cyrilzakka/clinical-trials huggingface dataset:
"Underwater" Technique With Submucosal Solution of Viscose Solution -SIC 8000 (EleviewTM) - For Endoscopic Resection of Cole-rectal Polyps With Signs of Fibrosis.

All procedures are performed in the investigator's outpatient gastroenterology and digestive endoscopy unit by experienced endoscopists in conventional mucosectomies of the lower intestinal tract.

Before the procedure each patient, a normal endoscopic procedure. At the site of the lesion the lumen will be completely decompressed with aspiration of the gas, and then again relaxed with the instillation of only water. The EleviewTM will be injected into the submucosa in such quantities as to obtain a satisfactory lift of the lesion. The lesion will then be removed with a diathermic loop, preferably en-bloc, and in any case up to macroscopic evidence of complete resection. All the removed material will be stored and sent to histological analysis. Tolerability score will be recorded during the procedure.

Any "bleeding" (both intra- and post-procedural), perforation, post-polypectomy syndrome, stenosis or death in the 6 months following the procedure will be born "complication".

A surveillance colonoscopy including biopsy sampling of the research site scheduled 6 months after the procedure


Eligibility Criteria:
Inclusion Criteria:

* Age\> 18 years.
* Signing of informed consent.
* Possibility of being subjected to the diagnostic and therapeutic procedures of the study.
* Presence of colo-rectal polypoid lesions ≥ 15mm presenting macroscopic aspects of fibrosis as a consequence of previous incomplete treatments or biopsies or relapses after previous removal.

Exclusion Criteria:

* Highly indicative morphological characteristics of carcinoma with submucosal invasion (Ulceration, Pit Pattern Vn according to Kudo et al.18)
* Pregnancy or breastfeeding
* ASA\> 3
* Unstable personality or unable to adhere to the protocol procedures.
* Inability to provide informed consent.
* Injury not reachable endoscopically.
Evaluate the Safety, Efficacy, and Pharmacokinetics of CRN04894 in Participants With Congenital Adrenal Hyperplasia (TouCAHn)

The purpose of this Phase 2, open-label, sequential dose cohort study is to evaluate the safety, efficacy, and pharmacokinetics (PK) of CRN04894 in participants with classic congenital adrenal hyperplasia (CAH) caused by 21-hydroxylase deficiency.

This Phase 2, open-label, sequential dose cohort study will evaluate the efficacy, safety, PK, and PD of CRN04894 when administered for 12 weeks in participants with CAH caused by 21-hydroxylase deficiency. Up to approximately 30 participants will be enrolled in the study.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female participants ≥18 to 75 years of age at the time of signing the Informed Consent Form (ICF). Participants ≥16 years of age may be included in sites located in the United States
2. Classic 21-hydroxylase deficiency
3. On a stable regimen of glucocorticoid replacement (eg, hydrocortisone, prednisolone, prednisone, methylprednisolone)
4. Compliance with glucocorticoid replacement and mineralocorticoid replacement (if applicable) regimen during the Screening Period
5. Minimum total daily dose of ≥15 mg hydrocortisone (or equivalent). For Cohort 4, a mean daily dose of ≥11 mg/m²/day of hydrocortisone or hydrocortisone equivalents will be used for inclusion
6. If on estrogen therapy (any route), dose must be stable for at least 3 months prior to Screening

Exclusion Criteria:

