cyrilzakka/clinical-trials huggingface dataset:
Safety and Feasibility of Liver Retraction With the Levita Magnetic Surgical System: Extended Magnetic Grasper Device

The purpose of this study is to evaluate the safety and effectiveness of the Extended Magnetic Grasper Device in patients undergoing bariatric and/or hiatal hernia procedures, as a liver retractor grasping the liver and/or the tissue surrounding the crus of the diaphragm.

The purpose of this study is to evaluate the safety and effectiveness of the Levita Magnetic Surgical System Version 2 in patients undergoing bariatric and/or hiatal hernia procedures.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age.
* Scheduled to undergo elective bariatric and/or hiatal hernia procedures.
* Willing and able to provide a written Informed Consent Form (ICF) to participate in the study prior to any study required procedures.

Exclusion Criteria:

* Individuals with pacemakers, defibrillators, or other electromedical implants.
* Individuals with ferromagnetic implants.
* American Society of Anesthesiologists (ASA) score of III or IV.
* Significant comorbidities: cardiovascular, neuromuscular, chronic obstructive pulmonary disease, and urological disease (renal failure).
* Clinical history of impaired coagulation confirmed by abnormal blood tests.
* Individuals has signs of hepatic abnormality (e.g.: cirrhosis, liver failure, increase in liver enzymes, etc.).
* Anatomical abnormality or disease of intended target tissue noted after initiation of index procedure that would prevent device use.
* Pregnant or wishes to become pregnant during the length of study participation.
* Individual is not likely to comply with the follow-up evaluation schedule.
* Participating in a clinical trial of another investigational drug or device.
* Prisoner or under incarceration.
Endurant Bifurcated and Aorto-Uni-Iliac (AUI) Stent Graft System

To demonstrate safety and effectiveness of the Endurant Stent Graft in the treatment of Abdominal Aortic or Aorto-Uni-Iliac Aneurysms.

Prospective, two-arm, non-randomized, multicenter clinical study enrolling subjects treated with the bifurcated stent graft in one arm and subjects treated with the AUI in a second arm.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is ≥ 18 years old.
2. Subject (or Subject's legal representative) understands and voluntarily has signed and dated an Informed Consent document approved by the Sponsor and by the Institutional Review Board.
3. Subject is able and willing to comply with the protocol and undergo follow-up requirements.
4. Subject is a suitable candidate for elective surgical repair of AAA by as evaluated by American Society of Anesthesiologists (ASA) Physical Status Classification System I, II, III, or IV
5. Subject has an abdominal aortic or aortoiliac aneurysm characteristics that meet protocol parameter
6. Subject meets all the protocol anatomical criteria\* as demonstrated on contrast-enhanced CT or MRA
7. Subject has vascular dimensions in the range of sizes available for the Endurant Stent Graft
8. Subject has documented imaging evidence of at least 1 patent iliac and 1 femoral artery, or can tolerate a vascular conduit that allows introduction of the device.
9. Subject's native vessel anatomy is more suited for the introduction and/ or deployment of an Endurant Uni-Iliac Stent Graft System.

Exclusion Criteria:

1. Subject has a life expectancy \< 1 year
2. Subject is participating in another investigational drug or device study
3. Subject requires emergent aneurysm treatment
4. Subject is a female of childbearing potential in whom pregnancy cannot be excluded.
5. Subject has a known hypersensitivity or contraindication to anticoagulants, antiplatelets, or contrast media, which is not amenable to pre-treatment.
6. Subject is morbidly obese (body mass index ≥ 40 kg/m2) or has other documented clinical conditions that severely inhibit radiographic visualization of the aorta.
Discussion on the Association Model of Traditional Chinese Medi-cine Body Constitution and Female Infertility

Abstract Background: Infertility may cause physiological and psychological distress. The Health Promotion Administration in Taiwan has listed infertility improvement under the "Reproductive health and prevention section" in the Whole Person Wellness policy.

