cyrilzakka/clinical-trials huggingface dataset:
IOP and Ocular Biometrics Changes After Phacoemulsification in Glaucoma Patients and Controls

Effect of phacoemulsification on intraocular pressure has been studied with variable results.Furthermore, effect of phacoemulsification on ocular biometrics including anterior chamber depth and angle opening distance has also been studied. In our study we aim at establishing a quantitative relationship between preoperative ocular biometrics and postoperative intraocular pressure change and comparing this relationship in glaucomatous and non-glaucomatous eyes.

All patients will have the anterior chamber angle assessed by indentation gonioscopy preoperatively. Anterior Chamber Depth \& lens thickness will be measured by Optical Biometry (lenstar 900) as well as measurement of the angle \& lens vault using the Ultrasound Biomicrosopy (UBM) before and 1 month after cataract surgery. IOP will be measured pre- \& postoperatively on day 7 and 30. Possible Risk (s): Risks of surgery(hemorrhage, endophthalmitis), Risks for investigations: minimal risk of infection To minimize the risk of infection: adherence to pre-\& intraoperative infection-control measures, postoperative UBM is to be done at 1 month.

Eligibility Criteria:
Inclusion Criteria:

* Age 40-70 years.
* Glaucomtous and nonglaucomatous participants with visually significant cataracts.
* Best-corrected visual acuity (BCVA) equal to or worse than 6/12.
* patients candidates for standard cataract surgeries without adjunctive procedure (e.g., pupil stretching or iris hooks).

Exclusion Criteria:

* Major intraoperative or postoperative complications from cataract surgery
* Peripheral anterior synechiae (PAS) detected by indentation gonioscopy.
* Uveitis, severe retinal diseases, or congenital Anomalies.
* History of ocular trauma or any intraocular Surgery. ocular trauma or any intraocular Surgery
A Bioequivalence Study Comparing HIP0901 Capsule With Lipidilsupra Tablet

The purpose of this study is to evaluate pharmacokinetics and safety after oral administration of HIP0901 capsules and Lipidilsupra tablets.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteers, age between 20 and 45
* Informed of the investigational nature of this study and voluntarily agree to participate in this study
* Weight\>50kg, BMI of \>18kg/m2 and \<27kg/m2 subject

Exclusion Criteria:

* Acute disease within 28 days prior to start of study drug administration
* Use of any prescription medication within 14 days prior to Day 1
* Use of any medication within 7 days prior to Day 1
* Has a severe medical history of hypersensitivity to fibric acid derivative
* Participation in another clinical study within 30 days prior to start of study drug administration
Study in COPD Patients Evaluating the Quality of Life (TRISNOOZE)

This non-interventional study aims to collect information on the patient's quality of life, as well as the quality of sleep when stepping up to a fixed triple maintenance therapy (Trimbow®) as per physicians' decision, independent from study participation, and to assess its effectiveness in daily life, in general practitioner setting.

This non-interventional study assesses the real-life effectiveness, with focus on patient's quality of life, of the fixed triple therapy Trimbow® after stepping up from a dual therapy in clinical practice at first line centres in patients with confirmed chronic obstructive pulmonary disease (COPD). Data will be collected on availability as per usual care at baseline, 3 and 6 months after inclusion.

Eligibility Criteria:
Inclusion Criteria:

* Patient has provided written informed consent
* Patient is aged 40 years or older
* Current or ex-smokers with a smoking history ≥ 10 pack years
* Patient is diagnosed with COPD, confirmed by post-bronchodilator spirometry (Tiffeneau index \<0.7; baseline or older spirometry)
* Patient is eligible for switch to triple therapy with at least 12 weeks of stable double inhalation therapy (ICS/LABA or LABA/LAMA) prior to enrolment to the study
* Patient is starting treatment with Trimbow® upon decision by their physician

Exclusion Criteria:

* Patients who are hypersensitive to one of the active substances or excipients
* Patients who are treated with triple therapy (via single or multiple inhalers) in the last 6 months prior to study enrolment
* Patients on ICS, LABA or LAMA monotherapy
* Patients with pneumonia and/or a moderate or severe COPD exacerbation not resolved ≥ 14 days prior to screening and ≥ 30 days following the last dose of oral/systemic corticosteroid (if applicable), or a respiratory tract infection not resolved ≥ 7 days prior to screening
* Patients participating simultaneously to other clinical trials or studies
Comparison of Peri Implant Soft Tissue Esthetics With Immediate Temporization With and Without Subepithelial Connective Tissue Graft

The aim of this study is to clinically evaluate peri-implant soft tissue esthetics around single delayed implants in the esthetic zone.

To compare the efficacy of soft tissue augmentation on the peri-implant soft tissue esthetics along with immediate temporization to immediate temporization only.

