cyrilzakka/clinical-trials huggingface dataset:
Sperm Production in Kleinfelter Syndrome Patients After Mesenchymal Stem Cell Injection

Klinefelter syndrome KS is caused by an additional X chromosome in males (47,XXY). Clinical findings are nonspecific during childhood; thus, the diagnosis commonly is made during adolescence or adulthood in males who have small testes with hypergonadotropic hypogonadism and gynecomastia. Virtually all men with Klinefelter syndrome are infertile.

Approximately one in 1,000 boys is born with an additional X chromosome-47,XXY, the karyotype that causes Klinefelter syndrome. This karyotype is detected at or before birth in 10 percent of affected boys, and it is found during adulthood in 25 percent of affected men. Almost all men with a 47,XXY karyotype will be infertile; Klinefelter syndrome accounts for 3 percent of male infertility.

Klinefelter syndrome is common in infertile men with oligospermia or azoospermia (5 to 10 percent).

Infertility in men with Klinefelter syndrome is caused by a precipitous drop in sperm count. If sperm are present, cryopreservation is useful for future family planning with intracytoplasmic sperm injection, and if not, testicular sperm extraction may be pursued. Although there have been multiple reports of successful fertilization by men with Klinefelter syndrome.

Mesenchymal stem cell injection in testicular tubules and intra testicular artery using surgical microscope.

The period for follow up last from three months to twelve months including semen analysis to detect sperm and hormonal profile .

The problem started with this kind of patinets when underwent multiple TESE without sperm.

The investigators try to inject KS patients with mesenchymal stem cells to stimulate testicular tissue for production of sperms.

before injection the investigators measure:( FSH, LH, Testosterone, Prolactin, Inhibin B, Karyotyping, Azoospermic Factor, Testicular size by ultrasound).

Three to twelf months after stem cell injection the investigators reevaluate patients by the same measure to demoenstarte any changes.

Eligibility Criteria:
Inclusion Criteria:

* Kleinfelter syndrome
* Azoospermia
* Negative TESE

Exclusion Criteria:

* Absent Testes
The CEASE Study: Computer Based Educational Module for the Reduction of Arthralgia Syndrome Associated With Endocrine Therapy for Breast Cancer

Patients have been asked to participate in the CEASE study because their treating oncologist has recommended that they start an aromatase inhibitor medication. These medications are associated with joint complaints. The purpose of this study is to see whether a computer-based educational module is a feasible intervention to help address these symptoms. If the patients agree to participate, a research coordinator will test their grip strength and give them a computer log-on code. They will be shown how to log-on to complete the educational module and a few simple questionnaires. Patients have the option to do this from home if they wish. In 3 months time, the investigators will ask patients to return to the clinic and have another grip strength evaluation and complete some additional questionnaires. The computer module and the follow up visit will each take about 30 minutes of time.


Eligibility Criteria:
Inclusion Criteria:

* Post-menopausal stage I-III breast cancer patients
* Starting or about to start aromatase inhibitor
* English speaking with ability to read, write and use a computer to watch and listen to an educational module.
* Able to give informed consent

Exclusion Criteria:

* Aromatase inhibitor (AI) use for more than 6 months
* Metastatic breast cancer
* Non-English speaking, or unable to read, write or use a computer to watch and listen to an educational module.
* Unable to give informed consent
Effectiveness of Laser Photobiomodulation Therapy in Reducing Child Pain During Local Anesthesia Injection

This study aimed to evaluate the impact of laser photobiomodulation therapy used as pre-anesthetic technique to reduce child pain during local anesthesia administration


Eligibility Criteria:
Inclusion Criteria:

* Completion of the written informed consent form by parents/guardian.
* Children with dental behavior score of 3 or 4 according to the Frankel behavior rating scale.
* Patients whom their maxillary primary molars are indicated for pulpotomy and SSC restoration.
* Lack of history of allergy to the materials used for anesthesia and sulfite
* Children free of any systemic disease or special health care needs (ASA 1)

Exclusion Criteria:

* Children who receive any analgesic drugs at least 24 hours before treatment.
* Any inflammation or lesion in the injection site
* Patients who have previous bad experience of dentistry were excluded to eliminate the possible impact of the child's previous painful or stressful experiences
* Child coming for emergency treatment of pain
A Study of Factors That Affect Long-Term Kidney Transplant Function

The causes of deterioration of transplanted kidney function are poorly understood. The purpose of this study is to determine the disease processes that cause transplanted kidney dysfunction and loss in patients who received a kidney either recently or over a year prior to entering this study. This study will also identify specific characteristics in kidney transplant recipients that predict whether a kidney transplant will be successful.

