cyrilzakka/clinical-trials huggingface dataset:
Culturally Sensitive Collaborative Treatment for Depressed Chinese Americans

This study will evaluate the effectiveness of culturally sensitive treatment versus regular care in treating depressed Chinese Americans.

Depression is a complex illness that impacts an individual's thoughts, behavior, mood, and physical health. Research has shown that many Asian Americans with depression do not complain about their symptoms or seek treatment, which has lead to an under-recognition of depression in this population. Furthermore, even when a primary care physician does diagnose depression in an Asian American, adequate treatment does not often follow. There is a clear need to understand the cultural reasons for why treatment is not sought out by Asian Americans. There is also a need for developing new treatments that specifically target the Asian American population. Offering culturally sensitive therapies combined with traditional medical care may make depressed Asian Americans more comfortable in seeking treatment for their illness. Culturally Sensitive Collaborative Treatment (CSCT) is a comprehensive approach to treating depression. It incorporates consultation with a culturally trained psychiatrist, medical treatment provided by a primary care provider, and care management provided by a bilingual and bicultural care manager. The purpose of this study is to evaluate the effectiveness of CSCT versus traditional medical care for the treatment of depression in Chinese Americans.

This 24-week study will enroll depressed Chinese Americans. Potential participants will be interviewed in primary care clinics to screen for depression. Once enrolled, all participants will attend a consultation with a psychiatrist trained in cultural sensitivity to introduce the concept and treatment of depression. Participants will then be randomly assigned to either CSCT or standard care. Both groups of participants will receive regular care from their primary care provider, but the CSCT group will also meet with a bilingual and bicultural care manager to learn how to fully manage their depression. Outcome measurements will include symptoms of depression; adherence to appointments with primary care providers; adherence to medication treatment; and adverse events. All measurements will be assessed during follow-up phone calls at Weeks 2, 6, 10, 14, 18, 22, and 24.

Eligibility Criteria:
Inclusion Criteria:

* Chinese ethnicity
* Currently depressed as determined by a total score of at least 16 on the CBCI scale
* Speaks and understands English or Chinese (including Mandarin, Cantonese, and Taiwanese dialect)
* Willing to participate in follow-up phone calls

Exclusion Criteria:

* Currently at risk for suicide
* Current unstable medical illness
* Current clinical or laboratory evidence of hypothyroidism
* Diagnosed with any of the following in addition to depression: organic mental disorder; schizophrenia; delusional disorder; psychotic disorder; bipolar disorder; mood congruent or mood incongruent psychotic features
* History of treatment by a psychiatrist within 4 months of study entry
* History of alcohol or substance abuse within 1 year of study entry
A Multi-Center, Randomized, Open-Label Study to Assess the Immunogenicity and Safety of Denosumab in Pre-filled Syringe Compared to Vial in Subjects With Low Bone Mineral Density

The purpose of this study is to compare the immunogenicity profiles of denosumab pre-filled syringe (PFS) and vial at 6 months in postmenopausal women with low bone mineral density (BMD).


Eligibility Criteria:
Inclusion Criteria:

* Patients who have successfully completed the 20050141 study (NCT00330460):

  * Must have received all SC investigational product administrations in 20050141
  * Must not have taken any proscribed therapies in 20050141
  * Subjects who were in the alendronate or denosumab treatment group are allowed
* Provide signed informed consent before any study-specific procedures are conducted

Exclusion Criteria:

* Any disorder that, in the opinion of the investigator, may compromise the ability of the patient to give written informed consent and/or comply with study procedures including:

  * Any physical or psychiatric disorder
  * Or evidence of alcohol or substance abuse in the last 12 months
* Any clinical evidence, in the medical judgement of the investigator, of the following medical conditions:

  * Impaired thyroid function (subsequent to treatment)
  * Impaired hepatic function
  * Impaired renal function
  * Rheumatoid Arthritis, Paget's disease, Cushing's disease, hyperprolactinemia, or cirrhosis of the liver
  * Known to have tested positive for human immunodeficiency virus, hepatitis C virus, or hepatitis B surface antigen
  * Any metabolic bone disease, eg, osteomalacia or osteogenesis imperfecta, which may interfere with the interpretation of the findings
Anterior Cruciate Ligament Injury Prevention Protocol in Female Football Players With Dynamic Knee Valgus

Introduction: Women's football has experienced exponential growth over the last ten years. Its popularity is associated with an increase in anterior cruciate ligament injuries (ACL). They constitute a major current problem as they account for 43% of the injury burden during the sport season. Despite existing training programmes, no uniform criteria have been established to design a precise intervention protocol, with specific tasks linked to women's football, nor has it been proposed to optimise current programmes.

Objective: To evaluate the efficacy of a comprehensive and specific training protocol focused on female football players with dynamic knee valgus (DKV) to prevent ACL injuries.

Methodology: Randomised, double-blind, single-centre clinical trial protocol scheduled for the 2023-2024 season of women's football. There will be 2 groups: a group that will follow a specific ACL injury prevention protocol and a control group. The intervention period will last 12 weeks. Measurements will be taken at 3 time points. The biomechanics of the lower extremities, the dynamics of jumping and landing, as well as the pre and post training satisfaction of the players will be evaluated. Image capture and processing systems will be used in addition to tests such as the drop vertical jump test (DVJ), the LESS scoring system, among others.

Future expectations: This protocol aims to be one of the first to implement an ACL injury prevention programme for women football players with DKV. Despite the scarcity of research in this area, studies support beneficial effects at a preventive level.


Eligibility Criteria:
Inclusion Criteria:

* Female football players registered and federated in the corresponding team.
* With an age range between 18 and 35 years old.
* Minimum experience of one year playing football.
* With DKV presence.

Exclusion Criteria:

* Subjects with previous ACL or other ligamentous injury to the knee.
* Subjects with a history of lower extremity injury resulting in surgery during the six months prior to the study.
* Players with chronic illnesses that may affect test results.
* Subjects who played other sports at a professional level.
SEINIOR:Quality of Life and Breast Cancer in Older Women

Background :

Breast cancer is a disease that occurs primarily in elderly women: 54057 of breast cancer occurred on women in 2008, 15.2% were between 75 and 84 years and 5.4% were over 85 years. Elderly women cancers care exposes to several problems: the opportunity for screening, knowing that mammography is not recommended after 75 years old, and the level of treatment depending on the background and the existence of weaknesses. It should determine whether patients are in adequate physiological condition to tolerate classical and "complete" treatment or conversely in a precarious state with advanced fragility, justifying only lightened and adapted symptomatic treatment.

Purpose :

The purpose of this research theme is to assess the quality of life of elderly patients who underwent mastectomy for breast cancer. The objectives are:

* Assess the determinants of acceptance and / or rejection of mastectomy based on personal background (level of fragility, self-image) and linked to cancer
* Assess the quality of life, 6 months later, of women who underwent or not mastectomy, and appreciate the determinants

Abstract :

The total mastectomy allow, oncologically, a more valid treatment than a lumpectomy, in many cases of women suffering from a breast cancer, but its relevance and acceptability are poorly known. Some think that an elderly woman, postmenopausal, is less concerned with her aesthetics and feminine attributes, which would allow her to accept easily the mastectomy.

The research hypothesis is that the acceptability of mastectomy is not good in elderly women

Primary outcome:

Better detection of comorbidity and geriatric syndromes in vulnerable patients Better detection of a degradation of the quality of life at D0 (at diagnosis)

Secondary outcomes:

Better support for quality of life and psychological support after mastectomy (revaluation to 6 months) Integration of patients in the geriatric sector and implementation of regular monitoring Study design: prospective, multicenter

Eligibility Criteria:
Inclusion Criteria:

1. Elderly patients about or over 75 years
2. Female
3. Patients in whom a diagnosis of breast cancer with surgical indication for mastectomy with or without lymph node dissection is discussed
4. Ability to understand and give freely consent
5. Informed consent signed
6. Patient affiliated to the social security or entitled

