cyrilzakka/clinical-trials huggingface dataset:
Vitamin K Injections for the Treatment of Painful Menstruation

The purpose of this study is to test the feasibility and effectiveness of vitamin K injections into certain body parts for the treatment of painful menstruation.

Painful menstruation, also known as dysmenorrhea, is a common problem affecting a significant percentage of women. In the United States and Europe, nonsteroidal anti-inflammatory drugs (NSAIDs) and oral contraceptives are the most commonly prescribed treatments for this condition. However, in China, oral contraceptives are not commonly prescribed for unmarried women. Acu-injection, a procedure involving the injection of vitamin K into acupuncture points, has become standard treatment for dysmenorrhea at many Chinese health care facilities. This trial will assess the willingness of young Chinese women to participate in an acu-injection trial, explore the utility of pain measurements after injection, and determine the effectiveness of the injections. This study will also help in planning larger acu-injection clinical trials.

This study will last for five menstrual cycles. Participants will be randomly assigned to one of three groups. Group 1 participants will receive a vitamin K3 injection in an acupuncture point of both legs and a saline injection in the right buttock. Group 2 participants will receive a saline injection in an acupuncture point of both legs and a saline injection in the right buttock. Group 3 participants will receive a saline injection in a pseudo-acupuncture point of both legs and a vitamin K3 injection in the right buttock. Injections will be administered one time during the first 2 days of the first menstrual cycle for participants who are experiencing menstrual pain. Participants will record their level of menstrual pain before injection and at 2, 5, 30 and 60 minutes after the injections. Participants who do not respond to or are not satisfied with the acu-injection treatment will be offered either Chinese herbal medicine or NSAIDs within 1 hour of the injection. After the injection visit, participants will be asked to complete questionnaires about any menstrual pain or side effects they may be experiencing for five subsequent menstrual cycles.

Eligibility Criteria:
Inclusion Criteria:

* Dysmenorrhea for at least 6 months prior to study entry
* Have never been pregnant or have given birth
* Mandarin Chinese or Shanghainese speaking
* Regular menstrual cycles for at least 6 months prior to diagnosis of dysmenorrhea
* Has a working home phone or cellular phone
* Willing to disclose address
* Intends to stay in the area during the study
* Parent or guardian willing to provide informed consent, if applicable

Exclusion Criteria:

* Dysmenorrhea due to any suspected or recognized causes
* Current use of hormonal contraceptives or an intrauterine device
* History of abdominal surgery
* Other concomitant therapy for acute or chronic pain
* Anticoagulant drugs
* Vitamin K acu-injections at leg acupuncture points prior to study entry
* Intolerance to NSAIDs
* Known allergy to vitamin K
Influenza Vaccine in Lung Transplant Patients - Seroprotection

This a sub-study of a 5-year study designed to investigate how antibody and T cell responses following influenza vaccine compare among lung transplant patients, patients waiting for lung transplantation, and healthy individuals.

This study is designed to investigate two different definitions of influenza vaccine seroprotection at mid-season in lung transplant patients.

Given the significant risk of morbidity and mortality, it is critical and highly recommended that lung transplant patients receive annual influenza immunizations that confer protection throughout the influenza season. Previous studies have demonstrated that transplant recipients and nonimmunocompromised populations display similar rates of seroprotection between 3 and 5 weeks after influenza vaccination, despite the transplant population achieving generally lower antibody concentrations. Two studies show influenza vaccine antibody persistence at reasonable rates at 1 year, but not 2 years, after immunization. However, there are no studies comparing seroprotection rates 6 months after vaccination, reflecting adequate coverage throughout the entire influenza season.

Seroprotection has traditionally been defined as an antibody concentration of at least 40 hemagglutination units (HAU) after vaccination, which is the criterion for influenza vaccine licensure. This concentration of antibody provides protection from infection at a rate of about 50% in typically healthy individuals. Protection from infection improves with higher antibody concentrations. For this study, a HAU of at least 160 was selected as a more conservative definition of seroprotection, where protection may reach up to 95%.

The hypothesis is that seroprotection, defined as 40 HAU or greater, will persist up to 6 months at high rates in lung transplant patients and that these rates will be comparable to the rates in healthy individuals. As a secondary outcome, seroprotection rates are compared when 160 HAU or greater was used to define seroprotection.

