cyrilzakka/clinical-trials huggingface dataset:
PRECISE, a Study to Gather More Information About Bone Fractures and Survival in Castration-resistant PRostate Cancer (CRPC) patiEnts Treated With Radium-223 in Routine Clinical practIce in SwedEn

In this observational study researchers want to gather more information about bone fractures and survival in castration-resistant prostate cancer (CRPC) patients treated with radium-223 in routine clinical practice in Sweden. The goal is to estimate the proportion of new cases (incidence) of symptomatic bone fractures and to estimate the proportion of death occurred in years of observation time per person (person years). Radium-223 (Ra-223) is an alpha particle-emitting radioactive agent approved for the treatment of men with metastatic castration-resistant prostate cancer (mCRPC).


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed adenocarcinoma of the prostate, i.e., the patient is registered in the NPCR (histology other than adenocarcinomas are not registered in the NPCR).
* Start of Ra-223 treatment for mCRPC as an n-th line of treatment, where "n" goes from 1 to 4.
* ECOG performance status of 0-2 at treatment initiation. We will assume that patients starting any of the systemic therapies under study have a performance status of 0-2.

Exclusion Criteria:

* Prior use of Ra-223
* Patients that have participated in a Ra-223 RCT
Kidney Volume in Live Donors Kidney Transplant Donors and Recipients

The investigators aim to investigate the association between renal volume measured through pre-donation CT auto-segmentation and postoperative renal function of both donors and recipients. After establishing the statistical significance of the association, the investigators intend to create and validate predictive models for renal function at surgery, 1 year, and 3 years postoperatively, incorporating various factors known to contribute to renal function deterioration.


Eligibility Criteria:
Inclusion Criteria:

* live donor kidney transplant

Exclusion Criteria:

* donors without preoperative enhanced CT image
Study of the Application of CPAP to Reduce Complications and Improve Lung Cancer Ablation Radiofrequency Treatment

The project aims to study whether the application of a continuous positive airway pressure (CPAP) of 4 cm water vapor is a safe method in pulmonary radiofrequency intervention (PRF) lung cancer under conscious sedation compared with placebo. And, assess whether CPAP prevents atelectasis formation and consequently reduces the potential complications of PRF and improves procedural success


Eligibility Criteria:
Inclusion Criteria:

* male and female aged 18 years and older
* Patient with a scheduled intervention for ablation of pulmonary malignant tumor with radiofrequency .
* Patient able to undergo tests and examinations required by the study.

Exclusion Criteria:

* Patients with CPAP intolerance test.
* Patients with progressive disease in which local treatment is not applicable
* Patients with intercurrent process (pleural effusion, pneumonia, ...).
* Patient unable to understand the proceedings.
* Pregnancy or breastfeeding.
Treatment of Corneal Wounds Emergencies During the COVID-19 Shutdown: Absorbable 10-0 Vicryl Sutures as a Valuable Strategy.

Vicryl (polyglactin) 10-0 resorbable suture is rarely used, little known to ophthalmologists but may offer therapeutic and practical advantages in eligible cases of corneal trauma, particularly during a COVID-19 pandemic.

This has imposed new sanitary restrictions : limited access to the operating room in ophthalmology only for functional emergencies and a drastically reduced capacity for external consultations in favor of teleconsultation. The aim of this study is to evaluate the Vicryl 10-0 (polyglactin 910) resorbable monofilament suture in corneal trauma, rather than classic Nylon 10-0: structural and functional results, and adaptation of postoperative follow-up during a sanitary crisis period.


Eligibility Criteria:
Inclusion Criteria:

* Corneal penetrating injury and/or lamellar laceration

Exclusion Criteria:

* Corneal Penetrating injury trauma requiring necessarily ONLY Nylon 10-0
* Traumatism requiring necessarily a cryopreserved human amniotic membrane (for example)
* Traumatism eligible for biological glue (long-axis wound \< 2 mm)
Budesonide Treatment for Lymphocytic Colitis

The purpose of this study is to determine whether orale budesonide is effective in the treatment of lymphocytic colitis

The purpose of this study is to determine whether orale budesonide is effective in the treatment of lymphocytic colitis

Eligibility Criteria:
Inclusion Criteria:

* lymphocytic colitis
* diarrhea
* effective contraception
* written informed consent

Exclusion Criteria:

* other forms if IBD
* celiac disease
* infectious colitis
* history of colonic surgery
* use of budesonide, 5-ASA, steroids within th previous 4 weeks
* pregnancy, lactation
Fecal Microbiome Transplantation (FMT) in Pediatric Patients Colonized With Antibiotic-resistant Pathogens Before Hematopoietic Stem Cell Transplantation (HSCT)

a clinical trial designed to prospectively assess the safety and effectiveness of fecal microbiota transplantation (FMT) prior to allogeneic hematopoietic stem-cell translation (HSCT) in patients contaminated with antibiotic-resistant pathogens (ARP)

The investigator's question is whether FMT decontaminates ARP and as a result, decreases the risk of severe infection which leads to transplant-related morbidity and mortality after HSCT.

Eligibility Criteria:
Recipients

Inclusion Criteria:

1. detection by microbiology culture in any localization species of:

   * Pseudomonas aeruginosa
   * Clostridium difficile
   * Vancomycin-resistant Enterococcus
   * Streptococcus viridans
   * ESBL Enterobacteriaceae, including Escherichia coli and Klebsiella pneumoniae
   * Stenotrophomonas maltophilia
   * Acinetobacter
   * Methicillin-resistant Staphylococcus aureus
2. Indications for allo-HSCT

Exclusion Criteria:

1. indications for therapy with antibiotics for the next 7 days after FMT
2. Nonstable condition during 1 week before FMT
3. Therapy with antibiotics less than 48 hours before FMT
4. Age less than 3 years
5. Neutrophils count \< 0,5 K/mcL at FMT day and\\or predicted decrease during 2 days after Donors (healthy volunteers)

Inclusion Criteria:

1. Age 3-50 years old
2. Donor choosing order in the absence of contraindications:

1) HLA-match/mismatch HSCT family donor; 2) Closest family relative with whom the recipient lives; 3) Unrelated healthy volunteer from the FRCC PCM bank of frozen transplants

Exclusion Criteria:

1. Presens of:

   * ESBL Esherihia coli
   * Klebsiella pneumoniae
   * Pseudomonas aeruginosa
   * Clostridium difficile
   * MRSA
   * VRE
   * Streptococcus viridans
   * ESBL Enterobacteriaceae
   * Stenotrophomonas maltophilia
   * Acinetobacter in feces by microbiology culture assay
2. Therapy with antibiotics less than 3 months before donation
3. Any infection disease revealed during the screening
4. Latent period of infection disease according to the questionnaire
5. Gut disease
6. Longitudinal treatment with drugs
7. Any diet for 3 months before donation.
8. Obesity (BMI ≥ 30).
A Study of Induction Dosing With PEGASYS (Peginterferon Alfa-2a [40KD]) Plus Copegus in Treatment-Naive Patients With Chronic Hepatitis C

This 4-arm study will compare the efficacy and safety of PEGASYS induction and maintenance dosing, versus standard fixed dosing in combination with Copegus, and the efficacy and safety of higher dose versus standard dose Copegus in combination with PEGASYS. Patients with chronic hepatitis C (CHC) genotype 1 infection of high viral titer, and baseline body weight ≥85 kg, will be randomized to one of 4 groups, to receive one of the following: a) PEGASYS 180 µg subcutaneously (sc) weekly plus Copegus 1200 mg orally (po) daily; b) PEGASYS 180 µg sc weekly plus Copegus 1400-1600 mg po daily; c)PEGASYS 360 µg sc weekly (induction) followed by 180 µg sc weekly (maintenance) plus Copegus 1200 mg po daily; or d) PEGASYS 360 µg sc weekly (induction) followed by 180 µg sc weekly (maintenance) plus Copegus 1400-1600 mg po daily. Following 48 weeks treatment, there will be a 24-week period of treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, ≥18 years of age
* CHC infection, genotype 1
* Hepatitis C virus (HCV) RNA ≥400,000 IU/mL
* Baseline body weight ≥85 kg
* Liver biopsy (within 24 months of first dose) with results consistent with CHC

Exclusion Criteria:

* Previous treatment with interferon, ribavirin, viramidine, levovirin, HCV polymerase or protease inhibitors
* Other forms of liver disease, including liver cancer
* Human immunodeficiency virus infection
Web-based International Multi-Center Clinical Study for Parkinson's Disease

The objectives of this study are (1) to compare the clinical outcome in correlation with the electrode positions estimated by web-based image fusion of the preoperative MRI and the postoperative brain CT taken at a stable period after surgery using mutual information technique in the patients with advanced Parkinson's disease (PD) after bilateral STN DBS and (2) to examine whether the documentation of the electrode position by using mutual information technique at a stable period after unilateral or bilateral STN stimulation provides useful information for the postoperative programming.


