cyrilzakka/clinical-trials huggingface dataset:
Retinal Microvasculature Before and After Silicone Oil by OCTA

Prospective study to assess the retinal microvasculature, optic nerve head vasculature and retinal sensitivity using OCTA and microperimetry before and after silicone oil removal.

Prospective study to assess the retinal microvasculature, optic nerve head vasculature and retinal sensitivity using OCTA and microperimetry before and after silicone oil removal.

The study includes 30 patients with silicone oil tamponade will be evaluated before and after silicone oil removal

Eligibility Criteria:
Inclusion Criteria:

* 30 eyes of 30 patients with silicone oil tamponade will be evaluated before and after silicone oil removal

Exclusion Criteria:

* Proliferative diabetic retinopathy, recurrent detachment or macular hole
* Patients with chorioretinal degenerations involving the macula
* Secondary complications as cataract, silicone oil emulsification, or secondary glaucoma
* Media opacity hindering proper imaging
Measuring Intraabdominal Pressure, Lactic Acid, and Urine Output

This study serves as a pilot study with the intention to to measure intraabdominal pressure, lactic acid, and urine output in obese individuals undergoing laparoscopic inguinal hernia repair. By measuring these values, the investigators aim to look for correlations between metrics and determine an accurate and precise measurement of IAP during laparoscopic hernia surgery using the Accuryn Monitoring System. By obtaining accurate and precise measurements of IAP during surgery the investigators will be to compare measurements to previous IAP data obtained during daily activities and strenuous movements and any associations with inguinal hernia recurrence.


Eligibility Criteria:
Inclusion Criteria:

* Obese with BMI \> 30
* Diagnosis of inguinal hernia
* Qualify for laparoscopic inguinal hernia repair

Exclusion Criteria:

* Previous bowel resections resulting in short bowel
* Extensive abdominal scarring
* BMI \< 30
* Fail to qualify for laparoscopic inguinal hernia repair
Phase I/II Study With Oral Panobinostat Maintenance Therapy Following Allogeneic Stem Cell Transplantation in Patients With High Risk Myelodysplastic Syndrome (MDS) or Acute Myeloid Leukemia (AML)

The study's primary objective is to determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of Panobinostat when administered within 150 days after hematopoietic stem cell transplantation (HSCT) and given in conjunction with standard immunosuppressive therapy after HSCT for patients with high-risk Myelodysplastic Syndrome (MDS) or Acute Myeloid Leukemia (AML).

Secondary objectives are

* To determine safety and tolerability of panobinostat
* To determine overall and disease-free survival at 12 months after HSCT
* To evaluate immunoregulatory properties of panobinostat
* To evaluate patient-reported health-related quality of life (HRQL)

The hypothesis of this study is that panobinostat can be an effective drug in preventing relapse of MDS and AML patients with high-risk features after hematopoietic stem cell transplantation with reduced-intensity conditioning (RIC-HSCT) while at the same time reducing graft-versus-host disease (GvHD) with preservation of graft-versus-leukemia (GvL) effect.


Eligibility Criteria:
Inclusion Criteria:

* AML (except acute promyelocytic leukemia, AML M3) with high-risk features defined as one or more of the following criteria:

  * refractory to or relapsed after at least one cycle of standard chemotherapy
  * \> 10% bone marrow blasts at day 15 of the first induction cycle
  * adverse risk cytogenetics including complex karyotype (≥ 3 abnormalities or abnormalities of chromosomes 3, 5 or 7) regardless of stage
  * secondary to MDS or radio-/chemotherapy or
* MDS RAEB according to the WHO classification or intermediate-2 or high-risk according to IPSS or
* Chronic myelomonocytic leukemia (CMML) with ≥ 5% bone marrow blasts and

  * Allogeneic HSCT with reduced intensity conditioning (see Section 15.1 for definition) performed within 60 - 150 days prior to study entry
  * Complete hematologic remission documented by bone marrow aspiration within 28 days prior to study entry

Exclusion Criteria:

* Active acute GvHD overall grade 2 - 4
* Prior treatment with a deacetylase (DAC) inhibitor
* Patients with impaired cardiac function or other concurrent severe and/or uncontrolled medical conditions
* Clinical symptoms suggesting central nervous system (CNS) leukemia
* Patient has an impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral panobinostat
LEO 32731 for the Treatment of Moderate to Severe Psoriasis Vulgaris

