cyrilzakka/clinical-trials huggingface dataset:
Transcranial Magnetic Stimulation (TMS) in Obesity

Obesity is a metabolic disease that has reached epidemic proportions. Insofar no long-term effective drug treatment was developed for obesity. Lyfe style modulation and bariatric surgery are the only interventions with a limited rate of success. Obesity is due to several factors, mainly linked to a neurophysiological mechanism of "food addiction". The use of repetitive deep Transcranial Magnetic Stimulation (dTMS) was proposed to reduce appetite and food craving in obese subjects, leading eventually to a weight reduction. dTMS was already tested successfully in other forms of addiction (smoking, alcohol, cocaine) and the usefulness of dTMS in the treatment of food addiction, and therefore in obesity, was hypothesized. End-points of this research will be: 1) effect on food craving; 2) acute and chronic effects on blood level of hormones acting on the appetite regulation; 3) chronic effects on body weight. The demonstration that a safe, non-invasive and repeatable methodology can treat obesity reducing food craving and modulating appetite/satiety hormones secretion will constitute a cornerstone in translational medicine of metabolic diseases.


Eligibility Criteria:
Inclusion Criteria:

1. Age: 22-65 years
2. If the patient is taking medications, it must take on a stable dose for at least a month
3. Obesity: ≤ 30 BMI ≤ 45
4. Ability to follow verbal or written instructions.

Exclusion Criteria:

1. Axis-I and II psychiatric disorders according to DSM criteria 5 (such as Major Depression, Bipolar Disorder, or Attention Deficit Disorder)
2. IQ score \< 85
3. Organic brain disorders: history of stroke, brain major surgery or head trauma
4. Pregnancy or lactation, absence of medically approved contraceptive methods in females of childbearing potential
5. Serious or poorly controlled diseases (hepatic, renal or hearth failure, atrial fibrillation or other heart rhythm disorders)
6. H yperglycemia - Fasting glucose level \> 170 mg/dl
7. Urine drug screen positive for amphetamines, barbiturates, cannabinoids, cocaine metabolites, opiates and phencyclidine
8. Positivity to blood alcohol test
9. Metal in any part of the head, except for dental fillings
10. Implanted infusion pumps
11. Intracardiac devices (pacemakers, heart valves ...)
12. History of diseases whose exacerbation could be fatal (e.g. cardiovascular disease, increased intracranial pressure)
13. History of epilepsy or a family history of epilepsy among first-degree relatives
14. Medications associated with lowered seizure threshold (such as antidepressants, anxiolytics...)
15. Treatment with anti-obesity medications or other medications influencing body weight within 3 month prior to Screening Visit
16. Starting a weight loss plan at any time during data collection for the subject
17. Patients affected by galactosemia, priapism and terminal illness
18. Patients on fluid restriction for SIADH or other conditions
19. Contraindications to perform the Magnetic Resonance Imaging (MRI).
Acupuncture Feasibility Trial for Dyspnea in Lung Cancer

This is a single arm clinical trial to establish the feasibility of conducting a clinical trial of acupuncture in reducing dyspnea among lung cancer survivors who have completed chemoradiotherapy. Twelve subjects with dyspnea will be recruited to this clinical trial. Up to 10 sessions of acupuncture will be delivered over the course of 8-10 weeks. The primary outcome will be dyspnea as measured by the English version of the Cancer Dyspnea Scale at the completion of the intervention.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Lung Cancer (Non small cell and small cell both eligible)
* Completion of concurrent CRT at least 6 months prior to randomization.
* Dyspnea which worsened after Chemoradiotherapy, leading to a ATS dyspnea score greater than or equal to 2 (Walks slower than people of the same age on the level because of breathlessness or has to stop for breath when walking at own pace on level)
* Ability to understand written English -Willingness to adhere to all study-related procedures
* Age 18 years old
* ECOG Performance Status 1-3

Exclusion Criteria:

* Current receipt of therapy for treatment related pneumonitis for 3 weeks.
* Surgical resection of this LC (lobectomy or pneumonectomy)
* Another organic cause of dyspnea necessitating treatment (eg pleural effusion appropriate for thoracentesis, rapidly progressive intrathoracic recurrence, symptomatic pulmonary embolus after CRT, untreated anemia with hemoglobin8 g/dL)
* Current bleeding disorder by history
* Life expectancy of 12 weeks, as assessed by primary oncologist
Expanded Access for LOXO-260 in Participants With Cancer Caused by an Abnormal RET Gene That Did Not Respond/is no Longer Responding to Treatment With a Type of Drug Called a RET Inhibitor

Expanded access for participants with cancer caused by an abnormal RET gene that did not respond/is no longer responding to treatment with a type of drug called a RET inhibitor.

