cyrilzakka/clinical-trials huggingface dataset:
The Impact of Functional Exercise Training on Postoperative Knee Joint Recovery in Patients with Meniscal Injury

AIM: To investigate the impact of functional exercise training on postoperative functional recovery in patients with knee meniscus injuries.

METHODS:A prospective randomized controlled trial (RCT) was conducted from April 2023 to September 2024, involving 96 patients with knee meniscus injuries who underwent meniscus repair interventions. Participants were randomly assigned to either the Control （CON） group (n=48) or the functional exercise training (FET) group (n=48) using a computer-generated random number table. The CON group received standard rehabilitation, while the FET group underwent functional exercise training. Clinical outcomes were evaluated at baseline, 1 month, and 6 months post-intervention, including the Lysholm score, IKDC score, VAS pain score, range of motion (ROM), serum levels of prostaglandin E2 (PGE2) and serotonin (5-HT), as well as passive 60° position sense and 60° motion sense. Postoperative complications occurring within 1 month were also recorded.


Eligibility Criteria:
Inclusion Criteria:

* meniscus injury was diagnosed by magnetic resonance imaging; meniscoplasty was performed; No shedding occurred during follow-up.

Exclusion Criteria:

* Patients with joint dislocation and fracture; poor compliance; severe osteoarthritis, rheumatoid arthritis; Combined with metabolic diseases, coagulation disorders and serious organic diseases.
Lifestyle Program (Scalable Nutrition and Physical Activity) for the Improvement of Nutrition and Physical Activity in Stage 0-III Breast Cancer Survivors

The purpose of this phase II trial is to identify the most effective dose level (number of classes) of a diet and physical activity lifestyle program based on how well it improves diet and physical activity in stage 0-III breast cancer survivors. Study results may provide researchers with information on how to best implement diet and physical activity recommendations among breast cancer survivors.

OUTLINE: Participants are randomized to 1 of 2 arms.

ARM A (LOW DOSE): Participants attend one diet and physical activity class delivered remotely via Zoom and receive an eHealth communication intervention for 6 months.

ARM B (HIGH DOSE): Participants attend 12 twice monthly diet and physical activity online sessions delivered remotely via Zoom and receive an eHealth communication intervention for 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Previous diagnosis of stage 0-III breast cancer in the past 10 years at the time of enrollment
* No evidence of recurrent or metastatic disease
* No uncontrolled diabetes mellitus defined as glycosylated hemoglobin (Hgb A1C) \> 8%
* No uncontrolled hypertension per Seattle Cancer Care Alliance (SCCA) standard of care
* At least 60 days post final chemotherapy, biologic therapy, or radiation therapy and/or surgery. Current use of endocrine therapy is permitted (e.g., tamoxifen and aromatase inhibitors)
* Access to phone for study contacts
* Access to smartphone, tablet, or computer and internet to attend online session(s) and receive study electronic eHealth communication (text messages and access to website)
* Willing and able to attend the online session(s) on Saturdays, or via online accessed videos, for up to 12 sessions in 6 months
* Successfully complete all run-in activities, including at-home and over the phone assessments, 7 days of collecting physical activity data via accelerometer, and providing blood and stool sample
* Willing and able to complete all study activities for 6 months after randomization
* Participants must consume \< 5 servings of fruits and vegetables per day and/or engage in \< 150 minutes per week of moderate to vigorous physical activity, as assessed by brief questionnaires
* Participants must have an Eastern Cooperative Oncology Group (ECOG) Scale of performance status score of 0 or 1 for performance status.
* Signed physician approval for diet change and physical activity
* Able to understand and willing to sign written informed electronic (e) consent in English

Exclusion Criteria:

* Participants must not be active smokers within the past 30 days.
* Women must not be pregnant at time of enrollment
Investigation of Neuro-hormonal Mechanisms of Hunger, Fullness and Obesity.

The purpose of this study is to determine abnormal neuro-hormonal mechanisms that may impair the ability to feel full and which therefore, may lead to obesity.


