cyrilzakka/clinical-trials huggingface dataset:
Idys™ TLIF 3DTi Post Market Clinical Follow-up

The aim of this observational post-marketing study is to provide additional information on the safety and effectiveness of Idys™ TLIF 3DTi at up to 24 months post transforaminal lumbar fusion in usual surgical practice.

The primary endpoint is to evaluate the effectiveness of the Idys™ TLIF (Transforaminal Lumbar Interbody Fusion) 3DTi (Porous Titanium additive manufacturing) by measuring the evolution of the rate of fusion during the postoperative period.

The secondary endpoints are to analyze the safety and the patient's benefit of the Idys™ TLIF 3DTi by evaluating several point of view:

* The adverse events related to the surgery;
* The functional improvement between preoperative state and the different follow-up time points using the Oswestry Disability Index (ODI);
* The improvement of back pain between preoperative state and the different follow-up time points using the Visual Analog Scale (VAS) (legs and back);
* The evolution of several radiologic lumbar parameters to assess the correction and its stability.

Eligibility Criteria:
Inclusion Criteria:

* English Speaking patients
* Patient with skeletal maturity
* Patient with

  * degenerative disc disease at one or two levels from L2 to S1 and/or
  * grade 1 spondylolisthesis
* Surgical treatment with Idys TLIF 3DTi interbody fusion device used in conjunction with a posterior fixation system (pedicle screws and rod).

Exclusion Criteria:

* Off-label indications.
* Any medical or surgical condition which would preclude the potential benefit of spinal implant surgery.
* Any patient having a prior fusion at the level to be treated.
* Any patient being vulnerable
* Non-English speakers
Addressing Tobacco, E-Cigarette, and Cannabis Waste

This study tests of effect of brief education and support about tobacco, e-cigarette, and cannabis waste (TECW) on knowledge, beliefs, behavior, and TECW on two college campuses.


Eligibility Criteria:
Inclusion Criteria:

* student at University of California, Davis or California State University San Marcs
* between the ages of 18 and 25
* taking at least one class on the main campus
* at least six months until graduation
* have a smart phone with location services enabled for apps
* regular access to a device with sufficient WiFi
* private space for three remote visits on over the next six weeks and one visit in six months
* willing to have camera on during remote visits

Exclusion Criteria:

* None
Probiotic BIO-25 as a Supplement to Statins for the Treatment of Hypercholesterolemia

The primary objective is to examine whether probiotics given to hypercholesterolemic patients treated with statins, would further decrease LDL-Cholesterol levels.

The secondary objective is to examine whether adding of probiotics to statins would decrease fasting glucose levels and glycolysated hemoglobin


Eligibility Criteria:
Inclusion Criteria:

1) Patients on maximal tolerated dose of conventional statins treated for at least eight weeks on simvastatin 40, pravastatin 40, atorvastatin 40-80 or rosuvastatin 20-40 mg, who failed to achieve target values of LDL-cholesterol according to the European Socety Cardiology guidelines 2012.

Exclusion Criteria:

1. Patients on chronic antibiotic treatment
2. Patients with immune disorders
3. Patients who are not receiving maximal dose of statin therapy or receive combination of statins for dyslipidemia.
4. Patients who experienced myocardial infarction within less than two months.
5. Patients who consume probiotics.
Cobalamin Supply and Metabolism in Healthy Children From Birth to the Age of 12 Months and in Their Mothers (Cbl_Neo)

Introduction: Infants with severe vitamin B12 (cobalamin, Cbl) deficiency can develop severe, sometimes irreparable neurological damage in the first months of life. Neonatal Cbl deficiency is usually secondary and due to low maternal Cbl stores, e.g. in vegan diets or pernicious anaemia. This Cbl deficiency is then often also found in breast milk. In the Austrian newborn screening (NBS) for congenital diseases of the Cbl metabolism, newborns with secondary Cbl deficiency are also frequently discovered. For these, the risk-benefit assessment of the invasive work-up and treatment that follows is complex. Little is known about how Cbl levels in maternal blood relate to those in breast milk and the corresponding levels in the child.

