cyrilzakka/clinical-trials huggingface dataset:
Arthroscopic Treatment of Partial Rotator Cuff Tears in Shoulder Joint

A retrospective analysis was performed on patients with partial-thickness rotator cuff tendon tears who underwent arthroscopic surgery from August 2006 to December 2011. To evaluate functional outcomes and tendon healing after arthroscopy.

To study the surgical method and clinical effect of arthroscopic treatment of rotator cuff tendon tear. Retrospective analysis was performed on patients with rotator cuff tendon tears who underwent arthroscopic surgery from August 2006 to December 2011. Preoperative X-ray and MRI were performed. Rotator cuff repair was performed during the operation. UCLA shoulder scoring scale was used to evaluate the shoulder joint at preoperative and final follow-up.

Eligibility Criteria:
Inclusion Criteria:

* From August 2006 to December 2011, patients with partial-thickness rotator cuff tendon tears who underwent arthroscopic surgery in our department and were successfully followed up.

Exclusion Criteria:

* Patients with frozen shoulder and shoulder joint instability.
Sleep Extension and Behavior of Young Children

This pseudo-randomized intervention study examined change in inhibitory control following a sleep manipulation in which children with and without ADHD were instructed to advance their bedtime by 90 minutes for five days.

Objective: To evaluate the efficacy of a sleep extension intervention in young children with ADHD and determine whether sleep extension improves inhibitory control, a primary deficit in ADHD.

Design: Children with and without ADHD completed two 5-day assessments: a baseline condition in which children followed their normal bedtime routine and a sleep extension condition in which children were instructed to go to bed 90 minutes earlier than their habitual bedtime. Sleep was assessed with actigraphy and, on the final night, polysomnography. A Go/No-Go task was used to assess inhibitory control.

Setting: Participants slept in their home on nights 1-4 and in the sleep laboratory on night 5 of each condition.

Main Outcomes and Measures: Of interest is actigraph measurement of total sleep time for the baseline compared to the sleep extension condition. Polysomnography will be used to compared changes in sleep physiology. The primary behavioral outcome is inhibitory control, indexed by accuracy on No-Go trials in the Go/No-Go task.

Eligibility Criteria:
Inclusion Criteria:

* A subset of children were required to have an ADHD diagnosis

Exclusion Criteria:

* diagnosis of intellectual disabilities or developmental delay
* current diagnosis of history of sleep disorder
* uncorrected hearing or visual impairments
Lipid Biomarker Study in Men With Dyslipidemia After Simvastatin Treatment (Study MK-0000-140)(COMPLETED)

The purpose of this study was to provide human lipidomics standards with simvastatin treatment that were to be used for comparison with similar preclinical studies.


Eligibility Criteria:
Inclusion Criteria:

* Participant is a Caucasian (including Hispanic) male
* Participant has a maximum waist size of 40 inches
* Participant does not currently use any lipid-altering medications
* Participant is in good health other than the diagnosis of dyslipidemia

Exclusion Criteria:

* Participant has had stomach ulcers within the last 3 months
* Participant has had a heart attack in the last 6 months or has angina
* Participant has chronic heart failure
* Participant has a history of stroke, seizures, or major neurological disorder
* Participant has a history of cancer
* Participant has a gastrointestinal condition that affects bowel movements
* Participant has type 1 or 2 diabetes
Impact of Exenatide on Sleep Duration

This study investigates the effect of exenatide, a FDA approved medication for the treatment of type 2 diabetes on sleep duration and quality. Individuals with type 2 diabetes will be studied before and during treatment with Exenatide.

Enrolled individuals will be asked to come to the University of Chicago for 3-4 outpatient visits over the course of 3-4 months.


Eligibility Criteria:
Inclusion Criteria:

Patients taking diabetes medications other then insulin will be included, but changes to their medications may be made as deemed necessary by their physician. Patients on stable medications for chronic and co-morbid conditions (high blood pressure, high cholesterol, etc) will be eligible

Exclusion Criteria:

Patients with moderate or severe kidney disease and history of pancreatitis or patients on insulin will be excluded, as Exenatide use is contraindicated or risky in these conditions.

