cyrilzakka/clinical-trials huggingface dataset:
Child of Urban Poverty Iron Project (CUPIP) - A Pilot Study

The first 1,000 days of life are critical periods for brain development. Proper nutrition lays the foundation for optimal growth, health, and neurodevelopment across the lifespan. Poor nutrition in this vulnerable period has irreversible consequences, including stunting, susceptibility to sickness, reduced school performance and productivity, and impaired intellectual and social development. UNICEF reported in 2018 that among the low cost flat residents in urban areas of the Klang Valley, 15% of children under 5 years old were stunted, 22% underweight, and 23% either overweight or obese.

Will a micronutrient supplementation program improve the growth and iron status of children aged 6 months to 5 years staying in Lembah Subang? Children will be randomized into treatment and control groups. Treatment groups will receive dietary micronutrient supplementation packets. Measurements of height and weight and iron status will be taken at baseline and 4 months later.

This is a pilot study in a single-centre, using a single-blind, two-parallel group, randomized trial conducted amongst children aged 6 months to 5 years residing at PPR Lembah Subang, located in the state of Selangor, Malaysia between October 2019 and February 2020 (4 months). The participants were randomly assigned in a 3:2 treatment-to-control allocation to receive, in addition to the baseline deworming treatment, either daily micronutrient packets for 4 months (intervention arm) or no micronutrient supplementation (control group). This residency area comprises a local population with mixed ethnic makeup and poor socioeconomic status (majority are B40).

We distributed flyers, posters, and leaflets with the help of the community mothers in PPR communities to encourage participation. Registration, informed consent and anthropometric measurements, dietary logs and blood drawn for iron status were taken prior to randomization. All children received a baseline deworming treatment at this point.

The treatment group received baseline deworming medications, a 4-month supply of daily micronutrient supplementation and a compliance monitoring log. The control group only received similar baseline deworming medications without any daily micronutrient supplementation. Only the research investigators and outcome assessors were masked to the treatment status whilst the participants and interventionists research investigators were aware of the assigned intervention.

Primary endpoints assessed in this study are changes in serum ferritin and hemoglobin levels at 0 and 4 months after interventions. The secondary endpoints are changes in age-and-sex standardized height and weight percentile scores at 0 and 4 months after micronutrient supplementation.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 6 months to 5 years living in PPR Lembah Subang

Exclusion Criteria:

* Ex-premature babies and children with congenital abnormalities resulting in gross impairment
* Children whose caregiver did not consent to participation
Strongest Predictors of a Positive Outcome After Physiotherapy for Knee Osteoarthritis

Individuals with painful knee osteoarthritis (OA) experience restricted physical function. Few previous studies have investigated comprehensive sets of constructs and tests to investigate physical function in these patients. Most single studies of knee OA patients show limited scope for explaining physical function in the perspective of WHO's International Classification of Functioning, Disability and Health (ICF) 3 levels: Body functions (the bodily level), Activities (individual level), and Participation (societal level). On the bodily level there is limited case-control knowledge on muscle strength beyond the knee and endurance-strength in general. On the activity level, there is similar limitation of biomechanical bodily features in stair climbing. On the participation level the situation is similar for objective performance. Measures are needed that inter-relate all three levels of ICF. These should also include well discriminating tests e.g. knee strength, walking, and activities of daily life (ADL), as well as both objective and subjective measures.

The purpose of this study is to explore mechanisms that can explain physical function in patients with knee OA in primary care. The study's main and primary goal is to quantify which baseline factors and change scores are the strongest predictors of a positive treatment outcome in terms of patients' global perceived change after physiotherapy. Secondary research question is: which factors are the strongest predictors of a positive outcome of physiotherapy in knee OA, in terms of pain intensity, patient specific functional scale, and function in daily living?


Eligibility Criteria:
Inclusion Criteria:

1. Clinical and radiological osteoarthritis of the knee and referred to physiotherapists.
2. Symptomatic daily during the last month.
3. Symptomatic for more than one year.
4. Able to walk up and down a flight of 10 stairs with or without walking aids.
5. Able to walk 3 stairs up and down without walking aids.
6. Understand Norwegian orally and in writing.
7. Body mass index below 35.