The treating physician/investigator contacts Loxo Oncology, Inc. when, based on their medical opinion, a patient meets the criteria for expanded access.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of cancer with RET mutant (medullary thyroid cancer \[MTC\] or multiple endocrine neoplasia type 2 \[MEN2\] tumors) or RET fusion (solid tumors) advanced/metastatic tumors that have become refractory to RET selective tyrosine kinase inhibitor (TKI) treatment, who are not eligible or able to participate in an ongoing LOXO-260 clinical trial and are medically suitable for treatment with LOXO-260.
* Patients tumor must have developed RET solvent front mutations (eg G810X) after RET selective treatment.
* Have progressed or are intolerant to standard therapy, or no standard therapy option exists, or in the opinion of the investigator, are unlikely to derive significant clinical benefit from standard therapy
* Have adequate organ function
* Patients must reside in a country where the LOXO-NGR-21001 study (NCT05241834) is not open or recruiting.

Exclusion Criteria:

* Currently enrolled in an ongoing clinical study of LOXO-260 or another second generation RET inhibitor
* Clinically significant active cardiovascular disease or history of myocardial infarction within 6 months prior to study treatment; ongoing cardiomyopathy; or current prolongation of the QT interval corrected for heart rate using Fridericia's formula (QTcF) interval greater than 470 milliseconds
* Clinically significant malabsorption syndrome
* Pregnant or lactating
* Eastern Cooperative Oncology Group (ECOG) performance status 3 or 4
* Patients harboring known activating bypass alterations outside RET (eg. EGFR, ALK, RAS etc) that may confer resistance to LOXO-260
Bronchial Hyper-responsiveness in Reflux Cough

The study aim is to determine the effect of 8 weeks of anti-reflux treatment (full acid suppression) on bronchial hyper-responsiveness and whether there is a symptomatic improvement.


Eligibility Criteria:
Inclusion Criteria:

* Positive methacholine challenge test PC20 less than 4mg/ml (Can be previously documented in patients notes within last 4weeks)
* Written informed consent
* Patients with a history of chronic cough (at least 3 months duration), and associated symptoms of gastro-oesophageal reflux
* Male and female subjects of at least 18 yrs of age
* Subjects able to perform satisfactory FEV1 manoeuvres
* Subjects able to understand the study and co-operate with the study procedures
* Subjects who consent to their general practitioner (GP) being informed of their study participation

Exclusion Criteria:

* has had a heart attack in the last three months
* suffers from angina, hypertension or ischaemic heart disease
* has epilepsy for which he/she is taking medication
* FEV1\< 60% predicted
* FEV1\<1.6L
* Female subjects who are pregnant, or lactating, or who are of child bearing potential but are not using contraceptive measures
* Suffering from any concomitant disease which may interfere with study procedures or evaluation.
* A lower respiratory tract infection 4 weeks prior to entry on to study
* Participation in another study (use of investigational product) within 30 days preceding entry on to study.
* Alcohol or drug abuse
* Use of opiates to treat cough 1 week prior to enrollment
* Subjects who are taking Angiotensin Converting Enzymes (ACE) inhibitors.
* Subjects who have significant pathology on most recent chest X-Ray.
* Inability to understand the procedures and the implications of a challenge test
* Patients already taking or have taken in last 4 weeks PPI and H2 receptor antagonist (full acid suppression treatment
ENB Robotic ICG Guided Surgery: A Novel Technique for Targeting Small Lung Tumors

Lung cancer is the leading cause of cancer deaths worldwide. However, if diagnosed at an early stage (tumor \<2 cm), lung cancer is highly curable with a 5-year survival rate greater than 80% after surgical resection. Screening tests have made it easier to identify small lung tumors. However, these tumors are often not visible to the naked eye, and surgeons cannot feel them, making them difficult to precisely locate and remove. For this reason, surgeons have become more reliant on image guided surgery for the removal of these tumors.

The standard of care for locating and removing small lung tumors is microcoil-guided video-assisted thoracoscopic surgery (VATS). This is a two-step procedure performed by two separate physicians.

