cyrilzakka/clinical-trials huggingface dataset:
The Safety and Efficacy of Micro-energy Ultrasound in the Treatment of Renal Insufficiency After Renal Transplantation

The safety and efficacy of micro-energy ultrasound in the treatment of renal insufficiency after renal transplantation.

1. Study purposes: To evaluate the safety and efficacy of micro-energy ultrasound in the treatment of renal dysfunction after renal transplantation by measuring serum creatinine, urine volume, urea nitrogen, and transplanted kidney ultrasound, etc.
2. Study design: This is a randomized, double-blind, controlled, multicenter clinical trial.
3. Study objects: Patients with mild to moderate renal insufficiency after renal transplantation.
4. Number of samples: 90
5. Main study center: Department of Urology, The Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, China.
6. Treatments:

Test group: After installing the disposable treatment head coat, the transplanted kidney was treated with an ultrasonic therapeutic apparatus; after the treatment, the disposable treatment head coat was removed.Patients were treated twice a week for 6 weeks.

Control group: The placebo was treated with an ultrasound therapy device and used in the same manner as the test group.

Eligibility Criteria:
Inclusion Criteria:

1. More than half a year after renal transplantation, serum creatinine elevated over three times , patients with ineffective immunosuppressive drugs;
2. Mild to moderate renal insufficiency (creatinine less than 442umol / L);
3. Volunteer to participate in this clinical trial, comply with the requirements of this clinical trial and sign the informed consent form.

Exclusion Criteria:

1. Patients with severe renal insufficiency;
2. Blood routine suggests acute and chronic blood system diseases;
3. B-ultrasound suggests transplanting hydronephrosis;
4. Uncontrollable patients with diabetes, hypertension, and cardiovascular disease;
5. The investigator determined that it is not suitable for this clinical trial.
Is There a Correlation Between Surgical Technique for Primary Anterior Cruciate Ligament Surgery and the Risk of Subsequent Formation of Fibrous Cyst (Cyclops) in the Knee Joint, Which Leads to the Need for Surgical Removal of the Cyclops?

Fibrous scar tissue formation (Cyclops) after a primary anterior cruciate ligament reconstruction (ACLr) may affect patients' ability to perform work and exercise to such an extent that further arthroscopic surgery may be necessary.

The purpose of the study is to estimate the 2-year incidence of removal of cyclops lesion after ACLr for a cohort of approximal 3000 patients operated at Aarhus University Hospital in the period 2005-2019.

Specifically, change in surgical technique and graft choice will be analyzed.


Eligibility Criteria:
Inclusion Criteria:

* Patient \>18 years
* Primary ACL reconstruction

Exclusion Criteria:

* Multiligament reconstruction
* Revisions
* ACL reconstruction with double bundle graft
Quality of Life in Patients With Alcohol Use Disorder

The primary purpose of this study is to investigate the factors associated with quality of life of patients with alcohol use disorder (AUD) undergoing a detoxification program (cross-sectional analysis). The secondary purpose is (1) to identify the factors associated with change in quality of life between baseline and 6-month follow-up, and (2) to identify the factors associated with alcohol relapse at 6 months (longitudinal analyses).

The standard DSM-5-based clinical assessment of AUD includes the number of AUD criteria (between 2 and 11) as well as various parameters related to the patterns of alcohol use (e.g., frequency of use, frequency of heavy use). In the contemporary clinical practice, more "functional" assessment tools are emerging such as quality of life, autonomy, cognitive functioning, but also other non-specific lifestyle habits, such as sleep quality and sexual functioning. These indicators are important because they define the broad impact of AUD on individual's life, and they are part of the overall rehabilitation, beyond the mere question of the relationship to alcohol. However, the determinants of quality of life of patients with AUD patients undergoing a detoxification program, and the factors associated with change in quality of life are not well identified.

