cyrilzakka/clinical-trials huggingface dataset:
Cardiopulmonary Fitness in Long-Term Survivors of HPV-related Oropharynx Cancers

This study is being done to learn about how the participants lungs and heart are working after treatment for throat cancer. The investigators are looking to see if there is a long-term impact on overall health from the cancer treatment. The long-term goal of this study is to compare the participants overall quality of life to similarly aged people who have not had throat cancer.

The goal of this study is not to test the impact of a specific intervention, but rather to evaluate the long-term cardiovascular health and quality of life of oropharyngeal cancer survivors using validated survey instruments, cardiopulmonary testing, and measurements of cardiac risk factors. Thus, no intervention, other than the assessments will be administered as part of the protocol. All participants will have received treatment according to the standard of care or a therapeutic clinical trial in which they may have participated previously. We will collect information about prior treatment from the electronic medical record (EMR).

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Diagnosis of HPV+ squamous cell carcinoma of the oropharynx confirmed by the pathology department of MSKCC. Positive HPV status defined as chromogenic in situ hybridization with wide spectrum HPV probe (HPV III family 16 probe (Ventana) with affinity to HPV genotypes 16, 18, 31, 33, 35, 45, 51, 52, 56, 58, and
* 66) or p16 immunohistochemistry done in a Clinically Laboratory Improvement Amendment (CLIA) approved laboratory; if either of these 2 tests are positive, the patient is classified as HPV positive\]
* Completed last treatment for oropharyngeal cancer (surgery, chemotherapy, or radiation) at least 3 years before enrollment in study
* Able to speak and read English
* Clinically shows no evidence of disease (NED)
* Received radiation therapy with a dose of at least 60Gy, at MSKCC as part of concurrent treatment
* Medical clearance from a member of the patient's healthcare team indicating no relative contraindications to undergoing a cardiopulmonary exercise test

Exclusion Criteria:

* Diagnosis with recurrent disease following completion of primary curative treatment
* History of any cancer other than HPV+ oropharyngeal squamous cell carcinoma, or current diagnosis of another cancer
* Current diagnosis of any of the following: Acute myocardial Infarction (within 3-5 days of any planned study procedures); Unstable angina; Arrhythmia; Syncope; Active endocarditis; Acute myocarditis or pericarditis; Symptomatic severe aortic stenosis; Heart failure; Acute pulmonary embolus or pulmonary infarction; Thrombosis of lower extremities; Suspected dissecting aneurysm; Pulmonary edema; Room air desaturation at rest ≤85%; Respiratory failure; Any acute non-cardiopulmonary disorders that may affect exercise performance or be aggravated by exercise (i.e., infection, renal failure, thyrotoxicosis); COPD or asthma noted in patients EMR.
* Mental impairment leading to an inability to cooperate or consent to this research study
Investigation of the Effects of Aerobic Exercise, Balance Exercise and Combined Exercise Practices on Frailty, Balance, Fall Risk, Reaction Time, Cognitive Functions and Quality of Life in Dementia Patients

Dementia is a clinical disorder characterized by progressive and permanent loss of multiple cognitive functions, especially memory, at a level that affects activities of daily living. There is no pharmacologic treatment method that can change the prognosis in dementia. The methods used today are symptomatic and cause various side effects. For this reason, non-pharmacologic approaches are on the agenda in the treatment of dementia. Among these approaches, physical activity approaches such as symptomatic treatment or exercise come to the forefront due to their prognosis-slowing effects. There are also many studies showing that dementia is directly related to physical performance and frailty. Deterioration of physical performance, increased frailty, and decreased muscle strength create a vicious circle with the prognosis of dementia. In addition, patients with dementia have balance problems due to prolonged reaction time, cognitive impairment and physical problems, and the risk of falls increases. In order to prevent the risk of falls, exercise practices are of great importance. Although the effects of aerobic exercise on dementia have been examined many times in the literature, there are very few studies examining the effects of balance exercises and combined exercises. In addition, physical characteristics such as frailty and muscle weakness, which are very common in patients with dementia, have not been evaluated as a whole in studies on patients with dementia. Therefore, this study will be conducted to comparatively examine the effects of combined aerobic exercise and balance exercises on balance and falls, frailty, muscle strength, cognitive functions, and reaction time in patients with dementia.


