cyrilzakka/clinical-trials huggingface dataset:
Genomic Structural Variation in Cancer Susceptibility

This study will look for new types of gene changes that may be related to cancer in some patients. Some gene changes (mutations) are passed on from parents to offspring (child). Other gene changes are new and are seen for the first time in a child. They are not seen in the parent.

Some of these gene changes may cause cancers in the offspring. We will look for gene changes by studying patients with cancer their parents and family members without cancer. In this study, we will be able to find gene changes that occur in the cancer patient but not in the rest of the family. Knowing the role that new gene changes play in cancer risk may help us find people at a higher risk of getting cancer.


Eligibility Criteria:
Inclusion Criteria:

* Proband must have living unaffected biologic mother and father available and eligible for participation in the study with one of the following (both incident and prevalent cases will be collected):

  * Colorectal cancer diagnosed at or under the age of 50.
  * Breast cancer diagnosed at or under the age of 45.
  * Germ cell tumor diagnosed at or under the age of 40.
  * Pediatric cancer of any type diagnosed at or under the age of 21
  * Adult cancer or pre-neoplastic condition of any type diagnosed at or under the age of 40
  * Cancer at any age in 2 or more siblings suggestive of a genetic etiology, such as brothers with testicular germ cell tumor or sisters with breast cancer and ovarian cancer
* Parents:

  * Must be the biologic mother and biologic father of affected proband.
  * Must have (by self-report) no history of cancer other than non-melanomatous skin cancer or cervical cancer in situ except in the case of inclusion criteria #6..
  * In certain clinical situations, parent(s) with cancer may be included at the discretion of the Principal Investigator, if the Principal Investigator deems that the etiology of cancer in the parent(s) and proband are biologically unrelated.
* Sibling(s):

  * Must be age 18 or older and have same biologic parents as proband.

Exclusion Criteria:

* Known genetic mutation in proband or a family history that is indicative of hereditary cancer susceptibility.
A Study to Evaluate the Effect of Lorcaserin Hydrochloride on Smoking Cessation

In smokers who are motivated to stop smoking, treatment with lorcaserin compared with placebo will provide greater abstinence as measured by the last 4 weeks of treatment (Weeks 9-12). The target quit date was Day 15.


Eligibility Criteria:
Inclusion Criteria:

1. Males or females aged 18-65 years, inclusive
2. ≥10 cigarettes per day with no period of abstinence longer than 3 months in the past year and who are motivated to quit smoking
3. Able to give signed informed consent
4. Eligible female patients will be:

   1. non-pregnant
   2. non-lactating
   3. agree to use an acceptable method of effective contraception during the study
5. Eligible male patients agree to use contraception when sexually active with a female partner who is not using an acceptable method of birth control
6. Body weight of ≥50 kg (110 pounds), inclusive
7. Considered to be in stable health in the opinion of the investigator

Exclusion Criteria:

Patients who meet any of the following criteria will be excluded from the study.

1. Prior or current use of lorcaserin HCl
2. Prior participation in any study of a nicotine vaccination
3. Use of other therapies for smoking cessation is not allowed within 3 months of screening through study exit
4. Use of tobacco products other than cigarettes
5. Prior use of fenfluramine or dexfenfluramine
6. Serious or unstable medical condition or clinically significant new illness within the 6 months prior to screening
7. Previous participation in any clinical study within 6 weeks prior to the screening visit
8. History of severe allergies, severe drug or excipient allergy or hypersensitivity
9. History of significant cardiovascular condition
10. History of other significant medical conditions
11. Significant risk of suicide
12. Anticipated use of any agents that are associated with valvulopathy and/or pulmonary hypertension
13. Positive test result for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
14. Recent history of alcohol or drug/solvent abuse
15. Concurrent participation in the study by more than one member of the same household
16. Not suitable to participate in the study in the opinion of the investigator
Dual Point PET Scan in Early Stage Hodgkin Lymphoma Patients With Bulky Lesions

To assess specificity and overall accuracy of interim dual-point acquisition PET in predicting treatment outcome.

The study is aimed at assessing the specificity of interim dual-point PET performed after 2 ABVD cycles to predict treatment outcome in early-stage Hodgkin's Lymphoma patients presenting bulky lesions at baseline.

The proposed study is an non-interventional survey of a cohort of patients in whom interim PET scan is performed only for prognostic aims.

