cyrilzakka/clinical-trials huggingface dataset:
Efficacy Study of Thymosin alpha1 & Pegylated Interferon-alpha2a to Treat Chronic Hepatitis B

The purpose of this study is to determine the optimal treatment duration of antiviral therapy for chronic hepatitis B.

Thymosin alpha1/interferon combination therapy has been known as an effective antiviral therapy for chronic hepatitis B. It is superior to interferon single therapy since the sustained viral response rate of combination therapy used to be about 70% compared with that of single interferon therapy(20%). Until now, the combination therapy including 6-month treatment of thymosin alpha1 has been as effective as 12-month treatment of thymosin alpha1. We hypothesized that thymosin alpha1 is an immune potentiator so, the shorter duration of thymosin alpha1 treatment might be as effective as the prolonged treatment duration.

In detail, we designed to perform this clinical study comparing the combination of pegylated interferon and thymosin alpha1 with pegylated interferon alone. Total treatment duration of both parallel groups will be 12 months, and the combination therapy will be lasted for the first 3 months followed by the next, ongoing pegylated interferon single therapy for 9 months.

Eligibility Criteria:
Inclusion Criteria:

* HBsAg positive and anti-HBs negative for more than 6 months
* HBeAg positive
* HBV DNA titer more than 100,000 IU/mL
* serum ALT more than upper normal limit value, but no more than 10 times upper normal limit value

Exclusion Criteria:

* the history of antiviral therapy for chronic hepatitis B within the recent 6 months
* HAV IgM Ab + and/or HCV Ab + and/or HDV Ab and/or HIV Ab +
* the sign of decompensated liver disease
* the history of hemoglobinopathy, autoimmune hepatitis, alcoholic liver disease
* pregnant or lactating woman
* neutrophil count less than 1,500/mm3 or platelet count less than 90,000/mm3
* serum creatinine more than 1.5 times upper normal limit value
* the sign of alcoholic or drug addiction within the recent 1 year
* the history of psychotic disorder especially like depression
* immunologically mediated disease
* the history of esophageal varix
* the history of severe heart disease or respiratory disease
* the history of severe epilepsy or current use of antiepileptic drug
* the sign of malignancy or suggestive of malignancy or the history of malignancy, the recurrence rate within 2 years of which is more than 20%
* the history of systemic anticancer treatment including radiation therapy or immunotherapy including systemic corticosteroid
* the history of major organ transplantation
* the history of medically uncontrolled thyroid disease
* the history or sign of severe retinopathy
Safety Study of Apixaban in Recent Acute Coronary Syndrome

The purpose of this clinical research study is to determine whether apixaban will be safe in people who have recently had unstable angina or a heart attack.


Eligibility Criteria:
Key Inclusion Criteria:

* Recent (\< = 7 days) Acute Coronary Syndrome (ACS).
* Clinically stable on optimal treatment

Key Exclusion Criteria:

* High bleeding risk.
* Ongoing anticoagulant use.
* Need for chronic (\>3 months) daily nonsteroidal anti-inflammatory drug (NSAID) or chronic high dose acetylsalicylic acid (ASA) use (\>325 mg/day
UWCCC Molecular Tumor Board Registry

This study seeks to evaluate the clinical utility of the Precision Medicine Molecular Tumor Board, and to track patient outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Clinically suspected or histologically confirmed solid or hematological malignancy
* Undergoing genetic testing of tumor
* Ability to understand written informed consent document
* Willingness to sign written informed consent document

Exclusion Criteria:

* Pediatric patients (age\<18 years) will be excluded due to a lack of expertise on the molecular tumor committee
Efficacy and Safety Evaluation Study of Neuramis® Deep Lidocaine in Correction of Nasolabial Fold

The purpose of this study is to compare the efficacy and safety of the study medical device, Neuramis® Deep Lidocaine and the control medical device, Restylane® PERLANE-L in correction of nasolabial folds

This study is a multi-center, double blind, intra-individual controlled, active-controlled clinical trial.

Efficacy and Safety are evaluated at the appointed time at subject visit clinical site after Injecting medical device.

