cyrilzakka/clinical-trials huggingface dataset:
Lung Ultrasound Score (LUS) Change in Robotic and Laparoscopic Urologic Surgeries

Robotic and laparoscopic surgeries are tend to cause lung atelectasis due to the insufflation of CO2 into abdomen. However, ultrasonographic measurement for this phenomenon and its clinical use is not well investigated. In this particular study, It is aimed to observe lung ultrasound score (LUS) changes in robotic and laparoscopic supine position surgeries such as prostatectomies and cystectomies. LUS is a pragmatic measurement method that calculates the degree of atelectasis and consolidation in the lungs. Both hemithoraxes are separated into 3 different segments with vertical lines (one between the parasternal line and anterior axillary line, one between the anterior and posterior axillary line, and one posterior to the posterior axillary line). These vertical segments are also divided into two with an horizontal line on the nipple. Lung ultrasonography is applied in all 12 zones for both lungs in the intercostal regions and a scoring system is used. Accordingly, pure A lines (transverse frequent lines) reflects normal lung tissue with no consolidation and scored as zero points (Also named "A"). If less than 4 B lines (vertical lines reflecting some degree of consolidation) is observed, it refers to 1 point (named "B1"). 4 or more B lines refers to 2 points (B2), and if wide and coalesced B lines or patchy pleural line is observed that refers to 3 points (C). All evaluations will be made in supine position.

In this trial, LUS will be applied in three different time points:

T1: 5 minutes after orotracheal intubation T2: At the end of surgery, before extubation (under deep anesthetic state) T3: 30 minutes after extubation, in postanesthesia care unit During the surgery and the postoperative care period standart monitorization and mechanical ventilation data will be gathered. Also intraoperative and postoperative blood gas analysis will be obtained to observe oxygenation changes.

This study is planned as a prospective observational study and our hypothesis is that LUS scores would be lower in acute postoperative period with robotic and laparoscopic surgeries. Therefore primary outcome is the numeric change in T3 and T1. Secondarily, LUS scores will be evaluated between robotic group and laparoscopic group patients for all time points.


Eligibility Criteria:
Inclusion Criteria:

* \>18 years
* Laparoscopic urologic surgeries
* Robotic urologic surgeries
* Surgeries under supine and trendelenburg position

Exclusion Criteria:

* Known lung disease
* Emergency surgeries
* Known cardiac failure
* Known pulmonary hypertension
* Patients receiving inhaled agents
* Patients requiring lateral position surgeries
Deep Brain Stimulation of the Nucleus Accumbens and the Ventral Anterior Internal Capsule for Severe Alcohol Addiction

The main objective of this study is to assess the efficacy of bilateral deep brain stimulation (DBS) of the nucleus accumbens (NAc) and the ventral anterior internal capsule (VC) as a novel treatment in severe alcohol addiction. The included patients have been treated so far with drugs that inhibits alcohol, or psychological behavior training.

Our hypothesis is that bilateral NAc-VC DBS will significantly reduce the craving for alcohol and thus enable the patients to decrease their alcohol intake substantially.

The nucleus accumbens (NAc) is considered associating with addiction. The ventral anterior internal capsule(VC) is proved a effective target to obsessive compulsive disorder(OCD). Like other addiction behaviors most alcohol addicts contain obsessive compulsive symptom. We explored an operation method, that is, in the Leksell stereotactic positioning system take VC as the point of entry, take NAc as the point of target, then make sure that the distance between entry and target points are included in the four contacts of electrode of DBS. When stimulator is ON the investigators can adjust parameters so that the coverage of electrode contains both Vc and NAc. The investigators suppose that bilateral NAc-VC DBS will significantly reduce the craving for alcohol and thus enable the patients to decrease their alcohol intake substantially.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Long lasting alcohol addiction (fulfilled diagnostic-criteria according to DSM-IV,ICD-10)
* At least one detoxication-treatment without a long-term period of abstinence has already taken place
* Long-term inpatient treatment to support abstinence have occurred
* Free patient's decision / Informed Consent (existing comprehensive ability in meaning, methodology and execution of the study and ability of acceptance)
* If prior medication, stable dosage of psychopharmacological drugs over the last three months, which shall, after checking be retained during the study

Exclusion Criteria:

* Hospitalization for psychotic symptoms
* Clinical relevant psychiatric comorbidity (such as schizophrenic psychoses, bipolar affective diseases, severe personality disorder, and so on. And diagnosed by criteria according to DSM-IV,ICD-10)
* Contraindications of a MRI-examination, e.g. implanted cardiac pacemaker/ heart defibrillator
* Current and in the last six months existent paranoid-hallucinated symptomatology
* Foreign aggressiveness in the last six months
* Verbal IQ \< 85 (evaluated with the Wechsler Adult Intelligence Scale- Chinese Revised (WAIS-CR)
* Stereotactic respectively neurosurgical intervention in the past
* Other neurological diseases
* Contraindications of a stereotactic operation, e.g. increased bleeding-disposition, cerebrovascular diseases (e.g. arteriovenous malfunction, aneurysms, systemic vascular diseases)
* Serious and instable organic diseases (e.g. instable coronal heart disease)
* tested positively for HIV
* pregnancy and/or lactation
Behavior Enhances Drug Reduction of Incontinence (BE-DRI)

The primary aim of this study is to test if the addition of behavioral treatment to drug therapy for the treatment of urge incontinence will increase the number of patients who can discontinue drug therapy and sustain a significant reduction of incontinence.


Eligibility Criteria:
Inclusion:

* Female
* Urge predominant incontinence
* Incontinent \> 3 mos
* Available for 8 mos of followup

Exclusion:

* Pregnancy or \< 6 mos post-partum
* Hypersensitivity to drug (tolterodine)
* Systemic disease that affects bladder function (e.g., Parkinson's disease, Multiple Sclerosis, spinal cord injury)
* History of extensive behavior treatment
The Effect of Myofascial Release Exercises on Viscoelastic Changes of the Pectoralis Major Muscle, Pain, Range of Motion and Shoulder Functionality in Individuals Receiving Adjuvant Radiotherapy After Breast Cancer Surgery

Chemotherapy, hormone therapy and radiotherapy used in the treatment of breast cancer try to prevent the recurrence of cancer. In addition to the benefits of radiotherapy, such as a decrease in recurrence and an increase in long-term survival, it may have side effects that may affect the well-being and daily life activities of patients. One of the treatment modalities used to cope with treatment-related side effects is myofascial release exercises. Myofascial release exercises can help reduce adhesions caused by scar tissue and fibrosis caused by radiation. In the literature, there is no study investigating the effect of myofascial release exercises on pectoralis major muscle viscoelastic structure. For this purpose, our study aims to investigate the effect of myofascial release exercises performed in addition to home exercise programme on pectoralis major muscle viscoelastic structure, pain, range of motion and shoulder functionality.


Eligibility Criteria:
Inclusion Criteria:

* -Stage I-II-III defined by radiation oncologists after breast cancer surgery and who will start radiotherapy
* Breast conserving surgery or total mastectomy with axillary lymph node dissection during surgery
* No neurological or orthopaedic problems that may limit the range of motion of the shoulder joint in the preoperative evaluations,
* Individuals who volunteer to participate in the study will be included.

Exclusion Criteria:

* Previous breast clamp surgery on the same side or contralateral side,
* With a metastatic cancer focus,
* Post-surgical resistance, infection and open wound, pacemaker,
* Patients with a Mini Mental State Examination test score of less than 21 will be excluded from the study.
Study of the SilverHawk™ /TurboHawk™ Plaque Excision Systems Used With SpiderFX to Treat Calcified Peripheral Arterial Disease (DEFINITIVE Ca++)

This is a multi-center, non-randomized, single arm study of the SilverHawk™ /TurboHawk™ plaque excision systems when used in conjunction with SpiderFX™ embolic protection device in treatment of moderate to severely calcified peripheral arterial disease in the superficial femoral and/or popliteal arteries.


Eligibility Criteria:
Inclusion Criteria:

* Provides written informed consent
* Willing to comply with follow-up evaluations at specified times
* Has leg pain due to peripheral arterial disease
* Disease located within the femoropopliteal artery
* Moderate to severe calcification

Exclusion Criteria:

* Previously implanted stent(s) or stent graft(s) in target leg
* Life expectancy less than 12 months
* Has any planned surgical or endovascular intervention of target vessel 30 days before or after index procedure
Coaching for Advanced Practice Providers

This study aims to determine if online coaching is feasible in advanced practice providers (APP) and can impact burnout.

