cyrilzakka/clinical-trials huggingface dataset:
Remote Monitoring in Diabetes Disease Management

The primary objective of this study is to determine whether remote monitoring in diabetes management is more effective at helping patients manage their disease than a standard disease management program.

To determine whether remote monitoring in diabetes management is more effective at helping patients manage their disease.

Eligibility Criteria:
Inclusion Criteria

* Between 18 and 64 years of age as of January 1, 2008
* Diagnosis of diabetes mellitus (listed ICD-9-CM diagnosis code on two or more outpatient claims, or on one or more inpatient admissions or emergency room claims in the most recent 12-month period)
* Continuously enrolled in a health plan with pharmacy and medical benefits for the most recent 12-month period or with one period of non-enrollment up to only 30 days
* Able to provide written informed consent for study participation

Exclusion Criteria

* Advanced renal disease (one or more claims in the most recent 12-month period) as defined by a claim for nephropathy or creatinine greater than 2.5 mg/dl
* Selected cancers (one or more claims in the most recent 12-month period)
* HIV/AIDS (one or more claims in the most recent 12-month period)
* Heart, liver, kidney, or multiple organ transplant (one or more claims in the most recent 12-month period)
* Cirrhosis of the liver (one or more claims in the most recent 12-month period)
* Current participation in another LifeScan study or other diabetes-related clinical trials
* Medicare is primary source of insurance coverage
* Unable to understand written and spoken English
The Pharmacokinetics of MK-7145 Following Single Dose Administration in Participants With Moderate Renal Insufficiency (MK-7145-018)

The primary purpose of this study is to obtain a preliminary pharmacokinetic profile of MK-7145 2 mg immediate release (IR) following single-dose administration in male participants with moderate renal insufficiency. In addition, the study will evaluate the pharmacodynamic effect of a single dose of MK-7145 2 mg IR on 24-hour net natriuresis in male participants with moderate renal insufficiency.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) 18 to 35 kg/m\^2
* Nonsmoker and/or have not used nicotine or nicotine-containing products

for at least 3 months prior to enrollment

* Estimated glomerular filtration rate (eGFR) 30 to 60 mL/min/1.73 m\^2

Exclusion Criteria:

* History of stroke, chronic seizures, or major neurological disorder
* Ongoing, clinically significant endocrine, gastrointestinal, cardiovascular,

hematological, hepatic, immunological, respiratory, or genitourinary abnormalities or diseases

* Systolic blood pressure (SBP) ≤95 mmHg or \>160 mmHg, or diastolic blood

pressure (DBP) ≤45 mmHg or \>95 mmHg

* History of neoplastic disease except for adequately treated non-melanomatous skin carcinoma
* Unable to refrain from, or anticipates the use of, strong/moderate cytochrome P450 3A4 (CYP3A4) inhibitors
* Consumes excessive amounts of alcohol, defined as greater than 3 glasses of alcoholic beverages, wine, or distilled spirits per day
* Consumes excessive amounts of caffeine, defined as greater than 6 servings of coffee, tea, cola, or other caffeinated beverages per day
* Had major surgery or donated blood within 8 weeks prior to enrollment
* Has participated in another investigational study within 4 weeks prior
* History of significant multiple and/or severe allergies (including latex allergy), or has had an anaphylactic reaction or significant intolerance to prescription or nonprescription drugs or food
* Currently a regular user of illicit drugs, or has a history of drug (including alcohol) abuse within approximately 6 months
* Has active or has a history of nephrolithiasis
* Has had a kidney removed or has a functioning renal transplant
Evaluation of the Prognostic Value of Biological Markers, Coll2-1 and Coll2-1NO2 in Patients With Symptomatic Knee Osteoarthritis

The purposes of this study are to assess the prognostic value of serum and urinary biomarkers Coll2-1 and Coll2-1NO2 at baseline, and their change over the first year, on the progression of knee osteoarthritis MRI scores at 12 months, on the progression of knee osteoarthritis clinical score at 12 months. Additionally, this study will search for correlations between serum and urinary biomarkers Coll2-1 and Coll2-1NO2 at baseline with the radiographic, MRI and clinical severity of knee osteoarthritis.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged 45 to 80 years with a BMI ≤ 40
* With an uni- or bilateral femorotibial knee osteoarthritis associated or not with a femoro-patellar knee osteoarthritis
* Responding to clinical and radiological criteria of the ACR
* Symptomatic for more than 6 months (for the most painful knee)
* K\&L radiological grade of Felson II or III
* With a cartilage lesion identified during MRI and either at least 1 out of 4 MRI severity criteria:

  * bone oedema
  * meniscal lesion in the central region of the medial compartment
  * effusion without answer to corticosteroids
  * zone without cartilage
* or at least 1 out of 3 clinical severity criteria:

  * genu varum\>3°
  * previous meniscal surgery
  * known polyarthritis
  * effusion on the target knee
* Sign an informed consent after being informed
* Able to follow the instructions of the study
* With an agreement from the physicians having established the diagnosis of osteoarthritis (if any) to give relevant information to the investigator
* With health insurance (for France).

Exclusion Criteria:

For osteoarthritis:

* Isolated patellofemoral arthritis
* Chondromatosis or villo-nodular synovioma of the knee
* Recent trauma-induced knee pain
* Joint disease due to joint dysplasia, aseptic osteonecrosis, acromegaly, Paget's disease, hemophilia, hemochromatosis, ...
* inflammatory pathologies as rheumatoid polyarthritis, gout arthritis, infectious arthritis
* Diseases that may interfere with the evaluation of osteoarthritis (radiculalgia of lower limbs, arteritis, ...)
* Genu valgum (degree considered as pathological by the physician)

For previous treatments:

• Treatment with strontium ranelate, bisphosphonates, SERM and PTH

For known associated diseases:

* Serious associated diseases: severe liver or renal failure, uncontrolled cardiovascular disease, HIV, hepatitis B or C
* Knee tumor

For patients:

* Patient who participated to a therapeutic clinical trial 3 months before the T0 inclusion visit
* Patient who are the subject of a judicial protection measure or under guardianship
* Pregnant woman

For MRI contraindications:

* Patient with a pacemaker, an implantable defibrillator, neurosurgical clips, a neurostimulator, cochlear implant, a stent, an insulin pump
* Patient with a ferromagnetic splinter in the body, or having wire sutures
* Serious mobility problem (Parkinson, tremors)
Effects of Static Apnea at High Lung Volume on Hypoalgesia, Cardiovascular Function and Respiratory Function

The aim of this randomized controlled study is to explore the hypoalgesic response of a 6 minutes of intermittent static apneas training session at high lung volume in healthy subjects; also, as secondary objectives, to analyze the cardiovascular and respiratory response produced during the intervention.


Eligibility Criteria:
Inclusion Criteria:

- Asymptomatic subjects aged between 18 and 64 years.

Exclusion Criteria:

* Cardiovascular, respiratory, metabolic, neurological or osteomuscular signs or pathologies.
* History of epilepsy.
* Pregnant.
* Pharmacological treatment.
* Participants who present any type of pain on the day of the measurements or who have frequently suffered pain during the previous 4 weeks.
The Impact of Mobile APP Intervention ( iCKD APP) on Chronic Kidney Disease Care

* Apply Mobile APP Intervention ( iCKD APP) to current chronic kidney disease care program.
* Conduct a randomized clinical trial to evaluate the clinical effectiveness of this mobile device on health behavior improvement in chronic kidney disease patients.

A mHealth app (iCKD APP) was designed to assist CKD patients to monitor their home bio-information data. Patients will be randomly assigned into the iCKD APP group(intervention) and traditional care group (control). Participants will be randomized into an 1:1 manner (intervention : control). Random assignment occurred after the consent and initial enrollment interview. Individuals randomized to the iCKD APP will provide with the equipment after randomization. Participants will follow for at least 6 months before the exit interview.

Eligibility Criteria:
Inclusion Criteria:

* Subjects are 20 years old and above, Chinese speaking, and able and willing to provide informed consent.
* Subjects own mobile devices such as cell phones and tablets.
* Subjects were diagnosed with Chronic Kidney Diseases and were taking a single antihypertensive agent for more than three months or they are not receiving treatment but with systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg.

