cyrilzakka/clinical-trials huggingface dataset:
Effects of Different Myofascial Release Techniques on Iliotibial Band Tightness

The aim of the study is to investigate the effects of foam roller and instrument assisted soft tissue mobilization on pain, functionality and performance in athletes with iliotibial band tightness

Subject In this study, the effects of foam roller myofascial massage and instrument assisted soft tissue mobilization (IASTM) (massage performed by applying light pressure to the skin with a tool) on pain, functionality and performance will be investigated in athletes with iliotibial band tightness. There are studies on both IASTM and Foam Roller Massage in the literature and they are popular applications recently. However, within our knowledge, when we look at the Turkish and English literature, no study has been found that compares these two therapeutic massages in terms of pain, functionality and performance.

Purpose Poor posture, facial traumas and stiffness cause tension in the fascia of that region and result in pain. This disrupts the complementary mechanism of the fascia, causing the structures attached to the fascia to be out of the normal sequence. Facial problems have an important place in athletes. Facial problems cause pain in the athlete, reducing the athlete's sportive performance and negatively affecting their functionality. In order to prevent these limitations and accelerate the recovery, the rehabilitation process is started after the surgery. Various exercises and myofascial massages are routinely applied to problems seen in athletes. Myofascial massage techniques can be used in athletes' problems for many positive reasons such as effective in a short time, rapid results, high success rate, risk-free and painless if experts do. Thanks to the findings to be obtained from our study, it is aimed to contribute to the literature with objective, evidence-based results in this field.

Eligibility Criteria:
Inclusion Criteria:

* The leg inclinations of the athletes evaluated with the Ober test will be measured with an inclinometer and the athletes below 25 degrees will be included in the study.
* Age between 18 and 30 years
* Agree to participate in the study,

Exclusion Criteria:

• Not having surgery
Efficacy of a Standardized Centella Asiatica Extract in Patients With Temporomandibular Disorder

The goal of this clinical trial is to test analgesic effect of ECa 233 in subjects with TMD. The main questions it aims to answer are:

* Can ECa 233 reduce pain intensity score in subjects with acute TMD?
* Can ECa 233 increase jaw functional movements in subjects with acute TMD? Participants will be separated into four groups, including placebo, ibuprofen, low-dosed Eca and high-dosed Eca groups.

ECa 233 is a standardized extract of Centella asiatica with known anti-inflammatory properties and an acceptable safety profile. Hence, it would be relevant to evaluate the anti-inflammatory and pain reducing effects of ECa 233 on subjects with acute TMD, as well as jaw functional movements. A randomized, double-blind, placebo- and active-controlled clinical trial was performed on 18 to 50-year-old participants with acute TMD. These were randomly assigned to four treatment groups for 14 days: placebo, ibuprofen, ECa 233 250mg and 500 mg. At baseline, subjects reported 5 to 8 of pain intensity on a numerical rating scale (NRS). No medications were self-reported 24 h before and during the trial and no systemic conditions were diagnosed. Degenerative joint disease was screened before treatment. Pain intensity levels, mandibular range of motion including pain-free, unassisted and assisted mouth opening at baseline and days7 and 14 post-treatment. Masticatory muscle and jaw joint tenderness were evaluated upon palpation.

Eligibility Criteria:
Inclusion criteria

* Subjects reporting TMD pain lasting for 30 days or less (acute pain)
* Subjects with pain ratings between 5 and 8 on a 0-10 numerical rating scale

Exclusion criteria

* Subjects with any underlying chronic disease
* Subjects undergo any sort of treatment that may influence pain perception and/or inflammation, including as diabetes, psychological distress, systemic inflammatory disorders, oral appliances, and medications
Study to Assess the Safety and Bioeffect of REGN1033 (SAR391786)

This is a study to assess the safety and bioeffect of REGN1033 (SAR391786) in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

1. Males and postmenopausal females aged 60 years and older with no significant health issues or clinically significant abnormal laboratory values.
2. Low activity lifestyle
3. Diet and exercise adherence

Exclusion Criteria:

1. Significant concomitant illness such as, but not limited to cardiac, renal, rheumatologic, gastrointestinal, hematological, skeletal/muscular, neurologic, psychiatric, endocrine, metabolic or immunological disease.
2. Participation in any clinical trial within 6 months prior to screening.
3. Hospitalization, immobilization, or major surgical procedure requiring general anesthesia within 6 months prior to screening, or any planned surgical procedures during the study period.
4. Limb amputation (except for toes) and/or any fracture within 6 months.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial and not all inclusion/ exclusion criteria are listed.
TEAMS-BP (The Enhancement of Social Networks to Augment Management of Stroke-Blood Pressure)

This study aims to compare the efficacy of a social network intervention versus individual hypertension counseling to improve blood pressure control after stroke. The investigators hope to understand whether the involvement of family, friends and other members of individual's social network can help achieve better blood pressure after experiencing a stroke. Participants will be stratified to two groups according to network size (\<5 vs 5 or more) and randomized to receive individual hypertension counseling (control) or the social network intervention. The primary outcome of the study will be the absolute reduction in systolic blood pressure at 3 months follow-up. The secondary outcomes will be attainment of a post-stroke hypertension treatment goal and patient-reported physical function.


