cyrilzakka/clinical-trials huggingface dataset:
Quantitative and Clinical Assessment of Flexor Tendon Gliding Following Application of a Bioresorbable Hydrogel: A Prospective, Randomized Study in Patients Undergoing Distal Radius Fracture Repair

The investigators will be evaluating the use of versawrap in the setting of distal radius fractures by placing membrane between plate and flexor tendons. Investigators will then evaluate tendon gliding morphology and number of tendon ruptures


Eligibility Criteria:
Inclusion Criteria:

* Cognitively able to converse in English or in native language supported by a certified medical interpreter;
* Diagnosed with a closed, distal radius fracture treated with open reduction and internal fixation using a volar distal radius plating system.

Exclusion Criteria:

* open injury;
* concomitant injury to the contralateral wrist;
* history of flexor tendon repair involving one or both hands or wrists;
* use of a trans-carpal fixation device (bridge plate or external fixator) that would preclude wrist motion post-operatively;
* concomitant fracture / injury to the thumb or index finger of one or both hands;
* concomitant carpal tunnel release.
A Phase 3 Open Label Extension Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia

The primary objective of this study is:

• To evaluate the long-term safety of fostamatinib in subjects with warm antibody autoimmune hemolytic anemia (wAIHA).


Eligibility Criteria:
Inclusion Criteria:

1. Subject must be willing and able to give written informed consent by signing an IRB approved Informed Consent Form prior to undergoing any study-specific procedures.
2. Subject must have completed all 24 weeks of participation in the study C-935788-057.

Exclusion Criteria:

1. Any subject who discontinued participation in Study C-935788-057 prior to Week 24.
Trial of Small Intestine Submucosa (SIS) Mesh for Anterior Repair: A Pilot Study

Prolapse occurs when pelvic organs drop down and cause a bulging of the tissues. An "anterior wall prolapse" occurs when the front of the vagina loses its support, and the bladder drops down and rotates into the vaginal opening. The bladder can cause a bulge out of the vagina.

One of the treatment options available is to repair the anterior wall surgically. The goals of surgery are to return the anatomy to its usual position, ensuring that all the pelvic floor organs (bladder, vagina and rectum) can function properly. The ideal surgical repair would also be long lasting.

Two surgical options are routinely performed in Calgary for repair of an anterior compartment prolapse. One option involves fixing the organs back in place using sutures. The other option uses sutures plus a mesh made of small intestine submucosa (SIS) that is already licensed for use in Canada. The SIS mesh is slowly absorbed after it is placed in the pelvic area. The investigators do not know which of these two options is the best surgical procedure. Both may have different advantages that would result in better results. This study is designed to try and find out if one of these procedures is better, and if a larger study may be needed.


Eligibility Criteria:
Inclusion Criteria:

* Women who require surgical correction for anterior compartment prolapse. (Concomitant surgery is permitted.)
* Point Ba of 0 or greater: that is a positive Ba, indicating that the prolapse is beyond the introitus, not within the vagina.
* Patient must consent to participate in the study.

Exclusion Criteria:

* Having an obliterative procedure (Lefort procedure or colpocleisis).
* Allergy to graft material.
* Immunocompromised.
* Previous anterior compartment repair.
* Are unable to understand English.
* Will be unavailable for follow-up.
European Trial of Immunosuppression in SPK Tx

1. To determine and compare the efficacy of Tacrolimus/Rapa versus Tacrolimus/MMF-based immunosuppression (in conjunction with initial short-term steroids and polyclonal antibody administration) in Type 1-diabetic patients undergoing simultaneous pancreas/kidney allograft transplantation.
2. To evaluate the safety of Tacrolimus/Rapa versus Tacrolimus/MMF in terms of drug-related complications and overimmunosuppression-associated complications, particularly under monitoring of the pharmacokinetic profile of all drugs administered.

