cyrilzakka/clinical-trials huggingface dataset:
Clinical Trial of Osteoporosis in Ankylosing Spondylitis

This is an observational study aiming to study the prevalence and risk factors for osteoporosis and vertebral fractures in patients with ankylosing spondylitis attending three Rheumatology clinics in Western Sweden.

Background Ankylosing spondylitis (AS) is a common inflammatory rheumatic disease with a prevalence of 0.5-1.0%. Men are more commonly affected by the disease as compared to women, ratio 2.6-4:1. Pain in the back is a frequent symptom of debut. This pain is often associated with sacroilitis. In later stages also the lumbar, thoracic and cervical spine are hit by the disease. Peripheral joints, eyes, heart, lungs and urinary tract may also be influenced.

Osteoporosis in AS In AS the risk of osteoporosis is increased. However, this field has not yet been significantly studied probably due to several reasons such as the predominance of men with the disease and men are more seldom investigated for osteoporosis compared to women. When AS progresses syndesmophytes of the spine are developed which makes it difficult to assess bone mineral density (BMD) correctly with the conventional method, dual energy x-ray absorptiometry (DXA). Fractures in the spine are easy to foreseen since the pain of the patient might be misjudged to be related to increased disease activity. Fractures are also overlooked in radiographs in AS. AS is associated with both increased bone formation and increased bone resorption. The bone remodeling process in the spine renders the spine less flexible and stiffer and as a consequence also a quite small trauma may result in a fracture. These fractures are often instable risking injuring the spinal cord and nerves.

Aims of the study

* To investigate the prevalence of osteoporosis and osteoporosis related fractures in patients with AS in Western Sweden.
* To identify risk factors for osteoporosis and osteoporosis related fractures in AS.
* To study how fractures in the spine may influence the pain in the back, the flexibility of the spine and the posture of the patients.
* To study to which extent the patients with AS are investigated and treated for osteoporosis.
* To investigate which method is most reliable for measuring BMD in AS.

Design and methods This is an observational study consisting of questionnaires, examination of the patients, blood tests, measures of BMD with different techniques, DXA, both frontal-dorsal and lateral projections, Quantitative Computed Tomography (QCT) and Xtreme CT. Patients with AS from three rheumatology clinics in western Sweden with definite AS will be invited to participate. It is estimated that about 250 patients will be included in the trial. All patients gave informed written consent according to the Declaration of Helsinki. The study has been approved by the Regional Ethics Committee.

Eligibility Criteria:
Inclusion Criteria:

* Definitive Ankylosing spondylitis according to the New York criteria
* At least 18 years old

Exclusion Criteria:

* Pregnant
* Dementia
* Not able to understand, speak or read Swedish
A Study to Evaluate the Effect of Musashino Diabetes Diet in Type II Diabetes Mellitus Disease

Evaluation the change of patients' glycosylated hemoglobin (HbA1c) after 12 weeks diet control

In this study, we provide the delivery service of Musashino T2DM diet for 12 weeks to patients with T2DM, to evaluate the effect on glycosylated hemoglobin (HbA1c), progression and compliance during study period.

Eligibility Criteria:
Inclusion Criteria:

* A baseline of glycosylated hemoglobin(HbA1c) is, 10%≥HbA1c≥7%, during past 1 month
* The subject is able to understand and comply with protocol requirements, instrument
* The subject and/or subject's primary caregiver is able to have the telephone interview use computer and internet assess
* Signed and dated written informed consent

Exclusion Criteria:

* Pregnancy, breastfeeding or planning to become pregnant during the study
* Acute illness or infection requiring treatment within 14 days of study entry
* Other serious disease (e.g. Heart, lung, brain, liver) within 3 months
* Presence of malignancies
* Participate in other clinical trial within 30 days prior to this study
* Alcohol or drug abuse that would interfere with the ability to meet study requirements (opinion of investigator)
* Concurrent significant medical condition that would limit ability to participate in the study
* Consider by the investigator to be unsuitable for study participation, for any reason
Radiation Therapy in Preventing Central Nervous System (CNS) Metastases in Patients With Non-Small Cell Lung Cancer

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known if giving radiation therapy to the head is effective in preventing CNS metastases in patients who have stage III non-small cell lung cancer.

