cyrilzakka/clinical-trials huggingface dataset:
Sickness Absence Versus Physical, Mental, and Job-related Factors in Patients With Chronic Pulmonary Disease

People with chronic respiratory disease have shortened work life, their disease is associated with greater work disability and they are at greater risk of being unemployed. Lower employment rates and higher sickness absence is expensive for the community and leads to financial as well as social consequences for the individual.

There is a lack of data on factors that can predict sickness absence and disability in patients with pulmonary disease. We therefore want to study a group of people with COPD and asthma referred to our clinic. The study will investigate relationships between sickness absence and exercise capacity, job-related factors, disease severity, self-efficacy, health related quality of life and subjective health complaints.


Eligibility Criteria:
Inclusion Criteria:

* chronic pulmonary disease
* employed
* periods of sickness absence in the year prior to admittance

Exclusion Criteria:

* lack of ability to complete the rehabilitation program
Clinical Outcomes of Two Symmetrical Kera-rings Implantation in Grade Three Keratoconus

Clinical Outcomes of Two Symmetrical Kera-rings Implantation in Grade Three Keratoconus

a retrospective non- randomized controlled clinical study. The study included twenty-three grade 3 keratoconic eyes of twenty-three patients, the keratoconus staging was based on Amsler-Krumeich classification The ICRS surgery was performed with the patient under topical anesthesia. A tunnel channel was created by femtosecond laser using a 60-kHz infrared neodymium glass femtosecond laser at a wavelength of 1053 nm (Abbott Laboratories Inc., Abbott Park, Illinois, USA). Two symmetrical kerarings (Mediphacos Inc., Belo Horizonte, Brazil), were implanted in all cases with 160° arc and 0.25, 0.30 mm according to corneal thickness in implantation site. After surgery, the patients had a full ocular evaluation on days 1, 7, and 14, and again after a month. For a period of 1-year, corneal topography readings were taken quarterly.

Eligibility Criteria:
Inclusion Criteria:

* stable keratoconus.
* corneal cross-linking performed at least 6 months.
* contact lens intolerance
* minimum corneal thickness of 350 μm at the thinnest point (TP)
* mean keratometry (K mean) value less than 59 D

Exclusion Criteria:

* any other associated ocular or systemic pathology could affect the vision.
Phase 1b Study of VERVE-201 in Patients with Refractory Hyperlipidemia

VT-20101 is an Open-label, Phase 1b, Single-ascending dose study that will evaluate the safety of VERVE-201 administered to patients with Refractory Hypercholesterolemia.

VERVE-201 uses base-editing technology designed to inactivate the expression of the ANGPTL3 gene in the liver and lower circulating low-density lipoprotein cholesterol (LDL-C). This study is designed to determine the safety and pharmacodynamic profile of VERVE-201 in this patient population.


Eligibility Criteria:
Inclusion Criteria:

* Refractory hypercholesterolemia
* Females of non-childbearing potential or males

Exclusion Criteria:

* Active or history of chronic liver disease
* Current treatment with monoclonal antibody targeting ANGPTL3 or prior treatment within specified timeframe
* Clinically significant or abnormal laboratory values as defined by the protocol
Negative Pressure Therapy, Minimally Invasive and Accessible Technique in the Treatment of Massive Subcutaneous Emphysema in COVID-19 or Non Infected Critical Patients

Background Numerous surgicals treatments have been described for the massive subcutaneous emphysema; however, some of these techniques cannot be carried out in a critical care unit and they are related with high morbidity and exposure in positive SARS COV-2 patients. More effective, less invasive and isolated procedures should be implemented.

Technique Negative pressure therapy (NPT) that can allow effective solving of massive subcutaneous emphysema in a short period (5 days) with a minimally invasive approach at the bedside in Covid-19 or non infected critical patients.

Conclusion NPT is an effective and low invasive strategy for the management of EES in critical patients with high risk of mortality.


