cyrilzakka/clinical-trials huggingface dataset:
Comparative Trial of Micafungin Versus Fluconazole for Treating Esophageal Candidiasis

To determine the efficacy and safety of IV Micafungin versus IV Fluconazole in the treatment of patients with Esophageal Candidiasis


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of esophageal candidiasis confirmed by endoscopy
* Negative pregnancy test in females of childbearing potential

Exclusion Criteria:

* Pregnant or nursing
* Evidence of liver disease
* Presence of another active opportunistic fungal infection and/or receiving acute systemic therapy for an opportunistic fungal infection
* Concomitant esophagitis caused by herpes simplex virus or cytomegalovirus
* Receipt of an oral or topical antifungal agent within 48 hours or a systemic agent within 72 hours of first dose of study drug
* Non-responsive to therapy in any prior systemic antifungal clinical trail
* History of \> 2 episodes of esophageal candidiasis requiring systemic antifungal therapy
* History of anaphylaxis attributed to azole compounds or echinocandin class of antifungals
Cognitive Interventions and Nutritional Supplementation for Patients With Long-lasting Back Pain

CINS is a large multicentre study which aims to test out the effect of 4 different interventions, namely a brief cognitive intervention (BI), a more extensive cognitive behavioural intervention (CBT), and 2 different nutritional supplementations (seal oil and soy oil) in a population of chronic low back pain patients sicklisted for 2-10 months.

The treatment principles for low back pain, and also other types of non-specific muscle pain, have changed dramatically over the last 10 to 15 years; from traditional treatment like bed rest and inactivity to more active treatment strategies ("the back pain revolution"; Waddell et al 1997). Norwegian research has been in the forefront, particularly in demonstrating the clinical and cost effective brief interventions (BI) (Indahl et al., 1995, 1998; Hagen et al 2000, 2004, Brox et al 2003, Storheim et al 2003). However, about 30% of the patients do not recover or return to normal social and working life. The aim of this study is therefore to see if a longer cognitive behavioural intervention (CBT) has an additional benefit to BI, and to compare this with a potentially beneficial dietary supplement.

Eligibility Criteria:
Inclusion Criteria:

* Patients sicklisted 2-10 months for low back pain
* The following diagnosis are included: L02, L03, L84 and L86

Exclusion Criteria:

* Being off the sick list
* Pregnancy
* Osteoporosis
* Cancer
* L diagnoses suggesting recent low back pain trauma
* Specific spinal or other injuries which may account for the current back pain
* Serious psychiatric pathology
American Migraine Prevention Study

The purpose of this study is to evaluate the use of nutritional supplementation and dietary management for the reduction in frequency, duration, and intensity of migraine headache pain.

AMPS, the American Migraine Prevention Study Program is a home based nutritional study for migraine prevention. It is designed to evaluate a nutritional supplement along with proper diet, and trigger management that may prevent migraines or reduce the frequency, duration and intensity of migraine headache pain.

The AMPS Program is availalbe nationwide. It is a home based study program.

During the three month study period, participants will be asked to take a daily nutritional supplement and follow a recommended diet to avoid potential migraine triggers. Participants will be asked to maintain a headache log and submit headache questionnaires at the beginning and end of the study. Participants do not have to travel and can participate from their current location.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of migraines
* Ages 18-72
* Migraines more than once per month
* Diagnosed migraines for more than one year

Exclusion Criteria:

* Pregnant/nursing
Pilot Study Assessing Breast Temperature in Breast Cancer Patients

Our investigators plan to measure the skin on the breast six months after breast reconstruction. The non-reconstructed breast will be used as the control for subject with unilateral reconstruction only. For those who have BILATERAL reconstruction, a core temperature will be obtained from the ear.

Many factors influence outcomes following mastectomy and breast reconstruction. Cutaneous sensation, degree of scar formation, nipple projection and overall appearance are well correlated with patient satisfaction. However, very little data exists on the importance of skin temperature after mastectomy and reconstruction. Our investigators have noted that a number of patients report their reconstructed breast is cold and relate this as a source of dis-satisfaction. In these patients, it is unclear if 1) the reconstructed breast skin is cold and if so 2) can something can be done to improve this. Our investigators hypothesize that cutaneous breast temperature may be altered after mastectomy and reconstruction. This may be dependent on the reconstruction technique and other patient factors. In this pilot study, our investigators aim to establish techniques for evaluating cutaneous breast temperature following mastectomy and reconstruction. Our investigators hope to establish baseline data to develop an understanding of breast skin temperature after mastectomy and reconstruction.

