cyrilzakka/clinical-trials huggingface dataset:
Evaluation of the RESTART Survival Programme

The RESTART survivorship programme has been implemented in the care pathway for patients with localised breast cancer since 2022. In this project, investigators are going to evaluate the satisfaction of patients taking part in the RESTART programme, as well as measuring changes in quality of life and health literacy after participation in the RESTART programme.

Prospective longitudinal, single-centre, non-randomised study for patients who have completed acute treatment (surgery, radiotherapy, chemotherapy) for localised breast cancer within the last 3 months.

In this project, investigtors are going to evaluate the satisfaction of patients taking part in the RESTART programme, as well as measuring changes in quality of life and health literacy after participation in the RESTART programme.

The primary objective is to assess satisfaction with participation in the Restart programme and its various components.

Evaluation criteria associated with the primary objective:

Measurement of overall satisfaction and of the various components of the RESTART programme (Likert scale and open questions)

- Evaluation criteria associated with the secondary objective:

To measure before starting the RESTART programme and 1 and 12 months after the end of the programme:

* Patients' Quality of Life (QoL) (using the EORTC30 and BR23 questionnaires for breast cancer)
* Health literacy (via the HLQ questionnaire)
* Professional status
* Patients' physical activity level via the Global Physical Activity Questionnaire (GPAQ)
* Psychological distress, anxiety and depressive symptoms via the Generalized Anxiety Disorder - 7 (GAD-7) and Patient Health Questionnaire-9 (PHQ-9) questionnaires
* Fatigue (via the NRS)
* Patient sleep quality using the Pittsburgh Sleep Quality Index (PSQI) To measure the rate of participation in the programme via the proportion of patients who participated in relation to the number of patients operated on for breast cancer located in Bordet during the same period.

Eligibility Criteria:
Inclusion Criteria:

1. Age \>= 18 at the time of signing the ICF
2. Minimum understanding of French
3. Signed study informed consent form obtained prior to any study-related procedure.
4. Participation in the RESTART programme
5. Patient with curative breast cancer (AJCC stage I-II-III)

Exclusion Criteria:

-
A Study to Learn How Different Products of the Study Medicine Called PF-07940367 Are Taken up Into the Blood in Healthy Adults

The purpose of this study is to compare two finished products of PF-07940367 in terms of the uptake into the blood stream.

This study is seeking participants who are:

- Healthy male or female participants aged 18 years or older.

All participants in this study will receive PF-07940367 once by mouth. The participants may receive different tablets by mouth for PF-07940367.

The study will compare experiences of people receiving two different products of PF-07940367. This will help understand how much PF-07940367 is taken up into the blood for each product given.

Participants will take part in the study for about 112 days. During this time, participants will have to stay onsite for 5 days. There will be up to 2 additional onsite study visits and 3 remote (telephone call) study visits.


Eligibility Criteria:
Inclusion Criteria:

* Male and female participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
* BMI of 16-32 kg/m2; and a total body weight \>50 kg (110 lb).
* Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations and other study procedures.
* Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent document (ICD) and in the protocol.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
* Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).
* History of human immunodeficiency virus (HIV) infection, hepatitis A, hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HBsAg), or hepatitis B surface antigen (HCVAb). Hepatitis B vaccination is allowed.
* Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality or other conditions that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
* Use of prescription or nonprescription drug, dietary and herbal supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study intervention.
* Previous administration with an investigational product (drug or vaccine) within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer). Participation in studies of other investigational products (drug or vaccine) at any time during their participation in this study.
* A positive urine drug test.
Dose-escalating Safety and Preliminary Efficacy of DaxibotulinumtoxinA for Injection in Cervical Dystonia

This is an open-label, dose-escalation study to assess the safety and preliminary efficacy of daxibotulinumtoxinA in subjects with isolated cervical dystonia (CD).


