cyrilzakka/clinical-trials huggingface dataset:
Effect of Sugared Chewing Gum on Gastrointestinal Recovery After Major Colorectal Surgery

The Purpose of this study is to evaluate the effect of gum chewing on recovery of gastrointestinal function in patient undergoing major colorectal surgery. The investigators hypothesize that patients who chew gum after major colorectal surgery will have faster recovery of gastrointestinal function.


Eligibility Criteria:
Inclusion Criteria:

* Able to freely give written informed consent to participate in the study and have signed the Informed Consent Form
* American Society of Anesthesiologists (ASA) Class I-III (Appendix III);
* Due to undergo small and/or large partial bowel resection via laparotomy or laparoscopy

Exclusion Criteria:

* Mentally incompetent or unable or unwilling to provide informed consent or comply with study procedures
* American Society of Anesthesiologists (ASA) Class IV or V;
* History of abdominal carcinomatosis
* History of radiation enteritis
* Children \< 18 or adults \> 85 years of age
Open Label Immunotherapy of Endometriosis

Endometriosis is a chronic gynecological disease characterized by sustained painful symptoms that are responsible for a decline in the quality of life of sufferers. Endometriosis is fairly common, affecting an estimated 10%-15% of women and girls, usually during their reproductive years. Based on these rough estimates, the latest epidemiological studies suggest that over 200 million women are might be affected who may commonly have infertility problems. Additionally, endometriosis is a major factor increasing by 33-66% risk of ovarian cancer. V-Endo is a tableted preparation derived from hydrolyzed, heat-inactivated, pooled blood of women with endometriosis. When taken orally it is postulated to cause the immune tolerance and anti-inflammatory effect as a result.

Anatomically endometriosis is characterized by the presence of endometrial-type mucosa outside the uterine cavity. This tissue proliferates and causes chronic inflammation resulting in pain and excessive menstrual bleeding. Conventional treatment includes surgical and pharmacological therapy aiming at reducing painful symptoms. However, there is an unmet need in finding optimally safe and effective treatment. This study aimed to evaluate the effect of V-Endo on pain levels in women with endometriosis, focusing on reducing inflammation by immunotherapeutic intervention.

Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 50 years
* pain visual analog scale (VAS) score over 4 (visual linear scale from 0 to 10)
* confirmation of endometriosis by laparoscopy
* no drugs used at least for one month prior to enrollment, i.e., estro-progestinic, progestinic, gonadotropin-releasing hormone (GnRH) agonists and antagonists as well as nonsteroidal anti-inflammatory drugs (NSAIDs)

Exclusion Criteria:

* presence of other associated diseases such as malignancies
* concomitant use of hormonal drugs
* menopause
* pregnancy
* surgery for endometriosis within the last month prior to study entry
* unable or unwilling to give written consent patients
* adverse reaction or hypersensitivity to active substance or excipients of V-Endo
Phase 3 Study to Evaluate Safety and Efficacy of Iclaprim Versus Vancomycin for ABSSSI: REVIVE-2

This is a multicenter, randomized, double-blind study of the efficacy and safety of iclaprim compared to vancomycin for the treatment of skin and skin structure infections.

This is a multicenter, randomized, double-blind study of the efficacy and safety of IV iclaprim compared to IV vancomycin. Patients will receive either iclaprim or vancomycin for 5 to 14 days. Patients will be evaluated daily up to early time point (ETP), then every 48 to 72 hours through the end of treatment. Patients will also be evaluated at the test of cure (TOC) visit (7 to 14 days post-EOT), and will have a Late Follow-Up (LFU) visit (28 to 32 days post-first dose).

Eligibility Criteria:
Inclusion Criteria:

1. written informed consent;
2. ≥18 years of age;
3. a bacterial infection of the skin with a lesion size area of at least 75 cm2;
4. a major cutaneous abscess, cellulitis/erysipelas, and/or wound infections;
5. the presence of purulent or seropurulent drainage or at least three signs and symptoms of infection (discharge, erythema, swelling, warmth, or pain).