1. Diagnosis of any other form of CAH other than classic 21-hydroxylase deficiency
2. Dexamethasone use within 30 days of Screening for Cohorts 1-3. In Cohort 4, dexamethasone is permitted
3. History of bilateral adrenalectomy, hypopituitarism, or other condition requiring chronic glucocorticoid therapy
4. Night shift workers or any other reason for abnormal sleep/wake cycles
5. Clinically significant unstable medical condition or chronic disease other than CAH
6. History of major surgery/surgical therapy for any cause within 4 weeks prior to Screening
7. Diabetes mellitus treated with insulin for less than 6 weeks prior to Screening, or with change in total daily insulin dose by \>15% within 6 weeks prior to Screening
8. Poorly controlled diabetes mellitus defined as having a hemoglobin A1c (HbA1c) ≥8.5%(≥69 mmol/mL), or estimated HbA1c based on fructosamine if HbA1c is not evaluable (eg, due to hemoglobinopathies)
9. Participants with hypothyroidism who are not receiving adequate hormone replacement therapy based on thyroid hormone levels measured at the time of Screening
10. History of unstable angina or acute myocardial infarction within 12 weeks prior to Screening or other clinically significant cardiac disease at the time of Screening
11. History of cancer excluding cured/treated dermal squamous or basal cell carcinoma or cervical carcinoma in situ
12. Pregnant or lactating
13. Known history of illicit drug or alcohol abuse within the last year
14. Use of antiandrogen therapy in the past 3 months (eg, spironolactone, finasteride, cyproterone acetate, flutamide)
15. Use of testosterone, androgen-containing supplements, aromatase inhibitors, or growth hormone
Effect of Olixia Pure® Eye Drops on Tear Film Thickness in Healthy Subjects

Dry eye syndrome (DES) is a common ocular disease, especially in the elderly population. Despite many treatment approaches, instillation of topical lubricants remains the mainstay of therapy. However, most of the topical lubricants available are not very well characterized and data about efficacy is sparse.

The aim of the present project is to investigate the effect of topically administered Olixia pure® eye drops on tear film thickness in healthy subjects.

Tear film thickness will be determined using ultra high-resolution optical coherence tomography (OCT). Measurements will be performed before instillation of the eye drops and every 10 minutes after instillation for one hour. One eye will receive Olixia pure® eye drops, the fellow eye will receive physiologic saline solution as placebo control. The study eye will be chosen randomly.


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged over 18 years
* Normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant
* Normal ophthalmic findings, ametropia \< 6 Dpt.
* Schirmer I test \> 10 mm and BUT \> 10 sec

Exclusion Criteria:

* Regular use of medication (except contraceptives), abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
* Treatment in the previous 3 weeks with any drug
* Symptoms of a clinically relevant illness in the 3 weeks before the first study day
* Ametropia =/\> 6 Dpt
* Pregnancy
* Difference of more than 5 mm in Schirmer I test or difference of \> 3 sec in BUT between the two eyes
* Known medical history of allergy, hypersensitivity or poor tolerance to any components of the medication or medical product used in the study
Gut Microbiota and Sepsis-associated Acute Kidney Injury

Sepsis has emerged as one of the important life-threatening infectious diseases with high morbidity and mortality. Sepsis-associated kidney injury (SAKI) is one of the most common and serious complications of sepsis. It has been found that intestinal flora may affect the occurrence and development of a variety of diseases, and may also affect the pathogenesis of multiple SAKI, which is also regulated by host genetic factors. Therefore, the investigators speculate that gut microbiota composition may be associated with susceptibility to SAKI, and there are no studies reporting the association between gut microbiota and SAKI. The investigators intend to carry out a multicenter study in conjunction with the Department of Intensive Care of Qinghai Provincial People's Hospital. The structure and function of intestinal flora in septic patients with renal injury and septic patients less susceptible to renal injury are studied by 16S rDNA amplicon sequencing technology. The differences in composition, diversity and structural stability of intestinal flora between the two groups are analyzed to explore the genera that play a key role in the occurrence of the disease. By analyzing the differences between renal injury and inflammation levels in each group, the correlation between intestinal flora and SAKI, the possible influencing links involved, and the related factors affecting the prognosis of SAKI were revealed. The results of this study are helpful to further elucidate the pathogenesis of SAKI and provide new ideas and methods for the prevention and treatment of SAKI.


Eligibility Criteria:
Inclusion Criteria:

* Age≥18 years；Meet the sepsis definition and diagnostic criteria of Sepsis-3.0 guidelines；No previous history of hypertension or diabetes; No underlying kidney disease such as nephrotic syndrome, no history of rheumatic immune system disease; Normal renal function before onset.

