cyrilzakka/clinical-trials huggingface dataset:
Asthma and Osteopathic Manipulative Treatment

The effect of Osteopathic Manipulative Treatment (OMT) has been studied in adult patients with chronic obstructive pulmonary disease (COPD) and children with asthma, however, to the authors' knowledge, no current studies have evaluated the non-immediate effects of OMT on pulmonary function in adults with chronic asthma using spirometry. The objective of the current study was to quantify the immediate, intermediate, and long-term effects of OMT on adult patients with a history of asthma. The quantitative effects were measured with a spirometry device and include the forced expiratory volume in one second (FEV1), the forced vital capacity (FVC), the FEV1/FVC ratio, and the peak expiratory flow (PEF). These four values are used clinically in the diagnosis and management of asthma. The long-term, subjective effects were measured via the Asthma Quality of Life Questionnaire with Standardized Activities (AQLQ(S)).

The study was conducted over a period of eight weeks. During week 0, participants completed the initial AQLQ and performed baseline spirometry testing. During weeks 1, 2, and 3 of the study, a standard OMT protocol was performed on each participant, followed by spirometry testing to measure the immediate effect. Spirometry testing was then performed again three days after each treatment to measure the intermediate effect of OMT. During week 7, participants completed the post-OMT AQLQ(S) and performed spirometry testing once more to measure the long-term effects of OMT. The OMT protocol performed on each patient included treatments to address somatic dysfunctions of the head, cervical spine, thoracic spine, ribs, and respiratory diaphragm. The authors hypothesized that OMT would improve pulmonary function, both subjectively and objectively. The authors predicted an increased overall mean AQLQ(S) score as well as an increased mean score within each domain, including symptoms, activity limitations, emotional function, and environmental stimuli. The authors also predicted a significant increase in the mean FEV1/FVC ratio, and PEF three days after each OMT session and a significant increase four weeks after the final OMT session, but no increase immediately after OMT.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* previously diagnosed with asthma

Exclusion Criteria:

* Current smoker
* Diagnosed with any other respiratory disease besides asthma
* Receiving OMM from a licensed physician, chiropractic treatment, or massage therapy for 30 days prior to and during the study
Study Comparing In-laboratory Polysomnography Electrocardiogram (PSG ECG) to Simultaneously Recorded In-laboratory ECG on the CPC M1 Device

Research study that will test a portable device (CPC M1) that records: body movement; heart activity (ECG; snoring; and body position during sleep. The Food and Drug Administration (FDA) has not approved this device for use except in a research setting.

The purposes of this study are to: a) determine if the ECG data collected using the CPC M1 device is at least as good as the ECG data collected during a diagnostic, in-lab polysomnogram (PSG) (or sleep study) and b) determine if in-home monitoring with the device will provide similar results compared to an in-lab PSG.


Eligibility Criteria:
Inclusion Criteria:

1. Adults (males and females) 18 to 70 years of age with a suspected sleep disorder.
2. Subjects or legal guardians are able to verbalize an understanding of the consent form, provide written informed consent, and verbalize willingness to complete study procedures.
3. Adequate dexterity to apply and remove the CPC M1 device.

Exclusion Criteria:

1. Patients with atrial fibrillation and ventricular tachycardia.
2. Patients with an inability to apply the CPC M1 device.
3. Pregnancy.
Evaluation of Serum Interleukin-15 and Interleukin-22 Levels in Patients With Non-segmental Vitiligo

Evaluation of Serum Interleukin-15 and Interleukin-22 Levels in Patients with Non-segmental Vitiligo before and after phototherapy

This prospective study will include 30 patients with NSV, attending the Outpatient Clinics of Dermatology at Sohag University Hospitals, as well as 30 normal volunteers as control.

This study will be submitted for approval by Research and Ethical committees at Sohag Faculty of Medicine. An informed written consent will be obtained from each subject prior to participation in the study after full explanation of the procedure.

Eligibility Criteria:
Inclusion Criteria:

* • Patients suffering from non segmental vitiligo.

  * Patients not on medical treatment or phototherapy for vitiligo in the last 3 months.

Exclusion Criteria:

* • Patients with systemic or cutaneous inflammatory disorders.