Eligibility Criteria:
Inclusion Criteria:

* Meets diagnostic criteria for isolated cervical dystonia
* Has moderate severity with a baseline Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) - Total score of at least 20 and a TWSTRS-Severity subscale score or at least 15
* Has been using stable doses of focal dystonia medications for at least 3 months and willing to continue through end of study

Exclusion Criteria:

* Cervical dystonia attributable to an underlying etiology, such as traumatic torticollis or tardive torticollis; predominant retrocollis or anterocollis cervical dystonia
* Significant dystonia in other body areas, or is currently being treated with botulinum toxin for dystonia in other areas than isolated cervical dystonia
* Neurological abnormalities other than cervical dystonia
* History of severe dysphagia or aspiration, or current clinically significant swallowing disorder
* Previous neck surgery, phenol injection to the neck muscles, myotomy or denervation surgery in the neck/shoulder region, or intrathecal baclofen
* Marked limitation on passive range of motion that suggests contractures or other structural abnormality, e.g. cervical contractures or cervical spinal deformity
* Profound atrophy of cervical musculature
* Any neurological condition that may place the subject at increased risk with exposure to botulinum toxin type A, including peripheral motor neuropathic diseases such as amyotrophic lateral sclerosis and motor neuropathy, and neuromuscular junctional disorders such as Lambert-Eaton syndrome and myasthenia gravis
* Suboptimal efficacy response to any prior botulinum toxin type A product, when a previous treatment produced more optimal therapeutic response, as judged subjectively by the Investigator
* Previous treatment with any botulinum toxin product for any condition within the 6 months prior to Screening and during the study; presence of any blood coagulation disorder; or on anticoagulation treatment with international normalized ratio (INR) \> 3.5
A Clinical Trial to Evaluate the Pharmacokinetics and Safety of Fimasartan and Rosuvastatin in Healthy Male Subjects

The purpose of this study is to evaluate the pharmacokinetics and safety of Fimasartan and rosuvastatin when coadministered or administered alone as a single dose or as multiple doses to healthy male subjects.

This is an open-label, randomized, 6-sequence, 3-period, 3-way crossover study. Within each period, randomized subjects will be 2 dosing regimens with the same drug(fimasartan or rosuvastatin) or study drug combination(fimasartan+rosuvastatin) on day 1 and quaque die(qd) from day 4 to day 10. After day 1 and day 10 dosing will be followed by pharmacokinetic sampling for 48 hours or 72 hours.

Eligibility Criteria:
Inclusion Criteria:

1. Caucasian male 19-55 years of age.
2. Body mass index (BMI) ≥ 18.5 and ≤ 32.0 kg/m2 at screening.
3. Medically healthy with no clinically significant medical history.
4. Understands the study procedures in the Informed consent form (ICF), and be willing and able to comply with the protocol.

Exclusion Criteria:

1. History or presence of clinically significant medical or psychiatric condition or disease.
2. Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV).
3. Seated blood pressure is less than 90/60 mmHg or greater than 140/90 mmHg at screening.
4. Plasma donation within 7 days prior to the first dose of study drug.
5. Participation in another clinical trial within 28 days prior to the first dose of study drug(s).
Assessment of the Efficacy of Vitamin D-fortified Oil in Healthy Adults

The aim of this study is to evaluate the efficacy of daily intake of fortified sunflower oil with vitamin D on serum 25-hydroxyvitamin D level, glycemic and lipidemic status in healthy subjects compared to plain oil.

Sixty apparently healthy subjects will be selected. Participants who are receiving vitamin D, calcium or omega-3 supplements within the last three months will be excluded. Subjects will be assigned randomly to one of the two intervention groups: 1.fortified sunflower oil, 2. plain bread+vitamin D supplements,3. plain bread+placebo. Each participant will consume 50 g of oil every day for 2 months.

At the first and last visits, dietary and laboratory assessments will be performed for all subjects. Primary outcomes are the improvement in vitamin D status and secondary outcome is the improvement of glycemic and lipidemic markers and prevention of problems related to hypovitaminosis D.

