cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of Home Based Occupational Therapy for Dementia.

The purpose of this study is to determine if a home based occupational therapy is effective in the treatment of dementia.


Eligibility Criteria:
Inclusion Criteria:

1. Dementia (according to DSM-IV TR)
2. A score 26 to 12 on the MMSE
3. Must be 55 or older
4. Patient is living at home or therapeutical flat sharing
5. Primary care giver at least 2 days / week available at home
6. Written informed consent from patient and care giver
7. German as dominant language

Exclusion Criteria:

1. Other dementia (p.e. frontotemporal dementia, dementia with Lewy Bodies, Creutzfeldt-Jakob disease, Parkinson's disease or atypical Parkinson's syndromes
2. Dementia with relevant displaying behavioural problems (neuropsychiatric Inventory; NPI, Subscore ≥ 8)
3. Depressive episodes (Geriatric Depression Scale, GDS (short version) ≥ 6)
4. Mental disability
5. Home Based Occupational Therapy for Dementia within the last 6 months
6. Impairment of visual and/or acoustic cognition which does not allow Occupational Therapy
7. Apoplexy with movement disorders which does not allow Occupational Therapy
8. Severe physical/systemic illnesses (cardio-pulmonal, Hematological or metabolic) which do not allow participating
9. Recent history of addictive disorder
10. Intermittent intake of depressant medication, that likely causes an impairment of cognitive performance during the trial
11. Participation in another clinical trial
Regular Swimming, Vascular Function, and Arthritis

Hypothesis #1: The investigators hypothesize that both swimming training and cycling training will demonstrate significant improvements in endothelium-mediated vasodilation and central artery compliance in this population and that there will be no difference in the magnitude of increases between the water-based and land-based exercise interventions.

Hypothesis #2: The investigators hypothesize that the improvements in endothelium-dependent vasodilation and arterial compliance in response to exercise training interventions will be related to the corresponding reductions in inflammatory biomarkers.

Hypothesis #3: The investigators hypothesize that both swimming exercise and cycling exercise will improve functional capacities and disease progression in middle-aged and older adults with osteoarthritis.

Middle-aged and older men and women (40-90 years old) of all races and ethnic backgrounds will serve as subjects after obtaining their written, informed consent. All the subjects will have a radiological diagnosis of osteoarthritis according to American College of Rheumatology criteria.

Eligibility Criteria:
Inclusion Criteria:

* All the subjects will have a radiological diagnosis of osteoarthritis according to American College of Rheumatology criteria
* Subjects will be sedentary (i.e., no regular physical activity for at least the prior 1 year)

Exclusion Criteria:

* Subjects with significant intima thickening,
* plaque formation, and/or characteristics of atherosclerosis.
* unstable cardiac or pulmonary diseases.
* joint replacement surgery in the previous year.
* intraarticular injection nor systemic steroids within previous 3 months.
* severe disabling co-morbidity that disallows receiving exercise therapy.
* excess alcohol use (\>21 drinks/week).
* unwillingness to perform exercise.
* fear of water.
* mental incapability
The Effects of Traditional Chinese Medicine Mouthwash Solutions on the Oral Health of Leprosy Patients

The purpose of this study is to treat with traditional Chinese medicine mouthwash, and through the research of dental plaque detection and xerostomia questionnaire and traditional Chinese medicine treatment mechanism.

The study will recruit 58 patients who are hospitalized at Lo-Sheng Sanatorium, Ministry of Health and Welfare. Investigators will use xerostomia questionnaire and PLI examination to collect the subject's data. Separate subjects in to two group randomly. The control group will use the traditional Chinese medicine mouthwash, and the other group will use the dilute 50 times of traditional Chinese medicine mouthwash.

Every 7 days will record the PLI value and conduct a xerostomia questionnaire, until 21 days.