  * Patients on treatment for vitiligo in last 3 months.
  * Pregnant and lactating patients.
  * Patients with history of diabetes.
  * Patients with history of autoimmune diseases.
Erythropoietin Gel Effect on Dental Implant Stability

* Achieving and maintaining long-term osseointegration for dental implants is a key objective in the field of dentistry. The success of osseointegration is influenced by the surface treatment applied to dental implants. Numerous coating techniques have been developed to improve and speed up osseointegration.
* The aim of the current study is to assess immediate dental implant stability coated with erythropoietin gel, both clinically and radiographically.
* Materials and Methods: We conducted a randomized controlled clinical trial.The sample will include patients demanding immediate implant treatment in the anterior maxilla . Patients will be randomly allocated into the two groups of the study. The group A will be treated with erythropoietin gel coated dental implant immediately after extraction of non restorable teeth in the anterior maxilla . Group B will be treated with non coated dental implant immediately after extraction of non restorable teeth in the anterior maxilla .
* The primary outcome variable will be implant stability and the secondary outcome will be crestal marginal bone level and bone density around implants. It will be measured at time of implant placement and reevaluated after 6-months .


Eligibility Criteria:
Inclusion Criteria:

* All patients Should have nonrestorable teeth in the anterior maxilla indicated for extraction and seeking implant placement.
* Good general periodontal health and maintenance.

Exclusion Criteria:

* Heavy smokers who smoke more than ten cigarettes per day
* Acute infected socket
* Ant socket with wall defect.
* Pregnency
* Local or systemic conditions that will interfere with bone healing (uncontrolled diabetes mellitus or human immune deficiency virus infections, resonance therapy), bone disorders (hyperparathyroidism, osteoporosis, or Paget's disease.
* Patients who had subjected to intravenous and/or oral bisphosphonate therapy.
Post-operative Cognitive Function Following Pelvic Floor Surgery

The aim of this study is to assess cognitive function before and after surgery for pelvic organ prolapse using sensitive tests of various neurocognitive domains.

Post operative cognitive dysfunction has been well described as a relatively common phenomenon with potentially long-lasting detrimental effects. However, there are currently limited data exploring the effects of gynecologic surgery on cognitive function. The population of patients treated surgically for pelvic floor disorders is typically older, and therefore at higher baseline risk for cognitive dysfunction. Therefore, it is of interest to determine the effects of pelvic floor surgery and anesthesia on this patient population. The investigators plan to conduct a prospective cohort study to assess cognitive function before and after pelvic organ prolapse surgery using sensitive tests of memory and other neurocognitive domains. Participants will be women undergoing surgery for pelvic organ prolapse. All participants will undergo cognitive tests at three time points: at their pre-operative clinic appointment, in the hospital the morning after surgery, and at their post-operative clinic appointment. In addition to the neurocognitive tests, patients will undergo a series of questionnaires regarding physical function, frailty, sleep quality, and incontinence symptoms.

Eligibility Criteria:
Inclusion Criteria: Women 60 years of age or older who are scheduled to undergo surgery for pelvic organ prolapse.

Exclusion Criteria:

* Women who have a known baseline diagnosis of cognitive dysfunction or central nervous disorder
* A Mini-Mental State Exam (MMSE) score of greater than 24
* Non-english speaking
* Any severe visual or auditory disorder
* Alcoholism or drug dependence
COPD Circuit Exercise

This study is being done to understand body's response to hybrid home-based and on-site rehabilitation program utilizing individually tailored exercises throughout a total of 18 sessions with 12 of them occurring onsite, in people with and without chronic respiratory diseases, such as Chronic Obstructive Pulmonary Disease (COPD) and Obstructive Sleep Apnea (OSA) and in individuals recovered from COVID-19. Exercise training programs vary widely for people with COPD, OSA, and during prolonged recovery from COVID infection. This study will help identify if this program is helpful to address muscle loss and fatigue specifically in populations with and without chronic respiratory diseases.