Eligibility Criteria:
Inclusion Criteria:

* Advanced Parkinson Disease patients

Exclusion Criteria:

* The patients who have experienced any perioperative or postoperative complications
* The patients with severe cognitive impairment, ongoing psychiatric problems, an unsatisfactory general condition for evaluation, or an inability
A Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Subjects With Genotype 1 Infection

This study seeks to evaluate the efficacy and safety of ABT-493/ABT-530 in participants with Genotype 1 hepatitis C virus infection without cirrhosis


Eligibility Criteria:
Inclusion Criteria:

* Male or female, at least 18 years of age at time of screening.
* Screening laboratory result indicating hepatitis C virus (HCV) genotype 1 (GT1) infection.
* Chronic HCV infection.
* Subject must be HCV treatment-naïve (i.e., patient has never received a single dose of any approved or investigational regimen) or treatment-experienced (has failed prior interferon \[IFN\] or pegylated IFN (pegIFN) with or without ribivarin (RBV), or sofosbuvir (SOF) plus RBV with or without pegIFN therapy).
* Subjects must be non-cirrhotic.

Additional Inclusion Criteria for HCV GT1/human immununovirus type 1 (HIV-1) co-infected patients:

* HIV-1 antiretroviral treatment (ART) naïve with CD4 ≥ 500 cells/mm3 (or CD4+ % ≥ 29%) at Screening and plasma HIV-1 RNA \<1,000 copies/mL at Screening and at least once during the 12 months prior to Screening.

OR

* On a stable, qualifying HIV-1 ART regimen for at least 8 weeks prior to screening, with CD4 ≥ 200 cells/mm3 (or CD4+ % ≥14%) at Screening and plasma HIV-1 RNA \< LLOQ at Screening and at least once during the 12 months prior to Screening.

Exclusion Criteria:

* History of severe, life-threatening or other significant sensitivity to any excipients of the study drugs.
* Female who is pregnant, planning to become pregnant during the study or breastfeeding; or male whose partner is pregnant or planning to become pregnant during the study.
* Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol in the opinion of the investigator.
* Positive test result at Screening for hepatitis B surface antigen (HBsAg).
* HCV genotype performed during screening indicating co-infection with more than one HCV genotype.
* Chronic HIV type 2 (HIV-2) infection.
A Study of the Effectiveness of Venetoclax Tablets in Adult Acute Myeloid Leukemia Participants Ineligible for Standard Induction Therapy in Russian Federation

Acute Myeloid Leukemia (AML) is a cancer of the blood and bone marrow and is the most common acute leukemia in adults. This study will evaluate how well Venetoclax works to treat AML in adult participants who are ineligible for standard induction therapy in Russian Federation.

Venetoclax is a drug approved to treat Acute Myeloid Leukemia. All study participants will receive Venetoclax as prescribed by their study doctor in accordance with approved local label. Adult participants with a diagnosis of AML who are ineligible for standard induction therapy will be enrolled. Around 50 participants will be enrolled in the study in approximately 15 sites in Russian Federation.

Participants will receive venetoclax tablets to be taken by mouth daily according to the approved local label. The duration of the study is approximately 18 months.

There is expected to be no additional burden for participants in this trial. All study visits will occur during routine clinical practice (approximately every 3 months) and participants will be followed for 18 months.


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed acute myeloid leukemia (AML) (de novo or secondary) and eligible to receive Venetoclax as per Russian Ministry of Health label
* Ineligible for standard induction therapy with cytarabine and anthracycline
* Eastern Cooperative Oncology Group (ECOG) score \>2
* White blood cell counts \<25 x 109 per liter
* Started Venetoclax within 4 weeks of enrolling in study

Exclusion Criteria:

* Acute promyelocytic leukemia
* Contraindications to Venetoclax as listed on the approved local label in Russian Federation
* Neuroleukemia - active central nervous system (CNS) involvement
* Participation in a clinical trial with an investigational drug for AML within 30 days prior to Venetoclax treatment initiation
Effects of Web-Based Training on HbA1c, Quality of Life and Depression Levels in Adolescents With Type 1 Diabetes

Objective: This study was conducted to determine the effect of diabetes training on HbA1c, levels of depression and quality of life of Type 1 Diabetes Mellitus adolescents by using the Web-Based Watson Human Care Model.

