cyrilzakka/clinical-trials huggingface dataset:
Predictive Factors of Violence in Prison

Prison concentrates people with violent behavior and patients suffering from psychiatric disorders. Aggression are daily, the suicide rate is 5 to 10 times higher than the ordinary environment and current prevention devices have shown their limits.

That's why, in order to improve the violence's prevention in prison, the investigator propose to identify the predictive factors of violence by studying retrospectively the link between the psychiatric profile and commission of violence after being jailed.

From the 1st January to the 31 December 2012, every man incarcerated was screened thanks to the Mini International Neuropsychiatric Interview (MINI) to establish the presence of a current and/or past psychiatric diagnoses. In addition, collection of violent incidents based on penitentiary's reports (aggression, suicide, self-mutilation, intoxication, murder...) was conducted .

Then statistic analysis compared psychiatric characteristics of prisoners according to whether they commit violence or not within 12 months after being jailed, distinguish the authors of self and hetero aggressive violence. Those tests are completed with a cluster analysis to precise psychiatric from criminological profiles of dangerousness.

Eligibility Criteria:
Inclusion criteria:

- being jailed from 1st january 2012 to 31 dec 2012 in the Villeneuve Lès Maguelonne prison (Hérault, France)

Exclusion criteria:

- opposition form, unable to understand french, age under 18
Nasal and Pulmonary Nitric Oxide Output in COVID-19 Infection

A Study of the relation of COVID-19 infection and its severity to upper and lower airway nitric oxide, upper airway viral load and lung function.

Materials and methods: Prospective cohort of 40 COVID-19, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), positive patients from Tampere university hospital region are recruited to the study. Forty COVID-19 negative patients with similar symptoms act as a control group.

All subjects are screened for other respiratory viruses with reverse transcriptase polymerase chain reaction (RT-PCR)-multiplex tests. Viral loads of SARS-CoV-2 from anterior nasal cavity, nasopharynx, throat and saliva are evaluated by RT-PCR cycle treshold (Ct) value and antigen testing (RLU value).

During the first visit NEWS (National Early Warning Score), recorded pulmonary auscultation (Thinklabs One, Thinklabs Medical LLC), impulse oscillometry (Tremoflo, THORASYS Thoracic Medical Systems Inc), FeNO (fractional exhaled nitric oxide) and FnNO (fractional nasal nitric oxide) (NIOX VERO®,Circassia) are conducted. All aforementioned and a spirometry are measured again after 2 months.

Aims: To evaluate the relation of COVID-19 infection and its severity to upper and lower airway nitric oxide, viral load and lung function. To compare the capability of RT-PCR in detecting SARS-CoV-2 RNA from saliva, anterior nasal swab samples and oropharyngeal swap samples vs. the golden standard of nasopharyngeal swab samples. To compare the results of RT-PCR and antigen test in detecting SARS-CoV-2 from nasal and pharyngeal sample sites.

Eligibility Criteria:
Inclusion Criteria:

* capable of breathing through nose, no need of supplemental oxygen, symptom onset within 10 days, positive SARS-CoV-2 test in Fimlab and capable of performing all required tests

Exclusion Criteria:

* need of supplemental oxygen, pregnancy, lactation, incapability of performing the tests for any reason, use of organic nitrate medication
Tamoxifen to Reduce Unscheduled Bleeding in New Users of the Levonorgestrel-releasing Intrauterine System (LNG-IUS)

This study evaluates the ability of tamoxifen to improve frequent or prolonged bleeding in new users of the 52mg levonorgestrel-releasing intrauterine device (IUD). Half of participants will receive a course of tamoxifen three weeks after insertion of the IUD, while the other half of participants will receive a course of placebo.

New users of the LNG IUD will be eligible. Subjects will be randomized to receive tamoxifen 10 mg twice daily for 7 days or placebo. Study drug will be started 3 weeks after placement of the IUD. Subjects will maintain a record of daily bleeding and spotting using an electronic text messaging diary.