Eligibility Criteria:
Inclusion Criteria:

* Ability to walk, sit down and stand up independently

  * Age 30 - 85 years
  * Ability to lay in supine or elevated position for up to 3 hours
  * Diagnosis of moderate to very severe chronic airflow limitation and compliant to the following criteria: FEV1 \< 70% of reference FEV1

-or- Obstructive Sleep Apnea (OSA)

-or- 2 weeks post-recovered\* from laboratory confirmed case of COVID

● Willingness and ability to comply with the protocol

\*Recovered is defined according to Brazos County Health District as someone who has been fever-free for 24 hours without fever-reducing medications, and it has been 10 days after onset of symptoms.

Inclusion criteria control subjects

* Healthy male or female according to the investigator's or appointed staff's judgment
* Ability to walk, sit down and stand up independently
* Age 30 - 85 years
* Ability to lay in supine or elevated position for up to 3 hours
* No diagnosis of chronic lung disease
* Willingness and ability to comply with the protocol

Exclusion Criteria:

* Unable to exercise due to physical limitations (i.e. neuromuscular and/or orthopedic disorders)

  * Established diagnosis of malignancy
  * Presence of acute illness or metabolically unstable chronic illness
  * Presence of fever within the last 3 days.
  * Expected to have surgery within 1 month of screening or during exercise training
  * Any other condition according to the PI or research staff that was found during the screening visit, that would interfere with the study or safety of the patient.
  * Previous injury that could interfere with participation in resistance exercise protocol.
  * Failure to give informed consent or Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements.
  * (Possible) pregnancy.
  * Already enrolled in another clinical trial and that clinical trial interferes with participating in this study. When during the period from enrollment to the test day any condition causing the subject to not meet inclusion criteria or to meet exclusion criteria, the subject will be excluded from the study.
The Safety and Effectiveness of Cidofovir in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients With AIDS

To determine whether cidofovir (HPMPC) therapy administered by intravenous infusion can extend the time to progression of peripheral cytomegalovirus (CMV) retinitis in AIDS patients. To evaluate the safety and tolerance of HPMPC therapy when administered by intravenous infusion in AIDS patients with CMV retinitis that is not immediately sight-threatening. To evaluate the virologic effects of intravenous HPMPC therapy on CMV shedding in urine, blood, and/or semen. To evaluate the impact of HPMPC therapy on visual acuity.

Patients are randomized to one of two treatment arms. Group A receives HPMPC by IV infusion weekly for 2 consecutive weeks (induction) and then every other week (maintenance) with oral probenecid and IV hydration. Group B receives no treatment until the time of retinitis progression (deferred treatment), at which time they receive the same regimen as Group A, provided retinitis progression is not immediately sight-threatening.

Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed:

* Antiretroviral agents.
* Oral trimethoprim/sulfamethoxazole.
* Aerosolized pentamidine.
* Dapsone.
* Fluconazole.
* Rifabutin.
* Filgrastim (G-CSF).
* p24 vaccine.

Patients must have:

* Diagnosis of AIDS by CDC criteria.
* Diagnosis of peripheral (not immediately sight-threatening) CMV retinitis.
* Visual acuity in the affected eye of \>= three lines on the ETDRS (Early Treatment Diabetic Retinopathy Study) chart at 1 m distance.
* Life expectancy of at least 3 months.
* Consent of parent or guardian in patients less than 18 years of age.

Prior Medication:

Allowed:

* Acyclovir.
* Prior ganciclovir, foscarnet, or CMV hyperimmune immunoglobulin if given solely as prophylaxis.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Media opacity that precludes visualization of the fundus of both eyes.
* Retinal detachment.
* Clinically significant cardiac disease, including symptoms of ischemia, congestive heart failure, or arrhythmia.
* Active medical problems considered sufficient to hinder study compliance.
* Known clinically significant allergy to probenecid.

Concurrent Medication:

Excluded:

* Acyclovir (may be reinstituted following development of herpetic lesions).
* Ganciclovir.
* Foscarnet.
* Amphotericin B.
* Diuretics.
* Aminoglycoside antibiotics.
* CMV hyperimmune immunoglobulin.
* Intravenous pentamidine.
* Other nephrotoxic agents.
* Other investigational drugs with potential nephrotoxicity.

Prior Medication:

Excluded:

* Prior ganciclovir, foscarnet, or CMV hyperimmune immunoglobulin as therapy for CMV disease (although permitted if previously received solely as prophylaxis).

