cyrilzakka/clinical-trials huggingface dataset:
Contraceptive Practices and Cervical Screening in Women With Cystic Fibrosis

Little is known about gynaecological follow-up and cervical screening in Cystic Fibrosis (CF). Only few studies have described contraceptive practices in cohorts of CF women.

The investigators did a cross-sectional study in a cohort of 155 CF women attending the Lyon adult centre. Women attending the CF adult centre in 2014 completed a written questionnaire about their contraceptive choices, frequency of gynaecological follow-up and cervical screening. Other clinical data were collected from the CF adult centre registry.

One hundred and twenty women (100%) answered the questionnaire, among whom two were post-menopausal (46 and 59 years of age), and five were pregnant.

Seventy-four per cent of the women declared they had undergone gynaecological followup (89% of the women with transplantation), and only 55% reported having at least one previous Pap smear test. Among the transplanted patients, only 58% had had a Papsmear test, despite immunosuppressive treatment. The overall rate of contraception was only 64% and in diabetic women, it was 61%. Among contraception users; 65% used oral contraception, predominantly combined estrogen-progestagen (47%); among diabetic patients, 26% used progestin-only contraception. Intrauterine device accounted for 10% of patients using contraception, and tubal ligation only 4%.

This study is limited by its cross-sectional design. Despite an internal validation of the questionnaire showing an almost perfect agreement, the risk of recall bias has to be taken into account.

This study of practices highlights the importance of improved information regarding sexuality, fertility and reproductive health in young women with CF. A regular gynaecological follow-up and cervical screening is mandatory in this population.

Better gynaecological care and contraceptive advice would help to avoid unplanned pregnancies, and optimize contraceptive selection in relationship to specific clinical conditions.


Eligibility Criteria:
Inclusion Criteria:

* woman with cystic fibrosis
* followed in the Lyon adult centre in 2014

Exclusion Criteria:

- No exclusion criteria
Long Term Evaluation of Tubal Expansion on Obstructive Dysfunctions of Eustachian Tube

The study aim is to evaluate the tubal score on patients who suffer from obstructive dysfunction of eustachian tube before and after the eustachian tube dilatation.

The study aim is to evaluate the tubal score on patients who suffer from obstructive dysfunction of eustachian tube before the intervention and 12 months after the eustachian tube dilatation.

This patients are refractory to the reference medical treatment.

Eligibility Criteria:
Inclusion Criteria:

* patients between 20 and 80 years old
* tubal score lower than 5
* patients who already used reference medical treatment

Exclusion Criteria:

* patients who already do a major surgery of middle ear
* tympanic perforation
* pregnant or breastfeeding woman.
* patients who can't be follow during 14 months
The Underlying Mechanisms Regarding the Effect of Glucagon on the Kidneys Will be Investigated in Healthy Males.

The goal of this crossover study is to investigate to what extend glucagon affects the kidneys. The main questions it aims to answer are:

Does glucagon regulate kidney function through extraction in the kidney in addition to glomerular filtration? Does glucagon regulate kidney function by increasing renal plasma flow and glomerular filtration rate? Does glucagon regulate kidney function by increasing renal salt excretion?

In patients with type 2 diabetes mellitus, plasma concentrations of glucagon are inappropriately high (hyperglucagonemia). Hyperglucagonemia has been speculated to contribute to the pathophysiology of diabetic kidney disease. Previously, glucagon has been assumed to cause glomerular hyperfiltration associated with urinary excretion of small proteins, a characteristic of early type 2 diabetic kidney injury. Further, glucagon has been shown to acutely increase urinary excretion of urea, sodium, and potassium, and patients with end-stage renal disease have elevated plasma levels of glucagon.

The purpose of this study is to clarify the underlying mechanisms behind the physiological effects of glucagon on kidney function and the kidney's ability to clear glucagon from the blood in healthy males. Specifically, the investigators aim to answer the following questions:

Does glucagon regulate kidney function through extraction in the kidney in addition to glomerular filtration? Does glucagon regulate kidney function by increasing renal plasma flow and glomerular filtration rate? Does glucagon regulate kidney function by increasing renal salt excretion?

The renal extraction of glucagon and the renal effects of glucagon will be investigated during a constant glucagon infusion in 10 healthy men aged 20-60 years. The study will be placebo-controlled. Each subject will participate in three independent and randomized trial days with a washout period of at least four weeks.

