cyrilzakka/clinical-trials huggingface dataset:
Hemodynamic Measurements During Liver Transplantation

The purpose of the study is to determine if the less invasive monitors are as reliable for measuring heart function in patients undergoing liver transplantation as the more invasive pulmonary artery.

Pulmonary artery catheter (PAC)is considered the gold standard in monitoring of heart function during orthotopic liver transplantation (OLT). Placement of PAC is very invasive (it passes thorough the heart chambers and into the pulmonary artery) and its benefits on the outcomes have not been proven. This study compares two newer FDA approved much less invasive devices to the PAC. The two new devices assess the heart function based either on the peripheral arterial waveform alone (Vigileo, Edwards Lifesciences)or the combination of peripheral arterial waveform and chemical indicator dilution (LiDCO, Cambridge, UK).

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years of age
* Scheduled for liver transplantation
* Patient undergoing vascular surgery where invasive arterial pressure is indicated (control subjects)

Exclusion Criteria:

* We will exclude patients taking lithium based medication
* Patients who weigh less than 40 kg; AND
* Patients who are pregnant
Natural History Clinical Study in Adult PKU

The objective of this study is to characterize the natural history of phenylketonuria (PKU) due to phenylalanine hydroxylase (PAH) deficiency in adults through prospective collection of clinical, cognitive, and quality of life assessments.

Phenylalanine hydroxylase (PAH) deficiency is a rare disease caused by an inborn error of metabolism. If left untreated, PAH deficiency results in progressive, irreversible neurological impairment during infancy and early childhood.

This study is designed to collect information about important PKU-related symptoms and tests to characterize the natural history of PKU due to PAH deficiency in a selected sample of adults. No new investigational treatment will be administered to participating patients.

Eligibility Criteria:
Key Inclusion Criteria:

* Aged 18-55 years at the time of informed consent
* Diagnosis of PKU due to PAH deficiency
* One plasma Phe value with a concentration of ≥ 600 μmol/L drawn at Screening and at least 1 historical Phe value ≥ 600 μmol/L in the preceding 12 months

Key Exclusion Criteria:

* Subjects with PKU that is not due to PAH deficiency
* Alanine aminotransferase (ALT) \> 1.5x upper limit of normal (ULN) and aspartate aminotransferase (AST) \>1.5x ULN
* Alkaline phosphatase \> 1.5x ULN
* Total bilirubin \> 1.5x ULN, direct bilirubin ≥ 1.5x ULN, unless associated with Gilbert's syndrome.
* Serum creatinine \> 1.5x ULN
* Hematology values outside of the normal range (hemoglobin \< 11.0 g/dL for males or \< 10.0 g/dL for females; white blood cells (WBC) \< 3,000/μL; absolute neutrophils \< 1,500/μL; platelets \< 100,000/μL)
* Hemoglobin A1c \> 6.5% or fasting glucose \> 126 mg/dL
* Any clinically significant abnormal laboratory result at Screening, as determined by the Investigator
Trigger- vs. Substrate-Ablation for Paroxysmal Atrial Fibrillation

The purpose of this study is to compare two strategies of catheter-based treatment of paroxysmal atrial fibrillation: Pulmonary vein isolation either alone or combined with electrogram-guided substrate-ablation.

Catheter ablation has evolved an accepted alternative in the curative treatment of atrial fibrillation (AF). However, discussion about the best ablation strategy is still ongoing.

In patients with paroxysmal AF, it has been reproducibly demonstrated that curing rates of approximately 65-70% can be achieved with the electric isolation of pulmonary veins (PV) eliminating the initiating triggers of AF episodes. Recently, a new catheter ablation approach targeting in both atria fractionated, complex electrograms during ongoing AF and modifying thus the substrate maintaining AF has been described. The first describer of this technique reports curing rates of 92%. We want to compare in a randomized prospective study the treatment by PV isolation alone with a combined approach of PV isolation together with ablation of fractionated complex electrograms in patients with paroxysmal AF. Study endpoint is the achievement of stable sinus rhythm as assessed by 7 days holter ECG in the absence of antiarrhythmic drug treatment.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 and \<80 years
* Symptomatic paroxysmal atrial fibrillation
* Drug-refractory
* Anticoagulation

