cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of Continuous Infusion of Terlipressin vs Bolus Terlipressin in ACLF Patients With Acute Esophageal Variceal Bleed

Acute portal hypertension, as measured by rapid rise in hepatic venous pressure gradient (HVPG) can lead to further dreaded complications, including acute variceal bleeding (AVB) AVB: 6-week mortality rates of around 15-20% in patients with chronic liver disease without ACLF.The overall prevalence of UGH in cirrhotic patients with AD was 34.4% and 35.7% in patients with ACLF.AVB is a well-recognized precipitant leading to the occurrence and development of ACLF. AVB is a well-recognized precipitant leading to the occurrence and development of ACLF. Medical therapy for esophageal variceal bleeding (EVB) aims to reduce the splanchnic blood flow and portal pressure. The most common vasoactive agents include terlipressin, vasopressin, somatostatin, and octreotide.

Aim and Objective - To assess the safety and efficacy of continuous terlipressin vs. Bolus terlipressin in the management of acute esophageal variceal bleeding in ACLF.

Study population: Adult patients (age ≥ 18 years) diagnosed with ACLF presenting with upper GI bleeding due to esophageal varices Study design: Pilot study Study period: 1 year Sample size: 60

Intervention:

Group I- Intravenous terlipressin (administered as a continuous infusion at 4 mg/24 hours). After 12 hours, if the hepatic venous pressure gradient (HVPG) does not show a reduction of less than 10%, increase the dose to 6 mg/24 hours.

Group II- Intravenous terlipressin (2 mg initially every 4 hourly for 2 days and then 1 mg every 4 hrs)

Monitoring and assessment: All patients would undergo vital and baseline parameter screening before randomization. Based on randomization they will receive either steroid or plasma exchange followed by steroid

Adverse effects:

Acute Diarrhea, chest pain, Arterial hypertension, Cardiac arrhythmias, Acute abdomen Stopping rule: chest pain, alteration of ECG, cyanosis, bradycardia, severe allergic rashes

Eligibility Criteria:
Inclusion Criteria:

1. Adult patients (age ≥ 18 years) diagnosed with ACLF presenting with due to esophageal varices bleeding.

Exclusion Criteria:

1. Age \< 18 years
2. History of coronary heart disease or ventricular arrhythmia,
3. Stroke or transient ischemic attack,
4. Bronchial asthma,
5. Epilepsy,
6. Pregnancy,
7. Rebleeding.
8. HCC
9. Gastric variceal bleed
Muscular Changes in the First 12 Weeks After Stroke.

The investigators will use 3D freehand ultrasound to investigate changes in muscle morphology of the paretic m. rectus femoris and m. gastrocnemius medialis during the first 3 months after stroke. Additionally, 2D ultrasound and surface EMG will be synchronized to examine muscle activation and morphological changes resulting from this activation. Clinical tests will be conducted on the same test occasions to objectify lower limb impairment and gait recovery. As such, the investigators will explore the relationship between the muscle specific changes and functional recovery.

During this longitudinal study, patients who suffer their first-ever stroke will be included within the first week after their stroke (if the inclusion criteria are met). Thereafter, each participant will be assessed at four pre-determined time-points: week 1, 5, 8 and 12 after stroke.

On each of the four time-points, the investigators will assess muscle specific parameters of the affected m. rectus femoris (RF) and m. gastrocnemius medialis (GM), together with clinical tests to assess lower limb impairment (Fugl-Meyer Assessment for the lower limb and the Tardieu scale) and gait parameters (10-meter walk test). Specifically, muscle specific parameters will be investigated using 3D freehand ultrasound (3DfUS) and combined dynamic 2D US and surface electromyography (sEMG). Such assessments will help us characterize the electromechanical properties of these muscles, their time-related trajectories and the relationship with the recovery of gait and lower limb function after stroke. At the end of the investigation period, after 3 months, patients who can walk independently will perform a 3D gait analysis. As such, the relationship between changes in muscle specific parameters and the eventual gait quality at the end of the investigation period will be investigated.

