cyrilzakka/clinical-trials huggingface dataset:
A Study to Investigate Efficacy and Safety of TOUR006 in Participants 18 to 80 Years of Age With Thyroid Eye Disease

Phase 2b trial of TOUR006 in Thyroid Eye Disease (TED) to evaluate 20mg and 50mg doses against placebo given by a subcutaneous injection every eight weeks to TED patients who are in the active inflammatory phase of disease.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Graves' disease associated with moderate to severe active TED
* Onset of active TED symptoms within approximately 15 months
* Proptosis (exophthalmos) ≥3 mm above the normal range per investigator judgment (based upon race and gender) for the study eye
* CAS ≥4 (on the 7-item scale) for the study eye
* Presence of TSI \>130% of the normal reference standard or \>0.55 IU/L (depending on assay method) and laboratory reference ranges

Additional inclusion criteria are defined in the study protocol.

Exclusion Criteria:

* Anticipated need for intervention due to sight-threatening complications or other significant and acute deterioration in vision
* Any previous treatment with teprotumumab or other agent that inhibits the IGF-1 receptor
* History of systemic (eg, oral or IV) steroid use with a cumulative dose equivalent to \>1 g of methylprednisolone for the treatment of TED. Previous oral steroid use with a cumulative dose of ≤1 g methylprednisolone (or equivalent dosage for other systemic corticosteroid) for the treatment of TED, however, is allowed if the corticosteroid was discontinued at least 6 weeks before baseline (Day 1) and completely tapered by Baseline (if applicable).
* Systemic (oral or IV) corticosteroid use for conditions other than TED within 6 weeks of baseline (Day 1) or not completely tapered by baseline (if applicable).
* Any major illness/condition or evidence of an unstable clinical condition that, in the investigator's judgment, will substantially increase the risk to the participant, or confound the interpretation of safety assessments, if they were to participate in the study
* Any other condition that, in the opinion of the investigator, would impair the ability of the participant to comply with the study procedures or impair the ability to interpret data from the participant's participation in the study
* Pregnant or lactating

Additional exclusion criteria are defined in the study protocol.
Filgrastim for Premature Ovarian Insufficiency

Filgrastim is a Granulocyte-Colony Stimulating factor (G-CSF). It is an FDA approved drug. Very small embryonic-like stem cells (VSELs) are found in the ovary. Animal studies showed that these cells are able to regenerate the affected ovary. Studies on mice have shown that Filgrastim result in recovery of oogenesis after chemotherapy-induced gonadal failure (in 2013, 2014, and 2015).

Premature ovarian insufficiency (POI) has no curative treatment until now. Filgrastim is an FDA approved Granulocyte-Colony Stimulating factor (G-CSF). Very small embryonic-like stem cells (VSELs) are found in the testis and ovary. VSELs are stem cells that have noticed to survive chemotherapy induced gonadal failure. Data from animal studies showed that stimulation of these stem cells result in generation of the affected gonads. Studies on mice have shown a promising stimulating effect of Filgrastim on recovery of spermatogenesis and oogenesis after chemotherapy-induced gonadal failure (in 2013, 2014, and 2015).

Eligibility Criteria:
Inclusion Criteria:

* Women with Premature Ovarian Insufficiency (POI): For the purpose of the research women is considered to have POI if she is aged less than 40 years and has amenorrhea of at least 4 month with FSH level above 25 IU/L (repeated twice \>4 weeks apart).

Exclusion Criteria:

* Abnormal karyotype
* Previous pelvic or abdominal radiotherapy
* Previous surgical removal of the ovarian pathology
* Chronic disease: renal, liver, cardiac, malignancy
Cerebral Autoregulation in Patients With Epilepsy

The purpose of this study is to determine whether patients with epilepsy exhibiting impaired dCA, which may contribute to subsequent stroke.

The relationship between epileptic seizures and cerebrovascular disease is complex, ranging from mechanisms to clinical manifestation. Stroke is one of the most common causes of epilepsy in adulthood. It was also reported that patients with epilepsy exhibited a higher risk of stroke. But its potential mechanism was never fully understood. Dynamic cerebral autoregulation(dCA), a mechanism to maintain the cerebral bold flow, has been proved to be critical for the occurrence ,development and prognosis of ischemic neurovascular disease. In this study, we hypothesis that impaired dCA play a role in epilepsy and subsequent stroke.

