cyrilzakka/clinical-trials huggingface dataset:
Hand Disability in Systemic Sclerosis - Digital Ulcers

The aim of this study was to examine the Turkish validity and reliability of the Hand Disability in Systemic Sclerosis - Digital Ulcers Questionnaire (HDISS-DU) in individuals with Systemic Sclerosis.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with SSc by a rheumatologist
* Being 18 years of age or older

Exclusion Criteria:

* Presence of neurological disease
* Presence of any orthopedic problem that would affect functionality
* Presence of a history of orthopedic surgery
* Inability to speak or understand Turkish fluently
* Presence of a psychiatric disease that would affect cooperation
* Severe neurological disease that would affect hand functions (peripheral nerve lesion, trauma, operation, cerebrovascular accident)
* Heart failure and lung pathology that would affect daily living activities
Maraviroc Versus Etravirine In Combination With Antiretroviral Therapy In Drug Experienced HIV And Hepatitis Co-Infected Patients

Confirm the safety of maraviroc when used as a component of combination antiretroviral therapy in HIV and Hepatitis co-infected patients.


Eligibility Criteria:
Inclusion Criteria:

HIV-1 RNA viral load of ≥1000 copies/mL at the screening visit. Detectable HCV RNA levels or Hepatitis B surface antigen (HBsAg) positive. Previous antiretroviral treatment experience with at least 2 antiretroviral drug classes for ≥3 months.

Documented resistance to an NNRTI as well as documented resistance to another antiretroviral agent.

CCR5 tropic virus detected by the TrofileTM assay.

Exclusion Criteria:

Suspected or documented active, untreated HIV-1 related Opportunistic Infection (OI) or other condition requiring acute therapy at the time of randomization (subjects on a stable (\>1 month) secondary OI prophylaxis regimen are eligible for the study; subjects on a primary OI prophylaxis regimen of any duration are also eligible for the study).

Prior treatment with darunavir/ritonavir, raltegravir, or another integrase inhibitor, etravirine, maraviroc or another CCR5 inhibitor for more than 14 days at any time.

Subjects receiving treatment for chronic Hepatitis or the expected need to initiate HCV treatment within 48 weeks of randomization. (Subjects who were previously treated for Hepatitis C are eligible for the study).

AST and/or ALT greater than 5 times the upper limit of normal (ACTG Grade 3).
Safety, Tolerability and Pharmacokinetics of ALD1910 in Healthy Men and Woman

The purpose of this study is to determine the safety, tolerability and pharmacokinetics of ALD1910, a monoclonal antibody, administered by intravenous infusion and subcutaneous injection.

This is a first-in-humam, randomized, double-blind, placebo-controlled study in a healthy population. Up to 7 single ascending doses (cohorts 1 to 7) will be studied to determine the safety and tolerability of ALD1910. Approximately 96 healthy male and female participants are planned for the study, 64 for Part A and 32 for Part B.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy male or female
2. All female subjects must have a negative pregnancy test result and subjects to use of adequate contraception for the duration of the study.
3. Body Mass Index (BMI) between 18.0 and 30.0 kg/m2, and a total body weight of 50 to 100 kg inclusive.

Exclusion Criteria:

1. Use of prescription meds, nutritional supplements, OTC medications.
2. New or unusually strenuous exercise for the duration of the trial.
3. Current or previous drug or alcohol abuse.
4. Current, or previous smoker within 12 weeks prior to screening. Causal or social smokers are allowed.
5. Previous treatment or clinical trial with a monoclonal antibody 6 months prior to screening.
6. Current participation in any clinical research study.
7. ECG QTcF greater than or equal to 450 msec.
8. Greater than 6.4% glycosylated hemoglobin (HgbA1c) at screening
9. Fasting blood glucose greater than or equal to 126 mg/dL (7 mmol/L) at screening
Venticute in Patients With Pneumonia or Aspiration of Gastric Contents and Intubation/Ventilation/Oxygenation Impairment (BY2001/M1-007)

Study to demonstrate that administration of Venticute increases survival of patients with pneumonia or aspiration of gastric contents leading to intubation, mechanical ventilation, and severe oxygenation impairment.


