cyrilzakka/clinical-trials huggingface dataset:
An Ophthalmic Safety Study in Patients With Breast Cancer

To assess ophthalmic health in parallel cohorts of patients with breast cancer

This is a multicentre study assessing the ophthalmic safety in patients who are participating in a qualifying study. The study will include two cohorts of at least 60 individuals each.

To be able to account for events associated with aging, worsening of pre-existing conditions, etc., ophthalmic study assessments will be performed in parallel in two cohorts at the same timepoints. The duration of the study assessment period will be approximately 12 months. Longer duration of the study would result in additional patient burden.

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent in the qualifying study.
2. Signed informed consent in the ophthalmic study prior to any ophthalmic study specific assessments and procedures.
3. Completed the baseline ophthalmic examination for this study before the first dose in the qualifying study.
4. Meets all the eligibility criteria in the qualifying study

Exclusion Criteria:

1. Patients not randomized and not receiving study assigned treatment in a qualifying study.
2. Patients with contraindications to any ophthalmic procedure required by the study or sensitivity/allergy to pupil dilating agents.
3. Judgement by the investigator that the patient should not participate in the ophthalmic study if the patient is unlikely to comply with study procedures, restrictions, and requirements
Using 16S rRNA Gene Sequencing Analysis Intestinal Microbiota in Constipation Patients

Constipation is a frequent, chronic gastroenterological problem that has many varied symptoms and thus has several clinical definitions. According to the Rome III criteria for chronic constipation, almost 16% of all adults are affected by chronic constipation worldwide, and it is more prevalent and symptomatic in women and elderly people. Slow transit constipation (STC) is the major category and is characterized by a decreased rate of colonic transit.

Recently, many researchers have focused on the relationship between intestinal microbiota and constipation and have demonstrated that intestinal microbiota contribute to the pathophysiology of functional gastrointestinal disorders.

Thus, there is a need for an improved understanding of gut microbiota composition in constipation patients and for the potential role played by the gut microbiota in the etiology of STC.To achieve this goal the investigators characterized and compared the intestinal microbiota among carefully selected patients with constipation that were clinically categorized based on Rome III criteria, and healthy controls using high throughput pyrosequencing of the 16S rRNA gene and a conservative approach to detect quantitative changes in the relative abundances of taxa.


Eligibility Criteria:
Inclusion Criteria:

1. Chronic constipation according to Rome III criteria, defined as two or fewer spontaneous, complete bowel movements (SCBMs) per week for a minimum of 6 months;
2. Age \> 18 years;
3. BMI: 18.5-25 kg/m2;
4. Slow colonic transit confirmed by colonic transit test (colonic transit time (CTT) \> 48 hours);
5. Normal anorectal manometry, with no evidence of dyssynergia and confirmed ability to expel rectal balloon;
6. No radiographic evidence of functional (i.e. pelvic floor dyssynergia) or anatomical (i.e. significant rectocele and intussusception) impediment to the expulsion of the radio-opaque contrast;
7. Disease duration \> 1 year;
8. Traditional treatment with dietary modification, laxatives (including osmotic and stimulant laxatives), and biofeedback tried over the past 6 months without success;

Exclusion Criteria:

1. Bowel constipation due to innate factor (i.e. megacolon) or secondary interventions (i.e. drugs, endocrine, metabolic, neurologic or psychologic disorders);
2. History or evidence of gastrointestinal diseases (i.e. obstruction, cancer, inflammatory bowel diseases) ;
3. Previous abdominal surgery, except cholecystectomy, appendicectomy, tubal ligation and cesarean section;
4. Previous proctological or perianal surgery;
5. A constipation condition meeting the Rome III criteria for IBS or functional abdominal pain syndrome;
6. Pregnant or breast-feeding women;
7. Infection with enteric pathogen;
8. Usage of probiotics, prebiotics and/or synbiotics within the last month;
9. Usage of antibiotics and/or PPIs within the last 3 months;
10. Smoking or alcohol addiction within the last 3 months;
Prevalence of MIH Among Group of Egyptians Children Aged From 8 to 12 in Damietta