Eligibility Criteria:
Inclusion Criteria:

* Residents of Lo-Sheng sanatorium of the Ministry of Health and Welfare, Taiwan
* Compliant with the presence of more than four teeth in each of the upper and lower four regions
* Those who have not used antibiotics and mouthwash two months before the test

Exclusion Criteria:

* Moderate to severe dementia
* CDR (Clinical Dementia Assessment Scale) is greater than or equal to 2 points or more
* Those with a score of less than 17 on the MMSE Simple Mind Scale
* Nasogastric Tube Inserters
* Those who are allergic to mouthwash
* Those who are on course of antibiotics and steroids
* Those who have had dental cleansing within one month
Study of PRN and Every 2months Intravitreal Aflibercept for Age Related Macular Degeneration

Evaluate a treatment result of every two months versus as needed (PRN) after 3 initial monthly intravitreal aflibercept for the Japanese age related macular degeneration.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of age-related macular degeneration

Exclusion Criteria:

* Any treatment before intravitreal Aflibercept for age-related macular degeneration.
* Visual acuity above 0.1 in decimal visual acuity
Effectiveness of Mechanical Decompression for Low Back Pain Relief

Objective To demonstrate the effectiveness of a conservative treatment approach for chronic low back pain that addresses the underlying problem of intervertebral disc lesions and degenerative disc disease, namely vertebral pressure on vital structures of the lumbar region.

Low back pain (LBP) is a common medical problem and a challenging condition to treat. This study will investigate the effectiveness of a conservative treatment approach for chronic LBP. To this point few treatment approaches specifically address the resolution of underlying pathologies leading to a high probability of recurrence of LBP. Further, current treatment options for lumbar disc pathology have been of limited demonstrated effectiveness. The purpose of this study is to determine whether a non-surgical therapeutic approach designed to effect intervertebral widening and allow for reduction of disc protrusion will reduce patients' pain and improve their activity levels.

The study will assess whether a computer-assisted traction treatment \[decompression\] protocol results in improvement in patient pain levels and daily activity levels. Further, to determine if such treatment results in intervertebral widening and reduction of any disc protrusions as demonstrated by direct imaging of the lumbar spine. A double-blind (treatment vs. sham treatment) design will be employed

Specific Aims To study the effectiveness of decompression therapy for LBP patients with lumbar disc herniation and degenerative disc problems.

To demonstrate that decompression therapy for LBP patients results in a demonstrated reduction in levels of reported pain.

To demonstrate that decompression therapy for LBP patients results in a demonstrated greater return to daily activities.

To demonstrate that decompression therapy for LBP patients results in increased intervertebral space and reduced disk protrusion (if present) as measured by MRI.

Eligibility Criteria:
Inclusion Criteria:

* Non-specific LBP of at least 6 weeks duration with no evidence of underlying disease or anatomic abnormalities,
* Applicants may have pain radiating to their legs.

Exclusion Criteria:

* Any episode of Acute LBP within the last 6 weeks or less
* Recent Fractures, less than 8 weeks of any bone
* Tumors of any type including soft tissue tumors, myeloma, malignant or documented tumors of any type
* Gross osteoporosis,
* Spondylolisthesis grade 2 and above,
* Hardware fixation, spine fixation or other boney fusion
* Obesity as defined by a BMI greater than 35, body weight over 287 pounds,
* Contra-indication for MRJ assessment,
* Pregnancy,
* neurologic deficits,
* bowel or bladder incontinence,
* progressive lower extremity weakness,
* need for narcotic pain medications for other conditions.
IFM 2005-01: Velcade/Dexamethasone Versus Vincristine/Adriamycin (Doxorubicin)/Dexamethasone (VAD) for the Treatment of Patients With Multiple Myeloma

This is an open-label, multi-centre, randomised Phase III study, looking at a series of 480 patients up to the age of 65 with newly diagnosed multiple myeloma (MM) not previously treated. They will receive VAD or Velcade®/dexamethasone combination as induction treatment plus/minus (±) dexamethasone/cyclophosphamide/etoposide/cisplatin (DCEP) followed by autograft as first-line therapy, as the investigators try to compare the complete remission (CR) rate (with negative or positive immunofixation) at the end of their induction treatment.

After their written informed consent has been obtained and their eligibility verified, patients are randomised between 4 treatment arms: A1 VAD (4 cycles); A2 VAD (4 cycles) followed by DCEP (2 cycles); B1 Velcade® + dexamethasone (4 cycles); B2 Velcade® + dexamethasone (4 cycles) followed by DCEP (2 cycles) A1, A2, B1, B2 + autograft. Randomisation will be stratified on the basis of the initial b2 microglobulin level (\> or \< 3 mg/l) and the presence of chromosome 13 abnormalities identified by FISH analysis. VAD: Vincristine/Adriamycin/Dexamethasone; DCEP: Dexamethasone/Cyclophosphamide/ Etoposide/Cisplatin.

