cyrilzakka/clinical-trials huggingface dataset:
A Safety and Effectiveness Study of JNJ-31001074 in Adults With Attention-Deficit/Hyperactivity Disorder.

The purpose of this study is to evaluate the safety and effectiveness of JNJ-31001074 compared to placebo in adults with Attention Deficit Hyperactivity Disorder (ADHD).

This study is being done to assess safety and tolerability and to explore the effectiveness of a new, experimental drug in the treatment of attention deficit hyperactivity disorder in adults. Approximately 144 adult patients with ADHD will be recruited for the study. Patients who meet study criteria will need to stop taking any ADHD medications they are currently using. They will be randomly assigned to one of 3 treatment arms; each patient has an equal chance of receiving 10 mg JNJ-31001017, 30 mg JNJ-31001074, or placebo. Placebo has no active drug. This is a blinded study, i.e. the patient, the study doctor and the study sponsor will not know what treatment the patient receives until all patients complete the study. Patients will be dispensed a bottle containing study drug for the upcoming week at 4 of the study visits. The study doctor and the sponsor will monitor the study for the occurrence of possible side effects. In addition to a screening visit, patients will return weekly for 6 additional study visits including an end of study visit and a follow-up visit. Patients will take study drug for a total of 4 weeks. After completing the study, patients may resume other ADHD medications. Medical and ADHD history, physical examination, blood pressure, heart rate, temperature, weight and ECGs will be checked periodically throughout the study. Blood samples will be taken for standard safety laboratory tests as well as for the measurement of the drug blood level. Questionnaires relating to ADHD and cognitive testing will be administered throughout the study. Each day for four weeks, patients will take orally, at least one hour before eating in the morning, 1 tablet containing either 10 mg JNJ-31001074, 30 mg JNJ-31001074 or placebo.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of attention deficit hyperactivity disorder with symptoms from age 7
* In good general health
* Willing to not take any other ADHD medication or start any behaviorial modification programs during the study
* Willing to use approved birth control throughout the study and for 3 months afterwards

Exclusion Criteria:

* Any psychiatric condition including acute mood disorder, bipolar disorder, acute obsessive-compulsive disorder (OCD), anti-social personality disorder or borderline personality disorder
* Autism, asperger's syndrome, mental retardation
* Presence of motor tics, history of Tourette's syndrome or family history of Tourette's syndrome
* History of substance use/abuse disorder or eating disorder
* History of myocardial infarction, stroke, glaucoma, seizures, hypertension, heart rhythm abnormalities or color blindness
* Use of prescription medication or herbal supplements
The Role of BEMER and Kinesiotape in Increasing the Effectiveness of Physiotherapy and Rehabilitation Program After Videothoracoscopy Surgery

The literature indicates that postoperative pulmonary complications are seen when pain is not treated effectively after videothoracoscopy surgery (VATS). After surgery, physiotherapy and rehabilitation approaches are applied to prevent complications. Bio-Electro-Magnetic-Energy-Regulation (BEMER) therapy uses low-frequency electromagnetic energy to regulate vasomotion in capillaries and increase microcirculation. BEMER therapy can be applied together with physiotherapy and rehabilitation. The aim of this study is to investigate the effectiveness of BEMER application, which is added to the physiotherapy and rehabilitation program applied after videothoracoscopy surgery.


Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria for the study were to have undergone VATS lobectomy and to be aged between 18 and 75 years.

Exclusion Criteria:

* Presence of pacemaker, severe cardiac failure, severe arrhythmia
* Those with cooperative disorders
* Presence of neurological or orthopedic problems affecting the extremities
* Those with severe psychiatric disorders
* Failure to perform the operation according to the result of intraoperative tumor staging
* Patients who go out of the standard Analgesia protocol
* Patients who were taken back from the service to the intensive care unit
Platelet Rich Fibrin in the Treatment of Full Thickness Palatal Wounds