Objective: To investigate the effects of maternal nutrition and maternal Cbl status on neonatal Cbl levels. In the breastfeeding period, the effects of maternal nutrition on breast milk and infant Cbl status will be investigated, as well as their relationship to the maternal and infant microbiome. We hypothesise that adequate Cbl supply in early life is not determined by diet alone, but also by the interactions between diet and microbiome.

Design and methods: Prospective cohort studies of 100 women and their children with measurement of Cbl, methylmalonic acid, homocysteine and other metabolites of Cbl metabolism in umbilical cord blood, maternal blood, dried blood spots and urine from the child at birth. The same parameters are measured in the mother's blood and breast milk after 3 and 9 months; in the child, only measurements of methylmalonic acid in the urine are carried out. A 3-day dietary record is taken from the mother at all measurement times, and from the child at the measurement times of 3 and 9 months. Stool is collected from mother and child at all measurement time points to examine the microbiome relevant to Cbl metabolism. A child development interview will be conducted with mothers by telephone at 12 months of age of their child.

Schedule: The study lasts 2 years with pre- and post-processing. The LKH Bregenz has about 1200 births per year. Assuming a willingness to participate in the study and an enrolment rate of about 20% of the women, a recruitment period of 6 months is planned (enrolment of first participant day 1, last participant end of study month 6; last laboratory parameter measurement end of study month 15; last child development interview study month 18).


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women
* their newborns

Exclusion Criteria:

* children: preterm birth
* children: neonatal disease
* women: disease around birth
* women: multiples pregnancy
Tomotherapy in Locally Advanced Gallbladder and Pancreatic Cancers

SUMMARY

PROJECT TITLE: Concurrent chemo-radiation using Tomotherapy based IMRT in locally advanced Gallbladder and Pancreatic cancers: A Phase II study

SPECIFIC OBJECTIVES:

Primary To assess the radiological response by dose escalated IMRT in locally advanced inoperable gallbladder and pancreatic cancers.

Secondary

1. To assess the resectability rate with microscopic negative margin (R0).
2. To assess the acute and late toxicities (Number of Participants with Adverse Events as a Measure of Safety and Tolerability)
3. To study the locoregional control in the patients undergoing R0 resection
4. To study overall survival

DESIGN: Phase II study

STUDY POPULATION: All patients of age \>18 years years diagnosed with non metastatic locally advanced inoperable gall bladder and pancreatic cancer

STUDY SIZE: 60 patients

METHODOLOGY: Sixty cases will be screened and taken for study if eligible after taking the informed consent.

Patients will receive radiotherapy using Tomotherapy based IMRT with concurrent chemotherapy Gemcitabine weekly. The response will evaluated at 6 weeks post chemoradiation and if operable will undergo surgery, if still inoperable or metastatic will receive palliative chemotherapy.

PROJECT PERIOD:

Total project period : 3 years Recruitment, Data collection : 2 years Complete analysis of data : 1 year

STUDY SITE: Tata memorial centre

In both gall bladder and pancreatic cancer surgery is the main stay of treatment, but majority of these tumors are inoperable by virtue of adjacent organ infiltration. In this study, inoperable gallbladder and pancreatic cancer patients will be treated with high precision radiotherapy using Tomotherapy delivering higher dose of radiation along with chemotherapy. It is expected that this high dose precise radiotherapy along with chemotherapy will lead to good symptom relief and make some of these tumors operable.

Eligibility Criteria:
Inclusion Criteria:

1. Inoperable locally advanced gall bladder and pancreatic cancer by virtue of vascular encasement of superior mesenteric artery (SMA), celiac artery, hepatic artery, portal vein (PV) or deep hilar invasion precluding R0 resection.
2. Biopsy proven adenocarcinoma
3. KPS \>= 70
4. Age \>18 years
5. Medically fit for chemotherapy
6. Normal hematological, renal and hepatic function (Serum Bilirubin\<3mg/dl)
7. No prior history of treatment with radiation or chemotherapy.
8. Patient willing and reliable for follow-up.