PET with 18F-FDG is a standard staging procedure for most lymphoma subtypes. Performed early during the therapy for Hodgkin's lymphoma (HL) its results have a high prognostic value and is the main predictor of treatment outcome. From 2006 onward, interim-PET after 2 ABVD courses has been increasingly performed in the daily clinical practice as a routine test for disease prognosis, and now it can be considered as a standard prognostic tool.

The novelty of the study relies on a new method for interim-PET scan execution: a dynamic study, with 2 different time points of image acquisition. This could potentially enable us to discriminate between unspecific, inflammatory DG uptake, from a "true" uptake form persisting viable neoplastic cells. Therefore, the main aim of the study is reducing false positive results in the interim-PET scan interpretation. Since dynamic changes of FDG uptake in Hodgkin's lymphoma are still unknown we propose, in the present study, to assess the by the same acquisition technique the pattern of FDG uptake at baseline in untreated patients affected by this neoplasm.

The Institutions equipped with a Magnetic Resonance scanners and a diffusion weighted imaging analysis technique (DW-MRI), could participate to the DW-MRI sub-study.

Eligibility Criteria:
Inclusion Criteria:

* Hodgkin lymphoma diagnosis according all the WHO classification subtype but lymphocyte predominance.
* Age 18 - 60 years old
* stage IA- IIA (by FDG-PET scan)
* Presence of bulky tumour (either in Mediastinum or other site)
* Treatment with ABVD x 4 (early stage)
* Consolidation Radiotherapy on bulky lesion
* Signed the Informed consent form

Exclusion Criteria:

* Diabetes mellitus uncompensated
* Lymphocyte predominance histology
* Pregnancy or lactation
* Implanted biomedical devices (for DW-MRI sub study)
PD-1 Combined With Pyrotinib for Chemotherapy Failure HER2 Insertion Mutation Advanced NSCLC

The purpose of this study is to assess the safety and effectiveness of PD-1 Combined With Pyrotinib for First-line chemotherapy failed HER2 Insertion Mutation Positive Advanced Non-small Cell Lung Cancer


Eligibility Criteria:
Inclusion Criteria:

* Advanced non-small cell lung cancer confirmed by histology or cytology
* HER2 insertion mutation-positive
* Failure with first-line standard chemotherapy
* with measurable lesions.

Exclusion Criteria:

* no measurable tumor lesions
* Patients received PD-1 or Pyrotinib before
Monitoring After Cardiac Arrest: Electroencephalogram and Cerebral Oximetry in Predicting Outcome

Because of its high incidence, it is essential to determine the neurological prognosis after cardiac arrest. However, there is not much information to guide post-cardiac arrest care. Also, dynamic monitoring of the state of the brain can help provide information about the patient's prognosis other than previously described serum biomarkers. Therefore, the researchers will monitor postcardiac arrest patients in the intensive care unit for 48 hours by electroencephalogram and cerebral oximetry and collect blood samples for serum biomarkers: neuron-specific enolase (NSE), human neurogranin (NRGN) and human trigger receptor expressed on myeloid cells (TREM-2), which are associated with neuronal damage. And investigate the relation of these data to mortality.

After cardiac resuscitation and intubation, the patient will be followed up with electroencephalogram-based monitoring and cerebral oximetry in the ICU for 48 hours. As standard, post-CPR patients will be sedated with midazolam (0.02- 0.1 mg/kg/s) and remifentanil (0.25- 0.5 mcq/kg/min) for 24 hours.

Brain function measurements will be recorded under sedation for the first 24 hours and without sedation for the second 24 hours. The values recorded were suppression ratio, suppression time, patient state index, oxyhemoglobin and deoxyhemoglobin, and regional oxygen saturation. After 24 hours, a 2 ml blood sample will be taken for biomarkers (NSE, NRGN, TREM-2). Patient survival will be followed up for seven days and 28 days.

The demographic data of the patients (age, gender, body mass index, ASA scores, comorbidities, history of previous operations), blood pressure, heart rate and SpO2, CPR duration, the reason for arrest(4H/4T), and inotropic-vasopressor support before and after arrest will be recorded; GCS, APACHE-2, and SOFA scores will be recorded when the patient is first admitted to the intensive care unit and at the time of cardiac arrest.

