cyrilzakka/clinical-trials huggingface dataset:
Role of Exogenous and Endogenous Sex Hormones on Tenofovir and Emtricitabine Disposition in Female Genital Tract

Cervical biopsies will be collected from women aged 18 and over whom are virally suppressed and taking tenofovir as part of their antiretroviral therapy regimen. Blood plasma, peripheral blood mononuclear cells (PBMC), and cervicovaginal swabs will also be collected. Drug concentrations, hormone concentrations, inflammatory cytokines, and vaginal microbiome will be evaluated to understand the role of hormones, inflammation, and the microbiome in modulating drug efficacy in the female genital tract.


Eligibility Criteria:
Inclusion Criteria:

1. Female, or transgender female with a cervix, age 18 years or older
2. HIV-positive
3. Stable on antiretroviral regimen containing tenofovir or emtricitabine for at least 2 weeks at time of enrollment.
4. Virally suppressed (HIV-RNA copies \<50 copies/mL) for at least 6 months at time of enrollment.
5. Willing to refrain from vaginal intercourse and use of vaginal devices such as douches and sex toys within 72 hours of the biopsy visit.
6. Willing and able to give signed informed consent.
Hidradenitis Suppurativa Study of Izokibep

Izokibep is a small protein molecule that acts as a selective, potent inhibitor of interleukin 17A, to which it binds with high affinity. This study investigates izokibep in participants with active Hidradenitis Suppurativa (HS), including tumor necrosis factor-alpha inhibitor (TNFi) naïve participants, and those who had an inadequate response or intolerance to TNFi, or for whom TNFi is contraindicated.


Eligibility Criteria:
Inclusion Criteria:

General

* Participant has provided signed informed consent including consenting to comply with the requirements and restrictions listed in the informed consent form (ICF) and in protocol
* 18 years of age or older
* No known history of active tuberculosis unless adequately treated according to World Health Organization/Center for Disease Control and Prevention therapeutic guidance and determined to be fully recovered by a tuberculosis specialist

Type of Participant and Disease Characteristics

* Diagnosis of HS for ≥ 6 months prior to first dose of study drug
* Hidradenitis suppurativa lesions present in ≥ 2 distinct anatomic areas, one of which is Hurley Stage II or Hurley Stage III
* A total AN count of ≥ 5 at screening and Day 1 prior to enrollment/randomization
* Participant must have had an inadequate response to oral antibiotics OR exhibited recurrence after discontinuation to, OR demonstrated intolerance to, OR have a contraindication to oral antibiotics for treatment of their HS
* Must agree to use daily or a minimum of 3 days a week over-the-counter topical antiseptics
* Participant must be willing to complete a daily skin pain diary

Exclusion Criteria:

Medical Conditions

* Draining fistula count of \> 20
* Outpatient surgery ≤ 8 weeks prior or inpatient surgery ≤ 12 weeks prior to enrollment/randomization
* Other active skin disease or condition that could interfere with study assessments
* History of active inflammatory bowel disease (IBD) OR symptoms within the last year that may be suggestive of IBD
* Chronic pain not associated with HS
* Uncontrolled, clinically significant system disease
* History of demyelinating disease or neurological symptoms suggestive of demyelinating disease
* Malignancy within 5 years
* The participant is at risk of self-harm or harm to others
* Active infection or history of certain infections
* Tuberculosis or fungal infection seen on available chest x-ray taken within 3 months prior to first dose of study drug or at screening (Exception: documented evidence of completed treatment and clinically resolved)
* Known history of human immunodeficiency virus (HIV)

Other protocol defined Inclusion/Exclusion criteria may apply
Intervention to Improve Caregiver Palliative Care Knowledge and Attitudes

This randomized clinical trial will assess whether a psychoeducational intervention will improve palliative care knowledge and attitudes among close friends and family members of individuals with cancer. The psychoeducational intervention entails viewing a video introducing palliative care and its purpose, structure, benefits, and efficacy.

