cyrilzakka/clinical-trials huggingface dataset:
Ultrasound-guided Hydrosalpinx Aspiration During Egg Collection

· What we know: Hydrosalpinx and IVF About 40% of patients undergoing IVF have tubal disease and in 25%-30% of tubal disease patients there is fluid collection within the tube; hydrosalpinx. The amount of fluid in the hydrosalpinx is known to increase with ovarian stimulation (as in IVF) and often empties into the uterine cavity. Fluid from hydrosalpinges has been found to be detrimental to the growth and development of mouse embryos in vitro, and associated with reduced levels of endometrial integrins in vivo. This could be the explanation of the reduced pregnancy rates after IVF in patients with tubal disease and hydrosalpinx compared with those with tubal disease but no hydrosalpinx. This effect was evidence in both fresh and frozen embryo transfer cycles. Also there was a significant increase in miscarriage in association with hydrosalpinx.

The study aims to answer the question: does ultrasound-guided aspiration of ultrasound diagnosed hydrosalpinx at the time of egg collection improve the pregnancy rate in IVF?

· What we do not know: Treatment of hydrosalpinx and IVF Several studies in the literature have suggested that the treatment of hydrosalpinx pre-IVF would improve the pregnancy rate to a level similar to tubal disease patients without hydrosalpinx. The treatment modalities explored were salpingectomy, salpingostomy, tubal occlusion and ultrasound-guided aspiration either one month before or at the time of egg collection. All studies reported to date have been retrospective and with poor control design. A prospective randomised controlled trial is needed. All modalities have been associated with a similar improvement in pregnancy rate, but the least invasive modality is ultrasound-guided aspiration at the time of oocyte collection. We propose to conduct a prospective randomised controlled trial to evaluate the effect of ultrasound-guided aspiration (versus no aspiration) of hydrosalpinx at the time of egg collection on the pregnancy rate in IVF.

Eligibility Criteria:
Inclusion Criteria:

* healthy women, ASA class 1 (normal healthy) or class 2 (with mild systemic disease);
* undergoing IVF or ICSI and reaching the stage of egg collection;
* with ultrasonically diagnosed hydrosalpinx and identifiable during the phase of ovarian stimulation;
* giving written informed consent.

Exclusion Criteria:

* patients not giving written informed consent;
* patients cancelled for poor ovarian response;
* ultrasonically diagnosed hydrosalpinx and identifiable for the first time at egg-collection
An Observational Study of Participants With Type 3 Von Willebrand Disease on Prophylactic Standard-of-Care Treatment

This non-interventional study (NIS) is designed to collect information on the effectiveness and safety of treatment received in routine clinical care, as well as measure the health-related quality of life (HRQoL) of participants with Type 3 von Willebrand disease (VWD) receiving prophylactic therapy per local standard of care (SOC) over an observation period of at least 24 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of Type 3 von Willebrand disease (VWD), based on medical records
* Adequate hematologic, hepatic, and renal function
* Documented and confirmed previous use of SOC prophylactic therapy for VWD (1-3 times weekly, as per prescribed dose) and anticipation to remain on the same regimen during the study
* For participants of childbearing potential: agreement to remain abstinent or adhere to the contraception requirements

Exclusion Criteria:

* Inherited or acquired bleeding disorder other than Congenital Type 3 VWD
* History of gastrointestinal bleeding within 18 months prior to enrollment, or any previous diagnosis of angiodysplasia
* History of intracranial hemorrhage
* Previous or current treatment for thromboembolic disease or signs of thromboembolic disease
* Other conditions (e.g., certain autoimmune diseases) that may increase risk of bleeding or thrombosis
* History of clinically significant hypersensitivity associated with monoclonal antibody therapies or components of the emicizumab injection
* Use of systemic immunomodulators (e.g., interferon) at enrollment or planned use during the study, with the exception of anti-retroviral therapy
Intervention Module AGES

The AGES-CM consortium aims to study the interaction between the polymorphisms of the candidate genes related with neurodevelopment, neurotransmission, brain progressive changes, cognitive functioning and stressful life events (prospective- and retrospectively assessed) and the association of the interactions with structural and functional brain measures, neuropsychological performance, biochemical and oxidative status in both in patients and controls. The investigators study aimed to examine the effectiveness of a parallel, structured, and specific psychoeducational group intervention (PE) for adolescent patients and their families by comparing it with treatment as usual).