Eligibility Criteria:
Inclusion Criteria:

* Age over 65 years,
* To be able to speak and understand Turkish,
* To have at least primary education,
* Perceive and adapt to simple commands,
* Scoring between 18-23 on the standardized mini mental state assessment scale (200),
* To be able to provide independent mobilization,
* Volunteering to participate.

Exclusion Criteria:

* Rapid progression of dementia (infectious, vascular, hematologic diseases),
* Cardiac or cerebrovascular event, endocrine disorder, fluid-electrolyte imbalance or infection during the follow-up period,
* Presence of malignancy,
* Detection of a delirium picture,
* Presence of severe depression,
* Participate in a regular exercise program for at least 6 months before the study,
* Having a fracture or fracture surgery in the lower extremity within the last year,
* Any orthopedic problem that prevents him/her from exercising.
Pilot Study for Healing and Safety Outcomes in Gingival Recession

Prospective, randomized, within subjects-controlled design

The objective of this trial is to evaluate clinical healing outcomes of microsurfaced cadaveric ADM (Markman Biologics) used in sites with \< 1 mm of attached gingiva requiring soft tissue grafting without root coverage as compared to control cadaveric ADM (AlloDerm, LifeCell) over 180-day post-op period. During the treatment period, each site will be monitored for soft tissue healing and augmentation of keratinized tissue width. All subjects will be seen at post-op day 7, 14, 30, 90, and 180.

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent by patient or Legally Authorized Representative (LAR)
2. Patients with ≥2 non-adjacent teeth in the same jaw presenting with ≤ 1mm attached gingiva that requires soft tissue grafting without the need for root coverage
3. Patients with good oral hygiene as indicated by presence of minimal plaque and absence of material alba and calculus.
4. ≥ 18 and ≤ 75 years of age
5. Sexually active subjects (both men and women) who agree to use acceptable contraceptive methods for the duration of the study.

Exclusion Criteria:

1. Vestibule depth \<7mm from the base of recession
2. Systemic condition, such as uncontrolled diabetes mellitus, HIV, cancer, or bone metabolic disease that could compromise wound healing
3. Treatment with systemic corticosteroids, immunosuppressive agents, radiation therapy, or chemotherapy within 2 months of enrollment in the study
4. Acute infection lesions in intended grafting sites
5. Received intravenous or intramuscular bisphosphonates
6. Tobacco use within 3 months of enrollment or for the duration of the study
7. Only molar teeth suitable for soft tissue grafting (molars may be treated but not assigned as the study tooth)
8. Miller grade ≥2 mobility on grafting sites or adjacent teeth
9. Known hypersensitivity to bovine collagen or iodine (shellfish allergy)
10. Previous treatment with an advanced biologic at sites selected fro grafting or the adjacent teeth
11. Pregnant or nursing female subjects; women of child-bearing potential must have a negative urine pregnancy test.
12. Developmental disability/significant psychological disorder that in the opinion of the investigator could impair the subject's ability to provide informed consent, participate in the study protocol or record study measures, including untreated schizophrenia, bipolar disorder and psychiatric hospitalization within the last 2 years.
13. Active alcohol or substance abuse (including marijuana, THC, CBD oils and products) in the opinion of the investigator that could impair the subject's participation in the study.
14. Any medical condition or co-morbidity that in the opinion of the investigator, would prevent successful participation in the study
15. Known allergies to Cefoxitin, Gentamycin, Lincomycin, Polymyxin B, Vancomycin, or any antibiotic in these same classes.
16. Known allergy to Polysorbate 20
A Study Protocol for the Validation of UAud in a Clinical Setting.

The objective of this study is to validate the User-operated Audiometry (UAud) system for user-operated audiometry in a clinical setting, by investigating if hearing rehabilitation based on UAud is non-inferior to hearing rehabilitation based on traditional audiometry, and whether thresholds obtained with the user-operated version of the Audible Contrast Threshold (ACT) test correlates to traditional measures of speech intelligibility.