The primary aims of this randomized clinical trial are to examine the impact of a psychoeducational intervention on (1) palliative care knowledge, and (2) palliative care attitudes among close friends and family members of individuals with cancer. Participants will complete a baseline survey including measures of palliative care knowledge and experience. Participants will be randomized to then view either a psychoeducational video introducing palliative care (intervention) or an educational video on nutrition throughout cancer survivorship (attention control). All participants will then complete outcome measures, including primary outcomes of palliative care knowledge and attitudes.

Eligibility Criteria:
Inclusion criteria:

* Provide informed consent
* 18 years of age or older
* Have ever had a close friend or family member diagnosed with cancer
A Study Of The Effect Of CE-224535 On Knee OA (Osteoarthritis) Pain

CE-224535 is a new medication being developed as an analgesic and anti-inflammatory agent for the treatment of the signs and symptoms of osteoarthritis (OA). The purpose of this study is to evaluate the analgesic and anti inflammatory efficacy and safety of CE 224,535 versus placebo and naproxen treatment in patients with OA knee pain.


Eligibility Criteria:
Inclusion Criteria:

* Is a healthy adult 18 to 75 years of age, inclusive, in general good health and with diagnosis of knee OA, as determined by the American College of Rheumatology (ACR) clinical/radiographic classification criteria for OA of the knee.
* Women must be of non childbearing potential (amenorrhea for at least 1 year PLUS have a serum follicle stimulating hormone (FSH) level \>30 IU/L, bilateral oophorectomy or hysterectomy), and have a confirmed negative serum pregnancy test at the screening visit prior to randomization.

Exclusion Criteria:

* History of other diseases that may involve the study joint, including inflammatory joint diseases, crystalline disease, endocrinopathies, metabolic diseases, infections, neuropathic disorders, avascular necrosis, Paget's disease, or tumors.
* Women of childbearing potential, or who are pregnant or lactating.
Long Term Survivors in Ovarian Cancer

In this study the investigators would like to explore the patient and tumour characteristics of long-term survivors of ovarian cancer (\>10 years). Indentifiying the characteristics of long-term survivors not only helps find prognostic factors for survival but may aid in generating hypotheses for novel therapeutic strategies.


Eligibility Criteria:
Inclusion Criteria:

To achieve a large enough study population of approximately 80 subjects, patients surviving \>10 years after treatment for stage IIIC/IV epithelial ovarian cancer in the past 25 years will be included from five hospitals. Patients were diagnosed between 1979 and 2006 and treated in the north of the Netherlands. A list of subjects fitting these inclusion criteria will be extracted from the National Cancer Registry (NKR).
Patients Pregnant Women With or Without Primary Antiphospholipid Antibody Syndrome

The purpose of the study is to evaluate the ability of placental angiogenesis markers to predict the risk of PE in pregnancy in women with primary APS.

To construct reference intervals of placental angiogenesis markers specific to women affected by primary APS in pregnancy by measuring the levels of sFlt-1and PlGF in serum maternal serum and their sFlt-1/PlGF ratio during the trimesters of gestation (I TM, II TM and III TM).

For this aim the study will involve recruiting two groups of subjects, one will be cases and one will be controls.


Eligibility Criteria:
Inclusion Criteria:

* Group 1

  1. Pregnant patients between the ages of 18 and 45 years.
  2. Diagnosis of primary APS, according to international classification criteria.
* Group 2

  1. Pregnant patients between the ages of 18 and 45 years.
  2. Patients with at least one previous full-term pregnancy.
  3. No diagnosis of APS, according to international classification criteria.

