cyrilzakka/clinical-trials huggingface dataset:
The Benefits of Intensive Glycemic Control in Elderly Patients With Type 2 Diabetes

Aims/hypothesis:

Populations worldwide are aging and type 2 diabetes is common in individuals aged \>80 years. The important issue that needs to be considered is whether tight glycemic control is benefits for elderly patients with type 2 diabetes. The benefits of intensive glucose control remain uncertain for the heterogeneous population of older diabetic patients due to a lack of clinical trial data evaluating the benefits of long-term intensive glucose control in older patients. This study is designed to provide reliable evidence on the balance of benefits and risks conferred by intensive glucose control in elderly patients with type 2 diabetes Methods: This is a prospective, randomized, open-labeled, controlled design to assess the benefits of treating elderly patients with type 2 diabetes. The study will include 208 elderly patients with type 2 diabetes and follow-up for 5 years. Eligible patients are randomized to receive intensive (A1C \<7.0%) or conservative (A1C around 8.0%) glycemic control. The primary study outcomes are a composite of macrovascular events and a composite of microvascular events, considered both jointly and separately. The secondary outcomes are death from any cause, death from cardiovascular causes, total coronary events, total cerebrovascular events, heart failure, peripheral vascular events, all cardiovascular events, and hospitalization for 24 hours or more.

Expected results: This study is designed to provide reliable evidence on the balance of benefits and risks conferred by intensive and conservative glucose control in elderly patients with type 2 diabetes. Once completed, this trial will clearly influence the management of elderly patients with type 2 diabetes, regardless of the results.


Eligibility Criteria:
Inclusion Criteria:

* Men or women aged ≥80 years at time of randomization.There is no upper age limit.
* Be able to walk by themselves
* They had their first diagnosis of type 2 diabetes mellitus at age 30 years or older.

Exclusion Criteria:

* Known advanced diabetic complications (such as proliferative retinopathy, chronic kidney disease stage IV or above).
* Overt clinical congestive heart failure (CHF) requiring treatment with a diuretic or ACE inhibitor.
* Previous documented cerebral or subarachnoid haemorrhage in the last 6 months
* Condition expected to severely limit survival
* Clinical diagnosis of dementia
* Resident in a nursing home
Alert Frequency, Nurse, and Patient Satisfaction With a wCVSM Software Across Health Care Systems and Cultures

The goal of this prospective, international multi-centre pilot study is to assess the functionality and user experience of a new vital sign monitoring system in 20 patients and 20 nurses in the general ward at each centre. The patients will be monitored with a wireless, continuous vital sign monitoring systems and answer a questionnaire afterwards. They will in addition have vital signs monitored as per standard practice. The nurses will answer a questionnaire after having had the responsibility for a monitored patient for a full shift. The main aims are: To determine the frequency of alerts activated in the app in relation to the alerts that should be activated based on measured data, to explore current practices of in-hospital monitoring by semi-structured interviews to map differences across systems and to test nurse and patient satisfaction.

The participants will be monitored for 4 days postoperatively or for 4 days after acute admission and until discharge.

Monitoring devices used in this study will be validated FDA or/and CE approved devices used within their original purpose. Centers can choose to use Sotera Visimobile or Isansys Lifeguard with accompanying sensors. These devices will be used together with the CE approved WARD web and mobile application.

Study sites include: St. Olav Hospital Trondheim, Royal Liverpool University Hospital, University Medical Centre Hamburg-Eppendorf,University Medical Centre Groningen, The Netherlands and the Cleveland Clinic.

Eligibility Criteria:
Inclusion Criteria:

* Adults (≥18 years)
* Expected stay in the hospital ≥2 days
* Admitted for surgery with expected duration of surgery \>2 hours or admitted for acute medical condition with at least one of the following vital sign deviations within 24 hours of acute admission, recorded by the staff

  * RR \> 21 breaths pr minute
  * RR \< 11 breaths pr minute
  * Pulse (P) \> 91 beats pr minute
  * Pulse (P) \< 50 beats pr minute
  * SpO2 \< 94 % without oxygen supplementation
  * Systolic BP \< 110 mmHg
  * Systolic BP \> 220 mmHg

Exclusion Criteria:

* Participant expected not to cooperate with study procedures.
* Allergy to plaster or silicone.
* Pacemaker or Implantable Cardioverter Defibrillator (ICD) device.
* Inability to give informed consent.
A Retrospective Chart Review of Deceased Patients With Mucopolysaccharidosis Type IIIB

The objective is to perform a retrospective chart review to generate data to evaluate the clinical characteristics and course of disease progression of MPS IIIB.