The project will focus on the initial examination of patients who are referred for hearing aid treatment. This initial examination consists of an audiometry which is currently conducted manually by an audiologist. However, it is possible to conduct an audiometry as a user-operated self-test by using a computer. The project will test if hearing rehabilitation based on the user-operated audiometry is non-inferior to hearing rehabilitation based on the gold standard of manual audiometry. The project will use several types of patient reported measures as well as objective measurements in the clinic. Research of this type is needed to understand if the quality of the hearing aid treatment is equal no matter the type of examination.

Also, the study will investigate whether thresholds obtained with the user-operated version of the Audible Contrast Threshold (ACT) test correlates to traditional measures of speech intelligibility.

Eligibility Criteria:
Inclusion criteria

* Sensorineural hearing loss with hearing thresholds exceeding 20 dB HL at two or more frequencies in the frequency range of 0.5 to 4 kHz.
* Symmetric hearing loss with a maximum pure-tone average (PTA) (mean of 0.5-1-2-4 kHz) difference between the ears of 15 dB HL.
* Danish native speaker.
* No previous experience with HAs.
* Capable of answering questionnaires through an online mailbox.

Exclusion criteria

* Air-conduction audiometry thresholds exceeding 80 dB HL at two or more frequencies.
* Treatment affected by conductive hearing loss (air-bone gap \>10 dB on more than one frequency below 1 kHz).
* Conditions with fluctuating hearing loss, e.g., Menière's, on-going treatment with ototoxic drugs.
* Ear, nose, or throat surgery in the past 12 months.
* Evidence that the participant has made minor use of the HAs during the study (e.g., \< 2h per day).
* Visual or motor impairment that might affect the use of the UAud system.
Magnesium Sulfate on Postoperative Pain

Breast cancer is the most diagnosed type of cancer in women in Turkey and in the world. According to the World Health Organization data, the rate of newly diagnosed breast cancer was reported as 11.6% in 20181. Acute postoperative pain occurs in 40% of patients undergoing surgery for breast cancer2. In the early postoperative period, opioids are commonly used analgesics in the treatment of pain, but they have various side effects such as gastrointestinal, urinary and respiratory symptoms3. Non-opioid analgesics can be used to reduce opioid use and thus limit its side effects. Magnesium sulfate (MgSO4) is an N-Methyl D-Aspartate (NMDA) receptor antagonist that has been used for postoperative analgesia and reducing both the duration and intensity of pain by preventing central sensitization in response to peripheral painful stimulus4-9. The primary aim of this study is to investigate the postoperative analgesic efficacy of MgSO4 in patients who were scheduled for mastectomy with the diagnosis of breast cancer. The secondary aim of our study is to evaluate the changes in perioperative vital signs that may occur due to MgSO4.


Eligibility Criteria:
Inclusion Criteria:

1. Female breast cancer patients scheduled for mastectomy and modified radical mastectomy
2. 18≥ years and
3. Patients with ASA score I-II

Exclusion Criteria:

1. The patient who refused the study
2. Drug allergy
3. Unregulated diabetes mellitus and hypertension
4. Cardiac failure with \<45% ejection fraction
5. Renal failure (serum creatinine \> 2 mg/dL)
6. Liver failure (blood transaminase values 2 fold higher than normal)
7. Glaucoma
8. Psychiatric or neurological disorders
9. Communication difficulties with patient
10. Calcium channel blockers or narcotic drugs uses before surgery
The Santa Cruz Diabetic Retinopathy Utilizing Artificial Intelligence Study

In this clinical trial, we plan to evaluate the usefulness of artificial intelligence (AI) software paired with a handheld retinal camera to compare diabetic retinopathy status in Bolivian patients as read by retina specialists versus the AI software.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects who are at least 18 years old who have full legal capacity to volunteer on the date the informed consent is signed;
2. Subjects who can follow the instructions by the clinical staff at the clinical site, and can attend examinations on the scheduled examination dates;
3. Subjects who have been diagnosed with Type I or Type II diabetes mellitus.