Exclusion Criteria:

* Patients with hypertension, diabetes, coronary heart disease, tumor, rheumatism immune system disease and other related diseases that may cause kidney injury; Patients with abnormal renal function before onset; Patients with nephrotic syndrome and other underlying kidney disease; Long-term oral administration of drugs with kidney injury; Previous history of gastrointestinal surgery; No diarrhea related diseases or other gastrointestinal diseases in the past 1 month; The use of antibiotics and probiotics in the past 1 month; Exclusion of other primary or secondary renal damage factors.
Determination of the Biological Activity of Serum From Patients

The main objective of the study is to determine the influence of patient sera before and after probiotic intervention on the behavior of bone cells (osteoblasts and osteoclasts).

The secondary objectives are to assess the activity of bone cells and the course of rheumatoid arthritis before and after the consomption of probiotics.

The written consent of the subjects will be obtained after full information of the aims, nature and possible risks of the study.

Before inclusion, subjects will undergo a medical check-up including an interview on personal and family history and drug treatments taken as well as a standard medical examination including weight, height and blood pressure measurement. . Their compliance with the inclusion / exclusion criteria will be verified during this review. An interview with personnel involved in the research (a dietician / study Research clinic assistant, etc.) will also be carried out as well as a biological selection assessment.

As part of this study, the subjects will come a total of 7 times to the Emile ROUX hospital in Le Puy en Velay.

The probiotic treatment will begin between 1 and 3 weeks after the inclusion visit. The volunteers / patients recruited will have a volume of blood sampled and a stool collected before the start of the probiotic treatment (T = 0) and at the end of the treatment (T = 4 weeks). The study consists of three periods of probiotic treatment of 4 weeks each interspersed with a wash-out period of 3 weeks in accordance with the recovery period necessary between two blood samples.

The sera thus obtained will then be analyzed to determine their biological activity with regard to the induction of changes in the behavior of bone cell models: osteoformin cells (osteoblasts) and osteo-resorbent cells (osteoclasts).

Eligibility Criteria:
Inclusion Criteria:

Women

* 30-75 years
* Non-menopausal or menopausal for more than 2 years because the tissue osteoarticular is under the influence of steroid hormones. Peri-menopause is accompanied by strong hormonal variations.
* With rheumatoid arthritis (DAS28 threshold specified below)
* Clinical arthritis score ≥ 2.6 (DAS28). Pathology needs to be characterized even if the score remains low
* Person with good venous condition

Exclusion Criteria:

Vaccination in the last two months

* Alcohol abuse with regard to WHO standards
* Smoking (\>5 cigarettes/day)

  -\> 5 hours of intense sport per week
* Food allergy and others
* Antibiotic treatment in the month preceding inclusion
* Persons under guardianship, curators, deprived of liberties, safeguard of justice
* Refusal to sign the information and consent form
Study: Treatment of Relapsed Lymphoid Malignancies With an Anti-Angiogenic Approach

1.1 To determine the efficacy of a combination treatment of VP-16, chlorambucil, dexamethasone, and vincristine in patients with relapsed/refractory hematological malignancies.

1.2 To determine the toxicity profile of the above regimen in this patient population.

1.3 Evaluate the effect of low dose administration of chemotherapy on angiogenesis, and correlate this with tumor responses.

The purpose of the study is to see how effective the combination of chemotherapy drugs VP-16, chlorambucil, dexamethasone, and vincristine is for patients who have blood cancers that have returned or not responded to prior treatment. Some patients may also receive a medication called rituximab if their doctor thinks it is appropriate. This drug combination will be given to study participants in a low dose continuous basis. The study will also collect information about the side effects of the above drug combination on patients with these types of cancers. Previous studies on patients with non-Hodgkin's lymphoma indicate that some patients treated with this drug combination achieved a high response. The aim of this study is to test this drug combination in a controlled setting.

