cyrilzakka/clinical-trials huggingface dataset:
Risk Factors for Failure After Single-incision Sling Procedure in Women With Stress Urinary Incontinence

The main risk factors for failure after single-incision slings are reduced urethral mobility and stress urinary incontinence severity in long-term follow-up.

The medical records of the 132 patients were retrospectively analyzed. Preoperative assessment included medical history and urogynecological examination. Patients were asked to answer validated questionnaires such as Urinary Distress Inventory (UDI-6) and Incontinence Impact Questionnaire (IIQ-7). Objective cure of SUI was defined as the absence of demonstrable leakage of urine on the cough stress test. Subjective cure was based on negative response to UDI-6, question 3. Patients were divided according to objective cure rate into two groups: cured (Group A) and failed patients (Group B).

Eligibility Criteria:
Inclusion Criteria:

Women who underwent single-incision sling procedure for stress urinary incontinence

Exclusion Criteria:

Urodinamically proven detrusor overactivity

Neurogenic bladder

Previous anti-incontinence surgery including midurethral slings

Postvoidal residual volume (PVR) \>100mL

Previous radical pelvic surgery

Anterior pelvic organ prolapse greater than stage I
Effect of Brief-tele Support on Attendance at Physiotherapy Sessions

Patients on the waiting list for physiotherapy treatment for pelvic floor dysfunction will be randomly divided into three groups:

* a group that gets a telephone call before their invitation letter is sent.
* a group that gets a telephone call after their invitation letter is sent.
* a group that does not receive a telephone call.

The phone call is a brief 5-10 minute call, which will be semi-structured. It will remind the patient of their appointment time, it will outline what the treatment involves and highlight the potential benefits and drawbacks, and allow the patient to ask questions about the treatment.

Aims:

The research aims to assess the impact of a brief telephone call to patients with pelvic floor problems who are on a waiting list for physiotherapy treatment. Non-attendance at sessions currently runs at about 50%, and steps to reduce this would be beneficial to patient health and NHS efficiency.

Participants and Recruitment:

Consecutive patients who have been referred for physiotherapy treatment for pelvic floor dysfunction will be asked if they would like to participate in the study. The initial approach will be made through a letter, which will give information about the study, and will make clear that their treatment will not depend on their participation in the study.

Patients on the waiting list for physiotherapy treatment for pelvic floor dysfunction will be randomly divided into three groups:

* a group that gets a telephone call before their invitation letter is sent
* a group that gets a telephone call after their invitation letter is sent
* a group that does not receive a telephone call.

The phone call is a brief 5-10 minute call, which will be semi-structured. It will remind the patient of their appointment time, it will outline what the treatment involves and highlight the potential benefits and drawbacks, and allow the patient to ask questions about the treatment.

Eligibility Criteria:
Inclusion Criteria:

* Women on waiting list for pelvic floor dysfunction
* over 18 years old

Exclusion Criteria:
Atlantic Lipid Lowering Treatment Optimization Program

Hypercholesterolemia is recognized as the major driver for cardiovascular morbidity and mortality. To help address this in our community, Atlantic Medical Group (AMG) formed a lipid workgroup chaired by Robert D. Fishberg, MD, and Jeffrey N. Feldman, MD. The overarching goal of the lipid workgroup is to enhance the treatment of lipid disorders in those patients with abnormal lipid levels by improving access to resources at the primary care practice level and specialty level. We aim to develop a model for primary and secondary prevention that integrates guidelines for treatment at the practice level. Our primary objective is to identify high-risk patients by utilizing the electronic health record and partnering with patients' primary care providers to provide comprehensive medical management.

This study will screen patients with LDL-C \>160 mg/dL and with evidence of familial hypertension, reach out (using secure chat) to the attending practitioner of such patients and inform the practitioner of our comprehensive services to address FH. A study team member will inform the practitioner that one of the study team plans to reach out to their patient to inform the patient of the study. Unless one of the study team receives notification by the practitioner that they want to opt out of this service for their patients, and do not want further interaction, the patient will be informed of the study and the consent process.

The research question is: Will an innovative comprehensive outreach approach, in conjunction with the primary care provider, reduce LDL-C levels in individuals with familial hypercholesteremia below individual baseline values, ideally at a level at or below 100 mg/dL.