Over time, chronic kidney graft dysfunction progressively threatens the long-term survival of a kidney graft. The disease processes behind graft dysfunction are unclear. However, chronic kidney graft dysfunction is likely to be caused by certain definable factors. Such factors may include collagens III and IV, transforming growth factor (TGF)-beta, T and B cell surface markers, cell cycle proteins, fibronectin, and laminin. Determining what disease processes and which specific factors are most responsible for kidney graft dysfunction may help in designing future interventional trials for kidney transplant patients. The purpose of this study is to determine whether clinical, laboratory, and histologic studies at the time of initial graft dysfunction will clarify the processes and factors that lead to deterioration and loss of a kidney graft. This is an observational study that will enroll participants who have recently received kidney transplants (prospective cohort) and participants who have had kidney transplants for a longer period of time and are now experiencing kidney graft dysfunction (retrospective cohort).

The duration of this trial may differ between participants, depending on when deterioration of kidney graft function occurs. Participants will be followed until graft loss or death. There are no exclusive study visits associated with this study. Study data are gathered from routine laboratory follow-up tests completed at the participant's local medical center and from information obtained at the time of kidney biopsy. Participants may need to undergo a kidney biopsy as clinically indicated. At the time of biopsy, participants will also undergo urine and blood collection.

Eligibility Criteria:
Inclusion Criteria for Prospective Cohort:

* Received a kidney transplant within 10 days prior to study entry, on or after 10-01-2005
* Recipient of kidney or simultaneous kidney/pancreas with no additional transplant at the time of the kidney transplant

Inclusion Criteria for Retrospective Cohort:

* Received a kidney transplant before 10-01-2005
* Recipient of kidney or simultaneous kidney/pancreas with no additional transplant at the time of the kidney transplant
* Undergoes a clinically indicated kidney biopsy due to new onset deterioration of function, defined as having an increase in serum creatinine
* The creatinine level on or before 01-01-2006 must be 2 mg/dl or less OR the patient must have developed new onset proteinuria, defined as having a protein/creatinine ratio of 0.4 or more
The Feasibility Study of the Li Brush for the Screening of Endometrial Cancer in the Postmenopausal Period

Investigators aim to collect endometrial sampling with Li Brush among target population who have risks for endometrial neoplasm, then Fractional curettage should performed with these participants, investigators intend to compare the pathological diagnosis results of cytology and fractional curettage to evaluate the sensitivity of Li Brush and investigators expect that the brush can be used for screening of endometrial cancer in the postmenopausal period in the clinic.

Investigators screen the suitable participants according to the inclusion and exclusion standards, and then collect their endometrial sampling with Li Brush. Pathologists will help to decide the cytology obtained by Li Brush and histology diagnosis of the endometrial sampling. Comparing the pathological diagnosis results of cytology and histology, investigators want to prove the feasibility of cytology diagnosis of endometrial cancer in the postmenopausal period, as the same time, investigators intend to evaluate the possible factors that affecting the precision of Li Brush for endometrial cancer in the postmenopausal period.