Eligibility Criteria:
Inclusion Criteria:

* experienced cardiac arrest
* permanent spontaneous circulation is maintained for at least 48 hours after CPR
* immediate intensive care follow-up after cardiac resuscitation

Exclusion Criteria:

* • Patients under 18 years of age

  * Presence of previously known neurological disease (cerebral palsy, neurodegenerative disease, encephalitis, etc.)
  * Immunosuppressive patients due to previously known hematological malignancy or solid tumor
  * Patients with a history of head trauma
  * Patients with cardiac arrest within 48 hours after spontaneous circulation is established
  * Patients sedated for more than 24 hours
The Health of Women Study

The HOW Study is a first-of-its-kind international online study for women and men with and without a history of breast cancer. The investigators will collect information about your health, your job, your diet, and your family history, among other topics that can help us get a better understanding of breast cancer and its potential causes. Periodically, the investigators will send you questionnaires about anything and everything. All you have to do is fill them out online. It's that simple. This is a partnership and the investigators need you for the long haul. The more questionnaires you fill out, the more information the investigators will have that can help us have a better understanding of why women get breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Men
* Women
* 18 years and older

Exclusion Criteria:

* Under the age of 18
Evaluate the Safety and Efficacy of Dura Sealant Patch in Reducing CSF Leakage Following Elective Cranial Surgery

The objective of the study is to clinically assess the safety and effectiveness of LIQOSEAL® as a means of reducing intra- as well as post-operative CSF leakage in patients undergoing elective cranial intradural surgery with a dural closure procedure to show noninferiority compared to a control group.


Eligibility Criteria:
Inclusion Criteria:

pre-operative

1. Subjects who are able to provide written informed consent prior to participating in the clinical investigation.
2. Subjects who are ≥ 18 years old.
3. Subjects who are able to comply with the follow-up or other study requirements.
4. Subjects wo are planned for elective surgery including a trepanation to reach the subdural infratentorial space (with lower limit of incision defined as the lower edge of C2) in whom a dural incision will be closed.
5. Female subjects of child bearing potential must agree to use a form of contraception from the time of signing the informed consent form through 90 days post-surgery.

intra-operative

1. Subjects with surgical wound classification Class I/Clean.
2. Subjects with minimally 5 mm of dural space surrounding dural opening.

Exclusion Criteria:

pre-operative

1. Female subjects who are pregnant or breastfeeding.
2. Subjects with an assumed impaired coagulation due to medication or otherwise.
3. Subjects suspected of an infection requiring antibiotics.
4. Subjects with any type of dural diseases in planned dural closure area.
5. Subjects requiring re-opening of planned surgical area within 90 days after surgery.
6. Subjects with a known allergy to any of the components (Lactide-Caprolactone co-polyester; Butanediol-BDI co-polyurethane; Polyethylene glycol Succinimidyl Gluterate; Disodium hydrogen phosphate or D\&C Green No 6) of LIQOSEAL®.
7. Subjects who previously received a LIQOSEAL®.
8. Subjects who previously participated in this study or any investigational drug or device study within 30 days of screening.
9. Subjects with a presence of hydrocephalus.
10. Subjects with contra-indication to MRI \[cardiac pacemaker or defibrillator, severe claustrophobia, injured by a metallic object that was not removed, cochlear (ear) implants, metallic implants \[e.g. knee replacement\].

intra-operative

1. Subjects in whom elevation of PEEP has a potential detrimental effect.
2. Subjects who will require a CSF drain, electrodes or other devices passing the dural layer or extra to intracranial bypass surgery.
3. Subjects who have primary closure of the dura mater with synthetic, nonautologous or autologous material other than galea.
4. Subjects in whom no intra-operative CSF leakage is present after primary closure of the dura mater with elevation of PEEP.
5. Subjects who after primary closure (including galea, if applicable) of the dura mater have a gap \> 3 mm.
6. Subjects whom dural opening size including 5 mm margin exceeds patch size (8 x 8 cm).
Extension Study to Evaluate the Long-Term Safety and Tolerability of MBX 2109 in Patients With Hypoparathyroidism

The purpose of this study is to evaluate the long-term safety and tolerability of MBX 2109 in patients with hypoparathyroidism who completed the 12-week treatment period in the Phase 2 study, MBX-2H1002.

This study is to investigate the long-term safety and tolerability of MBX 2109 administered once weekly to patients with hypoparathyroidism. Additionally, the ability of MBX 2109 to maintain serum calcium levels within the normal range without the need for active vitamin D and to reduce elemental calcium supplements to ≤600 mg/day.

