cyrilzakka/clinical-trials huggingface dataset:
Multi-centre Study to Assess the Long-term Performance of the Deltamotion Cup System in Primary Hip Replacement Surgery

The purpose of this study is to monitor the performance of the DeltaMotion cup system in the treatment of patients with hip joint disease requiring a total hip replacement.Patients who enter the study will be evaluated at regular intervals following hip surgery using patient, clinical and x-ray assessments.


Eligibility Criteria:
Inclusion Criteria

i) Male or female subjects, aged between 18 and 70 years inclusive.

ii) Subjects who are able to give voluntary, written informed consent to participate in this Clinical Investigation and from whom consent has been obtained.

iii) Subjects who, in the opinion of the Investigator, are able to understand this Clinical Investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups.

iv) Subjects suitable for a cementless total hip replacement using the DeltaMotion Cup System, in accordance with all applicable Instructions For Use

Exclusion Criteria

i) Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this Clinical Investigation.

ii) Women who are pregnant.

iii) Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes.

iv) Subjects who have participated in a Clinical Investigation with an investigational product in the last 12 months.

v) Subjects who are currently involved in any injury litigation claims.
Study of Comprehensive Diagnosis and Treatment for Children Precocious Puberty

This is a prospective, multicentric, comparative, non-randomized interventional study in which subjects diagnosed with central precocious puberty (CPP) and early puberty (EP) were treated for 6 months to compare the effect with GnRHa and traditional Chinese medicines.

740 girls with CPP and EP participated in this study, all participates were divided into GnRHa group, traditional chinese medicines group and blank group. After at least six months therapy with GnRHa or traditional Chinese medicines, the investigators compare clinical parameters, sex hormone, bone age and ovarian ultrasound in three groups.

Eligibility Criteria:
Inclusion Criteria:

1. Premature appearance of secondary sexual characteristics: girls present with development of secondary sexual characteristics before 8, with breast induration as the earliest manifestation.
2. Accelerated linear growth: the annual growth rate is higher than normal.
3. Advanced bone age: the bone age is 1 or years more than the actual age
4. Enlargement of sexual glands: B-mode ultrasonography of pelvic cavity indicates the volumes of the uterus and ovaries have increased, and multiple ovarian follicles with a diameter\>4mm can be found in ovaries;
5. HPGA functions have been primed; serum gonadotropin and sexual hormone levels reach pubertal values.
6. Subjects should be willing and able to follow the study protocol during the study period.
7. Subjects should submit their parents' or guardians' written informed consent before initiation of the study procedure with non-normal medical care. They should understand that subjects or their parents/guardians may withdraw the consent at any time without impairing future medical care. If the child is old enough to read and write, she should submit a separate consent form.

Exclusion Criteria:

1. Patients with central nervous system diseases and thyroid diseases;
2. Patients with CHA-induced precocious puberty;
3. Patients with poor compliance.
Healthcare-associated Links in Transmission of Nontuberculous Mycobacteria in Cystic Fibrosis

Sources of NTM infection and modes of transmission among CF patients are poorly understood. Healthcare-associated transmission of NTM among CF patients has been suspected and is of growing concern for CF Centers. There is a need for a systematic evidence-based approach to investigating potential episodes of healthcare-associated transmission. Clusters of highly similar strains of NTM in CF patients cared for at the same CF Center may arise from healthcare sources including patient-to-patient transmission and/or acquisition from water sources within a healthcare setting. The primary objective of the study is to facilitate a standardized process by which CF Centers may perform data abstraction on patients identified with highly similar NTM isolates and determine if clustered NTM strains are related to strains isolated from healthcare setting water biofilm sources. HALT NTM is available to the entire CF Foundation Care Network, under a collaborative agreement, to initiate a standardized, independent, confidential, internal NTM outbreak investigation. Patients that are identified by whole genome sequencing as having highly similar NTM strains and receiving care in the same CF Care Center are eligible. The study's primary endpoint is to identify potential modes and sources of healthcare-associated acquisition of CF NTM, thereby revealing risk factors for NTM acquisition.


Eligibility Criteria:
Inclusion Criteria:

* Participants with cystic fibrosis and respiratory NTM growth on one or more occasions

Exclusion Criteria:

* Participants without cystic fibrosis
* Participants without pulmonary NTM growth
WhatsApp Intervention to Assess the Effect of Messages in Adherence to Antiretrovirals in Young People with HIV in Peru

The goal of this clinical trial is to learn which type of messages is more efficacious to improve adherence to medication in young people living with HIV. The main question is aims to answer is:

-Are messages designed by participants (self-designed) more efficacious than messages designed by health providers to improve adherence to antiretroviral treatment (HIV medications)?

