cyrilzakka/clinical-trials huggingface dataset:
Frenuloplasty for Speech and Myofunctional Outcomes

Children with ankyloglossia (tongue tie) can have abnormal tongue function, putting them at a disadvantage when it comes to speech and articulation. Furthermore, abnormal tongue posture within the oral cavity increases the likelihood of myofunctional disorders.

The current body of literature surrounding ankyloglossia and speed delay is mixed. The literature base is riddled with retrospective reviews, poor descriptions of surgical intervention, and the lack of standardized grading schemes with respect to articulation. Furthermore, the candidacy for intervention in these instances only involves children with anterior tongue tie. There is a complete lack of investigation surrounding the impact of posterior tongue tie on articulation.

The other area that has inadequately been studied is the impact ankyloglossia has on myofunctional outcomes. There are data now that demonstrate how ankyloglossia is correlated with a vaulted palate and has long term orthodontic consequences. This study aims to demonstrate how release of posterior tongue tie improves lingual strength and posture.

Eligibility Criteria:
Inclusion Criteria:

* Children ages 5-12 with posterior tongue tie who are undergoing treatment just for ankyloglossia
* Children must already be working with an SLP who has done a speech and myofunctional evaluation

Exclusion Criteria:

* Children undergoing other procedures at the same time as the frenuloplasty (tonsillectomy, adenoidectomy, etc)
* Significant medical comorbidities (cardiovascular, neurological, etc)
* Anterior tongue tie or lip tie
* Previous lingual surgery
Different Effects of Non-calcium Phosphate Binders on Serum Calcium

Sevelamer hydrochloride (SE) can increase intestinal calcium absorption in contrast to lanthanum carbonate (LA). Study compared effect of LA and SE on serum and urine phosphate and calcium, and hormones regulating mineral-bone metabolism.

Recent experimental studies have shown that a non-calcium based phosphate binder sevelamer hydrochloride can increase intestinal calcium absorption in contrast to lanthanum carbonate. It is unknown whether such the difference may have an effect on bone metabolism and/or modify the development of vascular calcification in patients with chronic kidney disease. The aim of the study was to compare the effect of a single dose of 1000 mg of lanthanum carbonate with 2,4 mg of sevelamer hydrochloride on serum and urine calcium following an oral load of 5 g of calcium carbonate given with a meal with standardized phosphate content.

Eligibility Criteria:
Inclusion Criteria:

* adult patient
* with eGFR ≤45 ml/min

Exclusion Criteria:

* hypercalcemia (\>ULN),
* serum phosphate \>1.2 times normal value
* calcium-phosphate disturbances not associated with CKD, e.g. Paget disease, osteoporosis, any bone fracture within 6 months before study, multiple myeloma or any neoplastic disease, liver or biliary tract disease, primary hyperparathyroidism
Comparative Study of Osteosynthesis for Chevron Osteotomy of Hallux Valgus Using Degradable Versus Non-degradable Metallic Device

The purpose of the study is to show the equivalence of a new degradable metallic device to a non-degradable metallic device in patients with Hallux Valgus.


Eligibility Criteria:
Inclusion Criteria:

* Female and male patients with an age of 40 to 79 years at the day of surgery
* Symptomatic Hallux Valgus
* Radiological criterium area of proximal joint angle
* Normal motorically functions
* Female patients of childbearing age must be using two reliable contraception methods

Exclusion Criteria:

* Previous bone and/or soft tissue surgeries of the the first metatarsal of the respective foot
* BMI \> 32
* Cysts of the first metatarsal of the respective foot
* Neurological disorders with modified motorically functions
* Clinical evidence of osteoporosis
* Chronic renal impairment
* Known hypersensitivity to components of the implants
* Regular administration of medications containing the metallic elements of the degradable implant
* Pregnant or lactating women
* Current participation in another clinical trial or within 30 days before surgery
Walking Program With Pedometer on Quality of Life in COPD

The aim of this study is to investigate the effects of a walking program on exercise capacity and quality of life in patient with COPD. Method: Patients with COPD were randomly assigned to pedometer group (PG) or control group (CON). Subjects in PG walked to target steps daily with pedometer for 6 weeks. Before and after the program, the following measurements were performed: pulmonary function test (PFT), daily steps, Six-Minute Walk Test (6MWT), COPD Assessment Test (CAT), and quality of life questionnaire (SF-12).

