cyrilzakka/clinical-trials huggingface dataset:
Comparison of Toric IOL Implantation and Opposite Clear Corneal Incision During Cataract Surgery to Correct Corneal Astigmatism

With increasing demands of patients concerning refractive outcome after cataract surgery, toric intraocular lenses (IOLs) that correct corneal astigmatism have been introduced more widely to cataract surgery. Originally toric IOLs were used mainly for patients with high degrees of astigmatism, especially after corneal surgical procedures such as penetrating keratoplasty. Since a couple of years, toric IOLs are available from numerous manufacturers to correct lower amounts of astigmatism which are much more prevalent with about 30% having a corneal astigmatism of 0.75D or more in the cataract population. This should result in less spectacle dependence of patients due to the astigmatic correction.

The alternative method to reduce corneal astigmatism as part of cataract surgery is to make incisions on the steeper axis of the cornea such as limbal relaxing incisions or an additional clear corneal incision opposite (OCCI) to the main cataract opening. These techniques are in use since more than 2 decades and are widely used in clinical routine. As with toric IOLs, precise alignment of the cuts with the axis of astigmatism is essential. The disadvantage of the incisional techniques is the variability of the effect between patients since it depends on factors such as the extent of scaring of the cuts after surgery as well as corneal thickness. The main advantage is the simplicity of the technique and the lower cost.

Aim of this study is to compare toric IOL implantation and opposite clear corneal incision during cataract surgery to correct corneal astigmatism.


Eligibility Criteria:
Inclusion Criteria:

* Cataract
* Age 21 and older
* Regular corneal astigmatism 1.0 up to 2.5 D
* written informed consent prior to surgery

Exclusion Criteria:

* Relevant other ophthalmic diseases such as: pseudoexfoliation, glaucoma, traumatic cataract corneal scars, and other co-morbidity that could affect capsule bag stability ( e.g. Marfan syndrome)
* Irregular corneal astigmatism on corneal topography
Expression and Localization of FP Prostaglandin Receptor in Human Ocular Tissues

to approve the expression of PGF2α receptors in hair follicle in ocular skin tissue, explaining the hypertrichotic effect of PG analogues as intraocular pressure lowering treatment.

50 hair follicle dissection - human lower lid skin and lashes will be derived from lateral tarsal strip (LTS) dissected routinely in ectropion repair surgery, the skin strip is dissected routinely in this surgery , without any relation to our study. The study will be planned according to Helsinki declaration for Paraffin embedded LTS tissue sections (4 µ) will be processed and examined in immunohistochemistry lab. FP receptor proteins expression, using subtype-specific polyclonal antibodies, will be detected by the light microscopic level, according to manufacturer instruction.

Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years
* malposition of lower eyelid

Exclusion Criteria:

* age \< 18 years
Group and Mobile Care for Gestational Diabetes

A critical variation in the provision of prenatal care to women with GDM is the need to keep patients engaged with their care between visits by tracking glucose levels using finger sticks and making dietary and other lifestyle modifications to keep these levels at or close to normal. Multiple studies have demonstrated that the use of mobile devices can improve medical outcomes. In order to keep patients engaged between appointments and improve self-care/lifestyle, we will study the use of a glucose monitoring system with nutrition therapy called GlucoseMama(GM). GM is a mobile app on the iOS system that individuals with GDM will use to tract blood sugars and number of carbs consumed. In addition, it will give the user positive feedback and rewards for using the system. This model of group care with mobile phone monitoring and reminders for women with GDM has not been previously studied. A randomized control trial is purposed to determine if this approach improves patient care. The investigators hypothesize that group prenatal care along with inter-session mobile therapy will increase dietary compliance and therefore reduce the number of individuals requiring pharmacologic therapy and improve neonatal outcomes during pregnancy. Group prenatal care (GPC) will provide a community foundation to improve learning and increase the motivation of patients to learn and change. This motivation will be further strengthened by the use of the GlucoseMama monitoring system which will provide each patient with glucose tracking and individualized nutritional support.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Gestational Diabetes
* Planning on delivering at home institution

Exclusion Criteria:

* Unwilling to participate.
Osteocrin and Vascular Complications

In this study, we aimed to describe the role of bone-derived factor (osteocrin) in glucose metabolism, micro and macrovascular complications in diabetic patients. Thus, further investigations of the endocrine system through bone-derived hormones may provide as new perspectives on the prediction, prevention, and treatment of diabetes mellitus.

