cyrilzakka/clinical-trials huggingface dataset:
Dynamic Monitor of Portacaval Pressure Gradient

Portacaval pressure gradient (PPG) plays an important role in prediction the outcomes of cirrhotic patients undergoing TIPS. An PPG over 20 mmHg indicates a high risk of failure to control bleeding or preventing rebleeding, while patients with PPG \<12 mmHg are free from the risk of variceal bleeding. Transjugular intrahepatic portosystemic shunt (TIPS) markedly reduces PPG and is a very effective treatment for portal hypertension. A recent study showed that timing affects measurement of portacaval pressure gradient (PPG) after TIPS placement in patients with portal hypertension. The immediate PPG after TIPS placement cannot predict the long-term prognosis, while PPG measured with the patient on stable clinical conditions correlates with long term PPG and clinical outcomes. However, this finding remain to be validated. Previous studies have demonstrated that the achievement of a hepatic vein pressure gradient \<12 mmHg eliminated the risk of recurrent variceal hemorrhage. Therefore, a post- TIPS PPG \<12 mmHg was initially proposed as a hemodynamic target of TIPS, independent of the indication. It is important to note that most studies on hemodynamic targets were done before the introduction of covered stents and have not been adequately updated since then.Therefore, whether a post-TIPS PPG target \<12 mmHg is the best cutoff for patients receiving a covered stent for the treatment of portal hypertension complications needs confirmation in well-designed studies.This study aims to dynamically monitor the change of PPG after TIPS procedure in patients with portal hypertension, and investigate its prognostic value in predicting patient outcome.


Eligibility Criteria:
Inclusion Criteria:

* Patients with portal hypertensive complications
* Receiving TIPS due to variceal bleeding or refractory ascites
* Successful covered TIPS procedure
* Written informed consent

Exclusion Criteria:

* Lactating or pregnant
* Malignancies
* Uncontrolled infection (\> grade 2)
* Severe cardiac, pulmonary or renal dysfunction
* Previously treated with TIPS
* Previous liver transplantation
* History of spontaneous overt HE or recurrent HE
Therapeutic Drug Monitoring and Pharmacokinetic Compartmental Analysis of Sulpiride After Oral Administration to Healthy Volunteers

The present study was adopted to evaluate the pharmacokinetics of sulpiride after oral administration.

The present study was adopted to evaluate the pharmacokinetics of sulpiride after administration of single oral doses of 50 mg in an open-label, one-way study.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old and not more than 45 healthy male volunteers
* Actual weight no more than ± 30% from ideal body weight based on sex, height, and body frame
* Who had passed all the screening parameters
* Free of any drug exposure known to interfere with the pharmacokinetics or assay of sulpiride for at least 10 days prior to the study
* Who had to be able to communicate effectively with study personnel, be literate, and able to give consent.

Exclusion Criteria:

* A clinically significant abnormal physical exam, medical history, or laboratory studies If they showed a sitting SBP of \>140 or \<100 mmHg, DBP \> 90 or \<60mm Hg, or a pulse rate of \> 95 or \< 50 beats/min at screening A history of serious intolerance, allergy, or sensitivity to fexofenadine The use of any prescription drug within the previous month or use of any over-the-counter medication (with the exception of acetaminophen) within the past 14 days A history of blood dyscrasias A history of alcohol or drug abuse within the past year Donation of blood during the 8 weeks prior to the study or plans to donate blood during or within 8 weeks of completing the study Unable to tolerate vein puncture and multiple blood samplings Any surgical/medical condition that might alter drug absorption, distribution, metabolism, or excretion Cannot follow instructions, in the opinion of the investigator.
Transcervical Myoma Biopsy Video

To describe the fertility-sparing management of an atypical uterine myoma. Step-by-step video explanation of transcervical biopsy using transabdominal ultrasound guidance, highlighting tips and tricks. Patient consent was obtained for publication of the case.


