cyrilzakka/clinical-trials huggingface dataset:
DD Obesity MRI Study

In this study, our novel MRI techniques for studying the small bowel will be applied to patients with diverticular disease. The ratio of visceral to subcutaneous fat will also be determined using MRI measurements. These data will be correlated with measurements of adipokines to determine if visceral fat has a specific influence on the severity of diverticular disease.

Colonic diverticulosis is the most common structural abnormality of the colon and studies suggest that its incidence and/or complications are increasing. Increasing evidence suggests a link between obesity and complications of diverticular disease. With the prevalence of obesity increasing in westernised populations, the risk of complications from diverticular disease is likely to also increase. At present however, there is little understanding of how diverticular complications are increased by obesity. A high BMI might be a surrogate marker for other lifestyle factors which predispose to diverticular complications. Visceral fat may also have an influence on related complications, due to the compounds secreted by adipocytes.

Altered bowel habit is a common complaint of diverticular patients. The cause is not well understood, is probably multi-factorial, and may include changes in the small bowel. Until recently, studies of the large and small bowel required intestinal intubation and perfusion and could not be performed on the undisturbed colon. New MRI techniques have now been developed, which allow these areas to be studied non-invasively. Abdominal fat can also be measured using MRI, and the distribution of subcutaneous and visceral fat will be compared for symptomatic and asymptomatic diverticular patients.

Eligibility Criteria:
Inclusion Criteria:

* Participants must have symptomatic and asymptomatic Diverticular disease confirmed on colonoscopy, barium enema or CT scan (Symptomatic disease is defined as lower abdominal pain \>1hr on 3 or more days per month for longer than 3 months.)

Exclusion Criteria:

* 1. Pregnant or lactating women. 2. Severe co-morbidity; e.g. heart failure, respiratory failure, alcoholism or drug dependence, 3. Inability to give informed consent. 4. If the participant has taken part in any other study on campus in the last 3 months they will not be able to take part in this study.

  5. Inability to lie supine 6. Inability to stop laxatives for 24hrs and antispasmodics or ondansetron for 8 hours prior to the commencement of the MRI study.

  7. Using long-term NSAIDs (non-steroidal anti-inflammatory agents e.g. ibuprofen), antibiotics or immunosuppressant drugs 8. Antibiotics within last 3 months 9. Other gastrointestinal inflammatory problems e.g. ulcerative colitis, Crohn's or Coeliac disease

MRI exclusions 10. Have a metallic implant 11. Have shrapnel inside the body 12. Ever had metallic fragments in the eye 13. Claustrophobia
Therapy of Chronic Cold Agglutinin Disease With Eculizumab

Evaluation of the efficacy and safety of eculizumab in symptomatic or transfusion-dependent patients with untreated or refractory hemolytic cold agglutinin disease(CAD)


Eligibility Criteria:
Inclusion Criteria:

* Individuals at least 18 years of age
* Diagnosis of CAD defined by the combination of chronic hemolysis, cold agglutinin titer (IgM or IgA) \>64 at 4°C, positive direct antiglobulin test (DAT) when performed with polyspecific antiserum, negative (or only weakly positive) anti-IgG, and strongly positive with anti-C3d
* LDH level \> 2 x upper limit of normal (ULN)
* Clinical symptoms requiring treatment, such as anemia, anemia-related symptoms or hemolysis-related symptoms
* Sufficient supplementation of iron, folic acid and vitamin B12 prior to treatment phase
* Patient must be willing and able to give written informed consent;
* Patients must be vaccinated against N. meningitidis at least 14 days prior treatment
* Patient must avoid conception during the trial using a method that is most appropriate for their physical state and culture

Exclusion Criteria:

* Active aggressive lymphoma requiring therapy or an active non-lymphatic malignant disease other than basal cell carcinoma or CIS of the cervix
* Liver disease with elevated LDH
* Absolute neutrophil count \< 500/µL
* Presence or suspicion of active bacterial or viral infection, in the opinion of the Investigator, at treatment start or severe recurrent bacterial infections
* Participation in any other investigational drug trial or exposure to other investigational agent, device, or procedure within 30 days prior to screening period
* Pregnant, breast-feeding, or intending to conceive during the course of the study, including the Post-treatment Phase
* History of bone marrow/stem cell transplantation
* Inability to cooperate or any condition that, in the opinion of the investigator, could increase the patient's risk by participating in the study or confound the outcome of the study
* Hypersensitivity to eculizumab, to murine proteins or to one of the excipients
Traumatic Ulnar Translocation of the Carpus

Ulnar translocation of the carpus is a form of wrist instability where the small bones of the wrist shift out of position. It is well recognized in patients with rheumatoid arthritis, but can also occur after a traumatic event, such as a violent football tackle or a fall from a height. The treatment options vary considerably, and there is no consensus of how to best address this injury pattern.

Because traumatic ulnar translocation is relatively rare, the diagnosis may be missed or delayed, causing problems for the patient such as persistent pain and loss of function. The investigators present 11 cases of this injury, discuss how to recognize it, and report our results after different treatment methods.

Ulnar translocation of the carpus is a form of wrist instability where the entire carpus translates medially along the inclined plane of the distal radius. This pattern of instability has been well recognized in patients with rheumatoid arthritis as a result of articular erosions and attenuation of wrist ligaments. In contrast, ulnar translocation of the carpus following trauma is seemingly rare, with published accounts limited to case reports and small case series.

The radiographic features of traumatic ulnocarpal translocation have been described and the instability pattern has been reproduced in cadaveric models. However, the recognition of radiocarpal malalignment may be unintentionally missed or delayed owing due to the uncommon nature of the this injury. The investigators present 11 cases of posttraumatic ulnar translocation of the carpus and review criteria for early recognition of the injury and the results following varying treatment methods.

Eligibility Criteria:
Inclusion Criteria:

Patient who suffered traumatic ulnar translocation of the carpus Willing to sign the consent

Exclusion Criteria:

Patients with collagen vascular disease
Gelsemium Sempervirens in Anticipatory Anxiety

To evaluate the effectiveness of Gelsemium sempervirens 5CH et 15CH on anticipatory provoked anxiety, in healthy volunteers.

State-anxiety can appear during banal events without objective harrowing factors. It is preponderant in particular situations as exams and competitive examination for example, and may be responsible of failures, notably at school. Particularly, a form of anxiety said anticipatory (largely named nerves) is focused on a coming performance. This anticipative anxiety, maximal before the beginning of the test, disappears during this test to let place to relief. Even if phenomenon of habituation exists, it can be responsible of social and professional failures.

Numerous therapeutics exists to fight against anxiety, non medicinal first but the resort to drugs are sometime necessary. The reference is the class of benzodiazepines. Many patients try non conventional medicines, like homeopathy.

Gelsemium sempervirens would be active on sensible et emotional persons, reducing anxiety in some situations. A large used of Gelsemium sempervirens is the case of a situation of provoked stress in particular exam. That is the reason why the drug is particularly intended to a population of young adults who don't want to use " traditional " tranquillizing. But this drug, largely used, has never showed his effectiveness on provoked anxiety, in biomedical research. That is why we proposed in this study to compare the effectiveness of Gelsemium sempervirens 5CH, Gelsemium sempervirens 15CH and placebo, in a situation of provoked anxiety in young adult healthy volunteers.

Eligibility Criteria:
Inclusion Criteria:

* Man or woman,
* age between 18 et 40 ans,
* affiliated to a regime of social security or equivalent

Exclusion Criteria:

* Medical history of psychiatric disease relevant of psychoses,
* Medical history of hospitalisation in psychiatric environment,
* psychotropic substance of the class of antidepressants, antipsychotics and normothymics), in the year before inclusion,
* Taking, even punctual of psychotropics substances of the class of benzodiazepines and related, in the month before inclusion,
* Taking, even punctual of psychotropics substances of the class of anxiolytics non benzodiazepines, in the month before inclusion: meprobamate, hydroxyzine, buspirone, captodiamine, pregabalin, etifoxine,
* Taking, even punctual of substances of the class of the sedatives divers, in the month before inclusion: phytotherapy, homeopathy, sedatives with brome, mineral elements,
* Taking, even punctual of substances of the class of antihistamine with hypnotic aim, in the month before inclusion,
* Taking, even punctual of propanolol in the month before inclusion
* Known Addiction,
* Handicap incompatible with the Stress Test : blindness, partially sighted, daltonism, dementia, language troubles,
* Pregnancy, parturient and nursing woman,
* Person private of freedom by judicial or administrative decision, person under measure of legal protection,
* allergy to one of the constituents
A Study of All-Cause and Cardiovascular Mortality in Type 2 Diabetes Patients Using Basal Insulin Detemir and Glargine

This study will examine the influence of the basal insulins detemir and glargine on risk of cardiovascular death and death from all causes in patients treated by their general practitioner in United Kingdom (UK). The data for this study will be drawn from the Clinical Practice Research Datalink (CPRD) Register.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis (ever) of type 2 diabetes
* Prescription (ever) of basal insulins glargine or detemir
* Insulin-naïve until initiation of basal insulins glargine or detemir
* Aged 40 years or older at start of observation period

Exclusion Criteria:

* Diagnosis of type 1 diabetes
Study to Evaluate Safety and Immunogenicity of Butantan Seasonal Influenza Vaccine - FLU-02-IB

Prospective cohort study to evaluate the safety and immunogenicity of the Butantan Influenza vaccine (Fragmented and Inactivated) among healthy adults with 18 to 59 years of age and elderly older than 60 years of age.

Prospective cohort study to assess safety of one dose of theButantan Influenza vaccine (Fragmented and Inactivated) in the first 3 days after vaccination and its immunogenicity 21 days after vaccination among healthy adults with 18 to 59 years of age and elderly older than 60 years of age..

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults, male or female aged 18 to 59
* Elderly aged 60 years completed and above
* To be available to participate in the study throughout its duration (approximately 21 days)
* To have medical indication to be vaccinated against influenza
* To demonstrate intention to participate in the study, as documented by signature in the study´s informed consent form.

Exclusion Criteria:

* Evidence of active neurological, cardiac, pulmonary, hepatic or renal disease as clinical history and/or physical examination (except hypertension under control among the elderly)
* Compromised immune system diseases including: HIV, diabetes mellitus, cancer (except basal cell carcinoma) and autoimmune diseases
* Behavioral, cognitive or psychiatric disease that in the opinion of the principal investigator or his representative physician, affects the participant ability to understand and cooperate with all study protocol requirements
* Abusive usage of alcohol or drugs in the past 12 months that has caused medical, professional or family problems, indicated by clinical history
* Known systemic hypersensitivity to eggs or to any component of the vaccine
* History of severe adverse reaction after previous administration of an Influenza vaccine within 6 weeks following vaccination
Anesthetic Management of Patients With Chronic Sleep Disorders

The aim of this study is to describe and compare the anaesthesia history and possible problems encountered in 3 groups of patients with 3 chronic sleep diseases: narcolepsy, idiopathic hypersomnia, and restless legs syndrome followed at the Montpellier Sleep Unit.

For each participant, existing data from the medical record will be used, with their consent. All participants will complete a standardized questionnaire, concerning their history of anaesthesia, the course and possible complications, and questions about their treatment for their sleep disorder.

This is both a retrospective and prospective single-center study. In the prospective part of the study, patients complete a self-questionnaire, with :

* a non-specific part, concerning the history of anaesthesia (locoregional or general), the patient's feelings about these anaesthesias (possible difficulties in waking up, pain) and details about the the course of the anaesthesia (including possible complications).
* a part specific to the sleep disease (possible rebound of symptoms, management of sleep treatments before and after anesthesia, sleep treatments before and after the different types of anesthesia).

Evaluation Criteria:

Main:

Frequency of history of locoregional and general anesthesia, and their possible complications.