Exclusion Criteria:

* Group 1

  1. PMA pregnancies.
  2. Known chronic pathology in gestational period such as chronic essential hypertension, neurological pathology
  3. Previous thrombotic event
  4. Chronic renal failure not related to AD
  5. Previous history of oncology
* Group 2

  1. Pregnancy by PMA.
  2. Previous history of polyabortion and/or late pregnancy complications.
  3. Known chronic pathology in gestational period such as chronic essential hypertension, neurological pathology
  4. Previous thrombotic event
  5. Previous history of oncology
Registry of Translarna (Ataluren) in Nonsense Mutation Duchenne Muscular Dystrophy (nmDMD)

This study is being performed as a post-approval safety study (PASS), per the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA), to gather data on Translarna (ataluren) safety, effectiveness, and prescription patterns in routine clinical practice.

This is a multicenter, observational study of participants receiving Translarna based on inclusion of their data in a registry. This study is intended to enroll 360 participants across \~50 care centers in Europe and other regions over a period of \~ 2 years. The study population will include participants who are receiving usual care treatment with commercial supply of Translarna (or receiving care within a named participant early access program) and who provide consent. Participants will be followed for at least 5 years from their date of enrollment. Safety and efficacy data will be collected in conjunction with routine visits conducted as per usual care. Although there are no protocol-mandated procedures, it is expected that physicians and other caregivers will follow published treatment guidelines and standards of care.

Eligibility Criteria:
Inclusion Criteria:

* Receiving or will be receiving usual care treatment with commercial supply of Translarna (or receiving care within a named participant early access program)
* Willing to provide written informed consent to allow the study data collection procedures (either by the participant or through authorisation by a legal guardian)

Exclusion Criteria:

* Participants who are receiving ataluren or placebo in a blinded, randomized clinical trial, or ataluren in any other ataluren clinical trial or cohort early access program that prevents participation in this study
Study of Adalimumab in Subjects With Moderate to Severe Chronic Hidradenitis Suppurativa

This study will investigate how well adalimumab works in people with hidradenitis suppurativa (HS) in the short and long term.

This Phase 2 randomized, double-blind, placebo-controlled multicenter study consists of 2 treatment periods: a 16-week double-blind, placebo-controlled period (Period 1: Weeks 0 through the end of Week 15) followed by a 36-week open-label period (Period 2: Weeks 16 through 52). Participants are randomized in a 1:1:1 ratio based on Hurley Stage as stratification factor to receive adalimumab 40 mg every week (qwk), adalimumab 40 mg every other week (eow), or matching placebo during Period 1. During Period 2, participants receive open-label adalimumab 40 mg eow with the option to escalate to 40 mg weekly dosing at Week 28 or Week 31 if the participant has a Physician's Global Assessment of moderate disease or worse (score of greater than or equal to 3). The primary objective of the study is to determine the clinical efficacy and safety of participants with moderate to severe chronic hidradenitis suppurativa (HS) after 16 weeks of treatment. The secondary objective is to evaluate the maintenance of efficacy and continued safety of adalimumab for an additional 36 weeks of treatment. (Note: Hurley Stage is a classification system for skin involvement that is largely based on the presence and extent of abscess formation accompanied by scarring and sinus tracts. Hurley Stages are I \[abscess formation without scarring and sinus tracts\], II \[widely separated recurrent abscesses with scarring and sinus tracts\], and III \[multiple interconnected abscesses and sinus tracts across entire area\]. Randomization in this study was performed using stratification by Hurley Stage \[III versus (I or II).) At the present time, Period 1 double-blind data only is provided; additional information will be provided when analysis of open-label Period 2 is completed.

