cyrilzakka/clinical-trials huggingface dataset:
Evaluation of a Long Versus Short Clomid Protocol for Controlled Ovarian Stimulation

The goal of this clinical trial is to evaluate a long Clomid protocol as compared to a 5-day Clomid protocol for ovarian stimulation in patients with diminished ovarian reserve undergoing ovarian stimulation for in-vitro fertilization or egg freezing. The aim of the long Clomid protocol is to intensify stimulation of the ovaries and reduce both cost and injection burden for patients. Participants will be randomized to receive the long Clomid protocol vs. the typical protocol involving Clomid only for 5 days followed by growth hormone-releasing hormone (GnRH) antagonist. The primary outcome the investigators will evaluate will be the number of eggs retrieved.

Clomiphene citrate (Clomid) is often used for assisted reproductive technologies and may be used to augment ovarian stimulation with exogenous gonadotropins by stimulating pituitary follicle-stimulating hormone (FSH) release in addition. The mechanism of action of Clomid is antagonism at the estrogen receptor, and this stimulates FSH release from the pituitary. The typical Clomid-based protocol has involved clomid only given for the first five days of stimulation to allow for endometrial development later in the cycle for a fresh embryo transfer following the oocyte retrieval. This protocol involves the addition of a GnRH antagonist medication later in the cycle to prevent premature ovulation. Recent national trends in IVF, however, have moved towards frozen embryo transfers and use of preimplantation genetic testing, which obviates any concerns regarding the endometrium. Recent experience in our clinic has suggested that Clomid may also prevent premature ovulation by antagonizing the positive feedback that is responsible for the luteinizing hormone (LH) surge and ovulation. Given in this manner, Clomid can be given throughout the duration of an ovarian stimulation cycle, achieve higher FSH levels and degree of ovarian stimulation in patients with diminished ovarian reserve, and obviate the need for GnRH antagonist medication (another expensive subcutaneous injection). The objective of this study is to compare a "long Clomid protocol" (i.e. using Clomid throughout the entire duration of the IVF cycle) as compared to the typical 5-day clomid protocol. The investigators hypothesize that the long Clomid protocol will be non-inferior to the typical five-day course and obviate the need for GnRH antagonist by preventing premature ovulation. Patients with diminished ovarian reserve and anticipated poor response to ovarian stimulation will be randomized to the long Clomid protocol vs. a 5-day Clomid with GnRH antagonist protocol. The primary outcome will be oocyte yield. Secondary outcome will be premature ovulation, embryo development, and pregnancy outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Diminished ovarian reserve
* Prior poor response to ovarian stimulation

Exclusion Criteria:

* Normal ovarian reserve or good response
* Allergy or adverse reaction to clomid
* Minimal stimulation protocols
* History of prior premature ovulation
Cladribine in Combination With CAG in Patients With Refractory/Relapsed Acute Myeloid Leukemia

The vast majority of patients with AML will die of the disease, and no standard chemotherapy regimen were defined for patients with relapsed/refractory AML. Previous studies have confirmed the efficacy of cladribine in the treatment of AML, both de novo or relapse/refractory AML. Our previous experience has shown that Cladribine in combination of CAG (G-CSF priming, low dose cytarabine, and aclarubicin) are effective with tolerable toxicity profiling.Thus, this phase 2 clincial trial is going to evaluate the efficacy and safety of cladribine in combination with G-CSF, low-dose cytarabine and aclarubicin (C-CAG) in patients with refractory/relapsed acute myeloid leukemia.

AML is most common in the elderly patients, who can not tolerate the intensified treatments. The vast majority of patients with AML will die of the disease, and no standard chemotherapy regimen were defined for patients with relapsed/refractory AML. Previous studies have confirmed the efficacy of cladribine in the treatment of AML, both de novo or relapse/refractory AML. Our previous experience has shown that Cladribine in combination of CAG (G-CSF priming, low dose cytarabine, and aclarubicin) are effective with tolerable toxicity profiling.Thus, this phase 2 clincial trial is going to evaluate the efficacy and safety of cladribine in combination with G-CSF, low-dose cytarabine and aclarubicin (C-CAG) in patients with refractory/relapsed acute myeloid leukemia.