Eligibility Criteria:
Inclusion Criteria:

1. Postmenopausal abnormal uterine bleeding;
2. Ultrasound of the pelvic showed thickened endometrial ( usually more than 5mm) ;
3. Family history of endometrial cancers;
4. Other participants with risks for endometrial cancer (such as fat, Lynch Syndrome and so on)

Exclusion Criteria:

1. Cervical cancer;
2. Fever (body's temperature is higher than 37.5 degrees );
3. Vaginitis (excluding atrophic vaginitis);
4. Patients who cannot bear the operation;
5. Coagulation disorders;
6. Pregnancy and suspected pregnancy.
Bare Metal Stent Versus Drug Coated Balloon With Provisional Stenting in Non-ST-Elevation Myocardial Infarction

The aim of the present trial is to assess the efficacy of the standalone use of SeQuent(R) Please coated balloon compared to a bare metal stent (BMS) in patients with NSTEMI.

The aim of the present trial is to assess the efficacy of the standalone use of SeQuent(R) Please coated balloon compared to a bare metal stent (BMS) in patients with NSTEMI. Primary efficacy endpoint will be MACE (cardiac mortality, reinfarction, and target lesion revascularization) after 9 months.

Eligibility Criteria:
Inclusion Criteria:

* NSTEMI with
* Ischemic symptoms (angina pectoris) \> 30 minutes
* Last symptoms within 72 hours before randomization
* Positive cardiac troponin T, I, or hs-Troponin above 99th percentile
* age \> 18 years
* Identifiable culprit lesion without angiographic evidence of large thrombus with intended early PCI (treatment of up to two lesions allowed)

Exclusion Criteria:

* Cardiogenic shock
* ST-elevation myocardial infarction
* No identifiable culprit lesion, Indication for acute bypass surgery
* Comorbidity with limited life expectancy \< 9-12 months
* Contraindication for treatment with heparin, ASA and thienopyridines
Celecoxib Treatment for Lung Cancer

This proposal evaluates cyclooxygenase 2 (COX-2) inhibition as a means to decrease T regulatory cell activities and thus augment immune responses against lung cancer. The broad goal focuses on understanding how COX-2 expression regulates the malignant phenotype in non small cell lung cancer in an effort to foster an informed approach for the use of COX-2 inhibitors in prevention and therapy for lung cancer.


Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed and surgically resectable non small cell lung cancer and subjects must be ineligible for or refuse, neoadjuvant therapy

Exclusion Criteria:

Hypersensitivity to celecoxib or NSAIDs, previous history of GI bleeding or ulceration, chronic or concurrent use of steroids and renal insufficiency
Safety and Efficacy of MAK683 in Adult Patients With Advanced Malignancies

The purpose of this Phase I/II study is to establish the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) and to evaluate the safety, antitumor activity and pharmacokinetic (PK) profile of MAK683 in patients with advanced malignancies such as Diffuse Large B cell Lymphoma (DLBCL), nasopharyngeal carcinoma (NPC) or other advanced solid tumors for whom no further effective standard treatment is available.

The purpose phase I of this trial is to characterize safety and tolerability and determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of MAK683.

The purpose of the phase II of this trial is to evaluate the anti-tumor activity of MAK683. Phase II part will not be opened.

Eligibility Criteria:
Inclusion Criteria:

1. Eastern Cooperative Oncology Group (ECOG): 0 to 2
2. Relapsed or refractory diffuse large B cell lymphoma with measurable disease as determined by Non-Hodgkin's Lymphoma Cheson response criteria (2014)
3. Advanced or recurrent/metastatic solid tumor, including nasopharyngeal carcinoma, castration-resistant prostate cancer, gastric cancer, ovarian clear cell carcinoma and sarcoma, with measurable disease as determined by RECIST 1.1.

Exclusion Criteria:

1. Other malignant diseases than the ones being treated in this study
2. Severe and/or uncontrolled medical conditions that in the investigator's opinion could affect the safety of individual or impair the assessment of study result.
3. B-cell lymphoma patients who have received prior allogeneic stem cell transplant
4. Patient have received anti-cancer therapies within defined time frames prior to the first dose of study treatment
5. Symptomatic central nervous system (CNS) involvement which are neurologically unstable or requiring increasing doses of steroids to control.
6. Patient having out of range laboratory values defined as:

1) Insufficient bone marrow function at screening:

* Platelets ≤ 50,000/mm3
* Hemoglobin (Hgb) ≤ 80 g/L
* Absolute neutrophil count (ANC) ≤ 1000/mm3 2) Insufficient hepatic and renal function at screening:
* ALP, ALT, and AST \> 3 x ULN (\>5 x ULN if subject has liver metastases)
* Total bilirubin \>1.5 x ULN
* Serum creatinine \> 1.5 x ULN and/or creatinine clearance ≤ 50 mL/min
Application of Hyaluronic Acid in Diabetes

sub gingival application of hyaluronic acid create great clinical improvement of periodontal pocket treatment.

