cyrilzakka/clinical-trials huggingface dataset:
Comparison of Two Bipolar Resector in Less Than 3cm Myoma Resection

Hysteroscopic resection of type 0, 1 or 2 myoma is frequent. The more frequent resector used for myoma resection is 26Fr hysteroscope. Actual miniaturization of resector led to 18.5Fr resector with a potential benefit because of less dilatation. These resectors are often used but no scientific evaluation has been performed.

Hypothesis of this non inferiority trial is that complete resection in a unique surgical time will be comparable with both resectors.

Myoma type 0, 1 or 2 are often symptomatic (abnormal uterine bleeding or infertility) and hysteroscopic resections are thus frequent. This management is a minimally invasive surgery.

Usually, a 26Fr resectoscope is used and the main articles on this topic report hysteroscopie resections with a 26Fr resectoscope. Miniaturization of resector led to decrease in the size of resectors with a potential benefit because of a less important cervical dilatation and then a smaller risk of adverse events and an increase in the number of surgery under local anaesthesia.

Use of 18.5Fr resectors is more and more frequent but, to our knowledge, it has never been evaluated for benefit on cervical dilatation but also for rate of complete resection in one time, surgical length and rate of unbalanced input/output.

Intuitively, a smaller diameter could led to a less traumatic cervical dilatation but it could also led to an higher risk of incomplete treatment in one time and a longer surgical duration and a more frequent unbalanced input/output.

No study compare use of these two resectors (18.5 and 26Fr) all the more randomized. With 26Fr resector, the rate of complete resection in one time for less than 3cm myoma is around 90%. If this rate is higher with the 18.5Fr resector, the risk/benefit balance (including economic evaluation) won't be favorable to this use.

Eligibility Criteria:
Inclusion Criteria:

* Older than 18 years old
* With a type 0,1 or 2 unique myoma requiring surgery

Exclusion Criteria:

* No medical care
To Demonstrate the Relative Bioavailability of Geneva and Dista (Prozac) 20 mg Fluoxetine Hydrochloride Capsules (Pulvules) In Healthy Adult Males Under Fasting Conditions

To demonstrate the relative bioavailability of Geneva and Dista (Prozac) 20 mg Fluoxetine Hydrochloride capsules (Pulvules) in healthy adult males under fasting conditions.


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria:

* Positive test results for HIV or hepatitis B or C.
* Treatment for drug or alcohol dependence.
Efficacy and Safety Study of 4975 to Manage Pain of Bunionectomy

The primary purpose of this study is to compare the analgesic efficacy of a single intraoperative administration of 4975 vs. Placebo in the management of acute postoperative pain in patients undergoing bunionectomy.

Secondary objective of this study is to evaluate the safety and tolerability of a single intraoperative administration of 4975.

This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study conducted in the US. A dose of 4975 will be evaluated against placebo in patients undergoing bunionectomy. Upon enrollment, patients will be randomized in a 1:1 ratio to receive either 4975 or placebo.

After the surgery, patients will be admitted to the clinical study site, where trained study personnel will monitor them for up to 48 hours. While at the clinical study site, patients will undergo safety and efficacy assessments. After discharge, patients will report pain severity daily through Day 14 via an interactive voice response system (IVRS). Also, safety and patient-reported outcome assessments will be performed at the Day 14 (Week 2) and Day 28 (Week 4) clinic visits.

Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 18 years and older.
* Planning to undergo unilateral transpositional first metatarsal osteotomy for correction of Hallux Valgus Deformity (referred to as bunionectomy in this protocol).

