cyrilzakka/clinical-trials huggingface dataset:
A Study to Explore Personalized Treatment for Patients with Recurrent Gynecological Malignancies Based on MTB

This is a non-interventional, real-world study divided into two parts: a retrospective study and a prospective study.

The main question it aims to answer is:

Will genomic sequencing and molecular tumor boards lead to clinical responses in patients with recurrent ovarian, cervical, or endometrial cancer? The retrospective arm will analyze data from patients with recurrent gynecological malignancies (ovarian, cervical, or endometrial) who underwent multidisciplinary consultations at our institution from January 2022 onward. Data collected will include tumor tissue genomic sequencing results, medical histories, multidisciplinary consultation recommendations, and subsequent treatment courses. This analysis will examine the implementation and clinical efficacy of personalized targeted therapies guided by molecular tumor profiling and multidisciplinary consultation.

The prospective arm will enroll 200 patients with recurrent gynecological malignancies (ovarian, cervical, or endometrial) referred for multidisciplinary consultation. Tumor tissue and blood samples will undergo next-generation sequencing (NGS) to determine molecular tumor profiles. A multidisciplinary expert panel will formulate individualized treatment strategies based on these profiles, patient clinical data, and treatment history. Attending physicians will determine the final treatment plan, integrating multidisciplinary recommendations with patient preferences, comorbidity considerations, drug toxicity assessments, insurance coverage for off-label medications, and the availability of investigational drug trials. This arm aims to observe and evaluate the clinical efficacy of personalized treatment plans developed through molecular tumor profiling and multidisciplinary consultation.


Eligibility Criteria:
Inclusion Criteria:

* Patients with recurrent ovarian, cervical, or endometrial cancer referred for multidisciplinary consultation by a gynecological oncologist;
* Presence of at least one evaluable lesion;
* Willingness to participate in multidisciplinary consultation;
* Age 18 years or older;
* Sufficient tumor tissue for next-generation sequencing (NGS) with a tumor content greater than 32%;
* Informed consent provided by the participant, indicating understanding of the study procedures and willingness to participate.

Exclusion Criteria:

* Patients with concurrent malignancies;
* Pregnant patients.
Improving Services and Outcomes for Children With Autism Spectrum Disorder (ASD)

Based on the need to characterize and improve early intervention services for minority and under-resourced children with ASD, this study translates a manualized and proven training model to examine its impact on the use of evidence-based practices (EBP) by early intervention providers, and to examine its relationship to child and family outcomes. By highlighting the impact of EBP-focused training on participating providers, children, and families, findings of the proposed study have the potential to effect significant change in the organization and delivery of early intervention services for minority and under-resourced children with ASD.


Eligibility Criteria:
Inclusion Criteria for Providers:

* Providers must be employed by an Infants and Toddlers Program; and
* Serve at least one eligible child with ASD

Inclusion Criteria for Families/Children:

* Children must be between 12 months, 0 days and 35 months, 30 days of age at entry into the study;
* Children must meet criteria on the Autism Diagnostic Observation Schedule (ADOS) for ASD or autism; and
* Caregiver and child must be available for all assessments

Exclusion Criteria for Families/Children:

* Children will be excluded if they are in foster care or wards of the state
* Caregiver must be fluent in speaking and understanding the English language
Open-Label Natalizumab Safety Extension Study

The primary objective of this study is to determine the safety and the immunogenicity of extended treatment with natalizumab when administered at a dose of 300 mg intravenously (IV) to subjects with multiple sclerosis (MS) who have completed natalizumab Studies C-1801, C-1802, or C-1803.


