cyrilzakka/clinical-trials huggingface dataset:
Phase 3 Trial in Squamous Non Small Cell Lung Cancer Subjects Comparing Ipilimumab Versus Placebo in Addition to Paclitaxel and Carboplatin

The purpose of the study is to determine whether Ipilimumab plus Paclitaxel and Carboplatin will extend the lives of patients with squamous only non small cell lung cancer more than placebo plus Paclitaxel and Carboplatin.

The primary objective is to compare Overall Survival (OS) of participants with Stage IV/recurrent NSCLC of squamous histology who have been randomized to ipilimumab in addition to paclitaxel and carboplatin versus placebo in addition to paclitaxel and carboplatin, and have received at least one dose of blinded study therapy (ipilimumab or placebo).

Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

* Non small cell lung cancer (NSCLC) - squamous cell
* Stage IV or recurrent NSCLC
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria:

* Brain Metastases
* Autoimmune diseases
Non-Invasive Ventilation Via a Helmet Device for Patients Respiratory Failure

The objective of our study is to evaluate the efficacy of helmet ventilation as compared with Face mask in patients with respiratory failure.

Respiratory failure is often treated with endotracheal intubation and mechanical ventilation. Although, the institution of mechanical ventilation is considered life saving, the associated complications of tracheal stenosis, ventilator associated pneumonia, barotrauma , and neuromuscular weakness are not without considerable morbidity and mortality.

Non-invasive ventilation has demonstrated significant benefit in patients with hypercapnic respiratory failure from COPD, acute cardiogenic pulmonary edema, and hypoxemic respiratory failure in immunocompromised patients.

Despite the advantages of non-invasive ventilation via facemask, some patients fail because of mask intolerance and severity of disease. Further limitation to facemask non-invasive ventilation is that the seal integrity is lost when higher pressures are required. Unfortunately, certain types of respiratory failure such as that due to hypoxemia or shock may require such higher pressures.

In an attempt to improve patient tolerability and deliver higher pressures, a transparent helmet has been proposed as a novel interface for non-invasive ventilation. It encloses the entire head and neck of the patient. The design of the helmet confers some important advantages: 1) the transparency allows the patient to interact with the environment; 2) the lack of contact to the face lowers the risk of skin necrosis; 3) the helmet avoids problems of leaking with higher airway pressures that are seen with the face mask; 4) it can be applied to any patient regardless of facial contour.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged ≥18 years of age who require noninvasive ventilation via facemask for \>8hours
* Intact airway protective gag reflex
* Able to follow instructions

Exclusion Criteria:

* Cardiopulmonary arrest
* Glasgow coma scale \<8
* Absence of airway protective gag reflex
* Elevated intracranial pressure
* Tracheostomy
* Upper airway obstruction
* Pregnancy.
* Patients who refuse to undergo endotracheal intubation, whatever the initial therapeutic approach
Bilateral Priming for Upper Extremity Hemiparesis in Older Adults

This study will compare bilateral priming followed by task specific training to health care education followed by the same task specific training protocol. The intention is to understand the effects of priming on upper limb training post-stroke.

Techniques to enhance use dependent plasticity have been examined in stroke rehabilitation research. The purpose of these techniques is to prime the cortex prior to training. The priming techniques previously described in the literature include medication (i.e. amphetamines), transcranial electric or magnetic stimulation, and manipulation of somatosensory input. Here, the investigators examine a priming technique which is non-invasive and free of side effects. The technique described in this study uses bilateral, symmetrical, rhythmic movement "bilateral priming" and its purpose is to ready the motor cortex for functional limb training. A "rocker" is used so that the less affected limb can drive the affected one in symmetrical wrist flexion and extension. In this project, the investigators intend to compare bilateral upper limb priming with task specfiic training to a health care education website program followed by the same task specific training as the experimental group.This active comparator (health care education) will receive stroke related health education via a website from the American Heart Association. Transcranial Magnetic Stimulation willl include measurement of transcallosal inhibition persistence from the affected hemisphere to the less affected hemisphere and vice versa ( less affected to affected). The investigators expect the bilateral priming group to have greater changes in transcranial magnetic stimulation measures and greater improvements in behavioral measures at all time points.