Exclusion Criteria:

* starting dialysis or having a kidney transplant (RRT)
* participating in other interventional study
* cognitively impaired
* unable to give consent
* life expectancy less than 1 year
Photo Neuro-Modulation Therapy to Adults

It is well-documented that mild cognitive impairment (MCI) is associated frontal lobe dysfunction and executive dysfunction. In addition, many studies reported high level of MCI symptoms among the elderly and the trend is increasing in Hong Kong. Based upon the link between MCI and frontal and executive function problems, it is conceivable that elderly who exhibits high levels of memory problems would exhibit frontal and executive function problems. To our knowledge, there is still a lack of effective treatment or therapy for MCI, it is important to investigate effective intervention that can efficiently improve the cognitive ability of MCI patients or patients with mild memory problems. The objective of the present study is to compare individuals with mild memory problems after the Photo neuro-modulation Therapy (PNMT) and those who do not. 40 middle aged and older adults were recruited from the subject database of the Neuropsychology Laboratory of The Chinese University of Hong Kong. Participants were divided randomly and equally into treatment group, as well as the placebo group. Several computerized executive function tests will be used before and after the treatment under the recording of near-infrared spectroscopy (NIRS), which estimates level of frontal activation. It is hypothesized that compared to participants without PNMT, those with PNMT will have a better performance in the executive function tasks and exhibit a higher frontal activation. The cognitive and neurophysiological results would provide evidences on the possibility of PNMT in treating individuals with mild memory problems, as well as with other mental disorders.


Eligibility Criteria:
Inclusion Criteria:

* 40 middle age and older adults with aged 40 or above who have subjective memory complaints

Exclusion Criteria:

* A history of head injury, or any neurological/psychiatric disorders, and dementia will be excluded. In addition, a score higher than 7 on the short form of the Chinese Geriatric Depression Scale (CGDS-SF; Lee, Chiu, Kwok, \& Leung, 1993)
Online Program for Coaching Girls: Coaching HER

Despite the numerous physical and psychological benefits of taking part in sport, studies consistently show that only 15% of adolescent girls globally meet the recommended daily exercise guidelines (Guthold et al., 2018). The team climate, created by coaches, has been identified as a critical factor in both girls' participation in, and enjoyment of, sport and movement (CITE). Research indicates that girls disengage from sport because of body image concerns, uncomfortable and objectifying uniforms, appearance-related teasing from peers and coaches, untrained coaches, and negative team cultures (Murray et al., 2021; Vani et al., 2021).

help coaching girls books as another form of media that produces "commonsense proof" of girls' sport inferiority, essentializes gender differences, reifies the gender binary (Kane, 1995), and marginalizes the sport participation of girls.

The beliefs, values and expectations of significant adults can positively or negatively influence self-perceptions, motivation, experiences, and behaviors of children (Fredricks \& Eccles, 2005; Brustad et al., 2001) and also directly influence the coaching behaviors of adults (Cassidy et al., 2005).

The 'coaching girls' books examined for this study were formulaic products written from a perspective of difference, "despite extensive evidence from meta-analysis research of gender differences which supports the gender similarity hypothesis" (Hyde, 2005, p.590).

ambivalent and primarily non-research based messages contained within the books trivialize, misrepresent, distort, and marginalize girls' emotions, thoughts, relationships, skills and behaviors in sport contexts (Birrell \& Theberge, 1994), while upholding coaching boys as normative praxis. Coaching girls books appear to "help" coaches of female athletes, while simultaneously reifying gender stereotypes that undermine female empowerment that can occur in and through sports.

Praxis based on gendered beliefs of inherent difference is dangerous as it can undermine male-female relationships as well as beliefs of equality, and deprive all children of the opportunity to develop their full human potential (Barnett \& Rivers, 2004). Coaches must be aware that coaching is a gendered practice in which beliefs and values are enacted, sometimes in ways that limit the experiences of their athletes.

On the other hand, sport participation can improve girls' self perceptions and lead to accrual of health and development assets if the coach and adults in the context are aware of the gendered nature of sport, and strive to eliminate deleterious effects (LaVoi, 2018).

This study will test an educational program for coaches aimed at reducing gender essentialist beliefs and gender stereotypes of coaches, to improve the sport experience for girls.


