cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate the Safety and Efficacy of PAC-14028 Cream in Seborrheic Dermatitis

This study is a Phase II, single center, randomized, double-blind, placebo-controlled study in male and female subjects, aged ≥ 19 years with mild to moderate seborrheic dermatitis of the face. All subjects will receive BID topical applications of PAC-14028 cream or vehicle for up to 4 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients aged between 19 and 65 years old
* Clinical diagnosis of seborrheic dermatitis in the facial area with Erythema severity ≥ 2 and Scaling severity ≥ 2
* IGE (Investigator's Global Evaluation) Score 2 or 3

Exclusion Criteria:

* Patients with psoriasis, atopic dermatitis, facial acne, rosacea or perioral dermatitis
* Patients who have been infected with bacteria, fungi, virus and animal infectious disease on the facial area
* Patients who were administered topical antifungal agents, steroids, retinoids, or calcineurin suppressants for the treatment of seborrheic dermatitis within the last 2 weeks
* Patients who were administered systemic antifungal agents, steroids, retinoids, or immunosuppressants for the treatment of seborrheic dermatitis within the last 4 weeks
* Patients who were administered local antibiotics for the treatment of seborrheic dermatitis within the last 4 weeks
* Pregnant women, breastfeeding women or women of childbearing potential or women who are planning a pregnancy during the study
Measurements of Body Iron Excretion of Healthy Adults

This is an observation study of subjects who previously had iron-55 isotope administered in studies of iron absorption. By determining the retention of the isotope in blood during a 3-year period, body iron excretion can be measured.

One year following initial administration of iron-55 as a part of other related studies, subjects provide blood samples every 6 months for 3 years.

Eligibility Criteria:
Inclusion Criteria:

* Must have taken iron-55 in previous study conducted by USDA Grand Forks Human Nutrition Research Center

Exclusion Criteria:

* None
Side-to-end Anastomosis Versus Colon J Pouch for Reconstruction After Low Anterior Resection for Rectal Cancer (SAVE)

Primary hypothesis: Side-to-end anastomosis is non-inferior to colon J pouch for reconstruction after low anterior resection for rectal cancer in fecal incontinence (Wexner score).

Research questions: Are there differences between side-to-end anastomosis and colon J pouch in

* bowel function (fecal incontinence, frequency of bowel movements, rectal urgency, incomplete evacuation)
* quality of life
* sexual function
* urinary function
* postoperative complications
* operation time/ institutional costs

Experimental intervention: Low anterior resection for rectal cancer \< 12 cm from the anal verge with total mesorectal excision (TME), ligation of the inferior mesenteric artery close to the aorta, mobilization of the splenic flexure, radical lymph node dissection and side-to-end colorectal/ coloanal anastomosis (STE). The blind end of the descending colon (3-5 cm long) is closed with a linear stapler. Stapling of the anastomosis is done by introducing the stapler from the anus by the assistant surgeon while the surgeon is holding the descending colon in the correct position. The anastomosis is performed on the antimesenteric aspect of the descending colon. The length of the blind end is measured and the integrity of the anastomosis is tested intraoperatively. The intended minimal distal clearance margin from the tumor is 2 cm. A protective loop ileostomy will be performed regularly which is intended to be closed 3 months postoperatively.

Control intervention: Low anterior resection for rectal cancer with total mesorectal excision (TME), ligation of the inferior mesenteric artery close to the aorta, mobilization of the splenic flexure, radical lymph node dissection and colon J pouch rectal/colon J pouch anal anastomosis (CJP). The colon J Pouch is formed by the descending colon by stapling with a defined pouch limb length of 5-6 cm, which is measured intraoperatively. The stapling is done by introducing the stapler from the anus by the assistant surgeon while the surgeon is holding the descending colon in the correct position. The integrity of the anastomosis is tested intraoperatively. The intended minimal distal clearance margin from the tumor is 2 cm. A protective loop ileostomy will be performed regularly which is intended to be closed 3 months postoperatively.

