cyrilzakka/clinical-trials huggingface dataset:
Mood and Nutrition Interventions in Polycystic Ovary Syndrome

The purpose of this study is to help determine the best treatment plan for women with PCOS who are overweight or obese and experiencing significant symptoms of depression and anxiety.

Specifically, the investigators are attempting to see if there is a difference between cognitive behavioral therapy in combination with nutritional counseling in improving mood symptoms, response to stress, and risk factors for heart disease compared to nutrition counseling alone. The investigators hypothesize that combined treatment with Cognitive Behavioral Therapy (CBT) and nutritional counseling will be more beneficial.

This study will assess the impact of treatment of mood and associated anxiety disorders in conjunction with nutritional/exercise counseling in overweight/obese women with PCOS on cardiometabolic risk. The investigators hypothesize that women with PCOS will have greater benefit from dual intervention (psychological and nutritional/exercise counseling) for change in depressive symptoms and cardiometabolic risk reduction compared to nutritional/exercise counseling alone. In addition, the investigators hypothesize that psychological counseling may improve cardiometabolic risk by decreasing stress responses and stress associated markers of inflammation.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Polycystic Ovary Syndrome (PCOS)
* Overweight or obese (BMI 27-50)
* Screen positive for symptoms of depression

Exclusion Criteria:

* Smoking 5 or more cigarettes per day
* Severe depression/anxiety warranting immediate treatment
* Actively participating in a weight loss program
* Taking medications to control cholesterol or diabetes
* On hormonal therapy (must be discontinued to be eligible)
* Pregnancy or planning to become pregnant during the study period
* Inability to commute to Philadelphia for weekly study sessions
Coronavirus Disease 2019 (COVID-19) Pandemic on the Oral Hygiene Status of Children

The purpose of this study is to compare oral hygiene status and dietary habits of 3-5 years old children and their parents with a questionnaire and clinic examination between pre- and post-COVID-19 period.

Study Rationale and Objectives:

The primary motivation behind this study lies in understanding the impact of the COVID-19 pandemic on oral health behaviors, specifically focusing on children at high risk for dental caries.

Objectives include assessing changes in tooth brushing habits and dietary patterns among both children and their parents.

Study Design:

The study employs a prospective observational design. Participants are parents of 155 children aged 3-5 years. Data collection occurs at two time points: before and after the COVID-19 pandemic.

Data Collection Instruments:

A structured questionnaire is administered to parents. It covers:

Children's and parents' dietary habits (frequency of sugary food consumption). Oral hygiene practices (tooth brushing frequency). The index of decayed-missing-filled deciduous teeth (dmft) is used to assess dental caries status in children.

The COVID-19 pandemic had a limited impact on high-caries-risk children's tooth brushing habits.

However, increased sugary food consumption by both children and parents exacerbated caries risk.

Collaborative efforts between healthcare professionals and parents are crucial to mitigate negative oral health effects during such challenging times.

Eligibility Criteria:
Inclusion Criteria:

* 3-5 year old children with high caries risk. To identify high caries-risk children, the criteria used by the the American Academy of Pediatric Dentistry (AAPD) for assessing a child's dental caries risk were applied.

Exclusion Criteria:

* Childrens with systemic health problems and childrens with any space maintainers.
Can Parecoxib Reduce Post-operative Ipsilateral Shoulder Pain?

The purpose of this study is to compare the efficacy of parecoxib with placebo on the incidence and severity of postthoracotomy shoulder pain, the amount of analgesic requirement for relieving severity of postthoracotomy shoulder pain and adverse events associated with treatment.

The incidence of Post-operative Ipsilateral Shoulder Pain (PISP) varies from 21-97% after thoracic surgery, despite receiving effective thoracic epidural analgesia. This pain has been described as constant, aching in quality, unrelated to position change or respiration. Possible causes of shoulder pain includes injury of the phrenic nerve, the lateral decubitus position, transection of major bronchus or preexisting arthritis condition. The possibilities of prevention and management of PISP are taken into consideration. Thoracic epidural block will be performed in all patients before general anesthesia.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiology (ASA) physical status I-III
* Undergoing pulmonary resection by open thoracotomy

Exclusion Criteria:

* Unable to understand numeric rating scale despite preoperative coaching
* Preexisting shoulder pain at the same operative side
* Having contraindication for thoracic epidural analgesia
* History of previous myocardial ischemia or cerebrovascular accident
* Allergic to NSAIDS, sulfonamides or parecoxib
* Hepatic or renal impairment
* History of current gastrointestinal symptoms
* Fluid retention or congestive heart failure
* Pregnancy
Factors Associated With Poor Dengue Outcomes in Malaysia

This study aims to analyse the results of national data collected by the e-Dengue Information System in order to determine the factors associated with disease outcomes in all patients registered from January 2013 to December 2014.

