cyrilzakka/clinical-trials huggingface dataset:
Neuromuscular Electrical Stimulation in Chronic Obstructive Pulmonary Disease (COPD)

The purpose of this study is to elucidate whether combination of usual pulmonary rehabilitation and neuromuscular electrical stimulation of quadriceps may improve exercise capacity in patients affected by chronic obstructive pulmonary disease (COPD).

Neuromuscular electrical stimulation (NMES) has been extensively used as technique to improve muscle function in different areas of rehabilitation, however it seems to be more appropriate in critical care situation, while its use in more able patients is of uncertain benefit. In other words, NMES seems to be particularly effective in severely deconditioned and bed ridden patients. We therefore carried out a randomised trial to compare the efficacy of combination of NMES and PR (NM+PR) with combination of sham stimulation and PR (SS+PR) in a large population of moderately impaired COPD patients. Primary outcome was evaluation of effect of NMES on quadriceps strength and on exercise capacity. Secondary outcome was evaluation of effect of NMES on symptoms (dyspnoea) and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of COPD
* Must be able to walk

Exclusion Criteria:

* Previous or current diagnosis of chronic respiratory failure
* A history of diseases other than COPD, in particular neurological disease
* Need for treatment with systemic steroids during the rehabilitation period
LIFU for Treatment for Refractory Opioid Use Disorder

This is a randomized, double-blind, sham-controlled, partial crossover study investigating LIFU targeting the NAc and VC for participants with severe, treatment refractory OUD.

The overall objective of this study is to assess the safety, tolerability, and feasibility of using Low Intensity Focused Ultrasound (LIFU) to treat opioid use disorder (OUD) as well as investigate the potential impact on substance use and risk factors associated with drug use recurrence.

Eligibility Criteria:
Inclusion Criteria:

* Aged 22 - 60 years at time of enrollment.
* Fulfill current DSM-5 (American Psychiatric Association diagnostic and statistical manual of mental disorders, 5th ed, 2013) diagnostic criteria for severe OUD with at least a 2-year history.
* Women of reproductive potential must have negative pregnancy test and agree to use acceptable forms of contraception.

Exclusion Criteria:

* Unable to undergo MR-imaging because of non-MR compatible implants (e.g., pacemakers, medication pumps, aneurysm clips, metallic prostheses (including metal pins and rods, heart valves or cochlear implants), shrapnel fragments, permanent make-up or small metal fragments in the eye that welders and other metal workers may have), or if candidates are uncomfortable in small spaces (have claustrophobia) or cannot lie comfortably on their back for 2-3 hours.
* History of any clinically significant neurological disorder (e.g., brain surgery, tumors, uncontrolled epilepsy, or any others deemed clinically significant by the investigator).
* History of stroke or brain lesion in the targeted brain region (the NAc, ventral striatum, or VC).
* Implanted neurostimulators (e.g., vagus nerve stimulator, spinal cord stimulator, DBS).
* Documentation of clinically significant MRI abnormality indicative of a neurological condition or abnormality that may jeopardize the participant's safety, study conduct, or confound the participant's diagnostic assessments.
* More than 30% of the skull area traversed by the sonication pathway is covered by scars, scalp disorders (e.g., eczema), or atrophy of the scalp.
* Subject with chronic pulmonary disorders e.g. severe emphysema, pulmonary vasculitis, or other causes of reduced pulmonary vascular cross-sectional area.
* Subject with impaired renal function with estimated glomerular filtration rate \<30 mL/min/1.73m2
* Hepatic function laboratory values which are \> 1.5 times the upper limit of normal unless deemed not clinically significant by a study investigator.
* Past or present diagnosis of schizophrenia or psychotic disorder.
* Subject unwilling to attempt abstinence from illicit substance use during the course of the study.
* Unable to speak, read and understand English.
* Subject is considered to be a poor surgical or study candidate, which may include, but is not limited to the following: any medical, social, or psychological problem that could complicate the required procedures and evaluations of the study in the judgment of the investigator.
Safety, Performance of CEREGLIDE 92 Intermediate Catheter in Treatment of Acute Ischemic Stroke

The device is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of acute ischemic stroke.
* NIHSS ≥6
* Baseline mRS ≤ 2
* Completed informed consent.