Population (P): patients with a single missing tooth in the esthetic zone Intervention (I): Delayed implant placement with immediate temporization and subepithelial connective tissue graft Comparator (C): Delayed implant placement with immediate temporization Primary outcome: Pink esthetic score (PES) Time frame: 6 months Study design: Randomized controlled clinical trial

Eligibility Criteria:
Inclusion Criteria:

1. Age \> 18 years old
2. Good medical and psychological health
3. Absence of untreated caries lesions and untreated/uncontrolled periodontal disease. If patients required periodontal treatment (non-surgical and/or surgical), this was arranged outside the study protocol and completed at least 30 days prior to the enrolment
4. Need of a single-tooth replacement in the aesthetic (incisor, canine or premolar) region
5. Willingness to sign the informed consent form

Exclusion Criteria:

1. Any known disease (not including controlled diabetes mellitus), infections or recent surgical procedures within 30 days of study initiation;
2. Chronic treatment (i.e., 2 weeks or more) with any medication known to affect oral status (e.g., phenytoin, dihydropyridine, calcium antagonists and cyclosporine) within 1 month before baseline visit;
3. Anticoagulant therapy with warfarin, clopidogrel, ticlopidine or once daily aspirin (more than 81 mg);
4. HIV or Hepatitis;
5. Physical handicaps that would interfere with the ability to perform adequate oral hygiene;
6. Alcoholism or chronic drug abuse;
7. Heavy smokers (\>10/cigarettes per day);
8. Lack of adequate primary stability at implant insertion that enables immediate provisionalization (insertion torque ca 30 Ncm).
A Radiolabeled Mass Balance Study of [14C]-Ertugliflozin (PF04971729, MK-8835) In Healthy Male Participants (MK-8835-038)

This is single dose study of radiolabeled \[14C\]-ertugliflozin (PF04971729, MK-8835) in healthy male volunteers to study the absorption, distribution, metabolism and elimination of ertugliflozin.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male participants with Body Mass Index of 17.5 to 30.5 kg/m2 and a total body weight \>50 kg (110 lbs)

Exclusion Criteria:

* Female participants. Participants enrolled in a previous radionucleotide study or who have received radiotherapy or exposed to significant radiation within 12 months prior to screening
Ortopod CZ Pilot Study

ORTOPOD PILOT STUDY is a non-randomized, non-interventional clinical study that addresses the issue of perioperative neurocognitive disorder (deterioration of cognitive functions in the preoperative and perioperative period) and its impact on the occurrence of postoperative delirium.

Respondents meeting the entry criteria will undergo elective orthopaedic surgery (total hip arthroplasty) under general or regional anaesthesia.

ORTOPOD PILOT STUDY is a non-randomized, non-interventional clinical study that addresses the issue of perioperative neurocognitive disorder (deterioration of cognitive functions in the preoperative and perioperative period) and its impact on the occurrence of postoperative delirium.

Respondents meeting the entry criteria will undergo elective orthopaedic surgery (total hip arthroplasty) under general or regional anaesthesia. Preoperatively, they will be examined using the ALBA and POBAV tests, which serve for rapid and indicative assessment of cognitive functions. Furthermore, the functional capacity of patients will be assessed using the Clinical Frailty Scale, and depression will be evaluated using the Geriatric Depression Scale (questionnaire).

After the procedure, during hospitalization in the ICU/PACU, screening for postoperative delirium will be conducted using the CAM-ICU tool.

The aim of the pilot study is to verify the methodology and obtain baseline data on the incidence of cognitive dysfunction, depression, and frailty preoperatively, as well as the incidence of postoperative delirium in this group of patients before submitting a grant to AZV ČR. The main research question will be whether preoperative cognitive decline (according to the ALBA and POBAV tests) is associated with the occurrence of postoperative delirium. The second research question will be what percentage of patients with preoperative cognitive deficit (according to the ALBA and POBAV tests) undergo elective total hip arthroplasty. Secondary outcomes will include whether there are differences in the ALBA and POBAV test results before and after surgery (cognitive decline after anesthesia and surgery), whether higher Clinical Frailty Scale scores are associated with the occurrence of postoperative delirium, and whether the results on the Geriatric Depression Scale change preoperatively and postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* Age over 65 years (inclusive)

  * Type of procedure: elective hip replacement (TEP) under general or regional anesthesia
* ASA classification I-III
* Absence of sensory impairment (blindness, deafness, deaf-blindness)

Exclusion Criteria:

* Glasgow Coma Scale of 14 or less
* Limited legal capacity
* Known psychiatric illness with the use of psychiatric medications
* Effect of premedication, psychiatric, and analgesic sedative drugs (at the time of cognitive function testing)
* Active oncological disease
* Chronic use of strong opioids
* Re-operation
A Study in Healthy Japanese Men to Test How Different Doses of BI 1569912 Are Taken up by the Body and How Well They Are Tolerated

The main objectives of this trial are to investigate safety and tolerability of BI 1569912 in healthy male Japanese subjects following oral administration of single rising doses and multiple doses.

