cyrilzakka/clinical-trials huggingface dataset:
Investigation of the Ringer Perfusion Balloon Catheter (Ringer PTCA)

The objective of this study is to demonstrate safe and effective use of the Ringer perfusion balloon catheter for dilatation/pre-dilatation of coronary stenoses during percutaneous coronary intervention (PCI).

A prospective, multicenter, single-arm clinical study. The study will be conducted in 3 to 5 investigational sites in the US and Canada and will enroll up to 60 participants. The population for this study is adult participants undergoing non-emergent percutaneous coronary intervention (PCI) as a stand-alone procedure or following non-emergent diagnostic angiography performed during the same procedure.

Eligibility Criteria:
Inclusion Criteria:

* Male and Female subjects \>18 years old.
* Patients undergoing clinically indicated non-emergent PCI as a stand-alone procedure or in combination with diagnostic angiography during the same procedure.
* Study target lesion characteristics: a) native de-novo coronary stenosis of at least 70% visually estimated stenosis, or at least 50% visually estimated stenosis and shown to be physiologically significant by flow-mediated criteria (FFR \<0.80, IFR \<0.91); b) estimated reference vessel diameter 2.0-4.5mm; c) lesion length \<25mm; d) calcification not greater than mild.
* Per investigator assessment, the patient may benefit from inflation distal perfusion during balloon inflation. Examples include, but are not limited to: (i) LV systolic dysfunction with LVEF\<50% by any modality; (ii) a territory subtended by the target vessel downstream from the target lesion that is estimated to be in excess of 25% of viable LV mass; (iii) prior hemodynamic or electrical instablility during intervention on the target lesion; (iv) the potential to avoid placement of a coronary stent if a stent-like result can be achieved through prolonged balloon inflation.
* Female subjects of childbearing potential must have a negative pregnancy test per standard of care for PCI and be practicing contraception.
* Informed consent provided.

Exclusion Criteria:

* Hemodynamic or arrhythmic instability within 48 hours or a myocardial infarction within 72 hours of PCI.
* More than 2 lesions planned during index PCI.
* Procedural complication developing prior to PCI of study target.
* Ejection fraction (EF) \<25%.
* Creatinine clearance (Cr-Cl) \<25 mg/dL.
* Baseline flow at study target \<TIMI-2.
Development of a Youth Healthy Living Program With Underserved Adolescents at Rochester Alternative Learning Center

Approximately one third of the children and adolescents in the United States are either overweight or obese. Childhood obesity disproportionately affects specific racial and ethnic groups and households with low socioeconomic status and low parental education. The Alternative Learning Center (ALC) within Rochester School District 535 provides viable educational options for students who are experiencing difficulty in regular educational systems. A greater proportion of students at ALC are minorities, qualify for free and reduced lunch and receive special education services. These children are likely to have unique barriers to physical activity and healthy eating.

Specific Aims:

Aim 1: Examine the association between BMI and ethnic/ socioeconomic variables and behaviors related to physical activity and eating in ALC students.

Aim 2: Develop an age and culturally appropriate on-site program that promotes healthy lifestyle.

Investigators will assess the relationship between BMI and ethnicity, socioeconomic variables and behaviors related to nutrition and physical activity among 200 ALC students. Investigators will also conduct 6 gender stratified (3 boys, 3 girls) focus groups with students (n=24), up to 3 focus groups with their parents (n=24) and one focus group with staff and volunteers in order to understand perceived barriers towards healthy weight/nutrition/physical activity. Investigators will then utilize this information to co-develop a healthy living program at ALC. Investigators will finally test the feasibility of the program they develop over a period of 3 months in ALC students. Study findings will inform further research to test the efficacy and validity of the program developed at ALC in a subsequent school based trial with the future goal of obtaining funding for cluster randomized controlled trials among other schools in the region.

Eligibility Criteria:
Inclusion criteria:

* Rochester Alternative Learning Center students ages 12 years to 20 years
* Parents/guardians of ALC students
* ALC staff.

