cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Mechanical Traction and Spinal Decompression Treatments in Patients With Low Back Pain

Motorized traction and non-surgical spinal decompression treatments are relatively new treatments for which there is insufficient evidence in the literature. In this study investigators aimed to retrospectively compare the effectiveness of these treatments, which are in the field of their routine practice in their clinic.

Low back pain is one of the leading causes of disability worldwide. People with physically demanding jobs, physical and mental comorbidities, smokers, and obese individuals are at greater risk for low back pain. Anatomical structures that potentially nociceptive contributors to low back pain are intervertebral discs, facet joints, and vertebral end plates. It has been determined that nonsurgical treatments are clinically effective in reducing pain and functional improvement in patients with lumbar disc herniation. However, the level of evidence has generally not been highly evaluated, which can be attributed to the paucity of well designed randomized controlled trials. Despite moderate evidence, exercise and traction are recommended. In this study investigators aimed to retrospectively compare the effectiveness of these treatments, which are in the field of their routine practice in their clinic.

01.01.2019-10.11.2022. Investigators planned to examine the records of patients aged 20-75 years who underwent physical therapy with the diagnosis of lumbar discopathy in AFSU FTR Department Physical Therapy Unit. Investigators planned to examine the routine anamnesis examination, treatment card and control evaluation records of the patients made in the FTR outpatient clinic from the automation system of their hospital.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with lumbar disc disorders
* Patients diagnosed with lumbar vertical hernia
* Aged 20-75 years

Exclusion Criteria:

* Patients treated for acute low back pain
* Patients with a history of lumbar surgery
* Patients with Spondylolisthesis or Spinal Stenosis
* Those with inflammatory rheumatic diseases (Ankylosing spondylitis, spondylarthropathy etc.)
* Patients with sequestered hernia
* Patients with insufficient data in the records
Polar Body Biopsy for Preimplantation Genetic Screening

People with infertility undergoing in vitro fertilization (IVF) can test the embryos using a method called preimplantation genetic screening (PGS) before they are implanted in the uterus to possibly increase their chances of having a successful pregnancy. One or more cells are removed from the embryo. The chromosomes inside the cells are then tested to identify normal or aneuploid embryo(s).

The investigators propose to evaluate a test called micro array analysis on the chromosomes of the first polar body. This method tests part of the egg that would normally be lost and may help us choose the embryo most likely to become a healthy baby.

The polar body (PB) technique makes use of the 23 chromosomes contained in the first polar body, a part of the egg that is extruded at ovulation. Normally the first polar body disintegrates. However, it can be salvaged by polar body biopsy prior to this so that the chromosomes within can be analyzed. PB has three distinct advantages over conventional Fluorescent in-situ Hybridization (FISH) analysis. First, the polar body biopsy is performed on the day that the oocyte is retrieved (day 0) rather than day 3 so results are available earlier. Secondly, this methodology does not remove cells from the growing embryo. The polar body biopsy removes genetic material that would otherwise degrade. Finally, microarray analysis evaluates all 23 chromosomes while only 9-10 chromosomes can be studied with FISH analysis.

The investigators propose to perform microarray analysis in 50 IVF/ICSI (intracytoplasmic sperm injection) patients undergoing PGS.

Day 0 ICSI; PB\* Day 1 Day 2 Day 3 Embryo biopsy with FISH or Microarray analysis Day 4 Day 5 Embryo transfer or embryo biopsy with Microarray analysis followed by Embryo Cryopreservation

Polar body biopsies will be frozen and later analyzed, The PB results will remain undisclosed until the end of the study period. PB results will not be used to guide treatment or clinical management. Embryos will be chosen or deselected for transfer solely based on the standard of care treatment aneuploidy screening analysis.