Eligibility Criteria:
Inclusion Criteria:

* 20 to 60 years
* healthy subjects
* no receiving vitamin D or omega-3 supplement in past 3 months

Exclusion Criteria:

- receiving vitamin D or omega-3 supplement during the study
Neurologocal Symptoms in CHD

The aim of the study is to determine neurological and cognitive disorders in children with congenital heart disease for early diagnosis and treatment

Congenital heart defects are significant structural abnormalities affecting the heart and major intrathoracic vessels. They are among the most common birth defects, constituting about one-third of all major congenital anomalies. Many of these defects necessitate surgical intervention during early childhood. Advances in surgical techniques have significantly improved survival rates for patients with congenital heart disease (CHD). However, a variety of systemic complications have become more apparent, including issues affecting the cardiac, pulmonary, gastrointestinal, neurological, and nephrological systems (Walaa El Naga et al., 2022).

Neurological complications greatly contribute to morbidity and mortality in pediatric CHD patients, significantly impacting their neurodevelopmental outcomes. Various studies indicate that up to 30% of children with congenital heart disease (CHD) experience neurological complications. Seizures are the most frequently reported neurological complication, accounting for approximately 70% of cases with neurological sequelae (Aly El Kazaz et al., 2022).

Also Neuropsychological studies of children with complex CHD reveal distinct deficits in intelligence, cognitive performance, executive function, language skills, visuospatial abilities, and attention. (Guo et al., 2021). Recognizing the long-term consequences of accumulated brain injury underscores the importance of identifying and minimizing early insults. (Le H.Sterling et al., 2021) The recognized neurodevelopmental challenges faced by children with CHD prompted the American Heart Association to recommend routine neurodevelopmental evaluations for high-risk patients with CHD. According to the American Heart Association, the initial visit, conducted before 12 months of age, should include a neuromotor examination assessing muscle tone, primitive and deep tendon reflexes, sensory status, and gross motor skills. Although many children with CHD now undergo these recommended neurological examinations, the examinations and their outcomes have not been thoroughly described. Additionally, factors predicting abnormal neurological examination results have not been identified. Enhancing our understanding of the findings from these routinely recommended evaluations will improve the detection of abnormalities, thereby optimizing support for children with CHD and their families.(Le Samantha butler et al., 2023).

Eligibility Criteria:
Inclusion Criteria:

- Children from 3 years to 18 years with congenital heart disease

Exclusion Criteria:

* New born infants. Children with normal heart. Children with chromosomal or metabolic disease.
Clinical Assessment of Burns in Norway

Clinical assessment of burn depth and area can be challenging even for experienced surgeons. Still, the assessment is fundamental for the treatment, as it determines the fluid treatment and indication for escharotomy and need for referral to a burn centre.There are few studies comparing the initial evaluation of burn depth and surface with that of a specialist burn centre. The aim of this study was to make such a comparison for a cohort of patients admitted to a specialist burn centre during one year.The cohort was defined as patients transferred to the burn unit at Haukeland university hospital during 2014.


Eligibility Criteria:
Inclusion Criteria:

* Patients transferred to the burn unit at Haukeland university hospital during 2014

Exclusion Criteria:

* Readmissions
* Patients transported to Haukeland directly from the site of the accident
Nebulized Corticosteroid for Post Extubation Stridor in Children

The purpose of this study is to evaluate the efficacy and adverse effect of nebulized corticosteroid to prevent post-extubation stridor in children.

The guideline for prevention and treatment of post-extubation stridor in children is inconclusive include Nebulized epinephrine and intravenous corticosteroid. Nebulized corticosteroid is alternative treatment for viral croup. the rationale of this study to evaluate the efficacy of nebulized fluticasone propionate to prevent pediatric post-extubation stridor

Eligibility Criteria:
Inclusion Criteria:

* Children age between 1 month old - 18 year old who was intubated

Exclusion Criteria:

* Palliative care
* Anatomical abnormalities of airway; subglottic stenosis
* Neuromuscular disease with negative inspiratory force \< - 30 mmHg
* Need positive pressure after extubation
A Retrospective Review of the Seasonality of Pre-Eclampsia

This retrospective review will will attempt to determine whether our data show a significant difference in number of deliveries of women with pre-eclampsia compared to deliveries without pre-eclampsia during certain months of the year.

