cyrilzakka/clinical-trials huggingface dataset:
Integrative Mindfulness-Based Predictive Approach for Chronic Low Back Pain Treatment

This study will identify unique signatures that people have which can cause pain by evaluating biological, psychological, and social markers using artificial intelligence. These markers can be used to accurately predict the response of diverse individuals with chronic low back pain (cLBP) to Mindfulness-Based Stress Reduction. This will help enhance clinician decision-making and the targeted treatment of chronic pain.

The overall objective is to use a unique machine learning (ML) approach to determine the biomarker signature of persons undergoing mindfulness based stress reduction (MBSR) treatment for their chronic low back pain (cLBP). This signature will facilitate clinical prediction and monitoring of patient response to MBSR treatment.

The design of the study is a single-arm clinical trial of the evidence-based MBSR program for patients with cLBP.

UG3 Phase Overview. The first 24-months of the project will be dedicated to performing machine learning modeling to identify candidate predictive and monitoring markers of cLBP response to MBSR, prior to the full clinical trial in the UH3 phase. We will also refine our procedures such as recruitment and outcomes assessment with 50 persons during the UG3 phase.

UH3 Phase Overview. Biopsychosocial markers will be identified of the response of diverse cLBP patients to MBSR (N=300) from comprehensive pain assessment and biopsychosocial data, including pain intensity and pain interference, physical activity, sleep, and heart rate for a 6-month period. Data will be collected and used for training and testing ML models. The MBSR program is evidence-based and meets weekly in a group via Zoom for 8-weeks for 90 minutes per week. Measures to determine biomarkers will be obtained at baseline (T1), four-weeks (T2), program completion (T3), four months (T4), and six months (T5). The main outcome timepoint with be at six months (T5), which allows time for durability of effects to be determined. The PEG (Pain, Enjoyment, General activity), obtained through online self-report surveys is the main outcome measure. Secondary outcomes of physical and psychological function will be self-report and obtained online, or if the patient prefers, by telephone, and physical activity, sleep, and heart rate variability will be collected by Fitbit.

Eligibility Criteria:
Inclusion Criteria:

* Chronic low back pain, which is pain that persists for at least 3-months and has resulted in pain on at least half the days in the past 6 months
* Willing and able to provide online or telephone informed consent
* Speak English as the intervention manual is currently written in English

Exclusion Criteria:

* Red flags- recent (past month) worsening of pain, unexplained fever, unexplained weight loss
* Pregnancy
* Metastatic cancer
* Not a patient at a participating clinic or persons not planning to continue as a patient at a participating clinic for 6 or more months
Role of Mesh in Laparoscopic Sacropexy Surgical Techniques for the Treatment of Female Genital Prolapse

This study aims to determine the rate of recurrence of central pelvic organ prolapse in patients who have undergone surgery (sacropexy with and without mesh) for the same pathology.

There is a lack of data in the literature comparing sacroplexing with the use of mesh with sacroplexing performed without the use of mesh in terms of recurrence, improvement in symptoms, and restoration of normal pelvic organ prolapse relationships. The objective of this study is to determine the rate of recurrence of central pelvic organ prolapse in patients with a clinical diagnosis of genital prolapse stage ≥ 2 according to the POP-Q classification who underwent laparoscopic sacroplasty with mesh (group 1) and without mesh (group 2). The study may provide information on the impact of mesh in laparoscopic surgery for the correction of central pelvic organ prolapse.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Clinical diagnosis of genital prolapse stage ≥ 2 according to POP-Q classification
* Surgical treatment of laparoscopic sacropexy by mesh (group 1) and without (group 2) in female patients
* Acquisition of informed consent
* At least one follow-up evaluation at 24 months

Exclusion Criteria:

* Age \> 80 years
* Previous genital prolapse surgery
The Effect of a Nutritional Supplement on Post Prandial Glucose and Lipids in an Adult Population

The primary aim of this study is to evaluate the effect of a fibre rich health food drink on the post prandial glucose and triglyceride peak in healthy overweight adults with impaired fasting glucose (IFG). The study is randomised, stratified, double blind, two treatments, two period cross over study.


