cyrilzakka/clinical-trials huggingface dataset:
Toxicity Genetic Determinants and Response to Azacitidine and Venetoclax in AML

The purpose of this research is to see how certain genetic variations relate to side effects and outcomes experienced while receiving treatment with azacitidine and venetoclax.

This is a prospective pilot study of the association of SNPs and venetoclax levels with toxicity and response to azacitidine plus venetoclax (Aza/Ven) as well as pharmacogenomics and venetoclax levels in patients with newly diagnosed AML determined to be unfit for intensive induction. Newly diagnosed AML patients over 18 years old who receive Aza/Ven as standard of care will be eligible for this study. Buccal swabs for SNPs and pharmacogenomic analysis will be collected at baseline. Venetoclax peak and trough levels will be obtained during SOC Aza/Ven treatments. Participants will be recruited initially at AHWFBCCC locations.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent and HIPAA authorization for release of personal health information.
* Age ≥ 18 years of age at the time of enrollment
* Confirmed diagnosis of AML
* Planned initial treatment with azacitidine and venetoclax
* Ability to read and understand the English and/or Spanish language
* As determined by the enrolling investigator, ability of the participant to understand and comply with study procedures for the entire length of the study

Exclusion Criteria:

* None
Injection of an Autologous A2M Concentrate Alleviates Back Pain in FAC-positive Patients

A cartilage degradation product, the Fibronectin-Aggrecan complex (FAC), has been identified in patients with degenerative disc disease (DDD). Alpha-2-macroglobulin (A2M) can prevent the formation of the G3 domain of aggrecan, reducing the fibronectin-aggrecan G3 complex and therefore may be an efficacious treatment. The present study was designed to determine 1) the ability of autologous concentrated A2M to relieve back pain in patients with LBP from DDD and 2) the ability of FAC to predict the response to this biologic therapy.

24 patients with low back pain and MRI-concordant DDD had prospective evaluation. Oswestry disability index (ODI) and visual analog scores (VAS) were noted at baseline and at 3- and 6-month follow-up. Primary outcome of clinical improvement was defined as patients with both a decrease in VAS of at least 3 points and ODI \>20 points. Molecular discography and delayed FAC analysis and injection of platelet poor plasma at the time of the procedure. Patients with FACT-positive assays were significantly more likely to show improvement in their VAS and ODI at follow-up.

Objectives: A cartilage degradation product, the Fibronectin-Aggrecan complex (FAC), has been identified in patients with degenerative disc disease (DDD). Alpha-2-macroglobulin (A2M) can prevent the formation of the G3 domain of aggrecan, reducing the fibronectin-aggrecan G3 complex and therefore may be an efficacious treatment. The present study was designed to determine 1) the ability of autologous platelet poor plasma (PPP) with concentrated A2M to relieve back pain in patients with low back pain (LBP) from DDD and 2) the ability of FAC to predict the response to this biologic therapy.

Study design/setting: Prospective cohort

Patients: 24 patients with low back pain and MRI-concordant DDD

Methods: All patients underwent lavage for molecular discography and delayed FAC analysis and injection of autologous platelet poor plasma (PPP) rich in A2M (Cytonics Autologous Protease Inhibitor Concentrate, APIC) at the time of the procedure. ANOVA with Bonferonni correction for multiple comparisons was performed.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or greater with a history of low back pain complaints primarily dictated by pain with associated sensory symptoms and/or low back pain for 6 months or more who had failed expectant management with NSAIDS, activity modification, and/or physical therapy.
* MRI that demonstrated signs of degenerative disc disease at one or more levels with a Pfirrmann grade of II to IV.
* Age from 18 to 65 with axial back pain of at least 6 months duration.