Exclusion Criteria:

1. severely impaired arterial blood supply such that amputation of the infected anatomical site is likely;
2. infected diabetic foot ulcers;
3. infected decubitus ulcers;
4. necrotizing fasciitis or gangrene;
5. uncomplicated skin or skin structure infection;
6. infections associated with a prosthetic device;
7. suspected or confirmed osteomyelitis;
8. conditions requiring systemic anti-microbial treatment, prophylaxis, or suppression therapy.
Multiple Chronic Conditions for Older Adults

Multiple chronic conditions are common and expensive among patients aged ≥65 and are associated with lower quality of life, poorer response to treatment, worse medical and psychiatric outcomes, higher mortality, and higher costs of care.

The primary purpose of this study is to conduct a randomized clinical trial (RCT) to examine the effects of ElderTree --a web-based intervention--on health outcomes and healthcare use among older adults with several chronic health conditions, such as diabetes, high blood pressure, high cholesterol, COPD, BMI over 30, congestive heart failure, chronic kidney disease, arrhythmia/atrial fibrillation, chronic pain, arthritis.

The investigator's hypothesis is that patients assigned to TAU+ElderTree will have better quality of life and fewer primary care visits than those assigned to TAU+Internet.


Eligibility Criteria:
Inclusion Criteria:

1. are ≥65 years old
2. have been treated in the University of Wisconsin Health clinics for at least the previous 18 months with no plans to leave during the study period
3. have 3 or more of the following chronic conditions: hypertension, hyperlipidemia, diabetes, arthritis, BMI over 30, chronic kidney disease, congestive heart failure, arrhythmia/atrial fibrillation, pulmonary heart disease or pulmonary vascular disease, chronic pain, COPD
4. report no current psychotic disorder that would prevent participation
5. have no acute medical problem requiring immediate hospitalization
6. be able to read and sign the consent form in English
7. have no known terminal illness
8. be willing to share health-related study data and

   * Systolic and diastolic BP
   * Weight
   * BMI
   * HDL/LDL
   * HbA1C
   * pain score
   * lung function
   * health care utilization: number of ER visits, urgent care visits, primary care visits and specialty care visits
9. allow researchers to share information with their primary care physician
A Study of AMDX-2011P in Participants With Alzheimer's Disease

The purpose of this study is to assess safety, tolerability, plasma pharmacokinetics and biologic activity of a single intravenous dose of AMDX-2011P in participants with Alzheimer's Disease (AD).

This open-label, masked endpoint assessment study will evaluate the safety, tolerability, plasma pharmacokinetics (PK) and biological activity of an intravenous (IV) dose of AMDX-2011P in participants with AD. Assessments of retinal images will be conducted by central masked assessors.

Participants will be admitted to the study site where eye examination and retinal imaging will be conducted before administration of the study drug. AMDX-2011P will be administered through a single IV bolus injection followed by safety assessments, retinal imaging and PK blood collection.

Eligibility Criteria:
Inclusion Criteria:

1. Confirmed diagnosis of Alzheimer's Disease (AD) with documented positive amyloid beta signal via positron emission tomography (PET) brain scan
2. Must be willing to consent to genotyping for apolipoprotein E (APOE)
3. Ability to fixate and undergo retinal imaging of both eyes

Exclusion Criteria:

1. Presence of any underlying physical or psychological medical condition that, in the opinion of the investigator, would make it unlikely that the participant will complete the study per protocol
2. Diagnosis of glaucoma, or suspect of having glaucoma in either eye as determined by an ophthalmologist as a clinical investigator, based on results from the eye examination, visual field, and/or optical coherence tomography (OCT) results
3. Diagnosis of intermediate dry, wet/neovascular, or geographic atrophy forms of age-related macular degeneration (AMD) in either eye, OR as determined by an ophthalmologist as a clinical investigator, based on results from the eye examination and/or optical coherence tomography (OCT) results
4. Clinically significant laboratory abnormalities as assessed by the investigator
5. Prolonged QTcF (corrected QT interval by Fridericia method) (\>450 ms for males and \>470 ms for females), cardiac arrhythmia, or any clinically significant abnormality in the resting electrocardiogram (ECG), as judged by the investigator.
LDD in Treatment of Femoropopliteal ISR

This study will evaluate the effectiveness and safety of local drug delivery using TAPAS balloon catheter system in the treatment of femoropopliteal in-stent restenosis. Patients with femoropopliteal in-stent restenosis will randomly receive balloon dilation or balloon dilation plus local drug delivery using balloon catheter system. Their clinical outcomes (e.g. 12-month late lumen loss or late lumen loss at secondary intervention within 12 months, 6-month and 1-year patency rate of target vessel) in 1 year after the treatment will be compared.