Eligibility Criteria:
Inclusion Criteria:

* Males and females 18 to 65 years of age.
* Obese Subjects with BMI \>40.
* Normal weight subjects with BMI = 18.5-24.9

Exclusion Criteria:

* Age younger than 18 years and over 65 years of age.
* Current use of narcotics or morphine
* Previous gastric surgery
* Presence of the following disorders that are known to cause functional gastric stasis syndromes: Diabetes Mellitus, Hypothyroidism, Progressive Systemic Sclerosis, Systemic Lupus Erythematosus, Dermatomyositis, Familial Dysautonomia, Pernicious Anemia, Bulbar poliomyelitis, Amyloidosis, Gastric Ulcer, Post-vagotomy, Tumor-associated gastroparesis, Fabry disease, Myotonic Dystrophy, Post-operative ileus, Gastroenteritis.
* Presence of the following disorders that are known to cause delayed gastric emptying: peptic ulceration, recent surgery, pyloric hypertrophy, post-radiotherapy, ileus, anorexia nervosa, acute viral infections.
* Presence of the following disorders that are known to cause rapid gastric emptying: Pyloroplasty, Hemigastrectomy, Duodenal ulcer, Gastrinoma (Zollinger-Ellison syndrome), Hyperthyroidism
* Current use of Thyroxine as it is known to cause rapid gastric emptying
* Current or recent (within the last 2 weeks) use of anti-spasmodics or pro-kinetic medications.
* Current use of Hyperalimentation
* Presence of any metabolic disorder, such as: hyperglycemia, acidosis, hypokalemia, hypercalcemia, hepatic coma or myxedema.
* Current use of estrogen or progesterone
* Current use of the following drugs that are known to delay gastric emptying: Nifedipine, beta-adrenergic agonists, Isoproterenol, Theophylline, Sucralfate, anticholinergics, Levodopa, diazepam, tricyclic antidepressants, phenothiazine, Progesterone, oral contraceptives, alcohol, nicotine, opiates.
* Allergy to eggs or wheat.
* Pregnancy.
Effects of Caffeine-based Supplement on Physical Performance

The aim of the study was to determine the acute effects of multi-ingredient pre-workout supple-ment (MIPS) containing: beta-alanine, taurine, caffeine, L-tyrosine, and cayenne pepper (capsaicin) on physical performance in untrained men

The aim of our study was to determine the acute effects of commercially available multi-ingredient pre-workout supple-ment (MIPS) containing: beta-alanine, taurine, caffeine, L-tyrosine, and cayenne pepper (capsai-cin) on physical performance in untrained men. The aerobic and anaerobic capacity was determined after ingestion of MIPS. A randomized, crossover, single-blind design was used to evaluate the effects of the dietary supplement on physical performance. The participants performed the exercise test twice, in random order: as a control test and after supplement administration (MIPS). The measurements took place over two consecutive days. Somatic measurements were taken on the same day that the first all-out test was performed. Twelve young healthy men, without medical contraindications to supramaximal and maximal intensity exercise, participated in the study. The exercise tests took place under medical supervision.

Eligibility Criteria:
Inclusion Criteria:

lack of neuromuscular and musculoskeletal disorders; no medication nor dietary supplements used within the previous month which could potentially affect the study outcomes and self-described good health status. An additional inclusion criterion was the small amount of caffeine consumed per day, i.e. only one caffeinated coffee drink per day or less.

Exclusion Criteria:

consumption of energy drinks
Evaluate the Safety, Tolerability and Pharmacokinetics of BG00010 (Neublastin) Administered to Sciatica Participants

The primary objective of the study is to determine the safety/tolerability profile, systemic PK behavior, and immunogenicity of single IV and SC administrations of BG00010 to sciatica participants.


Eligibility Criteria:
Key Inclusion Criteria:

* Must have a diagnosis of unilateral sciatica, determined by the Investigator. Sciatica symptoms must be present for 6 or more weeks prior to the Screening Visit.
* Must have a body mass index (BMI) between 18 kg/m2 and 32 kg/m2.
* Must rate their pain at \>40 mm on the 100 mm Visual Analog Scale (VAS) of the Short-Form McGill Pain Questionnaire (SF-MPQ)at the Screening and Baseline Visits.