Exclusion Criteria:

1. Neurological, rheumatic, orthopedic, or respiratory diagnosis, other than osteoarthritis of the knee which can negatively affect the walking ability, balance or pain.
2. Body mass index above or equal to 35.
3. Fracture of the femur or shank, or arthroscopic surgery in the osteoarthritic knee.
4. Chronic generalized pain (American College of Rheumatology Criteria, 2010).
5. Inability to understand Norwegian language.
Writing About Disease: Effect on Rehabilitation?

Therapeutic writing about one's emotions has been described previously (J Pennebaker: Emotions, disclosure and health. Am Psychol. Assoc 1995). The present project will compare the effects (if any) of writing about the emotional versus the physical consequences of lung disease on anxiety, perceived quality of life, and perceived health status.

Chronic obstructive pulmonary disease (COPD) patients (age 35-70) and asthma patients (age 20-60) referred to a 4 weeks inpatient rehabilitation program - who agree to participate in the project - are randomly assigned to one of three conditions:

* Writing about emotional consequences of their disease before the program starts
* Writing about physical consequences of their disease before the program starts
* Not writing

All patients are measured (completing questionnaires at home) on: perceived quality of life, perceived health status and trait anxiety - 2 weeks before the program, 2 weeks after the program and 6 months after the program. FEV1 and 6 min walking distance are measured at the beginning and by the end of the program.

In addition to questionnaires, all patients are asked to:

* Write in their own words ( 2 weeks after) to evaluate their stay at the rehabilitation clinic; and
* Write in their own words (6 months after) about how the disease affects their life at that point.

Both quantitative and qualitative data will be used for analysis purposes.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of COPD (age between 35 and 70)
* Clinical diagnosis of asthma (age between 20 and 60)
Ursodeoxycholic Acid Prevents Total Parenteral Nutrition Cholestasis

This study aims to confirm whether the preventive use of ursodeoxycholic acid on the 5th day after birth in preterm infants who started parenteral nutrition therapy can reduce the occurrence of enteral nutrition-related cholestasis in preterm infants. This study examined the safety and efficacy of ursodeoxycholic acid (UDCA) in preventing Cholestasis Associated with Total Parenteral Nutrition in preterm infants.

Investigators compared oral administration of UDCA prophylaxis with no prophylaxis in a randomized, open-label, proof-of-concept trial in preterm neonates with PN therapy.

Eligibility Criteria:
Inclusion Criteria:

1. admission to the hospital within 24 hours after birth
2. gestational ages:28-32 weeks
3. requiring TPN during the first days of life

Exclusion Criteria:

1. major congenital abnormalities, chromosomal abnormality congenital intrauterine infection, genetic metabolic diseases structural liver abnormality
2. surgical treatment was taken during hospitalization
3. with severe symptoms of digestive system disease before TPN
4. incompletion or withdrawal of treatment during hospitalization
ACCELERATE Study - A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Combination With COPEGUS (Ribavirin) in Interferon-Naive Patients With Chronic Hepatitis C (CHC) Infection.

This study will evaluate the efficacy and safety of different durations of treatment with PEGASYS combined with ribavirin in patients with CHC genotype 2 or 3 infection who have never previously received interferon (IFN) therapy. The anticipated time on study treatment is 3-12 months and the target sample size is 500+ individuals.


Eligibility Criteria:
Inclusion Criteria:

* patients \>=18 years of age;
* CHC infection (genotype 2 or 3);
* liver biopsy (in \<24 calendar months of first dose), with results consistent with CHC infection;
* use of 2 forms of contraception during study and 6 months after the study in both men and women.

Exclusion Criteria:

* women who are pregnant or breastfeeding;
* male partners of women who are pregnant;
* conditions associated with decompensated liver disease;
* other forms of liver disease, including liver cancer;
* human immunodeficiency virus infection;
* previous treatment with an IFN, pegylated IFN, ribavirin, viramidine, levovirin, or amantadine.
Molecular Markers of Chemosensitivity for Bladder Cancer

The purpose of this study is to try to figure out some bio-markers of chemosensitivity for adjuvant chemotherapy for bladder cancer.

