cyrilzakka/clinical-trials huggingface dataset:
Investigator Initiated, Prospective Study of Xenia Corneal Lenticule

Cornea ectatic conditions such as keratoconus and post-LASIK (Laser In situ Keratomileusis) ectasia are disorders of the eye that are notorious for its uncontrolled progression over time, leading to loss of vision. There are valuable treatment options for controlling disease progression in mild to moderate stages of such disease. However in advanced cases and / or when contact lenses cannot be worn, surgery remains the only treatment option to rehabilitate vision. Most treatment options are highly invasive and represent significant risks. This study evaluates a novel corneal implant, Gebauer™ Lenticule to treat severe keratoconus or post-LASIK ectasia. This implant is derived from porcine collagen and intended for intra-stromal insertion. The Gebauer™ Lenticule is expected to improve the stability of the cornea while not impairing the vision. The procedure is an additive procedure after other treatment options have been exhausted. The procedure is reversible with removal of the implant (in the unexpected case of an adverse reaction), and vision may be restored to baseline.

The purpose of this study is to evaluate how well the implant is tolerated, it's safety profile, and how effective this new treatment option is in the treatment of keratoconus or post-LASIK ectasia.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of severe keratoconus in patients who would prefer to avoid corneal transplant surgery / penetrating keratoplasty OR
* Diagnosis of severe post-LASIK Ectasia in patients who would prefer to avoid corneal transplant surgery / penetrating keratoplasty
* In terms of general health, patients must be free of diagnosed terminal illnesses (life expectancy of greater than or equal to 2 years).
* Patients must be aged 18 years or over and less than 80 years old
* Patients' contact lenses must have been removed at least one-week prior to surgery for soft lenses and two weeks prior to surgery for hard lenses
* Subject understands the study requirements and the treatment procedures and provides written Informed Consent before any study-specific tests or procedures are performed
* Patient must be able and willing to complete all study visits and comply with the study-specific requirements

Exclusion Criteria:

* History or presence of any ocular pathologies that may interfere with the planned surgical treatment, including corneal epithelial problems
* Previous corneal transplantation or corneal implant in the designated eye
* Cataract with anticipated surgical intervention (IOL implantation) within 2 years
* Active inflammation and/or infection of the eye or the eye lid
* Patients with Intra Ocular Pressure (IOP) \<10 mmHg or \>21 mmHg
* Professionally diagnosed and currently treated autoimmune diseases
* Current strong symptoms of any allergy
* History of major organ transplantation and/or current continuing immunosuppressive treatment
* History of blood transfusion within the last 12 months
* Subject who is currently participating or has participated in another investigational clinical study within the past 60 days Pregnancy and lactation
Copeptin in Outcome Prediction of an Acute Psychotic Episode

An acute psychotic episode is a severe psychiatric syndrome which might occur in different psychiatric diagnoses.

The outcome prediction of relapse rate of a psychotic episode within a certain time frame is difficult and depends on many factors. More and better predictors are required to improve the outcome prediction in order to adjust therapy and follow-up if patients suffer from this acute disease.

Copeptin, a surrogate marker for vasopressin, has been proven helpful in the prediction of the outcome in serious somatic diseases. Additionally, a rise of copeptin due to psychological stress was shown.

The aim of this study is to investigate the association of the neuroendocrine biomarker copeptin and the prediction of the onset of psychotic episode within one year.

An acute psychotic episode is a severe psychiatric syndrome characterised by symptoms like delusions, hallucinations, and perceptual disturbances. A psychotic episode might occur in different psychiatric diagnoses, such as schizophrenia spectrum disorders and affective disorders (depression and bipolar).

The outcome prediction of relapse rate of a psychotic episode within a certain time frame is difficult and depends on many factors. More and better predictors are required to improve the outcome prediction in order to adjust therapy and follow-up if patients suffer from this acute disease.

Copeptin, a surrogate marker for vasopressin, has been proven helpful in the prediction of the outcome in serious somatic diseases such as stroke, myocardial infarction, and pneumonia. Additionally, a rise of copeptin due to psychological stress was shown.