The three specific aims of the project are as follows:

* To determine the efficacy of PB biopsy and analysis by comparing the PB results to the Fluorescent in-situ Hybridization (FISH)/microarray results
* To evaluate the safety of PB by comparing the implantation , miscarriage, pregnancy, and delivery rates
* To determine the error rate of FISH analysis by analyzing the remaining cells in embryos determined to be abnormal by initial FISH/microarray analysis

Eligibility Criteria:
Inclusion Criteria:

1. Are undergoing IVF/Intracytoplasmic sperm injection(ICSI)
2. Are considering preimplantation genetic screening for aneuploidy
3. Are between ages 18 and 42 inclusive (female partner)

Exclusion Criteria:

1. Using sperm from a testicular source
2. Fewer than 10 oocytes retrieved
3. Fewer than 6 oocytes fertilized normally
4. Complete fertilization failure (no oocytes fertilize)
Staccato Loxapine Pulmonary Safety in Patients With COPD

The purpose of this study is to assess the pulmonary safety of 2 doses of Staccato Loxapine within a day in patients with COPD.

To address the possibility that inhalation of loxapine may have adverse pulmonary effects, we studied two 10-mg inhaled doses of loxapine or placebo were given 10 hr apart to subjects with chronic obstructive pulmonary disease (COPD). The objective was to determine the time course and reversibility of pulmonary effects for inhaled loxapine compared with placebo.

Eligibility Criteria:
Inclusion Criteria:

* History of COPD for at least 6 months with pre-bronchodilator FEV1 ≥40% of predicted value and \>15 pack-year history of cigarette smoking.

Exclusion Criteria:

* History of asthma, or any other acute or chronic pulmonary disease.
Spaced Education to Optimize Prostate Cancer Screening

Two memory research findings (the spacing and testing effects) can dramatically improve retention of learning, but they have largely have been ignored by educators. The researchers have developed a novel form of online education (termed 'spaced education') based on these two effects which has been shown in randomized trials to improve knowledge acquisition and boost learning retention. Using prostate cancer screening as an experimental system, the researchers investigated whether spaced education could durably improve clinicians' behaviors, not just their knowledge.


Eligibility Criteria:
Inclusion Criteria:

* Primary care providers (physicians, nurse practitioners, and physician assistants) from the 8 Veterans Affairs (VA) hospitals in the New England region (Veterans Integrated Service Network 1 \[VISN-1\]) were eligible to enroll.

Exclusion Criteria:

* Primary care providers (PCPs) who ordered PSA as a screen for prostate cancer less than 10 times each year were excluded.
Effect of H2 Receptor Antagonist and Proton Pump Inhibitor on the Positivity Rates and Clinical Outcomes of COVID-19

This retrospective cohort study aims to evaluate the effect of proton pump inhibitor (PPI) or histamine-2 receptor antagonist (H2RA) on the clinical outcomes and positivity rates of Coronavirus Disease-19 (COVID-19).

Previous researches on the association between the use of PPI and H2RA and the treatment and prevention of COVID-19 have reported inconsistent findings. This study aimed to evaluate the effect of H2 receptor antagonists and proton pump inhibitors on the clinical outcomes and positivity rates of COVID-19 using the Korean National Health Insurance (NHI) data. This is a retrospective cohort study using the NHI COVID-19 dataset, which includes health insurance data of individuals who underwent COVID-19 PCR test in South Korea. This study aims to evaluate the effect of the use of PPI and H2RA on the positivity rates and clinical outcomes of COVID-19.

Eligibility Criteria:
Inclusion Criteria:

* Individuals who were tested for COVID-19 using real-time reverse transcriptase PCR assay of nasal and pharyngeal swabs

Exclusion Criteria:

* Record of a new prescription of non-steroidal anti-inflammatory drugs (NSAID) within 1 month of the test date
* Patients who died within 48 hours after test.
Short-term Outcome After Ventral Hernia Repair

Hernia repair in sublay technique is widely accepted for ventral hernias, as it appears to be advantageous in terms of complication and recurrence rates. Recently, self-gripping meshes are increasingly used for hernia repair with retromuscular mesh positioning. However, real-life data on the safe use in that specific indication are still lacking. Therefore, this study evaluated short-term postoperative outcome of self-gripping versus conventional non-self-gripping meshes in sublay hernia repair.