A study of LEO 32731 in the treatment of psoriasis vulgaris

This is an investigation of the efficacy of LEO 32731 30 mg as compared to placebo after 16 weeks of oral treatment of psoriasis vulgaris

Eligibility Criteria:
Inclusion Criteria:

* Signed and dated informed consent
* Aged between 18 years and 65.
* Males or females of non-childbearing potential.
* Clinical diagnosis of psoriasis vulgaris with or without psoriatic arthritis
* Have moderate to severe psoriasis vulgaris
* Candidates of systemic anti-psoriatic treatment and/or phototherapy

Exclusion Criteria:

* Subjects with therapy resistant psoriasis
* Previously exposed to apremilast
* Systemic treatment with biological therapies, whether marketed or not, with a possible effect on psoriasis vulgaris
* Systemic treatment with all other therapies (other than biologics) with a possible effect on psoriasis vulgaris
A Study of the Efficacy and Safety of Orvepitant in Subjects With Pruritus Associated With Atopic Dermatitis

The purpose of this study is to determine the effectiveness of three doses of orvepitant, taken once a day, in the treatment of pruritus associated with atopic dermatitis.

A multi-center, double-blind, randomized, parallel group, placebo-controlled dose range study in subjects with pruritus associated with atopic dermatitis.

Doses of orvepitant (10 mg/day, 20 mg/day and 30 mg/day) and placebo will be investigated in four parallel groups.

Each group will compromise of approximately 100 subjects, randomized 1:1:1:1 (approximately 400 subjects in total).

All subjects will enter a two-week screening period to determine eligibility. Eligible subjects will be randomized at the Baseline/Day 1 visit and enter a 12-week double-blind dosing period. During this period there will be four visits at Weeks 2, 4, 8 and 12. There will be a final safety follow-up visit four weeks after the end of the treatment period.

Eligibility Criteria:
Key Inclusion Criteria:

* Documented diagnosis of Atopic Dermatitis for ≥ 6 months confirmed by either the UK Working Party definition or the Hanifin definition
* Subjects must have chronic (\> 6 months) pruritus which is unresponsive or inadequately responsive to current therapies such as topical steroids or antihistamines
* Subjects must have atopic dermatitis with a severity \> 3 on the IGA and EASI ≥12 at Screening visit/Visit 1

Key Exclusion Criteria:

* Presence of, or history of, any other inflammatory dermatosis or skin conditions which may cause pruritus
* Any other possible cause for pruritus eg systemic, neurological, idiopathic, or metabolic
* Acute super-infection of AD lesions requiring treatment with antibiotics within 4 weeks of Visit 2
* Inability to comply with the use of prohibited and allowed medications as described in the protocol.
The Effectiveness of Diabetic Foot Wound Prevention Training

This study aimed to evaluate the impact of diabetic foot care training delivered using the Pecha Kucha (20\*20) presentation method on the knowledge, self-efficacy, and behavior levels of patients with Type 2 diabetes. Conducted between December 10, 2023, and October 7, 2024, this randomized controlled experimental study included 125 diabetic individuals, with 62 in the experimental group and 63 in the control group. The experimental group received diabetic foot care education using the Pecha Kucha method, while the control group received conventional education. Data were collected using the Patient Assessment Form, Diabetes Foot Knowledge Questionnaire, Diabetic Foot Care Self-Efficacy Scale, and Foot Self-Care Behavior Scale.

This study aimed to evaluate the impact of diabetic foot care training delivered using the Pecha Kucha (20\*20) presentation method on the knowledge, self-efficacy, and behavior levels of patients with Type 2 diabetes. Conducted between December 10, 2023, and October 7, 2024, this randomized controlled experimental study included 125 diabetic individuals, with 62 in the experimental group and 63 in the control group. The experimental group received diabetic foot care education using the Pecha Kucha method, while the control group received conventional education. Data were collected using the Patient Assessment Form, Diabetes Foot Knowledge Questionnaire, Diabetic Foot Care Self-Efficacy Scale, and Foot Self-Care Behavior Scale.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of type 2 diabetes according to the American Diabetes Association (ADA) criteria at least six months before the study
* age 18 years or older, literacy in and ability to speak Turkish,
* absence of communication/mental problems,
* willingness to participate in the study.

