cyrilzakka/clinical-trials huggingface dataset:
Hypertrophic Myopathy in Children

The purpose of this study is to identify the patients seen in our practice who are seen with Hypertrophic Myopathy diagnosis in order to better understand the presenting characteristics of their disease, the diagnostic testing to determine the diagnosis, the methods used to follow the disease progression and management practices used in caring for these patients. The objectives of this data review will be an analysis to determine if there is a methodology that will foster improved diagnostic speed and accuracy, and determine the best management practices based on outcomes in these patients.

The charts of children followed at Sibley Heart Center of Children's Healthcare of Atlanta will be identified using the Mysis system and screening for the appropriate ICD-9 codes for the types of Hypertrophic Myopathy. These codes include: 425.1, 425.4, 425.7, 425.8, and 425.9. Screening will also be done for known anomalies that are associated with hypertrophic myopathy as seen in some syndromes and metabolic disorders.

Data Collection:

Age at presentation (DOB) History - Prenatal, Family, Current Surgical Procedures Physical Exam results EKG interpretation CXR results Echocardiography results MRI Results Holter monitors results Exercise testing results Radionuclear study results Spiral CT Study results Genetics Testing results Medication usage Enzyme replacement therapy usage Diagnostic laboratory results

Statistics:

A generalized linear model will be performed. Significance will be defined at P≤ 0.05.

Interim monitoring of accumulated data will be performed. One interim analysis will be performed after 3 months of accrual with additional analyses being performed at the end of data collection.

Demographic data will be summarized for all subjects. For each patient summary statistics will include the mean, standard deviation, frequency distribution, minimum, maximum and range.

Eligibility Criteria:
Inclusion Criteria:

* seen at Sibley Heart Center, Children's Healthcare of Atlanta
* diagnosed with Hypertrophic Myopathy

Exclusion Criteria:

* those who do not meet inclusion criteria
Augmentation of Meniscal Repair With Marrow Stimulation Techniques (Microfractures)

This study will compare meniscal healing augmented or without augmentation with bone marrow stimulation techniques The assessments will include validated, disease specific, patient oriented outcome measures, second look arthroscopy during second step ACL reconstruction. Results of this study will help ascertain whether microfractures improve meniscal healing rates.

The role of meniscal in the knee integrity is pivotal and lack or partial role of the meniscus increases rate of joint degeneration. Partial meniscal removal is the most popular procedure and meniscal repair remain in minority of arthroscopic surgeries. As criteria of inclusion to meniscal repair are very rough, still success rates of meniscal repair remain in the 60-80% range for isolated repairs. This rate is greater when performed with ACL reconstruction. We believe that augmentation with bone marrow stimulation techniques will induce more complete and possibly faster healing.

Eligibility Criteria:
Inclusion Criteria:

* Complete vertical longitudinal tear \> 10 mm in length
* Tear located in the vascular portion of the meniscus, only in red-white zone
* Unstable peripheral tear
* Single tear of the medial and/or lateral meniscus
* Meniscal injury 1 -18 month prior surgery
* Planned second step arthroscopy (ACL reconstruction)
* Skeletally mature patients 18-55 years of age

Exclusion Criteria:

* discoid meniscus
* arthritic changes (Kellgren Lawrence scale \>2)
* non repairable meniscus
* degenerative or presence of crystals in meniscus
* concomitant procedure (acl reconstruction, microfracturing, trephination)
* inflammatory diseases (i.e. rheumatoid arthritis)
Comparison of Selective Trunk and Supraclavicular Brachial Plexus Blocks

There are different methods in brachial plexus blocks for hand, wrist, forearm, and elbow operations. In this study, the anesthetic efficacy of the ultrasound-guided selective truncus methods and the supraclavicular methods for brachial plexus blocks in upper extremity surgeries will be compared.

