cyrilzakka/clinical-trials huggingface dataset:
REMS Combined With TAI for Unresectable HC

The purpose of this randomized controlled study is to evaluate the efficacy and safety of the Radiation-Emitting Metallic Stents (REMS) combined with Trans-Arterial Infusion (TAI) for unresectable hilar cholangiocarcinoma.

This is a multicentric, open-labal, randomized controlled trial which aims to evaluate the efficacy and safety of Radiation-Emitting Metallic Stents (REMS) combined with Trans-Arterial Infusion (TAI) versus Uncovered Self-Expandable Metallic Stent (SEMS) Combined With Trans-Arterial Infusion (TAI) for Unresectable Hilar Cholangiocarcinoma. The primary hypotheses are that Radiation-Emitting Metallic Stents (REMS) combined with Trans-Arterial Infusion (TAI) is superior to Uncovered Self-Expandable Metallic Stent (SEMS) Combined With Trans-Arterial Infusion (TAI) with respect to Over survival(OS). The primary endpoint is overall survival. The secondary endpoints include quality of life, progression free survival, relief of jaundice, patency, and adverse events.

Eligibility Criteria:
Inclusion Criteria:

* Clinically or histopathologically diagnosis of cholangiocarcinoma
* With symptoms such as jaundice related to biliary obstruction
* Biliary obstruction of Bismuth-Correlate Classification Type III or IV
* Unresectable disease confirmed by multidisciplinary team
* Maximum diameter of lesion ≤3 cm
* Liver function of Child-Pugh A or B
* 18 years older
* With an expected survival time ≥ 3 months
* With an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
* Meet the following laboratory test parameters: hematologic function (absolute neutrophil count ≥ 1.0×10⁹/L; platelet count ≥ 50×10⁹/L; hemoglobin ≥ 90 g/L; INR \< 1.7 or prolonged prothrombin time not more than 4 seconds); liver function (ALT/AST not more than 5 times the upper limit of normal; albumin ≥ 28 g/L); renal function (serum creatinine not more than 1.5 times the upper limit of normal)

Exclusion Criteria:

* Presence of distant metastases
* With another malignancy type other than cholangiocarcinoma
* Previous history of biliary stent placement
* Moderate to severe ascites (ascites up to Child-Pugh score of 3)
* Biliary perforation
* History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 4 weeks prior to enrollment
* Unstable angina, myocardial infarction, coronary artery bypass graft, congestive heart failure, cerebrovascular accident (including transient ischemic attack, pulmonary embolism) within 3 months before enrollment
* Persistent arrhythmia (CTCAE criteria grade 2 and above), atrial fibrillation of any degree, prolonged Qtc interval (more than 450 ms in men and more than 470 ms in women)
* Refractory hypertension (blood pressure above 150/100 mmHg even after optimal drug therapy
* Concomitant receipt of other anti-tumor drugs
* Concomitant human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome
* Pregnant or lactating women
* Concomitant acute or chronic mental disorders (including mental disorders affecting subject enrollment, therapeutic intervention, and follow-up)
Standby Cannulated ECMO for High-Risk Percutaneous Coronary Intervention

The goal of this multicenter, randomized trial is to compare standby cannulated ECMO versus prophylactic ECMO in patients undergoing high-risk percutaneous coronary intervention (PCI). The main question it aims to answer is :

• If standby cannulated ECMO as compared with prophylactic ECMO will improve the outcomes in patients undergoing high-risk PCI