Key Exclusion Criteria:

* History of malignancy or clinically significant (as determined by the Investigator) allergies, cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic (not related to sciatica), dermatologic, rheumatic/joint, psychiatric, renal, and/or other major disease.
* History of signs or symptoms of peripheral neuropathy, other than symptoms of sciatica.
* History of severe allergic or anaphylactic drug-related reactions. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Comparison The Postoperative Effects of Local and Systemic Antibiotics Applied With Platelets Rich Fibrin

The aim of this study was investigate the comparison of postoperative effects of local antibiotics mixed with platelet-rich fibrin and postoperative systemic antibiotic applications prescribed for mandibular impacted third molar tooth extraction. The study included a total of 75 patients with impacted mandibular third molar. Patients were evaluated in 5 randomly separated groups. For the first and third group, Platelets Rich Fibrin+ systemic Antibiotics were applied into the tooth socket and for the second and fourth group, Platelets Rich Fibrin + local antibiotics were applied, respectively. There was a control group which only Platelets Rich Fibrin was applied into the socket. The outcome variables were pain, swelling, the number of analgesics taken, and trismus. These variables were also assessed based on first, second, third, and seventh days following the operation.


Eligibility Criteria:
Inclusion Criteria:

* The patient had no systemic diseases, no taken opioids for a long period, no current infections or acute pericoronitis, no smoke or drink alcohol, no pregnancy, the absence of allergy to penicillin and presence of penicillin allergy.

Exclusion Criteria:

* pericoronitis, no inflammation
Incidence of Hypophosphatemia After Treatment With Iron Isomaltoside/Ferric Derisomaltose vs Ferric Carboxymaltose in Subjects With Iron Deficiency Anaemia

The trial was designed to evaluate the incidence of unintended hypophosphatemia (low level of phosphate in the blood) in subjects with iron deficiency anaemia (IDA).

This trial was designed to evaluate the effect of IV iron isomaltoside/ferric derisomaltose compared with IV ferric carboxymaltose on s-phosphate in subjects with IDA caused by different etiologies.

The subjects received either a single intravenous (IV) dose of iron isomaltoside/ferric derisomaltose (1000 mg at baseline) or two IV doses of ferric carboxymaltose (one dose 750 mg at baseline and a second dose 750 mg on day 7; cumulative dose: 1500 mg). The study subjects were monitored for up to 35 days from baseline.

Eligibility Criteria:
Inclusion Criteria include:

* Subjects diagnosed with IDA, caused by different aetiologies
* Haemoglobin (Hb) ≤ 11 g/dL
* Body weight \> 50 kg
* Serum ferritin (S-ferritin) \< 100 ng/mL
* Estimated glomerular filtration rate (eGFR) ≥ 65 mL/min/1.73 m2
* Serum phosphate (S-phosphate) \> 2.5 mg/dL
* Intolerance or unresponsiveness to oral iron
* Willingness to participate and signing the Informed Consent Form (ICF)

Exclusion Criteria include:

* Acute bleeding \> 500 mL within 72 hours
* Anaemia predominantly caused by factors other than IDA
* Hemochromatosis or other iron storage disorders
* Previous serious hypersensitivity reactions to any IV iron compounds
* Treatment with IV iron within the last 30 days prior to screening
* Treatment with erythropoietin or erythropoietin-stimulation agents
* Red blood cell transfusion, radiotherapy, and/or chemotherapy
* Received an investigational drug within the last 30 days prior to screening
* Planned surgical procedure within the trial period
* Hepatic enzymes \> 3 times upper limit of normal
* Surgery under anaesthetic within the last 30 days prior to screening
* Any non-viral infection within the last 30 days prior to screening
* Alcohol or drug abuse within the past 6 months
* Vitamin D deficiency
* Untreated hyperparathyroidism
* Kidney transplantation
* Active malignant disease, disease-free for less than 5 years
* History of a psychological illness or seizures
* Pregnant or nursing women.
Evaluation of Digit Tip and Split Skin Donor Site Transcriptome

Regrowth of amputated fingertips presents a unique regenerative healing process in mammals, with subcutaneous volume regrowth, restoration of the dactylogram, and suppression of scar formation. In addition, wound healing from split-thickness donor sites shows almost scar-free healing. Transcriptome analysis is necessary to better understand the specific healing mechanisms of these two wound entities. Since no data are available to date, this study aims to fill the gap.

Regrowth of amputated fingertips presents a unique regenerative healing process in mammals, with subcutaneous volume regrowth, restoration of the dactylogram, and suppression of scar formation. In addition, wound healing from split-thickness donor sites shows almost scar-free healing. Transcriptome analysis is necessary to better understand the specific healing mechanisms of these two wound entities. Since no data are available to date, this study aims to fill the gap.

