cyrilzakka/clinical-trials huggingface dataset:
Nutritional Problems in Pallative Cancer

The aim of this study is to investigate those nutritional problems contributing to loss of lean body mass in lung and pancreas cancer patients in chemotherapy. Furthermore to investigate alterations in taste and how they correlates with changes in following factors: nutritional intake, physical activity, appetite, food preferences, side effects, fatique and meal perception.

This study will include a recruitment of 50 lung and pancreas cancer patients currently in chemotherapy. They will be observed during a period of 9-12 week, including at least 2 chemotherapy treatments. The presence and severity of the nutritional problems will be examined by observing as many different factors as possible. This includes taste alterations, weight changes, nutritional intake, physical activity, interviews and weekly questionnaires. In relation to this our primary outcome is to investigate the correlation between changes in taste and changes in nutritional intake. Secondarily the investigators want to investigate nutritional intake, physical activity, appetite, food preferences, side effects, fatique and meal perception.

Eligibility Criteria:
Inclusion Criteria:

* Lung or pancreas cancer patient
* In chemoterapy regardless of line treatment with/without combined treatment
* Legal age
* Able to speak and read in danish
* Ambulant

Exclusion Criteria:

* Inability to give consent and complete questionnaires
* Participating in clinical interventions during the periode of observation
* Allergic to milk or for any reason don't consume diary products
18F-FES PET/CT in Imaging Patients With Desmoid Tumors

This pilot clinical trial studies fluorine (F)-18 16 alpha-fluoroestradiol (18F-FES) positron emission tomography (PET)/computed tomography (CT) in imaging patients with desmoid tumors. 18F-FES binds to estrogen receptors, which are present on desmoid tumors, and gives off radiation that may be detected by PET and CT scans. The PET/CT scan forms an image that may show where tumor cells with estrogen receptors can be found in the body.

PRIMARY OBJECTIVES:

I. Establish the avidity of desmoid tumors on 18F-FES PET/CT imaging. II. Correlate 18F-FES PET avidity with degree of estrogen receptor (ER) expression by immunohistochemistry (IHC).

OUTLINE:

Patients undergo 18F-FES PET/CT imaging over 30 minutes.

After completion of study, patients are followed up for 30 days.

Eligibility Criteria:
Inclusion Criteria:

* Patients with biopsy-proven extra-abdominal desmoid tumors
* Not currently on estrogen medication for birth control, menopause, or other reason
* No anti-estrogen therapy for desmoid tumor within the past 6 months
* Both sporadic desmoid tumors and those associated with familial adenomatous polyposis (FAP) syndromes will be included

Exclusion Criteria:

* Pregnancy or nursing patients
* Patients who do not wish to participate
Thrombophilia and Migraine, Are They Related?

Migraine was described as related to stroke in adults and children as well. Complete thrombophilic status was not study in large groups of pediatric patients. The purpose of our study is to assess the prethrombotic profile among children and teenagers diagnosed as suffering from migraine attacks.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed as suffering from migraine according to the Neurologic criteria.
Atorvastatin and Sympathetic Activity in Chronic Kidney Disease

Hypertensive chronic kidney disease (CKD) patients often have sympathetic hyperactivity which appears to contribute to the pathogenesis of hypertension and cardiovascular organ damage. Experimental studies and some clinical studies have shown that statin therapy can reduce central sympathetic activity. Blockade of the renin-angiotensin system (RAS), which is standard treatment for CKD, is known to lower sympathetic activity.

The investigators hypothesize that adding a statin for 6 weeks to RAS blockade would further lower sympathetic activity in hypertensive stage 2-4 CKD patients.

Methods: In ten stable CKD patients who are on chronic treatment with renin-angiotenis blockers, blood pressure and sympathetic activity (quantified by assessment of muscle sympathetic nerve activity, MSNA) will be assessed at baseline and 6 weeks after atorvastatin 20mg/day added.