Assesment of the prevalence of molar incisor hypomineralization among a group of egyptian children aged from 8 to 12 years old in Damietta governate. This study will determine the severity of molar incisor hypomineralization which will help in its managment ,also will increase the awareness pf pediatric dentists about the prevalence of molar incisor hypomineralization in Egyptian children.Also it will allow the early detection of molar incisor hypomineralization which will make the parents seek early treatment for it. Participants fromprimary schools in Damietta governate will be included in the study. Clinica examination will be carried out in the school lab or in embty class, in day light.


Eligibility Criteria:
Inclusion Criteria:

* positive subject acceptence for participation in the study.
* children aged from 8 to 12 years old.
* Eruption of at least two first permanent molars.
* Both genders.

Exclusion Criteria:

* Uncooperative child.
* Children with prthodontic appliances.
* Children with systemic diseases.
* Children suffering from any other type of enamel defect as enamel hypoplasia.
Monitoring Exhaled Breath to Noninvasively Detect Glycemic Events

The purpose of this study is to determine whether an array of biosensors can noninvasively identify hyperglycemic or hypoglycemic events in persons diagnosed with diabetes through noninvasive detection of volatile organic compounds in exhaled breath.

A device has been developed for sensing volatile organic compounds (VOCs) from human breath. VOCs are chemicals in the air that make up scents and smells, and many VOCs are endogenously produced inside the human body. Trained dogs can smell exhaled breath to determine if someone has diabetes and can even distinguish hypo- or hyperglycemic events (low or high blood sugar). The purpose of this study is to determine if the sensor device can identify hypo- or hyperglycemic events in persons with diabetes through detecting VOCs in breath noninvasively. The data obtained from the VOC sensor will be compared to the information that is also gathered from a continuous glucose monitor (CGM) to establish correlations between blood glucose and exhaled VOC measurements.

Eligibility Criteria:
Inclusion Criteria:

* Who are diagnosed with type 1 diabetes.
* Who are between 12-19 years of age.
* That utilize a Dexcom (G6 or G7) continuous glucose monitoring device.
* That have an established working CGM for at least 12 hours (that does not need to be replaced within 24 hours).
* That are willing to share their daily CGM data for the study.
* That are the only individuals in their household with any type of diabetes diagnosis (type 1 or type 2).
* That are willing to return the device within 24-48 hours of study completion.
* That are located in Indianapolis, IN or its suburban areas.

Exclusion Criteria:

* That are smokers or use tobacco products or who live with someone who smokes in their vicinity.
* That have a condition or abnormality other than type 1 diabetes that in the opinion of the Investigator would compromise the safety of the subject or the quality of the data.
* That utilize closed-loop diabetes management systems.
* That have symptoms or recently been diagnosed with an upper respiratory illness including COVID-19.
* That themselves or a close family member (living within the same household at the time of the data collection period) is on a "ketogenic diet".
* That themselves or a close family member is working in an industry with high and continuous exposure to exogenous VOCs. Examples of such industries include beauty salons and paint manufacturers.
* That are unable or unwilling to cooperate with sample collection.
A Self-compassion Intervention for LGBTQ+ Individuals

Gender and sexual minorities often face minority stress, leading to body dissatisfaction and potential psychological issues like anxiety and depression. Self-compassion has been identified as an effective strategy for managing emotions during negative experiences and may serve as a protective factor against minority stress and body image concerns. However, research on self-compassion interventions specifically for LGBTQ+ individuals is limited. This study aims to evaluate the feasibility, acceptability, and preliminary effectiveness of a self-compassion intervention to enhance body image and psychological well-being among LGBTQ+ individuals in Hong Kong.