In this study it will be investigated the usefulness of Platelet-Rich Fibrin (PRF) on in the full thickness palatal graft donor site healing acceleration and in the patient's morbidity reduction. Eighty patients, with at least one gingival recession will be treated by a flap with connective tissue graft(CTG). In the test group (20 patients) and in the control group 2 a quadruple layer of PRF membrane will be placed over the palatal wounds; conversely, the control groups 2-4 patients will be treated by an absorbable gelatin sponge. Patients will be monitored at 1, 2, 3 and 4 weeks after surgery for the complete re-epithelialization of the palatal wound (CWE), the alteration of sensibility (AS) around the wound area, the post-operative discomfort (D), and the changes of feeding habits (CFH) by a visual analogic scale (VAS) evaluation. Furthermore, the analgesics consumption and the existence of delayed bleeding from the palatal wound (DWB) during the first post-operative week will be assessed.

In this study it will be investigated the usefulness of Platelet-Rich Fibrin (PRF) on in the full thickness palatal graft donor site healing acceleration and in the patient's morbidity reduction. Eighty patients, with at least one gingival recession will be treated by a coronally advanced flap (CAF) with connective tissue graft(CTG) resulting from the de-epithelialization of a free gingival graft. In the test group (20 patients) a quadruple layer of PRF membrane will be placed over the palatal wounds; conversely, the control groups patients will be treated by an absorbable gelatin sponge. Patients will be monitored at 1, 2, 3 and 4 weeks after surgery for the complete re-epithelialization of the palatal wound (CWE), the alteration of sensibility (AS) around the wound area, the post-operative discomfort (D), and the changes of feeding habits (CFH) by a visual analogic scale (VAS) evaluation. Furthermore, the analgesics consumption and the existence of delayed bleeding from the palatal wound (DWB) during the first post-operative week will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* to have a single gingival recession to be treated by a mucogingival surgery intervention
* to be in good systemic health
* to have a good oral hygiene

Exclusion Criteria:

* no systemic diseases; no coagulation disorders; no medications affecting periodontal status in the previous 6 months; no pregnancy or lactation;
* no smoking habits;
* no periodontal surgery on the experimental sites;
* no inadequate endodontic treatment
* no tooth mobility at the site of surgery
Prediction of Survival in Children With Cystic Fibrosis Using the Multiple-breath Washout

Retrospective cohort study using routinely collected annual data on lung clearance index (LCI) in combination with clinical data to predict survival in patients with Cystic Fibrosis. The primary study endpoint is the association of LCI with the compound outcome survival or lung transplantation in patients with CF.

Retrospective analysis of longitudinal data collected during clinically routine from approximately 200 patients with CF aged 3 years or more between 01.01.1980 and 31.12.2005. The overall aim of this project is to retrospectively assess whether LCI measured for clinical purposes during school age is predictive for survival or lung transplantation in adulthood. For this, the investigators will assess in a systematic way clinically measured LCI and relate them with the compound outcome survival or lung transplantation retrospectively.

Eligibility Criteria:
Inclusion Criteria:

* Patients treated at the Children's Hospital Bern
* Confirmed CF Diagnosis
* Age \>= 3 years

Exclusion Criteria:

* Uncertain diagnosis of CF according to current standards
* Existing written or otherwise documented refusal to participate in research
Aesthetic Analysis of Gluteal Deformity After Weight Loss and Assessment the Role of Autologous Tissue Augmentation for Gluteal Contouring

this study aim to evaluate the role of autologous augmentation for buttock contouring and analyze different aethetic gluteal deformity

The last decades showed an increasing demand for bariatric surgery and diet dependent massive weight loss , these successful strategies for weight loss result in significant deformities in general body contour , buttock normal appearance is very important for posterior trunk aesthetic image and its severely affected after massive weight loss .

Aesthetically attractive buttocks required special features include adequate volume, projection, and a defined infragluteal fold.. The gluteal region in patients with massive weight loss is characterized by excessive skin and exaggerated fat loss. Lower body lift procedures remove excess skin and lift sagging buttock tissue. unsatisfactory buttock shape especially V shaped buttock is considered as important indication for gluteal reshaping Mendieta and Cuenca-Guerra and Quezada have proposed novel methods of describing and analyzing gluteal aesthetics.

