cyrilzakka/clinical-trials huggingface dataset:
: Bacterial Infections in Injecting Drug Users

Bacterial infections in people who inject psychoactive substances

In context of an increase of bacterial infections in people who inject psychoactive substances (PS) all around the world and a lack of available scientific data, the investigators decided to set up a descriptive study on bacterial infection types and determinants in Injection Drug Users (IDUs).

Through a multidisciplinary approach between hospital departments (e.g. infectious diseases, emergency and addictology), the local addiction management and liaison team (ELSA) and the regional addictovigilance center, data were collected on appearance and course of bacterial infections in IDUs hospitalized at Montpellier University Hospital, France.

This study aims to provide medical data in order to better understand those infections and their determinants and provide information for potential future more specific observational studies.

The regional addictovigilance center is a member of the French Addictovigilance Network, which was established to monitor the potential for abuse and dependence of PS, and to provide information on the risk of addiction and advice for public health decision making, under the supervision of the French National Agency for Medicines and Health Products Safety. This surveillance system is principally based on spontaneous reporting by healthcare professionals and patients that is regulated by law. Collected data were extracted from those spontaneous reports (composed by data from the medical file\*, DxCare or notification by medical team). First data were collected in 2012.

In addition, the investigators offered patients to fill in an anonymous questionnaire\*\* on hygiene habits which was not mandatory and had no influence on treatment, and was offered during the ELSA team intervention (questions from the questionnaire are classical risk reduction question on injection and hygiene practices).

Main results are the description of the infections and injection practices. There is no control group per se as all included patients are IDUs and have a bacterial infection. But the investigators infection (such as abscess or skin and soft tissue) and those with a systemic infection. The two groups were established after the recruitment was completed. This comparative analysis is only performed in order to better understand the development of infections. Descriptive and comparative analyses was performed by the Department of Medical Information.

\*Data collected :

* Age
* Sex
* Past history of bacterial infection linked to injection of a psychoactive substance
* HIV and HCV status
* Injected psychoactive substance
* Injection practices (frequency, route, location)
* Diagnosis
* Bacterial analysis
* Treatments and course

  * Hygiene questionnaire (attached file)

Eligibility Criteria:
Inclusion criteria:

* Bacterial infection occurring in injection drug users and linked to injection
* Hospitalized at Montpellier University Hospital

Exclusion criteria:

* No injection
* No use of a psychoactive substance
* Viral or fungal infection
Study on Combined Vaccination With Quadrivalent Influenza Vaccine and 23-valent Pneumococcal Polysaccharide Vaccine

This study is an open-label,single center phase Ⅳ clinical trial of combined immunization with quadrivalent influenza vaccine and 23-valent pneumococcal polysaccharide vaccine.The purpose of this study is to evaluate the safety and immunogenicity of combined immunization with quadrivalent influenza vaccine and 23-valent pneumococcal polysaccharide vaccine in the elderly aged 60 years and above.

This study is an open-label,single center,phase IV clinical trial in the elderly aged 60 Years and above.The experimental vaccines were manufactured by Sinovac Biotech Co., Ltd. A total of 3000 subjects will be enrolled,the safety and immunogenicity of combined immunization were evaluated in 480 subjects,and the Safety observation of combined immunization was evaluated in the extended safety group, which included 2520 subjects.

Eligibility Criteria:
Inclusion Criteria:

* The elderly aged 60 and above;
* The subjects and/or guardians can understand and voluntarily sign the informed consent form;
* Proven legal identity.

Exclusion Criteria:

* Received any circulating seasonal influenza vaccine prior to enrollment;
* Have received any pneumococcal vaccine within 5 years;
* History of severe allergic reactions to vaccines (such as acute anaphylaxis, angioneurotic edema, dyspnea, etc.);
* History of uncontrolled epilepsy and other serious neurological disorders (e.g.transverse myelitis, Guillain-Barre syndrome, demyelinating disease, etc.)
* Fever,acute onset of chronic disease,severe uncontrolled chronic disease or acute disease at the time of vaccination;
* Receipt of other investigational drugs in the past 30 days;
* Receipt of attenuated live vaccines in the past 14 days;
* Receipt of inactivated or subunit vaccines in the past 7 days;
* According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.
rAd-p53 Gene Therapy for Advanced Malignant Thyroid Tumors

This is multicenter, open-label, randomized, active-controled, phase IV study of local direct intra-tumor injection of rAd-p53 monotherapy, with concurrent radioactive iodine , or combination with surgery for treatment of advanced malignant thyroid tumors.

