cyrilzakka/clinical-trials huggingface dataset:
Transcutaneous Spinal Cord Stimulation for Chronic Low Back Pain

As a leading cause of disability worldwide, chronic low back pain (cLBP) represents a significant medical and socioeconomic problem with estimated health care spending of $87 billion/annually. The efficacy of dorsal column electrical stimulation to inhibit pain was first described over 50 years ago. Since then, several large clinical trials have investigated the therapeutic potential of electrical spinal cord stimulation (SCS) and found that over 70% of patients with intractable pain had over 50% pain relief after 1 year of treatment. Thus, SCS is a promising therapeutic intervention that has superior patient outcomes when compared to traditional modalities for the treatment of cLBP. To date, SCS for treatment of cLBP has been delivered via epidural electrodes, requiring neurosurgical implantation. Although, the implantable stimulators have a low rate of adverse events, secondary complications associated with surgical intervention still occur.Transcutaneous spinal cord stimulation (tSCS) is a rapidly developing non invasive neuromodulation technique in the field of spinal cord injury. Its application potentiates lumbosacral spinal cord excitability enabling motor functions, (e.g. independent standing, postural control) in patients with chronic complete motor paralysis. Given that epidural and transcutaneous SCS activate similar neuronal networks, tSCS for cLBP treatment may be advantageous due to its non-invasive nature which may also allow for a mass market production and rapid patient availability if tSCS is proven efficacious. In this pilot study we will establish the feasibility of tSCS to acutely improve patient reported outcomes (pain scores) and several objective measures, including sit-to-stand biomechanics, neurophysiological and neuroimaging outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Low back pain
* Able to get in and out of chair unassisted
* No changes in medication within 2 weeks of study enrollment
* Stable dose of their medications within 2 weeks of study enrollment

Exclusion Criteria:

* Body Mass Index (BMI) \> 28
* Hardware in the spine from prior surgeries
* Presence of epidural stimulation leads
* Presence of any additional neuromuscular pain unrelated to spinal condition
* Intolerance to any form of electrical stimulation, such as neuromuscular stimulation in the past
* Lack of perceived endurance to go through multiple experimental assessments in one day/complete the study which may take up to 3 hours
* Changes in medications within 2 weeks of study enrollment
* Moderate/severe depression (Beck Depression Inventory score \> 20)
Rivet PVS Therapy in Group 2 PH-HFpEF

This clinical investigation is a prospective, multicenter, non-randomized, open-label, Early Feasibility Study to evaluate the safety, performance, and initial clinical efficacy of the Rivet PVS therapy in patients with symptomatic pulmonary hypertension.


Eligibility Criteria:
Select Inclusion Criteria:

* Age ≥ 18 years
* Prior diagnosis of Group 2 PH due to HFpEF, with the following resting hemodynamic criteria confirmed in the past year by right heart catheterization

  a. mPAP ≥ 25 mmHg at rest or mPAP/CO slope \> 3 mmHg/L/min during incremental exercise
* Confirmation of the following hemodynamic criteria during supine exercise

  a. PCWP ≥ 25 mmHg, or PCWP/CO slope \> 2 mmHg/L/min
* Chronic symptomatic heart failure documented by the following:

  1. NYHA HF Class II with history \> II, or Class III, or ambulatory Class IV
  2. ≥ 1 HF hospitalization, or healthcare facility with IV diuretics or intensification of oral diuresis for HF within 12 months, or NT-pro BNP value \> 400 pg/mL in normal sinus rhythm or \> 750 pg/mL in atrial fibrillation in past 6 months
* Ongoing stable guideline directed medical therapy (GDMT) for HF and medically optimized per treating HF physician according to current ACCF/AHA guidelines that is expected to be maintained without change for 6 months (excluding diuretic dosage changes for HF optimization within 90 days of the Index Procedure)
* 6MWD ≥ 150 m

Select Exclusion Criteria:

* Any therapeutic intracardiac intervention within the last 30 days
* PH Group 1, 3, 4 or 5
* Mean RAP \>12 mmHg by RHC at rest on room air
* Right ventricular dysfunction, defined as one or more of the following