Eligibility Criteria:
Inclusion Criteria:

* Current Coaches of adolescent girls
* English speaking
* U.S. resident

Exclusion Criteria:

* Participants under 18 years of age
* Coaches outside of the US
* Coaches who only coach adult women or men/boys
Phase 2 Study of Ipilimumab in Children and Adolescents (12 to < 18 Years) With Previously Treated or Untreated, Unresectable Stage III or Stage lV Malignant Melanoma

The purpose of the study is to comply with the Pediatric Investigation Plan requirements of Ipilimumab


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

Inclusion Criteria:

* 12 \< 18 years of age
* Previously treated or untreated, unresectable Stage III or Stage IV malignant melanoma
* Karnofsky Performance Status (KPS) or Lansky Score ≥ 50

Exclusion Criteria:

* Primary Ocular Melanoma
* Prior therapy with a Cytotoxic T Lymphocyte Antigen 4 (CTLA-4) or Programmed death- 1 (PD-1) antagonist, or Programmed cell death- ligand 1 (PD-L1) or CD137 agonists
* Symptomatic brain metastases
* History of autoimmune diseases
Efficacy and Safety of IDP-124 Lotion for the Treatment of Moderate to Severe Atopic Dermatitis in Pediatric and Adult Subjects (301)

Efficacy and Safety of IDP-124 Lotion for the Treatment of Moderate to Severe Atopic Dermatitis in Pediatric and Adult Subjects

A Multicenter, Randomized, Double-Blind, Vehicle-Controlled, Study to Evaluate the Efficacy and Safety of IDP-124 Lotion for the Treatment of Moderate to Severe Atopic Dermatitis in Pediatric and Adult Subjects

Eligibility Criteria:
Key Inclusion Criteria:

* Male or female at least 2 years of age and older
* Written and verbal informed consent must be obtained; subjects less than age of consent must sign an assent for the study and a parent or a legal guardian must sign the informed consent (if subject reaches age of consent during the study they should be re-consented at the next study visit)
* Nonimmunocompromized male or female who failed to respond adequately to other topical prescription treatment for AD or for whom those treatments are not advisable
* Subjects must be willing to comply with study instructions and return to the clinic for required visits; subjects under the age of consent must be accompanied by the parent or legal guardian at the time of assent/consent signing

Key Exclusion Criteria:

* Females who are pregnant, breast feeding, or who wish to become pregnant during the study period
* Active cutaneous bacterial or viral infection in any treatment area at Baseline (eg, clinically infected AD)
* Sunburn, extensive scarring, or pigmented lesion(s) in any treatment area at Baseline, which would interfere with evaluations
* History of confounding skin conditions, eg, psoriasis, rosacea, erythroderma, or ichthyosis (other than ichthyosis vulgaris)
The Effect of Adhesiolysis During Elective Abdominal Surgery on Per- and Postoperative Complication, Quality of Life and Socioeconomic Costs

Official title:

LAPAD - A prospective study on the effect of adhesiolysis during elective laparotomy or laparoscopy on per- and postoperative complication, quality of life and socioeconomic costs

Background:

With improved surgical technology and ageing of the population the number of reoperations in the abdomen dramatically increases. The risk for a repeat laparotomy or laparoscopy is a high as 30% in the first ten years after a laparotomy. In over 95% of reoperations adhesiolysis is required to gain access to the abdominal cavity and operation area. Adhesiolysis significantly increases the risk for inadvertent organ damage, such as enterotomies, leading to higher morbidity, mortality and socioeconomic costs.

Purpose:

To define the impact of adhesiolysis on per- and postoperative complications, quality of life and socioeconomic costs.

Design:

Prospective observational study.

Primary outcomes:

* adhesiolysis time
* inadvertent enterotomy
* seromuscular injury
* miscellaneous organ damage
* Serious adverse events of operation (anastomotic leakage, delayed diagnosed perforation, wound infection, abdominal infection, haemorrhage, pneumonia, urinary tract infection, abscess, fistula, sepsis, death)

Secondary outcomes:

* Hospital stay
* Intensive care admission
* Reinterventions
* In-hospital costs
* Parenteral feeding
* Short term readmissions (30 days)
* Quality of life (Gastro- intestinal tract complaints, Short Form- 36(SF-36), DASI (Duke Activity Score Index(DASI) )

Estimated enrollment: 800 start study: 1 june 2008 Inclusion completion date: 1 june 2010 Estimated study completion date: 1 february 2011


Eligibility Criteria:
Inclusion Criteria:

* Planned elective laparotomy or laparoscopy
* Mentally competent
* 18 years or older

Exclusion Criteria:

* Operation cancelled
* Bad quality of data
Breathing Therapy for Patients in General Practice

Medically unexplained physical symptoms (MUPS) capture conditions characterized by symptoms without corresponding objective findings, such as asthenia, low back pain, fibromyalgia, irritable bowel syndrome, or chronic fatigue syndrome. In order to establish the grounds for a RCT. this pilot study aims to investigate the effectiveness and feasibility of a 5-week breathing retraining programme on patients who meet the criteria for MUPS.