Exclusion Criteria:

* Known pregnancy.
* Life expectancy less than 90 days prior to stroke onset.
* Known Diagnosis of Dementia
* Treatment with heparin within 48 hours.
* Clinical history, past imaging or clinical judgement suggest that the intracranial occlusion is chronic.
* Computed tomography (CT) or Magnetic Resonance Imaging (MRI) evidence of recent/ fresh hemorrhage on presentation.
* Baseline CT or MRI showing mass effect
* Concurrent sino-venous thrombosis
* Currently participating in an investigational (drug, device, etc.) clinical trial, excluding trials in observational, natural history, and/or epidemiological studies not involving intervention and that will not confound study endpoints. Sponsor approval is required.
Evaluate the Efficacy of AMG 706 to Treat Advanced Gastrointestinal Stromal Tumors

The purpose of the study is to evaluate the safety and efficacy of AMG 706 in patients with gastrointestinal stromal tumor that have not been controlled while taking imatinib mesylate.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of histological confirmed GIST
* Had prior imatinib mesylate therapy
* Has at least 1 measurable leasion by modified RECIST

Exclusion Criteria:

* Central nervous system tumor involvement requiring treatment
* History of myocardial infraction
* Uncontrolled hypertension
Exploratory Study of Breast Cancer With ABY025

The aim is to study if breast cancer metastases accumulate the newly developed HER2 binding molecule 111-In-ABY025 and if that shows whether the metastases express HER2.


Eligibility Criteria:
Inclusion Criteria:

* female age \>20 years
* one or more known metastases localizations

Exclusion Criteria:

* other critical disease than breast cancer
* age ≤ 20 years
Impact of Sympathetic Renal Denervation- a Study in Patients After Renal Transplantation

The study is aiming to document the safety and effectiveness of renal denervation in patients after renal transplantation with hypertension. Catheter-based renal denervation will be performed using CE marked, percutaneous Symplicity catheter.


Eligibility Criteria:
Inclusion Criteria:

* Patient after renal transplantation (\> 6 month) without resection of native kidneys
* systolic blood pressure \>=150 mmHg
* on 3 or more antihypertensive medications
* Individual is 18 years of age
* Individual agrees to have all procedures performed, and is competent and willing to provide written, informed consent to participate in the registry.

Exclusion Criteria:

* secondary causes and a white coat hypertension
* renal artery abnormalities
* eGFR \< 30mL/min (MDRD)
* angina
* severe Aortic valve stenosis
* Individual is pregnant, nursing or planning to be pregnant
* other
Duration of GnRH-analogue Downregulation and Pregnancy Rates

The purpose of this study is to assess whether the probability of pregnancy is dependent on the duration of GnRH agonist downregulation in IVF cycles.

GnRH agonists have been used extensively in assisted reproduction technologies for inhibition of gonadotropin secretion from the pituitary prior to initiation of ovarian stimulation. Administration of GnRH agonists results in the prevention of spontaneous LH surges, which lead to luteinization of the developing follicles, initiation of final oocyte maturation and a decrease in pregnancy rates.

GnRH agonists are usually administered according to two protocols: the short and long protocol.In the long protocol, downregulation with GnRH agonists is initiated either in the middle of the secretory phase, or at the beginning of the follicular phase. Stimulation of the ovaries with gonadotropins is initiated when downregulation is confirmed.

Administration of gonadotropins is usually started during the second or third week of treatment with GnRH agonists.The possibility of earlier initiation of the ovarian stimulation, if downregulation is confirmed at an earlier stage, has not been examined so far.

The purpose of this study is to assess whether the duration of pituitary downregulation with GnRH agonists, prior to initiation of ovarian stimulation with gonadotropins, has any effect on pregnancy rate, in women undergoing IVF.