Researchers will compare both types of messages to see if one is better than the other in helping participants take their medications.

Participants will:

* Receive either messages designed by themselves or by health providers for 4 months.
* Be able to chat with health providers at any time, with special focus regarding questions about their condition, medications and health services.
* Complete questionnaires via WhatsApp describing how they are taking their medications, and how often they forget to take them.
* Complete questionnaires via WhatsApp describing their opinion about receiving the messages and being able to chat with health providers.


Eligibility Criteria:
Inclusion Criteria:

* People living with HIV of age 18-29 at the moment of signing informed consent.
* Being a patient of the study center's Infectious Diseases clinic or National HIV Program, between March 2024 and July 2024.
* Ownership of a mobile phone that supports WhatsApp.

Exclusion Criteria:

* Being pregnant at the moment of signing informed consent.
* Being illiterate at the moment of signing informed consent.
* Being blind at the moment of signing informed consent
Assessing the Benefit of Art & Music Therapy on Quality of Life in Patients With Breast Cancer

This is a study of art-based and music-based therapy programs lasting three months (with additional follow-up 3 months after the end of the trial) in breast cancer patients currently receiving therapy as well as in cancer survivors.

A cancer diagnosis is often associated with adverse psychosocial effects, including: increased stress and anxiety, fatigue and sleep disturbance, impaired memory and cognition, and poor quality of life. Chemotherapy can cause a cognitive decline in up to 75% of patients; an impairment that oftentimes persists beyond completion of the regimen. This is known as "chemobrain". Integrative therapies are actively being investigated to help improve psychological wellbeing among cancer patients and survivors.

The current standard at this institution is to inform patients of different complementary services that are available, including art therapy, music therapy or acupuncture, but not require patients to use them.

Participants in this study will be randomized to one of three arms 1) Art therapy program, 2) Music therapy program, or 3) Standard of care (SOC). In-person and at-home therapy sessions will be scheduled in alternating, weekly sessions, to allow one week of self-reflection and remote therapy between in-person sessions. Each participant will be asked to attend two in-person therapy sessions per month (total of 6).

The primary objective of this study is to determine the efficacy of a 3-month, therapist-led art or music therapy program to improve quality of life in breast cancer patients currently receiving therapy and in cancer survivors.

Secondary objectives of this study are:

To determine the effect of these programs on patient cognition in this population.

To determine the effect of these programs symptoms of anxiety and depression in this population.

To assess whether the effect of these programs is sustained at a 3-month follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Breast cancer diagnosis (stage 0-III)
* Treated at Cleveland Clinic by medical oncologist, radiation oncologist, and/or breast surgeon Patients currently undergoing treatment or have completed active treatment (surgery, radiation or chemotherapy) within past 5 years.
* Able and willing to participate in art or music therapy programs at Maroone Cancer Center
* Subjects must have the ability to understand and the willingness to sign a written informed consent document
* Ability to read and write in English
* Performance status 0 or 1 as per ECOG scale

Exclusion Criteria:

* No prior history of breast cancer
* History of metastatic disease (Stage IV)
* Not being followed by medical oncologist, radiation oncologist, and/or breast surgeon at Cleveland Clinic
* Unable or unwilling to participate in art or music therapy program at Maroone Cancer Center
Community Level Primary Prevention of Dating and Sexual Violence in Middle Schools

Dating and sexual violence are significant public health concerns occurring on a continuum of severity across the lifespan, with serious consequences to victims and society. The present research advances the science of prevention by rigorously evaluating a comprehensive social norms marketing campaign to promote community-level change in dating and sexual violence in middle schools. Partnership between researchers and a CDC Rape Prevention and Education Program (RPE) funded agency is a core feature of this work, and aims to build community capacity to implement and evaluate violence prevention efforts, and promote the subsequent uptake of social norms marketing campaigns as a strategy for reducing dating and sexual violence among youth.

