cyrilzakka/clinical-trials huggingface dataset:
Genetic Testing in Autosomal Dominant Polycystic Kidney Disease

Individuals with a diagnosis of autosomal dominant polycystic kidney disease (ADPKD) often have a family history of the condition although up to 10-15% of cases are sporadic mutations. The investigators recently conducted an analysis of the investigators clinic population to determine percentages of individuals who have undergone kidney imaging and genetic testing and determined total numbers of patients eligible for tolvaptan and those currently active on tolvaptan. The study team found large racial discrepancies in usage of tolvaptan and found that more patients are eligible for tolvaptan than are currently taking the medication. Reasons for this are often due to patient perception about the medication rather than treatment failure. There is a strong medical need to understand reasons for underuse of this critical medication in this population. Among those with genetic testing, the study team found large disparities in ethnic background between individuals offered genetic testing who accept versus decline testing. The study team also found that those who choose to pursue genetic testing are more likely to have no family history of the condition, presumably because the diagnosis is more "surprising" to them and thus desire for verification by genetic testing, if possible, is greater. However, it is known that genetic testing can be an important component of understanding of disease biology in all patients with ADPKD, while also providing important clinical information in some cases as individuals prepare for living donor transplantation or family planning. The investigators seek to understand barriers to use of tolvaptan and genetic testing among individuals in the clinic population and their relatives across a wide range of racial and ethnic backgrounds. The investigators hypothesize that anxiety about genetic conditions in particular is a barrier to accepting testing. The investigators seek to understand the mental health aspects of the diagnosis of ADPKD. They will also evaluate changes in symptoms compared to pre-treatment after initiation of tolvaptan in eligible individuals using qualitative techniques. In so doing, the study team hope to improve care for current patients and also to expand the pool of the clinic population to include newly diagnosed family members ideally at early stages of disease.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of ADPKD

Exclusion Criteria:

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Study of ATI-1777 in Patients 12 to 65 Years Old With Mild to Severe Atopic Dermatitis

This is a Phase 2b study to determine the safety, tolerability, pharmacokinetic (PK), and efficacy of ATI-1777 in patients 12 to 65 years old with mild to severe Atopic Dermatitis. Eligible participants will apply either ATI-1777 or Vehicle Topical Solution once daily or twice daily for 4 weeks.


Eligibility Criteria:
Inclusion Criteria:

1. Able to comprehend and willing to sign the IRB approved ICF/assent prior to administration of study-related procedures.
2. Male patients or non-pregnant, non-nursing female patients 12 to 65 years old, inclusive, at the time of informed consent/assent.
3. Have at least a 6-month history of AD prior to the Screening Visit, and no significant AD flares for the 4 weeks prior to the Screening Visit.

Exclusion Criteria:

1. Unstable course of AD (spontaneously improving or rapidly deteriorating) based on the patient history or as determined by the investigator during the Screening Period.
2. Concomitant skin disease or clinically infected AD or presence of other skin disease in the area to be dosed that may interfere with study assessments.
3. Female patients who are pregnant, nursing, or planning to become pregnant during the study.
Feasibility Study for PANDAS

We have been asked to participate in the Pediatric Anesthesia NeuroDevelopmental Assessment Study (PANDAS), which is a study to compare neurocognitive functions in sibling pairs: one of whom had exposure to anesthesia during inguinal hernia surgery before three years of age (exposed) and the other who was not exposed to anesthesia or surgery in the first three years of life (unexposed). A consortium of approximately 6 hospitals is doing this feasibility study to determine if there is an adequate number of subjects for each of the two age groups before the formal study begins.

Feasibility study to obtain information through a telephone interview with parents of eligible children Once we identify the children who were less than one year of age and those between the ages of 1 and 3 that who had inguinal hernia surgery during the years of 1999-2007, we will call the parents to determine if the index patients have siblings. If so, we would also ask if there is a sibling within 3 years of the index patient's age and if they have had no exposure to anesthetics or sedatives before their third birthday. Exclusion criteria for both index patients and siblings would include gestational age at birth of \< 36 weeks, any history of hospitalization, including neonatal ICU, a history of CNS, cardiac, or pulmonary diseases requiring medical treatment, or a history of subsequent surgery or exposure of anesthetics or sedatives.