Eligibility Criteria:
Inclusion Criteria:

1. The deceased patient was diagnosed with MPS IIIB as determined by either of the following:

   1. Documented deficiency of NAGLU enzyme activity.
   2. Documented functionally-relevant mutations in both alleles of the NAGLU gene.
2. Patient's parent or legal guardian provides informed consent (unless the requirement for informed consent is waived by local regulations).
3. The availability of pre-defined information in the patient's clinical chart:

Exclusion Criteria:

There are no exclusion criteria for this study.
Platelet-rich Plasma Injections for Persistent Medial Knee Pain After Total Knee Arthroplasty

This study will investigate the potential effects of platelet rich plasma for the treatment of persistent medial knee pain after total knee arthroplasty. All study participants will receive PRP injections and will be followed up to see if any benefit in regards to pain and/or function is achieved.

This study aims to investigate the efficacy of platelet-rich plasma (PRP) injections for the treatment of persistent medial knee pain after total knee arthroplasty (TKA). The investigators hypothesize that PRP injections will provide meaningful pain relief and improved functionality for patients suffering from post-TKA residual pain. The incidence of residual pain after TKA ranges between 10-34%. Many of these patients can be effectively managed by physical therapy, orthotics, and pes anserine bursa corticosteroid injections. However, there remain a number of refractory cases that are frustrating for both the patient and physician. With the advent of interventional pain management, advanced interventions for this clinical problem have focused on selective nerve blocks and ablations targeting the infrapatellar branch of the saphenous nerve. More recently, attention has been paid to the role of patient biology and inflammatory mediators in the development of post-arthroplasty pain (including IL-6 and CRP). If individual patient biology is the foundation of post-TKA pain, then biologic interventions aimed at restoring the balance of these mediators (such as PRP), rather than ablative procedures, seems preferable. Furthermore, while intra-operative PRP has been studied for its effects on wound healing, blood loss, and post-operative pain control, no study has investigated its utility in treating residual medial knee pain after TKA.

All injections will be performed by the same board-certified sports medicine and musculoskeletal ultrasound physician. There will be no activity restrictions following the procedure.

Descriptive statistics will be used to report mean changes in outcome scores. Data will be analyzed with a 2-sample t-test.

Eligibility Criteria:
Inclusion Criteria:

1. Person has had a total knee arthroplasty (total knee replacement)
2. Has experienced persistent medial knee pain beyond six months after surgery
3. Has the presumed diagnosis of pes anserine bursitis
4. No pain relief with conventional treatments such as arch supports (if one is flatfooted), NSAID's, and at least two local steroid injections

Exclusion Criteria:

1. Person has had a prior knee surgical procedure other than the total knee arthroplasty or an arthroscopic debridement procedure
2. Evidence of knee instability, prosthetic loosening, knee infection, radiculopathy, or hip or back pain
3. Personal history of chronic narcotic or recreational drug use, smoking, psychiatric disorders, or a total hip arthroplasty on the same side of the knee arthroplasty
4. Body mass index (BMI) of greater than 35
Lubinus SPII Hip Stem Target Trial Emulation (LARGE)

The research questions this study aims to answer are as follows:

Primary research question:

"Do primary total hip arthroplasties for patients with OA, hip fracture or osteonecrosis with the 150mm Lubinus SPII hip stem have better mortality and stem revision rates than primary total hip arthroplasties with the 130mm hip stem?"

Secondary aims include:

* How does line-to-line cementation, compare to undersized cementation in primary total hip arthroplasty for patients with OA, hip fracture, or osteonecrosis when comparing equal size Lubinus SPII hip stems implanted with different cementation techniques?
* Does the Lubinus SPII 150mm hip stem perform equal to the Lubinus SPII 130mm hip stem in primary total hip arthroplasties for patients with OA, hip fracture or osteonecrosis when comparing patient reported outcome measures?