Influenza vaccine responses in lung transplant patients and healthy control subjects without lung disease will be compared over the course of the 2008 to 2009 influenza season.

Serum collected from participants before immunization, 2 to 4 weeks after immunization (postimmunization), and 6 months after immunization.

\[This substudy that was originally registered to NCT00205270 and subsequently registered to its own NCT number for the purpose of clarity in linked results\]

Eligibility Criteria:
Inclusion Criteria:

* Receiving care post-lung transplant at University of Wisconsin Hospital
* Healthy adult

Exclusion Criteria:

* Allergy to eggs
* Moderate to severe febrile illness
* Active treatment for acute rejection
* Received season's influenza vaccine prior to enrollment
Risk and Incidence of Aortic Graft and Endograft Infection With BSI

What is the risk of aortic vascular graft and endograft infection in patients with aortic vascular graft/endograft and bloodstream infection?

All patients with previous aortic vascular graft and endograft surgery between years 2010 and 2021 in four regions of south Sweden (Skåne, Halland, Kronoberg and Blekinge) will be included in the study. These patients will be evaluated for bloodstream infection (BSI) or not. For all patients with BSI, the risk of aortic vascular graft and endograft infection will be investigated. Aortic vascular graft and endograft infection will be determined by usage of the MAGIC-criteria.

Risk factors for developing aortic vascular graft and endograft infection will be investigated, and if possible used to construct a risk score. This risk score could be used by clinicians to determine if bacteremic patients with aortic vascular grafts or endografts should be evaluated for aortic vascular graft and endograft infection.

Eligibility Criteria:
Inclusion Criteria:

Previous aortic vascular graft or endograft infection with bloodstream infection.

Exclusion Criteria:

-
Prospective, Open-label Study of Seraph 100 in Patients With Prolonged COVID (PC)

This study will use a prospective, open, single-arm design, in which a group of 100 patients with a diagnosis of prolonged COVID, previously selected according to inclusion and exclusion criteria, and who have undergone informed consent process and have signed the informed consent form, undergo two hemoperfusion procedures with the Seraph 100 filter, on consecutive days. They are then evaluated at day 3 and 4 weeks, to complete the safety and effectiveness assessment.

This will be a prospective, open-label, single-arm, pilot study, in which a group of 100 PC patients will undergo two hemoperfusion procedures, to verify the safety and preliminary efficacy of the Seraph 100 device. Eligible patients will be invited to participate and once they sign the Informed Consent (IC) they will undergo two hemoperfusion procedures, on consecutive days, of -4 hours duration each time, using a multicomponent apheresis machine with the Seraph 100 filter. Patients will be followed for a total of 30 days, to monitor the presence of AEs (safety) and possible changes in clinical outcomes (preliminary efficacy).

Eligibility Criteria:
Inclusion Criteria:

Subjects will be considered eligible for participation in the study if they meet all the following inclusion criteria:

1. Adult patients age of 18-85 (had 18th birthday but did not have 85th birthday).
2. History of COVID 19 infection established by positive polymerase chain reaction (PCR) test or by compatible clinical testing (e.g. rapid antigen, serum testing, or other relevant clinical documentation).
3. Persistent symptoms for 12 or more weeks after acute COVID 19 infection including fatigue and one or more of the following: myalgia or generalized aches and pains; joint pain; dizziness or unsteadiness; cognitive dysfunction (mental fog).
4. Patient (legally designated representative) has completed the Informed Consent process prior to enrollment into this study.
5. Patient (legally designated representative) is willing to comply with the study protocol -

Exclusion Criteria:

Subjects meeting any of the following criteria will not be recruited for the study:

1. History of heparin allergy.
2. History of heparin-induced thrombocytopenia.
3. Pregnancy or breastfeeding.
4. Life expectancy is less than 30 days.
5. The patient is currently enrolled in another drug or device trial. Patients who cannot tolerate placement of double-lumen catheter.
6. Unable to obtain informed consent from either patient or legally authorized representative (LAR)Any subject who, in the investigator's judgment, is considered unsuitable for participation in this trial.