Eligibility Criteria:
Main inclusion criteria:

* Patient has been intubated due to one of the following primary pulmonary insults: aspiration of gastric contents or pneumonia

Main exclusion criteria:

* Principal source of infection or sepsis is outside the lung
* Severe pre-existing lung disease
* Cancer metastatic to the lung or any end stage malignancy
* History of lung, liver, pancreas, small bowel, or bone marrow/stem cell transplantation
* Patient is morbidly obese
* Patient has a diagnosis of acute necrotizing pancreatitis

Additional criteria may apply and examination by an investigator is required to determine eligibility.
Performances on Cognitive Functions and Brain Function and Follow-up After Different Treatments in Patients With Autonomous Cortisol Secretion: a Single-center, Prospective, Observational Study

This is a single center, prospective, observational study to explore and evaluate the differences on cognitive function and brain function by functional-MRI in autonomous cortisol secretion patients, and the different treatments methods on the cognitive function and brain function in patients with autonomous cortisol secretion

Glucocorticoids, mainly cortisol, play a crucial role in the allostatic process of adjustment to stressors and can determine important changes in central nervous system structures. It is well known that Cushing's syndrome (CS) is associated with neurocognitive impairment in about two-thirds of cases. In CS the most frequent reported alterations are memory impairment (about 83% of cases) and reduced concentration (66% of cases) . Unfortunately, these alterations are only partially reversible after the hypercortisolism resolution. As so far, data related to the impact of autonomous cortisol secretion (ACS) on cognitive function are scarce and lack of magnetic resonance indicators. Few studies have studied the cognitive function changes of patients with ACS by surgical and conservative treatment. In the single center, prospective and observational study we aim to explore cognitive functions and brain function by functional-MRI in adrenal incidentaloma patients in relation to the presence of ACS and, secondly, in a group of acs patients, the effect of adrenalectomy on cognitive functions and brain function.

Eligibility Criteria:
Inclusion Criteria:

* age 20-65 years;
* ≥ 6 years of education；
* right-handed;
* complete entire cognitive function tests;
* adrenal lesions ≥ 1 cm in diameter;
* patients with non-functioning adrenal adenomas;
* patients with autonomous cortisol secretion.

Exclusion Criteria:

* \< 6 years of education;
* age \< 20 years or \> 65 years;
* maximum diameter of AI \<1cm;
* active malignancies;
* with a history of thyroid disease;
* with a history of acute infection in the last month;
* central nervous system diseases, including brain trauma, intracranial hemorrhage, acute cerebral infarction, etc;
* contraindications of MRI examination: such as implantation of metal prosthesis in vivo, claustrophobia, etc;
* adrenal tuberculosis;
* suspected or diagnosed adrenocortical carcinoma;
* unable to complete entire cognitive function tests;
* current use of steroids or any drugs known to alter steroid synthesis or metabolism in the previous 3 months;
* clinical Cushing syndrome;
* Cushing disease;
* primary hyperaldosteronism;
* pheochromocytoma;
* severe impairment of heart, liver, kidney and other organs;
* pregnant and lactating women
NGS in AML Relapse

Acute myeloid leukemia (AML) relapse is often associated with a clonal evolution at the cytogenetic and molecular level and therefore represents a challenge in the treatment of AML. Targeted sequencing is now usually done at diagnosis in AML, as only a small core group of genes is frequently mutated in AML and myelodysplastic syndromes. This approach, contrary to WGS is cheaper, together with a rapid turnaround and high sequencing coverage depths allowing the detection of variant allele fractions as low as 2%.

In the investigator's center, targeted analysis of AML patients is routinely realized at diagnosis and at relapse. In thses patients, five different clonal evolution patterns including cytogenetic and molecular analysis at relapse will be evaluated: (1) Stability, defined by no clonal change, (2) Gain, strictly defined by acquisition of additional variations (mutations or cytogenetic alterations), (3) Loss, strictly defined by loss of variants or regression, (4) Gain and Loss, indicating the combination of both Gain and Loss patterns, (5) Emergence, defined by the emergence of alterations that were unrelated to those found at diagnosis.

Karyotype and the mutations of up to 40 AML patients benefited from targeted NGS in the clinical hematology laboratory of the Hopitaux Universitaires de Strasbourg both at the time of the diagnosis of and the relapse will be studied, together with clinical and other biological characteristics.


