cyrilzakka/clinical-trials huggingface dataset:
Effect of Hyaluronic Acid on Oral Mucosal Wound Healing - Focus on Pain and Re-epithelisation

Establishment of a sufficiently wide and thick keratinized gingival/mucosal tissue cuff around teeth/implants is considered of importance for long-term stability. This can more readily be achieved by means of autogenous soft tissue grafts harvested from the palate than with soft tissue substitutes. However, this often implies the creation of an open palatal wound involving secondary intention healing. The aim of this randomized controlled, split-mouth, clinical trial is to assess the effect of a hyaluronic acid containing commercial product on wound healing and patient morbidity after palatal soft tissue harvesting. Altogether, 20 volunteers will be recruited. An individualized splint containing 2 symmetrically located contralateral cylindrical openings will be used for standardized soft tissue harvesting (6 mm in Ø, 2 mm in depth). Soft tissue grafts will be harvested randomly from the right or left side and patients will be monitored for 3 weeks followed by a 1-month wash-out period prior to harvesting the second soft tissue graft from the other side. Participants will randomly start treating the palatal wound either with the test product (GUM Aftaclear Gel, Sunstar Suisse SA, Etoy, Switzerland; 0.3%) or saline solution for 7 days to promote the healing process, which will be reversed for the second round. Patient-related outcomes (morbidity, discomfort, taste alteration, pain killer consumption), frequency of bleeding events, defect closure (area, volume), and microbial colonisation will be recorded and analysed for any differences between the control and test product. Further, in 6 additional volunteers, biopsies of the healing wound are collected in a similar fashion as described above, but with the use of a larger stent in order to harvest also pristine surrounding tissues for histological analysis; biopsies are collected up to 14 days of healing.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-65 years,
* systemically healthy,
* healthy periodontal conditions at the experimental region or conditions not interfering with proper biopsy harvesting,
* no known sensitivity to HY,
* no uncontrolled diabetes mellitus,
* no radiotherapy or chemotherapy,
* no current pregnancy or breastfeeding,
* no hormonal diseases,
* no infectious diseases,
* no autoimmune diseases or under immunotherapy,
* no systemic bone disease,
* no wound healing disorders or acute inflammatory/infectious processes,
* no systemic diseases with implications on mucous membranes (e.g., Morbus Crohn),
* no increased risk of bleeding (i.e., patient with coagulation disorders or under anticoagulant therapy, and
* no heavy smokers (i.e., no regular tobacco consumption \> 10 cigarettes/day).

Exclusion Criteria:

* not meeting the inclusion criteria.
Effects of Diaphragm-releasing Techniques on the Lumbar Spine and Diaphragmatic Function in Healthy Women

The aim of this study was to evaluate the immediate effects of diaphragmatic release techniques on posterior chain flexibility and lumbar spine amplitude. Respiratory muscle strength and chest cavity mobility in healthy women.

The aim of this study was to evaluate the immediate effects of diaphragmatic release techniques on posterior chain flexibility and lumbar spine amplitude; Respiratory muscle strength and chest cavity mobility in healthy women. This is an intervention study with a randomized controlled trial design. The randomized study in two groups, the Intervention Group in which two diaphragmatic release techniques were performed and the Control Group where two placebo techniques were applied in 75 participants between 18 and 35 years of age. For intragroup analysis the paired Student t test was used, comparing the outcomes before and after the intervention and for intergroup analysis the independent Student t test.

Eligibility Criteria:
Inclusion Criteria:

* sedentary female participants
* aged between 18 and 35 years.

Exclusion Criteria:

* those with cardiovascular, respiratory obstructive or restrictive disease
* smokers and ex-smokers
* who were or were submitted to speech therapy less than a year ago
* those with postural deviation type scoliosis
The Causal Impact of Online Social Media on Physical Activity: A Randomized Controlled Trial

The overall objective of this research is to collect data for understanding whether messages in online environments impact fitness attitudes and behaviors. In particular, the study aims to experimentally examine what features of online social media - promotional messaging or peer networks - impact offline fitness measures (such fitness workshop enrollment and self-reported physical activity level). The study partners with an existing fitness program at a large northeastern university, which provides a 13-week fitness program for graduate and professional students at the university. The program begins with a university-run eligibility assessment of specific fitness measures for all participants, who win prizes for improvements in program participation and health behavior outcomes. The fitness program consists of semester-long series of workshops offered through the university's recreation department. The randomized trial constructs an online social media platform for the fitness program that provides a way to send either promotion health messages or messages about peer activities to the online community.

