cyrilzakka/clinical-trials huggingface dataset:
Application of ICG Fluorescence Cholangiography in Laparoscopic Living Donor Left Lateral Sectionectomy

The purpose of this study was to assess the effects of indocyanine green (ICG) fluorescence cholangiography during laparoscopic left lateral sectionectomy (LLLS) on the occurrence of biliary complications in both donors and recipients in living donor liver transplantation (LDLT) and to explore the optimal dose and injection time of ICG.

This was a retrospective cohort study. The purpose of this study was to assess the effects of indocyanine green (ICG) fluorescence cholangiography during LLLS on the occurrence of biliary complications in both donors and recipients. The optimal dose and injection time of ICG were also investigated. From October 2016 to May 2022, the clinical data of 85 donors who underwent LLLS and relevant recipients in the Department of General Surgery of Huashan Hospital were retrospectively analyzed. According to whether ICG fluorescence cholangiography was used, they were divided into a non-ICG group (n=46) and an ICG group (n=39). Biliary complications were observed and the optimal dose and injection time of ICG were explored.

Eligibility Criteria:
Inclusion Criteria:

1. From October 2016 to May 2022, donors and their corresponding recipients underwent laparoscopic donor liver acquisition surgery in the general surgery department of Huashan Hospital.
2. Donor age ≥ 18 years old, regardless of gender; The receptor is the corresponding receptor of the donor, and the age and sex of the receptor are unlimited.
3. The medical history is complete, which can meet the requirements of this study.
4. Volunteer to participate in this study.

Exclusion Criteria:

1. The medical history is incomplete, which cannot meet the requirements of this study.
2. The donor or recipient expressly refused to participate in this study.
Effectiveness of 3,4-Diaminopyridine in Lambert-Eaton Myasthenic Syndrome

Hypothesis: 3,4-Diaminopyridine base (3,4-DAP) improves Lambert-Eaton Myasthenic Syndrome (LEMS)-related weakness.

The objectives of the study were to confirm the safety and to test the efficacy of 3,4-DAP in the treatment of LEMS-related weakness.

This was a phase 2 randomized double-blind placebo-controlled withdrawal study in subjects with known clinically active LEMS who had been on a chronic stable dose of compassionate distribution Jacobus 3,4-DAP provided through FDA-approved individual investigator-held INDs.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 or over
2. Ambulatory while taking 3,4-DAP, i.e. the patient was able to perform the timed up and go (TUG), either with or without an assistive device
3. Established diagnosis of LEMS, with documentation provided
4. Continuous use of Jacobus 3,4-DAP for at least 3 months
5. Minimum of 3 doses per day with no single dose less than 10 mg of 3,4-DAP
6. The patient needed to wait about 15 to 30 minutes to experience an unequivocal improvement in a LEMS-induced dysfunction after they take their first dose of 3,4-DAP in the morning \[a patient who remains in bed past this point by choice may still be eligible\]
7. Stable regimen of all LEMS-related treatments for at least 3 months
8. Stable daily regimen of other medications (prescription and over-the-counter) for a minimum of 1 month
9. Willing to chance being tapered off of 3,4-DAP
10. Fluency in English
11. If applicable, agreed to use birth control during heterosexual intercourse until at least 2 weeks after completion of study
12. A signed informed consent by the study subject

Exclusion Criteria:

1. Last monoclonal antibody treatment (e.g. rituximab) was less than 6 months ago (i.e., recent treatment is an exclusion)
2. Clinically significant or poorly controlled condition that in the opinion of the study personnel might pose an unacceptable risk to the patient if entered into the study
3. Respiratory failure requiring intubation while on 3,4-DAP with no precipitating event or medication
4. Use of any investigational drug other than 3,4-DAP within the last 30 days
5. Pregnant or lactating
6. Current use of other aminopyridines (e.g.4-AP) or guanidine
7. Did not display a sufficiently large response to 3,4-DAP during the baseline observation period in the CRU to detect a decline during withdrawal of 3,4-DAP
Open Label Extension Study of AMG 531 in Japanese Subjects With ITP

The purpose of this study is to assess the safety and efficacy of long term dosing of AMG 531 in thrombocytopenic Japanese subjects with ITP.

It is anticipated that AMG 531 will be a safe and well tolerated in long term treatment and that AMG 531 will effectively raise and maintain platelet counts to a desired therapeutic range, when individual dose adjustments based on platelet counts are permitted.