PURPOSE: This randomized phase III trial is studying how well radiation therapy to the head works in preventing CNS metastases in patients who have been previously treated for stage III non-small cell lung cancer.

OBJECTIVES:

* Determine whether prophylactic cranial irradiation improves survival after effective locoregional/systemic therapy in patients with stage IIIA or IIIB non-small cell lung cancer.
* Determine the neuropsychologic impact of this therapy in these patients.
* Assess quality of life of patients receiving this therapy.
* Determine the impact of this therapy on the incidence of CNS metastases in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease stage (IIIA vs IIIB), histology (non-squamous cell vs squamous cell), and prior surgery (yes vs no). Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients undergo prophylactic cranial irradiation 5 days a week for 3 weeks.
* Arm II: Patients undergo observation.

Patients are followed 3 months during the first year, every 6 months for 2-3 years and then annually thereafter. Quality of life is assessed at baseline and at months 6, 12, 24, 36, and 48.

PROJECTED ACCRUAL: A total of 1,058 patients (529 per treatment arm) will be accrued for this study within 36 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of stage IIIA or IIIB non-small cell lung cancer

  * Complete response, partial response, or stable disease after definitive locoregional therapy (with surgery and/or radiation therapy, with or without chemotherapy (chemotherapy alone does not constitute definitive therapy))

    * No more than 16 weeks since prior therapy
* No progressive disease
* No extracranial distant metastatic disease
* No suspicion of CNS metastases by MRI or CT scan

PATIENT CHARACTERISTICS:

Age

* 18 and over

Performance status

* Not specified

Life expectancy

* Not specified

Hematopoietic

* Not specified

Hepatic

* Not specified

Renal

* Not specified

Other

* No other malignancy within the past 3 years except nonmelanoma skin cancer
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

* No concurrent anticancer biologic therapy

Chemotherapy

* See Disease Characteristics
* No concurrent anticancer cytotoxic chemotherapy

Endocrine therapy

* Not specified

Radiotherapy

* See Disease Characteristics
* No prior cranial irradiation

Surgery

* See Disease Characteristics

Other

* Recovered from all prior therapies
* No concurrent enrollment on any other phase III study that has progression-free, disease-free, or overall survival as an endpoint
Evaluating Safety and Efficacy of TOL101 Induction Versus Anti-Thymocyte Globulin to Prevent Kidney Transplant Rejection

Induction therapy with antibodies is administered during transplant surgery and for a short period of time following transplant surgery in an effort to render the immune system less able to mount an initial rejection response. In general, induction therapy is associated with better outcomes compared to the absence of induction therapy. However, currently used induction agents, some of which are not labeled or indicated for induction therapy in transplantation, have drawbacks related to long-term immune system suppression increasing susceptibility to opportunistic infections or malignancies, and other immune-mediated side effects.

An unmet medical need exists for a more specific approach to prevent acute organ rejection, without unnecessarily exposing the patient to non-specific or open-ended immune suppression, which may exacerbate the risks of infections and malignancies. TOL101 is a novel antibody that targets a very specific immune cell type that is critical in the acute organ rejection response. In this two-part study, TOL101 will be evaluated for the prophylaxis of acute organ rejection when used as part of an immunosuppressive regimen that includes steroids, MMF, and tacrolimus in first time kidney transplant recipients.

This study will test the hypothesis that a more specific approach (with TOL101) to prevention of acute organ rejection may provide similar or better efficacy than the currently used induction antibodies (such as Anti-Thymocyte Globulin or Thymoglobulin) while carrying fewer risks in terms of opportunistic infections, malignancies and adverse effects.