Eligibility Criteria:
Inclusion Criteria:

* Recently diagnosed MM according to the criteria of the South West Oncology Group (SWOG)
* Not previously treated, apart from local radiotherapy, in the case of a threatening or incapacitating lesion, and/or a 4-day block of dexamethasone (40 mg/mL) in an emergency
* Stage II or III disease according to the Durie and Salmon classification or Stage I disease with symptomatic bone lesion
* \< 65 years of age
* Ability to give signed informed consent
* Secretion of a measurable monoclonal spike (\> 10 g/l in the serum or 0.2 g/24h in the urine)
* Negative pregnancy test at inclusion (if necessary)
* Absence of active infection. In the case of infection, appropriate antibiotic therapy must be administered and patients must have been apyretic for 48 hours before the start of treatment with VAD or Velcade®/dexamethasone

Exclusion Criteria:

* ECOG performance status \> 2
* History of cancer (other than basal cell carcinoma or carcinoma of the cervix in situ)
* Life expectancy \< 2 months
* Confirmed amyloidosis
* Positive HIV serology
* Serious psychiatric item in the history
* Renal failure requiring dialysis
* Uncontrolled diabetes, contra-indicating the use of corticosteroids
* Peripheral neuropathy National Cancer Institute (NCI) grade \> 2 (Annex 5)
* Clinical signs of heart failure or coronary heart disease
* Bilirubin \> 3 x normal
* Transaminases or gamma-glutamyl transpeptidase (GT) \> 4 x normal
* Platelets \< 50 x 10\^9/l during the 15 days prior to inclusion
* Neutrophils \< 0.75 x 10\^9/l during the 15 days prior to inclusion
* Use of an investigational medicinal product during the 30 days prior to inclusion
* Known hypersensitivity to bortezomib, boron or mannitol
Abiraterone Acetate Combined With Dutasteride for Metastatic Castrate Resistant Prostate Cancer

The purpose of this research study is to determine if the addition of dutasteride to a regimen with abiraterone acetate and prednisone will improve on therapy in patients with castrate-resistant prostate cancer and metastatic disease. This study will also help determine the side effects of the study treatment and how often they occur.

Patients will receive abiraterone acetate and prednisone orally, once daily for 2 months (2 cycles) on an outpatient basis. At the start of cycle 3, dutasteride will be taken once daily. Patients will return to the clinic on Day 14 of the first 3 cycles for routine blood tests.

Patients will come to the clinic every 12 weeks for a CT scan and/or x-ray of the chest, CT scan or MRI of the abdomen and pelvis, bone scan, and blood test for testosterone and other specialized blood test.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of adenocarcinoma of the prostate
* Castrate resistant disease
* Metastatic disease
* Normal organ and marrow function
* Subjects with partners of childbearing potential must be willing to use adequate methods of birth control

Exclusion Criteria:

* Uncontrolled intercurrent illness
* Uncontrolled hypertension
* Active or symptomatic viral hepatitis or chronic liver disease
* History of pituitary or adrenal dysfunction
* Clinically significant heart disease
* History of a different malignancy unless disease-free for at least 5 years
* Known brain metastasis
* History of gastrointestinal disorders
* Prior therapy with abiraterone acetate
* HIV-positive individuals on antiretroviral therapy
* Requirement for steroid use greater than the equivalent of 5 mg of prednisone daily
* Atrial fibrillation or other cardiac arrhythmia requiring therapy
* Thromboembolism in the last 6 months
Protection of Rectum From High Radiation Doses

The purpose of this study is to evaluate the usefulness of diluted DuraSeal product as a spacer between prostate and rectum in prostate cancer low dose brachytherapy.

