cyrilzakka/clinical-trials huggingface dataset:
The Effect of Breathing Helium-Hyperoxia During Pulmonary Rehabilitation in Patients With COPD

The purpose of this study is to examine whether breathing helium-hyperoxia during exercise in a pulmonary rehabilitation program can improve the exercise tolerance and health related quality of life of patients with Chronic Obstructive Pulmonary Disease (COPD).

It is well accepted that the exercise training as part of a comprehensive pulmonary rehabilitation program can improve exercise tolerance, functional status and quality of life in patients with COPD. It is feasible that if patients were able to perform a greater volume or intensity of exercise during rehabilitation then the outcomes of the program would be improved. Recent research has demonstrated that breathing a helium-hyperoxic gas mixture can significantly reduce dynamic hyperinflation and dyspnea during exercise in patients with COPD and can increase exercise tolerance to a greater extent than breathing room air or a nitrogen-based hyperoxic gas. If patients with COPD were to breathe a helium-hyperoxic gas during exercise they should be able to tolerate a greater intensity of exercise while maintaining similar levels of exertional symptoms to those observed at lower exercise intensities breathing room air. As a result patients randomized to the helium-hyperoxia condition should obtain greater improvements in exercise tolerance than those receiving usual care (i.e. breathing room air)

Comparisons: Standard pulmonary rehabilitation of patients with COPD receiving either usual care (air breathing) or helium-hyperoxia (40% O2, 60% Helium).

Eligibility Criteria:
Inclusion Criteria:

* FEV1/FVC\<70% predicted;
* FEV1\<70% predicted;
* RV\>140% predicted.

Exclusion Criteria:

* Cardiovascular contraindications to exercise;
* Musculoskeletal abnormalities that limit exercise tolerance;
* SpO2\<85% during a constant work rate test;
* On supplemental oxygen.
* Exacerbation within the last month
Guided Imagery in the Perioperative Period in Gynecologic Oncology Patients

The purpose of this study is to evaluate the effectiveness of self-administered perioperative guided imagery to reduce perioperative distress in gynecologic oncology patients undergoing surgical management for a presumed cancer diagnosis.


Eligibility Criteria:
Inclusion Criteria:

* Undergoing surgical management for a suspected diagnosis of Gynecologic Malignancy (Endometrial, Ovarian, Vulvar, Vaginal, Primary Peritoneal, Fallopian Tube)
* Age 18 or greater
* Receiving care at University of Michigan Comprehensive Cancer Center Gynecologic Oncology Clinic or at St. Joseph Mercy Hospital, Alexander Cancer Care Center
* Able to understand and read English
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
* Patients must have working telephone, mobile or land line

Exclusion Criteria:

* Severe hearing impairment that limits the ability to use audio-based guided imagery modules
* Current documented alcohol abuse or illicit drug substance abuse
* Planned outpatient surgery
* Patients currently participating in a meditation practice for more than 1 hour per week prior to preoperative visit.
Treatment Parameters for the Empower Neuromodulation System (ENS)

The subject will be administered a treatment at a treatment location and then be asked if he/she believes it is the active treatment, sham treatment, or does not know. A clinical-grade nerve conduction assessment system will be used both to provide electrical stimulation at four locations to record peripheral responses. The subject will self-administer two treatment sessions at two active treatment sites.


Eligibility Criteria:
Inclusion Criteria:

1. Is 21-75 years old
2. Can provide informed consent
3. Currently has a stable living situation
4. Had one heavy drinking week (\>7 drinks/week for women; \>14 drinks/week for men) over the past 6 months
5. Has a breath alcohol concentration of 0.00% at enrollment
6. Is willing to follow all study procedures

Exclusion Criteria:

1. Has been diagnosed with schizophrenia, epilepsy, peripheral neuropathy, or nerve damage
2. Has implanted electrical and/or neurostimulator device (e.g. pacemaker, defibrillator, vagal neurostimulator, deep brain stimulator, spinal stimulator, sacral stimulator, bone growth stimulator, or cochlear implant)
3. Has a tattoo or conductive, ferromagnetic, or other magnetic-sensitive metals that cannot be removed from the hand, wrist, or biceps
4. Is currently pregnant or breastfeeding
5. Has a bleeding disorder, a history of deep vein thrombosis, or is on anticoagulation drugs
6. Has used an investigational drug/device therapy within the past 4 weeks
7. Is deemed unsuitable for enrollment in study by the PI
Emotional and Cognitive Self-regulation, an EEG Study

The main goal of the proposed project is to assess treatment-induced changes of electrophysiological and psychophysiological correlates of the capacity to regulate emotion, executive functions, and clinical measures in individuals with complex posttraumatic stress disorder and dissociative disorders in a naturalistic inpatient setting.


Eligibility Criteria:
Inclusion Criteria:

-ability to undergo EEG measurement/psychophysiological measurement

Exclusion Criteria:

* regular substance use
* acute suicidality
* comorbid psychosis
Efficacy of Acupuncture in Patients Post-Covid Brain Fog

After being infected with Covid-19, many people developed to Brain fog. The treatment strategy now is based on the presumed pathological phenomenon and the physician's clinical experience. Acupuncture has been used to improve cognitive dysfunction caused by central nervous system diseases for many years.

A randomized rater-blinded controlled study is proposed to see the efficacy of acupuncture for brain fog.

After being infected with Covid-19, many people develop cognitive dysfunction, including deficits in attention, executive ability, language, processing speed, and memory. These symptoms are collectively known as Brain fog or Covid fog.

The pathological mechanism of the cognitive deficit is inconclusive. Therefore, the treatment strategy is based on the presumed pathological phenomenon and the physician's clinical experience. Acupuncture has been used to improve cognitive dysfunction caused by central nervous system diseases for many years. This study aims to evaluate the medium and long-term clinical efficacy of acupuncture in patients with post-Covid related Mild cognitive impairment (MCI).

A randomized rater-blinded controlled study is proposed. Eligible patients were over 18 years old and \<65 years old. These patients were diagnosed with Covid-19 more than 12 weeks earlier and developed mild cognitive impairment (MCI) after the diagnosis of Covid-19. Divided into the acupuncture group and the sham acupuncture group for an 8-week course of treatment, the Mini-Mental State Examination (MMSE), the quality of life assessment scale The 5-level EQ(EuroQol Group)- five dimensions version(EQ-5D-5L) and The Stroop Color and Word Test evaluates the degree of cognitive impairment and the impact of cognitive impairment on quality of life and attention.

Eligibility Criteria:
Inclusion Criteria:

1. Have been tested positive for severe acute respiratory syndrome coronavirus 2(SARS-CoV-2) or had serum antibody positivity more than 12 weeks before.
2. Present cognitive impairment after been diagnosed as Covid-19
3. Clinical Dementia Rating (CDR) score of 1
4. Normal activities of daily living score (ADL)
5. (Mini-Mental State Examination) MMSE score of 24-28
6. Age of 18-65 years
7. Signed informed consent

Exclusion Criteria:

1. Diagnosed with any type of dementia.
2. A history of acute or chronic cerebrovascular disease, encephalitis, Parkinson's disease, Leukoencephalopathy, and other central nervous system diseases
3. A history of hypothyroidism, vitamin B12 deficiency, depression, syphilis, and other diseases that may affect cognitive decline.
4. Severe hearing and visual impairment, inability to complete neuropsychological tests
5. Impaired liver and kidney function and hematopoietic system disorders
Rituximab for HTLV-1-associated Myelopathy

Neuroprotective or anti-inflammatory strategies are invaluable in HTLV-1-associated myelopathy due to its rapid progression. We evaluated the efficacy of rituximab in patients with HTLV-1-associated myelopathy.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-80 years
* Patients HTLV-1-associated myelopathy (tropical spastic paraparesis)