Objective: To assess the effectiveness of a structured psychoeducational group intervention for adolescents with early onset psychosis and their families. The intervention was implemented in parallel in 2 separate groups, by focusing specifically on problem solving strategies and structured psychosis-related information to manage daily life hassles associated with the disease in order to manage crises and prevent relapses.

Method: The investigators performed a 9-month, randomized, rater-blind clinical trial involving adolescent patients with early onset psychosis and 1 or both of their parents. The primary outcomes were number of hospitalizations, days of hospitalization, and visits to the emergency department. The secondary outcome measures were clinical variables and family environment and well being.

Eligibility Criteria:
Inclusion Criteria:

* The presence of at least one positive psychotic symptom (delusions or hallucinations)
* Before age 18 diagnosed by DSM-IV
* Aged between 14 and 19 years and lived at home with 1 or both parents, caregivers, or legal guardians.

Exclusion Criteria:

* The exclusion criteria were patient's drug abuse or dependence at the time of the intervention (drug use was not an exclusion criterion), the presence of any neurological developmental disorder or mental retardation and inability to engage in conversation or read in Spanish that may interfere with the progress of group treatment.
Validity and Reliability of the Sitting Assessment Scale in Cerebral Palsy

The Sitting Assessment Scale is a valid and reliable scale that evaluates sitting balance in Cerebral Palsy (CP). The validity and reliability study of the scale has been done, but it has not been adapted to Turkish language. The aim of this study is to adapt the Sitting Evaluation Scale, which evaluates sitting balance in Cerebral Palsy, into Turkish and to examine the validity and reliability of the Turkish version of the scale.

Cerebral Palsy will be participate the study between the ages of 2 and 18 years. Children's classified with GMFCS and MACS.

Evaluation will be applied to the volunteer participants after the translation steps of the Sitting Evaluation Assessment are completed. The validity of the scale will be examined in terms of construct validity and content validity. All evaluations will be performed in the clinic with the specialist physiotherapist.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Cerebral Palsy voluntary participation,
* Age between 2-18 years

Exclusion Criteria:

* Not voluntary to participate in the research,
* Botox in the last 6 months,
* Hip or spine surgeries in the last 6 months
Low Dose Atropine for Symptomatic Vitreous Floaters

The objective of this study is to identify a potential pharmacologic option by assessing whether 0.01% atropine may be effective for treating bothersome floaters as measured by scores on a modified NEI VFQ-25.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients within Prism Vision Group with ICD diagnosis of acute posterior vitreous detachment and none of the ocular comorbidities listed as exclusion criteria will be screened as potential study participants.

Exclusion Criteria:

* Patients with vitreous hemorrhage, other significant media opacity or vitreoretinal pathology, or history of pars plana vitrectomy will be excluded.
A Study to Evaluate ACT-132577 in Healthy Subjects and in People With Severe Kidney Disease

The primary purpose of this study is to investigate the fate of ACT-132577 in healthy subjects and in people with severe kidney disease


Eligibility Criteria:
Inclusion Criteria:

ALL SUBJECTS:

* Signed informed consent in the local language prior to any study-mandated procedure;
* Male/female aged 18 to 65 years (inclusive) at screening;
* Body mass index of 18.0 to 32.0 kg/m2 (inclusive) at screening. Body weight at least 50 kg;
* Women of childbearing potential must have a negative serum pregnancy test and use reliable birth controls up to 30 days after the end of study treatment.

HEALTHY SUBJECTS:

* Normal renal function confirmed by the estimated glomerular filtration rate (eGFR) determined at screening;
* Healthy on the basis of physical examination, cardiovascular assessments and laboratory tests.