Exclusion Criteria:

1. Patients under 75 years
2. Male
3. Patients under legal protection
Postnatal Nutrition and Physical Activity in Obese Asthmatic Children

The aim of this study was to compare the duration of breast milk intake, vitamin D intake, asthma control level and physical activity levels between obese asthmatic children and non-obese children. This was a prospective study in children aged 8-17 years with asthma. Asthma control level was evaluated by asthma control test and physical activity level was evaluated by Physical Activity Questionnaire for Children (IPAQ-C) and leisure time activity scale.

Asthma and obesity, which are important public health problems and are common in childhood, are chronic diseases. The aim of this study was to compare breastfeeding duration, vitamin D intake, asthma control and physical activity levels between obese asthmatic children and non-obese children.

The study was a prospective study conducted in children aged 8-17 years with asthma. Demographic information of the children was recorded. Asthma control level was assessed by asthma control test and physical activity level was assessed by Physical Activity Questionnaire for Children (IPAQ-C) and leisure time activity scale.

It was conducted as a single-blind, prospective study in which the patients were randomized by simple randomization method as obese asthmatic children (experimental group) and non-obese asthmatic children (control group) according to the order of admission to the hospital.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed with asthma by a pediatrician,
* not in the attack process,
* no mental problems,
* do not have any systemic disease accompanying asthma (diabetes, etc.)
* children who voluntarily agreed to participate in the study

Exclusion Criteria:

* severe posture disorders
* idiopathic scoliosis and idiopathic rheumatic disease
* history of orthopedic surgery
* children with mental retardation or a neurological problem
The Effects of Online Mat Pilates and Face-to-Face Equipment-Based Pilates on Pain, Kinesiophobia, and Balance in Individuals With Non-Specific Low Back Pain

Non-specific low back pain (NSLBP) is a common musculoskeletal condition that affects a significant portion of the population and often leads to limitations in daily activities, reduced quality of life, and increased levels of kinesiophobi

compare the effects of online mat Pilates and face-to-face equipment-based Pilates on pain, kinesiophobia, and balance in individuals with NSLBP. While both methods emphasize neuromuscular control and alignment, differences in delivery modes and equipment usage may influence outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 18 and 60 years
* Non-specific low back pain for more than 12 weeks
* No clear pathological diagnosis
* Physically and cognitively capable of performing the exercises
* Pain level between 3 and 7 on the Visual Analog Scale (VAS)

Exclusion Criteria:

* Pregnancy
* Spinal surgery in the last 6 months
* Neurological or chronic systemic diseases
* Movement restriction due to severe pain
End-range Maitland Mobilization on Glenohumeral Internal Rotation Deficit and Proprioception

Glenohumeral internal rotation deficit (GIRD) is one of the main reasons for glenohumeral pain in athletes with over-head activity. As GIRD increases, the ratio between internal and external rotation changes resulting in decreased joint stability.

Joint mobilization is a possible option for the decrease of GIRD and contribution to improvement of proprioception in addition to physical therapy. The aim of this trial is to investigate the effect of end-range Maitland mobilization in addition to physical therapy on GIRD, other joint movements and proprioception.

Glenohumeral internal rotation deficit (GIRD) is one of the main reasons for glenohumeral pain in athletes with over-head activity. As GIRD increases, the ratio between internal and external rotation changes resulting in decreased joint stability. The occurence of GIRD and decreased joint proprioception may lead to different shoulder pathologies (e.g. Impingement syndrome).

Joint mobilization is a possible option for the decrease of GIRD and contribution to improvement of proprioception in addition to physical therapy. Several joint mobilization techniques exists, which can be applied for stretching of periarticular tissues. Maitland mobilization is a well applied mobilization type. The effectiveness of both end-range and not end-range Maitland mobilization in lengthening of periarticular tissues and improvement of joint proprioception has been previously confirmed amongst several diseases. However, the effect of end-range Maitland mobilization on decrease of GIRD and proprioception in addition to physical therapy has not been investigated in volleyball players so far.