Methods: The study was conducted with 30 adolescents between 11-18 years old who was followed by Child Endocrinology Department and who accepted to participate in the research. A web page was developed by considering Training Guide for Adolescents with Type 1 Diabetes and processes of Watson Human Care Theory. Live video interviews were done with adolescents in the experiment group on 14 sessions and these interviews were recorded.


Eligibility Criteria:
Inclusion Criteria:

* Internet access in the home environment,
* Having a computer in the home environment and being able to use a person from the child and / or family,
* Adolescent diagnosed with T1 DM at least 6 months ago,
* Adolescent's ability to understand information, read and write in Turkish, and have no problems preventing him from communicating verbally,
* Agreeing to sign the consent form that the family agreed to participate in the study,

Exclusion Criteria:

* The patients, whose families did not agree to participate in the research for various reasons,
* Internet not access in the home environment,
* Adolescent has a chronic disease other than T1 DM,
* Adolescent newly diagnosed with T1 DM,
Pediatric Facial Fracture Study

The goal of this study is to establish a prospective, long-term, comprehensive growth and development study of the pediatric craniofacial skeleton following fracture, whose recruitment is ongoing.

This is a prospective, long-term, comprehensive growth and development study of the pediatric craniofacial skeleton following fracture.

This study will encompass two specific aims:

1. To compare the growth and development of the pediatric craniofacial skeleton after fracture to publish standardized means of dentofacial growth in the Bolton-Brush Growth Study. Patients will be matched according to age, gender, and ethnicity. The status of dental eruption will be recorded as well as the vertical and anteroposterior classification of occlusion. The effect of trauma on the eruption and vitality of permanent teeth will be recorded. We will further assess the popularly held theories of craniofacial growth and effects of injury to various facial growth sites (i.e. mandibular condyles, nasal septum).
2. Attempt to evaluate the effects of various treatment modalities of facial fracture on skeletal growth and development (i.e. open reduction and internal fixation versus closed reduction and external fixation), (open reduction and internal fixation with metallic vs. absorbable fixation). We will evaluate the effect of metallic internal fixation on subsequent craniofacial skeletal growth and development, as well as the routine needed for its removal.

Eligibility Criteria:
Inclusion Criteria:

* Criteria for inclusion in the research study will be any pediatric patient, birth to 18 years, who are in the active phase of craniofacial skeletal growth, and have sustained a craniofacial fracture.
* The racial, gender and ethnic characteristics of the proposed subject population reflects the demographics of the University of Pittsburgh and the surrounding area and/or the patient population of the University of Pittsburgh Medical Center.
* The investigators shall attempt to recruit subjects in respective proportion to these demographics. No exclusion criteria shall be based on race, ethnicity, gender or HIV status.

Exclusion Criteria:

* Criteria for exclusion in the research study will be any pediatric patient, birth to 18 years, who are not in the active phase of craniofacial skeletal growth, and have not sustained a craniofacial fracture.
Efficacy and Safety of Masitinib in the Treatment of Progressive Multiple Sclerosis

The purpose of this study is to compare the safety and efficacy of masitinib 6 mg/kg/day versus placebo in the treatment of patients with primary progressive multiple sclerosis or relapse-free secondary progressive multiple sclerosis.

Masitinib is a selective tyrosine kinase inhibitor that is thought to exert a neuroprotective effect through its activity on mast cells and other non-neuronal cells of the central nervous system, with subsequent modulation of inflammatory and neurodegenerative processes. The objective of this study is to compare the efficacy and safety of masitinib at 4.5 mg/kg/day versus matched placebo, or masitinib at 4.5 mg/kg/day with a dose escalation to 6 mg/kg/day after 3 months of treatment versus matched placebo, in the treatment of patients with primary progressive multiple sclerosis or relapse-free secondary progressive multiple sclerosis. Approximately 600 patients will be randomized into four treatment groups with a 2:2:1:1 design. The primary outcome measure is the Expanded Disability Status Scale (EDSS) after 96 weeks of treatment in the overall study population with subgroup analysis performed in stratum (primary progressive multiple sclerosis / secondary progressive multiple sclerosis).

