cyrilzakka/clinical-trials huggingface dataset:
How Much is Too Much: Assessing Varying Pressure Pump Pressures in Post Operative Pain Control in Shoulder Arthroscopy.

Postoperative surgical pain has been extensively study with regard to anaesthesia pain modalities, however little is published with regards to various arthroscopic shoulder surgical techniques. An intriguing characteristic of shoulder arthroscopy is the various arthroscopic pump pressures used by different surgeons. One could hypothesize that excessive water retention from the arthroscopic pump could causes excessive tissue pressure and swelling resulting in post operative pain. Unfortunately we could not find any literature in the English language regarding varying pressure pump settings on post operative pain control. For that reason we would like to assess how variable pump pressure effect tissue pressure over pre set time points, and how this may relate to post operative pain control.


Eligibility Criteria:
Inclusion Criteria:

* Patients attending St. Joseph's hospital
* Shoulder pathology amenable to arthroscopic surgery
* Medically suitable for surgical management
* Able to consent for surgery.

Exclusion Criteria:

* Unable to consent
* Active infection
* Active malignancy
* Drug or alcohol misuse
* Work related injury
* Lack of permanent home residence
* Previous surgery to affected shoulder
* Medical contraindiction to surgery
* Pregnant women
Effects of Mirror Therapy Versus Fine Motor Activities on Hand Function in Chronic Stroke Patients.

to compare the effects of the Mirror therapy and fine motor activities on hand function in chronic stroke patients

This study will be conducted to compare the effects of mirror therapy and fine motor activities in chronic stroke patients. Total Twenty eight hemiplegic patients will be recruited according to inclusion criteria and data will be collected from Riphah rehabilitation centre Lahore and Mian Munshi Hospital Lahore (DHQ). The patients will randomly assigned to a mirror therapy group (n=14) and Fine motor activities group (n=14). The patients in both groups will undergo conventional therapy for 4 weeks (60minutes/day, 5 days/week). The patients will be evaluated at the beginning and end of the treatment by Fugl- Meyer Aassessment (FMA) wolf motor assessment scale and the Functional Independence Measure (FIM). After approval from ethical committee, data collection will be started and informed consent will be taken from all patients.

Eligibility Criteria:
Inclusion Criteria:

* A score greater than 24 on the Mini-Mental State examination test
* Chronic stroke patients whose episode of stroke onset was 6 months to 2 years.
* Patients who are able to communicate well and grasp the therapist's spoken instructions

Exclusion Criteria:

* Patients who have restricted joint movement in their healthy upper extremities.
* Neglect syndrome or a visual field deficiency
* Patients with recurrent stroke.
* Spine surgery.
β-lactam Use in Single-stage Exchange of ProstheTic Infections (Knee / Hip) in a Center of Reference (β-SEPTIC)

According to the official recommendations, infected prosthesis can be surgically treated by one or two-stage replacement. In Strasbourg, the investigators only perform one-stage surgery, which means that the new materiel is put directly into an infected site. To prevent re-infection, probabilist antibiotherapy has to be started the earlier as possible and to have the larger specter as possible. Official recommendations don't specify the best choice of antibiotherapy and let prescriptors make choice, according to the local epidemiology and patient's history.

In Strasbourg, the investigators systematically start an antibiotic against cocci gram positive: daptomycin. Sometimes, the investigators add tazocillin, a broad-spectrum β-lactam against bacillus gram negative. To determine if the investigators use the second one, they focalized on the presence of fistula or not. Indeed, enterobacteriae from gastro-intestinal tractus are also found on the skin and can move to the peri-prosthetic site if a fistula is created. The major disadvantage of this board-spectrum antibiotic is the selection and creation of resistant bacteriae, which can be responsible of failure, re-infection, or just spreading on the environnement.

The primary purpose is to evaluate retrospectively the prescription of tazocillin, judging it's necessity thanks to antibiograms performed on samples taken during surgery. The aim is to evaluate if the criteria " fistula or not " is a good one to guide the prescription of board-spectrum β-lactam.