Sedentary lifestyle among university students and young adults has become a global epidemic. Widespread use of social media is both a contributing factor, and a potential solution; however the cost-effective use of social media to promote fitness on college campuses is poorly understood. This study aims to identify what features of social media - promotional messaging or peer networks - can increase physical activity levels.

In this randomized controlled trial, participants are randomized to three conditions: basic online program for enrolling in university-run weekly fitness workshops, media condition that supplements the basic program with promotional media messages, and a social condition that replaces the media content with a network of peers. Participants are limited to graduate and professional students at a large northeastern university.

Eligibility Criteria:
Inclusion Criteria:

* Graduate and professional students at a large northeastern university.
* Logging in to the study website at least once after online registration

Exclusion Criteria:

* Inability to perform physical activities (e.g., broken limbs), and underlying diseases that were likely to affect participant safety. Ineligibility is determined by the Department of Recreation and Health Services at the university.
Three Year Follow up of a Randomised Controlled Trial (RCT) of an Intervention for Tobacco Dependence Among Those With a Psychotic Illness

This is a three year follow up of a previous study where researchers at UNSW and UNewc asked smokers with serious mental health problems to participate in a 12-month study, to assess whether intervention could assist people experiencing mental illness reduce their tobacco smoking.

Between 2001 and 2003, the School of Public Health and Community Medicine at the University of New South Wales carried out a large study with the Centre for Mental Health Studies at the University of Newcastle. The project asked people with serious mental health problems, who also smoked cigarettes, to participate in a 12-month study, which involved completing several questionnaires/other assessments over that time with a member of the research team. Around half of the participants in this study also received treatment for their smoking from the research team. This treatment involved weekly therapy with one member of the research team, and covered the relationship between smoking and mental illness, teaching people to cope with desires to smoke, how to recognise and avoid high risk situations for smoking, and how to plan alternative ways of coping with those situations where smoking usually occurred. In addition, nicotine patches were also available to assist people who made the decision to reduce their smoking. This study hoped to learn whether this new treatment could assist people experiencing mental illness reduce their tobacco smoking.

After three years, previous participants were invited to participate in another follow-up assessment to check-in with their current situation, their mental health and levels of smoking.

Eligibility Criteria:
Inclusion Criteria:

* Previous participants from the original study
ECG Belt to Assess Electrical Synchronization

The objective of the study is to assess the utility of ECG Belt to understand the conduction and ECG characteristics of Left Bundle Branch Pacing (LBBAP) and His-Optimized Cardiac Resynchronization Therapy (HOT-CRT) and compare with preexisting data in traditional Cardiac Resynchronization Therapy (CRT) and Right Ventricular Pacing (RVP).

The objective of the study is to assess the utility of ECG Belt to understand the conduction and ECG characteristics of LBBP and HOT-CRT and compare with preexisting data in traditional CRT and RVP.

Specific Objective:

* To demonstrate and establish electrical resynchronization using ECG Belt Research System in Left Bundle Branch Pacing (LBBP) and HOT-CRT.
* To assess ECG Belt derived native conduction parameters and compare them to LBBP and HOT-CRT.
* To compare with historic ECG belt parameters obtained for right ventricular pacing/ Biventricular pacing in prior studies.

The ECG Belt study is a prospective, single-center, investigational, pre-market research study. The study team will identify all patients who satisfy the inclusion and exclusion criteria. The study team will evaluate the ECG Belt Research System to assess the electrical characteristics of conduction system pacing in patients with preexisting LBBP or HOT-CRT.

Eligible patients would have successfully undergone LBBP using Medtronic 3830 lead. LBBP will be confirmed at implant using left bundle potentials recorded from the lead, ECG morphology during unipolar and bipolar pacing, peak LV activation time and lead depth in the LV septum by contrast at implant and 2D echo post-implant.