Eligibility Criteria:
Inclusion Criteria:

1. First acute ischemic stroke defined clinically with support from imaging if necessary
2. 21 years of age or older
3. Within 14 days after stroke
4. History of hypertension or has been newly prescribed blood pressure medications during index admission

Exclusion Criteria:

1. Prior ischemic or hemorrhagic stroke
2. NIHSS \> 21
3. Significant aphasia (Score\>1 on the language section of the NIHSS)
4. Medical conditions for which death is likely within 6 months
5. Does not have capacity to consent for the project or participate in survey interview
6. Diagnosis of dementia
7. Patient has no phone or incapable of using text messages
8. Patient has opted out of participating in research noted within MGB Epic EHR system
Fruit-based Chewing Gums for Improving Oral Health

This study aims to conduct a randomized cross-over study investigating the release of cranberry polyphenols from chewing gum formulated with polyphenol-lecithin precipitate (PLP). 10 participants will be on study for up to 2 weeks and will each complete 2-30 minute study intervention visits.

This study is intended to evaluate the bioavailability of a dietary supplement, cranberry PLP, compared to another dietary ingredient, cranberry extract. The intent of the evaluation is to provide preliminary data for future evaluation of cranberry PLP on the normal structure or function in humans, which includes the effect of cranberry PLP on oral health.

Participants will be asked to refrain from eating, drinking, or using tobacco products, and vigorous exercise for 1 hour before the intervention period. Participants will also be asked to avoid chewing gum 48 hours before the intervention. Water is acceptable up until 10 minutes before sample collection. Participants will be given these instructions during the informed consent process, and will be sent a reminder email about study protocols at least 72 hours in advance of the study visit. If their second visit is 48 hours after their first, the investigators will remind them of these restrictions at the end of their first visit.

On the day of each intervention and sampling period, participants will be asked to visit the Bolling Laboratory at the Department of Food Science adhering to the dietary guidance described above. Participants with appliances or dentures will be asked to remove them during sampling periods. Then, participants will chew the intervention or control gum for a total of 60 minutes while providing chewed gum and saliva samples at specified intervals throughout this time. Participants will come back to the Bolling Laboratory at a later time, a minimum of 48 hours after the last sampling period, to chew the other gum in the same manner as the first sampling period.

Eligibility Criteria:
Inclusion Criteria:

* healthy adults 18 years and older
* willing to avoid foods, beverages, tobacco products, and additional gum in the wash-in and wash-out periods
* willing to chew the intervention gum during the sampling periods
* willing to provide saliva and gum samples during the sampling periods
* willing to fill out post-visit surveys after their visits

Exclusion Criteria:

* Participants who do not consider themselves healthy
* have less than 20 natural teeth and 8 natural posterior teeth (excluding third molars)
* have a salivary rate ≥ 0.3 mL/min as determined from an unstimulated salivary flow trial
* taking medications that contraindicates grapefruit juice consumption
* allergic to any intervention foods or ingredients (e.g. sunflower, soy, food colorants, berry ingredients, or any other component of the study gum)
* diagnosed with phenylketonuria (PKU), gross untreated caries, advanced gingivitis and periodontitis, and temporomandibular joint disorder
* participants who are pregnant or lactating
Efficacy of Chlorexidine as Intracanal Medicament in Primary Teeth

The purpose of this study is to evaluate the action of the chlorexidine as intracanal medicament in the reduction of the levels of bacteria inside root canals of primary molar teeth with pulpal necrosis.


Eligibility Criteria:
Inclusion Criteria:

* Healthy children of both gender;
* Without history of reactions or alergical diseases;
* With situated age between 04 and 08 years of age
* With normal standard of growth and development
* Patients with necessity of radical endodontic treatment (pulpectomy) in, at least, two primary molar teeth in different hemi-arches.

