cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy of Turoctocog Alfa in Previously Treated Male Children With Haemophilia A

This trial is conducted in Asia, Europe, and North and South America. The aim of this clinical trial is to investigate the safety and efficacy of turoctocog alfa (recombinant factor VIII, rFVIII (N8)) in male previously treated paediatric subjects with haemophilia A.


Eligibility Criteria:
Inclusion Criteria:

* Male patients with severe (baseline FVIII less than or equal to 1%) haemophilia A
* Age below 12 years and weight at least 11 kg

Exclusion Criteria:

* Surgery planned to occur during trial participation (exceptions are port placement, dental extractions, and minor, uncomplicated emergent procedures)
* Congenital or acquired coagulation disorders other than haemophilia A
* Any history of FVIII inhibitors (greater than or equal to 0.6 BU/mL)
Hysteroscopic Evaluation and the Clinical Outcomes of Vaginal Repair of Cesarean Section Scar Defects

Cesarean section scar defects (CSDs) are one of the long-term complications following cesarean section. They can be detected by transvaginal sonography, hysterosalpingography, sonohysterography and magnetic resonance imaging (MRI). Hysteroscopy is frequently used in evaluating endometrial disease. However, the description of CSDs by hysteroscopy is very limited. Only a few papers about hysteroscopy evaluation have been published. This is an exploratory study to compare hysteroscopic findings with the clinical outcomes of vaginal repair of CSDs.

All women with CSD suffered from abnormal uterine bleeding and were evaluated in a standardized way with hysteroscopy before vaginal surgery. Dome-shaped CSDs could be clearly observed in all patients under hysteroscopy. We recorded the pictures of each patient under hysteroscopy and classified them. They all underwent vaginal excision and suture of CSD and will be required to undergo examinations at 3- and 6-months after surgery. Preoperative and postoperative clinical information will be collected. All patients obtain menstrual information and CSD scar size by MRI or transvaginal sonography.

Eligibility Criteria:
Inclusion Criteria:

* The inclusion criteria are non-pregnant patients who had one or more cesarean sections, patients who had intermenstrual spotting after the cesarean section or those in which the TRM was less than 3.0 mm at the preoperative stage, and patients who underwent MRI and TVS to evaluate the size of the defect and the TRM before surgery

Exclusion Criteria:

* Patients who had a history of chronic diseases (such as cerebro-cardiovascular diseases, malignancies and diabetes mellitus), endocrine disorders, menstrual irregularities before cesarean section, coagulation disorders, use of intrauterine devices, sub-mucous myoma, endometrial diseases, endometrial cysts, uterine fibroids, and adenomyosis after cesarean section
Study of of Oxygen Nebulized Inhalation EGCG in Cancer Patients With New Coronary Pneumonia

Epigallocatechin-3-gallate (EGCG) is a major polyphenol of green tea that possesses a wide variety of actions, such as anti-inflammatory, anti-fibrotic, pro-apoptotic, anti-tumorous, and metabolic effects via modulation of a variety of intracellular signaling cascades. In addition, preclinical studies have also emphasized the antiviral activity of epigallocatechin-3-gallate (EGCG), including SARS-CoV-2. In previous studies, we found that EGCG can prevent and cure radiation- induced normal tissue damage in tumor patients. In clinical studies, we found that EGCG can prevent and treat radiation-induced acute radiation esophagitis, acute radiation skin injury, acute radiation oral mucositis with high safety. At the same time, the phase I clinical trial designed by us has confirmed the safety and efficacy of EGCG in the treatment of interstitial pneumonia.

