cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of Subcutaneous Secukinumab in Adults With Moderate to Severe Scalp Psoriasis

This study will assess the efficacy and safety of secukinumab compared to placebo in adult patients who have moderate to severe scalp psoriasis that is poorly controlled by current psoriasis treatments.


Eligibility Criteria:
Inclusion Criteria:

* Chronic scalp psoriasis for at least the previous six months
* Moderate to severe scalp psoriasis as defined by a PSSI score of ≥12 and 30% or higher of scalp surface area affected
* Must be candidates for systemic therapy, which means having scalp psoriasis inadequately controlled by topical treatments (corticosteroids), and/or phototherapy, and/or previous systemic therapy.

Exclusion Criteria:

* Forms of psoriasis other than chronic plaque
* Drug-induced psoriasis (e.g., new onset or current exacerbation from β-blockers, calcium channel inhibitors)
* Ongoing use of prohibited treatments (e.g., topical or systemic corticosteroids, UV therapy)
* Prior exposure to secukinumab (AIN457) or any other biologic drug directly targeting IL17A or IL-17RA receptors
* Use of other investigational drugs within 30 days prior to study entry, or within a period of 5 half-lives of the investigational treatment, whichever is longer
* Active, ongoing inflammatory diseases other than psoriasis that might confound the evaluation of the benefit of secukinumab
* Active system infections (with the exception of the common cold) during the two weeks prior to starting study treatment
* Other protocol-defined inclusion/exclusion criteria may apply
Microbiota and Allergy

Food allergy derives from a dysregulation of oral tolerance mechanisms. Studies suggest a crucial role for gut microbiota in oral tolerance development. An altered composition of gut microbiota results in an unbalanced local and systemic immune response to food allergens. There are qualitative and quantitative differences in gut microbiota composition in children with food allergy. Preliminary results of MATFA study demonstrated gut microbiota in allergic children.These findings support the pivotal role of the gut microbiota in the pathogenesis of allergic diseases and may open new strategies in the development of innovative preventive and therapeutic approaches.


Eligibility Criteria:
Inclusion Criteria:

* Children with sure diagnosis of food allergy,
* children with sure diagnosis of respiratory allergy

Exclusion Criteria:

* age at enrollment \<48 months or \>84 months;
* eosinophilic disorders of the gastrointestinal tract;
* chronic systemic diseases;
* congenital cardiac defects;
* acute or chronic infections;
* autoimmune diseases;
* immunodeficiencies;
* chronic inflammatory bowel diseases;
* celiac disease;
* cystic fibrosis or other forms of primary pancreatic insufficiency;
* genetic and metabolic diseases;
* food intolerances;
* malignancy;
* chronic pulmonary diseases;
* malformations of the respiratory tract or of the gastrointestinal tract;
* pre-, pro- or sinbiotic use in the previous 3 months;
* antibiotics or gastric acidity inhibitors use in the previous 3 months.
HIPEC Combined Gastrectomy in Patients With Advanced Gastric Cancer Received Neoadjuvant Chemotherapy

Patients with stage cT3-4N+M0 gastric cancer were recommended to receive neoadjuvant chemotherapy before radical surgery in terms of the eradication of micrometastasis in addition to local control, higher compliance with intensive chemotherapy, and avoidance of futile surgery by detection of initially invisible distant metastasis after rapid disease progression. However, in some studies, gastrectomy followed by neoadjuvant chemotherapy failed to demonstrate survival benefits for these patients. And peritoneal recurrence was the most common and devastating reason. Hyperthermic intraperitoneal chemotherapy (HIPEC) was introduced for peritoneal cancer last century. A few studies suggested HIPEC could improve prognosis in patients with limited peritoneal metastasis from various cancer. In summary, we conducted this study to confirm the efficacy and safety of HIPEC after gastrectomy in patients with advanced gastric cancer received neoadjuvant chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* histologically proven adenocarcinoma of stomach
* stage cT3-4N+M0
* no involvement of esophagus \> 3 cm
* ECOG (Eastern Cooperative Oncology Group) : 0\~1
* no previous chemotherapy or radiotherapy for any malignancy
* no previous surgery for GC excluding endoscopic mucosal resection or endoscopic submucosal dissection
* Signed the Informed Consent Form

Exclusion Criteria:

* Serious diseases that are difficult to control
* Severe hepatic and renal dysfunction
* Abnormal coagulation
* The presence of other serious physical or mental illness or laboratory abnormalities may increase the risk of participating in the study, or interfere with the results of the study, as well as the patients who the investigator believes are not suitable for participating in the study
Protein Supplementation of Snakehead Fish Cookies on Pregnant Women

This study was randomized controlled trial study whose subjects were pregnant women in Sleman District, Yogyakarta, Indonesia. The aims of this study were to make snakehead fish cookies formula which can be well accepted by pregnant women and to observed its effect on fetal growth and birth weight and length. It was hypothesized that snakehead fish cookies could prevent intrauterine fetal growth (IUGR) and low birth weight (LBW).

Subjects on this study were randomly allocated into two groups which were treatment and control group. Subjects in treatment group were given snakehead fish cookies, while subject in control group received standard cookies. The intervention period lasted until subjects delivered their babies.

Subjects were enrolled from Public Health Center (puskesmas) in Sleman District, Yogyakarta Province, Indonesia. Subjects were being explained about the study intervention and were given informed consent as an approval of joining this study. The intervention was given everyday as much as 75g cookies for several weeks period (until delivery). Examination on fetal growth was done every month for each subjects. Birth weight and length were collected after delivery from child health book record.

Eligibility Criteria:
Inclusion Criteria:

1. second and third trimester gestational age,
2. lower-class family with income under Sleman District minimum wage in 2019 (\< 1,701,000 Rupiah),
3. pregnant women of under 25 years old, and
4. high school graduate or below

Exclusion Criteria:

1. suffering from anemia,
2. experiencing preeclampsia,
3. having multiple gestational, and
4. allergic to fish, eggs, and chocolate.
The Amager Project: Intervention After Suicide Attempt

Background:

Repetition rate after a suicide attempt and self harm is very high, about 12-30 percent. Studies, reviewed by Hawton, 1999 show a lack of evidence for psychosocial interventions. Compliance with aftercare is also often very poor.

Objective:

Inspired by the Norwegian Baerum project, the aim is to study if active, assertive outreach, seeking contact, talking about problem solution, motivate to comply to other appointments, will reduce repetition of suicidal acts in the following years.

Methods:

The design is a prospective randomized, controlled trial. The patients (immediately after a suicide attempt or deliberate self harm)) included are randomized to intervention or standard (treatment as usual), aiming at at least 60 persons in each arm. The intervention is carried out through research nurses with about 8 home visits, phone contact, phone messaging, e-mails.Included are persons 12 years of age and older, danish speaking without translator and without diagnoses of severe mental illness (schizophrenia, bipolar illness, mania and severe/psychotic depression) or severe dementia.

Results:

Outcome is measured by repetition of suicidal act (suicide attempt, self harm or completed suicide)as recorded in medical records and by the Danish Cause of Death Register. Repetition measured by persons and by acts throughout 1 year, 2 and 3 years periods. Additional outcome is number and character of health system contacts.


Eligibility Criteria:
Inclusion Criteria:

* Suicide attempt and self harm

Exclusion Criteria:

* Severe mental diagnosis (schizophrenia, psychosis, bipolar affective disorder, severe/psychotic depression, severe dementia)
Group Intervention to Increase Physical Activity in Childhood Cancer Survivors

The primary aim of this randomized, controlled study is to evaluate the impact and feasibility of a prolonged physical activity intervention in school-aged childhood cancer survivors who self-report sedentary lifestyles. The study will test the hypothesis that childhood cancer survivors participating in a physical activity intervention guided by Social Cognitive Theory will increase the amount of time spent daily in moderate to vigorous physical activity, and improve exercise self-efficacy compared to children randomized to usual care. A secondary aim is to assess the impact of the intervention on cardiovascular risk factors including fitness and body composition.


Eligibility Criteria:
Inclusion Criteria:

1. Cancer survivors ages 8-12 years.
2. Off therapy for at least 3 months and not more than 5 years and in remission.
3. Medical clearance to participate in physical activities from the survivor's primary oncology provider;
4. Self-report of \< 60 minutes of moderate to vigorous physical activity (MVPA) per day.
5. Must be able to ambulate.
6. Signed informed consent/assent.

