cyrilzakka/clinical-trials huggingface dataset:
Study of Inactivated, Split-Virion Influenza Vaccine Administered by Intradermal Route Versus Vaxigrip® in Adults

This is a follow-up of a previous dose-ranging study aimed at investigating 2 doses of the trivalent inactivated split virion influenza vaccine when administered by intradermal route with that of the current pharmaceutical presentation administered by intramuscular route.

Primary Objective:

To assess the immunogenicity of two pharmaceutical presentations of the trivalent inactivated split virion influenza vaccine 21 days after a single injection in subjects aged 18 to 57 years.

Secondary Objective:

To evaluate the safety profile during the 21-day period following each vaccination in each study group

This is an open (for the administration route) and double-blind (only for the two dosages administered at year 0 by using the investigational administration route) randomized trial conducted in subjects aged 18 to 60 years. The subjects will receive three vaccine injections at 1-year interval.

Eligibility Criteria:
Inclusion Criteria :

* Subject aged between 18 and 57 years (i.e., less than 60 at the last vaccination)
* For woman of child-bearing potential, negative urine pregnancy test at V#01
* Use of effective contraception prior to and during the trial
* Subject available during the trial period
* Subject able to read and understand the informed consent form
* Informed consent form signed and dated by the subject prior to any protocol-required intervention (and Visit 05 and Visit 07, respectively).

Exclusion Criteria :

* Self-reported allergy to egg proteins, chick proteins, or any of the constituents of the vaccine, in particular, neomycin, formaldehyde, and octoxinol 9
* Acute febrile disease within the 72 hours preceding V#01, or axillary temperature \>37.5°C the day of inclusion, prior to vaccination (\>37.0°C Czech Republic)
* Subject with an aggravation of existing chronic illness (heart disease, respiratory disease, etc.)
* Vaccination against influenza within the 6 months preceding V#01
* Any vaccination within the 28 days preceding V#01 or scheduled between V#01 and V#02
* Breast-feeding
* Immunosuppressive therapy including long term systemic corticotherapy (20 mg/day of prednisolone or equivalent for \>2 weeks) or cancer therapy within the month preceding V#01 or ongoing
* Immunoglobulin injection within the 3 months preceding V#01
* Subject taking part or planned to take part in another clinical trial (3 months before and through the trial duration)
* Subject having received extracted pituitary hormones
* Subjects who participated in the GID01 study (Lithuanian centers)
Randomized Controlled Trial of Routine Screening for IPV

This is a randomized controlled trial with three arms to establish the impact of screening and referral to services for women disclosing exposure to IPV.

Approximately 2675 women\* will be enrolled and randomized to one of 3 arms. In the first arm, participants will be screened, and if disclosing IPV, will receive information on available resources in the community. In arms two and three, participants will not be screened, but one group will receive information on available resources in the community and the other will not. All three groups will be assessed for quality of life (SF-12;standardized and validated scale with 12 questions that measure overall health (1 item), physical functioning (2 items), role limitations due to physical health problems (4 items), bodily pain (1 item), energy/fatigue (1 item), social functioning (1 item), psychological distress (1 item), and well being (1 item) in the past 4 weeks; items are summed to form a physical health composite scale and a mental health composite scale; each scale is standardized to have a mean of 50 and a standard deviation of 10 for the U.S. population with a possible range from 0 to 100; higher scores represent a better health state); disability; and utilization of health care and IPV services at baseline and at a 12 month follow-up. A pilot study, also using a randomized controlled trial design, will establish the feasibility, acceptability, and impact on disclosure rates, use of referral resources, and potential harms of three screening and referral strategies.

\*sample size calculation based n needed to detect a standardized effect size of 0.3 with an α=.05 (1-tailed)and ß=.20 if there's a 20% IPV (+) rate and 30% lost-to-follow-up rate.