Patients with chronic obstructive pulmonary disease (COPD) are suffered from impaired pulmonary function and dyspnea which result to limited level of physical activity, and impaired quality of life. Exercise and regular physical activity have been proven to break the vicious circle. The aim of this study is to investigate the effects of a walking program on exercise capacity and quality of life in patient with COPD. Method: Patients with COPD were randomly assigned to pedometer group (PG) or control group (CON). Subjects in PG walked to target steps daily with pedometer for 6 weeks. Before and after the program, the pulmonary function was assessed by spiromtery test. The exercise capacity were assessed by six-minute walking test, the physical activity level was assessed by daily steps, The quality of life was assessed by COPD Assessment Test (CAT), and quality of life questionnaire (SF-12).

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Eligibility Criteria:
Inclusion Criteria:

1. diagnosed with COPD
2. in a medically stable condition
3. able to walk unassisted
4. ≥ 40 years of age

Exclusion Criteria:

1. oxygen therapy,
2. hemodynamic instability,
3. signs/symptoms of acute infection
4. severe neurological, musculoskeletal, or cardiovascular conditions that affect walking
Bioequivalence Study of Furosemide 40 mg Tablet in 24 Indonesian Healthy Volunteers

The purpose of this research was to investigate whether Furosemide 40 mg tablet manufactured by PT. Kimia Farma Tbk was bioequivalent to its reference drug and Lasix® 40 mg Tablet manufactured by PT. Aventis Pharma, Indonesia.

Twenty four healty volunteers were given a single dose of Furosemide 40 mg Tablet or Lasix® 40 mg Tablet with 240 mL of water beneath fasting condition. Then the blood samples for Furosemide were drawn and analyzed using UPLC. All subjects sample plasma were analyzed for pharmacokinetic evaluation

Eligibility Criteria:
Inclusion Criteria:

* have read the subject information and signed informed consent documents
* age 18 - 55 years
* body mass index between 18-25 kg/m2
* have a normal electrocardiogram
* blood pressure within normal range (systolic 90-120 mmHg and diastolic 60-80 mmHg)
* heart rate within normal range (60-100 bpm)
* with absence of significant disease or clinically significant abnormal laboratory values on laboratory evaluation, medical history or physical examination during screening
* acceptance to use protection (condom) during intercourse with their spouse throughout the study

Exclusion Criteria:

* those who are pregnant and/or nursing women
* those with a history of hypersensitivity to furosemide, or other diuretics or other ingredients in the drugs or a history of serious allergic reaction to any drug, a significant allergic disease, or allergic reaction
* those with a history or presence of medical condition which might significantly influence the pharmacokinetic of the study drug, e.g. chronic gastrointestinal disease, diarrhea, gastric surgery, renal insufficiency, hepatic dysfunction or cardiovascular disease.
* those with a history or presence of any coagulation disorder or clinically significant hematology abnormalities
* those who are using any medication (prescription or non-prescription drug, food supplement, herbal medicine), particularly the medication known to affect the pharmacokinetic of the study drug, within one week prior to the drug administration day
* those who have participated in any clinical study within 3 months prior to the study (\< 90 days)
* those who have donated or lost 300 ml (or more) of blood within 3 months prior to the study
* those who smoke more than 10 cigarettes a day
* those who are positive to HIV, HBsAg, and HCV tests (to be kept confidential)
* those with a history of drug or alcohol abuse within 12 months prior to screening for this study
* those who are unlikely to comply with the protocol, e.g uncooperative attitude, inability to return for follow up visits, poor venous access
Swept Source OCT Imaging With the DREAM VG-OCT

The Intalight Dream OCT is the first combo anterior plus posterior device to perform both OCT and OCT-A at depth of 16mm. This is especially useful in patient who are very nearsighted as it allows us to image all in one frame. The intention of this study is to see how the images differ on the same patients when compared to the Cirrus OCT and to test for the repeatability of the images on a single day.


Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 18
* Myopes with a current or previously documented spherical equivalent refraction \< -4D
* At least half of the subjects should have had at least one Cirrus OCT RNFL and macula performed as well as a Humphrey visual field performed in those with OCT abnormalities

Exclusion Criteria:

* Unable to comply with study imaging
* unclear ocular media
* Participant has, in the opinion of the investigator, any physical or mental condition that would affect the participation in the study or may interfere with the study procedures, evaluations and outcome assessments.
Irrigation Versus no Irrigation for Cutaneous Abscess

In this study, the investigators are trying to find out if washing out the abscess (pocket of pus) with fluid will help, instead of only taking out the pus. Your care will be the same as usual, except that you will be selected randomly to have your abscess washed out with fluid, or not.

Irrigation of the abscess cavity is commonly described as part of the procedure of incision and drainage of cutaneous abscesses (1-4). Despite this, there are no randomized controlled trials that demonstrate the benefit of irrigation in treatment of these abscesses. Potential disadvantages of irrigation include increased procedural time, pain, increased cost with sterile irrigation solutions and materials to capture the irrigation effluent, and increased risk of microbiologic contamination of the surrounding area. The goal of this study is to examine patients undergoing incision and drainage of cutaneous abscesses to determine if irrigation of the abscess cavity affects the need for further interventions.

Eligibility Criteria:
Inclusion Criteria:

1. All patients 18 years of age and above
2. Patients that require a cutaneous abscess incision and drainage

Exclusion Criteria:

1. Unable to return for 48-hour followup.
2. Patients being admitted to the hospital or going to the operating room for incision and drainage
3. Pregnant patients
4. Prisoners
Preoperative Ultrasound Evaluation of Gastric Contents in Voluntary Termination of Pregnancy During the First Trimester

This is an observational, prospective, monocentric, diagnostic study aiming to evaluate the diagnostic properties of the presence of nausea-vomiting in predicting the existence of gastric contents in preoperative surgical abortion.

Most surgical abortions are performed under general anaesthesia. Inhalation of gastric contents is one of the main complications of general anesthesia, in terms of frequency and severity. Patients in the 1st trimester of pregnancy are frequently subject to nausea and vomiting, even on an empty stomach. The presence of nausea and vomiting prior to surgery means that the anesthetic protocol needs to be modified, as there is a greater risk of complications, particularly allergic ones. Preoperative gastric ultrasound is recognized for its ability to predict the risk of gastric inhalation during anesthesia. It is a non-irradiating, non-invasive, painless and rapid examination. There are no data on the association between gestational nausea and vomiting and the risk of inhalation in the context of preoperative fasting. There are no data on the gastric volume of patients in the 1st trimester of pregnancy with or without nausea. Does gestational nausea and vomiting represent an anesthetic risk of gastric inhalation?

Eligibility Criteria:
Inclusion Criteria:

* Adult patients
* Patients undergoing Voluntary termination of pregnancy by dilatation and aspiration before 14 weeks of amenorrhea

Exclusion Criteria:

* Patient under guardianship or curatorship.
* Patient with language barrier.
* Any condition causing the patient to be considered as having a "full stomach" even before the gastric ultrasound:

  * body mass index (BMI) \> 40 kg/m2
  * Hiatal hernia.
  * History of gastric or esophageal surgery or neoplasia.
  * Gastroparesis (diabetic, hepatocellular insufficiency, severe renal insufficiency, etc.).
* Opposition of the patient to the re-use of her data for the study.
Sequential Tranylcypromine (TC), TC + Dextroamphetamine and TC + Triiodothyronine for Refractory Depression

This pilot study will assess the efficacy of several sequential pharmacological treatments for patients with Refractory Depression.

This pilot study will recruit 40 patients with Major Depression and a history of at least two failed prior adequate somatic treatments. In addition to usual physical work-up, all patients will have extensive thyroid testing, and then will receive standard dose Tranylcypromine (i.e., max. 60 mg/d). Non-remitters will have dose increased to max. 120 mg/d if tolerated. Non-remitters to high dose Tranylcypromine will then have Dextroamphetamine added with frequent blood pressure monitoring to max. 40 mg/d. Non-remitters will have Triiodothyronine added to the Tranylcypromine.