Femoropopliteal occlusive disease is a common type of peripheral arterial disease. Endovascular treatment has been the first-line treatment of femoropopliteal occlusive disease. However, the in-stent re-stenosis has been a major limitation of well long-term patency after stent implantation. The chronic inflammation induced by stenting could be a main reason of restenosis. Then the concept "leave nothing behind" is proposed, and some novel treatment methods and devices are developed. Here, the investigators propose the hypothesis that using local drug delivery with TAPAS balloon system can relieve the inflammation induced by the stent implantation and balloon dilation. Therefore, 40 patients of femoropopliteal in-stent restenosis will be randomly allocated into the group "balloon dilation+local drug delivery with balloon system" or "balloon dilation only". The 1-year patency rate,12-month late lumen loss, incidence of complications, imaging parameters will be compared between two groups.

Eligibility Criteria:
Inclusion Criteria:

* have signed the informed consent
* age of 18-80 years old
* femoropopliteal artery disease (Rutherford 2-4)
* femoropopliteal in-stent restenosis (≥70%)
* length of lesion ≤ 20cm
* at least one infrapopliteal run-off vessel

Exclusion Criteria:

* serum Cr \> 150 umol/L
* patients with acute thrombosis
* stent fracture within femoropopliteal artery
* allergic to aspirin, heparin, clopidogrel, paclitaxel, contrast medium
* already recruited into other clinical trials that could influence the outcome of this study
* pregnancy and lactation
* relatively easy bleeding
* malignancy or irreversible organ failure
Continuous Connected Patient Care (CCPC), a Pilot Testing a Novel Device for Continuous Vitals Monitoring - Older Adults Department PHC

To confirm feasibility and accessibility of the CCPC Platform (Oxymotion, Bridge Health Solutions medication adherence software, CloudDX home kit) in two different environments - 1) hospital (Acute Care for Elderly Unit) and 2) at-home .


Eligibility Criteria:
Inclusion Criteria:

* Inpatients on the Acute care of the Elderly ward.

Exclusion Criteria:

* Lack of capacity to consent to the study including moderate-severe dementia or delirium
* Unable to use (or does not have a caregiver who can help put on) study monitoring device at home
* Unable to complete (or does not have a caregiver who can help complete) study questionnaires by electronic (mobile, tablet, or computer), paper, nor phone
* Patient with known allergic reactions to any part material of the device
* People under 40kg
Trial of Internet-Based Cognitive Behavioral Therapy for Insomnia

The investigators will conduct a randomized, controlled trial of internet-based cognitive behavioral therapy (iCBT) vs usual care for insomnia. The target population is patients prescribed medications for insomnia who have not had a dispensation of these medications in the preceding six months. The primary outcomes is dispensed days supply over the subsequent one year. Secondary outcomes include all types of health system clinical encounters. The investigators hypothesize that the group randomized into iCBT will have less insomnia medications dispensed than usual care controls, and less clinical encounters..


Eligibility Criteria:
Inclusion Criteria:

* A prescription for any of a set of selected insomnia medications.
* Age \>18 years at the time of the prescription.
* A recent (\<30 days before the prescription date) diagnosis of insomnia as determined by a set of selected International Classification of Disease (ICD) codes, to be used for medications that are not prescribed just for insomnia.
* Membership for \>365 days prior to the prescription date.
* No evidence of a dispensed insomnia medication within six months (183 days) of the current prescription.

Exclusion Criteria:

* Contained in inclusion criteria.
The Platelet-Rich Plasma in the Therapy of Temporomandibular Disorders

The Platelet-Rich Plasma intramuscular injections into the masseter and temporalis muscle were performed to reduce painful temporomandibular disorder symptoms,such as myalgia, myofascial pain and myofascial pain with referrals. Patients(n=120) were randomly divided into two groups: experimental(n=60) and control group(n=60). In controls injections with 0,9% NaCl were performed. Pain intensity was measured with NPRS (numeriic pain rating scale, 0= no pain, 11= the worst pain that one can imagine) before(0 day), during(10 day) and after(20 day) the therapy with PRP injections.