Figure out some bio-markers of chemosensitivity for adjuvant chemotherapy for bladder cancer.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female, 18 years of age or older, estimated life expectancy ≥ 6 months.
2. .Gone through standardize radical cystectomy and pelvic lymphadenectomy or inoperable.
3. Transitional cell carcinoma of bladder, stage pT3N0M0,T2N1M0-T3-4N1-2M1.Transitional cell carcinoma may be with or without squamous cell carcinoma and/or adenocarcinoma components.
4. Electrocorticography(ECOG) performance status 0-2.
5. Blood routine:Absolute neutrophil count (ANC) ≥ 1500/μL,White blood cell count ≥ 3000/μLPlatelets ≥ 100,000/μL,Hemoglobin ≥ 10.0 g/dL,
6. Total serum bilirubin≤ 1.5 x upper limit of normal (ULN).Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase(SGOT)) and serum alanine transaminase (ALT; serum glutamic pyruvic transaminase (SGPT)) ≤ 2.5 x upper limit of normal (ULN).
7. Creatinine clearance rate,Ccr ≥ 60%
8. ECG：no arrhythmias, no myocardial infarction. Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrollment.

Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests,and other study procedures.

Exclusion Criteria:

1. Past history of systemic chemotherapy
2. Serious heart and lung dysfunction.
3. Associated with central or peripheral neuropathy greater than 2 grade.
PMMHRI - Familial Hypercholesterolemia Registry

The registry is maintained at the Regional Centre for Rare Diseases, established in 2016, within Polish Mother's Memorial Hospital Research Institute. This facility diagnoses and treats over 80 distinct rare diseases in patients from across the country, including those with phenotypically or genetically confirmed familial hypercholesterolemia (FH).

All consecutive patients diagnosed with FH, including both children and adults, are being enrolled from December 2018 to May 2024. Each patient receives a consultation with a clinical geneticist and a dietitian, who provide recommendations for cascade screening among family members and promote a healthy and balanced diet. The study includes all index cases, with children also serving as index cases.

The PMMHRI FH registry is managed by physicians from the RCRD, who exclusively make all diagnostic and treatment decisions. The purpose of the registry is to investigate the clinical characteristics, diagnosis, management, achievement of therapeutic goals, and outcomes of FH patients. Inclusion criteria are based on phenotypic or genetic diagnosis of FH. Phenotypic diagnosis is conducted using the Dutch Lipid Clinic Network criteria for adults, and the Simon Broome criteria for children. During the baseline visit, comprehensive data collection includes all available lipidogram results, aiming to obtain naive LDL-C values, highest values, and treated values. All data collected during the enrollment period are included in the study.

Eligibility Criteria:
Inclusion Criteria:

* FH diagnosis

Exclusion Criteria:

-
Evaluation of Autonomic Cardiac Function in Patients With CRPS

To evaluate the autonomic cardiac function in patients with complex regional pain syndrome

Tilt table testing in patients with complex regional pain syndrome: Effects on heart rate variability and baroreceptor sensitivity.

Primary outcome parameter: Autonomic cardiac function

Eligibility Criteria:
Inclusion Criteria:

* Age: 18 or older.
* Pain \> 3 months.
* Diagnosed with CPRS acc. to diagnostic research criteria (Harder et al., 2005).
* Inclusion of healthy subjects: age-, gender-, and BMI-matched.

Exclusion Criteria:

* Other significant disease affecting the parameters measured, including cardiovascular disease.
* Treatment with anticholinergics, sympathomimetics and parasympathomimetics, and alpha- and beta-adrenergics.
Effectiveness of Massage Therapy With Active Component and Therapeutic Exercise in Cervical Pain

It is an interventional study that proves the eficacy of the manual therapy with active manual therapy and combined with exercise in cervical pain.

The study will be divided in two different groups:

* A control group (group A) : they will receive a treatment with manual therapy and physical exercise.
* An experimental group (group B) : they will receive the previous treatment, but also the pacient's do active muscle active contraction.

The exercise is compound by a home program of several exercises with diferent difficulties.

The contraction will consist on a combination of concentric and isometric work. being the patient's pain threshold the one that will guide us to the choice of the predominance of concentric or isometric contraction . Both groups will be joined by a five-minute work on pain education.