Eligibility Criteria:
Inclusion Criteria:

* initiating use of 52mg levonorgestrel-releasing IUD for contraceptive purposes
* access to reliable cell phone
* willing to receive and respond to daily text or email message to assess bleeding

Exclusion Criteria:

* using IUD for indication other than contraception
* postpartum within 6 months, pregnant, or breastfeeding
* removal and replacement of IUD
* undiagnosed abnormal uterine bleeding prior to placement of IUD
* bleeding dyscrasia
* anti-coagulation use
* active cervicitis
* allergy to tamoxifen
* history of venous thromboembolism
* personal history of breast or uterine malignancy
* use of medication contraindicated with use of tamoxifen (coumadin, letrozole, bromocriptine, rifampicin, aminoglutethimide, phenobarbital)
Dose Escalation Study of ZG006 in Participants With Advanced Small Cell Lung Cancer or Neuroendocrine Carcinoma, Followed by Dose Expansion Study in Participants With Advanced Small Cell Lung Cancer

This is a multicenter, open-label phase I/II study, divided into 2 parts:

Part 1 involves a dose-escalation study of ZG006 in which the safety and tolerability of ZG006 in patients with advanced small cell lung cancer or neuroendocrine carcinoma are explored. Upon completion of Part 1, investigators and the sponsor will discuss and determine two recommended phase II doses (RP2D) based on safety, preliminary efficacy, and pharmacokinetic (PK) results for use in Part 2.

Part 2 is a phase II dose-expansion study of ZG006, aiming to investigate the efficacy and safety of ZG006 in patients with advanced small cell lung cancer.


Eligibility Criteria:
Inclusion Criteria:

* Fully understand the study and voluntarily sign the informed consent form;
* Male or female 18\~75 years of age;
* Eastern Cooperative Oncology Group(ECOG) Performance Status of 0 or 1;
* Life expectancy ≥ 3 months;

Exclusion Criteria:

* Participants were deemed unsuitable for participating in the study by the investigator for any reason.
The Clinical Feature of Ulcer Base Over Time After Prophylactic Argon Plasma Coagulation in Colonic EMR

The prophylactic APC right after colonic EMR doesn't mean the complete coagulation of visible vessel because of injection material.

The aim of this study was to evaluate the clinical feature of the visible vessels in ulcer base over time after prophylactic APC in colonic EMR.

The prophylactic Argon plasma coagulation (APC) of non-bleeding visible vessels seems not to have an additional advantage in the prevention of delayed post polypectomy bleeding in recently studies. However, immediate APC after endoscopic mucosal resection (EMR) may not mean the complete coagulation of exposed vessels because of injection material. The aim of this study was to evaluate the clinical feature of the exposed vessels in ulcer base over time after prophylactic APC in colonic EMR. Methods: This study was designed as a prospective study. Investigators excluded diminutive polyp, large polyp (\> 2cm), long stalk pedunculated polyp, and clear ulcer base after EMR. Between August 2013 and May 2014, patients who were enrolled underwent prophylactic APC for non-bleeding visible vessels after colonic endoscopic mucosal resection. After checking the complete coagulation of visible vessels, the numbers of visible vessel group were counted by lap of time such as 1, 3, 5, and 7 min in ulcer base.

Eligibility Criteria:
Inclusion Criteria:

* Underwent prophylactic APC for non-bleeding visible vessels after colonic endoscopic mucosal resection.

Exclusion Criteria:

* Diminutive polyp, large polyp (\> 2cm), long stalk pedunculated polyp, and clear ulcer base after EMR.
Virtual Peer-to-Peer (VP2P) Support Mentoring for Adolescents With Cancer

The overall aim of this research program is to develop and examine the impact of a Cancer virtual peer-to-peer (VP2P) Support Program on health-related quality of life (HRQL) in adolescents with cancer (AWC). In the current proposal, the feasibility of trialing the Skype-based VP2P program providing peer-support from mentors and the magnitude of program effect estimates will be evaluated in a pilot randomized control trial (RCT). This pilot RCT will enable us to refine the program and determine the appropriate sample size for a future large-scale RCT, which will compare the effectiveness of VP2P to a waitlist control group at a major Children's Oncology Group- affiliated centers in Canada and the United States.

The aim of this project is to develop and examine the impact of a virtual peer support program on health outcomes and quality of life of adolescents with cancer using a waitlist randomized controlled trial. In addition to standard medical care, adolescents in the experimental group will receive a manualized peer mentorship program that will provide modelling and reinforcement by trained young adults aged 18-25 years who have learned to function successfully with their pain. Mentoring sessions consist of 10 sessions of 30-45 minute Skype calls over 8 weeks. Feasibility of the program will be measured in addition to quality of life, physical and emotional symptoms, pain coping, self-efficacy, social support, and self-management skills.