This prospective cohort study will recruit 200 patients undergoing a detoxification program (home-based or in addiction services). Patients' demographic data, socioeconomic status, physical diseases, medication use, clinical features of AUD, psychiatric variables, impulsivity, autonomy, sexual functioning, sleep quality, and cognitive functioning will be measured at baseline. The Alcohol Quality of Life Scale (AQoLS) will be completed at baseline and at 6-month follow-up. Alcohol status (relapse/abstinence) will be assessed at 6 months.

Eligibility Criteria:
Inclusion Criteria:

* DSM-5 AUD criteria
* At least 18 years of age
* Within the 10th and 21st day of a detoxification program.

Exclusion Criteria:

* Communication difficulties (insufficient level of French, major hearing or visual impairment, major cognitive deficit)
* Under guardianship
* Under justice control
* Cannot be reached by phone
Treatment of Children and Adolescents With Growth Failure Associated With Primary IGF-1 Deficiency

This is an extension study to Tercica study MS301 (NCT00125164) and is intended to collect long term safety and efficacy data on the continued use of recombinant human insulin-like growth factor-1 (rh IGF-1) in children and adolescents treated for primary IGF-1 deficiency (IGFD). The secondary objective is to use the data collected to learn more about the relationship of IGF-1 exposure to the promotion of normal growth and pubertal development.

Primary IGFD is a term that has been used to describe patients with intrinsic cellular defects in GH action. In this protocol, subjects that have completed one year of mecasermin treatment on Tercica protocol MS301 (NCT00125164) will be allowed to enroll in this extension study. All subjects were planned to receive treatment.

This is a Phase IIIb open-label, multi-center, parallel dose, extension study conducted in approximately 40 centers across the United States.

Eligibility Criteria:
Inclusion Criteria:

* Parents or legally authorized representatives must give signed informed consent before any trial related activities are conducted
* Where required, assent of the subject will be appropriately documented prior to any study related activities
* Completion of assessments at Visit 9 (Month 120 of Study MS301 \[NCT00125164\])

Exclusion Criteria:

* Incomplete participation in MS301 (NCT00125164)
* Known or suspected allergy to the trial product (mecasermin, recombinant human IGF-1 injection) or its formulation
* Development or presence of a chronic condition except as approved by the Medical Monitor
* Pregnancy
* Any social or medical condition that, in the opinion of the investigator, would be detrimental to either the subject or the study
Insulin Glulisine in Type 2 Diabetic Patients

To evaluate the efficacy of a single injection of glulisine before the main meal added to insulin glargine plus oral antidiabetic drugs (OADs) compared to insulin glargine plus OADs in Type 2 diabetic patients poorly controlled with basal insulin plus OADs.


Eligibility Criteria:
Inclusion Criteria:

* Diabetes Mellitus, Type 2
* 25 \< BMI \< 45 kg/m²
* 7,5% \< HbA1c \< 9%
* Treated with a basal insulin (NPH, Insulin Zinc, Insulin glargine or Insulin detemir), and at least 1g metformin daily, for more than 3 months

Exclusion Criteria:

* Type 1 diabetes mellitus
* Treatment with OADs only
* Treatment with thiazolidinediones, with exenatide or with pramlintide
* Treatment with an insulin other than basal insulin (Premix, rapid insulin, fast-acting insulin analogue)
* Active proliferative diabetic retinopathy,
* Pregnancy (women of childbearing potential must have a negative pregnancy test at study entry and effective contraception)
* Breast-feeding
* History of hypersensitivity to the study drugs or to drugs with a similar chemical structure.
* Treatment with systemic corticosteroids in the 3 months prior to study entry
* Treatment with any investigational product in the 2 months prior to study entry
* Previous treatment with insulin glulisine
* Likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol
* Clinically relevant cardiovascular, hepatic, neurological, endocrine, or other major disease making implementation of the protocol or interpretation of the study results difficult
* Impaired hepatic function
* Impaired renal function
* History of drug or alcohol abuse

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Study of the Regulation of Parathyroid Hormone Secretion in Pseudohypoparathyroidism

OBJECTIVES:

Determine the relationship between serum calcium concentrations and parathyroid hormone secretion in patients with pseudohypoparathyroidism.

