cyrilzakka/clinical-trials huggingface dataset:
Immunogenicity of 9-valent HPV Vaccine

Human papillomavirus (HPV) causes the most prevalent sexually transmitted infections in the world. The nonavalent HPV vaccine (9vHPV) provides protection against 9 high-risk HPV serotypes, responsible for causing approximately 90% of cervical and other HPV-related anogenital cancers, as well as 90% of genital warts. The risk of cancer is substantially increased among immunocompromised patients.

Although studies have demonstrated seroprotection among children and adolescents, boys and girls, with the 9vHPV vaccine, the immunogenicity of this vaccine has been poorly explored in immunocompromised children and adolescents (including transplant patients, and those infected with human immunodeficiency virus (HIV)). Several factors, including the immunological consequences of vertically acquired infection, immunosuppressive therapies and age, could lead to an increased risk of infection in children and adolescents who are immunocompromised. Lower immunogenicity in these populations. These children may have a poor response to vaccines and therefore require additional doses. Markers such as CD4/CD8 or torque teno virus (TTV) replication could be linked to immunogenicity and thus serve as predictors of efficacy for routine clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Children or adolescents 9 to \<18 years of age
* Willing to sign consent/assent form
* If HIV positive, under ART and undetectable viral load and CD4 cell count \>200/mm3 (at least 6 months)
* If the patient has received chemotherapy or is a SOT/HSCT recipient, referred for immunizations after adequate immune reconstitution according to routine clinical practice

Exclusion Criteria:

* Previous history of warts and/or anal cancer.
* Previous immunization with any HPV vaccine.
* Age below 9.
* Patients who for any reason should not be included in the study according to the evaluation of the research team.
Independent Risk Factors Analysis and Model Construction For Recurrence After Radiofrequency/Microwave Ablation of Colorectal Cancer With Liver Metastases: a Retrospective, Multicenter Trial

This study is a retrospective, multicenter clinical study. The main objective is to analyze the risk factors affecting the recurrence of colorectal cancer patients with liver metastases who received radiofrequency/microwave ablation. Finally, we will construct a recurrence risk prediction model based on the risk factors and validated the model.


Eligibility Criteria:
Inclusion Criteria:

1. Age：older than 18 years；
2. Patients with a single tumor diameter ≤5cm, no more than 3 tumor nodules, and the largest tumor diameter ≤3cm；
3. Absence of vessel, bile duct and adjacent organ invasion and distant metastasis;
4. The primary tumor of colorectal cancer has been resected, the liver metastases cannot be resected or the patient is unwilling to undergo surgery (clinical or pathological confirmation);
5. Normal coagulation status and liver function child-pugh A or B;
6. Liver metastases have not received other antitumor therapy after radiofrequency/microwave therapy (before disease progression);
7. Routine laboratory tests were performed before the first RF/microwave treatment;
8. Follow up for more than 12 months;
9. Obtained free informed consent.

Exclusion Criteria:

1. Large tumor, or diffuse intrahepatic metastasis;
2. Accompanied by vascular tumor thrombus or invasion of adjacent organs;
3. The primary tumor of colorectal cancer has not been resected, with extrahepatic metastasis;
4. Uncorrectable coagulation dysfunction and severe blood abnormalities, those with severe bleeding tendency;
5. Intractable massive ascites, cachexia;
6. Active infection, especially inflammation of the biliary system;
7. Severe liver, kidney, heart, lung, brain and other major organ failure;
8. Patients with impaired consciousness or unable to cooperate with treatment;
9. Missing follow-up data.
A Prospective, Multicenter Study on Best Clinical Use of Imatinib in the Advanced Gastrointestinal Stromal Tumors

Open-label, multicenter study of imatinib (400mg/die p.o.)in patients with advanced gastrointestinal stromal tumors. Patients will be treated for up to 12 months. Data regarding its best clinical use in terms of tumor response, survival, tolerability and safety profile will be prospectively collected.


Eligibility Criteria:
Inclusion Criteria:

1. Patients ≥ 18 years of age.
2. Histologically documented diagnosis of GIST, unresectable and/or metastatic and therefore incurable with any conventional multimodality approach.
3. Immunohistochemical documentation of c-kit (CD117) expression by tumor, as detected on a tumor sample taken within 6 weeks of study entry.
4. At least one measurable site of disease (RECIST Criteria), or other response assessment criteria, as appropriate.
5. Performance status 0,1, 2 or 3 (ECOG).
6. Adequate end organ function.
7. Adequate bone marrow function.
8. Female patients of child-bearing potential must have negative pregnancy test within 7 days before initiation of study drug dosing.