Eligibility Criteria:
Inclusion Criteria:

* LDL-C ≥160 mg/dL
* Untreated LDL-C ≥190 with family history of CAD
* Prior MI and currently without optimized lipid-lowering therapy
* Family history of CAD in first degree relative
* Personal history of CAD
* Untreated triglycerides \>500
* Elevated Lp(a) and/or high calcium scores
* Consenting individuals

Exclusion Criteria:

* Individuals who are pregnant
* Individuals who are incarcerated
* Individuals with a terminal illness
* Individuals who do not consent
Immunotherapy With APC8015 (Sipuleucel-T, Provenge) for Asymptomatic, Metastatic, Hormone-Refractory Prostate Cancer

This is a randomized, double blind, placebo controlled trial of immunotherapy with autologous antigen-loaded dendritic cells (Provenge, APC8015) for asymptomatic, metastatic, hormone-refractory prostate cancer.


Eligibility Criteria:
Inclusion Criteria:

* Histologically documented adenocarcinoma of the prostate
* Metastatic disease as evidenced by soft tissue and/or bony metastases
* Prostate-specific antigen value of at least 5 ng/mL
* Tumor progression while on hormonal therapy
* Castration levels of testosterone (defined as less than 50 ng/dL)
* Life expectancy of at least 16 weeks
* Adequate hematologic, renal, and liver function

Exclusion Criteria:

* Visceral organ metastases
* Metastatic disease expected to be in need of radiation therapy within 4 months.
* Concurrent therapy with experimental agents
A Nordic Phase II Study of PTCL Based on Dose-intensive Induction and High-dose Consolidation With ASCT

This is a phase II prospective non-randomised clinical trial in newly diagnosed and previously untreated adult patients in the age range 18-60 (67) years with peripheral T-cell lymphoma.

The treatment schedule will consist of three phases: induction and high-dose consolidation, followed by autologous stem cell rescue. There will be two different induction schedules: one for patients in the age range 18-60 years and one for patients aged over 60 years.


Eligibility Criteria:
Inclusion Criteria:

* Previously untreated patients with newly diagnosed peripheral T-cell lymphoma of all stages. However, patients with nodal stage IA non-bulky disease (\<10cm) can be treated individually at the discretion of the responsible physician.
* Following histologic subtypes (WHO classification) are eligible for inclusion in the study:

Peripheral T-cell lymphomas, unspecified Angioimmunoblastic T-cell lymphoma NK/T nasal-type T-cell lymphoma Enteropathy-type T-cell lymphoma Primary systemic, alk-negative anaplastic large cell lymphoma (T-or null phenotype) Hepatosplenic T-cell lymphoma Subcutaneous panniculitis-like T-cell lymphoma

NB: Patients should not enter the treatment program before confirmation of the histo-pathological diagnosis by the referral center pathologist

* Age 18-60 years. Patients in the age range 61-67 years may be included in this protocol at discretion of the treating physician.
* formed consent based on oral and written patient information (Appendix I)

Exclusion Criteria:

* Primary cutaneous T-or null-cell anaplastic large-cell lymphoma
* Alk-positive, primary systemic T-or null-cell anaplastic large-cell lymphoma
* WHO Performance Status grade 4 (Appendix II)
* Patients with severe cardiac (i.e. severe heart failure requiring symptomatic treatment or a cardiac ejection fraction of less than 45%), pulmonary, neurologic, psychiatric, renal, hepatic or metabolic disease.
* Pregnancy. N.B: Women of childbearing potential should be strongly advised to apply appropriate contraceptive precautions during the entire treatment period.
* Patients with concomitant malignancies except for non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma.
* Patients with seropositivity for the human immunodeficiency virus.
* Patients with other active and therapeutically uncontrolled infection.
* Psychological, familial, social or other condition/-s potentially hampering compliance and follow-up.
A Study of RGLS8429 in Healthy Volunteers

Primary Objective

• To assess the safety and tolerability of single ascending doses of RGLS8429

Secondary Objectives

* To identify dose-limiting toxicity (DLT) and to determine the maximum tolerated dose (MTD) of a single SC dose of RGLS8429
* To characterize the pharmacokinetic (PK) properties of RGLS8429