Eligibility Criteria:
Key Inclusion Criteria:

1. Must have completed the Week 12 Visit in MBX-2H1002 Study.
2. Is an adult ≥18 years of age at the time of the Screening visit of this extension study.
3. Has a diagnosis of one of the following types of hypoparathyroidism for at least 26 weeks prior to the

   Screening visit:
   1. Postsurgical chronic hypoparathyroidism
   2. Idiopathic hypoparathyroidism
   3. Autoimmune hypoparathyroidism
4. Can comprehend and is willing to sign an informed consent form (ICF), and abide by the study restrictions, study visits, and procedures.
5. In the opinion of the investigator, must be able to successfully demonstrate reconstitution and self-administration of study drug.
The Postoperative Analgesic Effect of Combination With Dexmedetomidine in Fentanyl-based Intravenous Patient Controlled Analgesia Compared With Conventional Thoracic Epidural and Intravenous Patient Controlled Analgesia After Radical Open Gastrectomy

The aim of this study to test hypothesis that addition of dexmedetomidine to fentanyl based intravenous patient controlled analgesia (PCA) improves postoperative pain compared with conventional thoracic epidural and intravenous patient controlled analgesia after radical open gastrectomy.


Eligibility Criteria:
Inclusion Criteria:

1. ASA class I-II
2. obtaining written informed consent from the parents
3. aged 20-65 years who were undergoing radical open gastrectomy

Exclusion Criteria:

1. abdominal surgery previously
2. patient who refuse the patient controlled analgesia
3. unstable angina or congestive heart failure
4. uncontrolled hypertension (diastolic bp\>110mmHg)
5. coagulopathy
6. hepatic failure
7. renal failure
8. bradycardia on EKG (under 50 bpm)
9. Ventricular conduction abnormality
10. drug hyperactivity
11. neurological or psychiatric illnesses
12. mental retardation
13. patients who can't read the consent form due to illiterate or foreigner 14.infection

15. pregnant 16. obesity (BMI \> 30kg/m2)
Detecting the Most Efficient Residency Time for Laparoscopic Simulators

Laparoscopic surgeries is one of the most common surgery in gynecologic procedures. Nowadays there are many laparoscopic simulators for training residents. In this study it is aimed to determine the most efficient residency year for laparoscopic simulators.

This study planned as a prospective study. There will be three group which include ob/gyn residents. The residents will choose based on their residency year and surgery skills. 1. The residents who makes surgeries both laparoscopic and laparotomic, 2. The residents who makes surgeries only laparotomic, 3. The residents who won't any gynecologic surgery The data of surgery time, complications and movement numbers will take from the simulator. Tubal ligation and salpingooferectomy choose for the surgery examples. The simulation results of participants will compare and try to find the best improvement term for residency.


Eligibility Criteria:
Inclusion Criteria:

* Should be an ob/gyn resident
* Should except to participate study

Exclusion Criteria:

* Not to complete all simulations
Impact of Cerebellar Mass Resection on Pain Processing

The purpose of the study is to evaluate how cerebellar resection surgery may affect pain sensation and the way the brain "reads" pain signals. By measuring brain activity in children and adolescents following surgery, the investigators hope to gain valuable information about pain processing in the brain.

This study is designed to test whether cerebellar resection surgery affects pain pathways in the brain. To participate a participant must (A) have had a cerebellar mass surgically removed, or (B) are a healthy volunteer with no history of pain disorders or mental illness. The study will involve sensory testing and brain imaging using magnetic resonance imaging (MRI) Sensory testing will be performed using a tub of cold water, as well as a contact thermode capable of delivering hot and cold temperatures. MRI brain scanning uses magnetic fields and radio waves to give pictures of the brain without using radiation.