Eligibility Criteria:
Inclusion Criteria:

1. Male and female aged between 30 and 70 years, inclusive
2. Subjects who want improvement of bilateral nasolabial folds that are rated as 3 or 4 points on Wrinkle Severity Rating Scale
3. Subjects with visually symmetrical bilateral nasolabial folds
4. Subjects who consent to abstain from wrinkle improvement treatment in the lower face (below the lower orbital rim) during this trial
5. Subjects who are capable of understanding and following instructions, and participating in the entire course of the trial
6. Subjects who voluntarily decide to participate in this trial and provide written consent in the Informed Consent Form

Exclusion Criteria:

1. Subjects who administered an anticoagulant (except for low-dose aspirin (100mg, up to 300mg/day) or equivalent) within 2 weeks prior to screening
2. Subjects who had face-lift, soft tissue augmentation, medium or deeper peeling, or dermal photo-rejuvenation on the lower face (lower orbital rim) for wrinkle improvement within 6 months prior to screening
3. Subjects who received treatment with calcium hydroxyapatite(CaHA) at the investigational medical device injection site within 1 year from screening
4. Subjects who have implanted a permanent expander prosthesis at the investigational medical device injection site, such as soft-form or silicon
5. Subjects with a scar or skin lesion at the investigational medical device injection site that may interfere with judgment of the treatment effect
6. Subjects with a history of anaphylaxis or severe complicated allergy or allergy to lidocaine or hyaluronic acid products
7. Subjects with a history of a hypertrophic scar or keloid
8. Subjects with a skin disease or wound infection at the investigational medical device injection site
9. Subjects who participated in another clinical trial within 30 days prior to screening
10. Pregnant or breastfeeding women or women of childbearing potential who are not using medically acceptable contraception or not consenting to practice birth control from screening to the end of trial
11. Subjects who are otherwise determined by the investigator as ineligible for this study
The Real World Efficacy and Safety of Niraparib in Korean Women With Primary and Recurrent Epithelial Ovarian Cancer

1. To evaluate the efficacy and safety of niraparib in Korean women with primary and recurrent epithelial ovarian cancer who underwent niraparib maintenance therapy
2. To evaluate the efficacy and safety of salvage niraparib therapy in Korean women with heavily pretreated epithelial ovarian cancer.

It has been three years since niraparib was introduced into Korea, and about 600 Korean patients with epithelial ovarian cancer have been treated with this drug. The efficacy and safety of niraparib in primary and recurrent epithelial ovarian cancer were well demonstrated in the NOVA trial and the PRIMA trial, and the efficacy and safety of niraparib in heavily pretreated epithelial ovarian cancer patients were confirmed in the -QUADRA trial. However, safety and efficacy data in Korean women are still scanty. The purpose of this study was to evaluate the safety and efficacy of niraparib in Korean women with primary and recurrent epithelial ovarian cancer.

Eligibility Criteria:
Inclusion Criteria:

* Patients were diagnosed with all histologic type of epithelial ovarian cancer
* Observation cohort (Cohort A): All patients who did not receive any kind of maintenance therapy for primary epithelial ovarian cancer from Dec 2019 to Dec 2022
* Treatment cohort: Epithelial ovarian cancer patients who treated with niraparib as maintenance treatment in any line from Dec 2019 to Dec 2022

  * Cohort B: All patients who received or who are receiving niraparib maintenance therapy for primary epithelial ovarian cancer in 1st line setting
  * Cohort C: All patients who received or who are receiving niraparib maintenance therapy for recurrent epithelial ovarian cancer in 2nd or 3rd line setting
  * Cohort D: All patients who received or who are receiving salvage niraparib therapy for recurrent epithelial ovarian cancer in 4th line or more line setting

Exclusion Criteria:

* Borderline ovarian tumor
* Malignant ovarian germ cell tumor
* Malignant sex-cord stroma tumor
* Other malignancy within 5 years of diagnosis of epithelial ovarian cancer excluding carcinoma in situ of uterine cervix, endometrium, bladder, stomach, papillary thyroid cancer, and non-melanoma skin cancer
Beta Glucan's Effect on Pembrolizumab Immunologic Response in Stage III-IV Melanoma

The purpose of this study is to determine how beta-glucan affects the immune system in subjects with melanoma.

