cyrilzakka/clinical-trials huggingface dataset:
Comparison of Different Doses of Oestrogen Therapy for Preventing Intrauterine Adhesion

This single-center,prospective,randomized,controlled trial is conducted to evaluate the efficacy of different doses of estrogen artificial periodic therapy after hysteroscopic adhesiolysis in patients with moderate-severe adhesion.


Eligibility Criteria:
Inclusion Criteria:

1. Moderate and severe IUA according to the AFS IU adhesion scoring system (AFS 1988 version) (19) showed in Table1 (AFS score≥5);
2. Scheduled for hysteroscopic adhesiolysis;
3. Agreed to have two follow-up hysteroscopy; and
4. Written, informed consent obtained.

Exclusion Criteria:

1. Received estrogen therapy within 3 months of enrollment;
2. Suffering from leiomyoma, polyps, cancer, or polycystic ovarian syndrome (PCOS);
3. History of genital tuberculosis; and
4. Contraindication for estrogen therapy.
Osseodensifiction Versus Piezoelectric Internal Sinus Elevation Technique in Delayed Implant Placement

The present study is a parallel single-blinded randomized controlled clinical trial.

The study will be conducted after being reviewed and approved by the Faculty of Dentistry, AinShams University Research Ethics Committee (FDASU-REC).

The study population will be randomly allocated into two groups of the same size:

Group 1: Osseodensifiction sinus lift will be performed using sticky bone as a graft material.

Group 2: Piezoelectric Internal Sinus Elevation (PISE) will be performed using sticky bone as a graft material.

The aim of the present study is to evaluate the effectiveness and clinical results of osseodensification in comparison to Piezoelectric Internal Sinus Elevation (PISE) Technique in Delayed Implant Placement.


Eligibility Criteria:
Inclusion Criteria:

1. Patient partially edentulous with maxillary posterior edentulous ridge after extraction of more than 4 months.
2. Both sexes will be selected males and females.
3. Adult patients aged between 18 and 40 years of age.
4. Good general health (American Society of Anesthesiology Physical Status Ⅰ-Ⅱ).
5. Initial residual alveolar ridge height ranging between 4 to 6 mm according to preoperative CBCT.
6. No previous surgery or radiation treatment on the maxillary sinus.

Exclusion Criteria:

* 1. Smokers. 2. Pregnant or lactating females. 3. Psychiatric disorders. 4. Uncontrolled systemic disease. 5. Hematologic diseases and coagulation disorders. 6. Chemotherapy or radiotherapy of the head and neck area, and immunocompromised status.

  7. Medical conditions affecting bone metabolism and ongoing treatment with bisphosphonates drugs or systemic steroids.

  8. Presence of acute or chronic sinus pathoses or sinus membrane perforation.
Study to Assess Steady-State Trough Concentrations, Safety, and Immunogenicity of Abatacept After Subcutaneous (SC) Administration to Subjects With Rheumatoid Arthritis (RA)

The purpose of this study is to study serum levels of Abatacept after subcutaneous dosing in subjects with RA.


Eligibility Criteria:
Inclusion Criteria:

* Meet ARA criteria for diagnosis of RA with active disease.
* RA diagnosis for at least 1 year.
* \> = 6 swollen joints.
* \> = 8 tender joints.
* Taking methotrexate (MTX) or MTX plus not more than 1 added oral DMARD for \> = 3 months and stable for 28 days prior to dosing.

Exclusion Criteria:

* Serious acute or bacterial infection in last 3 months.
* Chronic or recurrent bacterial infections.
* History of TB within previous 3 years or old TB not adequately treated.
* Specific lab test abnormalities
* History of cancer within 5 years.
* Exposure to CTLA4Ig (Cytotoxic T-lymphocyte (T-cell)-associated antigen 4Ig), belatacept, rituximab, efalizumab, alefacept, or other investigational drug or biologic.
* Treatment with hydroxychloroquine, azathioprine, leflunomide, immunoadsorption columns, mycophenolate mofetil, cyclosporine, D-Penicillamine or calcineurin inhibitors.
* Exposure to live vaccines.
A Long Term Study of STN1012600 in Subjects With Open Angle Glaucoma or Ocular Hypertension

To evaluate safety and the ocular hypotensive effect of STN1012600 ophthalmic solution 0.002% alone or in combination with Timolol ophthalmic solution 0.5% for 52 weeks in subjects with open angle glaucoma or ocular hypertension.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older.
* Diagnosis of OAG or OHT in both eyes, or one eye with OAG and the other with OHT.
* Corrected Visual Acuity of +0.60 logMAR (Decimal visual acuity 0.3) or better in each eye.