Eligibility Criteria:
Inclusion Criteria:

* Recipient of a primary renal transplant from a living or standard criteria cadaveric donor
* Male or female 18-60 years of age
* Recipient with a PRA \< 20%

Exclusion Criteria:

* Previous solid organ transplant
* Recipient of HLA-identical kidney allograft transplant
* Recipient of an ABO incompatible donor kidney
* Known HIV infection or other major infection
* History of malignancy within 3 years (excluding treated basal cell or squamous cell carcinoma of the skin) prior to enrollment
* History of tuberculosis
* Recipient with cardiovascular disease
* Treatment with immunosuppressive medications within 1 month prior to enrollment
* Known or suspected allergy to mice
* Pregnant or lactating
* Unable or unwilling to participate in all required study activities for the duration of the study (6 months)
Regional Block for Upper Abdominal Surgeries

Pain control after major upper abdominal surgeries is an essential step to guard against postoperative complications such as lung atelectasis. This major step can be achieved by opioids or regional blocks.

Regional blocks allow better pain control and avoid side effects of opioid based pain control

Ultrasound guided External oblique intercostal plane block for perioperative analgesia in major upper abdominal surgery: Prospective randomized controlled study

Introduction:

Pain control is a vital component to achieve enhanced recovery after major upper abdominal surgery. Effective postoperative pain control will reduce the incidence of numerous postoperative complications, can facilitate early mobilization and may result in earlier recovery.

Pain control is historically achieved by the administration of opioids, which is associated with well-documented side effects, such as sedation, respiratory depression, pruritus, hallucinations and postoperative nausea and vomiting (PONV). Epidural analgesia, another routinely used analgesic technique, offers equivalent or superior pain scores when compared to conventional systemic opioids. Enhanced recovery following major upper abdominal surgery has gained attention even though there is limited evidence on the efficacy and effectiveness of existing analgesic techniques.

The external oblique intercostal plane block is a new modality that will be used to improve pain-related outcomes after major upper abdominal surgeries, and has not been extensively investigated. Therefore, we will test the hypothesis that external oblique intercostal plane block can reduce cumulative opioid consumption for the patients undergoing major upper abdominal surgery when added to conventional multi-model intravenous analgesic technique.

The aim of this prospective comparative investigation is to assess the impact of external oblique intercostal plane block in a multimodal perioperative analgesic regimen and any related side effects in patients undergoing major upper abdominal surgery.

Patients and Methods:

A prospective study will be carried out in Alexandria Main University Hospital on 120 American society of anaesthesiologists (ASA) II, III physical status aged 20-60 years scheduled for major upper abdominal surgery, after approval of the Medical Ethics Committee and an informed written consent. Patients will be categorized into two equal groups, group I (60) will be subjected to bilateral external oblique intercostal plane block and group II (60) will be subjected to morphine infusion at a rate of 0.03mg/kg/h. During the patient stay in the ICU, total analgesic requirements will be measured in both groups. Also, sedation level, duration of intubation and length of ICU stay will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing upper abdominal surgeries

Exclusion Criteria:

* BMI above 40

  * allergy for drugs used
  * complicated cases
  * patient refusal
  * chronic opioid use
  * cognitive dysfunction
  * chronic kidney disease
* Liver failure
Cross Sectional Survey on the Burden, Impacts and Causes of Hepatitis C Virus (HCV) Outbreak in South West Region in Burkina Faso

This study investigates hepatitis C virus (HCV) outbreak in South West general population in Burkina Faso with three specific objectives: estimate HCV prevalence in South West Region general population in 2019; identify factors associated with recent HCV infection (in subjects younger than 20 years); and evaluate the pilot treatment strategy implemented by the national program for diagnosed cases during investigation.

A previous ANRS (French National Agency for Research on AIDS and Viral Hepatitis)12270 study supported by Burkina Faso's Minister of Health, used blood samples from the 2010 Demographic and Health Survey (DHS) to document the country's national and regional prevalences and highlighted a localized HCV epidemic in the Southwest Region with a prevalence of 13.2% which was 4 times higher than the national prevalence. This high prevalence of HCV was found in both adults and youth.

