cyrilzakka/clinical-trials huggingface dataset:
Budesonide for Immunosuppression After Liver Transplantation to Reduce Side Effects

Our hypothesis is that budesonide will provide effective hepatic ISP that will replace prednisone and allow lower systemic drug levels of FK, thus reducing the steroid- and calcineurin-associated complications often observed in the OLT population. This study is intended to investigate the therapeutic potential of this ISP combination.

This study will be a randomized, open-label non-inferiority trial to assess the efficacy, safety and tolerability of budesonide in combination with low-dose FK and standard-dose MMF as post-OLT ISP in comparison to standard ISP (S-ISP). Subjects will include OLT patients age 18 years and older receiving their first single-organ living- or deceased-donor liver transplant. Subjects must have post-operative recovery of graft function and be able to take oral medications before beginning treatment according to the study protocol.

Subjects will be randomized to receive either (1) investigational oral ISP including budesonide 9mg by mouth in three daily divided doses, FK with an initial target trough level of no greater than 5-6ng/mL, and MMF (I-ISP); or (2) S-ISP including prednisone, calcineurin antagonist, and MMF. After randomization, subjects will be followed for a total of 52 weeks and assessed for adequacy of graft function, and complications of therapy, particularly ACR

Eligibility Criteria:
Inclusion Criteria: Adult patients age 18 years or older who undergo initial single-organ living- or deceased-donor liver-transplant surgery. Research participants are required to have satisfactory post-operative recovery of graft function and no post-operative renal-replacement therapy prior to starting medication according to protocol. They must also be able to take oral medications.

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Exclusion Criteria: Patients will be excluded from the study if they are: (1) undergoing retransplantation; (2) have fulminant hepatic failure as an indication for liver transplantation; (3) have surgical complication(s) potentially affecting post-operative graft function (i.e., hepatic artery thrombosis); or have delayed initial recovery of graft function (primary non-function) requiring non-standard induction therapy. Furthermore, patients with a contraindication to budesonide (i.e., hypersensitivity) will not be included in the study

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SynKIR-110 for Mesothelin Expressing Ovarian Cancer, Cholangiocarcinoma or Mesothelioma

This first-in-human (FIH) trial is designed to assess the safety, feasibility, and potential activity of a single intravenous (IV) dose of SynKIR-110 administered to subjects with mesothelin-expressing advanced ovarian cancer, mesothelioma, and cholangiocarcinoma.

This is a Phase 1, FIH, multicenter, open-label, dose-escalation pilot study of a single IV gravity drip infusion of SynKIR-110 in subjects with advanced, mesothelin-expressing tumors (ovarian cancer, primary peritoneal cancer, fallopian tube cancer, cholangiocarcinoma, or mesothelioma). Up to 42 subjects will be assessed to determine the safety and feasibility of treatment with SynKIR-110. Informed consent will be obtained from subjects prior to participation in this study.

The study includes an enrollment screening period (which includes pre-leukapheresis safety/eligibility and leukapheresis visits), treatment period (administration of non-myeloablative lymphodepleting chemotherapy followed by a single infusion of investigational product), and a 12-month follow-up period or until disease progression. Subjects will be followed for 12 months or until confirmed disease progression, whichever occurs first, at which point they will be invited to participate in a long-term safety follow-up study.

Up to 6 cohorts of 3 to 6 subjects per cohort will be treated to determine the safety and feasibility of treatment with SynKIR-110. Doses will be escalated following a standard 3 + 3 design until either an MTD or MFD is reached. An additional 6 to 9 subjects will be treated at the MTD/MFD to further assess safety and potential activity of SynKIR-110.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed recurrent or relapsed advanced ovarian cancer, primary peritoneal cancer, fallopian tube cancer, cholangiocarcinoma, or epithelial mesothelioma (pleural or peritoneal) after at least 1 prior line of systemic therapy for advanced disease
* Adult 18 years of age or older.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
* Has at least 1 measurable lesion by iRECIST for ovarian cancer or cholangiocarcinoma or lesions measurable for mRECIST for mesothelioma.
* Satisfactory Blood coagulation parameters
* Satisfactory organ and bone marrow function

Exclusion Criteria:

* Active invasive cancers other than mesothelioma, cholangiocarcinoma, and ovarian unless surgically and medically cured without evidence of recurrent disease for 5 years.
* History of T or B cell malignancies or previous gene-engineered T cell therapies.
* Sarcomatoid/biphasic mesothelioma.
* Pulmonary exclusions
* Have acquired hereditary, congenital immunodeficiency or have recognized immunodeficiency disease
* Active hepatitis B, active hepatitis C, or any HIV infection at the time of screening
* Active autoimmune disease
Anti-Xa Assay Correlation to the Efficacy and Safety of Enoxaparin in the Treatment of Pulmonary Embolism

The aim of the present study is to monitor anticoagulant therapy by anti-Xa assay and correlate its level to the efficacy and safety of enoxaparin in the treatment of pulmonary embolism.

This prospective randomized trial was conducted on 42 patients 18 years of age or older in ICU diagnosed to have pulmonary embolism and confirmed by the presence of intraluminal filling defect in CT pulmonary angiography and treated with subcutaneous enoxaparin 1 mg/kg/12 hours. The study was conducted from August 2013 to September 2016.

All the patients were examined daily over a period of 4 weeks for symptoms and signs of recurrent pulmonary embolism (recurrent pulmonary embolism was diagnosed if the repeat CT angiography revealed a new sudden arterial branch cutoff or a new intraluminal filling defect that was not present on the first angiogram), Platelet count (patients with platelet count less than 50,000/mm3 or those with bleeding and platelet count between 50,000 and 100,000/mm3 are considered having severe thrombocytopenia), bleeding (defined as major overt bleeding requiring blood transfusion \> 2 units or marked hemoglobin drop \> 2 gm/dl or if the bleeding was intracranial or retroperitoneal) and death (defined as all deaths occurring within the 4 weeks of the study) , Then the results were correlated to anti-Xa assay.

Eligibility Criteria:
Inclusion Criteria:

* Patients in ICU and diagnosed to have pulmonary embolism and confirmed by the presence of intraluminal filling defect in CT pulmonary angiography and treated with subcutaneous enoxaparin 1 mg/kg/12 hours.

Exclusion Criteria:

* Patients who underwent thrombolysis, embolectomy or if they are unfit for anticoagulant therapy because of major bleeding or thrombocytopenia (a platelet count below 100,000 per cubic millimeter). Patients were also excluded if they had impaired kidney function with a serum creatinine level above 2 mg/dl or uncontrolled hypertension (blood pressure \> 160/100 mmHg).
Application of Stress Ball and Non-stress Test With Pregnant Women

This research was planned as a randomized controlled experimental study to reduce the anxiety expectant mothers feel when on a non-stress test.

Fetal well-being is assessed by evaluating fetal heart rate (FHR) patterns. The primary aim is to identify fetuses at risk of intrauterine death or neonatal complications and, if possible, intervene (usually by delivery) to prevent these adverse outcomes. The most commonly used method for this purpose is the non-stress test. Non-stress test (NST) is a non-invasive fetal evaluation method. The NST is evaluated for at least 20 minutes while the expectant mother is lying supine or left-side.

Although it is a painless procedure, it takes about 20 minutes, and the pregnant woman stays in the same position throughout the procedure, creating although there are many methods to reduce stress, it is thought that a cheap and easily accessible stress ball can be used as a method of distraction or distraction. Although there are studies investigating the effectiveness of stress balls in managing various disease groups and symptoms in the literature, no study has been found to examine the NST effectiveness of stress balls. This research was planned as a randomized controlled experimental study to reduce the stress felt by women who had a non-stress test during pregnancy by applying a stress ball during the procedure. anxiety for the pregnant woman. The fact that the pregnant woman has high anxiety during the procedure affects the test result and may increase the false-positive rate and cause false evaluation. This increase in the false-positive rate in NST results may lead to an increase in an operative delivery. However, it is the midwives' responsibility to eliminate the situations that cause anxiety in pregnant women, which may affect the NST result before and during the procedure.