This is a clinical pilot study using oral beta-glucan on patients with advanced stage III-IV melanoma without evidence of disease receiving adjuvant Pembrolizumab. The aim is to see whether beta-glucan treatment in combination with Pembrolizumab may provide augmented immunologic phenotypes such as decreased peripheral MDSCs, enhanced T effector cell function, or enhanced cytokine production in the peripheral blood or plasm of enrolled subjects. Secondary outcome measures will include clinical endpoints such as recurrence, progression free survival and overall survival.

Eligibility Criteria:
Inclusion Criteria:

* Any patients with suspected (clinical) or definitive (tissue) diagnosis of Stage III-IV melanoma starting or continuing adjuvant Pembrolizumab without active evidence of disease (NED).
* Must be treatment naïve or have had treatment no less than 6 months prior to enrollment
* 18 years or older
* Must be able to take pills
* ECOG performance status of 0-3
* Ability to understand and willingness to sign a written informed consent
* Members of all racial and ethnic groups are eligible for this study

Exclusion Criteria:

* History of hypersensitivity reactions attributed to beta-glucan
* Patients receiving continuous or other ongoing immunosuppressive therapy
* Uncontrolled intercurrent illness including, but not limited to, autoimmune diseases, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* Any patients who have serious autoimmune toxicity during the study period, or those who have disease recurrence during the 6-week study period should be excluded and analyzed separately
* Patients with mucosal melanoma
* Patients with concurrent malignancy or recent history thereof
Evaluation of Short-term Outcomes of Ambulatory Loop Ileostomy Reversal

Based on enhanced recovery after surgery (ERAS), ambulatory loop ileostomy reversal (ALIR) has been reported in developed countries. However, there is still no research proposing how to carry out ALIR in developing countries. This study was performed to determine the feasibility of ALIR in China based on the community hospital joined enhanced recovery after surgery (CHJ-ERAS) program.

CHJ-ERAS program for ALIR was launched. Patients who underwent loop ileostomy with age ≤ 65 and ASA II or III were enrolled and underwent ALIR after rigorous evaluation. Strict follow-ups were conducted after ALIR. The primary outcome was the results of short-term follow-ups.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with ileostoma and preparing for LIR
2. Patients age between 18-65;
3. ASA grade II;
4. Patients willing to underwent day-case LIR

Exclusion Criteria:

* 1) Patients who underwent single-lumen ileostomy, transverse colostomy or Hartmann; 2) Complex previous laparotomies or required exploratory laparotomy; 3) Age over 65; 4) ASA grade over III (assessed by anesthetists); 5) Presence of moderate or severe preoperative anemia (hemoglobin \<90g/L); 6) Therapeutic anticoagulation or anti-platelet medications used within 1 week before surgery; 7) Patient refusal; 8) Severe co-morbidities or other conditions evaluated by surgeons or anesthetists not inappropriate to be included in the program.
Pilates Method in People With HAM/TSP

Individuals with HTLV-1 secondary myelopathy (HAM/TSP) may have motor and sensory alterations, which may result in reduced functional performance and consequent risk of falls. The aim of the study is to verify the therapeutic effect of a Pilates exercise program on functional performance and risk of falls, when compared to task-oriented training, of people with HAM / TSP. This is a randomized, crossover clinical trial performed with individuals with HAM / TSP who are attended at a referral center who is able to perform gait whether or not to use a walking aid. Amputees, with psychiatric disorders, rheumatic or orthopedic diseases and other associated neurological disorders, which could influence the balance and functional mobility, as well as pregnant women, were excluded. Participants will be submitted to the initial evaluation of functional mobility, balance, gait balance, fatigue, gait endurance, sphincter changes and questioned about the occurrence of falls in the last three months and will answer a semi-structured questionnaire about their conjugality. They will be allocated randomly to two groups. One will perform the Pilates Method protocol and the other task-oriented training. The first group, called test-control group (GTC), will initiate the protocol with exercises of the Pilates method; the control-test group (GCT) will initiate the task-oriented training protocol. A p \<0.05 will be considered a statistically significant difference.


