cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Cost Analysis of Plastic Stent Compare to Metallic Stent in Hilar Cholangiocarcinoma

The purpose of this study is to compare the adequacy of unilateral endoscopic biliary drainage using metallic stent with plastic stent in unresectable, complex, hilar, cholangiocarcinoma and cost analysis.

There are two types of biliary stents: 1) the plastic stent made from polyethylene or polytetrafluoroethylene; and, 2) the metal stent braided in the form of a tubular mesh from surgical-grade stainless steel alloy and designed to expand to a maximum diameter of 10 mm. The main drawback of the plastic stent is the relatively high occlusion rate, but its advantage is the lower cost. The use of a metal stent for hilar tumor has many theoretical advantages: 1) the flexible open-mesh design should allow drainage of secondary duct branches; and, 2) its larger diameter may provide better drainage and longer patency (\~3-9 months).

Whether one type of stent is superior in terms of adequacy of drainage or cost-effectiveness remains undefined. Therefore, we would conduct this study to assess the efficacy of drainage of endoscopically-inserted, unilateral, plastic stents vs. metallic stents in unresectable, complex, hilar cholangiocarcinoma patients.

Eligibility Criteria:
Inclusion Criteria:

* Unresectable complex hilar cholangiocarcinoma which diagnosis and staging based on computed tomography(CT) or magnetic resonance cholangiopancreatography (MRCP)

Exclusion Criteria:

* Patients with ASA 4 or 5
* Patients with liver failure.
* Patients unable to comply with follow-up
Photodynamic Therapy (PDT) With Methyl Aminolevulinate (MAL) Cream in Patients With Skin Type V or IV With Acne Vulgaris

In this multicenter study, patients with dark skin and acne vulgaris will be included. The patients will receive treatment with MAL PDT and placebo PDT.

The treatment period started within 2 weeks of the study screen. Patients received two treatments (MAL PDT and vehicle PDT) to each of the treatment areas, 2 weeks apart, and were followed-up 4 weeks after last treatment. The total duration of the study was 6-8 weeks.

Methyl aminolevulinate 80 mg/g cream (MAL cream 8%)and vehicle was applied for 1.5 hours before illumination (Aktilite® CL128), total light dose 37 J/cm2

Eligibility Criteria:
Inclusion Criteria:

1. Female and male patients, age 15 to 40 years with acne vulgaris.
2. Patients with skin type V or VI (Fitzpatrick).
3. Patients with two areas of each 8x8 cm2 on the back that include at least 5 inflammatory lesions (papules, pustules, and nodules) each. The minimum distance between the two areas should be at least 4 cm.
4. Patients with no more than 2 nodular lesions in any of the two areas of each 8x8 cm2 on the back.
5. Patients who are surgically sterile, postmenopausal, abstinent, or willing to use an adequate means of contraception including birth control pills, or barrier methods and spermicide for at least 14 days prior to Day 0. Patients using birth control pills must have used the same product and dose for at least 3 months and must agree to stay with the same product and dose for an additional 3 months.
6. Patients must be willing and capable of following study instructions to the extent and degree required by the protocol.
7. Patients must sign the approved informed consent form prior to any study procedures.
8. Patients must be willing to be photographed. Patients must be willing to sign a photography consent form.

Exclusion Criteria:

1. Known allergy to MAL, to a similar PDT compound, or to excipients of the cream.
2. Participation in other clinical studies either concurrently or within the last 30 days.
3. Patients who have a condition or who are in a situation, which, in the investigator's opinion, may put the patient at risk, may confound the study results, or may interfere with the patient's participation in the study.
4. Clinically significant sensitivity to visible light, or has porphyria or porphyrin sensitivity.
5. Exposure to ultraviolet radiation (UVB phototherapy) within the last 30 days.
6. Patients with a washout period for topical treatments for their acne in the two treatment areas of less than 14 days. Any topical treatment on the face or other areas outside the two treatment areas will be allowed.
7. Patients with a washout period for oral antibiotics for treatment of their acne of less than 1 month.
8. Patients with a washout period for oral isotretinoin of less than 6 months.
Post-market Registry in Patients With Iliac Aneurysm Undergoing Endovascular Stenting With the E-liac Stent Graft System

The purpose of the study is to evaluate the clinical and technical success as well as safety and feasibility of the E-liac Stent Graft System used in endovascular treatment of uni- or bilateral aortoiliac or iliac aneurysm. Main study target is the exclusion of aneurysm with primary patency of the arteria iliaca interna and the arteria iliaca externa on iliac implantation side.