Eligibility Criteria:
Inclusion Criteria:

* age under 39
* less than 3 previous IVF cycles
* BMI 18-29
* normal ultrasound of internal genital organs

Exclusion Criteria:

* polycystic ovarian syndrome
* endometriosis
Aplastic Anemia Epidemiology: Incidence and Case-control

To conduct incidence and case-control studies of aplastic anemia in metropolitan Bangkok, Thailand

BACKGROUND:

Aplastic anemia, a form of bone marrow failure, is a disease of largely unknown cause, except for the rare situations involving high doses of radiation. Many agents have been mentioned in case reports to be associated with the development of aplastic anemia and include drugs, chemicals, pesticides, radiation, and viral infection. Of these, chloramphenicol, phenylbutazone, and insecticides are most frequently reported. In the United States and other developed countries the disease prevalence is so low that too few cases occur to make an epidemiological study in a single city logistically feasible. The Bangkok hospitalization rate for aplastic anemia was sufficient to conduct a case-control study. Also, a study conducted in this locale provided information on drugs and chemicals not commonly used in developed countries.

DESIGN NARRATIVE:

All aplastic anemia cases in metropolitan Bangkok were located and verified in the forty hospitals that agreed to participate in the study. Incidence rates were calculated by age group and sex. In the case-control study, interviews were used to obtain comprehensive histories of drug, chemical, pesticide, radiation, viral infections, and other exposures, along with relevant demographic and medical history information in order to examine the association between and test hypotheses regarding suspected hazards and to estimate the risks of developing aplastic anemia. The basic epidemiologic features of aplastic anemia were described by characterizing these patients in terms of standard demographic variables, age, race, sex, and medical history. The degree of association between viral hepatitis and the development of aplastic anemia was estimated.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Study on the Effect of Sound Therapy on Chronic Primary Tinnitus

This study is to compare the effect of Cochleural Alternating Acoustic Beam Therapy(CAABT) and tinnitus masking therapy(TMT) on chronic primary tinnitus.Half of participants will receive CAABT, while the other half will receive TMT.

The patients with tinnitus will be collected with medical history, ear examination ,auditory function test and questionnaire survey.100 cases of chronic primary tinnitus will be selected as the research object.This study will be developed in the form of a blind randomized clinical trial.The study subjects will be divided into 2 groups by randomized method, with 50 cases in each group. Psychological acoustic test, Resting-state function magnetic resonance imaging（RS-fMRI) will be conducted.For 6 months, the patients will be treated with Cochleural Alternating Acoustic Beam Therapy（CAABT）and tinnitus masking therapy（TMT） respectively, followed by questionnaire survey, psychological acoustics test and RS-fMRI. The THI,VAS score, RS-fMRI ReHo value and low-frequency wave amplitude (ALFF) before and after the treatment will be compared. For those cases with poor results, the exchanged treatment will be performed for 6 months, followed by questionnaire survey, psychoacoustic test, RS-fMRI, and comparison of THI, VAS score, ReHo value and ALFF before and after treatment.All cases will be followed up for 1 year, and questionnaire survey will be conducted again.

Eligibility Criteria:
Inclusion Criteria:

* Ages between 18-75 years
* Tinnitus undergone for more than 6 months
* Continuous attack, single tone dominated, annoying tinnitus
* Able to cooperate with auditory function test and psychoacoustic test
* The main tinnitus frequency is from 125Hz to 8000Hz
* Willing to use the equipment daily during the test
* Willing and able to follow up regularly
* Ability to read and write Chinese, able to understand and complete questionnaires

Exclusion Criteria:

* Secondary tinnitus
* Pure tone audiometry shows conduction deafness or mixed deafness
* Tinnitus main frequency threshold \>60dB
* Receiving treatment for other tinnitus
* MRI contraindications
* Feeling uncomfortable with the treatment equipment or not being accepted
Identification of Pathways to Mitigate Immune-Related Adverse Events With Cancer Immunotherapy

This protocol is a prospective, observational study of participants receiving immunotherapy (checkpoint inhibitors, CPI) for cancer therapy, testing the hypothesis that patients with immune related cutaneous adverse events (ircAEs) have unique immunologic endotypes associated with polarized immune responses.