Secondary objective is the exploration of pharmacokinetics (PK) of BI 1569912.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a medical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests
* Japanese ethnicity, according to the following criteria: born in Japan, have lived outside of Japan \<10 years, and have parents and grandparents who are Japanese
* Age of 18 to 45 years (inclusive)
* Body mass index (BMI) of 18.5 to 25.0 kg/m2 (inclusive)
* Signed and dated written informed consent prior to admission to the study, in accordance with Good Clinical Practice (GCP) and local legislation
* Subjects who agree to minimize the risk of making their partner pregnant by fulfilling any of the following criteria starting from the first administration of trial medication until 90 days after last administration of trial medication

  * Use of adequate contraception, any of the following methods plus condom: intrauterine device, combined oral contraceptives that started at least 2 months prior to the first drug administration.
  * Vasectomized (vasectomy at least 1 year prior to enrolment)
  * Surgical sterilization (including bilateral tubal occlusion, hysterectomy or bilateral oophorectomy) of the subject's female partner

Exclusion Criteria:

* Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
* Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 40 to 90 mmHg, or pulse rate outside the range of 40 to 99 beats per minute (bpm)
* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
* Any evidence of a concomitant disease assessed as clinically relevant by the investigator
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
* Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
* History of relevant orthostatic hypotension, fainting spells, or blackouts Further exclusion criteria apply.
The Potential Effects and Mechanisms of Flax Lignans on Type 2 Diabetes Mellitus

The purpose of the study is to improving the lipid profile and glucose control in type 2 diabetic patients with supplementation of flax lignans. We hypothesize that flax lignans supplement will improve the cholesterol profile and glucose control in type 2 diabetic patients.

The prevalence of type 2 diabetes is increasing dramatically in the last decade in China. Hyperlipidemia is a comorbid condition in type 2 diabetes and increase the adverse health outcomes. Flax lignans, a phytoestrogen found in flaxseed is thought to be the compound responsible for cholesterol-lowering effect of flaxseed. Our purpose is to improving the lipid profile in type 2 diabetic patients with supplementation of flax lignans.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed type 2 diabetes
* Age: 50-79 years old
* LDL-cholesterol more than 2.9 mmol/l

Exclusion Criteria:

* Current or previous (within 6 months) use of estrogen therapy
* Cancer
* Chronic gastrointestinal diseases
* Current use of antibiotics
* Any severe liver or renal diseases
* Systolic blood pressure more than 180 mmHg or phase 3 hypertension
* Any severe mental diseases
* Severe cardio- or cerebro-vascular diseases
An Advance Care Planning Programme for Persons With Early Stage Dementia in the Community

Advance care planning (ACP) has been widely advocated for persons with early stage dementia (PWEDs) and persons with mild cognitive impairment (MCI). This proposed study attempts to promote the uptake of ACP for this population and their family caregivers in the community and to examine the effects of an ACP programme "Have a Say" for this population. It is hypothesized that participants received the intervention will be more engaged in ACP and their dyadic concordance on end-of-life care preference with their family caregivers will be higher after the intervention.

This study aims to evaluate the impacts of an advance care planning (ACP) programme "Have a Say" for persons with early stage dementia (PWEDs) or MCI and their family caregivers in the community. A quasi-experimental study with repeated blinded outcome assessment will be conducted to assess the effects of an ACP programme on dyads of PWEDs or persons with MCI and their family caregivers recruited from elderly community centres. Individuals who have a clinical diagnosis of any form of dementia at the early stage or MCI or have a Global Deterioration Score (GDS) 3 or 4 will be eligible to this study. Participants will receive a 4-session ACP programme. It includes an educational component, guided reflection and ACP discussion through a series of group-based activity and dyadic discussion delivered by trained ACP facilitator and guided by an ACP booklet. Dyads of participants will be provided with information about the trajectory of dementia, their future healthcare needs and caring options. Their values and care preferences on future care will be elicited in a consistent manner. They will be supported to have an individualized ACP discussion. The primary study outcome is the ACP engagement level of PWEDs. Secondary outcome is the dyadic concordance on end-of-life care preference. Adverse outcomes such as depression and caregivers' burden will also be evaluated. Data collection will be conducted at baseline, immediately after, and one-month after the intervention.

Eligibility Criteria:
Inclusion Criteria:

* aged 55 years or over;
* being Chinese,
* being a Cantonese speaker,
* having a Global Deterioration Scale score 3 or 4,
* having a designated family caregiver willing to participate in this study

Exclusion Criteria:

* non-communicable,
* mentally incompetent,
* received an ACP intervention,
* have previously signed an advance directive,
* have other life-limiting chronic illnesses with a life expectancy of less than 6 months.
CART-PSMA Cells for Advanced Prostate Cancer

This is a single center, open-label phase 1 study to assess the safety and feasibility of PSMA-specific CAR modified autologous T cells (CART-PSMA cells) in patients with advanced prostate cancer.