Eligibility Criteria:
Inclusion Criteria:

* Adults (≥ 18 years old)
* Diagnosed with a first-ever stroke (as defined by WHO)
* Stroke onset ≤ 1 week (± 3 days)
* Able to provide written or verbal informed consent at admission
* Presence of gait problems as a consequence of the stroke (FAC≤4)

Exclusion Criteria:

* Presence of other neurological or orthopedic problems present prior to, or not caused as a direct consequence of, the stroke leading to impaired gait.
* Modified Ranking scale pre-stroke \> 1/6, meaning presence of slight disability before the stroke.
* Presence of severe comorbidities (e.g. osteoporosis, cardiovascular instability or chronic obstructive pulmonary disease).
* Cerebellar or bilateral stroke.
* Presence of severe deficits in communication, memory or understanding precluding informed consent.
Comparison of Levobupivacaine, Ropivacaine and Bupivacaine in Epidural Anaesthesia

This study compares the clinical efficacy of newer local anaesthetic drugs Levobupivacaine and Ropivacaine with Bupivacaine in lumbar epidural anaesthesia for hip surgeries.

Some of the most common day care surgeries are hip surgeries, in which local anaesthetic agents can be used via epidural route for both intra-op and post-op analgesia.

Among the drugs used nowadays are Lignocaine, Bupivacaine, Levobupivacaine and Ropivacaine.However Bupivacaine usage is not free from side effects.

The claimed benefits of both Levobupivacaine and Ropivacaine are reduced cardiac toxicity on overdose and more specific effects on sensory rather than motor nerve fibres.

Ropivacaine, an analog of Mepivacaine, is one of the long acting amide anaesthetic agent similar to Bupivacaine in chemical structure and anaesthetic function. It is a first enantiomer-specific compound, which has a reduced risk of cardio toxicity, neuro toxicity and rapid recovery of motor function. Levobupivacaine is the pure S (-)-enantiomer of Bupivacaine, and in recent year has emerged as a safer alternative for regional anaesthesia than its racemic parent.

Eligibility Criteria:
Inclusion Criteria:

* ASA Grade I and II patients of either sex
* Age 18-60 years
* Undergoing various hip surgeries under lumbar epidural anesthesia

Exclusion Criteria:

* Refusal for epidural
* ASA-III\&IV
* Head injury
* Psychiatric disease
* Known allergic to test drugs
* Major systemic disease
* Any analgesia with in past 24 hours
Radiation Therapy or No Further Treatment Following Surgery in Treating Patients With Cancer of the Uterus

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether receiving radiation therapy or no further therapy after surgery is more effective for cancer of the uterus.

PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with that of no further therapy in treating patients who have stage I or stage II cancer of the uterus that has been surgically removed.

OBJECTIVES: I. Compare the rates of pelvic recurrence and development of distant metastases in patients with completely resected, stage I or II, high-grade uterine sarcoma treated with adjuvant pelvic radiotherapy vs observation alone.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center, tumor histology (leiomyosarcoma vs mixed mesodermal sarcoma vs endometrial stromal sarcoma), and surgical procedure (total abdominal hysterectomy (TAH) with or without bilateral salpingo-oophorectomy (BSO) vs TAH and BSO with pelvic and para-aortic node sampling and random biopsies). Patients are randomized to 1 of 2 treatment arms. Arm I: Beginning within 6 weeks after surgery, patients undergo pelvic radiotherapy 5 days a week for 5.6 weeks. Arm II: Patients undergo observation alone. Patients are followed every 2 months for 1 year, every 3 months for 2 years, and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 200 patients (100 per arm) will be accrued for this study within 3 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically proven high-grade uterine sarcoma Eligible subtypes: Leiomyosarcoma Mixed mesodermal (mullerian) sarcoma Endometrial sarcoma Surgically proven stage I or II (T1-2, N0, M0) disease No leiomyoma with a high mitotic activity index after hormonal therapy (especially estrogen) Mixoid leiomyosarcoma with a low mitotic activity index allowed Completely resected disease Prior abdominal hysterectomy as minimal surgical procedure required

PATIENT CHARACTERISTICS: Age: Any age Performance status: WHO 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No other prior malignancy except basal cell skin cancer or carcinoma in situ of the cervix No serious mental disorder

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: See Disease Characteristics Radiotherapy: No prior radiotherapy Surgery: See Disease Characteristics
Pyrexia Management Using an IL-6 Antibody in BRAF+ Melanoma Patients Treated with Dabrafenib/ Trametinib +/- Immunotherapy

The study examines the development of fever after administration of Actemra (tocilizumab) in patients who have fever and other cytokine release symptoms (headache, nausea, palpitations, low blood pressure) due to cancer therapy (Tafinlar (dabrafenib) / Mekinist (trametinib) +/- immunotherapy) . The goal of the study is to better understand the side effects and to find an effective therapy against them.