Eligibility Criteria:
Inclusion Criteria:

* Patients must comply with the indications for use
* Unilateral or bilateral common iliac aneurysm diameter equal or greater 25mm
* Unsuitable distal sealing site within the common iliac artery for traditional EVAR

Exclusion Criteria:

* Patients with a stenotic internal iliac ostium of \< 4mm in diameter
* Patients with severe internal iliac atherosclerosis
* Patients that do not have a suitable landing area in the main stem of the IIA
* Patients with pseudoaneurysms
* Patients with symptomatic and ruptured iliac aneurysms
* Patients with one of the contraindications as indicated in the instructions for use
* Patients pretreated with a bifurcated vascular graft
* Patient with thrombocytopenia
* Patient with creatinine \>2.4 mg/dl immediately before the intervention
* Patient with malignancy needing chemotherapy or radiation
* Patients who are enrolled in another clinical study
* Patients with life expectancy of less than 36 months
Mindfulness in Adolescents With Obesity

The goal of this study is to conduct a single arm open trial to examine the feasibility of a brief, adjunctive mindfulness intervention tailored to the needs of adolescents with severe obesity.

The purpose of this study is to examine whether it is feasible to integrate a brief, adjunctive mindfulness intervention with the standard medical management of obesity in adolescents with severe obesity. Mindfulness refers to the experience of paying attention to the present moment in a nonjudgmental manner. Mindfulness training enhances one's ability to cope with negative emotions and one's awareness of decision-making processes and internal experiences.

The proposed study has two specific aims: 1) to conduct a single arm open trial to examine the feasibility and acceptability of the mindfulness intervention in a sample of 15 adolescents with severe obesity; and 2) to examine the preliminary efficacy of the mindfulness intervention on BMI, emotion regulation, eating and weight-related behaviors, impulsivity, waist circumference, and blood pressure in comparison to the standard of care.

Eligibility Criteria:
Inclusion Criteria:

* between the ages of 12 - 17 years
* a current patient of our affiliated obesity clinic
* have a body mass index (BMI) between 30 and 45 kg/m2.

Exclusion Criteria:

* have a known genetic cause of obesity
* have been diagnosed with a severe intellectual or learning disability
* have been diagnosed with an autism spectrum disorder or current psychosis
* are taking a medication intended to reduce body weight
Targeting Inflammation With Losartan to Improve Response to Modulator Therapy in Cystic Fibrosis.

The goal of this clinical trial is to test use of losartan in those with cystic fibrosis (CF) on modulator therapy. The main question it aims to answer is if treatment with losartan improves response of the CF transmembrane conductance regulator (CFTR) channel to modulator therapy.

Participants will be asked take losartan or placebo for twelve weeks and will have changes in sweat chloride levels measured as a marker of CFTR function.

This is a randomized, placebo-controlled, parallel group clinical trial in those those with CF on elexacaftor/tezacaftor/ivacaftor to determine if treatment with losartan improves response to modulator therapy using sweat chloride as an marker of CFTR function.

Eligibility Criteria:
Inclusion Criteria:

* Established diagnosis of cystic fibrosis
* Age 12 years and older
* Stable use of elexacaftor/tezacaftor/ivacaftor for 90 days prior to enrollment
* Sweat chloride concentration 50 mmol/L or greater while on elexacaftor/tezacaftor/ivacaftor

Exclusion Criteria:

* Prior lung transplant
* BMI \<18
* CF pulmonary exacerbation requiring hospitalization or intravenous antibiotics in the preceding 30 days
* Systemic corticosteroid or regular non-steroidal anti-inflammatory use in the preceding 30 days
* Chronic use of angiotensin receptor blockers or angiotensin converting enzyme inhibitors
* Concomitant use of medications known to interact with losartan, including aliskiren
* Chronic renal insufficiency (creatinine clearance \<45 ml/min)
* Pregnancy or lactation
* Inability or unwillingness to comply with approved contraceptive method during the study period (females of childbearing age)
* In the opinion of the investigator any severe or acute or chronic condition or laboratory abnormality that may increase the risk associated with trial participation or make the participant inappropriate for enrollment
* Participation in another interventional trial that, in the opinion of the investigator, has the potential to affect the primary outcome
The Aging Endocrine Pancreas: Characterization of the Entero-insular Axis Physiology in the Elderly

Like most endocrine axes, the entero-insular axis is expected to go through an age-related physiological deterioration, what might contribute to special features of the elderly onset type 2 diabetes in comparison to middle-age.

Twenty four NGT volunteers will be evaluated by a meal tolerance test (MTT) for incretin hormone measurements, and by the hyperglycemic clamp followed by an arginine test for assessing the beta-cell function and the acute insulin response. Others parameters as body composition and basic biochemistry will be also evaluated at Laboratory of Investigation on Metabolism and Diabetes - LIMED / State university of Campinas, Brazil.

The characterization of the glucagon-like peptide-1 (GLP-1) production, dipeptidyl peptidase IV (DPP-IV) activity and/or endocrine pancreas incretin-response at aging, might be an interesting evidence to reinforce an incretin-based therapeutic approach for elderly onset type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Stable weight (\< 5% variation) within the last three months
* Age: 35 to 50 years old for middle-age group, and 65 to 80 years old for elderly group.
* BMI: 20 to 29.9 kg/m2
* Normal glucose tolerance (NGT) for groups Elderly and Middle-age

Exclusion Criteria:

* Use of estrogen, progestogen or systemic corticosteroids.
* Hepatic cirrhosis, renal failure or any clinical condition with impaired insulin sensitivity
* Smoking
* Obesity
* Uncontrolled systemic or debilitating diseases
A Phase I Study of Immunotherapy With GSC -Loaded Dendritic Cells in Patients With Recurrent Glioblastoma

Mono-center, un-controlled, open label, first in human, clinical trial. Approximately 20 patients (in order to achieve 12 valuable patients). The expected accrual time would range between 12 and 18 months. Follow-up, including clinical, immune and radiological monitoring will end two years after the initial surgery of the last patient enrolled. The primary objective will be to assess the activity of immunotherapy in terms of its effect on immune response. In particular we will investigate the effect of treatment on effector cells including CD8 T cells, NK cells and Natural Killer T (NKT) cells. The sample size of 12 eligible patients was identified on ethical and practical considerations, rather than by a formal sample size calculation.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 and ≤70 years;
* Histological diagnosis of de novo GBM (i.e. not secondary GBM);
* Gross total resection as evaluated by MRI performed within 72 hours from surgery;
* Karnofsky Performance Status (KPS) ≥60 at the time of first progression;
* Written informed consent.

Exclusion Criteria:

* Pregnancy or breast feeding;
* Participation in other clinical trials with experimental drugs simultaneously;
* Mandatory treatment with corticosteroids or salicylates in anti-inflammatory dose;
* Presence of sub-ependymal diffusion of the tumor;
* Presence of multi-focal GBM lesion;
* Haematology: leukocytes (WBC) \< 3x103/μl, absolute lymphocyte count\< 0.5x103/μl, Absolute neutrophil count (ANC) \< 1x103/μl, hemoglobin\< 9 g/dL, platelets\< 50x103/μl within two days prior to leukapheresis;
* AST (SGOT)/ALT (SGPT) ≥3 X institutional Upper Limit Normal (ULN) at the time of leukapheresis;
* Serum creatinine\>1.5 ULN or calculated creatinine clearance \< 60 ml/min at time of surgery;
* Documented immune deficiency;
* Documented systemic autoimmune disease;
* Positivity for HBV, HIV, HCV, Treponema Pallidum;
* Allergies to any component of the DC vaccine;
* Other active malignancy.
Comparison of Creatinine Clearance Calculation for Estimation of GFR in Patients Receiving HD Methotrexate

The purpose of this study is to compare different estimates of calculating creatinine clearance by mathematical formula and compare them to creatinine clearance based on a timed urine collection in patients who received high-dose methotrexate for the treatment of primary CNS lymphoma or CNS involvement of systemic lymphoma.