Exclusion Criteria:

* Use of certain medications or having a medical condition that in the investigator's opinion could adversely impact the patient's participation or safety, conduct of the study, or interfere with the pain assessments.
* Diabetes mellitus with a known HbA1C \> 9.5 or a history of prolonged uncontrolled diabetes.
* Participated in another clinical trial or used an investigational product within 30 days prior to the planned bunionectomy surgery, or is scheduled to receive an investigational product other than 4975 while participating in the study.
* Previously participated in a clinical study with 4975.
Evaluating Quality of Life in Patients With Soft Tissue Sarcoma Presenting With Metastatic Lung Disease

The purpose of this study is to evaluate the role of palliative surgery in improving Quality of Life (QoL) and symptom control for patients who present with a Soft Tissue Sarcoma (STS) and metastatic lung disease. Responses to clinical Edmonton Symptom Assessment System - Sarcoma Modified ( ESAS-SM) questionnaire for patients who have undergone surgery for resection of the primary tumour will be compared to those that are unable to have surgery. Data collected from this questionnaire can highlight the benefits in patients' QoL who receive palliative surgical resection, and whether these benefits surmount those who are not treated with palliative surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients with soft tissue sarcoma with at least one pulmonary metastasis
* Metastatic lung disease must have been present at time of initial presentation

Exclusion Criteria:

* All patients under 18 will be excluded
* Patients who have been previously undergone surgical resection of the primary tumor
A Study to Examine the Safety, Pharmacokinetics and Pharmacodynamics of Single Dose of AMG 623 in Subjects With Systemic Lupus Erythematosus

This study is to evaluate the safety of AMG 623 in subjects with systemic lupus erythematosus. The study consists of a 21 day screening period followed by administration of the investigational product and up to 70 day follow up period.


Eligibility Criteria:
Inclusion Criteria:

* Men and women, between the ages of 18 and 55
* Diagnosis of SLE
* Have had a disease duration of at least 1 year, as diagnosed by a physician

Exclusion Criteria:

* Have a disorder (including psychiatric), condition or clinically significant disease (other than a diagnosis of SLE) that would interfere with the study evaluation, completion and/or procedures per the investigator's discretion
* Have active vasculitis, active CNS lupus requiring therapy, active acute renal disease, uncontrolled hypertension, uncontrolled diabetes or active systemic infection
* Have had signs or symptoms of viral or bacterial infection within 30 days of enrollment
* Have received a daily dose of greater than 10 mg prednisone (or equivalent) in the prior 30 days
T Cells in Predicting Acute Graft-Versus-Host Disease in Patients Undergoing Donor Stem Cell Transplant

RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors predict whether patients undergoing donor stem cell transplant will develop acute graft-versus-host disease.

PURPOSE: This clinical trial is studying T cells to see how well they help in predicting acute graft-versus-host disease in patients undergoing donor stem cell transplant.

OBJECTIVES:

* To determine the association between regulatory T-lymphocyte (Treg) subsets present at engraftment and at day 28 with the incidence of acute graft-versus-host-disease (aGVHD) in patients undergoing allogeneic stem cell transplantation.
* To identify gut-homing and skin-homing Treg subsets and determine their role during engraftment and at day 28 as a predictor of gut and skin aGVHD, respectively.

OUTLINE: Patients undergo blood sample collection at the time of neutrophil engraftment prior to stem cell transplant (SCT) and post-SCT on days 7, 14, 21, and 28 days after allogeneic stem cell transplantation. Blood samples are analyzed for T-cell subsets and for the percentage of regulatory T-lymphocyte (Treg) or other T-cell subsets expressing specific homing receptors for the gut or skin via flow cytometry.

Patients' medical records are also reviewed periodically.

Eligibility Criteria:
Inclusion criteria:

* Patients undergoing allogeneic SCT
* Age \>= 18 years

Exclusion criteria:

* Inability to give informed consent
* Patients who have not received an allogeneic SCT
* Any condition which, in the opinion of the investigator, might interfere with study objective
* Any reason which, in the opinion of the investigator, adds additional risk to the patient
Exploratory Evaluation of Flortaucipir Injection in Healthy Volunteers and Cognitively Impaired Subjects

This early phase 1 study explored the brain uptake, retention, and safety of flortaucipir and obtained preliminary information regarding dosimetry of flortaucipir.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers had an Mini-Mental State Examination (MMSE) score of ≥ 29;
* MCI due to Alzheimer's disease (AD) consistent with National Institute on Aging (NIA)-Alzheimer's Association working group's on diagnostic guidelines for AD (Alzheimer's Dementia 7:270-9, 2011)
* Possible or probable AD: Met clinical criteria for possible or probable AD based on the NIA-Alzheimer's Association working group's on diagnostic guidelines for AD (Alzheimer's Dementia 7:263-9, 2011)