Eligibility Criteria:
Inclusion Criteria:

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male or female, \>18 yo
4. Diagnosis of solid tumor including, but not limited to, genitourinary/gynecologic, lung, gastrointestinal and melanoma
5. Receiving, or prior to starting on, a checkpoint inhibitor
6. Grade ≥ 2 ircAE (CTCAE v 5.0) (for cohort 1 only)
7. An indication for system corticosteroids or biologic therapies as determined by the treating physician (for cohort 1 only)
8. Life expectancy ≥ 12 weeks

Exclusion Criteria:

1. Daily use of systemic steroid treatment in the past 4 weeks (prednisone \>10mg a day or equivalent) except for indications other than the cutaneous adverse event, and/or as an anti-emetic pre- or post-chemotherapy infusions.
2. Enrollment in any investigational drug trial with a drug that has not been approved
3. Taking other checkpoint inhibitors beyond anti-PD-(L)-1 or anti-CTLA-4 not yet indicated/approved for use
4. Pregnancy
5. Known blood borne infectious disease
6. Current or pervious diagnosis of a leukemia or lymphoma
7. Unable to give consent for study participation
8. Life expectancy \< 12 weeks
9. Any other condition or diagnosis in the opinion of the investigator that would interfere with the study results
The Effect of Breaking up Sitting in the Workplace on Cardiometabolic Risk and Worker Productivity

This pilot randomized controlled trial (RCT) will examine the effect of a tailored workplace intervention based on interrupting sitting on work productivity, well-being and cardio-metabolic risk in office workers. The experimental group in the 8-week intervention will be prompted to alternate between sitting and standing while working. The ratio between sitting and standing will begin at 3:1 (two hours per day in an eight-hour day) and increase to 1:1 (four hours per day in an eight-hour day) by the end of the second week of the eight-week intervention.


Eligibility Criteria:
Inclusion Criteria:

* Full-time office employees from any ethnic background, PC/Android phone users, and recruited from two different work sites.

Exclusion Criteria:

* Pregnancy
* History of musculoskeletal complaint
* Non-ambulatory
* Having a planned holiday that would mean they would not be at work for more than two weeks during the 8-week intervention period.
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Inhalative Doses of BEA 2180 BR in Healthy Male Volunteers

Study to investigate safety and tolerability, pharmacodynamics (PD) and pharmacokinetics (PK) of BEA 2180 BR


Eligibility Criteria:
Inclusion Criteria:

1. Healthy males according to the following criteria (examined at the Screening Visit):

   Based upon a complete medical history, including the physical examination, vital signs (BP, PR), 12-lead ECG, clinical laboratory tests

   1.1 No finding deviating from normal and of clinical relevance

   1.2 No evidence of a clinically relevant concomitant disease
2. Age ≥30 and ≤55 years
3. BMI ≥18.5 and BMI \< 30 kg/m2 (Body Mass Index)
4. Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation

Exclusion Criteria:

1. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, or hormonal disorders
2. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
3. History of relevant orthostatic hypotension, fainting spells or blackouts
4. Chronic or relevant acute infections
5. History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the Investigator
6. Intake of drugs with a long half-life (\> 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
7. Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
8. Participation in another trial with an investigational drug within two months prior to administration or during the trial
9. Smoker (\> 10 cigarettes or \> 3 cigars or \> 3 pipes/day)
10. Inability to refrain from smoking during the trial
11. Alcohol abuse (more than 60 g/day)
12. Drug abuse
13. Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
14. Excessive physical activities (within one week prior to administration or during the trial)
15. Any laboratory value outside the reference range if indicative of underlying disease or poor health

Exclusion criteria specific for this study:

* Asthma or chronic obstructive pulmonary disease
* Glaucoma
* Urinary tract obstruction
* Occupational (professional) exposure to antimuscarinic substances
Interrogation of Exosome-mediated Intercellular Signaling in Patients With Pancreatic Cancer

The purpose of this study is to isolate and analyze exosomes, which are tiny carriers of important proteins and nucleic acids that serve as messenger systems in the blood and tissue. Blood and tissue from patients with pancreatic cancer will be compared with blood and tissue from patients with noncancerous pancreatic disease. Including patients without cancer will allow the investigators to establish "normal" values, which currently do not exist. The investigators will then look to see whether exosome activity has a connection to disease recurrence and outcomes in patients. The results of this study will be the basis for future studies exploring this area.