We intend to perform a retrospective chart review to identify a serum creatinine-based equation that gives the best estimate of CrCl as compared with an equation derived from a 24-hour urine collection.

Study subjects will be identified using the Brigham and Women's Hospital and Dana-Farber Cancer Institute's Adult Pharmacy systems to identify patients who received high-dose methotrexate. Data will be collected starting with December 31, 2010 and proceeding chronologically backwards until the target enrollment of 40 patients is reached.

Eligibility Criteria:
Inclusion Criteria:

* Age \>/= 18 years
* Received high-dose methotrexate therapy at Dana-Farber Cancer Institute/Brigham and Women's Hospital for the treatment of primary CNS lymphoma or CNS involvement of systemic lymphoma
* Available timed urine collection within 1 week of HDMTX

Exclusion Criteria:

* Receiving high-dose methotrexate for indications other than primary CNS lymphoma or CNS involvement of systemic lymphoma
* Documented viral hepatitis
Effectiveness and Costs of Internet-based Treatment for Harmful Alcohol Use and Face-to-face Treatment in Addiction Care

The purpose of this trial is to compare the effectiveness and costs of a five-module Internet-based treatment program (including therapist support) for harmful alcohol use with the effectiveness and cost of the same treatment content delivered face-to-face in specialized addiction treatment. The hypotheses to be tested through this trial are that:

1. The Internet-based treatment program (including therapist support) is as effective (reducing alcohol consumption) as the same treatment content delivered face-to-face in specialized addiction treatment.
2. The Internet-based treatment program (including therapist support) is associated with lower cost per treated individual in relation to the achieved effects (in terms of reduced alcohol consumption) compared with the same treatment content delivered face-to-face in specialized addiction treatment.

The design is a two-armed randomized controlled trial, and outcomes are measured in terms of changes in alcohol consumption, problematic alcohol use as well as alcohol dependence, depression, anxiety, quality of life and costs for the treatments. A minimum of 350 participants will be recruited and randomized into two groups:

Intervention group 1: All participants in this group will have access to the five-module Internet-based treatment program for harmful alcohol use and have access to a therapist with training in psychotherapy (CBT) who assists and counsels the participant throughout the program.

Intervention group 2: All participants in this group will attend five face-to-face treatment sessions in specialized addiction treatment.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* 16 points on Alcohol Use Disorders Identification Test or at least 3 criteria on the International Classification of Diseases (ICD-10) for Alcohol Dependence
* Resident in Stockholm County

Exclusion Criteria:

* Lack of understanding of the Swedish language.
* Doctor's assessment that there is a risk for severe withdrawal symptoms, risk for suicide or mental illness requiring separate care.
* Doctor's assessment that there is a need for medication for alcohol dependence.
Effects of Probiotics and Electrophysiologic Therapy on Endometrium Repair

This study aimed to investigate the effects of probiotics in combination with pelvic floor muscle electrophysiologic therapy on the uterine endometrial repair and reproductive prognosis in patients after surgery for intrauterine adhesion

Post-traumatic repair disorder of endometrium can cause intrauterine adhesions, amenorrhea and infertility, which seriously endanger women's reproductive health. In our previous study, high throughput sequencing of intrauterine microorganisms showed that the content of lactic acid bacteria in the uterine cavity of patients with intrauterine adhesions was significantly lower than that of normal people. Concurrently, our previous studies found that chronic endometritis can aggravate endometrial fibrosis, then affect the repair of endometrial trauma, and increase the recurrence of intrauterine adhesion. Our previous study also suggest that stem cells are beneficial to the repair of endometrium. Studies have shown that lactic acid can inhibit inflammatory response and regulate the proliferation of intestinal stem cells. So can lactic acid also change the microbial environment in uterine cavity to inhibit endometrial inflammation and regulate the proliferation of endometrial stem cells to help repair endometrial wounds? In addition, electrical stimulation can relieve depression and anxiety and play a sedative effect. In recent years, some studies have shown that pelvic floor electrophysiological therapy can improve the intimal blood flow resistance index of thin endometrium. Therefore, whether or not the pelvic floor electrophysiological therapy can repair the endometrium after the intrauterine adhesion. We expect probiotics and electrophysiologic therapy can promote endometrial repair after electrosurgical resection of intrauterine adhesions.

