cyrilzakka/clinical-trials huggingface dataset:
Botulinum Toxin in the Treatment of Gingival Smile

Objective: to evaluate the effect of two gingival smile treatment techniques using botulinum toxin. Materials and methods: The randomized, double-blind clinical trial (patient and examiner) will be conducted by two trained and calibrated dentists. Ten patients will be randomly assigned to each group, in a total of 20 patients with gingiva smile greater than or equal to 3mm. In group 1, 10 patients will receive 2 units/point of botulinum toxin Botulift® (botulinum toxin type A), in the muscles form the face: Levators labii superioris alaeque nasi muscle and Levators labii superioris muscle, totalizing 4 points. In group 2, 2 units/point was injected in the muscles: levators labii superioris alaeque nasi muscle, totalizing 2 points. The amount of exposed gingiva during smile will be measured using a pachymeter and the muscle activity of the region will be evaluated through electromyography, before and after treatment (2, 8, 12, 21 and 25 weeks). Patient satisfaction and discomfort due to treatment will be evaluated in the same periods through questionnaire. The impact of the treatment in life quality will be evaluated through OHIP-14 questionnaire.


Eligibility Criteria:
Inclusion Criteria:

1. Patients of both genders exhibiting gingival exposure greater than or equal to 3 mm above the central incisor during smile
2. Patients with good general health and good oral hygiene.

Exclusion Criteria:

1. Patients with Botulinum Toxin allergy or albumin, or who have previously performed botulinum toxin facial treatment previously.
2. Patients with Amyotrophic Lateral Sclerosis, Neuropathy, Myasthenia Gravis or Lambert-Eaton Syndrome, women who are pregnant or planning to become pregnant, are breastfeeding women.
3. Patients who are participating in other research involving other drugs.
4. Patients who use drugs that interfere with neuromuscular transmission
Development of Preterm Infant Gut Microbiome

This study aims to explore the developmental of the gut microbiome in preterm infants as they grow and mature

Preterm birth, defined as childbirth occurring at less than 37 completed weeks, is a major determinant of neonatal mortality and morbidity and has long-term adverse consequences for health. The human microbiome is the collective genome of the immense ecosystem of trillions of microbes and is considered to have a coevolved relationship with the immune system and fundamental roles in multiple aspects of human physiology. Little is known about the developmental of the gut microbiome in preterm infants as they grow and mature.

One hundred premature infants born in Rambam healthcare campus in Haifa, Israel, will be recruited to the study and 100 term healthy infants will be recruited as controls. Infants born before 24 weeks of gestation or have birth weights of less than 400 g and infants with severe congenital anomalies will be excluded from the study. Fecal samples will be collected during the hospital stay and in follow-up visits. Blood samples will be taken during the hospital stay. The investigators will analyze the data from this clinical cohort using computational and experimental approaches for extracting novel information on microbiome composition and development, gene function, metabolic pathways and metabolite production.

Eligibility Criteria:
Inclusion Criteria:

* Premature and term infants born in Rambam healthcare campus in Haifa, Israel

Exclusion Criteria:

* Infants born before 24 weeks of gestation or have birth weights of less than 400 g and infants with severe congenital anomalies will be excluded from the study.
The Effectiveness of Acupuncture Therapy on Pain in Parkinson's Disease

Parkinson's Disease (PD) is a chronic, progressive, degenerative movement disorder that is characterized by motor and nonmotor symptoms and its incidence increases with age. It has been reported that 40-90% of patients have pain symptoms in PD. Pain can be the result of motor fluctuations, dystonic muscle contractions, deep visceral pain, and musculoskeletal pain.

Parkinson's Disease (PD) is a chronic, progressive, degenerative movement disorder that is characterized by motor and nonmotor symptoms and its incidence increases with age. It is the second most common neurodegenerative disease after Alzheimer's.Bradykinesia, which is characterized by rigidity, resting tremor, postural instability, gait disturbance and progressive decrease in the speed and amplitude of repetitive movements throughout the course of the disease, are the main cardinal motor findings.Sensory dysfunction such as non-motor findings in PD, disruption in the sleep-wake cycle, neuropsychiatric findings such as dementia, confusion, hallucinations, delirium, depression, gastrointestinal dysfunction, autonomic nervous system disorders such as bladder dysfunction, orthostatic hypotension, and pain perception may develop.Although dopaminergic therapies in PD are the gold standard in the treatment of disorders such as bradykinesia, rigidity and tremor, adequate response cannot be obtained in the treatment of non-motor symptoms. For this reason, rehabilitative applications, especially pain symptom, and complementary medicine methods are very important.It has been reported that 40-90% of patients have pain symptoms in PD. Pain can be the result of motor fluctuations, dystonic muscle contractions, deep visceral pain, and musculoskeletal pain.