Currently, brachial plexus block performed with various approaches is preferred to general anesthesia due to its advantages in upper extremity surgeries. These advantages can be listed as protecting the patient's consciousness, minimum effect on breathing, reducing airway interventions, enabling long-term postoperative pain control, reducing opioid-related side effects, limiting metabolic and endocrine changes due to surgery, and early discharge of hospital. The supraclavicular approach has a rapid onset of block and a high success rate. Close proximity to the pleura is the main disadvantage, but the widespread use of USG in peripheral blocks has also reduced the risk of complications related to this proximity. In the selective truncus approach defined by Manoj Kumar Karmakar in 2020, three trunks of the brachial plexus can be identified separately and selectively blocked under ultrasound guidance. It has been suggested that sensory/motor block occurs in all ipsilateral upper extremity dermatomes except T2 by selective blocking of the upper, middle, and lower trunks. In this study, the selective trunk method and the supraclavicular method will be compared.

Patients who will undergo upper extremity elbow and below-elbow surgery in the orthopedics and traumatology operating room will be included in the study. The primary aim of the study is to compare the success rates of supraclavicular and selective truncus blocks in patients scheduled for hand, wrist, forearm, and elbow surgery. Comparisons will be made by measuring the first analgesic time after surgery. Secondary aims are sensory and motor block success rates between the two methods. The block application time, preparation time for surgery, number of needle insertions, tourniquet pain, diaphragmatic paralysis rate, complications (vascular puncture, paresthesia, horner's syndrome, hoarseness, local anesthetic toxicity, pneumothorax) patient satisfaction, surgeon satisfaction and total analgesic amount at the end of the postoperative 12 and 24 hours will be recorded.

Eligibility Criteria:
Inclusion Criteria:

- Patients undergoing upper extremity elbow and below-elbow surgery in the orthopedics and traumatology operating room

Exclusion Criteria:

* Patient's refusal
* ASA IV,
* Pregnancy,
* Neuromuscular disease,
* Peripheral neuropathy
* Bleeding disorders,
* Local anesthetic allergy,
* Infection in the block area
* Operations without using a tourniquet
In Utero Surgery for Fetal Myelomeningocele: Decision-making Mechanisms and Psychological Impact of Prenatal Therapy

Myelomeningocele is a malformation of the spine and spinal cord, generally diagnosed prenatally, and responsible for a complex disability for the unborn child. In the event of continued pregnancy, in utero surgery can be performed to improve the prognosis of the children. This fetal therapy does not allow a cure and induces risks for the fetus, and for the mother, both during surgery and for her obstetric future.

Currently, few studies have focused on the factors influencing the choice to resort to in utero surgery and the experience of patients and co-parents before and after this intervention. No qualitative study on the subject has been published to date.

The study population corresponds to all couples who have chosen to continue the pregnancy in the face of a prenatal diagnosis of myelomeningocele in their fetus as well as to resort to in utero surgery to repair this malformation. In order to obtain the largest possible sample, the study will be offered to both couples who have had open surgery and those who have had fetoscopy.

This study aims to investigate, a posteriori, the experience of couples who have chosen fetal surgery to repair a myelomeningocele.

This is a study in clinical psychology, cross-sectional observational with an approach that will be mixed, qualitative and quantitative.

In practice, the only procedures added by the research will consist of:

* an interview between the mother of the child operated on in utero and a psychologist researcher-student pair in Master 2 of psychology
* an interview between the father of the child operated on in utero and a psychologist researcher-student pair in Master 2 of psychology
* the completion of a decision scale by each of the parents The presence of the interview with a psychologist not planned as part of the care may lead to the modification of the usual care of the parents.

Eligibility Criteria:
Inclusion Criteria:

* Mothers and adult co-parents of the child with MMC operated in utero, having signed informed consent. If both members of the couple have agreed to participate, they will be received separately.
* Mother who had fetal surgery for in utero repair of a fetal myelomeningocele by laparotomy and hysterotomy aged 18 years or older at the time of surgery, and whose child affected by the surgery is at least 6 months old
* Speaking French
* Not presenting a severe psychiatric disorder altering the relationship with reality
* Patient affiliated to a social security system

Exclusion Criteria:

* Patient under guardianship or curatorship, deprived of liberty or unable to sign informed consent to participate in the study
* Patient under State Medical Aid
Parental Adherence of a Mobile Application

This is a single-site, stratified grouping parallel- randomized control trial design comparing 30-day all-cause readmission rates and parent experience with two groups of pediatric participants.