The study will recruit APPs from Children's Healthcare of Atlanta (CHOA), Emory, Colorado University (CU), and their affiliate hospitals through online consent sent via email. Interventions will include online video coaching, written coaching, and self-coaching through self-study material.

The purpose of this study is to determine the feasibility of establishing a coaching program directed toward Advanced Practice Providers (APPs), to determine the generalizability of tools shown to relieve physician burnout in the population of APPs, and to advance research in the field of healthcare wellness.

The coaching group will have a curriculum of self-study modules, pre-recorded webinars, and worksheets. The coaching group will also have access to two live group calls per week as well as an online forum to receive anonymously written coaching. After four months, participants will be switched to the other group, so that each participant is exposed to treatment but at separate times. At the completion of each intervention time point, participants will fill out a post-study survey.

Eligibility Criteria:
Inclusion Criteria:

* Advanced Practice Providers (nurse practitioners, physician assistants, certified midwife nurses, certified registered nurse anesthetists, anesthesiology assistants, and clinical nurse specialists) at Children's Healthcare of Atlanta, Emory University, and CU and its affiliate hospitals.
* Pregnant women will be included in this population, though this inclusion is incidental.

Exclusion Criteria:

* adults unable to consent,
* individuals who are not adults,
* prisoners,
* cognitively impaired or individuals with impaired decision-making capacity and
* individuals who do not clearly understand English.
A Study to Evaluate Sapablursen (Formerly ISIS 702843, IONIS-TMPRSS6-LRx) in Patients With Polycythemia Vera

The main purpose of this study is to evaluate the efficacy of sapablursen in reducing the frequency of phlebotomy and in improving quality of life assessments in participants with polycythemia vera.

This is a Phase 2a, multi-center, randomized, open-label study of sapablursen in up to 40 participants with PD-PV. The study consists of 4 periods: 1) Screening Period: up to 7 weeks; 2) Treatment Period: 37 weeks 3) Treatment Extension Period: 36 weeks; 4) Post-treatment Period: 13 weeks.

In the Treatment Period, study drug is given by subcutaneous (under the skin) injection(s). There will be a total of 9 doses given over about 8 months.

In the Treatment Extension Period, there will be a total of 9 doses given over about 8 months.

Participants will be assigned to receive one of 2 Dosing Levels - a higher or a lower level, with an equal chance of being assigned to either Dosing Level. All participants will receive study drug; there is no placebo.

This study was extended to allow participants to receive sapablursen for an additional 36 weeks following the initial 37-week treatment period.

Eligibility Criteria:
Inclusion Criteria

1. Meet modified World Health Organization (WHO) 2016 diagnostic criteria for polycythemia vera (PV) at the time of clinical diagnosis
2. Participant must be phlebotomy dependent.
3. Participants do not need to be on cytoreductive therapy and do not need to have been previously treated with cytoreductive therapy. If the patient was previously on cytoreductive therapy it must have been discontinued at least 3 months prior to Screening, with all associated AEs resolved. If the patient is currently on cytoreductive therapy they must be on a stable dose of hydroxyurea, recombinant or PEGylated interferon, or ruxolitinib for at least 3 months prior to Screening.

Exclusion Criteria

1. Meets criteria for post-polycythemia vera myelofibrosis (PPV-MF) as defined by the International Working Group- Myeloproliferative Neoplasms Research and Treatment (IWG-MRT)
2. Moderate to severe splenic pain or spleen-related organ obstruction
3. Active or chronic bleeding within 1 month of Screening, significant concurrent/recent coagulopathy, history of immune thrombocytopenic purpura (ITP)
4. Known primary or secondary immunodeficiency
5. Active infection with human immunodeficiency virus (HIV), hepatitis C, or hepatitis B.
6. Active infection requiring systemic antiviral or antimicrobial therapy or active novel coronavirus disease (Covid-19) infection
7. Malignancy within 5 years, except for basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or non-metastatic prostate cancer that has been successfully treated
8. Surgery requiring general anesthesia within 1 month prior to Screening
Airway Vascular Lesions

Controversy exists in the treatment of airway hemangiomas ranging from tracheotomy, various lasers, to open removal, none of which have proven to be a gold standard. Venous malformations of the airway are difficult to treat and also require laser therapy or open removal and often repeated treatments are required. Similarly airway lymphatic malformations can require multiple treatment modalities as well as multiple procedures and are infrequently eradicated when extensive. New uses for various lasers and differing treatment protocols are frequently developed. Review of the treatment modalities and efficacy of these methods is required. The goal of this research is to determine protocols for treatment of airway vascular malformation and to evaluate our results from treatment of these lesions.