The Phase II study was conducted with a randomized, controlled, placebo dose determined by Phase I. the subjects were divided into two groups (experimental group and placebo group). To observe the effectiveness of EGCG, the researchers will use both clinician assessment and patient self-assessment. Primary endpoint: change in imaging (chest CT) before and after treatment. Secondary evaluation endpoints: 1 Further evaluation of the safety of EGCG. 2 The degree of symptom improvement . 3 Changes in laboratory testing indicators.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed malignant tumors by pathology or cytology
* COVID-19 with a confirmed positive polymerase chain reaction or antigen test result for SARS-CoV-23
* moderate-to-severe COVID-19 pneumonia (defined as any radiographic evidence of pulmonary infiltrates and oxygen saturation \>94% on room air)
* Pulmonary function of the patient can be treated with aerosol inhalation for 7 days

Exclusion Criteria:

* Current or recent progresses rapidly and may develop into a Critical illness with coronavirus in a short period of time
* Caused by other viruses such as cytomegalovirus, as well as pneumocystis pneumonia, pulmonary edema, aspiration pneumonia and acute interstitial pneumonia
* Any condition including medical, emotional, psychiatric, or logistical that, in the opinion of the Investigator would preclude the participant from adhering to the protocol or would increase the risk associated with study participation
* known allergy or hypersensitivity to EGCG
Ghrelin Regulation and Structure: Effect of Thiazolidinedione Therapy on Ghrelin

The purpose of this study is to learn more about how insulin resistance (inability to process glucose correctly resulting in mildly elevated glucose levels) affects the hormone ghrelin.

Insulin resistance suppresses fasting ghrelin levels and impairs postprandial ghrelin suppression. Improved insulin sensitivity with a thiazolidinedione will raise ghrelin levels, enhance meal-related suppression, but not change the ratio of total to active ghrelin or result in an alteration of ghrelin structure.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 80, weight stable for at least 3 months
* At lifetime maximal body weight and impaired glucose tolerance (ICT) by the World Health ORganization criteria:

  * fasting plasma glucose level of 100- 125mg/dL or
  * plasma glucose level between 140 to 149mg/dL following a 75gram oral glucose load

Exclusion Criteria:

* Actively losing weight
* Smokers
* Alcohol consumption \> 2 drinks/day
* Prescription drug use
* Recreational drug use
* Type 2 Diabetes
* Conditions that contraindicate treatment with pioglitazone such as CHF, impaired liver or kidney function or known sensitivity to pioglitazone
Effectiveness of MyCancerGene to Optimize Genetic Testing Outcomes

This protocol aims to evaluate the efficacy of a theoretically and stakeholder informed patient-centered genetic Interactive Health Communication Application to increase patient understanding of, and affective and behavioral responses to genetic testing. The study investigators hypothesize that the intervention will be associated with increases in knowledge, decreases in distress, increases in communication with relatives and health care providers, and increases in performance of risk reducing health behaviors.

As clinical practice increasingly use multi-gene testing, many patients are left with unknowns after genetic testing. Many have results that are unclear and may or may not be associated with any risk for cancer (Variants of Uncertain Significance), or mutations in genes with very limited information about disease risk or the best medical management. Importantly, many of these uncertainties will be clarified over time, but there is a need for effective ways of communicating these updates to patients who had testing months or years ago. In some cases, there may be multiple updates over time. To address this, this study will provide patients access, using an Interactive Health Communication Application, MyCancerGene, to information about their genetic testing, their specific results and the implications, the ability to print reports and other materials for their relatives and other health care providers and to assess if there has been a change in the personal or family history. Additionally, patients can contact their genetic provider through MyCancerGene and the cancer genetics team can send out updates to patients about their individual results or about new information about risk estimates or screening recommendations. The study investigators hypothesize that MyCancerGene will be associated with increases in knowledge, decreases in distress, increases in communication with relatives and health care providers, and increases in cancer screening and risk reducing health behaviors. After 12 months, all patients will have access to MyCancerGene, which will aid in understanding who benefits most and least from this intervention.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* English Speaking
* Male or Female
* Internet and/or mobile access
* Previously received clinical genetic counseling and testing for hereditary cancer syndromes (up to 60 days prior to recruitment)

Exclusion Criteria:

•No internet and/or mobile access
Effect of Weight Loss on Cholesterol Metabolism in Hereditary Hypercholesterolemias and Overweight or Obesity.

Background: Lipid lowering response to weight loss in subjects with genetic hyperlipidemias and overweight or obesity and its effect on cholesterol metabolism has not been studied.