ECG belt would be used to record ECG during baseline rhythm, LBBP in unipolar and bipolar configurations and / or during HOT-CRT using His-Bundle Pacing (HBP) or LBBP. These ECG belt characteristics would then be compared with baseline and existing data on Right Ventricular RV pacing and traditional Biventricular pacing.

Eligibility Criteria:
Inclusion Criteria:

1. Patients \> 18 years of age
2. Patient has a previously implanted LBBP lead for bradycardia indication or heart failure indication with one of the following at Geisinger within the last 5 years:

   * LBBP
   * LBBP+LV lead
   * HBP+LV
3. Patient is willing to comply with all study procedures and be available for the duration of the study.

Exclusion Criteria:

1. Inability to provide informed consent
2. Pregnant
3. Enrolled in a concurrent study that may confound the results of this study.
Comparing Effects of Conventional Neurorehabilitation with Exoskeleton with High-intensity Gait Training

The purpose of this research is to compare improvements between the rehab intervention with walking practice using the robotic exoskeleton versus walking practice that is vigorous enough to keep participants' heart rate over a certain target level during physical therapy sessions. Investigators want to compare improvements in your walking function and mental health that occur after 20 interventions. The study also aims to evaluate if participants' mental health, social support, and health literacy affect attendance at physical therapy sessions.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* English or Spanish-speaking
* A diagnosis of stroke (intracerebral hemorrhage or acute ischemic stroke)
* Referred to Good Shepherd Rehabilitation Outpatient Physical Therapy Clinic

Exclusion Criteria:

* Unable to follow 1-step commands
* \> 220 pounds (100 kg)
* Height \< 5'0" or \> 6'4"
* Unable to take a few steps with assistance
* A score of ≥ 50/56 on Berg Balance Scale (BBS)
* A score of ≥ 26/30 on Functional Gait Assessment (FGA)
* Resting blood pressure \>180/110 mmHg
* Resting heart rate \> 120 bpm
* Severe cardiac disease (New York Heart Association Classification IV)
* Severe spasticity (Modified Ashworth score \> 3)
* Unstable spine or unhealed pelvic/limb fractures
* Active heterotrophic ossification impacting lower extremity range of motion
* Significant lower or upper extremity contractures
* Inability to achieve neutral ankle dorsiflexion with 12° of knee flexion
* Pregnancy
* Colostomy
* Poor skin integrity in areas in contact with the EksoGTTM
* Unresolved deep vein thrombosis
* Lower limb prosthesis or amputation
* Leg length discrepancies \> 0.5 inches for upper legs, 0.75 inches for lower legs
* ROM restrictions preventing normal, reciprocal gait
* Inability to stand for \> 3 minutes due to pain or orthostatic hypotension
* Pusher syndrome
* Cortical blindness
MANUAL DIAPHRAGM RELEASE TECHNIQUE INCREASES TIDAL VOLUME IN ELDERLY

Question: Does manual diaphragm release change kinematics and respiratory function of elderly subjects? Design: Randomized controlled trial with concealed allocation and double-blinding.

Participants: 17 volunteers over 60 years old randomized into two groups: 09 in the Control Group (CG) and 08 in the Intervention Group (IG).

Intervention: The manual diaphragm release technique was used on the IG, in two sets of ten deep breaths, with a one minute interval between them. The CG underwent a sham protocol (light touch), with same sets and time of interval.

Outcome measures: The groups were evaluated using spirometry, manovacuometry and optoelectronic plethysmography (OEP), in that order, before and immediately after the intervention.


Eligibility Criteria:
Inclusion Criteria:

* over 60 years of age;
* a body mass index (BMI) below 30 kg/m2
* non-smokers, self-declared sedentary;
* presenting a forced expiratory volume in one second (FEV1) and forced vital capacity (FVC) greater than or equal to 80% of predicted;
* the ratio between these variables (FEV1/FVC) greater than 70% in spirometry

Exclusion Criteria:

* Showed the inability to understand verbal commands in the evaluation.
Safety and Efficacy of Early Administration of Dexamethasone in High-risk Sepsis

The purpose of this study is to investigate the safety and efficacy of early administration of two different doses of dexamethasone in high risk septic patients.