Eligibility Criteria:
Inclusion Criteria:

* Must give written informed consent.
* Must be an MS subject who has completed natalizumab Study C-1801, C-1802 or C-1803

Exclusion Criteria:

* History of, or available abnormal laboratory results, indicative of any significant disease that would preclude treatment.
* History of severe allergic or anaphylactic reactions or known drug hypersensitivity
* A clinically significant infectious illness within 30 days prior to study entry.
The Effect of Pregnancy and Labour on the Pelvic Floor Diagnosed With 3D and 4D Ultrasound

Injuries to the pelvic floor muscles and fascias during delivery and childbirth may lead to urinary incontinence (25-45 %), faecal incontinence (11-45%), pelvic organ prolapse (7-23%), sexual dysfunction (15-33 %) and chronic pain syndromes (4-15%). Pelvic floor muscle injuries are not easy to diagnose as they are not visible when looking at surface anatomy during a standard gynaecological examination. The investigators are therefore in urgent need of better tools to diagnose these injuries. Having a reliable and easily accessible tool enables studies of the consequences of such pelvic floor muscle injuries. It also makes it possible for us to explore the effect of interventions such as pelvic floor muscle training and surgery in patients with and without pelvic floor muscle injuries. The investigators have previously presented data to support the reliability and the validity of the three and four dimensional (3 and 4D) ultrasound technique used to define pelvic floor muscle anatomy in healthy volunteers and have now a tool to study women before and after delivery. At the Department of Obstetrics and Gynaecology, Akershus University Hospital there are approximately 4500 deliveries annually and 1500 women are giving birth for the first time.

Challenges: The invitation to participate in the study will be given to all women expecting their first child fulfilling inclusion criteria. The biggest challenges in the project will be logistical. To be able to inform, recruit and follow women having their first child is a challenge in it self.

Applications: If it is possible to identify a risk group for pelvic floor injuries before delivery, it might be ethical to recommend a prophylactic caesarean section to avoid disabling incontinence and prolapse later in life.


Eligibility Criteria:
Inclusion Criteria:

* Women giving birth to their first child at Akershus University Hospital, Norway
* Must understand spoken and written Norwegian

Exclusion Criteria:

* Previous pregnancy of more than 16 weeks
* Serious illness mother or child
* Birth before pregnancy week 32
SASL Swiss Cirrhosis Cohort

This is a national prospective long-term multicentre observational cohort study following patients with cirrhosis in order to systematically and longitudinally record epidemiological, clinical, histological, psychosocial and patient-reported data and biobank biological material from patients with cirrhosis.

The central element of all scientific operation and productivity in the Swiss Cirrhosis Cohort Study (SSCiCoS) is the so-called "nested project" (NP). Based on the evolving large pool of data and biological samples, SSCiCoS investigators use the data pool in order to investigate specific hypotheses and questions.

For patients with end-stage cirrhosis there are no treatment options other than transplantation, a medically and ethically challenging procedure. The challenge therefore is to prevent the need for liver transplantation in as many patients with cirrhosis as possible.

In order to reach this aim, patients with cirrhosis should be identified and followed regularly according to the highest standard of current knowledge. Numerous aspects of the disease need to be detailed: its epidemiology in Switzerland, its pathophysiology including the mechanism of scar tissue generation and resolution, the associated immune dysfunction and subsequent organ failures, disease related psychosocial and behavioural factors, perceived burden of liver cirrhosis in patients, diagnostic and prognostic biomarkers for disease dynamics, both progression and regression of disease, and stage-specific therapeutic strategies.

This is a national prospective long-term multicentre observational cohort study following patients with cirrhosis in order to systematically and longitudinally record epidemiological, clinical, histological, psychosocial and patient-reported data and biobank biological material from patients with cirrhosis.

Eligibility Criteria:
Inclusion Criteria:

* A) Patients with chronic liver disease and histologically proven cirrhosis
* B) Control subjects with no signs of cirrhosis

Exclusion Criteria:

* Age \<18 years
* patients who developed hepatocellular carcinoma (HCC) and/or cholangiocellular carcinoma (CCC)
Infection Prevention After TKA With or Without Vancomycin

Prospective, Randomized, Double Blinded Trial Comparing Clinical, Radiological and Laboratory Outcomes in prevention of infection after Total Knee Arthroplasty With or Without Vancomycin.

Infection after surgery is one of the most common complication after total knee replacement. Our prospective randomized study is intended to show if addition of vancomycin to the joint before the wound closure will decrease infection after operation.