Eligibility Criteria:
Inclusion Criteria:

* Subcutaneous emphysema that compromises ventilation

Exclusion Criteria:

* Declined Therapy
A Study Of Lorlatinib Versus Crizotinib In First Line Treatment Of Patients With ALK-Positive NSCLC

A phase 3 study to demonstrate whether lorlatinib given as monotherapy is superior to crizotinib alone in prolonging the progression-free survival in advanced ALK-positive NSCLC patients who are treatment naïve and to compare lorlatinib to crizotinib with respect to overall survival in the same population


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of locally advanced or metastatic ALK-positive NSCLC; at least 1 extracranial measurable target lesion not previously irradiated. CNS metastases allowed if asymptomatic and not currently requiring corticosteroid treatment.
* Availability of an archival FFPE tissue specimen.
* No prior systemic NSCLC treatment.
* ECOG PS 0, 1, or 2.
* Age ≥18 years .
* Adequate Bone Marrow, Liver, Renal, Pancreatic Function
* Negative pregnancy test for females of childbearing potential

Exclusion Criteria:

* Spinal cord compression unless good pain control attained
* Major surgery within 4 weeks prior to randomization.
* Radiation therapy within 2 weeks prior to randomization, including stereotactic or partial brain irradiation. Whole brain irradiation within 4 weeks prior to randomization
* Active bacterial, fungal, or viral infection
* Clinically significant cardiovascular disease, active or within 3 months prior to enrollment. Ongoing cardiac dysrhythmias, uncontrolled atrial fibrillation, bradycardia or congenital long QT syndrome
* Predisposing characteristics for acute pancreatitis in the last month prior to randomization.
* History of extensive, disseminated, bilateral or presence of Grade 3 or 4 interstitial fibrosis or interstitial lung disease
* Active malignancy (other than NSCLC, non melanoma skin cancer, in situ cervical cancer, papillary thyroid cancer, LCIS/DCIS of the breast, or localized prostate cancer) within the last 3 years prior to randomization.
* Concurrent use of any of the following food or drugs within 12 days prior to the first dose of lorlatinib or crizotinib.

  1. known strong CYP3A inhibitors .
  2. known strong CYP3A inducers
  3. known P gp substrates with a narrow therapeutic index
* Concurrent use of CYP3A substrates with narrow therapeutic indices within 12 days prior to the first dose of lorlatinib or crizotinib.
* Other severe acute or chronic medical or psychiatric condition, including recent or active suicidal ideation or behavior, or laboratory abnormality that may increase the risk associated with study participation or interfere with the interpretation of study results
* Investigational site staff members directly involved in the conduct of the study and their family members, or Pfizer employees, including their family members, directly involved in the conduct of the study.
* Participation in other studies involving investigational drug(s) within 2 weeks prior to study entry and/or during study participation.
Study of Hydroxychloroquine in Patients With X-linked Alport Syndrome in China (CHXLAS)

This Phase 2 randomized controlled trial will study the safety, tolerability, and efficacy of Hydroxychloroquine in qualified patients with Alport syndrome. The trial will be open-label, randomized, controlled and will enroll up to 50 patients.

This Phase 2 randomized controlled trial will study the safety, tolerability, and efficacy of Hydroxychloroquine in qualified patients with Alport syndrome. The trial will be open-label, randomized, controlled and will enroll up to 50 patients.

Patients in the Phase 2 cohort will be randomized 1:1 to either Hydroxychloroquine Cohort or Comparator Cohort.

All patients in the study will follow the same visit and assessment schedule. Following randomization on Day 1, patients will be scheduled to be assessed during treatment at Weeks 4, 12, and 24. Patients will not receive study drug during a 24-week withdrawal period between Weeks 25 and 48. Patients will also be scheduled to be assessed at an in person follow up visit at Week 36, and 48.