After verification of eligibility and signature of consent:

1. The patient must be able to perform a hemoperfusion procedure with an apheresis machine.
Lipid-Lowering Effect and Hypotensive Effect of Shanzha Fruit Drink in Patients

This is a single-center, randomized, double-blind, placebo-controlled, cross-over study. Subjects who meet the inclusion/exclusion criteria will be randomly and alternatively assigned to receive Shanzha fruit drink or placebo drink in the first 2 months or the last two months of the 5 months study period. In between the first and second treatment period, all patients will enter a Washout Period of 4 weeks and during which time patients should not receive any of the study functional fruit drink.


Eligibility Criteria:
Inclusion Criteria:

* • Total Cholesterol between 200-300 mg/dl (5.2-7.8 mmol/l).

  * Mean plasma triglyceride \>= 4.5 mmol/l.
  * Diastolic blood pressure 95-100 mm Hg and/or Systolic blood pressure 130-150 mm Hg.
  * Be able to give written informed consent prior to study start and comply with study requirements.

Exclusion Criteria:

* • Total Cholesterol between 200-300 mg/dl (5.2-7.8 mmol/l).

  * Mean plasma triglyceride \< 4.5 mmol/l.
  * Diastolic blood pressure 95-100 mm Hg and/or Systolic blood pressure 130-150 mm Hg.
  * Be able to give written informed consent prior to study start and comply with study requirements.
Psychological Interventions in Siblings of Children With Cancer

The purpose of the study is to evaluate the effectiveness of a two-session brief psychological intervention in siblings of pediatric cancer patients with regard to behavior problems and depression.

Within a randomized controlled design the effects of a brief two-session psychological intervention (child, parents) shall be studied in 30 siblings of newly diagnosed pediatric cancer patients. After a baseline assessment 3-4 weeks after diagnosis participants are randomly assigned to an intervention or waiting list group. Both are re-assessed at 3 and 6 months by means of standardized questionnaires assessing psychological adaptation and behavior. The intervention is provided to the waiting list group after the 6-month assessment.

Eligibility Criteria:
Inclusion Criteria:

brother or sister with newly diagnosed cancer treated at the University Children's Hospital command of the German language normal developmental level

Exclusion Criteria:
A Study to Evaluate the Efficacy and Safety of ALH-L1005 in Patients With Chronic Periodontitis

The main objective of this study is to evaluate efficacy and safety of ALH-L1005 in patients with chronic periodontitis


Eligibility Criteria:
Inclusion Criteria:

* Men or women ages 18 and over, under 79 years of age
* Patients diagnosed with chronic periodontitis
* Patients with 4 teeth and over whose pocket depth is ≥ 4 mm and clinical attachment level is ≥ 3 mm
* Patients who are voluntarily participated in clinical trial

Exclusion Criteria:

* History of antibiotic therapy within the 1 month prior to study
* Those who had undergone any dental surgical or non-surgical therapy within 3 months prior to the start of the study
* Subjects who are pregnant/ lactating
* Smokers
* Patients who take Anticoagulants or Antiplatelet Agents
* With Systemic diseases that affect periodontal conditions such as: diabetes, hypertension and diseases of immune system
Mindfulness Training in Adults With ADHD

The primary aim of this study is to investigate clinical effectiveness of mindfulness training versus treatment as usual (TAU) in adults with Attention Deficit Hyperactivity Disorder (ADHD). The secondary aim is to assess whether mindfulness training is cost-effective compared to TAU in adults with ADHD from a societal perspective.

RATIONALE Attention Deficit Hyperactivity Disorder (ADHD) is a common neurodevelopmental disorder with a high persistence into adulthood. Patients with ADHD are primarily offered stimulant medication. However, not all patients are willing to take medication, some suffer from unacceptable side-effects and for many medication does not reduce their symptoms to the degree they would wish for. Therefore, there is a strong need for effective psychosocial interventions that are both accessible to a large group of patients and have been shown to be cost-effective, such as mindfulness training.

OBJECTIVE To examine the (cost)effectiveness of mindfulness versus treatment as usual (TAU) in adults with Attention Deficit Hyperactivity Disorder (ADHD).

HYPOTHESIS Mindfulness training will result in less ADHD symptoms, a better executive functioning, a better quality of life, and lower health care and societal costs.