Eligibility Criteria:
Inclusion Criteria:

* Gosnartrosis

Exclusion Criteria:

* no informed consent to participate in the study age under 40 multilligament injury or single plane knee instability another musculoskeletal disorders in lower limb ASA score \> II
No Resistance After Long Term Treatment SERETIDE

This multi centre, double blind, comparator controlled, parallel group study is to determine whether asthma treatment with high doses of fluticasone propionate (FP) redirects a Th2/ eosinophil response towards a more treatment resistant neutrophil/ monocyte response and whether this occurs to a lesser extent in asthmatic subjects treated with the combination product of salmeterol and fluticasone propionate (SFC). The primary endpoint is the mean change in priming of blood neutrophils assessed by marker A17. After a run-in period of 4 weeks subjects will enter a 24 weeks high dose treatment (FP 500 mcg bd) or a 12 week medium-dose treatment with FP 250 mcg bd followed by a 12 week treatment with SFC 50/ 250 mcg. At the visits lung function measurements, ACT, eNO measurements and a blood sample will be performed. A total of 50 randomised subjects are planned to be recruited in this study


Eligibility Criteria:
Inclusion:

* Positive skin prick test
* History of asthma (GINA)
* Regular treatment with FP with/without LABA at least 4 weeks before visit 1
* History of recurrent episodes of wheezing, breathlessness, chest tightness and/ or coughing in the previous year.
* Able to use a DISKUS™ inhaler
* Able perform reproducible lung function tests at Visit 1

Inclusion criteria treatment period:

* FEV1 % predicted \> 70%
* ACT score \< 25 after run-in period

Exclusion criteria run-in period:

* Hospitalised for asthma within 4 weeks prior to Visit 1
* Acute upper respiratory tract infection or a lower respiratory tract infection within 4 weeks prior to Visit 1
* Oral, parental or depot corticosteroids within 4 weeks prior to Visit 1
* Hepatic impairment or other significant disease

Exclusion criteria treatment period:

* Non-compliance (\< 70%)
Conversational AI Study

This is a prospective, collaborative, mixed-methods study which includes anesthesiology trainees receiving one active intervention - a conversational artificial intelligence (CAI) simulation. The goal is to explore the capability of AI to provide high-fidelity simulations that can ultimately improve how healthcare professionals handle difficult conversations such as disclosing medical errors or mistakes.


Eligibility Criteria:
Inclusion Criteria:

* Hospital providers, including nurses, physician assistants, physicians, physician trainees, and other healthcare workers at Lucile Packard Children's Hospital (LPCH) and affiliated facilities who communicate with patients daily will be included

Exclusion Criteria:

* Participants with reported severe motion sickness
* Nausea
* Seizure disorder
* Currently using chronotropic heart medications, such as β blockers
Post-prandial Glucose in Healthy Indian Subjects

The study is designed to determine the extent to which a plant-based ingredient on different food formats affect blood glucose responses in healthy subjects


Eligibility Criteria:
Inclusion Criteria:

* Willing to give consent to participate in the study in writing;
* Healthy male and female subjects, between the age of ≥20 and ≤50 yrs of age at first screening visit;
* Body Mass Index (BMI) between ≥18 and ≤ 25 kg/m2;
* Apparently healthy: no medical conditions which might affect study measurement, as judged by study physician and/or measured by questionnaire, and/or assessed by haematology, blood chemistry and urinalysis;
* Willing to comply to study protocol during the study;
* Agreeing to be informed about medically relevant personal test-results by study physician;
* Willing to refrain from drinking of alcohol on and one day before the blood withdrawal;
* Fasting blood glucose value of volunteer is ≥ 3.4 and ≤ 6.1 mmol/litre (i.e. 62-110 mg/dl) at screening;
* Haemoglobin level within clinically acceptable range (for male 12 to 17 gm/dL and for females 11 to 15 gm / dL; both inclusive)

Exclusion Criteria:

* Being an employee of Unilever or CRO;
* Chronic smokers, tobacco chewers and drinkers;
* Participation in any other biomedical study 3 months before screening visit day of this study and/or participating in any other biomedical study during the screening period;
* Use of medication which interferes with study measurements including vitamins, tonics;
* Reported intense exercise ≥10 h/week;
* Reported weight loss/gain ≥ 10% of body weight in the 6 months preceding screening
* Blood donation for 2 months prior to screening;
* Urine analysis that showed any drug abuse;
* Allergy to any food or cosmetics;
* If female, not being pregnant or planning pregnancy during the study period;
* If female, lactating or has been lactating for 6 weeks before pre-study investigation and/or during the study period.
Study of Subretinally Injected AAVB-081 in Patients With Usher Syndrome Type IB (USH1B) Retinitis Pigmentosa

The purpose of the 081-101 study is to evaluate the safety and tolerability of a single subretinal injection of AAVB-081 in USH1B patients with retinitis pigmentosa due to a mutation in the MYO7A gene. The study will also assess the initial efficacy following AAVB-081 administration.


