cyrilzakka/clinical-trials huggingface dataset:
This is a Phase 1 Study to Evaluate the Safety,Tolerability and Virology of CT P59 in Patients With Mild Symptoms of Symptoms of Coronavirus Disease (COVID-19)

This is a Phase I study that randomized, double-blind, Placebo-controlled, Parallel Group, Single Ascending Dose Study to evaluate Safety, Tolerability and Virology of CT-P59 in Patient with Mild Symptoms of Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) Infection.

'CT-P59 is a monoclonal antibody targeted against SARS-CoV-2 spike receptor binding protein as a treatment for SARS CoV 2 infection. CT-P59 is currently being developed by the Sponsor as a potential treatment for SARS-CoV-2 infection. In this study, safety, tolerability and virology of CT-P59 will be evaluated in patient with mild symptoms of SARS-CoV-2 Infection.

Eligibility Criteria:
Inclusion Criteria:

Each patient must meet all of the following criteria to be randomized in this study:

1. Adult male or female patient, aged between 18 to 60 years (both inclusive).
2. Patient with laboratory confirmed SARS-CoV-2 infection by Reverse Transcription Polymerase Chain Reaction (RT-PCR) at Screening.
3. Patient has mild conditions meeting all of the following criteria:

   1. Oxygen saturation ≥ 94% on room air.
   2. Not requiring supplemental oxygen.
4. Onset of symptom is no more than 7 days prior to the study drug administration.

Exclusion Criteria:

1. Patient with severe condition meeting one of the following:

1. Respiratory distress with respiratory rate ≥ 30 breaths/min.
2. Requires supplemental oxygen.
3. Experience shock.
4. Complicated with other organs failure, and intensive care unit monitoring treatment is needed by investigator's discretion.
5. Any other conditions suspected of being severe symptoms of SARS-CoV-2 infection, in the opinion of the investigator, including but not limited to radiographic findings in lung.
Urine-based Detection of Non-muscle Invasive Bladder

Non-muscle invasive bladder cancer (NMIBC), which comprises approximately 75% of bladder tumors, has the highest recurrence rate of all cancers, with around 70% of the patients developing local recurrences, despite elaborated treatments. Uromonitor is a completely Non-Invasive urine based IVD diagnosis test. It´s able to detect Non-muscle invasive bladder cancer with 100% sensitivity and 97,3 % specificity. Regardless of Tumor stage and grade (unlike Cytology). The rate of Uromonitor false positives (2,3%) is actually lower than the rate of Cystoscopy false positives (3,5%).

Non-muscle invasive bladder cancer (NMIBC), which comprises approximately 75% of bladder tumors, has the highest recurrence rate of all cancers, with around 70% of the patients developing local recurrences, despite elaborated treatments. Uromonitor is a completely Non-Invasive urine based IVD diagnosis test. It´s able to detect Non-muscle invasive bladder cancer with 100% sensitivity and 97,3 % specificity. Regardless of Tumor stage and grade (unlike Cytology). The rate of Uromonitor false positives (2,3%) is actually lower than the rate of Cystoscopy false positives (3,5%).

Hypothesis:

The study aims at evaluating the potential clinical impact of a highly sensitive urinary marker, Uromonitor, regarding possible reduction in number of cystoscopies.

We hypothesize that the use of a sensitive urinary marker regarding recurrent tumor will enable us to reduce the number of follow-up cystoscopies without risk of delaying diagnosis of recurrence and progression cystoscopies compared to flexible cystoscopy alone.

We hypothesize that number of tumors missed at follow-up cystoscopy alone or urinary marker alone is identical or in favor of a sensitive urinary marker that can detect sub-visible lesions and the examinations combined identify all tumor recurrences.

Moreover, we hypothesize that tumors missed at follow-up at a given time point are very small and will be identified at next follow-up without increasing the risk of progression and that regular follow-up with cystoscopy alone therefore can be replaced by follow-up with a sensitive urinary biomarker alone - where cystoscopy only is performed if the biomarker is positive.

Eligibility Criteria:
Inclusion Criteria:

* Patients who previously had low grad NMIBC.
* Subjects must provide written informed consent prior to performance of study-specific procedures or assessments, and must be willing to comply with treatment and follow-up.