In a group cluster trial, a comprehensive, tailored, data-based social norms marketing campaign that addresses misperceptions of: 1) the acceptability of dating and sexual violence; 2) gender roles; 3) sexual activity; 4) sexual communication/consent; 5) support for victims; and 6) bystander intervention will be evaluated among middle schools. Poster messaging will be paired with several systematic efforts to diffuse program content through the community, including a Lunch and Learn Teacher Training, Social Norms Video, Teacher Workbook, Parent Mailing, and Parent Information Session. A member of the researcher-practitioner team, designated as a School Resource Provider, will oversee campaign implementation in partnership with a teacher champion. The Resource Provider will also track campaign intensity, assess campaign credibility through intercept interviews with teachers and students, work with teachers to infuse messaging into classroom activities, and assist the teacher champion with addressing "kick-back" to the campaign. Outcome assessments will be completed by teachers, administrators and students. Towards the goal of exploring the role of other environmental factors as moderators of program effects, school administrators will assess their community readiness to develop and implement school dating and sexual violence prevention policy, in general, and social norms marketing, in particular. A neighborhood scan will also be conducted to estimate the density of nearby outlets associated with gender-based personal violence.

Eligibility Criteria:
Inclusion Criteria:

* Student at a middle school or teacher/administrator at a middle school
* Provide student assent and parental consent as specified in protocol or provide adult consent for study participation

Exclusion Criteria:

• None
Postoperative Prognosis Management Service Based mHealth for Prostate Cancer Patients

Recently, the use of mobile health is increasing for the purpose of managing prognosis such as recurrence, survival and quality of life by using a wearable smart band and a smartphone application. In the era of the 4th revolution, mobile health for the purpose of comprehensive prognosis for cancer patients is becoming a very good tool.

It is possible to confirm the clinical significance of short-term and temporary health care through a mobile application and a smart band during the treatment process for cancer patients, but the study is insufficient to generalize the number of subjects.

Therefore, for prostate cancer patients who need prognosis management after surgery, we will investigate the effect of a mobile application using a smart band which has a modular structure reflecting the treatment method and treatment process after surgery.

This study targets patients who underwent prostate cancer surgery. An intervention group (App+IoT device) uses a smart care application for 12 months. This application was tailored for prostate cancer patients and created by reflecting the treatment process after surgery. And they also uses a wearable smart band for 12 months. Control group is provided general education through the hospital brochure. Evaluation will be conducted 2-3days after surgery (before discharge), and at 1, 3, 6, and 12 months after surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients 19 years of age or older who have been diagnosed with prostate cancer
* Patients who have completed surgical treatment for cancer within 3 months of screening and have no additional treatment planned
* Patients who can use a prognosis management application and can perform regular follow-up examinations in outpatient settings
* Patients carrying an Android or iOS smartphone
* Patients who voluntarily decide to participate and give written consent after hearing detailed explanations about this study

Exclusion Criteria:

* Patients who have been treated within the last 3 months for other serious diseases (hematologic cancer, malignancy, etc.)
* Patients for whom additional treatment was planned due to cancer recurrence or metastasis
* Patients with severe cardiopulmonary disease who are unable to proceed with rehabilitation exercise programs
* Patients who find it difficult to proceed with the rehabilitation exercise program due to pain caused by bone metastasis and concerns about pathological fractures
* Patients who underwent lower extremity artificial joint TKRA and THRA
* Patients who are not eligible for rehabilitation exercise as judged by medical personnel
The Impact of Multi-Touch Functional Digital Game on Intelligence and Vitality for the Community-dwelling Elderly

This single-blinded, randomized, controlled trial includes 32 elderly. The participants were randomized to intervention(Happy Table) and control(cognitive stimulation activity) groups. Each group is divided in 16 participants. In one session, participants in the Happy Table group completed 40 minutes of intervention using Happy Table serious game, whereas those in the Control group completed 40 minutes of cognitive stimulation game.

At the first visit, the subjects are fully informed of the study if appropriate after determining whether they meet the selection criteria. This single-blinded, randomized, controlled trial includes 32 elderly. The participants were randomized to intervention(Happy Table) and control(cognitive stimulation activity) groups. Each group is divided in 16 participants. In one session, participants in the Happy Table group completed 40 minutes of intervention using Happy Table serious game, whereas those in the Control group completed 40 minutes of cognitive stimulation game.

Eligibility Criteria:
Inclusion Criteria:

* community-dwelling senior citizens aged 65 to 84
* Those without a history of central nervous system(CNS) disease

Exclusion Criteria:

* When it is difficult to understand the task performance due to severe cognitive decline(Korean Simple Mental State Test, K-MMSE 10 points or less).
* When it is difficult to use this game device due to problems such as decreased vision or fracture of the upper limb
* In case of accompanying serious mental illness
Study of Genes and Environment in Patients With Cancer in East Anglia, Trent, or West Midlands Regions of the United Kingdom

RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This study is looking at genetic susceptibility to cancer and interactions between genes and the environment in patients with cancer in East Anglia, Trent, or West Midlands of the United Kingdom.