Eligibility Criteria:
Inclusion Criteria:

* Healthy overweight male and female participants
* Age 18-75 years
* BMI ≥25\<35 Kg/m2

Exclusion Criteria:

* Pregnancy/breast-feeding
* Allergy/Intolerance
* Anaemic participants: Hb \<10g/dL
* Diabetic participants: fasting blood glucose \>125 mg/dL
* Serum Aspartate Transaminase, Alkaline Phosphatase and Serum albumin level 3 times the upper limit of normal range
* Participants on other medications (lipid lowering drugs, oral hypoglycemics)
A Prospective Study to Examine the Effectiveness and Safety of Antivirals in Volunteers Who Receive Short-term Prophylaxis Against Pandemic Influenza

This aim of this project is to evaluate the efficacy of neuraminidase inhibitors as short-term prophylaxis against pandemic influenza infection in people who have close familial contact with the disease. The study is observational only. The primary measure used in this study will be the incidence of symptomatic pandemic influenza in patients receiving prophylaxis. Seroconversion to pandemic influenza, the incidence of adverse events and the relative effectiveness of oseltamivir and zanamivir prophylaxis will also be examined. This project will commence upon pandemic influenza being declared in Australia, Hong Kong or Singapore. Data will be analysed as quickly as possible to help inform the continued use of neuraminidase inhibitor therapy as a cornerstone of the public health agency response to pandemic influenza.

The aim of this study is to

1. Describe the effectiveness of short-term prophylaxis against symptomatic pandemic influenza infection
2. Describe the safety of short-term prophylaxis
3. Describe the seroconversion rate against pandemic influenza among recipients of short-term prophylaxis

The study is an open label prospective cohort study. Contact group members of people with diagnosed influenza who are recommended to receive NA inhibitor prophylaxis for short periods of time will be enrolled following provision of informed consent. Each episode of short-term prophylaxis will be recorded separately.

By design it is hoped that volunteers in this study who develop symptoms and signs of pandemic influenza infection will be enrolled in the Index Case (PIPET A) protocol with follow-up as required.

Eligibility Criteria:
Inclusion Criteria:

* Provision of written informed consent
* Intention to commence or have commenced short-term prophylaxis with a neuraminidase inhibitor in individuals who have been exposed to the pandemic virus

Exclusion Criteria:

* none
Digital Mammography: Computer-Aided Breast Cancer Diagnosis

The purpose of this study is to develop computer programs to assist radiologists in finding breast cancer on mammograms and to compare the computer's accuracy of detecting cancers on direct digital and film mammograms.

To develop a computer-aided diagnosis (CAD) system for full field digital mammography (FFDM) using advanced computer vision techniques and to evaluate the effects of CAD on interpretation of digital mammograms (DMs). This system will assist radiologists with the four most important areas in mammographic interpretation: (1) detection of masses, (2) classification of masses, (3) detection of microcalcifications, (4) classification of microcalcifications. The proposed approach is distinctly different from previous approaches in that image information from two-view and bilateral mammograms will be fused with that from the single-view mammogram to improve lesion detection and characterization.

Eligibility Criteria:
Inclusion Criteria:

* Females who have been scheduled for mammographic exams.
* Females who have been recommended for work-up or biopsy due to a suspicious finding on their mammogram.
* Females who can give informed consent.

Exclusion Criteria:

* No subject under 18 years of age
Mask Usage and Exercise During the COVİD-19 Pandemic

To determine the effect of using mask during exercise on exercise capacity and values measured before exercise (heart rate, blood pressure, peripheral oxygen saturation (SpO2), fatigue, severity of dyspnea, etc.). To investigate the haemodynamic effects (heart rate, blood pressure, peripheral oxygen saturation (SpO2), fatigue, dyspnea severity, etc.) of the mask, which entered daily life during the epidemic period and which requires long-term use, and examine the effect on hemodynamic stress.

Surgical masks are frequently used after the necessity to use a mask in the community.The effects of technologically well-designed training masks used in athletes have been shown on hypoxia and heart rate responses during exercise, but there are no studies examining the exercise capacity and hemodynamic responses given to exercise in healthy normal individuals.This study is planned to evaluate the effects of the use of surgical masks that are widespread in the community due to pandemic on the exercise capacity and exercise responses (heart rate, blood pressure, peripheral oxygen saturation, fatigue).