Secondary:

Frequency of patients with rebound symptoms, or with worsening symptomatology (in each of the 3 groups, and in subgroups of patients with the same treatments), during locoregional and general anesthesia independently.

Other parameters collected via self-questionnaire (and at the time of the initial evaluation, retrospectively on medical records):

* Sociodemographic data: age, gender, body mass index
* Data related to the disease: age of onset of symptoms, age of diagnosis
* Other associated medical conditions
* Type of surgery
* Type, date and the number of anesthesia: locoregional, general

Eligibility Criteria:
Inclusion criteria:

* men and women, more than 16 years old
* diagnosed with a chronic sleep disorder including : Narcolepsy type 1, type 2, idiopathic hypersomnia, restless legs syndrome (diagnosis according to international criteria, ICSD-3, AASM, 2014).
* followed at Monpellier Sleep Disorders Unit.

Exclusion criteria:

- less than 16 years old at time of the study
A Study to Investigate the Interaction of BMS-986322 and a Combined Oral Hormonal Contraceptive (Ethinyl Estradiol [EE]/Norethindrone [NET]) in Healthy Female Participants

The purpose of this study is to evaluate the effect of multiple doses of BMS-986322 on the pharmacokinetics (PK) of Loestrin components in healthy female participants.


Eligibility Criteria:
Inclusion Criteria:

* Healthy participants, defined as having no clinically significant active or ongoing medical condition, physical examination abnormality, abnormal ECG finding, and abnormal clinical laboratory determinations that in the opinion of the investigator would compromise the conduct, results, or interpretation of the study findings.
* Have a negative QuantiFERON®-TB Gold test result at screening or documentation of a negative result within 4 weeks prior to the start of study intervention.
* Have a normal renal function at screening as evidenced by an estimated glomerular filtration rate (eGFR) ≥ 80 milliliter (mL)/minute (min)/1.732m\^2 calculated with the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula.

Exclusion Criteria:

* Any significant acute or chronic medical illness.
* Any acute infection or febrile illness within 7 days before Day 1 of Cycle 2.
* Any history or risk for tuberculosis (TB), specifically participants with 1) current clinical, radiographic or laboratory evidence of active TB; 2) history of active TB unless there is documentation that the prior anti-TB treatment was appropriate in duration and type; latent TB that has not been successfully treated.

Other protocol-defined inclusion/exclusion criteria apply.
Study of Safety, Efficacy and Pharmacokinetics of CT-707 in Patients With ALK-positive Non-small Cell Lung Cancer

This is a Phase I study of the ALK/FAK/Pyk2 inhibitor CT-707 in patients with ALK-positive non-small cell lung cancer.

The purpose of the study is to determine the MTD/RP2D of CT-707 and evaluate whether CT-707 is safe and has beneficial effects in ALK-positive advanced non-small cell lung cancer.


Eligibility Criteria:
Inclusion Criteria:

Patients must be diagnosed with ALK-positive advanced NSCLC. The tumor must be ALK-positive as determined by ALK rearrangement in ≥15% of cells (as measured by FISH using the Vysis break-apart ALK probe) or by using the Ventana ALK IHC test. The analysis may be performed locally.

Eastern cooperative oncology group (ECOG) performance status ≤ 2. Measurable disease as per RECIST v1.1

Availability of tumor sample:

Exclusion Criteria:

Patients with symptomatic central nervous system (CNS) metastases who are neurologically unstable or require increasing doses of steroids or local CNS-directed therapy to control their CNS disease Impaired cardiac function or any clinically significant cardiac disease Patients with abnormal laboratory values during screening and on day 1 of pre-dose Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of CT-707 Patient has a history of pancreatitis or history of increased amylase or lipase that was due to pancreatic disease.

Other protocol-defined inclusion/exclusion criteria may apply.
Study Evaluating Single Ascending Doses Of ILS-920

This is a first-in-human study of ILS-920. This study will provide an initial assessment of the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of ILS-920 after administration of ascending single intravenous (IV) doses to healthy adult subjects.