Eligibility Criteria:
Inclusion Criteria:

* All patients, 18 years of age or older, with Hodgkin's lymphoma, Non-Hodgkin lymphoma (NHL), multiple myeloma (MM), or chronic lymphocytic leukemia (CLL) are eligible.
* Patients must have a life expectancy of at least 12 weeks.
* Patients must have a Zubrod performance status of 0-2.
* Patients must sign an informed consent.
* Patients should have adequate bone marrow function defined by an absolute peripheral granulocyte count of \> 1,000 or cells/mm3 and platelet count \>50,000/mm3 and absence of a regular red blood cell or platelet transfusion requirement.
* Patients should have adequate hepatic function with a total bilirubin \< 2 mg/dl and SGOT or SGPT \< two times the upper limit of normal, and adequate renal function as defined by a serum creatinine \< 2.0 x upper limit of normal.
* Patients must have received at least two previous chemotherapy regimens for their disease.
* Patients must have measurable disease (NHL) or evaluable disease (MM, CLL).

Exclusion Criteria:

* Patients with symptomatic brain metastases are excluded from this study.
* Pregnant women or nursing mothers are not eligible for this trial. Patients of child bearing potential must use adequate contraception.
* Patients may receive no other concurrent chemotherapy or radiation therapy during this trial.
* Patients with severe medical problems such as uncontrolled diabetes mellitus or cardiovascular disease or active infections are not eligible for this trial.
Misoprostol With Mechanical Dilation Versus Oxytocin With Mechanical Dilation for High-risk Pregnancy Inductions

The purpose of this study is to specifically investigate whether oxytocin and mechanical dilation decreases the rate of cesarean section compared to misoprostol and mechanical dilation for pregnancies at risk of fetal compromise

This is a single center randomized control trial of two arms. Singleton, cephalic, high risk pregnancies will be randomized to either oxytocin with mechanical dilation versus misoprostol with mechanical dilation.

In group A, receiving misoprostol with mechanical dilation, will serve as the control group. Group B, oxytocin with mechanical dilation, will serve as the experimental group. The expected duration of participation begins at induction of labor and concludes at time of delivery.

Eligibility Criteria:
Inclusion Criteria:

* • Age \> 18 years old

  * Singleton, or twins with demise of one
  * Cephalic presentation
  * Intact membranes
  * Hypertension (chronic hypertension, gestational hypertension, pre-eclampsia with/without severe features, superimposed preeclampsia with/without severe features, eclampsia, HELLP)
  * Oligohydramnios (AFI\< 5cm and/or MVP \<2cm)
  * Fetal growth restriction (EFW or AC \<10th percentile) with normal or abnormal (elevated, absent, or reversed) Umbilical Artery Dopplers
  * Abnormal antenatal fetal testing (NST, Biophysical profile, decreased fetal movement) prompting induction of labor
  * Suspected placental abruption
  * Poorly controlled pre-gestational diabetes, defined as \>50% abnormal glucose values requiring increasing doses of anti-glycemic agents \>34 weeks, or requiring delivery
  * Gestational Age \> 22 weeks
  * Bishop score \< 6

Exclusion Criteria:

* • Prior cesarean delivery

  * Allergy to misoprostol
  * Allergy to oxytocin
  * Allergy to silicone/latex
  * Contraindication to vaginal delivery including placenta or vasa previa, Placenta accreta/increta/percreta, prior uterine rupture, Prior myomectomy entering the uterine cavity and necessitating cesarean delivery, active genital herpes, transverse or oblique fetal lie, umbilical cord prolapse, or HIV viral load \>1000 copies/mL
The Effect of Peri-implant Surgery and Chair-side Supportive Post Surgical Peri-implant Therapy

Peri-implantitis is defined as inflammation in the mucosa surrounding an oral implant with loss of supporting bone. The goals of peri-implantitis treatment are to resolve inflammation and to arrest the progression of disease. It is important to systematically gather information on the effect of surgical peri-implant treatment and to assess different protocols regarding chair-side maintenance of peri-implant tissue after surgery

The aims of this clinical investigation are to evaluate the clinical, microbiological and radiographic outcomes of surgical treatment of peri-implantitis and to evaluate the efficacy of 2 supportive treatment protocols based on the use of titanium cyrettes or by the use of a flexible, biodegradable chitosan brush. Furthermore, to evaluate the impact of this therapy on selected biochemical markers associated with chronic inflammation and bone tissue destruction.

