cyrilzakka/clinical-trials huggingface dataset:
Reduction of Tacrolimus Dose in Association With Mycophenolate Mofetil After Liver Transplantation

The prevention of graft rejection after liver transplantation benefits nowadays from a variety of newly developed immunosuppressive agents. This allows more flexible and individualized immunoprophylaxis and gives an opportunity to reduce the long-term side effects (hypertension, renal failure, diabetes, etc.) of immunosuppression. The purpose of this study is to evaluate, in liver transplanted patients, if low doses of tacrolimus, given in combination with mycophenolate mofetil, can result in a lower rate of long-term side effects without increasing the rate of graft rejection.

Tacrolimus and mycophenolate mofetil are currently approved immunosuppressive agents for the prevention of acute and chronic rejection in liver transplantation. Adverse effects of tacrolimus are dose-dependent and appear early after the onset of treatment. To prevent side effects, we propose to combine reduced doses of tacrolimus with another immunosuppressant, i.e. mycophenolate mofetil, administered at usual doses. This study evaluates the interest of this combination and, subsequently, the pharmacokinetics of mycophenolate mofetil in this therapeutic context. Patients undergoing liver transplantation will be randomized to tacrolimus at normal doses or to the combination of tacrolimus at half doses and mycophenolate mofetil. A corticotherapy will be associated in both groups. The safety will be evaluated on the number of graft rejections between day 1 after transplantation and week 48; the onset of complications (hypertension, renal failure, diabetes, etc.) will allow to evaluate the efficacy of both treatment schedules.

Eligibility Criteria:
Inclusion Criteria:

* Adults over 18 years of age
* Primary liver transplantation
* Immunosuppressive treatment associating tacrolimus and steroids at low doses (\< 20 mg/d)
* Written informed consent

Non-Inclusion Criteria:

* Pregnancy or ineffective contraception
* Immunosuppressive treatment
* Blood group incompatibility with the donor
* Autoimmune hepatitis
* Fulminant hepatitis
* Primary sclerosing cholangitis
* Combined transplantations
* Reduced liver
* Living donor
* Treated hypertension and/or diastolic pressure ≥ 90 mmHg and/or systolic pressure ≥ 140 mmHg,
* Acute or chronic renal failure(creatininemia ≥ 130 μmol/L) before transplantation
* Treated diabetes and/or fasting glycemia ≥ 7 mmol/L
* Treated hypercholesterolemia and/or cholesterolemia ≥ 7 mmol/L
* post-operative creatininemia ≥ 200 μmol/L
LCS16 vs. COC User Satisfaction and Tolerability Study

To evaluate user satisfaction in young nulliparous and parous women (18-29 years of age \[inclusive\]), using LCS16 compared to a COC over a period of 12 months.


Eligibility Criteria:
Inclusion Criteria:

* The subject has signed and dated the Informed Consent Form (ICF).
* The subject is healthy when requesting contraception.
* The subject is between 18 - 29 years of age (inclusive) at the time of signing the ICF.
* The subject has normal or clinically insignificant cervical smear for oncocytology (i.e. Pap test) not requiring further follow up (a cervical smear has to be taken at the Screening Visit \[Visit 1\] or a normal result has to have been documented within the previous 6 months).
* The subject has a history of regular (i.e., endogenous cyclicity without hormonal contraceptive use) cyclic menstrual periods (length of cycle 21 - 35 days), as confirmed by the subject.
* The subject is willing and able to attend the scheduled study visits and to comply with the study procedures.

Exclusion Criteria:

* Pregnancy or current lactation (less than 6 weeks postpartum or since abortion before the Screening Visit)
* Infected abortion or postpartum endometritis within 3 months prior to the Screening Visit.
* Chronic, daily use of drugs that may increase serum potassium levels.
* Undiagnosed abnormal genital bleeding.
* Acute cervicitis or vaginitis (until successfully treated).
* Lower urinary tract infection (until successfully treated).
* Acute or recurrent pelvic inflammatory disease or conditions associated with increased risk for pelvic infections.
* Congenital or acquired uterine anomaly including fibroids, in the opinion of the investigator, which would interfere with insertion and/or retention of the intrauterine system (i.e., if they distort the uterine cavity).
* Cervical neoplasia, uterine or cervical malignancy, or sex hormone-dependent tumors.
* History of migraine, focal migraine with asymmetrical visual loss or other symptoms indicating transient cerebral ischemia.
PD-1 Antibody and Lenvatinib Plus TACE-HAIC for Potential Resectable HCC: a Single-arm, Phase 2 Clinical Trial

