cyrilzakka/clinical-trials huggingface dataset:
Pilates Exercises in Patients with Inhalation Injury

Inhalation injury is a composite of multiple insults including: supraglottic thermal injury, subglottic airway and alveolar poisoning, and systemic poisoning from absorbed small molecule toxins. These contaminant insults independently affect each of the pulmonary functions as well as having a direct effect on systemic physiology. Further, anatomic characteristics can predispose patients to inhalation injury. For example, an infant will develop airway obstructions much faster than an adult due to reduced airway diameter. Understanding the contributions of each of these pathologies to the patient's disease is critical to managing inhalation injury.

Extra lung mucus secretions, injured mucosa, contaminants, and aspirated substances should be handled in their early stages. In the case of fibrinous material transudates, compromised mucociliary secretions and mucosal slough must be cleared. There are different methods to assist the clearance of secretions as bronchoscopy, ventilator, mucolytics, suction, and chest physiotherapy.

In Pilates method (PM), several muscles are activated, including the muscles involved in breathing, especially to improve the expiratory function, which remains contracted during the inspiratory and expiratory phase. Breathing control is fundamental during the execution of PM exercises, where the practitioner learns how to breathe properly as an essential part of each exercise through forceful exhaling followed by complete inhaling. Thus, adequate breathing aids in controlling movements, and therefore, the method can be regarded as an indirect strategy for respiratory muscle training. It is known that poor control of breathing can result in compensation and lung volumes and respiratory muscle performance, with several factors involved.

Eligibility Criteria:
Inclusion Criteria:

1. Patients in both sexes and their age will range from 20-50 years.
2. Six weeks after deep second-degree thermal burn with inhalation injury (until complete healing) with 35%-40% total body surface area (TBSA).
3. Patients suffering from retained secretions which did not respond to medical treatment. (4) All patients should be clinically and medically stable.

(5) All patients should have the same medical treatment.

Exclusion Criteria:

1. Participants with a history of regular physical activity (regular exercise habit \> 3 times/ week or \>150 min/ week) in the last 6 months.
2. Participants with less than an 85% attendance rate at the sessions.
3. Participants with any dysfunction that limit physical activity such as neurological disorders, chronic obstructive pulmonary disease, uncontrolled hypertension, malignancy, cardiovascular diseases, deep vein thrombosis, rheumatoid arthritis, orthopedic problems, such as fracture on the pelvic or limbs, a visual impairment, or hearing impairments and contractures.
4. Smokers.
5. Pregnant females.
6. Obese participants (BMI \> 30 kg/m2).
7. Participants use non-invasive mechanical ventilation and intubation or need for intensive clinical support and/or transfer to the Intensive Care Unit.
Evaluation of Fructose Ingestion and the Renin Angiotensin System in Humans

Fructose is an ingredient that is added to many of our foods. It is a cheaper, sweeter additive that can be found in everything from soda pop to yogurt to granola bars. In the last few years a significant number of studies have been published linking consumption of fructose with obesity, hypertension and more recently, kidney and cardiovascular disease.

Animal studies show a strong link between excessive ingestion of fructose and the development of kidney and cardiovascular disease mediated by the renin angiotensin system, a hormonal system whose activation is detrimental to both the kidney and the heart. There has been very little research done on the potentially pathophysiological relationship between a high fructose diet and kidney and cardiovascular disease in humans.

The investigators hypothesize that ingestion of fructose will result in upregulation of the renin angiotensin system in humans.

Cardiovascular disease in women is a significant risk factor. By having women participate who are on the birth control pill and as well as women who use non oral forms of birth control or no birth control, kidney function and cardiovascular health can be examined as it relates to in the influence oral hormones might play. How the kidney responds to the influence of sugar and fructose while a woman is on an oral birth control pill, may reveal mechanisms that could help us understand cardiovascular disease in women.

PRIMARY AIM: To examine whether the physiologic and molecular responses to Angiotensin II (AngII) challenge differ in response to fructose intake as assessed by two independent means:

1. The renal and mean arterial pressure (MAP) response to an AngII challenge.
2. Reactive changes in circulating levels of renin and aldosterone with graded AngII challenge.

