cyrilzakka/clinical-trials huggingface dataset:
Study of Genotype and Phenotype Expression in Congenital Nephrogenic Diabetes Insipidus

OBJECTIVES:

I. Determine the relationship between genotype variations and clinical phenotype in patients with congenital nephrogenic diabetes insipidus.

PROTOCOL OUTLINE: A detailed family history is obtained from all participants. Whenever possible, standard growth curves of affected children are obtained.

Participants then undergo clinical studies of antidiuretic function. A standard fluid deprivation-vasopressin challenge is performed with timed measurements of osmolality, electrolytes, creatinine, and vasopressin. The next day, blood pressure, plasma cyclic AMP, GMP, von Willebrand Factor, Factor VIII, and urine osmolality are measured during a water load desamino-D-arginine vasopressin (dDAVP) infusion test.

Participants with a confirmed diagnosis of congenital diabetes insipidus are then treated with chlorothiazide. Daily urine volume and osmolality are determined before and after therapy. Sodium and fluid are not restricted.

For each family, the entire vasopressin V2 gene of at least 1 affected male, and where possible at least 1 obligate carrier and 1 unaffected brother of a patient is sequenced. In addition, a detailed Xq28 haplotype analysis is done to identify the origin of de novo mutations. If no mutation is found and the disorder is not transmitted in an X-linked mode, both alleles of the gene that codes for aquaporin-II are also sequenced. DNA is collected by mail from as many kindred as possible who do not participate in the clinical studies.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

* Known or suspected congenital nephrogenic diabetes insipidus
* Clinically and genetically unaffected relatives entered as controls

--Patient Characteristics--

* Age: 6 months to 70 years
Assessment of Near Vision Capacity in Different Light Conditions Following Bilateral Trifocal Intraocular Implantation

Patients who underwent presbyopic correction with bilateral trifocal intraocular lenses implantation are supposed to have sufficient uncorrected vision capacity for activities of daily living (ADLs) that require near vision acuity (NV), (ie. book reading). However, it is known that light intensity and temperature has a great impact on near vision capacity. Primary objective of this study is to identify the optimal task lighting conditions (in terms of light intensity and temperature) for ADLs that demand near vision acuity for a sample of patients who underwent presbyopic correction with bilateral trifocal intraocular lenses implantation

Patients who underwent presbyopic correction with bilateral trifocal intraocular lenses implantation are supposed to have sufficient uncorrected vision capacity for activities of daily living (ADLs) that require near vision acuity (NV), (ie. book reading). However, it is known that light intensity and temperature has a great impact on near vision capacity. Primary objective of this study is to identify the optimal task lighting conditions (in terms of light intensity and temperature) for ADLs that demand near vision acuity for a sample of patients who underwent presbyopic correction with bilateral trifocal intraocular lenses implantation. The following light intensities will be evaluated: 25, 50, and 75 foot candles. Moreover, the following light temperatures will be evaluated: 3000, 4000, and 6000 Kelvins.

Eligibility Criteria:
Inclusion Criteria:

Presbyopia

Exclusion Criteria:

Glaucoma Corneal pathology Fundus pathology Severe neurological/mental diseases that interfere with visual acuity
Mineralocorticoid Receptor and Obesity Induced Cardiovascular Complications

The purpose of this study is to find out if spironolactone, a drug that blocks the action of aldosterone, can make the blood vessels work better in people with obesity. The investigators also want to find out whether spironolactone causes changes in levels of insulin and markers of inflammation.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18-70 years
2. Good health as evidenced by history and physical exam
3. Body Mass Index (BMI): \>30 kg/m2 and \<45 kg/m2

Exclusion criteria:

1. Medical illnesses other than treated hypothyroidism
2. Blood Pressure (BP) \>135/85 or systolic BP \<90 mm Hg
3. Hepatic disease (transaminase \> 3 times normal)
4. Renal impairment (Creatinine clearance \<60 ml/min)
5. Baseline serum Potassium (K) \>5.0 mmol/L
6. History of drug or alcohol abuse
7. Allergies to spironolactone
8. Participation in any other concurrent clinical trial
9. Women using oral contraceptives within the last 3 months
PHArmacotherapy Assessed Using Neuroprobing With TransOsseal Magnetic Stimulation