This study is available to subjects who have completed any previous AMG 531 ITP study in Japan and meet the eligibility criteria of this study.

Romiplostim was administered by subcutaneous (SC) injection once per week. If subjects entered the extension study within 12 weeks from the last investigational product administration in the previous study and had shown an increase in platelet counts ≥ 20 x 109/L from baseline at least once during the 13-week treatment period (excluding 4 weeks after receiving rescue medication), they were treated with romiplostim at the same weekly dose (last dose on study) received in the previous study. Otherwise, subjects were treated with romiplostim at a starting dose of 3 μg/kg. Dose adjustment based on platelet counts was allowed throughout the treatment period to allow subjects to maintain platelet counts in the target range of ≥ 50 to ≤ 200 x 109/L, up to a maximum permitted dose of 10 μg/kg.

Eligibility Criteria:
Inclusion Criteria

* Subjects must have previously completed an AMG 531 ITP study in Japan.
* Platelet count taken at the screening visit must be \< 50 x 109/L.
* Before any study-specific procedure, the appropriate written informed consent must be obtained.

Exclusion Criteria

* Any significant change in medical history since completion of the previous AMG 531 ITP study including bone marrow stem cell disorders or new active malignancies
* known positive result from a test for neutralizing antibodies to AMG 531 in the previous AMG 531 ITP study
* Currently receiving any treatment for ITP except oral corticosteroids, azathioprine and/or danazol administered at a constant dose and schedule from at least 4 weeks prior to the screening visit
* received intravenous immunoglobulin, anti-D immunoglobulin, or any drug administered to increase platelet counts (eg, immunosuppressants etc) within 1 week before the screening visit
* received anti-malignancy agents (eg, cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, Interferon-alfa etc) within 4 weeks before the screening visit
* received any monoclonal antibody drugs (eg, rituximab etc) within 8 weeks before the screening visit
* Less than 4 weeks since receipt of any therapeutic drug or device that is not Ministry of Health, Labor and Welfare (MHLW) approved for any indication before the screening visit (excluding AMG 531)
* Pregnant or breast feeding
* Subjects of reproductive potential who are not using adequate contraceptive precautions, in the judgment of the investigator
* known severe drug hypersensitivity
* Concerns for subject's compliance with the protocol
REDUCE LAP-HF TRIAL

The objective of this clinical study is to evaluate the safety and performance of the IASD System II in the treatment of heart failure patients with elevated left atrial pressure, who remain symptomatic despite appropriate medical management.


Eligibility Criteria:
Key Inclusion Criteria:

1. Chronic symptomatic Heart Failure (HF) documented by one or more of the following:

   1. New York Heart Association (NYHA) Class II/III/ambulatory class IV symptoms (Paroxysmal nocturnal dyspnea, Orthopnea, Dyspnea on mild or moderate exertion) at screening visit; or signs (Any rales post cough, Chest x-ray demonstrating pulmonary congestion,) within past 12 months;
   2. One hospital admission for which HF was a major component of the hospitalization within the 12 months prior to study entry (transient heart failure in the context of myocardial infarction does not qualify);
   3. On-going management with recommended heart failure medications and comorbidities for several months according to the guidelines (2012 ESC Guidelines for diagnosis and Treatment of Acute and Chronic Heart Failure).
2. Age ≥ 40 years old
3. Left ventricular ejection fraction (obtained by echocardiography) ≥ 40%
4. Elevated left ventricular filling pressures with a gradient compared to CVP documented by :

   1. PCWP or LVEDP at rest ≥ 15 mmHg, and greater than CVP, OR
   2. PCWP during supine bike exercise ≥ 25mm Hg, and CVP \< 20 mm Hg

Key Exclusion Criteria:

3. Severe heart failure defined as:

1. ACC/AHA/ESC Stage D heart failure, Non-ambulatory NYHA Class IV HF;
2. Fick Cardiac Index \< 2.0 L/min/m2
3. Requiring inotropic infusion (continuous or intermittent) within the past 6 months
4. Patient is on the cardiac transplant waiting list 4. Inability to perform 6 Minute Walk Test 5. Known significant coronary artery disease (stenosis \>70%) 6. History of stroke, transient ischemic attack (TIA), deep vein thrombosis (DVT), or pulmonary emboli within the past 6 months 7. Known severe carotid artery stenosis (\> 70%) 8. Presence of significant valve disease defined by echocardiography as: a) Mitral valve regurgitation defined as grade \>2+ MR b) Tricuspid valve regurgitation defined as grade ≥ 2+ TR; c) Aortic valve disease defined as ≥ 2+ AR or moderate AS
Study of MP0112 Intravitreal Injection in Patients With Diabetic Macular Edema

The purpose of this study is to assess the safety and tolerability of MP0112 (a novel, potentially long acting VEGF inhibitor) in patients with diabetic retinal edema.


Eligibility Criteria:
Inclusion Criteria:

* Male or female age 18 years or older
* Macular edema due to diabetic retinopathy
* Best-corrected visual acuity in the study eye of 20/40 to 20/400
* Central subfield thickness ≥ 250 microns by OCT
* Females of childbearing potential must have a negative serum pregnancy test at Screening
* Male subjects must or be: 1) surgically sterilized for at least 6 months, or 2) use an appropriate method of barrier contraception (e.g., condoms with spermicide) and advise any sexual partner of child-bearing potential that she must also use a reliable method of contraception (e.g., hormonal contraceptive, intrauterine device, diaphragm with spermicide) during the study and for 30 days from study drug administration.
* Ability to understand the nature of the study and give written informed consent
* Willing, committed, and able to return for ALL clinic visits and complete all study-related procedures

Exclusion Criteria:

* Any indication of irreversible vision loss such as significant atrophy, scarring, fibrosis, or hyperpigmentation in the fovea
* Presence of significant ocular abnormalities in the study eye that prevent retinal assessment, including media opacities, cataract, or inadequate papillary dilation
* Presence of vision loss from another ocular disease other than DME
* History of any intraocular surgery within 3 months of Baseline
* History of intraocular injection of anti-VEGF agent or steroids within 3 months of Baseline
* History of laser photocoagulation for macular edema within 4 months prior to Baseline
* Uncontrolled hypertension \> 140 systolic or \> 95 diastolic
* HbA1C ≥ 12%
* Creatinine: \> 1.5 x upper limit of normal (ULN)
* Alanine transaminase (ALT), aspartate transaminase (AST), and gamma-glutamyl transferase (GGT): \> ULN
* White blood cells (WBC), hematocrit, and platelets: \< lower limit of normal (LLN)
* Heart rate \< 60 beats per minute (bpm) or history of clinically significant bradycardia
* History of human immunodeficiency virus (HIV), chronic hepatitis B, or chronic hepatitis C infections
* Subjects with infections requiring hospitalization and/or antibiotic treatment 14 days prior to Baseline
* Subjects with any medical condition that in the judgment of the investigator could poise unacceptable risk to the subject or compromise interpretation of the data to be collected
A Pilot Randomized Controlled Trial for Hand Osteoarthritis

This is a study involving people receiving care at the Michael E. DeBakey VA Medical Center, Houston Texas. We are studying people who have hand osteoarthritis (the most common form of arthritis that involves the hand) and testing treatments for the condition with the hope that we can help to improve hand pain as well as limit the damage that occurs related to the arthritis. People who choose to participate, are randomly assigned to one of two treatments, both expected to be helpful.

The research will be conducted at the following location(s):

Baylor College of Medicine, Baylor St. Luke's Medical Center (BSLMC), and Michael E. DeBakey Veterans Affairs Medical Center.

Participants of this study are consented for the study, randomized into one of two treatment groups for hand osteoarthritis, both expected to improve hand symptoms. At the beginning of the study, many questionnaires, a physical exam, photographs of the hands, some x-rays, on a limited few people, and MRI will be obtained. Then the participants will be provided treatments for hand osteoarthritis based on the group wo which they were randomly assigned. One aspect of one of the treatments is viewed as experimental but the risks related to the treatment are considered to be low, so the risk-benefit ratio for participation in this study are good. We see patients in follow up more frequently during the first month, and then at 3 months and then 6 months of follow up. At the final visit, we will repeat the xrays and the MRIs.

Eligibility Criteria:
Inclusion Criteria:

* Enrolled to receive medical care at the Michael E. DeBakey VA Medical Center
* At least 3 joints affected by distal interphalangeal (DIP) nodal hand OA
* DIP nodal hand OA will be defined as Heberden's nodes on physical exam.
* Sufficiently severe frequent pain of at least one DIP
* Frequent pain: pain on most days of the month for at least one month in the last year.
* Minimum VAS pain severity of 40 on a 0 - 100 scale

Exclusion Criteria:

* History or current inflammatory arthritides (examples: gout, psoriatic arthritis, and rheumatoid arthritis)
* Prior surgery on the DIP joints
* Planned surgery for the DIP joints
* Pregnancy
Prevalence and Complications of Suture in the ED

included patients who had sutured wounds in the ED were asked about complications after suture .

All patients using the emergency room of EPS Fattouma Bourguiba Monastir are welcomed by a resident in the suture room. After an inclusion, patients are cared for in the outpatient circuit and the suture will be done in the dedicated box. Before discharging the patient, instructions and standardized prescriptions are given to the patient such as standard prescriptions for local wound care, removal of stitches and verification of vaccination status.

The data relevant to this study are obtained prospectively from a detailed questionnaire in the annex and a telephone call and they are completed retrospectively with the data collected in the computerized medical record.

At the healing period, between 15 days and 45 days after the suture, the investigators called the patients back in order to know the evolution of the wound, the adherence to the instructions and the prescriptions, the quality of healing and the search for complications (infection , loose stitches, hematoma, etc.)

Eligibility Criteria:
Inclusion Criteria:

* Patients with acute suturable wound

Exclusion Criteria:

Wounds requiring surgical treatment Septic wounds Chronic lesions Vascular wounds Patients who did not consent to the protocol.
Haematopoietic Stem Cell Transplantation (HSCT) in Comparison to Conventional Consolidation Therapy for Patients With Acute Myeloid Leukemia (AML) (Intermediate Risk) </= 60y. After First CR

Hematopoietic stem cell transplantation in patients with newly diagnosed AML ≤60 years of age in intermediate risk, after first complete response in comparison to standard consolidation chemotherapy


Eligibility Criteria:
Inclusion Criteria:

* AML in first remission
* cytological standard risk, i.e. karyotype not listed under exclusion criteria
* Identification of HLA-identical sibling or HLA-compatible related or unrelated donor (9/10 HLA-alleles matched, high resolution typing for HLA-A, B, Cw, DRB1 and DQB1)
* age: 18 - 60 years
* medically fit for allogeneic stem cell transplantation
* CR / CRi after induction therapy

Exclusion Criteria:

* core-binding factor leukemia (t(8;21), inv16)
* acute promyelocytic leukemia (t(15;17)
* complex aberrant karyotype
* karyotypes: -7; -5; del5q; t(3;3); t(6;11), t(6;9), 11q aberrations, trisomy 8 ± one single additional aberration
* pregnancy / nursing
* non-compliance
Nepafenac 0.1% Eye Drops, Suspension Compared to Ketorolac Trometamol 0.5% Eye Drops, Solution and Placebo

To evaluate the safety and efficacy of Nepafenac 1 mg/ml Eye Drops, Suspension, compared to Placebo and Ketorolac Trometamol 5 mg/ml Eye Drops, Solution for the prevention and treatment of ocular inflammation and ocular pain after cataract extraction with IOL implantation


Eligibility Criteria:
Inclusion Criteria:

* Patients (18 years or older) of any race and either sex, requiring cataract extraction with planned implantation of a posterior chamber intraocular lens.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Under 18.
* Other protocol-defined exclusion criteria may apply.
Pilot Study to Evaluate the Efficacy of Zidovudine in Preventing CD4+ Lymphocyte Decline in Patients With Primary HIV Infection. (One Treatment Arm Receives Placebo)

To evaluate the safety and efficacy of early treatment with zidovudine for preventing a decline in CD4+ lymphocyte counts in patients with primary HIV infection. To determine the natural history of virologic and immunologic changes in primary HIV infection.

Previous studies indicate that intervention with zidovudine during primary HIV infection could reduce the initial viral burden and subsequent decline in immune functions, and could prolong not only the time to development of AIDS but also the time to initiation of chronic antiretroviral therapy.

Previous studies indicate that intervention with zidovudine during primary HIV infection could reduce the initial viral burden and subsequent decline in immune functions, and could prolong not only the time to development of AIDS but also the time to initiation of chronic antiretroviral therapy.

Patients are randomized to receive either zidovudine or placebo daily for 24 weeks. Patients are followed until development of an AIDS-related opportunistic infection or malignancy. After week 24, patients meeting standard prescribing criteria may start FDA-approved anti-HIV therapies. After study week 48, patients may co-enroll on another clinical trial to receive experimental therapy.

Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed:

* Medications for nausea, vomiting, analgesia, or anxiety.

Patients must have:

* Asymptomatic or symptomatic primary HIV infection, plus one of the following two criteria:

  1. p24 antigenemia documented within 1 month prior to study entry and either HIV enzyme immunoassay (IA) negative or HIV IA positive with Western blot negative/indeterminate, within 1 month prior to study entry.
  2. Documented seroconversion within 1 month prior to study entry and Western blot negative/indeterminate.
* Consent of parent or guardian if less than 18 years of age.

Exclusion Criteria

Co-existing Condition:

Patients with the following condition are excluded:

* poor venous access.

Concurrent Medication:

Excluded:

* Chronic steroid use.
* Immunomodulators.
* Myelosuppressive agents.
* Other antiretroviral agents or experimental therapies (NOTE: FDA-approved therapies permitted in patients who qualify after week 24; experimental therapies permitted after study week 48).
Assessment of Functional Digestive and Genitourinary Outcomes in Patients With Rectal Cancer.

Total mesorectal excision and neoadjuvant radio-chemotherapy have revolutionized the management of rectal cancer allowing an increase in survival (between 55 and 68% at 5 years) and allowing a decrease of local recurrence (under 10%) and allowing to push the limits of sphinctyer saving procedures.

Parallel to the oncological findings, evaluating quality of life and functionnals sequelae has become a priority as highlighted by the second axis of "plan cancer 2014-2019".

The prevalence of digestive functional sequelae decrease during the first two years after surgery. However, these results are difficult to analyse due to the heterogeneity of used scores in medical litterature. The low anterior resection syndrom associate poly-exoneration, gas and / or stool incontinence, urgency and stool splitting.

The score of low anterior resection " LARS score " validated in Danemark in 2012 allow us to understand the complexity of these sequelae and to measure their impact on the quality of life of patients, that's why he is currently recommended.

In the long term, almost two out of three patients suffer from this syndrom, with half of the patients in a severe form.

However, its prevalence and severity are often underestimated by practitioners. It leads to inappropriate therapeutic measures. The aim of this study is to evaluate the impact of digestive and genito-urinary sequelae on quality of life from validated scores in patients operated curatively of rectal cancer using a population study.

This study should include 676 patients with rectal cancer treated in calvados and alive at 2 years of their proctectomy without local or general recurrence.


Eligibility Criteria:
Inclusion Criteria:

* Patients operated for a rectal adénocarcinoma with a curative aim with or without neo-adjuvating treatment in Calvados between January 1st, 2007 (date of recommendations for clinical practise) and december 31 th, 2014.
* Patients having their main address in the Calvados (at the time of diagnosis) and recorded in the register of digestive tumors of the Calvados.
* patients alive on first of january 2018 without local recurrence nor global recurrence
* patients able to understant a validated questionnaire.

Exclusion Criteria:

* Dead patients
* patients with cancer recurrence
* Patient with severe cognitive disorders (confusions) preventing the good understanding of questionnaires.
Evaluation of Food Additive Contributions to Obesity - Feasibility Study 3

The effects of food additives on body weight in humans are largely unknown. This is a feasibility study in 10 obese adults who will be followed for 5 months. Eligible participants will be non-randomly assigned to 2 groups and will be taught how to limit the exposure to the studied food additives in their diet. Primary outcomes in this study are recruitment rate, retention rate and adherence to the proposed dietary intervention.


Eligibility Criteria:
Inclusion Criteria:

* BMI \>/=30 kg/m2
* willingness and ability to follow the proposed dietary interventions
* informed consent

Exclusion Criteria:

* previous or planned bariatric surgery in the next 1 year
* current or planned participation in any structured weight-loss programs in the next 6 months
* current or recent (within the last 6 months) use of weight-loss-inducing drugs or systemic steroids
* excessive alcohol consumption
* bipolar disorder or attention deficit hyperactivity disorder
* current use of anti-depressant or anti-psychotic medications
* eating disorder or any other active disorder that may lead to significant weight changes
* pregnancy or planned pregnancy in the next 1 year
* uncontrolled diabetes mellitus or diabetes requiring treatment with \>2 oral diabetes medications or with insulin