In this randomized, double-blind, placebo-controlled Phase 1 study, a single ascending dose of RGLS8429 or placebo will be administered via subcutaneous (SC) injection to healthy volunteers to evaluate the safety, tolerability, and PK of RGLS8429.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female, 18 to 55 years of age
2. Body mass index (BMI) 18 to 35 kg/m2
3. Medically healthy, with no clinically significant medical history in the opinion of the Investigator
4. Estimated glomerular filtration rate (eGFR) ≥ 90 mL/min/1.73 m2
5. Must understand and consent to the study procedures explained in the informed consent form (ICF) and be willing and able to comply with the protocol

Exclusion Criteria:

1. Subject is mentally incapacitated or has significant emotional problems
2. Any medical condition or social circumstance that, in the opinion of the Investigator, may make the subject unlikely to complete the study or comply with study procedures and requirements, or may pose a risk to the subject's safety
3. History or presence of alcoholism or drug abuse within the past 2 years prior to Screening
4. Participation in another clinical trial and/or exposure to any investigational drug or approved therapy for investigational use within 28 days or 5 half-lives of the investigational drug's dosing, whichever is longer, prior to dosing. The 28-day and 5-half-life windows will be calculated from the date of the last dosing in the previous study to Day 1 of the current study.
The Differences of Complications Between LPD(Laparoscopic Pancreaticoduodenectomy) and OPD(Open Pancreaticoduodenectomy)

Main objective: This project intends to design a simulated RCT project and clinically relevant RCT study to target, selecting the study titled "Short-Term outcomes Following Laparoscopic vs Open Pancreaticoduodenectomy in Patients With Pancreatic Ductal Adenocarcinoma: A Randomized Clinical Trial (Short-term Outcomes of Laparoscopic versus Open Pancreaticoduodenectomy in Patients with Pancreatic Ductal Adenocarcinoma)", use the cases in the Pancreatic Cancer Special Disease Cohort Database, compare the differences in complications and short-term prognosis between patients with pancreatic cancer after laparoscopic and open pancreaticoduodenectomy, investigate the efficacy and safety of laparoscopic pancreaticoduodenectomy, and provide the basis and reference of real-world data for clinical relevant studies. Secondary objective: To predict the incidence of postoperative complications and short-term outcomes of pancreatic cancer patients by comparing the difference of complications and short-term prognosis between laparoscopic and open pancreaticoduodenectomy, and to improve the treatment power of patients scheduled for surgery and postoperative patients.


Eligibility Criteria:
Inclusion Criteria:

* Age: 18 years old, with no gender limit;
* Histologically confirmed or clinically diagnosed as pancreatic cancer by MDT (multidisciplinary team), without histopathological evidence;
* Patients may receive LPD or OPD according to the MDT evaluation;
* Patients understand and are willing to comply with the trial;
* Signed written informed consent before patient enrollment;
* Patients who meet the clinical guidelines for intent to treat.
* Those who met each of the above criteria were included in the study.

Exclusion Criteria:

* Patients with distant metastasis found before or during surgery, including peritoneal, liver, distant lymph node metastasis, and other organ involvement;
* Patients who need pancreatic neck or pancreatic tail, total pancreatic resection or other palliative surgery;
* Preoperative anesthesia ASA score of 4 points;
* A history of other malignant tumors;
* Pregnant or lactating women;
* Patients with severe mental disorders;
* MDT evaluates patients with vascular invasion and requiring vascular resection based on abdominal imaging data;
* Patients who have participated in other clinical trials within 3 months. Those who meet any of the above criteria were not included in the study.
Non-deceptive Application of Placebos in Insomnia

The purpose of this study is to evaluate whether non-deceptive application of a placebo has an impact on subjective or objective sleep parameters in patients with primary insomnia.