There are a multitude of options that can be used to improve the buttock includ-ing non-surgical injections, implants, fat, excisional, liposuction and various energy devices

Eligibility Criteria:
Inclusion Criteria:

* Female patients.
* patients who are seeking for gluteal contouring after massive weight loss
* age above 18 years and fixed weight for 6months.

Exclusion Criteria:

* Male patients
* Patients that will refuse the procedure,
* patients who thad a residual body mass index greater than 35
* patients have uncontrolled medical conditions.
Sustainable Habits for Encouraging Even Teen Sleep

This study will examine the feasibility, acceptability, and effectiveness of two digital sleep interventions in improving sleep regularity and psychiatric health during a critical period of adolescence.

This study will be testing two digital sleep health interventions for adolescents. Adolescents in both conditions will receive sleep education-related content. This project also uses an innovative digital platform and wearable sensors to deliver feedback.

The purpose of this research study is to evaluate a 6-week digital sleep intervention to promote healthy sleep patterns. The study will be broken up into two phases: Phase 1: Focus group participation. Participants and their guardian will be asked to participate in a focus group to get their thoughts/opinions on the intervention. Phase 2: Participants and their guardian will be asked to come to 4 different study visits: baseline, post-intervention, 3 month and 6 month follow up. Participants will be asked to complete questionnaires about demographics, psychiatric health, and sleep patterns. The participants will be asked to wear an ActiGraph watch for 24hrs/day for a week for 4 separate weeks, a Garmin for the duration of the 6-week intervention and keep a sleep diary through an online program.

Eligibility Criteria:
Inclusion Criteria:

* ages 12-14 years
* parent concern on the routines/consistency subscale of the Pediatric Sleep Practices Questionnaire, indicating poor sleep practices (score of 2) in at least one of the following: bedtime consistency, wake time consistency, and bedtime routines;
* ability to speak, read and write in English
* access to internet and smartphone device with capacity to download intervention App (iOS and Android)
* valid email address
* ability to follow written and verbal instructions
* ability and willingness to comply with study procedures.

Exclusion Criteria:

* diagnosed sleep disorder
* psychiatric disorder under treatment (medication and/or therapy) or intellectual disability
* chronic pain condition interfering with sleep
* substance use disorder
* use of medication for sleep (prescription or over-the-counter)
* has a sibling also enrolled/participating in the same study
Safety, Tolerability, and Immunogenicity of a Booster Dose of Zoster Vaccine, Live (V211-029)

This study was conducted to obtain safety and immunogenicity data after a booster dose of Zoster Vaccine, Live administered ≥10 years following an initial dose. This information was compared to similar information obtained after Zoster Vaccine, Live administration to age-matched and younger participants who received their first dose of Zoster Vaccine, Live. The study was designed to determine: 1) whether a booster dose of Zoster Vaccine, Live in participants ≥70 years of age induces an antibody response that is noninferior to that of a first dose of Zoster Vaccine, Live in participants matched for age; 2) whether a booster dose of Zoster Vaccine, Live induces an acceptable rise in the level of varicella-zoster virus (VZV) antibodies.

All participants were followed for one year after completion of the 42-day post-vaccination period while Groups 1 and 2 were followed for a total of three years.

Eligibility Criteria:
Inclusion Criteria:

* All Groups:

  * Must not have a fever of ≥100.4° F on the day of vaccination
  * Any underlying chronic illness must be in stable condition
  * History of varicella or residence in a VZV-endemic area for ≥30 years
* Group 1:

  * 70 years of age or older
  * Took part in the Shingles Prevention Study (SPS) (V211-004, NCT00007501) and received a single dose of Zoster Vaccine, Live ≥10 years prior to enrollment in this study
* Group 2:

  * 70 years of age or older
* Group 3:

  * 60 to 69 years of age
* Group 4:

  * 50 to 59 years of age

Exclusion Criteria:

* All Groups:

  * History of hypersensitivity reaction to any vaccine component or an anaphylactic/anaphylactoid reaction to neomycin
  * Prior history of herpes zoster
  * Pregnant or breast-feeding, or expecting to conceive within the duration of the study
  * Has been treated with immunoglobulin or any blood products, other than autologous (self-donated) blood transfusion, in the 5 months prior to vaccination
  * Received any other vaccine within 4 weeks prevaccination
  * On immunosuppressive therapy
  * Has known or suspected immune dysfunction
  * Is taking any non-topical antiviral therapy with activity against herpesviruses, including, but not limited to acyclovir, famciclovir, valacyclovir, and ganciclovir.
* Groups 2, 3, and 4:

  * Has previously received any varicella or zoster vaccine
Descriptive Study of Recombinant Human Insulin-Like Growth Factor for Osteoporosis in Werner's Syndrome

OBJECTIVES:

I. Assess the safety and efficacy of recombinant human insulin-like growth factor 1 in a patient with Werner's syndrome and osteoporosis.

PROTOCOL OUTLINE: The patient receives subcutaneous recombinant human insulin-like growth factor 1 daily for 7 months. The dose is adjusted according to the serum hormone level and biological markers of bone turnover.

Concurrent therapy includes a metabolic diet, calcium citrate, and estradiol.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Werner's syndrome with osteoporosis and low serum insulin-like growth factor 1 level Patient treated on protocol 04-9215300 "Metabolic and Skeletal Effects of Exogenous Recombinant Human Insulin-Like Growth Factor"
Adding MgSO4 to Epidural Levobupivacaine in CS for Patients With Preeclampsia

This study aims at evaluating the effect of adding magnesium sulphate epidurally as an adjunct to levobupivacaine on the quality of anesthesia and perioperative pain relief in patients with preeclampsia undergoing elective caesarian section (CS).

Pregnant women with preeclampsia undergoing elective CS in will be included in the study. All patients participating in the study will be randomly divided into two groups; magnesium sulphate group (study group) and placebo group (control group). Patients in the study group will receive epidural 20 ml levobupivacaine hydrochloride 0.5% plus 5 ml magnesium sulphate 10% (500 mg) while patients in the control group will received epidural 20 ml levobupivacaine hydrochloride 0.5% plus 5 ml saline 0.9%.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women with preeclampsia undergoing elective CS.

Exclusion Criteria:

* Age \< 20 or \> 35 years.
* Height \< 150 or \> 180 cm.
* Body mass index (BMI) \> 35 kg/m2.
* Active labor.
* Multifetal pregnancy.
* Fetal distress.
* Medical conditions complicating pregnancy.
* HELLP syndrome.
* Thrombocytopenia.
* Hepatic or renal impairment.
* Pulmonary edema or cyanosis.
* Placenta previa.
* Vaginal bleeding or placental abruption.
* Contraindication for central neuraxial block.
* History of adverse reaction to any study medication.
* History of analgesic use.
* Magnesium therapy.
* Chronic pain syndrome.
* Presence of communication difficulties preventing reliable assessment.
* Refusal to undergo regional anesthesia.
Electric Blower Based Ventilator Used During Procedural Sedation

Conduct human trials in the endoscopy suite of our continuous positive airway pressure (CPAP) ventilator approach using an FDA approved ventilator.

All study procedures will be performed in adult patients following informed consent at the endoscopy suite of the University of Utah Health Sciences Center in Salt Lake City, Utah. A ventilation mask will be placed on the patient's face and connected to the ventilator. Supplemental oxygen will be delivered by the ventilator through the mask; the concentration of oxygen delivered will be left to the clinician's discretion. A modified mask with multiple small leaks will be used with a standard elastomeric H-strap to secure it to the patient's face.

The endoscopy suite nurse and technicians will attach all clinically necessary standard sensors and connect them to the patient and monitoring system. Height, weight, and neck circumference will be measured and recorded digitally on an encrypted laptop. In addition to the standard of care monitors, the investigators will collect data from additional non-invasive modalities and save the data to a laptop using custom software for later analysis.

Pressure and flow sensors included in the ventilator will be used to monitor the patients' tidal volumes and respiratory rate during the procedure. The data that will be collected and recorded on the laptop will include: RIP data, mask pressure, flow, and breath rate. An additional flow sensor will be placed in line with the ventilator.