Methods: This study was based on an exploratory research design. It used artificial intelligence algorithms such as logistic regression and association rules, and constructed the association model between the physique literature of traditional Chinese medicine and common demographic variables.

Results: The participants showed three types of constitutions in traditional Chinese medicine, namely Yin deficiency, Yang deficiency, and phlegm stasis. Infertile women who prefer to eat heavy or sour-tasting foods were 2.8 times more likely to have ovarian factors than those who do not like to eat those foods.

Conclusions: Based on the correction between physique type and the demographic variables of infertile women, care based on traditional Chinese medicine should be pro-vided to improve the body constitutions of infertile women.

Abstract Background: Infertility may cause physiological and psychological distress. The Health Promotion Administration in Taiwan has listed infertility improvement under the "Reproductive health and prevention section" in the Whole Person Wellness policy.

Methods: This study was based on an exploratory research design. It used artificial intelligence algorithms such as logistic regression and association rules, and constructed the association model between the physique literature of traditional Chinese medicine and common demographic variables.

Results: The participants showed three types of constitutions in traditional Chinese medicine, namely Yin deficiency, Yang deficiency, and phlegm stasis. Infertile women who prefer to eat heavy or sour-tasting foods were 2.8 times more likely to have ovarian factors than those who do not like to eat those foods.

Conclusions: Based on the correction between physique type and the demographic variables of infertile women, care based on traditional Chinese medicine should be pro-vided to improve the body constitutions of infertile women.

Eligibility Criteria:
Inclusion Criteria:

* Female

Exclusion Criteria:

* male
Real-world Experiences of Alcohol and Cognitions Over Time

The goal of this clinical trial is to examine how alcohol affects young adults' attention in both laboratory and real-world settings through phone-based cognitive tasks. The main questions this trial is designed to answer are:

* How well do the phone-based cognitive tasks capture alcohol's effects on attention?
* Does the effect of alcohol on attention contribute to risk-taking?

Participants will complete cognitive tasks to assess attention before and after consuming a standard amount of alcohol in the laboratory, and during surveys completed through a phone app for eight weekends.

The goal of this study is to develop cognitive tasks that assess alcohol-related attentional narrowing (i.e., alcohol myopia) for smartphone-based ecological momentary assessment (EMA). In Phase I, tasks were adapted from computer to smartphone format and refined through interviews with young adults who provided feedback on mock-ups. In Phase II (the current trial), feasibility, acceptability, reliability, and validity of the adapted tasks will be tested in lab and EMA. Young adults who pass an online pre-screening and phone screening will complete an initial lab session involving self-report questionnaires, alcohol consumption (target breath alcohol concentration \[BrAC\] = .08%), and general cognitive and myopia-specific tasks. All participants in Phase II will be assigned to receive a dose of alcohol in the lab session; task performance will be compared within individuals from before to after they are intoxicated. Participants will remain in the lab until their BrAC reduces to a level of .03% and they can pass a field sobriety test. These same participants will then complete EMA while wearing transdermal alcohol biosensors for 8 consecutive weekends, including one morning survey and at least two evening surveys per day. Then, participants will return to the lab for a follow-up session involving self-report questions and an interview eliciting additional feedback. Findings will help to clarify the role of alcohol myopia as a mechanism linking intoxication to real-world risk behaviors.

Eligibility Criteria:
Inclusion Criteria:

* aged 21-25
* drink at least 2x/week in the past month
* at least 1 past-month heavy episodic drinking event (4+/5+ standard drinks in a day for females/males)
* have an iPhone
* able to read and understand English
* willing to complete all study procedures

Exclusion Criteria:

* history of alcohol-related treatment or hospitalization
* medical contraindications for alcohol consumption (e.g., contraindicated medication, major psychiatric illness, history of seizure, gastric bypass surgery, cardiac pacemaker, major illness such as liver cirrhosis or hepatitis, past traumatic brain injury, asthma exacerbated by alcohol use, consistent flushing response to alcohol use) or pregnancy, nursing an infant, or plans to become pregnant in the next 8 weeks (i.e., during the EMA monitoring period)
* substantial visual impairment or color blindness (given that cognitive tasks rely on visual cues)
Feasibility Study of Anatomical Modeling for Image Guided Thoracic Surgery