Eligibility Criteria:
Inclusion Criteria:

* patients with epilepsy, as diagnosed by EEG

Exclusion Criteria:

* patients with status epilepticus
* intracranial and/or extracranial major vascular stenosis/occlusion diagnosed by a transcranial Doppler (EMS-9PB, Delica, China) and carotid ultrasound (IU22, Phillips, Andover, MA)
* a prior symptomatic cerebral vascular disease
* a history of hypertension, cardiovascular disease, diabetes, hyperlipemia, current arrhythmia, hyperthyroidism, anemia and unstable blood pressure, which may undermine hemodynamic stability, or inability to cooperate sufficiently to complete the cerebral auto regulation examination
* insufficient bilateral temporal bone windows for insonation of the middle cerebral artery
* intolerance to cerebral autoregulation measurements
Buzzy Distraction During Venipuncture

Venipuncture is one of the most common iatrogenic painful and stressful procedures performed on children. Interventions aimed at reducing the distress related to this experience are widely and strongly recommended. Pain and anxiety management is even more essential because it may modify children's memory for procedural pain and the subsequent acceptance of later health care painful interventions. Distraction is the most studied psychological technique to relieve venipuncture related pain and distress, with a strong evidence supporting its efficacy in children and adolescents.

In recent years several studies showed the effectiveness of a specific tool named Buzzy® (MMJ Labs, Atlanta GA, USA), in relieving pain and distress in children. Buzzy combines distraction and physical analgesia (vibration and cold) and it was positively tested during venipuncture, intravenous cannulation and painful injections in children. Even though its efficacy it's well established, most of the published trials did not compare Buzzy with other interventions, so that little data are available about its usefulness compared with other distractions techniques.

Hand-held computers are reusable tools, which offer a technological-based active distraction. There is evidence supporting their used during painful procedures such as venipuncture and a recent published study showed that hand-held computer distraction was as effective as nurse-led passive distraction techniques in children.

The aim of this study is to compare the effectiveness of Buzzy versus hand-held computer in pain relief during venipuncture.


Eligibility Criteria:
Inclusion Criteria:

* children from 4 to 12 years of age needing venipuncture

Exclusion Criteria:

* the presence of damage, denuded or broken skin in the site of Buzzy application;
* use of topical, enteral or parenteral analgesics within eight hours before enrolment;
* the presence of cognitive impairment or the inability to report pain verbally;
* the presence of chronic disease, included epilepsy, or of diseases associated with cold hypersensitivity (i.e., sickle cell anaemia, Raynaud's disease).
Bipolar Surgical Release in Congenital Muscular Torticollis

The congenital muscular torticollis is common disease in children.The indication for surgery is the children have persist deformity after 1 year old.Many surgical treatment had proposed such as unipolar release and bipolar release.By author experience the bipolar release had better results from complete cut the muscle both origin and insertion.This study wants to study the results of treatment in term of recurrence of the deformity.

the study perform in children with congenital muscular torticollis

Eligibility Criteria:
Inclusion Criteria:

* 1. all children age ranged from 5-15 years old who received the surgical treatment by bipolar release in the hospital.

Exclusion Criteria:

* 1. no history of surgery at the neck 2. no history of congenital anomalies and syndrome that effect the neck
Non-invasive and Invasive Assessment of Coronary Artery Disease

The purpose of the study is to assess the diagnostic accuracy of a combined use of non-invasive coronary angiography with multi-slice computed tomography (MSCT) and stress cardiac magnetic resonance (CMR) imaging in patients with obstructive lesions on MSCT and with low to intermediate pre-test likelihood of coronary artery disease (CAD) as compared to invasive coronary angiography (CAG) and Fractional Flow Reserve (FFR) measurements.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with stable angina pectoris with low to intermediate pre-test likelihood of CAD;
2. no previous history of CAD;
3. obstructive stenosis (≥50% luminal narrowing) on MSCT coronary angiography; 4.informed consent.