Eligibility Criteria:
Inclusion Criteria:

* Age: 20-60 years
* Normal health ascertained through questioning and medical examination
* Normal values for blood concentrations of fasting plasma glucose, fasting plasma total cholesterol, fasting triglycerides, HDL, LDL, creatinine, liver function, and electrolytes
* Informed consent

Exclusion Criteria:

* Immunosuppressive treatment in the preceding 12 months
* Alcohol abuse
* Medical treatment with oral glucocorticoids, dipeptidyl peptidase-4 (DPP-4) inhibitors, or GLP-1 receptor agonists, which, in the opinion of the investigator, may interfere with glucose metabolism
* Use of lithium
* Medical treatment that affects insulin secretion or cardiovascular performance measures
* Liver disease (ALT \> 2x normal value)
* Renal impairment (se-creatinine \> 130 μM and/or albuminuria)
Clinical Trial of Group ACYW135 Meningococcal Polysaccharide Vaccine 002

The clinical trial was designed to evaluate the safety and immunogenicity against Group ACYW135 Meningococcal Polysaccharide Vaccine of Hualan administered on subjects 2 years of age and older.

Complying with requirements of the approval letter of clinical trial issued by SFDA (Approval Letter No.: 2006L01017), Hualan conducted phase II clinical trial of Group ACYW135 Meningococcal Polysaccharide Vaccine to evaluate the safety and immunogenicity of the experimental vaccine.

The safety end points were the presence of any systemic, local and adverse reaction. Evaluation indicators of immunogenicity were bacteriocin levels of groups A, C, Y and W135 respectively in the serum after the whole vaccination.

Eligibility Criteria:
Inclusion Criteria:

* Healthy permanent residence 2 years of age and older, the subjects (or their guardians) are able to understand and sign the informed consent;
* Healthy male or female by oral history, physical examination and clinical judgment and who complies with vaccination of this product;
* Be able to comply with the requirements of clinical trial protocol and immunogenicity examination;
* Have no history of vaccination within the past 3 months and vaccination with other products within the last 2 weeks;
* Axillary temperature ≤37.0℃.

Exclusion Criteria:

* Any acute disease, such as: tumor, autoimmunity disease, progressive atherosclerotic disease or diabetes with complication, chronic obstructive pulmonary disease need oxygen uptake, acute or progressive hepatopathy or nephropathy, congestive heart-failure, etc.;
* Allergic to vaccines or drugs (history of allergy to any vaccine in the past);
* History of neurologic symptom or signs;
* Known or suspected (or high risk) impaired or abnormal immune function, e.g.: receive immunosuppressant or immunopotentiator therapy, take immunoglobulin or blood product or plasma extract (except the gastrointestinal tract) within the past 3 months, HIV infection or related disease, etc.;
* History of meningitis infection or vaccination of meningococcal vaccine within the past 3 months;
* History of receiving other vaccines or immunoglobulin injection or any research drugs;
* Any acute disease needing application of antibiotics or anti-virus treatment in the whole body within the past 1 week;
* History of fever within the past 3 days (axillary temperature ≥38.0℃);
* Participating in another clinical trial;
* History of allergy, eclampsia, epilepsy, encephalopathy and mental disease or family disease;
* Thrombopenia or other coagulopathy that may cause contraindication to intramuscular injection;
* Acute chronic disease (such as Down syndrome, diabetes, sickle cell anemia or neurologic disease, Guillain-Barre Syndrome);
* Known or suspected diseases, including: respiratory system disease, acute infection or active stage of chronic disease, SBAV infection of children or mothers, cardiovascular disease, acute hypertension, cancer treatment, skin disease, etc.;
* Pregnancy
* Any condition that, in the judgment of investigator, may affect trial assessment.
Assessment of Serum CD25 Level in Systemic Sclerosis Patients with or Without Interstitial Lung Disease (ILD)

Assessment of serum level of sCD25 in SSc (with or without ILD) and its correlation with disease activity.

Evaluating the clinical correlation of serum soluble CD25 (sCD25) in systemic sclerosis (SSc) (with or without ILD).

