cyrilzakka/clinical-trials huggingface dataset:
Acupuncture for Back and Neck Pain in an Emergency Room Setting

This study aims to examine the efficacy of an Integrative approach utilizing Acupuncture as an add-on therapy for the treatment back and neck pain in an emergency department setting

Acupuncture is well established as an effective treatment for back pain. The investigators cumulative experience in Asaf Harofeh Medical Center has shown Acupuncture to be an Effective therapy for simple back and neck pain in an ER setting.

This study will examine weather Acupuncture can decrease pain, increase range of motion and decrease anxiety in patients admitted to the Emergency Room with simple back and neck pain without neurological findings. Acupuncture will be performed as an add on therapy on top of analgesic therapy.


Eligibility Criteria:
Inclusion Criteria:

* Adult male and females age 18-60 with acute or sub acute/chronic simple back or neck pain
* Agreed to a physical examination and by an orthopedic physician and X-ray
* Diagnosis of simple back pain with levels of 4\<NRS at least
* Agreed and able to fill pain, anxiety and satisfactory questioners
* Agreed and able to sign informed consent

Exclusion Criteria:

* Fracture, sprain or neurological deficit during physical examination
* Pain scale of NRS\< 4
* Referred or radiating pain
* Active pregnancy
* Active inflammatory arthritis
* History of CVA
* Open wounds
* Acute malignancy with life expectancy of less than 5 years
* Experience with acupuncture treatments
* History of drug addiction
* History of osteoporosis
* Declined or unable to sign informed consent
* Soldiers in active military service
A Study of Ridaforolimus in Non-Small Cell Lung Cancer (NSCLC) Patients With Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Mutations (MK-8669-021 AM1)

This is a randomized discontinuation study of ridaforolimus in patients with advanced NSCLC who have failed at least 1 but no more than 3 prior treatment regimens and who have KRAS mutant lung cancer. Following 8 weeks of open-label ridaforolimus lead-in there will be an assessment of disease status. Patients assessed by the investigator to have stable disease after 8 weeks will be randomized to double-blind treatment with ridaforolimus or placebo. Patients assessed to have partial or complete response will continue on open-label ridaforolimus. Patients assessed to have disease progression will be discontinued from study.

Allocation and Arms Additional Information: All Patients will receive an 8-week

open-label lead-in treatment of ridaforolimus. After this 8 week period patients will be re-assessed for disease status. Patients who are stable after 8 weeks are randomized in a double-blind fashion to continue treatment with ridaforolimus or to a placebo until disease progression. (Those patients who have stable disease but are randomized to placebo may cross-over to open-label ridaforolimus at the time of disease progression.)

Those patients with tumor shrinkage during the open-label lead-in treatment will continue on open-label ridaforolimus, while those patients who have disease progression at 8-weeks are taken off-study.

Eligibility Criteria:
Inclusion Criteria:

* Patient has histologically confirmed stage IIIB/IV non-small cell lung cancer
* Patient has a documented mutation of the KRAS gene
* Patient has evidence of disease progression following 1 but no more than 3 prior chemotherapy regimens
* A minimum of 4 weeks has passed since the most recent anti-cancer treatment
* Women of childbearing potential must have a negative pregnancy test prior to start of therapy and must use an approved contraceptive method for the duration of the study
* Patient has adequate organ function
* Patient has performance status of \<=2 on Eastern Cooperative Oncology Group (ECOG) performance scale
* Patient is \>=18 years of age

Exclusion Criteria:

* Patient has received more than 2 prior chemotherapy regimens for the treatment lung cancer
* Patient is known to have active brain metastases
* Patient is currently participating or has participated in an investigational drug study within 30 days
* Patient is known to be Human Immunodeficiency Virus (HIV) positive or has a known history of Hepatitis B or C
* Patient has an active infection requiring prescribed intervention
* Patient has newly diagnosed or un-controlled Type 1 or 2 diabetes
Chest U/S in Differentiating Lung Congestion & Pneumonia in Adult Critically-ill Patients and Its Prognostic Impact

This study aim will be to assess the effectiveness of chest ultrasound as a diagnostic and differentiating modality in cases of pneumonia and lung congestion . It also evaluates chests sonography effectiveness in follow-up of patients with pneumonia and lung congestion .