Our long-term goals are to evaluate how cutaneous breast temperature may contribute to patient satisfaction. Our investigators also hope to determine which patients are at risk for developing a cold breast after surgery. Finally, our investigators will setup a prospective trial evaluating techniques to correct this problem and improve patient satisfaction.

Eligibility Criteria:
Inclusion Criteria:

* For post-reconstruction patients: all patients who have undergone mastectomy and breast reconstruction at Duke and are seen in clinic no sooner than 3 months after reconstruction and no more than 5 years after reconstruction.

Exclusion Criteria:

* Metastatic malignancy of any kind.
* Subjects with a history of breast implant augmentation prior to mastectomy and reconstruction.
* Subjects who cannot give an informed consent.
Effects of Foam Rolling Prior to PNF Stretching on Hamstring Flexibility and Thigh Skin Temperature in Healthy Subjects

There is no study investigating the hamstring flexibility and skin temperature after combined warm-up techniques especially PNF and foam rolling. The main purpose of this study is to investigate the effects of foam roller application prior to proprioceptive neuromuscular facilitation stretching on hamstring flexibility and thigh skin temperature in healthy subjects.Secondly, it is aimed to compare the effects between non-vibration foam rolling and vibration foam rolling on measured parameters.

In this study forty-eight subjects will be voluntarily recruited into the study according to inclusion criteria. Participants will be randomly assigned to Vibration Foam Rolling + PNF stretching, Non-Vibration Foam Rolling + PNF stretching, only PNF stretching and control group. Subjects will be evaluated before, immediately after and 30 minutes after intervention. Hamstring flexibility will be evaluated with Active Knee Extension Angle (AKEA) Test and functionally Sit and Reach test. Thigh skin temperature will be evaluated with thermographic imaging.

Eligibility Criteria:
Inclusion Criteria:

* 18 years and older,
* Having limitation of 20 degrees or more in knee extension angle in AKEA test,
* Right side lower extremity dominance

Exclusion Criteria:

* History of lower extremity injury in the last 12 months
* Having neurological or psychological problem
* Doing a stretching based exercise recently
* History of pain in the lower body and extremity in the Nordic Musculoskeletal Questionnaire
* Having lower extremity deformity
Cerebrovascular Response to Acute Exercise

Cerebrovascular function and peripheral vascular function will be measured in healthy young adults, before and after acute bouts of aerobic exercise at various intensities.

Acute bouts of aerobic exercise have been shown to enhance vascular reactivity of the peripheral circulation; however, the effects of a single exercise session on the cerebral circulation are unknown. This study will measure cerebrovascular function and peripheral vascular function before and after aerobic exercise at high and low intensities.

The research aims are:

1. To determine if a single bout of aerobic exercise acutely enhances cerebrovascular function
2. To determine the effect of aerobic exercise intensity and dose on cerebrovascular function in healthy adults.
3. To determine if the acute exercise-induced changes in cerebrovascular function are associated with acute exercise-induced changes in peripheral vascular function in healthy adults.

Eligibility Criteria:
Inclusion Criteria:

* Between 20-40 years old
* BMI \< 30 kg/m2
* Recreationally active
* Experience running on a treadmill

Exclusion Criteria:

* Current smoker
* History or evidence of: hepatic disease, renal disease, hematological disease, cardiovascular disease, stroke/neurovascular disease, diabetes
* Taking blood pressure medication
* History of depression or other mood related disorders
* Part of a vulnerable population (e.g. pregnant women, prisoner, individuals lacking capacity to consent, etc.)
Resistant Starch, Epigallocatechin Gallate and Chlorogenic Acid for Body Weight Loss in Menopause

For women aged between 55 and 65 years weight gain is a major health concern. Obesity is an important risk factor for multiple diseases (e.g. metabolic syndrome, diabetes mellitus, hypertension and cardiovascular disease), and several studies have shown that the transition to menopause is associated with adverse changes in body composition. In particular, it is common to observe the accumulation of adipose tissue in the abdominal region which is believed to be an important determinant of the increase in cardiovascular risk.