Eligibility Criteria:
Inclusion Criteria:

* individuals with probable and/or defined diagnosis of HAM / TSP, according to WHO criteria, of both sexes, aged 18 to 64 years.

Exclusion Criteria:

* individuals with lower limb amputation, pregnancy, psychiatric disorders, rheumatic or orthopedic diseases, other associated neurological disorders, and those who have difficulty understanding the assessment instruments.
Assessment of an App Based on Artificial Intelligence for Purulent AOM Diagnosis in a Pediatric Department

Otitis media (OM) is one of the most common childhood infections and is a major cause of morbidity in children and results as being the first cause of antibiotic prescription among children in developed countries . An artificial intelligence-based tool could help physicians refine their diagnosis

Ear infections in children are very common, particularly acute otitis media (AOM) which represents the first reason for visiting physicians and for antibiotic prescription in children in developed countries. However, the diagnosis is not easy because of the narrowness of the ear canal, the discomfort of the child during the otoscopic exam. Moreover, the accuracy of the AOM diagnosis depends on the subjectivity of the physician mostly. This can result in an misdiagnosis and inappropriate treatment with, as a result, the emergence of multi-resistant germ.

Artificial intelligence (AI) in medicine is booming and has already proven its worth in terms of prevention, monitoring and diagnosis. I-Nside, an app based on Artificial Intelligence is able to make automatic diagnosis of many ear pathologies, after capturing picture of any eardrum using an otoendoscope fixed on a connected smartphone (SmartScope®).

Therefore, the investigators aim to assess the accuracy of AOM diagnosis the existing app, by comparing the inter-rater agreement between the diagnosis made by a senior physician using a traditional otoscope (considered as "gold standard" ) and the one made by a junior physician using the app

Eligibility Criteria:
Inclusion Criteria:

Child under 18 years Presenting signs that may suggest acute otitis media (fever, earache, purulent otorrhea) For which the informed written consent of, at least, one of the two parents or the holder of parental authority has been obtained

Exclusion Criteria:

A sign (s) of vital distress Trans-tympanic drains

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Prospective Pilot Study of Multi-actor Tolerance Evaluation Using the VIRARE Device (VIrtual Reality Assisted Rehabilitation) in Visually Impaired Patients

Our study aims to validate the relevance of a virtual reality tool (VIRARE: VIrtual REality Assisted Rehabilitation) in the assessment and rehabilitation of visually impaired subjects.


Eligibility Criteria:
Inclusion Criteria:

* The patient signed the consent form
* The patient is affiliated to a health insurance programme
* The patient presents ophthalmological or neurological pathologies with impact on visual function (retinopathy pigmentosa, macular dystrophy, glaucoma, age-related macular degeneration, cerebrovascular accident ...).
* The patient is visually impaired (visual acuity less than 3/10 of both eyes or concentric narrowing of the Goldmann binocular visual field or homonymous hemianopia) of category I, II, III or IV of the WHO classification.

Exclusion Criteria:

* The patient is participating in another study
* The patient is in an exclusion period determined by another study
* The patient is under safeguard of justice.
* The patient is under judicial protection.
* It is not possible to give the patient (or his/her trusted-person) informed information.
* The patient is pregnant or breastfeeding.
* The patient has a sensory or cognitive disability with a given scale (MMS \< 24)
* The patient has difficulty moving including major locomotor difficulties.
A Study Using Cone Beam CT for Head and Neck Cancer

Cone beam CT (computed tomography) is a developing technology which allows CT images to be obtained while a patient is on the radiation treatment table.(A CT scan uses x-rays to produce detailed pictures of structures in the body.) In this study, cone beam CT scans will be obtained before individual radiation treatment sessions for head and neck cancer. The information gathered from these scans will be used by the researchers to look at patient movement as well as changes in the amount of normal and tumor tissue throughout the course of radiation therapy. The researchers will use this information to create hypothetical radiation treatment plans, which will be used as the basis for future research. The cone beam CT scan data will not be used to alter the actual radiation treatment of any of the patients enrolled on the study. In addition, tests of salivary output and swallowing and questionnaires about quality of life will be made to assess how the doses of radiation affect them.