To answer these questions, this study has been allowed use of registered data from the LROI (dutch arthroplasty registry) and the SAR (swedish arthroplasty registry). After exclusion of patients who did not meet inclusion criteria between 2007-2020, approximately 110000 patients remain eligible for analysis.


Eligibility Criteria:
Inclusion Criteria:

* Listed in registry for primary hip arthroplasty.

  * Listed in registry with an indication of osteoarthritis, osteonecrosis or hip fracture.
  * Received the Lubinus SPII hip stem, 130mm or 150mm, for their primary hip arthro- plasty.
  * End point listed in registry (Alive, Deceased or revision).

Exclusion Criteria:

* Patients who received the Lubinus SPII 150 XL conus stem.
Chemotherapy-free Regimen of Venetoclax, Azacitidine Plus Orebatinib (VAO Regimen) for Newly Diagnosed ph+ALL

The purpose of this study is to evaluate the efficacy and safety of Venetoclax, Azacitidine Plus Orebatinib in newly diagnosed Philadelphia chromosome-positive Acute Lymphoblastic Leukemia.

This is a phase Ⅱ, single-arm, open Label, multicenter clinical study in newly diagnosed Ph-positive acute lymphoblastic leukemia patients. The patients will receive venetoclax, azacitidine and orebatinib regimen in the induction treatment. The patients who respond to induction treatment will undergo consolidation treatment, and an optional allogeneic hematopoietic stem cell transplantation and post-transplantation maintenance treatment with induction therapy according to patient's wishes.

Eligibility Criteria:
Inclusion Criteria:

1. Newly diagnosed Ph-positive ALL without the history of chemotherapy or target therapy.
2. Age ≥18.
3. Eastern Cooperative Oncology Group (ECOG) score: 0-3.
4. Total serum bilirubin ≤ 2 x upper limit of normal (ULN), alanine aminotransferase (ALT) ≤ 1.5 x ULN, aspartate aminotransferase (AST) ≤ 1.5 x ULN.
5. Creatinine clearance ≥ 30 mL/min.
6. Serum lipase ≤ 1.5 x ULN, amylase =\< 1.5 x ULN.
7. Provide informed consent.

Exclusion Criteria:

1. Patients with another malignant disease.
2. Patients with uncontrolled active infection.
3. Patients with left ventricular ejection fraction \< 0.5 by echocardiography or grade III/IV cardiovascular dysfunction according to the New York Heart Association Classification.
4. Patients with HIV infection, active tuberculosis infection, or active hepatitis B or hepatitis C infection.
5. Patients with uncontrolled active bleeding.
6. Patients who has participated or participating in other clinical trials related to this disease.
7. Patients with history of previous chemotherapy or target therapy (except for oral hydroxyurea and/or leukopheresis for lowering white blood cell counts).
8. Pregnant and lactating women; patients of childbearing potential should be willing to practice methods of contraception throughout the study period.
9. Patients with other commodities that the investigators considered not suitable for the enrollment.
Cohort Study of Bowel Function Following Robotic-assisted Laparoscopic Sacrocolpopexy

Compare changes in bowel function before, 6 months and one year after Robotic-assisted laparoscopic sacral colpopexy. Compare objective anatomic outcomes before, 6 months and one year after Robotic-assisted laparoscopic sacral colpopexy.


Eligibility Criteria:
Inclusion Criteria:

* All patients who underwent robotic assisted laparoscopic sacral colpopexy

Exclusion Criteria:

* Any other procedure for the treatment of pelvic organ prolapse
Effect of Cranberry and Agaves Extract on Microbiota and Intestinal Health

The growing prevalence of obesity and type 2 diabetes (T2D) is a major public health problem. Recent studies have clearly established that the gut microbiota plays a key role in the investigator's propensity to develop obesity and associated metabolic health disorders. The gut microbiota compositions plays a decisive role in glucose metabolism and the chronic inflammatory state associated with insulin resistance. Consuming prebiotic rich diet, including polyphenol and inulin rich food could help modulate favorably the gut microbiota which could lead to a reduction of endotoxemia and beneficial metabolic health effects.

