cyrilzakka/clinical-trials huggingface dataset:
MUltimodal Targeted Axillary Surgery

The present trial will prospectively evaluate the accuracy of both a systematic predefined axillary ultrasound imaging together with tumor load quantification of suspicious and sentinel axillary lymph nodes to predict overall tumor load in the axilla.

Axillary node clearance (ANC) is a controversial intervention in the surgical treatment of breast cancer. Different studies have shown that in some patients with infiltrated axillary lymph nodes but low tumor burden, ANC can be safely omitted. However, indications for ANC persist in nowadays for patients with positive axillary lymph nodes and upfront surgery and patients with positive lymph nodes after neoadjuvant treatment. The present prospective study will evaluate the ability to establish an axillary tumor load with two steps. The first step will be a preoperative predefined systematic axillary ultrasound imaging workflow. The second step will be the tumor load evaluation of suspicious and sentinel axillary lymph nodes. We will also evaluate which patients have infiltrated nodes only beneath the second intercostobrachial nerve. The trial intends to identify patients for who a complete axillary node clearance could be spared.

Eligibility Criteria:
Inclusion Criteria:

* Node-positive breast cancer patients confirmed by biopsy or cytology
* Positivity confirmed before the surgical treatment

Exclusion Criteria:

* Inability to confirm positive lymph nodes by biopsy or cytology
* Inability to understand the protocol design
* Poor understanding of the Spanish language
RemI for Post-Bariatric Surgery Weight Regain

The goal of this clinical trial is to test the effectiveness of remotely-delivered interventions (utilizing acceptance-based behavioral treatment skills (ABTi)) amongst bariatric surgery populations who are experiencing weight regain postoperatively (\> 5% from their lowest postoperative weight and after postoperative Month 6). Investigators aim to evaluate ABTi's efficacy for reversing weight regain and its effect on targeted weight control behaviors and weight-related comorbidities by comparing participants randomly assigned ABTi (n = 100) to those assigned to a Control group that also receives brief phone calls but that focus on reiterating instruction on the dietary and behavioral changes required of surgery and initially taught preoperatively (C, n = 100).

The main research aims are:

1. To compare changes in body weight over 12 months in 200 bariatric patients who have regained \> 5% of their weight and are randomly assigned to ABTi or Control.
2. To compare changes in eating behaviors (i.e., caloric intake, frequency of maladaptive eating behaviors), physical activity, and weight-related comorbidities (i.e., biomarkers of diabetes, hypertension) over 12 months in the two groups.
3. Exploratory - To test ABTi's theoretical mechanisms of action, including a) effects of theory-based active ingredients (i.e., acceptance, defusion, values clarity, mindfulness) on weight outcomes and b) changes in impact of internal states (i.e., hunger, cravings) on eating behavior.


Eligibility Criteria:
Inclusion Criteria:

* Men and women
* Ages 18-70 years old
* Weight regain of at least 5% from lowest postoperative weight
* Underwent gastric bypass or sleeve gastrectomy within 6 to 48 months prior to enrollment
* Ability to give consent
* Ability to speak, write, and understand English

Exclusion Criteria:

* Long-term treatment with oral steroids
* Current use of weight loss medication (OTC or prescription)
* Current pregnancy or plan to become pregnant within 12 months
* Psychiatric hospitalization in the past 6 months
* Documented or self-reported psychiatric diagnosis that would interfere with adherence to the study protocol or acute suicidality
* Self-report of alcohol or substance abuse within the past 12 months
* Current, self-reported use of tobacco products
* Weight loss \> 10 lbs in the past 3 month
* History of more than one bariatric procedure
* Inability to walk at least one city block without assistance
Respiration Rate Monitoring During Transitions

The purpose of this study is to evaluate the performance of the software that calculates respiration rate for the study pulse oximetry monitoring system during transitions of ventilation type from spontaneous breathing to controlled ventilation.


