cyrilzakka/clinical-trials huggingface dataset:
Pharyngeal Size in Patients With Obstructive Tonsils Under Orthodontic Treatment

Enlarged tonsils and malocclusion have relationship with sleep disturbance in children. The consequences of these features can include deviation of normal craniofacial growth such that this may result in a facial morphology more suitable to the development of sleep apnea later in life. The aim of this study was to compare the growth redirection, the evolution of respiratory symptoms and the pharyngeal size of snoring children with obstructive tonsils from the waiting list for surgery treated with the Bioajusta X orthodontic appliance.This new protocol of orthodontic treatment promotes maxillary expansion, mandibular advancement and proper tongue positioning on swallowing , that together may be helpful on remodeling the upper airways.

Methods-The study population included 40 children, ranging in age from 6 to 9 years old, who were on the waiting list for adenotonsillectomy at the ENT Department of FMUSP. The patients were randomly divided into two groups and were subsequently compared after a six month interval. The first group included 24 patients who where treated with the Bioajusta X appliance and the second group included 16 patients who served as controls, and,thus, did not received any treatment. Cephalometric analysis was used to assess the growth direction by comparing the relationship of the vertical jaw based upon the angle of the palatal plane with the mandibular plane (ANS-PNS/Go-M).Pharyngeal size was measured using acoustic pharyngometry. The parents filled out a questionnaire with respect to the respiratory symptoms of their children.

Eligibility Criteria:
Inclusion Criteria:

* Children 6 to 9 years of age with tonsils degree 3 or 4 ,
* Sleep snores and narrow maxilla or class II malocclusion.

Exclusion Criteria:

* Neurological diseases,
* Tooth missing ,
* Previous orthodontic treatment.
Effect of a Single Nutritional Intervention Previous to a Critical Period of Fat Gain in University Students With Overweight and Obesity

The present study aimed to investigate the effects of a single nutritional preventive session previous to a critical period linked to fat gain in university students with overweight and obesity, emulating a nutritional session of a public health system.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index \[BMI\] ≥25 kg/m2
* Not having metal plates
* Not studying Nutrition and Dietetics or Physical Education
* Not being pregnant

Exclusion Criteria:

- Presente gastrointestinal problems (vomit or diarrheas) during the three weeks that last the experiment.
Prospective Controlled Study of Posttransplant Diabetes

Research participants will be asked to undergo complete medical history, physical examination and blood tests. The purpose of these tests is to determine whether persons are predisposed to develop diabetes mellitus after kidney transplantation and also to make an early diagnosis if a patient develops diabetes mellitus. Medical information collected as part of the standard transplant evaluation and posttransplant medical care may be incorporated into this study. It is important to realize that research subjects will not be given an experimental drug as part of this study.

After kidney transplantation, research subjects will be followed in the posttransplant clinic visits. The study will last up to 6 months. During this time the subjects may be asked to participate in clinical assessment visits (medical history and physical examination), and also during the third or fourth month after transplant will be asked to do a repeat glucose tolerance test.


Eligibility Criteria:
Inclusion Criteria:

* Fasting Plasma Glucose (FPG) \<126mg/dl.
* No history of diabetes mellitus or treatment with oral antidiabetic agent or insulin.
* ESRD or chronic renal failure with CrCl \<= 20cc/min per 1.73m2.
* Waiting list registration for cadaveric or set date for living donor renal transplantation.
* Willingness and ability to understand and give informed consent.
No-touch Radiofrequency Ablation for Recurrent Hepatocellular Carcinoma Using Triple Cooled-Wet Electrodes

To evaluate local tumor progression rate at 12 months after no-touch percutaneous radiofrequency ablation using combined energy delivery mode and triple cooled electrodes


Eligibility Criteria:
Inclusion Criteria:

* Child-Pugh Class A or B
* chronic hepatitis B or chronic hepatitis C or liver cirrhosis
* presence of recurrent hepatocellular carcinoma (HCC) after locoregional treatment confirmed by pathology or imaging studies including contrast enhanced computed tomography (CT) or magnetic resonance imaging (MRI) according to Liver Imaging Reporting and Data System (LI-RADS) v2018
* single lesion less than or equal to 5 cm, or up to 3 lesions, each greater than less than or equal to 3 cm at the time of locoregional treatment