Exclusion Criteria:

* Hyperthyreosis
* Moderate-to-severe mitral valve valvulopathy
* LV-ejection fraction \<35%
* Prior ablation, PCI or heart surgery \<3 months
* Left atrial thrombus
Modality of Adjuvant Radiotherapy and Chemotherapy for Stage Ⅲ Endometrial Cancer

Endometrial cancer is the most common gynecological malignancy affecting women's health. About 15% of the patients will have local late disease (stage III) with high risk of recurrence and tumor related mortality. There is a consensus that adjuvant radiochemotherapy is needed for stage Ⅲ endometrial cancer, but the best modality of radiochemotherapy is still uncertain. The retrospective data of our center showed that the sequential radiochemotherapy of "chemotherapy-radiotherapy-chemotherapy" in the "sanwich" mode could improve the survival outcome in patients with advanced endometrial cancer. A multicenter, prospective, randomized controlled study to compare the "sanwich" mode of radiochemotherapy and the "concurrent chemoradiotherapy followed by chemotherapy" mode will be carried out to determine the better modality of radiochemotherapy in stage III endometrial adenocarcinoma.


Eligibility Criteria:
Inclusion Criteria:

1. patients of primary treatment
2. All patients must have undertaken comprehensive staging operation（Surgery must have included a hysterectomy and bilateral salpingooophorectomy and surgical staging).
3. Patients with endometrial adenocarcinoma confirmed by postoperative patholog.
4. All patients with Surgical Stage III endometrial carcinoma according to FIGO 2009 staging criteria.
5. Entry into the study is limited to no more than 8 weeks from the date of surgery.
6. Patients with adequate organ function, reflected by the following parameters:

   1. WBC ≥ Normal value of the institution;
   2. Absolute neutrophil count (ANC) ≥ Normal value of the institution;
   3. Platelet count ≥ 100,000/mcl;
   4. SGOT, SGPT, and alkaline phosphatase ≤ 1.25 X upper limit of normal (ULN) ;
   5. Bilirubin ≤ 1.5 X ULN;
   6. Creatinine ≤ institutional ULN.
7. Patients with a Karnofsky score≥60.
8. The patients should voluntarily join the study, sign an approved informed consent with good compliance and cooperation with the follow-up.

Exclusion Criteria:

1. Patients who have received prior adjuvant therapy (radiotherapy or chemotherapy or endocrine therapy).
2. Patients with residual tumor after surgery.
3. Patients with other invasive malignancies.
4. Patients with contraindications of radiotherapy and chemotherapy (with a history of myocardial infarction within 3 month, unstable angina pectoris or history of uncontrolled arrhythmia s from the date of registration) and who cannot receive postoperative adjuvant radiotherapy and chemotherapy.
5. Patients with an estimated survival of less than 6 months.
6. Those who are unable or unwilling to comply with the research requirements
Cetuximab Rechallenge in Irinotecan-pretreated mCRC, KRAS, NRAS and BRAF Wild-type Treated in 1st Line With Anti-EGFR Therapy (CRICKET).

This is a multicentric, phase II single-arm study in which KRAS, NRAS and BRAF wild-type, irinotecan-resistant metastatic colorectal cancer patients progressing after an initial response to a first-line cetuximab-containing therapy, receive a rechallenge third-line treatment with cetuximab plus irinotecan.


Eligibility Criteria:
Inclusion Criteria:

* Histologically proven diagnosis of colorectal adenocarcinoma;
* RAS and BRAF wild-type status;
* First-line irinotecan-based (FOLFIRI or FOLFOXIRI) cetuximab-containing therapy producing at least a partial response;
* First-line progression-free survival in response to cetuximab-containing therapy ≥6 months;
* Documentation of progression to first-line cetuximab within 4 weeks after last cetuximab administration;
* Time between the end of first-line therapy and the start of third-line treatment with cetuximab plus irinotecan ≥4 months;
* Second-line oxaliplatin-based (FOLFOXIRI, FOLFOX or XELOX) bevacizumab-containing therapy;
* Documentation of progression to second-line treatment;
* Measurable disease according to RECIST criteria v1.1;
* Have tumor tissue (of primary tumor and metastases or at least one of the two) available for biomarker analysis;
* Male or female patients \> 18 years of age;
* ECOG Performance Status ≤ 2;
* Life expectancy of at least 3 months;
* Adequate bone marrow, liver and renal function assessed within 14 days before starting study treatment;
* Women of childbearing potential must have a negative blood pregnancy test at the baseline visit. For this trial, women of childbearing potential are defined as all women after puberty, unless they are postmenopausal for at least 12 months, are surgically sterile or are sexually inactive;
* Subjects and their partners must be willing to avoid pregnancy during the trial and until 6 months after the last trial treatment. Male subjects with female partners of childbearing potential and female subjects of childbearing potential must, therefore, be willing to use adequate contraception as approved by the investigator, such as a two-barrier method or one-barrier method with spermicidal or intrauterine device. This requirement begins 2 weeks before receiving the first trial treatment and ends 6 months after receiving the last treatment;
* Signed informed consent obtained before any study specific procedure.

Exclusion Criteria:

* Active uncontrolled infections or active disseminated intravascular coagulation;
* Past or current history of malignancies other than colorectal carcinoma, except for curatively treated basal and squamous cell carcinoma of the skin cancer or in situ carcinoma of the cervix;
* Fertile women (\< 12 months after last menstruation) and men of childbearing potential not willing to use effective means of contraception
* Women who are pregnant or are breastfeeding;
* Previous grade 3/4 infusion related reaction to cetuximab.
Therapy of Metastatic Breast Cancer With Paclitaxel and Liposomal Doxorubicin

Today metastatic breast cancer is regarded as cureless. The treatment is palliative in intent and the goals of treatment include improvement of quality of life and if possible prolongation of life. Treatment in metastatic cancer will usually involve hormone therapy and/or chemotherapy. Weekly application of chemotherapeutical drugs may lead to less drug concentrations in healthy tissue and therefore toxicities maý be reduced.

Breast cancer is the most common malignancy of females. In Germany about 46,000 women come down with breast cancer yearly.

Present therapies cannot cure the metastatic disease, the main focus is improvement of quality of life and prolongation of life. It is therefore necessary to test new substances and/or new combinations and therapy concepts. Among the most active cytotoxic agents used in advanced breast cancer are the anthracyclines. Since conventional anthracyclines are often used as adjuvant or neoadjuvant therapy their cardiotoxicity restricts their use in the therapy of the advanced disease.

Liposomal encapsulated doxorubicin shows better activity than conventional doxorubicin combined with reduced cardiotoxicity.

Weekly applied cytotoxic agents show a better toxicity profile and hence the cumulative dosis can be increased. It is expected that the combination of liposomal encapsulated doxorubicin with paclitaxel given weekly shows improved results in the therapy of metastatic breast cancer.

Eligibility Criteria:
Inclusion Criteria:

* Women \>/= 18 years with histologically proven metastatic breast cancer
* No prior chemotherapy in the advanced situation
* ECOG \</= 2
* Adequate bone marrow reserve
* left ventricular ejection fraction (LVEF) \>/= 50, measured within 4 weeks before study treatment
* Existence of written informed consent

Exclusion Criteria:

* Previous high dose therapy with stem cell support
* Prior adjuvant treatment with cumulative anthracycline dose of 600 mg/m² Epirubicin, 300 mg/m² Doxorubicin, 80 mg/m² Mitoxantrone
* Concomitant hormon- or chemotherapy or radiation therapy
* Her2/neu overexpression
* pregnancy or breast feeding
Multicentre, Double-blind Study Versus Placebo on Impact and Safety of Extramel® 140 IU on Perceived Stress, Physical and Intellectual Fatigue, Pain Perception if Present, and the Impact on the Quality of Life

Objectives of this Multicentre, double-blind study versus placebo were to evaluate impact and safety of the daily administration of Extramel® 140 IU SOD for 12 weeks on perceived stress, physical and intellectual fatigue, pain perception, if present, and the impact on the quality of life of 70 subjects included with 60 that can be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Male or female person using an effective contraceptive method, with a negative urine pregnancy test on the inclusion visit for the women of reproductive age.
* Older than 30 years and younger than 65 years
* BMI ≤ 30
* Score greater than 30 on the Cohen perceived stress scale PSS 14.
* Score between 5 and 20 in the Hamilton anxiety scale (excluding the limits).
* Presenting an impact of stress on at least one of the following domains.