PROTOCOL OUTLINE:

Patients are tested for parathyroid hormone response following sequential graded intravenous infusions of sodium citrate and calcium gluconate. Assays include ionized calcium and intact parathyroid hormone.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Pseudohypoparathyroidism, i.e.: Renal resistance to parathyroid hormone OR Albright hereditary osteodystrophy No other illness unless related to pseudohypoparathyroidism No pregnant women
A Trial of Pentoxifylline for the Treatment of Recurrent Aphthous Stomatitis

This is a randomized, double blind, placebo controlled trial of the use of pentoxifylline (oxpentifylline) for the treatment of recurrent mouth ulcers.

There are few effective treatments for recurrent aphthous stomatitis (cancer sores, recurrent mouth ulcers). Most existing treatments are palliative topical treatments. Some systemic drugs e.g. steroids and thalidomide can suppress the recurrence of mouth ulcers but have serious long term side effects. Pentoxifylline (also known as oxpentifylline) has been used systemically for many years to treat peripheral vascular disease and has a good side effect profile. It shares several actions with thalidomide but does not share its serious side effects. Furthermore, some small scale, open label clinical studies have indicated it may be very effective in treating recurrent aphthous stomatitis (RAS). This study enrolled patients with RAS for which no underlying cause could be identified. Patients kept a diary of the pattern of their mouth ulcers for 60 days to confirm the pattern of ulceration and provide baseline data. Those still qualified for the study were then randomized to treatment with pentoxifylline 400mg three times daily or an identical placebo tablet three times daily for a further 60 days during which they continued to keep a daily ulcer diary. At the end of this period, treatment was stopped and they kept the daily ulcer diary for a further 60 days to identify if any benefit from the treatment was continued after ceasing treatment.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of minor recurrent aphthous stomatitis
* 2 or more mouth ulcers per month for more than 6
* No current treatment for oral ulceration or willing to stop treatment
* Age 16 to 65 years

Exclusion Criteria:

* Taking ketorolac, theophylline or anti-hypertensive medication except diuretics (contra-indicated in patients treated with pentoxifylline)
* Systemic diseases that contra-indicate the use of pentoxifylline i.e. pregnancy, hypotension, ischaemic heart disease, acute myocardial infarction, cerebral or occular hemorrhage, renal or hepatic failure, porphyria or allergy to pentoxifylline.
* Patients with an underlying deficiency state or systemic disease that could cause recurrent mouth ulcers e.g. iron, vitamin B12 or foliate deficience, coeliac disease, Crohn's disease, ulcerative colitis, Behcet's disease or Aids.
Impact of a History of Tonsillectomy or Adenoidectomy on the Severity of COVID-19 : AMYVID Study

Little is known about the impact of tonsillectomy and/or adenoidectomy on the severity and presentation of respiratory infections, let alone COVID-19. Current knowledge of the role of NALT suggests that its absence may be associated with an increased risk of severe disease.

Assessing the impact of tonsillectomy and adenoidectomy on the risk of adverse evolution in COVID-19 would help to better identify patients at risk of adverse evolution, so that they can be rapidly offered appropriate treatment. It would also provide a better understanding of the pathophysiology of this infection.

Primary objective: to determine whether there is a link between a history of tonsillectomy or adenoidectomy and the risk of severe COVID-19.

Primary endpoint: proportion of patients with a history of tonsillectomy or adenoidectomy among those hospitalized for severe COVID-19.

The results of this study will be compared with a data-driven study of Covid patients without severe disease.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18 to 80
* Hospitalized in SMIT at CHU d'Angers between 01/03/2020 and 30/11/2021 for severe COVID-19 infection (at least 1 severity criterion)

Exclusion Criteria:

Long-term home oxygen therapy prior to COVID-19 infection

* Vaccination against COVID-19 with at least one dose of vaccine received prior to COVID-19 infection Confidential Page 11 of 15
* Inability to ascertain the presence or absence of a history of tonsillectomy or adenoidectomy
* Person objecting to participation in research
Durg Coated Balloon Angioplasty in Infrapopliteal Lesions

This study is a multicenter observational study designed to evaluate the the effectiveness and safety of drug-coated balloon (DCB) angioplasty for below the knee arterial lesions in patients critical with Limb Threatening Ischemia (CLTI).