Eligibility Criteria:
Inclusion criteria:

* age \>18 years old
* WOMAN WITH DESIRE FOR PREGNANCY
* ATYPICAL MYOMA

Exclusion criteria:

- age \< 18 years old
The Effect of Accelerated Rehabilitation After Anterior Cruciate Ligament Reconstruction With and Without Suture Tape Reinforcement

The aim of our study is to evaluate the effect of accelerated rehabilitation post ACL reconstruction with and without augmentation on graft healing and return to normal activity clinically by scoring system and radiologically.

ACL reconstruction is the most commonly performed knee ligament reconstruction and employs a variety of surgical techniques. However, despite high success rates, it is still challenged by residual laxity and graft rupture.

While the majority of patients who undergo ACLR will have good to excellent results, a subset of patients is at a higher risk for graft failure. For those that require revision surgery, the second operation often fails. Anterior cruciate ligament injuries account for 50% of knee ligament injuries for high school-aged adults.

The most commonly used autografts for ACLR are the hamstring tendons (HT) and the bone-patellar tendon-bone (BPTB). However, questions remain about how patients with either an HT or a BPTB autograft recover knee muscle strength postoperatively.

To help address and prevent future ACL failures, new repair and reconstruction techniques have been employed that incorporate suture augmentation. The goal of augmentation is to protect the newly repaired or reconstructed ligament during rehabilitation.

Despite advances in anterior cruciate ligament (ACL) reconstruction surgical techniques and rehabilitation, recent studies report that between 20% to 50% of those with ACL reconstruction do not return to the same sports after surgery and 10% to 70% of those who resume preinjury sports participate at a reduced level or with significant functional impairments.

Anecdotal evidence from patient report and clinical observation suggests that an inability to return to sports after ACL reconstruction can be partially attributed to a fear of reinjuring the knee.

Eligibility Criteria:
Inclusion Criteria:

* Age from 15 to 50 years old.
* With or without meniscal injury.
* Isolated ACL injury without any other ligament injury.
* Recent and chronic injury.

Exclusion Criteria:

* Multiligament injury.
* Deformed knee (Genu varus or valgus).
* Previous ACL reconstruction or repair.
* Older than 50 years old and younger than 15 years old.
* Failed ACL reconstruction or repair -
Evaluation of Zinc in Patients With Type 2 Diabetes

investigation of the impact of zinc level on the development of DM and to elaborate on whether daily consumption of zinc affects the disease's evolution.

The relationship between the pathophysiology of diabetes mellitus and trace element dysregulation emphasizes how crucial it is to maintain appropriate micronutrient status in order to manage this chronic metabolic disease. One promising strategy for enhancing glycemic control and lowering the risk of diabetic complications may be to address these underlying dietary imbalances.

Accordingly, the aim is to investigate the impact of zinc level on the development of DM and to elaborate on whether daily consumption of zinc affects the disease's evolution.

Eligibility Criteria:
Inclusion Criteria:

* confirmed Type 2 DM with no known complication
* more than or equal 40 years old

Exclusion Criteria:

pregnancy and lactation type 1DM known DM complication other endocrinological disorders malignancy
A Trial of SHR-A1912 Combined With Other Therapies in B-cell Non-Hodgkin 's Lymphoma

This study aims to evaluate the safety, PK and preliminary anti-tumour activity of SHR-A1912 combined with other therapies in patients with B-cell non-Hodgkin 's lymphoma.


Eligibility Criteria:
Inclusion Criteria:

1. Age greater than or equal to18 years old;
2. Eastern Cooperative Oncology Group (ECOG) performance status is 0 to 1;
3. Life expectancy \>3 months;
4. Histologically confirmed B-cell B-cell non-Hodgkin's lymphoma;
5. Previous systematic anti-tumor therapy should meet the following requirements: 1) Relapsed and/or refractory disease after at least one (≥ 1) line of prior systemic therapy (relapsed/refractory cohort); 2) Previously untreated (naïve cohort).
6. At least one measurable nodal lesion, defined as \> 1.5 cm in its longest dimension, or one measurable extra nodal lesion, defined as \> 1.0 cm in its longest diameter.