Primary objectives of this study is to determine the efficacy profiles of rAd-p53 intra-tumor injection alone, with with concurrent radioactive iodine, or combination with surgery for treatment of advanced malignant thyroid tumors(stage III or IV) including target lesion complete response rate (LCR) and overall target lesion response rate (OLR), response duration (RD), and progress-free survival (PFS).

The secondary objectives of this study is to investigate overall response rate (OPCR) and overall complete response rate (OCR), overall survival (OS), ECOG, and safety of rAd-p53 monotherapy and combined with radioactive iodine,or surgery.

Eligibility Criteria:
Inclusion Criteria:

1. Advanced stages of thyroid malignant tumors (stage III and VI)
2. At least one target tumor can be injected with study drug, the largest diameter greater than 2 cm
3. Histologically confirmed Oral and Maxillofacial malignant tumors
4. No prior chemotherapy, radiotherapy or biological tumor therapy in 2 weeks
5. Age: 18-85 years old
6. Expected to survive more 12 weeks
7. ECOG:0-2
8. Neutrophils≥1.5×109/L,Platelet≥ 80×109/L, Hb≥80g/L, bilitubin≤2mg/dl,ALT and AST ≤2×institutional upper limit of normal, Cr ≤1.5×institutional upper limit of normal,coagulation tests (PTT and INR) within normal range
9. Subject provided signed informed consent -

Exclusion Criteria:

1. Hypersensitive to study drug
2. Tumor(s) locate very close to important blood vessels and nerves, which affect injection
3. With a coagulation and bleeding disorder
4. With uncontrolled, intercurrent illness including but limited to symptomatic neurological illness, symptomatic congestive heart failure, unstable angina pectoris, significant pulmonary disease or hypoxia, or psychiatric illness
5. Local infection close to injection site or systemic infection
6. Pregnant or lactating
7. Principle investigator consider not suitable
Continuous Wearable Monitor for the Detection and Release of Freezing of Gait.

The proposed system (haptic module and insole device) for daily in-community use that detects the occurrence of freezing of gait (FOG) in people with Parkinson's disease (PD). and triggers external cueing stimuli to unfreeze the individual. The purpose of the overall Phase II study is to: (1) Develop a production ready system, (2) Develop a companion mobile app for the proposed system and refine previously developed FOG detection algorithms, and (3) Validate the proper operation of the system and demonstrate its efficacy through lab and in-community testing. This study will focus on validating the system and demonstrating efficacy through in-community testing.


Eligibility Criteria:
Inclusion Criteria:

* Ability to provide and provision of signed and dated informed consent form.
* Age 45-80
* Diagnosis of idiopathic PD, as determined by a movement disorders neurologist in accordance with the PD Society Brain Bank diagnostic criteria.
* Evidence of presence of freezing gait as a symptom. Determined from combination of clinical examination (observation of freezing) and New Freezing of Gait Questionnaire (NFOG).
* Able to complete a 2-minute walk test at the pre-treatment visit.
* Currently on a stable prescription medication regimen for PD and willing to adhere to the regimen during the study.
* Ability to don and doff the insole and haptic module independently or have daily assistance during the study intervention.

Exclusion Criteria:

* Non-English speaking
* History of musculoskeletal disorders that significantly affect movement of lower limbs as determined at the time of enrollment.
* Other significant neurological disorders that may affect participation or performance in the study.
* Neuropathy at the ankle assessed at the pre-treatment visit using the haptic module.
* Hallucinations
* Non-ambulatory
* Legally Blind
* Symptomatic hypotension
Calprotectin and Ischemia Modified Albumin Serum to Measure Disease Activity in Behçet's Disease

Behçet's Disease activity was evaluated using BD Current Activity Form (BDCAF). Serum calprotectin and IMA concentrations were compared among active BD cases, inactive BD cases and control subjects.