The goal of this observational study is to investigate how prescribed anti-seizure medications (ASMs) affect cortical excitability in adults with epilepsy. The main questions it aims to answer are:

1. Does the magnitude of transcranial magnetic stimulation (TMS)-evoked potentials (TEPs) measured with electroencephalography (EEG) change between OFF and ON medication states?
2. Do these changes in TEP amplitude persist over time? Researchers will compare each participant's measurements in the OFF state with those in the ON state to see if TEPs change following ASM (re)start.

Participants will undergo one TMS-EEG session scheduled around their prescribed ASM (re)start and one 1-6 months later.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (≥ 18j) with epilepsy receiving a prescription for an anti-seizure medication for clinical reasons
* Written informed consent

Exclusion Criteria:

* Presence of any electrical implants (e.g. neurostimulator or drug delivery system) or any metallic implants anywhere in the head (excluding teeth)
* Increased intracranial pressure
* Uncontrolled psychiatric disorder
* Use of any kind of drug or alcohol, nicotine allowed
* For female participants: If pregnancy cannot be ruled out with sufficient certainty, a pregnancy test (urine) will be carried out before using TMS
* Inability to give consent
TeSE (Testicular Sperm Extraction) in Azoospermic Patients: m-TeSE vs. l-TeSE

The aim of the study is to compare surgical outcomes (intra and post-operative complications) and sperm retrieval rates between conventional microsurgical-assisted testicular sperm extraction (m-TeSE - Group A) and testicular sperm extraction performed with surgical loupes (l-TeSE - Group B) in adult males with non-obstructive azoospermia.

Objective: To compare surgical outcomes and sperm retrieval rates (SRR) between conventional microsurgical-assisted testicular sperm extraction (m-TeSE - Group A) and testicular sperm extraction performed with surgical loupes (l-TeSE - Group B) in adult males with non-obstructive azoospermia (NOA). A multicentric prospective randomized trial was conducted from March 2022. Adult males with NOA without genetic alterations who agreed to participate in the study and signed the required informed consent were enrolled. SRR, intra and post-operative complications (according to Clavien-Dindo classification), hormonal profile tchanges were considered as outcomes during the follow up period.

Eligibility Criteria:
Inclusion Criteria:

* Adult males
* Diagnosis of non obstructive azoospermia who required m-TeSE.

Exclusion Criteria:

* Absence of signed written informed consent
* Age \< 18 years
* Obstructive azoospermia
* Genetic anomalies (e.g., Klinefelter syndrome, Kallmann syndrome, Y chromosome microdeletions, CFTR mutations)
* Previous testicular biopsies/surgical sperm retrieval
* Personal history of malignant testicular tumor
* Unilateral cryptorchidism
* Varicocele
* Previous chemotherapy/radiotherapy treatments
* Monorchidism
A Study of Canagliflozin and Metformin Immediate Release (50 mg/500 mg) FDC Tablets in Healthy Volunteers

The purpose of this study is to evaluate the bioequivalence of fixed dose combination (FDC) tablets of canagliflozin and metformin immediate release (IR) in comparison with the individual components of the FDC tablets (canagliflozin and metformin IR).

This is an open-label (identity of study drug will be known to volunteer and study staff), single-center study to evaluate the bioequivalence (to see if blood levels of one drug are equivalent to blood levels of another drug) of canagliflozin and metformin IR when administered orally (by mouth) as individual components (ie, separate tablets of canagliflozin and metformin IR) (Treatment A) and when administered as FDC tablets (ie, canagliflozin and metformin IR contained in the same tablet) (Treatment B). Healthy volunteers participating in the study will be randomly (by chance) assigned to receive a single dose of Treatment A followed by a single dose of Treatment B or Treatment B followed by Treatment A with a washout period of approximately 15 days between treatments. The total duration of the study will be approximately 51 days.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) between 18.5 and 30 kg/m² (inclusive) and a body weight of not less than 50 kg