Given the particular epidemiological situation of the South-West region and the limits of the 2010 DHS, we aimed to carry out a thorough investigation of this HCV epidemic in the South-West region of Burkina Faso in order to control it.

A mixed methodology (quantitative and qualitative) will be used including: (i) a cross-sectional survey to estimate the prevalence of HCV infection in the South-West population in Burkina Faso; (ii) a case-control study among individuals less than 20 years of age to identify factors associated with current HCV transmission; (iii) a qualitative survey to provide additional information explaining the high prevalence of HCV infection (historical events, for example); (iv) a cohort study to evaluate a pilot treatment management strategy to be implemented by the national program in the South West Region

Eligibility Criteria:
Inclusion Criteria:

* To be a usual resident of the Burkina Faso South West region
* Express informed consent
Investigating Reduction of aCute heArt Failure Readmission With Lung UltraSound-preliminary Trial

In Switzerland 15% of discharged patients are readmitted within 30 days. Acute heart failure is the leading cause of hospital admission and one of the most frequent reasons for re-admission, mainly because of congestion-driven symptoms. Residual congestion is noted in 10%-15% of patients at discharge and is associated with an increased risk of re-admission and mortality. Lung ultrasound outperforms both chest X-ray and physical examination in detection of lung congestion. Several semiquantitative scanning protocols exist for quantifying congestion. The aim of this study is to compare for the first time two widely used lung ultrasound protocols, one exhaustive (28-points) and one simplified (8-points), in real-time settings. The focus is placed on reproducibility (expert-beginner interobserver concordance), feasibility (time consumption for images acquisition and interpretation) and performance (detection of B-lines clearing) of both scores. Semi-quantitative method is expected to have better feasibility with similar reproducibility and performance.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of acute heart failure on admission chart (primary or secondary diagnosis)
* Admission from the emergency room to a general internal medicine ward
* Presentation of acute heart failure according to European Society of Cardiology :
* Presence of ≥1 symptom or sign based on admission chart review and
* Raised value of N terminal-pro-brain natriuretic peptide (\>300 ng/l)

Exclusion Criteria:

* Interstitial lung disease, lung cancer or metastasis, acute respiratory distress syndrome, pulmonary contusion, previous lung surgery
* Inability or unwillingness to give consent
* Presence of oligo-anuric end stage renal disease
Providing Mental Health Precision Treatment

This research study is being conducted to understand if patients benefit from mobile health interventions while waiting for in-clinic mental health treatments, and to understand which patients receive the most benefit.

Initially, results-reporting was planned for 12-month data. However, following 6-week data collection, the participants received other care, so the decision was made to report on the 6-week data.

Eligibility Criteria:
Inclusion Criteria:

* Must have a scheduled mental health intake appointment at Michigan Medicine Outpatient Psychiatry or University Health Service at the University of Michigan
* Must have daily access to a smartphone version that is compatible with study activity trackers.
* Understands English to enable consent and use of the MyDataHelps app and app-based interventions
* Provide complete, updated contact information upon enrollment to the study
* Agree to be contacted by study staff during the study
* Willingness to keep study setup (devices, apps, settings) in required configuration for the duration of the study, and following instructions by study staff if required to update or re-achieve required configuration if required configuration has been lost (e.g., change of phone, app deletion)

Exclusion Criteria:

* Self-reported or medical record indication of a current eating disorder
* Scheduled outpatient mental health appointment is a pediatric appointment (even if age 18+)
* Wrist too large or too small to wear an Apple Watch or Fitbit comfortably (Note: bands that are shorter or longer than the standard will be made available to minimize this exclusion)
Addressing Anxiety and Stress for Healthier Eating in Teens

Project ASSET will explore the preliminary efficacy of interpersonal therapy, when compared with cognitive behavioral therapy, for reducing anxiety symptoms, preventing excess weight gain, and reducing cardio-metabolic risk in adolescent girls with above-average weight and elevated anxiety. As a pilot for a larger multi-site study, this trial will also test multi-site feasibility, acceptability, and intervention fidelity.

