cyrilzakka/clinical-trials huggingface dataset:
A Prolongation of a Clinical Study to Evaluate the Efficacy of an Aqueous Gel Containing 2% (w/w) of Cidofovir, Directly Applied on the Cervix Exhibiting High Grade Squamous Intraepithelial Lesions.

The infections of high grade induced by the human papilloma viruses cause precancerous lesions of the cervical epithelium. The progression of these lesions can lead to the onset of cervical cancer. To reduce the risk of cancer lesions classified as 'cervical squamous intraepithelial neoplasia 2' (CIN2) and 'cervical squamous intraepithelial neoplasia 3' (CIN3), the standard treatment is the conisation of the cervix. This surgery can lead to complications such as infertility or a risk of preterm birth, hence the need to move towards a non-surgical alternative therapy.

The colvir clinical trial was a phase-II, multi center, randomized, double blind, efficacy study of an aqueous gel containing 2% (w/w) cidofovir, administrated directly on cervix exhibiting high grade squamous intraepithelial lesion (CIN 2 and 3).

This clinical trial is a prolongation of the colvir trial, in order to

* assess the long term histological and virological evolution (24 months) of 3 g of 2% (w/w) cidofovir gel, administrated directly on cervix exhibiting high grade intraepithelial neoplasia after complete response, partial response or response failure at the end of the Colvir study.
* assess the long term (24 months) rate of recurrence of histological lesions of the Colvir patients after conisation, in both placebo and treatment groups.


Eligibility Criteria:
Inclusion Criteria:

* Women who participated in the COLVIR study and received complete treatment

Exclusion Criteria:

* Women from the Colvir study who received incomplete treatment
Simultaneous Coronary Artery Evaluation and Lung Cancer CT Screening

Cardiac computed tomography (CT) is often performed in patients who are at high risk for lung cancer in whom screening is currently recommended. This pilot randomized study will test the feasibility, safety and diagnostic ability of a novel ultra-low-dose CT protocol that allows concomitant coronary artery evaluation and lung screening. Current or former heavy smoker subjects with suspected or known coronary artery disease will be randomized to undergo CT assessment of either thoracic area only or both coronary arteries and thoracic area. Primary end-points will be the effective contrast and radiation doses.

Cardiac computed tomography (CT) scan is an ideal diagnostic tool for identifying coronary artery disease in patients with low or intermediate risk. In recent years, cardiac CT is being often performed in patients who are at high risk either for coronary artery disease or lung cancer. The update edition of the National Institute for Health and Care Excellence (NICE) guidelines recommends cardiac CT as the first-line diagnostic tool for patients with new-onset chest pain due to suspected coronary artery disease. Also, symptomatic patients with known coronary artery disease and previous percutaneous coronary intervention who have an unclear stress test but whose presentation suggests a high likelihood of having an in-stent restenosis or a 'de novo' stenosis might benefit from cardiac CT. In 2014, the U.S. Preventive Services Task Force recommended annual lung cancer screening with ultra-low dose computed tomography for current and former heavy smokers aged 55 to 80 years. Indeed, lung cancer screening in patients with suspected or known coronary artery disease undergoing cardiac CT may provide the opportunity to implement recommendation for lung cancer screening in clinical practice.This pilot randomized study will test the feasibility, safety and diagnostic ability of a novel ultra-low-dose CT protocol that allows concomitant coronary artery evaluation and lung screening. Current or former heavy smoker subjects with suspected or known coronary artery disease will be randomized to undergo CT assessment of either thoracic area only or both coronary arteries and thoracic area. Primary end-points will be the effective contrast and radiation doses.

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic subjects with effort-induced or typical chest pain
* High probability of coronary artery disease
* Known coronary artery disease
* Willing to participate to the study
* Informed consent to undergo CT scan

Exclusion Criteria:

* Contraindications to iodinated contrast such as allergies and chronic kidney failure
* Any suspicion of pregnancy
Effects of Yoghurt Consumption on Glucose Metabolism in Prediabetic Subjects

The purpose of this study is to explore the effects of yoghurt consumption on glucose metabolism in prediabetic subjects.

