radiation oncologists and their patients if the radiation dose becomes too high, especially to radiation sensitive organs, or conversely if the target receives too little dose.High dose-rate(HDR) brachytherapy is a highly advanced radiation-based cancer treatment, where a very small radioactive source, Iridium-192, is placed in or near the tumor through a catheter or channel. This provides a high radiation dose to the tumor in 5-15 minutes with a precise location, while minimizing radiation exposure to surrounding tissue and organs. This protocol will determine the feasibility of using a novel nano-material based fiber-optic dosimeter (nanoFOD) device, with dimensions less than 1 mm wide, to measure real-time, pin-point, in-vivo radiation dose given during radiation therapy treatments. The size of the device allows placement through a catheter or channel near areas of interest, or within already placed brachytherapy delivery catheters.

Eligibility Criteria:
Inclusion Criteria:

* Histologically documented neoplasm of the female genital tract.
* Planned brachytherapy as part of standard of care treatment.
* Age \> 18 years
* Able to provide and execute informed consent

Exclusion Criteria:

* Any clinical scenario in which the nanoFOD placement or reading would compromise the treatment efficacy, or endanger the patient in any way.
Immersive Mixed Reality Simulation to Evoke Empathy

This is a quantifiable study evaluating the ability of a mixed reality (MR), immersive simulation experience to evoke empathy in anesthesiology trainees. Quantitative methodologies will be employed using standardized questionnaires including the The Jefferson Scale of Physician Empathy for Health Professions Students, (HP-version). Trainees will assess their preliminary, baseline empathy using the Jefferson Scale and after the simulation and debrief, will reassess empathy scores, once again using the Jefferson Scale. A satisfaction survey to assess simulated patient embodiment as a valuable exercise and contributor to empathy education curriculum.


Eligibility Criteria:
Inclusion Criteria:

* Trainees or personnel working and/or volunteering at Lucile Packard Children's Hospital Stanford / Stanford Health Care facilities
* 18 years and older

Exclusion Criteria:

* a history of severe motion sickness
* currently have nausea
* have a history of seizures
* are uncomfortable wearing a \~7 pound weighted vest.
Adhesive Tape in Episiotomy Repair

This study will be undertaken to question the superiority of use skin adhesive tape (® Steri-Strip) closure system in wound healing over the traditional running absorbable subcuticular suture technique in perineal repair after episiotomy.

Episiotomy is the most common operating procedure that most obstetricians will perform in their lifetime. Because it is so common and considered minor surgery, teaching students or interns the principles and techniques usually is left to the most junior of residents

The optimal method for episiotomy and perineal trauma repair following childbirth remains open to debate and a great cause of concern to doctors, midwives, and the public

Apparently, the ideal method for perineal repair should be quick, painless, easy to perform and preferably, without increase in pain and dyspareunia during the puerperium

This study will be undertaken to question the superiority of use skin adhesive tape (® Steri-Strip) closure system in wound healing over the traditional running absorbable subcuticular suture technique in perineal repair after episiotomy.

Eligibility Criteria:
Inclusion Criteria:

* Primiparous.
* First and second degree perineal tear.
* Normal not instrumental vaginal delivery; spontaneous not induced.
* Patient willingness to randomize to episiotomy repair technique.

Exclusion Criteria:

* Previously existing local infections or lesions.
* Third and forth degrees perineal tear.
* Maternal diseases interfere with wound healing or causing excessive bleeding (coagulopathy, collagen disease, diabetes mellitus, known immunodeficiency, immunosuppressive treatment).
* Known hypersensitivity to adhesive materials
* Maternal unwillingness to undergo randomization.
* Participation in another intervention-trial with interference of intervention and/or outcome of this study.
Treatment of Post-Surgical Scars With Traditional Ablative Er:YAG Versus Fractional Ablative Er:YAG

The investigators will compare the efficacy of Traditional Ablative Er:YAG Versus Fractional Ablative Er:YAG in a split scar study. The patient will receive a month treatment for 3 months. Then follow up for the next 2 months.

Background: Scars are a common complaint of patients at presentation to a dermatology office. To optimize cosmetic results, the investigators propose to compare erbium-doped yttrium aluminium garnet (Er:YAG) laser therapy on two different settings: traditional ablative versus fractional ablative. A side to side comparison of split scars will be done to evaluate the two settings. Fractionated photothermolysis (fractional setting) has improved the field of laser surgery by allowing the surgery to target microscopic treatment zones (MTZ). MTZ's allow for cylinders of damage created by laser surgery to be surrounded by normal, unaffected skin. This acts as a reservoir for healing and allows for the microwounds created by laser treatment to heal quickly and with minimal discomfort.

Objective: To compare efficacy and cosmetic appearance of scars treated with Er:YAG ablative laser on traditional ablative resurfacing setting versus fractional ablative resurfacing setting.

Methods: Enroll 20 patients for nonsurgical treatment of surgical scars. Half of each scar will be treated with the Er:YAG laser on the traditional ablative setting and the other half of the scar will receive Er:YAG treatment with the fractional ablative setting. The patients will receive 3 treatments at monthly intervals. They will follow up at 1 and 2 months after the treatment. Pictures of the scar will be taken at a 45 degree and 90 degree angle at baseline, before each treatment, after each treatment, and at all follow up appointments. The patients will be blinded as to which side is treated with which laser setting. At the end of the trial, they will be offered the chance to have the side they felt had less improvement treated with the laser device that had been used on the contralateral side of the scar.

Results: A panel of three blinded dermatologists will evaluate the scar on a well-established five point grading scale for erythema, height and texture, and overall cosmetic outcome. The mean, standard deviation, and kappa values will be calculated. Patients will be asked the same scar evaluation questions as the panel as well as their overall satisfaction, how much pain was associated with the procedure, which laser they preferred, and would they recommend treatment to a friend or family member.

Eligibility Criteria:
Inclusion Criteria:

* over 8 weeks s/p scar
* linear closure
* visibly symmetric scar
* over 18 years old

Exclusion Criteria:

* concomitant treatment of involved skin
* propensity for keloid scarring
* use of oral retinoids for the past 1 year
* pregnancy
* immunosuppression
* prior laser to the area
Immuno 1: Immune Reconstitution Following Conventional or High-Dose Chemotherapy With Stem Cell Transplant

The purpose of this study is to conduct an analysis of the influences of

1. conventional chemotherapy
2. high-dose chemotherapy followed by autologous stem cell transplant
3. high-dose chemotherapy followed by allogeneic stem cell transplant on the recovery of the immune system.

Detailed analysis will help to better understand the pathways of recovery of the immune system following chemotherapy as well as the pathways of recovery of the immune system following autologous or allogeneic stem cell transplantation.

Detailed analysis will be performed at preselected time points following therapy by

* standard flow cytometry in combination with intracellular cytokine/antigen staining
* spectratype analysis
* TREC assays

Eligibility Criteria:
Inclusion Criteria:

* Acute leukemia treated according to current ALL-BFM 2002 protocol
* Solid tumor treated according to current GPOH-protocol
* Medulloblastoma treated according to HIT-2000 protocol
* High-dose chemotherapy followed by autologous stem cell transplantation
* High-dose chemotherapy followed by allogeneic stem cell transplantation
* Written consent according to our institutional guidelines

Exclusion Criteria:

* No written consent