SEVERE RENAL FUNCTION IMPAIRMENT SUBJECTS:

- Severe renal function impairment is defined by eGFR estimated at screening between 15 mL/min/1.73 m2 and 29 mL/min/1.73 m2 (inclusive).

Exclusion Criteria:

ALL SUBJECTS:

* Pregnant or lactating women;
* Known hypersensitivity to ACT-132577 or drugs of the same class, or any of their excipients;
* Known hypersensitivity or allergy to natural rubber latex;
* Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.

SEVERE RENAL FUNCTION IMPAIRMENT SUBJECTS:

* End-stage renal disease that requires dialysis;
* Hemoglobin concentration \< 9 g/dL;
* History of severe renal stenosis;
* Serum potassium concentration \> 5.5 mmol/L;
* Presence of severe cardiac disease;
* History of clinically relevant bleeding disorder;
* Presence of any organ disorder, with the exception of renal function impairment, or use of any medication which might interfere with the pharmacokinetics of ACT-132577;
* Known life-threatening disease with a life expectancy of less than 1 year;
* Presence of unstable diabetes mellitus.
Effect of Dexlansoprazole on Bone Homeostasis

The purpose of this study is to evaluate the effect of dexlansoprazole modified release (MR), once daily (QD), on bone homeostasis.

Research on drugs that affect bone homeostasis have shown changes in levels of bone formation and resorption biomarkers. This study will evaluate the effect of dexlansoprazole on bone homeostasis by assessing changes in biochemical markers of bone formation and bone resorption. This study will also assess changes in bone mineral density by dual-energy x-ray absorptiometry scan and other markers of bone homeostasis.

The study will consist of a 12-week screening period, a 26-week treatment period with a total of 5 visits during the treatment period and a follow-up visit at Week 52 for bone mineral density assessment.

Eligibility Criteria:
Inclusion Criteria:

* Is postmenopausal female in general good health with a body mass index of ≥18 and ≤30 kg/m2.
* Must have biochemical markers of bone formation, procollagen type 1 N-terminal propeptide and bone-specific alkaline phosphatase, and bone resorption, crosslinked β-C-terminal telopeptide of type 1 collagen and urine N-telopeptide within normal postmenopausal female ranges.
* Has not taken proton pump inhibitor medications within 6 months prior to screening and agrees to refrain from taking them through the last dose of study drug, except study-supplied dexlansoprazole or esomeprazole.

Exclusion Criteria:

* Has parathyroid hormone or thyroid stimulating hormone levels outside of the reference range at Week -12 and has 25-OH-D level \<32 ng/mL at Week -2.
* Has baseline bone mineral density by dual-energy x-ray absorptiometry defined as a T-score lower than -2.0 at the total hip, spine, or femoral neck based on Caucasian reference values.
* Has a disorder strongly associated with osteoporosis
* Has a history of lumbar laminectomy, vertebroplasty, vertebral deformity or severe lumbar scoliosis that interferes with measurement or performance of the dual x-ray absorptiometry .
* Has a history or clinical manifestations of uncontrolled or significant metabolic, hematologic, pulmonary, cardiovascular, gastrointestinal, neurologic, hepatic, renal, urologic, immunologic, or psychiatric disorder as determined by the investigator which may affect the ability of the subject to participate or potentially confound the trial results.
* Has family history of genetic bone disorders.
Physiologic Mechanisms in Pediatric Traumatic Brain Injury (TBI)

The aims of this study explore the relationships between cerebral vasospasm, apolipoprotein-E (apo-E) genotype, physiologic symptoms, and neurocognitive outcomes that may either intensify or ameliorate secondary injury, for children with a traumatic brain injury. Exploring the apo-E genotype will help us know if injury response is altered in certain children and will aid in developing interventional approaches.