Eligibility Criteria:
Inclusion Criteria:

* Male or female;
* Age 3-18 years old;
* Diagnosis of Alport syndrome by genetic testing (documented mutation in a gene associated with Alport syndrome, including COL4A3, COL4A4, or COL4A5) or histologic assessment using electron microscopy;
* Screening eGFR ≥ 90 mL/min/1.73 m2;
* ACE inhibitor and/or ARB, the dosing regimen should be stable for at least 4 weeks prior to screening;
* No antirheumatic drugs such as hydroxychloroquine have been used;
* Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures;

Exclusion Criteria:

* Causes of chronic kidney disease aside from Alport syndrome (including but not limited to other heritable disorders leading to chronic kidney disease, diabetic nephropathy, hypertensive nephropathy, lupus nephritis, IgA nephropathy);
* Prior exposure to hydroxychloroquine;
* Ongoing chronic hemodialysis or peritoneal dialysis therapy;
* Renal transplant recipient;
* Any clinically significant illness within 4 weeks before screening or surgical or medical condition (other than Alport syndrome) that could interfere with the subject's study compliance; confound the study results; impact subject safety; or significantly alter the absorption, distribution, metabolism, or excretion of drugs;
* Participation in other interventional clinical studies;
* Known hypersensitivity to any component of the study drug.
Evaluation of Excessive UV Irradiation on Skin Aging by Multiphoton Laser Imaging and Biophysical Methods

In this study, test persons with chronic excessive UV radiation and a control group are examined by multiphoton laser imaging and biophysical methods in order to evaluate the dermal fiber network. We expect to observe signs of advanced skin aging in the test group.


Eligibility Criteria:
Inclusion Criteria:

* non smokers
* contraception
* 12 subjects with chronic excessive UV irradiation
* 12 normal subjects

Exclusion Criteria:

* dermatological and other severe disorders
* pregnancy and lactation
* dermatological topical therapy
* internal medication
* cosmetical intervention at test area
Technical Feasibility Study of Ultrasound Muscle Imaging in Antenatal Ultrasound

The objective of the study is to evaluate the performance of muscle ultrasound sections on antenatal ultrasound between 21-24 amenorrhea weeks for the screening of muscle atrophy, in a sample of low-risk and high-risk pregnancies of congenital multiple arthrogryposis

Frequent rare diseases (100-200 births in France / year), congenital multiple arthrogryposis include a set of pathologies characterized by the limitation of joint movements at least two joint levels.Their functional prognosis and muscle atrophy are often severe after birth.

Routine ultrasound call signs are either non-specific or insensitive and difficult to detect due to time constraints. Antenatal ultrasound screening is not very effective for these pathologies, which are often particularly serious.

The main criterion will be the success rate of realization of all four ultrasound sections at the extremities (deltoide, biceps, quadriceps, triceps) and measurements of the distances "skin - muscle fascia" and "muscular fascia - periosteum" between 21-24 amenorrhea weeks

Eligibility Criteria:
Inclusion Criteria:

* Any pregnant woman consulting in one of the two obstetric gynecology departments in connection with the CPDPN (Multidisciplinary Prenatal Diagnostic Centers) of the University hospitals of Lyon or Grenoble.
* Mono-embryonic pregnancy.
* Gestational ages retained on the first dating ultrasound or the 1st trimester ultrasound between 21-24 amenorrhea weeks.
* For women at "high risk": diagnosis during ultrasound of the 1st, 2nd, or 3rd trimesters, of an abnormality of position / deformation of one or more joints, and / or an abnormality of fetal movements on screening ultrasound or interrogation (population group at "high risk of AMC").
* Regulatory criteria: adults, affiliated to a social security scheme, having signed a consent

Exclusion Criteria:

* Multiple pregnancies, and / or non-progressive .
* Obese women (BMI \> 30 in early pregnancy)
* Subject in a period of exclusion from another study
* Subject under administrative or judicial supervision
* Subject who cannot be contacted in case of emergency
COVID-19 and Pregnancy: Placental and Immunological Impacts

The aim of this study is to compare placental pathologies in patients with COVID 19 infection at the time of childbirth or a history of COVID 19 during pregnancy versus control patients

The second wave of COVID 19 is currently sweeping through Europe. If the first wave brought reassuring elements on the risk of maternal-fetal transmission, it nevertheless counted an increase in severe maternal forms in the third trimester associated with more premature deliveries and cesarean sections. In addition, due to the very recent nature of this new infection, we have little data on the effect of SARS-COV 2 contracted during pregnancy on the fetus and on maternal-fetal exchanges.

