cyrilzakka/clinical-trials huggingface dataset:
Effects of Teriparatide in Postmenopausal Women With Osteoporosis

Effects of Teriparatide in Postmenopausal Women Previously Treated with Alendronate or Raloxifene.


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women aged at least 50 years
* A previous clinical diagnosis of osteoporosis
* At high risk for fracture
* Current therapy for at least 18 months prior to study entry with either raloxifene HCl or alendronate Na

Exclusion Criteria:

* History of metabolic bone disease other than osteoporosis
* History of malignant neoplasm within the last 5 years except for superficial basal cell carcinoma or squamous cell carcinoma
A Study to Evaluate the Effectiveness and Safety of an Implant in the Treatment of Osteoarthritis of the Great Toe

This study will evaluate whether Cartiva is an effective treatment for individuals with osteoarthritis of the great toe.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years of age
* Osteoarthritis of the first metatarsophalangeal joint and is a candidate for arthrodesis
* Presence of good bone stock
* Capable of completing self-administered questionnaires

Exclusion Criteria:

* \< 18 years of age
* Osteoarthritis of the first metatarsophalangeal joint, though is not a candidate for arthrodesis
* Active bacterial infection of the foot
* Additional ipsilateral limb (hip, knee, ankle, or foot) pathology that requires active treatment (surgery or brace)
Clinical Utility Assay as a Biomarker for Gastroenteropancreatic and Lung Neuroendocrine Tumors

The purpose of this study is to evaluate how well an investigational blood test performs. The study will look at the sensitivity and specificity of a blood-based multitranscriptome assay (NETest).


Eligibility Criteria:
Inclusion Criteria:

NET Cohort-

* Patients with histologically or cytologically proven diagnosis of any grade, any stage NET of GEP or lung origin; In the first stage of the study (initial 50 patients) only patients with stage IV, well-differentiated tumors (G1/G2) will be enrolled.
* Patients with stable or progressive disease, as documented on a scan (CT, MRI); Progression status will be documented on case report form (CRF).
* Allowed prior therapies include: a.) Surgery (tumor surgery at least four weeks prior to study entry); b.) Locoregional therapy such as: chemoembolization, radio-embolization, radiofrequency ablation, radiotherapy at least six weeks prior to study entry; c.) Any number of previous lines of systemic therapy, providing that cytotoxic therapies (chemotherapy, PRRT) have been discontinued at least 4 weeks prior to study entry.

Non-NET Cohort -

* Healthy participants
* Patients with histologically or cytologically proven diagnosis of any grade, any stage GI malignancies.

Exclusion Criteria:

NET Cohort -

* Patients on treatment with cytotoxic agents (chemotherapy, PRRT).
* Patients with renal insufficiency or congestive heart failure.
* No other active malignancy within 3 years of enrolment except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission.

Non-NET Cohort

* Patients with GI malignancies with neuroendocrine differentiation.
The PSVT Place Registry.Paroxysmal Supraventricular Tachycardia (PSVT) Registry.

Paroxysmal supraventricular tachycardia (PSVT) is a sporadic, sudden, and recurring tachycardia that is caused by an altered electrical conductivity in the heart. It causes palpitations and a rapid heart rate, which may induce fear in the patient and negatively impact the patient's quality of life. Therefore, most patients experience not only physical symptoms of PSVT, but also dramatic psychological burdens.

As PSVT drug development efforts advance, it has become increasingly important to document the impact of PSVT in a systematic way, in terms of the disease natural history and clinical characteristics of PSVT episodes, as well as the psychological impact of the condition as reported by patients over time. In order to meet the needs for ongoing, systematic data collection on PSVT, a multinational registry, The PSVT Place Registry (www.PSVTPlaceRegistry.com), is being implemented and will be initially comprised of data entered directly by patients. The long-term registry is designed with a participant-focused approach to enable continuity of data collection and minimization of impact from changes of participants' health care providers. The registry may be expanded at a later time to include physician-reported data.

The information from the registry is planned to be a resource for participants with PSVT, their families and support networks, their doctors, and the research community to better understand PSVT-related symptoms and awareness, PSVT diagnoses, patient self-management, medical treatments for PSVT, and impact of PSVT on quality of life from the patient perspective.