Ten other CKD patients will serve as time control and will be studied twice with an interval of 6 weeks without any change in medication, to quantify within subject reproducibility.

see above

Eligibility Criteria:
Inclusion Criteria:

* stable chronic kidney disease
* Hypertension

Exclusion Criteria:

* renal replacement therapy
* pregnancy
* diabetes mellitus
Phase 1 Study to Evaluate the Safety and Tolerability of EO1404 in the Treatment of Corneal Edema

Single center, phase 1 study to evaluate the safety and tolerability of EO1404 in subjects with corneal edema secondary to pseudophakic bullous keratopathy or Fuch's endothelial dystrophy.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 21 years
2. Pseudophakic with a posterior chamber intraocular lens.
3. Symptomatic corneal edema associated with endothelial dysfunction which may be secondary to Fuchs corneal dystrophy or pseudophakic bullous keratopathy.

   a Symptoms including reduced vision and/or glare, and/or pain; subject may or may not have been on topical therapies such as 5% sodium chloride drops or prednisolone acetate 1% drops.

   b ETDRS-best corrected visual acuity worse than 20/63 on Snellen. c Central corneal thickness \< 2 mm by ultrasound pachymetry or OCT. d Subject must have progressed far enough in their clinical course to be considered a surgical candidate for full-thickness corneal transplantation or endothelial keratoplasty.
4. Subject must understand and sign the informed consent. If the subject's vision is impaired to the point where he/she cannot read the informed consent document, the document will be read to the subject in their maternal language.
5. Subject must be medically able and willing to undergo the protocol-required procedures.

Exclusion Criteria:

All ocular criteria apply to study eye unless otherwise noted.

1. Other corneal disease, including active or prior herpetic ocular infection; active inflammation; corneal scarring from trauma, burns, or infection; or band keratopathy.
2. Visual acuity in the fellow eye is worse than 20/200.
3. Anterior chamber intraocular lens.
4. Subject requires topical, intravenous or oral acyclovir and/or related products during study duration
5. History of vitrectomy.
6. History of refractive surgery.
7. Macular disease that in the investigator and/or sponsor's opinion would limit the ability of the subject to demonstrate improvement in BCVA.
8. Prior incisional eye surgery within 3 months prior to study treatment.
9. Subject is receiving systemic steroids or other systemic immunosuppressive medications.
10. Subject is currently participating in or has participated within the last 3 months in any other clinical trial of an investigational drug by ocular or systemic administration.
11. History of uveitis or other ocular inflammatory disease.
12. History of glaucoma, or peripheral anterior synechiae on gonioscopy.
13. History of incisional glaucoma surgery (e.g., trabeculectomy, glaucoma drainage implant).
14. Female subject who is pregnant, nursing, or planning to become pregnant, or who is of childbearing potential and not using a reliable means of contraception during the study.
15. Subject is immunodeficient, or tested positive for HIV.
16. Subject is on chemotherapy.
17. History of malignancy other than basal cell carcinoma, UNLESS the malignancy was treated successfully 5 years prior to inclusion in the study.
18. History of ocular neoplasm.
Hydroxyephedrine PET/CT in Sympathetic Nervous System Disease

To evaluate the potential usefulness of 11C/18F-HED positron emission tomography/ computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions in various Tau-related disease patients.

Subjects with various sympathetic nerves-related disease patients underwent 11C/18F-HED PET/CT either for an initial assessment or for recurrence detection. Lesions uptake was quantified by the maximum standard uptake value (SUVmax). The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of 11C/18F-HED PET/CT were calculated.

Eligibility Criteria:
Inclusion Criteria:

* (i) adult patients (aged 18 years or order); (ii) patients with suspected or new diagnosed or previously treated malignant tumors (supporting evidence may include MRI, CT, tumor markers and pathology report); (iii) patients who had scheduled HED PET/CT scan; (iv) patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.