Eligibility Criteria:
Inclusion Criteria:

* new case of Behçet's disease available medical record Well known duration of BD, Well known current treatment used Well known current organ involvement

Exclusion Criteria:

* concomitant autoimmune or auto-inflammatory disorder; acute or chronic infections; cancer; diabetes; heart failure; gestation or up to six months after birth
Effects of Nutraperf Consumption in Runners

Exercise has numerous health benefits. Nevertheless, when exercise duration is \~45 min or longer and intensity moderate to intense, it may induce different troubles, for example: hypoglycemia, peripheral and central fatigue, muscle damages, osteoarticular injuries, inflammation, cardiovascular dysfunctions. Nutritional loading during exercise may prevent and and/or reduce some of these troubles.

In regard of recent data, we proposed a novel energy drink (NUTRAPERF®) to limit deleterious effects of long time exercise in neutral environment (outside temperature between 4 and 25°C) and to improve performance. If performance may be increased by this energy drink during long time exercise, we proposed that it consumption may also improve performance in short and sub-maximal exercise.

So, the purpose of this study is to investigate the effects of the consumption of this novel energy drink on performance during long and short time exercise. Moreover, we studied the effects of this consumption on different metabolic parameters (heart rate, oxygen consumption, respiratory quotient, ventilation, glycemia, lactatemia), on central and peripheral fatigue and on cognitive parameters.


Eligibility Criteria:
Inclusion criteria

* Man aged between 18 and 45 years.
* Regular sportsman (2 to 4 workouts by week since 3 months minimum).
* Be a long-distance runner.
* Be affiliated or beneficial to the National French Security Social.

Non-inclusion criteria

* Any subject who was injured during the three preceding months study.
* Any subject with a history of disease can disrupt the tests. In particular, subjects with pathological conditions placed on the joints of the knee or ankle (sprain repeated problems or patellar ligament) that could hamper measures of force maximum extension and flexion on these joints or illnesses that prevent the exercise of pedalling or running on treadmill (tendonitis, periostitis) will be excluded.
* Any subject who at the same time participates at another medical experiment.
Scintigraphy Study in Healthy Volunteers to Characterize the Performance of ALLN-346 Tablets

The purpose of the study is to understand the gastrointestinal transit time and disintegration behavior of the formulations in vivo in normal healthy volunteers when ALLN-346 formulations are given with light meal or in fasted or other fed states.

This study includes two parts. Part One will evaluate two ALLN-346 formulations, a fast release and a slower sustained release. Subjects will receive a single tablet of each formulation and a capsule of each formulation at separate assessment visits. Subjects will attend a maximum of 4 assessment visits. The primary purpose of this part of the study is to understand the gastrointestinal transit time and disintegration behaviour of the formulations in vivo in normal healthy volunteers when ALLN-346 formulations are given with light meal.

Part Two will involve a second cohort of subjects and will comprise further scintigraphic studies on one or both formulation(s) from Part One in fasted and/or fed states. Subjects will attend a maximum of 4 assessment visits, the number of treatment arms will be decided following completion of Part One.

Eligibility Criteria:
Inclusion Criteria:

* BMI between 18 and 30 kg/m², inclusive.
* Body weight ≥50 kg
* Voluntary written informed consent
* Good general health with no clinically significant and/or relevant abnormalities of medical history or prior to dosing evaluations, including physical examination, vital signs and ECG and screening clinical laboratory results

Exclusion Criteria:

* Current or recurrent disease that could affect the study conduct or laboratory assessments
* History of current or relevant previous non-self-limiting gastrointestinal disorders
* Currently suffering from disease known to impact gastric emptying, e.g., migraine, Type 1 or Type 2 diabetes mellitus
* Untreated hypertension or has hypertension under treatment.
* Diagnosis of an immunosuppressive illness or a condition requiring chronic immunosuppression.
* As a result of a physical examination or screening investigations, and available prior to dosing evaluations, the PMI or medically qualified designee/physician responsible considers the volunteer unfit for the study
* Any contradictions to the gamma scintigraphy procedure
* Measured body temperature \>38°C at screening visit (COVID-19 risk reduction procedure)
Visual Function After Implantation of AcrySof® Toric Lens

The objective of this study is to evaluate the postoperative visual function of Taiwanese patients following bilateral or unilateral AcrySof Toric Intraocular Lens (IOL) implantation.