Dengue is the most important arthropod borne viral disease in humans. The World Health Organization has estimated that more than 70% of the global at risk population live in the WHO southeast Asia and Western Pacific region, which account for nearly 75% of global disease burden from dengue. The number of reported cases of dengue in Malaysia has increased fourfold from 44.3 per 100 000 population in 1999 to 181 per 100 000 in 2007. Serologically confirmed cases are approximately half of the number of reported cases. An increase in dengue deaths in the adult populations has been observed since 2002. A study in Vietnam showed that women and children appear to have increased risk of dengue shock syndrome and death. Children aged 6-10 years had highest risk of Dengue Shock Syndrome (DSS). However, mortality was highest in younger children. However, in a study of 560 adult dengue patients in Martinique, Thomas L et al found that severe dengue were mainly in males, elderly, and presented with abdominal pain, cough and diarrhoea. At present, there is no vaccine or cure for dengue. Treatment is mainly supportive and for symptom relief. Various measures have been employed to decrease the incidence of dengue - these have been mainly by public health measures. However, 2014 has seen a dramatic rise in the number of confirmed dengue cases as well as mortality.

This study aims to analyse the results of national data collected by the e-Dengue Information System in order to determine the factors associated with disease outcomes in all patients registered from January 2013 to December 2014.

An epidemiological observational study will be done by utilizing e-dengue data from year 2013 till year 2014. The inclusion criteria is all dengue cases registered in the e-Dengue information system 2013-2014; and there is no exclusion criteria.

The primary outcome measurement is the disease outcome which included recovery, hospitalisation and death.

All data collected will be analyzed by using descriptive analysis, the prevalence/incidence will be estimated; and regression model will be generated.

Eligibility Criteria:
Inclusion Criteria:

* All dengue cases e-Dengue Information System 2013-2014

Exclusion Criteria:

* Nil
Dendritic Cell Based Therapy of Renal Cell Carcinoma

The purpose of this study is to show if vaccination with autologous dendritic cells pulsed with peptides or tumor lysate in combination with adjuvant cytokines can induce a measurable immune response in patients with metastatic renal cell carcinoma, and to evaluate the clinical effect (objective response rate) of the vaccination regime.

Eligible patients receive vaccination with tumor antigen pulsed autologous monocyte-derived mature dendritic cells with a fixed interval. The dendritic cells are generated from leukapheresis products and frozen after antigen loading.

HLA A2 positive patients are treated with PADRE and oncopeptide pulsed DC; survivin and telomerase peptides. HLA A2 negative patients are treated with KLH and tumorlysate pulsed DC; autologous or allogeneic. Each patient is given 6 immunizations with at least 5x106 peptide/lysate pulsed autologous DC. Vaccination 1-4 is given weekly and 4-6 at 2-week intervals. Those patients who exhibit stable disease, partial response or complete response after 6 injections will be given 4 more vaccinations at 2-week interval. The vaccine is applied by intradermal injection near the inguinal region. IL-2 2 MIU s.c. day 2-6 and Thymosin alpha 1 (Zadaxin®, SciClone) 1,6 mg s.c. twice a week are used for adjuvants. Scans and re-staging tests are performed at scheduled intervals throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven progressive metastatic or locally advanced renal cell carcinoma
* No standard treatment indicated
* Age: \> 18
* WHO-Performance Status 0-1
* At least tone measurable tumor lesions according to the RECIST criteria.
* Life expectancy more than 3 months
* Acceptable CBC and blood chemistry results
* Written informed consent

Exclusion Criteria:

* Patients with a history of any other neoplastic disease less than 5 years ago (excepting treated carcinomas in situ of the cervix and basal/squamous cell carcinomas of the skin).
* Patients with metastatic disease in the central nervous system (CNS).
* Patients with other significant illness including severe allergy, asthma, angina pectoris or congestive heart failure.
* Patients with acute or chronic infection including HIV, hepatitis and tuberculosis.
* Patients who are pregnant.
* Patients who have received antineoplastic therapy including chemotherapy or immunotherapy less than 4 weeks before beginning the trial.
* Patients who receive corticosteroids or other immunosuppressive agents.
* Baseline serum LDH greater than 4 times the upper limit of normal.
* Patients with active autoimmune diseases such as lupus erythematosus, rheumatoid arthritis or thyroiditis.
Face Perception and Impact of Surgical Masks in Preterm Infants

The preferences to masked and unmasked faces is relevant for premature newborns, since Covid-19, most of the faces that surround them during their hospitalization are masked. The Premask project is a continuation of the InfantMask and BabyMask studies (concerning infant and newborn), by studying the visual preferences to masked and unmasked faces of premature newborns.


Eligibility Criteria:
Inclusion Criteria:

* All preterm infants born before 32SA arriving at term (at≥37SA) hospitalized in the neonatology department of the pediatric hospital of Grenoble and approaching discharge will be included.

Of the potential participants meeting the inclusion criteria, those with at least 1 of the following exclusion criteria will not be eligible for inclusion in the study.

Exclusion Criteria:

* Parents not fluent in French
* Parents with no social security rights
* Patient with a syndromic disorder
* Abnormal neurological examination Invasive or non-invasive ventilation at the time of testing of babies requiring, at the time of testing at ≥37SA, non-invasive or invasive ventilatory support as well as labeled syndromic or ophthalmologic disease of prematurity (retinopathies).
* Infection requiring isolation
* Ophthalmologic impairment of prematurity (retinopathy)
A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Activity of Intravitreal LKA651 in Patients With Macular Edema

To evaluate the safety and tolerability of LKA651 in patients with macular edema from diabetic macular edema (DME), neovascular age-related macular degeneration (AMD), or retinal vein occlusions (RVO)


Eligibility Criteria:
Inclusion Criteria:

-Patients with macular edema with center involvement in at least one eye, including those with focal or diffuse DME, neovascular AMD, or RVO

The ETDRS letter score in the study eye must be 60 letters or worse (approximate Snellen equivalent of 20/63)

Vital signs as specified within the protocol

Exclusion Criteria:

-Proliferative diabetic retinopathy in the study eye, with the exception of tufts of neovascularization less than one disc area with no vitreous hemorrhage

Patient, with type 1 or type 2 diabetes who have a hemoglobin A1C \> or = 12% at screening

other ocular conditions as specified in the protocol

systemic conditions as specified in the protocol
Gastric Emptying Times of Normal and Obese Children After Preoperative Clear Fluid Drinking: An Ultrasound Study

In the recent literature, pre-operative fasting times for pediatric patients are limited to one hour for clear fluids. Studies related to gastric emptying times mostly searched for normal-weight children. These studies have claimed that 3 mL/kg clear fluid can be allowed up to 1 hour before surgery. There is a lack of interest in the gastric emptying time of obese pediatric patients during the preoperative period. In addition, there is controversy about gastric emptying times of obese healthy children. Some research committed the decrease of gastric emptying because of a high level of sensitivity to cholecystokinin, while others postulated that no change in gastric emptying time of obese children compared to normal weight. The aim of this trial is to compare the gastric volume and gastric emptying time after ingestion of 3 mL/kg clear fluid in obese and non-obese pediatric patients in the pre-operative period.

After receiving informed consent from the children and their families, American Society of Anesthesiologists (ASA) 1-2 pediatric patients between 6-14 years, who will recruit for elective surgery will be included for this study. The children over 95% percentile will be accepted as obese. After, the basal gastric volume will be calculated with the help of Ultrasonography (USG). The children will receive oral 3 mL/kg(max 250 mL) 5% dextrose .USG evaluation will be made every 5 minutes until the gastric volume reaches the basal level. Children reaching basal gastric volume will be accepted as suitable for the surgery. The aim of this study is to compare the gastric volume and gastric emptying time after ingestion of 3 mL/kg clear fluid in obese and non-obese pediatric patients in the pre-operative period.

