cyrilzakka/clinical-trials huggingface dataset:
Liver Transplantation for Non-Resectable Colorectal Liver Metastasis

The study aims to evaluate the efficacy of liver transplantation in the context of non-resectable colorectal liver metastasis. The primary endpoint is the overall survival in this group of patients while the secondary endpoint is the disease-free survival.

Patients included in this protocol will be evaluated either for whole or partial liver transplantation from deceased or living donors.

Type of different transplantations proposed are as follows:

1. Whole liver graft or partial liver (split) from a deceased donor
2. Partial liver graft retrieved from a deceased donor and orthotopically implanted after having performed a left hepatectomy in the recipient.
3. Partial liver graft retrieved from a deceased donor and heterotopically implanted if total hepatectomy can not be performed.
4. Partial liver graft retrieved from a living donor and orthotopically implanted after having performed total hepatectomy.
5. Partial liver graft retrieved from a living donor and orthotopically implanted after having after having performed a left hepatectomy in the recipient.
6. Partial liver graft retrieved from a living donor and heterotopically implanted if total hepatectomy can not be performed.

In cases 2-3-5-6 total hepatectomy of native liver can be secondarily performed after having achieved a proper graft hypertrophy in order to avoid a small for size syndrome


Eligibility Criteria:
Inclusion Criteria:

* Primary tumor resected according to standard oncological practice, p≤T4a, R0 resection
* Colorectal liver metastasis considered as non-resectable either up-front or after previous hepatic resections
* No local recurrence of primary colon cancer confirmed by Positron Emission Tomography, Computed Tomography and colonoscopy
* No extra-hepatic metastatic disease confirmed by Positron Emission Tomography and Computed Tomography
* Good performance status Eastern Cooperative Oncology Group 0 or 1
* Neutrophils \> 1.000
* Patients who received at least one line of chemotherapy for at least 3 months with partial response or stable disease according to modified Response Evaluation Criteria in Solid Tumours
* Carcino-Embryonic Antigen \< 80 µg/L or reduction of ≥ 50% of highest Carcino-Embryonic Antigen level observed
* Written informed consent
* No other contraindications to liver transplantation

Exclusion Criteria:

* Presence of other malignancies
* Local recurrence of primary tumor
* Extra-hepatic metastatic disease
* Patients who did not receive any neoadjuvant or adjuvant therapy
* Palliative resection of primary tumor
* Any other reason, according to the investigators, that could be a contraindication to protocol enrollment
Improved Quality of the Treatment and Increased Compliance in Asthmatics Through the Dialog Tool Soren - Between Patient and Caregiver

The purpose of the study is to assess if a dialog tool can improve compliance and asthma control in patients with asthma.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of asthma \>/= 3 months,
* Prescribed daily use of inhaled glucocorticosteroid

Exclusion Criteria:

* Asthma exacerbation within the last month
Multiple Ascending Dose of BMS-911543

The purpose of this first in human study is to determine if BMS-911543 is safe and tolerable in subjects with symptomatic intermediate-1, intermediate-2 or high risk myelofibrosis to permit clinical testing at the Maximum Tolerated Dose or at a Clinically Active Dose, and to determine if BMS-911543 will demonstrate efficacy in symptomatic myelofibrosis.


Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

* Men and Women at least 18 years old
* A diagnosis of symptomatic, primary or secondary Myelofibrosis (MF) \[World Health Organization (WHO) 2008 criteria\] with intermediate-1, intermediate-2 or high risk disease as assessed using the Dynamic International Prognostic Scoring System international prognostic scoring system
* Last therapeutic or diagnostic treatment at least 28 days prior
* Any toxicity from prior therapies must have resolved to Grade ≤1
* Adequate Liver and Kidney Function
* Serum amylase and lipase within normal institutional range
* Platelet count ≥50,000 cell mm³
* Absolute neutrophil count (ANC) ≥1,000 cells/mm3
* Hemoglobin ≥8.0 g/dL

Exclusion Criteria:

* Primary central nervous system tumors
* Subjects with currently active malignancy (other than MF) or with a prior history of malignancy with the exception of: (i) adequately treated basal cell carcinoma of the skin, (ii) curatively treated in situ carcinoma of the cervix, (iii) other malignancy that has undergone potentially curative therapy with no evidence of disease recurrence ≥3 years
* Any condition requiring chronic use of moderate/high dose steroids except inhalation or oral steroids for mild pulmonary disease
* Splenic irradiation ≤3 months prior to treatment with study drug
* Positive blood screen for hepatitis C antibody, hepatitis B surface antigen or Human Immunodeficiency Virus-1 (HIV-1), or HIV-2 antibodies
* Abnormalities in serum electrolytes
* Significant cardiovascular disease
* Current or recent gastrointestinal disease
* Previous history of pancreatitis and/or significant risk factors for pancreatitis as judged by the treating physician
* Evidence of uncontrolled active infection or active graft vs. host disease
* Inability to tolerate oral medication
To Evaluate the Pharmacokinetic Characteristics and Safety in Healthy Volunteers

The objective is to evaluate the safety and pharmacokinetic characteristics after co-administration of JW0202 and C2202 and co-administration of C2205 and JW0201 in healthy volunteers under fasting conditions

Pharmacokinetic characteristics: Describes the blood concentration statistically by pharmacokinetic blood collection time and treatment group.

Safety: All adverse events are summarized in terms of the number of subjects, expression rate, and number of expressions of adverse reactions by treatment group.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers

Exclusion Criteria:

* Subjects does not meet the Inclusion Criteria
MOWI Qualitative Assessment

This qualitative study seeks to assess whether mobile health technologies are helpful for older adults. It is the first in a series of four studies whose overarching goal is to conduct a program of pilot research aimed at developing and evaluating a technology-assisted wellness intervention for older adults with obesity who may or may not live in a rural area.

This study is designed and conducted as a series of eighteen individual semi-structured interviews and four focus group discussions. There are three participant groups: 1) older adults (age ≥ 65 years) with diagnosed obesity, 2) primary care clinicians who care for older adults, and 3) community leaders. Focus group discussions are conducted with the older adult cohort only.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥65 years;
* Body Mass Index (BMI) ≥ 30kg/m\^2;
* Waist circumference ≥88cm in females or ≥102cm in males

Exclusion Criteria:

* Severe mental or life-threatening illness
* Dementia
* Substance use
* History of bariatric surgery
* Suicidal ideation
* Unable to perform measures
* Reside in a nursing home
A Study of Istradefylline (KW-6002) for the Treatment of Parkinson's Disease in Patients Taking Levodopa

To establish the efficacy of 20 mg/day and 40 mg/day doses of istradefylline for reducing the percentage of OFF time in patients with advanced Parkinson's disease (PD) treated with levodopa.

To establish the efficacy of 20 mg/d and 40mg/d doses of istradefylline for reducing the percentage of OFF time in patients with advanced Parkinson's disease (PD) treated with levodopa. Patients who meet entry criteria will be randomized in a 1:1:1 ratio to double blind treatment with oral doses of 20 or 40mg/d istradefylline or matching placebo. Patients will be treated for 12 weeks and will have interim visits and end of treatment visit to assess the efficacy and safety of istradefylline.

Eligibility Criteria:
Inclusion Criteria:

1. UK Parkinson's Disease Society (UKPDS) brain bank criteria (Step 1 and 2) for PD.
2. PD stages 2-4 in the OFF state for Modified Hoehn and Yahr Scale.
3. On levodopa/DCI for at least one year, stable dose in past 4 weeks.
4. Currently take at least three doses of levodopa/DCI per day.
5. Predictable end of dose wearing off.
6. Able to satisfactorily complete Hauser version of a Parkinson's diary.
7. Have an average of 120 minutes of OFF time on two 24 hour diaries.
8. On a stable regimen of medications being administered within normal therapeutic limits for Parkinson's disease for at least four weeks before randomization.
9. Be at least 30 years of age.

Exclusion Criteria:

1. Neurosurgical treatment for PD.
2. History of psychosis.
3. Diagnosis of atypical Parkinsonism or secondary Parkinsonism variant.
4. Diagnosis of cancer within 5 years.
5. Diagnosis of clinically significant illness of any organ system.
6. Mini-mental status examination score of 25 or less.
7. Taking any excluded medications.
8. History of drug or alcohol abuse or dependence within the past two years.
9. History of seizures or neurological malignant syndrome.
10. Clinical depression.
11. Pregnant or lactating females.
Pneumoperitoneum and Trendelenburg Position on Fluid Responsiveness

The increased intraabdominal pressure and intrathoracic pressure due to pneumoperitoneum negatively affect the cardiovascular system, relatively dynamic parameters may vary due to intraoperative fluid therapy.

After the general anaesthesia induction and intubation, dynamic parameters such as SVV and PPV were monitored by pulse contour analysis.

Eligibility Criteria:
Inclusion Criteria:

* Age\>18 years old patients
* Will undergo elective laparoscopic gynecological surgery
* ASA I-II

Exclusion Criteria:

* Obese patients (body mass index\> 30 kg.m2)
* Patients who had arrhythmia
* Patients who had cardiac insufficiency.
Clinical Evaluation of Efficacy and Safety of a Medical Device for the Treatment of Toenail Onychomycosis

The efficacy and safety of Solver Pen (prototype number X92001704) is evaluated in this randomized, open label, controlled, investigator-blinded, comparative clinical trial in 76 patients. Subjects are treated with either the test medical device (Solver Pen) or the comparator (Loceryl, 5% amorolfine), respectively, for a period of 90 days. The primary objective of the investigation is the increase of percentage of healthy surface on the great toenail at study end versus baseline, as evaluated by a blinded investigator. Patients are followed up for a period of 90 days, with visits at D0 (baseline), D30, D60 and D90, respectively.


Eligibility Criteria:
Inclusion Criteria:

1. Patient having given her/his informed, written consent.
2. Patient cooperative and aware of the modalities of use and the necessity and duration of the controls so that perfect adhesion to the protocol can be expected.
3. Patient being psychologically able to understand information and to give their/his/her consent.
4. Age: more than 18 years.
5. Subject with superficial onychomycosis on at least one great toenail or light to moderate disto-lateral onychomycosis (without matrix involvement and involvement \<2/3 of the tablet).
6. Patient with positive KOH staining.
7. Patient having stopped any systemic antifungal treatment since at least 6 months before inclusion and/or any topical antifungal treatment since at least 3 months before inclusion.
8. Women of childbearing potential should use an accepted contraceptive regimen since at least 12 weeks before the beginning of the study, during all the study and at least 1 month after study end.

Exclusion Criteria:

1. Pregnant or nursing woman or planning a pregnancy during the investigation;
2. Patient considered by the Investigator likely to be non-compliant with the protocol.
3. Patient enrolled in another clinical trial during the test period.
4. Subject having a known allergy to one of the constituents of the tested products.
5. Patient with a condition or receiving a medication which, in the investigator's judgment, put the subject at undue risk;
6. Patient suffering from serious or progressive diseases (to investigator's discretion) such as uncontrolled diabetes, peripheral circulatory disease, HIV, psoriasis, lichen planus, immunosuppressive pathology...
7. Subject with cutaneous pathology on studied zone (other than onychomycosis like angioma, dermatitis...).
Genetic Characteristics of HER2 Positive Breast Cancer With Neoadjuvant TCHP Chemotherapy

Locally advanced breast cancer (LABC) is defined as breast cancer (BC) larger than 5 centimeters or with lymph node metastasis. Usually, LABC is treated with neoadjuvant chemotherapy (NAC) followed by curative surgery to reduce tumor size and eliminate micrometastasis. Response to NAC helps predict BC prognosis. Pathologic complete response (pCR), defined as no residual tumor cells after NAC, represents prolonged survival without BC recurrence and residual cancer burden score, based on residual tumor volume, and can more accurately predict BC outcomes. Especially, Human epidermal growth factor receptoor type 2(HER2)-positive breast cancer, having aggressive biologic characteristics, was mostly treated by NAC because of recent advance of highly effective targeted agents (pertuzumab and trastuzumab). However, still 30-40% of HER2-positive breast cancer did not response to NAC and underwent disease recurrence. Recently, genetic studies to find biomarker of BC prognosis have been widely performed. Circulating tumor DNA (ctDNA), which is circulating free DNA in the blood that originates from cancers, can be detected by recently-developed technologies. CtDNA could facilitate early disease detection, diagnosis and detection of disease recurrence. CtDNA also provides a genomic profile of BC and predicts drug response. In BC, ctDNA correlates with tumor burden and provides early detection of treatment response and tumor genetic alterations.

In this study, the investigator aimed to identify the correlations in genomic profile between tumors and ctDNA during NAC(docetaxel /carboplatin /trastuzumab and pertuzumab) in HER2 positive breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* HER2+ Breast cancer
* Stage IIA - IIIC
* Plan to receive neoadjuvant chemotherapy with docetaxel, carboplatin, herceptin, perjeta
* Sign to informed consent

Exclusion Criteria:

* Double primary cancer
Feasibility, Acceptability, and Preliminary Efficacy of a Novel Personalized Mobile Intervention for Suicide - Open Trial

The primary aim of this grant is to conduct pilot testing on a novel personalized mobile intervention for suicide - Mobile Application to Prevent Suicide (MAPS) - and to establish feasibility, acceptability, safety, and primary outcomes (i.e., suicidal ideation and behavior; re-hospitalization).


Eligibility Criteria:
Inclusion Criteria:

* Suicidal ideation and/or suicidal behavior in the past month verified by the C-SSRS
* Between the ages of 18 and 26
* English proficiency
* Comfortable with smartphone technology
* Deemed by the treatment team to be stable enough to complete study procedures

Exclusion Criteria:

* Current psychotic or manic symptoms severe enough to interfere with study procedures
MEOPA Versus Local Anesthesia for Analgesia During Chorionic Villus Sampling.

determine if efficiency of MEOPA anesthesia is at least equivalent to local anesthetics into the chorionic villus sampling in the first trimester of pregnancy

Compare anxiety discomfort and side effects

Eligibility Criteria:
Inclusion Criteria:

* pregnant
* 18 and over
* monofetal pregnancy
* chorionic villus sampling medical indication without contra indication
* informed consent signature

Exclusion Criteria:

* pregnant under 18
* multiple pregnancies
* pregnancy inferior 11 aw
* no informed consent signature
Observational Study of Botulinum Toxin Type A in Patients With Urinary Incontinence Associated With Overactive Bladder

This study will describe the prescription conditions of botulinum toxin Type A (Botox®) injection for the treatment of urinary incontinence due to neurogenic detrusor overactivity (NDO) or idiopathic overactive bladder (IOAB) as per standard of care in clinical practice in France.


Eligibility Criteria:
Inclusion Criteria:

-Patients who receive a Botox® injection for urinary incontinence.

Exclusion Criteria:

-Patients not residing in France.
Mechanisms of Mindfulness and Stress Resilience: A Mobile App Mindfulness Training Study

The purpose of this study is to test the active components of mindfulness meditation for reducing psychological stress and improving biomarkers of health. This study compares the effects of three brief trainings: (1) training in both present-moment attention and mindful acceptance, (2) training in present-focused attention, and (3) an active psychological training with no mindfulness content.

Mindfulness meditation practices are widely used among the general public, with people seeking to reduce stress, pain, inflammation, depression, and disease symptoms. Moreover, randomized controlled trials have shown mindfulness training programs to be effective in improving a broad range of psychological and physical health outcomes, particularly among populations with high stress burdens. Still, little is known about the mechanisms underlying mindfulness training that drive these effects. This study tests the active components of mindfulness that impact stress responding and health biomarkers.

The study separates attention and acceptance mindfulness instructions into three 14-day training programs delivered to a stressed adult population: (1) attention and acceptance instructions, (2) attentional monitoring instructions only, or (3) analytic thinking with no mindfulness instruction. Intervention programs are delivered on participants' own smartphones, providing a platform for maximal experimental control in testing the active ingredients of mindfulness training.

Participants are recruited from the Pittsburgh community. At a baseline laboratory session, they complete psychosocial questionnaires and tasks and provide a dried blood spot sample. On their own, they complete pre- and post-intervention Ecological Momentary Assessment measures of stress, attention, and acceptance in daily life. Between these assessments, participants have 14 days to complete their randomly assigned 14-lesson intervention program. Participants return to the lab for post-intervention assessments (questionnaires, tasks, dried blood sample), listen to a final training session from their intervention program, and complete the Trier Social Stress Test. Participants are compensated.

Eligibility Criteria:
Inclusion Criteria:

* English speaking
* Moderate- to high-stress (4-item Perceived Stress Scale score of 6 or higher)

Exclusion Criteria:

* Diagnosis of chronic mental (e.g., recurrent depression, schizophrenia, personality disorder) or physical disease (e.g., cancer, HIV, heart disease, diabetes, bleeding disorder)
* Hospitalization in past 3 months
* Medication use that interferes with HPA-axis activity (e.g., corticosteroids)
* Current oral contraceptive use
* Current antibiotic, antiviral, or antimicrobial treatment
* Travel outside the country within the past 6 months to any country on the CDC travel alert list
* Recreational drug use, excessive alcohol or tobacco use
* Significant experience with or daily practice of mindfulness meditation or related mind-body practice
Calciuric Effect and Cyclic Parenteral Nutrition in Preterm Infants

The aim of our work is to study the effect of total parenteral nutrition (TPN) cycling in preterm infants on hypercalcuria (excessive calcium excretion in urine). TPN cycling refers to administering the TPN over a portion of the day rather than the whole day. Our hypothesis is that cyclic TPN includes more hypercalcuria in preterm infants as compared to continuous TPN.

Objectives:

Measure Urinary Calcium(Ca) during the periods of continuous and cyclic TPN.

Compare the amount of Ca losses in the urine continuous vs. cyclic TPN

Randomized cross over design, in which babies will receive TPN either continuously or on a cyclic basis for 3 days. The patients will then be crossed over to receive the other way of administration over the following 3 days, thus each patient will serve as his or her own control. Continuous TPN will be administered over 24 hours for 3 days, while the cyclic TPN will be given for 18 hours then followed by a Dextrose only solution at the same concentration and rate as the TPN for 6 hours. Trophic feeds up to 20 ml/kg/day will be allowed throughout the study period at the discretion of the attending neonatologist.

Eligibility Criteria:
Inclusion Criteria:

* Preterm babies with birth weights of 1500 gm or less.
* Expected to be restricted from oral feeding or on trophic feeds
* On TPN for at least 6 days

Exclusion Criteria:

* Infants who at the time of enrollment are on any diuretics (Lasix, hydrochlorothiazide, Aldactone, etc.) or caffeine
* those who are hemodynamically unstable
* Or have renal or hepatic insufficiency
* Infants with major congenital anomalies
Community Screening Study of Diabetic Retinopathy in Tianjin in 2024

Through this study, the investigators hope to understand the prevalence and influencing factors of diabetic retinopathy in Tianjin, improve the ability of complication detection and intervention in diabetic patients in primary medical and health institutions, and build a diabetes prevention and treatment network. The investigators should adhere to the policy of prevention first, combined with prevention and control, and explore a diabetes' prevention and control model suitable for our city. Extensive publicity and education should be carried out to improve the awareness of self-management ，improve the screening rate of diabetic retinopathy, and reduce the blindness rate.

West of the city, and hebei, heping and binhai new area to carry out the work, diabetic retinopathy screening on 18000 diabetic patients in fundus examination. Tianjin medical university eye hospital, project team, formed in grassroots medical institutions are responsible for screening fundus examination in patients with diabetes, related inspection including vision, computer optometry, fundus photography and optical coherence tomography angiography (OCTA), etc. Blood samples were collected from patients in Hexi District and Heping District to detect glycosylated hemoglobin. Glycated albumin, urine ACR and CO breath test were performed in Chu Hsien-I Memorial Hospital of Tianjin Medical University. Health records were established for the screening personnel after the examination

Eligibility Criteria:
Inclusion Criteria:

- 1: Clear awareness, barrier-free communication

2: diabetes

Exclusion Criteria:

* 1: Have left the registered home address

  2: In the last 6 months, you have not lived in your place of residence

  3: Have a serious mental illness