Exclusion Criteria:

* History of or current medical illness, abnormal values for hematology or clinical chemistry laboratory tests, or abnormal physical examination, vital signs or 12-lead ECG deemed to be clinically significant by the Investigator
A 52 Week Open Label Trial of Memantine for Frontotemporal Lobar Degeneration

This is a 52-week, multicenter, open label trial of memantine (Namenda) for frontotemporal lobar degeneration (FTLD). The goal is to determine the safety and tolerability of this FDA-approved medication for Alzheimer's Disease in patients with FTLD. Secondary outcome measures include cognitive batteries, rating scales for activities of daily living and neuropsychiatric symptoms. All patients receive the FDA-approved dose of this medication for Alzheimer's disease.


Eligibility Criteria:
Inclusion Criteria:

* Neary et al. Criteria for Frontotemporal Lobar Degeneration
* Age 40 -80
* CDR \< 3 or MMSE \> 15
* English Speaking
* Study Partner

Exclusion Criteria:

* Concurrent use of antipsychotic drugs or acetylcholinesterase inhibitors
Clinical Evaluation of Color Stability of Direct Composite Resin Veneers in Vital Anterior Teeth

Assess color stability of direct veneers over an 18-month recall periods

In today's restorative dentistry, aesthetics has become essential. The primary determinants of the aesthetics of natural teeth are color and form. The significance of color in dental science has greatly increased during the past few decades.

Techniques to restore teeth to their natural appearance have been developed in direct response to patient demand for cosmetic dental procedures. In contemporary cosmetic dentistry, discolorations are often seen as an aesthetic concern.

In order to correct cosmetic flaws in color and form, direct laminate veneers entail the creative application of resin composite material to the tooth surfaces. Because they may be completed chairside, are readily repaired, and have abrasion rates that are similar to those of real teeth, they are viewed as competitors to ceramic veneers.

With direct resin composite veneers, color stability is thought to be a common clinical issue that reduces the aesthetic result over an extended period of clinical service. The capacity of any dental material to retain its original color is known as color stability.

The clinical restoration process is streamlined with the introduction of universal composites, which also considerably reduce chair-side time and simplify the color matching such as OMNICHROMA.

Eligibility Criteria:
Inclusion Criteria:

* have good hygiene.
* No medical diseases
* discolored vital anterior teeth

Exclusion Criteria:

* para functional activities.
* non vital teeth.
* severe intrinsic discoloration.
Reduction of Intravenous Antibiotics In Neonates

Randomized controlled open-label non-inferiority trial comparing complete intravenous antibiotic treatment with a short iv. course followed by oral antibiotics in neonates (0-28 days) with probable bacterial infection.

Primary outcome:

- Bacterial re-infection within 28 days after finishing of antibacterial therapy.

Secondary outcome(s):

* Pharmacokinetic profile of oral amoxicillin/clavulanic acid
* Quality of life
* Cost-effectiveness
* Alterations in gut microbiome
* Use of molecular techniques for better detection of bacterial pathogens

Neonates have a high antibiotic consumption because of their susceptibility for bacterial infections. Since the early diagnosis of bacterial infection in neonates is difficult, intravenous broad-spectrum antimicrobial therapy is usually started promptly after subtle symptoms. The majority of neonates become asymptomatic shortly after initiation; when infection is probable or proven by elevated inflammatory markers and/or a positive blood culture, intravenous antibiotics are administered for at least 7 days.

However, for neonates blood culture has a limited sensitivity. Therefore, the majority of neonates with probable infection are treated for a prolonged time with intravenous broad-spectrum antimicrobial therapy. In older children, intravenous antibiotics are often changed to oral antibiotics after cessation of symptoms and decreasing inflammatory parameters. This is not yet widely practised in neonates because of uncertainties in pharmacokinetics. Two explorative small studies from France and Italy into neonatal antibiotic switch therapy suggest that follow-up treatment with an oral antibiotic is promising; but the non-inferiority and safety was not yet properly addressed. Neonatal switch therapy, if proven to be safe and efficacious, would have a major impact on neonatal well-being, mother-to-child bonding and moreover costs.