Exclusion Criteria:

* Clinical suspicion of muscle invasive bladder cancer
* Upper urinary track tumours
* Patients undergoing neoadjuvant chemotherapy based on local protocols
* Metastatic urothelial carcinoma
* Patients recived installation therapy within the last 4 weeks
Flupenthixol and Haloperidol for Treating Cocaine Abuse Schizophrenics - 9

The purpose of this study is to evaluate the safety and efficacy of flupenthixol and haloperidol for cocaine dependence in individuals with schizophrenia/schizoaffective illness.


Eligibility Criteria:
Please contact site for information.
Intraoperative MRI and 5-ALA Guidance to Improve the Extent of Resection in Brain Tumor Surgery

The investigators hypothesize that the rate of radiologically complete resections of contrast-enhancing brain tumors following surgeries aided by use of 5-ALA induced fluorescence guidance and use of an intraoperative ultra-low field MRI is higher compared to surgeries aided by 5-ALA induced fluorescene alone.


Eligibility Criteria:
Inclusion Criteria:

* adult patient (\> 18 years) able to give informed consent
* primary supratentorial intra-axial brain tumor exhibiting contrast enhancement suspected to be malignant glioma
* tumor must be deemed completely resectable by neurosurgeon
* diagnostic MRI

Exclusion Criteria:

* patient unable or unwilling to give informed consent
* infratentorial tumor location
* tumor location in or near eloquent areas
* multifocal tumor
* existance of contraindications to undergo MRI examination
* previous surgical treatment for an intraaxial brain tumor
Melanoma Detection in Switzerland With VECTRA

This study is to compare 2D- and 3D-imaging and routine clinical care in early melanoma detection in a prospective large-scale real-world data set.

This study is to compare the accuracy of combining human and artificial intelligence with its independent application in early melanoma detection. The Artificial Intelligence (AI)-powered 3D Total Body Photography (TBP) Vectra® WB360 system's utility and clinical performance in detecting melanoma in the real-world setting will be compared to the gold standard with clinical assessments by experienced dermatologists, to currently widespread used 2D imaging tools (FotoFinder ATBM® Master) and to the Smartphone-based algorithm application (e.g. SkinVision®). Here included are specific questions regarding the patients' subjective experience, acceptance and evaluation of modern technological examination.

Additionally, the overall psychological burden and worry of melanoma risk or disease, anxiety, depression will be compared in different groups of patients and psychological support need and real uptake of support and its predictors will be investigated in all participants.

To validate the MELVEC (Melanoma Detection in Switzerland with Vectra®) test procedure, an analysis of the measurement repeatability of computer-guided risk assessment scores for early melanoma detection will be performed. A potential benefit of this validation analysis is the optimization of study procedure for future follow-up visits and further enrolled patients in the MELVEC study. Additionally, results will shed light on the reliability of the convolutional neural networks (CNNs) investigated and help formulate recommendations for their current use. Furthermore, results will provide important data for the manufacturers regarding the systems' reliability in clinical application to help future improvement of the respective algorithms.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent of the patient
* Sufficient fluency in German language skills to complete all questionnaires of the study without external assistance
* High-risk criteria for melanoma. For "high risk" one of the following criteria needs to be fulfilled:

  * At least one previous melanoma (including melanoma in situ)
  * A diagnosis of ≥ 100 nevi
  * A diagnosis of ≥ 5 atypical nevi
  * A diagnosis of dysplastic nevus syndrome or known CDKN2A mutation
  * A strong family history (≥ 1 first- and/or second-degree relatives)

Exclusion Criteria:

* Lack of informed consent for study participation.
* Fitzpatrick skin type V-VI.
* Acute psychiatric illness or acute crisis
Adopting the MRD Strategy to Optimize Post-operation Adjuvant Therapies for Early Stage Breast Cancer

This study is a prospective, multi-center, open-label cohort study, with 3 years disease free survival(DFS) as the primary endpoint. We optimize post-operation adjuvant therapy for early stage breast cancer based on the MRD strategy: patients with clinical high risk or post-operation 1st MRD tested positive will receive intensive adjuvant therapy, while patients with low clinical risk and post-operation 1st MRD tested negative will receive standard adjuvant therapy, and the treatment regimens will be adjusted every 3 months according to the change of MRD status. About 100 TNBC patients, 100 HER2+ patients, and 100 ER+ patients are planned to be enrolled.