Eligibility Criteria:
Inclusion Criteria:

* ventral hernia repair in sublay technique

Exclusion Criteria:

* ventral hernia repair in other technique
Investigating the Physiology of Targeted Theta-burst Neuromodulation

This research seeks to study the physiological effects of theta-burst transcranial magnetic stimulation (TMS) in the brains of healthy controls using functional MRI and spectroscopy.


Eligibility Criteria:
Inclusion Criteria:

* No personal history of neurological or psychiatric disorders

Exclusion Criteria:

* Have had a brain injury or neurological disorder
* Have ever suffered an epileptic fit
* Have any non-removable metal implants
* Drink more than 20 units of alcohol per week on a regular basis
* Currently take any illicit drugs on regular basis
* Likely to be pregnant
* Ever suffered from a serious mental illness such as schizophrenia, severe depression or bipolar disorder
* Currently take any psychotropic medication
Gemcitabine and Oxaliplatin in Treating Patients With Metastatic Pancreatic Cancer

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known whether giving both of these drugs on the same day is more effective than giving them on different days.

PURPOSE: This randomized phase III trial is studying two different schedules of gemcitabine and oxaliplatin to compare how well they work in treating patients with metastatic pancreatic cancer.

OBJECTIVES:

Primary

* Compare the objective response rate in patients with metastatic adenocarcinoma of the pancreas treated with two different schedules of gemcitabine hydrochloride and oxaliplatin.

Secondary

* Compare the clinical benefits and tolerability of these regimens in these patients.
* Compare the progression-free and overall survival of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to the participating center and ECOG performance status (0 or 1 vs 2). Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive gemcitabine hydrochloride IV over 100 minutes on day 1 and oxaliplatin IV over 2 hours on day 2.
* Arm II: Patients receive gemcitabine hydrochloride IV over 100 minutes followed by oxaliplatin IV over 2 hours on day 1.

In both arms, treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed adenocarcinoma of the pancreas

  * Metastatic disease
* Measurable disease (primary tumor or metastasis)

  * At least 1 cm in diameter by spiral CT scan
* No ampulla of Vater carcinoma or biliary adenocarcinoma
* No known brain metastases

PATIENT CHARACTERISTICS:

* ECOG performance status (PS) 0-2 or Karnofsky PS 60-100%
* Life expectancy more than 12 weeks
* Absolute neutrophil count \> 1,500/mm\^3
* Platelet count \> 100,000/mm\^3
* Alkaline phosphatase \< 5 times normal
* Bilirubin \< 1.5 times normal
* Creatinine \< 1.5 times normal
* No pre-existing neuropathy
* No unstable or uncontrolled pain
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No serious cardiovascular disease
* No serious respiratory disease
* No uncontrolled or persistent hypercalcemia
* No psychological, familial, social, or geographical condition that would preclude study treatment
* No other active malignancy

PRIOR CONCURRENT THERAPY:

* No prior chemotherapy or radiotherapy
* No concurrent corticosteroids
The Effect of Mediclore as an Anti-adhesion Agent and Safety in Full-endoscopic Spine Surgery: a Preliminary Study

The goal of this clinical trial is to compare efficacy and safety of Mediclore as anti-adhesion agent in patient who undergo endoscopic lumbar discectomy. The main question\[s\] it aims to answer are:

* efficacy (patient-reported outcomes, epidural fibrosis)
* safety (complications) Participants will received Mediclore at surgical site after finish the operation in experimental group and normal saline in control group.

Researchers will compare to see if experimental group have better patient-reported outcomes (PROs) after surgery with no different in complications rate.

