cyrilzakka/clinical-trials huggingface dataset:
Well Being and Rehabilitation in Chronically Ill Patients: Structured Patient Education and Physical Exercise

This study addresses self management and maintenance of health through evaluation of a program of patient education in combination with physical training and with a structured follow-up.

It is hypothesized that such a program will:

1. improve quality of life, physical functioning, coping in everyday-life
2. reduce hospitalization and (re-)admissions for patients with chronic disease, reduce consumption of home care services and can increase consumption of general practice and physiotherapy services in primary health care.
3. improve patient satisfaction and health care providers satisfaction

Patients with chronically, long-lasting illness, have complex needs for treatment and care, which none of the service providers can fulfill on their own. Both patients and their relatives are in danger of experiencing severe lack of quality. Integrated care path programs are increasingly put into use. There is insufficient research-based documentation of the effect of such care paths.

The available documentation of different integrated care paths emphasizes early mobilization and discharge, rehabilitation in familiar surroundings, more effective communication and exchange of competence between the different service providers and educational self-management for patients as main elements in order to expect effect.

There are no studies that evaluate the effect of quality of life, functional skills and personal coping if group-based educational self management is combined with physical exercise and patients with different chronically illnesses participate in the same group.

Eligibility Criteria:
Inclusion Criteria:

* 45 years of age or more
* Living at home
* Capable of active participation in a group setting
* Walking distance within 550 meter in 6 minutes
* Chronic obstructive pulmonary disease (COPD) I-III
* Chronic heart disease I-III
* Stroke(0-2 on Modified Rankin Scale)

Exclusion Criteria:

* Speaking and language problems or other substantial communication problems
* Unstable medical or social situation
* Participation in another science study
Electrical Stimulation of the Quadriceps and Diaphragm in Critically Ill Patients

Subjects in MV will be included, divided into 3 groups: (a) Control Group (CG), (b) Stimulation of Quadriceps (Quadriceps Group - QG), (c) Stimulation of Diaphragm (Diaphragm Group - DG). The QG and DG patients will receive consecutive daily electrical stimulation sessions at specific points from the first day of randomization until ICU discharge. Respiratory and peripheral muscle strength, MV time, length of hospitalization and functional independence score (the Functional Status Score-ICU) will be recorded.

Objective: Evaluate the effectiveness of the Neuro Muscular Electrical Stimulation therapy in quadriceps versus diaphragm subjects on mechanical ventilation (MV). Subjects in MV will be included, divided into 3 groups: (a) Control Group (CG), (b) Stimulation of Quadriceps (Quadriceps Group - QG), (c) Stimulation of Diaphragm (Diaphragm Group - DG). The QG and DG patients will receive consecutive daily electrical stimulation sessions at specific points from the first day of randomization until ICU discharge. Respiratory and peripheral muscle strength, MV time, length of hospitalization and functional independence score (the Functional Status Score-ICU) will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* Age of 18 years or more
* 24 hours of MV or more

Exclusion Criteria:

Hemodynamic instability, pregnancy, body mass index(BMI) \>35 kg/m2, history of neuromuscular disease at admission, brain death, diseases with systemic vascular involvement, bone fractures, use of an internal or external fixator, skin lesions, end-stage cancer, use of pacemakers, spinal injuries, or inability to receive an Medical Research Council score because of the cognitive state.
Role of Rehabilitation for the Repair of Pelvic Floor Injuries Associated to Vaginal Delivery Identified by 3/4D Transperineal Ultrasound

SUMMARY: (Objective, design, scope of the study, subjects of study, instrumentation, results, conclusions)

Objectives: To evaluate if the physiotherapy treatment in pelvic floor dysfunctions, identified by transperineal ultrasound 3 / 4D, in postpartum improve the tone and functionality of pelvic floor.

Design: Post-authorization, prospective, longitudinal randomized intervention study

Scope: Full-term deliveries at the University Hospital. Subjects of study: Full-term primiparous and full-term pregnancies with pelvic floor lesion, identified by transperineal ultrasound 3 / 4D, which are randomized between the physiotherapy treatment of pelvic floor and the non-work.

