cyrilzakka/clinical-trials huggingface dataset:
The Influence of High Heeled Shoes on the Sagittal Balance of the Spine and Whole Body

The purpose of this study is to investigate the influence of high heeled shoes on the sagittal balance of the spine and the whole body.

The investigators hypothesize that wearing high heeled shoes leads to a hyperlordosis of the cervical spine, a decrease of thoracic kyphosis, hyperlordosis of the lumbar spine and a posterior tilt of the pelvis resulting in a posterior shift of the body's center of gravity. This would be an explanation for the increased prevalence of back pain in individuals frequently wearing high heels.

In order to assess these changes, differences in the two following outcome parameters will be measured on a standing lateral EOS-radiograph of the whole body - barefoot and with high heeled shoes: spino-sacral angle (primary) and meatus plumb line (secondary) .

Female volunteers (age ≥ 21 years) that are not frequent user of high heeled shoes (i.e. not longer than 6 hours/month with heels \> 3 cm) will be included. Exclusion criteria are osseous metastases, missing written informed consent, cognitive inability to consent on their own, and pregnancy. Based on own preliminary studies, a sample size of 19 (+3 to anticipate drop outs) patients is aimed for.

After obtaining informed consent, the participants will be interviewed with special regard to their age, gender, height, weight, shoe size, past medical history, occupational and recreational activities, and duration and frequency of wearing high heeled shoes.

A clinical examination of the spine and pelvis will be performed as well as a pregnancy urine test.

Standing lateral EOS-radiographs (http://www.eos-imaging.com/) of the whole body will be taken - once barefoot and once with high heeled shoes (heel height 9 cm).

All data acquisition is going to be performed during a single session, participants will not be followed up.

The following parameters will be assessed on the radiographs: presence and number of (healed) fractures, osseous metastases, sagittal C7 plumb line, meatus plumb line, cervical lordosis, thoracic kyphosis, lumbar lordosis, spino- sacral angle as described by Roussouly et al. (2006), pelvic incidence, pelvic tilt.

For statistical analysis, all data will be collected in a statistic software file (SPSS. 21.0, SPSS Inc, Chicago, Illinois). After testing for normal distribution, these differences in means of the primary and secondary outcome parameters between the barefoot and the high heeled radiograph will be assessed using a paired Student's T-test or non-parametric tests. The level of significance is p \< 0.05.

Eligibility Criteria:
Inclusion Criteria:

* not frequent user of high heeled shoes (i.e. not longer than 6 hours/month with heels \> 3 cm)

Exclusion Criteria:

* osseous metastases
* missing written informed consent
* cognitive inability to consent on their own
* pregnancy
Pulsed Electromagnetic Field Stimulation and Charcot Foot Ulcer

thirty-four patients with charcot foot ulcer will be included, their ages will be ranged from 50 to 70 years old and randomly distributed into two equal groups : study group includes 17 patients who will recieve pulsed electromagnetic field and electrical stimulation three days per week for three months .

control group includes 17 patients who will recieve electrical stimulation , standard wound care and medical treatment


Eligibility Criteria:
Inclusion Criteria:

* age ranges between 50 and 70 years old male and female patients all patients with charcot foot ulcer

Exclusion Criteria:

* presence of malignancy hypotensive patients pregnancy immunological and rheumatological disorders
Oral Cromolyn Sodium for the Treatment of Eosinophilic Esophagitis

This is a randomized, double-blind, placebo-controlled study of oral cromolyn sodium when made into a viscous preparation for the treatment of eosinophilic esophagitis.

Eosinophilic esophagitis is an antigen-mediated allergic disease of the esophagus characterized by symptoms of gastrointestinal complaints and eosinophilic inflammation limited to the esophagus. Currently, first line therapeutic recommendations include swallowed, topical steroids or dietary therapy. While both work for the majority of patients, they both have limitations.

