cyrilzakka/clinical-trials huggingface dataset:
Fentanyl Sublingual Spray for the Treatment of Acute Procedure-related Pain in a Monitored Setting

Participants will be selected from patients who have been scheduled at the site for treatment of chronic pain without sedation. They will receive either fentanyl sublingual spray or a matching placebo sublingual spray that delivers no medication.

Participants may take pain killers at any time after the procedure for pain relief. They will be given a diary card, which they will take home. They will record the name of the medication taken, the time, and dosage.

The study coordinator will call participants about 24 hours after the procedure to collect information from the diary card and follow up information about pain and side effects (adverse events) after they left the site.

Participants will be separated into opioid-experienced and opioid-naïve groups. Participants in each group will be randomly allocated in a 3:1 ratio to receive fentanyl sublingual spray (FSS) or a matching placebo sublingual spray (PSS) 10 minutes before the scheduled procedure. Based on FDA guidelines, opioid-experienced FSS participants will receive FSS 400 µg, and opioid-naïve FSS participants will be further randomized in a 1:1 ratio to receive either 100 µg or 200 µg. All participants randomized to placebo receive the same matching PSS, regardless of opioid experience. Pain and sedation will be recorded multiple times during the scheduled procedure. If rescue medication is needed during the procedure, local anesthetic standard of care for the procedure will be administered and recorded in the study record. Efficacy and safety/tolerability of fentanyl sublingual spray will be evaluated among and between the treatment groups.

Eligibility Criteria:
Inclusion Criteria:

* Has scheduled an interventional procedure for treatment of pain without sedation
* Has cleared pre-operative assessment
* Is able to read or understand informed consent form, and gives consent to participate in the study

Exclusion Criteria:

* Is taking any form of fentanyl
* Has oral pathology that would prevent effective absorption of study medication
* Was treated with an investigational drug within protocol-specified parameters
* Has signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise: 1) the safety or well-being of the participant or study staff, 2) the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding), 3) the analysis of results
Parents' View About Discussing Health Behaviors

It is important to increase understanding of parent views about discussions of health risk behaviors with their children, in order to guide efforts to develop health communication strategies aimed at promoting parent and child discussion of these behaviors. In turn, this may lead to a decrease in youth engaging in health-risk behaviors. This study explores parental views about discussing health risk behaviors with their children and then tests the effects of a discussion tool on parents conversations with their children about unhealthy eating, marijuana use, and sedentary behavior. Participants will include parents living in the United States who have children ages 10 to 17 years old.

Adolescence is often characterized as a particularly difficult time for children. Though adolescents begin to desire independence from their parents, parents still play an integral role in prevention of health-risk behaviors in their children. In fact, the quality of the parent-child relationship continues to serve as a determining factor of whether or not an adolescent will engage in harmful behaviors. Often times, this may lead to the practice of risky and harmful behaviors, such as, poor diet, substance use, unprotected sex, and reckless driving. The quality of the parent-child relationship continues to serve as a determining factor of whether or not an adolescent will engage in harmful behaviors. For instance, weekly parent-child discussions have also been identified as one of the strongest factors in influencing healthier food choices in adolescents. It is important to increase understanding of parent views about discussions of health risk behaviors with their children, in order to guide efforts to develop health communication strategies aimed at promoting parent and child discussion of these behaviors. In turn, this may lead to a decrease in youth engaging in health-risk behaviors.

This study explores parental views about discussing health risk behaviors with their children and then tests the effects of a discussion tool on parents conversations with their children about unhealthy eating, marijuana use, and sedentary behavior. Participants will include parents living in the United States who have children ages 10 to 17 years old. The study will consist of a baseline survey, and then a follow-up survey four weeks later. Participants will be randomly assigned to one of three discussion tool conditions that include marijuana use, unhealthy eating, or sedentary behavior. One month later, participants will be invited to complete a follow-up survey that will measure discussion behavior, followed by items from the initial survey. Following the survey completion, participants will read a brief explanation of the study and receive links to websites of national health organizations with information about unhealthy eating and marijuana use.

