cyrilzakka/clinical-trials huggingface dataset:
Effects of Physical Activity Counseling in Patients With Adolescent Idiopathic Scoliosis

Scoliosis is a three-dimensional deformity of the spine of unknown etiology and is clinically defined as 10° or more lateral curvature of the spine. Although there are different types of scoliosis, the most common type is adolescent idiopathic scoliosis (AIS), which starts at the age of 10. AIS can affect body alignment, spine and soft tissues and cause physical problems such as postural disorder, cosmetic trunk deformity, decreased flexibility of the spinal column, changes in spinal muscle characteristics, and back pain. The aim of our study is to examine the effects of physical activity counseling on physical activity level and posture, perception of deformity and quality of life in patients with AIS.

AIS is the most common spinal deformity seen by primary care physicians, pediatricians, and spinal surgeons. The primary goal in the conservative treatment of scoliosis in adolescents is to prevent the progression of the curvature and secondary problems associated with spinal deformity and ultimately to eliminate the need for surgery. For this reason, scoliosis-specific corrective exercise therapy given by a physiotherapist is recommended for patients with AIS. However, while this treatment is effective to the gold standard on spine and posture, its effect on physical activity is not known exactly. The aim of this study is to examine the effect of physical activity counseling on physical activity level and posture, perception of deformity and quality of life in individuals with AIS who are given physical activity counseling in addition to scoliosis-specific corrective exercises. Individuals with AIS in both groups, in accordance with the Schroth classification, individually planned exercise program aimed at correcting and stabilizing the spine in three dimensions, in the form of 45-60 minutes sessions, 2 days a week for 8 weeks, a total of 16 sessions. Group 1 will be given physical activity counseling as well as scoliosis-specific corrective exercises. Physical activity counseling will be done face-to-face, and one-on-one interviews will be provided with each participant. Each meeting will last approximately 20-30 minutes and individuals will be encouraged to participate in more physical activity by providing alternative solutions on their physical activity habits, what they like to do or how they can access activities.

Eligibility Criteria:
Inclusion Criteria:

* Being diagnosed with Idiopathic Scoliosis by an orthopedic specialist
* Cobb angle determined on anteroposterior radiograph is 10 - 45 degrees

Exclusion Criteria:

* Having mental problem, rheumatological, neuromuscular, cardiovascular, pulmonary disease
* Any treatment approach for scoliosis in the last six months
* Having any orthopedic problems that may affect their participation in exercise and/or physical activity
* Having a regular exercise habit
Organic Pollutants in Pelvic Endometriosis

The health toxicity of polycyclic aromatic hydrocarbons (PAHs), present in air and food, generated during energy production and waste incineration, is well known. PAHs can activate the aryl hydrocarbon receptor, which may interact with classic estrogen receptors and modify estrogen-dependent inflammation in endometriosis. There is no data on the hypothetical role of PAHs in the etiopathogenesis of endometriosis. The aim was to compare PAHs concentrations in visceral fat in women with endometriosis and idiopathic infertility.

A prospective cohort tertiary-center study includes women undergoing laparoscopy due to pelvic endometriosis (arm 1) or/and idiopathic infertility (arm 2). A sample of 1 ml of the greater omentum is collected intraoperatively for detection of 16 PAHs, i.e. acenaphthene, acenaphthylene, anthracene, fluoranthene, fluorene, naphthalene, phenanthrene, pyrene, benz\[a\]anthracene, benzo\[b\]fluoranthene, benzo\[k\]fluoranthene, benzo\[ghi\]perylene, benzo\[a\]pyrene, chrysene, dibenz\[a,h\]anthracene, and indeno\[1,2,3-cd\]pyrene, by gas chromatography-isotope dilution mass spectrometry method. The concentration of selected PAHs in visceral fat in both populations will be compared. The correlation of concentrations of selected PAHs with the occurrence of infertility, pelvic pain syndrome, intensity of pain, peritoneal adhesions and the degree of endometriosis will be checked.

Eligibility Criteria:
Inclusion Criteria:

i) age 18-45, ii) indications for surgical treatment of endometriosis, iii) indications for invasive diagnostics and surgical treatment of idiopathic infertility.