Exclusion Criteria:

* Anticipated survival of at least 3 years
* Inability to undergo neuroimaging with Magnetic Resonance
* Clinically significant hepatic disease as demonstrated by history, clinical exam (ascites, varices), or laboratory findings (LFTs \>2x normal, coagulopathy as described)
* Comorbid conditions likely to complicate therapy including but not limited to the following: a history of New York Heart Association class II, III, or IV Congestive Heart Failure; end-stage acquired immune deficiency syndrome
* Pregnancy
* Malignancy (history of or active)
* Concomitant use with antineoplastic, immunosuppressive or immune modulating therapies
Sevoflurane and Hyperperfusion Syndrome

The aim of the present study is to evaluate the effect of sevoflurane postconditioning on the incidence of postoperative hyperperfusion syndrome following revascularization surgery in moyamoya patients.

Postoperative hyperperfusion syndrome is a common complication in moyamoya disease patients receiving revascularization surgery. Previously its incidence has been reported to be 17\~50%, but little remains regarding frequency of reperfusion injury after revascularization surgery in patients with moyamoya disease. Volatile anesthetics such as sevoflurane has been introduced clinically to reduce reperfusion injury and preconditioning with sevoflurane induced ischemic tolerance like as ischemic preconditioning. However, there was no report on the neuroprotective effect of sevoflurane postconditioning on ischemic/reperfusion injury in human brain. Therefore, We evaluated the neuroprotective effect of sevoflurane postconditioning on the incidence of postoperative hyperperfusion syndrome after revascularization surgery in moyamoya disease patients.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients receiving cerebral revascularization surgery due to moyamoya disease

Exclusion Criteria:

* Patients who do not agree to the study
* Patients with uncontrolled diabetes or hypertension
* Patients using cyclooxygenase2 inhibitor or with previously using cyclooxygenase2 inhibitor
* Patients with acute renal failure
* Patients with previous intervention related with moyamoya disease
Phase 3 Trial in Subjects With Metastatic Melanoma Comparing 3 mg/kg Ipilimumab Versus 10 mg/kg Ipilimumab

The purpose of this study is to determine whether giving Ipilimumab at a dose of 10mg/kg will extend the lives of subjects with unresectable or metastatic melanoma more than giving Ipilimumab at a dose of 3 mg/kg


Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

* Unresectable Stage III or Stage IV melanoma
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria:

* Brain metastases with symptoms or requiring treatment
* History of autoimmune disease
Azithromycin for Child Survival in Niger II

Several randomized controlled trials have demonstrated that azithromycin mass drug administration (MDA) reduces child mortality, but increases antimicrobial resistance (AMR). The World Health Organization (WHO) guidelines for this intervention specify that implementation must be accompanied by continued monitoring of mortality and AMR. Niger is expanding the azithromycin MDA program nationwide. To establish monitoring of mortality and AMR as part of this program as well as to leverage the infrastructure to evaluate other child health interventions, AVENIR II is designed as an adaptive platform trial with monitoring and re-randomization every 2 years.

AVENIR II is a cluster-randomized adaptive platform trial designed to evaluate community health interventions in Niger. The initial focus is to monitor under-5 mortality and antimicrobial resistance as the azithromycin MDA for child survival program expands in Niger, with the following specific aims:

1. Mortality.

   1. To conduct surveillance of mortality over time compared to the Sustainable Development Goal targets for under-5 mortality reduction. As this intervention is not intended to continue indefinitely, surveillance against a target is needed to determine when to stop.
   2. To continue to evaluate the effectiveness of azithromycin MDA to reduce under-5 mortality. Given the risk of AMR, the effectiveness of the intervention over time is needed to fully weigh the risks against the benefits.
2. Antimicrobial Resistance. To determine the impact of azithromycin MDA on AMR in population- and clinic-based samples.