Interstitial lung disease (ILD) comprises of a large group of idiopathic diffuse processes that affect the lung parenchyma. Connective tissue disease-associated lung disease (CTD-ILD) represents one of the most common causes of ILD. Along with idiopathic pulmonary fibrosis (IPF), they both represent the majority of ILDs. Since CTD-ILD typically follows a better clinical course compared to IPF, and hence therapies differ substantially between them, an accurate diagnosis is critical. Up to 30% of newly diagnosed ILD will be due to CTD. This underscores the importance of investigating all patients with ILD for possible underlying CTD.

Systemic sclerosis (SSc) is a systemic autoimmune disease in which inflammation and fibrosis play a crucial role and lead to severe damage and failure of multiple organs such as the skin, joints, tendons, gastrointestinal tract, lungs, heart, blood vessels, and kidneys. In SSc, the presence of ILD is even more common (≥80%); in addition, pulmonary hypertension (PH), also in the absence of diffuse lung disease, can be demonstrated by cardiac catheterisation in 10% of cases. These conditions are the two main prognostic factors for SSc patients; in fact 40% of deaths in SSc are attributable to pulmonary pathology (4).

CD25, the IL-2 receptor α chain, is one subunit of the high-affinity IL-2 receptor (IL2R), which is comprised of IL2R alpha (CD25), beta (CD122), and the common gamma chain (CD132). It is well known that soluble CD25 (sCD25) is generated as a consequence of proteolytic cleavage, mainly from the membrane of activated T cells, and the serum concentrations of sCD25 are associated with the proliferation of activated T cells. High serum sCD25 levels have been reported in patients with various autoimmune diseases. Previous studies have shown that sCD25 can act as an early inhibitor of T-cell response related to IL-2 signalling. In the experimental autoimmune encephalomyelitis (EAE) model, sCD25 can enhance the Th17 response and exacerbate EAE by prohibiting signalling by sequestering the local IL-2 and IL-2R interaction. sCD25 can efficiently bind to secreted IL-2, suggesting its ability to serve as a decoy receptor for IL-2 to play a pathogenic role in autoimmunity development.

Eligibility Criteria:
1. Inclusion criteria:

   SSc patients fulfilled the 2013 ACR/EU LAR criteria (10). Adult age above 18 years.
2. Exclusion criteria:

   * Patients unwilling to participate in the study.
   * Patients with other autoimmune diseases.
   * Patients with interstitial lung disease (ILD) caused by causes other than systemic sclerosis.
Prevalence of Replication of Human Herpes Virus 6 (HHV6) in Blood and Skin During Exanthemia, in Patients With Hemopathy. Is There a Correlation With the Etiology of the Exanthema?

To look for the replication of HHV6 by PCR in the skin, in these patients with haemopathies presenting an exanthema. This will make it possible to evaluate the prevalence of the positivity of this PCR in the skin. Then the investigator can investigate whether there is an association between the positivity of HHV6 PCR in the blood and / or skin and the viral etiology of the exanthema. If this association exists, it will make it possible to improve the diagnosis in the context of the exanthema and thus to improve the therapeutic management of these patients.


Eligibility Criteria:
Inclusion Criteria:

* Supported for any type of hemopathy.
* Allograft, autografted or ungrafted haematopoietic stem cells
* Having presented an exanthema during hospitalization, for which a cutaneous biopsy had been performed
* Having had a blood test of the HHV6 virus by PCR at least within the previous 40 days or following the rash.
* Age greater than or equal to 18 years
* Patient informed of the protocol by post, not having refused within one month of sending the said courier.

Exclusion Criteria:

* Patient who refused the search.
* Patient whose HHV6 PCR in the blood was carried out at a distance of more than 40 days from the skin biopsy.
TransForm™ Occlusion Balloon Catheter Registry

The primary objective of this registry is to collect real world data on the safety and performance of the TransForm™ Occlusion Balloon Catheter when used in current neurointerventional procedures

* This is a prospective, single-arm, non-randomized, multi-center, observational registry.
* The expected duration for study enrollment is approximately 6 months-1 year.
* Study participation for each subject will be completed upon removal of the guide catheter post-procedure.
* Up to 140 subjects will be enrolled at up to 15 study sites. A given site will be allowed to enroll a maximum of 20 subjects.
* Enrollment in the registry occurs after a signed Informed Consent Form has been obtained, and the index procedure starts.