Eligibility Criteria:
Inclusion Criteria:

1. Digit Tip Wound: Wound Exudate from healthy patients: Consent-capable patients ≥18 years of age with clean Digit Tip Wound
2. Split Skin Donor Site Wound: Wound Exudate from healthy patients: Consent-capable patients ≥18 years of age with clean Split Skin Donor Site Wound

Exclusion Criteria:

* Inflammation
* Borderline
* Infectious Disease
Single Site Thoracic Surgery for Pediatric Pneumothorax

Video-Assisted Thoracoscopic Surgery (VATS) has become a standard of care in adults, pediatric surgeons have been slower to undertake this approach. There are limitations for working in children. The site of a chest tube becomes the working site for thoracoscopic surgery and the only scar. We propose this study to do a retrospective review comparing the conventional multiport thoracic surgery with the newer single port site.

While Video-Assisted Thoracoscopic Surgery (VATS) has become a standard of care in adults, pediatric surgeons have been slower to undertake this approach. The limitations for working in children are decreased working space, unknown thoracoscopic effects on body physiology, and instrument accommodation. Especially as the field for minimally invasive surgery expands, using the single port approach has unique implications in children. The site of a chest tube becomes the working site for thoracoscopic surgery and the only scar. Despite some learning curve, the preliminary outcomes are similar to the multiport surgeries with better cosmesis. The learning curves for single port site surgery have been well described and our group recently performed a similar study for appendectomies. We propose this study to do a retrospective review comparing the conventional multiport thoracic surgery with the newer single port site.

Eligibility Criteria:
Inclusion Criteria:

* Age \< 19 years old
* pneumothorax
* underwent surgery for pneumothorax

Exclusion Criteria:

* Age =/\> 19 years old
* history of prior thoracic surgery
* history of cancer
A Mobile Mindfulness Programme for Individuals/Couples Experiencing Fertility Problems

Infertility and its treatment result in a considerate emotional burden and a recent guideline of the European Society of Human Reproduction (ESHRE) highlight the importance to support couples facing fertility problems. Mindfulness-based programs (MBPs) have been proven effective in improving well-being and combatting mood disturbances in a wide range of conditions in both treatment and prevention. The overall aim of this project is to evaluate the impact of a mobile mindfulness programme (mMP) on quality of life and emotional well-being in individuals/couples experiencing fertility problems. The present study is a two-group randomized controlled trial with assessments at baseline, at 1,5 months and at 3 months. Sixty couples experiencing fertility problems will be enrolled. They will be assigned to either an intervention group (immediate access to the mMP) or a control group (waitlist condition). The mobile MBP is developed by a team of experienced mindfulness trainers, clinical psychologists, and a psychiatrist and adheres to a standardized protocol. The primary outcomes will be quality of life and emotional distress. Secondary outcomes will be repetitive negative thinking, self-compassion and mindfulness skills. Additionally, the feasibility of the mMP will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Individuals/couples experiencing fertility problems (using the criteria for the definition of 'infertility', as in: the failure to achieve a clinical pregnancy after 12 months or more of regular unprotected sexual intercourse) (Zegers-Hochschild et al., 2017)
* Both partners possess a smartphone
* Both partners understand and speak Dutch
* Written informed consent after been informed on all aspects of the study

Exclusion Criteria:

Not applicable
Safety Evaluation of 3K3A-APC in Ischemic Stroke

The purpose of this study was to evaluate the safety, pharmacokinetics (PK) and preliminary efficacy of multiple ascending intravenous doses of 3K3A-APC, a Recombinant Variant of Human activated protein C (APC), in in the treatment of acute ischemic stroke following treatment with recombinant tissue plasminogen activator (tPA), mechanical thrombectomy or both.

This was a multicenter, prospective, randomized, controlled, double-blinded Phase 2 study intended to evaluate the safety, PK and preliminary efficacy of 3K3A-APC following treatment with tPA, mechanical thrombectomy or both in subjects with moderate to severe acute ischemic stroke.

Approximately 115 subjects were to be randomized, which included the planned 88 subjects in groups of 4 subjects to either 3K3A-APC or placebo (in a 3:1 ratio) and the additional placebo subjects who were enrolled during safety review pauses. This study used a modified version of the continual reassessment method (CRM) in order to establish a maximum tolerated dose (MTD).