Exclusion Criteria:

* Presence of any active severe external ocular disease, inflammation, or infection of the eye and/or eyelids in either eye.
* History of severe ocular trauma in either eye.
* Any condition that prevents clear visualization of the fundus in either eye.
* Known allergy, hypersensitivity or contraindications to any components of the study medications or other study related procedures/medications.
* History of ocular surgery specifically intended to lower IOP in either eye.
* History of keratorefractive surgery in either eye.
* Females who are pregnant, nursing, or planning a pregnancy.
* Subjects with known or suspected drug or alcohol abuse.
* Participation in other investigational drugs or device clinical trials within 30 days prior to Screening.
* Any decision by the Investigator to terminate a subject in screening or declare any subject ineligible for any sound medical reason.
Steroid Metabolism in Obese and Non-Obese Pediatric Patients Hospitalized for Status Asthmaticus

Single center, open-label, non-randomized study to assess the pharmacokinetic profile of methylprednisolone in healthy children 2-20 years of age admitted for asthma exacerbation.

This is a prospective study aiming to characterize the pharmacokinetics of methylprednisolone in obese and non-obese children hospitalized for asthma, and to build a metabolomic profile for each cohort. The primary hypothesis is that the obese cohort will have increased methylprednisolone clearance compared to the non-obese cohort. The secondary hypothesis is that the obese cohort will have decreased amounts of 11-β-hydroxysteroid dehydrogenase in the serum which will correlate to abnormalities in steroid clearance. The tertiary hypothesis is that the obese cohort will have increased levels of branched chain amino acids and inflammatory markers which will correlate to disease severity.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 2 years and 20 years inclusive
2. Written informed consent provided by a parent or legal guardian
3. Admitted to Duke Children's Hospital for primary reason of asthma exacerbation (and treated with methylprednisolone)
4. BMI-percentile greater than 95th for obese subjects and BMI less than 95th percentile for non-obese subjects

Exclusion Criteria:

1. Patients with suspected liver failure, renal failure, sepsis, or cardiopulmonary instability deemed by the PI.
2. Receiving any extracorporeal life support including extracorporeal membrane oxygenation, ventricular assist devices, and renal replacement therapy at enrollment
3. Any condition or circumstance that, in the opinion of the investigator, would compromise the safety of the participant or the quality of the data.
S9719 Gene Damage Following Chemotherapy in Women With Stage II or Stage III Breast Cancer

RATIONALE: Drugs used in chemotherapy for breast cancer may damage the genes of cells. This may lead to the development of secondary cancers.

PURPOSE: Pilot study to evaluate the degree of gene damage following chemotherapy in women with stage II or stage III breast cancer involving four to nine axillary lymph nodes.

OBJECTIVES: I. Estimate the incidence of early genetic damage, defined by the presence of clonal hematopoiesis using the human androgen receptor assay (HUMARA), in pretreatment blood and bone marrow, apheresis, and two sequential post-treatment specimens from women with stage II/III breast cancer enrolled in SWOG-S9623. II. Detect genetic damage following dose-intensive adjuvant regimens for breast cancer by screening for the presence of defective DNA mismatch repair mechanisms and loss of heterozygosity using microsatellite instability assays. III. Estimate the incidence of myeloid lymphoid leukemia gene fusion transcripts in cases where either the HUMARA or microsatellite repeat assays are positive for clonal hematopoiesis. IV. Determine the frequency of RAS gene mutations (H-, K-, and N-RAS) following dose-intensive adjuvant regimens for breast cancer.