Secondary purposes are to find the etiology of failures ( bacteriological failure or re-infection with a new pathogen), evaluate the apparition of multi-drug resistant bacteriae and infections they are responsible for, looking for others criterias which could help the investigators to choose the probablist antibiotherapy


Eligibility Criteria:
Inclusion Criteria:

* Adults ( \> 18 years-old) hospitalized from 1st January 2018 to 31th December 2018 in the septic orthopedic surgery unity of the university hospital of Strasbourg for a prosthetic-joint infection (knee or hip) treated by replacement.
* Patients who mentioned they agree for scientific use of their medical data.

Exclusion Criteria:

* Patients hospitalized only for the second surgery of a two-stage replacement.
* Patients who refused or didn't agree with scientific use of their medical data.
* Adults with legal protective measures.
Ph II Cabazitaxel DD Liposarcoma

Soft tissue sarcomas (STS) are a rare group of malignant heterogenous tumors (\> 50 histological subtypes, including liposarcoma, the commonest subtype of STS) with distinct genetic, pathological and clinical profiles, and varying patterns of tumor spread. The optimal cytotoxic treatment for this group of patients remains uncertain. Single agents which are most effective include doxorubicin and ifosfamide, but objective response rates and progression-free survival times remain modest. There is clearly a need to improve treatment options for liposarcoma. Eribulin, a antimicrotubule agent that targets the protein tubulin in cells, interfering with cancer cell division and growth , has demonstrated activity in STS. Therefore, it is reasonable to explore whether other anti-microtubule agent like cabazitaxel have a role in STS. Cabazitaxel has been shown to be a relatively safe, effective and tolerated. This drug has been approved by FDA for prostate cancer. The main objective of this trial is to determine whether cabazitaxel demonstrate sufficient antitumor activity for liposarcoma.


Eligibility Criteria:
Inclusion Criteria:

* Local diagnosis of dedifferentiated liposarcoma
* Age 18-75 yrs
* WHO performance status 0-1
* Radiological or histological diagnosis of inoperable locally advanced or metastatic disease, with evidence of disease progression within the past 6 months
* Clinically and/or radiographically documented measurable disease within 21 days prior to randomization.At least one site of disease must be unidimensionally measurable according to RECIST 1.1.
* One previous chemotherapy regimen for locally advanced or metastatic dedifferentiated liposarcoma (this could include pre-operative chemotherapy for primary disease if subsequent complete resection was not achieved).
* Adequate haematological, renal and hepatic function
* Birth control measures
* Estimated life expectancy \> 3 months
* Related adverse events from previous therapies ≤ Grade 1
* Written informed consent

Exclusion Criteria:

* More than 1 prior molecularly targeted therapy (e.g. CDK4 inhibitor). Any prior such therapy must be completed at least 4 weeks before randomization.
* Symptomatic CNS metastases
* Previous encephalopathy of any cause or other significant neurological condition
* Concurrent or planned treatment with strong inhibitors or inducers of cytochrome P450 3A4/5
* Pregnancy
* inflammation of the urinary bladder (cystitis)
* Other invasive malignancy within 5 years (exceptions of non-melanoma skin cancer, localized cervical cancer, localized and presumably cured prostate cancer or adequately treated basal or squamous cell skin carcinoma)
* Significant cardiac disease
* Uncontrolled severe illness or medical condition, other than DD liposarcoma
* Hypersensitivity to taxanes or their excipients
Clinical and Immunological Outcomes of Living and Deceased Donor Transplantation

This is a retrospective, prospective, single-centre, non-pharmacological observational study.

The primary objective is to investigate the long-term prognosis of the kidney transplant function of different types of donors.

It provides for the systematic collection of clinical information of patients undergoing kidney transplantation from 01/01/2017 until the Ethics Committee approves the study and the Director General of the IRCCS issues the authorisation. Data collection will continue for 9 years after the start of the study.

Patients participating in the prospective part will be treated according to clinical practice, in accordance with the judgement of the physician and the information reported in the Technical Data Sheet of each individual product of any concomitant therapies administered according to clinical practice. There are no additional study-specific visits/examinations for enrolled patients and any data recorded for the purposes of the study is collected for care purposes during the patient's normal course of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years.
* Kidney transplant recipient from any donor.
* Acquisition of Informed Consent to study participation and data processing.