Exclusion Criteria:

* presence of advanced retinopathy, violation of inclusion criteria, withdrawal of consent by the patient.
A Study of LX211 in Clinically Quiescent Non-infectious Intermediate, Anterior and Intermediate, Posterior or Pan-Uveitis

The objective of this study is to evaluate the safety and efficacy of LX211 as therapy in subjects with clinically quiescent non-infectious uveitis


Eligibility Criteria:
Inclusion Criteria:

* A documented history of non-infectious intermediate, anterior and intermediate, posterior or panuveitis.
* Minimum prescribed therapy upon enrollment is one or more of the following:

  * systemic prednisone or equivalent averaging ≥ 10 mg/day
  * at least 2 periocular/intravitreal corticosteroid administrations for control of inflammatory disease within the previous 8 months (but not within 6 weeks of randomization).
  * at least one, but not more than 2 immunosuppressive drugs from among the following compounds: cyclosporine, tacrolimus, azathioprine, mycophenolate mofetil, methotrexate
* Subjects with clinically quiescent uveitis in both eyes at enrollment and who have been on a stable treatment regimen for a minimum of 6 weeks
* Best-corrected distance visual acuity in the worst involved eye of 20/400 or better (ETDRS logMAR \<1.34)
* Subjects not planning to undergo elective ocular surgery during the study

Exclusion Criteria:

* Evidence of active, uncontrolled non-infectious uveitis
* Periocular administration of corticosteroids within the previous 6 weeks.
* Uveitis of infectious etiology
* Uncontrolled glaucoma
* Clinically suspected or confirmed central nervous system or ocular lymphoma
* History or diagnosis of Behçet's disease
* Primary diagnosis of anterior uveitis
ENVASARC: Envafolimab And Envafolimab With Ipilimumab In Patients With Undifferentiated Pleomorphic Sarcoma Or Myxofibrosarcoma

This is a multicenter open-label, randomized, non-comparative, parallel cohort pivotal study of treatment with envafolimab (cohort A and C) or envafolimab combined with ipilimumab (cohort B and D) in patients with locally advanced, unresectable or metastatic undifferentiated pleomorphic sarcoma (UPS)/myxofibrosarcoma (MFS) who have progressed on one or two lines of chemotherapy.

This is a multicenter open-label, randomized, non-comparative, parallel cohort pivotal study of treatment with envafolimab (cohort A and C) or envafolimab combined with ipilimumab (cohort B and D) in patients with locally advanced, unresectable or metastatic UPS/MFS who have progressed on one or two lines of chemotherapy. Patients were previously assigned at random into one of two cohorts: cohort A of 80 patients who received single agent envafolimab (300 mg every 3 weeks by subcutaneous (SC) injection) or cohort B of 80 patients who received envafolimab (300 mg every 3 weeks by SC injection) in combination with ipilimumab (1 mg/kg every 3 weeks intravenously for four doses). Following amendment #3, patients will be assigned at random into one of two cohorts: cohort C of 80 patients who will receive single agent envafolimab (600 mg every 3 weeks by subcutaneous (SC) injection) or cohort D of 80 patients who will receive envafolimab 600 mg every 3 weeks by SC injection) in combination with ipilimumab (1 mg/kg every 3 weeks intravenously for four doses). Following amendment #4, enrollment into cohort D was terminated and no further interim analyses will be conducted on this cohort.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed locally advanced or metastatic undifferentiated pleomorphic sarcoma (UPS) or grade ≥ 2 myxofibrosarcoma (MFS)
* Documented progression following systemic chemotherapy
* At least one measurable lesion
* Eastern Cooperative Oncology Group performance status of 0 or 1
* Adequate hematologic and organ function

Exclusion Criteria:

* More than two prior lines of chemotherapy for UPS/MFS
* Prior immune checkpoint inhibitor or immunomodulatory therapy
* Active autoimmune disease that has required systemic treatment
* Major surgery within 4 weeks of dosing of investigational agent
* Active additional malignancy
* Pericardial effusion, pleural effusion, or ascites
* Central nervous system metastases and/or carcinomatous meningitis
* Active hepatitis or cirrhosis
* Interstitial lung disease
* Unwilling to apply highly effective contraception during the study
* Other concurrent severe and/or uncontrolled medical conditions that would, in the investigator's judgment, contraindicate patient participation in the clinical study
Evaluation of the Efficiency of Single Aligner Appliance for Treatment of Mild Crowding Cases in Adults.

