cyrilzakka/clinical-trials huggingface dataset:
A Randomized, Double-blind, Placebo-controlled, Five Parallel Groups Efficacy and Safety Study of NS 2330 (Tesofensine) (0.125 mg, 0.25 mg, 0.5 mg and 1.0 mg) Administered Orally Once Daily Over 14 Weeks in Levodopa Treated Parkinson Patients With Motor Fluctuations

The primary objective of this exploratory study is to investigate the efficacy and safety of tesofensine in daily doses (from 0.125 mg to 1.0 mg) in comparison to placebo, over a 14-week treatment period in levodopa treated Parkinson patients with motor fluctuations.

This is a randomized, double-blind, placebo-controlled, five parallel groups efficacy and safety exploratory of tesofensine versus placebo in levodopa treated Parkinson patients with motor fluctuations.

Patients will be treated either with one of the 4 doses of tesofensine (0.125mg, 0.25mg, 0.50 mg or 1.0 mg) or with placebo, once daily, over 14 weeks.

The two co-primary efficacy endpoints are the change in off-time and the change in the Unified Parkinson Disease Rating Scale (UPDRS) II+III total score

Study Hypothesis:

The null hypothesis is that there is no difference between placebo and tesofensine.

The alternative hypothesis is that treatment with tesofensine is superior to treatment with placebo.

Comparison(s):

For the primary comparison between tesofensine and placebo, change in percentage off-time during waking hours will be based on reports from patient's diary (completed at day -3 and day-2 prior to the study visits) and change in the UPDRS II+III will be based on UPDRS II averaged for on and off periods and UPDRS III evaluated at on periods during the study visits.

Eligibility Criteria:
Main inclusion criteria:

* Male or female patient with idiopathic Parkinson Disease (PD) diagnosed for at least 2 years.
* Patient aged 40 years or over at time of diagnosis of PD and not older than 80 years at screening visit.
* Modified Hoehn and Yahr stage of II to III at "on" time.
* Treatment with Levodopa at an optimised dose, 4 to 8 times per day, this dose being stable for at least 4 weeks prior to screening visit.
* Motor fluctuations, with 2.0 to 6.0 cumulative hours of "off" time every day during waking hours, documented from patient's diary completed for 2 consecutive days before baseline visit.

Main exclusion criteria:

* Neuropsychiatric exclusions: Non-idiopathic PD, dementia (Mini Mental State Exam \<26), history of psychosis, history or current Axis I or Axis II mental disorder according to DSM-IV, etc
* Other medical exclusions, like ECG abnormalities, hypotension and/or symptomatic orthostatic hypotension, some abnormal laboratory parameters (e.g. severe renal impairment), etc
* Pharmacological exclusions, e.g. selegiline within 8 weeks prior to screening visit, regular use of anti-depressant drugs, any medication with central dopaminergic antagonist activity, etc
Group Versus Internet-based Cognitive Behavior Therapy for Procrastination

Procrastination is defined as a voluntarily delay of an intended course of action despite expecting to be worse-off for the delay, and is considered a persistent behavior pattern that can result in major psychological suffering. About one-fifth of the adult population and half of the student population are presumed having substantial difficulties due to recurrent procrastination in their everyday life. However, chronic and severe procrastinators seldom receive adequate care due to preconceptions and the lack of understanding regarding procrastination and the treatment interventions that are assumed beneficial. Cognitive behavior therapy is often deemed treatment of choice, although the evidence supporting its use is scarce, and only one randomized controlled trial has been performed. The primary aim of the current study is therefore to test the efficacy of cognitive behavior therapy delivered as either a group intervention or via the Internet. Participants will consist of students recruited through the Student Health Centre at Karolinska Institutet. A randomized controlled trial with a sample size of 100 participants divided into two conditions will be employed; a ten week Internet-based cognitive behavior therapy intervention, and an eight week group intervention based on cognitive behavior therapy. The current study is believed to result in two important findings. First, different interventions inherent in cognitive behavior therapy are assumed to be helpful for people suffering from problems caused by procrastination. Second, both a group intervention and an Internet-based cognitive behavior therapy intervention are presumed suitable for administering treatment for procrastination, which is considered highly important as the availability of adequate care is limited, particularly among students. The current study will increase the knowledge regarding the efficacy of different treatments of procrastination, as well as enhance the overall comprehension of the difficulties related to dilatory behavior.