Exclusion Criteria:

* Patients with history of alergical diseases
* Patients with allergy to any type of medicine and/or foods
* Patients with comprometimento of its general state of health
* Healthy patients with risk to develop bacterial endocardite or patients that their general state of health can be aggravated had the transitory bacteremies, as for example children with congenital cardiac illnesses
* Patients who are making use of sistemis antibiotics, or that they have made use of sistemic antibiotic in the period of 3 (three) months before the beginning of the endodontic treatment
* With periapical x-ray evidencing less than 2/3 of remaining root of the primary tooth to be treated
* Patients whose tooth with endodontic necessity to meet in advanced state of root pathological reabsortion
* Patients whose legal responsible or parents to refuse to sign the term of free and clarified assent
Effectiveness and Safety of 0.5% Moxifloxacin Hydrochloride Ophthalmic Solution in Perioperative Sterilization in Patients Undergoing Ophthalmic Surgery

This is a non-interventional, uncontrolled, prospective, multicenter, post marketing surveillance study.

The study treatment i.e., 0.5% Moxifloxacin hydrochloride ophthalmic solution will be prescribed as per approved label; the assignment of the patient to the therapy will be decided within the current practice and the medical indication and will clearly be separated from the decision to include the patient in the study.

The treatment period for each patient will be maximum 17 days from start of Moxifloxacin treatment. Study visit will be 1 day prior to surgery, day of surgery (Day 0) and 1 (day of surgery / post surgery), 7, and 14 days post-op (Note: Since its non-interventional study, the eligibility confirmation can be 1 or 2 days prior to the surgery depending on investigator's discretion).

After the patients sign the informed consent, the patients will be advised to start with Moxifloxacin ophthalmic solutions 2 days prior to the surgery and will be advised to administer it 5 times a day. On the Day 0, day of the surgery, the patient will be instilled 1 drop of Moxifloxacin in the eye which will be operated prior to surgery and 1 drop twice post surgery. From Day 1 post surgery, patient will have 1 drop of Moxifloxacin instilled three times a day up to Day 14 (14 days after surgery). If there are any signs and symptoms of endophthalmitis, then at the investigator's discretion, Gram Stain \& Culture assessment of aqueous \& vitreous fluid may be performed post surgery on Days 1, 7, and 14.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients \> 18 years of age, who have been prescribed 0.5% Moxifloxacin drops preoperatively and postoperatively for 2 weeks after ocular Surgery
* Patient or legally acceptable representative (LAR) willing to voluntarily provide signed informed consent for participation in the study

Exclusion Criteria:

* Patients with known history of hypersensitivity to fluoroquinolones
* Patients with history of serious underlying ocular or systemic disease or complication before surgery
* Patients diagnosed with an extraocular bacterial, viral, fungal infection prior to surgery
* Patients who have been administered other topical antibacterial agents within 24 hours of Moxifloxacin administration or systemic antibacterial agents within 72 hours of Moxifloxacin administration
* Patients who have planned to undergo cataract surgery in both eyes on same day
* Patients who have participated in another clinical study within 30 days prior to the start of this study
* Pregnant women/lactating mothers/ women suspected to be pregnant
A Phase 3 Study of KHK4827 in Patients With Systemic Sclerosis

To evaluate the efficacy and safety of KHK4827 in patients with systemic sclerosis who have moderate to severe skin thickening


Eligibility Criteria:
Inclusion Criteria:

* Subject meets the criteria for diagnosis of the Diagnostic Criteria, Severity Classification, and Clinical Practice Guidelines for Systemic Sclerosis （Japanese Dermatological Association 2016） at the pre-examination
* Subject presented the first symptoms of sclerosis other than Raynaud's phenomenon within 60 months before enrollment
* Subject who has systemic sclerosis accompanied by moderate to severe skin thickening with an mRSS of 10 to \<30 at the pre-examination and who has progressing skin thickening

Exclusion Criteria:

1. Any of the following significant concomitant diseases:

   * Type 1 diabetes
   * Poorly controlled type 2 diabetes (HbA1c \> 8.5%)
   * Congestive heart failure (Class II to IV of the New York Heart Association Functional Classification)
   * Myocartial infarction, unstable angina, or stroke occurring within 12 months before the first dose of investigational product
   * Poorly controlled hypertension (systolic pressure \> 150 mm Hg or diastolic pressure \> 90 mg Hg at screening)
   * Severe chronic lung disease (%FVC \< 60% and %DLco \< 40%, calculated according to the Reference Values for Spirometry, Including Viral Capacity, in Japanese Adults Calcluated with the LMS Method and Compared with Previous Values \[Japanese Respiratory Society\])
   * Major chronic inflammatory diseases or connective tissue diseases other than scleroderma
2. Patient has a history or evidence of a psychiatric disorder, alcohol and/or substance abuse, or any other mental health disorder that, in the opinion of the investigators, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion
3. Patient has a history or evidence of suicidal ideation (severity of 4 or 5) or any suicidal behavior based on an assessment with the Columbia-Suicide Severity Rating Scale (C-SSRS) at enrollment
4. Patient has severe depression based on a total score of ≥ 15 on the Patient Health Questionnaire-8 (PHQ-8) at enrollment
Factors Affecting Perioperative Outcomes

The specific aim of this study is to determine if pre-existing depression and anxiety affect perioperative outcomes measures patients undergoing surgery for pelvic organ prolapse.