Exclusion Criteria:

-
Comparison of Extremely Obese Patients Undergoing Gastric Sleeve Surgery

By the comparison of the preoperative and postoperative data of approximately 160 patients undergoing gastric sleeve surgery, we try to draw conclusions about the effectiveness of gastric sleeve surgery, expected complication rate.

We plan to compare the preoperative and postoperative data of approximately 160 patients undergoing gastric sleeve surgery (android-gynoid, male-female, comparison of patients with different degree of obesity, age comparison, etc.) Many preoperative and postoperative data are known about the patients (weight, height, BMI, preoperative comorbidities, heart ultrasound values, respiratory function values, laboratory parameters, smoking habits, rate of weight loss in half a year and one year, etc.). By statistical analysis of these data, we try to draw conclusions about the effectiveness of gastric sleeve surgery, expected complication rate, etc.,

Eligibility Criteria:
Inclusion Criteria:

Obesity (BMI higher than 30 kg/m2)

Exclusion Criteria:

Lack of patient consent to the study, Pregnancy
A Comparative CT Evaluation of the Amount of Root Resorption in Self-ligating Versus Conventional Brackets

Aim: The aim of the study was to evaluate and compare the extent of root resorption in the maxillary and mandibular anterior teeth during orthodontic treatment with the use of different types of brackets. Materials and methods: The study consisted of 21 patients (11 males and 10 females) within the age group of 16-25 years, having bimaxillary protrusion. They were divided into three groups. In Group 1- Conventional brackets, Group 2- Self-ligation brackets:Smart Clip (Passive), and in Group 3 Self-ligation brackets: Empower (Active) were bonded. Computed Tomography scans and Orthopantomograms were taken before start of treatment and after six months of retraction. Root resorption is computed as the difference between the pre treatment total tooth length and the post treatment total tooth length.


Eligibility Criteria:
Inclusion Criteria:

- Patients having complete root formation at start of treatment,

Exclusion Criteria:

* Patients with skeletal or dental anomalies .
* Patients having history of root resorption
* Patients having any systemic or metabolic anomalies,
* Patients with trauma of anterior teeth
* Patients with periapical inflammation of the anterior teeth
* Patients with impacted teeth
* Patients with tumors and cysts in the examined area
* Patients having undergone orthodontic treatment previously.
Ready, Set, Go! A Physical Fitness Intervention for Children With Mobility Challenges

Barriers to keeping and maintaining fitness as a young person with a disability exist across many domains of access to community locations such as fitness centers, so looking outside of these establishments may be necessary to advance fitness. This study is aimed at piloting a program that would address some of these barriers by hosting a modified after school running program with an underserved population in an accessible way. There is a second option to participate outside of school.


Eligibility Criteria:
Inclusion Criteria:

* a medical diagnosis (for example, cerebral palsy) that causes them mobility limitations

Exclusion Criteria:

* concurrent medical condition that would make exercise unsafe,
* are unable to follow simple commands
* have behaviors that would potentially compromise safety of fellow runners or caregivers
Safety and Pharmacokinetics of Besylsartan Tablet in Healthy Male Subject

This clinical trial was evaluated to compare the safety and pharmacokinetics of Besylsartan with Amosartan, which was available commercially after single oral dose in healthy male subjects.


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) between 18 and 30
* Healthy as determined by a responsible physician

Exclusion Criteria:

* History of clinically significant disease
* Any chronic disease
* Creatine clearance less than 50ml/min
* Hypotension (100mmHg/60mmHg)
* Treatment of barbital type drug within 1 month
* Administration of herbal medicine within 7 days
Fentanyl Sublingual Spray and Fentanyl Citrate Intravenous (IV) in Opioid Naive Subjects

The primary objective of this study is to determine the pharmacokinetic and pharmacodynamic relationship of a single dose of fentanyl sublingual spray in opioid naive subjects. The secondary objective is to determine the safety and tolerability of fentanyl sublingual spray in opioid naive subjects.