Patients(n=120) attending The Department of Temporomandibular Disorders and Orthodontics at the Silesian Medical University Poland, Zabrze were enrolled to the study and randomly divided into one of two groups: experimental and control group. Platelet-Rich Plasma(PRP) was prepared for each patient and an intramuscular injections of 0,5 ml PRP into 6 points at each side were performed in experimental group. A follow-up appointment was made after 10 and 20 days and in each visit an injection of PRP or 0,9% NaCl was performed. Pain intensity was measured in NPRS(numeric pain rating scale) and collected data data were analyzed.

Eligibility Criteria:
Inclusion Criteria:

1. presence of local myalgia, myofascial pain and myofascial pain with referral within masseter muscles according to the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) (II.1.A. 1, 2 and 3)
2. patient's agreement for taking part into the research study

Exclusion Criteria:

1. patients being treated with or addicted to analgesic drugs and/or drugs that affect muscle function
2. presence of contraindications for injection therapy
3. patients being treated by neurologist for neurological disorders and/or neuropathic pain and/or headache
4. patients after traumas to the head and neck region in the previous 2 years
5. edentulous patients
6. patients after radiotherapy
7. presence of severe mental disorders
8. pregnancy or lactation
9. pain of dental origin
10. presence of malignancy
11. drug and/or alcohol addiction
12. patients with needle phobia
B Cell Response to a Primary and a Booster Course of the Novartis Meningococcal ACWY Conjugate Vaccine in Healthy Infants

This study is aimed to assess whether the frequency of meningococcal serogroup A, C, W-135 and Y specific memory B Cells, measured 1 month after a primary vaccination series of Novartis MenACWY vaccine, predicts the specific serum bactericidal activity using human complement (hSBA) of (respectively) serogroup A, C, W-135 and Y at 12 months of age


Eligibility Criteria:
Inclusion Criteria:

Subjects who were eligible to be enrolled in the study:

* healthy infants aged 2 months (56 - 83 days old, inclusive);
* available for the visits scheduled in the study;
* mother available for blood draw at Visit 1;
* good health as determined by the clinical judgement of the investigator;
* whose parents gave written informed consent for the infant to be enrolled in the study. The infant's parents must have been willing for the infant to receive the full primary immunization course.

Exclusion Criteria:

Subjects who were not eligible for the study were those:

* whose parents had not given or were unwilling or unable to give written informed consent to their child's participation in the study
* with known hypersensitivity to any vaccines contained within the routine immunization schedule
* with unacceptable concurrent illnesses or conditions - e.g.:

  1. a severe acute or chronic illness; with any present or suspected serious disease such as metabolic, cardiac or autoimmune disease or insulin dependent diabetes or with any other serious disease (e.g., with signs of cardiac or renal failure or severe malnutrition), including progressive neurological disease;
  2. a genetic anomaly, e.g. Down's syndrome;
  3. any immunodeficiency, including use of systemic corticosteroids;
  4. born at less than 36 weeks gestation;
  5. weighing less than 2.5 kg at birth;
  6. previous clinical or bacteriological diagnosis of meningitis, or with a history of household contact or intimate exposure to an individual with culture proven Neisseria meningitidis disease;
  7. known bleeding diathesis, or any condition associated with a prolonged bleeding time;
* who have received any prohibited prior or concomitant medications - e.g.:

  1. any immunizations within the 30 days prior to enrollment, with the exception of BCG or hepatitis B;
  2. immunoglobulin;
  3. any blood products;
* participating in any other clinical trial either currently or in the previous month;
* unable to adhere to the protocol, including plans to move from the area;
* Other:

Had any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
Effects of Glucosamine and Chondroitin Sulfate Supplementation in Addition to Resistance Exercise Training and Manual Therapy in Patients With Knee Osteoarthritis

Osteoarthritis (OA) IS one of the most common joint disorders, affecting not only the joints but also the surrounding muscles, which become weak. Resistance exercise reduces pain and improves function in patients with OA of the knee. Nonsteroidal anti-inflammatory drugs (NSAIDs) are widely used by patients with OA to reduce pain and thereby maintain the ability to perform daily activities. However, there is accumulating evidence for a negative effect of NSAIDs, thus many patients with OA are treated with dietary supplementations such as glucosamine and chondroitin sulfate, and some studies show a beneficial effects on cartilage and pain. However, their effect on OA symptoms and cartilage remains controversial. Thus, it is important to investigate whether a potentially beneficial effect of glucosamine and chondroitin sulfate with resistance exercise and manual therapy in patients with knee OA.