Eligibility Criteria:
Inclusion Criteria:

* English-speaking 12-17 year olds
* Cancer diagnosis with an expected 5-year survival rate of \>70% according to treating oncologist (most childhood cancer diagnoses meet this criterion1)
* Access to computer capable of using free Skype software (NB: 87% of American households had Internet access in)
* Karnofsky or Lansky performance status of 60/100 (minimal assistance needed to complete activities) as assessed by the study coordinator at the time of recruitment. The Principal Investigator and Co-Investigators (Dr. Jennifer Stinson, Dr. Nathan and Dr. Gupta) will train the study coordinator to complete Karnofsky or Lansky performance assessments.
* NB. Note that even though text messaging is part of the intervention, access to smartphones is not required. Smartphones (iPhone 6) may be loaned to participants by Dr. Stinson.

Exclusion Criteria:

* Significant cognitive impairment or major co-morbid illness as identified by their treating oncologist
* Participation in other peer support or self-management programs
* Receiving end-of-life care
The Effect of Laughter Yoga on Nurses Psychological Resilience and Sleep Quality During the Pandemic Period

This study aimed to determine the effects of laughter yoga on the psychological resilience and sleep quality of active nurses during the pandemic period. Initial stage of labor on randomized controlled birth outcomes and maternal satisfaction. A total of 100 nurses, determined by power analysis, were recruited into the randomized controlled, single-blind clinical study. The study included 2 groups (group A nurses who had active contact with patients diagnosed with or at risk of covid-19, group B: nurses who had active contact with patients diagnosed or at risk of covid-19 and participated in laughter yoga practice. Laughter yoga; immune system It has been proven by experimental studies that there is a connection between antibodies and endorphins, that it has a healing effect, that it accelerates the circulatory system as an adverse effect to stress, and that it has a vasodilation effect in the vessels.

The study data were collected by the researchers using online systems with the snowball method due to the pandemic. The inclusion criteria of the study (not having undergone abdominal surgery in the last three months, not having uncontrolled hypertension, not having glaucoma, hernia, epilepsy, not having received a psychiatric diagnosis-treatment, not having received a diagnosis-treatment for sleep problems, having done laughter yoga before) The study consisted of 100 nurses who agreed to participate in the study. Descriptive features form consisting of 13 questions, Connor-Davidson Resilience Scale (CD-RISC) scale and Pittsburgh Sleep Quality Index (PSQI) were used to collect data. Research data were collected in 3 months. During the study, 4 people from the experimental group (3 people did not attend the sessions regularly, 1 person left voluntarily), 6 people from the control group (he left voluntarily) quit the study. Finally, the research was completed with 90 nurses, 46 of which were in the experimental group and 44 in the control group.

Eligibility Criteria:
Inclusion Criteria:

* Not have undergone abdominal surgery in the past three months
* Not have uncontrolled hypertension
* Not have epilepsy
* Not have received a psychiatric diagnosis or treatment
* Working actively during the pandemic period

Exclusion Criteria:

* Not attending sessions regularly
Study of ACTR T Cell Product in Combination With Trastuzumab in Subjects With HER2-Positive Advanced Solid Tumor Cancers

This is a Phase 1, open-label, multi-center study to assess safety and determine the recommended phase 2 dose (RP2D) of ACTR T cell product (ACTR707 or ACTR087) in combination with trastuzumab, following lymphodepleting chemotherapy in subjects with HER2-positive advanced malignancies.


Eligibility Criteria:
Inclusion Criteria:

* Signed written informed consent obtained prior to study procedures
* Histologically-confirmed Her2 positive advanced solid tumor malignancy with documented disease progression during or immediately following the immediate prior therapy, or within 6 months of completing adjuvant therapy for subjects with breast cancer
* Subjects must have previously received adequate standard therapy for treatment of their malignancy

  * For those with metastatic breast cancer, must have received HER2-directed therapy including trastuzumab, pertuzumab and ado-trastuzumab in any breast cancer disease setting
  * For those with advanced gastric cancer, adequate prior treatment with HER2-directed chemotherapy is required
* At least 1 measurable lesion by iRECIST
* Able to provide fresh tumor biopsy or archived block specimen taken since time of most recent anti-HER2 mAb-directed therapy
* ECOG of 0 or 1
* Life expectancy ≥ 6 months
* LVEF ≥ 50% by MUGA or ECHO
* Absolute neutrophil (ANC) count ≥ 1500/ µL
* Platelet count ≥ 100,000/µL
* Hemoglobin ≥ 9g/dL
* Estimated GFR \>30mL/min/1.73m2