Exclusion Criteria:

-
Obesity Prevention in African American School Children

Obesity is the second leading preventable cause of disease and death in the United States. Low socioeconomic status (SES) and minorities are disproportionately affected. Obesity prevention among children and adolescents is a public health priority. Schools have been identified as key settings for obesity prevention; however, most health education interventions have had only a moderate effect on body weight. We propose a randomized intervention trial (pilot study) to test the feasibility and effectiveness of a school-based, environmental obesity prevention program in urban low-SES African American students. Schools, students and their families, and local communities will be involved to promote healthy eating and physical activity (HEPA) for prevention of childhood obesity. Six Chicago public schools will be randomly assigned as intervention (4 schools) and controls (2 schools). Focus group studies will assess needs and barriers for promotion of HEPA and guide the intervention. The intervention group will receive a School Environment Enrichment (SEE) program to modify the school physical and social environment, targeting food service, recess, physical education (PE) and school climate, and a Community Support \& Environment Modification (CSEM) program, involving local corner and chain grocery stores to promote healthy eating among students and their families. Family involvement will be included for 5th and 6th graders, who will be followed for two years, to test ways to modify family environment. To assess the intervention effectiveness, multilevel data will be collected from schools (eg, food service, recess and PE), students (eg, body weight, eating and physical activity), parents (eg, family food purchasing practices) and communities (eg, available choices of snack foods in local stores). In addition, process evaluation data will be collected to assess the feasibility and acceptance (participation and satisfaction) of various intervention components by the target audience. The primary outcome variable is change in students' body weight status; secondary outcomes include changes in students' eating behavior and physical activity and changes in target environmental factors. In addition, cost-effectiveness of the intervention will be determined. If the intervention proves effective, a full-scale study will be developed. Findings from this study will provide insights into the prevention of obesity among low-SES and minority students.


Eligibility Criteria:
All 4-6th graders in the selected public schools in Chicago and their parents/guardians
Adaptive Radiotherapy in Head and Neck Tumor Patients

Most newly diagnosed oropharyngeal and hypopharyngeal cancers are treated with radiochemotherapy with curative intent. If the field-set UP margins are broad, the consequence may be that quality of life is impaired. The study group of Nutting et al. (2023) investigated this year whether dysphagia-optimized intensity-modulated radiotherapy can reduce the radiation dose to structures associated with dysphagia and aspiration and improve swallowing function compared to standard IMRT (Nutting C, Finneran L, Roe J, Petkar I, Rooney K, Hall E; DARS Triallist Group. Dysphagia-optimized intensity-modulated radiotherapy versus standard radiotherapy in patients with pharyngeal cancer - Authors' reply. Lancet Oncol. 2023 Oct;24(10):e398. doi: 10.1016/S1470-2045(23)00457-6. PMID: 37797636.) The study group concluded that the results suggest that dysphagia-optimized IMRT improves patient-reported swallowing function compared to standard IMRT. DO-IMRT should be considered the new standard of care for patients receiving radiotherapy for pharyngeal cancer, and ART could further improve outcomes.

Most newly diagnosed oropharyngeal and hypopharyngeal cancers are treated with radiochemotherapy with curative intent. If the field-set UP margins are broad, the consequence may be that quality of life is impaired. The study group of Nutting et al. (2023) investigated this year whether dysphagia-optimized intensity-modulated radiotherapy can reduce the radiation dose to structures associated with dysphagia and aspiration and improve swallowing function compared to standard IMRT (Nutting C, Finneran L, Roe J, Petkar I, Rooney K, Hall E; DARS Triallist Group. Dysphagia-optimized intensity-modulated radiotherapy versus standard radiotherapy in patients with pharyngeal cancer - Authors' reply. Lancet Oncol. 2023 Oct;24(10):e398. doi: 10.1016/S1470-2045(23)00457-6. PMID: 37797636.) The study group concluded that the results suggest that dysphagia-optimized IMRT improves patient-reported swallowing function compared to standard IMRT. DO-IMRT should be considered the new standard of care for patients receiving radiotherapy for pharyngeal cancer, and ART could further improve outcomes.

Thus, in this trial we analyze ART in head and neck cancer in a prospective randomized trial.