Exclusion Criteria:

1. Previous treatment with any other investigational agents within 28 days of first day of study drug dosing, unless the disease is rapidly progressing.
2. Other primary malignancy with \< 5 years clinically assessed disease free interval, except basal cell skin cancer, cervical carcinoma in situ, or other neoplasms judged after consultation with the Steering committee to entail a low risk of relapse.
3. Grade III/IV cardiac problems as defined by the New York Heart Association Criteria.
4. Pregnancy, breast-feeding.
5. Severe and/or uncontrolled medical disease.
6. Known brain metastasis.
7. Known chronic liver disease (i.e., chronic active hepatitis, and cirrhosis).
8. Known diagnosis of human immunodeficiency virus (HIV) infection.
9. Previous treatment with chemotherapy within 4 weeks (6 weeks for nitrosoureas or Mitomycin-C).
10. Previous radiotherapy to ≥ 25 % of the bone marrow.
11. Major surgery within 2 weeks prior to study entry.
Sports Participation in Children and Adolescents With Type 1 Diabetes Mellitus

On the basis of a questionnaire the participation at sports activities of children and adolescents with type 1 diabetes mellitus will be studied. The occurrence of hypoglycemia and hyperglycemia will be evaluated, as well as the measures to prevent these complications.


Eligibility Criteria:
Inclusion Criteria:

* Children and adolescents with type 1 diabetes mellitus followed at the pediatric diabetes clinic of the Jessa Hospital

Exclusion Criteria:

-
A Phase 1, Open-label, Multiple Dose Escalation Trial to Determine Safety and Tolerability of Once Daily OPB-111077 in Subjects With Advanced Cancer

The primary objective of this study is to determine the safe and tolerable dose level of OPB-111077 for patients with advanced cancer.

The secondary objective of this study is to investigate the pharmacokinetic properties of OPB-111077; the pharmacodynamic effects of OPB-111077; the antitumor activity of OPB-111077 as assessed by RECIST or IMWG Uniform Response Criteria; and to explore whether PET responses correlate with other measures of clinical response.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically and/or cytologically confirmed advanced malignancy that is refractory to standard therapy or for which there are no standard treatment options available
* For oral or intravenous anticancer therapies, at least 4 weeks or 5 half-lives, whichever is shorter, need to have elapsed since the last dose
* Recovery from adverse effects of prior therapy at time of enrollment to

  o ≤ Grade 1 (excluding alopecia)
* Agreement to forego any other chemotherapy, immunotherapy, radiotherapy, or investigational drug while enrolled on this trial except hormonal therapy for prostate cancer or radiotherapy for symptomatic bone metastases known to be present at Screening
* Male or female subjects aged ≥ 18 years
* ECOG performance status ≤ 2
* Adequate organ function
* Life expectancy of ≥ 3 months following trial entry
* For women of childbearing potential, a negative serum pregnancy test result at Screening
* For women of childbearing potential or men whose sexual partners are women of childbearing potential, agreement to use 2 methods of adequate contraception prior to trial entry, for the duration of the trial, and for 90 days after the last dose of trial medication
* Signed and dated IRB-approved informed consent prior to any performance of protocol-specific screening procedures

Exclusion Criteria:

* Uncontrolled concurrent illness, including but not limited to: ongoing or active infection; uncontrolled heart, liver, kidney, or endocrine disorder
* Altered mental status, psychiatric illness, or social situation that would limit compliance with trial requirements and/or obscure trial results
* Immunocompromised state
* Known or evidence of chronic viral hepatitis (hepatitis B or C virus)
* Untreated or symptomatic brain metastasis, or subjects with leptomeningeal disease
* Inability to swallow oral meds or gastrointestinal disorder that might interfere with absorption of oral drugs
* Major surgery within 28 days of first receipt of trial drug
* Nursing or pregnant women
* ≥ Grade 1 neuropathy with pain or \> Grade 2 neuropathy without pain (subjects with neuropathy caused by a previous regimen that is recovered to ≤ Grade 2 and stable without pain may be included)
* Food-effect sub-study (Part B) only: Pathologies or medical histories that might impair absorption and elimination.
* PET scan sub-study (Part C) only: Uncontrollable blood glucose or intolerance to PET scan procedures.
Self-Directed Positive Psychology Intervention for Newly Diagnosed Multiple Sclerosis