Eligibility Criteria:
Inclusion Criteria:

* All patients ≥ 18 years of age undergoing pancreaticoduodenectomy, partial or complete pancreatectomy, and duodenal ampullectomy for presumed ductal adenocarcinoma, intraductal papillary mucinous neoplasm (IPMN) or pancreatic neuroendocrine tumors, without an invasive component; or other benign pancreatic disease will be eligible.
* For third part of the study, recipient of neoadjuvant chemotherapy will be accrued to the neoadjuvant group (25 patients). Patients without neoadjuvant chemotherapy will be accrued to the non-neoadjuvant group (25 patients).

Exclusion Criteria:

* The presence of metastatic disease or disease that precludes resection
* For first and second part of the study, receipt of neoadjuvant chemotherapy or radiation for the index cancer within 6 months of being enrolled in the study
* For third part of the study, receipt of neoadjuvant radiation for the index cancer within 6 months of being enrolled in the study
* INR \>2
* Known clotting factor deficiency or hypercoagulable state
* Any patient with the need or anticipated need for full anti-coagulation during hospitalization for the resection.
* Receipt of antiplatelet agents (other than aspirin) in the preceding week prior to resection.
* IPMN or pancreatic neuroendocrine tumors by radiographic imaging with high suspicion for invasive component Additionally, if at the discretion of the operating surgeon, blood collection would lead to undue morbidity, the patient will be excluded and replaced
A Study of the Efficacy and Safety of RWJ-333369 as add-on Therapy in the Treatment of Partial Onset Seizures.

The purpose of this study is to demonstrate that RWJ-333369 is safe and effective as add-on treatment of partial onset seizures.

According to the World Health Organization (WHO), epilepsy afflicts more than 50 million people worldwide. Despite the ongoing use of older antiepileptic drugs (AEDs) and the development of newer treatments that are better tolerated, approximately 30% of patients, particularly those with partial seizures, are not well controlled even on newer treatments, or experience significant side effects from treatment. RWJ-333369 is a drug with anticonvulsant activity that is being investigated for the treatment of epilepsy. This is a randomized (patients are assigned different treatments based on chance), double-blind study (neither the patient nor the physician knows whether drug or placebo is being taken, or at what dosage ) in males and females who have partial onset seizures that have had an inadequate response to at least one AED. The study consists of 3 phases: pretreatment (a screening visit and a 56-day baseline period), double-blind treatment (12 weeks of treatment with either 200 mg per day of RWJ-333369, 400 mg per day of RWJ-333369, or placebo), and posttreatment (a posttreatment visit that occurs 7 to 14 days after the last dose of double-blind study drug). The posttreatment phase is only for patients not continuing in the open-label extension study. The open-label extension study is offered after completion of the double-blind treatment phase if the study doctor judges that the patient may benefit from continued treatment with RWJ-333369. The open-label extension study lasts until RWJ-333369 becomes available by prescription or its development is stopped by the sponsor. The efficacy of the RWJ-333369 will be based on a change in the frequency and severity of seizures. Safety assessments include adverse events (side effects) reporting, collecting blood tests and Electrocardiograms and performing physical exams, including vitals signs. The study hypothesis is that 400 mg per day of RWJ-333369 is better than placebo as add-on treatment of partial onset seizures, as measured by the percent reduction from baseline in the monthly partial onset seizure frequency. 200 mg per day RWJ-333369, 400 mg per day RWJ-333369, or placebo, given twice daily with or without food approximately 12 hours apart; study drug should be swallowed whole and not be chewed, divided, crushed, or dissolved.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female, 16 year or older
* Clinical diagnosis of focal epilepsy for at least 1 year
* History of poor response to at least 1 anti-epileptic drug in the past
* Current treatment with 1 or 2 anti-epileptic drugs
* Should have at least 3 seizures per month

Exclusion Criteria:

* Generalized epilepsy
* Cannot count your seizures
* Unstable medical disease, such as a recent heart attack or uncontrolled diabetes
* Major psychiatric illness
* Recent drug or alcohol abuse
* Unable to swallow pills