Exclusion Criteria:

* (i) patients with non-malignant lesions; (ii) patients with pregnancy; (iii) the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.
Visual Erotica, EMG, and Sexual Psychophysiological Arousal (VESPA)

This study will examine whether measurement of pelvic floor muscle sEMG activity is responsive to explicit sexual stimuli, and whether it correlates with self-reports of sexual arousal in healthy women. Participants' vaginal, labial and anal sEMG readings will be monitored during exposure to neutral, erotic and anxiety-provoking films. Participants will also be required to provide subjective ratings of sexual arousal before and after each film. If pelvic floor sEMG is validated as a psychophysiological measure, these findings may have important clinical and research implications by providing a greater understanding of the mechanisms involved in sexual arousal and for providing a relatively easy method of assessing sexual arousal in a clinical or research setting.

HYPOTHESES:

1. Investigators hypothesize that, relative to the neutral films, PFM EMG activity will significantly increase in response to the erotic film as measured by the labial, anal, and vaginal EMG probes.
2. Investigators hypothesize that, relative to the anxiety-provoking film, PFM EMG activity will significantly increase in response to the erotic film as measured by the labial, anal, and vaginal EMG probes.
3. Investigators hypothesize that continuously measured subjective sexual arousal (via the arousometer) will correlate significantly with PFM EMG activity during the erotic film.

Eligibility Criteria:
Inclusion Criteria:

* Must be female, between the ages of 19-45
* Must be premenopausal
* Must be previously sexually active
* Must be fluent in English

Exclusion Criteria:

* Lack of fluency in English
* Not female between the ages of 19-45
* Not previously sexually active
* Any previous deliveries, either vaginal or by c-section
* Any sexual arousal disorder
* Any genital pain or pelvic pain disorders
* Any bowel or bladder syndromes (e.g. interstitial cystitis, irritable bowel disease, Chron's disease)
* Any urinary incontinence or pelvic organ prolapse
* Undergone medically induced menopause
* Undergone total or partial hysterectomy
* Undergone surgery for incontinence or prolapse
* Using estrogen suppression medication
Assessing Pain in the Postoperative Period by Automatically Measuring the Variation Coefficient of Pupillary Diameter: PREVANS Study

Different pain assessment methods have been proposed to evaluate analgesic efficacy after surgical operation. Pain is a subjective phenomenon. Patient did his pain self assessment. But, cooperation of the patient is limited by cultural differences, language barriers or residual effect of products used while general anesthesia.

A lot of study were conducted to demonstrate and to quantify the pain after an operation. The aim will be dose analgesic treatment better without cooperation of the patient.

This sudy concerns patients on the post anesthesia care units one hour after their arrival. They will have electrocardiogram and video-pupillometer.

Primary objective is to compare Variation Coefficient of Pupillary Diameter (VCPD) obtained during a light flash and pain assessment realized thanks to Visual Analog Scale (VAS). Too, Variation Coefficient of Pupillary Diameter (VCPD) with electrocardiogram will be measured to demonstrate a correlation between the three parameters.

Eligibility Criteria:
Inclusion Criteria:

* Major patients
* Patients fluent in French
* Patient admitted on the post anesthesia care units

Exclusion criteria:

* Patients operated for all types of surgery except for heart, intra-cerebral, and ophthalmologic surgeries
* Emergency operation
* Heart rhythm disorders
* Pacemaker
A Study to Evaluate Pharmacokinetics (PK) and Safety of Inaxaplin in Participants With Renal Impairment

The purpose of this study is to evaluate the pharmacokinetics and safety of a single dose of Inaxaplin (IXP) in participants with severe renal impairment and healthy participants with normal renal function.

This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).

Eligibility Criteria:
Key Inclusion Criteria:

* Body mass index (BMI) of 18.5 to 40.0 kilogram per meter square (kg/m\^2)
* Stable renal function for at least 1 month prior to enrollment

Key Exclusion Criteria:

* Uncontrolled hypertension
* Any condition possibly affecting drug absorption

Other protocol defined Inclusion/Exclusion criteria may apply.
Study of Nitazoxanide in Adults With Acute Uncomplicated Influenza

This is a randomized clinical trial designed to evaluate oral nitazoxanide compared to a placebo in the treatment of acute uncomplicated influenza in adults. We hypothesize that treatment with nitazoxanide will reduce the duration of symptoms in patients with confirmed influenza infection. Secondarily, we hypothesize that treatment with nitazoxanide will reduce the complications of influenza, severity of symptoms, time lost from work, time to return to normal daily activities, and viral shedding.