The investigators are examining the use of oral cromolyn sodium as a treatment for this condition. This medication is a non-steroid that is already approved for other conditions. When taken orally, it is essentially not absorbed systemically, so side effects are minimal. There is only 1 brief, retrospective report of its use in this condition suggesting it does not work. However, from studying swallowed, topical steroids, it may require formulating the medication into a viscous preparation for it to work.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of eosinophilic esophagitis

Exclusion Criteria:

* Concomitant treatment with swallowed corticosteroids. Any prior use of swallowed corticosteroids will require a 4 week washout period.
* Pregnancy (all females of child bearing potential will have urine pregnancy test done at baseline).
* Evidence of pathologic eosinophilia in other locations in the GI tract.
* Participation in another research protocol
* Reduced Renal or Hepatic Function (all subjects will have a baseline creatinine and liver function panel drawn)
Quality of Life in Pediatric Patients with Acute Lymphoblastic Leukemia Receiving Maintenance Chemotherapy

The purpose of the study is to evaluate the impact of exercise on physical activity levels and quality of life in children with acute lymphoblastic leukemia (ALL) receiving maintenance chemotherapy.

Health-related quality of life is an important outcome of cancer treatment which encompasses physical, psychological, social, and functional well-being. In addition, quality of life includes one's overall ability to become a productive member of society and achieve personal fulfillment. Treatment of pediatric cancer is a highly stressful experience which can be challenging and disruptive to the lives of children and their families. Pediatric oncology patients receiving chemotherapy often experience a decline in quality of life due to decreased activity, fatigue, and psychological distress such as depression or anxiety when compared to healthy individuals. Preliminary data suggests that there is an association between physical activity and quality of life. Exercise has been show to improve mood, increase energy levels, and reduce stress. Although more research and clinical resources have been given to the effects of exercise on quality of life among adult cancer patients, there is a lack of research in these areas among children with cancer. The investigators know little about whether children with cancer would benefit from exercise.

The investigators have added a blood sample for biomarkers. Research in adult cancer patients have shown an association between different biomarkers and sleep quality which suggests that regulation of certain biomarkers may be affected through exercise in adults. Measures of biomarkers may provide insight into potential mediators between PA, sleep quality, or fatigue levels.

Eligibility Criteria:
Inclusion Criteria:

* Pediatric oncology patients with ALL in the maintenance phase of chemotherapy during the time of study
* Ages 8-18 years of either gender (age limits due to reliability and validity of outcome assessment surveys)
* Have no documented or observable psychiatric or neurological disorders that would interfere with study participation
* Capable of speaking and reading English
* Having no contraindications to participate in moderate physical exercise as determined by the research staff and the patient's pediatric oncologist
* Currently living with their parents/legal guardians
* Consent obtained from legal guardians and assent obtained from patients to participate in the study

Exclusion Criteria:

* Not a pediatric oncology patient with ALL in maintenance
* Not receiving chemotherapy during the time of study
* Age less than 8 years or greater than 18 years
* Not English-speaking Since not all outcome measures have been validated in Spanish and other languages, only English-speaking patients will be included.
Seroma and Hematoma Rates: MAXIGESIC IV vs. Ketorolac in Breast Cancer Surgery

The investigators aim to compare the incidence rates of seroma (fluid collection) and hematoma (blood clot) following breast cancer surgery between the conventional non-steroidal anti-inflammatory drug (NSAID) Ketorolac and MAXIGESIC. The investigators seek to determine the complication rates in patients receiving MAXIGESIC post-surgery, hypothesizing that the higher dosage of ibuprofen in MAXIGESIC compared to Ketorolac will result in lower complication rates.


Eligibility Criteria:
Inclusion Criteria:

* Systemic performance status 0-2 according to ECOG criteria
* Patients with adequate renal function: serum Cr 1.4 mg/dL or less
* Patients with adequate liver function Bilirubin, AST/ALT: 1.5 times or less of the upper limit of normal, Alkaline phosphatase: 1.8 times or less of the upper limit of normal
* Patients undergoing total mastectomy with SLNB or ALND (mastectomy and axillary sentinel lymph node dissection)
* Patients undergoing breast-conserving surgery with ALND (mastectomy and axillary dissection)
* Patients who voluntarily decided to participate in this study and signed a written informed consent form

Exclusion Criteria:

* Patients undergoing immediate reconstruction operation
* Patients with drug allergies to painkillers and anti-inflammatory drugs
* Patients with a physical condition that would interfere with understanding and submitting the consent form
Comparison of Bone Effects With Copaxone and Interferon in Multiple Sclerosis

The purpose of this study is to determine if certain drugs commonly used to treat multiple sclerosis have an effect on bone health.