Eligibility Criteria:
Inclusion Criteria:

* Men and women;
* Clinical diagnosis of Relapsed/Refractory AML (non-APL);
* ECOG performance status (PS) score 0-3;
* AST and ALT \<=2.5 times the institutional ULN;
* Total bilirubin \<=2.0 times the institutional ULN
* Serum creatinine\<2.0 times the institutional ULN;
* Subjects should take effective contraceptive measures，and serum or urine pregnancy tests must be negative during the screening and study periods in women subjects;
* Patients should understand the disease and voluntarily receive the study regimen and follow-up.

Exclusion Criteria:

* Concurrent diagnosis of tumors other than AML, with exclusion of superficial bladder cancer, basal cell and squamous cell carcinoma, cervical intraepithelial neoplasms (CIN), prostatic intraepithelial neoplasms(PIN);
* Active viral or bacterial infection that would impair the ability of the subject to receive protocol therapy;
* Concurrent autoimmune hemolytic anemia or immune thrombocytopenia;
* Subjects suffered from AIDS，active hepatitis B or C virus infection; 垫·Dementia or altered mental status that would prohibit the understanding or rendering of informed consent;
* Be allergic to any component of C-CAG regimen;
* Subjects ever exposed to cladribine or CAG-based regimen.
Telehealth Intervention for Youth With T1DM

Hospitalization of youth with established diabetes is both costly and frequently preventable. Poor glycemic control is a risk factor for hospitalization and is also associated with adolescent age and lower socioeconomic status. This is a randomized, controlled trial for high-risk adolescent youth with T1DM and suboptimal glycemic control with an intervention arm and usual care control arm matched for frequency of contacts. There will be 110 subjects with T1DM and HbA1c\>8%, aged 13 to 17 years, recruited from the Diabetes Program at Boston Children's Hospital and followed for 6 months. The intervention will be implemented by a diabetes nurse educator and social worker, who will each have monthly contact with the adolescent and a parent/guardian through a telehealth (videoconference) visit. Care will be guided by a diabetes action plan. Telehealth interventions have been utilized successfully in both adults and youth with diabetes. They facilitate frequent contact with the care team allowing barriers to adherence to be addressed, education to be reinforced, care plans to be updated, and diabetes-specific family support to be provided.


Eligibility Criteria:
Inclusion Criteria:

* Age 13 to 17 years
* Type 1 diabetes for ≥1 year
* HbA1c\>8%
* Able to speak and read English (Child)
* Able to speak and read English (Parent)
* Parent agrees to participate
* Parent and child each have email addresses

Exclusion Criteria:

* Plan to transition diabetes care to a center other than Boston Children's Hospital
* No visit to Boston Children's Hospital Diabetes Program in year prior to recruitment
* Current participation in another diabetes-related study with an intervention
* Living with or related to another study participant
* Significant psychopathology or medical illness that would limit the subject's ability to provide assent and/or participate in the study procedures as determined by the PI.
* No internet access
Pilot Study of TransAeris® System in Surgical Patients at Risk of Prolonged Mechanical Ventilation

This study will be conducted as a pilot trial of the TransAeris system for the prevention and treatment of ventilator-induced diaphragm dysfunction (VIDD) in patients identified prior to surgery to be at greater risk of prolonged mechanical ventilation (PMV).

This pilot study is an open label observational study in adult open cardiac surgery patients. Eligible patients from whom informed consent is obtained and electrodes are successfully implanted are enrolled in the study. All subjects will be implanted with the TransLoc electrodes during their primary surgery. Following admission to the ICU, diaphragm EMG recording will begin and continue until TransAeris use begins or until discharge from the ICU. TransAeris stimulation therapy adjunctive to continued MV will begin 24 hours after leaving the operating room. TransAeris stimulator settings (stimulus intensity, stimulus frequency, and burst on/off) will be programmed to optimize diaphragm recruitment without compromising patient comfort.