The aim of this trial is to investigate the effect of end-range Maitland mobilization in addition to physical therapy on GIRD, other joint movements and proprioception.

Eligibility Criteria:
Inclusion Criteria:

* National Championship players in I. or II. level
* at least, 10 degree deficit of glenohumeral internal rotation in the dominant shoulder compared to the non-dominant hand

Exclusion Criteria:

* previous trauma or surgery on the dominant shoulder
* participation in any kind of treatment during the intervention period
Mechanism of Aphakic and Pseudophakic Glaucoma in Pediatric Patients

In cell cultures, lens epithelial cells and trabecular meshwork cells will be exposed to aqueous humor from pediatric eyes undergoing cataract removal surgery. Cytokine analysis of candidate factors will be performed before and after exposure to lens epithelial.

Aqueous from the anterior chamber will be withdrawn before surgery. Then the lens capsule will be opened (capsulorhexis) and removed. The lens material will be removed. All 3 components will be sent to the lab.

Lens epithelial cells will be isolated and will be used in a co-culture setup with trabecular cells to investigate the interactions between lens cells and trabecular cells. Understanding the interaction between young and adult lens cells on trabecular cell will shed light on mechanism of infantile aphakic glaucoma.

Aqueous humor taken out before cataract surgery and before glaucoma operation of aphakic eyes will be used for analysis of growth factor and cytokines in the Aphakic eye using proteins membrane arrays. Eyes before cataract surgery will be used as controls. Such analysis will shed light on the possible factors affecting trabecular cells in aphakic eye.

Eligibility Criteria:
Inclusion Criteria:

* children with congenital cataract and are going to do removal surgery
* children with aphakic or pseudophakic glaucoma and are going to do glaucoma surgery
* both of parents are able to sign the INFORMED CONSENT FORM

Exclusion Criteria:

* patients with other eye diseases apart from congenital cataract(in children with congenital cataract) and aphakic or pseudophakic glaucoma (in children with aphakic or pseudophakic glaucoma)
Hepatitis B Vaccination (HBV) in HIV Infected Children

The purpose of this study is :

* To evaluate prevalence of protective hepatitis B antibody comparing intradermal (ID) and intramuscular (IM) route in antiHbsAb negative HIV infected children treated with highly active antiretroviral therapy (HAART)
* To revaccinate the HBV vaccine in the children who didn't have protective HBV Ab

Hepatitis B virus (HBV) and HIV share the same route of transmission and can have co-infection. The prevalence of this co-infection was 8.7% in Thai adult\[1, 2\] and 12.1% in African HIV vertically transmitted children\[3\]. Occurrence of HBV has effects to treatment due to having the same medication, lamivudine, tenofovir, emtricitabine or entecavir, to anti HIV medication. HBV can cause chronic liver disease, cirrhosis and hepatocellular carcinoma.

In Thailand, the routine HBV vaccination program was started since 1992. Few reports in severe immune compromise HIV children has been shown to lose their expected preventive measles and hepatitis B antibody from history of scheduled vaccination even after the immune recovery by HAART\[4, 5\]. Limited data in of prevalence of protective hepatitis B antibody response after immune recovery in Thai HIV infected children treated with highly active antiretroviral therapy. In addition, HBV revaccination in this group of children should be considered\[6\].

The response of HBV revaccination intramuscularly (IM) at 0, 2 and 6 months in 63 HIV children shown response rates 17.4, 82.5, and 92.1% at 2, 6 and 7 months respectively\[6\]. Protective anti-HBs were shown in the majority of non-responders to IM HBV vaccine health care workers \[21/23 (91.3%)\] by two doses of intradermal route (ID)\[7\].

We hypothesize to see the faster and higher response of antiHBs after first dose of ID compare to IM in anti HBsAb negative HIV infected children. No randomized control trial compare antibody response between IM and ID route in HIV children after immune recovery. The benefit from this trial would be decreased the vaccine cost for resourced limited country.

