cyrilzakka/clinical-trials huggingface dataset:
Unilateral Stenting Versus Bilateral Stenting for Malignant Hilar Biliary Obstruction

The purpose of this study is to compare the clinical effectiveness and long-term outcomes between patients with malignant hilar biliary obstruction who are treated by unilateral or bilateral stenting.

Malignant hilar biliary obstruction is a common clinical manifestation and it can be caused by cholangiocarcinoma, gallbladder carcinoma, liver cancer, or other metastatic carcinoma. Most patients with malignant hilar biliary obstruction are unresectable at diagnosis. Biliary stenting has been widely used in palliative treatment of malignant hilar biliary obstruction.

Hilar biliary obstruction usually involves the bifurcation of the biliary tract. Some researchers recommended unilateral stenting for malignant hilar biliary obstruction because drainage of 25% of entire liver can achieve the clinical success of biliary drainage. However, some researchers recommended bilateral stenting for malignant hilar biliary obstruction because some researches demonstrated that bilateral stenting can achieve a longer stent patency.In addition, there was no significant difference in post stenting survival between patients who were treated by unilateral or bilateral stenting. Therefore, it remains under debate whether unilateral or bilateral stenting is better in the treatment of malignant hilar biliary obstruction.

The purpose of this study is to compare the clinical effectiveness and long-term outcomes between patients with malignant hilar biliary obstruction who are treated by unilateral or bilateral stenting.

Eligibility Criteria:
Inclusion Criteria:

1. Malignant hilar biliary obstruction;
2. Unresectable cases

Exclusion Criteria:

1. Bismuth I patients;
2. inability to obtain informed consent;
3. Eastern Cooperative Oncology Group performance status of 4;
4. severe dysfunction in other organs.
Early Outcomes of Arthroscopic Versus Open Reduction for Developmental Dysplasia of the Hip in Children

This study was designed to determine whether arthroscopic-assisted reduction offers better early surgical outcomes than open reduction for treating developmental dysplasia of the hip in children. By comparing these two approaches, the researchers sought to find out if using an arthroscopic-assisted method could lower redislocation rates, shorten operative time, reduce blood loss, maintain acceptable acetabular alignment, and potentially decrease the risk of complications such as avascular necrosis, thereby improving the quality of care and long-term hip function for affected children.

This investigation evaluates two distinct surgical strategies for managing developmental dysplasia of the hip (DDH) in young children using a comparative, parallel-group design. The technical approach under consideration involves an arthroscopic-assisted procedure, which provides direct visualization of the hip joint structures through minimally invasive portals. By employing specialized instruments and an arthroscopic camera system, surgeons can assess ligamentous and capsular integrity, identify obstacles to proper femoral head positioning, and address intra-articular pathologies with potentially less disruption to the vascular supply and surrounding soft tissues than is typical in conventional open surgery. The surgical team implemented stringent measures to maintain uniformity in anesthesia protocols, operative setup, and postoperative immobilization strategies, ensuring that any observed differences would more likely be attributable to the surgical technique rather than confounding variables. Additionally, advanced imaging modalities, including fluoroscopic guidance where appropriate, were used intraoperatively to confirm adequate reduction and optimize acetabular coverage. The study's procedural protocols were developed in consultation with senior pediatric orthopedic surgeons experienced in both techniques and piloted to establish feasibility before patient enrollment commenced. In this manner, the investigation aims to refine the understanding of arthroscopic-assisted hip reconstruction in the pediatric population, providing insights that may influence future surgical guidelines, training curricula, and patient care pathways.

Eligibility Criteria:
Inclusion Criteria:

* Children diagnosed with DDH (Tönnis grade II-IV)
* Age range: 12 to 24 months at the time of the first surgical reduction
* A documented failed attempt at conservative reduction (e.g., closed reduction) prior to enrollment

Exclusion Criteria:

* Presence of neuromuscular disorders
* Teratologic hip dislocation
* Prior surgical intervention on the affected hip
* Incomplete radiographic documentation (missing radiographs at any of the required assessment intervals)
A Phase II Study of Subcutaneously Injected PD-L1 Antibody ASC22 in Chronic Hepatitis B Patients

The objective of this study is to evaluate the safety and efficacy of ASC22 in the treatment of chronic hepatitis B after single and multiple drug administration.