Eligibility Criteria:
Inclusion Criteria:

1. Subject or legal representative is willing and has provided informed consent.
2. Subject is scheduled to undergo a neurointerventional procedure that may include the use of the occlusion balloon catheter.
3. Subject is over 18 years of age.

Exclusion Criteria:

1. Subject's anatomy precludes safe delivery of the TransForm Occlusion Balloon Catheter.
2. Subject's pregnant
Addressing Vaccine Acceptance in Carceral Settings Through Community Engagement

The goal of this study is to reduce morbidity and mortality from COVID-19 amongst people who are detained in and work in correctional facilities. The overall objective is to identify feasible and effective interventions to improve vaccine uptake in correctional facilities and study the effectiveness of these interventions through rapid cycle, cluster randomized trials in the Pennsylvania prison system.

Aim 1: To identify correctional system strategies to address COVID-19 and influenza vaccine acceptance amongst incarcerated people and correctional staff.

Aim 2: To select feasible strategies for a statewide correctional system at the patient-, provider-, practice- and prison-level to address COVID-19 and influenza vaccine uptake through a community engaged research approach.

Aim 3: To compare the effectiveness of interventions to address COVID-19 and influenza vaccine acceptance using a rapid cycle cluster randomized trial design in prison.

This study is highly innovative in its application of rapid cycle, cluster randomized trials in correctional systems to test the effectiveness of strategies identified using a community based participatory research approach. The results will serve as an evidence base for improving vaccine uptake that can be scaled nationally and adapted for other populations affected by the criminal legal system.

Eligibility Criteria:
Inclusion Criteria:

* All incarcerated people in the Pennsylvania DOC are included in the study population for these low risk interventions. In this each individual intervention, inclusion criteria will be based on where incarcerated people are housed and therefore what intervention they will be exposed to.

Exclusion Criteria:

* Exclusion criteria will likely include severe physical or mental illness as these individuals are often incarcerated in special units which will not be included in the study (i.e. medical units).
Microencapsulated Fish Oil or Conjugated Linoleic Acid in Metabolic Syndrome

Our aim was to assess the effects of a hypocaloric diet, including diet fruit jelly with microencapsulated fish oil or conjugated linoleic acid or placebo, on anthropometry, body composition, insulin resistance and lipid profile in women with metabolic syndrome and genotype Pro12Pro in the PPAR gamma 2 gene.


Eligibility Criteria:
Inclusion Criteria:

* adults women (30-45 years old);
* diagnosis of metabolic syndrome, as defined by the International Diabetes Federation;
* Pro12Pro genotype in gene PPARγ2.

Exclusion Criteria:

Participants were excluded if they:

* Were allergic to strawberries or fish
* Were pregnant or lactating
* Took fatty acid supplements
* Had undergone bariatric surgery or were being treated nutritionally or pharmacologically for reducing BM, or had taken anti-obesity drugs during the previous three months
Telehealth for Pain and Unhealthy Drinking Among PLWH

This randomized controlled trial is a between-groups design to compare the Motivational and Cognitive Behavioral Management for Alcohol and Pain (MCBMAP) Intervention to a Brief Advice and Information Control condition.

Two-hundred and fifty participants who have HIV with moderate or greater chronic pain will be randomized for the trial. Recruitment will take place through digital media. A unique feature of this intervention trial is that most of the procedures will be conducted remotely which will minimize barriers of transportation and time for participants. Consent and baseline assessment will be completed remotely. Following baseline assessment, participants will complete two weeks of ecological momentary assessment (EMA) to assess alcohol use, chronic pain, physical function and mechanisms of behavior change for alcohol and pain management. Following the two-week phase, participants will be randomly assigned to either the intervention or control condition and meet the interventionist through videoconferencing. Participants will complete outcome assessment measures at 3- and 6-months post-baseline. Following the 3-month outcome assessment, participants will complete another two weeks of EMA.


Eligibility Criteria:
Inclusion Criteria:

* Able to confirm HIV diagnosis, via visual evidence of antiretroviral (ART) medication bottle or medical record presented to study staff over Zoom.
* Engaged in unhealthy drinking, defined as:
* \>7 drinks for women / \> 14 drinks for men per week.
* OR ≥ 3 drinks for women / ≥4 drinks for men on one occasion in the past month.
* Experiencing moderate or greater chronic pain (4 or greater on the numerical pain rating scale) for at least 3 months.
* Own a smart phone.
* Lives in the USA.
* Has a US mailing address.