Exclusion Criteria:

* number of recurrent HCCs, equal or more than 3
* largest recurrent HCC size over 3 cm
* presence of vascular invasion by HCC
* platelet count less than 40,000 per mm3 or International Normalized Ratio (INR) prolongation over 50%
* presence of extrahepatic metastasis
Anti-diabetic Effect of Gynostemma Pentaphyllum Tea in Type 2 Diabetic Patients

The aim of the present study was to investigate the long-term effects on blood glucose concentrations and possible adverse effects of an extract of Gynostemma pentaphyllum (GP). This is a plant growing in the mountain regions of Northern Vietnam and previously being used in traditional medicine. The GP extract, or placebo, was randomized to newly diagnosed patients with type 2 diabetes and administered as a "tea", 3 g two times daily during 12 weeks. All patients received instructions regarding diet and physical exercise. Oral glucose tolerance tests were performed at baseline and then every 4 weeks, and blood tests were taken with the purpose to monitor lipids, kidney and liver function, body weight and blood pressure.

In Vietnam, herbal extracts have been used as a long-standing tradition to treat diabetic patients, but effects of these extracts have not been studied adequately. Based on previous results in experimental animals, we have selected the plant Gynostemma pentaphyllum (GP), which grows in the mountain region of Northern Vietnam. GP extract had a hypoglycemic effect on mice and rats, and was shown to contain a substance, phanoside, which stimulates insulin secretion. In addition, GP has been shown to reduce both hyperglycemia and hyperlipidemia in diabetic Zucker fatty rats.

The present study aimed at investigate effects of GP extract, administered as a "tea", and compared with placebo in a randomized, double-blind trial in drug-naive patients with newly diagnosed type 2 diabetes. All patients also received instructions about diet and physical exercise. In addition to monitoring effects on plasma glucose regulation, we also studied possible effects on plasma lipids, kidney and liver function as well as body weight and blood pressure.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed, drug-naive patients with type 2 diabetes
* Fasting plasma glucose (FPG) 7.0-14.0 mmol/l
* HbA1c \> 6%

Exclusion Criteria:

* Type 1 diabetes
* Liver failure
* Kidney Failure
Pharmacokinetics, Safety, and Tolerability of rhEGF Eye Drops in Healthy Male Subjects

A randomized, double-blind, placebo-controlled, single ascending dose and multiple ascending dose study of the Pharmacokinetics, safety, and tolerability of rhEGF eye drops in healthy male subjects

Primary Objective: To evaluate safety and tolerability of rhEGF eye drop/ Secondary Objective: To evaluate PK of rhEGF eye drop

Eligibility Criteria:
Inclusion Criteria:

* Healthy male aged from 20 to 51 at screening test
* Weight 50kg \~100kg BMI 18-27
* Those who are fully understood, voluntarily decided to participate and signed prior to screening
* Those who are deemed suitable for participating in clinical trial due to lab tests, physical exam etc

Exclusion Criteria:

* Those who have clinically significant liver, kidney, respiratory, endocrine, neurologic diseases or hematologic disease, mental diseases(mode disorder, obsessive compulsive disorder)
Cefiderocol PK in Patients on ECMO

Extracorporeal membrane oxygenation (ECMO) is a form of cardiopulmonary life-support for critically ill patients where blood is extracted from the vascular system and circulated by a mechanical pump while it is oxygenated and reinfused into the patient's circulation. It is well known that critically ill patients may experience alterations in antibiotic pharmacokinetics, and as a result, dosing modifications are generally required. There is a need to understand how ECMO circuits affect the pharmacokinetics and disposition of drugs. This study is designed to assess the pharmacokinetics of the new broad-spectrum antibiotic, Cefiderocol, in critically ill patient receiving ECMO.