Eligibility Criteria:
Inclusion Criteria:

* Be undergoing a procedure with planned general anesthesia involving placement of an endotracheal tube or laryngeal mask airway following induction of anesthesia.
* American Society of Anesthesiologists physical status classification (ASA) Status 1, 2 or 3.
* Body mass index (BMI) ≤30 kg/m2.
* Subject is willing and able to provide written consent.

Exclusion Criteria:

* Female subjects of child-bearing potential with a positive pregnancy test or an absence of documented non-childbearing status in the medical history records.
* Female subjects who are currently lactating and breastfeeding.
* Subjects with any evidence of potential difficulty in mask ventilation and/or tracheal intubation.
* Subject has an abnormality that may prevent proper application of the device/sensors.
* Subject is in atrial fibrillation.
* Subject has a documented history of frequent premature ventricular contractions (PVCs), defined as greater than 3 in 30 seconds or greater than 6 in 60 seconds.
* Subject has an implanted pacemaker.
* Subjects with non-sinus rhythm, frequent premature ventricular complexes (\> 5 min), or abnormal PR, QRS, or QT intervals on screening ECG.
* Subjects with artificial finger nails.
Effects on Shoulder Pain of Simulated Hyper-gravity During Rehabilitation Exercises

Determine if adding "extra-gravity" (sustained increase in vertical loading) during standard rehabilitation exercises has a beneficial effect on pain reduction in subjects suffering from shoulder pain of different origin.

Standard rehabilitation protocols will be used with every subject, depending on the cause of their shoulder pain. The treating clinician will determine the appropriate therapy protocol for each subject.

During the treatment sessions, subjects will wear a very comfortable waist belt attached with rubber band to anchor points on the ground (the rubber bands will be tighten to simulate the extra-gravity).

Upon enrollment, the treating clinician will randomly assign the subject to one of four groups depending on the type of loading and exercise typology.

The hyper-gravity will be simulated as an additional 50% of subject's body weight.

The frequency and duration of each therapy session will be determined by the treating clinician (usually 45 minutes of therapy twice a week for 4 weeks).

Before, after and 24h post therapy session, the subject will grade the pain level using a numeric pain scale (0 no pain; 10 unbearable pain requiring pain medication).

As part of the rehabilitation therapy procedure, subjects will undergo shoulder range of motion evaluations (done by a trained clinician in approximately 3 minutes) and Computer Dynamic Posturography (CDP) testing on a 4" tall foam cushion with eyes closed (PSEC test - less than 1 minute of testing) before and after each therapy session.

Subjects will complete the DASH and TOSSA questionnaires (the total amount of time required to complete these assessment is \~20 minutes), and will be tested using the modified Clinical Testing of Sensory Integration in Balance (mCTSIB) protocol (the subjects will be required to stand on a hard or compliant surface (a 4" tall foam cushion of known mechanical properties) in a comfortable posture, feet shoulder width, with eyes open or closed, head straight and arms to the side and free to move, gazing forward, and breathing normally, less than 2 minutes testing time) at the time of enrollment and at the end of the 4 week therapy program.

Subjects will be asked to come back for two more evaluations (questionnaires, range of motion assessment, and CDP testing) one month and three months after the end of the 4 week therapy program to identify possible long term effects of the "hyper-gravity/accentuated vertical loading" therapy.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of shoulder pain (potentially including rotator cuff pathology, impingement, bursitis, SLAP tear)

Exclusion Criteria:

* adhesive capsulitis, fracture, dislocation, inflammatory arthritis, cancer, ligament disruption
Phase 2 Study for the Treatment of Superficial Lipomas

The purpose of this research is to compare the safety and effectiveness of 3 different concentrations of deoxycholic acid for injection against a placebo in the treatment of superficial lipomas.

A lipoma is a fatty lump typically located on the trunk, shoulder, arms, or legs. For the purposes of this study, only lipomas on the trunk, arms, legs, or neck were treated. (Lipomas on the face, wrists, hands, lower portion of the spine, genitals, ankles, or feet were not treated.)

