cyrilzakka/clinical-trials huggingface dataset:
Piezowave for Treatment on Lateral and Medial Elbow Tendinopathies

Within the outpatient rehabilitation clinic, therapists provide therapeutic interventions to treat patients with various tendinopathies, including lateral and medial epicondylosis. Current conservative treatment includes immobilization for forced rest of the inflamed tendons and muscles, as well as mobilizations to focus stimulation of synovial fluid, provide movement to nourish cartilage, promote periarticular extensibility, and provide sensory and proprioceptive input. Musculoskeletal disorders can accompany both local and referred pain patterns that need to be assessed and treated. When an acute trauma or repetitive micro-trauma occurs, that may result in decreased range of motion and increased pain causing the onset of weakness and function of the affected extremity. An alternative approach is through the provision of Piezowave Myofascial Acoustic Compression Therapy (MyACT), which provides mechanical stimuli delivery to improve circulation and provide relief of pain. The focused sound waves produced by the Piezowave MyACT device are classified by a pressure surge, which is followed by a drop in pressure and a brief negative pressure phase low energy/low pressure application. It is this transformation of mechanical stimuli into biochemical signals, or mechanotransduction, which yields the treatment of myofascial and musculoskeletal pain. There is currently limited research to support the benefit in regards to increased function and decreased pain when the Piezowave MyACT is used for the treatment of lateral and medial epicondylosis. Of the limited research available, treatment with non-invasive shock wave therapy, complications are low and effect is achieved in most cases within three to five sessions.

If Piezowave Myofascial Acoustic Compression Therapy (MyACT)) is applied as treatment for symptoms of lateral and medical elbow tendinopathies, then the patient will experience increased function demonstrated by Quick DASH (Disability of the Arm, Shoulder and Hand) score and decreased pain demonstrated by subjective reporting on the numeric pain rating scale.


Eligibility Criteria:
Inclusion Criteria:

* Tendinopathy symptoms referred for occupational therapy by physician.
* Positive provocation tests

Exclusion Criteria:

* Contraindications for shock wave

  * Infections
  * Tumor tissue
  * Blood clotting disorder
  * Blood thinning medication use
  * Pregnancy
  * Lung tissue in focal area
  * Head
  * Air-containing organs
  * Elbow fracture
* History of corticosteroid injections less than eight weeks/two months, prior to initiation of occupation therapy treatment for lateral or medial epicondylosis. The goal would be to have elimination of any residual benefit from the injection.
Controlled Trial on Effect of Montelukast Treatment in Children With Obstructive Sleep Apnea Syndrome

Oral therapy with montelukast may lead to improved polysomnographic findings in children with mild to moderate OSAS with and without allergic rhinitis who a priori require T\&A for OSAS.

- A significant proportion of the children with OSAS treated with montelukast will show reduced severity of OSAS, and this will obviate the need for surgical T\&A.

Primary Specific Aim. To conduct a randomized double blind 16-week trial comparing the effect on polysomnographic measures of the administration of once a day oral montelukast therapy vs. placebo in children with OSAS.

Secondary Specific Aim. For all children with the original AHI at diagnosis of \>2 hrTST, we expect improvements in the severity of sleep apnea to occur following treatment with montelukast. Therefore, we will examine the overall reduction in AHI and also how many of these children have AHI\< 2 after the 16-week treatment. In other words, the percentage of children converting from needing T\&A surgery before treatment with montelukast to not needing surgery after treatment will be examined.

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic snoring children \> 2 years of age and \< 10 years of age, who snore and have an apnea hypopnea index (AHI) \>2/hrTST (hour total sleep time), and in whom T\&A is therefore contemplated. Also among these, we will include children referred for evaluation for snoring who have a history of allergic rhinitis.

Exclusion Criteria:

* Hypersensitivity to montelukast
* Immunodeficiency or immunosuppressant therapy
* Craniofacial, neuromuscular, syndromic or defined genetic abnormalities
* Acute upper respiratory tract infection
* Systemic corticosteroid therapy or antibiotic therapy in the 2 weeks previous to the study
* Children who already had adenotonsillectomy.

