cyrilzakka/clinical-trials huggingface dataset:
Erlotinib for Treatment of Psoriasis

The purpose of this study is to determine whether erlotinib is effective in the treatment of psoriasis.

Psoriasis vulgaris is a disease that affects 25 million people in North America and Europe. It often presents in late adolescence and usually persists for life. Current therapies target specific immune molecules that are implicated in the cause of this disease. For example, biologic agents that are used in severe psoriasis are aimed at inflammatory mediators. These therapies have been proven to be effective but also have their limitations.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of moderate to severe psoriasis
* Must have documented moderate to severe psoriasis by the Physician's Global Assessment (PGA) and the Psoriasis Area Severity Index (PASI)
* Must be able to swallow tablets
* Must be able to provide written informed consent
* Subjects with reproductive potential (menopausal for less than 1 year and not surgically sterilized) must practice effective contraceptive measures throughout the study and thirty days after discontinuation of study drug. Women of childbearing potential must provide negative pregnancy test (serum or urine) within 14 days prior to randomization.

Exclusion Criteria:

* Use of concurrent agents/therapies for psoriasis
* Bilirubin \> 3 X ≥ ULN or moderate to severe hepatic impairment
* Pregnant or breast-feeding females
* Subjects currently receiving other anticancer treatments
* Subjects currently receiving other biologic treatments
* Subjects currently receiving blood thinners (warfarin or heparin)
* Subjects who currently smoke
* Subjects with other skin disease which in the opinion of the investigator, would inhibit the ability to use the PGA and PASI evaluation methods
Impact of an Intervention Program on Parenting Stress After Preterm Birth

The aim of this study was to assess the impact of an early psychological intervention, Triadic parent-infant Relationship Therapy (TRT), on parenting stress, parental mental health, and preterm infant development in the motor, cognitive, emotional and behavioral domains at a corrected age of 18 months.

Due to prematurity induced infant-mother separation at birth, sometimes for several weeks, and owing to the concerns it generates, preterm birth exposes the parent-child attachment link to disturbances, especially the mother-child attachment after discharge. Several psychological factors affect infant (distress, dysmaturity ) and parents (psychological pain). These can cause lasting parent-child interactions disruption and jeopardize the attachment process. These early link distortions may hinder the infant's behavioral-emotional and cognitive development. Prematurity psychological consequences may negatively influence biomedical risks. Understanding these premature infants' future development modalities and support involves taking into account intricate organic and psychological factors - which may be combined as well.

Post-hospital psychological intervention with the family, focusing on parental mental health and triadic parent-infant relationship, proves an essential element in these children care, whose birth conditions were painful.

Eligibility Criteria:
Inclusion Criteria:

* Enrolled preterm infant were required to be between 28 and 35 weeks gestational age +6 days
* Enrolled the parents were required to be French speakers, over 18 years old and residing within 50-kilometres radius of hospital

Exclusion Criteria:

* preterm infant without congenital anomalies or any other foreseeable disabilities during the neonatal period
* parents without known psychiatric history
The Efficacy and Safety of a Single 70% Glycolic Acid Peel With Vitamin C for the Treatment of Acne Scars

Our study involves the evaluation of a high potency chemical peel in its efficacy and safety profile for the treatment of acne scars. This chemical peel regime is a high potency peel of 70% glycolic acid combined with vitamin C that is purported to provide a good balance between yielding results and patient safety. We aim to evaluate its efficacy and safety profile of a single application. The study design is based on a single group that compares pre- vs post-intervention. 10 patients with atrophic acne scars of skin type I-IV will be recruited. Potential benefits include improvement of post acne scars with a short downtime and risks include post peel hyper pigmentation and scarring. We believe that this treatment will be highly beneficial to patients with post acne scarring.

This chemical peel regime has good efficacy and safety profile for the treatment of acne scars.