  1. Greater than moderate RV dysfunction as assessed by TTE and/or MRI
  2. RV FAC \< 35%
  3. TAPSE \< 14 mm via TTE
  4. RV size severely enlarged compared to LV size as estimated by TTE and/or MRI
* Severe tricuspid valve regurgitation
* Peak systolic pulmonary arterial pressure \> 80 mmHg by RHC at rest while awake
* Mean pulmonary arterial pressure \> 50 mmHg by RHC at rest while awake
* PVR \> 6 Wood units at rest while awake on room air or exercise PVR \> 2 Wood Units
* Left ventricular ejection fraction \< 50%
* Severe heart failure, defined as one or more of the following:

  1. ACC/AHA/ESC Stage D heart failure, non-ambulatory NYHA Class IV HF
  2. If BMI \< 30, Cardiac Index \< 2.0 L/min/m2
  3. If BMI ≥ 30, Cardiac Index \< 1.8 L/min/m2
  4. Requires continuous intravenous inotropic infusion
  5. Requires mechanical circulatory support
  6. Currently on the cardiac transplant waiting list
* Chronic renal dysfunction defined as one or more of the following:

  1. Currently requiring dialysis; OR
  2. eGFR \< 35 mL/min/1.73 m2 by the CKD-Epi equation
* Chronic pulmonary disease defined as one or more of the following:

  1. Requires continuous home oxygen therapy
  2. Recent hospitalization for exacerbation within 12 months prior to screening
  3. FEV1 \< 50% predicted
Carpal Tunnel Syndrome and Amyloidosis

Carpal tunnel syndrome has been suggested to be an early sign of amyloidosi. The investigators will evaluate tissue samples obtained from patients undergoing carpal tunnel release surgery for amyloid.

Carpal tunnel syndrome (CTS) can be caused by the deposition and accumulation of misfolded proteins called amyloid and is often an early manifestation of systemic amyloidosis.

Patients with cardiac amyloidosis often have carpal tunnel syndrome that precedes cardiac manifestations by several years, and many patients will have undergone surgery for idiopathic carpal tunnel syndrome since the protein also deposits in the transversal carpal ligament of the hand.

The investigators sought to identify the prevalence and type of amyloid deposits in patients undergoing carpal tunnel surgery and evaluate for cardiac involvement

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing carpal tunnel syndrome surgery

Exclusion Criteria:

* None
Chemotherapy-induced Symptoms in Sarcoma Patients and the Impact of Tumor Burden

Assessments (survey data) in this study are designed to sample the symptom burden of patients undergoing adjuvant and neoadjuvant chemotherapy in the hospital. There will be no change in the treatment plan for these patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are receiving doxorubicin plus ifosfamide (AI)

Exclusion Criteria:

* There is no exclusion criteria
Combined Pharmacotherapies for Alcoholism (Naltrexone/Ondansetron)

This study will compare the effectiveness of ondansetron (Zofran) and naltrexone (ReVia) both alone and in combination in treating Early Onset Alcoholics versus Late Onset Alcoholics. All subjects will received standardized Cognitive Behavioral Therapy. Followup assessments will be completed at 1, 3, 6, and 9 months after treatment.


Eligibility Criteria:
Inclusion Criteria:

* Current diagnosis of alcohol dependence.
* Provide a written informed consent.
* Must weigh within 30% of their ideal body weight.
* Patients must weigh at least 89 lbs. and no more than 342 lbs.
* Good physical health.
* Currently drinking 14 or more alcohol units per week for women and 21 or more alcohol units per week for men in the last 30 days.
* Provide evidence of stable residence in the last month prior to enrollment in the study.
* No plans to move in the nine months after entering the study.
* Literate in English and able to read, understand, and complete questionnaires and follow instructions.
* Willingness to participate in behavioral treatment for alcoholism.

Exclusion Criteria:

* Current psychiatric disorder other than alcohol or nicotine dependence.
* Elevated liver enzymes or elevated bilirubin.
* Severe alcohol withdrawal symptoms which require treatment.
* Serious medical co-morbidity requiring medical intervention or close supervision.
* Severe or life-threatening adverse reactions to medications in the past or during this trial.
* Female patients who are pregnant, lactating, or not adhering to an acceptable form of contraception at any time during the study.
* Received inpatient or outpatient treatment for alcohol dependence within the last 30 days.
* Compelled to participate in an alcohol treatment program for alcohol dependence to maintain their liberty.
* Members of the same household.
* Tuberculosis.
* Current treatment with any medications having a potential effect on alcohol consumption and related behaviors or mood.
* Urine must be free of opiates, cocaine, amphetamines, barbiturates, benzodiazepines, prescription and non-prescription drugs.
* Pyrexia of unknown origin.
Risk Prediction Model for Iodinated Contrast Medium Extravasation

This study aims to develop a risk prediction model for iodine contrast agent extravasation from peripheral veins and to implement this model clinically to establish a risk control management system for iodine contrast agent extravasation.A case-control study design was employed to collect data for model development. The case group comprised patients who experienced iodine contrast agent extravasation during enhanced CT examinations, while the control group included patients who underwent similar examinations without extravasation.

