cyrilzakka/clinical-trials huggingface dataset:
High Intensity Interval Training (HIT) in Patients With Type 2 Diabetes

The purpose of this study is to determine the effect of High Intensity Interval Training (HIT) on insulin sensitivity in skeletal muscle in patients with type 2 diabetes.

Physical exercise increases insulin sensitivity in skeletal muscle in healthy as well as in individuals with type 2 diabetes, but implies a considerable time commitment. High intensity interval training (HIT) is time-efficient exercise consisting of repeated bouts of short duration high intensive workloads. The aim of this study is to determine the effect of HIT in patients with type 2 diabetes, and to clarify the mechanisms of a possible positive effect of HIT.

Exercise is performed as 2 weeks one-legged training on an ergometer bicycle. Thus one leg serves as a control leg. Insulin sensitivity in trained and non-trained muscle will be measured after completion of the overall training program by euglycemic hyperinsulinemic clamp method and a-v catheterization of both legs. Muscle biopsies will be obtained during training period for measuring of muscle glycogen content, and muscle biopsies for further analysis obtained during the experimental day.

Eligibility Criteria:
Inclusion Criteria:

* 10 subjects with Type 2 diabetes. 10 healthy control subjects.
* BMI 28-35
* diet or tablet treatment for diabetes

Exclusion Criteria:

* regular physical activity
* diseases other than type 2 diabetes
* insulin treatment
Buccal and Palatal Bone Thickness and Marginal Bone Changes Implants

The primary outcome of the study was the vertical variation of peri-implant buccal and palatal bone level from implant placement (T0) to uncovering stage (3 months later - T1)

despite various recommendations, there is insufficient evidence to set a threshold for minimal buccal bone thickness necessary to ensure peri-implant marginal bone stability and optimal aesthetic outcomes.

Therefore, the aim of the present multi-centre prospective study was to investigate the influence of buccal and palatal bone thickness at the time of implant placement on peri-implant bone remodeling during the submerged healing period, with a strict control of possible confounding factors.

Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years;
* no smokers;
* no history of periodontal disease;
* healed bone crest (at least six months after tooth extraction);
* crestal bone height ≥8 mm;
* crestal bone with a minimum bucco-palatal width of 6 mm with no concomitant or previous bone augmentation procedures.

Exclusion Criteria:

* absolute contraindications to implant surgery
* immunological or genetic disorders;
* uncontrolled diabetes (HBA1c \> 7.5%);
* present or past treatment with anti resorptive drugs;
* oncologic patients;
* history of head or neck radiotherapy;
* alcohol or drugs abuse;
* final insertion torque \> 50 Ncm.
TAP-patients With Robotic Assisted Lap Prostatectomy

The purpose of the study is to assess the safety and efficacy of EXPAREL when administered via infiltration into the transversus abdominis plane (TAP) to prolonged postsurgical analgesia in men undergoing robot-assisted laparoscopic prostatectomy.

Assess the safety and efficacy of EXPAREL when administered via infiltration into the transversus abdominis plane (TAP) to provide prolonged postsurgical analgesia in men undergoing robot-assisted laparoscopic prostatectomy. The primary endpoint is the duration of abdominal analgesia from the infiltration into the TAP as measured by the time to the subject's first postsurgical opioid administration.

Eligibility Criteria:
Inclusion Criteria:

* male subjects, aged 18-75.
* American Society of Anesthesiology (ASA) physical status 1-3.
* Undergoing robot-assisted laparoscopic prostatectomy performed by a single surgeon (Ingolf Tuerk, MD).
* Subjects must be physically and mentally able to participate in the study and complete all study assessments.
* Subjects must be able to give fully informed consent to participate in this study after demonstrating a good understanding of the risks and benefits of the TAP infiltration.