In addition, children chronically receiving oral antihistamine preparations or nasal decongestants will be required to continue using these medications throughout the duration of the study. Patients receiving immunotherapy will continue on the same regimen without escalation of dose and frequency throughout the duration of the study. In addition, patients with severe OSA who in the opinion of their treating physicians require early surgical intervention for their OSA will be excluded from eligibility to the study.
The Effect of Remote Ischemic Conditioning in Patients With Hypercholesterolemia

There is an on-going discussion weather remote ischemic conditioning (RIC) is effective in limiting the damage of reperfusion injury in STEMI patients. The results from recent RCTs have been variable and most have not shown convincing positive results when analyzing hard endpoints. Hence, there is a great need to evaluate the impact of comorbidities on the effectiveness of RIC. Therefore, we have designed a study to evaluate the impact of hypercholesterolemia on the RIC response by evaluating ischemia-induced endothelial dysfunction.

Aim: To investigate the impact of hypercholesterolemia on the RIC response in counteracting ischemia-induced endothelial dysfunction.

Study population:

We plan to include 12 poorly controlled/newly diagnosed subjects with familiar hypercholesterolemia (FH) and 12 age-matched control subjects.

Inclusion criteria (FH subjects)

* Poorly treated FH, defined as LDL-C \>5.5 mmol/L.
* Age, \>18 and \<65 years of age.

Exclusion criteria

* Additional cardiovascular comorbidities such as diabetes mellitus, coronary artery disease, or kidney failure.
* Unwillingness to participate.
* Concurrently participating in another interventional trial.

Main exposure:

Remote ischemic conditioning, i.e. 4 cycles of 5 minutes of ischemia to the lower limb.

Comparision group:

Cross over design, patients preform the protocol twice, once with sham and once with RIC. Also a group of healthy matched controls will be recruited.

Outcome:

Change in FMD after 20 minutes of ischemia and 20 minutes of reperfusion with the exposure of either sham or RIC.

Design:

Randomized interventional cross-over.

Eligibility Criteria:
Inclusion Criteria:

* Poorly treated FH, defined as LDL-C \>5.5 mmol/L.
* Age, \>18 and \<65 years of age.
* A age matched control-group.

Exclusion Criteria:

* Additional cardiovascular comorbidities such as diabetes mellitus, coronary artery disease, or kidney failure.
* Any condition which interfere with the outcome recording for example atrial fibrillation.
* Unwillingness to participate.
* Concurrently participating in another interventional trial.
A Phase 1 Study to Evaluate the Safety of MEDI7814 in Adult Volunteers

This is a Phase 1 study to evaluate the safety and tolerability of single ascending intravenous doses of MEDI7814 in healthy adult subjects.

This is a Phase 1, randomized, double-blind, placebo-controlled study to evaluate the safety and tolerability of single ascending intravenous doses of MEDI7814 in healthy adult male subjects and female subjects of non-childbearing potential.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years up to and including 49 years at the time of first dose of investigational product
* Healthy by medical history, physical examination, and laboratory studies
* Body weight 50-125 kilogram (kg); body mass index 19.0-32.0 kilogram per square meter (kg/m\^2) (inclusive)
* Females must be of non-childbearing potential.

Exclusion criteria:

* Any acute illness within 30 days of screening
* Concurrent enrollment in another clinical trial
* The subject has a positive drug/alcohol screen at screening or Day -1
* Pregnancy
* Current cigarette smokers
* History of cancer other than non-melanoma skin cancer or in situ carcinoma of the cervix treated with apparent success
* Use of immunosuppressive medications
* Subjects who have an unresolved infection with any Neisseria species
* Subjects who have had their spleen removed for any reason.
CT-guided Needle Guidance Using Stereotaxic Unit, Navigation Versus Conventional Biopsy Technique for the Percutaneous Pulmonary Nodule Biopsy

The purpose of this study was to compare the safety and efficacy of CT-guided needle guidance using stereotaxic unit, navigation versus conventional biopsy technique for the patients scheduled to undergo percutaneous pulmonary nodule biopsy.