Eligibility Criteria:
Inclusion Criteria:

ECOG 0/1 No prior cancer treatment

Exclusion Criteria:

ECOG 2-4 Prior cancer treatment
Partnering With Media and Vaccination Program to Improve Infant and Young Child Feeding

Infant and young child feeding (IYCF) is a key determinant of under-nutrition and overweight in young children. In Mexico, breastfeeding extends well into the second half of infancy, but animal-source foods, cereals, and legumes are not regularly provided to the child by 9 mo. This study evaluates whether knowledge and practices about dietary diversity and food consistency can be improved using a two-component intervention strategy in semi-urban communities in Mexico. The two components will deliver appropriate complementary feeding messages using: (a) nurses during the 1st National Vaccination Week (NVW); and (b) radio messages and interviews. The intervention is evaluated using a cluster randomized design in small semi-urban communities in two states in Mexico with pre- and post-test questionnaires designed to assess changes in feeding behaviors.


Eligibility Criteria:
Inclusion Criteria:

* Mothers with healthy children between 6 and 24 mo

Exclusion Criteria:

* None
Educational Intervention to Increase Select Guideline-recommended Cardioprotective Medications in Patients With Diabetes

This is an educational outreach to patients with type 2 diabetes mellitus (T2DM) and atherosclerotic cardiovascular disease (ASCVD) and their primary care and specialist providers to improve use of guideline-recommended treatments, specifically sodium-glucose cotransporter 2 inhibitor (SGLT2i) and glucagon-like peptide-1 receptor agonist (GLP-1 RA) medications.

Patients with type 2 diabetes mellitus, a history of atherosclerotic cardiovascular disease, without use of select guideline-recommended medications in the previous year will be identified from administrative claims. Primary care providers will be identified, randomly selected and randomized to the intervention arm or control arm. All eligible patients for that provider will be included. The patient's specialist providers (cardiologist and/or endocrinologist, as applicable) will be identified and contacted. The intervention will include a multi-faceted strategy to support providers in the care of their patients by sharing recent guideline-based treatment recommendations and provide patients with information regarding ways to reduce their cardiovascular risk. Outreach will occur for all patients and providers randomized for the intervention - there will be no active enrollment or recruitment.

Eligibility Criteria:
Inclusion Criteria:

Patient

* Patients with T2DM defined as ≥2 outpatient diagnoses of T2DM in any position on separate days; OR ≥1 inpatient diagnosis T2DM in any position; OR ≥1 outpatient diagnosis in any position AND ≥1 medication claim for T2DM
* ≥1 diagnosis code for ASCVD (coronary artery disease diagnoses or procedures, cerebrovascular disease, peripheral artery disease of atherosclerotic origin) on any claim type in any position within the 24-month period prior to identification
* Enrolled in a Humana Medicare Advantage Prescription Drug plan with ≥12 months pre-identification continuous enrollment (no more than a 31 day gap) as of the identification date and currently enrolled as of the identification date
* Age 18-85 years at time of identification
* Patients residing in Kentucky (KY), West Virginia (WV), Pennsylvania (PA), and 6 counties in south New Jersey (NJ) (Burlington, Camden, Cumberland, Gloucester, Mercer, Salem) (United States)

Provider

* Primary care providers of the identified patients

Exclusion Criteria:

Patients

* ≥1 diagnosis or procedure code for end-stage kidney disease, renal transplant, dialysis or kidney failure
* Any hospice or long-term care residence
* ≥1 code for pregnancy/childbirth
* Patients with any use of SGLT2i or GLP-1 RA medications in the pre-identification period
* Patients without an attributed primary care provider
* Patients on do not contact lists
* Patients without valid addresses and telephone numbers
* Patients with ≥1 diagnosis for type 1 diabetes pre-identification

Primary care providers

* Providers on do not contact lists
* Providers without valid fax/mailing address and phone number
* Providers with \<3 or \>50 eligible patients
Face Reconstruction by Allotransplantation of Composite Tissues