OUTLINE: Prior to beginning treatment on SWOG-9623, blood samples and bone marrow aspirates (when available) are collected from each patient. Patients randomized to autologous peripheral stem cell transplant have specimens collected again at 3 months (apheresis aliquot and blood). At 3 and 12 months after completing chemotherapy, blood samples are collected from all patients. Samples are collected again from any patient presenting with a second malignancy in the future. DNA is collected from blood or bone marrow samples. Clonality at the HUMARA locus is examined. Microsatellite instability is assessed at multiple chromosomal loci: 7q31, 5q31, 17p12, 8p22, 11q23, and the BAT loci. If the HUMARA or microsatellite repeat assays are positive for clonal hematopoiesis, then specimens are examined for myeloid lymphoid leukemia fusion transcripts commonly reported in acute myeloid leukemia with 11q23 abnormalities. Specimens are also examined for RAS mutations (H-, K-, N-RAS). Patients do not receive the results of the genetic testing and the results do not influence the type or duration of treatment.

PROJECTED ACCRUAL: This study will accrue 100 patients for each arm of SWOG-9623, for a total of 200 patients.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Must be enrolled in SWOG-9623 at time of registration to this study, but must not have started treatment Hormone receptor status: Not specified

PATIENT CHARACTERISTICS: Age: Adult Sex: Female Menopausal status: Not specified Performance status: See Disease Characteristics Life expectancy: SWOG 0 or 1 Hematopoietic: See Disease Characteristics Hepatic: See Disease Characteristics Renal: See Disease Characteristics

PRIOR CONCURRENT THERAPY: See Disease Characteristics
Comparison Effects of Two Regional Anesthetic Technique on Pain During High Risk Hip Fracture Surgery

In this study, our is to compare effect of lumbosacral plexus and sacral plexus + suprainguinal fascia iliaca plane block on perioperative pain via analgesia nociceptive index monitor on high-risk patients undergoing hip fracture surgery.

The most preferred types of anesthesia in hip surgery are general anesthesia or neuraxial blocks. Both types have advantages as well as disadvantages. They may cause hemodynamic instability in geriatric and comorbid patient groups.

Peripheral nerve blocks have been associated with fewer complications both in the treatment of postoperative pain and in fragile, high-risk patients, making them an alternative to other anesthesia types.

It is important for patients to accurately measure their perioperative analgesic needs. There are many subjective methods for assessing pain. In the evaluation of analgesia level with Analgesia Nociception Index (ANI) monitorization, it is advantageous to evaluate the objective findings measuring parasympathetic system activity.

ANI is a monitor that can be measured continuously and non-invasively. It measures parasympathetic tone - based on electrocardiography - by analyzing minimal changes in heart rate that occur under anesthesia, in the early stages of awakening, and in each respiratory cycle of awake patients. At the end of the measurement, a value between 0-100 is obtained.

Parasympathetic modulation (stress level, e.g., pain) is obtained with a minimum value of 0 and a maximum of 100. ANI values measured in the early period of recovery correlate with pain scores. When compared with hemodynamic parameters, it has been reported that the ANI response is more sensitive to nociceptive stimuli occurring in the intraoperative period.

In the high-risk patient group who will undergo hip surgery in the Faculty of Medicine of Erciyes University, the pain sensation in patients will be evaluated using ANI in the perioperative period, after the peripheral nerve blocks have been applied to different anatomical areas that are routinely used.

The aim of this study is to objectively reveal the perioperative pain after peripheral block applications in the patient group with serious additional morbidities by using the ANI device. It is expected that this study will enable more effective analgesia control in patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients over the age of 18 who will undergo hip surgery
* ASA group 3-4 patients
* Patients without allergies
* Patients without psychiatric disorders
* Patients without opioid dependence
* Patients without severe liver and kidney failure
* Patients without arrhythmia and beta-blocker use
* Patients without contraindications for peripheral blocks

Exclusion Criteria:

* Patients who do not accept peripheral nerve block
* Patients with failed peripheral nerve block
* Patients scheduled for bilateral hip fracture surgery
* Patients who have been operated on for hip fractures before
* Patients with arrhythmia and beta-blocker use
* Patients with contraindications for peripheral blocks
* Chronic opioid consumption
Development of a Validated Chart for Intermediate Vision Assessment

Development of a validated computer-based instrument (software program) for the assessment of intermediate visual acuity.