The study consists of two parts: the ASC22 single-dose IIa study and the ASC22 multi-dose IIb study. The IIa study consists of 3 cohorts of 0.3mg/kg, 1.0mg/kg and 2.5mg/kg, and the IIb study consists of 2 cohorts of 1.0mg/kg and 2.5mg/kg. The objective is to evaluate the safety, tolerance and efficacy of ASC22 in patients with chronic hepatitis B (CHB), and to provide a guidance for the determination of dosage regimen.

Eligibility Criteria:
Inclusion Criteria:

1. 18-65 years old (including boundary value), gender unlimited；
2. Chronic hepatitis B patients with clear diagnosis of Hematology, etiology and clinical (for example: HBsAg positive for more than 6 months);
3. HBV-DNA turns negative after treatment with nucleoside (acid) drugs;
4. cohort1-5:HBsAg≤ 10000 IU/mL; cohort6: HBsAg≤ 100 IU/mL;
5. HBeAg negative;
6. The fertile female subjects or the fertile male subjects agreed to take contraceptive measures from 7 days before the first administration until 24 weeks after the end of the administration cycle of ASC22. The serum pregnancy test of fertile female subjects must be negative within 7 days before the first administration.

Exclusion Criteria:

1. Patients with hepatitis a, hepatitis c (HCV RNA\>15IU/L), hepatitis d or HIV infection; Patients with other active infections (e.g., respiratory tract infection, urinary tract infection and herpes simplex, cytomegalovirus, epstein-barr virus);
2. Fibrosis stage: Cirrhosis, portal hypertension, or advanced fibrosis (defined as Fibroscan≥9.5kPa or ARFI≥1.81m/sec or Fibrosis-4 (FIB-4)≥3.25 or METAVIR F≥3);
3. Liver cancer patients or blood AFP\>1×ULN;
4. cohort1-5：Patients who received interferon therapy within 6 months before the first administration; cohort6: Patients who received interferon therapy before the first administration;
5. Patients receiving immunosuppressive therapy within 3 months before the first administration (except interferon);
6. The investigator judges that the participants are not suitable for this study.
DAHANCA 25A: Resistance Training and Dietary Supplements as Intervention for Regaining Muscle Mass Following Radiotherapy in Head and Neck Cancer Patients

The purpose of this study is to investigate whether resistance training in combination with dietary supplementation is tolerable among head and neck cancer patients and to evaluate the possible effect on muscle mass, strength and functional capacity.

Head and neck cancer patients experience a significant loss of muscle mass following radiotherapy treatment due to cachexia and dysphagia. This negatively affects muscle strength and functional capacity.

Studies on healthy individuals and various groups of patients show that resistance training in combination with protein and creatine ingestion is an effective means of increasing muscle mass, strength and functional capacity.

Thus the aim is to investigate the following:

* is resistance training and dietary supplements tolerable among head and neck cancer patients
* the effect of the intervention on muscle mass, strength and functional capacity

Eligibility Criteria:
Inclusion Criteria:

* head and neck cancer patients (localized to the larynx, pharynx and oral cavity) treated with curative radiotherapy
* complete loss of tumor
* WHO performance status between 0-1 and expected ability to complete the training protocol
* No parenteral feeding
* above the age of 18
* written concent

Exclusion Criteria:

* other malignant diseases
* pregnancy
* undergoing systematic resistance training or creatin ingestion
* Alcohol abuse
Clinical Trial to Evaluate the Immunogenicity and Safety of an Adjuvanted A(H1N1)v Influenza Vaccine and a Non-adjuvanted A(H1N1)v Influenza Vaccine in HIV-infected Patients (ANRS 151 Hifluvac)

A 1-year multicenter, randomized, single-blinded, phase II trial, stratified on HAART. The purpose of this trial is to evaluate the immunogenicity and safety of a A(H1N1)French National Agency for Research on AIDS and Viral Hepatitis influenza vaccine, administered with or without adjuvant, in HIV-infected patients after one or two injections.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Able to give written consent
* Covered by French Social Security
* HIV-infected (infection attested by the patient's chart)
* Patients treated by HAART for at least 6 months, with a viral load inferior to 50 copies/mL on at least 2 last visits
* Patients without any treatment for HIV for at least 6 months and without any indication to start a treatment in the following 3 months
* Patients followed for their HIV-infection in an ANRS center and whose home is close to the center in case of influenza-like illness, consultation and hospitalization in the center where he is followed if necessary
* For women with childbearing potential, using an effective method of contraception, and willing to undergo urine pregnancy tests prior to each vaccination.

