cyrilzakka/clinical-trials huggingface dataset:
Ultrasound Guided Rhomboid Intercostal Block for Myofascial Pain Syndrome

Rhomboid intercostal block (RIB) is an interfacial plane block described in 2016. It creates analgesia at T2-T9 levels in the hemithorax by applying local anesthetic to the fascia between the rhomboid muscle and the intercostal muscle. It has been used effectively in patients with chronic pain. Recently published report has shown that rhomboid intercostal block (RIB) may provide effective pain control for myofascial pain syndrome (MPS), too. MPS is a regional pain syndrome characterized by trigger points detected in one or more regional muscle groups. The investigators planned a prospective observational study, a total of 30 patients who will apply to our clinic with MPS, will register in research. The investigators will perform ultrasound-guided RIB, and evaluate the clinical outcomes.

Myofascial pain syndrome (MPS) is the most common cause of musculoskeletal pain and its prevalence in the population is reported to be 21-30%. Rhomboid intercostal block (RIB) is an interfacial plane block described in 2016. It creates analgesia at T2-T9 levels in the hemithorax by applying local anesthetic to the fascia between the rhomboid muscle and the intercostal muscle. It has been used effectively in patients with chronic pain. The investigators planned a prospective observational study.From february to march 10 2021, a total of 30 patients who will apply to our clinic with MPS, will register in research. The investigators will perform ultrasound-guided RIB, and evaluate the clinical outcome Ultrasound guided RIB will applied with linear probe, in plane technique. Block needle was inserted to plane between the rhomboid muscle and intercostal muscles over the T5-6 ribs 2 cm to 3 cm medially from the medial border of the scapula. 13ml of bupivacaine 0.25% and 8mg dexamethasone mixture will inject into the fascial plane. Numerical Rating Scale (NRS) will recorded before and after the block at 30 minutes, day 1, 1-2-4-6 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Complaint of myofascial pain
* Pain that is rated at least 3 on a numerical rating scale (NRS, 0 = no pain, 10 = the worst pain)

Exclusion Criteria:

* pregnancy
* the presence of coagulopathy, or the use of anticoagulants
* a history of surgery on the block area
* allergic to bupivacaine
* decline to participate
Six Months Evaluation of Next Science Acne Creams on Facial Acne in Adult Females.

To assess facial acne vulgaris clinical and psychological outcomes by measuring differences in lesions counts, investigator global assessment, and subjects quality of life scores over 6 months in adult females treated with Next Science™ acne cream 2x or Next Science™ acne cream 1x in a double blind manner.

This is a 6-month, single-site, double-blind, controlled study in 20 female subjects with mild to moderate facial acne. Subjects will be randomized 1:1 to apply either topical Next Science™ acne cream 2x or Next Science™ acne cream 1x daily. Subjects will be evaluated for clinical acne and quality of life outcomes at baseline, 6, 12, 18 and 24 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Female ages 18 and above
2. Has 20 or more inflammatory lesions on the face (papules and pustules) as determined by qualified examiner at Start of Treatment.
3. In the area to be treated, has no significant facial dermatological conditions other than acne (as determined by the investigator) that would interfere with any study treatment or procedure
4. Is willing and able to discontinue use of all baseline acne treatments for the duration of their trial participation
5. Agrees to refrain from professional facial treatments during their trial participation.
6. Agrees to avoid tanning booth use and minimize sun exposure during their trial participation.
7. Is willing and able to follow instructions and procedures including attending scheduled study visits, which will require adequate transportation to the study site
8. Is able to read, understand and sign the informed consent document and communicate with study staff and investigator.

Exclusion Criteria:

1. Has more than 2 nodules/cystic acne lesions on the face
2. Has a history of significant reactions to topical acne treatments, or a known allergy or hypersensitivity to any listed ingredients
3. Has any history of skin malignancy
4. Has used any systemic medications (including antibiotics, estrogens, retinoids) primarily for treatment of acne in the 21 days prior to randomization.
5. Has used estrogens primarily as treatment for acne in the 21 days prior to randomization (estrogens prescribed for other reasons will be allowed if stable for at least 30 days prior to randomization).
6. Has had any professional facial treatments in the 14 days prior to randomization.
7. Has received any investigational treatment in the 30 days prior to randomization.
8. Have any significant medical problems or other issues that would, in the investigator's judgment, affect their suitability for participation in this trial.
Comparison of the Relative Oral Bioavailability of GKT137831 Formulated in Capsules or in Tablets

The study will be a comparative oral bioavailability study between GKT137831 capsules and tablets, together with an assessment of the impact of concomitant food intake on the relative bioavailability of GKT137831 tablets.