Acupuncture and dry needling therapy have been used clinically for a long time as pain relievers such as migraine pain, low back pain, chronic pain and cancer pain. On the other hand, there are very limited and very limited number of studies on the efficacy of dry needle therapy applied to acupuncture points in pain control in PD.In this study, our aim is to investigate the effectiveness of dry needling treatment applied to acupuncture points in neck pain due to PH on musculoskeletal pains.

Eligibility Criteria:
Inclusion Criteria:

* Being Parkinson's Disease
* Age 45-75
* Have a pain due to Parkinson's Disease

Exclusion Criteria:

* Presence of advanced dementia or mental disability
* Pain due to ınflammatory conditions
* Using anticoagulant therapy
Spinal Anesthesia With Hyperbaric Levobupivacaine 0.75% for Ambulatory Knee Arthroscopy

The purpose of this study is to evaluate motor block probability throughout time and clinical profile when using three different doses of HLBP 0.75% (7.5, 9.37 and 11.25 mg) by a unilateral spinal block technique.

Previous IRB approval and informed consent, 180 ASA I-II adults under ambulatory knee arthroscopy will be randomly allocated to receive unilateral spinal anesthesia with 7.5 (group Levo-7.5, n=59), 9.37(group Levo-9.37, n=61) and 11.25 (group Levo-11.25, n=60) mg of HLBP 0.75% using a 27-gauge Whitacre needle at a rate of 0.1 ml/ seg. and lateral decubitus position maintained for 5 min after injection.

An independent observer will evaluate motor (modified Bromage scale) and sensory (transcutaneal electrical stimulation at T10, L1, L3, and S1 dermal segments) levels and presence of adverse events immediately after return to supine, at the end of surgery and each 10 min from admission to PACU until home discharge conditions.

Trans-cutaneal electrical stimulation (TES) will be made with a PNS (Ministim® model MS- IV, Organon, Dublin, Irland) using 50-Hz tetanus stimuli for 5 seg. from 10 to 60 mA 3,4.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-64 y.o. scheduled for knee arthroscopy (therapeutic or diagnostic)

Exclusion Criteria:

* Cardiac or pulmonary disease
* Antiplatelet or anticoagulant drugs use during 7 days before surgery
* History of coagulative disorders
* Bilateral procedures
Testosterone Replacement Therapy in Chronic Spinal Cord Injury

It has long been recognized that co-morbidity associated with multiple metabolic syndrome, such as adverse body composition, insulin resistance and autonomic nervous system impairment, may lead to significant increase in cardiovascular morbidity and mortality. It is unclear whether the co-morbidity evident in this population are due directly to their immobility or are the result of unfavorable changes in their underlying hormonal milieu. The purpose of this study is to determine the effect of testosterone replacement therapy in hypogonadal males on:

body composition, i.e. lean tissue and fat mass, glucose tolerance, resting energy expenditure, autonomic-cardiovascular integrity, muscular strength, psychological assessment

This study is 24 months in duration. Men who have consented to pre-screening serum testosterone draw and are found to have total testosterone levels averaging ≤ 11.3 nmol/l will start testosterone replacement therapy after a 6-month baseline period. Once treatment begins subjects will place a testosterone replacement patch (5 or 10 mg/day) on various sites of the body daily. Subjects will visit the lab after 2,6, 12, and 18 months of therapy for testing; however they will stop taking the patch at the 12 month visit. If needed, a steroid cream will be provided to the subjects should any skin irritations occur. If the patch causes persistent skin irritations, despite use of the steroid cream, then a testosterone gel may be used. Detailed instructions and precautions using the gel are outlined in the consent form and will be reviewed with the subject.

Those men who have consented to pre-screening serum testosterone and are found to have normal levels of total testosterone (testosterone total ≥ 11.4 nmol/l) are eligible to participate as a control subject for the full 24-month period of the study. These subjects visit the lab at baseline (BL), 12 and 24 months for the same testing as those in the treatment group.