Exclusion Criteria:

* Pregnancy
* Receipt of chemotherapy, immunotherapy (IL2, IL7, IV Ig), or corticosteroids within 3 months prior to enrolment
* Thrombopenia inferior to 20 000/mm3
* Febrile episode (at least 38°C rectal or if at least 37,5°C measured orally) within one week prior to vaccination
* Opportunistic infection (treated for less than 1 month)
* Co-infection with HCV and treated with IFNa
* Influenza (clinically or virologically documented) in the last 6 months
* History of documented auto-immune disease (lupus, systemic inflammatory disease, ...)
* Child C cirrhosis
* Solid organ transplant recipient
* Intolerance to 1 component of the vaccine
* Other immunization received within 3 weeks prior to inclusion or planned until after the last vaccine injection.
Risk Factors for Morbidity After Incisional Hernia Repairs

The Danish Ventral Hernia Database (DVHD) registers 37 different perioperative parameters. The aim of present study is to use large-scale data from DVHD to uncover risk factors for readmission, reoperation (any indication), death and reoperation for recurrence after incisional hernia repair.

All principal incisional hernias registered in the Danish Ventral Hernia Database are included in the study. The included patients will be followed in up to 4 years in order to identify correlation between technical aspects of the hernia repair and postoperative morbidity.

Eligibility Criteria:
Inclusion Criteria:

* Incisional hernia repair
A Prospective, Single-center, Randomized, Controlled, Open-label, Pilot Study to Compare the Effectiveness and Safety of DIuretics Add-On Strategy in Acute Decompensated Heart Failure Patients (DIOS II)

To compare the effectiveness and safety of diuretics add-on strategy in chronic heart failure patients


Eligibility Criteria:
Inclusion Criteria:

1. dyspnea at rest or minimal activity
2. tachypnea (respiratory rate \> 20/min) or rales or pulmonary edema on chest X-ray

Exclusion Criteria:

1. hospitalization for acute heart failure decompensation
2. cardiogenic shock (Systolic Blood Pressure \< 80mmHg)
3. Need or plan for renal replacement therapy (dialysis, kidney transplant)
4. serum creatine level \> 2.5mg/dl
5. serum potassium (K+) \> 5.5mg/dl
6. Age \> 80 years old or poor compliance patients
7. allergy, adverse drug reaction, hypersensitivity to any kinds of diuretics
8. life expectancy \< 6 months (e.g. metastatic malignancy, liver cirrhosis)
9. pregnancy or women at age of childbearing potential
Premature Rupture of Mambrane and Unfavourable Cervix

The paucity of published data concerning the issue of mechanical labor induction in the setting of Term PROM has led us to undertake the present clinical trial. This study is designed to compare the efficacy and safety of the standard Oxytocin induction protocol with the double-balloon catheter device with concurrent oxytocin administration in patients with Term PROM and unfavorable cervical conditions.

This will be a prospective randomised trial. Two hundred pregnant women with term PROM and an unfavourable cervix (Bishop Score ≤ 4) are expected to be entered into the study (see statistical analysis below).

All eligible women will be presented with the study protocol by a study coordinator. Women interested in participating will read and sign the informed consent. Subsequently, the following screening medical procedures will be completed: medical and gynecological history, physical and vaginal examination, ultrasonography to: (i) Confirm fetal vertex presentation, (ii) Exclude placenta previa and (iii) Assess cervical length and posterior cervical angle. (iv) Asses bio-physical profile score

A non-stress test will be performed in order to monitor:

1. The fetal heart pattern for the presence or absence of decelerations and
2. The presence of uterine contractions. All women will undergo a pelvic examination by a staff member to obtain an initial Bishop score.

If the patient will be determined eligible for study entry, and following the informed consent, randomisation into the following groups will take place:

GROUP 1: Oxytocin infusion alone (Standard Protocol). GROUP 2: insertion of the double balloon device and concurrent oxytocin administration.