The study is conducted at approximately 25 sites in the United States. Subjects selected based on symptoms will be randomized to receive oral nitazoxanide or placebo twice daily for 5 days. Subjects will be monitored by daily by telephone or home visit to monitor symptoms and complications of influenza for safety and will be referred for medical care as required. Subjects will complete a diary twice daily to record the presence and severity of symptoms, ability to perform normal daily activities and time lost from work. Complications of influenza (including sinusitis, otitis, bronchitis, pneumonia, central nervous system disease) and other adverse events will be reported. Nasopharyngeal swabs will be collected at Baseline (Day 0) and Day 7 for all patients and on Days 1 through 4 for a subset of patients to test for influenza A (including novel H1N1), influenza B and 17 other respiratory viruses by RT-PCR and culture and to evaluate quantitative viral shedding. The primary analysis will be for patients with confirmed influenza, and secondary analyses will be conducted for subjects with any respiratory virus and for all treated subjects.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 65 years
* Fever, respiratory symptoms and constitutional symptoms compatible with influenza infection
* Influenza A or B infection in the local community
* Onset of illness no more than 48 hours before presentation
* Willing and able to provide comply with protocol requirements

Exclusion Criteria:

* Severity of illness requiring or anticipated to require in-hospital care
* High risk of complications from influenza per IDSA (Infectious Diseases Society of America) guidelines or current CDC (Centers for Disease Control) criteria
* Females pregnant, breast-feeding or sexually active without birth control
* Vaccination for seasonal influenza or H1N1 on or after August 1, 2009
* Treatment with antiviral medication for influenza within 1 month prior to screening
* Treatment with nitazoxanide or any investigational drug within 1 month prior to screening
* Known sensitivity to nitazoxanide or any excipients
* Unable to take oral medications
* Chronic kidney or liver disease or known impaired hepatic and/or renal function
* Other pre-existing chronic infection undergoing or requiring medical therapy
* Pre-existing illness placing subject at unreasonably increased risk by participation in study
* Unlikely to comply with the requirements of this protocol
Identification of Genes Associated With Lung Disease in Patients With Rheumatoid Arthritis

Pulmonary fibrosis (PF) is a condition in which the lungs of a patient become scarred and fibrous. It has been known to occur in as many as 40% of patients diagnosed with rheumatoid arthritis (RA). The cause of the pulmonary fibrosis in patients with RA is unknown.

Data gathered from previous research studies suggest that genetics may play a role in the development of PF in patients with rheumatoid arthritis. However, the actual genetic factors involved in the disease process have not been identified.

The goal of this study is to identify the genetic markers in patients with pulmonary fibrosis and rheumatoid arthritis.

Pulmonary fibrosis that develops within a subpopulation of patients with rheumatoid arthritis is a disorder of unknown etiology. Although previous reports suggest that some individuals with rheumatoid arthritis have a genetic predisposition to the development of fibrotic lung disease, genetic factors have not been clearly identified. It is the intent of this clinical protocol to identify genetic polymorphisms in individuals with pulmonary fibrosis and rheumatoid arthritis.

Eligibility Criteria:
* INCLUSION CRITERIA:

Individuals 21 years of age or older with any of the following:

RA (based on 1987 American College of Rheumatology Revised Criteria for the Classification of RA) with PF (biopsy-proven), or

RA-only, or

Biopsy-proven idiopathic PF-only, or

Healthy research volunteers.

EXCLUSION CRITERIA:

Individuals with any of the following:

Inhalational exposure to fibrogenic fibers or dusts (e.g., asbestos, silica, coal, beryllium).

Chronic pulmonary disorders other than pulmonary fibrosis.

Other collagen vascular disorders (e.g., systemic lupus erythematosus, scleroderma, polymyositis, mixed connective tissue disease).

Non-rheumatoid arthritis.