MRD will be tested with tumor-informed personalized panel in this trail. The adjuvant therapies in the MRD strategy are all standard therapies in guidelines of China or abroad.

Eligibility Criteria:
Inclusion Criteria:

* Subjects aged ≥18 years (inclusive).
* Histologically confirmed, perioperative invasive breast cancer that is resectable without metastasis(stage I-III).
* No anti-breast cancer systematic therapy received, and planning to receive surgery and systemic therapy.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
* With Adequate Organ Function:

  a. Bone marrow function: Hemoglobin ≥ 10 g/dL; Absolute leucocyte count ≥ 4×10\^9/L; Absolute neutrophil count ≥ 1.5×10\^9/L; Platelets ≥ 100 × 10\^9/L; b. Liver function (based on the normal values specified by study site): Serum total bilirubin ≤ 1.5 × the upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN; c. Renal function (based on the normal values specified by study site): Serum creatinine ≤ 1.5 × ULN.
* The patients voluntarily signed an informed consent form.

Exclusion Criteria:

* Known to have other aggressive malignant tumor that is progressing or requires systemic treatment in the past 5 years (does not exclude subjects with skin basal cell carcinoma, skin squamous cell carcinoma, breast ductal carcinoma in situ or cervical cancer in situ that has received curative treatment).
* Have a clear history of neurological or mental disorders, including epilepsy or dementia, etc.; have a history of psychotropic drug abuse or drug abuse.
* Known history of allergy to the drug components in MRD strategy; history of immunodeficiency, or history of organ transplantation.
* There are other concomitant diseases that seriously threaten the patient's safety or affect the patient's completion of the study, such as serious infection, liver disease, cardiovascular disease, kidney disease, respiratory disease or uncontrolled diabetes or dyslipidemia.
* Female patients during pregnancy or lactation.
* The investigator determines that subjects are not appropriate to participate in the study due to other factors.
Effects of ADSC Therapy in Women With POF

The purpose of this study is to determine whether Adipose Derived Stem Cells are effective in the treatment of Premature Ovarian Failure (POF). Stem cell transplantation has been reported to rescue ovarian function in a pre-clinical mouse model of chemotherapy-induced POF; however, maintaining the survival of transplanted cells in human ovarian tissues to enable the POF patients regain ovary function over the long-term and achieving a successful pregnancy remain a troublesome issue. In this study the investigators are aiming to determine whether the CD29+/CD44+ human Adipose Derived Stem Cells could later enable ovaries produce mature oocytes.

The purpose of this study was to explore the therapeutic potency of the adipose derived stem cells (ADSC) transplantation for premature ovarian failure (POF) women underwent Autologous fat transplantation. The serum of each patient were kept and sent for laboratory test before the surgery. 100ml fat was harvested from the abdomen of POF patient using abdominal fat abortion. And ADSC were isolated and cultured in vitro using autologous serum. The biomarkers of ADSC, CD29 and CD44, were detected in the ADSC cultures using Flow cytometry detection. The ADSC were then transplanted directly into bilateral ovaries when cells reach a density of 5-10×106. The clinical conditions of patients were examined at 1, 2, 4 and 8 weeks after the transplantation. Ovarian functions were evaluated by follicle diameter and sexual hormone levels. The follicle number was counted and radiology data were kept for future analysis. To ensure high rate of pregnancy, intercourse under medical guidance may be suggested and hormone replacement treatment may be taken to help the patients conceive.