To clinically and radiographically evaluate the adjunctive effect of the local application of a 0.8% hyaluronan gel in addition to scaling and root planing in treatment of controlled diabetic patients with stage II periodontitis.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years.
* Patient with controlled diabetic type 2 (HgA1C \<7) (Mori et al., 2021).
* Periodontitis stage II.
* Periodontitis grade B.
* Pocket depth \> 4 mm.
* Smoking ≤ 10 cigarettes/day.
* Cooperative patients able and accept to come for follow up appointments

Exclusion Criteria:

* • The use of antibiotics or anti-inflammatory drugs 1 month prior to the procedure and till the end of 6 months of follow-up.

  * Having surgical therapy or undergoing orthodontic treatment.
  * Ongoing drug therapy that might have an impact on the clinical signs and symptoms of periodontitis.
  * Pregnant and lactation females.
  * Smoking ˃ 10 cigarettes/day.
  * Patients with poor oral hygiene.
  * Any known allergies
Comparing Glycaemic Benefits of Active Versus Passive Lifestyle Intervention in Kidney Allograft Recipients

Post-transplantation diabetes mellitus (PTDM) is a common medical complication after kidney transplantation, related to both transplant-specific and generic risk factors, and is associated with major complications after transplantation. The current PTDM Consensus Report recommends lifestyle modification (e.g. weight loss, dietary modification, structured exercise program) as the first line therapy of choice. No recommendation is given with regards to how such guidance should be delivered. In addition no clinical evidence exists to suggest lifestyle modification provides any sustained glycaemic benefits for kidney allograft recipients.

While in the general population the benefits of lifestyle modification have been well documented with regards to attenuation of both pre-diabetic and diabetic states in the context of randomised controlled trials, no similar level of evidence exists post kidney transplantation.

This prospective randomised controlled trial is designed to compare active versus passive lifestyle intervention post kidney transplantation, to determine changes in cardio-metabolic risk profile over the course of the intervention.


Eligibility Criteria:
Inclusion Criteria:

* Age\>18, kidney allograft only, functioning allograft (not on dialysis), 3-24 months post-transplant

Exclusion Criteria:

* Organ transplant recipient, pre-existing diabetes, pregnancy
Media Literacy for High School Tobacco Prevention

This research project will explore the feasibility and acceptability of a web-based media literacy tobacco prevention program. The project will be conducted with 9th or 10th graders in two high schools in Pittsburgh, Pennsylvania.

Specific Aim 1: To assess students' preferences for delivery of the web-based media literacy tobacco prevention program. Investigators will conduct focus groups with students. Students will be shown clips from the program and asked to provide feedback about the preferred frequency and setting for the program.

Specific Aim 2: Investigators will conduct a pilot trial of the intervention via a cluster randomized controlled trial. The control group will receive their usual health education curriculum. The intervention group will receive their usual health education curriculum with the addition of the intervention. All students will be asked to complete a pre-test, a post-test, and two follow-up surveys (approximately 4 and 12 months post-intervention). Feasibility endpoints will include overall program completion, recruitment/attendance rates, and retention rates. Acceptability outcomes will assess student perceptions toward the intervention. A sub-aim will be to conduct focus groups and interviews with students, teachers, and administrators to assess implementation barriers and facilitators.

Eligibility Criteria:
Inclusion Criteria:

* 9th or 10th grade student
* enrolled at participating Pittsburgh-area school

Exclusion Criteria:

* Inability to read the surveys
Dual Artery Compression vs. Radial Artery-Only Hemostasis: Impact on Radial Artery Occlusion (EASY-RAO)

This study aims to demonstrate the superiority in clinical performances of a dual artery compression device (Terry-2 band) compared to a standard radial artery-only hemostasis device (HemoSTOP).