This is a prospective, open-label, Phase 1b, pharmacokinetic study of Cefiderocol in 8 critically ill patients receiving ECMO support at Hartford Hospital. Informed consent will be collected from all study participants, legal authorized representative, or their next of kin in order to participate. This is not a treatment study; all participants will receive other antibiotics as necessary to treat any current infection.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* On support with veno-venous- or veno-arterial-ECMO

Exclusion Criteria:

* Females who are pregnant or breast-feeding
* History of any moderate or severe hypersensitivity or allergic reaction to any β-lactam antibiotic (a history of mild rash to a cephalosporin followed by uneventful re-exposure is not a contraindication)
* Receiving Cefiderocol to treat documented or suspected infection within 72 hours of screening, or expected to receive Cefiderocol during the study intervention phase
* Severe renal dysfunction defined as a CrCL \< 15 mL/min (as calculated by the Cockcroft Gault equation using actual body weight) or requirement for continuous renal replacement therapy or hemodialysis
* A hemoglobin less than 7.2 gm/dl at baseline
* Acute liver injury, defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 5 times the upper limit of normal, or AST or ALT \> 3 times the upper limit of normal with an associated total bilirubin \> 2 times upper limit of normal
* Any rapidly progressing disease or immediately life-threatening illness (defined as imminent death within 48 hours in the opinion of the investigator)
* Any condition or circumstance that, in the opinion of the investigator, would compromise the safety of the patient or the quality of study data.
Anticoagulation in AF Ablation and Effects on Neurocognitive Function

Atrial fibrillation (AF) is the most common cardiac arrhythmia in the United States, and treatment by AF ablation is quickly becoming the favored definitive therapy. Nonetheless, AF ablation comes with some risk, including bleeds related to vascular access and myocardial damage, as well as the rare incidence of clinical stroke from blood clots that travel from the heart to the brain, termed "cerebrothromboemboli." In fact, cerebrothromboemboli without any symptoms have been detected by special imaging procedures called brain magnetic resonance imaging (MRI) in as many as 22% of cases.(1-6) There remains clinical equipoise amongst experts regarding balancing the risks and benefits of continued versus interrupted blood thinning, or "anticoagulation" during AF ablation as they pertain to risk of bleed and cerebrothromboemboli prevention, respectively, and the potentially more subtle sequelae of these apparently silent cerebrothromboemboli remain unknown. In fact, both interruption and continuation of anticoagulation during AF ablation are the standard of care. The investigators will perform the first randomized trial of uninterrupted versus interrupted anticoagulation in patients undergoing AF ablation to determine if it mitigates neurologic injury. The objective of this research is to investigate the effect of continued anticoagulation for AF ablation on cerebrothromboemboli, and the neurocognitive sequelae of embolic lesions, which to this point are considered subclinical. The investigators hypothesize that continued anticoagulation will both reduce cerebrothromboemboli and mitigate any potential decline in neurocognitive function post-procedurally. The investigators also hypothesize that the incidence of cerebrothromboemboli (CTE) by MRI will mediate that difference.


Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years old and older with AF (paroxysmal or persistent) who are to undergo an elective AF ablation procedure at UCSF will be eligible for enrollment.

Exclusion Criteria:

* Patients will be excluded if they have:
* A contraindication of warfarin therapy (pregnancy, recent bleed, inability of have serial INR checks)
* A contraindication or relative contraindication to interruption of anticoagulation (e.g. mechanical valve, clotting disorder such as antiphospholipid syndrome, recent history of pulmonary embolism or history of recurrent pulmonary embolism)
* A contraindication to transesophageal echocardiogram; any contraindication to MRI
* Have a diagnosed condition of dementia or a diagnosis that precludes accurate assessment of neurocognitive function
* Non-English speakers
* Inability to give informed consent.
Foot Muscles Training in Sclerosis

The study tries to assess the efficacy of an 8-week IFM training programme on stability in patients diagnosed with Multiple Sclerosis


Eligibility Criteria:
Inclusion Criteria:

* Patients with moderate neurological disability as scored by the Expanded Disability Status Scale (EDSS), ranging from 3.0 to 6.0

Exclusion Criteria:

* Cognitive disturbances that could affect the performance of any of the tests or questionnaires included in the study
* Diagnosis of visual or vestibular disorders that could affect patient stability
* Change in Multiple Sclerosis-specific medication in the 2 months prior to the start of the study
* Acute relapse in the 2 months prior to the start of the study
* Traumatologic or orthopaedic disorders that could negatively affect balance.
Use of Domperidone for Treatment of Upper Gastrointestinal Disorders