Eligibility Criteria:
Inclusion Criteria:

* HIV infected individuals
* Age 1-18 years
* Current CD4 within 6 months ≥ 15% or ≥ 200 cells/ml in children age ≥ 6 years
* Signed written informed consent
* Negative HBs Ag, antiHBs, and antiHBc at screening visit

Exclusion Criteria:

* Active AIDS
* Active opportunistic infection
* Platelet \< 50,000/ mm3 at screening visit
* History of hypersensitivity to HBV vaccine
* Using oral steroid or immunosuppressive drugs
Randomized Study of TransAeris® System in Cardiac Surgery Patients at Risk of Prolonged Mechanical Ventilation

This study will be conducted as a randomized trial of the TransAeris system for the prevention and treatment of ventilator-induced diaphragm dysfunction (VIDD) in patients identified prior to surgery to be at greater risk of prolonged mechanical ventilation (PMV).

This study is an open label, randomized, cross-over study in adult open cardiac surgery patients. All subjects will receive TransLoc electrodes at the time of open sternotomy cardiac procedure. Half of subjects will have TransAeris turned on upon entry to ICU, the other half will receive standard of care with TransAeris turned on if still intubated on mechanical ventilation after 120 hours.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is undergoing an open cardiac procedure by median sternotomy
2. Subject is at risk of prolonged mechanical ventilation according to one or more of the following criteria:

   * Prior open cardiac surgery
   * Left Ventricular Ejection Fraction (LVEF) ≤ 30%
   * History of TIA or CVA
   * Pre-operative or anticipated intraoperative intra-aortic balloon pump
   * History of COPD
3. Subject is at least 22 years of age
4. Informed consent has been obtained from the patient

Exclusion Criteria:

1. Subject is on invasive mechanical ventilation prior to procedure
2. Subject has known or pre-existing phrenic nerve paralysis
3. Subject is having a left ventricular assist device implanted
4. Subject has progressive, non-reversible neuromuscular disease affecting the diaphragm
5. Subject is pregnant or lactating
6. Subject is actively participating in another clinical study which could affect outcomes in this study
A Study of Ocrelizumab in Participants With Relapsing Remitting Multiple Sclerosis (RRMS) Who Have Had a Suboptimal Response to an Adequate Course of Disease-Modifying Treatment (DMT)

The purpose of this prospective, multicenter, open-label, efficacy, and safety study is to assess the efficacy and safety of ocrelizumab in participants with Relapsing Remitting Multiple Sclerosis (RRMS) who have had a suboptimal response to an adequate course of a Disease-Modifying Treatment (DMT). The study will consist of a Screening period (up to 4 weeks), an Open-label treatment period (96 weeks; with last dose administered at Week 72), and a Follow-up period of at least 2 years.


Eligibility Criteria:
Inclusion Criteria:

* Have a definite diagnosis of RRMS, confirmed as per the revised McDonald 2010 criteria
* Have a length of disease duration, from first symptom, of less than (\<) 10 years
* Have received no more than two prior DMTs, and the discontinuation of the most recent DMT was due to lack of efficacy
* Suboptimal disease control while on a DMT
* Expanded Disability Status Scale (EDSS) of 0.0 to 4.0, inclusive, at Screening
* For women of childbearing potential: agreement to use an acceptable birth control method during the treatment period and for at least 6 months after the last dose of study drug

Exclusion Criteria:

* Secondary progressive multiple sclerosis (SPMS) or history of primary progressive or progressive relapsing multiple sclerosis (MS)
* Inability to complete an Magnetic Resonance Imaging (MRI) procedure
* Known presence of other neurological disorders
* Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study
* History or currently active primary or secondary immunodeficiency
* History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
* History of opportunistic infections
* History or known presence of recurrent or chronic infection
* History of malignancy
* Congestive heart failure
* Known active bacterial, viral, fungal, mycobacterial infection or other infection, excluding fungal infection of nail beds