Exclusion Criteria:

* glioblastoma multiforme or other primary CNS tumors are excluded
* clinically significant cardiac disease
* clinically significant active infection
* clinical history, prior diagnosis, or overt evidence of autoimmune disease
* current use of more than 5mg/day of prednisone (or an equivalent glucocorticoid)
* Prior treatment as follows:

  * prior cumulative doxorubicin dose greater than or equal to 300 mg/m\^2 or equivalent
  * chemotherapy within 2 weeks of enrollment
  * external beam radiation within 2 weeks of enrollment (28 days if CNS-directed therapy)
  * any monoclonal antibody (mAb) or other protein therapeutic containing Fc-domains within 4 weeks of enrollment
  * pertuzumab within 4 months of enrollment
  * Experimental agents within 3 half-lives or 28 days prior to enrollment, whichever is shorter
  * allogeneic hematopoietic stem cell transplant (HSCT)
  * prior infusion of a genetically modified therapy
* Pregnant or breastfeeding
Nasal Muco-ciliary Clearance Study With and Without Salt Inhalation

Investigating nasal muco-ciliary clearance by scintigraphy

The velocity and the retention of the nasal muco-ciliary clearance is going to be investigated with a salt particle inhaler and a placebo by the method nasal scintigraphy.

The hypotheses is that nasal inhalation of salt particles enhance the nasal mucociliary clearance.

Eligibility Criteria:
Inclusion Criteria:

* COPD patients (all severities in chronic, stable condition)
* Asthma patients (in stable condition without acute asthma symptoms)
* Healthy subjects, incl. smokers (no chronic nasal, upper or lower respiratory diseases)

Exclusion Criteria:

* Age under 18 years
* Upper respiratory tract infection / cold within the last 3 weeks and at least 3 weeks must pass from the person has become well to the examination
* Allergic / non-allergic rhinitis (hay fever)
* Chronic sinusitis
* Acute respiratory tract infection in antibiotic therapy
* Applied salt inhalation within the past month
* Pregnant or breastfeeding women
* Nuclear medical examination within the past month
* Cannot taste saccharin
Multi-session Anodal Cerebellar Transcranial Direct Current Stimulation (tDCS) vs Anodal Cerebral tDCS

To investigate which one of the two cerebellar and cerebral stimulation in comparison to sham stimulation is more effective in enhancing balance and postural stability in stroke patients


Eligibility Criteria:
Inclusion Criteria:

* The study focused on individuals who had their first stroke,
* Additionally, participants needed to have a score of 6 or higher on the Johns Hopkins Fall Risk Assessment Tool (JHFRAT).
* The inclusion criteria mandated that participants must have the ability to give written consent, walk without any help, and
* have a functional condition that allows them to actively participate in the Biodex balancing training program.

Exclusion Criteria:

* Individuals with concurrent neurological problems such as Alzheimer's, Parkinson's, or cerebellar abnormalities,
* as well as those with psychological ailments, were excluded during the initial assessment phase.
* In addition, individuals who scored below 20 on the Mini Mental Status Examination Test (MMSE),
* displayed motor disorders that affected their ability to walk or use their lower limbs,
* were currently taking sedative medications, had amnesia, depression, radiculopathy, lumbar spinal cord root involvement, auditory or visual impairments, vertigo, recent fractures, severe cardiac problems,
* or had undergone electrotherapy that affected their nervous system within the past two weeks were also not included in the study.
St. Jude Medical Product Longevity and Performance (SCORE) Registry

SCORE is an active, prospective, non-randomized, multi-center outcome-oriented registry of patients implanted with St Jude Medical (SJM) market-released cardiac rhythm management (CRM) products. This registry will be conducted in the United States (US).

The primary purpose of the registry is to evaluate and publish acute and long-term performance of market-released SJM CRM products by analyzing product survival probabilities. Product status and any related adverse events will be collected to measure survival probabilities.