Exclusion Criteria:

* Patients with a history of oral or injected corticosteroid medication within a three month period prior to disc injection.
* Chronic medical conditions associated with metabolic or inflammatory disorders (insulin-dependent diabetes mellitus, severe coronary artery disease, rheumatic or autoimmune diseases) were excluded from the study.
Depakote ER Plus an Atypical Antipsychotic Vs. an Atypical Antipsychotic Alone in the Treatment of Schizophrenia

The purpose of this study is to assess the 14-day and 12-week safety and efficacy of Depakote ER used in combination with either olanzapine or risperidone versus antipsychotic monotherapy with olanzapine or risperidone for the treatment of schizophrenia.


Eligibility Criteria:
KEY INCLUSION CRITERIA:

* Acute exacerbation of schizophrenia as defined by: subject recently hospitalized or is in the process of being admitted to a hospital or an acute care inpatient psychiatric treatment facility; and has a PANNS Total score of 70 or greater at the time of screening and at randomization based on a 1-7 point scale; and has a score on any two of the four items from psychosis cluster of the BPRS (extracted from the PANSS) that correspond to the positive symptoms (hallucinatory behavior, unusual thought content, conceptual disorganization and suspiciousness) totaling 8 or greater; and has a total of 6 or greater on one of the following two pairs of items from the BPRS (extracted from the PANSS): hostility and uncooperativeness or excitement and tension.
* Current DSM-IV-TR diagnosis of schizophrenia as confirmed by the SCID
* Positive response to antipsychotics in the previous 2 years

KEY EXCLUSION CRITERIA:

* Current diagnosis of schizoaffective disorder, drug-induced psychosis, manic episode or major depressive episode.
* At the time of screening, has been hospitalized for more than 14 days for the current episode
* Has ever taken clozapine
* Has had more than 3 psychiatric hospitalizations in the previous 6 months or has had more than 8 weeks of psychiatric hospitalization in the previous 12 months
* Has serious violent, homicidal, suicidal ideation
* Has received depot medications fluphenazine decanoate and/or haloperidol decanoate within 2 or 4 weeks prior to randomization respectively
* Urine toxicology screen is positive for phencyclidine (PCP), opiates, cocaine or amphetamines
* History of alcohol or substance dependence within the past month
* Has taken any valproate product for a psychiatric indication within the previous 30 days
* Has received an investigational drug within the last 30 days
Laparoscopic Gastric Plication Compared With Laparoscopic Sleeve Gastrectomy

The study must be performed in 100 patients suffering from morbid obesity, the procedure will be performed under general anesthesia doing two or three layers of suture to achieves gastric imbrication until transform the stomach to a sleeve. The patients will be followed during the time for 6 month, 1 year, two years and 5 years.

The patients will be selected with BMI more than 40, the operation will be primary between 18 to 60 years old. The patients will be informed about the procedure and different options. The patients will be in admission board for two or three days and any event will be recorded. the follow up will be recorded by the nurse, the surgeon and the dietitian, laboratory parameter includes CBC, T4,T3, TSH, ferrum, transferrin, ferritin, vit. B12, SMA, lipids, The end point will be the EBW achieved and events occurred.

Eligibility Criteria:
Inclusion Criteria:

* BMI 40 or more
* Age between 18-60 years old
* ASA score 1-2

Exclusion Criteria:

* BMI less than 40
* Severe illness
* Psychiatric disorders
Standard or Short-course Vonoprazan Non-bismuth Triple Therapy or High-dose Dual Therapy Versus Rabeprazole-bismuth Quadruple Therapy for Primary Helicobacter Pylori Eradication

The goal of this clinical trial is to compare eradication rates of Helicobacter pylori in patients aged 18-70 years with first infection. The main questions it aims to answer are:

* Main indicators: the eradication rate of Helicobacter pylori for eradication.
* Secondary indicators: symptomatic relief rate at 2 weeks after treatment and 4 weeks after the end of treatment; compliance and adverse reactions during treatment.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-70 years, regardless of sex; chronic gastritis, peptic ulcer or dyspeptic symptoms, clear Hp infection (positive 13C-urea breath test); voluntary Hp eradication treatment; women of childbearing age are required to use a medically desirable form of contraception during the trial and for 1 month after the trial.