PRIMARY HYPOTHESES: Ingestion of fructose in healthy subjects will result in:

1. A decrease in renal and systemic sensitivity to infused AngII.
2. A decrease in the reactive changes in renin and aldosterone with graded AngII challenge.

Eligibility Criteria:
Inclusion Criteria:

* age≥18 years,
* able to comprehend study and comply with high-salt diet
* kidney disease (on the approval of their nephrologist)
* on an oral birth control pill and non oral birth control and those not on birth control

Exclusion Criteria:

* cardiovascular disease (symptoms consistent with myocardial ischemia, previously documented myocardial ischemia, cardiac arrhythmias or valve abnormalities, or abnormal ECG at screening)
* cerebrovascular disease (transient ischemic attacks or stroke)
* hypertension (BP\>140/90 or use of antihypertensive medications)
* diabetes mellitus (defined by history, use of hypoglycemic agents or a fasting glucose \>7mmol/L)
* hyperlipidemia (LDL \>4.5mmol/L or use of lipid-lowering agents)
* pregnancy
Implementing Music Therapy for Video-Assisted Thoracoscopic Surgery Patients: A Quality Improvement Initiative

The purpose of this project is to introduce and implement music therapy as an evidence-based pain management protocol focused on reducing postoperative pain levels among Video-Assisted Thoracoscopic Surgery (VATS) patients in the Post-Anesthesia Care Unit (PACU) of the project site. The clinical question guiding this initiative is: In adult patients undergoing a VATS procedure, does the implementation of music therapy lead to lower postoperative pain scores in the PACU compared to no intervention within an 8-week timeframe? The investigator will ask eligible patients their immediate pain scores upon arrival into the PACU and then start music of patient's choice via over-the-ear headphones. Pain scores will be rechecked 30 minutes after implementation of music therapy. The standard of care pain medications and/or usual care will not be withheld or altered after surgery in lieu of music therapy.

The clinical question guiding this initiative is: In adult patients undergoing a VATS procedure, does the implementation of music therapy lead to lower postoperative pain scores in the PACU compared to no intervention within an 8-week timeframe? The investigator will ask eligible patients their immediate pain scores upon arrival into the PACU and then start music of patient's choice via over-the-ear headphones. Pain scores will be rechecked 30 minutes after implementation of music therapy. The standard of care pain medications and/or usual care will not be withheld or altered after surgery in lieu of music therapy.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18 years and older with lung mass diagnosis undergoing VATS

Exclusion Criteria:

* Individuals with dementia, neurocognitive disorders, or chronic pain conditions.
Effect of omega3 on Congestive Heart Failure

In this double blinded study patients with resynchronization pacemaker- AICD were assigned to Omega3 and placebo randomly, results indicated that Omega3 had no more effect than placebo in mortality, BNP level and 6 minutes walk test.

Introduction: Widely used as lipid lowering agents, Omega 3 fatty acids have been demonstrated to possess the potential to reduce the risk of cardiovascular events in patients suffering from chronic heart conditions. In this double -blinded randomized placebo-controlled clinical trial, we aim to investigate the possible beneficial effects of Omega-3 supplements on echocardiographic parameters and brain natriuretic peptide (BNP) plasma levels in patients suffering from congestive heart failure (CHF).

Methods and Materials: 100 patients with class II and III CHF, who had tri-chamber pacemaker and automated defibrillator( CRT-AICD) were initially recruited among which 70 subjects consented to participate. Subjects were randomly assigned and matched to two treatment groups. 42 patients were allocated to a two gram/day dosing of omega-3 capsule while 28 subjects were allocated to the placebo group. Demographic features and BNP plasma levels, 6-minute walk test and echocardiographic parameters of patients were recorded at baseline and at 6 months after implementation of treatment protocols. Data were further gathered and analyzed to evaluate the beneficial effects of omega-3 supplements compared to placebo.