Eligibility Criteria:
Inclusion Criteria:

1. Males or females age 0 to 1 year.
2. Inguinal hernia surgery between 1/1/1999 and 12/31/2007.
3. Parental/guardian permission (informed consent).

Exclusion Criteria:

1. Gestational age \< 36 weeks.
2. Any history of hospitalization, including neonatal ICU.
3. A history of CNS, cardiac, or pulmonary diseases requiring medical treatment.
4. History of subsequent surgery or exposure to anesthetics or sedatives at less than 3 years of age.

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Only Mesh Fixation With Glue of Ventral/Incisional Laparoscopic Hernia Repair

This multicenter randomized controlled non-inferiority trial of only mesh fixation with a glue applicator is a trial to evaluate the outcomes between atraumatic laparoscopic mesh fixation with GLUTACK-Glubran2® and conventional traumatic fixation, so the primary endpoint of the study is to analyze the recurrence on ventral or incisional hernia repair 2 years postoperatively assessed by a clinical and/or imaging technique.

Patients older than 18 years undergoing an elective ventral/incisional hernia laparoscopic repair with a hernia defect between 4-10cm of transversal defect The patients included are adults with a BMI lesser than 35 Kg/m2 undergoing an elective laparoscopic primary ventral or incisional hernia repair with a fascial transverse defect between 4-8 cm (W2 EHS) on anterior or lateral location (M1-M5 up to 10 cm of length or L1-3) For the interventional procedure, three ports are used (1x11 mm and 2x5 mm) and after adhesiolysis and the field prepared, the defect is measured with a local standard in a craneo-caudal and transversal directions. Then, the defect is closed with a 2-0 caliber barbed suture following its biggest axis. A Dynamesh IPOM previously hydrated (2-3 min) is introduced throughout the 11mm trocar and extended. After this maneuver, mesh fixation is performed depending on the randomized arm (125 per arm): either traumatic fixation with the conventional procedure and device or with Glutack-Glubran®2.

After two years of follow-up, the recurrence will be analyzed.

Eligibility Criteria:
Inclusion Criteria:

* All adults with a BMI lesser than 35 Kg/m2 undergoing an elective laparoscopic primary ventral or incisional hernia repair with a fascial transverse defect between 4-8 cm (W2 EHS) on anterior or lateral location (M1-M5 up to 10 cm of length or L1-3)
* ASA grade from I-II
* Informed consent signed

Exclusion Criteria:

* Patients less than 18 years and over 80 years of age.
* Fascial transverse defect less than 4 cm and more than 8 cm.
* Recurrent ventral or incisional hernia in the same place
* Emergency surgery
* Procedure involving concomitant surgeries (e.g. gastrointestinal, biliary or genitourinary surgery)
* BMI greater than 35 Kg/m2
* ASA III-IV
* Pregnancy
* Tobacco
Dose-Finding Study of Intranasal Insulin in Healthy Participants Insulin in Healthy Participants

This study is to determine the safety and tolerability of regular insulin (Humulin R) when given intranasally (as drops in nostrils).

Healthy participants will be enrolled to determine the maximum tolerated dose of intranasal insulin.

This is being studied because intranasal insulin may be a way to prevent the brain injury that occurs after a cardiac arrest. Cardiac arrest is a life-threatening condition in which the heart suddenly stops beating and there is no blood flow to the body. If cardiac arrest is not treated immediately, it causes sudden death. Even when immediate treatment gets the heart beating again, many victims remain comatose and die later from brain injury. Nasal insulin, given immediately after a cardiac arrest may prevent or reduce brain injury. Nasal insulin reduces brain injury in animal experiments, and has been used to try to improve brain degeneration in patients with Alzheimer's disease. However, cardiac arrest patients may need higher doses than patients with Alzheimer's disease, therefore, this study is to examine those higher doses.