There will be 60 female patients with MS at University of Kansas Medical Center (KUMC). They will be split into two groups: a Copaxone group and an Interferon (Avonex, Rebif, or Betaseron) group. Each group will be composed of 30 women matched for menopausal status. Each subject will be given a questionnaire assessing risk factors for low bone density. All patients will have a determination of an Expanded Disability Status Scale (EDSS), height and weight, medical history, and fracture history. All patients will undergo hip and spine dual x-ray absorptiometry (DEXA) and will have labs drawn to determine serum 25 hydroxyvitamin D, parathyroid hormone, ionized calcium, estradiol, bone-specific acetyl phosphatase, osteocalcin, and C-peptides.

Eligibility Criteria:
Inclusion Criteria:

* Female, age \> 18
* Able to understand and give informed consent
* Relapsing remitting multiple sclerosis (RRMS)
* Treatment with interferons or Copaxone for at least one year prior to study entry

Exclusion Criteria:

* Known osteoporosis
* History of hypercalcemia
* Currently pregnant
* History of primary hyperparathyroidism, hyperthyroidism, or hypothyroidism
* Unstable medical condition
* Ongoing use of bisphosphonates
Effect of Sugar-Free Chewing Gum Containing Tulsi Extract on Salivary Streptococcus Mutans in a Group of Children

The goal of this clinical trial was to explore how adding Tulsi extract, a natural plant substance, to chewing gum affects the levels of Streptococcus mutans, type of bacteria that cause dental caries, in the saliva of children aged 4 to 11 years. Participants should not use removable prosthetics or orthodontic appliances and had had not used antibiotics in the 2 weeks preceding sample collection.

We want to answer this main question:

Can chewing gum with Tulsi extract significantly reduce the number of Streptococcus mutans bacteria in children's saliva?

Participants tasks:

* Children were asked to chew gum containing Tulsi extract for 5 minutes and then dispose of the gum.
* Two salivary samples were collected from each child: one before gum chewing and another 30 minutes after disposing the gum.

Researchers compared Streptococcus mutans counts in saliva before and after gum chewing to determine if there is a significant reduction in bacterial colonies.

This interventional clinical trial aimed to assess the antimicrobial effect of Tulsi extract incorporated into chewing gum on the salivary Streptococcus mutans count in a group of children aged 4 to 11 years. The study enrolled 32 systemically healthy children who met specific criteria, including the absence of removable prosthetics or orthodontic appliances and no recent history of antibiotic use in the preceding 2 weeks.

Participants and Methods:

A sample of 33 children within the age range of 4 to 11 years was selected. The participants were systemically healthy, without removable prosthetics or orthodontic appliances, and had no recent history of antibiotic use in the previous 2 weeks. To standardize saliva collection conditions, samples were collected between 9-10 am in the morning. Children were instructed not to eat or drink anything (except water) 1 hour before saliva collection to maintain consistency in the samples.

Participants were then asked to spit into sterile containers as the method of saliva collection. Subsequently, they were instructed to masticate gum containing Tulsi extract for a duration of 5 minutes and discard the gum.

Two salivary samples were collected from each participant: one before commencing gum chewing and another 30 minutes after the conclusion of chewing gum for 5 minutes. The samples were streaked onto mitis salivarius agar plates and incubated at 37°C for 24 hours. Streptococcus mutans colonies were then counted to assess the change in bacterial count.

Eligibility Criteria:
Inclusion Criteria:

1. Children aged between 4 and 12 years old.
2. No fixed or removable orthodontic appliances or removable prostheses.
3. Systemically healthy patients.
4. No history of recent antibiotic administration (previous 2 weeks).