This will be a controlled, randomised study, to be performed in 15-20 pancreas transplantation centers throughout Europe. Patients will be randomised into one of two treatment groups. Group 1 will receive Tacrolimus and Mycophenolate Mofetil (= best group in EuroSPK001 trial). Group 2 will receive Tacrolimus and Sirolimus. Both groups will receive in association short-term corticosteroids and polyclonal antibody preparation. Patients will be randomly assigned to one of the 2 treatment groups in a 1:1 ratio before transplantation. The study will last 3 years, with a first interim analysis of the data at 6 months and a complete analysis at 1 year.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients, of 18 to 55 years of age, with end-stage, C-peptide-negative, Type 1-diabetic nephropathy.
2. Female patients of childbearing age must have a negative pregnancy test and must agree to maintain effective birth control practice throughout the study period (3 years).
3. Patient must have signed the Patient Informed Consent Form.
4. Patient must receive a primary simultaneous pancreas/kidney (SPK) cadaveric transplant, with either intestinal or bladder and either portal or systemic venous drainages.

Exclusion Criteria:

1. Patient is pregnant or breastfeeding.
2. Patient is allergic or intolerant to Mycophenolate Mofetil, Sirolimus, Tacrolimus or other macrolides, or any compounds structurally related to these compounds.
3. Patient has a positive T-cell crossmatch on the most recent serum specimen.
4. Patient is known for active liver disease or has significant liver disease, defined by ASAT and ALAT serum levels greater than 3 times the upper limit of normal.
5. Patient has malignancy or history of malignancy, with the exception of adequately treated localised squamous cell or basal cell carcinoma, without recurrence.
6. Patient has been included in another clinical trial protocol for any investigational drug within 4 weeks prior to randomisation.
7. Patient has any form of substance abuse, psychiatric disorder or condition, which, in the opinion of the investigator, may invalidate communication.
8. Patient receives a SPK transplant from a living donor, or receives segmental pancreatic transplant, or a previous kidney transplant alone.
9. Pancreatic duct occlusion technique .
10. Donor is older than 55 years of age.

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Evaluate Relative Bioavailability of PA32540 (Asa/Omeprazole), Its Aspirin Component, and Ecotrin® in Healthy Volunteers

Study to determine a single dose bioavailablity of PA32540 is similar to EC aspirin 325 mg with respect to salicylic acid.


Eligibility Criteria:
Inclusion Criteria:

* Standard for PK
* Ages 18-55 years old
* Males and females

Exclusion Criteria:

* Standard for PK
A Study of CM310 in Subjects With Moderate to Severe Asthma

This study is a multi-center, randomized, double-blind, placebo-controlled Phase II clinical study to evaluate the efficacy, safety, PK characteristics, PD effects and immunogenicity of CM310 in subjects with moderate to severe asthma.

The study consists of three periods, including an up to 4-week screening period, a 24-week randomized treatment period, and a 8-week safety follow-up period.


Eligibility Criteria:
Inclusion Criteria:

* Subjects are able to understand the nature of the study and voluntarily sign the ICF.
* Diagnosed with asthma according to the 2021 version of the GINA guidelines for at least 1 year.
* Pre-bronchodilator FEV1 measurement ≤ 80% of predicted normal value.
* Subjects must have experienced a severe asthma exacerbation within 12 months prior to screening, and have not experienced a severe asthma exacerbation within 1 month prior to screening.

Exclusion Criteria:

* Women of childbearing potential have a positive pregnancy test result during the screening period; women who are pregnant or lactating.
* Received biologics with the same therapeutic purpose within 6 months prior to screening, such as similar IL-4Rα antagonist, IL-5/5R, anti-IgE monoclonal antibody (mAb).
* Diagnosed with chronic obstructive pulmonary disease (COPD) or other lung disorders that may compromise lung function (including but not limited to idiopathic pulmonary fibrosis, allergic granulomatous angiitis, bronchopulmonary aspergillosis allergic, pulmonary tuberculosis, etc.).
Safety and Efficacy of Oshadi D and Oshadi R in Basal Cell Carcinoma Patients Prior to Tumor Excision a Phase 2 Study

This study is single-arm, none randomized, open label, two-dose-cohorts, single center clinical trial for evaluation of the safety and efficacy of Oshadi D and Oshadi R in patients with BCC. Patients will receive Oshadi D and Oshadi R for 60 -90 days until the planned surgical excision of the lesion.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 21 years old with tissue confirmed diagnosis of local BCC.
* Patient is candidate for surgical excision of the BCC in few months.
* BCC lesion ≥10mm in its longest diameter.
* Sexually active fertile patients and their partners must agree to use medically accepted methods of contraception during therapy and 3 months after the last dose of the study drugs.
* Female patients of childbearing potential must have a negative pregnancy test at screening.
* Patient must understand and be willing to give written informed consent prior to any study procedures or evaluations and be willing to adhere to all study schedules and requirements.