Exclusion Criteria:

* Current clinically significant psychiatric disease.
* Evidence of structural abnormalities such as major stroke or mass on MRI that would have made a diagnosis of impairment due to AD unlikely or was likely to interfere with interpretation of a PET scan on MRI.
* Claustrophobic or otherwise unable to tolerate the imaging procedure.
* Current clinically significant cardiovascular disease or clinically significant abnormalities on screening electrocardiogram (including, but not limited to, corrected QT interval \>450 msec).
* Current clinically significant infectious disease, endocrine or metabolic disease, pulmonary, renal or hepatic impairment, or cancer
* History of alcohol abuse or substance abuse or dependence
* Female subjects of childbearing potential who were not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception.
* Required medications with a narrow therapeutic window
* Received a non-study related radiopharmaceutical imaging or treatment procedure within 7 days prior to imaging session
* Receiving any investigational medications or had participated in a trial with investigational medications within the last 30 days
Efficacy and Safety of Topical Cysteamine for Postinflammatory Hyperpigmentation

Post-inflammatory hyperpigmentation is a common pigmentary skin disorder that is refractory to treatment. The treatment for postinflammatory hyperpigmentation is limited. Recent studies have shown that the topical skin care product cysteamine cream has a significant decrease in melanin index without obvious side effects in other dark spots such as melasma. The goal of this study is to determine the safety and efficacy of topical cysteamine in the treatment of post-inflammatory hyperpigmentation.

Post-inflammatory hyperpigmentation is a common pigmentary skin disorder that is refractory to treatment and troublesome for darker skin individuals. The current treatment with conventional bleaching cream may result in skin irritation and ochronosis that is irreversible. Recent studies have shown that the topical cysteamine cream is safe and effective for dark spots such as melasma and lentigo with no significant side effects.

The primary aim of this study is to evaluate the safety and efficacy of topical cysteamine for postinflammatory hyperpigmentation. We conduct a randomized control, double-blinded trial to include 40 patients with postinflammatory hyperpigmentation. Clinical photography with VISIA skin imaging system,mexameter, transepidermal water loss, optical coherence tomography were used to evaluate the efficacy of treatment on a monthly basis for four months period. The patient was evaluated by two blinded investigator using the investigator global assessment. Patient global assessment was also recorded monthly.

Eligibility Criteria:
Inclusion Criteria:

* Over 20 years old
* Patients with postinflammatory hyperpigmentation for more than 3 months.

Exclusion Criteria:

* Patients with topical hydroquinone, oral tranexamic acid and/or other skin whitening agents.
* Patients that receive or planning to receive laser treatment for spot removal during the study period.
* Individuals with allergic history to cysteamine or vehicle ingredients.
* Pregnant patients or patients planning to become pregnant during the time of the study.
A New Shoulder Proprioceptive Rehabilitative Tool (SRPT) for the Evaluation of the Role of the Shoulder During Reaching

The aim of the study focused on the creation of a rehabilitative measuring device (SRPT-shoulder proprioceptive rehabilitation tool) and the development of the examination methodology for assessing the proprioception of the glenohumeral joint respect to scapula abduction, within the movement of antepulsion on the sagittal plane both in healthy subjects and in patients with shoulder impingement syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Right-handed
* Diagnosis of subacromial right impingement syndrome performed by the orthopedic specialist (nuclear magnetic resonance and/or ultrasound examination)
* Neer stages 1, 2 and 3
* Presence of pain 3 \<VAS\<8 at baseline
* Age between 55 and 65 years.