Diabetes mellitus (DM) remained the most common metabolic disorder worldwide occupying the 8th leading cause of death.\[1\] Defining new predictive biomarkers in diabetes would provide a window of opportunity for preventive and/or therapeutic interventions to prevent or delay the onset of irreversible long-term micro and or macro vascular complications. Progressive micro vascular vaso-degeneration is the major factor in progression of diabetic complications and contribute greatly to the increased mortality and morbidity. \[2\] Where Hemodynamic-mediated vascular injury was considered as one mechanism in the pathogenesis of diabetic nephropathy. \[3\] Bone disorders have been drawing attention as a novel diabetic complication, and diabetes is associated with an increased risk of osteoporotic fracture \[4-6\]. Bone is considered as an endocrine organ that influences various organs and tissues via the secretion of multiple bone derived hormones \[7-8\]. These endocrinal functions are, for example, glucose homeostasis \[9\], appetite control \[10\], fat deposition \[11\], skeletal muscle adaptation \[12\], male fertility \[13\], and cognition \[14\].

Therefore, these bone-derived hormones can become useful biomarkers for predicting the incidence of diabetes and the progression of diabetic complications. Osteocrin (OSTN), a bone-derived humoral factor, is a small secreted peptide cloned from bone and muscle complementary DNA (cDNA) libraries \[15\]. Osteocrin (Ostn) is secreted protein produced by cells of the osteoblast lineage that shows a well conserved homology with members of the natriuretic peptide (NP) family with prohormone-like characteristics \[17\]. To date, the exact role of Ostn has not been elucidated.

In this study, we aimed to describe the role of bone-derived factor (osteocrin) in glucose metabolism, micro and macrovascular complications in diabetic patients. Thus, further investigations of the endocrine system through bone-derived hormones may provide as new perspectives on the prediction, prevention, and treatment of diabetes mellitus.

Eligibility Criteria:
Inclusion Criteria:

- Cases of the study will select randomly, based on inclusion criteria that included

* Patients were diagnosed with diabetes mellitus according to American Diabetes Association
* Age range 20-70 years
* No apparent vascular abnormalities and Acute complications

Exclusion Criteria:

* Patients are excluded for participation in the study if

  * Patients had past history of cardiovascular events (heart failure or history of coronary artery disease),
  * infections,
  * aacute diabetic complications,
  * diabetic patients on regular hemodialysis .
  * acute illness, malignancy, or pregnancy.
Prospective Assessment of Robotic Sacrocolpopexy: a European Multicentric Cohort (PARSEC)

The purpose of this study is to prospectively assess the outcomes of robotic sacrocolpopexy for repair of pelvic organ prolapse in high volume european centers.

To prospectively assess the outcomes of robotic sacrocolpopexy for repair of pelvic organ prolapse in high volume european centers.

Primary outcome: anatomical cure rate (using simplified POP-Q staging system)

Secondary outcomes:

complication assessment (Clavien-Dindo), functional results, intraoperative variables, impact of surgery on quality of life (PFIQ-7, PISQ-12)

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic vaginal vault prolapse with simplified pelvic organ prolapse quantification (POP-Q) stage 2 or greater

Exclusion Criteria:

* Poor health status with inability to undergo general anaesthesia
* Age \< 18 years
* ≥ 3 previous laparotomic surgeries
* Planned pregnancy
* Other: known pelvic malignancies, previous pelvic radiotherapy, congenital anomalies of genitourinary tract, autoimmune diseases with connective tissue involvement (Lupus, Sjogren Sdr, sclerodermia, etc.), current UTI's, use of steroids, anticoagulants, interstitial cystitis
Ori-C101Chimeric Antigen Receptor (CAR) Modified T Cells for the Treatment of HCC

This is a Phase I, open-label, multi-center study to assess the safety, pharmacokinetics, and preliminary efficacy of GPC3-directed chimeric antigen receptor modified T cells injection (Ori-C101) in Advanced Hepatocellular Carcinoma(HCC).