* Hypothesis 1: Patients with depression will have increased analgesic use and longer hospital stays postoperatively
* Hypothesis 2: Patients with anxiety will have increased analgesic use and longer hospital stays postoperatively.

A secondary aim is to characterize the incidence and severity of depression and anxiety in patients scheduled to undergo surgery for pelvic organ prolapse.

Objectives: The purpose of this study is to assess preoperative depression and anxiety in patients scheduled to undergo surgery for pelvic organ prolapse and to determine if pre-existing depression and anxiety will affect perioperative outcomes in this patient population.

Methodology: Patients from the University of Oklahoma Urogynecology clinics who have been scheduled to undergo surgery for pelvic organ prolapse will be invited to participate in this study. Informed consent will be obtained prior to study enrollment. Data obtained from a preoperative visit with each participant will include demographic information, medical and surgical histories, and a complete physical examination. After enrollment into the study, each participant will be started on a standardized dose of analgesics. The visual analog scale will be used to assess the level of pain at the surgical site and pain medications will be adjusted as necessary. Information regarding their postoperative course will be tracked, including any complications, use of pain medications, and length of hospital stay.

Eligibility Criteria:
Inclusion Criteria:

* Age at least 21
* Scheduled to undergo surgery for the treatment of pelvic organ prolapse at the University of Oklahoma Health Sciences Center

Exclusion Criteria:

* Age \< 21
* Inability to complete the written questionnaires
* Undergoing concurrent procedures for condition other than pelvic organ prolapse
Cystic Fibrosis Foundation (CFF) Biomarkers of Exacerbation

Clinical and translational research in cystic fibrosis (CF) is hampered by a lack of biomarkers that can be used to identify promising new therapies. There is an urgent need for development and validation of biomarkers that more quickly predict the usefulness of potential drugs in CF and might prognosticate clinical course. In particular, combinations of protein biomarkers that can be obtained non-invasively offer great promise. The goal of this project is to determine whether protein biomarkers in blood can demonstrate a beneficial effect of treatment over two weeks. We intend to initially target an acute pulmonary exacerbation in CF because we know that subjects being treated with intravenous antibiotics and enhanced mucus clearance display clinical improvements within two weeks. We propose to prospectively collect blood samples from a large cohort of well-characterized CF persons serially during inpatient admissions for a pulmonary exacerbation and longitudinally during annual visits. Through this proposal, we hope to identify a CF lung injury biomarker panel that increases in the setting of an acute pulmonary exacerbation and improves rapidly following intravenous antibiotic therapy. Additionally, we will begin to explore whether this CF lung injury biomarker panel might also prognosticate clinical course including decline in pulmonary function. Finally, this study will serve as an important source of blood samples that will be banked for future biomarker and therapeutic studies designed to benefit the entire CF community.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of CF as evidenced by a sweat chloride test \>60mEq/L or by the presence of two known CF genetic mutations
* Male or female greater than or equal to 10 years of age
* Initiation of intravenous antibiotic therapy for a clinically diagnosed acute pulmonary exacerbation
* Ability to perform reproducible pulmonary function tests
* Willing to comply with the study procedures and willingness to provide written consent

Exclusion Criteria:

* Presence of a condition or abnormality that, in the opinion of the Principal Investigator (PI), would compromise the safety of the patient or quality of the data
Effectiveness of Relational Touch in Painful Elderly

The aim is to investigate the feasibility and efficacy of a relational touch / relational intervention on persistent pain in a long term geriatric hospital care ward population. The main issue is the pain reduction. The hypothesis is that this type of intervention is very useful on pain reduction in old people even with physical or mental disability.

The first 74 patients wanting to participate are randomly assigned to 2 groups: relational- touch or relational. Inclusion criteria are : patients with chronic pain; age \>65y and informed consent. Where patients had mental impairment the family's agreement is solicited. The regional Ethics Committee agreement was granted. The intervention consists of 6 Relational versus Relational- Touch sessions (twice a week) .Evaluation takes place after the second, 4th and 6th sessions and in the 4th week following the intervention. The main outcome is the pain reduction.

The primary outcome measure is the pain reduction according to the DOLOPLUS scale and the VRS; the secondary outcomes measures are : patient's participation rate; pain related symptoms variation; overall benefit.

Eligibility Criteria:
Inclusion Criteria:

* Age \>65 y
* Chronic pain \> 3 months
* Follow up 4 weeks
* Patient's speak french
* Patient's or representative's agreement to participate and to the informatics treatment of the data

Exclusion Criteria:

* acute pain
* unstable clinical status