Primary endpoints:

1. ECCA (échelle d'évaluation clinique des cicatrices d'acné) grading scale for quantitative grading of acne scars. Two blinded evaluators compare and rate the photograph using ECCA score.
2. Patient Assessment Based on 1 to 10 point scale; 1- nil acne scars and 10- severe acne scar

Secondary endpoints:

1. Postacne hyperpigmentation index (PAHPI)

   -Each of these 3 variables --size, intensity, and number of lesions is weighted and the summation of the weighted variables gives the total PAHPI score, ranging 6 to 22.
2. Safety Assessment (This is an ordinal scale) i. Score of redness ii. Score of swelling iii. Score of oozing/crusting iv. Post peel hyperpigmentation v. Post peel scarring vi. Assessment based on patient and doctor global assessment (global assessment from 1 - 10)

Eligibility Criteria:
Inclusion Criteria:

1. Atrophic scars
2. Skin type I to IV

Exclusion Criteria:

1. Pregnancy, breastfeeding
2. Active dermatitis (on the face), rosacea, allergic rhinitis, active herpes simplex
3. Known hypersensitivity
4. Previous keloids
5. Laser ablative procedures within the last month
6. Chemical peels within the last 6 months
7. Used oral retinoids in the past 6 months
8. Used topical retinoids in the past one week
9. Used scrub, AHA, skin irritant for the past 24h
10. Presence of facial warts or fungal infections
11. Photoallergies
12. Prior poor reaction to a chemical peel
13. Radiotherapy
14. Skin type V and VI
15. Patients with predominantly ice pick and boxcar scars
HD Sense Pilot Study - a Novel Method of Hemodynamic Monitoring

Measurement of arterial blood pressure is a basic monitoring in the perioperative setting. It is a standard monitoring to assure an adequate cerebral perfusion pressure and is a basic parameter of hemodynamic optimization. Until now standard methods for blood pressure measurement are non-invasive interval monitoring by arm cuff (Riva-Rocci) or direct, continuous and invasive by inserting an intraarterial catheter. This observational study will show, that a new non-invasive piezocapacitative-interlayer technology will make continuous blood pressure monitoring and non-invasive pulse contour analysis available.

Measurement of arterial blood pressure is a basic monitoring in the perioperative setting. It is a standard monitoring to assure an adequate cerebral perfusion pressure and is a basic parameter of hemodynamic optimization. Until now standard methods for blood pressure measurement are non-invasive interval monitoring by arm cuff (Riva-Rocci) or direct, continuous and invasive by inserting an intraarterial catheter. This observational study will show, that a new non-invasive piezocapacitative-interlayer technology will make continuous blood pressure monitoring and non-invasive pulse contour analysis available. For this reason all patients will get a basic monitoring (NIBP, ECG, SpO2)

Eligibility Criteria:
Inclusion Criteria:

* elective surgery and general anesthesia
* age \>/= 18 years
* any surgery in ENT/trauma/gynecology/visceral surgery/thoracic surgery/urology/neuro surgery/cardio surgery (N=10)
* cardio surgery (N=10)
* Transcatheter Aortic Valve Implantation (N=20)
* cystectomy (N=10)
* neurosurgery with an expected postoperative ICU stay \>/= 20 hours (N=10)

Exclusion Criteria:

* pregnant or breastfeeding patients
* emergency surgery
* participation in a clinical interventional study
* BMI \>35 kg/m²
* impossibility to place the ConCardiac interlayer
* difference of blood pressure of right and left arm \> 12 mmHg
* pAVK Fontaine IV
* arrythmia absoluta
* vitium cordis \>/=3
* ejection fraction \<35%
* TAPSE \</=16mm
* need of IABP
Radiomics Model Based on DCE-MRI and Ultrasound Images for Breast Lesion Classification

To develop and compare multi-modality radiomics models based on DCE-MRI, B-mode ultrasound (BMUS) and strain elastography (SE) images for classifying benign and malignant breast lesions.

In this retrospective study,555 breast lesions from 555 patients who underwent DCE-MRI, BMUS and SE examinations were randomly divided into training (n =388) and testing (n = 167) datasets. Radiomics features were extracted from manually contoured images. The inter-class correlation coefficient (ICC), Mann-Whitney U test and the least absolute shrinkage and selection operator (LASSO) regression was applied for feature selection and radiomics signature building.Nine radiomics models including four single-modality radiomics models (DCE-3D, DCE-2D, BMUS, and SE), four multi-modality radiomics models (BMUS + SE, DCE-3D + BMUS, DCE-3D + SE, and DCE-3D+SE+BMUS), and the combination diagnostic model(clinical features and DCE-3D+SE+BMUS features) were developed and evaluated by their discrimination, calibration, and clinical usefulness.

Eligibility Criteria:
Inclusion Criteria:

Patients with breast lesions underwent biopsy or surgical resection between January 1, 2018 and March 30, 2024.

