cyrilzakka/clinical-trials huggingface dataset:
Critical Illness Neuromuscular Abnormalities in Neurocritical Care Patients

The aim of this research is to investigate critical illness neuromuscular abnormalities in neurocritical care patients.

Since 1984, the problem of critical illness neuromuscular abnormalities (CINMAs) has attracted considerable interest. According to these studies, CINMAs include the muscular weakness that accompanies critical illness resulting from polyneuropathy and/or myopathy and can be seen in 25-85% of cases of critically ill patients. Clinically, CINMAs present as symmetric flaccid tetraparesis and difficulty weaning off mechanical lung ventilation. However, these data are derived from treating non-specialized intensive care unit (ICU) patients. In this research, we wished to investigate CINMAs in neurocritical care patients. From day one of the patients' participation in the research and until a discharge from the ICU (or death), daily neurological surveys and weekly nerve conduction studies were performed. Based on the results of each nerve conduction study, an index of neuromuscular damage was noted to evaluate the severity of the CINMAs. Needle electromyography and muscle biopsy were not used

Eligibility Criteria:
Inclusion Criteria:

* Age: 16 years and older
* Acute primary cerebral pathology
* Mechanical ventilation
* Signs of systemic inflammatory response
* Exclusion of the possibility of an initial pathology of the spinal cord, peripheral nervous system and muscles in past medical history

Exclusion Criteria:

* Brain stem or bilateral hemispheric lesions with tetraparesis at the onset of illness
* Inability to perform high-grade nerve conduction studies
Effect of THAI Traditional Massage on Bone Markers

The purpose of this study is to explore the skeletal effect of Thai traditional massage by examining the changes in biochemical markers of bone turnover immediately after the massage.

Each subject received Thai traditional massage for 2 hours by a single masseuse.

Eligibility Criteria:
Inclusion Criteria:

* Healthy Thai women aged 20 to 40 years
* Have been massaged by Thai Traditional massage style

Exclusion Criteria:

* Hyperparathyroidism, Thyrotoxicosis, Diabetes Mellitus, Rheumatoid Arthritis, Cancer
* Antiresorptive agent, Teriparatide and Glucocorticoid
* Swelling Joints
Influence of Emotional Disorders and Executive on the Components Retrograde and Anterograde Episodic Memory in MS

Multiple sclerosis (MS) is an inflammatory disease of the central nervous system responsible for physical disability but can also cause cognitive disturbances annoying social and professional life of patients with the disease. Various studies have shown that there was a breach of episodic memory, working memory, attention and executive functions regardless of the form of disease, disability or duration of disease progression.

The main objective of this study is to investigate the influence of emotional components and executive processes on the components retrograde and anterograde episodic memory (thanks to an original paradigm based on the emotional valence of the memory) in MS patients


Eligibility Criteria:
Inclusion Criteria:

* Men and women 30-60 years of age
* Definite MS (McDonald criteria revised in 2005)
* EDSS \<6
* Sick Shapes: Relapsing multiple sclerosis, Primary progressive multiple sclerosis
* All durations evolution
* French Mother tongue
* Signature of informed consent

Exclusion Criteria:

* Other neurological conditions, previous psychiatric or developmental diagnosis of MS
* Head injury sequelae
* Chronic alcohol or drugs Taking
* EDSS greater than or equal to 6
* Secondary Progressive Form
* Push and / or treatment with corticosteroids within one month
* Treatments Amantadine, Modafinil introduced for less than 3 months
* Patient Trust
* Cognitive Assessment of less than one year (including in particular all or part of the balance sheet proposed in this project)
* Any visual motor deficit or incompatible with the award of cognitive tests
* For women, pregnancy, breastfeeding and / or lack of contraception (a pregnancy test will be done before the PET scan)
* Patient with indications against MRI
Safety, Tolerability, and Immunogenicity of Vaxelis™ in Children Previously Vaccinated With Vaxelis™ or Hexyon™ (V419-016)

The primary objectives of this study are to evaluate the safety, tolerability, and immunogenicity of a booster dose of Vaxelis™ (V419) given at \~11 to 13 months of age in healthy participants who were previously vaccinated with a 2-dose primary infant series of either Vaxelis™ or Hexyon™.