Exclusion Criteria:

1. Subjects unable to tolerate ophthalmic imaging;
2. Subjects who have been scheduled for but have not yet undergone the following surgeries: Cataract Surgery (including any related follow-up procedures) or Vitrectomy.
3. Subject blind in one eye due to any cause
4. Subjects who have a condition or a situation, which in the investigator's opinion, may put the subject at increased risk, confound study data, or interfere significantly with the subject's study participation.
Effect of Antibiotic Rotation in the ICU on the Prevalence of Antibiotic Resistant Gram-negative Colonisation

The SATURN ICU-trial studies the effect of antibiotic rotation on the prevalence of antibiotic resistant Gram-negative colonisation.

Antibiotic rotation has been previously studied with varied results. The theory behind antibiotic rotation is that intermittently changing antibiotic classes will reduce the ecological selective pressure that drives the emergence of antibiotic resistance.

This study compares the effect of 2 types of antibiotic rotation on Gram-negative colonisation in the ICU and also compares both interventions with standard care.

The two interventions apply to the empiric treatment and are: 1) "fast" rotation, i.e. every other patient another class and 2) "slow" rotation, i.e. every other 1.5month another preferred class for empiric Gram-negative antibiotic therapy.

Eligibility Criteria:
Inclusion Criteria:

* There are at least 8 beds, with an average bed-occupancy of 80%; all of which have capacity for mechanical ventilation.
* The ICU can adhere to the selected antibiotics for empiric treatment of infections.
* There is an operational digital patient-information system, from which data can be extracted and delivered in a pre-defined format. Specifically an automated process for digital data-collection regarding microbiological culture-results (from swabs and bacteraemias), antibiotic prescription and patient demographics and illness severity-scores.
* Colonization with ESBL or resistance for any of the antibiotic groups is endemic, with proportions of ICU-acquired bacteraemias used as a proxy. Therefore, the investigators prefer proportions of AMRB infection in the period 2008-2009 to be: ESBL resistance among GNB 1 to 10% Piperacillin/Tazobactam among GNB 1 to10% Carbapenem resistance among Klebsiella Pneumoniae less than 5%
* Have the ability of at least one dedicated Infection Control HCW available for 0,2fte, for patient monitoring, compliance monitoring and instruction of HCWs regarding interventions. In the following this person will be called "Research-Nurse" or "RN".
* Can store screening-cultures at -70ºC
* Can facilitate transport through a UMCU courier.
* There is written approval for the study from the institution's IRB with a waiver for patient informed consent.
* A signature page is signed by the daily management of the candidate-ICU by both ICU physician and director and the ICU nursing-director and presented to the UMCU, indicating willingness to enroll the candidate-ICU in the study.

Exclusion Criteria:

ICUs planning to introduce, during the SATURN trial period, any major diagnostic- or intervention program that will affect AMRB ecology\*

* Burn units; due to the specific nature of the care provided and the patients admitted.
* Cardiothoracic surgery units; because of the expected small number of patients admitted for three days or more.
* Paediatric and neonatal ICUs.
Effects of Weight Loss on Nutritional Mediated Hormone Secretion

Investigative trial with aim of

1. the description of the hormonal and metabolic response to meals containing different compositions of macronutrients
2. the metabolic response to these test meals in dependance of the hepatic and muscular insulin sensitivity and abdominal adipose tissue and
3. effects of a weight loss on the hormonal response to these test meals containing different compositions of macronutrients

Primary endpoint:

Glucagon-like-peptide 1 (GLP-1), Glucose dependent insulinotropic peptide (GIP) and Ghrelin response to a nutritive stimulation characterized by different nutritional composition

Secondary endpoints:

* differences of substrate utilization depending on the nutritive composition
* effects of different hepatic and muscular insulin sensitivity as well as impact of visceral fat mass on the hormonal and metabolic response
* effect of weight loss on the hormonal and metabolic response to different test meals

Study procedure:

After primary characterization 50 probands (male and female) will receive 3 different test meals within a randomised (meal order) controlled trial.