Eligibility Criteria:
Inclusion Criteria:

* Fluent in Swedish
* Computer with Internet access and a working email
* Registered as students at one of the affiliated universities of the Student Health Centre at Karolinska Institutet
* Primary difficulties related to chronic and severe procrastination

Exclusion Criteria:

* Severe depression (30 points or more on MADRS-S)
* Acute conditions in need of treatment; suicidal ideation, neuropsychiatric conditions (ADHD, ADD), misuse of alcohol or drugs, bipolar disorder, schizophrenia, and psychosis
* Ongoing psychotherapy
* Ongoing psychotropic medication (unless dose is stable three months prior the entering treatment)
Synbiotic Dietary Supplement and Gut Microbiota

To test the feasibility and safety of our designer synbiotic on gastrointestinal symptoms and gut microbiota and fecal metabolomics.

This will be a double-blinded, randomized, placebo-controlled paired crossover pilot study in healthy controls aimed to evaluate gastrointestinal tolerance of a synbiotic dietary supplement.

Eligibility Criteria:
Inclusion Criteria:

* BMI 19-25 (lean) and BMI 30-35 (obese)
* Age 18-45 years old
* subjects must be willing to consume oral dietary supplement and placebo daily for a total of 56 days,
* willing to complete gastrointestinal (GI) and dietary surveys, body composition assessment, and provide blood, urine and stool sample at 4 intervals during the pilot study (baseline, after first supplementation period (day 28), after washout period (day 49), and after second supplementation period (day 77)

Exclusion Criteria:

* antibiotic consumption within 28 days of study initiation
* diabetes
* kidney disorders
* history of cardiac disease and medications for cardiac disease
* use of statins and antihypertensive drugs
* inflammatory bowel disease
* irritable bowel syndrome
* history of small intestinal bacterial overgrowth
* history of intestinal surgery, excluding hernia repair and appendectomy
* active cancer diagnosis; chronic acid suppression treatment (proton pump inhibitors, histamine H2 receptor antagonists)
* immune modulatory treatments (e.g. chronic immunosuppressive medications, chronic NSAIDs)
* abnormal liver or kidney function as measured by routine serum chemistry testing
* severe anemia or significant white blood cell or platelet abnormalities
* no additional blood or blood product donations during study
Prospective SPINE Registry

This study is a prospective, multi-center, open label registry designed to collect real-world data on performance and safety data on RTI's spine products.


Eligibility Criteria:
Inclusion Criteria:

1. Candidate for RTI spine product.
2. Willing and able to consent to the study.

Exclusion Criteria:

1. Patient who is, or is expected to be inaccessible for follow-up.
2. Patient meets any exclusion criteria required by local law (e.g. age, mental capacity, etc.).
3. Other concurrent medical or other condition (chronic or acute in nature) that in the opinion of the investigator may prevent participation or otherwise render patient ineligible for the study.
Use of the Shang Ring Circumcision Device in Boys Below 18 Years Old in Kenya

A proof of concept study to evaluate the feasibility of using the Shang Ring, a novel male circumcision device across all childhood age groups namely infants (under 1), 1-5 age group, 6-12 age group and the 13-17 age group. The study will evaluate the safety, efficacy and course of wound healing when using the Shang Ring technique across the four childhood age groups.

A proof of concept study to evaluate the feasibility of using the Shang Ring, a novel male circumcision device across all childhood age groups namely infants (under 1), 1-5 age group, 6-12 age group and the 13-17 age group. The study will evaluate efficacy, procedure time, difficulties during surgery and post-operative events shall be assessed. To evaluate safety, the investigators will clinically observe for adverse events during the course of healing. The investigators will also evaluate to length of time taken for complete healing to be achieved.