Eligibility Criteria:
Enrollment Criteria:

* Patient has a standard indication for a CRM implantable device.
* Patient is implanted with at least one new market-released SJM CRM product from a list provided by SJM (e.g pacemaker, ICD, CRT-D, CRT-P, pacing/sensing lead, defibrillation lead) within the last 90 days.
* Complete system implant information (e.g. model, serial number, location) is available at enrollment.
* Any product-related adverse event information at implant is available at enrollment.
* Patient or appropriate legal guardian is willing to provide authorization for registry participation.
Non-invasive Quantification of Atrial Fibrosis by MRI in Atrial Fibrillation

Three groups of patients will be considered: a control group (n = 10); a group of patients with paroxysmal or persistent AF with AF cryoablation procedure - within this group, MRI will replace CT-scan usually performed in routine before the procedure (n = 15); a group of patients with permanent AF (n = 15). MRI study will include pulmonary veins angiography with gadolinium injection (0.20 mmol/kg), 2D-cine imaging and late-enhancement imaging. A 3D gradient-echo sequence(Flash 3-D) will then be applied 20 minutes after the injection, with the following parameters : echo time 0.98 ms, repetition time 2.53 ms, angle 15°, resolution 2.0x1.3x1.0 mm. T1 map and two T2 sequences will be performed so as to determine LA relaxation times. Argus software will be used for post-treatment imaging. Quantitative data will be expressed in mean ± SD. A comparison of T1 and T2 values in LA will be performed between the three groups. Statistics will be performed with SPSS software in bilateral analysis and a value of p \< 0.05 will be considered as significant.


Eligibility Criteria:
Inclusion Criteria:

All persons \> 18 years, which have:

gp paroxysmal or persistant FA

1. paroxysmal or persistent FA (under one year),
2. refractory to at least one antiarrhythmic drug therapy
3. eligible for an ablation procedure with cryotherapy
4. the patient may benefit from surveillance. gp permanent FA permanent AF ( defined as chronic arrhythmia after 2 failed attempts to electrical cardioversion and / or more than one year old) , and hospitalized for cardiac reasons or not in different cardiology Timone .

Exclusion Criteria:

* age \< 18 years,
* cons -indications to MRI ( claustrophobia, pacemakers and implantable cardiac defibrillators , metal chips intra ocular , valvular mechanical prosthesis ) , allergy to gadolinium ,
* renal impairment ( creatinine clearance \<60 mL / min)
* pregnant or nursing ( a pregnancy test must be performed for women of childbearing age at the time of inclusion , the result of this test will be communicated to them .
* the MRI examination takes place three months after the inclusion women of childbearing potential should be placed under effective contraception)
An Observational Study of Avastin in First Line in Elderly Patients With Metastatic Colorectal Cancer (CASSIOPEE)

This multicenter, prospective, observational study will evaluate the efficacy and safety of Avastin (bevacizumab) in first-line therapy in elderly patients with metastatic colorectal cancer. Data will be collected from eligible patients for24 months.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/= 75 years of age
* Metastatic colorectal cancer
* Initiating Avastin first-line therapy in combination with chemotherapy

Exclusion Criteria:

* Previous Avastin therapy
* Patient participating in a clinical study evaluating a cytotoxic anti-cancer therapy and/or an investigational new drug
Comparison of Two Abdominal Exercise Programs on the Interrect Distance

The objective of the research is to compare two programs of exercises in postpartum woman, one based in abdominal strengthening exercises and the other based in abdominal hypopresive exercise.

Diastasis recti abdominisis the separation of the two rectus abdominis muscles along the linea alba with a consequent separation of fibres and widening of the same. The linea alba has different functions which include supporting the proximal anterior recti, guaranteeing the stability of the vertebral column, pelvis and the pelvic floor, and intervening in the function of the abdominal muscles since it serves as their anterior anchorage.

The crunch abdominal exercise (classic abdominal) is the most studied exercise used to test the behaviour of the linea alba, and in most cases, a decrease in the inter-rectus distance is observed when compared to the resting stage. In the oder hand, Abdominal hypopresives exercises were designed for women in the postpartum period but the effects over the abdominal muscles is unknown and the authors are unaware of any study that evaluates the effect of a hypopressive exercise program on the interrectus distance.

The objective of the research is to compare two programs of exercises in postpartum woman, one based in abdominal strengthening exercises and the other based in abdominal hypopresive exercise.

Eligibility Criteria:
Inclusion Criteria:

* Women having given birth 8 weeks before starting the study treatment
* Women agree to participate in the study
* Women with vaginal delivery.

Exclusion Criteria:

* Women with abdominal hernia
* Pregnancy woman
* Previus Abdominal Surgery