cyrilzakka/clinical-trials huggingface dataset:
Study of Trifarotene Cream to Assess Risk of a Trophic Acne Scar Formation

The purpose of this study is to evaluate the safety and efficacy of trifarotene 50 microgram per gram (mcg/g) cream compared to its vehicle on the risk of formation of atrophic acne scars after 24 weeks of treatment in facial acne participants assessed by atrophic acne scars count.


Eligibility Criteria:
Key Inclusion Criteria:

* Participant with clinical diagnosis of acne vulgaris on the face as defined by (excluding the nose and middle zone of approximately 2 centimeter \[cm\]):

  1. Investigator's Global Assessment (IGA) score of 3 (Moderate) or 4 (Severe), with the same score on both sides of the face; and
  2. A minimum of 20 inflammatory lesions (papules and pustules) in total with at least 10 on each side; and
  3. No more than 2 nodules (greater than or equal to \[\>=\] 1 cm in diameter) on the face; and
  4. A minimum of 10 atrophic acne scars in total (\>2 mm)
* Participant with a symmetrical number of the following lesions/scars on the whole face:

  1. Inflammatory and non-inflammatory lesions; and
  2. Atrophic acne scars (minimum of 4 scars per half-face)
* The participant is a female of non-childbearing potential
* If a female of childbearing, potential uses oral contraceptives that are also approve for treating acne vulgaris
* Other protocol defined inclusion criteria could apply

Key Exclusion Criteria:

* Participant with acne conglobata, acne fulminans, secondary acne, nodulocystic acne and acne requiring systemic treatment
* Participant with any acne cyst on the face or with more than 3 excoriated acne lesions
* Participant with known active or chronic allergies or suspected allergy to trifarotene or excipients of the formulation
* Participant with facial dermal conditions (for example, tattoo, skin abrasion, eczema, sunburned skin, scars, nevi, etc.) that may interfere with study assessments in the opinion of the investigator
* Participant with known impaired hepatic or renal functions, based on medical history
Can Oxytocin Level Predict Postpartum Depression?

The goal of this research study is to understand the relationship between the hormone oxytocin and postpartum mood.

Postpartum depression (PPD) affects some one in five new mothers, and adversely influences maternal adaptation to motherhood. While it is known that women with a prior history of depression, or depression during pregnancy, are at elevated risk for postpartum depression, many women with no prior history of depression or other risk factors go on to develop depression in the postpartum period. Considering the grave consequences of postpartum depression on maternal infant bonding and childhood psychological development, it is critical to develop reliable methods to identify which women, who are not depressed during pregnancy, will become depressed after delivery.

The biological pathways leading to depression at any time in life, including around pregnancy, are still poorly characterized. Oxytocin (OT), a hormone involved in delivery and lactation, has received recent attention regarding its additional role in maternal emotions and care taking behaviors after birth. The primary goal is explore the relationship between plasma oxytocin and postpartum mood.

Eligibility Criteria:
Inclusion Criteria:

1. At least 18 years of age
2. English-speaking
3. Pregnant (third trimester at time of visit)

Exclusion Criteria:

1. Current active depression or other mental illness at time of study entry in the third trimester (past depression or anxiety is acceptable)
2. Current antidepressant treatment
3. Severe medical complications in current pregnancy (gestational diabetes, hypertension, thyroid disease)
4. Signs of multiple gestation or of fetal malformation in current pregnancy
5. Cigarette smoking beyond 10th week of gestation of current pregnancy
6. Pre-pregnancy BMI \> 32
Predictors Affecting Long-term Use of Solifenacin or Mirabegron in Women With Overactive Bladder Syndrome

A retrospective analysis of medical records at Far Eastern Memorial Hospital from January 2008 to May 2020 about female patients with overactive bladder syndrome, who received Solifenacin or Mirabegron as the initial treatment. Factors affecting persistence of OAB medications will be analyzed.


Eligibility Criteria:
Inclusion Criteria:

* Women with overactive bladder syndrome received solifenacin or mirabegron as the initial treatment

Exclusion Criteria:

* \<20 year-old
Cilnidipine Effect on High Blood Pressure and Cerebral Perfusion in Ischemic Stroke Patients With Hypertension

The purpose of this study is to compare the effect of cilnidipine (a calcium channel blocker) and losartan (an angiotensin II receptor blocker) on cerebral blood flow (CBF) and blood pressure in hypertensive patients with a previous ischemic stroke.