Exclusion Criteria:

1. pathologicalresult of biopsy or surgical specimen was unavailable for the target lesion;
2. patients without DCE-MRI, BMUS and SE examinations before biopsy or surgery within one month;
3. patients hadperformed radiotherapy, chemotherapy, or breast biopsy before MRI and ultrasound examinations;
4. patients without completeDICOM data for each examination;
5. patients with poor-qualityimages.
Study Evaluating the Efficacy of Niraparib and Dostarlimab (TSR-042) in Recurrent/Metastatic HNSCC

The purpose of this study is to determine the best overall response of the combination of dostarlimab and niraparib in patients with recurrent and/or metastatic HNSCC patients.

Recurrent and/or metastatic HNSCC patients will be treated with combination of the PD-1 inhibitor (dostarlimab) and PARPi (niraparib) concurrently and ORR, PFS and OS will be determined.

Eligibility Criteria:
Inclusion Criteria:

* Histologically, cytologically, or radiographically confirmed recurrent or metastatic non cutaneous HNSCC for which there are no surgical or radiation curative options.
* ECOG performance status ≤2
* Patients must be able to swallow pills

Exclusion Criteria:

* Nasopharyngeal and salivary gland tumors
* Patients who have not recovered from adverse events due to prior anti-cancer therapy with the exception of alopecia
* Prior exposure to both immunotherapy drugs (PD-1, PDL-1, CTLA-4 inhibitors) and PARP inhibitors. Single exposure to either immunotherapy or PARP inhibitors is allowable.
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to niraparib or dostarlimab.
* Patients with uncontrolled intercurrent illness.
* Requirement of any use of steroids greater than the equivalent of 10mg prednisone daily is not allowed.
A Study to Assess the Safety, Tolerability, Efficacy, and Drug Levels of BMS-986369 (Golcadomide) in Participants With Relapsed or Refractory T-cell Lymphomas in Japan (GOLSEEK-3)

The purpose of this study is to test the safety, tolerability, efficacy, and drug levels of BMS-986369 (Golcadomide) in participants with relapsed or refractory T-cell lymphomas in Japan (GOLSEEK-3).


Eligibility Criteria:
Inclusion Criteria

- Have one of the following subtypes of T-cell Lymphoma (TCL) with relapsed or refractory disease, as assessed by the investigator:.

i) Adult T-cell leukemia-lymphoma (ATL).

ii) Peripheral T-cell lymphoma not otherwise specified (PTCL-NOS).

iii) Angioimmunoblastic T-cell lymphoma (AITL) and other nodal lymphomas of T follicular helper phenotype (TFH) cell origin.

iv) Anaplastic large cell lymphoma (ALCL), anaplastic lymphoma kinase-positive (ALK+).

v) ALCL, anaplastic lymphoma kinase-negative (ALK-).

vi) Breast implant-associated ALCL.

vii) Extranodal NK/T-cell lymphoma, nasal type (ENKL).

viii) Mycosis fungoides (MF) with advanced stage (stage IIB-IVB).

* Phase 1 participants must not be responsive, intolerant, or ineligible to standard therapies that may prolong life or provide symptomatic relief, or for whom no standard therapeutic option is available in the clinical practice guidelines in the opinion of the investigator.
* Phase 2 participants must have been treated by at least 1 prior line of systemic therapy.
* Have an Eastern Cooperative Oncology Group performance status of 0, 1 or 2.

Exclusion Criteria

* Have any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the participants from participating in the study.
* Have any condition, including active or uncontrolled infection, or the presence of laboratory abnormalities, which places the participants at unacceptable risk if he/she were to participate in the study.
* Have a life expectancy ≤ 3 months.
* Other protocol-defined Inclusion/Exclusion criteria apply.
IGHID 12219 - A Brief Alcohol Intervention for PrEP Use Among MSM in Vietnam

The purpose of this study is to evaluate the effectiveness of a brief alcohol intervention (BAI) vs. standard of care (SOC) to improve pre-exposure prophylaxis (PrEP) use among men who have sex with men (MSM) with unhealthy alcohol use initiating or re-initiating PrEP in Vietnam.

This is a two-arm effectiveness randomized controlled trial (RCT) to compare the brief alcohol intervention (BAI) to the standard of care (SOC) among MSM with unhealthy alcohol use who are initiating or reinitiating oral, event-driven, or injectable PrEP in Vietnam.

The BAI draws from Motivational Interviewing (MI)/Motivational Enhancement Therapy (MET) and Cognitive Behavioral Therapy (CBT) and includes 2 in-person sessions and 2 telephone sessions.