Little is known about the effect of chair-side maintenance of dental implants after peri-implantitits surgery. Traditionally, the maintenance has been performed by titanium curettes to remove microbiological deposits from the submucosal area.

The Labrida biodegradable brush is a novel debridement device intended for use on dental implants. The concept of using a biodegradable material is related to the suggested problems with leaving remnants on the treated implant surface which would be negative from a bone regenerative aspect. The use of a flexible brush relates to the access problems when treating dental implants both related to the threads as well as due to the prosthetic supra construction hindering access for debridement with regular instruments developed for teeth. The material used in the brush will be Chitosan which is a natural polysaccharide, chitosan (poly-N-acetyl glucosaminoglycan), which is a nontoxic and bioabsorbable (REK-approval 2012/791 polymer).

H0: It is possible to maintain peri-implant health after surgical peri-implantitis treatment. There is no short- or long term clinical or radiographical differences between patients surgically treated for peri-implantitis maintained by the use of titanium cyrettes or with the Labrida brush in chair-side supportive care

Eligibility Criteria:
Inclusion Criteria:

Overt peri-implantitis presenting at least one implant with;

* radiographic bone loss ≥ 2.0 mm
* bleeding on probing (BoP)

Main exclusion criteria:

* radiotherapy
* chemotherapy
* systemic long-term corticosteroid treatment
* pregnancy or nursing
* anatomical abnormalities
* history of previous treatment of peri-implantitis within 6 months after the screening
* American Society of Anesthesiologists (ASA) classification for assessing the fitness of patients before surgery \> 2
Kidpower Camp - Structured Games or Playgroup

Clinically significant anxiety affects 20% of preschoolers and can become chronic, leading to depression, substance abuse, school-drop out and even suicide. To reduce anxiety and prevent its sequelae, clinically affected children must be effectively treated early. Available interventions for clinically anxious preschoolers are effective for some, but not all children, with as many as 50% of 4-7 year olds continuing to meet criteria for an anxiety disorder after treatment.

This trial aims to help learn how Camp Kidpower, trainings using either structured games or a playgroup, may lower anxiety in preschool age children. Playing these games and learning that kids can do it, can teach kids how to keep going when they are feeling anxious. To find out if Kidpower works by helping kids stay in charge of their behaviors and emotions, the study will look at parts of the brain as well as behaviors related to effortful control and fear, before and after training.

The study hypothesizes that Kidpower will produce greater increases in Error-related negativity (ERN), Interchannel Phase Synchrony (ICPS) and effortful control (EC) behaviors than in the Playgroup control.


Eligibility Criteria:
Inclusion Criteria:

1. Children between ages 4 -5.99 years at time of consent
2. Children that have a primary clinical diagnosis of separation anxiety disorder, social anxiety disorder, generalized anxiety disorder, panic disorder, and/or obsessive-compulsive disorder
3. Written informed consent by a parent/legal guardian and verbal assent from participant
4. Fluent in English

Exclusion Criteria:

1. History of head injury
2. History of serious medical or neurological illness
3. History of post-traumatic stress disorder (PTSD)
4. History of major depressive disorder (MDD)
5. Current psychotherapy or behavioral interventions
6. History of Neurodevelopmental delay, autism spectrum disorder (ASD), or intellectual disability
7. Currently taking medications that affect central nervous system functioning
8. Primary clinical diagnosis is selective mutism or specific phobia
9. Recent history of physically aggressive behaviors that have caused harm to other children
10. Sibling of a child who has participated or is currently participating in this protocol