Eligibility Criteria:
Inclusion Criteria:

1. Confirmed pathologic or radiologic diagnosis of HCC ;
2. Tumor tissue GPC3 expression positive by immunohistochemistry(IHC) at the local laboratory (Tumor samples ≤1 years prior to ICF signature are acceptable), if no archived tumor tissue samples, tumor biopsy is required for GPC3 expression test;
3. Unresectable stage B (intermediate) or C (advanced) HCC according to the Barcelona Clinic Liver Cancer (BCLC) staging. If stage B, must have progressed after, or not be eligible for, surgical or locoregional therapy;
4. Received at least two prior line of systemic therapy (included but not limited to target therapy, immunotherapy or chemotherapy) with radiologic disease progression during or following systemic therapy;
5. Child-Pugh A or B7, no history of hepatic encephalopathy;
6. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 at the time of ICF signature;
7. Estimated life expectancy of minimum of 12 weeks;
8. Must have at least 1 target lesion

Exclusion Criteria:

1. Central nervous system metastatic disease, leptomeningeal disease, or metastatic cord compression;
2. Prior bone marrow or organ transplantation;
3. Have a history of another primary malignancy within 5 years prior to starting study treatment. Exceptions here are as follows: the disease under study; adequately treated basal or squamous cell carcinoma of the skin; cancer of the cervix in situ;
4. Active hepatitis B infection (If Hepatitis B surface antigen \[HBsAg\] or Hepatitis B core antibody \[HBcAb\] positive, then HBV-DNA must be \< 20 IU/mL, and HBsAg-positive patients should have been treated with antiviral therapies as per the local guidelines);
5. Positive hepatitis C (HCV) RNA, Human Immunodeficiency Virus (HIV) antibody, Cytomegalovirus(CMV) DNA or syphilis serology;
6. Have received prior cell-based therapies such as targeted GPC3 therapy, TCR-T therapy, CAR-T therapy;
7. Inadequate bone marrow reserve or organ function;
8. History or current evidence of any condition or disease that could confound the results of the study or, in the opinion of Investigator, is not in the best interest of the patient to participate.
9. Pregnant or Breast-feeding women.
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of BMS-986489 in Chinese Participants With Relapsed/Refractory Small Cell Lung Cancer

The purpose of this study is to characterize the safety, tolerability, pharmacokinetics, and preliminary efficacy of BMS-986489 in Chinese participants with R/R SCLC (Relapsed/Refractory Small Cell Lung Cancer).


Eligibility Criteria:
Inclusion Criteria:

- Participants must have histologically or cytologically documented SCLC (small cell lung cancer). Participants with either limited or extensive disease stage at the initial diagnosis, who have received at least one prior line of systemic therapy, are eligible.

i) For initial limited stage (LS) SCLC:.

A. Those who progressed or recurred after more than 6 months treatment-free interval following treatment of curative surgical resection, systemic therapy, or radiotherapy, and subsequently received at least one line of systemic therapy to treat the recurrence or progression, and then progressed, or were intolerant to the prior systemic therapy per the assessment of investigators, these participants will be eligible, or

B. Who progressed or recurred within 6 months after treatment of curative surgical resection, systemic therapy, or radiotherapy, no matter if these participants have received subsequent systemic therapy, these participants will be eligible.

ii) For initial extensive stage (ES) SCLC, participants must have received at least one line of platinum-based systemic therapy (with/without immunotherapy), and then progressed, or been intolerant to the prior systemic therapy per the assessment of investigators.

A. Note: 1) For ES-SCLC with only one line of platinum-based regimen as well as chemotherapy-free interval is more than 6months when progression, only when participants refuse or are ineligible for re-treatment with platinum-based doublet per the assessment of investigators, these participants will be eligible. 2) If participants receive re-treatment with a platinum-based regimen, it is considered a second line of therapy.

* Participants must have a life expectancy of ≥12 weeks.
* Participants must have at least 1 measurable lesion outside the central nervous system (CNS) by computed tomography (CT) or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria.
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.

Exclusion Criteria:

* Untreated symptomatic CNS metastases.
* Leptomeningeal disease.
* Pleural effusion which cannot be controlled with appropriate interventions.
* Malignancy-related superior vena cava syndrome.
* Participants with an active, known or suspected, autoimmune disease.
* Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to first study treatment.
* Unresolved toxicity from prior anti-tumor therapy.
* Prior treatment with an anti-fuc-GM1 therapy or any other drug specifically targeting fuc-GM1.
* Other protocol-defined inclusion/exclusion criteria apply.
Histopathological Diagnosis of Adenomyosis

The purpose of this study is to develop and evaluate a hysteroscopic endo-myometrial biopsy for diagnosing adenomyosis.