Eligibility Criteria:
Inclusion Criteria:

* women attending obstetrics \& gynecology (OB-GYN), family planning, general medicine, family medicine or HIV/Sexually transmitted disease (STD) clinic

Exclusion Criteria:

* non-English speaking other than Spanish speakers
* accompanied by a child \>3 years of age without adequate provision for child care;
* Visually- or hearing-impaired women;
* without access to a telephone;
* Severe Mental impairment
Extracorporal Photopheresis Pilot Study

ECP will be given to the patients \[UVAR®XTS TM Therakos system, Johnson \& Johnson\] according to the following schedule:

Starting at day 21 after transplant, if hematologic recovery allowed it: 2 ECP per week the first 2 weeks, and 1 ECP per week during 1 month.

Total = 8 ECP after transplantation.


Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years and \< or = 65 years with an hematological malignancy indicated for an allogeneic transplantation after reduced intensity conditioning :
* due to the age : for patients between 55 and 65 years.
* or for patients between 18 and 55 years of age presenting a risk of increased toxicity for myeloablative conditioning (cardiac, renal or pulmonary pathology)
* CML and MPS in blastic phase achieving CR,
* MM stage II or III, relapse after autologous transplant, achieving a response ≥ 30% or on first line if high risk,
* NHL in 2nd CR, PR after chemotherapy or autologous transplant, chemo-sensible.
* CLL in 2nd CR, PR after chemotherapy or autologous transplant, chemo-sensible.
* AML in 2nd CR or in first line for high risk criteria, secondary AML. In AML, high risk criteria are defined by : LAM 7, leukocytes\>30000/mm3, cytogenetic abnormalities: t(6,9); 11q23, 17p, 11q, 20q, 21q, -5, del(5q), -7/del7q, del 9q and inv 3q,
* ALL in 2nd CR or in first line for high risk criteria defined by cytogenetic abnormalities: 11q23, t(9,22); t(1,19); t(4,11).
* MDS patients without prior chemotherapy
* HLA identical sibling donor
* Performans status \< or = 2
* Patients member of a social security company

Exclusion Criteria:

* Age \< 18 years or \> 65 years
* Pregnant or lactating females
* Known HIV positivity
* Active infectious hepatitis, type A, B or C
* Performance status \> 2 according to WHO
* Left ventricular ejection fraction \< 40% and Alveolus-capillary diffusion \< 50%
* Uncontrollable hypertension with medical therapy
* Creatinine clearance \< 60 ml/min
* Hypersensitivity or allergy to psoralen (methoxsalen)
* Disease associated with a photosensitivity
* Hypersensitivity or allergy to both heparin and citrate products
* Contra-indication to Busulfan, Fludarabine, SAT or methotrexate
* Hypersensitivity to ciclosporine, mycophenolate mofetil or mycophenolic acid
Second Transplantation for Graft Failure

Graft failure is a lethal complication after allogeneic stem cell transplantation, which often need a salvage transplantation. However, the current outcome of second transplantation for graft failure is far from satisfactory. We performed a prospective single-arm study to investigate the safety and efficacy of a novel regimen.


Eligibility Criteria:
Inclusion Criteria:

* graft failure after first allogeneic stem cell transplantation
* no active infection or GVHD or severe organ dysfunction
* sign written informed consent

Exclusion Criteria:

* active infection, GVHD, organ failure
* expected life \< 28 days
Study of Olmesartan Medoxomil (CS-866) in Patients With Chronic Glomerulonephritis or Diabetic Nephropathy

The treatment period was 16 weeks, the initial dose, 5 mg, was unforcedly titrated to 10 mg, 20 mg and 40 mg after confirming tolerance at weeks 4, 8 and 12. The primary endpoint for efficacy was the change in the urinary protein/creatinine ratio from baseline to the end of treatment. The secondary endpoint was creatinine clearance (Ccr).


Eligibility Criteria:
Inclusion Criteria:

* urinary protein/creatinine ratio in the 0.50 g/g to 3.50 g/g creatinine range
* normal sitting blood pressure values: systolic blood pressure of 100 mmHg or above but below 140 mmHg; diastolic blood pressure of 50 mmHg or above but less than 90 mmHg

Exclusion Criteria:

* treatment with corticosteroids or immunosuppressants
* treatment with antihypertensives (other than ARBs and ACE inhibitors)
* serum potassium level of 5.5 mEq/l or above
* serum creatinine level of 2.0 mg/dl or above
An Open-Label Clinical Study to Evaluate the Efficacy of a Face Cream and Eye Cream

This single-center clinical trial is being conducted to assess the efficacy and tolerability of an anti-aging eye cream and face moisturizer when used over the course of 12 weeks twice-daily by women, 35-65 years, with mild to moderate droopy eyelids, moderate crow's feet wrinkles, and moderate global facial photodamage.