Publications report an increase in growth retardation, maternal coagulopathies, preeclampsia and placental thrombosis. The vascular placental abnormalities observed in the first series must be confirmed and refined. Finally, pregnancy is marked by immunomodulation which can interfere with immune reactions. A better understanding of the immunological mechanisms in the mother and of the immunity transmitted to the fetus is necessary to better understand the maternal-fetal issues of COVID 19.

This prospective study concerns patients presenting for their delivery at Foch Hospital.

4 groups of patients will be identified in the delivery room after childbirth based on their COVID 19 PCR taken within 72 hours, their COVID 19 serology, or a history of positive COVID 19 PCR during pregnancy : 1 control group of 50 patients, 1 group of 50 asymptomatic patients, 1 group of 50 patients with symptoms, and 1 group of 50 cured patients who contracted the disease during pregnancy. The patients will have various samples: blood, umbilical cord blood, umbilical cord, placenta

Eligibility Criteria:
Inclusion Criteria:

* Patient pregnant for more than 20 weeks with amenorrhea
* Having completed a COVID 19 PCR within 72 hours
* Admitted to the birthing room at Foch hospital for her delivery

Exclusion Criteria:

* Minor (age \<18 years, on inclusion)
* Diabetes with and without insulin (only for the control group)
* High blood pressure (only for the control group),
* Preeclampsia (only for the control group)
* Infection during pregnancy: HIV, toxoplasmosis, rubella, CMV, syphilis.
* PCR Influenza A or B positive, proven by nasopharyngeal swab in the week preceding childbirth
Motiv82Change: an HIV Prevention Study for Young Latino Men

The purpose of this study is to develop and pilot test a culturally and developmentally tailored Motivational Enhancement Intervention (MEI) to reduce risky sex (unprotected anal sex and multiple partners) among young Hispanic men who have sex with men (YHMSM).

Stage 1, divided into Stage 1a and Stage 1b, focuses on development, refinement, and pilot testing of interventions. The formative research leading to and including intervention development is completed in Stage 1a. A pilot study to provide acceptability/feasibility data and obtain effect size estimates of the intervention's strength in changing a desired outcome is conducted in Stage 1b. If Stage 1b results are "promising," the intervention moves to full scale efficacy testing in Stage 2 using the classic experimental design of a randomized control trial (RCT). The intervention is ready for Stage 3 effectiveness testing only after its efficacy has been demonstrated in at least two Stage 2 trials.

Eligibility Criteria:
Inclusion Criteria:

To be eligible, participants must:

1. be male;
2. self-identify as Hispanic/Latino;
3. be 18 - 29 years of age;
4. live in South Florida;
5. have had at least 1 episode of unprotected anal sex with a man in the last 6 months;
6. have had at least 2 male sex partners in the last 6 months;
7. be HIV negative or not known to be HIV positive; and
8. have not previously participated in this study.

Exclusion Criteria:

1. living with HIV infection
A Brief Affirmation Intervention on HIV-related Distress and Positive Living in Lesotho

This study is interested in the stress associated with being HIV positive and looking at ways to reduce that stress. Individuals who are HIV positive face a number of nontrivial threats and stressors: the burden of illness, loss of work, stigmatization, and the chance of death. The study investigates the use of self-affirmation to reduce some of these threats and stressors. Self-affirmation may helping people to cope with these threats and stressors by reminding individuals of other valued aspects of themselves, thus reducing the impact, both psychologically and physiologically, of these threats. Experimentally induced affirmations in which individuals are asked to write about values that are important to the self have been shown to reduce physiological stress among healthy student populations (Sherman, Bunyan, Creswell, \& Jaremka, 2009).