The first-line strategy for weight management in overweight / obese subjects is the modification of dietary habits and lifestyle in terms of physical activity. However, nowadays, there is also a growing interest in complementary therapies (i.e. herbal supplements, acupuncture, etc ...) that can be used alone or in combination to achieve more consistent results. In this context, preliminary evidence supports the potential role of some compounds of vegetal origin such as resistant starch, epigallocatechin gallate and chlorogenic acid as adjuvants of dietary therapy for overweight.

These nutrients may be an important therapeutic aid for overweight subjects. However, in support of their use, the evidence from good quality trials is limited.


Eligibility Criteria:
Inclusion Criteria:

* menopause of recent onset
* overweight (body mass index ≥ 25) or weight gain ≥ 10% after menopause
* written informed consent

Exclusion Criteria:

* use of Orlistat
* cancer diagnosis
* unavailability to planned measurements
Adolescent Digital Mental Health-Kenya Effectiveness

This study seeks to respond to the growing burden of adolescent mental health disorders and urgent preventive service needs in Kenya by studying the effectiveness of a digital health intervention- mobile health (mHealth) Toolkit for Screening \& Empowering Lives of Youth (mSELY)-that has demonstrated feasibility from our prior pilot study. The investigators will build on this work and examine two versions of mSELY. The mSELY-A is designed for adolescents to self-evaluate and manage psychological wellbeing/mental health needs, as well as to gain resources and access and connect with adolescent peers. The mSELY-P is designed for parents to self-evaluate their adolescent's development and mental health, gain awareness about their adolescent's mental health status, and learn strategies and resources to support adolescents' mental health. Both versions provide screening, tailored mental health literacy materials, and decision support for adolescents and/or their parents. This study will examine the effectiveness of these digital interventions using a randomized control trial with diverse community-based organizations in Kenya. In addition, the investigators will study underlying mechanisms that contribute to intervention effectiveness, as well as to use the data for precision medicine analysis (using machine learning approach). Findings will be used to improve Digital-Toolkit decision support functions and accuracy of mental health precision care.


Eligibility Criteria:
Adult parent and adolescent child will be enrolled in this study as a family.

Inclusion Criteria:

* Parent is over 18 years of age
* Parent has as an adolescent child between 11-14 years of age who attend one of our partnering schools/community-based organizations (CBOs).
* Parent is willing and able to provide consent for themselves and provide assent for their child
* Adolescent is between 11-14 years in age who attend one of our partnering schools/CBOs.
* One of adolescents adult parent (\>18 years old) is "interested in" participating in this study
* Adolescent is willing and able to provide child assent

Exclusion Criteria:

* Parents (including biological and non-biological) who have no contact with adolescents for over 1 month
Safety of LBH589 Alone and in Combination With Intravenous Docetaxel and Prednisone

This 2-arm study is designed to determine the maximum tolerated dose of LBH589 as a single agent and in combination with docetaxel and prednisone 5 mg twice daily (second arm) and to characterize the safety, tolerability, biologic activity and pharmacokinetic profile.


Eligibility Criteria:
Inclusion Criteria:

* Patients with hormone refractory prostate cancer
* Patients must have metastatic disease with at least 1 measurable soft tissue lesion that can be assessed by CT or MRI and/or detectable lesion(s) on bone scintigraphy scan. Patients with only elevated PSA levels are not eligible for entry.
* Patients must meet laboratory inclusion criteria defined in the protocol
* Patients must be able to provide written informed consent

Exclusion Criteria:

* Patients with prior or concurrent brain metastases
* Impaired cardiac, gastrointestinal, kidney or liver function
* Use of therapeutic androgens Other protocol-defined inclusion/exclusion criteria may apply
Health and Quality of Life One Year After Discharge From the Intensive Care Unit (ICU)

The goal is to capture the Quality of life and survival of patients one year after the stay at ICU. Data will be collected during the stay in the ICU and evaluated. One year after the ICU stay patients will be send a Quality of Life questionnaire they need to fill out and return. All data will be evaluated together.