Eligibility Criteria:
Inclusion Criteria:

* accept to participate in the study, through informed consent
* subjects with chronic nonspecific neck pain lasting equal to or more than 3 months

Exclusion Criteria:

* Present neck pain caused by serious pathology such as: inflammatory, congenital, infectious, metabolic and neoplastic diseases.
* Cervical pathology of traumatic origin with less than 6 months of evolution.
* Rheumatic diseases.
* Neck pain with neurological signs such as: radiculopathy and myelopathy.
* Previous surgery of the cervical spine.
* Pregnancy.
* Have received physiotherapeutic treatment in the cervical region during the month prior to the inclusion of the study.
* Have the intention of receiving other physiotherapeutic treatments different from the one proposed during the study period.
* Present serious mental disorders.
Effect of Maolactin™ FMR on Exercise Recovery, Inflammation and Muscle Comfort in an Otherwise Healthy Population

This is a double blind, randomised, placebo-controlled, parallel-group trial to evaluate the effect of Maolactin FMR supplementation on chronic inflammation, mobility and muscle and joint pain in an otherwise healthy population of adults 45-65 years old over 14 weeks with 12 weeks supplementation.

This is PART B of the study.


Eligibility Criteria:
Inclusion Criteria:

* Adults 45-65 years old
* Generally healthy
* BMI 25.0 - 35.0 kg/m2
* C-reactive protein (CRP) equal to or greater than 2.0 mg/L
* Feel pain or discomfort in joints/muscle for at least 3 months
* Able to provide informed consent
* Agree not to change current diet and/or exercise frequency or intensity during study period
* Agree to not participate in another clinical trial while enrolled in this trial

Exclusion Criteria:

* Serious illness(1) e.g., mood disorders such as depression, anxiety or bipolar disorder, neurological disorders such as MS, kidney disease, liver disease or heart conditions
* Unstable illness(2) e.g., diabetes and thyroid gland dysfunction
* Unstable intake of any medication or supplement(3)
* Acute injuries on reporting area
* Current malignancy (excluding Basal Cell Carcinoma) or chemotherapy or radiotherapy treatment for malignancy within the previous 2 years
* Currently taking Coumadin (Warfarin), Heparin, Dalteparin, Enoxaparin or other anticoagulation therapy including low dose aspirin
* Receiving medications known to affect inflammation such as steroids
* Active smokers, nicotine use or drug (prescription or illegal substances) abuse
* Chronic past and/or current alcohol use (\>21 alcoholic drinks per week)
* Pregnant or lactating women
* Allergic to any of the ingredients in active or placebo formula
* Participants who are currently participating in any other clinical trial or who have participated in any other clinical trial during the past 1 month
* Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion

  1. A serious illness is a condition that carries a risk of mortality, negatively impacts quality of life and daily function and/or is burdensome in symptoms and/or treatments.
  2. An unstable illness is any illness that is currently not being treated with a stable dose of medication or is fluctuating in severity.
  3. An unstable intake is any dose that has changed by more than 10% of the previous dose in the past 4-weeks
Safety of Ertapenem in Beta-lactam Allergic Patients.

The purpose of this study is to assess cross-reactivity and tolerability of ertapenem in patients with IgE-mediated allergy to at least one beta-lactam molecule.

Ertapenem is a new carbapenem, stable to dehydropeptidase which has a broad antibacterial activity. Ertapenem exhibits a bactericidal mode of action and it has a long half-life of 4.5 hours; for this reason it can be developed as a single daily dose carbapenem.

In literature, no cases of IgE-mediated allergy to ertapenem have been described until now. However, a single study put in evidence a 47% rate of cross-reactivity between imipenem-cilastatin and beta-lactams in a group of patients affected by IgE-mediated allergy to these drugs. For this reason carbapenem administration to beta-lactam allergic patients has always been considered potentially harmful. Other studies reported lower cross-reactivity rates (from 7 to 11%) between imipenem-cilastatin and beta-lactams but patients of these studies did not undergo any allergy testing in order to demonstrate the pathogenesis of the reactions.

Recent studies put in evidence that imipenem has a very low cross-reactivity rate with other beta-lactams and they have a very good tolerability among patients with IgE-mediated allergy to beta-lactams: Romano et al. found a cross-reactivity rate of 0.9% between imipenem and penicillins in 112 penicillin-allergic patients (mean age 44.56 ± 15.66 ys.); Atanasković-Marković et al. found a cross-reactivity rate of 0.8% in 124 paediatric patients (age range 3-14 ys.) between imipenem and penicillins. In both groups imipenem was well tolerated by patients with negative allergy testing.