Eligibility Criteria:
Inclusion Criteria:

CSI-level for mortality and AMR monitoring:

* Located in a region participating in the program
* Designated as rural by local study team
* Selected for participation in monitoring activities
* Safe and accessible for study teams
* Verbal approval from community leaders

Individual level for mortality monitoring:

* Residing in the catchment area of an eligible CSI
* Selected for participation in monitoring activities
* Female
* Age between 12 and 55 years old
* Verbal approval from participant

Individual-level for AMR monitoring:

* Residing in the catchment area of an eligible CSI
* Selected for participation in monitoring activities
* Age between 1 and 59 months old
* Verbal approval from a caregiver or guardian

Exclusion Criteria:

At the community-level:

* Designated as urban by local study team
* Inaccessible or unsafe for study team

At the individual-level:

* Known allergy to macrolides
Adults With SMA Treated With Nusinersen

This is a single center, 22-month observational study of nusinersen treatment in adult patients with spinal muscular atrophy (SMA). There will be a total of seven visits. Nusinersen is provided as standard of care and not considered research in this study. Information will be collected regarding the general health, and function including muscle strength of, as well as any positive and/or adverse events experienced by the study participants.

This is a single center, 22-month observational study of nusinersen treatment in adult patients with SMA. There will be a total of five visits. All subjects will be evaluated at a screening visit no more than four weeks before starting their standard of care nusinersen treatment to determine their eligibility for participation. Eligible patients will complete their standard induction intrathecal nusinersen treatment on day 1, 15, 29 and 60 followed by maintenance doses every four months. Subjects will be reevaluated after completing the loading doses at 2 months followed by every four-month evaluations for the total duration of the treatment of 22 months.

Currently, there is no data published on patients receiving this treatment over the age of 18. Without published data collected from research, it is difficult for adult patients to get approval from their insurance companies to receive this treatment. This study hopes to collect data, in order to make this treatment option easier for patients with SMA to access and in general learn how well nusinersen is working in adult patients with SMA overtime.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 to 60 years
2. Genetic confirmation of 5q SMA documented by the homozygous deletion of both SMN1 genes on standard genetic tests for the disorder
3. SMN2 copy number of 3 or greater
4. Subjects must be able to walk thirty feet without assistance (i.e. no canes, walkers)
5. Interest in participating and the ability to meet the study requirements
6. Women of childbearing-age are required to be on birth control or abstain while participating in the research study

Exclusion Criteria:

1. Subjects with history of spinal disease that will interfere with the lumbar puncture procedure
2. Subjects with history of bacterial meningitis or encephalitis
3. Subjects with history of use of investigational drug treatment for SMA in the last six months, or plan on enrolling in any other treatment trial during the duration of this trial
4. History of treatment with gene therapy, stem cell or antisense oligonucleotide
5. Patients with co-morbid conditions that preclude travel, testing or study medications
6. Patients who are, in the investigator's opinion, mentally or legally incapacitated from providing informed consent for the study, or are otherwise unable to meet study requirements or cooperate reliably with study procedures, especially strength testing
7. Women who are pregnant or who intend to become pregnant while participating in the research study or who are breastfeeding
High-Flow Needleless Valve and DualCap Disinfection Devices Associate With Catheter-related Bloodstream Infection

The purpose of this study is to investigate whether the usage of High-Flow Needleless Valve and DualCap Disinfection Devices would reduce the incidence of catheter-related bloodstream infection in hemodialysis patients.


Eligibility Criteria:
Inclusion Criteria:

* Implanted non-tunneled cuff catheter for any reason and going on blood purified therapy in our centre
* Have signed information consent form

Exclusion Criteria:

* Have got bacteremia before catheter implantation
* Catheter changing in situ
Effect of Laser in Treatment of Vulval Warts

Vulval warts is a magor problem that affects women .