This study is a randomized clinical trial arrange in King Chulalongkorn Memorial Hospital. Participant will be randomly assigned into 2 groups by computer-generated sequence. Patients based-line characteristic data, patient-reported outcomes (VAS back/leg, ODI and EQ-5D) and a results of straight leg raising test will be collected. Participant will undergo a endoscopic lumbar discectomy by a singer spine surgeon. In experimental group, 1.5 CC. of Mediclore (poloxamer-based thermosensitive anti-adhesive agent) will be applied in after finish the operation. In control group normal saline 1.5 CC. will be applied instead.

Participants will proceed to regular follow-up protocol which include 1, 3 and 6 months visit at out-patient department. All of the PROs and a result of a straight leg raising test will be collected at each visit. MRI will be performed at 3 month after the surgery. The amount of epidural fibrosis will be evaluated according to Ross's method.

Eligibility Criteria:
Inclusion Criteria:

* Lumbar disc herniated patients
* Failed proper conservative treatment more than 6 months

Exclusion Criteria:

* Previous history of lumbar spine surgery OR lumbar epidural steroid injection
* Infection OR malignancy
* Allergic to any given components
* Lactation and pregnency
Phase 1 Study of LOP628 in Adult Patients With cKit-positive Solid Tumors and Acute Myeloid Leukemia

LOP628 is an antibody-drug conjugate (ADC) consisting of an anti-cKit humanized IgG1/κ antibody conjugated to a maytansine payload via a non-cleavable linker.

LOP628 provides an opportunity to target cKit overexpressing tumors.


Eligibility Criteria:
Inclusion Criteria:

For patients with solid tumors:

* documented cKit-positive neoplasms
* Patient must have progressive disease as defined by any of the following:
* SCLC: patient has progressed after at least 1 prior therapy
* GIST : patient has relapsed or has refractory disease, and no further approved effective therapeutic option exists
* Patients with other cKit-positive solid tumors: patient has progressed after at least one prior line of therapy and no further approved effective therapeutic option exists
* Patient has measurable disease as per RECIST v1.1 criteria

For patients with AML:

* documented cKit-positive acute myelogenous leukemia
* Consent to newly obtained bone marrow aspirate
* Patient must have progressive disease defined as relapsed or refractory non-PML AML following standard therapy or for whom no effective therapy exists.
* Blast count \< 50,000/mm3

Exclusion Criteria:

For patients with solid tumors:

* Patient has central nervous system (CNS) metastatic involvement unless the CNS metastases have been previously treated and the patient is clinically stable and on a stable dose of corticosteroids for at least 4 weeks prior to enrollment.
* Patient has the presence of other clinically significant hematologic, cardiac, respiratory, gastrointestinal, renal, hepatic or neurological conditions.
* Patient has a history of serious allergic reactions, which in the opinion of the investigator may pose an increased risk of serious infusion reactions
* Patient has been previously treated with cKit directed antibodies
* Pregnant or nursing women

For patients with AML:

* Patient has received prior allogeneic bone marrow transplant (BMT).
* Patient has the presence of other clinically significant cardiac, respiratory, gastrointestinal, renal, hepatic or neurological disease
* Patient has a history of serious allergic reactions, which in the opinion of the investigator may pose an increased risk of serious infusion reactions
* Patient has been previously treated with cKit directed antibodies
* Pregnant or nursing women
Efficacy and Safety Study of Frexalimab (SAR441344) in Adults With Nonrelapsing Secondary Progressive Multiple Sclerosis

The purpose of this randomized, double-blind, placebo-controlled, parallel group study is to determine the efficacy of frexalimab in delaying the disability progression and the safety up to 36 months double-blind administration of study intervention compared to placebo in male and female participants with nrSPMS (aged 18 to 60 years at the time of enrollment). People diagnosed with nrSPMS are eligible for enrollment as long as they meet all the inclusion criteria and none of the exclusion criteria. Study details include:

* This event-driven study will end when the target number of 6-month cCDP events is achieved, and the study is expected to last 43 months from randomization of the first participant to the common study end.
* The number of scheduled visits will be up to 25 (including 3 follow-up visits) with a visit frequency of every month for the first 6 months and then every 3 months.