Conclusion: Beneficial effects of Omega-3 supplementation on CHF patients were not as dramatic as initially presumed

Eligibility Criteria:
Inclusion Criteria:

* EF\< 40%
* sinus rhythm
* accept randomization

  * having tri-chamber pacemaker

Exclusion criteria:

* survival less than 6 months
* class IV heart failure
* using drugs other than study protocol
(S5-SAMU) Randomized Study Comparing the ASV (Adaptative Support Ventilation) to Conventional Ventilation

Compare ventilation parameters in Adaptative Support Ventilation mode to conventional mode, on intubated, ventilated and sedated patients, during their secondary transfer from an hospital to another, by a SMUR team.


Eligibility Criteria:
Inclusion Criteria:

* Intubation
* Secondary transfer (interhospital)
* Informed patients / close relations, signed consent

Exclusion Criteria:

* Primary transport of a ventilated, intubated, sedated patient
* Patient in limitation and stop of active therapeutics, dying person
* Broncho pleural fistula
* Patient under ECMO
* Patient included in another research submitted to consent
* Supervision, loss of liberty
* Pregnant woman
Mechanism of Action of Milk and Its Components on Glycemic Control in Healthy Young Men

The investigators hypothesize that the physiological effects of milk on satiety and glycemic control are mediated by the interaction between its macronutrient components by both insulin-dependent and independent mechanisms.


Eligibility Criteria:
Inclusion Criteria:

* Healthy young men
* 20-30 years of age
* BMI: 20-24.9 kg/m2

Exclusion Criteria:

* Smoking
* Dieting
* Skipping breakfast
* Lactose intolerance or allergies to milk
* Taking medications that may affect glucose metabolism or appetite
* Diabetes (fasting blood glucose ≥ 7.0 mmol/L) or other metabolic diseases
Radicle Clarity: A Study of Health and Wellness Products on Mental Clarity and Health Outcomes

A randomized, blinded, placebo-controlled direct-to-consumer study of health and wellness products on mental clarity and other health outcomes

This is a randomized, blinded, placebo-controlled study conducted with adult participants, age 21 and older and residing in the United States.

Eligible participants will (1) endorse a desire for better concentration, (2) indicate an interest in taking a health and wellness product to potentially help their concentration, and (3) express acceptance in taking a product and not knowing its formulation until the end of the study.

Participants with known liver or kidney disease, heavy drinkers, and those who report they are pregnant, trying to become pregnant, or breastfeeding will be excluded. Those taking certain medications will be excluded.

Self-reported data are collected electronically from eligible participants over 7 weeks. Participant reports of health indicators will be collected during baseline, throughout the active period of study product use, and in a final survey. All study assessments will be electronic; there are no in-person visits or assessments for this real-world evidence study.

Eligibility Criteria:
Inclusion Criteria:

* Adults, 21 years of age and older at the time of electronic consent, inclusive of all ethnicities, races, genders and/or gender identities
* Resides in the United States
* Endorses better concentration as a primary desire
* Selects concentration and/or looking to improve their concentration as a reason for their interest in taking a health and wellness product
* Expresses a willingness to take a study product and not know the product identity (active or placebo) until the end of the study

Exclusion Criteria:

* Reports being pregnant, trying to become pregnant, or breastfeeding
* Unable to provide a valid US shipping address and mobile phone number
* The calculated validated health survey (PRO) score during enrollment represents less than mild impairment or severity
* Reports a diagnosis of liver or kidney disease
* Reports being a heavy drinker (defined as drinking 3 or more alcoholic beverages per day)
* Unable to read and understand English
* Reports current enrollment in a clinical trial
* Lack of reliable daily access to the internet
* Reports current or recent (within 3 months) use of chemotherapy or immunotherapy
* Reports taking medications with a known moderate or severe interaction with any of the active ingredients studied or a substantial safety risk: Anticoagulants, a medication that warns against grapefruit consumption, corticosteroids at doses greater than 5 mgs per day, oral anti-infectives (antibiotics, antifungals, antivirals) to treat an acute infection, antipsychotics, or MAOIs (monoamine oxidase inhibitors)
* Reports a diagnosis of heart disease when a known contraindication exists for any of the active ingredients studied: NYHA (New York Heart Association) Class III or IV congestive heart failure, Atrial fibrillation, Uncontrolled arrhythmias
Safety and Tolerability of MRZ-99030 Eye Drops in Healthy Volunteers and Glaucoma Patients