This was an institutional review board (IRB)-approved study. Female subjects, 35-65 years of age, Fitzpatrick skin type I-VI, with mild to moderate droopy eyelids, moderate crow's feet wrinkles, and moderate global photodamage were recruited. Subjects applied a multi-ingredient anti-aging face moisturizer and eye twice-daily for 12 weeks. Subjects were provided with a gentle cleansing lotion and a sunscreen SPF 40+ to be utilized during the course of the study.

Clinical grading of efficacy and tolerability parameters, VISIA-CR imaging, raking light VISIA analysis, skin pH, Tewameter, and pinch recoil measurements were performed at baseline, weeks 4, 8, and 12. Optical coherence tomography (OCT) imaging was performed at baseline and week 12.

A total of 42 subjects completed the study.

Eligibility Criteria:
Inclusion Criteria:

* Women between the ages of 35 and 65 years
* Women with Fitzpatrick skin type I-VI
* Subjects must have mild to droopy eyelids, moderate crow's feet wrinkles, and moderate photodamage
* Subjects must have no known medical conditions that, in the investigator's opinion, may interfere with study participation.
* Subjects must be willing to provide verbal understanding and written informed consent.

Exclusion Criteria:

* Subjects which had a health condition and/or pre-existent dormant dermatological disease on the face
* Subjects that had any invasive or non-invasive skin treatments, or invasive medical procedures three months prior to the study
* Subjects that are unwilling to comply with the protocol
* Female subjects who are pregnant, breast feeding, or planning a pregnancy.
* Subjects who have any dermatological disorder, which in the investigator's opinion, may interfere with the accurate evaluation of the subject's skin, including rosacea, acne, and excessively oily or dry skin.
* Subjects who have demonstrated a previous hypersensitivity reaction to any of the ingredients of the study products.
* Subjects use of any medications that are known to potentially cause changes in the facial skin as determined by the Investigator.
* Subjects who spend excessive time out in the sun.
Estimation of the ED95 of Intrathecal Hyperbaric Prilocaine 2% With Sufentanyl for Scheduled Cesarean Delivery

Hyperbaric bupivacaine 0.5% associated with opioids is the local anesthetic the most commonly used for spinal injection in cesarean section. Nevertheless, its use often results in a long duration of motor nerve block and a haemodynamical instability. Recently developped, the Prilocaine, with its new 2% hyperbaric formulation, seems to offer a good alternative for hyperbaric bupivicaine. A first study has determined the ED95 of hyperbaric prilocaine 2% for intrathecal anesthesia in scheduled cesarean delivery. As opioid adjuvants potentiate the effect of the local anesthetics while decreasing their dose-related side effects, the aim of this study is to determine the ED95 of hyperbaric prilocaine 2% with sufentanyl for scheduled cesarean delivery under spinal anesthesia,by using the Continual Reassessment Method (CRM)


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists physical status (ASA) \< III
* Age 18-40 year
* Body Weight \<100 kg
* Height between 155 and 175 cm
* Gestational age\>37 SA
* Elective cesarean delivery
* Singleton pregnancy
* Non complicated pregnancy
* Signed informed consent obtained prior to any study specific assessments and procedures

Exclusion Criteria:

* Twin pregnancy
* History of 2 cesarean section or more
* Diabetes and gestational diabetes
* Placenta praevia
* Congenital foetal abnormality
* Patient in labour
* Membrane rupture
* Known allergy to local anaesthetics
* Disagreement of the patient
* Pregnancy-induced hypertension
* Pre eclampsia and eclampsia
The Effectiveness of AIFIGA Program on Nursing Home Nursing Staff and Family and Residents'health

This study aims to develop and evaluate the longitudinal effectiveness of the Artificial Intelligence Family Involvement Generative Agent (AIFIGA) program in enhancing the health of nursing staff, family, and residents' health through the use of a sequential, mixed methods research design. The development of a real-time, interactive, and informative AIFIGA program that sparks innovation is necessary to achieve effective communication between families and nursing staff.