36 participants who have mild crowding from the Orthodontic Department at University of Damascus Dental School will be randomly assigned into two groups.

1. In the experimental group, patients will be treated using single aligner appliance in order to align their crowding teeth.
2. Control group will undergo typical orthodontic treatment using an MBT-prescription of metallic brackets.

Most adult patients do not prefer traditional fixed appliances for aesthetic reasons, long treatment duration, and relatively difficult oral care. The current study came in order to evaluate the Efficiency of a new single aligner appliance that is both aesthetic and economical.

Eligibility Criteria:
Inclusion Criteria:

1. Adults patients aged between (16 - 28) years.
2. Class I malocclusion with Mild crowding (1 - 4) mm in the anterior region of the mandibular dental arch
3. All lower teeth are existed (except for third molars).
4. No congenitally missing or extracted teeth (except for third molars)
5. Patients have not undergone previous orthodontic treatment.
6. Patient with good oral hygiene (Plaque Index less than 1).
7. With no severe skeletal discrepancy.

Exclusion Criteria:

1. Bimaxillary dentoalveolar severe protrusion.
2. Any systemic diseases affect teeth movement.
3. Bad oral hygiene.
4. Patient lack of commitment toward follow-up appointments.
Effect of Whey Protein' Supplementation and Exercise in Patients With Heart Failure

The aim of this study is evaluate the effect of whey protein supplementation on muscle mass preservation, improvement of strength and quality of life, and inflammatory parameters in patients with heart failure NYHA I or II followed by a cardiac rehabilitation program.

Heart failure is the final route of most heart diseases and is a worldwide problem due to its high prevalence, morbidity and mortality. In Brazil, it is an important cause of hospitalization and one of the most important health challenges, since its prevalence tends to increase with the aging of the population and the increase in the survival of patients who have suffered acute coronary events. This is an ongoing epidemic problem, resulting in a high socioeconomic cost, represented by the expense of medications, repeated hospitalizations, loss of productivity, early retirements, possible surgeries and, ultimately, heart transplantation. In this sense, it is of great importance to carry out studies that evaluate the possible benefits of new clinical and nutritional interventions for HF patients, favoring the development of treatment strategies for these individuals and also for public health.

Our hypothesis is based on the fact that whey protein supplementation associated with physical exercise in patients with heart failure could promote preservation of muscle mass, increase in muscle strength, and improve quality of life, Body composition and physical capacity. The volunteers will receive 30 grams per day of whey protein or maltodextrin in a double-blind, controlled clinical trial lasting 12 weeks. During this period they will perform supervised physical exercise 3 times a week in a cardiac rehabilitation program. They will also receive nutritional counseling.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of heart failure NYHA I or II after medical evaluation;
* Indication to participate in a cardiac rehabilitation program;
* Fully medicated for heart disease;
* Age greater than or equal to 50 years;
* Ejection fraction less than 50%.

Exclusion Criteria:

* Neoplasia at any site;
* Impaired renal function (\<50ml / min / 1.73m2);
* Impaired hepatic function (TGP\> 150U / l) or decompensated hepatic cirrhosis classified with Child-Pugh B or C;
* Presence of ressincronizer or other device;
* Atrial fibrilation;
* Allergy of milk protein.
Effect of Gastric Bypass Surgery on Energy Metabolism

The purpose of this study is to investigate the short term and long term effects of Roux-en-Y gastric bypass (RYGB) surgery on energy expenditure, gastrointestinal and appetite regulating hormone levels, and appetite sensation. We hypothesize that following RYGB surgery, metabolism will be elevated in comparison to patients who have not yet had RYGB but who are losing weight simultaneously using a low calorie diet. We further hypothesize that this higher metabolism will be associated with alterations in fasting and postmeal levels of gastrointestinal and appetite regulating hormones. Long term (1.5 years after RYGB), we hypothesize that differences in metabolism, body composition, and hormone levels will distinguish between patients who have maintained their weight loss after RYGB vs those who have regained weight.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-65
* BMI ≥40, or ≥35 with concomitant obstructive sleep apnea, or hypertension
* scheduled for RYGB surgery at Hvidovre Hospital, Copenhagen, Denmark
* Must have lost between 1-4% body weight after 3 months of dietary counselling