Exclusion Criteria:

* Have contraindications to the study drug or are allergic to the study drug; have taken a PPI within 2 weeks and an antibiotic or bismuth within 4 weeks; pregnant and lactating women; and Have undergone upper gastrointestinal surgery; refluse to sign the informed consent document.
Symbicort Turbuhaler 30/60 Special Clinical Experience Investigation for Long-term Use for Chronic Obstructive Pulmonary Disease (COPD) Patients

The purpose of the investigation is to confirm the safety and efficacy in long-term use of Symbicort Turbuhaler in patients with Chronic obstructive pulmonary disease (COPD) under the post-marketing actual use.

Symbicort Turbuhaler 30/60 Special Clinical Experience Investigation for long-term use for COPD patients

Eligibility Criteria:
Inclusion Criteria:

* Among patients treated with Symbicort Turbuhaler due to chronic obstructive pulmonary disease(COPD), those who received the drug for the first time.
Examination of Musculoskeletal System Problems, Pain and Quality of Life Related to Working Conditions in Chiropractors

This research aims to investigate musculoskeletal problems and pain, as well as their effects on the quality of life, arising from the working conditions of chiropractors in their workplaces. Additionally, it is intended to conduct a detailed analysis of working conditions in chiropractors' work environments to identify existing problems, establish the cause-and-effect relationship between musculoskeletal problems, pain, and these conditions, conduct studies to improve chiropractors' work environments, and demonstrate the positive effects of improving working conditions on the quality of life and professional performance of chiropractors. Within this scope, the physical layout of chiropractors' work environments, ergonomic factors, and workplace conditions will be analyzed. Musculoskeletal problems experienced by chiropractors will be identified, and research will be conducted on pain and musculoskeletal disorders associated with workplace factors. Furthermore, the effects of working conditions on the quality of life of chiropractors will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Male and female physiotherapists between the ages of 25-45, with at least 1 year of chiropractic experience, will be selected

Exclusion Criteria:

* Having practiced chiropractic for less than 1 year.
Cryoablation in Patients With Atrial Flutter

The investigators hypothesized that revealing the incidence of AF following RFA of the CTI and cryoablation PVI reduces incidence of AF following RFA of the CTI.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* ECG documented paroxysmal or persistent AFL
* No prior documented history of AF
* Patient undergoing RFA of the CTI for AFL.
* No indication (other than AFL) for continued anticoagulation with warfarin.
* No existing implantable cardiac device (pacemaker, defibrillator, cardiac resynchronization therapy device)
* Availability of an analog phone line.

Exclusion Criteria:

* a history of atrial fibrillation
* Previous AF ablation procedure
* Congestive heart failure
* Left Ventricle ejection fraction less than 35%
* Unwillingness to participate
Effectivity of Slackline-Training in Physiotherapy

Slacklines have been established in the last few years as a training equipment in sports such as climbing, skiing and others to increase postural control. Furthermore, slacklines are used in physiotherapy in terms of stabilizing training such as wobbling boards.

However, if slackline training is effective in rehabilitation has not been investigated yet. Therefore, to goal of this study will be to investigate the effectivity of slackline training in physiotherapy compared to a wobbling board with a single tilting axis.

Outcomes will be electromyographic-data and the kinetics of the whole body.

Comparing beginners pre-training (less than 1 hour of slackline training) to post-training (9 times 30 minutes of individual, controlled training) to investigate the effects of balance training on a slackline.

Comparing beginners (less than 1 hour of slackline training) to professionals (more than 100 hours of slackline training) to investigate differences in balance strategies.

Comparing professionals during slacklining under two different conditions of their visual anchor: fix vs. moving. This to investigate the role of the visual system during balance reactions.

Comparing slackline training versus a demanding training standing-on-1-leg. We do compare Y-balance-performance, performance on the MFT challenge disc, each compared with simultanousely recording body Sway (lower trunk) with SwayStar.