Eligibility Criteria:
Inclusion Criteria:

(1) Preoper- ative AFS score was ≥9; (2) the prior menstrual cycle was regular, and the sex hormone was normal; (3) patients had fertility requirement; (4) male semen examination appeared normal; (5) there were no severe systemic diseases and no contradictions to aspirin, estrogen, and surgery

Exclusion Criteria:

(1) Preoperative AFS score was \<9; (2) prior menstrual cycle was irregular and sex hormone was abnormal, or patients had endocrine factors that caused amenorrhea, menstrual reduction, and infertility; (3) patients had no fertility requirement; (4) patients had male factor infertility; (5) patients had contradictions to estrogen and aspirin such as cancers (breast cancer and endometrial cancer), thrombotic diseases, allergy to antipyretic anal- gesics, severe liver injury, hypoprothrombinemia, vitamin K deficiency, hemophilia, thrombocytopenia, and gastric or duodenal ulcer and asthma
Multicenter Orthopaedics Outcomes Network for ACL Reconstructions

The purpose of this study is to determine the effect of modifiable risk factors on knee function, osteoarthritis, and re-rupture of the anterior cruciate ligament (ACL) following ACL reconstruction.

Disruption of the anterior cruciate ligament (ACL) is among the most frequent musculoskeletal injuries affecting physically active men and women. An estimated 200,000 ACL reconstructions (ACLR) are performed annually, and the incidence of this injury is roughly 1 in 3000 per year. ACL injury has both immediate and long-term implications for an injured person's quality of life, their risk for osteoarthritis (OA), and long-term disability. Currently, ACLR is recommended as the standard of care following an ACL tear based on evidence for improved instrumented laxity, the desire to return to sports play, and evidence for a reduction in future knee injuries.

In this research we propose to identify risk factors measurable at the time of injury/surgery in order to estimate the magnitude of the effect of these factors on important quality of life and clinical outcomes (e.g.,OA and incidence of additional surgery) 2 to 10 years after a patient's ACL reconstruction.

AIM 1. To identify risk factors for reduced quality of life 2-20 yrs post-ACLR, from information available at the time of surgery; including the characteristics of the patients (age, gender, body mass index, activity level, clinical knee alignment) and their injuries (concurrent meniscus, articular cartilage, and collateral ligament injuries), and treatment decisions made during the initial surgery (e.g., graft choice, meniscus and articular cartilage treatments).

AIM 2. To identify risk factors for symptoms and signs of osteoarthritis 2-20 years post-ACLR, from information available at the time of surgery; including the characteristics of the patients (as above) and their injuries (as above), and treatment decisions made during ACLR (as above).

AIM 3. To identify risk factors for recurrent ligament disruption and additional arthroscopic knee surgeries of the ACLR knee, from among the characteristics of the patients (as above), their initial injuries (as above), and treatment decisions made during ACLR (as above).

The overarching goal of this study is to establish evidence-based medicine practices of counseling patients on prognosis, guiding surgeons on treatment of meniscus and articular cartilage injuries, and post-surgical care, as well as the appropriate evidence for future interventional trials in the targeted subset of ACLRs with poorer outcomes.

Eligibility Criteria:
Inclusion Criteria:

- All ACL-deficient candidates scheduled for a unilateral ACL reconstruction at one of the participating MOON sites.

Exclusion Criteria:

* Persons undergoing a simultaneous bilateral ACL reconstruction
* Patients less than 10 years old and older than 80 years old
* Patients unwilling or unable to complete their follow-up questionnaire