Eligibility Criteria:
Inclusion Criteria:

* Ages between 18-65
* Major Depression
* At least two prior ineffective antidepressant trials (at least 2 different mechanisms) or 1 inadequate ECT trial (at least 8 bilateral treatments)
* Physically healthy

Exclusion Criteria:

* Known Tranylcypromine allergy
* Unable to follow tyramine-free diet
* Known allergy, intolerance or prior addiction to any stimulant would preclude patient's inclusion in the Dextroamphetamine portion of the protocol
* Current substance use disorder including alcohol)(past six months); ever dependent on stimulants would preclude Dextroamphetamine portion of the protocol
* Unable or unwilling to discontinue antidepressants including OTC antidepressants such as St. John's Wort
* History of psychosis, such as schizophrenia or psychotic depression; history of bipolar mania will be allowed if on adequate mood stabilizer
* Suicidal ideation/activity that makes outpatient treatment unsafe, unless protocol can be conducted as inpatient
* Current systolic BP \> 149 or diastolic BP \> 89 mm Hg (two readings); adequately treated hypertension is acceptable
* Evidence of hypo- or hyperthyroidism
* Pregnancy, lactation, refusal to use adequate birth control
Ultra Low Frequency Spinal Cord Stimulation for Chronic Low Back Pain

The Presidio Medical Ultra Low Frequency (ULF™) Spinal Cord Stimulation (SCS) System is intended to provide pain relief to participants who have been clinically diagnosed with chronic low back pain with or without leg pain.

This is a prospective, open-label, multi-center clinical trial in which participants with chronic low back pain (CLBP) with/without leg pain will be invited to enroll and undergo treatment with the ULF SCS system. The purpose of this study is to evaluate the safety and effectiveness of ULF SCS over a 2-year period.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed with chronic low back pain with/without leg pain (VAS ≥60mm for back pain for the past week), which has been refractory to conservative therapy for a minimum of 3 months.
2. Be on no or stable pain medications, as determined by the investigator, for at least 28 days prior to the screening visit.
3. Is currently considered medically stable as judged by investigator.
4. Able to operate the SCS device (e.g., using remote control) and charge the device appropriately.
5. Determined to be a good surgical candidate by the investigator.
6. Willing to sign the Human Research Ethics Committee (HREC) approved informed consent and deemed capable of complying with the requirements of the study protocol.
7. Willing to stay on stable medications until implantable pulse generator (IPG) activation (i.e., from IPG implant to IPG activation, except for usual postoperative medications required following IPG insertion).
8. Able to comply with study requirements and attend all scheduled visits.
9. Eighteen (18) years of age or older.
10. Literate, able to speak English and able to complete questionnaires independently.

Exclusion Criteria:

1. Diagnosis of active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance, intervention and/or ability to evaluate treatment outcome as assessed by a clinical psychologist or psychiatrist in a psychological assessment performed at Baseline.
2. Chronic pain in any area other than back or legs, such that it precludes subject's ability to assess their pain for the primary indication of chronic low back pain as determined by Investigator.
3. Previous experience with implantable neuromodulation devices (e.g., spinal cord stimulation, peripheral nerve stimulation, dorsal root ganglion stimulation).
4. Opioid usage with average total daily morphine equivalent dose (MED) of \>60 mg.
5. A known need for an MRI or surgery within a 2-week period of the screening visit through the end of the study.
6. Female candidates of childbearing potential that are pregnant (confirmed by positive urine/blood pregnancy test) or plan to get pregnant during the duration of the study.
7. Subject is participating in another interventional clinical trial.
RENAL: TNF-alpha Inhibitor for Improving Renal Dysfunction and Primary Graft Dysfunction After Lung Transplant

The purpose of this study is to assess whether TNFa antibody use before lung transplant can prevent kidney injury after lung transplant.

After being informed about the study and potential risks, all patients giving written consent who undergo a lung transplant will be randomized in a 1:1 ratio to either the treatment or control group. Patients randomized to the treatment group will receive one dose of the study drug, Etanercept, via subcutaneous injection just prior to the lung transplant. Patients randomized to the control group will not receive Etanercept. Both groups will receive standard lung transplant care after implantation.

Eligibility Criteria:
Inclusion Criteria:

* Planning to undergo transplantation of the lung at Northwestern Memorial Hospital.
* Willing and able to read, understand, and be capable of giving informed consent.