Variables: Primary variable: Assess the improvement in contractility / tone, evaluation by manometry and assess the anatomical improvement of the area of ?? the genital hiatus, stay by transperineal ultrasound 3 / 4D. Secondary variables: Identify the levator ani muscle injury rate, estimate the sonographic changes in the levator ani muscle through rehabilitation. Analyze the improvement of the symptoms associated with the public organic prolapse and evaluate the improvement of the quality of life.

Data analysis: To detect a difference of 10% in the reduction of the size of the index between the study groups (not intervened / intervened) after 6 months of intervention, standard deviation 10%, Error-alpha 5%, Error- beta 10% (P90%) we need 23 women in each group. Assuming a loss of 10% in the follow-up, the final size would be 52 women, 26 per group.


Eligibility Criteria:
Inclusion Criteria:

* Vaginal delivery
* Cephalic presentation
* Primiparity
* At term gestation (37-42 weeks)
* No prior pelvic floor corrective surgery
* Written informed consent

Exclusion Criteria:

* Pregnancies with severe maternal or fetal pathology
Pilot Study to Compare ISOVUE®-250 and VISIPAQUE™ 270 for Motion Artifact and Pain in Peripheral DSA

The purpose of this study is to compare ISOVUE-250 and VISIPAQUE 270 for motion artifact and pain following intraarterial injection for peripheral DSA.


Eligibility Criteria:
Inclusion Criteria:

Enroll a patient in this study if the patient meets the following inclusion criteria:

* Provides written Informed Consent and is willing to comply with protocol requirements;
* Is at least 18 years of age;
* Is scheduled to undergo peripheral DSA for the diagnosis and/or treatment (PTA) of PAOD.

Exclusion Criteria:

Exclude a patient from this study if the patient does not fulfill the inclusion criteria, or if any of the following conditions are observed:

* Is a pregnant or lactating female. Exclude the possibility of pregnancy:
* by testing on site at the institution (serum or urine βHCG) within 24 hours prior to the start of investigational product administration,
* by surgical history (e.g., tubal ligation or hysterectomy),
* post menopausal with a minimum 1 year without menses;
* Has any known allergy to one or more of the ingredients of the investigational products;
* Has a history of severe congestive heart failure \[class IV in accordance with the classification of the New York Heart Association (NYHA)\]
* Was previously entered into this study or received an investigational compound within 30 days before admission into this study;
* Has a history of hypersensitivity to iodinated contrast agents;
* Has renal impairment (eGFR \<60 mL/min/1.73 m2, calculated using the Modification of Diet in Renal Disease \[MDRD\] study equation , );
* Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or postdose follow-up examinations.
Trial of LAVA-051 in Patients with Relapsed/refractory CLL, MM, or AML

A phase 1, first-in-human trial to evaluate the safety and tolerability of LAVA-051 in patients with relapsed or refractory Chronic Lymphocytic Leukemia (CLL), Multiple Myeloma (MM), or Acute Myeloid Leukemia (AML).

An open-label, phase 1 dose escalation trial with disease-specific expansion cohorts to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary anti-tumor activity of LAVA-051 in patients with relapsed or refractory CLL, MM, or AML.

The trial was intended to be a Phase 1/2 trial (but the trial never moved forward to Phase 2).

Eligibility Criteria:
KEY INCLUSION CRITERIA

1. Patient must be 18 years of age inclusive or above at the time of signing the informed consent.
2. Patients with documented diagnosis of relapsed or refractory CLL, MM, or AML who have failed to respond to or who have relapsed after prior therapy and are not amenable to standard treatments or for whom no standard treatments are available.
3. Predicated life expectancy of ≥ 3 months.
4. ECOG performance status of 0 or 1.
5. Males or non-pregnant, non-breastfeeding females who are either:

   1. Surgically sterile.
   2. Female of childbearing potential with a negative pregnancy test and compliant with an effective contraceptive regimen.
   3. Female, postmenopausal.
   4. Male compliant with an effective contraceptive regimen.
   5. Male refraining from donating sperm.
6. Capable of giving signed and dated informed consent prior to initiation of any trial-related procedures.