The purpose of this study is to advance knowledge of neurocognitive outcomes in pediatric traumatic brain injury (TBI) patients by exploring the relationships between physiologic factors of cerebral vasospasm, apolipoprotein E (apo-E) allele, biomarkers, and neurocognitive outcomes. This study is a funded project within Duke University School of Nursing National Institutes of Health/National Institute of Nursing Research (NIH/NINR) P30 Center of Excellence Grant. This study will continue on with some of the work of a small intramural grant study determining the feasibility of conducting pediatric TBI research at DUHS. It will advance the measurement of vasospasm by translating the use of the Transcranial Doppler (TCD) ultrasound to neuromonitoring in children. To date, this will be the first pediatric study examining the relationship of cerebral vasospasm, apo-E, and biomarkers with neurocognitive outcomes. Unlike adult TBI patients, cerebral vasospasm, apo-E, and biomarker collections have yet to be examined in pediatric neurotrauma patients in the Duke University Health System. Although neurocognitive outcomes are a standard of care for TBI patients at Duke University Health System (DUHS), the data has yet to be examined within the realm of pediatric neurodiagnostic physiologic measures. By obtaining preliminary data in 35 patients, it will allow for the evaluation of multi-diagnostic measures in pediatric TBI patients, as well as provide data for future funding for a larger regionally-scale study.

Eligibility Criteria:
Inclusion Criteria:

1. TBI patients admitted to the pediatric intensive care service (PICU)or pediatric progressive care unit
2. Range in age from birth to 15 years
3. TBI with a Glasgow Coma Scale of 3-15
4. Acoustic window for adequate transcranial doppler (TCD) ultrasound
5. English or Spanish speaking or understanding parent/legal guardian to consent
6. Access for a buccal swab for genotyping

Exclusion Criteria:

1. Non-English or Spanish speaking parents/legal guardian
2. Children with a previously diagnosed neurodevelopmental delay
Phase 1 Absorption Distribution Metabolism and Excretion of AQX-1125

This study is conducted to evaluate the absolute bioavailability, metabolism and elimination pathways of AQX-1125 in healthy male and female subjects.

This is a single-centre, open-label, non-randomised, 2-part, sequential dose study in healthy male and female subjects. It is planned to enrol a single cohort of 8 healthy subjects (4 male and 4 female) who will participate in Part 1 and Part 2 of the study.

In Part 1, each subject will receive a single oral dose of AQX-1125 followed by an IV microtracer dose of carbon-14-AQX-1125 (\[14C\]-AQX-1125). In Part 2, each subject will receive a single oral dose of \[14C\]-AQX-1125.

Eligibility Criteria:
Inclusion Criteria:

* Healthy males
* Healthy females of non-child bearing potential
* BMI 18.0 to 35 kg/m2

Exclusion Criteria:

* History of any drug or alcohol abuse in the past 2 years
* Regular alcohol consumption in males \>21 units per week and females \>14 units per week (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine)
* Current smokers and those who had smoked within the last 12 months; this included cigarettes, e-cigarettes and nicotine replacement products. Positive cotinine test result at screening and each admission
* Clinically significant abnormal clinical chemistry, haematology, urinalysis or electrocardiogram (ECG)
Reinflation After Early Tourniquet Release in Total Knee Arthroplasty

This study is aimed to determine the efficacy and the safety of the tourniquet reinflation after early tourniquet release in total knee arthroplasty, compared to the method of early deflation without reinflation. The investigators hypothesized that the reinflation after early release of the tourniquet would be effective in terms of improved visualization of the surgical field and decreased operation time and blood loss, whereas it would increase tourniquet-related complication due to longer tourniquet-use time.