Some studies have shown an increase in vasopressin levels during acute psychosis, no study has been performed using copeptin.

The aim of this study is to investigate the association of the neuroendocrine biomarker copeptin and the prediction of the onset of psychotic episode within one year.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-55 years
* Acute psychotic episode
* Informed consent as documented by signature

Exclusion Criteria:

* Limited discernment due to psychiatric disorder to give informed consent
* Acute psychotic Episode due to any organic reason
* Psychotic Episode due to psychotropic substances
* Severe somatic disease (acute myocardial infarction, acute sepsis, acute stroke)
Bariatric Education for Women With Obesity and Endometrial Cancer

The purpose of this study is to examine whether a standardized video education tool will improve knowledge regarding obesity and bariatric surgery and increase bariatric surgery referrals for obese women with endometrial cancer.

An estimated 50% of all endometrial cancer cases are associated with obesity. Bariatric surgery has been shown to reduce the risk of hormone-related cancers, including endometrial cancer, by up to 70-80%. This prospective, study of 80 patients will be randomized to either a standard education for weight loss provided by their oncologist or a standard education plus a 15-minute video with information regarding obesity, relationship of obesity and endometrial cancer, and the safety and benefits of bariatric surgery.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18-80 with class II or greater obesity (BMI ≥ 35)
* Have pathologically-confirmed endometrial cancer
* Have completed initial therapy (e.g. surgery, hormonal therapy, vaginal cuff brachytherapy, or a combination of these modalities) and require no further interventions related to cancer care. Patients taking hormonal therapy as part of cancer treatment may be included.

Exclusion Criteria:

* Under the age of 18 or over the age of 80
* Have previously undergone bariatric surgery
* Requires ongoing cancer treatment with chemotherapy or whole pelvic radiation.
* Poor surgical candidate secondary to comorbidities or performance status.
Benzocaine Gel Toothache Dose-Response Study

To evaluate the efficacy and safety of benzocaine gel products for the relief of toothache and to assess the subject's compliance with proposed label directions.


Eligibility Criteria:
Inclusion Criteria:

* Males or females at least 12 years of age.
* Presence of spontaneous toothache pain in only one permanent tooth. Toothache pain is due only to an open tooth cavity and only as a result of dental caries, loss of a restoration or tooth fracture.
* To qualify for the study, the subject must have a rating of at least moderate pain on the Dental Pain Scale (DPS) and a score of at least 50 mm on the Visual Analog Scale. To be included in the moderate pain stratum, the subjects must have a rating of moderate pain in the DPS and to be included in the severe pain stratum the subjects must have a rating of severe pain in the DPS.
* Females who are neither pregnant, as verified by a urine-based pregnancy test, nor breast-feeding.
* Female subjects of childbearing potential and those who are post-menopausal for less than 2 years must be using a medically approved method of contraception (i.e., oral, transdermal or implanted contraceptive devices, intrauterine device, diaphragm, condom, abstinence, or surgical sterility).
* Subjects must be reliable, cooperative and of adequate intelligence to read and understand the rating scales and other study instructions.
* Subjects must be able to read, comprehend, and sign the consent form. Minors will provide assent to study participation if age appropriate. Parent/legal guardian must be able to read, comprehend, and sign the informed consent form.

Exclusion Criteria:

* Presence of spontaneous toothache pain in a primary tooth. Presence of spontaneous toothache pain in more than one tooth. Presence of an open tooth cavity in a tooth adjacent to the painful tooth with the open tooth cavity.
* Presence of concomitant oral pain due to any other condition such as: soft-tissue lesions (e.g., aphthous or traumatic ulcer, herpes labialis, acute necrotizing ulcerative gingivitis); or multiple hard-tissue (e.g., carious) lesions; pain due to other surgical procedures, injuries or dental surface sensitivity.
* Presence of a periodontal abscess as diagnosed from an X-ray or clinical examination of the painful tooth.
* Presence of glucose-6-phosphate dehydrogenase (G6PD) deficiency.
* History of acute or chronic hemolytic anemia.
* History of sensitivity or allergy to benzocaine or other local anesthetic agents.
* Use of any short-acting oral or topical analgesic/ anesthetic product within 2 hours of enrollment or any long-acting Rx or OTC analgesic product within 4 hours of enrollment.
* Use of an investigational drug or participation in an investigational study within the past 30 days.
* Previous participation in this study.
* Member or a relative of the study site staff or sponsor directly involved in the study.
Thorax Enlarging Surgery: a Novel Surgical Approach to Emphysema