Part A (Dose Escalation) + Part B (Expansion Cohort) total up to 20 patients enrolled.

Eligibility Criteria:
Inclusion Criteria:

1. All participants must have the ability to understand and the willingness to sign a written informed consent.
2. Histologic confirmation of prostate cancer.
3. Tumor expressing PSMA as demonstrated by immunohistochemistry analysis or other methods.
4. Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2.
5. Under general air conditions, blood oxygen saturation \>90%.
6. Adequate liver function, specifically alanine aminotransferase (ALT) \< 3 times of upper limit of normal (ULN), aspartate transferase (AST)\< 3 times of ULN, serum bilirubin and alkaline phosphatase \< 2 times of ULN.
7. Adequate renal function, specifically serum creatinine \< 2.0 mg/dl.
8. Adequate cardiac function, specifically left ventricular ejection fraction (LVEF)≥50%.
9. Hemoglobin concentration ≥80g/L.
10. The side effects brought by the latest treatment should be recovered, and the latest chemotherapy should be at least 7 days before; At least three t½ have passed since the latest immunotherapy.

Exclusion Criteria:

1. Patients with other malignant tumors or major diseases.
2. Patients who are already undergoing other clinical drug trials or other gene therapy or cell therapy.
3. Patients with uncontrolled active infection.
4. Patients with active hepatitis B or hepatitis C infection.
5. Patients with human immunodeficiency virus (HIV) infection.
6. Patients who are being treated with immunosuppressive agents or systemic steroids (other than inhalation therapy).
7. Patients with various types of serious heart disease or a history of severe cerebrovascular disease.
8. Patients with congenital immune deficiency diseases or bone marrow deficiency diseases.
9. Patients with active autoimmune disease, including connective tissue disease, uveitis, inflammatory bowel disease, or multiple sclerosis; or a history of severe (as judged by the physician-investigator) autoimmune disease requiring prolonged immunosuppressive therapy.
10. Patients with active medical condition that, in the opinion of the physician-investigator, would substantially increase the risk of uncontrollable CRS (cytokine release syndrome) or CAR Neurotoxicity.
A Carbohydrate-restricted Diet to Reverse Fatty Liver in Adolescents With Obesity

The purpose of this study is to determine the effects of a low carbohydrate diet vs a low fat diet on improvement in aminotransferases, hepatic fat infiltration, markers of inflammation, insulin resistance, and body composition in obese adolescents with non-alcoholic fatty liver disease (NAFLD).

NAFLD is the most common form of liver disease in children in the United States. Currently, there is no treatment for NAFLD. In adults, weight loss through caloric restriction is commonly recommended to improve fatty liver. Weight loss is particularly difficult for children to achieve and significant caloric restriction may not be a prudent recommendation in developing children and adolescents. Because of this difficulty with weight loss in children, many children go on to develop cirrhosis and eventually undergo liver transplant. Data on the effectiveness of diet to reverse fatty liver and prevent progression to cirrhosis in children is urgently needed. To date, no studies have been done examining how changes in diet composition without intentional caloric restriction influences NAFLD in children. Data from previous studies in adults support the hypothesis that consumption of lower-CHO, higher-fat food sources rich in high-quality proteins and essential fatty acids has beneficial effects on metabolic health in adults without restricting calories. This study aims to test the hypothesis that a low CHO higher- fat diet will induce rapid reversal of fatty liver while also depleting of total and abdominal adiposity, preserving lean mass, and reducing inflammation in adolescents with obesity and NAFLD.

Eligibility Criteria:
Inclusion Criteria:

* Overweight/obese (BMI over the 85th percentile) male and female adolescents (age range 10-17) with elevated serum aminotransferase levels, diffusely echogenic liver via ultrasound suggestive of fatty liver, and/or prior diagnosis of NAFLD. Participant eligibility will depend on the ability of one parent to attend the initial diet instruction and individual counseling sessions with the registered dietitian during week 2, 4 and 6 of the diet intervention.

Exclusion Criteria:

* Presence of hepatic virus infections (HCV RNA-polymerase chain reaction negative; hepatitis A, B, C, D, E, and G; cytomegalovirus; and Epstein-Barr virus), alcohol consumption, history of parenteral nutrition, and use of drugs known to induce steatosis (for example, valproate, amiodarone, or prednisone) or to affect body weight and carbohydrate metabolism. Autoimmune liver disease, metabolic liver disease, and Wilson's disease will be ruled out by the participants physician prior to enrollment in the study.