Exclusion Criteria:

* Uncontrolled Intercurrent illness or any history of significant cardiac, renal, neurologic, metabolic, pulmonary, gastrointestinal, hematologic abnormality, chronic hepatic disease or any other disease which in the judgment of the investigator would interfere with the study or confound the results.
* Other active cancer disease.
* Serum creatinine \> 1.5 mg/dL for males and \>1.4 mg/dL for females.
* Female patient who are breastfeeding or have a positive pregnancy test at screening or at any time during the study.
* Any acute cardiovascular event during the last 6 months prior to inclusion.
* Symptomatic congestive heart failure with ejection fraction \< 30%.
* Patient has prothrombin time/International Normalization Ration (PT/INR) or partial thromboplastin time (PTT) test results \> 1.3 UNL.
* Hemoglobin ≤ 11 g/dL
* Platelets \< 150,000 per microliter
* White blood cell count\<3,000 x109/L and/or absolute neutrophils count \<1.5 x 109/L
* Significant swallowing disorders.
* History of small bowel surgery.
* Any history of pelvic or abdominal radiation.
* Pre-existing mal-absorption syndrome, irritable bowel syndrome or other clinical situation which could affect oral absorption.
* Mental disorders.
* Inability to give written informed consent.
Assessment of the Potential Interactions Between Cocaine and GBR 12909 - 1

The purpose of this study is to assess the potential interactions between iv cocaine and GBR 12909.

This is a single dose with escalation, double-blind, placebo-controlled inpatient study in which 24 cocaine experienced volunteers that meet protocol eligibility criteria during a 30 day screen period will be randomized into three dose groups.

Eligibility Criteria:
Inclusion Criteria:

* Must understand study procedures and provide written informed consent
* For additional inclusion criteria information, please contact study site for more information.

Exclusion Criteria:

* Please contact study site for more information.
Peri-implant Bone Behaviour Using Two Drilling Techniques in Posterior Maxilla

Two different drilling techniques in posterior maxilla immediate loading implant

One of the surgical techniques used to enhance the primary stability of implant in low density bone was the undersized drilling technique, which has been introduced to locally optimize poor density of bone by using a final drill diameter considerably smaller compared with the implant diameter.

On the other hand, a novel hollow drill with a single drilling systems was designed. Single drilling technique shortens surgical times, removes the smallest amount of bone during implant site preparation, reduces bone damage and micro fractures, and speeds up the healing process. Additionally, because of the hollow shape, bone core may be harvested and used as an autogenous bone grafting material.

Eligibility Criteria:
Inclusion criteria:

1. Patients with missing single or multiple teeth in posterior maxilla.
2. Age more than 18 years.
3. 10 mm or more vertical bone height is present.
4. Good oral hygiene.
5. Patients willing to be present during the study follow up intervals.
6. Patients free from any systemic diseases.
7. 6 mm or more ridge width is present.
8. Crown height space of at least 8 mm.
9. Patients without any para-functional habits (bruxism and clenching).

Exclusion criteria:

1. Patients with any pathological lesion or root tips at the planned surgical site.
2. Patients with inadequate bone height and thickness.
3. Smoking more than 14 cigarettes per day.14
4. Alcohol or drug abuse.
5. Patients with systemic diseases that absolutely contraindicate implant placement.
The Effect of Administration on N-Acetylcysteine on Serum Creatinine Levels in Patients With Chronic Kidney Disease

Primary outcome: Serum creatinine change at 4 hours and 48 hours following 4 doses of N-acetylcysteine (total 4800 mg) compared to baseline serum creatinine.

Secondary outcome: Serum Cystatin C change at 4 hours and 48 hours post 4 doses of N-acetylcysteine compared to baseline serum Cystatin C.