This clinical trial assesses the feasibility of creating a 3 dimensional (D) model of the lung and lung nodule(s) from computed tomography (CT) scan images performed during lung surgery. Unlike solid organs (like the kidney, brain, and liver), the lung changes shape (they inflate when a person breathe in and collapse when they breathe out). This makes it difficult to predict where, exactly, the tumor(s) will be on the lungs during surgery. A 3D model may help surgeons better predict where the location of the tumor(s) will be during surgery.

PRIMARY OBJECTIVE:

I. To assess the feasibility of developing an anatomical model to predict the location of the tumor in a deflated lung to assist in guidance during lung surgery.

SECONDARY OBJECTIVES:

I. Develop a registration technique to register the tumor onto the 2D/3D optical image obtained during surgery.

II. Determine the accuracy of mapping major segmental vasculature and bronchial structures onto 2D/3D optical images obtained during surgery.

OUTLINE:

Patients undergo 4 CT scans during standard of care surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have previous CT images demonstrating a lung mass or masses amenable to lung resection (open or minimally invasive)
* Patient is scheduled for surgical resection in a room equipped with intraoperative CT
* Patient must sign informed consent, with risks and benefits of CT imaging explained
* Patients with lung tumors \>= 1cm to =\< 3 cm based on preoperative CT scan. (Patients with lung tumors from \< 1 cm or \> 3 cm will be reviewed and approved for inclusion on an individual assessment by clinical collaborators)

Exclusion Criteria:

* Pediatric patients less than 18 years of age
* Patients who have undergone previous ipsilateral thoracic surgery, sclerotherapy, or radiation therapy as intraoperative adhesions may limit lung collapse intraoperatively
* Patients who received neoadjuvant immunotherapy
* Women who are pregnant or nursing
Assessment of New Molecular Imaging Strategies for Prostate Cancer

In this study 30 men, with advanced metastatic Castration-Resistant Prostate Cancer (CRPC) planned to have hormonal treatment, will undergo conventional imaging and functional imaging prior to treatment and post treatment to determine if changes in imaging results will be prognostic of outcome. Patients will have a clinical follow-up every 3 months post randomization for one year and followed for survival at Years 2 and 3.

In this study 30 men, with advanced metastatic CRPC intended to have abiraterone acetate or enzalutamide hormonal treatment will undergo conventional imaging including a 99mTc-Methyl diphosphonate (MDP) bone scan and Computed Tomography (CT) of the abdomen and pelvis, and functional imaging with 18F-fluorodeoxyglucose (FDG) PET-CT and 2-(3-(1-carboxy-5-\[(6-\[18F\]fluoro-pyridine-3-carbonyl)-amino\]-pentyl)-ureido)-pentanedioic acid (18F-DCFPyL) PET-CT one to four weeks prior to hormonal treatment and approximately 10 weeks post hormonal treatment.

Prostate Specific Antigen (PSA) will also be obtained at baseline and every three months in the first year. Baseline imaging of disease and changes between baseline and follow-up imaging on 18F-FDG PET-CT and 18F-DCFPyL PET-CT will be compared with standard of care imaging (99mTc-MDP bone scan and CT of the abdomen/pelvis) as well as with clinical evaluation including response to therapy and progression of disease.

This information could be used by clinicians to guide androgen receptor (AR) - targeted therapy. Patients will have a clinical follow-up every 3 months post randomization for one year and will be followed for survival at Years 2 and 3.

Eligibility Criteria:
Inclusion Criteria:

1. Objectively documented metastatic prostate cancer progression with either of the following:

   * At least one rising PSA over a minimum of one week interval within six weeks of study registration, or
   * Radiographic progression in soft tissue and/or bone within six weeks of study registration
2. Ongoing androgen deprivation therapy with serum testosterone \<50 ng/dL (\<1.7 nmol/L).
3. Planned to start abiraterone acetate or enzalutamide.