Medically unexplained physical symptoms (MUPS) are symptoms without an identifiable organic cause that lead to functional impairment. MUPS is highly prevalent in general practice consultations. This pilot study aimed to investigate the effectiveness and feasibility of a 5-week breathing retraining program for patients meeting the criteria for MUPS. The study used a quantitative observational design with pre- and post-intervention measurements. Fifteen participants with MUPS and dysfunctional breathing (assessed by the Nijmegen Questionnaire) were recruited from two general practitioner offices. The intervention consisted of 5 weekly sessions including education on breathing physiology and weekly breathing exercises focused on nasal breathing and resonance breathing techniques. One week post intervention, improvements were observed in dysfunctional breathing scores, lower symptom severity, higher general well-being, and reduced musculoskeletal pain complaints. At 3 months post-intervention, sustained improvements were seen in dysfunctional breathing, general well-being, musculoskeletal pain, and additionally lower pseudoneurological, gastrointestinal, and allergy complaints, as well as lower overall symptom burden and improved end-tidal CO2 levels.

The study concluded that the 5-week breathing program showed promising results for improving multiple patient-reported outcomes in MUPS. Recruitment, adherence, and acceptability of the program were satisfactory. A randomized controlled trial is recommended to further evaluate the efficacy of this breathing intervention for MUPS patients.

Eligibility Criteria:
Inclusion Criteria:

* 18 years
* dysfunctional breathing,
* sufficient laguage skills to fill out forms

Exclusion Criteria:

* Participants with asthma
* Participants with,chronic obstructive pulmonary disease
* Participants with respiratory allergy that is not optimally treated medically.
A Clinical Trial to Evaluate the Safety and Tolerability of TQB3911 Tablets in Patients With BCR::ABL Fusion Gene Positive Leukemia

Phase I clinical trial to explore the safety, tolerability, and initial efficacy of TQB3911 tablets in BCR::ABL fusion gene positive leukemia.


Eligibility Criteria:
Inclusion Criteria:

* The subjects voluntarily joined the study, signed the informed consent, and had good compliance;
* Age: ≥18 years old (when signing the informed consent); Eastern Cooperative Oncology Group Performance Status (ECOG PS) score: 0-2; Expected survival of more than 3 months;
* During the screening period, the patients were identified as Chronic myelogenous leukemia-Chronic phase (CML-CP) or accelerated phase (AP) patients by bone marrow cell morphological examination, molecular biological examination or cytogenetic examination;
* Chronic myelogenous leukemia (CML) patients who are intolerant to Tyrosine kinase inhibitors (TKI) drugs or whose therapeutic effect is not satisfactory (that is, the therapeutic response evaluation result is failure)
* The main organs function well
* Female subjects of reproductive age should agree to use contraceptives (such as Iuds, contraceptives, or condoms) during the study period and for 6 months after the end of the study; Have a negative serum pregnancy test within 7 days prior to study enrollment and must be a non-lactating subject; Male subjects should agree to use avoidance during the study period and for 6 months after the end of the study period.

Exclusion Criteria:

* Had or was currently suffering from other malignant tumors within 5 years before the first medication
* Combined with active central nervous system leukemia
* Major surgical treatment and significant traumatic injury were received within 28 days before the start of study treatment
* Previous history of myocardial infarction, pulmonary hypertension, or angina pectoris within 3 months before the first medication, or clinically significant arrhythmias such as ventricular tachycardia, complete left bundle branch block, and high atrioventricular block
* Acute pancreatitis and a history of chronic pancreatitis within 12 months before the first medication
* History of interstitial lung disease, radiation pneumonia requiring steroid treatment, or drug-related pneumonia
* Patients with CML-CP who have achieved complete cytogenetic response (CCyR)
* Received live attenuated vaccine within 4 weeks before the first dose, or planned to receive live attenuated vaccine during study participation
* Use of drugs that may have caused QT prolongation or tip torsical tachycardia in the 7 days prior to initial administration, or continuation of these medications during the study period