Follow-up per patient: 24 months postoperatively

Eligibility Criteria:
Inclusion Criteria:

* patients with histological proven middle to low rectal cancer (\< 12 cm from the anal verge) requiring low anterior resection with TME
* with or without (neo)-adjuvant radiochemotherapy
* age ≥18 years
* normal preoperative sphincter status (Wexner score = 0)

Exclusion Criteria:

* synchronous metastasis
* age \> 80 years
* previous colon resection
* inflammatory bowel disease
* previous pelvic malignant tumor
* no anterior resection/ TME possible
* synchronous other malignant disease
* emergency operation
* local excision by colonoscopy possible
* unability to complete or comprehend the preoperative questionnaire
Belumosudil and Rituximab for Primary Treatment of Chronic Graft-Versus-Host-Disease

This is an open-label, Phase 2 study designed to evaluate the safety and efficacy of belumosudil and rituximab as primary treatment of cGVHD.


Eligibility Criteria:
Inclusion Criteria:

* First episode of systemic immunosuppression-requiring cGVHD, defined as classic cGVHD by the NIH consensus criteria (without features or characteristics of aGVHD)
* Previously untreated, defined by having received \<10 days of corticosteroids or alternative systemic immunosuppressive agent started specifically for a new diagnosis of cGVHD
* KPS \>/= 70%
* Adequate hematologic function independent of platelet transfusion and G-CSF for at least 7 days prior to study entry: ANC \>750 cells/mm3; Platelets \>30,000 cells/mm#

Exclusion Criteria:

* Late persistent or recurrent aGVHD
* Active uncontrolled infection
* History of HIV infection
* Active HBV or HCV infection. Subjects who are positive for hepatitis B core antibody, hepatitis B surface antigen, or hepatitis C antibody must have a negative PCR result before enrollment. Those who are PCR positive will be excluded.
* Calculated CrCl \<30mL/min
* AST and/or ALT \>5x ULN or direct bilirubin \>3x ULN
* Cardiac ejection fraction \<40% or history of uncontrolled cardiac arrhythmias
* Has received more than one allogeneic transplant prior to the occurrence of cGVHD
Molecular Pituitary Imaging Using 18F-FET PET

The goal of this single centre pilot study is to explore whether 18F-fluoro-ethyl-tyrosine PET (FET-PET) yields comparable findings to 11C-methionine PET (Met-PET) for the localisation of pituitary tumours.

Up to 20 patients with pituitary adenomas (PA) who have previously undergone 11C-methionine PET (Met-PET) as part of routine clinical care will undergo 18F-fluoroethyltyrosine PET (FET-PET). Patients with newly diagnosed PA or residual/recurrent pituitary tumours following previous treatment will be eligible for recruitment to the study.

Quantitative and qualitative analyses will be performed to assess whether MET-PET and FET-PET yield comparable findings in patients with newly diagnosed or recurrent PA.

Eligibility Criteria:
Inclusion criteria

* Participant is willing and able to give informed consent for participation in the study
* Male or female, age 18 or above
* Presence of pituitary adenoma suspected on the basis of clinical/biochemical and/or radiological findings
* Previous 11C-Met-PET/CT

Exclusion criteria

* Inability to give informed consent
* Pregnancy or suspected pregnancy
* Inability to lie supine for 30-60 minutes
* Patient body habitus above scanner dimensions
* Known allergy to intravenous radiographic contrast agents
Double-Blind, Parallel, Randomised Study to Investigate the Effect of Oral Probiotics in Infants With Atopic Dermatitis

To study the effect of supplementation of a hydrolyzed formula with probiotic bacteria on clinical and immunological parameters in infants with AD with and without CMA and to compare effectiveness of different strains of probiotics.

* To determine the effect of supplementation of a hydrolyzed formula with probiotic bacteria on clinical and immunological parameters in infants with AD with and without CMA
* To determine the effect of supplementation of a hydrolyzed formula with probiotic bacteria on clinical and immunological reactivity to cow' milk challenge in infants with AD with CMA
* To compare the effectiveness of different strains of probiotic bacteria in improving clinical and immunological outcome in these infants

Eligibility Criteria:
Inclusion Criteria:

* Term infants fulfilling the Hanifin (1989) criteria for atopic dermatitis

  * Suggestive of CMA (one additional symptom)
  * Scorad index (total) \>20 at study entry
  * Below 5 months of age
  * Formula, not breast fed
  * Written informed consent from the parents

Exclusion Criteria:

* • Previous or current use of anti-histamines, oral corticosteroids, probiotics

  * Use of systemic antibiotic or anti-mycotic drugs in the previous 4 weeks
  * Congenital intestinal abnormality (eg. Hirschsprung's disease, intestinal atresia)
  * Other GI disease with intestinal inflammation and/or increased intestinal permeability
  * Skin disorder, not atopic dermatitis
  * Participation in another clinical study
Multiparametric High-resolution Ultrasound of the Breast

Despite advances in mammographic technique, mammography is limited in the detection and diagnosis of breast lesions with respect to sensitivity and specificity. In recent decades, ultrasound has become an essential adjunct to mammography for the further characterization of mammographically detected or palpable lesions or in the diagnosis of patients with dense breasts.