Exclusion Criteria:

1. patients with a previous history of CAD;
2. patients with contraindications for MSCT: a.cardiac rhythms other than sinus rhythm, b.pregnancy, c.allergy for contrast medium, d.renal failure (estimated glomerular filtration rate (eGFR) \< 50ml/min), e.resting heart rate \>75 bpm plus contra-indications for beta-blockade, f. weight \>100 kilograms;
3. contraindications for cardiac magnetic resonance (CMR) imaging: a.MR-incompatible implants, b. Claustrophobia, c. contraindications for adenosine: i. known or suspected hypersensitivity to adenosine, ii. known or suspected bronchoconstrictive or bronchospastic disease, iii. 2nd or 3rd degree atrioventricular (AV) block, iv. Sinus bradycardia (heart rate \< 45 bpm), v. Systemic arterial hypotension (\<90 mmHg). d. contraindications for gadolinium: i. renal failure (estimated eGFR \<30 ml/min);
4. no informed consent.
A Small Clinical Study: Photodynamic Therapy to Treat Hidradenitis Suppurativa

This study will investigate the efficacy of Photodynamic Therapy (PDT), which is the therapeutic use of photochemical reactions, in treating hidradenitis suppurativa (HS), a chronic inflammatory condition affecting areas of skin with sweat glands. We expect that PDT is effective in treating HS.

This study will investigate the efficacy of PDT using aminolevulinic acid (ALA) and either blue light or intense pulsed light on active lesions of HS. We will attempt to validate the success noted in a previously published case series using PDT with ALA and blue light (Gold, Bridges et al). We will evaluate effect of treatment by number of lesions, global disease severity, and patient self-assessment with the Dermatology Life Quality Index (DLQI).

Detailed informed consent will be obtained prior to treatment at study enrollment. The first four treatment visits will involve clinical evaluation, photography and application of the ALA to the affected area. After a 45 minute incubation period, the area will be washed and then treated with either blue light or intense pulsed light (IPL), depending on body area/investigator choice. One and three-month follow-up visits will involve evaluation of efficacy, but no active treatment.

Gold M, Bridges TM, et al. ALA-PDT and blue light therapy for hidradenitis suppurative. J Drugs Dermatol. 2004; 3 (1 Suppl):S32-5.

Eligibility Criteria:
Inclusion Criteria:

* multiple lesions consistent with HS in axillae/groin
* history of no or poor response to at least one treatment modality
* no active treatment in the 2 weeks prior to study initiation

Exclusion Criteria:

* Pregnancy/lactation
* photosensitizing drug use within 30 days of start of study
* active infection needing antibiotics
* history of porphyria or photosensitivity
Maine Lung Cancer Coalition: Using CHWs for the Annual Lung Cancer Screening Reminder

This research study will test whether support from a Community Health Worker (CHW) to address barriers to annual LDCT screening will result in an increased number of patients who receive the annual screening as per the recommended standard of care compared to passive outreach using a reminder letter.

This research study is a randomized controlled trial comparing phone outreach by a trained Community Health Worker (CHW) following a reminder letter to the reminder letter alone for patients who are at least a month overdue to have a routine annual low dose CT scan (LDCT) screening for lung cancer. CHWs will be able to identify and address barriers to accessing screening for those patients randomized to that arm of the study. Outcomes that will be measured include scheduling and completing the LDCT as well as agreeing to a referral for tobacco treatment.

Eligibility Criteria:
Inclusion Criteria:

* 30 or more pack years of tobacco use
* If no longer using tobacco, no more than 15 years since last use
* At least 13 months since last low dose CT scan screening

Exclusion Criteria:

* Development of serious medical condition that would preclude treatment of lung cancer if found
* Death since baseline screen
Vanderbilt University Spasticity Management Program Evaluation Plan

People with severe developmental disabilities frequently have comorbidities that make providing care to them more difficult. Spasticity is one such comorbidity. It produces increased muscle tone that can cause stiffness in joints and bodily contortions that can interfere with all of the major types of care provided to participants. Typically, care areas include splinting, hygiene, dressing, transfers, positioning, ambulation, and engaging in other functional activities. Moreover, persons with spasticity often experience pain.