Exclusion Criteria:

1. Received autologous stem cell transplantation within 12 weeks before the first study treatment; previously received allogeneic stem cell transplantation; received Car-T cell therapy within 12 weeks before the first study treatment;
2. History of recent major surgery or severe trauma within 4 weeks before the first study treatment;
3. Received anti-tumour treatment within 2 weeks before the first study treatment;
4. Central nervous system (CNS) infiltration;
5. Active infection with HBV or HCV;
6. History of immunodeficiency, including HIV serotest positive, or other acquired or congenital immunodeficiency diseases, and active tuberculosis;
7. Active infection or unexplained fever\>38.5℃;
8. History of severe cardiovascular disease.
Impact of Different Treatment in Multivessel Non ST Elevation Myocardial Infarction (NSTEMI) Patients: One Stage Versus Multistaged Percutaneous Coronary Intervention (PCI)

Patients with NSTEMI and multivessel disease will be scheduled to undergo early invasive strategy (PCI within 72 hours) of de novo native coronary artery lesions were considered for recruitment into the study. Inclusion criteria are the following: diagnosis of NSTEMI according to current guidelines presenting with multivessel disease. We will exclude patients with cardiogenic shock at presentation (systolic blood pressure \<90 mmHg despite drug therapy), left main coronary disease (\>50% diameter stenosis), previous coronary artery bypass grafting (CABG) surgery, patients with Syntax Score \>32 and candidated to by-pass surgery (10), severe valvular heart disease and unsuccessful procedures. Procedure success was defined as the achievement of an angiographic residual stenosis of less than 30% and a thrombolysis in myocardial infarction (TIMI) flow grade III after PCI.

Patients randomized to One-Stage group were completely revascularizated in one time PCI, whereas patients randomized to Multi-Staged group were completely revascularizated in more time PCI, during the same hospitalization. Patients received a clopidogrel loading dose of 600 mg before the PCI (for loading dose administered more than 6 h prior to procedure). Post-procedural antiplatelet regimen consisted of aspirin at 100 mg/day indefinitely and clopidogrel 75 mg/day for at least one month.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of NSTEMI
* presenting with multivessel disease

Exclusion Criteria:

* patients with cardiogenic shock at presentation
* left main coronary disease (\>50% diameter stenosis)
* previous coronary artery bypass grafting (CABG) surgery
* patients with Syntax Score \>32
* candidated to by-pass surgery
* severe valvular heart disease
* unsuccessful procedures
RCT Comparing OAGB and Long Limb Roux Gastric Bypass

A prospective multicenter randomized controlled trial to compare the outcomes of one-anastomosis gastric bypass to long biliary limb Roux gastric bypass.

We plan to enroll up to 500 patients from three different clinics in Estonia. Outcomes are excess weight loss %, impact on type 2 diabetes, hypertension, hyperlipidemia and obstructive sleep apnea.

Other outcomes are nutritional deficiencies, occurrence of reflux disease and impact on quality of life.

There are planned outpatient visits 1, 5 and 10 years after the surgery to measure the impacts.

There are a lot of studies comparing OAGB to standard Roux gastric bypass but non comparing it to long biliary limb gastric bypass.


Eligibility Criteria:
Inclusion Criteria:

* BMI over 35 and obesity related disease
* BMI over 40
* age between 18-60 years
* agrees to participate in the study

Exclusion Criteria:

* age under 18 years or over 60 years
* abundant adhesions discovered during the surgery
* active upper gastrointestinal ulcer disease
* prior bariatric surgery
* active symptomatic reflux disease
* active psychiatric disease (eg psychosis)
Effectivity and Safety of PFO Closure Vs Medicine in Alleviating Migraine

Effectivity and safety of PFO closure vs medicine in alleviating migraine （SPRING）: a multicenter, random, case control study


Eligibility Criteria:
Inclusion Criteria:

1. Presence of PFO with right-to-left shunt, confirmed by Transthoracic.
2. Echocardiography (TTE) or transesophageal echocardiography (TEE) with a bubble study.
3. Bubble study positive confirmed by transcranial doppler.
4. Subject is diagnosed of migraine.
5. Subject signs an informed Consent Form and is willing to participate in follow-up visits

Exclusion Criteria:

1. Subject is diagnosed of headache with clear etiology.
2. Subject had cerebral hemorrhage, bleeding events in other organs within 3 months or was in high risk of bleeding.
3. Brain CT/MR showed ischemic lesions.
4. Subject is diagnosed of hepatic insufficiency: ALT or AST\>3×ULN at the screening visit.
5. Subject is diagnosed of moderate to severe renal insufficiency: eGFR\<30ml/min/1.73m2 at the screening visit.
6. Subject has uncontrolled arrhythmia with clinical significance within 90 days.
7. Subject is diagnosed of unstable angina, severe coronary atherosclerosis or myocardial infarction within 90 days.
8. Subject is diagnosed of pulmonary artery embolism, peripheral artery embolism or deep Vein Thrombosis.
9. Subject cannot follow the study procedure due to other acute or chronic diseases.
10. Subject is pregnant or lactating.
11. Subject is under other RCT.
12. Subject has a life expectancy \<1 year.
13. Subject cannot follow the study procedure due to other reasons in the opinion of the investigators.
Is IFN-beta Treatment in MS Useful After a Washout Period in Patients With Neutralizing Antibodies to Interferon Beta

This study is to find out if Interferon-beta (IFN-beta) can recover its effectiveness after a washout period in patients with Multiple Sclerosis who have previously developed neutralizing antibodies to Interferon-Beta

This is an explorative multi-centre, open label, non-comparative trial investigating whether it is possible to recover IFN-beta efficacy in breakthrough relapsing-remitting multiple sclerosis patients with high titres of neutralizing IFN-beta antibodies.

Prior to enrollment, treated MS subjects must have been on interferon-beta-1a or interferon-beta-1b for a minimum of 12 months and have reduced bioavailability as defined by the relative expression of MxA mRNA/GAPDH.

Subjects will complete a washout period with concurrent methylprednisolone 500mg PO daily for 3 days every month until they become Neutralizing Antibody negative. Subjects will then be challenged with AVONEX 30mcg IM weekly. Bioavailability will be measured every three months to determine return of biological activity. Clinical and MRI parameters, safety and tolerability will be compared to baseline to determine efficacy.

Eligibility Criteria:
Inclusion Criteria:

* Must have been receiving interferon-beta-1a or interferon-beta-1b for a minimum of 12 consecutive months prior to enrollment
* Relapsing-Remitting Multiple Sclerosis according to Poser or McDonald criteria
* EDSS score of 6 or less
* NAB titre \>or equal to 20 via CPE assay or \>or equal to 100 via MxA Protein assay measured at least 24 hours after last interferon-beta injection on two consecutive tests at least 3 months apart
* Reduced bioavailability (relative expression of MxA mRNA/GAPDH

Exclusion Criteria:

* History of severe allergic or anaphylactic reaction to human albumin, to any interferon, Methylprednisolone or to any other component of study drugs
* Clinically significant systemic illness
* History of poorly controlled hypertension, diabetes, or osteoporosis
* History of uncontrolled seizures within 3 months of enrollment
* History of Depression or suicidal ideation within 3 months of enrollment
* Serious local infection (abscess or cellulitis) or systemic infection within 8 weeks of study
* abnormal screening blood tests
Fallopian Tube Removal as a Method of Ovarian Cancer Prevention: A Descriptive Study

The purpose of this study is to better understand why women choose to have their fallopian tubes removed as a method for ovarian cancer prevention. This will be done through a paper questionnaire and phone interviews. The investigators hope to gain information that will allow us to better counsel women about ovarian cancer prevention.

Women will be found eligible for this study after an eligibility questionnaire given over the phone. If one is found eligible, she will be sent a consent and paper survey to fill out and send back to the research coordinator. Once that is completed, she will be given a phone interview in order answer additional questions of interest. Lastly, the study participant will be contacted once a year over the phone to obtain follow-up information.