Eligibility Criteria:
Inclusion Criteria:

* Must have survived a unilateral stroke at least six months prior to enrollment
* Fugl Meyer Upper Extremity Score between 22-38.

Exclusion Criteria:

* No individuals who have a pacemaker, metal implant in head or neck, history of seizures, recent concussion or history of headaches
Starting the Conversation

The purpose of the study is to evaluate the group-based intervention "Starting the Conversation" as a webinar in Germany. Feasibility and efficacy of the program will be tested in a pilot randomized-controlled trial (RCT).

Parents of children with mental illness often experience public and self-stigma, and keeping a child's mental illness secret is a common strategy to avoid stigma. Both secrecy and disclosure have pros and cons for parents and their children. Therefore, the decision whether, when, and to whom to disclose a child's mental illness is complex. Interventions can provide guidance for systematic consideration and a well informed decision.

The manualized peer-led group intervention "Honest, Open, Proud" (HOP) supports people with mental illness in their decision whether to disclose mental illness. Research showed positive effects of the intervention on stigma stress, disclosure-related distress and quality of life. Based on HOP, "Starting the Conversation" (STC) was developed to systematically guide parents through their decision whether and how to disclose a child's mental illness.

At the moment, there is no data regarding feasibility and efficacy of STC, but two pilot RCTs of STC are currently underway, one in Western Australia and one in Wisconsin, USA. The aim of the current study is to evaluate feasibility and efficacy of STC as a webinar in a pilot RCT in German.

Eligibility Criteria:
Inclusion Criteria:

* Parent with at least one child or adolescent that (i) is aged between 6 to 17 years (ii) has a current mental disorder according to ICD-10 diagnosed by a psychiatrist or psychologist
* Age ≥ 18 years
* Positive screening for disclosure distress (1 item: "In general, how distressed or worried are you in terms of secrecy or disclosure of the mental illness of your child?", self-report, persons with a score ≥ 4 on a scale from 1-7 were included)
* Online informed consent
* Sufficient German language skills

Exclusion Criteria:

* Intellectual disability of child (IQ\<70, self-report)
Intranasal Glucagon and Energy Balance

People who are overweight often find it difficult to lose weight through diet and medications because weight loss reduces the amount of energy spent by the body and increases appetite. Glucagon, when given as an injection, reduces appetite and increases the amount of energy spent by the body, even when resting. Based on studies in animals, it does so by working on the brain. However, when gives as an injection it raises blood sugar levels by acting on the liver and therefore it is not used as a weight loss drug. It has previously been shown that hormones such as glucagon, when given as a spray through the nose, can reach the brain with no major effect on the liver. Importantly it does not increase blood sugar. In this study the research team is investigating whether nasal glucagon reduces appetite and increases energy spent by the body compared to a placebo spray. If it does, it may be a potential treatment for losing weight.

Resting energy expenditure, appetite and food intake is being investigated in up to 20 individuals. Participants are their own control in a single-blind, placebo-controlled, crossover design. Participants are admitted after an overnight fast and allowed to rest for 1 hour before either intranasal glucagon (0.7mg) or intranasal placebo (sterile diluent) is administered. Study visits occur 1-3 weeks apart with intranasal glucagon or placebo applied in random order. Resting energy expenditure is measured via indirect calorimetry at baseline and over 90 minutes post-spray in 10-20 minute segments. Blood samples are taken at baseline and at regular intervals post-spray to measure glucagon, glucose and other hormones/metabolites. Appetite is assessed by visual analogue scale at 90 minutes post-spray followed by provision of a buffet-style meal for ad libitum food intake measurement.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index 25- 40 kg/m2
* Hemoglobin in the normal range
* Normal fasting glucose and HbA1C
* Women of reproductive age should be on contraception (oral contraceptive pill or intra-uterine device/coil) for at least 1 month prior to and after the study.