Objective: To explore the effects of weight loss on lipid values and cholesterol metabolism, by measuring circulating non-cholesterol sterols, in overweight or obese subjects with genetic hypercholesterolemias.

Design: The investigators conducted a 6-months weight loss intervention in subjects with the diagnosis of familial hypercholesterolemia (FH) or familial combined hyperlipidemia (FCHL), body mass index \>25 kg/m2, steady weight (±3 kg in the last 3 months) and absence of lipid lowering drugs in the previous 5 weeks. They were advised to follow a hypocaloric diet with a deficit of 600 kcal (30% fat, 15% protein, and 55% carbohydrates) per day as calculated from the person's resting energy expenditure and activity level. Anthropometric data, biochemical analysis including lipids, apolipoproteins and non-cholesterol sterols were evaluated at baseline, 3 months and 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years.
* Diagnosis of Familial Combined Hyperlipidemia\* and Familial Hypercholesterolemia\*\*.
* Body mass index \> 25 kg/m2.
* Steady weight (±3 kg in the last 3 months).
* Absence of lipid lowering drugs including sterols supplements in the previous 5 weeks.

  * Familial Combined Hyperlipidemia diagnosis was based on the presence of primary combined hyperlipidaemia in untreated patients whose serum cholesterol and triglyceride concentrations were above the sex- and age-specific 90th percentiles for the Spanish population, serum total apolipoprotein B concentration ≥ 120 mg/dL and there was at least one first-degree relative with hyperlipidemia (total cholesterol and/or triglycerides \>90th percentile) (Gómez-Gerique JA et al; 1999).

    * Familial Hypercholesterolemia was diagnosed in subjects with off-treatment LDL cholesterol concentrations above the age- and sex-specific 95th percentile of a Spanish reference population, triglyceride below 200 mg/dL and familial vertical transmission with at least one first-degree relative with LDL cholesterol above age- and sex-specific 95th percentiles (Gómez-Gerique JA et al; 1999).

Exclusion Criteria:

* Alcohol consumption \>30 gr/day.
* Uncontrolled type-2 diabetes (HbA1c \>8%).
* Any other disease that could interfere with the ability to comply with the study protocol were excluded
* Personal history of cardiovascular disease, very high risk as defined by the presence of ≥ 2 major risk factors, or total cholesterol ≥ 350 mg/dL since lipid-lowering drug were considered highly recommended.
The Effects of Cognitive Dual-Tasking in Later Stages of Rehabilitation After ACL Reconstruction

Anterior cruciate ligament (ACL) injuries are common in sports and often require a long and challenging rehabilitation process. Athletes who sustain these injuries typically engage in pivoting and cutting sports, where these motor tasks must be performed simultaneously with cognitive tasks such as decision-making and keeping an eye on the opponent. Directing attention to both cognitive and motor tasks leads to cognitive-motor interference, which is associated with movement patterns that increase the risk of ACL (re)injury.

Therefore, it is crucial that before returning to such demanding sports after ACL reconstruction, athletes sufficiently develop and automate safe yet efficient motor skills to free up attentional capacity for decision-making, thereby reducing the risk of suboptimal movement patterns and reinjury.

However, current rehabilitation programs often primarily focus on the motor component in a single-task manner, giving insufficient attention to the cognitive component that is inseparable from sports.

This randomized controlled trial aims to investigate the effects of implementing motor-cognitive dual tasks in the end phase rehabilitation after ACL reconstruction on muscle function, functional outcomes, and patient-reported outcomes.


Eligibility Criteria:
Inclusion Criteria:

* 18-40 years old.
* Having suffered an ACL rupture.
* Undergoing a surgical ACL reconstruction in the AZ Delta hospital in Roeselare (Campus Brugsesteenweg).

Exclusion Criteria:

* Revision ACL reconstruction.
* Other severe injuries to the lower limbs within the past year.
* Muscle or neurological disorders affecting lower limb functioning.
* Fibromyalgia or chronic fatigue syndrome.
Safety and Efficacy Study of Eculizumab in Patients With Mild Allergic Asthma

This study is to designed to test the role of complement in the late asthmatic response to allergen challenge in mild asthma, as an indicator of the possible role of complement in the broader asthmatic population.


