cyrilzakka/clinical-trials huggingface dataset:
Tele-spirometry in Primary Care-Randomized Clinical Trial Cluster:Telemedicine in Chronic Obstructive Pulmonary Disease

The purpose of this study is to determine the effectiveness of telemedicine multifaceted intervention in symptoms patients with chronic obstructive pulmonary disease.

This study is a randomized clinical trial for patients with chronic obstructive pulmonary disease from a primary care. The purpose is to determine the effectiveness of telemedicine (teleconsultation and telemonitoring) in control of chronic obstructive pulmonary disease symptoms.

Eligibility Criteria:
Inclusion Criteria:

* spirometry from TelessaudeRS-Universidade Federal do Rio Grande do Sul (from randomization cluster), Modified Medical Research Council Dyspnea \> 0

Exclusion Criteria:

* normal or restrictive spirometry, low quality spirometries (inadequate)
Conservative Treatment and Ultrasound Guided Injection for Treatment Meralgia Paresthetica

Meralgia paresthetica (MP) is an entrapment mononeuropathy of the lateral femoral cutaneous nerve (LFCN), where conservative treatment options are not always sufficient.

The aim of this study was to evaluate the efficacy of ultrasound (US) guided lateral femoral cutaneous nerve injection in the management of meralgia paresthetica by comparing with transcutaneous electrical nerve stimulation (TENS) therapy and sham transcutaneous electrical nerve stimulation therapy.

In this prospective, randomized, sham-controlled study, fifty four patients (23 female and 31 male, the mean age 53.61±11.99 years) with lateral femoral cutaneous nerve compression with clinical and electrophysiological findings were enrolled. Patients were randomly assigned to three groups: 1) Ultrasound-guided injection group, 2) TENS group, 3) Sham TENS group. The blockage of the lateral femoral cutaneous nerve was performed for therapeutic meralgia paresthetica management in group 1. Ten sessions of conventional TENS were administered to each patient 5 days a week for 2 weeks, for 20 minutes per daily session in Group 2, and sham TENS was applied to group 3 with the same protocol.

Visual Analog Scale (VAS), painDETECT questionnaire (PD-Q), Semmes Weinstein monofilament test (SWMt), Pittsburgh Sleep Quality Index (PSQI) and health-related quality of life (SF 36), at onset (T1), 15 days after treatment (T2) and 1 month after treatment (T3) were used for evaluation.

Eligibility Criteria:
Inclusion criteria

* Patients diagnosed with LFCN entrapment confirmed by clinical and electrophysiological findings

Exclusion criteria

* Secondary entrapment neuropathy
* Malignancy
* Pregnancy
* Infection in the inguinal region or dermatitis
* Lumbar radiculopathy
* Cardiac pacemakers
* Polyneuropathy
Nature and Animal-assisted Activities

Neuropsychiatric impairments in young adults are common and can involve social withdrawal, and difficulties in receiving support from healthcare and municipal social care services. Collaboration is needed, but knowledge gaps exist concerning effective interventions. Participation in meaningful activities, as a complement to other treatment strategies can be a step towards studies/work. The aim of the trial is to explore the feasibility of a structured nature and animal-based activity on a farm for young adults with neuropsychiatric impairments.

The intervention involves participation in nature and animal-assisted group activities, twice a week for 12 weeks. Data consists of interviews with participants prior to and after the intervention, as well as one year later. The one-year follow-up focus is on life situation, changes in everyday life and experiences of the intervention. In addition, interview-based experiences of the ordinary staff and supervisors on the farm are included. Analysis will be carried out with qualitative content analysis, as well as health-economic calculations.


Eligibility Criteria:
Inclusion Criteria:

* 18-30 years
* Autism Spectrum Disorder
* No occupation/employment/education over the last year
* Social insurance benefits
* Interest in being with animals

Exclusion Criteria:

* Ongoing active drug abuse
* Severe psychiatric comorbidity
Safety and Efficacy Study of Doxycycline/UrsoDeoxyCholicAcid on Disease Progression in ATTR Amyloidosis

The primary objective for this study is to evaluate the efficacy of doxycycline + ursodeoxycholic acid (UDCA) on disease progression in Transthyretin Amyloidosis (ATTR) subjects with cardiomyopathy with or without neuropathy.