Exclusion Criteria:

* Any history of heart disease or clinically significant, active, cardiovascular history
* Study participant with active hepatic disease (except hepatic steatosis which is frequently seen in overweight/obese individuals)
* Any current or previous history of biliary disease (including gall stones, biliary atresia and cholecystitis) or pancreatitis.
* Any current or previous history of malignancy
* Any significant active (over the past 12 months) disease of the gastrointestinal, pulmonary, neurological, renal (Cr \> 1.5 mg/dL) genitourinary, hematological systems, or has severe uncontrolled treated or untreated hyper/ hypotension (sitting diastolic BP \> 100 or systolic \> 180 or systolic BP\<100).
* Allergy to any study medication
* Pregnancy or breastfeeding
Perioperative Copeptin: Predictive Value and Risk Stratification in Patients Undergoing Major Surgery

Observational cohort study examining the perioperative course of copeptin in patients undergoing elevated-risk surgery.


Eligibility Criteria:
Inclusion Criteria:

* Adults \>18 years
* Type of surgery for patients 1 to 30: abdominal aortic aneurysm repair, suprainguinal and infrainguinal vascular surgery, carotid surgery
* Type of surgery for patients 31 to 500: surgeries with elevated risks in general (as specified by 2014 ESC/ESA Guidelines on non-cardiac surgery:

cardiovascular assessment and management \[Kristensen\])

Exclusion Criteria:

* acute coronary Syndrome (ACS) at presentation (clinical assessment or documentation)
* Congestive heart failure at presentation (clinical assessment or documentation)
* Documented severe aortic stenosis (valve area \<1cm2)
* Kidney dysfunction (clearance \<50ml/min)
* Reduced left ventricular ejection fraction (LVEF) (\<40%); if no LVEF is available, it will be assumed to be \>40%
* Cancelled surgery
* Unwilling or unable to provide consent
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
The Effectiveness of Double-slot Brackets Versus Single-slot Brackets on the Rate of Canine Retraction

The aim of this Randomized clinical trial is to compare the efficacy of the double slot brackets compared to single slot-brackets in producing a controlled rate of upper canine retraction into premolar extraction space.

patients will be randomly divided into one of the two groups, CBCT (cone beam computed tomography) and dental models will be taken for each patient Pre-retraction and following the study completion.

The rate of retraction will be evaluated for both groups as well as Amount of canine root movement and molar anchorage loss will be also assessed.

Eligible patients will be examined for fulfilling the inclusion criteria. All the recruited patients need extraction of upper first premolars followed by canine retraction with maximum anchorage.

The patients will be randomly allocated to one of the two groups; either Double slot brackets or single slot-brackets group.

In Double slot bracket group, Canine retraction will be made on two 0.016'' StSt (stainless steel) round wires, each in one of the slots of the double slot brackets. while in single slot-bracket group, Retraction will be made on one 0.017''×0.025'' rectangular StSt arch wire .

The patients will be seen on a monthly basis for follow up visit for reactivation of retraction to maintain constant force during the study. An impression will be taken for the patients every visit, fabricated dental models will be digitally scanned. The scanned models will be used to monitor the rate of canine retraction.

Every patient will be asked to take a CBCT image of the upper arch pre Retraction and after the completion of study duration (3 months). After data collection, assessors will carry on the measurements blindly. Statistical analysis of the data will be done and the results will be compared to evaluate the effectiveness of both techniques for canine retraction.