* To assess the safety and tolerability of repeat dose topical administration of MRZ-99030 Ophthalmic Solution with ascending doses in healthy subjects (stage 1) and glaucoma subjects (stage 2).
* To assess plasma pharmacokinetics and urine concentration of MRZ- 99030 and its metabolite MRZ-9499 after single and repeat dose topical administration of MRZ-99030 Ophthalmic Solution.


Eligibility Criteria:
Inclusion Criteria:

For stage 1:

- Healthy volunteers

For stage 2:

- Glaucoma patients

Exclusion Criteria:

For stage 2:

- Any relevant eye disease other than glaucoma
Effect of Endodontic Treatment on Inflammatory Markers, Disease Activity and Periapical Healing in Rheumatoid Arthritis Patients With Apical Periodontitis : A Prospective Interventional Study

SUMMARY TITLE: "Effect of endodontic treatment on inflammatory markers, disease activity and periapical healing in rheumatoid arthritis patients with apical periodontitis"

RATIONALE: Chronic inflammation plays a pivotal role in rheumatoid arthritis as subjects present with elevated serum levels of numerous cytokines such as IL-1, IL-6, 1L-12, IL-17, tumour necrosis factor-alpha, RANK and RANK Ligand. Periodontal and pulpal inflammation are two major low grade chronic inflammatory diseases of the oral cavity. Apical periodontitis extends from the chronic inflammatory process that originated in the dental pulp to surround the apex of the tooth. Thus Rheumatoid arthritis and apical periodontitis converge upon common pathway of inflammation. The scientific literature has also shown to provide potential link between endodontic infection and rheumatoid arthritis. The evidence of increased prevalence of apical periodontitis in subjects of rheumatoid arthritis is provided mainly by cross-sectional and case control studies. Interventional studies have been performed in subjects with rheumatoid arthritis and periodontal disease, with results depicting beneficial effect of periodontal therapy in patients of rheumatoid arthritis. To best of our knowledge no interventional study has been performed to assess the healing pattern of apical periodontitis in subjects of rheumatoid arthritis and subsequently effect of endodontic intervention on inflammatory profile and disease burden in the same.


Eligibility Criteria:
Inclusion Criteria:

* 1. Age of patients 30-65 years 2.Definite diagnosis of Rheumatoid arthritis based on ACR/EULAR 2010 criteria\[28\] i.e a score of 6 or greater out of 10 from the individual scores in four domains: number and site of involved joints (range 0-5), serological abnormality (range 0-3), elevated acute-phase response (range 0-1) and symptom duration (two levels; range 0-1) 3. The periapical index (PAI) will be used to evaluate the periapical status patients with PAI \>or=3 as given by Orstavik\[29\] will be included 4. Presence of total teeth \>/= 12

Exclusion Criteria:

1. Patients with periodontitis, pocket depth and CAL\>5mm (stage 3, 4) will be excluded.
2. Pregnancy; lactation \& contraceptives
3. Patients with any other systemic disease other than Rheumatoid arthritis i.e Diabetes, HIV, Chronic Liver Disease, Chronic Kidney disease and Cardiovascular disease

5. Conditions known to alter systemic inflammatory markers i.e orthopaedic trauma, surgery and viral infections 6. Patients with BMI \>/= 30 7. Medications (during last 3 months) known to affect systemic inflammatory markers (systemic steroids, immunosuppressants, hormone replacement therapy, contraceptives and systemic antibiotics) 8. Smoking

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Forced Oscillations for Diagnosis Help in Bronchiolitis Obliterans Syndrome in Post Bone Marrow Transplantation

A study to evaluate the role of forced oscillations in diagnosis of bronchiolitis obliterans syndrome in patients after bone marrow transplantation. The force oscillations technique will be compared with classical spirometry.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years
* Bone marrow or hematopoietic stem cells transplantation for more than 100 days
* Clinical stability
* Patients affiliated to a social security system
* Patients having given his (her) written consent.