However, in spite of defined morphological criteria for the differentiation of benign from malignant lesions, ultrasound of the breast also shows limitations regarding sensitivity and specificity. On the one hand, benign lesions may have one or more malignant characteristics and thus require a biopsy. On the other hand, malignant lesions can also show benign characteristics and thus make an accurate assessment difficult.

To overcome these limitations, newer sonographic methods have been developed. These include elastography, color and power Doppler imaging, contrast enhanced imaging and 3D sonography.

The application of elastography is based on the fact that cancer has a higher stiffness than healthy breast parenchyma.

In addition, cancers are characterized by neoangiogenesis and thus generally show an increased vascularization in color and power Doppler. The detection of neoangiogenesis can be improved by the application of contrast agents. The latter provides both morphological and functional information about tumors, through the study of the contrast agent kinetics.

Finally, 3D sonography allows for tumors to be examined in a third, coronal plane. This way, the interaction between the tumor and the surrounding healthy tissue can be better appreciated.

The objective of this study is the evaluation of suspicious (classified as BI-RADS 4 and 5) breast lesions by using high-resolution sonography, including elastography, color/power Doppler, contrast agent application and 3D sonography. Both morphological and functional information can thus be obtained. The primary hypothesis of this study is that this multiparametric approach will improve the detection and characterization of breast lesions.


Eligibility Criteria:
Inclusion Criteria:

* Clinical, mammographic, MR-tomographic and/or ultrasonographic verification of a suspicious breast lesion (BIRADS 4 and 5)
* Age \> 18 years
* Written informed consent
* Histopathological verification of the lesions either by core biopsy or by surgical excision

Exclusion Criteria:

* Unstable or non-compliant patients
* Pregnant or lactating patients or patients with suspected pregnancy
* Known contraindication to the intravenous administration of US contrast agents
* Acute or chronic renal insufficiency
* Pre- or post-transplant patients
Trial of Pemetrexed With or Without PF-3512676 in Advanced Non-Small Cell Lung Cancer

To assess the efficacy and safety of PF-3512676 administered in combination with pemetrexed for the treatment of patients with locally advanced or metastatic NSCLC who have failed one prior chemotherapy regimen

PF-3512676 dosing was stopped 21 June 2007 when Pfizer decided to stop the administration of PF-3512676 in all trials which combined PF-3512676 with cytotoxic chemotherapy. The decision was made subsequent to DSMC recommendation to close two phase III randomized trials in non-small cell lung cancer which also combined PF-3512676 with cytotoxic chemotherapy, citing lack of efficacy concerns as the primary reason with safety issues (sepsis, thrombocytopenia) also contributing to the decision. Subjects were allowed to complete standard of care treatment and protocol follow-up. Data collection was completed on 31 January 2008.

Eligibility Criteria:
Inclusion Criteria:

* Locally advanced or metastatic NSCLC
* Measurable disease
* ECOG PS 0 or 1

Exclusion Criteria:

* Known CNS metastasis
* Pre-existing autoimmune or antibody mediated disease
GS 5885 Administered Concomitantly With GS-9451, Tegobuvir and Ribavirin (RBV) in Chronic Genotype 1 Hepatitis C Virus (HCV) Infection

The purpose of this phase 2 study is to determine whether 30 mg or 90 mg of GS-5885 when given with GS-9451, Tegobuvir and Ribavirin (RBV) for 12 or 24 weeks is effective, safe and tolerable in the treatment of Chronic Genotype 1 HCV Infection.