Exclusion Criteria:

None
Innovative Delivery of Evidence Based Psychotherapy to Women With Military Sexual Trauma

The purpose of this study is to determine whether a scientifically validated treatment for Posttraumatic Stress Disorder (PTSD) called Prolonged Exposure (PE) can be delivered effectively to Veterans with Military Sexual Trauma (MST) related PTSD using videoconferencing technology, which allows a therapist and patient who are not in the same room as one another to communicate. The investigators are interested in learning if this form of mental health service delivery is an acceptable alternative to traditional face-to-face therapy delivered with the therapist in the same room as the patient. This study is being conducted at the Charleston VA Medical Center and surrounding Community-Based Outpatient Clinics (CBOCs), and will involve approximately 100 female participants.

The purpose of this project is to test, using mixed qualitative and quantitative assessment strategies, the efficacy of PE delivered via home-based telehealth (PE-HBT) versus PE delivered via standard service delivery (PE-SD) using a randomized, between groups, repeated measures design.

Objective 1: To compare, at post, 3 and 6-month follow-up, whether PE-HBT is superior to PE-SD across critical clinical and quality of life outcomes (i.e., PTSD, depression, quality of life) due to increased PE 'dosing' that results from improved session attendance and reduced attrition.

Hypothesis 1: In intent-to-treat analyses, PE-HBT will be more effective than PE-SD at improving clinical and quality of life outcomes at post, 3, and 6-month follow-up; improvement will correlate with session attendance, which will be higher in PE-HBT.

Objective 2: To compare at post-intervention whether PE-HBT is superior to PE-SD across critical process outcomes (e.g., session attendance, satisfaction, and treatment adherence).

Hypothesis 2: PE-HBT will yield better process outcomes than PE-SD post-intervention.

Exploratory Aims: (1) To determine if treatment adherence and other process variables mediate the relationship between treatment condition and clinical and quality of life outcomes as noted in Objective 1; and (2) To use qualitative interviewing methods to obtain data on Veterans' reactions, preferences, difficulties, and suggestions for MST services.

Eligibility Criteria:
Inclusion Criteria:

1. MST-related index event
2. Diagnosis of PTSD-related MST
3. Female

Exclusion Criteria:

1. Having a household member of spouse who is already enrolled in the study
2. Active psychosis or dementia
3. Suicidal and/or homicidal ideation with clear intent
4. Current substance dependence
5. Concurrent enrollment in another clinical trial for PTSD or depression
6. Unwilling to make regular appointments (note that if the participant has medical/transportation barriers that render her unable to make set appointments, this is not grounds for exclusion).
Tailored Approaches to Improve Medication Adherence

The purpose of this study is to to culturally tailor a technology-based individualized adherence intervention for Black and Latino patients with uncontrolled HTN or T2DM, who are non-adherent to their medications, and determine its acceptability.

Using a randomized controlled trial design, this study will compare the efficacy of a tailored adherence intervention (TAI) to a single patient education (PE) session, on medication adherence among 40 high-risk Black and Latino patients with uncontrolled hypertension (HTN) who are non-adherent to their prescribed antihypertensive medications. Patients randomized to the PE group will receive a single tablet delivered patient education session at the baseline visit. Patients randomized to the TAI group will complete a tailoring survey at the baseline visit to identify the most salient adherence barriers to the individual, which will be used to create an individualized adherence profile. Following completion of the tailoring survey, patients will collaborate with the RA to identify the most suitable mix of intervention strategies for improving medication adherence (i.e., reminder aids, motivational interviewing, case management) that are matched to the barriers outlined on patients' individualized adherence profiles.

Eligibility Criteria:
Inclusion Criteria:

* Have uncontrolled hypertension defined as BP\>140/90 mmHg on at least two consecutive visits in the past year (or BP\>130/80 mmHg for those with diabetes or kidney disease) and Framingham Risk Scores (FRS) \>20% (or at least one CVD risk factor including hyperlipidemia or diabetes);
* Have been prescribed at least one antihypertensive or oral anti-diabetic medication;
* Self-identify as Latino or African American/Black
* Be \> 18 years of age

Exclusion Criteria:

* Refuse or are unable to provide informed consent;
* Currently participate in another hypertension study; or 2 diabetes study
* Have significant psychiatric comorbidity
* Plan to discontinue care at the clinic within the next 3 months

Vulnerable populations including adults unable to provide informed consent, pregnant women, and prisoners will be excluded from this study.
Real-world Study on Adjuvant Octreotide Therapy in pNETs

Adjuvant therapy in pancreatic neuroendocrine tumors (pNETs) after radical resection lacks evidence-based data and is controversial. Real-world data were clustered to validate whether the long-acting octreotide is a potential candidate for adjuvant therapy in high recurrence risk G2 pNET patients.