Exclusion Criteria:

1. Age \< 18 years.
2. Eastern Cooperative Oncology Group (ECOG) performance status \>2.
3. Planned to receive palliative radiotherapy within the next 12 weeks.
4. Hemoglobin \< 90 g/L independent of transfusion.
5. Platelet count \< 50 x 10\^9 / L.
6. Serum albumin \< 30 g/L.
7. Serum creatinine \> 1.5 x Upper Limit of Normal (ULN) or a calculated creatinine clearance \<30 L/min.
8. Contraindications to FDG.
9. Inability to lie supine for imaging with PET-CT.
10. Inability to undergo CT due to known allergy to contrast.
11. Inadequate hepatic function: (i) Bilirubin \>1.5 x ULN, and (ii) Serum glutamic oxaloacetic transaminase (SGOT) \>3 x ULN
12. Inability to complete the study or required follow-up
Normalization of dyrk1A and APP Function as an Approach to Improve Cognitive Performance and Decelerate AD Progression in DS Subjects: Epigallocatechin Gallate as Therapeutic Tool

Epigallocatechin-3-gallate (EGCG), the major catechin in green tea, is postulated to modulate dual specificity tyrosine-phosphorylation-regulated kinase 1A (DYRK1A) and amyloid beta precursor protein (APP) gene overexpression in the brains of Down syndrome mouse models. The clinical study is aimed at demonstrating that normalization of Dyrk1A and APP functions is a therapeutic approach to improve cognitive performance and decelerate AD (Alzheimer's disease) like progression.


Eligibility Criteria:
Inclusion Criteria:

* Have been diagnosed of DS neurological disease, aged between 14-29 years.
* Have given the consent to participate (official custody).

Exclusion Criteria:

* Subjects with neurological disease other than DS, relevant medical disease, co-morbid mental disorder or currently taking any treatment that could interfere with cognitive function or alter any key biomarkers and biochemical parameters analyzed.
* Having suffered from any major illness or undergoing major surgery in the last three months before the study.
* Regular ingestion of medication in the month preceding the study (exceptions for single doses of symptomatic medication administered up to the week preceding the trial).
* Current ingestion of vitamin supplements or catechins or AINE in the two weeks preceding the study.
* History of gastrointestinal, hepatic or renal problems or any other cause that may alter processes of absorption, distribution, metabolism, or excretion of the drug, or that might suggest gastrointestinal irritation to drug.
* Subjects following a vegetarian diet.
* Practice of physical exercise for more than 2 hours per day or energy consume/consumption of more than 3000 kcal per week.
Contingency Outcomes in Prolonged Exposure

The aim of this research is to assess whether Contingency Management is effective in improving treatment adherence in substance use disordered (SUD) patients with comorbid PTSD. Although Prolonged Exposure therapy (PE) is the gold standard treatment for PTSD, the few studies of this treatment in substance users have shown poor adherence. Contingency Management is a well-established approach that could be used to enhance adherence to PE. From a consented sample of 125 opioid-dependent and methadone-treated patients at Addiction Treatment Services, an intent-to-treat sample of 62 patients with co-occurring current PTSD will be offered PE. Half of the 62 participants will be randomly assigned to a Prolonged Exposure with Contingency Management (PE+CM) condition that provides monetary-based incentives for attending the PE therapy sessions. The comparison condition will be assigned to a Prolonged Exposure (PE) condition without the attendance incentives intervention. The PE sessions will be scheduled once per week for 12 weeks, with a 12-week follow-up. Groups will be compared primarily on adherence to the PE schedule, improvement in PTSD symptoms, and rates of drug use (urine specimens, self-reported use). The study's three primary aims are to 1) Evaluate the efficacy of adding voucher-based attendance incentives to PE for PTSD to increase adherence in SUD patients in a methadone treatment program; 2) Evaluate the efficacy of adding voucher-based attendance incentives to PE for PTSD to reduce PTSD symptoms in SUD patients; and 3) Evaluate the effect of PE for PTSD on rates of drug use in SUD patients.