Eligibility Criteria:
Inclusion Criteria:

* Adult subjects 18 to 70 years of age
* Chronic HCV infection for at least 6 months prior to Baseline (Day 1)
* Liver biopsy results (performed no more than 2 years prior to Screening) indicating the absence of cirrhosis
* Monoinfection with HCV genotype 1a or 1b
* HCV treatment-naïve
* Body mass index (BMI) between 18 and 36 kg/m2
* Creatinine clearance ≥ 50 mL/min
* Subject agrees to use highly effective contraception methods if female of childbearing potential or sexually active male.
* Screening laboratory values within defined thresholds

Exclusion Criteria:

* Autoimmune disease
* Decompensated liver disease or cirrhosis
* Poorly controlled diabetes mellitus
* Severe psychiatric illness
* Severe chronic obstructive pulmonary disease (COPD)
* Serological evidence of co-infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or another HCV genotype
* Suspicion of hepatocellular carcinoma or other malignancy (with exception of certain skin cancers)
* History of hemoglobinopathy
* Known retinal disease
* Subjects who are immunosuppressed
* Subjects with known, current use of amphetamines, cocaine, opiates (i.e., morphine, heroin), methadone, or ongoing alcohol abuse
* Subjects must have no history of clinically significant cardiac disease, including a family history of Long QT syndrome, and no relevant electrocardiogram (ECG) abnormalities at screening
Evaluation of the Outcome of COVID-19 Patients Discharged Home on Oxygen Therapy

The René Dubos Hospital in Pontoise has set up a home discharge system for oxygen-requiring patients in collaboration with PRADO, a health insurance organization, or private providers. This organization coordinates the care to be implemented at home based on the city/hospital link. The coordinator of this organization was also in charge of scheduling a follow-up consultation between 7 and 14 days after hospital discharge.

The aim of this study is to evaluate this new organization, both in terms of its impact on patient outcomes (survival and re-hospitalization rates) and on patients' experiences and satisfaction with their care.

The COVID-19 pandemic was responsible for an unprecedented hospital tension with multiple consequences (medical, economic, social...). The first scientific responses were found with unprecedented speed. Very quickly, innovative solutions and a complete reorganization of the health system were necessary to manage this crisis. In order to limit the number of patients hospitalized and/or the length of their hospitalization, most hospitals quickly set up systems to organize the early return of patients to their homes on oxygen. Studies evaluating telemedicine as a tool for monitoring oxygen-requiring patients at home have shown that it is effective and safe for monitoring these patients. Another retrospective study estimated the 30-day rehospitalization rate for patients with SARS-CoV-2 pneumonia after return home on oxygen with telephone monitoring by a nurse to be 8.5% (95% confidence interval, 6.2%-10.7%) and all-cause mortality to be 1.3% (95% confidence interval, 0.6%-2.5%).

The René Dubos Hospital in Pontoise has set up a home discharge system for oxygen-requiring patients in collaboration with PRADO, a health insurance organization, and a private provider. These organizations coordinate the care to be implemented at home based on the city/hospital link (oxygen provider, private nurse for the injection of anticoagulants and sometimes insulin and monitoring of vital parameters). These organizations were also in charge of scheduling a follow-up consultation between 7 and 14 days after hospital discharge, with the attending physician or, failing that, in the infectious diseases department of the Pontoise Hospital.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years of age

  * Patients with virologically proven COVID 19 (positive Polymerase Chain Reaction or antigenic test) or based on clinical and radiological evidence
  * Patients discharged from hospital or from the emergency room on oxygen between 1 and 5L at the time of discharge
  * Organization of discharge by a service provider (PRADO or private)

Exclusion Criteria:

* Patients discharged from the intensive care unit
* Oxygen-requiring patients \> 5 Liters
A Phase III Trial of Anus-preservation in Low Rectal Adenocarcinoma Based on MMR/MSI Status

pMMR/MSS and 32 dMMR/MSI-H patientspatients were planned to be enrolled. Patients with dMMR/MSI-H will be randomly assigned to the immunotherapy arm or short-course radiotherapy sequential immunotherapy arm; pMMR/MSS patients will receive capecitabine-irinotecan based concurrent radiotherapy before being randomly assigned to the XELIRI or FOLFRINOX arm.

The rate of complete response (sustained cCR for ≥ 1 year), long-term prognosis and adverse effects will be analyzed.