Eligible subjects received 3K3A-APC or placebo every 12 hours for up to 5 doses (approximately 3 days), or until discharge from the hospital, whichever occurred first. Subjects were monitored for safety evaluations through Day 7 (or discharge, if earlier) and were expected to be seen on Day 7, 14, 30, and 90 for safety and outcome evaluations.

Eligibility Criteria:
Inclusion Criteria:

* Acute ischemic stroke
* Able to receive IV tPA, mechanical thrombectomy or both
* National Institutes of Health Stroke Scale (NIHSS) score of ≥ 5
* Signed informed consent
* Mechanical thrombectomy subjects only: onset time to arterial puncture time \< 6 hours

Exclusion Criteria:

* History of stroke or penetrating head injury within 90 days prior to enrollment
* History of previous or current diagnosis of intracranial hemorrhage that represents a potential for re-hemorrhage if subjected to thrombolytic therapy or mechanical thrombectomy
* Moyamoya disease, cerebral arterio-venous malformation (AVM), known unsecured aneurysm requiring intervention during the acute study period
* Presence of other neurological or non-neurological co-morbidities that may lead, independently of the current stroke, to further deterioration in the subject's neurological status during the trial period
* Presence of premorbid neurological deficits and functional limitations assessed by a retrospective Modified Rankin Scale (mRS) score of ≥ 2
* Mechanical thrombectomy subjects only: baseline non-contrast CT scan revealing a large core occlusion as defined by local protocol
* Prolonged prothrombin time (PT) or activated partial thromboplastin time (aPTT)
* Severe hypertension or hypotension
* Glomerular filtration rate (GFR) \<35 mL/min
* Blood glucose concentration \< 50 mg/dL
* Prior exposure to any exogenous form of APC
Paclitaxel and Bryostatin 1 in Treating Patients With Advanced Pancreatic Cancer

Phase II trial to study the effectiveness of combining paclitaxel and bryostatin-1 in treating patients who have locally advanced unresectable or metastatic pancreatic cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Bryostatin-1 may help paclitaxel kill more cancer cells by making tumor cells more sensitive to the drug.

PRIMARY OBJECTIVES:

I. To determine the response rates to weekly, sequential paclitaxel/ bryostatin-1 in patients with unresectable and metastatic pancreatic cancer.

II. To determine the toxicity of therapy. III. To determine patient survival after therapy. IV. To determine Bryostatin-1 pharmacokinetics.

OUTLINE: This is an open-label, multicenter study.

Patients receive paclitaxel IV over 1 hour on day 1 followed by bryostatin 1 IV over 1 hour on day 2 of weeks 1-3. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Eligibility Criteria:
Inclusion Criteria:

* Histologic proof of adenocarcinoma of the pancreas that is locally advanced and considered surgically not resectable or metastatic
* Patients with or without prior treatment are eligible for treatment on protocol; prior treatment may have included one treatment course of chemo/RT and/ or one course of chemotherapy, but not two prior courses of chemotherapy;
* Measurable disease
* ECOG performance status of 0-1
* Ability to sign an informed consent form indicating awareness of the investigational nature of this study, in keeping with the policies of the hospital
* Patients may not be receiving any other concurrent chemotherapy, immunotherapy, or radiotherapy; the most recent treatment for pancreatic cancer, within the limitations of allowed prior therapy must be 28 days or longer prior to enrollment on study
* Absolute granulocytes \> 1,500/mm\^3
* Platelets \> 150,000/mm\^3
* Serum bilirubin \< 1.5 mg/dl
* Serum creatinine \< 1.5 mg/dl

Exclusion Criteria:

* Presence of any ongoing toxic effect from prior treatment
* Brain metastases
* History of active angina or myocardial infarction within 6 months; history of significant ventricular arrhythmia requiring medication with antiarrhythmics; well controlled atrial fibrillation on standard management will be permitted
* Pregnant or lactating women
* Pre-existing neurotoxicity that is graded 3+ or greater
* Serious intercurrent infections, or nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the complications of this therapy
* Psychiatric disorders rendering patients incapable of complying with the requirements of the protocol
* HIV infection
* Any other medical condition or reason that, in the investigator's opinion, makes the patient unsuitable to participate in a clinical trial (for example a history of prior poor compliance with treatment)