Eligibility Criteria:
Inclusion Criteria:

* Must be accompanied by the parent or legally acceptable representative (LAR), who freely consents for participation of the child into the study;
* Assent from participant 7 years of age and above who understand study procedure;
* Aged between 1 month and 17 years(inclusive);
* Body weight of more than 2.5 kgs and penile shaft more than 1 cm in length.
* Must be in good general health;
* Must be free of genital ulcerations or other visible signs of STI (on examination);
* Parent or LAR and if possible the client must be able to understand study procedures and requirements of study participation;
* Parent or LAR must agree to return the client to the study site for the full schedule of follow-up visits after his circumcision;
* Parent or LAR must have a cell phone or access to a cell phone; and,
* Parent or LAR must agree to provide the study staff with an address, phone number, or other locator information while participating in the research study.

Exclusion Criteria:

* Has a known allergy or sensitivity to lidocaine or other local anesthesia;
* Takes a medication that would be a contraindication for elective surgery, such as an anticoagulant or steroid;
* Has known bleeding/clotting disorder (e.g. hemophilia);
* Has any congenital genitourinary abnormality;
* Has an active genital infection, anatomic abnormality or other condition (e.g. severe obesity, diabetes or sickle cell anemia), which in the opinion of the surgeon, prevents the man from undergoing a circumcision as part of this study; or
* Is currently participating in another biomedical research study.
The Role of Dietary Tryptophan on Aryl Hydrocarbon Receptor Activation

This study evaluates the role of dietary L-tryptophan, an essential amino acid, in the activation of a specific cellular component: the aryl hydrocarbon receptor.

The Aryl hydrocarbon receptor (AHR) is a ligand-dependent transcription factor implicated in a range of key cellular events. In the gut, AHR is crucial for maintaining intestinal barrier immune homeostasis. The physiology of the AHR, however, is not completely understood; its precise gut luminal activators and functional consequences are unknown.

Some AHR ligands originate from the diet. Commensals play crucial roles in metabolizing tryptophan and other amino acids such as tyrosine, with the subsequent production of tryptophan metabolites. Previous studies show that inflammatory bowel disease (IBD) patients have impaired production of AHR agonists by the microbiota. Furthermore, dietary supplementation with tryptophan ameliorates clinical parameters of colitis in rodent models. Whether these findings translate into human pathophysiology has not been explored.

In the present study, the investigators will evaluate the effect of high- versus low-tryptophan diet on AHR activation in healthy participants. Briefly, participants will be instructed to follow a standardized low-tryptophan diet and will be randomized to a 3-week L-tryptophan supplement or placebo. Later, after a 2-week washout period, participants will crossover to the other arm. In addition, the effect of tryptophan and microbiota-derived metabolites on AHR activation will be analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteer between 18 and 75 years of age.

Exclusion Criteria:

* Rome IV criteria for any functional gastrointestinal disorder.
Construction of Diagnosis and Treatment System for Primary Vitreoretinal Lymphoma

This study intends to apply for the establishment of research beds, establish a Chinese PVRL research cohort, and carry out a to achieve the following research objectives:

The goal of this prospective observational study is to construct the diagnosis and treatment system for primary vitreoretinal lymphoma（PVRL）. The study is to achieve the following research objectives:

1. To establish a comprehensive diagnostic criteria for PVRL with high diagnostic efficiency and strengthen the PVRL diagnostic system;
2. To establish a standardized treatment pathway for PVRL and evaluate the efficacy and safety of treatment;
3. To screen the prognosis evaluation indicators, and to establish the follow-up process and prognosis evaluation system of PVRL；
4. To explore the pathogenesis of PVRL, specific tumor markers and drug therapeutic targets.


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed PVRL patients admitted to the Ophthalmology or Hematology departments of Peking Union Medical College Hospital from 2022 to 2024;
* 18-75 years old;
* The diagnosis was confirmed by pathology, aqueous humor/vitreous IL-10/IL-6, vitreous flow cytometry and gene rearrangement.;
* HIV-Ab negative;
* Creatinine clearance \> 50ml/min;
* Sign informed consent.