Meropenem showed to have a good tolerability too in penicillin allergic patients: Romano et al. found a cross-reactivity rate of 0.9% between penicillins and meropenem in penicillin-allergic patients (mean age 47.83 ± 15.8); Atanasković-Marković et al. found a cross-reactivity rate of 0.8% in 109 paediatric patients (age range 3-14 ys.) between meropenem and penicillins. In both groups meropenem was well tolerated by patients with negative allergy testing.

No data regarding the cross-reactivity of ertapenem with other beta-lactams and its tolerability among patients with IgE-mediated allergy beta-lactams are available in literature.

Aim of the study On the basis of those data, we decided to investigate the cross-reactivity of ertapenem with other beta-lactams in patients suffering from IgE-mediated allergy to at least one beta-lactam molecule and its tolerability in a group of a patients with negative allergy testing with ertapenem.

Eligibility Criteria:
Inclusion Criteria:

* IgE-mediated allergy to at least one beta-lactam molecule

Exclusion Criteria:

* positive allergy testing to ertapenem
* chronic diseases
* treatment with beta-blockers
* pregnancy
The Effects of Different Clonidine Concentrations on Axillary Brachial Plexus Block With 1,5% Lidocaine

The purpose of this study is to determine whether different clonidine concentration on axillary brachial plexus block with 1,5% lidocaine for upper limb surgery may influence the sensory and motor block onset time and duration, postoperative analgesia duration, postoperative pain intensity

Brachial plexus blocks are frequently used in surgical procedures involving the upper limb because they facilitate surgical anaesthesia, muscle relaxation and post-operative analgesics.

Various drugs are used to supplement local anaesthetics during brachial plexus block. Many studies in the literature show that clonidine, which is an alpha-2 agonist, prolongs the length of anesthesia and post-operative analgesia.4,5 However, clonidine's side effects-such as hypotension, bradycardia and sedation can limit its use.

There are no studies comparing different clonidine concentrations on the axillary brachial block, so the hypothesis of the present study was that different clonidine concentrations and LA volumes may influence the anaesthesia and analgesia quality on this type of regional block.

Eligibility Criteria:
Inclusion Criteria:

* both genders,
* over 18 years old,
* American Society of Anesthesiologists (ASA) 1 to 3

Exclusion Criteria:

* patients with chronic use of analgesics and non-steroidal anti-inflammatories drugs,
* pregnant,
* with infection at the puncture site,
* coagulopathies or intolerance to drugs used in the study
Percutaneous Cementoplasty With or Without Screw Fixation

Bone pathologies such as fragility fractures and neoplastic bone lesions are frequently encountered in rheumatology. When these lesions affect the pelvis, they are responsible both for pain that is sometimes very disabling, but also for significant functional disorders due to their location.

Different methods may be used to treat these lesions. The current challenge is to use less and less invasive techniques such as radio-guided cementoplasty to be able to treat all types of people, especially the most fragile. Among the elderly, the prevalence of these bone pathologies continues to increase due to the aging of the population and the improvement of diagnostic means.

The aim of this study is to retrospectively evaluate the outcome of cementoplasty of the pelvis in people aged 80 and over suffering from osteoporotic fractures or neoplastic lesions of the bony pelvis AND to assess the feasibility, safety and efficiency of this treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients with lesion of the bony pelvis treated by percutaneous cementoplasty with or without screw fixation at university hospital center of Saint-Etienne between January 1st 2012 and February 28th 2023

Exclusion Criteria:

* Other interventional treatment at the same time and at the same location
Comparison of Once Daily Versus 8 Hour Dosing of Gentamicin for the Treatment of Intrapartum Chorioamnionitis

To compare once daily versus 8 hour dosing of gentamicin for the treatment of chorioamnionitis.


Eligibility Criteria:
Inclusion Criteria:

- clinical diagnosis of chorioamnionitis

Exclusion Criteria:

- maternal renal disease, intrauterine fetal death, allergy to gentamicin