Eligibility Criteria:
Inclusion Criteria for patients:

* Age 4-18 years old at the time of surgery
* Resection limited to the cerebellum
* Within 20 years of surgery
* Good physical health excluding symptoms directly related to cerebellar resection
* No cerebellar-mass directed treatment other than surgical resection

Inclusion Criteria for all subjects:

* Age 6-38 years old at the time of participation
* No paralysis/hemiparesis
* No motor deficits that would interfere with performance or required tasks (button press withdraw hand from water bath)
* English speaking sufficient to comprehend and provide assent with parental assistance or consent if over the age of 18
* Ability to complete MRI without sedation

Exclusion Criteria:

* Claustrophobia
* Significant medical (e.g. asthma, renal, cardiac, gastrointestinal or immunological) or brain- related disorders (e.g. seizures, autism, psychiatric conditions such as severe depression, psychosis)
* Metallic or magnetic implants that pose a risk to the participant or to the data quality
* Weight \> 285 pounds (weight limit of the fMRI table)
* History of drug abuse or positive drug screen
* Positive pregnancy screen
* Use of antidepressants or anticonvulsants, excepting patient usage after resection
* Significant alcohol history (ingestion of 5 or more glasses (\> 40 oz) of alcohol per week)
* Tattoos containing metallic ink on the neck, shoulders, upper arm and head (which could heat up in the scanner, and potentially cause blistering or burning)
* Cardiac pacemakers
* Aneurysm clips and other vascular stents, filters, clips or other devices
* Prosthetic heart valves
* Other prostheses
* Neuro-stimulator devices
* Implanted infusion pumps
* Cochlear (ear) implants
* Ocular (eye) implants or known metal fragments in eyes
* Exposure to shrapnel or metal filings (sheet metal workers, welders, and others)
* Participants that require anesthesia to complete an MRI scan
* Receipt of a medication via transdermal patch
Burch Colposuspension and Mid-urethral Sling Operations

Stress urinary incontinence is common in women. the treatment of this condition is surgery. investigators add stress incontinence surgery to patients who undergo total laparoscopic hysterectomy for benign reasons.

Depending on the patient's general condition and indications, the operation can be performed by vaginal approach, as well as mid-urethral sling operations and laparoscopic burch colposuspension.

The researchers aimed to compare these two types of operations performed on patients. In this way, the superiority and disadvantage of each other in two procedures will be demonstrated.


Eligibility Criteria:
Inclusion Criteria:

* A total laparoscopic hysterectomy was planned for benign causes,
* Patients scheduled for simultaneous operation for incontinence

Exclusion Criteria:

* Patients previously operated for urinary incontinence
* Patients whose diagnosis of stress urinary incontinence is uncertain
* Patients with urinary tract infection
Regional Observatory on Metabolic Syndrome- LAZIO

The aim of the study, is to assess the prevalence of Metabolic Syndrome in Italy on a regional basis, defined according to NCEP/ATPIII Guidelines criteria.


Eligibility Criteria:
Inclusion Criteria:

* lipid profile in the last year
* Signed informed consent

Exclusion Criteria:

* Subjects with serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's successful participation in the study
* Pregnancy or breast feeding
* Subject who are unwilling or unable to provide the informed consent
The Influence of Sedation and General Anesthesia to Patients' Psycho-emotional State Undergoing Wisdom Teeth Extraction

The aim of the study is to evaluate, wheather the sedation or general anesthesia in third molar extractions influence the patient's psycho-emotional status. It is believed that the type of anesthesia may influence not only the psycho-emotional status after the procedure, but also before the procedure.

A prospective pilot study was conducted on adult patients who were admitted to the Faculty of Surgery at LSMU KK hospital for removal of all four wisdom teeth with sedation or general anesthesia. The patients were given one day to complete the given questionnaires. They were asked to complete three questionnaires: a) before the surgery, i.e. at the time the patient was hospitalized; b) the same day prior to surgery; c) ten days after the surgery. The operating doctor also filled out a questionnaire ten days after the surgery.

The aim of the study is to evaluate, wheather the sedation or general anesthesia in third molar extractions influence the patient's psycho-emotional status. It is believed that the type of anesthesia may influence not only the psycho-emotional status after the procedure, but also before the procedure.

Eligibility Criteria:
Inclusion Criteria:

* Patient age ≥ 18 years;
* Indicated removal of all 4 wisdom teeth;
* Non-use of NSAIDs, anticoagulants;
* No acute inflammation in the operated area;
* No history of common conditions that contraindicate oral surgery. For example, uncontrolled diabetes, cardiovascular disease;
* Patients agreed to participate in the study.

Exclusion Criteria:

* Pregnant, breastfeeding women;
* Individuals, formerly treated with radiation;
* Patients who participated in studies related to the assessment of psycho-emotional status;
* Patients with obvious mental, intellectual or physical disabilities limiting the participation in the study.