Exclusion Criteria:

* Combined with other tumors;
* Uncontrolled active infections;
* Pregnant or lactating women;
* Antitumor therapy other than the protocol of this study was used.
HARP Mindfulness Study

This study was designed using the Multiphase Optimization Strategy (MOST) framework to determine whether two supplemental components increase the efficacy of a mindfulness-based cognitive therapy program delivered via telephone (MBCT-T) for psychological distress. Specifically, this study will test mindfulness booster sessions to follow a standard 8-week MBCT-T intervention, as well as website support in patients with heart disease and/or heart disease risk factors.


Eligibility Criteria:
Inclusion Criteria:

* Patients meeting one of the following criteria:

  * Has a diagnosis of ischemic heart disease (ICD-10 codes I20 - I25) with no cardiac hospitalizations in the past 6 months
  * Has cardiovascular disease risk factors without meeting a diagnosis of ischemic heart disease or having a cardiovascular disease event (heart attack, stroke, heart failure, and/or unstable angina). Cardiovascular disease risk factors include hypertensive diseases (ICD-10 codes I10 - I11, I15 - I16), diabetes (E8 - E13), and/or hyperlipidemia (E78.0 - E78.5, E78.9)
* Patients meeting one or more of the following criteria at baseline:

  * Elevated stress (PSS-10 score ≥15)
  * Mild to moderate depressive symptoms (PHQ-9 score between 5-14)
  * Mild or greater anxiety (GAD-7 score ≥5)
* Willing to provide informed consent and comply with all aspects of the protocol
* Able to read and communicate in English

Exclusion Criteria:

* Active suicidal ideation
* History of, or current diagnosis of, psychosis
* Significant cognitive impairment (noted in the EHR or evident during screening)
* Significant hearing loss
* Current participation in another behavioral clinical trial
* Has received the MBCT-T intervention in a previous clinical trial.
SARS-CoV-2 Specific Immune Response After COVID-19 Vaccination in Cancer Patients

Our study highlights a low degree of neutralization-afforded protection mounted by CoronaVac in cancer patients when compared with healthy volunteers, especially patients who received chemotherapy. Further booster doses, beyond the conventional two-dose regimen might be needed for recipients of CoronaVac to maintain a long-term anamnestic response.

A total of 311 participants, including 107 patients with solid tumor and 204 healthy volunteers who received 2 doses of CoronaVac were recruited from National Cancer Institute of Thailand between 2020-2021. Blood samples were collected after second dose of CoronaVac for 15 days and the neutralizing antibody (NAb) titers were detected using live-virus neutralization.SARS-CoV-2 antibody positivity was detected in 77 (72%) patients and 199 (97.5%) healthy volunteers. Antibody positivity rate was lowest (67.2%) in patients who received chemotherapy, followed by patients with post-treatment (74.2%) and patients who planned to start treatment (91.7%). Our study highlights a low degree of neutralization-afforded protection mounted by CoronaVac in cancer patients when compared with healthy volunteers, especially patients who received chemotherapy. Further booster doses, heterologous or otherwise, beyond the conventional two-dose regimen might be needed for recipients of CoronaVac to maintain a long-term anamnestic response.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female age at least 18 years
* Patients with a diagnosis of solid tumors
* Ability to understand the patient information and study consent. Signed and dated written informed consent must be available before performing any study-related procedure
* Willing and able to comply with the study procedures.
* Willing to receive a Coronavac vaccine (Sinovac).

Exclusion Criteria:

* Patients who cannot provide consent
Efficacy of Vitamin D Treatment in Pediatric Patients Hospitalized by COVID-19

Open controlled clinical trial. Hospitalized pediatric patients with COVID-19 will be included. Upon admission to hospital serum determination of vitamin D, interleukins, ferritin and Dimer D will be performed. Subsequently, randomization will be performed to identify which group the patient belongs. Adverse effects will be evaluated on a daily basis. Serum levels of interleukin (IL) -2, 6, 7,10, ferritin and dimer-D will be taken at the beginning of hospitalization and on the 7th day after admission. It will be recorded if the patient presents deterioration of the respiratory function that requires endotracheal intubation and / or admission to intensive care and / or if he dies, and at what time of hospitalization does this outcome occur. The study will culminate when the patient is discharged from hospitalization.

