cyrilzakka/clinical-trials huggingface dataset:
Growth, Dietary Intakes and Feeding Behaviors of Children With Cerebral Palsy Who Have Chewing Disorders

The nutritional status of CP children may be decreased when children have chewing disorders too due to insufficient solid food intake. The objective of this study was to investigate growth, dietary intakes and feeding behaviours of children with CP who have chewing disorders, and to compare them with their healthy peers.

Chewing function is defined as a rhythmic oral motor activity to comminute and soften solid food. Children with CP often have difficulty in transitioning to solid food. The main food of 45% of them was liquids and semisolids. It was reported that food/fluid textures were modified for 39% of children in which with poorer gross motor function tended to receive a greater proportion of energy from fluids in their diets and fewer chewable foods. Lopes et al. investigated dietary patterns of 90 children with CP aged 2-13 years by using the 24-hour recall method and found that 26% and 9% of children had difficulty in chewing and swallowing of solid foods, respectively. However, the diet of children with normal feeding skills includes liquid, semisolid and/or solid foods together so unable to take any solid food may affect sufficient food intake and nutritional status of children with CP who have chewing disorders. The significance of this situation is that nutritional status has effects on general health and quality of life of children and their families. Therefore, it is important to show the nutritional status of CP children with chewing disorders to increase the awareness of both parents and healthcare providers on solid food intake and solve the problem early. The objective of this study was to investigate growth, dietary intakes and feeding behaviours of children with CP who have chewing disorders, and to compare them with their healthy peers.

Eligibility Criteria:
Inclusion Criteria:

Study group

* Children with cerebral palsy
* Having complaints about chewing function
* Do not manage solid food intake
* Above the age of 18 months Control group
* Healthy children
* No complaints about chewing function
* Can manage solid food intake
* Above the age of 18 months

Exclusion Criteria:

* Under the age of 18 months
* Requiring tube feeding or taking any oral nutritional supplements
* Using any medicine and/or oral appliances that could affect the chewing performance
Screening Microorganism of Cryptogenic Mechanical Pneumonia Through Next Generation Sequencing to Lung Tissue Fluid

The etiology of cryptogenic organizing pneumonia (COP)was not clear, but previous studies have shown that in some patients, some pathogen could be detected in bronchoalveolar lavage fluid (BALF), and may be one of the causes of COP. This study aimed to screen the pathogenic microorganisms in BALF and lung puncture fluid of the patients with COP through the next-generation sequencing to further clarify the correlation between the incidence of COP and pathogenic microorganisms.

The cause of cryptogenic organizing pneumonia (COP) was unknown, but studies had shown that certain bacteria, viruses, or specific pathogens could be detected in bronchoalveolar lavage fluid (BALF) in some patients, and these pathogenic microorganisms may be the cause of COP. Specimens were obtained by conventional methods (sputum, blood, BALF or lung puncture fluid) for microbiological detection. Due to the influence of the quality of acquired specimens, specimen preservation and transportation which were influenced by external factors, many patients did not get good test results, which affected the diagnosis and subsequent treatment of patients. Next-generation sequencing (NGS) which could determine hundreds of thousands to millions of DNA molecules in parallel at one time, and efficiently sequence or fragment of pathogenic microorganisms. NGS had greatly improved the detection rate of pathogenic microorganisms. This study aimed to screen pathogenic microorganisms in BALF and lung puncture fluid of COP patients by NGS, and further clarify the correlation between occurrence of COP and pathogenic microorganisms.

Eligibility Criteria:
Inclusion Criteria:

1. The patient was older than 18 years old.
2. The patient was organizing pneumonia (OP) through pathology.
3. The patient was diagnosed as OP from clear cause through routine detection.
4. Chest CT shows consolidation or ground glass

Exclusion Criteria:

1. The patient has specific characteristics of connective tissue disease or autoimmune disease.
2. The patient has a clear other cause of OP.
3. The patient has severe systemic diseases of heart, brain, liver, kidney and so on, and cannot tolerate invasive examination
4. The patient disapproves of invasive testing
Wellness for 2: Understanding How to Foster Well Being for Mom and Her Baby

This NICHD-funded RCT will enroll up to 178 depressed pregnant women, randomly assigning them to one of 2 intervention conditions: (1) a gentle prenatal yoga program (PYP), or (2) a series of educational workshops focused on perinatal health, the Mom and Baby Wellness Workshop (MBWW), each condition lasting 9 weeks. The investigators will clinically monitor all participants in the study for safety and clinical deterioration, and measure a variety of symptom outcomes over the course of the intervention period during pregnancy, as well as at a postpartum follow-up.