Exclusion criteria

1. Any other malignancy in any site.
2. Expected survival \< 3months.
3. Severe co-morbid conditions ( Severe cardiac disorder, severe bronchial asthma, severely compromised liver function, psychological disorder)
4. Malignant ascitis.
5. Distant metastases by clinical examination or by imaging/whole bodyPET scan.
Active Nutrition Program on Weight Loss

The study will evaluate the impact of the Active Nutrition 60-day program from USANA on weight loss and related measures, such as body composition, physical appearance/body shape, perceived wellness, and biochemical markers of health (e.g., blood lipids, glucose, insulin).

To date, no controlled study exists to evaluate the impact of the Active Nutrition program from USANA on weight loss and related measures, such as body composition, physical appearance/body shape, perceived wellness, and biochemical markers of health (e.g., blood lipids, glucose, insulin). Therefore, the purpose of the proposed study is to evaluate the Active Nutrition weight loss program on body weight and related variables in a sample of overweight and obese men and women. Subjects in the Active Nutrition group will be compared to a control group of men and women following their standard diet, for a period of 60 days.

Eligibility Criteria:
Inclusion Criteria:

* body mass index 28-39.9 kilograms per square meter
* weigh less than 500 lbs
* able to fast overnight (greater than 10 hours)

Exclusion Criteria:

* tobacco user
* diagnosed with type 1 or 2 diabetes
* diagnosed with liver disease
* adversity to fiber or protein supplements
* allergic to any of the ingredients
* taking a weight loss dietary supplement or adhering to a weight loss plan for the month prior to or during the study
* consumption of alcohol within 24 hours of study visit
* consumption of caffeine within 24 hours of study visit
* strenuous exercise within 24 hours of study visit
* self-reported active infection or illness
* pregnant or lactating
The Relationship Between Serum PSA Levels and WBC, Delta Neutrophil Index (DNI) and Other Hematological Parameters

Purpose:

To find the correlation between hemogram parameters and Delta Neutrophil Index(DNI) and Serum PSA in patients presenting with the diagnosis of acute prostatitis.

Material-Metod: Serum PSA levels and hemogram parameters of patients who came to the urology outpatient clinic in January 2018 and May 2022 and were diagnosed with prostatitis were collected retrospectively.

Serum PSA levels and hemogram parameters of patients who came to the urology outpatient clinic in January 2018 and May 2022 and were diagnosed with prostatitis were collected retrospectively.

WBC, neutrophil, lymphocyte, neutrophil-lymphocyte ratio, delta neutrophil index (DNI), PLT, RDW, and MPV values were determined in the Hemogram Parameters. Serum Total PSA and Free PSA values of the patients were also checked. Urine culture, urinary ultrasound, and antibiotic therapy

Eligibility Criteria:
Inclusion Criteria:

Acute prostatitis Male

-

Exclusion Criteria:

Prostate cancer Chronic prostatitis Other Urinary infections,

-
A Sample Collection Study to Validate the Astute Medical NephroCheck Test in Critically Ill Subjects at Risk for Acute Kidney Injury

The objective of this sample collection study is to collect blood and urine samples. This study is observational and will have no impact on the medical management of the subject.


Eligibility Criteria:
Inclusion Criteria:

* Males and females 21 years of age or older
* Subjects must be enrolled (first study-specific sample collection) within 24 hours of ICU admission
* Subjects enrolled from ED or Floor must be admitted to the ICU within 24 hours of enrollment
* Subjects enrolled in the ICU must have been admitted to the ICU or transferred into the study ICU from another ICU no more than 24 hours prior to enrollment
* Expected to remain in the ICU for at least 48 hours after enrollment
* Use of indwelling urinary catheter as standard care expected for at least 48 hours after enrollment
* At least one of the following acute conditions documented within 24 hours prior to enrollment
* Respiratory SOFA score of ≥ 2 (PaO2/FiO2 \<300)
* Cardiovascular SOFA score of ≥ 1 (MAP \< 70 mm Hg and/or any vasopressor required
* Subject (or authorized representative) able and willing to provide written informed consent for study participation.