Total knee arthroplasty(TKA) is mostly performed with tourniquet applied, because it allows decreased intraoperative blood loss, better visualization of surgical field and better cement fixation of the implants, compared to the TKA without using tourniquet. However, there remains a controversy about the timing of tourniquet release, so the tourniquet may be unreleased throughout the whole operation time or released early just after cement fixation of the implants, atc. Early tourniquet release is generally aimed to control hidden arterial bleeding which would not be revealed if the tourniquet was unreleased. This method was reported to reduce arterial bleeding and its related complications, but it was also known that increase intraoperative bleeding, incidence of transfusion, and operation time. On the other hand, late tourniquet release, which the tourniquet is unreleased until the wound is closed, is reported to increase tourniquet-use time and related complications owing to longer tourniquet time, although it gives shorter operation time. The investigators have been used a way of reinflation of tourniquet after early release, once the arterial bleeding was controlled sufficiently, to balance the advantages and disadvantages of the early tourniquet release. The investigators were able to control arterial bleeding during the time the tourniquet was released, and the remained procedures were performed conveniently with good visualization of the surgical field after the tourniquet was reinflated again. However, there was no previous studies about the efficacy and the safety of the way of reinflation after early release of the tourniquet in the literature. Therefore, the investigators ask in this study whether the reinflation after early tourniquet release has advantages over the method of early tourniquet release without reinflation, in terms of efficacy and safety.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of primary osteoarthritis of the knee
* Scheduled for elective total knee arthroplasty
* Written signed consent

Exclusion Criteria:

* Revision TKA
* Diagnosis other than primary osteoarthritis
* Intra-articular indwelling drainage
* Refusing participate
A Multicomponent Technology Supported Care Delivery for Older Patients With Hematologic Malignancies (The M-Tech Study)

This is a randomized controlled trial to assess the feasibility and preliminary efficacy of a multicomponent technology-supported care delivery intervention trial in 110 older patients with hematologic malignancies \[acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), multiple myeloma (MM), and diffuse large b-cell lymphoma (DLBCL)\] receiving outpatient chemotherapy on treatment-related toxicities, patient-reported outcomes, healthcare utilization, and inflammatory and epigenetic markers.

Compared to younger adults, older adults with cancer are more likely to have age-related vulnerabilities such as functional impairment and co-existing medical conditions. They are also often on many medications. As a result, older adults are more likely to experience treatment-related toxicities. These toxicities can lead to increased healthcare utilization (e.g., hospitalization, emergency room visits), decreased quality of life and functional status, and reduced survival. In addition, a disproportionate number of older adults live in rural areas which often limit access to healthcare. Therefore, there is a need to better support older adults with hematologic malignancies during the course of their treatment to decrease treatment-related toxicities so they can continue to receive treatment. The proposed study will investigate whether digital health technologies can support older adults in various aspects of their cancer care.

Eligibility Criteria:
Inclusion Criteria

* Age ≥60 years
* Have a new diagnosis of AML, MDS, MM, and DLBCL
* Have a plan to receive outpatient chemotherapy for at least 4 months (patients may enroll within the first 2 weeks of chemotherapy initiation if they do not have grade 2 or higher non-hematologic adverse event)
* No plan to or unlikely to proceed with autologous or allogeneic hematopoietic stem cell transplantation (SCT) in the following 5 months (if SCT is planned after 4 cycles of chemotherapy in the case of MDS or myeloma, patients are allowed to enroll)
* English speaking
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-3
* No medical contraindications for exercise per oncologist
* Able to walk 4 meters as part of Short Physical Performance Battery measured walk (with or without the assistive device)
* Able to provide informed consent

Exclusion Criteria:

• None
Evaluate the Safety and Efficacy of TGR 1202 in Patients With Relapsed or Refractory Hematologic Malignancies

The purpose of this study is to evaluate the safety and effectiveness of TGR-1202 in patients with advanced hematologic malignancies.


Eligibility Criteria:
Inclusion Criteria:

* Refractory to or relapsed after at least 1 prior treatment regimen;
* Eastern Cooperative Oncology Group (ECOG) score of 0 to 2;
* At least 18 years of age.

Exclusion Criteria:

* Any major surgery, chemotherapy or immunotherapy within the last 21 days (limited palliative radiation is allowed ≥ 2 weeks);
* Autologous hematologic stem cell transplant within 3 months of study entry or Allogeneic hematologic stem cell transplant within 12 months;
* Known hepatitis B virus, hepatitis C virus or HIV infection;
* Previous therapy with GS-1101 (CAL-101), IPI-145 or any drug that specifically inhibits the PI3K or mTOR pathway;