Eligibility Criteria:
Inclusion Criteria:

* Has received a 2-dose infant primary series of either Vaxelis™ or Hexyon™ at approximately 2 and 4 months of age

Exclusion Criteria:

* Has known or suspected impaired immunological function
* Has known or history of functional or anatomic asplenia.
* Has a known hypersensitivity to any component of the study vaccine.
* Has a known or suspected blood dyscrasia, leukemia, lymphoma of any type or other malignant neoplasm affecting the hematopoietic and lymphatic system
* Has a bleeding disorder contraindicating intramuscular vaccination
* Has a history of Hib, hepatitis B, diphtheria, tetanus, pertussis, or poliovirus infection
* Was born to a mother with a known history of hepatitis B infection
* Had a recent febrile illness (defined as rectal temperature ≥38.1°C \[≥100.5°F\] or axillary temperature ≥37.8°C \[≥100.0°F\]) occurring at or within 72 hours prior to receipt of study vaccine
* Has encephalopathy of unknown etiology, occurring within 7 days following prior vaccination with a pertussis containing vaccine
* Has an uncontrolled neurologic disorder or uncontrolled epilepsy.
* Has a health or developmental disorder that, based on the clinical judgment of the investigator, could affect evaluation of the vaccine
* Has received or is expected to receive an immunosuppressive agent
* Meets corticosteroid use criteria
* Has received any licensed, non-live vaccine within 14 days of study vaccine
* Has received any license live vaccine within 30 days of study vaccine
* Has received a blood transfusion or blood product within 6 months of study vaccine
Sexuality in Transmen During Hormone and Operative Treatment

With this analysis the investigators aim at discovering a difference in sexuality between transmen, cissexual women and cissexual men. A potential impact of body satisfaction will also be explored. Furthermore the investigators want to assess the gender dysphoria in transmen.

The aim of the study is to investigate transmen's sexuality and body satisfaction during hormonal and surgical reassignment. Furthermore sexual orientation, sexual behavior and gender dysphoria will be assessed.

Therefore an online survey with five measurements throughout the gender reassignment treatment is conducted. As a matter of Routine, postoperative complications will be recorded retrospectively. To compare transmen's data with cisgender women and men we will be using data of the questionnaire's validation studies.

The following questionnaires are used:

Sexuality: Multidimensionaler Fragebogen zur Sexualität (Brenk-Franz \& Strauß, 2011).

Sexual orientation: Fragebogen zur Sexualgeschichte und zum sexuellen Verhalten (Brenk, 2005) Gender dysphoria: Utrecht Gender Dysphoria Scale (Cohen-Kettenis \& Van Goozen, 1997) Body image: Fragebogen zum Körperbild (Clement \& Löwe, 1996) Sociodemographic questionnaire: age, education, work, living situation, relationship status, gender reassignment treatment so far, coming out Case report form

T0: baseline measurement (patient is at the start of the hormonal treatment or has already startet but has not undergone any gender reassignment surgery) T1: within 2 weeks before the mastectomy T2: 6 months (+/- 2 weeks) after mastectomy T3: 6 months (+/- 2 weeks) after colpectomy T4: 6 months (+/- 2 weeks) after the last gender reassignment surgery

Eligibility Criteria:
Inclusion Criteria:

* Transsexualism (Female to Male) approved by a psychologist's oder psychiatrist's report
* good German skills
* fully competent
* good computer skills

Exclusion Criteria:

* insufficient German
* patient rejects the participation
Biology Guided Therapy for Breast Cancer for ER Positive

There are several approved and guideline-recommended treatments for metastatic, estrogen receptor-positive breast cancer that has progressed on an aromatase inhibitor and a CDK4/6 inhibitor. Right now, doctors do not have a good way of choosing between these treatments. Scientists we work with have come up with ways to use the biology of the tumor to try to predict which treatment is best. This study is being done to test if those predictions are right and to learn more about these tumors to design better treatments in the future.

This is an open-label phase II study of systems biology guided therapy for breast cancer patients positive for Oestrogen receptor after Aromatase inhibitor and CDK inhibition.

Based on the SOLAR-1 trial, 25% of tumors would have PIK3CA mutation, so 25% of people would be treated with fulvestrant plus alpelisib with a median PFS in that group of 11 months and 75% of people would be treated with fulvestrant with a median PFS in that group of 6 months.(3) The weighted average of these medians is 7.25 months, but since the actual distributions of the progression free survivals are not available, we will use a conservative estimate of the expected median PFS of the historical control group (fulvestrant +/- alpelisib as second line unguided therapy) of 8 months.