Eligibility Criteria:
Inclusion Criteria:

1. pathological confirmed adenocarcinoma；
2. clinical stage T2-4 and/or N+，Not suitable for initial local excision to achieve radical treatment；
3. the distance from anal verge less than ≤ 5cm，or surgical evaluation concludes that direct surgical anal preservation is not possible without distance metastases；
4. age 18-70 years old, female and male；
5. Strong desire for anal preservation and ability to be closely monitored for at least 2 years after chemoradiotherapywith good compliance；
6. without distant metastases；
7. ECOG Performance status 0-1；
8. Detection of UGT1A1\*6 and \*28 gene status (for pMMR patients)；
9. Sufficient bone marrow reserve and physical capacity to receive consolidation chemotherapy after chemoradiotherapy (for pMMR patients)；
10. with good compliance；
11. signed the inform consen.

Exclusion Criteria:

1. pregnant or breastfeeding women；
2. Persons with a history of uncontrolled epilepsy, central nervous system disorders, or psychiatric disorders whose clinical severity, as judged by the investigator, may prevent the signing of informed consent or affect the patient's compliance with oral medications；
3. Difficult to achieve complete remission at the available level of evidence, such as: tumor largest diameter \>10 cm; largest diameter of lateral lymph nodes \>2 cm; baseline CEA \>= 100; biopsy pathology with an indolent cell carcinoma component; tumor of circumferential narrowing type on anal finger examination, with inclusion decided by the judgment of the evaluation team if necessary；
4. Clinically significant (i.e., active) heart disease, such as symptomatic coronary artery disease, New York Heart Association (NYHA) class II or worse congestive heart failure or severe arrhythmias requiring pharmacological intervention, or a history of myocardial infarction within the last 12 months；
5. persons requiring immunosuppressive therapy for organ transplantation；
6. Persons with severe uncontrolled recurrent infections, or other severe uncontrolled concomitant diseases；
7. Subjects with baseline routine blood and biochemical indicators do not meet the following criteria: hemoglobin ≥ 90g/L; absolute neutrophil count (ANC) ≥ 1.5×109/L; platelets ≥ 100×109/L; ALT, AST ≤ 2.5 times the upper limit of normal; ALP ≤ 2.5 times the upper limit of normal; serum total bilirubin \< 1.5 times the upper limit of normal; serum creatinine \< 1 times the upper limit of normal limit; serum albumin ≥30g/L；
8. Known to have dihydropyrimidine dehydrogenase (DPD) deficiency；
9. allergic to any investigational drug component.
The Cognitive Variability in NF1 and TSC Monozygotic Twins

Both Neurofibromatosis type 1 (NF1) and Tuberous Sclerosis Complex (TSC) are highly heterogeneous diseases. Cognitive features seem to vary widely even between family members carrying the same mutation. This phenotypic variability is not well understood, but is generally assumed to be caused by modifier genes which regulate the affected pathways. However, recent studies brought forward an alternative explanation for the phenotypic variability. Post-mortem studies showed that second hit mutations causing loss of the second ('healthy') allele are more widespread than previously believed. These loss of heterozygosity (LOH) mutations cause bi-allelic loss of the disease-linked gene and are known to cause the gross of somatic features in both diseases (like neurofibromas and hamartomas). Hence, it could be the stochastic occurrence of second-hit mutations in the brain are the cause of the variable cognitive phenotypes.

To investigate to what extent these LOH mutations in the brain contribute to the phenotype and to what extent this variation is due to genetic modifiers factors is unknown. The investigators therefore propose to elucidate this variability by comparing the correlation of cognitive features of monozygotic twins with NF1 or TSC to healthy twins in the population. If modifier genes are the cause of the variability of cognitive features in NF1 and TSC the investigators expect that the variability in cognitive tests in monozygotic twins is the same as monozygotic twins in the healthy population. However, if the variability is caused by the occurrence of LOH mutations, the investigators expect to have a lower correlation in our monozygotic patients compared to the healthy twins.


Eligibility Criteria:
Inclusion Criteria:

* The participant is part of a monozygotic twin pair (which is genetically confirmed);
* NF1 or TSC patients with a genetically confirmed diagnosis;
* Oral and written informed consent by participant in case ≥ 18 years of age.
* Oral and written informed consent by both caregivers and assent by participant in case of minor participants.

Exclusion Criteria:

* A potential subject of whom the twin sibling is not willing or able to participate in this study, will be excluded from participation in this study.
* Symptomatic brain pathology.