STUDY DESIGN Randomised trial comparing mindfulness in addition to TAU with TAU alone. Baseline, end of treatment, follow-up 1 (6 months after baseline) and follow-up 2 (9 months after baseline) assessments will be done by blinded assessors and self-report questionnaires. After 9 months, patients allocated to the TAU condition will be offered mindfulness as well.

STUDY POPULATION N=120 adults with ADHD according to the DSM-5 using a structured psychiatric interview, referred to Radboudumc in Nijmegen, Reinier van Arkel in 's Hertogenbosch and Dimence in Deventer.

INTERVENTION The investigators have developed a treatment protocol of mindfulness for ADHD based on both the Mindfulness-Based Cognitive Therapy (MBCT) (Segal, Williams \& Teasdale, 2013) and the mindfulness training for ADHD developed by Zylowska (2012).

STANDARD INTERVENTION TO BE COMPARED TO Treatment as usual, usually consisting of psychostimulants and psycho-education.

COST-EFFECTIVENESS ANALYSIS/ BUDGET IMPACT ANALYSIS Annual health care and societal cost savings are expected to be €1,2 million and €15,4 million, respectively.

Eligibility Criteria:
Inclusion Criteria:

The investigators will include patients of 18 years and older who meet the following criteria:

* a primary diagnosis of ADHD, according to the criteria of Diagnostic and Statistical Manual of Mental Disorders - 4th edition (DSM-IV-TR) based on a structured Diagnostic Interview for ADHD, in adults (DIVA)
* capable of filling out questionnaires in Dutch

Exclusion Criteria:

* depressive disorder with psychotic symptoms or suicidality
* active manic episode
* borderline or antisocial personality disorder
* substance dependence
* autism spectrum disorder
* tic disorder with vocal tics
* learning difficulties or other cognitive impairments
* former participation in a MBCT or MBSR course
Mecapegfilgrastim for the Prevention of Dalpiciclib -Induced Neutropenia in Advanced Breast Cancer

Neutropenia is a common complication from dalpiciclib. Mecapegfilgramtim (code name HHPG-19K), a long-acting recombinant human granulocyte colony-stimulating factor (rhG-CSF), has been developed. The study aim to evaluate the safety and efficiency of mecapegfilgrastim for prophylaxis of dalpiciclib -induced neutropenia in patients with advanced HR+/HER2- breast cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18.
2. Pathologically confirmed advanced HR+/HER2- breast cancer: there is evidence of focal recurrence or metastasis, which is not suitable for surgical resection or radiotherapy for the purpose of cure.
3. No more than one line of chemotherapy is allowed for patients with recurrent and metastatic diseases.
4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
5. Measurable lesions meeting RECIST 1.1 criteria or only bone metastases.
6. For patients with brain metastases, there is need for local treatment, and the brain lesions are stable for ≥ 3 months, and no need for dexamethasone or mannitol.
7. Adequate organ function: (I) adequate hematologic function: hemoglobin ≥90 g/L, absolute neutrophil count (ANC) ≥2.0×109/L, platelet count (PLT) ≥100×109/L; (II) adequate renal and hepatic function.
8. Negative pregnancy test.

Exclusion Criteria:

1. Previous pathological diagnosis of HER2 positive breast cancer.
2. Relapse and metastasis occurred after receiving neoadjuvant endocrine therapy or adjuvant therapy for 2 years, or disease progression or recurrence occurred within 12 months or 12 months after completion of adjuvant endocrine therapy.
3. Previous treatment with cdk4/6 inhibitors.
4. Major surgery, chemotherapy, radiotherapy, any research drug or other anti-cancer treatment within 2 weeks before entering the trial.
5. Any other malignant tumor diagnosed within 3 years before entering the study, except non-melanoma skin cancer, basal cell or squamous cell skin cancer or cervical carcinoma in situ after radical treatment.
6. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), active hepatitis B (HBV DNA ≥ 1000 IU/ml), hepatitis C (HCV antibody positive and HCV-RNA higher than the detection limit of the analytical method) or combined hepatitis B and hepatitis C co-infection.
7. Within 6 months before entering the study, the following conditions occurred: myocardial infarction, severe / unstable angina pectoris, NYHA grade 2 or above cardiac insufficiency, persistent arrhythmia ≥ grade 2 (according to nci-ctcae version 5.0), atrial fibrillation at any level, coronary / peripheral artery bypass grafting, symptomatic congestive heart failure, cerebrovascular accident (including transient ischemic attack or symptomatic pulmonary embolism).
8. Inability to swallow, intestinal obstruction or other factors affecting drug administration and absorption.
Performance Value of Research of Occult Gastrointestinal Bleeding by Immunoassay in the Diagnostic Process of Iron Deficiency Anemia in Patients Over 75 Years