Design: Multi-center, randomized, double-blind, active control, titrated dose, non-inferiority trial

Population Studied: We will prospectively recruit 250 hypertensive patients who had ischemic stroke 2 or more weeks previously and were admitted at 7 centers in the Seoul metropolitan area in South Korea.

Interventions: After a 2-week washout period, all patients will undergo baseline 99mTc-HMPAO single photon emission computed tomography (SPECT), blood pressure evaluation, NIHSS examination, and laboratory test prior to treatment. The patients will be randomized to receive either cilnidipine 10-20mg or losartan 50-100mg once daily for 4 weeks with a target systolic blood pressure of \< 140mmHg and diastolic blood pressure of \< 90mmHg. After 4-week treatment, all patients will receive follow-up SPECT and blood pressure evaluation. For the quantitative CBF analysis, SPECT will be performed with a single machine in one center.

Outcome Measures: Primary outcome measure is the percentile change of global CBF on SPECT between pre- and post-treatments. Secondary outcome measures include the percentile change of regional CBF, the proportion of patients less than 8.6% decrease of global CBF, and the change of NIHSS score.

Eligibility Criteria:
Inclusion Criteria:

* Ischemic stroke patients with hypertension

Exclusion Criteria:

* Cardioembolic stroke patients
* Severe hypertensive patients
* Secondary hypertensive patients
SHARE (Sharing Goals and Preferences) Study

This research study is evaluating the usefulness of a video and questionnaire to help cancer patients think about the goals of their care.

The investigators are conducting a study with patients from Dana Farber Cancer Institute (DFCI) and DFCI-affiliate at St. Elizabeth's Hospital who are being treated for their cancer. The purpose of the study is to test the implementation of a short video, a brief questionnaire, and a wallet card designed to help patients understand and articulate their goals and preferences when making decisions about their cancer treatment and communicate these preferences to their clinicians.

The short video and brief questionnaire were developed to help patients with cancer think about their goals of care and their treatment and information preferences and to prompt discussions with their health care team about these preferences. The wallet card is designed to help patients remember some key questions that may be useful as they make decisions about future treatments

A pilot test will be completed to assess the feasibility and usability of the revised "More Good Days" video, brief questionnaire and wallet card in helping seriously-ill cancer patients think about what a good day means to them and test whether these tools can help patients to identify and communicate their medical treatment preferences and goals with their care team.

Eligibility Criteria:
Inclusion Criteria:

* Patient who are receiving treatment at:

  * DFCI in the thoracic oncology group
  * DFCI-affiliated St. Elizabeth's Hospital and have progressed on 2nd line or later-line systemic therapies (chemotherapy, immunotherapy, biological, or targeted therapies)
* Clinicians' schedules to identify patients with metastatic cancers who are considering or pursuing additional palliative therapy

Exclusion Criteria:

* Patients who are not interested in the study
* Patients of physicians who opt out of participating
* Patients whose physicians did not opt out, but whose physician does not think they are well suited for the study
Study of A-319 in Patients With Relapsed or Refractory B-cell Lymphoma

Title: A Phase I, Single Centre, Open-label, Dose-escalation Study of A-319 in Patients With Relapsed or Refractory B-cell Lymphoma

Protocol Number: SP071744 Study Stage: Phase I Study Number: 1 site Subject Number: up to 54 patients with Relapsed or Refractory B-cell Lymphoma

Eligibility Criteria:
Inclusion Criteria:

* 18-75 years, all genders
* Patients with definite B-cell Lymphoma, includes FL, MZL, MCL, DLBCL.
* Patients With Relapsed or Refractory B-cell Lymphoma
* ECOG ≤ 2
* Lesions are measurable in 21 days before treatment
* Normal bone marrow function
* Normal liver, kidney, lung and heart function
* the Subjects can sign the ICF and obey the protocol, elsewise, his/her guardian should sign
* Life expectancy is at least 3 months