Eligibility Criteria:
Inclusion Criteria:

* Neonates (≥ 35+0 weeks, 0-28 days old, ≥ 2 kg)
* Probable bacterial infection defined as clinical symptoms and/or maternal risk factors and elevated inflammatory markers for which empiric broad-spectrum antibiotic treatment was initiated and needs to be continued for \> 48 hours
* Clinically well
* Toleration of oral feeding without overt vomiting
* Signed informed consent

Exclusion Criteria:

* Proven bloodstream infection
* Absence of blood culture
* Severe localized infection (meningitis, osteomyelitis, necrotizing enterocolitis)
* Severe clinical sepsis (compromised circulation, need for mechanical ventilation)
* Continuous need for a central venous line
* Severe hyperbilirubinemia exceeding the exchange level
* Parents inability to administer medication
* Major congenital or syndromic anomalies
Brief Intervention for Teen Pregnancy Prevention

Although the Academy of Pediatrics and the Society for Adolescent Health and Medicine recommend that teen health providers screen for sexual risk behaviors and provide education and counseling to those at risk, there are currently no specific guidelines or protocols available to guide such practices, nor have there been any rigorous evaluations of efficacy. Preventing teen pregnancy through brief intervention in primary care holds the promise to have a significant public health impact and reduce health disparities by engaging, educating, and motivating the majority of teens who visit a primary care setting each year. In the current study, we seek to rigorously evaluate the impact of brief intervention vs. informational control on unprotected sexual intercourse among teens with past year unprotected sex at two primary care clinics serving predominately underserved, minority populations in New Mexico. The target population for the current study will be 1350 male and female teens, aged 13-19, from the Atrisco Center for Family and Community Health and the Albuquerque Job Corps Wellness Center. Extensive formative work involving the study population will be conducted prior to the trial to refine the motivational interviewing-based brief intervention. Eligible youth will be randomly assigned to brief intervention or an informational control condition, in addition to regularly offered medically-based contraception consultation and prescription services. Follow-ups at 3- and 9- months will compare rates of unprotected sex and acceptance of long-acting reversible contraceptives. Brief education and counseling interventions could be feasibly implemented during the greater than eight preventive and acute primary care visits that the average US adolescent attends during their teen years. Such an approach could conserve valuable resources required by more intensive interventions for nonresponsive teens with greater need. Furthermore, social determinants of health, such as poverty and race, that may reduce access to more extensive psychosocial interventions, are less likely to prevent access to primary care, increasing health equity.


Eligibility Criteria:
Inclusion Criteria:

* Aged 13-19
* Self-reported past year unprotected sex
* Can read and speak English
* Willing to be contacted for follow-up

Exclusion Criteria:

* Current use of long-acting reversible contraceptives
* Self-reported pregnancy or pregnancy discovered during optional medical contraception consultation
* Expressed suicidality
* Obvious cognitive impairment
* Inability to provide informed consent
Model 4968 CAPTURE EPI® STERIOD-ELUTING BIPOLAR EPICARDIAL PACING LEAD Post-approval Study

The Medtronic CapSure Epi Lead Post-approval Study will assess long-term safety of the 4968 lead. This study is part of the Medtronic System Longevity Study.

The Medtronic CapSure Epi Lead Post-approval Study is being conducted as part of the requirements to satisfy the PMA conditions of approval for the Model 4968 lead. 100 subjects (adult and pediatric) with a 4968 lead will be followed for a minimum of five years to assess the long-term safety of the leads.