Main Outcome Measure(s): Serum FSH,LH,E2 levels, recurrence of Menstruation, Antral follicle diameter,and pregnancy.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Premature Ovarian Failure
* Patients show no response to drug treatment
* Willing to receive follow up
* Willing to conceive a baby
* Age between 20 to 39

Exclusion Criteria:

* Patients with few abdominal fat
* Patients with chromosome abnormalities
* Patients with congenital ovarian malformations
* Patients with severe endometriosis
* Patients with thyroid dysfunction
* Patients with pregnancy contraindications
* Patients with hormone replacement therapy contraindications
* Patients with liposuction contraindications
* Past history of ovarian tumors or after radiotherapy
* Can not take the follow-up, or want to take other treatment during the follow-up period
* Patients with immune system diseases
Analysis of Neurodegenerative Process Within Visual Ways In Multiple Sclerosis

This study will interest in the pathophysiology of silent retinal axonal loss in multiple sclerosis. Recent studies have suggested that silent retinal axonal loss (no past history of optic neuritis \[ON\]) may be due to inflammatory lesions within the optic radiations and a transsynaptic degenerative process. The objective is to measure the exact role of silent optic nerve lesion in the occurrence of silent retinal axonal loss by performing OCT, brain and optic nerve MRI in a cohort of patients without recent disease activity.

This study will interest in the neurodegenerative process reported in multiple sclerosis within the visual ways.

Symptomatic and asymptomatic retinal axonal loss in multiple sclerosis (MS) have largely been described. Many recent optical coherence tomography (OCT) studies have suggested that subclinical retinal axonal loss (no past history of optic neuritis \[ON\]) observed in MS mainly due to inflammatory and demyelinating lesions within the optic radiations and a retrograde transsynaptic degenerative process. None of these studies clearly tried to investigate the role of asymptomatic optic nerve lesion(s) in subclinical retinal axonal loss occurence.

The main objective of the study is to measure the exact role of silent optic nerve lesion in the occurrence of silent retinal axonal loss by performing OCT, brain and optic nerve MRI. The study will focus on a cohort of patients without recent disease activity in order to exclude or minimize the risk of recent and old lesion occurence on the visual ways, which could be a bias in our analysis.

Eligibility Criteria:
Inclusion Criteria:

* Relapsing Remitting Multiple Sclerosis (RRMS) patients treated by natalizumab for more than 6 months
* JohnCunninghamVirus (JCV) index \< 0.9
* patients followed in our MS center from the beginning of the disease

Exclusion Criteria:

* ophthalmologic diseases
* diabetes mellitus
* contra-indication to MRI
To Optimize the Therapeutic Pathway of Peginterferon Treatment in Patients With CHB Based on IFNA2p.Ala120Thr /ISGs.

The study is to guide clinical cure of peginterferon alfa-2a treatment in patients with chronic hepatitis B based on the detection of interferon gene mutation (IFNA2p.Ala120Thr) and interferon-stimulated genes (ISGs) detection gene spectrum.

It is estimated that more than 400 million people are infected with hepatitis B virus (HBV) globally.How to make more patients with chronic hepatitis B get clinical treatment through the existing anti-viral treatment is an urgent problem to be solved.This study is a random, multi-center and open experiment,the collaborators includes the second people's hospital of zhongshan city, the eighth people's hospital of guangzhou city, and the first people's hospital of foshan city.

Patients with chronic hepatitis B who were treated with NAs for over 1 year,HBsAg quantification≤1500 IU/mL, HBeAg negative and serum HBV DNA quantification \<100 IU/mL were enrolled in this study. In our study, the enrolled patient's IFNA2p.Ala120Thr without variation and ISGs\>0.05 were divided into two groups. After informed consent , patients were grouped according to their treatment intentions,in one group, patients continued NAs for another 48 weeks. In another group , patients were treated with peg-interferon-2a and NAs for 48 weeks.Patient's BMI, genotype, family history, smoking history, drinking history, other medical history, suspected transmission channels, types and time of use were recorded in this study.Moreover, Patients were assessed every 12 weeks,included liver and kidney function, blood routine, HBV cccDNA, HBeAg quantification, HBsAg quantification, pgRNA and so on.In addition,liver imaging examination and liver hardness test were assessed every six months.

In this study, we will analyze whether clinical cure rates differed between patients with chronic hepatitis B treated with peginterferon alfa-2a and NAs;Bisedes,the baseline interferon variant site variants and changes in interferon-stimulated gene profile expression were analyzed to determine whether they could be used as molecular markers to predict clinical cure with interferon.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 60 years old;
* HBsAg positive, HBsAg quantification≤1500 IU/mL;
* Serum HBV DNA quantification \<100 IU/mL;
* HBeAg negative.