In this randomized controlled trial, eligible women will be randomly assigned to either a 9-week Prenatal Yoga Program (PYP) vs. a 9-week health education control group, the Mother-Baby Wellness Workshop (MBWW). Follow up assessments will take place at multiple points during the study. The primary study outcome will be severity of prenatal depression assessed by a blind interviewer. The investigators will examine relevant secondary outcomes (self-reported depression, anxiety, functioning, \& pain; pre-term birth) and potential mediators (inflammation, mindfulness/non-judgment).

Eligibility Criteria:
Inclusion Criteria:

1. Healthy singleton pregnancy, 12-27 weeks gestation
2. Medically cleared for moderate exercise
3. Depression symptoms in moderate range. Participants must have an Quick Inventory of Depressive Symptoms (QIDS; \[119\]) score between 8-20
4. English-speaking
5. Aged 18 or older

Exclusion Criteria:

1. New or unstable depression treatment
2. Currently a regular yoga practitioner
3. Bipolar disorder, schizophrenia, psychotic depression, chronic psychosis
4. Current hazardous drug or alcohol use
5. Acute suicidality
Gemini Symbicort pMDI

The purpose of this study is to determine whether treatment with Symbicort for 12 weeks will improve lung function and symptoms of adults and adolescents with asthma.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of asthma
* Baseline lung function tests as determined by protocol.
* Required and received treatment with inhaled corticosteroids and/or lung treatments specified in the protocol within timeframe and doses specified in protocol.

Exclusion Criteria:

* Severe asthma
* Has required treatment with any non-inhaled corticosteroid within previous 4 weeks, has sensitivity to drugs specified in the protocol or requires treatment with beta-blockers
* Had cancer within previous 5 years or currently has any other significant disease or disorder as judged by the investigator
Effectiveness, Safety and Feasibility of HECT-CL, in Quetta, Pakistan

This research studies the effect thermotherapy as treatment of Old World CL which is not invasive, non-toxic, and the short treatment. While the current standard treatment comprise daily painful injections with antimonials,

The current standard treatment for Old World CL is based on daily painful injections with antimonials, which in Pakistan requires specialised care provided in secondary level care facilities.

Apart from potential toxic side effects of these antimonials, the long treatment course, high cost and inconvenience, it may prevent patients from seeking care or completing treatment, especially women and children in the Pakistan context. Untreated cutaneous leishmaniasis may leave disfiguring scars leading to stigmatisation and (psycho) social problems. If the CL lesions/scars are located on joints they can cause problems in motion and lead to disability. At a public health level, patients with untreated CL lesions are a reservoir for further transmission of CL in the family and community.

Thermotherapy is topical, not invasive, non-toxic, and the treatment duration is only 7 days, and therefore is expected to have major benefits for patients.

Additional advantages are that the HECT-CL can be applied by lower level qualified health workers, and the costs are low (less than 3 USD) per re-usable heat pad), and therefore can be rolled out to peripheral health facilities, potentially having a major impact on access to treatment.

Eligibility Criteria:
Inclusion criteria

* Patients with clinical CL symptoms for less than 6 months with the diagnosis confirmed by microscopic visualisation of Leishmania parasites in skin scrape smear.
* Patients who have given written informed consent.

Exclusion criteria

* Patients presenting with CL lesions located on or within two centimetres of eyes and lips.
* Patients with more than four lesions.
* Lesions, nodules and/or ulcerations with a diameter (ø) of more than 6 cm.
* Patients with persistent lesions for more than 6 months.
* Patients younger than 10 years.
* Patients who are unlikely, unable or unwilling to be available for and comply to regular follow up visits for 6 months.
* Pregnant, and lactating women \<6 months after delivery.
* Patients with uncontrolled medical illnesses.
* Patients with immune disorders, such as HIV/AIDS, or those who are on steroid medication
Impact of the Type of Reconstruction Methods on Diabetes Following Laparoscopic Distal Gastrectomy in Patients With Gastric Cancer and Type 2 Diabetes

There is a rapidly growing interest in metabolic surgery for the treatment of type 2 diabetes. However, its efficacy in the non-morbidly population is not clear yet and the underlying mechanism remains elusive.