This proposal's overall objective is to evaluate the effectiveness of an enterprise-level outpatient nursing care model with an asynchronous mobile health platform for parents of children with medical complexity (CMC) age 0-3 years to communicate with their child's healthcare team via remote patient monitoring (RPM).

The researchers will evaluate the efficacy of a proactive nursing care model on 30-day readmissions (Aim 1), parental experience and managing their child's care at home (Aim 2), and healthcare team engagement frequency with a proactive outpatient nursing care model necessary to achieve adoption into outpatient models of care (Aim 3).

Eligibility Criteria:
Inclusion Criteria:

* Age 0-3 years 11 months with a parent/Legally authorized representative
* Children with complex medical conditions with medical technologies (feeding, oxygen saturation monitor, and/or oxygen equipment) prescribed by the inpatient care team,
* Discharging to a home setting with parents/legally authorized representatives (LAR's) who can read primarily English, Spanish, Somali, Burmese, Korean, Chinese-Simplified, German, French, Filipino, Arabic, and Vietnamese.
* Availability to download a mobile application onto a parent/LAR-owned device

Additionally, adult participants will also be included and grouped as follows:

Adult Group 1: Parents/Legally authorized representatives of pediatric subject as part of a dyad.

Adult Group 2: Healthcare team users at Children's Mercy Kansas City.

Exclusion Criteria:

* Inability to be discharged to care in the home setting.
* Those not meeting the above inclusion criteria.
* We will exclude a child who is followed solely by the Cardiac High Acuity Monitoring Program Heart Center outpatient team as randomization for this patient population would impact the study design (NCT0603439)
* Those children with PICC lines as their only medical technology.

Equitable Selection: Parent/LAR that do not speak or read one of the 11 languages available in the CHAMP application will be excluded due to potential translation limits of the app.

Healthcare team users: Non-Employees of Children's Mercy.
Safety and Clinical and Microbiological Efficacy of the Combination of Fluconazole and Secnidazole for the Treatment of Symptomatic Vaginal Discharge

Genital tract infections (GTIs) have increased in the past decade and there is an association between sexually transmitted infections (STIs) and other infections like bacterial vaginosis (BV), with the HIV transmission. BV and Candida are the most common causes of vaginal infections in symptomatic women, the prevalence of BV being 22-50% and the prevalence of Candida 17-39%. In an effort to reduce the transmission of GTIs, the World Health Organization (WHO) proposed a syndromic diagnostic approach as a low cost alternative in places with no access to laboratory diagnostic tests.

Justification. In patients with syndrome of vaginal discharge, an effective treatment against Candida albicans, Trichomonas vaginalis, and bacterial vaginosis is adviced, therefore, for syndromic management of symptomatic vaginal discharge the combination of fluconazole and secnidazole could be used. No studies evaluating this combination were found in the literature reviewed.

Objectives: To describe the safety and the clinical and microbiological efficacy of a single oral dose of a combined treatment with secnidazole + fluconazole for the syndromic management of symptomatic vaginal discharge.

Methods: Design: open label, uncontrolled clinical trial to estimate clinical efficacy and safety of the combination of fluconazole and secnidazole for the treatment of symptomatic vaginal discharge. The participants will be sexually active women with lower genital tract symptoms (leukorrhea, itching, burning, pain, foul-smelling vaginal discharge, or urethral symptoms) compatible with symptomatic vaginal discharge syndrome. The study will be conducted in an outpatient service of a hospital in Bogota, Colombia. Given the descriptive character of the study, no a priori hypothesis is considered. A consecutive convenience sample size of 100 symptomatic patients is calculated. The statistical analysis will be performed with STATA 11.0 software (College Station, Texas, USA). Simple and relative frequencies and measures of central tendency and dispersion appropriate for the distribution of the variables will be calculated. The study has been submitted and approved by the Ethics Committee of the Faculty of Medicine of the National University of Colombia and the Institutional Review Board of the participating institution. All women must sign a written informed consent form agreeing to voluntarily participate in the study.