This is an Expanded Access to Investigational Drug program available through the FDA. Some specific conditions to qualify for this program includes gastroesophageal reflux disease with upper GI symptoms, gastroparesis, and chronic constipation. Patients failing standard therapies for these conditions may be eligible to receive domperidone. This program facilitates availability of investigational drugs, (such as domperidone) to patients with serious diseases or conditions when there is no comparable or satisfactory alternative therapy to diagnose, monitor or treat the patients's disease or condition. Authorization must be obtained from FDA prior to the importation, interstate shipment and administration of domperidone.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female
2. Age 18 and older
3. Symptoms or manifestations secondary to motility disorders of the upper GI tract. These include gastroparesis, functional dyspepsia, gastroesophageal reflux disease that are refractory to standard therapy.
4. Patients must have a comprehensive evaluation to eliminate other causes of their symptoms. This includes a history and physical examination. A recent (within 3 years) evaluation of the upper GI tract with either upper endoscopy or upper GI radiographic series. Baseline blood tests suggested are electrolytes, magnesium, and prolactin level.
5. Patient has signed informed consent for the administration of domperidone that informs the patient of potential adverse events including:

   * Increased prolactin levels
   * Breast changes
   * Extrapyramidal side effects
   * Cardiac arrhythmias including QT prolongation (increased risk with the drugs listed in the appendix)

Exclusion Criteria:

History of, or current, arrhythmias including ventricular tachycardia, ventricular fibrillation and Torsade des Pointes. Patients with minor forms of ectopy (PACs) are not necessarily excluded.

2. Clinically significant bradycardia, sinus node dysfunction, or heart block. Prolonged QTc (QTc \> 450 milliseconds for males, QTc \> 470 milliseconds for females).

3. Clinically significant electrolyte disorders. These include significant hypokalemia, hyperkalemia, hypomagnesemia, and hypermagnesemia that cannot be corrected with treatment of these electrolyte abnormalities.

4. Gastrointestinal hemorrhage or obstruction. 5. Presence of a prolactinoma (prolactin-releasing pituitary tumor). 6. Pregnant or breast feedings female. 7. Known allergy to domperidone.
Efficacy and Safety of Ustekinumab in Bullous Pemphigoid

Bullous pemphigoid (BP) is an autoimmune subepidermal blistering disease and typically affects the elderly. Clinically, BP is an intensely pruritic erythematous eruption with widespread blister formation. BP is usually a chronic disease, with spontaneous exacerbations and remissions, which may be accompanied by significant morbidity.

BP usually requires on average a 1-year duration of treatment. Superpotent topical corticosteroids have been demonstrated to be effective. Despite their high efficacy, topical corticosteroids are often considered as poorly convenient, requiring the assistance of patients' relatives or a nurse to apply the topical treatment on a long period of time.

Overall, whereas BP lesions can be adequately and rapidly controlled with either topical corticosteroids, there is a high need for a safe maintenance therapy to avoid treatment side effects due to cumulative doses of corticosteroids over months.

Newer therapeutic agents such as ustekinumab targeting molecules involved in the inflammatory cascade associated with BP represent future alternatives to classical immunosuppressant drugs for maintenance therapy.

The aim of the study is to evaluate efficacy of ustekinumab in association during 8 weeks with superpotent topical corticosteroids in patients with bullous pemphigoid

Eligibility Criteria:
inclusion criteria :

* patient with bullous pemphigoid
* patient aged between 18 and 90
* patient with Karnofsky Performance score \> 60%
* patient agreed to participate to the study

exclusion criteria :

* patient with allergy to corticosteroids
* patient with allergy to ustekinumab
* patient with any severe medical condition at time of inclusion including stroke, heart failure, renal failure, high blood pressure and diabetes mellitus
* malignancy \< 5 years prior to inclusion
* pregnant or nursing (lactating) women, or women of child-bearing potential
* active infection or with recent history of clinically significant infection within 4 weeks prior to inclusion
* history or presence of infection with hepatitis B or C.
* history or presence of immunodeficiency diseases, including a positive HIV (ELISA and Western blot) test result.
Compare the Efficacy of Acupuncture Therapy and Carbamazepine Oral Dosage in Patients With Carpal Tunnel Syndrome by Multiple Excitability Test