Eligibility Criteria:
Inclusion Criteria:

* Histologic diagnosis of breast cancer
* Metastatic or incurable
* Prior treatment with an anastrozole or letrozole and a CDK4/6 inhibitor
* Progression while on or within 6 months of stopping the CDK4/6 inhibitor
* At least one lesion amenable to percutaneous biopsy that is not a purely sclerotic bone lesion
* ECOG 0-2
* Age 18 or greater
* Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.

Exclusion Criteria:

* Prior treatment within 2 years with fulvestrant, alpelisib, everolimus, or capecitabine
* Comorbid disease other than breast cancer with a life expectancy of less than 2 years
* Cancer other than breast cancer that is expected to need treatment within 2 years
* Platelets \< 100,000/microliter
* INR \> 1.5
Investigating the Impact of the Mental Health First-Aid Training Course in Danish Employees

The purpose of the study is evaluate the effect of the Mental Health First-aid training course on a Danish population of employees.

Background:

Studies show a high and growing prevalence of mental disorders in the population worldwide. 25 % of the general population in Europe will during their lifetime experience symptoms related to a mental disorder. The Mental Health First Aid concept (MHFA) was founded in 2000 in Australia by Kitchener and Jorm, in order to provide the population with mental health first aid skills.

Objective:

The aim of the concept is, through an educational intervention (course), to increase confidence in how to help people suffering from mental health problems. Further, secondary aims are to increase the mental health literacy of the public by increasing knowledge, reduce stigma and initiate more supportive actions leading towards professional help. An investigation of the effect of MHFA offered a Danish population is needed.

Design and Methods:

The design is a randomized controlled superiority trial, in which 500 participants will be allocated to either the intervention group or the control group. The control group will attend the course six months later, hence waiting list design. From fall 2013 to spring 2014 participants will be educated in Mental Health First-aid following a manualized, two days MHFA course. All the participants will answer a questionnaire at base-line and at 6 months follow-up. The questionnaire is a back-translation of the questionnaire used in Australian trials. The trial will be complemented by a qualitative study, in which focus groups will be carried out.

Outcome:

The primary outcome measure is increased confidence in help-giving behavior among the participants. Secondary outcome will be increased knowledge of and improved positive attitudes towards people suffering from a mental health problem.

Eligibility Criteria:
Inclusion Criteria:

people, who in their line of work are in contact with many different individuals

Exclusion Criteria:

none
UBT as a Diagnostic Tool for HP Prevalance

The prevalence of H. pylori infection in Pakistan is unknown and investigators want to assess it in dyspeptic patients utilizing UBT. At the same time investigators want to validate UBT sensitivity and specificity in Pakistani patients

The non-invasive methods for the diagnosis of Hp are the Urea Breath Test (UBT) and serological tests. The serological tests includes ELISA test in serum for Hp antibody and in stool for Hp antigen. Serum ELISA Hp antibody is not sensitive for showing active infection and the titres do not decrease even after successful eradication. Serology test cannot be used for those who have previously been treated for Hp, as the decline in titre of Hp antibodies is too slow to be of practical use. The stool Hp antigen detection test is more sensitive and specific as it detects bacterial antigens which will only be positive in the presence of Hp. However, it is cumbersome to collect stool and laboratory services are required. The C14 Urea Breath Test (UBT) is an office based test with sensitivity and specificity comparable to that of the stool antigen test. The diagnostic validity of these tests depends on the prevalence of H pylori infection. A higher prevalence would be associated with higher sensitivity and lower specificity. The safety profile of the urea breath test is very favourable, and no major side effects are associated with it. The aims of this study are to estimate H pylori prevalence in Pakistan among the adult dyspeptic population and to validate the sensitivity and specificity UBT in our population

Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects with dyspeptic symptoms (B1 Criteria of FD)
* Subject who has not been treated for H pylori eradication in the past
* Age above 18 years
* No Alarm symptoms of :

  * Gastrointestinal Bleeding
  * Anemia
  * Early satiety
  * Unexplained weight loss
  * Progressive dysphagia
  * Odynophagia
  * Recurrent vomiting
  * Family history of GI malignancy
  * Previous GI malignancy