Development of a validated computer-based instrument (software program) for the assessment of intermediate visual acuity (IVA). It is known that no validated method for the evaluation of IVA exists.

Primary objective of the study is to validate a specific computer-based chart (optotype) that will enable: a) comparative studies among different groups of presbyopic patients with refractive errors (ie. myopia, hyperopia, and/or astigmatism), and, b) assessment of the efficacy of surgical refractive procedures (ie. LASIK) on presbyopic patients.

Intermediate Visual acuity chart is similar to the prevalent Jaeger chart. It consists of short blocks of text in various type sizes.The computer screen is set at a specific reading distance (1 meter) and the patient is asked to read the passage with the smallest type he/she can see. According to the smallest text he/she can read, IVA is classified from IVA1 (which is considered the equivalent of 20/20 distance visual acuity) to IVA5

Validation of the computer-based IVA chart will be done by correlating the results of the IVA chart to the corresponding ones from the validated 20/20 distant and Jaeger near visual acuity charts, in a random sample of study participants with different refractive errors and different near and distant visual acuities.

Eligibility Criteria:
Inclusion Criteria:

* native Greek participants or foreigners with perfect knowledge (verbal and written) of Greek language

Exclusion Criteria:

* glaucoma or suspicion for glaucoma,
* corneal disease or suspicion for corneal disease
* fundus disease or suspicion for fundus disease
* pregnancy or nursing,
* underlying autoimmune disease
* mental or neurologic disease
Psoriatic Arthritis Dose Ranging Study for BMS-945429 in Subjects Who Are Not Responding to NSAIDs or Non-biologic Disease Modifying Anti-rheumatic Drugs (DMARDs) Therapy

The purpose of this study is to characterize the safety, efficacy and dose response of BMS-945429 in subjects with active Psoriatic Arthritis and an inadequate response to Nonsteroidal anti-inflammatory drugs (NSAIDs) and non-biologic Disease modifying anti-rheumatic drugs (DMARDs).


Eligibility Criteria:
Inclusion Criteria:

* Must be on a stable background Methotrexate (MTX) therapy prior to Day1/Randomization. Subjects must have taken MTX for at least 3 months at a dose ≥ 15 mg/week to a maximum weekly dose of ≤ 25 mg/week, and be at a stable dose for 4 weeks prior to randomization (Day 1). Methotrexate dose ≥ 15 mg/week that was not efficacious and that was decreased due to toxicity as low as 10 mg/week is allowed
* Inadequate response to NSAID and/or non-biologic DMARD
* Minimum of 3 swollen and 3 tender joints
* Active psoriatic skin lesions over minimum 3% body surface area
* high sensitivity C-reactive protein (hsCRP) ≥ 0.3 mg/dL

Exclusion Criteria:

* Previously received or currently receiving concomitant biologic therapy
App-technology to Improve the Level of Physical Activity After Bariatric Surgery

The aim of this study is to investigate the effect of using new app-based technology to increase the level of physical activity, compared to conventional postoperative information given to patients undergoing bariatric surgery. The hypothesis is that the intervention, i.e. using the new technology, will have a greater positive effect on levels of physical activity and outcomes of weight loss than conventional postoperative information.


Eligibility Criteria:
Inclusion Criteria:

* Accepted to bariatric surgery due to national guidelines, BMI\>35 kg/m2
* 18 years of age or older
* Informed consent
* Ability to read and understand Swedish
* Own and use a smartphone

Exclusion Criteria:

* Disability preventing daily walking
CTSI-iPad for Vented Patient Communication

This study will enroll 75 mechanically vented adults in the ICU to compare self-reported ease of communication, patient satisfaction, and patient anxiety and frustration levels between a group using a communication application on an iPad and a group using standard methods of communication while mechanically vented.

The Investigators will randomize patients to either an iPad application available for communication or usual care. An existing iPad communication application (Proloquo2Go) that allows picture or text to voice communication was tailored to needs of adult mechanically ventilated (MV) patient. In the tailored application, common messages for an adult MV population are depicted on picture tiles organized into folders. When patients touch a picture tile either additional message options appear or a phrase or word is spoken by the device. Access to a pop-up keyboard on each screen allows patients to easily type unique text to voice messages.