Exclusion Criteria:

* History of bipolar, schizoaffective disorder or schizophrenia per self report.
* Unstable dose of psychoactive medication for pain or alcohol/substance use \[i.e., if on medication, participant has not been on same dose for least 2 months\]
* History of withdrawal-related seizures or delirium tremens
* Current non-pharmacological treatment for alcohol use disorder or chronic pain
* Acute life-threatening illness that requires treatment or intend to have surgery for a pain-related condition in the next 6-months.
* Current cancer-related pain
* Unable to provide one or more individuals for follow-up contact
* Individual who is unwilling to provide their sex at birth
* Limited or non-readers
Inhaled Steroids at Discharge After Emergency Department Visits for Children With Uncontrolled Asthma

Many children have asthma and this causes problems with their health. A lot of children with uncontrolled asthma use emergency departments for asthma care, and so this is an ideal place for an intervention for these children. One intervention is prescribing inhaled steroids to children with uncontrolled asthma, but currently this is rarely done in the emergency department. Inhaled steroids have been shown to be good at making children better long-term when they have uncontrolled asthma.

This study identifies children in the emergency department with uncontrolled asthma using a tool called the Pediatric Asthma Control and Communication Instrument (PACCI). If children meet criteria for uncontrolled asthma they will be randomly assigned to either: 1) routine asthma care which includes close follow up with their doctor or 2) prescribing of an inhaled corticosteroid from the emergency department. The investigators hypothesize that children who are prescribed inhaled steroids for uncontrolled asthma from the emergency department will have better 6 month asthma control than children who receive routine asthma care.

Specific aim 1 - An ED-based RCT to determine if ICS prescription in children identified using the PACCI as having uncontrolled asthma results in less asthma morbidity compared to routine asthma care. We hypothesize that children receiving ICS prescriptions will have fewer unscheduled health care use for asthma exacerbations (doctor's office visits, ED visits, or hospitalizations), and greater quality of life.

Specific aim 2 - Thematic analysis of interviews with parents who are adherent versus non-adherent with ICS prescription filling and use to determine the factors associated with adherence. We hypothesize that factors will include: 1) Parent beliefs about the chronic versus episodic nature of asthma, 2) Parent's knowledge of benefits and risks of ICS, and 3) Provision and use of an asthma action plan.

Eligibility Criteria:
Inclusion Criteria:

* 3 - 12 years of age
* child has asthma diagnosed by a doctor based on parental/caregiver report
* child is not already properly using an ICS or being discharged with an ICS

Exclusion Criteria:

* The child has previously participated in this study
* The child has major co-morbid disease of the heart or lungs (examples include cystic fibrosis, heart disease, muscular dystrophy and cerebral palsy with immobility. It does not include allergic rhinitis or a history of respiratory infections such as pneumonia or bronchiolitis.
* The child's parents/caregivers do not speak English
* The child is not going to be discharged from the emergency department (e.g. hospitalization)
Pharmacogenomics Effects on High-Dose Methotrexate Clearance in Patients With Diffuse Large B-Cell Lymphoma

This study evaluates pharmacogenomic effects on high-dose methotrexate clearance in patients with diffuse large B-cell lymphoma.

PRIMARY OBJECTIVES:

I. To identify SNPs associated with delayed MTX clearance. II. To explore any association between SNPs and increased toxicity.

OUTLINE: This is an observational study.

Participants undergo blood sample collection and have their medical records reviewed on study.

Eligibility Criteria:
Inclusion Criteria:

* \* Adult (age ≥ 18 years at diagnosis)

  * Diagnosis of DLBCL or PCNSL
  * Planned to undergo treatment with HDMTX (≥ 3 g/m\^2) at the James Cancer Hospital.

Note: patients with CKD are eligible to participate regardless of eGFR provided the treating physician is planning a dose of HDMTX of at least 3 g/ m\^2.

* Ability to provide informed consent.

Exclusion Criteria:

* \* Patients with a "currently active" second malignancy that, in the opinion of the principal investigator, will interfere with patient participation, or confound data interpretation

  * Pregnancy (positive serum or urine pregnancy test), lactating or breast feeding
  * Prisoners or incarcerated patients
  * Total bilirubin \> 5 mg/dL