Eligibility Criteria:
Inclusion Criteria:

* Males 18-49 years of age
* Chronic spinal cord injury
* Normal prostate specific antigen levels and digital rectal exam
* No known cardiovascular disease
* Subjects with total testosterone \> 4 ng/ml
* Subjects with total testosterone \> 4 ng/ml

Exclusion Criteria:

* Females
* Known coronary heart and/or artery disease, diabetes mellitus
* Previous or current cancer
* Current or previous anabolic steroid use
* Acute inter-current illness
* Abnormal liver function test (\>1.5 times normal values) at baseline
* Prostate specific antigen above normal
* Abnormal digital rectal exam at baseline suggestive of malignancy
* Current alcohol or drug abuse
* Significant psychological disorders
Effect of High Protein, High-calorie Oral Nutritional Supplementation in Malnourished Elderly in Nursing Homes.

The hypothesis of this study is that the administration of a high-calorie high-protein oral nutritional supplement twice a day for three months to elderly malnourished in residents in Spain is associated with improved nutritional status, with an increase in body weight of between 5 and 8%, and an improvement in functional status, with low incidence of complication.

A prospective, multi centric, observational study. The study is conducted in elderly living in nursing homes in Spain.

Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 65 years,
* Living in nursing homes,
* Malnutrition treated with an hyper-caloric oral nutritional supplementation (1.3 Kcal / ml) and high-protein (protein 20%).

Exclusion Criteria:

* Tube feeding (nasogastric or gastrostomy)
* Terminally ill or palliative treatment and residents with life expectancy of less than 6 months
* Special nutritional requirements (for example by intestinal malabsorption, short bowel residents or specific nutrition for renal insufficiency).
Biomarkers in Prehospital Prediction of Need for Neurosurgical Observation or Intervention in TBI Patients

The PreTBI II study aims to investigate the diagnostic potential of prehospital S100B and GFAP measurements in prediction of need for neurosurgical observation and/or intervention in moderate TBI patients, to rule-in high-risk patients. Ultimately to select patients who will benefit from neuro surgical expertise in specialized departments and thereby possibly better patient outcome. Hopefully also minimize treatment delay, secure optimal resource consumption and streamline patient courses by predicting the presence of neurotrauma.

Hypotheses:

1. A prehospital serum S100B level \> 0,10 microgram/L and expectedly above a certain and currently unknown cut-off value indicates the need for neurosurgical observation and/or intervention in moderate TBI patients.
2. A prehospital serum GFAP level above a certain and currently unknown cut-off value can significantly predict a need for urgent neurosurgical observation and/or intervention in moderate TBI patients.
3. Biomarker dynamics between prehospital and in-hospital biomarker values of S100B and GFAP can significantly predict a need for urgent neurosurgical observation and/or intervention.
4. Biomarker dynamics between prehospital and in-hospital biomarker values of S100B and GFAP can significantly predict hospital course and outcome of patients with moderate TBI.


Eligibility Criteria:
Inclusion Criteria:

* Patients presenting with Glasgow Coma Score (GCS) GCS 9-13 suffering relevant trauma and displaying relevant clinical indices compatible with TBI as evaluated by EMS staff. Patients are considered incompetent due to on-going alteration of mental state.

Exclusion Criteria:

* Patients \<18 years, GCS \<9, \>6 hours elapsed after trauma, unknown time of trauma, multi trauma, known dementia, chronic psychosis or active central nervous system (CNS) pathology.
Virtual Reality-Based Exercise in Cancer Patients

The aim of the present study is to evaluate an innovative virtual reality-based balance training intervention for improving clinically relevant motor performances (balance and gait) in cancer patients.

The investigators hypothesize that the virtual reality-based balance training intervention will improve balance and gait performances in cancer patients compared to a control group receiving usual care only.


Eligibility Criteria:
Inclusion Criteria:

* ability to ambulate without assistance
* willingness to provide informed consent
* cancer
* neuropathy related to chemotherapy

Exclusion Criteria:

* severe neurologic, cardiovascular, metabolic, or psychiatric disorders
* severe visual impairment
* cognitive impairment
Improving Female Sexual Wellness

The purpose of this study is to assess the effect of commercially available genital vibrator use on sexual health, female pelvic floor disorders, and overall quality of life among a diverse population of women.