Adjuvant therapy for pNETs was proposed as an unmet clinical need by the European Neuroendocrine Tumor Society Group in 2016.1The Clinical Practice Guidelines for pNETs in China recommended initiation of clinical trials to investigate the role of adjuvant therapy for patients with a high-risk of recurrence. To address this unmet clinical need, the investigators initiated this real-world study. The aim of the current study was to assess the impact of octreotide LAR as an adjuvant therapy in reducing recurrence and prolonging survival in Chinese non-metastatic pNETs patients at risk for recurrence.

Eligibility Criteria:
Inclusion Criteria:

* pNETs lesions pathologically classified as WHO grade 2
* Complete surgical resection (R0 or R1 was achieved)
* Adjuvant treatment was performed within 12 weeks after surgery

Exclusion Criteria:

* Stage IV
* Other oncological history
* Previous antineoplastic systemic therapy
* Lack of information/details on recurrence or death.
The Anifrolumab PRIM Program

Pregnancy and infant outcomes in anifrolumab exposed pregnancies using PRegnancy outcomes Intensive Monitoring (PRIM) data: The anifrolumab PRIM program

The anifrolumab PRIM program is a supplementary program which utilizes enhanced collection of secondary data from reported anifrolumab-exposed pregnancies collected as part of AstraZeneca's PV system.

Initial information about the exposed pregnancy will be collected through the pregnancy report submitted by anifrolumab treated patients or HCPs to the AstraZeneca PV database. Pregnancy outcome information will be collected in close proximity to the planned delivery. Additional follow-up and outcome information will be collected 12 months after delivery. For PV reports of exposed pregnancies that have already had a pregnancy outcome at the time of initial report (retrospective cases), initial characteristics, pregnancy outcome, and any available infant health information will be collected at the time of the initial report.

Targeted follow-up checklists and guidance documents will ensure that PV data collected for anifrolumab-exposed pregnancies are as complete as possible and have been mapped for pre-specified analytic variables that will be used to evaluate the safety of anifrolumab exposure for pregnancy and infant outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Currently or recently (within 1 year of pregnancy outcome) pregnant
* Exposure to at least 1 dose of anifrolumab at any time during pregnancy or in the 16 weeks prior to date of conception

Exclusion Criteria:

* Pregnancy cases that have been enrolled in the prospective pregnancy registry (D3461R00051), those reported prior to the start of the PRIM program, or those that have been exposed to known teratogens or investigational medications will be excluded from the anifrolumab PRIM study.
Comparison Of The Sacroiliac Manipulation And Kinesiological Tape In Basketball Players

In the USA, basketball is the most popular team sport for boys and girls enrolled in the 2003-2004 school year. Many countries offer opportunities for young people to learn the game in a variety of settings, from physical education classes, school competitions, public and private sports organizations to community entertainment programmes. While the USA has long been seen as the dominant power in basketball, recent results in competitions such as the 1988 and 2004 Men's Olympic Games and 2002 World Championships show the rest of the world is closing the gap. Basketball continues to spread around the world, thanks to ongoing development programs for children and youth .

One of the important parameters of postural control during landing after jump is stabilization time. There are several studies proving the curative effect of kinesio taping. However, studies investigating the effect of sacroiliac chiropractic manipulation are more limited than kinesio taping studies. There are fewer studies evaluating the performance of trait juvenile basketball players. Although there is evidence showing the effect of manipulation on performance, Botelho et al. state that scientific evidence in this area is lacking.