* First, patient is taken to radiology suite and radiologist inserts a microcoil near the lung tumor
* Second (usually occurs a few hours later), patient is taken to operating room; a surgeon uses an x-ray arm to find the microcoil within the lung and remove it surgically.

A pathologist reviews the resected tissue to make sure that the tumor and the microcoil were both removed. Until this evaluation, the surgeon does not know whether the tumor has been removed or not. While this method is safe, it is time consuming, uses staff resources, and requires bulky equipment to complete.

In this study, we plan to develop and test a new method of identifying and removing small lung tumors. This procedure is called Electromagnetic Navigational Bronchoscopy (ENB) Robotic Indocyanine Green Guided Surgery (RIGGS) or ENB-RIGGS for a short name. The purpose of this study is to test the safety and reliability of the ENB-RIGGS surgery in the form of a pilot study.

ENB-RIGGS surgery is done in the operating room by a surgeon under general anesthetic. ENB-RIGGS begins by creating a 3-D GPS map of the lung which guides the surgeon directly to the tumor. A fluorescent green dye called indocyanine green is then injected into the tumor, and when viewed by the special robotic camera the tumour will fluoresce with a green hue allowing the surgeon to easily see the tumour. The surgeon then uses the robot to remove the tumor and surrounding tissue. The lung tissue specimen will be evaluated immediately by a pathologist.


Eligibility Criteria:
Inclusion Criteria:

1. Age \> 18 years
2. Peripheral lung tumour that is \<2 cm in size on a CT scan
3. Fit to undergo thoracic surgery as assessed by the surgeon.

Exclusion Criteria:

1. Hypersensitivity or allergy to ICG, sodium iodide or iodine
2. Women who are currently pregnant or are breast feeding; or women of child bearing potential who are not currently taking adequate birth control.
Cortisone Shots for Neck Pain

The purpose of this study is to determine if cortisone shots in the neck are helpful in patients with certain MRI findings. Additionally, the investigators hope to learn if cervical facet joint steroid injections are beneficial in the subset of patients with MRI findings consistent with facet joint synovitis.


Eligibility Criteria:
Inclusion Criteria:

* at least 18 years old
* Patient who will be getting a neck cortisone shot for pain that has been there for at least 4 weeks
* A specific MRI finding (increased Short Tau Inversion Recovery signal) around 1 or more of the joints in the neck

Exclusion Criteria:

* Those receiving disability, worker's compensation, or are involved in litigation related to their pain.
* Those unable to read English and complete the assessment instruments.
* Those unable to attend follow up appointments
* The patient is incarcerated.
* Grade 2 or greater spondylolisthesis at the involved or adjacent segments.
* History of prior posterior cervical surgery. Anterior cervical surgery is not an exclusion criteria.
* Progressive motor deficit, and/or clinical signs of myelopathy.
* Prior neck cortisone shots within the past 6 months.
* Possible pregnancy or other reason that precludes the use of fluoroscopy.
* Allergy to contrast media or local anesthetics.
* BMI\>35.
* Systemic inflammatory arthritis (e.g., rheumatoid arthritis, ankylosing spondylitis, lupus).
* Active infection or treatment of infection with antibiotics within the past 7 days.
* Chronic widespread pain or somatoform disorder (e.g. fibromyalgia).
* Addictive behavior, severe clinical depression, or psychotic features.
Introduction of the Surgical Safety Checklist

In January of 2007, the World Health Organization's (WHO) World Alliance for Patient Safety initiated a project called "Safe Surgery Saves Lives" to identify minimum standards of surgical care that can be universally applied across countries and settings. Through a two year process involving international input from surgeons, anesthesiologists, nurses, infectious disease specialists, epidemiologists and others, the WHO created a surgical safety checklist that encompasses a simple set of surgical safety standards that can be used in any surgical setting. Each safety step on the checklist is simple, widely applicable, and measurable. The Surgical Safety Checklist was piloted in 8 hospitals around the world and results demonstrated a significant decrease in death rate and postoperative complications.

This study proposes to introduce an adaptation of the Surgical Safety Checklist for an ambulatory care surgical program and to assess the efficacy of its adaptation and implementation on staff safety attitudes and patient outcomes. Specific ambulatory-based items will be included in the checklist and patient outcomes will be assessed using the Institute for Health Improvement's Perioperative Surgical Outcomes Tool which will also be adapted for use for the ambulatory setting as well as routine follow up phone calls with patients on the 1st postoperative day.