Eligibility Criteria:
Inclusion Criteria:

* diagnosed with stable, mild, allergic asthma;
* history of episodic wheeze and shortness of breath;
* sexually active women of childbearing potential must use contraceptive during the entire duration of study;
* willing and able to give informed consent;
* positive methacholine challenge;
* positive skin prick test to common aeroallergens;
* positive allergen-induced early and late phase bronchoconstrictor response
* FEV1 at least 70% of predicted value;
* PC20 at baseline that is within 1 doubling dose of that measured during screening

Exclusion:

* active bacterial infection;
* respiratory tract infection or worsening of asthma within 28 days
* use of inhaled or topical steroids within 28 days or use of systemic corticosteroids within 90 days;
* use of cromoglycate, nedocromil, leukotriene receptor antagonists and inhibitors of 5-lipoxygenase within 14 days;
* use of antihistamines, immunosuppressives, or any medications that interact with eculizumab;
* use of theophylline-containing agents (any type), long-acting beta 2-agonists (salmeterol, formoterol) or long-acting anticholinergics within 14 days;
* use of NSAIDs prior to spirometry;
* use of tobacco products currently or within the previous 12 months; or smoking history \> 10 pack-years;
* lung disease other than mild allergic asthma;
* patients with LAR who have not been vaccinated against Neisseria meningitidis;
* hepatitis B or HIV infection;
* parasitic infection;
* participation in any other investigational drug trial;
* pregnant or breast feeding women, or intending to conceive during the course of trial;
* known hypersensitivity to the treatment drug or any of its excipients;
* history of illicit drug use or alcohol abuse within previous year;
* any clinically significant abnormality on screening lab test results;
* abnormal chest X-ray;
* chronic use of any other medication for treatment of allergic lung disease other than short-acting beta2-agonists or ipratropium bromide;
* any medical condition that might interfere with the subject's participation in the study or confound the assessment of the subject;
* unwilling or inability to comply with the study protocol for any reason.
The Yield of Postnatal Thyroid Function Test in the Well Baby Nursery

Thyroid function test are performed in the well baby nursery to newborn infants of mothers with hypothyroidism, or as part of neonatal jaundice investigation. As thyroid function test are also part of the national screening test program, the investigators raised the option that the above management is unnecessary, and managed a study to investigate it.

Thyroid function test are performed in the well baby nursery to newborn infants of mothers with hypothyroidism, or as part of neonatal jaundice investigation. As thyroid function test are also part of the national screening test program, the investigators raised the option that the above management is unnecessary, and managed a study to investigate it.

The study is retrospective. About 4000 infants are born in the center every year. The investigators wish to examine data for 10 years, i.e. about 40000 files.

The investigators will collect all the national screening test program results and compare them to the thyroid function test performed in that center.

Eligibility Criteria:
Inclusion Criteria:

* Infants born in our medical center
* Term infants
* Admitted to well baby nursery and stayed there until discharge

Exclusion Criteria:

* Preterm infants
* Transferred to neonatal intensive care unit for any reason
Feasibility and Preliminary Effects of the Resilience-based, Energy Management to Enhance Wellbeing in Systemic Sclerosis (RENEW) Intervention

Researchers are testing a web-based peer-led program to help manage energy and symptoms in people who have scleroderma. Resilience-based, Energy Management to Enhance Wellbeing (RENEW) was created by researchers, doctors, and patients with scleroderma. The goal is to help people with scleroderma feel better.


Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of systemic sclerosis including:

  * Diffuse or limited cutaneous
* Have access to a reliable, internet-connected device (e.g. computer, tablet)
* Be able to read, speak, and understand English
* Participants need to report a score of at least 4 on a scale of 0 - 10 of fatigue severity, a cut-off for at least moderate fatigue in other fatiguing conditions.