This study is a randomized controlled trial in which 40 adolescent girls aged 12-17 years-old with weight in the 75th percentile or higher for their age and sex, and elevated anxiety symptoms, will be randomly assigned to an IPT or CBT 12-week group intervention. Approximately 20 adolescent girls will be enrolled at each of two sites: Uniformed Services University (USU) and Colorado State University (CSU). After a screening and baseline assessment, participants will attend an individual meeting with the leaders of their assigned group to learn more about the group process and establish goals. They will then participate in the group program for 12 consecutive weeks. Each group will be led by a PhD-level clinical psychologist and a healthcare trainee. In-person and remote assessments, will be conducted at baseline, in the \~two weeks post-intervention (i.e., 12-week follow-up), and at 1, 2, and 3 years post-intervention. These assessments will consist of body measurements, blood draws for collection markers of metabolic functioning, and surveys and interviews of psychological and social functioning. At baseline, two weeks, and one year post-intervention, participants will also have a week-long period during which they will wear devices collecting activity and physiological data, and complete phone surveys assessing disinhibited eating behaviors, food craving, affect, cognitions, and avoidance behaviors.

Eligibility Criteria:
Participant Inclusion Criteria:

* 12-17-year-old adolescent girls
* BMI ≥ 75th percentile
* Anxiety symptoms: 32 or higher on State Trait Anxiety Inventory for Children-Trait Scale

Participant Exclusion Criteria:

* Any medical condition (as well as pregnancy or breastfeeding)
* Individuals who have any DSM psychiatric disorder that, in the opinion of the investigators, would impede competence or compliance or possibly hinder completion of the study
* Medication impacting mood or weight
* Psychotherapy
Effectiveness Of Therapy With A Thermal Water Nasal Aerosol In Children With Seasonal Allergic Rhinitis

The purpose of this study was to evaluate the effects of Ischia thermal waters nasal irrigation on allergic rhinitis and airway inflammation during the period of natural exposure to parietaria pollen in children with allergic rhinitis and intermittent asthma.

The study was conducted on the island of Ischia - Naples from April to June 2009, during the natural exposure period to parietaria pollen. The treatment started just before the pollen season, when all the children were asymptomatic, not treated with any drug and not affected by respiratory tract and systemic diseases. All the children were randomly divided into two homogeneous groups by sex and age. The first group has practiced crenotherapy with "hyper-mineral chloride sodium water" aerosol by nasal adapter for 15 days per month, for three consecutive months, at thermal spa services of Lacco Ameno, while the control group was treated, in the same period, daily, by a micronized nasal douche with 0.9% NaCl (isotonic) solution. Before the treatment (T0), at the end of the treatment (T1) and again 2 weeks after the end of the treatment (T2), all the children have performed spirometry (Pony FX Cosmed), and exhaled nitric oxide (FeNO) (NIOX MINO analyzer COSMED), to assess their airway inflammation. At the time of recruitment, the parents of the children were instructed to fill a specific diary-card (TSS) at home, to assess rhinitis symptoms and possible drug use during all 3 months of treatment. The parameters considered in the TSS were: nasal obstruction, sneezing, nasal discharge and itching. These symptoms were scored: 0 = symptom absent, 1 = mild (symptoms present but not annoying), 2 = moderate (frequent and offensive symptoms but do not interfere with sleep or normal activities) 3 = severe (symptoms that interfere with sleep or normal activities).

Every two weeks, at the end of each cycle of therapy the children underwent a general clinical control with nasal endoscopy, spirometry and monitoring the completion of diary cards and the possible use of drugs.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of moderate to severe allergic rhinitis.
* Children aged 6-14 year sensitized to parietaria.
* History of spring time symptoms.
* History of mild intermittent asthma.

Exclusion Criteria:

* Use of LABA, antihistamines, intranasal, bronchial or systemic corticosteroids, cromolyn sodium and leukotriene modifiers in the last 6 weeks.
* The presence of respiratory tract infection, persistent asthma, respiratory tract abnormalities or diseases.