Although coronary artery bypass grafting is generally preferred in symptomatic patients with severe, complex multivessel, or left main disease, some patients present with clinical features that make coronary artery bypass grafting clinically unattractive. Percutaneous coronary intervention (PCI) with hemodynamic support may be feasible for these high-risk patients. Veno-arterial extracorporeal membrane oxygenation (VA-ECMO) can be used to provide hemodynamic support during high-risk PCI procedures. However, ECMO might increase the rates of severe complications, such as bleeding and limb ischemia. Additionally, some patients might not need the support of ECMO. In this context, investigators propose a standby cannulated ECMO strategy, in which femoral cannulas are inserted and connected to primed circuit, and ECMO is initiated when needed. Therefore, investigators will conduct a prospective randomized clinical trial to compare outcomes between standby cannulated ECMO versus prophylactic ECMO in patients undergoing high-risk PCI. Investigators will randomly assign 176 symptomatic patients with complex 3-vessel disease or unprotected left main coronary artery disease or severely depressed left ventricular function to standby cannulated ECMO group (n=88) or prophylactic ECMO (n=88). The primary end point was the 30-day incidence of major adverse events, including all-cause death, myocardial infraction, any repeat revascularization procedure, stroke, PCI failure, limb ischemia, bleeding, surgical revision and renal replacement therapy.

Eligibility Criteria:
Inclusion Criteria:

1. Clinicians decide to perform PCI during ECMO support.
2. Age of ≥18
3. Patient presents with a compromised ejection fraction of less than 35% or at risk of hemodynamic deterioration, or intervention on the last patent coronary conduit or an unprotected left main artery, or complex 3-vessel disease (SYNTAX score of ≥33)
4. Informed consent

Exclusion Criteria:

1. Subject in cardiogenic shock(need inotrope, pressor or mechanical support to maintain SBP \>90mmHg)
2. Presence of moderate to severe aortic insufficiency
3. Severe peripheral vascular disease
4. creatinine≥4mg/dL
5. Liver dysfunction with elevation of liver enzymes and bilirubin levels to ≥ 3x ULN
6. History of recent (within 1 month) stroke or TIA
7. Abnormal coagulation(defined as platelet count ≤50000/mm3 or Fibrinogen ≤1.50g/L)
8. Allergy or intolerance to heparin, aspirin, ADP receptor inhibitors, or documented heparin induced thrombocytopenia.
Study of Oral Debio 0123 in Combination With Carboplatin in Participants With Advanced Solid Tumors

This study has two parts: Dose Escalation and Dose Expansion. The primary objective of the study, in the Dose Escalation Part is to determine the recommended phase 2 dose (RP2D) of Debio 0123 when administered in combination with carboplatin in participants with advanced solid tumors that recurred or progressed after prior cisplatin or carboplatin containing therapy and for which no standard therapy of proven benefit is available.

The primary objective of the study, in the Dose Expansion Part is to characterize the safety and tolerability of Debio 0123 when administered in combination with carboplatin at the RP2D determined during the dose escalation part of the study and to evaluate the preliminary antitumor activity of Debio 0123 when administered in combination with carboplatin.


Eligibility Criteria:
Inclusion Criteria:

Dose Escalation:

* Histologically or cytologically confirmed locally advanced or metastatic solid and nonbleeding tumors that had recurred or progressed following standard therapy, has not responded to standard therapy or for which no standard therapy of proven benefit is available
* Able and willing to undergo tumor biopsy
* Prior platinum-based therapy (carboplatin or cisplatin).
* Life expectancy of at least 3 months
* ECOG PS 0-1

Dose Expansion:

* Histologically or cytologically confirmed, recurrent solid tumors of selected types.
* Participants must have progressed after at least 1 prior platinum-based line of therapy for advanced/metastatic disease.
* Participants must be platinum resistant (defined as progression within 6 months of completion of their most recent platinum-based chemotherapy). Prior poly (ADP-ribose) polymerase (PARP) inhibitor therapy is allowed. Platinum-based therapy does not need to be the last treatment prior to study entry.
* Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
* Documented progressive or recurrent disease according to RECIST 1.1 since the last anti-cancer therapy and prior to study entry
* Able and willing to undergo tumor biopsy
* ECOG PS 0-1
* Life expectancy of at least 3 months

Exclusion Criteria:

Dose Escalation and Dose Expansion:

* History of other malignancies requiring active treatment in the last 6 months
* Brain tumors and/or symptomatic brain metastases
* Receiving other investigating agents
* Presence of significant cardiovascular disease or other co-morbidities such as symptomatic ascites
* Prior exposure to any WEE1 inhibitor
The STEP 4Life Trial

The objective of this study is to test the feasibility of using behavioral economic interventions (gamification with social incentives) targeting daily step counts to prevent or delay the development of Alzheimer's Disease and Related Dementias (ADRD).