Eligibility Criteria:
Inclusion Criteria:

* One or more lipomas, based on clinical and histological diagnosis, which are accessible for treatment and assessment, are quantifiable along at least 2 perpendicular diameters, and have the following characteristics:

  * History of slow growth followed by dormancy, and stable for at least 6 months
  * Greatest length multiplied by greatest perpendicular width between 1 and 16 cm², inclusive
  * Discrete, oval to rounded in shape, not hard or attached to underlying tissue
  * Without changes in overlying skin (ie, inflammation, pain or tenderness, hyperpigmentation)
  * Located on the trunk, arms, legs, or neck
* Signed informed consent.

Exclusion Criteria:

* Absence of significant medical conditions that could affect safety
* History of surgical or deoxycholate treatment for lipomas
* Treatment with an investigational agent within 30 days before ATX-101 treatment
The Relationship of Neuropathic Pain With Incontinence, Disability and Life Quality in Multiple Sclerosis Patients

The aim of this study to evaluate the relationship of neuropathic pain with urinary and bowel incontinence, functional disability and quality of life in patients with multiple sclerosis.

The patient's date of birth, gender, education level, body mass index, occupation, marital status, socioeconomic status, who they live with, the onset of their complaints about the disease, the time of diagnosis of multiple sclerosis (MS), the type of MS, the presence of any pain and the type of pain will be recorded.

Then, while the patients will be evaluated by researcher Dr Alper Mengi in terms of neuropathic pain, incotinance, disability and independence in activities of daily living. The forms to be used in terms of health perceptions and quality of life, anxiety and depression, and sleep quality will be filled by the patients.

Eligibility Criteria:
Inclusion Criteria:

* Being diagnosed with MS according to the 2017 Revised McDonald criteria
* Being between the ages of 18-65
* Being in remission (no progression in attacks or disability in the last 3 months).

Exclusion Criteria:

* Having another known neurological disease
* Having been diagnosed with a psychiatric disease such as depression, anxiety, bipolar disorder
* Having a history of infectious, chronic inflammatory disease, malignancy
* Having cardiac pathology such as heart failure, coronary artery disease
* Diabetes, chronic kidney failure, chronic liver failure
* Being addicted to alcohol and substance
* Using permanent urinary catheter
Effect of Indacaterol on Inspiratory Capacity (IC)

This study is being conducted to assess the effect of indacaterol (150 μg o.d.) on inspiratory capacity (IC), using placebo and open label tiotropium (18 μg o.d.) as comparators in patients with moderate chronic obstructive pulmonary disease (COPD). In particular, spirometric timepoints are included to elucidate the peak-IC in a period of approximately 4 hour post inhalation


Eligibility Criteria:
Inclusion Criteria:

* Co-operative outpatients with a diagnosis of COPD (moderate as classified by the GOLD Guidelines, 2008) and including:

  * Smoking history of at least 10 pack years
  * Post-bronchodilator FEV1 \<80% and ≥50% of the predicted normal value (Visit 2).
  * Post-bronchodilator FEV1/forced vital capacity (FVC) \<70% (Visit 2).

Exclusion Criteria:

* Patients who received any corticosteroid (including inhaled) for 3 months prior to screening

Other protocol-defined inclusion/exclusion criteria may apply
Tolvaptan Open-label Pilot Efficacy, Tolerability, and Safety Study in Autosomal Dominant Polycystic Kidney Disease (ADPKD)

This study's purpose is to evaluate the long-term safety of open-label tolvaptan regimens to determine the maximally-tolerated dose and acquire pilot efficacy data in patients with autosomal dominant polycystic kidney disease (ADPKD).

Autosomal Dominant Polycystic Kidney Disease is a genetic disease classified by the formation of fluid-filled cysts in the kidneys. The accumulation of these cysts causes the kidneys to enlarge several times the normal size and leads to the eventual loss of renal function and ultimately results in renal failure in end-stage patients. This is a disease with life-threatening implications to those who have it, and their family members who may also be affected. Aside from early anti-hypertensive control and dietary protein restriction, which are presumed to offer a modest degree of protection, most surviving patients require renal replacement therapy (dialysis and transplant) and suffer from high morbidity and mortality.