Eligibility Criteria:
Inclusion Criteria:

1. Informed Consent as documented by signature
2. Subjects (males and females) age ≥ 18 years
3. ECOG \< 3
4. Subjects with pyrexia grade 1\*- 4 and elevated CRP with persistent fever after one day of antipyretic therapy with or without at least one other additional symptom of cytokine release syndrome such as nausea, headache, tachycardia, hypotension, maculopapular rash, shortness of breath, transaminitis, renal failure, dehydration
5. Elevated CRP serum levels further than normal baseline levels (\> 3.0 mg/L)
6. Subjects with resected, non-resectable, adjuvant or metastatic BRAF+ melanoma treated with :

   * BRAF inhibitor (dabrafenib) in combination with MEK inhibitor (trametinib)
   * BRAF inhibitor (dabrafenib) in combination with MEK inhibitor (trametinib) preceded by therapy with anti-PD-1/PD-L1 and/or anti CTLA-4 inhibitor
   * BRAF inhibitor (dabrafenib) in combination with MEK inhibitor (trametinib) plus anti-PD- 1/PD-L1 inhibitor
Reducing Lung CongestIon Symptoms in Advanced Heart Failure

The objective of the RELIEVE-HF study is to provide reasonable assurance of safety and effectiveness of the V-Wave Interatrial Shunt System by improving meaningful clinical outcomes in patients with New York Heart Association (NYHA) functional Class II, Class III, or ambulatory Class IV heart failure (HF), irrespective of left ventricular ejection fraction, who at baseline are treated with guideline-directed drug and device therapies.

This is a prospective, multi-center, 1:1 randomized, patient and observer blinded clinical study, with a Shunt Treatment arm and a non-implant Control arm. A total of approximately 500 patients will be randomized. Patients and all research staff managing the patients after randomization will be blinded during follow-up for a minimum of 12 months to a maximum of 24 months. Control patients will have the opportunity to receive a shunt after 24 months once unblinding occurs, if they provide consent, and continue to meet inclusion/exclusion criteria. All implanted patients will be followed for a total of 5 years from the time of the study device implantation.

Eligibility Criteria:
Main Inclusion Criteria:

* Both heart failure with reduced ejection fraction (HFrEF) and heart failure with preserved ejection fraction (HFpEF) patients
* NYHA Class II, Class III, or ambulatory Class IV HF
* Receiving guideline directed medical and device therapy (GDMT) for heart failure
* For NYHA Class III and ambulatory Class IV, at least one prior hospitalization for heart failure within the last year or elevated BNP level of at least 300 pg/ml or NT-proBNP level of at least 1,500 pg/ml. BNP/NT-ProBNP levels corrected for BMI
* For NYHA Class II, must have both hospitalization and elevated BNP levels as above specifications

Main Exclusion Criteria:

* Systolic blood pressure \<90 or \>160 mmHg
* Presence of Intracardiac thrombus
* Pulmonary hypertension with PASP of ≥70 mm/Hg or PVR \> 4 WU
* Significant RV dysfunction - TAPSE \<12mm or RVFAC ≤25%
* Left Ventricular End-Diastolic Diameter (LVEDD) \>8cm
* Moderate to severe aortic or mitral stenosis
* Stroke or TIA or DVT within the last 6 months
* eGFR \<25 ml/min/1.73 m\^2
* Anatomical anomaly on TEE or ICE that precludes implantation of Shunt across fossa ovalis (FO) of the interatrial septum
* Inadequate vascular access for implantation of shunt, e.g. femoral venous access for transseptal catheterization and inferior vena cava (IVC) is not patent
* Hemodynamic heart rhythm, or respiratory instability at time of Final Exclusion Criteria
Safety, Blood Levels and Effects of AUT00201

The study medicine is a potential future treatment for schizophrenia, an illness that affects the way that people think, feel or behave. It is not clear what causes schizophrenia, but it's been linked to chemical imbalance in the brain. It is hoped that the study medicine will activate specific sites in the brain to help correct that imbalance. Current treatments for schizophrenia don't work very well and can cause unpleasant side effects. It is hoped that the study medicine will work better, and have fewer side effects than existing medicines.

