cyrilzakka/clinical-trials huggingface dataset:
A Safety, Tolerability, and Efficacy Study of VC-01™ Combination Product in Subjects With Type I Diabetes Mellitus

The purpose of this trial is to test if VC-01™ combination product can be implanted subcutaneously in subjects with Type 1 Diabetes and maintained safely for two years. It will also test if VC-01 is an effective treatment for subjects with Type 1 Diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Men and women (non-pregnant and non-childbearing potential)
* Diagnosis of type 1 diabetes mellitus for at least 3 years
* Stable diabetic treatment
* Willingness to use a continuous glucose meter
* Acceptable candidate for implantation

Exclusion Criteria:

* Advanced complications associated with diabetes
* Immunosuppressive therapy
COVID-19 IN CHILDREN IN NIGER, 2020

On January 30, 2020, the WHO declared COVID-19 a global health emergency. Children were affected with less severe forms. Niger had implemented measures in a context where children are a source of contamination. The objective was to determine the factors associated with COVID-19 in children in Niger from February to August 2020 through an analysis of the national database.

We conducted an analytical cross-sectional study including all COVID-19 suspects in the database. We used Excel and Epi Info 7.2.4. software for data extraction and analysis. Frequencies and proportions were calculated, we estimated in a logistic regression the OR of association with their 95% confidence interval, the factors associated with COVID-19 at the threshold of p\<0.05.

Results: Of 572 notified suspected COVID-19 cases in children aged 0-15 years, 11.36% were positive. The median age of infected children was 10 years \[IQR: 5- 13 years\]. The sex ratio of males to females was 2.1. Children aged 11-15 years were 49.2%, 61.5% resided in Niamey, 4.6% had comorbidities. The notion of travel was 12.3% and 40% had a notion of contact, 24.4% had a fever, 23.2% had a cough, 18% were hospitalized and the case fatality was 1.5%. In etiological analysis, the factors associated with COVID-19 were sex ORa= 0.51 \[0.28-0.93\] p=0.028, the presence of symptoms ORa= 2.29 \[1.23-4.25\] p=0.008 and the notion of contact ORa= 0.32 \[0.13-0.77\] p=0.011.

exposed children were sensitive to COVID-19, all age groups were affected with a male predominance. We recommend barrier measures adapted to young people, early detection and management of infected children.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 0-15 years suspected of having COVID-19 whose data were in the DSRE database were included

Exclusion Criteria:

* Children whose data is not complete
Systematic Psychological and Medical Care for Children With SCD

Sickle cell disease (SCD), a genetically transmitted blood disease, necessitates life-long care. In children, the disease may cause intense pain and other severe complications. Studies show that sources of stress, as well as complex psychological and intercultural issues associated with SCD, often aggravate symptoms. At Louis Mourier hospital, the treatment model used is systematic psychological and medical care. Our hypothesis is that this care is beneficial for both the children and their families as seen in improved quality of life and positive impact on medical symptoms.

In this observational multicentric pilot study, our goal is to assess the effectiveness of a systematic medical-psychological approach in place for the past 6 years at the Louis Mourier Hospital, as compared to the usual practice in 2 other pediatric hospitals for SCD which focus essentially on the medical issues associated with SCD. Two psychologists will interview 80 children and their primary care-takers at Louis Mourier hospital, and 80 children and their care-takers of the other two centers, using a standard comprehensive care for SCD. For the parents, we propose to use a semi-structured interview including a prepared interview guide, the Loneliness Questionnaire, and the parents' version of KIDSCREEN (10 items). For the children, according to their age, The Rey-Osterrieth Complex Figure Test (ROCF), the Draw a Person in the Rain Test (DPR), the KIDSCREEN questionnaire, and semi-directed interview will be used. Relevant information from the patients' medical record directly related to the symptomatic expression of the SCD will be noted on a data collection form. This phase is scheduled to last 12 months. A statistical and qualitative analysis of the results will be carried out at the end of the study.

Eligibility Criteria:
Inclusion Criteria:

* children with sickle cell disease
* treated in one of the three investigational centers
* All major forms of the disease will be studied regardless of the country of origin.