Eligibility Criteria:
Inclusion Criteria:

* sexually active women with lower genital tract symptoms compatible with BV or vaginitis

Exclusion Criteria:

* patients with a clinical diagnosis of cervicitis
* severe medical conditions
* liver disease
* allergies, or known reactions to the drugs under study were excluded from the study
* pregnant women
* women who were not yet sexually active
* women who had previously participated in the study
* women who had received antibiotic therapy in the previous 14 days
Observational Study of Anti-Cancer Therapy Induced Oral Mucositis in Korean Cancer Patients

to survey oral mucositis after chemotherapy and Concurrent chemoradiotherapy in Korean cancer patients


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with one cancer among head and neck cancer, esophageal cancer, breast cancer, colorectal cancer, gastric cancer, and non-small cell lung cancer, who are being treated or going to be treated as one between A and B A. Chemotherapy only B. Concurrent chemoradiotherapy

Exclusion Criteria:

* Patients who are pregnant or breast feeding, absent from effective(medically proven) contraceptive method for females of childbearing potential
* Patients with performance status of ECOG score is more than 3
Cerebral Metabolism in Patients With Refractory Chronic Cluster Headache Treated by Occipital Nerve Stimulation

The occipital nerve stimulation (ONS) is used to treat patients with refractory primary chronic headache but its mechanism of action (MoA) remains unknown. Different hypothesis have been suggested in particular a specific action on cerebral generators involved in different types of primary headaches or a non specific action on pain modulatory network.

The aim of this study, using the chronic cluster headache as a model, is to determine the changes in cerebral metabolism induced by ONS to precise its MoA in the treatment of primary chronic headache.


Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years
* chronic cluster headache (according to the IHS)
* refractory in who a treatment by ONS have been indicated
* patient affiliated at social security,
* informed consent signed

Exclusion Criteria:

* contraindication to MRI
* contraindication to 18F-FDG PET
* women without contraception/pregnant/breast-feeding
* patient non-compliant
* patient on legal guardianship
A Study of Avastin (Bevacizumab) in Combination With Xelox and Tarceva in Patients With Metastatic Colorectal Cancer.

This study will evaluate the efficacy and safety of a first-line regimen of Avastin and Xelox (Xeloda + Eloxatin) followed by Avastin and Tarceva, in patients with metastatic colorectal cancer. Patients will receive 6 x 21 day cycles of treatment with Avastin (7.5mg/kg iv on day 1), Xeloda (1000mg/m2 po twice daily on days 1 to 14) and Eloxatin (130mg/m2 iv on day 1). Patients free of disease progression will then continue with Avastin (7.5mg/kg iv once every 3 weeks) and Tarceva (150mg po daily). The anticipated time on study treatment is until disease progression, and the target sample size is \<100 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, \>=18 years of age;
* adenocarcinoma of colon or rectum, with metastatic disease;
* \>=1 measurable lesion.

Exclusion Criteria:

* previous treatment with Avastin or Tarceva;
* previous systemic treatment for advanced or metastatic disease;
* adjuvant treatment for non-metastatic disease in past 6 months.
Pelvic Floor Exercises in Patients With Sjögren's

When the literature is examined, the positive effects of pelvic floor exercises on sexual functions have been supported by studies. However, the effectiveness of pelvic floor exercises on pelvic floor problems in women with sjögren has not been examined in the literature. The aim of this study is in order to examine the effect of pelvic floor exercises on sexual function in women with primer Sjögren Syndrome (pSS), since these negativities affect both the quality of life and sexual functions in women with pSS.

This is a randomized controlled trial examining the effect of 8 weeks of home-based pelvic floor exercises on pain, sexual dysfunction and quality of life on women with sjogren's.

Demographic information form, HAQ, VAS, Pelvic Pain Impact Questionnaire (PPIQ), Pelvic Floor Distress Scale-20, Female Sexual Function Inventory (FSFI), Pelvic Floor Impact Questionnaire (PFIQ-7) will be applied to female patients with Sjögren's who meet the inclusion criteria.After the initial evaluation, patients will be randomized to intervention and control groups. The intervention group will be taught home exercises including fast and slow contraction and keeping the muscles around the pelvic floor in different positions (sitting, standing, lying) and will be asked to do them every day for 8 weeks according to the determined protocol. For eight weeks, the patients will be supported by the phone by the physiotherapist and at the same time, they will be checked whether they do the exercises. The control group will be given training on pelvic floor anatomy. At the end of eight weeks, patients will be given a final evaluation and the results will be analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Be woman
* Having a diagnosis of primary sjogren's
* No comorbidities other than Sjögren's syndrome
* Not having had pelvic floor surgery
* Being sexually active
* Voluntary and consent to participate in the study