It is now recognized that overweight individuals have altered microbiota which could lead to intestinal barrier defects and chronic inflammation disorders. Polyphenols such as Proanthocyanidins may modulate the gut microbiota thereby providing beneficial effects on metabolic health. Inulin is a well known prebiotic that could stimulate growth of favorable bacteria in the gut.

The overall goal is to determine the efficacy and synergy of a supplement of polyphenols from cranberry extract with or without a supplement of inulin from agaves to reduce chronic inflammation and endotoxemia and to improve glucose metabolism and insulin sensitivity by modulating microbiota of overweight human subjects with metabolic syndrome symptoms.

Eligibility Criteria:
Inclusion Criteria:

* overweight (BMI 25-39.9 kg/m2) or waist circumference ≥ 80 cm (women) and ≥94 cm (men)
* fasting insulin over 60 pmol/L or fasting glucose 5.6 - 6.9 mmol/L
* at least one of the following criteria: Tg ≥ 1.7 mmol/L; blood pressure ≥ 130/85 mmHg; HDL \< 0,9 mmol/L; hsCRP 1-10 mg/L
* non-smoking
* eating fruits and vegetables less then 5 portions/day

Exclusion Criteria:

* chronic disease
* taking drugs or natural health products that could affect glucose or lipid metabolism
* taking anti-inflammatory, antiacids
* taking pre or probiotics
* inflammatory bowel disease
* antibiotics in the past 3 months
* allergy or intolerance to cranberries or agaves
* Major surgery in the past 3 months
Indacaterol Delivered Via a Single Dose Dry Powder Inhaler (SDDPI) in Chronic Obstructive Pulmonary Disease (COPD)

The study is designed to obtain safety and efficacy data on three dose levels of indacaterol when delivered via an SDDPI in patients with COPD. All patients will receive 1 day of treatment with each of the following: indacaterol 150 µg, once- indacaterol 300 µg, indacaterol 600 µg, placebo, and formoterol. Each treatment day will be followed by a washout-period of 1 week.


Eligibility Criteria:
Inclusion Criteria:

* Male and females aged 40-75 years with COPD and symptoms such as cough, sputum production, and shortness of breath.
* Smoking history of at least 10 pack years
* FEV1 less than 65% of the predicted normal value and at least 0.75 L
* Pre-bronchodilator FEV1/FVC less than 70%

Exclusion Criteria:

* A history of asthma or COPD diagnosis before the age of 40
* Hospitalization for COPD exacerbation within the previous 6 weeks
* Respiratory tract infection within 6 weeks
* Use of long-term oxygen therapy
* Diabetes type I or uncontrolled diabetes type II
* Clinically relevant laboratory abnormality or clinically significant condition
* Corrected QT interval (QTc) above 430 ms for males and 450 ms for females, or a history of QTc prolongation. Other protocol-defined inclusion/exclusion criteria may apply.
Exercise-Induced Metabolic Compensation; a Physiological Adaptive Response to Exercise Training

The primary aim of this proposal is to identify changes in the volume of highly metabolic organs (liver, kidneys, and brain) that occur as a physiological adaptation to exercise training and lower the resting energy expenditure. Secondary aims are to identify changes in the metabolic efficiency of muscle in low levels of physical activity and evaluate the effects on components of total daily energy expenditure including the sleeping metabolic rate (SMR) and diet induced thermogenesis (DIT).

Using a clinical trial type protocol, 16 overweight (body mass index: 25-30 kg/m2) men (n=8) and women (n=8) aged 21 to 45 years will exercise for 3 months in a moderate intensity regimen of 20 kcal/week/kg body weight that reflects current recommendations for weight management. The volume of various organs will be measured pre- and post-exercise intervention using magnetic resonance imaging (MRI). A cycling ergometer with a varied workload will be used to assess muscle metabolic efficiency. Changes in overnight SMR and 4 hours post breakfast DIT will be evaluated by whole human room indirect calorimetry ("metabolic chamber"). In addition, free-living Total Energy Expenditure (TEE) will be measured for ten days pre- and post-intervention by doubly labeled water.