Eligibility Criteria:
Inclusion Criteria:

* Airway Vascular Lesion

Exclusion Criteria:

* None at this time
Sexual Hepatitis C in HIV Positive Men Who Have Sex With Men (MSM) in Bordeaux

The main objective of this study is to analyse sexual behavior of HIV + MSM in Bordeaux, who have sexually contracted hepatitis C between January 1st 2013, to January 31, 2017. These data will bring some improvement about prevention and maybe reduced the hepatitis C incidence.

Hepatitis C (HCV) is considered in part as a sexually transmitted infection (STI). A marked decrease in its incidence has been observed for several years, coinciding with the availability of new direct acting antiviral treatments (DAA). However, people are increasingly infected with the hepatitis C virus, especially HIV-positive MSM. This increase is explained by new sexual practices that are particularly at high level of risk, despite the widening accessibility of new DAA. Prevention also plays an important role in implementing an effective risk reduction policy. New methods of prevention must therefore be developed. For this purpose, it is imperative to know the natural history of acute hepatitis C, the different behaviours at risk of HCV transmission, and the demonstration of socio-sexual networks (clusters) thanks to virological phylogenetic studies. In order to improve hepatitis C prevention, we wish to establish a descriptive study focusing on :

* Descriptive analysis of the natural history of hepatitis C,
* Identification of patient clusters (phylogenetic analysis)
* Description of the sexual behaviors of infected patients, through a semi-directed interview.

Eligibility Criteria:
Inclusion Criteria:

* Patient older than 18 years
* HIV-1 and/or HIV-2 confirmed Infection
* Men who have sex with Men
* Patients included in the "ANRS CO3Aquitaine cohort".
* HCV contamination documented over the period 01/01/2013 to 01/31/2017 (A positive HCV serology and a HCV plasma RNA positive) AND a negative HCV serology OR a positive HCV serology and a negative plasma RNA before inclusion period
* A person who has received information about the protocol and has given oral consent and that his / her non-opposition is documented in his / her medical file.

Exclusion Criteria:

* Transfusion contamination
* Substance abuse IV out of SLAM context
* Refusal to consent to research.
Paracetamol for Intrapartum Analgesia

The aim of this study is to assess whether paracetamol is as effective as pethidine for analgesia during the first stage of labor.


Eligibility Criteria:
Inclusion Criteria:

* Primiparity
* Active phase of labor (cervical dilatation of 3-5 cm, in the presence of adequate uterine contractions; lasting at least 40 seconds at intervals of 3-4 minutes)
* Maternal age between 20-30 years
* Singleton term pregnancy (37-42 weeks of gestation)
* Vertex-presenting fetus

Exclusion Criteria:

* Clinical evidence of cephalopelvic disproportion
* Scarred uterus; previous cesarean section, hysterotomy or myomectomy
* Medical disorders associated with pregnancy, especially gastritis, peptic ulcer, bronchial asthma or renal impairment
* Fetal distress
* Receiving any regional or parenteral analgesia before recruitment in the study
* Known hypersensitivity to the drug family
Bariatric Surgery and the Kidney

The purpose of the project is to study the relationship between post-bariatric surgery changes in weight and renal parameters.


Eligibility Criteria:
Inclusion Criteria:

* bariatric patients

Exclusion Criteria:

* age \<18
* dialysis dependency
Non-Invasive ctDNA Methylation Detection for Lung Nodule Patients

Low-dose computed tomography (LDCT) is recommended for early-stage lung cancer screening. However, it is often difficult to determine indolent lesions from more aggressive tumors without an invasive intervention or prolonged follow-up period. Thus, the main purpose of this study is to develop a non-invasive method to detect lung-cancer specific circulating tumor DNA (ctDNA) in blood, which can greatly improve the specificity of lung cancer early screening.