Eligibility Criteria:
Inclusion Criteria:

* Ability to read and understand Turkish
* Being between the ages of 20-35
* Single pregnancy
* Having had NST before

  ¬- Have eaten at least 2 hours before the NST procedure
* Don't be primiparous
* Getting 37 or less on the trait anxiety (STAI-1) scale
* Getting 37 or more on the state anxiety (STAI-2) scale
* Volunteering to participate in the research
* Fully answering survey and scale forms
* Being in the 3rd trimester

Exclusion Criteria:

* Having been diagnosed with a risky pregnancy
* Unwilling to continue working
* Having a chronic disease (Diabetes, Hypertension, Thyroid etc.),
* Having any problem that prevents communication (such as hearing, speaking, and understanding abilities),
* Using one of the pharmacological or non-pharmacological methods to reduce stress and receiving psychiatric treatment (Pharmacotherapy or psychotherapy).
eLIFEwithIBD - Living With Intention, Fullness and Engagement With Inflammatory Bowel Disease (Online)

This study aims to test the acceptability and preliminary efficacy of an online intervention (eLIFEwithIBD) developed for people with inflammatory bowel disease (IBD). The eLIFEwithIBD intervention is an adaptation of the LIFEwithIBD program (delivered in an in-person group format; Trindade et al., 2021), being an ACT, mindfulness, and compassion-based intervention. The eLIFEwithIBD intervention comprises nine sessions focusing on education about IBD, the functioning of the mind, emotions, and fatigue; acceptance of internal experiences; willingness; emotion regulation; values clarification; committed action; mindfulness; compassion; and gratitude. These topics are addressed through videos with therapists, texts, and experiential exercises.


Eligibility Criteria:
Inclusion Criteria:

* aged between 18 and 65;
* IBD diagnosis (at least from 6 months prior);
* regular access to a computer with internet;
* able to write and read in Portuguese, and give informed consent.

Exclusion Criteria:

* diagnosis of a psychiatric disorder (major depressive disorder, psychotic disorder, bipolar disorder, substance abuse), or suicidal ideation (assessed by the Patient Health Questionnaire-9);
* current psychotherapy use;
* pregnancy.
Safety and Efficacy of Cocktail Periarticular Injection in Simultaneous Total Knee Arthroplasty

We investigated the safety and efficacy of the bilateral periarticular cocktail injection at a reduced dosage in patients undergoing simultaneous bilateral total knee arthroplasty.

It is hypothesized that intraoperative periarticular injection with cocktail analgesics can reduce postoperative parenteral narcotics use and improve patient satisfaction following total knee arthroplasty.

A prospective, randomized trial is conducted to testify the hypothesis above by recruiting patients who go through simultaneous bilateral TKA and observing their postoperative analgesic consumption, visual analog scores and functional recovery. Potential side-effects of the multimodal drugs is also under observation.

Eligibility Criteria:
Inclusion Criteria:

* patients with tricompartmental knee disease undergoing simultaneous bilateral TKA

Exclusion Criteria:

* diabetes mellitus
* neuromuscular deficit
* a known allergy to one of the drugs being injected
* a history of cardiac disease or arrhythmia requiring special monitoring
Transcranial Electrical Stimulation (TES) for the Treatment of Depression.

This study is a RCT of transcranial electrical stimulation in depressed patients. Mood, cognitive test performance and biomarkers will be measured during the trial.


Eligibility Criteria:
Inclusion Criteria:

* DSM-IV Major Depressive Episode (as part of a Major Depressive Disorder or Bipolar Disorder), of minimum 4 weeks duration.
* MADRS score ≥ 20 at study entry.

Exclusion Criteria:

* DSM-IV psychotic disorder;
* drug or alcohol abuse or dependence (preceding 12 months);
* inadequate response to ECT (current episode of depression);
* anticonvulsant or benzodiazepine medication;
* rapid clinical response required, e.g. high suicide risk; clinically defined neurological disorder or insult;
* metal in the cranium, skull defects, or skin lesions on scalp (cuts, abrasions, rash) at proposed electrode sites;
* pregnancy.
Gripwise® Versus JAMAR®

It is recommended to screen ageing patients for sarcopenia, due to the increased risk of morbimortality if detected positive. According to the consensus of the European Working Group on Sarcopenia in Older People, the diagnosis of sarcopenia is based, among other things, on grip strength measurement.