Muscle activity will be investigated by absolute amplitude (mV) and frequency to get an idea of which muscle fibers are acting during the task and how the activation pattern may change through motor learning.

Body kinematics should show movement strategies especially differences in roll and pitch control of the body.

Eligibility Criteria:
Inclusion Criteria:

* young healthy, 18-30 years old
* small operations on muscle-skeletal-system on upper extremities
* birth control pill

Exclusion Criteria:

* any actual injuries on lower extremities
* injuries on lower extremities less than one year back
* operations of muscle-skeletal-system at shoulder/neck, trunk/pelvis and lower extremities
* fear of falling
* any medications
* cardiac pacemaker or cardiac arrhythmia
* pregnancy
* skeletal anomaly
* appendicitis less then 2 years back
Efficacy Evaluation Of Great Occipital Nerve Electrical Stimulation On Rebound Headache

SENGO-CAM study is a sham-controlled simple blind trial which aim is to study the efficacy of great occipital nerve stimulation (GONS) associated with medication withdrawal in the treatment of medication overuse headache occurring in migraine patients.


Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years old
* migraine patient with medication overuse headache by non specific analgesics according to the ICHD-II diagnostic criteria
* failure of outpatient withdrawal
* Signature of informed consent.
* Affiliation to French national health and pensions organization

Exclusion Criteria:

* pregnancy (positive pregnancy test at pre-study) and breast-feeding
* patients with medication overuse headache by specific antimigraine treatment (triptans or/and ergot derivatives) according to the ICHD-II diagnostic criteria
* previous surgical treatment targeting great occipital nerves
Incretin Effect in Lean and Obese Subjects

The incretin effect is markedly reduced in patients with type 2 diabetes. Data support the notion that this deficiency is a consequence of the diabetic state. However, the impact of insulin resistance on the incretin effect in obese individuals who uphold a normal glucose tolerance (NGT) despite their insulin resistant state remains to be elucidated. The primary aim of the present study is to evaluate the separate impact of one of the cornerstones of type 2 diabetic pathophysiology, namely insulin resistance, on the incretin effect in lean and obese patients with type 2 diabetes and in two matched normal-glucose tolerant groups of healthy control subjects.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with type 2 diabetes for at least 3 months
* Normal blood hemoglobin
* Informed consent

Exclusion Criteria:

* Liver disease
* Diabetic nephropathy
* Treatment with medication that can not be stopped for 12 hours
Phase 1 Study to Assess the Safety and Tolerability of TAT4 Gel in Healthy Volunteers

This Phase 1, randomized, placebo-controlled, double-blind, healthy volunteer study tested the safety, tolerability, and plasma pharmacokinetics of two different concentrations of TAT4 Gel administered once daily to 50 cm2 of skin for 14 days.


Eligibility Criteria:
Inclusion Criteria:

* Men and women 40-70 years old
* Healthy volunteers
* Provision of informed consent

Exclusion Criteria:

* History of skin hypersensitivity
* Abnormality on screening assessments
Second Open Label Extension to Bridging Study CTBM100C2303

This was an open-label, single arm (uncontrolled) study in participants suffering from cystic fibrosis, who have completed their study participation in CTBM100C2303 and extension study one CTBM100C2303E1 (all visits), who were proven infected with Pseudomonas aeruginosa at enrollment into CTBM100C2303.


Eligibility Criteria:
Inclusion Criteria:

* Completed all visits in study CTBM100C2303 and CTBM100C2303E1, and visit 11 of study CTBM100C2303E1 took place not more than 5 days before enrollment into this study.
* Confirmed diagnosis of cystic fibrosis participants with P. aeruginosa infection.
* Forced Expiratory Volume in one second (FEV1) at screening (at start of study CTBM100C2303) must be between 25% and 80% of normal predicted values.