Exclusion Criteria:

* Refusal of the parents or the child to participate.
* Child or parent living in France for less than 6 months
Swiss studY for the Treatment of COPD Patients With the Free combiNation of indacatERol and GlYcopyrroniumbromide.

The study purpose is to evaluate the effect of QAB149

* NVA237 vs. QAB149 on static lung hyperinflation.

This is a multicenter, randomized, double-blinded, single-dose, cross-over, placebo-controlled study. The primary endpoint was chosen to demonstrate the superiority of a single-dose of the combined inhalation vs. the mono inhalation regarding the Inspiratory Capacity (IC) peak value. A total of 78 patients will be randomized to complete two visits with two single doses of treatment. Patients will be randomized in a cross-over manner. Treatment visits will be separated by a study medication wash-out period.Treatments will be administered in a blinded fashion.

The patients will be male and female patients, ≥40 years of age, with a documented diagnosis of moderate or severe COPD according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria and \>10-pack years history of smoking, FEV1 \<80% and ≥30% of the predicted normal value.

Eligibility Criteria:
Inclusion criteria:

* Male and female patients, ≥40 years of age, with a documented diagnosis of moderate or severe COPD according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria and \>10-pack year history of smoking
* FEV1 \<80% and ≥30% of the predicted normal value who have signed an informed consent form prior to the initiation of any study-related procedure

Exclusion criteria:

* No COPD exacerbations within 6 weeks prior to dosing
* No concomitant lung disease such as asthma
* Nno requirement for long term oxygen treatment or history of lung reduction surgery
* No medical conditions that would interfere with the performance of spirometry
* No other medical condition that in the opinion of the investigator may cause the patient to be unsuitable for completion of the study or place the patient at potential risk form being in the study e.g. uncontrolled hypertension or unstable ischemic heart disease.
Study of Concurrent Chemoradiotherapy for Locally Advanced Esophageal Squamous Cell Carcinoma

The phase I study is to determine the maximum tolerated dose and dose limiting toxicity of docetaxel and nedaplatin prescribed twice weekly in combination with concurrent chest radiotherapy in patients with locally advanced esophageal squamous cell carcinoma.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed esophageal squamous cell carcinoma
* Inoperable stage II-III (AJCC/UICC; seventh edition), confirmed by contrast- enhanced computed tomography,endoscopic ultrasonography, barium esophagram, emission computed tomography and/or positron emission tomography/computed tomography.
* Eastern Cooperative Oncology Group (ECOG) performance status 1-2
* Estimated life expectancy of at least 12 weeks
* Charlson comorbidity index≤4
* Adequate bone marrow function: white blood cells grade 0 or 1,absolute neutrophils grade 0 or 1, platelets grade 0, haemoglobin grade 0 or 1
* Adequate renal function: creatinine grade 0 or 1
* Adequate liver function: serum bilirubin grade 0 or 1, alanine aminotransferase and aspartate aminotransferase \<2 times of the upper normal limit
* Weight loss≤15% during 6 months prior to diagnosis
* Forced expiratory volume second≥1L

Exclusion Criteria:

* Prior history of malignancy, except for nonmelanoma skin carcinoma or cervical carcinoma in situ
* Previous anti-tumor therapy, including surgery, chemotherapy or radiotherapy
* Contraindication for chemotherapy or radiotherapy
* Malignant pleural or pericardial effusion
* Women in pregnancy or lactation period
* Women who has the probability of pregnancy without contraception
* Weight loss≥15% during 3 months prior to diagnosis
* In other clinical trials within 30 days
* Addicted in drugs or alcohol, AIDS patients
* Uncontrollable seizure or psychotic patients without self-control ability
* Severe allergy or idiosyncrasy
* Not suitable for this study judged by researchers
AccuLIF® PROSPECTIVE PATIENT OUTCOMES STUDY

This is a post-market clinical study of the AccuLIF expandable transforaminal lumbar interbody fusion (TLIF) cage in patients requiring surgery for degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis, at one or two levels, between L2 and S1.