The septic adult patients of high risk would be enrolled in 2 emergency departments.

Sepsis would be defined by Sepsis-3 definition. High risk is defined as initial systolic blood pressure less than 90 mmHg or blood lactate level over 2 mmol/L.

The enrolled patients would be randomized to 3 groups: control, low dose dexamethasone (0.1 mg/kg iv), and high dose dexamethasone (0.2mg/kg iv).

The study drug is blinded and administered after enrollment for 2 days. Sample size would be 102, considering 10% of drop-out rate, allocating 30 patients to each groups.

Efficacy would be evaluated as follows; 28 day and 90 day mortality, time to septic shock, time to shock reversal, administration of steroid according to guideline, ventilator free days, Continuous renal replacement, Length of stay in ICU or hospital, delta SOFA score on day 3 and day 7,

Safety would be evaluated as follows; Superinfection Gastrointestinal bleeding, Hyperglycemia, Hypernatremia

Eligibility Criteria:
Inclusion Criteria:

* Sepsis defined by Sepsis-3 definition
* Initial systolic blood pressure \< 90mmHg or blood lactate level \>2mmol/L

Exclusion Criteria:

* advanced directive for "Do not resuscitation"
* recent systemic administration of glucocorticoid (4 weeks)
* recent systemic administration of chemotherapy (4 weeks)
* recent systemic administration of immunosuppressant (4 weeks)
* expected life less than 90 days
* Transferred from other hospital
* Sepsis diagnosed 24 hours after ED admission
* Use of etomidate in ED
* pregnant or on lactation
* no informed consent
A Study to Evaluate GBT021601-012 Single Dose and Multiple Dose in Participants With Sickle Cell Disease (SCD)

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK), and pharmacodynamics (i.e., how the body absorbs, distributes, breaks down, and excretes) of GBT021601, a hemoglobin S (HbS) polymerization inhibitor, in participants with SCD, following single and multiple ascending doses.

This is an open-label intrapatient single dose followed by a multiple dose escalation study in at least six (6) participants with SCD.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female with SCD
* Participants with SCD ages 18 to 60 years, inclusive.
* Participant has provided documented informed consent.
* Patients with stable and close to baseline hemoglobin value
* Patients on HU should be on stable dose for at least 90 days prior to signing ICF

Exclusion Criteria:

* Patients had more than 10 VOC within 12 months of screening
* Patients who are pregnant or nursing
* Patients who receive RBC transfusion therapy regularly or received an RBC transfusion for any reason within 60 days of signing the ICF
* Hospitalized for sickle cell crisis or other vaso-occlusive event within 14 days of signing the ICF or within 24 days prior to Day 1 treatment
To Vape or Not to Vape

The overall goal of this study is to increase knowledge of vaping and its associated risks. This study will find the patterns of vaping, and how it all started among adolescents. Investigators want to know if students are aware of the serious and long term effects of vaping. This program titled, "To Vape or Not to Vape", will provide education to adolescents and young adults about the potential risk of vaping in an effort to assist with lowering the usage rates within the population. Content will include information about current statistics, potential short-term and long-term side-effects, and healthy alternatives for dealing with stress and peer-pressure. Investigators anticipate that this program will increase this population's knowledge about the risks of vaping products, and deter them from future use of the products. Effectiveness of this program will be measured by pre and post-tests. Investigators believe this program will make at least 50 percent of the participants more aware of the dangers and consequences of vaping, potentially lowering the rates of those participating in this habit while also preventing others from starting.

The overall goal of this study is to increase knowledge of vaping and its associated risks. This study will find the patterns of vaping, and how it all started among adolescents. Investigators want to know if students are aware of the serious and long term effects of vaping. This program titled, "To Vape or Not to Vape", will provide education to adolescents and young adults about the potential risk of vaping in an effort to assist with lowering the usage rates within the population. Content will include information about current statistics, potential short-term and long-term side-effects, and healthy alternatives for dealing with stress and peer-pressure. Investigators anticipate that this program will increase this population's knowledge about the risks of vaping products, and deter them from future use of the products. Effectiveness of this program will be measured by pre and post-tests.