In this study, a retrospective case-control design was utilized to collect data from patients who underwent enhanced CT examinations at our medical center. In line with the nursing management protocols of our center, all cases of iodine contrast extravasation require treatment and follow-up, necessitating the creation of an electronic record for each affected patient. During the establishment of these records, researchers obtained consent from the affected patients to include them in the study. Upon receiving approval, relevant data from the records were extracted for research purposes. For the non-extravasation group, researchers approached eligible patients or their guardians after the examination, explained the study's objectives, and collected pertinent data through Electronic Medical Record System after obtaining informed consent.

The collected data encompass general demographic information (including age, gender, height, and weight), medical history (including conditions such as malignant tumors, chemotherapy treatments, hypertension, and diabetes), and examination parameters (including specific examination items, types of contrast agents, injection dosages, and flow rates). Additionally, the dataset includes venous access details (such as vascular conditions, peripheral venous catheter insertion sites, and catheter models) and environmental factors (such as maximum and minimum temperatures and temperature variations).

Eligibility Criteria:
Inclusion Criteria:

1. Volunteer to participate in this study.
2. Without contraindications such as iodine contrast allergy or hyperthyroidism. -

Exclusion Criteria:

1. There are communication barriers between researchers and patients.
2. Due to critical condition or unstable vital signs, patients should be transferred to relevant clinical departments for treatment or observation immediately after examination.
Patient Satisfaction and Prosthetic Complications of Bar Locator Versus Bar Clip Attachments for Mandibular Two-Implant Overdentures

Purpose: This study evaluated patient satisfaction and oral health-related- quality of life (OHRQoL) with implant overdentures retained with bar locator versus bar clip attachment for mandibular two-implant overdentures. Materials and methods: This study included sixteen edentulous patients. Every patient received new maxillary and mandibular dentures. Two dental implants have been embedded in the mandibular canine areas. The participants were randomly divided into two equal groups: Group I (bar locator): Patients were given overdentures with bar locator attachments, Group II (bar clip): Patients were given overdentures with bar clip attachment. Patient satisfaction (primary outcome) was measured by a visual analog scale (VAS). OHRQoL (secondary outcome) was measured by oral health impact profile (OHIP-14). Questions of VAS and OHIP-14 were evaluated after 3 months.

The aim of this study was to document and report on the prosthetic complications associated with mandibular implant overdentures using bar locator and bar clip attachments. The study aimed to test the null hypothesis that the complications would not differ based on the type of retention (locator or clip).


Eligibility Criteria:
Inclusion Criteria:

* Each patient had sufficient remaining alveolar ridge in the upper and lower jaw to support implants in the lower jaw area
* a minimum length of 11 mm and a diameter of 3.7 mm, as confirmed by cone beam computed tomography.
* patient had a class I jaw relationship
* adequate space between the arches.
* healthy, firm gum tissue.

Exclusion Criteria:

* participants with uncontrolled diabetes,
* heavy smoking
* drinking habits
* temporomandibular joint (TMJ) issues.
Atherogenic Lipoproteins in Ischemic Stroke

Apolipoprotein B (apoB) levels (which encompass all atherogenic lipoproteins, including LDL), Lp(a) levels, and carotid IPH are associated with both first-ever and recurrent ischemic stroke.

This cohort research project is to analyze:

1. Among patients with carotid artery atherosclerosis (stenosis 30-99%), to compare patients with and without IPH, as assessed by magnetic resonance (MR)-Plaque Imaging, in terms of apoB, Lp(a) levels and other cardiovascular risk factors. (IPH is a strong morphological sign of plaque vulnerability / instability and a strong marker of consecutive atheroembolic events).
2. Among patients with carotid artery atherosclerosis (stenosis 30-99%), to assess the risk of first-ever ischemic stroke in relation to apoB, Lp(a) levels, and presence of IPH, after adjusting for the cardiovascular factors (understanding this association can inform primary prevention).
3. Among patients with carotid artery atherosclerosis (stenosis 30-99%) with an ipsilateral ischemic stroke at baseline, to assess the risk of recurrent ipsilateral ischemic stroke in relation to apoB, Lp(a) levels, and presence of IPH, after adjusting for the cardiovascular factors. There will be a sensitivity analysis to assess if the association between Lp(a) and recurrent stroke is stronger in patients \<60 years of age. (understanding this association can inform secondary prevention).