Lung ultrasound (LUS) is used at the bedside in emergency and critical care settings. It is a rapid and low-cost approach that can direct patient care without the use of harmful radiation. The success of this technique depends on its simplicity to discover the sonographic signs which indicate certain lung pathology. These signs include a hyperechoic and sliding line, moving forward and back with ventilation seen 0.5 cm below the rib line and is called the pleural line. The A-profile associates anterior lung sliding with A lines. A lines are horizontal repetition artifacts of the pleural line. The B-profile associates anterior lung sliding with B lines. B lines appear as shining vertical lines arising from the pleural line and reach the edge of the screen.

Several pathological etiologies can fill the alveolar spaces, with fluid (heart failure), pus (pneumonia which is the commonest), blood (pulmonary hemorrhage), and cells (lung cancer).

Other causes of lung consolidation may include atelectasis, pulmonary edema, infarction, and lung cancer. Chest imaging with CT is regarded as the gold standard modality allowing for the diagnosis of pneumonia in earlier stage and with higher sensitivity and specificity. On the contrary, cardiogenic pulmonary edema (CPE) is defined as alveolar transudation caused by elevated pulmonary capillary hydrostatic pressure secondary to increased pulmonary venous pressure with low-protein content in the interstitial tissue of lung as a result of cardiac dysfunction

Eligibility Criteria:
Inclusion Criteria:

* Adult (above 18 years old)
* Both genders
* Patient with symptoms suggestive of pneumonia
* Patient with symptoms suggestive of acute congestive heart failure
* admitted to Critical care unit

Exclusion Criteria:

* Patients with Renal induced lung congestion
HIS Alternative II - UK Site

The study will investigate the feasibility of using direct HIS pacing or left bundle branch pacing (LBB pacing) as an alternative to biventricular pacing in patients with symptomatic heart failure and an ECG with a typical left bundle branch block pattern.

Biventricular pacing has for more than a decade been standard of care for patients with HFrEF, LVEF \< 35%, NYHA II-IV despite optimal medical treatment and an ECG with left bundle branch block (LBBB). However, it is not always ideal because of several drawbacks such as phrenic nerve capture, inability to reach late activated areas and many more. Direct HIS pacing can in many cases capture the left bundle and provide normal electrical activation of the left ventricle but sometimes with high pacing thresholds. Recently direct left bundle branch pacing has shown promise with synchronous activation of the left ventricle at low pacing thresholds.

In the present study the investigators randomize 125 patients in one center to either conventional CRT (45 patients) or HIS/LBB pacing (80 patients). In the HIS/LBB arm, direct HIS-pacing is attempted first but if its not possible or the pacing threshold for capturing the left bundle branch is \> 2.5 V at 1 ms the investigators switch to placing a LBB-lead.

Power calculation for non-inferiority: With the 50 patients in the first His Alternative study (25 Biv-CRT og 25 His-CRT) the investigators observed a fall in systolic volumes of 34% and 46% with a standard deviation of 13-16%. Using these numbers it would take at least 108 patients to be 90% sure that the lower limit of a one-sided 97.5% confidence interval (equal to a 95% two-sided confidence interval) would be over the non-inferiority limit of -10%.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years of age, ischemic or non-ischemic cardiomyopathy with LVEF ≤ 35% assessed by echocardiography, NYHA class II-IV heart failure symptoms despite optimal medical treatment and

  * Either planned new implantation of a biventricular pacing system (CRT-P or CRT-D), where the ECG is with sinus rhythm and a typical left bundle branch block (see definition below)
  * Or planned upgrade of an existing pacemaker or ICD to a biventricular pacing system (CRT-P or CRT-D), where the ECG is with sinus rhythm and a typical left bundle branch block or there has been\> 90% right ventricular pacing from an existing pacemaker for at least 2 months prior to enrollment
* Signed informed consent
* Typical left bundle branch block:

  * QRS width \> 130 msec for women and \> 140 msec for men QS or rS pattern in leads V1 and V2, and mid-QRS plateau phase with or without extras in at least 2 of leads V1, V2, V5, V6, I, and aVL

Exclusion Criteria:

* Existing biventricular pacing system
* Permanent atrial fibrillation
* Severe renal failure with eGFR \< 30 ml/min
* AMI or CABG within the last three months
* The patient does not want to participate
New Antibiotic to Treat Patients With Community-acquired Pneumonia Due to a Specific Bacteria (S. Pneumoniae Pneumonia)

This study will treat patients who have a community-acquired pneumonia that is due to a specific bacteria (S. pneumoniae)


Eligibility Criteria:
Other specific inclusion/exclusion criteria may apply. In order to determine eligibility, further examination by the investigator is necessary.

Inclusion Criteria:

* Patients must have the signs and symptoms of pneumonia, with a chest xray showing a pneumonia.
* The patient must have S. pneumoniae (a specific bacteria) growing in sputum or blood to continue treatment.

Exclusion Criteria:

* Patients cannot have taken more than one day of another antibiotic before entering this study.
* Patients with HIV and a low CD4 count are excluded.
Impact Evaluation of Family Expectations: A Program to Strengthen the Relationships of Disadvantaged Expectant Couples

This study investigates the effectiveness of a program to strengthen the relationships of disadvantaged expectant couples, and to increase co-parenting, father involvement, and economic stability. Couples are randomly assigned to Family Expectations or a control group, and assessed at baseline and one year.

The birth of a child can trigger relationship distress and dissolution. Family Expectations (FE) targets the transition to parenthood as a critical time to help couples focus on family success. Regardless of whether couples are married or unmarried, the goal of FE is to strengthen relationships and advance the well-being of economically disadvantaged couples who are expecting a baby or who are new parents, and to improve the lives of their children. The FE program, including the Becoming Parents (BP) curriculum and supplemental services, is designed to address specific risk factors that affect individual family members and the relationships among them, and to build protective factors that help families avoid, minimize, or manage risks (e.g., individual maladaptation \[mother, father, child\], couple relationship difficulties, parenting difficulties, and economic insufficiency).

A total of 1,355 couples will be randomly assigned to either Family Expectations (n = 813; 60%) or an untreated control group (n = 542; 40%). Once assigned, participants in the study will complete baseline questions by survey. Those assigned to the FE track will be scheduled for services with the FE intervention team and the control group will not receive the FE intervention. Members of the intervention and control groups will be surveyed both before they are randomly assigned and 12 months later. The study will examine if the Family Expectations program is associated with improved outcomes on relationship quality, stability, parenting quality, father involvement, child wellbeing, and hopefulness about employment.

Eligibility Criteria:
Inclusion Criteria:

1. Both partners are willing to participate
2. Partners have a commitment to be together as a couple
3. Both partners are the biological parents of a child in a current pregnancy or of a child born within the past 3 months
4. Fluent in English (study and intervention materials are in English)

Exclusion Criteria:

1. Either or both partners have taken part in Family Expectations services before
Side Effects After Direct-acting Antiviral Treatment

The objective of this study was to assess the incidence of side effects after direct-acting antiviral therapy in patients with chronic hepatitis C virus infection.

Direct-acting antiviral (DAA)-based treatments are today very effective The objective of this study was to assess the incidence of side effects after DAA therapy in patients with chronic hepatitis C virus infection.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Hepatitis C virus infection
* Treatment by direct-acting antiviral combination

Exclusion Criteria:

* HIV coinfection
Correlation MRI - Paraclinical Examination in Sudden Deafness Associated With Vertigo

Acute cochleo-vestibular syndrome or labyrinthitis is characterized clinically by the sudden appearance of a great rotatory vertigo and a unilateral sensorineural hearing loss. In this clinical context, MRI is the examination to eliminate differential diagnoses and to make a positive diagnosis of labyrinthitis (supposedly infectious, immunologic or ischemic). The etiologies described are ischemic, infectious or autoimmune, so the risk factors are very variable (cardiovascular, autoimmune or infectious).