Gender and sexual minorities often experience minority stress, which could lead to negative thoughts and feelings of their bodies. The substantial body dissatisfaction may contribute to psychological issues such as anxiety and depression. Self-compassion has emerged as an adaptive methods for regulating emotions in response to negative experience and perceived personal failures. Research indicates that self-compassion could act as protective factors of sexual minority stress and body image concerns. However, there is currently a lack of studies investigating the effectiveness of the self-compassion based intervention in improving body image and psychological outcomes among LGBTQ+ individuals.

The proposed study aims to examine the feasibility, acceptability, and preliminary efficacy of a self-compassion intervention for body image and psychological well-being among lesbian, gay, bisexual, transgender and queer (LGBTQ+) individuals in Hong Kong.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or above;
* Self-identified as LGBTQ+;
* Able to speak, read, and write Cantonese or Putonghua;
* Willing to participate in the study and share their experience of the intervention with the research team;
* Provide written informed consent to participate in the study.

Exclusion Criteria:

* Current psychosis or intellectual disability;
* Current suicidal ideation with intent (score ≥ 4) as measured using the Columbia suicide severity rating scale;
* Participation in similar studies.
Cognitive Effects of Transcranial Direct Current Stimulation in Older Adults

This research is being done to determine whether transcranial direct current stimulation (tDCS) can improve certain mental abilities. In this research, a 9 volt battery is used to deliver very weak electrical current to the surface of the scalp while participants complete cognitive tasks. Our aim is to find out whether tDCS will improve task performance in adults over the age of 55.

Participants enrolled into this study may be asked to do the following:

* Grant permission for the researchers to view medical records associated with their language/cognitive difficulties (if applicable).
* Complete a questionnaire, provide a health history, and take some pencil-and-paper tests of problem-solving and memory in order to verify eligibility to participate and to able to safely undergo the experimental procedures.
* Complete several tasks (i.e., saying words out loud, naming objects, drawing designs, remembering lists of words, searching for images or letters, and/or completing puzzles) based upon a number of cognitive functions such as language, memory, vision, processing, and perception.
* Wear electrodes that will be placed on the scalp with a large rubberized band. These electrodes will administer very weak electrical current (tDCS) from a 9 volt battery for 20 to 60 minutes.
* Participate in several study conditions. The exact conditions and their order will be randomized. Under some conditions, participants may receive active stimulation (tDCS) and under other conditions, they may receive sham stimulation.
* The experimental sessions will last approximately 2 hours and participants may be asked to have more than one testing session in a day or to return for additional sessions.

Eligibility Criteria:
Inclusion Criteria:

* Over the age of 55
* Right Handed
* Native English speaker

Exclusion Criteria:

* History of Seizures
* Any implanted metal device or pacemaker
* Appreciable deficits in hearing or vision
* Greater than 1.5 standard deviations below demographically adjusted means on cognitive screen
* Dementia or Mini Mental Exam below 24
Provision of Antioxidant Therapy in Hemodialysis (PATH) Study

Studies have shown that end stage renal disease (ESRD) patients have higher levels of blood markers which their body makes in response to increased stress and injury. An increase in these markers have been shown to be related to cardiovascular disease and death in ESRD patients. This study will examine whether antioxidant therapy (Vitamin E and alpha lipoic acid) may decrease these markers.

Oxidative stress and acute phase inflammation are now recognized to be highly prevalent in the hemodialysis population, and several lines of evidence point to their contribution in atherosclerosis development. Biomarkers of the inflammatory state such as C-reactive protein (CRP) and interleukin-6 are robust predictors of cardiovascular events and mortality in the dialysis population. The uremic state is characterized by retention of oxidized solutes including reactive aldehyde groups and oxidized thiol groups. It has recently been demonstrated that initiation of maintenance hemodialysis does not improve biomarkers of oxidative stress or inflammation, suggesting that dialysis alone is inadequate to control the atherosclerotic uremic metabolic state. In this study we hypothesize that administration of antioxidant therapy will decrease biomarkers of acute phase inflammation and oxidative stress while improving the erythropoietic response in hemodialysis patients.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with end-stage renal disease receiving thrice weekly hemodialysis
2. Age \> 18 years
3. Life expectancy greater than one year
4. Ability to understand and provide informed consent for participation in the study