Eligibility Criteria:
Inclusion Criteria:

* Patient with localized lesions such as pulmonary nodules on chest x-ray, CT or PET CT
* Histopathologic examination is necessary if lung lesion is unknown
* Histologic findings affect the disease stage or treatment plan
* If the investigator decides to perform a percutaneous lung biopsy because the biopsy or diagnosis through the bronchoscopy is not possible or has low risk-benefit
* Patient who have consented to contraception during the period of clinical trial participation (one month after the procedure)
* Patient who voluntarily agree to participate in this clinical trial and are willing to comply with the protocol

Exclusion Criteria:

* Patient with pulmonary function insufficiency
* Patient who has difficulty in self-breathing (e.g, breathing through oxygen breathing apparatus)
* Patient with Uncontrolled coagulation disorders (INR \> 1.3 or Blood platelet count \< 50,000/µl)
* Patient with allergy to CT contrast agent
* Patient under 19 years old or over 80 years old
* Pregnant or lactating
* Patient with uncontrollable systemic disease (e.g, uncontrolled hypertension, uncontrolled cardiovascular disease, etc.)
* Patient who currently participating or has participated in other clinical trials within 30 days of the screening date
* If it is judged inappropriate to participate in this clinical trial under the judgment of the investigator
Observational Cohort of COVID-19 Patients in Hubei Province

This study intends to use the relevant case data of COVID-19 in Hubei Province, using big data processing and mining methods to evaluate the effects of clinical indicators, drug use and genes on the clinical prognosis of COVID-19 patients, so as to provide a theoretical basis for the treatment of these diseases and reduce the mortality.

Hubei Province, as the forefront of the fight against epidemic, has the largest number of patients infected with SARS-CoV-2 and the highest quality medical data. However, so far, these data have not been fully analyzed, if these data can not be mined and used, it will be a great loss to the whole human race. By fully mining and analyzing these data, we can sum up a large number of experiences related to COVID-19, summarize various laws of this kind of disease, and provide clinical evidence based on large samples for the research of this disease, eventually contribute China's experience to the global fight against the epidemic.

Based on the above background, this study intends to use the relevant case data of COVID-19 in Hubei Province, using big data processing and mining methods to evaluate the effects of clinical indicators, drug use and genes on the clinical prognosis of COVID-19 patients, so as to provide a theoretical basis for the treatment of these diseases and reduce the mortality.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18, regardless of gender;
2. A history of epidemiology, including travel or residence in high-risk areas or other communities with case reports within 14 days before the onset of the disease, or have a history of contact with novel coronavirus infection (those who are positive for nucleic acid tests); or patients with fever or respiratory symptoms from the community with case reports; or aggregative onset;
3. Corresponding clinical manifestations, including respiratory symptoms such as fever, with typical imaging features of COVID-19, normal or decreased white blood cell count and decreased lymphocyte count in the early stage of the disease;
4. Clear etiological evidence, including real-time fluorescent RT-PCR detection of novel coronavirus nucleic acid positive, or viral gene sequencing, is highly homologous to novel coronavirus.

Exclusion Criteria:

Patients who meet any of the following criteria cannot be enrolled in this study:

1. Patients refused to participate in this study;
2. According to the researchers, patients are unable to complete this study or comply with the requirements of this study (due to management or other reasons).
Neurocognitive Correlates of Behavioral Treatment for Childhood Tic Disorders

The study aims to clarify the functional anatomy of key brain circuits associated with cognitive control in children and adolescents with chronic tic disorders (CTD) and to compare and contrast hypothesized mechanisms related to increased tic control associated with Habit Reversal Training, a behavioral treatment that been previously shown to be effective in treating CTD. We also seek to better understand the relationship between fMRI and quantitative EEG in relevant brain circuits with the hope of establishing EEG as a valid and cost-effective marker of treatment responsiveness. A total of 25 subjects will be randomized to 10 weeks of Habit Reversal Training (HRT), a behavioral treatment, and 25 to 10 weeks of minimal-contact waitlist. Treatment responders will be re-assessed at three months. Waitlist nonresponders will be provided with 10 weeks of HRT. Study assessments, including a neurocognitive battery and quantitative EEG will be administered at baseline, Wk 5, Wk 10, and 3-month follow-up. Neuroimaging (fMRI) will be conducted at baseline and Wk 10.