Study population: the study population will consist of 60 (30 per group) subjects (men and women) at high risk of type 2 diabetes mellitus (T2DM), aged 18-65 years (inclusive), body mass index (BMI) 25.0 (inclusive) - 35.0 kg/m2 (exclusive), diagnosed with prediabetes, defined as fasting plasma glucose levels 100-125 mg/dL (5.6-6.9 mmol/L) (inclusive), randomised in a test and control group.

Intervention comprises of two study periods: a refrain period from dairy products and pro-, pre- and synbiotic supplements in any form, for 2 weeks, followed by an intervention period of 24 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Signed ICF
2. Male/Female 18-65 years
3. BMI 25-35 kg/m2
4. FPG 100-125 mg/dL
5. At least one relative with T2DM
6. BW maintained (\<3%)
7. Female postmenopausal or sterile or using contraceptive method
8. Ability to comply with study protocol form
9. Access to a refrigerator at home for study products storage
10. Ability to collect and store stool samples
11. Coverage by French health insurance
12. Agreement to be registered in the national database of subjects participating in clinical research
13. Ability to complete ePRO
14. FPG 100-125 mg/dL at randomisation visit

Exclusion Criteria:

1. Diagnosis of T2DM, T1DM, or on antidiabetic medications
2. Medications or supplements affecting gut microbiota or causing hyperglycemia
3. Systemic antibiotic treatment
4. Treatment interfering with BW and bariatric surgery
5. Liver, renal, cardiovascular, respiratory, endocrine, metabolic disorders, or iatrogenic immunodeficiency
6. Chronic gastro-intestinal disorders or recent use of laxatives
7. Recent surgery or general anesthesia
8. Donation/Loss of blood
9. Inability to comply with dietary restriction
10. Allergy or intolerance to study product ingredients
11. Excessive consumption of alcohol
12. Smoker
13. Pregnancy, breast-feeding or change in contraceptive methods
14. Situation interfering with optimal participation
15. Participation in other clinical study
16. Living in the same home as another participant
17. Employees, family members of Danone
Cognitive Training Cerebral Palsy

This study aims to conduct a single-blind randomized controlled trial with sixty children with Cerebral Palsy (CP) to explore if a home-based computerized multi-modal executive training is effective improving infants' executive functions (EF), as the primary outcome. As secondary outcomes, it will be tested if the intervention exerts a positive effect on other cognitive functions, social relationships, and quality of life (QOL) in children with CP. It is expected to observe changes in brain structure and functioning associated to clinical improvements.

The primary hypothesis to be tested is that a computerized multi-modal cognitive training will be more effective at improving EF than usual care alone.

Secondary hypotheses are that the computerized therapy will be more effective than usual care alone at improving specific cognitive functions such as visuoperception, memory, social relationships and QOL. In addition, we also hypothesize there will be changes on brain structure and function. We further hypothesise that these changes will be maintained over time (9 months). Finally, sociodemographic and clinical factors are expected to be related with the level of efficacy of the computerized multi-modal cognitive training.


Eligibility Criteria:
Inclusion Criteria:

* Aged 8-12 years.
* Manual Abilities Classification scale (MACs) ranging from I to III.
* An intelligible yes/no response system.
* Being able to understand simple instructions.
* Having the possibility of participating in the investigation for one year.
* Being able to access to internet at home.

Exclusion Criteria:

* Identified hearing or visual impairment that precludes neuropsychological assessment and training.
Study of the Value of Using a Honey Dressing Compared to the Use of a Standard Dressing on the Toe Amputation Wound in the Diabetic Patient

Numerous scientific publications in France and internationally have described the healing, anti-bacterial, anti-oxidant, anti-inflammatory and immuno-modulating properties of honey.