Eligibility Criteria:
Inclusion Criteria:

* Prospective subjects should be adults and may be of any race and gender, and diagnosed with cataracts.
* Subject must require extraction of cataracts followed by implantation of a posterior chamber intraocular lens.
* All subjects must have between 0.75 - 2.0 Diopter (D) of astigmatism preoperatively as measured by keratometry readings.
* For any second eye surgery in bilateral AcrySof Toric patients, it should be performed at least one week following the first eye implant but no longer than one month after the first implant.

Exclusion Criteria:

* Subjects with pre-existing conditions that could skew the results should be excluded from the Study.
* AcrySof® Toric product inserts under "Precautions" for subject groups that should be excluded from this Study.
Arterial Stiffness in Chronic Kidney Disease

Diurnal variations in the cardiovascular system apparent in healthy individuals, are different in chronic kidney disease patients. Therefore, diurnal variations in arterial stiffness may also differ in chronic kidney disease patients. This study aims to identify and evaluate diurnal variations in arterial stiffness in chronic kidney disease patients and compare them to those in age matched healthy controls.


Eligibility Criteria:
Inclusion Criteria:

* Systolic blood pressure \<160 whether or not on antihypertensive medication
* diastolic blood pressure \<100mmHg whether or not on antihypertensive medication
* Chronic kidney disease stage 2-5

Exclusion Criteria:

* Systolic blood pressure ≥160mmHg
* Diastolic blood pressure ≥100mmhg
* Significant comorbidity (investigator opinion but to include alcoholism and terminal illness)
Effects of PGS2.0 in Patients With Unexplained RPL

50%-60% of the known causes of recurrent pregnancy loss(RPL) are associated with embryonic aneuploidy, such that preimplantation genetic screening (PGS) on embryos acquired by assisted reproductive treatment should improve the rate of pregnancy and live birth in those patients. In dispute though the clinical application of PGS has been, a series of studies show that the new generation of PGS(PGS 2.0), based on blastocyst biopsy followed by whole genome analysis, has significantly improved the clinical outcome of IVF treatment. At present, there is still a need for the evidence of the use of PGS 2.0 in RPL patients, who may benefit from this emerging technology considering the prevalence of genetic abnormalities and the number of transferable embryos in this population.

An earlier single center RCT conducted by our IVF center displayed higher implantation rate, clinical pregnancy rate and ongoing pregnancy rate calculated by per embryo transfer(ET) cycle in IVF/ICSI+PGS group compared with IVF/ICSI group.

This multi-center prospective randomized clinical trial is to provide more data to determine whether the clinical outcomes are significantly improved per treatment cycle such that provide evidence for the application of PGS in RPL patients. Besides, risk factors of PGS outcome are to be analyzed from multi-center data to build a model for prediction of the possible outcomes of PGS and direction of the clinical choice.


Eligibility Criteria:
Inclusion criteria:

1. The couple has experienced two or more failed pregnancies (according to ASRM definition).
2. The karyotypes of both husband and wife are normal (polymorphic chromosomes are considered normal either).