Eligibility Criteria:
Inclusion Criteria:

* DSM-IV diagnostic criteria for CTD (CMVT or TS)
* Clinical Global Impressions - Severity Score \> 3 (moderately ill or worse)
* YGTSS Total Score \> 14 (or Total Score \> 10 if CTD with motor tics only)
* Unmedicated or on stable psychotropic medication for at least 6 weeks prior to study entry, with no planned changes for duration of study participation
* Child is fluent English speaker
* Parental Informed Consent and Child Informed Assent.

Exclusion Criteria:

* Total YGTSS Score\>35 (Cases above this threshold otherwise eligible will be reviewed by Clinical Caseness Panel for potential study participation)
* IQ \< 80 on the Wechsler Abbreviated Scale of Intelligence (WASI)
* Problematic Substance Use or DSM-IV Conduct Disorder in past 3 months
* Lifetime DSM-IV diagnosis of PDD, Mania, or Psychotic Disorder
* Any serious psychiatric, psychosocial, or neurological condition requiring immediate treatment other than that provided in the current study
* Previous treatment with four or more sessions of HRT for tics
* Contraindication to fMRI scan
Pepsin in Patients With Functional Dyspepsia

This non-interventional, observational study investigates the course of symptoms in patients with functional dyspepsia under treatment with a fixed combination of pepsin and amino acid hydrochloride over a period of approximately 6 weeks. The change of the Gastrointestinal Symptom Score (GIS©) was the primary parameter for the assessment of efficacy and was performed at baseline, after 3 and 6 weeks of treatment respectively. Safety measures included recording of AEs and physical examination as well as measurement of vital signs. The aim was to observe 100 patients during the course of this non-interventional study.


Eligibility Criteria:
Inclusion Criteria:

* Patients with dyspepsia
* Women and men aged between 18 and 75

Exclusion Criteria:

- Unwilling to consent
PK/PD and Clinial Outcomes of Beta-lactams in ICU Patients

Meropenem and imipenem are broad-spectrum carbapenem antibiotic and are frequently prescribed in critically ill patients with severe infections. These patients show several pathophysiological changes that may alter the carbapenem pharmacokinetic (PK) normally found in other populations. Although the PK of carbapenems has been widely studied, most studies have been conducted on small populations, and clinical outcome data are sparse. Therefore, the aims of this study are (i) describe the population pharmacokinetic parameters of meropenem and imipenem in critically ill subject (ii) evaluate the pharmacodynamic of meropenem and imipenem as a predictor of clinical treatment outcome.


Eligibility Criteria:
Inclusion Criteria:

* age \>18 years
* severely ill patient who admitted to medical or surgical intensive care unit who require a treatment with meropenem or imipenem antibiotic

Exclusion Criteria:

* severe renal impairment and require renal replacement therapy
* APACHE II score \>30
* History of hypersensitivity to carbapenems
* Pregnancy or breast-feeding female
Nutributter Programming to Prevent Undernutrition: an Evaluation

This randomized, controlled effectiveness study examines Nutributter programming within an integrated package of maternal and child health services offered by Haiti's Ministry of Health (MSPP) to prevent undernutrition among young children in Haiti. The aim of the process evaluation is to better understand the uptake of Nutributter® as a complementary food in the diets of young children and its feasibility and acceptability as part of MSPP's package of services. This project is being carried out at a public hospital in Fort San Michel, an impoverished community outside of Cap Haitien, Haiti.


Eligibility Criteria:
Inclusion Criteria:

* Infants 6 to 12 months old
* Lives in Fort San Michel

Exclusion Criteria:

* Moderately or severely malnourished
* Peanut allergy
A Pilot Intervention With Families of Children With Special Health Care Needs

This is a pilot randomized controlled trial of a behavioral intervention focused on improving parenting skills and preventing child neglect in families of children with special health care needs. The intervention focuses on problem solving, distress tolerance, and emotional regulation skills.

This pilot randomized controlled trial will be conducted with 60 caregivers of children with special health care needs who have been reported to the child protection team at Boston Medical Center with concern for neglect that was ultimately not substantiated. Half of the subjects will be randomly assigned to receive the 6-session, one-on-one, in-person, behavioral intervention focused on problem solving, emotional regulation, and distress tolerance. The other half will be randomly assigned to the control group and will receive periodic check-ins and referrals to community resources as needed. Both groups will be followed for 12 months after randomization.