This will be a randomized three-way open cross-over study.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy male subject, aged 18 to 60 years inclusive;
2. Non-smoker subject or smoker of not more than 5 cigarettes a day ;
3. No history of alcohol or drug abuse
4. Body Mass Index (BMI) between 18 and 27 5 kg/m2 inclusive;
5. Considered as healthy after a comprehensive clinical assessment (detailed medical history and complete physical examination);
6. Signing a written informed consent prior to selection;

Exclusion Criteria:

1. Blood donation (including in the frame of a clinical study) within 2 months before administration;
2. General anaesthesia within 3 months before administration;
3. Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician;
4. Inability to abstain from intensive muscular effort;
5. No possibility of contact in case of emergency;
6. Any drug intake (except paracetamol) during the last month prior to the first administration;
7. History or presence of drug or alcohol abuse (alcohol consumption \> 40 grams / day);
8. Excessive consumption of beverages with xanthine bases (\> 4 cups or glasses / day);
9. Positive Hepatitis B surface (HBs) antigen or anti Hepatitis C Virus (HCV) antibody, or positive results for Human Immunodeficiency Virus (HIV) 1 or 2 tests;
10. Positive results of screening for drugs of abuse;
11. Subject who, in the judgment of the Investigator, is likely to be non-compliant or uncooperative during the study, or unable to cooperate because of a language problem, poor mental development;
12. Exclusion period of a previous study;
13. Administrative or legal supervision;
Effect of Local Infiltration Anesthesia in a Hip Arthroplasty Fast Track Program.

Fast-track programs in Orthopaedic Surgery require early motion that can only be achieved by optimal pain management protocols. Multimodal analgesia protocols including local infiltration anesthesia (LIA) have obtained excellent results in fast-track programs involving Total Knee Arthroplasty but further research and data is needed in Total Hip Arthoplasty programs.


Eligibility Criteria:
Inclusion Criteria:

* Hip osteoarthritis requiring Total Hip Replacement

Exclusion Criteria:

* Mental Disorders
* contraindications for epidural anesthesia
* Neurologic disorders that could interfere with pain evaluation
* allergy to drugs in multimodal analgesic protocol
Obalon in Children With Severe Obesity

The ongoing global rise in the prevalence of overweight and obesity among all ages and among all ethnic groups, figures into a real epidemic phenomenon. This is accompanied by a higher incidence in serious health risks, already present at an early age, "switching-on" the engine towards obesity-related co-morbid diseases and morbid obesity. Weight loss is the only way to avoid systemic and cardiovascular complications of obesity.

Weight loss devices have been recently introduced in bariatric surgery, also in children. They mostly require invasive procedures to be applied. Mini-invasive devices would be needed to obtain weight loss in the pediatric population, since the early age of involved patients.

Obalon intragastric balloons, are swallowable devices. They are filled with liquid or air, and have been used to induce weight loss in obese adults. The investigators aimed to perform a pilot study in pediatrics, and monitor weight loss, metabolic and cardiovascular parameters modifications, after up-to-3 Obalon® Gastric Balloons placement.


Eligibility Criteria:
Inclusion Criteria:

* Weight \> 97° pc -CDC BMI charts-

Exclusion Criteria:

* Prevous abdominal surgery
* Functional gastrointestinal motility disorders
Effect of Different Centrifuge Values on Saliva High Sensitive C-Reactive Protein (Hs-CRP) Levels in Individuals With Different Smoking Amounts