N-acetylcysteine has been reported to lower serum creatinine in normal individuals. The mechanism of this effect is unknown but possible stimulation of tubular secretion of creatinine has been hypothesized based upon a lack of effect on Cystatin C levels. If this effect also occurs in subjects with chronic kidney disease, interpretation of clinical trials using N-acetylcysteine for prophylaxis of acute kidney injury would be confounded. To answer whether such confounding occurs, 50 patients with stable chronic kidney disease (Stage 3-5) will be given 4 doses of N-acetylcysteine, 1200 mg each, with measurement of serum creatinine and Cystatin C before, 4 hours and 48 hours after the last dose. No other interventions, including changes in medications, will be permitted during the study.

Eligibility Criteria:
Inclusion Criteria:

* Estimated GFR 10-59 ml/min/1.73m2 by 4 variable MDRD equation
* Less than a 10% difference between the baseline creatinine and the recruitment creatinine obtained within 3 months of the trial

Exclusion Criteria:

* Unable to give informed consent
* Unwillingness to return for follow-up blood sampling
* Unstable renal function
* Subjects taking H2-blockers
Respiratory Muscles and Inspiratory Muscle Training

The effects of inspiratory muscle training (IMT) remain controversial. Many studies have examined the effect IMT has on exercise performance, but any changes to the body that come from IMT have yet to be looked at.

This study will look at how someone breathes can change after IMT. Understanding how IMT changes the body can help us use IMT in different treatments.


Eligibility Criteria:
Inclusion Criteria:

* Recreationally active, 'Moderate' or 'High' category on International Physical Activity Questionnaire Short form questionnaire
* Able to read and understand English
* Pulmonary function within normal limits

Exclusion Criteria:

* History of or currently smoking
* History or current symptoms of cardiopulmonary disease (including asthma and exercise induced asthma)
* Currently participating and training in a sport at a provincial, national, or international level
* Ulcer or tumor in the esophagus, a nasal septum deviation, or recent nasopharyngeal surgery
* Allergies to latex or local anesthetic
* Contraindications to exercise testing
Mediators and Moderators of Exercise Behavior Change

Rates of cancer and cardiovascular disease have shown very little improvement over the past two decades, and the incidence of Type II diabetes mellitus is increasing at an alarming rate. Recent reports estimate that approximately 30% of total cancer deaths are related to poor exercise and nutrition, and other reports have suggested that, when taking into consideration both cardiovascular disease and cancer, inactivity contributes to as many as 250,000 premature deaths per year (Booth et al., 2002). Despite the benefit of regular physical activity in the prevention of cancer and other debilitating illnesses, 75% of the U.S. population do not get the recommended amount of physical activity as defined by 30 minutes of moderate intensity physical activity 5 or more days per week (CDC, 2001), and 40% of the population is completely sedentary (USDHHS, 19960. The objective of the proposed research is to understand the mediators and moderators of a well-tested individually tailored, print-based intervention to increase exercise behavior among sedentary adults. Using a randomized, controlled intervention ton trial, the proposed study will address three primary and one secondary hypotheses: 1) A previously tested and validated exercise promotion intervention (c.f., Marcus et al., 1998) is successful at helping sedentary individuals initiate and maintain a moderate intensity physical activity regimen, as compared to a health and wellness control intervention, 2) Increases in positive attitudes, perceived normative support, self-efficacy, and intentions to exercise will mediate the effectiveness of the intervention, 3) That increased positive mood, and better temperature, stress, and lactate regulation immediately after exercise challenge (assessed in the laboratory) will moderate the effectiveness of the intervention, and 4) Secondarily, we will test whether gender, race/ethnicity, and two recently suggested genetic factors (BDNF and OPRM1) moderate the effectiveness of the intervention. The rigorous assessment of how and for whom an exercise promotion intervention is effective will provide information for future development of intervention strategies and content, as well as allow the targeting of exercise content to individuals for whom it is most likely to be effective.


Eligibility Criteria:
Inclusion Criteria:

* All participants were required to exercise less than 90 minutes per week on average, have a body mass index (BMI) between 18 and 37.5, be physically capable of engaging in moderate-intensity physical activity, have a regular menstrual cycle (if female), be willing to be randomly chosen for one of the two interventions, and give informed consent.