Exclusion criteria:

* Inability to assent or consent to participate in the study.
A Digital Solution for Breast Cancer Patients

Sidekick Health has developed an interactive digital health program (SK-421) to support breast cancer patients. The study will be a single center pilot study with an intervention group and a comparison group aiming to recruit 66 breast cancer patients prescribed to surgery, chemotherapy, radiation and/or hormonal therapy according to standard breast cancer treatment.

This pilot study will determine whether the digital health program, supporting lifestyle changes, can positively impact management of side effects, quality of life, physical activity and fitness and medication adherence in this patient population.

Patients will be randomized to receive either the standard of care (SoC) treatment alone or SoC with the addition of the digital healthprogram.

Many cancer survivors do not achieve previous levels of function and report prolonged fatigue, cognitive limitations, depression, anxiety, sleep problems, pain, or sexual dysfunction for up to ten years after diagnosis. In addition to symptoms related to the cancer itself, most cancer treatments cause physical and psychosocial side-effects that can affect a patient's physical function, mental well-being, and overall quality of life (QoL). These treatment-related side effects are most prominent during treatment but can also persist long after completion of the treatment with some becoming chronic and others developing as late side effects.

The European Society of Medical Oncology (ESMO) recommends encouraging patients towards adopting a healthy lifestyle including diet modification and exercise as well as addressing psychosocial needs.

Sidekick Health developed a 14-week digital health program (SK-421) with patient support aiming to increase the health related quality of life of breast cancer patients and improve management of treatment-related side effects.

The aim of this study is to assess the effectiveness of this digital health program when added to standard of care treatment. By comparing the effect of adding a digital solution to the standard of care with standard of care only, this study will investigate the impact of a holistic, digitally delivered health program on quality of life, physical activity, medication and treatment-related side effects. The main analysis is done after 14 weeks, with exploratory follow-up analysis at 26 and 38 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Female adults diagnosed with breast cancer stage 1, 2, 3 or 4
* Treatment plan includes surgery and (neo)adjuvant treatments: targeted-, chemo-, endocrine-, or radiotherapy.
* Fluent in verbal and written Icelandic or English
* Capacity to give informed consent
* Capacity to operate a smartphone

Exclusion Criteria:

* Not owning a smartphone compatible with the Sidekick Health app or not willing to have it installed on their device
* Not able to comply with study intervention/scheduled measures and visits, as assessed by oncologist
* Pregnancy
A Study Of Poly (ADP-Ribose) Polymerase Inhibitor PF-01367338 In Combination With Several Chemotherapeutic Regimens

Dose escalation phase 1 study of PARP inhibitor PF-01367338 in combination with chemotherapy in adult patients with advanced solid tumors


Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically confirmed solid tumors, Eastern Cooperative Oncology Group (ECOG) 0 or 1
* Patients with acceptable renal, hepatic, and bone marrow function

Exclusion Criteria:

* Symptomatic and/or unstable brain metastases,
* Any cancer treatment within 4 weeks from study entry
Feasibility and Safety of Total Percutaneous Closure of Femoral Arterial Access Sites in the Veno-arterial ECMO Patients

The most frequent access site for veno-arterial extracorporeal membrane oxygenation (VA-ECMO) is the common femoral artery (CFA), using either an open or percutaneous technique. Currently, percutaneous closure devices for femoral arterial access sites are approved for use only when a 10-F or smaller sheath has been used. However, the availability of the Perclose ProGlide (Abbott Laboratories, Chicago, IL) device has now made it possible to perform percutaneous vessel closure after using larger sheaths.The preclose technique using Perclose ProGlide, has been widely used in endovascular procedures. In a prospective randomized study, complication rates at the access site were similar in patients who underwent total percutaneous access (including percutaneous arteriotomy closure) than in those who underwent surgical cutdown and subsequent surgical closure. Total percutaneous closure of femoral arterial access sites increases patient comfort and decreases the rate of wound infections and lymphatic fistulas.\[6,7\] Furthermore, patients are mobilized and discharged earlier following the use of closure devices than with compression alone. Despite the above observations, no data have been published regarding percutaneous closure of femoral artery access sites in patients who have undergone VA-ECMO. In this study, we evaluated the safety and feasibility of a percutaneous closure technique using Perclose ProGlide to close the CFA access site after VA-ECMO.