Eligibility Criteria:
Inclusion Criteria:

* Good oral hygiene.
* Adult Male or Female patients with an age range of 16-26 years old.
* Full set of permanent dentition(excluding third molar).
* Any kind of malocclusion requiring first premolar extraction and canine retraction.
* Patients with type/pattern of crowding that allows leveling and alignment before premolar extraction

Exclusion Criteria:

* History of previous orthodontic treatment.
* Craniofacial deformity.
* Systematic disease or administrating drugs affecting tooth movement.
* Poor oral health.
Efficacy/Safety of Pseudoephedrine Plus Levocetirizine Versus Placebo in Patients With Vasomotor Rhinitis

The purpose of this study is to evaluate efficacy and safety of Cossac L tablet in the treatment of vasomotor rhinitis

randomized, double-blind, placebo-controlled, phase 3

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of vasomotor rhinitis

Exclusion Criteria:

* Significant concomitant medical condition
* Use corticosteroids or other allergy medications during the study
* Considered by investigator as not appropriate to participate in the clinical study with othe reason
Study of Phenotype and Genotype Correlations in Patients With Contiguous Gene Deletion Syndromes

OBJECTIVES: I. Investigate phenotype and genotype correlations in patients with Smith-Magenis syndrome (SMS) associated with del(17p11.2).

II. Clinically evaluate SMS patients with unusual deletions or duplication of proximal 17p.

III. Clinically evaluate patients with Williams syndrome with molecular characterization of 7q11.23.

IV. Perform clinical studies of Prader-Willi, Angelman, DiGeorge, and Shprintzen syndrome patients with unique molecular findings in 15q11q13 or 22q11.2.

V. Perform genotype and phenotype correlations in Prader-Willi patients, particularly those with loss of expression of only some of the imprinted transcripts in 15q11-q13.

VI. Evaluate putative Angelman syndrome patients who do not have classic large deletion, uniparental disomy, or imprinting mutations, and perform molecular studies of the Angelman gene, UBE3A, and identify mutations of this gene.

VII. Investigate phenotype and genotype correlations in patients with terminal deletions of chromosome 1p.

PROTOCOL OUTLINE: Patients undergo clinical, cytogenetic, and molecular studies. These include radiographic, neurologic, developmental, and 24 hour sleep studies, ophthalmologic, otolaryngologic, speech and language, and audiologic exams, echocardiogram, and renal ultrasound.

Smith-Magenis patients are also evaluated with the following: urine melatonin levels during day and night hours; anthropometrics; sleep and behavioral history; and renal, immunologic, and cholesterol studies. A clinical and phenotypic map is constructed.

When appropriate, parental chromosome analysis is performed.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Contiguous gene deletion syndrome, e.g.: Smith-Magenis syndrome Williams syndrome DiGeorge syndrome Shprintzen syndrome (velo-cardio-facial syndrome) Prader-Willi syndrome Angelman syndrome Deletion of chromosome 1p Patient age: Any age
Developing a Novel Therapy for Aversive Sensory Experiences in Autism

The goal of this study is to assess whether a new psychological treatment can lead to changes in sensory experiences in autistic young people. Participants will complete a group intervention designed to help manage sensory difficulties and associated anxiety. Participants will also complete tasks before and after the intervention to assess whether the treatment can lead to changes in brain and behavioural responses to sensory experiences.

The main questions the study aims to answer are:

1. Does the intervention improve sensory difficulties and associated anxiety in autistic young people?
2. Does the intervention change brain and biological responses to sensory experiences in autistic young people?

Researchers will also collect feedback from participants to help improve the design and delivery of the treatment in future studies.

The purpose of this study is to pilot a group-based cognitive behavioural therapy (CBT) intervention focused on managing sensory differences associated with autism. Another aim of this study is to test whether the intervention can modulate perceptual and neurophysiological markers (e.g. via electrocephalogram \[EEG\], heart rate and skin conductance) of sensory processing in autistic children and adolescents. A final aim will be to collect qualitative feedback from autistic young people with the aim of refining and improving the intervention for larger studies in the future.