This research will be conducted in collaboration with the global health organizations, PSI who is already providing counseling to those living with HIV on how to reduce the spread of HIV and how to live a healthy life with HIV. These counseling sessions take place at local clinics and hospitals while individuals are waiting to be seen for treatment and are completely voluntary.


Eligibility Criteria:
Inclusion Criteria:

* HIV+
* A CD4 count of less than or equal to 500 cells/mm3 or have significant symptomatology and HIV co-illness (WHO HIV clinical stage 3 or 4) to be eligible to start antiretroviral therapy

Exclusion Criteria:

-
Assessment and Prevention of Caregiver Burden in Oncology

The goal of this randomized, open and controlled supportive care study is to see if we can reduce the burden on the caregiver by offering the caregiver systematic and regular support from the nurse (APN, nurse coordinator in French health care organisations) compared to a support focused on the patient. At the same time, we will also evaluate the impact of this personalised support for the caregiver on their anxiety and quality of life.

Participants will caregivers of a patient who started a line (any line) of systemic treatment for a solid tumour since less than 3 months or in an active palliative situation since less than 1 month.

Researchers will compare 2 groups : a group where caregivers benefit from specific nursing support and a group of caregivers with no specific nursing support.

The specific support includes 3 mandatory on-site nursing consultations with the patient's caregiver and interviews once a month with a nurse either by phone, on-site consultation or teleconsultation.


Eligibility Criteria:
Inclusion Criteria:

* Caregiver designated by the patient;
* Caregiver of a patient who started a line (any line) of systemic treatment for a solid tumour since less than 3 months or in an active palliative situation since less than 1 month;
* Caregiver of patient already cared for by a nurse before inclusion or going to start a nursing follow-up;
* Caregiver of a patient with a score ≥2 of social fragility and/or psychological fragility and/or nutritional fragility and/or complexity;

Exclusion Criteria:

* Patient whose life expectancy is assumed to be \< 6 months;
* Patient living in an institution (EHPAD, MAS, SSR, MCO, USLD) at inclusion;
* Caregiver declared as having a pathology that could alter his/her capacity to support (psychiatric history, dementia...) or under guardianship.
Oncoliq: Early Breast Cancer Detection Based on Liquid Biopsies and microRNAs

Oncoliq is a novel early breast cancer detection test based on liquid biopsies and microRNAs. This innovative test aims to improve the accuracy of cancer detection, thereby reducing patient mortality and healthcare costs.

To develop this test, the discovery and validation phases have been completed. In addition, Machine learning and AI were used to determine the algorithm for breast cancer detection.

The overall objective of this protocol is to implement a pilot test to enroll 1,000 women without a previous cancer diagnosis who are attending their annual medical check-up.

To achieve this, we will develop the following specific objectives:

Enroll women over age 35 who attend the gynecological annual check-up. Test the plasma of the enrolled volunteers for specific miRNA biomarkers using RT-qPCR.

Perform an analysis based on artificial intelligence techniques in collaboration with IMAGO Systems (USA) on mammogram images.

Compare the results obtained from the clinical check-up (BiRad from mammogram), IMAGO Systems and RT-qPCR (Oncoliq breast test). Conduct a 5-year follow-up on volunteers with pathological results from Oncoliq breast test.

Participants who meet the inclusion and exclusion criteria and agree to take part in the protocol will be required to sign both pages of the Informed Consent Form and complete the Annex and Survey. Subsequently, a small blood sample of 3-5 mL will be drawn via venipuncture.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 35 years old who visit the gynecological clinic for their annual mammographic check-up

Exclusion Criteria:

* Personal history of cancer