Eligibility Criteria:
Inclusion Criteria:

* English speaking
* Diagnosis of female sexual dysfunction, pelvic floor dysfunction, genito-urologic issues (stress urinary incontinence, urge urinary incontinence, pelvic organ prolapse, interstitial cystitis, pelvic pain, dyspareunia, lichen sclerosis)
* Manual dexterity to use vibrator

Exclusion Criteria:

* Non English speaking
* Pregnancy or \<12 months postpartum
* Poor manual dexterity
Ablative Fractional Lasers to Treat Peri-orbital Rhytides

Ablative fractional lasers were introduced for treating facial rhytides in an attempt to achieve results comparable to traditional ablative resurfacing but with fewer side effects. However, there is conflicting evidence on how well this goal has generally been achieved as well as on the comparative value of fractional CO2 and Er:YAG lasers. The present study compares these modalities in a randomized controlled blinded split-face study design:

28 patients were enrolled and completed the entire study. Patients were randomly assigned to receive a single treatment on each side of the peri-orbital region, one with a fractional CO2 and one with a fractional Er:YAG laser. The evaluation included Fitzpatrick wrinkle score, profilometric measurement of wrinkle depth (both before and 3 months after treatment) as well as assessment of side effects and patient satisfaction (1, 3, 6 days and 3 months after treatment).


Eligibility Criteria:
Inclusion Criteria:

* age 40-55
* mild to moderate peri-orbital rhytides

Exclusion Criteria:

* unrealistic expectations
* inability to meet follow-up criteria
* Fitzpatrick skin phototype \>III
* coagulation disorders or anti-coagulant treatment
* allergy to lidocaine or tetracaine
* oral isotretinoin within the last 6 months
* any active skin disease within the treatment areas (e. g., cancer, autoimmune disease)
* synthetic implants in the treatment area
* facial cosmetic procedures affecting the treatment area within the last 6 months
* photosensitizing medications (e. g., tetracycline, gold)
* history of keloid formation
* pregnancy
Development of a Non-invasive Assessment of Skeletal Muscle Loss in Cancer Patients

The long-term objective of this research is to develop a non-invasive approach for early assessment of which patients are at high risk for future development of skeletal muscle atrophy. The investigators hypothesize that the rate constant for the terminal portion of the isotope decay curve following ingestion of a single oral dose of deuterated-3-methylhistidine (D-3MH) provides an accurate measure of this increased risk and that this rate constant can be measured non-invasively from timed spot urine samples. In addition, the investigators hypothesize that ingestion of a meat-containing meal will stimulate synthesis of skeletal muscle proteins to a greater extent than a non-meat-containing meal.


Eligibility Criteria:
Inclusion Criteria:

* male
* 30-85 years
* Body Mass Index (BMI) \<30 kg/m2

Exclusion Criteria:

* Uncontrolled hypertension
* Glomerular filtration rate less than 60 mL/min/1.73 m2
* History of recurrent gastrointestinal bleeding
* Unable or unwilling to provide informed consent
* Ongoing anti-coagulant therapy
Caudal Epidural Block Versus Ultrasound-Guided Pudendal Nerve Block for Pediatric Circumcision

The regional anesthesia methods of caudal epidural block (CEB) and dorsal penile nerve block (DPNB) play an important role in providing postoperative pain control in pediatric circumcision surgery. However, the short-term postoperative analgesic effect and the risk of block failure limit the use of DPNB, a peripheral nerve block.

CEB is a neuraxial block and commonly used to control moderate and severe postoperative pain following surgery related to the lumbosacral and midthoracic dermatomes. CEB can have serious undesirable complications such as intravascular and subarachnoid injection, urinary retention and motor block. Pudendal nerve block can be used as an alternative to both DPNB and CEB for penile surgery such as circumcision. The pudendal nerve is a peripheral nerve combining the anterior rami of the sacral plexus nerves (S2-S4) and provides motor and sensory innervation to the perineal region.