This study is a retrospective review of obstetrics charts of women who gave birth at OSU Medical Center between January 01, 2005 and December 31, 2007.

Included will be patient charts of women \> 18 years old who were admitted to OSUMC for delivery (both cesarean and vaginal deliveries) between 1/1/05 and 12/31/07, with and without a diagnosis of pre-eclampsia. The data collected will be recorded in a spreadsheet by month/day of delivery, and whether pre-eclampsia was a diagnosis. Also included will be total number of deliveries per month and total number of pre-eclampsia diagnoses per month. The rate of pre-eclampsia will be calculated.

A contingency table with corresponding chi square test will be performed to determine whether there is a significant relationship of the diagnosis of pre-eclampsia with seasonality, defined primarily by month. Certain data occurring during transition periods between seasons may be excluded from analyses.

Eligibility Criteria:
Inclusion Criteria:

* Women who gave birth at OSU Medical Center between January 01, 2005 and December 31, 2007 and were \> 18 years old who were admitted to OSUMC for delivery (both cesarean and vaginal deliveries) between 1/1/05 and 12/31/07, with and without a diagnosis of pre-eclampsia.

Exclusion Criteria:

* Females under age 18
Topical Lidocaine After Major Arthroscopic Knee Surgery

Pain after major arthroscopic surgery is dependent on an optimal multimodal analgesic treatment.

Lidocaine is well-known as analgesic treatment on skin and hypodermic veins. Since 1996 it has been documented that topical lidocaine has an analgesic effect 24 hours after surgical treatment.

The aim is to determine a possible reduction in pain after knee arthroscopy with topical lidocaine.

Eligibility Criteria:
Inclusion Criteria:

* Patients who were planned for reconstruction of anterior crucial ligament, reconstruction of medial patellofemoral ligament and Elmslie-Trillat procedure for patella instability.
* Patients with synovectomies and menisci resection lasting more than 25 minutes.
* Patients \> 18 years
* Acceptance of informed consent

Exclusion Criteria:

* Patients with rheumatoid arthritis
* Patients with a Body Mass index of \> 35
* Patients who can not read and understand Danish
* Fertile women who does not use secure contraception
The Effect of Smartphone and Hand Anthropometry on Pain and Upper Extremity Functions

Mobile phones have different uses in different disciplines, and this encourages long-term use. For optimum comfort use, it is important to ensure users' awareness when purchasing mobile phones that match their hand sizes. The number of studies in the literature on this subject is limited. In this context, the aim of our study is to investigate the relationship between smartphone and hand anthropometry measurements and upper extremity pain and functions.

Phone design features cause different problems on body mechanics and musculoskeletal system. With the use of smartphones, people tend to maintain incorrect postures for long periods of time, which increases tension in the body. This situation causes complaints such as cervical disc herniation, tingling complaints in different body parts, overuse injuries, Upper Crosses syndrome, and carpal tunnel syndrome. On the other hand, the use of smartphones is increasing among students for reasons such as providing students with freedom of time and space, increasing the speed of teaching and learning, supporting one-on-one learning, and increasing the number of ideas produced by encouraging a group discussion environment.

Mobile phones have different uses in different disciplines, and this encourages long-term use. Although many musculoskeletal system structures can be affected by incorrect postures due to the long-term use of smart mobile phones, it is thought that the upper extremity is most affected. Therefore, the aim of our study is to investigate the relationship between smartphone dimensions and hand anthropometric measurements and upper extremity pain and functions in order to raise awareness when purchasing mobile phones that match users' hand sizes for optimum comfort and use.