Exclusion Criteria:

1. History of using antimicrobial mouthwash (previous 12 hours).
2. History of fluoride treatment (previous 2 weeks).
Effectiveness of C-MAC Video-stylet Versus Fiberoptic Bronchoscope for Awake Intubation

C-MAC- Video Stylet is a completely new type of video endoscope. It combines the advantages of both rigid and flexible intubation endoscopes.

C-MAC-VS can be connected easily to the same C- MAC monitor and Pocket Monitor without requiring any additional light source and camera. This device is great for cases with limited mouth opening, airway obstruction and difficult intubation.

Eligibility Criteria:
Inclusion Criteria:

* patients with BMI ≥ 30 kg/m2,
* presence of any predictors of difficult intubation;
* Mallampati score \> =3;
* inter-incisor distance \< 3 cm;
* thyromental distance \< 6 cm;
* neck extension \< 80°from neck flexion;
* cervical spine instability;
* history of difficult endotracheal intubation or difficult mask ventilation

Exclusion Criteria:

* patients have increased risk of pulmonary aspiration;
* have significant medical diseases in term of cardiac, respiratory, hepatic, renal,
Colorectal Polyp Discrimination Using High-Definition Narrow Band Imaging

The investigators seek to compare the accuracy of the existing colonoscope model to determine the magnitude of the improvement the investigators can expect in polyp discrimination as neoplastic or non-neoplastic.

Information will be collected. Images will be taken.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 and older
* Presenting for surveillance, screening or diagnostic colonoscopy
* Willingness to provide informed consent

Exclusion Criteria:

* Inability to provided informed consent
* Pregnancy
* Known inflammatory bowel disease
* Personal or family history of polyposis or nonpolyposis syndrome
* Emergency colonoscopy/endoscopy
* Coagulopathy or thrombocytopenia preventing polypectomy
* Procedure indication for acute bleeding or active colitis
Bilateral Endoscopic Thoracic T3 Sympathectomy Versus T3 Radiofrequency Ablation for Primary Palmar Hyperhidrosis

Primary hyperhidrosis disease is characterized by much more sweating above the needs for thermoregulation, which is worsen by increased temperature and emotional factors it can be seen in the palms of the hands, soles of the feet/ face and so on.

Hyperhidrosis usually starts since childhood and continuous throughout life aggravated by emotional stress or by high environmental temperature.

Many lines of treatment were tried such as anticholinergic drug, physiotherapy. Endoscope thoracic sympathectomy and radio frequency with phenol injection.

Interruption of intrathoracic sympathetic neural pathway surgically to treat hyperhidrosis by using video - thoracoscopy which has lead to explosion of minimally invasive technique for this issue. It's safe procedure and success rate in about 95% so it's result in this disease are rewarding.

Other technique will be studied in this current study is radiofrequency ablation it may be a good option for treatment of primary hyperhidrosis. When endoscope is not allowed.

An early outcome is our primary target for comparing the two different techniques.

Treatment with radiofrequency can benefit patients specially young one because a lot of them refuse endoscopic sympathectomy with its special anesthetic consideration as one lung ventilation and sometimes patient left with intercostal tube for some days so it's considered difficult procedure and much more easy is radiofrequency but alone the results is not satisfactory so in this clinical trial endoscopic sympathectomy will be compared with radiofrequency ablation regarding to the early outcome for the two procedure in this clinical trial interruption of sympathetic chain was chosen at the level of T3 because at this level interruption involve only the sympathetic chain without any ganglion damage or compensatory sweating which was seen when the interruption of the level of T4.

Eligibility Criteria:
Inclusion Criteria:

* Patients with primary palmar hyperhydrosis.
* Patients with American society classification 1 and 2.

Exclusion Criteria:

* Patient refusal.
* Previous sympathectomy either endoscopic or by radiofrequency.
* Previous sternotomy operation.
A Study to Assess the Efficacy and Safety of OBE2109 in Subjects With Endometriosis

The primary objective of this study is to assess the efficacy and safety of a range of oral doses of OBE2109 versus placebo, in reducing endometriosis associated pain.

The study is a prospective, dose-finding, randomized, parallel group, double-blind, placebo-controlled phase 2b study investigating the efficacy and safety of OBE2109 in the treatment of 330 women with moderate-to-severe endometriosis associated pain.