Eligibility Criteria:
Inclusion Criteria for Phase I (evaluation):

* positive screen for PTSD, as determined by score on the MPSS-R
* methadone maintenance for at least 4 weeks (to help ensure initial stabilization on methadone)
* at least 18 years of age

Inclusion criteria for Phase 2 (treatment):

* confirmation of current PTSD based on the Clinician-Administered PTSD Scale
* no psychiatric contraindications to PE (e.g., current suicidal/homicidal intent)
* clear memory for the traumatic event (e.g., flashbacks or re-experiencing the event)
* interest in receiving PE
* agree to sign release of information for any current psychiatric treatment providers outside of ATS
* agree to delay taking daily methadone dose on exposure therapy days until after session
* no history of prior exposure-based therapy for PTSD
* agree to audiotaping of therapy sessions

Exclusion Criteria:

* pregnancy
* acute medical problem that requires immediate and intense medical management (e.g., AIDS defining illness; active tuberculosis)
* presence of a formal thought disorder, delusions, hallucinations, or imminent risk of harm to self or others
Task-dependent Operation of a Mechanism Intracortical Inhibition in Dystonia

Cortical excitability depends on inhibitory mechanisms efficiency among which long latency intracortical inhibition (LICI) can be studied by paired pulses transcranial magnetic stimulation (TMS). Some recent evidences suggest that LICI may be one of the mechanisms by which the motor comment is adapted to the ongoing motor task with LICI strength being dependent on task complexity. In writer cramp and musician cramp, two forms of dystonia, the cortical excitability is not correctly modulated in some complex gestures. the hypothesis is that this task dependent perturbation of excitability in writer cramp could be due to a lack of LICI efficiency.


Eligibility Criteria:
Inclusion Criteria:

* Patient with hand dystonia : writers cramp
* Subject affiliated to social security regimen.

For healthy volunteers :

* Healthy volunteer without neurological disorders based on sensorimotor examination.
* Subject affiliated to social security regimen.

Exclusion Criteria :

* Subject unable to receive informed consent (dementia).
* Contraindication to Transcranial Magnetic Stimulation(TMS) (epilepsia, intracranial metalic foreign object, hearing device, cochlear implant).
* Patient using a psychotrope treatment.
* Patient under guardianship or curatorship.
* Pregnant or nursing women.
* Patient with a cardiac stimulator.

For healthy volunteers only :

• Abnormal neurological evaluation based on sensorimotor examination or neurological history ( epilepsy, stroke ; brain or spinal cord surgery ; history of neurological disease affective sensitive and motor control)
Osseodensification Versus Motor-Driven Expanders' Techniques for Increasing Bone Density With Simultaneous Implant Placement

The aim of this study was to compare and measure the amount of bone density and ridge width gained with motor driven expanders and densifying burs with simultaneous dental implant placement.

Seven patients were treated by the osseodensification technique and another seven were treated by the motor-driven expanders' technique with simultaneous implant placement.

Eligibility Criteria:
Inclusion Criteria:

* Patients requiring implant placement in the anterior maxilla until the premolar region.
* Patients are medically fit.
* The width of the deficient maxillary alveolar ridge not less than 3mm.
* Patients willing and fully capable to comply with the study protocol.

Exclusion Criteria:

* Atrophic ridge (2 mm or less) with no interposition of cancellous bone between the buccal and palatal plates.
* Uncontrolled metabolic disease (e.g. uncontrolled diabetes).
* Heavy smokers (\>15 cigarettes/day).
* Acute oral infections.
* Untreated periodontal disease.
* Poor oral hygiene.
* Pregnant or breastfeeding patient.
* A history of radiotherapy to the head and neck region or treatment with bisphosphonates.
* Female patients using oral contraceptive pills.
* Presence of oral parafunctional habits.
* Surgical site needs to be grafted.