Hepatocellular carcinoma (HCC) is one of the most commonly malignant tumors around the world. Hepatic resection or liver transplantation is the radical method to cure the disease. However, less than 20% of newly diagnosed patients can undergo radical resection. Our latest study showed that 48% potentially resectable HCC received hepatectomy after transarterial chemoembolization plus FOLFOX-based chemotherapy infusion (TACE-HAIC) treatment. Recently, several clinical trials (LEAP-002) showed that PD-1 antibody and Lenvatinib had an ORR of 36% for advanced patients. The combination of TACE-HAIC with PD-1 antibody and lenvatinib, theoretically can significantly decrease the tumor burden and increase the hepatectomy rate. However, this hasn't been verified in clinical application. To identify a more effective and safety way for treating potentially resectable HCC patients, this study is designed to investigate TACE-HAIC plus PD-1 antibody and Lenvatinib will increase the resection rate for those patients.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed as potentially resectable with consensus by the panel of liver surgeons
* stage BCLC A/B/C, without extra-hepatic involvement
* No previous anti-HCC treatment
* Eastern Co-operative Group performance status 2 or less
* Liver function: Child's A or B (score \< 7)

Exclusion Criteria:

* Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy

  * underlying serve cardiac or renal diseases Known or suspected allergy to the investigational agent or any agent given in association with this trial
  * Patients ineligible for hepatic artery embolization, or PD-1 antibody
This Trial Will Evaluate the Clinical Performance of Onlay Restorations Fabricated Using Rubber Dam Scanning Techniques.

The purpose of this study will be to evaluate the clinical performance of CAD-CAM onlay restorations fabricated using rubber dam scanning techniques up to 12 months and laboratory investigation of their marginal fit.

A total of 54 molars will be prepared for CAD-CAM onlay restorations. The preparations will be divided into three groups according to the technique of scanning. Group I: 18 preparations will be scanned without rubber dam using standard technique, group II: 18 preparations will be scanned under rubber dam isolation using cut technique, and group III: 18 preparations will be scanned under rubber dam isolation using lock technique. Final restorations will be milled, checked and cemented, then will be evaluated using the modified FDI criteria at baseline, three months, six months, and one year.

Thirty resin dies will be 3D printed after scanning of a first molar tooth prepared for onlay. The dies will be scanned after they fit in a typodont and grouped with the same technique (n=10 per group). The digital scans will be superimposed using a 3D best-fit alignment method and 3D deviation will be calculated for each group itself and to the other groups. The marginal fit of the restorations produced will be checked using two methods: Triple scan and measuring the cement thickness after cementation and sectioning of the samples.

All data will be collected, and statistically analyzed using suitable tests.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy adult patients (18-45 years old).
2. Patients in need of class II (OM or OD) caries in molar teeth with initial, moderate or extensive stage according to the staging of caries lesions in The International Caries Detection and Assessment system (ICDASTM codes 2 to 6) (32,33).
3. Presence of proximal caries in digital x-ray with score 2 to 4 according to the ICDAS/ICCMS™ radiographic scoring system(32,33).
4. Vital teeth with absence of clinical signs and symptoms of periapical pathology.
5. Patient Ability to tolerate Rubber Dam applications.
6. Patients who will agree to attend regular check-ups.

Exclusion Criteria:

1. Bad oral hygiene (Grade 3)(34).
2. Non- vital teeth or endodontically treated teeth.
3. Severe Periodontal problems (pockets ≥6mm).
4. Patients with para-functional habits (e.g., Bruxism, attrition, wear facets)
Efficacy and Safety of JTT-705 300, 600 And 900mg in Comparison With Placebo in Patients With Type II Hyperlipidaemia

To demonstrate the effect of JTT-705 doses from 300 mg to 900 mg on the elevation of HDL-C and on the inhibition of CETP activity versus placebo, in patients presenting with mild dyslipidaemia. These objectives will be tested after 4 weeks of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patients with of Type II hyperlipidaemia
* Patients having lipid values as indicated below:

  * HDL-C \< 1.6 mmol/l
  * TG \< 4.5 mmol/l
* Male and females between 18 and 65 years old (If female must be post-menopausal, or pre-menopausal and surgically sterile or using an acceptable form of contraception)

Exclusion Criteria:

* Body Mass Index (BMI) \> 35 kg/m²
* Pregnant, breast feeding, or woman with child bearing potential without an effective method of contraception
* Concomitant use of medications identified in the protocol
Safety and Efficacy of Adalimumab (Humira) for Hidradenitis Suppurativa (HS) Peri-Surgically

The objective of this study was to assess the safety and efficacy of adalimumab prior to surgery in participants with moderate to severe Hidradenitis Suppurativa (HS) who were surgical candidates.

This was an interventional, randomized, double-blind (DB), placebo-controlled study. The study duration included a 30-day Screening Period, an initial 12-week DB treatment pre-surgery period (Period A), a 2-week peri-operative period with continuation of weekly DB study drug administration (Period B), and a subsequent 10-week DB treatment post-operative period (Period C). Randomization (in a 1:1 ratio) in Period A was stratified by baseline Hurley Stage (II versus III) and anatomical location of the planned surgical site (i.e., axilla versus inguinal region). The projected size of the surgical excision established by the designated surgeon during the Screening Period (calculated from a tracing of the outer perimeter onto an acetate sheet or equivalent) was recorded. In Period B, the designated surgeon measured and recorded the surface area of the actual surgery, with surgery occurring during Week 13. Surgery and post-operative management (e.g., hospitalization, surgical wound care) was per local practice. No study drug was administered at Week 24, the final study visit. Participants were able to begin commercial product (as prescribed by the participants's physician) after all Week 24 procedures were completed.

Eligibility Criteria:
Inclusion Criteria:

* Participant must have skin lesions that are diagnostic of Hidradenitis Suppurativa (HS) for at least 1 year (365 days) prior to the Baseline visit
* Participant must have at least 3 distinct anatomical regions involved with inflammatory (also termed 'active') HS lesions; plus

  * either one axilla or one inguinal region (limited to the inguino-crural fold and adjacent areas) that requires excisional surgery, and
  * with at least one of the other affected HS regions (e.g., contralateral inguinal region, buttocks, inframammary region) rated as Hurley Stage II or III
* Participant must have a total abscess and inflammatory nodule (AN) count of greater than or equal to 3 at the Baseline visit within the HS non-surgical sites
* The HS surgical site must contain at least one active HS lesion
* The HS surgical site must require excisional surgery and is large enough to require healing by secondary intention as assessed by the designated surgeon

Exclusion Criteria:

* Participant has a draining fistula count of greater than 20 at the Baseline visit
* Participant requires surgery at any anatomical site other than an unilateral axilla or inguinal region site
* Participant requires surgical management prior to Week 13
* Participant requires, based on the designated surgeon's assessment, excisional surgery with primary closure as the method of closure being most beneficial for the participant
A Feasibility Study of Adaptive Intensity-Modulated Radiation Therapy

Patients with head and neck cancer and are schedule to receive standard radiation therapy known as IMRT to treat cancer

In this study, we will plan additional measurements of the position of the patient's organs weekly during radiation treatment. We will analyze these measurements in order to evaluate whether we need to adjust our treatment procedures for the remainder of the treatments. We might adjust the dose of radiation received to specific organs in order to try to minimize the amount of radiation the healthy tissue receives.

Eligibility Criteria:
Inclusion Criteria:

* Age \>= 18
* Karnofsky Performance Status of \>= 60
* New diagnosis of head-and-neck cancer, all subsites included (i.e. nasopharynx, oropharynx, oral cavity, hypopharynx, larynx.)
* All stages with measurable gross disease (\>= 1.0 cm) by CT imaging
* Pathologic confirmation of squamous cell carcinoma by biopsy or cytology
* Signed study-specific consent form
* Sequential or concurrent chemotherapy is allowed but not mandated. (no chemotherapy is allowed if patient is judged not to be a candidate for chemotherapy by the medical oncologist)

Exclusion Criteria

* Age \< 18
* Karnofsky Performance Status \< 60
* Radiographic or pathologic evidence of distant metastatic disease (i.e. other than cervical lymph nodes)
* Prior radiation therapy to the head-and-neck region
Lung Cancer Screening Eligibility Assessment

The primary purpose of this study evaluate if different messaging impacts response rates to a brief survey (i.e., the simplified eligibility tool) that is designed to estimate pack-year eligibility for lung cancer screening (LCS). This will help inform the best way to increase response rates to the tool in future intervention studies designed to increase LCS, and expand upon survey methodology in general.