Eligibility Criteria:
* Inclusion criteria:

  * patients with AML that relapsed studied in the clinical laboratory of hematology of the Hopitaux Universitaires de Strasbourg, France
  * given consentment or non-opposition for retrospective anonymous analysis of clinical and data
* Exclusion criteria:

  * person under tutorship-
  * persons who asked to withdraw from the study
An Interactive Web Platform to Teach Children Hunting, Shooting and Firearms Safety

Firearms injuries present a major pediatric public health challenge, killing \>800 children ages 0-15 annually and leading to lifelong disability among \>1000 survivors. About ⅓ of firearms injuries to children under age 15 are due to unintentional causes rather than suicide or homicide. The investigators propose development and evaluation of ShootSafe, an innovative, engaging, and educational website accessible by smartphone, tablet or computer that engages children to learn firearms safety.

ShootSafe extends existing programs to achieve 3 primary goals: a) teach children knowledge and skills they need to hunt, shoot, and use firearms safely; b) help children learn and hone critical cognitive skills of impulse control and hypothetical thinking needed to use firearms safely; and c) alter children's perceptions about their own vulnerability and susceptibility to firearms-related injuries, the severity of those injuries, and their perceived norms about peer behavior surrounding firearms use. ShootSafe will accomplish these goals through a combination of interactive games plus podcast videos delivered by peer actors (impactful testimonials about firearms injuries/deaths they experienced) and experts (wisdom \& experience from trusted role models). The website will also incorporate brief messaging to parents, who will absorb key lessons and reinforce them with their children.

The website will be evaluated through a randomized controlled trial with 162 children ages 10-12, randomly assigning children to engage in the ShootSafe website or an active control website on child nutrition. The investigators will incorporate sub-aims to evaluate changes in children's (a) knowledge, (b) cognitive skills in impulse control and hypothetical thinking, (c) perceptions about firearms safety, and (d) simulated behavior when handling, storing and transporting firearms. All outcome measures will be assessed at baseline, immediately post-intervention, and at a 4-month follow-up assessment to evaluate retention. Training will comprise two 30-minute sessions.


Eligibility Criteria:
Inclusion Criteria:

* children ages 10-12 years
* English-speaking child and parent
* Experience or exposure to firearms in their homes or through engagement in hunting or shooting

Exclusion Criteria:

* disabilities that prohibit participants from valid understanding of or participation in the experimental protocol
* siblings of enrolled child
Inari VISION Registry

This registry is a global prospective, non-randomized, multicenter, observational, active post-market data collection of Inari Medical devices and products.


Eligibility Criteria:
Inclusion Criteria:

1. Willing and able to provide informed consent per institution and geographical requirements
2. Has received treatment with an eligible Inari Medical device. NOTE: If patients are consented prior to their procedure and the procedure does not take place, the patient will be considered a screen failure.
3. Currently within enrollment window relative to their procedure
4. Age ≥ 18 years

Exclusion Criteria:

1. Is or will be inaccessible for registry follow-up
2. Meets exclusion criteria required by local requirements
3. Current or planned participation in another drug or device study that, in the investigator's opinion, would interfere with participation in this registry
4. Is pregnant or breastfeeding at the time of enrollment
Intestinal Dysmotility in Patients With Functional Digestive Symptoms

Automatic and non-invasive diagnostic methods based on the analysis of internal (intraluminal) and external (abdominal) images have been recently developed to measure intestinal motility. In patients with severe motor disorders, such as intestinal pseudo-obstruction, these new non-invasive techniques have shown to be equivalent to conventional intestinal manometry, the current gold-standard. However, these new techniques also detect less obvious signs of intestinal motor dysfunction, which are not detectable by conventional manometry.

High resolution manometry has been recently been applied to other parts of the digestive tract with great success, and probably will replace the actual gold-standard for intestinal motility evaluation. The investigators expect high-resolution manometry to be more sensitive than conventional manometry to the subtle motility disturbances detected by the new non-invasive techniques.