Study evaluations will be evaluated pre-operatively and at 6-weeks, 3-months, 6-months, 12-months and 24-months post-operatively to assess clinical outcomes, patient reported outcomes and radiographic status.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is skeletally mature and between 18 and 70 years of age.
2. DDD and up to Grade I spondylolisthesis or retrolisthesis, requiring decompression and arthrodesis at one or two contiguous levels between L2 and S1.
3. No previous surgery at the same or adjacent level (other than microdiscectomy / laminectomy) at the same or adjacent level.
4. Non-responsive to conservative (non-surgical) treatment for back pain for a minimum of 6 months.
5. Subject understands the conditions of enrollment and is willing to sign and date the Informed Consent.
6. Subject agrees to comply with visit schedule and completing study questionnaires.

Exclusion Criteria:

1. Significant instability of the spine.
2. Requires TLIF at more than 2 levels between L2 and S1.
3. Previously undergone lumbar spine surgery (other than microdiscectomy / laminectomy) at the same or adjacent level.
4. Younger than 18 years of age, or older than 70 years of age.
5. BMI of 40 or greater.
6. History of metabolic bone disease
7. Osteoporosis
8. Diabetes mellitus requiring daily insulin management.
9. Subject has any of the following:

   1. Progressive neuromuscular disease; OR
   2. Autoimmune disease; OR
   3. Active malignancy within the last 15 years; OR
   4. Active hepatitis; OR
   5. AIDS, ARC, or is HIV positive; OR
   6. Syringomyelia at any spinal level; OR
   7. Any other condition that would interfere with the subject self -assessment of pain, function or quality of life.
10. Allergy to implant materials (titanium, titanium alloy).
11. Active systemic infection or infection localized to the site of implantation.
12. Primary or metastatic tumors involving the spine.
13. Open wounds or inadequate issue tissue coverage over the operative site.
14. History of significant mental illness or mental incapacity.
15. Pregnancy or intent to become pregnant.
16. Participating in another investigational study for a similar purpose.
17. Belongs to a vulnerable population that would compromise ability to provide informed consent or compliance with follow-up requirements.
18. Smokers unwilling to cease up to 3 months post-op or recent history of alcohol or other substance abuse within the past 2 years.
19. Workers compensation.
Cognitive Training in Parkinson's Disease

The purpose of this research study is to determine whether cognitive training will improve cognitive and brain functions in people with Parkinson's Disease (PD) during activities of daily living using cognitive evaluations and magnetic resonance imaging (MRI).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of idiopathic PD
* Age ≥ 40 years
* Expected to be on a stable dopaminergic medication regimen throughout the study period

Exclusion Criteria:

* Non-English speaking
* Pregnancy
* Breastfeeding
* Excessive alcohol consumption (\> 7 drinks per week for women, \> 14 drinks per week for men) or illicit substance use
* History of a neurological disorder such as a brain tumor, stroke, central nervous system infection, multiple sclerosis, movement disorder (other than PD), or seizures
* History of schizophrenia, bipolar disorder, attention deficit disorder, or obsessive-compulsive disorder
* History of head injury with loss of consciousness longer than a few minutes
* Metallic surgical implants or traumatically implanted metallic foreign bodies
* Inability to lie flat for about an hour in the MRI scanner
* Discomfort being in small, enclosed spaces
* Dementia at screening (Montreal Cognitive Assessment score \< 21/30)
* Cognitive problems in activities of daily living suggestive of more than mild cognitive impairment (PD Cognitive Functional Rating Scale \> 4)
* Mild cognitive impairment according to the Movement Disorders Society (MDS) Level II comprehensive assessment criteria (\> 1.5 standard deviations below the norm in two tests in a single cognitive domain or in one test in two separate cognitive domains, with the exception that the executive domain scores can be up to 2 standard deviations below the norm)
* Hoehn \& Yahr stage \> 3 (i.e., able to stand and walk, but not fully independent)
* Focal neurological findings on exam that suggest cerebral pathology other than that associated with parkinsonism
* Motor symptoms that could potentially introduce too much motion artifact in the imaging data (e.g., MDS-Unified PD Rating Scale resting tremor score \> 2 in limbs, head/chin tremor, or more than mild dyskinesia by history or exam)
Effect of 3 Years of Exercise in Patients With Atrial Fibrillation

This is a substudy of "Generation 100". The investigators will follow the persons with atrial fibrillation to see if 3 years of interval or moderate exercise affects the burden of atrial fibrillation, symptoms, use of health services or echocardiographic findings.