In this 2 part study (Part A: up to 40 healthy male subjects and up to 8 healthy female subjects, Part B: up to 32 healthy male subjects) the primary aim is to assess how safe the study medicine is in healthy men and women.

This study will be in 2 parts, as follows:

Part A will assess single doses of AUT00201 and Part B will assess multiple doses. Part A will be divided into 3 sub-parts: Part A1 will assess single ascending doses in healthy men, Part A2 will assess single ascending doses in healthy women, and Part A3 will assess the effect of food on the PK of AUT00201 in healthy men.

A pharmaceutical company, Autifony Therapeutics Limited, is funding the study. The study will take place at 1 centre in London.


Eligibility Criteria:
Inclusion Criteria:

* Normotensive male (all groups except Part A2) or female (Part A2 only) volunteers
* Must have body mass index (BMI) of 18.0-31.0 kg/m2
* Must be healthy based on clinical history, physical examination, ECG, vital signs, and laboratory tests of blood and urine
* Must be able to give fully informed written consent.

Exclusion Criteria:

History or presence of

* Epilepsy
* Severe head injury, or any other chronic neurological condition or any psychiatric disorder
* Abnormal screening EEG (Part A1 and Part B only)
* Positive tests for hepatitis B \& C, HIV
* Severe adverse reaction to any drug
* Sensitivity to trial medication
* Drug or alcohol abuse
* Use of over-the-counter medication within previous 7 days (with the exception of Paracetamol \[acetaminophen\])
* Prescribed medication during previous 28 days
* Participation in other clinical trials of unlicensed medicines
* Loss of more than 400 mL blood, within the previous 3 months
* Vital signs or QTcF interval outside the acceptable range
* Clinically relevant abnormal findings at the screening assessment
* Acute or chronic illness
* Clinically relevant abnormal medical history or concurrent medical condition
* Positive result for suicidal ideation or behaviour using the Colombia suicide severity rating scale (C-SSRS)
* Possibility that volunteer will not cooperate
* Pre-menopausal females who are pregnant or lactating, or who are sexually active and not using a reliable method of contraception
Prevalence of Hepatitis B Infection in the Galilee Region, Israel

Primary Aims:

1. Evaluate HBV (Hepatitis B Virus) infection prevalence among Druze in the Galilee.
2. Educate the population in order to reduce transmission
3. Increase awareness among primary care providers

Secondary Aims:

1. Identify chronic HBV infected patients who need to be followed and treated,
2. Identify HBV infected women in a childbearing age
3. Identify non immunized individuals and recommend vaccination
4. Identify previously vaccinated individuals who are not immunized
5. Identify previously vaccinated individuals who became infected

Study Design:

Study population is targeted to native Israeli Druze. We aim for evaluating up to 20,000 people from Druze communities in the Galilee area

This work will be divided into three sections:

1. Increasing awareness: lectures and local events will be taken place in the communities. Written information will be given and primary care-providers mainly family doctors, nurses and obstetric surgeons will be involved.
2. All participants, upon signing a consent will:

   * Fill up a questioner
   * Checked for weight, height and waist circumflex
   * Have a blood sample taken
3. Results and recommendations will be forwarded to all participants


Eligibility Criteria:
Inclusion Criteria:

* All consent adults who are 18 year old or older

Exclusion Criteria:

* Individuals younger than 18 year old
* Individuals who cannot or will not sign consent
Facilitating Aftercare for Alcohol Detox Patients

The purpose of this study is to determine whether peer visits (known as "12th Step Calls") and professional counselors (using "Motivational Enhancement Therapy") are effective helping alcoholics link to substance abuse treatment programs after being in the hospital for detox.

For those with an alcohol use disorder, the decision to seek detoxification treatment often represents a desire or willingness to change drinking behavior. This gives clinicians with the opportunity to intervene and improve the lives of these individuals. Even patients admitted involuntarily or who have been coerced may be amenable to change. Therefore, inpatient alcohol detoxification treatment offers an opportunity to prepare these patients for and link them with aftercare treatment.

Unfortunately, clinicians have little to guide them on how the current standard of care for alcohol detoxification might be improved. Improvement in clinical practice is ideally driven by clinical research, but there is little recent published information to guide the development of evidence-based pharmacological or psychological practices or interventions in detoxification settings. As a result, alcohol detoxification treatment has changed little over the past 25 years.