Patients with unstable cardiac, neurological or psychiatric disease and women who are pregnant or trying to get pregnant will be excluded. Patients who have severe COPD, severe neuropathy or chronic pain, which could impair sleep, will be excluded. Shift workers will be also excluded.
Single-dose Nicotine Pharmacokinetics With a New Oral Nicotine Replacement Product

A comparison of three products for oral nicotine replacement with respect to pharmacokinetics after single-dose of nicotine.

This study compares a new oral Nicotine Replacement Therapy (NRT) product with NiQuitin™ lozenge 4 mg and Nicorette®gum 4 mg, after 12 hours of nicotine abstinence, with respect to nicotine pharmacokinetics, during 12 hours after start of administration. Single doses of each treatment are given once in the morning during five separate treatment visits scheduled in a crossover setting with randomized treatment sequences. The study will include 45 healthy smokers between 18-50 years, who have been smoking at least 15 cigarettes daily during at least one year preceding inclusion. Subjects and study personnel will be aware of which treatment is administered at a given visit.

Eligibility Criteria:
Inclusion Criteria:

* Healthy smokers, smoking at least 15 cigarettes daily during at least one year preceding inclusion and BMI between 17.5 and 30.0 kg/m2.
* Female participants of child-bearing potential are required to use a medically acceptable means of birth control.
* A personally signed and dated informed consent document, indicating that the subject has been informed of all pertinent aspects of the study.

Exclusion Criteria:

* Pregnancy, lactation or intended pregnancy.
* Treatment with an investigational product or donation or loss of blood within 3 months preceding the first dose of study medication.
Comparison of Loss of Resistance Techniques

The purpose of this study is to determine whether there is a difference in success outcome of the combined spinal epidural labor analgesia between air versus saline when used to identify the epidural space.

When the epidural needle is inserted initially, it is typically connected to a syringe filled with 2-3 ml or air or saline. This is used to help identify the placement of the epidural needle. Both air and saline are commonly used and it is not clear and debatable which is a better method to identify the correct placement of the needle. Some doctors like using air in the syringe because when a drop of clear fluid returned from the smaller spinal needle, it would be clear to indicate the correct space for first dose of medicine since no pre-existing fluid was used. In group Saline, 3 mL of saline will be used. In group Air, 3 mL of air will be used in the syringe during the procedure.

The medicine will be administered in the usual manner the doctor has identified the correct location for administration. The amount of pain during labor will be assessed the patient giving a number from 0 to 10 with 0 being no pain and 10 being the worst pain.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant females weighing less than or equal to 250 lbs
* Request for neuraxial labor analgesia

Exclusion Criteria:

* ASA physical status greater than II
Evaluation of Laparoscopic Cholecystectomy and Concomitant Paraumbilical Hernia Repair

Umbilical hernia frequently accompanies cholelithiasis. It is possible to repair these hernias after completing cholecystectomy.

Laparoscopy is a type of surgical procedure that allows a surgeon to access the inside of the abdomen and pelvis without having to make large incisions in the skin.

The use of laparoscopy in abdominal surgeries increases for its great benefits over open surgery as:

1)faster recovery, 2)shorter hospital stays 3)decrease blood loss, 4)decreased postoperative pain 5)earlier return to work and resumption of normal daily activity as well as, 6)cosmetic benefits. few studies discuss the efficacy and safety of using Laparoscopy in management of lap cholecyctectomy and concomitant paraumbilical hernia repair

Eligibility Criteria:
Inclusion Criteria:

* Any age, any sex of patients with chronic calcular cholecystitis associated with para-umbilical hernia

Exclusion Criteria:

* Patients with associated diseases such as chronic pulmonary disease, cardiac disease, chronic renal failure.

patients with strangulated para-umbilical hernia

patients with recurrent paraumbilical hernia
Comparison of Different Mucoactive Agents for the Care of the Intubated Patient in a Surgical Trauma Intensive Care Unit

This study compares N-acetylcysteine (mucomyst) and sodium chloride to determine their efficacy in the prevention of pulmonary mucus obstruction and retention in intubated patients admitted to the surgical trauma intensive care unit (STICU).