Eligibility Criteria:
Inclusion Criteria:

* Female of at least 18 years of age
* Must speak English fluently
* Have had fallopian tubes removed as a method of ovarian cancer prevention

Exclusion Criteria:

* Males
* Females under the age of 18
Cerebrolysin REGistry Study in Stroke - a High-quality Observational Study of Comparative Effectiveness

This study investigates the clinical practices, safety and effectiveness of Cerebrolysin in routine treatment of patients with moderate to severe neurological deficits after acute ischemic stroke.

Patients registered: Acute Ischemic Stroke patients with moderate to severe neurological deficits

All patients receive acute stroke care according to local treatment standards, not amended or influenced by the study:

Cerebrolysin Group:

Patients who are treated with Cerebrolysin; dosage, frequency and duration follows local clinical practice in accordance with terms of the local marketing authorization

Control group:

Patients who are not treated with Cerebrolysin

Observation criteria:

* Signed Informed Consent
* Clinical diagnosis of acute ischemic stroke confirmed by imaging
* Moderate to severe neurological deficits with NIH Stroke Scale (NIHSS) 8 to 15, both inclusive
* No prior stroke
* No prior disability
* Patient's independence prior to stroke onset (pre-morbid mRS of 0 or 1)
* Reasonable expectation of successful follow-up (max. 100 days)

The study follows the recommendations of the Principles for Good Research on Comparative Effectiveness (GRACE).

In order to comply with recent calls for high-quality non-interventional comparative effectiveness research, a risk-based centralized statistical approach to monitoring is introduced in combination with targeted on-site monitoring for ongoing surveillance of study conduct, thus ensuring highest standards of data quality and integrity according to the most recent requirements of the ICH E6 Guideline for Good Clinical Practice (GCP, Amendment R2, July 2015), the FDA Guidance for Industry on a Risk-based Approach to Monitoring, and the EMA reflection-paper on risk-based quality management in clinical trials.

Eligibility Criteria:
Inclusion Criteria:

* Signed Informed Consent
* Clinical diagnosis of acute ischemic stroke confirmed by imaging
* Moderate to severe neurological deficits with NIH Stroke Scale (NIHSS) 8 to 15, both inclusive
* No prior stroke
* No prior disability
* Patient's independence prior to stroke onset (pre-morbid mRS of 0 or 1)
* Reasonable expectation of successful follow-up (max. 100 days)

Exclusion Criteria:

* none
Locally Delivered Aloe Vera Gel in the Treatment of Chronic Periodontitis Patients With Diabetes Mellitus

A study on the effect of locally delivered aloe vera gel as an adjunct to scaling and root planing in the treatment of chronic periodontitis patients with controlled type II diabetes mellitus.The evaluation of Plaque Index, Gingival Index, Probing Pocket Depth, Relative Attachment Level at baseline, 6 weeks and 3 months and Glycosylated heamoglobin at baseline and 3 months.

Aloe vera gel was locally delivered in the periodontal pockets of ≥ 5mm bilaterally in chronic periodontitis patients with diabetes under control.(HbA1c-6.6-8.6%).The study design had two groups-one in which scaling and root planing and local delivery of aloe vera gel and the other only scaling and root planing.

The evaluation of clinical parameters of PI, GI, PPD and RAL at baseline, 6 weeks and 3 months.

HbA1c evaluated at baseline and 3 months.

Eligibility Criteria:
Inclusion Criteria:

1. Patients age 30 - 55 years from both genders.
2. Patients with controlled Type II Diabetes Mellitus (HbA1c \< 7%) with Chronic periodontitis having ≥ 5mm periodontal pockets bilaterally atleast in one site.
3. Patients on oral hypoglycaemic agents.
4. Subjects who have not received periodontal therapy within preceding 6 months.
5. Patients willing to comply with all study related procedures.

Exclusion Criteria:

1. Subjects who have received antibiotic treatment in the preceding 3 months.
2. History of prolonged use of antibiotics/ steroids/ immunosuppressive agents /aspirin/ anticoagulants/ other medications including any other herbal products.
3. Pregnant or lactating women.
4. Smokers.
5. History of systemic diseases like hypertension, HIV, bone metabolic disorders, radiation therapy, Osteoporosis, immunosuppressive therapy, cancer etc.other than Diabetes.
6. Unwilling patients