Eligibility Criteria:
Inclusion Criteria:

* females complaining of pelvic congestion: dysmenorrhea, dyspareunia, chronic pelvic pain, menorrhagia, metrorrhagia

Exclusion Criteria:

* refusal of the patient to get enrolled in the study
Cytosponge and Dietary Therapy in EoE

This study is being done to see if the investigators can use only the cytosponge ( A 10 minute, in office procedure that does not require sedation) to replace the 6-10 endoscopies routinely perform during dietary restriction and food reintroduction in EoE?

Dietary Therapy has been shown to be successful in the treatment of adult and pediatric patients with eosinophilic esophagitis Dietary studies were initially reported in children, but the results appear to be similar in adult patients. Elemental diets are successful in 70-95% of patients but are poorly tolerated. A six food elimination diet has been effective in about 70% of adult patients with EoE . In these adult studies skin prick testing was not helpful in predicting which foods would lead to a flare of disease when reintroduced into the diet. Therefore, the current standard of care requires multiple EGDs with esophageal biopsy during the dietary restriction and reintroduction phases of this study. Since the investigators are making lifelong dietary decisions during this process of food reintroduction, it is imperative the investigators be accurate. Unfortunately, these multiple EGDs have significant cost and are invasive procedures with some risk. Moreover, there is significant indirect costs with travel and time off work for the patients and drivers. Previous studies have found the esophageal sponge to be an accurate technique of accessing esophageal eosinophilia in EoE . The sponge is swallowed as a 12 mm capsule on a string. The capsule rapidly dissolves upon entering the stomach and the sponge then expands and can be pulled out the mouth five minutes after ingestion. In previous studies, the procedure was very well tolerated and all patients preferred the sponge to endoscopy.

Therefore the sponge is a well tolerated, inexpensive, very low risk procedure that would be an ideal option to replace EGD esophageal sampling in the evaluation of dietary treatment of EoE.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with Eosinophilic Esophagitis \> than 15 Eos phf and failed to respond to the PPI therapy
* Going through the six food elimination diet or have just completed elimination the six foods: fish, nuts, eggs, soy, wheat, and milk

Exclusion Criteria:

* Clinical evidence of infectious process potentially contributing to dysphagia ( candidiasis, CMV, herpes)
* Other cause of dysphagia identified at endoscopy (e.g. reflux esophagitis, stricture, web, ring, achalasia, esophageal neoplasm)
* Esophageal minimal diameter \< 13 mm on structured barium esophagram
Sodium Nitrate for Muscular Dystrophy

The investigators' previous work in males with Becker Muscular Dystrophy shows that functional sympatholysis is restored by acute inorganic nitrate supplementation. This was translated from work using the mdx mouse model of dystrophinopathy. Recent work has shown that there is a frank improvement in grip strength when mdx mice are treated with an inorganic Nitric Oxide (NO) donor. The purpose of this study is to determine if chronic treatment with an inorganic NO donor can benefit patients with muscular dystrophy beyond blood flow regulation.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of muscular dystrophy
* Age 15-45 years of age
* Ambulatory
* No clinical evidence of heart failure
* Maximum voluntary contraction, measured by hand grip dynamometer, of 20-40 kg

Exclusion Criteria:

* Hypertension, diabetes, or heart failure by standard clinical criteria
* Elevated B-type Natruiretic Peptide level (\>100 pg/ml)
* Left Ventricular Ejection Fraction \< 50%
* Wheelchair bound
* Cardiac rhythm disorder, specifically: rhythm other than sinus, Supraventricular Tachycardia, atrial fibrillation, ventricular tachycardia
* Continuous ventilatory support
* Liver disease
* Renal impairment
* Contraindications to NO donors (use of nitrates, alpha-blockers, CYP3A inhibitors, amlodipine, or Phosphodiesterase type 5 (PDE5) inhibitors) Glucocorticoid therapy and prophylactic use of Angiotensin Converting Enzyme (ACE) inhibitors and beta-blockers for cardiac protection will not be exclusion criteria.
* Maximum voluntary contraction of less than 20 kg or greater than 40 kg
* Ventilation Devices (Continuous Positive Airway Pressure (CPAP), Bilevel Positive Airway Pressure (BiPAP))
The Effect of Terlipressin on Recovery of Liver Function After Hepatectomy