Children who have previously experienced neglect, or other forms of maltreatment, will not included in the study. Children will be defined as having special health care needs if they have a chronic physical, emotional, or behavioral condition.

With this pilot, the investigators aim to field-test study mechanics, including enrollment, randomization, and the collection of baseline and follow-up data; and obtain empiric estimates of study parameters to inform a subsequent fully-powered randomized controlled trial.

Eligibility Criteria:
Inclusion Criteria:

* Primary caregiver of a child under age 7 with a special health care need, defined as a chronic physical, emotional, or behavioral health condition
* Child has been referred to the Child Protection Team for neglect that was ultimately not substantiated
* Fluent in English or Spanish

Exclusion Criteria:

* Prior history of substantiated child maltreatment
Skin Diseases and Pregnancy: Which Heathcare Professionals ?

Pregnancy-induced physiological dermatological changes are common. In 2016, they represented between 23% (acne) and 75% (pigmentary changes) of pregnancies in France. Some dermatological changes require medical advice to identify a possible pathological rash.

These pathological rashes can be dangerous for the mother or the fetus.

The aim of this study is to assess the prevalence of skin diseases during pregnancy and to evaluate the care pathway in a healthcare sector (Vendee) for these pregnant women?

Pregnancy-induced physiological dermatological changes are common. In 2016, they represented between 23% (acne) and 75% (pigmentary changes) of pregnancies in France. Some dermatological changes require medical advice to identify a possible pathological rash.

These pathological rashes can be dangerous for the mother or the fetus. It is therefore essential to recognize them for a quick specialized treatment. They include: intrahepatic cholestasis of pregnancy, pemphigoid gestationis, polymorphic eruption during pregnancy, atopic eczema, generalized pustular psoriasis in pregnancy.

In view of the demography of dermatologists in the Vendee, 18 dermatologists in 2020 in all establishments (hospitals, clinics, practices), the general practitioner is at the center of these considerations.

The aim of this study is to assess the situation of skin disease during pregnancy and to evaluate the care pathway in a healthcare sector (Vendee) for these pregnant women?

Eligibility Criteria:
Inclusion Criteria:

* Any woman who gives birth at Departmental Hospital Center of Vendee

Exclusion Criteria:

* Patient's refusal to participate in the study
Retrospective Analysis of the Effects of Perioperative Osteoanabolic Treatment on Patients With Spinal (Fusion) Surgery.

This study is to review the the effect of PTH on the outcome of spinal fusion surgery by analyzing the procedure with Forsteo (PTH) previously used in the University Hospital Basel and the Endonet Clinic, as part of a retrospective, observational study.

Spinal fusion operations have been performed in patients with risk factors related to healing or bony consolidation. A distinction is made between risk factors that can be influenced, such as nicotine consumption or the intake of glucocorticoids, and non-modifiable risk factors, such as diabetes mellitus or chronic obstructive pulmonary disease (COPD), which impair bone formation. The presence of these risk factors leads to an increased rate of unhealed fusions, which is why ways are being sought to reduce them. One possibility, in addition to correcting the modifiable risk factors, is the use of topical or systemic drugs.

As early as 2009 and 2010, the effect of parathyroid hormone (PTH) on spinal fusions was investigated in animal experiments. In the studies, a significantly better result was found by therapy with PTH.

In 2012, the effect of PTH on the outcome of spinal fusion surgery in post-menopausal women with osteoporosis in his prospective study was investigated, and another study evaluated the optimal duration of PTH therapy. Overall, the studies to date indicate the benefit of pharmaceutical supplemental therapy. For this reason, it was used on a case-by-case basis in patients undergoing spinal surgery at the University Hospital Basel.

This study is to review the results cited above by analyzing the procedure with Forsteo (PTH) previously used in the University Hospital Basel and the Endonet Clinic, as part of a retrospective, observational study.

Eligibility Criteria:
Inclusion Criteria:

* Patients with spinal (fusion) surgery at the Clinic for Spinal Surgery/ University Hospital Basel
* Perioperative osteo-anabolic therapy between January 1st, 2013 and December 31st, 2018.

Exclusion Criteria:

* Contraindications to PTH therapy
* Patients refusing therapy with PTH