To show the feasibility of face transplantation in patients

Most facial defects can be reconstructed with autologous tissues using standard plastic surgical techniques. However, when the circular facial muscles (eg. orbicularis oculi and orbicularis oris) are destroyed by burns, ballistic traumas, tumors, or congenital deformities there are no conventional surgical solutions. The study was designed following the advice of the French National Ethics Advisory Committee for life sciences and health (CCNE). The objectives are to study the feasibility and efficacy of face CTA transplantation, functional results, and influence on quality-of-life, as well as the management of immunosuppression.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 through 65 years
* Signed written informed consent
* patient with a loss of substance of the median third of the face by traumatisms or not carrying the totality of the lips with or without the nasal pyramid.
* validation of the feasibility by a committee of expert in plastic surgery and maxillofacial
* patient with a positive psychologic evaluation
* patient with an anatomical evaluation and assessment pretransplantation positive normal infectious assessment
* Good compliance and capacity of adaptation to the assessment difficulties
* Patient with renal, hepatic, hematologic ,cardiac normal
* Patient profiting from a Social Security cover
* Patient informed patient, having signed a free assent lit with inclusion in the study

Exclusion Criteria:

* patient minor under supervision or deprived of freedom by court order or administrative.
* person remaining in a medical or social establishment
* pregnant. or breast-feeding women
* patient presenting a sever cardiac pathology having a risk of decompensation into pre, per and post operational
* patient presenting a hepatic pathology
* Any cancer that has been in complete remission for \> 5 years malignancies tumoral lesion of the face with 2 years deadline of remission respected renal insufficiency chronic clearance of creatin \< 60l ml/mn
* chronic respiratory insufficiency
* patient presenting an active infection which can be worsened by the immunosuppression
* patient presenting an active infection which can be worsened by the corticoid
* patient with affection being able to compromise post-operative survival
* patient with digestive ulcer
* No known HIV infection
* serology hepatitis B with circulating DNA highlighted quantitatively
* personality emotional unstable
* schizophrenic or not schizophrenic psychosis
Efficacy Study of Nebulized TD-4208 for Chronic Obstructive Pulmonary Disease (COPD)

The purpose of this study is to measure the effectiveness and safety of TD 4208, an investigational drug being developed to treat people with moderate to very severe COPD, compared to placebo, a treatment without activity.


Eligibility Criteria:
Inclusion Criteria:

* Subject is a male or female subject 40 years of age or older

Exclusion Criteria:

* Females who are pregnant, lactating, breast-feeding or planning to become pregnant during the study
Foot Reflexology Therapy and Non-specific Low Back Pain

The aim of this study was to investigate whether the eight therapy session with foot reflexology can reduce pain intensity when applied as an addition to the standards care of low back pain according to the Malaysian low back pain management guidelines.

Low back pain is a common health complaint in most societies. Many treatments for low back pain aim to reduce suffering quicken recovery and minimize recurrence or development of chronic disability. However, low back pain continues as a societal enigma. The aim of this study was to investigate whether the eight therapy session with foot reflexology can reduce pain intensity when applied as an addition to standards care of low back pain according to the Malaysian low back pain management guidelines. Analysis of health-related quality of life will also be carried out.

Eligibility Criteria:
Inclusion Criteria:

* Have been medically diagnosed with a non-specific low back pain.
* Have not received treatment for low back pain within the previous 2 weeks.
* Are at least 18 years old.
* Have both feet and all toes intact and free from wounds.
* Have not undergone any other complementary and alternative therapies during the study.

Exclusion Criteria:

* Have severe coexistent disease and serious pathology or systemic illness.
* Have a specific diagnosed cause of back pain (infection, tumour, osteoporosis, fracture, an inflammatory condition or cauda equine syndrome).
* Have plantar fasciitis.
* Lack the ability to read and write Malaysia language.
* Had plans to move out of the area.
PK Comparison of GL2701 With Finasteride and Tamsulosin in Combination

To compare the relative bioavailability and pharmacokinetic characteristics of a newly single pill combination of finasteride and tamsulosin with a conventional combination of finasteride and tamsulosin in healthy subjects with a single dose, randomized, open-label, 2-sequence -2period crossover study.

This single dose, open label, balanced, randomized, two-treatment, two-period, two-sequence, crossover study was conducted to compare the relative bioavailability and pharmacokinetic characteristics of a newly developed formulation with a conventional formulation in healthy subjects.