The purpose of this study; In periodontally healthy individuals, high sensitive c-reactive protein (hs-CRP) levels of non-smokers, smokers of less than 10 cigarettes per day and smokers of more than 10 cigarettes per day were measured at 15 rpm-10 min, 10 centrifuge values, which are frequently used in saliva studies. To determine the levels in saliva samples as a result of rpm-10 min and 10 rpm 6 min centrifugations and to determine the values at which a cytokine of this molecular weight should be centrifuged and to examine the possible correlation between these values and the clinical parameters of the amount of smoking. Materials and Methods: saliva samples were collected from 90 systemically healthy individuals who were non-smokers (N, n=30), light smokers \<10 cigarettes per day (L, n=30) and heavy smokers \>10 cigarettes per day (H, n=20). samples were taken. Full-mouth clinical periodontal measurements, including probing depth (PD), clinical attachment level (CAL), bleeding on probing (BOP), gingival index (GI), and plaque index (PI), were also recorded. Enzyme-linked immunosorbent assay (ELISA) was used to determine hs-CRP levels in biological samples.


Eligibility Criteria:
Inclusion Criteria:

* Systemically healthy
* Periodontally clinical healthy
* At least 20 permanent teeth in the mouth
* No medication for continuous use
* Those who have not used antibiotics, anti-inflammatory and systemic corticosteroid drugs in the last 6 months.
* Not in pregnancy or lactation period.
* Not received periodontal treatment in the last 6 months

  * For the non-smoker group; person who does not smoke tobacco
  * For the light-smoker group; person who smokes less than 10 cigarettes a day
  * For heavy-smoker group; person who smokes more than 10 cigarettes a day

Exclusion Criteria:

* Any oral or systemic disease
* Regularly using a systemic medication
* During pregnancy or lactation
* Received periodontal treatment within the last 6 months.
* Those who received antibiotic, anti-inflammatory or systemic corticosteroid medication in the last 6 months
* Individual with periodontal disease
Assessment of Third Trimester Post-void Residual and Validation of Bladder Scanner in Pregnancy and Post-partum

This will be a descriptive study measuring the post-void residual of patients in the third trimester and postpartum. Also, bladder scan values will be compared to the amount of urine obtained from a Foley catheter to determine the accuracy of the bladder scanner in the third trimester and postpartum.


Eligibility Criteria:
Inclusion Criteria:

* Age greater than 18 years.
* Having a non-emergent Cesarean Delivery or labor epidural placed.

Exclusion Criteria:

* Age less than 18 years.
* Emergent Cesarean delivery.
* No epidural labor analgesia.
Pharmacodynamics, Preliminary Pharmacokinetics and Tolerability of BIBB 1464 (Tablet) in Hyperlipemic Healthy Male Subjects

Lipid lowering effect, investigation of pharmacodynamics (inhibition of oxidosqualene cyclase, monoepoxysqualene (MES) as marker), safety / tolerability and preliminary pharmacokinetics


Eligibility Criteria:
Inclusion Criteria:

* Healthy male Caucasian subjects as determined by results of screening
* Written informed consent in accordance with GCP and local legislation given
* Age \>= 18 and \<= 65 years
* Broca \>= - 20% and \<= + 30%
* LDL-cholesterol level \>= 3.3 mmol/L at pre-screening and at the two screening visits

Exclusion Criteria:

* Any finding of the medical examination. (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal (including thyroid) disorder
* Surgery of the gastro-intestinal tract (except appendectomy)
* Disease of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
* History or orthostatic hypotension, fainting spells or blackouts
* Chronic or relevant acute infections
* History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged the investigator
* Intake of drugs with a long half-life (\> 24 hours) (\<= 1 month prior to administration or during the trial)
* Use of any drugs which might influence the result of the trial (\<= 10 days prior to administration or during the trial)
* Participation in another trial with an investigational drug (\<= 2 month prior to administration or during the trial)
* Smoker (\> 10 cigarettes or \> 3 cigars or \>3 pipes/day)
* Inability to refrain from smoking during the period of the study
* Alcohol abuse (\>60/g/day)
* Drug abuse
* Blood donation (\>400ml \<=1 month prior to administration)
* Excessive physical activities (\<=5 days prior to administration)
* Any laboratory value outside the normal range of clinical relevance
* LDL - cholesterol screening measurements day -1 and day -7 the different between these two values exceed 12% of the higher dose
* subjects who are vegetarian