The three different test meals differ in nutritional composition. During consumption of the test meal a characterization of the endogenous hormonal response and appetite behaviour is performed.

A nutritional counselling is performed according to the guidelines of the German Nutrition Society (DGE) to ensure a stable nutritive behaviour in the three days before the test meal administration.

After analysis of the hormonal response to these 3 different testmeals follows a weight reduction period over 3 months. Afterwards reevaluation of the probands (again administration of 3 different test meals over a period of 3 weeks) will be performed.

Principal aim of the study:

Gain of information leading to the understanding of the hormonal regulation of food intake. The individual variability shall be determined with the aim of an identification of patient groups which show various intensities of the responses to different macronutrients.


Eligibility Criteria:
Inclusion Criteria:

* BMI\>27 kg/m2
* given written informed consent

Exclusion Criteria:

* type 2 diabetes patients treated by insulin or drugs influencing incretin levels
* lack of health insurance
* weight changes \> 5 kg in the past 2 months
* pregnancy, breastfeeding
* patients with:

  * severe heart failure
  * impaired hepatic or renal function
  * disturbed coagulation (biopsies will not be taken in those subjects)
  * infection, malabsorption
  * severe hypertension
  * cancer within the last 5 years
  * eating disorders or any other psychiatric condition that would interact with the trial intervention
  * any other endocrine disorder
* changes of smoking habits or diets within the last 3 months prior to study inclusion \*other severe chronic diseases
Cognitive Rehabilitation for People With Cognitive Covid19

Cognitive impairment is increasingly recognised as a major component of long Covid, and is estimated to be present in 25-75% of affected individuals. This impairment impacts quality of life and the loss of functional ability has major consequences for affected people, their families and the wider economy given people's difficulty in returning to work.

This study will focus on helping people recover from cognitive Covid. This will involve use of rehabilitation strategies aimed at improving function in those cognitive functions identified in Stage 1 as being most affected, and assessing the benefit of rehabilitation on quality of life and people's ability to return to everyday function. These strategies will be co-produced in collaboration with a group of people living with cognitive Covid. At the end of Stage 2 we will produce a freely available "Covid-19 Cognitive Recovery Guide" for affected people, their close contacts and clinicians.

In conclusion, cognitive impairment is frequently observed in long Covid but at present little is understood about its nature, or how it can be treated. The sheer scale of the CV19 pandemic makes this a top priority unmet need for healthcare worldwide. The aim of this study is to meet this need and to deliver a treatment plan for affected people which will help them return to normal life and working ability.


Eligibility Criteria:
Inclusion Criteria:

1. Aged between 30 and 60 years
2. Evidence of prior CV19 infection:

   * either positive CV19 PCR
   * or positive CV19 antibody test
   * or acute symptoms consistent with the recognised core features of acute CV19 infection and post-acute symptoms consistent with the recognised core features of long Covid
3. Cognitive impairment persisting more than three months after the acute CV19 infection, defined in terms of subjective reports of cognitive decline post-infection

Exclusion Criteria:

1. Cognitive impairment prior to CV19 infection
2. Occurrence of acute neurological disorder, such as stroke or encephalitis, that could give rise to cognitive sequelae
3. People who are on any medications that are considered by the study investigators to have significant adverse effects on cognition
4. A pre-existing major psychiatric or medical disorder that is considered by the study investigators to have potential to affect cognition
5. High alcohol intake
6. Recreational drug use
7. Loss of mental capacity such that the affected individual is unable to give informed consent
8. Participants will not be eligible for Workstream 2 if they do not exhibit significant impairment on baseline cognitive assessments, as they will not gain from cognitive rehabilitation.
9. Participants with pacemakers or other implanted devices, those with metal foreign bodies (e.g. shrapnel from war injuries) and those who have had certain types of surgery will be excluded from the MRI substudy. Although MRI is not known to affect the unborn child, we will also exclude subjects who may be pregnant just to be on the safe side.