Eligibility Criteria:
Inclusion Criteria:

Overweight \[body mass index (BMI) 25-30

Exclusion Criteria:

* Participation in another exercise or weight loss program in the last 6 months
* Non-stable weight (\>±5%) over the past 6 months
* Current regular exercise \> 1 hour per week
* Smoking within the past 6 months
* Being post-menopausal, breastfeeding, pregnancy, or having been pregnant within the past 6 months
* Previous bariatric surgery
* Cardiopulmonary disease (e.g., recent myocardial infarction or unstable angina)
* Musculoskeletal or neuromuscular impairments that preclude exercise training
* Having other health issues include cancer, diabetes, thyroid disease, hypertension, chronic renal failure, cognitive impairments
* Use of drugs that potentially impact body metabolism.
Randomised Controlled Study on the Use of Psychoeducation for Bulimia Nervosa in Young Women

The purpose of this study is to evaluate the effectivity of guided self-help via Internet and bibliotherapy in the treatment of bulimia nervosa (BN) in young women.

Eating disorders and especially bulimia nervosa are psychiatric diseases, affecting 2-4% of women. An intervention such as guided self-help via manuals (bibliotherapy) is a well accepted approach and accepted. Development of new technologies in recent years allows delivery of psychotherapy via CD-ROMs and web-based interfaces. These new technologies have not yet been implemented in Austria in treating bulimia nervosa (BN) patients. In particular patients will be involved, who would not attend medical care regularly. The aim of our study is therefore to deliver guided self-help via an internet platform (supported by email contacts) for 100 patients with BN and to investigate the practicability and effectivity of this approach as well as compliance of patients in this group.

Patients will be found and contacted via internet, get specialized medical investigations, medical care and support via emails. As control group 100 patients with bulimia are treated with bibliotherapy only. Beside effectivity, predictors of outcome (clinical, comorbidity, indication to change, personality) are investigated.

The proposed study is a randomised controlled trial for effectivity and practicability of new technologies in psychiatric treatment research.

This is not a psychotherapy study but a study on psychoeducation, an approach which offers new and helpful opportunities for this patient group.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of bulimia nervosa purging-type
* BMI \> 18 or age corresponding BMI in patients younger than 18y.
* Access to Internet available

Exclusion Criteria:

* Severe depression, alcohol- or drug abuse
* acute suicidality
Laser Light Cues for Gait Freezing in Parkinson's Disease

The purpose of this study is to gather data to see if the Laser Cane and/or U-Step Walker with laser accessory is more effective in aiding with gait freezing than a regular cane/U-Step Walker in patients who have idiopathic Parkinson's disease.

Freezing of gait is a significant clinical problem in Parkinson's disease (PD). It interferes with daily functioning and quality of life and often results in falls that potentially can inflict serious injury. In recent years, much more attention has been focused on the clinical characteristics of gait freezing, the severity of falls that can result, and the use of visual cues as a possible treatment in order to understand the implications of episodic freezing. Few clinical studies have been done to confirm the clinical observations to date. The laser cane is a device that has been used and prescribed in movement disorder centers as the only form of treatment for freezing of gait. Although it has been shown to be effective in many cases, there is no published data to support what has been observed in the clinic. The proposed study seeks to clarify unanswered questions regarding the laser cane and its efficacy in aiding with episodic gait freezing and falls.

Eligibility Criteria:
Inclusion Criteria:

* Subjects or a designated proxy have given informed consent
* Subject has been diagnosed with idiopathic Parkinson's disease
* Subject is ambulatory. If a wheelchair is used part-time, it must be used for less than 50% of the time
* Positive assessment for Questionnaire Used to Identify Freezing of Gait in PD Patients at subject's best "on"

Exclusion Criteria:

* Presence of atypical features suggestive of MSA, PSP, ataxia, unexplained or prominent pyramidal signs, and/or autonomic dysfunction
* Subjects who are non-ambulatory more than 50% of the time
* Subjects who have had a history of syncope in the 6 months prior to screening
* Subjects with moderate or advanced dementia