Eligibility Criteria:
Inclusion Criteria:

* Cardiomyopathy with septal thickness \> 15 mm and/or S-NT-ProBNP \> 300 ng/
* Age \>50 years
* Male and females after menopause. Menopause is defined as 6 to 12 months of amenorrhea in a woman over 45 years of age.
* Written informed consent to be obtained prior to any study procedure
* Histochemical diagnosis of amyloidosis as based on detection by polarizing microscopy of green birefringent material in Congo red-stained tissue specimens, and typing of amyloid deposits as TTR and identification of amyloid fibril type.
* Molecular definition of the TTR mutation or immunohistochemical staining of amyloid fibrils with anti TTR antibody
* New York Heart Association (NYHA) class \<III
* Systolic blood pressure \>100 mmHg (standing)
* Must have symptomatic organ involvement with amyloid to justify therapy

Exclusion Criteria:

* Liver transplantation in the previous 6 months or liver transplantation anticipated in less than 6 months;
* ALT and/or AST \> 2 x upper normal limit (UNL);
* Creatinine clearance \< 30 ml/min (Cockcroft -Gault Formula)
* Any other lab values, illness or condition that in the opinion of the investigator might place the subject at unacceptable risk for participation in the study;
* History of hypersensitivity to any of the ingredients of the study therapies;
* Use of any investigational drug, device (or biologic) within 4 weeks prior to study entry or during the study.
Icotinib With Concurrent Radiotherapy vs. Chemoradiotherapy in Non-small Cell Lung Cancer

The current standard of care for unresectable locally advanced non-small-cell lung cancer (NSCLC) is a combination of chemotherapy and thoracic radiotherapy (TRT). The standard regimens consist of platinum-based doublet chemotherapy.Icotinib(BPI-2009, Conmana) is the first self-developed small molecular drug in China for targeted therapy of lung cancer.Icotinib is a novel oral quinazoline compound that has proven survival benefit in Chinese patients with lung cancer,especially in EGFR mutation lung cancer. This randomised, multi-center, controlled trial is designed to assess the efficacy and safety of icotinib with concurrent radiotherapy versus pemetrexed + carboplatin with concurrent radiotherapy in inoperable stage III non-small cell lung cancer with EGFR mutation, the primary endpoint is progression-free survival.


Eligibility Criteria:
Inclusion Criteria:

1. Unresectable stage IIIA / IIIB non-small cell lung cancer with EGFR 19/21 mutation.
2. No previous systemic anticancer therapy.
3. life expectancy more than three months.
4. ECOG Performance Status of 0 to 1.
5. Measurable lesion according to RECIST with at least one measurable lesion not previously irradiated, unless disease progression has been documented at that site.
6. Patients will be required to provide informed consent before enrollment.

Exclusion Criteria:

1. Intrapulmonary metastasis, atelectasis of an entire hemithorax,pleural dissemination, or contralateral hilar lymph node metastasis.
2. Prior chemotherapy for NSCLC, chest irradiation therapy, or therapy directed at the epidermal growth factor receptor pathway.
3. Severe heart disease, uncontrolled diabetes mellitus, or active infection.
4. Active concomitant malignancy, and pregnancy or breast-feeding.
Wearable Robotic Functional Assistance for Stroke Rehabilitation

This study aims to evaluate the effectiveness of using the myomo e100 wearable robotic rehabilitation system for increasing functional independence and long term rehabilitation of chronic stroke victims with a hemiparetic upper extremity.

This is a case controlled study for evaluation of the effectiveness of using the myomo e100 wearable robotic rehabilitation for upper arm therapy following stroke.

The intervention for the study will be for the control group- 6-8 weeks of therapeutic exercise and functional training for a total of 18 hours of intervention, or the case group- 6-8 weeks of therapeutic exercise and functional training with the use of the AJB for a total of 18 hours of intervention. Each session will be one hour in length. The length of the study and length of each session is per standard rehabilitation protocol that has been well documented in previous studies as well as the pilot study regarding the AJB. A pre and post test with a 3 month follow up of all measures will be included in the study.

Study procedures will focus on performing functional tasks using the e100.