Eligible participants (n=564) will be randomized 1:1 to each arm (282 per arm). Additional assessments among a subset of participants in the BAI arm will assess acceptability of the intervention (n=48) Study activities will span 5 years. Individual MSM participants will be followed-up for 12 months with assessment visits at 3, 6, 9, and 12 months after enrollment.

Eligibility Criteria:
Inclusion Criteria:

* Newly initiating PrEP or re-initiating PrEP after at least 3 months from a missed PrEP appointment, based on Vietnamese PrEP guidelines
* Assigned male sex at birth
* Identify as male
* Receptive or penetrative anal intercourse with a man in the past 6 months
* AUDIT-C score ≥ 4 (unhealthy alcohol use)
* 16 years of age or older
* Intention to receive PrEP care in Hanoi for 12 months
* Willingness to provide informed consent

Exclusion Criteria:

* Psychological disturbance, cognitive impairment, or threatening behavior
* Unwilling to provide locator information
* Current participation in alcohol programs or studies
* Current participation in other research studies (including HIV and PrEP studies)
* Ever enrolled in an HIV vaccine study
* Clinical Institute Withdrawal Assessment of Alcohol Scale (CIWA) ≥ 10, indicating risk for alcohol withdrawal
CORTERAS STUDY: The Effect of Corticosteroids on Early Recovery After Major Surgery in Elderly Patients

Major surgery induces a systemic inflammatory response, which can influence the post-operative morbidity, such as coagulation disorders and post-operative muscle weakness, hampering early recovery after surgery.

Single administration of high dose corticosteroids is known to reduce this inflammatory response and could possibly improve the post-operative outcome.

The CORTERAS study will evaluate the effect of administration of corticosteroids, as compared to no corticosteroids, on postoperative muscle weakness and quality of recovery after surgery in elderly patients.

The number of elderly patients undergoing surgery is expected to increase in the coming years, due to the increase in life expectancy in the developing world. Compared to younger surgical patients, the older patients are at greater risk of mortality and morbidity after surgery.

Post-operative fatigue is an important complication after surgery. Not only is it reported by patients as one of the most distressing symptoms, it is also thought to be a significant contributor to delayed recovery after surgery. From a pathophysiological point of view, muscle weakness could be a major contributor to this post-operative fatigue.

Recent studies showed a profound reduction in muscle strength after surgery in elderly patients, which lasted for more than 3 months after surgery. This decrease in muscle strength might be induced by an excessive inflammatory response to surgery.

Glucocorticosteroids are capable of tampering an excessive inflammatory response to surgery and could improve the quality of recovery after surgery. However, a possible effect on post-operative muscle weakness hasn't been specifically investigated.

Therefore, the main objective of this prospective clinical trial is to evaluate the effect of corticosteroids on early post-operative outcome, focusing on muscle weakness, in elderly patients (≥60 years) undergoing surgery.

Eligibility Criteria:
Inclusion Criteria:

* Aged 60 years or older.
* Scheduled for one of the predefined surgical procedures:

  * off-pump coronary bypass surgery
  * on-pump coronary bypass surgery
  * aortic and mitral valve replacement
  * laparoscopic hemicolectomies
  * thoracoscopic lung resections
  * femoral popliteal and tibial bypass surgery and femoral profundoplasty
  * laparoscopic radical prostatectomies

Exclusion Criteria:

* Lack of informed consent or inability to give informed consent.
* Severe postoperative nausea \& vomiting (PONV), needing corticosteroids as PONV prophylaxis.
* Urgent, not elective surgery
* Hypersensitivity or known allergic reactions to methylprednisolone
* Preoperative systemic use of steroids:

  * Including, but not limited to, the use of corticosteroids \> 4 weeks before surgery of at least 4 mg methylprednisolone equivalents.
  * Excluding inhalational and topical steroids
* Preexisting muscle disease o Including, but not limited to: Steinert's disease, amyotrophic lateral sclerosis (ALS), Duchenne dystrophy, amputation of dominant arm or hand.
Efficacy and Safety of Acetaminophen and Aspirin Versus Placebo in the Acute Treatment of Migraine

The purpose of the study is to evaluate the efficacy and safety of acetaminophen and aspirin versus placebo in the acute treatment of migraine


Eligibility Criteria:
Inclusion criteria:

1. Male or female aged 18 years and over.
2. International Headache Society (IHS) diagnosis of migraine without aura or typical aura with migraine headache.
3. History of experiencing at least 1, but not more than 8, acute migraine attacks monthly during the previous year.
4. History of at least moderate migraine pain intensity, if left untreated.
5. History of frequently or always experiencing nausea with the migraine attack.