Eligibility Criteria:
Inclusion Criteria:

* knee osteoarthritis for at least 3 months
* knee pain no more than 8/10
* Grade III or less on radiograph (Kellgren classification)

Exclusion Criteria:

* Malignancy
* Any additional Inflammatory disorders
* Infection
* Knee trauma
* lower limb fracture
* Lumbar radiculopathy or myelopathy
* knee surgery or replacement
* Intra-articular steroid therapy in the last 2 months
Collaboration to Promote Early Childhood Well Being in Families Experiencing Homelessness

The purpose of this study is to help us learn what are the best services to promote young children's healthy development for families who are experiencing homelessness. Participants may participate in three programs: 1. Healthy Home: four weekly, one-hour group sessions on health topics; 2. Attachment and Biobehavioral Catch-up (ABC): 10, one-hour parenting with parent and child; 3. Healthy Steps: helps families identify, understand and manage parenting challenges completed at well child visits. Participants will be asked to complete surveys, participate in focus groups, and interviews about the experiences with the services offered. Questionnaires about understanding health issues and surveys about parenting behaviors and self-efficacy will also be completed. Study duration is approximately 10 - 12 weeks. Programs may be continued once families move into permanent housing.


Eligibility Criteria:
Inclusion Criteria:

* Head of household of families living at FMF with at least one child under 48 months.
* All subjects must be English speaking and able to give legally effective consent.

Exclusion Criteria:

* Non-English speaking subjects
An Extension To The B1451027 Protocol To Evaluate The Long Term Safety And Tolerability Of Dimebon In Patients With Alzheimer's Disease

The purpose of this study is to evaluate the long-term safety and tolerability of Dimebon in patients with Alzheimer's disease.

This study was terminated on May 7, 2010 as part of modification of the dimebon development plan following lack of demonstration of efficacy in the completed DIM14 (CONNECTION) Study. The study was not terminated due to any safety findings. Dimebon has been well -tolerated in clinical trials. Demonstration of efficacy for dimebon in Alzheimer's disease is pending completion of the ongoing DIM18 (CONCERT) Study.

Eligibility Criteria:
Inclusion Criteria:

* Completion of previous Phase 3 Dimebon study (B1451027).

Exclusion Criteria:

* Have any severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
Evaluation of an Open-source Speech-processing Platform

Determining acceptability and usability of a wearable open-source speech processing platform (Master Hearing Aid) developed for hearing-aid research

Part 1 Speech perception tests. You will hear words and sentences under a variety of listening conditions and be asked either to either repeat them or to select what you heard from a set of options. You will also answer a few questions about the speech and the background noise. The goal is to determine the ability of the most recent version of the device to deliver good quality speech that is comfortable and understandable over a range of conditions that are representative of everyday listening.

Part 2. Suitability and Acceptability. You will be asked to respond to a short structured interview about the device. If the device has reached a wearable stage, you will wear it outside the laboratory while engaging in discussion with one of the researchers before completing the interview. The goal is to obtain the opinions of persons with hearing loss about the device itself, and about their willingness to wear it as a hearing aid in their everyday life, if they were to be involved in a research study.

Part 3 is a focus-group session with about 10 hearing-aid users, some of whom will have participated in Parts 1 and 2. Topics will deal with hearing aids in general and about the current version of the experimental device. Discussion will be recorded for later transcription and analysis. The goal is to gain the perspective of hearing-aid users about hearing aids, hearing-aid research, and the acceptability of this experimental device for field research.

Eligibility Criteria:
Inclusion Criteria:

- Sensorineural hearing loss

Exclusion Criteria:

* Cognitively challenged
* Legally blind