Eligibility Criteria:
Inclusion Criteria:

- The study included all patients who underwent VA-ECMO and in whom Perclose ProGlide was deployed to achieve hemostasis during closure of the CFA site.

Exclusion Criteria:

* Patients were excluded if 24 hour and 30-day follow-up data regarding the access sites and other clinical outcomes were not available.
Understanding Hallucinations (Part II)

Rationale: Hallucinations occur in many patients with different kinds of diseases, including psychiatric, neurological and perceptual impairment. The origin of these hallucinations is only partly understood. This prevents correct prediction of treatment response and hampers the development of new, more effective treatment strategies.

Different subtypes of hallucinations resulting from different neuropathology may exist across diagnostic entities, and be responsive to different treatment strategies. Understanding the origin of these subtypes with use of fMRI and EEG can help to make rational treatment decisions on an individual basis and enhance the development of innovative treatment paradigms.

Objective: The primary objective is to find specific abnormalities on resting state fMRI related to the pathophysiology of different subtypes of hallucinations. Secondary objectives are to find EEG connectivity measures that are related to the pathophysiology of different subtypes of hallucinations, reveal correlating patterns of EEG and fMRI that underlie the experience of hallucinations across different disorders, and to examine the frequency of spontaneous synchronized burst activations in auditory and visual cortices using fMRI.

Study design: The investigators intend to examine neural correlates of hallucinations over different disorders using resting state EEG, fMRI and sMRI in an observational study.

Study population: A total of 140 hallucinating patients will be included, 20 of each of the 7 different diagnostic groups. As a control group, 140 non-hallucinating patients with the same disorder of similar severity will be included.

Main study parameters/endpoints: The main study endpoint is the difference in resting state correlates as measured with fMRI between hallucinating and non-hallucinating participants and between hallucinating individuals of different subtypes, namely: connectivity within the DMN and connectivity of the DMN to sensory cortices and the hippocampal-amygdala complex.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Participation in the study will entail an MRI scan of 40 minutes and an EEG measurement of 5 minutes. Total visit time, including preparations, will be approximately 2,5 hours. The risks associated with participation and the benefits to the individuals are negligible. The potential benefit to society in the future is considerable if the findings lead to optimization of treatment strategies and treatment response.


Eligibility Criteria:
Inclusion Criteria:

* Previous participation in the phenomenology/cognition study 13-059.
* Belong to one of the diagnostic groups as described above in 4.1.
* Written informed consent

Exclusion Criteria:

* \< 18 years of age
* Any contraindication for a 3Tesla MRI scan
Prevalence of Thyroid Dysfunction and Anti-thyroid Antibodies in Infertile Women

The study population will be divided into three groups:

* Group (A) consisting of 40 infertile women with either unexplained or anovulatory infertility with/without associated male factor of infertility,
* Group (B) consisting of 40 infertile women with tubal (mechanical) factor of infertility with/without associated male factor of infertility, and
* Group (C) consisting of 40 women with exclusive male factor of infertility and will be used as a control group.

  . All women will be subjected to:
* Informed consent
* Full history taking, including age, duration of infertility and whether primary or secondary
* General and pelvix examination
* Trans-vaginal ultrasonography
* Determination of hormonal profile (FSH, LH, Estradiol, Prolactin)
* Determination of ovulatory status
* Determination of of tubal patency
* Determination of presence of male factor
* Determination of TSH and antithyroid antibodies (antithyroglobulin and antithyroid peroxidase) blood levels

The study population will be divided into three groups:

* Group (A) consisting of 40 infertile women with either unexplained or anovulatory infertility with/without associated male factor of infertility,
* Group (B) consisting of 40 infertile women with tubal (mechanical) factor of infertility with/without associated male factor of infertility, and
* Group (C) consisting of 40 women with exclusive male factor of infertility and will be used as a control group.