Eligibility Criteria:
Inclusion Criteria:

* Men or women of nonchildbearing potential
* Aged 18 to 50 years inclusive at screening.

Exclusion Criteria:

* Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
* History of drug abuse within 1 year before study day 1.
Time to Conceive: A Study of Fertility

The purpose of this research study is to learn a way to measure a person's fertility. After 1 year of trying, 1 out of every 7 women will not be pregnant. This is called infertility. This results in significant distress and anxiety. Infertility is common; however, the investigators have no markers to predict who will be infertile. For couples diagnosed with infertility, the investigators have used blood and urine hormone levels (follicle stimulating hormone (FSH), inhibin B, and antimullerian hormone (AMH)) to tell us who will get pregnant with fertility treatment. The investigators don't know if these hormone levels can predict if regular people trying to get pregnant will be able to get pregnant. This study will try to determine if these hormone levels can predict fertility and infertility.


Eligibility Criteria:
Inclusion Criteria:

* women between the ages of 30 and 44
* hoping to get pregnant and about to start trying or have been trying for less than 3 months
* living with male partner

Exclusion Criteria:

* currently using birth control with no intention of stopping
* have been trying to get pregnant for more than 3 months
* have used hormone shots for birth control in the past year
* have renal failure
* have known fertility problems, such as polycystic ovarian syndrome (PCOS)
* plan on moving outside of the Triangle Area in the next 6 months
Using MC1R Genotype to Impact Melanoma Risk Behavior

The purpose of this study is to examine how different messages about risk of melanoma can impact the way people protect themselves against developing these diseases.


Eligibility Criteria:
Inclusion Criteria:

CRITERIA FOR: NON-HISPANIC WHITE POPULATION

* Investigators will recruit participants from the Family Medicine and General Internal Medicine clinics of the Morsani Center at the University of South Florida.
* White, non-Hispanic patients who self-report a low phenotypic risk profile for development of melanoma and are able to read and speak English fluently.
* 18 years of age or older
* Capable of giving informed consent
* Potential participants will be screened for eligibility based on responses to questions about skin phenotypes, early detection behaviors and past history of melanoma.
* After signing informed consent, a biologic sample (saliva) will be collected for the purpose of DNA extraction determination of MC1R genotypes. All participants who carry high risk MC1R genotypes and a proportion of those who carry low risk or no MC1R variants will be randomized to the control or intervention arm.

CRITERIA FOR: HISPANIC POPULATION

* Investigators will recruit participants living in Tampa Bay and Puerto Rico as part of the U54 Ponce Health Sciences University-Moffitt Cancer Center (PHSU-MCC) Partnership. In Tampa Bay, participants will be recruited from the Family Medicine and General Internal Medicine clinics of the Morsani Center at the University of South Florida, and from the Suncoast Community Health Centers.
* Patients who self-report as Hispanics and are able to read and speak either Spanish or English fluently.
* 18 years of age or older
* Capable of giving informed consent
* Potential participants will be screened for eligibility based on responses to early detection behaviors and past history of melanoma.
* After signing informed consent, a biologic sample (saliva) will be collected for the purpose of DNA extraction determination of MC1R genotypes. All participants who carry high risk MC1R genotypes and a proportion of those who carry low risk or no MC1R variants will be randomized to the control or intervention arm.

Exclusion Criteria:

CRITERIA FOR: NON-HISPANIC WHITE POPULATION

* Have had a skin examination within the past year.
* Do not meet race/ethnicity criteria for their group
* White, non-Hispanic group - participants reporting sun-sensitive phenotypes
* A personal history of melanoma

CRITERIA FOR: HISPANIC POPULATION

* Have had a skin examination within the past year.
* Do not meet ethnicity criteria for their group
* White, non-Hispanic group - participants reporting sun-sensitive phenotypes
* Participants with a personal history of melanoma and/or more personal history of more than on squamous cell cancer (SCC) and/or Basal Cell Cancer (BCC)