Eligibility Criteria:
Inclusion Criteria:

* Parent of children ages 10 to 17 years old living in the United States.

Exclusion Criteria:

-
The Effect of Shelf Nutrition Labels on Purchases

NuVal® shelf nutrition labels rate the nutritional quality of foods on a scale of 1 (worst) to 100 (best). In 2014, NuVal updated their nutrient profiling system which changed the NuVal score on many foods. The investigators took advantage of this "natural experiment" to assess the extent to which a change in the NuVal score at a grocery chain influenced yogurt purchases, a category with a wide range of more and less healthy alternatives. The investigators supplemented the retail scanner data with a survey of consumers in stores using NuVal labels to obtain their experience with the labels and the extent to which they state it influences their purchases.


Eligibility Criteria:
Inclusion Criteria:

* US adults regularly shopping at one of two retail chains using NuVal

Exclusion Criteria:

-
A Study Evaluating Efruxifermin in Subjects With Compensated Cirrhosis Due to NASH/MASH

This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study in subjects with compensated cirrhosis due to NASH/MASH.


Eligibility Criteria:
Inclusion Criteria:

* Cohort 1: Biopsy proven compensated cirrhosis (fibrosis stage 4) due to NASH/MASH
* Cohort 2: Biopsy proven or non-invasively diagnosed compensated cirrhosis (fibrosis stage 4) due to NASH/MASH

Exclusion Criteria:

* Other causes of liver disease based on medical history and/or liver histology and/or central laboratory results
* Type 1 diabetes or unstable Type 2 diabetes
* Any current or prior history of decompensated liver disease

Other inclusion and exclusion criteria may apply
Prophylactic Bilateral Salpingectomy and Laparoscopic Myomectomy

We already demonstrated that the addiction of PBS to Total Laparoscopic Hysterectomy (TLH) has no negative effects in term of ovarian function, evaluated by anti-Müllerian hormone (AMH), Follicle Stimulating Hormone (FSH), Antral Follicle Count (AFC), mean ovarian diameters and Peak Systolic Velocity (PSV). In addition, in our experience, no negative surgical outcomes (in terms of operative time, intraoperative blood loss, postoperative hospital stay, postoperative return to normal activity and complication rate) are related to PBS step in TLH.

Although the good statistical reliability of our retrospective data, we want to prospectively confirm our results. Moreover we aim to refine PBS safety demonstration by collecting also 3D ultrasound parameters \[AFC, ovarian volume (OV), Vascularization Index (VI), Flow Index (FI) and Vascularization Flow Index (VFI)\]. Hormonal and ultrasonographic parameters may possibly be unified into a new diagnostic algorithm (already at an advanced stage of production in UMG Department) able to estimate the ovarian function both in term of reproductive ability that in term of distance from menopause.

We will enroll the first 77 patients who will agree to implement PBS to laparoscopic myomectomy (LM) (study group), starting from September 1, 2013. Other 77 patients who will ask us to undergo LM without the addiction of PBS will constitute the control group. For each patient, ovarian reserve modification before and after surgery will be recorded as the primary outcome. Specifically, one month before and three months after laparoscopy, on day 1 to 4 of menstrual cycles serum AMH, FSH and E2 will be evaluated and a transvaginal ultrasound examination (Voluson E8 Expert or Voluson-i - GE Healthcare Ultrasound) to assess AFC, OV, VI, FI and VFI, will be carried out by the same experienced ultrasonographist responsible for the ambulatory of ovarian reserve in each Unit.