Eligibility Criteria:
Inclusion Criteria:

* Good health based on medical history, physical exam, and routine laboratory testing.
* Female participants must have negative urine pregnancy test or be surgically sterilized or postmenopausal. Criteria for menopause are surgical menopause (hysterectomy, oophorectomy) or age \> 45 years with the absence of menses for greater than 12 months. Tubal ligation with menses within the past 12 months is not considered to be surgical sterilization.
* Body mass index (BMI) between 18 kilogram / square meter (kg/m2) and 35 kg/m2.
* Willing and able to stay at the clinical research facility as required by the protocol
* Willing and able to comply with the investigational nature of the study and able to communicate well with investigators
* Ability to comprehend and willing to provide written informed consent in accordance with institutional and regulatory guidelines

Exclusion Criteria:

* Known allergy to insulin.
* Preexisting diabetes.
* Current or previous use of diabetes medication or insulin.
* Any nasal disease or congestion that may interfere with intranasal drug absorption.
* Baseline hypoglycemia (blood glucose ≤ 65 mg/dL) or hyperglycemia (blood glucose \> 200 mg/dL) as evident from the screening labs.
* Active serious disease, such as liver disease, kidney disease, uncontrolled hypertension, clinically significant hypokalemia, and significant or unstable medical illness
* Blood donation in excess of 500 milliliter (mL) within 60 days prior to the first dose of study medication.
* Treated with an investigational drug within 30 days.
* Individuals with inadequate venous access.
LymphoPilot Test for Limb Lymphedema

The present study is a first-in-man, single arm, open-label, single center study to assess feasibility and safety of a novel implantable device, LymphoPilot, in patients suffering from secondary upper limb or lower lymphedema.

The study consists in a first-in-man clinical investigation for LymphoPilot, an investigational implantable medical device. LymphoPilot is composed of an implanted part and an external wearable device. The implanted part (pump, drainage catheter and output catheter), is implanted in the subcutaneous tissue of the arm or leg and drains excess fluids to the supraclavicular or abdominal subcutaneous tissue, where fluids are naturally reabsorbed by the healthy lymphatic and venous system. The external part consists in a wearable controller used to activate the implanted pump.

The subcutaneous implantation of the device is performed in loco-regional or general anesthesia, in ambulatorial settings, and the patient is dismissed from the hospital on the same day of the procedure.

The device is activated in the postoperative room by placing the external wearable device on patient's limb, in proximity of the implanted pump. Patients are required to wear the external controller continuously throughout the study, except 30 minutes per day, to allow taking a shower/bath.

Follow-up visits are planned 1, 4 and 8 weeks after device implantation. The implanted device is removed with a surgical procedure in local anesthesia 8 weeks after device implantation, and 2 additional follow-up visits are planned after device removal.

Eligibility Criteria:
Inclusion Criteria:

* Female patients, 18 years and older
* Patients with unilateral secondary upper or lower limb lymphedema.

Exclusion Criteria:

* Active cellulitis/infection
* Lymphedema associated with active cancer requiring chemotherapy or radiotherapy
* Motor and sensitive neurological deficiency
* Post-operative edema (i.e. acute edema following breast cancer related surgery)
* Any contraindication to surgery or to loco-regional or general anesthesia
* Patient participating in any other clinical study
* Patient unable to provide informed consent
* Patient with pacemaker
* Pathologies associated with an overload of the cardiac system
* Poor wound healing
* Pregnancy or breastfeeding
* Known intolerance to implantable devices
* Known allergies to silicone
* Patient needing magnetic therapy
* Any other condition that according to the principal investigator makes the patient unsuitable for the participation in the trial
* Patient refusing to receive information about incidental findings on her health status discovered during the clinical investigation
* L-Dex score lower than 6.5 at screening
Use of Arterio-venous Fistula as First Choice for Intravenous Drug Administration in Kidney Transplant Recipients

Use of arteriovenous fistula for IV drug administration is controversial and often prohibited by nephrologists. However, we have been using this method in our department for years now in order to keep the patients 'veins for other fistulas in the future. The aim of this study is to evaluate our practice and maybe provide a justification for a larger multi-center study given the importance of this subject in patients with chronic renal failure.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years, functional AV fistula, new kidney transplant recipient