When deemed ready by the physician, the subject will perform a spontaneous breathing trial (SBT). Diaphragm EMG will be recorded for the first 15 minutes of an SBT, when performed with study staff available, then TransAeris therapy will continue. If an SBT is not performed on a day or performed when study staff is not available, a diaphragm EMG will be recorded for 15 minutes and then TransAeris therapy will be resumed. If the subject fails the SBT or the physician determines the subject is inappropriate for extubation, TransAeris stimulation therapy will continue. Prior to leaving the ICU, diaphragm EMG will be recorded for 15 minutes and the TransLoc electrodes will be removed. Subjects that reach Day 30 after implantation will stop TransAeris therapy. Diaphragm EMG will be recorded for 15 minutes and the TransLoc electrodes will be removed prior to the end of Day 30.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is undergoing an open cardiac procedure by median sternotomy
2. Subject is at risk of prolonged mechanical ventilation ≥ 24H
3. Subject is at least 22 years of age
4. Informed consent has been obtained from the subject or designated representative

Exclusion Criteria:

1. Subject is on invasive mechanical ventilation prior to procedure
2. Subject has known or pre-existing phrenic nerve paralysis
3. Subject has progressive, non-reversible neuromuscular disease affecting the diaphragm
4. Subject is pregnant or lactating
5. Subject is actively participating in another clinical study which could affect outcomes in this study
Effectiveness of Bethanechol Chloride and Early Bladder Training for Prevention of Bladder Dysfunction After Radical Hysterectomy in Cervical Cancer Stage IB - IIA

Compare the effectiveness of bethanechol chloride and early bladder training for prevention of bladder dysfunction after radical hysterectomy in cervical cancer stage IB - IIA.

Cervical cancer is the third most common cancer in women worldwide, after breast and colorectal cancer. Molecular biology has firmly established a causal relationship between persistent infection with high risk human papilloma virus (HPV) genotypes and cervical cancer.

Cervical cancer stage IB1 and selected IIA 1 lesions without extensive vaginal involvement can be treated with either RH and pelvic lymph node dissection (PLD) or primary chemoradiation.

Bladder dysfunction is the most common complication after radical hysterectomy. The incidence is approximate 10-80 %. Management of bladder dysfunction is continuous urethral catheterization or clean intermittent self-catheterization. Prolonged urethral catheterization may increase the risk of urinary tract infection.

Early postoperative bladder training that consist of a scheduled clamping trans-urethral catheter every 3 h and unclamping trans-urethral catheter 15 min during the entire day.

Bethanechol chloride is a cholinergic drug and may enhance the detrusor muscle contraction, resulting in higher maximum flow rate, and lower postvoid residual urine.

This study was conducted to compare the effectiveness of bethanechol chloride and early bladder training for prevention of bladder dysfunction after radical hysterectomy in cervical cancer stage IB - IIA.

Eligibility Criteria:
Inclusion Criteria:

* Women with cervical cancer stage IB - IIA underwent standard type III radical hysterectomy, both open and laparoscopic approach
* Patient aged 20 - 65 years
* Patient able to give free and informed consent and who agrees to participate be signing the consent form

Exclusion Criteria:

* Patient who had an allergic reaction to bethanechol chloride
* Patient who had neurogenic bladder
Early Childhood Caries in Jordanian Children

In this cross sectional epidemiological study, we aimed to report the prevalence of early childhood caries (ECC) in children attending kindergartens in Jordan, and its associated risk factors. We also, aimed to determine the effectiveness of silver diamine fluoride as a caries control material and its acceptance among parents of children with ECC. Children (n=887) with mean age 4.64 ± 1.56 were examined. Among this sample there was a number of children (n=159) who were enrolled in a randomized controlled trial to study silver diamine fluoride efficacy in caries control. The sample consisted of two groups; the study group (children who received single spot application of 38% SDF) and control group (children who were examined only).

Background: Early childhood caries is a well-known international public health challenge amongst young children.

Aims: To report the prevalence of early childhood caries in children attending kindergartens in Jordan, and its associated risk factors. To determine the effectiveness of silver diamine fluoride as a caries control material and its acceptance among parents of children with ECC.