Eligibility Criteria:
Inclusion Criteria:

* ambulatory surgical patient

Exclusion Criteria:

* in-patient or any patient who is planning to be admitted to hospital postoperatively
PROTECT : Pacing to Protect Heart for Damage From Blocked Heart Vessel and From Re-opening Blocked Vessel(s)

To determine whether the application of ventricular pacing can protect the human heart from damage resulting from a myocardial infarction

To determine whether the application of ventricular pacing can protect the human heart from damage resulting from a myocardial infarction

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of acute myocardial infarction, requiring PCI within 2 to 6 hours following symptoms
* Total occlusion of a coronary artery with reference vessel diameter \>or= 3mm

Exclusion Criteria:

* Thrombolitics
* Severe bradycardia requiring cardiac pacing
* Previous PCI or CABG
* Recent stroke or CV surgery
* Recent major surgery or trauma
* Clinical and hemodynamic unstability
* Implanted CRM device
* Evidence of previous MI
* Diabetes using rosiglitazone or other fibrates
* Permanent AF
* Mechanical tricuspid valve
* Pregnancy
* Exclusion for MRI
* Incapability of participating in exercise test
Evaluation of a Non-invasive Device to Measure Blood Pressure and Difference in Pulse Pressure (dPP) Intraoperatively

Dynamic parameters like pulse pressure Variation (PPV) , synonymous: difference in pulse pressure (dPP), can predict fluid responsiveness reliably (Marik PE et al, Crit Care Med 2009; 37:2642-7). An arterial line is required for assessment of dPP. On a modified Penaz technique, a non-invasive measurement device is now available commercially. In this study, the reference technique based on arterial measurement and a respiratory variation monitor (Pestel G et al, Anesth Analg 2009; 108:1823-9) was compared to the non-invasive device a clinical setting. At defined time points, systolic, diastolic, mean arterial blood pressure and dPP were compared using Bland-Altmann Analysis (Bland JM, Altman DG, Lancet 1986; 1: 307-10)


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 and \< 80 years old
* Written informed consent obtained
* Patients scheduled for elective urological or abdominal surgery procedures in supine position
* qualifying for arterial line

Exclusion Criteria:

* pregnancy
* cardiac insufficiency (NYHA 4, EF \< 25 %)
* coronary artery disease (CCS 4)
* coagulopathy
* symptoms of infection or sepsis
* malignant hyperthermia
* absence of sinus rhythm
* BMI \> 30
* M. Raynaud
Clinical Use of Pathogen Reduced Red Blood Cell Suspension

The aim of the study is to evaluate the effectiveness and safety of the application of pathogen inactivated RBC suspension in children with oncological and hematological diseases.

Assumed scope of study:

The study will include 70 patients: 35 patients to the test group, who will get transfusions with pathogen-inactivated red blood cell suspension; 35 patients to the control group, who will get transfusions with irradiated red blood cell suspension.

Methods:

* Selection of patients suitable to participate in the study.
* A few days before the assumed transfusion date, select/prepare a red blood cell suspension corresponding to ABO and Rh systems, with no more than 14 days of storage. Conduct direct antiglobuline test (DAT), indirect antiglobuline test (IAT) and test for individual compatibility with the patient's serum.
* Before performing transfusion (on the day of transfusion), determine the initial indices of the patient (Hb, Hct, Haptoglobin). Determine the red blood cell suspension indices (Hb, Hct, extracellular potassium, free hemoglobin, hemolysis percentage).
* Perform transfusion. Evaluate the presence and severity of post-transfusion reactions and complications.
* Measure the patient's Hb, Hct, potassium and haptoglobin levels the next day after the transfusion.
* Perform DAT 3 to 5 five days after the transfusion.
* Perform IAT 2 to 3 weeks after the transfusion.
* Evaluate the need for transfusions over the follow-up period (30 days).