Subject will be randomized to one of 6 treatment groups in a 1:1:1:1:1:1 ratio (1 placebo group, 5 dose groups with different dosage/regimen).

Eligible subjects will be offered the opportunity to continue treatment with OBE2109 in an extension phase. Subjects who do not continue in the extension will enter the treatment-free follow-up phase of the study.

Eligibility Criteria:
Key Inclusion Criteria:

* The subject must have had her most recent surgical and - if available - histological, diagnosis of pelvic endometriosis up to 10 years before screening.
* The subject has moderate to severe endometriosis-associated pain during the screening period.
* The subject has regular menstrual cycles.
* The subject has a BMI ≥ 18 kg/m2 at the screening visit.

Key Exclusion Criteria:

* The subject is pregnant or breast feeding or is planning a pregnancy within the duration of the treatment period of the study.
* The subject had an interventional surgery for endometriosis performed within a period of 60 days before screening.
* The subject did not respond to prior treatment with gonadotropin releasing hormone (GnRH) agonists or GnRH antagonists for endometriosis.
* The subject has a history of, or known osteoporosis or other metabolic bone disease.
* The subject has chronic pelvic pain that is not caused by endometriosis and requires chronic analgesic / therapy, or that would interfere with the assessment of endometriosis related pain.
The Presence and Role of Zygomatic-temporal Neuroma Triggering Cluster Headache

Role of a neuroma of zygomatic-temporal in triggering of a cluster headache. Exploratory diagnosis, resection, and pathological examination of tumor anticipated

.

An anatomical coordinated communication of a Cluster Circuit turned on by Zygomatico-Temporal neuroma, a malicious possibly nontraumatic, neoplastic tissue coding and decoding itself upon autonomic release of neurotransmitter(s). Exhaustion of neurotransmitter synthesis turns out the explosions of pain-symptoms off.

Poor attention to the characterization of a peripheral neuroma of trigeminal nerve branch deranged attention to central(CNS) characterization of Cluster Symptoms.

This study based on our experimental results of minimal surgical procedure to explore, diagnose and resect a Zygomatico-Temporal neuroma in the temple of patients suffering from EpisodicChronic, Cluster Headache-ECCH. The goal is to light on this speculation in a novel analysis of events to put an end to devastating catastrophic headaches. Detailed anatomical components loci of the autonomic symptoms in the cluster headache reveal the presence of an electrical neural circuit.

The extracranial circuit components of ECCH reflects the anatomical nerve components participating reflection of the single circumscribed symptom:

1. Zygomatico-Temporal-neuroma
2. Zygomatic nerve V-II
3. Intraorbital communicants rami
4. Lacrimal nerve V-I
5. Ophthalmic nerve Intraorbital routing, supraorbital nerves, the upper eyelid, the conjunctiva and cornea of the eye, the nose (including the tip of the nose, except alae nasi), the nasal mucosa, the frontal sinuses. V-I
6. Optic nerve via ophthalmic nerve routing and electricity propagation.
7. Pterygopalatine ganglion as peripheral and CNS coordinator center.

An intracranial CNS reaction follows in response to the perception of pain materialized in neuroimaging during the activity of ECCH.

Eligibility Criteria:
Inclusion Criteria:

- Cluster headache

Exclusion Criteria:

* Malignant hypertension,
* Brain tumors,
* Cerebral vascular abnormalities,
* Presence of a brain or nerve electro stimulator.
Ultrasound Paravertebral Block in Breast Surgery.

The purpouse of the study is to determine wether Ultrasound Guided,Ens-assisted paravertebral block with single shot is a safe and reliable anesthetic technique in breast surgery.

General anaesthesia is currently the conventional technique used for breast surgery. Thoracic Paravertebral block (PVB) has been used with multiple injection.

We compared a single injection thoracic PVB with general anaesthesia (GA) in 20 consenting patients, scheduled for unilateral breast surgery.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists classification I-III
* Written informed consent
* Age older than 18 years old

Exclusion Criteria:

* allergy to local anesthetics
* local sepsis