Hospitalized pediatric patients with COVID-19 will be included. The diagnosis of COVID-19 performed through RT-PCR. Upon admission to hospital, a serum determination of Vitamin D, interleukins, ferritin and dimer-D will be performed. Subsequently, randomization will be performed to identify which group the patient belongs to. In case of being in the vitamin D group, in children under 12 months they will be given 1000U and in children over 12 months they will be given 2000U every 24 hours orally. Adverse effects will be evaluated on a daily basis. Subsequently, serum levels of interleukin (IL) -2, 6, 7,10, ferritin and dimer-D will be taken on day 7 of admission. It will be recorded if the patient presents deterioration of the respiratory function that requires endotracheal intubation and / or admission to intensive care and / or if he dies, and at what time of hospitalization does this outcome occur. The study will culminate when the patient is discharged from hospitalization. On the day of hospital discharge, a blood sample will be taken to determine vitamin D.

Eligibility Criteria:
Inclusion criteria

1. Age over 1 month and under 17 years
2. Confirmed diagnosis of COVID-19 infection with the results of real-time PCR
3. That they agreed to participate in the study.
4. That the patient tolerates the enteral route

Exclusion criteria

1. Have received vitamin D in the four weeks prior to hospitalization.
Cancer Predictive Score on Breast MRI

Sometimes, breast ultrasound and mammographic can't be diagnose suspsious lesions ( no substratum). So a MRI-guided breast biopsy is perfomed and disclosed ultimately benign lesions.

The aim of this retrospective study is to establish a predictive MRI score of occult breast lesions by mammography and ultrasound.


Eligibility Criteria:
Inclusion criteria:

* women aged 18 and more
* performed MRI-guided breast biopsy

Exclusion criteria:

- Not MRI-guided breast biopsy
Study Comparing the Immune Response of Fluarix and Fluzone Influenza Vaccines

The purpose of this study is to compare two licensed influenza vaccines (Fluzone and Fluarix) in terms of the immune response elicited and the safety/ any symptoms that may occur for up to six months after vaccination.

* Experimental design: multi-center, randomized (1:1), observer-blind, active-controlled study in 2 parallel groups with approximately:
* Study vaccine: full dose of Fluarix by IM administration.
* Control vaccine: full dose of Fluzone by IM administration.
* Two scheduled visits per subject at days 0 (visit 1) and 21(visit 2) with blood sample collected at each visit to evaluate the immune response. There will be a final contact with each subject 6 months after vaccination for safety follow up and study conclusion.
* Vaccination schedule: one IM injection at day 0.
* Type of study: Self contained.

Eligibility Criteria:
Inclusion Criteria:

* All adults 18 years and older.
* Subjects who the investigator believes can and will comply with the requirements of the protocol (e.g., return for follow-up visit and completion of the diary cards) should be enrolled in the study.
* Written informed consent obtained from the subject.
* If the subject is female, she must be of non-childbearing potential, i.e. either surgically sterilized or one year post-menopausal; or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions .

Exclusion Criteria:

* Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the administration of the study vaccine, or planned use during the study period.
* Has received any other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrollment in this study.
* History of hypersensitivity to a previous dose of influenza vaccine.
* History of allergy or reactions likely to be exacerbated by any component of the vaccine(s) including egg, chicken protein, gelatine, formaldehyde, gentamicin sulphate, thimerosal or sodium deoxycholate.
* Acute disease at the time of enrollment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhea, mild upper respiratory infection with or without low-grade febrile illness, i.e. Oral temperature \<37.5°C (99.5°F) / Axillary temperature \<37.5°C (99.5°F)).
* History of Guillain Barré syndrome within 6 weeks of prior receipt of inactivated influenza virus vaccine.
* Pregnancy and lactating females.