Taken as a whole, the literature suggests that the outcomes of inpatient detoxification are less than optimal. A limited number of published studies suggest that a majority of these patients are not linked to any aftercare following inpatient detoxification treatment and return to drinking within a few weeks of hospital discharge. However, there is some evidence to suggest that interventions, performed while the patient is hospitalized, could encourage patients to initiate involvement in aftercare (i.e., professional treatment and/or mutual self-help following hospitalization) and to decrease drinking or initiate abstinence. Motivational Enhancement Therapy and Twelve-Step Facilitation are two interventions that show promise.

The study proposed in this study addresses this issue by testing two brief interventions, Motivation Enhancement Therapy (MET) and Peer-Twelve Step Facilitation (P-TSF, also known as "12th Step Calls"), which have shown potential to enhance initiation of a period of abstinence and engagement in treatment and/or self-help programs among alcohol detoxification patients.

Eligibility Criteria:
Inclusion Criteria:

* Male and female inpatients 18 years of age or older.
* Participants will have a current DSM-IV diagnosis of alcohol abuse or dependence.
* Able to understand/speak English
* Participants will have signed a witnessed informed consent.

Exclusion Criteria:

* Cognitive impairment (e.g., mental retardation)
* Participants who meet current DSM-IV criteria for bipolar disorder, schizophrenia, or dementia
* Participants who are homeless, without contact person
* Participants enrolled in a methadone maintenance treatment program.
Surgical Treatment of DDH With and Without Capsulorrhaphy

The goal of this interventional study is to evaluates the surgical treatment outcomes of Developmental Dysplasia of Hip with and without capsulorrhaphy between 1-6 years of age . it compares the effectiveness of these approaches in improving postoperative stability , range of motion , and long-term success rates for DDH patients undergoing surgery .:


Eligibility Criteria:
Inclusion Criteria:

1. age: from 1 year to 6 years
2. sex: males and females
3. Children who received no operative treatment before.

Exclusion Criteria:

1. Children who were treated operatively before presentation.
2. Children who had teratologic, post septic or neuromuscular hip dislocation.
Phase 1 Study of KH607 Tablets

This study was a single-center, randomized, double-blind, placebo-controlled study divided into a Single Ascending Dose (SAD) stage and a Multiple Ascending Dose (MAD) stage. The primary objective was to evaluate the safety and tolerability of KH607 tablets in Chinese healthy volunteers.

This study consists of two parts: Part 1-SAD phase and Part 2- MAD phase. There will be eight cohorts in Part 1 and three cohorts in Part 2 of this study.

The SAD study will enroll approximately 58 HVs across 8 dose cohorts. The dose cohorts will include the following dose levels: 2 mg, 5 mg, 10 mg, 20 mg, 30 mg, 40 mg, 50mg and 60 mg. All participants in Part 1 will be administered with a single oral dose of KH607 or its matching placebo under fasted condition.

Approximately 30 HVs will be enrolled in the multiple ascending dose study. The dose cohorts will include the following dose levels: 10 mg, 20 mg, 30 mg.At each cohort, 10 subjects will be randomized in a ratio of 8:2 to be receive KH607 or placebo once daily for continuous 7 days (QDx7d) in a double-blind manner.

Additionally, this study will explore the effect of food on the PK of a single oral administration of KH607 in one selected SAD cohort.

Eligibility Criteria:
Inclusion Criteria:

1. Adult, male and female volunteers, 18 to 55 years of age, inclusive.
2. Male weight ≥ 50kg, female weight ≥ 45kg, and body mass index ≥ 19 to ≤ 28 kg/m2 at the screening period.

Exclusion Criteria:

1. Vulnerable groups include the Investigator and his or her immediate family members (spouse, parents, children, siblings), non-immediate family members involved in the study, or individuals who may be participating under coercion or undue influence.
2. Subjects whose C-SSRS suggests that they are at risk for suicide at the screening period, or with the risk for suicide based on the Investigator's clinical judgment, or with a history of suicidal or self-harming behavior.
3. Subjects with SSS ≥3 or MOAA/S ≤4 during the screening period.
4. Subjects with a history of surgery for gastrointestinal disorders or current GI disorders that may interfere with drug absorption, or who have undergone major surgery within the 3 months prior to the screening period.