no detailled description necessary

Eligibility Criteria:
Inclusion Criteria:

* patients who are at least 5 days or longer without interruption at the ICU

Exclusion Criteria:

* patients with less than 4 days at the ICU
Modality of Pain Management in Ambulatory Tonsillectomy Surgery in Adults

No SFORL recommendation for adult ambulatory tonsillectomy. This study would allow the establishment of an ambulatory management during an adult tonsillectomy. This would allow a return home from J0 for the patient and therefore would improve the comfort of the patients and reduce the cost associated with a conventional hospitalization over several days.


Eligibility Criteria:
Inclusion Criteria:

* programmed Tonsillectomy surgery

Exclusion Criteria:

* Congenital or acquired hemostasis disorder
* Indication of uvulo-bike-pharyngo-plasty
* Contraindication to the use of one of the protocol molecules including pregnancy
* Allergy to analgesic treatments used in the study
* Ongoing analgesic treatment that cannot be interrupted
Sitagliptin Dose Comparison Study in Patients With Type 2 Diabetes (MK-0431-077)(COMPLETED)

A study to assess the safety and efficacy of sitagliptin 100mg compared to sitagliptin 200mg in patients with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Patient has Type 2 Diabetes
* Patient is between the ages of 30-65 years
* Patient is not on an antihyperglycemic agent (AHA) (glycosylated hemoglobin \[A1C\] 7-10% ), or is on oral single AHA or low-dose combination therapy (A1C 6.5-9.5%).

Exclusion Criteria:

* Patient has Type 1 Diabetes
* Patient has been treated with sitagliptin, vildagliptin, or other similar drugs or has been treated with exenatide in the past 3 months
* Patient has taken insulin within the past 3 months
GreenLight Laser Photoselective Vaporization of the Prostate vs Bipolar Transurethral Vaporization of the Prostate; RCT

With a growing body of knowledge on the promising advancements and recent clinical data of the third generations of the Greenlight PVP/XPS, it seems to be a real contender in the world of MIS. Contenders of Greenlight laser technology includes bipolar as well as Holmium laser technology.

In this study the investigators planned to test the Greenlight (532-nm) laser PVP using (XPS) 180W system compared to bipolar electro-vaporization, in reduction of LUTS secondary to small to moderate sized BPH in a prospective randomized trial.

Patients with LUTS due to BPH seen through the outpatient prostate clinic in the Mansoura UNC were assessed to evaluate if the patient is eligible to the study inclusion criteria. Patients who are meeting these criteria were asked to participate in this randomized comparative study and were provided with an informed consent form. Study participants were enrolled and randomized, and the appropriate scheduled procedures were performed.

Preoperatively, all patients were thoroughly evaluated by medical history and physical exam, digital rectal exam (DRE), prostate specific antigen (PSA), urinalysis and urine culture, international index of prostate symptom score (IPSS), Quality of Life (QOL), transrectal ultrasound (TRUS) measurement of prostatic volume and biopsy whenever indicated, measurement of post-void residual assessment (PVR), and maximum urinary flow rate (Qmax). Preoperative flexible urethrocystoscopy was done when hematuria was the presenting symptom.

Eligibility Criteria:
Inclusion Criteria:

1. Patients' age ≥50 years
2. LUTS secondary to BOO due to BPH who failed medical treatment
3. International prostate symptom scores (IPSS) \>15 and bother score (QOL) ≥ 3 (according to IPSS question 8)
4. Peak urinary flow rate (Qmax) \<15 ml/sec with at least 125 ml voided volume or Patients with acute urine retention secondary to BPH who failed trial of voiding on medical treatment.
5. ASA (American society of anaesthesiologists) score ≤3.
6. TRUS prostate size (from 30 to 80ml)

Exclusion Criteria:

1. Patient with neurological disorder which might affect bladder function as cerebrovascular stroke, Parkinson disease
2. Active urinary tract infection,
3. Presence of active bladder cancer (within the last 2 years)
4. Known prostate cancer patients will be excluded preoperatively on the basis of digital rectal examination, prostate specific antigen level, and TRUS imaging followed by prostate biopsies if necessary.
Importance of Liver Innervation for the Osmopressor Response in Humans

In patients with autonomic dysfunction water drinking elicits a pressor response mediated by sympathetic activation. If any, in healthy subjects there is only a slight increase in blood pressure. However, the sympathetic activation is observable by resting energy expenditure increases greater than 20%.