Exclusion criteria:

Subjects eligible for inclusion in this study must not fulfill any of the following criteria:

1. Headache symptoms which may be due to or aggravated by:

   * Recent (within 6 months) head or neck trauma (e.g., whiplash)
   * Head or neck pain secondary to an orthopedic abnormality
   * Cluster headache
   * Specific migraine variants (e.g., basilar-type artery migraine, opthalmoplegic migraine, hemiplegic migraine, migraine aura without headache)
   * Other serious, non-migraine causes of headache (e.g., increased intracranial pressure, intracranial bleeding, meningitis, malignancy)
   * Non-serious, non-migraine causes of headache (e.g., cold, flu, hangover)
2. History of vomiting during more than 20% of migraine attacks.

Other protocol-defined inclusion/exclusion criteria may apply
the Correlation Between Non-invasive Indicators in Patients With Biliary Atresia

we propose this study and try to find out possible clinical applicable non-invasive imaging indices or its combination with the laboratory indices to predict the status of hepatic fibrosis in BA patients.


Eligibility Criteria:
Inclusion Criteria:

* pathological proved diagnosis of biliary atresia, and without other distinct abnormality or malformations. All had undergone Kasai portoenterostomy. All of them received abdominal MRI study.

Exclusion Criteria:

* absence of laboratory data required.
Cardiac Sarcoidosis Response To Steroids Trial

There are no published clinical consensus guidelines on the treatment of cardiac sarcoidosis. Corticosteroid therapy is advocated by some experts, but is based on small observational studies, with varied clinical response.

Objectives of this trial:

* to systemically assess the response of patients with cardiac sarcoidosis, to treatment with corticosteroids
* to identify the clinical predictors of response to treatment with corticosteroids
* to assess the utility of imaging with PET and MRI to predict response to treatment with corticosteroids
* to determine the prevalence of cardiac sarcoidosis in young patients with unexplained heart block and in patients with unexplained dilated cardiomyopathy associated with ventricular tachycardia
* to use the data from this pilot study to assess the need, feasibility, and sample size for a larger multicentre trial


Eligibility Criteria:
Inclusion Criteria:

* evidence of clinical cardiac sarcoidosis causing significant conduction system disease (defined as complete right bundle branch block and left axis deviation or left bundle branch block or second or third degree AV block in young patients (\< 60 yrs) AND/OR
* evidence of clinical cardiac sarcoidosis causing non-ischemic dilated cardiomyopathy and sustained ventricular tachycardia AND
* PET or MRI imaging supporting the diagnosis of cardiac sarcoidosis

Exclusion Criteria:

* unable or unwilling to provide informed consent
* history of noncompliance of medical therapy
* patients with active infection
* patients with active inflammatory disease not related to sarcoidosis
* patients with other known causes of heart block or LV dysfunction
* patients with known active malignancy
* patients wwho are pregnant or lactating
* patients with other indications for steroids
Evaluate Safety and Efficacy of an Oral Contraceptive (OC) Preparation Versus Placebo for 6 Treatment Cycles in Women With Moderate Acne

The objectives of this study were to evaluate the efficacy and safety of drospirenone 3 mg/ethinyl estradiol 0.02 mg (DRSP/EE) in comparison with placebo in female subjects with moderate acne vulgaris during 6 treatment cycles


Eligibility Criteria:
Inclusion Criteria:

* Female age 14-45, with 10 to 100 comedones (noninflammatory lesions), 10 to 50 inflammatory lesions (papules or pustules), and not more than 35 nodules (\<5mm) on the face).

Exclusion Criteria:

* Standard contraindications for use of combined oral contraceptives (class label)plus
* Subjects with acne and atopia, comedonal acne or acne conglobate, sandpaper acne or acne with multiple large nodes, cysts, fistular comedones, or abscessing fistular ducts
* Use of comedogenic covering cream, comedogenic sunscreens, other sex hormone preparations or any other anti-acne therapy (eg, light therapy, oleic acids, chemical peelings, mechanical extraction of comedones)
* Acne therapy with sex hormone preparations given over 3 months or longer and proved to be unsuccessful
* Preparations that have had an acne-inducing effect, eg, iodinated or bromated drugs, tuberculostatics, lithium, Vitamin B1, B6, B12, D3, corticoids, ACTH, anabolics, quinine, disulfiram, methoxypsoralen, phenobarbital, phenytoin, trimethadione, thyroid depressants, and certain oily cosmetics