Eligibility Criteria:
Inclusion Criteria:

* Patients of all ages ≥18, both sexes, and all races will be included in this study. Pregnant females will be excluded. No other special classes of subjects (i.e., prisoners) will be entered.
* Patients must be diagnosed with biopsy-proven squamous cell carcinoma of the head and neck.
* Patients must be recommended treatment with definitive radiation therapy with concurrent chemotherapy, but without prior surgical resection of the primary tumor or lymph nodes
* Patients must be recommended a treatment course of at least 30 radiation fractions
* Patients must sign an informed consent form approved for this purpose by the Institutional Review Board (IRB) of the University of Michigan Hospital indicating that they are aware that undergoing cone beam CT of the head and neck is voluntary and has potential risks.

Exclusion Criteria:

* Patients must not have a history of prior radiation to the head or neck
Prognostic Value of Heart-type Fatty Acid-Binding Protein (h-FABP) in Acute Pulmonary Embolism

The patients presenting with acute pulmonary embolism and right ventricular dysfunction are at high risk for life-threatening events and must be identified in the emergency department for adequate care and hospital admission. Echocardiography can identify right ventricular dysfunction, but this test is not always available, and echocardiographic criteria of right ventricular dysfunction vary among published studies. The primary purpose of this protocol is to study the prognostic value of a cardiac biomarker, h-FABP (heart-type Fatty Acid-Binding Protein) , to identify in the emergency department the patients presenting with high risk pulmonary embolism. As secondary outcomes, H-FABP results will be compared to other cardiac biomarkers (BNP, troponin) and clinical score performances that have been previously studied to stratify the prognosis of patients with pulmonary embolism in the emergency department.


Eligibility Criteria:
Inclusion Criteria:

* patients with acute pulmonary embolism diagnosed in the emergency departement

Exclusion Criteria:

* patient under guardianship
* patient without social insurance
* pregnant women
* refusal to sign the consent
* myocardial infarction in the 10 days before pulmonary embolism
Role of Faecal Calprotectin in Patients With Abdominal Pain

The evaluation of patients with abdominal pain is a challenge for the emergency physician and the selection of patients for second-level radiological examinations or endoscopic procedures is not always easy to perform. Faecal calprotectin could be a useful diagnostic marker to distinguish between "organic" or "functional" form and its determination could be helpful to select patients for further examinations, in the context of emergency setting.


Eligibility Criteria:
Inclusion Criteria:

* patients with abdominal pain and/or diarrhea and/or rectal bleeding

Exclusion Criteria:

* patients with age \< 18 years
* pregnant women;
* patients with oncological, cardiological, nephrological terminal diseases;
* patients on antibiotic therapy or who have taken it during the last month;
* patients with a history of colic resection or gastrointestinal surgery;
* patients with a previous diagnosis of inflammatory bowel disease (Crohn's disease, ulcerative colitis)
Efficiency of a Telemedicine-based Follow-up on for the Medical Management of Patients Leaving the Intensive Care Unit

Patients surviving to a stay in intensive care unit (ICU) are likely to require specific care and follow-up after their ICU stay, in order to manage the serious illness at the origin of the ICU stay and any sequelae, but also to adapt the treatments and prevent new complications. At present, there is no specific care chain after ICU.

In order to meet this need, we propose the implementation of a care chain integrating telemedicine at home. We compare the current system (lack of specific follow-up) to follow-up by telemedicine at home.


Eligibility Criteria:
Inclusion criteria:

* Adult patient ≥ 18 years old
* Patient admitted to ICU
* Stay in intensive care \> 48h
* Patient having benefited from at least one organ support during the ICU stay: invasive or non-invasive ventilation (including nasal high-flow oxygen therapy), inotropic or vasopressor support, renal replacement therapy)
* Understanding of the French language
* Patient or entourage able to carry out the measures proposed by telemedicine
* Subject affiliated to a social health insurance scheme
* Subject having signed a consent form

Exclusion criteria:

* Subject under guardianship or curatorship
* Pregnancy / lactation
* Voluntary drug poisoning