Exclusion Criteria:

* Demonstrated hypersensitivity or idiosyncratic reactions to amide-type local anesthetics.
* Inability to tolerate oxycodone with acetaminophen (e.g. Percocet).
* Any subject whose anatomy or surgical procedure in the opinion of the Investigator might preclude the potential successful performance of a TAP.
* Any subject who in the opinion of the Investigator might be harmed or be a poor candidate for participation in the study.
* Subjects who have received any investigational drug within 30 days prior to study drug administration or planned administration of another investigational product or procedure during their participation in this study.
Central Line Placement-EVALUATION OF LINE DEPTH AS A FACTOR IN NEED FOR LINE REPLACEMENT SECONDARY TO MALPOSITION

This is a single center, randomized, controlled trial in which tunneled central line catheters will be placed in two distinct, select positions. The catheter tip position will then be followed up prospectively after placement to determine whether there is any malpositioning of the tip and if one placement is better than the other.

Optimal central line placement is vital to catheter longevity. If malpositioned, the catheter may need to get replaced, potentially causing additional morbidity to the patient and additional cost to the healthcare system. In our department, a retrospective study looking at catheter tip position at inital placement and incidence of malposition. In this study, 404 catheter placements were reviewed, and a total of 162 (40.1%) were replaced. Out of the 162 replaced, 36 (22.2%) were replaced secondary to malposition. From this study, we were also able to conclude that catheter tips placed in a deeper position, approximately one and a half vertebral bodies below the carina, were less likely to be malpositioned in the future upon radiographic review.

Current standard of care does not dictate positioning of the line in a specific loacation. In the presence of these findings, we are proposing to conduct a single center randomized control trial in which tunneled central line catheters will be placed in two distinct, select positions. After informed consent is obtained from the patient and family, they will be randomized to one of two treatment groups. The shallow group will have the tip of the catheter located approximately one vertebral body above the carina. The deep group will have the catheter tip placed 1.5 to 2.5 vertebral bodies below the carina. Central line placement will be performed under fluoroscopy in the operating room to optimize catheter placement. Chest X ray in the post operative area will be used to confirm catheter tip position. The catheter tip position will then be followed up prospectively using chest X ray films at or within three months after placement to determine whether there is any malpositioning of the tip.

Eligibility Criteria:
Inclusion Criteria:

* Children from 0-18 years of age needing a tunneled central line (port or broviac) for treatment of their disease.

Exclusion Criteria:

* Wire exchanged lines
* Non ultrasound placed lines, femoral lines, saphenous vein lines, and cut downs
* Short gut syndrome children \< 1 year of age
A Study to Investigate the Efficacy and Safety of Bemdaneprocel in Adults Who Have Parkinson's Disease

Study BRT-DA01-301 is a Phase 3 multicenter, randomized, sham surgery-controlled, double-blind study to assess efficacy and safety of bemdaneprocel in approximately 102 adults with Parkinson's Disease (PD).

The BRT-DA01-301 study is a Phase 3, multicenter, randomized, sham surgery-controlled, double-blind study involving approximately 102 participants with Parkinson's Disease (PD). Participants will be randomized in a 2:1 ratio to either receive bemdaneprocel or undergo sham surgery. The study includes an immunosuppression regimen and placebo equivalents to maintain blinding. The primary objective is to evaluate the efficacy of bemdaneprocel on motor symptoms in participants with PD. The secondary objective is to evaluate the effects of bemdaneprocel on Motor function, Quality of life, Non-motor symptoms of PD, Disease severity, and Use of PD medications or therapies compared with participants who undergo sham surgery. Participants will be followed for at least 18 months in the double-blind period and up to five years if they receive bemdaneprocel.

Eligibility Criteria:
Inclusion Criteria:

1. Individual of any sex ≥45 to ≤75 years of age at informed consent
2. Diagnosis of clinically established PD
3. ≥4 and \<12 years from time of PD diagnosis at informed consent
4. Must demonstrate responsiveness to levodopa therapy
5. Receiving medical therapy for the treatment of PD symptoms
6. ≥2.5 hours of daily OFF-time

Exclusion Criteria:

1. PD presenting with recurrent falls
2. Diagnosis of primary mitochondrial disorder, epilepsy, stroke, multiple sclerosis, or clinical features suggestive of a neurodegenerative disease other than PD, including multiple system atrophy, progressive supranuclear palsy, corticobasal degeneration, or Lewy body dementia
3. Any current or relevant previous history of serious, severe, or unstable physical, neurological, or psychiatric illness that may interfere with study participation, participant's safety, or assessment of endpoints per investigator's judgment
4. History of gene therapy or cell therapy
5. Prior surgical or radiation therapy to the brain, including deep brain stimulation (DBS) and lesion therapy, or prior history of intradural spinal cord surgery
6. Contraindication to surgery, general anesthesia, cell therapy, immunosuppression, or other required drugs
7. Current or previously active malignant disease within the past 5 years
8. Chronic immunosuppressive therapy
9. Receipt of another investigational therapy
10. Pregnancy or breastfeeding
Effects of Exosome Adminstration in Preventing Early Leakage in Rectal Cancer Patients Undergoing Low Anterior Resection

The goal of this clinical trial is to assess the safety and efficacy of Human Placenta Mesenchymal Stem Cells Derived Exosomes in preventing early anastomosis leak in patients undergoing low anterior resection for rectal cancer. The main question it aims to answer are

Do Mesenchymal Stem Cell-Derived Exosomes prevent early anastomosis leak in patients undergoing low anterior resection for rectal cancer?

If there is a comparison group: Researchers will compare Mesenchymal Stem Cells Derived Exosomes to placebo to see if it can prevent early anastomotic leakage.

Participants will receive intraperitoneal Mesenchymal Stem Cells Derived Exosomes at the end of their surgery.

Anastomotic leakage remains one of the most severe complications following colorectal surgery, leading to increased morbidity, prolonged hospitalization, and reduced quality of life. Despite advances in surgical techniques and perioperative care, the incidence of early anastomotic leaks persists. Practical strategies to reduce this risk are crucial for improving patient outcomes.

Recent studies have highlighted the potential role of mesenchymal stem cell-derived exosomes in enhancing tissue repair and modulating inflammation. These extracellular vesicles, derived from human placenta mesenchymal stem cells (hPMSC), contain bioactive molecules such as proteins, lipids, and RNA that facilitate cellular communication and promote healing processes. Preclinical research suggests that exosomes can support anastomotic healing by reducing local inflammation.

This study aims to evaluate the safety and efficacy of intraperitoneal administration of hPMSC-derived exosomes in preventing early anastomotic leakage in patients undergoing low anterior resection (LAR) for rectal cancer. We hypothesize that the exosome treatment will significantly reduce the incidence of anastomotic leaks compared to placebo, thereby improving postoperative recovery and reducing hospital stay.

Eligibility Criteria:
Inclusion Criteria:

-Patients with Stage II-III rectal cancer who underwent neoadjuvant chemoradiation therapy and are candidates for low anterior resection surgery

Exclusion Criteria:

* Patients who need emergency surgery (presenting with peritonitis or signs of obstruction)
* Patients with apparent malnutrition or patients who have serum albumin levels of less than 3 g/dl
* Patients who receive corticosteroids ( an equivalent dose of prednisolone 5 mg/day or more)
* Patients with chronic pulmonary disease
* Patients who need more than two units of blood transfusion perioperatively
Diabetic Foot Ulcers-Comparing Transforming Powder to Standard of Care

Phase IV, randomized, prospective, multi-center, open-label, comparison of transforming powder dressing to standard of care dressing for healing diabetic foot ulcers.

Diabetic men and women aged 18-89 years, who have a diabetic foot ulcer present for a minimum of 30 days will be considered for the study. Subjects will be randomized to either standard of care wound dressings or transforming powder dressing. Half of the subjects will receive standard of care dressings, and the other half will receive transforming powder dressing in a 1:1 randomization process at each of the study sites. Subjects will present to the study center weekly for up to 12 weeks (less time if the wound heals prior to 12 weeks). The last study visit occurs 12 weeks after the End of Study visit.

Eligibility Criteria:
Inclusion Criteria:

* 18-89 years old
* Diagnosed with diabetes Mellitus; hemoglobin A1C \< 12%
* Diabetic foot ulcer present for minimum 30 days (Wagner grade 1 or 2 classification)
* Wound drainage is minimal or moderate
* No clinically active wound infection
* Able and willing to provide consent
* Has not participated in another research trial within 3 months of enrollment.