Typically, spasticity is managed by health care providers using a combination of the following therapies:

* Physical / occupational therapy (PT / OT)
* Oral medication
* Botox injections
* Intrathecal baclofen administered by the Medtronic SyncroMed pump (ITB)
* Orthopedic / neurological surgery

As individuals are identified as appropriate participants for the Program and consent is obtained, the care team for each person, consisting of both medical and caregiver staff, will define up to three specific care area goals and related tasks for treatment. A comprehensive spasticity management program will then be developed for the individual. Clinical and outcome assessments at baseline and at follow-up will include measures of range of motion, global spasticity according to a modified Ashworth scale, and the time and number of staff required for the task. In addition, video will be obtained of caregivers performing each participant's care area tasks at baseline and follow-up to allow an independent external reviewer to judge task difficulty. Treatment will be provided as outlined by the spasticity management plan. Follow-up evaluations will be conducted when the participant is at least one year from their initial Botulinum injection, or are one year post-implant for ITB participants. When the participant is exited from the study, Survey Physician will be asked to rate the overall impact of the Program on each of the individual's care area tasks.

Eligibility Criteria:
Inclusion Criteria:

* Adult with spasticity residing at Clover Bottom Developmental Center in Nashville, Tennessee.
* Spasticity must interfere with daily functioning.
* Care team must be able to identify at least one treatment goal for the potential participant.

Exclusion Criteria:

* Family or guardian is unwilling to provide written informed consent.
* Spasticity does not interfere with patient's day-to-day care.
* Staff who provide daily care are unable to identify a clear treatment goal.
Safety Study of Natalizumab to Treat Multiple Sclerosis (MS)

The primary objective of this study is to compare the pharmacokinetic (PK) and pharmacodynamics (PD) of single subcutaneous (SC) and intramuscular (IM) doses of 300 mg natalizumab to intravenous (IV) administration of 300 mg natalizumab in multiple sclerosis (MS) participants. The secondary objectives are to investigate the safety, tolerability and PK of repeated natalizumab doses administered SC and IM, to investigate the immunogenicity of repeated natalizumab doses administered SC and IM, to explore proof of concept within the secondary progressive multiple sclerosis (SPMS) population using change from baseline in clinical measures including: expanded disability status scale (EDSS), multiple sclerosis functional composite scale (MSFC), symbol digit modalities test (SDMT), visual analogue scale (VAS), and visual function test; and brain magnetic resonance imaging (MRI) measures including: number of new or newly-enlarging T2 hyperintense lesions, number of new T1 hypointense lesions, number of new gadolinium-enhancing (Gd+) lesions, whole brain atrophy, magnetization transfer ratio (MTR), and diffusion tensor imaging (DTI) and to observe the effect of natalizumab administered IV and SC on brain MRI measures in participants with relapsing forms of MS.


Eligibility Criteria:
Key Inclusion Criteria:

* For arms 1,2,3 and 4: Diagnosis of Secondary Progressive Multiple Sclerosis (SPMS)
* For arms 5 and 6: Diagnosis of relapsing forms of Multiple Sclerosis (MS).
* No past history of receiving natalizumab.

Key Exclusion Criteria:

* For arms 1,2,3 and 4 Diagnosis of primary progressive MS or relapsing-remitting MS.
* Form arms 5 and 6: Diagnosis of primary progressive MS or secondary progressive MS without the occurrence of relapses.

NOTE: Other protocol defined inclusion/exclusion criteria may apply.
A Multiple Ascending Dose Study to Investigate Safety of KBP-7072 in Healthy Subjects

This is a double-blind, placebo-controlled, multiple oral dose study to evaluate safety, tolerability, and pharmacokinetic of KBP-7072 in healthy subjects.

This was a double-blind, randomized, placebo-controlled, parallel-group, multiple oral dose study. Overall, a total of 24 subjects were studied in 3 groups (Groups 1 to 3); with each group consisting of 8 subjects (6 subjects receiving KBP-7072 and 2 subjects receiving placebo). Groups 1 and 2 evaluated 100 and 200 mg QD, respectively. The dose level of 150 mg QD evaluated in Group 3 was determined based on data obtained from Group 2 of this stud

Eligibility Criteria:
Inclusion Criteria:

1. Females of nonchildbearing potential or males, of any race, between 18 and 50 years of age, inclusive, at screening.
2. Body mass index between 18.0 and 30.0 kg/m2, inclusive, at screening.
3. In good health, determined by no clinically significant findings from medical history, physical and ophthalmologic examinations, 12 lead ECG, vital sign measurements, and clinical laboratory evaluations (congenital nonhemolytic hyperbilirubinemia \[eg, suspicion of Gilbert's syndrome based on total and direct bilirubin\] is not acceptable) at screening and check in as assessed by the investigator (or designee).
4. Females of nonchildbearing potential defined as permanently sterile or postmenopausal. Males will agree to use contraception.
5. Able to comprehend and willing to sign an ICF and to abide by the study restrictions.