Despite growing evidence that lung cancer screening (LCS) reduces lung cancer-specific mortality, LCS across the United States is remarkably low. This is due in part to challenges with identifying adults who meet eligibility criteria for lifetime smoking intensity (i.e., 20 pack-years or greater), which is often missing from the electronic medical record. We have developed a simplified eligibility tool that has shown accuracy in estimating pack-years. But given the potential for low response rates, there is a great need to identify effective strategies to increasing response rates equitably prior to using it in practice or in future studies. The primary purpose of this study evaluate if different messaging impacts response rates to a brief survey (i.e., the simplified eligibility tool) that is designed to estimate pack-year eligibility for lung cancer screening (LCS). This will help to identify the best way to increase response rates to the tool in future intervention studies designed to increase LCS, and expand upon survey methodology in general.

Eligibility Criteria:
Inclusion Criteria:

1. meet age eligibility (50-80 years old) for LCS based on 2021 USPSTF guidelines; and
2. have completed at least one primary care visit at Penn Medicine in 2020-2025

Exclusion Criteria:

1. have a documented history of lung cancer;
2. have a documented history of completing LCS at Penn Medicine;
3. are listed as not wanting to be contacted or solicited for research; or
4. do not otherwise meet inclusion criteria.
A Study of Intraocular Pressure (IOP) Reduction in Newly Diagnosed Patients With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT)

This is an observational study and will evaluate IOP reduction in newly diagnosed patients with POAG or OHT. All care (including treatment and diagnostic procedures) provided is at the discretion of the participating physicians according to their clinical judgment and the local standard of medical care.


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed with primary open angle glaucoma or ocular hypertension

Exclusion Criteria:

* None
Study of SPARC1103 in Subjects With Spasticity

Study of SPARC1103 in subjects with spasticity


Eligibility Criteria:
Inclusion Criteria:

* Men and women greater than or equal to 18 years of age
* Willing to sign the informed consent form
* Women of child bearing potential willing to practice an acceptable method of birth control
* Known history of spasticity due to MS

Exclusion Criteria:

* Administration of an investigational drug or device within 30 days prior to Screening Visit 1
* Unable to comply with trial procedures in the opinion of the Investigator
* Concomitant neurologic conditions causing spasticity
* Any medical condition, including psychiatric disease or epilepsy, which would interfere with the interpretation of the trial results
Evaluation of Renal Damage After PCNL and ESWL Using Novel RNA Based Biomarkers

The study evaluate the damage effect of ESWL and PCNL on kidney tissue by measuring non-coding lnc-RNA profile in urine before and after ESWL and PCNL procedures

The study evaluate the damage effect of ESWL and PCNL on kidney tissue by measuring non-coding lnc-RNA profile in urine before and after ESWL and PCNL procedures and assess their usefulness as diagnostic biomarkers for AKI and the relationship between the selected RNA based biomarker panel and clinicopathological changes of patients.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria for patients :

  1. Patients undergoing treatment for a stone(s) located in the kidney less than 2 cm
  2. Radiopaque stone
  3. Able and willing to give informed consent

Inclusion criteria for Healthy volunteers

1. No history of kidney or stone disease
2. Asymptomatic
3. No indwelling ureteral stent
4. Willing to provide medical history information
5. Able and willing to give informed consent

Exclusion Criteria:

* Exclusion criteria for patients

  1. Active urinary tract infection
  2. Bleeding disorder
  3. Chronic renal failure (eGFR\<30)
  4. Ureteral stone
Catheter Ablation and Rate Control of Atrial Fibrillation in Patients With Heart Failure

To evaluate the efficacy of catheter ablation and rate control in heart failure patients with atrial fibrillation.

All patients received either catheter ablation for rhythm control or rate control before enrollment, and the investigators do not assign specific interventions to the subjects during the study. So this study might be considered to be observational.