There is a growing population of end-stage COPD patients for whom surgical treatments like lung transplantation and lung volume reduction surgery are not possible. In such patients, size mismatch between large emphysematous lungs and a restricted chest wall is a major cause for the reduction of dynamic lung volumes and consequent dyspnea. We hypothesized that enlargement of the thorax would be a potential alternative strategy to volume reduction surgery as it may improve lung mechanics by resizing the chest to the lung and does not further deprive patients from lung tissue which is already scarce.

Lung volume reduction surgery primarily increases vital capacity by reducing RV more than TLC. As the chest wall is the major TLC limiting factor, an alternative approach that could circumvent size mismatch would be a surgical enlargement of the thorax cavity. Any post-operative increase of TLC would allow greater dynamic operational lung volumes to occur with an equal amount of dead space. Moreover, resizing of the thorax would have a tremendous advantage over resizing of the lung, in that it would not require resection of the lung in patients in whom lung tissue is already scarce. Chest expansion will only be guaranteed if the sternal widening osteotomy will obtain a solid union. Small poly-ether-ether-keton (PEEK) cages were designed to match both sternal halves in a 'press fit' way, which were filled with lyophilised bone and fixed with extra wires as in a classical sternotomy. These bone-filled cages function as a perfect matrix for progressive in-growth of cancellous bone.

Eligibility Criteria:
Inclusion Criteria:

patients with end-stage emphysema and

* Disabling dyspnea
* GOLD III or IV
* Residual volume \> 200% predicted
* Total Lung capacity \> 120% predicted
* RV/TLC \> 0.6
* Resting CO2 \< 50 mmHg
* diffusion capacity \> 20% predicted
* age \< 70 years

Exclusion Criteria:

* previous sternotomy
* contraindication of general anesthesia
* chronic treatment with corticosteroids
* any tobacco use within 6 months
* candidates for lung volume reduction surgery or lung transplantation
Reducing Sugar-sweetened Beverage Consumption in Overweight Adolescents

The primary aim of this study is to examine the effect of a multi-component intervention, designed to reduce consumption of sugar-sweetened beverages, on weight gain, total energy intake, and diet quality in adolescents. The secondary aim is to evaluate whether outcomes of the intervention differ between adolescents for whom 100% fruit juice vs. other products (i.e., soda, fruit punch, lemonade, iced tea, coffee drinks, energy drinks, sports drinks) constitutes the primary source of sugar from beverages.

We are partnering with community organizations (including high schools) in the greater Boston area and a major regional supermarket. Participants will be 240 high school students who drink at least 1 serving of sugar-sweetened beverage (including 100% fruit juices) per day and who have a BMI ≥ 85th percentile. They will be randomly assigned to an intervention or control group. The intervention, of 1-year duration, will target the home/family environment in combination with a behavioral intervention provided during brief check-in visits. The environment will be changed by delivering non-caloric beverages to the homes of adolescents who regularly consume sugar-sweetened beverages. Parents will be counseled by telephone to serve as role models in consuming non-caloric beverages. The behavioral intervention for the adolescents will include didactic and experiential components during the check-in visits. Study outcomes will be assessed at baseline, 1 year (end of intervention period), and 2 years (end of follow-up period).

Additional relevant material based on the original proposal (NIH grant application) is provided below:

Each outcome will be compared between groups using a general linear model, adjusted for baseline covariates that could affect body weight: sex, race, ethnicity (Hispanic vs non-Hispanic), household income, parents' education, BMI, beverage consumption (sugar-sweetened, artificially sweetened, unsweetened), energy intake (total, sugar-sweetened beverages, fruit juice), physical activity level, and daily television viewing. Each covariate will be tested for confounding, mediation, and interaction effects on the primary outcome. Stratum-specific estimates of the group difference will be constructed for any covariates showing significant interaction.