Exclusion Criteria:

* Prothetic AV fistula, Very recent AV fistula of less than 3 months
Sleep, Blood Pressure and Vascular Health

The investigators hypothesize that chronic insufficient sleep is associated with diminished endothelium-dependent nitric oxide-mediated vasodilation and endothelial tissue-type plasminogen activator release in adults with elevated blood pressure. Furthermore, the investigators hypothesize that the postulated diminishment in endothelial vasodilator and fibrinolytic function with insufficient sleep will be due, at least in part, to increased oxidative stress. Furthermore, increasing sleep duration and improving sleep quality will increase both endothelium-dependent nitric oxide-mediated vasodilation and endothelial tissue-type plasminogen activator release in adults with elevated blood pressure. Increases in endothelial vasodilator and fibrinolytic function will be due, at least in part, to reduced oxidative stress.


Eligibility Criteria:
Inclusion Criteria:

Subjects will be men and women of all races and ethnic backgrounds aged 45-65 years.

All women will be premenopausal, perimenopausal or post-menopausal not taking hormone replacement therapy.

Subjects will be prehypertensive/hypertensive (Stage 1 hypertension) defined as resting systolic blood pressure 125-159 mmHg and/or diastolic blood pressure 75-99 mmHg.

Subjects will have no overt signs of disease as assessed by:

1. medical history;
2. physical examination;
3. electrocardiogram and BP at rest and maximal exercise;
4. sedentary as determined from the Stanford Physical Activity Questionnaire (\<35 kcal/wk) and will not have engaged in any program of regular physical activity for at least 6 months prior to the study.
5. Subjects that have a pre-existing diagnosis of obstructive sleep apnea, or are determined to have obstructive sleep apnea based on their sleep disorders screening visit will be allowed in the study, but will not take part in the sleep intervention/post sleep intervention visits.

Exclusion Criteria:

History of stroke (phone screen and medical record) Peripheral vascular disease (phone screen and medical record) History of anaphylaxis to betadine, lidocaine, iodine Body mass index \> 40 kg/m2

Subjects taking blood pressure-or diabetes related medication Chronic Insomnia (prior or current diagnosis) History of or current psychiatric disorder (e.g., prior or current diagnosis, current BDI-II\>13; BAI\>10) Significant organ system dysfunction/disease (e.g. diabetes, severe pulmonary, kidney disease) History of seizure disorder Pregnant/nursing Positive toxicology screen-(THC, OPI, AMP, COC, PCP, BAR, BZO, MAMP/MDMA upon sleep lab admission)
Metacognition in Neurological Injury

The purpose of this study is to investigate the trajectory of metacognitive functioning throughout phases of recovery from neurological insult, and to determine its relationship to rehabilitation compliance and functional outcome. It is hypothesized that metacognitive accuracy improves over time, and is a significant predictor of engagement in rehabilitation activities.

This study will examine the trajectory of metacognitive functioning through different phases of recovery from neurological insult, and document its relationship to rehabilitation compliance. Individuals currently completing rehabilitation programs and individuals from the community who meet study criteria are invited to participate. After consenting and enrolling in the study, participants complete 2 study sessions: a baseline session, and a follow-up session either at time of completion of rehabilitation program or 3 months later if not in a rehabilitation program. During the study sessions, participants will complete paper-and-pencil and computerized tests of cognition (including metacognitive tasks).

Eligibility Criteria:
Inclusion Criteria:

* history of brain and/or spinal cord injury
* no history of brain or neurological injury/insult (for healthy control group)
* fluent in spoken and written English
* adequate gross motor abilities to provide a button push on a keyboard

Exclusion Criteria:

* exclusion criteria for healthy controls include:
* current/past history of psychiatric illness
* learning disorder
* developmental disorder
* diagnosis of Attention Deficit Disorder/Attention Deficit Hyperactive Disorder
PROPOSE Quality - PReOtact in Postmenopausal OStEoporosis - Quality of Life Study (FP-004-DE)