Eligibility Criteria:
Inclusion Criteria:

* Medically Stable
* Cognitive Awareness
* Weakness in upper arm
* Over 1 year post CVA
* not engaged in any other upper arm therapies

Exclusion Criteria:

* Rashes, open wounds or skin sensitivity on arm
* Very high elbow tone (arm rigid in flexion or extension)
Efficacy Study of the LARA Wheelchair System for Subacute Stroke Patients

This study will test the effectiveness of a new lever drive wheelchair, LARA - Lever Actuated Resonance Assistance. LARA facilitates patients in performing a high amount of practice using their moderate to severely impaired upper extremity after stroke.

Investigators will recruit 44 subjects with subacute strokes to participate in the study through the acute rehabilitation unit of the UC Irvine Douglas Hospital. Study participants will be randomized into 2 groups: LARA therapy group or standard therapy group. The LARA therapy group will use LARA to propel themselves to therapy appointments in the unit and to play video games with the affected upper extremity for 30 mins / day. The standard therapy group will use a standard wheelchair to propel themselves using their unaffected upper and lower extremities. They will be asked to perform a matched duration of standard arm exercises for 30 mins/ day. This program of standard arm exercises was developed by an OT at the Rehabilitation Institute of Chicago which consists of graded-difficulty table-supported exercises.

This study will have 3 assessment visits: baseline, 3 weeks after therapy or upon discharge from the acute rehabilitation unit if sooner, and a 3-month follow up.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years at the time of enrollment
2. Stroke onset 1-4 weeks prior to study enrollment
3. Arm motor FM score of \< 30 (out of 66) at Baseline Visit
4. Absence of moderate to severe shoulder pain ( Score \<3 on the 10 point visual analog pain scale)
5. Any deficit in vision, alertness, language, attention, or other cognitive functions that interfere with playing the LARA games

Exclusion Criteria:

1. Age \>80 years at the time of enrollment
2. Severe tone in the affected upper extremities (Score ≥ 4 on the Modified Ashworth Spasticity Scale)
3. Severe language problem that would prevent participants from properly understanding instructions
4. Severe reduced level of consciousness
5. Severe aphasia (score of 3 on the NIH stroke scale (question 9))
6. Severe loss of sensation in stroke-affected upper extremities (Score \< 1 on the Nottingham sensory assessment)
7. Currently pregnant
8. Difficulty in understanding or complying with the instructions given by the experimenter
9. Inability to perform the experimental task that will be studied
Tailoring Screening, Brief Intervention, and Referral to Treatment for Medical ICU Survivors

Unhealthy alcohol use is present in up to 38% of the 4 million patients admitted to an American intensive care unit (ICU) each year in the US. Despite the high prevalence of unhealthy alcohol use in ICU survivors, routine interventions targeted at reducing alcohol consumption, alcohol-related consequences, and illness related to alcohol are not currently part of the multidisciplinary approach to critical care. Although screening, brief intervention, and referral to treatment (SBIRT) has been described in several healthcare settings, it fails to address common characteristics of medical ICU survivors including high rates of alcohol use disorders, cognitive dysfunction, psychiatric comorbidities, and intimate involvement of friends and family. This study uses a qualitative approach to further understand the needs of medical ICU survivors with unhealthy alcohol use. The investigators hypothesize that there are common, modifiable barriers to improving alcohol-related outcomes


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* admitted to the medical ICU
* resolution of critical illness
* resolution of delirium/agitation
* AUDIT score 8 or greater for men, 5 or greater for women

Exclusion Criteria:

* unable to provide informed consent
* prisoner
* Unable to speak or write in English
* Pregnant
Followup of Glenoid Fix Utilizing Auto Bone Graft in Shoulder Replacement

This is a case study to evaluate the adequacy of fixation and functional outcome of the glenoid anchor peg following autologous bone grafting around the prosthesis at the time of implant.

To investigate if the use of autologous bone graft around the anchor-peg glenoid prosthesis correlates with bony apposition on computed tomography scans, decreased radiolucent lines and component loosening, and functional outcomes. We hypothesize that by utilizing autologous bone graft from the resected humeral head, placed around the anchor peg glenoid prosthesis at implantation, there is a low incidence of glenoid loosening. We suggest that the absence of radiolucent lines correlated with excellent shoulder function.