Increased physical activity by walking further or more vigorously may prevent or delay the development of Alzheimer's Disease and Related Dementias (ADRD) but reaching higher levels of activity and maintaining it as a long-term habit is difficult to do. This project will use concepts from behavioral science to create a game older adults can play in order to increase their levels of activity while having fun doing it. The game is played with a support partner who is a spouse, family member, or close friend who provides feedback and encouragement to help the game-player reach activity goals and maintain them as habits over time. Participants in the game will use their own smartphone and a wristwatch that tracks activity (such as a FitBit, provided by this study) to set goals, get feedback, and play the game for 12 weeks. Participants will be asked to continue wearing the wristwatch for another 6 weeks to track activity after the game is over. To determine the effectiveness of this game, investigators will randomly assign 50 people to the game and 50 people to only get the wristwatch but no game component. All participants in this study will be recruited from an online registry of adults age 55-75 who have not been diagnosed with Alzheimer's (GeneMatch) which offers genetic testing on risk for ADRD to all participants. Investigators will recruit participants who have elevated genetic risk as well as those without specific genetic risks for the study to see if either group responds differently to the game.

Eligibility Criteria:
Inclusion Criteria:

* own a smartphone
* be enrolled in GeneMatch
* know their genetic testing results (APOE4)
* able to provide informed consent

Exclusion Criteria:

* Inability to provide informed consent
* does not have daily access to a smartphone compatible with the wearable device and not willing to use a device that we can provide them
* already enrolled in another physical activity study
* unable to ambulate independently
* any other medical conditions that would prohibit participation in physical activity program
Does Tracheal Tube Size Affect Patient's Experience of Postoperative Sore Throat and Hoarseness

How tube size affect patient's experience of postoperative sore throat and hoarseness

A randomised controlled study studying how tube size affect patient's experience of postoperative sore throat and hoarseness.

The patients are randomised on the basis of gender. Men are randomized to tube size 8.0 (usual) or 7.0. Women are randomized to tube size 7.0 (usual) or 6.0.

Eligibility Criteria:
Inclusion Criteria:

* Need for intubation
* Elective surgery
* ASA Group I and II
* Understands and speaks Danish
* give one's consent

Exclusion Criteria:

* Known dementia
* SARI score \>4
* BMI \> 35
* Acute intubation
* attempt intubation \> 2
* known with previously difficult intubation
Median Effective Dose of Cisatracurium for the Prevention of Fasciculation Caused by the Injection of Succinylcholine

Succinylcholine is currently the only depolarizing neuromuscular blocker widely used in anesthesia induction and is the drug of choice for rapid sequential anesthesia induction. However, with succinylcholine, varying degrees of muscle fibrillation and muscle pain occur. Intravenous injection of succinylcholine caused by myomuscular fibrillation can cause increased intragastric pressure, intraocular pressure and intracranial pressure, increased serum potassium and postoperative myalgia, increased the incidence of adverse events such as needle prolapse, extravasation of injected drugs, and reduced perioperative comfort of patients. Pretreatment with cisatracurium provides limited prevention of muscular fibrillation due to succinylcholine, but the choice of dose often depends on user experience, and there have been no previous studies of age-related doses of cisatracurium for the prevention of muscular fibrillation caused by succinylcholine, and its half-effective amount (ED50) has not been established. In this study, patients treated with elective general anesthesia surgery were the subjects, and in the process of general anesthesia induction, cis-atracurium was pretreated to evaluate the degree of inhibition of muscular fibrillation caused by succinylcholine, and half of the effective dose of cis-atracurium inhibition of muscular fibrillation caused by succinylcholine was calculated by sequential method.