Radiation therapy for prostate cancer leads to inappropriate radiation dose to the rectum wall leading rectum adverse effects in long term for some patients. A resorbable spaces between prostate and rectum could decrease the incidence of these side effect. In this trial, men with prostate cancer with intention to curative treatment by low dose brachytherapy will be recruited. Diluted DuraSeal will be applied between rectum and prostate at the end of the brachytherapy seed implantation procedure. After the implantation of the brachytherapy seeds, a needle is placed between rectum and prostate through perineal skin under transrectal ultrasound guidance. The proper position of the needle is confirmed by the injection of 10-15 ml sterile saline solution. After that, DuraSeal components are diluted in 1:1 with sterile saline and 6-10 ml of this diluted product will be injected using DuraSeal applicator. The resolution of the spacer will be followed by repeated plain computer tomography (CT) of pelvis performed a day before operation, a day after the operation, 4 weeks after the operation and 8 weeks after the operation. In addition, magnetic resonance imaging of pelvis performed 8 to 16 weeks after the operation. The space created between prostate and rectum will be documented by plain CT and magnetic resonance imaging. Rectum radiation dose will be calculated based on these scans. Time to DuraSeal resolution will be evaluated from the scans. Possible side effects will be collected by subject interviews during follow-up visits at 4, 8 and 12 weeks after the operation.

Eligibility Criteria:
Inclusion Criteria:

* prostate cancer patients with planned low dose brachytherapy for the treatment of prostate cancer

Exclusion Criteria:

* not willing to participate this study
The Safety and Effectiveness of U-90152 in HIV-1 Infected Patients Who Take Zidovudine

To evaluate the pharmacokinetics, safety, and tolerance of delavirdine mesylate ( U-90152 ) after multiple doses given orally to asymptomatic HIV-1 positive patients who are maintained on a stable dose of zidovudine ( AZT ). To investigate the optimum dose regimen of U-90152 that gives average trough concentrations \> 1 micromolar in combination with standard AZT therapy, and to examine drug interactions between the two drugs. To establish the MTD of U-90152 in HIV-1 positive patients on stable AZT therapy. To investigate comparative pharmacokinetics between HIV-1 positive men and women.


Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed:

* Inhaled pentamidine following completion of the inpatient pharmacokinetic portion of the study.

Patients must have:

* HIV-1 infection.
* CD4 count 200 - 500 cells/mm3.
* Maintenance on AZT for at least 6 weeks.
* No active opportunistic infections.
* Ability to swallow numerous tablets without difficulty.
* Ability to have blood samples drawn.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Acute medical problems, including opportunistic infections (such as active cryptococcosis, pneumocystis carinii, herpes zoster, histoplasmosis, CMV) and nonopportunistic diseases (liver and renal disease, orthostatic hypotension, hypertension, progressive multifocal leukoencephalopathy, lymphoma, Kaposi's sarcoma, or other malignancy).
* Clinically significant hypersensitivity to piperazine type drugs (Antepar, Stelazine, and U-87201E).
* Negative EMIT drug screen or equivalent for drugs of abuse.

Concurrent Medication:

Excluded:

* Antiretroviral agents other than AZT.
* Primary or secondary prophylactic medications for opportunistic infections (inhaled pentamidine is permitted following completion of the inpatient pharmacokinetic portion of the study).

Patients with the following prior conditions are excluded:

* History of clinically significant nervous system or muscle disease, seizure disorder, AIDS dementia, or psychotic disorder that might impair study compliance.
* History of clinically significant cardiovascular, renal, hepatic, cardiac, pulmonary, endocrine, hematologic, vascular, or collagen disease.

Prior Medication:

Excluded:

* Prior U-87201E or other non-nucleoside reverse transcriptase inhibitors (nevirapine, TIBO, L-drugs, and HEPT).
* Antiretroviral agents (other than AZT) or immunomodulating agents within 15 days prior to study entry.
* Primary prophylactic drugs within 15 days prior to study entry.
* Any known enzyme-inducing drug or any enzyme-inhibiting agents, such as ketoconazole, fluconazole, rifampin, isoniazid, and cimetidine, within 15 days prior to study entry.
* Any investigational medication within 15 days prior to study entry. Unwilling to comply with safer sex practices. Active substance abuse. Alcohol consumption during the inpatient pharmacokinetic portion of the study.
Photodynamic Therapy Using HPPH in Treating Patients With Recurrent Dysplasia, Carcinoma in Situ, or Stage I Oral Cavity Cancer

RATIONALE: Photodynamic therapy uses a drug, such as HPPH, that is absorbed by tumor cells. The drug becomes active when it is exposed to light. When the drug is active, tumor cells are killed.