Eligibility Criteria:
Inclusion Criteria:

* Male patients aged between 4-12 years
* ASA (American Society of Anesthesiologists) I-II group
* Scheduled for circumcision
* Able to communicate in Turkish
* Willing to participate to the study (parents and children)

Exclusion Criteria:

* Patients aged less than 4 or more than 12 years
* Neurological deficit
* Bleeding diathesis
* History of local anesthetic allergy
* Current infection or redness in the region to be injected
* Congenital lower back anomaly
* Liver disease
* Psychiatric disorder
* Mental retardation
* Communication problem
* Refusal to participate in the study.
Study of ISB 1302 (CD3 Bispecific Ab) in HER2-positive Metastatic Breast Cancer

The purpose of this study is to determine the safety profile, maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of single agent ISB1302 in subjects with HER2-positive metastatic breast cancer who have been treated with all known therapies known to confer clinical benefit.

To determine the safety profile, maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of single agent ISB 1302 in subjects with HER2-positive metastatic breast cancer who have been treated with all known therapies known to confer clinical benefit.

Eligibility Criteria:
Inclusion Criteria:

* Females with HER2-positive \[IHC 2 +, with FISH confirmation\] or 3+ \[IHC or FISH\] metastatic breast cancer that has progressed on last therapy. No more than 4 lines of therapy in metastatic setting (of which no more than 2 lines should be anti-HER2 antibody-based therapy).
* Measurable disease, defined as per RECIST v1.1.
* Eastern Cooperative Oncology Group (ECOG ) performance-status score of 2 or less
* Adequate bone marrow, renal, and liver function.
* Recovered from any previous surgery and no history of major surgery within the last 28 days prior to start of study drug
* Must be willing to undergo pre-treatment and on-treatment biopsies in Part 1 and Part 2.

Exclusion Criteria:

* Any suspected or proven immunocompromised state, or infections, such as history of positive human immunodeficiency virus (HIV), known active or chronic hepatitis B virus (HBV) or hepatitis C virus (HCV).
* Any history or evidence of clinically significant cardiovascular disease.
* Evidence of clinically significant cardiovascular and respiratory conditions
* Previous antineoplastic treatment with immune checkpoint regulator or comparable immunotherapy within 8 weeks of starting study drug.
* Chemotherapy, radiotherapy, molecular-targeted therapy, or biological therapies (including HER2-directed therapies) within 4 weeks of starting study drug
* Hormone therapy within 2 weeks of starting study medications.
* Diagnosed with another malignancy that requires active therapy
* Brain metastases that require directed therapy.
* Has not recovered from any therapy related toxicities from previous treatments.
* Use of any investigational drug within 4 weeks from the start of study drug.
* Any condition that, in the opinion of the Investigator, would interfere with evaluation of the study drug or interpretation of subject safety or study results.
A Feasibility Study to Assess the Visual Performance and Comfort of Hanita G4 Multifocal Soft Contact Lenses for Presbyopia at Normal Daily Routine Use

The G4 Multi multifocal contact lens is a soft contact lens intended to correct far, intermediate, and near vision for individuals with presbyopia. The lens covers the cornea and part of the sclera. The lenses can be used for daily wear for up to 1 year.

Study Design:

A clinical performance study without a control group to compare the G4Multi contact lens to other approved soft contact lenses for presbyopia

Study Objectives:

1. To assess the multifocal vision in the various ranges of the HANITA G4 Multi.
2. To rate the comfort of the lenses in individuals with presbyopia

Study population:

Healthy men and women above the age of 18 diagnosed with presbyopia who have used contact lenses in the past

Recruitment :

A total of 30 subjects completing at least 1 month of participation.

Eligibility Criteria:
Inclusion Criteria:

1. Presbyopia participants with healthy eyes who are not using any ocular medications, aged 18 years and over and who have used contact lenses in the past
2. Lens powers within the range available for the test lenses
3. Best spectacle-corrected visual acuity equal or greater than 20/25 (less than or equal to Log MAR 0.1)

Exclusion Criteria:

1. Anterior segment infection, inflammation, or abnormality
2. Any active anterior segment ocular disease that would contraindicate contact lens wear
3. The use of systemic or ocular medications that would contraindicate contact lens wear
4. History of herpetic keratitis
5. History of refractive surgery or irregular cornea
6. Slit lamp findings that are more serious than grade 1
7. Corneal vascularization greater than 1 mm of penetration
8. Pathologically dry eye;
9. Participation in a contact lens or contact lens care product clinical trial within the previous 30 days