The purpose of this project is to demonstrate that intestinal motor function can be measured more sensitively and accurately using a combination of new technologies: high resolution manometry and the non-invasive diagnostic methods based on the analysis of images. The combined use of these techniques, following a step-wise algorithm, could allow to determine the mechanism, the affected regions and severity of the dysfunction in patients with intestinal dysmotility.


Eligibility Criteria:
Inclusion Criteria:

* Patients: digestive symptoms
* Healthy subjects: asymptomatic

Exclusion Criteria:

* Patients: organic disorders
* Healthy subjects: organic disorders
Hemodynamic and Respiratory Function in Healthy Pregnant Women

This study looks at hemodynamic and respiratory function in healthy pregnant women; it is a longitudinal study.


Eligibility Criteria:
Inclusion Criteria:

* Healthy pregnant women
The Effect of the Sexual Abstinence Period on the Production of Reactive Oxygen Species in Patients Who Planned to Take Part in Intrauterine Insemination

To determine the ideal sexual abstinence time for producing high quality sperm


Eligibility Criteria:
Inclusion Criteria:

* Patients who had made an application to Gazi University Obstetrics and Gynecology clinic for infertility and planned to have IUI (intrauterine insemination)

Exclusion Criteria:

* Erectile dysfunction- improper semen collection
Understanding Hemophilia A and B Drug Dosage Administration Patterns

Study Design

A prospective observational, cross-sectional epidemiological study in U.S. site-based clinical practice settings.

30 sites will enroll approximately 300 patients

Participating patients - or their caregiver in the case of patients under the age of 18 - will be consented to participate.

Physicians complete a retrospective chart review on each enrolled patient.

Patients will complete a one-time study questionnaire.

Study recruitment was stopped due to difficulty in enrolling the targeted number of patients on March 21, 2018. Subjects currently enrolled into the study have completed the study as per protocol. There were no safety concerns involved in the decision to stop enrollment.

Eligibility Criteria:
Physician/Clinician Participants:

* Must be a healthcare provider
* Currently manages at least 10 hemophilia A and/or B patients

Patient Participants:

* Willing and able to provide informed consent
* Diagnosed with hemophilia A or B
* Current disease severity is either moderately severe or severe with a clotting factor level of ≤5%
* If suffering from hemophilia A, must be currently taking moroctocog alfa (or another standard half-life treatment), rurioctocog alfa or efraloctocog alfa for at least six months.

(If currently taking rurioctocog alfa or efraloctocog alfa, must have been switched from a standard half-life treatment and had been on that prior treatment for at least six months).

* If suffering from hemophilia B, must be currently taking nonacog alfa or eftrenonacog alfa for at least six months (If currently taking eftrenonacog alfa, must have switched from nonacog alfa and had been on that prior treatment for at least six months).
* Infuse at least 3 times per month

Exclusion criteria:

* Female with hemophilia A or B
* Mild Haemophilia A or B
Hygiene and Bucco-dental Status of Patients With Oral Streptococcal Endocarditis

Infective endocarditis (IE) is a rare (30 cases / million / year in France) and serious disease (20 % of deaths during hospitalization and 40 % after 5 years). The development of an IE results from the meeting between a bacteremia and a pre-existent heart disorder, most of the time valvular, allowing the transplant of the circulating bacteria and their multiplication in the endocardium. Recommendations of prophylactic antibiotic treatment have been established since 1954 for some medical, particularly dental procedures, at the origin of bacteremia. But this policy has recently been questioned because its efficacy has not been demonstrated.

The purpose of this study is identify the situations with risk, by comparing the oral health status and the hygiene of patients having an IE with oral streptococci to those in patients having an IE with microorganisms not of oral origin.

It is a case-control observational study. The IE cases are recruited in hospitals participating to the french prospective observational "EI2008" cohort.

Cases are IE with oral streptococci whereas controls are IE with microorganisms not of oral origin.

Eligibility Criteria:
Inclusion Criteria:

* Major patient
* Definite IE caused by oral streptococci (case) or by non-oral pathogens (control)

Exclusion Criteria:

-
C11-Acetate PET/CT in Multiple Myeloma: Added Value to F18-Fluorodeoxyglucose PET/CT

Positron emission tomography combined with computed tomography using carbon-11 acetate (ACT PET/CT) may help detect lesions before treatment and evaluate response following therapy in patients with from multiple myeloma (MM). This study aimed to prospectively assess the clinical utility of ACT PET/CT in MM as compared to the commonly used F18-fluorodeoxyglucose(FDG).