Meanwhile, the incidence of early gastric cancer (EGC) in Korea has gradually increased, the long-term quality of life of the patients with EGC has become an important issue. Since the reconstruction methods after gastric cancer surgery are similar to that of metabolic surgery, some surgeons have attempted to modify the reconstruction methods after standard radical gastrectomy to achieve better glycemic control in gastric cancer patients with type 2 diabetes.

The present study aimed to investigate the changes in glucose metabolism and incretin hormone responses following different types of reconstruction after distal gastrectomy in non-morbidly obese gastric cancer patients with type 2 diabetes. This is a non-randomized, prospective, single-center, phase II pilot study.

Patients diagnosed with stage I gastric cancer and type 2 diabetes are eligible for the present study. Patients who will undergo laparoscopic distal gastrectomy for cancer located at the lower two-thirds of the stomach will only be included. The reconstruction method will be selected among conventional Billroth I, long-limb Billroth II (with 100 cm-long biliopancreatic limb), or long-limb Roux-en-Y (with 100 cm-long Roux limb) reconstruction methods according to the surgeon's preference as well as the size of the remnant stomach. All the patients are subjected to a 75g-oral glucose tolerance test (OGTT) preoperatively, and at 5 days, 3 months, 6 months postoperatively and serum glucose, as well as incretin hormones, will be serially measured.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with type 2 diabetes as well as pathologically proven gastric cancer of clinical stage I according to the AJCC 7th edition
* Those who are expected to undergo laparoscopic distal gastrectomy
* Body mass index \< 30 kg/m2

Exclusion Criteria:

1. baseline fasting C-peptide level \< 1.0 ng/dL (who had the possibility of type 1 diabetes)
2. previous radiotherapy or surgery at upper abdomen other than laparoscopic cholecystectomy
3. other malignancies in recent 5 years
4. vulnerable patients (pregnant women, those with cognitive impairment, etc)
5. ECOG-PS ≥ 2
6. participating in other clinical trials within 6 months
Safety and Bioactivity of AXT107 in Subjects With Neovascular Age-Related Macular Degeneration

This is an open-label, dose-escalating, 48-week study assessing the safety, tolerability, bioactivity and duration of action of a single intravitreal injection of 0.1 mg, 0.25 mg, or 0.5 mg AXT107 in approximately 18 subjects (up to 6 subjects per dose) with nAMD.

Upon providing informed consent, subjects will be sequentially enrolled into the study. Decision regarding dose escalation will be based on the recommendation from the Data Monitoring Committee (DMC). The first 3 eligible subjects will receive the low dose of AXT107 injection. After the 3 low dose subjects complete a 7-day follow-up, the DMC will review their safety data. If an acceptable safety profile is determined by the DMC, 3 additional subjects will be enrolled to receive the mid dose of AXT107 injection. Upon completion of a 7-day follow-up, review of the safety data, and determination of an acceptable safety profile by the DMC for the mid dose subjects, 3 additional subjects will be enrolled to receive the high dose of AXT107 injection.

Eligibility Criteria:
Inclusion Criteria:

* Patients 50 years of age or older diagnosed in the study eye with subfoveal choroidal neovascularization (CNV) or juxtafoveal CNV secondary to AMD
* Best corrected visual acuity (BCVA) Early Treatment Diabetic Retinopathy Study (ETDRS) letter score of 65 to 10 in the study eye
* Willing and able to comply with clinic visits and study-related procedures
* Provide signed inform consent

Exclusion Criteria:

* Macular edema or CMV secondary to any causes other than AMD in the study eye
* Previously-treated patients who are not responders to anti-VEGF
* Any condition that may preclude improvement in visual acuity in the study eye
* Previous vitreoretinal surgery, filtration surgery, and cataract surgery within 3 months in the study eye

Note: Other inclusion/exclusion criteria apply
Role of Interferon-gamma 1-b (IFN-γ) on Cells of the Innate Immune System: Functional, Biochemical and Gene Expression Studies in Patients With Chronic Granulomatous Disease

The overall goal of the study is to investigate the functional, biochemical, and gene expression effects of Interferon-gamma 1-b (IFN-γ) on the neutrophils of patients with Chronic Granulomatous Disease (CGD). The investigators hypothesize that the clinical effects demonstrated in patients with CGD treated with IFN-γ (decreased number and severity of infections) are the result of biochemical processes and upregulation of specific genes, which lead to enhanced functionality of this immune cell population.