Eligibility Criteria:
Inclusion Criteria:

1. Ages ranged from 18 to 80.
2. ASA # or # level.

Exclusion Criteria:

* Allergy or contraindication to cisatracurium or succinylcholine;
* Associated with cardiovascular disease, diabetes, hyperkalemia, increased intraocular pressure, increased intracranial pressure, gastroesophageal reflux, difficult airway, malignant hyperthermia, neuromuscular disease Sick;
* Take drugs that may affect neuromuscular function before surgery
* Liver or kidney failure
* Pregnancy
Moxibustion as an Adjuvant for Benign Prostatic Hyperplasia With Lower Urinary Tract Symptoms: a Pilot Study

This study aims to explore the feasibility of moxibustion as a supplementary intervention and to assess the sample size for verifying the effectiveness and safety of integrative treatment involving moxibustion compared with conventional treatment for patients with benign prostate hyperplasia (BPH) accompanying moderate to severe lower urinary tract symptoms (LUTS).

Patients who diagnosed as BPH with moderate to severe LUTS aged 20 to 80 years old will be divided into two groups, one is moxibustion plus conventional therapy group and the other is conventional therapy group.

Patients who belong to moxibustion plus conventional therapy group will be treated moxibustion for eight times by a Korean Medicine doctor with conventional therapy by a urologist.

Patients who belong to conventional therapy group will be treated with conventional therapy only, and they can receive moxibustion therapy after the clinical trial is finished.

IPSS, post void residual volume (PVR) and peak urine flow (Qmax) will be checked to evaluate the effectiveness and safety.

Eligibility Criteria:
Inclusion Criteria:

1. Male patients aged 20-80 years diagnosed with BPH with a prostate size over 20 gm
2. greater than or equal to eight score on IPSS
3. submit written consent
4. who can understand and answer IPSS.

Exclusion Criteria:

1. prostate or bladder malignancy
2. received herbal medication for lower urinary tract symptoms within 1 week
3. history of brain disease could cause urinary difficulty
4. having problems on answering IPSS due to cognitive impairment.
5. signs of acute urinary tract infection
6. Diabetic mellitus
7. Neurogenic bladder
Exercise Intervention in Liver Transplant Patients

The purpose of this study is to learn more about the effects of exercise on functional status and outcomes on patients with end-stage liver disease on the liver transplant waiting list and who have undergone liver transplantation.

This study aims to evaluate the effects of a home-based exercise intervention on outcomes in liver transplant candidates and recipients. This home-based intervention consists of a 30-minute exercise session available on digital video disc or on the internet. This intervention was originally developed to improve functional status in community-dwelling older adults and therefore, has been designed to maximize the safety for even the most frail individuals. Subjects enrolled in this study will be randomized to one of two arms: (a) the exercise intervention arm in which the subjects will be asked perform this exercise session three to four times per week or (b) the standard-of-care arm in which the patient will be encouraged to exercise by their transplant clinician at every clinic visit. Subjects in the exercise intervention arm will undergo this intervention for 6 months. All subjects will be followed for up to two years from the time of enrollment to ascertain outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Adult (\>=18 years of age)
* Listed for liver transplantation or post-liver transplantation
* English speaking

Exclusion Criteria:

* Contraindications to weight-bearing exercise
* Non-English speaking
* Requires an assistive device for ambulation
* Active hepatic encephalopathy at the time of baseline assessment for enrollment in the study
Long-term Safety and Performance of the ARGOS-SC Suprachoroidal Pressure Sensor System in Patients With Glaucoma Underwent Non-penetrating Glaucoma Surgery

The purpose of this study is to evaluate the long-term safety and performance of the ARGOS-SC system.

This study is designed as a prospective, open-label, multicenter, single-arm clinical investigation. This study is a follow-up study to the ARGOS-SC01 study (NCT03756662). Patients who have graduated the ARGOS-SC01 study after 12 month follow-up will be asked to enroll in this study for an additional 24 month follow-up (month 12-36 post implantation). This study will be solely observational, as only patients who had implanted the device within the earlier study will be invited to join this ARGOS-SC01-FU study.

The sensor was always implanted in one eye only which will be the study eye.

Eligibility Criteria:
Inclusion Criteria:

- Subjects of the ARGOS-SC01 study with an implanted ARGOS-SC suprachoroidal pressure sensor.