Exercise tests will be carried out for each individual randomly, twice with a mask and without a mask. The materials used before and after each exercise test will be sterilized. During the exercise test, individual antibacterial filters will be used for each person.Bruce protocol will be used to determine exercise capacity.

Eligibility Criteria:
Inclusion Criteria:

* Volunteering to be included in the research,
* Being between the ages of 18-65,
* Having physical fitness to do exercise tests,
* Having a cognitive function that will allow active participation in the exercise test.
* No chronic illness.

Exclusion Criteria:

* Not to volunteer to participate in the research,
* Having any mental or physical condition that impedes performing exercise tests,
* Having any of the symptoms of COVID-19,
* Having been diagnosed with COVID-19 before,
* Having a history of contact with COVID-19 patient
* Having a cardiac, neurological, orthopedic and respiratory disease
* Use of assistive devices while walking
Radioiodine-avid Bone Metastases From Thyroid Cancer Without Structural Abnormality

Bone radioiodine (RAI) uptake without structural abnormality in thyroid cancer (TC) patients may be related to false positive or to microscopic foci of metastatic tissue. In such cases, outcome is reported to be excellent.

Indeed, Robenshtok et al. reported a serie of patients with RAI-avid bone metastases of TC without structural abnormality on imaging studies who have more favorable long-term prognosis than those harbouring structurally visible bone metastases and do not undergo skeletal-related complications.

The investigators report the case of Mrs D., who had been operated for a pathologic tumor stage 3: pT3(m) poorly differentiated TC at the age of 43. The first post-therapeutic whole body scan revealed 3 foci of bone uptake (right clavicle, L2, L3). The elevated level of thyroglobulin (157ng/mL) favoured the hypothesis of bone metastases despite the absence of any structural lesion on CT and MRI. She received 7 courses of radioiodine therapy. The right clavicle RAI uptake persisted, and subsequent CT disclosed an osteolytic lesion which was treated by radiofrequency and external beam radiation. Twenty-five years after the diagnosis, she has a persistent morphological disease with a 30x8mm progressive lesion on the right clavicle, for which surgery is planned.

The aim of the present study is to describe the natural history and evolution of radioiodine avid bone metastases from thyroid cancer without structural abnormalities and to identify prognosis factors.


Eligibility Criteria:
Inclusion Criteria:

* Differentiated thyroid cancer
* Ablation therapy with post dose scintigraphy
* At least one radioiodine bone uptake without structural correlation on high-resolution imaging

Exclusion Criteria:

* A single radio iodine bone uptake with structural correlation on imaging
* Diagnosis of bone metastasis after a skeletal related event including spinal cord compression, pathological fracture, need for external beam radiation, surgery to bone, or development of hypercalcemia of malignancy
* Follow up less than 6 months
* Missing data in medical record
Pharmacokinetics and Immunogenicity of the First Doses of PEG-Asparaginase -An ALLTogether Pilot Study

Acute lymphoblastic leukemia (ALL) is the most common malignant disease in childhood. Survival rates exceed 90% in children and 75% in adults (aged 18-45 years). During the induction period Asparaginase is an indispensable part of the multiagent treatment, but is often associated with hypersensitivity, either with clinical allergy or silent inactivation. In both cases, Asparaginase is inactivated. It is well known that truncation of Asparaginase treatment due to inactivation reduces survival. To approach understanding Asparaginase dynamics and hypersensitivity in ALL patients it is important to examine the pharmacokinetics of Asparaginase.

The aim of this study is to identify serological parameters for prediction of hypersensitivity reaction after the first doses of PEG-Asparaginase given intravenously on the ALLTogether protocol.

Asp enzyme activity is measurable in plasma, and trough levels above 100 IU/l secure effect. Patients, who have their treatment truncated, have inferior outcome. For many years prolonged Asp treatment for 30 weeks has been part of most protocols worldwide, but a recent Nordic randomized study showed that less asparaginase (8 doses vs 15 doses intramuscularly (IM)) results in the same disease-free survival and significant less toxicity in the less intensive treatment arm (6).

Accordingly, in the current Western European protocol (ALLTogether) less Asp is now given. The Nordic Countries participate in this protocol.