GROUP 3: Expectant management

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed to be pregnant with PROM at \> 34 week
2. Found to have a Bishop score of 4 points or less.
3. Diagnosed as having a singleto
4. Willingness to comply with the protocol for the duration of the study.
5. Have signed an informed consent.

Exclusion Criteria:

1. Any contraindication for a vaginal deliver
2. Regular uterine contractn
3. Evidence of chorio-amonitis
4. Previous cesarean section or presence of any uterine scar.
5. Suspected placental abruption or presence of a significant hemorrhage.
6. Non-reassuring fetal statu
A Study of Adolescents Undergoing a Mindfulness Training During COVID-19

The COVID-19 pandemic has been significantly affecting people's lives around the globe. Social distancing, self-quarantine, shelter-in-place measures, economic challenges, and COVID-19-cased illness and deaths have the potential to significantly impact mental health and cause stress, anxiety, and depression. Adolescents may be especially vulnerable to this situation, due to their increased vulnerability to the onset of depression and anxiety in general.

One promising approach to reduce anxiety and depression in youth is a neuroscience-based mindfulness intervention Training for Awareness Resilience and Action (TARA). TARA is usually delivered over 12 weeks by two facilitators in groups of 10-15 adolescents in-person, and it has been shown to reduce symptoms of depression and anxiety in depressed adolescents and modify brain properties. The TARA intervention can also be delivered remotely. Other types of therapy delivered remotely, such as internet-based cognitive behavioral therapy, have shown comparable efficiency to face-to-face delivery.

The objective of this study is to utilize an individually randomized group treatment, open-label, waitlist-controlled clinical trial to test the feasibility of TARA (delivered partially over Zoom) in improving the self-reported emotional well-being primary outcome (emotional problems measured with the Strengths and Difficulties Questionnaire \[SDQ\]) in healthy adolescents between the ages of 14 to 18 years old during the COVID-19 pandemic.

Our central hypothesis is that emotional well-being of adolescents in the intervention group will improve stronger (or deteriorate less) than in the control group. We will test this hypothesis in 21 adolescents randomized to the TARA intervention (partially delivered over Zoom) (12 adolescents) or to the waitlist control group (9 adolescents).


Eligibility Criteria:
Inclusion Criteria:

* Healthy female and male adolescents, 14-18 years old
* Fluency in English

Exclusion Criteria:

* Subjects younger or older than 14-18 years old.
* Subjects who are not healthy. Subjects who are taking any psychotropic medication.
* MRI contraindications (ferromagnetic objects on or inside the body, e.g., braces) and pregnancy.
* Not allowable: Current mindfulness training (e.g. MBSR, MBCT, DBT) and/or practice with a typically sitting meditation or yoga of 20 or more minutes two or more times per week within 60 days prior to study entry.
* Potential adolescent subjects with current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to the study requirements will be excluded and not allowed to enter the study.
* Potential subjects with an inability or unwillingness to give written informed assent or whose legal guardian/representative are unable or unwilling to give written informed consent will be excluded and not allowed to enter the study.
Efficacy and Safety of Shinbaro Capsule

The purpose of this study is to evaluate the efficacy and safety of 'Shinbaro Capsule', a new herbal anti-arthritic agent, in patients with osteoarthritis of the knee.


Eligibility Criteria:
Inclusion Criteria:

* age between 35 and 80
* diagnosed with Knee OA based on criteria of ACR and showed ont through I \~ III of Kellgren Stage on radiography
* wuffered constantly with Knee OA for more than 6 months prior to begining the study
* scored more than 30 on total WOMAC scale

Exclusion Criteria:

* had other comorbid orthopedic disease
* had OA of index knee from significant trauma or surgery
Percent Weight Change in the Medical Supplement Group of Early Breast Cancer

The goal of this RCT is to compare percent weight change in early breast cancer who takes medical supplement or not, during treatment with chemotherapy (standard AC regimen).

The main question is

• the change of weight (%) before and after complete treatment of breast cancer therapy.

Participants will be randomized into 2 group

* intervention group - receive medical supplement daily during chemotherapy treatment.
* control group - Nutritional advise during chemotherapy treatment.