KEY EXCLUSION CRITERIA

1. Prior allogeneic bone marrow transplant if the patient still has active acute or chronic graft versus host disease requiring \>10 mg prednisone or equivalent corticosteroids.
2. Concomitant malignancies except carcinoma in situ, basal or squamous cell skin carcinoma. Patients who had no evidence of disease from another primary cancer for 2 or more years are allowed to participate in the trial. Localized non-metastatic prostate cancer, not requiring systemic treatment, and for which no local treatment is planned, is allowed.
3. Uncontrolled or severe intercurrent medical condition.
4. Previous treatment with an aminobisphonsphonate IV (e.g. ibandronate, pamidronate, zoledronate) within 4 weeks prior to initial IMP administration.
5. Known ongoing drug or alcohol abuse in the opinion of the investigator.
6. Previous autologous haematopoietic stem cell transplantation (HSCT) or treatment with Chimeric Antigen Receptor (CAR) T-cell therapy within 6 months prior to initial IMP administration.
7. Immunodeficiency disorders.
8. Patients with Richter's transformation are excluded.

Other eligibility criteria will apply during full screening.
Neurocognitive Effects of Buprenorphine Among HIV+ and HIV-Opioid Users

The purpose of this study is to examine how Buprenorphine, a form of opioid addiction treatment, changes the ability to think and reason among people addicted to opiates, who are either HIV negative or HIV positive. In addition, blood samples will be stored for HIV+ and HIV- individuals who take buprenorphine to study its effect. This study hypothesizes that the HIV positive participants will demonstrate significant improvement in thinking and reasoning ability at 3 and 6 months compared to baseline, but that their thinking and reasoning ability will still be lower than HIV negative participants. This study also hypothesizes the biomarkers in participants' blood samples will be associated with measures of change in thinking and reasoning ability.


Eligibility Criteria:
Inclusion Criteria:

* Documented HIV-serostatus
* English-speaking
* Age 18-60
* Able to give voluntary, signed informed consent
* Plan to initiate buprenorphine treatment in the next month.

Exclusion Criteria:

* Over age 60: Participants over the age of 60 will be excluded, as normal age-associated cognitive changes may confound neuropsychological (NP) assessment and diagnosis of HIV-related cognitive disorders.
* Neurologic: History of head injury with loss of consciousness for greater than 12 hours; previous penetrating skull wounds; previous brain surgery; known seizure disorder, or any other non-HIV related CNS disorders that might affect neurocognitive functioning (e.g., previous cerebrovascular accident, Parkinson's disease, multiple sclerosis, brain tumor).
* Medical: e.g. collagen vascular disorder (e.g. lupus), oxygen requiring chronic pulmonary disease,, or end stage renal disease requiring dialysis.
* Psychiatric: Lifetime diagnosis of schizophrenia or bipolar disorder.
* Less than 6 years of education.
* Acute intoxication due to alcohol or other drugs, as assessed by research staff.
* Use of buprenorphine in the past month, either prescribed or purchased on the street.
The Analysis of Chinese Medical Syndromes Differentiation on Acute Ischemic Stroke

Background and objective: Stroke, which means sudden onset of cerebral vascular accident. The earliest document was found in "Neijing". The ancient physicians had different opinions and points of view on the etiology and pathogenesis of stroke. Before the Tang and Song dynasty, the "exopathic wind" theory was talked about. And, after then, the "endogenous wind" theory was put forward. While in the Ming dynasty, Zhang Jing-Yue advocated that "Stroke is not caused by wind etiology'', highlighting the much difference of the thinking. Until nowadays, many famous physicians have their own unique way to determine the etiologic factor based on differentiation. To be practical, objectivity differentiating and determining the etiologic factor of stroke is the foundation of establishing the treatment guidelines. The investigators aim to establish the scientific epidemiological standard of traditional Chinese Medicine (TCM) syndromes of acute ischemic stroke in Taiwan.