Eligibility Criteria:
Inclusion Criteria:

* Intubated and admitted to the Surgical Trauma Intensive Care Unit (STICU)
* Subjects must be eligible to start treatment within 24 hours of their initial intubation

Exclusion Criteria:

* Patient anticipated to be extubated within 24 hours following STICU admission
* Hypersensitivity to acetylcysteine.
* Pregnancy
Comparing the Effects of Multicomponent Exercise on Cardiovascular Health and Lipid Profiles in Premenopausal and Postmenopausal Women

Background: The present study aimed to examine the effects of a 26-week multicomponent exercise program on lipid and lipoprotein profiles, blood pressure, and anthropometric parameters in healthy but sedentary premenopausal and postmenopausal women aged 40-60.

Method: The program, comprising resistance, balance, flexibility, and aerobic exercises, aimed to identify group-specific responses and establish the program's efficacy in mitigating cardiovascular risks. Seventy-five women were recruited, and 38 completed the intervention. Participants were categorized into premenopausal (n=18), postmenopausal (n=10), and control groups (n=10). Key measures included total cholesterol, low- and high-density lipoprotein cholesterol, triglycerides, glucose, systolic and diastolic blood pressure, and anthropometric variables. Statistical analyses employed the Shapiro-Wilk test, paired t-tests, Wilcoxon tests, and Kruskal-Wallis tests, with α=0.05.


Eligibility Criteria:
Inclusion Criteria:

* women aged between 40 and 60 years old;
* healthy, asymptomatic, and non-smoking;
* medical diagnosis favouring the engagement in physical-sporting activities;
* absence of clinical history related to alcoholism or uncontrolled metabolic disease;
* no clinical prescription for hypotensive pharmacological intake, cholesterol reduction, hormonal replacement therapy, or any other intervention capable of inducing alterations in lipid and lipoprotein metabolism; or
* abnormal blood sample results.

Exclusion Criteria:

* non-fulfilment of inclusion criteria;
* clinical history characterized by symptoms related to cardiovascular disease (CVD), including stroke (CVA) and coronary vascular disease (CVD), renal or hepatic disease, musculoskeletal disorders, or rheumatoid conditions that may impede full participation in the exercise program.
Optimizing Resource Utilization During Proficiency-based Training of Suturing Skills to Medical Students

Evidence favours teaching procedural skills to medical students using a proficiency-based rather than time-based approach. Basic suturing skills can be taught through faculty-led, peer tutor-led, and computer augmented approaches. One method has yet to be identified as superior in terms of educational outcomes, resource utilization, and participant perspectives.

Pre-clerkship medical students were randomized to: faculty, peer tutor, or computer augmented learning. Participants practiced suturing through their randomized method until they reached targeted proficiency defined using hand motion analysis (HMA). Proficiency was defined as a score of the average plus a standard deviation of five surgeons' HMA for two of three consecutive sutures using appropriate technique.

The primary outcome was the number of stitches placed to achieve proficiency. The secondary outcomes were the number of sutures used, time, and costs incurred. Learning curves were constructed. Participants' perceptions were assessed using a follow-up survey.


Eligibility Criteria:
Inclusion Criteria:

* Second year, pre-clerkship medical students

Exclusion Criteria:

* None
Study for the Validation of a New Biomarker to Determine Predisposition to Infections in Patients With Acute Myocardial Infarction.

Prospective biomedical research study

The aim is to validate a new biomarker, based on the levels of DNAmit present in blood, to assess the predisposition of an individual to suffer an infection. To validate this hypothesis, the DNAmit levels of patients with myocardial infarction will be analysed and their relationship with the probability of these patients developing an infectious process or not.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have suffered AMI or cardiorespiratory arrest after AMI, have been admitted to hospital within the first 24 hours of the event and are required to be admitted to any Critical Care Unit. In addition, one of the following criteria must be met:

  1. Symptoms of cardiac ischaemia.
  2. New ischaemic patterns in the ECG.
  3. Development of pathological QW waves on the ECG.
  4. Obvious suspicion or loss of myocardial viability or new abnormal motility regions in a pattern consistent with ischaemic pathology.
  5. Intracoronary thrombus detected on angiography or autopsy. 2. They must be of legal age, have read the Patient Information Sheet (HIP) and have signed the Informed Consent (IC).