The main aims of the study are:

1. To assess the feasibility of a novel CBT intervention for the management of sensory difficulties and associated anxiety in autistic youth.
2. To gather proof-of-concept data that the intervention can be used to modulate sensory neurophysiological and perceptual markers.
3. To gather qualitative feedback and PPIE to inform refinements on the design and delivery of the intervention for further studies.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed clinical diagnosis of autism
* Verbal/intellectual ability in average range
* Sufficient spoken English to be able to access the intervention
* Under the care of a local mental health service
* Not currently taking part in another psychological intervention

Exclusion Criteria:

* Verbal/intellectual ability below the average range
* Insufficient spoken English to be able to access the intervention
* Currently receiving a psychological intervention
* Individuals at high risk of harm to themselves or others
Screening & Health Education in Barbershop Centers for Hypertension

SALOON-HTN is a cross-sectional, descriptive, non-interventional, multicenter survey aiming to screen high blood pressure by measuring blood pressure in barbershops.

The survey is a screening project for hypertension, which will enroll subjects at the barbershops. The Metline Township (located at Bizerte Town, in the north of Tunisia) will be the geographical area of population enrollment. Barbershops hairdressers will be trained by a medical staff to measure the blood pressure by an ambulatory device.

All subjects willing to participate in the survey will be asked to measure their blood pressure by after at least 5 minutes rest. Three measures will be performed by the Hairdressers, with an interval of 3 minutes between each measure. The mean of the last two measures will be considered. If the mean blood pressure level exceeds 135/85 mmHg the subject will be sent to a physician of his choice.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years old
* Informed Consent to participate in the screening study

Exclusion Criteria:

* None
Sickle Cell Anemia in an Arab Bedouin Village in the Northern Israel

Sickle cell anemia and sickle cell thalassemia are frequent diseases among the israeli arab population. The purpose of this study is to assess the clinical characteristics of the patients in one arab village and the laboratory characteristics in the carriers of this gene based in the screening for pregnant women that is carried out in the population of northern Israel.

The results can be useful in order to institute universal screening for sickle cell anemia in northern Israel.


Eligibility Criteria:
Inclusion Criteria:

* All the patients that were diagnosed as having sickle cell disease in the specific village and all the population screened for hemoglobinopathies in the same location
Motivation for Exercise: a Mood-Based Focus

The goal of this study is to assess the effects of an exercise-related video on exercise motivation and adherence. Specifically, the researchers are studying whether an exercise-for-mood video increase levels of exercise motivation as compared to an exercise-for-fitness video.

This study is designed to evaluate two interventions for exercise motivation: an exercise-for-mood video and an exercise-for-fitness video. After screening to determine eligibility, participants will complete two virtual study appointments, scheduled 10-20 days apart. In Phase 1, participants will first consent to the study and complete the DASS-21, ASI-3, and EMI-2. Participants will then complete an interview-format 7-day Physical Activity Recall (7-day PAR) about their exercise over the past week. Participants are then randomized to either the Fitness or Mood video by the researcher and are assigned to watch the video while on the Zoom meeting, approximately 11 minutes long. After the video, participants complete two short questionnaires about the credibility and usefulness of the video they watched. Finally, participants are briefed on safe exercise habits and given a goal of moderate exercise 4 times per week.

In the Phase 2 appointment, participants complete the EMI-2 and the 7-day PAR about their exercise over the past week. Participants are then debriefed on the intent of the study.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Current PS101 student at Boston University
* A score of 14 or higher on the Perceived Stress Scale (PSS)
* Able to read English to provide informed consent
* Familiarity with a computer keyboard and mouse or a touch screen device
* Access to Zoom video conferencing software

Exclusion Criteria:

* Under age 18
* Known conditions prohibiting exercise adoption as identified by risk scores on the PAR-Q (a score of "yes" on one or more items)
* Presence of anorexia nervosa or atypical anorexia nervosa, or recent (6 month) suicidal ideation
* Score of 13 or lower on the Perceived Stress Scale (PSS)