Exclusion Criteria:

* Any use of inhaled anti-pseudomonal antibiotics between the termination of the trial CTMB100C2303E1 and the enrollment into this study.
* Known local or systemic hypersensitivity to aminoglycosides or inhaled antibiotics.
Telemedicine to Improve Use of Therapeutic Hypothermia in Rural Settings

This pilot intervention trial will assess the feasibility of a live consultation between community hospital providers and tertiary care providers employing a novel teleconsult platform, Maine Neonatal Encephalopathy Teleconsult (Maine NET), on the time to initiation of therapeutic hypothermia (TH) for 35 infants born in community hospitals in Maine compared with matched historical controls. Community hospital providers and tertiary care center provider satisfaction with the Maine NET platform will also be assessed. The hypothesis is that immediately available expert assessment via a teleconsult platform will promote earlier implementation of TH and be associated with high levels of provider satisfaction.

The study will recruit a total of 125 infants from the participating centers and anticipate that 35 of these subjects will be treated with therapeutic hypothermia and be utilized for the comparative analysis to historical controls. Not all infants recruited and provided a Maine NET consultation will be treated with TH and to have an adequate sample size to make statistical comparisons with historical controls we need to enroll more than 35 participants to ensure 35 have been treated with TH for the comparative analysis.

In a secondary qualitative study, clinicians who completed Maine NET consults through the above clinical trial were interviewed about their experience with the consult. This secondary study will recruit up to 20 clinicians who completed a consult in this clinical trial.

Eligibility Criteria:
Inclusion Criteria:

Infants included in this study will be born at a community hospital, will be in either high or moderate risk, will be younger than 6 hours of age at the time of the consultation and the decision will have been made to treat with TH. High risk infants will be defined as an umbilical cord pH of less than or equal to 7.0 or 5 minute APGAR score of less than or equal to 5 or a need for resuscitation (including respiratory support or chest compressions) or an abnormal exam (which may include flaccid tone, poor suck reflex or poor response to stimulation) or seizures at less than 6 hours of life. Moderate risk infants will be defined as an umbilical cord pH of less than or equal to 7.2 but greater than 7.0 or 5 minute APGAR score of less than 7 but greater than 5 or a perinatal event (such as placental abruption, uterine rupture, cord prolapse, or fetal-maternal hemorrhage) or an abnormal exam (which may include a hyper-alert state).

Exclusion Criteria:

Infants older than 6 hours at the time Maine NET is requested and infants for whom TH is not an appropriate therapy (e.g. due to premature birth or moribund status) will be excluded.
Feasibility of Integrating Indirect Calorimetry (IC) Technology in Primary Care

The purpose of this study is to evaluate the feasibility of using indirect calorimetry (IC) within a comprehensive weight reduction program. Will individuals that receive a personalized nutrition program, at baseline, from IC technology respond better to treatment compared to individuals receiving IC technology at three months.


Eligibility Criteria:
Inclusion Criteria:

* BMI greater than 30 kg/m2
* 18-70 years of age

Exclusion Criteria:

* No participation in other weight loss efforts outside study.
* Pregnant or lactating
REgistry of MisOprostol 200 µg Vaginal dElivery System

The design of the study is post-marketing, observational, multi-centre and open-label. The study does not provide treatment; only patients to whom misoprostol 200 µg vaginal delivery system (VDS) is prescribed may be included. All directions for medication usage and patient monitoring are solely at the discretion of the investigator in accordance with their usual practice and must be consistent with the Dutch prescribing information of misoprostol 200 µg VDS. No other (invasive) study-related interventions or measurements are done, other than the procedures routinely performed during induction of labour. No effort is expected from the study subjects. 150 patients from 20 Dutch centres will be included.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of induction of labour in women with an unfavourable cervix, from 36 weeks gestation, in whom induction is clinically indicated
* Decision made to prescribe misoprostol 200 µg VDS according to Summary of Product Characteristics (SmPC)
* Willingness and ability to provide written informed consent

Exclusion Criteria:

* Misoprostol 200 µg VDS is contraindicated according to the SmPC