Honey is effective in the management of many infected or uninfected post-surgical wounds.

This study focuses on post surgical wounds after toe amputation in diabetic patients.

The main objective of this study is to compare the rate of epidermisation at six months for these wounds, between honey dressing and other dressing devices used according to the french Haute Autorité de Santé (HAS) recommendations


Eligibility Criteria:
Inclusion Criteria:

* Diabetic patients
* Patients who have had an amputation of one or more toes within four days prior to inclusion without having the second dressing rehabilitated
* Written informed consent.

Exclusion Criteria:

* Known hypersensitivity to honey, hyaluronic acid, guar gum, pectin and/or zinc oxide.
* Insipid Diabètes
* patient eligible for a dressing by Vacuum Assisted Closure therapy (VAC therapy)
* transmetatarsal amputation
* Patient with sutured wound
* Patient already included in the study, for a previous amputation for wich the wound has not healed.
* Failure to comply with protocol requirements
* Person protect by article L1121-5 to L1121-8 of the French Health Public.
* Patient include in an other clinical study
Proton Radiation Therapy for Invasive Breast Cancer Following Mastectomy

In this study we are looking at a type of radiation called proton radiation which is known to spare surrounding tissue and organs from radiation. The proton radiation will be delivered using 3D conformal proton radiation or scanned beam/IMPT (Intensity Modulated Proton Radiation Treatment). Proton radiation delivers no dose beyond the region requiring treatment. This may reduce side effects that patients would normally experience with conventional radiation therapy or other means of delivering proton radiation therapy. In this study we are evaluating the effectiveness of using proton radiation delivered to reduce side effects association with radiation treatment.

Proton radiation will be delivered daily for approximately 5 1/2 weeks. Patients will be assessed weekly for any side effects they may be experiencing.

Patients will have follow-up visits 4 weeks after proton therapy ends, at 6 months, 12 months, and then every year for up to five years after treatment. Follow-up visits will include a physical examination, radiological imaging (if necessary), echocardiogram, and laboratory tests.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed invasive breast cancer confined to the breast and regional lymphatics
* Completed mastectomy (complete not partial )breast surgery +/- reconstructive surgery
* Life expectancy \> 12 months

Exclusion Criteria:

* Pregnant or breast-feeding
* Prior therapeutic radiation \> 200 cGy
* History of a different malignancy unless disease-free for at least 5 years or diagnosed and treated cervical cancer in situ, or basal or squamous cell cancer of the skin
* Prior investigation chemotherapy
Effectiveness of Foot Exercise People With Type 2 Diabetes

The aim of this study will to investigate the effect of foot exercises in patients with type 2 diabetic and peripheral neuropathy. Subjects will be randomly allocated to either the control or intervention group. Data will be collected using investigator-developed forms: patient information form and the diabetic foot exercises log. Patients in the intervention group will be received standard treatment and performed foot exercises for three times a week 8 weeks; the control group will be received standard treatment but no exercises. The intervention and control groups will be examined and measured at the 4th and 8th weeks.

Purpose of our study investigation of the effects foot exercises in patients with type 2 diabetic and peripheral neuropathy.

Excepted results: Routine treatment + foot exercises pain, flexibility, edema, muscle strength, sensation, quality of life we believe that there will be good progress in peripheral neuropathy effects, Leeds assessment of neuropathic symptoms and signs(LANSS) results.

In this context, it is planned that patients randomly divided into 2 groups. Group 1 control group. Group 2 intervention group. Patients in the intervention group will be received standard treatment and performed foot exercises for three times a week 8 weeks. The patients will be evaluated by clinical measurements and scales based on patient notification at the 4th and 8th weeks.