Eligibility Criteria:
Inclusion Criteria:

A participant must meet all of the following criteria to be eligible for participation in the study:

* Adult male or female.
* Participant has suspected PSVT as per the online prescreening assessment.
* Participant lives in a country in which the registry is being conducted.
* Participant has signed the informed consent form indicating he/she is able to complete the online registry data collection forms on his/her own.

Exclusion Criteria:

* Participant does not have an email address.
* Participant does not set up a user account.
Continuous Positive Airway Pressure and Cardiometabolic Risk

The hypothesis for this study is that children with sleep disordered breathing will benefit from treatment with Continuous Positive Airway Pressure (CPAP) or Bi-level Positive Airway Pressure (BiPAP) in terms of reduction in cardiovascular risk markers and insulin resistance.

The CPAP machine delivers a predetermined level of pressure. It releases a stream of compressed air through a hose to the nose mask and keeps the upper airway open under continuous air pressure. This air pressure prevents obstructive sleep apnea, which occurs as a result of narrowing of the airway due to the relaxation of upper respiratory tract muscles during sleep. This machine helps to increase the oxygen flow by keeping the airway open.

The BiPAP machine delivers two levels of pressure. Inspiratory Positive Airway Pressure (IPAP) is a high amount of pressure, applied when the patient inhales and a low Expiratory Positive Airway Pressure (EPAP) during exhalation.

Obese children with Moderate to Severe Sleep Apnea will have baseline evaluation of markers of cardiometabolic risk and insulin resistance. Subjects will then use either the CPAP or BiPAP machine for 3 months and will return for another blood draw for measurement of the markers for cardiometabolic risk and insulin resistance.

Eligibility Criteria:
Inclusion Criteria:

1. Body mass index greater than 95th percentile for age and gender
2. Moderate to severe obstructive sleep apnea (OSA) (as defined by an apnea-hypopnea index (AHI) score of ≥5 events per hour).

Only patients who provide informed assent or consent and also have consent from a parent will be included.

Exclusion Criteria:

1. Predominant central sleep apnea
2. Type 1 Diabetes
3. Type 2 Diabetes
4. Requires use of supplemental oxygen
5. Active infection, cancer, or chronic inflammatory disorder
6. Use of systemic steroids
7. Simultaneous use of peroxisome proliferator-activated receptor (PPAR)-alpha (e.g., gemfibrozil, fenofibrate) or PPAR-gamma (e.g., rosiglitazone, pioglitazone)
Safety/Efficacy Study of Subcutaneously Injected Prandial Insulins Compared to Insulin Lispro Alone in Patients With Type 2 Diabetes Mellitus

The purpose of the study was to compare Humalog (insulin lispro)-recombinant human hyaluronidase PH20 (rHuPH20) or Novolog (insulin aspart)-rHuPH20 to insulin lispro for the treatment of Type 2 diabetes mellitus (T2DM) in basal-bolus therapy.

Criteria for randomization into the study included 1) fasting blood glucose and pre-dinner glucose values in the range of 70 to 140 milligrams per deciliter (mg/dL) approximately 60% of the time for 7 days prior to randomization; 2) 90 minute or 2-hour postprandial blood glucose \<220 mg/dL approximately 70% of the time for 7 days prior to randomization; and 3) successfully completing 3 days of 10-point glucose monitoring and have at least 4 self-monitored blood glucose values on all non-10-point monitoring days. Participants that did not meet 1 or more of these criteria during a 4- to 6-week Titration Period were not randomized.

Eligibility Criteria:
Inclusion Criteria:

* Males or females ≥18 years
* Type 2 diabetes mellitus (T2DM) treated with insulin ≥12 months and prandial insulin (at least 2 meals per day) for ≥2 months
* Body mass index (BMI) of 23.0 to 45.0 kilograms per meter squared (kg/m\^2)
* Glycosylated hemoglobin (HbA1C) level 7.0 to 8.5%, inclusive
* Fasting C-peptide \<0.6 nanograms per milliliter (ng/mL)
* Willingness to use insulin glargine twice a day as basal insulin for the duration of the study
* Willingness to avoid use of an insulin infusion pump or unblinded continuous glucose monitoring (CGM) during the study

Exclusion Criteria:

* Known or suspected allergy to any component of any of the study drugs
* Exclusive use of pre-mixed insulins
* Use of pramlintide, exenatide, and/or liraglutide within 30 days of screening
* Use of sulfonylureas within two months of screening
* Use of drugs (such as corticosteroids or antimetabolites) that could interfere with the interpretation of study results or are known to cause clinically relevant interference with insulin action, glucose utilization, or recovery from hypoglycemia, during the study or within 30 days of screening
* Recurrent severe hypoglycemia (more than 2 episodes over the last 6 months) or hypoglycemic unawareness, as judged by the investigator
Effect of Tourniquet Application on Optic Nerve Sheath Diameter

The aim of the study to investigate the effect of tourniquet application on optic nerve sheath diameter (ONSD) and cerebral oxygenation during lower extremity surgery.


Eligibility Criteria:
Inclusion Criteria:

* ASA I-II risk group over the age of 18
* Operation planned under general anesthesia
* Lower extremity surgery with a tourniquet
* Agreeing to volunteer for research with an informed consent form

Exclusion Criteria:

* Emergency surgical procedures
* neurological disease, carotid disease
* Previous intracranial or ocular surgery
* Neurological symptoms
* cerebral edema, high IntraCranial Pressure
* Presence of glaucoma
* Body mass index (BMI)\> 35
* Uncontrolled hypertension
* Diabetic retinopathy
* anemia
* coronary artery disease
* peripheral artery disease
T-20 With Anti-HIV Combination Therapy for Patients With Prior Anti-HIV Drug Treatment and/or Drug Resistance to Each of the Three Classes of Approved Anti-HIV Drugs

The purpose of this study is to compare the change in viral load (amount of HIV in the blood) of patients who receive T-20 with selected anti-HIV drugs to that of patients who receive only selected anti-HIV drugs.

Eligible patients remain on their pre-study regimen until baseline. An OB regimen is chosen by the physician and patient based on the patient's prior treatment history, prior and current laboratory abnormalities, the screening GT/PT antiretroviral resistance testing, and any prior GT/PT antiretroviral resistance (if available). The drugs in the OB regimen are chosen from among the currently approved antiretrovirals and permitted newly approved/investigational antiretrovirals available in the countries where the study is implemented, and must consist of 3 to 5 drugs, including no more than 1 newly approved/investigational agent. Patients are stratified with respect to viral load and use (versus non-use) of any of the allowed newly approved/investigational antiretrovirals. Patients are randomized to receive 1 of the following 2 treatments for 48 weeks: OB or OB plus T-20. Patients are followed to assess viral load, safety, antiretroviral resistance, T-20 pharmacokinetics, and quality of life. At the end of 48 weeks of treatment patients are allowed to (a) roll over and receive OB plus T-20 (for patients receiving OB regimen alone) or (b) continue taking OB plus T-20 (for patients already receiving OB plus T-20), for an additional 48 weeks (plus 4 weeks safety follow-up period), or until 12 weeks after commercial availability of T-20 in the country in which they are treated, whichever comes first. All patients are followed in this study for a maximum of 100 weeks from their initial baseline visit date.

Eligibility Criteria:
Inclusion Criteria

Patients may be eligible for this study if they:

* Are HIV-infected.
* Are at least 16 years old (have consent of parent or guardian if under 18).
* Have a viral load (level of HIV in the blood) of 5,000 copies/ml or more.
* Have received anti-HIV drugs for at least 6 months and/or have shown resistance to each of the 3 types of anti-HIV drugs as follows: nucleoside reverse transcriptase inhibitors (resistant to 1 or more); nonnucleoside reverse transcriptase inhibitors (resistant to 1 or more); and protease inhibitors (resistant to 2 or more, taken either together or 1 after the other for at least 6 months total).
External Cephalic Version Immediately Before a Caesarean Delivery

Fetal malpresentation at term affects around 5% of pregnancy and breech presentation is the most common type of malpresentation. It is a common indication for a Caesarean delivery. External cephalic version (ECV) refers to turning the fetus manually and aims to increase the success of vaginal birth by reducing the need for Caesarean section.

Several factors affect the chance of a successful ECV which include multiparity, use of tocolytic and regional anaesthesia during the procedure. Anticipating or not tolerating a painful procedure is another factor that affects the willingness to and success of ECV.