Exclusion Criteria:

* Individuals were excluded if they smoked cigarettes, were on a restricted diet, taking psychotropic medications, receiving treatment for any psychiatric disorder, diabetic, had a history of cardiovascular or respiratory disease, had the flu or illness in the previous month, or were pregnant (if female).
Aberrant Gene Expression Prostate Carcinoma

The goal of the study is to gain a better understanding of the molecular changes responsible for causing prostate cancer and that examination of tissue and blood samples will help in the development of improved screening and therapeutic approaches.

The goal of this study is to identify novel genetic elements that are aberantly expressed throughout prostatic neoplastic progression. The approaches proposed exploit the known familial arm of prostatic cancer, using established molecular genetic approaches, and extend these studies to sporadic prostatic cancer using a novel technique of differential display. Application of the latter technique to colon cancer in the American population establishes this tumor type as a high priority for scientific investigation and this study is part of an initiative to address this problem. Presently the studies in the field of prostate are under-represented. The collection of tissue samples from patients diagnosed with prostate cancer. Patients will also provide a blood sample at the time of their surgery and potentially post-op from 6 mos to 5 years. Samples will also be obtained from patients who's biopsy turns out to be non-prostate cancer. These samples will be obtained shortly following the biopsy out to 6 months after the biopsy.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed prostate cancer undergoing prostatectomy
* Suspicion of prostate cancer undergoing biopsy - negative biopsy
* Health volunteer (control group) - blood sample for PSA

Exclusion Criteria:

* Patients not fitting the inclusion criteria
A Study of Trifluridine/ Tipiracil in Chemorefractory mCRC in Greece

Collection of real world data on the clinical efficacy of trifluridine/ tipiracil (FTD/TPI) in the Greek population.

The aim of this analysis is to record clinical practice and to collect real world data on the clinical efficacy of trifluridine/ tipiracil (FTD/TPI) in the Greek population. Main objectives include to assess physician's choice of treatment in chemoresistant metastatic colorectal cancer with FTD/TPI in third line and beyond In addition, the clinicopathologic features related to metastatic colorectal cancer (focus on molecular profile), duration of treatment, dose modification and toxicity will be analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Histologically confirmed metastatic colorectal cancer
* Available data on previous chemotherapy lines

Exclusion Criteria:

No exclusion criteria have been established for this observational and retrospective study.
Continuous Suturing Versus Interrupted Clips for Brachiocephalic AV Fistula Creation

The purpose of this study is to investigate a promising strategy to improve maturation and patency rates following creation of AV fistulas and assess whether an anastomosis performed with Anastoclips (interrupted, nonpenetrating) would produce better maturation and/or patency than one performed with conventional suturing techniques.

This will be a single blind (patient and dialysis center), prospective, randomized trial conducted at a single center. The study intervention will be randomization between conventional sutured anastomosis (Control group) and use of Anastoclips (Treatment group), which provide an interrupted closure without intimal penetration.

Eligibility Criteria:
Inclusion Criteria:

* Requiring brachiocephalic fistula judged to be best option for access after vein mapping (Surgeons will be required to do 10 cases using Anastoclips prior to enrolling)
* Able to provide informed consent in English or Spanish
* Age 18 years or greater
* With estimated life expectancy of 2 years or more
* Able to comply with study procedures including all scheduled follow-up visits

Exclusion Criteria:

* Unable to provide informed consent in English or Spanish
* Age \< 18 years
* With pacemaker, IACD, or other permanent obstructive device on that side (a temporary tunneled dialysis catheter is not an exclusion)
* Unable (or in surgeon's judgment a poor risk) to comply with study procedures and follow-up visits
* With estimated life expectancy of less than 2 years
* Females must be either:

  * Of non-childbearing potential, which is defined as post-menopausal (at least 12 months without menses prior to Treatment Day) or documented surgically sterile or post hysterectomy (at least 1 month prior to Treatment Day)
  * Or, of childbearing potential, in which case must have a negative urine pregnancy test at Treatment Day