Exclusion Criteria:

* N/A
Evaluation of Human Papillomavirus Vaccine Coverage in Girls and Young Women with Chronic Disease

The main objective of the study is to determine the vaccination coverage rate for human papillomavirus in adolescents aged 11 to 20 with chronic disease and treated at the Necker-Enfants Malades Hospital, compared to a population witnessed adolescent girls aged 11 to 20 years without chronic disease.

Girls and young women with chronic condition are at higher risk for infections that can be prevented by vaccination. Human papillomavirus infection is very common, one of the three most common in the general population. A vaccine exists to significantly prevent this infection and its complications.

In France, it is advisable to vaccinate girls and boys from the age of 9 years and as soon as possible in the case of acquired immunodeficiency since these patients are more likely to be suffering from cancer induced by the human papillomavirus.

In France, the overall rate of vaccination coverage for girls is 21%, which is significantly lower than in several other industrialized countries.

The vaccination coverage rate for human papillomavirus in patients with chronic diseases may be even lower.

The main objective of the study is to determine the vaccination coverage rate for human papillomavirus in adolescents aged 11 to 20 with chronic condition and treated at the Necker-Enfants Malades Hospital, compared to a population witnessed adolescent girls aged 11 to 20 years without chronic disease.

Eligibility Criteria:
Inclusion Criteria:

* Information and non-opposition of major patients and holders of parental authority of minor patients and minor patients
* Girls and young women aged 11 to 20
* To be followed at the Necker-Enfants Malades Hospital ("chronic condition" group)
* To be followed at the Specialized Medical Center for Children and Adolescents ("control" group)
* Have a chronic condition ("chronic condition" group) :

  * Diabetes type 1
  * Metabolic diseases
  * Patients followed in immuno-hematology
  * Cystic Fibrosis
  * Sickle
  * Kidney transplant
  * Heart Disease
  * Inflammatory bowel diseases
  * Rare anorectal and pelvic anomalies
* Live in France
* Comprehension of the French language (oral and written)

Exclusion Criteria:

* Have a contraindication to the HPV vaccine - Gardasil 9 (Vidal Hoptimal, 2018)
* Have a contraindication to the HPV vaccine - Gardasil (Vidal Hopitmal, 2018)
* Have a contraindication to HPV vaccine - Cervarix (Vidal Hoptimal, 2018)
Determination of the Minimum Local Analgesic Dose of Spinal Chloroprocaine in Labour

Combined spinal-epidural (CSE) analgesia has become a widely accepted approach to provide analgesia for labour pain. Despite the increasingly widespread use of this technique, an optimal intrathecal drug regimen has not been established yet.

Several investigations using local anesthetics such as Bupivacaine, Levobupivacaine and Ropivacaine in CSE during labour have been published. But despite the reintroduction of Chloroprocaine recently there haven't been any investigations about spinal chloroprocaine. Chloroprocaine is already a long-know drug with a beneficial pharmacodynamic/kinetic profile. It is known for a very quick onset of action (2 - 3 minutes), high efficacy, rapid metabolism by plasma cholinesterases and short half-life both in mother and fetus.

Because of this beneficial profile, Chloroprocaine is widely used intrathecally for surgical anesthesia. Several investigations demonstrate that for surgical anesthesia doses Chloroprocaine ranging from 30 - 60 mg are used and that they have an effective surgical duration of 40 - 90 minutes.

Despite these "standards" for surgical anesthesia, little is known about spinal Chloroprocaine dose regimens. Therefore the primary goal of this study is to determine the minimum adequate dose of Chloroprocaine that is to be given spinally to a woman in labour using a CSE procedure. We will use the up-down sequential allocation to identify the median effective dose (ED50) or concentration (EC50).

The Effective dose in 95% of the population (ED95) can be estimated also from an up-down sequential allocation and will become an important valuable approximation of the clinical dose.


Eligibility Criteria:
Inclusion criteria :

* Pregnant women in labour with a gestational period of 36 to 41 weeks
* ASA I or II
* Primi- and multiparae
* Spontaneous or induced labor

Exclusion criteria :

Pregnant women in labour who received opiates or analgetics during the 6 hour period prior to CSE