Eye-lens

* Cataract extraction in one or both eyes deemed likely within 2 years ("senile", non-idiopathic will not automatically exclude patients from participation)
* Lens Opacities Classification System (LOCS) III grade \>3.0 (for nuclear opalescence or cortical grad) \>0.5 (for posterior sub capsular grad)
* Log MAR Bailey-Lovie visual acuity \>0.5
* Corneal or conjunctival problems which would preclude lens photography
* Shallow anterior chamber with risk of angle-closure glaucoma
* Pupil will not dilate to at least 6 mm
* Visually significant fundus pathology in clinician's judgment
* Amblyopia, optic nerve disease, iritis, history of eye surgery, argon or YAG laser, major eye trauma, extended use (daily for \>3 month) of ocular or systemic corticosteroid treatment , use of anticoagulants, or glaucoma therapy, or participation in another clinical trial investigation an anti-cataract or cataractogenic formulation within the last year
A Study to Compare the Pharmacokinetics and the Safety Between a Fixed-dose Combination Administration of "BR3005" and Co-administration of "BR3005-1" and "BR3005-2" Under Fasting Conditions in Healthy Adult Volunteers

The objective of this clinical study is to compare the pharmacokinetics and the safety between a fixed-dose combination administration of "BR3005" and co-administration of "BR3005-1" and "BR3005-2" under fasting conditions in healthy adult volunteers


Eligibility Criteria:
Inclusion Criteria:

* Those who have body mass index (BMI) within the range of 18.0 to 30.0kg/m² at screening visit

  * In case of a male subject, Those who weigh 50 kg or more
  * In case of a female subject, Those who weigh 45 kg or more
* Those who sign written consent spontaneously after listening to and understanding sufficient explanation of the purpose and contents of this clinical trial, characteristics of the Investigational products, expected adverse events, etc.

Exclusion Criteria:

* Those who have taken drugs that induce and inhibit metabolizing enzymes such as barbiturate within 30 days prior to the first day of administration or have taken drugs concerned about affecting this clinical trial within 10 days prior to the first day of administration. (however, participation is possible considering pharmacokinetics and pharmacodynamics such as Interaction of investigational products, half-life of concomitant drugs, etc.)
* Those who have participated in other clinical trials(including bioequivalence tests) and administered their investigational products within 6 months prior to the first administration date.(However, the termination for participation in other clinical trials are based on the last administration date of their investigational products)
* Those who have a medical history of gastrointestinal surgery or gastrointestinal diseases that may affect the absorption of drugs. (Except for simple appendectomy, hernia surgery)
* In the case of a female subject, those suspected pregnancy, pregnant woman, lactating woman.
Radiant Warmer Trial

The purpose of this study is to compare three radiant warmer beds that contain different computer heating software and different bed styles. Radiant warmers are used in many neonatal intensive care units (NICU) to provide heat to infants to help regulate an infant's temperature. It is common for babies to require care on an open bed that provides heat to the baby according to the baby's needs and at the same time allows easy access to the baby for care and necessary procedures. There are different styles of beds, each with unique computer software that can guide how a bed's heater output is automatically adjusted according to a baby's temperature needs. It is unknown which style of bed or method of heating might be best. This study seeks to evaluate infant responses to three different types of radiant warmer beds.

Study was withdrawn

Eligibility Criteria:
Inclusion Criteria:

* Any baby \> 32 weeks gestation and \> 1500 grams that requires initial care on a radiant warmer during confinement in the neonatal intensive care unit.

Exclusion Criteria:

* Any baby who has a skin condition that may prevent or compromise thermistor placement and interfere with accurate temperature readings from thermistors or IR camera.
* Any baby who is deemed too sick to tolerate movement from one radiant warmer to another by the attending physician.
* Any baby who has a medical condition or anomaly that contraindicates axillary or abdominal temperature measurements
Epidemiology, Identification Rate and Treatment Penetration of Osteoporotic Vertebral Fractures in Switzerland

In Switzerland, the prevalence of vertebral fractures in community- dwelling women is unknown and the published data from the Swiss hospitals statistics represent only the tip of the iceberg. In addition, the percentages of women correctly identified with vertebral fractures due to osteoporosis and the treatment rate of these women with a drug proven to reduce the risk of further fractures are unknown. Furthermore, it is not known whether the prevalence of vertebral fractures differs between urban and rural areas or between mountain areas and plain country, e.g. due to possible differences in sun exposure (vitamin D production) and/ or in physical activity and/ or dietary habits.