Eligibility Criteria:
Inclusion Criteria:

* Patients who received a total shoulder replacement with an anchor peg glenoid and autologous bone grafting from the investigator of this study will be recruited for this study.

Exclusion Criteria:

* Patients will be excluded if they are unable to comprehend the consent information.
* Pregnant women will be excluded from this study.
Evaluation of a Living With Hope Program

The Living with Hope program was developed by the research team, a panel of experts and palliative patients and their families. The program was evaluated with 60 advanced cancer patients 60 years of age and older. Thirty received the program and 30 did not. After one week, those receiving the Living with Hope Program had higher hope and quality of life scores compared to those who did not. This suggests that the program is effective in increasing hope and quality of life for older palliative care patients with cancer.

The overall purpose of this study was to evaluate the effectiveness of a psychosocial supportive intervention called "Living with Hope Program" (LWHP) in increasing hope and quality of life for older adult community-living terminally ill cancer patients. Using a mixed method concurrent nested experimental design, 60 terminally ill cancer patients over the age of 60 years were randomly assigned to a treatment and control group. Baseline hope \[Herth Hope Index (HHI)\] and quality of life scores \[McGill Quality of Life Questionnaire, (MQOL)\] were collected at the first visit in the patients' homes by trained research assistants. Those in the treatment group received the LWHP, which consisted of viewing an international award winning video on hope and a choice of one of three hope activities to work on over a one-week period. The control group received standard care. Hope and quality of life data were collected one week later from both groups. Qualitative data using open-ended hope questions were collected from the treatment group.

Subjects receiving the Living with Hope Program had statistically significant higher hope (U=255, p=.005) and quality of life scores at visit two (U=294.5, p=.027) than those in the control group. Qualitative data confirmed this finding with the majority (61.5%) of subjects in the treatment group reporting the LWHP increased their hope. This preliminary evaluation of the effectiveness of the LWHP suggests that it may increase hope and quality of life for older terminally ill cancer patients at home.

Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria for the study is; a) male or female 60 years of age and over, b) diagnosed with cancer, c) receiving palliative home care services d) English speaking, e) able to give informed consent and participate in the study as determined by the Palliative Care Coordinator or SWADD team's assessment.

Exclusion Criteria:

Exclusion criteria includes patients who are non-autonomous adults, cognitively impaired as determined by the SWADD team and or unable in the opinion of the SWADD team to participate-
Rapid Sequence Induction EU: Electronic Survey (RSIEU)

Rapid sequence induction (RSI) is a common part of routine anesthesiology practice. However several steps of RSI are not based on evidence based data (EBM) and are considered controversial. In an electronic evaluation form that will be send to European Society of Anaesthesiology (ESA) members. The electronic survey will contain 22 question (11 for adult RSI and 11 for paediatric RSI). In the questionnaire the participants will have to describe their routine clinical practice in performing rapid sequence induction.

Rapid sequence induction (RSI) is a common part of routine anesthesiology practice. However several steps of RSI are not based on evidence based data (EBM) and are considered controversial. In an electronic evaluation form that will be send to European Society of Anaesthesiology (ESA) members. The electronic survey will contain 22 question (11 for adult RSI and 11 for paediatric RSI). In the questionnaire the participants will have to describe their routine clinical practice in performing rapid sequence induction.

The 11 will be consulted with the research committee of ESA.

Eligibility Criteria:
Inclusion Criteria:

- Members of European Society of Anaesthesiology

Exclusion Criteria:

- not members of ESA
Clinical Implications of HIV Low-level Viremia at Times of Highly Active Antiretroviral Treatment Regimens

Retrospective analysis of HIV-1 positive patients treated with antiretroviral therapy in Essen (Germany) from 2004 on. Stored samples from selected patients (n=50) obtained for routine diagnostics will be used to analyze the gag gene, the V3-region of the env gene and immune cells.