Eligibility Criteria:
Inclusion Criteria:

* Sending at least 5 e-mails or text messages a day from your mobile phone,
* Using a smartphone for more than 1 hour a day to play games or browse the internet

Exclusion Criteria:

* Having an existing injury in the hand or upper extremity (suffered 6 months ago)
* Having been diagnosed with a degenerative, inflammatory, musculoskeletal, neuromuscular, or congenital disorder of the hand or upper extremity.
PROSA: Prolactin, Sex Hormones, Growth and Metabolic Biomarkers in Children and Adolescents on Antipsychotics

The objectives of this study are:

1. To determine the prevalence and degree of hyperprolactinemia in children and adolescents aged 7-18 years receiving antipsychotic medications
2. To determine the associations between serum-prolactin and sex hormones / metabolic biomarkers/ clinical symptoms in this population. If clinically relevant associations are found: To determine a potentially existing "no harm" serum-prolactin threshold
3. To determine associations between previous cumulative prolactin-exposure and current pubertal development / growth


Eligibility Criteria:
Inclusion Criteria:

* • In daily treatment with antipsychotic medication belonging to Anatomical Therapeutic Chemical (ATC) group N05A (except N05AN lithium) for a minimum duration of 3 months prior to inclusion

Exclusion Criteria:

* Eating Disorder
* Medical treatment to change sex
* Pregnancy or lactation
Metformin for the Treatment of Endometrial Hyperplasia

The purpose of this study is to see if metformin will be effective in making endometrial hyperplasia without atypia better by returning the tissue to a normal state.

This is a multi-institutional pilot clinical trial designed to estimate the response rate and safety of metformin for the treatment of simple and complex endometrial hyperplasia (EH) without atypia. Enrollment of patients will occur at UNC-Chapel Hill and Southern Pines Women's Health Center. Fifteen patients will be enrolled over the course of 1 year. Metformin will be initiated at 850 mg orally once daily, and titrated up to twice daily over a minimum of 1 months time. Treatment will last 12 weeks and then patients will undergo repeat endometrial biopsy to assess for regression or persistence of EH.

Eligibility Criteria:
Inclusion Criteria:

* Be between the ages of 18-75 years old
* Have a confirmed diagnosis of endometrial hyperplasia without atypia based upon endometrial biopsy
* Have no contraindications to short-term metformin therapy
* Have a creatinine clearance of ≥ 90 ml/min, as calculated by the Cockroft-Gault formula
* Have normal serum transaminase values (AST and ALT)
* Need to be able to undergo metformin treatment for a duration of 12 weeks prior to repeat endometrial biopsy

Exclusion Criteria:

* Are currently taking metformin or have taken metformin in the past 6 months or have a history of an allergic reaction or intolerance at any time to metformin
* Have a history of liver or renal dysfunction.
* Have a random glucose of ≤ 65 or ≥ 200
* Have a recent history of alcoholism. Former alcoholics who have abstained from alcohol for 5 years or more may be enrolled in this study.
* Have a history of vitamin B12 deficiency
* Are pregnant
* Are currently taking insulin
* Are taking a drug that may significantly interact or influence the metabolism of metformin
* In the opinion of the investigator, the patient is felt not to be appropriate for the study
A Phase I Study of BR790 in Subjects With Advanced Solid Tumors

The purpose of the study was to evaluate the safety and tolerability of BR790 tablets as an oral monotherapy in subjects with advanced solid tumors, and to determine dose-limiting toxicity (DLT), maximum tolerated dose (MTD) and/or recommended phase II clinical trial dose (RP2D) .The study is divided into two phases: dose escalation phase and dose expansion phase.


Eligibility Criteria:
Inclusion Criteria:

* Sign informed consent voluntarily.
* Age ≥18 and ≤75 years old.
* Subjects with advanced solid tumors diagnosed by histology or cytology，whose desease progressed after standard treatment or have no standard treatment.
* Had at least one measurable lesion.
* ECOG≤1.
* Expected survival period ≥ 3 months.

Exclusion Criteria:

* Any previous treatment with SHP-2 inhibitor.
* Symptomatic brain metastases.
* Subjects with thoracic/ascites fluid that need drainage or intervention.
* Subjects with not enough organ functional reserve at baseline, which met at least one of the following criteria： ANC\<1.5×10\^9/L PLT\<100×10\^9/L Hb\<90g/L TBIL\>1.5×ULN ALT, AST\>2.5×ULN (without liver metastases) or ALT, AST\>5×ULN (with liver metastases), Cr \>1.5×ULN.
* With uncontrolled severe disease.