Methods: The investigators use the ischemic stroke TCM syndromes Diagnostic Scale (ISTCMDS) and the Meridian Energy Analysis Device (M.E.A.D.) to objectively analyze the diagnostic elements and detect the deficiency or excess performance of meridians of acute ischemic stroke patients from Stroke Center at Linkou Chang Gung Memorial Hospital. The onset of stroke is set Within 7 days, and the investigators expected to collect 300 patients. The investigators initially establish the scientific epidemiological study of acute ischemic stroke with TCM syndromes and deficiency or excess of meridian performances through statistical analysis to become a standard of Chinese and Western medicine integration. The data collection can gradually become a library, which will facilitate the assessment of the clinical efficacy of TCM adjuvant therapy and become a basis to assist Western and Chinese medicine integration.

Eligibility Criteria:
Inclusion Criteria:

* Patient with acute ischemic stroke, approved by brain CT or MRI
* Onset within 7 days
* No other severe organic diseases
* Stroke for the first time or recurrent stroke with previous Rankin's scale ≦1 status
* Signed Inform Consent

Exclusion Criteria:

* Not meet the above diagnostic and inclusion criteria
* Complicated with sepsis or other infections
* Refuse to accept Chinese Medical syndromes differentiation, the Meridian Energy Analysis Device (M.E.A.D.), or refuse to sign Inform Consent
* Unconsciousness
* With pacemaker or pregnancy
Relationship of Proprioception, Reaction Time and the Gait and Balance Parameters After Stroke

The aim of this observational study is to analyze how impaired proprioception affects the gait, reaction time, balance and functioning of stroke patients.

Research questions:

* Are there correlations between the deficit of proprioception and reaction time and the parameters of gait and balance as well as the functional state of stroke patients?
* Are there relationships between factors such as proprioception, reaction time, balance, functional status and gait, and time since stroke, the hemisphere where the stroke occurred, and gender?
* Are there differences in proprioception deficits and reaction times between the lower limbs in stroke survivors?

Participants will be assessed once using standard functional clinical tests and the rehabilitation devices.

Researchers will compare stroke patients and healthy volunteers to see, if there are differences in proprioception deficits, reaction time and balance.

For this prospective observational study, 50 ischemic - stroke survivors (study group) and 50 healthy volunteers matched for age and gender (control group) will be recruited. Study procedures will be performed in the morning including one-time functional assessment of proprioception, gait, balance and reaction time using standard clinical tests (Timed Up and Go Test, sit to stand test, 10m walk test, Wisconsin scale, Berg scale, Ashworth scale, Brunstrom scale, Barthel Scale, Rankin scale and FAC) and rehabilitation devices (Luna EMG - proprioception assessment, Pablo - gait parameters assessment, Omego Plus - proprioception assessment, ALFA stabilometric platform - balance and reaction time assessment).

Eligibility Criteria:
Inclusion Criteria:

* informed and voluntary consent of the patient,
* first-time stroke,
* hemiparesis,
* time from stroke to 3 months,
* age 30-75,
* grade 3-5 in the Functional Ambulation Category,
* walking without orthopedic support.

Exclusion Criteria:

* lack of informed and voluntary consent of the patient,
* second or subsequent stroke,
* stroke of the brainstem and cerebellum,
* epilepsy,
* disorders of higher mental functions,
* coexisting neurological, rheumatological, orthopedic diseases,
* use of orthopedic supplies during locomotion.
Vascular Mechanisms for the Effects of Loss of Ovarian Hormone Function on Cognition in Women

Complaints about memory and thinking are common in women as they go through menopause and estrogen levels fall. The ovarian hormone estrogen is important for supporting normal cognitive function, and changes in brain activity and function occur when estrogen levels are decreased. Estrogen is also important for maintaining healthy blood vessels which also support normal cognitive function. In Alzheimer's disease and other types of dementia, there is significant damage to the blood vessels in the brain. This study will test whether changes in brain activity and function with the loss of estrogen are related to changes in vascular function. The investigators will measure vascular function using ultrasound, and brain activity using MRI scans in women who are enrolled in the Females, Aging, Metabolism and Exercise (FAME) study (NCT01712230). In the FAME study, healthy premenopausal women either take a medication to decrease their estrogen levels, or a placebo. This sub-study may provide new information about how estrogen affects vascular function and cognitive function, and lead to new ways to prevent or delay cognitive impairment or dementia.