Patients with critical limb ischemia (Rutherford category 4-5) and significant infrapopliteal lesions appropriate for angioplasty will be enrolled in this study. Subjects will be treated with the AcoArt drug coated balloon, then follow-up will be conducted at 1, 3, 6, 12 months after index procedure. Data on wound, ischemia, foot infection (WIfI) calcifications, clinical improvements, wound healing, freedom form target- lesion revascularization, patency of the target lesion and major adverse events will be collected.

Eligibility Criteria:
Inclusion Criteria:

1. Rutherford grade 4-5.
2. Patients who understand the purpose of this study, volunteer to participate in the experiment, sign informed consent and are willing to follow up.
3. Single or sequential de novo or restenotic lesions (stenosis ≥ 70% diameter reduction or occlusion) in the infrapopliteal arteries \>20 mm. Lesions should not extend beyond the ankle joint.
4. Successful wire crossing of the lesion. After the pre-dilation of the ordinary balloon, the angiography showed that there was continuous blood flow.
5. At least one of the infrapopliteal arteries received a drug-coated balloon.
6. For patients with aortoiliac artery disease and femoral-popliteal artery disease, after intravascular reconstruction, blood flow can be recanalized, and there is no residual stenosis of more than 50%.
7. In patients with lower extremity arterial thrombosis, after mechanical thrombectomy, percutaneous catheter thrombolysis, and thrombus removal, patients receiving blew the knee arterial drug balloon intervention.
8. Patients who have received DCB intervention for both lower limbs can be enrolled in the group according to the intracavitary treatment time.
9. Life expectancy\> 24 months.

Exclusion Criteria:

1. Blood flow was not successfully reestablished.
2. Patients with stroke, cerebral hemorrhage, gastrointestinal hemorrhage or myocardial infarction within 3 months before enrollment.
3. Patients who are known to be allergic to heparin, aspirin, other antiplatelet drugs, contrast agents, etc.
4. Patients who have participated in clinical trials of drugs or other medical devices that interfere with this clinical trial within the past 3 months.
5. Pregnant and lactating women.
6. Patients with Berg's disease.
7. Patients requiring major amputation based on preoperative evaluation of limb infection or severe ischemia
Rapid Histologic Assessment for Stereotactic Breast Biopsy: Enhancing Early Detection With Miniature Mass Spectrometry and AI

Breast cancer is the leading cancer among Taiwanese women, and it is the second leading cause of cancer-related deaths in women. The five-year survival rate for early-stage breast cancer (Stage 0 to II) is over 90%, significantly better than the survival rates for Stage III and Stage IV breast cancer, which are approximately 70% and 25%, respectively. As a result, breast cancer screening and early diagnosis have always been of great importance. Breast cancer screening relies on imaging examinations, and the diagnosis depends on imaging-guided tissue confirmation.

However, when a patient undergoes stereotactic breast biopsy due to suspicious lesions found in mammography, they typically have to wait about a week to receive the pathology results to determine whether the lesion is benign or malignant. For the patient, this waiting period can be agonizing, and for clinicians, earlier knowledge of pathology results would facilitate prompt staging evaluation and treatment planning for cancer.

The investigators use a special technique-paper spray ionization miniature mass spectrometry (PSI-MMS). According to preliminary research, with the assistance of AI, the miniature mass spectrometer can detect the benign or malignant nature of breast tissue within minutes and with decent accuracy. The investigators hope to continue research to further improve accuracy to meet clinical needs and aspire to have the opportunity to apply the miniature mass spectrometer to rapidly differentiate the molecular subtypes of breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Those who come for receiving vacuum-assisted stereotactic breast biopsy

Exclusion Criteria:

* Those who cannot or are unwilling to sign the informed consent.
Home-Based Exercise for Adults Living With Overweight and Obesity

The study aims to implement a 12-week home-based exercise programme utilising an online intervention delivery platform. The focus will be on increasing exercise behaviour within the participant's home setting using aerobic, resistance and flexibility exercises as well as behaviour change techniques. Following the programme, semi-structured interviews will be conducted, to explore participant experiences.