Eligibility Criteria:
Inclusion Criteria:

* at least 20 years of age
* previously untreated
* complete pre-treatment clinical staging including bone marrow examination
* written informed consent to participate in the study

Exclusion Criteria:

* concurrent active malignant tumor(s)
* pregnant or breast feeding women
* non-compliant to PET/CT or to MRI
* marked renal impairment (contraindicated for contrast-enhanced MRI)
Understanding Oxytocin's Neural and Behavioral Effects in Adolescents Diagnosed With Autism

The investigators explored the neural and behavioral effect of oxytocin on youth with Autism spectrum disorder using magnetoencephalography (MEG). The investigators hypothesize that oxytocin will modulate neural activity to resemble patterns observed in the age-matched control group.

Thirty-two adolescents with autism and 26 typically developing adolescents participated in this randomized, double-blind MEG study. Individuals with autism arrived at the lab twice and received an acute dose of intranasal oxytocin or placebo in each session. During the scans, participants were asked to complete several tasks related to social perception - such as identification of social and non-social stimuli.

In the current study, the investigators aimed to explore oxytocin's influences on neural components that relate to social processing. Namely, we focused on M100, M170, and M250, which tend to show atypical patterns in individuals with autism.

The investigators also examined the effects of oxytocin on time dynamics - the change in specific oscillation over time and its effects on neural connectivity patterns.

Eligibility Criteria:
Inclusion Criteria:

* Males, aged 12-18 years
* Native Hebrew speakers
* Normal or corrected-to-normal vision
* Participants in the ASD group had to meet the criteria for ASD in the diagnostic and statistical manual of mental disorders (DSM-5)

Exclusion Criteria:

* Chronic medical problems
* Cardiovascular risk factors
* CNS disease
* Other mental illnesses
* Use of prohibited medications
* Mental retardation
* Impaired vision
* Impaired hearing
* History of significant head injury or neurological illness
* Current substance dependence diagnosis
* Metallic implants, braces or devices in the body
Acute Health Effects of Traffic-Related Air Pollution Exposure

This study aims to assess the effects of acute exposure to traffic-related air pollution and the underlying mechanisms.

The investigators will conduct a randomized, crossover trial among 72 healthy young adults in Shanghai, China. The eligible participants will be randomly divided into 2 groups (36 volunteers per group). During the first stage, participants will be requested to take one walking task (from 13:00 to 17:30). The exposed group will walk along a busy road and be exposed to traffic-related air pollution, while the control group will walk in a traffic-free park. During the first 3 hours, all participants will rest for 30 minutes after each 15-minute walking. From 16:00, participants will stop walking and rest for 1.5 hours. Then both groups will enter a 2-week washout period. In the second stage, there will also be one walking task (from 13:00 to 17:30). The two groups will exchange their walking sites and repeat the previous trial. Physical examinations will be performed both before and after each walking task. Besides, we will ask volunteers to stay in school during the two days before walking. Health examinations include symptoms questionnaires, blood pressure tests, Holter monitoring, and spirometry. We plan to collect blood, urine, oropharyngeal swabs, and exhaled breath condensate before exposure, about one hour after exposure, and next morning.

Eligibility Criteria:
Inclusion Criteria:

* Living in Shanghai during the study period;
* Body mass index \> 18.5 and ≤ 28;
* Non-smoking, no history of alcohol or drug abuse;
* Completing the walking task we required.

Exclusion Criteria:

* Current or ever smokers;
* Subjects with allergic disease, such as allergic rhinitis, allergic asthma, and atopy;
* Subjects with cardiovascular disease, such as congenital heart disease, pulmonary heart disease, and hypertension;
* Subjects with respiratory disease, such as asthma, chronic bronchitis, and chronic obstructive pulmonary disease;
* Subjects wih chronic disease, such as diabetes, chronic hepatitis, and kidney disease;
* Subjects with a history of major surgery;
* Abnormal spirometry (FEV1 and FVC ≤ 75% of predicted and FEV1/FVC ≤ 0.65);
* Medication use or dietary supplements intake in recent two months;