Eligibility Criteria:
Inclusion Criteria:

* The program's targeted population is starting at the middle school grade levels, up to college.
* Live in the DFW metroplex
* Willing to participate throughout the presentation

Exclusion Criteria:

* Less than 12 years old
* Students that are not in the DFW metroplex
Intraabdominal Hypertension and Occurrence of Microaspiration in Cirrhotics Under Mechanical Ventilation

The study aims to demonstrate the relationship between intra-abdominal hypertension (IAH) and abundant microaspirations in mechanically ventilated cirrhotic.

Intra-abdominal pressure monitoring will be performed using intra-vesical pressure every 8 hour in the first 2 days of mechanical ventilation.

Micro aspiration is defined by pepsin or amylase positivity in trachea suction. Two groups will be compared : one with IAH , one without IAH.

Eligibility Criteria:
Inclusion Criteria:

* adult patients
* Cirrhosis
* intubation and mechanical ventilation

Exclusion Criteria:

* pregnancy
* oliguric patients
* impossibility to measure intravesical pressure
A Study of EUR-1066 in Subjects With Chronic Pancreatitis, Exocrine Pancreatic Insufficiency and Chronic Abdominal Pain

The purpose of this study is to evaluate two different treatments in subjects with chronic pancreatitis, exocrine pancreatic insufficiency and chronic abdominal pain.

To evaluate two different preparations of a pancreatic enzyme in subjects with chronic pancreatitis, exocrine pancreatic insufficiency, and chronic abdominal pain.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Chronic Pancreatitis
* Exocrine Pancreatic Insufficiency
* Chronic abdominal pain

Exclusion Criteria:

* Acute pancreatitis
* Active alcohol consumption
* Uncontrolled diabetes
Preoperative Stereotactic Radiosurgery for Brain Metastases

STEP is a French multicentre, prospective, non-randomized, phase II study designed to assess 6-months local control after pre-operative stereotactic radiosurgery (SRS) for patients with brain metastases


Eligibility Criteria:
Inclusion Criteria:

* ≤ 4 distinct brain metastases, one with surgical indication
* Diagnosis of primary histologically proven breast, digestive or non-small cells lung cancer
* ≤ 5 cm larger diameter
* Karnofsky performance status ≥ 70
* No contraindication for MRI
* Possibility for the patient to be treat with both surgery and stereotactic radiotherapy
* ≥ 18 years old
* Estimated overall survival ≥ 6 months according to diagnosis specific - graded prognostic assessment (DS GPA)
* Written inform consent signed
* Affiliation to the French social security system
* For women of childbearing age including those on luteinizing hormone-releasing hormone (LH-RH) agonists for ovarian suppression: inclusion negative serum pregnancy test (≤ 7 days prior to the start of preoperative stereotactic radiosurgery (SRS).

Exclusion Criteria:

* Lymphoma, leukaemia, multiple myeloma, germinal tumours or cerebral primary cancer
* Metastases from small-cells lung cancer, kidney cancer, melanoma or sarcoma
* Mass effect with deflection ≥ 5 mm from median line or hydrocephaly or compression 4th ventricle, patient neurologically unstable, need for emergency decompressive surgery
* \> 4 brain metastases
* Contraindication to anaesthesia, MRI or gadolinium injection
* Proximity of the tumour with organs at risk which do not allow the prescribed dose to be reached in the envelope
* Pregnant or breastfeeding woman
* Anti vascular endothelial growth factor (VEGF) within 6 weeks before treatment
* Documented leptomeningeal injury
* History of irradiation of the encephalon in toto
* History of stereotactic radiotherapy on metastasis to be operated on
* Non-candidate patient for surgery
* Surgical delay \> 3 days compared to stereotactic radiotherapy
* Estimated survival \< 6 months by DS GPA
* Patient under guardianship or curators
* Psychological disorder (cognitive disorders, mental alertness, etc.) or social (deprivation of liberty by judicial or administrative decision) or geographical reasons that may compromise medical monitoring of the trial or compliance with treatment
* Woman of childbearing age without effective contraception
* Patient participating in another intervention study within 4 weeks prior to inclusion