For the first and second aim, there will be a cross-sectional, case-control analysis. For the third aim, i.e. assessing recurrent ischemic stroke, there is prospective follow-up of at least 3 months up to 45 months.


Eligibility Criteria:
Inclusion Criteria:

* Atherosclerotic carotid stenosis, North American Symptomatic Trial Collaborators (NASCET) method 30-99%
* Ability to undergo a neck MR for carotid plaque imaging
* Ability to undergo a follow-up of at least 1-year
* For the prospective, longitudinal part: Hemispheric ischemic stroke or retinal ischemia ipsilateral to the carotid stenosis, with symptom onset within 24 hours (these patients will be followed-up for recurrent ischemic stroke)

Exclusion Criteria:

* Carotid stenosis due to causes other than atherosclerosis (e.g. carotid dissection or post-actinic)
* Contraindication to MRI
* Lack of informed consent
Reversible Portal Vein Embolization Before Major Hepatectomy

The aim of this study is to prospectively evaluate the tolerance and efficiency of a new technique of preoperative selective portal vein embolization (PVE) in patients requiring major hepatic resection.

Portal vein embolization (PVE) is used before major hepatectomy to induce hypertrophy of the future liver remnant (FLR). A non-reversible absorbable material is generally used for embolization, as it provides effective, permanent vascular occlusion. Our team has developed a minimally invasive technique of reversible PVE using gelfoam powder. The aim of this study is to assess the tolerance and efficiency of preoperative reversible selective PVE in patients requiring major hepatic resection. We hypothesize that preoperative reversible PVE allows to similarly increase FLR volume in comparison with classical non-reversible PVE in patients requiring major liver resection with limited FLR.

The hypertrophy ratio after classical non-reversible PVE is evaluated in literature as 13%. We estimated the hypertrophy ratio after reversible PVE as 9% in a previous retrospective study.

The aim of this pilot study is to prospectively evaluate the hypertrophy ratio after reversible PVE.

Primary End Point: Hypertrophy ratio of FLR volume / total liver volume between the baseline and after PVE, assessed by computed tomography scan volumetry 4-6 weeks after PVE.

Eligibility Criteria:
Inclusion Criteria:

Patient aged between 18 and 80 years

* Patient requiring major liver resection (at least 3 segments)
* PVE indication decided in a multidisciplinary meeting
* Patients who are able to understand and follow instructions and who are able to participate in the study for the entire period
* Patients must have given their written informed consent to participate in the study after having received adequate previous information and prior to any study-specific procedures
* Patient affiliated to the French National Social Security System

Exclusion Criteria:

* American Score of Anesthesiologist (ASA) \> 3
* Extensive Portal vein or hepatic vein thrombosis
* Patient not covered by social security service
* Patient under guardianship
* Patients with a medical disorder, condition, or history of such that would impair the patient's ability to participate or complete this study in the opinion of the investigator.
* Patients who have already had anaphylactic or anaphylactoid reactions during the injection of iodinated contrast medium (edema of Quincke...)
* Patients with an allergy to pork products During the hospitalization and before the PVE
* Severe renal insufficiency (glomerular filtration rate ≤ 30mL/min eg calculated based on the Cockcroft formula).
* Pregnant women, or breast feeding women, or women with childbearing potential not using a combination of condoms and a safe and highly effective contraception method during the participation to the research (hormonal contraception with implants or oral contraceptives, or intrauterine devices).
Implication of a Mobile Team of Palliative Care and Reality of the Palliative Approach in the Units

The aim of the study is to estimate the impact of the implication of a Mobile Team of Palliative Care (EMSP) on the palliative strategy in the units with concerned patients. The Mobile Team of Palliative of Foch hospital Care was created in March, 2011.


Eligibility Criteria:
Inclusion Criteria:

* Patients died between July, 2013 and September, 2014 and for which at least one opinion of the EMSP was required

Exclusion Criteria:

* None
S&B Heat Stress Pilot Protocols

The purpose of this study is to develop a heat stress program for the construction industry and evaluate its feasibility and appeal.