Exclusion Criteria:

* Diabetes mellitus
* Inflammatory systemic diseases
* CNS and/or PNS diseases
* Systemic infectious diseases
* Neoplastic diseases
* Assumption of antidepressants and/or anxiolytics and/or other medications that can affect attention and sensory
* Visual problems not properly compensated
* Previous surgery to the shoulder
Imatinib Mesylate in Treating Patients With Recurrent or Refractory Fibromatosis

RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase I/II trial is studying the side effects of imatinib mesylate and to see how well it works in treating patients with recurrent or refractory aggressive fibromatosis.

OBJECTIVES:

Primary

* Determine the non-progression rate in patients with recurrent or refractory aggressive fibromatosis after 3 months of treatment with imatinib mesylate.

Secondary

* Determine the non-progression rate in patients after being treated with this drug for 12 months.
* Determine the toxic effects of this drug in these patients.
* Determine the tolerance to this drug in these patients.
* Determine the response rate in patients treated with this drug
* Determine progression free and overall survival of patients treated with this drug.
* Determine the quality of life of patients treated with this drug.
* Correlate clinical, biological, and genomic markers with response and long-term stable disease in patients treated with this drug.

OUTLINE: This is a multicenter study.

Patients receive oral imatinib mesylate once daily for up to 12 months in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed periodically.

PROJECTED ACCRUAL: A total of 39 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed aggressive fibromatosis (desmoid tumor)
* Relapse or disease progression despite surgery, chemotherapy, radiotherapy, or any other treatment
* Tumors must meet the following criteria:

  * Ineligible for complete surgical resection by carcinological exeresis OR surgery would cause severe mutilation
  * Cannot be treated with curative radiotherapy
* Measurable disease by RECIST criteria
* No prior malignancy

PATIENT CHARACTERISTICS:

* Not pregnant or nursing
* Fertile patients must use effective contraception during and for 6 months after completion of study treatment
* Absolute neutrophil count \> 1,000/mm\^3
* Platelet count \> 100,000/mm\^3
* Bilirubin \< 1.5 times upper limit of normal (ULN)
* SGOT and SGPT \< 2.5 times ULN
* Creatinine ≤ 2.5 times normal
* No severe liver failure
* No chronic somatic or psychiatric illness that would preclude study compliance
* No known hypersensitivity to imatinib mesylate or one of its components
* No geographical, social, or psychological reason that would inhibit follow-up

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No concurrent immunomodulators\*
* No concurrent hormonal treatments\* if used for fibromatosis
* No concurrent cytotoxic drugs\*
* No concurrent nonsteroidal anti-inflammatory drug\* if used for fibromatosis

  * Allowed if used as an analgesic 3 months prior to disease progression
* No concurrent participation in another therapeutic investigational trial NOTE: \*If disease progression has occurred during this treatment, then the treatment must have ended ≥ 1 month prior to study entry
Endoscopic Balloon Dilation vs Surgery to Treat Short Strictures in Fibrostenosing Crohns Disease: An RCT

There is currently no standard management to guide the clinicians in treating patients with fibrostenotic disease. European Crohns and Colitis Organization \[ECCO\] recently developed a topical review on prediction, diagnosis and management of fibrostenosing Crohns disease. The review suggests endoscopic balloon dilation, strictureplasty, and intestinal resection as reasonable treatment options for short strictures based on the low grade of evidence.

Study Population All patients with Crohns disease and a short stricture (\<5 cm) within the reach of upper or lower GI endoscopy

Study Timeline

1. Pre-recruitment phase including proposal, IRB approval, staff training, budget transfer - 9 months
2. Recruitment of patients: 2 years
3. Follow up: 2 years
4. Analysis and preparing report: 6 months

Study Design Single blind randomized controlled trial The data will be blindly analyzed. Double blinding is not possible due to the nature of the study.

Study Methods Please see the study flow diagram below. Randomization will be done using computer software generating random numbers. Outcome Measures - A research associate will contact patients on weeks 1,2,4 and months 3,6,12,18 and 24 to record the items mentioned as secondary objectives of the study.