Eligibility Criteria:
Inclusion Criteria:

* Current treatment with IFN-γ or intent to treat with this drug
* Acute infections resolved
* Subject is off treatment medications
* Women of childbearing potential must have:

  * a negative urine beta-HCG, and
  * be willing to practice two forms of effective contraception for the duration of study participation

Exclusion Criteria:

* Pregnancy,
* Breast-feeding, or
* Unwillingness to use effective contraception
* Recent vaccination (within the last fourteen days)
* Current infection or acute health condition requiring treatment
* Chronic inflammatory complications of CGD including:

  * gastric outlet or urinary tract obstruction,
  * pleuritis,
  * pericarditis,
  * inflammatory bowel disease, or
  * colitis requiring treatment.
* Un-associated chronic lung, liver, kidney, or cardiac disorders requiring active treatment
Balance and Mild Traumatic Brain Injury (TBI)

The purpose of this pilot project is to determine whether using one inertial sensor on the waist during routine clinical balance testing (i.e. Balance Error Scoring System (BESS)), will be a more immediate, objective, reliable and sensitive way to measure and quantify balance deficits in individuals with mild Traumatic Brain Injury (mTBI).

The purpose of this pilot project is to gather preliminary data to determine whether using one inertial sensor at the waist during the BESS could provide the examiner with a more immediate, objective, reliable and sensitive way to quantify deficits in postural control in the post-concussive population. The investigators hypothesize that the metrics obtained from the iSWAY will be better able to distinguish mTBI subjects from control subjects than the standard clinical assessment. The specific aims are:

1. To determine test-retest and inter-rater reliability of the clinical BESS compared to the instrumented BESS test.
2. To determine if an instrumented BESS can distinguish mTBI from age-matched control subjects better than the commonly used BESS and to determine the best metrics of sway to separate groups.

Eligibility Criteria:
Inclusion Criteria:

* Have a mild Traumatic Brain Injury or Concussion
* Between the ages 12-40 years

Exclusion Criteria:

* Out of age range
AMES Treatment of the Impaired Leg in Chronic Stroke Patients

The purpose of this protocol is to determine if individuals who had a stroke more than one year before entering the study and whose ankles remain substantially impaired are able to sense and move the affected leg better after 9-13 weeks of treatment with a robotic therapy device (AMES).

Our research objective is to develop procedures to rehabilitate those stroke patients who, through conventional therapies, are not brought to a level of maximal recovery. The aims of the proposed project are to obtain a set of data from a total of 20 chronic stroke subjects, all with severe lower extremity disability, between the ages of 18-85, using a robotic therapeutic device placed in a rehabilitation clinic. This data will allow us to quantify the extent to which a combination of robotic-assisted exercise and tendon vibration from the AMES beta device induces secondary recovery from the effects of stroke on the lower extremity.

Eligibility Criteria:
Inclusion Criteria:

* Spastic hemiparesis
* At least 12 months post-stroke
* Can comfortably fit foot in treatment device
* Functioning proprioception
* Fugl-Meyer LE score \>6 and \<23
* Minimal hemi-neglect
* Observable volitional movement of the ankle in either plantar- or dorsi-flexion
* Cognitively and behaviorally capable of complying with the regimen

Exclusion Criteria:

* Fractures of treated limb resulting in loss of range of motion
* Spinal cord injury
* Deep venous thrombosis
* Peripheral nerve injury or neuropathy in the affected limb with motor disability
* Osteoarthritis limiting range of motion
* Uncontrolled high blood pressure/angina
* Exercise intolerant
* Skin condition not tolerant of device
* Progressive neurodegenerative disorder
* Uncontrolled seizure disorder
* Botox treatment within last 5 months
* Baclofen pump
Safety and Immunogenicity of a Commercially Available Influenza Vaccine (Formulation 2007/2008) When Administered to Elderly Subjects