Exclusion Criteria:

1. Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator (or designee).
2. History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator (or designee).
3. History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair will be allowed). Cholecystectomy will not be allowed.
4. Alanine aminotransferase or AST ≥ 1 × ULN. Assessments may be repeated once if outside the range at screening and/or check-in, at the discretion of the investigator.
5. Fibroscan controlled attenuation parameter (CAP) \> 238 dB/m and vibration controlled transient elastography (VCTE) \> 7 kPa.
Can the Thoracic Replace the Conventional Radiography for the Diagnosis of Acute Pneumonia in Children?

The Thoracic ultrasound is a safer and sensitive technique than conventional radiography because it detects less than 1 cm pneumonic consolidations and minimal pleural effusions. The main objective is to evaluate the efficacy of thoracic ultrasound performed by unskilled personnel in the emergency service prdiatricas to diagnose pneumonia in children.

Diagnostic test evaluation.The sample collected sequentially until an exact size . Given the safety of the technique, which involves no risk to patient management and the possibility of generating a type II error by premature study discontinuation , we have no plans to make any interim analyzes .

Eligibility Criteria:
Inclusion Criteria:

* fever above 38 degrees
* tachypnea
* Difficulty breathing
* Side tip pain
* pathological auscultation

Exclusion Criteria:

* \< 3 months\> 14 years
* Background of Prematurity
* Rewalizados imaging studies in the last 7 days
* Any chronic respiratory process
* congenital heart diseases
* hemodynamic instability
* Diagnosis of pneumonia in the last 3 months
* Refusal of relatives to participate in the study
Effect and Underlying Immunological Mechanisms of Sublingual Immunotherapy in Allergic Rhinitis

Allergic rhinitis (AR) is a common Ig-E mediated disease of nasal mucosa, induced by an immunoglobulin E (IgE)-mediated reaction in the allergen-sensitized subjects, affecting 10% to 40% of the world population. AR could be divided into two kinds, perennial AR and seasonal AR (SAR). Allergen specific immunotherapy (AIT) is the only etiological treatment available for AR. Traditionally, AIT is divided into 2 types, subcutaneous immunotherapy (SCIT) and sublingual immunotherapy (SLIT), both of which are effective and safe alternatives.

The trial is a randomized, double-blind, placebo-controlled trial. 72 eligible SAR patients, who were sensitized to sweet sagewort (artemisia annua), were enrolled into the trial, followed by either a 32-week SLIT schedule, where the maintenance dose would be reached within 5 weeks, or placebo SLIT schedule. Standardized depot preparations of sweet sagewort (artemisia annua) extract (Zhejiang Wolwo Bio-pharmaceutical Co., Ltd., China ) were administered by means of sublingual drops.


Eligibility Criteria:
Inclusion Criteria:

* Male or female outpatients aged 18 to 60 years (inclusive).
* With history of SAR for at least two years, with/without conjunctivitis and asthma
* Two or more nasal symptoms scores were ≥ 2 points during July - October in the last year.
* Sensitised to artemisia annua (specific IgE level ≥ 3.5 kilounit per liter).
* Patients who have been informed of the nature and aims of the study and have given their written consent, willing to comply with the protocol.
* Patients who are able to understand the information given and the consent and complete the daily record card.

Exclusion Criteria:

* Patients whose Humulus- or Artemisiifolia-specific immunoglobulin E (IgE) levels (ImmunoCAP) same as or higher than Artemisia-specific immunoglobulin E (IgE) level.
* Patients with oral diseases/ allergies within the run-in period.
* Patients accepted any kind of operations within 4 weeks of the run-in period.
* Patients applied for systemic glucocorticoids within 4 weeks in the run-in period.
* Patients with perennial AR.
* Patients with any nasal condition that could confound the results of the study (chronic rhinitis, chronic rhinosinusitis with/without polyps).
* Whatever the co-sensitization leading to clinically relevant AR, conjunctivitis or asthma likely to significantly change the symptoms of the patient throughout the study.
* Patients with comorbidity of severe asthma.