ECV can be reattempted under regional anaesthesia immediately just before the Caesarean section to increase the vaginal birth rate in women who have failed an ECV. Therefore, the aim of this study is to evaluate whether this approach could increase the rate of vaginal birth and reduce the non-cephalic presentation at labour and Caesarean section rate.

Eligibility Criteria:
Inclusion Criteria:

* All women age ≥ 18 years old
* Singleton pregnancy
* Malpresentation
* Have failed an ECV
* Pregnant ≥ 37 weeks of gestation

Exclusion Criteria:

* Condition requiring emergency delivery
* Other indication for Caesarean section
* History of antepartum haemorrhage in the past 7 days
* Oligohydraminos with amniotic fluid index \<5cm
* Intrauterine growth restriction with abnormal fetal Doppler or cardiotocography
* Rhesus isoimmunization
* Rupture of membranes
* Gross fetal anomaly
* Major uterine anomaly
* Contraindication or refusal to regional anaesthesia
* Spontaneous cephalic version on the day of scheduled Caesarean section
Study of Reduced Anti-coagulation/Anti-platelet Therapy in Patients With the HeartMate II Left Ventricular Assist System (LVAS) (TRACE)

The purpose of this observational study is to obtain multi-center data on HeartMate II (HMII) patients managed with reduced anticoagulation or anti-platelet regimes, and the incidence of thrombotic and bleeding adverse events associated with these regimes.


Eligibility Criteria:
Inclusion Criteria:

* HeartMate II Left Ventricular Assist Device (LVAD) patient
* Patient has signed an informed consent for data collection.
* Patient was discharged, or is being discharged, from the hospital after their initial LVAD implant surgery.
* Patient:

  * at time of enrolling in study, is currently on, with the intention of being maintained on reduced anti-thrombotic therapy (RT) for chronic long-term management.

OR

-- On or after January 1, 2011 patient was being maintained on, or had been initiated with the intention of being maintained on, reduced anti-thrombotic therapy (RT) for chronic long-term management; but where RT was subsequently discontinued due to an adverse event or transplant, explant, or death.

Exclusion Criteria:

* Patients under acute management of anti-thrombotic agents before a final decision on long term antithrombotic strategy.
* Patients requiring a legal representative to sign consent form, rather than themselves.
* Patient is being managed on other anti-thrombotic agents
School Screening and Telemedicine Specialty Referral to Address Childhood Hearing Loss in Rural Alaska

The prevalence of childhood hearing loss in rural Alaska is disproportionately high and predominately infection-related. With preventive screenings and access to health care, much of childhood hearing loss is preventable. Although state-mandated school screening helps identify children with hearing loss, loss to follow-up is pervasive and exacerbated by a scarcity of specialists in rural regions. A mixed methods cluster randomized trial conducted in northwest Alaska demonstrated that telemedicine can significantly reduce loss to follow-up. This stepped wedge trial, in partnership with Southcentral Foundation, will build on this existing work to develop a model that can be scaled in diverse environments.

We will adapt and implement a new telemedicine intervention called Specialty Telemedicine Access for Referrals (STAR). This trial will be conducted in 3 regions in rural Alaska that represent multiple healthcare systems. Based on stakeholder feedback and evidence generated from the previous trial, an enhanced mobile health (mHealth) hearing screening will be implemented in all participating schools prior to the STAR intervention, and the telemedicine referral to specialty care (STAR intervention) will be moved from the clinic directly into the school.

This stepped-wedge cluster randomized trial is part of a larger hybrid type 1 effectiveness-implementation trial. The stepped wedge trial will evaluate the effectiveness of the STAR intervention in reducing loss to follow-up from referred school hearing screening in 3 regions of Alaska: Kodiak, Petersburg and Lower Yukon (n=23 schools, \~2,015 K-12 students/year). The STAR Intervention will be compared to the standard referral of a letter home to families. Cluster randomization at the level of school will be performed, with schools (clusters) randomized to one of two sequences. The effectiveness outcome (i.e., proportion of children who receive follow-up) will be evaluated over three academic years (2023-2026), with STAR rolled out in a stepwise manner for each of the two sequences (academic year 2024-2025 for sequence 1 and academic year 2025-2026 for sequence 2). The control periods for each sequence will be academic year 2023-2024 for sequence 1 and academic years 2023-2024 and 2024-2025 for sequence 2. Enhanced screening will be rolled out to both sequences at the same time (i.e., non-randomized) beginning academic year 2023-2024. An implementation evaluation will be conducted to refine and adapt the enhanced hearing screening and STAR intervention throughout the trial. Implementation data will be collected starting academic year 2022-2023 and then annually for each of the subsequent years.