  * pain domain with a score greater than 20 millimeters measured on the visual pain evaluation scale,
  * physical condition domain with a score greater than 50 on the Prevost subjective fatigue scale,
  * the psychical condition domain with a global score below 160 in the Stroop test and the reverse Stroop test.
* Stable professional activity since at least 1 year.
* Completely healthy on the day of inclusion, and not taking any medicinal product or dietary supplement with an anti-stress or anti-pain objective.
* Not taking any herbal tea or drink with an anti-stress or anti-pain objective.
* Accepting not to modify his/her dietary habits.
* Having given his/her free, informed and express consent.
* Capable of understanding the nature of the objectives, the consequences of the study and accepting to comply with the protocol requirements.
* Affiliated with a social security insurance or beneficiary of such an insurance system.

Exclusion Criteria:

* Subject presenting an acute pain or pain considered to be incapacitating by the patient him/herself or the observer physician.
* Subject currently under a chronic or acute treatment indicated for stress or anxiety, irrespective of the treatment.
* Subject currently under a chronic or acute treatment indicated for pain problems, irrespective of the treatment.
* Pregnant and/or breast-feeding women.
* Any person who does not satisfy by definition the inclusion criteria.
* Adult protected by the law.
* Any history of psychiatric disease.
* Any pathology in progress or active in the previous month.
* Any administration of a dietary supplement in progress or in the previous month.
* Any subject who within the 3 months following inclusion is likely to experience a major modification of his/her life rhythm (For example marriage, birth of a child, scheduled hospitalization, important exam, etc.) this is left to the discretion of the investigator.
Medication Adherence With Telehealthcare Medication Therapy Management

Improving Medication Adherence with Telehealthcare Medication Therapy Management to Change Health Outcomes in Adolescents and Young Adults with Asthma (MATCH) is a multi-center, randomized parallel group study targeted to an at-risk population of Adolescents and Young Adults (AYA) with uncontrolled asthma who have poor adherence with prescribed Inhaled corticosteroid (ICS) therapy.

The study evaluates a Medication Therapy Management (MTM) video telehealthcare intervention to address poor medication adherence. In addition, it employs a novel method to track and provide feedback to participants on adherence by using Propeller Sensors. 300 adolescents and young adults will be randomized to Medication Therapy Management (MTM) video telehealthcare plus electronic adherence self-management \[MTM EAM\] or electronic adherence self-management alone (EAM). Due to the hierarchal design of the trial, two primary outcomes to be tested in a sequential manner are specified, adherence and time to first asthma exacerbation.

Eligibility Criteria:
Inclusion Criteria:

* Age 12 through 35 years
* Speaks English or Spanish
* Physician diagnosed asthma (without any other co-morbid pulmonary disease)
* Prescribed ICS treatment for at least 3 months prior to screening
* Adherence to Refills and Medication Scale (ARMS) 7-item questionnaire score of \>8 (low or moderate adherence)
* Current use of albuterol metered dose inhaler (MDI) for rescue: ProAir, Ventolin, albuterol sulfate (from Prasco or Teva)
* Uncontrolled asthma:
* Symptomatic asthma defined as 3 of the following in the past 4 weeks:
* Daytime symptoms of asthma more than twice per week
* Any night awakening due to asthma
* Rescue inhaler use for symptoms more than twice per week
* Any activity limitation due to asthma; OR
* Asthma Control Test score ≤19
* Has iPhone or Android smart phone with Short Message Service (SMS)
* Has access to reliable WiFi service and a device with capability for telemedicine study visits
* Ability to understand and willingness to sign consent documents
* Evidence of Propeller sensor connection in the 4-week run-in period

Exclusion Criteria:

* Use of an investigational treatment in the previous 30 days.
* Previous enrollment in MATCH Structured Interviews ( Aim 1)
* Currently enrolled in an intervention trial
* Currently uses an ICS not compatible with the Propeller sensor
* Inability to comply with study procedures, including:
* Inability or unwillingness to provide informed consent (or assent in the case of a minor).
* Inability to perform study measurements.
* inability to be contacted by phone via calls and /or text messaging
* Not willing to have video chat
* Any condition(s) in the opinion of the physician that puts the participant at risk from participating in the study
Efficacy and Safety Study of Panobinostat in Participants With Metastatic Hormone Refractory Prostate Cancer

This Phase II single dose study was designed to characterize the safety, tolerability, and efficacy of intravenous (i.v.) panobinostat as a single-agent treatment in participants with hormone refractory prostate cancer.


Eligibility Criteria:
Inclusion criteria:

* Confirmed diagnosis of adenocarcinoma of the prostate
* Participants with metastatic hormone refractory prostate cancer
* Participants that have had at least one, but not more than two prior cytotoxic treatments for prostate cancer
* Evidence of disease progression by at least one of the following:

  1. two or more lesions on bone scan
  2. progressive measurable disease
  3. two documented increases in prostate-specific antigen (PSA)
* Willing to use contraception throughout the study and for 12 weeks after study completion

Exclusion criteria:

* History or clinical signs of central nervous system (CNS) disease
* History of other cancers not curatively treated with no evidence of disease for more than 5 years
* Prior radiotherapy within 3 weeks of starting study treatment
* Prior radiopharmaceuticals (strontium, samarium)
* Impaired cardiac function
* Heart disease
* Liver or renal disease with impaired function

Other protocol-defined inclusion/exclusion criteria may apply.
Treatment for Patients With Gynecological Malignancies Who Suffer From Anemia Due to Chemotherapy

The purpose of this study is to validate a Patient Satisfaction Questionnaire for Anemia Treatment (PSQ-AT) in gynecological cancer patients treated with darbepoetin alfa or recombinant human erythropoietin (rHuEPO) for anemia due to chemotherapy.


Eligibility Criteria:
Inclusion Criteria: - Subjects receiving multi-cycle chemotherapy for gynecological cancer - Anemia due to chemotherapy (hgb less than or equal to 11.0 g/dL) - Expected to receive greater than or equal to 8 additional weeks of chemotherapy as part of their planned treatment - Karnofsky Performance Scale (KPS) greater than or equal to 50% - Adequate renal function - Adequate liver function Exclusion Criteria: - Iron deficiency - Known positive test for human immunodeficiency virus (HIV) infection
Physical Activity Pathological Gamblers

Gambling Disorder (GD) is defined as the recurrent and persistent act of betting which leads to clinical impairments,. The latest edition of the Diagnostic and Statistical Manual of Mental Disorders (5th edition) conceptualizes GD as a behavioral addiction due to the similarities between GD and substance addictions in clinical presentation, association with personality factors, genetic transmission and treatment options. Previous studies found potential benefits of physical activity in treatment of addictions in general and GD in particular, such as reducing desire to play, betting and depressive and anxious symptoms.

Detailed Description: The purpose of this study is to investigate the effects of regular physical activity controlled and supervised in the treatment of gambling disorder with focus on gambling severity, psychiatric comorbidity and impulsiveness. Patients will undergo physical activity either running (experimental) or stretching (control) groups,. Physical activity sessions will be lead by a physical educator., Both groups will receive treatment for psychiatric comorbidities and cognitive behavioral psychoeducation.

Eligibility Criteria:
Inclusion criteria:

* Five or more diagnostic criteria for pathological gambling specified in the Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV-TR - APA, 2000);
* At least four years of formal education;
* Able to perform physical activity;
* Non-pregnant.

Exclusion criteria:

* Clinical pathology that demands urgent care such as hospitalization in another service;
* Any cardiorespiratory, musculoskeletal, or clinical condition that could prevent the practice of aerobic activity, established in clinical evaluation prior to randomization;
* Psychotic disorder that may undermine validity of responses to the self-report scales administered;
* Condition which affects the central nervous system and seriously impairs cognitive functions, as a disorder oligophrenia;
* Diagnosis of moderate to severe depression that compromises engagement in physical activity.