A rationale for use of tolvaptan in these genetic disorders has been proven, in principle, through use of a variety of animal models. In these models, tolvaptan is effective in halting or reversing the progression of this renal disease.

The current study is being undertaken in order to evaluate whether tolvaptan, an oral vasopressin V2 receptor inhibitor, will maintain an adequate safety profile and show a potential clinical benefit by reducing total renal volume in the hopes of making an impact upon disease progression.

Eligibility Criteria:
Inclusion Criteria:

* Prior participation in designated tolvaptan ADPKD studies (156-04-248, 156-04-249).
* Able to give Informed Consent.

Exclusion Criteria:

* Women who are breast feeding and females of childbearing potential who are not using acceptable contraceptive methods.
* In the opinion of the study investigator or sponsor may present a safety risk.
* Patients who are unlikely to adequately comply with study procedures.
* Patients who at Day 1 have an estimated glomerular filtration rate (GFR) below 30 mL/min or who anticipate renal-replacement therapy within one year of study entry.
* Patients having contraindications to magnetic resonance imaging (MRI) or gadolinium contrast will be eligible but will not be able to participate in MRI.
* Patients taking a diuretic within 1 week of enrollment or likely to need diuretic therapy prior to Month 2.
Intraoperative and Postoperative Analgesia for Laparoscopic Surgery.

Main Hypothesis: laparoscopic surgery is very painful to patient during and after surgery. We would like to compare different analgesic methods.


Eligibility Criteria:
Inclusion Criteria:

* Laparoscopic (general) Surgery
* Age\>18
* ASA\<4
* Morning surgery

Exclusion Criteria:

* Patient refusal
* contra-indication for treatment
Evaluation of Asymmetrical Lateral Decubitus for Rotation of Occipitoposterior Fetal Position

Maternal posturing is used during labor to facilitate the rotation of occipitoposterior fetal position in anterior.

Our study aims to evaluate the efficacy of asymmetrical lateral decubitus for rotation of the fetal head.

The prevalence of fetal occipitoposterior position during labor is 20%. Compared to anterior positions, they are known to be at higher risk of complications (cesarean section, instrumental delivery, severe perineal laceration).

Maternal posturing is used during labor to facilitate the rotation of the fetal head in anterior position. Asymmetrical lateral decubitus is used frequently, without having ever been evaluated.

Our study aims to evaluate the efficacy of this maternal posturing, through a randomized open trial.

We hypothesized that posturing women in asymmetrical lateral decubitus allows increasing frequency of anterior fetal position after 1 hour.

Eligibility Criteria:
Inclusion Criteria:

* women older than 18 years
* Gestational age ≥ 37SA,
* Ruptured membranes,
* single living fetus in cephalic presentation with an occipitoposterior position clinically diagnosed between 2 and 9 cm dilated and confirmed by ultrasound.
* Affiliation to a social security scheme (beneficiary or assignee)
* Signing the consent

Exclusion Criteria:

* Fetal presentation other than posterior
* Multiple pregnancy,
* Breech presentation
* History of previous cesarean section
* Fetal death in utero, termination of pregnancy
* Fetal intrauterine fetal growth restriction \<5e percentile,
* Fetal malformation,
* Women younger than 18 years old,
* Women do not understand French,
* Women with psychiatric condition
Comparison of Allows Measurement of Cardiac Output Between Clearsight System and Transpulmonary Thermodilution

Correlation study between the data provided by two measurement systems, trans- pulmonary thermodilution and ClearSight © (non invasive), to determine the interest in routine use (cardiac output, cardiac index, stroke volume and blood pressure).

Since 2014, Edwards society has developed a completely non-invasive monitoring device for measurement of blood pressure and continuous cardiac output without inserting foreign intravascular bodies in the patient. Initially tested on healthy volunteers cardiac disease -free, the correlation with the other devices seems to be good. If this ClearSight © system show a relevant accuracy in measuring blood pressure and cardiac output with a specific ICU hospitalized population, it could justify its place in the therapeutic arsenal of monitoring in intensive care.