Excluded within 1 week prior to study entry:

* Amphotericin B.
* Vidarabine.
* Other nephrotoxic agents.
* Aminoglycoside antibiotics.
* Intravenous pentamidine. Drug or alcohol abuse.
Nutritional Status Assessment in the Elderly Suffering From Cancer : a National Cross-UCOG Survey

Protein-energy malnutrition (PEM) is a frequent condition in patients suffering from cancer, especially the elderly. According to some studies, this malnutrition has important consequences in this population, by increasing the risk of treatment toxicities, premature interruption of chemotherapy, mortality and risks of complications. Identifying cases of malnutrition is an objective pursued by the National Nutrition and Health Programme and an important task of the "Unités de Coordination en Oncogériatrie".

The main goal of this study is to assess the loss of weight over the 6 month-period preceding the cancer treatment, regardless of kind (chemotherapy, targeted therapy, hormone therapy, immunotherapy, radiation therapy, surgery, comfort care), in the elderly suffering from cancer.


Eligibility Criteria:
Inclusion Criteria:

* Over 70 years of age
* Suffering from cancer
* Waiting for a treatment decision (whatever it is)
* Hospitalized in a hospital or come to consult in a hospital during the period of inclusion (2 periods of 6 weeks for two consecutive years)
* Affiliated to a social security system

Exclusion Criteria:

* Patient unable to receive information regarding the study and/or provide its non objection regarding the use of its data
* Patient under tutorship or curatorship, deprived of freedom or placed under judicial protection
Efficacy and Safety of Ivabradine to Reduce Heart Rate Prior to Coronary CT-angiography in Advanced Heart Failure: Comparison With β-Blocker

The aim of this study is to compare the effects of Ivabradine and metoprolol to reduce heart rate prior to coronary CT angiography in patients with advanced heart failure.


Eligibility Criteria:
Inclusion Criteria:

* Sinus rhythm
* Heart rate \>60/min

Exclusion Criteria:

* Atrial fibrillation
* Any contraindication for beta-blocker use
Emotional State Among Patients With Neurological Disorders

The purpose of the study was to examine the emotional state of the patients with neurological disorders. The evaluation was conducted with DASS-21 scale over 40 patients.

The Depression, Anxiety and Stress Scale - 21 Items (DASS-21) is a set of three self-report scales designed to measure the emotional states of depression, anxiety and stress.The DASS-21 should not be used to replace a face to face clinical interview.

Eligibility Criteria:
Inclusion Criteria:

* patients with neurological disorders

Exclusion Criteria:

* not given concent
* Incomplete questionaire answers
Study of Talaporfin Sodium Photodynamic Therapy to Treat Advanced Age Related Macular Disease

The purpose of this study is to determine the safety and tolerability of Talaporfin Sodium (LS11) Photodynamic Therapy in patients with late stage Age-Related Macular Disease (AMD).

This Phase 1 study is a safety and tolerability investigation of LS11 photodynamic therapy in subjects with persistent leaking neovascular membranes in patients with AMD who have a visual acuity of 20/200 or less. This is a sequential group dose escalation trial with the cohorts defined by increasing the light dose. Within each light-dose cohort, three (3) subjects will be treated at a drug dose of 0.2 mg/kg or 0.5 mg/kg.

Eligibility Criteria:
Inclusion Criteria:

* Age 50 or older
* Subject is able to sign informed consent
* Ability to complete 6 month trial
* Present with advanced AMD and persistently leaking CNV
* Adequate hematologic, renal and liver function
* Negative pregnancy test
* Subject is able to safely undertake all protocol directed instructions
* Visual acuity of 20/200 (logMAR 1.0)(6/60) or worse

Exclusion Criteria:

* Concomitant eye disease in eye to be treated
* Prior ocular radionuclide treatments
* Known allergic or hypersensitivity reactions to light and/or fluorescein and iodine or shellfish
* History of investigational drug or therapy including biologics within 30 days prior to the study drug dosing
* Women who are pregnant or lactating, or women of childbearing years not taking adequate contraception precautions
* History of porphyria, systemic lupus erythematosus, or xeroderma pigmentosum
* History of clinically significant cardiovascular abnormalities, including myocardial infarction in the past 6 months, uncontrolled arrhythmias, uncontrolled congestive heart failure
* Concomitant use of other drugs known to produce skin photosensitivity, e.g. tetracycline, sulfonamides, phenothiazines, sulfonylureas, thiazide diuretics and griseofulvin, St. John's Wort
* Subjects with high or pathological myopia with an axial length \> 26mm or a refractive error of \>/= -8.00D
* Subjects with glaucoma and vision loss in either eye
* Subject with a history of other choroidal leakage, e.g. histoplasmosis
* Subjects with significant media opacity
* Subjects diagnosed with diabetic retinopathy
* Subjects who have had eye surgery within the past 3 months
* Subjects who have received PDT treatment for AMD in the treatment eye
* Any disease or condition that the sponsor or the investigator believes will impact the subject's ability to adhere to the study schedule
* Subjects participating in any concurrent trial
Transcatheter Arterial Micro-Embolization (TAME) Using Nexsphere-F in Patients With Chronic Pain in Elbow or Wrist

In patients with chronic elbow or wrist pain, the pain is controlled by conventional conservative therapy The pain reduction effect of Nexsphere-F embolization in patients who need additional treatment It is intended to demonstrate safety.

This clinical trial is a single cancer, single center, open label, and pilot clinical trial that demonstrates the performance and safety of Nexsphere-F for patients aged 19 to 80 who need additional treatment because their pain is not controlled even after taking existing treatments.

In addition, through this clinical trial, complications of embolization and Nexsphere-F and It checks the safety of side effects. Therefore, in this study, TAME treatment for patients with chronic elbow pain 2 to 7 months, 1 month later, 3 months, 6 wah VAS score reductions and QuickDASH scores, PRTEE score primary 6 Evaluate the reduction rate of medication, discontinuation rate of combination therapy, and occurrence of abnormal cases during the follow-up period. For patients with chronic wrist pain, VAS score after 2 to 7 days, 1 month, 3 months, and 6 months of TAME treatment QuickDASH score reduction rate, drug reduction rate after 6 months, discontinuation rate of combination therapy, and follow-up period the investigators will evaluate the effectiveness and safety of Nexsphere-F by evaluating whether abnormal cases occur during the period.

Eligibility Criteria:
Inclusion Criteria:

1. Those aged 19 to 80
2. Anyone who can provide a consent form
3. A person with a life expectancy of at least 12 months
4. Those who have not responded or failed in preservation treatment for at least three months(e.g. NSAIDS/physical therapy/steroidal joint injections, etc.)
5. VAS score of 4 or higher and moderate-severe elbow or wrist pain

Exclusion Criteria:

1. Those with a VAS Score of less than 4 and Mild Elbow or Wrist Pain
2. Chronic Renal Insufficiency(Serum creatinine \> 2mg/dL)
3. allergy to iodide contrast agents that do not respond to steroids
4. Those with acute infection or malignancy
5. Those who have previously had elbow or wrist surgery
6. Those with Bleeding Diabetes that cannot be calibrated
Study of M5049 in CLE and SLE Participants

This study is to evaluate the safety, tolerability and pharmacokinetics (PK) of orally administered M5049 in participants with systemic lupus erythematosus (SLE) or cutaneous lupus erythematosus (CLE).


Eligibility Criteria:
Inclusion Criteria:

* Active systemic lupus erythematosus (SLE) with a Cutaneous lupus erythematosus disease area and activity index (CLASI-A) greater than or equal to \[\>= \] 6 and/or at least one active SLE clinical manifestation according to Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K)
* Active cutaneous lupus erythematosus (CLE) (subacute cutaneous lupus erythematosus and/or discoid lupus erythematosus) with a CLASI-A \>= 6
* Other protocol defined inclusion criteria could apply

Exclusion Criteria:

* Autoimmune or rheumatic disease other than SLE or CLE
* Dermatological diseases other than cutaneous manifestations of SLE or CLE
* Uncontrolled medical conditions including significant cardiovascular events, active lupus nephritis, and active neurological disorder
* Ongoing or active clinically significant viral, bacterial or fungal infection
* History of uncontrolled seizures or other neurological disorder
* History of or positive for human immunodeficiency virus, hepatitis C virus, or hepatitis B virus
* History of malignancy
* Other protocol defined exclusion criteria could apply