Eligibility Criteria:
Inclusion Criteria:

* Provision of written informed consent and/or authorization for access to and use of health information by subjects or appropriate legal guardians as required by an institution's Investigational Review Board, Medical Ethics Board, or Research Ethics Board
* Availability of implant, follow-up, and product-related event data
* Implanted with a Model 4968 Capsure Epi Lead

Exclusion Criteria:

* Subjects receiving an implant of a Medtronic lead at a non-participating center and the implant data and current status cannot be confirmed within 30 days after implant
* Subjects who are, or will be inaccessible for follow-up at a 4968 Post-approval study center
* Subjects implanted with a Medtronic cardiac therapy device whose predetermined enrollment limit for that specific product has been exceeded
* Subjects with exclusion criteria required by local law
Investigation of the Effect of Pilates Exercises on Patellofemoral Pain

This study aimed to investigate the effectiveness of Pilates exercises in Patellofemoral pain patients compared to hip and knee combined exercises in improving pain, muscle strength, flexibility, function and quality of life in short term.

Patellofemoral pain is a common condition characterized by pain in anterior knee, around the kneecap. It is known that exercise is beneficial in rehabilitation in general. Exercise programs applied to patients with PFP should include hip and knee-targeted combined exercises. Nowadays, Pilates is used as an effective rehabilitation tool for individuals with musculoskeletal problems, especially in reducing pain and improving function. Therefore, we believe that Pilates exercises can be effective in PFP Considering that PFP is a chronic condition and exercise therapy is one of the main strategies in the treatment. Pilates may be preferred as one of the alternative treatment method.

This randomized controlled study was designed to compare the effects of two different treatment protocols, Group-I (Supervised Rehabilitation) and Group-II (Pilates Exercises). Patients who applied to the Istanbul Physical Therapy and Rehabilitation Training and Research Hospital, Sports Medicine outpatient clinic and were diagnosed with PFP by a specialist physician based on the patient histories, physical examinations, and diagnostic imaging. The estimated desired sample size was at least 14 participants per group. We anticipated a dropout rate of 20%. Therefore, 34 participants were required for each group (Supervised Rehabilitation n=17, Pilates Exercises n=17) of both sexes, ages ranging from 18-45 years. A computer generated randomization list was used to divide the patients into two groups (https://www.randomizer.org/). An 'Informed Consent Form' was obtained from patients by explaining the purpose of the study, the duration of the study, the treatments to be applied, and possible side effects.

Eligibility Criteria:
Inclusion Criteria:

* Having characteristic signs of PFP (retropatellar or peripatellar pain)
* Presence of at least 3 points of retropatellar or peripatellar pain on the Numbered Pain Rating Scale (NPRS) with squatting, climbing stairs, prolonged sitting, or functional activity that burdens the PFP
* Presence of any of the criteria such as tenderness, small effusion in the patellar facet palpation

Exclusion Criteria:

* Patellofemoral dislocation, subluxation, intra-articular knee pathology
* Previous lower extremity surgery, and knee-related trauma
* A history of hip pathology or neurological disorders
* Knee trauma in the last 1 month
Hyaluronic Acid +Hydroxyapatite Vs Hydroxyapatite in Bone Regeneration

Evaluation of the effect of hyaluronic acid with hydroxyapatite versus hydroxyapatite alone on bone regeneration following enucleation of mandibular odontogenic cyst.

During cyst enucleation , There's resultant decrease in bone density especially in large defects .Therefore, it may be needed for a bone grafts and bone regenerative materials to improve quality of bone .The rationale is to evaluate hyaluronic acid with hydroxyapatite as a bone quality improvement material following cyst enucleation, which would provide significant bone regeneration. Hydroxyapatite is inorganic component of bone tissue used as bone graft, scaffolds, filler and cement for repair and regeneration of bone defect , and it is stimulate bone remodeling by generating surface active moieties or cell signaling process while Hyaluronic acid and it's derivatives has been widely used for bone regeneration and it has a good potential for osteogenesis and mineralization

Eligibility Criteria:
Inclusion Criteria:

* Patient in need of cyst removal .
* Both genders aged between 18-50 years .
* Size of lesion is ≤ 4 cm .
* Patients free from any systemic disease that may affect bone healing .

Exclusion criteria :

* Heavy smokers , alcohol intake .
* Poor oral hygiene .
* Patient with systemic disease that may affect bone healing .
* Pregnant women.
* Patient who are currently or have been under treatment using chemotherapy or radiotherapy
* Uncooperative patient .