Ovarian reserve modification will be defined as the difference (expressed as Δ) between post-operative and pre-operative values of AMH, FSH, AFC, OV, VI, FI and VFI. For each surgical procedure, moreover, operative time, variation of hemoglobin level, postoperative hospital stay, postoperative return to normal activity and complication rate will be recorded as secondary outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Indication to laparoscopic myomectomy
* Accomplished reproductive desire

Exclusion Criteria:

* Age older than 50 years
* family history of ovarian cancer, BRCA positive
* basal FSH value of \>20 IU/mL and/or E2 levels \>60 pg/mL
* presence of menopausal symptoms,irregular (cycle-to-cycle variation over 12 months \>20 days orpresence of any breakthrough bleeding) menstrual cycles, hormonereplacement treatment and/or hormonal contraception for the last 3 months, history of previous uterine or ovarian surgeries, and imaging suggestive of ovarian cyst or tubal pathology at transvaginal ultrasound.
Effect of Etomidate and Propofol on Electroencephalography

Electroencephalography (EEG) monitoring reflect the brain electro-activity. Different anesthetics may show different changes in EEG during anesthesia. Etomidate and propofol are widely used for general anesthesia. The characteristic changes of these two anesthetics may be different.


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for surgery under general anesthesia
* Patients provided written informed consent

Exclusion Criteria:

* Patients with history of neurological or psychiatric diseases
* Patients younger than 18 years old
* Patients scheduled for surgery involved head
* Patients with pregnancy or planned for breeding
Can Brief Exposure to Hyperoxia Improve Function After Chronic Spinal Cord Injury?

This proof-of-principle study will determine if breathing an increased concentration of oxygen above the concentration in normal room air results in changes in the sensory and motor function in people with subacute or chronic, severe spinal cord injury (SCI).

This proof-of-principle study will include a small number of participants with subacute or chronic (\>3 months post-injury), severe spinal cord injury (i.e., AIS A, B or C). After screening for potential contraindications, participants will attend 4 experimental sessions. In each session, their sensory or reflex function will be tested at regular intervals. Once baseline recordings are established, participants will be given either room air or 99% oxygen to breathe through a face mask for 2 minutes. It will be determined if breathing 99% oxygen results in a change in the sensory and motor functions recorded before and shortly after breathing oxygen.

Administration of a high concentration of oxygen at atmospheric pressure for a short duration has been completed without adverse effects in healthy individuals, and individuals with various forms of injury including chronic obstructive lung disease, traumatic brain injury, stroke, and spinal cord injury. Duration of administration has ranged from 3 min to 4 hours without adverse effects.

If this initial trial indicates that improvements in sensory and motor function are induced by this short exposure, exploration of therapeutic ways to increase blood flow to the spinal cord will be undertaken

Eligibility Criteria:
Inclusion Criteria:

1. Individuals with traumatic SCI with onset ≥3 months prior,
2. Between 18 - 65 yr old,
3. ASIA Impairment Scale at discharge classified as A, B or C,
4. Injury level between C5 and T10,
5. Able to give informed, written consent.

Exclusion Criteria:

1. Frequent uncontrolled autonomic dysreflexia,
2. Uncontrolled high blood pressure,
3. Cardiac or cardiovascular disease,
4. Cancer,
5. Active urinary tract infection,
6. Active pressure sores,
7. Signs of deep vein thrombosis in the legs,
8. Severe swelling of the feet and/or legs,
9. Severe cognitive impairment,
10. Pulmonary dysfunction such as chronic obstructive pulmonary disease or acute respiratory infection,
11. Any condition which would be exacerbated by sitting or lying in one position for 2 hours, such as low back pain
12. Pregnancy.
Effect of Diabetes on Short İmplants in One- and Two-Stage Surgeries

The goal of this clinical trial is to compare one- and two-stage techniques for short implant surgery in diabetes. The main questions it aims to answer are:

* Is one-stage short implant surgery at risk of implant osseointegration in diabetic patients compared to two-stage surgery?
* Is one-stage short implant surgery associated with a risk of implant survival (at one-year follow-up) in diabetic patients compared to two-stage surgery?
* What are the effects of one- and two-stage short implant surgery on the marginal bone loss or ISQ (implant stability coefficient - resonance frequency analysis device measurement) values of the implant in diabetic patients?

Participants will come for their 3rd, 6th and 12th month controls.

* Participants will receive two adjacent short implants.
* A randomly selected one of these short implants will undergo a one-stage implant surgery, and the other a two-stage implant surgery.
* Data will be obtained through non-invasive evaluation methods during the surgery and subsequent control stages.