Eligibility Criteria:
Inclusion Criteria:

* Having type 2 diabetes mellitus for 5 years
* HbA1c \> among of between 6.5-10
* Having grade 0 or 1 phase of Wagner classification
* Diabetic neuropathy score ≥ 3

Exclusion Criteria:

* Not to know turkish
* Having hearing, visual and speaking problems
* Having (except diabetic neuropathy) other neurologic problems
* Having psychiatric and cognitive problems
* Having orthopedic, rheumatologic, cardiac, and pulmonary problems which stopping exercise
A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Autism

This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records regarding autism.

The goal of this Research Study is to better understand how the genetic information in subject's microbiome correlates to the information provided in surveys and in medical records regarding autism.

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent by parent or legally authorized representative
2. Male or female patients age 6 and older.
3. Diagnosis of autism per DSM-V criteria (See appendix)

Exclusion Criteria:

1. Refusal by parent or legally authorized representative to sign informed consent form
2. Treatment with antibiotics within 2 weeks prior to screening
3. Treatment with probiotics within 6 weeks prior to screening
4. History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy.
5. Postoperative stoma, ostomy, or ileoanal pouch
6. Participation in any experimental drug protocol within the past 12 weeks
7. Treatment with total parenteral nutrition
8. Any clinically significant evidence of disease that could interfere with the subject's ability to enter the trial
9. Inability of parent or legally authorized representative to adequately communicate with the investigator or their respective designee and/or comply with the requirements of the entire study
The Intermediate and Long-term Follow up of Home Based Pelvic Muscle Training

When participants present with symptoms of pelvic organ prolapse (POP) and stress urinary incontinence (SUI), the investigators will perform a comprehensive evaluation and initially provide conservative treatment. If conservative treatment fails, invasive treatment will be considered. The investigators will arrange a pelvic muscle training course two to three times a week for a duration of 1.5 months per course. However, participants may complain about the inconvenience of traffic, which may lead to discontinuation of the pelvic training course. Therefore, the investigators propose the development of a home-based pelvic muscle training device and will collaborate with information engineering specialists at Tamkang University to invent the device for home-based pelvic muscle training.

The investigators will enroll participants with SUI or POP and allocate them into either the home-based pelvic floor muscle training (PFMT) group or traditional PFMT group. Participant satisfaction will be evaluated using a questionnaire score.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18-year-old, non-pregnancy, SUI, bladder capacity \> 300ml, RU\<150ml, pelvic organ prolapse

Exclusion Criteria:

* recurrent UTI, cancer patients, chronic pelvic pain, psychologic problems
Hyponatremia and Myometrium Contractility. An Invitro Study

Hyponatremia during labour has been associated with prolonged labour, and increased incidence of instrumental delivery and emergency caesarean section. Sodium influx in myometral cells are involved in contractility,and and influence of hyponatraemia on contractility can be suspected.

Biopsies will be obtained from pregnant women undergoing planned caesarean section at term. The biopsies will divided into 3 strips that will be stored overnight in chilled NaCl 0.9%. The following morning each strip will be mounted isometrically with one end fixed to a holder and the other end to a force transducer. One strip will be maintained in a solution containing 140mmol/L Na,acting as control, whereas the other two strips will be placed in fluids with diminishing Na concentration, from 140 mmol/L, to 130 mmol/L and 120 mmol/L. Contractility will be measured with force transducers and a polygraph

Eligibility Criteria:
Inclusion Criteria:

* Singleton pregnancy at term

Exclusion Criteria:

* Preeclampsia
The Effective and Safety of Thalidomide in NTDT

This is an exploratory experiment, aims to explore the effective and safety of thalidomide in the treatment of NTDT to improve the hemoglobin level, improve the quality of life, reduce blood transfusion, so as to avoid the adverse reactions caused by transfusion.15\~30 patients will be enrolled, including type α 5\~13 cases, type β 10\~17 cases.