Exclusion Criteria:

* Special populations including women with known pregnancy, prisoners or institutionalized individuals
* Previous renal transplantation
* Known moderate to severe AKI prior to enrollment (e.g., RIFLE-I or RIFLE-F/ AKIN 2 or AKIN 3
* Already receiving dialysis (either acute or chronic) or in imminent need of dialysis at the time of enrollment
* Known infection with human immunodeficiency virus (HIV) or active hepatitis (acute or chronic)
* Subjects with a history of Chronic Kidney Disease (CKD) without a baseline serum creatinine value (baseline within 6 months of enrollment)
Comparison of the Quality of CPR by Lay Rescuers With and Without Feedback Devices

Comparison of various methods to improve the quality of CPR

Even for paramedics and emergency physicians, the resuscitation of patients with cardiac arrest remains a challenge. Previous studies have shown that the cardiac output varies widely even among professional helpers. This is especially due to some very different mean frequencies of cardiac compression wich vary from 60 to 160/min for paramedics. Aim of this study is to investigate whether the use of feedback-devices during cardiac-pulmonary resuscitation (CPR) can lead to an improvement of the cardiac output and may improve survival.

For this, we examine the impact of different feedback-methods on the frequence-variety on manikin by lay rescuers. Overall, we compare three different devices for feedback during CPR. The subjects for this study are lay rescuers who perform a 5 minute chest-compression-only CPR.

Eligibility Criteria:
Inclusion Criteria:

* lay rescuers
* \>18 years
* \<60 years

Exclusion Criteria:

* professional rescuers
* pregnancy
Safety and Efficacy Trial of MTX101 2mg for the Acute Treatment of Migraine in Adults

The goal of this clinical trial is to learn if drug MTX101 works to treat acute migraine attacks in adults. It will also learn about the safety of the drug MTX101. The main questions it aims to answer are:

Does the drug MTX101 lower headache pain for participants and the need to use a rescue medication? What side effects, if any, do participants have when taking the drug MTX101? Researchers will compare the drug MTX101 to a placebo (a look-alike substance that contains no drug) to see if the drug MTX101 works to treat acute migraine attacks.

Participants will:

Take the drug MTX101 or a placebo to treat 1 migraine attack with each treatment.

Visit the clinic twice and have one phone call over a 4 week period for checkups and tests.

Keep a diary of their symptoms and the number of times they use a rescue medication.

Subjects enrolled in the study will be randomized to receive investigational product (MTX101 2mg or placebo), to be taken as soon as they have a migraine headache that reaches moderate to severe intensity. Subjects will take a single dose of either active or placebo to treat one migraine headache. Rescue medication should not be taken until at least 2 hours post study medication dose.

The subject will have a telephone check up within 72 to 120 hours after treatment of the first migraine headache.

The subject will treat a 2nd moderate to severe migraine at least 48 hours after the first treated migraine headache.

The subject will return to the clinic for re-evaluation within a 4 week period from the start of the study.

Eligibility Criteria:
Key Inclusion Criteria:

1. Male or female aged 18 to 65 years at the time of consent.
2. Onset of migraine headache before age 50.
3. History of episodic migraine headache starting at least 1-year ago with or without aura.
4. Has a minimum of 4 monthly migraine days and not more than 10 migraine days per month.
5. Able to distinguish pain related to migraine attacks from tension-type and cluster headache attacks.
6. Able to understand and provide signed informed consent.
7. Willing and able to comply with all scheduled visits, treatment plan, and other study procedures.

Key Exclusion Criteria:

1. No more than a total of 15 headache days per month.
2. Use of more than 2 migraine preventive medications.
3. Current diagnosis of glaucoma.
4. Use of opioids or barbiturates more than 4 days/month, triptans or ergots 10 or more days/month, or simple analgesics (e.g., aspirin, NSAIDs, acetaminophen) 15 or more days/month in the 3 months prior to Visit 1.
5. Current diagnosis of any post-traumatic headaches, medication overuse headaches, new daily persistent headache, trigeminal autonomic cephalgia (e.g., cluster headache), painful cranial neuropathy or daily headaches.
6. Vaccination within less than 7 days from the Screening or plans to get a vaccine during the study or within a week after final study dose.
French Validation of the AdT-Physio Scale

The goal of this observational study is to translate and validate the Adt-Physio scale in French, and to validate on a large number of patients the French translation of the Adt-Physio scale as a tool for evaluating adherence and perception of the intervention of a physiotherapist in patients with cystic fibrosis.

participants will have to answer the French trans-AdT scale, the Brief Cope and GSES questionnaire.