Eligibility Criteria:
Inclusion Criteria:

1. Volunteers will be healthy women aged 40 to 60 years
2. Are enrolled in the parent FAME study (NCT01712230).

The Investigators will consent up to 80 subjects with the aim of enrolling 17 in each of the 2 groups (placebo, GnRH agonist).

Exclusion Criteria:

1. mini-mental state examination (MMSE) score 27 or less
2. history of neurologic disease or major psychiatric illness
3. major depressive episode within the past 12 months
4. history of learning disability
5. less than high-school education
6. current smoking
7. use of psychoactive medications in the past 3 months (stable use of anti- depressant medication is allowed)
8. contraindications to MRI scanning
Granulocytapheresis in Psoriasis

In a prospective, randomized, controlled, double-blinded, multicenter study, granulocytapheresis using a novel cellulose-based adsorber will be compared to control sham treatment (placebo). The effects on clinical symptoms and on some inflammatory parameters of patients with moderate to severe plaque psoriasis will be evaluated over a 24-week period.

The primary end-point is a ≥75 percent improvement in PASI (Psoriasis Area and Severity Index).

The study purpose is to demonstrate a beneficial therapeutic effect of granulocytapheresis using the novel cellulose-based adsorber device in moderate to severe plaque psoriasis.


Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe plaque psoriasis with a PASI \>/=10
* Age \>/= 18 years
* Negative pregnancy test in woman of childbearing age acceptable method of contraception for both men and women
* Written informed consent that can be withdrawn at any time or for any reason
* Discontinuation of any systemic psoriasis treatment. Washout period of at least two weeks for prior systemic medications
* Only emollients for topical treatment
* No vaccinations for at least 14 days prior to first treatment

Exclusion Criteria:

* Other forms of psoriasis (e.g., guttate, pustular, erythrodermic, palmoplantar etc.)
* History of ongoing uncontrolled bacterial, fungal or viral infection (including opportunistic infections); HIV positivity
* Pregnancy
* Clinically relevant thrombocytopenia or bleeding disorders
* WBC \<4.000 or \>12.000/µl
* Malignancy within the last five years (exception: successfully treated basal cell carcinoma or squamous cell carcinoma of the skin)
* Severe cardiac disorders, stroke, pulmonary disease within the last year
* Any medical condition that, in the judgment of the investigators, would jeopardize the patient's safety during the study
Bipolar Disorder in Epilepsy

The purpose of this study is to find out how often major mood swings occur in patients treated in a specialty epilepsy center.

Bipolar disorder (a condition of major mood swings) or milder forms of ups and downs in mood may occur with a number to neurological conditions. Recently, one study showed that these mood changes occur fairly often in individuals with epilepsy studied in the general community. We speculate that bipolar symptoms occur with even higher frequency in a tertiary epilepsy center than that encountered in the previous community-based study. The goals of this study are to assess:

* the rate of bipolar symptoms as measured by a self-reporting screening tool in a tertiary epilepsy center setting
* the meaning of a positive screening score in epilepsy patients
* the utility, sensitivity and specificity of alternative screening tools for mood instability in epilepsy patients
* the correlation of mood instability with seizure-related variables
* the relation of a positive screening score on quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Male or female 18 years of age or older
* Being evaluated at the Long Island Jewish Comprehensive Epilepsy Center
* Capable of completing self-reporting questionnaires

Exclusion Criteria:

* Patients with mental retardation
* Patients with pseudoseizures
Lidocaine Infusion in Hystroscopy

Lidocaine infusion in hystroscopic media versus oral diclofenac


Eligibility Criteria:
Inclusion Criteria:

* Age 18-35 years
* BMI 18.5-30 kg/m2
* Diagnostic hystroscope

Exclusion Criteria:

* Previous cervical surgery
* Cervical stenosis
* PID
* allergy to NSAID
* Gastritis or peptic ulcer