For this, a single-center, randomized, single-dose, open-label, 2-period and 2-sequence crossover study with a 14-day washout period was conducted in 26 healthy volunteers. Plasma samples for the analysis of finasteride/tamsulosin were collected up to 48 h after drug administration. Participants received either reference (in combination of of 0.2mg tamsulosin and 5mg finasteride) or test drug formulation (single pill combination of 0.2mg tamsulosin and 5mg finasteride) in the first period and the alternative formulation in the second period. Plasma concentrations of both tamsulosin and finasteride were determined by validated high-performance liquid chromatography coupled to tandem mass spectrometry detection. Pharmacokinetic parameters, including Cmax and AUC, were determined by noncompartmental analysis. Analysis of variance (ANOVA) was carried out using log-transformed Cmax and AUC, and the mean ratios and their 90% confidence intervals (CI) were calculated. According to regulatory requirements set forth by Korea and the US Food and Drug Administration, products meet the criteria for bioequivalence if the 90% CIs of the mean ratios for Cmax and AUC are within the range of 0.80 to 1.25.

Eligibility Criteria:
Inclusion Criteria:

* Males age 20 to 45 years
* Body weight \> 50 kg with 18\~29 kg/m2 body mass index (BMI)
* Signed and dated informed consent form which meets all criteria of current FDA and KFDA regulations

Exclusion Criteria:

* subjects with acute conditions.
* presence of history affecting ADME
* Clinically significant history or current evidence of a hepatic, renal, gastrointestinal, or hematologic abnormality
* Hepatitis B, hepatitis C, or HIV infection revealed on the laboratory findings
* Any other acute or chronic disease
* A history of hypersensitivity to donepezil
* A history of alcohol or drug abuse
* Participation in another clinical trial within 3 months
* smoked \>10 cigarettes daily
* consumption over 5 glasses daily of beverages containing xanthine derivatives
* use of any medication having the potential to affect the study results within 10 days before the start of the study.
* AST or ALT \> 1.25 of upper normal limit
* total bilirubin \> 1.5 of upper normal limit
* systolic blood pressure \< 90 mmHg
* calculated CLcr using Cockroft-Gault equation \< 50 mL/min
Albumin 4 gr/L vs 8 gr/L in the Prevention of Post-Paracentesis Circulatory Dysfunction

The purpose of this study is to determine whether the infusion of albumin 4 gr per liter of ascites removed is as effective as the infusion of albumin 8 gr per liter of ascites removed in the prevention of post-paracentesis circulatory dysfunction

Large-volume paracentesis associated with plasma volume expansion is the first-line treatment of tense ascites in cirrhotic patients. When paracentesis is performed without volume expansion, an high proportion of patients develop a complication named post-paracentesis circulatory dysfunction, which is characterized by a marked activation of the renin-angiotensin-aldosterone system. PPCD has been associated with renal impairment, rapid recurrence of ascites and shorter survival. Infusion of albumin is very effective in the prevention of PPCD, but has sever inherent drawbacks: the theoretical possibility of transmission of infectious diseases and the high costs. Other synthetic plasma volume expanders have been proposed in the last decades, but they are less effective than albumin when large (\> 5 L) volume paracentesis are performed. Albumin is conventionally given in a dosage of 8 gr per liter of ascites removed; however no information has yet been reported on the use of lower dosages of albumin in this context. This would be interesting, because of the obvious advantages in terms of costs reduction.

The aim of the present study is to compare the efficacy of the infusion of albumin 4 gr vs 8 gr per liter of ascites removed in the prevention of PPCD.

Eligibility Criteria:
Inclusion Criteria:

* Cirrhosis and ascites submitted to paracentesis \> 5 liters
* Age: 18-75 years
* Informed written consent

Exclusion Criteria:

* Multinodular HCC (\> 3 nodules)
* Portal vein thrombosis
* Ongoing bacterial infection
* Ongoing or recent (less than one week) bleeding
* Cardio-pulmonary failure
* Hepatorenal syndrome type 1
* Severe coagulopathy: platelets \< 30.000/mm3 and/or PT \< 30%
* Ongoing treatment with vasoactive drugs