Clinical signs and symptoms leading to the suspicion of vertebral fracture(s) lack either sensitivity (wall-occiput distance) or specificity (rib-pelvis distance). Whether a combination of both would improve sensitivity and specificity is unknown.

The gold standard for the diagnosis of vertebral fracture relies on antero-posterior and lateral X-Rays of the thoracic and lumbar spine. Despite standardization of X-Ray readings, a retrospective study of hospitalized elderly patients has shown that as many as 50% of the radiographic reports failed to note the presence of moderate to severe vertebral fractures. In a primary care setting, fewer than 2% of the women received diagnoses of osteoporosis or vertebral fracture, although expected prevalence is 20% to 30% and appropriate drug treatment was offered to only 36% of the diagnosed patients.

The recent availability of software for vertebral fracture assessment (VFA) coupled to DXA measurements allows for the detection of vertebral deformities, which is critical for management of osteoporosis, as the existence of such deformities substantially increases the risk of subsequent fracture. Recently published results show that VFA allows the diagnosis of a vertebral fracture. The sensitivity of VFA for detection of vertebral fractures compared to expert radiologist reading of X-ray is excellent for grade 2 and 3 fractures, ranging between 90-94%.

Examinations

* Community-dwelling women from a random sample (address lists may be chosen from public and/ or private providers)
* Aged 65-79 yrs
* Written informed consent

Eligibility Criteria:
Inclusion Criteria:

* Community-dwelling women from a random sample (address lists may be chosen from public and/ or private providers)
* Aged 65-79 yrs
* Written informed consent

Exclusion Criteria:

* Patients who underwent spine surgery
* Not willing or not able to sign informed consent
* In patients not willing or not able to participate, the reason for denial will be recorded for future evaluation.
Vigamox Treatment for Ocular Graft-Versus-Host Disease

In this study the investigators seek to prospectively measure the response of ocular graft-versus-host disease (GVHD) patients to treatment with topical Vigamox. The investigators will accomplish this by enrolling patients with bilateral ocular GVHD and treating one eye with topical Vigamox and the other eye with a placebo eye drop. By assessing the response to treatment with Vigamox, the investigators hope to identify a role for topical antibiotic treatment in ocular GVHD.


Eligibility Criteria:
Inclusion Criteria:

-Participants will be adults with a history of allogeneic hematopoietic stem cell transplantation, signs of either acute or chronic GVHD per the hematologist, signs and symptoms consistent with ocular GVHD + within 4 months of developing symptoms of ocular GVHD

Exclusion Criteria:

* Treated with antibiotic eye drops in the month prior to enrollment
* History of fluoroquinolone allergy
* Asymmetric ocular disease
* Pregnant
* Nursing
Ambulation Study in Multiple Sclerosis

This is a study comparing clinical tests of walking and balance. The goal of this study is to discover which of those tests are best at predicting walking problems due to MS.

This study includes:

Three study visits to the MS Center at Evergreen; wearing a pedometer for two, one-week periods to record walking during regular daily activities; keeping a diary for any walking problems such as falls and slips.

Subjects must meet the following criteria:

Diagnosis of MS (any form); 18-70 years of age; be on stable MS treatment OR no MS treatment for the last three months; no scheduled hospitalization in the next six months.

Eligibility Criteria:
Inclusion Criteria:

* Subject must have sufficient cognitive ability to maintain a falls diary and follow instructions for wearing the pedometer
* Subject must have clinically definite MS according to McDonald criteria
* Subject must have EDSS between 0-6.5
* Subject must be aged 18-70
* Subjects must be given informed consent
* Subjects must be stable on disease modifying therapy or no therapy for at least three months before entry into study

Exclusion Criteria:

* No MS relapse within the last 30 days
* Subjects must have no scheduled major hospitalizations or surgical procedures during the study time frame. Hospitalization during the study may result in removal from the study
* Medical conditions other than MS that might significantly impact ambulatory activity (such as angina pectoris) in the judgement of the investigators
* History or suspicion of non-compliance in the judgement of the investigators