Exclusion Criteria:

* Pregnant females
* Use of NSAIDs
* Use of anti- secretory agent (H2 blockers) and proton pump inhibitors in previous 4 weeks
* Use of anti- microbial agents (Clarithromycin, Metronidazole, Amoxacillin, quinalones) or bismuth in last 4 weeks
* .Gastric and/or duodenal erosions or ulcers, polyps or malignancy if noted on endoscopy will be excluded.
* Patients with predominant symptoms or gastro esophageal reflux disease (GERD) or Endoscopic evidence of esophagitis.
* Patients with abnormal upper abdominal ultrasound.
Anti-Tumor Activity Of SB-485232 In Patients With Previously Untreated Metastatic Melanoma

This Phase II study is designed to evaluate the anti-tumor activity of three dose groups of SB-485232 (0.01, 0.1, and 1.0 mg/kg/day) administered intravenously as a single agent in subjects with previously untreated metastatic melanoma.


Eligibility Criteria:
Inclusion criteria:

* Patients must have melanoma that has spread beyond the original location and has not yet been treated.
* Tissue from the spreading melanoma should have been tested to confirm it is melanoma.

Exclusion criteria:

* Patients having hepatitis or HIV infection.
* Taking corticosteroids.
* Patients with the primary site being occular melanoma or patients with melanoma of the brain.
COVID-19 Infection in Patients Infected With HIV and/or on PrEP

The SARS-CoV-2 epidemic was declared as a global pandemic by the WHO on March 12, 2020. France is affected with approximately 120,000 biologically confirmed cases, as of April 30, 2020, a figure probably very underestimated. Its distribution in different populations, in particular immunocompromised, has not yet been measured. The in vitro efficacy of lopinavir coupled with ritonavir, an HIV protease inhibitor, on SARS-CoV, responsible for SARS has been discussed and this therapeutic combination is currently being evaluated in patients infected with COVID-19. The possible protective role of treatment with Lopinavir / ritonavir or another HIV protease inhibitor has not been studied.

In addition, patients receiving HIV pre-exposure prophylaxis (PrEP) share certain epidemiological and behavioral characteristics with HIV-infected patients.

The objective was to carry out an epidemiological study aimed at determining the attack rate of COVID-19 infection in patients infected with HIV and or on PrEP and to analyze this attack rate according to the characteristics of these 2 populations and in particular the existence or not of an antiretroviral treatment comprising Lopinavir / Ritonavir or another inhibitor of the HIV protease.

Cross-referencing of Virology Laboratory data (positive or negative screening) and clinical-biological data can be easily carried out using a unique identification number in the 2 software programs and will allow an almost exhaustive epidemiological analysis in 2 well identified populations.


Eligibility Criteria:
Inclusion Criteria:

* HIV patients in Hospices Civils de Lyon
* on-PrEP patients in Hospices Civils de Lyon

Exclusion Criteria:

-
Astaxanthin (2 mg) + Lycopene (1.8 mg) + D-Alpha-Tocopherol (10 IU) For The Treatment Of Skin Aging

The purpose of this study is to determine the clinical efficacy of a combination of Astaxanthin (2 mg), Lycopene (1.8 mg), and d-alpha-Tocopherol (10 IU) in terms of its skin anti-aging properties. Specifically, the investigators aim to determine the increase in hydration levels of the skin, decrease in atypical skin pigmentation, and reduction of signs of photoaging, particularly facial fine lines.


Eligibility Criteria:
Inclusion Criteria:

* Healthy individuals age 30 to 60 years old
* Fitzpatrick Skin Type I-IV
* Crow's Feet Wrinkle Scale Class 1-2
* Subjects willing to provide written informed consent

Exclusion Criteria:

* Use of topical or oral anti-aging drug therapy 1 month prior to the study
* History of allergy to cosmetics and anti-aging drugs
* History of photosensitivity reactions
* Any current or past medical condition, including seizures and stroke
* History of pigmentation disorder such as but not limited to vitiligo and leukoderma
* Immunocompromised state
* Pregnant or lactating (pregnancy kit will be used to check)
* Patients who have undergone laser, radiofrequency, peeling, and other procedural therapies for anti-aging in the month prior to the study.
* Patients with current inflammatory or infectious skin disease on the face, or history of such in the month prior to the study.
* Patients taking OCDs and other photosensitizing drugs (e.g. tetracycline).
* Not willing to provide informed consent
Effect of ETI Performance on CPR Outcomes

This is a clinical observation study based on analysis of video-clip data of cardiopulmonary resuscitation (CPR) for out-of hospital cardiac arrest (OHCA) in emergency department. Aim of study is to evaluate effect of the factors relating endotracheal intubation (ETI) on the outcome of OHCA patients.