The causative organism for vulval warts is human papilloma virus There are many treatment modalities that can trat these warts

Eligibility Criteria:
Inclusion Criteria:

* women who have vulval warts
* Age between 18- 40 years

Exclusion Criteria:

* warts that were previously treated by surgery or cryotherapy
Effect of Multimodal Analgesia on Pain With Insertion of Levonorgestrel-releasing IUD

Does the addition of cervical lidocaine injections and valium to the current practice result in decreased reported pain with tenaculum placement, IUD insertion, and post procedural discomfort? The current practice is ibuprofen alone or no medication.

Long acting reversible contraception, including intrauterine devices (IUDs), provide birth control for an extended period of time. IUDs are the most effective type of reversible birth control for women who do not wish to become pregnant over the next couple years, have the lowest failure rate (Winner, 2012), and in 2007, were used by more than 180 million women worldwide (Darney, 2010). Despite the high efficacy and low rates of side effects, women may decline placement of an IUD due to fear of pain associated with placement. IUDs may act as a barrier to women selecting this method of contraception. Currently there is no consensus in the literature as to the most effective way to address analgesia surrounding IUD insertion.

In order to eliminate barriers to selecting the IUD for contraception, improve the experience of women undergoing placement, and standardize local practices, investigators want to investigate analgesic options affecting patients' perception of pain during the various steps of IUD insertion.

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years of age,
* Desires to undergo placement of a levonorgestrel containing intrauterine device

Exclusion Criteria:

* Device manufacturer contraindications such as signs of genital infection, positive urine pregnancy test, abnormal vaginal bleeding, abnormal sized uterus that sounds \<6cm or \>10cm, and all other contraindications to placement of a levonorgestrel containing IUD.
* Patients with a history of drug abuse.
* History of a prior IUD
* Current use of medications for anxiety
* Also, a diagnosis of chronic pain.
Laser and Microdermabrasion Before Photodynamic Therapy for Actinic Keratoses in Field-cancerized Skin

Comparison of treatment efficacy and safety of pretreatment with ablative fractional laser versus microdermabrasion combined with large-area photodynamic therapy with methyl aminolevulinate for actinic keratoses

For each study participant, two test areas (A and B) are demarcated in the same anatomical region, with each area containing no less than 5 actinic keratoses (AKs). Test areas are randomized to receive skin pretreatment of EITHER ablative fractional laser OR microdermabrasion prior to photodynamic therapy using methyl aminolevulinate.

Efficacy, local skin reactions and safety of both test areas are evaluated over a 12-15 week follow up period.

Eligibility Criteria:
Inclusion Criteria:

* Patients with two skin areas of at least 50 cm2 with a minimum of 5 actinic keratoses (AKs) grade I-III, chronically sun damaged "field" changes in one of the following anatomical regions: face, scalp, upper chest.
* Patients who have given written informed consent and are believed to be capable of following the study protocol.
* Fertile women must have a negative pregnancy test (urine-hCG) at the time of inclusion and use anti-contraception (oral contraceptives, intrauterine device, gestagen depot injection, subdermal implantation, vaginal ring, transdermal depot bandage or sterilisation) during the study.

Exclusion Criteria:

* Patients that have within the last month received local treatment in the test areas.
* Pregnant or nursing patients.
* Patients with porphyria
* Patients with skin cancer, keratoacanthoma, or other infiltrating tumors within the test areas.
* Patients with a tendency to develop hypertrophic scars or keloids.
* Patients with a known allergy to Metvix cream
* Patients that are believe unlikely to follow the study protocol.
Comparison of Femoral Versus Jugular Routes for Temporary Hemodialysis in Seriously Ill Patients

The purpose of this study is to determine whether a jugular route leads to a lower rate of complications as compared with a femoral route for catheterization in patients admitted in several intensive care units in France who develop acute renal failure requiring hemodiafiltration or hemodialysis.


Eligibility Criteria:
Inclusion Criteria:

* Admitted in intensive care unit (ICU)
* Requiring hemodialysis
* Clinicians have the choice between jugular and femoral routes

Exclusion Criteria:

* Chronic renal failure requiring long term dialysis