Eligibility Criteria:
Inclusion Criteria:

* any patients referred for diagnostic angiography and possible percutaneous coronary intervention (PCI)

Exclusion Criteria:

* Patient unable to understand study design or objectives
* Unable to sign informed consent
* Patient taking warfarin or other anticoagulant therapy
* Chronic RAO on both sides precluding TRA
* Previous ipsilateral transradial approach
* Inability to comply with the study follow-up
* Presence of plethysmographic waveform with radial and ulnar occlusive compression
* Pre-existing local complication (i.e. hematoma, pseudo-aneurysm, ...) precluding access-site evaluation.
Cognitive Behavioral Therapy on Adherence and Depression (CBT-AD) Among HIV/AIDS Patients

Depression is highly comorbid with HIV/ AIDS and is associated with worse poor adherence to antiretroviral therapy (ART), and potentially to long-term immune functioning. Cognitive behavioral therapy may solve these problem.

Depression is highly comorbid with HIV/ AIDS and is associated with worse poor adherence to antiretroviral therapy (ART), and potentially to long-term immune functioning. Poor adherence decreases the benefits of ART as well as chances of prolonged survival. An intervention that integrates CBT for depression with a cognitive behavioral approach to adherence counseling (cognitive behavioral therapy intervention for adherence and depression (CBT-AD)) has been found to be effective in improving adherence and reducing depression in PLWH.

Eligibility Criteria:
Inclusion Criteria:

* PLWHA who were 18 years old and above were included in the study

Exclusion Criteria:

* PLWHA who were previously took CBT and participants with acute physical or mental disturbances were excluded.
A Comparison of Bupivacaine and Ketorolac for Postoperative Analgesia After Iliac Crest Bone Harvesting

The efficacy of three postoperative pain management regimens will be compared in patients undergoing Lefort I osteotomy or alveolar cleft repair with Iliac crest bone grafts (ICBG) to determine the best way of managing postoperative pain.

Iliac crest bone grafts (ICBG) are used for many types of surgeries including alveolar cleft repair, Lefort I osteotomies, spinal fusion, and fracture management. ICBG donor sites are notoriously painful, and the pain is often more severe than that from the primary operative site.

Postoperative pain management after operations that involve harvesting ICBG usually includes opioids, which are most often delivered by a patient-controlled device. Additional analgesics may include acetaminophen, non-steroidal anti-inflammatory (NSAID) drugs, and local anesthetic agents, such as bupivacaine or ropivacaine. Local anesthetics may also be injected intermittently or continuously into the wound via an indwelling catheter inserted at the time of surgery. All but one of these studies have shown a significant reduction in pain scores and opioid consumption using local anesthetic through an indwelling catheter.

Only one study has investigated the effects of NSAIDs on postoperative ICBG pain. This study found that intravenous ketorolac did not reduce morphine consumption. However, there was a trend to lower morphine use with ketorolac, and pain and patient satisfaction scores were not measured.

Currently, we do not use local anesthetic infusions via an indwelling iliac crest catheter for patients at our institution undergoing Lefort I osteotomy or alveolar cleft repair with ICBG since we find the above pain management regimen to be effective, with most patients using low to moderate amounts of morphine. To our knowledge, no study to date has compared the efficacy of ketorolac to local anesthetic infusions for patients undergoing Lefort I osteotomy or alveolar cleft repair with ICBG.

Eligibility Criteria:
Inclusion Criteria:

* Alveolar bone graft patients age 10-13 years of age
* Lefort I osteotomy patients needing ICBG age 14 to 20 years
* able to operate a patient-controlled analgesia (PCA) device

Exclusion Criteria:

* Allergy, sensitivity or contraindication to any non-steroidal anti-inflammatory drugs
* Allergy, sensitivity or contraindication to morphine
* History of gastric ulcer or bleeding diathesis