Exclusion Criteria:

* Treated with interferon in the past six months;
* Liver cirrhosis or HCC and other associated tumors;
* Women during pregnancy or lactation;
* With liver disease caused by other causes;
* Combination infection of HIV or other immunodeficiency diseases;
* With diabetes, autoimmune diseases and other organ dysfunction or failure;
* Combination of other serious complications (infection, hepatic encephalopathy,gastrointestinal bleeding, hepatorenal syndrome, etc.);
* Others who cannot be treated with interferon;
* Anyone cannot return to the hospital for follow-up and follow-up visits regularly as planned
Oral Gemifloxacin Versus Intravenous Cefotaxime in Treatment of Spontaneous Bacterial Peritonitis

oral Gemifloxacin versus intravenous Cefotaxime in treatment of spontaneous bacterial peritonitis

Comparative Study between the Efficacy of oral Gemifloxacin and intravenous Cefotaxime in treatment of spontaneous bacterial peritonitis

Eligibility Criteria:
Inclusion Criteria:

* Patients with spontaneous bacterial peritonitis

Exclusion Criteria:

* secondary peritonitis
RespiraConNosotros:a Mobile Application for COVID-19 Respiratory Rehabilitation.

Platform with a mobile application to encourage the performance of respiratory exercises, controlled and supervised by physiotherapists. It also includes recommendations, frequently asked questions and the possibility of contacting by chat or video calls with experts to solve possible doubts.

Currently, the application is ready for use, the registration of users and professionals is enabled and have 20 exercises divided into three intensity levels.

It is available for all platforms (PC, ANDROID, iOS). presents a simple deployment, accessible to the entire population and does not require installation.

In the future, investigators will include more languages, a greater variety of exercises and even other types of therapies. Investigators will also carry out the adaptation to functional diversity with subtitles and voice commands.


Eligibility Criteria:
Inclusion Criteria:

* Respiratory affectation diagnosis
* Internet access to run the application

Exclusion Criteria:

* Presence of contraindications to physical exercise or the lack of comprehensive ability to access the application will be considered.
Reducing Obesity and Type 2 Diabetes in High Risk Youth

Compare the effect of the HEALT\[e\]TEEN program and a HEALTH\[e\]TEEN plus coping skills training delivered to high school students on BMI, nutrition and physical activity behaviors, and self-efficacy over 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Student enrolled in Health, Biology, or Public Health course

Exclusion Criteria:

* Cognitive ability unable to read or respond to questions in program
To Study the Feasibility and Quality of Life of Medial Group Retropharyngeal Node Sparing in Nasopharyngeal Carcinoma

This is an randomized, controlled, phase 3 clinical trial. The purpose of this study is to evaluate whether medial group retropharyngeal node （MRLN） sparing could reduce the incidence of radiation-caused dysphagia and improve patients' quality of life without compromising survival rate.

In this study, patients with non-keratinizing stage T1-4 N0-3 M0 NPC(UICC/AJCC 8th edition), except for patients with MRLN metastasis, are randomly assigned to receive MRLN sparing or prophylactic irradiation . Patients in MRLN sparing group will not routinely receive MRLN irradiation to 56Gy/33Fr; while patients in MRLN prophylactic irradiation group will always receive MRLN irradiation to 56Gy/33Fr. Our primary endpoint is local relapse-free survival (LRFS). Secondary end points include overall survival (OS), incidence of out-field recurrence rate, toxic effects, and quality of life (QOL).All efficacy analyses are conducted in the intention-to treat population, and the safety population include only patients who receive their randomly assigned treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Patients without medial group retropharyngeal node metastasis;
2. Patients with newly histologically confirmed non-keratinizing (according to WHO histologically type);
3. Tumor staged as T1-4N0-3(according to the 8th AJCC edition);
4. No evidence of distant metastasis (M0);
5. Satisfactory performance status: Karnofsky scale (KPS) ≥ 70;
6. Patients must be informed of the investigational nature of this study and give written informed consent.

Exclusion Criteria:

1. Patients with medial group retropharyngeal node metastasis;
2. Aged \> 65 or \< 18;
3. Treatment with palliative intent;
4. Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer;
5. Pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period);
6. With history of previous RT (except for non-melanomatous skin cancers outside intended RT treatment volume);
7. Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes;
8. Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial.