cyrilzakka/clinical-trials huggingface dataset:
Irofulven in Treating Patients With Persistent or Recurrent, Refractory Endometrial Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of irofulven in treating patients who have persistent or recurrent refractory endometrial cancer.

OBJECTIVES: I. Assess the antitumor activity of 6-hydroxymethylacylfulvene in patients with persistent or recurrent, refractory endometrial carcinoma. II. Determine the nature and degree of toxicity of this treatment in these patients.

OUTLINE: This is a multicenter study. Patients receive 6-hydroxymethylacylfulvene IV over 5 minutes on days 1-4. Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: Approximately 19-51 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed endometrial carcinoma refractory to curative therapy or established treatments Clinically or histologically confirmed persistent or recurrent disease Bidimensionally measurable disease (ascites or pleural effusions not considered measurable) Not eligible for higher priority GOG protocol

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: GOG 0-2 Life expectancy: Not specified Hematopoietic: Platelet count at least 100,000/mm3 Absolute neutrophil count at least 1,500/mm3 Hepatic: Bilirubin normal Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance greater than 60 mL/min Cardiovascular: No clinically uncontrolled dysrhythmia or signs of ischemia per ECG No congestive heart failure requiring medication No uncontrolled hypertension Other: No significant active infection No other prior or concurrent malignancy within the past 5 years except nonmelanomatous skin cancer

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 3 weeks since prior chemotherapy and recovered No more than 1 prior chemotherapy regimen allowed (either single or combination cytotoxic drug therapy) No prior 6-hydroxymethylacylfulvene No prior chemotherapy for other malignancy Endocrine therapy: Not specified Radiotherapy: At least 3 weeks since prior radiotherapy and recovered No prior radiotherapy for other malignancy Surgery: At least 3 weeks since prior surgery and recovered
Personal Variables Affecting the Successful Aging

Three hundreds patients aged 60 years and older applicant for any reasons between January 3, 2019 and May 30, 2019, in Health Sciences University Haydarpaşa Numune Training and Research Hospital Family Medicine Polyclinics. A 21-item questionnaire including demographic information was asked to the individuals who gave consent to participate in the study, voluntarily, and who met the participation criteria and the Successful Aging Scale was administered face-to-face with the questionnaire method. Participants were evaluated under two subheadings according to the Successful Aging Scale and the results were compared with their demographic characteristics.

In our cross-sectional study; the target sample size was calculated as 299, with a population of 1350. The prevalence was 50%, the standard error was 5% in a 95% confidence interval. Between 03.01.2019 and 30.05.2019; 300 elderly volunteers who applied to the Health Sciences University Haydarpaşa Numune Training and Research Hospital Family Medicine Polyclinics for any reason, who were not diagnosed with neuropsychiatric disease, do not had physical or mental problems that would prevent them from understanding and filling the scales and do not have a health problem that require urgent intervention are included. Participants were informed, their consent was taken, and a 21-item sociodemographic form prepared by the researchers was applied. Afterwards, a 7-point Likert-type "Successful Aging Scale" (SAS) consisting of 10 questions was applied to the participants.16 The scale had two sub-components, namely "healthy lifestyle" (HL) and "adaptive coping" (AC). The values of the expressions in the scale were as "strongly agree:7, agree:6, partially agree:5, undecided:4, partially disagree:3, disagree:2, strongly disagree:1". The values for each individual were summed up and the scale was evaluated by subtracting the total score. Finally, the results from the questionnaire and the Successful Aging Scale were compared and analyzed according to subcomponents.

Eligibility Criteria:
Inclusion Criteria:

* Not having received a diagnosis of dementia at any stage of life.
* Not having any cognitive or physical impediments that hinder understanding and completing the scales.
* Having full orientation and cooperation.
* Having completed the scales in their entirety.
* The absence of symptoms or diseases requiring urgent intervention.
* Voluntarily participating in the study and having signed the informed consent form after being informed.

Exclusion Criteria:

* Having received a diagnosis of dementia.
* Having cognitive and physical impediments that hinder understanding the scales.
* Lack of full orientation and cooperation.
* Having a clinically significant diagnosis of an active psychiatric disorder.
* having symptoms of a situation requiring urgent intervention.
A Phase III Trail of Adjuvant Chemoradiotherapy Versus Adjuvant Radiotherapy in Esophageal Squamous Cell Carcinoma

This is a multicenter, randomized, open-label, phase III trail comparing adjuvant chemoradiotherapy (Paclitaxel and carboplatin) to adjuvant radiotherapy in patients undergoing radical esophagectomy for pathologic lymph node positive esophageal squamous cell carcinoma.

Patient Population: Age: 18-70y; Thoracic esophageal squamous cell cancer undergoing radical esophagectomy; Clinical stage T1-4, N1-3, M0; Eastern Cooperative Oncology Group (ECOG) score: 0-1; The patients are randomized to 2 arms. Arm A: Adjuvant radiotherapy (50.4gray/28fraction) followed by chemotherapy (Paclitaxel and carboplatin) 4 cycles. Arm B :Adjuvant radiotherapy (50.4gray/28fraction) only

Eligibility Criteria:
Inclusion Criteria:

1. Histologically documented squamous cell carcinoma of the thoracic esophagus; undergoing radical esophagectomy; the pathological stage is T(primary tumor)1-4 N(regional lymph nodes)1-3 M(distant metastasis)0 (ESOPHAGUS, Union for International Cancer Control(UICC) 2010) ;
2. Untreated (e.g. radiotherapy, chemotherapy, target therapy and immunotherapy);
3. The expectation of life is more than 6 months;
4. Age: 18\~70 years old;
5. Normal hemodynamic indices before the recruitment (including white blood cell count\>4.0×109/L, neutrophil count\>1.5×109/L, platelet count \>100×109/L, hemoglobin≥90g/l, normal liver/kidney function);
6. ECOG (Eastern Cooperative Oncology Group) : 0-1;
7. Able to understand this study and have signed informed consent.

Exclusion Criteria:

1. Have been treated with chemotherapy, radiotherapy and other anti tumor treatment except surgery;
2. Known or suspected of allergy to paclitaxel or carboplatin;
3. Female in pregnancy or lactating;
4. With significant psychological, family, social and other factors which may affect the ability to understand and sign the informed consent;
5. Patients with peripheral neuropathy(CTC grade≥2);
6. With other malignant tumors before the recruitment.
7. The researchers consider that the patient is not appropriate to enroll the study;
8. The patient can't be tolerant to postoperative adjuvant radiotherapy and chemotherapy for serious heart/lung/liver/kidney function, the haematopoietic system diseases, the immune system diseases, the nervous system diseases, cachexia and so on.
Evaluation of Cognitive Functions in 20 Patients With Type 1 Myotonic Dystrophy With Virtual Reality Approach

Type 1 myotonic dystrophy (MD1) is a genetic and hereditary disease that primarily affects muscle tissue, resulting in myotonia (difficulty relaxing after contraction) and atrophy (progressive muscle weakening with decreased muscle volume). It also affects eyes, heart, endocrine system, gastrointestinal system and central nervous system. Specific cognitive abilities are impaired in patients with MD1 such as attention, visio-spatial or visio-building abilities as well as executive dysfunctions.

Currently, the cognitive assessment of MD1 patients is based on classical neuropsychological tests, which are time-consuming and require a MD1 expert neuropsychologist. Moreover, it is usually very difficult for MD1 patients to accept performing these tests, and when they agree to perform them, they usually give up before the end. This finding is more frequent in MD1 patients with high level of cognitive impairment.

In order to overcome these difficulties in assessing cognitive functions of MD1 patients, the investigators decided to use innovative tools such as virtual reality, which allow individuals to experience a sensory-motor and cognitive experience in a digitally world through a helmet, glasses and joysticks.

The start-up My Cyber Royaume from Lille, in collaboration with the reference center of neuromuscular diseases from Nice coordinated by Pr Sacconi, have developed a software "Good Diag NMD" which uses virtual reality to assess cognitive disorders, more specifically executive functions in patients with type 1 myotonic dystrophy.


Eligibility Criteria:
Inclusion Criteria:

* male or female age ≥ 18
* suffering with type 1 myotonic dystrophy confirmed by molecular biology
* suffering with dysexecutive impairments, with a pathologic BREF score ≤ 15
* affiliated to social security
* able to understand the inform consent form

Exclusion Criteria:

* suffering with visual or auditive impairments preventing them doing tests
* suffering with other pathologies preventing them doing tests
* suffering with motor impairments preventing them holding joysticks or carrying helmet
* protection by law under guardianship, or who cannot participate in a clinical study under Article L. 1121-16 of the French Code of Public Health
* patient under treatment that may affect cognitive functions (ie : Modafinil)
* participation in the last 3 months in a clinical research study in which he / she has been exposed to a pharmaceutical product or a medical device
* pregnant or breastfeeding female patient
Ultrasound-Guided Hydrodilatation With Triamcinolone Acetonide for Adhesive Capsulitis

The purpose of this study was to compare the efficacy of ultrasus-guided hydrodilation of Rotator Cuff Interval combined with Posterior Glenohumeral recess approach and hydrodilation of the Rotator cuff Interval alone in Adhesive Capsulitis.

For patients with perihumeral arthritis, shoulder capsule hydrodilation is usually performed using ultrasound-guided water dilation through the posterior glenohumeral recess. Recently, a new transrotator cuff space approach has been described, and this study was designed to compare the efficacy of triamcinolone olonide transrotator cuff space combined with posterior glenohumeral recess and rotator cuff space dilation in the treatment of adhesive joint capsitis.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years old, clinical diagnosis of periarthritis of shoulder;
2. symptom duration \> 1 month, shoulder ROM limitation in at least two directions, defined as abduction \< 80°, flexion \< 130°, and rotation \< 30°;
3. Before enrollment, the patients received plain radiographs, ultrasound images, and magnetic resonance imaging to rule out the cause of secondary shoulder capsitis.

Exclusion Criteria:

1. Secondary frozen shoulder, such as rotator cuff tear, calcifying tendinitis, osteoarthritis, infection, tuberculosis infection, rheumatic disease, shoulder impingement syndrome;
2. Previous history of shoulder joint surgery;
3. Involved cervical nervous system symptoms or abnormal nervous system;
4. corticosteroid injection in the affected shoulder within 3 months;
5. Mental illness;
6. Patients with contraindications to cortisol-hormone use.
Remote Monitoring in Patients With Heart Failure

This study is a prospective cohort study with consecutive enrollment of newly diagnosed heart failure patients, investigating the prevalence and types of arrhythmias in this high-risk population using non-invasive remote monitoring with the Coala Heart Monitor. Participants are scheduled to use the Coala Heart Monitor twice daily or during symptoms (e.g. syncope, presyncope, palpitations, chest discomfort, or shortness of breath) to record a thumb and chest ECG over 3 months. Patient compliance with the recordings, self-reported health, response to technology, and experience using the device will additionally be assessed by self-developed questionnaires and the Kansas City Cardiomyopathy Questionnaire (KCCQ) at 3 months.


Eligibility Criteria:
Inclusion Criteria:

* Owns or has access to a smartphone
* Newly diagnosed moderate to severe heart failure (NYHA II-IV and left ventricular ejection fraction ≤ 40%)

Exclusion Criteria:

* Earlier atrial fibrillation/atrial flutter with indication for oral anticoagulant (OAC) treatment
* Pacemaker
* Cardiac resynchronization device
* Indications for OAC treatment (also low molecular weight heparin) due to atrial arrhythmias, mechanical heart valve, deep vein thrombosis, or pulmonary embolism.
* Expected survival ≤ 6 months
* Absolute contraindications for starting OAC treatment
Study to Assess the Way the Body Absorbs, Distributes, Breaks Down and Eliminates Radioactive BMS-986256 in Healthy Male Participants

The purpose of this study is to assess the way the body absorbs, distributes, breaks down and eliminates radioactive BMS-986856 in healthy males.

Recruitment temporarily on hold due to COVID-19.

Eligibility Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Healthy participants, as determined by no clinically significant deviations from normal in medical history, physical examination abnormalities that would compromise the ability to participate, complete, and/or interpret the results of the study, 12-lead electrocardiograms (ECGs), vital signs, and clinical laboratory results.
* Males must agree to follow specific methods of contraception, if applicable, while participating in the trial

Exclusion Criteria:

* Any significant acute or chronic medical condition that presents a potential risk to the participant and/or that may compromise the objectives of the study
* History of any significant drug and/or food allergies

Other protocol-defined inclusion/exclusion criteria apply
New Haven MOMS Partnership

Phase II of the MOMS Partnership aims to:

1. conduct a needs assessment of the mental health of mothers residing in New Haven, CT;
2. provide on-site group intervention services (randomized by housing community) to improve signs/symptoms of depression/stress/trauma among mothers living onsite.

The purpose of this project is to expand and enhance the New Haven Mental health Outreach for Mothers (MOMs) Coalition beyond pregnancy and depression to include a broader definition of mental illness (depressive, anxiety, and substance use disorders), and a larger target population (low-income, racially and ethnically diverse, pregnant and parenting women) in the City of New Haven. Through this expansion, the Coalition will bring together the community of women, their families and advocates, healthcare providers, policy and agency leaders, and academics, to inform the development and conduct of public health approaches around the mental health of low-income, racially and ethnically diverse, pregnant and parenting women. The specific goals of this Phase I proposal are:

1. To conduct a community-led needs assessment on the mental health of low-income, ethnically and racially diverse pregnant and parenting women in the City of New Haven.
2. To provide randomized intervention services to improve signs/symptoms of depression/stress/trauma among mothers living in public housing in New Haven, CT

Eligibility Criteria:
Inclusion Criteria:

* CES-D score \>=16
* Child under the age of 18 (participant must be a mother)
* Resident of public housing authority complex in New Haven, CT or an affiliated Section 8 recipient

Exclusion Criteria:

* Positive for psychosis
* Active suicidal ideation
* Non-English or Spanish speakers
* Unable to provide informed consent
* Unwilling to accept randomization
* Moving within the intervention \& follow-up period
Laser Vision Correction Use of an Eye Shield for Maintaining Vision and Mitigating Pain

The purpose of this research is to determine if an investigational thin shield can effectively reduce discomfort following Laser Vision Correction.


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled to undergo Laser Vision Correction for correction of refractive error
* FDA approved treatment guidelines for Laser Vision Correction
* Age 18-60
* Patients able to understand the requirements of the study, willing to follow study instructions, provide written informed consent to participate, and comply with all study requirements, including the required study follow-up visits

Exclusion Criteria:

* Any other anterior segment abnormality other than that associated with LAser Vision Correction
* Any abnormalities associated with the eye lids
* Uncontrolled blepharitis or dry eye
* Prior laser treatment of the retina
* Any ophthalmic surgery performed within three (3) months prior to study excluding PRK or LASIK
* Diagnosis of glaucoma
* Active diabetic retinopathy
* Clinically significant inflammation or infection within six (6) months prior to study
* Uncontrolled systemic disease (e.g., diabetes, hypertension, etc.) in the opinion of the Investigator
* Participation in any study involving an investigational drug within the past 30 calendar days, or ongoing participation in a study with an investigational material
* Intolerance or hypersensitivity to topical anesthetics, antibiotics, steroids or any other pharmaceuticals that may be used pre and post surgically
* Specifically known intolerance or hypersensitivity to contact lenses or any component of the investigative material
* A medical condition, serious concurrent illness, or extenuating circumstance that would significantly decrease study compliance, including all prescribed follow-up
* Any condition that, in the opinion of the investigator, would jeopardize the safety of the patient
* Pregnancy
Freiburg ZNS-NHL Study

The purpose of this study is to determine whether combined chemotherapy \[rituximab plus high dosage methotrexate (max. 2 cycles) followed by arabinoside/thiotepa (max. 2 cycles) followed by high dosage carmustin/thiotepa\] followed by peripheral blood stem cell transplantation is effective in the treatment of cerebral Non Hodgkin lymphoma \[PCNSL\].


Eligibility Criteria:
Inclusion Criteria:

* group A: first diagnosis of PCNSL, histologically confirmed
* group B: relapse or progression of PCNSL after MTX containing chemotherapy
* age 18 - 65 years
* not legally incompetent, physically or mentally incapable of giving consent
* written signed and dated informed consent of the legal representative and - if possible - of the patient

Exclusion Criteria:

* manifestations of further lymphoma outside the CNS
* sero-positive for HIV
* severe pulmonary, cardiac, hepatic, renal impairment
* neutrophil count \< 2.000/µl, platelet count \< 100.000/µl
* pulmonary disease with IVC \< 55%, DLCO \< 40%
* cardiac ejection fraction \< 50%, uncontrolled malign arrhythmia
* creatinine \> 1,5 mg% or creatinine-clearance \< 50ml/min
* bilirubin \> 2mg/dl
* ascites or pleural effusion (\> 500ml)
* pregnancy o r lactation
* women with childbearing potential without sufficient contraception
* participation in another clinical trial within the last 30 days prior to the begin or parallel to this study
* known or current drug or alcohol abuse
* known hypersensitivity against methotrexate, cytarabine, thiotepa, BCNU rituximab, leukovorin, dexamethasone, neupogen and neulasta.
COGnitive ImpairmenT in Older HIV-infected Patients ≥ 65 Years Old

Despite combined antiretroviral therapy (cART), milder forms of HIV-associated neurocognitive disorders (HAND) persist in 20-50% of persons living with HIV (PLHIV). Since more PLH are at risk for HAND due to aging, the frequency of HAND in PLHIV ≥ 65 years old is important to quantify for planning early intervention to attenuate both functional and occupational disabilities due to cognitive impairment.


Eligibility Criteria:
Inclusion Criteria:

* Personal or familial cognitive complaints
* Individual aged ≥ 65 years old and \< 81 years old
* Instrumental activities of daily living (IADL) score between 3-4
* French speaking individual
* Informed consent signed For PLHIV
* HIV infection
* Undetectable HIV viral load ≥ 1 year
* Current cluster of differentiation (CD4) cell count \> 100/mm3 For controls
* negative HIV serology ≤ 6 months

Exclusion Criteria:

* Opportunistic infection \< 5 years
* Contraindications to MRI
Etoricoxib Prescribing Patterns and Adverse Events of Interest in Primary Care in the United Kingdom (MK-0663-162 AM1)

This postmarketing study was conducted to describe prescribing patterns for etoricoxib (ARCOXIA®) in General Practice and describe the incidence of selected adverse events recorded in the United Kingdom (UK) Medicines and Health Care Products Regulatory Agency (MHRA) General Practice Research Database (GPRD).


Eligibility Criteria:
Inclusion Criteria:

* All patients in the MHRA's Full Feature GPRD (FF-GPRD) who have at least one electronic outpatient prescription record for etoricoxib issued by a General Practitioner during the period (April 1, 2002 to December 31, 2015) at the date of query execution against the FF-GPRD data warehouse.

Exclusion Criteria:

* Not registered in a GPRD-contributing practice that had continuously

collected data deemed to be 'up-to-standard' for research purposes from 1 April 2002 through to 31 December 2015.

* Never registered as a permanent patient of a General Practitioner in the practice
* Registration details were not acceptable (i.e. incomplete data or logically implausible dates)
* Not registered with a General Practitioner for at least 365 days before the date that the patient's first etoricoxib prescription was recorded in the GPRD
Effects of a Low Carb Diet on Erectile Function and Serem Testosterone in Men With Metabolic Syndrome

Investigate if low carb diet could increase serum testosterone level in hypogonadic men

Randomized controlled trial to evaluate the effect of low carb diet in men with metabolic syndrome and low testosterone level. The inclusion criteria is men with metabolic syndrome and serum total testosterone below 300 ng/dL. They will randomized to perform a low carb diet or a traditional low fat diet for metabolic syndrome. The follow up will be of three months with a once a month visit. Even though these men will be looked at their sexuality and life style. They will be monitoring by urologists and nutritionists during the study.

Eligibility Criteria:
Inclusion Criteria:

* metabolic syndrome, serum testosterone level below 300 ng/dL

Exclusion Criteria:

* active cancer, diet allergies, psychological incapability