Intervention: Patients will be randomized to either an iPad with the tailored communication application or usual care. Patients randomized to the iPad group will be given a brief introduction to the communication application and then will be asked to communicate four messages to verify understanding. Patients who are unable to successfully use the iPad with the initial introduction will remain in the study. Research staff will continue to assist the patient daily and a speech language pathologist will be consulted to facilitate the patients ability to use the device. The iPad will remain at the bedside to be used for communication as desired for the remainder of the time the patient is on the ventilator. A manual providing instruction for the iPad and application operation will be at the bedside of all patients randomized to the intervention group. Research staff will visit patients daily to assist with any problems encountered and will also be available by phone to assist as needed. Although patients will be encouraged to use the iPad for communication, use of other strategies or tools will not be restricted.

Eligibility Criteria:
Inclusion Criteria:

1. Sufficient motor and visual function to allow use of touch screen
2. Mechanically ventilated
3. Awake and able to participate in informed consent discussion

Exclusion Criteria:

1. Non-English Speaking
2. Receiving ventilator support prior to admission.
3. Delirium present in the last 24 hours
4. Tracheostomy
5. Structural Neurological Injury (such as stroke or traumatic brain injury)
6. Coma
7. Deep Sedation (Richmond Agitation Scale \> -2)
Pediatric Refraction With SVOne Autorefractor

The study is used to verify the accuracy and repeatability of Smart Vision Labs Refractor in a pediatric population (between 5 and 16 years of age).


Eligibility Criteria:
Inclusion Criteria:

1. healthy children
2. ages 5-16 year
3. male and female

Exclusion Criteria:

1. presence of ocular disease
2. refractive surgery
3. amblyopia
Zanubrutinib-rituximab(ZR) in Patients With Newly Diagnosed Untreated Mantle Cell Lymphoma

The proposed study is a prospective, single-center, single-arm and open-ended phase II study in patients over the age of 18 with previously untreated mantle cell lymphoma(MCL). The primary objective of this study is to explore the safety and efficacy of a new chemo-free treatment pattern zanubrutinib-rituximab(ZR) in newly diagnosed MCL.

The study will start with an initial 28-days of induction immunotherapy with ZR and 4 cycles of consolidation immunotherapy with ZR，following imaging examinations to evaluate response rates. Patients who are evaluated as SD and PD will be withdrawn from the trial,while those who achieve PR and CR will be further stratified according to their age and physical status. The older or frail patients who are ineligible for ASCT will take zanubrutinib orally until intolerable toxicity or disease progression. Patients who are young and fit for transplantation will receive ASCT consolidation. After ASCT, patients with CR will end therapy and enter the follow-up stage, while patients with PR will continue to take zanubrutinib orally until intolerable toxicity or disease progression.

Eligibility Criteria:
Inclusion Criteria:

1. Histopathologically or Cytologically confirmed Mantle Cell Lymphoma(excluding indolent Mantle Cell Lymphoma) by the 2008 World Health Organization (WHO) Classification of diseases;
2. Initial untreated patients;
3. Age ≥ 18 years;
4. ECOG score 0-2;
5. Women must not be pregnant or breastfeeding and agree to avoid pregnancy prior to study entry, for the duration of study participation, and for 12 months thereafter. Male patients must agree that their spouses will not become pregnant during the study period and for 12 months thereafter;
6. Patients must have measurable disease (i.e., ≥ 1.0 cm in lymph nodes diameter; or skin lesions assessed by physical examination);
7. Written informed consent obtained from the subject.

Exclusion Criteria:

1. Indolent Mantle Cell Lymphoma;
2. Patients with severe liver and kidney dysfunction (alanine aminotransferase, bilirubin, creatinine \> 3 times the upper limit of normal)
3. Uncontrolled active infection, with the exception of tumor-related B symptom fever;
4. Patients with organic heart disease with clinical symptoms or cardiac dysfunction (NYHA grade ≥2);
5. Co-existence of other tumors;
6. Any other psychological conditions that prevent patients from participating in the study or signing the informed consent form.