Eligibility Criteria:
Inclusion Criteria:

* Participant must have a previous diagnosis of RRMS in accordance with the 2017 revised McDonald criteria.
* Participant must have a current diagnosis of SPMS in accordance with the clinical course criteria revised in 2013 endorsed by an Adjudication Committee.
* Participant must have documented evidence of disability progression observed during the 12 months before screening. Eligibility will be analyzed by an Adjudication Committee.
* Absence of clinical relapses for at least 24 months.
* The participant must have an EDSS score at screening from 3.0 to 6.5 points, inclusive.
* Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
* For patients eligible to be treated with siponimod: 1) does not tolerate it due to side effects or safety reasons, or 2) has failed siponimod treatment due to perceived lack of efficacy, or 3) has declined siponimod treatment.

Exclusion Criteria:

* The participant has a history of infection or may be at risk for infection.
* The presence of psychiatric disturbance or substance abuse.
* History, clinical evidence, suspicion or significant risk for thromboembolic events, as well as myocardial infarction, stroke, and/or antiphosholipid syndrome and any participants requiring antithrombotic treatment.
* History or current hypogammaglobulinemia defined by values below the lower limit of normal (LLN).
* A history or presence of disease that can mimic MS symptoms, such as, but not limited to neuromyelitis optica spectrum disorder, systemic lupus erythematosus, Sjogren's syndrome, acute disseminated encephalomyelitis, and myasthenia gravis.
* The participant has sensitivity to any of the study interventions, or components thereof, or has a drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study.
* The participant was previously exposed to frexalimab.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Adaptive Auditive Cueing As a Therapy for Freezing of Gait in Parkinson Patients

The first goal of the study is to investigate whether an algorithm can reliably detect Freezing of Gait (FOG) in Parkinson patients based on participant gait data generated by a pressure insole. The second goal is to investigate whether Auditive Cueing (AC) based on such a detection reduces the frequency and length of FOG episodes in those participants.

The study will be conducted per Good Clinical Practice principles.


Eligibility Criteria:
Inclusion Criteria:

* must have more than 1 FOG episode/day
* must be patient in Ziekenhuis Oost Limburg (ZOL)

Exclusion Criteria:

* not able to speak Dutch
* cannot give informed consent (mental health)
Topical 0.01% Atropine for the Control of Fast Progressing Myopia

Myopia prevalence has dramatically increased worldwide in recent years in the general population and among children. Progressive myopia increases gradually with growth until the age of 20-25 years. At the same time, there is a remarkable increase in the prevalence of severe myopia (more than -6 diopters). Severe myopia is associated with many complications, which can lead to blindness. There is thus an increase in the number of myopic patients in general, and severe myopic patients in particular.

The management of myopia and its complications is therefore a major public health issue.

All the means likely to slow the evolution of myopia (thus to limit the prevalence of strong myopia) must be developed to limit the consequences. 0.01% Atropine seems to be a drug with a great interest to slow down the progression of myopia.

The aim of the present study is to evaluate the efficacy at 1 year of 0.01% atropine (1 drop per day administered for 1 year) on the reduction of fast progressing myopia in children aged 4 to 12, compared to a control group (instillation of a placebo).


Eligibility Criteria:
Inclusion Criteria:

Children from 4 to 12 years

* Myopia from -1 to -6
* Fast progressing myopia (\>0.75 diopter / year)
* Informed consent obtained

Exclusion Criteria:

Astigmatism \> 1.5 diopters

* Anisometropia \> 2 diopters
* Concomitant pathology of anterior or posterior segments
* Other ocular diseases (Ocular inflammation, strabismus ...)
* Atropine hypersensitivity or allergy