Eligibility Criteria:
Inclusion Criteria:

* Enrolled in one of the participating schools in the 3 regions
* Children from grades (K-12) that are typically screened within participating schools
* Eligible regardless of age, gender, race, or ethnicity

Exclusion Criteria:

N/A
Post Market Clinical Follow-up of EUROSTEM Femoral Stem

EUROSSTEM is intended for use in primary and revision total hip replacement surgery.

Hip replacement is intended to provide increased patient mobility and reduce pain by replacing the damages hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.

As part of post market vigilance, EUROS will collect data on EUROSTEM performances and safety

Post market observational study. This study is multicenter, prospective, non comparative.

Eligibility Criteria:
Inclusion Criteria:

* Patient who received EUROSTEM
* Patient informed of its participation to the study
* Patient aged over 18 to date of surgery

Exclusion Criteria:

* Patient presenting a contraindication to EUROSTEM implantation.
* Patient who refused to participate to the study
* Vulnerable subjects
The Effect of AposTherapy on the Level of Pain, Function and Quality of Life in Patients With Neuro-muscular and Neurological Disorders

The purpose of the study is to examine the effect of a new biomechanical device and treatment methodology (AposTherapy) on gait patterns, pain, function and quality of life of patients with musculoskeletal and neurological disorders. Based on previous reports the investigators hypothesis that this therapy will have a positive effect on these measurements.


Eligibility Criteria:
Inclusion Criteria:

* Primary osteoarthritis
* Lower limb joint replacement
* Lower limbs fractures
* Spinal disorders including LBP w/wo refered symptoms, radiculopathy, spinal stenosis
* ligaments tear
* Meniscal tears

Exclusion Criteria:

* lack of balance (3 falls in the last year)
* incapable to complete a questionnaire •\>age 85
Musical Neglect Training for Patients With Visual Neglect

Music Neglect Training has been developed for patients with hemispatial neglect to improve their attention on the left side. The purpose of this study was to examine the immediate and carry-over effect of Musical Neglect Training on unilateral visual neglect. Standardized assessments (Albert's test and Line Bisection Test) were used to measure a range of visual field. A total of 6 musical exercises with tone bars which are aligned horizontally helped to improve attention and perception of the visual field on the left side.

Unilateral visual neglect from right hemisphere stroke is a condition that reduces a person's ability to attend to and process stimuli in one half, mostly left side, of their environment. This perceptual processing deficit can negatively affect individuals' daily living which in turn reduces functional independence. Music has been used as a therapeutic tool in a variety of settings to promote cognitive functions. In particular, music has been used to improve attention in the left sides for patients with visual neglect. Musical Neglect Training (MNT) has been developed for patients with visual neglect to improve attention in the left side.

The purpose of this study was to examine the immediate and longer-lasting effect of Musical Neglect Training (MNT) on unilateral visual neglect. A single-subject design was used, as participants served as their own control. Two individuals participated in this study. Participants underwent six individual MNT sessions. MNT uses musical exercises which are structured in pitch, time and tempo, and musical equipment (tone bars, keyboards, drums) configures to focus attention to the neglect visual field. Two standardized assessments (Albert's and Line Bisection Test) were used. The assessments were administered immediately before and after each of the 6 MNT sessions to assess the immediate effect of MNT. Moreover, follow-up testing was done one week after their 6th session to examine the longer-lasting effects of MNT. Paired t-test was used to examine the immediate effect, and both participants showed significant improvement with Albert's Test in immediate effect.

Eligibility Criteria:
Inclusion Criteria:

* patients with visual neglect after stroke
* right-handed
* medically stable
* no previous music therapy experiences
* no hearing impairments
* no cognitive deficits

Exclusion Criteria:

* hemianopia
* previous music therapy treatment experiences