Eligibility Criteria:
Inclusion Criteria:

* Meets protocol-specified criteria for qualification and contraception
* Willing and able to remain confined in the study unit for the entire duration of each treatment period and comply with restrictions related food, drink and medications
* Voluntarily consents to participate and provides written informed consent prior to any protocol-specific procedures

Exclusion Criteria:

* History or current use of over-the-counter medications, dietary supplements, or drugs (including nicotine and alcohol) outside protocol-specified parameters
* Signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:

  1. the safety or well-being of the participant or study staff
  2. the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding)
  3. the analysis of results
Investigating the Influence of Age and Saliva Flow on the Perception of Protein Fortified Foods and Beverages

Brief Summary: This study aims to investigate whether protein fortification of foods and beverages causes mouthdrying and mucoadhesion and whether this is influenced by age and saliva flow.

To investigate whether whey protein beverages cause mouthdrying in older adults and if perception and acceptance are influenced by repeated consumption, age and individual differences in saliva flow.

To investigate whether protein fortification of cupcakes causes mouthdrying and if perception and acceptance are influenced by repeated consumption, age and individual differences in saliva flow in a home environment.

To investigate whether mucoadhesion is present within different food models, if sensitivity to mucoadhesion increases with age and to determine if a reduced salivary flow results in strengthened mucoadhesion.

Eligibility Criteria:
Inclusion Criteria:

* Age (18-30 years or over 65 years)
* Healthy

Exclusion Criteria:

* Cognitively impaired
* Allergies, intolerance and special dietary requirements (for example coeliac disease, lactose / gluten intolerance)
* Suffer from diabetes
* Oral surgery
* Stroke
* Smoker
* Cancer
Improving Osteoporosis Care in High-Risk Home Health Patients

SPECIFIC AIMS: We propose a three-year study to develop a high-intensity intervention to improve osteoporosis care and test a novel intervention in a group-randomized trial of 27 home health offices and 1,000 patients referred to home health care with a history of fracture.

Aim 1. Develop an intervention to promote osteoporosis treatment that includes: (1) training to enhance nurse-patient and nurse-physician risk communication regarding osteoporosis and fracture risk; (2) automated prompts within the home health agency's electronic medical record system to promote appropriate osteoporosis management; and (3) implementation of osteoporosis-related standardized care pathways and order sets.

Aim 2. Conduct a group-randomized trial to test the effectiveness of the intervention to promote initial use of osteoporosis medications and adherence to treatment after discharge from home health. We hypothesize that:

H1: Patients in the intervention group will have increased initial receipt of osteoporosis prescription medications and calcium/vitamin D supplements to prevent and treat osteoporosis compared to patients receiving usual care; H2: Patients in the intervention group will demonstrate increased persistence in the use of these therapies compared to those receiving usual care.

Secondary Aims (SA) will include exploratory analyses of fracture related morbidity and mortality, patient-reported quality of life, and health services utilization and costs.


Eligibility Criteria:
Inclusion Criteria:

* Patients will be identified as "at-risk" if they are referred to home health care for post-fracture care or if they are admitted for another reason and have a previous diagnosis of fracture.

Exclusion Criteria:

* Patients in hospice, with a life expectancy \< 1 year, over 95 years old, or with concomitant metabolic bone diseases (e.g. Paget's disease of bone) will be excluded.
Pregnane X Receptor (PXR) Agonist Rifampicin Effects on Glucose, Lipid and Hormone Homeostasis

This clinical trial is designed to study the effects of rifampicin on the glucose, lipid and hormone homeostasis in healthy volunteers. The main hypothesis is that rifampicin lowers fasting glucose and enhances insulin sensitivity. The study is a randomized, placebo-controlled, open-label cross-over trial. Twelve subjects will be given 600 mg of rifampicin a day for a week compared to a one-week placebo arm. There is at least a 4-week wash-out between the arms. The main outcome measures are the changes in the fasting glucose and HOMA-IR-index (calculated based on fasting glucose and insulin).