Exclusion Criteria:• Past or present CNS disease

* Associated with lymphoma by the infiltrates of CNS
* A history of autoimmune disease with CNS involvement or autoimmune disease
* Previous history of autoimmune disease or other malignancy
* A history of deep venous thrombosis or pulmonary embolism
* Auto-HSCT was performed within 12 weeks prior to initiation of treatment
* Previous organ transplantation or allogeneic hematopoietic stem cell transplantation
* The Investigator determined that the patients were associated with a disease, medical condition, or social factor that might affect study results or compliance
* Immunosuppressant are being used
* Radiotherapy was given within 6 weeks prior to A-319 treatment
* Chemotherapy, immunotherapy and targeted therapy were received within 4 weeks before A-319 treatment
* Previous CAR-T cell therapy
* Received anti-lymphoma drugs in the first 4 weeks of A-319 treatment
* There was no recovery of toxic effects (CTCAE\> grade 1 adverse events) at the last treatment, except hair loss
* Those who underwent major surgery 28 days before enrollment (excluding lymph node biopsy);Or plan to operate during the study period
* Those who had received active/attenuated live vaccine within 28 days prior to screening
* For pregnant (positive pregnancy test) and lactating women, those of childbearing age who signed the informed consent form and did not agree to use contraception for at least 3 months after the end of the study;Within 7 days prior to the first day of treatment, women of childbearing age require a positive serum pregnancy test (HCG)
* Male patients who signed informed consent forms and did not agree to use contraception for at least 3 months at the end of the study (except surgical sterilization)
* Known allergy to immunoglobulin or research drugs and their excipients
* Patients considered unfit to participate in the study
Phase 1 Trial of Bevacizumab Treatment for Severe Retinopathy of Prematurity

The purpose of this study is to find a dose of intravitreal bevacizumab that is lower than currently used for severe retinopathy of prematurity (ROP), is effective in this study, and can be tested in future larger studies.

Despite promising initial results using empirical doses of bevacizumab based on half the adult dose for treatment of acute severe ROP, little is known about lower doses of bevacizumab for ROP. An increasing number of ophthalmologists are treating premature infants with severe ROP using bevacizumab. Given the potential systemic and ocular adverse effects of intravitreal bevacizumab injections, determining a lower effective dose of bevacizumab is an important next step. The proposed study will test progressively lower doses to find a dose to take forward to a future larger study.

Eligibility Criteria:
Inclusion Criteria:

1. Type 1 ROP; defined as:

   * Zone I, any stage ROP with plus disease, or
   * Zone I, stage 3 ROP without plus disease, or
   * Zone II, stage 2 or 3 ROP with plus disease
2. No previous treatment for ROP in the study eye; no previous bevacizumab treatment in the non-study eye

Exclusion Criteria:

The following exclusions apply to the study eye:

1. Nasolacrimal duct obstruction
2. Major ocular anomalies (e.g., cataract, coloboma)
3. Any opacity that precludes an adequate view of the retina

If purulent ocular discharge is present in either eye, then the infant is ineligible.
Safety and Effectiveness of the Akreos Toric Intraocular Lens.

The purpose of this study is to evaluate the safety and effectiveness of the Akreos Toric IOL following cataract surgery.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must be willing and able to provide written consent on the EC approved Informed Consent form.
* Subjects must require a lens power from 15 to 30 diopters.

Exclusion Criteria:

* Subjects with any anterior segment pathology for which extracapsular phacoemulsification cataract surgery would be contraindicated.
* Subjects with corneal pathology potentially affecting topography.
Preventive Effect of Perinatal Oral Probiotic Supplementation (POPS) on Neonatal Jaundice

This is a randomized double-blind placebo-controlled parallel group superiority clinical trial among 94 pregnant women (47 in each group) to investigate the effect of maternal perinatal probiotic supplementation on neonatal jaundice, breast milk microbiome, maternal stool, and infant fecal microbiome. Vivomixx®-probiotic product will be used as treatment and placebo as a control.