Cystic fibrosis is one of the most frequently encountered rare genetic diseases. In 2022, this pathology affected 7,743 people in the French population, i.e. 3% more than in 2021. Previously, this fatal disease only granted a few months of life to child carriers. Today, the median age at death is over 40 years old. The adult population suffering from cystic fibrosis has thus become more numerous than the pediatric population. Among existing treatments, respiratory and musculoskeletal massage physiotherapy occupies a central place in patients' lives. However, the level of adherence to massage physiotherapy is low among young adults (16 to 21 years old) compared to other types of treatments. Faced with epidemiological changes and the daily burden that this chronic pathology represents for those affected, therapeutic adherence should be a major concern for physiotherapists. Indeed, a low level of adherence would increase treatment failures, the risk of premature death, episodes of exacerbations and hospitalizations and would thus reduce quality of life. It is therefore crucial to have means of assessing this parameter in patients with cystic fibrosis. The AdT physio self-assessment questionnaire, validated in Spanish since 2020, has shown clinical validity and reliability for Spanish-speaking patients. Thus, a version of this scale translated and validated in French would offer physiotherapists a relevant tool allowing them to evaluate therapeutic adherence and the perception of their interventions with French-speaking patients suffering from cystic fibrosis.

Eligibility Criteria:
Inclusion Criteria:

The subjects recruited are patients with cystic fibrosis, over 18 years old, without a lung transplant and able to answer the questionnaires.
Study Evaluating Safety & Immunogenicity of rLP2086 Vaccine in Healthy Toddlers

A study to assess the safety of an investigational meningitis vaccine in toddlers and their immune response to it.


Eligibility Criteria:
Inclusion Criteria

* Aged 18- to 36-months
* Healthy male or female subjects

Exclusion Criteria

* Prior vaccination with a serogroup B meningococcal vaccine
* Prior history of any invasive meningococcal disease
Effect of Atelocollagen Injection in Patients With Calcific Tendinitis

Assess the clinical outcomes using atelocollagen injection in patients with calcific tendinitis.

Suitable participants based on the selection/exclusion criteria are randomly assigned to either the case group or the control group. Consent is given right before the procedure.

Case group (Atelocollagen injection group): Ultrasound-guided barbotage followed by lidocaine and atelocollagen injection.

Control group (Lidocaine injection group): Ultrasound-guided barbotage followed by lidocaine injection."

Clinical outcomes will be assessed with functional scores on 6 months after injection.

Eligibility Criteria:
Inclusion Criteria:

1. Patients in whom calcification of 5mm or more is observed in plain radiographs.
2. In cases where concomitant medication is administered continuously during the clinical trial period, patients who have verified the exact prescribed medication taken within the last week and agreed to maintain the same amount throughout the study period.
3. Individuals who have agreed to participate in this study and have given written consent themselves.

Exclusion Criteria:

* Patients with a medical history of infectious arthritis, rheumatoid arthritis, tumors, or fractures.

  * Patients with hypersensitivity.

    * Patients with a history of anaphylactic reactions.

      * Patients with ongoing autoimmune diseases or a past medical history of such diseases, either in the patient or their family members.

        * Patients who are allergic to transplants. ⑥ Patients who are allergic to porcine (pig) proteins.

          ⑦ Patients deemed unsuitable for this trial based on the judgment of the trial administrator, such as those with mental illnesses.

          ⑧ Patients who have received intra-articular steroid or other injection treatments within one month prior to the procedure decision.

          ⑨ Patients who are on concomitant medications that include oral steroids.