Eligibility Criteria:
Inclusion Criteria:

* Molecular diagnosis of USB1B due to MYO7A mutation
* Willingness to adhere to protocol per informed consent

Exclusion Criteria:

* Unwillingness to meet the requirements of the study
* Participation in a clinical study with an Investigation Product in the past 6 months
* Previous participation in another Gene Therapy trial
* Any condition that would preclude subretinal surgery
* Complicating ocular and/or systemic diseases
The Role of Reactive Oxygen Species in Ischaemia-Reperfusion Injury of the Transplanted Kidney

Measurement of reactive oxygen species production and antioxidant system status before and directly after reperfusion of the transplanted kidney and influence of oxidant stress on kidney function in 2 and 6 weeks.

Oxidative stress is one of the most important factors in ischaemia-reperfusion injury to the transplanted organ. In kidney transplant recipients following factors were measured: glutathione level, activities of glutathione peroxidase (GSH-PX), catalase (CAT) and superoxide dismutase (SOD) and superoxide anion production by granulocytes in whole blood without and after the stimulation with zymosan.

Blood was sampled from peripheral vein (before reperfusion) and directly from renal vein (5 and 15 minutes after reperfusion).

Transplanted kidney function was evaluated by the incidence and length of Delayed Graft Function and serum creatinine level in 2 and 6 weeks after transplantation.

Eligibility Criteria:
Inclusion Criteria:

* consecutive patients accepted for and undergoing cadaveric kidney transplantation

Exclusion Criteria:

* no informed consent
Effects of Myofascial Induction Therapy on Pressure Pain and Ankle Range of Motion.

In this study, it will be assessed if there are changes in ankle dorsiflexion and pressure pain after performing the myofascial induction technique in the calf.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with no pain and with 18 to 30 years old.

Exclusion Criteria:

* (1) Diagnosis of lower limb injury, including any tendinopathy, bursitis, ligamentous involvement or fasciitis ,
* (2) history of lower limb surgery ,
* (3) participants were required not to have undergone ankle stretching or any other treatment,
* (4) diabetes due to possible alteration of arterial distal circulation,
* (5) deformities of the toes, such as hammer toes and hallux valgus. All subjects signed an informed consent form before participating in the study
In Vivo Raman Spectroscopy of Human Capillary Beds

The LighTouch device shines imperceptible red light into the skin and measures the light that comes back out using the method of Raman Spectroscopy. Some of this light is color shifted and some is not. Using a proprietary numerical recipe, the LighTouch device combines the signals in this remitted light and calculates hematocrit, glucose, protein and potentially other analytes. Thus the LighTouch device produces information without painful physical insult to the patient and can trend changes in these blood analytes in order to predict the need for intervention.