Eligibility Criteria:
Inclusion Criteria:

* Included in the "Generation 100 study"
* Atrial fibrillation diagnosis verified by ECG

Exclusion Criteria:

-
Prophylactic Antibiotic After Perineal Tear

Current World Health Organization guidelines recommend routine antibiotic prophylaxis for women with perineal tear 3rd and 4th degree but not for 2nd degree because of insufficient evidence of effectiveness. The investigators aimed to investigate whether antibiotic prophylaxis prevented maternal infection after the first and second perineal tear after vaginal birth.

The PATPET trial is a randomized, controlled trial done at tertiary hospital obstetric units in Israel. Women who had first and second-degree tear (or after episiotomy) after delivery at 37 weeks or greater gestation, with no indication for ongoing prescription of antibiotics in the post-partum period and no contraindications to prophylactic Cefamezin (cefazolin), were randomly assigned (1:1) to receive a single intravenous dose of prophylactic antibiotic or not.

Eligibility Criteria:
Inclusion Criteria:

* age 18-45
* perineal tear 2nd and 1st degree( episiotomy)

Exclusion Criteria:

* 3rd and 4 th degree perineal tear
* antibiotic indication during delivery
* cesarian section delivery
Efficacy and Safety of Erector Spinal Plane Block (ESPB) for Analgesia in Laparoscopic Cholecystectomy

Purpose: to evaluate the efficacy and safety of erector spinal block (ESB) for analgesia in laparoscopic cholecystectomy（LC）.

Method: This study is a randomized, single-blind, controlled clinical trial. Pre-operative ultrasound-guided bilateral erector spinae plane block will be performed in the ESPB group. Vertebral side block will be performed in the VSB group. And the control group will receive local anaesthesia after the surgery. Intraoperative and postoperative analgesia effect and side effects will be compared between the three groups.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status 1-3
* Scheduled for elective laparoscopic cholecystectomy surgery under general anesthesia

Exclusion Criteria:

* patient refusal
* pregnancy
* history of allergy to study drugs
* neurological and cognitive disorders
* coagulopathy
* chronic pain disorders
* infections at the injection site
* history of abdominal surgery
Social Media Impact on Patients' Regarding Aesthetic Dental Treatments

The aim of this observational study was to describe dental patients the use of social media related to aesthetic dental treatments. The main questions it aims to answer were:

* Describe the use of social media before undergoing an aesthetic treatment.
* To assess the influence of social media prior to undergoing aesthetic treatment

Participants answered a web-base questionnaire.

In recent years, an increased use of social media has been observed. Therefore, the aim of this observational study is to describe the use of social media in dental patients in relation to aesthetic dental treatments, as well as, its possible influence. A 25-question questionnaire was designed with the following 4 sections: (i) informed consent; (ii) demographic characteristics; (iii) cosmetic dental treatments; and (iv) social media use.

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years old that use social media

Exclusion Criteria:

* Not having undergone any aesthetic dental treatment
The Effect of Reiki on Pain, Stress and Comfort Level in Students Experiencing Dysmenorrhea

The aim of this study is to determine the effect of reiki on pain, stress and comfort level in students experiencing dysmenorrhea

Hypotheses 01; there was no difference between the pain score of the reiki group and the pain score of the control group.

H02; there was no difference between the stress score of the reiki group and the stress score of the control group.

H03;there was no difference between the comfort level of the reiki group and the comfort level of the control group.

The study will be carried out in two different groups. The practice will start with meeting the students who experienced dysmenorrhea. After the women are evaluated in terms of eligibility criteria for the research, the women who are eligible will be informed about the research and written informed consent will be obtained from the women who accept. The random distribution of women to the study groups will be carried out using the Block Randomization method. The following applications will be made to the groups.

Reiki Group The intervention will be applied to the reiki group to be applied in the midwifery department application laboratory. Reiki therapy will be applied by a practitioner with a Reiki application certificate in the application laboratory for 30 minutes while the participants lie down with their eyes closed. 4 sessions of reiki application will be applied to the intervention group for a month. Reiki application will start from the time of menstruation, the first pain scores and comfort conditions will be recorded. Menstruation and general comfort after 4 sessions will be recorded. Any medication and side effects during menstruation with the last reiki application will be recorded by the research team member.

Placebo Reiki will be applied to the participants in the group in the application laboratory of the midwifery department of the faculty of health sciences. The practice will be carried out in the application laboratory for 30 minutes, with the participants sitting with their eyes closed. Reiki life energy will not be transferred to participants in the placebo reiki group. Since the participants' eyes are closed, they will not know that there is a transfer. Placebo Reiki application will be performed in the laboratory 4 times during a month. Placebo application will start from the time of menstruation, and the first pain scores and comfort conditions will be recorded. After 4 sessions, menstruation and general comfort will be recorded. Any medication and side effects during menstruation with the last application will be recorded by the research team member.

Eligibility Criteria:
Inclusion Criteria:

* Agreeing to participate in the research and volunteering,
* over 18 years of age,
* without a diagnosed psychiatric disease,
* without communication problems,

Exclusion Criteria:

-
Using Video Laryngoscopy for Neonatal Intubation

This study examines the effectiveness of utilizing video laryngoscopy to give real-time guidance during neonatal intubations to improve residents' success at performing intubations.

To evaluate whether residents who receive guidance from a supervisor concurrently viewing the neonate's airway via video laryngoscopy will have a higher rate of successful neonatal intubations than residents receiving guidance using traditional direct laryngoscopy.

The investigators conducted a randomized controlled trial involving 48 first and second year pediatric and medicine-pediatric residents who received either video-facilitated (VDL) or traditional (TDL) supervisor guidance during direct laryngoscopy. Residents attempted intubations in the neonatal intensive care unit according to their randomization group. The primary outcome was a successful intubation that occurred within two attempts.

Eligibility Criteria:
Inclusion Criteria:

* 1st and 2nd Year Pediatric and Medicine-Pediatric Residents at the University of Rochester

Exclusion Criteria:

* Residents who declined participation
Core Cerebrospinal Fluid Biomarker Profile in Anti-Leucine Rich Glioma Inactivated 1 (Anti-LGI1) Encephalitis

Limbic encephalitis associated with anti leucine-rich glioma inactivated-1 LGI1 antibody (anti-LGI1) usually presents with seizures and progressive disturbance of memory and behavior. But anti-LGI1 associated encephalitis (LGI1-E) could present with a variety of features including an elective cognitive form of the disease, which mimicks a neurodegenerative condition such as Creutzfeld Jakob disease or rapidly progressive Alzheimer disease. In these patients, the appropriate diagnosis could be challenging.

The primary aim of this study is to describe cerebrospinal fluid biomarkers in a cohort of LGI1-E patients as results of these markers are currently not described in LGI1-E. Moreover, patients with LGI1-E often present seizures. At this point, the impact on cerebrospinal fluid biomarkers has not been described in this condition. The secondary aims of this study are to compare cerebrospinal fluid (CSF) biomarkers in LGI1-E patients to these in other neurodegenerative conditions ( e.g. creutzfeld Jakob disease, Alzheimer disease), which are considered as a possible differential diagnosis in these patients. The last aim of this study is to look for correlations between cerebrospinal fluid biomarkers in LGI1-E and clinical data in these patients, especially seizure.


Eligibility Criteria:
Inclusion Criteria:

* Presence of well characterized leucine rich glioma inactivated 1 (LGI1) antibody in serum or cerebrospinal fluid (CSF);
* LGI1 antibody associated encephalitis diagnosis according to the international guidelines;
* At least one core CSF biomarkers sample (T-tau, P-tau, AB-1-42) available after disease onset;
* Age at least 18 years old.

Exclusion Criteria:

* Absence of clinical data