This study aims to characterize the diagnostic performance of immunological testing of occult gastrointestinal bleeding in stool in the population aged over 75 years with iron deficiency anemia.

As secondary objectives, the study aims to:

* determine a threshold of positivity optimizing the immunoassay performance for the study population, in accordance with the probabilities of error (false positives, false negatives) and weights (defined by expert consensus) allocated to these errors.
* Assess the benefit of a double measure of bleeding (two stools) by immunoassay compared to a single measure.

Immunological testing will be performed systematically for each patient.

Research of blood in fecal sample will be based on 2 methods: one based on a qualitative immunochromatographic method (such as HemSign4 technique, Servibio, France; or all other techniques used at AP-HP) and another quantitative immunoturbidimetric method (OC-Sensor, Eiken, Japan). They will be performed systematically with two fresh fecal samples for each patient, before coloscopy examination.

Treating physicians will not be provided with the testing result. The diagnosis of reference will be established by experts based on the result of explorations (colonoscopy, coloscanner) and the patient's progression, blinded to the result of immunoassay.

The intrinsic characteristics of the immunoassay (sensitivity, specificity...) will be determined with reference to this reference diagnosis, using a positivity threshold defined using expert consensus on the weights to be allocated to potential errors.

2 modeling scenarios (without vs with immunological testing) using decision trees based on prevalence and diagnostic performance observed and stochastic simulations.

Eligibility Criteria:
Inclusion Criteria:

* Physical status score 3 or 4, aged 75 and older patient, (patients under guardianship may be included).
* Iron deficiency anemia (Hb≤120 g/l for a woman or Hb≤130 g/l for a man), and nonregenerative anemia with reticulocytes \<120 000/mm3.
* Patient who has indication for colonoscopy and / or colonography examination, whatever the results of gastroscopy if performed.
* Have a health insurance.
* Informed consent signed.

Exclusion Criteria:

* Hematemesis or melena
* Life expectancy inferior to 12 months
* Patient has difficulty in follow-up of study.
Efficacy 2 Part Study of Identification of Keloid Biomarkers and Effect of QAX576 on Keloid Recurrence

This is a 2-part study. In the first part (Part I, 8 subjects), biopsies will be obtained from the resection site after keloid shaving and two weeks following resection to assess and select biomarkers to determine the biologic effects that occur in shaved keloids. No drug will be administered.

In Part II (32 patients) will be randomized to receive QAX576 or placebo. An initial drug infusion will be followed by shave removal of keloids 6 - 8 days later followed by two additional drug infusions 4 weeks apart. Two weeks following resection, punch biopsies will be performed to assess biomarker responses. Patients will be followed-up for 52 weeks after first drug administration to assess keloid recurrence (clinically and by 3D imaging), and by physician's and patient's cosmetic assessments, and safety.


Eligibility Criteria:
Inclusion Criteria:

- Patients with two or more keloids on the trunk, upper extremities or thighs. The keloids must meet specified size criteria and have been present for greater than or equal to 1 year, been stable in size and symptoms for at least 6 months.

Exclusion Criteria:

* Use of other investigational drugs at the time of enrollment, or history of hypersensitivity to any of the study drugs or to drugs of similar chemical classes (e.g. lidocaine, epinephrine, and topical antibiotics as bacitracin and neomycin).
* History of repeated recurrence of keloid after prior surgical removal (4-5 times removed).
* Keloids near the hands, joints, and anogenital areas as recurrence might cause significant problems.
* Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the patient in case of participation in the study

Other protocol-defined inclusion/exclusion criteria may apply.