Exclusion Criteria:

* Other rheumatological diseases
* Urogynecological diseases
* Sarcoidosis
* lymphoma
* Having had a non-cesarean gynecological operation
* Infection
Superficial Dry Needling Versus Deep Dry Needling on the Upper Trapezius

This study investigates the effect of two different techniques (deep dry needling and superficial dry needling) on the latent myofascial trigger point in the upper trapezius. Subjects with latent Myofascial trigger point in this location of the muscle will be identified and will be randomly assigned to one out of the three groups: deep dry needling, superficial dry needling or sham dry needling in gastrocnemius muscle. cervical range of motion and pain pressure threshold in the upper trapezius will be registered before, immediately after the intervention, at 24 hours after the intervention, at 72 hours after the intervention and a week after the intervention


Eligibility Criteria:
Inclusion Criteria:

* Present the latent Myofascial trigger Point (MTP) 1 in upper trapezius.
* Accept participation in the study (signature of informed consent).
* Be in an age range between 18 and 55 years.
* Do not present any exclusion criteria.

Exclusion Criteria:

* Do not present MTP 1 latent in the upper trapezius.
* Suffering and / or having suffered from upper limb pathologies, deformities or orthopedic injuries that could alter the static and biomechanics of the shoulder and neck.
* Not clearly identify the MTP 1 in the upper trapezius.
* Have been diagnosed with fibromyalgia, myelopathy or radiculopathy.
* Having contraindicated the technique of dry needling for suffering, for example, coagulation problems.
* Having suffered a whiplash.
* Be pregnant.
* Have used analgesics 24 hours before participating in the study.
* Having belonephobia.
* Know the study techniques.
* Be in physiotherapy treatment and / or have been treated with needle techniques at some time.
* Having had cervical surgery.
An Observational Study on Intermittent Self Catheterisation Discontinuation Factors in Multiple Sclerosis Patients

Urinary disorders (UD) are common in Multiple Sclerosis (MS) and can necessitate using Intermittent Self Catheterisation (ISC). It is well experienced by patients, has little impact on daily life and improves quality of life. However, studies are lacking on long-term adherence to this treatment as well as on discontinuation factors. Our main objective is to prospectively assessed factors associated with ISC discontinuation 2 years after having introduced this technique.

Urinary disorders (UD) are common in Multiple Sclerosis (MS). About 65% of patients suffering from moderate to severe troubles. In case of voiding dysfunction, the reference treatment is based on intermittent self catheterisation (ISC). UD in spinal cord injury (SCI) patients have been widely studied. They are very common, and are life-threatening in the absence of appropriate care. Management of neurological UD (as those occurring in MS) are well defined. ISC is the gold standard of bladder emptying method in this pathological context, and has been the subject of numerous studies. In SCI, the ISC discontinuation rate varies from 52 to 80% according to the published studies, the main factors of continuation being the autonomy to perform the technique, and the continence rate. However, the results are variable. In case of MS, the studies are lacking, the results concerning the discontinuation rate and factors associated with discontinuation are poor. Our main objective within the French speaking neurology study group (GENULF), is to prospectively assessed factors associated with ISC discontinuation 2 years after having introduced this technique.

This predictive study will be multicenter, observational, analytical, and prospective and will not modify current clinical practice.

We will record clinical and urinary data at each visit (inclusion, 6 weeks, 6 months, 12 months, and 24 months). We will note also if the patient practice ISC as prescribed in order to identify discontinuation of the ISC.

Eligibility Criteria:
Inclusion Criteria:

* Patient aged 18 to 65 years
* Patient with MS
* First ISC prescription
* Patient giving informed consent
* Patient affiliated to the social security system

Exclusion Criteria:

* Patient who has already tried / practiced ISC
* Patient under safeguard of justice / guardianship / tutorship
* Pregnant or lactating woman