Exclusion Criteria:

* Bronchiolitis Obliterans already diagnosed
* Unresolved Respiratory infection
* Unresolved mechanical complication (pneumothorax, effusions)
* Medicinal pneumopathy
* Inability to perform pulmonary function tests
Spiriva® in Patients With Chronic Obstructive Pulmonary Disease (COPD) in Daily Practice

Post-marketing surveillance to gather information regarding the tolerance and efficacy of Spiriva® 18 micrograms in patients with COPD under conditions of daily practice.


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged at least 40 years with the symptoms of Chronic Obstructive Pulmonary Disease

Exclusion Criteria:

* Patients with the general and specific contraindications listed in the Patient Information Leaflet and the Basic Product Information
CapFlex PIP Implant RSA

Rationale: Patients with osteoarthrtis (OA) of the proximal interphalangeal (PIP) joint are commonly treated with joint arthroplasty. The CapFlex PIP implant is a modular surface replacing implant, which has good short-term functional results with a relatively low complication rate. To reduce implant failure and to increase long-term survival, it is important to expand knowledge about fixation and loosening patterns. By using model-based roentgen stereogrammaetric analysis (mRSA), the migration pattern of the implant over time can be calculated.

Objective: The primary objective is to assess the fixation and migration patterns of the CapFlex PIP implant system (produced and developed by several companies of KLS Martin Group) in vivo, using mRSA, over 10 years. Secondary objectives are to analyse survival, clinical scores and radiographic aspects of the CapFlex PIP implant system.

Study design: A prospective cohort study with 10 years follow-up, in which 36 patients will be enrolled. Patients will be evaluated preoperatively, at 6 weeks, 6 months, 1 year, 2 years 5 years and 10 years.

Study population: Patients 18 years or older who require a proximal interphalangeal joint arthroplasty as a result of osteoarthritis of a proximal interphalangeal joint.

Main study parameters/endpoints: The main study parameters are the migration of the CapFlex PIP implant system of the distal as well as the proximal component (presented in x-, y- and z-direction). Secondary study parameters are the survival of the CapFlex PIP implant system, clinical scores and radiographic aspects.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Patients participating in the study will have the same risks when not participating in the study. Patients are asked to spend time to fill in the questionnaires and to have 3 extra visits to the hospital, next to the standard visits. Patients will have more follow up visits and will be followed using RSA analysis, which has as advantage that possible complications might be noticed earlier compared to normal follow up.


Eligibility Criteria:
Inclusion Criteria:

* Indication for PIP joint arthroplasty as described in the manufacturer's guideline, namely as a result of:

  * Painful osteoarthritis
  * Instable communitive intra-articular PIP fractures
* Age \> 18 years
* Patient is able to speak and write Dutch
* Patient is willing to participate
* Patient is able and willing to provide written informed consent

Exclusion Criteria:

* Inflammatory arthritis with significant bone loss
* Insufficient bone quality to provide adequate stability
* Known or suspected sensitivity or allergy to one or more of the implant materials
* Revision surgery
* Significant collateral instability
* Pregnancy or breastfeeding
BRInging the Diabetes Prevention Program to GEriatric Populations - PILOT

The purpose of this pilot study is to test the feasibility of implementing a telehealth adaption of the Diabetes Prevention Program (DPP) intervention among 30 NYC senior center members. The intervention will be conducted through 6 weekly webinars with a certified DPP coach. Participants will receive a binder and physical activity tracker to complete self-monitoring of diet and physical activity. The primary outcome is feasibility and acceptability of the intervention measured by workshop attendance and focus group feedback. Secondary outcomes include changes in diet, physical activity, and weight.


Eligibility Criteria:
Inclusion Criteria:

* Men and women age ≥ 60 years
* Diabetes Risk Score \>=5

Exclusion Criteria:

* Decisional incapacity to consent