Eligibility Criteria:
Inclusion Criteria:

* Enrolled in grade 9 or 10
* BMI ≥ 85th percentile for age and gender
* Residing in predominately one household, with access to a working telephone
* Consumption of 12 fluid ounces sugar-sweetened beverages (including 100% fruit juices) per day

Exclusion Criteria:

* Sibling participating in the study
* Intention to change location of residence during the 2 years post-randomization
* Plans to be away from home for 5 weeks or longer during the study period
* Physician diagnosis of a major medical illness or eating disorder
* Chronic use of any medication that may affect body weight or composition
* Current smoking
* Physical, mental, or cognitive handicaps that prevent participation
Effect of Grape Juice Consumption on the Parameters of Oxidative Stress and Muscle Fatigue in Judo Athletes

This project aims to evaluate if after 14 days of grape juice ingestion there is improvement of the parameters of strength, fatigue and oxidative stress in judo fighters. The study will be a randomized, blind, crossover clinical trial of 20 Judo athletes. Judo wrestling simulations will be performed on 3 different days.

Grape juice has a high concentration of phenolic compounds and is capable of modulating biochemical parameters and oxidative stress. By naturally containing carbohydrates grape juice can help acutely minimize fatigue during exercise as well as long-term oxidative stress parameters in athletes. This project aims to evaluate if after 14 days of grape juice ingestion there is improvement of the parameters of strength, fatigue and oxidative stress in judo fighters. The study will be a randomized, blind, crossover clinical trial of 20 Judo athletes. Judo wrestling simulations will be performed on 3 different days. Each exercise session will consist of four 7-minute bouts, with 14-minute rest between them. The athletes will perform a first fight simulation without ingestion of any beverage (control group 1), and then will be randomized to determine the order of participation in the groups: maltodextrin (group 2 placebo) and grape juice (intervention group 3). Analyzes of oxidative stress; Muscle strength and fatigue; Perceived effort rate; Lactate; Heart rate; Analysis of food consumption and body composition.Two-way ANOVA will be used to evaluate the relation of the intervention and physical exercise, besides parameters of strength and fatigue. The level of significance adopted will be 5% and for the analysis, the SPSS summer 23 statistical program will be used.

Eligibility Criteria:
Inclusion Criteria:

* Judo athletes, federated, who hold state, federal and international competitions of both sexes, aged between 15 and 24 years and any weight category of the sport, except free weight.

Exclusion Criteria:

* Recent injury (last 3 months) that prevents training or competition;
* Food restriction on grape juice;
* Being in the phase of fast weight loss in pre competition..
Medical Cannabis for Treating Pain Related to Fibromyalgia

The goal of this interventional study is to learn about the effect of Medicinal Cannabis (Bedrocan®) on Fibromyalgia patients with pain resistant to conventional therapy. The main question the trial aims to answer are:

* Is Bedrocan® effective for treating fibromyalgia-related pain in patients resistant to conventional therapy?
* Can a low dosage of medical cannabis taken as a decoction reduce fibromyalgic pain?

All patients were trained on how to make the decoction: therapy was started with 100 mg/day (1 folder) and increased to 200 mg/day (2 folders) in non-responders.

The study took place in the pain therapy unit of San Carlo Hospital (Potenza, Italy) between March 2021 and September 2021. Over this period, 44 subjects visited the pain unit and underwent specialist evaluation. Fibromyalgia syndrome was confirmed using the Widespread Pain Index (WPI) and Symptom Severity (SS) scale criteria, resulting in the recruitment of 34 subjects. Two participants discontinued therapy due to side effects, while 2 other patients were excluded for not initiating treatment within the required timeframe. Therefore, the final number of recruited fibromyalgic subjects for the study was 30. Among these subjects, those who provided informed written consent for starting the trial with medical cannabis were prescribed Bedrocan® once a month, with a total of 30 prescriptions per month for a duration of 6 months.