3. Women ages ≥20 and \<38 years old.

Exclusion criteria:

1. the wife has history of the following diseases: a, the history of thyroid disease; b, the history of adrenal diseases; c, the history of sexually transmitted diseases; d, the history of hereditary diseases; e, the history of mental and psychological disorders.
2. the wife has the following uterine abnormalities: a, uterine malformations (uterus unicorns and duplex uterus), untreated septate uterus, adenomyoma, submucous uterine fibroids, endometrial polyps, or intrauterine adhesions (including the history of intrauterine adhesions).
3. the wife has a medical condition that contraindicate ART or pregnancy, including poorly controlled type I or type II diabetes; undiagnosed liver and renal disease or liver and renal insufficiency (based on blood test); deep vein thrombosis; pulmonary embolism; history of cerebrovascular accident; uncontrolled hypertension; cardiac disease; carcinoma; severe anemia; suspicious or undiagnosed vaginal bleeding.
Working Toward Wellness

Working toward Wellness is a telephone care management and outreach monitoring program designed to help Medicaid recipients who are experiencing major depression to enter and remain in evidence-based treatment. To study the effects of Working toward Wellness, individuals receiving Medicaid in Rhode Island who are eligible for mental health services through United Behavioral Health were screened by telephone for depression. Those who were found to have major depression and who agreed to be in the study were randomly assigned. Program participants received intensive monitoring from Master's level clinicians called care managers to facilitate and support clinical treatment. The control group received usual care that included only referrals to mental health treatment providers. The study hypothesis is that telephonic care management would increase visits to mental health professionals and use of appropriate medication, which in turn would reduce depression severity and lead to greater employment and productivity at work.


Eligibility Criteria:
Inclusion Criteria:

* Score of 5 or higher on Quick Inventory of Depression Symptomatology
* receiving Medicaid
* at least one child in household

Exclusion Criteria:

* Bipolar disorder
* alcohol or substance abuse
* currently in active treatment for depression
* receiving Supplemental Security Income
Poor Grade Aneurysmal Subarachnoid Hemorrhage Study Group

Multicentric registry study in order to define outcome, predictors, treatment effects and their modifiers in poor grade aneurysmal subarachnoid haemorrhage patients.

The search for outcome predictors is going to be subdivided into three main research areas:

1. outcome predictors in the emergency department (so called "early brain injury phase").
2. outcome predictors in the neurocritical care unit (so called "delayed brain injury phase").
3. Treatment strategies. Two other areas of research are identified: delayed cerebral ischemia (incidence, treatment, predictors, impact on outcome) and long term follow-up (recent evidences suggest that there may be a non-negligible proportion of poor grade subarachnoid hemorrhage patients who may benefit from substantial improvement at long-term (after 6-12 months of follow-up).


Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to the emergency department because of aneurysmal subarachnoid hemorrhage of poor grade (IV-V) according to the WFNS classification.

Exclusion Criteria:

* Patients younger than 18 years old.
* Pregnant or breast-feeding patients.
* Aneurysmal subarachnoid hemorrhage due to trauma or vascular malformations other than cerebral aneurysms.
Effects of Isolated Lumbar Extension Resistance Training Alone and in Combination with General Exercise and Manual Therapy

This study examines effects of machine-based isolated lumbar extension resistance exercise (ILEX) on paraspinal muscle morphology and function, as well as pain intensity, disability and quality of life in patients with chronic low back pain and radiculopathy related to specific spinal disorders. Current guidelines emphasize the necessity of treating chronic low back pain with integrative, holistic approaches due to its multidimensional nature. At the same time, an increasing number of studies highlight the importance of restoring lumbar muscle function and morphology through targeted training. Regarding ILEX, existing studies already support its clinical value, however, the optimal integration of ILEX with other therapeutic modalities remains unclear.

Two groups will be enrolled in an ILEX protocol (16 weeks, 25 sessions), while one of the groups will additionally participate in general exercise and manual therapy.

After completion of the main program, participants will be given different options to continue the exercise therapy with a reduced frequency (e.g., once per month). After six months, a follow-up assessment will be conducted with all participants to analyze long-term efficacy.


Eligibility Criteria:
Inclusion Criteria:

1. chronic LBP for \> 3 months, defined as pain in the region between the lower ribs and gluteal folds, with or without leg pain
2. seeking care in the facility of the study
3. doctoral assessment indicating symptoms related to disc herniations/protrusions and other specific conditions
4. moderate pain levels at the time of doctoral assessment

Exclusion Criteria:

1. acute low back pain (pain \< 3 months)
2. familiarity with the device (usage within the previous 12 months)
3. fractures