Eligibility Criteria:
Inclusion Criteria:

* age\>18 years
* documented atrial fibrillation
* New York Heart Association Ⅱ-Ⅳ or left ventricular ejection fraction \<50%

Exclusion Criteria:

* heart failure that had a suspected reversible cause
* previous ablation
* any contraindication to catheter ablation
Use of Positive Pressure in Morbidly Obese Patients Undergoing Reduction Stomach Surgery

The aim of this study was to investigate the effects of using positive pressure in the preoperative, intraoperative and postoperative morbidly obese individuals undergoing gastroplasty.

It is believed that the application of these devices before, during or after surgery can help to improve the lungs and reduce pulmonary complications after surgery to reduce the stomach.

The aim of this study was to investigate the effects of using positive pressure in the preoperative, intraoperative and postoperative morbidly obese individuals undergoing Roux-en-Y gastric bypass with regard to: lung volumes and capacities, the prevalence of atelectasis, duration of surgery and diaphragmatic mobility.

Individuals with BMI between 40 and 55 kg/m2, aged between 25 and 55 years, were submitted to Roux-en-Y type gastric bypass by laparotomy. Patients showing a normal preoperative pulmonary function test were included, but those with hemodynamic instability, a hospital stay longer than three days or the presence of postoperative complications were excluded.

The volunteers were divided into four different groups:

Gpre: subjects treated with positive pressure in the BiPAP mode (Bi-Level Positive Airway Pressure) for one hour before surgery; Gpos: individuals treated with positive airway pressure (BiPAP) for one hour after surgery; Gpeep: individuals treated with 10 cm H2O of PEEP (Positive End Expiratory Pressure) during the surgical procedure.

Gcont: individuals treated with conventional physiotherapy (CP) according to the routine service of physiotherapy of the hospital, including the techniques of pulmonary re-expansion, breathing exercises (deep breaths or fractional), the use of incentive spirometry (Respiron®), bronchial hygiene resources if necessary (Flutter® and cough active or assisted) and assisted ambulation. It should be noted that the physiotherapist was blinded to the individual's participation in the groups, and all patients received conventional physiotherapy, independent of the group in which they were included.

The respiratory evaluation (preoperative and second postoperative days) consisted of collecting the anthropometric data, a pulmonary function test and a chest radiography (inspired and expired).

Eligibility Criteria:
Inclusion Criteria:

* BMI between 40 and 55 kg/m2
* Aged between 25 and 55 years
* Submitted to Roux-en-Y type gastric bypass by laparotomy
* Normal preoperative pulmonary function test

Exclusion Criteria:

* Hemodynamic instability
* Hospital stay longer than three days
* Presence of postoperative complications
Dose Ranging Study of Rimegepant (BMS-927711) for the Acute Treatment of Migraine

The primary purpose of this study is to evaluate the efficacy of rimegepant (BMS-927711) compared with placebo in the acute treatment of migraine as measured by Pain Freedom (headache pain intensity level reported as "no pain") at 2 hours post dose using a four point numeric rating scale (no pain, mild pain, moderate pain, severe pain) while identifying an optimal dose to support the Phase 3 clinical trials.

Intervention Model: Parallel Versus Comparator + Placebo

Eligibility Criteria:
Key Inclusion Criteria:

* Patient with at least 1-year history of migraines (with or without aura) including the following:

  * Migraine attacks more than 1 year with age of onset prior to 50 years of age
  * Migraine attacks, on average, last about 4 - 72 hours if untreated
  * No more than 8 attacks of moderate to severe intensity per month within last 3 months
  * Patient must be able to distinguish migraine attacks from tension/cluster attacks and must have consistent migraine headaches of at least 2 migraine headaches attacks of moderate to severe intensity in each of the last 3 months
  * Less than 15 days of headache (migraine or non-migraine) per month in each of 3 months prior to screening
* Male and female ≥ 18 years and ≤ age 65
* No clinically significant abnormality identified on the medical or laboratory evaluation

Key Exclusion Criteria:

* Patient has a history of basilar migraine or hemiplegic migraine
* Patient does not receive migraine relief from triptan migraine treatment
* Medications that may alter the pH of the stomach (acid reducing agents), such as H-2 antagonists, Proton Pump inhibitors (PPI), antacids
* History of ergotamine or triptan intake greater than/equal 10 days per month on a regular basis for greater than 3 months
* History of non-narcotic analgesic intake on greater then/equal 15 days per month for greater than/equal 3 months