     Depending on the group in which they are to be classified, patients must meet specific inclusion criteria:

     Group A: Patients who have suffered MI (myocardial infarction), are in the CRITICAL UNIT and their DNAmit values are below 0.25-105 copies.

     Group B: Patients who have suffered an MI, are in the CRITICAL UNIT and their mtDNA values are above 0.25-105 copies.

     Exclusion Criteria:

     Patients who meet any of the following criteria shall not be eligible for inclusion in the clinical trial:
     1. Chronic inflammatory diseases
     2. Transplantation of any organ (except cornea).
     3. Patients receiving or who have received in the last 3 months anti-inflammatory, immunosuppressive or biological treatment targeting the immune system (TNF blockers, anakinra, rituximab, abatacept or tocilizumab), except NSAIDs and colchicine.
     4. Patients with overt and/or severe immunocompromise
     5. History of chronic kidney or liver disease (dialysis or creatinine clearance \< 30%).
     6. Decompensated diabetes
     7. Active tumour process. Patients considered to be in complete remission may be included in the study.
     8. Major surgical intervention (in the 3 MONTHS PRIOR to inclusion in the study).
     9. Pregnancy, childbirth or breastfeeding in the last 3 months.
     10. Symptomatic patients with type IV heart failure (NYHA).
     11. Life expectancy of less than 3 months.
     12. Long-term urinary catheter or vascular catheter wearers
Clitoral Therapy Device in Alleviating Sexual Dysfunction After Genital Mutilation.

The aim of this study to determine the effect of clitoral therapy device EROS device/ on sexual dysfunction after genital mutilation.

Little attention has been given to women who exposed to genital mutilation surgery in early age in the middle east. Most of them suffer from sexual dysfunction of sexual arousal and orgasm when they get in an intimate relation with their husbands after marriage. Clitoral therapy device may improve sexual arousal and alleviate sexual dysfunction symptoms to a great extent.

Eligibility Criteria:
Inclusion Criteria:

* All are suffering sexual dysfunction of sexual arousal and all referred from the family planning and reproductive health department, National research Center.

Exclusion Criteria:

* Metastatic disease, severe bowel or bladder sequelae, and significant comorbidities. Women with a history of sexual trauma or abuse, or undergoing current antidepressant therapy were excluded.
A Study to Assess the Efficacy and Safety of Salix Probiotic Blend in Participants With Functional Gastrointestinal Disturbances

The primary objective of this study is to assess the safety and efficacy of Salix Probiotic Blend, administered orally for 30 days, in participants with functional gastrointestinal (GI) disturbances.


Eligibility Criteria:
Inclusion Criteria:

* Participants who have symptoms of GI disturbances.
* Participant has recurrent abdominal pain, discomfort, bloating, and/or abdominal distention associated with a change in the frequency of stool and/or a change in the form (appearance) of stool.
* Participant is able to understand the nature and purpose of the study and provide informed consent.
* Sexually active males and sexually active females of child-bearing potential, defined as neither surgically sterile nor post-menopausal (that is, females age \>45 years and no menstrual periods for at least 1 year), must agree to use a highly effective method of contraception from Screening to 30 days post last dose of study product. Acceptable forms of contraception include the following:

  * Abstinence
  * Oral, injected, or implanted hormonal methods of contraception
  * Intrauterine device or intrauterine contraceptive system
  * Condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository
  * Female whose last sexual intercourse with males was ≥6 months post-vasectomy

Exclusion Criteria:

* Participant has active or a history of inflammatory bowel disease.
* Participant has other significant systemic diseases such as active cancer therapy, active/ongoing infection, uncontrolled diabetes, chronic renal failure, cirrhosis, congestive heart failure, and severe Chronic Obstructive Pulmonary Disease (COPD).
* Participant has used antipsychotic medications within 3 months prior to Screening.
* Participant has used systemic steroids within the month prior to Screening.
* Participant has suffered from a major psychiatric disorder within the past 2 years.
* Participant is pregnant or breastfeeding.
* Participant has a known lactose intolerance.
* Participant is immunocompromised or has an immunodeficiency syndrome of any kind.
* Participant has undergone any abdominal surgery, except for hernia repair or appendectomy.
* Participant has had active treatment with prescription medication for irritable bowel syndrome (IBS) within 6 weeks prior to Screening.
* Participant has been diagnosed with infectious gastroenteritis within 1 month prior to Screening.
* Participant has undergone treatment with probiotics within 6 weeks prior to Screening.
* Participant is on active treatment with antibiotics.
* Participant has a known fructose intolerance.
* Participant is currently on a low fermentable oligo-, di-, mono-saccharides and polyols (FODMAP) diet.
* Participant has a known diagnosis of gastroparesis.
Reveal LINQ™ Evaluation of Fluid

The purpose of this study is to investigate the use of subcutaneous impedance measured with an implanted Medtronic Reveal LINQ™ insertable cardiac monitor for use as a fluid status monitor in hemodialysis patients. The study will measure the changes in subject subcutaneous impedance and compare with the fluid status assessed by the volume removed from the hemodialysis subject during dialysis sessions. Subcutaneous impedance trends will also be evaluated between dialysis sessions.


Eligibility Criteria:
Inclusion Criteria:

* Patients who currently undergo in-clinic hemodialysis treatment prescribed 2 or 3 times per week
* Patients willing to be implanted with the Reveal LINQ™ device
* Patients greater than 21 years of age
* Patients willing and able to comply with the study procedures including giving informed consent

Exclusion Criteria:

* Patient has an active implanted cardiac medical device (e.g. IPG, ICD, CRT, etc)
* Patients who currently undergo home dialysis treatment
* Patient is enrolled in another study that could confound the results of this study, without documented pre-approval from a Medtronic study manager.
* Patient with a recent infection defined as 1) bacteremia within 60 days OR 2) (nonbacteremic) infection within 14 days
* Patient not suitable for Reveal LINQ™ implantation (e.g., severe cachexia, dermatologic conditions of the skin, or major medical or social conditions expected to reduce survival to \< 6 months), in the opinion of the investigator
The Study is Observational and Retrospective: Lifestyle, BMI and Activity Physical.

The goal of this observational-retrospective study is to learn about the long-term effects of a lifestyle intervention inclusive of dietary counselling and physical activity advice, on body weight in female breast cancer survivors who took the intervention in previous years compared to those who did not take it.

The main question it aims to answer is:

Does a long-term lifestyle intervention help to control body weight 5 years after breast cancer diagnosis? Participants are asked to answer online survey questions about their anthropomethry, clinical conditions, socio-economical status, dietary habits, physical activity levels, quality of life, sleep quality and pshycological distress.

Investigators will use data from 428 women with a 5-yr primary diagnosis of BC (stages I-III at ages ≥30 \<75 anni). Half of this sample (N=214) who followed integrated lifestyle treatment of behavioral modification of diet and physical activity conducted by Pascale Institute since 2016; the other half (N=214) will be patients who were eligible to participate but did not for logistic reasons.

The present study aims to enroll 428 women with prior primary diagnosis of breast cancer. Half of the patients (N = 214) had previously followed the lifestyle treatment of DEDiCa trial on the modification of eating and physical activity habits (Eudract n. 2015-005147-14) conducted by the Oncologic Institute Pascale in Naples (Italy) since Nov 2016; the other half of the patients were 214 who had refused to participate in the aforementioned trial for reasons unrelated to serious health conditions or progression of the disease.

Eligibility Criteria:
Inclusion Criteria:

1. Surgery for primary breast cancer performed at least 5 years prior to the interview.
2. Women who have joined the DEDiCa trial or who have refused to participate for reasons not related to serious health conditions or disease progression.
3. Those who are able to sign the informed consent.

Exclusion Criteria:

1. Age \<30 years.
2. Primary diagnosis of metastatic breast cancer.
3. Diagnosis of other malignancies prior to the diagnosis of breast cancer.
4. Those who are unable to sign the informed consent or who deny to be contacted by telephone.