The objective of this study is threefold: Demonstrate in patients undergoing procedural sedation (e.g., for colonoscopy) that obstructive apnea can successfully be avoided by stenting the airway open using CPAP, demonstrate that we can successfully detect periods of zero ventilation, and demonstrate the functionality of the modified standard mask.

Eligibility Criteria:
Inclusion Criteria:

* \> 18 years of age
* undergoing a colonoscopy procedure
* receiving registered nurse-administered procedural sedation at the University of Utah Health Sciences Center
* agree to participate
* written informed consent

Exclusion Criteria:

* Inability/refusal of subject to provide informed consent.
* Standard colonoscopy exclusion criteria used at the GI lab at the University of Utah.
* Pregnant patients and patients with an ASA (American Society of Anesthesiology) physical status of IV or V.
* Patients with severe medical condition(s) that in the view of the acting physician prohibits participation in the study.
* Patients with a BMI \> 35 will not be included in the study
Effectiveness of Stress Free Now: an Internet-based Mindfulness Program for Stress Management

This research will examine whether an Internet-based mindfulness program for stress management produced positive outcomes for participants and is technologically feasible

Chronic, severe stress, a risk factor for premature aging and myocardial infarction, affects 35% of North Americans. Stress management programs, while effective, may be prohibitively resource intensive or difficult to access by broad populations.

This research is examining whether an online stress management program - Stress Free Now© (SFN) - can achieve meaningful improvements in measures of stress and wellbeing. We are also examining whether improvements in wellbeing and stress can be enhanced through an online, internet based support group which share experiences as they go through the Stress Free Now program. This program is modeled after an intensive group program, called Mindfulness Based Stress Reduction (MBSR), which has shown benefits across a broad array of medical issues in addition to more specific stress related problems.

This is a three arm randomized controlled trial which will last for 12 weeks. Participants will be randomized into one of the study arms: Non intervention Control, Stress Free Now and Stress Free Now + Message Board. We aim at enrolling 600 participants, with the expectation that 50% will complete the study (100 per group).

A series of questionnaires will be collected at baseline, at the end of the 8-week program and at follow up at week 12. Outcome measured are stress, mindfulness, vitality, physical, social and emotional health, transcendence and self-acceptance. We will also ask participants to complete a weekly log to measure program adherence and usage.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Sign-up for SFN (if in one of the intervention groups)
* Agree to participate in the research
* Have regular access to the internet
Optimization of Spontaneous Postoperative Trial of Void Among Women

Trial of void (TOV) is a diagnostic test performed on all women who undergo prolapse repair or incontinence surgery, due to the importance of diagnosing postoperative urinary retention (POUR). Incidence of POUR may be as high as 62% in some studies. Timely and accurate diagnosis is important to avoid complications such as urinary tract infection, bladder overdistension, and permanent bladder injury. Despite the frequent use of TOV, there is no gold standard for the test, and it likely has poor specificity, leading to discharge of more patients with catheter than required. This prospective cohort study will seek to establish evidence-based optimal parameters for spontaneous trial of void, a TOV modality that has merit for further evaluation given lower theoretical risk of urinary tract infection.

Patients will learn to perform self-catheterization ('clean intermittent catheterization', or CIC) preoperatively; after surgery, the investigators will collect a range of voiding parameters used during different TOV protocols (including minimum voided volume \[MVV\], post-void residual via bladder scanner \[PVR\], subjective force of urinary stream \[sFOS\]). Patients will discharge home to perform CIC until two sequential post-void residuals of less than half the volume voided have been achieved. The rate of voiding dysfunction and resulting PVRs will be used to compare the diagnostic accuracy of the perioperative voiding parameters to predict need to perform CIC and post-operative urinary retention.

Eligibility Criteria:
Inclusion Criteria:

* English-speaking women, age \>18yo
* Scheduled for urogynecology procedure which will need post-operative trial of void (including pelvic organ prolapse and/or stress urinary incontinence repair), with plan for same-day discharge.

Exclusion Criteria:

* Unable or unwilling to perform self-catheterizatoin either by patient or willing family member
* Pre-existing voiding dysfunction defined as documented PVR \> 200 mL
* Intraoperative urinary tract injury needing indwelling catheter on discharge
* Need for overnight admission