Unlike in the previous Nordic protocol, NOPHO ALL2008, in ALLTogether Asp will be initiated early during induction (day 4 compared to day 30) and given intravenously (IV) and not IM. In February 2017 it was approved by the NOPHO Board to do more extensive pharmacokinetic studies of IM administered PEG-asparaginase, as it has not been shown if IM or IV is preferably in respect to minimizing the incidence of hypersensitivity. Most study groups in the world use IV administration, thus NOPHO has a unique chance to illuminate inactivation after IM administration, also in adult patients. Other groups have not published this.

For \>50% of the patients in ALLTogether, the induction therapy has been reduced from 4 drugs to 3 drugs. This emphasizes the importance of optimal treatment from the beginning. Therapeutic Drug Monitoring (TDM) will identify patients without activity in order to change Asp preparation. Additional sampling close after the first dose of PEG-Asp is expected to identify these patients earlier, providing an opportunity to optimize their treatment for better disease-free survival.

The aim of this study is to identify serological parameters for prediction of hypersensitivity reaction after the first dose of PEG-Asp given IV on the ALLTogether protocol.

Eligibility Criteria:
Inclusion Criteria:

* Treated for acute lymphoblastic leukemia (ALL) on the ALL2GETHER pilot protocol

Exclusion Criteria:

* none
Study to Determine if the Flu Vaccine Increases the Risk of Muscle Damage in Participants Taking Drugs That Block Certain Proteins Made by Some Types of Immune System Cells

A retrospective, observational study conducted on cancer patients receiving a drug that blocks certain proteins made by some types of immune system cells


Eligibility Criteria:
Inclusion Criteria:

* Treatment with a checkpoint inhibitor (CPI)
* Age greater than or equal to 18 years on date of first claim for a CPI
* ICD-9 or ICD-10 code for a malignancy within 180 days prior to the first claim for any CPI, and
* Greater than or equal to 180 days of continuous pharmaceutical and medical benefit enrollment in the database prior to the first claim for any CPI

Exclusion Criteria:

* Less than 18 years of age

Other protocol defined inclusion/exclusion criteria could apply
Studies of the Ocular Complications of AIDS (SOCA)--Cytomegalovirus Retinitis Retreatment Trial (CRRT)

To compare the relative merits of three therapeutic regimens in patients with AIDS and CMV retinitis who have been previously treated but whose retinitis either is nonresponsive or has relapsed. These three therapeutic regimens were (1) foscarnet, (2) high-dose ganciclovir, and (3) combination foscarnet and ganciclovir.

To compare two treatment strategies in patients with relapsed or nonresponsive CMV retinitis: (1) continuing the same anti-CMV drug or (2) switching to the alternate drug.

CMV retinitis is the most common intraocular infection in patients with AIDS and is estimated to affect 35 to 40 percent of patients with AIDS. Untreated CMV retinitis is a progressive disorder, the end result of which is total retinal destruction and blindness. At the time of this trial, drugs approved by the United States Food and Drug Administration (FDA) for the treatment of CMV retinitis were ganciclovir (Cytovene) and foscarnet (Foscavir). Although most retinitis responds well to initial therapy with systemically administered drugs, given enough time, nearly all patients will suffer a relapse of the retinitis. Relapsed retinitis generally responds to reinduction and maintenance therapy, but the interval between successive relapses progressively shortens. The CRRT addressed the issue of the management of relapsed CMV retinitis.

The CRRT was a multicenter, randomized, controlled clinical trial comparing three regimens in patients with relapsed retinitis. Patients with AIDS and CMV retinitis that had relapsed or was nonresponsive to initial therapy were randomized to one of three regimens: (1) intravenous foscarnet reinduction at 90 mg/kg twice daily for 2 weeks, followed by maintenance therapy at 120 mg/kg/day; (2) intravenous ganciclovir reinduction at 5 mg/kg twice daily for 2 weeks followed by maintenance at 10 mg/kg/day; and (3) combination therapy, wherein patients continued their previous therapy and were reinduced with the second drug and then placed on maintenance therapy with foscarnet at 90 mg/kg/day and ganciclovir at 5 mg/kg/day.