The underlying study is a retrospective analysis of HIV-1 positive patients treated with antiretroviral therapy from Essen since 2004. Stored samples obtained for routine diagnostics will be used to analyze the gag gene, the V3-region and immune cells from selected patients. By comparing different groups of patients this study aims to identify clinical implications of low-level viremia (LLV) and persistent viremia (PV) at times of highly active antiretroviral treatment regimens (cART). The objectives of this study is to (1) determine how often LLV and PV occured during cART in Essen in the last 10 years and whether specific patterns can be correlated, (2) whether the evolution of PI drug resistance can be detected earlier in the gag than in the protease gene, (3) what kind of cellular tropism do HIV-1 isolates (RNA and proviral DNA) have at times of LLV, and (4) what kind of immune cells circulate in the blood during LLV and PV and what kind of functional properties do they have. The groups include patients starting cART as well as patients with cART. Furthermore, clinical data of patients are routinely documented and will be combined with results specifically obtained in this study in an anonymized data set. Since this is a retrospective study, there are no specific endpoints.

Eligibility Criteria:
Inclusion Criteria:

* Chronic HIV-1 infection
* Age \> 18 years
* Patients treated in Essen in the last 10 years

Exclusion Criteria:

- no antiretroviral therapy / treatment
The Study to Evaluate Patient Outcome Using Distal Protection Combined With the BX Velocity.

The primary objective is to evaluate the use of the AngioGuard™ device combined with the Bx Velocity™ on patient outcome at one month.

This is a prospective, non-randomized, multi-center trial. Patients will be treated with the AngioGuard™ device and Bx Velocity™ stent and will be followed for six-months post-procedure.

Eligibility Criteria:
Inclusion Criteria:

* Unstable angina pectoris (Braunwald classification B \& C, I-II-III, native vessels)
* or lesion located in the SVG;
* Single de novo or restenotic lesion requiring treatment in a major native coronary artery or saphenous vein graft;
* The vessel diameter to place the AngioGuard™ device in must be \> 3 and \< 5.5 mm (6.5 when the 7mm AngioGuard™ is available);
* Target lesion stenosis is \>50% and \<100% (TIMI 1).

Exclusion Criteria:

* A Q-wave or non-Q-wave myocardial infarction within the preceding 72 hours unless the CK and CK-MB enzymes are back to normal;
* More than one coronary artery is 100% occluded;
* Patient has unprotected left main coronary disease with \> 50% stenosis;
* Patient has an ostial target lesion;
* Significant (\>50%) untreated stenosis proximal or distal to the target lesion that will be treated during the procedure, since this may require revascularization or impede runoff;
* Ejection fraction \<30%;
* Totally occluded vessel (TIMI 0 Level).
Comprehensive Ambulatory Antibiotics for the Treatment of Congenital Syphilis

CARES-1 is a randomised, open-label, phase II pharmacokinetic (PK) and safety study of ambulatory antibiotics for the treatment of neonates with "all-risk" asymptomatic congenital syphilis.


Eligibility Criteria:
Inclusion Criteria:

1. Infants at risk of congenital syphilis at birth defined as:

   1. an infant born to a mother who tests positive for syphilis in pregnancy using registered and licensed locally-available diagnostic tests for example but not limited to a Treponemal rapid POCT, an RPR or both.

      AND
   2. the mother is untreated in the current pregnancy defined as:

   i. she tested positive at antenatal care and received no treatment OR ii. she was never tested during antenatal care OR iii. she tested negative at antenatal care and positive on re-testing at delivery

   OR c. the mother is inadequately treated in the current pregnancy defined as:

   i. Having received a non-penicillin based treatment regimen; and/or ii. Does not have documentation of 3 doses of IM Benzathine Penicillin, given 7-10 days apart, with the last dose given \> 30 days prior to delivery OR b. The mother was adequately treated in the current pregnancy BUT considers herself at risk of re-infection following a midwife delivered explanation of risk (partner treatment, multiple partners etc).
2. Infants who are asymptomatic for a diagnosis of congenital syphilis following application of a clinical proforma by the study team (Appendix 1)
3. Infants who are less than \<= 7 days of life AND with a post-menstrual age (PMA) of 34-42 weeks (Appendix 2).
4. Infants who are tolerating enteral feeds, including if they are being administered by an NG tube.

Exclusion Criteria:

- 1. The infant's clinical condition at birth or prior to randomisation requires ongoing (\> 48 hours) treatment with antibiotics with the potential for anti-treponemal activity i.e. B-lactams, Cephalosporins, Carbapenems.

2. They have a birthweight \<2kg 3. They are nil by mouth. 4. They have a life-limiting congenital anomaly