Labyrinthitis has been little studied as a clinical entity in its own right. Indeed, studies mainly focus on sudden deafness with subgroups of patients with vertigo.

The incidence of sudden deafness is of the order of 5 to 20 per 100,000 people per year but is probably under-diagnosed.

The individual and medico-economic consequences are similar to those of hearing loss, with an increased risk of dementia, depression, premature death and an increase in health care consumption.

The objective of the study is to evaluate the performance of MRI (sensitivity and specificity) to localize labyrinthine damage in the presence of an acute cochleovestibular syndrome (presumed to be infectious, ischemic or immunologic) compared to the reference paraclinical examinations for each of the structures.

Eligibility Criteria:
Inclusion criteria:

* Patient of legal age (≥18 years)
* MRI diagnosis of labyrinthitis (presumed to be viral, immunologic, or ischemic in origin) at the University Hospitals (HUS) of Strasbourg between 01/01/2014 and 04/30/2021
* Patient with abrupt deafness (a 30 dB drop in hearing thresholds on at least 3 contiguous frequencies for at least 72 hours) associated with unilateral grand rotatory vertigo of abrupt onset
* Patient with severe unilateral acute onset rotary vertigo with acute unilateral hypoacusis.
* Subject who did not express his opposition, after information, to the reuse of his data for the purpose of this research.

Exclusion criteria:

* Subject who expressed opposition to participating in the study.
* History of chronic vertigo,
* Chronic dizziness,
* Presence of a differential diagnosis on MRI (intra-labyrinthine shwannoma, intra-labyrinthine hemorrhage or complicated cholestatoma)
* History of surgery on the inner or middle ear.
Yttrium Y-90 Radioembolization in Treating Patients With Metastatic Liver Cancer

This clinical trial studies the side effects and best way to perform yttrium Y-90 radioembolization in treating patients with liver cancer that has spread to other places in the body (metastatic). Yttrium Y-90 radioembolization is a therapy that injects radioactive microspheres directly into an artery that feeds liver tumors to cut off their blood supply. Performing yttrium Y-90 radioembolization in a single session may make treatment faster, minimize patient travel, and decrease the overall cost of the procedure.

PRIMARY OBJECTIVE:

I. To evaluate the feasibility and safety of same day yttrium-90 radioembolization planning and treatment angiography.

SECONDARY OBJECTIVES:

I. To determine the patient costs associated with same diagnostic and treatment compared when compared to the standard two session methodology.

II. To determine the time required to perform the mandatory in-room technetium Tc-99m albumin aggregated (99mTc-MAA) imaging and the associated calculations for the lung shunt fraction and treatment 90Y-microsphere activity.

III. To determine the time for delivery of the therapy 90Y-microsphere radioactivity to the angiography suite after the therapy written directive by the authorized user.

OUTLINE:

The first 2 patients enrolled receive standard of care diagnostic and treatment during 2 visits for approximately 6 hours each within 2-4 weeks. During the first visit, patients undergo diagnostic angiography with embolization of potential hepatoenteric collaterals, receive technetium Tc-99m albumin aggregated as a surrogate to the therapy microspheres via catheter, and undergo planar imaging. During the second visit, patients undergo a second angiography and receive yttrium Y 90 resin microspheres via arterial microcatheter. Patients then undergo single-photon emission computed tomography-computed tomography (SPECT-CT) Bremsstrahlung imaging.

All subsequent patients enrolled undergo the same previously described diagnostic and treatment during 1 visit over about 8 hours.

After completion of study treatment, patients are followed up at 1, 3, and 6 months.