The leading preventable cause of death for all people between 18 and 45, world-wide, military or civilian is uncontrolled internal bleeding i.e. hemorrhage. (A. Sauaia et al, J. Trauma 38, 185-193 (1995)). Internal bleeding can be very difficult to reliably detect when there is no visible external injury and the rate of blood loss is not very rapid. Two known leading indicators of blood loss are fluctuations in hematocrit and blood protein concentration. Monitoring of either of these analytes requires a blood draw and at least 3-5 minutes to obtain a single measurement. The LighTouch device shines imperceptible red light into the skin and measures the light that comes back out using the method of Raman Spectroscopy. Some of this light is color shifted and some is not. Using a proprietary numerical recipe, the LighTouch device combines the signals in this remitted light and calculates hematocrit, glucose, protein and potentially other analytes. Thus the LighTouch device produces information without painful physical insult to the patient and can trend changes in these blood analytes in order to predict the need for intervention. Previous IRB approved clinical trials over the last 10 years demonstrated useful performance for blood glucose and now the hematocrit and protein analytes are ready to be tested. Since hematocrit and protein concentrations change during hemodialysis it provides an ideal model to monitor these fluctions over time and assess the precision and accuracy of the LighTouch device for these analytes. This technique will not affect the usual dialysis treatment in any way. The subject will place one finger into the machine for exposure to the incoming light signal and sensors within the machine will detect light scatter from specfic analytes such as hematocrit. Literally hundreds of individuals have experienced the LighTouch device since 1999 and there has never been an unpleasant response or adverse outcome. The system is analagous to having a laser pointer shining on one's finger-tip. The ultimate goal of this research is to develop the device into a reliable non-invasive measure of critical blood elements that can be determined at the patient's side.

Eligibility Criteria:
Inclusion Criteria:

* adult stable on dialysis and able to consent

Exclusion Criteria:

* inability to acquire IVRS signal
Detection and Quant of Differences in Hodgkin Lymphoma and Diffuse Large B-cell Lymphoma Using Positron Emission Tomography/Computed Tomography (PET/CT)

RATIONALE: Imaging procedures, such as positron emission tomography or computed tomography, may help in detecting differences between Hodgkin lymphoma or diffuse large B-cell lymphoma cancer cells. PURPOSE: This clinical trial is studying positron emission tomogaphy and computed tomography in determining differences in Hodgkin lymphoma and diffuse large B-cell lymphoma.

OBJECTIVES:

I. Assess the feasibility of detection and quantification of differences in the temporal and spatial distribution of FDG uptake between lesions of HL and DLBCL.

OUTLINE:

Patients undergo fludeoxyglucose F18 (FDG) positron emission tomography/computed tomography scans 60 and 180 minutes after FDG administration.

After completion of study, patients are followed for 24 hours.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with a pathologically-proven diagnosis of classic HL or DLBCL with measurable disease by any imaging technique or physical examination.

Exclusion Criteria:

* Pregnant or nursing,
* Uncontrolled diabetes mellitus,
* Active infection,
* Inability to give informed consent or to comply with all study procedures,
* Subjects may be excluded at the discretion of the principal investigator or study team members.
Cassia Cinnamon for Glucose Uptake in Young Women

The purpose of this study was to compare the acute effects of 5g of Cassia cinnamon, 50 minutes of endurance exercise performed at 70% of the heart rate reserve (correlated to VO2max), and 5g of cellulose placebo on blood glucose, serum insulin and insulin sensitivity following an oral glucose tolerance test 3 hours after administration of each intervention.


Eligibility Criteria:
Inclusion Criteria:

* Sedentary
* BMI: 27-45
* DXA body fat % greater than 30%
* 18-30 years of age
* Healthy
* From the Baylor University campus and surrounding community
* Regular sleep habits

Exclusion Criteria:

* Not regular users of any species of cinnamon
* Not diagnosed with any metabolic disorder or chronic medical condition
* Not taking prescription medications for 2 months before the study
* Not taking ergogenic aids for 2 months before the study
* Not taking oral contraceptives for 2 months before the study
* No IUD placed for 2 months before the study
Investigate Bladder and Prostate During Emptying With Intermittent Catheter

Explorative study investigating the urinary bladder and prostate during intermittent catheterization in healthy male adults by use of MR-scanning.

12 healthy male adults will be enrolled in the investigation. The study includes one study visit where MR-scans of the bladder and prostate will be performed during normal voiding as baseline measurement followed by measurements during emptying of the bladder with an intermittent catheter (SpeediCath CH12 standard male intermittent catheter).

Eligibility Criteria:
Inclusion Criteria:

* Male
* Has given written informed consent
* Be at least 18 years of age and have full legal capacity

Exclusion Criteria:

* Participate in any other clinical investigation
* Has symptoms of UTI (Investigator's judgement)
* Has known abnormalities and/or diseases in the bladder and/ or the lower urinary tract
* Has had previous disease or surgery in lower urinary tract
* Has any MR-scanning contraindication - according to "MR check list"