- An interim analysis will be performed after 20 cases complete the study Sample Size 40 patients randomized to two arms undergoing TTS dilation or surgical managements

Statistical analysis Comparisons between groups will be done using Student's t-test. Qualitative variables will be summarized as a percentage of the group total and comparisons between groups will be based on the chisquared test. The cumulative relapse rate of each treatment group will be estimated by the Kaplan±Meier method and the difference between treatment groups will be tested by the log rank test. Time to relapse will be compared betweens two groups using a Cox proportional hazards regression analysis. A P value of less than 0.05 is considered to be signicant.

Eligibility Criteria:
Inclusion Criteria:

* 40 Patients with Crohns disease and a short stricture (\<5 cm) within the reach of upper or lower GI endoscopy

Exclusion Criteria:

* Abscess or phlegmon
* Fistula
* High-grade dysplasia
* Malignancy
* Previous intervention
* Pregnant women
Levocetirizine Effect on Nasal Nitric Oxide and Nasal Eosinophils in Subjects With Perennial Allergic Rhinitis

The purpose of this study is to noninvasively measure the anti-inflammatory effect of levocetirizine after two weeks of treatment in allergic rhinitis subjects.


Eligibility Criteria:
Inclusion Criteria:

* ICF signed
* Diagnosis of PAR for 6-12 months greater
* 12 years and older
* Decreased nasal NO values at baseline
* Compliance and ability to perform maneuvers and responsibilities

Exclusion Criteria:

* Oral or systemic steroids for 60 days prior
* Inhaled, nasal, nebulized steroids w/i 4 weeks
* Hospitalization or life threatening asthma
* Use of nasal or oral antihistamines w/i 4 weeks
* Upper or lower airways infection
* Direct cigarette smoke exposure
Morphine-Sparing Efficacy Of Parecoxib In Pain Treatment After Radical Prostatectomy

The primary objective of this study is to demonstrate the opioid-sparing efficacy of parecoxib 40 mg intravenously given as a loading dose followed by 20 mg intravenously in the 24 hours after the end of surgery.

The study was terminated due to lack of recruitment due to competing alternative operation methods on 13September 2010. The decision to terminate the trial was not based on any safety concerns.

Eligibility Criteria:
Inclusion Criteria:

* The patient's ASA physical status is 1 or 2 and he has a low risk (i.e.,\<10%) of developing an acute coronary event within the next 10 years according to the PROCAM risk assessment calculator.
* The patient is scheduled to undergo routine radical prostatectomy performed under a standardized regimen of general anesthesia, and is expected to experience moderate to severe postsurgical pain in the absence of postoperative analgesia.

Exclusion Criteria:

* The patient has a history of uncontrolled chronic disease or a concurrent clinically significant illness or medical condition such as a diagnosed chronic pain condition, which, in the Investigator's opinion, would contraindicate study participation or confound interpretation of the results
* The patient has a history or current presence of congestive heart failure (NYHA II-IV), established ischaemic heart disease, peripheral arterial disease and / or cerebrovascular disease.
CLBS119 for Repair of COVID-19 Induced Pulmonary Damage

This clinical trial will explore the safety and potential efficacy of CLBS119 for the repair of COVID-19 induced pulmonary damage in adults.

This open-label clinical trial will explore the safety and potential efficacy of peripheral blood derived autologous CD34+ cells for the repair of COVID-19 induced pulmonary damage in adults. Eligible subjects will receive a single administration of CLBS119.

Eligibility Criteria:
Inclusion Criteria:

* Initial diagnosis with COVID-19 based on nasopharyngeal, oropharyngeal, or tracheobronchial aspirate SARS CoV-2 RT-PCR test
* Receiving or received ventilatory support for COVID-19 pneumonia/ARDS
* Evidence for ongoing pulmonary involvement based on P/F ratio \<300
* Able to provide informed consent

Exclusion Criteria:

* Immunocompromised or current use of immunosuppressive agents other than corticosteroids
* History of autoimmune disease
* Evidence of multiorgan failure
* Subject is pregnant or lactating at the time of signing the consent
* Participation in any other clinical trial of an experimental treatment for COVID-19
* History of sickle cell disease