Exclusion Criteria:

1. AIDS (HIV seropositivity is not an exclusion criteria)
2. Active malignancy excluding basal cell carcinoma of the skin
3. Gastrointestinal dysfunction requiring parenteral nutrition
4. History of functional kidney transplant \< 6 months prior to study entry
5. Anticipated live donor kidney transplant over study duration
6. History of poor adherence to hemodialysis or medical regimen
7. Prisoners, patients with significant mental illness, pregnant women, and other vulnerable populations
8. Patients taking vitamin E supplements \> 60 IU/day, vitamin C \> 500 mg/day over the past 30 days
9. Patients taking anti-inflammatory medication except aspirin \< 325 mg/day over the past 30 days
10. Patients using a temporary catheter for dialysis access
11. More than two hospitalizations within the last 90 days or one hospitalization within the last 30 days
Acupuncture Therapy for Post-stroke Mild Cognitive Impairment: a Randomized Controlled Trial

1. On the basis of previous studies, standardized randomized controlled clinical trials were conducted to observe the efficacy and safety of acupuncture in the treatment of mild cognitive impairment after stroke using the international rating scale, and the clinical experience was transformed into evidence.
2. According to the clinical outcomes reported by patients, the differences between Chinese and western scales in evaluating mild cognitive impairment after stroke were compared. On the basis of "disease differentiation, syndrome differentiation and meridian differentiation", the syndrome differentiation and treatment system of mild cognitive impairment after stroke was preliminarily constructed, and the TCM syndrome prediction model was improved.


Eligibility Criteria:
Inclusion Criteria:

1. Meeting the diagnostic criteria: ① Stroke diagnostic criteria: according to the diagnostic criteria of cerebral infarction and cerebral hemorrhage in the "Chinese Guidelines for the Prevention and Treatment of Stroke (2021 edition)" issued by the National Health Commission, the diagnosis was confirmed by head CT or MRI examination. ② Mild cognitive impairment diagnostic criteria: according to the 2018 Chinese Guidelines for the Diagnosis and Treatment of Dementia and cognitive Impairment (5) : Diagnosis and treatment of mild cognitive Impairment. ③ TCM diagnostic criteria: according to the "TCM Diagnostic Efficacy Criteria" issued by the State Administration of Traditional Chinese Medicine in 2012, the patients were diagnosed as dementia.
2. 40 years old ≤ age ≤75 years old, regardless of gender;
3. cognitive impairment occurred after stroke without other causes;
4. cognitive impairment within 6 months after stroke;
5. stable condition, clear consciousness, MoCA score \< 26 points;
6. those who were willing to participate in the study and signed the "informed consent".

Exclusion Criteria:

* Brain CT or MRI showed other lesions unrelated to stroke, or severe brain atrophy or leukoaraiosis; (2) serious complications (myocardial infarction, heart failure, malignant tumor, severe infection, mental illness, severe depression, epilepsy, etc.);

  * with obvious hearing impairment, visual impairment, aphasia and other inability to cooperate in the physical evaluation; (4) pregnant or intended to pregnant women, lactating women; ⑤ intolerance to acupuncture; ⑥ bleeding tendency and poor coagulation function.
Magnetic Resonance Elastography of Transplanted Kidney (GREFFE_ELASTO IRM)

: GREFFE_ELASTO IRM will evaluate Magnetic Resonance Elastography (MRE) in renal transplant patients with suspected interstitial fibrosis/tubular atrophy lesions requiring biopsy graft sampling under ultrasound control.

The main objective is to search a correlation between renal graft parenchymal elasticity values obtained in vivo by MRE, and the histological data of renal fibrosis by biopsy sampling, and providing a non-invasive tool capable of detecting and monitoring this development over time, making possible in the future to reduce the number of renal biopsies.