Exclusion Criteria:

* Previous or current use of TNFa antibody.
* Any condition that, in the opinion of the attending physician, would place the patient at undue risk by participating.
Effects of Inhaled Corticosteroids on Sputum Bacterial Load in COPD

Exacerbations are important events in the natural history of chronic obstructive pulmonary disease (COPD). Beside the acute (and prolonged) clinical impact, there is evidence that exacerbations negatively affect the natural history of the disease; e.g. lung function decline is accelerated in patients with frequent exacerbations. Bacteria are considered the most relevant cause of exacerbations, but there is evidence that viral infections are equally contributing.

Either alone or in combination with viruses, airway bacterial load in stable COPD correlates with both the frequency of exacerbations and the decline in lung function.

A long-term clinical trial recently showed that the regular treatment with inhaled corticosteroids (ICS) increases the risk of infectious events such as pneumonia, whereas it reduces the frequency of acute COPD exacerbations in COPD.

In a recent study it was found that airway bacterial load increases over time (1 yr follow up) in stable COPD. In this study, virtually all patients (93%) were treated with ICS.

This study is designed to evaluate whether long-term (1 year) ICS treatment increases viral and/or bacterial load in the sputum of COPD patients.


Eligibility Criteria:
Inclusion Criteria:

* Sixty stable moderate COPD patients (Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage 2) requiring regular treatment with long-acting bronchodilators, according to international guidelines.
* GOLD stage 2 COPD patients will be enrolled providing they were steroid-free for the last 4 months

Exclusion Criteria:

* Atopy
* Asthma
* Concomitant lung diseases (e.g. lung cancer)
* Acute infections of the respiratory tree in the previous 3 months including COPD exacerbation.
Fibromyalgia and Sexual Functıonal Dısorder and Sexual Therapy

investigators aim to re-evaluate the findings of Fibromyalgia in patients whose FSFI scores return to normal levels after sexual therapy, by identifying patients with sexual dysfunction according to the FSFI scale applied in patients investigators followed up with a diagnosis of fibromyalgia, and when investigators consulted with obstetricians.

Apart from routine Fibromyalgia treatments, investigators think that Fibromyalgia patients should be evaluated in detail in terms of sexual dysfunction, and better results will be obtained by adding sexual therapy to the treatment in patients with FSFI score below 26.55.

In the current literature review, investigators have seen that there is no study on the evaluation of fibromyalgia before and after sexual therapy.

investigators think that our study will be a pioneer in terms of showing the importance of the multidisciplinary approach in the treatment of Fibromyalgia.

investigators foresee that sexuality is still a subject that is avoided to be talked about due to the cultural infrastructure of developing countries, and that Fibromyalgia will actually decrease with the regulation of sexual life.

investigators believe that more comprehensive studies with this perspective will develop a multidisciplinary approach in Fibromyalgia.

Eligibility Criteria:
Inclusion Criteria:

* Follow-up with a diagnosis of fibromyalgia
* Reproductive age (15-49 years)
* Women with sexual dysfunction (FSFI score \< 26.55)

Exclusion Criteria:

* Women Wıth Ibromyalgıa Wıthout Sexual Dysfunction
* Women Wıth A Score Greater 26.55 Wıthout Therapy
A Cohort for Evaluation of Open-label PrEP Use and PreP Preferences Among African Women

INSIGHT is a Prospective, Observational, open-label cohort study on women in Sub-Saharan Africa on PrEP screening, informed choice, and compliance.

There are no specific intervention arms or comparative treatment plans. We will follow and observe participants taking PrEP, not taking PrEP, as well as those who begin or end PrEP during the course of the observational period.

Primary goals:

* Estimate HIV incidence using recency testing on samples from women who screen out due to HIV infection, as well as assess HIV incidence prospectively in the cohort.
* Assess the characteristics of women who initiate PrEP compared to those who do not initiate PrEP.
* Evaluate young women's preferences for attributes of long-acting formulations of PrEP, using a discrete choice experiment.
* Assess the acceptability of a patient-facing PrEP decision support tool to provide young women more informed choice about PrEP options.

Eligibility Criteria:
Inclusion Criteria:

* 16-30 years of age
* Female

Exclusion Criteria:

* not sexually active
* over 31 years of age at consent