cyrilzakka/clinical-trials huggingface dataset:
Health of IVF Versus IVM Children (FM-BABIES)

The investigators conduct a follow up of our randomized controlled trial (RCT) to investigate the development of children born from In-vitro fertilization (IVF) and In-vitro maturation (IVM), in order to give strong evidence about the safety of IVM in women with high antral follicle count or especially polycystic ovary syndrome (PCOS).

Since the birth of the first baby born from in-vitro maturation (IVM) in 1991, this technique has been considered an alternative solution for treating infertility beside conventional controlled ovarian stimulation for in-vitro fertilization (IVF). Since then, there are already more than 5000 children born from IVM, and that number is on the trend of increasing.

Regarding technique, immature oocytes (germinal vesicle - GV) were aspirated from secondary follicles sized from 2-10mm, under follicle-stimulating hormone (FSH) priming or no ovarian stimulation at all. Afterward, the maturation process was undertaken in an artificial medium, out of a living body. This technique, by reducing the usage of external hormones, is highly effective in minimizing the risk of ovarian hyperstimulation syndrome (OHSS) in women with high antral follicle count, especially polycystic ovarian syndrome, with a rate of OHSS recorded as low as 0 percent. Alongside that, the pregnancy rate, as well as the live birth rate of IVM, when proceeded well, is not lower than conventional IVF. Until now, there is only one randomized controlled trial comparing these two techniques directly.

Due to differences in the process of culturing between IVM and IVF, primarily the maturation is undertaken in an artificial medium, the health of children born from IVM received many interests. Numerous studies have been conducted to compare the development of children born from IVM and IVF. Neonatal outcomes of children born from IVM and IVF are considerably comparable. And the development of children born from these two techniques is not significantly different. All the information, as mentioned above, was not from randomized controlled trials but retrospective or prospective cohort studies. Thus, we conduct a follow up of our RCT to investigate the development of children born from IVM and IVM, to give strong evidence about the safety of IVM in women with high antral follicle count or especially PCOS.

Eligibility Criteria:
Inclusion Criteria:

* All live babies born following the In-vitro Maturation and In-vitro fertilization from our FM study.
* Parents agree to participate in the study.

Exclusion Criteria:

* Babies died under or at 24 months
Foot and Hip Abductor Strengthening in Patients With Knee Osteoarthritis.

The study will be Randomized controlled trail, Subject diagnosed with knee osteoarthritis meeting predetermined inclusion and exclusion criteria will be divided into two groups.

Pre assessment will be done using pain, ROM, function, foot arches and knee alignment as subjective measurement through KOOS questionnaire, goniometer, 2D frontal plane projection, Berkemann foot prints using ink and paper ,30s chair stand test, nine step stair climb,40m fast paced walk test,Global rating of change score respectively . One group will be treated with hip abductor strengthening exercise along with conventional exercises and second group will be treated with intrinsic foot muscle strengthening exercise along with conventional exercises. Post treatment values recorded after the session.After data collection from defined study setting,data will be entered and analyzed at Riphah International University,Lahore

Knee osteoarthritis (OA) is a leading cause of joint pain1 and disability2 in middle- and older-aged individuals, and is one of the most commonly managed conditions in primary care3. Recent incidence rates suggest around 6% of people aged over 45 years develop knee symptoms. Knee OA symptoms and radiographic change that worsen over time can lead to costly surgical intervention.

Compressive forces on the knee caused by knee adduction moment on the medial compartment of the joint are associated with the severity of the disease and intensity of pain. In addition, decreased strength of the quadriceps is one of the contributing factors for the onset of the disease.

short foot exercises (SFE) have shown to be effective using the IFM and excluding the EFM found that SFE contracted the intrinsic muscles of the foot to increase the inner arch of the foot, thereby shortening the longitudinal arch.Pronated foot is deeply related to the medial longitudinal arch (MLA) where the presence of a pronated foot consequently leads to a decrease in the MLA.

Eligibility Criteria:
Inclusion criteria:

* pain at medial side of the knee.
* patient can walk without walking aids.

Exclusion criteria:

* patient with previous hip, knee and ankle surgery.
* patient who received intraarticular injection.
* patient with neurologic and muscle problem.
Effects of Marijuana Used on Lung Function in Persons With Chronic Obstructive Pulmonary Disease (COPD)

The main hypothesis is that persons that smoke or smoked tobacco and marihuana have worsen lung function as compared with persons that only smoke or smoked tobacco.

We will follow persons with already diagnosed COPD (chronic bronchitis and/or emphysema). Obtain their smoking history: tobacco and marihuana and review their pulmonary function study results. Then we are planning to compare both groups.

Eligibility Criteria:
Inclusion Criteria:

* COPD patients former or current tobacco smokers
* COPD patients former or current tobacco and marihuana smokers

Exclusion Criteria:

* History of COPD without pulmonary function testing
* Refusal to provide smoking or marihuana used history
Drug-drug Interaction Study Between UIC201601 and UIC201602

An open-label, multiple-dosing, two-arms, one-sequence study to evaluate the safety and pharmacokinetics after co-administration of UIC201601 and UIC201602 in healthy male volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Subjects whose body weight over 55 kg and ranged ± 20% of calculated Ideal Body Weight;
* Subjects without congenital disease, chronic disease, symptom or any clinical significance of a physical examination and questionnaires;
* Subjects judged as healthy by laboratory tests including blood haematology, biochemistry, urinalysis and serologic tests;
* Subjects able to read and understand a written informed consent, and willing to participate in the study.

Exclusion Criteria:

* Subjects with clinically significant symptoms or medical histories on liver, kidney, neuronal system, respiratory system, haematology, oncology, mental illness and particularly cardiovascular system (hypertension, angina, heart failure, myocardial infarction, etc.) or endocrine system (diabetes, hyperlipidemia, etc);
* Subjects with chronic disease which might affect drug absorption, distribution, metabolism and elimination;
* Subjects with a medical history of clinically significant hypersensitivity or hypersensitivity to the drug-containing atorvastatin or HMG-CoA reductase inhibitor;
* Subjects with a medical history of clinically significant hypersensitivity or hypersensitivity to omega-3 or fish;
* Subject with generic metabolic problems such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption;
* etc.
Advance Care Planning (ACP) in Elderly Cardiac Surgery Patients

This is a prospective epidemiological pilot study to evaluate the feasibility of recruiting and retaining patients in a large multicenter study that will audit Advanced Care Planning (ACP) practices and satisfaction with End Of Life (EOL) communication and decision-making in patients undergoing cardiac surgery using the current validated questionnaires and methodology.

Study Procedures:

Once patients have signed an informed consent they will be asked to complete the ACP evaluation questionnaire. Their level of frailty will be assessed with the 5-meter walk test. Two weeks after discharge (+ or - 7 days) they will be contacted by phone in order to complete 3 sections of the CANHELP questionnaire.

Study Tools

Patient questionnaires:

1. ACP Evaluation questionnaire: 5 questions about advance care planning on admission to hospital from CANHELP study (time predicted 10 minutes)
2. CANHELP questionnaire (sections relationship with doctors, communication and decision making) 2 weeks after discharge (time predicted 25 minutes)

Patient test:

1. 5-minute gait speed

   Patient Assessment Data
2. Standard Demographics
3. Anthropometric data
4. Cardiac variables
5. Comorbidities
6. Lab Values
7. Frailty (assessed using 5-meter gait speed)

Post-surgical outcome data (will be sought in the chart after 30 days post-surgery)

1. Outcome
2. Complications

Eligibility Criteria:
Inclusion Criteria:

* Age and over 70 years
* Admitted for cardiac surgery;
* Able to speak English or French;

Exclusion Criteria:

* Age under 70 years;
* Unable to participate in the follow-up telephone survey;
* Unable to speak English or French.
Association of Anemia With Hospital Costs in Elective Colorectal Surgery

The objective is to measure the adjusted association between preoperative anemia and total hospital costs. We hypothesize that patients with anemia before surgery will have higher hospitalization costs than people without anemia.

This study will examine the association between preoperative anemia (hematocrit less than 0.39; low blood counts) and hospital total costs from elective colorectal surgery. Total costs will be defined as the combination of direct and indirect costs ascertained using standardized patient-level costing algorithms (i.e. the standard way that hospital measure their costs). Adjustment will be made for factors that are likely to influence both the presence of anemia and costs of care.

Eligibility Criteria:
Inclusion Criteria:

* Elective hospital admission
* having colorectal surgery

Exclusion Criteria:

* not enrolled in national surgical quality improvement program data collection
Reversibility of Methacholine Induced Bronchoconstriction

The study will compare salbutamol reversibility of methacholine induced bronchoconstriction between a pressurized metered dose inhaler with a spacer versus nebulizer administration using a vibrating mesh nebulizer.


Eligibility Criteria:
Inclusion Criteria:

* age (years) at least 18, male or female
* no confounding health issue (i.e. no health conditions, other than asthma, that would put the participant at risk or affect data integrity)
* baseline FEV1 ≥ 65% predicted (per Quanjer GLI 2012)
* methacholine PD20 ≤ 800mcg

Exclusion Criteria:

* respiratory infection within 4 weeks of Visit 1
* exposure to triggers of respiratory symptoms within 4 weeks of Visit 1
* currently pregnant or breastfeeding
* current smoker (cigarettes, vaping)
Effect of Pharmaceutical Care in Patients With Bipolar I Disorder (BD I)

This project aims, through pharmaceutical care in patients with Bipolar I Disorder, improve compliance and adherence rate, associated with greater effectiveness and safety of drug therapy to help achieve therapeutic goals, and finally to improving the quality of life of patients.

The objective of the present study was to assess the effectiveness of the Dader Method for pharmaceutical care in the reduction of the use of health care services and the increase in the effectiveness and safety of treatment in patients with Bipolar I Disorder who are discharged or referred for outpatient clinic St John of God-La Ceja. Primary objective: To assess the effectiveness of the Dader method for pharmaceutical care on achieving in reducing the number of hospital readmissions, in the increase of the effectiveness and safety of treatment in patients discharged from the Clinic of Saint John of God -La Ceja - Antioquia with bipolar disorder.

A randomized controlled trial. 200 patients will be randomized to group of control or intervention. Post-randomisation, patients will be required to attend the clinic routinely every 3 months during one year. Every 3 months will be evaluated on the criteria of effectiveness and safety of the treatment. Intervention's group will be following through pharmaceutical care. In the development of the study will be a record of the use of health care services (rehospitalizations, care emergency and outpatient, additional to those scheduled).

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with Bipolar I Disorder
* Have been discharged from the Clinic of Saint John of God -La Ceja-
* Have been resulting from external consultation (outpatient) of the Clinic of Saint John of God -La Ceja-
* Male and female patients aged between 18 and 65 years
* Living in Medellin or any of the following eastern municipalities in the department of Antioquia.

Exclusion Criteria:

* Patients with first episode of manic type, schizoaffective disorder, bipolar disorder II, cyclothymia and other bipolar spectrum disorders, personality disorders that seem bipolar disorder, sociopathic disorder.
* Epilepsy
* Patients unable to comply with the protocol requirements, including severe alcohol and drug use.
* Patients with diagnostic uncertainty.
* Pregnancy or breastfeeding
* Infection with the human immunodeficiency virus (HIV).
* Chronic decompensate disease (no significant diseases): blood pressure values above 180/110 mmHg, total cholesterol above 300 mg / dL, low density cholesterol greater than 160 mmHg, hemoglobin A1c greater than 9%, lower oxygen saturation 90%.
* Mental retardation, presence of any cognitive impairment that prevents understands and signs informed consent.
* Refusal to sign informed consent (Consent must be obtained before any study-related procedures are conducted).
* Illiteracy.
* Patients in electroconvulsive therapy.
An Evaluation of a Novel Food Product in Adults Residing in an Area Endemic for Helminths

The prevalence of intestinal helminths is worldwide. This study will evaluate the tolerability of a novel food product consumed by adults residing in an area endemic for helminths.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Male or Female adults, age 18-45 years old inclusive on date of screening
* Showing presence of no or mild-moderate helminths

Exclusion Criteria:

* Presence of heavy helminth load
* Pregnant or lactating
* Hepatosplenomegaly or clinically significant abnormal hemoglobin, LAT or creatinine
Endo-Vac-Therapy for Post-Sleeve Gastrectomy Leaks

Endoscopic negative pressure therapy (ENPT) is a safe technique, showing promising results in the treatment of leakages of the upper and lower gastrointestinal tract. The purpose of this study is to determine the safety and efficacy of ENPT in the management of proximal staple line leak after sleeve gastrectomy.

Clinical data of 40 cases of post-SG proximal staple line leak treated with ENPT are analysed. Success is defined as resolution of the fistula with no further need for intervention (surgical or endoscopic).

Eligibility Criteria:
Inclusion Criteria:

* Staple line leak detected by endoscopy and/or CT within 30 days after surgery.
* Age 18 years or older.
* Written informed consent.

Exclusion Criteria:

* Declined informed consent.
* Leaks detected later than 30 days after surgery.
Diagnostic Accuracy of EBV C Promoter Methylation Kit in Nasopharyngeal Carcinoma

This clinical study aims to evaluate the diagnostic performance of a new Epstein-Barr virus (EBV) C promoter methylation detection kit. All participants will undergo a series of diagnostic tests including VCA-IgA, EBNA1-IgA, and EBV-DNA assays. Additionally, nasopharyngeal swabs will be analyzed for EBV C promoter methylation. Confirmatory biopsy will be performed on all patients to establish a definitive diagnosis. This comprehensive approach seeks to assess the effectiveness of the methylation detection kit in a clinical setting.


Eligibility Criteria:
Inclusion Criteria:

Participants who meet the following Article 1 and also meet one of Articles 2 to 6 can be enrolled:

* Understand, sign, and date the informed consent document to participate in the study
* Display one or more symptoms or signs indicative of nasopharyngeal carcinoma
* Test positive for EBV antibodies or EBV DNA
* Be diagnosed with other head and neck carcinomas
* Be diagnosed with malignancies associated with EBV infection
* Require differential diagnosis from nasopharyngeal carcinoma during endoscopic or other imaging examinations
* Fulfill any additional conditions deemed appropriate by the investigator for inclusion in this study

Exclusion Criteria:

* Have been diagnosed with nasopharyngeal carcinoma and have undergone treatment
* Experience relapse or metastasis of nasopharyngeal carcinoma following treatment
* Have unsuccessful nasopharyngeal swab collections
* Present any other conditions considered by the investigator as unsuitable for participation in this trial
Course and Complications of Invasive Out-of-hospital Ventilation

The purpose of the study is to determine the frequency and management of respiratory incidence in patients with invasive out-of-hospital ventilation, either living at home for elderly people allay to a weaning centre or at home. Further, the mortality and the frequency of hospital admission will be analyzed.

Background: There has been arise in a number of patients requiring long term ventilation both in the in-hospital as well as the out-of-hospital setting. Despite this, little is known about the subsequent political course of this patients following hospital discharge.

Interventions: This is an observational prospective study over a period of one year in a sample of 50 to 70 invasively ventilated patients living either in a nursing home specialized in the care of ventilated patients or at home. Protocol had been developed containing 20 suspected emergency incidences in respiratory care. The nursing staffs are instructed about the study and how to complete the protocol. The protocol was placed at each patient and every time an emergency occurred, the nursing staff registered the incidence. If an emergency fulfils more than one criterion in the protocol, every applicable criterion was marked. The data will be analyzed using non-parametric descriptive statistics.

Eligibility Criteria:
Inclusion Criteria:

* Age \>=18 years
* existing out-of-hospital ventilation \>6h in 24h

Exclusion Criteria:

* Age \<18 years
* absence of declaration of consent
Nutritional Optimization and Bone Health Management for Older Adults Undergoing Hip Fracture Surgery

The overall objective of this pilot study is to test a comprehensive nutritional intervention in elderly patients diagnosed with hip fracture, which the study team believe will reduce functional decline, morbidity and mortality.

This collaborative pilot study is led by a PI who is a board-certified orthopaedic surgeon with extensive experience in the care of older adults with hip fractures. In addition, the multidisciplinary study team includes a research health scientist with vast experience in nutrition, preventive health, and gerontology. The study team will also be supported by a physical therapist and researcher in the field of rehabilitation of older adults with musculoskeletal disorders. Furthermore, an occupational therapist with expertise in rehabilitation science, conduct of pilot studies, and analysis of interview data will play an important role in this study. Moreover, the statistical analyses will be performed by an expert statistical consultant from our institution, who will be reimbursed on a fee for service basis.

Eligibility Criteria:
Inclusion Criteria:

1. Provision of signed and dated informed consent form
2. Male or female, aged 65-89 years
3. Closed fracture of the proximal femur including the anatomic areas of femoral neck, intertrochanteric and subtrochanteric region
4. Patient indicated for surgical treatment (surgical fixation or arthroplasty) as per orthopaedic surgeon
5. Ability to take oral medication and be willing to adhere to the study drug regimen and to the nutritional guidance provided by nutritional experts.

Exclusion Criteria:

1. Patients with open fractures
2. Surgical treatment other than surgical fixation or arthroplasty, such as proximal femur resection
3. Known allergic reactions to components of the study drugs or who do not tolerate oral nutritional supplementation (e.g. total parenteral nutrition or food allergies)
4. Decisional impairment
5. Prisoners
Characterization and Support of Neurodevelopmental Disorders Associated with Congenital Cardiac MalfoRmations - Neonatal

Congenital heart defects (CHD), as the leading cause of birth defects, affect 12 million people globally and approximately 41,000 newborns each year in Europe. CHD presents a significant public health concern due to its association with high morbidity and mortality rates across the lifespan. Over 50% of infants born with critical CHD will develop neurodevelopmental disorders (NDD), requiring specialized care and impacting their quality of life. NDDs, involving early and persistent disruptions in cognitive, emotional, and behavioral development due to abnormal brain development, are highly variable. They may impact language, learning, motor skills, intellectual efficiency, social cognition, attention, memory, and executive functions, often accompanied by psychosocial difficulties. These hidden disabilities constitute the primary long-term sequelae of CHD, surpassing even cardiovascular complications in impact, and affect children who often undergo multiple cardiac surgeries during early childhood. NDDs are associated not only with complex CHDs but also with simpler CHDs that are repaired in early childhood and considered 'cured.'

The origin of CHD-associated NDDs remains largely unknown. While few genetic or environmental causes have been identified, recent research suggests a possible common origin linking heart malformations and neurodevelopmental abnormalities. The CATAMARAN neonatal cohort project aims to detect developmental delays associated with CHD as early as six months of age and to identify both individual susceptibility factors and acquired vulnerabilities contributing to the development of NDDs in infants with CHD.


Eligibility Criteria:
The inclusion criteria are as follows:

* Fetus with a congenital heart defect (CHD) detected prenatally (prenatal diagnosis of the heart defect)
* Fetus with a critical CHD defined as requiring cardiac surgery during the first three months of the infant's life
* Parents affiliated with or beneficiaries of a social security or equivalent system
* Parents' good understanding of the French language
* Voluntary, informed, and written consent from both parents for themselves and the unborn child

Criteria for parents\*:

- Biological parents \*The inclusion of the father in the project does not limit the participation of the child (patient) in the study.

\*The father will be encouraged to participate in the project by providing a blood sample to create a trio (mother/father/infant) for future genetic analyses.

However, if the father is unavailable or does not consent to the collection and storage of samples for analysis (as part of the CATAMARAN study or future research projects related to biobanking), the child can still be included in the study.

Exclusion Criteria:

* Medical termination of pregnancy considered
* Genetic anomaly or malformative syndrome identified prior to inclusion