Eligibility Criteria:
Inclusion Criteria:

* Adults with stable, moderate to severe hidradenitis suppurativa
* Negative Chest X-ray and PPD test at Screening. If participant has had a past ulcerative reaction to PPD placement and/or chest X-ray consistent with prior tuberculosis exposure, the participant must initiate, or have documented completion of, a course of anti-tuberculosis therapy.
* Ability to administer subcutaneous injections
* General good health otherwise

Exclusion Criteria:

* Prior anti-TNF therapy
* Unstable antibiotic therapy for HS
* Required medication washouts for other HS treatments
* Prior exposure to Tysabri® (natalizumab);
* Recent infection requiring treatment
* Significant medical events or conditions that may put patients at risk for participation
* Female subjects who are pregnant or breast-feeding or considering becoming pregnant during the study;
* History of cancer, except successfully treated skin cancer
* Recent history of drug or alcohol abuse
Efficacy of a Self-test and Self-alert Mobile Applet in Detecting Susceptible Infection of COVID-19

The "COVID-19 infection self-test and alert system" (hereinafter referred to as "COVID-19 self-test applet") jointly developed by Beijing Tsinghua Changgung Hospital, Institute for precision medicine, artificial intelligence of Tsinghua University was launched on February 1，2020. Residents , according to their actual healthy situation, after answering questions online, the system will conduct intelligent analysis, make disease risk assessment and give healthcare and medical guidance. Based on the Internet population survey, and referring to the diagnosis and screening standards of the National Health Commission of the People's Republic of China, investigators carried out the mobile applet of Internet survey and registry study for the Internet accessible identifiable population, so as to screen the suspected population and guide the medical treatment.

The "COVID-19 infection self-test and alert system" (hereinafter referred to as "COVID-19 self-test applet") jointly developed by Beijing Tsinghua Changgung Hospital, Institute for precision medicine, artificial intelligence of Tsinghua University was launched on February 1，2020. This survey was also advocated by Chinese Medical Doctor Association. Residents , or even oversea Chinese people，according to their actual healthy situation, after answering questions online, the system will conduct intelligent analysis, make disease risk assessment and give healthcare and medical guidance. Based on the Internet population survey, and referring to the diagnosis and screening standards of the National Health Commission of the People's Republic of China, investigators carried out the mobile applet of Internet survey and registry study for the Internet accessible identifiable population, so as to screen the suspected population and guide the medical treatment.

Eligibility Criteria:
Inclusion Criteria:

* people who lived in or out of China at present and threatened by the infection and spread of COVID-19

  * without gender and age restriction
  * people who have concerns of his health
  * voluntary completion of the self-test and evaluation.

Exclusion Criteria:

* people who are not internet accessible or can not use this Mobile Applet.
* people who can not recognize the questionnaire.
The Use of STOPP/START Criteria for Medication Intervention Among Elderly Population Living in a Geriatric Hospital

The purpose of this study is to determine if the use of STOPP/START criteria (STOPP-screening tool of older persons potentially inappropriate prescriptions START-screening tool to alert doctors to right treatment)for medication intervention in elderly population living in a geriatric hospital will lower the number of falls,hospitalization,will improve functioning, quality of life and reduce financial costs.

Inappropriate prescribing is common in older people and is associated with adverse drug effects,hospitalization and falls. In this trial we want to check the efficacy of the screening tools STOPP/START which were developed and validated in order to reduce inappropriate prescribing. STOPP comprises of 65 indicators of drug-drug, drug-disease interactions and therapeutic duplication. START incorporates 22 evidence based indicators of common prescribing omissions. We will conduct a randomized controlled trial to test the hypothesis that screening the medications of older patients living permanently in a geriatric hospital will improve their quality of life. The compliance of the doctor working in the geriatric hospital to the recommendations of the screening tools will also be checked.

Eligibility Criteria:
Inclusion Criteria:

* age over 65
* live in the geriatric hospital "Givaat Hashlosha" permanently.

Exclusion Criteria:

* people with a terminal illness that will not live more than a year.
* people who enter the geriatric hospital for a short while (are not permanent).
Effect of Mother DHA Supplementation on Term Newborn.