This is a common care ,prospective observational single center study , concerning the results of blood pressure , cardiac output values and their variations.

Eligibility Criteria:
Inclusion Criteria:

* age\>18
* hospitalized in surgical ICU, with hemodynamic instability or vaso-active drugs
* No opposition formulated

Exclusion Criteria:

* Impossibility of establishment of one of the cardiac output measurement devices
* Pregnant woman
* Refuse to participate
Castration-resistant Prostate Cancer and Intra-prostatic Hormonal Status

The main objective of the study is to determine the intra-prostatic concentration of sexual steroids when castration resistance appears in castration-resistant prostate cancer patients compared to patients naif of hormonal treatment


Eligibility Criteria:
Inclusion Criteria:

* group 1: patients with a locally advanced prostate cancer naif of any hormonal treatment
* group 2: Patients with a castration-resistant prostate cancer resisting defined by a biological progression
* group 2a: without radiotherapy
* group 2b: with radiotherapy
* Affiliated to a social security scheme
* Having given a written consent.

Exclusion Criteria:

* Patient unable to supply a written consent (patient not understanding French, under guardianship patient).
* neuro-endocrine form or sarcomatoid form prostate cancer
Purrble with LGBTQ+ Youth Who Have Self-harmful Thoughts

The primary aim of the proposed Randomised Control study is to investigate the effects of a socially assisted robot (i.e. Purrble) on emotional regulation difficulties (measured by DERS8) with young LGBTQ+ people who have self-harmful (with or without suicidal intention) (in comparison to a wait-listed control).

Secondary aims include investigating the effects of the Purrble on young people's self-harmful thoughts, symptoms of anxiety and depression, alongside quantitative and qualitative (interviews) measures of engagement with the intervention.

Self-harm is a key concern among young people, this is highlighted by the rising rates self-harm and suicide attempts in recent years. Internationally, young LGBTQ+ people are recognised to report higher prevalence of self-harmful thoughts, behaviours, anxiety and depression than their cisgender, heterosexual peers. Emotion regulation (ER) is known to be a transdiagnostic risk factor, which is widely associated with higher risk of self-harm. Typically, LGBTQ+ populations also report greater difficulties with ER which partially explains association with self-harm.

While LGBTQ+ youth are frequent users of digital technologies and digital interventions are often considered feasible and acceptable, there is limited evidence of the effectiveness of such within these populations. Currently, there is no evidence-based digital interventions targeting LGBTQ+ youth who struggle with self-harm.

To address this gap, the investigators have conducted a small pilot study (n=21) to evaluated one such possible tool - Purrble - as a means to offer in-the-moment emotional support for those with high levels of self-harm risk (high symptoms of anxiety, depression, or self-harmful experiences in the last 6 months). The goals of the study centre around testing the feasibility, acceptability, and usage of Purrble across a 2-week deployment period. These results have been promising, indicating Purrble as a feasible and acceptable intervention, alongside indicators of clinical value during Purrble deployment: i) reduction of anxiety and depression symptoms during deployment and ii) reduced prevalence of self-harm thoughts.

From previous interviews, participants highlighted the positive outcomes which were associated with Purrble use (stopping them reaching the point of thinking about self-harm, being a barrier to self-harm behaviours, and encouraging emotional regulation coping strategies; e.g. grounding, self-soothing). However, these pilot studies did not include a controlled waitlist group, and thus more rigorous investigation of these promising effects is needed - leading to the current study.

Eligibility Criteria:
Inclusion Criteria:

Currently experiencing self-harmful thoughts (within the last month) Identify as sexual orientation or gender identity minority (LGBTQ+) Aged 16-25 years Currently living in the UK at the time of the study Able to read and write in English

Exclusion Criteria:

Young people who live outside the UK, are not within the 16-25 year age bracket, and are not experiencing self-harmful thoughts will not be included in the study.