The project is a single arm research of thalidomide in NTDT,patients volunteered to participate in this trial and met the following inclusion criteria will be enrolled: age from 18\~65, Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less. Subjects should take thalidomide 50mg per day for 12 weeks. During this time, hepatic and renal function, hematologic function, electrocardiogram and the adverse reactions were closely observed. According to the protocol, the blood routine, peripheral blood reticulocyte count, nucleated red blood cell count, hemoglobin electrophoresis and other indicators were evaluated in screening-period visit, 4-weeks visit, 8-weeks visit and 12-weeks visit.

Eligibility Criteria:
Inclusion Criteria:

Patients meeting all of the following criteria will be considered for admission to the trial:

* Diagnosis of NTDT;
* Ages 18-65 years;
* ECOG: 0\~2 scores;
* Sign an informed consent agreeing to the clinical trial participation.

Exclusion Criteria:

Patients presenting with any of the following criteria will not be included in the trial:

* Patients received hydroxycarbamide, Yisui Shengxue Granule in three months;
* Women during Pregnancy, breastfeeding or those of childbearing age who do not want to take contraceptive measures;
* Patients had comorbidities like severe heart or lung diseases, liver dysfunction, cerebrovascular, cardiovascular, liver, kidney, tumor or other serious primary diseases;
* Patients Allergic to the drug ingredients;
* Patients with any Mental problem;
* Patients had Participated in other drug clinical trials in the past 1 month;
* Patients had a history of venous or arterial thrombosis;
* In certain circumstances that the researchers determined it was not suitable for the research.
The Effects of External Nasal Dilator Strips on Sleep and Cardiovascular Health

The goal of this interventional study is to learn if wearing an external nasal dilator strip while sleeping changes objective and perceived sleep quality, immediate post-waking blood pressure, and immediate-post waking heart rate variability.

Nasal dilator strips are strips often made up of stiff plastic, placed on the lower bridge of the nose by an adhesive strip. They work by slightly pulling the nostrils and surrounding nose bridge area outward, dilating the nostrils, and decreasing air resistance. Nasal breathing is associated with lower diastolic blood pressure, an important marker of heart health, in comparison to mouth breathing. In addition to blood pressure, nasal breathing during sleep is potentially related with better sleep quality. Participating in this study will help us understand the effect nasal dilator strips have on cardiovascular and sleep health. Better understanding of the benefits of nasal dilator strips will provide important knowledge to researchers who study how the body works.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-30
* BMI \<30
* Has a smartphone and is willing to download EliteHRV and OMRON mobile applications.
* Able to use a nasal dilator strip

Exclusion Criteria:

* Overt cardiovascular (e.g., diagnosed hypertension), respiratory, neurological, renal, liver, and/or metabolic health conditions.
* Current or recent (regular use within the past 6 months) use of tobacco or nicotine products (e.g., cigarettes).
* Currently pregnant, trying to become pregnant, or lactating.
* Inability to breathe through the nose.
Effect of Lower Limb Exproprioception Training in Virtual Environment on Locomotion Performance in Stroke Patients

The purpose of this study is to determine if a virtual reality training of foot placement with or without visual cues about the location of the foot in the environment would improve locomotion-related function in persons in the chronic stage of stroke. Participants were randomly assigned to receive twice per week, for a total of 2 weeks' training with visual cues (control group) or without (experimental group). It was hypothesized that the experimental group would be able to place the foot closer to the target when stepping and have more symmetrical gait. So far, 22 stroke patients completed the experiment. Preliminary results support the hypothesis. This project is still ongoing.


Eligibility Criteria:
Inclusion Criteria:

* first time unilateral stroke and onset over 6 months
* able to independent walking with or without aids over 10 meters
* Mini-Mental State Examination (MMSE) score above 24
* orientation intake, able to identify right and left
* normal or corrected-to-normal vision, able to see the 2 cm diameter circle on the floor while standing

Exclusion Criteria:

* gait nearly normal
* had other neurological and musculoskeletal disease which can affect walking ability
* hemineglect
* use virtual reality device will severely discomfort, such as headaches, blurred vision, vertigo or vomiting