1. The rational is to prove the hypothesis is that, the effect of medical supplement with nutritional advise can prevent the reduction of body weight, malnutrition and treatment complication, which eventually to improve of the quality of life.
2. Primary endpoint of the study is to compare the effect of medical supplement on percent weight change in early breast cancer who received chemotherapy in Rajavithi hospital. Secondary endpoints are nutritional status (PG-SGA), quality of life.
3. Sample size formula based on Bernard R. Fundamentals of biostatistics. 5th ed. Duxbery: Thomson learning; 2000. Enrollment of 40 patients.
4. Randomization into 2 groups. Intervention arm : receive medical supplement daily (1 drink = 6 scoops in 250 ml water, 2 drinks/day) with nutritional advise. Control arm : nutritional advise only. Duration of treatment is 12 weeks
5. Enrollment and data monitoring is assessed by the staffs of oncology department in Rajavithi hospital and the data will be recorded in computer based information system.
6. Data assessment on week 0,6,12 during chemotherapy treatment.
7. Data analyzed by descriptive statistics to characterize patients at entry. We did the efficacy analyses with intention to treat population
8. We did analyses with R version 3.3.0.

Eligibility Criteria:
Inclusion Criteria:

* Histopathological confirmed diagnosis of breast cancer
* Breast cancer stage I-III
* Recieve adjuvant or neoadjuvant doxorubicin and cyclophosphamide at Rajavithi hospital
* LVEF \>= 60% - ECOG score 0-1

Exclusion Criteria:

* No indication for chemotherapy
* Contraindication for chemotherapy
* Breast cancer stage IV
* Diabetic mellitus who requires insulin injection
* BMI \>= 30 kg/m2 or \<= 16 kg/m2
* Previously known other malignancies
* Second primary cancer
* Previously received chemotherapy or radiotherapy
* Severe malnutrition with administration of TPN is indicated
* Pregnancy or lactation
* CKD stage 4-5
Safety Extension Study to Evaluate the Biodegradation of the Brimonidine Tartrate Posterior Segment Drug Delivery System

This study will evaluate the biodegradation of the brimonidine tartrate posterior segment drug delivery system.


Eligibility Criteria:
Inclusion Criteria:

* Received the most recent sham or active study treatment of intravitreal Brimo PS DDS® no later than 36 months prior to entry into this study and have either completed their previous study, or have exited early from their previous study for any reason
* Applicable studies: Previous Allergan intravitreal Brimo PS DDS® treatment studies

Exclusion Criteria:

- None
Clinical Performance of Nano Plus Sirolimus-Eluting Stents in Patients With Coronary Artery Disease

The study aims to evaluate the safety and efficacy of polymer-free sirolimus-eluting coronary stent system (NANO plus) in patients with coronary artery disease . The primary endpoint is target lesion failure, a composite endpoint of cardiac death, target vessel related myocardial infarction and clinically-driven target lesion revascularization at 1 year follow-up.

This is a prospective, multicenter, single arm clinical registry investigating the safety and efficacy of polymer-free sirolimus-eluting coronary stent system (NANO plus) in patients with coronary artery disease . In total, we plan to recruit 2500 patients in real world setting. The patients will be followed clinically at 1-, 6- month and 1-, 2-, 3-, 4-, 5-year. All clinical data will be collected and managed by statistical center, clinical endpoint adjudication committee.

Eligibility Criteria:
Inclusion Criteria:

* 18-85 years old, male or non-pregnancy female;
* Patients with coronary artery disease who match the indication of stent implantation;
* Patients who can understand the nature of the study, agree to participate and accept clinical follow-up;

Exclusion Criteria:

* Patients who can not tolerate the material or medication in this study;
* Pregnancy or lactation women
* Patients who had participated in another investigational drug or device trial that has not completed the primary endpoint;
* Patients are, in the opinion of the investigator, unable to comply with the requirements of the study protocol
Non-invasive Haemodynamic Monitoring in Pregnancy

This prospective and observational trial over 55 pregnant women (third trimester) compares non invasive haemodynamic monitoring using Nexfin technology and ultrasonography technic


Eligibility Criteria:
Inclusion Criteria:

* third trimester of pregnancy
* Non-labouring pregnant women
* accepting study

Exclusion Criteria:

* refusal of study
* first or second trimester of pregnancy