Our study will compare the performance of the new GRIPWISE digital device with the mechanical dynamometer JAMAR, the gold standard currently used to assess the grip strength. We propose to evaluate it in an elderly hospitalized population where the prevalence of sarcopenia is likely to be high due to the high prevalence of various chronic illness, notably oncological and cardiological ones.

This cross-sectional study will include 348 patients.


Eligibility Criteria:
Inclusion Criteria:

* men and women aged 65 or over
* affiliated to a health insurance
* Francophone.

Exclusion Criteria:

* - refusal to participate
* unable to communicate
* unable to use both hands (dominant and non-dominant)
Infrared Non-Cutting Laser Therapy for Acne

The purpose of this research project is to study the effect of non-ablative (non-cutting) laser therapy, a technique that uses laser energy to try to improve the appearance of the skin. In this study, we are interested in learning how well such a laser works to improve the symptoms of acne. The laser used in this particular study will be the CoolTouch II® laser, manufactured by ICN Photonics, Inc., and has not been FDA-approved for the treatment of acne.

The purpose of this research project is to study the effect of non-ablative (non-cutting) laser therapy, a technique that uses laser energy to try to improve the appearance of skin. This type of laser treatment creates changes in a layer of the skin called the dermis without causing an open wound in the skin. It is not yet clear how much improvement can be seen with these treatments or exactly how the skin's response causes these improvements. In this study, we are interested in learning how well such a laser works to improve the symptoms of acne. The laser used in this particular study will be the CoolTouch II® laser, manufactured by ICN Photonics, Inc., and has not been FDA-approved for the treatment of acne.

Eligibility Criteria:
Inclusion Criteria:

* Age 13 years or older of either gender and of any racial/ethnic group.
* Subjects must have clinically evident acne vulgaris of the facial skin.
* Subjects must understand and sign the informed consent prior to participation.
* Subjects must be in generally good health.
* Subjects must be able and willing to comply with the requirements of the protocol.
* You must live within a reasonable driving distance of Ann Arbor, Michigan, and/or be able to attend all of the scheduled appointments during the study.

Exclusion Criteria:

* Oral retinoid (Accutane) use within 1 year of entry into the study.
* Systemic acne therapies (oral antibiotics) within 4 weeks of entry into the study.
* Topical acne therapies (retinoids, antibiotics) within 2 weeks of entry into the study.
* Microdermabrasion or superficial chemical peels at the sites to be treated within 3 months of entry into the study.
* Subjects with a history of dermabrasion or laser resurfacing at the sites to be treated.
* Use of topical lipid absorbing substances (Clinac AC) within 2 weeks of entry into the study.
* Non-compliant subjects.
* Subjects with a significant medical history or concurrent illness/condition which the investigator(s) feel is not safe for study participation.
* Subjects using alcohol-based topical solutions or "exfolliating" agents within 2 weeks of entry into the study.
* Subjects with a history of very frequent herpes simplex infections of the face or with clinical evidence of active herpes simplex infections.
* History of keloid scar formation for subjects undergoing biopsies.
* Pregnant or nursing females.
Hydrus® Microstent New Enrollment Post-Approval Study

The purpose of this post-approval study is to evaluate the rate of Hydrus Microstent malposition and associated clinical sequelae occurring within 24 months post-operation. Qualified subjects will undergo uncomplicated cataract surgery with placement of a monofocal intraocular lens (IOL), followed by implantation of the Hydrus Microstent.

Qualified subjects will attend a screening visit, a surgical visit (Day 0), and 8 scheduled postoperative visits at Day 1, Day 7, Month 1, Month 3, Month 6, Month 12, Month 18, and Month 24.

This study was initiated by Ivantis, Inc. Ivantis was acquired by Alcon Research, and Alcon assumed sponsorship of the study in November 2022.