  . All women will be subjected to:
* Informed consent
* Full history taking, including age, duration of infertility and whether primary or secondary
* General and pelvix examination
* Trans-vaginal ultrasonography
* Determination of hormonal profile (FSH, LH, Estradiol, Prolactin)
* Determination of ovulatory status (by previous documented history of induction of ovulation OR previous ultrasonography OR previous estimation midluteal serum progesterone, etc ...)
* Determination of of tubal patency (by previous hysterosalpingiography or laparoscopy)
* Determination of presence of male factor (by seminal fluid analysis)
* Determination of TSH and antithyroid antibodies (antithyroglobulin and antithyroid peroxidase) blood levels

Eligibility Criteria:
Inclusion Criteria:

* - Age: 18 - 38 years
* Infertile women whether due to functional, anatomical, male factors OR unexplained OR combined factors

Exclusion Criteria:

* - Age: below 18 and above 38 years
* Patients with autoimmune diseases (such as lupus and rheumatoid arthritis)
* Acute illness that require hospitalization
* Patients on the following medications: steroids, dopamine, iodine, amiodarone, lithium, donperidone, thyroid hormone, and phenytoin.
* Patients who work at night.
Brazil Nut Consumed on the Metabolic Profile, Oxidative Stress and Nutritive Microcirculatory Patterns

The purpose this research is to check if Brazil Nuts consumed improvement the metabolic profile, state redox and endothelial function in obese adolescents.

The purpose this research is to check if Brazil Nuts consumed improvement the metabolic profile (lipid profile, glucose, insulin), state redox (about glutathione peroxidase, isoprostane and LDL-ox) and endothelial function (by videocapillaroscopy) in obese adolescents (12-18 years).

Eligibility Criteria:
Inclusion Criteria:

pubertal girls obese (BMI \> 30 kg/m) -

Exclusion Criteria:

Consumption of nuts Loss weight before the research chronic disease (hypertension)

-
Morbidly Adherent Placenta, Diagnosis and Proper Management

The main idea of this study is to establish the diagnostic criteria for cases of morbidly adherent placenta (MAP) using different ultrasonographic modalities and compare this with intra-operative findings and postoperative histopathological assessment

This study is a clinical trial that will include all patients fulfilling the eligibility criteria and presented to the emergency unit of the department of Obstetrics and Gynecology in Sohag University hospital (Egyptian tertiary referral hospital) between February 2022 and February 2023. The attending physician will explain the nature of the study and all patients will be asked to sign an informed consent. A senior physician will evaluate the patient to confirm the diagnosis of placenta previa and degree of invasion in query accreta patients by using transabdominal and transvaginal US (Voluson,p8). 2D gray scale ultrasound, color and power doppler ultrasound will be performed firstly followed by 3D ultrasound.

All data will be saved in closed excel sheet and patients will be operated by a different surgical team, intraoperative staging of degree of placental invasion will be done according to clinical grading system by Collins et al., 2015 \[5\] in addition to histopathological evaluation when available, such as in cases of hysterectomy and cases with anterior placenta who were treated by excision of part of anterior uterine wall suitable for histopathological evaluation.

Eligibility Criteria:
Inclusion Criteria:

* o All pregnancies complicated with any degree of Placenta previa anterior, posterior or centralis undergoing pre-labor CS at gestational age (36+0 to 40+0), patients will be divided into subgroups according to number of previous CS, presence or absence of antepartum hemorrhage and qualifications of operative theatre in previous deliveries (public or private sector).

Exclusion Criteria:

* Women with history of medical co-morbidities such as chronic hypertension, Diabetes mellitus, renal diseases, autoimmune diseases, history of organ transplantation and immunosuppressive therapy, hematological diseases, history of thrombotic events, cardiopulmonary diseases, liver diseases Acute and chronic inflammatory diseases.
* Pregnancy induced medical disorders like: Gestational hypertension, preeclampsia, Gestational diabetes, Gestational thrombocytopenia and proteinuria.
* Fetal anomalies.
* Emergency CS if the patient is in labor.
Visual Dependence and Multisensory Balance Rehabilitation After Stroke

This cross-sectional study aims to investigate the prevalence of post-stroke visual dependence, and the effects of visual dependence on balance and gait. It also determines whether visual dependence could differentiate stroke patients with a history of falls from without.