Researchers will also test one- and two-stage short implant surgeries in a control group of healthy individuals. Thus, the effects of diabetes on these two techniques will be better understood by comparing them with the healthy control group.


Eligibility Criteria:
Inclusion Criteria:

* The maxillary and mandibular posterior region (distal part of the canine in each quadrant) must have toothless space for two adjacent short implants.
* The edentulous space must have a vertical bone height of at least 5 mm. (Distance to maxillary sinus and alveolar nerve)
* The edentulous space should not require horizontal bone augmentation. (for implants with diameters 3.7 - 4.1 - 4.7 - 5.3)
* Bleeding on probing should be less than 10%. There should be no pathological pockets in any tooth.
* Participant should not smoke more than 10 cigarettes per day.
* More than 6 months must have passed since the tooth extraction from the edentulous area.
* Should not have bruxism
* If it is diabetes, the HbA1c value should be greater than 6.5, and if it is healthy control, the HbA1c value should be between 4 and 5.

Exclusion Criteria:

* Having psychological problems
* Smoking more than 10 cigarettes per day
* Pregnancy status if female patient
* Having a medication or disease that will cause abnormal post-operative bleeding
* Alcohol and drug use
Fluid Restriction After Stapled Hemorrhoidopexy

BACKGROUND: Conventional hemorrhoidectomy leads to a high urinary retention rate and fluid restriction is commonly recommended to minimize complications. However, the need for postoperative fluid restriction among patients who have undergone stapled hemorrhoidopexy is unclear. We aimed to determine whether fluid restriction after stapled hemorrhoidopexy with/without partial external hemorrhoidectomy could reduce urinary retention and postoperative pain.

PATIENTS AND METHODS: In this prospective, double-blinded, randomized controlled trial, we enrolled patients who had grade III or IV hemorrhoids and underwent stapled hemorrhoidopexy with/without partial external hemorrhoidectomy; 250 mL/12 h of sterile 0.9% saline was administered to the fluid restriction group after the operation, and 1000 mL/12 h was given to the non-fluid-restriction group. We focused on the need for fluid restriction after stapled hemorrhoidopexy.


Eligibility Criteria:
Inclusion Criteria:

* Gr. III-IV hemorrhoids paitents

Exclusion Criteria:

* Age\<20 or \>80
* Allergy to NSAID or opoids
* Impaired renal function
* Pregnant or breast feeding
Effects of Whole-Body Electromyostimulation on Golf Performance

Golf is becoming increasingly popular in Germany. However, the biomechanical and motor challenge of golf should not be underestimated. Nevertheless, only very few amateur golfers carry out serious preparation and conditioning as part of a strength/stabilization program. The main argument for this limitation is the aspect of "limited time resources". A solution to this problem could therefore be the time-effective and highly individualizable whole-body electromyostimulation (WB-EMS) technology. The aim of the present study is to evaluate the effectiveness of 16 weeks of WB-EMSapplication on maximum strength of the lower extremities, trunk stability and (golf) handicap in male amateur golfers in a (randomized) controlled setting.


Eligibility Criteria:
Inclusion Criteria:

* golf amateurs with a history if golf \> 2 years
* no WB-EMS application during the last 12 months

Exclusion Criteria:

* contraindications for WB-EMS (in doubt assessment by study physician)
* contraindications for MRI (in doubt assessment by study physician)
* resistance exercise training for more one 60 min/week during the last 12 months
* expected absence of more than one week during the intervention period (WB-EMS)
Development of a Smoking Cessation Video Series

This study seeks to develop and test an internet video series aimed at helping individuals reduce cigarette smoking. Participants (daily smokers) will be asked to watch a series of six videos (approximately 6.5 minutes each) which cover various empirically-supported smoking cessation strategies and tools. Examples of strategies included in the videos include noticing smoking cues and consequences and relaxation training. Participants' demographic information, motivation to change, reactions to the video series alliance with video therapist, and confidence in avoiding smoking will all be measured. Additionally, participants will be asked to report their smoking behavior at study baseline and follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Daily smoker
* Interested in reducing smoking
* Not currently enrolled in any smoking cessation program.