Eligibility Criteria:
inclusion criteria: Males and females eligible for the CRRT must have been age 18 years or older and have had AIDS and CMV retinitis. They must have had active CMV despite a minimum of 28 days of previous treatment with an anti-CMV drug. Furthermore, they must have had an absolute neutrophil count greater than or equal to 500 cells/µL, platelet count greater than or equal to 20,000 cells/µL, and a serum creatinine \< 2.5 mg/dL in order to tolerate the drug regimens.

exclusion criteria: history of intolerance to ganciclovir or foscarnet, history of therapy involving the combination of foscarnet and ganciclovir, unwillingness to practice appropriate birth control, active drug or alcohol abuse, media opacity, retinal detachment not scheduled for surgical repair
c9,t11-CLA in Children and Adolescents With Allergic Asthma

The study was performed to investigate the effects of a dietary intervention with c9,t11-CLA on clinical and immunological parameters in children and adolescents with allergic bronchial asthma.

In-vitro and animal studies strongly suggest that c9,t11-CLA reduces inflammatory processes in asthma-models. Aim of this study was to determine possible beneficial effects of orally administered c9,t11-CLA in children and adolescents with allergic bronchial asthma.

Thirty subjects (14 girls, 16 boys, age 6-18 years) were recruited from regular patients in the Clinic for Pediatric Allergology of the Friedrich Schiller University Jena. Informed consent was obtained from all participants/parents. 29 subjects completed the study.

The study was designed as a randomized and placebo-controlled study. After a 1-week run-in period to ascertain the current state of disease and categorization of allergic sensitization by RAST, the participants were randomized and evenly distributed to receive either 3 g/d of an esterified CLA preparation free of t10,c12-CLA (75% c9,t11-CLA, 87% purity) or 3 g/d of a placebo oil mixed in 100 g portions of milk fat-free yoghurt for 12 weeks. The yoghurt was freshly prepared and distributed in frequent intervals.

At the beginning and at the end of the study, lung function parameters were assessed by whole body plethysmography, and venous blood and 24h-urine samples were collected for further analyses. Throughout the entire study, the participants daily recorded their peak-flow data and kept protocol about their symptoms and drug usage.

Eligibility Criteria:
Inclusion Criteria:

* age 6-18 years
* doctor-diagnosed bronchial asthma
* allergic sensitization (house dust mite, grass pollen)
* willingness to use only the recommended drugs
* competence regarding the daily documentation of peak-flow data and symptoms

Exclusion Criteria:

* SIT within the last 2 years
* primary and secondary immune deficiency
* usage of systemic corticoids
* intolerance against milk protein
* alcohol and drug abuse
Statin Immune Study

Statins are widely used drugs to treat hypercholesterolaemia. In general, they are very safe drugs. However, up to one third of statin users can experience muscle symptoms, which are most commonly mild without any conventional laboratory signs of muscle damage. However, these muscle symptoms can often lead to poor compliance to the cholesterol-lowering therapy, reducing its effectiveness. Recent data has highlighted the potential role of immune system in development of statin-induced muscle pain. Variation in the LILRB5 gene has been associated with statin intolerance. We aim to investigate the impact of LILRB5 genetic variability in tolerability and immune response to atorvastatin in healthy volunteers.

The study is being undertaken at the Tayside Institute for Cardiovascular Research (TICR) in Ninewells Hospital, Dundee. We will recruit participants who have donated a sample to GoSHARE study. The participants will be healthy, and recruited according to their genotype of LILRB5 (information available from GoSHARE). The volunteers will then enter a randomised cross-over study with two treatment periods. During treatment period one, all participants will be commenced on atorvastatin or placebo (a dummy drug). Before and at the end of the treatment period, blood and urine samples will be taken and a muscle symptoms questionnaire will be completed to assess the tolerability and immune response to the study drug exposure. After four weeks, the study drug is stopped for a washout period of three weeks before cross-over commences. Thereafter, during treatment period two, the alternate study drug will be started, and tolerability will be assessed similar to that in period one. The study will last approximately 11 weeks. The volunteers have a total of 5 visits to the TICR.


Eligibility Criteria:
Inclusion Criteria:

* Age 40-69 years
* Statin-naïve
* White European
* Healthy
* Acceptable laboratory test results

Exclusion Criteria:

* Significant disease
* Regular drug therapy
* Recent involvement (\<30 days) in a CTIMP
* Inability/unwillingness to comply with the protocol
* Carry the rare variant of the CKM polymorphism rs11559024
* Unable to consent
* Woman of childbearing potential (i.e. premenopausal female capable of becoming pregnant)