Eligibility Criteria:
Main inclusion criteria:

- Patient suffering from either primary progressive or secondary progressive multiple sclerosis without relapse within 2 years before inclusion according to the revised McDonald's criteria.

Main exclusion criteria:

- Patient suffering from a disease other than MS that would better explain the patient's neurological clinical signs and symptoms and/or MRI lesions
Application for Sexual Abuse Prevention Based On Empowerment of Parents And School Teachers

The objective of the research is to Analyze the influence of providing the PERAN SADAR Application on the knowledge, attitudes, self-awareness, and communication practices of parents, teachers, children, and adolescents

Participants will get education that is given using the PERAN SADAR_ APPLICATION for 9 consecutive days. Teachers at school and parents at home were encouraged to provide information on preventing sexual abuse to their children after they had read and listened to the information in the PERAN SADAR_ Application. Information was given every day for 1 month. Children were given a knowledge questionnaire (which had been tested for validity and construct in previous studies) before being given an intervention to provide information on preventing sexual violence. After 1 month, knowledge, attitudes, self-awareness, and communication practices were measured for teachers and parents, while knowledge measurements were carried out for children.


Eligibility Criteria:
Inclusion Criteria:

* student at elementary school

Exclusion Criteria:

* sick, refuse to join
A Randomized Phase III Study Comparing POF With SOX/CAPOX/FOLFOX as a Postoperative Adjuvant Chemotherapy for Curatively Resected Stage III Gastric Cancer

FNF-014 is a randomised, open-label, multicentre, parallel-group, phase 3 study in China to prove superiority of POF over S-1/docetaxel in postoperative adjuvant setting for pStage III gastric adenocarcinoma (including adenocarcinoma of the gastrooesophageal junction).


Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 70 years.
* Histologically proven in gastric adenocarcinoma (including adenocarcinoma of the gastrooesophageal junction) of stage IIIA, IIIB, IIIC with no evidence of metastatic disease.
* Subjects must be able to take orally.
* R0 resection with D2 lymph-node dissection with al least 15 lymph nodes were examined to ensure adequate disease classification.
* Previously untreated except for the initial gastric resection for the primary lesion.
* ECOG performance status ≦ 1.
* Able to start chemotherapy with 42 days after gastrectomy.
* Hgb ≧ 9 g/dL, WBC 4000-12000/mm3, platelets ≧ 100,000/mm3
* Creatine ≦ upper normal limit (UNL)
* Total bilirubin ≦ 1.5 X UNL
* AST, ALT and ALP ≦ 2.5 x UNL
* Life expectancy estimated than 3 months
* Written informed consent

Exclusion Criteria:

* Active double cancer
* Gastrointestinal bleeding
* Pregnancy or lactation women, or women with suspected pregnancy or men with willing to get pregnant
* Definite contraindications for the use of corticosteroids
* Any subject judged by the investigator to be unfit for any reason to participate in the study
A Registry to Capture Patient Outcomes With KRAS G12R Altered Advanced Pancreatic Ductal Adenocarcinoma Treated With MEK Inhibitor-based Combination Therapy

This is an observational precision oncology study designed to collect and analyze data that allows us to characterize the safety and efficacy of several different mitogen-activated protein kinase kinase inhibitor (MEKi) -based treatment strategies and the feasibility of administering MEKi combination therapies to patients with KRAS G12R mutated advanced pancreatic ductal adenocarcinoma (PDAC).

Patient medical records, obtained both retrospectively and prospectively, will be examined for results of molecular profiling obtained through standard of care testing to help understand how well KRAS G12R pancreatic patients respond to MEKi-based combination matched therapy. Patient outcome parameters including but not limited to tumor response, patient survival, and toxicity will be analyzed. Moreover, metrics will be collected to ascertain whether a future clinical trial involving a MEKi-based combination therapy is feasible to carry out.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years.
2. Diagnosis of advanced pancreatic ductal adenocarcinoma as determined by the treating physician or tumor board.
3. Tumor must have KRAS G12R mutation, as determined by a next generation sequencing (NGS) panel or circulating tumor DNA panel of choice of the treating physician.
4. Ability to understand a written informed consent document and the willingness to sign it.

Exclusion Criteria:

1. Age \<18 years.
2. Primary cancer diagnosis other than advanced pancreatic ductal adenocarcinoma
3. Tumor does not have a KRAS G12R mutation.