Neonatal jaundice is a yellowish discoloration of the skin and sclera because of over-concentration of circulating unconjugated bilirubin (hyperbilirubinemia) in the body. It can lead the baby to severe complications including death. Intestinal flora modulation by probiotics administration to the mother may tackle this problem. Therefore, investigators designed a randomized double-blind placebo-controlled parallel group superiority clinical trial among 94 pregnant women (47 in each group). Eligible pregnant women will be recruited voluntarily at 28-36 weeks of gestation and allocated randomly to either the probiotic group (Vivomixx®) or placebo group (maltose-containing unit) which are phenotypically similar. Participants will take one sachet of the product per day starting from 36 weeks of gestation until the end of first week of postpartum. Biological samples (maternal stool, breast milk, and neonatal faeces) will be collected at different time points. Additionally, neonatal transcutaneous bilirubin will be measured on the second and seventh day of life using a Drager Meter (a transcutaneous bilirubinometer). The microbial DNA will be extracted from biological samples using commercial kits and metagenomics sequencing will be employed and will be correlated with bilirubin level using appropriate statistical methods. This study will be conducted based on the Helsinki Declaration and International Council for Harmonization Requirements for Pharmaceuticals for Human Use (ICH) Guideline for Good Clinical Practice (GCP) standards. Ethical approval is obtained from the Joint Chinese University of Hong Kong and New Territories East Cluster (CUHK-NTEC) Clinical Research Ethics Committee, Hong Kong with reference number: 2023.100-T. Written informed consent will be obtained from each participant during enrolment.

Eligibility Criteria:
Inclusion Criteria:

* All pregnant women aged 18-45 years old.
* Gestational age of 28-34 weeks
* Normal singleton pregnancy

Exclusion Criteria:

* Foetal abnormality
* Mothers with antibiotic medication during the allocation
* Couples with glucose 6-phosphate dehydrogenase enzyme deficiency
* Couples with known rhesus or haemolytic disease history
* Plan of place of birth at other hospitals other than Prince of Wales Hospital
* known breast disorder or any contraindication for breastfeeding.
Investigation of Core Endurance in Fibromyalgia

The aim of this study is to compare core endurance and balance in patients with Fibromyalgia Syndrome (FMS) with healthy subjects and to evaluate the relationship between core endurance and balance.The study will include 44 FMS patients and 44 age- and sex-matched healthy controls. Demographic data of the participants will be recorded. Then, core endurance will be assessed with McGill core endurance tests, balance will be evaluated with HUR BTG4 Balance Master System and Berg Balance Scale (BBS), and function will be assessed with Fibromyalgia Impact Questionnaire (FIQ).

Fibromyalgia Syndrome (FMS) is defined as a chronic disease with an unclear etiology, which is characterized by widespread musculoskeletal pain, mainly non-inflammatory, in females between 40-60 years of age, accompanied by fatigue, weakness, sleep problems, depression, anxiety and various cognitive and somatic disorders. The etiology and pathophysiology are still unclear. Balance is a key component of activities of daily living such as walking, running and climbing stairs. Maintaining an upright posture is a complex process that involves perceiving and integrating sensory inputs, planning movements, and executing them effectively. It is also defined as the ability to control the center of gravity within the base of support. The aim of this study is to compare core endurance and balance in patients with Fibromyalgia Syndrome (FMS) with healthy subjects and to evaluate the relationship between core endurance and balance.The study will include 44 FMS patients and 44 age- and sex-matched healthy controls. Demographic data of the participants will be recorded. Then, core endurance will be assessed with McGill core endurance tests, balance will be evaluated with HUR BTG4 Balance Master System and Berg Balance Scale (BBS), and function will be assessed with Fibromyalgia Impact Questionnaire (FIQ).

Eligibility Criteria:
Inclusion Criteria:

* Patients who were aged between 18-65 years,
* Patients who got diagnosed with Fibromyalgia Syndrome

Exclusion Criteria:

* Patients who had regular exercise habits, malignancy, pregnancy, incorporation
* Patients who had changes of medical treatment in last 3 months
* Patients who had dysfunction that can prevent physical activity
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Doses of BI 187004 in Patients With Type 2 Diabetes Mellitus

To investigate safety, tolerability, pharmacokinetics and pharmacodynamics of BI 187004 following multiple dose administration over 14 days.