Eligibility Criteria:
Inclusion criteria

* Being a licensed basketball player in amateur leagues in Istanbul
* Being between the ages of 18-25
* Being a man
* Voluntarily participating in the study
* Not having a verbal communication barrier

Exclusion criteria

* Being under 18 years old or over 25 years old
* Spondylolysis or spondylolisthesis
* Neurological problems (acute myelopathy, spinal cord compression, cauda equina syndrome, radicular impingement)
* Hypermobile joints
* Acute fractures
* Intracanalicular hematomas
* Spinal cord hematomas in the spine
* Postoperative fixation prostheses
* Neoplastic diseases of muscle or other tissues
* To have a surgical operation on the knee and waist region in the last year
* Osteoporosis with risk of fracture
* Vertebrobasilar insufficiency
Optimizing 6-mercaptopurine Therapy in Pediatric Acute Lymphoblastic Leukemia by Using Allopurinol

The study will investigate, in children with acute lymphoblastic leukemia during maintenance treatment, if addition of allopurinol to conventional oral 6-mercaptopurine and methotrexate therapy, affects erythrocyte concentrations of 6-thioguanine and 6 methylmercaptopurine. The effect on hematological and liver toxicity parameters in blood will also be investigated as well as clinical toxicity.

After one month of conventional maintenance therapy (MT) children and adolescents, treated for acute lymphoblastic leukemia on Nordic protocols and with wild type thiopurine methyltransferase (TPMT) are eligible for the study. They will first receive a 12 week phase with normal MT during which time repeated sampling of 6-mercaptopurine (6MP) metabolite levels and other laboratory parameters will be performed. After 12 weeks, allopurinol at a dose of 50 mg/sqm is added (simultaneously reducing the dose of 6MP by 50%) and during the next 12 weeks patients are monitored closely for toxicity and samples for determination of metabolite levels and hematological and liver toxicity are obtained regularly. If, after 4 weeks of allopurinol treatment, the levels of 6-thioguanine are below 200 nmol/mmol hemoglobin, the dose of allopurinol will be increased to 100 mg/sqm. Allopurinol treatment is continued for 12 weeks after which the patients switch to their original maintenance therapy.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of acute lymphoblastic leukemia
* Treatment according to Nordic Society for pediatric hematology/oncology (NOPHO) ALL2008 based protocols
* Age 0-18y at time of initial diagnosis
* TPMT wild type
* Written informed consent

Exclusion Criteria:

* Mature B cell lymphoblastic leukemia
* t(9;22) positive acute lymphoblastic leukemia
* Unknown TPMT status or presence of TPMT mutation (both heterozygous and homozygous)
* Known intolerance to any of the chemotherapeutic drugs in the protocol
* Major organ failure precluding administration of planned chemotherapy
* Severe liver toxicity defined as persistent (≥ two weeks) elevation of either S-bilirubin \> 50 μmol/l or S-GPT \> 20 x Upper normal limit (UNL) or P-Prothrombin complex \> 1.5.
* Reduced kidney function defined as S-creatinine ≥ 1.5 x UNL.
* Lactating female or female of childbearing potential not using adequate contraception.
Fecal Microbiota Transplantation for Radiation Enteritis

Radiation enteritis is one of the most feared complications after abdominal or pelvic radiation therapy.The gut microbiota is considered to constitute a "microbial organ" which has pivotal roles in the intestinal diseases and body metabolism. Evidence from animal studies demonstrated the link between intestinal bacteria and radiation enteritis. This clinical trial aims to evaluate the efficacy and safety of fecal microbiota transplantation (FMT) for radiation enteritis.

The present clinical trial aims to re-establish a gut functionality state of intestinal microbiota through fecal microbiota transplantation (FMT) for radiation enteritis (RE). FMT is the whole profile of fecal microbiota transplantation. At enrollment, "Shared Decision Making" intervention was applied to support patient involvement in making health decisions. Patients have opportunity to choose fecal microbiota transplantation (FMT). Patients will receive follow-up for at least 12 weeks. Blood test, endoscopy and questionnaire will be used to access participants at study start and at study completion. Fecal microbiota compositions, blood and urinary metabolic profiles of patients will be analyzed to assess associated microbial changes.

Eligibility Criteria:
Inclusion Criteria:

1. age ≥18 years old;
2. Radiation enteritis diagnosed by colonoscopy after finishing radiotherapy.

Exclusion Criteria:

1. Patients who were pregnant or nursing;
2. Patients who were unable or unwilling to undergo a gastroscopy;
3. Patients who had gastrointestinal infection;
4. Patients with cardiopulmonary failure.