Methods: This is a cross sectional epidemiological study comprised of children (n=887) with mean age 4.64 ± 1.56 who attended kindergartens of different cities in Jordan, this sample received questionnaires to fill data related to their demographic, socioeconomic, oral hygiene, oral health, nursing and nutritional habits. These children were also examined to determine early childhood caries prevalence in Jordan. Among this sample there was a number of children (n=159) with the mean age 4.8 ± 0.85 who were planned to be involved in a sample of a randomized controlled trial to study silver diamine fluoride efficacy in caries control. The sample consisted of two groups; the study group (children who received single spot application of 38% SDF) and control group (children who were examined only). Application of SDF started after distribution and receiving back approval letters from children's parents accompanied with questionnaires for data related to the approval/disapproval of the application. The sample were followed up for 1 year.

Eligibility Criteria:
Inclusion Criteria:

* Children with early childhood caries involving anterior and/or posterior primary teeth
* Children with with cavitated lesions with active caries
* Children with no clinical signs of pulp involvement

Exclusion criteria:

* Children with grossly broken down teeth
* Children with teeth with more than one third of the crown missing
* Children with pulpally involved teeth (with pulp exposure, presence of an abscess or a sinus) Children with obvious discoloration, and abnormal mobility
Egyptian Women Knowledge and Use of Different Contraceptive Methods

Starting from Jan 2012 for an interval of 4 months with minimum number of 1200 egyptian women will be asked to complete a questionairre to evaluate their knowledge of different contraceptive methods

PATIENTS AND METHODS

Sample size, Time of the study:

Starting from Jan 2012 for an interval of 4 months with minimum number of 1200women .

Type of the study:

Analytical crossectional study

Place of the study:

Ain Shams University Hospital, Gynecological outpatient clinic and Amireya primary care medical center (family planning clinic).

Statistical methodology:

SPSS program will be used for data analysis. Appropriate significance tests will be used according to type of data.

After an oral consent is taken from them, Women will be asked to complete a short written questionnaire that includes social data, reproductive information, and some questions about common contraceptive methods.

Testing readability and comprehension of the questionnaire will be done first by collecting 50 questionnaires and analyzing the data.

AIM OF THE WORK The aim of this study is to evaluate knowledge and use of different available contraceptive methods among women attending Ain Shams University maternity hospital in the gynecological outpatient clinic and Amireya primary care medical center (family planning clinic).

Eligibility Criteria:
Inclusion Criteria:

1. Age : 18 -51 years old
2. Using a contraceptive method for at least 6 months continuously.

Exclusion Criteria:

1. Infertile
2. Vaginal bleeding of unknown etiology.
3. Current pregnancy
4. Menopausal
Impact of Vitamin A on Multiple Sclerosis (MS)

The aim of this study is the comparison between the effects of supplementation with 25000 IU preformed vitamin A (retinyl palmitate) or placebo for first 6 months and 10000 IU/day for next 6 months on disease activity and progression in patients with Multiple Sclerosis.

Multiple Sclerosis (MS) is a chronic inflammatory disease where Th1 like responses from myelin-specific CD4+ T cells, as secretion of pro-inflammatory IFNγ, are believed to play a major role in the pathogenesis. The myelin-specific T cells that mediate tissue destruction in MS are believed to become activated outside the central nervous system (CNS) in lymphoid tissue and when they cross the blood brain barrier they will re-encounter their antigen. Immune deviation is the redirection of the immune response from most often Th1 like responses to Th2 like responses, even though the opposite can also occur. Vitamin A or Vitamin A-like analogs known as retinoids, are potent hormonal modifiers of type 1 or type 2 responses but a definitive description of their mechanism(s) of action is lacking. High level dietary vitamin A enhances Th2 cytokine production and IgA responses, and is likely to decrease Th1 cytokine production. Retinoic acid(RA) inhibits IL12 production in activated macrophages, and RA pretreatment of macrophages reduces IFNγ production and increases IL4 production in antigen primed CD4 T cells. Supplemental treatment with vitamin A or RA decreases IFNγ and increases IL5, IL10, and IL4 production.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have used interferon beta in last 3 months
* Patients with 0-5 EDSS

Exclusion Criteria:

* Patients who have diseases which affect on Th1/Th2 balance such as asthma, active viral infections, and autoimmune diseases, OR

  * Patients who have allergy to vitamin A compounds, OR
  * Patients who have used vitamin supplements in last 3 months.
Comparison of Implant Positioning With Robotic Aided Surgery and Traditional Jig Positioning in Total Knee Arthroplasty

The purpose of this study is to compare the outcomes and accuracy of implant positioning in robotic assisted total knee arthroplasty with traditional manually instrumented total knee arthroplasty.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have knee pain and are candidates for total knee arthroplasty
* Patients able to consent to be included in the study

Exclusion Criteria:

* Patients with previous total or partial knee arthroplasty in need of revision surgery
* Patients unable to or unwilling to undergo post-operative CT scans after understanding the risks and benefits
XIENCE Xpedition/Alpine/Sierra in Routine Clinical Practice

The purpose of this study is to evaluate effectiveness and safety of XIENCE Xpedition/Alpine/Sierra in Routine Clinical Practice


Eligibility Criteria:
Inclusion Criteria:

* Age 19 and more
* Intervention with XIENCE Xpedition or Alpine or Sierra everolimus eluting coronary stent
* Agreed with written informed consent form

Exclusion Criteria:

* Intervention with XIENCE Xpedition or Alpine or Sierra everolimus eluting coronary stent and other drug eluting stent at the same time
* Life expectancy of 1year and under
* Cardiac shock
Expanded Access to Cefiderocol for the Intravenous Treatment of Severe Gram Negative Bacterial Infections

Expanded access may be provided for cefiderocol for qualified patients who have limited treatment options and are not eligible for a clinical trial.


Eligibility Criteria:
Hospitalized patients with serious Gram-negative bacterial infections and who have limited treatment options and are not eligible for a clinical trial.
AchE Inhibitor and Insulin

The investigator will examine the effect of a single dose of pyridostigmine, AchE inhibitor on insulin secretion in healthy subjects. Each subject will undergo an intravenous glucose tolerance test (IVGTT) where IV glucose will be administered and the glucose excursion and insulin secretion response will be evaluated by measuring insulin and glucose at different time points. The test will be carried out twice, once without and once with the administration of a single dose of Pyridostigmine on two separate days. The investigator hypothesizes that inhibiting AChE will potentiate insulin secretion.


Eligibility Criteria:
Inclusion Criteria:

* 18 years and older

Exclusion Criteria:

* BMI \>30 Kg/m2
* fasting glucose \>100
* Glycohemoglobin (Hemoglobin A1C) 5.7% or more
* History of asthma
* Use of medications that may interfere with glucose metabolism
Efficacy of Ultrasound Guided Erector Spinae Plane Block

Thoracic epidural and paravertebral blocks are the most widely regional technique used for postoperative analgesia after surgery, but they are difficult to perform and carry a risk of serious complication. In this study, investigator asses the efficacy of ultrasound ESPB on intraoperative and postoperative hemodynamics and patient satisfaction

This prospective, double-blinded, randomized, controlled study was conducted at the period from October 2018 to December 2019. Sixty adults' patients ASA I-III, their ages ranged from 25-60 years undergoing abdominal surgery under general anesthesia. Each patient assigned written informed consent before the block performance.

Patients refused, known allergy to the used drugs, with history of coagulopathy, major organ failure and obesity (BMI\>40 kg/m2) were excluded from the study.

Patients were randomly allocated into two equal groups by a computerized randomization table: ESPB group, and control group. The patient and the staff providing the postoperative care were blinded to the group assignment.

ESPB group: Will undergo ESP block with 40 ml bupivacaine 0.25% (20 ml on each side) control group: anesthetized with the protocol followed by Minia University Hospital.

Anesthetic technique was standardized for all patients.

Eligibility Criteria:
Inclusion Criteria:

1. Age18-70 .
2. Both gender.

4. ASA I-III .

Exclusion Criteria:

1. patient refuse
2. Drug allergy.
3. Morbid obesity (BMI \>40 kg/m2).
4. Psychiatric disorder.
5. Opioid dependence .