Eligibility Criteria:
Inclusion Criteria:

* age between 18 years to 69 years
* fluent in German language
* provide written informed consent
* ability to understand the explanations and instructions given by the study physician and the investigator

Exclusion Criteria:

* evidence for sleep disorders caused by medical factors (e.g. sleep apnea, restless legs syndrome, narcolepsy, substance-induced insomnia)
* allergies to ingredients of placebo
* patients scoring below 8 or above 21 on the Insomnia Severity Index
* patients suffering from a mental disorder as verified by the SCID
* patients suffering from an acute physical illness
* nicotine consumption \> 10 cigarettes/day
* unwillingness to refrain from alcohol consumption throughout the study
* change in concomitant medication regime during the last 2 weeks prior to visit 1 or after randomization
* intake of psychotropic drugs during the last 3 months prior to visit 1
* currently pregnant (verified by urine pregnancy test) or lactating
COPD Exacerbation Blood and Urine Biomarkers Study

This will be a prospective study examining serum levels of MMP-13 and alpha-1 antitrypsin as well as other biomarkers as well as urine biomarkers of smoking status and collagen degradation in the COPD patient population. Serum and urine biomarkers at baseline and after COPD exacerbations will be assessed against change in lung function as measured by pulmonary function testing.

Chronic obstructive pulmonary disease (COPD), a term describing emphysema and chronic bronchitis, is the third leading cause of death in the United States, with approximately 24 million US adults estimated to have the disease and over 130,000 US adults dying each year due to COPD. Acute exacerbations of chronic obstructive pulmonary disease (AECOPD), primarily the result of viral respiratory infections, result in accelerated decline in lung function and increased mortality. Recent work in our laboratory demonstrates that matrix metalloproteinase-13 (MMP-13), which has both collagenolytic and elastolytic activity, is increased in the bronchoalveolar lavage fluid of patients with COPD. It is well accepted that viral infections have significant consequences in smokers, particularly in patients with AATD related COPD.

COPD exacerbations clinically manifest with increased dyspnea, cough and sputum production, and from a societal cost standpoint are associated with significant increases in health care utilization. Recent data suggest that viral infections such as RSV increase MMP-13 secretion and expression within lung tissues. Therefore, the studies presented here seek to understand the effect of MMP-13 on COPD progression and the effect of disease exacerbations on MMP-13 and alpha-1 antitrypsin serum levels and later lung function decline. The investigators hypothesize that patients with COPD, in particular patients who fall into the "frequent exacerbator" phenotype (two or more exacerbations within the last year), will have increased levels of MMP-13 as compared to the general non-COPD patient population and that in the setting of a COPD exacerbation, levels will be increased. The investigators will assess how exacerbation MMP-13 levels predict later lung function decline.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with COPD (FEV1 \<80% AND FEV1/FVC \< 70%)
* Ages 35-80yrs

Exclusion Criteria:

* History of Asthma
* Bronchiectasis
* Carcinoma of the bronchus
* Recent COPD exacerbation or pulmonary infection (less than 1 month)
* Other significant respiratory disease
* Pregnancy
Mindfulness Surgical Pain Outcomes

This will be a prospective randomized study to evaluate novel, clinically feasible, easily deliverable, pragmatic ways of preemptively modifying known CPSP and behavioral risk factors for acute to chronic pain transitions in adolescents before surgery. In addition, it will provide mechanistic insights and build a strong foundation for future large scale interventional studies that can impact outcomes positively in children undergoing surgery.


Eligibility Criteria:
Inclusion Criteria:

1. Aged 10-18 years
2. English speaking
3. Ability to provide assent/consent/parent permission
4. Scheduled to undergo elective major musculoskeletal surgeries including spine fusion (idiopathic scoliosis only), abdominal surgeries, thoracic surgery including pectus repair, and major orthopedic joint surgeries.

Exclusion Criteria:

1. Previous exposure to psychological interventions
2. Surgery within 1 year
3. Developmental delay
4. Chronic opioid use within 6 months prior to surgery
5. Severe systemic disease
A 13-years Nationwide Study of Alpine Accidents in Austria

Brief Summary:

This observational study intends to analyze the characteristic of specific accidents happened in Austrian's mountainous regions. The mechanisms of accidents which are evaluated are accidents while using a sleigh, climbing accidents, cycle accidents, canyoning accidents, hiking accidents, snowshoeing accidents, water-sport accidents, ski and snowboard accidents.

The data are collected retrospectively from the database of Austrian alpine police force. These data are analyzed. The information from this database (scene of accident, weather, daytime...) is compared to secondary data collected from the University Hospital of Innsbruck. The comparison of both databases was approved by the Austrian Data Protection Agency. The goal of the study is to give detailed information of circumstances leading to accident and give medical information of the patient's condition and his outcome.

The method to collect data and to analyze is the same than in AN4757 315/4.4 (NCT03405467).