Exclusion Criteria:

* Complex, unstable health issues that would preclude full participation in the study
* Planning to start new treatment for fatigue, pain, mood during the study period
Tc99m Sestamibi Molecular Breast Imaging

This clinical trial studies technetium Tc-99m sestamibi molecular breast imaging in predicting tumor response in patients with locoregional breast cancer that has spread from where it began in the breast to surrounding normal tissue who are receiving neoadjuvant chemotherapy. Comparing results of diagnostic procedures, such as technetium Tc-99m sestamibi molecular breast imaging, done before, during, and after chemotherapy may help doctors predict a patient's response to treatment and help plan the best treatment.

PRIMARY OBJECTIVE:

I. To evaluate the ability of technetium Tc-99m sestamibi (Tc 99m sestamibi) molecular breast imaging (MBI) to predict early response to neoadjuvant chemotherapy (NAC) and to assess residual disease at the completion of NAC in patients with locoregional invasive breast cancer.

SECONDARY OBJECTIVES:

I. To evaluate and qualitatively characterize Tc 99m sestamibi uptake by tumor on MBI at the baseline, after 2 cycles of NAC and at the completion of NAC.

II. To compare assessment of tumor response to NAC by MBI with digital mammography (DM), and breast ultrasound (US) exams.

III. To compare tumor size and distribution observed from MBI at the completion of NAC with extent of residual disease at surgery by pathological evaluation.

IV. To develop image acquisition and processing algorithm that quantifies the Tc 99m tumor uptake.

EXPLORATORY OBJECTIVE:

I. To determine effect of molecular subtype of cancer (Her2+, ER/PR/Her2- and ER+/Her2-) on diagnostic performance of MBI in predicting treatment response.

OUTLINE:

Patients undergo technetium Tc-99m sestamibi molecular breast imaging over 45 minutes at baseline (before start of NAC), after 2 courses of NAC (6-12 weeks, depending on the regimen), and the completion of NAC but before surgery. Patients also undergo breast ultrasound and mammographic imaging as standard of care at the same time points.

Eligibility Criteria:
Inclusion Criteria:

1. Female of 18 years and older of any race
2. Has biopsy-proven invasive breast cancer (BI-RADS 6) and scheduled for neoadjuvant chemotherapy (NAC).
3. Newly diagnosed biopsy proven locoregional invasive breast cancer at MD Anderson Cancer Center, or referred to MD Anderson for treatment after initial radiologic (mammographic, sonographic, etc.) exams at an outside institution in whom NAC is planned.
4. Patients with stage T1 or greater (T1-T4), nodal involvement (N0 - N3), without metastasis (M0) invasive breast cancer, including patients with inflammatory breast cancer.
5. Patients who agree to sign an informed consent to undergo MBI

Exclusion Criteria:

1. Is under 18 years of age
2. Is pregnant (confirmed by the patient as Imaging Clinic standard of care) or nursing mother
3. Has lesions involving chest wall
4. Has known allergy to Tc99m sestamibi
Glaucoma After Congenital And Infantile Cataract Surgery

Pediatric patients who have undergone surgery for congenital or infantile cataracts have a risk of developing suspected glaucoma and glaucoma, but the current evidence does not address our understanding of the incidence and associated risk factors of suspected glaucoma/glaucoma for application in clinical standard care. Therefore, this study investigated the incidence of and risk factors for suspected glaucoma/glaucoma in patients who have undergone surgery for congenital/infantile cataracts.

A prospective longitudinal cohort study of pediatric patients who underwent surgery for congenital/infantile cataracts between January 2011 and December 2021 was performed.

Eligibility Criteria:
Inclusion Criteria:

* a diagnosis of congenital/infantile cataracts without any surgical intervention;
* age younger than 10 years;
* cataract surgery performed at the Zhongshan Ophthalmic Center after enrollment

Exclusion Criteria:

* a preoperative IOP above 21 mm Hg;
* the presence of any preoperative sign of glaucoma, such as corneal enlargement, corneal clouding, excessive optic nerve cupping, or a family history of glaucoma;
* the presence of ocular trauma or other abnormalities, such as microcornea, microphthalmia, persistent hyperplastic primary vitreous, Peters anomaly, congenital aniridia, Marfan syndrome, lens dislocation, retinitis pigmentosa, high myopia, fundus lesions, rubella, and Lowe syndrome.