Eligibility Criteria:
Inclusion Criteria:

* An operable, age-related cataract with best corrected visual acuity (BCVA) of 20/40 or worse;
* Diagnosis of primary open angle glaucoma treated with no more than 4 topical hypotensive medications;
* Optic nerve appearance characteristic of glaucoma;
* Medicated IOP less than or equal to 31 millimeters mercury (mmHg); Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Closed angle forms of glaucoma;
* Congenital or developmental glaucoma;
* Secondary glaucoma;
* Use of more than 4 ocular hypotensive medications;
* Previous argon laser trabeculoplasty, trabeculectomy, tube shunts, or any other prior filtration or cilioablative surgery;
* Prior surgery with implanted device or other surgery involving the trabecular meshwork or Schlemm's canal;
* Other protocol-defined exclusion criteria may apply.
Effect of Smart Phone App-based Human Coaching Program in Gastrectomized Patients

This study is a single center, prospective, randomized controlled study. The aim of this study is to evaluate the effect of smart phone app-based human coaching program on QOL in patients who underwent gastrectomy for stage I gastric cancer. The hypothesis of this study is the patients who used smart phone app-based human coaching program for three months after surgery will have better QOL than patients who did not use it. The QOL will be assessed using EORTC QLQ C30 and STO22 at 3 months postoperatively. The secondary endpoints are QOL at 6 months postoperatively, 12 months postoperative, food intake, body composition, and nutritional indicators from blood test.

\< Patient enrollment\>

* 90 patients in each group, a total of 180 patients
* 1:1 Randomization using permutated mixed block randomization
* stratified by surgical extent (distal gastrectomy vs. total gastrectomy)
* using nQuery program and web-based management system
* Before discharge, patients are informed how to use the smart phone app and registered to the app.
* Patients use the app after discharge until 3 months postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* patient aged 19 or more
* patient diagnosed as stage I in preoperative examination
* planned distal gastrectomy or total gastrectomy
* patient who can use smart phone app or whose family can help the
* patient to use the smart phone app

Exclusion Criteria:

* pregnant
* disabled to communication
* patient who cannot use smart phone app
Mirena® ± Metformin as Fertility-preserving Treatment for Young Asian Women With Early Endometrial Cancer

Primary objective To discover the efficacies of levonorgestrel-containing intrauterine device (LNG-IUS, Mirena®), with or without metformin, as fertility-preserving treatment for grade 1 endometrioid adenocarcinoma of endometrium, cT1aN0M0 with presumed no myometrial invasion on image study (MRI preferred).

Secondary objectives

1. To discover the morphological and molecular change in the endometrium tumor before and after treatment
2. To discover the effectiveness of adding oral progestin to subjects who show no good response to assigned
3. To compare (1) the systemic effects, including body weight change, neuropsychiatric alternation, GI disturbance, skin disorder, change in serum metabolic and hepatic markers between the two study patient groups; (2) The rate of long-term success defined as (a) sustained remission of \>= 12 months starts from the histologic documentation of complete remission (b) rate of pregnancy and (c) alive baby delivery, based on time-to-event analysis.
4. Molecular markers and their expression before, during and after treatment, including progesterone B receptor, progesterone A receptor, estrogen receptor, Ki67, PTEN and its related markers, Bcl2 and its related markers and other developing markers. This is to discover prediction markers to medical treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Women \<= 40 years old with histologic confirmed grade 1 endometrioid adenocarcinoma of the endometrium
2. Tumour is confirmed to the endometrial cavity with no evidence of metastasis on MRI and/or trans-vaginal ultrasonography
3. ECOG 0-1, adequate organ function, with fertility preserving need
4. Immunohistochemical study showed positive progesterone receptor and positive estrogen receptor in the endometrial tumour tissue
5. Serum CA 125 titre is within normal limit
6. Signed informed consent

Exclusion Criteria:

1. Women age \> 40 years or endometrial cancer other than grade 1 endometrioid adenocarcinoma
2. Suspected lymph node metastasis or other metastasis appears in image study
3. Ovarian tumour in image study
4. Blurred junction between the endometrium and the myometrium on image study, with the impression that myometrial invasion of the endometrial tumour cannot be ruled out
5. Ultrasonographic study or MRI show obvious adenomyosis or ovarian endometriosis
6. Women who are contraindicated to receive study treatment because of intolerance to treatment agents, medical co-morbidity or other reason(s)
7. Women with history of or concurrent with malignancy other than skin basal cell carcinoma
8. Women who cannot participate regular follow-up