Eligibility Criteria:
Inclusion criteria:

1. Type 2 diabetes mellitus
2. Current treatment with no more than one anti-diabetic drug (except for insulin and GLP-1 analogues)
3. Males or post-menopausal or surgically sterilised females
4. Age from 20 and to 70 years
5. HbA1c less or equal to 8.5%
6. BMI 28-40 kg/m2
7. Subjects must be able to understand an comply with study requirements

Exclusion criteria:

1. Any finding in the medical examination (including BP, PR or ECG) deviating from normal that the investigator considers to be of not acceptable clinical relevance
2. Repeated measurement of systolic blood pressure greater than 160 mm Hg or diastolic blood pressure greater than 95 mm Hg
3. Myocardial infarction, stroke or transient ischemic attack within 6 months prior to informed consent
4. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders besides type 2 diabetes, hyperlipidaemia or medically treated hypertension
5. Surgery of the gastrointestinal tract that might affect absorption and elimination of the study drug
6. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or relevant neurological disorders besides polyneuropathy
7. Chronic or relevant acute infections (e.g. HIV, hepatitis)
Post Traumatic Critical Complications: a Prospective Cohort Study (ATLANREA)

The purpose of this observational epidemiological study is to investigate the management and the complications associated with severe trauma. Data will be analysed to answer pre-defined scientific projects and to improve management of these conditions.

Pseudonymized data will be collected by study coordinators in a secured e-database.

Cross audit will be performed to check data.

Eligibility Criteria:
Inclusion Criteria:

* severe trauma
* and/or traumatic brain injury
* and/or hemorrhage

Exclusion Criteria:

* Consent withdrawal
Efficacy and Safety of APP13007 for Treatment of Inflammation and Pain After Cataract Surgery Including a Corneal Endothelial Cell Sub-study

This Phase 3 study will evaluate APP13007 in comparison to the matching vehicle placebo in a randomized, parallel-group, double-masked fashion. The subjects will have undergone routine cataract surgery on Day 0 of the study and will be assessed the next day (Post-operative Day; POD1) after uncomplicated surgery for eligibility for randomization to study treatment. The study comprises the Main Study and the Endothelial Cell Sub-study.


Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years of age or older expected to undergo unilateral uncomplicated cataract extraction via phacoemulsification and posterior chamber intraocular lens implantation in one eye.
* Have a pin-hole corrected visual acuity without other correction of ≤ 1.3 logarithm of the minimum angle of resolution (logMAR) in the study eye to be operated and contralateral eye as measured using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart at Visit 1.
* Willing and able to comply with study requirements and visit schedule.
* Provide signed and dated informed consent.

Exclusion Criteria:

* Have a known sensitivity or allergy to clobetasol propionate, corticosteroids, or any of the study medication's components including benzalkonium chloride and soybean lecithin or any routine medication required during cataract surgery or for the conduct of study procedures
* Have an ACC count \> 0 or any evidence of intraocular inflammation (e.g., flare) in either eye at the Screening visit
* Have a Grade \> 0 on the Ocular Pain Assessment in either eye at the Screening visit

Note: Other inclusion/exclusion criteria apply.
tDCS and Robotic Therapy in Stroke

After stroke a limited motor recovery in the paretic upper limb accounts for a large proportion of the disabling sequelae. Only about 15% of those with initial complete upper limb paralysis after stroke recover functional use of their impaired arm in daily life.

The aim of this study is to test the effects of tDCS combined with upper extremity robot-assisted therapy on stroke survivors.


Eligibility Criteria:
Inclusion Criteria:

* Males and females subjects. Age \> 18 years.
* Diagnosis of first ischemic stroke
* Impairment of the upper limb
* Trunk control defined in the Trunk-Control Test (TCT), with a score \> 50.

Exclusion Criteria:

* anyone who does not have adequate understanding of verbal or written information in Italian sufficient to complete any test
* Impaired cognitive functioning: score less than 24 on the Mini Mental Status Examination (MMSE)
* contraindications to single-pulse transcranial magnetic stimulation (TMS)(TMS will be used to measure cortical excitability): presence of a history of epilepsy, frequent headaches or neck pain, implantable devices (ventriculoperitoneal shunts, pacemakers, intrathecal pumps, intracranial metal implants)
* Contraindications to tDCS: intracranial metal implants that can be stimulated, incorrectly positioned or over-heated by the electric current
* Neurological or psychiatric pathology
* severe cardio-pulmonary, renal, hepatic diseases
* Pregnancy