Exclusion Criteria:

* Deemed ineligible for RYGB surgery by patient's own physician(s)
* Diabetes Mellitus
* Non Caucasian
* Weight \>160kg (due to DEXA scanner limitations), or morphologically unable to accommodate in DEXA scanner (\>40cm in maximum supine anterior-posterior dimension, or \>60cm in maximum supine body width)
* Hemoglobin \<7.0 mmol/L
* Psychiatric illness under the care of a psychiatrist
* Eating disorder such as bulimia
* Patients on special diets (eg vegetarian, Atkins)
* Any history of thyroid dysfunction, or use of thyroid medication (with the exception of transient thyroiditis)
* Hypothalamic or genetic etiology of obesity
* A current diagnosis of cancer
* Any surgery other than RYGB planned in the ensuing 3 months
* Substance abuse or smoking
* Use of prescription medications or over-the-counter drugs affecting metabolism
* Excessive intake of alcohol (\>7 drinks/week)
* Excessive intake of caffeine (\>300 mg/day)
* Presence of any contraindication to use of a low calorie powder diet, including:

  * Past history of ventricular arrhythmias (even if treated)
  * Renal dysfunction (creatinine clearance \<60 mL/min)
  * Liver enzymes (ALT or AST) \>3x upper limit of normal
  * Milk protein allergy, or lactose intolerance
  * Porphyria or phenylketonuria
  * History of gout
  * Breastfeeding
  * Concomitant use of monoamine oxidase inhibitors or non potassium sparing diuretics
  * Inability or unwillingness to comply with a low calorie diet protocol
  * Patients who find the powder diet products to be unpalatable
* Do not enjoy yogurt, carrots, or milk (as these are essential elements of the low calorie diet)
Pharmacokinetics of THCCOOH and Its Acyl-glucuronide After Intravenous Administration of THCCOOH

A study on the fate and elimination of 11-Nor-Delta9-carboxy-9-tetrahydrocannabinol was up to now not conducted, except of one single experiment in which (lacking) psychopharmacological activity was tested after intravenous infusion of 20 mg in a human individual. In this study, however, the authors did not trace the above questions due to analytical and methodological deficits.

Aim of the study is to determine the pharmacokinetics of THCCOOH and THCCOOH-Glu after intravenous ad-ministration of 5 mg THCCOOH in healthy individuals

To determine the pharmacokinetics of THCCOOH after intravenous administration of THCCOOH (5 mg) and its formed glucuronide in healthy individuals in order to improve the possibilities for the assessment of unfitness to drive. For these purposes the following criteria will be studied:

THCCOOH

* Primary: Area under the plasma concentration time curve (AUCtotal) Maximal plasma concentrations (Cmax) Time of Cmax (tmax) Terminal elimination half-life (t1/2)
* Secondary: Systemic and renal clearance (Cls, CLr) Volume of distribution of (Vc) Formed THCCOOH-glu
* Primary: Area under the plasma concentration time curve (AUCtotal) Maximal plasma concentrations (Cmax) Time of Cmax (tmax) Terminal elimination half-life (t1/2)
* Secondary: Systemic and renal clearance (Cls, CLr) Volume of distribution (Vc)

Eligibility Criteria:
Inclusion Criteria:

* Good state of health (physically and mentally)

Exclusion Criteria:

* Any regular drug treatment within the last two months
* Any intake of a substance known to induce or inhibit drug metabolising enzymes or transport systems within a period of less than 10 times the respective elimination half-life
* Any acute or chronic illness or clinically relevant findings in the pre-study examination
* Allergies (except for mild forms of hay fever) or history of hypersensitivity reactions
* Smoking (regular or irregular)
* Excessive alcohol drinking (more than approximately 30 g alcohol per day)
* Positive drug screening especially THC or known or admitted drug abuse