The investigators believe that the response to water may be mediated through sympathetic activation elicited by osmosensitve spinal afferents in the liver. Therefore, the investigators want to test water in liver transplant patients who have a denervated liver. Kidney transplant patients serve as control subjects. The investigators hypothesize that the increase in norepinephrine after water drinking is blunted in liver transplant recipients.


Eligibility Criteria:
Inclusion Criteria:

* 3 to 24 month past liver or kidney transplantation
* age 18 to 60
* written informed consent
* ability to understand the oral and written information

Exclusion Criteria:

* pregnancy or lactation
* transplantation of another organ
* chronic heart or vascular disease
* known alcohol or drug abuse
* psychiatric diseases (e.g. chronic depression, schizophrenia, drug addiction)
Validity of a Home Respiratory Polygraphy for the Diagnosis of Obstructive Sleep Apnea

To assess the diagnostic validity and cost-effectiveness of a APNiA device, a home respiratory polygraphy (HRP).

To assess the diagnostic validity and cost-effectiveness of a APNiA device, a home respiratory polygraphy (HRP), performed at home compared with the standard polysomnography (PSG) in adults with clinically suspected Obstructive Sleep Apnea (OSA).

METHODOLOGY: DESIGN: Randomized, prospective, multicenter, and crossover trial. The study will include 240 adults, both sexes, with clinical suspicion of obstructive sleep apnea (OSA). MEASUREMENTS: To all patients with clinical suspected OSA and referred to the sleep units, the following questionnaires and measurements will be performed: a) clinical history; b) Anthropometric variables: weight, height, body mass index, neck circumference and percentile; c)Epworth sleepiness scale; OSA questionnaire, quality of life and clinical questionnaires and comorbidity; d) PSG in the sleep laboratory; e) HRP at home; f) Cost-effectiveness variables.

ANALYSIS: Data from HRP and from full PSG will be compared as follows: 1) Agreement of results according to the different apnea-hypopnea index by using the Receiver Operating Characteristic (ROC) curve; 2) The concordance of the diagnosis and treatment decisions when using clinical findings and data from PSG or HRP at home; 3) All data will be analyzed independently; 4) A cost-effectiveness analysis of the different diagnostic and therapeutic procedures will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Men and women over 18 years to 75 years old, with clinical suspicion of OSA
* Written informed consent signed

Exclusion Criteria:

* Psycho-Physical inability to perform the study at home
* Presence of insomnia or depressive syndrome
* Patient with malformation syndromes, Down syndrome and neuromuscular diseases
* Cardiovascular, cerebrovascular or respiratory disease exacerbated.
* Previous Positive continuous pressure (CPAP ) treatment or surgery for OSA
11C-Methionine PET/CT Imaging in Patients Affected by Malignant Pleural Mesothelioma (MPM)

Prospective exploratory study specifically investigating the role of 11C-Methionine PET/CT imaging in patients affected by Malignant Pleural Mesothelioma (MPM) and candidate to pleurodesis.

This is a single-center, open-label study, lasting 36 months including an estimated period of 24 months for the enrollment and max 12 months of follow-up. All patients affected by MPM and referred to our Institution eligible for therapeutic pleurodesis and subsequent platinum- and pemetrexed-based chemotherapy will be enrolled. In all cases patients will be investigated with 11C-Methionine PET/CT and 18F-FDG PET/CT before talc pleurodesis, one week after and at the end of three cycles of chemotherapy.

A minimum number of 20 patients will be considered for the analysis.

Eligibility Criteria:
Inclusion Criteria:

* patients with an histological diagnosis of MPM eligible for pleurodesis and scheduled to undergo platinum- and pemetrexed-based chemotherapy.
* obtained informed consent

Exclusion Criteria:

* patients age \<18 years
* pregnancy or breast-feeding;
* patients affected by other malignancies within the last 3 years;