To evaluate the antibody response to each influenza vaccine antigen when administering a single dose to subjects aged 65 years and over


Eligibility Criteria:
Inclusion Criteria:

- 65 years of age or older

Exclusion Criteria:

* any serious disease such as cancer, autoimmune disease, advanced arteriosclerotic disease or insulin-dependent diabetes mellitus, chronic obstructive pulmonary disease (COPD) that requires oxygen therapy, acute or progressive hepatic disease, acute or progressive renal disease, congestive heart failure and bleeding diathesis or conditions associated with prolonged bleeding time
* hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or kanamycin or any other component of the vaccine
* history of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine
* known or suspected (or high risk of developing) impairment/alteration of immune function
* any acute disease or infections requiring systemic antibiotic or antiviral therapy within the past 7 days
* fever within the past 3 days
Adjunctive Methods In Treatment Of Odontogenic Keratocyst

The purpose of this study was to compare both clinically and radiographically the effect of using 5- fluorouracil cream (5-FU) versus modified carnoy's solution (MCS) as adjunctive methods in treatment of odontogenic keratocyst (OKC).

Patients and methods :This is an interventional, comparative study that was carried on 20 patients with mandibular odontogenic keratocyst and were divided randomly into two equal groups, Group I: included 10 patients in whom OKCs were treated with enucleation and peripheral ostectomy followed by application of 5-FU cream. Group II: included 10 patients in whom OKCs were treated with enucleation and peripheral ostectomy followed by application of MCS. All patients were followed up for 9 months postoperatively.


Eligibility Criteria:
Inclusion Criteria:

* patients with biopsy proved odontogenic keratocyst

Exclusion Criteria:

* relevant systemic diseases which might affect healing process.
Ascending Dose Study of Genome Editing by the Zinc Finger Nuclease (ZFN) Therapeutic SB-913 in Subjects With MPS II

The purpose of the study is to evaluate the safety, tolerability and effect on leukocyte and plasma Iduronate 2-Sulfatase (IDS) enzyme activity of ascending doses of SB-913. SB-913 is an intravenously delivered Zinc Finger Nuclease (ZFN) Therapeutic for genome editing. It inserts a correct copy of the IDS gene into the Albumin locus in hepatocytes with the goal of lifelong therapeutic production of the IDS enzyme.

The objectives of the study are to provide long term expression of IDS and improve the current clinical outcome of enzyme replacement therapy (ERT) in subjects with MPS II, a recessive lysosomal storage disorder that results from mutations in the gene encoding IDS. SB-913 is a therapeutic for ZFN-mediated genome editing which will be delivered by adeno-associated virus (AAV)-derived vectors. SB-913 is intended to function by placement of the corrective copy of IDS transgene into the genome of the subject's own hepatocytes, under the control of the highly expressed endogenous albumin locus, and is expected to provide permanent, liver-specific expression of Iduronate 2-Sulfatase for the lifetime of an MPS II patient.

Eligibility Criteria:
Inclusion Criteria:

* Male or female 5 years to 65 years of age.
* Clinical diagnosis of MPS II (based on evidence of hepatosplenomegaly, dysostosis multiplex by X-ray, valvular heart disease, or obstructive airway disease) IDS deficiency confirmed by gene sequencing.

Exclusion Criteria:

* Known to be unresponsive to ERT
* Neutralizing antibodies to AAV 2/6
* Serious intercurrent illness or clinically significant organic disease (unless secondary to MPS II)
* Receiving antiviral therapy for hepatitis B or C, or with active hepatitis B or hepatitis C or HIV 1/2
* Lack of tolerance to idursulfase treatment with significant IARs or occurrence of anaphylaxis
* Markers of hepatic dysfunction
* Creatinine ≥ 1.5 mg/dL
* Contraindication to the use of corticosteroids for immunosuppression
* Current treatment with systemic (IV or oral) immunomodulatory agent or steroid use (topical treatment allowed)
* Participation in prior investigational drug or medical device study within the previous 3 months
* Prior treatment with a gene therapy product
* Elevated or abnormal circulating α-fetoprotein (AFP)
* Weight \< 20 kg at Screening Visit