Portal vein hypertension is associated with post-hepatectomy liver failure in patients with liver cirrhosis. Our previous study found that bolus injection of 1 mg terlipressin immediately after hepatectomy decreased portal vein pressure, and post-operative continuous use of terlipressin decreased the amount of abdominal drain. In this multicenter randomized controlled study, we aim to evaluate the effects of terlipressin in the patients who underwent liver resection complicated by portal vein hypertension.

Portal vein hypertension is associated with post-hepatectomy liver failure in patients with liver cirrhosis. Our previous study found that bolus injection of 1 mg terlipressin immediately after hepatectomy decreased portal vein pressure, and post-operative continuous use of terlipressin decreased the amount of abdominal drain. In this multicenter randomized controlled study, we aim to evaluate the effects of terlipressin in the patients who underwent liver resection complicated by portal vein hypertension. The primary outcome is the total abdominal drain on postoperative day (POD) 1 to 3. The secondary outcomes are: (1) the incidence of post-hepatectomy liver failure; (2) post-operative acute kidney injury; (3) the side effects of terlipressin.

Eligibility Criteria:
Inclusion Criteria:

* Subjects signed informed consent.
* An open liver resection is planned.
* Hepatitis B virus infection background.
* Pre-operative liver function is Child-Pugh A.
* Subjects with clinical significance portal vein hypertension or the liver stiffness \> 12 kPa before surgery.
* Portal vein pressure \> 12 mmHg at 5 min after liver resection.

Exclusion Criteria:

* Age \< 18 y or \> 75 y.
* Subjects received anti-cancer therapy within 3 months before surgery, or with a history of open or laparoscopic surgery.
* Portal vein tumor thrombus was confirmed by preoperative imaging study.
* Obstruction of biliary tract.
* Pre-operative ALT or AST \> 2×ULN.
* A history of myocardial infarction or chronic kidney disease.
* Severe arrhythmia.
* Intraoperative portal vein pressure could not be measured technically.
* Any other contraindications of the terlipressin.
Effect of Delivery Route on PK of Sufentanil NanoTab

Determine whether the amount of drug absorbed is different if the tablet is placed under the tongue, placed between the cheek and gum, or swallowed.


Eligibility Criteria:
Inclusion Criteria:

* body mass index 18 - 30

Exclusion Criteria:

* pregnant females
* smokers
* pulmonary disease
* sleep apnea
Pharmacokinetic Study to Compare Absorption of Budesonide/Formoterol Easyhaler and Symbicort Turbuhaler

The purpose of this study is to compare Budesonide/formoterol Easyhaler test products with the marketed product Symbicort Turbuhaler in terms of the drug absorbed into the bloodstream.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent obtained
* Body mass index \> 19 and \< 30kg/m2, weight at least 50 kg
* Good general health ascertained by detailed medical history, and laboratory and physical examinations

Exclusion Criteria:

* Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, GI, pulmonary, metabolic-endocrine, neurological or psychiatric disease
* Any condition requiring regular concomitant treatment (including vitamins and herbal products) or likely to need any concomitant treatment during a study.
* Known hypersensitivity to the active substance(s) or the excipient of the drug
* Pregnant and lactating females
A Comparison of Colonic Bile Acid Content Following Right and Left Colectomies

The aim of this study is to evaluate whether there is a difference in the bile acid content in the bowel in patients after right versus left colectomy. There is compelling evidence that patients under going resection of the right colon versus left coolon have a lower polyp detection rate in surveillance colonoscopies. The investigators intend to evaluate feces of patients undergoing left and right colectomies; prior to their surgery and again three and six months aftet the surgery. The investigators plan to compare the content of the different bile acids and to compare the content between the two groups.


Eligibility Criteria:
Inclusion Criteria:

* Age above 18.
* Patients intended to undergo a colectomy for colonic cancer
* Patients willing and participate and able to sign an informed consent

Exclusion Criteria:

* Age under 18.
* Patients with Inflammatory Bowel Disease (Crohn's, Ulcerative colitis).
* Patients refusing to participate or are unable to understand or sign an informed consent