Eligibility Criteria:
Inclusion Criteria:

* ASA physical state I or II
* Age 6 to 14 years.
* Gender: both sexes.
* Scheduled for non-Gastrointestinal Tract elective day-case surgery under general anesthesia.

Exclusion Criteria:

* Parent/ care giver refusal
* Ages \< 6 or \> 14 years old
* Children with gastro-esophageal reflux disease
* Renal failure
* Diabetes mellitus
* Cerebral palsy patients
* Mental retardation
* Esophageal strictures, achalasia or any intestinal disease that may impair the gastric emptying.
* Gastrointestinal system surgery and neurosurgical patients
* Emergency surgery
* Violation of the prescribed fasting times
* Refusing to drink prescribed clear fluid
Study of AG-120 and AG-881 in Subjects With Low Grade Glioma

Study to evaluate the suppression of 2-HG (2-hydroxyglutarate) in IDH-1 mutant gliomas in resected tumor tissue following pre-surgical treatment with AG-120 or AG-881.

A phase-1, multi-center study in recurrent non-enhancing gliomas with IDH1 R132H mutation for patients who require surgery. The purpose of this study is to evaluate the suppression of 2-HG by comparing the concentration of 2-HG in resected tumors from IDH1 mutant glioma subjects following AG-120 or AG-881 treatment with the 2-HG concentration in untreated, control tumors. The safety, tolerability, PK/PD, and anti tumor activity data from the study in subjects with recurrent non-enhancing Grade 2/3 LGG with an IDH1 R132H mutation for whom surgical resection is indicated will identify the recommended dose of AG-120 and AG-881 for future studies in glioma.

Eligibility Criteria:
Inclusion Criteria:

1. Be ≥18 years of age.
2. Have histologically or cytologically confirmed recurrent Grade 2 or 3 LGG (oligodendroglioma or astrocytoma according to World Health Organization 2016 classification).
3. Have documented IDH1 R132H gene mutation by local testing and known 1p19q or ATRX mutation status by local testing.
4. Have central confirmation of primarily non-enhancing disease by MRI with less than or equal to 5 mm slice thickness and up to 1 mm interslice gap on either 2D T2 weighted image, 3D T2 weighted image, or FLAIR, with at least 1 non-enhancing tumor measuring 1×1×1 cm.
5. Be candidates for clinical resection but for whom surgery is not urgently indicated (eg, for whom surgery within the next 2-4 months is appropriate).
6. Have KPS of ≥60%
7. Have expected survival of ≥12 months.

Exclusion Criteria:

1. Have received prior systemic anti-cancer therapy within 1 month of the first dose of AG-120 or AG-881 or have received an investigational agent \<14 days prior to their first dose of AG-120 or AG-881. In addition, the first dose of AG-120 or AG-881 should not occur before a period of ≥5 half-lives of the investigational agent has elapsed.
2. Have had radiation within 6 months of the first dose of AG-120 or AG-881. (Note: Prior biopsy or surgery is allowed.)
3. Have received any prior treatment with an IDH inhibitor.
4. Have received any prior treatment with bevacizumab (Avastin).
Safety and Immunogenicity of Different Meningitis Vaccine Formulations in Adolescents and Young Adults

This study will evaluate the safety and immunogenicity of combination vaccines as compared to the reference vaccines


Eligibility Criteria:
Inclusion Criteria:

* Healthy adolescents aged 10 through 25 years of age inclusive at the time of enrollment.

Exclusion Criteria:

* History of any meningococcal vaccine administration;
* Current or previous, confirmed or suspected disease caused by N. meningitidis;
* Pregnant or nursing (breastfeeding) mothers;
* Females of childbearing age who have not used or do not plan to use acceptable birth control measures, for the duration of the study;
* Any serious, chronic, or progressive disease;
* Known or suspected impairment/alteration of the immune system;
* Receipt of blood, blood products and/or plasma derivatives, or a parenteral immunoglobulin preparation within the previous 90 days;
* History of severe allergic reactions after previous vaccinations or hypersensitivity to any vaccine component.
Novel Multimodality Imaging for Navigation in Skull Base Surgery

Successful neurosurgery to remove tumours around the base of the skull, such as a vestibular schwannoma, depends on achieving maximal tumour removal whilst preserving crucial neurological functions such as facial movement, and maintaining quality of life.