Viral infections associated with PF (e.g., hepatitis B, hepatitis C, human immunodeficiency virus).

Pregnancy.
Effects of Flapless Laser Corticotomy in Canine Retraction

This study is conducted to evaluate the effects of flapless laser corticotomy on the rate of canine retraction.


Eligibility Criteria:
Inclusion Criteria:

* Full complement of teeth with no congenitally missing teeth except 3rd molars.
* Minor or no crowding cases requires four premolars extraction, canine retraction \& maximum anchorage with bimaxillary dentoalveolar protrusion.
* No history of previous orthodontic treatment
* Clinically healthy patients with no history of drug intake and\\or no history for any systemic illness, syndromes, craniofacial deformities.
* Vital teeth with normal periodontium and no root resorption.
* Adequate oral hygiene; probing depth values not exceeding 3 mm across the entire dentition; adequate thickness of the attached gingiva (1-2 mm).
* No radiographic evidence of bone loss.

Exclusion Criteria:

* Systemic disease that might have affected bone formation or density, such as osteoporosis, hyperparathyroidism, or vitamin D deficiency.
* Presence of any local or systemic surgical contraindication.
* Extracted or missing permanent tooth/teeth except for 3rd molars.
* Facial asymmetry
Ultrasound-guided Nerve Blocks for the Sciatic and Saphenous Nerves: Characteristics of the Single Penetration Dual Injection (SPEDI) Technique

Background and aims: Ultrasound-guided (USG) nerve blocks of the sciatic nerve (popliteal level = PL) and the saphenous nerve (mid-femoral level = MFL) provides analgesia following leg surgery. Traditionally two separate injections are performed. The aim was to describe a novel, faster USG block combination requiring only one skin penetration to block the sciatic and saphenous nerves; i.e. the SPEDI block = Single PEnetration Dual Injection.

Methods: A randomized, controlled and double-blinded trial. Following ethics committee approval 60 patients will be randomized to the administration of an USG SPEDI block compared to two separate USG blocks of the saphenous (MFL) and sciatic (PL) nerves. Blocks will be performed after induction of general anaesthesia. Outcome measures will be performance time (primary outcome measure), Post-Anaesthesia Care Unit pain scores (VAS scores 0-10), block difficulty level (easy, middle, difficult), opioid consumption (in the PACU), serum-ropivacaine pharmacokinetics (blood sample 0-180 minutes). Both block combinations will be evaluated by MR imaging (MRI).

Hypothesis: The USG SPEDI block combination is expected to be performed significantly faster without moving the leg, and achieve successful perioperative pain management. The SPEDI block may find important use in the emergency setting.


Eligibility Criteria:
Inclusion Criteria:

* lower leg surgery
* American Society of Anesthesiologist (ASA) score I-III
* Can cooperate in the study
* Speaks and understand the Danish language
* General anesthesia

Exclusion Criteria:

* Intake of oral morphine above 40 mg per day
* Know allergy to ropivacaine
* Abuse of alcohol or other substance abuse
* Neuropathy
* Pregnant
* Nerve block contraindicated
Does the Menstrual Phase Affect Gastric Emptying? Prospective, Observational Study

This prospective observational study aimed to evaluate the relationship between menstrual phase cycles and gastric emptying in female volunteers of reproductive age.

Volunteers included in the study will be evaluated for gastric emptying with USG in both phases of the menstrual phase. In each phase, volunteers will be evaluated for gastric emptying of both liquid food intake and a light meal. At first, 400 ml of water will be drunk after 10 hours of fasting, and gastric content will be evaluated with USG after 2 hours.

Secondly, after 10 hours of fasting, solid food intake will be evaluated. Then, after taking a light meal (toast and 200 ml tea), the volunteers will be evaluated by USG at the 6th hour.

Eligibility Criteria:
Inclusion Criteria:

* Female volunteers of reproductive age have had a regular menstrual cycle for at least six months

Exclusion Criteria:

* Pregnancy
* Stomach problem
* Using anticholinergics, opioids, and oral contraceptive drugs
* Hypothyroidism
* Diabetes mellitus
* Smokers