In Phase I, lasting 18 months, we will develop the AIFIGA program based on triangulate research design, observation and in-depth interview understanding the daily communication experiences and expectations from both families and nursing staff perception in Nursing Homes(NHs) after COVID-19, as well as our previous years' research results. The training data for AIFIGA will be derived from the collection of communication dialogues in these qualitative data. Furthermore, the intelligence of AIFIGA will be developed using publicly available large language models (LLMs).

In Phase II, spanning the next 18 months, we will evaluate the longitudinal effects of the AIFIGA program on the health of residents, families, and nursing staff, tracking changes over time (baseline, 1 month, 3 months, and 6 months). There will be two groups of participants: (a) an AIFIGA group that receives the AIFIGA program and uses it for 3 months, and (b) a control group that receives only routine care.


Eligibility Criteria:
Inclusion Criteria:

All resident-caregiver pairs meeting the inclusion criteria will be invited to join the study.

1. residents aged ≥ 60 years, resident's family were aged equal or higher than 20 years.
2. both residents and family can communicate in Mandarin or Taiwanese
3. residents have a Mini-Mental State Examination (MMSE) score equal to or higher than 16 for residents with no formal education or higher than 24 for residents with at least a primary school education
4. both residents and family agree to participate
5. the family is a significant member of the resident, such as a caregiver.

For nurses and nursing aides:

1. working in the selected nursing home who agree to participate in our program.
2. aged equal or higher than 20 years.

Exclusion Criteria:

-
Subthalamic Nucleus Stimulation Effect on Gait Symmetry and Freezing of Gait

Impact of unilateral modulation of deep brain stimulation of the subthalamic nucleus on freezing of gait in Parkinson's disease

Unilateral modulation of subthalamic stimulation and its impact on freezing of gait in Parkinson's disease will be studied.

In a cross-over, doubleblind, randomized study, a 30% reduction of stimulation intensity of the less impacted side will be compared with chronic treatment with regard to frequency and duration of freezing of gait episodes.

Eligibility Criteria:
Inclusion Criteria:

Patients affiliated to social security Patient with idiopathic parkinson's disease, with deep brain stimulation since at least one year Freezing of gait Able to give inform consent

Exclusion Criteria:

Patient under guardianship, legal guardianship Psychosis Severe depression Severe cognitive troubles (Mattis \< 130) Other neurologic or medical pathology interfering with gait
Integrated Mental Health Care and Vocational Rehabilitation to Individuals on Sick Leave Due to Stress Disorders

The purpose of this study is to investigate the efficacy of 1) a stepped mental health care (MHC) intervention and 2) an integrated mental health care and vocational rehabilitation (VR) intervention for people on sick leave because of burnout, adjustment disorder and psychological stress in Denmark

Background:

Stress disorders have negative effects on workability and have negative effects on both the individual and society. Psychological stress and burnout is not recognized as psychiatric diagnoses, and thus, the estimated prevalence in healthy and sick-listed people is somewhat insecure in Denmark. Together with other common mental disorders, burnout, adjustment disorder and psychological stress are causes of up 40 % of the sick leave claims in Denmark. There is no clear evidence that mental health care alone will provide sufficient support for vocational recovery for this target group. Integrated vocational and health care services have shown good effects on return to work in other Scandinavian countries.

Objective:

The purpose of the Danish IBBIS study is to investigate the efficacy of 1) a stepped mental health care intervention and 2) an integrated mental health care and vocational rehabilitation intervention for people on sick leave because of burnout, adjustment disorder and psychological stress in Denmark.

Method:

This three-arm, randomized, controlled trial is set up to investigate the effectiveness of the stepped mental health care model and the integrated mental health care and vocational rehabilitation intervention for people on sick leave because of burnout, adjustment disorder and psychological stress in Denmark. 603 patients are recruited from Danish job centers in four municipalities. The primary outcome is return to work at 12 months.