Current techniques to direct surgery are based on the surgeon's expertise and knowledge of the relevant anatomy, supplemented by the use of electrical recording and stimulation of the facial nerve. However, it is often very difficult to visualise the nerve during surgery and facial nerve paralysis remains a potentially devastating complication of surgery.

Advanced imaging methods may be used to visualise important neural connections in the brain and computer-assisted processing can generate tumour maps from MRI and ultrasound scans. This study aims to utilise these technologies to develop a 3D navigation system for skull base surgery.

This study aims to develop a system that will combine MRI and intraoperative ultrasound imaging to enhance the surgeon's view of the tumour, facial nerve and other surrounding critical structures during surgery. This information will be made available in the navigation system in the operating room so that operations are more precise resulting in better tumour removal rates and fewer complications.

The system will be assessed during the treatment of 20 patients with vestibular schwannoma at the National Hospital for Neurology and Neurosurgery. This feasibility study will validate the different parts of the new system and help us design a future research study to determine its effectiveness in improving patient care.

This project will result in safer and more effective neurosurgery, with potential consequent financial savings for the NHS and the UK, in addition to marked improvements in the quality of life of patients and reduced dependency upon others.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients aged 18-85 years
* Patients with a vestibular schwannoma who are scheduled for surgery
* Patients willing and able to provide written informed consent

Exclusion Criteria:

* Patients aged under 18 years of age or older than 85 years
* Previous, treated posterior fossa brain tumour(s)
* Previous ear or facial surgery on ipsilateral side of tumour
* Neurofibromatosis Type II
* Participation in other clinical trials
* Any contraindication for MR imaging
* Any contraindication for MR contrast agent administration
* Any contraindication for CT imaging
* Pregnancy or breast feeding
Effect of Acetyl-L-carnitine on Chronic Pancreatitis

An open label pilot study will determine the effect of the amino acid nutritional supplement acetyl-L-carnitine (ALC) on pain, quality of life, well-being, and serum pro-inflammatory mediator and oxidative stress levels in volunteers with chronic pancreatitis. The ALC is given to all participants for 3 months, and assessments will occur at intake and after 3 months.

This is an open label pilot study to determine the effect of the amino acid nutritional supplement acetyl-L-carnitine (ALC) on chronic pancreatitis. ALC is an acetylated form of naturally occurring amino acid L-carnitine ((R)-3-Acetyloxy-4-trimethylammonio-butanoate) found in red meat and is readily commercially available. Supplementation with ALC may decrease pain and improve overall health based on our preclinical treatment studies in rats with high fat and alcohol induced pancreatitis. In rats, ALC reduces pain measures, improves glucose tolerance, decreases lipid peroxidation, and Ki67 cellular injury biomarker, and improves pancreatic histopathology. The measurable outcomes of this clinical study are patients' questionnaire scores for:

pain, quality of life, well-being, and serum pro-inflammatory mediator and oxidative stress levels in volunteers with chronic pancreatitis. The questionnaires are given at intake and at experiment end (3 months). Participants will receive ALC for 3 months. These findings will indirectly determine the effect of ALC on the function and inflammatory state of the pancreas. Currently, there is no specific therapy for chronic pancreatitis, and its pathophysiology is still poorly understood. It is known that chronic pancreatitis is caused by ongoing inflammation in the pancreas, yet, no pharmacological intervention exists that optimally addresses this. The broad actions of ALC as an antioxidant and anti-inflammatory agent as well as its ability to reduce side-effects of alcohol cessation make it a perfect compound to pursue for the treatment of pancreatitis.

Eligibility Criteria:
Inclusion Criteria:

* Only patients with chronic pancreatitis are included.

Exclusion Criteria:

* Patients with pancreatic pseudocysts, abscesses, pseudoaneurysms, pancreatitic fistulas, pancreatic adenocarcinoma,
* Females that are pregnant or lactating
* Children are excluded.
* Patients suffering from seizure or thyroid disorders are also excluded due to possible exaggeration of their symptoms from taking ALC according to manufacturer.