Eligibility Criteria:
Inclusion Criteria:

Patients who need supportive transfusion therapy with RBC suspension

Exclusion Criteria:

* Active bleeding
* Sepsis/severe infection (any infectious disease requiring pressor agents, infusion and respiratory support)
* Positive DAT and / or IAT before transfusion
* Double populations for ABO and RH blood group antigens
* Severe hepatomegaly/splenomegaly
* Patients receiving chemotherapy (at the time of need for transfusion)
* Patients receiving antithymocyte immunoglobulin and also within 7 days after its completion
* Patients requiring transfusion of only irradiated blood components
Beneficial Effect of Adding Pentoxifylline to Processed Semen Samples on ICSI Outcome in Infertile Males

To evaluate the effect of pentoxifylline used in preparation of semen samples that will be used for ICSI in infertile men complaining of mild and moderate asthenozoospermia (i.e. cases which does not need motility enhancement prior to ICSI) in comparison to semen samples without pentoxifylline preparation on the outcome of ICSI.

The primary outcome measures were the number of oocytes retrieved, the number of oocytes injected, number of oocytes fertilized, fertilization rate, number of embryos and their quality (G1: good embryos, G2: fair embryos and G3: bad embryos), number of embryos transferred (ET), number of embryo sacs, embryo implantation rate, pregnancy rate and abortion rate for all 3 groups and pregnancy rate and abortion rate for both group (I) and group (II).

Eligibility Criteria:
Inclusion Criteria:

* seeking ICSI for infertility

Exclusion Criteria:

* Pyospermia, presence of antisperm antibodies. Azoospermia, severe male factor, severe asthenozoospermia. Past history of orchitis. Patients who received empirical treatment for asthenozoospermia e.g. oral Pentoxifylline, l-carnitine or antioxidants during the past 3 to 6 month. Diabetics, hypertensives or patients with any other chronic systemic illnesses. Wife's age more than 35 years. Low antral count. Presence of any ovarian factor contributing to infertility e.g. polycystic ovaries.
Results of Adjunctive Intraoperative Bevacizumab Injection on Trabeculectomy Outcome

The purpose of this study is to evaluate the adjunctive effect of intratenon Bevacizumab on the result of trabeculectomy in primary term of intraocular pressure (IOP).

Prospective interventional clinical trial

Single center, outcome assessor-masked, active control, randomized controlled trial

Eligibility Criteria:
Inclusion Criteria:

* Primary open angle glaucoma with primary mmc-trabeculectomy indication

Exclusion Criteria:

* combined phacoemulsification with trabeculectomy
* no more than 6 month of cataract surgery before trabeculectomy
* revised trabeculectomy
* active uveitic glaucoma
* neovascular glaucoma
* par planar vitrectomy
* conjunctival surgery
* allergy to bevacizumab or mitomycin C
* ischemic heart disease
* cerebrovascular disease
* renal failure
* liver failure
Prospective Trial of the Bilevel Positive Airway Pressure (by Boussignac) in Emergency Department of Non-invasive Patients Presenting With Acute Hypercapnic Respiratory Failure

The purpose of this study is to determine whether the new Boussignac-system of non-invasive ventilation is as good as the conventional non-invasive System in patients presenting with acute hypercapnic respiratory failure.


Eligibility Criteria:
Inclusion Criteria:

* 7,25 ≤ pH ≤ 7,35
* PaCO2 ≥ 45 mmHg

Exclusion Criteria:

* pH \< 7,24
* incapable of collaboration
Multicenter Evaluation of Patients Using LATITUDE Monitoring System

The Multitude is a registry of patients who receive commercially available CIEDs that remotely communicate through the LATITUDE monitoring system and transfer data to a central database.

The registry is designed to constitute a shared environment for the collection, management, analysis and reporting of clinical and diagnostic data, adopted by a network of European scientifically-motivated physicians who use rhythm management diagnostic and therapeutic solutions from Boston Scientific in their clinical practice.

The Multitude study will facilitate the sharing of scientific proposals within a large network of researchers, and it will allow researchers to record the experience with medical devices throughout the device and patient lifecycle.


Eligibility Criteria:
Inclusion Criteria:

* Subject is willing and capable of providing informed consent to collect/store/process personal health information by the sponsor or such consent is provided by a legally designated representative, if required by local law or regulation.
* Subject is:

  1. prospectively scheduled for receiving a device monitored through the LATITUDE monitoring system
  2. retrospectively enrolled after having received a device monitored through the LATITUDE monitoring system

Exclusion Criteria:

* Subject foreseen not to be followed at the enrolling center for at least 1 year after having received the device.
* Subject is receiving a device that is not approved for commercial use at the time of procedure.