Results/discussion:

This study will contribute with new knowledge on vocational recovery and integrated vocational and health care interventions in a Scandinavian context.

Eligibility Criteria:
Inclusion Criteria:

* Burnout OR adjustment disorder OR psychological stress according to 4DSQ
* On sick leave from work or unemployment and have received sick leave benefit for minimum four weeks OR have started a sick leave benefit case which is estimated to last for minimum eight weeks
* Citizen in one of the following municipalities: Copenhagen City, Gladsaxe Municipality, Lyngby-Taarbæk Municipality or Gentofte Municipality
* Danish-speaking
* Given informed consent

Exclusion Criteria:

* Pregnant
* High degree of suicidal ideation
* Dementia
* Alcohol or substance misuse that hinders the person participating in treatment
* Wish to start or continue psychological therapy
* Need for psychiatric treatment in the secondary psychiatric care system
* Medically unstable to a degree that the patient cannot adhere to treatment
* Participant in the research project Collabri
* Attending stress courses in the stress clinics of Copenhagen City
* Assessed by Jobcentre case managers to be dangerous
Exercise Performance on Ambient Air Vs. Low-Flow Oxygen Therapy with Chronic Lung Diseases

The investigators aim to study the effect of SOT in subjects with chronic lung disease in submaximal exercise.

Participants with lung disease who live in Switzerland will have 6-minute walk distance (6MWD) test with and without SOT at approximately 3l/min via nasal cannula according to a randomized cross-over design.

The trial aims to test that the 6MWD with SOT is non-inferior to a 6MWD in the same participant under ambient air.

Our effect size was estimated with a difference of less or equal to 35m compared under SOT compared to ambient air.

Eligibility Criteria:
Inclusion Criteria:

* Minimum 18 years of age
* Written informed consent
* Patients with diagnosed chronic lung disease
* Former desaturation under exercise defined as Spo2-decrease \>3%- Page 3 of 4
* Treated with a stable drug therapy (with no changes for at least 14 days prior to screening)

Exclusion Criteria:

* Severe hypoxemia needing supplemental oxygen therapy defined as (partial pressure of Oxygen (PaO2) \< 6.9 KiloPascal (kPa)
* Pregnancy
* Unability or contraindications to undergo the investigated intervention
* Unability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc.
An Antibiotic Protocol Guided by a Multimodal Approach in AECOPD With Pneumonia in Intensive Care

Investigators propose to conduct a multicenter, prospective, randomized, controlled, assessing the interests of an antibiotic protocol guided by the combined use of serum procalcitonin (PCT) and a broad-panel respiratory multiplex PCR (mPCR) to reduce duration of antibiotics exposure in patients with chronic obstructive pulmonary disease (COPD) hospitalized in intensive care unit (ICU) with pneumonia. The primary endpoint is the number of antibiotic-days for the treatment of pneumonia.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years
* Documented or suspected clinically COPD according to the criteria of GOLD
* Community-acquired pneumonia defined as the presence of a radiological (i.e., chest X-ray or CTscan) infiltrates consistent with an infectious site and associated with one or more of the following items: dyspnea, cough, sputum, fever above 38 ° C, chest pain, localized crackles with or without signs of pleural effusion, higher leukocytosis at 10,000 / mm³ or leukopenia below 4000 / mm³
* Admitted to the hospital for less than 48 hours
* ICU Admission
* Informed Consent signed by the patient or his representative

Exclusion Criteria:

* Patient immunocompromised including congenital immunodeficiency, haematologic malignancy, immunosuppressive drugs (including anticancer chemotherapy and post-transplantation therapies), neutropenia neutrophil count below 500 / mm³ secondary to chemotherapy, corticosteroids greater than 0.5 mg / kg / day for more than 10 days, HIV infection
* Therapeutic limitation Existence
* Minor patient or under guardianship or custody
* Pregnant woman
* Refusal to participate in the study
* The inclusion of the subject in another biomedical research protocol in progress or for less than 30 day
* Patients treated with antibiotics before ICU referral are no excluded.