Stroke participants will be recruited to measure the level of visual dependence, muscle strength, neurological recovery, balance ability, vertigo symptom, gait pattern and activities of daily living. This will calculate the prevalence of post-stroke visual dependence, and investigate the negative impact of visual dependence on balance and walking functions. This also determines whether the value of visual dependence could differentiate stroke patients with a history of falls from without a history of falls.

Eligibility Criteria:
Inclusion Criteria:

* 1) first stroke with 20-80 years of age
* 2) the time since onset is more than 6 months
* 3) can walk independently at least 10 meters without any walking devices and orthosis
* 4) normal cognitive function with scoring more than 24 on the Mini Mental State Examination scale
* 5) can understand and follow commands
* 6) can give informed consent

Exclusion Criteria:

* 1) other neurological disorders which could affect balance assessment
* 2) cerebellar stroke
* 3) diagnosis with central or peripheral vestibular diseases.
A New Approach to Target the Substrates of Persistent Atrial Fibrillation: The Sequential Substrate Ablation Approach

This is a prospective randomized controlled trial that compares the conventional stepwise approach with a new sequential substrate ablation approach for persistent atrial fibrillation.

A total number of 100 patients with persistent AF were randomized to receive either conventional stepwise ablation (conventional group) or a sequential substrate ablation (substrate group), both with the endpoint of AF termination. All patients were in AF before the procedure. The sequential substrate ablation consisted of pulmonary vein isolation (PVI) followed by cardioversion and linear ablation at the mitral isthmus, left atrial roof and cavotricuspid isthmus in order to modify the AF substrate. After achievement of bidirectional block, AF was re-induced and electrogram-based ablation was performed to achieve AF termination to sinus rhythm (SR). Endpoints are single-procedure outcome and total amount of RF ablation time required to terminate AF by electrogram-guided ablation.

Eligibility Criteria:
Inclusion Criteria:

* persistent atrial fibrillation lasting longer than 3 months
* no previous ablations
* at least 1 electrical cardioversion

Exclusion Criteria:

* non-persistent atrial fibrillation
* previous ablation procedures
Bilaterally Innervated Sensory Dorsal Digital Flaps for Sensory Reconstruction of the Fingers

Sensory coverage in the finger continues to be a challenging problem. This study reports sensory reconstruction of the fingers with the bilaterally innervated dorsal digital flaps and compares the results between the dual- and single-innervated flaps.The main evaluated outcomes are static 2-point discrimination and Semmes-Weinstein monofilament scores of the flap, fingertip pain and joint motion.

Pain was given subjectively by the patient using the visual analogue scale (VAS). The VAS consists of a 10 cm line that was grouped into mild (0-3 cm), moderate (4-6 cm) and severe (7-10 cm). Tinel's sign was rated as the following: grade 1=none; grade 2=mild, slight tingle; grade 3=moderate, very uncomfortable; and grade 4=severe, patient unable to use hand because of any stimulation of the neuroma.

Eligibility Criteria:
Inclusion Criteria:

* a soft-tissue defect in the areas where sensory return was considered important ●a defect with exposed bone or tendon in one finger
* the defect associated with the transected digital nerves in both sides
* a defect greater than 1.5 cm
* a patient aged 15 to 60 years

Exclusion Criteria:

* injuries to the dorsum of the finger or to the course of the vascular pedicle that precluded its use as the donor
* injuries to the dorsal branches of the digital nerves that precluded its use as donor nerves attached with the flap
* a defect less than or equal to 1.5 cm
* patient age \< 15 years or \> 60 years
Anatomic Altas of the Whole Human Body

The goal is the constitution of a statistical atlas of the human being morphology variability.

This work would be a significant step forward in the field of anatomy and biomechanical simulation.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers between the ages of 18 and 99 years.

Exclusion Criteria:

* Respiratory and cardiovascular pathology
* Claustrophobia
* Counter-argument to magnetic field exposure