The goal of this clinical trial is to learn whether positive psychology (PP) exercises such as writing a letter of gratitude or remembering a past success can help individuals with newly diagnosed multiple sclerosis (MS) to feel more hopeful, happy, and healthy. The main questions it aims to answer are:

* Is a five-week self-directed PP training intervention feasible and acceptable to individuals with newly diagnosed MS?
* Does the completion of a five-week self-directed PP training intervention improve positive affect, emotional function and health-related quality of life (HRQOL) in individuals with newly diagnosed MS?
* Are improvements in positive affect, emotional function and HRQOL maintained after the completion of the intervention?

Participants will be randomized to the intervention or waitlist control group. There will be an intervention phase (weeks 1-5) and an extension phase (weeks 6-10). All participants will complete questionnaires at enrollment, 5 weeks and 10 weeks. They will complete 5 weeks of self-directed PP training exercises, either during the intervention phase (intervention group) or extension phase (waitlist control group) of the study.

Researchers will compare participants in the intervention and waitlist control groups at the end of the intervention phase to see if there are improvements in positive affect, emotional function and HRQOL. For subjects in the intervention group who demonstrate improvement, researchers will determine if the benefit is maintained by comparing positive affect, emotional function and HRQOL at the completion of the intervention and extension phases of the study.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of MS according to the McDonald 2017 diagnostic criteria
* Onset of disease within the last 2 years
* Ability to speak, read and write in English

Exclusion Criteria:

• Moderate or marked cognitive abnormalities identified by the treating neurologist during routine clinical visits that would preclude meaningful participation in the PP exercises
Dihydroartemisinin-piperaquine and Primaquine for Uncomplicated Plasmodium Falciparum Cases

Artemisinin-based combination therapy (ACT) has been known to be controversial for stopping malaria transmission.The addition of primaquine (PQ) - the only drug commercially available that kills mature transmission stage - to such treatments might be necessary to eliminate this stage. A study is conducted to evaluate the efficacy of dihydroartemisinin-piperaquine (DHP) regimens with or without PQ on the sexual and asexual stages of P. falciparum in Sumatra, Indonesia.

The study was conducted in Hanura Primary Health Center, Padang Cermin district, Lampung province (105°45'-103°48'E and 3°45'-6°45'S) located at the southern end of Sumatra island.

The study subjects received either 3 day doses of dihydroartemisinin-piperaquine with or without 1 day of primaquine according to their body weight.

Patients with fever or history of fever within the past 24 hours were screened by microscopic examination of Giemsa-stained thick blood films to detect P. falciparum infection.

All subjects were allocated by open-label randomization to receive DHP alone (on Day 0 to Day 2) or DHP plus a single dose of PQ (Day 3). The procedures of drug administration in the study were as follows:

Eligibility Criteria:
Inclusion Criteria:

* age ≥ 4 years old
* parasite count ≥ 1,000 asexual parasites/µL
* normal glucose-6-phosphate dehydrogenase enzyme level based on qualitative test (Trinity Biotech® no 203, USA)
* hemoglobin level ≥ 8 gr/dL as measured by Hemoque® apparatus;
* have the ability to return for 42-day-follow up and
* willingness to sign the informed-consent form.

Exclusion Criteria:

* are infected with other r plasmodium species
* have only gametocytes of P. falciparum;
* are pregnant - measured by positive result on HCG urine test and/or breastfeeding women
* present signs of pitting edema on both legs as a sign of malnutrition
* have complicated or severe malaria, other chronic diseases or history of drug allergies.
Immunogenicity & Safety Study of a Meningococcal Serogroup B Vaccine Given in a 3 Dose Schedule to Healthy Adolescents Aged 12-18 Yrs

The purpose of this study is to evaluate the immunogenicity, safety and reactogenicity of 3 doses of the meningococcal serogroup B vaccine when given, using either a 0-2-4 month or a 0-1-6 month schedule, to healthy adolescents aged 12-18 years; a control group will receive 2 doses of Havrix™ (0-6 months) and Meningitec™ (month 1).