The natural history of interstitial fibrosis/tubular atrophy (IF/TA) is a common mechanism of disease progression of transplanted kidneys. The process has been well studied through protocol biopsies. The early phase is characterized by fibrogenesis and the emergence of tubulo-interstitial damage due to immunologic phenomena; the late phase is characterized by the worsening of parenchymal lesions and the occurrence of glomerular sclerosis leading to graft loss.

Today, non-invasive markers of these pathological changes are missing and the protocol biopsies are still the only reliable tool for the diagnosis of IF/TA.

Elasticity imaging has already been proven in the management of chronic liver diseases with Fibroscan. In the field of renal diseases, several studies have been carried out in ultrasound elastography on renal grafts but the renal elastography is more difficult due to the complexity of the kidney (deep organ, two compartments, high vascularity). All these parameters have an influence on the elasticity measures.

The elastography imaging is also performed in MRI (Magnetic resonance imaging): The Magnetic Resonance Elastography (MRE). MRE is less subject to variations in depth, to the experience of the operator and to allow an overall evaluation of the graft.

The potentially eligible patients will be recruited by the nephrologist during a consultation in which renal biopsy is scheduled (as part of current practice). Patients meeting the inclusion criteria and having no exclusion criteria will be offered to participate in this study. If accepted, the only examination specific to this research, the MRE, will be scheduled to be performed the same day as the renal biopsy.

This MRE is painless, non-irradiating, and does not require the injection of contrast medium.

The participation of the patient ends when he leaves the hospital after the biopsy procedure.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18yrs;
* Transplanted kidney patient with suspicion of IF/TA lesions requiring biopsy graft sampling under ultrasound control;
* Signed informed consent;
* Affiliated or beneficiary of health insurance

Exclusion Criteria:

* Patients with dilated pyelocaliceal cavities on ultrasound or significant renal artery stenosis (\> 80%) on Doppler;
* Pregnant or nursing women;
* Contraindications to MRI;
* Person deprived of liberty, major who is the subject of a legal protection measure or unable to express consent
ZK283197 for Treatment of Vasomotor Symptoms

The primary goal of the planned study is to investigate the efficacy and safety of ZK 283197 in the dosage of 2 and 3 mg ingested once daily during a period of 8 weeks for the treatment of hot flushes. In order to be able to assess the efficacy of the test substance, this is compared with the efficacy of 1 mg Estradiol and placebo. The comparator Estradiol is a certified hormone preparation, which is already used for the treatment of hot flushes as standard treatment. After passing the screening, volunteers will start with a run-in phase followed by a 8 weeks treatment and a follow-up phase. 112 postmenopausal women with hot flushes and without relevant prior diseases will participate in three European countries (2 study sites in Germany, 1 study site in Great Britain and 1 study site in The Netherlands) in this study.


Eligibility Criteria:
Inclusion Criteria:

* Women with at least 35 moderate to severe hot flushes in seven consecutive days
* Body mass index (BMI) : 20 - 30 kg/m² (inclusive)
* Postmenopausal status

Exclusion Criteria:

* Contraindication for use for hormonal therapy
* Prior hysterectomy
* Hormonal therapy or intrauterine hormone releasing device within 4 weeks prior to study entry or any long-acting injectable or implant up to 6 months prior to study entry
* Repeated intake of medications affecting study aim
New Validated Recipes for Double-blind Placebo-controlled Low Dose Food Challenges

This study aimed to validate new recipes for cow's milk, hen's egg, soy, cod and wheat, to be used in blinded low-dose food challenges.


Eligibility Criteria:
Inclusion Criteria:

* Children belonging to one of two age groups: 7-8 years or 14-15 years
* No previous hypersensitivity reaction to the food to be tested
* Capacity to understand the test instructions and to participate in the test sessions

Exclusion Criteria:

* Children not belonging to one of the two age groups: 7-8 years or 14-15 years
* One or more previous hypersensitivity reaction to the food to be tested
* Unability to understand the test instructions and to participate in the test sessions