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteer
* Age 18-40 years

Exclusion Criteria:

* Any continuous medication
* Any significant disease
* Allergy to rifampicin
* Pregnancy and breast feeding
* Fear of needles and previous difficult blood samplings
* Substance abuse
* Participation in another clinical drug trial within 1 month of enrollment
* Use of soft contact lenses
Oral Human Papillomavirus Infection in HIV-infected Men

Human papillomavirus (HPV)-infection belong to the most common sexually transmitted diseases worldwide. HIV-infected men having sex with men /MSM) are strongly associated with a higher prevalence of genitoanal HPV-infection, and perianal HPV-infections have been detected in up to 90% of HIV-positive men. The data concerning the incidence of oral HPV-infection in HIV-positive men, especially in the era of highly antiretroviral therapy, are conflicting. Thus, this prospective study mainly focuses on the incidence and prevalence of oral HPV-infection, spectrum of HPV-types, and oral high-risk HPV viral load in HIV-positive men.

Human papillomavirus (HPV)-infection belong to the most common sexually transmitted diseases worldwide. Estimated prevalences of subclinical genital HPV-infection in the immunocompetent sexually active population range from 10 to above 50%. Genetic or iatrogenic immunosuppression is known to play a decisive role in the initiation of a variety of cutaneous neoplasias and their precursor lesions. In this context, HPV-associated anogenital malignancies occur with high frequency in patients with HIV-infection. In several studies, perianal HPV-infections have been detected in up to 90% of HIV-positive men and a high incidence of anal dysplasia has been reported in these patients. The data concerning the incidence of oral HPV-infection in HIV-positive men, especially in the era of highly antiretroviral therapy, are conflicting. Thus, this prospective study mainly focuses on the incidence and prevalence of oral HPV-infection, spectrum of HPV-types, and oral high-risk HPV viral load in HIV-positive men.

Eligibility Criteria:
Inclusion Criteria:

* HIV-infected men who have sex with men

Exclusion Criteria:

* None
TAKE Steps: Motivational Interviewing to Prevent STIs

This study will consist of a randomized controlled trial of a motivational interviewing intervention for adolescents with diagnosed sexually transmitted infections (STIs). The sessions will provide HIV/STI prevention education, use motivational interviewing (MI) to enhance goal setting, and providing skill building and referral to evidence based STI and HIV prevention strategies Pre-Exposure Prophylaxis (PrEP), condom use, and partner notification.

Pilot phase: Pilot testing will occur over a 3-month period to prime intervention for implementation, with the aim of recruiting n=10 pilot participants. Pilot phase participants will follow the same study procedure timeline as participants randomized to the MI intervention arm of the randomized control trial (RCT), excluding the 6-month follow-up visit. Pilot participants will not be followed in the RCT or contribute outcome data. At the end of every intervention visit in the pilot phase (the baseline, 1-week, 1-month and 3-month visits), participants will complete a brief feedback interview to ensure face validity and identify areas needing refinement. Feedback will be incorporated into the study design, with amendments submitted to the Institutional Review Board (IRB) as needed. Data from pilot participants will not be included in analysis of the RCT.

Intervention phase:The RCT will randomize youth with recent STI 2:1 to the TAKE Steps intervention vs a standard of care (SOC) control. Both arms (intervention and SOC) will have data collection visits at the baseline, the 3-month, and the 6-month-follow-up time points. In addition, the intervention group will have intervention sessions at baseline, 1 week, 1 month and 3 months.

The study treatment phase for the RCT will consist of data collection and motivational interviewing sessions over a 6-month period. Intervention sessions will consist of HIV and STI prevention education, motivational interviewing, skill building, and referral to therapy.

All visits can occur in-person or remotely.

Eligibility Criteria:
Inclusion Criteria:

* Males or females aged 13 to 19 years.
* History of ≥1 STI in the 30 days prior to recruitment
* Confirmed treatment for a laboratory confirmed diagnosis of Trichomonas vaginalis (via microscopy or nucleic acid amplification test \[NAAT\]), Neisseria gonorrhea (NAAT), Chlamydia trachomatis (NAAT), Treponema pallidum \[via new positive rapid plasmin reagin (RPR) assay\] within the prior 30 days
* Self-reported HIV negative status.
* Able to speak and understand written English

Exclusion Criteria:

* Unable to provide informed consent due to intoxication or severe psychological distress.