The study is open; however, vaccines given to study group at 0-1-6 months and to control group will be administered in an observer-blind manner. 3 blood samplings for antibody testing: before vaccination and one month after the second and third vaccine doses.

Eligibility Criteria:
Inclusion Criteria:

* Healthy males or females between, and including, 12 and 18 years of age at the time of the first vaccination.
* Female subjects must be of non-childbearing potential.

Exclusion Criteria:

* Previous vaccination against or history of meningococcal B or C, or hepatitis A disease or exposure to meningococcal B disease within last year.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
* Family history of congenital or hereditary immunodeficiency.
* History of any neurologic disorders or seizures.
High Intensity Laser Therapy in the Treatment of Hemiplegic Shoulder Pain

High intensity laser therapy (HILT) has been considered as a treatment option for shoulder pain. In randomized controlled studies with high-intensity laser therapy (HILT), there are publications showing its effectiveness in conditions such as shoulder pathologies such as subacromial impigment syndrome and adhesive capsulitis. However, there are few studies in the literature that focus on the effectiveness of HILT, especially in hemiplegic shoulder pain. In this study, we intended to investigate the effectiveness of HILT on pain, disability, function and quality of life in patients with HSP accompanied by PTRCT.

The study was designed as prospective, randomized, controlled trial. Patients with HSP accompanied by PTRCT (n=40) were randomly assigned to HILT and control groups. Group 1 (HILT group, n=20) received 3 sessions of HILT per week for 3 weeks in addition to the exercise program which performed 5 sessions per week for 3 weeks. Group 2 (Control group, n=20) received an exercise program for HSP of 5 sessions per week for 3 weeks.

Participants were evaluated with Visual Analog Scale (VAS), passive Range of Motion (ROM), Shoulder Pain and Disability Index (SPADI), Nottingham Health Profile (NHP), Functional Independence Measure (FIM) and ultrasonographic PTRCT size,Fugl Meyer Assessment, Brunnstrom Stages, Modified Ashworth Scale (MAS) Nottingham Health Profile (NHP).

Eligibility Criteria:
Inclusion Criteria:

* Patients with HSP aged 50-85 years with hemiplegia duration\> 2 months, suffered a stroke resulting in unilateral hemiplegia for the first time

Exclusion Criteria:

* Cases who had inflammatory rheumatic disease, cervical radiculopathy, diabetes mellitus, thyroid disease, coronary heart disease, cardiac pace-maker, neurological disease, shoulder surgery, and shoulder injection in the last 3 months
Phase II Clinical Trial of OCH-NCNP1

This study is designed to assess the efficacy and safety of OCH-NCNP1 compared to placebo in subjects diagnosed with relapsing remitting multiple sclerosis (RRMS) and secondary progressive mltiple sclerosis (SPMS) .


Eligibility Criteria:
Inclusion Criteria:

* Subject with Multiple Sclerosis eligible for enrolment in the study must meet all of the following criteria:

  1. Provision of written informed consent to participate in this study
  2. Patients diagnosed as relapsing remitting multiple sclerosis based on modified McDonald criteria in 2017
  3. Relape must have been confirmed by a neurologist at least twice within 24 months, or once within 12 months before enrollment
  4. Have at least one T2 lesion on MRI scans at screening
  5. EDSS less than or equal to 7
  6. 20 =\< Age \< 65
  7. Promise to prevent conception for at least 90 days after the last administration
  8. Neurological stability has been confirmed by a neurologist

Exclusion Criteria:

* Subject with MS patients meeting any of the following criteria must not be enrolled in the study:

  1. Diagnosed as Neuromyelitis Optica
  2. Women who are pregnant or lactating
  3. Patients who is prohibited MRI
  4. Patients who are allergic to Gd-contrast medium
  5. History of liver diseases or liver transplantation
  6. Liver dysfunction in the screening test and baseline physical examination
  7. History of cancer past five years
  8. Negative for herpes zoster virus antibody
  9. Positive for Syphilis serum reaction
  10. Positive for Beta-glucan or positive for T-spot
  11. Positive for Anti-Aquaporin 4 antibody
  12. History of HIV infection
  13. History of HBV or HCV infection
  14. History of Transplantation
  15. Use of any other investigational agents and/or experimental agents within 4 months prior to the first anticipated administration of study medication.
  16. History of blood donation (200 ml within 2 months, 400 ml within 3 months) prior to the first anticipated administration of study medication
  17. Lymphocyte number \< 600 /mm3 in peripheral blood
  18. Current diagnosed or suspected infectious diseases
  19. Compromised Patients
  20. Inflammatory Bowel disease
  21. Subjects with prolongation of QT/QTc interval
  22. History or have risk of torsade de pointes
  23. Taking the medicine which has risk of prolongation of QT/QTc interval
  24. History of severe allergy of medicine or food
  25. History or current of drug/ alcohol addiction
  26. Bronchial Asthma
  27. Epilepsy Other protocol-defined exclusion criteria may apply
Study Evaluating Multiple Oral Doses of PPM-204 in Healthy Japanese Male Subjects

A study evaluating the safety and pharmacokinetics of multiple oral doses of an investigational oral diabetic agent when given to healthy Japanese male volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Men, aged 20 to 45 years, inclusive
* Body mass index in the range of 17.6 to 26.4 kg/m2
* Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead electrocardiogram (ECG)

Exclusion Criteria:

* History of cardiac, thyroid, muscle, and kidney abnormalities
* History of NSAID induced bronchospasm or asthma
* History of any clinically important allergies
Phase 2 Efficacy Study of Primaquine and Methylene Blue

The purpose of this study is to determine the most efficacious transmission blocking drug regimen for seasonal malaria chemoprophylaxis in Mali. The primary outcome measure will be the proportion of mosquitoes infected pre and post-treatment, assessed through membrane feeding and measured by oocyst prevalence in mosquitoes dissected on day 7 post feed. Primary endpoint will be a within group comparison between the mean of the pretreatment infectivity (Day 0) and infectivity at 7 days post first dose.

Protocol will be shared on request.

Eligibility Criteria:
Inclusion Criteria:

* Glucose-6-phosphate dehydrogenase (G6PD) normal defined by CareStart™ G6PD rapid diagnostic test (RDT) or the OSMMR2000 G6PD semi-qualitative test
* Absence of symptomatic falciparum malaria, defined by fever upon enrollment
* Presence of P. falciparum gametocytes on thick blood film at a density \>30 gametocytes/µL (i.e. ≥2 gametocytes recorded in the thick film against 500 white blood cells)
* No allergies to study drugs
* No self-reported use of antimalarial drugs over the past 7 days (as reported by the participant)
* Hemoglobin ≥ 10 g/dL
* Individuals weighing \<80 kg
* No evidence of severe or chronic disease
* Written, informed consent

Exclusion Criteria:

* Age \< 5 years or \> 50 years
* Female gender
* Blood thick film negative for sexual stages of malaria
* Previous reaction to study drugs/known allergy to study drugs
* Signs of severe malaria, including hyperparasitemia, defined as asexual parasitemia \> 100,000 parasites / µL)
* Signs of acute or chronic illness, including hepatitis
* Use of other medications (with the exception of paracetamol and/or aspirin)
* Consent not given
Comparison of Propofol and Sevoflurane as Maintaining Anesthetics During General Anesthesia of Cesarean Section

Sevoflurane and propofol are the most popular drug choices for maintenance of general anaesthesia for caesarean section. However, effects of these two anesthetics on maternal and fetal outcomes after caesarean section haven't been compared directly. The aim of this study is to compare the effects of sevoflurane and propofol as maintenance of general anesthesia, and to try to determine which anesthetic is better for maternal and fetal outcomes after caesarean section.

General anaesthesia is mostly performed for emergency grade 1 caesarean section and due to a lack of time to apply a neuraxial anaesthesia technique. Rapid sequence induction using propofol and rocuronium should become the standard for general anaesthesia in the obstetric patient. Both sevoflurane and propofol are considered to be appropriate for the maintenance of general anaesthesia during caesarean section. However, effects of these two anesthetics on maternal and fetal outcomes after caesarean section haven't been compared directly in the past. And for most anaesthesiologists, the clinical experience with general anaesthesia for caesarean section is very low. This study is to compare the effects of sevoflurane and propofol as maintenance of general anesthesia.

Eligibility Criteria:
Inclusion Criteria:

* ASAⅠor Ⅱ parturients (aged 18-35 years) undergoing elective caesarean section

Exclusion Criteria:

* Parturients with severe pregnancy complications