ETI is a standard method for placement of advanced airway during CPR. Frequent attempts or delayed ETI may affect adversely on the outcomes of OHCA. However, there was no known detailed data of explaining this issues.

This study tried to evaluate effect of factors of ETI including numbers of trial, time for ETI trial, interruption time and esophageal intubation during CPR on outcomes of OHCA patients.

Eligibility Criteria:
Inclusion Criteria:

* patients who suffered sudden cardiac arrest and intubated during CPR

Exclusion Criteria:

* case of requesting the do-not-atempt resuscitation
* patients who were diagnosed as adavanced cancer
* cardiac arrest by multiple trauma
Impact and Evaluation of the Management of Iron Deficiency With or Without Anemia in Patients With Cancer

In oncology, anemia is a frequent symptom, leading to complication of patient management for, more or less, a long term but often poorly evaluated by medical teams.

In oncology, anemia is induced by multiple causes. Iron deficiency appears to be a leading cause of anemia, especially in people with solid cancer. Iron deficiency is characterized by a low level of iron . Iron is a trace element required for life. It is a major component of hemoglobin allowing the transport of oxygen in red blood cells. There are in fact 2 types of iron deficiency: an absolute iron deficiency with a deficiency of true iron and a functional iron deficiency. Since end of January 2014, intravenous iron-based injections have been reclassified for cancer patients at ICO Paul Papin. The monitoring of iron deficiency with or without anemia is currently done in our institute, the ICO-Paul Papin. There is a procedure for the management of anemia with or without iron deficiency but there is still no traceability of treatments performed, their compliance or even their impact on the rate hemoglobin and the quality of life of patients during their treatment. This observatory also makes it possible to evaluate the impact of this treatment on the quality of life of the patients and thus allows them a personalized care of the tiredness during their treatment

The study is for patients with iron deficiency and / or anemia during treatment for cancer These patients will receive ferinject. Patients will perform functional assessments and complete quality of life questionnaires, when the ferinject will be injected, then at 1 month and 6 months.

Patients will be followed for 6 months in the study

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Patient with cancer regardless of the location
* Patient with specific treatment (chemotherapy +/- targeted therapy and / or radiotherapy, hormone therapy or surgery)
* Patient with Functional Iron Deficiency or absolute with or without anemia
* Having given written informed consent prior to any procedure related to the study.

Exclusion Criteria:

* Patient in a palliative situation not receiving specific treatment for their cancer
* Patient is willing and able to comply with the protocol for the duration of the study including all scheduled treatment, visits and examinations
* Patient with myeloproliferative disease
* Contraindication to treatments for iron deficiency and / or anemia
* Pregnant woman, parturient or nursing mothers
* Patient has no valid health insurance
* Disorder precluding understanding of trial information or informed consent
Assessment of Voriconazole Penetration Into the Brain by Fluorine-Magnetic Resonance Spectroscopy

The purpose of this study is to determine the amount of voriconazole in the brain by fluorine-magnetic resonance spectroscopy (MRS) and to compare brain levels to plasma levels.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteers 18-55 years of age

Exclusion Criteria:

* Subjects with any condition affecting drug absorption
* Subjects with a positive urine drug screen
Randomized, Controlled Study of CF Patients Between 3 Months and Less Than 7 Years

This study investigated the efficacy of inhaled TOBI treatment for early infections of P. aeruginosa in paediatric patients with cystic fibrosis.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of cystic fibrosis
* Early lower respiratory tract infection with P. aeruginosa,

Exclusion Criteria:

* Known local or systemic hypersensitivity to aminoglycosides or inhaled antibiotics.
* Administration of loop diuretics within 7 days prior to study drug administration.
* Other protocol-defined inclusion/exclusion criteria may apply