The objectives of the study are

* to describe the quality of life at the beginning of the Preotact® treatment and at the end of the observational period (Qualeffo-41 questionnaire)
* pain assessment at the beginning of the Preotact® treatment and at the end of the observational period (VAS score)
* to describe bone mineral density at the beginning of the Preotact® treatment and at the end of the observational period (T-Score)
* to describe incidence of bone fractures caused by osteoporosis as well as of other pathological findings of the skeleton after the beginning of the Preotact® treatment
* to describe serum level of calcium and the bone resorption marker desoxypyridinoline (DPD) and N- respectively C-terminal crosslink-telopeptide (CTX and NTX) at the beginning of the Preotact® treatment and at the end of the observational period (only in subgroup of patients, where the physician sees a need to measure these parameters)
* to document all adverse drug reactions after the beginning of the Preotact® treatment
* the analysis of subgroups with different risk for bone fractures caused by osteoporosis at the beginning of the Preotact® treatment
* to assess the manageability and functioning of the Pen system for injection of Preotact® (self administered questionnaire)


Eligibility Criteria:
Inclusion Criteria:

* Inclusion requires that Preotact® is prescribed in accordance with the SPC and that the stated contraindications are strictly considered.
* Caution should be taken by the treating Physician concerning any precautions, warnings and potential drug interactions stated in the SPC.
* No further inclusion or exclusion parameters are defined. The decision for the individual application of Preotact® will be strictly made by the physicians.
Tumor Molecular Profiling in Patients With Prostate Cancer

The aim of the study was to evaluate the prevalence, the prognostic and predictive value of gene alterations in unselected patients with prostate cancer. Patients with histologically confirmed prostate cancer, treated at Hellenic Cooperative Oncology Group (HeCOG)-affiliated departments, were included. The presence of gene alterations was assessed using the ForeSENTIA® Prostate panel developed by NIPD Genetic.

Data on tumor molecular profiling of European patients with prostate cancer is limited. The aim of the study was to evaluate the prevalence, the prognostic and predictive value of gene alterations in unselected patients with prostate cancer. Patients with histologically confirmed prostate cancer, treated at Hellenic Cooperative Oncology Group (HeCOG)-affiliated departments, were included. The presence of gene alterations was assessed using the ForeSENTIA® Prostate panel developed by NIPD Genetic. The primary endpoint was the prevalence of gene alterations in homologous recombination repair (HRR) genes. Secondary endpoint was overall survival.

Eligibility Criteria:
Inclusion Criteria:

Metastatic prostate cancer Recurrent prostate cancer Locally advanced prostate cancer High-risk operable prostate cancer Available FFPE tumor tissue

Exclusion Criteria:

Absence of tumor tissue available for analysis Lack of informed consent Lack of clinicopathological data
Expanded Access of Sotorasib

The primary objective of this study is to provide expanded access to and characterize the safety profile of Sotorasib in participants with previously treated locally advanced/unresectable/metastatic non small-cell lung cancer (NSCLC) with KRAS p.G12C mutation in a real-world setting.


Eligibility Criteria:
Inclusion Criteria

* Age ≥ 18 years
* Ineligibility for participation in any Amgen-sponsored ongoing clinical study of the investigational product
* Pathologically documented, locally-advanced and unresectable or metastatic Non Small-Cell Lung Cancer (NSCLC) with KRAS p.G12C mutation confirmed through molecular testing
* Exhausted other standard of care options for locally advanced and unresectable or metastatic NSCLC disease including platinum-based combination chemotherapy and programmed cell death protein 1/programmed death-ligand 1 (PD 1/PD-L1) immunotherapy (unless medically contraindicated)
* Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2

Exclusion Criteria

* Mixed small-cell lung cancer or mixed NSCLC histology
* Active brain metastases
* Active hepatitis B or hepatitis C virus
* Current active malignancy other than NSCLC
* Currently or previously enrolled in a prior sotorasib study unless radiographic disease progression confirmed, able to remain on long term follow up of their original protocol and receives medical monitor approval
* Female participants planning to become pregnant while on study through 7 days after the last dose of sotorasib