PURPOSE: This phase I trial is studying the side effects and best dose of photodynamic therapy using HPPH in treating patients with recurrent dysplasia, carcinoma in situ, or stage I oral cavity cancer.

OBJECTIVES:

Primary

* To determine the maximum tolerated dose in the oral cavity of photodynamic therapy (PDT) using HPPH and 665 nm light in patients with recurrent dysplasia, carcinoma in situ, or stage I squamous cell carcinoma of the oral cavity.

Secondary

* To determine response of dysplasia, carcinoma in situ, and selected patients with T1 squamous cell carcinoma of the oral cavity using PDT with HPPH and 665 nm light.

OUTLINE: This is a dose-escalation study of laser light dose therapy.

Patients receive HPPH IV over 1 hour on day 1. Approximately 24 hours after receiving HPPH, patients undergo laser light treatment to the tumor bed on day 2. Patients with multicentric or large area confluent disease receive a second course of treatment at least 8 weeks later for lesions untreated at the first treatment session.

After completion of study treatment, patients are followed at 1 week, 1 month, 3 months, and periodically thereafter.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Biopsy-confirmed diagnosis of 1 of the following:

  * Mild to severe dysplasia
  * Carcinoma in situ (CIS) of the oral cavity

    * Carcinoma must be less than 3mm thick
  * Stage I (T1) squamous cell carcinoma of the oral cavity
* Recurrent or primary disease
* No T2 or greater squamous cell carcinoma, exophytic CIS, or dysplasia lesions

PATIENT CHARACTERISTICS:

* ECOG performance status 0-2
* Total bilirubin ≤ 2.0 mg/dL
* Creatinine ≤ 2.0 mg/dL
* Alkaline phosphatase ≤ 3 times the upper limit of normal (ULN)
* SGOT ≤ 3 times ULN
* Not pregnant
* Fertile patients must use effective contraception
* No porphyria or hypersensitivity to porphyrin or porphyrin-like compounds

PRIOR CONCURRENT THERAPY:

* Prior therapy of any type allowed
* More than 4 weeks since prior and no concurrent chemotherapy or radiotherapy
User Testing and Feedback for a Mobile Health Program for Postpartum Women: A Pilot Study

Refine content and delivery of the mHealth delivered lifestyle intervention program through iterative testing with small groups of users who provide feedback through on-line asynchronous focus groups.

Participants are asked to:

* Use mobile app for 4 weeks
* Receive support from the lifestyle coach
* Provide weekly and ongoing feedback via an online asynchronous user group platform on usability, navigability, acceptability, and satisfaction.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-45
* Body Mass Index (BMI): 25 - 45 kg/m2
* Positive history of one or more of the following complications in most recent singleton pregnancy:

  1. Gestational diabetes mellitus
  2. Preeclampsia (high blood pressure and proteinuria diagnosed after 20 weeks gestation)
  3. Gestational hypertension (new hypertension diagnosed after 20 weeks without proteinuria)
  4. Pre-term delivery (32-37 weeks)
  5. Small for gestational age (\<10th percentile for gestational age)
* Able to communicate in English
* Access to and be willing to use a wi-fi enabled iPhone or iPod
* Access to a computer with internet access
* Capable of providing informed consent
* Between 4 weeks and 24 weeks after delivery

Exclusion Criteria:

* Personal history of Type 1 or 2 diabetes
* Personal history of breast cancer or any other type of cancer other than a basal cell skin cancer;
* Personal history of major chronic illness including cardiovascular disease (coronary artery disease, congestive heart failure, valvular heart disease, stroke, transient ischemic attack, or intermittent claudication), kidney disease, liver disease, venous or arterial thromboembolic disease, adrenal insufficiency, depression requiring hospitalization within the past 6 months, or non-pregnancy related illness requiring overnight hospitalization in the past 6 months;
* Underlying disease/treatment that might interfere with participation in/completion of the study (e.g. significant gastrointestinal conditions, major psychiatric disorders, and others at the discretion of the study clinician)