Eligibility Criteria:
Inclusion Criteria:

* All patients with the criteria for an alpine accident characteristics described under "Conditions".

Exclusion Criteria:

* All patients without accident characteristics described under "Conditions".
* All patients which suffered an accident not in alpine environment.
Protein Supplementation in Infants With Brain Injury

To date, few studies have been done regarding nutrition supplementation in infants with brain injury. Therefore, the investigators are proposing to study the effects of protein supplementation in this group of babies. The investigators will recruit 24 infants with brain injury (evidence of hemorrhage, white matter injury, or gray matter injury) admitted to the Cincinnati Children's Hospital Neonatal Intensive Care Unit (NICU) into the study. Upon diagnosis, the investigators will obtain consent from the parents for participation in the study, then randomly assign the baby to one of two groups - an increased protein group and a control group. Both groups of infants will be monitored to ensure no adverse effects occur due to the supplementation.

Protein supplementation will continue for the first 12 months of age. Growth parameters, such as weight, length, and head circumference, will be measured while the infant is the NICU. Head circumference will be measured in the investigators outpatient clinic at three, six, and 12 months of age. At 18-22 months, the infants will be tested for neurodevelopmental outcomes using the Bayley Scales of Infant Development. The investigators hypothesize that infants who receive the additional protein will demonstrate increased head growth and improved neurodevelopmental outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Infants admitted to the NICU at CCHMC
* Known or suspected brain injury
* Parental consent obtained
* At least 48 hours of age at the time of randomization

Exclusion Criteria:

* Congenital or posthemorrhagic hydrocephalus
* Major congenital brain malformations
* Congenital gastrointestinal malformations or Bell Stage III NEC
* Inborn errors of metabolism
* Chromosomal abnormalities
* Significant cardiac disease
Efficacy of Acceptance and Commitment Therapy (ACT) in Group in Fibromyalgia

The main objective is to assess the efficacy of Acceptance \& Commitment Therapy (ACT) in group for the treatment of fibromyalgia. The secondary aims are: 1.- To assess the cost-effectiveness of ACT and 2.- To assess the efficacy of ACT in other variables such as anxiety, depression, pain or global function. 3.- To evaluate the usefulness or electroencephalographic cordance as a prognostic variable of the treatment.

HYPOTHESIS: ACT in group is effective for improvement of pain acceptance and other outcome variables (pain, anxiety, depression, global function) in fibromyalgia, and it is cost-effective. Cordance is an useful predictor of treatment efficacy in these patients.

DESIGN: Multicentre, randomized, controlled study, with parallel groups, and a 6-month follow-up period. Participants will be randomly allocated to one of two conditions: 1.- Group Acceptation \& Commitment Therapy or 2.- Treatment as usual by his general practitioner. Patients diagnosed of fibromyalgia, according to the American College of Rheumatology, will be recruited in primary care. Assuming an alpha=0.05 and p=80%, using two tails, and calculating 5% of refusals, it will be necessary a sample size of 55 patients for each group of patients.

The main outcome will be pain acceptance. Other outcome measures will be global function (assessed with the Fibromyalgia Impact Questionnaire, FIQ), cost-effectiveness (evaluated by the Client Service Receipt Inventory, CSRI) and electroencephalographic cordance. The mediating variables included are anxiety and depression (assessed with the Hospital Anxiety and Depression scale, HADS) and pain (measured with an analog visual scale). A psychiatric interview will be administered to the participants to diagnose Posttraumatic Stress Disorder. Statistical analysis will be carried out for intention to treat, and using the method Last Observation Carried Forward. A Repeated Measures Mixed Model will be used to study the main outcome. All calculations will be made with two tails and a significance of 0.05.

Eligibility Criteria:
Inclusion Criteria:

1. Age: 18-65 year old
2. Discontinuation drug treatment 7 days before the start of the trial
3. Not having received psychological treatment previously or at least in the last 2 years
4. Ability to understand Spanish
5. Given consent to participate in the study

Exclusion Criteria:

1. Age: \<18 year old and \> 65 year old
2. Clinical or psychological disease that, at investigator's opinion, can interfere the psychological examination or the adherence to psychotherapy (dementia, alcohol or drug abuse, psychosis, severe personality disorder)