In this study, the investigators sought to explore sensitive and specific methylation biomarkers that are highly prevalent in lung cancer. It is the first time to perform screening assay on healthy, lung nodule, and lung cancer tissues to identify preliminary set of highly prevalent methylation markers, and then refined these markers by removing regions were unstable in matched plasma samples. Next, investigators interrogated significant methylation marker regions enriched in lung nodules of training sample set to buildup a non-invasive biomarker classification model to discriminate cancerous nodules from benign lesions. Eventually, the model in patient lung nodule samples were validated.

Eligibility Criteria:
Inclusion Criteria:

1. 18 years old or above with pulmonary nodule(s) found by LDCT, mean diameter below 30mm.
2. The nodule lesion is peripheral, no signs of lymphatic infiltration or distal metastasis.
3. Fit and consent to surgical resection.
4. Agree to participate in this study and sign informed consents.

Exclusion Criteria:

1. Fail to understand or agree to sign informed consent.
2. Patients who did not follow the test plan for timely blood collection or did not cooperate with the study follow-up work.
3. Patients with previous history of cancer and/or cancer treatment such as surgery, radiotherapy, chemotherapy or targeted therapy.
4. Failing to meet the requirements for blood sampling.
An Extension Study to Evaluate the Long-Term Safety and Efficacy of PTC518 in Participants With Huntington's Disease (HD)

The primary goal of this study is to evaluate the long-term safety and pharmacodynamic effects of PTC518 in participants with HD.

Participants who completed the Treatment Period in the parent Phase 2a Study PTC518-CNS-002-HD (NCT05358717), fulfilled the enrollment criteria, and chose to enroll in this extension study will undergo baseline evaluations and be assessed for 30 additional months.

All participants will receive active PTC518 in this extension study. Participants who received PTC518 in the parent Study PTC518-CNS-002-HD will continue at the same dose level they received in that study in a blinded fashion (5, 10, or 20 milligrams \[mg\]). Participants who received placebo in the parent Study PTC518-CNS-002-HD will be allocated to a PTC518 dose level according to the same dosing group in which they were previously randomized (5, 10, or 20 mg). The 20 mg dosing arm will be open for randomization only if and when the Data Safety and Monitoring Board from the parent Study PTC518-CNS-002-HD recommends initiating this dosing level based on an unblinded review of safety data from that study.

Eligibility Criteria:
Inclusion Criteria:

* Participant who has completed the Treatment Period in Study PTC518-CNS-002-HD.

Exclusion Criteria:

* Participants who have not previously completed the Treatment Period in Study PTC518-CNS-002-HD.

Note: Other inclusion and exclusion criteria may apply.
An Open Label Study of Levetiracetam Monotherapy in Patients With Newly Diagnosed Focal Epilepsy

The purpose of this study is to evaluate the efficacy of Levetiracetam (LEV) used as monotherapy, with efficacy measured as 6-month seizure freedom at the last evaluated dose in the LEV 1000 mg/day to 2000 mg/day group, in newly or recently diagnosed epilepsy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Subject is male or female and aged ≥ 16 years at Visit 1
* Subjects with newly or recently diagnosed Epilepsy having experienced unprovoked Partial Seizures (IA, IB, IC), that are classifiable according to the International League Against Epilepsy (ILAE) classification of Epileptic Seizures
* Subjects with at least 2 unprovoked seizures separated by a minimum of 48 hours in the year prior to Visit 1, of which, at least 1 unprovoked seizure occurred in the 3 months prior to Visit 1
* Minimum body weight of 40 kg at Visit 1

Exclusion Criteria:

* Subject has a history or presence of seizure types other than partial (IA, IB, IC)
* Subject has an experience of any type of brain surgery in the consecutive 2 years prior to Visit 1
* Subject has a history or presence of known Pseudo-Seizures
* Subject has been treated for Epilepsy with any Antiepileptic Drug (AED) within the 6 months prior to Visit 1. However, acute and sub-acute seizure treatments are accepted for a maximum use of 2 weeks, if the treatments are stopped for the week prior to Visit 1
* Subject has a known clinically significant acute or chronic illness, such as but not restricted to: cardiac, renal, hepatic dysfunction, endocrinological, or psychiatric illness, and that may impair reliable participation in the study or necessitate the use of medication not allowed by the protocol