Eligibility Criteria:
Inclusion Criteria:

* The ability to understand and sign informed consent
* Any candidate eligible for standard of care Y90 radioembolization for treatment of their primary or metastatic liver tumors

Exclusion Criteria:

* Patients with greater than 50% liver tumor burden
Cadonilimab in the Treatment of Advanced Soft Tissue Sarcoma

The purpose of this study was to evaluate the efficacy and safety of Cadonilimab monotherapy in the treatment of patients with advanced soft tissue sarcoma who have received at least one chemotherapy (including anthracyclines) for advanced diseases (excluding alveolar soft part sarcoma).

After being informed about the study and potential risks, all patients giving written informed consent will undergo a screening period (≤28 days) to determine eligibility for study entry. At week 0, patients who meet the eligibility requirements will be treated with Cadonilimab monotherapy.

Eligibility Criteria:
Inclusion Criteria:

* 1. Written and signed informed consent.
* 2. Male or female, age≥ 18 and ≤ 70 years old on day of signing informed consent.
* 3. Pathologically confirmed unresectable or metastatic soft tissue sarcoma, mainly including Undifferentiated pleomorphic sarcoma/malignant fiber histiocytoma, Alveolar soft part sarcoma, dedifferentiated liposarcoma, fibrosarcoma, Leiomyosarcoma, Anigosarcoma, Synovial sarcoma.
* 4. Patients who have failed at least one chemotherapy (including anthracyclines) in the last 6 months (excluding acinar soft tissue sarcoma).

Exclusion Criteria:

* 1. Prior use of investigational products or devices within 4 weeks prior to the first administration of the study treatment.
* 2. Concurrent enrollment into another clinical study, except the study belongs to investigational, non-interventional studies or the follow-up period of interventional studies.
* 3. Prior exposure to any experimental antitumor vaccines, or any agent targeting T-cell costimulation or immune checkpoint pathways (eg, anti-PD-1, anti-PD-L1, anti-CTLA-4, anti-CD137 or anti-OX40 antibody, etc).
* 4. Active autoimmune diseases;
* 5. History of transplantation;
* 6. Known history of primary immunodeficiency virus infection or known history of testing positive for human immunodeficiency virus (HIV).
Phase II Clinical Trial Scheme of Ganoderma Lucidum Spore Powder for Postoperative Chemotherapy of Osteosarcoma

Osteosarcoma is the most common primary highly malignant bone tumor in children and young people. Incidence rates are bimodal, with the first peak occurring in adolescence and the second peak in patients over 60 years of age. The 5-year survival rate of patients with osteosarcoma is less than 20%. This study aims to improve the prognosis of patients and change the outcome of patients with osteosarcoma.

This project intends to conduct a multicenter, randomized, double-blind, parallel-controlled clinical trial of ganoderma spore powder and doxorubicin combined with cisplatin chemotherapy in the treatment of osteosarcoma patients. The combination therapy of traditional chemotherapeutics has not played a good effect and has large side effects. The Ganoderma lucidum spore powder group is a natural botanical drug that has a good anti-tumor auxiliary effect in regulating the tumor immune microenvironment. The investigators' previous research showed that Ganoderma lucidum spore powder can inhibit the growth and metastasis of osteosarcoma in the body without obvious toxic and side effects, which indicates that this research scheme has strong feasibility.

Eligibility Criteria:
Inclusion Criteria:

- Signed informed consent form

Clinical diagnosis of osteosarcoma

Must be able to swallow tablets

after surgical resection

Exclusion Criteria:

- Symptomatic central nervous system metastases and/or carcinomatous meningitis Known HIV or active hepatitis B/C infection

Active infection requiring systemic treatment

Clinically significant cardiac arrhythmias

Class III or IV Congestive Heart Failure as defined by the New York Heart

Association functional classification system \< 6 months prior to screening

A pregnant or nursing female, or women of child-bearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception

Any condition for which participation would not be in the best interest of the participant

Patients unable to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures or those with severe psychiatric illness/social situations that would limit compliance with study requirements

Patients participating in another clinical investigation at the time of signature of the informed consent