It is hypothesised that the exercise programme will be feasible, accessible and acceptable.


Eligibility Criteria:
Inclusion Criteria:

* BMI ≥25kg/m² or BMI ≥30kg/m²
* English speaking
* Able to follow visual and verbal instructions
* Access to the internet and accompanying technology (e.g. laptop or tablet)
* Physically able to undertake aerobic, resistance and flexibility exercise

Exclusion Criteria:

* Unable to provide informed consent
* Receiving invasive medical treatment or planned surgery preceding to, or during, the programme
* Severe mental or physical limitations precluding participation safely in the home environment
* No access to the internet and/or facilitative technology such as a laptop or tablet
* Pregnancy
* Current smoker or vaping.
* Currently or very recently stopped taking weight loss medication (within the last two weeks)
* Recently experienced substantial weight change (defined as 5% within 6-12 months)
* Presence of contraindications to exercise
* Pacemaker and/or other implanted metal device
* At high risk of cardiovascular event
Patient Related Outcomes for Gynecologic Radiation Oncology

The goal of this study is to see if it is feasible to use electronic questionnaires to measure patient related outcomes before, during, and after radiation for gynecologic cancer in a high-volume radiation oncology clinic.

Other studies have found benefits from using patient related outcome measurements (PROM) in clinical settings, and a paper PROM is part of standard of care treatment for prostate cancer patients at the University of North Carolina clinic. However, PROM are not routinely collected for gynecological cancer patients at UNC, and fewer studies have specifically focused on PROM for gynecological cancer patients receiving radiation. The primary objective of this study is to determine the feasibility of PRO monitoring of gynecologic symptoms before, during (at weekly intervals), and after radiation (external beam radiotherapy and brachytherapy) for gynecologic cancer patients at a high volume center.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* English speaking
* Informed consent reviewed and signed
* Gynecologic cancer being treated by radiation at UNC
* Able and willing to complete web-based symptom survey

Exclusion Criteria:

* Inability to read and speak English
* Current incarceration
* Pregnancy
* Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rending of informed consent (with the caveat that if they initially are hospitalized with delirium which is subsequently resolved, they can then be consented for participation at a later time)
Radiation Exposure Reduction Protocol for Minimally Invasive Lumbar Decompression (mild) Techniques

To evaluate the efficacy of radiation reduction techniques to minimize clinician and patient exposure during minimally invasive lumbar decompression (MILD) procedure. Additionally, to evaluate the clinical benefits of single incision access for bilateral mild procedure.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 65 years old
* Patient has meets eligibility criteria for (mild)
* Patient has signed study-specific informed consent form
* Patient has the necessary mental capacity to participate and is physically able to comply with study protocol requirements
* Patient has medical insurance that covers this standard of care procedure and all other anticipated and unanticipated procedure related care.

Exclusion Criteria:

* Patient does not meet criteria for mild
* Patient is unable to receive radiation exposure.
* Current local or systemic infection that raises the risk of surgery
* Patient currently receiving or seeking worker's compensation, disability remuneration, and/or involved in injury litigation.
* Currently pregnant
* Known or suspected drug or alcohol abuse
* Diagnosed psychiatric disease (e.g., schizophrenia, major depression, personality disorders) that could interfere with study participation
* Patient is participating in an investigational study or has been involved in an investigational study within 3 months prior to evaluation for participation
* Implanted intrathecal pain pump or spinal cord stimulator system in place
* Patient who has received other means pain management with minimally invasive implantable devices (spacer, sacroiliac joint (SIJ) fusion, etc).
* Patient with physical inability to ambulate independently, otherwise.
* Patient underlying neurologic pathology preventing safe independent ambulation.