Exclusion Criteria:

* Not interested in reducing smoking
* Currently enrolled in a smoking cessation program.
A Study Comparing the Pharmacokinetics and Tolerance of D-Gam® to Rhophylac® in Rh-D-negative Healthy Volunteers.

The primary objective of the study was to compare peak serum anti-D levels (Cmax) of BPL's D-Gam® 1500 IU to Rhophylac® 1500IU in RhD-negative healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Females
* Ages of 18 and 55 years
* Bodyweight of 50-85kg.

Exclusion Criteria:

* Clinically relevant abnormalities at physical examination, ECG or laboratory tests.
A Phase I Trial of Simmitinib in Advanced Solid Tumors

This is an open label, multi-center, phase I study of oral Simmitinib in subjects with advanced solid tumors including gastric cancer.

This is an open label, multi-center, phase I study of oral Simmitinib in subjects with advanced solid tumors including gastric cancer \[including gastroesophageal cancer\], cholangiocarcinoma, lung squamous cell carcinoma, urothelial transitional cell carcinoma, and estrogen-receptor-positive breast cancer patients \[ER+\], etc. This phase I study will evaluate the safety, tolerability, pharmacokinetics and the preliminary efficacy of the FGFR/KDR/CSF1R multi-target inhibitor Simmitinib.

Eligibility Criteria:
Inclusion Criteria:

* Voluntary written informed consent of the patient obtained before any study-specific procedure；
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1;
* Patients with histologically/cytologically confirmed diagnosis of advanced solid tumors refractory to standard therapy or for whom no standard therapy exist;
* Adequate washing period from last anti-tumor therapy;
* Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1;
* The expected survival time for more than 12 weeks;
* Adequate bone marrow, hepatic, renal, pancreas, and coagulation function, Blood phosphorus and calcium in the normal range.

Exclusion Criteria:

* Prior treatment with selective FGFR inhibitors or multi-target kinase Inhibitors with FGFR as the main target;
* Unrecovered from any drug-related adverse event to grade ≤ 1 according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v.3.0 derived from any previous anti-tumor treatment, excluding alopecia, Pigmentation, or other toxicity with little safety risk for subjects;
* Active Central Nervous System (CNS) metastases (brain or leptomeningeal metastases, etc.);
* Any other history of malignancy within 3 years;
* Congenital coagulation abnormalities. Active bleeding or previous history of massive bleeding (\>30ml within 3 months), history of hemoptysis (more than 5ml fresh bleeding within 4 weeks);
* Corneal diseases of clinical significance. There is a history of retinal pigment epithelial detachment or evidence of the presence of retinal pigment epithelial detachment. History of age-related macular degeneration or evidence of age-related macular degeneration exists；
* Subjects with impaired cardiac function or heart disease of clinical significance;
* Pregnant or lactating women.
Rogaland Trauma System Study

The purpose of this study is to improve performance, Stavanger University Hospital (SUH) reorganized key system structures and introduced in 2009 mandatory documentation of field Revised Trauma Score on trauma patients, tiered trauma team activation and new guidelines for field triage. Through a before and after study, the investigators aim to measure how the quality improvement initiative will influence structure, process and outcomes variables.


Eligibility Criteria:
Inclusion Criteria:

* Included in trauma registry

Exclusion Criteria:

* Excluded from trauma registry
Desflurane in Children With Laryngeal Mask Airway

The purpose of this study is to characterize the airway responses to desflurane during maintenance of and emergence from anesthesia in children whose airways were supported with laryngeal mask airways (LMAs).


Eligibility Criteria:
Inclusion Criteria:

* scheduled for elective surgery under general anesthesia with laryngeal mask airway

Exclusion Criteria:

* history of reactive airways disease with an acute exacerbation within the past 2 weeks
* if wheezing or an active upper respiratory infection was present on the day of surgery
* if there was a history of malignant hyperthermia
* a history of moderate-to-severe hepatic dysfunction following anesthesia with desflurane not otherwise explained.