Eligibility Criteria:
Inclusion Criteria:

* employed at S\&B
* work more than 20 hours a week

Exclusion Criteria:

* severe chronic disease (e.g. severe pulmonary or cardiovascular disease
* history of severe heat stroke
* use of a pacemaker
* any medical issue which would render the participant unable to wear a chest monitor and cooling vest.
Effects of Aerobic Exercise on Gut Microbiota

In the present study, we seek to elucidate the effects of aerobic exercise on fecal microbiota following the aforementioned no exercise control group and two doses of aerobic exercise training (the exercise training spans \~24 wks) in a cross-sectional sample.

We will collect ancillary data for the ongoing Examination of Mechanisms of exercise-induced weight compensation (E-Mechanic; RCT; Martin CK and Church TS Co-PI's; R01 HL 102166) to investigate the independent aim and hypothesis of this pilot and feasibility (P \& F) grant examining if there are differences in colonic microbial populations from a fecal sample following supervised and controlled aerobic exercise.

The proposed study seeks to better understand the role of colonic microbial populations as a mechanism of change in body weight during aerobic exercise. E-Mechanic is examining the effects of 2 tightly controlled and supervised doses of aerobic exercise, and a no-exercise control group, on energy balance and body weight over 24 wks in overweight and obese persons. The two aerobic exercise doses were: 1) 8 kcal/kg of body weight/week (KKW) (\~900 kcal/wk) and 2) 20 KKW (\~2250 kcal/wk) compared to a no exercise control group. The low dose of exercise (8 KKW) represents the American College of Sports Medicine (ACSM) recommendation for overall health and the higher dose (20 KKW) the recommendation for weight loss and weight loss maintenance.

Aim 1 To investigate if colonic bacterial populations differ between the exercise groups and the healthy living control group following aerobic exercise.

It is hypothesized that participants in the exercise group will have different bacterial populations than those in the healthy living control group.

Eligibility Criteria:
Inclusion Criteria:

Participants are overweight or obese (BMI 25 ≥ kg/m2 and ≤ 45 kg/m2), not actively exercising \> 20 min on ≥ 3 days/wk, weight stable, non-diabetic, non-smoker, and not have any major medical disorders including such as HIV, CVD, mental illness
Lactobacillus Plantarum as Therapy for NK-T Cell Deficiency

The etiology of immune-mediated diabetes mellitus (IMD) remains unclear. However, previous studies indicate that autoimmunity may be a result of dysfunction of natural killer T cells (NK-T cells). Newly diagnoses patients with IMD have been shown in our laboratory to have significantly lower NK-T cells than normal controls. Other studies have shown that oral administration of lactobacillus can boost NK-T cell activity in children with HIV without side effects. Our objective is to evaluate the effect of lactobacillus administration on NK-T cell activity in patients with IMD


Eligibility Criteria:
Recently diagnosed (within the last 6 months) patients with immune-mediated (type 1) diabetes
Desensitization Protocol for Highly Sensitized Patients on the Waiting List for Kidney Transplant

The purpose of this study is to determine whether high dose IVIG and B cell depleting agents can be used effectively in highly sensitized wait-listed patients.

HLA sensitization is known to be the most important barrier to deceased donor kidney allocation. Therefore, the investigators need to develop better strategies for managing pre-sensitized patients using desensitization protocol. In this study the investigators will used two kinds of medication for the reduction of circulating antibodies (high dose IVIg, B cell depleting agents) to highly-sensitized patients who are on the waiting list for a deceased donor kidney transplantation. After desensitization, the investigators will check that this treatment can increase their chances of receiving a kidney transplant.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18
* patients who are on the waiting list more than 4 years
* PRA I or II \> 50%

Exclusion Criteria:

* Recent recipients of any live attenuated vaccine(s) within 4 weeks
* Subjects who have received IVIG or B cell depleting agents previously
* Subjects with positive result for viral hepatitis(B,C) or HIV infection
* Subjects with active infection
* Lactating or pregnant females
* Subjects who have history of malignancy in recent 5years
* Subjects who have experience of treatment for the psychiatric problem in recent 6months
* Subjects who have hematologic abnormality (Hb \< 7g/dL, Platelet \< 100,000/mm3, AST/ALT \> 80IU)