All patients were instructed on how to prepare the decoction; the therapy was started with 100 mg/day (1 chart) and increased to 200 mg/day (2 charts) in non-responsive subjects.

The Numerical Rating Scale (NRS) and SF-12 Short Form health questionnaire were used to evaluate pain intensity and the quality of life at the beginning of the study and 6th-month follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Informed written consent;
* Age \>18 years old;
* Diagnosis of FM confirmed by a rheumatologist;
* Persistent pain symptoms for at least three months without complaints that may otherwise explain the pain condition;
* Persistent pain syndrome on conventional therapy with opioids or non-steroidal anti- inflammatory drugs
* Not having taken medical cannabis in the previous year since the start of the study
* Stopping drug therapy during the trial with cannabis (Bedrocan®).

Exclusion Criteria:

* Specific contraindications to cannabinoid use;
* Pain syndrome not associated with FM
* Major comorbidities like renal impairment, severe liver disease, chronic hepatitis C, history of alcohol or drug addiction
* The presence of cognitive deficits that could impair understanding of the study, completion of questionnaires, or adherence to therapy.
* Pregnant or planning pregnancy women and breastfeeding women
Evaluating the Efficacy and Safety of Bromhexine Hydrochloride Tablets Combined With Standard Treatment/ Standard Treatment in Patients With Suspected and Mild Novel Coronavirus Pneumonia (COVID-19)

Compare the efficacy and safety of Bromhexine Hydrochloride Tablets combined with standard treatment/ standard treatment in patients with suspected and mild, or common novel coronavirus pneumonia (COVID-19).

Random, open, group sequential design.


Eligibility Criteria:
Inclusion Criteria:

* Aged between 18 and 80 years (Including 18and 80years, male or female).
* One of them:

  1. Laboratory (RT-PCR) and clinical symptoms confirmed case of novel coronavirus pneumonia (COVID-19).
  2. Patients diagnosed clinically as suspected cases.
* Ability to communicate well with researchers and sign the informed consent Form (ICF) voluntarily.

Exclusion Criteria:

* ALT≥5 times of ULN, level of total bilirubin≥3 times of ULN, or Cr≥1.5 times of ULN.
* Patients with serious severe liver disease.
* Excluded who diagnosed as pneumonia patients with novel coronavirus infection of severe type and critical type. 【Diagnostic criteria reference the official guideline "Pneumonia Diagnosis and Treatment Scheme for Novel Coronavirus Infection (Trial Version 5) "】.
* Patients with previous history of severe gastrointestinal diseases such as gastric ulcers and bleeding.
* Patients with lactose intolerance.
* Patients who are allergic to the components of this medicine (Major components: Bromhexine Hydrochloride; excipient: starch, lactose, magnesium stearate).
* Positive serum pregnancy test result for women with childbearing potential at screening or lactating women.
* Other circumstances that the researcher considers inappropriate to participate in this study.
Reinforcement of Rectal Anastomosis-RORA

The anastomotic leaks are multivariable in its origin. The incidence varies among different centers between 4% and as high as 25%. The impact of leakage in a rectal anastomosis can be devastating for the patient and very costly for the health care system.

Prolonged hospital stay (LOS), invasive treatment and intensive care are the consequences.

The future of colorectal surgery will increasingly include older patients with increased preoperative morbidity and probably even higher risk for anastomotic leaks. which makes it suitable for reinforcing a rectal anastomosis. The goal is to shift the clinical leaks spectrum into a subclinical and therefore self-healing one.

The rationale is to explore if the procedure of reinforcement with HemoPatch and bringing more mechanical strength over an extended area around the anastomosis thus lowers the incidence of clinical anastomotic leaks.

The characteristics of HemoPatch, with its structural properties such as flexibility and tissue adhesion are suitable for this purpose.

Eligibility Criteria:
Inclusion Criteria:

* Rectal surgery with anastomosis below 10 cm from anal verge

Exclusion Criteria:

* none