Exclusion Criteria:

* Unable to keep weekly research appointments
* Unable or unwilling to use offloading device if recommended
* Wounds with large amount (high) drainage
* Active gangrene
* Wounds impending surgical intervention (including revascularization or plastic surgery)
* Untreated osteomyelitis
* Soft tissue infection (can be enrolled once infection is cleared)
* Active Charcot arthropathy
* BMI \>45kg/m2
* History of AIDS
* History of organ transplant or impending transplant
* End stage renal disease requiring dialysis
* Decompensated hepatic or cardiac disease
* Select autoimmune diseases
* Lymphedema
* Oral steroid use in last 3 months
* Venous stasis disease
* Active malignancy (cancer)
* Unable to sign consent
* Active alcohol or substance abuse
* Pregnant or lactating women
* Insufficient vascular flow to heal a wound
* Hemoglobin A1C \>12%
Cognitive Outcome After SRS or WBRT in Patients With Multiple Brain Metastases (CAR-Study B)

Whole Brain Radiation Therapy (WBRT) has long been the mainstay of treatment for patients with multiple brain metastases (BM). Meanwhile, Gamma Knife radiosurgery (GKRS) has been increasingly employed in the management of multiple BM to spare healthy tissue. Hence, GKRS is expected to cause fewer cognitive side effects than WBRT. Treatment of multiple BM without cognitive side effects is becoming more important, as more patients live longer due to better systemic treatment options. There are no published randomized trials yet directly comparing GKRS to WBRT in patients with multiple BM, including objective neuropsychological testing.

CAR-Study B is a prospective randomized trial comparing cognitive outcome after GKRS or WBRT in eligible patients with 11-20 BM.

CAR-Study B is a prospective randomized trial comparing cognitive outcome after GKRS or WBRT in eligible patients with 11-20 BM on a triple dose gadolinium-enhanced MRI-scan. Neuropsychological assessment will be performed at baseline and at 3, 6, 9, 12 and 15 months after treatment. Follow-up assessments will be combined with 3-monthly MRI-scans.

Patients will be randomized to either GKRS or WBRT. Groups will be balanced at baseline (prior to radiotherapy), taking into account several (stratification) factors that may influence cognitive functioning over time, such as: total tumor volume in the brain, systemic treatment, KPS, age, histology, and baseline HVLT-R total recall score.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven malignant cancer
* 11-20 newly diagnosed brain metastases on a triple dose gadolinium-enhanced MRI-scan
* Maximum total tumor volume ≤ 30 cm3
* Lesion ≥ 3 mm from the optic apparatus
* Age ≥ 18 years
* Karnofsky Performance Status (KPS) ≥ 70
* Anticipated survival \> 3 months

Exclusion Criteria:

* No prior histologic confirmation of malignancy
* Primary brain tumor
* A second active primary tumor
* Small cell lung cancer (SCLC)
* Lymphoma
* Leukemia
* Meningeal disease
* Progressive, symptomatic systemic disease without further treatment options
* Prior brain radiation
* Prior surgical resection of BM
* Cardiovascular accident (CVA) \< 2 years ago
* Additional history of a significant neurological or psychiatric disorder
* Contra indications to MRI or gadolinium contrast
* Underlying medical condition precluding adequate follow-up
* Participation in a concurrent study in which neuropsychological testing and/or health-related QOL assessments are involved
* Lack of basic proficiency in Dutch
* IQ below 85
* Severe aphasia
* Paralysis grade 0-3 according to MRC scale (Medical Research Council)
Pulmonary Rehabilitation Through Tele Rehabilitation for COPD in Pakistan

To determine the feasibility of Tele-rehabilitation vs traditional center-based pulmonary rehabilitation for people with chronic obstructive pulmonary disease


Eligibility Criteria:
Inclusion Criteria:

* have a primary diagnosis of a chronic obstructive pulmonary disease
* aged ≥40 years
* be able to read and speak Urdu
* Vitally stable
* both gender

Exclusion Criteria:

* Inability to use technology, inadequate home setting, and patient's refusal.
* pulmonary hypertension or lung cancer attended pulmonary rehabilitation within the previous 18 months and had no hospitalizations for a respiratory cause since rehabilitation completion
* oxygen desaturation resulting in cessation of cardiopulmonary exercise testing (e.g. SpO2 \&lt; 80% during exercise on cycle ergometer)
* to ensure safety of unsupervised training
* unstable or brittle asthma with a hospital admission or emergency department presentation within the preceding 3 months, to ensure safety of unsupervised training
* co-morbidities which preclude exercise training, such as neurological or musculoskeletal impairment
* unable to follow verbal instructions, suffer from cognitive impairment, or have language difficulties
Proprotein Convertase Subtilisin Kexin 9 in Rheumatoid Arthritis

Rheumatoid arthritis (RA) has been proved to increase the incidence of atrial fibrillation (AF) with persistent systemic inflammation. Proprotein convertase subtilisin/kexin type 9 (PCSK9) has been found to enhance the production of pro-inflammatory cytokines. Therefore, we performed the present study to observe the expression and significance of proprotein convertase subtilisin kexin 9 (PCSK9) in patients with RA combined atrial fibrillation.

Atrial fibrillation (AF), the most common clinically relevant arrhythmia, is an important contributor to population morbidity and mortality. Rheumatoid arthritis (RA) is a chronic systemic inflammatory disease, which affects approximately 1% of the population. Increasing studies demonstrated that RA had a positive correlation with increased cardiovascular diseases. Increasing studies showed that the prevalence of AF is significantly higher in RA patients than in the general population. Recently, some studies indicated that proprotein convertase subtilisin/kexin type 9 (PCSK9) promotes inflammatory by regulating macrophage secretion of inflammatory cytokines, inducing C-reaction protein (CRP), interleukin (IL)-6, IL-8, tumor necrosis factor-α (TNF-α) and so on. However, the levels of PCSK9 in atrial fibrillation patients with rheumatoid arthritis is still unclear. Therefore, the aim of this study was to assess the expression of PCSK9 in patients with RA combined atrial fibrillation.

Eligibility Criteria:
Inclusion Criteria:

1. Rheumatoid arthritis
2. Rheumatoid arthritis combined with AF

Exclusion Criteria:

1. (1) History of hypertension, diabetes, cardiovascular disease, severe impairment of liver function, severe renal insufficiency.

(2) Infectious diseases. (3) History malignant tumor. (4) Pregnant women, Lactating women. (5) Other autoimmune diseases.

2. (1) History of hypertension, diabetes, cardiovascular disease (except for AF), severe impairment of liver function, severe renal insufficiency.

(2) Infectious diseases. (3) History malignant tumor. (4) Pregnant women, Lactating women. (5) Other autoimmune diseases.
Tocladesine in Treating Patients With Recurrent or Refractory Multiple Myeloma

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of tocladesine in treating patients who have recurrent or refractory multiple myeloma.

OBJECTIVES: I. Determine the safety of 8-chloro-cyclic adenosine monophosphate (8-chloro-cAMP) in patients with recurrent or refractory multiple myeloma. II. Evaluate the efficacy of this regimen in these patients. III. Determine the pharmacokinetics of this regimen in these patients.

OUTLINE: Patients receive 8-chloro-cyclic adenosine monophosphate (8-chloro-cAMP) over 120 hours every 2 weeks for up to 4 courses. Beginning with course 5, patients with stable or responsive disease receive 8-chloro-cAMP over 120 hours every 3 weeks until disease progression. Patients are followed every 3 months until death.

PROJECTED ACCRUAL: A maximum of 29 patients will be accrued for this study within 12-18 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed recurrent or refractory multiple myeloma Measurable disease by monoclonal serum or urine globulins OR Malignant plasma cells documented on bilateral bone marrow biopsy Refractory after at least one prior therapeutic regimen (no more than 2 prior regimens allowed)

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Creatinine no greater than 1.5 mg/dL AND/OR Creatinine clearance at least 60 mL/min Calcium no greater than 8.7 g/dL Cardiovascular: No history of arrhythmias No uncontrolled angina pectoris No symptomatic coronary ischemia No grade 3 or 4 congestive heart failure Cardiac ejection fraction greater than 35% by gated imaging Other: Not pregnant or nursing Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 3 weeks since prior chemotherapy Endocrine therapy: At least 3 weeks since prior glucocorticoids Radiotherapy: Not specified Surgery: Not specified Other: No concurrent theophylline therapy