In the present study, we evaluate the effect of the mother suplementación with DHA during the gestation and lactation on diverse aspects of the development of newborn. The effect on the oxidative stress, inflammatory signaling, bone turnover and piscomotor and visual development was studied. Women will in the sixth month of pregnancy, consume a diet balanced during last 3 months of pregnancy and the whole lactation. In addition the women will divide in two groups: one will receive a supplement of docosahexaenoic acid (DHA) to evaluate the effects on the development of the newborn child; whereas another group will receive a placebo. Different samples of blood of the mother and of mother milk will be taken and we will correlating her lipidic profile with the brain development of the newborn child, evaluated by different tests.

The sample will be 120 volunteers that will be enrolled in the services of Gynaecology of the infantile Hospital of Granada. The pregnant women will be assigned from random form to one of 2 groups that are described later:

Group A: balanced diet Mediterranean, intake of 2 glasses / day of the dairy drink control.

Group B: balanced Mediterranean diet together with the consumption of 400mg/day of DHA in the dairy product (2 glasses / day). The dairy products will be distributed in white packages without any indication that reflects the type of product that contains (double blind). Every volunteer will be assigned a key that guarantees the confidentiality of their analytical values.

The dietary intervention will begin in the sixth month of pregnancy and will conclude to the third month of lactation (though there will improve itself the importance of a mother lactation up to 6 month postpartum). There will be obtained samples of blood (5 mL) of the mothers in the moment of the capture, in the childbirth and to 3 postpartum months. There will take a sample of blood of umbilical cord (5mL) in the moment of the childbirth (vein and artery). In addition there will take a sample of blood of the child (5mL) to 2.5 months. There will take also samples of mother milk (10mL), concretely of colostrum (2-3 postpartum days) and of mature(ripe) milk to 1, 2, 3 months. The samples will be preserved in freezer of-80ºC and sent to the different laboratories due preserved participants in order that there does not break the cold chain ( dry ice). In the first year of life of the child there will be practised tests of motive and cognitive development (Bayley's test and Fagan's test) in order to evaluate the influence of the dietetic intervention on the mother in the development of the child.

Eligibility Criteria:
Inclusion Criteria:

1. Consent
2. mother with normal gestation.

Exclusion Criteria:

1. Risk factors during gestation.
2. Lactose intolerance
3. systemic illness.
4. Kwashiorkor.
5. Metabolic illness.
6. Foetal pathologies
Post-marketing Surveillance of Berodual® Metered-dose Inhaler in the Treatment of Chronic Obstructive Respiratory Tract Disease

The aim of this post-marketing surveillance is to obtain further information about the tolerability of Berodual® metered-dose inhaler in the treatment of chronic obstructive respiratory tract disease under conditions of daily practice


Eligibility Criteria:
Inclusion Criteria:

* Patients with diagnosis of Chronic obstructive respiratory tract disease
* Patients of either sex, including children over 6 years

Exclusion Criteria:

- Contraindications listed in the Instructions of Use/Summary of Product Characteristics of Berodual® metered-dose inhaler
Vitamin D and Chronic Obstructive Lung Disease

The purpose of this study is to examine the effect of vitamin D intervention in patients with chronic obstructive pulmonary disease (COPD) undergoing rehabilitation.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 50 years
* Diagnosed COPD with forced expiratory volume in 1 second (FEV1) \< 50 % of predicted
* Breathlessness relative to MRC dyspnoea grade 3 or more

Exclusion Criteria:

* Patients with known diseases of bone metabolism apart from osteoporosis and patients with granulomatous disease
* Patients with hyper- or hypocalcemia at inclusion
* Patients with cardiovascular or musculoskeletal disease that impacts significantly on walking based on the investigator's judgement
* Patients with dementia or other mental conditions rendering them unable to understand the study information and thus provide informed consent
* Patients with terminal disease or known cancer with bone metastases, increasing their risk of hypercalcemia
* Patients taking more than 20 mcg vitamin D on a daily basis. If a patient takes vitamin D below this limit, dose should have been stable 6 months prior to inclusion in order to achieve steady-state.
* Pregnancy