The goal of the study is to utilize BCTQ(Boston Carpal Tunnel Questionnaire), VAS (Visual Analog Scale), NCS (Nerve Conduction Study), and MET(Multiple Excitability Test) to evaluate and compare the efficacy of Acupuncture Therapy and Carbamazepine in Patients with Carpal Tunnel Syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Age greater than 20 years old
* outpatient or inpatient subject with numbness of arm, clinically met diagnostic criteria of AAEM(American association of Electrodiagnostic Medicine CTS task force), and proven to have distal motor neurological disorder through nerve Conduction Study (distal motor latency \>4.6 msec, decreased SNAP \< 12uV or prolonged median sensory distal latency (palm to wrist) \> 2.5msec)。
* Willing to sign the Informed Consent form

Exclusion Criteria:

* subject with external hand injury or disformation
* subject with Polyneuritis or Cervical nerve root lesions
* Subject with peripheral hypertrophy, hypothyroidism, multiple myeloma, or amyloidosis
* Allergic to Carbamazepine or similar type of medicine
* inability to act independently, or in the opinion of the investigator, not suitable for the study
* In the opinion of the investigator, the subject requires surgical repair of the Carpal Tunnel Syndrome, or the symptoms will be worsen result in irreversible damage to the subject if not treated with surgical repair within 3 months.
Maximizing the Initial Experience of a Neophyte Scleral Lens Wearer

The goal of this proposal is to conduct a randomized controlled study aimed at learning the best method for applying scleral lenses and factors associated with successfully completing scleral lens application and removal training.

Scleral lens (SL) prescribing has dramatically increased over the past few years likely because of the advent of better SL designs, better materials, and greater awareness of the technology. SL market growth has also likely increased because SLs were once reserved for patients with complex ocular surface diseases, though advances with SL technologies have allowed SL fitting to include patients with dry eye and even patients who have relatively uncomplicated refractive errors. While SLs are maintained and cared for much like soft contact lenses (e.g., they require a contact lens care system), SL wearers also need help with applying their lenses. Patients specifically are advised by their care provider to insert their SLs with their fingers (tripod method), a DMV inserter with an open or closed end (hole potentially aides in vision), or a specialized o-ring that is balanced on a finger. Our clinic also utilizes a tea light candle with a DMV inserter attached to the top of it when patients have mobility issues. While work from this investigator's study group has found that 54% of patients prefer DMV inserters for applying their SLs as compared to the above other options, these preliminary data were obtained through a cross-sectional electronic survey from subjects who completed their SL fitting up to two years ago. Therefore, the goal of this proposal is to conduct a randomized controlled study aimed at learning the best method for applying SLs and factors associated with successfully completing SL application and removal training. These data are needed because it will help practitioners with patient education and because it may increase the likelihood that patients will be successful with SLs.

Eligibility Criteria:
Inclusion Criteria:

* Adults (\>18 years)
* Must have an indication for needing scleral lenses

Exclusion Criteria:

* Participating in another research study
* Unable to attend multiple visits
* Advanced knowledge or past use of scleral lenses
* A physical or mental condition that would prevent the subject from applying their own scleral lenses
Pulmicort Respules(Budesonide Inhalation Suspension) vs Singulair, Children

A one year study comparing the safety and effectiveness of Pulmicort (0.5mg strength given once a day in the evening) with either 4 or 5mg strength SINGULAR (given once a day in the evening) in children with asthma aged 2 to 8. If allocated to SINGULAR treatment, children aged between 2 and 5 will receive 4mg strength SINGULAR and those aged between 6 and 8 will receive 5mg strength SINGULAR.


Eligibility Criteria:
Inclusion Criteria:

* Aged 2 to 8 at study entry
* At least 3 episodes of wheezing in the previous year that lasted more than 24 hours and affected sleep or symptoms of mild persistent asthma
* use of b-2 agonist treatment on at least 3 of 7 consecutive days or run in

Exclusion Criteria:

* Severe or unstable asthma
* any significant finding at a physical exam
* an exacerbation of asthma in the 30 days before entering the study that might affect study results in judgement of the study doctor