OBJECTIVES:

* To obtain epidemiological information and biological material on a population-based series of cancer cases, including malignant melanoma, lymphoma, bladder, kidney, esophageal, and pancreatic cancer, and brain tumors.
* Identify novel cancer susceptibility genes, by comparison of genotype frequencies in cases with the corresponding frequencies in large control series.
* To estimate the age and sex-specific risks associated with variants in predisposition genes.
* To evaluate interactions between polymorphisms in predisposition genes and potential lifestyle risk factors.

OUTLINE: This is a multicenter study.

Patients complete a detailed epidemiological questionnaire that includes information on education, occupation, smoking habits, alcohol consumption, height, weight, reproductive history (age at menarche, age at pregnancies, parity, and age at menopause), oral contraceptive use, hormone replacement therapy use, family history of cancer, and past medical history.

Blood samples are collected from patients. DNA is extracted from these blood samples, from samples collected from cancer-free control participants in MREC-SEARCH-CONTROL, and from additional controls through the European Prospective Investigation of Cancer (EPIC) study (a population-based study of diet and health based in Norfolk, East Anglia). DNA samples are analyzed for polymorphisms of low penetrance cancer susceptibility genes.

In addition to the cancer patients recruited for this study, patients with breast, ovarian, endometrial, colorectal, and prostate cancer are recruited for the following related clinical trials: MREC-SEARCH-BREAST, MREC-SEARCH-OVARIAN, MREC-SEARCH-ENDOMETRIAL, MREC-SEARCH-COLORECTAL, and MREC-SEARCH-PROSTATE.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosed with bladder cancer, kidney cancer, esophageal cancer, pancreatic cancer, brain cancer, malignant melanoma, or lymphoma within the past 5 years
* Identified through the Cancer Research Network OR through the cancer registry serving any of the following geographic regions of the United Kingdom:

  * East Anglia
  * West Midlands
  * Trent

PATIENT CHARACTERISTICS:

* Identified by the patient's general practitioner as fit to contact for this study
* No serious mental illness or retardation

PRIOR CONCURRENT THERAPY:

* Not specified
Comparing Different Routes and Doses of Phytonadione (Vitamin K) for Reversing Warfarin Treated Patients With Hip Fracture Before Surgery

It is well known that femoral neck fractures carry a significant increase in patients' mortality and that surgical intervention is the preferred treatment.

Any delay in operating on such patients would inevitably increase their risk of developing complications. One of the reasons for such unintentional delay would be the hypercoagulative status of patients taking warfarin. The CHEST 2008 guidelines suggest reversing warfarin with Vitamin K for patients who need urgent operation. The aim of this study is to compare different roots and doses of Vitamin K.


Eligibility Criteria:
Inclusion Criteria:

* hip fracture patients on warfarin

Exclusion Criteria:

* pregnancy
* vitamin k sensitivity
A Study With a Initial Treatment Period Followed by a Randomized-withdrawal Period to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis

Phase 3 study to compare the efficacy of bimekizumab versus placebo in the treatment of subjects with moderate to severe chronic plaque psoriasis.


Eligibility Criteria:
Inclusion Criteria:

* Must be at least 18 years of age
* Chronic plaque psoriasis (PSO) for at least 6 months prior to the Screening Visit
* Psoriasis Area Severity Index (PASI) \>=12 and body surface area (BSA) affected by PSO \>=10% and Investigator's Global Assessment (IGA) score \>=3 on a 5-point scale
* Subject is a candidate for systemic PSO therapy and/or phototherapy
* Female subject of child bearing potential must be willing to use highly effective method of contraception

Exclusion Criteria:

* Subject has an active infection (except common cold), a recent serious infection, or a history of opportunistic, recurrent, or chronic infections
* Subject has concurrent acute or chronic viral hepatitis B or C or human immunodeficiency virus (HIV) infection
* Subject has known tuberculosis (TB) infection, is at high risk of acquiring TB infection, or has current or history of nontuberculous mycobacterium (NTMB) infection
* Subject has any other condition, including medical or psychiatric, which, in the Investigator's judgment, would make the subject unsuitable for inclusion in the study
* Presence of active suicidal ideation or positive suicide behavior
* Presence of moderately severe major depression or severe major depression
* Subject has any active malignancy or history of malignancy within 5 years prior to the Screening Visit EXCEPT treated and considered cured cutaneous squamous or basal cell carcinoma, or in situ cervical cancer